,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32343193,Recruiting young women of color into a pilot RCT targeting sexual health: Lessons learned and implications for applied health technology research.,"Objective: To evaluate different recruitment methods to enroll participants into a mHealth pilot RCT: banner ads on Facebook and OkCupid, and targeted electronic outreach (e.g., emails to community-based organizations and to professors at local colleges). Participants: Between October 2015 and May 2016, 114 college-aged Black and Latina women 18 to 24 participated in the study. Methods: Recruitment methods compared online banner ads on social media to targeted electronic outreach. Individual banner ad images were compared by impressions, clicks, and cost by enrolled participants. Results: More targeted electronic recruited participants enrolled than via banner advertisements. Banner ads with images of women yielded a higher click-through-rate and was more cost effective versus the logo alone. Conclusions: Recruiting young women of color may be facilitated through known and trusted adults, such as college professors, rather than through anonymous banner advertisements on social media.",2020,Banner ads with images of women yielded a higher click-through-rate and was more cost effective versus the logo alone. ,"['enroll participants into a mHealth pilot RCT: banner ads on Facebook and OkCupid, and targeted electronic outreach (e.g., emails to community-based organizations and to professors at local colleges', '114 college-aged Black and Latina women 18 to 24 participated in the study', 'Participants: Between October 2015 and May 2016']",['online banner ads on social media to targeted electronic outreach'],[],"[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}]",[],,0.068095,Banner ads with images of women yielded a higher click-through-rate and was more cost effective versus the logo alone. ,"[{'ForeName': 'Sonia K', 'Initials': 'SK', 'LastName': 'González', 'Affiliation': 'Center for Health Technology, Hunter College, New York, New York, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grov', 'Affiliation': 'Department of Community Health and Social Sciences, CUNY Graduate School of Public Health and Health Policy & the CUNY Institute for Implementation Science in Population Health, New York, New York, USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2020.1746663']
1,32339359,A Pilot Randomized Controlled Trial of the PTSD Coach App Following Motor Vehicle Crash-related Injury.,"OBJECTIVE
Posttraumatic stress disorder (PTSD) symptoms (PTSS) are common after minor injuries and can impair recovery. We sought to understand whether an evidence-based mobile phone application with self-help tools (PTSD Coach) could be useful to improve recovery after acute trauma among injured emergency department (ED) patients. This pilot study examined the feasibility, acceptability, and potential benefit of using PTSD Coach among acutely injured motor vehicle crash (MVC) patients.
METHODS
From September 2017 to September 2018, we recruited adult patients within 24 hours post-MVC from the EDs of two Level I trauma centers in the United States. We randomly assigned 64 injured adults to either the PTSD Coach (n = 33) or treatment as usual (TAU; n = 31) condition. We assessed PTSS and associated symptoms at 1 month (83% retained) and 3 months (73% retained) postenrollment.
RESULTS
Enrollment was feasible (74% of eligible subjects participated) but usability and engagement were low (67% used PTSD Coach at least once, primarily in week 1); 76% of those who used it rated the app as moderately to extremely helpful. No differences emerged between groups in PTSS outcomes. Exploratory analyses among black subjects (n = 21) indicated that those in the PTSD Coach condition (vs. TAU) reported marginally lower PTSS (95% CI = -0.30 to 37.77) and higher PTSS coping self-efficacy (95% CI = -58.20 to -3.61) at 3 months.
CONCLUSIONS
We demonstrated feasibility to recruit acutely injured ED patients into an app-based intervention study, yet mixed evidence emerged for the usability and benefit of PTSD Coach. Most patients used the app once and rated it favorably in regard to satisfaction with and helpfulness, but longitudinal engagement was low. This latter finding may explain the lack of overall effects on PTSS. Additional research is warranted regarding whether targeting more symptomatic patients and the addition of engagement and support features can improve efficacy.",2020,No differences emerged between groups in PTSS outcomes.,"['64 injured adults to either the', 'acute trauma among injured emergency department (ED) patients', 'acutely injured motor-vehicle crash (MVC) patients', 'From September 2017-September 2018', 'adult patients within 24 hours post-MVC from the EDs of two Level 1 trauma centers in the United States', 'Black subjects (n = 21']","['evidence-based mobile phone application with self-help tools (PTSD Coach', 'PTSD Coach']","['PTSS coping self-efficacy', 'PTSD symptoms (PTSS) and associated symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175845', 'cui_str': 'Motor vehicle'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0557773', 'cui_str': 'Coach'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}]",64.0,0.242411,No differences emerged between groups in PTSS outcomes.,"[{'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Pacella-LaBarbara', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Suffoletto', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Kuhn', 'Affiliation': 'the, Dissemination and Training Division, National Center for PTSD, Palo Alto, CA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Germain', 'Affiliation': 'and the, Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Stephany', 'Initials': 'S', 'LastName': 'Jaramillo', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Repine', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Clifton W', 'Initials': 'CW', 'LastName': 'Callaway', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14000']
2,32340871,Effect of aspirin dose on hemocompatibility-related outcomes with a magnetically levitated left ventricular assist device: An analysis from the MOMENTUM 3 study.,"BACKGROUND
Aspirin (ASA) anti-platelet therapy is mandated with left ventricular assist devices (LVADs) to prevent hemocompatibility-related adverse events (HRAEs). However, the optimal dose of ASA with HeartMate 3 (HM3) LVAD is unknown.
METHODS
In an exploratory analysis of HM3-supported patients in the MOMENTUM 3 study (NCT02224755), 2 groups were analyzed: usual-dose (325 mg) and low-dose (81 mg) ASA with anti-coagulation targeted to an international normalized ratio of 2.0 to 3.0. Exclusion criteria included patients not receiving either ASA 81 mg or 325 mg, those with HRAEs ≤7 days after device implantation, and those receiving >1 anti-platelet agent. The primary end-point was survival free from HRAEs (non-surgical bleeding, pump thrombosis, stroke, and peripheral arterial thromboembolic events) at 2 years.
RESULTS
Overall, 321 HM3 patients (usual-dose: n = 141, low-dose: n = 180) were included in this analysis. Usual-dose group patients were younger (57 ± 13 vs 60 ± 12 years, p = 0.035) and less often assigned destination therapy (55% vs 67%, p = 0.029) than low-dose ASA. At 2 years, a similar proportion of patients in the usual- and low-dose groups (43.4% vs 45.3%, p = 0.94) met the primary end-point. There were no differences in survival free from hemorrhagic (usual-dose: 54.4% vs low-dose: 51.7%, p = 0.42) or thrombotic (usual-dose: 76.8% vs low-dose: 75.7%, p = 0.92) events.
CONCLUSIONS
Usual- and low-dose ASA revealed similar rates of bleeding and thrombotic events in HM3 LVAD-supported patients within the MOMENTUM 3 trial. Whether ASA therapy provides any meaningful therapeutic effect in patients treated by the HM3 LVAD remains to be determined.",2020,"Usual-dose group patients were younger (57 ± 13 vs 60 ± 12 years, p = 0.035) and less often assigned destination therapy (55% vs 67%, p = 0.029) than low-dose ASA.","['321 HM3 patients (usual-dose: n\u202f=\u202f141, low-dose: n\u202f=\u202f180']","['Aspirin (ASA) anti-platelet therapy', 'ASA', 'aspirin']","['thrombotic', 'survival free from HRAEs (non-surgical bleeding, pump thrombosis, stroke, and peripheral arterial thromboembolic events', 'rates of bleeding and thrombotic events', 'survival free from hemorrhagic']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}]",180.0,0.064419,"Usual-dose group patients were younger (57 ± 13 vs 60 ± 12 years, p = 0.035) and less often assigned destination therapy (55% vs 67%, p = 0.029) than low-dose ASA.","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Saeed', 'Affiliation': 'Department of Medicine and Department of Cardiothoracic and Vascular Surgery, Montefiore-Einstein Center for Heart and Vascular Care, Bronx, New York.'}, {'ForeName': 'Paolo C', 'Initials': 'PC', 'LastName': 'Colombo', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Uriel', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Goldstein', 'Affiliation': 'Department of Medicine and Department of Cardiothoracic and Vascular Surgery, Montefiore-Einstein Center for Heart and Vascular Care, Bronx, New York.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cleveland', 'Affiliation': 'Department of Surgery, University of Colorado Hospital, Aurora, Colorado.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Samer S', 'Initials': 'SS', 'LastName': 'Najjar', 'Affiliation': 'Department of Medicine, Medstar Washington Hospital Center, Washington, District of Columbia.'}, {'ForeName': 'Nahush A', 'Initials': 'NA', 'LastName': 'Mokadam', 'Affiliation': 'Department of Surgery, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Department of Surgery, Ochsner Medical Center, New Orleans, Louisiana.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Crandall', 'Affiliation': 'Division of Cardiology Department of Medicine, Abbott, Chicago, Illinois.'}, {'ForeName': 'Poornima', 'Initials': 'P', 'LastName': 'Sood', 'Affiliation': 'Division of Cardiology Department of Medicine, Abbott, Chicago, Illinois.'}, {'ForeName': 'Ulrich P', 'Initials': 'UP', 'LastName': 'Jorde', 'Affiliation': 'Department of Medicine and Department of Cardiothoracic and Vascular Surgery, Montefiore-Einstein Center for Heart and Vascular Care, Bronx, New York. Electronic address: ujorde@montefiore.org.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.03.001']
3,32346965,"Does deep sedation with analgesia have positive effects on anxiety, pain and compliance in patients before and after prostate biopsy?","AIMS
To investigate whether deep sedation for transrectal prostate biopsy could reduce anxiety and pain and enhance rebiopsy compliance.
METHODS
A two-centre prospective observation study was conducted under two different anaesthetic conditions: deep sedation with analgesia and local anaesthesia with lidocaine. A 12-core prostate biopsy was taken in all patients. Scores on a 0-10 visual analogue scale, the State-Trait Anxiety Inventory-X-1, the Beck Anxiety Inventory and a five-level Likert satisfaction scale were evaluated. Finally, all patients were asked about their willingness to undergo the same procedure again if necessary and whether they wanted to change the anaesthetic method (deep sedation to local anaesthesia or local to sedation) if a repeat procedure was required.
RESULTS
A total of 135 patients were included in this study, including 69 patients in the sedation group and 66 patients in the local group. Lower pain scores (P < .001) and higher satisfaction scores (P = .019) were observed in the sedation group than in the local group after the procedure. Anxiety scores in the sedation group were significantly decreased after the procedure, whereas those were not changed in the local group. The question regarding rebiopsy compliance tended to be more positive in the sedation than in the local group (73.9% vs 62.1%, respectively, P = .099). The proportion of patients who wanted to change their anaesthetic method was much higher in the local than in the sedation group (68.2% vs 11.6%, respectively, P < .001).
CONCLUSION
Deep sedation with analgesia during transrectal prostate biopsy could reduce pain and postprocedural anxiety and enhance rebiopsy compliance. Considering the psychological and oncological benefits, we strongly recommend inducing deep sedation during transrectal prostate biopsy.",2020,Lower pain scores (P < .001) and higher satisfaction scores (P = .019) were observed in the sedation group than in the local group after the procedure.,"['A total of 135 patients were included in this study, including 69 patients in the sedation group and 66 patients in the local group', 'A two-centre prospective observation study was conducted under two different anaesthetic conditions']","['anaesthetic method (deep sedation to local anaesthesia or local to sedation', 'deep sedation with analgesia and local anaesthesia with lidocaine']","['pain and postprocedural anxiety and enhance rebiopsy compliance', 'anxiety, pain and compliance', 'Lower pain scores', 'Anxiety scores', 'anxiety and pain and enhance rebiopsy compliance', 'higher satisfaction scores', 'Scores on a 0-10 visual analogue scale, the State-Trait Anxiety Inventory-X-1, the Beck Anxiety Inventory and a five-level Likert satisfaction scale']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1956064', 'cui_str': 'Sedation, Deep'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",135.0,0.0366582,Lower pain scores (P < .001) and higher satisfaction scores (P = .019) were observed in the sedation group than in the local group after the procedure.,"[{'ForeName': 'Min Soo', 'Initials': 'MS', 'LastName': 'Choo', 'Affiliation': 'Department of Urology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Sup', 'Initials': 'DS', 'LastName': 'Lee', 'Affiliation': ""Department of Urology, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Republic of Korea.""}]",International journal of clinical practice,['10.1111/ijcp.13517']
4,32279416,Preoperative evaluation of microvascular invasion with circulating tumour DNA in operable hepatocellular carcinoma.,"BACKGROUND & AIMS
Microvascular invasion (MVI) is a critical prognostic factor for operable hepatocellular carcinoma (HCC). This study aimed to explore the performance of circulating tumour DNA (ctDNA) in evaluating MVI status preoperatively.
METHODS
Seventy-three HCC patients were enrolled and randomly divided into a training cohort and a validation cohort in a 2:1 ratio, and preoperative blood and surgical tissue samples were obtained. Genomic alterations were analysed using targeted deep sequencing with a 1021-gene panel.
RESULTS
In training cohort, 260 somatic mutations were identified in 40 blood samples (81.6%). CtDNA mutation was verified in paired tissue sample in 39 patients (97.5%). In univariate analysis, ctDNA allele frequency (AF) and largest tumour diameter were associated with the presence of MVI, but ctDNA AF was the only independent risk factor in multivariate analysis. With the cut-off value of 0.83%, ctDNA AF determined the presence of MVI with the sensitivity of 89.7% and specificity of 80.0% in the training cohort, and the sensitivity of 78.6% and the specificity of 81.8% in the validation cohort. In preoperative evaluation, ctDNA AF, AFP level and BCLC staging were associated with recurrence-free survival in both univariate and multivariate analysis.
CONCLUSIONS
CtDNA can serve as an independent risk factor of MVI for operable HCC and help determining precise treatment strategies. The integration of ctDNA in the management of operable HCC may achieve better clinical outcomes.",2020,"In univariate analysis, ctDNA allele frequency (AF) and largest tumor diameter were associated with the presence of MVI, but ctDNA AF was the only independent risk factor in multivariate analysis.","['operable hepatocellular carcinoma (HCC', 'Seventy-three HCC patients', 'operable hepatocellular carcinoma']",[],"['recurrence-free survival', 'ctDNA AF, AFP level and BCLC staging']","[{'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0017270', 'cui_str': 'Gene frequency'}, {'cui': 'C0201539', 'cui_str': 'Alpha-1-Fetoprotein measurement'}, {'cui': 'C0332305', 'cui_str': 'With staging'}]",260.0,0.0294222,"In univariate analysis, ctDNA allele frequency (AF) and largest tumor diameter were associated with the presence of MVI, but ctDNA AF was the only independent risk factor in multivariate analysis.","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Goldstein', 'Affiliation': 'Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Ye', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Lianpeng', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Guan', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Long', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Qiongzhi', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yi', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Xia', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Ledu', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14463']
5,32347764,Air Pollutant Exposure and Stove Use Assessment Methods for the Household Air Pollution Intervention Network (HAPIN) Trial.,"BACKGROUND
High quality personal exposure data is fundamental to understanding the health implications of household energy interventions, interpreting analyses across assigned study arms, and characterizing exposure-response relationships for household air pollution. This paper describes the exposure data collection for the Household Air Pollution Intervention Network (HAPIN), a multicountry randomized controlled trial of liquefied petroleum gas stoves and fuel among 3,200 households in India, Rwanda, Guatemala, and Peru.
OBJECTIVES
The primary objectives of the exposure assessment are to estimate the exposure contrast achieved following a clean fuel intervention and to provide data for analyses of exposure-response relationships across a range of personal exposures.
METHODS
Exposure measurements are being conducted over the 3-y time frame of the field study. We are measuring fine particulate matter [PM < 2.5 μ m in aerodynamic diameter ( PM 2.5 )] with the Enhanced Children's MicroPEM™ (RTI International), carbon monoxide (CO) with the USB-EL-CO (Lascar Electronics), and black carbon with the OT21 transmissometer (Magee Scientific) in pregnant women, adult women, and children < 1 year of age, primarily via multiple 24-h personal assessments (three, six, and three measurements, respectively) over the course of the 18-month follow-up period using lightweight monitors. For children we are using an indirect measurement approach, combining data from area monitors and locator devices worn by the child. For a subsample (up to 10%) of the study population, we are doubling the frequency of measurements in order to estimate the accuracy of subject-specific typical exposure estimates. In addition, we are conducting ambient air monitoring to help characterize potential contributions of PM 2.5 exposure from background concentration. Stove use monitors (Geocene) are being used to assess compliance with the intervention, given that stove stacking (use of traditional stoves in addition to the intervention gas stove) may occur.
CONCLUSIONS
The tools and approaches being used for HAPIN to estimate personal exposures build on previous efforts and take advantage of new technologies. In addition to providing key personal exposure data for this study, we hope the application and learnings from our exposure assessment will help inform future efforts to characterize exposure to household air pollution and for other contexts. https://doi.org/10.1289/EHP6422.",2020,"[PM < 2.5 μ m in aerodynamic diameter ( PM 2.5 )] with the Enhanced Children's MicroPEM™ (RTI International), carbon monoxide (CO) with the USB-EL-CO (Lascar Electronics), and black carbon with the OT21 transmissometer (Magee Scientific) in pregnant women, adult women, and children ","['3,200 households in India, Rwanda, Guatemala, and Peru', 'pregnant women, adult women, and children']",['liquefied petroleum gas stoves'],[],"[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}]",[],3200.0,0.0431358,"[PM < 2.5 μ m in aerodynamic diameter ( PM 2.5 )] with the Enhanced Children's MicroPEM™ (RTI International), carbon monoxide (CO) with the USB-EL-CO (Lascar Electronics), and black carbon with the OT21 transmissometer (Magee Scientific) in pregnant women, adult women, and children ","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Johnson', 'Affiliation': 'Berkeley Air Monitoring Group, Berkeley, California, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Steenland', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Piedrahita', 'Affiliation': 'Berkeley Air Monitoring Group, Berkeley, California, USA.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Clark', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Pillarisetti', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Peel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Luke P', 'Initials': 'LP', 'LastName': 'Naeher', 'Affiliation': 'Department of Environmental Health Science, College of Public Health, University of Georgia, Athens, Georgia, USA.'}, {'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'Geocene, Vallejo, California, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Sarnat', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Lindsay J', 'Initials': 'LJ', 'LastName': 'Underhill', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Burrowes', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'McCracken', 'Affiliation': 'Center for Health Studies, Universidad del Valle de Guatemala, Guatemala City, Guatemala.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Rosa', 'Affiliation': 'Department of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rosenthal', 'Affiliation': 'Division of Epidemiology and Population Studies, Fogarty International Center, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Sankar', 'Initials': 'S', 'LastName': 'Sambandam', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'de Leon', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Miles A', 'Initials': 'MA', 'LastName': 'Kirby', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kearns', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clasen', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environmental health perspectives,['10.1289/EHP6422']
6,32347765,Design and Rationale of the Biomarker Center of the Household Air Pollution Intervention Network (HAPIN) Trial.,"BACKGROUND
Biomarkers of exposure, susceptibility, and effect are fundamental for understanding environmental exposures, mechanistic pathways of effect, and monitoring early adverse outcomes. To date, no study has comprehensively evaluated a large suite and variety of biomarkers in household air pollution (HAP) studies in concert with exposure and outcome data. The Household Air Pollution Intervention Network (HAPIN) trial is a liquified petroleum gas (LPG) fuel/stove randomized intervention trial enrolling 800 pregnant women in each of four countries (i.e., Peru, Guatemala, Rwanda, and India). Their offspring will be followed from birth through 12 months of age to evaluate the role of pre- and postnatal exposure to HAP from biomass burning cookstoves in the control arm and LPG stoves in the intervention arm on growth and respiratory outcomes. In addition, up to 200 older adult women per site are being recruited in the same households to evaluate indicators of cardiopulmonary, metabolic, and cancer outcomes.
OBJECTIVES
Here we describe the rationale and ultimate design of a comprehensive biomarker plan to enable us to explore more fully how exposure is related to disease outcome.
METHODS
HAPIN enrollment and data collection began in May 2018 and will continue through August 2021. As a part of data collection, dried blood spot (DBS) and urine samples are being collected three times during pregnancy in pregnant women and older adult women. DBS are collected at birth for the child. DBS and urine samples are being collected from the older adult women and children three times throughout the child's first year of life. Exposure biomarkers that will be longitudinally measured in all participants include urinary hydroxy-polycyclic aromatic hydrocarbons, volatile organic chemical metabolites, metals/metalloids, levoglucosan, and cotinine. Biomarkers of effect, including inflammation, endothelial and oxidative stress biomarkers, lung cancer markers, and other clinically relevant measures will be analyzed in urine, DBS, or blood products from the older adult women. Similarly, genomic/epigenetic markers, microbiome, and metabolomics will be measured in older adult women samples.
DISCUSSION
Our study design will yield a wealth of biomarker data to evaluate, in great detail, the link between exposures and health outcomes. In addition, our design is comprehensive and innovative by including cutting-edge measures such as metabolomics and epigenetics. https://doi.org/10.1289/EHP5751.",2020,"The Household Air Pollution Intervention Network (HAPIN) trial is a liquified petroleum gas (LPG) fuel/stove randomized intervention trial enrolling 800 pregnant women in each of four countries (i.e., Peru, Guatemala, Rwanda, and India).","['older adult women', 'HAPIN enrollment and data collection began in May 2018 and will continue through August 2021', 'pregnant women and older adult women', '800 pregnant women in each of four countries (i.e., Peru, Guatemala, Rwanda, and India', '200 older adult women per site are being recruited in the same households to evaluate indicators of cardiopulmonary, metabolic, and cancer outcomes', 'older adult women samples']",['https://doi.org/10.1289/EHP5751'],"['DBS and urine samples', 'inflammation, endothelial and oxidative stress biomarkers, lung cancer markers']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",[],"[{'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]",800.0,0.124554,"The Household Air Pollution Intervention Network (HAPIN) trial is a liquified petroleum gas (LPG) fuel/stove randomized intervention trial enrolling 800 pregnant women in each of four countries (i.e., Peru, Guatemala, Rwanda, and India).","[{'ForeName': 'Dana Boyd', 'Initials': 'DB', 'LastName': 'Barr', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Puttaswamy', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Jaacks', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Steenland', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rajkumar', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'Savannah', 'Initials': 'S', 'LastName': 'Gupton', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'P Barry', 'Initials': 'PB', 'LastName': 'Ryan', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Peel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clasen', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Clark', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environmental health perspectives,['10.1289/EHP5751']
7,32347766,Design and Rationale of the HAPIN Study: A Multicountry Randomized Controlled Trial to Assess the Effect of Liquefied Petroleum Gas Stove and Continuous Fuel Distribution.,"BACKGROUND
Globally, nearly 3 billion people rely on solid fuels for cooking and heating, the vast majority residing in low- and middle-income countries (LMICs). The resulting household air pollution (HAP) is a leading environmental risk factor, accounting for an estimated 1.6 million premature deaths annually. Previous interventions of cleaner stoves have often failed to reduce exposure to levels that produce meaningful health improvements. There have been no multicountry field trials with liquefied petroleum gas (LPG) stoves, likely the cleanest scalable intervention.
OBJECTIVE
This paper describes the design and methods of an ongoing randomized controlled trial (RCT) of LPG stove and fuel distribution in 3,200 households in 4 LMICs (India, Guatemala, Peru, and Rwanda).
METHODS
We are enrolling 800 pregnant women at each of the 4 international research centers from households using biomass fuels. We are randomly assigning households to receive LPG stoves, an 18-month supply of free LPG, and behavioral reinforcements to the control arm. The mother is being followed along with her child until the child is 1 year old. Older adult women (40 to < 80 years of age) living in the same households are also enrolled and followed during the same period. Primary health outcomes are low birth weight, severe pneumonia incidence, stunting in the child, and high blood pressure (BP) in the older adult woman. Secondary health outcomes are also being assessed. We are assessing stove and fuel use, conducting repeated personal and kitchen exposure assessments of fine particulate matter with aerodynamic diameter ≤ 2.5 μ m ( PM 2.5 ), carbon monoxide (CO), and black carbon (BC), and collecting dried blood spots (DBS) and urinary samples for biomarker analysis. Enrollment and data collection began in May 2018 and will continue through August 2021. The trial is registered with ClinicalTrials.gov (NCT02944682).
CONCLUSIONS
This study will provide evidence to inform national and global policies on scaling up LPG stove use among vulnerable populations. https://doi.org/10.1289/EHP6407.",2020,"Primary health outcomes are low birth weight, severe pneumonia incidence, stunting in the child, and high blood pressure (BP) in the older adult woman.","['800 pregnant women at each of the 4 international research centers from households using biomass fuels', '3,200 households in 4 LMICs (India, Guatemala, Peru, and Rwanda', 'Older adult women (40 to < 80 \u2009 years of age) living in the same households are also enrolled and followed during the same period']","['Liquefied Petroleum Gas Stove and Continuous Fuel Distribution', 'LPG stoves', 'LPG stove and fuel distribution']","['low birth weight, severe pneumonia incidence, stunting in the child, and high blood pressure (BP', 'household air pollution (HAP', 'carbon monoxide (CO), and black carbon (BC), and collecting dried blood spots (DBS) and urinary samples for biomarker analysis']","[{'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]","[{'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0007010', 'cui_str': 'Carbon Black'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",800.0,0.14481,"Primary health outcomes are low birth weight, severe pneumonia incidence, stunting in the child, and high blood pressure (BP) in the older adult woman.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clasen', 'Affiliation': 'Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Peel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, Tamil Nadu, India.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'McCracken', 'Affiliation': 'Center for Health Studies, Universidad del Valle de Guatemala, Guatemala City, Guatemala.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Rosa', 'Affiliation': 'Department of Disease Control, Faculty of Infections and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Thompson', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Dana Boyd', 'Initials': 'DB', 'LastName': 'Barr', 'Affiliation': 'Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Clark', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Johnson', 'Affiliation': 'Berkeley Air Monitoring Group, Berkeley, California, USA.'}, {'ForeName': 'Lance A', 'Initials': 'LA', 'LastName': 'Waller', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Jaacks', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Steenland', 'Affiliation': 'Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Miranda', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Chang', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Dong-Yun', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Office of Biostatistics Research, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'Eudowood Division of Respiratory Sciences, Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Victor G', 'Initials': 'VG', 'LastName': 'Davila-Roman', 'Affiliation': 'Cardiovascular Imaging and Clinical Research Core Laboratory, Cardiovascular Division, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Papageorghiou', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, UK.""}, {'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Rosenthal', 'Affiliation': 'Division of Epidemiology and Population Studies, Fogarty International Center, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environmental health perspectives,['10.1289/EHP6407']
8,32343765,A Diversified Dietary Pattern Is Associated With a Balanced Gut Microbial Composition of Faecalibacterium and Escherichia/Shigella in Patients With Crohn's Disease in Remission.,"BACKGROUND AND AIMS
Crohn's disease [CD] is associated with alterations in gut microbial composition and function. The present controlled-intervention study investigated the relationship between patterns of dietary intake and baseline gut microbiota in CD patients in remission and examined the effects of a dietary intervention in patients consuming a non-diversified diet [NDD].
METHODS
Forty outpatients with quiescent CD were recruited in Calgary, Alberta, Canada. Based on 3-day food records, patients consuming a lower plant-based and higher red and processed meat-based diet were assigned to the NDD group [n = 15] and received a 12-week structured dietary intervention; all other patients were assigned to the diversified diet [DD] control group [n = 25] and received conventional management. Faecal microbiota composition, short chain fatty acids [SCFAs] and calprotectin were measured.
RESULTS
At baseline the NDD and DD groups had a different faecal microbial beta-diversity [p = 0.003, permutational multivariate analysis of variance]. The NDD group had lower Faecalibacterium and higher Escherichia/Shigella relative abundances compared to the DD group [3.3 ± 5.4% vs. 8.5 ± 10.6%; 6.9 ± 12.2% vs. 1.6 ± 4.4%; p ≤ 0.03, analysis of covariance]. These two genera showed a strong negative correlation [rs = -0.60, q = 0.0002]. Faecal butyrate showed a positive correlation with Faecalibacterium [rs = 0.52, q = 0.002], and an inhibitory relationship with Escherichia/Shigella abundance [four-parameter sigmoidal model, R = -0.83; rs = -0.44, q = 0.01], respectively. After the 12 weeks of dietary intervention, no difference in microbial beta-diversity between the two groups was observed [p = 0.43]. The NDD group demonstrated an increase in Faecalibacterium [p < 0.05, generalized estimated equation model], and resembled the DD group at the end of the intervention [p = 0.84, t-test with permutation]. We did not find an association of diet with faecal SCFAs or calprotectin.
CONCLUSIONS
Dietary patterns are associated with specific gut microbial compositions in CD patients in remission. A diet intervention in patients consuming a NDD modifies gut microbial composition to resemble that seen in patients consuming a DD. These results show that diet is important in shaping the microbial dysbiosis signature in CD towards a balanced community.",2020,"The NDD group demonstrated an increase in Faecalibacterium (p<0.05, GEE), and resembled the DD group at the end of the intervention (p=0.84, t-test with permutation).","[""Crohn's disease (CD"", 'patients consuming a non-diversified diet (NDD', 'patients consuming a lower plant-based and higher red and processed meat-based diet were assigned to the NDD group (n=15) and received a', 'CD patients in remission', 'Forty outpatients with quiescent CD were recruited in Calgary, Alberta Canada', ""patients with Crohn's disease in remission""]","['diversified diet (DD) control group (n=25) and received conventional management', 'diet intervention', 'dietary intervention', '12-week structured dietary intervention']","['fecal microbial beta-diversity', 'Faecalibacterium (p<0.05, GEE', 'microbial beta-diversity', 'Fecal microbiota composition, short chain fatty acids (SCFAs) and calprotectin', 'inhibitory relationship with Escherichia/Shigella abundance', 'lower Faecalibacterium and higher Escherichia/Shigella relative abundances']","[{'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0331705', 'cui_str': 'Lower plant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0452956', 'cui_str': 'Processed meat'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1960764', 'cui_str': ""Crohn's disease in remission""}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C1229075', 'cui_str': 'Faecalibacterium'}, {'cui': 'C0267642', 'cui_str': 'Celiac infantilism'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0014833', 'cui_str': 'Escherichia'}, {'cui': 'C0013371', 'cui_str': 'Infection by Shigella'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",40.0,0.0229677,"The NDD group demonstrated an increase in Faecalibacterium (p<0.05, GEE), and resembled the DD group at the end of the intervention (p=0.84, t-test with permutation).","[{'ForeName': 'Zhengxiao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Lorian', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Shommu', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Subrata', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Institute of Translational Medicine, NIHR Biomedical Research Centre, University of Birmingham and Birmingham University Hospitals, Birmingham, UK.'}, {'ForeName': 'Raylene', 'Initials': 'R', 'LastName': 'Reimer', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Jae Eun', 'Initials': 'JE', 'LastName': 'Hyun', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Chenxi', 'Initials': 'C', 'LastName': 'Cai', 'Affiliation': ""Program for Pregnancy and Postpartum Health, Women and Children's Health Research Institute, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Deehan', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Hotte', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Madsen', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Maitreyi', 'Initials': 'M', 'LastName': 'Raman', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, AB, Canada.'}]",Journal of Crohn's & colitis,['10.1093/ecco-jcc/jjaa084']
9,32344324,"Cognitive Restructuring vs. Defusion: Impact on craving, healthy and unhealthy food intake.","Coping with food cravings is crucial for weight management. Individuals tend to use avoidance strategies to resist food cravings and prevent overeating, but such strategies may not result in the benefits sought. This study compared the effects of two cognitive techniques (Restructuring vs. Defusion) for dealing with food cravings in terms of their impact on healthy vs. unhealthy eating behavior (i.e., consumption of chocolate and/or carrots following the intervention). Sixty-five participants (M age = 19.65 years) received either a 30-minute face-to-face instruction on cognitive restructuring (CR) or cognitive defusion (CD) along with 15 min of practice, or 45 min of obesity education and discussion (control). To examine craving and eating choices following the intervention, participants received bags of chocolate and carrots and were asked to carry these with them at all times over the next week, exchanging the bags every 2 days. Participants in the CD group ate fewer chocolates (M = 11.74) compared to CR (M = 17.06) and Control groups (M = 29.18) during the experimental week. The groups did not differ in number of carrot pieces eaten, though the CD group ate more carrots than chocolates. CD resulted in fewer self-reported cravings compared to CR and CO groups. At a final taste test, both CD and CR groups ate significantly fewer chocolates compared to the CO group. CD appears to be an effective technique in managing food craving and to present some advantages over CR.",2020,"The groups did not differ in number of carrot pieces eaten, though the CD group ate more carrots than chocolates.",['Sixty-five participants (M age \xa0'],"['bags of chocolate and carrots', '30-minute face-to-face instruction on cognitive restructuring (CR) or cognitive defusion (CD) along with 15\xa0min of practice, or 45\xa0min of obesity education and discussion (control', 'CD', 'cognitive techniques (Restructuring vs. Defusion', 'Cognitive Restructuring vs. Defusion']",[],"[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C1141640', 'cui_str': 'Carrot'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],65.0,0.020642,"The groups did not differ in number of carrot pieces eaten, though the CD group ate more carrots than chocolates.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Karekla', 'Affiliation': 'University of Cyprus, Cyprus. Electronic address: mkarekla@ucy.ac.cy.'}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Georgiou', 'Affiliation': 'University of Cyprus, Cyprus.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Panayiotou', 'Affiliation': 'University of Cyprus, Cyprus.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Sandoz', 'Affiliation': 'University of Louisiana at Lafayette, United States of America.'}, {'ForeName': 'A Solomon', 'Initials': 'AS', 'LastName': 'Kurz', 'Affiliation': 'VISN 17 Center of Excellence for Research on Returning War Veterans, Central Texas Veterans Health Care System, United States of America.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Constantinou', 'Affiliation': 'University of Nicosia, Cyprus.'}]",Eating behaviors,['10.1016/j.eatbeh.2020.101385']
10,32343625,Executive function moderates naltrexone effects on methamphetamine-induced craving and subjective responses.,"Background : Emerging evidence suggests that opioid receptor antagonists, such as naltrexone, are effective pharmacotherapies for alcohol, opioid, and possibly stimulant use disorders. It is posited that naltrexone exerts its effects, in part, by increasing functional connectivity between neural reward circuitry and frontal systems implicated in executive function. Yet no studies had examined whether executive function moderates these effects. Objectives : This study examined whether a composite measure of executive function (EF) moderates the effect of naltrexone on craving for methamphetamine and subjective responses following infusion of the drug. Methods : Individuals with methamphetamine use disorder (N = 30; 27% female) completed baseline neurocognitive assessments of premorbid and executive function, and an executive function factor was computed. Participants then underwent a randomized, double-blind, cross-over study of titration with naltrexone and placebo. Participants then received a 30-mg intravenous methamphetamine infusion and completed subjective response questionnaires at 8 times in the 120 minutes post-infusion. Results : Multilevel mixed models indicated a significant EF × medication interaction, reflecting greater effects of naltrexone to decrease ""desire to access the drug"", ""want more of the drug"", ""crave the drug"", ""feel drug effects"" and ""feel high"" in participants with low EF compared to those with high EF (Bs = .36-1.29, SEs = .14-.17, ps <0.01). These effects remained significant after controlling for premorbid cognitive functioning, baseline responses to methamphetamine, severity of methamphetamine use, and methamphetamine-related functional problems. Conclusion : Naltrexone may be especially effective in methamphetamine-dependent individuals with low EF. Neuropsychological assessments may also provide predictive clinical utility not captured by traditional measures of substance use severity.",2020,"These effects remained significant after controlling for premorbid cognitive functioning, baseline responses to methamphetamine, severity of methamphetamine use, and methamphetamine-related functional problems.","['methamphetamine-dependent individuals with low EF', 'Methods : Individuals with methamphetamine use disorder (N = 30; 27% female']","['30-mg intravenous methamphetamine infusion', ' ', 'naltrexone', 'Naltrexone', 'naltrexone and placebo']",['methamphetamine-induced craving and subjective responses'],"[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",,0.14062,"These effects remained significant after controlling for premorbid cognitive functioning, baseline responses to methamphetamine, severity of methamphetamine use, and methamphetamine-related functional problems.","[{'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Lim', 'Affiliation': 'Department of Psychology, University of California , Los Angeles, CA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Grodin', 'Affiliation': 'Department of Psychology, University of California , Los Angeles, CA, USA.'}, {'ForeName': 'Rejoyce', 'Initials': 'R', 'LastName': 'Green', 'Affiliation': 'Department of Psychology, University of California , Los Angeles, CA, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Venegas', 'Affiliation': 'Department of Psychology, University of California , Los Angeles, CA, USA.'}, {'ForeName': 'Lindsay R', 'Initials': 'LR', 'LastName': 'Meredith', 'Affiliation': 'Department of Psychology, University of California , Los Angeles, CA, USA.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Courtney', 'Affiliation': 'Department of Psychology, University of California , San Diego, CA, USA.'}, {'ForeName': 'Nathasha R', 'Initials': 'NR', 'LastName': 'Moallem', 'Affiliation': 'Department of Psychology, University of California , Los Angeles, CA, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Sayegh', 'Affiliation': 'Department of Psychology, University of California , Los Angeles, CA, USA.'}, {'ForeName': 'Edythe D', 'Initials': 'ED', 'LastName': 'London', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California , Los Angeles, CA, USA.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, University of California , Los Angeles, CA, USA.'}]",The American journal of drug and alcohol abuse,['10.1080/00952990.2020.1741002']
11,32349922,Kinematic and kinetic comparison between American and Japanese collegiate pitchers.,"OBJECTIVES
Understanding the differences in baseball pitching biomechanics between American and Japanese pitchers may help with training and developing these athletes. The purpose of this study was to investigate the kinematic and kinetic differences in collegiate baseball pitchers from United States of American and Japan.
DESIGN
Controlled laboratory study.
METHODS
Data were analyzed for 11 American and 11 Japanese collegiate pitchers throwing fastballs using 3D motion capture (480Hz).
RESULTS
The Americans were heavier (95±7kg vs 81±7kg), taller (189±3cm vs 180±6cm), and had faster ball velocity (39±1m/s vs 35±2m/s). By the end of arm cocking phase, the American pitchers had rotated their shoulder to a greater degree (p=0.021, d=1.5) and at ball release the Japanese had greater knee flexion (p=0.020, d=1.2). American pitchers exhibited greater peak kinetics on the throwing arm; however, when normalized for height and weight only three differences remained.
CONCLUSION
The differences found between the American and Japanese players could contribute to the increased ball velocity in the American pitchers. Additionally, throwing arm peak kinetics were greater in the American pitchers which may help generate greater ball velocity; however, increased kinetics may also lead to increased risk of injury.",2020,"American pitchers exhibited greater peak kinetics on the throwing arm; however, when normalized for height and weight only three differences remained.
","['collegiate baseball pitchers from United States of American and Japan', 'Data were analyzed for 11 American and 11 Japanese collegiate pitchers throwing fastballs using 3D motion capture (480Hz', 'baseball pitching biomechanics between American and Japanese pitchers', 'American and Japanese collegiate pitchers']",[],"['peak kinetics', 'ball velocity', 'faster ball velocity', 'knee flexion']","[{'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}]",[],"[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}]",,0.022894,"American pitchers exhibited greater peak kinetics on the throwing arm; however, when normalized for height and weight only three differences remained.
","[{'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Dowling', 'Affiliation': 'Motus Global, Rockville Centre, NY, USA. Electronic address: Dowlingb86@gmail.com.'}, {'ForeName': 'Walter A', 'Initials': 'WA', 'LastName': 'Laughlin', 'Affiliation': 'Motus Global, Rockville Centre, NY, USA.'}, {'ForeName': 'Reed D', 'Initials': 'RD', 'LastName': 'Gurchiek', 'Affiliation': 'Motus Global, Rockville Centre, NY, USA.'}, {'ForeName': 'Caitlin P', 'Initials': 'CP', 'LastName': 'Owen', 'Affiliation': 'Motus Global, Rockville Centre, NY, USA.'}, {'ForeName': 'Micheal J', 'Initials': 'MJ', 'LastName': 'Luera', 'Affiliation': 'Applied Neuromuscular Physiology Laboratory, Oklahoma State University, Stillwater, OK, USA.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Hansen', 'Affiliation': 'Motus Global, Rockville Centre, NY, USA.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Fleisig', 'Affiliation': 'American Sports Medicine Institute, Birmingham, AL, USA.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.04.013']
12,32349711,Does ligation of the dorsal branch of the cephalic vein affect the patency of a distal forearm arteriovenous fistula? A randomised study.,"BACKGROUND
Whether ligation of the dorsal branch of the cephalic vein during the surgical establishment of the radiocephalic arteriovenous fistula (RCAVF) favorably or adversely affects the patency rate of the RCAVF remains controversial. We performed a randomized controlled trial to evaluate the effect of dorsal branch ligation on the patency rate of RCAVF.
METHODS
A total of 115 patients who underwent surgical establishment were randomized to two groups treated with or without ligation of the dorsal branch of the cephalic vein during the surgical process. The primary patency rates of the RCAVF at 90, 270, and 360 days after the surgery and the secondary patency rates during a follow-up up to 1 year were compared.
RESULTS
The patency rate did not differ significantly between the two groups at 3, 9, or 12 months after the procedure (P > 0.05). The combined primary patency rates of the RCAVF in patients from both groups at 3, 9 and 12 months after the procedure were 87.6, 82, and 74.5% respectively, while the combined secondary patency rate was 92.2% at the 1-year follow-up. The Log-rank test indicated that the initial patency rate and secondary patency rate did not differ significantly between the two groups (P = 0.674 and 0.759, respectively).
CONCLUSION
This clinical study indicated that ligation of the dorsal branch of the cephalic vein does not significantly affect the patency of the arteriovenous fistula with a 1-year follow-up.
TRIAL REGISTRATION
ISRCTN ISRCTN12288675, Registered 25 September 2019 in the ISRCTN registry. retrospectively registered.",2020,"The Log-rank test indicated that the initial patency rate and secondary patency rate did not differ significantly between the two groups (P = 0.674 and 0.759, respectively).
",['115 patients who underwent surgical establishment'],"['without ligation of the dorsal branch of the cephalic vein during the surgical process', 'dorsal branch ligation']","['patency rate of RCAVF', 'patency rate', 'secondary patency rates', 'patency rates of the RCAVF', 'initial patency rate and secondary patency rate', 'primary patency rates of the RCAVF']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0226802', 'cui_str': 'Structure of cephalic vein'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0205384', 'cui_str': 'Branching'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",115.0,0.0457406,"The Log-rank test indicated that the initial patency rate and secondary patency rate did not differ significantly between the two groups (P = 0.674 and 0.759, respectively).
","[{'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Blood Purification Center, The People's Hospital of Zhengzhou University, Zhengzhou, China.""}, {'ForeName': 'Guizhen', 'Initials': 'G', 'LastName': 'Zhu', 'Affiliation': ""Blood Purification Center, The People's Hospital of Zhengzhou University, Zhengzhou, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': ""Blood Purification Center, The People's Hospital of Zhengzhou University, Zhengzhou, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Blood Purification Center, The People's Hospital of Zhengzhou University, Zhengzhou, China.""}, {'ForeName': 'Fengmin', 'Initials': 'F', 'LastName': 'Shao', 'Affiliation': ""Blood Purification Center, The People's Hospital of Zhengzhou University, Zhengzhou, China. shaofengmin2013@126.com.""}]",BMC nephrology,['10.1186/s12882-020-01823-8']
13,32349761,Stand Out in Class: restructuring the classroom environment to reduce sitting time - findings from a pilot cluster randomised controlled trial.,"BACKGROUND
Excessive sedentary behaviour (sitting) is a risk factor for poor health in children and adults. Incorporating sit-stand desks in the classroom environment has been highlighted as a potential strategy to reduce children's sitting time. The primary aim of this study was to examine the feasibility of conducting a cluster randomised controlled trial (RCT) of a sit-stand desk intervention within primary school classrooms.
METHODS
We conducted a two-armed pilot cluster RCT involving 8 primary schools in Bradford, United Kingdom. Schools were randomised on a 1:1 basis to the intervention or usual practice control arm. All children (aged 9-10 years) in participating classes were eligible to take part. Six sit-stand desks replaced three standard desks (sitting 6 children) in the intervention classrooms for 4.5-months. Teachers were encouraged to use a rotation system to ensure all pupils were exposed to the sit-stand desks for > 1 h/day on average. Trial feasibility outcomes (assessed using quantitative and qualitative measures) included school and participant recruitment and attrition, intervention and outcome measure completion rates, acceptability, and preliminary effectiveness of the intervention for reducing sitting time. A weighted linear regression model compared changes in weekday sitting time (assessed using the activPAL accelerometer) between trial arms.
RESULTS
School and child recruitment rates were 33% (n = 8) and 75% (n = 176). At follow-up, retention rates were 100% for schools and 97% for children. Outcome measure completion rates ranged from 63 to 97%. A preliminary estimate of intervention effectiveness revealed a mean difference in change in sitting of - 30.6 min/day (95% CI: - 56.42 to - 4.84) in favour of the intervention group, after adjusting for baseline sitting and wear time. Qualitative measures revealed the intervention and evaluation procedures were acceptable to teachers and children, except for some problems with activPAL attachment.
CONCLUSION
This study provides evidence of the acceptability and feasibility of a sit-stand desk intervention and evaluation methods. Preliminary evidence suggests the intervention showed potential in reducing children's weekday sitting but some adaptations to the desk rotation system are needed to maximize exposure. Lessons learnt from this trial will inform the planning of a definitive trial.
TRIAL REGISTRATION
ISRCTN12915848 (registered: 09/11/16).",2020,"Qualitative measures revealed the intervention and evaluation procedures were acceptable to teachers and children, except for some problems with activPAL attachment.
","['children and adults', '8 primary schools in Bradford, United Kingdom', 'primary school classrooms', 'All children (aged 9-10\u2009years) in participating classes were eligible to take part']","['sit-stand desk intervention', 'sit-stand desk intervention and evaluation methods']","['weekday sitting time', 'retention rates', 'school and participant recruitment and attrition, intervention and outcome measure completion rates, acceptability, and preliminary effectiveness of the intervention for reducing sitting time']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",6.0,0.096541,"Qualitative measures revealed the intervention and evaluation procedures were acceptable to teachers and children, except for some problems with activPAL attachment.
","[{'ForeName': 'Stacy A', 'Initials': 'SA', 'LastName': 'Clemes', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK. S.A.Clemes@lboro.ac.uk.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Bingham', 'Affiliation': 'Bradford Institute for Health Research, Bradford Teaching Hospitals Foundation Trust, Bradford, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Pearson', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Yu-Ling', 'Initials': 'YL', 'LastName': 'Chen', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Edwardson', 'Affiliation': 'NIHR Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Rosemary R C', 'Initials': 'RRC', 'LastName': 'McEachan', 'Affiliation': 'Bradford Institute for Health Research, Bradford Teaching Hospitals Foundation Trust, Bradford, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Tolfrey', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Cale', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'Centre for Health Economics, University of York, Heslington, York, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Fray', 'Affiliation': 'Loughborough Design School, Loughborough University, Loughborough, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Altunkaya', 'Affiliation': 'Centre for Health Economics, University of York, Heslington, York, UK.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Bandelow', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Nishal Bhupendra', 'Initials': 'NB', 'LastName': 'Jaicim', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Salmon', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Barber', 'Affiliation': 'Bradford Institute for Health Research, Bradford Teaching Hospitals Foundation Trust, Bradford, UK.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-00958-z']
14,32350999,Evaluation of a novel telemedicine-based intervention to manage body image disturbance in head and neck cancer survivors.,"OBJECTIVES
The study aimed to evaluate the feasibility, acceptability, and preliminary clinical impact of BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment), a novel telemedicine-based cognitive-behavioral intervention to manage body image disturbance (BID) in head and neck cancer (HNC) survivors.
METHODS
Head and neck cancer survivors with BID were enrolled into a single-arm pilot trial. Participants completed study measures at baseline, 1- and 3-months post-BRIGHT to assess its acceptability and clinical impact. Participants completed semi-structured interviews to evaluate the feasibility and acceptability of BRIGHT and refine the intervention.
RESULTS
Ten HNC survivors with BID were enrolled into the trial of tablet-based BRIGHT. BRIGHT was feasible, as judged by low dropout (n = 1), high session completion rates (100%; 45/45) and low rates of technical issues with the tablet-based delivery (11% minor; 0% major). Ninety percent of participants were highly likely to recommend BRIGHT, reflecting its acceptability. BRIGHT was associated with a 34.5% reduction in mean Body Image Scale scores at 1-month post-BRIGHT (mean difference from baseline = 4.56; 95% CI 1.55, 7.56), an effect that was durable at 3-months post-BRIGHT (mean decrease from baseline = 3.56; 95% CI 1.15-5.96). Program evaluation revealed high levels of satisfaction with BRIGHT, particularly the delivery platform. During the qualitative evaluation, participants highlighted that BRIGHT improved image-related coping behavior.
CONCLUSIONS
BRIGHT is feasible, acceptable to HNC survivors, and has significant potential as a novel approach to manage BID in HNC survivors. Additional research is necessary to refine BRIGHT and evaluate its clinical efficacy and scalability.",2020,"BRIGHT was associated with a 34.5% reduction in mean Body Image Scale scores at 1-month post-BRIGHT (mean difference from baseline = 4.56; 95% CI 1.55, 7.56), an effect that was durable at 3-months post-BRIGHT (mean decrease from baseline = 3.56; 95% CI 1.15 to 5.96).","['Head and Neck Cancer Survivors', 'Ten HNC survivors with BID', 'head and neck cancer (HNC) survivors', 'HNC survivors with BID']","['Novel Telemedicine-Based Intervention', 'telemedicine-based cognitive-behavioral intervention']",['mean Body Image Scale scores'],"[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0558116', 'cui_str': 'Distorted body image'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0951576,"BRIGHT was associated with a 34.5% reduction in mean Body Image Scale scores at 1-month post-BRIGHT (mean difference from baseline = 4.56; 95% CI 1.55, 7.56), an effect that was durable at 3-months post-BRIGHT (mean decrease from baseline = 3.56; 95% CI 1.15 to 5.96).","[{'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Graboyes', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Maurer', 'Affiliation': 'Hollings Cancer Center, Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.'}, {'ForeName': 'Yeonhee', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Hollings Cancer Center, Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.'}, {'ForeName': 'Courtney H', 'Initials': 'CH', 'LastName': 'Marsh', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'McElligott', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.'}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Day', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Hornig', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Sterba', 'Affiliation': 'Hollings Cancer Center, Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.'}]",Psycho-oncology,['10.1002/pon.5399']
15,32350771,Coverage of Sex Acts by Event-Driven Pre-exposure Prophylaxis: A Sub-Study of the ANRS IPERGAY Trial.,"We assessed the coverage of sex acts by event-driven pre-exposure prophylaxis (ED-PrEP) over a 2-month period in 54 participants in the open label phase of the ANRS Ipergay trial. Participants received an electronic monitoring system device to record bottle openings. Self-questionnaires collected daily information on PrEP intake and sexual behavior. Intake was also estimated through returned pill counts. Full coverage of sex acts was defined as at least one pill taken both within 24 h before and within 48 h following sex. There was a strong correlation (r = - 0.92) between the number of bottle openings and returned pill counts. During the study, 42 participants (78%) practiced ED-PrEP and 12 (22%) daily PrEP with bottle openings at least 5 days/week whatever their sexual activity. Out of the 154 reported receptive anal sex acts, 81% were condomless: among them, PrEP coverage was hight: 97% among those practicing daily PrEP and 82% among those using ED-PrEP.",2020,"Out of the 154 reported receptive anal sex acts, 81% were condomless: among them, PrEP coverage was hight: 97% among those practicing daily PrEP and 82% among those using ED-PrEP.","['42 participants (78%) practiced ED-PrEP and 12 (22%) daily', '54 participants in the open label phase of the ANRS Ipergay trial']","['PrEP', 'Event-Driven Pre-exposure Prophylaxis', 'electronic monitoring system device to record bottle openings']","['Full coverage of sex acts', 'PrEP intake and sexual behavior']","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0336646', 'cui_str': 'Electronic monitor'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",42.0,0.0389101,"Out of the 154 reported receptive anal sex acts, 81% were condomless: among them, PrEP coverage was hight: 97% among those practicing daily PrEP and 82% among those using ED-PrEP.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bauer', 'Affiliation': 'Inserm SC10, Villejuif, France. rebecca.bauer@inserm.fr.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Netzer', 'Affiliation': 'Inserm SC10, Villejuif, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Pintado', 'Affiliation': 'Hôpital Saint-Louis, Maladies infectieuses, Paris, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Capitant', 'Affiliation': 'Inserm SC10, Villejuif, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cua', 'Affiliation': ""Hôpital de l'Archet, Maladies infectieuses, Nice, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Etien', 'Affiliation': 'ANRS, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Fonsart', 'Affiliation': 'Biochimie Et Biologie Moléculaire, Hôpital Lariboisière, Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Pialoux', 'Affiliation': 'Hôpital Tenon, Maladies infectieuses, Paris, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Chidiac', 'Affiliation': 'Hôpital de la Croix Rousse, Lyon, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Etienne', 'Affiliation': 'Centre Hospitalier de Grasse, Grasse, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Doré', 'Affiliation': 'ANRS, Paris, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'Inserm SC10, Université Paris Sud, Université Paris Saclay, Villejuif, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Hôpital Saint-Louis, Maladies infectieuses, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-020-02890-6']
16,32365601,Preschoolers Build Fundamental Motor Skills Critical to an Active Lifestyle: The All 4 Kids © Intervention Study.,"This pragmatic, real world study examined the effects of the All 4 Kids © intervention on preschoolers' mastery of movement skills and determined whether the instruction had greater impact than natural development. Methods included a quasi-experimental intervention-comparison subsample of 379 children (COMPARISON) and a pretest-posttest design with convenience scale-up sampling of 2817 preschoolers (SCALE-UP). Children receiving education and dance instruction 3 times/week for 8 weeks were assessed using the Preschool Movement Assessment to evaluate skills pre and post intervention. Using repeated measures ANOVA, McNemar and Wilcoxon signed ranks tests, preschooler's participation in the intervention resulted in greater improvement in 12 movement skills ( F = 83.451, df = 1, p < 0.001, η p 2 = 0.555), balance ( p = 0.028), hopping ( t = -3.545, df = 112, p = 0.001) and crossing the midline ( p < 0.001) than natural development (COMPARISON). In the SCALE-UP study, children significantly improved in all measures based on post-intervention scores. Significant differences were observed between Hispanic and non-Hispanic children for the 12-skills ( b = -0.758, se = 0.161, p < 0.001) using hierarchical linear models; boys' and girls' scores were not differentially impacted by the intervention. Therefore, implementation of interventions focused on fundamental movement skill development have the potential to remediate secular motor skill decline in young children.",2020,"Significant differences were observed between Hispanic and non-Hispanic children for the 12-skills ( b = -0.758, se = 0.161, p < 0.001) using hierarchical linear models; boys' and girls' scores were not differentially impacted by the intervention.","['Preschoolers Build Fundamental Motor Skills Critical to an Active Lifestyle', 'young children', '379 children (COMPARISON) and a pretest-posttest design with convenience scale-up sampling of 2817 preschoolers (SCALE-UP']",[],['12 movement skills'],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]",[],"[{'cui': 'C0026649', 'cui_str': 'Movement'}]",379.0,0.0172845,"Significant differences were observed between Hispanic and non-Hispanic children for the 12-skills ( b = -0.758, se = 0.161, p < 0.001) using hierarchical linear models; boys' and girls' scores were not differentially impacted by the intervention.","[{'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Lindsay', 'Affiliation': 'Extension, College of Agriculture, Biotechnology & Natural Resources (CABNR), University of Nevada, Reno, NV 89123, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Starrett', 'Affiliation': 'Department of Educational Studies, College of Education, University of South Carolina, Columbia, SC 29208, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Brian', 'Affiliation': 'Department of Physical Education, College of Education, University of South Carolina, Columbia, SC 29208, USA.'}, {'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Byington', 'Affiliation': 'Extension, College of Agriculture, Biotechnology & Natural Resources (CABNR), University of Nevada, Reno, NV 89123, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lucas', 'Affiliation': 'Department of Family Medicine, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Sigman-Grant', 'Affiliation': 'Extension, College of Agriculture, Biotechnology & Natural Resources (CABNR), University of Nevada, Reno, NV 89123, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17093098']
17,32358640,"Probiotic Administration Increases Amino Acid Absorption from Plant Protein: a Placebo-Controlled, Randomized, Double-Blind, Multicenter, Crossover Study.","The fate of dietary protein in the gut is determined by microbial and host digestion and utilization. Fermentation of proteins generates bioactive molecules that have wide-ranging health effects on the host. The type of protein can affect amino acid absorption, with animal proteins generally being more efficiently absorbed compared with plant proteins. In contrast to animal proteins, most plant proteins, such as pea protein, are incomplete proteins. Pea protein is low in methionine and contains lower amounts of branched-chain amino acids (BCAAs), which play a crucial role in muscle health. We hypothesized that probiotic supplementation results in favorable changes in the gut microbiota, aiding the absorption of amino acids from plant proteins by the host. Fifteen physically active men (24.2 ± 5.0 years; 85.3 ± 12.9 kg; 178.0 ± 7.6 cm; 16.7 ± 5.8% body fat) co-ingested 20 g of pea protein with either AminoAlta™, a multi-strain probiotic (5 billion CFU L. paracasei LP-DG® (CNCM I-1572) plus 5 billion CFU L. paracasei LPC-S01 (DSM 26760), SOFAR S.p.A., Italy) or a placebo for 2 weeks in a randomized, double-blind, crossover design, separated by a 4-week washout period. Blood samples were taken at baseline and at 30-, 60-, 120-, and 180-min post-ingestion and analyzed for amino acid content. Probiotic administration significantly increased methionine, histidine, valine, leucine, isoleucine, tyrosine, total BCAA, and total EAA maximum concentrations (Cmax) and AUC without significantly changing the time to reach maximum concentrations. Probiotic supplementation can be an important nutritional strategy to improve post-prandial changes in blood amino acids and to overcome compositional shortcomings of plant proteins. ClinicalTrials.gov Identifier: ISRCTN38903788.",2020,"Probiotic administration significantly increased methionine, histidine, valine, leucine, isoleucine, tyrosine, total BCAA, and total EAA maximum concentrations (Cmax) and AUC without significantly changing the time to reach maximum concentrations.","['Fifteen physically active men (24.2\u2009±\u20095.0\xa0years; 85.3\u2009±\u200912.9\xa0kg; 178.0\u2009±\u20097.6\xa0cm; 16.7\u2009±\u20095.8% body fat) co-ingested 20\xa0g of pea protein with either AminoAlta™, a']","['Probiotic', 'Placebo', 'Probiotic supplementation', 'probiotic supplementation', 'multi-strain probiotic (5 billion CFU L. paracasei LP-DG® (CNCM I-1572) plus 5 billion CFU L. paracasei LPC-S01', 'placebo']","['methionine, histidine, valine, leucine, isoleucine, tyrosine, total BCAA, and total EAA maximum concentrations (Cmax) and AUC']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C3535674', 'cui_str': 'Pea Proteins'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0019602', 'cui_str': 'Histidine'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0022192', 'cui_str': 'Isoleucine'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0243046', 'cui_str': 'Excitatory Amino Acid'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",15.0,0.179951,"Probiotic administration significantly increased methionine, histidine, valine, leucine, isoleucine, tyrosine, total BCAA, and total EAA maximum concentrations (Cmax) and AUC without significantly changing the time to reach maximum concentrations.","[{'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Jäger', 'Affiliation': 'Increnovo, Milwaukee, WI, USA. ralf.jaeger@increnovo.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zaragoza', 'Affiliation': 'Human Performance Laboratory, School of Exercise & Sport Science, University of Mary Hardin-Baylor, Belton, TX, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Purpura', 'Affiliation': 'Increnovo, Milwaukee, WI, USA.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Iametti', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Marengo', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Grant M', 'Initials': 'GM', 'LastName': 'Tinsley', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Anzalone', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Oliver', 'Affiliation': 'Army West Point Athletics Association, West Point, NY, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Fiore', 'Affiliation': 'Sofar S.p.A., Trezzano Rosa, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Biffi', 'Affiliation': 'Sofar S.p.A., Trezzano Rosa, Italy.'}, {'ForeName': 'Stacie', 'Initials': 'S', 'LastName': 'Urbina', 'Affiliation': 'Human Performance Laboratory, School of Exercise & Sport Science, University of Mary Hardin-Baylor, Belton, TX, USA.'}, {'ForeName': 'Lem', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'Human Performance Laboratory, School of Exercise & Sport Science, University of Mary Hardin-Baylor, Belton, TX, USA.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-020-09656-5']
18,32361414,Neural correlates of NOS1 ex1f-VNTR allelic variation in panic disorder and agoraphobia during fear conditioning and extinction in fMRI.,"Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior in animals. In humans, the short (S) allele of a functional promotor polymorphism of NOS1 (NOS1 ex1f-VNTR) has been shown to be associated with higher anxiety and altered fear conditioning in healthy subjects in the amygdala and hippocampus (AMY/HIPP). Here, we explore the role of NOS1 ex1f-VNTR as a pathophysiological correlate of panic disorder and agoraphobia (PD/AG). In a sub-sample of a multicenter cognitive behavioral therapy (CBT) randomized controlled trial in patients with PD/AG (n = 48: S/S-genotype n=15, S/L-genotype n=21, L/L-genotype n=12) and healthy control subjects, HS (n = 34: S/S-genotype n=7, S/L-genotype n=17, L/L-genotype=10), a differential fear conditioning and extinction fMRI-paradigm was used to investigate how NOS1 ex1f-VNTR genotypes are associated with differential neural activation in AMY/HIPP. Prior to CBT, L/L-allele carriers showed higher activation than S/S-allele carriers in AMY/HIPP. A genotype × diagnosis interaction revealed that the S-allele in HS was associated with a pronounced deactivation in AMY/HIPP, while patients showed contrary effects. The interaction of genotype × stimulus type (CS+, conditioned stimulus associated with an aversive stimulus vs. CS-, unassociated) showed effects on differential learning in AMY/HIPP. All effects were predominately found during extinction. Genotype associated effects in patients were not altered after CBT. Low statistical power due to small sample size in each subgroup is a major limitation. However, our findings provide first preliminary evidence for dysfunctional neural fear conditioning/extinction associated with NOS1 ex1f-VNTR genotype in the context of PD/AG, shedding new light on the complex interaction between genetic risk, current psychopathology and treatment-related effects.",2020,Genotype associated effects in patients were not altered after CBT.,"['n\xa0=\xa048', 'healthy subjects', 'animals', 'patients with PD/AG', 'panic disorder and agoraphobia during fear conditioning and extinction in fMRI']",['cognitive behavioral therapy (CBT'],['Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0669368', 'cui_str': 'Nitric Oxide Synthase, Type I'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0249077,Genotype associated effects in patients were not altered after CBT.,"[{'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Ridderbusch', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany. Electronic address: isabelle.ridderbusch@med.uni-marburg.de.'}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Herterich', 'Affiliation': 'Clinical Chemistry and Laboratory Medicine, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Pfleiderer', 'Affiliation': 'Medical Faculty, University of Münster and Department Clinical Radiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Arolt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität (LMU), München, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Straube', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102268']
19,32365607,Effectiveness of a Teacher Training Program for Students with Symptoms of Developmental Disorders: Data from a Correspondence High School in Japan.,"In the present study, a teacher training program based on behavioral therapy was conducted for high school correspondence course teachers of adolescents aged between 15 and 18 years who showed developmental difficulties. Participating teachers were assigned to either an immediate treatment (IT; n = 13) or delayed treatment control (DTC; n = 17) group to evaluate the effectiveness of the program, which comprised five 90-min sessions with small groups of three to six participants and was conducted over three months. The results showed significant improvement in students' behaviors and social responsiveness and in teachers' confidence among those in the IT group; however, those in the DTC group did not show any such improvement. We discuss the program's feasibility in terms of developing support resources for teachers in Japanese high schools.",2020,"The results showed significant improvement in students' behaviors and social responsiveness and in teachers' confidence among those in the IT group; however, those in the DTC group did not show any such improvement.","['Students with Symptoms of Developmental Disorders', 'teachers in Japanese high schools', 'high school correspondence course teachers of adolescents aged between 15 and 18 years who showed developmental difficulties']","['teacher training program based on behavioral therapy', 'Teacher Training Program', 'immediate treatment (IT; n = 13) or delayed treatment control (DTC']","[""students' behaviors and social responsiveness and in teachers' confidence""]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0010104', 'cui_str': 'Correspondence Courses'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]","[{'cui': 'C4082803', 'cui_str': 'Teacher Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3693346', 'cui_str': 'Treatment Delay'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012194', 'cui_str': 'Dithiocarb'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0115432,"The results showed significant improvement in students' behaviors and social responsiveness and in teachers' confidence among those in the IT group; however, those in the DTC group did not show any such improvement.","[{'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Ishii', 'Affiliation': 'United Graduate School of Child Development, Osaka University, Osaka 565-0871, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Okuno', 'Affiliation': 'United Graduate School of Child Development, Osaka University, Osaka 565-0871, Japan.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Nakaoka', 'Affiliation': 'Clark Memorial International High School, Hyogo 669-1512, Japan.'}, {'ForeName': 'Hidemi', 'Initials': 'H', 'LastName': 'Iwasaka', 'Affiliation': 'Developmental Center for Child and Adult, Shigisan Hospital, Nara 636-0815, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Taniike', 'Affiliation': 'United Graduate School of Child Development, Osaka University, Osaka 565-0871, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph17093100']
20,32351173,Change in dysfunctional attitudes and attachment in interpersonal psychotherapy for depressed adolescents.,"This study examined changes in depressed adolescents' reports of dysfunctional attitudes while receiving interpersonal psychotherapy (IPT-A) and the relationship between the change in dysfunctional attitudes and change in attachment anxiety and avoidance with IPT-A. Forty adolescents (age 12-17) participated in a 16-week randomized clinical trial of 4 adaptive treatment strategies that began with IPT-A and augmented treatment for insufficient responders by adding additional IPT-A sessions or the antidepressant medication, fluoxetine. Measures of attachment anxiety and avoidance (Experience in Close Relationships Scale-Revised [ECR-R]), dysfunctional attitudes (Dysfunctional Attitudes Scale [DAS]), and depression (Children's Depression Rating Scale-Revised [CDRS-R]) were administered at baseline and weeks 4, 8, 12, and 16. Adolescents demonstrated a significant decrease in dysfunctional attitudes (DAS) over the course of treatment. Reductions in dysfunctional attitudes (DAS) were also significantly associated with reductions in attachment anxiety and avoidance (ECR-R), controlling for depression (CDRS-R). Our results suggest that change in adolescents' attachment anxiety and avoidance may be an important mechanism of change in adolescents' dysfunctional thinking patterns.",2020,"Reductions in dysfunctional attitudes (DAS) were also significantly associated with reductions in attachment anxiety and avoidance (ECR-R), controlling for depression (CDRS-R).","['depressed adolescents', 'with IPT-A. Forty adolescents (age 12-17']","['IPT-A and augmented treatment for insufficient responders by adding additional IPT-A sessions or the antidepressant medication, fluoxetine', 'interpersonal psychotherapy (IPT-A']","[""attachment anxiety and avoidance (Experience in Close Relationships Scale-Revised [ECR-R]), dysfunctional attitudes (Dysfunctional Attitudes Scale [DAS]), and depression (Children's Depression Rating Scale-Revised [CDRS-R"", 'attachment anxiety and avoidance (ECR-R), controlling for depression (CDRS-R', 'dysfunctional attitudes (DAS', 'attachment anxiety and avoidance']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",4.0,0.0206748,"Reductions in dysfunctional attitudes (DAS) were also significantly associated with reductions in attachment anxiety and avoidance (ECR-R), controlling for depression (CDRS-R).","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Psychology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Arend', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mufson', 'Affiliation': 'Columbia University College of Physicians & Surgeons and New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Gunlicks-Stoessel', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1756513']
21,32357889,The effect of antimicrobial activity of Teucrium Polium on Oral Streptococcus Mutans: a randomized cross-over clinical trial study.,"BACKGROUND
The purpose of this study is to determine the effect of a mouthwash containing Teucriumpolium herb on Streptococcus mutans in mouth.
METHODS
This study was a randomized, crossover, double-blind clinical trial, where we selected 22 volunteers (dental students) randomly and we divided them into two groups. The study had two phases. In each phase, one group acted as the intervention group, while the other one was the control group. Both the intervention and control groups were given the mouthwash with and without Teucriumpolium, respectively. S. mutans of saliva were measured before and after each phase to compare the effects of the mouthwashes. A three-week washout period was considered between the two phases. An independent two-sample t-test was utilized to compare the mean of S. mutans colonies. Additionally, we used a standard AB/BA crossover model to find the results of the treatment and the impact of carryover on the residual's biological effects. The significance level was considered 0.05 in this experiment.
RESULTS
There is no significant difference observed between the two groups in the number of S. mutans before using the mouthwashes. When the mouthwash containing Teucriumpolium was used, there was a significant decrease in the number of S. mutans colonies in both phases' extract (P = 0.002).
CONCLUSION
The results of this study indicate the mouthwash containing aqueous extract of Teucrium polium can majorly reduce the colonization of S. mutans in human saliva.
TRIAL REGISTRATION
Ethical issues approved by the Ethics Committee of the Rafsanjan University of Medical Sciences with the approval number of 937/9/31, IRCT code Number of IRCT2013121815842N1 and it was approved on 06/16/2014. The study was conducted in the period of September to November 2014.",2020,There is no significant difference observed between the two groups in the number of S. mutans before using the mouthwashes.,"['Streptococcus mutans in mouth', '22 volunteers (dental students', 'Oral Streptococcus Mutans']","['Teucrium Polium', 'mouthwash containing Teucriumpolium herb']","['number of S. mutans', 'number of S. mutans colonies']","[{'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}]","[{'cui': 'C3415126', 'cui_str': 'Teucrium polium'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0019240', 'cui_str': 'Herb'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439158', 'cui_str': 'colonies'}]",22.0,0.0545633,There is no significant difference observed between the two groups in the number of S. mutans before using the mouthwashes.,"[{'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Khoramian Tusi', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Alborz University of Medical Sciences, Alborz, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Jafari', 'Affiliation': 'Research Center for Caries Prevention, Dental Research Institute, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran. ajafari@tums.ac.ir.'}, {'ForeName': 'Seyed Mahmoud Amin', 'Initials': 'SMA', 'LastName': 'Marashi', 'Affiliation': 'Department of Microbiology, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Salomeh', 'Initials': 'S', 'LastName': 'Faramarzi Niknam', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Alborz University of Medical Sciences, Alborz, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Farid', 'Affiliation': 'Department of Community Medicine, School of Medicine, Alborz University of Medical Sciences, Alborz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Ansari', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Kerman University of Medical Sciences, Kerman, Iran.'}]",BMC oral health,['10.1186/s12903-020-01116-4']
22,32365355,L-Thyroxine Therapy for Older Adults With Subclinical Hypothyroidism and Hypothyroid Symptoms: Secondary Analysis of a Randomized Trial.,"BACKGROUND
L-thyroxine does not improve hypothyroid symptoms among adults with subclinical hypothyroidism (SCH). However, those with greater symptom burden before treatment may still benefit.
OBJECTIVE
To determine whether L-thyroxine improves hypothyroid symptoms and tiredness among older adults with SCH and greater symptom burden.
DESIGN
Secondary analysis of the randomized, placebo-controlled trial TRUST (Thyroid Hormone Replacement for Untreated Older Adults with Subclinical Hypothyroidism Trial). (ClinicalTrials.gov: NCT01660126).
SETTING
Switzerland, Ireland, the Netherlands, and Scotland.
PARTICIPANTS
638 persons aged 65 years or older with persistent SCH (thyroid-stimulating hormone level of 4.60 to 19.9 mIU/L for >3 months and normal free thyroxine level) and complete outcome data.
INTERVENTION
L-thyroxine or matching placebo with mock dose titration.
MEASUREMENTS
1-year change in Hypothyroid Symptoms and Tiredness scores (range, 0 to 100; higher scores indicate more symptoms) on the Thyroid-Related Quality-of-Life Patient-Reported Outcome Questionnaire among participants with high symptom burden (baseline Hypothyroid Symptoms score >30 or Tiredness score >40) versus lower symptom burden.
RESULTS
132 participants had Hypothyroid Symptoms scores greater than 30, and 133 had Tiredness scores greater than 40. Among the group with high symptom burden, the Hypothyroid Symptoms score improved similarly between those receiving L-thyroxine (mean within-group change, -12.3 [95% CI, -16.6 to -8.0]) and those receiving placebo (mean within-group change, -10.4 [CI, -15.3 to -5.4]) at 1 year; the adjusted between-group difference was -2.0 (CI, -5.5 to 1.5; P = 0.27). Improvements in Tiredness scores were also similar between those receiving L-thyroxine (mean within-group change, -8.9 [CI, -14.5 to -3.3]) and those receiving placebo (mean within-group change, -10.9 [CI, -16.0 to -5.8]); the adjusted between-group difference was 0.0 (CI, -4.1 to 4.0; P = 0.99). There was no evidence that baseline Hypothyroid Symptoms score or Tiredness score modified the effects of L-thyroxine versus placebo ( P for interaction = 0.20 and 0.82, respectively).
LIMITATION
Post hoc analysis, small sample size, and examination of only patients with 1-year outcome data.
CONCLUSION
In older adults with SCH and high symptom burden at baseline, L-thyroxine did not improve hypothyroid symptoms or tiredness compared with placebo.
PRIMARY FUNDING SOURCE
European Union FP7.",2020,"Improvements in Tiredness scores were also similar between those receiving L-thyroxine (mean within-group change, -8.9 [CI, -14.5 to -3.3]) and those receiving placebo (mean within-group change, -10.9 [CI, -16.0 to -5.8]); the adjusted between-group difference was 0.0 (CI, -4.1 to 4.0; P = 0.99).","['Untreated Older Adults with Subclinical Hypothyroidism Trial', '132 participants had', 'adults with subclinical hypothyroidism (SCH', 'Older Adults With Subclinical Hypothyroidism and Hypothyroid Symptoms', 'Participants\n\n\n638 persons aged 65 years or older with persistent SCH (thyroid-stimulating hormone level of 4.60 to 19.9 mIU/L for >3 months and normal free thyroxine level) and complete outcome data', 'older adults with SCH and greater symptom burden']","['Intervention\n\n\nL-thyroxine or matching placebo', 'L-thyroxine', 'placebo-controlled trial TRUST (Thyroid Hormone Replacement', 'L-Thyroxine Therapy', '\n\n\nL-thyroxine', 'placebo']","['Hypothyroid Symptoms score', 'hypothyroid symptoms and tiredness', 'Hypothyroid Symptoms scores', 'Hypothyroid Symptoms and Tiredness scores', 'hypothyroid symptoms or tiredness', 'baseline Hypothyroid Symptoms score or Tiredness score', 'Tiredness scores', 'hypothyroid symptoms']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C0439462', 'cui_str': 'mIU/L'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0861033', 'cui_str': 'Thyroxine free normal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205393', 'cui_str': 'Most'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",638.0,0.652293,"Improvements in Tiredness scores were also similar between those receiving L-thyroxine (mean within-group change, -8.9 [CI, -14.5 to -3.3]) and those receiving placebo (mean within-group change, -10.9 [CI, -16.0 to -5.8]); the adjusted between-group difference was 0.0 (CI, -4.1 to 4.0; P = 0.99).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'de Montmollin', 'Affiliation': 'Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Feller', 'Affiliation': 'Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).'}, {'ForeName': 'Shanthi', 'Initials': 'S', 'LastName': 'Beglinger', 'Affiliation': 'Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland (A.M., I.F.).'}, {'ForeName': 'Drahomir', 'Initials': 'D', 'LastName': 'Aujesky', 'Affiliation': 'Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.A.).'}, {'ForeName': 'Tinh-Hai', 'Initials': 'TH', 'LastName': 'Collet', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Lausanne University Hospital, and University of Lausanne, Lausanne, Switzerland (T.C.).'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland (A.M., I.F.).'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands (J.G., R.K.P.).'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kearney', 'Affiliation': 'School of Public Health, University College Cork, Cork, Ireland (P.M.K.).'}, {'ForeName': 'Vera J C', 'Initials': 'VJC', 'LastName': 'McCarthy', 'Affiliation': 'School of Nursing and Midwifery, University College Cork, Cork, Ireland (V.J.M.).'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Mooijaart', 'Affiliation': 'Institute for Evidence-based Medicine in Old Age, Leiden University Medical Center, Leiden, the Netherlands (S.M.).'}, {'ForeName': 'Rosalinde K E', 'Initials': 'RKE', 'LastName': 'Poortvliet', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands (J.G., R.K.P.).'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland (T.Q., D.J.S.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stott', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland (T.Q., D.J.S.).'}, {'ForeName': 'Torquil', 'Initials': 'T', 'LastName': 'Watt', 'Affiliation': 'Copenhagen University Hospital Herlev, Herlev, Denmark, and University of Copenhagen, Copenhagen, Denmark (T.W., R.W.).'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Westendorp', 'Affiliation': 'Copenhagen University Hospital Herlev, Herlev, Denmark, and University of Copenhagen, Copenhagen, Denmark (T.W., R.W.).'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Bauer', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark; and University of California, San Francisco, San Francisco, California (D.C.B.).'}]",Annals of internal medicine,['10.7326/M19-3193']
23,32365359,"Rifabutin-Based Triple Therapy (RHB-105) for Helicobacter pylori Eradication: A Double-Blind, Randomized, Controlled Trial.","BACKGROUND
Although consensus supports eradication of Helicobacter pylori infections, antimicrobial resistance has substantially reduced eradication rates with most current therapies.
OBJECTIVE
To assess the effectiveness of a novel rifabutin-based therapy (RHB-105) for H pylori eradication.
DESIGN
Phase 3, double-blind trial (ERADICATE Hp2). (ClinicalTrials.gov: NCT03198507).
SETTING
55 clinical research sites in the United States.
PARTICIPANTS
455 treatment-naive adults with epigastric discomfort and confirmed H pylori infection.
INTERVENTION
RHB-105 (amoxicillin, 3 g; omeprazole, 120 mg; and rifabutin, 150 mg) versus active comparator (amoxicillin, 3 g, and omeprazole, 120 mg), given as 4 capsules every 8 hours for 14 days.
MEASUREMENTS
Between-group difference for H pylori eradication rate, demonstrated by 13 C urea breath test 4 weeks after treatment, analyzed by using the χ 2 test.
RESULTS
In the intention-to-treat population, the eradication rate was higher with RHB-105 than with the active comparator (228 vs. 227 patients, respectively; 83.8% [95% CI, 78.4% to 88.0%] vs. 57.7% [95% CI, 51.2% to 64.0%]; P < 0.001). Eradication rates were unaffected by resistance to clarithromycin or metronidazole. No rifabutin resistance was detected. The most commonly reported adverse events (incidence ≥5%) were diarrhea (10.1% with RHB-105 vs. 7.9% with active comparator), headache (7.5% vs. 7.0%), and nausea (4.8% vs. 5.3%).
LIMITATION
Persons of Asian descent were excluded because of their higher prevalence of poor cytochrome P450 2C19 metabolizers.
CONCLUSION
These findings suggest potential for RHB-105 as first-line empirical H pylori therapy, addressing an unmet need in the current environment of increasing antibiotic resistance.
PRIMARY FUNDING SOURCE
RedHill Biopharma Ltd.",2020,Eradication rates were unaffected by resistance to clarithromycin or metronidazole.,"['Participants\n\n\n455 treatment-naive adults with epigastric discomfort and confirmed H pylori infection', 'Helicobacter pylori Eradication', 'Limitation\n\n\nPersons of Asian descent']","['novel rifabutin-based therapy (RHB-105', 'RHB-105 (amoxicillin, 3 g; omeprazole, 120 mg; and rifabutin, 150 mg) versus active comparator (amoxicillin, 3 g, and omeprazole', 'Rifabutin-Based Triple Therapy (RHB-105', 'metronidazole', 'clarithromycin']","['headache', 'diarrhea', 'rifabutin resistance', 'eradication rate', 'Eradication rates', 'adverse events', 'nausea', 'eradication rates', 'H pylori eradication rate']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0232570', 'cui_str': 'Epigastric fullness'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205386', 'cui_str': 'Descending'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",455.0,0.422929,Eradication rates were unaffected by resistance to clarithromycin or metronidazole.,"[{'ForeName': 'David Y', 'Initials': 'DY', 'LastName': 'Graham', 'Affiliation': 'Baylor College of Medicine, Houston, Texas (D.Y.G., K.G.H.).'}, {'ForeName': 'Yamil', 'Initials': 'Y', 'LastName': 'Canaan', 'Affiliation': 'Jesscan Medical Research, Miami, Florida (Y.C.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Maher', 'Affiliation': 'BI Research Center, Houston, Texas (J.M.).'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Wiener', 'Affiliation': 'GW Research, Inc., Chula Vista, California (G.W.).'}, {'ForeName': 'Kristina G', 'Initials': 'KG', 'LastName': 'Hulten', 'Affiliation': 'Baylor College of Medicine, Houston, Texas (D.Y.G., K.G.H.).'}, {'ForeName': 'Ira N', 'Initials': 'IN', 'LastName': 'Kalfus', 'Affiliation': 'Independent Consultant to Pharmaceutical companies, New York, New York (I.N.K.).'}]",Annals of internal medicine,['10.7326/M19-3734']
24,32353536,Agreement of Spectral-Domain OCT with Fluorescein Leakage in Neovascular Age-Related Macular Degeneration: Post Hoc Analysis of the HARBOR Study.,"PURPOSE
To evaluate the agreement between detection of activity of choroidal neovascularization (CNV) in neovascular age-related macular degeneration (AMD) by fundus fluorescein angiography (FFA) and spectral-domain (SD) OCT in the HARBOR study. Most retina specialists rely on OCT to guide treatment decisions in neovascular AMD. However, OCT may not always detect exudative activity. Traditionally, FFA was frequently performed in clinical practice, but its use has diminished due to reliance on OCT.
DESIGN
Retrospective post hoc analysis of prospective clinical trial (HARBOR; ClinicalTrials.gov identifier, NCT00891735).
PARTICIPANTS
Patients with neovascular AMD in the HARBOR Trial.
METHODS
Baseline to month 24 data from all randomized study eyes in HARBOR with both FFA and SD OCT data were analyzed for (1) evidence of CNV activity on SD OCT (presence of subretinal fluid, intraretinal fluid, and/or cystoid spaces); (2) evidence of CNV activity on FFA identified by the presence of leakage, and (3) cross-tabulation of CNV activity identified by FFA and SD OCT by office visit.
MAIN OUTCOME MEASURES
The percent agreement between FFA and SD OCT in detecting CNV activity and sensitivity and specificity of SD OCT to detect fluorescein leakage in neovascular AMD using FFA as the reference standard.
RESULTS
At baseline, 1094 patients (99.9%) had agreement between SD OCT and FFA in detecting CNV activity. By month 24, of the 779 total active cases, the agreement was only 36% (277 cases). By month 24, most cases (n = 452 [58%]) had evidence of CNV activity on SD OCT only, whereas 6% of cases (n = 50) had CNV activity identified by FFA only. At screening and months 3, 6, 12, and 24, 92% to 100% of cases identified by FFA only were occult CNV lesions. Using FFA as the reference standard, the sensitivity and specificity of SD OCT in detecting CNV activity was 91% (95% confidence interval [CI], 84%-99%) and 13% (95% CI, 4%-22%).
CONCLUSIONS
Spectral-domain OCT alone can be relied upon for detecting CNV activity while monitoring eyes with neovascular AMD. However, FFA may still be of value in those with occult lesions that appear quiescent on SD OCT, as this type of lesion may show leakage on FFA.",2020,"By month 24 most cases (n= 452, 58%) had evidence of CNV activity on SD-OCT only, while 6% of cases (n=50) had CNV activity identified by FFA only.","['neovascular age-related macular degeneration (AMD) by fundus', 'Neovascular Age-related Macular Degeneration', ' Baseline to Month 24 data from all randomized study eyes in HARBOR with both FFA and SD-OCT data']","['Spectral Domain Optical Coherence Tomography with Fluorescein Leakage', 'FFA', 'fluorescein angiography (FFA) and spectral domain (SD)- optical coherence tomography (OCT', 'choroidal neovascularization (CNV', 'OCT']","['CNV activity', 'occult CNV lesions', 'CNV activity on SD-OCT', 'sensitivity and specificity of SD-OCT in detecting CNV activity']","[{'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0430878', 'cui_str': 'Posterior segment fluorescein angiography'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]","[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0430878', 'cui_str': 'Posterior segment fluorescein angiography'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}]","[{'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0442726', 'cui_str': 'Detected'}]",,0.0420517,"By month 24 most cases (n= 452, 58%) had evidence of CNV activity on SD-OCT only, while 6% of cases (n=50) had CNV activity identified by FFA only.","[{'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California. Electronic address: rnkhurana@gmail.com.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hill', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Avanti', 'Initials': 'A', 'LastName': 'Ghanekar', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Shamika', 'Initials': 'S', 'LastName': 'Gune', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.04.016']
25,32353544,Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations.,"Opioid use disorder (OUD) in pregnant women has increased significantly in recent years. Maintaining these women on sublingual (SL) buprenorphine (BUP) is an evidence-based practice but BUP-SL is associated with several disadvantages that an extended-release (XR) BUP formulation could eliminate. The National Drug Abuse Treatment Clinical Trials Network (CTN) is conducting an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial, Medication treatment for Opioid-dependent expectant Mothers (MOMs), to compare mother and infant outcomes of pregnant women with OUD treated with BUP-XR, relative to BUP-SL. A second aim is to determine the relative economic value of utilizing BUP-XR. Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization. Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum. Participants will be invited to participate in two sub-studies to evaluate the: 1) mechanisms by which BUP-XR may improve mother and infant outcomes; and 2) effects of prenatal exposure to BUP-XR versus BUP-SL on infant neurodevelopment. This paper describes the key design decisions for the main trial made during protocol development. This Investigational New Drug (IND) trial uniquely uses pragmatic features where feasible in order to maximize external validity, hence increasing the potential to inform clinical practice guidelines and address multiple knowledge gaps for treatment of this patient population.",2020,"Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization.","['expectant mothers (MOMs', 'Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30\u202fweeks, recruited from 12 sites', 'pregnant women with OUD treated with BUP-XR, relative to BUP-SL', 'pregnant women']","['sublingual (SL) buprenorphine (BUP', 'buprenorphine formulations', 'prenatal exposure to BUP-XR versus BUP-SL']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],300.0,0.0591114,"Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Lofwall', 'Affiliation': 'Departments of Behavioral Science and Psychiatry, University of Kentucky College of Medicine, Center on Drug and Alcohol Research, 845 Angliana Avenue, Lexington, KY 40508, USA.'}, {'ForeName': 'Hendrée E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina Chapel Hill, 410 North Greensboro St., Carrboro, NC 27510, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Davida M', 'Initials': 'DM', 'LastName': 'Schiff', 'Affiliation': 'Division of General Academic Pediatrics, MassGeneral Hospital for Children, 125 Nashua St Suite 860, Boston, MA 02114, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wexelblatt', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Merhar', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medical College, 425 East 61st Street Suite 301, New York, NY 10065, USA.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': ""Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA; Division of Alcohol, Drug and Addictions and the Division of Women's Mental Health, McLean Hospital, 115 Mill Street, Belmont, MA 02478, USA.""}, {'ForeName': 'Mishka', 'Initials': 'M', 'LastName': 'Terplan', 'Affiliation': 'Friends Research Institute,1040 Park Ave Suite 103, Baltimore, MD 21201, USA.'}, {'ForeName': 'Elisha M', 'Initials': 'EM', 'LastName': 'Wachman', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, 801 Albany Street, Boston, MA 02119, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Abigail G', 'Initials': 'AG', 'LastName': 'Matthews', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Medical University of South Carolina, 67 President St., MSC 861, Charleston, SC 29425, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverstein', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston University School of Medicine, 88 East Newton Street, Boston, MA 02118, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Rosa', 'Affiliation': 'Center for the Clinical Trials Network, National Institute on Drug Abuse, 6001 Executive Blvd, Bethesda, MD 20892, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106014']
26,32356586,Efficacy of oral methotrexate (MTX) monotherapy vs oral MTX plus narrowband ultraviolet light B phototherapy in palmoplantar psoriasis.,"Palmoplantar psoriasis (PPP) is a chronic, inflammatory dermatosis of the palms and/or soles with significant morbidity. It is notoriously difficult to treat and unresponsive to traditional topical agents. We aim to compare the effect of oral methotrexate (MTX) monotherapy vs MTX plus narrowband ultraviolet light B (NB-UVB) in the treatment of recalcitrant PPP. This was a comparative clinical trial involving 90 patients of PPP. Eligible patients were randomly assigned to one of the two treatment groups. We aim patients in group A received 10 mg oral MTX weekly, and patients in group B received oral MTX 10 mg weekly and NB-UVB sessions twice weekly for 12 weeks. There was a statistically significant difference in reduction of modified PPP Area Severity Index (m-PPPASI) of patients in MTX plus NB-UVB at week 12. The mean m-PPPASI at week 12 was 3.66 ± 2.11 in MTX plus NB-UVB group and 6.51 ± 2.04 in MTX only group (P < .001). Marked improvement (m-PPPASI 75) was achieved in 20 (44.44%) patients in MTX plus NB-UVB group compared with 6 (13.3%) in MTX monotherapy group (P < .001). Combination of MTX and NB-UVB phototherapy helps to attain a better clinical response (reduction in m-PPPASI score) than MTX monotherapy in the treatment of recalcitrant PPP.",2020,There was a statistically significant difference in reduction of m-PPPASI of patients in MTX plus NB-UVB at weeks 12.,"['90 patients of PPP', 'Eligible patients', 'palmo plantar psoriasis']","['oral Methotrexate (MTX) monotherapy vs Methotrexate plus Narrowband UVB (NB-UVB', 'oral methotrexate monotherapy vs oral methotrexate plus narrow band UV-B phototherapy', 'MTX and NB-UVB phototherapy', 'MTX', '10\xa0mg oral MTX', 'MTX monotherapy', 'oral MTX 10\xa0mg weekly and NB-UVB sessions']","['Palmoplantar psoriasis (PPP', 'mean m-PPPASI', 'reduction of m-PPPASI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031106', 'cui_str': 'Aggressive periodontitis'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C3472306', 'cui_str': 'Narrowband ultraviolet B phototherapy'}, {'cui': 'C1127564', 'cui_str': 'Methotrexate 10 MG'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0031106', 'cui_str': 'Aggressive periodontitis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",90.0,0.0720912,There was a statistically significant difference in reduction of m-PPPASI of patients in MTX plus NB-UVB at weeks 12.,"[{'ForeName': 'Shamim', 'Initials': 'S', 'LastName': 'Ara', 'Affiliation': 'Department of Dermatology and Venereology, Chittagong International Medical College, Chittagong, Bangladesh.'}, {'ForeName': 'Mohammad Rafiqul', 'Initials': 'MR', 'LastName': 'Mowla', 'Affiliation': 'Department of Dermatology and Venereology, Chittagong Medical College, Chittagong, Bangladesh.'}, {'ForeName': 'Mansurul', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': ""Department of Dermatology and Venereology, Cox's Bazar Medical College, Cox's Bazar, Bangladesh.""}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'Department of Pharmacology, Chittagong Medical University, Chittagong, Bangladesh.'}]",Dermatologic therapy,['10.1111/dth.13486']
27,32353218,"Effect of a combined exercise program on physical fitness, lung function, and quality of life in patients with controlled asthma and exercise symptoms: A randomized controlled trial.","BACKGROUND
Asthmatic patients may benefit from exercise training, although the effects of a combined aerobic and resistance training program are still poorly investigated in children and adolescents.
OBJECTIVE
To analyze the effects of a combined exercise training (resistance and aerobic) program on aerobic fitness, lung function, asthma control and quality of life in a group of mild-moderate asthmatic children with exercise symptoms.
METHODS
This was a 12-week randomized controlled trial including children and adolescents diagnosed with mild-moderate asthma and presenting exercise-induced symptoms. The intervention group (IG) performed the exercise training (resistance and aerobic) 3 days/week, for 60 minutes. The control group (CG) followed routine clinical orientations. The main outcomes were cardiorespiratory fitness, muscle strength, lung function, quality of life, asthma control, and functional tests after 3 months of the intervention.
RESULTS
Fifty-three patients (IG = 25 and CG = 28) with a mean age of 11.5 ± 2.6 years were included. No significant differences were found between groups regarding lung function, asthma control, quality of life, and functional tests. Ventilatory equivalent for oxygen consumption at ventilatory threshold (P = .025; η p 2 = 0.083), peak oxygen consumption (P = .008; η p 2 = 0.116) and test duration (P = .014; η p 2 = 0.1) presented greater improvements in the IG. In addition, improvements were observed in leg press (P < .001; η p 2 = 0.36), hamstring curl (P = .001; η p 2 = 0.217), high row (P = .003; η p 2 = .167), low row (P = .009; η p 2 = 0.128) and quadriceps leg extension (P = .015; η p 2 = 0.108) in the IG.
CONCLUSION
Combined exercise training (resistance and aerobic) improved cardiorespiratory fitness and muscle strength in children and adolescents with controlled asthma and exercise symptoms.",2020,"In addition, improvements were observed in leg press (P < .001; η p 2 = 0.36), hamstring curl (P = .001; η p 2 = 0.217), high row (P = .003; η p 2 = .167), low row (P = .009; ","['children and adolescents diagnosed with mild-moderate asthma and presenting exercise-induced symptoms', 'Fifty-three patients (IG\u2009=\u200925 and CG\u2009=\u200928) with a mean age of 11.5\u2009±\u20092.6 years were included', 'patients with controlled asthma and exercise symptoms', 'mild-moderate asthmatic children with exercise symptoms', 'Asthmatic patients', 'children and adolescents with controlled asthma and exercise symptoms', 'children and adolescents']","['exercise training', 'combined aerobic and resistance training program', 'exercise training (resistance and aerobic', 'combined exercise training (resistance and aerobic) program', 'Combined exercise training (resistance and aerobic', 'combined exercise program']","['leg press', 'quadriceps leg extension', 'cardiorespiratory fitness, muscle strength, lung function, quality of life, asthma control, and functional tests', 'hamstring curl', 'lung function, asthma control, quality of life, and functional tests', 'peak oxygen consumption', 'physical fitness, lung function, and quality of life', 'aerobic fitness, lung function, asthma control and quality of life', 'cardiorespiratory fitness and muscle strength']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",,0.0378759,"In addition, improvements were observed in leg press (P < .001; η p 2 = 0.36), hamstring curl (P = .001; η p 2 = 0.217), high row (P = .003; η p 2 = .167), low row (P = .009; ","[{'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Sanz-Santiago', 'Affiliation': 'Pulmonology Unit, Hospital Universitario Infantil Niño Jesús de Madrid, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Diez-Vega', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Santana-Sosa', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Lopez Nuevo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Iturriaga Ramirez', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Fernanda Maria', 'Initials': 'FM', 'LastName': 'Vendrusculo', 'Affiliation': 'Laboratory of Pediatric Physical Activity, Infant Center, PUCRS, Porto Alegre, Brazil.'}, {'ForeName': 'Márcio Vinícius Fagundes', 'Initials': 'MVF', 'LastName': 'Donadio', 'Affiliation': 'Laboratory of Pediatric Physical Activity, Infant Center, PUCRS, Porto Alegre, Brazil.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Villa Asensi', 'Affiliation': 'Pulmonology Unit, Hospital Universitario Infantil Niño Jesús de Madrid, Madrid, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Pérez-Ruiz', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}]",Pediatric pulmonology,['10.1002/ppul.24798']
28,32289380,Clinical outcomes in men of diverse ethnic backgrounds with metastatic castration-resistant prostate cancer.,"BACKGROUND
We have shown previously in multivariable analysis that black men had 19% lower risk of death than white men with metastatic castration-resistant prostate cancer (mCRPC) treated with a docetaxel and prednisone (DP)-based regimen. The primary goal of this analysis was to compare progression-free survival (PFS), biochemical PFS, ≥50% decline in prostate-specific antigen (PSA) from baseline and objective response rate (ORR) in white, black and Asian men with mCRPC treated with a DP-based regimen.
PATIENTS AND METHODS
Individual patient data from 8820 mCRPC men randomized on nine phase III trials to a DP-containing regimen were combined. Race used in the analysis was based on self-report. End points were PFS, biochemical PSA, ≥50% decline in PSA from baseline and ORR. The proportional hazards and the logistic regression models were employed to assess the prognostic importance of race in predicting outcomes adjusting for established prognostic factors.
RESULTS
Of 8820 patients, 7528 (85%) were white, 500 (6%) were black, 424 were Asian (5%) and 368 (4%) had race unspecified. Median PFS were 8.3 [95% confidence interval (CI) 8.2-8.5], 8.2 (95% CI 7.4-8.8) and 8.3 (95% CI 7.6-8.8) months in white, black and Asian men, respectively. Median PSA PFS were 9.9 (95% CI 9.7-10.4), 8.5 (95% CI 8.0-10.3) and 11.1 (95% CI 9.9-12.5) months in white, black and Asian men, respectively.
CONCLUSIONS
We observed no differences in clinical outcomes by race and ethnic groups in men with mCRPC enrolled on these phase III clinical trials with DP.",2020,"Median PSA PFS were 9.7 months (95% CI 9.4-10), 8.5 months (95% CI 7.6-10) and 10.0 (95% CI 9.5-11.8) in white, black and Asian men, respectively.
","['white, black and Asian men with mCRPC treated with a DP-based regimen', 'men with mCRPC enrolled on these phase III clinical trials with DP', 'black men had 19% lower risk of death than white men with metastatic castration resistant prostate cancer (mCRPC) treated with a', 'Men of Diverse Ethnic s with Metastatic Castration Resistant Prostate Cancer', 'Of 8,820 patients, 7,528 (85%) were white, 500 (6%) were black, 424 were Asian (5%) and 368 (4%) had race unspecified', 'Individual patient data from 8,820 mCRPC men randomized on nine phase III trials to DP-containing regimen were combined']",['docetaxel (D) and prednisone (P)-based regimen'],"['Median PSA PFS', 'Median PFS', 'progression-free survival (PFS), biochemical PFS, ≥50% decline in PSA from baseline and objective response rate (ORR']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",8820.0,0.269513,"Median PSA PFS were 9.7 months (95% CI 9.4-10), 8.5 months (95% CI 7.6-10) and 10.0 (95% CI 9.5-11.8) in white, black and Asian men, respectively.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Duke University Medical Center and Duke University, Durham, USA. Electronic address: susan.halabi@duke.edu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Old Dominion University, Norfolk, USA.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rosenthal', 'Affiliation': 'The Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale School of Medicine, New Haven, USA.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'Christus San Rosa Hospital Medical Center, San Antonio, USA.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'British Columbia Cancer Agency - Vancouver Centre, Vancouver, Canada.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'De Bono', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, Sutton, UK.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Araujo', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Logothetis', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Eisenberger', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, USA.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center, Los Angeles, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'University of Washington and Fred Hutchinson Cancer Research Center, Seattle, USA.'}, {'ForeName': 'I F', 'Initials': 'IF', 'LastName': 'Tannock', 'Affiliation': 'Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California, San Francisco, San Francisco, USA.'}, {'ForeName': 'W K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.03.309']
29,32354362,Septoplasty versus non-surgical management for nasal obstruction in adults with a deviated septum: economic evaluation alongside a randomized controlled trial.,"BACKGROUND
For years, the benefits of septoplasty have been questioned. Due to the scarce and inconclusive literature, several National Health Service (NHS) Clinical Commissioning Groups in England decided to add septal surgery to their list of restricted procedures with low clinical value. Recently, evidence was obtained that septoplasty is actually more effective than non-surgical management for nasal obstruction in adults with a deviated septum. However, the relation between costs and effects of septoplasty remains unknown.
METHODS
We conducted an economic evaluation alongside an open, multicenter, pragmatic randomized controlled trial in two tertiary and 16 secondary referral hospitals in the Netherlands. Adults with nasal obstruction and a deviated septum were randomized to (1) septoplasty with or without concurrent turbinate surgery or (2) non-surgical management consisting of (a combination of) medical treatment and watchful waiting. Analyses were performed on an intention-to-treat basis. Single imputation nested in the bootstrap percentile method (using 5000 bootstrap replications) was performed to assess the effect of missing data. After 12 and 24 months, we assessed the incremental costs per quality-adjusted life year (QALY) gained from a healthcare and a societal perspective.
RESULTS
A total of 203 adults were randomly assigned to septoplasty (N = 102) or non-surgical management (N = 101). After 12 months, the mean cost difference between septoplasty and non-surgical management using a healthcare or societal perspective was €1181 (95%CI €1038 to €1323) or €2192 per patient (95%CI €1714 to €2670), respectively. The mean QALY difference was 0.03 per patient (95%CI - 0.01 to 0.07). Incremental costs per QALY gained from a healthcare or societal perspective were €41,763 or €77,525, respectively. After 24 months, the mean cost difference between the two groups using a healthcare or societal perspective decreased to €936 (95%CI €719 to €1153) or €1671 per patient (95%CI €952 to €2390), respectively. The mean QALY difference increased to 0.05 per patient (95%CI - 0.03 to 0.14). Incremental costs per QALY gained from a healthcare or societal perspective became €17,374 or €31,024, respectively. Analyses of imputed data did not alter our findings.
CONCLUSIONS
Depending on the selected perspective, cost-effectiveness threshold, and time horizon, septoplasty has the potential to be cost-effective. Despite considerable uncertainty, septoplasty seems to be cost-effective from a healthcare perspective, after 24 months against a threshold of €20,000 per QALY. From a societal perspective, septoplasty is not yet cost-effective after 24 months, but it comes closer to the cost-effectiveness threshold as time passes by.
TRIAL REGISTRATION
Nederlands Trial Register, NTR3868 (https://www.trialregister.nl/trial/3698). Prospectively registered on February 21, 2013.",2020,"Incremental costs per QALY gained from a healthcare or societal perspective were €41,763 or €77,525, respectively.","['203 adults', 'Adults with nasal obstruction and a deviated septum', 'two tertiary and 16 secondary referral hospitals in the Netherlands', 'adults with a deviated septum']","['septoplasty with or without concurrent turbinate surgery or (2) non-surgical management consisting of (a combination of) medical treatment and watchful waiting', 'septoplasty (N\u2009=\u2009102) or non-surgical management', 'Septoplasty versus non-surgical management']","['mean QALY difference', 'mean cost difference', 'healthcare or societal perspective', 'incremental costs per quality-adjusted life year (QALY) gained from a healthcare and a societal perspective']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0549397', 'cui_str': 'Deviated nasal septum'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C3658282', 'cui_str': 'Secondary Referral Center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0752060', 'cui_str': 'Septum of Brain'}]","[{'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C1266928', 'cui_str': 'Nasal turbinate bone structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",203.0,0.180953,"Incremental costs per QALY gained from a healthcare or societal perspective were €41,763 or €77,525, respectively.","[{'ForeName': 'M M H T', 'Initials': 'MMHT', 'LastName': 'van Egmond', 'Affiliation': 'Department of Otorhinolaryngology, Radboud Institute for Health Sciences, Radboud University Medical Center, Route 377, P.O. Box 9101, 6500 HB, Nijmegen, the Netherlands. Machteld.vanEgmond@radboudumc.nl.'}, {'ForeName': 'J P C', 'Initials': 'JPC', 'LastName': 'Grutters', 'Affiliation': 'Department of Operating Rooms, Radboud Institute for Health Sciences, Radboud University Medical Center, Route 715, P.O. Box 9101, 6500 HB, Nijmegen, the Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hannink', 'Affiliation': 'Department of Operating Rooms, Radboud Institute for Health Sciences, Radboud University Medical Center, Route 715, P.O. Box 9101, 6500 HB, Nijmegen, the Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'van Heerbeek', 'Affiliation': 'Department of Otorhinolaryngology, Radboud Institute for Health Sciences, Radboud University Medical Center, Route 377, P.O. Box 9101, 6500 HB, Nijmegen, the Netherlands.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Rovers', 'Affiliation': 'Department of Operating Rooms, Radboud Institute for Health Sciences, Radboud University Medical Center, Route 715, P.O. Box 9101, 6500 HB, Nijmegen, the Netherlands.'}]",BMC medicine,['10.1186/s12916-020-01562-5']
30,32367786,A pilot feasibility study of a group-delivered cancer parenting program: Enhancing Connections-Group.,"Objective: The purpose of this study was to examine the feasibility and short-term impact of a 5-session fully manualized, group-delivered cancer parenting education program to diagnosed parents or surrogate parents with a school-age child. Design: Single group, pre-post-test design with intent to treat analysis. Sample: A total of 16 parents completed the program who were diagnosed within 12 months with non-metastatic cancer of any type (Stages 0-III), read and wrote English, had a child 5-17 years old who knew the parent's diagnosis. Methods: Assessments occurred at baseline and at 2 months post-baseline on standardized measures of parental depressed mood, anxiety, parenting self-efficacy, parenting quality, parenting skills and child behavioral-emotional adjustment. Findings/Results: The program was feasible and well accepted: 16/18 (89%) of the enrolled participants were included in the intent to treat analysis. Program staff were consistently positive and enthusiastic about the demonstrated skills they observed in group attendees during the group-delivered sessions, including the emergence of support between attendees. Outcomes on all measures improved between baseline and post-intervention; changes were statistically significant on measures of parents' anxiety, parents' self-efficacy, parents' skills, and parenting quality. Conclusions: The group-delivered Enhancing Connections cancer parenting program has potential to improve behavioral-emotional outcomes on standardized measures of skills and emotional adjustment in parents, parent-surrogates and children. Future testing is warranted. Implications for Psychosocial Providers: After a brief training, a fully manualized cancer parenting program can enhance parenting competencies and parent-reported child outcomes.",2020,"Outcomes on all measures improved between baseline and post-intervention; changes were statistically significant on measures of parents' anxiety, parents' self-efficacy, parents' skills, and parenting quality.","['diagnosed parents or surrogate parents with a school-age child', ""16 parents completed the program who were diagnosed within 12\u2009months with non-metastatic cancer of any type (Stages 0-III), read and wrote English, had a child 5-17\u2009years old who knew the parent's diagnosis""]","['group-delivered cancer parenting program: Enhancing Connections-Group', '5-session fully manualized, group-delivered cancer parenting education program', 'Enhancing Connections cancer parenting program']","['standardized measures of parental depressed mood, anxiety, parenting self-efficacy, parenting quality, parenting skills and child behavioral-emotional adjustment', ""parents' anxiety, parents' self-efficacy, parents' skills, and parenting quality""]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0337467', 'cui_str': 'Surrogate parent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441763', 'cui_str': 'Stage 0'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205309', 'cui_str': 'Known'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0242261', 'cui_str': 'Parenting education'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0557904', 'cui_str': 'Emotional adjustment'}]",16.0,0.0272125,"Outcomes on all measures improved between baseline and post-intervention; changes were statistically significant on measures of parents' anxiety, parents' self-efficacy, parents' skills, and parenting quality.","[{'ForeName': 'Frances Marcus', 'Initials': 'FM', 'LastName': 'Lewis', 'Affiliation': 'School of Nursing, University of Washington, Seattle, Washington, D.C., USA.'}, {'ForeName': 'Ellen H', 'Initials': 'EH', 'LastName': 'Zahlis', 'Affiliation': 'School of Nursing, University of Washington, Seattle, Washington, D.C., USA.'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Shands', 'Affiliation': 'School of Nursing, University of Washington, Seattle, Washington, D.C., USA.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Griffith', 'Affiliation': 'School of Nursing, University of Washington, Seattle, Washington, D.C., USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Goldberger', 'Affiliation': 'Cancer Support Community, New York, New York, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shaft', 'Affiliation': ""Gilda's Club Quad Cities, Davenport, Iowa, USA.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kennedy', 'Affiliation': ""Christ Medical Center, Gilda's Club Chicago, Chicago, Illinois, USA.""}, {'ForeName': 'Aly', 'Initials': 'A', 'LastName': 'Rice', 'Affiliation': 'Cancer Support Community Greater Philadelphia, Warminster, Pennsylvania, USA.'}]",Journal of psychosocial oncology,['10.1080/07347332.2020.1745987']
31,32368717,Comparative Survival of Asian and White Metastatic Castration-Resistant Prostate Cancer Men Treated With Docetaxel.,"There are few data regarding disparities in overall survival (OS) between Asian and white men with metastatic castration-resistant prostate cancer (mCRPC). We compared OS of Asian and white mCRPC men treated in phase III clinical trials with docetaxel and prednisone (DP) or a DP-containing regimen. Individual participant data from 8820 men with mCRPC randomly assigned on nine phase III trials to receive DP or a DP-containing regimen were combined. Men enrolled in these trials had a diagnosis of prostate adenocarcinoma. The median overall survival was 18.8 months (95% confidence interval [CI] = 17.4 to 22.1 months) and 21.2 months (95% CI = 20.8 to 21.7 months) for Asian and white men, respectively. The pooled hazard ratio for death for Asian men compared with white men, adjusted for baseline prognostic factors, was 0.95 (95% CI = 0.84 to 1.09), indicating that Asian men were not at increased risk of death. This large analysis showed that Asian men did not have shorter OS duration than white men treated with docetaxel.",2020,"The median overall survival was 18.8 months (95% confidence interval [CI] = 17.4 to 22.1 months) and 21.2 months (95% CI = 20.8 to 21.7 months) for Asian and white men, respectively.","['8820 men with mCRPC randomly assigned on nine phase III trials to receive', 'Asian and White Metastatic Castration-Resistant Prostate Cancer Men Treated With', 'Asian and white mCRPC men treated in phase III clinical trials with', 'Men enrolled in these trials had a diagnosis of prostate adenocarcinoma', 'Asian and white men with metastatic castration-resistant prostate cancer (mCRPC']","['docetaxel and prednisone (DP', 'docetaxel', 'DP or a DP-containing regimen', 'Docetaxel']","['pooled hazard ratio for death', 'risk of death', 'median overall survival', 'OS duration', 'overall survival (OS']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007112', 'cui_str': 'Adenocarcinoma of prostate'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",8820.0,0.16606,"The median overall survival was 18.8 months (95% confidence interval [CI] = 17.4 to 22.1 months) and 21.2 months (95% CI = 20.8 to 21.7 months) for Asian and white men, respectively.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, School of Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Mathematics and Statistics, Old Dominion University, Norfolk, VA, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, Parkville, Australia.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Medical Oncology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'President, Christus San Rosa Hospital Medical Center, San Antonio, TX, USA.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'Medical Oncology, British Columbia Cancer Agency - Vancouver Centre, Vancouver, BC, USA.'}, {'ForeName': 'Johann S', 'Initials': 'JS', 'LastName': 'De Bono', 'Affiliation': 'Division of Clinical Studies, The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, Sutton, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Araujo', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Logothetis', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Eisenberger', 'Affiliation': 'Oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'Genitourinary Oncology, Department of Medicine University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Medical Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Genitourinary Oncology Service, Department of Medicine. Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Celestia S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Ian F', 'Initials': 'IF', 'LastName': 'Tannock', 'Affiliation': 'Department of Medical Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'Department of Medicine, and University of California San Francisco Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'William Kevin', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Medical Oncology and Urology, Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, PA, USA.'}]",JNCI cancer spectrum,['10.1093/jncics/pkaa003']
32,32366214,Individualized intervention for frail non-dialysis elderly patients with chronic kidney disease: protocol for a randomized controlled trial.,"BACKGROUND
Frailty describes an age-related clinical state and can be regarded as a predictive factor for fall, disability, hospitalization, and death in the elderly. Previous studies proved that frailty could be reversed or attenuated by multi-disciplinary intervention. However, only a few studies have been performed in non-dialysis patients with chronic kidney disease.
METHODS
A randomized parallel controlled trial will be conducted to compare an individualized intervention according to the consequence of the comprehensive geriatric assessment with routine treatment. A total of 242 individuals aged ≥65 years, who fulfill the Fried Phenotype of frailty and have chronic kidney disease stage 3-5 without dialysis will be recruited from the Department of Nephrology and Department of Internal Medicine, Beijing Chaoyang Hospital, Capital Medical University. The participants will be followed-up for 30 days and 12 months.
DISCUSSION
This protocol would be established to examine the efficiency of targeted intervention for frailty. If a positive consequence could be obtained, a novel treatment for frail elderly patients with chronic kidney disease who have never undergone dialysis can be carried out in routine clinical practice.
TRIAL REGISTRATION
The trial was prospectively registered at the Chinese Clinical Trials Registry with the registration number ChiCTR-IOR-17013429 on November 17, 2017.",2020,"A total of 242 individuals aged ≥65 years, who fulfill the Fried Phenotype of frailty and have chronic kidney disease stage 3-5 without dialysis will be recruited from the Department of Nephrology and Department of Internal Medicine, Beijing Chaoyang Hospital, Capital Medical University.","['242 individuals aged ≥65\u2009years, who fulfill the Fried Phenotype of frailty and have chronic kidney disease stage 3-5 without dialysis will be recruited from the Department of Nephrology and Department of Internal Medicine, Beijing Chaoyang Hospital, Capital Medical University', 'frail elderly patients with chronic kidney disease who have never undergone dialysis', 'frail non-dialysis elderly patients with chronic kidney disease', 'non-dialysis patients with chronic kidney disease', 'Chinese Clinical Trials Registry with the registration number ChiCTR-IOR-17013429 on November 17, 2017']","['Individualized intervention', 'individualized intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],242.0,0.0866611,"A total of 242 individuals aged ≥65 years, who fulfill the Fried Phenotype of frailty and have chronic kidney disease stage 3-5 without dialysis will be recruited from the Department of Nephrology and Department of Internal Medicine, Beijing Chaoyang Hospital, Capital Medical University.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Gong-Ti South Road 8#, Chao-Yang District, Beijing, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Internal Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Gong-Ti South Road 8#, Chao-Yang District, Beijing, China.'}, {'ForeName': 'Xiang-Yang', 'Initials': 'XY', 'LastName': 'Fang', 'Affiliation': 'Department of Internal Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Gong-Ti South Road 8#, Chao-Yang District, Beijing, China.'}, {'ForeName': 'Su-Mei', 'Initials': 'SM', 'LastName': 'Zhao', 'Affiliation': 'Department of Nephrology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuan-Ping', 'Initials': 'YP', 'LastName': 'Hou', 'Affiliation': 'Department of Internal Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Gong-Ti South Road 8#, Chao-Yang District, Beijing, China.'}, {'ForeName': 'Qian-Mei', 'Initials': 'QM', 'LastName': 'Sun', 'Affiliation': 'Department of Internal Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Gong-Ti South Road 8#, Chao-Yang District, Beijing, China. sunqianmei5825@126.com.'}]",BMC geriatrics,['10.1186/s12877-020-1491-6']
33,32366224,"Effectiveness of lidocaine/prilocaine cream on cardiovascular reactions from endotracheal intubation and cough events during recovery period of older patients under general anesthesia: prospective, randomized placebo-controlled study.","BACKGROUND
Endotracheal intubation is known to pose significant physiological, pharmacokinetic, and dynamic changes and postoperative respiratory complications in patients under general anesthesia.
METHOD
An RCT trial was organized by the Third Affiliated Hospital at Sun Yat-sen University, China. Patients were eligible for inclusion in the trial if they were over 60 years old and had upper-abdominal surgery during the induction of anesthesia and had enrolled in endotracheal intubations. The primary end point included cardiovascular reactions during the induction of anesthesia and endotracheal intubations and cough events during the recovery period. In the test group, 2 g of lidocaine/prilocaine cream (and in the control group, 2 g of Vaseline) were laid over the surface of the tracheal tube cuff.
RESULTS
The systolic blood pressure (F value = 62.271, p < 0.001), diastolic blood pressure (F value = 150.875, p < 0.001), and heart rate (F value = 75.627, p < 0.001) of the test group were significantly lower than the control group. Cough events during the recovery period in the test group were better (spontaneous cough, χ 2 value = 10.591, p < 0.001; induced cough, χ 2 value =10.806, p < 0.001).
CONCLUSION
In older patients, coughing and cardiovascular reactions under anesthesia and endotracheal intubations were reduced, as a result of using lidocaine/prilocaine cream on the surface of the tracheal tube cuff.
TRIAL REGISTRATION
International Clinical Trials Network NCT02017392, 2013-12-16.",2020,"Cough events during the recovery period in the test group were better (spontaneous cough, χ 2 value = 10.591, p < 0.001; induced cough, χ 2 value =10.806, p < 0.001).
","['older patients under general anesthesia', 'Patients were eligible for inclusion in the trial if they were over 60\u2009years old and had upper-abdominal surgery during the induction of anesthesia and had enrolled in endotracheal intubations', '2013-12-16', 'patients under general anesthesia']","['lidocaine/prilocaine cream', 'Vaseline', 'placebo']","['coughing and cardiovascular reactions', 'heart rate', 'cardiovascular reactions during the induction of anesthesia and endotracheal intubations and cough events', 'systolic blood pressure', 'diastolic blood pressure', 'cardiovascular reactions from endotracheal intubation and cough events', 'Cough events']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0617623', 'cui_str': 'Lidocaine- and prilocaine-containing product'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0728774', 'cui_str': 'Vaseline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.0389615,"Cough events during the recovery period in the test group were better (spontaneous cough, χ 2 value = 10.591, p < 0.001; induced cough, χ 2 value =10.806, p < 0.001).
","[{'ForeName': 'Linsheng', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'Operation Room, the third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Shanghai Shyndec Pharmaceutical Co., Ltd, Shanghai, 600420, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Division of Nephrology, the third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China. naturestyle@163.com.'}, {'ForeName': 'Miaoxia', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Nursing Department, the third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China. 1109986151@qq.com.'}]",BMC geriatrics,['10.1186/s12877-020-01567-y']
34,32359666,Abstinence outcomes among women in reproductive health centers administered clinician or electronic brief interventions.,"Treatment of substance use in women seeking reproductive healthcare is crucial for the health of both women and their offspring. Although abstinence from all substance use during pregnancy is optimal, it is difficult to achieve. This secondary analysis reports abstinence outcomes from a randomized clinical trial of screening, brief intervention, and referral to treatment (SBIRT) for substance use among women seeking reproductive healthcare services. Women who screened positive for substance use were randomly assigned to either clinician-administered SBIRT, an electronically-administered brief intervention (e-SBIRT), or an enhanced usual care condition. At a 6-month follow-up assessment, compared to enhanced usual care, the clinician-administered SBIRT increased 1-month point prevalence of abstinence from the primary substance by 7.7%, and e-SBIRT increased abstinence by 12.8%. Both brief interventions were more useful than enhanced usual care and could increase substance use abstinence rates among women in reproductive healthcare clinics. The electronic brief intervention is particularly attractive given that it appears as efficacious as, but requires fewer resources than, clinician-delivered brief interventions.",2020,Both brief interventions were more useful than enhanced usual care and could increase substance use abstinence rates among women in reproductive healthcare clinics.,"['Women who screened positive for substance use', 'women in reproductive health centers administered clinician or electronic brief interventions', 'women seeking reproductive healthcare services', 'women in reproductive healthcare clinics', 'women seeking reproductive healthcare']","['clinician-administered SBIRT, an electronically-administered brief intervention (e-SBIRT), or an enhanced usual care condition', 'screening, brief intervention, and referral to treatment (SBIRT']","['Abstinence outcomes', 'substance use abstinence rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0557829', 'cui_str': 'Healthcare services'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]",,0.0489737,Both brief interventions were more useful than enhanced usual care and could increase substance use abstinence rates among women in reproductive healthcare clinics.,"[{'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Yonkers', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, 300 George Street, New Haven, CT 06511, USA; Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, USA; Department of Epidemiology and Public Health, Yale School of Medicine, 60 College Street, New Haven, CT 06510, USA. Electronic address: Kimberly.Yonkers@yale.edu.'}, {'ForeName': 'Jason I', 'Initials': 'JI', 'LastName': 'Dailey', 'Affiliation': 'Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, MD 20814, USA. Electronic address: Jason.I.Dailey.mil@mail.mil.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gilstad-Hayden', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, 300 George Street, New Haven, CT 06511, USA. Electronic address: Kathryn.Gilstad-Hayden@yale.edu.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Ondersma', 'Affiliation': 'Wayne State University, Merrill Palmer Skillman Institute, 71 E. Ferry Ave, Detroit, MI 48202, USA. Electronic address: s.ondersma@wayne.edu.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Forray', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, 300 George Street, New Haven, CT 06511, USA. Electronic address: Ariadna.Forray@yale.edu.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Olmstead', 'Affiliation': 'University of Texas at Austin, PO Box Y, Austin, TX 78713, USA. Electronic address: TOlmstead@austin.utexas.edu.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, 300 George Street, New Haven, CT 06511, USA; VA Connecticut Healthcare System, 950 Campbell Avenue, West Haven, CT 06516, USA. Electronic address: Steve.Martino@yale.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.02.012']
35,32359668,Impact of methadone treatment initiated in jail on subsequent arrest.,"BACKGROUND
There are limited data from randomized trials about the impact of starting methadone treatment in jail on subsequent arrest after release for adults with opioid use disorder (OUD).
METHODS
Official arrest records were obtained for 212 participants with OUD who were enrolled in a three-group randomized controlled trial of initiating methadone treatment in jail either with or without patient navigation vs. enhanced treatment-as-usual in Baltimore, Maryland. Participants treated for opioid withdrawal in jail were assigned to: 1) interim methadone (IM) with patient navigation (PN; IM + PN); 2) IM without PN (IM); or 3) enhanced treatment-as-usual (ETAU). Participants in both IM groups were able to continue treatment at a community-based methadone treatment program with counseling upon release, while ETAU participants received overdose information and a city-wide treatment assessment/referral number. Likelihood of arrest, time to first subsequent arrest, and severity of arrest charges in the 12 months following release were examined for: 1) combined IM + PN and IM groups compared to ETAU; and 2) IM + PN compared to IM.
RESULTS
Within 12 months of release from the index incarceration, 50.5% of the sample had been arrested. The majority of arrest charges (71%) were for low-level, nonviolent crimes. On an intention-to-treat basis, there were no significant differences between the combined IM + PN and IM groups vs. ETAU or IM + PN vs. IM in the likelihood of arrest, time to first subsequent arrest, or severity of arrest charges.
CONCLUSION
Initiating IM with or without PN during pretrial detention did not have a significant effect on subsequent arrest during a 12-month post-release follow-up compared to not starting methadone maintenance during detention, despite the high rate of methadone treatment entry in the community following release. This finding may be attributable to the considerable attrition from treatment in the community or other systematic factors. Additional interventions may be needed to reduce the likelihood of subsequent arrest.",2020,"On an intention-to-treat basis, there were no significant differences between the combined IM + PN and IM groups vs. ETAU or IM + PN vs. IM in the likelihood of arrest, time to first subsequent arrest, or severity of arrest charges.
","['jail on subsequent arrest', 'Official arrest records were obtained for 212 participants with OUD who were enrolled in a three-group randomized controlled trial of initiating', 'adults with opioid use disorder (OUD']","['methadone treatment program with counseling upon release, while ETAU participants received overdose information and a city-wide treatment assessment/referral number', 'methadone treatment in jail either with or without patient navigation vs. enhanced treatment-as-usual in Baltimore, Maryland', 'methadone', 'methadone (IM) with patient navigation (PN; IM\xa0+\xa0PN); 2) IM without PN (IM); or 3) enhanced treatment-as-usual (ETAU']","['Likelihood of arrest, time to first subsequent arrest, and severity of arrest charges']","[{'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0007961', 'cui_str': 'Charges'}]",212.0,0.0854779,"On an intention-to-treat basis, there were no significant differences between the combined IM + PN and IM groups vs. ETAU or IM + PN vs. IM in the likelihood of arrest, time to first subsequent arrest, or severity of arrest charges.
","[{'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Kelly', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address: skelly@friendsresearch.org.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address: rschwartz@friendsresearch.org.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, MD, USA. Electronic address: ogrady@umd.edu.'}, {'ForeName': 'Shannon G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address: smitchell@friendsresearch.org.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Duren', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address: tduren@friendsresearch.org.'}, {'ForeName': 'Anjalee', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address: asharma@friendsresearch.org.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Jaffe', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address: jhjaffe@aol.com.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108006']
36,32359674,Pilot trial investigating a brief behavioral economic intervention as an adjunctive treatment for alcohol use disorder.,"OBJECTIVE
Behavioral economic research suggests that increasing the salience of a delayed reward may improve capacity for delaying gratification and increase behavior allocated toward obtaining larger, delayed substance-free reward rather than smaller, more immediate reward such as alcohol use. This study aimed to improve the efficacy of outpatient alcohol use disorder (AUD) treatment by adding elements that target behavioral economic mechanisms of change.
METHOD
Forty-one (N = 41) adults in outpatient AUD treatment were recruited and 37 participants were retained at follow-up. Following baseline assessment, participants received either the Substance Free Activity Session (SFAS), a single-session behavioral economic-informed intervention focused on increasing future orientation and engagement in values-based substance-free activities or a health education control intervention. Participants in both conditions received weekly prompts (via text or email) relevant to their respective intervention for four weeks. Participants (68.3% male; 70.7% Caucasian, M age = 38.24, SD = 12.69) reported an average of 3.95 (SD = 4.72) binge drinking episodes (4/5 drinks per occasion for a woman/man) and 5.05 (SD = 5.32) drinks per drinking day 30-days prior to treatment entry.
RESULTS
The study provided initial support for the feasibility and acceptability of implementing the SFAS within a treatment setting. Participants reported high levels of satisfaction with the SFAS (M = 9.08 (SD = 0.94), on a scale of 1-10). At 3-month follow-up, the SFAS was associated with reductions in the proportion of activity participation and enjoyment (reinforcement) related to substance-use relative to substance-free activities and in alcohol demand compared to control.
CONCLUSION
These preliminary results provide initial support for targeting behavioral economic mechanisms of change in an outpatient AUD treatment with a single-session intervention plus remote delivery of booster prompts.",2020,"At 3-month follow-up, the SFAS was associated with reductions in the proportion of activity participation and enjoyment (reinforcement) related to substance-use relative to substance-free activities and in alcohol demand compared to control.
","['Forty-one', 'N\xa0=\xa041) adults in outpatient AUD treatment were recruited and 37 participants were retained at follow-up', 'Participants (68.3% male; 70.7% Caucasian, M age\xa0=\xa038.24, SD\xa0=\xa012.69) reported an average of 3.95 (SD\xa0=\xa04.72) binge drinking episodes (4/5 drinks per occasion for a woman/man) and 5.05 (SD\xa0=\xa05.32) drinks per drinking day']","['behavioral economic intervention', 'Substance Free Activity Session (SFAS), a single-session behavioral economic-informed intervention focused on increasing future orientation and engagement in values-based substance-free activities or a health education control intervention']",['proportion of activity participation and enjoyment (reinforcement'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}]",41.0,0.0368838,"At 3-month follow-up, the SFAS was associated with reductions in the proportion of activity participation and enjoyment (reinforcement) related to substance-use relative to substance-free activities and in alcohol demand compared to control.
","[{'ForeName': 'Lidia Z', 'Initials': 'LZ', 'LastName': 'Meshesha', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI 02912, United States of America; Department of Psychology, The University of Memphis, Memphis, TN, United States of America. Electronic address: lidia_meshesha@brown.edu.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Soltis', 'Affiliation': 'Department of Psychology, The University of Memphis, Memphis, TN, United States of America.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Wise', 'Affiliation': 'Mental Health Resources, Memphis, TN, United States of America.'}, {'ForeName': 'Damaris J', 'Initials': 'DJ', 'LastName': 'Rohsenow', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI 02912, United States of America.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, NM, United States of America.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychology, The University of Memphis, Memphis, TN, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108002']
37,32305380,Six-year results of a randomized controlled clinical trial of two glass ionomer cements in class II cavities.,"OBJECTIVES
Long-term survival of two highly viscous glass ionomer cements (Fuji IX GP Fast and Equia Fil) over a period of 6 years in vivo.
METHODS
A total of 85 two- or three-surface class II restorations, comprising 43 Equia Fil / Equia Coat and 42 Fuji IX GP Fast / Fuji Coat LC, were placed in 34 patients. The restorations were re-evaluated after 6 years using the FDI criteria. The statistical analysis was performed with Fisher's exact test, the Wilcoxon signed-rank test, the Mann-Whitney U test and the Kaplan-Meier method.
RESULTS
Forty-four restorations (22 Equia Fil and 22 Fuji IX GP Fast) could be assessed at the 6-year follow-up. During the whole study period, eight failures, four for each material, were observed. The main reasons for failure were material fractures and retention loss, which were partly combined with poor marginal adaptation or poor proximal anatomical form. Two failures may be attributed to insufficient application of the materials, as suspected according to the radiographs. The Kaplan-Meier survival proportion for Equia Fil restorations at 6 years was 86.5% and that for Fuji IX GP Fast at 6 years was 86.8% (log-rank p = 0.907). During the period from 3 to 6 years, only one filling in each group failed.
CONCLUSION
Both materials showed acceptable and comparable survival rates after 6 years.
CLINICAL SIGNIFICANCE
Highly viscous glass ionomer cement can be an acceptable restoration material for smaller class II cavities.",2020,The Kaplan-Meier survival proportion for Equia Fil restorations at 6 years was 86.5% and that for Fuji IX GP Fast at 6 years was 86.8% (log-rank p = 0.907).,['two glass ionomer cements in class II cavities'],[],['survival rates'],"[{'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]",[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0247799,The Kaplan-Meier survival proportion for Equia Fil restorations at 6 years was 86.5% and that for Fuji IX GP Fast at 6 years was 86.8% (log-rank p = 0.907).,"[{'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Heck', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany. Electronic address: kheck@dent.med.uni-muenchen.de.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Frasheri', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Diegritz', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Manhart', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Hickel', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Fotiadou', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103333']
38,32305926,Alpha Frequency Intervention by Electrical Stimulation to Improve Performance in Mu-Based BCI.,"The accuracy of brain-computer interfaces (BCIs) is important for effective communication and control. The mu-based BCI is one of the most widely used systems, of which the related methods to improve users' accuracy are still poorly studied, especially for the BCI illiteracy. Here, we examined a way to enhance mu-based BCI performance by electrically stimulating the ulnar nerve of the contralateral wrist at the alpha frequency (10 Hz) during left- and right-hand motor imagination in two BCI groups (literate and illiterate). We demonstrate that this alpha frequency intervention enhances the classification accuracy between left- and right-hand motor imagery from 66.41% to 81.57% immediately after intervention and to 75.28% two days after intervention in the BCI illiteracy group, while classification accuracy improves from 82.12% to 91.84% immediately after intervention and to 89.03% two days after intervention in the BCI literacy group. However, the classification accuracy did not change before and after the sham intervention (no electrical stimulation). Furthermore, the ERD on the primary sensorimotor cortex during left- or right-hand motor imagery tasks was more visible at the mu-rhythm (8-13 Hz) after alpha frequency intervention. Alpha frequency intervention increases the mu-rhythm power difference between left- and right-hand motor imagery tasks. These results provide evidence that alpha frequency intervention is an effective way to improve BCI performance by regulating the mu-rhythm which might provide a way to reduce BCI illiteracy.",2020,"Furthermore, the ERD on the primary sensorimotor cortex during left-or right-hand motor imagery tasks was more visible at the mu-rhythm (8-13 Hz) after alpha frequency intervention.",[],['Alpha Frequency Intervention by Electrical Stimulation'],"['enhance mu-based BCI performance', 'BCI performance']",[],"[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2742590', 'cui_str': '2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one'}]",,0.0148878,"Furthermore, the ERD on the primary sensorimotor cortex during left-or right-hand motor imagery tasks was more visible at the mu-rhythm (8-13 Hz) after alpha frequency intervention.","[{'ForeName': 'Xiangzi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yaqiu', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Boyu', 'Initials': 'B', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Jinyi', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2020.2987529']
39,32371553,Reasons for Not Attending Cervical Cancer Screening and Associated Factors in Rural Ethiopia.,"Social, economic, and cultural factors have been associated with the level of participation in cervical cancer screening programs. This study identified factors associated with nonparticipation in cervical cancer screening, as well as reasons for not attending, in the context of a population-based, cluster-randomized trial in Ethiopia. A total of 2,356 women aged 30 to 49 years in 22 clusters were invited to receive one of two screening approaches, namely human papillomavirus (HPV) self-sampling or visual inspection with acetic acid (VIA). Participants and nonparticipants were analyzed according to their sociodemographic and economic characteristics. Reasons were determined for the refusal of women to participate in either screening method. More women in the VIA arm compared to the HPV arm declined participation in the screening [adjusted OR (AOR) 3.5; 95% confidence interval (CI), 2.6-4.8]. Women who declined attending screening were more often living in rural areas (AOR = 2.0; 95% CI, 1.1-3.5) and were engaged in informal occupations (AOR = 1.6; 95% CI, 1.1-2.4). The majority of nonattendants perceived themselves to be at no risk of cervical cancer (83.1%). The main reasons given for not attending screening for both screening approaches were lack of time to attend screening, self-assertion of being healthy, and fear of screening. We found that perceived time constraints and the perception of being at no risk of getting the disease were the most important barriers to screening. Living in rural settings and informal occupation were also associated with lower participation. Offering a swift and convenient screening service could increase the participation of women in cervical cancer screening at the community level.",2020,The majority of nonattendants perceived themselves to be at no risk of cervical cancer (83.1%).,"['2,356 women aged 30 to 49 years in 22 clusters']","['screening approaches, namely human papillomavirus (HPV) self-sampling or visual inspection with acetic acid (VIA']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}]",[],2356.0,0.0669526,The majority of nonattendants perceived themselves to be at no risk of cervical cancer (83.1%).,"[{'ForeName': 'Muluken', 'Initials': 'M', 'LastName': 'Gizaw', 'Affiliation': 'Department of Preventive Medicine, School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Brhanu', 'Initials': 'B', 'LastName': 'Teka', 'Affiliation': 'Department of Microbiology, Immunology and Parasitology, School of Medicine, Addis Ababa University, Ethiopia.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Ruddies', 'Affiliation': 'Institute for Medical Epidemiology, Biometrics and Informatics, Martin-Luther-University, Halle-Wittenberg, Germany.'}, {'ForeName': 'Konjit', 'Initials': 'K', 'LastName': 'Kassahun', 'Affiliation': 'Pathfinder International, Ethiopia.'}, {'ForeName': 'Dawit', 'Initials': 'D', 'LastName': 'Worku', 'Affiliation': 'Department of Gynecology, School of Medicine, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Alemayehu', 'Initials': 'A', 'LastName': 'Worku', 'Affiliation': 'Department of Preventive Medicine, School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wienke', 'Affiliation': 'Institute for Medical Epidemiology, Biometrics and Informatics, Martin-Luther-University, Halle-Wittenberg, Germany.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Mikolajczyk', 'Affiliation': 'Institute for Medical Epidemiology, Biometrics and Informatics, Martin-Luther-University, Halle-Wittenberg, Germany.'}, {'ForeName': 'Ahmedin', 'Initials': 'A', 'LastName': 'Jemal', 'Affiliation': 'Department of Intramural Research, American Cancer Society, Atlanta, Georgia.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Kaufmann', 'Affiliation': 'Clinic for Gynecology, Charité-Universitätmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Tamrat', 'Initials': 'T', 'LastName': 'Abebe', 'Affiliation': 'Department of Microbiology, Immunology and Parasitology, School of Medicine, Addis Ababa University, Ethiopia.'}, {'ForeName': 'Adamu', 'Initials': 'A', 'LastName': 'Addissie', 'Affiliation': 'Department of Preventive Medicine, School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Eva Johanna', 'Initials': 'EJ', 'LastName': 'Kantelhardt', 'Affiliation': 'Institute for Medical Epidemiology, Biometrics and Informatics, Martin-Luther-University, Halle-Wittenberg, Germany. eva.kantelhardt@uk-halle.de.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0485']
40,32371660,Computerized Cognitive Behavioral Therapy for Substance Use Disorders in a Specialized Primary Care Practice: A Randomized Feasibility Trial to Address the RT Component of SBIRT.,"OBJECTIVES
Screening, Brief Intervention, and Referral to Treatment (SBIRT) has demonstrated efficacy for addressing unhealthy alcohol use in primary care, yet recent research indicates weaker efficacy for drug use as well as very limited success in referral to specialty care for patients with substance use disorder (SUD). Technology-based interventions for SUD delivered in primary care settings are a potential strategy of efficiently delivering treatment to those who need it.
METHODS
We conducted a randomized clinical trial evaluating feasibility, satisfaction, and substance use outcomes for 58 individuals with SUD. Participants being treated in a primary care practice which provides integrated addiction treatment were randomized to standard care or standard care plus access to a web-based SUD intervention (computer-based training in cognitive behavioral therapy, or CBT4CBT). Self-reported substance use and urine toxicology screens were assessed at 8 weeks after randomization.
RESULTS
Uptake of CBT4CBT in this setting was high; 77% of those assigned to this condition accessed the program at least once; of those, 77% completed all 7 modules. Satisfaction with the program was very high. Participants reported >90% days abstinent for all classes of drugs; with no significant differences between conditions.
CONCLUSIONS
This study demonstrates feasibility of implementing technology-based treatments in primary care settings to address weak follow-through with the referral component of SBIRT. The overall positive outcomes in this specialized, integrated treatment setting may have undercut the ability to demonstrate differential effects on substance use; results suggest evaluation in less specialized primary care settings is warranted.
TRIAL REGISTRATION
clinicaltrials.gov NCT03013478.",2020,"Participants reported >90% days abstinent for all classes of drugs; with no significant differences between conditions.
","['patients with substance use disorder (SUD', '58 individuals with SUD', 'Substance Use Disorders in a Specialized Primary Care Practice', 'Participants being treated in a primary care practice which provides integrated addiction treatment']","['standard care or standard care plus access to a web-based SUD intervention (computer-based training in cognitive behavioral therapy, or CBT4CBT', 'Computerized Cognitive Behavioral Therapy']",['Self-reported substance use and urine toxicology screens'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0040541', 'cui_str': 'Toxicology'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",,0.0531905,"Participants reported >90% days abstinent for all classes of drugs; with no significant differences between conditions.
","[{'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Tetrault', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, CT (JMT, SRH, PGO); Department of Psychiatry, Yale University School of Medicine, CT (DAC, MAG, JC, CN, KMC).'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Holt', 'Affiliation': ''}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Cavallo', 'Affiliation': ''}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': ""O'Connor"", 'Affiliation': ''}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Gordon', 'Affiliation': ''}, {'ForeName': 'Joanne K', 'Initials': 'JK', 'LastName': 'Corvino', 'Affiliation': ''}, {'ForeName': 'Charla', 'Initials': 'C', 'LastName': 'Nich', 'Affiliation': ''}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000663']
41,32375659,Framing the numerical findings of Cochrane plain language summaries: two randomized controlled trials.,"BACKGROUND
Cochrane systematic review Plain language Summaries (CSR PLSs should serve as a tool for the evidence translation to non-medical population. However, the evidence of optimal type of numerical presentation in CSR PLSs is still scarce. The aim of this study was to investigate readers' comprehension and preferences for different presentation of findings, including framing and numerical data, in Cochrane systematic review Plain Language Summaries (CSR PLSs).
METHODS
We conducted a parallel randomized trial and a crossover randomized trial at the School of Medicine and family practice offices in Split, Croatia. The participants were students and consumers. We assessed possible differences in comprehension, measured by four questions on PLS content, of CSR PLSs depending on the positive or negative framing of results (n = 91) (Trial 1) or using percentages or frequencies for the presentation of results (n = 245) (Trial 2). The outcome measures were comprehension of PLS content, perceived effectiveness of the treatment and readiness to use the treatment (all on 1-10 scales).
RESULTS
In Trial 1 we found no difference in readers' perception of the effectiveness of the described treatment, desire that the treatment be offered by their family doctor, readiness to use the treatment, or comprehension when CSR PLS results were presented positively or negatively. In Trial 2 we found no difference in CSR PLS comprehension when results were presented as natural frequencies or percentages (BF 10 = 0.62, Bayesian t-test for independent samples).
CONCLUSIONS
Numerical presentation and framing direction of results appear to have no significant impact on understanding of messages in CSR PLSs.
TRIAL REGISTRATION
The trials were registered in ClinicalTrials.gov. Protocol registration numbers: Trial 1: NCT03442387; Trial 2: NCT03554252.",2020,"In Trial 1 we found no difference in readers' perception of the effectiveness of the described treatment, desire that the treatment be offered by their family doctor, readiness to use the treatment, or comprehension when CSR PLS results were presented positively or negatively.","['participants were students and consumers', 'School of Medicine and family practice offices in Split, Croatia']",[],"['comprehension of PLS content, perceived effectiveness of the treatment and readiness to use the treatment (all on 1-10 scales', 'CSR PLS comprehension']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}]",[],"[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.1738,"In Trial 1 we found no difference in readers' perception of the effectiveness of the described treatment, desire that the treatment be offered by their family doctor, readiness to use the treatment, or comprehension when CSR PLS results were presented positively or negatively.","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Buljan', 'Affiliation': 'Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia. ibuljan@mefst.hr.'}, {'ForeName': 'Ružica', 'Initials': 'R', 'LastName': 'Tokalić', 'Affiliation': 'Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Roguljić', 'Affiliation': 'Department of Oral Diseases and Periodontology, University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Zakarija-Grković', 'Affiliation': 'Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}, {'ForeName': 'Davorka', 'Initials': 'D', 'LastName': 'Vrdoljak', 'Affiliation': 'Department of Family Medicine, University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Milić', 'Affiliation': 'University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Puljak', 'Affiliation': 'Center for Evidence-Based Medicine and Health Care, Catholic University of Croatia, Zagreb, Croatia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Marušić', 'Affiliation': 'Department of Research in Biomedicine and Health, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.'}]",BMC medical research methodology,['10.1186/s12874-020-00990-4']
42,32376981,Longitudinal follow-up after telephone disclosure in the randomized COGENT study.,"PURPOSE
To better understand the longitudinal risks and benefits of telephone disclosure of genetic test results in the era of multigene panel testing.
METHODS
Adults who were proceeding with germline cancer genetic testing were randomized to telephone disclosure (TD) with a genetic counselor or in-person disclosure (IPD) (i.e., usual care) of test results. All participants who received TD were recommended to return to meet with a physician to discuss medical management recommendations.
RESULTS
Four hundred seventy-three participants were randomized to TD and 497 to IPD. There were no differences between arms for any cognitive, affective, or behavioral outcomes at 6 and 12 months. Only 50% of participants in the TD arm returned for the medical follow-up appointment. Returning was associated with site (p < 0.0001), being female (p = 0.047), and not having a true negative result (p < 0.002). Mammography was lower at 12 months among those who had TD and did not return for medical follow-up (70%) compared with those who had TD and returned (86%) and those who had IPD (87%, adjusted p < 0.01).
CONCLUSION
Telephone disclosure of genetic test results is a reasonable alternative to in-person disclosure, but attention to medical follow-up may remain important for optimizing appropriate use of genetic results.",2020,"Returning was associated with site (p < 0.0001), being female (p = 0.047), and not having a true negative result (p < 0.002).","['Four hundred seventy-three participants were randomized to TD and 497 to IPD', 'Adults who were proceeding with germline cancer genetic testing']","['telephone disclosure (TD) with a genetic counselor or in-person disclosure (IPD)\xa0(i.e., usual care']","['cognitive, affective, or behavioral outcomes', 'Mammography']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0587719', 'cui_str': 'Genetic counselor'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}]",473.0,0.0669023,"Returning was associated with site (p < 0.0001), being female (p = 0.047), and not having a true negative result (p < 0.002).","[{'ForeName': 'Madison K', 'Initials': 'MK', 'LastName': 'Kilbride', 'Affiliation': 'Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Egleston', 'Affiliation': 'Fox Chase Cancer Center, Temple University Health System, Biostatistics and Bioinformatics Facility, Philadelphia, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hall', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Patrick-Miller', 'Affiliation': 'Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Daly', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Ganschow', 'Affiliation': 'Department of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Generosa', 'Initials': 'G', 'LastName': 'Grana', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Olufunmilayo I', 'Initials': 'OI', 'LastName': 'Olopade', 'Affiliation': 'Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Fetzer', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Brandt', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Chambers', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Dana F', 'Initials': 'DF', 'LastName': 'Clark', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Forman', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Rikki', 'Initials': 'R', 'LastName': 'Gaber', 'Affiliation': 'Department of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Gulden', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Horte', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Long', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Terra', 'Initials': 'T', 'LastName': 'Lucas', 'Affiliation': 'Department of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Shreshtha', 'Initials': 'S', 'LastName': 'Madaan', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mattie', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McKenna', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Montgomery', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Powers', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Rainey', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Rybak', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Savage', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Seelaus', 'Affiliation': 'Department of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Stoll', 'Affiliation': 'Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jill E', 'Initials': 'JE', 'LastName': 'Stopfer', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Xinxin Shirley', 'Initials': 'XS', 'LastName': 'Yao', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Domchek', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'Bradbury', 'Affiliation': 'Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, USA. Angela.Bradbury@uphs.upenn.edu.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-020-0808-3']
43,32385158,Common and dissociable effects of oxytocin and lorazepam on the neurocircuitry of fear.,"Benzodiazepines (BZDs) represent the gold standard of anxiolytic pharmacotherapy; however, their clinical benefit is limited by side effects and addictive potential. Consequently, there is an urgent need to develop novel and safe anxiolytics. The peptide hormone oxytocin (OXT) exhibits anxiolytic-like properties in animals and humans, but whether OXT and BZDs share similar effects on the neural circuitry of fear is unclear. Therefore, the rationale of this ultra-high-field functional MRI (fMRI) study was to test OXT against the clinical comparator lorazepam (LZP) with regard to their neuromodulatory effects on local and network responses to fear-related stimuli. One hundred twenty-eight healthy male participants volunteered in this randomized double-blind, placebo-controlled, between-group study. Before scanning using an emotional face-matching paradigm, participants were randomly administered a single dose of OXT (24 IU), LZP (1 mg), or placebo. On the behavioral level, LZP, but not OXT, caused mild sedation, as evidenced by a 19% increase in reaction times. On the neural level, both OXT and LZP inhibited responses to fearful faces vs. neutral faces within the centromedial amygdala (cmA). In contrast, they had different effects on intra-amygdalar connectivity; OXT strengthened the coupling between the cmA and basolateral amygdala, whereas LZP increased the interplay between the cmA and superficial amygdala. Furthermore, OXT, but not LZP, enhanced the coupling between the cmA and the precuneus and dorsomedial prefrontal cortex. These data implicate inhibition of the cmA as a common denominator of anxiolytic action, with only OXT inducing large-scale connectivity changes of potential therapeutic relevance.",2020,"On the neural level, both OXT and LZP inhibited responses to fearful faces vs. neutral faces within the centromedial amygdala (cmA).",['One hundred twenty-eight healthy male participants volunteered'],"['Benzodiazepines (BZDs', 'oxytocin and lorazepam', 'OXT', 'LZP', 'peptide hormone oxytocin (OXT', 'lorazepam (LZP', 'placebo']","['neurocircuitry of fear', 'reaction times']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0597192', 'cui_str': 'Peptide hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",128.0,0.100533,"On the neural level, both OXT and LZP inhibited responses to fearful faces vs. neutral faces within the centromedial amygdala (cmA).","[{'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Kreuder', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Schultz', 'Affiliation': 'Center for Economics and Neuroscience, University of Bonn, 53113 Bonn, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Hennig', 'Affiliation': 'Division of Personality Psychology and Individual Differences, University of Giessen, 35390 Giessen, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Marsh', 'Affiliation': 'Department of Psychiatry, School of Medicine & Health Sciences, University of Oldenburg, 26129 Oldenburg, Germany.'}, {'ForeName': 'Torge', 'Initials': 'T', 'LastName': 'Dellert', 'Affiliation': 'Institute of Medical Psychology and Systems Neuroscience, University of Muenster, 48149 Muenster, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Ettinger', 'Affiliation': 'Department of Psychology, University of Bonn, 53113 Bonn, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Philipsen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Babasiz', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Herscheid', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Remmersmann', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Ruediger', 'Initials': 'R', 'LastName': 'Stirnberg', 'Affiliation': 'Division of MR Physics, German Center for Neurodegenerative Diseases, 53175 Bonn, Germany.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Stöcker', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany; renehurlemann@icloud.com.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1920147117']
44,32365613,Multi-System Physical Exercise Intervention for Fall Prevention and Quality of Life in Pre-Frail Older Adults: A Randomized Controlled Trial.,"Effective interventions for indicated fall prevention are necessary for older adults with frailty. We aimed to determine the effectiveness of a Multi-system Physical Exercise (MPE) for fall prevention and Health-Related Quality of Life (HRQOL) in pre-frail older adults. This randomized control trial with allocation concealment included 72 adults aged 65 and above, identified as pre-frailty and with mild and moderate fall risk scores measured by the Physiological Profile Assessment (PPA). Randomly, using block randomization, participants were divided into two groups: an MPE group (n = 36) and a control group (n = 36). The intervention consisted mainly of proprioception, muscle strengthening, reaction time, and balance training and was carried out three days per week for 12 weeks. The primary outcome was fall risk assessed using PPA at 12 weeks post-baseline and at a 24 week follow-up. Significant differences were found in the improvement in fall risk, proprioception, muscle strength, reaction time and postural sway, and fear of fall scores in the MPE group compared with controls at week 12 and 24. In addition, HRQOL had increased significantly in the MPE group in comparison to controls. The MPE program significantly increased muscle strength and improved proprioception, reaction time, and postural sway leading to fall risk reduction in older adults with pre-frailty. Therefore, the MPE program is recommended for used in day-to-day primary care practice in the pre-frail population.",2020,"Significant differences were found in the improvement in fall risk, proprioception, muscle strength, reaction time and postural sway, and fear of fall scores in the MPE group compared with controls at week 12 and 24.","['older adults with frailty', 'older adults with pre-frailty', '72 adults aged 65 and above, identified as pre-frailty and with mild and moderate fall risk scores measured by the Physiological Profile Assessment (PPA', 'Pre-Frail Older Adults', 'pre-frail older adults']","['MPE', 'Multi-system Physical Exercise (MPE', 'intervention consisted mainly of proprioception, muscle strengthening, reaction time, and balance training', 'Multi-System Physical Exercise Intervention']","['fall prevention and Health-Related Quality of Life (HRQOL', 'HRQOL', 'fall risk, proprioception, muscle strength, reaction time and postural sway, and fear of fall scores', 'muscle strength and improved proprioception, reaction time, and postural sway leading to fall risk reduction', 'fall risk assessed using PPA', 'Fall Prevention and Quality of Life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",72.0,0.0349773,"Significant differences were found in the improvement in fall risk, proprioception, muscle strength, reaction time and postural sway, and fear of fall scores in the MPE group compared with controls at week 12 and 24.","[{'ForeName': 'Jiraporn', 'Initials': 'J', 'LastName': 'Chittrakul', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Penprapa', 'Initials': 'P', 'LastName': 'Siviroj', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Somporn', 'Initials': 'S', 'LastName': 'Sungkarat', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Ratana', 'Initials': 'R', 'LastName': 'Sapbamrer', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph17093102']
45,32370202,Outcome Expectations for Exercise and Decisional Balance Questionnaires Predict Adherence and Efficacy of Exercise Programs in Dialysis Patients.,"The purpose of this study was to define if Outcomes Expectations for Exercise (OEE) and Decisional Balance (DB) scales predict adherence to guided exercise programs and associate with the improvement in physical performance in the dialysis population. Participants ( n = 40; age 63.6 ± 12.5 years) completed OEE and DB questionnaires before randomization to the experimental group ( n = 20) and control group ( n = 20) of a two-phased exercise program-the experimental group received eight weeks of supervised functional exercise and exercise counseling (1st phase) before commencing eight weeks of home-based exercise on non-dialysis days (2nd phase). Both groups performed intradialytic cycling on dialysis days during both study phases. Patients with above-median OEE and DB scores (>3.15 and >1.3, respectively) expressed significantly better adherence to intradialytic cycling (89% vs. 76%, 89% vs. 77%, respectively, p < 0.05). Experimental group patients with an above-median OEE (but not DB) score had significantly better adherence to supervised and home-based functional exercise (93% vs. 81% and 85% vs. 60%, respectively, p < 0.05). Baseline DB score predicted the final result in the hand-grip test and 6-min walk test. Low OEE and, to a lesser degree, low DB questionnaire scores associate with inferior adherence to dialysis bundled and home-based exercise programs and may help define patient subsets in need of intensified motivational input by exercise caregivers.",2020,"Experimental group patients with an above-median OEE (but not DB) score had significantly better adherence to supervised and home-based functional exercise (93% vs. 81% and 85% vs. 60%, respectively, p < 0.05).","['Participants ( n = 40; age 63.6 ± 12.5 years) completed OEE and DB questionnaires before randomization to the experimental group ( n = 20) and control group ( n = 20) of a', 'dialysis population', 'Dialysis Patients']",['two-phased exercise program-the experimental group received eight weeks of supervised functional exercise and exercise counseling (1st phase) before commencing eight weeks of home-based exercise'],"['Baseline DB score', 'DB scores', 'adherence to supervised and home-based functional exercise', 'low DB questionnaire scores', 'physical performance', 'adherence to intradialytic cycling']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0418878', 'cui_str': 'Recommendation to exercise'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0311714,"Experimental group patients with an above-median OEE (but not DB) score had significantly better adherence to supervised and home-based functional exercise (93% vs. 81% and 85% vs. 60%, respectively, p < 0.05).","[{'ForeName': 'Špela', 'Initials': 'Š', 'LastName': 'Bogataj', 'Affiliation': 'Department of Nephrology, University Medical Centre, 1000 Ljubljana, Slovenia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Pajek', 'Affiliation': 'Faculty of Sport, University of Ljubljana, 1000 Ljubljana, Slovenia.'}, {'ForeName': 'Jadranka', 'Initials': 'J', 'LastName': 'Buturović Ponikvar', 'Affiliation': 'Department of Nephrology, University Medical Centre, 1000 Ljubljana, Slovenia.'}, {'ForeName': 'Jernej', 'Initials': 'J', 'LastName': 'Pajek', 'Affiliation': 'Department of Nephrology, University Medical Centre, 1000 Ljubljana, Slovenia.'}]",International journal of environmental research and public health,['10.3390/ijerph17093175']
46,32371502,Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial.,"OBJECTIVE
Preprocedural bowel preparation is necessary for optimal colonoscopy visualisation. However, it is challenging to achieve high-quality bowel preparation among patients scheduled for colonoscopy. This study aims to evaluate the impact of an intensive patient educational programme on the quality of bowel preparation.
DESIGN
An accessor-blinded randomised controlled trial was carried out at the outpatient surgical clinic of a tertiary hospital. Patients were randomly assigned to the control group (received standard written and verbal instructions) or the experimental group (received an intensive and structured educational programme). All subjects completed a questionnaire before colonoscopy to assess their compliance, acceptability, and tolerability towards bowel preparation regime. Quality of bowel preparation was determined using the Boston Bowel Preparation Scale (BBPS).
RESULTS
A total of 300 subjects who fulfilled the inclusion criteria were recruited. The experimental group had a significantly higher proportion of good quality bowel preparation than the control group (98.7% vs 52.3%, p<0.001). The median total BBPS score was also significantly higher in the experimental group (8 vs 5, p<0.001). Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).
CONCLUSION
An intensive patient educational programme can significantly improve the quality of bowel preparation for colonoscopy.",2020,"Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).
","['patients scheduled for colonoscopy', '300 subjects who fulfilled the inclusion criteria were recruited', 'outpatient surgical clinic of a tertiary hospital']","['control group (received standard written and verbal instructions) or the experimental group (received an intensive and structured educational programme', 'intensive patient educational programme']","['quality of bowel preparation', 'quality of bowel preparation for colonoscopy', 'Boston Bowel Preparation Scale (BBPS', 'good quality bowel preparation', 'Quality of bowel preparation', 'tolerability towards bowel preparation', 'median total BBPS score', 'good quality of bowel preparation included educational programme', 'compliance to bowel cleansing agent']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0008920', 'cui_str': 'Cleansing Agents'}]",300.0,0.233298,"Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).
","[{'ForeName': 'Sivakami', 'Initials': 'S', 'LastName': 'Janahiraman', 'Affiliation': 'Pharmacy, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia sivakami_5@yahoo.com.'}, {'ForeName': 'Chan Yen', 'Initials': 'CY', 'LastName': 'Tay', 'Affiliation': 'Pharmacy, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Jie Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Pharmacy, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Wen Ling', 'Initials': 'WL', 'LastName': 'Lim', 'Affiliation': 'Pharmacy, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Chun Hoe', 'Initials': 'CH', 'LastName': 'Khiew', 'Affiliation': 'Pharmacy, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Ishak', 'Affiliation': 'Surgical, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Zakry Yahya', 'Initials': 'ZY', 'LastName': 'Onn', 'Affiliation': 'Surgical, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Mohd Razali', 'Initials': 'MR', 'LastName': 'Ibrahim', 'Affiliation': 'Surgical, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Chun Keat', 'Initials': 'CK', 'LastName': 'Chew', 'Affiliation': 'Centre for Clinical Trial, Institute for Clinical Research, Shah Alam, Selangor Darul Ehsan, Malaysia.'}]",BMJ open gastroenterology,['10.1136/bmjgast-2020-000376']
47,32372176,"A randomized, double-blind, placebo-controlled trial of testosterone for treatment of postmenopausal women with aromatase inhibitor-induced arthralgias: Alliance study A221102.","PURPOSE
To evaluate the efficacy of testosterone supplementation for improving aromatase inhibitor musculoskeletal symptoms (AIMSS).
METHODS
Postmenopausal women experiencing moderate-to-severe arthralgias while taking adjuvant aromatase inhibitors for breast cancer were enrolled in this trial. Initially, patients were randomly allocated to receive either a subcutaneous testosterone pellet versus a placebo pellet. Due to slow accrual, the protocol was modified such that additional participants were randomized to receive either a topical testosterone gel or a placebo gel. Changes in patient-reported joint pain were compared between patients receiving testosterone and those receiving placebo using a two-sample t test. Changes in hot flashes and other vasomotor symptoms were also analyzed. Further analyses were conducted to evaluate whether 27 single nucleotide polymorphisms (SNPs) in 14 genes previously associated with AIMSS were associated with testosterone supplementation benefit.
RESULTS
While 64% of patients reported an improvement in joint pain at 3 months, there were no significant differences in average pain or joint stiffness at 3 or 6 months between testosterone and placebo arms. Patients receiving testosterone did report improvements in strength, lack of energy, urinary frequency, and stress incontinence (p < 0.05). The subset of patients receiving subcutaneous testosterone also experienced improvements in hot flashes and mood swings. An inherited variant (rs7984870 CC genotype) in TNFSF11 was more likely to be associated with improvements in hot flashes in patients receiving testosterone.
CONCLUSION
The doses of testosterone supplementation used in this study did not significantly improve AIMSS.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01573442.",2020,"Patients receiving testosterone did report improvements in strength, lack of energy, urinary frequency, and stress incontinence (p < 0.05).","['27 single nucleotide polymorphisms (SNPs) in 14 genes previously associated with AIMSS were associated with testosterone supplementation benefit', 'Postmenopausal women experiencing moderate-to-severe arthralgias while taking adjuvant aromatase inhibitors for breast cancer', 'patients receiving testosterone', 'postmenopausal women with aromatase inhibitor-induced arthralgias']","['testosterone', 'subcutaneous testosterone pellet versus a placebo pellet', 'subcutaneous testosterone', 'topical testosterone gel or a placebo gel', 'testosterone supplementation', 'placebo']","['hot flashes', 'hot flashes and other vasomotor symptoms', 'hot flashes and mood swings', 'average pain or joint stiffness', 'joint pain', 'strength, lack of energy, urinary frequency, and stress incontinence', 'AIMSS']","[{'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0231443', 'cui_str': 'Musculoskeletal symptom'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0441436', 'cui_str': 'Pellet gun missile'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3219108', 'cui_str': 'Testosterone-containing product in transdermal dose form'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0162298', 'cui_str': 'Joint stiffness'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0231443', 'cui_str': 'Musculoskeletal symptom'}]",,0.674333,"Patients receiving testosterone did report improvements in strength, lack of energy, urinary frequency, and stress incontinence (p < 0.05).","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cathcart-Rake', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novotny', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Leon-Ferre', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Le-Rademacher', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Storrick', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Araba A', 'Initials': 'AA', 'LastName': 'Adjei', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Terstriep', 'Affiliation': 'Sanford NCORP of the North Central Plains, Sioux Falls, SD, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Glaser', 'Affiliation': 'Wright State University Boonshoft School of Medicine, Dayton, OH, USA.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Giuliano', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Mitchell', 'Affiliation': 'Southeast Clinical Oncology Research Consortium NCORP, Winston-Salem, NC, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Page', 'Affiliation': 'Wichita NCI Community Oncology Research Program, Wichita, KS, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Austin', 'Affiliation': 'Northside Hospital, Atlanta, GA, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Deming', 'Affiliation': 'Mercy Medical Center, Des Moines, IA, USA.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Ferreira', 'Affiliation': 'Northside Hospital, Atlanta, GA, USA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Lafky', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Stephen N', 'Initials': 'SN', 'LastName': 'Birrell', 'Affiliation': 'The Breast and Endocrine Centre, Toorak Gardens, South Australia, Australia.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Loprinzi', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA. cloprinzi@mayo.edu.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05473-2']
48,32380954,Correlation and variation of cuff inflating volumes and pressures in different adult models of laryngeal mask: a prospective randomized trial.,"BACKGROUND
Hyperinflation of laryngeal mask cuffs may carry the risk of airway complications. The manufacturer recommends inflating cuff until the intracuff pressure reaches 60 cmH 2 O, or inflate with the volume of air to not exceed the maximum recommended volume. We prospectively assessed the correlation of cuff inflating volumes and pressures, and the appropriated the cuff inflating volumes to generate an intracuff pressure of 60 cmH 2 O in the adult laryngeal masks from different manufacturers.
METHODS
Two groups of 80 patients requiring laryngeal mask size 3 and 4 during general anesthesia were randomized into 4 subgroups for each size of the laryngeal mask: Soft Seal® (Portex®), AuraOnce™ (Ambu®), LMA-Classic™ (Teleflex®) and LMA-ProSeal™ (Teleflex®). After insertion, the cuff was inflated with 5-ml increments of air up to the maximum recommended volume. After each 5-ml intracuff pressure was measured, the volume of air that generated the intracuff pressure of 60 cmH 2 O was recorded.
RESULTS
Mean (SD) volume of air required to achieve the intracuff pressure of 60 cmH 2 O in Soft Seal®, AuraOnce™, LMA-Classic™, LMA-ProSeal™ laryngeal mask size 3 were 11.80(1.88), 9.20(1.88), 8.95(1.50) and 13.50(2.48) ml, respectively, and these volumes in laryngeal mask size 4 were 14.45(4.12), 12.55(1.85), 11.30(1.95) and 18.20(3.47) ml, respectively. The maximum recommended volume resulted in high intracuff pressures (> 60 cmH 2 O) in all laryngeal mask types and sizes studied.
CONCLUSION
Pressure-volume curves of adult laryngeal masks are all in sigmoidal shape. Cuff designs and materials can effect pressure and volume correlation. Approximately half of the maximum recommended volume is required to achieve the intracuff pressure of 60 cmH 2 O except LMA-ProSeal™ which required two-thirds of the maximum recommended volume.
TRIAL REGISTRATION
Thai Clinical Trials Registry, TCTR20150602001, May 28, 2015.",2020,"The maximum recommended volume resulted in high intracuff pressures (> 60 cmH 2 O) in all laryngeal mask types and sizes studied.
CONCLUSION
Pressure-volume curves of adult laryngeal masks are all in sigmoidal shape.","['different adult models of laryngeal mask', 'Two groups of 80 patients requiring laryngeal mask size 3 and 4 during general anesthesia']","['laryngeal mask: Soft Seal® (Portex®), AuraOnce™ (Ambu®), LMA-Classic™ (Teleflex®) and LMA-ProSeal™ (Teleflex®']",['Mean (SD) volume of air required to achieve the intracuff pressure'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0439658', 'cui_str': 'Classic'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",,0.0560544,"The maximum recommended volume resulted in high intracuff pressures (> 60 cmH 2 O) in all laryngeal mask types and sizes studied.
CONCLUSION
Pressure-volume curves of adult laryngeal masks are all in sigmoidal shape.","[{'ForeName': 'Narut', 'Initials': 'N', 'LastName': 'Ruananukun', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Rajchathewi, Bangkok, 10400, Thailand. aek_narut@hotmail.com.'}, {'ForeName': 'Jittiya', 'Initials': 'J', 'LastName': 'Watcharotayangul', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Rajchathewi, Bangkok, 10400, Thailand.'}, {'ForeName': 'Suchaya', 'Initials': 'S', 'LastName': 'Jeeranukosol', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Rajchathewi, Bangkok, 10400, Thailand.'}, {'ForeName': 'Rojnarin', 'Initials': 'R', 'LastName': 'Komonhirun', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Rajchathewi, Bangkok, 10400, Thailand.'}]",BMC anesthesiology,['10.1186/s12871-020-01028-4']
49,32323429,Evaluating the efficacy of ursodeoxycholic acid plus methotrexate vs methotrexate alone in the treatment of moderate to severe plaque-type psoriasis: A randomized clinical trial.,,2020,,['moderate to severe plaque-type psoriasis'],['Ursodeoxycholic acid plus Methotrexate versus Methotrexate alone'],[],"[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]",[],,0.0291496,,"[{'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Lajevardi', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amine', 'Initials': 'A', 'LastName': 'Kashiri', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghiasi', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Darya', 'Initials': 'D', 'LastName': 'Khosravi', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Fazlolahi', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ifa', 'Initials': 'I', 'LastName': 'Etesami', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Dermatologic therapy,['10.1111/dth.13455']
50,32390309,"A retrospective assessment and comparison of the effectiveness of benzoyl peroxide; the combination of topical niacinamide, gallic acid, and lauric acid; and the combination of benzoyl peroxide and erythromycin in acne vulgaris.","Acne vulgaris is a chronic inflammatory skin disease that mostly develops during adolescence and continues throughout adulthood. It affects the face, the main location of cosmetic appearance. Despite many developments in acne treatment, various combination therapies are needed to create the best option. Ninety patients were included in this study. We used the global acne grading system (GAGS) and the lesion counting and photographic standards that were used by Hayashi et al., to assess acne severity. The patients were randomly divided into three groups as group 1 (using only 5% BPO, twice a day), group 2 (using only the combination of 5% BPO + 3% erythromycin, twice a day), and group 3 (using only the combination of 4% niacinamide + 1% gallic acid + 1% lauric acid, twice a day). Thirty patients were included in each group. The scores were evaluated at weeks 0, 2, 4 and 8, and compared with each other. As a result of the study, all three treatment types were found to be effective. The combination of 4% niacinamide + 1% gallic acid + 1% lauric acid can be used as an alternative topical treatment for acne vulgaris to prevent resistance against topical antibiotics and the side effects of some other treatments.",2020,"As a result of the study, all three treatment types were found to be effective.","['30 patients were included in each group', 'Ninety patients were included in this study', 'acne vulgaris']","['benzoyl peroxide', 'BPO\u2009+\u20093% erythromycin, twice a day) and Group 3 (using only the combination of 4% niacinamide +1% gallic acid +1% lauric acid', 'niacinamide +1% gallic acid +1% lauric acid', 'topical niacinamide, gallic acid and lauric acid and the combination of benzoyl peroxide and erythromycin']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]","[{'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0016979', 'cui_str': 'Gallic acid'}, {'cui': 'C0023139', 'cui_str': 'Lauric acid'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]",[],90.0,0.0201762,"As a result of the study, all three treatment types were found to be effective.","[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Kozan', 'Affiliation': 'Amasya University Sabuncuoglu Serefeddin Training and Research Hospital-Dermatology, Amasya, Turkey.'}, {'ForeName': 'Rukiye Yasak', 'Initials': 'RY', 'LastName': 'Guner', 'Affiliation': 'Dermatology Department, Cumhuriyet University School of Medicine, Sivas, Turkey.'}, {'ForeName': 'Melih', 'Initials': 'M', 'LastName': 'Akyol', 'Affiliation': 'Dermatology Department, Cumhuriyet University School of Medicine, Sivas, Turkey.'}]",Dermatologic therapy,['10.1111/dth.13534']
51,32326969,Raising awareness of antimicrobial resistance: comment on 'Reducing expectations for antibiotics in primary care: a randomised experiment to test the response to fear based messages about antimicrobial resistance'.,,2020,,['primary care'],[],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],[],,0.0255156,,"[{'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'AMR Clinical Reference Center, National Center for Global Health and Medicine Hospital, Tokyo, Japan. yogu@hosp.ncgm.go.jp.'}]",BMC medicine,['10.1186/s12916-020-01576-z']
52,32393245,Using alcohol consumption diary data from an internet intervention for outcome and predictive modeling: a validation and machine learning study.,"BACKGROUND
Alcohol use disorder (AUD) is highly prevalent and presents a large treatment gap. Self-help internet interventions are an attractive approach to lowering thresholds for seeking help and disseminating evidence-based programs at scale. Internet interventions for AUD however suffer from high attrition and since continuous outcome measurements are uncommon, little is known about trajectories and processes. The current study investigates whether data from a non-mandatory alcohol consumption diary, common in internet interventions for AUD, approximates drinks reported at follow-up, and whether data from the first half of the intervention predict treatment success.
METHODS
N = 607 participants enrolled in a trial of online self-help for AUD, made an entry in the non-mandatory consumption diary (total of 9117 entries), and completed the follow-up assessment. Using multiple regression and a subset of calendar data overlapping with the follow-up, scaling factors were derived to account for missing entries per participant and week. Generalized estimating equations with an inverse time predictor were then used to calculate point-estimates of drinks per week at follow-up, the confidence intervals of which were compared to that from the measurement at follow-up. Next, calendar data form the first half of the intervention were retained and summary functions used to create 18 predictors for random forest machine learning models, the classification accuracies of which were ultimately estimated using nested cross-validation.
RESULTS
While the raw calendar data substantially underestimated drinks reported at follow-up, the confidence interval of the trajectory-derived point-estimate from the adjusted data overlapped with the confidence interval of drinks reported at follow-up. Machine learning models achieved prediction accuracies of 64% (predicting non-hazardous drinking) and 48% (predicting AUD severity decrease), in both cases with higher sensitivity than specificity.
CONCLUSIONS
Data from a non-mandatory alcohol consumption diary, adjusted for missing entries, approximates follow-up data at a group level, suggesting that such data can be used to reveal trajectories and processes during treatment and possibly be used to impute missing follow-up data. At an individual level, however, calendar data from the first half of the intervention did not have high predictive accuracy, presumable due to a high rate of missing data and unclear missing mechanisms.",2020,"Machine learning models achieved prediction accuracies of 64% (predicting non-hazardous drinking) and 48% (predicting AUD severity decrease), in both cases with higher sensitivity than specificity.
","['N\xa0', '607 participants enrolled in a trial of online self-help for AUD, made an entry in the non-mandatory consumption diary (total of 9117 entries), and completed the follow-up assessment']",['Self-help internet interventions'],['prediction accuracies'],"[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}]",607.0,0.047745,"Machine learning models achieved prediction accuracies of 64% (predicting non-hazardous drinking) and 48% (predicting AUD severity decrease), in both cases with higher sensitivity than specificity.
","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Lindner', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden. philip.lindner@ki.se.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Johansson', 'Affiliation': 'Center for Dependency Disorders, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Gajecki', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Berman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}]",BMC medical research methodology,['10.1186/s12874-020-00995-z']
53,32359348,Comparison of ED95 of Butorphanol and Sufentanil for gastrointestinal endoscopy sedation: a randomized controlled trial.,"BACKGROUND
Butorphanol, a synthetic opioid partial agonist analgesic, has been widely used to control perioperative pain. However, the ideal dose and availability of butorphanol for gastrointestinal (GI) endoscopy are not well known. The aim of this study was to evaluated the 95% effective dose (ED 95 ) of butorphanol and sufentanil in GI endoscopy and compared their clinical efficacy, especially regarding the recovery time.
METHODS
The study was divided into two parts. For the first part, voluntary patients who needed GI endoscopy anesthesia were recruited to measure the ED 95 of butorphanol and sufentanil needed to achieve successful sedation before GI endoscopy using the sequential method (the Dixon up-and-down method). The second part was a double-blind, randomized study. Two hundred cases of painless GI endoscopy patients were randomly divided into two groups (n = 100), including group B (butorphanol at the ED 95 dose) and group S (sufentanil at the ED 95 dose). Propofol was infused intravenously as the sedative in both groups. The recovery time, visual analogue scale (VAS) score, hand grip strength, fatigue severity scores, incidence of nausea and vomiting, and incidence of dizziness were recorded.
RESULTS
The ED 95 of butorphanol for painless GI endoscopy was 9.07 μg/kg (95% confidence interval: 7.81-19.66 μg/kg). The ED 95 of sufentanil was 0.1 μg/kg (95% CI, 0.079-0.422 μg/kg). Both butorphanol and sufentanil provided a good analgesic effect for GI endoscopy. However, the recovery time for butorphanol was significantly shorter than that for sufentanil (P < 0.05, group B vs. group S:21.26 ± 7.70 vs. 24.03 ± 7.80 min).
CONCLUSIONS
Butorphanol at 9.07 μg/kg was more effective than sufentanil for GI endoscopy sedation and notably reduced the recovery time.
TRIAL REGISTRATION
Chinese Clinical Trail Registry (Registration number # ChiCTR1900022780; Date of Registration on April 25rd, 2019).",2020,"The recovery time, visual analogue scale (VAS) score, hand grip strength, fatigue severity scores, incidence of nausea and vomiting, and incidence of dizziness were recorded.
","['Two hundred cases of painless', 'voluntary patients who needed GI endoscopy anesthesia', 'GI endoscopy patients', 'gastrointestinal endoscopy sedation']","['butorphanol', 'butorphanol and sufentanil', 'Butorphanol', 'ED95 of Butorphanol and Sufentanil', 'sufentanil', 'group B (butorphanol at the ED 95 dose) and group S (sufentanil', 'Propofol']","['recovery time', 'recovery time, visual analogue scale (VAS) score, hand grip strength, fatigue severity scores, incidence of nausea and vomiting, and incidence of dizziness', 'recovery time for butorphanol', 'GI endoscopy']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0580276', 'cui_str': 'Informal patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0079278', 'cui_str': 'Gastrointestinal tract endoscopy'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0079278', 'cui_str': 'Gastrointestinal tract endoscopy'}]",,0.25203,"The recovery time, visual analogue scale (VAS) score, hand grip strength, fatigue severity scores, incidence of nausea and vomiting, and incidence of dizziness were recorded.
","[{'ForeName': 'Xiaona', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital, Wenzhou Medical University, Shangcai village, Nanbaixiang town, Ouhai District, Wenzhou City, 325000, Zhejiang Province, China.'}, {'ForeName': 'Limei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital, Wenzhou Medical University, Shangcai village, Nanbaixiang town, Ouhai District, Wenzhou City, 325000, Zhejiang Province, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital, Wenzhou Medical University, Shangcai village, Nanbaixiang town, Ouhai District, Wenzhou City, 325000, Zhejiang Province, China.'}, {'ForeName': 'Linmin', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital, Wenzhou Medical University, Shangcai village, Nanbaixiang town, Ouhai District, Wenzhou City, 325000, Zhejiang Province, China. panlinmina@163.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01027-5']
54,32359367,"Intraoperative dexmedetomidine attenuates norepinephrine levels in patients undergoing transsphenoidal surgery: a randomized, placebo-controlled trial.","BACKGROUND
Dexmedetomidine has sympatholytic effects. We investigated whether dexmedetomidine could attenuate stress responses in patients undergoing endoscopic transnasal transseptal transsphenoidal surgery.
METHODS
Forty-six patients were randomized to receive a continuous infusion of 0.9% saline (n = 23) or dexmedetomidine (n = 23). Immediately after general anesthesia induction, the dexmedetomidine group received a loading dose of 1 mcg/kg dexmedetomidine over 10 min, followed by a maintenance dose of 0.2-0.7 mcg/kg/h and the control group received 0.9% saline at the same volume until 30 min before the end of surgery. Serum levels of epinephrine, norepinephrine, and glucose were assessed before surgery (T1) and the end of drug infusion (T2). The primary outcome was the change in norepinephrine levels between the two time points.
RESULTS
Changes (T2-T1 values) in perioperative serum norepinephrine levels were significantly greater in the dexmedetomidine group than in the control group (median difference, 56.9 pg/dL; 95% confidence interval, 20.7 to 83.8 pg/dL; P = 0.002). However, epinephrine level changes did not show significant intergroup differences (P = 0.208). Significantly fewer patients in the dexmedetomidine group than in the control group required rescue analgesics at the recovery area (4.3% vs. 30.4%, P = 0.047).
CONCLUSIONS
Intraoperative dexmedetomidine administration reduced norepinephrine release and rescue analgesic requirement. Dexmedetomidine might be used as an anesthetic adjuvant in patients undergoing transnasal transseptal transsphenoidal surgery.
TRIAL REGISTRATION
Clinical Trial Registry of Korea, identifier: KCT0003366; registration date: 21/11/2018; presenting author: Ji Seon Jeong.",2020,"Significantly fewer patients in the dexmedetomidine group than in the control group required rescue analgesics at the recovery area (4.3% vs. 30.4%, P = 0.047).
","['patients undergoing transnasal transseptal transsphenoidal surgery', 'Forty-six patients', 'patients undergoing endoscopic transnasal transseptal transsphenoidal surgery', 'patients undergoing transsphenoidal surgery']","['Dexmedetomidine', 'control group received 0.9% saline', 'Intraoperative dexmedetomidine', 'continuous infusion of 0.9% saline', 'dexmedetomidine', 'placebo']","['Serum levels of epinephrine, norepinephrine, and glucose', 'change in norepinephrine levels', 'perioperative serum norepinephrine levels', 'stress responses', 'norepinephrine levels', 'norepinephrine release and rescue analgesic requirement', 'rescue analgesics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0442381', 'cui_str': 'Transseptal nasal approach'}, {'cui': 'C0205508', 'cui_str': 'Transsphenoidal approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1275471', 'cui_str': 'Serum norepinephrine measurement'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",46.0,0.659728,"Significantly fewer patients in the dexmedetomidine group than in the control group required rescue analgesics at the recovery area (4.3% vs. 30.4%, P = 0.047).
","[{'ForeName': 'RyungA', 'Initials': 'R', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon ro, Gangnam gu, Seoul, 06351, South Korea.'}, {'ForeName': 'Ji Seon', 'Initials': 'JS', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon ro, Gangnam gu, Seoul, 06351, South Korea. jiseon78.jeong@samsung.com.'}, {'ForeName': 'Justin Sangwook', 'Initials': 'JS', 'LastName': 'Ko', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon ro, Gangnam gu, Seoul, 06351, South Korea.'}, {'ForeName': 'Soo-Youn', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jong Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon ro, Gangnam gu, Seoul, 06351, South Korea.'}, {'ForeName': 'Soo Joo', 'Initials': 'SJ', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon ro, Gangnam gu, Seoul, 06351, South Korea.'}, {'ForeName': 'Sungrok', 'Initials': 'S', 'LastName': 'Cha', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon ro, Gangnam gu, Seoul, 06351, South Korea.'}, {'ForeName': 'Jeong Jin', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon ro, Gangnam gu, Seoul, 06351, South Korea.'}]",BMC anesthesiology,['10.1186/s12871-020-01025-7']
55,32371534,"A prospective, controlled study of non-motor effects of subthalamic stimulation in Parkinson's disease: results at the 36-month follow-up.","OBJECTIVE
To examine 36-month effects of bilateral subthalamic nucleus deep brain stimulation (STN-DBS) on non-motor symptoms (NMS) compared with standard-of-care medical treatment (MED) in Parkinson's disease (PD).
METHODS
Here we report the 36-month follow-up of a prospective, observational, controlled, international multicentre study of the NILS cohort. Assessments included NMSScale (NMSS), PDQuestionnaire-8 (PDQ-8), Scales for Outcomes in PD (SCOPA)-motor examination, -activities of daily living, and -complications, and levodopa equivalent daily dose (LEDD). Propensity score matching resulted in a pseudo-randomised sub-cohort balancing baseline demographic and clinical characteristics between the STN-DBS and MED groups. Within-group longitudinal outcome changes were analysed using Wilcoxon signed-rank and between-group differences of change scores with Mann-Whitney U test. Strength of clinical responses was quantified with Cohen's effect size. In addition, bivariate correlations of change scores were explored.
RESULTS
Propensity score matching applied on the cohort of 151 patients (STN-DBS n=67, MED n=84) resulted in a well-balanced sub-cohort including 38 patients per group. After 36 months, STN-DBS significantly improved NMSS, PDQ-8, SCOPA-motor examination and -complications and reduced LEDD. Significant between-group differences, all favouring STN-DBS, were found for NMSS, SCOPA-motor complications, LEDD (large effects), motor examination and PDQ-8 (moderate effects). Furthermore, significant differences were found for the sleep/fatigue, urinary (large effects) and miscellaneous NMSS domains (moderate effects). NMSS total and PDQ-8 change scores correlated significantly.
CONCLUSIONS
This study provides Class IIb evidence for beneficial effects of STN-DBS on NMS at 36-month follow-up which also correlated with quality of life improvements. This highlights the importance of NMS for DBS outcomes assessments.",2020,"After 36 months, STN-DBS significantly improved NMSS, PDQ-8, SCOPA-motor examination and -complications and reduced LEDD.","[""Parkinson's disease"", ""Parkinson's disease (PD""]","['subthalamic stimulation', 'bilateral subthalamic nucleus deep brain stimulation (STN-DBS', 'standard-of-care medical treatment (MED', 'STN-DBS']","['NMSScale (NMSS), PDQuestionnaire-8 (PDQ-8), Scales for Outcomes in PD (SCOPA)-motor examination, -activities of daily living, and -complications, and levodopa equivalent daily dose (LEDD', 'NMSS, PDQ-8, SCOPA-motor examination and -complications and reduced LEDD', 'NMSS total and PDQ-8 change scores', 'sleep/fatigue, urinary (large effects) and miscellaneous NMSS domains', 'NMSS, SCOPA-motor complications, LEDD (large effects), motor examination and PDQ-8 (moderate effects', 'quality of life improvements']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205395', 'cui_str': 'Miscellaneous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",151.0,0.0752582,"After 36 months, STN-DBS significantly improved NMSS, PDQ-8, SCOPA-motor examination and -complications and reduced LEDD.","[{'ForeName': 'Stefanie Theresa', 'Initials': 'ST', 'LastName': 'Jost', 'Affiliation': 'Department of Neurology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sauerbier', 'Affiliation': 'Department of Neurology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Visser-Vandewalle', 'Affiliation': 'Department of Stereotaxy and Functional Neurosurgery, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Keyoumars', 'Initials': 'K', 'LastName': 'Ashkan', 'Affiliation': ""Parkinson Foundation International Centre of Excellence, King's College Hospital, London, UK.""}, {'ForeName': 'Monty', 'Initials': 'M', 'LastName': 'Silverdale', 'Affiliation': 'Department of Neurology and Neurosurgery, Salford Royal NHS Foundation Trust, Manchester Academic Health Science Centre, Greater Manchester, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Evans', 'Affiliation': 'Department of Neurology and Neurosurgery, Salford Royal NHS Foundation Trust, Manchester Academic Health Science Centre, Greater Manchester, UK.'}, {'ForeName': 'Philipp A', 'Initials': 'PA', 'LastName': 'Loehrer', 'Affiliation': 'Department of Neurology, University Hospital of Giessen and Marburg, Campus Marburg, Marburg, Hessen, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Rizos', 'Affiliation': ""Parkinson Foundation International Centre of Excellence, King's College Hospital, London, UK.""}, {'ForeName': 'Jan Niklas', 'Initials': 'JN', 'LastName': 'Petry-Schmelzer', 'Affiliation': 'Department of Neurology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Reker', 'Affiliation': 'Department of Neurology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Gereon Rudolf', 'Initials': 'GR', 'LastName': 'Fink', 'Affiliation': 'Department of Neurology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Franklin', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Köln, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Samuel', 'Affiliation': ""Parkinson Foundation International Centre of Excellence, King's College Hospital, London, UK.""}, {'ForeName': 'Alfons', 'Initials': 'A', 'LastName': 'Schnitzler', 'Affiliation': 'Department of Neurology, Center for Movement Disorders and Neuromodulation, Heinrich-Heine-University Duesseldorf, Duesseldorf, Germany.'}, {'ForeName': 'Michael Thomas', 'Initials': 'MT', 'LastName': 'Barbe', 'Affiliation': 'Department of Neurology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Antonini', 'Affiliation': 'Parkinson and Movement Disorders Unit, IRCCS Hospital San Camillo, Venice, Italy.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Martinez-Martin', 'Affiliation': 'Center for Networked Biomedical Research on Neurodegenerative Diseases, Madrid, Spain.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Timmermann', 'Affiliation': 'Department of Neurology, University Hospital of Giessen and Marburg, Campus Marburg, Marburg, Hessen, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ray-Chaudhuri', 'Affiliation': ""Parkinson Foundation International Centre of Excellence, King's College Hospital, London, UK.""}, {'ForeName': 'Haidar S', 'Initials': 'HS', 'LastName': 'Dafsari', 'Affiliation': 'Department of Neurology, University Hospital Cologne, Cologne, Germany haidar.salimi-dafsari@uk-koeln.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2019-322614']
56,32379374,Clinical evaluation of the efficacy of trichloroacetic acid 70% after microneedling vs intradermal injection of 5-fluorouracil in the treatment of nonsegmental vitiligo; A prospective comparative study.,"Vitiligo is a skin disorder commonly acquired. Although different therapies are used, they are refractory to therapy in many cases. Trauma has been reported to cause hyperpigmentation by the pigment incontinence, which results in the build-up of melanophages in the upper dermis after basal cell layer destruction. To detect the effectiveness of trichloroacetic acid (TCA) 70% in the treatment of nonsegmental vitiligo after skin microneedling by dermapen or intradermal injection of 5-fluorouracil.
PATIENTS AND METHODS
A prospective comparative study was enrolled with 32 patients with vitiligo who were assigned to two equal groups. Each containing 16 patients; group 1 was treated by microneedling followed by TCA 70%, group 2 was treated by intradermal 5-FU injection. This was done every 2 weeks for 2 months.
RESULTS
According to the Physician's Global Assessment, there was no significant (P < .05) difference in the therapeutic response between the two studied groups.
CONCLUSIONS
Both microneedling plus TCA 70% and 5-FU intradermal injection are a simple means of treating vitiligo with cosmetically accepted repigmentation of all age groups, as well as a relatively safe alternative or additive method that can be used before (or in combination with) any of the well-known and widely approved method for stable nonsegmented vitiligo treatment.",2020,"According to the Physician's Global Assessment, there was no significant (P < 0.","['A prospective comparative study was enrolled with thirty- two patients with vitiligo who were assigned to two equal groups', 'non-segmental vitiligo after skin micro-needling by dermapen or intradermal injection of', 'non-segmental vitiligo']","['trichloroacetic acid (TCA', '5-FU intradermal injection', 'intradermal 5-FU injection', 'trichloroacetic acid 70% after micro-needling vs intradermal injection of 5-fluorouracil', 'micro-needling followed by TCA', '5-fluorouracil']",['therapeutic response'],"[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009491', 'cui_str': 'Comparative Studies'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1274648', 'cui_str': 'Segmental vitiligo'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}]","[{'cui': 'C0040900', 'cui_str': 'Trichloroacetic acid'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0521982', 'cui_str': 'Response to treatment'}]",32.0,0.0177793,"According to the Physician's Global Assessment, there was no significant (P < 0.","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Khater', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Nasr', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Salah', 'Affiliation': 'Dermatology Resident, Belbis Hospital, Egypt.'}, {'ForeName': 'Fathia M', 'Initials': 'FM', 'LastName': 'Khattab', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13532']
57,32379383,The impact of short sleep on food reward processes in adolescents.,"Short sleep has been linked to adolescent risk of obesity, but questions remain regarding the dietary mechanisms by which this occurs. We tested whether mildly shortening sleep influences how rewarding and appealing healthy adolescents find several kinds of foods. Eighty-eight healthy adolescents completed a within-subjects crossover sleep experiment comparing 5 days of Short Sleep (6.5 hr sleep opportunity) with 5 days of Healthy Sleep (9.5 hr sleep opportunity). Following each condition, adolescents completed measures of food appeal and reinforcing value of food across five food types: sweets/desserts, fruits/vegetables, lean meats/eggs, fast food and processed snacks. Adolescents averaged 2.2 hr/night longer sleep periods in Healthy Sleep versus Short Sleep. We observed a significant interaction of experimental order with sleep condition on three of four primary outcomes related to the appeal and reinforcing value of foods (p's < .005). When Short Sleep preceded Healthy Sleep, adolescents endorsed significantly greater appeal (p < .04) and rewarding value of food (p's ranging from <.01 to .048) during Short Sleep (compared to Healthy Sleep). However, when Healthy Sleep preceded Short Sleep, we did not observe a main effect of sleep condition on the same outcomes (p's > .05). This study provides evidence that restricting adolescents' sleep opportunity to 6.5 hr (compared to sleeping a healthy amount) increases the appeal and reinforcing value of a variety of foods, but this may occur only under protracted short sleep. Increased food reward may be one mechanism linking chronically shortened sleep with risk of obesity in adolescence.",2020,"When Short Sleep preceded Healthy Sleep, adolescents endorsed significantly greater appeal (p < .04) and rewarding value of food (p's ranging from <.01 to .048) during Short Sleep (compared to Healthy Sleep).","['Eighty-eight healthy adolescents', 'adolescents']","['food appeal and reinforcing value of food across five food types: sweets/desserts, fruits/vegetables, lean meats/eggs, fast food and processed snacks', 'Short Sleep (6.5\xa0hr sleep opportunity) with 5\xa0days of Healthy Sleep']",['appeal and reinforcing value of foods '],"[{'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449492', 'cui_str': 'Type of food'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0453505', 'cui_str': 'Dessert'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",88.0,0.0204186,"When Short Sleep preceded Healthy Sleep, adolescents endorsed significantly greater appeal (p < .04) and rewarding value of food (p's ranging from <.01 to .048) during Short Sleep (compared to Healthy Sleep).","[{'ForeName': 'Kara M', 'Initials': 'KM', 'LastName': 'Duraccio', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Krietsch', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Nanhua', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Catharine', 'Initials': 'C', 'LastName': 'Whitacre', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Howarth', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Pfeiffer', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Dean W', 'Initials': 'DW', 'LastName': 'Beebe', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}]",Journal of sleep research,['10.1111/jsr.13054']
58,32379638,Can Qigong improve non-motor symptoms in people with Parkinson's disease - A pilot randomized controlled trial?,"Non-motor symptoms (NMS) including sleep disorders, anxiety, depression, fatigue, and cognitive decline can significantly impact quality of life in people with PD. Qigong exercise is a mind-body exercise that shows a wide range of benefits in various medical conditions. The purpose of this study was to investigate the effect of Qigong exercise on NMS with a focus on sleep quality. Seventeen participants completed a 12-week intervention of Qigong (n = 8) or sham Qigong (n = 9). Disease severity, anxiety and depression levels, fatigue, cognition, quality of life, and other NMS of the participants were evaluated prior to the intervention and at the end of the 12-week intervention. After the intervention, both Qigong and sham-Qigong group showed significant improvement in sleep quality (p < 0.05) and overall NMS (p < 0.05). No significant difference was found between groups. Qigong exercise has the potential as a rehabilitation method for people with PD, specifically alleviating NMS in PD. However, this finding needs to be carefully considered due to the small sample size and potentially low intervention fidelity of this study.",2020,"Qigong exercise has the potential as a rehabilitation method for people with PD, specifically alleviating NMS in PD.","['Seventeen participants completed a 12-week', ""people with Parkinson's disease"", 'people with PD']","['intervention of Qigong (n\xa0=\xa08) or sham', 'Can Qigong', 'Qigong exercise']","['Disease severity, anxiety and depression levels, fatigue, cognition, quality of life, and other NMS', 'overall NMS', 'sleep quality', 'sleep disorders, anxiety, depression, fatigue, and cognitive decline']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]",17.0,0.0613723,"Qigong exercise has the potential as a rehabilitation method for people with PD, specifically alleviating NMS in PD.","[{'ForeName': 'Sanghee', 'Initials': 'S', 'LastName': 'Moon', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: smoon@kumc.edu.'}, {'ForeName': 'Caio V M', 'Initials': 'CVM', 'LastName': 'Sarmento', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, USA; Department of Physical Therapy, Department of Physical Therapy, California State University, Fresno, CA, USA. Electronic address: caio@mail.fresnostate.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Steinbacher', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: msteinbacher2@kumc.edu.'}, {'ForeName': 'Irina V', 'Initials': 'IV', 'LastName': 'Smirnova', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: ismrinova@kumc.edu.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Colgrove', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: ycolgrove@kumc.edu.'}, {'ForeName': 'Sue-Min', 'Initials': 'SM', 'LastName': 'Lai', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: slai@kumc.edu.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Lyons', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: klyons@kumc.edu.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: wliu@kumc.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101169']
59,32385765,"In shoulder adhesive capsulitis, ultrasound-guided anterior hydrodilatation in rotator interval is more effective than posterior approach: a randomized controlled study.","Shoulder adhesive capsulitis, also called frozen shoulder, is a musculoskeletal disorder associated with pain and functional disability. This study aimed to compare the effectiveness of shoulder ultrasound-guided hydrodilatation with corticosteroid, via rotator interval (RI) anteriorly, versus posterior approach, in adhesive capsulitis patients. All patients received exercise program following injection.
PATIENTS AND METHODS
A prospective randomized controlled study among 60 consecutive adhesive capsulitis patients was randomized into two equal groups. Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach; group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach. Both groups received guided stretching exercises for 3 months after injection. Baseline and 3 months evaluation of pain by visual analogue scale (VAS), shoulder pain and disability index (SPADI), and range of motion (ROM) had been recorded for all patients.
RESULTS
Both groups showed significant improvement 3 months after hydrodilatation regarding VAS pain, external rotation, and SPADI. Only in group II (RI anterior approach) improvement was observed regarding flexion and abduction. There was no improvement regarding extension or internal rotation in either group. When comparing the improvement in both groups after hydrodilatation, group II (anterior approach) showed a statistically significant higher level of improvement regarding VAS pain (p = 0.003), SPADI, flexion, abduction, and external rotation, compared to group I (p < 0.001). Extension, internal rotation, and adduction were not different.
CONCLUSIONS
Ultrasound-guided anterior rotator interval hydrodilatation for adhesive capsulitis, followed by guided exercise, is clinically and functionally more effective than the conventional posterior approach.",2020,There was no improvement regarding extension or internal rotation in either group.,"['60 consecutive adhesive capsulitis patients', 'adhesive capsulitis patients']","['guided stretching exercises', 'exercise program following injection', 'ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach; group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach', 'shoulder ultrasound-guided hydrodilatation with corticosteroid, via rotator interval (RI) anteriorly, versus posterior approach']","['SPADI, flexion, abduction, and external rotation', 'flexion and abduction', 'VAS pain, external rotation, and SPADI', 'pain by visual analogue scale (VAS), shoulder pain and disability index (SPADI), and range of motion (ROM', 'Extension, internal rotation, and adduction', 'extension or internal rotation', 'VAS pain']","[{'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}]",60.0,0.0893016,There was no improvement regarding extension or internal rotation in either group.,"[{'ForeName': 'Basant', 'Initials': 'B', 'LastName': 'Elnady', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Elsayed M', 'Initials': 'EM', 'LastName': 'Rageh', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Manal Shawky', 'Initials': 'MS', 'LastName': 'Hussein', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohammed Hassan', 'Initials': 'MH', 'LastName': 'Abu-Zaid', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Dalia El-Sayed', 'Initials': 'DE', 'LastName': 'Desouky', 'Affiliation': 'Department of public health and community medicine, Menoufia University, Shibin Al Kawm, Egypt.'}, {'ForeName': 'Tohamy', 'Initials': 'T', 'LastName': 'Ekhouly', 'Affiliation': 'Department of Radiology, Benha University, Benha, Egypt.'}, {'ForeName': 'Johannes J', 'Initials': 'JJ', 'LastName': 'Rasker', 'Affiliation': 'Faculty of Behavioral, Management and Social sciences, Department Psychology, Health and Technology, University of Twente, PO box 217, 7500 AE, Enschede, Netherlands. j.j.rasker@utwente.nl.'}]",Clinical rheumatology,['10.1007/s10067-020-05131-2']
60,32390102,"Yes, I can - maybe … Effects of placebo-related instructions on neuroregulation in children with ADHD.","Neurofeedback training (NFT) provides strategies for children with ADHD to achieve changes on the neurophysiological and behavioral level to attenuate ADHD symptoms. We assume self-efficacy (an ""active attitude""), a core variable in successful NFT. In a randomized, double-blind controlled study, we investigated the impact of a ""placebo instruction"" on the EEG-regulation performance during two sessions of Theta-Beta-NFT in children with ADHD (age 8-12 years). Children receiving the information ""this might be a placebo-training"" showed inferior neuroregulation (n = 10) compared to children receiving a standard instruction (n = 12). Results of our pilot study are discussed in view of factors necessary for a valid training (ensuring maximal self-efficacy in the participants) and the fidelity of placebo-controlled trials in NFT-research.",2020,"Children receiving the information ""this might be a placebo-training"" showed inferior neuroregulation (n = 10) compared to children receiving a standard instruction (n = 12).","['children with ADHD', 'children with ADHD (age 8-12\xa0years']","['Theta-Beta-NFT', 'standard instruction', 'placebo instruction', 'Neurofeedback training (NFT', 'placebo-related instructions']",['EEG-regulation performance'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",,0.224866,"Children receiving the information ""this might be a placebo-training"" showed inferior neuroregulation (n = 10) compared to children receiving a standard instruction (n = 12).","[{'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Gevensleben', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Göttingen, von-Siebold-Str. 5, D37075, Goettingen, Germany. hgevens@gwdg.de.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schmiedeke', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Göttingen, von-Siebold-Str. 5, D37075, Goettingen, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Heinrich', 'Affiliation': 'NeuroCare Group, Munich, Germany.'}, {'ForeName': 'Aribert', 'Initials': 'A', 'LastName': 'Rothenberger', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Göttingen, von-Siebold-Str. 5, D37075, Goettingen, Germany.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-020-02193-z']
61,31823292,Free-Spins Spur Gamblers to Quit EGMs Early: An Online EGM Study.,"Free-spins on slot machines introduce a salient moment of potentially large wins that might influence people to either quit or continue a gambling session. Two theoretical models make different predictions about why people quit a gambling session. From a behaviourist perspective, people quit a session when they are either satiated or the lack of rewards lead to the extinction of behaviour. Alternatively, from a behavioural-finance perspective, people quit due to the disposition effect: a general finding whereby investors tend to sell shares or other assets when the price has increased, but keep assets that have dropped in value. From the behaviourist perspective, we predict that people experience free spins as a moment of intermittent reinforcement, which should encourage them to continue gambling longer. According to the disposition effect, however, the large win would trigger risk-aversion, signalling an opportunity to ""cash out"" and lock-in the gain. In the present study, 188 gamblers (72 female) were randomly allocated to one of three conditions: control, early free-spins and late free-spins, in an online EGM simulation (points only). Consistent with the disposition effect, participants who received early free-spins quit earlier, placing significantly fewer bets, than those in control condition. The study suggests that free-spins, rather than being reinforcing within session, may signal an opportunity to quit early. In the discussion, however, we speculate on whether future research could demonstrate that a perceived lack of free spins in a session may keep players engaged longer.",2020,"Consistent with the disposition effect, participants who received early free-spins quit earlier, placing significantly fewer bets, than those in control condition.",['188 gamblers (72 female'],"['control, early free-spins and late free-spins, in an online EGM simulation', 'Quit EGMs']",[],"[{'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",[],188.0,0.0343463,"Consistent with the disposition effect, participants who received early free-spins quit earlier, placing significantly fewer bets, than those in control condition.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Rockloff', 'Affiliation': 'Central Queensland University, Bundaberg, Australia. m.rockloff@cqu.edu.au.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Stuart', 'Affiliation': 'Central Queensland University, Bundaberg, Australia.'}, {'ForeName': 'Hyoun S', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'University of Calgary, Calgary, Canada.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hodgins', 'Affiliation': 'University of Calgary, Calgary, Canada.'}]",Journal of gambling studies,['10.1007/s10899-019-09925-1']
62,32375773,"The effect of written information and counselling by an advanced practice nurse on resilience in women with vulvar neoplasia six months after surgical treatment and the influence of social support, recurrence, and age: a secondary analysis of a multicenter randomized controlled trial, WOMAN-PRO II.","BACKGROUND
Women with vulvar neoplasia often complain about physical and psychological distress after surgical treatment. Lack of information and support can influence resilience. Whether an information-related intervention through an advanced practice nurse supports resilience and which other factors affect resilience in women with vulvar neoplasia has never been investigated.
METHODS
The aims of this study were (a) to analyse whether counselling based on the WOMAN-PRO II program causes a significant improvement in the resilience scores of women with vulvar neoplasia compared to written information and (b) to identify the potential predictors of resilience. A randomized controlled trial was conducted in women with vulvar neoplasia (n = 49) 6 months after surgical treatment in four Swiss hospitals and one Austrian hospital. Analyses of resilience and its predictors were performed using a linear mixed model.
RESULTS
Thirty-six women (intervention I, n = 8; intervention II, n = 28) completed the randomized controlled trial. In total, 13 women (26.5%) dropped out of the trial. The resilience score did not differ significantly between the two interventions three and six months after randomisation (p = 0.759). Age (b = .04, p = 0.001), social support (b = .28, p = 0.009), counselling time (b = .03, p = 0.018) and local recurrence (b = -.56, p = 0.009) were identified as significant predictors of resilience in the linear mixed model analyses.
CONCLUSION
The results indicate that the WOMAN-PRO II program as single intervention does not cause a significant change in the resilience scores of women with vulvar neoplasia 6 months after surgery. Predictors that promote or minimise resilience have been identified and should be considered when developing resilience programs for women with vulvar neoplasia. A repetition of the study with a larger sample size is recommended.
TRIAL REGISTRATION
The WOMAN-PRO II program was registered in ClinicalTrials.gov NCT01986725 on 18 November 2013.",2020,The results indicate that the WOMAN-PRO II program as single intervention does not cause a significant change in the resilience scores of women with vulvar neoplasia 6 months after surgery.,"['women with vulvar neoplasia (n\u2009=\u200949) 6 months after surgical treatment in four Swiss hospitals and one Austrian hospital', 'Age ', 'women with vulvar neoplasia six months after surgical treatment', 'Thirty-six women (intervention', 'women with vulvar neoplasia', '13 women (26.5%) dropped out of the trial', 'Women with vulvar neoplasia often complain about physical and psychological distress after surgical treatment']",['written information and counselling by an advanced practice nurse'],"['local recurrence', 'resilience score', 'counselling time', 'social support', 'resilience scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0337795', 'cui_str': 'Austrians'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",13.0,0.105192,The results indicate that the WOMAN-PRO II program as single intervention does not cause a significant change in the resilience scores of women with vulvar neoplasia 6 months after surgery.,"[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Kofler', 'Affiliation': 'Institute for Applied Nursing Sciences IPW-FHS, FHS St. Gallen, University of Applied Sciences, Rosenbergstrasse 59, 9001, St. Gallen, Switzerland. sa.kofler@gmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kobleder', 'Affiliation': 'Institute for Applied Nursing Sciences IPW-FHS, FHS St. Gallen, University of Applied Sciences, Rosenbergstrasse 59, 9001, St. Gallen, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ott', 'Affiliation': 'Lecturer for Business Mathematics and Statistics, University of Applied Sciences FHS St. Gallen, Rosenbergstrasse 59, 9001, St. Gallen, Switzerland.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Senn', 'Affiliation': 'Institute for Applied Nursing Sciences IPW-FHS, FHS St. Gallen, University of Applied Sciences, Rosenbergstrasse 59, 9001, St. Gallen, Switzerland.'}]",BMC women's health,['10.1186/s12905-020-00965-z']
63,32378273,"Effects of a cream containing madecassoside, 5% panthenol, and copper-zinc-manganese on improving postlaser resurfacing wound healing: A split-face, randomized trial.",,2020,,['post-laser resurfacing wound healing'],"['cream containing madecassoside, 5% panthenol, and copper-zinc-manganese']",[],"[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0297253', 'cui_str': 'madecassoside'}, {'cui': 'C1321598', 'cui_str': 'Panthenol'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0024706', 'cui_str': 'Manganese'}]",[],,0.0411193,,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': ""L'Oreal (China) Co., Ltd., Shanghai, China.""}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Caixia', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Congying', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Zongzhou', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}]",Dermatologic therapy,['10.1111/dth.13533']
64,32380460,Pilot Randomized Trial of a Transdisciplinary Geriatric and Palliative Care Intervention for Older Adults With Cancer.,"BACKGROUND
Oncologists often struggle with managing the unique care needs of older adults with cancer. This study sought to determine the feasibility of delivering a transdisciplinary intervention targeting the geriatric-specific (physical function and comorbidity) and palliative care (symptoms and prognostic understanding) needs of older adults with advanced cancer.
METHODS
Patients aged ≥65 years with incurable gastrointestinal or lung cancer were randomly assigned to a transdisciplinary intervention or usual care. Those in the intervention arm received 2 visits with a geriatrician, who addressed patients' palliative care needs and conducted a geriatric assessment. We predefined the intervention as feasible if >70% of eligible patients enrolled in the study and >75% of eligible patients completed study visits and surveys. At baseline and week 12, we assessed patients' quality of life (QoL), symptoms, and communication confidence. We calculated mean change scores in outcomes and estimated intervention effect sizes (ES; Cohen's d) for changes from baseline to week 12, with 0.2 indicating a small effect, 0.5 a medium effect, and 0.8 a large effect.
RESULTS
From February 2017 through June 2018, we randomized 62 patients (55.9% enrollment rate [most common reason for refusal was feeling too ill]; median age, 72.3 years; cancer types: 56.5% gastrointestinal, 43.5% lung). Among intervention patients, 82.1% attended the first visit and 79.6% attended both. Overall, 89.7% completed all study surveys. Compared with usual care, intervention patients had less QoL decrement (-0.77 vs -3.84; ES = 0.21), reduced number of moderate/severe symptoms (-0.69 vs +1.04; ES = 0.58), and improved communication confidence (+1.06 vs -0.80; ES = 0.38).
CONCLUSIONS
In this pilot trial, enrollment exceeded 55%, and >75% of enrollees completed all study visits and surveys. The transdisciplinary intervention targeting older patients' unique care needs showed encouraging ES estimates for enhancing patients' QoL, symptom burden, and communication confidence.",2020,"Compared with usual care, intervention patients had less QoL decrement (-0.77 vs -3.84; ES = 0.21), reduced number of moderate/severe symptoms (-0.69 vs +1.04; ES = 0.58), and improved communication confidence (+1.06 vs -0.80; ES = 0.38).
","['Older Adults With Cancer', '62 patients (55.9% enrollment rate [most common reason for refusal was feeling too ill]; median age, 72.3 years; cancer types: 56.5% gastrointestinal, 43.5% lung', 'Patients aged ≥65 years with incurable gastrointestinal or lung cancer', 'eligible patients enrolled in the study and >75% of eligible patients completed study visits and surveys', 'older adults with cancer', 'From February 2017 through June 2018', 'older adults with advanced cancer']","['Transdisciplinary Geriatric and Palliative Care Intervention', 'transdisciplinary intervention', 'transdisciplinary intervention or usual care']","['QoL decrement', 'reduced number of moderate/severe symptoms', ""patients' quality of life (QoL), symptoms, and communication confidence"", 'communication confidence']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",62.0,0.108189,"Compared with usual care, intervention patients had less QoL decrement (-0.77 vs -3.84; ES = 0.21), reduced number of moderate/severe symptoms (-0.69 vs +1.04; ES = 0.58), and improved communication confidence (+1.06 vs -0.80; ES = 0.38).
","[{'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Nipp', 'Affiliation': '1Department of Medicine, Division of Hematology and Oncology, and.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Temel', 'Affiliation': '1Department of Medicine, Division of Hematology and Oncology, and.'}, {'ForeName': 'Charn-Xin', 'Initials': 'CX', 'LastName': 'Fuh', 'Affiliation': '1Department of Medicine, Division of Hematology and Oncology, and.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kay', 'Affiliation': '1Department of Medicine, Division of Hematology and Oncology, and.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Landay', 'Affiliation': '1Department of Medicine, Division of Hematology and Oncology, and.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lage', 'Affiliation': '1Department of Medicine, Division of Hematology and Oncology, and.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Franco-Garcia', 'Affiliation': '2Department of Medicine, Division of Palliative Care and Geriatric Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Scott', 'Affiliation': '2Department of Medicine, Division of Palliative Care and Geriatric Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Stevens', 'Affiliation': '2Department of Medicine, Division of Palliative Care and Geriatric Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Terrence', 'Initials': 'T', 'LastName': ""O'Malley"", 'Affiliation': '2Department of Medicine, Division of Palliative Care and Geriatric Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Mohile', 'Affiliation': '4Department of Medicine, Division of Hematology and Oncology, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Dale', 'Affiliation': '5Department of Supportive Care Medicine, City of Hope National Medical Center, Duarte, California.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Traeger', 'Affiliation': '6Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts; and.'}, {'ForeName': 'Ardeshir Z', 'Initials': 'AZ', 'LastName': 'Hashmi', 'Affiliation': '7Department of Internal Medicine and Geriatrics, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Jackson', 'Affiliation': '2Department of Medicine, Division of Palliative Care and Geriatric Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': '6Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts; and.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': '1Department of Medicine, Division of Hematology and Oncology, and.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': '1Department of Medicine, Division of Hematology and Oncology, and.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2019.7386']
65,32385676,Using an HIV Self-test Kit to Test a Partner: Attitudes and Preferences Among High-Risk Populations.,"For those most at risk of contracting HIV, new strategies for preventing transmission and increasing testing are needed. As part of a multi-site, randomized, controlled trial, we explored attitudes and preferences among 272 HIV-negative men who have sex with men and HIV-negative transgender women using an HIV self-testing (HIVST) kit to test partners. Less than one quarter had previously self-tested with HIVST kits (21.7%) and few had partner-tested (4.8%). Most preferred gum swab (96%) over fingerprick tests (69%), but would prefer a blood test if it gave results for other sexually transmitted infections (STIs) (86%). Five percent reported difficulties performing the test, four percent with storage, and 26% with portability. Ninety-three percent reported likelihood of using HIVST to test partners in future, but only 3% were willing to pay the current price. Efforts to improve HIVST uptake should focus on incorporating testing for other STIs, reducing test kit size, and reducing cost.",2020,"Most preferred gum swab (96%) over fingerprick tests (69%), but would prefer a blood test if it gave results for other sexually transmitted infections (STIs) (86%).",['272 HIV-negative men who have sex with men and HIV-negative transgender women using an HIV self-testing (HIVST) kit to test partners'],[],[],"[{'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]",[],[],272.0,0.0162985,"Most preferred gum swab (96%) over fingerprick tests (69%), but would prefer a blood test if it gave results for other sexually transmitted infections (STIs) (86%).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Iribarren', 'Affiliation': 'Biobehavioral Nursing and Health Informatics, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, USA. sjiribar@uw.edu.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Alan Z', 'Initials': 'AZ', 'LastName': 'Sheinfil', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez-Rios', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Frasca', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tagliaferri Rael', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cruz Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02885-3']
66,32391156,Low-chloride- versus high-chloride-containing hypertonic solution for the treatment of subarachnoid hemorrhage-related complications: The ACETatE (A low ChloriE hyperTonic solution for brain Edema) randomized trial.,"Background
Recent reports have demonstrated that among patients with subarachnoid hemorrhage (SAH) treated with hypertonic NaCl, resultant hyperchloremia has been associated with the development of acute kidney injury (AKI). We report a trial comparing the effect of two hypertonic solutions with different chloride contents on the resultant serum chloride concentrations in SAH patients, with a primary outcome aimed at limiting chloride elevation.
Methods
A low ChloridE hyperTonic solution for brain Edema (ACETatE) trial is a single-center, double-blinded, double-dummy, randomized pilot trial comparing bolus infusions of 23.4% NaCl and 16.4% NaCl/Na-acetate for the treatment of cerebral edema in patients with SAH. Randomization occurred when patients developed hyperchloremia (serum Cl - ≥ 109 mmol/L) and required hyperosmolar treatment.
Results
We enrolled 59 patients, of which 32 developed hyperchloremia and required hyperosmolar treatment. 15 patients were randomized to the 23.4% NaCl group, and 17 patients were randomized to the 16.4% NaCl/Na-acetate group. Although serum chloride levels increased similarly in both groups, the NaCl/Acetate group showed a significantly lower Cl - load at the end of the study period (978mEq vs. 2,464mEq, p < 0.01). Secondary outcome analysis revealed a reduced rate of AKI in the Na-acetate group (53.3% in the NaCl group vs. 11.8% in the Na-acetate group, p = 0.01). Both solutions had similar effects on ICP reduction, but NaCl/Acetate treatment had a more prominent effect on immediate post-infusion Na + concentrations (increase of 2.2 ± 2.8 vs. 1.4 ± 2.6, ( p < 0.01)). Proximal tubule renal biomarkers differed in concentration between the two groups.
Conclusions
Our pilot trial showed the feasibility and safety of replacing 23.4% NaCl infusions with 16.4% NaCl/Na-acetate infusions to treat cerebral edema in patients with SAH. The degree of hyperchloremia was similar in the two groups. 16.4% NaCl/Na-acetate infusions led to lower Cl - load and AKI rates than 23.4% NaCl infusions. Further multi-center studies are needed to corroborate these results.
Trial registration
clinicaltrials.gov # NCT03204955, registered on 6/28/2017.",2020,"Secondary outcome analysis revealed a reduced rate of AKI in the Na-acetate group (53.3% in the NaCl group vs. 11.8% in the Na-acetate group, p = 0.01).","['subarachnoid hemorrhage-related complications', 'We enrolled 59 patients, of which 32 developed hyperchloremia and required hyperosmolar treatment', 'SAH patients', '15 patients were randomized to the 23.4% NaCl group, and 17 patients', 'patients with SAH', 'patients with subarachnoid hemorrhage (SAH) treated with']","['hypertonic NaCl', 'low ChloridE hyperTonic solution', 'NaCl and 16.4% NaCl/Na-acetate', 'NaCl/Na-acetate group', 'NaCl infusions with 16.4% NaCl/Na-acetate infusions', 'Low-chloride- versus high-chloride-containing hypertonic solution', 'hypertonic solutions']","['degree of hyperchloremia', 'cerebral edema', 'ICP reduction', 'serum chloride levels', 'reduced rate of AKI', 'Cl - load', 'feasibility and safety', 'immediate post-infusion Na + concentrations', 'lower Cl - load and AKI rates']","[{'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085679', 'cui_str': 'Hyperchloremia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C1959973', 'cui_str': 'Percent sodium chloride'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0860861', 'cui_str': 'Cl- decreased'}, {'cui': 'C0020554', 'cui_str': 'Hypertonic solutions'}, {'cui': 'C1959973', 'cui_str': 'Percent sodium chloride'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085679', 'cui_str': 'Hyperchloremia'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1317978', 'cui_str': 'Serum chloride measurement'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",59.0,0.317213,"Secondary outcome analysis revealed a reduced rate of AKI in the Na-acetate group (53.3% in the NaCl group vs. 11.8% in the Na-acetate group, p = 0.01).","[{'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Sadan', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Singbartl', 'Affiliation': '2Department of Critical Care Medicine, Mayo Clinic, 5777 E Mayo Blvd, Phoenix, AZ 85054 USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Kraft', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Joao McONeil', 'Initials': 'JM', 'LastName': 'Plancher', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Alexander C M', 'Initials': 'ACM', 'LastName': 'Greven', 'Affiliation': '3School of Medicine, Emory University, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Kandiah', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Cederic', 'Initials': 'C', 'LastName': 'Pimentel', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Hall', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Papangelou', 'Affiliation': '4Department of Anesthesiology, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Asbury', 'Affiliation': '5Department of Pharmacy, Emory University Hospital, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Hanfelt', 'Affiliation': '6Department of Biostatistics and Bioinformatics, Emory University, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Samuels', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}]",Journal of intensive care,['10.1186/s40560-020-00449-0']
67,32327729,Deepening responses associated with improved progression-free survival with ixazomib versus placebo as posttransplant maintenance in multiple myeloma.,"In the TOURMALINE-MM3 study, post-autologous stem cell transplantation maintenance therapy with the oral proteasome inhibitor ixazomib versus placebo significantly improved progression-free survival (PFS), with a favorable safety profile. With ixazomib versus placebo maintenance, deepening responses occurred in 139/302 (46%) versus 60/187 (32%) patients with very good partial response or partial response (VGPR/PR) at study entry (relative risk 1.41, P = 0.004), and median time to best confirmed deepened response was 19.9 versus 30.8 months (24-month rate: 54.2 versus 41.4%; hazard ratio (HR): 1.384; P = 0.0342). Median PFS in patients with VGPR/PR at study entry was 26.2 versus 18.5 months (HR: 0.636, P < 0.001) with ixazomib versus placebo; in a pooled analysis across arms, in patients with versus without deepening responses, the median PFS was not reached versus 15.9 months (HR: 0.245, P < 0.001). In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028). These analyses demonstrate the significantly higher rate of deepening responses with ixazomib versus placebo maintenance and the association between deepening response and prolonged PFS.",2020,"In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028).",[],"['placebo', 'ixazomib versus placebo', 'ixazomib']","['partial response or partial response (VGPR/PR', 'progression-free survival (PFS', '24-month PFS rate', 'median PFS', 'Median PFS', 'progression-free survival']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273711', 'cui_str': 'ixazomib'}]","[{'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C3641222', 'cui_str': 'Very good'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0931225,"In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028).","[{'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'Internal Medicine V and National Center for Tumor Diseases (NCT), University Clinic Heidelberg, Heidelberg, Germany. Hartmut.Goldschmidt@med.uni-heidelberg.de.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Hematology & Medical Oncology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Katja C', 'Initials': 'KC', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital Hôtel Dieu, University of Nantes, Nantes, France.'}, {'ForeName': 'Wee-Joo', 'Initials': 'WJ', 'LastName': 'Chng', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Mikala', 'Affiliation': 'South Pest Central Hospital, National Institute for Hematology and Infectious Diseases, Budapest, Hungary.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Seràgnoli Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Ramasamy', 'Affiliation': 'Oxford University Hospitals, NHS Foundation Trust, Oxford Myeloma Centre for Translational Research, Oxford, UK.'}, {'ForeName': 'Kaveri', 'Initials': 'K', 'LastName': 'Suryanarayan', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Teng', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Labotka', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Maria Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Hematology, Hospital Universitario de Salamanca, University Hospital of Salamanca, IBSAL, CIC, IBMCC (USAL-CSIC), Salamanca, Spain.'}]",Leukemia,['10.1038/s41375-020-0819-8']
68,32393479,"Comparison of a new versus standard removable offloading device in patients with neuropathic diabetic foot ulcers: a French national, multicentre, open-label randomized, controlled trial.","INTRODUCTION
The offloading is crucial to heal neuropathic diabetic foot ulcer (DFU). Removable offloading are the most used devices. Orthèse diabète is a new customized removable knee-high offloading device immobilizing foot and ankle joints, with some specific and innovative features that may improve offloading. We aimed to evaluate the efficiency of this device in DFU healing.
RESEARCH, DESIGN AND METHODS
The evaluation of Offloading using a new removable ORTHOsis in DIABetic foot study is a French multicenter (13 centers) randomized controlled trial with blinded end points evaluation. Adults with neuropathic DFU were randomly assigned to either Orthèse Diabète (experimental device ), or any type of conventional (usually used in France) removable offloading devices (control group). The primary outcome was the 3-month proportion of patients with fully healed DFU.
RESULTS
Among 112 randomized patients (men 78%, age 62±10 years), the primary outcome occurred in 19 (33%) participants using conventional device vs 19 (35%) Orthèse Diabète users (p=0.79). Study groups were also comparable in terms of prespecified secondary end points including occurrence of new DFU (25% vs 27% in conventional and experimental groups), ipsilateral lower-limb amputation (4% vs 10%) or infectious complications (14% vs 13%) (p>0.05 for all). Adverse events were comparable between groups, including 4 deaths unrelated to study allocation (1 sudden death, 2 ventricular arrhythmias and 1 pancreatic cancer). Adverse events believed to be related to the device were higher in the Orthèse Diabète group than in the control group (15% vs 4%). Orthèse Diabète was less frequently worn than conventional devices (46% vs 66%, p=0.04).
CONCLUSIONS
Orthèse Diabète , a new removable offloading orthosis immobilizing foot and ankle joints did not show superiority compared with conventional removable devices in neuropathic DFU healing and cannot be recommended to heal DFU.
TRIAL REGISTRATION NUMBER
NCT01956162.",2020,Adverse events believed to be related to the device were higher in the Orthèse Diabète group than in the control group (15% vs 4%). ,"['112 randomized patients (men 78%, age 62±10 years', 'Adults with neuropathic DFU', 'patients with neuropathic diabetic foot ulcers']","['new versus standard removable offloading device', 'Orthèse Diabète (experimental device ), or any type of conventional (usually used in France) removable offloading devices (control group']","['occurrence of new DFU', 'Adverse events', 'sudden death, 2 ventricular arrhythmias and 1 pancreatic cancer', '3-month proportion of patients with fully healed DFU', 'infectious complications', 'ipsilateral lower-limb amputation']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0406526', 'cui_str': 'Neuropathic ulcer of foot due to diabetes mellitus'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0237568', 'cui_str': 'Experimental device'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}]",112.0,0.174542,Adverse events believed to be related to the device were higher in the Orthèse Diabète group than in the control group (15% vs 4%). ,"[{'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Potier', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France louis.potier@gmail.com.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'François', 'Affiliation': 'Endocrinology, Diabetology and Nutrition, Centre Hospitalier Universitaire de Reims, Reims, France.'}, {'ForeName': 'Dured', 'Initials': 'D', 'LastName': 'Dardari', 'Affiliation': 'Diabetology, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, Paris, France.'}, {'ForeName': 'Marilyne', 'Initials': 'M', 'LastName': 'Feron', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Narimene', 'Initials': 'N', 'LastName': 'Belhatem', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Nobecourt-Dupuy', 'Affiliation': 'Department of Diabetology, Endocrinology and Nutrition, Centre Hospitalier Universitaire de la Réunion, Saint Denis de la Réunion, France.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Dolz', 'Affiliation': 'Endocrinology Department, Hôpital Bégin, Saint-Mandé, France.'}, {'ForeName': 'Lyse', 'Initials': 'L', 'LastName': 'Bordier', 'Affiliation': 'Endocrinology Department, Hôpital Bégin, Saint-Mandé, France.'}, {'ForeName': 'Roxane', 'Initials': 'R', 'LastName': 'Ducloux', 'Affiliation': 'APHP, Hôpital Corentin-Celton, Centre de Cicatrisation du Pied du Diabétique, Issy les Moulineaux, France.'}, {'ForeName': 'Abdelkader', 'Initials': 'A', 'LastName': 'Chibani', 'Affiliation': 'Department of Diabetology, Endocrinology and Nutrition, Centre Hospitalier Gonesse, Gonesse, France.'}, {'ForeName': 'Dominique-François', 'Initials': 'DF', 'LastName': 'Eveno', 'Affiliation': 'Department of Functional Rehabilitation, Centre Hospitalier La Tourmaline, La Tourmaline, France.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Crea Avila', 'Affiliation': 'Department of Diabetology, Endocrinology and Nutrition, Centre Hospitalier Régional de Metz-Thionville, Thionville, France.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Sultan', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, CHRU Montpellier, Montpellier, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Baillet-Blanco', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, CHU Bordeaux, Haut Lévèque Hospital, Pessac, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Rigalleau', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, CHU Bordeaux, Haut Lévèque Hospital, Pessac, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Gand', 'Affiliation': 'INSERM CIC 1402, University of Poitiers, CHU Poitiers, Poitiers, France.'}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Saulnier', 'Affiliation': 'INSERM CIC 1402, University of Poitiers, CHU Poitiers, Poitiers, France.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Velho', 'Affiliation': 'INSERM, UMR_S 1138, Centre de Recherche des Cordeliers, Paris, France.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'Roussel', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Pellenc', 'Affiliation': 'Vascular Surgery Department, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Dupré', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Malgrange', 'Affiliation': 'Endocrinology, Diabetology and Nutrition, Centre Hospitalier Universitaire de Reims, Reims, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Marre', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Kamel', 'Initials': 'K', 'LastName': 'Mohammedi', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, CHU Bordeaux, Haut Lévèque Hospital, Pessac, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000954']
69,32395474,The effect of RAS blockers on the clinical characteristics of COVID-19 patients with hypertension.,"Background
Coronavirus disease 2019 (COVID-19), caused by a novel coronavirus (designated as SARS-CoV-2) has become a pandemic worldwide. Based on the current reports, hypertension may be associated with increased risk of sever condition in hospitalized COVID-19 patients. Angiotensin-converting enzyme 2 (ACE2) was recently identified to functional receptor of SARS-CoV-2. Previous experimental data revealed ACE2 level was increased following treatment with ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs). Currently doctors concern whether these commonly used renin-angiotensin system (RAS) blockers-ACEIs/ARBs may increase the severity of COVID-19.
Methods
We extracted data regarding 50 hospitalized hypertension patients with laboratory confirmed COVID-19 in the Renmin Hospital of Wuhan University from Feb 7 to Mar 03, 2020. These patients were grouped into RAS blockers group (Group A, n=20) and non-RAS blockers group (Group B, n=30) according to the basic blood pressure medications. All patients continued to use pre-admission antihypertensive drugs. Clinical severity (symptoms, laboratory and chest CT findings, etc.), clinical course, and short time outcome were analyzed after hospital admission.
Results
Ten (50%) and seventeen (56.7%) of the Group A and Group B participants were males (P=0.643), and the average age was 52.65±13.12 and 67.77±12.84 years (P=0.000), respectively. The blood pressure of both groups was under effective control. There was no significant difference in clinical severity, clinical course and in-hospital mortality between Group A and Group B. Serum cardiac troponin I (cTnI) (P=0.03), and N-terminal (NT)-pro hormone BNP (NT-proBNP) (P=0.04) showed significant lower level in Group A than in Group B. But the patients with more than 0.04ng/mL or elevated NT-proBNP level had no statistical significance between the two groups. In patients over 65 years or under 65 years, cTnI or NT-proBNP level showed no difference between the two groups.
Conclusions
We observed there was no obvious difference in clinical characteristics between RAS blockers and non-RAS blockers groups. These data suggest ACEIs/ARBs may have few effects on increasing the clinical severe conditions of COVID-19.",2020,"In patients over 65 years or under 65 years, cTnI or NT-proBNP level showed no difference between the two groups.
","['COVID-19 patients with hypertension', '50 hospitalized hypertension patients with laboratory confirmed COVID-19 in the Renmin Hospital of Wuhan University from Feb 7 to Mar 03, 2020', 'hospitalized COVID-19 patients']","['non-RAS blockers', 'RAS blockers', 'Angiotensin-converting enzyme 2 (ACE2']","['Clinical severity (symptoms, laboratory and chest CT findings, etc.), clinical course, and short time outcome', 'blood pressure', 'elevated NT-proBNP level', 'cTnI or NT-proBNP level', 'clinical severity, clinical course and in-hospital mortality', 'ACE2 level', 'Serum cardiac troponin I (cTnI) (P=0.03), and N-terminal (NT)-pro hormone BNP (NT-proBNP']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0449259', 'cui_str': 'Clinical course'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}]",,0.0317682,"In patients over 65 years or under 65 years, cTnI or NT-proBNP level showed no difference between the two groups.
","[{'ForeName': 'Zheyong', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Jiatian', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yumeng', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Infection Disease, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Xuejuan', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'Department of Critical Medicine, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Critical Medicine, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Chouwen', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yunzeng', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Juying', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Kaihuan', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': 'Department of Hepatobiliary Surgery, Renmin Hospital of Wuhan University, Wuhan 430200, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}]",Annals of translational medicine,['10.21037/atm.2020.03.229']
70,32179237,Side effects of induced lateral eye movements during aversive ideation.,"BACKGROUND AND OBJECTIVES
Eye Movement Desensitization and Reprocessing (EMDR) is a treatment for posttraumatic stress disorder. It uses a dual-task approach, in which patients recall an aversive memory while making lateral eye movements. Research has shown that this 'eye movements' intervention reduces subjective memory vividness and emotionality. This study examined whether it also reduces memory accuracy on a visual discrimination task.
METHODS
Participants (68 undergraduates) underwent an aversive conditioning phase, in which two pictures of male faces were followed by shock. Then they recalled one face with (experimental condition) and one without (control condition) making lateral eye movements. Finally, they completed a stimulus discrimination test with slightly different faces shortly after the intervention and one day later.
RESULTS
Results showed that the eye movements intervention led to increased false-positive rates one day later.
LIMITATIONS
Our intervention targeted newly formed memory rather than consolidated memory.
CONCLUSIONS
The results inform theory about EMDR's mechanisms of change and suggest that the treatment may have side effects regarding memory accuracy.",2020,"BACKGROUND AND OBJECTIVES
Eye Movement Desensitization and Reprocessing (EMDR) is a treatment for posttraumatic stress disorder.","['Participants (68 undergraduates) underwent an', 'posttraumatic stress disorder']","['Reprocessing (EMDR', 'aversive conditioning phase']","['false-positive rates', 'memory accuracy']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0205557', 'cui_str': 'False positive (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0419655,"BACKGROUND AND OBJECTIVES
Eye Movement Desensitization and Reprocessing (EMDR) is a treatment for posttraumatic stress disorder.","[{'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Leer', 'Affiliation': 'Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'Engelhard', 'Affiliation': 'Utrecht University, Utrecht, the Netherlands. Electronic address: I.M.Engelhard@uu.nl.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101566']
71,32361696,"Evaluation of Curcumin (Turmeric Extract) Effect on Prevention of CIN in Patient Under Elective Coronary Angiography, a Randomized Double Blind Placebocontrolled Clinical Trial.","INTRODUCTION
Curcumin is turmeric extract that have antiproliferative, anti-cancer, and anti-oxidant effects and has been shown that it may have reno-protective properties. This study conducted to evaluate the efficacy of curcumin in the prevention of CIN.
METHODS
This randomized placebo-controlled clinical trial was carried out on 138 patients with chronic stable angina scheduled for elective coronary angiography that had renal insufficiency. Patients were randomized to receive curcumin or placebo in addition to standard hydration with saline 0.9% before nonionic iso-osmolar contrast agent administration for angiography. Serum creatinine was measured 12h before, 24h and 48h after contrast injection. CIN, mainly, defined as increase in creatinine of ≥ 0.5 mg/dL or ≥ 25% from the baseline.
RESULTS
Serum creatinine change was 0.19 ± 0.31 mg/dL which was 0.22 ± 0.33 and 0.16 ± 0.29 in placebo and curcumin group, respectively. In 'repeated measure analysis' no statistically difference was found in serum creatinine level between pre-intervention, and 24 hours and 48 hours after intervention. CIN was occurred less frequently, though statistically insignificant, in curcumin group (22.7%) compared with placebo group (32.3%).
CONCLUSION
It was found that although curcumin reduced the incidence of CIN, this difference was not statistically significant. It seems that, like other antioxidant substances studied in previous studies, although curcumin can reduce apoptosis and oxidative stress at cellular level, but in high risk patients for CIN, such as patients with renal insufficiency, it does not produce more protective effects than hydration with normal saline.",2020,"CIN was occurred less frequently, though statistically insignificant, in curcumin group (22.7%) compared with placebo group (32.3%).
","['138 patients with chronic stable angina scheduled for elective coronary angiography that had renal insufficiency', 'Patient Under Elective Coronary Angiography']","['curcumin', 'Curcumin (Turmeric Extract', 'curcumin or placebo', 'standard hydration with saline 0.9% before nonionic iso-osmolar contrast agent administration for angiography', 'placebo']","['Serum creatinine', 'serum creatinine level', 'CIN', 'Serum creatinine change', 'incidence of CIN']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0077524', 'cui_str': 'Turmeric extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0439351', 'cui_str': 'osmol/L'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0206708', 'cui_str': 'Cervical intraepithelial neoplasia'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",138.0,0.51775,"CIN was occurred less frequently, though statistically insignificant, in curcumin group (22.7%) compared with placebo group (32.3%).
","[{'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Sabaghian', 'Affiliation': 'Department of Nephrology, Shahid Beheshti University of Mediacal Science, Tehran, Iran; b Chronic Kidney Disease Research Center. ph.sabaghian@gmail.com.'}, {'ForeName': 'Mohammad Esmail', 'Initials': 'ME', 'LastName': 'Gheydari', 'Affiliation': ''}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Divani', 'Affiliation': ''}]",Iranian journal of kidney diseases,[]
72,32361698,"Effect of Sixteen Weeks Combined Training on FGF-23, Klotho, and Fetuin-A Levels in Patients on Maintenance Hemodialysis.","INTRODUCTION
Fibroblast growth factor 23 (FGF-23) and its cofactor alfa klotho, are one of the most important factors, directly and indirectly, involved in the process of calcification and atherosclerosis. This study aimed to evaluate the efficacy of a combination of regular exercise during dialysis on quality of life and markers including FGF-23, alfa klotho, and fetuin-A levels.
METHODS
Forty-five hemodialysis patients aged 61 ± 9.02 years and weight 69 ± 11.25 kg were randomly divided into two training, EX (n = 24) and control groups, CON (n = 21). The EX group patients participated in a 16-week combined aerobic and resistance exercise program during dialysis. Bone markers including, FGF-23, klotho, fetuin-A, were measured before and at the end of the study in both groups. Statistical analysis for comparing data change during study by SPSS software and the P value was set at .05.
RESULTS
In the control group in the secondary assessment, reduction in quality of life was observed (P < .05). Significant change in growth factor 23, CRP, and fetuin-A was not observed in exercise and control groups (P > .05), however significant rising of klotho was observed in treated patients (P < .05). Also, combined training reduced the amount of phosphorus, parathyroid hormone; significantly (P < .05).
CONCLUSION
This study showed that regular exercise during dialysis improves quality of life and physical functions. No significant change in FGF-23 and CRP were observed during the study. However significant rising of klotho and reduction of iPTH and phosphorous levels were observed in treated patients.",2020,"Also, combined training reduced the amount of phosphorus, parathyroid hormone; significantly (P < .05).
","['Forty-five hemodialysis patients aged 61 ± 9.02 years and weight 69 ± 11.25 kg', 'Patients on Maintenance Hemodialysis']","['regular exercise', 'combined aerobic and resistance exercise program during dialysis', 'regular exercise during dialysis', 'EX']","['quality of life', 'FGF-23, Klotho, and Fetuin-A Levels', 'amount of phosphorus, parathyroid hormone', 'FGF-23 and CRP', 'rising of klotho', 'iPTH and phosphorous levels', 'quality of life and markers including FGF-23, alfa klotho, and fetuin-A levels', 'quality of life and physical functions', 'growth factor 23, CRP, and fetuin-A']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517532', 'cui_str': '11.25'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C1144173', 'cui_str': 'KL protein, human'}, {'cui': 'C0051477', 'cui_str': 'Alpha>2< hS glycoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0047008', 'cui_str': ""3,4-O-isopropylidene-3,3',4,5'-tetrahydroxystilbene""}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}]",45.0,0.013129,"Also, combined training reduced the amount of phosphorus, parathyroid hormone; significantly (P < .05).
","[{'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Fakhrpour', 'Affiliation': ''}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Hamid Tayebi Khosroshahi', 'Affiliation': 'Kidney Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. drtayebikh@yahoo.com.'}, {'ForeName': 'Khosro', 'Initials': 'K', 'LastName': 'Ebrahim', 'Affiliation': ''}, {'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Ahmadizad', 'Affiliation': ''}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Abbasnejad', 'Affiliation': ''}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Mesgari Abbasi', 'Affiliation': ''}, {'ForeName': 'Allahverdi', 'Initials': 'A', 'LastName': 'Ghanbari', 'Affiliation': ''}, {'ForeName': 'Seyyed Fatemeh', 'Initials': 'SF', 'LastName': 'Yaghoobi', 'Affiliation': ''}]",Iranian journal of kidney diseases,[]
73,32370778,"Switching to Lurasidone following 12 months of treatment with Risperidone: results of a 6-month, open-label study.","BACKGROUND
Patients with a diagnosis of schizophrenia are at an increased risk for developing metabolic syndrome, which is associated with greater cardiovascular morbidity and mortality. Treatment with some commonly used antipsychotic medications may increase the risk of developing metabolic syndrome. The aim of the study was to evaluate the safety of lurasidone in patients who continued lurasidone or switched from risperidone to lurasidone. A secondary aim was assessment of the effect of long-term lurasidone on the Positive and Negative Syndrome Scale (PANSS).
METHODS
The treatment sample in the current study consisted of clinically stable patients with schizophrenia (N = 223) who had completed a 12-month, double-blind study of lurasidone vs. risperidone. In the current extension study, all patients received 6 months of open-label treatment with lurasidone, either continuing lurasidone assigned during the preceding double-blind trial, or switching from double-blind risperidone to lurasidone. Safety and tolerability parameters included body weight, prolactin, and metabolic laboratory tests.
RESULTS
Six months of OL treatment with lurasidone was generally well-tolerated, with a low incidence of parkinsonism (4.5%) and akathisia (3.1%). Overall, few adverse events were rated as severe (4.9%), and discontinuation due to an adverse event was low in the lurasidone continuation vs. risperidone switch groups (3.7% vs. 6.9%). In the lurasidone continuation versus risperidone switch groups, change from OL baseline to 6-month endpoint (observed case) was observed in mean body weight (- 0.6 vs. -2.6 kg), median total cholesterol (- 4.0 vs. + 4.5 mg/dL), triglycerides (- 4.5 vs. -5.5 mg/dL), glucose (0.0 vs. -3.0 mg/dL) and prolactin (males, + 0.15 vs. -11.2 ng/mL; females, + 1.3 vs. -30.8 ng/mL). Improvement in PANSS total score was maintained, from OL baseline to endpoint in the continuation vs. switch groups (+ 1.0 vs. -1.0; OC).
CONCLUSIONS
In this 6-month extension study, lurasidone treatment was generally well-tolerated and associated with minimal effects on weight, metabolic parameters, and prolactin levels. Patients who switched from risperidone to lurasidone experienced reductions in weight, metabolic parameters and prolactin levels commensurate with increases in these safety parameters experienced during the previous 12 months of treatment with risperidone.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00641745 (Date of Registration: March 24, 2008).",2020,"Patients who switched from risperidone to lurasidone experienced reductions in weight, metabolic parameters and prolactin levels commensurate with increases in these safety parameters experienced during the previous 12 months of treatment with risperidone.
","['patients who continued lurasidone or switched from risperidone to lurasidone', 'clinically stable patients with schizophrenia (N\u2009=\u2009223) who had completed a 12-month, double-blind study of', 'Patients with a diagnosis of schizophrenia']","['antipsychotic medications', 'risperidone to lurasidone', 'lurasidone', 'long-term lurasidone', 'lurasidone vs. risperidone', 'risperidone', 'Risperidone', 'open-label treatment with lurasidone, either continuing lurasidone']","['triglycerides', 'weight, metabolic parameters, and prolactin levels', 'Safety and tolerability parameters included body weight, prolactin, and metabolic laboratory tests', 'mean body weight', 'weight, metabolic parameters and prolactin levels', 'PANSS total score', 'Positive and Negative Syndrome Scale (PANSS', 'akathisia', 'risk of developing metabolic syndrome', 'median total cholesterol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",,0.0642573,"Patients who switched from risperidone to lurasidone experienced reductions in weight, metabolic parameters and prolactin levels commensurate with increases in these safety parameters experienced during the previous 12 months of treatment with risperidone.
","[{'ForeName': 'Greg W', 'Initials': 'GW', 'LastName': 'Mattingly', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Haddad', 'Affiliation': 'Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tocco', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, 84 Waterford Dr, Marlborough, MA, 01752, USA. paladinmed@gmail.com.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, 84 Waterford Dr, Marlborough, MA, 01752, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Phillips', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, 84 Waterford Dr, Marlborough, MA, 01752, USA.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Pikalov', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, 84 Waterford Dr, Marlborough, MA, 01752, USA.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Loebel', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, 84 Waterford Dr, Marlborough, MA, 01752, USA.'}]",BMC psychiatry,['10.1186/s12888-020-02523-1']
74,32383352,Phase I Single-Blinded Randomized Controlled Trial Comparing Balance and Aerobic Training in Degenerative Cerebellar Disease.,"INTRODUCTION
Primary deficits in individuals with cerebellar degeneration include ataxia, unstable gait, and incoordination. Balance training is routinely recommended to improve function whereas little is known regarding aerobic training.
OBJECTIVE
To determine the feasibility of conducting a randomized trial comparing balance and aerobic training in individuals with cerebellar degeneration.
DESIGN
Assessor blinded randomized control phase I trial.
SETTING
Assessments in medical center, home training.
PARTICIPANTS
Twenty participants with cerebellar degeneration were randomized to home balance or aerobic training.
INTERVENTION
Aerobic training consisted of 4 weeks of stationary bicycle training, five times per week for 30-minute sessions. Home balance training consisted of performing the same duration of easy, moderate, and/or hard exercises.
OUTCOME MEASURES
Scale for the Assessment and Rating of Ataxia (SARA), maximal oxygen consumption (VO 2 max), Dynamic Gait Index, Timed Up and Go, gait speed.
RESULTS
All 20 participants completed assigned training with no major adverse events. Seven of each group attained target training duration, frequency, and intensity. Although both groups had significant improvements in ataxia severity, balance, and gait measures, there were greater improvements in individuals who performed aerobic training in ataxia severity and maximal oxygen consumption when compared to balance training. The effect size for these outcome measures was determined to be large, indicating a phase II trial comparing the benefits of aerobic and balance training was feasible and required 26 participants per group. Improvements in SARA score and VO 2 max remained in the aerobic training group at 3 months posttraining, but these improvements were trending back to baseline. In contrast, all balance group measures for pretraining and 3 months posttraining were statistically similar.
CONCLUSIONS
A phase II trial comparing balance and aerobic training in individuals with cerebellar degeneration is feasible. Benefits trended back toward baseline after training stopped, although benefits of longer duration exercise programs still need to be determined.",2020,"Improvements in SARA score and VO 2 max remained in the aerobic training group at 3 mo post-training, but these improvements were trending back to baseline.","['Assessments in medical center, home-training', 'individuals with cerebellar degeneration', 'individuals with cerebellar degeneration is feasible', 'individuals with cerebellar degeneration include ataxia, unstable gait, and incoordination', '20 participants with cerebellar degeneration', 'Degenerative Cerebellar Disease']","['Aerobic training consisted of four-weeks of stationary bicycle training', 'aerobic and balance training', 'Balance training', 'aerobic training', 'home balance or aerobic training', 'Balance and Aerobic Training', 'balance and aerobic training']","['SARA score and VO 2 max', 'Scale for the Assessment and Rating of Ataxia (SARA), maximal oxygen consumption (VO2max), Dynamic Gait Index (DGI), Timed up and Go (TUG), gait speed', 'ataxia severity and maximal oxygen consumption', 'ataxia severity, balance, and gait measures']","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0262404', 'cui_str': 'Cerebellar degeneration'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0231686', 'cui_str': 'Unsteady gait'}, {'cui': 'C0520966', 'cui_str': 'Incoordination'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0007760', 'cui_str': 'Cerebellar disorder'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0392218', 'cui_str': 'Bicycle exerciser'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C4760258', 'cui_str': 'Ataxia assessment scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C2919794', 'cui_str': 'Dynamic gait index'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",20.0,0.0295574,"Improvements in SARA score and VO 2 max remained in the aerobic training group at 3 mo post-training, but these improvements were trending back to baseline.","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barbuto', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Martelli', 'Affiliation': 'Department of Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Omofuma', 'Initials': 'O', 'LastName': 'Isirame', 'Affiliation': 'Department of Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Bishop', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Sheng-Han', 'Initials': 'SH', 'LastName': 'Kuo', 'Affiliation': 'Department of Neurology, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Department of Engineering, Columbia University, New York, NY, USA.'}, {'ForeName': 'Seonjoo', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Dell"", 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Stein', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12401']
75,32380509,Role of feeding strategy bundle with acid-suppressive therapy in infants with esophageal acid reflux exposure: a randomized controlled trial.,"OBJECTIVE
To test the hypothesis that a feeding bundle concurrent with acid suppression is superior to acid suppression alone in improving gastroesophageal reflux disease (GERD) attributed-symptom scores and feeding outcomes in neonatal ICU infants.
METHODS
Infants (N = 76) between 34 and 60 weeks' postmenstrual age with acid reflux index > 3% were randomly allocated to study (acid-suppressive therapy + feeding bundle) or conventional (acid-suppressive therapy only) arms for 4 weeks. Feeding bundle included: total fluid volume < 140 mL/kg/day, fed over 30 min in right lateral position, and supine postprandial position. Primary outcome was independent oral feeding and/or ≥6-point decrease in symptom score (I-GERQ-R). Secondary outcomes included growth (weight, length, head circumference), length of hospital stay (LOHS, days), airway (oxygen at discharge), and developmental (Bayley scores) milestones.
RESULTS
Of 688 screened: 76 infants were randomized and used for the primary outcome as intent-to-treat, and secondary outcomes analyzed for 72 infants (N = 35 conventional, N = 37 study). For study vs. conventional groups, respectively: (a) 33% (95% CI, 19-49%) vs. 44% (95% CI, 28-62%), P = 0.28 achieved primary outcome success, and (b) secondary outcomes did not significantly differ (P > 0.05).
CONCLUSIONS
Feeding strategy modifications concurrent with acid suppression are not superior to PPI alone in improving GERD symptoms or discharge feeding, short-term and long-term outcomes.
IMPACT
Conservative feeding therapies are thought to modify GERD symptoms and its consequences. However, in this randomized controlled trial in convalescing neonatal ICU infants with GERD symptoms, when controlling for preterm or full-term birth and severity of esophageal acid reflux index, the effectiveness of acid suppression plus a feeding modification bundle (volume restriction, intra- and postprandial body positions, and prolonged feeding periods) vs. acid suppression alone, administered over a 4-week period was not superior in improving symptom scores or feeding outcomes.Restrictive feeding strategies are of no impact in modifying GERD symptoms or clinically meaningful outcomes. Further studies are needed to define true GERD and to identify effective therapies in modifying pathophysiology and outcomes.The improvement in symptoms and feeding outcomes over time irrespective of feeding modifications may suggest a maturational effect. This study justifies the use of placebo-controlled randomized clinical trial among NICU infants with objectively defined GERD.",2020,"CONCLUSIONS
Feeding strategy modifications concurrent with acid suppression are not superior to PPI alone in improving GERD symptoms or discharge feeding, short-term and long-term outcomes.
","['neonatal ICU infants', '72 infants (N\u2009=\u200935 conventional, N\u2009=\u200937 study', 'infants with esophageal acid reflux exposure', 'Of 688 screened: 76 infants', 'NICU infants with objectively defined GERD', ""Infants (N\u2009=\u200976) between 34 and 60 weeks' postmenstrual age with acid reflux index\u2009>\u20093"", 'convalescing neonatal ICU infants with GERD symptoms']","['study (acid-suppressive therapy\u2009+\u2009feeding bundle) or conventional (acid-suppressive therapy', 'Feeding bundle included: total fluid volume\u2009<\u2009140\u2009mL/kg/day, fed over 30\u2009min in right lateral position, and supine postprandial position', 'acid-suppressive therapy', 'placebo']","['oral feeding and/or ≥6-point decrease in symptom score (I-GERQ-R', 'growth (weight, length, head circumference), length of hospital stay (LOHS, days), airway (oxygen at discharge), and developmental (Bayley scores) milestones']","[{'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0856449', 'cui_str': 'Acid reflux (oesophageal)'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0205367', 'cui_str': 'Suppressive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1532579', 'cui_str': 'mL/kg/day'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0559228', 'cui_str': 'Right lateral decubitus position'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}]",76.0,0.114882,"CONCLUSIONS
Feeding strategy modifications concurrent with acid suppression are not superior to PPI alone in improving GERD symptoms or discharge feeding, short-term and long-term outcomes.
","[{'ForeName': 'Sudarshan R', 'Initials': 'SR', 'LastName': 'Jadcherla', 'Affiliation': ""Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, OH, USA. Sudarshan.Jadcherla@nationwidechildrens.org.""}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Hasenstab', 'Affiliation': ""Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Erika K', 'Initials': 'EK', 'LastName': 'Osborn', 'Affiliation': ""Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Sreekanth', 'Initials': 'S', 'LastName': 'Viswanathan', 'Affiliation': ""Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Ish K', 'Initials': 'IK', 'LastName': 'Gulati', 'Affiliation': ""Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Slaughter', 'Affiliation': ""Center for Perinatal Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Lorenzo', 'Affiliation': 'Department of Pediatrics, College of Medicine, The Ohio State University College of Medicine, Columbus, OH, USA.'}]",Pediatric research,['10.1038/s41390-020-0932-4']
76,32386395,Δ 9 -Tetrahydrocannabinol (THC) impairs visual working memory performance: a randomized crossover trial.,"With the increasing prevalence of legal cannabis use and availability, there is an urgent need to identify cognitive impairments related to its use. It is widely believed that cannabis, or its main psychoactive component Δ 9 -tetrahydrocannabinol (THC), impairs working memory, i.e., the ability to temporarily hold information in mind. However, our review of the literature yielded surprisingly little empirical support for an effect of THC or cannabis on working memory. We thus conducted a study with three main goals: (1) quantify the effect of THC on visual working memory in a well-powered sample, (2) test the potential role of cognitive effects (mind wandering and metacognition) in disrupting working memory, and (3) demonstrate how insufficient sample size and task duration reduce the likelihood of detecting a drug effect. We conducted two double-blind, randomized crossover experiments in which healthy adults (N = 23, 23) performed a reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC (7.5 and/or 15 mg oral) or placebo. We also assessed self-reported ""mind wandering"" (Exp 1) and metacognitive accuracy about ongoing task performance (Exp 2). THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2). Thus, our findings indicate that THC does impair visual working memory, and that this impairment may be related to both increased mind wandering and decreased monitoring of task performance. Finally, we used a down-sampling procedure to illustrate the effects of task length and sample size on power to detect the acute effect of THC on working memory.",2020,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","['healthy adults (N\u2009=\u200923, 23) performed a']","['THC', 'reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC', 'placebo', 'Tetrahydrocannabinol (THC']","['metacognitive accuracy about task performance', 'THC impaired working memory performance', 'visual working memory', 'visual working memory performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.14689,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","[{'ForeName': 'Kirsten C S', 'Initials': 'KCS', 'LastName': 'Adam', 'Affiliation': 'Department of Psychology, University of California San Diego, San Diego, CA, USA. kadam@ucsd.edu.'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Doss', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pabon', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Vogel', 'Affiliation': 'Grossman Institute for Neuroscience, Quantitative Biology, and Human Behavior, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0690-3']
77,32398077,Effect of a postpartum family planning intervention on postpartum intrauterine device counseling and choice: evidence from a cluster-randomized trial in Tanzania.,"BACKGROUND
The World Health Organization recommends postpartum family planning (PPFP) for healthy birth spacing. This study is an evaluation of an intervention that sought to improve women's access to PPFP in Tanzania. The intervention included counseling on PPFP during antenatal and delivery care and introducing postpartum intrauterine device (PPIUD) insertion as an integrated part of delivery services for women electing PPIUD in the immediate postpartum period.
METHODS
This cluster-randomized controlled trial recruited 15,264 postpartum Tanzanian women aged 18 or older who delivered in one of five study hospitals between January and September 2016. We present the effectiveness of the intervention using a difference-in-differences approach to compare outcomes, receipt of PPIUD counseling and choice of PPIUD after delivery, between the pre- and post-intervention period in the treatment and control group. We also present an intervention adherence-adjusted analysis using an instrumental variables estimation.
RESULTS
We estimate linear probability models to obtain effect sizes in percentage points (pp). The intervention increased PPIUD counseling by 19.8 pp (95% CI: 9.1 - 22.6 pp) and choice of PPIUD by 6.3 pp (95% CI: 2.3 - 8.0 pp). The adherence-adjusted estimates demonstrate that if all women had been counseled, we would have observed a 31.6 pp increase in choice of PPIUD (95% CI: 24.3 - 35.8 pp). Among women counseled, determinants of choosing PPIUD included receiving an informational leaflet during counseling and being counseled after admission for delivery services.
CONCLUSIONS
The intervention modestly increased the rate of PPIUD counseling and choice of PPIUD, primarily due to low coverage of PPIUD counseling among women delivering in study facilities. With universal PPIUD counseling, large increases in choice of PPIUD would have been observed. Giving women informational materials on PPIUD and counseling after admission for delivery are likely to increase the proportion of women choosing PPIUD.
TRIAL REGISTRATION
Registered with clinicaltrials.gov (NCT02718222) on March 24, 2016, retrospectively registered.",2020,The intervention increased PPIUD counseling by 19.8 pp (95% CI: 9.1 - 22.6 pp) and choice of PPIUD by 6.3 pp (95% CI: 2.3 - 8.0 pp).,"['15,264 postpartum Tanzanian women aged 18 or older who delivered in one of five study hospitals between January and September 2016', 'healthy birth spacing', ""women's access to PPFP in Tanzania""]","['intervention included counseling on PPFP during antenatal and delivery care and introducing postpartum intrauterine device (PPIUD) insertion as an integrated part of delivery services', 'postpartum family planning intervention']","['rate of PPIUD counseling and choice of PPIUD, primarily due to low coverage of PPIUD counseling', 'PPIUD counseling']","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C1171257', 'cui_str': 'Delivery care'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",15264.0,0.213227,The intervention increased PPIUD counseling by 19.8 pp (95% CI: 9.1 - 22.6 pp) and choice of PPIUD by 6.3 pp (95% CI: 2.3 - 8.0 pp).,"[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Pearson', 'Affiliation': 'Ipas, Chapel Hill, NC, USA. pearsone@ipas.org.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Senderowicz', 'Affiliation': 'University of Wisconsin - Madison School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Pradhan', 'Affiliation': 'World Bank, Washington, DC, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Francis', 'Affiliation': 'Department of Family Medicine and Primary Care, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Projestine', 'Initials': 'P', 'LastName': 'Muganyizi', 'Affiliation': 'Association of Gynaecologists and Obstetricians of Tanzania (AGOTA), Dar es Salaam, Tanzania.'}, {'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Shah', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Canning', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Karra', 'Affiliation': 'Boston University, Boston, MA, USA.'}, {'ForeName': 'Nzovu', 'Initials': 'N', 'LastName': 'Ulenga', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",BMC women's health,['10.1186/s12905-020-00956-0']
78,32396409,"A Prospective Randomized Controlled Trial of Irrigation ""Bag Squeeze"" to Manage Pain for Patients Undergoing Flexible Cystoscopy.","PURPOSE
We determined if the ""bag squeeze"" technique decreases pain during flexible cystoscopy in men.
MATERIALS AND METHODS
This single center, prospective, double-blind, randomized controlled trial recruited 200 consenting participants who were ambulatory, outpatient males who had undergone prior cystoscopy and were not expected to require any secondary procedures. Men with prior urethral stricture or bladder neck contracture were excluded from study. Once eligibility was assessed and consent obtained, participants were randomized to undergo cystoscopy with the bag squeeze (group A) or the sham bag squeeze procedure (group B). Following cystoscopy, participants completed a pain questionnaire (visual analogue scale). Differences in mean pain score between groups were evaluated using Students' t-test with a 2-sided alpha of 0.05.
RESULTS
A total of 200 patients were randomized and underwent flexible cystoscopy. Ten participants were ineligible because they required secondary procedures. Among the 190 eligible patients 97 were randomized to bag squeeze (group A) and 93 to sham bag squeeze (group B) with mean pain scores of 1.91 and 3.39, respectively (p <0.005).
CONCLUSIONS
This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation bag squeeze technique was used vs placebo bag squeeze. Accordingly, this useful, simple and free method to improve patient comfort during flexible cystoscopy should be adopted by clinicians.",2020,"This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation ""bag-squeeze"" technique was employed versus placebo bag-squeeze.","['Ten participants were ineligible because they required secondary procedures', 'Two hundred patients', 'Patients Undergoing Flexible Cystoscopy', '200 consenting participants who were ambulatory, outpatient males who had undergone a prior cystoscopy and were not expected to require any secondary procedures', '190 eligible patients, 97 were randomized to', 'men', 'Men with prior urethral stricture or bladder neck contracture']","['bag-squeeze', 'flexible cystoscopy', 'Irrigation ""Bag Squeeze', 'bag-squeeze"" technique', 'cystoscopy with the ""bag-squeeze"" (group A) or the sham bag-squeeze procedure', 'irrigation bag during a flexible cystoscopy']","['mean pain score', 'pain questionnaire: visual analogue scale', 'pain perception', 'pain']","[{'cui': 'C0445275', 'cui_str': 'Secondary procedure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0577992', 'cui_str': 'Flexible cystoscopy'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0542404', 'cui_str': 'Stenosis of bladder neck'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0577992', 'cui_str': 'Flexible cystoscopy'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",200.0,0.261447,"This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation ""bag-squeeze"" technique was employed versus placebo bag-squeeze.","[{'ForeName': 'Mohamad Baker', 'Initials': 'MB', 'LastName': 'Berajoui', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ishan', 'Initials': 'I', 'LastName': 'Aditya', 'Affiliation': 'University of Toronto, School of Medicine, Toronto, Ontario, Canada.'}, {'ForeName': 'JaimeOmar', 'Initials': 'J', 'LastName': 'Herrera-Caceres', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Yazan', 'Initials': 'Y', 'LastName': 'Qaoud', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Lajkosz', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Ajib', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Glase', 'Affiliation': 'Department of Neurosciences, Carleton University, Ottawa, Ontario, Canada.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hersey', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Miran', 'Initials': 'M', 'LastName': 'Kenk', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hamilton', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Girish S', 'Initials': 'GS', 'LastName': 'Kulkarni', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alexandre R', 'Initials': 'AR', 'LastName': 'Zlotta', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jason Y', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Perlis', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Finelli', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Neil E', 'Initials': 'NE', 'LastName': 'Fleshner', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}]",The Journal of urology,['10.1097/JU.0000000000001139']
79,32360596,What factors modify the effect of monthly bolus dose vitamin D supplementation on 25-hydroxyvitamin D concentrations?,"The increasing use of vitamin D supplements has stimulated interest in identifying factors that may modify the effect of supplementation on circulating 25-hydroxyvitamin D (25(OH)D) concentrations. Such information is of potential interest to researchers, clinicians and patients when deciding on bolus dose of vitamin D supplementation. We carried out a large randomized controlled trial of 5110 adults aged 50-84 years, of European/Other (84%), Polynesian (11%) and Asian (5%) ethnicity, to whom we gave a standard dose of vitamin D 3 supplements (200,000 IU initially, then 100,000 IU monthly) which was taken with high adherence. All participants provided a baseline blood sample, and follow-up blood samples were collected at 6 months and annually for 3 years in a random sample of 441 participants, and also at 2 years in 413 participants enrolled in a bone density sub-study. Serum 25(OH)D was measured by LC/MSMS. Mixed model analyses were carried out on all 854 participants providing follow-up blood samples in multivariable models that included age, sex, ethnicity, body mass index (kg/m 2 ), tobacco smoking, alcohol intake, physical activity, sun exposure, season, medical prescription of high-dose vitamin D 3 (Cal.D.Forte tablets), asthma/COPD and the study treatment (vitamin D or placebo). The adjusted mean difference in 25(OH)D in the follow-up points between vitamin D supplementation and placebo groups was inversely related (all p for interaction <0.05) to baseline 25(OH)D, BMI, and hours of sun exposure, and higher in females, elders, and those with high frequency of alcohol, medical prescription of vitamin D, and asthma/COPD. The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33). In summary, these data show that vitamin D status, BMI, sun exposure hours, sex and asthma/COPD modify the 25(OH)D response to vitamin D supplementation. By contrast, ethnicity, tobacco smoking, and vigorous activity do not.",2020,"The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33).","['5,110 adults aged 50-84 years, of European/Other (84%), Polynesian (11%) and Asian (5%) ethnicity', 'All participants provided a baseline blood sample, and follow-up blood samples were collected at 6 months and annually for 3 years in a random sample of 441 participants, and also at 2 years in 413 participants enrolled in a bone density sub-study', '854 participants providing follow-up blood samples in multivariable models that included age, sex, ethnicity, body mass index (kg/m 2 ), tobacco smoking, alcohol intake, physical activity, sun exposure, season, medical prescription of high-dose vitamin D 3 (Cal']","['vitamin D supplements', 'vitamin D 3 supplements', 'vitamin D or placebo', 'vitamin D supplementation', 'placebo']","['vigorous activity', 'circulating 25-hydroxyvitamin D (25(OH)D) concentrations', 'baseline 25(OH)D, BMI, and hours of sun exposure', 'Serum 25(OH)D', '25-hydroxyvitamin D concentrations', 'vitamin D status, BMI, sun exposure hours, sex and asthma/COPD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0240790', 'cui_str': 'Polynesians'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]","[{'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",5110.0,0.281124,"The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33).","[{'ForeName': 'Zhenqiang', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Beros', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Sluyter', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Waayer', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Carlene M M', 'Initials': 'CMM', 'LastName': 'Lawes', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Les', 'Initials': 'L', 'LastName': 'Toop', 'Affiliation': 'Department of Public Health & General Practice, The University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Kay-Tee', 'Initials': 'KT', 'LastName': 'Khaw', 'Affiliation': 'Department of Public Health, University of Cambridge, Cambridge, England, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand. Electronic address: r.scragg@auckland.ac.nz.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105687']
80,32370804,The effect of prenatal counseling on breastfeeding self-efficacy and frequency of breastfeeding problems in mothers with previous unsuccessful breastfeeding: a randomized controlled clinical trial.,"BACKGROUND
Breastfeeding is one of the most important interfering factors in infants' health. Monitoring mothers' performance and providing them with the feedback helps to increase their self-efficacy, interest in learning, and level of performance. The present research evaluates the effect of prenatal counseling on the breastfeeding self-efficacy and frequency of breastfeeding problems in mothers with previous unsuccessful breastfeeding.
METHODS
This randomized controlled clinical trial was conducted on 108 pregnant women with unsuccessful breastfeeding in Tabriz health centers during 2017-2018. The participants were randomly assigned to intervention and control groups. The intervention group had four prenatal counseling sessions and the controls only received routine care. Then, the mothers who gave birth to their children received a counseling session up to 4 months after the delivery. The Breastfeeding Self-Efficacy (BSES) questionnaire and the frequency of breast feeding problems checklist on the 15th day, and 2nd and 4th month were completed both by the intervention and control groups.
RESULTS
The mean (SD) of breastfeeding self-efficacy was 119.3 (10.5), 128.3 (8.3) and 133.8 (10.3) in the intervention group and 105.3 (16.1), 105.7 (19.7) and 109.4 (24.7) in the control group on the 15th day, 2nd and 4th month after the delivery, respectively. There was a significant difference in terms of breastfeeding self-efficacy between intervention and control group on the 15th day (p < 0.001), and 2nd (p < 0.001) and 4th (p < 0.001) month after the delivery. The frequency of breastfeeding problems on the 15th (p = 0.008), 2nd (p < 0.001) and 4th (p < 0.001) after the delivery was significantly different in most cases of the intervention group when compared to the controls.
CONCLUSION
The results indicated that prenatal counseling can increase mothers' breastfeeding self-efficacy and solves most breastfeeding problems during postpartum period.
TRIAL REGISTRATION
IRCT20100109003027N19.",2020,"The frequency of breastfeeding problems on the 15th (p = 0.008), 2nd (p < 0.001) and 4th (p < 0.001) after the delivery was significantly different in most cases of the intervention group when compared to the controls.
","['mothers with previous unsuccessful breastfeeding', '108 pregnant women with unsuccessful breastfeeding in Tabriz health centers during 2017-2018']","['prenatal counseling sessions and the controls only received routine care', 'prenatal counseling', 'counseling session']","['self-efficacy, interest in learning, and level of performance', 'frequency of breastfeeding problems', ""mothers' breastfeeding self-efficacy and solves most breastfeeding problems"", 'mean (SD) of breastfeeding self-efficacy', 'Breastfeeding Self-Efficacy (BSES) questionnaire and the frequency of breast feeding problems checklist', 'breastfeeding self-efficacy and frequency of breastfeeding problems', 'breastfeeding self-efficacy']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0856472', 'cui_str': 'Breast feeding problem (infant)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",108.0,0.0442206,"The frequency of breastfeeding problems on the 15th (p = 0.008), 2nd (p < 0.001) and 4th (p < 0.001) after the delivery was significantly different in most cases of the intervention group when compared to the controls.
","[{'ForeName': 'Fahimeh Sehhatie', 'Initials': 'FS', 'LastName': 'Shafaei', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Social Determinants of Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Havizari', 'Affiliation': 'Student Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. shiva.havizary@gmail.com.'}]",BMC women's health,['10.1186/s12905-020-00947-1']
81,32376034,The effect of function-focused care on long-term care workers in South Korea.,"The purpose of this study was to identify the effects of the Korean Function-Focused Care Program (K-FFCP) for residents of long-term care facilities (LTCRs) on long-term care workers' (LTCWs) knowledge, self-efficacy, and outcome expectations about function-focused care, as well as on their job satisfaction. The study adopted a quasi-experimental repeated-measures design. Participants included 50 LTCWs from two long-term care facilities (24 in the experimental group and 26 in the control group). Multivariate analysis of covariance showed that the effects of K-FFCP were significant on knowledge, efficacy, outcome expectation, and job satisfaction. Outcomes that could not be measured using scales were assessed through a focus group interview. The results suggest that LTCWs would benefit from a long-term educational program on function-focused care.",2020,"Multivariate analysis of covariance showed that the effects of K-FFCP were significant on knowledge, efficacy, outcome expectation, and job satisfaction.","['residents of long-term care facilities (LTCRs', 'Participants included 50 LTCWs from two long-term care facilities (24 in the experimental group and 26 in the control group', 'long-term care workers in South Korea']","['Korean Function-Focused Care Program (K-FFCP', 'LTCWs']","['knowledge, efficacy, outcome expectation, and job satisfaction']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}]",50.0,0.0158224,"Multivariate analysis of covariance showed that the effects of K-FFCP were significant on knowledge, efficacy, outcome expectation, and job satisfaction.","[{'ForeName': 'Dukyoo', 'Initials': 'D', 'LastName': 'Jung', 'Affiliation': 'College of Nursing, Ewha Womans University, 309 Hellen hall, 52, Ewhayeodae-gil, Seodaemun-gu, Seoul 120-750, Republic of Korea. Electronic address: dyjung@ewha.ac.kr.'}, {'ForeName': 'Jennie C', 'Initials': 'JC', 'LastName': 'De Gagne', 'Affiliation': 'Duke University School of Nursing, United States. Electronic address: jennie.degagne@duke.edu.'}, {'ForeName': 'Minkyung', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Hunter-Bellevue School of Nursing, Hunter College, CUNY, United States.'}, {'ForeName': 'Hyesoon', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Ewha Womans University, 309 Hellen hall, 52, Ewhayeodae-gil, Seodaemun-gu, Seoul 120-750, Republic of Korea. Electronic address: sunnysoonlee@nate.com.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.03.017']
82,32386077,The effect of tailored consumer medicine information on patients with type 2 diabetes mellitus: A randomised controlled interventional study.,"INTRODUCTION
In patients with diabetes, better health communication is associated with better health outcomes including medication adherence and glycaemic control. The conventional patient information leaflet does not consider the cultural and behavioral perspectives of diverse patient populations. Consumer medicine information (CMI) is a written information about the prescription drugs developed by organisations or individuals other than a drug manufacturer that is intended for distribution to consumers at the time of medication dispensing.
OBJECTIVE
This study aimed to evaluate the impact of CMI on medication adherence and glycaemic control among patients with type 2 diabetes in Qatar.
METHODS
We developed and customised CMI for all the anti-diabetic medications used in Qatar. A randomised controlled trial in which the intervention group patients (n = 66) received the customised CMI with usual care, while the control group patients (n = 74) received usual care only, was conducted. Self-reported medication adherence and haemoglobin A 1c (HbA 1c ) were the primary outcome measures. Glycaemic control and medication adherence parameters were measured at baseline, 3 months, and 6 months in both groups. Medication adherence was measured using the 8-item Morisky Medication Adherence Scale (MMAS-8).
RESULTS
Although the addition of CMI resulted in better glycaemic control, this did not reach statistical significance, possibly because of the short-term follow-up. The median MMAS-8 score improved from baseline (6.6 [IQR = 1.5]) to 6-month follow-up (7.0 [IQR = 1.00]) in the intervention group. In addition, there was a statistically significant difference between the intervention and the control groups in terms of MMAS-8 score at the third visit (7.0 [IQR = 1.0]) vs 6.5 (IQR = 1.25; P-value = .010).
CONCLUSION
CMI for anti-diabetic medications when added to usual care has the potential to improve medication adherence and glycaemic control among patients with type 2 diabetes. Therefore, providing better health communication and CMI to patients with diabetes is recommended.",2020,"In addition, there was a statistically significant difference between the intervention and control groups in terms of MMAS-8 score at the third visit [7.0 (IQR=1.0) vs. 6.5 (IQR=1.25; p-value= 0.010).
","['patients with T2DM', 'patients with diabetes in Qatar', 'Patients with Type 2 Diabetes Mellitus', 'group patients (n=66) received the']","['customized CMI with usual care, while the control group patients (n=74) received usual care', 'Consumer Medicine Information', 'CMI', 'intervention', 'Consumer medicine information (CMI']","['Medication adherence', '8-item Morisky Medication Adherence Scale (MMAS-8', 'medication adherence and glycemic control', 'Glycemic control and medication adherence parameters', 'median MMAS-8 score', 'Self-reported medication adherence and hemoglobin', 'MMAS-8 score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034366', 'cui_str': 'Qatar'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0511414,"In addition, there was a statistically significant difference between the intervention and control groups in terms of MMAS-8 score at the third visit [7.0 (IQR=1.0) vs. 6.5 (IQR=1.25; p-value= 0.010).
","[{'ForeName': 'Emad E', 'Initials': 'EE', 'LastName': 'Munsour', 'Affiliation': 'Pharmacy and Drug Control Department, Ministry of Public Health, Doha, Qatar.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Awaisu', 'Affiliation': 'Department of Clinical Pharmacy and Practice, College of Pharmacy, QU Health, Qatar University, Doha, Qatar.'}, {'ForeName': 'Mohamed Azmi A', 'Initials': 'MAA', 'LastName': 'Hassali', 'Affiliation': 'School of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden, Penang, Malaysia.'}, {'ForeName': 'Enas', 'Initials': 'E', 'LastName': 'Abdoun', 'Affiliation': 'Pharmacy Department, National Diabetes Center, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Dabbous', 'Affiliation': 'Diabetes/Endocrinology, National Diabetes Center, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Noran', 'Initials': 'N', 'LastName': 'Zahran', 'Affiliation': 'Department of Clinical Pharmacy and Practice, College of Pharmacy, QU Health, Qatar University, Doha, Qatar.'}, {'ForeName': 'Hamda', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'Diabetes/Endocrinology, National Diabetes Center, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar.'}]",International journal of clinical practice,['10.1111/ijcp.13527']
83,32393129,Copayment Reduction Voucher Utilization and Associations With Medication Persistence and Clinical Outcomes: Findings From the ARTEMIS Trial.,"BACKGROUND
Cost is frequently cited as a barrier to optimal medication use, but the extent to which copayment assistance interventions are used when available, and their impact on evidence-based medication persistence and major adverse cardiovascular events is unknown.
METHODS AND RESULTS
The ARTEMIS trial (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) randomized 301 hospitals to usual care versus the ability to provide patients with vouchers that offset copayment costs when filling P2Y 12 inhibitors in the 1 year post-myocardial infarction. In the intervention group, we used multivariable logistic regression to identify patient and medication cost characteristics associated with voucher use. We then used this model to stratify both intervention and usual care patients by likelihood of voucher use, and examined the impact of the voucher intervention on 1-year P2Y 12 inhibitor persistence (no gap in pharmacy supply >30 days) and major adverse cardiovascular events (all-cause death, myocardial infarction, or stroke). Among 10 102 enrolled patients, 6135 patients were treated at hospitals randomized to the copayment intervention. Of these, 1742 (28.4%) never used the voucher, although 1729 (99.2%) voucher never-users filled at least one P2Y 12 inhibitor prescription in the 1 year post-myocardial infarction. Characteristics most associated with voucher use included: discharge on ticagrelor, planned 1-year course of P2Y 12 inhibitor treatment, white race, commercial insurance, and higher out-of-pocket medication costs (c-statistic 0.74). Applying this propensity model to stratify all enrolled patients by likelihood of voucher use, the intervention improved medication persistence the most in patients with high likelihood of voucher use (adjusted interaction P =0.03, odds ratio, 1.86 [95% CI, 1.48-2.33]). The intervention did not significantly reduce major adverse cardiovascular events in any voucher use likelihood group, although the odds ratio was lowest (0.86 [95% CI, 0.56-1.16]) among patients with high likelihood of voucher use (adjusted interaction P =0.04).
CONCLUSIONS
Among patients discharged after myocardial infarction, those with higher copayments and greater out-of-pocket medication costs were more likely to use a copayment assistance voucher, but some classes of patients were less likely to use a copayment assistance voucher. Patients at low likelihood of voucher use benefitted least from copayment assistance, and other interventions may be needed to improve medication-taking behaviors and clinical outcomes in these patients. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02406677.",2020,"The intervention did not significantly reduce major adverse cardiovascular events in any voucher use likelihood group, although the odds ratio was lowest (0.86 [95% CI, 0.56-1.16]) among patients with high likelihood of voucher use (adjusted interaction P =0.04).
","['301 hospitals to usual care versus the ability to provide patients with vouchers that offset copayment costs when filling P2Y 12 inhibitors in the 1 year post-myocardial infarction', '10 102 enrolled patients, 6135 patients were treated at hospitals randomized to the copayment intervention']",[],"['major adverse cardiovascular events (all-cause death, myocardial infarction, or stroke', 'major adverse cardiovascular events']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",10102.0,0.0693459,"The intervention did not significantly reduce major adverse cardiovascular events in any voucher use likelihood group, although the odds ratio was lowest (0.86 [95% CI, 0.56-1.16]) among patients with high likelihood of voucher use (adjusted interaction P =0.04).
","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Fanaroff', 'Affiliation': 'Penn Cardiovascular Outcomes, Quality and Evaluative Research Center, Leonard Davis Institute of Health Economics, Cardiovascular Medicine Division, University of Pennsylvania, Philadelphia (A.C.F.).'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Division of Cardiology (E.D.P., T.Y.W.), Duke University, Durham, NC.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kaltenbach', 'Affiliation': 'the Duke Clinical Research Institute (E.D.P., L.A.K., K.J.A., T.Y.W.), Duke University, Durham, NC.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'the Duke Clinical Research Institute (E.D.P., L.A.K., K.J.A., T.Y.W.), Duke University, Durham, NC.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Division of Cardiology, Ronald Reagan UCLA Medical Center, Los Angeles, CA (G.C.F.).'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, OH (T.D.H.).'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Division of Cardiology (C.P.P.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Niteesh K', 'Initials': 'NK', 'LastName': 'Choudhry', 'Affiliation': ""Center for Healthcare Delivery Sciences, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine (N.K.C.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City School of Medicine, Kansas City, MO (D.J.C.).'}, {'ForeName': 'Nipun', 'Initials': 'N', 'LastName': 'Atreja', 'Affiliation': 'AstraZeneca, Wilmington, DE (N.A., N.B., J.M.E.).'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Bhalla', 'Affiliation': 'AstraZeneca, Wilmington, DE (N.A., N.B., J.M.E.).'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Eudicone', 'Affiliation': 'AstraZeneca, Wilmington, DE (N.A., N.B., J.M.E.).'}, {'ForeName': 'Tracy Y', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiology (E.D.P., T.Y.W.), Duke University, Durham, NC.'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006182']
84,32393169,Does the revised intubating laryngeal tube (ILTS-D2) perform better than the intubating laryngeal mask (Fastrach)? - a randomised simulation research study.,"BACKGROUND
The intubating laryngeal tube (ILTS-D™) and the intubating laryngeal mask (Fastrach™) are devices that facilitate both extraglottic application and blind tracheal intubation. A revised model of the iLTS-D (for scientific reasons called ILTS-D2) has been designed but not yet evaluated. Therefore, we compared the ILTS-D2 with the established Fastrach under controlled conditions in a prospective randomised controlled simulation research study.
METHODS
After ethical approval, we randomised 126 medical students into two groups. Each participant received either Fastrach or ILTS-D2 to perform five consecutive ventilation attempts in a manikin. The primary endpoint was the time to ventilation in the last attempt of using the devices as extraglottic devices. Secondary endpoints were the time to tracheal intubation and the success rates.
RESULTS
There was no relevant difference between the two devices in the time to ventilation in the last of five attempts (Fastrach: median 14 s [IQR: 12-15]; ILTS-D2: median 13 s [IQR: 12-15], p = 0.592). Secondary endpoints showed a 2 s faster blind tracheal intubation using the Fastrach than using the ILTS-D2 (Fastrach: median 14 s [IQR: 13-17]; ILTS-D2: median 16 s [IQR: 15-20] p < 0.001). For both devices, the success rates were 100% in the last attempt.
CONCLUSIONS
Concerning extraglottic airway management, we could not detect a relevant difference between the revised ILTS-D2 and the Fastrach under laboratory conditions. We advocate for an evaluation of the ILTS-D2 in randomised controlled clinical trials.
TRIAL REGISTRATION
Identifier at clinicaltrials.gov: NCT03542747. May 31, 2018.",2020,Secondary endpoints showed a 2 s faster blind tracheal intubation using the Fastrach than using the ILTS-D2 (Fastrach: median 14 s [IQR: 13-17]; ILTS-D2: median 16 s [IQR: 15-20] p < 0.001).,['126 medical students into two groups'],"['intubating laryngeal tube (ILTS-D™) and the intubating laryngeal mask (Fastrach™', 'Fastrach or ILTS-D2']","['2\u2009s faster blind tracheal intubation using the Fastrach', 'time to tracheal intubation and the success rates', 'time to ventilation', 'time to ventilation in the last attempt of using the devices as extraglottic devices', 'success rates']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}]","[{'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",,0.115281,Secondary endpoints showed a 2 s faster blind tracheal intubation using the Fastrach than using the ILTS-D2 (Fastrach: median 14 s [IQR: 13-17]; ILTS-D2: median 16 s [IQR: 15-20] p < 0.001).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ott', 'Affiliation': 'Department of Anaesthesiology, Medical Centre of the Johannes Gutenberg University, Langenbeckstr. 1, 55131, Mainz, Germany. ottth@uni-mainz.de.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Tschöpe', 'Affiliation': 'Department of Anaesthesiology, Medical Centre of the Johannes Gutenberg University, Langenbeckstr. 1, 55131, Mainz, Germany.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Toenges', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology, and Informatics, Medical Centre of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Buggenhagen', 'Affiliation': 'Rudolf-Frey Lernklinik Central Education Platform, Medical Centre of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Engelhard', 'Affiliation': 'Department of Anaesthesiology, Medical Centre of the Johannes Gutenberg University, Langenbeckstr. 1, 55131, Mainz, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kriege', 'Affiliation': 'Department of Anaesthesiology, Medical Centre of the Johannes Gutenberg University, Langenbeckstr. 1, 55131, Mainz, Germany.'}]",BMC anesthesiology,['10.1186/s12871-020-01029-3']
85,32396250,"Comparison of 40% trichloroacetic acid and cryotherapy for the treatment of plantar warts: A single-blind, randomized clinical trial.","Plantar warts can cause pain near the toes and the sole of the foot and may result in referral for treatment. This study was aimed at comparing 40% trichloroacetic acid (TCA) and cryotherapy (Cryo) for the treatment of plantar warts. This single-blind, randomized clinical trial was performed on 60 subjects presenting with plantar wart in Sabzevar, Iran in 2018. The first intervention group was treated with 40% TCA in four sessions within 4 weeks. The second intervention group was treated with Cryo using liquid nitrogen in four sessions within 8 weeks. The mean (SD) age of subjects was 20.16 ± 5.96 years and 68.33% (n = 41) were male. Although the resolution rate of warts in the TCA 40% group was greater than the Cryo group, there was no statistical association found between the two groups by adjusting age, sex, and basal time (P = .648). Findings suggest that although 40% TCA was almost as effective as Cryo in the treatment of plantar warts, considering the lower adverse effects of TCA 40% group as compared to the Cryo group, it could be a proper alternative.",2020,"Although the resolution rate of warts in the TCA 40% group was greater than the Cryo group, there was no statistical association found between the two groups by adjusting age, sex, and basal time (P = 0.648).
","['60 subjects presenting with plantar wart in Sabzevar, Iran in 2018', 'The mean (SD) age of subjects was 20.16 ±\u20095.96\u2009years and 68.33% (n=41) were male', 'plantar warts']","['Cryo using liquid nitrogen', 'TCA', 'trichloroacetic acid (TCA) and cryotherapy (Cryo', 'trichloroacetic acid and cryotherapy', '40% TCA']",['resolution rate of warts'],"[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042548', 'cui_str': 'Verruca plantaris'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0260055', 'cui_str': 'Liquid nitrogen'}, {'cui': 'C0040900', 'cui_str': 'Trichloroacetic acid'}]","[{'cui': 'C0043037', 'cui_str': 'Verruca'}]",60.0,0.041248,"Although the resolution rate of warts in the TCA 40% group was greater than the Cryo group, there was no statistical association found between the two groups by adjusting age, sex, and basal time (P = 0.648).
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karrabi', 'Affiliation': 'Department of Dermatology, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kheirkhah', 'Affiliation': 'Student Research Committee, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Shahrestanaki', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Smitha', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Clinical Research Pvt Ltd, Bangalore University, Bangalore, Karnataka, India.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebkar', 'Affiliation': 'Student Research Committee, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Dermatologic therapy,['10.1111/dth.13559']
86,30789780,Using a Psychopharmacogenetic Approach To Identify the Pathways Through Which-and the People for Whom-Testosterone Promotes Aggression.,"Little is known about the neurobiological pathways through which testosterone promotes aggression or about the people in whom this effect is observed. Using a psychopharmacogenetic approach, we found that testosterone increases aggression in men ( N = 308) with select personality profiles and that these effects are further enhanced among those with fewer cytosine-adenine-guanine (CAG) repeats in exon 1 of the androgen receptor (AR) gene, a polymorphism associated with increased AR efficiency. Testosterone's effects were rapid (~30 min after administration) and mediated, in part, by subjective reward associated with aggression. Testosterone thus appears to promote human aggression through an AR-related mechanism and to have stronger effects in men with the select personality profiles because it more strongly upregulates the subjective pleasure they derive from aggression. Given other evidence that testosterone regulates reward through dopaminergic pathways, and that the sensitivity of such pathways is enhanced among individuals with the personality profiles we identified, our findings may also implicate dopaminergic processes in testosterone's heterogeneous effects on aggression.",2019,"Testosterone's effects were rapid (~30 min after administration) and mediated, in part, by subjective reward associated with aggression.",['men ( N = 308) with select personality profiles'],"['testosterone', 'Testosterone']","['testosterone increases aggression', ""Testosterone's effects""]","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}]","[{'cui': 'C0241358', 'cui_str': 'Testosterone increased'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",308.0,0.0625313,"Testosterone's effects were rapid (~30 min after administration) and mediated, in part, by subjective reward associated with aggression.","[{'ForeName': 'Shawn N', 'Initials': 'SN', 'LastName': 'Geniole', 'Affiliation': '1 Department of Psychology, Nipissing University.'}, {'ForeName': 'Tanya L', 'Initials': 'TL', 'LastName': 'Procyshyn', 'Affiliation': '3 Department of Biological Sciences, Simon Fraser University.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marley', 'Affiliation': '1 Department of Psychology, Nipissing University.'}, {'ForeName': 'Triana L', 'Initials': 'TL', 'LastName': 'Ortiz', 'Affiliation': '1 Department of Psychology, Nipissing University.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Bird', 'Affiliation': '4 Department of Psychology, Simon Fraser University.'}, {'ForeName': 'Ashley L', 'Initials': 'AL', 'LastName': 'Marcellus', 'Affiliation': '1 Department of Psychology, Nipissing University.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Welker', 'Affiliation': '5 Department of Psychology, University of Massachusetts Boston.'}, {'ForeName': 'Pierre L', 'Initials': 'PL', 'LastName': 'Bonin', 'Affiliation': '6 Northern Ontario School of Medicine, Sudbury, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Goldfarb', 'Affiliation': '6 Northern Ontario School of Medicine, Sudbury, Canada.'}, {'ForeName': 'Neil V', 'Initials': 'NV', 'LastName': 'Watson', 'Affiliation': '4 Department of Psychology, Simon Fraser University.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Carré', 'Affiliation': '1 Department of Psychology, Nipissing University.'}]",Psychological science,['10.1177/0956797619826970']
87,32387531,The effect of presenting relative calorie information on calories ordered.,"In this research, we tested the effect of a novel method of presenting calorie information-highlighting relative differences in calories among ingredients. We conducted an online hypothetical food choice experiment where 633 participants selected the ingredients for a sandwich from five categories: meat/protein, cheese, spread/dressing, bread, and vegetables. Each participant was randomly assigned to one of four calorie information conditions: 1) a condition in which no information about calories was provided, 2) a condition in which calorie information was provided for each ingredient, 3) a condition in which calorie information was presented relative to the highest calorie item, and 4) a condition in which calorie information was presented relative to the lowest calorie item. Participants in the high- and low-calorie reference conditions ordered between 32 and 36 fewer calories per sandwich than participants in the no-calorie information control condition (p ≤ 0.04). Calories ordered by participants in the per-item calorie condition were not significantly different than the control. Presenting relative calorie or other nutritional information to make health-related trade-offs more salient may guide consumers to make healthier choices.",2020,Calories ordered by participants in the per-item calorie condition were not significantly different than the control.,"['633 participants selected the ingredients for a sandwich from five categories: meat/protein, cheese, spread/dressing, bread, and vegetables']","['condition in which no information about calories was provided, 2) a condition in which calorie information']",[],"[{'cui': 'C4543503', 'cui_str': 'Sandwich'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]",[],633.0,0.0417974,Calories ordered by participants in the per-item calorie condition were not significantly different than the control.,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Gustafson', 'Affiliation': 'Department of Agricultural Economics, University of Nebraska-Lincoln, 314A Filley Hall, Lincoln, NE, 68583, USA. Electronic address: cgustafson6@unl.edu.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Zeballos', 'Affiliation': 'USDA Economic Research Service, Food Economic Division, Washington, D.C, USA. Electronic address: eliana.zeballos@gmail.com.'}]",Appetite,['10.1016/j.appet.2020.104727']
88,32395379,Pro-inflammatory Cytokine Levels and Cancer-related Fatigue in Breast Cancer Survivors: Effects of an Exercise Adherence Program.,"Purpose
This study aimed to determine the effect of an exercise intervention on subjective cancer-related fatigue (CRF) and pro-inflammatory cytokine levels in breast cancer survivors (BCS).
Methods
BCS with greater than moderate CRF (≥ 4) were recruited and randomly assigned to experimental or control groups. The experimental group participated in a 12-week exercise adherence program (Better Life after Cancer - Energy, Strength, and Support; BLESS). Interleukin (IL)-6 and tumor necrosis factor-α (TNF-α) levels were determined at 3 time points (M1: baseline, M2: post-intervention, and M4: 6 months after intervention). Subjective fatigue was measured using the Korean version of the revised Piper Fatigue Scale.
Results
In this analysis of participants with physiological fatigue measures available (19 experimental, 21 control), there were no statistically significant differences in IL-6 (F = 1.157, p = 0.341), TNF-α levels (F = 0.878, p = 0.436), and level of fatigue (F = 2.067, p = 0.118) between the 2 groups at baseline. Fatigue in the experimental group showed statistically significant improvement compared to the control only at M2 ( p = 0.022). There was no significant relationship between subjective and physiological fatigue at the 3 measurement points.
Conclusion
The BLESS intervention improved CRF in BCS immediately at post-intervention, and this study presents clinical feasibility for the management of CRF in BCS in the early survivorship phase who are already experiencing fatigue.",2020,Fatigue in the experimental group showed statistically significant improvement compared to the control only at M2 ( p = 0.022).,"['Breast Cancer Survivors', 'breast cancer survivors (BCS']","['exercise intervention', 'Interleukin ', 'Exercise Adherence Program', 'exercise adherence program (Better Life after Cancer - Energy, Strength, and Support; BLESS']","['subjective cancer-related fatigue (CRF) and pro-inflammatory cytokine levels', 'TNF-α levels', 'IL)-6 and tumor necrosis factor-α (TNF-α) levels', 'Fatigue', 'IL-6', 'Subjective fatigue', 'level of fatigue', 'subjective and physiological fatigue']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",,0.0334036,Fatigue in the experimental group showed statistically significant improvement compared to the control only at M2 ( p = 0.022).,"[{'ForeName': 'Sung Hae', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, College of Health. Welfare and Education, Tongmyong University, Busan, Korea.'}, {'ForeName': 'Yoon Kyung', 'Initials': 'YK', 'LastName': 'Song', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Jeehee', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'College of Nursing, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Yun Hee', 'Initials': 'YH', 'LastName': 'Ko', 'Affiliation': 'College of Nursing, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Hyojin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Min Jae', 'Initials': 'MJ', 'LastName': 'Kang', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Hyunki', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Biobehavioral Center, Mo-Im Kim Nursing Research Institute, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Hyangkyu', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Mo-Im Kim Nursing Research Institute, College of Nursing, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Mo-Im Kim Nursing Research Institute, College of Nursing, Yonsei University, Seoul, Korea.'}]",Journal of breast cancer,['10.4048/jbc.2020.23.e22']
89,32397852,Topical Alpha-1 Adrenergic Receptor Agonist Applied to the Nipple/Areola Complex Improves Female Orgasmic Function.,"Background: The impact of nipple sensation and its relationship to sexual function have often been neglected in medical literature. However, several recent studies report the importance of the nipple/areola complex (NAC) in sexual arousal and overall function. The nipple is composed of smooth muscle that can be erected via adrenergic nerves. In two complementary studies, we demonstrate that stimulation of the alpha-1 adrenergic receptor in the NAC with topical adrenergic agents can initiate erection of the nipple, increase NAC sensitivity, and improve sexual function. Materials and Methods: Thirteen breast surgery patients with nipple sensitivity loss were recruited to an unblinded study of topical phenylephrine hydrochloride. Sensitivity to pressure was measured before and after the application of the intervention to the NAC. In a second pilot study, 35 women completed a double-blinded placebo-controlled trial of a novel formulation, RJ101, containing a norepinephrine releasing agent. The intervention or placebo was applied to the NAC 30 minutes before sexual activity over the 4-week trial period. The arousal, lubrication, and orgasm domains of the female sexual function index (FSFI) were used to measure sexual function. Results: The application of phenylephrine hydrochloride was shown to increase nipple sensitivity to pressure by an average of 20% in our cohort of 13 breast augmentation patients. In addition, it was shown that intermittent application of the alpha-1 agonist for 8 weeks increased basal NAC sensitivity. In the follow-up pilot study, we demonstrate that stimulation of the NAC with RJ101 produced statistically significant increases versus placebo in the lubrication and orgasm domains of the FSFI, p = 0.0226 and p = 0.0269, respectively. Conclusion: For the first time, we demonstrate that the application of a topical alpha-1 adrenergic receptor agonist or a norepinephrine-releasing agent increases the sensitivity of the NAC and subsequently significantly improves sexual function.",2020,The application of phenylephrine hydrochloride was shown to increase nipple sensitivity to pressure by an average of 20% in our cohort of 13 breast augmentation patients.,"['13 breast augmentation patients', 'Thirteen breast surgery patients with nipple sensitivity loss', '35 women completed a double-blinded']","['phenylephrine hydrochloride', 'topical phenylephrine hydrochloride', 'norepinephrine releasing agent', 'placebo']","['basal NAC sensitivity', 'sexual function', 'nipple sensitivity to pressure', 'Sensitivity to pressure', 'arousal, lubrication, and orgasm domains of the female sexual function index (FSFI']","[{'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0031470', 'cui_str': 'Phenylephrine hydrochloride'}, {'cui': 'C3212565', 'cui_str': 'Phenylephrine-containing product in cutaneous dose form'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",35.0,0.0262157,The application of phenylephrine hydrochloride was shown to increase nipple sensitivity to pressure by an average of 20% in our cohort of 13 breast augmentation patients.,"[{'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Goren', 'Affiliation': 'Applied Biology, Inc., Irvine, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McCoy', 'Affiliation': 'Applied Biology, Inc., Irvine, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Krychman', 'Affiliation': 'Southern California Center for Sexual Health and Survivorship Medicine, Newport Beach, California, USA.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Brandt', 'Affiliation': 'Applied Biology, Inc., Irvine, California, USA.'}, {'ForeName': 'Amadej', 'Initials': 'A', 'LastName': 'Lah', 'Affiliation': 'Estetika Fabjan D.O.O., Kranj, Slovenia.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Lonky', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Irvine, California, USA.'}]",Journal of women's health (2002),['10.1089/jwh.2019.8188']
90,32321450,Reno-protective effects of oral alkalizing agents in chronic kidney disease with aciduria: protocol for a randomized cohort study.,"BACKGROUND
Aciduria caused by urinary excretion of acidic metabolic wastes produced in daily life is known to be augmented in patients with chronic kidney disease (CKD). To evaluate the reno-protective effect of oral alkalizing agents for the improvement of metabolic acidosis and neutralization of intratubular pH in the patients with mild stages of CKD. Also, to identify reno-protective surrogate markers in the serum and urine that can closely associate the effect of urine alkalization.
METHODS
In this single-centered, open-labeled, randomized cohort study, patients with CKD stages G2, G3a and G3b, who visited and were treated at Tohoku University Hospital during the enrollment period were registered. We administered sodium bicarbonate or sodium-potassium citrate as the oral alkalinizing agents. A total of 150 patients with CKD will be randomly allocated into the following three groups: sodium bicarbonate, sodium-potassium citrate and standard therapy group without any alkalinizing agents. The data of performance status, venous blood test, spot urine test, venous blood-gas test, electrocardiogram, renal arterial ultrasonography and chest X-ray will be collected at 0, 6, 12 and 24 weeks (short-term study) from starting the interventions. These data will be also collected at 1 and 2 years (long-term study). The samples of plasma and serum and early-morning urine at every visit will be acquired for the analysis of renal function and surrogate uremic biomarkers. The recruitment for this cohort study terminated in March, 2018, and the follow-up period for all the enrolled subjects will be terminated in December, 2020. The primary endpoint will be the development of originally-defined significant renal dysfunction or the occurrence of any cerebrovascular disease in the short-term study. The secondary endpoint will be the same endpoints as in the long-term study, or the patients with significant changes in the suggested the surrogate biomarkers.
DISCUSSION
The findings of this study will address the importance of taking oral alkalizing agents in the patients with early stages of CKD, furthermore they could address any new surrogate biomarkers that can be useful from early stage CKD.
TRIAL REGISTRATION
Registered Report Identifier: UMIN000010059 and jRCT021180043. The trial registration number; 150. Date of registration; 2013/02/26.",2020,To evaluate the reno-protective effect of oral alkalizing agents for the improvement of metabolic acidosis and neutralization of intratubular pH in the patients with mild stages of CKD.,"['150 patients with CKD', 'patients with mild stages of CKD', 'patients with chronic kidney disease (CKD', 'chronic kidney disease with aciduria', 'patients with early stages of CKD', 'patients with CKD stages G2, G3a and G3b, who visited and were treated at Tohoku University Hospital during the enrollment period were registered']","['sodium bicarbonate, sodium-potassium citrate and standard therapy group without any alkalinizing agents', 'oral alkalizing agents', 'sodium bicarbonate or sodium-potassium citrate']","['metabolic acidosis and neutralization of intratubular pH', 'development of originally-defined significant renal dysfunction or the occurrence of any cerebrovascular disease', 'performance status, venous blood test, spot urine test, venous blood-gas test, electrocardiogram, renal arterial ultrasonography and chest X-ray']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0278026', 'cui_str': 'Aciduria'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0137996', 'cui_str': 'potassium citrate'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003138', 'cui_str': 'Antacid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0457208', 'cui_str': 'Spot urine sample'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}]",150.0,0.0349686,To evaluate the reno-protective effect of oral alkalizing agents for the improvement of metabolic acidosis and neutralization of intratubular pH in the patients with mild stages of CKD.,"[{'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Abe', 'Affiliation': 'Department of Education and Support for Regional Medicine, Tohoku University Hospital, Sendai, Miyagi, Japan. michiabe@med.tohoku.ac.jp.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Akaishi', 'Affiliation': 'Department of Education and Support for Regional Medicine, Tohoku University Hospital, Sendai, Miyagi, Japan.'}, {'ForeName': 'Mutsumi', 'Initials': 'M', 'LastName': 'Shoji', 'Affiliation': 'Department of Education and Support for Regional Medicine, Tohoku University Hospital, Sendai, Miyagi, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai, Miyagi, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Miki', 'Affiliation': 'Clinical Physiology Center, Tohoku University Hospital, Sendai, Miyagi, Japan.'}, {'ForeName': 'Fumitoshi', 'Initials': 'F', 'LastName': 'Satoh', 'Affiliation': 'Division of Nephrology, Endocrinology and Vascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Takayama', 'Affiliation': 'Department of Education and Support for Regional Medicine, Tohoku University Hospital, Sendai, Miyagi, Japan.'}, {'ForeName': 'Satomi', 'Initials': 'S', 'LastName': 'Yamasaki', 'Affiliation': 'Medical Affairs Department, Nippon Chemiphar Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Kawaguchi', 'Affiliation': 'Medical Affairs Department, Nippon Chemiphar Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'Division of Nephrology, Endocrinology and Vascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Ishii', 'Affiliation': 'Department of Education and Support for Regional Medicine, Tohoku University Hospital, Sendai, Miyagi, Japan.'}, {'ForeName': 'Sadayoshi', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Division of Nephrology, Endocrinology and Vascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC nephrology,['10.1186/s12882-020-01807-8']
91,31695136,"Maternal low molecular weight heparin versus sildenafil citrate for fetal growth restriction: a randomized, parallel groups, open-label clinical trial.","OBJECTIVES
To compare the effect of sildenafil citrate (SC) and low molecular weight heparin (LMWH) on neonatal birth weight (BW) and the fetoplacental blood flow in pregnancies with FGR.
STUDY DESIGN
A parallel groups, randomized clinical trial was conducted at a university hospital, between June 2017 and September 2018, involving 100 pregnant women with placental mediated FGR between 28 and 35 weeks of gestation who were randomly assigned to receive either SC or LMWH started at FGR diagnosis till delivery.
RESULTS
The neonatal BW in LMWH group was higher than SC group (p < 0.000) with a longer time from randomization till delivery, LMWH group had significant improvement in Ut A PI, UA PI, and MCA PI compared with SC treated group with p values 0.005, <0.000001, and 0.014, respectively.
CONCLUSION
The neonatal BW, time from randomization to delivery, and fetoplacental blood flow indices were significantly better with LMWH use compared with SC.",2020,"The neonatal BW in LMWH group was higher than SC group (p < 0.000) with a longer time from randomization till delivery, LMWH group had significant improvement in Ut A PI, UA PI, and MCA PI compared with SC treated group with p values 0.005, <0.000001, and 0.014, respectively.
","['fetal growth restriction', 'university hospital, between June 2017 and September 2018, involving 100 pregnant women with placental mediated FGR between 28 and 35 weeks of gestation', 'pregnancies with FGR']","['sildenafil citrate (SC) and low molecular weight heparin (LMWH', 'sildenafil citrate', 'SC or LMWH']","['neonatal BW', 'neonatal birth weight (BW', 'Ut A PI, UA PI, and MCA PI', 'neonatal BW, time from randomization to delivery, and fetoplacental blood flow indices']","[{'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]",100.0,0.0844184,"The neonatal BW in LMWH group was higher than SC group (p < 0.000) with a longer time from randomization till delivery, LMWH group had significant improvement in Ut A PI, UA PI, and MCA PI compared with SC treated group with p values 0.005, <0.000001, and 0.014, respectively.
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rasheedy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Cairo, Egypt. radwaebed@yahoo.com.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'El Bishry', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Tarek', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0544-1']
92,32112730,Prelabor screening at term using the cerebroplacental ratio and placental growth factor: a pragmatic randomized open-label phase 2 trial.,"BACKGROUND AND OBJECTIVE
In some women placental function may not be adequate to meet fetal growth requirements in late pregnancy or the additional demands during labor, thus predisposing these infants to intrapartum fetal compromise and subsequent serious morbidity and mortality. The objective of this study was to determine if the introduction of a prelabor screening test at term combining the cerebroplacental ratio and maternal placental growth factor level would result in a reduction in a composite of adverse outcomes.
STUDY DESIGN
Single-site, nonblinded, randomized controlled trial conducted at a tertiary hospital in Brisbane, Australia. Eligible women were randomized to either receive the screening test performed between 37-38 weeks or routine obstetric care. Screen-positive women were offered induction of labor. The primary outcome was a composite of emergency cesarean delivery for nonreassuring fetal status (fetal distress) or severe neonatal acidosis or low Apgar score or stillbirth or neonatal death.
RESULTS
Women were recruited and randomized (n = 501) between April 2017 and January 2019. Sixty-three of 249 subjects (25.3%) in the screened group compared to 56 of 252 (22.2%) in the control group experienced the primary outcome (relative risk = 1.14 [95% confidence interval, 0.83-1.56]; P = .418). Women who screened positive were more likely to require operative delivery for fetal distress, have meconium-stained liquor, have pathologic fetal heart rate abnormalities, and have infants with lower birthweight compared to women that screened negative.
CONCLUSION
The introduction of this test did not result in improvements in intrapartum intervention rates or neonatal outcomes. However, it did show discriminatory potential, and future research should focus on refining the thresholds used.",2020,The introduction of this test did not result in improvements in intrapartum intervention rates or neonatal outcomes.,"['Women were recruited and randomized (n=501) between April 2017 to January 2019', 'Eligible women', 'Single-site, non-blinded, randomized controlled trial conducted at a tertiary hospital in Brisbane, Australia']","['Pre-labor screening', 'screening test performed between 37-38 weeks or routine obstetric care']","['birth weight', 'composite of: emergency cesarean for non-reassuring fetal status (fetal distress) or severe neonatal acidosis or low Apgar score or stillbirth or neonatal death']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}]","[{'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0015930', 'cui_str': 'Nonreassuring Fetal Status'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4544436', 'cui_str': 'Neonatal acidosis'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0410916', 'cui_str': 'Neonatal Death'}]",,0.166963,The introduction of this test did not result in improvements in intrapartum intervention rates or neonatal outcomes.,"[{'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Sherrell', 'Affiliation': 'Mater Research Institute - University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Vicki L', 'Initials': 'VL', 'LastName': 'Clifton', 'Affiliation': 'Mater Research Institute - University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sailesh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Mater Research Institute - University of Queensland, Brisbane, Queensland, Australia; Mater Mothers' Hospital, Brisbane, Queensland, Australia; Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: sailesh.kumar@mater.uq.edu.au.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.02.034']
93,32143065,Remembering the past to live better in the future: A feasibility randomised controlled trial of memory specificity training for motivation in psychosis.,"BACKGROUND AND OBJECTIVES
People with a diagnosis of psychosis often experience low motivation and reduced activity levels. Autobiographical memory deficits have been identified in people with psychosis and this may limit the role of memory retrieval in supporting motivation. This pilot study adapted a recently developed protocol, Memflex, which aims to enhance autobiographical memory and has shown promise in depression. Our brief intervention targets experiential negative symptoms of psychosis using supported autobiographical memory retrieval.
METHOD
A sample of 31 participants with psychosis were recruited from inpatient and community settings and randomised in a 2:1 ratio to either a basic recall control or an enhanced recall intervention group. Participants were asked to generate positive autobiographical memories linked to activities they wish to repeat in the future. The enhanced recall condition received additional prompts from the Memflex protocol, and the basic recall condition received no additional support.
RESULTS
The intervention delivered was acceptable (rated >80%) and feasible (94% adherence) to those who took part. Participants were able to generate positive autobiographical memories linked to their goals and experienced appropriate emotions linked to these. The controlled preliminary effect sizes (0.2-0.34) showed encouraging signals for self-efficacy, motivation and a reduction in negative mood.
LIMITATIONS
As this was a pilot study with a small sample size between-group tests of statistical significance were not conducted, and therefore findings should be interpreted with caution.
CONCLUSIONS
These findings suggest that guided autobiographical memory retrieval may be an effective way tool for targeting motivation in people with psychosis.",2020,The intervention delivered was acceptable (rated >80%) and feasible (94% adherence) to those who took part.,"['31 participants with psychosis', 'people with psychosis', 'psychosis']","['basic recall control or an enhanced recall intervention group', 'memory specificity training']",['positive autobiographical memories'],"[{'cui': 'C0033975', 'cui_str': 'Psychoses'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}]",31.0,0.117268,The intervention delivered was acceptable (rated >80%) and feasible (94% adherence) to those who took part.,"[{'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Edwards', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK. Electronic address: clementine.edwards@kcl.ac.uk.""}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Garety', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hardy', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101564']
94,32171997,Context matters: The role of subjective arousal during Attentional Bias Modification targeting socially anxious students.,"BACKGROUND AND OBJECTIVES
Attentional Bias Modification (ABM) paradigms targeting anxiety aim to reduce attentional biases for threatening stimuli and thereby reduce anxiety. Based on cognitive theories of performance and learning, elevated levels of arousal during ABM might enhance its effectiveness by making training more engaging and activating fear schemas. This study investigated whether elevated levels of arousal during ABM would increase its effectiveness in reducing attentional bias, stress reactivity, and post-event processing.
METHOD
We randomly assigned 79 high socially anxious students to a session of ABM or control training preceded by either a social stress or control induction to manipulate arousal. Training outcomes were attentional bias, stress reactivity, and post-event processing. Subjective arousal was assessed before, during, and after training.
RESULTS
Results indicated that ABM was not successful in reducing attentional bias, stress reactivity or post-event processing, and that the effects of ABM were not moderated by subjective arousal. There was a trend towards ABM being more effective than control training in reducing attentional bias directly after training when participants were more aroused. However, this effect was not maintained one day after the training.
LIMITATIONS
The arousal manipulation did not result in significant between-group differences in subjective arousal.
CONCLUSIONS
This study did not provide support for the moderating role of arousal in ABM training effects. Replications with more effective mood induction procedures and more power are needed as a trend finding was observed suggesting that higher levels of arousal improved the direct ABM effects on attentional bias.",2020,There was a trend towards ABM being more effective than control training in reducing attentional bias directly after training when participants were more aroused.,"['79 high socially anxious students', 'socially anxious students']","['ABM', 'ABM or control training preceded by either a social stress or control induction to manipulate arousal', 'control training']","['attentional bias, stress reactivity or post-event processing', 'Subjective arousal', 'attentional bias, stress reactivity, and post-event processing', 'arousal manipulation', 'subjective arousal', 'attentional bias']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]",79.0,0.0681693,There was a trend towards ABM being more effective than control training in reducing attentional bias directly after training when participants were more aroused.,"[{'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Nuijs', 'Affiliation': 'Department of Developmental Psychology, Adapt Lab, Research Priority Area Yield, University of Amsterdam, Nieuwe Achtergracht 129-B, 1018 WS, Amsterdam, the Netherlands. Electronic address: M.D.Nuijs@uva.nl.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Larsen', 'Affiliation': 'Department of Developmental Psychology, Adapt Lab, Research Priority Area Yield, University of Amsterdam, Nieuwe Achtergracht 129-B, 1018 WS, Amsterdam, the Netherlands. Electronic address: H.Larsen@uva.nl.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Bögels', 'Affiliation': 'Department of Developmental Psychology, Adapt Lab, Research Priority Area Yield, University of Amsterdam, Nieuwe Achtergracht 129-B, 1018 WS, Amsterdam, the Netherlands. Electronic address: S.M.Bogels@uva.nl.'}, {'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Wiers', 'Affiliation': 'Department of Developmental Psychology, Adapt Lab, Research Priority Area Yield, University of Amsterdam, Nieuwe Achtergracht 129-B, 1018 WS, Amsterdam, the Netherlands. Electronic address: r.w.wiers@gmail.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Salemink', 'Affiliation': 'Department of Developmental Psychology, Adapt Lab, Research Priority Area Yield, University of Amsterdam, Nieuwe Achtergracht 129-B, 1018 WS, Amsterdam, the Netherlands; Clinical Psychology, Utrecht University, Heidelberglaan 1, 3584 CS, Utrecht, the Netherlands. Electronic address: E.Salemink@uu.nl.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101545']
95,32293314,The ResidentialCare Transition Module: a single-blinded randomized controlled evaluation of a telehealth support intervention for family caregivers of persons with dementia living in residential long-term care.,"BACKGROUND
Families do not fully disengage from care responsibilities following relatives' admissions to residential long-term (RLTC) care settings such as nursing homes. Caregiver stress, depression, or other key outcomes remain stable or sometimes increase following a relative's RLTC entry. Some interventions have attempted to increase family involvement after institutionalization, but few rigorous studies have demonstrated whether these interventions are effective in helping families navigate the potential emotional and psychological upheaval presented by relatives' transitions to RLTC environments. The Residential Care Transition Module (RCTM) provides six formal sessions of consultation (one-to-one and family sessions) over a 4-month period to family caregivers who have admitted a relative to a RLTC setting.
METHODS
In this embedded mixed methods randomized controlled evaluation, family members who have admitted a cognitively impaired relative to a RLTC setting are randomly assigned to the RCTM (n = 120) or a usual care control condition (n = 120). Primary outcomes include reductions in family members' primary subjective stress and negative mental health outcomes; secondary role strains; and residential care stress. The mixed methods design will allow for an analysis of intervention action mechanisms by ""embedding"" qualitative components (up to 30 semi-structured interviews) at the conclusion of the 12-month evaluation.
DISCUSSION
This evaluation will fill an important clinical and research gap by evaluating a psychosocial intervention designed for families following RLTC admission that determines whether and how the RCTM can help families better navigate the emotional and psychological challenges of residential care transitions.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT02915939, prospectively registered).",2020,Primary outcomes include reductions in family members' primary subjective stress and negative mental health outcomes; secondary role strains; and residential care stress.,"['family caregivers of persons with dementia living in residential long-term care', 'family members who have admitted a cognitively impaired relative to a RLTC setting', 'family caregivers who have admitted a relative to a RLTC setting']","['usual care control condition', 'Residential Care Transition Module (RCTM', 'telehealth support intervention', 'RCTM']","[""reductions in family members' primary subjective stress and negative mental health outcomes; secondary role strains; and residential care stress""]","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]",,0.118575,Primary outcomes include reductions in family members' primary subjective stress and negative mental health outcomes; secondary role strains; and residential care stress.,"[{'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Gaugler', 'Affiliation': 'Division of Health Policy and Management, School 8of Public Health, University of Minnesota, D351 Mayo (MMC 729), 420 Delaware Street S.E, Minneapolis, MN, 55455, USA. gaug0015@umn.edu.'}, {'ForeName': 'Tamara L', 'Initials': 'TL', 'LastName': 'Statz', 'Affiliation': 'Division of Health Policy and Management, School 8of Public Health, University of Minnesota, D351 Mayo (MMC 729), 420 Delaware Street S.E, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Robyn W', 'Initials': 'RW', 'LastName': 'Birkeland', 'Affiliation': 'Division of Health Policy and Management, School 8of Public Health, University of Minnesota, D351 Mayo (MMC 729), 420 Delaware Street S.E, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Katie W', 'Initials': 'KW', 'LastName': 'Louwagie', 'Affiliation': 'Division of Health Policy and Management, School 8of Public Health, University of Minnesota, D351 Mayo (MMC 729), 420 Delaware Street S.E, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Peterson', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Zmora', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Emery', 'Affiliation': 'Division of Health Policy and Management, School 8of Public Health, University of Minnesota, D351 Mayo (MMC 729), 420 Delaware Street S.E, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Hayley R', 'Initials': 'HR', 'LastName': 'McCarron', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Hepburn', 'Affiliation': ""Nell Hodgson Woodruff School of Nursing, Emory University Alzheimer's Disease Research Center, Emory University, Atlanta, GA, USA.""}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Whitlatch', 'Affiliation': 'Benjamin Rose Institute on Aging, Cleveland, OH, USA.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Mittelman', 'Affiliation': 'Department of Psychiatry, NYU School of Medicine, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Roth', 'Affiliation': 'Center on Aging and Health, Johns Hopkins University, Baltimore, MD, USA.'}]",BMC geriatrics,['10.1186/s12877-020-01542-7']
96,32394880,Immunogenicity and Safety of a Tetravalent Recombinant Subunit Dengue Vaccine in Adults Previously Vaccinated with a Live Attenuated Tetravalent Dengue Vaccine: Results of a Phase-I Randomized Clinical Trial.,"New dengue vaccines are needed to prevent this globally expanding vector-borne disease. The V180 vaccine candidate consists of four recombinant, soluble, dengue virus envelope glycoproteins and has been previously evaluated in two clinical trials for safety and immunogenicity in Flavivirus -naive participants (NCT01477580 and NCT0093642). Here, we report on a randomized, placebo-controlled, double-blind study of the safety and immunogenicity of the V180 vaccine in subjects who have previously received the live attenuated tetravalent vaccine (LATV) developed by the National Institute of Allergy and Infectious Diseases (protocol #V180-002 [CIR-301]). The study was designed to evaluate whether this recombinant subunit vaccine could boost the neutralizing antibody responses induced by dengue LATV. Twenty participants who had previously received one or two doses of dengue LATV were randomized and received a single dose of V180 nonadjuvanted ( N = 8), V180 adjuvanted with Alhydrogel™ (aluminum hydroxide gel, Brenntag Biosector, Frederikssund, Denmark) ( N = 8), or placebo ( N = 4). Immunogenicity was measured using a plaque reduction neutralization test at days 1, 15, 28, and 180 after vaccination. In addition, vaccine safety (solicited and unsolicited adverse events) was assessed using a vaccination report card for 28 days following vaccination, and serious adverse events were captured from the time of informed consent through the final study visit at 6 months after vaccination. The results of the study demonstrate that the V180 vaccine is generally well tolerated and immunogenic in these dengue-seropositive volunteers.",2020,The results of the study demonstrate that the V180 vaccine is generally well tolerated and immunogenic in these dengue-seropositive volunteers.,"['Adults', 'Twenty participants who had previously received one or two doses of dengue LATV', 'subjects who have previously received the live attenuated tetravalent vaccine (LATV) developed by the National Institute of Allergy and Infectious Diseases (protocol #V180-002 [CIR-301']","['V180 adjuvanted with Alhydrogel™ (aluminum hydroxide gel, Brenntag Biosector, Frederikssund, Denmark) ', 'placebo', 'Tetravalent Recombinant Subunit Dengue Vaccine', 'recombinant subunit vaccine', 'Live Attenuated Tetravalent Dengue Vaccine', 'V180 vaccine']","['vaccine safety (solicited and unsolicited adverse events', 'tolerated and immunogenic', 'neutralizing antibody responses', 'Immunogenicity and Safety', 'Immunogenicity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1513895', 'cui_str': 'National Institute of Allergy and Infectious Diseases'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0733770', 'cui_str': 'Alhydrogel'}, {'cui': 'C0002372', 'cui_str': 'algeldrate'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C0887892', 'cui_str': 'Vaccines, Subunit'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}]",20.0,0.508172,The results of the study demonstrate that the V180 vaccine is generally well tolerated and immunogenic in these dengue-seropositive volunteers.,"[{'ForeName': 'Anna P', 'Initials': 'AP', 'LastName': 'Durbin', 'Affiliation': 'Department of International Health, Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Pierce', 'Affiliation': 'Department of Microbiology and Molecular Genetics, Vaccine Testing Center, Larner College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Microbiology and Molecular Genetics, Vaccine Testing Center, Larner College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Palmtama', 'Initials': 'P', 'LastName': 'Grier', 'Affiliation': 'Department of International Health, Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Beulah P', 'Initials': 'BP', 'LastName': 'Sabundayo', 'Affiliation': 'Department of International Health, Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of International Health, Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Sausser', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Amy Falk', 'Initials': 'AF', 'LastName': 'Russell', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Hyatt', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Cook', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Sachs', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Andrew Wen-Tseng', 'Initials': 'AW', 'LastName': 'Lee', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Liman', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Beth-Ann', 'Initials': 'BA', 'LastName': 'Coller', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Whitehead', 'Affiliation': 'Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0042']
97,32396095,Home-Based Functional Electrical Stimulation-Assisted Hand Therapy Video Games for Children With Hemiplegia: Development and Proof-of-Concept.,"We describe the development and three case reports of a home-based intervention for children with hand hemiplegia that integrates custom video games with contralaterally controlled functional electrical stimulation (CCFES). With CCFES, stimulated opening of the more-affected hand is modulated by volitional opening of the less-affected hand. Video games that solicit goal-oriented, skill-requiring movement have shown promise for treating hemiplegia, but they have not previously been combined with electrical stimulation in children. Three children ages 8, 9, and 11 with moderate-to-severe hand hemiplegia were assigned six weeks of therapy in lab and at home. The goal was to determine if children could tolerate 9 lab treatment sessions and administer up to 7.5 hrs/wk of CCFES video game therapy at home. The feasibility of this intervention for home use was assessed by device logs, end-of-treatment interviews, and motor function/impairment assessments. With caregiver help, the children were all able to attend 9 lab sessions and built up to 7.5 hrs/wk of therapy by week 3. They averaged 5-7 hrs/wk of home intervention overall. Motor outcomes improved for all three participants at treatment end, but mostly regressed at 4-weeks follow-up. Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2. We found preliminary indications that CCFES-integrated video game therapy can provide a high dose of hand motor control therapy at home and in the lab. Improvements in motor outcomes were also observed, but more development and study is needed.",2020,"Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2.","['Children with Hemiplegia', 'Three children ages 8, 9, and 11 with moderate-to-severe hand hemiplegia', 'children with hand hemiplegia that integrates']","['custom video games with contralaterally controlled functional electrical stimulation (CCFES', 'CCFES-integrated video game therapy', 'home-based intervention', 'CCFES video game therapy', 'Home-Based Functional Electrical Stimulation-Assisted Hand Therapy Video Games']",['Motor outcomes'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0729315', 'cui_str': 'Hand therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}]",3.0,0.063265,"Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Curby', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Suder', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Katholi', 'Affiliation': ''}, {'ForeName': 'Jayme S', 'Initials': 'JS', 'LastName': 'Knutson', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2020.2992036']
98,32399799,Effect of FAmily CEntered (FACE®) Advance Care Planning on Longitudinal Congruence in End-of-Life Treatment Preferences: A Randomized Clinical Trial.,"Trial tested effect of advance care planning on family/surrogates' understanding of patients' end-of-life treatment preferences longitudinally. A multisite, assessor-blinded, intent-to-treat, parallel-group, randomized controlled clinical trial in five hospital-based HIV clinics enrolled 449 participants aged 22 to 77 years during October 2013-March 2017. Patients living with HIV/family dyads were randomized at 2:1 ratio to 2 weekly ~ 60-min sessions either ACP (n = 155 dyads)-(1) ACP facilitated conversation, (2) Advance directive completion; or Control (n = 68 dyads)-(1) Developmental/relationship history, (2) Nutrition/exercise tips. ACP families/surrogates were more likely to accurately report patients' treatment preferences at Time 1 (T 1 ) and 12 months post-intervention (T 2 ) compared to controls, experiencing high congruence longitudinally (high→high transition), [63·6% vs 37·7% (difference = 25·9%, 95% CI: 11·3%, 40·4%, χ 2 = 11·52, p = 0·01)], even as patients' preferences changed over time. ACP families/surrogates had eight times the odds of controls of having an excellent understanding of patients' treatment preferences (Adjusted Odds Ratio 7.91, 95%CI: 3.08, 20.3). Conversations matter.",2020,"ACP families/surrogates had eight times the odds of controls of having an excellent understanding of patients' treatment preferences (Adjusted Odds Ratio 7.91, 95%CI: 3.08, 20.3).","['five hospital-based HIV clinics enrolled 449 participants aged 22 to 77\xa0years during October 2013-March 2017', 'Patients living with HIV/family dyads', 'Longitudinal Congruence in End-of-Life Treatment Preferences']","['Control (n\u2009=\u200968 dyads)-(1', 'FAmily CEntered (FACE®', 'ACP (n\u2009=\u2009155 dyads)-(1', 'advance care planning', 'Advance Care Planning']",[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0001369', 'cui_str': 'Acyl Carrier Protein'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}]",[],449.0,0.0733186,"ACP families/surrogates had eight times the odds of controls of having an excellent understanding of patients' treatment preferences (Adjusted Odds Ratio 7.91, 95%CI: 3.08, 20.3).","[{'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Lyon', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Center for Translational Research/Children's Research Institute, Washington, DC, USA. mlyon@childrensnational.org.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Squires', 'Affiliation': 'Washington DC Veterans Affairs Medical Center, Washington, DC, USA.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Scott', 'Affiliation': 'MedStar: Health Research Institute and Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Benator', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Briggs', 'Affiliation': 'Respecting Choices, Coalition to Transform Advance Care Innovations, Washington, DC, USA.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Greenberg', 'Affiliation': ""Medical Education, Children's National, Washington, DC, USA.""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': ""D'Angelo"", 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Center for Translational Research/Children's Research Institute, Washington, DC, USA.""}, {'ForeName': 'Yao Iris', 'Initials': 'YI', 'LastName': 'Cheng', 'Affiliation': ""Division of Biostatistics & Study Methodology, Center for Translational Research/Children's Research Institute, Washington, DC, USA.""}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02909-y']
99,32334332,The effects of consecutive sessions of anodal transcranial direct current stimulation over the primary motor cortex on hand function in healthy older adults.,"BACKGROUND
With advancing age, changes in the central nervous system may lead to motor functional deficits. Non-invasive brain stimulation techniques are suggested to help modifying brain function.
OBJECTIVES
The aim of the current study was to investigate the effect of using multi session anodal transcranial Direct Current Stimulation (a-tDCS) over the primary motor cortex (M1) on the hand function in healthy older adults.
METHOD
In this randomized, double-blinded, sham-controlled study 32 participants received active or sham a-tDCS (1 mA, 20 min, for five consecutive days) and performed the Purdue Pegboard Test (PPT) on the first day before tDCS application, immediately (T1), 30 min (T2), and one week after the last session (5th day) (T3) of the stimulation.
RESULTS
There was a significant improvement for PPT (p < 0.05) in a-tDCS group at all post-test values except for PPT for left hand (PPTL) at T1. Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
CONCLUSION
The current findings suggest a-tDCS can be considered as a promising stand-alone technique in the intervention of the age-related decline of manual dexterity for improving hand function.",2020,"Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
","['32 participants received', 'healthy older adults']","['multi session anodal transcranial Direct Current Stimulation (a-tDCS', 'active or sham a-tDCS', 'anodal transcranial direct current stimulation']","['PPT', 'PPT subtests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0204462', 'cui_str': 'Purdue pegboard test'}]",32.0,0.0611213,"Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Rostami', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. Electronic address: zmosallanezhad@yahoo.com.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'Musculoskeletal Rehabilitation Research Center, Speech Therapy Department, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Dawson', 'Initials': 'D', 'LastName': 'Kidgell', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Tahere', 'Initials': 'T', 'LastName': 'Rezaeian', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Enayatollah', 'Initials': 'E', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Biostatistics, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghodrati', 'Affiliation': 'Health and Rehabilitation Sciences Program, University of Western Ontario, London, Canada.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104063']
100,32334940,Single-arm phase II trial to evaluate efficacy and tolerance of regorafenib monotherapy in patients over 70 with previously treated metastatic colorectal adenocarcinoma FFCD 1404 - REGOLD.,"BACKGROUND
Regorafenib significantly increases overall survival (OS) in patients with metastatic colorectal cancer previously treated but gives toxicities.
OBJECTIVES
to assess the efficacy and safety of regorafenib at it's approved dose in the older population.
PATIENTS AND METHODS
This multicenter single-arm phase II enrolled patients ≥70 years old after the failure of fluoropyrimidine-based chemotherapy, anti-VEGF, and anti-EGFR treatment. The primary endpoint was disease control rate (DCR) 2 months after initiation of regorafenib (160 mg/day, 3 weeks on/1 week off).
RESULTS
Forty-three patients were enrolled, with a median age of 77 years. The 2 months DCR was 31.4% in the 35 evaluable patients. For the 42 patients that received at least one dose of regorafenib, median progression-free survival and OS were 2.2 and 7.5 months. The median time to autonomy degradation and quality of life degradation was 3.1 and 3.2 months, respectively. A grade 3-4 treatment-related adverse events was observed in 35/42 patients, notably: fatigue (45.2%), hand-foot skin reaction (19.0%), hypertension (21.4%), and diarrhea (7.1%). There is a trend to achieve DCR in patients ≤80 years and a trend to discontinue the study due to toxicity in patients with ECOG ≥1, over 80 years and with impaired baseline autonomy.
CONCLUSION
Treatment with regorafenib in pretreated patients ≥70 years is feasible and demonstrate similar efficacy that was observed in previous studies in young patients. Fatigue is the most frequent severe adverse event. However, caution should be taken for older patients with ECOG ≥1, over 80 years, and with impaired baseline autonomy.",2020,"For the 42 patients that received at least one dose of regorafenib, median progression-free survival and OS were 2.2 and 7.5 months.","['enrolled patients ≥70\xa0years old after the failure of', 'older patients with ECOG ≥1, over 80\xa0years, and with impaired baseline autonomy', 'patients with metastatic colorectal cancer', 'Forty-three patients were enrolled, with a median age of 77\xa0years', 'young patients', 'patients over 70 with previously treated metastatic colorectal adenocarcinoma FFCD 1404 - REGOLD', 'older population', 'patients ≤80\xa0years']","['regorafenib monotherapy', 'fluoropyrimidine-based chemotherapy, anti-VEGF, and anti-EGFR treatment', 'regorafenib']","['disease control rate (DCR', 'diarrhea', 'overall survival (OS', 'median progression-free survival and OS', 'adverse events', 'efficacy and safety', 'hand-foot skin reaction', 'hypertension', 'median time to autonomy degradation and quality of life degradation', 'efficacy and tolerance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1319315', 'cui_str': 'Adenocarcinoma of large intestine'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",43.0,0.0405586,"For the 42 patients that received at least one dose of regorafenib, median progression-free survival and OS were 2.2 and 7.5 months.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Aparicio', 'Affiliation': 'Gastroenterology and Digestive Oncology Department, CHU Saint Louis, APHP, Université de Paris, Paris, France. Electronic address: thomas.aparicio@aphp.fr.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Darut-Jouve', 'Affiliation': 'Oncology Department, Institut de Cancerologie de Bourgogne, Dijon, France.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Khemissa Akouz', 'Affiliation': 'Hepatology-Gastroenterology Department, CH Perpignan, Hôpital Saint Jean, Perpignan, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Montérymard', 'Affiliation': 'Biostatistic Department, Fédération Francophone de Cancérologie Digestive, Dijon, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Artru', 'Affiliation': 'Oncology Department, Hôpital Jean Mermoz, Lyon, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Cany', 'Affiliation': 'Radiotherapy and Oncology Department, Polyclinique Francheville, Perigueux, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Romano', 'Affiliation': ""Oncology Départment, Institut de Cancérologie Lille Métropole, Villeneuve d'Ascq, France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Valenza', 'Affiliation': 'Oncology Department, CHI de Fréjus - Saint-Raphaël, Fréjus, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Le Foll', 'Affiliation': ""Oncology Department, Grand Hôpital de l'Est Francilien - site de Marne la Vallée, Jossigny, France.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Delbaldo', 'Affiliation': 'Oncology Department, Hôpital des Diaconesses - Croix Saint Simon, Paris, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Falandry', 'Affiliation': 'Oncology Department, CH Lyon Sud, Pierre Bénite, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Norguet Monnereau', 'Affiliation': 'Hepato-Gastroenterology and Medical Oncology Department, CHU La Timone, Marseille, France.'}, {'ForeName': 'Meher', 'Initials': 'M', 'LastName': 'Ben Abdelghani', 'Affiliation': 'Oncology Department, Centre Paul Strauss, Strasbourg, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Digestive Oncology Department, CHU of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rinaldi', 'Affiliation': 'Hepato-Gastroenterology Department, Hôpital Européen de Marseille, Marseille, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Père Verge', 'Affiliation': 'Hepato-Gastroenterology Department, Hôpital Saint Joseph - Saint Luc, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Baize', 'Affiliation': 'Oncology Department, Hôtel Dieu, CHU of Angers, Angers, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Maillard', 'Affiliation': 'Hepato-Gastroenterology Department, CH Annecy Genevois, Pringy, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Dohan', 'Affiliation': 'Radiology Department, CHU Cochin, APHP, Paris, France.'}, {'ForeName': 'Gaetan', 'Initials': 'G', 'LastName': 'Des Guetz', 'Affiliation': 'Oncology Department, CHU Dupuytren, Limoges, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Pamoukdjian', 'Affiliation': 'Geriatric Department, CHU Avicenne, APHP, Bobigny, France.'}, {'ForeName': 'Come', 'Initials': 'C', 'LastName': 'Lepage', 'Affiliation': 'Gastroenterology and Digestive Oncology Department, University Hospital Dijon, Dijon, France; EPICAD INSERM LNC-UMR 1231, Université de Bourgogne et Franche Comté, Dijon, France.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2020.04.001']
101,32315823,Coping with social wounds: How social pain and social anxiety influence access to social rewards.,"BACKGROUND AND OBJECTIVES
Prior studies have shown that people display signs of increased social approach motivation and affiliative behaviour in response to social exclusion. This response is considered an adaptive strategy that serves to repair damage to social networks and increase access to mood-enhancing social rewards. However, heightened trait social anxiety (SA) has been linked to decreased approach motivation and responsiveness to social rewards. In the current preliminary experimental study, we tested whether trait SA inhibits the expected increase in social approach following the pain of exclusion. We then tested whether diminished social approach is associated with reduced positive affect.
METHODS
Participants played a game of Cyberball and were randomly assigned to receive significantly fewer passes (exclusion condition) or an equal number of passes (control condition) as other players. Subsequently, participants were given the opportunity to engage in an online social interaction activity with avatars they believed were other participants.
RESULTS
Analyses revealed that the exclusion condition led to greater social pain than the control condition. Across conditions, greater social pain was associated with higher levels of approach motivation in anticipation of the social interaction activity, but only for individuals with lower levels of trait SA. Finally, when controlling for levels of trait SA, social pain was associated with positive affect following the social interaction activity, but only for individuals with higher levels of approach motivation.
LIMITATIONS
Participants consisted predominantly of female undergraduates, limiting generalizability of these data. As well, hypotheses were supported for the measure of approach motivation but not the measure of approach behaviour. Finally, this study was not powered to enable moderated mediation analyses, which would have provided the most direct test of the hypothesized model.
CONCLUSIONS
Heightened approach motivation in the face of social pain may facilitate increased positive affect. However, higher levels of trait SA dampen approach motivation. Future well-powered studies should use moderated mediation analyses to test the hypothesized model more parsimoniously.",2020,"RESULTS
Analyses revealed that the exclusion condition led to greater social pain than the control condition.","['Participants played a game of Cyberball and were randomly assigned to', 'Participants consisted predominantly of female undergraduates']",['receive significantly fewer passes (exclusion condition) or an equal number of passes (control condition'],"['higher levels of trait SA dampen approach motivation', 'levels of trait SA, social pain', 'social pain']","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0296943,"RESULTS
Analyses revealed that the exclusion condition led to greater social pain than the control condition.","[{'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Hudd', 'Affiliation': 'Department of Psychology and Centre for Mental Health Research and Treatment, University of Waterloo, Canada. Electronic address: thudd@uwaterloo.ca.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Moscovitch', 'Affiliation': 'Department of Psychology and Centre for Mental Health Research and Treatment, University of Waterloo, Canada.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101572']
102,32222613,Remembering happy times instead of sticking to negative memories after social exclusion.,"BACKGROUND & OBJECTIVES
Previous research shows that difficulty disengaging from negative (self-related) stimuli (i.e. negative self-referential processing; NSP) is a vulnerability factor for depression (Gotlib & Joormann, 2010) and contributes to its recurrence (LeMoult, Kircanski, Prasad, & Gotlib, 2017). The Emotional Reversal Learning Task (ERLT) was designed to investigate this, and we examined its construct validity by inducing social rejection, an etiological process of depression, within the ERLT model. We expected excluded participants to have difficulty disengaging from NSP.
METHODS
We administered Cyberball to 130 participants randomly assigned to the excluded or included condition. Participants then completed the ERLT: They chose a valence option (positive or negative), retrieved a memory of the same valence, and then were rewarded or punished for their valence choice. For the first phase, retrieving a negative memory was probabilistically rewarded, and this action-outcome contingency was twice reversed during the task. We used Q-learning models to analyze learning rates.
RESULTS
Excluded participants had no more difficulty disengaging from NSP than included participants: Bayesian computational modeling identified no difference between conditions regarding learning that retrieving negative memories was punished. Exploratory analyses found that excluded participants learned the association between retrieving positive memories and reward quicker than included participants, however.
LIMITATIONS
Doubts remain regarding whether participants fully understood action-outcome contingencies, and we did not explicitly check whether participants truly retrieved memories, which could have affected results.
CONCLUSIONS
We did not find support for the construct validity of the ERLT when using social exclusion to model depressogenic development within the ERLT.",2020,We did not find support for the construct validity of the ERLT when using social exclusion to model depressogenic development within the ERLT.,['130 participants randomly assigned to the excluded or included condition'],['Emotional Reversal Learning Task (ERLT'],[],"[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",[],130.0,0.0369476,We did not find support for the construct validity of the ERLT when using social exclusion to model depressogenic development within the ERLT.,"[{'ForeName': 'M Annelise', 'Initials': 'MA', 'LastName': 'Blanchard', 'Affiliation': 'Center for the Psychology of Learning and Experimental Psychopathology, University of Leuven, Belgium. Electronic address: marie.blanchard@uclouvain.be.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Belmans', 'Affiliation': 'Center for the Psychology of Learning and Experimental Psychopathology, University of Leuven, Belgium.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Takano', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, Ludwig-Maximilians-University Munich, Germany.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Raes', 'Affiliation': 'Center for the Psychology of Learning and Experimental Psychopathology, University of Leuven, Belgium.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101570']
103,32224333,A pilot study augmenting cognitive behavioral therapy for panic disorder with attention bias modification: Clinical and psychophysiological outcomes.,"BACKGROUND AND OBJECTIVES
Studies show that attentional bias towards threat is a key maintenance factor for panic disorder (PD). Attentional bias may be an important mechanism of symptom reduction, and thus, a useful target for optimizing outcomes. The current study examined whether an attention bias modification (ABM) task enhanced CBT outcomes. Multiple methods for assessing PD were used, including physiological measurement and clinician-rated assessment.
METHODS
Adults with panic disorder (N = 24) received seven sessions of CBT with either ABM or sham attention tasks. Psychophysiological reaction to a loud tones startle paradigm was assessed before and after treatment.
RESULTS
Across both groups, panic symptom severity decreased with CBT. The ABM group showed greater reductions in PD symptoms compared to the placebo group. Notably, however, changes in attentional bias were not associated with symptom reductions across groups. No significant group differences on psychophysiological assessment were observed.
LIMITATIONS
This study is limited by the small sample size, which rendered our power to investigate mediators and moderators insufficient. More research is needed to validate the effect of attention bias modification on attentional bias to threat.
CONCLUSIONS
This pilot study suggests that future research should investigate attentional bias in conjunction with CBT. A larger sample would provide opportunity to further investigate the mechanisms through which ABM works, along with potential moderating factors and the use of psychophysiological measurements in panic disorder.",2020,"No significant group differences on psychophysiological assessment were observed.
","['panic disorder with attention bias modification', 'Adults with panic disorder (N\xa0=\xa024']","['CBT with either ABM or sham attention tasks', 'placebo', 'cognitive behavioral therapy']","['Psychophysiological reaction to a loud tones startle paradigm', 'panic symptom severity', 'PD symptoms', 'attentional bias', 'psychophysiological assessment']","[{'cui': 'C0030319', 'cui_str': 'Panic Disorder'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0401351,"No significant group differences on psychophysiological assessment were observed.
","[{'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Baker', 'Affiliation': 'Massachusetts General Hospital, One Bowdoin Square, Boston, MA, 02114, USA; Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA. Electronic address: awbaker@mgh.harvard.edu.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Hellberg', 'Affiliation': 'University of North Carolina Chapel Hill Department of Psychology and Neuroscience, 235 E. Cameron Avenue, Chapel Hill, NC, 27599-3270, USA. Electronic address: shellberg@unc.edu.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Jacoby', 'Affiliation': 'Massachusetts General Hospital, One Bowdoin Square, Boston, MA, 02114, USA; Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA. Electronic address: rjjacoby@mgh.harvard.edu.'}, {'ForeName': 'O M', 'Initials': 'OM', 'LastName': 'Losiewicz', 'Affiliation': 'Massachusetts General Hospital, One Bowdoin Square, Boston, MA, 02114, USA. Electronic address: Naomi.Simon@numc.org.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Orr', 'Affiliation': 'Massachusetts General Hospital, One Bowdoin Square, Boston, MA, 02114, USA; Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA. Electronic address: scott_orr@hms.harvard.edu.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Marques', 'Affiliation': 'Massachusetts General Hospital, One Bowdoin Square, Boston, MA, 02114, USA; Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA. Electronic address: lmarques@mgh.harvard.edu.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Massachusetts General Hospital, One Bowdoin Square, Boston, MA, 02114, USA; Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA; New York University Langone Health Department of Psychiatry, One Park Avenue, 8th floor, New York, NY, 10016, USA. Electronic address: Naomi.Simon@numc.org.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101568']
104,31733608,Establishing the dose of memory support to improve patient memory for treatment and treatment outcome.,"BACKGROUND AND OBJECTIVES
Patient memory for the contents of treatment sessions is poor and this is associated with worse treatment outcome. Preliminary findings indicate that treatment provider use of memory support can be helpful in enhancing patient memory for treatment and improving outcome. The development of a novel Memory Support Intervention is currently underway. A key step in this process is to establish the dose of memory support that treatment providers deliver in treatment-as-usual, as well as the optimal dose of memory support needed to maximize patient memory for treatment points and outcomes.
METHODS
Forty-two adults with major depressive disorder (MDD) were randomized to receive either cognitive therapy plus memory support (CS + Memory Support; n = 22) or cognitive therapy as-usual (CT-as-usual; n = 20). Patients completed a free recall of treatment points task at post-treatment. Outcome measures were administered at baseline and post-treatment.
RESULTS
Treatment providers delivering CT-as-usual used, on average, 8.39 instances of memory support and 3.40 different types of memory support per session. Receiver Operating Characteristics (ROC) analyses using the combined sample indicate that 12.45 instances of memory support and 3.88 to 4.13 different types of memory support are needed to maximize patient recall and functional outcome.
LIMITATIONS
Dosing recommendations were established using a limited sample of participants receiving cognitive therapy for MDD.
CONCLUSIONS
Treatment providers appear to deliver a suboptimal amount of memory support. Delivering the optimal dose of memory support could improve treatment outcome.",2020,"RESULTS
Treatment providers delivering CT-as-usual used, on average, 8.39 instances of memory support and 3.40 different types of memory support per session.","['participants receiving cognitive therapy for MDD', 'Forty-two adults with major depressive disorder (MDD']",['cognitive therapy plus memory support (CS\xa0+\xa0Memory Support; n\u202f=\u202f22) or cognitive therapy as-usual (CT-as-usual; n\u202f=\u202f20'],[],"[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],42.0,0.0491982,"RESULTS
Treatment providers delivering CT-as-usual used, on average, 8.39 instances of memory support and 3.40 different types of memory support per session.","[{'ForeName': 'Jason Y', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'University of California, Berkeley, Department of Psychology, 2121 Berkeley Way #1650, Berkeley, CA, 94720-1650, USA. Electronic address: jaylee24@gmail.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'University of California, Berkeley, Department of Psychology, 2121 Berkeley Way #1650, Berkeley, CA, 94720-1650, USA. Electronic address: donglu0305@gmail.com.'}, {'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Gumport', 'Affiliation': 'University of California, Berkeley, Department of Psychology, 2121 Berkeley Way #1650, Berkeley, CA, 94720-1650, USA. Electronic address: ngumport@berkeley.edu.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'University of California, Berkeley, Department of Psychology, 2121 Berkeley Way #1650, Berkeley, CA, 94720-1650, USA. Electronic address: aharvey@berkeley.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101526']
105,31734573,Investigating the therapeutic potential of cognitive bias modification for high anxiety sensitivity.,"BACKGROUND AND OBJECTIVES
Individuals with high anxiety sensitivity (AS) display negative interpretive biases in response to uncomfortable but nondangerous physical sensations. Research suggests that modifying interpretation biases associated with AS leads to changes in AS. The present study sought to replicate and extend this research by addressing limitations of previous studies, increasing the amount of training and adding a follow-up period.
METHOD
Participants high in AS were randomly assigned to four sessions of computerized interpretation bias modification (CBM-I) training or four sessions of computerized ""sham"" training (control condition) over a 2-week period. The outcomes were AS, interpretive biases, and reactions to induced physical sensations. Assessments occurred at baseline, during training, immediately after the final training session, and 2 weeks after the final training; number of re-assessments varied by outcome.
RESULTS
The CBM-I condition did not outperform the control condition. At the end of the training period, the CBM-I condition displayed limited reductions in AS and interpretation biases. There were no changes in reactions to induced physical sensations. Similar results were found in the control condition for all outcomes.
LIMITATIONS
The control task and the dose of training may have obscured potential effects of CBM-I.
CONCLUSIONS
When considered within the context of previous research, the experimental effects and therapeutic potential of CBM-I for high AS appear to be minimal. However, methodological questions need to be resolved before such a conclusion can be considered definitive.",2020,The CBM-I condition did not outperform the control condition.,"['Individuals with high anxiety sensitivity (AS', 'Participants high in AS']","['computerized interpretation bias modification (CBM-I) training or four sessions of computerized ""sham"" training (control condition']","['AS, interpretive biases, and reactions to induced physical sensations', 'reactions to induced physical sensations']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]","[{'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}]",,0.0146785,The CBM-I condition did not outperform the control condition.,"[{'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'MacDonald', 'Affiliation': 'Department of Psychology, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Koerner', 'Affiliation': 'Department of Psychology, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada. Electronic address: naomi.koerner@psych.ryerson.ca.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Antony', 'Affiliation': 'Department of Psychology, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Vickers', 'Affiliation': 'Department of Psychology, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada.'}, {'ForeName': 'Tessie', 'Initials': 'T', 'LastName': 'Mastorakos', 'Affiliation': 'Department of Psychology, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Kuo', 'Affiliation': 'Department of Psychology, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101521']
106,31951819,"D-cycloserine as adjunct to brief computerised CBT for spider fear: Effects on fear, behaviour, and cognitive biases.","BACKGROUND AND OBJECTIVES
In anxiety disorders, cognitive behavioural therapy (CBT) improves information-processing biases such as implicit fear evaluations and avoidance tendencies, which predicts treatment response. Thus, these cognitive biases might constitute important treatment targets. This study investigated (i) whether information-processing biases could be changed following single-session computerised CBT for spider fear, and (ii) whether this effect could be augmented by administration of D-cycloserine (DCS).
METHODS
Spider-fearful individuals were randomized to receiving either 250 mg of DCS (n = 21) or placebo (n = 17). Three hours after drug administration, they received single-session computerized CBT, characterized by psychoeducation and exposure elements. Spider fear was assessed using self-report, behavioural, and information processing (Extrinsic Affective Simon Task & Approach Avoidance Task) measures at baseline (before drug administration), post-treatment, 1-day, and 1-month follow-up.
RESULTS
Linear mixed-effects analyses indicated significant improvements on self-report and behavioural spider fear indices following CBT, but not on cognitive bias measures. There was no evidence of an augmentation effect of DCS on any outcome. Cognitive bias measures at 1-day were not predictive of 1-month follow-up spider fear in adjusted linear regression analyses.
LIMITATIONS
Results might be biased by limited representativeness of the sample (high education and intelligence, largely Caucasian ethnicity, young age). The study was also only powered for detection of medium-sized DCS effects.
CONCLUSIONS
These findings do not provide evidence for information-processing biases relating to treatment outcome following computerised CBT for spider fear or augmentation with DCS.",2020,These findings do not provide evidence for information-processing biases relating to treatment outcome following computerised CBT for spider fear or augmentation with DCS.,['Spider-fearful individuals'],"['cognitive behavioural therapy (CBT', 'DCS', 'placebo', '250\xa0mg of DCS']","['fear, behaviour, and cognitive biases', 'self-report and behavioural spider fear indices', 'self-report, behavioural, and information processing (Extrinsic Affective Simon Task & Approach Avoidance Task) measures', 'Cognitive bias measures']","[{'cui': 'C0037913', 'cui_str': 'Spiders'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0037913', 'cui_str': 'Spiders'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0595947', 'cui_str': 'Extrinsic (qualifier value)'}, {'cui': 'C0443058', 'cui_str': 'Simon (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0560813,These findings do not provide evidence for information-processing biases relating to treatment outcome following computerised CBT for spider fear or augmentation with DCS.,"[{'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kappelmann', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK; Max Planck Institute of Psychiatry, Munich, Germany; International Max Planck Research School for Translational Psychiatry (IMPRS-TP), Munich, Germany.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Suesse', 'Affiliation': 'Oxford Institute of Clinical Psychology Doctorate Training, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Steudte-Schmiedgen', 'Affiliation': 'Department of Psychotherapy and Psychosomatic Medicine, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Reinoud', 'Initials': 'R', 'LastName': 'Kaldewaij', 'Affiliation': 'Donders Institute for Brain, Cognition, and Behaviour, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Browning', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK; Oxford Health NHS Trust, Oxford, UK.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Michael', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Rinck', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reinecke', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK. Electronic address: andrea.reinecke@psych.ox.ac.uk.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101546']
107,32062021,"The effect of Instagram #fitspiration images on young women's mood, body image, and exercise behaviour.","The present study experimentally examined the effects of viewing Instagram images of fitspiration on body dissatisfaction, mood, and exercise behaviour among young women. Further, the study investigated if exercise engagement following exposure to fitspiration images could mitigate any negative effects from image exposure. Participants were 108 women, aged 17-25 years, who were randomly assigned to a 2 (image type: fitspiration, travel inspiration) × 2 (activity type: exercise, quiet rest) between groups design. State body dissatisfaction and mood were assessed at baseline, following image exposure, and following participation in 10 min of walking or quiet rest. Results demonstrated that exposure to fitspiration images led to significantly higher negative mood and body dissatisfaction relative to exposure to travel images. There was no difference in actual exercise behaviour according to image type. However, participants who exercised following exposure to fitspiration images were significantly more likely to report higher subjective exertion ratings. Overall, negative mood and body dissatisfaction decreased after both exercise and quiet rest, with no additional benefit of exercise for the fitspiration condition. These findings provide further evidence highlighting fitspiration as a potentially harmful online trend.",2020,"Overall, negative mood and body dissatisfaction decreased after both exercise and quiet rest, with no additional benefit of exercise for the fitspiration condition.","[""young women's mood, body image, and exercise behaviour"", 'Participants were 108 women, aged 17-25 years', 'young women']","['2 (image type: fitspiration, travel inspiration']","['actual exercise behaviour', 'body dissatisfaction, mood, and exercise behaviour', 'Overall, negative mood and body dissatisfaction', 'subjective exertion ratings']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0429689', 'cui_str': 'Exertion rating (staging scale)'}]",108.0,0.0528909,"Overall, negative mood and body dissatisfaction decreased after both exercise and quiet rest, with no additional benefit of exercise for the fitspiration condition.","[{'ForeName': 'Ivanka', 'Initials': 'I', 'LastName': 'Prichard', 'Affiliation': 'Health & Exercise Sciences, College of Nursing & Health Sciences, Flinders University, Adelaide, South Australia, Australia; SHAPE Research Centre, Flinders University, Adelaide, South Australia, Australia. Electronic address: ivanka.prichard@flinders.edu.au.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Kavanagh', 'Affiliation': 'Psychology, College of Education, Psychology & Social Work, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Maroochydore, Australia.'}, {'ForeName': 'Megan S C', 'Initials': 'MSC', 'LastName': 'Lim', 'Affiliation': 'Burnet Institute, 85 Commercial Rd, Melbourne, Australia; School of Population Health and Preventive Medicine, Monash University, Melbourne, Australia; Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'Psychology, College of Education, Psychology & Social Work, Flinders University, Adelaide, South Australia, Australia.'}]",Body image,['10.1016/j.bodyim.2020.02.002']
108,32155470,Effects of the video game 'Mindlight' on anxiety of children with an autism spectrum disorder: A randomized controlled trial.,"BACKGROUND AND OBJECTIVES
In the clinical setting, a large proportion of children with an autism spectrum disorder (ASD) experience impairing anxiety symptoms. Recently, an applied videogame called Mindlight has been developed that focuses on decreasing anxiety in children. The present study involved a randomized controlled trial (RCT) investigating the effect of Mindlight on (sub)clinical anxiety symptoms in children with an ASD.
METHODS
In total, 109 children of 8-16 years old with an ASD and (sub)clinical anxiety symptoms were randomly assigned to the experimental (N = 53) or the control (N = 56) condition. Children in the experimental condition played Mindlight, children in the control condition played a commercial game (Triple Town) for 1 h per week, for six consecutive weeks. All children and parents completed assessments at baseline, post-intervention and 3-months follow-up.
RESULTS
Results showed no differences in decrease of child-rated anxiety symptoms between both conditions. However, the decrease of parent-rated anxiety symptoms was significantly larger in the experimental condition.
LIMITATIONS
Mechanisms of change associated with treatment outcomes were not investigated in the present study. Therefore, it remains unclear which specific or non-specific factors contributed to the decrease in anxiety symptoms in both conditions.
CONCLUSIONS
The present study provided some preliminary evidence that video games are a promising new intervention vehicle for children with an ASD and anxiety, at least according to parents. However, further research on working mechanisms is needed, in order to specify to what extent and for which children with ASD Mindlight could be an effective anxiety treatment.",2020,"RESULTS
Results showed no differences in decrease of child-rated anxiety symptoms between both conditions.","['children with an autism spectrum disorder', 'children with an ASD and anxiety, at least according to parents', 'children', 'children with an ASD', 'children with an autism spectrum disorder (ASD) experience impairing anxiety symptoms', '109 children of 8-16 years old with an ASD and (sub)clinical anxiety symptoms']","[""video game 'Mindlight"", 'Mindlight']","['parent-rated anxiety symptoms', 'anxiety symptoms', 'child-rated anxiety symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",109.0,0.105935,"RESULTS
Results showed no differences in decrease of child-rated anxiety symptoms between both conditions.","[{'ForeName': 'Lieke A M W', 'Initials': 'LAMW', 'LastName': 'Wijnhoven', 'Affiliation': 'Mental Health Care Institute GGZ Oost-Brabant, P.O. Box 3, 5427, ZG, Boekel, the Netherlands; Behavioural Science Institute, Radboud University, P.O. Box 9104, 6500, HE, Nijmegen, the Netherlands. Electronic address: l.wijnhoven@pwo.ru.nl.'}, {'ForeName': 'Daan H M', 'Initials': 'DHM', 'LastName': 'Creemers', 'Affiliation': 'Mental Health Care Institute GGZ Oost-Brabant, P.O. Box 3, 5427, ZG, Boekel, the Netherlands; Behavioural Science Institute, Radboud University, P.O. Box 9104, 6500, HE, Nijmegen, the Netherlands. Electronic address: d.creemers@ggzoostbrabant.nl.'}, {'ForeName': 'Ad A', 'Initials': 'AA', 'LastName': 'Vermulst', 'Affiliation': 'Mental Health Care Institute GGZ Oost-Brabant, P.O. Box 3, 5427, ZG, Boekel, the Netherlands. Electronic address: a.vermulst@home.nl.'}, {'ForeName': 'Ramón J L', 'Initials': 'RJL', 'LastName': 'Lindauer', 'Affiliation': 'Mental Health Care Institute De Bascule, P.O. Box 303, 1115, ZG, Duivendrecht, the Netherlands; Faculty of Medicine, University of Amsterdam, P.O. Box 22660, 1100, DD, Amsterdam, the Netherlands. Electronic address: r.lindauer@debascule.com.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Otten', 'Affiliation': 'Behavioural Science Institute, Radboud University, P.O. Box 9104, 6500, HE, Nijmegen, the Netherlands; Mental Health Care Institute Pluryn, P.O. Box 53, 6500, AB, Nijmegen, the Netherlands; Arizona State University, REACH Institute, P.O. Box 876005, Tempe, AZ, USA. Electronic address: royotten@pluryn.nl.'}, {'ForeName': 'Rutger C M E', 'Initials': 'RCME', 'LastName': 'Engels', 'Affiliation': 'Erasmus University, Erasmus School of Social and Behavioral Sciences, P.O. Box 1738, 3000, DR, Rotterdam, the Netherlands. Electronic address: rutger.engels@eur.nl.'}, {'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Granic', 'Affiliation': 'Behavioural Science Institute, Radboud University, P.O. Box 9104, 6500, HE, Nijmegen, the Netherlands. Electronic address: i.granic@pwo.ru.nl.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101548']
109,32330548,Motivational interviewing to prevent early childhood caries: A randomized controlled trial.,"OBJECTIVES
Prevailing health education (PE) often fails to achieve sustained behavioral changes. This randomized controlled trial integrated motivational interviewing (MI) and a patient communication tool featuring interactive caries risk assessment (RA) into PE and investigated the effectiveness of PE, PE + MI, and PE + MI + RA in preventing early childhood caries.
METHODS
This study targeted children aged 3-4 years with unfavorable oral health behaviors. 692 parent-child dyads were recruited, randomly assigned into three groups (PE, PE + MI, and PE + MI + RA), and received respective interventions. A questionnaire was completed at baseline and after 6 and 12 months to collect information on socio-demographic background, parental efficacy and children's oral health behaviors. Children's oral hygiene status and dental caries were recorded at baseline and after 12 months.
RESULTS
655 (94.7%) parent-child dyads remained in the study after 12 months. Caries increment was significantly lower in PE + MI group (β=-0.717, 95% CI: -1.035, -0.398) and PE + MI + RA group [β=-0.600, 95% CI: -0.793, -0.407] than in PE group. There was significantly greater reduction in plaque score in PE + MI group (β=-0.077, 95% CI: -0.106, -0.048) and PE + MI + RA group (β=-0.075, 95% CI: -0.113, -0.036), as compared with PE group. Significantly greater improvements were found in parental efficacy and children's oral health behaviors in PE + MI and PE + MI + RA groups than in PE group (all p < 0.05). There was no significant difference between PE + MI group and PE + MI + RA group across all outcome measures (all p > 0.05).
CONCLUSIONS
Intergration of motivational interviewing improves the effectiveness of prevailing health education in preventing early childhood caries, enhancing parental efficacy, and improving children's oral health behaviors. Incorporation of the communication tool for caries risk assessment does not further improve the effectiveness of motivational interviewing in protecting children's oral health.
CLINICAL SIGNIFICANCE
The findings of this study provide much needed evidence for dentists, dental auxiliary staff and public health workers to select effective intervention to empower parents for improving children's oral health behaviors and preventing early childhood caries.",2020,Significantly greater improvements were found in parental efficacy and children's oral health behaviors in PE + MI and PE + MI + RA groups than in PE group (all p < 0.05).,"['early childhood caries', '692 parent-child dyads', '655', 'children aged 3-4 years with unfavorable oral health behaviors']","['PE, PE\u2009+\u2009MI, and PE\u2009+\u2009MI\u2009+\u2009RA', 'motivational interviewing (MI) and a patient communication tool featuring interactive caries risk assessment (RA) into PE', 'Motivational interviewing']","[""Children's oral hygiene status and dental caries"", ""parental efficacy and children's oral health behaviors"", 'Caries increment', ""children's oral health behaviors"", 'plaque score']","[{'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C3152857', 'cui_str': 'Prevail'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4082459', 'cui_str': 'Oral hygiene status'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0564415,Significantly greater improvements were found in parental efficacy and children's oral health behaviors in PE + MI and PE + MI + RA groups than in PE group (all p < 0.05).,"[{'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Colman', 'Initials': 'C', 'LastName': 'McGrath', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Edward Cm', 'Initials': 'EC', 'LastName': 'Lo', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Samuel My', 'Initials': 'SM', 'LastName': 'Ho', 'Affiliation': 'Department of Social and Behavioural Sciences, City University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Faculty of Dentistry & Saw Swee Hock School of Public Health, National University of Singapore, Singapore. Electronic address: dengx@nus.edu.sg.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103349']
110,32330594,Pilot study of combined aerobic and resistance exercise on fatigue for patients with head and neck cancer: Inflammatory and epigenetic changes.,"This pilot study examined whether a combined aerobic resistance exercise program reduced fatigue and the potential inflammatory and epigenetic mechanisms in patients with head and neck cancer (HNC) receiving intensity-modulated radiotherapy. The exercise group (N = 12) received a 3-month supervised aerobic resistance exercise intervention that was initiated before a 6-week radiotherapy regimen; the control group (N = 14) received standard care. Fatigue was measured using Multidimensional Fatigue Inventory-20; physical function measures included a 6-minute walk distance (6MWD), chair stands, bicep curls, and hand grip strength. Inflammatory markers and DNA methylation data were acquired using standardized protocol. Patients were mostly white (93%) and male (81%) with a mean age of 57 years. At the end of the intervention, the exercise group had a marginal decrease in fatigue compared with the control (-5.0 vs. 4.9; P = 0.10). The exercise group had a significantly greater improvement in 6MWD (29.8 vs. -55.5 m; P = 0.04), and a marginally smaller decline in hand grip (-0.3 vs. -5.8 lbs; P = 0.05) at the end of the intervention than the control. No significant difference in inflammatory markers was observed between groups. Lower plasma interleukin (IL) 6, IL1 receptor antagonist, tumor necrosis factor α (TNFα), soluble TNF receptor II and C-reactive protein were significantly associated with increased 6MWD, chair stand, and bicep curl at the end of the intervention (p < 0.05). Among the 1152 differentially methylated sites (DMS) after intervention (p < 0.001), 163 DMS were located in gene promoter regions. Enrichment analysis suggested that the top 10 upstream regulators were associated with tumor (HNF4A, RPP38, HOXA9, SAHM1, CDK7, NDN, RPS15) and inflammation (IRF7, CRKL, ONECUT1). The top 5 diseases or functions annotations of the 62 hypermethylated DMS indicated anti-tumor and anti-inflammatory effects that might be linked to exercise. These findings suggest that exercise may improve physical performance and reduce fatigue, which could be further linked to decreased inflammation, during active radiotherapy for HNC patients. Larger studies are warranted.",2020,"Lower plasma interleukin (IL) 6, IL1 receptor antagonist, tumor necrosis factor α (TNFα), soluble TNF receptor II and C-reactive protein were significantly associated with increased 6MWD, chair stand, and bicep curl at the end of the intervention (p<0.05).","['Patients were mostly white (93%) and male (81%) with a mean age of 57 years', 'Patients with Head and Neck Cancer', 'patients with head and neck cancer (HNC) receiving intensity-modulated radiotherapy']","['supervised aerobic resistance exercise intervention', 'Combined Aerobic and Resistance Exercise', 'combined aerobic resistance exercise program', 'standard care']","['6MWD, chair stand, and bicep curl', '6-minute walk distance (6MWD), chair stands, bicep curls, and hand grip strength', 'inflammatory markers', 'Lower plasma interleukin (IL) 6, IL1 receptor antagonist, tumor necrosis factor α (TNFα), soluble TNF receptor II and C-reactive protein', 'fatigue and the potential inflammatory and epigenetic mechanisms', 'Fatigue', '6MWD', 'physical performance and reduce fatigue', 'fatigue', 'tumor (HNF4A, RPP38, HOXA9, SAHM1, CDK7, NDN, RPS15) and inflammation (IRF7, CRKL, ONECUT1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0063710', 'cui_str': 'Interleukin 1 Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1516924', 'cui_str': 'Epigenetic Process'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0386322', 'cui_str': 'Hoxa9 protein'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1530281', 'cui_str': 'IRF7 protein, human'}, {'cui': 'C0219488', 'cui_str': 'CRKL protein'}]",163.0,0.0291941,"Lower plasma interleukin (IL) 6, IL1 receptor antagonist, tumor necrosis factor α (TNFα), soluble TNF receptor II and C-reactive protein were significantly associated with increased 6MWD, chair stand, and bicep curl at the end of the intervention (p<0.05).","[{'ForeName': 'Canhua', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'School of Nursing, Yale University, 400 West Campus Drive, Orange 06477, United States. Electronic address: canhua.xiao@yale.edu.'}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Beitler', 'Affiliation': 'Department of Radiation, School of Medicine, Emory University, 1520 Clifton Road NE, Atlanta 30322, United States.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Higgins', 'Affiliation': 'Department of Radiation, School of Medicine, Emory University, 1520 Clifton Road NE, Atlanta 30322, United States.'}, {'ForeName': 'Cynthia E', 'Initials': 'CE', 'LastName': 'Chico', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, 1365-B Clifton Road, Atlanta, GA 30322, United States.'}, {'ForeName': 'Janice S', 'Initials': 'JS', 'LastName': 'Withycombe', 'Affiliation': ""School of Nursing, Clemson University, 508 Edward's, Clemson, SC 29634, United States.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Medical Neurobiology and MOE Frontier Center for Brain Science, Institutes of Brain Science, Fudan University, Shanghai 200433, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Epidemiology and Public Health, School of Medicine, Yale University, 300 George Street, New Haven, CT 06510, United States.'}, {'ForeName': 'I-Hsin', 'Initials': 'IH', 'LastName': 'Lin', 'Affiliation': 'Yale Center for Analytical Sciences, School of Public Health, Yale University, 300 George Street, New Haven, CT 06510, United States.'}, {'ForeName': 'Fangyong', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'School of Public Health, Yale University, 60 College St, New Haven, CT 06510, United States.'}, {'ForeName': 'Sangchoon', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': 'School of Nursing, Yale University, 400 West Campus Drive, Orange 06477, United States.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Irwin', 'Affiliation': 'School of Public Health, Yale University, 60 College St, New Haven, CT 06510, United States.'}, {'ForeName': 'Deborah W', 'Initials': 'DW', 'LastName': 'Bruner', 'Affiliation': 'School of Nursing, Emory University, 1520 Clifton Road NE, Atlanta 30322, United States.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, 1365-B Clifton Road, Atlanta, GA 30322, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gary', 'Affiliation': 'School of Nursing, Emory University, 1520 Clifton Road NE, Atlanta 30322, United States.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.04.044']
111,32329438,Enhancing Patient Activation and Self-Management Activities in Patients With Type 2 Diabetes Using the US Department of Defense Mobile Health Care Environment: Feasibility Study.,"BACKGROUND
Past mobile health (mHealth) efforts to empower type 2 diabetes (T2D) self-management include portals, text messaging, collection of biometric data, electronic coaching, email, and collection of lifestyle information.
OBJECTIVE
The primary objective was to enhance patient activation and self-management of T2D using the US Department of Defense's Mobile Health Care Environment (MHCE) in a patient-centered medical home setting.
METHODS
A multisite study, including a user-centered design and a controlled trial, was conducted within the US Military Health System. Phase I assessed preferences regarding the enhancement of the enabling technology. Phase II was a single-blinded 12-month feasibility study that randomly assigned 240 patients to either the intervention (n=123, received mHealth technology and behavioral messages tailored to Patient Activation Measure [PAM] level at baseline) or the control group (n=117, received equipment but not messaging. The primary outcome measure was PAM scores. Secondary outcome measures included Summary of Diabetes Self-Care Activities (SDSCA) scores and cardiometabolic outcomes. We used generalized estimating equations to estimate changes in outcomes.
RESULTS
The final sample consisted of 229 patients. Participants were 61.6% (141/229) male, had a mean age of 62.9 years, mean glycated hemoglobin (HbA 1c ) of 7.5%, mean BMI of 32.7, and a mean duration of T2D diagnosis of 9.8 years. At month 12, the control group showed significantly greater improvements compared with the intervention group in PAM scores (control mean 7.49, intervention mean 1.77; P=.007), HbA 1c (control mean -0.53, intervention mean -0.11; P=.006), and low-density lipoprotein cholesterol (control mean -7.14, intervention mean 4.38; P=.01). Both groups showed significant improvement in SDSCA, BMI, waist size, and diastolic blood pressure; between-group differences were not statistically significant. Except for patients with the highest level of activation (PAM level 4), intervention group patients exhibited significant improvements in PAM scores. For patients with the lowest level of activation (PAM level 1), the intervention group showed significantly greater improvement compared with the control group in HbA 1c (control mean -0.09, intervention mean -0.52; P=.04), BMI (control mean 0.58, intervention mean -1.22; P=.01), and high-density lipoprotein cholesterol levels (control mean -4.86, intervention mean 3.56; P<.001). Significant improvements were seen in AM scores, SDSCA, and waist size for both groups and in diastolic and systolic blood pressure for the control group; the between-group differences were not statistically significant. The percentage of participants who were engaged with MHCE for ≥50% of days period was 60.7% (68/112; months 0-3), 57.4% (62/108; months 3-6), 49.5% (51/103; months 6-9), and 43% (42/98; months 9-12).
CONCLUSIONS
Our study produced mixed results with improvement in PAM scores and outcomes in both the intervention and control groups. Structural design issues may have hampered the influence of tailored behavioral messaging within the intervention group.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02949037; https://clinicaltrials.gov/ct2/show/NCT02949037.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.2196/resprot.6993.",2020,"At month 12, the control group saw significantly greater improvements compared to the intervention group in PAM® score (control mean: 7.49, intervention mean: 1.77; P=.007), HbA1c (control mean:","['participants had mean age of 62.8 years, mean HbA1c of 7.5', 'Patients with Type 2 Diabetes using the U.S. Department of Defense Mobile Health Care Environment', '240 patients to either the']","['MHCE intervention (n=123, received enabling mHealth technology and behavioral messages tailored to Patient Activation Measure® (PAM®) level at baseline or the control group (n=117, received equipment but not behavioral messaging, ""intervention-lite']","['PAM® scores', 'PAM® score', 'BMI', 'Summary of Diabetes Self-care Activities (SDSCA) scores and cardiometabolic outcomes', 'HDL cholesterol levels', 'LDL cholesterol (control mean', 'PAM® score, SDSCA, and waist size for both groups, and diastolic and systolic blood pressure', 'SDSCA, BMI, waist size, and diastolic blood pressure']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0557735', 'cui_str': 'Caring environment'}, {'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0557735', 'cui_str': 'Caring environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C2931826', 'cui_str': 'Potassium aggravated myotonia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C2931826', 'cui_str': 'Potassium aggravated myotonia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",240.0,0.02861,"At month 12, the control group saw significantly greater improvements compared to the intervention group in PAM® score (control mean: 7.49, intervention mean: 1.77; P=.007), HbA1c (control mean:","[{'ForeName': 'Ronald W', 'Initials': 'RW', 'LastName': 'Gimbel', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Lior M', 'Initials': 'LM', 'LastName': 'Rennert', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Crawford', 'Affiliation': ""Nellis Family Medicine Residency Program, Mike O'Callaghan Federal Hospital, Las Vegas, NV, United States.""}, {'ForeName': 'Jeanette R', 'Initials': 'JR', 'LastName': 'Little', 'Affiliation': 'Mobile Health Innovation Center, Telemedicine & Advanced Technologies Research Center, U.S. Army Medical Research & Materials Command, Fort Gordon, GA, United States.'}, {'ForeName': 'Khoa', 'Initials': 'K', 'LastName': 'Truong', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Williams', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Sarah F', 'Initials': 'SF', 'LastName': 'Griffin', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Fielding School of Public Health, University of California Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'LingLing', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, United States.'}, {'ForeName': 'Jennie B', 'Initials': 'JB', 'LastName': 'Moss', 'Affiliation': ""Nellis Family Medicine Residency Program, Mike O'Callaghan Federal Hospital, Las Vegas, NV, United States.""}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Marshall', 'Affiliation': 'Clinical Informatics Fellowship Program, Madigan Army Medical Center, Tacoma, WA, United States.'}, {'ForeName': 'Karen W', 'Initials': 'KW', 'LastName': 'Edwards', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Kristy J', 'Initials': 'KJ', 'LastName': 'Crawford', 'Affiliation': ""Nellis Family Medicine Residency Program, Mike O'Callaghan Federal Hospital, Las Vegas, NV, United States.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hing', 'Affiliation': 'Department of Internal Medicine, Madigan Army Medical Center, Tacoma, WA, United States.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Schmeltz', 'Affiliation': 'Mobile Health Innovation Center, Telemedicine & Advanced Technologies Research Center, U.S. Army Medical Research & Materials Command, Fort Gordon, GA, United States.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Lumsden', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Ashby', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Haas', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Palazzo', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC, United States.'}]",Journal of medical Internet research,['10.2196/17968']
112,32326304,A Pilot Randomised Clinical Trial of a Novel Approach to Reduce Sedentary Behaviour in Care Home Residents: Feasibility and Preliminary Effects of the GET READY Study.,"Care-home residents are among the most sedentary and least active of the population. We aimed to assess the feasibility, acceptability, safety, and preliminary effects of an intervention to reduce sedentary behaviour (SB) co-created with care home residents, staff, family members, and policymakers within a pilot two-armed pragmatic cluster randomized clinical trial (RCT). Four care homes from two European countries participated, and were randomly assigned to control (usual care, CG) or the Get Ready intervention (GR), delivered by a staff champion one-to-one with the care home resident and a family member. A total of thirty-one residents participated (51.6% female, 82.9 (13.6) years old). GR involves six face to face sessions over a 12-week period with goal-oriented prompts for movement throughout. The feasibility and acceptability of the intervention were assessed and adverse events (AEs) were collected. The preliminary effects of the GR on SB, quality of life, fear of falling, and physical function were assessed. Means and standard deviations are presented, with the mean change from baseline to post-intervention calculated along with 95% confidence intervals. The CG smoked more, sat more, and had more functional movement difficulties than the GR at baseline. The GR intervention was feasible and acceptable to residents and staff. No AEs occurred during the intervention. GR participants showed a decrease in daily hours spent sitting/lying (Cohen's d = 0.36) and an increase in daily hours stepping, and improvements in health-related quality of life, fear of falling, and habitual gait speed compared to usual care, but these effects need confirmation in a definitive RCT. The co-created GR was shown to be feasible and acceptable, with no AEs.",2020,"GR participants showed a decrease in daily hours spent sitting/lying (Cohen's d = 0.36) and an increase in daily hours stepping, and improvements in health-related quality of life, fear of falling, and habitual gait speed compared to usual care, but these effects need confirmation in a definitive RCT.","['Sedentary Behaviour in Care Home Residents', 'Four care homes from two European countries participated', 'A total of thirty-one residents participated (51.6% female, 82.9 (13.6) years old']","['control (usual care, CG) or the Get Ready intervention (GR), delivered by a staff champion one-to-one with the care home resident and a family member', 'GR intervention']","['sedentary behaviour (SB', 'daily hours spent sitting/lying', 'feasibility, acceptability, safety', 'SB, quality of life, fear of falling, and physical function', 'functional movement difficulties', 'daily hours stepping, and improvements in health-related quality of life, fear of falling, and habitual gait speed']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",31.0,0.0546158,"GR participants showed a decrease in daily hours spent sitting/lying (Cohen's d = 0.36) and an increase in daily hours stepping, and improvements in health-related quality of life, fear of falling, and habitual gait speed compared to usual care, but these effects need confirmation in a definitive RCT.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Giné-Garriga', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow G4 0BA, UK.'}, {'ForeName': 'Philippa M', 'Initials': 'PM', 'LastName': 'Dall', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow G4 0BA, UK.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Sandlund', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Umeå University, 901 87 Umeå, Sweden.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Jerez-Roig', 'Affiliation': 'Research Group on Methodology, Methods, Models and Outcome of Health and Social Sciences (M3O), Faculty of Health Sciences and Welfare, University of Vic-Central University of Catalonia (UVIC-UCC), 08500 Vic, Spain.'}, {'ForeName': 'Sebastien F M', 'Initials': 'SFM', 'LastName': 'Chastin', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow G4 0BA, UK.'}, {'ForeName': 'Dawn A', 'Initials': 'DA', 'LastName': 'Skelton', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow G4 0BA, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17082866']
113,32327444,High or low glycemic index (GI) meals at dinner results in greater postprandial glycemia compared with breakfast: a randomized controlled trial.,"INTRODUCTION
While circadian control of glucose metabolism is well known, how glycemic index (GI) of carbohydrate-rich meals interacts with time of consumption (breakfast or dinner) to influence postprandial (PP) glucose homeostasis is less well established. The objective of the study was to assess markers of PP glucose homeostasis following high or low GI test meals (TM) consumed either at breakfast or at dinner and following consumption of the subsequent standardized meals (SSM).
RESEARCH DESIGN AND METHODS
Randomized crossover trial in 34 healthy, Chinese, elderly volunteers (mean±SEM age, 56.8±0.83 years), who completed 4 separate study sessions per-protocol, consisting of a high-GI breakfast, low-GI breakfast, high-GI dinner and low-GI dinner TM, followed by a SSM at the subsequent eating occasion. Blood samples were taken for 3 hours after each TM and SSM for glucose, insulin, glucagon, free fatty acids (FFA) and triglycerides (TG) measurements.
RESULTS
Consuming TM at dinner produced greater PP glycemia than breakfast both after TM and SSM (both p<0.0001), irrespective of GI. High-GI TM also produced greater PP glycemia than low-GI TM, both after TM and SSM (both p<0.01), irrespective of time of consumption. No interaction between GI and time were found on PP glycemia, indicating parallel, but independent effects. Combined total areas under the curve of TM+SSM for PP glucose (p<0.0001), PP TG (p<0.0001) and PP FFA (p<0.0001) were all greater when TM taken during dinner compared with breakfast.
CONCLUSIONS
Carbohydrate-rich meals consumed at dinner leads to significantly worse PP glucose homeostasis than when consumed at breakfast, on top of the independent GI effect of the meal. This may have implications to future type 2 diabetes risk. Moreover, future studies investigating GI/glycemic load (GL) and disease risk associations should factor in timing of GL consumption as an additional variable.
TRIAL REGISTRATION NUMBER
NCT02927600.",2020,"Combined total areas under the curve of TM+SSM for PP glucose (p<0.0001), PP TG (p<0.0001) and PP FFA (p<0.0001) were all greater when TM taken during dinner compared with breakfast.
","['34 healthy, Chinese, elderly volunteers (mean±SEM\u2009age, 56.8±0.83 years), who completed 4 separate study sessions per-protocol, consisting of a high-GI breakfast, low-GI breakfast, high-GI dinner and low-GI dinner TM, followed by a SSM at the subsequent eating occasion']","['high or low GI test meals (TM) consumed either at breakfast or at dinner and following consumption of the subsequent standardized meals (SSM', 'TM and SSM ', 'High-GI TM', 'High or low glycemic index (GI) meals']","['postprandial glycemia', 'PP glycemia', 'PP glucose homeostasis', 'glucose, insulin, glucagon, free fatty acids (FFA) and triglycerides (TG) measurements', 'curve of TM+SSM for PP glucose (p<0.0001), PP TG (p<0.0001) and PP FFA']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",34.0,0.216708,"Combined total areas under the curve of TM+SSM for PP glucose (p<0.0001), PP TG (p<0.0001) and PP FFA (p<0.0001) were all greater when TM taken during dinner compared with breakfast.
","[{'ForeName': 'Sumanto', 'Initials': 'S', 'LastName': 'Haldar', 'Affiliation': 'Clinical Nutrition Research Centre, Singapore Institute for Clinical Sciences, Singapore.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Egli', 'Affiliation': 'Nestle Institute of Health Sciences, Lausanne, Switzerland.'}, {'ForeName': 'Carlos Antonio', 'Initials': 'CA', 'LastName': 'De Castro', 'Affiliation': 'Nestle Research Asia, Nestle Institute of Health Sciences, Singapore.'}, {'ForeName': 'Shia Lyn', 'Initials': 'SL', 'LastName': 'Tay', 'Affiliation': 'Clinical Nutrition Research Centre, Singapore Institute for Clinical Sciences, Singapore.'}, {'ForeName': 'Melvin Xu Nian', 'Initials': 'MXN', 'LastName': 'Koh', 'Affiliation': 'Clinical Nutrition Research Centre, Singapore Institute for Clinical Sciences, Singapore.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Darimont', 'Affiliation': 'Nestle Institute of Health Sciences, Lausanne, Switzerland.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Mace', 'Affiliation': 'Nestle Institute of Health Sciences, Lausanne, Switzerland.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Clinical Nutrition Research Centre, Singapore Institute for Clinical Sciences, Singapore jeya_henry@sics.a-star.edu.sg.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-001099']
114,32312242,Impact of medication review via tele-expertise on unplanned hospitalizations at 3 months of nursing homes patients (TEM-EHPAD): study protocol for a randomized controlled trial.,"BACKGROUND
Inappropriate drug prescribing causes preventable drug-related adverse events that result in increased morbidity and mortality, additional costs and diminished quality of life. Numerous initiatives have been launched to improve the quality of drug prescribing and safeguard the security of drug administration processes in nursing homes. Against the backdrop of implementation of telemedicine services, the focus of the present work is to evaluate the impact of a telemedication review carried out by a hospital physician and pharmacist as part of the telemedicine offer.
METHODS
The present study is a randomized controlled clinical trial. A total of 364 patients will be randomized into two groups: (1) an experimental group (182 patients) benefiting from a telemedication review using tele-expertise and (2) a control group (182 patients) receiving standard care. The primary endpoint will be rate of all-cause unplanned hospital admissions occurring within 3 months of randomization. The secondary endpoints will be rate of unplanned admissions at 6 months, patient quality of life, incidence of behavioral disturbances, number of falls, number of residents prescribed at least one inappropriate medication, nursing staff satisfaction, proposed medication reviews and their acceptability rate, characteristics of patients whose general practitioners have taken account of tele-expertise, efficacy of tele-expertise as compared to standard prescription and acceptability and satisfaction surveys of participating caregivers.
DISCUSSION
In the literature, various studies have investigated the utility of structured medication review processes, but outcome measures are heterogeneous, and results vary widely. Medication review can detect medication-related problems in many patients, but evidence of clinical impact is scant. Incremental cost-effectiveness ratios will be used to compare the cost and effectiveness of the experimental strategy and that of standard care. Our approach, involving the combination of an acceptability survey and a mixed-method (qualitative and quantitative) satisfaction survey, is particularly innovative. The results of this randomized trial are expected to confirm that medication review using tele-expertise has potential as a worthwhile care management strategy for nursing home residents.
TRIAL REGISTRATION
Clinicaltrials.gov NCT03640845; registered August 21, 2018 (Clinicaltrials.gov NCT03640845).",2020,Numerous initiatives have been launched to improve the quality of drug prescribing and safeguard the security of drug administration processes in nursing homes.,"['nursing home residents', 'nursing homes patients (TEM-EHPAD', '364 patients will be randomized into two groups: (1) an experimental group (182 patients']","['benefiting from a telemedication review using tele-expertise and (2) a control group (182 patients) receiving standard care', 'medication review via tele-expertise']","['Incremental cost-effectiveness ratios', 'rate of unplanned admissions at 6\u2009months, patient quality of life, incidence of behavioral disturbances, number of falls, number of residents prescribed at least one inappropriate medication, nursing staff satisfaction, proposed medication reviews and their acceptability rate, characteristics of patients whose general practitioners have taken account of tele-expertise, efficacy of tele-expertise as compared to standard prescription and acceptability and satisfaction surveys of participating caregivers', 'morbidity and mortality, additional costs and diminished quality of life', 'unplanned hospitalizations', 'rate of all-cause unplanned hospital admissions occurring within 3\u2009months of randomization']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040975', 'cui_str': 'Triethylenemelamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",364.0,0.143046,Numerous initiatives have been launched to improve the quality of drug prescribing and safeguard the security of drug administration processes in nursing homes.,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Correard', 'Affiliation': 'Service pharmacie, hôpital de la Timone, Assistance Publique des Hôpitaux de Marseille (AP-HM), Marseille, France. florian.correard@ap-hm.fr.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Montaleytang', 'Affiliation': 'Service pharmacie, hôpital de la Timone, Assistance Publique des Hôpitaux de Marseille (AP-HM), Marseille, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Costa', 'Affiliation': 'ORS PACA, Southeastern Health Regional Observatory, Marseille, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Astolfi', 'Affiliation': 'Service pharmacie, hôpital de la Timone, Assistance Publique des Hôpitaux de Marseille (AP-HM), Marseille, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Baumstarck', 'Affiliation': 'Aix-Marseille Univ, Marseille, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loubière', 'Affiliation': 'Aix-Marseille Univ, Marseille, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Amichi', 'Affiliation': ""Direction de la Recherche Clinique et de l'Innovation (DRCI), AP-HM, Marseille, France.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Auquier', 'Affiliation': 'Aix-Marseille Univ, Marseille, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Verger', 'Affiliation': 'Aix-Marseille Univ, Marseille, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Villani', 'Affiliation': 'Aix-Marseille Univ, Marseille, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Honore', 'Affiliation': 'Service pharmacie, hôpital de la Timone, Assistance Publique des Hôpitaux de Marseille (AP-HM), Marseille, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Daumas', 'Affiliation': 'Aix-Marseille Univ, Marseille, France.'}]",BMC geriatrics,['10.1186/s12877-020-01546-3']
115,31974691,Refining the criteria for immediate total-body CT after severe trauma.,"OBJECTIVES
Initial trauma care could potentially be improved when conventional imaging and selective CT scanning is omitted and replaced by immediate total-body CT (iTBCT) scanning. Because of the potentially increased radiation exposure by this diagnostic approach, proper selection of the severely injured patients is mandatory.
METHODS
In the REACT-2 trial, severe trauma patients were randomized to iTBCT or conventional imaging and selective CT based on predefined criteria regarding compromised vital parameters, clinical suspicion of severe injuries, or high-risk trauma mechanisms in five trauma centers. By logistic regression analysis with backward selection on the 15 study inclusion criteria, a revised set of criteria was derived and subsequently tested for prediction of severe injury and shifts in radiation exposure.
RESULTS
In total, 1083 patients were enrolled with median ISS of 20 (IQR 9-29) and median GCS of 13 (IQR 3-15). Backward logistic regression resulted in a revised set consisting of nine original and one adjusted criteria. Positive predictive value improved from 76% (95% CI 74-79%) to 82% (95% CI 80-85%). Sensitivity decreased by 9% (95% CI 7-11%). The area under the receiver operating characteristics curve remained equal and was 0.80 (95% CI 0.77-0.83), original set 0.80 (95% CI 0.77-0.83). The revised set retains 8.78 mSv (95% CI 6.01-11.56) for 36% of the non-severely injured patients.
CONCLUSIONS
Selection criteria for iTBCT can be reduced from 15 to 10 clinically criteria. This improves the positive predictive value for severe injury and reduces radiation exposure for less severely injured patients.
KEY POINTS
• Selection criteria for iTBCT can be reduced to 10 clinically useful criteria. • This reduces radiation exposure in 36% of less severely injured patients. • Overall discriminative capacity for selection of severely injured patients remained equal.",2020,Positive predictive value improved from 76% (95% CI 74-79%) to 82% (95% CI 80-85%).,"['1083 patients were enrolled with median ISS of 20 (IQR 9-29) and median GCS of 13 (IQR 3-15', 'severe trauma patients']","['iTBCT or conventional imaging and selective CT', 'conventional imaging and selective CT scanning']","['Positive predictive value', 'Sensitivity', 'radiation exposure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation (event)'}]",1083.0,0.196791,Positive predictive value improved from 76% (95% CI 74-79%) to 82% (95% CI 80-85%).,"[{'ForeName': 'Kaij', 'Initials': 'K', 'LastName': 'Treskes', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. k.treskes@amsterdamumc.nl.'}, {'ForeName': 'Teun P', 'Initials': 'TP', 'LastName': 'Saltzherr', 'Affiliation': 'Department of Surgery, Haaglanden Medical Center, Lijnbaan 32, 2512 VA, Den Haag, the Netherlands.'}, {'ForeName': 'Michael J R', 'Initials': 'MJR', 'LastName': 'Edwards', 'Affiliation': 'Trauma Unit, Department of Surgery, Radboud University Medical Center, Geert Grooteplein-Zuid 10, 6525 GA, Nijmegen, the Netherlands.'}, {'ForeName': 'Benn J A', 'Initials': 'BJA', 'LastName': 'Beuker', 'Affiliation': 'Trauma Unit, Department of Surgery, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, the Netherlands.'}, {'ForeName': 'Esther M M', 'Initials': 'EMM', 'LastName': 'Van Lieshout', 'Affiliation': ""Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, 's-Gravendijkwal 230, 3015 CE, Rotterdam, the Netherlands.""}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Hohmann', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University of Basel Hospital, Petersgraben, 4031, Basel, Switzerland.'}, {'ForeName': 'Jan S K', 'Initials': 'JSK', 'LastName': 'Luitse', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Ludo F M', 'Initials': 'LFM', 'LastName': 'Beenen', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anaesthesiology, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Clinical Research Unit/Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, location AMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'J Carel', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam University Medical Centers, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European radiology,['10.1007/s00330-019-06503-2']
116,31537010,"The developing gut-lung axis: postnatal growth restriction, intestinal dysbiosis, and pulmonary hypertension in a rodent model.","BACKGROUND
Postnatal growth restriction (PNGR) in premature infants increases risk of pulmonary hypertension (PH). In a rodent model, PNGR causes PH, while combining PNGR and hyperoxia increases PH severity. We hypothesized that PNGR causes intestinal dysbiosis and that treatment with a probiotic attenuates PNGR-associated PH.
METHOD
Pups were randomized at birth to room air or 75% oxygen (hyperoxia), to normal milk intake (10 pups/dam) or PNGR (17 pups/dam), and to probiotic Lactobacillus reuteri DSM 17938 or phosphate-buffered saline. After 14 days, PH was assessed by echocardiography and right ventricular hypertrophy (RVH) was assessed by Fulton's index (right ventricular weight/left ventricle + septal weight). The small bowel and cecum were analyzed by high-throughput 16S ribosomal RNA gene sequencing.
RESULTS
PNGR with or without hyperoxia (but not hyperoxia alone) altered the microbiota of the distal small bowel and cecum. Treatment with DSM 17938 attenuated PH and RVH in pups with PNGR, but not hyperoxia alone. DSM 17938 treatment decreased α-diversity. The intestinal microbiota differed based on oxygen exposure, litter size, and probiotic treatment.
CONCLUSION
PNGR causes intestinal dysbiosis and PH. Treatment with DSM 17938 prevents PNGR-associated RVH and PH. Changes in the developing intestine and intestinal microbiota impact the developing lung vasculature and RV.",2020,DSM 17938 treatment decreased α-diversity.,"['Pups were randomized at birth to', 'premature infants increases risk of pulmonary hypertension (PH']","['room air or 75% oxygen (hyperoxia), to normal milk intake (10 pups/dam) or PNGR', 'probiotic Lactobacillus reuteri DSM 17938 or phosphate-buffered saline', 'DSM', 'Postnatal growth restriction (PNGR']","['PNGR-associated RVH and PH', 'PH severity', 'echocardiography and right ventricular hypertrophy (RVH', 'small bowel and cecum', 'α-diversity', 'microbiota of the distal small bowel and cecum']","[{'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0556180', 'cui_str': 'Milk intake (observable entity)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0243109', 'cui_str': 'postnatal growth'}]","[{'cui': 'C0162770', 'cui_str': 'Right Ventricular Hypertrophy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0007531', 'cui_str': 'Cecum'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}]",,0.025137,DSM 17938 treatment decreased α-diversity.,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Wedgwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Cris', 'Initials': 'C', 'LastName': 'Warford', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Sharleen R', 'Initials': 'SR', 'LastName': 'Agvatisiri', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Phung N', 'Initials': 'PN', 'LastName': 'Thai', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Nipavan', 'Initials': 'N', 'LastName': 'Chiamvimonvat', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Kalanetra', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Robin H', 'Initials': 'RH', 'LastName': 'Steinhorn', 'Affiliation': ""Department of Hospitalist Medicine, Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Mills', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA. munderwood@ucdavis.edu.'}]",Pediatric research,['10.1038/s41390-019-0578-2']
117,32399632,Ecological momentary assessment of temptations and lapses in non-daily smokers.,"RATIONALE
Little is known about relapse among non-daily, intermittent smokers (ITS), who have difficulty quitting, despite a lack of dependence.
OBJECTIVES
To analyze situations associated with temptations to smoke and smoking lapses among ITS trying to maintain abstinence.
METHODS
Participants were 130 initially abstinent ITS in the placebo arm of a smoking cessation study. EMA data captured participants' situations and states in temptations (n = 976), including those that eventuated in lapses (n = 147), for up to 6 weeks. Randomly timed assessments assessed background states (n = 11,446). Participants also reported coping performed to prevent lapses. Multilevel analyses compared temptations to background situations, and lapse episodes to resolved temptations.
RESULTS
Temptations were marked by exposure to smoking cues, including others smoking, lax smoking restrictions, and alcohol consumption, as well as more negative affect. Lapses did not differ from resolved temptations in craving intensity, but were more often associated with smoking cues and availability of cigarettes, alcohol consumption, and worse affect, and were more often attributed to good moods. Both behavioral and cognitive coping responses were associated with avoiding lapsing, but behavioral coping had much larger effects. The effects of affective distress on lapse risk were mediated by its effects on coping.
CONCLUSIONS
Smoking cues play a major role in ITS' temptations and lapses, perhaps indicating a degree of behavioral dependence. Affective distress also played a role in ITS lapses, undermining the idea that the affective distress seen in daily smokers' lapses is due to nicotine withdrawal. The data reinforce the important role of coping in preventing lapses.",2020,"Lapses did not differ from resolved temptations in craving intensity, but were more often associated with smoking cues and availability of cigarettes, alcohol consumption, and worse affect, and were more often attributed to good moods.","['non-daily smokers', 'Participants were 130 initially abstinent ITS in the placebo arm of a smoking cessation study']",[],"['Affective distress', 'exposure to smoking cues, including others smoking, lax smoking restrictions, and alcohol consumption', 'smoking cues and availability of cigarettes, alcohol consumption']","[{'cui': 'C1880200', 'cui_str': 'Occasional tobacco smoker'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",130.0,0.0228674,"Lapses did not differ from resolved temptations in craving intensity, but were more often associated with smoking cues and availability of cigarettes, alcohol consumption, and worse affect, and were more often attributed to good moods.","[{'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Shiffman', 'Affiliation': 'Department of Psychology, University of Pittsburgh, 130 N. Bellefield Ave, Suite 510, Pittsburgh, PA, 15213, USA. shiffman@pitt.edu.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Scholl', 'Affiliation': 'Department of Psychology, University of Pittsburgh, 130 N. Bellefield Ave, Suite 510, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Ferguson', 'Affiliation': 'College of Health & Medicine, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Public Health Sciences, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05539-3']
118,32334527,Cardiopulmonary exercise capacity and quality of life of patients with heart failure undergoing a functional training program: study protocol for a randomized clinical trial.,"BACKGROUND
Exercise intolerance is a common finding in heart failure that generates a vicious cycle in which the individual starts to limit his activities even more due to progressive fatigue. Regular physical exercise can increase the cardiopulmonary exercise capacity of these individuals. A new approach to physical exercise, known as functional training, could improve the oxygen consumption and quality of life of patients with heart failure; however, there is no information about the effect of this modality of exercise in this patient population. This randomized trial will compare the effects of 36 sessions of functional training versus strength training in heart failure patients.
METHODS
This randomized parallel-design examiner-blinded clinical trial includes individuals of both sexes aged ≥40 years receiving regular follow-up at a single academic hospital. Subjects will be randomly allocated to an intervention group (for 12-week functional training) or an active comparator group (for 12-week strength training). The primary outcomes will be the difference from baseline to the 3-month time point in peak oxygen consumption on cardiopulmonary exercise testing and quality of life assessed by the Minnesota Living with Heart Failure Questionnaire. Secondary outcome measures will include functionality assessed by the Duke Activity Status Index and gait speed test; peripheral and inspiratory muscular strength, assessed by hand grip and manovacuometry testing, respectively; endothelial function by brachial artery flow-mediated dilation; lean body mass by arm muscle circumference; and participant adherence to the exercise programs classified as a percentage of the prescribed exercise dose.
DISCUSSION
The functional training program aims to improve the functional capacity of the individual using exercises that relate to his specific physical activity transferring gains effectively to one's daily life. In this context, we believe that that functional training can increase the cardiopulmonary exercise capacity and quality of life of patients with heart failure. The trial has been recruiting patients since October 2017.
TRIAL REGISTRATION
NCT03321682. Registered on October 26, 2017.",2020,"A new approach to physical exercise, known as functional training, could improve the oxygen consumption and quality of life of patients with heart failure; however, there is no information about the effect of this modality of exercise in this patient population.","['individuals of both sexes aged ≥40\u2009years receiving regular follow-up at a single academic hospital', 'patients with heart failure', 'patients with heart failure undergoing a functional training program', 'heart failure patients']","['Regular physical exercise', 'functional training', 'functional training versus strength training', 'intervention group (for 12-week functional training) or an active comparator group (for 12-week strength training']","['cardiopulmonary exercise capacity', 'Cardiopulmonary exercise capacity and quality of life', '3-month time point in peak oxygen consumption on cardiopulmonary exercise testing and quality of life\xa0assessed by the Minnesota Living with Heart Failure Questionnaire', 'cardiopulmonary exercise capacity and quality of life', 'oxygen consumption and quality of life', 'functionality assessed by the Duke Activity Status Index and gait speed test; peripheral and inspiratory muscular strength, assessed by hand grip and manovacuometry testing, respectively; endothelial function by brachial artery flow-mediated dilation; lean body mass by arm muscle circumference; and participant adherence to the exercise programs classified as a percentage of the prescribed exercise dose']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0556969', 'cui_str': 'times/month'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4720913', 'cui_str': 'Duke activity status index'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.0495326,"A new approach to physical exercise, known as functional training, could improve the oxygen consumption and quality of life of patients with heart failure; however, there is no information about the effect of this modality of exercise in this patient population.","[{'ForeName': 'Daniela Meirelles', 'Initials': 'DM', 'LastName': 'do Nascimento', 'Affiliation': 'Exercise Pathophysiology Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil. dmnascimento@hcpa.edu.br.'}, {'ForeName': 'Karina Costa', 'Initials': 'KC', 'LastName': 'Machado', 'Affiliation': 'Exercise Pathophysiology Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Patrícia Martins', 'Initials': 'PM', 'LastName': 'Bock', 'Affiliation': 'Exercise Pathophysiology Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Marco Aurélio Lumertz', 'Initials': 'MAL', 'LastName': 'Saffi', 'Affiliation': 'Exercise Pathophysiology Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Livia Adams', 'Initials': 'LA', 'LastName': 'Goldraich', 'Affiliation': 'London Health Sciences Center and Western University, London, Canada.'}, {'ForeName': 'Anderson Donelli', 'Initials': 'AD', 'LastName': 'Silveira', 'Affiliation': 'Exercise Pathophysiology Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Clausell', 'Affiliation': 'Medical School, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Beatriz D', 'Initials': 'BD', 'LastName': 'Schaan', 'Affiliation': 'Exercise Pathophysiology Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01481-6']
119,32305727,A polymorphism within the R-spondin 2 gene predicts outcome in metastatic colorectal cancer patients treated with FOLFIRI/bevacizumab: data from FIRE-3 and TRIBE trials.,"BACKGROUND
Through enhancement of the Wnt signalling pathway, R-spondins are oncogenic drivers in colorectal cancer. Experimental data suggest that the R-spondin/Wnt axis stimulates vascular endothelial growth factor (VEGF)-dependent angiogenesis. We therefore hypothesise that variations within R-spondin genes predict outcome in patients with metastatic colorectal cancer (mCRC) treated with upfront FOLFIRI and bevacizumab.
PATIENTS AND METHODS
773 patients with mCRC enrolled in the randomised phase III FIRE-3 and TRIBE trials and receiving either FOLFIRI/bevacizumab (training and validation cohorts) or FOLFIRI/cetuximab (control group) were involved in this study. The impact of six functional single-nucleotide polymorphisms (SNPs) within the R-spondin 1-3 genes on outcome was evaluated.
RESULTS
RAS and KRAS wild-type patients harbouring any G allele of the RSPO2 rs555008 SNP had a longer overall survival compared with those having a TT genotype in both the training (FIRE-3) and validation (TRIBE) cohorts (29.0 vs 23.6 months, P = 0.009 and 37.8 vs 19.4 months, P = 0.021 for RAS wild-type patients and 28.4 vs 22.3 months, P = 0.011 and 36.0 vs 23.3 months, P = 0.046 for KRAS wild-type patients). Conversely, any G allele carriers with KRAS and RAS mutant tumours exhibited a shorter progression-free survival compared with TT genotype carriers, whereas the results were clinically more evident for KRAS mutant patients in both the training and validation cohorts (8.1 vs 11.2 months, P = 0.023 and 8.7 vs 10.3 months, P = 0.009).
CONCLUSION
Genotyping of the RSPO2 rs555008 polymorphism may help to select patients who will derive the most benefit from FOLFIRI/bevacizumab dependent on (K)RAS mutational status.",2020,"Conversely, any G allele carriers with KRAS and RAS mutant tumours exhibited a shorter progression-free survival compared with TT genotype carriers, whereas the results were clinically more evident for KRAS mutant patients in both the training and validation cohorts (8.1 vs 11.2 months, P = 0.023 and 8.7 vs 10.3 months, P = 0.009).
","['patients with metastatic colorectal cancer (mCRC) treated with', '773 patients with mCRC enrolled in the randomised phase III FIRE-3 and TRIBE trials and receiving either', 'metastatic colorectal cancer patients treated with']","['FOLFIRI/bevacizumab', 'bevacizumab', 'upfront FOLFIRI and bevacizumab', 'six functional single-nucleotide polymorphisms (SNPs', 'FOLFIRI/bevacizumab (training and validation cohorts) or FOLFIRI/cetuximab (control group']","['overall survival', 'shorter progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0040881', 'cui_str': 'Tribes'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",773.0,0.0944452,"Conversely, any G allele carriers with KRAS and RAS mutant tumours exhibited a shorter progression-free survival compared with TT genotype carriers, whereas the results were clinically more evident for KRAS mutant patients in both the training and validation cohorts (8.1 vs 11.2 months, P = 0.023 and 8.7 vs 10.3 months, P = 0.009).
","[{'ForeName': 'Martin D', 'Initials': 'MD', 'LastName': 'Berger', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Department of Medical Oncology, Inselspital, Bern University Hospital, University of Bern, Switzerland. Electronic address: martin.berger@insel.ch.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Medical Department, Division of Hematology, Oncology, and Tumor Immunology (Campus Charité Mitte), Charité Universitaetsmedizin Berlin, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Center, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Dongyun', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Miyamoto', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Mitsukuni', 'Initials': 'M', 'LastName': 'Suenaga', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Schirripa', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padova, Italy.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Hanna', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Soni', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Puccini', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Ryuma', 'Initials': 'R', 'LastName': 'Tokunaga', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Madiha', 'Initials': 'M', 'LastName': 'Naseem', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Battaglin', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padova, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'U.O. Oncologia Medica, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padova, Italy.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.02.048']
120,31739249,Attentional bias modification with a new paradigm: The effect of the Detection Engagement and Savoring Positivity (DESP) task on eye-tracking of attention.,"BACKGROUND AND OBJECTIVES
We tested the effect of a new Attentional Bias Modification (ABM) task - the Detection Engagement and Savoring Positivity (DESP) task - on attentional biases. The DESP is innovative in that it involves a procedure of savoring the positivity of various pictures.
METHODS
Participants were randomly assigned to the DESP or to a placebo control condition (experiment 1; n = 38) or a condition controlling for savoring (experiment 2; n = 54) in a pre-post/training experimental design. During one week, the participants completed the DESP or the control task once a day between three and six times. We assessed the effects of the DESP task on various attentional biases (i.e. positive, negative and threat) by computing dwell time from an eye-tracking technology before and after the training, and also one week after the post-training session in experiment 2.
RESULTS
In both experiments, the attentional bias toward positive stimuli between the pre- and the post-training increased significantly more in the DESP task condition than in the control conditions. Negative and threat attentional biases were not significantly affected by the experimental manipulations. Experiment 2 revealed that the DESP task - including the savoring instruction - increased significantly more the positive attentional bias than a task excluding this step and that this effect remained significant one week after the post-training session.
LIMITATIONS
Our samples were mainly composed of women participants. This prevents generalization of the findings.
CONCLUSIONS
The DESP task offers promising perspectives for sustainably improving attention to positive information.",2020,Negative and threat attentional biases were not significantly affected by the experimental manipulations.,['Participants'],"['Detection Engagement and Savoring Positivity (DESP) task', 'DESP task', 'new Attentional Bias Modification (ABM) task - the Detection Engagement and Savoring Positivity (DESP) task ', 'DESP', 'placebo control condition (experiment 1; n\u202f=\u202f38) or a condition controlling for savoring (experiment 2; n\u202f=\u202f54) in a pre-post/training experimental design']","['attentional bias toward positive stimuli', 'DESP task condition', 'Negative and threat attentional biases', 'DESP task - including the savoring instruction ', 'various attentional biases', 'positive attentional bias']",[],"[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0015320', 'cui_str': 'Experimental Design'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]",,0.030815,Negative and threat attentional biases were not significantly affected by the experimental manipulations.,"[{'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Corman', 'Affiliation': 'Université Clermont-Auvergne (UCA), UMR CNRS 6024, LAPSCO, Clermont-Ferrand, France.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Aubret', 'Affiliation': 'Université Clermont-Auvergne (UCA), UMR CNRS 6024, LAPSCO, Clermont-Ferrand, France.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ghazal', 'Affiliation': 'Université Clermont-Auvergne (UCA), UMR CNRS 6024, LAPSCO, Clermont-Ferrand, France.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Berthon', 'Affiliation': 'Université Clermont-Auvergne (UCA), UMR CNRS 6024, LAPSCO, Clermont-Ferrand, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Chausse', 'Affiliation': 'Université Clermont-Auvergne (UCA), UMR CNRS 6024, LAPSCO, Clermont-Ferrand, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lohou', 'Affiliation': 'Université Clermont Auvergne (UCA), CNRS, SIGMA Clermont, Institut Pascal, Clermont-Ferrand, France.'}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Dambrun', 'Affiliation': 'Université Clermont-Auvergne (UCA), UMR CNRS 6024, LAPSCO, Clermont-Ferrand, France. Electronic address: michael.dambrun@uca.fr.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101525']
121,31485039,Posterior capsule opacification and Nd:YAG laser rates with two hydrophobic acrylic single-piece IOLs.,"OBJECTIVES
To evaluate the development of posterior capsule opacification (PCO) and Nd:YAG capsulotomy rates following implantation of two hydrophobic acrylic IOLs.
METHODS
In a randomized, controlled trial, 80 patients with bilateral senile cataract were implanted with the hydrophobic acrylic single-piece intraocular Lenses (IOLs) EyeCee One in one eye and iMics1 in the other. Outcomes of 39 patients (78 eyes) were evaluated after 3 years. Automated Quantification of After-Cataract (AQUA; for PCO occurrence), visual acuity, anterior fibrosis, capsule-optic edge interaction and distance between anterior and posterior capsule IOL surface were analysed.
RESULTS
After a mean follow-up of 38 ± 1.95 months, Nd:YAG capsulotomy occurred at a rate of 15.4% and 46.2% in the EyeCee One and iMics1 groups, respectively (p < 0.01). Respective mean PCO scores measured by AQUA were 1.57 ± 1.63 and 2.45 ± 1.44 (p = 0.019). A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes. A gap between the posterior capsule and the posterior surface of the lens was observed in 76% of EyeCee One eyes and 35% of iMics1 eyes.
CONCLUSIONS
Study findings suggest that PCO and Nd:YAG capsulotomy rates are significantly lower in eyes implanted with the EyeCee One IOL compared to the iMics1 IOL. Optic sharpness and lens material seem to be the decisive factors, while the stepped edge beneath the haptic junction appeared to be ineffective.",2020,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"['80 patients with bilateral senile cataract', '39 patients (78 eyes) were evaluated after 3 years']","['hydrophobic acrylic single-piece intraocular Lenses (IOLs', 'hydrophobic acrylic single-piece IOLs', 'posterior capsule opacification (PCO) and Nd']","['PCO and Nd:YAG capsulotomy rates', 'Respective mean PCO scores', 'visual acuity, anterior fibrosis, capsule-optic edge interaction and distance between anterior and posterior capsule IOL surface', 'IOL optic', 'YAG capsulotomy rates', 'YAG capsulotomy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2025430', 'cui_str': 'Senile cataract of both eyes'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0440181', 'cui_str': 'Acrylic dental material (substance)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]",80.0,0.0689483,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schriefl', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kundi', 'Affiliation': 'Center for Public Health, Medical University of Vienna, Kinderspitalgasse 15, 1090, Vienna, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Pieh', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria. rupert.menapace@meduniwien.ac.at.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kriechbaum', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}]","Eye (London, England)",['10.1038/s41433-019-0569-x']
122,32034481,Rationale and design of two randomized sham-controlled trials of catheter-based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design.,"BACKGROUND
The SPYRAL HTN clinical trial program was initiated with two 80-patient pilot studies, SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED, which provided biological proof of principle that renal denervation has a blood pressure-lowering effect versus sham controls for subjects with uncontrolled hypertension in the absence or presence of antihypertensive medications, respectively.
TRIAL DESIGN
Two multicenter, prospective, randomized, sham-controlled trials have been designed to evaluate the safety and efficacy of catheter-based renal denervation for the reduction of blood pressure in subjects with hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) or presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications. The primary efficacy endpoint is baseline-adjusted change from baseline in 24-h ambulatory systolic blood pressure. The primary safety endpoint is incidence of major adverse events at 1 month after randomization (or 6 months in cases of new renal artery stenosis). Both trials utilize a Bayesian design to allow for prespecified interim analyses to take place, and thus, the final sample sizes are dependent on whether enrollment is stopped at the first or second interim analysis. SPYRAL HTN-OFF MED Pivotal will enroll up to 300 subjects and SPYRAL HTN-ON MED Expansion will enroll up to 221 subjects. A novel Bayesian power prior approach will leverage historical information from the pilot studies, with a degree of discounting determined by the level of agreement with data from the prospectively powered studies.
CONCLUSIONS
The Bayesian paradigm represents a novel and promising approach in device-based hypertension trials.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02439749 (SPYRAL HTN-OFF MED Pivotal) and NCT02439775 (SPYRAL HTN-ON MED Expansion).",2020,The primary safety endpoint is incidence of major adverse events at 1 month after randomization (or 6 months in cases of new renal artery stenosis).,"['subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications', 'subjects with hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) or presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications']",['catheter-based renal denervation'],"['safety and efficacy', 'incidence of major adverse events', 'baseline-adjusted change from baseline in 24-h ambulatory systolic blood pressure', 'blood pressure']","[{'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",300.0,0.0699425,The primary safety endpoint is incidence of major adverse events at 1 month after randomization (or 6 months in cases of new renal artery stenosis).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Universitätsklinikum des Saarlandes, Saarland University, Homburg, Germany. Michael.Boehm@uks.eu.'}, {'ForeName': 'Raymond R', 'Initials': 'RR', 'LastName': 'Townsend', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, GA, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mahfoud', 'Affiliation': 'Universitätsklinikum des Saarlandes, Saarland University, Homburg, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Weber', 'Affiliation': 'State University of New York, Downstate Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Roland E', 'Initials': 'RE', 'LastName': 'Schmieder', 'Affiliation': 'University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tsioufis', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Graeme L', 'Initials': 'GL', 'LastName': 'Hickey', 'Affiliation': 'Medtronic PLC, Santa Rosa, CA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fahy', 'Affiliation': 'Medtronic PLC, Santa Rosa, CA, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'DeBruin', 'Affiliation': 'Medtronic PLC, Santa Rosa, CA, USA.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Brar', 'Affiliation': 'Medtronic PLC, Santa Rosa, CA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01595-z']
123,32325176,Effect of preparation design on the fracture behavior of ceramic occlusal veneers in maxillary premolars.,"OBJECTIVES
The fracture strengths of four types of occlusal veneers and a traditional full crown ceramic restoration and the influence of preparation design on the stress of restorations were examined.
METHODS
Forty intact maxillary premolars randomly divided into five groups were prepared based on the demands of type O (occlusal surface coverage), OF (occlusal and lingual surface coverage), POF (occlusal, lingual, and mesial surface coverage), and POFP (occlusal, lingual, mesial, and distal surface coverage) veneers and full crown, and then restored by glass ceramic. Specimens were subjected to fracture resistance tests after cyclic loading. The fracture strengths and modes were analyzed statistically. The level of significance was set at α = 0.05. One maxillary premolar was prepared for type O, OF, POF, POFP veneer and full crown, and then scanned to establish finite element models. The mean fracture load was applied vertically to calculate the maximum principal stress on the ceramic.
RESULTS
Type O veneer showed higher fracture strength than type POF and POFP veneers (P < 0.05). Both type O and OF veneers exhibited higher fracture strength than full crown (P < 0.05). No significant difference in failure mode was observed. The maximum principal stress for type O, OF, POF, POFP veneers, and full crown increased progressively and concentrated at the bonding surface directly beneath the loading area.
CONCLUSIONS
Four types of occlusal veneer showed fracture strengths that considerably exceeded normal biting forces. They represent conservative alternatives to full crowns and present a viable treatment for severely worn teeth.
CLINICAL SIGNIFICANCE
The occlusal veneers with different preparation designs, including type O, OF, POF and POFP veneers, show higher fracture resistances than traditional full coverage crowns that considerably exceed the normal biting forces. Therefore, these represent conservative alternatives to crown restorations and present a viable treatment for restoring severely worn teeth.",2020,Both type O and OF veneers exhibited higher fracture strength than full crown (P < 0.05).,"['Forty intact maxillary premolars', 'maxillary premolars']",[],"['fracture behavior of ceramic occlusal veneers', 'failure mode', 'maximum principal stress for type O, OF, POF, POFP veneers, and full crown', 'fracture strengths', 'fracture strength']","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]",[],"[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0559953', 'cui_str': 'Veneer'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025322', 'cui_str': 'Premature menopause'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}]",40.0,0.0209738,Both type O and OF veneers exhibited higher fracture strength than full crown (P < 0.05).,"[{'ForeName': 'Xiaoqiong', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: huangxq36@mail2.sysu.edu.cn.""}, {'ForeName': 'Leiyan', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: zouly5@mail2.sysu.edu.cn.""}, {'ForeName': 'Run', 'Initials': 'R', 'LastName': 'Yao', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Shuyi', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: shuyiwu@21cn.com.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: liy8@mail.sysu.edu.cn.""}]",Journal of dentistry,['10.1016/j.jdent.2020.103346']
124,32306953,Comparison of two caries prevention programs among Thai kindergarten: a randomized controlled trial.,"BACKGROUND
Intensified preventive regimen based on a 'high-risk' approach has been proposed instead the routine prevention that is generally given to the whole population. The effectiveness of these regimens may still be an issue. Therefore, the aim of this study was to compare two preventive programs carried out in a Public School for kindergarten children.
METHODS
The data from clinical examinations were used to assess the caries risk for 121 children. Children with at least 2 carious lesions were considered as high risk for dental caries development. These children were randomized into two groups. Half (High risk basic-HRB group) were provided the basic prevention regimen (oral-hygiene instruction and hands-on brushing practice for teachers and caregivers, daytime tooth brushing supervised by teachers at least once a week, newly erupted first permanent molar sealant, provision of toothbrush, fluoride-containing dentifrice, and a guidebook), which was also given to low-risk children (Low risk basic-LRB group). The other half (High risk intensive-HRI group) were additionally given an intensified preventive regimen (F-varnish application, primary molar sealant, and silver diamine fluoride (SDF) application on carious lesions). Clinical examinations were performed semiannually to determine the dmfs caries increment of the three groups.
RESULTS
The 89 children completed the 24-month examination were 3- to 5-year-old with 19, 35, and 35 children in the LRB, HRB, and HRI group, respectively. The new caries development at 24 months of the HRB group (75%) was higher than that of the HRI group (65.7%) and the LRB group (21.1%). One-way analysis of variance (ANOVA) indicated no significant differences of caries increment between the HRB and HRI groups at the end of our study (p = 0.709).
CONCLUSIONS
The negligible difference in caries increment between the HRI and HRB groups implies that intensified prevention produced minimal additional benefit. Offering all children only basic prevention could have obtained virtually the same preventive effect with substantially less effort and lower cost.
TRIAL REGISTRATION
Thai Clinical Trials Registry (TCTR), TCTR20180124001. Registered 24 January 2018 - Retrospectively registered.",2020,"One-way analysis of variance (ANOVA) indicated no significant differences of caries increment between the HRB and HRI groups at the end of our study (p = 0.709).
","['Registered 24 January 2018 - Retrospectively registered', 'Thai kindergarten', '121 children', 'Public School for kindergarten children', '89 children completed the 24-month examination were 3- to 5-year-old with 19, 35, and 35 children in the LRB, HRB, and HRI group, respectively', 'Children with at least 2 carious lesions']","['intensified preventive regimen (F-varnish application, primary molar sealant, and silver diamine fluoride (SDF) application', 'basic prevention regimen (oral-hygiene instruction and hands-on brushing practice for teachers and caregivers, daytime tooth brushing supervised by teachers at least once a week, newly erupted first permanent molar sealant, provision of toothbrush, fluoride-containing dentifrice, and a guidebook']",['caries increment'],"[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0376666', 'cui_str': 'Guidebooks'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}]",,0.0353096,"One-way analysis of variance (ANOVA) indicated no significant differences of caries increment between the HRB and HRI groups at the end of our study (p = 0.709).
","[{'ForeName': 'Pagaporn', 'Initials': 'P', 'LastName': 'Pisarnturakit', 'Affiliation': 'Department of Community Dentistry, Faculty of Dentistry, Chulalongkorn University, 34 Henry Dunant Road, Patumwan, Bangkok, 10330, Thailand.'}, {'ForeName': 'Palinee', 'Initials': 'P', 'LastName': 'Detsomboonrat', 'Affiliation': 'Department of Community Dentistry, Faculty of Dentistry, Chulalongkorn University, 34 Henry Dunant Road, Patumwan, Bangkok, 10330, Thailand. Palinee.d@chula.ac.th.'}]",BMC oral health,['10.1186/s12903-020-01107-5']
125,31427745,"Efficacy of TIMOLOL nasal spray as a treatment for epistaxis in hereditary hemorrhagic telangiectasia. A double-blind, randomized, placebo-controlled trial.","Hereditary hemorrhagic telangiectasia is a rare vascular genetic disease. Epistaxis is the most frequent and disabling manifestation, and timolol appears to be a new therapeutic option as non-selective beta-blockers have in vitro and in vivo anti-angiogenic properties. Our main objective was to evaluate the efficacy of TIMOLOL nasal spray as a treatment for epistaxis in hereditary hemorrhagic telangiectasia. This study is a single-center, randomized, phase 2, double-blind placebo-controlled study with an allocation ratio of 1:1. It was proposed to patients with hereditary hemorrhagic telangiectasia monitored at the French Reference Center, and we included patients aged over 18 years, diagnosed with hereditary hemorrhagic telangiectasia and epistaxis. The treatment was self-administered by the patient with a posology of one spray (50 µL) of timolol 0.5% or placebo in each nostril twice a day for 28 consecutive days. The primary efficacy endpoint was mean monthly epistaxis duration, assessed by monitoring epistaxis grids. A total of 58 patients were randomized and treated. The baseline characteristics were similar in the 2 groups. Mean monthly epistaxis duration measured at 3 months was not significantly different in the 26 patients receiving the drug in comparison with the placebo group (p = 0.54). Toxicity was low and no severe adverse events were reported. One limitation is that we included all HHT patients with nosebleeds and did not take into account history of nasal surgery or nasal crusts. Timolol, administered by nasal spray at a dose of 0.25 mg in each nostril twice a day for 28 consecutive days, did not improve epistaxis in patients with hereditary hemorrhagic telangiectasia at 4 months after the beginning of the treatment.",2019,Mean monthly epistaxis duration measured at 3 months was not significantly different in the 26 patients receiving the drug in comparison with the placebo group (p = 0.54).,"['HHT patients with nosebleeds and did not take into account history of nasal surgery or nasal crusts', 'epistaxis in hereditary hemorrhagic telangiectasia', 'patients with hereditary hemorrhagic telangiectasia monitored at the French Reference Center, and we included patients aged over 18 years, diagnosed with hereditary hemorrhagic telangiectasia and epistaxis', '58 patients']","['Timolol', 'placebo', 'timolol 0.5% or placebo', 'TIMOLOL nasal spray']","['mean monthly epistaxis duration, assessed by monitoring epistaxis grids', 'severe adverse events', 'Mean monthly epistaxis duration', 'Toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0188970', 'cui_str': 'Rhinosurgery'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0392749', 'cui_str': 'Crusted (qualifier value)'}, {'cui': 'C0039445', 'cui_str': 'Osler-Rendu-Weber Disease'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",58.0,0.265997,Mean monthly epistaxis duration measured at 3 months was not significantly different in the 26 patients receiving the drug in comparison with the placebo group (p = 0.54).,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Dupuis-Girod', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Femme-Mère-Enfants, Service de Génétique et centre de référence pour la maladie de Rendu-Osler, Bron, F-69677, France. sophie.dupuis-girod@chu-lyon.fr.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Pitiot', 'Affiliation': ""Hospices Civils de Lyon, Hôpital E. Herriot, Service d'ORL, Lyon, F-69437, France.""}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Bergerot', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Louis Pradel, Service de cardiologie, Lyon, F-69677, France.'}, {'ForeName': 'Anne-Emmanuelle', 'Initials': 'AE', 'LastName': 'Fargeton', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Femme-Mère-Enfants, Service de Génétique et centre de référence pour la maladie de Rendu-Osler, Bron, F-69677, France.'}, {'ForeName': 'Marjolaine', 'Initials': 'M', 'LastName': 'Beaudoin', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Femme-Mère-Enfants, Service de Génétique et centre de référence pour la maladie de Rendu-Osler, Bron, F-69677, France.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Decullier', 'Affiliation': 'Hospices Civils de Lyon, pôle Santé Publique, Lyon, F-69003, France.'}, {'ForeName': 'Valentine', 'Initials': 'V', 'LastName': 'Bréant', 'Affiliation': 'Hospices Civils de Lyon, Pharmacie, Hôpital Louis Pradel, Bron, F-69677, France.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Colombet', 'Affiliation': 'Hospices Civils de Lyon, Pharmacie, Hôpital Louis Pradel, Bron, F-69677, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Philouze', 'Affiliation': ""Hospices Civils de Lyon, Hôpital de la Croix Rousse, Service d'ORL, Lyon, F-69317, France.""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Faure', 'Affiliation': ""Hospices Civils de Lyon, Hôpital E. Herriot, Service d'ORL, Lyon, F-69437, France.""}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Letievant', 'Affiliation': ""Hospices Civils de Lyon, Hôpital E. Herriot, Service d'ORL, Lyon, F-69437, France.""}]",Scientific reports,['10.1038/s41598-019-48502-9']
126,31666688,"Inhaled nitric oxide as an adjunct to neonatal resuscitation in premature infants: a pilot, double blind, randomized controlled trial.","BACKGROUND
Nitric oxide (NO) plays an important role in normal postnatal transition. Our aims were to determine whether adding inhaled NO (iNO) decreases supplemental oxygen exposure in preterm infants requiring positive pressure ventilation (PPV) during resuscitation and to study iNO effects on heart rate (HR), oxygen saturation (SpO 2 ), and need for intubation during the first 20 min of life.
METHODS
This was a pilot, double-blind, randomized, placebo-controlled trial. Infants 25 0/7-31 6/7 weeks' gestational age requiring PPV with supplemental oxygen during resuscitation were enrolled. PPV was initiated with either oxygen (FiO 2 -0.30) + iNO at 20 ppm (iNO group) or oxygen (FiO 2 -0.30) + nitrogen (placebo group). Oxygen was titrated targeting defined SpO 2 per current guidelines. After 10 min, iNO/nitrogen was weaned stepwise per protocol and terminated at 17 min.
RESULTS
Twenty-eight infants were studied (14 per group). The mean gestational age in both groups was similar. Cumulative FiO 2 and rate of exposure to high FiO 2 (>0.60) were significantly lower in the iNO group. There were no differences in HR, SpO 2 , and need for intubation.
CONCLUSIONS
Administration of iNO as an adjunct during neonatal resuscitation is feasible without side effects. It diminishes exposure to high levels of supplemental oxygen.",2020,Cumulative FiO 2 and rate of exposure to high FiO 2 (>0.60) were significantly lower in the iNO group.,"['premature infants', 'preterm infants requiring positive pressure ventilation (PPV', ""Infants 25 0/7-31 6/7 weeks' gestational age requiring PPV with supplemental oxygen during resuscitation were enrolled""]","['placebo', 'inhaled NO (iNO', 'Inhaled nitric oxide', 'oxygen (FiO 2 -0.30)\u2009+\u2009iNO at 20\u2009ppm (iNO group) or oxygen (FiO 2 -0.30)\u2009+\u2009nitrogen (placebo']","['mean gestational age', 'heart rate (HR), oxygen saturation (SpO 2 ), and need for intubation', 'Cumulative FiO 2 and rate of exposure to high FiO 2', 'HR, SpO 2 , and need for intubation']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.552969,Cumulative FiO 2 and rate of exposure to high FiO 2 (>0.60) were significantly lower in the iNO group.,"[{'ForeName': 'Krishnamurthy', 'Initials': 'K', 'LastName': 'Sekar', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. Kris-Sekar@ouhsc.edu.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Szyld', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCoy', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wlodaver', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Dannaway', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Helmbrecht', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Julee', 'Initials': 'J', 'LastName': 'Riley', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Manfredo', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis Health, Sacramento, CA, USA.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Noori', 'Affiliation': ""Fetal and Neonatal Institute, Division of Neonatology, Children's Hospital of Los Angeles, Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.""}]",Pediatric research,['10.1038/s41390-019-0643-x']
127,32322048,Effects of rice-based and wheat-based diets on bowel movements in young Korean women with functional constipation.,"BACKGROUND
Although several studies have reported the effects that dietary fiber intake from different types of grains and fiber components have on bowel movements, insufficient attention has been paid to comparing and evaluating the effects of rice-based and wheat-based diets. This study compared and evaluated the effects of ingesting rice-based (brown rice-based diet: BRD; white rice-based diet: WRD) and wheat-based diet (WD) on the bowel movements of young women with functional constipation.
METHOD
Based on an open, randomized, controlled, and parallel design, 39 subjects were assigned to BRD, WRD, and WD groups (13 in each group). Each participant had received three types of experimental diets over the course of 4 weeks and we recommended that the subjects eat only the test diet provided during the study. Primary outcomes (total colon transit time TCTT) and secondary outcomes (bowel movements, short-chain fatty acid content, and fecal enzyme activity) were compared before and after the 4-week intervention period.
RESULTS
After the 4-week study, the rice-based diet (BRD and WRD) groups and the WD group had a statistically significant difference in TCTT (p = 0.028). The TCTT of the BRD group was significantly reduced (p = 0.028) compared with the WRD group (-16.5 ± 8.1 vs +6.8 ± 2.1), and the TCTT of the WD group was also significantly reduced (p = 0.022) compared with that of the WRD group (-17.1 ± 11.9 vs +6.8 ± 2.1).
CONCLUSION
Among women with functional constipation, the BRD and WD both improved bowel function by reducing TCTT and increasing the number of bowel movements compared with the WRD group.",2020,"The TCTT of the BRD group was significantly reduced (p = 0.028) compared with the WRD group (-16.5 ± 8.1 vs +6.8 ± 2.1), and the TCTT of the WD group was also significantly reduced (p = 0.022) compared with that of the WRD group (-17.1 ± 11.9 vs +6.8 ± 2.1).
","['39 subjects were assigned to BRD, WRD, and WD groups (13 in each group', 'young women with functional constipation', 'young Korean women with functional constipation', 'women with functional constipation']","['rice-based and wheat-based diets', 'ingesting rice-based (brown rice-based diet: BRD; white rice-based diet: WRD) and wheat-based diet (WD']","['number of bowel movements', 'bowel movements', 'Primary outcomes (total colon transit time TCTT) and secondary outcomes (bowel movements, short-chain fatty acid content, and fecal enzyme activity']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0452710', 'cui_str': 'Brown rice'}, {'cui': 'C0452712', 'cui_str': 'White rice'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}]",39.0,0.0272554,"The TCTT of the BRD group was significantly reduced (p = 0.028) compared with the WRD group (-16.5 ± 8.1 vs +6.8 ± 2.1), and the TCTT of the WD group was also significantly reduced (p = 0.022) compared with that of the WRD group (-17.1 ± 11.9 vs +6.8 ± 2.1).
","[{'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Jung', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Jeonbuk, 54907, Republic of Korea.'}, {'ForeName': 'Mi-Ra', 'Initials': 'MR', 'LastName': 'Oh', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Jeonbuk, 54907, Republic of Korea.'}, {'ForeName': 'Soo-Hyun', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Jeonbuk, 54907, Republic of Korea.'}, {'ForeName': 'Soo-Wan', 'Initials': 'SW', 'LastName': 'Chae', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Jeonbuk, 54907, Republic of Korea. soowan@jbnu.ac.kr.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0636-1']
128,32303198,Study on advance care planning in care dependent community-dwelling older persons in Germany (STADPLAN): protocol of a cluster-randomised controlled trial.,"BACKGROUND
In Germany, advance care planning (ACP) was first introduced by law in 2015. However, ACP is still uncommon in Germany and only few people have advance directive forms. This study aims to evaluate an ACP program in care dependent community-dwelling persons, compared to optimised usual care.
METHODS
A cluster-randomised controlled trial of 12 months duration will be conducted in 3 German study sites comparing the pretested ACP-counselling offered by trained nurses with a control group receiving optimised usual care. Using external concealed randomisation, 16 home care services each will be included in the intervention and the control group (30 participants per cluster; n = 960). Eligibility criteria for patients are: ≥60 years, somehow care dependent, adequate German language skills, assumed life-expectancy of ≥4 weeks, and cognitive ability for participation. ACP will be delivered by trained nurse facilitators of the respective home care services and communication will include proxy decision-makers. The primary endpoint will be patient activation, assessed by the Patient Activation Measure (PAM-13). Secondary endpoints include ACP-engagement, proportion of prepared advance directives, number and duration of hospitalisations, quality of life as well as depression and anxiety. Further, comprehensive economic and process evaluations will be conducted.
DISCUSSION
STADPLAN is the first study in Germany that assesses an adapted ACP intervention with trained nurses in home care services and the first international study focusing on cost effectiveness of ACP in community-dwelling older persons. The results will help to improve the understanding and communicating of patients' preferences regarding medical treatment and care and thereby contribute to patients' autonomy.
TRIAL REGISTRATION
German Clinical Trials Register: DRKS00016886 (Date of registration: 04.06.2019).",2020,"Secondary endpoints include ACP-engagement, proportion of prepared advance directives, number and duration of hospitalisations, quality of life as well as depression and anxiety.","['community-dwelling older persons', 'care dependent community-dwelling persons', 'Eligibility criteria for patients are: ≥60\u2009years, somehow care dependent, adequate German language skills, assumed life-expectancy of ≥4\u2009weeks, and cognitive ability for participation', 'care dependent community-dwelling older persons in Germany (STADPLAN', 'A cluster-randomised controlled trial of 12\u2009months duration will be conducted in 3 German study sites comparing the pretested']","['ACP-counselling offered by trained nurses with a control group receiving optimised usual care', 'ACP program', 'ACP', 'advance care planning']","['ACP-engagement, proportion of prepared advance directives, number and duration of hospitalisations, quality of life as well as depression and anxiety', 'patient activation, assessed by the Patient Activation Measure (PAM-13']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C4082130', 'cui_str': 'Prepared'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C2931826', 'cui_str': 'Potassium aggravated myotonia'}]",3.0,0.0667328,"Secondary endpoints include ACP-engagement, proportion of prepared advance directives, number and duration of hospitalisations, quality of life as well as depression and anxiety.","[{'ForeName': 'Rieke', 'Initials': 'R', 'LastName': 'Schnakenberg', 'Affiliation': 'Department of Health Services Research, Faculty of Medicine and Health Sciences, Carl von Ossietzky University Oldenburg, Oldenburg, Germany. rieke.schnakenberg@uol.de.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Silies', 'Affiliation': 'Institute for Social Medicine and Epidemiology, Nursing Research Unit, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Almuth', 'Initials': 'A', 'LastName': 'Berg', 'Affiliation': 'Medical Faculty, Institute for Health- and Nursing Science, Martin Luther University Halle-Wittenberg, Halle, Germany.'}, {'ForeName': 'Änne', 'Initials': 'Ä', 'LastName': 'Kirchner', 'Affiliation': 'Medical Faculty, Institute for Health- and Nursing Science, Martin Luther University Halle-Wittenberg, Halle, Germany.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Langner', 'Affiliation': 'Medical Faculty, Institute for Health- and Nursing Science, Martin Luther University Halle-Wittenberg, Halle, Germany.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Chuvayaran', 'Affiliation': 'Center for Health Economics and Health Services Research, Schumpeter School of Business and Economics, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Köberlein-Neu', 'Affiliation': 'Center for Health Economics and Health Services Research, Schumpeter School of Business and Economics, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Haastert', 'Affiliation': 'mediStatistica, Neuenrade, Germany.'}, {'ForeName': 'Birgitt', 'Initials': 'B', 'LastName': 'Wiese', 'Affiliation': 'Institute for General Practice, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': 'Medical Faculty, Institute for Health- and Nursing Science, Martin Luther University Halle-Wittenberg, Halle, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Köpke', 'Affiliation': 'Institute for Social Medicine and Epidemiology, Nursing Research Unit, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Health Services Research, Faculty of Medicine and Health Sciences, Carl von Ossietzky University Oldenburg, Oldenburg, Germany.'}]",BMC geriatrics,['10.1186/s12877-020-01537-4']
129,32303206,"In situ efficacy of an experimental toothpaste on enamel rehardening and prevention of demineralisation: a randomised, controlled trial.","BACKGROUND
A novel sodium fluoride toothpaste containing lactate ion and polyvinylmethylether-maleic anhydride has been developed to promote enamel remineralisation and resistance to demineralisation. In this in situ study, we compared this toothpaste ('Test') with a stannous fluoride-zinc citrate (SnF 2 -Zn) toothpaste ('Reference') (both 1100-1150 ppm fluoride) and a fluoride-free toothpaste ('Placebo') using an enamel dental erosion-rehardening model.
METHODS
In each phase of this randomised, investigator-blind, crossover study, participants wore palatal appliances holding bovine enamel specimens with erosive lesions. They brushed their natural teeth with either the Test, Reference or Placebo toothpastes, then swished the resultant slurry. Specimens were removed at 2 h and 4 h post-brushing and exposed to an in vitro acid challenge. Surface microhardness was measured at each stage; enamel fluoride uptake was measured after in situ rehardening. Surface microhardness recovery, relative erosion resistance, enamel fluoride uptake and acid resistance ratio were calculated at both timepoints.
RESULTS
Sixty two randomised participants completed the study. Test toothpaste treatment yielded significantly greater surface microhardness recovery, relative erosion resistance and enamel fluoride uptake values than either Reference or Placebo toothpastes after 2 and 4 h. The acid resistance ratio value for Test toothpaste was significantly greater than either of the other treatments after 2 h; after 4 h, it was significantly greater versus Placebo only. No treatment-related adverse events were reported.
CONCLUSIONS
In this in situ model, the novel-formulation sodium fluoride toothpaste enhanced enamel rehardening and overall protection against demineralisation compared with a fluoride-free toothpaste and a marketed SnF 2 -Zn toothpaste.
TRIAL REGISTRATION
ClinicalTrials.gov; NCT03296072; registered September 28, 2017.",2020,"Test toothpaste treatment yielded significantly greater surface microhardness recovery, relative erosion resistance and enamel fluoride uptake values than either Reference or Placebo toothpastes after 2 and 4 h.",['participants wore palatal appliances holding bovine enamel specimens with erosive lesions'],"[""stannous fluoride-zinc citrate (SnF 2 -Zn) toothpaste ('Reference') (both 1100-1150\u2009ppm fluoride) and a fluoride-free toothpaste ('Placebo"", 'Placebo toothpastes', 'Placebo', 'experimental toothpaste']","['adverse events', 'Surface microhardness recovery, relative erosion resistance, enamel fluoride uptake and acid resistance ratio', 'enamel fluoride uptake', 'surface microhardness recovery, relative erosion resistance and enamel fluoride uptake values', 'acid resistance ratio value for Test toothpaste', 'enamel rehardening and prevention of demineralisation']","[{'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C0772239', 'cui_str': 'ZINC CITRATE'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C4517537', 'cui_str': '1100'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1532109', 'cui_str': 'Ratio value'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0700185', 'cui_str': 'Decalcified structure'}]",62.0,0.45403,"Test toothpaste treatment yielded significantly greater surface microhardness recovery, relative erosion resistance and enamel fluoride uptake values than either Reference or Placebo toothpastes after 2 and 4 h.","[{'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Creeth', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. jonathan.e.creeth@gsk.com.""}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Burnett', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK.""}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Souverain', 'Affiliation': ""GSK Consumer Healthcare, Route de l'Etraz 2, 1260, Nyon, Switzerland.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Gomez-Pereira', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK.""}, {'ForeName': 'Domenick T', 'Initials': 'DT', 'LastName': 'Zero', 'Affiliation': 'Department of Cariology, Operative Dentistry and Dental Public Health and Oral Health Research Institute, Indiana University School of Dentistry, 415 Lansing Street, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lippert', 'Affiliation': 'Department of Cariology, Operative Dentistry and Dental Public Health and Oral Health Research Institute, Indiana University School of Dentistry, 415 Lansing Street, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Anderson T', 'Initials': 'AT', 'LastName': 'Hara', 'Affiliation': 'Department of Cariology, Operative Dentistry and Dental Public Health and Oral Health Research Institute, Indiana University School of Dentistry, 415 Lansing Street, Indianapolis, IN, 46202, USA.'}]",BMC oral health,['10.1186/s12903-020-01081-y']
130,31786177,Effectiveness of Tailored Dietary Counseling in Treating Malnourished Outpatients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial.,"BACKGROUND
Malnutrition in patients with chronic obstructive pulmonary disease (COPD) is common and associated with poor prognosis. Nutrition interventions are necessary, but there is a lack of evidence regarding the effectiveness of tailored nutrition advice.
OBJECTIVE
This study investigated whether tailored nutrition counseling could improve dietary intake, nutritional status, functional outcomes, and health-related quality of life (QoL) of malnourished outpatients with COPD.
DESIGN
We conducted a randomized controlled trial in which participants were randomly assigned to either the intervention group (IG) or the control group (CG).
PARTICIPANTS/SETTING
One hundred and twenty malnourished outpatients with COPD participated in the study between May and November 2017 at the National Lung Hospital, Hanoi, Vietnam.
INTERVENTION
The IG received tailored nutrition counseling once per month for 3 months based on a specifically developed written nutrition resource for COPD. The CG received the same educational resource at baseline without any discussion.
MAIN OUTCOME MEASURES
The main outcome measures were energy and protein intakes, body weight change, nutritional status (Subjective Global Assessment score), muscle strength, and QoL.
STATISTICAL ANALYSES
Differences between groups before and after the intervention were assessed using two-way repeated measures analysis of variance. Generalized estimating equation modeling was used to investigate the differences between groups over time.
RESULTS
At baseline, there were no significant differences in outcomes of interest between the two groups. After 3 months of intervention, time-intervention interactions for energy intake, protein intake, and body weight change were significant (945 kcal/day, 95% CI 792 to 1,099 kcal/day, P<0.001; 50.0 g protein/day, 95% CI 43.9 to 56.1 g protein/day, P<0.001; and 1.0 kg, 95% CI 0.5 to 1.5 kg, P<0.001, respectively). Subjective Global Assessment scores improved in the IG and worsened in the CG. Significant improvements were found in inspiratory muscle strength in the IG (5.4 cmH 2 O, 95% CI 2.3 to 8.6 cmH 2 O, P=0.001) and significant decreases in handgrip strength were found in the CG after 3 months of the intervention (1.4 kg, 95% CI 0.4 to 2.4 kg, P=0.007). There was a significant interaction effect for all QoL scores (analysis of variance two-way repeated, P≤0.003). The IG also significantly improved all QoL scores from baseline to 3 months (P<0.004).
CONCLUSIONS
Tailored nutritional counseling has the potential to improve dietary intakes, nutritional status, functional outcomes, and QoL in malnourished outpatients with COPD.",2020,Significant improvements were found in inspiratory muscle strength in the IG (,"['malnourished outpatients with COPD', 'One hundred and twenty malnourished outpatients with COPD participated in the study between May and November 2017 at the National Lung Hospital, Hanoi, Vietnam', 'patients with chronic obstructive pulmonary disease (COPD', 'Malnourished Outpatients with Chronic Obstructive Pulmonary Disease']","['intervention group (IG) or the control group (CG', 'Tailored Dietary Counseling', 'tailored nutrition counseling']","['inspiratory muscle strength', 'QoL scores', 'energy and protein intakes, body weight change, nutritional status (Subjective Global Assessment score), muscle strength, and QoL', 'handgrip strength', 'Subjective Global Assessment scores', 'dietary intakes, nutritional status, functional outcomes, and QoL', 'time-intervention interactions for energy intake, protein intake, and body weight change', 'dietary intake, nutritional status, functional outcomes, and health-related quality of life (QoL']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment (assessment scale)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.0888126,Significant improvements were found in inspiratory muscle strength in the IG (,"[{'ForeName': 'Ha Thanh', 'Initials': 'HT', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Toby G', 'Initials': 'TG', 'LastName': 'Pavey', 'Affiliation': ''}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Nhung Viet', 'Initials': 'NV', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Tuong Duy', 'Initials': 'TD', 'LastName': 'Pham', 'Affiliation': ''}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Gallegos', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.09.013']
131,31790884,The influence of ruminative processing mode on the trajectory of intrusive memories following a negative mood induction.,"BACKGROUND AND OBJECTIVES
Rumination following an event, particularly in an abstract as opposed to concrete processing mode, is associated with increased intrusive memory frequency. However, the temporal trajectory of intrusive memories following abstract and concrete rumination remains unclear. We examined the association between processing mode and the frequency of intrusive memories over a 6-h time period following a negative mood induction.
METHODS
One hundred and sixteen community participants watched a video sequence designed to induce negative mood. Participants were then randomised into condition (abstract, concrete or distraction) and completed a verbally mediated task designed to induce the respective processing mode. Participants then completed hourly ratings of rumination and intrusive memories about the video after leaving the laboratory.
RESULTS
Negative mood and intrusive memories were reliably induced. There were no differences in the frequency of intrusive memories between the abstract and concrete conditions. In contrast, participants in the distraction condition reported significantly more sensory intrusive memories than either ruminative condition. Three classes were found among participants following the video (intrusion free, rapid remitters, slow remitters). Condition was not predictive of class membership.
LIMITATIONS
It cannot be ruled out that the differences between rumination and distraction conditions were due to task differences.
CONCLUSIONS
In contrast to previous findings, our results suggest that any form of rumination about an event (whether in an abstract or concrete mode) may temporarily result in fewer intrusive memories in comparison to distraction. Processing mode does not appear to predict particular trajectories of intrusions following a mood induction.",2020,"Three classes were found among participants following the video (intrusion free, rapid remitters, slow remitters).",['One hundred and sixteen community participants watched a video sequence designed to induce negative mood'],"['condition (abstract, concrete or distraction) and completed a verbally mediated task designed to induce the respective processing mode']","['frequency of intrusive memories', 'Negative mood and intrusive memories', 'sensory intrusive memories']","[{'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0600678', 'cui_str': 'Abstracts'}, {'cui': 'C0557857', 'cui_str': 'Concrete (substance)'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories (finding)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}]",116.0,0.0343643,"Three classes were found among participants following the video (intrusion free, rapid remitters, slow remitters).","[{'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Stavropoulos', 'Affiliation': 'Discipline of Clinical Psychology, Graduate School of Health, University of Technology Sydney, NSW, Australia. Electronic address: adele.y.stavropoulos@student.uts.edu.au.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Berle', 'Affiliation': 'Discipline of Clinical Psychology, Graduate School of Health, University of Technology Sydney, NSW, Australia; School of Psychiatry, University of New South Wales, Sydney, NSW, Australia. Electronic address: david.berle@uts.edu.au.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101528']
132,31467314,Role of fundoplication in treatment of patients with symptoms of hiatal hernia.,"Gastroesophageal reflux disease (GERD) is often associated with hiatal hernia (HH). However, the need for fundoplication during hiatal hernia repair (HHR) remains controversial. The objective of this study was to evaluate the effect of HHR with concomitant laparoscopic Nissen fundoplication (HHR-LNF) in HH patients. A total of 122 patients with symptomatic HH were randomized to receive either HHR (n = 61) or HHR-LNF (n = 61). The measures of evaluating outcomes included DeMeester scores (DMS), complications, Reflux Diagnostic Questionnaire and patients' satisfaction 24 months following surgery. Despite comparable values in both groups at randomization, the DMS, total numbers of reflux episodes and percentage of time with pH < 4 were significantly higher in HHR group than in HHR-LNF group (P = 0.017, P = 0.002 and P = 0.019, respectively) at 6 months after surgery. One months postoperatively, complications were higher in the HHR-LNF group than in the HHR group (all P < 0.001), and there was no difference between the two groups at 6 months. By the end of the 2-year follow-up, HHR-LNF group showed a significantly lower reflux syndrome frequency-intensity score and greater percentage of satisfaction compared with HHR group (all P < 0.001). Laparoscopic HHR should be combined with a fundoplication in GERD patients with HH. HHR-LNF is safe and effective, not only improve reflux-related symptom, but also reduce the incidence of complications.",2019,"One months postoperatively, complications were higher in the HHR-LNF group than in the HHR group (all P < 0.001), and there was no difference between the two groups at 6 months.","['122 patients with symptomatic HH', 'Gastroesophageal reflux disease (GERD', 'patients with symptoms of hiatal hernia', 'HH patients', 'GERD patients with HH']","['HHR', 'Laparoscopic HHR', 'fundoplication', 'HHR-LNF', 'HHR with concomitant laparoscopic Nissen fundoplication (HHR-LNF']","[""DeMeester scores (DMS), complications, Reflux Diagnostic Questionnaire and patients' satisfaction 24 months following surgery"", 'reflux syndrome frequency-intensity score and greater percentage of satisfaction', 'DMS, total numbers of reflux episodes and percentage of time with pH\u2009<\u20094', 'complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3489393', 'cui_str': 'Hiatal Hernia'}]","[{'cui': 'C3887679', 'cui_str': 'Nissen Operation'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",122.0,0.0554797,"One months postoperatively, complications were higher in the HHR-LNF group than in the HHR group (all P < 0.001), and there was no difference between the two groups at 6 months.","[{'ForeName': 'Zhi-Tong', 'Initials': 'ZT', 'LastName': 'Li', 'Affiliation': ""Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': ""Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People's Republic of China. jifenggreat@126.com.""}, {'ForeName': 'Xin-Wei', 'Initials': 'XW', 'LastName': 'Han', 'Affiliation': ""Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People's Republic of China. xinweihanvip@126.com.""}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Yuan', 'Affiliation': ""Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People's Republic of China.""}, {'ForeName': 'Zheng-Yang', 'Initials': 'ZY', 'LastName': 'Wu', 'Affiliation': ""Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People's Republic of China.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ""Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People's Republic of China.""}, {'ForeName': 'De-Lu', 'Initials': 'DL', 'LastName': 'Peng', 'Affiliation': ""Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People's Republic of China.""}, {'ForeName': 'Zhong-Gao', 'Initials': 'ZG', 'LastName': 'Wang', 'Affiliation': ""Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People's Republic of China.""}]",Scientific reports,['10.1038/s41598-019-48740-x']
133,32013825,The Mediating Effect of Different Exercise Programs on the Immune Profile of Frail Older Women with Cognitive Impairment.,"BACKGROUND
Frail individuals experience an accelerated immunosenescence, and exercise has been identified as a therapy to promote a better inflammatory environment.
OBJECTIVE
To analyze the effects of 28-weeks of two different exercise protocols on the functional fitness and immune profiles of institutionalized pre-frail and frail women with mild cognitive impairment.
METHODS
Participants residing in care homes (n=60, 81±7.84 years old) were randomized into three groups: a chair elastic band muscle-strength exercise (CSE, n=21; 81±4.79), a chair multimodal exercise (CME, n=20; 80±8.19), and a control non-exercise (CGne, n=19; 80±10.01). Both CME and CSE groups performed progressive circuit-training exercise sessions. The controls did not change their usual lifestyle. The Fried protocol and the Mini-Mental State Examination questionnaire were used to identify the frail subgroups and the participants with mild cognitive impairment. Data for anti and pro-inflammatory markers and physical fitness were analyzed pre and post-interventions.
RESULTS
After the intervention, a significant effect of time and time by group for sIgA and time by group for IL- 10 levels were found (p > 0.05). Within-group analysis showed a significant moderate decrease in the TNF-α to IL-10 ratio for the CME group and an increase in the controls (p > 0.05) and a slight reduction in the IL-6 and IL- 1β concentrations. The controls showed a negative trend towards a decrease in physical fitness and a trend for increased levels in the pro-inflammatory markers IL-6 and IL-1β.
CONCLUSION
The evidence regarding the use of systematic and moderate long-term exercise as therapy for promoting a better balance between pro- and anti-inflammatory environments and a decrease in the inflammatory index for the CME group were the most promising results from this study.",2020,Within-group analysis showed a significant moderate decrease in the TNF-α to IL-10 ratio for the CME group and an increase in the controls (p > 0.05) and a slight reduction in the IL-6 and IL-1β concentrations.,"['Participants residing in care homes (n=60, 81±7.84 years old', 'institutionalized pre-frail and frail women with mild cognitive impairment', 'frail older women with cognitive impairment', 'participants with mild cognitive impairment']","['exercise protocols', 'control non-exercise', 'chair elastic band muscle-strength exercise (CSE', 'Mini Mental State Examination questionnaire', 'chair multimodal exercise (CME', 'exercise programs']","['TNF-α to IL-10 ratio', 'inflammatory index', 'IL-6 and IL-1β concentrations', 'functional fitness and immune profiles', 'physical fitness', 'IL-10 levels']","[{'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0419118', 'cui_str': 'Muscle strength exercise (regime/therapy)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0290119,Within-group analysis showed a significant moderate decrease in the TNF-α to IL-10 ratio for the CME group and an increase in the controls (p > 0.05) and a slight reduction in the IL-6 and IL-1β concentrations.,"[{'ForeName': 'Furtado G', 'Initials': 'FG', 'LastName': 'Eustáquio', 'Affiliation': 'Research Center for Sport and Physical Activity, CIDAF (UID/PTD/04213/2019), Faculty of Sports Sciences and Physical Education (FCDEF-UC) - University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Chupel M', 'Initials': 'CM', 'LastName': 'Uba', 'Affiliation': 'Research Center for Sport and Physical Activity, CIDAF (UID/PTD/04213/2019), Faculty of Sports Sciences and Physical Education (FCDEF-UC) - University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Minuzzi L', 'Initials': 'ML', 'LastName': 'Guerra', 'Affiliation': 'Research Center for Sport and Physical Activity, CIDAF (UID/PTD/04213/2019), Faculty of Sports Sciences and Physical Education (FCDEF-UC) - University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Luis', 'Affiliation': 'Research Center for Sport and Physical Activity, CIDAF (UID/PTD/04213/2019), Faculty of Sports Sciences and Physical Education (FCDEF-UC) - University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Colado J', 'Initials': 'CJ', 'LastName': 'Carlos', 'Affiliation': 'Reserch Unit in Sport and Health, Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Hogervorst', 'Initials': 'H', 'LastName': 'Eef', 'Affiliation': 'School of Sport and Exercise Sciences, Loughborough University, Leicestershire, United Kingdom.'}, {'ForeName': 'Ferreira J', 'Initials': 'FJ', 'LastName': 'Pedro', 'Affiliation': 'Research Center for Sport and Physical Activity, CIDAF (UID/PTD/04213/2019), Faculty of Sports Sciences and Physical Education (FCDEF-UC) - University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Teixeira A', 'Initials': 'TA', 'LastName': 'Maria', 'Affiliation': 'Research Center for Sport and Physical Activity, CIDAF (UID/PTD/04213/2019), Faculty of Sports Sciences and Physical Education (FCDEF-UC) - University of Coimbra, Coimbra, Portugal.'}]",Current pharmaceutical design,['10.2174/1381612826666200203123258']
134,32014535,Long-term (24h) cooling of ovarian fragments in the presence of permeable cryoprotectants prior to freezing: Two unsuccesful IVF-cycles and spontaneous pregnancy with baby born after re-transplantation.,"Cancer is the second major cause of death in the world. The problem of post-cancer infertility plays a significant role, because chemotherapy can be gonadotoxic. Cryopreservation of ovarian tissue before cancer therapy with re-implantation after convalescence is the potential key solution to this problem. The aim of this study was to test the viability of cryopreserved human ovarian cortex after long-term cooling in culture medium composed of permeable cryoprotectants. Ovarian fragments from sixteen patients were randomly divided into two groups. After the operation, tissue pieces assigned to both groups were cooled to 5 °C for 22-24 h, frozen and thawed. Group 1 pieces (n = 32) were cooled before cryopreservation in the standard culture medium, and Group 2 pieces (n = 32) were cooled in the freezing medium (culture medium+6% ethylene glycol+6% dimethyl sulfoxide+0.15 M sucrose). Freezing was performed in standard 5 ml cryo-vials with ice formation at -9 °C, cooling from -9 to -34 °C at a rate of -0.3 °C/min and plunging at -34 °C into liquid nitrogen. After thawing in a 100 °C (boiling) water bath, the removal of cryoprotectants was performed in 0.5 M sucrose with 20 min exposure in sucrose and 30 min stepping rehydration. The effectiveness of the pre-freezing cooling of tissue was evaluated by the development of follicles (histology). Six months after the autotransplantation, oocytes from the twenty-seven-year old, hormonally stimulated patient were retrieved and fertilized with her partner sperm through the intracytoplasmic spermatozoa injection (ICSI). For groups 1 and 2, 93.5 ± 1.9% and 96.4 ± 2.0% of the preantral follicles, respectively, were morphologically normal (P > 0.1) (with a tendency toward increasing in quality in Group 2). Six months after the auto-transplantation, two ICSI cycles resulted in the gathering and transplantation of high quality embryos, but no pregnancy had been established. Thirteen months after the auto-transplantation, the patient became spontaneously pregnant and delivered a healthy baby girl at term. Long-term (24 h) cooling of ovarian tissue to 5 °C before cryopreservation in the presence of permeable cryoprotectants simplifies the protocol of cryopreservation and has a tendency of increasing of the cells viability after thawing.",2020,"For groups 1 and 2, 93.5 ± 1.9% and 96.4 ± 2.0% of the preantral follicles, respectively, were morphologically normal (P > 0.1) (with a tendency toward increasing in quality in Group 2).",['Ovarian fragments from sixteen patients'],"['freezing medium (culture medium+6% ethylene glycol+6% dimethyl sulfoxide+0.15\xa0M sucrose', 'M sucrose with 20\xa0min exposure in sucrose and 30\xa0min stepping rehydration', 'ovarian tissue before cancer therapy with re-implantation']",[],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0015075', 'cui_str': 'Ethylene'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0034997', 'cui_str': 'Rehydration'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",[],32.0,0.034093,"For groups 1 and 2, 93.5 ± 1.9% and 96.4 ± 2.0% of the preantral follicles, respectively, were morphologically normal (P > 0.1) (with a tendency toward increasing in quality in Group 2).","[{'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Isachenko', 'Affiliation': 'University Maternal Hospital, Research Group for Reproductive Medicine and IVF-Laboratory, Department of Obstetrics and Genecology, Cologne University, Cologne, Germany. Electronic address: v.isachenko@yahoo.com.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Morgenstern', 'Affiliation': 'University Maternal Hospital, Research Group for Reproductive Medicine and IVF-Laboratory, Department of Obstetrics and Genecology, Cologne University, Cologne, Germany.'}, {'ForeName': 'Plamen', 'Initials': 'P', 'LastName': 'Todorov', 'Affiliation': 'Institute of Biology and Immunology of Reproduction, Sofia, Bulgaria.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Isachenko', 'Affiliation': 'University Maternal Hospital, Research Group for Reproductive Medicine and IVF-Laboratory, Department of Obstetrics and Genecology, Cologne University, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mallmann', 'Affiliation': 'University Maternal Hospital, Research Group for Reproductive Medicine and IVF-Laboratory, Department of Obstetrics and Genecology, Cologne University, Cologne, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hanstein', 'Affiliation': 'University Maternal Hospital, Research Group for Reproductive Medicine and IVF-Laboratory, Department of Obstetrics and Genecology, Cologne University, Cologne, Germany.'}, {'ForeName': 'Gohar', 'Initials': 'G', 'LastName': 'Rahimi', 'Affiliation': 'University Maternal Hospital, Research Group for Reproductive Medicine and IVF-Laboratory, Department of Obstetrics and Genecology, Cologne University, Cologne, Germany.'}]",Cryobiology,['10.1016/j.cryobiol.2020.01.022']
135,32333208,Modified Antiretroviral Treatment Access Study (MARTAS): A Randomized Controlled Trial of the Efficacy of a Linkage-to-Care Intervention Among HIV-Positive Patients in Ukraine.,"Between October 2015 and March 2018, we conducted the Modified Antiretroviral Treatment Access Study (MARTAS), a nurse-delivered case management intervention to improve linkage-to-care for persons recently tested HIV positive. Adult participants from nine urban clinics in three regions of Ukraine were randomized to either MARTAS or standard of care (SOC) using individual, parallel, two-arm design. The main study outcome was linkage-to-care (defined as registration at an HIV clinic) within a 3-month period from enrollment in the study. Intention-to-treat analysis of MARTAS (n = 135) versus SOC (n = 139) showed intervention efficacy in linkage to HIV care (84.4% vs. 33.8%; adjusted RR 2.45; 95% CI 1.72, 3.47; p < 0.001). MARTAS is recommended for implementation in Ukraine and may be helpful in other countries with similar gaps in linkage-to-care. Clinicaltrials.gov registration number: NCT02338024.",2020,MARTAS is recommended for implementation in Ukraine and may be helpful in other countries with similar gaps in linkage-to-care.,"['Adult participants from nine urban clinics in three regions of Ukraine', 'HIV-Positive Patients in Ukraine']","['nurse-delivered case management intervention to improve linkage-to-care for persons recently tested HIV positive', 'MARTAS or standard of care (SOC', 'Linkage-to-Care Intervention']","['intervention efficacy', 'linkage-to-care (defined as registration at an HIV clinic']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041580', 'cui_str': 'Ukraine'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",,0.271332,MARTAS is recommended for implementation in Ukraine and may be helpful in other countries with similar gaps in linkage-to-care.,"[{'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Neduzhko', 'Affiliation': 'Ukrainian Institute on Public Health Policy, 5 Mala Zhytomyrska str., Office 61A, Kiev, 01001, Ukraine. neduzhko@uiphp.org.ua.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Postnov', 'Affiliation': 'Ukrainian Institute on Public Health Policy, 5 Mala Zhytomyrska str., Office 61A, Kiev, 01001, Ukraine.'}, {'ForeName': 'Yuliia', 'Initials': 'Y', 'LastName': 'Sereda', 'Affiliation': 'Ukrainian Institute on Public Health Policy, 5 Mala Zhytomyrska str., Office 61A, Kiev, 01001, Ukraine.'}, {'ForeName': 'Roksolana', 'Initials': 'R', 'LastName': 'Kulchynska', 'Affiliation': 'Division of Global HIV and TB, U.S. Centers for Disease Control and Prevention, Kiev, Ukraine.'}, {'ForeName': 'Trista', 'Initials': 'T', 'LastName': 'Bingham', 'Affiliation': 'Division of Global HIV and TB, U.S. Centers for Disease Control and Prevention, Atlanta, USA.'}, {'ForeName': 'Janet J', 'Initials': 'JJ', 'LastName': 'Myers', 'Affiliation': 'Prevention Research Center, University of California, San Francisco, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Flanigan', 'Affiliation': 'Alpert Medical School, Brown University, Providence, USA.'}, {'ForeName': 'Tetiana', 'Initials': 'T', 'LastName': 'Kiriazova', 'Affiliation': 'Ukrainian Institute on Public Health Policy, 5 Mala Zhytomyrska str., Office 61A, Kiev, 01001, Ukraine.'}]",AIDS and behavior,['10.1007/s10461-020-02873-7']
136,32018030,Understanding the asthmatic response to an experimental rhinovirus infection: Exploring the effects of blocking IgE.,"BACKGROUND
Rhinovirus frequently causes asthma exacerbations among children and young adults who are allergic. The interaction between allergen and rhinovirus-induced symptoms and inflammation over time is unclear.
OBJECTIVE
Our aim was to compare the response to an experimental inoculation with rhinovirus-16 in allergic asthmatics with the response in healthy controls and to evaluate the effects of administrating omalizumab before and during the infection.
METHODS
Two clinical trials were run in parallel. In one of these trials, the response to an experimental inoculation with rhinovirus-16 among asthmatics with high levels of total IgE was compared to the response in healthy controls. The other trial compared the effects of administering omalizumab versus placebo to asthmatics in a randomized, double-blind placebo-controlled investigation. The primary outcome for both trials compared lower respiratory tract symptoms (LRTSs) between study groups over the first 4 days of infection.
RESULTS
Frequent comparisons of symptoms, lung function, and blood eosinophil counts revealed differences that were more pronounced among allergic asthmatics than among controls by days 2 and 3 after virus inoculation. Additionally, an augmentation of upper respiratory tract symptom scores and LRTS scores occurred among the atopic asthmatics versus the controls during the resolution of symptoms (P < .01 for upper respiratory symptom tract scores and P < .001 for LRTS scores). The beneficial effects of administering omalizumab on reducing LRTSs and improving lung function were strongest over the first 4 days.
CONCLUSIONS
LRTSs and blood eosinophil counts were augmented and lung function was reduced among allergic asthmatics early after rhinovirus inoculation but increased late in the infection during symptom resolution. The effect of administering omalizumab on the response to rhinovirus was most pronounced during the early/innate phase of the infection.",2020,Lower respiratory tract symptoms and blood eosinophil counts were augmented and lung function reduced among allergic asthmatics early after RV inoculation and increased late in the infection during symptom resolution.,"['Experimental Rhinovirus Infection', 'children and young adults who are allergic', 'allergic asthmatics and healthy controls']","['omalizumab', 'placebo', 'Blocking IgE']","['Lower respiratory tract symptoms and blood eosinophil counts', 'augmentation of upper and LRTS scores', 'symptoms, lung function and blood eosinophil counts', 'LRTS and improving lung function', 'lower respiratory tract symptoms (LRTS']","[{'cui': 'C0276447', 'cui_str': 'Disease due to Rhinovirus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0282335', 'cui_str': 'Respiratory Tract'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",,0.100517,Lower respiratory tract symptoms and blood eosinophil counts were augmented and lung function reduced among allergic asthmatics early after RV inoculation and increased late in the infection during symptom resolution.,"[{'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Heymann', 'Affiliation': 'Asthma and Allergic Diseases Center, University of Virginia, Charlottsville, Va; Division of Pediatric Respiratory Medicine, University of Virginia, Charlottsville, Va. Electronic address: pwh5a@virginia.edu.'}, {'ForeName': 'Thomas A E', 'Initials': 'TAE', 'LastName': 'Platts-Mills', 'Affiliation': 'Asthma and Allergic Diseases Center, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Woodfolk', 'Affiliation': 'Asthma and Allergic Diseases Center, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Borish', 'Affiliation': 'Asthma and Allergic Diseases Center, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Deborah D', 'Initials': 'DD', 'LastName': 'Murphy', 'Affiliation': 'Asthma and Allergic Diseases Center, University of Virginia, Charlottsville, Va; Division of Pediatric Respiratory Medicine, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Holliday T', 'Initials': 'HT', 'LastName': 'Carper', 'Affiliation': 'Asthma and Allergic Diseases Center, University of Virginia, Charlottsville, Va; Division of Pediatric Respiratory Medicine, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Conaway', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Steinke', 'Affiliation': 'Asthma and Allergic Diseases Center, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Lyndsey', 'Initials': 'L', 'LastName': 'Muehling', 'Affiliation': 'Asthma and Allergic Diseases Center, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Gerald Teague', 'Affiliation': 'Division of Pediatric Respiratory Medicine, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Kennedy', 'Affiliation': 'Division of Allergy and Immunology, University of Arkansas for Medical Sciences, Little Rock, Ark.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Irani', 'Affiliation': 'Division of Pediatric Allergy and Immunology, Virginia Commonwealth University, Richmond, Va.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'McGraw', 'Affiliation': 'Division of Pediatric Pulmonology, University of Rochester, Rochester, NY.'}, {'ForeName': 'Stephen V', 'Initials': 'SV', 'LastName': 'Early', 'Affiliation': 'Division of Pediatric Otolaryngology, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Wheatley', 'Affiliation': 'Allergy, Asthma and Airways Biology Branch, Division of Allergy, Immunology, and Transplantation/National Institute of Allergy and Infectious Diseases, Bethesda, Md.'}, {'ForeName': 'Amy P', 'Initials': 'AP', 'LastName': 'Adams', 'Affiliation': 'Department of Pharmacy, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Ronald B', 'Initials': 'RB', 'LastName': 'Turner', 'Affiliation': 'Department of Pediatric Infectious Diseases, University of Virginia, Charlottsville, Va.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.01.035']
137,32162495,Neural characteristics of cognitive reappraisal success and failure: An ERP study.,"INTRODUCTION
Cognitive reappraisal, an important strategy of emotion regulation, can change emotional experience and attention to emotional information. However, not all individuals can deploy reappraisal strategies successfully. In the current study, we investigated event-related potential (ERP) characteristics of reappraisal success and of reappraisal failure.
METHODS
Twenty-six participants were divided into the success group or the failure group based on self-report ratings of how successful they were in reducing their response to negative images using cognitive reappraisal strategy. All participants viewed 30 neutral images and 30 negative images which they were asked to just watch, and 30 negative stimuli that they were asked to reappraise, while electroencephalogram (EEG) was recorded.
RESULTS
The success group reported a significant reduction in the unpleasantness of negative images than the failure group in the negative-reappraisal condition. The ERP data indicated that two time windows differentiated between the success and failure groups. In 200-300 ms, P200 was significantly more positive to the negative-watch condition relative to both negative-reappraisal and neutral conditions in the failure group, while no difference was observed in the success group. In 300-5,000 ms, cognitive reappraisal led to increased late positive potential (LPP) relative to negative-watch in the early and middle latency windows (300-3,100 ms) in both groups; in the late latency window (3,100-5,000 ms), the reappraisal success group showed the LPP amplitude to the negative-reappraisal stimuli to be more positive than to the negative-watch stimuli, while no difference was found in the reappraisal failure group.
CONCLUSION
Our study provided direct evidence that different neurophysiological features were associated with reappraisal success and failure while engaging in the reappraisal of negative stimuli. This result will contribute to better understanding of the neural mechanism of emotion regulation in emotional disorders (i.e., depression and anxiety).",2020,The success group reported a significant reduction in the unpleasantness of negative images than the failure group in the negative-reappraisal condition.,['Twenty-six participants'],[],"['unpleasantness of negative images', 'LPP amplitude to the negative-reappraisal stimuli', 'late positive potential (LPP']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",26.0,0.0452556,The success group reported a significant reduction in the unpleasantness of negative images than the failure group in the negative-reappraisal condition.,"[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'Shanghai Institute for Advanced Communication and Data Science, School of Communication and Information Engineering, Qianweichang College, Shanghai University, Shanghai, China.'}, {'ForeName': 'Yingjie', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Shanghai Institute for Advanced Communication and Data Science, School of Communication and Information Engineering, Qianweichang College, Shanghai University, Shanghai, China.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Niznikiewicz', 'Affiliation': 'Laboratory of Cognitive Neuroscience, Boston VA Healthcare System, Brockton Division and Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}]",Brain and behavior,['10.1002/brb3.1584']
138,32162497,"A twelve-week, four-arm, randomized, double-blind, placebo-controlled, phase 2 prospective clinical trial to evaluate the efficacy and safety of an anthroposophic multimodal treatment on chronic pain in outpatients with postpolio syndrome.","INTRODUCTION
Chronic pain and fatigue are the main symptoms of postpoliomyelitis syndrome (PPS). This study aimed to evaluate the efficacy and safety of an anthroposophic multimodal treatment for chronic pain in PPS outpatients.
METHODS
A twelve-week, four-arm, randomized, double-blind, placebo-controlled, phase 2 prospective clinical trial was designed to compare four groups (n = 48): groups A and B received daily active experimental transdermal gel (ETG) or placebo gel (PTG), respectively; groups C and D received weekly external therapies, art therapies, and neurofunctional reorganization, plus either daily ETG or PTG, respectively. The pain symptoms were evaluated through a visual analogue scale (VAS), the McGill questionnaire, and thermography. Quality of life and resilience were evaluated by the WHOQOL-BREF and Antonovsky sense of coherence questionnaires applied at baseline and after the interventions.
RESULTS
No related adverse events occurred, and 10% of the patients reports dysphagia improvement. In the groups C and D, pain reduction was statistically significant in both the placebo group (p = .02, d = 1.315) and in the ETG (p = .005, d = 2.035). However, following the week-to-week evolution of pain with the concomitant use of the ETG, this significant pain reduction occurred earlier from the 4th week and continued to decrease (p = .016, d = 1.369). In the group that received the complete multimodal treatment, the greatest significant benefit in increasing quality of life occurred in the physical domain and elevation in resilience with an emphasis on meaning and comprehension domains.
CONCLUSIONS
The anthroposophic multimodal treatment group presented both safety and efficacy as an analgesic in the groups that received the nonpharmacological therapies, much earlier when associated with the ETG. The multimodal approach corresponded to the pattern of better efficacy for both pain reduction and improvement in quality of life and resilience.",2020,"In the groups C and D, pain reduction was statistically significant in both the placebo group (p = .02, d = 1.315) and in the ETG (p = .005, d = 2.035).","['four groups (n\xa0=\xa048', 'chronic pain in PPS outpatients', 'outpatients with postpolio syndrome', 'A twelve-week']","['anthroposophic multimodal treatment', 'placebo', 'daily active experimental transdermal gel (ETG) or placebo gel (PTG), respectively; groups C and D received weekly external therapies, art therapies, and neurofunctional reorganization, plus either daily ETG or PTG']","['adverse events', 'quality of life and resilience', 'visual analogue scale (VAS), the McGill questionnaire, and thermography', 'Quality of life and resilience', 'efficacy and safety', 'quality of life', 'Chronic pain and fatigue', 'WHOQOL-BREF and Antonovsky sense of coherence questionnaires', 'pain symptoms', 'pain reduction', 'chronic pain', 'safety and efficacy']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0080040', 'cui_str': 'Post-Polio Syndrome'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0009429', 'cui_str': 'Multimodal Treatment'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4707148', 'cui_str': 'Conventional release transdermal gel'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003827', 'cui_str': 'Art Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034380'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0039810', 'cui_str': 'Temperature Mapping'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3178983', 'cui_str': 'Salutogeneses'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.157865,"In the groups C and D, pain reduction was statistically significant in both the placebo group (p = .02, d = 1.315) and in the ETG (p = .005, d = 2.035).","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Ghelman', 'Affiliation': 'Department of Neurology, Universidade Federal de Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ivete Y', 'Initials': 'IY', 'LastName': 'Akiyama', 'Affiliation': 'Department of Neurology, Universidade Federal de Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Valeria T', 'Initials': 'VT', 'LastName': 'de Souza', 'Affiliation': 'Department of Neurology, Universidade Federal de Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jussara', 'Initials': 'J', 'LastName': 'Falcão', 'Affiliation': 'Department of Neurology, Universidade Federal de Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Orgolini', 'Affiliation': 'Department of Neurology, Universidade Federal de Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jorge K', 'Initials': 'JK', 'LastName': 'Hosomi', 'Affiliation': 'Department of Obstetrics, Universidade Federal de Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Abrahão A J', 'Initials': 'AAJ', 'LastName': 'Quadros', 'Affiliation': 'Department of Neurology, Universidade Federal de Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Acary S B', 'Initials': 'ASB', 'LastName': 'Oliveira', 'Affiliation': 'Department of Neurology, Universidade Federal de Sao Paulo, São Paulo, Brazil.'}]",Brain and behavior,['10.1002/brb3.1590']
139,32302646,Acute stress affects implicit but not explicit motor imagery: A pilot study.,"Motor imagery (MI) is the capacity to mentally perform one or a set of movements without concomitant overt action. MI training has been show to enhance the subsequent motor performance. While the benefits of MI to manage stress have been extensively documented, the reverse impact of stress on MI received far less attention. The present study thus aimed to evaluate whether acute stress might influence MI abilities. Thirty participants were assigned either to a stress or a control group. The Socially Evaluated Cold Pressor Test (SECPT) was used to induce stress, with heart rate, electrodermal activity, salivary cortisol, and self-report perceived levels of stress being monitored during the experiment. Stress induction was followed by both implicit (laterality judgment) and explicit (sequential pointing) MI tasks. Main results showed a deleterious impact of stress on implicit MI, while explicit MI was not altered. These exploratory findings provide a deeper understanding of stress effects on cognition, and practically support that under stressful conditions, as during a sport competition or rehabilitation contexts, explicit MI should be prioritized.",2020,"Main results showed a deleterious impact of stress on implicit MI, while explicit MI was not altered.",['Thirty participants'],"['explicit motor imagery', 'Motor imagery (MI', 'MI training']","['induce stress, with heart rate, electrodermal activity, salivary cortisol, and self-report perceived levels of stress', 'deleterious impact of stress on implicit MI, while explicit MI']","[{'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]",30.0,0.0137573,"Main results showed a deleterious impact of stress on implicit MI, while explicit MI was not altered.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Schlatter', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: sophie.schlatter@univ-lyon1.fr.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Guillot', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: aymeric.guillot@univ-lyon1.fr.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Faes', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: camille.faes@univ-lyon1.fr.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Saruco', 'Affiliation': 'Neurologische Universitätsklinik, Bergmannsheil gGmbH, Forschungsgruppe Plastizität, Bürkle-de-la-Camp-Platz 1, 44789 Bochum, Germany. Electronic address: elodie.saruco@ruhr-uni-bochum.de.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Collet', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: christian.collet@univ-lyon1.fr.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Di Rienzo', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: franck.di-rienzo@univ-lyon1.fr.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Debarnot', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: ursula.debarnot@univ-lyon1.fr.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.04.011']
140,32321478,Reducing expectations for antibiotics in primary care: a randomised experiment to test the response to fear-based messages about antimicrobial resistance.,"BACKGROUND
To reduce inappropriate antibiotic use, public health campaigns often provide fear-based information about antimicrobial resistance (AMR). Meta-analyses have found that fear-based campaigns in other contexts are likely to be ineffective unless respondents feel confident they can carry out the recommended behaviour ('self-efficacy'). This study aimed to test the likely impact of fear-based messages, with and without empowering self-efficacy elements, on patient consultations/antibiotic requests for influenza-like illnesses, using a randomised design.
METHODS
We hypothesised that fear-based messages containing empowering information about self-management without antibiotics would be more effective than fear alone, particularly in a pre-specified subgroup with low AMR awareness. Four thousand respondents from an online panel, representative of UK adults, were randomised to receive three different messages about antibiotic use and AMR, designed to induce fear about AMR to varying degrees. Two messages (one 'strong-fear', one 'mild-fear') also contained empowering information regarding influenza-like symptoms being easily self-managed without antibiotics. The main outcome measures were self-reported effect of information on likelihood of visiting a doctor and requesting antibiotics, for influenza-like illness, analysed separately according to whether or not the AMR information was 'very/somewhat new' to respondents, pre-specified based on a previous (non-randomised) survey.
RESULTS
The 'fear-only' message was 'very/somewhat new' to 285/1000 (28.5%) respondents, 'mild-fear-plus-empowerment' to 336/1500 (22.4%), and 'strong-fear-plus-empowerment' to 388/1500 (25.9%) (p = 0.002). Of those for whom the respective information was 'very/somewhat new', only those given the 'strong-fear-plus-empowerment' message said they would be less likely to request antibiotics if they visited a doctor for an influenza-like illness (p < 0.0001; 182/388 (46.9%) 'much less likely'/'less likely', versus 116/336 (34.5%) with 'mild-fear-plus-empowerment' versus 85/285 (29.8%) with 'fear-alone'). Those for whom the respective information was not 'very/somewhat new' said they would be less likely to request antibiotics for influenza-like illness (p < 0.0001) across all messages (interaction p < 0.0001 versus 'very/somewhat new' subgroup). The three messages had analogous self-reported effects on likelihood of visiting a doctor and in subgroups defined by believing antibiotics would 'definitely/probably' help an influenza-like illness. Results were reproduced in an independent randomised survey (additional 4000 adults).
CONCLUSIONS
Fear could be effective in public campaigns to reduce inappropriate antibiotic use, but should be combined with messages empowering patients to self-manage symptoms effectively without antibiotics.",2020,The three messages had analogous self-reported effects on likelihood of visiting a doctor and in subgroups defined by believing antibiotics would 'definitely/probably' help an influenza-like illness.,"['primary care', 'Four thousand respondents from an online panel, representative of UK adults']",[],"['self-reported effect of information on likelihood of visiting a doctor and requesting antibiotics, for influenza-like illness']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}]",4000.0,0.0931366,The three messages had analogous self-reported effects on likelihood of visiting a doctor and in subgroups defined by believing antibiotics would 'definitely/probably' help an influenza-like illness.,"[{'ForeName': 'Laurence S J', 'Initials': 'LSJ', 'LastName': 'Roope', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tonkin-Crine', 'Affiliation': 'The National Institute for Health Research Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford, Oxford, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Herd', 'Affiliation': 'Centre for Behaviour Change, University College London, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Michie', 'Affiliation': 'Centre for Behaviour Change, University College London, London, UK.'}, {'ForeName': 'Koen B', 'Initials': 'KB', 'LastName': 'Pouwels', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Castro-Sanchez', 'Affiliation': 'NIHR Health Protection Research Unit, Healthcare Associated Infection and Antimicrobial Resistance at Imperial College, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sallis', 'Affiliation': 'Public Health England, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hopkins', 'Affiliation': 'The National Institute for Health Research Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford, Oxford, UK.'}, {'ForeName': 'Julie V', 'Initials': 'JV', 'LastName': 'Robotham', 'Affiliation': 'The National Institute for Health Research Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford, Oxford, UK.'}, {'ForeName': 'Derrick W', 'Initials': 'DW', 'LastName': 'Crook', 'Affiliation': 'The National Institute for Health Research Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford, Oxford, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'The National Institute for Health Research Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford, Oxford, UK.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Peters', 'Affiliation': 'Health Services Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'The National Institute for Health Research Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford, Oxford, UK.'}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'The National Institute for Health Research Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wordsworth', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK. sarah.wordsworth@ndph.ox.ac.uk.'}]",BMC medicine,['10.1186/s12916-020-01553-6']
141,32326082,"Mindfulness versus Physical Exercise: Effects of Two Recovery Strategies on Mental Health, Stress and Immunoglobulin A during Lunch Breaks. A Randomized Controlled Trial.","This research analyses the effects of mindfulness meditation (MM) and physical exercise (PE), practised as daily recovery activities during lunch breaks, on perceived stress, general mental health, and immunoglobin A (IgA). A three-armed randomized controlled trial with 94 employees was conducted for five weeks including two follow-up sessions after one and six months. Daily practice lasted 30 min maximum. Perceived stress and general mental health questionnaires and saliva samples were used. There were significant differences in time factor comparing pre- and post-test of Perceived Stress Questionnaire (PSQ) both for PE [Mdiff = 0.10, SE = 0.03, p = 0.03], and for MM [Mdiff = 0.09, SE = 0.03, p = 0.03]. Moreover, there were significant differences of interaction factor when comparing MM vs. PE in total score at pre-post [F = -2.62 (6, 168.84), p = 0.02, ω 2 = 0.09], favoring PE with medium and high effect sizes. Regarding General Health Questionnaire (GHQ) variable, practicing MM showed significant effects in time factor compared to pre-Fup2. No significant differences were found for IgA. Thus, practicing both MM and PE as recovery strategies during lunch breaks could reduce perceived stress after five weeks of practice, with better results for PE. Moreover, practicing MM could improve mental health with effects for 6 months.",2020,"There were significant differences in time factor comparing pre- and post-test of Perceived Stress Questionnaire (PSQ) both for PE [Mdiff = 0.10, SE = 0.03, p = 0.03], and for MM [Mdiff = 0.09, SE = 0.03, p = 0.03].",['94 employees'],"['Mindfulness versus Physical Exercise', 'mindfulness meditation (MM) and physical exercise (PE']","['mental health', 'Mental Health, Stress and Immunoglobulin A during Lunch Breaks', 'time factor comparing pre- and post-test of Perceived Stress Questionnaire (PSQ', 'perceived stress, general mental health, and immunoglobin A (IgA', 'Perceived stress and general mental health questionnaires and saliva samples']","[{'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0040225', 'cui_str': 'Time Factors'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",94.0,0.120693,"There were significant differences in time factor comparing pre- and post-test of Perceived Stress Questionnaire (PSQ) both for PE [Mdiff = 0.10, SE = 0.03, p = 0.03], and for MM [Mdiff = 0.09, SE = 0.03, p = 0.03].","[{'ForeName': 'Cintia', 'Initials': 'C', 'LastName': 'Díaz-Silveira', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, Universidad Rey Juan Carlos, Avda. Atenas s/n, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Carlos-María', 'Initials': 'CM', 'LastName': 'Alcover', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, Universidad Rey Juan Carlos, Avda. Atenas s/n, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Burgos', 'Affiliation': 'Faculty of Psychology, Universidad Nacional de Educación a Distancia, c/Juan del Rosal 10, 29040 Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Marcos', 'Affiliation': 'Faculty of Psychology, Universidad Nacional de Educación a Distancia, c/Juan del Rosal 10, 29040 Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Santed', 'Affiliation': 'Faculty of Psychology, Universidad Nacional de Educación a Distancia, c/Juan del Rosal 10, 29040 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17082839']
142,32327087,Optimal Timing of Intervention in NSTE-ACS Without Pre-Treatment: The EARLY Randomized Trial.,"OBJECTIVES
The aim of this study was to compare a delayed and a very early invasive strategy in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) without pre-treatment.
BACKGROUND
The optimal delay of the invasive strategy in patients with NSTE-ACS remains debated and has never been investigated in patients not pre-treated with P2Y 12 -adenosine diphosphate receptor antagonists.
METHODS
A prospective, open-label, randomized controlled trial was conducted. Altogether, 741 patients presenting with intermediate- or high-risk NSTE-ACS intended for an invasive strategy were included. The modified intention-to-treat analysis was composed of 709 patients after 32 withdrew consent. Patients were randomized 1:1 to the delayed invasive group (DG) (n = 363) with coronary angiography (CA) performed 12 to 72 h after randomization or the very early invasive group (EG) (n = 346) with CA within 2 h. No pre-treatment with a loading dose of a P2Y 12 -adenosine diphosphate receptor antagonist was allowed before CA. The primary endpoint was the composite of cardiovascular death and recurrent ischemic events at 1 month, as determined by a blinded adjudication committee.
RESULTS
Most patients had high-risk NSTE-ACS in both groups (93% in the EG vs. 92.5% in the DG). The median time between randomization and CA was 0 h (interquartile range [IQR]: 0 to 1 h) in the EG group and 18 h (IQR: 11 to 23 h) in the DG. The primary endpoint rate was significantly lower in the EG (4.4% vs. 21.3% in the DG; hazard ratio: 0.20; 95% confidence interval: 0.11 to 0.34; p < 0.001), driven by a reduction in recurrent ischemic events (19.8% vs. 2.9%; p < 0.001). No difference was observed for cardiovascular death.
CONCLUSIONS
Without pre-treatment, a very early invasive strategy was associated with a significant reduction in ischemic events at the time of percutaneous coronary intervention in patients with intermediate- and high-risk NSTE-ACS. (Early or Delayed Revascularization for Intermediate and High-Risk Non ST-Elevation Acute Coronary Syndromes; NCT02750579).",2020,"The primary endpoint rate was significantly lower in the EG (4.4% vs. 21.3% in the DG; hazard ratio: 0.20; 95% confidence interval: 0.11 to 0.34; p < 0.001), driven by a reduction in recurrent ischemic events (19.8% vs. 2.9%; p < 0.001).","['709 patients after 32 withdrew consent', '741 patients presenting with intermediate- or high-risk NSTE-ACS intended for an invasive strategy were included', 'patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS']",['delayed invasive group (DG) (n\xa0=\xa0363) with coronary angiography (CA) performed 12 to 72\xa0h after randomization or the very early invasive group (EG'],"['ischemic events', 'recurrent ischemic events', 'composite of cardiovascular death and recurrent ischemic events', 'median time', 'cardiovascular death', 'high-risk NSTE-ACS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}]",741.0,0.0563662,"The primary endpoint rate was significantly lower in the EG (4.4% vs. 21.3% in the DG; hazard ratio: 0.20; 95% confidence interval: 0.11 to 0.34; p < 0.001), driven by a reduction in recurrent ischemic events (19.8% vs. 2.9%; p < 0.001).","[{'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Lemesle', 'Affiliation': ""USIC et Centre Hémodynamique, Institut Cœur Poumon, Centre Hospitalier Universitaire de Lille, Lille, France; Faculté de Médecine de l'Université de Lille, Lille, France; INSERM UMR 1011, Institut Pasteur de Lille, Lille, France; French Alliance for Cardiovascular Trials, Paris, France.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Aix-Marseille Université, Intensive Care Unit, Department of Cardiology, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology, Marseille, France; Centre for CardioVascular and Nutrition Research, INSERM 1263, INRA 1260, Marseille, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Pankert', 'Affiliation': 'Service de Cardiologie, Centre Hospitalier Henri Duffaut, Avignon, France.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Boueri', 'Affiliation': 'Service de Cardiologie, Centre Hospitalier de Bastia, Bastia, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Motreff', 'Affiliation': 'Département de Cardiologie, Centre Hospitalier Universitaire Gabriel Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Paganelli', 'Affiliation': 'Aix-Marseille Université, Intensive Care Unit, Department of Cardiology, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology, Marseille, France; Centre for CardioVascular and Nutrition Research, INSERM 1263, INRA 1260, Marseille, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Baumstarck', 'Affiliation': ""Unité d'Aide Méthodologique à la Recherche Clinique, EA 3279, Laboratoire de Santé Publique, Aix-Marseille Université, Marseille, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Roch', 'Affiliation': ""Hôpital Nord, Marseille, France; Service d'Accueil des Urgences, Hôpital Nord, Marseille, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Kerbaul', 'Affiliation': 'Pole RUSH, Assistance-Publique Hôpitaux de Marseille, UMR MD2 - Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Puymirat', 'Affiliation': 'Département de Cardiologie, Hôpital Européen Georges Pompidou, Assistance Publique des Hôpitaux de Paris, Paris, France; Université Paris Descartes, INSERM U-970, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bonello', 'Affiliation': 'Aix-Marseille Université, Intensive Care Unit, Department of Cardiology, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology, Marseille, France; Centre for CardioVascular and Nutrition Research, INSERM 1263, INRA 1260, Marseille, France. Electronic address: laurent.bonello@ap-hm.fr.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.01.231']
143,32327093,"BMI, Infarct Size, and Clinical Outcomes Following Primary PCI: Patient-Level Analysis From 6 Randomized Trials.","OBJECTIVES
The aim of this study was to examine the association between body mass index (BMI), infarct size (IS) and clinical outcomes.
BACKGROUND
The association between obesity, IS, and prognosis in patients undergoing primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction is incompletely understood.
METHODS
An individual patient-data pooled analysis was performed from 6 randomized trials of patients undergoing pPCI for ST-segment elevation myocardial infarction in which IS (percentage left ventricular mass) was assessed within 1 month (median 4 days) after randomization using either cardiac magnetic resonance (5 studies) or 99m Tc sestamibi single-photon emission computed tomography (1 study). Patients were classified as normal weight (BMI <25 kg/m 2 ), overweight (25 kg/m 2 ≤BMI <30 kg/m 2 ), or obese (BMI ≥30 kg/m 2 ). The multivariable models were adjusted for age, sex, hypertension, hyperlipidemia, current smoking, left main or left anterior descending coronary artery infarct, baseline TIMI (Thrombolysis In Myocardial Infarction) flow grade 0 or 1, prior myocardial infarction, symptom-to-first device time, and study.
RESULTS
Among 2,238 patients undergoing pPCI, 644 (29%) were normal weight, 1,008 (45%) were overweight, and 586 (26%) were obese. BMI was not significantly associated with IS, microvascular obstruction, or left ventricular ejection fraction in adjusted or unadjusted analysis. BMI was also not associated with the 1-year composite risk for death or heart failure hospitalization (adjusted hazard ratio: 1.21 [95% confidence interval: 0.74 to 1.71] for overweight vs. normal [p = 0.59]; adjusted hazard ratio: 1.21 [95% confidence interval 0.74 to 1.97] for obese vs. normal [p = 0.45]) or for death or heart failure hospitalization separately. Results were consistent when BMI was modeled as a continuous variable.
CONCLUSIONS
In this individual patient-data pooled analysis of 2,238 patients undergoing pPCI for ST-segment elevation myocardial infarction, BMI was not associated with IS, microvascular obstruction, left ventricular ejection fraction, or 1-year rates of death or heart failure hospitalization.",2020,"BMI was not significantly associated with IS, microvascular obstruction, or left ventricular ejection fraction in adjusted or unadjusted analysis.","['patients undergoing primary percutaneous\xa0coronary intervention (pPCI) for ST-segment elevation myocardial infarction', '2,238 patients undergoing pPCI, 644 (29%) were normal weight, 1,008 (45%) were overweight, and 586 (26%) were obese', 'patients undergoing pPCI for ST-segment elevation myocardial infarction in which IS (percentage left ventricular mass', 'left anterior descending coronary artery infarct, baseline TIMI (Thrombolysis In Myocardial Infarction) flow grade 0 or 1, prior myocardial infarction, symptom-to-first device time, and study', 'Patients were classified as normal weight (BMI\xa0<25\xa0kg/m 2 ), overweight (25\xa0kg/m 2 \xa0≤BMI\xa0<30\xa0kg/m 2 ), or obese (BMI\xa0≥30\xa0kg/m 2 ', '2,238 patients undergoing']","['pPCI', 'Primary PCI', 'cardiac magnetic resonance (5 studies) or 99m Tc sestamibi single-photon emission computed tomography']","['1-year composite risk for death or heart failure hospitalization', 'death or heart failure hospitalization separately', 'body mass index (BMI), infarct size (IS) and clinical outcomes', 'IS, microvascular obstruction, or left ventricular ejection fraction', 'BMI', 'BMI, Infarct Size, and Clinical Outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0162680', 'cui_str': 'Technetium Tc 99m Sestamibi'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",2238.0,0.173923,"BMI was not significantly associated with IS, microvascular obstruction, or left ventricular ejection fraction in adjusted or unadjusted analysis.","[{'ForeName': 'Bahira', 'Initials': 'B', 'LastName': 'Shahim', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York; Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Eitel', 'Affiliation': 'University Heart Center Lübeck and the German Center for Cardiovascular Research, Lübeck, Germany.'}, {'ForeName': 'Fotis', 'Initials': 'F', 'LastName': 'Gkargkoulas', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Crowley', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: gstone@crf.org.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.02.004']
144,32090389,The neural correlates of mindfulness-induced depression reduction in adults with autism spectrum disorder: A pilot study.,"Adults with autism spectrum disorder (ASD) experience high rates of depression and anxiety, and some evidence suggests mindfulness-based stress reduction (MBSR) is effective in reducing these symptoms. However, the neural mechanisms of symptom alleviation, and benefit of MBSR beyond education/support groups are unknown. Maladaptive forms of self-reflection are linked to ASD, depression, and anxiety. In this pilot study, we hypothesized (a) MBSR would reduce depression and anxiety in adults with ASD and (b) a mechanism of symptom alleviation would be increased blood oxygen level-dependent signal in neural self-reflection hubs. Twenty-eight adults were randomly assigned to an 8-week MBSR group (n = 15) or a support group (n = 13) that met for the same amount of time with relaxation education materials. Based on previous self-reflection literature in ASD, regions of interest (ROIs) were middle cingulate cortex (MCC) and ventromedial prefrontal cortex (vmPFC). Only the MBSR group demonstrated significant reductions in depression, and neither group significantly changed in anxiety. Only the MBSR group increased activity of right MCC during self-reflection, and the increase correlated with depression alleviation. There were no changes in vmPFC for the MBSR group or either ROI for the support/education group. Seed-to-voxel connectivity analysis revealed that only the MBSR group increased functional connectivity between right MCC and pre/postcentral gyrus, suggesting MBSR may increase primary sensorimotor input to higher order cognitive brain regions. Taken together, MBSR may be effective for reducing depression in adults with ASD, and the neural mechanism may be increasing frontal circuit involvement during self-directed thought.",2020,"Only the MBSR group increased activity of right MCC during self-reflection, and the increase correlated with depression alleviation.","['Twenty-eight adults', 'adults with ASD', 'adults with ASD and (b', 'Adults with autism spectrum disorder (ASD', 'adults with autism spectrum disorder']",['MBSR'],"['anxiety', 'depression alleviation', 'activity of right MCC', 'depression and anxiety', 'functional connectivity', 'vmPFC', 'depression']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",28.0,0.0144736,"Only the MBSR group increased activity of right MCC during self-reflection, and the increase correlated with depression alleviation.","[{'ForeName': 'Broc A', 'Initials': 'BA', 'LastName': 'Pagni', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Melissa J M', 'Initials': 'MJM', 'LastName': 'Walsh', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Foldes', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Sebren', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Maria V', 'Initials': 'MV', 'LastName': 'Dixon', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Guerithault', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'B Blair', 'Initials': 'BB', 'LastName': 'Braden', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}]",Journal of neuroscience research,['10.1002/jnr.24600']
145,32270927,Time-Restricted Eating Effects on Body Composition and Metabolic Measures in Humans who are Overweight: A Feasibility Study.,"OBJECTIVE
In contrast to intentionally restricting energy intake, restricting the eating window may be an option for treating obesity. By comparing time-restricted eating (TRE) with an unrestricted (non-TRE) control, it was hypothesized that TRE facilitates weight loss, alters body composition, and improves metabolic measures.
METHODS
Participants (17 women and 3 men; mean [SD]: 45.5 [12.1] years; BMI 34.1 [7.5] kg/m 2 ) with a prolonged eating window (15.4 [0.9] hours) were randomized to TRE (n = 11: 8-hour window, unrestricted eating within window) versus non-TRE (n = 9: unrestricted eating) for 12 weeks. Weight, body composition (dual x-ray absorptiometry), lipids, blood pressure, 2-hour oral glucose tolerance, 2-week continuous glucose monitoring, and 2-week physical activity (actigraphy assessed) were measured during the pre- and end-intervention periods.
RESULTS
The TRE group significantly reduced the eating window (end-intervention window: 9.9 [2.0] hours) compared with the non-TRE group (end-intervention window: 15.1 [1.1] hours) (P < 0.01). Compared with non-TRE, TRE decreased the number of eating occasions, weight, lean mass, and visceral fat (all P ≤ 0.05). Compared with preintervention measures, the TRE group reduced the number of eating occasions (-21.9% [30.1%]) and reduced weight (-3.7% [1.8%]), fat mass (-4% [2.9%]), lean mass (-3.0% [2.7%]), and visceral fat (-11.1% [13.4%]) (all P ≤ 0.05). Physical activity and metabolic measures remained unchanged.
CONCLUSIONS
In the setting of a randomized trial, TRE presents a simplified view of food intake that reduces weight.",2020,"Compared with preintervention measures, the TRE group reduced the number of eating occasions (-21.9% [30.1%]) and reduced weight (-3.7% [1.8%]), fat mass (-4% [2.9%]), lean mass (-3.0% [2.7%]), and visceral fat (-11.1% [13.4%]) (all P ≤ 0.05).","['Participants (17 women and 3 men; mean [SD]: 45.5 [12.1] years; BMI 34.1 [7.5] kg/m 2 ) with a prolonged eating window (15.4 [0.9] hours', 'Humans with Overweight']","['TRE', 'TRE (n\u2009=\u200911: 8-hour window, unrestricted eating within window) versus non-TRE']","['reduced weight', 'weight loss, alters body composition, and improves metabolic measures', 'visceral fat', 'number of eating occasions, weight, lean mass, and visceral fat', 'number of eating occasions', 'fat mass', 'Body Composition and Metabolic Measures', 'Weight, body composition (dual x-ray absorptiometry), lipids, blood pressure, 2-hour oral glucose tolerance, 2-week continuous glucose monitoring, and 2-week physical activity (actigraphy assessed', 'lean mass', 'eating window', 'Physical activity and metabolic measures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C4517579', 'cui_str': '15.4'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0557702', 'cui_str': 'Window'}]",17.0,0.0340305,"Compared with preintervention measures, the TRE group reduced the number of eating occasions (-21.9% [30.1%]) and reduced weight (-3.7% [1.8%]), fat mass (-4% [2.9%]), lean mass (-3.0% [2.7%]), and visceral fat (-11.1% [13.4%]) (all P ≤ 0.05).","[{'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Chow', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Emily N C', 'Initials': 'ENC', 'LastName': 'Manoogian', 'Affiliation': 'Salk Institute for Biological Studies, La Jolla, California, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Alvear', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Fleischer', 'Affiliation': 'Salk Institute for Biological Studies, La Jolla, California, USA.'}, {'ForeName': 'Honoree', 'Initials': 'H', 'LastName': 'Thor', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Dietsche', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Hodges', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Esch', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Malaeb', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Tasma', 'Initials': 'T', 'LastName': 'Harindhanavudhi', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'K Sreekumaran', 'Initials': 'KS', 'LastName': 'Nair', 'Affiliation': 'Division of Endocrinology, Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA.'}, {'ForeName': 'Satchidananda', 'Initials': 'S', 'LastName': 'Panda', 'Affiliation': 'Salk Institute for Biological Studies, La Jolla, California, USA.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'Mashek', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22756']
146,31586170,Comment on: A trial of a mechanical device for the treatment of blepharospasm.,,2020,,[],['mechanical device'],[],[],"[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",[],,0.0269564,,"[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Go', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Anderson', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Kini', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Bayan', 'Initials': 'B', 'LastName': 'Al Othman', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Lee', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA. aglee@houstonmethodist.org.'}]","Eye (London, England)",['10.1038/s41433-019-0621-x']
147,30762156,Evaluation of a Bystander-Focused Interpersonal Violence Prevention Program with High School Students.,"This study evaluated the effectiveness of a seven-session, bystander-focused, classroom-delivered curriculum (i.e., Bringing in the Bystander-High School Curriculum [BITB-HSC]) in reducing rates of interpersonal violence among high school students. High schools (N = 26) were randomly assigned to the treatment or control condition. In classrooms in treatment schools, students (n = 1081) completed a baseline survey, participated in the BITB-HSC, and completed an immediate post-test, a short-term post-test (approx. 2 months after intervention), and a long-term post-test (approx. 1 year after intervention). Youth in control schools (n = 1322) completed surveys at similar time points but did not participate in the BITB-HSC. Participants were 15.8 years old on average and largely White (85.1%) and heterosexual (84.5%). Students exposed to the BITB-HSC demonstrated significant short-term changes in victim empathy and bystander barriers/facilitators, and long-term changes in rape myths, media literacy, bystander readiness, and knowledge relative to youth in the control condition. Although the BITB-HSC had little long-term impact on actual bystander behavior, there were reductions in some forms of violence among students in the BITB-HSC condition relative to the control condition. Future research is needed to determine if, for whom, why, and in what contexts (e.g., classroom-based versus school-wide initiatives) bystander-focused violence prevention initiatives reduce violence.",2019,"Students exposed to the BITB-HSC demonstrated significant short-term changes in victim empathy and bystander barriers/facilitators, and long-term changes in rape myths, media literacy, bystander readiness, and knowledge relative to youth in the control condition.","['High schools (N\u2009=\u200926', 'Participants were 15.8\xa0years old on average and largely White (85.1%) and heterosexual (84.5', 'high school students', 'High School Students']","['seven-session, bystander-focused, classroom-delivered curriculum (i.e., Bringing in the Bystander-High School Curriculum [BITB-HSC', 'Bystander-Focused Interpersonal Violence Prevention Program']","['rates of interpersonal violence', 'victim empathy and bystander barriers/facilitators, and long-term changes in rape myths, media literacy, bystander readiness, and knowledge relative to youth', 'actual bystander behavior']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0330502', 'cui_str': 'Brassica napus'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0177442,"Students exposed to the BITB-HSC demonstrated significant short-term changes in victim empathy and bystander barriers/facilitators, and long-term changes in rape myths, media literacy, bystander readiness, and knowledge relative to youth in the control condition.","[{'ForeName': 'Katie M', 'Initials': 'KM', 'LastName': 'Edwards', 'Affiliation': 'Departments of Psychology and Prevention Innovations Research Center, University of New Hampshire, Durham, NH, USA. katie.edwards@unh.edu.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Banyard', 'Affiliation': 'Rutgers University, School of Social Work, New Brunswick, NJ, USA.'}, {'ForeName': 'Stephanie N', 'Initials': 'SN', 'LastName': 'Sessarego', 'Affiliation': 'Department of Psychology, University of New Hampshire, Durham, NH, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Waterman', 'Affiliation': 'Department of Psychology, University of New Hampshire, Durham, NH, USA.'}, {'ForeName': 'Kimberly J', 'Initials': 'KJ', 'LastName': 'Mitchell', 'Affiliation': 'Departments of Psychology and Crimes against Children Research Center, Durham, NH, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': 'Tufts Medical Center, Institute for Clinical Research and Health Policy Studies, Boston, MA, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-019-01000-w']
148,31676898,Effects of a Community-to-Clinic Navigation Intervention on Colorectal Cancer Screening Among Underserved People.,"BACKGROUND
Colorectal cancer screening remains suboptimal among poor and underserved people.
PURPOSE
We tested the effectiveness of a community-to-clinic navigator intervention to guide multicultural, underinsured individuals into primary care clinics to complete colorectal cancer screening.
METHODS
This two-phase behavioral intervention study was conducted in Phoenix, Arizona (2012-2018). Community sites were randomized to group education or group education plus tailored navigation to increase attendance at primary care clinics (Phase I). Individuals who completed a clinic appointment received the tailored navigation in person or via phone (Phase II).
RESULTS
In Phase I (N = 345), 37.9% of the intervention group scheduled a clinic appointment versus 19.4% of the comparison group. In Phase II, 26.5% of the original intervention group were screened versus only 10.4% of the original comparison group. Those in the intervention group were 3.84 times more likely to be screened than were those in the comparison group (odds ratio = 3.84; 95% confidence interval = 1.81-6.92).
CONCLUSIONS
Translation of an efficacious tailored navigation intervention for colorectal cancer screening to a community-to-clinic context is associated with significantly increased rates of colorectal cancer screening. Navigation assistance to address barriers to screening may serve as the most important component of any educational program to increase individual adherence to colorectal cancer screening.",2020,Community sites were randomized to group education or group education plus tailored navigation to increase attendance at primary care clinics (Phase I).,"['Phoenix, Arizona (2012-2018', 'Colorectal Cancer Screening Among Underserved People']","['Community-to-Clinic Navigation Intervention', 'group education or group education plus tailored navigation to increase attendance at primary care clinics (Phase I', 'tailored navigation in person or via phone (Phase II', 'community-to-clinic navigator intervention']",[],"[{'cui': 'C0003787', 'cui_str': 'Arizona'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0150375', 'cui_str': 'Group instruction'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]",[],,0.0153092,Community sites were randomized to group education or group education plus tailored navigation to increase attendance at primary care clinics (Phase I).,"[{'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Menon', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Szalacha', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kue', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Herman', 'Affiliation': 'Rand Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bucho-Gonzalez', 'Affiliation': 'Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lance', 'Affiliation': 'University of Arizona Cancer Center, Tucson, AZ, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Larkey', 'Affiliation': 'Arizona State University, Phoenix, AZ, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz049']
149,31701153,Very Low Nicotine Content Cigarettes Disrupt the Feedback Loop of Affective States and Smoking Behavior.,"INTRODUCTION
Smoking to reduce negative affect has been identified as a key motivational feature of tobacco use. Our recent work suggests that smoking very low nicotine content (VLNC) cigarettes reduces the relationship between negative affect and smoking behavior over a 6-week period. Here, we sought to extend our findings by evaluating whether a gradual or immediate approach to switching to VLNC cigarettes led to a differential reduction in the relationship between affect and smoking behavior over a longer (20-week) period.
AIMS AND METHODS
Participants (n = 1250) were adult smokers from 10 US sites randomized to one of three groups: gradual nicotine reduction (15.5, 11.7, 5.2, 2.4, and 0.4 mg of nicotine per gram of tobacco [mg/g]), immediate nicotine reduction (0.4 mg/g), or standard nicotine content cigarettes (15.5 mg/g; control), for 20 weeks. We examined whether the relationship between affect-both negative and positive-and cigarettes per day differed as a function of reduction group.
RESULTS
We found that both negative and positive affect were associated with cigarette consumption in the control group, but not in the gradual or immediate reduction groups across the 20 weeks of exposure.
CONCLUSIONS
Our results extend previous findings that switching to VLNC cigarettes disrupts the relationship between affect and cigarette consumption by showing that either gradually or immediately reducing cigarette nicotine content achieves this disruption. These findings provide further evidence that switching to VLNC cigarettes reduces nicotine-related reinforcement of cigarette smoking.
IMPLICATIONS
These findings support the notion that switching to very low nicotine content cigarettes reduces the association between affect and smoking behavior, and that either a gradual or immediate nicotine reduction approach achieves this reduction. This provides further evidence that switching to very low nicotine content cigarettes weakens reinforcement mechanisms associated with nicotine dependence.",2020,"We found that both negative and positive affect were associated with cigarette consumption in the control group but not in the gradual or immediate reduction groups across the 20 weeks of exposure.
",['Participants (n=1250) were adult smokers from ten U.S. sites randomized to one of three groups'],"['nicotine per gram of tobacco [mg/g]), immediate nicotine reduction', 'gradual nicotine reduction', 'standard nicotine content cigarettes']",['cigarette consumption'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0459840', 'cui_str': 'Cigarette consumption (observable entity)'}]",,0.010842,"We found that both negative and positive affect were associated with cigarette consumption in the control group but not in the gradual or immediate reduction groups across the 20 weeks of exposure.
","[{'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Robinson', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kypriotakis', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': ""Al'absi"", 'Affiliation': 'Department of Family Medicine and BioBehavioral Health, University of Minnesota Medical School, Duluth, MN.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Drobes', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Leischow', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ.'}, {'ForeName': 'F Joseph', 'Initials': 'FJ', 'LastName': 'McClernon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Pacek', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Herbert H', 'Initials': 'HH', 'LastName': 'Severson', 'Affiliation': 'Oregon Research Institute, Eugene, OR.'}, {'ForeName': 'Tracy T', 'Initials': 'TT', 'LastName': 'Smith', 'Affiliation': 'Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Joni A', 'Initials': 'JA', 'LastName': 'Jensen', 'Affiliation': 'Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Lori G', 'Initials': 'LG', 'LastName': 'Strayer', 'Affiliation': 'Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Cinciripini', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz209']
150,32078947,"Effect of an upright (vs. stooped) posture on interpretation bias, imagery, and emotions.","BACKGROUND AND OBJECTIVES
Adopting an upright (vs. stooped) posture has been related to positive effects on emotional and cognitive processes. However, there is no evidence concerning the effect of posture on two key processes associated with the maintenance of depression: interpretation bias and vividness of mental imagery. The objectives were to investigate the effect of adopting an upright (vs. stooped) posture on interpretation bias and vividness of positive and negative mental imagery, and to explore the interplay between these processes and depression-related emotions.
METHODS
The sample consisted of 54 participants (M age = 22.00, 64.8% women), who were randomly assigned to the upright or stooped condition. Participants answered self-report measures while they were adopting a specific posture. Posture was monitored through inertial technology.
RESULTS
Main results were that: upright (vs. stooped) posture led to more positive interpretations of ambiguous information and increased positive emotions related to depression (happiness, optimism and vigor); time in an upright position was associated with change in interpretation bias and vividness of positive mental imagery; and level of depressive symptomatology moderated the effect of posture on the change in interpretation bias.
LIMITATIONS
Limitations are related to the use of non-clinical sample, the use of short-term measurements, and the lack of an experimental condition adopting the usual posture.
CONCLUSIONS
Posture interacts with mechanisms involved in the maintenance of depression, as well as with depression-related emotions. This study has clinical implications that should be continued explored in order to clarify the role of manipulating the posture in individuals with depressive symptomatology.",2020,"RESULTS
Main results were that: upright (vs. stooped) posture led to more positive interpretations of ambiguous information and increased positive emotions related to depression (happiness, optimism and vigor); time in an upright position was associated with change in interpretation bias and vividness of positive mental imagery; and level of depressive symptomatology moderated the effect of posture on the change in interpretation bias.
","['individuals with depressive symptomatology', '54 participants (M age \xa0=\xa022.00, 64.8% women']",['upright (vs. stooped) posture'],"['interpretation bias and vividness of positive mental imagery; and level of depressive symptomatology', 'interpretation bias, imagery, and emotions', 'positive emotions related to depression (happiness, optimism and vigor); time']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1262869', 'cui_str': 'Posture'}]","[{'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",54.0,0.0751306,"RESULTS
Main results were that: upright (vs. stooped) posture led to more positive interpretations of ambiguous information and increased positive emotions related to depression (happiness, optimism and vigor); time in an upright position was associated with change in interpretation bias and vividness of positive mental imagery; and level of depressive symptomatology moderated the effect of posture on the change in interpretation bias.
","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Miragall', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, Valencia, Spain; CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN). Instituto Carlos III, Spain. Electronic address: marta.miragall@uv.es.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Borrego', 'Affiliation': 'Neurorehabilitation and Brain Research Group, Instituto de Investigación e Innovación en Bioingeniería. Universitat Politècnica de València, Valencia, Spain. Electronic address: adborgon@i3b.upv.es.'}, {'ForeName': 'Ausiàs', 'Initials': 'A', 'LastName': 'Cebolla', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, Valencia, Spain; CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN). Instituto Carlos III, Spain. Electronic address: ausias.cebolla@uv.es.'}, {'ForeName': 'Ernestina', 'Initials': 'E', 'LastName': 'Etchemendy', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, Valencia, Spain. Electronic address: ernestina.etchemendy@uv.es.'}, {'ForeName': 'Jéssica', 'Initials': 'J', 'LastName': 'Navarro-Siurana', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, Valencia, Spain. Electronic address: jesnasiu@alumni.uv.es.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Llorens', 'Affiliation': 'Neurorehabilitation and Brain Research Group, Instituto de Investigación e Innovación en Bioingeniería. Universitat Politècnica de València, Valencia, Spain; Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales Vithas-NISA. Fundación Hospitales NISA, Valencia, Spain. Electronic address: rllorens@i3b.upv.es.'}, {'ForeName': 'Simon E', 'Initials': 'SE', 'LastName': 'Blackwell', 'Affiliation': 'Department of Psychology, Ruhr-Universität Bochum, Germany; Mental Health Research and Treatment Center, Faculty of Psychology, Ruhr-Universität Bochum, Germany. Electronic address: Simon.Blackwell@ruhr-uni-bochum.de.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, Valencia, Spain; CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN). Instituto Carlos III, Spain. Electronic address: Rosa.Banos@uv.es.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101560']
151,32086006,A personalized approach-avoidance modification intervention to reduce negative body image. A placebo-controlled pilot study.,"BACKGROUND AND OBJECTIVES
Drive for thinness is considered an important factor in the onset and maintenance of negative body image and can be conceptualized as a motivational approach tendency towards thin bodies. The goal of this study was to test whether training thinness-related approach-avoidance tendencies is effective in improving body satisfaction using a personalized training with individuals' own body pictures.
METHODS
Undergraduate women scoring high on drive for thinness (N = 104) were randomly assigned to an experimental, placebo or no training control condition. The experimental training consisted of four training sessions in which participants pushed away thin versions of their own body pictures and pulled closer realistic pictures of themselves. The same stimuli were shown with 50/50 contingency in the placebo training.
RESULTS
The experimental training procedure did not show an effect on self-reported body satisfaction or drive for thinness after one session, four sessions, or one week later. While reaction time indices suggested a marginally significant change in approach-avoidance tendencies in the expected direction, this effect may have been driven by relatively strong thin-approach tendencies in the experimental condition before the start of the training.
LIMITATIONS
High error rates limit the interpretability of the effects on approach-avoidance tendencies. Selection was based on a single item assessing drive for thinness.
CONCLUSIONS
Taken together, our study did not provide evidence that training approach-avoidance tendencies is effective in improving negative body image.",2020,"The experimental training procedure did not show an effect on self-reported body satisfaction or drive for thinness after one session, four sessions, or one week later.",['Undergraduate women scoring high on drive for thinness (N\xa0=\xa0104'],"['placebo', 'training thinness-related approach-avoidance tendencies', 'placebo or no training control condition']",['approach-avoidance tendencies'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0039870', 'cui_str': 'Leanness'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0039870', 'cui_str': 'Leanness'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",104.0,0.0910549,"The experimental training procedure did not show an effect on self-reported body satisfaction or drive for thinness after one session, four sessions, or one week later.","[{'ForeName': 'Klaske A', 'Initials': 'KA', 'LastName': 'Glashouwer', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, the Netherlands; Department of Eating Disorders, Accare Child and Adolescent Psychiatry, Groningen, the Netherlands. Electronic address: k.a.glashouwer@rug.nl.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Timmerman', 'Affiliation': 'Faculty of Behavioural and Social Sciences, DataLab - Research Support, University of Groningen, the Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'de Jong', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101544']
152,32086189,A cluster randomized controlled trial of the SoMe social media literacy body image and wellbeing program for adolescent boys and girls: Study protocol.,"Youth spend substantial time on social media, which can foster self-critical processes that increase risk of body dissatisfaction, disordered eating, and depressed mood. To date, there have been few investigations of interventions to decrease the negative impacts of social media engagement in adolescent boys and girls. This paper outlines the protocol for a cluster randomized controlled trial (RCT) of a four-lesson social media literacy program that was developed based on pilot results and aims to decrease body dissatisfaction, dietary restraint, and strategies to increase muscles. The RCT will be conducted with grades 7-8 students from Australian secondary schools. Using block randomization, grade levels within schools will be assigned to either the SoMe program (intervention) or health lessons as usual (control). Primary outcomes will be body satisfaction, dietary restraint, and strategies to increase muscles. Secondary outcomes will be self-esteem and depressed mood. Participants will complete assessments on four occasions - baseline, five-weeks post-baseline, and six- and 12-month post-baseline. Analyses will compare outcomes in the intervention compared to the control group. This study will be the first to implement a RCT design to evaluate the impact of a school-based social media literacy program designed to mitigate negative impacts of social media.",2020,"This paper outlines the protocol for a cluster randomized controlled trial (RCT) of a four-lesson social media literacy program that was developed based on pilot results and aims to decrease body dissatisfaction, dietary restraint, and strategies to increase muscles.","['grades 7-8 students from Australian secondary schools', 'adolescent boys and girls']","['SoMe program (intervention) or health lessons as usual (control', 'SoMe social media literacy body image and wellbeing program']","['body satisfaction, dietary restraint, and strategies to increase muscles', 'self-esteem and depressed mood']","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}]",,0.0798022,"This paper outlines the protocol for a cluster randomized controlled trial (RCT) of a four-lesson social media literacy program that was developed based on pilot results and aims to decrease body dissatisfaction, dietary restraint, and strategies to increase muscles.","[{'ForeName': 'Chloe S', 'Initials': 'CS', 'LastName': 'Gordon', 'Affiliation': 'La Trobe University, Victoria, Australia. Electronic address: c.gordon@latrobe.edu.au.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Rodgers', 'Affiliation': 'Northeastern University, Boston, MA, USA; Department of Psychiatric Emergency & Acute Care, Lapeyronie Hospital, CHRU, Montpellier, France.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Slater', 'Affiliation': 'Centre for Appearance Research, University of West of England, Bristol, England, United Kingdom.'}, {'ForeName': 'Siân A', 'Initials': 'SA', 'LastName': 'McLean', 'Affiliation': 'La Trobe University, Victoria, Australia; Victoria University, Australia.'}, {'ForeName': 'Hannah K', 'Initials': 'HK', 'LastName': 'Jarman', 'Affiliation': 'La Trobe University, Victoria, Australia.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Paxton', 'Affiliation': 'La Trobe University, Victoria, Australia.'}]",Body image,['10.1016/j.bodyim.2020.02.003']
153,31492912,Effects of anti-H. pylori triple therapy and a probiotic complex on intestinal microbiota in duodenal ulcer.,"This study aimed to investigate the intestinal microbiota in duodenal ulcer (DU) patients, effects of proton pump inhibitors,clarithromycin and amoxicillin, PCA) for Helicobacter pylori (H. pylori) and Bacillus subtilis and Enterococcus faecium (BSEF) on intestinal microbiota. DU patients were randomly assigned to receive either PCA (group TT) or PCA plus BSEF(group TP). The fecal microbiome was conducted using high throughput 16S rDNA gene and internal transcribed spacer sequencings. The diversity and abundance of intestinal bacteria in the DU were significantly lower than health check control (HC) group. In the TT group, the abundance and diversity of both intestinal bacteria and fungi decreased after PCA treatment, compared with those before treatment, whereas in the TP group no obvious changes were observed. In the TT group at all the time points, both the intestinal bacteria and fungi were different from those in the HC group. However, in the TP group, at 10w the bacterial flora abundance was close to that in the HC group. The results indicate that anti- H. pylori treatment induced significant decrease in the diversity of intestinal microbiota, while the combined therapy supplemented with BSEF could protect and restore the intestinal microbiota.",2019,"In the TT group at all the time points, both the intestinal bacteria and fungi were different from those in the HC group.","['duodenal ulcer', 'duodenal ulcer (DU) patients', 'DU patients']","['PCA', 'proton pump inhibitors,clarithromycin and amoxicillin, PCA', 'PCA plus BSEF(group TP', 'anti-H. pylori triple therapy']","['diversity and abundance of intestinal bacteria', 'diversity of intestinal microbiota', 'bacterial flora abundance', 'intestinal microbiota', 'Helicobacter pylori (H. pylori) and Bacillus subtilis and Enterococcus faecium (BSEF) on intestinal microbiota', 'abundance and diversity of both intestinal bacteria']","[{'cui': 'C0013295', 'cui_str': 'Duodenal Ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0004595', 'cui_str': 'Bacillus subtilis'}, {'cui': 'C0085495', 'cui_str': 'Enterococcus faecium'}]",,0.0137975,"In the TT group at all the time points, both the intestinal bacteria and fungi were different from those in the HC group.","[{'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ""Department of Gastroenterology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Zikai', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Sun', 'Affiliation': ""Department of Gastroenterology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': ""Department of Gastroenterology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Zhongsheng', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': ""Department of Gastroenterology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': ""Department of Gastroenterology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': ""Department of Gastroenterology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Yunsheng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Gastroenterology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China. sunny301ddc@126.com.""}]",Scientific reports,['10.1038/s41598-019-49415-3']
154,32073744,Get real: Orbitofrontal cortex mediates the ability to sense reality in early adolescents.,"INTRODUCTION
Orbitofrontal reality filtering (ORFi) is a memory mechanism that distinguishes whether a thought is relevant to present reality or not. In adults, it is mediated by the orbitofrontal cortex (OFC). This region is still not fully developed in preteenagers, but ORFi is already active from age 7. Here, we probe the neural correlates of ORFi in early adolescents, hypothesizing that OFC mediates the sense of reality in this population.
METHODS
Functional magnetic resonance images (fMRI) were acquired in 22 early adolescents during a task composed of two runs: run 1 measuring recognition capacity; run 2 measuring ORFi; each containing two types of images (conditions): distractors (D: images seen for the first time in the current run) and targets (T: images seen for the second time in the current run). Group region of interest (ROI) analysis was performed in a flexible factorial design with two factors (run and condition) using SPM12.
RESULTS
We found significant main effects for the experimental run and condition. The bilateral OFC activation was higher during ORFi than during the first run. Additionally, the OFC was more active while processing distractors than targets.
CONCLUSION
These results confirm, for the first time, the role of OFC in reality filtering in early adolescents.",2020,We found significant main effects for the experimental run and condition.,"['early adolescents', '22 early adolescents during a task composed of two runs']","['run 1 measuring recognition capacity; run 2 measuring ORFi; each containing two types of images (conditions): distractors', 'Orbitofrontal reality filtering (ORFi']",['bilateral OFC activation'],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}]","[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0624791', 'cui_str': 'Ran-2 antigen, rat'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]",22.0,0.0323262,We found significant main effects for the experimental run and condition.,"[{'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Liverani', 'Affiliation': 'Department of Paediatrics, Gynecology and Obstetrics, Division of Development and Growth, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Lorena G A', 'Initials': 'LGA', 'LastName': 'Freitas', 'Affiliation': 'Department of Paediatrics, Gynecology and Obstetrics, Division of Development and Growth, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Siffredi', 'Affiliation': 'Department of Paediatrics, Gynecology and Obstetrics, Division of Development and Growth, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Mikneviciute', 'Affiliation': 'Department of Paediatrics, Gynecology and Obstetrics, Division of Development and Growth, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Martuzzi', 'Affiliation': 'Foundation Campus Biotech Geneva, Geneva, Switzerland.'}, {'ForeName': 'Djalel-Eddine', 'Initials': 'DE', 'LastName': 'Meskaldij', 'Affiliation': 'Department of Paediatrics, Gynecology and Obstetrics, Division of Development and Growth, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Borradori Tolsa', 'Affiliation': 'Department of Paediatrics, Gynecology and Obstetrics, Division of Development and Growth, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Russia', 'Initials': 'R', 'LastName': 'Ha-Vinh Leuchter', 'Affiliation': 'Department of Paediatrics, Gynecology and Obstetrics, Division of Development and Growth, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Schnider', 'Affiliation': 'Department of Clinical Neurosciences, Division of Neurorehabilitation, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Van De Ville', 'Affiliation': 'Institute of Bioengineering, École Polytechnique Fédérale de Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Petra Susan', 'Initials': 'PS', 'LastName': 'Hüppi', 'Affiliation': 'Department of Paediatrics, Gynecology and Obstetrics, Division of Development and Growth, Geneva University Hospitals, Geneva, Switzerland.'}]",Brain and behavior,['10.1002/brb3.1552']
155,32321490,Effects of subgingival air-polishing with trehalose powder on oral biofilm during periodontal maintenance therapy: a randomized-controlled pilot study.,"BACKGROUND
This pilot study was part of a larger study which compared the effect of subgingival air-polishing using trehalose powder with sonic scaling on clinical parameters during supportive periodontal therapy. Within this microbiological part of the investigation subgingival samples were taken from 10 participants to analyze the survival of different bacterial species after the two different treatments as a proof of principle.
METHODS
In 10 participants two non-adjacent, single-root teeth requiring treatment (PD =5 mm with bleeding on probing (BOP) or > 5 mm) were selected following a split-mouth design and were treated either with a sonic scaler or air-polishing device and trehalose powder. For persistent pockets (PD =4 mm and BOP or > 4 mm), treatment was repeated after 3 months. Subgingival biofilm samples were taken at baseline (BL), subsequently and three and six months after treatment. After determination of the bacterial counts (TBL), isolated bacteria were identified by MALDI-TOF-MS. If unsuccessful, PCR and 16S rDNA sequencing were performed.
RESULTS
In both treatment groups, TBL decreased immediately after treatment remaining at a lower level. This confirms the findings of the larger study regarding clinical parameters showing a comparable effect on PD, BOP and CAL. Immediately after treatment, the diversity of detected species decreased significantly more than in the sonic group (p = 0.03). After 3 months, the proportion of Gram-positive anaerobic rods was lower in the air-polishing group (powder/ sonic 7%/ 25.9%, p = 0.025). Also, there was a greater reduction of Gram-negative aerobic rods for this group at this time (air-polishing/ sonic - 0.91 / -0.23 Log10 cfu/ ml, p = 0.020).
CONCLUSION
Within the limitations of this study air-polishing and sonic treatment seem to have a comparable effect on the subgingival oral biofilm during supportive periodontal treatment.
TRIAL REGISTRATION
The study was registered in an international trial register (German Clinical Trial Register number DRKS 00006296) on 10th of June 2015. HTML&TRIAL_ID = DRKS00006296.",2020,"Immediately after treatment, the diversity of detected species decreased significantly more than in the sonic group (p = 0.03).","['periodontal maintenance therapy', '10 participants two non-adjacent, single-root teeth requiring treatment (PD =5\u2009mm with bleeding on probing (BOP) or\u2009>\u20095\u2009mm']","['subgingival air-polishing with trehalose powder', 'sonic scaler or air-polishing device and trehalose powder', 'subgingival air-polishing using trehalose powder with sonic scaling']","['subgingival oral biofilm', 'PD, BOP and CAL', 'proportion of Gram-positive anaerobic rods', 'Subgingival biofilm samples', 'bacterial counts (TBL), isolated bacteria', 'diversity of detected species', 'TBL', 'oral biofilm', 'Gram-negative aerobic rods']","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0439084', 'cui_str': '>5'}]","[{'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0040815', 'cui_str': 'Trehalose'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0684254', 'cui_str': 'Dental scaler'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0035086', 'cui_str': 'Renal osteodystrophy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C2828040', 'cui_str': 'Gram-negative aerobic rod'}]",2.0,0.0632691,"Immediately after treatment, the diversity of detected species decreased significantly more than in the sonic group (p = 0.03).","[{'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Kruse', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, University of Freiburg, Hugstetter Str. 55, 79106, Freiburg, Germany. anne.kruse@uniklinik-freiburg.de.'}, {'ForeName': 'Rabie', 'Initials': 'R', 'LastName': 'Maamar', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, University of Freiburg, Hugstetter Str. 55, 79106, Freiburg, Germany.'}, {'ForeName': 'Dodji L', 'Initials': 'DL', 'LastName': 'Akakpo', 'Affiliation': 'Private Dental Practice Tasler/Steude, Berlin, Germany.'}, {'ForeName': 'Johan P', 'Initials': 'JP', 'LastName': 'Woelber', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, University of Freiburg, Hugstetter Str. 55, 79106, Freiburg, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Wittmer', 'Affiliation': 'Institute of Medical Microbiology and Hospital Hygiene, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Vach', 'Affiliation': 'Department of Medical Biometry and Medical Informatics, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Ratka-Krüger', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, University of Freiburg, Hugstetter Str. 55, 79106, Freiburg, Germany.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al-Ahmad', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, University of Freiburg, Hugstetter Str. 55, 79106, Freiburg, Germany.'}]",BMC oral health,['10.1186/s12903-020-01111-9']
156,32326133,A Metabolically Healthy Profile Is a Transient Stage When Exercise and Diet Are Not Supervised: Long-Term Effects in the EXERDIET-HTA Study.,"Metabolically unhealthy obesity (MUO) is a regular state in people with primary hypertension (HTN), obesity, and who are physically inactive. To achieve and maintain a metabolically healthy overweight/obese (MHO) state should be a main treatment goal. The aims of the study were (1) to determine differences in metabolic profiles of overweight/obese, physically inactive individuals with HTN following a 16-week (POST) supervised aerobic exercise training (SupExT) intervention with an attentional control (AC) group, and (2) to determine whether the changes observed were maintained following six months (6 M) of unsupervised time. Participants (n = 219) were randomly assigned into AC or SupExT groups. All participants underwent a hypocaloric diet. At POST, all participants received diet and physical activity advice for the following 6 M, with no supervision. All measurements were assessed pre-intervention (PRE), POST, and after 6 M. From PRE to POST, MUO participants became MHO with improved ( p < 0.05) total cholesterol (TC, ∆ = -12.1 mg/dL), alanine aminotransferase (∆ = -8.3 U/L), glucose (∆ = -5.5 mg/dL), C-reactive protein (∆ = -1.4 mg/dL), systolic blood pressure (SBP), and cardiorespiratory fitness (CRF) compared to unhealthy optimal cut-off values. However, after 6 M, TC, glucose, and SBP returned to unhealthy values ( p < 0.05). In a non-physically active population with obesity and HTN, a 16-week SupExT and diet intervention significantly improves cardiometabolic profile from MUO to MHO. However, after 6 M of no supervision, participants returned to MUO. The findings of this study highlight the need for regular, systematic, and supervised diet and exercise programs to avoid subsequent declines in cardiometabolic health.",2020,"However, after 6 M, TC, glucose, and SBP returned to unhealthy values ( p < 0.05).","['Participants (n = 219', 'metabolically healthy overweight/obese (MHO) state', 'people with primary hypertension (HTN), obesity, and who are physically inactive', 'overweight/obese, physically inactive individuals with HTN following a 16-week (POST) supervised']","['SupExT and diet intervention', 'Metabolically unhealthy obesity (MUO', 'hypocaloric diet', 'aerobic exercise training (SupExT) intervention with an attentional control (AC']","['systolic blood pressure (SBP), and cardiorespiratory fitness (CRF', 'alanine aminotransferase', 'cardiometabolic profile', 'TC, glucose, and SBP', 'total cholesterol']","[{'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",219.0,0.0262249,"However, after 6 M, TC, glucose, and SBP returned to unhealthy values ( p < 0.05).","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Corres', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Simon M', 'Initials': 'SM', 'LastName': 'Fryer', 'Affiliation': 'School of Sport and Exercise, Oxstalls Campus, University of Gloucestershire, Gloucester GL2 9HW, UK.'}, {'ForeName': 'Aitor Martínez', 'Initials': 'AM', 'LastName': 'Aguirre-Betolaza', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Ilargi', 'Initials': 'I', 'LastName': 'Gorostegi-Anduaga', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Arratibel-Imaz', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Pérez-Asenjo', 'Affiliation': 'Cardiology Unit, Igualatorio Médico Quirúrgico (IMQ-Amárica), 01005 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Francisco-Terreros', 'Affiliation': 'Clinical Trials Unit, Health and Quality of Life Area, TECNALIA, 01009 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Saracho', 'Affiliation': 'Nefrology Department, Osakidetza, Hospital University of Araba, 01009 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Maldonado-Martín', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17082830']
157,32327440,Development and validation of an early pregnancy risk score for the prediction of gestational diabetes mellitus in Chinese pregnant women.,"OBJECTIVE
To develop and validate a set of risk scores for the prediction of gestational diabetes mellitus (GDM) before the 15th gestational week using an established population-based prospective cohort.
METHODS
From October 2010 to August 2012, 19 331 eligible pregnant women were registered in the three-tiered antenatal care network in Tianjin, China, to receive their antenatal care and a two-step GDM screening. The whole dataset was randomly divided into a training dataset (for development of the risk score) and a test dataset (for validation of performance of the risk score). Logistic regression was performed to obtain coefficients of selected predictors for GDM in the training dataset. Calibration was estimated using Hosmer-Lemeshow test, while discrimination was checked using area under the receiver operating characteristic curve (AUC) in the test dataset.
RESULTS
In the training dataset (total=12 887, GDM=979 or 7.6%), two risk scores were developed, one only including predictors collected at the first antenatal care visit for early prediction of GDM, like maternal age, body mass index, height, family history of diabetes, systolic blood pressure, and alanine aminotransferase; and the other also including predictors collected during pregnancy, that is, at the time of GDM screening, like physical activity, sitting time at home, passive smoking, and weight gain, for maximum performance. In the test dataset (total=6444, GDM=506 or 7.9%), the calibrations of both risk scores were acceptable (both p for Hosmer-Lemeshow test >0.25). The AUCs of the first and second risk scores were 0.710 (95% CI: 0.680 to 0.741) and 0.712 (95% CI: 0.682 to 0.743), respectively (p for difference: 0.9273).
CONCLUSION
Both developed risk scores had adequate performance for the prediction of GDM in Chinese pregnant women in Tianjin, China. Further validations are needed to evaluate their performance in other populations and using different methods to identify GDM cases.",2020,"The AUCs of the first and second risk scores were 0.710 (95% CI: 0.680 to 0.741) and 0.712 (95% CI: 0.682 to 0.743), respectively (p for difference: 0.9273).
","['gestational diabetes mellitus (GDM) before the 15th gestational week using an established population-based prospective cohort', 'From October 2010 to August 2012, 19 331 eligible pregnant women were registered in the three-tiered antenatal care network in Tianjin, China, to receive their antenatal care and a two-step GDM screening', 'Chinese pregnant women in Tianjin, China', 'Chinese pregnant women']",[],"['gestational diabetes mellitus', 'time of GDM screening, like physical activity, sitting time at home, passive smoking, and weight gain, for maximum performance', 'AUCs of the first and second risk scores', 'antenatal care visit for early prediction of GDM, like maternal age, body mass index, height, family history of diabetes, systolic blood pressure, and alanine aminotransferase']","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]",[],"[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1313937', 'cui_str': 'Family history of diabetes mellitus'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}]",19331.0,0.0383423,"The AUCs of the first and second risk scores were 0.710 (95% CI: 0.680 to 0.741) and 0.712 (95% CI: 0.682 to 0.743), respectively (p for difference: 0.9273).
","[{'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Leng', 'Affiliation': ""Department of Child Health, Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Child Health, Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Project Office, Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Project Office, Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Child Health, Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': 'Chronic Disease Epidemiology Laboratory, Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Juliana C N', 'Initials': 'JCN', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, Prince of Wales Hospital-International Diabetes Federation Centre of Education, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Population Cancer Research Program and Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China zhuhong@tmu.edu.cn.'}, {'ForeName': 'Xilin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000909']
158,31017639,Efficacy of Integrated Exposure Therapy vs Integrated Coping Skills Therapy for Comorbid Posttraumatic Stress Disorder and Alcohol Use Disorder: A Randomized Clinical Trial.,"Importance
Co-occurrence of posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) is common and associated with psychiatric and functional problems. Understanding whether exposure therapy is tolerable and efficacious for treating PTSD and AUD is critical to ensure that best practice treatments are available.
Objective
To compare the efficacy of integrated (ie, targeting both PTSD and alcohol use) prolonged exposure (I-PE) therapy with present-centered integrated coping skills (I-CS) therapy, a more commonly available treatment, in reducing PTSD symptoms and alcohol use.
Design, Setting, and Participants
This prospective randomized clinical trial with masked assessments considered 186 veterans seeking Veterans Affairs mental health services. A total of 119 veterans with PTSD and AUD were randomized. Data were collected from February 1, 2013, to May 31, 2017, before treatment, after treatment, and at 3- and 6-month follow-ups. Intention-to-treat analyses were performed.
Interventions
Veterans underwent I-PE (Concurrent Treatment of PTSD and Substance Use Disorder Using Prolonged Exposure) or I-CS (Seeking Safety) therapy.
Main Outcomes and Measures
A priori planned outcomes were PTSD symptoms (Clinician Administered PTSD Scale for DSM-5) and percentage of heavy drinking days (Timeline Follow-Back) before treatment, after treatment, and at 3- and 6-month follow-ups.
Results
A total of 119 veterans (mean [SD] age, 41.6 [12.6] years; 107 [89.9%] male) were randomized. Linear mixture models found that PTSD symptoms decreased in both conditions, with a significantly greater decrease for I-PE treatment compared with I-CS treatment (treatment × time interaction, -2.83; F3,233.1 = 4.92; Cohen d = 0.41; P = .002). The percentage of heavy drinking days improved in both conditions but was not statistically different between I-PE and I-CS treatment (treatment × time interaction, 1.8%; F3,209.9 = 0.18; Cohen d = 0.04; P = .91).
Conclusions and Relevance
The I-PE arm had a greater reduction in PTSD symptoms than the I-CS arm and comparable drinking decreases. The study provides evidence that exposure therapy is more efficacious in treating PTSD than a more commonly available integrated treatment without exposure for comorbid PTSD and AUD.
Trial Registration
ClinicalTrials.gov identifier: NCT01601067.",2019,"The percentage of heavy drinking days improved in both conditions but was not statistically different between I-PE and I-CS treatment (treatment × time interaction, 1.8%; F3,209.9 = 0.18; Cohen d = 0.04; P = .91).
","['Comorbid Posttraumatic Stress Disorder and Alcohol Use Disorder', '119 veterans (mean [SD] age, 41.6 [12.6] years; 107 [89.9%] male', '186 veterans seeking Veterans Affairs mental health services', '119 veterans with PTSD and AUD']","['I-PE (Concurrent Treatment of PTSD and Substance Use Disorder Using Prolonged Exposure) or I-CS (Seeking Safety) therapy', 'integrated (ie, targeting both PTSD and alcohol use) prolonged exposure (I-PE) therapy with present-centered integrated coping skills (I-CS) therapy', 'Integrated Exposure Therapy vs Integrated Coping Skills Therapy']","['PTSD symptoms', 'PTSD symptoms (Clinician Administered PTSD Scale for DSM-5) and percentage of heavy drinking days (Timeline Follow-Back', 'percentage of heavy drinking days']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517545', 'cui_str': 'Twelve point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0222045'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]",,0.0309069,"The percentage of heavy drinking days improved in both conditions but was not statistically different between I-PE and I-CS treatment (treatment × time interaction, 1.8%; F3,209.9 = 0.18; Cohen d = 0.04; P = .91).
","[{'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Trim', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Haller', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Brittany C', 'Initials': 'BC', 'LastName': 'Davis', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Ursula S', 'Initials': 'US', 'LastName': 'Myers', 'Affiliation': 'Ralph H. Johnson VA Medical Center, Charleston, South Carolina.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Colvonen', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Blanes', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lyons', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Emma Y', 'Initials': 'EY', 'LastName': 'Siegel', 'Affiliation': 'Department of Psychology, University of Texas, Austin.'}, {'ForeName': 'Abigail C', 'Initials': 'AC', 'LastName': 'Angkaw', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Norman', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, School of Medicine, La Jolla.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Mayes', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.0638']
159,31427654,Whole-body cryotherapy does not augment adaptations to high-intensity interval training.,"The aim of this study was to investigate the effects of regular post-exercise whole-body cryotherapy (WBC) on physiological and performance adaptations to high-intensity interval training (HIT). In a two-group parallel design, twenty-two well-trained males performed four weeks of cycling HIT, with each session immediately followed by 3 min of WBC (-110 °C) or a passive control (CON). To assess the effects of WBC on the adaptive response to HIT, participants performed the following cycling tests before and after the training period; a graded exercise test (GXT), a time-to-exhaustion test (T max ), a 20-km time trial (20 TT ), and a 120-min submaximal test (SM 120 ). Blood samples were taken before and after training to measure changes in basal adrenal hormones (adrenaline, noradrenaline, and cortisol). Sleep patterns were also assessed during training via wrist actigraphy. As compared with CON, the administration of WBC after each training session during four weeks of HIT had no effect on peak oxygen uptake ([Formula: see text]O 2peak ) and peak aerobic power (P peak ) achieved during the GXT, T max duration and work performed (W Tmax ), 20 TT performance, substrate oxidation during the SM 120 , basal adrenaline/noradrenaline/cortisol concentrations, or sleep patterns (P > 0.05). These findings suggest that regular post-exercise WBC is not an effective strategy to augment training-induced aerobic adaptations to four weeks of HIT.",2019,"As compared with CON, the administration of WBC after each training session during four weeks of HIT had no effect on peak oxygen uptake ([Formula: see text]O 2peak ) and peak aerobic power (P peak ) achieved during the GXT, T max duration and work performed (W Tmax ), 20 TT performance, substrate oxidation during the SM 120 , basal adrenaline/noradrenaline/cortisol concentrations, or sleep patterns (P > 0.05).",[],"['passive control (CON', 'graded exercise test (GXT', 'CON', 'WBC', 'regular post-exercise whole-body cryotherapy (WBC']","['peak oxygen uptake ([Formula: see text]O 2peak ) and peak aerobic power (P peak ) achieved during the GXT, T max duration and work performed (W Tmax ), 20 TT performance, substrate oxidation during the SM 120 , basal adrenaline/noradrenaline/cortisol concentrations, or sleep patterns', 'Sleep patterns', 'basal adrenal hormones (adrenaline, noradrenaline, and cortisol']",[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0474396', 'cui_str': 'Sleep pattern finding'}]",22.0,0.0260345,"As compared with CON, the administration of WBC after each training session during four weeks of HIT had no effect on peak oxygen uptake ([Formula: see text]O 2peak ) and peak aerobic power (P peak ) achieved during the GXT, T max duration and work performed (W Tmax ), 20 TT performance, substrate oxidation during the SM 120 , basal adrenaline/noradrenaline/cortisol concentrations, or sleep patterns (P > 0.05).","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Broatch', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, Australia. james.broatch@vu.edu.au.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Poignard', 'Affiliation': 'French Institute of Sport (INSEP), Research Department, Laboratory Sport, Expertise and Performance, Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Hausswirth', 'Affiliation': ""Université Côte d'Azur, LAMHESS, Nice, France.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bishop', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, Australia.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Bieuzen', 'Affiliation': 'Institut National du Sport du Québec, Montréal, Canada.'}]",Scientific reports,['10.1038/s41598-019-48518-1']
160,31427688,"Effects of remote ischemic conditioning on kidney injury in at-risk patients undergoing elective coronary angiography (PREPARE study): a multicenter, randomized clinical trial.","The ability of remote ischemic preconditioning (RIPC) to prevent contrast-induced nephropathy (CIN) following percutaneous coronary angiography in at-risk patients is controversial. No evidence exists regarding potential RIPC positive effects on renal function and clinical outcomes in the long-term. The PREPARE study was a randomized, prospective, multicenter, and double-blinded trial. A total of 222 patients scheduled for coronary angiography and/or percutaneous transluminal coronary angioplasty with an estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73 m 2 , or eGFR between 40 and 60 mL/min/1.73 m 2 and two further risk factors were allocated to RIPC or control groups. Preventive measures were applied to all patients, including continuous intravenous saline infusion, withdrawal of nephrotoxic drugs, and limited volume of contrast medium. The primary endpoint, namely incidence of CIN, was 3.8% in the control group and 5.1% in the RIPC group (p = 0.74). The secondary endpoints, i.e., changes in serum creatinine and eGFR levels from baseline to 48 hours and from baseline to 12 months following contrast medium exposure, did not differ between both groups. The incidences of all major clinical events at 12 months were similar in both groups. In this population at risk of CIN, preventive strategies were associated with low CIN incidence. RIPC impacted neither the CIN incidence nor both the renal function and clinical outcomes at 1-year follow-up.",2019,The ability of remote ischemic preconditioning (RIPC) to prevent contrast-induced nephropathy (CIN) following percutaneous coronary angiography in at-risk patients is controversial.,"['kidney injury in at-risk patients undergoing elective coronary angiography (PREPARE study', '222 patients scheduled for coronary angiography and/or percutaneous transluminal coronary angioplasty with an estimated glomerular filtration rate (eGFR)\u2009<\u200940\u2009mL/min/1.73\u2009m 2 , or eGFR between 40 and 60\u2009mL/min/1.73\u2009m 2 and two further risk factors']","['remote ischemic preconditioning (RIPC', 'RIPC', 'percutaneous coronary angiography', 'remote ischemic conditioning']","['changes in serum creatinine and eGFR levels', 'namely incidence of CIN', 'incidences of all major clinical events', 'renal function and clinical outcomes']","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C2936173', 'cui_str': 'Percutaneous Transluminal Coronary Angioplasty'}, {'cui': 'C3811844'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",222.0,0.185525,The ability of remote ischemic preconditioning (RIPC) to prevent contrast-induced nephropathy (CIN) following percutaneous coronary angiography in at-risk patients is controversial.,"[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Macia', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Ivanes', 'Affiliation': 'Université de Tours, EA 4245 Transplantation Immunité Inflammation & Loire Valley Cardiovascular Collaboration, CHRU de Tours, Service de Cardiologie, Tours, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Angoulvant', 'Affiliation': 'Université de Tours, EA 4245 Transplantation Immunité Inflammation & Loire Valley Cardiovascular Collaboration, CHRU de Tours, Service de Cardiologie, Tours, France.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Mateus', 'Affiliation': 'Centre hospitalier de Laval, Service de Cardiologie, Laval, France.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Belle', 'Affiliation': ""Centre hospitalier d'Annecy, Service de Cardiologie, Annecy, France.""}, {'ForeName': 'Meyer', 'Initials': 'M', 'LastName': 'Elbaz', 'Affiliation': 'Université Toulouse, CHU Toulouse, Service de Cardiologie, Toulouse, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Morel', 'Affiliation': 'Université de Strasbourg, Service de Cardiologie, Strasbourg, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Furber', 'Affiliation': 'Institut MITOVASC, UMR INSERM U1083 and CNRS 6015, Service de Cardiologie, CHU Angers, Université Angers, Angers, France.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Bière', 'Affiliation': 'Institut MITOVASC, UMR INSERM U1083 and CNRS 6015, Service de Cardiologie, CHU Angers, Université Angers, Angers, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Prunier', 'Affiliation': 'Institut MITOVASC, UMR INSERM U1083 and CNRS 6015, Service de Cardiologie, CHU Angers, Université Angers, Angers, France. faprunier@chu-angers.fr.'}]",Scientific reports,['10.1038/s41598-019-47106-7']
161,32295531,The effect of BCM guided dry weight assessment on short-term survival in Chinese hemodialysis patients : Primary results of a randomized trial - BOdy COmposition MOnitor (BOCOMO) study.,"BACKGROUND
Lack of accurate and effective assessment tools of fluid status is one of the major challenges to reach proper dry weight (DW) in chronic hemodialysis (HD) population. The aim of this randomized study was to evaluate the effect of bioimpedance guided DW assessment on long-term outcomes in Chinese HD patients. Eligible patients were randomly assigned (1:1) to two groups in each center, the control group and body composition monitor (BCM) group. In the BCM group, DW has been evaluated by bioimpedance technic every 2 months during follow-up. The primary composite endpoint consisted of death, acute myocardial infarction, cerebral infarction, cerebral hemorrhage, and peripheral vascular disease.
METHODS
A total of 445 patients were recruited from 11 hemodialysis centers from Beijing, Tianjin and Shijiazhuang cities from Jan 1, 2013 to Dec 31, 2014. They were randomized into either BCM group or control group. All patients have been followed up for 1 year or until Dec 31, 2014 or censoring.
RESULTS
At baseline, there were no significant differences between two groups in terms of demographic parameters, dialysis vintage, percentage of vascular access, and comorbid conditions. At the end of the study, 18 (4.04%) patients had died (11 in control group and 7 in BCM group). Kaplan-Meier survival analysis showed no significant difference in survival rates between two groups (log-rank test P = 0.07). However, there was an increasing trend of survival rates in BCM group compared to the control group. In the multivariable Cox analysis, there was a nonsignificant trend toward less primary composite end points in the BCM group in the adjusted analysis, the hazard ratio was impressive (0.487, 95% CI 0.217-1.091, P = 0.08).
CONCLUSION
Bioimpedance technic has been applied to assess fluid status for decades and has been proved to be a promising tool for clinical practice. Although short-term outcomes were not improved in the randomized, controlled trial, the ascending trend in survival has been observed. Further studies are needed to investigate the survival benefit of bioimpedance method in DW assessment in a larger sample with longer follow-up period.
TRIAL REGISTRATION
ClinicalTrials.org, NCT01509937. Registered 13 January 2012.",2020,Kaplan-Meier survival analysis showed no significant difference in survival rates between two groups (log-rank test P = 0.07).,"['Chinese HD patients', 'All patients have been followed up for 1\u2009year or until Dec 31, 2014 or censoring', 'Chinese hemodialysis patients ', '445 patients were recruited from 11 hemodialysis centers from Beijing, Tianjin and Shijiazhuang cities from Jan 1, 2013 to Dec 31, 2014', 'Eligible patients', 'chronic hemodialysis (HD) population']","['bioimpedance guided DW assessment', 'BCM guided dry weight assessment', 'control group and body composition monitor (BCM) group', 'BCM']","['demographic parameters, dialysis vintage, percentage of vascular access, and comorbid conditions', 'survival rates', 'death, acute myocardial infarction, cerebral infarction, cerebral hemorrhage, and peripheral vascular disease', 'hazard ratio']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",445.0,0.115078,Kaplan-Meier survival analysis showed no significant difference in survival rates between two groups (log-rank test P = 0.07).,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Nephrology, Capital Medical University Fuxing Hospital, Beijing, China.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jinsheng', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Nephrology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Nephrotic Blood Purification Center, Tianjin Third Central Hospital, Tianjin, China.'}, {'ForeName': 'Yulan', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Nephrology, Beijing Miyun County Hospital, Beijing, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Nephrology, General Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Nephrology, Beijing Shijitan Hospital, Beijing, China.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Nephrology, Beijing Boai Hospital, China Rehabilitation Research Center, Captain Medical University, Rehabilitation Medical College, Beijing, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'Department of Nephrology, Aviation General Hospital, Beijing, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Nephrology, China Academy of Chinese Medical Sciences Guang'anmen Hospital, Beijing, China.""}, {'ForeName': 'Jinghong', 'Initials': 'J', 'LastName': 'Lei', 'Affiliation': 'Department of Nephrology, Beijing Aerospace General Hospital, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China. zuoli@bjmu.edu.cn.""}]",BMC nephrology,['10.1186/s12882-020-01793-x']
162,31605793,A Randomized Double-Blind Phase II Study of the Seneca Valley Virus (NTX-010) versus Placebo for Patients with Extensive-Stage SCLC (ES SCLC) Who Were Stable or Responding after at Least Four Cycles of Platinum-Based Chemotherapy: North Central Cancer Treatment Group (Alliance) N0923 Study.,"INTRODUCTION
The Seneca Valley virus (NTX-010) is an oncolytic picornavirus with tropism for SCLC. This phase II double-blind, placebo-controlled trial evaluated NTX-010 in patients with extensive-stage (ES) SCLC after completion of first-line chemotherapy.
METHODS
Patients with ES SCLC who did not progress after four or more cycles of platinum-based chemotherapy were randomized 1:1 to a single dose of NTX-010 or placebo within 12 weeks of chemotherapy. The primary end point was progression-free survival (PFS). A prespecified interim analysis for futility was performed after 40 events. Viral clearance and the development of neutralizing antibodies were followed.
RESULTS
From January 15, 2010, to January 10, 2013, a total of 50 patients were randomized and received therapy on study (26 received NTX-010 and 24 received placebo). At the specified interim analysis, the median PFS was 1.7 months (95% confidence interval [CI]: 1.4-3.1 months) for the NTX-010 group versus 1.7 months (95% CI: 1.4-4.3 months) for the placebo group (hazard ratio = 1.03, p = 0.92), and the trial was terminated owing to futility. In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus in those in whom it was not detected after treatment (1.0 month [95% CI: 0.4-1.5 months] versus 1.8 months [95% CI: 1.3-5.5 months, p = 0.008] and 0.9 months [95% CI: 0.4-2.6 months] versus 1.3 months [95% CI: 1.0-5.3 months], respectively [p = 0.04]).
CONCLUSIONS
Patients with ES SCLC did not benefit from NTX-010 treatment after chemotherapy with a platinum doublet. Persistence of NTX-010 in the blood 1 or 2 weeks after treatment was associated with a shorter PFS.",2020,"In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus not detected after treatment (1.0 month (95% CI 0.4-1.5 months) vs 1.8 months (95% CI 1.3-5.5 months; p=0.008); and 0.9 months (95% CI 0.4-2.6 months) vs 1.3 months (95% CI 1.0-5.3 months), p=0.04) respectively.
","['patients with extensive stage (ES) SCLC after completion of first line chemotherapy', 'patients with extensive stage SCLC (ES-SCLC) who were stable or responding after at least 4 cycles of platinum-based chemotherapy: NCCTG (Alliance) N0923 Study', 'ES-SCLC patients who did not progress after ≥4 cycles of platinum-based chemotherapy', 'From January 15, 2010 to January 10, 2013, 50 patients']","['Seneca Valley Virus (NTX-010) vs placebo', 'placebo', 'NTX-010', 'NTX-010 or placebo']","['progression free survival (PFS', 'median PFS', 'Viral clearance and the development of neutralizing antibodies', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C1831871', 'cui_str': 'Senecavirus A'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}]",50.0,0.392168,"In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus not detected after treatment (1.0 month (95% CI 0.4-1.5 months) vs 1.8 months (95% CI 1.3-5.5 months; p=0.008); and 0.9 months (95% CI 0.4-2.6 months) vs 1.3 months (95% CI 1.0-5.3 months), p=0.04) respectively.
","[{'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Schenk', 'Affiliation': 'University of Colorado, Aurora, Colorado.'}, {'ForeName': 'Sumithra J', 'Initials': 'SJ', 'LastName': 'Mandrekar', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Grace K', 'Initials': 'GK', 'LastName': 'Dy', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Marie Christine', 'Initials': 'MC', 'LastName': 'Aubry', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Angelina D', 'Initials': 'AD', 'LastName': 'Tan', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Cancer Center of Kansas, Newton, Kansas.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Sachs', 'Affiliation': 'The Toledo Clinic-Maumee, Maumee, Ohio.'}, {'ForeName': 'Jorge J', 'Initials': 'JJ', 'LastName': 'Nieva', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Bertino', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lee Hann', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Schild', 'Affiliation': 'Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Troy W', 'Initials': 'TW', 'LastName': 'Wadsworth', 'Affiliation': 'Northwest NCORP, Multicare Regional Cancer Center, Tacoma, Washington.'}, {'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Adjei', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Julian R', 'Initials': 'JR', 'LastName': 'Molina', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota. Electronic address: molina.julian@mayo.edu.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.09.083']
163,32035361,"Eccentric, but not concentric blood flow restriction resistance training increases muscle strength in the untrained limb.","OBJECTIVES
Little is known regarding the variables or mechanisms mediating cross-education as a result of resistance training. Therefore, the purpose of the present study was to examine the effects of low-load eccentric-only blood flow restriction (Ecc-BFR) and low-load concentric-only BFR (Con-BFR) on indices of cross-education.
DESIGN
Thirty-six women were randomly assigned to 4-wks of unilateral resistance training with Ecc-BFR (n = 12), Con-BFR (n = 12) or control (no intervention, n = 12) group. Eccentric peak torque, concentric peak torque, maximal voluntary isometric contraction torque, muscle thickness, and muscle activation were assessed from the contralateral, untrained arm.
RESULTS
Muscle strength (collapsed across mode) increased from 0-wk to 2-wks (4.9%) and 4-wks (13.0%) for Ecc-BFR only. There were increases in muscle activation (collapsed across mode and group) regardless of training modality, but there were no changes in muscle size for any of the conditions.
CONCLUSIONS
The findings of the present study indicated that low-load Ecc-BFR increased muscle strength. The increases in muscle strength as a result of Ecc-BFR were not mode-specific. Thus, low-load Ecc-BFR provides a unique alternative to maintain muscle function in an untrained limb that may have application during limb immobilization and rehabilitation practices.",2020,"There were increases in muscle activation (collapsed across mode and group) regardless of training modality, but there were no changes in muscle size for any of the conditions.
",['Thirty-six women'],"['low-load eccentric-only blood flow restriction (Ecc-BFR) and low-load concentric-only BFR (Con-BFR', 'concentric blood flow restriction resistance training', 'unilateral resistance training with Ecc-BFR (n\xa0=\xa012), Con-BFR (n\xa0=\xa012) or control (no intervention, n\xa0=\xa012) group']","['Muscle strength', 'low-load Ecc-BFR increased muscle strength', 'muscle size', 'muscle strength', 'Eccentric peak torque, concentric peak torque, maximal voluntary isometric contraction torque, muscle thickness, and muscle activation', 'muscle activation']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}]",36.0,0.0116183,"There were increases in muscle activation (collapsed across mode and group) regardless of training modality, but there were no changes in muscle size for any of the conditions.
","[{'ForeName': 'Ethan C', 'Initials': 'EC', 'LastName': 'Hill', 'Affiliation': 'School of Kinesiology & Physical Therapy, Division of Kinesiology, University of Central Florida, Orlando, FL, 32816, USA. Electronic address: https://ethan.hill@ucf.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.01.013']
164,32162450,The effect of mindfulness-based stress reduction on maternal anxiety and self-efficacy: A randomized controlled trial.,"OBJECTIVE
The aim of the study was to assess the effect of mindfulness-based stress reduction (MBSR) on anxiety and self-efficacy in coping with childbirth.
MATERIAL AND METHODS
This randomized controlled trial was conducted on 70 pregnant women in Abyek city of Qazvin province in Iran. The convenient sampling method was recruited. Samples were assigned to control and intervention groups using random blocks. In addition to routine care, individuals in the intervention group received 6 MBSR training sessions. The data gathering questionnaire in this study included mindfulness, Pregnancy-Related Anxiety Questionnaire, and self-efficacy in coping with childbirth questionnaire.
RESULTS
There was no statistically significant difference between the demographic characteristics in the control and intervention groups. The results of the analysis of variance (ANOVA) with repeated measures indicated the effect of time on the change in the total score of anxiety in the intervention group (p = .001). There was a significant difference between the two groups (p = .001). Also, the results of ANOVA with repeated measures showed that time had no impact on the score of self-efficacy in delivery coping (p = 0/1) and that there was no significant difference between the two groups in this respect (p = .6).
CONCLUSION
The result of this study showed that mindfulness reduces anxiety of pregnant mothers, and it is suggested that mindfulness programs be educated for healthcare providers and pregnant mothers to reduce maternal anxiety and improve pregnancy outcomes and delivery.",2020,There was no statistically significant difference between the demographic characteristics in the control and intervention groups.,"['70 pregnant women in Abyek city of Qazvin province in Iran', 'pregnant mothers']","['MBSR training sessions', 'mindfulness-based stress reduction', 'mindfulness-based stress reduction (MBSR']","['maternal anxiety and self-efficacy', 'score of self-efficacy in delivery coping', 'maternal anxiety', 'demographic characteristics', 'anxiety and self-efficacy', 'total score of anxiety']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",70.0,0.0521586,There was no statistically significant difference between the demographic characteristics in the control and intervention groups.,"[{'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Zarenejad', 'Affiliation': 'Student Research Committee, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Yazdkhasti', 'Affiliation': 'Social Determinants of Health Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Rahimzadeh', 'Affiliation': 'Social Determinants of Health Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mehdizadeh Tourzani', 'Affiliation': 'Reproductive health Department, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Esmaelzadeh-Saeieh', 'Affiliation': 'Social Determinants of Health Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}]",Brain and behavior,['10.1002/brb3.1561']
165,32329963,"Comparison of the effects of three kinds of glucose-lowering drugs on non-alcoholic fatty liver disease in patients with type 2 diabetes: A randomized, open-label, three-arm, active control study.","AIMS/INTRODUCTION
Non-alcoholic fatty liver disease (NAFLD) is often observed in individuals with type 2 diabetes mellitus, and it is known that the presence of type 2 diabetes mellitus leads to the aggravation of NAFLD. The aim of this study was to compare the possible effects of three kinds of oral hypoglycemic agents on NAFLD in individuals with type 2 diabetes mellitus.
MATERIALS AND METHODS
We carried out a prospective clinical trial (a randomized and open-label study) in patients with type 2 diabetes mellitus and NAFLD. A total of 98 patients were randomly allocated either to the dapagliflozin (n = 32), pioglitazone (n = 33) or glimepiride (n = 33) group, and the patients took these drugs for 28 weeks. The primary end-point was the change of the liver-to-spleen ratio on abdominal computed tomography.
RESULTS
There was no difference in baseline clinical characteristics among the three groups. Dapagliflozin, pioglitazone and glimepiride ameliorated hyperglycemia similarly. Bodyweight and visceral fat area were significantly decreased only in the dapagliflozin group. Serum adiponectin levels were markedly increased in the pioglitazone group compared with the other two groups. Dapagliflozin and pioglitazone, but not glimepiride, significantly increased the liver-to-spleen ratio, and the effects of dapagliflozin and pioglitazone on the liver-to-spleen ratio were comparable.
CONCLUSIONS
The present study showed that the decrease of visceral fat area and the increase of adiponectin level contributed to the improvement of NAFLD in patients with type 2 diabetes mellitus. Furthermore, dapagliflozin and pioglitazone exerted equivalent beneficial effects on NAFLD in patients with type 2 diabetes mellitus, although it seemed that these two drugs had different mechanisms of action.",2020,"Dapagliflozin and pioglitazone, but not glimepiride, significantly increased L/S ratio, and the effects of dapagliflozin and pioglitazone on L/S ratio were comparable.
","['subjects with T2DM', 'subjects with type 2 diabetes mellitus (T2DM', 'subjects with T2DM and NAFLD', '98 subjects', 'cases with type 2 diabetes']","['glimepiride', 'pioglitazone', 'Dapagliflozin and pioglitazone', 'Dapagliflozin, pioglitazone and glimepiride', 'dapagliflozin and pioglitazone', 'oral hypoglycemic agents', 'dapagliflozin', 'glucose-lowering drugs']","['change of liver-to-spleen (L/S) ratio on abdominal computed tomography (CT', 'L/S ratio', 'adiponectin level', 'Body weight and visceral fat area (VFA', 'VFA', 'Serum adiponectin level', 'nonalcoholic fatty liver disease']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]",98.0,0.0181313,"Dapagliflozin and pioglitazone, but not glimepiride, significantly increased L/S ratio, and the effects of dapagliflozin and pioglitazone on L/S ratio were comparable.
","[{'ForeName': 'Tomoe', 'Initials': 'T', 'LastName': 'Kinoshita', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Shimoda', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Nakashima', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Fushimi', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Yurie', 'Initials': 'Y', 'LastName': 'Hirata', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Tanabe', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Fuminori', 'Initials': 'F', 'LastName': 'Tatsumi', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Hirukawa', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Junpei', 'Initials': 'J', 'LastName': 'Sanada', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kohara', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Irie', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Momoyo', 'Initials': 'M', 'LastName': 'Nishioka', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Obata', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Nakanishi', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Tomoatsu', 'Initials': 'T', 'LastName': 'Mune', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kaku', 'Affiliation': 'Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kaneto', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Kurashiki, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13279']
166,31417163,Antibody dynamics in Japanese paediatric patients with influenza A infection treated with neuraminidase inhibitors in a randomised trial.,"Neuraminidase inhibitors (NAIs) complement influenza virus infection management by helping to clear virus, alleviate symptoms, and reduce transmission. In a previous randomised study, we examined the effect of 4 NAIs on virus clearance and influenza symptoms in Japanese paediatric patients. In this second analysis, we examined the effects of NAI treatment on antibody responses and virus clearance, and the relationships between antibody responses and patients' infection histories (previous infection; asymptomatic infection via household members of same virus type/subtype; vaccination), and between infection histories and viral kinetics. Haemagglutination inhibition (HI) antibody responses produced HI titres ≥40 by Day 14 of NAI treatment, in parallel with virus clearance (trend test P = 0.001). Comparing patients with and without influenza infection histories (directly or asymptomatic infection via household members) showed that infection history had a marked positive effect on HI antibody responses in patients vaccinated before the current influenza season (before enrolment). Current virus clearance was significantly faster in patients previously infected with the same virus type/subtype than in those not previously infected, and clearance pattern depended on the NAI. Assessment of anti-influenza effects of antiviral drugs and vaccines should consider virus and antibody dynamics in response to vaccination and natural infection histories.",2019,"Current virus clearance was significantly faster in patients previously infected with the same virus type/subtype than in those not previously infected, and clearance pattern depended on the NAI.","['Japanese paediatric patients', 'patients with and without influenza infection histories (directly or asymptomatic infection via household members', ""patients' infection histories (previous infection; asymptomatic infection via household members of same virus type/subtype; vaccination"", 'Japanese paediatric patients with influenza']","['4 NAIs', 'neuraminidase inhibitors', 'Neuraminidase inhibitors (NAIs', 'NAI treatment']","['HI antibody responses', 'Current virus clearance', 'Haemagglutination inhibition (HI) antibody responses produced HI titres ≥40', 'virus clearance and influenza symptoms', 'antibody responses and virus clearance']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0275522', 'cui_str': 'Subclinical Infections'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0449572', 'cui_str': 'Virus type (attribute)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C1311702', 'cui_str': 'thallium-doped sodium iodide'}, {'cui': 'C0027803', 'cui_str': 'N-Acylneuraminate Glycohydrolases'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0202353,"Current virus clearance was significantly faster in patients previously infected with the same virus type/subtype than in those not previously infected, and clearance pattern depended on the NAI.","[{'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Hirotsu', 'Affiliation': 'Hirotsu Clinic, Kawasaki, Japan. non@hirotsu.ptu.jp.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Saisho', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Hasegawa', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Mitsutaka', 'Initials': 'M', 'LastName': 'Kitano', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Shishido', 'Affiliation': 'Shionogi & Co., Ltd., Osaka, Japan.'}]",Scientific reports,['10.1038/s41598-019-47884-0']
167,31881294,"Clinical response rates, placebo response rates, and significantly associated covariates are dependent on choice of outcome measure in hidradenitis suppurativa: A post hoc analysis of PIONEER 1 and 2 individual patient data.","BACKGROUND
The hidradenitis suppurativa clinical response (HiSCR) is the gold standard primary outcome measure for hidradenitis suppurativa clinical trials; however, it does not assess the presence of draining tunnels, a common finding in advanced disease. It is unclear what the effect of the presence or absence of draining tunnels has on the efficacy of adalimumab therapy in moderate and advanced disease.
OBJECTIVES
We evaluated the efficacy of adalimumab versus placebo using the International Hidradenitis Suppurativa Severity Scoring System (IHS4). Additionally, we assessed the effect of draining tunnels on therapeutic response as measured by both the HiSCR and change in nodule counts.
METHODS
Reanalysis was conducted with the IHS4 and PIONEER 1 and 2 individual patient data. Both binary outcomes (achieving HiSCR and achieving change in IHS4 severity category) and continuous outcomes (nodule counts and IHS4 score) were calculated with R. Regression modeling was undertaken to assess the effect of draining tunnels and other variables. P < .05 was considered statistically significant.
RESULTS
The significance of adalimumab therapy depended on the outcome measure used. Placebo response rates were highest when binary outcome measures were used. Draining tunnels, smoking, antibiotics, and body mass index influenced HiSCR response in PIONEER 2. Significant differences in disease severity were observed between PIONEER 1 and 2 data sets.
CONCLUSIONS
Elevated placebo response rates in PIONEER 1 and 2 are partially attributable to the use of binary outcome measures. Draining tunnels influence clinical response as measured by HiSCR and nodule counts in PIONEER 2. Further investigation into the effect of body mass index on clinical response is required.",2020,We evaluated the efficacy of adalimumab versus placebo using the International Hidradenitis Suppurativa Severity Score System (IHS4).,['Hidradenitis Suppurativa'],['adalimumab versus placebo'],"['Draining tunnels, smoking, antibiotics and BMI influence HiSCR response', 'Placebo response rates', 'Clinical Response Rates, Placebo Response Rates', 'disease severity', 'IHS4 severity category) and continuous outcomes (nodule counts and IHS4 score']","[{'cui': 'C0162836', 'cui_str': 'Acne Inversa'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.120369,We evaluated the efficacy of adalimumab versus placebo using the International Hidradenitis Suppurativa Severity Score System (IHS4).,"[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Frew', 'Affiliation': 'Laboratory of Investigative Dermatology, The Rockefeller University, New York, New York. Electronic address: jfrew@rockefeller.edu.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Jiang', 'Affiliation': 'Department of Biostatistics, The Rockefeller University, New York, New York.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Department of Biostatistics, The Rockefeller University, New York, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Grand', 'Affiliation': 'Laboratory of Investigative Dermatology, The Rockefeller University, New York, New York; Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Navrazhina', 'Affiliation': 'Laboratory of Investigative Dermatology, The Rockefeller University, New York, New York; Weill Cornell/Rockefeller/Sloan Kettering Tri-Institutional MD-PhD Program, Weill Cornell University, New York, New York.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Vaughan', 'Affiliation': 'Department of Biostatistics, The Rockefeller University, New York, New York.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'Laboratory of Investigative Dermatology, The Rockefeller University, New York, New York.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.12.044']
168,31357206,Pharmacological mechanisms of interhemispheric signal propagation: a TMS-EEG study.,"Interhemispheric connections across the corpus callosum have a predominantly inhibitory effect. Previous electrophysiology studies imply that local inhibitory circuits are responsible for inducing transcallosal inhibition, likely through inhibitory GABA B -mediated neurotransmission. We investigated the neurochemical mechanisms involved in interhemispheric connectivity by measuring transcranial magnetic stimulation (TMS)-induced interhemispheric signal propagation (ISP) in the motor cortex and dorsolateral prefrontal cortex (DLPFC) with electroencephalography (EEG) recordings under the pharmacological effects of baclofen, L-DOPA, dextromethorphan, and rivastigmine. We hypothesized that for both stimulated regions, GABA B receptor agonist baclofen would decrease ISP when compared against baseline while drugs that target other neurotransmitter systems (dopaminergic, acetylcholinergic, and glutamatergic systems) would have no effect on ISP. Twelve right-handed healthy volunteers completed this study and underwent TMS across five sessions in a randomized order. In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions. There were no drug-induced changes in ISP in the DLPFC and baseline ISP did not differ across experimental sessions for both brain regions. Together, our results suggest that the inhibitory effects observed with interhemispheric signal transmission are mediated by a population of interneurons involving GABA B receptor neurotransmission. Inhibitory mechanisms of ISP may be more salient for motor-related functions in the motor cortex than for cognitive control in the DLPFC. These findings are a fundamental step in advancing our understanding of interhemispheric connectivity and may be used to identify treatments for disorders in which transcallosal transmission is dysfunctional.",2020,"In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions.",['Twelve right-handed healthy volunteers'],"['baclofen, L-DOPA, dextromethorphan, and rivastigmine', 'TMS', 'transcranial magnetic stimulation (TMS)-induced interhemispheric signal propagation (ISP']","['ISP under baclofen', 'ISP']","[{'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0649350', 'cui_str': 'rivastigmine'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}]",12.0,0.0545946,"In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions.","[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Hui', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Zomorrodi', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Lioumis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Salavati', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0468-7']
169,31641058,Communicating risk differences between electronic and combusted cigarettes: the role of the FDA-mandated addiction warning and a nicotine fact sheet.,"INTRODUCTION
The US Food and Drug Administration requires e-cigarettes to carry a nicotine addiction warning. This research compared the effects of messages communicating comparative risk of electronic and combusted cigarettes (CR messages) with and without the mandated warning and tested the effects of showing a nicotine fact sheet (NFS) before exposure to CR messages with warning.
METHOD
In an online experiment, 1528 US adult smokers were randomised to one of four conditions: (1) three CR messages, (2) three CR messages in condition one with an addiction warning, (3) an NFS followed by the three messages in condition 2 and (4) control messages. Outcomes included message reactions and perceived effectiveness, e-cigarette-related and cigarette-related beliefs and behavioural intentions and nicotine-related beliefs.
RESULTS
CR messages with and without an addiction warning did not differ. The NFS condition produced higher odds of correctly understanding the risk of nicotine and stronger beliefs that switching to e-cigarettes could reduce health risks (response efficacy) than other treatments. Compared with control, all messages made it more likely for people to report e-cigarettes are less harmful than cigarettes and increased response efficacy and switch intentions to e-cigarettes. Only NFS condition increased correct beliefs about the risk of nicotine and self-efficacy about switching to e-cigarettes.
CONCLUSION
Including an addiction warning on CR messages did not reduce intentions to switch to e-cigarettes. Communicating accurate risk of nicotine together with CR messages and addiction warning increased smokers' self-efficacy beliefs about switching completely to e-cigarettes, making it a potentially promising antitobacco communication strategy.",2020,The NFS condition produced higher odds of correctly understanding the risk of nicotine and stronger beliefs that switching to e-cigarettes could reduce health risks (response efficacy) than other treatments.,['1528 US adult smokers'],"['CR messages, (2) three CR messages in condition one with an addiction warning, (3) an NFS followed by the three messages in condition 2 and (4) control messages', 'electronic and combusted cigarettes', 'electronic and combusted cigarettes (CR messages', 'nicotine fact sheet (NFS']","['message reactions and perceived effectiveness, e-cigarette-related and cigarette-related beliefs and behavioural intentions and nicotine-related beliefs', ""smokers' self-efficacy beliefs"", 'health risks (response efficacy', 'correct beliefs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0439643', 'cui_str': 'Sheets (qualifier value)'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",,0.0238373,The NFS condition produced higher odds of correctly understanding the risk of nicotine and stronger beliefs that switching to e-cigarettes could reduce health risks (response efficacy) than other treatments.,"[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Communication, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Popova', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, USA lpopova1@gsu.edu.'}]",Tobacco control,['10.1136/tobaccocontrol-2019-055204']
170,31995812,Evaluating global brain connectivity as an imaging marker for depression: influence of preprocessing strategies and placebo-controlled ketamine treatment.,"Major depressive disorder (MDD) is associated with altered global brain connectivity (GBC), as assessed via resting-state functional magnetic resonance imaging (rsfMRI). Previous studies found that antidepressant treatment with ketamine normalized aberrant GBC changes in the prefrontal and cingulate cortices, warranting further investigations of GBC as a putative imaging marker. These results were obtained via global signal regression (GSR). This study is an independent replication of that analysis using a separate dataset. GBC was analyzed in 28 individuals with MDD and 22 healthy controls (HCs) at baseline, post-placebo, and post-ketamine. To investigate the effects of preprocessing, three distinct pipelines were used: (1) regression of white matter (WM)/cerebrospinal fluid (CSF) signals only (BASE); (2) WM/CSF + GSR (GSR); and (3) WM/CSF + physiological parameter regression (PHYSIO). Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal. Ketamine had no effect compared to baseline or placebo in either group in any pipeline. PHYSIO did not resemble GBC preprocessed with GSR. These results concur with several studies that used GSR to study GBC. Further investigations are warranted into disease-specific components of global fMRI signals that may drive these results and of GBCr as a potential imaging marker in MDD.",2020,"Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal.","['Major depressive disorder (MDD', '28 individuals with MDD and 22 healthy controls (HCs) at baseline, post']","['placebo', 'Ketamine', 'placebo-controlled ketamine', 'ketamine', 'white matter (WM)/cerebrospinal fluid (CSF) signals only (BASE); (2) WM/CSF\u2009+\u2009GSR (GSR); and (3) WM/CSF\u2009+\u2009physiological parameter regression (PHYSIO']","['GBC', 'Reduced GBC']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0682708'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0684321', 'cui_str': 'Regression'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",28.0,0.0521611,"Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. christoph.kraus@nih.gov.'}, {'ForeName': 'Anahit', 'Initials': 'A', 'LastName': 'Mkrtchian', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Evans', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0624-0']
171,31995813,"Modafinil enhances cognitive, but not emotional conflict processing via enhanced inferior frontal gyrus activation and its communication with the dorsomedial prefrontal cortex.","Cognitive control regulates cognitive and emotional systems to facilitate goal-directed behavior in the context of task-irrelevant distractors. Cognitive control deficits contribute to residual functional impairments across psychiatric disorders and represent a promising novel treatment target. Translational evidence suggests that modafinil may enhance performance in executive functions; however, differential effects on regulatory control in cognitive and emotional domains have not been examined. The present pre-registered randomized-controlled pharmacological fMRI trial examined differential effects of modafinil (single-dose, 200 mg) on cognitive and emotional conflict processing. To further separate objective cognitive enhancing effects from subjective performance perception, a metacognitive paradigm was employed. Results indicated that modafinil specifically enhanced cognitive conflict performance and concomitantly increased activation in the inferior frontal gyrus and its functional communication with the dorsomedial prefrontal cortex. Exploratory analysis further revealed modafinil-enhanced basolateral amygdala reactivity to cognitive conflict, with stronger reactivity being associated with higher cognitive conflict performance. Whereas modafinil enhanced cognitive performance in the metacognitive paradigm, confidence indices remained unaffected. Overall, the present results suggest that modafinil has the potential to enhance cognitive conflict processing while leaving emotional conflict processing unaffected. On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information. The pattern of cognitive enhancing effects in the absence of effects on affective processing suggests a promising potential to enhance cognitive control in clinical populations.",2020,"On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information.",[],"['Modafinil', 'modafinil']","['cognitive performance', 'cognitive and emotional conflict processing', 'cognitive conflict performance']",[],"[{'cui': 'C0066677', 'cui_str': 'modafinil'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}]",,0.0288783,"On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information.","[{'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Congcong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xin', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Daumann', 'Affiliation': 'LVR Clinics of Cologne, Cologne, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Daumann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China. ben_becker@gmx.de.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0625-z']
172,32053828,Global connectivity and local excitability changes underlie antidepressant effects of repetitive transcranial magnetic stimulation.,"Repetitive transcranial magnetic stimulation (rTMS) is a commonly- used treatment for major depressive disorder (MDD). However, our understanding of the mechanism by which TMS exerts its antidepressant effect is minimal. Furthermore, we lack brain signals that can be used to predict and track clinical outcome. Such signals would allow for treatment stratification and optimization. Here, we performed a randomized, sham-controlled clinical trial and measured electrophysiological, neuroimaging, and clinical changes before and after rTMS. Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays. To capture the rTMS-driven changes in connectivity and causal excitability, resting fMRI and TMS/EEG were performed before and after the treatment. Baseline causal connectivity differences between depressed patients and healthy controls were also evaluated with concurrent TMS/fMRI. We found that active, but not sham rTMS elicited (1) an increase in dlPFC global connectivity, (2) induction of negative dlPFC-amygdala connectivity, and (3) local and distributed changes in TMS/EEG potentials. Global connectivity changes predicted clinical outcome, while both global connectivity and TMS/EEG changes tracked clinical outcome. In patients but not healthy participants, we observed a perturbed inhibitory effect of the dlPFC on the amygdala. Taken together, rTMS induced lasting connectivity and excitability changes from the site of stimulation, such that after active treatment, the dlPFC appeared better able to engage in top-down control of the amygdala. These measures of network functioning both predicted and tracked clinical outcome, potentially opening the door to treatment optimization.",2020,Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays.,"['Patients (N\u2009=\u200936', 'depressed patients and healthy controls', 'major depressive disorder (MDD']","['Repetitive transcranial magnetic stimulation (rTMS', 'active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC', 'TMS', 'repetitive transcranial magnetic stimulation', 'rTMS']","['connectivity and causal excitability, resting fMRI and TMS/EEG', 'global connectivity and TMS/EEG changes tracked clinical outcome', 'dlPFC global connectivity, (2) induction of negative dlPFC-amygdala connectivity, and (3) local and distributed changes in TMS/EEG potentials']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0450424', 'cui_str': 'To the left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",36.0,0.0327488,Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays.,"[{'ForeName': 'Neir', 'Initials': 'N', 'LastName': 'Eshel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Corey J', 'Initials': 'CJ', 'LastName': 'Keller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Mills-Finnerty', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Huemer', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Psychiatry and Neurosciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carreon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Yee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Shpigel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Neurology, Shenzhen People's Hospital, Shenzhen, China.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McTeague', 'Affiliation': 'Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Maron-Katz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA. amitetkin@stanford.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0633-z']
173,31794974,One-year clinical outcomes following theta burst stimulation for post-traumatic stress disorder.,"Theta burst transcranial magnetic stimulation (TBS) is a potential new treatment for post-traumatic stress disorder (PTSD). We previously reported active intermittent TBS (iTBS) was associated with superior clinical outcomes for up to 1-month, in a sample of fifty veterans with PTSD, using a crossover design. In that study, participants randomized to the active group received a total of 4-weeks of active iTBS, or 2-weeks if randomized to sham. Results were superior with greater exposure to active iTBS, which raised the question of whether observed effects persisted over the longer-term. This study reviewed naturalistic outcomes up to 1-year from study endpoint, to test the hypothesis that greater exposure to active iTBS would be associated with superior outcomes. The primary outcome measure was clinical relapse, defined as any serious adverse event (e.g., suicide, psychiatric hospitalization, etc.,) or need for retreatment with repetitive transcranial magnetic stimulation (rTMS). Forty-six (92%) of the initial study's intent-to-treat participants were included. Mean age was 51.0 ± 12.3 years and seven (15.2%) were female. The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79. Mean days to relapse were 296.0 ± 22.1 in the 4-week group, and 182.0 ± 31.9 in the 2-week group. When used, rTMS retreatment was generally effective. Exploratory neuroimaging revealed default mode network connectivity was predictive of 1-year outcomes (corrected p < 0.05). In summary, greater accumulated exposure to active iTBS demonstrated clinically meaningful improvements in the year following stimulation, and default mode connectivity could be used to predict longer-term outcomes.",2020,"The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79.","['post-traumatic stress disorder (PTSD', 'Mean age was 51.0\u2009±\u200912.3 years and seven (15.2%) were female', 'fifty veterans with PTSD', ""Forty-six (92%) of the initial study's intent-to-treat participants were included""]","['total of 4-weeks of active iTBS', 'active iTBS (4-weeks active iTBS', 'theta burst stimulation', 'active intermittent TBS (iTBS', 'Theta burst transcranial magnetic stimulation (TBS', 'TMS']","['clinical relapse, defined as any serious adverse event (e.g., suicide, psychiatric hospitalization, etc.,) or need for retreatment with repetitive transcranial magnetic stimulation (rTMS', 'Mean days to relapse']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",50.0,0.149203,"The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79.","[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Petrosino', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': ""Mascha van 't"", 'Initials': ""MV'"", 'LastName': 'Wout-Frank', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Aiken', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Swearingen', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Barredo', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Zandvakili', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Noah S', 'Initials': 'NS', 'LastName': 'Philip', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA. noah_philip@brown.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0584-4']
174,32318809,A phase I study of the effect of repeated oral doses of pantoprazole on the pharmacokinetics of a single dose of fedratinib in healthy male subjects.,"PURPOSE
Fedratinib, an oral, selective Janus kinase 2 inhibitor with activity against both wild-type and mutant Janus kinase 2, has pH-dependent solubility, with free solubility at pH 1. Concomitant administration of drugs that reduce gastric acid secretion, such as pantoprazole, may decrease the absorption of fedratinib and affect patient outcomes. The aim of this study was to evaluate the impact of 7-day repeated 40-mg doses of pantoprazole on the pharmacokinetic (PK) properties of a single 500-mg dose of fedratinib in healthy male subjects.
METHODS
In this phase I, single-center, open-label, two-period, two-treatment, fixed-sequence crossover study, healthy male subjects were administered a single dose of fedratinib 500 mg on day 1 in Period 1, followed by pantoprazole 40 mg daily for 7 days (day 1 to day 7) and a single dose of fedratinib 500 mg on day 7 in Period 2. After the discontinuation of nine subjects due to vomiting, the protocol was amended to provide ondansetron as antiemetic prophylaxis to an additional ten enrolled subjects.
RESULTS
Twenty-six subjects were included. Repeated doses of pantoprazole 40 mg resulted in clinically insignificant increases in fedratinib exposure. Maximum plasma concentration increased by 1.09-fold and area under the plasma concentration-time curve from time 0 to infinity increased by 1.15-fold. All treatment-emergent adverse events were mild or moderate, except for one instance of neutropenia, which was considered unrelated to study intervention.
CONCLUSION
Coadministration with pantoprazole did not have clinically meaningful effects on fedratinib PK. No new or unexpected safety signals were observed with fedratinib.",2020,"All treatment-emergent adverse events were mild or moderate, except for one instance of neutropenia, which was considered unrelated to study intervention.
","['healthy male subjects', 'Twenty-six subjects were included']","['pantoprazole', 'ondansetron', 'fedratinib 500\xa0mg on day 1 in Period 1, followed by pantoprazole']","['Maximum plasma concentration', 'gastric acid secretion', 'fedratinib exposure']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0232552', 'cui_str': 'Gastric acid secretion'}, {'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",26.0,0.144717,"All treatment-emergent adverse events were mild or moderate, except for one instance of neutropenia, which was considered unrelated to study intervention.
","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ogasawara', 'Affiliation': 'Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, 07901, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Vince', 'Affiliation': 'Altasciences/Vince and Associates, Overland Park, KS, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, 07901, USA.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Krishna', 'Affiliation': 'Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, 07901, USA. gopal.krishna@bms.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04074-4']
175,32092760,Modulation of the antidepressant effects of ketamine by the mTORC1 inhibitor rapamycin.,"Twenty-four hours after administration, ketamine exerts rapid and robust antidepressant effects that are thought to be mediated by activation of the mechanistic target of rapamycin complex 1 (mTORC1). To test this hypothesis, depressed patients were pretreated with rapamycin, an mTORC1 inhibitor, prior to receiving ketamine. Twenty patients suffering a major depressive episode were randomized to pretreatment with oral rapamycin (6 mg) or placebo 2 h prior to the intravenous administration of ketamine 0.5 mg/kg in a double-blind cross-over design with treatment days separated by at least 2 weeks. Depression severity was assessed using Montgomery-Åsberg Depression Rating Scale (MADRS). Rapamycin pretreatment did not alter the antidepressant effects of ketamine at the 24-h timepoint. Over the subsequent 2-weeks, we found a significant treatment by time interaction (F (8,245) = 2.02, p = 0.04), suggesting a prolongation of the antidepressant effects of ketamine by rapamycin. Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively). In summary, single dose rapamycin pretreatment failed to block the antidepressant effects of ketamine, but it prolonged ketamine's antidepressant effects. This observation raises questions about the role of systemic vs. local blockade of mTORC1 in the antidepressant effects of ketamine, provides preliminary evidence that rapamycin may extend the benefits of ketamine, and thereby potentially sheds light on mechanisms that contribute to depression relapse after ketamine administration.",2020,"Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively).",['Twenty patients suffering a major depressive episode'],"['rapamycin\u2009+\u2009ketamine', 'placebo', 'ketamine', 'Rapamycin', 'rapamycin', 'placebo\u2009+\u2009ketamine', 'rapamycin, an mTORC1 inhibitor, prior to receiving ketamine', 'oral rapamycin']","['remission rates', 'Montgomery-Åsberg Depression Rating Scale (MADRS', 'Depression severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3888046', 'cui_str': 'mTORC1 Complex'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0810233,"Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively).","[{'ForeName': 'Chadi G', 'Initials': 'CG', 'LastName': 'Abdallah', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA. chadi.abdallah@yale.edu.'}, {'ForeName': 'Lynnette A', 'Initials': 'LA', 'LastName': 'Averill', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Selin', 'Initials': 'S', 'LastName': 'Goktas', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Prerana', 'Initials': 'P', 'LastName': 'Purohit', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Ranganathan', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sherif', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Kyung-Heup', 'Initials': 'KH', 'LastName': 'Ahn', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Deepak Cyril', 'Initials': 'DC', 'LastName': ""D'Souza"", 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Formica', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Southwick', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Duman', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0644-9']
176,32315289,Neuroimaging of hypothalamic mechanisms related to glucose metabolism in anorexia nervosa and obesity.,"BACKGROUNDGiven the heightened tolerance to self-starvation in anorexia nervosa (AN), a hypothalamic dysregulation of energy and glucose homeostasis has been hypothesized. Therefore, we investigated whether hypothalamic reactivity to glucose metabolism is impaired in AN.METHODSTwenty-four participants with AN, 28 normal-weight participants, and 24 healthy participants with obesity underwent 2 MRI sessions in a single-blind, randomized, case-controlled crossover study. We used an intragastric infusion of glucose and water to bypass the cephalic phase of food intake. The responsivity of the hypothalamus and the crosstalk of the hypothalamus with reward-related brain regions were investigated using high-resolution MRI.RESULTSNormal-weight control participants displayed the expected glucose-induced deactivation of hypothalamic activation, whereas patients with AN and participants with obesity showed blunted hypothalamic reactivity. Furthermore, patients with AN displayed blunted reactivity in the nucleus accumbens and amygdala. Compared with the normal-weight participants and control participants with obesity, the patients with AN failed to show functional connectivity between the hypothalamus and the reward-related brain regions during water infusion relative to glucose infusion. Finally, the patients with AN displayed typical baseline levels of peripheral appetite hormones during a negative energy balance.CONCLUSIONThese results indicate that blunted hypothalamic glucose reactivity might be related to the pathophysiology of AN. This study provides insights for future research, as it is an extended perspective of the traditional primary nonhomeostatic understanding of the disease.FUNDINGThis study was supported by a grant from the DFG (SI 2087/2-1).",2020,"Compared to normal-weight and obese controls, patients with AN failed to show functional connectivity between the hypothalamus and reward-related brain regions during water relative to glucose.","['Twenty-four participants with AN, 28 normal-weight and 24 healthy participants with obesity underwent 2', 'anorexia nervosa', 'anorexia nervosa and obesity']","['intragastric infusion of glucose and water to bypass the cephalic phase of food intake', 'magnetic resonance imaging (MRI) sessions']","['peripheral appetite hormones', 'glucose-induced deactivation of hypothalamic activation', 'blunted hypothalamic reactivity']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}]","[{'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",24.0,0.0193325,"Compared to normal-weight and obese controls, patients with AN failed to show functional connectivity between the hypothalamus and reward-related brain regions during water relative to glucose.","[{'ForeName': 'Joe J', 'Initials': 'JJ', 'LastName': 'Simon', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Marion A', 'Initials': 'MA', 'LastName': 'Stopyra', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Mönning', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Sailer', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Lavandier', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Lars P', 'Initials': 'LP', 'LastName': 'Kihm', 'Affiliation': 'Endocrinology and Nephrology, Department of Internal Medicine I, and.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'Department of Neuroradiology, University Hospital of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Preissl', 'Affiliation': 'fMEG Center, Helmholtz Center Munich, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Herzog', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Friederich', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, Germany.'}]",The Journal of clinical investigation,['10.1172/JCI136782']
177,32316288,Relative Validity of an Online Herb and Spice Consumption Questionnaire.,"Culinary herbs and spices contribute bioactives to the diet, which act to reduce systemic inflammation and associated disease. Investigating the health effects of herb/spice consumption is hampered, however, by a scarcity of dietary assessment tools designed to collect herb/spice data. The objective of this study was to determine the relative validity of an online 28-item herb/spices intake questionnaire (HSQ). In randomized order, 62 volunteers residing in Idaho, USA, completed the online Diet History Questionnaire III + the HSQ followed one week later by one of two comparative methods: 7-day food records or three telephone-administered 24-h dietary recalls. Relative validity of the HSQ was tested two ways: (1) by comparing herb/spice intakes between the HSQ and comparator, and (2) by determining the correlation between herb/spice data and Healthy Eating Index 2015 score. The HSQ and both comparators identified black pepper, cinnamon and garlic powder as the three most commonly used herbs/spices. The HSQ captured significantly higher measures of the number and amount of herbs/spices consumed than the comparators. The number of herbs/spices consumed was significantly directly correlated with diet quality for the HSQ. These results support the ability of the HSQ to record general herb/spice use, yet suggest that further validation testing is needed.",2020,The HSQ captured significantly higher measures of the number and amount of herbs/spices consumed than the comparators.,"['62 volunteers residing in Idaho, USA, completed the']","['online 28-item herb/spices intake questionnaire (HSQ', 'Online Herb and Spice Consumption Questionnaire', 'online Diet History Questionnaire III + the HSQ followed one week later by one of two comparative methods: 7-day food records or three telephone-administered 24-h dietary recalls']",[],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0020787', 'cui_str': 'Idaho'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0037910', 'cui_str': 'Spice'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453242', 'cui_str': 'Herbs and spices'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",[],62.0,0.0272359,The HSQ captured significantly higher measures of the number and amount of herbs/spices consumed than the comparators.,"[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Blanton', 'Affiliation': 'Department of Nutrition and Dietetics, Idaho State University, Pocatello, ID 83201-8117, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17082757']
178,31229593,Evaluation of a molecular point-of-care testing for viral and atypical pathogens on intravenous antibiotic duration in hospitalized adults with lower respiratory tract infection: a randomized clinical trial.,"OBJECTIVES
The primary objective was to evaluate whether a molecular point-of-care test (POCT) for viral and atypical pathogens added to routine real-time PCR could reduce duration of intravenous antibiotics in hospitalized patients with lower respiratory tract infection (LRTI) compared with routine real-time PCR.
METHODS
In this single-centre, open-label, randomized controlled study, we enrolled hospitalized adults diagnosed with LRTI. Patients were randomized to an intervention group (POCT FilmArray Panel for 20 viruses, atypical pathogens and bacteria plus routine real-time PCR) or a control group (routine real-time PCR for ten pathogens). The primary outcome was duration of intravenous antibiotics during hospitalization. The secondary outcomes included length of stay, cost of hospitalization and de-escalation within 72 hours and between 72 hours and 7 days. Intention-to-treat analysis was used.
RESULTS
Between October 2017 and July 2018, we enrolled 800 eligible patients (398 in the intervention group and 402 in the control group). Duration of intravenous antibiotics in the intervention group was shorter than in the control (7.0 days (interquartile range (IQR) 5.0-9.0) versus 8.0 days (IQR 6.0-11.0); p <0.001). Length of hospital stay in the intervention group was significantly shorter (8.0 days (IQR 7.0-11.0) versus 9.0 days (IQR 7.0-12.0; p <0.001) and the cost of hospitalization in the intervention group was significantly lower ($1804.7 (IQR 1298.4-2633.8) versus $2042.5 (IQR 1427.4-2926.2); p 0.002) than control group. More patients in the intervention group achieved de-escalation within 72 hours (7.9%, 29/367 versus 3.2%, 12/377; p 0.005) and between 72 hours and 7 days (29.7%, 109/367 versus 22.0%, 83/377; p 0.024).
CONCLUSIONS
Use of molecular POCT testing for respiratory viruses and atypical pathogens might help to reduce intravenous antibiotic use in hospitalized LRTI patients.
CLINICAL TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT03391076.",2019,"Length of hospital stay in the intervention group was significantly shorter (8.0 days [IQR, 7.0, 11.0]","['enrolled hospitalized adults diagnosed as LRTIs', 'hospitalized LRTI patients', 'Between October 2017 and July 2018', '800 eligible patients (398 in the intervention group and 402 in the control group', 'hospitalized patients with lower respiratory tract infection (LRTI', 'hospitalized adults with lower respiratory tract infection']","['care test (POCT', 'intervention group (POCT FilmArray Panel for 20 viral and atypical pathogens plus routine real-time PCR) or a control group (routine real-time PCR for 10 pathogens', 'intravenous antibiotic duration']","['duration of intravenous antibiotics during hospitalization', 'de-escalation', 'cost of hospitalization', 'Duration of intravenous antibiotic', 'length of stay, cost of hospitalization and de-escalation', 'Length of hospital stay']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",800.0,0.144005,"Length of hospital stay in the intervention group was significantly shorter (8.0 days [IQR, 7.0, 11.0]","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Shengchen', 'Affiliation': 'Xuanwu Hospital of Capital Medical University, Beijing, China; Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China; Department of Pulmonary and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Department of Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; National Clinical Research Centre of Respiratory Diseases, Beijing, China.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'Department of Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; National Clinical Research Centre of Respiratory Diseases, Beijing, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Department of Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; National Clinical Research Centre of Respiratory Diseases, Beijing, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Beijing Luhe Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Xiong', 'Affiliation': 'Laboratory of Clinical Microbiology and Infectious Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China; Laboratory of Clinical Microbiology and Infectious Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Zhu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; National Clinical Research Centre of Respiratory Diseases, Beijing, China; Laboratory of Clinical Microbiology and Infectious Diseases, China-Japan Friendship Hospital, Beijing, China; Clinical Centre for Pulmonary Infections, Capital Medical University, Beijing, China; Tsinghua University-Peking University Joint Centre for Life Sciences, Beijing, China. Electronic address: caobin_ben@163.com.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2019.06.012']
179,32320100,Randomised controlled trial of a comprehensive protocol for preventing constipation following total hip arthroplasty.,"AIMS AND OBJECTIVES
To evaluate the efficacy and safety of a comprehensive protocol for constipation prevention.
BACKGROUND
Constipation is a common problem for patients undergoing total hip arthroplasty (THA), yet sparse evidence is available to guide constipation prevention after THA.
DESIGN
Randomised controlled superiority clinical trial.
METHODS
This randomised controlled study was carried out according to the Consolidated Standards of Reporting Trials (CONSORT). A total of 80 THA patients were randomised to receive only preoperative education about lifestyle or the combination of education with postoperative abdominal massage and polyethylene glycol 4,000 (Forlax®). Efficacy outcomes included rates of postoperative constipation and enema rescue, as well as time to first postoperative defecation and readmission within 30 days. Safety outcomes were number and type of adverse events.
RESULTS
Patients who received combination treatment showed a significantly lower rate of postoperative constipation during hospitalisation than patients who received only preoperative education (25% versus 55%), and they showed a significantly lower rate of enema rescue (12.5% versus 40%). Many more patients receiving combination treatment experienced their first defecation within two postoperative days than patients who received only preoperative education (62.5% versus 35.9%). In contrast, the two groups were similar in terms of constipation rate on postoperative days 15 and 30, rate of readmission within 30 days and rate of postoperative adverse events.
CONCLUSIONS
These results suggest that our comprehensive protocol can relieve constipation after THA, reduce the need for enema rescue and shorten time to first defecation without sacrificing safety. More work is needed to optimise and develop this protocol further.
RELEVANCE TO CLINICAL PRACTICE
Constipation is a distressing problem that frequently occurs after THA. This study confirmed that a comprehensive protocol including preoperative education, postoperative abdominal massage and polyethylene glycol 4,000 can effectively relieve constipation after THA without sacrificing safety.",2020,"RESULTS
Patients who received combination treatment showed a significantly lower rate of postoperative constipation during hospitalization than patients who received only preoperative education (25% vs 55%), and they showed a significantly lower rate of enema rescue (12.5% vs 40%).","['80 THA patients', 'constipation following total hip arthroplasty', 'patients undergoing total hip arthroplasty (THA']","['preoperative education, postoperative abdominal massage and polyethylene glycol', 'preoperative education about lifestyle, or the combination of education with postoperative abdominal massage and polyethylene glycol 4000 (Forlax®', 'comprehensive protocol']","['rate of readmission within 30 days, and rate of postoperative adverse events', 'rate of postoperative constipation during hospitalization', 'efficacy and safety', 'rate of enema rescue', 'rates of postoperative constipation and enema rescue, as well as time to first postoperative defecation and readmission within 30 days', 'constipation rate', 'number and type of adverse events']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0204956', 'cui_str': 'Preoperative education'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2316341', 'cui_str': 'Massage of abdomen'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0032479', 'cui_str': 'polyethylene glycol 4000'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0948179', 'cui_str': 'Postoperative constipation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014268', 'cui_str': 'Giving patient an enema'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",80.0,0.108095,"RESULTS
Patients who received combination treatment showed a significantly lower rate of postoperative constipation during hospitalization than patients who received only preoperative education (25% vs 55%), and they showed a significantly lower rate of enema rescue (12.5% vs 40%).","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'Department of Orthopedic Surgery, Luoyang Orthopedic Hospital of Henan Province. Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Youwen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedic Surgery, Luoyang Orthopedic Hospital of Henan Province. Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedic Surgery, Luoyang Orthopedic Hospital of Henan Province. Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedics, Tongde Hospital of ZheJiang Province, Hangzhou, China.'}, {'ForeName': 'Hongfeng', 'Initials': 'H', 'LastName': 'Sheng', 'Affiliation': 'Department of Orthopedics, Tongde Hospital of ZheJiang Province, Hangzhou, China.'}]",Journal of clinical nursing,['10.1111/jocn.15299']
180,32316074,The effect of an intervention program on the knowledge and attitudes among medical staff regarding adverse drug reaction reporting.,"PURPOSE
Adverse drug reactions (ADRs) are a growing important public health problem; however, underreporting of ADRs is very common. The aim of the current study was to explore the effect of an intervention program on the knowledge and attitudes among physicians and nurses regarding ADRs reporting.
METHODS
A multicentre study consisted of three phases: filling out a questionnaire; an intervention program; filling out the same questionnaire again. The intervention program consisted of posters, lectures, and distant electronic learning. The questionnaire contained questions about personal/professional demographic variables, and statements regarding knowledge and attitudes regarding ADR reporting.
RESULTS
The data revealed that the intervention program significantly elevated the ""Objective knowledge"" (P < 0.01) and ""Practical knowledge"" (P < 0.02) score as compared to the control group, while no significant differences were found regarding ""Acquired knowledge"" (P = 0.14). Seniority (P = 0.01) and experience in internal medicine (P = 0.05) were demonstrated as significant factors determining the knowledge of the staff. Obligation was the main motive for reporting in 80% of participants. After the intervention, no differences were found in the ""Attitude related to the motive for reporting"" or ""Attitude related to the commitment to report"", between the two groups. However, ""Attitude related to the need to report"" score significantly improved after the intervention (P = 0.04).
CONCLUSIONS
The intervention program increased knowledge and attitudes regarding ADRs reports. Seniority had the most effect on the influence of the intervention program. The data from this study encourages the necessity to hold ongoing intervention programs in order to improve ADRs reporting rate.",2020,"However, ""Attitude related to the need to report"" score significantly improved after the intervention (P = 0.04).
",['physicians and nurses regarding ADRs reporting'],"['intervention program', 'posters, lectures, and distant electronic learning']","['Acquired knowledge', ' score', 'Objective knowledge', 'Attitude related to the motive for reporting"" or ""Attitude', 'knowledge and attitudes regarding ADRs reports', 'Practical knowledge']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.0155771,"However, ""Attitude related to the need to report"" score significantly improved after the intervention (P = 0.04).
","[{'ForeName': 'Miri Potlog', 'Initials': 'MP', 'LastName': 'Shchory', 'Affiliation': 'Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Lee Hilery', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': 'Clinical Pharmacology Unit, Haemek Medical Center, Afula, Affiliated to The Bruce Rapapport School of Medicine, Technion, Haifa, Israel.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Arcavi', 'Affiliation': 'Clinical Pharmacology Unit, Kaplan Medical Center, Hebrew University and Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Shihmanter', 'Affiliation': 'Clinical Pharmacology Unit, Kaplan Medical Center, Hebrew University and Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Matitiahu', 'Initials': 'M', 'LastName': 'Berkovitch', 'Affiliation': 'Clinical Pharmacology Unit, Shamir Medical Center (Assaf Harofeh), Zerifin, Affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Levy', 'Affiliation': 'Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}]",Pharmacoepidemiology and drug safety,['10.1002/pds.5013']
181,32317241,Conventional vs machine learning-based treatment planning in prostate brachytherapy: Results of a Phase I randomized controlled trial.,"PURPOSE
The purpose of this study was to evaluate the noninferiority of Day 30 dosimetry between a machine learning-based treatment planning system for prostate low-dose-rate (LDR) brachytherapy and the conventional, manual planning technique. As a secondary objective, the impact of planning technique on clinical workflow efficiency was also evaluated.
MATERIALS AND METHODS
41 consecutive patients who underwent I-125 LDR monotherapy for low- and intermediate-risk prostate cancer were accrued into this single-institution study between 2017 and 2018. Patients were 1:1 randomized to receive treatment planning using a machine learning-based prostate implant planning algorithm (PIPA system) or conventional, manual technique. Treatment plan modifications by the radiation oncologist were evaluated by computing the Dice coefficient of the prostate V 150% isodose volume between either the PIPA-or conventional-and final approved plans. Additional evaluations between groups evaluated the total planning time and dosimetric outcomes at preimplant and Day 30.
RESULTS
21 and 20 patients were treated using the PIPA and conventional techniques, respectively. No significant differences were observed in preimplant or Day 30 prostate D 90% , V 100% , rectum V 100 , or rectum D 1cc between PIPA and conventional techniques. Although the PIPA group had a larger proportion of patients with plans requiring no modifications (Dice = 1.00), there was no significant difference between the magnitude of modifications between each arm. There was a large significant advantage in mean planning time for the PIPA arm (2.38 ± 0.96 min) compared with the conventional (43.13 ± 58.70 min) technique (p >> 0.05).
CONCLUSIONS
A machine learning-based planning workflow for prostate LDR brachytherapy has the potential to offer significant time savings and operational efficiencies, while producing noninferior postoperative dosimetry to that of expert, conventional treatment planners.",2020,"No significant differences were observed in preimplant or Day 30 prostate D 90% , V 100% , rectum V 100 , or rectum D 1cc between PIPA and conventional techniques.","['for low- and intermediate-risk prostate cancer were accrued into this single-institution study between 2017 and 2018', '41 consecutive patients who underwent']","['Conventional vs machine learning-based treatment planning in prostate brachytherapy', 'machine learning-based prostate implant planning algorithm (PIPA system) or conventional, manual technique', 'machine learning-based treatment planning system for prostate low-dose-rate (LDR) brachytherapy and the conventional, manual planning technique', 'I-125 LDR monotherapy', 'PIPA']","['clinical workflow efficiency', 'mean planning time', 'total planning time and dosimetric outcomes']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0854662', 'cui_str': 'Brachytherapy to prostate'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0032076', 'cui_str': 'Planning Methodology'}, {'cui': 'C0796396', 'cui_str': 'Iodine-125'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",41.0,0.0160555,"No significant differences were observed in preimplant or Day 30 prostate D 90% , V 100% , rectum V 100 , or rectum D 1cc between PIPA and conventional techniques.","[{'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Nicolae', 'Affiliation': 'Department of Medical Physics, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Semple', 'Affiliation': 'Department of Medical Physics, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Department of Radiation Therapy, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'Department of Radiation Therapy, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Department of Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Department of Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Morton', 'Affiliation': 'Department of Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Lucas Castro', 'Initials': 'LC', 'LastName': 'Mendez', 'Affiliation': 'Department of Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Chia-Lin', 'Initials': 'CL', 'LastName': 'Tseng', 'Affiliation': 'Department of Radiation Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Department of Medical Physics, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Ananth', 'Initials': 'A', 'LastName': 'Ravi', 'Affiliation': 'Department of Medical Physics, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada. Electronic address: ananth.ravi@sunnybrook.ca.'}]",Brachytherapy,['10.1016/j.brachy.2020.03.004']
182,32316197,Effectiveness of Motivational Interviewing in Regard to Activities of Daily Living and Motivation for Rehabilitation among Stroke Patients.,"BACKGROUND
Stroke patients urgently need rehabilitation to enhance activities of daily living. This study aims to determine whether motivational interviewing (MI) improves the performance of activities of daily living and enhances motivation for rehabilitation among first-stroke patients.
METHODS
A quasi-experimental design was used in this study. The study recruited 65 patients between March and October 2016. Before the intervention, all patients received routine care. The experimental group (n = 33) received weekly sessions of MI for 6 weeks, whereas the control group (n = 32) received individual attention from a research nurse weekly for 6 weeks. Structured questionnaires were used to collect data, including demographic data, activities of daily living data (Barthel index {BI} and instrumental activities of daily living {IADLs} scale), and rehabilitation motivation data.
RESULTS
The BI and IADLs scores significantly improved with time in both the experimental and control groups. The generalized estimating equation approach showed that at 6 weeks and 3 months after the intervention, the rehabilitation motivation scores in the experimental group were respectively 3.10 and 2.54 points higher than those in the control group, with significant differences.
CONCLUSIONS
MI could effectively enhance motivation for rehabilitation among stroke patients.",2020,The BI and IADLs scores significantly improved with time in both the experimental and control groups.,"['Stroke Patients', 'first-stroke patients', '65 patients between March and October 2016', 'stroke patients']","['Motivational Interviewing', 'individual attention from a research nurse weekly for 6 weeks', 'routine care', 'motivational interviewing (MI']","['demographic data, activities of daily living data (Barthel index {BI} and instrumental activities of daily living {IADLs} scale), and rehabilitation motivation data', 'BI and IADLs scores', 'rehabilitation motivation scores']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0687693', 'cui_str': 'Research nurse'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",65.0,0.0288482,The BI and IADLs scores significantly improved with time in both the experimental and control groups.,"[{'ForeName': 'Hsiao-Mei', 'Initials': 'HM', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Chung Shan Medical University, Taichung 40201, Taiwan.'}, {'ForeName': 'Hsiao-Lu', 'Initials': 'HL', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Yuhing Junior College of Health Care & Management, Kaohsiung 80776, Taiwan.'}, {'ForeName': 'Fu-Chi', 'Initials': 'FC', 'LastName': 'Yang', 'Affiliation': 'College of General Education, National Chin-Yi University of Technology, Taichung 40201, Taiwan.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Chiu', 'Affiliation': 'Department of Nursing, Chung Shan Medical University, Taichung 40201, Taiwan.'}, {'ForeName': 'Shu-Yuan', 'Initials': 'SY', 'LastName': 'Chao', 'Affiliation': 'Department of Nursing, Hungkuang University, Taichung 43302, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17082755']
183,31641203,A secondary analysis of testosterone and electrically evoked resistance training versus testosterone only (TEREX-SCI) on untrained muscles after spinal cord injury: a pilot randomized clinical trial.,"STUDY DESIGN
Secondary analysis of a clinical trial.
OBJECTIVES
To perform a secondary analysis on the effects of neuromuscular electrical stimulation resistance training (RT) combined with testosterone replacement therapy (TRT) compared with TRT on the untrained muscles after spinal cord injury (SCI).
SETTING
Medical research center.
METHODS
Twenty-two men with chronic motor complete SCI were randomized into TRT + RT group (n = 11) or TRT group (n = 11). Both groups received 16 weeks of TRT (2-6 mg/day) via testosterone patches. The TRT + RT group received twice weekly progressive RT of the knee extensor muscles using electrical stimulation and ankle weights. Magnetic resonance images were captured to measure cross-sectional areas (CSAs) of trunk, glutei, and leg muscles.
RESULTS
Total and absolute gluteus maximus m. (14%, P = 0.003 and 16%, P = 0.001), gluteus medius m. (10%; P = 0.008 and 14%; P = 0.02), and total glutei m. (8%, P = 0.01 and 11%, P = 0.005) CSAs increased overtime for the TRT + RT group. Mean between-group differences of 2.86 (95% CI: 0.30, 5.4), 1.89 (95% CI: 0.23, 3.58) and 5.27 (95% CI: 0.90, 9.69) cm 2 were noted for absolute gluteus maximus, total gluteus medius and total glutei CSAs, respectively (P < 0.05). Trunk muscle CSAs showed a trend towards an interaction between groups.
CONCLUSIONS
RT combined with low-dose TRT results in significant hypertrophy compared with TRT only on the adjacent untrained glutei muscles. Trunk muscles may require direct stimulation to evoke hypertrophy. These exploratory findings may be of clinical relevance in the reduction of incidence and severity of pelvic pressure injuries.",2020,"RESULTS
Total and absolute gluteus maximus m. (14%, P = ","['untrained muscles after spinal cord injury (SCI', 'untrained muscles after spinal cord injury', 'Twenty-two men with chronic motor complete SCI']","['testosterone and electrically evoked resistance training versus testosterone only (TEREX-SCI', 'testosterone patches', 'TRT\u2009+\u2009RT', 'TRT', 'neuromuscular electrical stimulation resistance training (RT) combined with testosterone replacement therapy (TRT', 'CSAs']","['total glutei m', 'absolute gluteus maximus, total gluteus medius and total glutei CSAs']","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",22.0,0.145549,"RESULTS
Total and absolute gluteus maximus m. (14%, P = ","[{'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Gorgey', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA. ashraf.gorgey@va.gov.'}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Abilmona', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sima', 'Affiliation': 'Department of Biostatistics, School of Medicine Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Refka E', 'Initials': 'RE', 'LastName': 'Khalil', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Rehan', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': 'Radiology Service, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Adler', 'Affiliation': 'Endocrinology Section Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}]",Spinal cord,['10.1038/s41393-019-0364-3']
184,32317591,Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019.,"OBJECTIVES
Severe cases of coronavirus disease 2019 develop the acute respiratory distress syndrome, requiring admission to the ICU. This study aimed to describe specific pathophysiological characteristics of acute respiratory distress syndrome from coronavirus disease 2019.
DESIGN
Prospective crossover physiologic study.
SETTING
ICU of a university-affiliated hospital from northern Italy dedicated to care of patients with confirmed diagnosis of coronavirus disease 2019.
PATIENTS
Ten intubated patients with acute respiratory distress syndrome and confirmed diagnosis of coronavirus disease 2019.
INTERVENTIONS
We performed a two-step positive end-expiratory pressure trial with change of 10 cm H2O in random order.
MEASUREMENTS AND MAIN RESULTS
At each positive end-expiratory pressure level, we assessed arterial blood gases, respiratory mechanics, ventilation inhomogeneity, and potential for lung recruitment by electrical impedance tomography. Potential for lung recruitment was assessed by the recently described recruitment to inflation ratio. In a subgroup of seven paralyzed patients, we also measured ventilation-perfusion mismatch at lower positive end-expiratory pressure by electrical impedance tomography. At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure. Oxygenation and ventilation inhomogeneity improved but arterial CO2 increased despite unchanged respiratory rate and tidal volume. The recruitment to inflation ratio presented median value higher than previously reported in acute respiratory distress syndrome patients but with large variability (median, 0.79 [0.53-1.08]; range, 0.16-1.40). The FIO2 needed to obtain viable oxygenation at lower positive end-expiratory pressure was significantly correlated with the recruitment to inflation ratio (r = 0.603; p = 0.05). The ventilation-perfusion mismatch was elevated (median, 34% [32-45%] of lung units) and, in six out of seven patients, ventilated nonperfused units represented a much larger proportion than perfused nonventilated ones.
CONCLUSIONS
In patients with acute respiratory distress syndrome from coronavirus disease 2019, potential for lung recruitment presents large variability, while elevated dead space fraction may be a specific pathophysiological trait. These findings may guide selection of personalized mechanical ventilation settings.",2020,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","['Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019', 'patients with acute respiratory distress syndrome', 'acute respiratory distress syndrome from coronavirus disease 2019', 'ICU of a university-affiliated hospital from northern Italy dedicated to care of patients with confirmed diagnosis of coronavirus disease 2019', 'Ten intubated patients with acute respiratory distress syndrome and confirmed diagnosis of coronavirus disease 2019', 'Severe cases of coronavirus disease 2019 develop the acute respiratory distress syndrome, requiring admission to the ICU']",['Lung Recruitment and Ventilation-Perfusion Mismatch'],"['arterial blood gases, respiratory mechanics, ventilation inhomogeneity, and potential for lung recruitment by electrical impedance tomography', 'respiratory rate and tidal volume', 'ventilation-perfusion mismatch']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]",10.0,0.127794,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","[{'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Mauri', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Spinelli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Scotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Colussi', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Basile', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Crotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tubiolo', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Tagliabue', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zanella', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",Critical care medicine,['10.1097/CCM.0000000000004386']
185,32312333,"Effect of garlic powder supplementation on hepatic steatosis, liver enzymes and lipid profile in patients with non-alcoholic fatty liver disease: a double-blind randomised controlled clinical trial.","Non-alcoholic fatty liver disease (NAFLD) includes a range of disorders from simple steatosis to non-alcoholic steatohepatitis. There is no proven drug treatment for NAFLD, and diet modification is considered part of the main line of treatment for this disease. The aim of this study was to investigate the efficacy of garlic supplementation in NAFLD patients. The effect of garlic powder supplementation on hepatic steatosis, liver enzymes and lipid profile was investigated in NAFLD patients. Ninety NAFLD patients were randomly assigned to take either a garlic powder supplement or a placebo for 12 weeks. The treatment group received four tablets of garlic daily (each tablet contained 400 mg garlic powder). The control group received four tablets of placebo (each placebo contained 400 mg starch). At the end of the study, hepatic steatosis was significantly reduced in the treatment group compared with the control group (P = 0·001). In addition, a significant decrease was seen in the serum concentration of alanine transaminase (P < 0·001), aspartate transaminase (P = 0·002), γ-glutamyltransferase (P = 0·003) as well as total cholesterol (P = 0·009), TAG (P < 0·001), HDL-cholesterol (P < 0·001) and LDL-cholesterol (P = 0·01) in the treatment group compared with the control group. No significant difference was seen between the two groups in serum concentration of alkaline phosphatase. Overall, garlic powder supplementation improved hepatic features and lipid profile among NAFLD patients.",2020,No significant difference was seen between the two groups in serum concentration of alkaline phosphatase.,"['NAFLD patients', 'Ninety NAFLD patients', 'patients with non-alcoholic fatty liver disease']","['garlic powder supplement or a placebo', 'garlic daily (each tablet contained 400 mg garlic powder', 'placebo (each placebo contained 400 mg starch', 'garlic powder supplementation', 'garlic supplementation']","['gamma-glutamyltransferase', 'total cholesterol', 'serum concentration of alkaline phosphatase', 'hepatic steatosis', 'high-density lipoprotein-cholesterol', 'hepatic features and lipid profile', 'serum concentration of alanine transaminase', 'triglyceride', 'low-density lipoprotein-cholesterol', 'aspartate transaminase', 'hepatic steatosis, liver enzymes, and lipid profile']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C1119842', 'cui_str': 'GARLIC POWDER'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0331590', 'cui_str': 'Allium ameloprasum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}]",,0.54422,No significant difference was seen between the two groups in serum concentration of alkaline phosphatase.,"[{'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Sangouni', 'Affiliation': 'Student Research Committee, Department of Nutrition, Urmia University of Medical Sciences, PO Box 5756115111, West Azarbaijan Province, Urmia, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohammad Hosseini Azar', 'Affiliation': 'Gastroenterology and Hepatology Subdivision of Internal Medicine Department, Imam Khomeini Hospital, School of Medicine, Urmia University of Medical Sciences, PO Box 5756115111, West Azarbaijan Province, Urmia, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alizadeh', 'Affiliation': 'Food and Beverages Safety Research Center, Department of Nutrition, School of Medicine, Urmia University of Medical Sciences, PO Box 5756115111, West Azarbaijan Province, Urmia, Iran.'}]",The British journal of nutrition,['10.1017/S0007114520001403']
186,32312713,Randomized Phase IIB Trial of the Lignan Secoisolariciresinol Diglucoside in Premenopausal Women at Increased Risk for Development of Breast Cancer.,"We conducted a multiinstitutional, placebo-controlled phase IIB trial of the lignan secoisolariciresinol diglucoside (SDG) found in flaxseed. Benign breast tissue was acquired by random periareolar fine needle aspiration (RPFNA) from premenopausal women at increased risk for breast cancer. Those with hyperplasia and ≥2% Ki-67 positive cells were eligible for randomization 2:1 to 50 mg SDG/day (Brevail) versus placebo for 12 months with repeat bio-specimen acquisition. The primary endpoint was difference in change in Ki-67 between randomization groups. A total of 180 women were randomized, with 152 ultimately evaluable for the primary endpoint. Median baseline Ki-67 was 4.1% with no difference between arms. Median Ki-67 change was -1.8% in the SDG arm ( P = 0.001) and -1.2% for placebo ( P = 0.034); with no significant difference between arms. As menstrual cycle phase affects proliferation, secondary analysis was performed for 117 women who by progesterone levels were in the same phase of the menstrual cycle at baseline and off-study tissue sampling. The significant Ki-67 decrease persisted for SDG (median = -2.2%; P = 0.002) but not placebo (median = -1.0%). qRT-PCR was performed on 77 pairs of tissue specimens. Twenty-two had significant ERα gene expression changes (<0.5 or >2.0) with 7 of 10 increases in placebo and 10 of 12 decreases for SDG ( P = 0.028), and a difference between arms ( P = 0.017). Adverse event incidence was similar in both groups, with no evidence that 50 mg/day SDG is harmful. Although the proliferation biomarker analysis showed no difference between the treatment group and the placebo, the trial demonstrated use of SDG is tolerable and safe.",2020,Median Ki-67 change was -1.8% in the SDG arm (P=0.001) and -1.2% for placebo (P=0.034); with no significant difference between arms.,"['Pre-menopausal Women at Increased Risk for Development of Breast Cancer', '117 women who by progesterone levels', '180 women were randomized, with 152 ultimately evaluable for the primary endpoint', 'Those with hyperplasia and ≥2% Ki-67 positive cells']","['SDG', 'RT-qPCR', 'Lignan Secoisolariciresinol Diglucoside', 'random periareolar fine needle aspiration (RPFNA', 'lignan secoisolariciresinol diglucoside (SDG', 'placebo']","['SDG', 'change in Ki-67', 'Adverse event incidence', 'ERα gene expression changes', 'Median Ki-67 change', 'Median baseline Ki-67']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}]","[{'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0064971', 'cui_str': 'Lignans'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",180.0,0.408017,Median Ki-67 change was -1.8% in the SDG arm (P=0.001) and -1.2% for placebo (P=0.034); with no significant difference between arms.,"[{'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Fabian', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Seema A', 'Initials': 'SA', 'LastName': 'Khan', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Judy E', 'Initials': 'JE', 'LastName': 'Garber', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Dooley', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Yee', 'Affiliation': 'Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Klemp', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Nydegger', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Kandy R', 'Initials': 'KR', 'LastName': 'Powers', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Kreutzjans', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Carola M', 'Initials': 'CM', 'LastName': 'Zalles', 'Affiliation': 'Department of Pathology, Boca Raton Hospital, Boca Raton, Florida.'}, {'ForeName': 'Trina', 'Initials': 'T', 'LastName': 'Metheny', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Phillips', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jinxiang', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Devin C', 'Initials': 'DC', 'LastName': 'Koestler', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Prabhakar', 'Initials': 'P', 'LastName': 'Chalise', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Nanda Kumar', 'Initials': 'NK', 'LastName': 'Yellapu', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Jernigan', 'Affiliation': 'University of Kansas Cancer Center, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Petroff', 'Affiliation': 'Veterinary Diagnostic Laboratory, Michigan State University, Lansing, Michigan.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Hursting', 'Affiliation': 'Department of Nutrition, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Kimler', 'Affiliation': 'Department of Radiation Oncology, University of Kansas Medical Center, Kansas City, Kansas. bkimler@kumc.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0050']
187,32311845,Changes in respiratory mechanics at birth in preterm infants: A pilot study.,"OBJECTIVE
We aimed to measure lung mechanics at birth by the forced oscillation technique (FOT) for assessment of the initial degree of lung aeration and the short-term aeration changes after applying different respiratory support strategies.
METHODS
Eighteen preterm infants (gestational age = 29-36 week) were randomized to receive either continuous positive airway pressure (CPAP) at 5 cmH 2 O only or combined with a sustained inflation (SI; 15 seconds at 25 cmH 2 O after 5 seconds of CPAP) at birth. We assessed the respiratory system reactance at 5 Hz (X 5; increases with lung volume recruitment at a given distending pressure) at 2, 40, and 150 seconds after initiation of CPAP. k-Means clustering of the initial X 5 value (X 5,i ) stratified newborn into either infants with lower (lowerX 5,i ; X 5 < -280 cmH 2 O*s/L) and higher (higherX 5,i ; X 5 > -240 cmH 2 O*s/L) initial degree of lung volume recruitment.
RESULTS
Initial values were highly heterogeneous. In the LowerX 5,i group, X 5 increased with time, with SI-patients showing significantly higher values at 150 seconds than the non-SI group (X 5 = -89 ± 27 cmH 2 O vs -274 ± 58 cmH 2 O). In the higherX 5,i group, X 5 did not improve with time, regardless of the respiratory strategy, suggesting a lack of lung recruitment. Moreover, 75% of infants receiving SI in the higherX 5,i group experienced a transient loss of aeration after the maneuver.
CONCLUSIONS
Preterm newborns present initially with highly heterogeneous lung aeration at birth that significantly impacts the effectiveness of the subsequent lung volume recruitment strategy. FOT may represent a valuable tool for individualizing a respiratory resuscitation at birth as it is noninvasive and may be applied simultaneously to respiratory support.",2020,"In the higherX 5,i group, X 5 did not improve with time, regardless of the respiratory strategy, suggesting a lack of lung recruitment.","['Eighteen preterm infants (gestational age\u2009=\u200929-36 week', 'preterm infants']","['continuous positive airway pressure (CPAP) at 5\u2009cmH 2 O only or combined with a sustained inflation (SI; 15\u2009seconds at 25\u2009cmH 2 O after 5\u2009seconds of CPAP', 'FOT', 'forced oscillation technique (FOT']","['respiratory system reactance', 'transient loss of aeration']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0040704', 'cui_str': 'Transients'}]",18.0,0.0588961,"In the higherX 5,i group, X 5 did not improve with time, regardless of the respiratory strategy, suggesting a lack of lung recruitment.","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Veneroni', 'Affiliation': 'TechRes lab, Department of Electronics, Information and bioengineering, Politecnico di Milano University, Milano, Italy.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Mercadante', 'Affiliation': ""Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca'Granda Foundation, Ospedale Maggiore Policlinico Hospital-Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lavizzari', 'Affiliation': ""Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca'Granda Foundation, Ospedale Maggiore Policlinico Hospital-Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Mariarosa', 'Initials': 'M', 'LastName': 'Colnaghi', 'Affiliation': ""Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca'Granda Foundation, Ospedale Maggiore Policlinico Hospital-Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': ""Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca'Granda Foundation, Ospedale Maggiore Policlinico Hospital-Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Raffaele L', 'Initials': 'RL', 'LastName': 'Dellacà', 'Affiliation': 'TechRes lab, Department of Electronics, Information and bioengineering, Politecnico di Milano University, Milano, Italy.'}]",Pediatric pulmonology,['10.1002/ppul.24772']
188,32312357,Does the unified protocol really change neuroticism? Results from a randomized trial.,"BACKGROUND
Neuroticism is associated with the onset and maintenance of a number of mental health conditions, as well as a number of deleterious outcomes (e.g. physical health problems, higher divorce rates, lost productivity, and increased treatment seeking); thus, the consideration of whether this trait can be addressed in treatment is warranted. To date, outcome research has yielded mixed results regarding neuroticism's responsiveness to treatment, perhaps due to the fact that study interventions are typically designed to target disorder symptoms rather than neuroticism itself. The purpose of the current study was to explore whether a course of treatment with the unified protocol (UP), a transdiagnostic intervention that was explicitly developed to target neuroticism, results in greater reductions in neuroticism compared to gold-standard, symptom focused cognitive behavioral therapy (CBT) protocols and a waitlist (WL) control condition.
METHOD
Patients with principal anxiety disorders (N = 223) were included in this study. They completed a validated self-report measure of neuroticism, as well as clinician-rated measures of psychological symptoms.
RESULTS
At week 16, participants in the UP condition exhibited significantly lower levels of neuroticism than participants in the symptom-focused CBT (t(218) = -2.17, p = 0.03, d = -0.32) and WL conditions(t(207) = -2.33, p = 0.02, d = -0.43), and these group differences remained after controlling for simultaneous fluctuations in depression and anxiety symptoms.
CONCLUSIONS
Treatment effects on neuroticism may be most robust when this trait is explicitly targeted.",2020,"At week 16, participants in the UP condition exhibited significantly lower levels of neuroticism than participants in the symptom-focused CBT (t(218) =",['Patients with principal anxiety disorders (N = 223'],['cognitive behavioral therapy (CBT) protocols and a waitlist (WL) control condition'],"['depression and anxiety symptoms', 'levels of neuroticism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0564509', 'cui_str': 'Level of neuroticism'}]",223.0,0.0475881,"At week 16, participants in the UP condition exhibited significantly lower levels of neuroticism than participants in the symptom-focused CBT (t(218) =","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Sauer-Zavala', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY40506, USA.'}, {'ForeName': 'Jay C', 'Initials': 'JC', 'LastName': 'Fournier', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Jarvi Steele', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Brittany K', 'Initials': 'BK', 'LastName': 'Woods', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Mengxing', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}]",Psychological medicine,['10.1017/S0033291720000975']
189,32033922,Preliminary Report on the Effects of a Low Dose of LSD on Resting-State Amygdala Functional Connectivity.,"BACKGROUND
The practice of ""microdosing,"" or the use of repeated, very low doses of lysergic acid diethylamide (LSD) to improve mood or cognition, has received considerable public attention, but empirical studies are lacking. Controlled studies are needed to investigate both the therapeutic potential and the neurobiological underpinnings of this pharmacologic treatment.
METHODS
The present study was designed to examine the effects of a single low dose of LSD (13 μg) versus placebo on resting-state functional connectivity and cerebral blood flow in healthy young adults. Twenty men and women, 18 to 35 years old, participated in 2 functional magnetic resonance imaging scanning sessions in which they received placebo or LSD under double-blind conditions. During each session, the participants completed drug effect and mood questionnaires, and physiological measures were recorded. During expected peak drug effect, they underwent resting-state blood oxygen level-dependent and arterial spin labeling scans. Cerebral blood flow as well as amygdala and thalamic connectivity were analyzed.
RESULTS
LSD increased amygdala seed-based connectivity with the right angular gyrus, right middle frontal gyrus, and the cerebellum, and decreased amygdala connectivity with the left and right postcentral gyrus and the superior temporal gyrus. This low dose of LSD had weak and variable effects on mood, but its effects on positive mood were positively correlated with the increase in amygdala-middle frontal gyrus connectivity strength.
CONCLUSIONS
These preliminary findings show that a very low dose of LSD, which produces negligible subjective changes, alters brain connectivity in limbic circuits. Additional studies, especially with repeated dosing, will reveal whether these neural changes are related to the drug's purported antidepressant effect.",2020,"RESULTS
LSD increased amygdala seed-based connectivity with the right angular gyrus, right middle frontal gyrus, and the cerebellum, and decreased amygdala connectivity with the left and right postcentral gyrus and the superior temporal gyrus.","['Twenty men and women, 18 to 35 years old, participated in 2 functional magnetic resonance imaging scanning sessions in which they received', 'healthy young adults']","['placebo or LSD', 'lysergic acid diethylamide (LSD', 'LSD (13 μg) versus placebo', 'LSD']","['Resting-State Amygdala Functional Connectivity', 'Cerebral blood flow', 'amygdala-middle frontal gyrus connectivity strength', 'resting-state functional connectivity and cerebral blood flow']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024334', 'cui_str': 'LSD'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0152297', 'cui_str': 'Middle frontal gyrus'}]",20.0,0.116938,"RESULTS
LSD increased amygdala seed-based connectivity with the right angular gyrus, right middle frontal gyrus, and the cerebellum, and decreased amygdala connectivity with the left and right postcentral gyrus and the superior temporal gyrus.","[{'ForeName': 'Anya K', 'Initials': 'AK', 'LastName': 'Bershad', 'Affiliation': 'Department of Psychiatry, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Katrin H', 'Initials': 'KH', 'LastName': 'Preller', 'Affiliation': 'Pharmaco-Neuroimaging and Cognitive-Emotional Processing, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital for Psychiatry Zurich, Zurich, Switzerland.'}, {'ForeName': 'Royce', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Keedy', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Wren-Jarvis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Bremmer', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois. Electronic address: hdew@uchicago.edu.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2019.12.007']
190,31421635,Maintenance of antidepressant and antisuicidal effects by D-cycloserine among patients with treatment-resistant depression who responded to low-dose ketamine infusion: a double-blind randomized placebo-control study.,"Increasing evidence supports a rapid antidepressant and antisuicidal effect of a single subanesthetic dose of ketamine infusion for treatment-resistant depression (TRD). Maintaining the initial clinical response after ketamine infusion in TRD is a crucial next-step challenge. D-cycloserine (DCS), a partial agonist of the glycine co-agonist of the N-methyl-D-aspartate (NMDA) glutamate receptor, is potentially effective as a depression augmentation treatment. However, whether DCS maintains the antidepressant and antisuicidal effects of ketamine infusion remains unknown. In all, 32 patients with TRD (17 with major depression and 15 with bipolar depression) who responded to ketamine infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47 ± 4.11 at baseline were randomly divided to 6-week DCS treatment (250 mg for 2 days, 500 mg for 2 days, 750 mg for 3 days, and 1000 mg for 5 weeks) and placebo groups. Depression symptoms were rated at timepoints of dose titration and weekly. During the 6-week treatment, the total scores of HAMD did not differ between the DCS and placebo groups. The results remained consistent when stratified by disorder. A mixed model analysis indicated that the DCS group exhibited lower scores of HAMD item 3 (suicide) compared with the placebo group throughout the follow-up period (p = 0.01). A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group. DCS may be therapeutically beneficial for patients with TRD who responded to ketamine infusion but have a residual suicidal risk.",2019,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"['32 patients with TRD (17 with major depression and 15 with bipolar depression', 'infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47\u2009±\u20094.11 at baseline', 'patients with treatment-resistant depression who responded to low-dose ketamine infusion', 'patients with TRD']","['DCS treatment', 'placebo', 'DCS', 'ketamine', 'D-cycloserine (DCS', 'D-cycloserine']","['total scores of HAMD', 'Depression symptoms', 'HAMD item 3 (suicide']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]",,0.143272,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. john.krystal@yale.edu.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan. tomsu0402@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0480-y']
191,32314120,Retention in HIV Care Among HIV-Seropositive Pregnant and Postpartum Women in Uganda: Results of a Randomized Controlled Trial.,"We tested an intervention that aimed to increase retention in antiretroviral therapy (ART) among HIV-positive pregnant and postpartum women, a population shown to be vulnerable to poor ART outcomes. 133 pregnant women initiating ART at 2 hospitals in Uganda used real time-enabled wireless pill monitors (WPM) for 1 month, and were then randomized to receive text message reminders (triggered by late dose-taking) and data-informed counseling through 3 months postpartum or standard care. We assessed ""full retention"" (proportion attending all monthly clinic visits and delivering at a study facility; ""visit retention"" (proportion of clinic visits attended); and ""postpartum retention"" (proportion retained at 3 months postpartum). Intention-to-treat and per protocol analyses found that retention was relatively low and similar between groups, with no significant differences. Retention declined significantly post-delivery. The intervention was unsuccessful in this population, which experiences suboptimal ART retention and is in urgent need of effective interventions.",2020,"We tested an intervention that aimed to increase retention in antiretroviral therapy (ART) among HIV-positive pregnant and postpartum women, a population shown to be vulnerable to poor ART outcomes.","['HIV-Seropositive Pregnant and Postpartum Women in Uganda', 'HIV Care', '133 pregnant women initiating ART at 2 hospitals in Uganda used real time-enabled wireless pill monitors (WPM) for 1\xa0month', 'HIV-positive pregnant and postpartum women']","['antiretroviral therapy (ART', 'text message reminders (triggered by late dose-taking) and data-informed counseling through 3\xa0months postpartum or standard care']",[],"[{'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],133.0,0.179961,"We tested an intervention that aimed to increase retention in antiretroviral therapy (ART) among HIV-positive pregnant and postpartum women, a population shown to be vulnerable to poor ART outcomes.","[{'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Sabin', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, Boston, MA, 02118, USA. lsabin@bu.edu.'}, {'ForeName': 'Nafisa', 'Initials': 'N', 'LastName': 'Halim', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Davidson H', 'Initials': 'DH', 'LastName': 'Hamer', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Simmons', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Sivani', 'Initials': 'S', 'LastName': 'Jonnalagadda', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Larson Williams', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Chemusto', 'Affiliation': 'Mildmay Uganda, Kampala, Uganda.'}, {'ForeName': 'Allen L', 'Initials': 'AL', 'LastName': 'Gifford', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Bonawitz', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Aroda', 'Affiliation': 'Mildmay Uganda, Kampala, Uganda.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'DeSilva', 'Affiliation': 'Westbrook College of Health Professions, University of New England, Portland, ME, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gasuza', 'Affiliation': 'Mildmay Uganda, Kampala, Uganda.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mukasa', 'Affiliation': 'Mildmay Uganda, Kampala, Uganda.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Messersmith', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, Boston, MA, 02118, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02875-5']
192,32180941,Regular intake of white kidney beans extract ( Phaseolus vulgaris L.) induces weight loss compared to placebo in obese human subjects.,"Scope
Phaseolus vulgaris L. is rich in alpha-amylase inhibitor and has been used for reducing glycemia and calories absorption through preventing or delaying the digestion of complex carbohydrate. A randomized, double-blinded, placebo-controlled study was conducted on obese volunteers to evaluate the degree of significate weight loss by regular intake Phaseolus vulgaris cultivated from Southwestern region of China.
Method
The volunteers were divided into two groups, homogeneous for age, gender, and body weight. Phaseolus vulgaris extract or placebo was given 2,400 mg per day before each daily meal for 35 consecutive days. Each subject's body weight, fat mass, body mass index, blood biochemical parameters, skinfold fat thickness, and waist/hip circumferences were monitored and analyzed.
Result and conclusion
As a result, the average amount of weight lost by the Phaseolus vulgaris extract group was 2.24 kg (average of 0.448 kg per week), compared with a 0.29 kg weight loss (average of 0.058 kg per week) in placebo group after 35 days. The differences between groups were significant ( p < .01). The body mass index decreased by an average of 0.79, and the body fat decreased by 1.53% on average compared to baseline ( p < .05). The thickness of subcutaneous fat was significantly reduced at the four measurement points, and the decrease of waist circumference and hip circumference was significant as well. No adverse or side effects were observed during the trial period. The results indicate that Phaseolus vulgaris extract can significantly induce weight loss in a short time period.",2020,"The thickness of subcutaneous fat was significantly reduced at the four measurement points, and the decrease of waist circumference and hip circumference was significant as well.","['obese human subjects', 'obese volunteers to evaluate the degree of significate weight loss by regular intake Phaseolus vulgaris cultivated from Southwestern region of China']","['placebo', 'white kidney beans extract ( Phaseolus vulgaris L']","['body fat', 'weight loss', 'average amount of weight lost', 'adverse or side effects', 'thickness of subcutaneous fat', 'body mass index', 'waist circumference and hip circumference']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1510487', 'cui_str': 'Phaseolus vulgaris'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1510487', 'cui_str': 'Phaseolus vulgaris'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}]",,0.0543535,"The thickness of subcutaneous fat was significantly reduced at the four measurement points, and the decrease of waist circumference and hip circumference was significant as well.","[{'ForeName': 'Shenli', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health College of Food Science and Nutrition Engineering China Agricultural University Beijing China.'}, {'ForeName': 'Lishui', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Brand Food R&D Center Nutrition & Health Research Institute (COFCO-NHRI) Beijing China.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Brand Food R&D Center Nutrition & Health Research Institute (COFCO-NHRI) Beijing China.'}, {'ForeName': 'Jinghan', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Brand Food R&D Center Nutrition & Health Research Institute (COFCO-NHRI) Beijing China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health School of Food and Health Beijing Technology & Business University Beijing China.'}, {'ForeName': 'Fazheng', 'Initials': 'F', 'LastName': 'Ren', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health College of Food Science and Nutrition Engineering China Agricultural University Beijing China.'}]",Food science & nutrition,['10.1002/fsn3.1299']
193,31375749,Effect of flavor on neuronal responses of the hypothalamus and ventral tegmental area.,"Although it is well known that food intake is affected by the palatability of food, the actual effect of flavoring on regulation of energy-homeostasis and reward perception by the brain, remains unclear. We investigated the effect of ethyl-butyrate (EB), a common non-caloric food flavoring, on the blood oxygen level dependent (BOLD) response in the hypothalamus (important in regulating energy homeostasis) and ventral tegmental area (VTA; important in reward processes). The 16 study participants (18-25 years, BMI 20-23 kg/m 2 ) drank four study stimuli on separate visits using a crossover design during an fMRI setup in a randomized order. The stimuli were; plain water, water with EB, glucose solution (50gram/300 ml) and glucose solution with EB. BOLD responses to ingestion of the stimuli were determined in the hypothalamus and VTA as a measure of changes in neuronal activity after ingestion. In the hypothalamus and VTA, glucose had a significant effect on the BOLD response but EB flavoring did not. Glucose with and without EB led to similar decrease in hypothalamic BOLD response and glucose with EB resulted in a decrease in VTA BOLD response. Our results suggest that the changes in neuronal activity in the hypothalamus are mainly driven by energy ingestion and EB does not influence the hypothalamic response. Significant changes in VTA neuronal activity are elicited by energy combined with flavor.",2019,Glucose with and without EB led to similar decrease in hypothalamic BOLD response and glucose with EB resulted in a decrease in VTA BOLD response.,"['16 study participants (18-25 years, BMI 20-23\u2009kg/m 2 ) drank four study stimuli on separate visits using a crossover design during an']","['plain water, water with EB, glucose solution (50gram/300\u2009ml) and glucose solution with EB', 'Glucose with and without EB', 'fMRI setup', 'ethyl-butyrate (EB', 'flavor']","['hypothalamic BOLD response and glucose with EB', 'neuronal activity', 'BOLD response', 'VTA BOLD response', 'neuronal responses of the hypothalamus and ventral tegmental area', 'VTA neuronal activity', 'blood oxygen level dependent (BOLD) response']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0242817', 'cui_str': 'Cross-Over Design'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0059755', 'cui_str': 'ethyl butyrate'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0020663', 'cui_str': 'Preoptico-Hypothalamic Area'}, {'cui': 'C0175405', 'cui_str': 'Area Tegmentalis Ventralis'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]",,0.0325444,Glucose with and without EB led to similar decrease in hypothalamic BOLD response and glucose with EB resulted in a decrease in VTA BOLD response.,"[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'van Opstal', 'Affiliation': 'Leiden University Medical Center, Department of Radiology, Leiden, The Netherlands. a.m.van_opstal@lumc.nl.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'van den Berg-Huysmans', 'Affiliation': 'Leiden University Medical Center, Department of Radiology, Leiden, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hoeksma', 'Affiliation': 'Unilever Research & Development, Vlaardingen, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Blonk', 'Affiliation': 'Unilever Research & Development, Vlaardingen, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Pijl', 'Affiliation': 'Leiden University Medical Center, Department of Internal Medicine, Section Endocrinology, Leiden, The Netherlands.'}, {'ForeName': 'S A R B', 'Initials': 'SARB', 'LastName': 'Rombouts', 'Affiliation': 'Leiden University Medical Center, Department of Radiology, Leiden, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Grond', 'Affiliation': 'Leiden University Medical Center, Department of Radiology, Leiden, The Netherlands.'}]",Scientific reports,['10.1038/s41598-019-47771-8']
194,32151567,Transcranial Direct Current Stimulation Applied to the Dorsolateral and Ventromedial Prefrontal Cortices in Smokers Modifies Cognitive Circuits Implicated in the Nicotine Withdrawal Syndrome.,"BACKGROUND
The nicotine withdrawal syndrome remains a major impediment to smoking cessation. Cognitive and affective disturbances are associated with altered connectivity within and between the executive control network, default mode network (DMN), and salience network. We hypothesized that functional activity in cognitive control networks, and downstream amygdala circuits, would be modified by application of transcranial direct current stimulation (tDCS) to the left (L) dorsolateral prefrontal cortex (dlPFC, executive control network) and right (R) ventromedial prefrontal cortex (vmPFC, DMN).
METHODS
A total of 15 smokers (7 women) and 28 matched nonsmokers (14 women) participated in a randomized, sham-controlled, double-blind, exploratory crossover study of 3 tDCS conditions: anodal-(L)dlPFC/cathodal-(R)vmPFC, reversed polarity, and sham. Cognitive tasks probed withdrawal-related constructs (error monitoring, working memory, amygdalar reactivity), while simultaneous functional magnetic resonance imaging measured brain activity. We assessed tDCS impact on trait (nonsmokers vs. sated smokers) and state (sated vs. abstinent) smoking aspects.
RESULTS
Single-session, anodal-(L)dlPFC/cathodal-(R)vmPFC tDCS enhanced deactivation of DMN nodes during the working memory task and strengthened anterior cingulate cortex activity during the error-monitoring task. Smokers were more responsive to tDCS-induced DMN deactivation when sated (vs. withdrawn) and displayed greater cingulate activity during error monitoring than nonsmokers. Nicotine withdrawal reduced task engagement and attention and reduced suppression of DMN nodes.
CONCLUSIONS
Cognitive circuit dysregulation associated with nicotine withdrawal may be modifiable by anodal tDCS applied to L-dlPFC and cathodal tDCS applied to R-vmPFC. tDCS may have stronger effects as a complement to existing therapies, such as nicotine replacement, owing to possible enhanced plasticity in the sated state.",2020,"Nicotine withdrawal reduced task engagement and attention and reduced suppression of DMN nodes.
","['15 smokers (7 women) and 28 matched nonsmokers (14 women', 'Smokers Modifies Cognitive Circuits']","['tDCS conditions: anodal-(L)dlPFC/cathodal-(R)vmPFC, reversed polarity, and sham', 'tDCS', 'Transcranial Direct Current Stimulation', 'Nicotine', 'anodal-(L)dlPFC/cathodal-(R)vmPFC tDCS']","['Cognitive tasks probed withdrawal-related constructs (error monitoring, working memory, amygdalar reactivity', 'Cognitive and affective disturbances', 'cingulate activity']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0260265,"Nicotine withdrawal reduced task engagement and attention and reduced suppression of DMN nodes.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Aronson Fischell', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, Maryland; School of Medicine, University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ross', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, Maryland.'}, {'ForeName': 'Zhi-De', 'Initials': 'ZD', 'LastName': 'Deng', 'Affiliation': 'Noninvasive Neuromodulation Unit, Experimental Therapeutics and Pathophysiology Branch, National Institute of Mental Health, Intramural Research Program, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Betty Jo', 'Initials': 'BJ', 'LastName': 'Salmeron', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, Maryland.'}, {'ForeName': 'Elliot A', 'Initials': 'EA', 'LastName': 'Stein', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, Maryland. Electronic address: estein@nih.gov.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2019.12.020']
195,31799616,Multielectrode Transcranial Electrical Stimulation of the Left and Right Prefrontal Cortices Differentially Impacts Verbal Working Memory Neural Circuitry.,"Recent studies have examined the effects of conventional transcranial direct current stimulation (tDCS) on working memory (WM) performance, but this method has relatively low spatial precision and generally involves a reference electrode that complicates interpretation. Herein, we report a repeated-measures crossover study of 25 healthy adults who underwent multielectrode tDCS of the left dorsolateral prefrontal cortex (DLPFC), right DLPFC, or sham in 3 separate visits. Shortly after each stimulation session, participants performed a verbal WM (VWM) task during magnetoencephalography, and the resulting data were examined in the time-frequency domain and imaged using a beamformer. We found that after left DLPFC stimulation, participants exhibited stronger responses across a network of left-lateralized cortical areas, including the supramarginal gyrus, prefrontal cortex, inferior frontal gyrus, and cuneus, as well as the right hemispheric homologues of these regions. Importantly, these effects were specific to the alpha-band, which has been previously implicated in VWM processing. Although stimulation condition did not significantly affect performance, stepwise regression revealed a relationship between reaction time and response amplitude in the left precuneus and supramarginal gyrus. These findings suggest that multielectrode tDCS targeting the left DLPFC affects the neural dynamics underlying offline VWM processing, including utilization of a more extensive bilateral cortical network.",2020,"Although stimulation condition did not significantly affect performance, stepwise regression revealed a relationship between reaction time and response amplitude in the left precuneus and supramarginal gyrus.","['25 healthy adults who underwent multielectrode tDCS of the left dorsolateral prefrontal cortex (DLPFC), right DLPFC, or sham in 3 separate visits']",['conventional transcranial direct current stimulation (tDCS'],"['working memory (WM) performance', 'reaction time and response amplitude']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",25.0,0.0283869,"Although stimulation condition did not significantly affect performance, stepwise regression revealed a relationship between reaction time and response amplitude in the left precuneus and supramarginal gyrus.","[{'ForeName': 'Sam M', 'Initials': 'SM', 'LastName': 'Koshy', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Alex I', 'Initials': 'AI', 'LastName': 'Wiesman', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Spooner', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Embury', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Rezich', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Heinrichs-Graham', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Tony W', 'Initials': 'TW', 'LastName': 'Wilson', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}]","Cerebral cortex (New York, N.Y. : 1991)",['10.1093/cercor/bhz246']
196,32059924,The impact of trauma characteristics on post-traumatic stress disorder and substance use disorder outcomes across integrated and substance use treatments.,"Proponents of complex post-traumatic stress disorder (PTSD) constructs suggest that specific trauma characteristics, such as earlier age of first trauma (trauma age) and higher number of traumas (trauma count), may obstruct PTSD symptom reduction in treatment. PTSD and substance use disorders (SUD) commonly co-occur, but the impact of trauma age and count on PTSD treatment responses in a comorbid PTSD and SUD sample is unclear. Further, no studies have examined the impact of trauma characteristics on SUD treatment outcomes or whether their impact on either PTSD or SUD outcomes varies if PTSD is directly addressed. A secondary analysis of a randomized controlled trial was conducted to examine: (1) whether trauma age and count influence comorbid PTSD and SUD (PTSD+SUD) responses during and following treatment; and (2) whether these effects differed across an exposure-based, integrated PTSD+SUD treatment (Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure; COPE) and a SUD-only focused treatment (Relapse Prevention Therapy; RPT). Individuals with PTSD+SUD randomized to COPE (n = 39) or RPT (n = 43) provided weekly measurements of PTSD and SUD. Across COPE and RPT, earlier trauma age predicted reduced SUD improvement (B = -0.01, standard error = 0.00). Trauma count did not predict changes in PTSD or SUD during or following treatment. These findings suggest that excluding individuals from exposure-based, integrated treatments on the basis of trauma characteristics is not empirically supported. However, individuals with earlier trauma ages may require additional or unique clinical attention to improve their SUD outcomes.",2020,"Across COPE and RPT, earlier trauma age predicted reduced SUD improvement (B = -0.01, standard error = 0.00).",['individuals with earlier trauma ages'],"['SUD-only focused treatment (Relapse Prevention Therapy; RPT', 'COPE', 'RPT']","['trauma age and count influence comorbid PTSD and SUD (PTSD+SUD) responses', 'SUD improvement', 'Trauma count']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}]","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]",,0.0416171,"Across COPE and RPT, earlier trauma age predicted reduced SUD improvement (B = -0.01, standard error = 0.00).","[{'ForeName': 'Skye', 'Initials': 'S', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Psychology, York University, 4700 Keele St., North York, ON M3J 1P3, Canada. Electronic address: skyefitz@yorku.ca.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Saraiya', 'Affiliation': 'Derner School of Psychology, Adelphi University, One South Avenue, P.O. Box 701, Garden City, NY 11530-0701, United States of America.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lopez-Castro', 'Affiliation': 'Psychology Department, The City College of New York, CUNY, 160 Covent Ave., New York, NY 10031, United States of America.'}, {'ForeName': 'Lesia M', 'Initials': 'LM', 'LastName': 'Ruglass', 'Affiliation': 'Center of Alcohol Studies, Graduate School of Applied and Professional Psychology, Rutgers University, 607 Allison Road, Piscataway, NJ 08854, United States of America.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Hien', 'Affiliation': 'Center of Alcohol Studies, Graduate School of Applied and Professional Psychology, Rutgers University, 607 Allison Road, Piscataway, NJ 08854, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.01.012']
197,32272901,A dual efficacy-implementation trial of a novel mobile application for childhood nephrotic syndrome management: the UrApp for childhood nephrotic syndrome management pilot study protocol (UrApp pilot study).,"BACKGROUND
Idiopathic nephrotic syndrome has a relapsing-remitting course in the majority of pediatric patients, demanding vigilant monitoring and self-management. A novel, expert-designed, user-informed mobile application (app), UrApp©, was created to support management tasks, including home urine protein monitoring.
METHODS
The UrApp Pilot Study (ClinicalTrials.gov, NCT04075656) is a randomized trial comparing UrApp-supported nephrotic syndrome management with standard-of-care with parallel process evaluation of the intervention delivery. Sixty caregivers of children with newly diagnosed, steroid-sensitive nephrotic syndrome will be randomized 1:1 to UrApp-supported care or standard-of-care. Follow-up will be 1 year, with primary outcomes of adherence to urine monitoring and medications assessed at 6 and 12 months. Secondary outcomes at 6 and 12 months include self-efficacy, quality-of-life, hospitalizations and delayed relapse diagnoses. A mixed-methods approach will evaluate UrApp engagement, use retention, features used, user perceptions, and contextual barriers and facilitators of UrApp use. User behavior will be assessed for relationships to the primary and secondary outcomes. A Stakeholder Committee of volunteer trial participants, clinicians, and engineers will examine the trial results and design a pragmatic UrApp-enhanced nephrotic syndrome intervention with potential for wide implementation. The final UrApp intervention will be tested in a user-centered hybrid effectiveness-implementation trial designed with stakeholder input.
DISCUSSION
The UrApp Pilot Study examines the efficacy of a novel app designed specifically for nephrotic syndrome. The protocol involves dual efficacy and process evaluation aims to increase efficiency and incorporates the stakeholders' perspective in formative assessment to inform intervention redesign and the design of a future user-centered trial.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04075656. Registered on September 2, 2019, https://clinicaltrials.gov/ct2/show/NCT04075656.",2020,"Secondary outcomes at 6 and 12 months include self-efficacy, quality-of-life, hospitalizations and delayed relapse diagnoses.","['Sixty caregivers of children with newly diagnosed, steroid-sensitive nephrotic syndrome', 'childhood nephrotic syndrome management', 'nephrotic syndrome']",['novel mobile application'],"['self-efficacy, quality-of-life, hospitalizations and delayed relapse diagnoses']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0403396', 'cui_str': 'Steroid-sensitive nephrotic syndrome'}, {'cui': 'C3874381', 'cui_str': 'Childhood nephrotic syndrome'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic syndrome'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.12518,"Secondary outcomes at 6 and 12 months include self-efficacy, quality-of-life, hospitalizations and delayed relapse diagnoses.","[{'ForeName': 'Chia-Shi', 'Initials': 'CS', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA. chia-shi.wang@emory.edu.'}, {'ForeName': 'Cam', 'Initials': 'C', 'LastName': 'Escoffery', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Emory University Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Patzer', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'McCracken', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Ross', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Rheault', 'Affiliation': ""University of Minnesota Masonic Children's Hospital, Minneapolis, GA, USA.""}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Al-Uzri', 'Affiliation': 'Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Greenbaum', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",BMC nephrology,['10.1186/s12882-020-01778-w']
198,31981106,Effects of Netarsudil and Latanoprost Alone and in Fixed Combination on Corneal Endothelium and Corneal Thickness: Post-Hoc Analysis of MERCURY-2.,"INTRODUCTION
To describe the changes in endothelial cell density (ECD), the coefficient of variation (CV), the percentage of hexagonal cells (%HEX), and central corneal thickness (CCT) following 3 months of therapy with netarsudil 0.02%/latanoprost 0.005% fixed combination, and to compare these changes with those seen with netarsudil 0.02% or latanoprost 0.005% in eyes with ocular hypertension or open-angle glaucoma.
METHODS
A subset of subjects enrolled in a Phase 3 evaluation of the intraocular pressure-lowering efficacy and safety of netarsudil 0.02%/latanoprost 0.005% fixed combination once daily (QD) versus each of its individual components underwent corneal endothelial cell imaging by specular microscopy and ultrasound pachymetry at baseline and following 3 months of therapy. Images were evaluated in masked fashion at an independent reading center. Changes from baseline to 3 months in ECD, CV, %HEX, and CCT were compared between treatment groups.
RESULTS
Data from 415 subjects obtained at both baseline and Month 3 were included in this post hoc analysis. Changes from baseline to Month 3 in ECD, CV, and %HEX were clinically insignificant in all three groups, and the changes in the netarsudil/latanoprost fixed combination group demonstrated no statistical difference from those seen in the netarsudil and latanoprost groups. Mean CCT decreased more in the fixed combination group (- 6.4 µm) than in either the netarsudil group (- 3.3 µm, p = 0.0248) or the latanoprost group (- 1.2 µm, p < 0.0001).
CONCLUSIONS
Netarsudil 0.2%/latanoprost 0.005% fixed combination QD for 3 months in eyes with ocular hypertension or open-angle glaucoma had no clinically significant effects on endothelial cell density or morphology. The significant decrease in CCT in the fixed combination group compared to the two individual component groups may indicate that the potential effects of each drug on CCT are additive, although the magnitude of the observed effects is likely of negligible clinical significance. CLINICALTRIALS.
GOV IDENTIFIER
NCT02674854.",2020,"Changes from baseline to Month 3 in ECD, CV, and %HEX were clinically insignificant in all three groups, and the changes in the netarsudil/latanoprost fixed combination group demonstrated no statistical difference from those seen in the netarsudil and latanoprost groups.","['415 subjects obtained at both baseline and Month 3', 'eyes with ocular hypertension or open-angle glaucoma']","['Netarsudil 0.2%/latanoprost 0.005% fixed combination QD', 'Netarsudil and Latanoprost Alone and in Fixed Combination', 'latanoprost', 'netarsudil 0.02%/latanoprost 0.005% fixed combination once daily (QD']","['endothelial cell density (ECD), the coefficient of variation (CV), the percentage of hexagonal cells (%HEX), and central corneal thickness (CCT', 'Corneal Endothelium and Corneal Thickness', 'Mean CCT', 'CCT', 'endothelial cell density or morphology']","[{'cui': 'C4517772', 'cui_str': 'Four hundred and fifteen'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}]","[{'cui': 'C4535718', 'cui_str': 'netarsudil'}, {'cui': 'C4517389', 'cui_str': '0.005'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0090306', 'cui_str': 'latanoprost acid'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0014259', 'cui_str': 'Corneal Endothelium'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}]",415.0,0.0504411,"Changes from baseline to Month 3 in ECD, CV, and %HEX were clinically insignificant in all three groups, and the changes in the netarsudil/latanoprost fixed combination group demonstrated no statistical difference from those seen in the netarsudil and latanoprost groups.","[{'ForeName': 'C Ellis', 'Initials': 'CE', 'LastName': 'Wisely', 'Affiliation': 'Duke University Eye Center, Durham, NC, USA.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Sheng', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, CA, USA. hsheng@aeriepharma.com.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Heah', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, CA, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Duke University Eye Center, Durham, NC, USA.'}]",Advances in therapy,['10.1007/s12325-020-01227-y']
199,32004648,"Minocycline 1.5% foam for the topical treatment of moderate to severe papulopustular rosacea: Results of 2 phase 3, randomized, clinical trials.","BACKGROUND
Efficacious topical medications for rosacea are needed. FMX103 1.5% is a novel topical minocycline foam that may have therapeutic benefits in treating rosacea while minimizing systemic adverse effects due to its topical route of delivery.
OBJECTIVE
To determine the efficacy, safety, and tolerability of 12 weeks of treatment with FMX103 1.5% topical minocycline foam for papulopustular rosacea.
METHODS
Two 12-week, phase 3, randomized, multicenter, double-blind, vehicle-controlled, 2-arm studies were performed in patients with moderate to severe papulopustular rosacea.
RESULTS
Participants who received FMX103 1.5%, versus control individuals treated with vehicle, exhibited a significantly greater reduction in the number of inflammatory lesions (FX2016-11: -17.57 vs -15.65; P = .0031; FX2016-12: -18.54 vs -14.88; P < .0001) and higher rates of Investigator Global Assessment treatment success (FX2016-11: 52.1% vs 43.0%; P = .0273; FX2016-12: 49.1% vs 39.0%; P = .0077). No serious treatment-related treatment-emergent adverse events occurred.
LIMITATIONS
The generalizability of these data from a controlled clinical trial should be examined in a real-world setting.
CONCLUSIONS
FMX103 1.5% was efficacious for moderate to severe papulopustular rosacea and maintained a favorable safety profile.",2020,"RESULTS
Subjects who received FMX103 1.5%, vs vehicle-treated controls, exhibited a significantly greater reduction in the number of inflammatory lesions (FX2016-11: -17.57 vs -15.65; P=.0031; FX2016-12: -18.54 vs -14.88; P<.0001) and higher rates of Investigator Global Assessment treatment success (FX2016-11: 52.1% vs 43.0%; P=.0273; FX2016-12: 49.1% vs 39.0%; P=.0077).","['Moderate-to-Severe Papulopustular Rosacea', 'papulopustular rosacea', 'patients with moderate-to-severe papulopustular rosacea']","['Minocycline 1.5% Foam', 'FMX103', 'FMX103 1.5% topical minocycline', 'minocycline']","['rates of Investigator Global Assessment treatment success', 'efficacy, safety, and tolerability', 'number of inflammatory lesions']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1449853', 'cui_str': 'Papulopustular Rosacea'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}]",,0.286328,"RESULTS
Subjects who received FMX103 1.5%, vs vehicle-treated controls, exhibited a significantly greater reduction in the number of inflammatory lesions (FX2016-11: -17.57 vs -15.65; P=.0031; FX2016-12: -18.54 vs -14.88; P<.0001) and higher rates of Investigator Global Assessment treatment success (FX2016-11: 52.1% vs 43.0%; P=.0273; FX2016-12: 49.1% vs 39.0%; P=.0077).","[{'ForeName': 'Linda Stein', 'Initials': 'LS', 'LastName': 'Gold', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'James Q', 'Initials': 'JQ', 'LastName': 'Del Rosso', 'Affiliation': 'JDR Dermatology Research/Thomas Dermatology, Las Vegas, Nevada.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Kircik', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Bhatia', 'Affiliation': 'Therapeutics Clinical Research, San Diego, California.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Hooper', 'Affiliation': 'Delricht Research, New Orleans, Louisiana.'}, {'ForeName': 'Walter K', 'Initials': 'WK', 'LastName': 'Nahm', 'Affiliation': 'University of California, San Diego School of Medicine, San Diego, California.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Stuart', 'Affiliation': 'Foamix Pharmaceuticals, Inc, Bridgewater, New Jersey. Electronic address: iain.stuart@foamix.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.01.043']
200,31967742,Duloxetine and pregabalin in neuropathic pain of lung cancer patients.,"INTRODUCTION
Neuropathic pain occurs in 1% of the population and is difficult to manage. This chronic pain causes psychological distress and impacts patient's quality of life, especially in cancer patients. The aim of this study was to show and compare the efficacy of pregabalin and duloxetine, which are reported in the group of first-line treatment at European Federation of Neurological Societies (EFNS) guidelines on the pharmacological treatment of neuropathic pain (2010 revision) in lung cancer patients by using visual analogue scale (VAS) and Leeds Assessment of Neuropathic Symptoms and Sign (LANSS).
PATIENTS AND METHODS
A prospective, randomized, open label, 3 month of study was conducted. A total of 44 patients that were diagnosed with neuropathic pain (14 women and 30 men) were included in the study. Patient's LANSS and VAS values were recorded before treatment. Then, 22 patients undergo pregabalin and 22 patients undergo duloxetine therapy. But due to side effects (dizziness, constipation), two patients had stopped to use pregabalin. Their LANSS and VAS values were recorded after 1 and 3 months of therapy.
RESULTS
When we compare LANSS and VAS scores before treatment, after 1 and 3 months of treatment with pregabalin and duloxetine, a significant decrease was observed in both groups at the 1 and 3 months (p < .01). Duloxetine is superior to pregabalin in reducing the LANSS scores when we compare two groups.
CONCLUSIONS
Both duloxetine and pregabalin are effective in the treatment of neuropathic pain of lung cancer patients. And as far as we know, this is the first study comparing the efficacy of duloxetine and pregabalin in the neuropathic pain of lung cancer patients.",2020,"Duloxetine is superior to pregabalin in reducing the LANSS scores when we compare two groups.
","['lung cancer patients by using visual analogue scale (VAS) and Leeds Assessment of Neuropathic Symptoms and Sign (LANSS', '44 patients that were diagnosed with neuropathic pain (14 women and 30 men', 'cancer patients', '22 patients undergo pregabalin and 22 patients undergo', 'lung cancer patients']","['Duloxetine', 'pregabalin', 'duloxetine', 'duloxetine therapy', 'Duloxetine and pregabalin', 'duloxetine and pregabalin', 'pregabalin and duloxetine']","['LANSS and VAS values', 'side effects (dizziness, constipation', 'VAS values', 'neuropathic pain', 'LANSS scores', 'LANSS and VAS scores']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",44.0,0.048107,"Duloxetine is superior to pregabalin in reducing the LANSS scores when we compare two groups.
","[{'ForeName': 'Şule Karabulut', 'Initials': 'ŞK', 'LastName': 'Gül', 'Affiliation': 'Department of Radiation Oncology, Dr.Lutfi Kirdar Kartal Education and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Tepetam', 'Affiliation': 'Department of Radiation Oncology, Dr.Lutfi Kirdar Kartal Education and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Hakan Levent', 'Initials': 'HL', 'LastName': 'Gül', 'Affiliation': 'Sport Sciences Faculty, Istanbul Gedik University, Istanbul, Turkey.'}]",Brain and behavior,['10.1002/brb3.1527']
201,31993943,Design and Rationale of a Scandinavian Multicenter Randomized Study Evaluating if Once-Daily Tacrolimus Versus Twice-Daily Cyclosporine Reduces the 3-year Incidence of Chronic Lung Allograft Dysfunction After Lung Transplantation (ScanCLAD Study).,"BACKGROUND
A low level of evidence exists regarding the choice of calcineurin inhibitor (CNI) for immunosuppression after lung transplantation (LTx). Therefore, we designed a randomized clinical trial according to good clinical practice rules to compare tacrolimus with cyclosporine after LTx.
METHODS
The ScanCLAD study is an investigator-initiated, pragmatic, controlled, randomized, open-label, multicenter study evaluating if an immunosuppressive protocol based on anti-thymocyte globulin (ATG) induction, once-daily tacrolimus dose, mycophenolate mofetil, and corticosteroid reduces the incidence of chronic lung allograft dysfunction (CLAD) after LTx, compared to a cyclosporine-based protocol with all other immunosuppressive and prophylactic drugs being identical between groups. All patients will be followed for 3 years to determine the main endpoint of CLAD. The study is designed for superiority, and power calculations show that 242 patients are needed. Also, the study is designed with more than 10 substudies addressing other important and unresolved issues in LTx. In addition, the ScanCLAD study enabled the synchronization of the treatment and follow-up protocols of the lung transplantation programs of all five Scandinavian lung transplantation centers.
PLANNED OUTCOMES
Recruitment started in 2016. At the end of April 2019, 227 patients were randomized. We anticipate the last patient to be randomized in autumn 2019, and thus the last patient visits will be in 2022. The ScanCLAD study is enrolling and investigates which CNI is to be preferred from a CLAD perspective after LTx.
TRIAL REGISTRY NUMBER
ScanCLAD trial registered at ClinicalTrials.gov before patient enrollment (NCT02936505). EUDRACT number 2015-004137-27.",2020,"In addition, the ScanCLAD study enabled the synchronization of the treatment and follow-up protocols of the lung transplantation programs of all five Scandinavian lung transplantation centers.
","['242 patients are needed', '227 patients were randomized']","['immunosuppressive protocol based on anti-thymocyte globulin (ATG) induction, once-daily tacrolimus dose, mycophenolate mofetil, and corticosteroid', 'cyclosporine', 'tacrolimus with cyclosporine', 'Tacrolimus Versus Twice-Daily Cyclosporine', 'calcineurin inhibitor (CNI']","['3-year Incidence of Chronic Lung Allograft Dysfunction', 'incidence of chronic lung allograft dysfunction (CLAD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0009072', 'cui_str': 'Garments'}]",227.0,0.114135,"In addition, the ScanCLAD study enabled the synchronization of the treatment and follow-up protocols of the lung transplantation programs of all five Scandinavian lung transplantation centers.
","[{'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Dellgren', 'Affiliation': 'Department of Cardiothoracic Surgery, Sahlgrenska, University Hospital, Gothenburg, Sweden. goran.dellgren@vgregion.se.'}, {'ForeName': 'Thomas Kromann', 'Initials': 'TK', 'LastName': 'Lund', 'Affiliation': 'Section for Lung Transplantation, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Raivio', 'Affiliation': 'Department of Cardiac Surgery, Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Leuckfeld', 'Affiliation': 'Department of Respiratory Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Svahn', 'Affiliation': 'Department of Pulmonology, Lund University Hospital, Lund, Sweden.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Magnusson', 'Affiliation': 'Transplant Institute, Sahlgrenska, University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Gerdt C', 'Initials': 'GC', 'LastName': 'Riise', 'Affiliation': 'Transplant Institute, Sahlgrenska, University Hospital, Gothenburg, Sweden.'}]",Advances in therapy,['10.1007/s12325-020-01224-1']
202,32020565,"Prolonged-Release (PR) Oxycodone/Naloxone Improves Bowel Function Compared with Oxycodone PR and Provides Effective Analgesia in Chinese Patients with Non-malignant Pain: A Randomized, Double-Blind Trial.","INTRODUCTION
Prolonged-release oxycodone/naloxone (OXN PR), combining an opioid analgesic with selective blockade of enteric µ-opioid receptors, provided effective analgesia and improved bowel function in patients with moderate-to-severe pain and opioid-induced constipation in clinical trials predominantly conducted in Western countries. This double-blind randomized controlled trial investigated OXN PR (N = 116) versus prolonged-release oxycodone (OXY PR, N = 115) for 8 weeks at doses up to 50 mg/day in patients with moderate-to-severe, chronic, non-malignant musculoskeletal pain and opioid-induced constipation recruited in China.
METHODS
A total of 234 patients at least 18 years of age with non-malignant musculoskeletal pain for more than 4 weeks that was moderate-to-severe in intensity and required round-the-clock opioid therapy were randomized (1:1) to OXN PR or OXY PR. The primary endpoint was bowel function using the Bowel Function Index (BFI). Secondary endpoints included safety, Brief Pain Inventory-Short Form (BPI-SF), use of analgesic and laxative rescue medication, and health-related quality of life (EQ-5D).
RESULTS
While BFI scores were comparable at baseline, at week 8 improvements were greater with OXN PR vs OXY PR (least squares mean [LSM] difference (95% CI) - 9.1 (- 14.0, - 4.2); P < 0.001. From weeks 2 to 8, mean BFI scores were in the range of normal bowel function (≤ 28.8) with OXN PR but were in the range of constipation (> 28.8) at all timepoints with OXY PR. Analgesia with OXN PR was similar and non-inferior to OXY PR on the basis of modified BPI-SF average 24-h pain scores at week 8: LSM difference (95% CI) - 0.3 (- 0.5, - 0.1); P < 0.001. The most frequent treatment-related AEs were nausea (OXN PR 5% vs OXY PR 6%) and dizziness (4% vs 4%).
CONCLUSION
OXN PR provided clinically meaningful improvements in bowel function and effective analgesia in Chinese patients with moderate-to-severe musculoskeletal pain and pre-existing opioid-induced constipation.
TRIAL REGISTRATION
ClinicalTrials.gov, identifier NCT01918098.",2020,"Analgesia with OXN PR was similar and non-inferior to OXY PR on the basis of modified BPI-SF average 24-h pain scores at week 8: LSM difference (95% CI) - 0.3 (- 0.5, - 0.1); P < 0.001.","['Chinese Patients with Non-malignant Pain', 'patients with moderate-to-severe, chronic, non-malignant musculoskeletal pain and opioid-induced constipation recruited in China', 'Chinese patients with moderate-to-severe musculoskeletal pain and pre-existing opioid-induced constipation', '234 patients at least 18\xa0years of age with non-malignant musculoskeletal pain for more than 4\xa0weeks that was moderate-to-severe in intensity and required round-the-clock opioid therapy', 'patients with moderate-to-severe pain and opioid-induced constipation in clinical trials predominantly conducted in Western countries']","['Naloxone', 'OXN PR', 'OXN PR (N\u2009=\u2009116) versus prolonged-release oxycodone (OXY PR, N\u2009=\u2009115', 'OXN PR or OXY PR', 'naloxone (OXN PR', 'Oxycodone PR', 'Oxycodone']","['Bowel Function', 'modified BPI-SF average 24-h pain scores', 'Prolonged-Release (PR', 'bowel function using the Bowel Function Index (BFI', 'nausea (OXN PR', 'bowel function and effective analgesia', 'safety, Brief Pain Inventory-Short Form (BPI-SF), use of analgesic and laxative rescue medication, and health-related quality of life (EQ-5D', 'mean BFI scores', 'dizziness', 'BFI scores']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C3160897'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C4544856', 'cui_str': 'Prolonged-release (release characteristic)'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}]","[{'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C4544856', 'cui_str': 'Prolonged-release (release characteristic)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",234.0,0.404247,"Analgesia with OXN PR was similar and non-inferior to OXY PR on the basis of modified BPI-SF average 24-h pain scores at week 8: LSM difference (95% CI) - 0.3 (- 0.5, - 0.1); P < 0.001.","[{'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Leng', 'Affiliation': 'Rheumatology and Immunology Department, Peking Union Medical College Hospital, Peking, China.'}, {'ForeName': 'Fengxiao', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Rheumatology and Immunology Department, Hebei General Hospital, Shijiazhuang, China.'}, {'ForeName': 'Shanglong', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Anesthesiology Department, Wuhan Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xisheng', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'Osteology Department, Peking Union Medical College Hospital, Peking, China.'}, {'ForeName': 'Kaizhi', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Anesthesiology Department, The First Affiliated Hospital of Third Military Medical University (TMMU), Chongqing, China.'}, {'ForeName': 'Gouzhong', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Anesthesiology Department, Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Anesthesiology Department, The General Hospital of Shenyang Military Region, Shenyang, China.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Anesthesiology Department, Peking Union Medical College Hospital, Peking, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Rheumatology and Immunology Department, Peking Union Medical College Hospital, Peking, China. xiaofeng.zeng@cstar.org.cn.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hopp', 'Affiliation': 'Mundipharma Research GmbH & Co.KG, Limburg, Germany.'}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Lu', 'Affiliation': 'Mundipharma (China) Pharmaceutical Co. Ltd, Beijing, China.'}]",Advances in therapy,['10.1007/s12325-020-01244-x']
203,32306296,Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.,"INTRODUCTION
The safety and efficacy of exenatide once weekly (EQW) is overall well established. EQW is primarily renally eliminated. In this study, the efficacy and renal and gastrointestinal tolerability of EQW were summarised in participants with type 2 diabetes and chronic kidney disease stage 3 (CKD3; moderate renal impairment; estimated glomerular filtration rate [eGFR] ≥ 30 to < 60 mL/min/1.73 m 2 ) or CKD stage 2 (CKD2; mild renal impairment; eGFR ≥ 60 to < 90 mL/min/1.73 m 2 ).
METHODS
Data on participants with type 2 diabetes and baseline CKD3 or CKD2 from eight phase 3, double-blind or open-label studies with 26- or 28-week controlled treatment periods were pooled. Participants received EQW or a placebo/non-glucagon-like peptide-1 receptor agonist comparator (sitagliptin, metformin, pioglitazone, dapagliflozin and insulin).
RESULTS
Participants with baseline CKD3 (N = 182) or CKD2 (N = 772) receiving EQW differed in a number of baseline characteristics, such as age < 65 years, race, mean body mass index and mean type 2 diabetes duration, whereas mean blood pressure and glycated haemoglobin (HbA 1c ) were similar. Mean reductions in HbA 1c , body weight and systolic blood pressure from baseline to week 26/28 in participants receiving EQW were similar between the CKD subgroups. The proportions of participants (CKD3 and CKD2) with any adverse event (AE) were 81% and 72%, respectively, for EQW and 74% and 68%, respectively, for all comparators; those for serious AEs were 2.7% and 3.4%, respectively, for EQW and 6% and 5%, respectively, for all comparators. Gastrointestinal AE rates were higher in the EQW CKD3 subgroup (42.2% of participants) than in the CKD2 (32.8%) subgroup, although rates for nausea and vomiting were similar. There were no dehydration events; one participant in each treatment group had a serious AE of acute kidney injury (EQW with CKD3, n = 1; pioglitazone with CKD2, n = 1).
CONCLUSION
Exenatide once weekly was well tolerated and demonstrated similar efficacy in participants with type 2 diabetes with mild and moderate renal impairment.
TRIAL REGISTRATION
ClinicalTrials.gov identifiers: NCT00637273, NCT00676338, NCT02229383, NCT02229396, NCT00641056, NCT01652729, NCT00935532, NCT01003184.",2020,"Gastrointestinal AE rates were higher in the EQW CKD3 subgroup (42.2% of participants) than in the CKD2 (32.8%) subgroup, although rates for nausea and vomiting were similar.","['Participants with baseline', 'participants with type 2 diabetes and chronic kidney disease stage 3 (CKD3; moderate renal impairment; estimated glomerular filtration rate [eGFR]\u2009≥\u200930 to\u2009<\u200960\xa0mL', 'participants with type 2 diabetes and', 'participants with type 2 diabetes with mild and moderate renal impairment', 'Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease']","['EQW', 'exenatide', 'pioglitazone', 'Exenatide', 'CKD3', 'EQW or a placebo/non-glucagon-like peptide-1 receptor agonist comparator (sitagliptin, metformin, pioglitazone, dapagliflozin and insulin']","['Safety and Efficacy', 'mean blood pressure and glycated haemoglobin (HbA 1c ', 'safety and efficacy', 'nausea and vomiting', 'Gastrointestinal AE rates', 'efficacy and renal and gastrointestinal tolerability', 'adverse event (AE', 'serious AE of acute kidney injury', 'Mean reductions in HbA 1c , body weight and systolic blood pressure']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.191815,"Gastrointestinal AE rates were higher in the EQW CKD3 subgroup (42.2% of participants) than in the CKD2 (32.8%) subgroup, although rates for nausea and vomiting were similar.","[{'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Guja', 'Affiliation': '""Carol Davila"" University of Medicine and Pharmacy, Bucharest, Romania. cristian.guja@b.astral.ro.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frías', 'Affiliation': 'National Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Suchower', 'Affiliation': 'Kelly Services, Gaithersburg, MD, USA.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hardy', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Marr', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Jabbour', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00815-z']
204,32305259,Management of early pregnancy loss with mifepristone and misoprostol: clinical predictors of treatment success from a randomized trial.,"BACKGROUND
Early pregnancy loss is a common event in the first trimester, occurring in 15%-20% of confirmed pregnancies. A common evidence-based medical regimen for early pregnancy loss uses misoprostol, a prostaglandin E1 analog, with a dosage of 800 μg, self-administered vaginally. The clinical utility of this regimen is limited by suboptimal effectiveness in patients with a closed cervical os, with 29% of patients experiencing early pregnancy loss requiring a second dose after 3 days and 16% of patients eventually requiring a uterine aspiration procedure.
OBJECTIVE
This study aimed to evaluate clinical predictors associated with treatment success in patients receiving medical management with mifepristone-misoprostol or misoprostol alone for early pregnancy loss.
STUDY DESIGN
We performed a planned secondary analysis of a randomized trial comparing mifepristone-misoprostol with misoprostol alone for management of early pregnancy loss. The published prediction model for treatment success of single-dose misoprostol administered vaginally included the following variables: active bleeding, type of early pregnancy loss (anembryonic pregnancy or embryonic and/or fetal demise), parity, gestational age, and treatment site; previous significant predictors were vaginal bleeding within the past 24 hours and parity of 0 or 1 vs >1. To determine if these characteristics predicted differential proportions of patients with treatment success or failure, we performed bivariate analyses; given the small proportion of treatment failures in the combined treatment arm, both arms were combined for analysis. Thereafter, we performed a logistic regression analysis to assess the effect of these predictors collectively in each of the 2 treatment groups separately as well as in the full cohort as a proxy for the combined treatment arm. Finally, by using receiver operating characteristic curves, we tested the ability of these predictors in association with misoprostol treatment success to discriminate between treatment success and treatment failure. To quantify the ability of the score to discriminate between treatment success and treatment failure in each treatment arm as well as in the entire cohort, we calculated the area under the curve. Using multivariable logistic regression, we then assessed our study population for other predictors of treatment success in both treatment groups, with and without mifepristone pretreatment.
RESULTS
Overall, 297 evaluable participants were included in the primary study, with 148 in the mifepristone-misoprostol combined treatment group and 149 in the misoprostol-alone treatment group. Among patients who had vaginal bleeding at the time of treatment, 15 of 17 (88%) in the mifepristone-misoprostol combined treatment group and 12 of 17 (71%) in the misoprostol-alone treatment group experienced expulsion of pregnancy tissue. Among patients with a parity of 0 or 1, 94 of 108 (87%) in the mifepristone-misoprostol treatment group and 66 of 95 (69%) in the misoprostol-alone treatment group experienced expulsion of pregnancy tissue. These clinical characteristics did not predict treatment success in the combined cohort alone (area under the curve=0.56; 95% confidence interval, 0.48-0.64). No other baseline clinical factors predicted treatment success in the misoprostol-alone treatment arm or mifepristone pretreatment arm. In the full cohort, the significant predictors of treatment success were pretreatment with mifepristone (adjusted odds ratio=2.51; 95% confidence interval, 1.43-4.43) and smoking (adjusted odds ratio=2.15; 95% confidence interval, 1.03-4.49).
CONCLUSION
No baseline clinical factors predicted treatment success in women receiving medical management with misoprostol for early pregnancy loss. Adding mifepristone to the medical management regimen of early pregnancy loss improved treatment success; thus, mifepristone treatment should be considered for management of early pregnancy loss regardless of baseline clinical factors.",2020,No other baseline clinical factors predicted treatment success in the misoprostol-alone or mifepristone pretreatment arms individually.,"['alone for early pregnancy loss (EPL', 'women with a closed cervical os, with 29% of women with EPL requiring a second dose after three days, and 16% eventually requiring a uterine aspiration procedure', 'women with a parity of 0 or 1, 94/108 (87%) in the', 'women undergoing medical management of EPL with', 'women receiving medical management with', '297 evaluable subjects in the primary study, including 148 in the', 'combined and 149 in the misoprostol-alone groups', 'women who had vaginal bleeding at the time of treatment, 15/17 (88%) in the']","['prostaglandin E1 analogue misoprostol', 'misoprostol-alone', 'misoprostol-alone or mifepristone', 'mifepristone and misoprostol', 'mifepristone', 'mifepristone-misoprostol or misoprostol', 'mifepristone-misoprostol', 'misoprostol']","['vaginal bleeding', 'pregnancy']","[{'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C1185785', 'cui_str': 'External os structure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002335', 'cui_str': 'Alprostadil'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}]","[{'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",,0.312621,No other baseline clinical factors predicted treatment success in the misoprostol-alone or mifepristone pretreatment arms individually.,"[{'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Sonalkar', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, Hospital of the University of Pennsylvania, Philadelphia, PA. Electronic address: sarita.sonalkar@pennmedicine.upenn.edu.'}, {'ForeName': 'Nathanael', 'Initials': 'N', 'LastName': 'Koelper', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Research on Reproduction and Women's Health, Philadelphia, PA.""}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Creinin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Atrio', 'Affiliation': 'Department of Obstetrics and Gynecology, Montefiore Hospital and Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Department of Biostatistics and Informatics, Center for Integrative Design and Analysis, Colorado School of Public Health, Denver, CO.'}, {'ForeName': 'Arden', 'Initials': 'A', 'LastName': 'McAllister', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, Hospital of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, Hospital of the University of Pennsylvania, Philadelphia, PA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.04.006']
205,32306485,Neural function during emotion processing and modulation associated with treatment response in a randomized clinical trial for posttraumatic stress disorder.,"BACKGROUND
Posttraumatic stress disorder (PTSD) has been associated with exaggerated threat processing and deficits in emotion modulation circuitry. It remains unknown how neural circuits are associated with response to evidence-based treatments for PTSD.
METHOD
We examined associations between PTSD symptoms and indicators of neural response in key emotion processing and modulation regions. Fifty-six military Veterans with PTSD were randomly assigned to one of three evidence-based treatments (prolonged exposure, sertraline, and PE plus sertraline) in a randomized clinical trial (""PROGrESS""; 2018, Contemp Clin Trials, 64, 128-138). Twenty-seven combat-exposed controls (CCs) served as a comparison group at pretreatment. Before and after PTSD treatment, functional magnetic resonance imaging was used to assess brain activation and connectivity during the validated Shifted Attention Emotion Appraisal Task (2003, J Neurosci, 23, 5627-5633; 2013, Biol Psychiatry, 73, 1045-1053).
RESULTS
Greater activation in emotion processing (anterior insula) and modulation (prefrontal cortex) regions and increased connectivity between attentional control (dorsolateral prefrontal cortex and superior parietal cortex) and emotion processing (amygdala) regions, at pretreatment, were associated with subsequent PTSD symptom improvement.
CONCLUSIONS
This study is one of the first to examine task-based activation and functional connectivity in a PTSD treatment trial, and provides evidence to suggest that activation in and connectivity between emotion processing and modulation regions are important predictors of treatment response.",2020,"RESULTS
Greater activation in emotion processing (anterior insula) and modulation (prefrontal cortex) regions and increased connectivity between attentional control (dorsolateral prefrontal cortex and superior parietal cortex) and emotion processing (amygdala) regions, at pretreatment, were associated with subsequent PTSD symptom improvement.
","['posttraumatic stress disorder', 'Posttraumatic stress disorder (PTSD', 'Fifty-six military Veterans with PTSD']","['evidence-based treatments (prolonged exposure, sertraline, and PE plus sertraline']","['emotion processing (anterior insula) and modulation (prefrontal cortex) regions and increased connectivity between attentional control (dorsolateral prefrontal cortex and superior parietal cortex) and emotion processing (amygdala) regions', 'brain activation and connectivity', 'subsequent PTSD symptom improvement']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0228259', 'cui_str': 'Anterior insula'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0030560', 'cui_str': 'Parietal lobe structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",56.0,0.0198617,"RESULTS
Greater activation in emotion processing (anterior insula) and modulation (prefrontal cortex) regions and increased connectivity between attentional control (dorsolateral prefrontal cortex and superior parietal cortex) and emotion processing (amygdala) regions, at pretreatment, were associated with subsequent PTSD symptom improvement.
","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Duval', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Jony', 'Initials': 'J', 'LastName': 'Sheynin', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'King', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry and Behavioral Health, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Martis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Porter', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'Research Service, VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Mental Health Service Line, VA Atlanta Healthcare System, Decatur, Georgia.'}]",Depression and anxiety,['10.1002/da.23022']
206,32276003,The beneficial role of FeNO in association with GINA guidelines for titration of inhaled corticosteroids in adult asthma: A randomized study.,"PURPOSE
This study aimed to demonstrate the role of fractional concentration of exhaled nitric oxide (FeNO) in association with Global Initiative for Asthma (GINA) guidelines for treatment of adult patients with asthma.
METHODS
It was a prospective and randomized study. The symptomatic asthmatic patients were randomly divided into two groups: GINA group (followed GINA guidelines; N = 86) or GINA + FeNO group (followed GINA guidelines + FeNO for titration of inhaled corticosteroids - ICS; N = 90). They were followed-up for 9 months.
RESULTS
In GINA group, 37.2% patients had no treatment and 62.8% patients discontinued treatment vs. 40.0% and 60.0% in GINA + FeNO, respectively. After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups. At 9th month, Δ moderate asthma (reduction) in GINA + FeNO group was significantly higher than in the GINA group (-22.0% vs. -11.6%; P = 0.018). The improvement of asthma control test (ACT) score was not different between the groups at 9th month (12 ± 6 vs. 10 ± 5; P > 0.05); the level of FeNO reduction in GINA + FeNO group was significantly higher than that in GINA group (-42 ± 11 vs. -35 ± 9; P = 0.022). The daily dose of ICS in GINA + FeNO group was significantly lower than that in GINA group (397 ± 171 vs. 482 ± 240 mcg and 375 ± 203 vs. 424 ± 221 mcg; respectively) at the end of 6 and 9 months.
CONCLUSION
The use of FeNO in association with GINA guidelines has a beneficial role for accurate daily dose of ICS in adult patients with asthma.",2020,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","['symptomatic asthmatic patients', 'adult asthma', 'adult patients with asthma']","['GINA group (followed GINA guidelines; N\xa0=\xa086) or GINA\xa0+\xa0FeNO group (followed GINA guidelines\xa0+\xa0FeNO for titration of inhaled corticosteroids - ICS; N\xa0=\xa090', 'exhaled nitric oxide (FeNO', 'GINA']","['percentage of mild, moderate and severe asthma', 'level of FeNO reduction', 'improvement of asthma control test (ACT) score']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",,0.0308658,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","[{'ForeName': 'Tung', 'Initials': 'T', 'LastName': 'Truong-Thanh', 'Affiliation': 'Department of Internal Medicine, Thanh Hoa General Hospital, Thanh Hoa City, Vietnam.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Vo-Thi-Kim', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Vu-Minh', 'Affiliation': 'Department of Airway Diseases, ENT Institute, Hanoi City, Vietnam.'}, {'ForeName': 'Dung', 'Initials': 'D', 'LastName': 'Truong-Viet', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Huong', 'Initials': 'H', 'LastName': 'Tran-Van', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Sy', 'Initials': 'S', 'LastName': 'Duong-Quy', 'Affiliation': 'Department of Respiratory Diseases, Lam Dong Medical College, Dalat City, Vietnam; Department of Immuno-Allergology, Penn State Medical College, Hershey, USA. Electronic address: sduongquy.jfvp@gmail.com.'}]",Advances in medical sciences,['10.1016/j.advms.2020.03.001']
207,32016788,Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR : A Randomized Controlled Trial.,"PURPOSE
To evaluate efficacy and safety of intravitreal injections of aflibercept (IVT-AFL) treat-and-extend (T&E) dosing regimens in treatment-naïve patients with exudative age-related macular degeneration (AMD).
METHODS
Adults aged at least 50 years old with exudative AMD and best-corrected visual acuity (BCVA) of 73-25 Early Treatment Diabetic Retinopathy Study (ETDRS) letters were included. Patients received three monthly doses of IVT-AFL 2 mg. At week 16, patients were randomized 1:1 to IVT-AFL T&E with either 2- or 4-week adjustments. The primary endpoint was mean change in BCVA from baseline to week 52. Outcomes were assessed at weeks 52 and 96.
RESULTS
Baseline characteristics were comparable between the groups (n = 123 each). Over 52 weeks, mean number of injections was 7.2 and 6.9 and mean last injection interval was 10.7 and 11.8 weeks, for the 2- and 4-week groups, respectively. From baseline, mean change in BCVA was + 9.0 and + 8.4 letters (week 52) and + 7.6 and + 6.1 letters (week 96); mean change in central retinal thickness was - 134.4 µm and - 126.1 µm (week 52) and - 130.5 µm and - 125.3 µm (week 96). Last injection interval before week 52 was at least 12 weeks in 42.3% and 49.6% of patients and 56.9% and 60.2% before week 96. Over 96 weeks, mean number of injections was 10.4 (both groups). The safety profile of IVT-AFL was consistent with previous reports.
CONCLUSIONS
IVT-AFL administered using two different T&E regimens for treatment-naïve exudative AMD improved functional and anatomic outcomes at week 52 and outcomes were maintained to week 96. Outcomes were similar between the 2- and 4-week groups.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT02305238.",2020,"Outcomes were similar between the 2- and 4-week groups.
","['Adults aged at least 50\xa0years old with exudative AMD and best-corrected visual acuity (BCVA) of 73-25 Early Treatment Diabetic Retinopathy Study (ETDRS) letters were included', 'Exudative Age-Related Macular Degeneration', 'treatment-naïve patients with exudative age-related macular degeneration (AMD']","['IVT-AFL', 'ALTAIR ', 'Intravitreal Aflibercept Treat-and-Extend Regimens', 'aflibercept (IVT-AFL) treat-and-extend (T&E', 'IVT-AFL T&E']","['Efficacy and Safety', 'mean change in BCVA', 'functional and anatomic outcomes', 'mean number of injections', 'central retinal thickness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0311438', 'cui_str': 'Exudative (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}]",,0.0767897,"Outcomes were similar between the 2- and 4-week groups.
","[{'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Ohji', 'Affiliation': 'Department of Ophthalmology, Shiga University of Medical Science, Seta Tsukinowa-cho, Otsu, Shiga, Japan. eye.ohji@gmail.com.'}, {'ForeName': 'Kanji', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Ophthalmology, Kansai Medical University, School of Medicine, Hirakata City, Osaka, Japan.'}, {'ForeName': 'Annabelle A', 'Initials': 'AA', 'LastName': 'Okada', 'Affiliation': 'Department of Ophthalmology, Kyorin University, School of Medicine, Mitaka-shi, Tokyo, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Bayer Yakuhin Ltd, Marunouchi 1-chome, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Bayer Yakuhin Ltd, Umeda 2-chome, Kita-ku, Osaka, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Terano', 'Affiliation': 'Bayer Yakuhin Ltd, Umeda 2-chome, Kita-ku, Osaka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-020-01236-x']
208,32113011,Effects of dance intervention on frailty among older adults.,"OBJECTIVE
The aims of this study were to examine the effects of dance intervention on frailty in pre-frail and frail older persons.
DESIGN
This is a quasi-experimental, two-group trial.
SETTING
Older adults living nursing home.
PARTICIPANTS
Participants aged ≥ 60 years with low physical activity (mean age was 81.8 years; 71 % were female) (N = 66).
METHODS
Participants allocated to the dance group attended 40 min dance sessions in a nursing home, three times a week for 12-weeks. Participants allocated to the control group maintained their normal daily activities. Assessments were conducted at baseline, 6 weeks, and 12 weeks by researchers blinded to the allocation. Frailty was measured based on Fried criteria. Estimates of frailty between groups over time were calculated using the generalized estimating equations (GEE) and mixed effects models.
RESULTS
The prevalence of frailty decreased over time in the dance group compared to the control group (P = 0.002). The mean frailty scores decreased 0.69 at 6 weeks and 1.06 at 12 weeks. Compared to the control group, the prevalence of slowness (p = 0.002), weakness (p = 0.005), and low physical activity (p < 0.001) significantly decreased in the dance group.
CONCLUSIONS
Dance intervention may reduce the presence and severity of frailty in older adults. Slowness and low physical activity improve following 12 weeks of dance intervention.",2020,The prevalence of frailty decreased over time in the dance group compared to the control group (P = 0.002).,"['Participants aged ≥ 60 years with low physical activity (mean age was 81.8 years; 71 % were female', 'Older adults living nursing home', 'older adults', 'pre-frail and frail older persons']","['dance intervention', 'control group maintained their normal daily activities', 'dance group attended 40 min dance sessions']","['prevalence of frailty', 'Slowness and low physical activity', 'prevalence of slowness', 'weakness', 'low physical activity', 'mean frailty scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3714552', 'cui_str': 'Weakness - general'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0268148,The prevalence of frailty decreased over time in the dance group compared to the control group (P = 0.002).,"[{'ForeName': 'Xiangfei', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'School of Nursing, Jilin University, Changchun, China.'}, {'ForeName': 'Guichen', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, Changchun, China.'}, {'ForeName': 'Guangwei', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Respiratory Department of the First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Huiru', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'School of Nursing, Jilin University, Changchun, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'School of Nursing, Jilin University, Changchun, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, China.'}, {'ForeName': 'Binghan', 'Initials': 'B', 'LastName': 'Shang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China. Electronic address: fengshe738@sohu.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Jilin University, Changchun, China; Department of Pharmacology, College of Basic Medical Sciences, Jilin University, Changchun, China. Electronic address: chen_care@126.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2019.104001']
209,31719077,"Relieving acute pain (RAP) study: a proof-of-concept protocol for a randomised, double-blind, placebo-controlled trial.","INTRODUCTION
Physicians and other prescribing clinicians use opioids as the primary method of pain management after traumatic injury, despite growing recognition of the major risks associated with usage for chronic pain. Placebos given after repeated administration of active treatments can acquire medication-like effects based on learning mechanisms. This study hypothesises that dose-extending placebos can be an effective treatment in relieving clinical acute pain in trauma patients who take opioids.
METHODS AND ANALYSIS
The relieving acute pain is a proof-of-concept randomised, placebo-controlled, double-blinded, single-site study enrolling 159 participants aged from 18 to 65 years with one or more traumatic injuries treated with opioids. Participants will be randomly assigned to three different arms. Arm 1 will receive the full dose of opioids with non-steroidal anti-inflammatory drugs (NSAIDs). Arm 2 will receive the 50% overall reduction in opioid dosage, dose-extending placebos and NSAIDs. Arm 3 (control) will receive NSAIDs and placebos. The trial length will be 3 days of hospitalisation (phase I) and 2-week, 1-month, 3-month and 6-month follow-ups (exploratory phase II). Primary and secondary outcomes include feasibility and acceptability of the study. Pain intensity, functional pain, emotional distress, rates of rescue therapy requests and patient-initiated medication denials will be collected.
ETHICS AND DISSEMINATION
All activities associated with this protocol are conducted in full compliance with the Institutional Review Board policies and federal regulations. Publishing this study protocol will enable researchers and funding bodies to stay up to date in their fields by providing exposure to research activity that may not otherwise be widely publicised.
DATE AND PROTOCOL VERSION IDENTIFIER
3/6/2019 (HP-00078742).
TRIAL REGISTRATION NUMBER
NCT03426137.",2019,"This study hypothesises that dose-extending placebos can be an effective treatment in relieving clinical acute pain in trauma patients who take opioids.
","['159 participants aged from 18 to 65 years with one or more traumatic injuries treated with', 'trauma patients who take opioids']","['Placebos', 'opioids', 'placebo', 'opioids with non-steroidal anti-inflammatory drugs (NSAIDs', 'NSAIDs and placebos', 'placebos']","['feasibility and acceptability of the study', 'Pain intensity, functional pain, emotional distress, rates of rescue therapy requests and patient-initiated medication denials']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3263723', 'cui_str': 'Injuries'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011317', 'cui_str': 'Denial'}]",159.0,0.47272,"This study hypothesises that dose-extending placebos can be an effective treatment in relieving clinical acute pain in trauma patients who take opioids.
","[{'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, Baltimore, Maryland, USA colloca@umaryland.edu.'}, {'ForeName': 'Se Eun', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': 'Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Meghan Nichole', 'Initials': 'MN', 'LastName': 'Luhowy', 'Affiliation': 'Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, Maryland, USA.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Haycock', 'Affiliation': 'Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Chika', 'Initials': 'C', 'LastName': 'Okusogu', 'Affiliation': 'Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Soojin', 'Initials': 'S', 'LastName': 'Yim', 'Affiliation': 'Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Raghuraman', 'Affiliation': 'Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goodfellow', 'Affiliation': 'R Adams Cowley Shock Trauma Center, University of Maryland Medical Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Robert Scott', 'Initials': 'RS', 'LastName': 'Murray', 'Affiliation': 'R Adams Cowley Shock Trauma Center, University of Maryland Medical Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Casper', 'Affiliation': 'R Adams Cowley Shock Trauma Center, University of Maryland Medical Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Myounghee', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Investigational Drug Services, University of Maryland Medical Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Scalea', 'Affiliation': 'R Adams Cowley Shock Trauma Center, University of Maryland Medical Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Fouche', 'Affiliation': 'Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Murthi', 'Affiliation': 'R Adams Cowley Shock Trauma Center, University of Maryland Medical Center, Baltimore, Maryland, USA.'}]",BMJ open,['10.1136/bmjopen-2019-030623']
210,31705526,"Guselkumab is superior to fumaric acid esters in patients with moderate-to-severe plaque psoriasis who are naive to systemic treatment: results from a randomized, active-comparator-controlled phase IIIb trial (POLARIS).","BACKGROUND
Guselkumab, a fully human interleukin-23 antibody, is approved for systemic treatment of patients with moderate-to-severe plaque psoriasis.
OBJECTIVES
To compare the efficacy and safety of guselkumab with those of fumaric acid esters (FAE) in patients with moderate-to-severe plaque psoriasis who are naive to systemic treatment.
METHODS
Eligible patients were randomized to this multicentre, randomized, open-label, assessor-blinded, active-comparator-controlled phase IIIb study to receive guselkumab 100 mg by subcutaneous injection or oral FAE according to local label guidelines.
RESULTS
Through week 24, 56 of 60 patients completed guselkumab treatment and 36 of 59 completed FAE treatment. The primary endpoint (proportion of patients with ≥ 90% improvement from their baseline Psoriasis Area and Severity Index; PASI 90 response) was achieved by significantly more patients receiving guselkumab than FAE at week 24 (82% vs. 14%, P < 0·001). Analysis of the major secondary endpoints confirmed a statistically significant difference between the treatments with regards to PASI 75 response (90% vs. 27%, P < 0·001) and Dermatology Life Quality Index score of 0 or 1 (no effect at all on the patient's quality of life; 62% vs. 17%, P < 0·001). More patients in the guselkumab group achieved completely clear skin (PASI 100 response) than in the FAE group (32% vs. 3%, P < 0·001). The incidence of adverse events was lower with guselkumab than with FAE (73% vs. 98%). Overall, 28% of patients on FAE discontinued due to an adverse event, compared with none receiving guselkumab. No new safety findings were observed for guselkumab.
CONCLUSIONS
Guselkumab demonstrated superiority over FAE in systemic-treatment-naive patients with moderate-to-severe plaque psoriasis through 24 weeks.",2020,"Analysis of the major secondary endpoints confirmed a statistically significant difference between the treatments with regards to PASI 75 response (90.0% vs. 27.1%, p<0.001) and the Dermatology Life Quality Index (DLQI) response of 0/1 (no effect at all on patient's life; 61.7% vs. 16.9%, p<0.001).","['Eligible patients', 'patients with moderate-to-severe plaque psoriasis', 'systemic treatment-naïve patients with moderate-to-severe plaque psoriasis', 'patients with moderate-to-severe plaque psoriasis who are naïve to systemic treatment']","['FAE treatment', 'fumaric acid esters', 'Guselkumab', 'oral FAE', 'guselkumab with fumaric acid esters (FAE', 'guselkumab treatment', 'FAE']","['completely clear skin (PASI 100 response', 'PASI 75 response', 'incidence of adverse events (AE', 'baseline Psoriasis Area and Severity Index; PASI\xa090 response', 'Dermatology Life Quality Index (DLQI) response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1959568', 'cui_str': 'Fumarate Esters'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}]",,0.088747,"Analysis of the major secondary endpoints confirmed a statistically significant difference between the treatments with regards to PASI 75 response (90.0% vs. 27.1%, p<0.001) and the Dermatology Life Quality Index (DLQI) response of 0/1 (no effect at all on patient's life; 61.7% vs. 16.9%, p<0.001).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Centre for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pinter', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, University Hospital of Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sebastian', 'Affiliation': 'Dermatological Practice Dr. med. Michael Sebastian, Mahlow, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Termeer', 'Affiliation': 'Dermatological Practice Prof. Dr. med. Christian Termeer, Stuttgart, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sticherling', 'Affiliation': 'Department of Dermatology, University Hospital of Erlangen, Erlangen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gerdes', 'Affiliation': 'Psoriasis-Center, Department of Dermatology, Venerology and Allergology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wegner', 'Affiliation': 'Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Krampe', 'Affiliation': 'Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bartz', 'Affiliation': 'Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rausch', 'Affiliation': 'Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mensch', 'Affiliation': 'Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Eyerich', 'Affiliation': 'Department of Dermatology and Allergy, Technical University of Munich, Munich, Germany.'}]",The British journal of dermatology,['10.1111/bjd.18696']
211,31767584,"Impact of cardiopulmonary resuscitation on a cannot intubate, cannot oxygenate condition: a randomised crossover simulation research study of the interaction between two algorithms.","OBJECTIVES
During a 'cannot intubate, cannot oxygenate' situation, asphyxia can lead to cardiac arrest. In this stressful situation, two complex algorithms facilitate decision-making to save a patient's life: difficult airway management and cardiopulmonary resuscitation. However, the extent to which competition between the two algorithms causes conflicts in the execution of pivotal treatment remains unknown. Due to the rare incidence of this situation and the very low feasibility of such an evaluation in clinical reality, we decided to perform a randomised crossover simulation research study. We propose that even experienced healthcare providers delay cricothyrotomy, a lifesaving approach, due to concurrent cardiopulmonary resuscitation in a 'cannot intubate, cannot oxygenate' situation.
DESIGN
Due to the rare incidence and dynamics of such a situation, we conducted a randomised crossover simulation research study.
SETTING
We collected data in our institutional simulation centre between November 2016 and November 2017.
PARTICIPANTS
We included 40 experienced staff anaesthesiologists at our tertiary university hospital centre.
INTERVENTION
The participants treated two simulated patients, both requiring cricothyrotomy: one patient required cardiopulmonary resuscitation due to asphyxia, and one patient did not require cardiopulmonary resuscitation. Cardiopulmonary resuscitation was the intervention. Participants were evaluated by video records.
PRIMARY OUTCOME MEASURES
The difference in 'time to ventilation through cricothyrotomy' between the two situations was the primary outcome measure.
RESULTS
The results of 40 participants were analysed. No carry-over effects were detected in the crossover design. During cardiopulmonary resuscitation, the median time to ventilation was 22 s (IQR 3-40.5) longer than that without cardiopulmonary resuscitation (p=0.028), including the decision-making time.
CONCLUSION
Cricothyrotomy, which is the most crucial treatment for cardiac arrest in a 'cannot intubate, cannot oxygenate' situation, was delayed by concurrent cardiopulmonary resuscitation. If cardiopulmonary resuscitation delays cricothyrotomy, it should be interrupted to first focus on cricothyrotomy.",2019,"During cardiopulmonary resuscitation, the median time to ventilation was 22 s (IQR 3-40.5) longer than that without cardiopulmonary resuscitation (p=0.028), including the decision-making time.
","['our institutional simulation centre between November 2016 and November 2017', '40 participants were analysed', 'We included 40 experienced staff anaesthesiologists at our tertiary university hospital centre']","['cardiopulmonary resuscitation', 'cricothyrotomy: one patient required cardiopulmonary resuscitation due to asphyxia, and one patient did not require cardiopulmonary resuscitation']",['median time to ventilation'],"[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0004044', 'cui_str': 'Suffocation'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]",40.0,0.0279221,"During cardiopulmonary resuscitation, the median time to ventilation was 22 s (IQR 3-40.5) longer than that without cardiopulmonary resuscitation (p=0.028), including the decision-making time.
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ott', 'Affiliation': 'Department of Anaesthesiology, Johannes Gutenberg Universitat Mainz, Mainz, Germany ottth@uni-mainz.de.'}, {'ForeName': 'Jascha', 'Initials': 'J', 'LastName': 'Stracke', 'Affiliation': 'Department of Anaesthesiology, Johannes Gutenberg Universitat Mainz, Mainz, Germany.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Sellin', 'Affiliation': 'Department of Anaesthesiology, Johannes Gutenberg Universitat Mainz, Mainz, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kriege', 'Affiliation': 'Department of Anaesthesiology, Johannes Gutenberg Universitat Mainz, Mainz, Germany.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Toenges', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics, Johannes Gutenberg Universitat Mainz, Mainz, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Lott', 'Affiliation': 'Department of Anaesthesiology, Johannes Gutenberg Universitat Mainz, Mainz, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kuhn', 'Affiliation': 'Department of Orthopaedics and Traumatology, Johannes Gutenberg Universitat Mainz, Mainz, Germany.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Engelhard', 'Affiliation': 'Department of Anaesthesiology, Johannes Gutenberg Universitat Mainz, Mainz, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-030430']
212,31719078,"STOP-Colitis pilot trial protocol: a prospective, open-label, randomised pilot study to assess two possible routes of faecal microbiota transplant delivery in patients with ulcerative colitis.","INTRODUCTION
Imbalance of the gut microbiome is key to the pathogenesis of ulcerative colitis (UC). Faecal microbiota transplant (FMT) is the transfer of homogenised and filtered faeces from a healthy individual to the gastrointestinal tract of a patient with disease. Published datasets show a positive signal for the use of FMT to treat UC, but the optimal route and dose of FMT remain unanswered.
METHODS AND ANALYSIS
This prospective, multi-centre open-label, randomised pilot study will assess two possible routes of FMT delivery, via the nasogastric (NG) route or by delivery to the COLON, in 30 patients with active UC recruited from three sites in the UK. Stool will be collected from healthy screened donors, processed, frozen and stored under a Medicines and Healthcare products Regulatory Agency (MHRA) ""specials"" manufacturing licence held at the University of Birmingham Microbiome Treatment Centre. Thawed FMT samples will be administered to patients either via eight nasogastric infusions given initially over 4 days starting on the day of randomisation, and then again for 4 days in week 4 for foregut delivery (total of 240 g of stool) or via one colonoscopic infusion followed by seven weekly enemas according to the hindgut protocol (total of 360 g of stool). Patients will be followed up weekly for 8 weeks, and then at 12 weeks. The aims of this pilot study are (1) to determine which FMT administration route (NG or COLON) should be investigated in a randomised double-blind, placebo-controlled trial and (2) to determine if a full randomised controlled trial is feasible. The primary outcome will be a composite assessment of both qualitative and quantitative data based on efficacy (clinical response), acceptability and safety. At the end of the pilot study, decisions will be made regarding the feasibility of a full randomised double-blind, placebo-controlled trial and, if deemed feasible, which route of administration should be used in such a study.
ETHICS AND DISSEMINATION
Ethical approval for this study has been obtained from the East Midlands-Nottingham Research Ethics Committee (REC 17/EM/0274). At the end of the study, findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
ISRCTN74072945.",2019,"At the end of the pilot study, decisions will be made regarding the feasibility of a full randomised double-blind, placebo-controlled trial and, if deemed feasible, which route of administration should be used in such a study.
","['patients with ulcerative colitis', '30 patients with active UC recruited from three sites in the UK']","['faecal microbiota transplant delivery', 'placebo', 'FMT administration route (NG or COLON', 'FMT delivery, via the nasogastric (NG) route or by delivery to the COLON']","['composite assessment of both qualitative and quantitative data based on efficacy (clinical response), acceptability and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0694637', 'cui_str': 'Nasogastric use'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.362961,"At the end of the pilot study, decisions will be made regarding the feasibility of a full randomised double-blind, placebo-controlled trial and, if deemed feasible, which route of administration should be used in such a study.
","[{'ForeName': 'Mohammed Nabil Nabil', 'Initials': 'MNN', 'LastName': 'Quraishi', 'Affiliation': 'University of Birmingham Microbiome Treatment Centre, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Yalchin', 'Affiliation': 'Department of Gastroenterology, St Marks Hospital, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Blackwell', 'Affiliation': 'Gastroenterology Unit, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Segal', 'Affiliation': 'Department of Gastroenterology, St Marks Hospital, London, UK.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Gastroenterology, Heart of England NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hawkey', 'Affiliation': 'Institute of Microbiology and Infection, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'McCune', 'Affiliation': 'Institute of Microbiology and Infection, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ailsa L', 'Initials': 'AL', 'LastName': 'Hart', 'Affiliation': 'Department of Gastroenterology, St Marks Hospital, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaya', 'Affiliation': 'Gastroenterology Unit, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Ives', 'Affiliation': 'Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Magill', 'Affiliation': 'Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Shrushma', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Gerasimidis', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, Glasgow Royal Infirmary, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Nicholas James', 'Initials': 'NJ', 'LastName': 'Loman', 'Affiliation': 'Institute of Microbiology and Infection, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hansen', 'Affiliation': 'Department of Paediatric Gastroenterology, Royal Hospital for Children Glasgow, Glasgow, UK.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'McMullan', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mathers', 'Affiliation': 'Public Health, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Quince', 'Affiliation': 'Warwick Medical School, Microbiology and Infection, University of Warwick, Coventry, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Crees', 'Affiliation': ""Crohn's and Colitis UK, Saint Albans, UK.""}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Iqbal', 'Affiliation': 'University of Birmingham Microbiome Treatment Centre, University of Birmingham, Birmingham, UK t.h.iqbal@bham.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-030659']
213,31727650,Effectiveness-implementation hybrid type 2 trial evaluating two psychoeducational programmes for severe hypoglycaemia in type 1 diabetes: implementation study protocol.,"INTRODUCTION
Two of the most acute and feared complications in type 1 diabetes (T1D) are hypoglycaemia and severe hypoglycaemia (SH). While impaired awareness of hypoglycaemia (IAH) can lead to SH with cognitive and motivational barriers implicated, the available education does not integrate behavioural change techniques to address these. A novel Hypoglycaemia Awareness Restoration Programme despite optimised care (HARPdoc) is currently being tested against an established blood glucose awareness training (BGAT) within a parallel, two-arm, group randomised, blinded trial (with its own protocol; NCT02940873) with adults with T1D whose problems with hypoglycaemia and SH have persisted despite otherwise optimised insulin management. While both programmes are aimed at reducing hypoglycaemia, SH and IAH, it is the former that integrates behavioural change techniques.The aim of the current (implementation) study is to evaluate delivery of both HARPdoc and BGAT and explore associations between implementation outcomes and trial endpoints; as well as to develop an evidence-based implementation blueprint to guide implementation, sustainment and scale-up of the effective programmes.
METHODS AND ANALYSIS
Guided by the implementation science tools, frameworks, methods and principles, the current study was designed through a series of focus groups (n=11) with the key intervention stakeholders (n=28)-including (1) individuals with lived experience of T1D, IAH and a pilot version of the HARPdoc (n=6) and (2) diabetes healthcare professionals (n=22). A mixed-methods approach will be used throughout. Stakeholder engagement has underpinned study design and materials to maximise relevance, feasibility and impact.
ETHICS AND DISSEMINATION
The protocol has been reviewed and received ethical approval by the Harrow Research Ethics Committee (18/LO/1020; 240752) on 1 October 2018. The findings will be submitted to a peer-reviewed journal and presented at scientific meetings.
TRIAL REGISTRATION NUMBER
NCT02940873; Pre-results.",2019,"A novel Hypoglycaemia Awareness Restoration Programme despite optimised care (HARPdoc) is currently being tested against an established blood glucose awareness training (BGAT) within a parallel, two-arm, group randomised, blinded trial (with its own protocol; NCT02940873) with adults with T1D whose problems with hypoglycaemia and SH have persisted despite otherwise optimised insulin management.","['adults with T1D whose problems with hypoglycaemia and SH', 'groups (n=11) with the key intervention stakeholders (n=28)-including (1) individuals with lived experience of T1D, IAH and a pilot version of the HARPdoc (n=6) and (2) diabetes healthcare professionals (n=22', 'severe hypoglycaemia in type 1 diabetes']",['psychoeducational programmes'],"['hypoglycaemia, SH and IAH']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]",[],"[{'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",,0.0762183,"A novel Hypoglycaemia Awareness Restoration Programme despite optimised care (HARPdoc) is currently being tested against an established blood glucose awareness training (BGAT) within a parallel, two-arm, group randomised, blinded trial (with its own protocol; NCT02940873) with adults with T1D whose problems with hypoglycaemia and SH have persisted despite otherwise optimised insulin management.","[{'ForeName': 'Tayana', 'Initials': 'T', 'LastName': 'Soukup', 'Affiliation': ""Centre for Implementation Science, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK tayana.soukup@kcl.ac.uk.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hull', 'Affiliation': ""Centre for Implementation Science, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Emma Lauretta', 'Initials': 'EL', 'LastName': 'Smith', 'Affiliation': ""Department of Diabetes, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Healey', 'Affiliation': ""Centre for Implementation Science, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Bakolis', 'Affiliation': ""Centre for Implementation Science, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Amiel', 'Affiliation': ""Department of Diabetes, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Sevdalis', 'Affiliation': ""Centre for Implementation Science, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Department of Diabetes, King's College London, People With Diabetes (PWD) Group: Mr Mike Kendall, Ms Lis Warren, Ms Victoria Ruszala, Ms Mel Stephenson, Mr Arthur Durrant, London, UK.""}]",BMJ open,['10.1136/bmjopen-2019-030370']
214,31468503,Ulipristal acetate vs gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy (MYOMEX trial): Short-term results of a double-blind randomized controlled trial.,"INTRODUCTION
Laparoscopic myomectomy can be difficult when fibroids are large and numerous. This may result in extensive intraoperative bleeding and the need for a conversion to a laparotomy. Medical pretreatment prior to surgery might reduce these risks by decreasing fibroid size and vascularization of the fibroid. We compared pretreatment with ulipristal acetate (UPA) vs gonadotropin-releasing hormone agonists (GnRHa) prior to laparoscopic myomectomy on several intra- and postoperative outcomes.
MATERIAL AND METHODS
We performed a non-inferiority double-blind randomized controlled trial in nine hospitals in the Netherlands. Women were randomized between daily oral UPA for 12 weeks and single placebo injection or single intramuscular injection with leuprolide acetate and daily placebo tablets for 12 weeks. The primary outcome was intraoperative blood loss. Secondary outcomes were reduction of fibroid volume, suturing time, total surgery time and surgical ease.
RESULTS
Thirty women received UPA and 25 women leuprolide acetate. Non-inferiority of UPA regarding intraoperative blood loss was not demonstrated. When pretreated with UPA, median intraoperative blood loss was statistically significantly higher (525 mL [348-1025] vs 280 mL[100-500]; P = 0.011) and suturing time of the first fibroid was statistically significantly longer (40 minutes [28-48] vs 22 minutes [14-33]; P = 0.003) compared with GnRHa. Pretreatment with UPA showed smaller reduction in fibroid volume preoperatively compared with GnRHa (-7.2% [-35.5 to 54.1] vs -38.4% [-71.5 to -19.3]; P = 0.001). Laparoscopic myomectomies in women pretreated with UPA were subjectively judged more difficult than in women pretreated with GnRHa.
CONCLUSIONS
Non-inferiority of UPA in terms of intraoperative blood loss could not be established, possibly due to the preliminary termination of the study. Pretreatment with GnRHa was more favorable than UPA in terms of fibroid volume reduction, intraoperative blood loss, hemoglobin drop directly postoperatively, suturing time of the first fibroid and several subjective surgical ease parameters.",2020,"Laparoscopic myomectomies in women pre-treated with UPA were subjectively judged more difficult than in women pre-treated with GnRHa.
","['30 women received UPA and 25 women', 'nine hospitals in the Netherlands']","['UPA', 'placebo injection or single intramuscular injection with Leuprolide acetate and daily placebo tablets', 'Ulipristal acetate vs gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy', 'Laparoscopic myomectomy', 'Leuprolide acetate', 'daily oral UPA', 'ulipristal acetate (UPA) vs gonadotropin-releasing hormone agonists (GnRHa) prior to laparoscopic myomectomy']","['median intra-operative blood loss', 'reduction of fibroid volume, suturing time, total surgery time and surgical ease RESULTS', 'suturing time of the first fibroid', 'inferiority of UPA regarding intra-operative blood loss', 'Laparoscopic myomectomies', 'fibroid volume reduction, intra-operative blood loss, hemoglobin drop directly post-operatively, suturing time of the first fibroid and several subjective surgical ease parameters', 'intra-operative blood loss']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0296939', 'cui_str': 'UP(5)A'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0296939', 'cui_str': 'UP(5)A'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0700596', 'cui_str': 'Leuprolide Acetate'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C2723461', 'cui_str': 'ulipristal acetate'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C2111517', 'cui_str': 'Laparoscopic excision of uterine fibroid'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0296939', 'cui_str': 'UP(5)A'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",30.0,0.598359,"Laparoscopic myomectomies in women pre-treated with UPA were subjectively judged more difficult than in women pre-treated with GnRHa.
","[{'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'de Milliano', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, University Medical Center Amterdam, location VU Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith A F', 'Initials': 'JAF', 'LastName': 'Huirne', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, University Medical Center Amterdam, location VU Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Thurkow', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medical Center Amterdam, location Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Radder', 'Affiliation': 'Department of Obstetrics and Gynecology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Marlies Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynecology, Maxima Medical Center, Veldhoven, The Netherlands.'}, {'ForeName': 'Huib', 'Initials': 'H', 'LastName': 'van Vliet', 'Affiliation': 'Department of Obstetrics and Gynecology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'van de Lande', 'Affiliation': 'Department of Obstetrics and Gynecology, Spaarne Gasthuis, Haarlem, The Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Biostatistics, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Wouter J K', 'Initials': 'WJK', 'LastName': 'Hehenkamp', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, University Medical Center Amterdam, location VU Medical Center, Amsterdam, The Netherlands.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13713']
215,31031186,Reducing Radiation Dose and Improving Image Quality in CT Portal Venography Using 80 kV and Adaptive Statistical Iterative Reconstruction-V in Slender Patients.,"OBJECTIVE
To explore the feasibility of reducing radiation dose and improving image quality in CT portal venography (CTPV) using 80 kV and adaptive statistical iterative reconstruction-V(ASIR-V) in slender patients in comparison with conventional protocol using 120 kV and ASIR.
METHODS
Sixty slender patients for enhanced abdominal CT scanning were randomly divided into group A and group B. Group A used the conventional 120 kV tube voltage, 600 mgI/kg contrast dose and reconstructed with the recommended 40% ASIR. Group B used 80 kV tube voltage, 350 mgI/kg contrast dose and reconstructed with ASIR-V from 40% to 100% with 10% interval. The CT values and standard deviation (SD) values of the main portal vein, left branch, and right branch of portal vein, liver, and erector spinae at the same level were measured to calculate the signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR). The image quality was subjectively scored by two experienced radiologists blindly using a 5-point criterion. The contrast dose, volumetric CT dose index, and dose length product were recorded in both groups and the effective dose was calculated.
RESULTS
There was no significant difference in general data between the two groups (p > 0.05), the effective dose and contrast dose in group B were reduced by 63.3% (p < 0.001) and 39.7% (p < 0.001), respectively compared with group A. With the percentage of ASIR-V increased in group B, the CT values showed no significant difference, while the SD values gradually decreased and SNR values and CNR values increased accordingly. Compared with group A, group B demonstrated similar CT values (p > 0.05), while the SD values with 80% ASIR-V to 100% ASIR-V were significantly lower than those of 40% ASIR (p < 0.001), and the SNR values and CNR values with 70% ASIR-V to 100% ASIR-V were significantly higher than those of 40% ASIR (p < 0.001). The subjective image quality scores by the two radiologists had excellent consistency (kappa value>0.75, p < 0.001), and the final subjective image quality scores and the subjective scores in each of the 5 scoring categories with 60% ASIR-V to 100% ASIR-V were all significantly higher than those of 40% ASIR, and 80% ASIR-V obtained the highest subjective score among different reconstructions.
CONCLUSION
In CTPV, the application of 80 kV and ASIR-V reconstruction in slender patients can significantly reduce radiation dose (by 63.3%) and contrast agent dose (by 39.7%). Compared with the recommended 40% ASIR using 120 kV, ASIR-V with 80% to 100% percentages can further improve image quality and with 80% ASIR-V being the best reconstruction algorithm.
ADVANCES IN KNOWLEDGE
CTPV with 80 kV and ASIR-V algorithm in slender patients can significantly reduce radiation dose and contrast agent dose as well as improve image quality, compared with the conventional 120 kV protocol using 40% ASIR.",2020,"There was no significant difference in general data between the two groups (p > 0.05), the effective dose and contrast dose in group B were reduced by 63.3% (p < 0.001) and 39.7% (p < 0.001), respectively compared with group A.","['Sixty slender patients for enhanced abdominal CT scanning', 'slender patients in comparison with conventional protocol using 120 kV and ASIR', 'Slender Patients']","['CT portal venography (CTPV) using 80 kV and adaptive statistical iterative reconstruction-V(ASIR-V', 'conventional 120 kV tube voltage, 600 mgI/kg contrast dose and reconstructed with the recommended 40% ASIR']","['signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR', 'general data', 'SNR values and CNR values', 'image quality', 'CT values and standard deviation (SD) values of the main portal vein, left branch, and right branch of portal vein, liver, and erector spinae', 'percentage of ASIR-V', 'volumetric CT dose index, and dose length product', 'SD values', 'final subjective image quality scores and the subjective scores', 'subjective image quality scores', 'similar CT values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0031545', 'cui_str': 'Venography'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0032718', 'cui_str': 'Portal Vein'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205384', 'cui_str': 'Branching (qualifier value)'}, {'cui': 'C0226730', 'cui_str': 'Structure of right main branch of portal vein (body structure)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C1956110', 'cui_str': 'Cone-Beam Computerized Tomography'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.028019,"There was no significant difference in general data between the two groups (p > 0.05), the effective dose and contrast dose in group B were reduced by 63.3% (p < 0.001) and 39.7% (p < 0.001), respectively compared with group A.","[{'ForeName': 'Zhanli', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang 712000, Shaanxi, China; The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi, China.'}, {'ForeName': 'Xirong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang 712000, Shaanxi, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': ""Department of Medical Imaging of Chang'an Hospital, Xianyang, Shaanxi, China.""}, {'ForeName': 'Dou', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Medical Imaging of Chang'an Hospital, Xianyang, Shaanxi, China.""}, {'ForeName': 'Zhentang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Medical Imaging of Chang'an Hospital, Xianyang, Shaanxi, China.""}, {'ForeName': 'Donghong', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': ""Department of Medical Imaging of Chang'an Hospital, Xianyang, Shaanxi, China.""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang 712000, Shaanxi, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Yu', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang 712000, Shaanxi, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang 712000, Shaanxi, China.'}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang 712000, Shaanxi, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang 712000, Shaanxi, China.'}, {'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi, China.'}, {'ForeName': 'Zhanliang', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang 712000, Shaanxi, China.'}, {'ForeName': 'Taiping', 'Initials': 'T', 'LastName': 'He', 'Affiliation': 'Affiliated Hospital of Shaanxi University of Chinese Medicine, Weiyang western road- 2#, Xianyang 712000, Shaanxi, China. Electronic address: htp89956@163.com.'}]",Academic radiology,['10.1016/j.acra.2019.02.022']
216,31607205,Effects of Simvastatin on Augmentation Index Are Transient: Outcomes From a Randomized Controlled Trial.,"Background Statins improve endothelial function, but their effects on arterial stiffness and aortic blood pressure in middle-aged adults are uncertain. Methods and Results This was a prospective, randomized, double-blind, placebo-controlled trial of middle-aged (40-72 years old) adults who were randomly assigned to receive simvastatin 40 mg (n=44) or placebo (n=44) daily for 18 months to evaluate impact on dementia-related biomarkers (primary end points) and measures of vascular health (secondary end points). This analysis focuses on the predetermined secondary end points of changes in central aortic blood pressure, aortic augmentation index, and brachial artery flow-mediated dilation. Measurements were performed at baseline and after 6, 12, and 18 months. Multivariable models were used to identify predictors of these prespecified vascular end points. Study groups were similar at baseline; low-density lipoprotein cholesterol declined in the statin group but not in the placebo group ( P <0.01). There were no significant differences in changes in central blood pressure parameters or flow-mediated dilation (all P >0.2). After 12 months, augmentation index decreased from baseline in the statin group compared with the placebo group (-2.3% [5.5%] versus 1.2% [5.7%], P =0.007), but by 18 months the response in both groups trend toward baseline (-1.1% [5.8%] versus 0.2% [4.8%], P =0.3). Low-density lipoprotein cholesterol was not associated with changes in augmentation index at any time point. Conclusions Statin therapy led to a short-term reduction in augmentation index after 12 months, but this effect did not persist after 18 months despite continued reduction in low-density lipoprotein cholesterol levels. These findings suggest that statins may have a transient effect on aortic stiffness. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00939822.",2019,Study groups were similar at baseline; low-density lipoprotein cholesterol declined in the statin group but not in the placebo group ( P <0.01).,"['middle-aged adults', 'middle-aged (40-72\xa0years old) adults']","['placebo', 'simvastatin 40\xa0mg (n=44) or placebo', 'Simvastatin', ' Statins']","['Low-density lipoprotein cholesterol', 'central aortic blood pressure, aortic augmentation index, and brachial artery flow-mediated dilation', 'arterial stiffness and aortic blood pressure', 'low-density lipoprotein cholesterol', 'Augmentation Index Are Transient', 'central blood pressure parameters or flow-mediated dilation', 'low-density lipoprotein cholesterol levels', 'augmentation index', 'endothelial function']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0989916', 'cui_str': 'Simvastatin 40 MG'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0456180', 'cui_str': 'Aortic Blood Pressure'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.739562,Study groups were similar at baseline; low-density lipoprotein cholesterol declined in the statin group but not in the placebo group ( P <0.01).,"[{'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Gepner', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital Madison WI.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lazar', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital Madison WI.'}, {'ForeName': 'Carol Van', 'Initials': 'CV', 'LastName': 'Hulle', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital Madison WI.'}, {'ForeName': 'Claudia E', 'Initials': 'CE', 'LastName': 'Korcarz', 'Affiliation': 'Department of Medicine School of Medicine and Public Health University of Wisconsin Madison WI.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Asthana', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital Madison WI.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Carlsson', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital Madison WI.'}]",Journal of the American Heart Association,['10.1161/JAHA.118.009792']
217,31682266,Urinary Pharmacokinetic Profile of Cannabinoids Following Administration of Vaporized and Oral Cannabidiol and Vaporized CBD-Dominant Cannabis.,"Cannabis products in which cannabidiol (CBD) is the primary chemical constituent (CBD-dominant) are increasingly popular and widely available. The impact of CBD exposure on urine drug testing has not been well studied. This study characterized the urinary pharmacokinetic profile of 100-mg oral and vaporized CBD, vaporized CBD-dominant cannabis (100-mg CBD; 3.7-mg ∆9-THC) and placebo in healthy adults (n = 6) using a within-subjects crossover design. Urine specimens were collected before and for 5 days after drug administration. Immunoassay (IA) screening (cutoffs of 20, 50 and 100 ng/mL) and LC-MS-MS confirmatory tests (cutoff of 15 ng/mL) for 11-nor-9-carboxy-∆9-tetrahydrocannabinol (∆9-THCCOOH) were performed; urine was also analyzed for CBD and other cannabinoids. Urinary concentrations of CBD were higher after oral (mean Cmax: 776 ng/mL) versus vaporized CBD (mean Cmax: 261 ng/mL). CBD concentrations peaked 5 h after oral CBD ingestion and within 1 h after inhalation of vaporized CBD. After pure CBD administration, only 1 out of 218 urine specimens screened positive for ∆9-THCCOOH (20-ng/mL IA cutoff) and no specimens exceeded the 15-ng/mL confirmatory cutoff. After inhalation of CBD-dominant cannabis vapor, nine samples screened positive at the 20-ng/mL IA cutoff, and two of those samples screened positive at the 50-ng/mL IA cutoff. Four samples that screened positive (two at 20 ng/mL and two at 50 ng/mL) confirmed positive with concentrations of ∆9-THCCOOH exceeding 15 ng/mL. These data indicate that acute dosing of pure CBD will not result in a positive urine drug test using current federal workplace drug testing guidelines (50-ng/mL IA cutoff with 15-ng/mL confirmatory cutoff). However, CBD products that also contain ∆9-THC may produce positive urine results for ∆9-THCCOOH. Accurate labeling and regulation of ∆9-THC content in CBD/hemp products are needed to prevent unexpected positive drug tests and unintended drug effects.",2020,Urinary concentrations of CBD were higher after oral (mean Cmax: 776 ng/mL) versus vaporized CBD (mean Cmax: 261 ng/mL).,['healthy adults (n = 6'],"['placebo', 'vaporized CBD', '100-mg oral and vaporized CBD, vaporized CBD-dominant cannabis', 'Vaporized and Oral Cannabidiol and Vaporized CBD-Dominant Cannabis']","['CBD concentrations', 'Urinary concentrations of CBD']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration, function (observable entity)'}]",,0.252828,Urinary concentrations of CBD were higher after oral (mean Cmax: 776 ng/mL) versus vaporized CBD (mean Cmax: 261 ng/mL).,"[{'ForeName': 'Tory R', 'Initials': 'TR', 'LastName': 'Spindle', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD 21224, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Cone', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD 21224, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kuntz', 'Affiliation': 'Clinical Reference Laboratory, 8433 Quivira Rd, Lenexa, KS 66214, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Mitchell', 'Affiliation': 'RTI International, Research Triangle Park, 3040 East Cornwallis Rd., Durham, NC 27709, USA.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Bigelow', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD 21224, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Flegel', 'Affiliation': 'Substance Abuse and Mental Health Services Administration (SAMHSA), Division of Workplace Programs (DWP), 5600 Fishers Lane, Rockville, MD 20857, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD 21224, USA.'}]",Journal of analytical toxicology,['10.1093/jat/bkz080']
218,31772083,Study protocol for a randomised trial for atosiban versus placebo in threatened preterm birth: the APOSTEL 8 study.,"INTRODUCTION
Preterm birth complicates >15 million pregnancies annually worldwide. In many countries, women who present with signs of preterm labour are treated with tocolytics for 48 hours. Although this delays birth, it has never been shown to improve neonatal outcome. In 2015, the WHO stated that the use of tocolytics should be reconsidered and that large placebo-controlled studies to evaluate the effectiveness of tocolytics are urgently needed.
METHODS AND ANALYSIS
We designed an international, multicentre, randomised, double-blinded, placebo-controlled clinical trial. Women with threatened preterm birth (gestational age 30-34 weeks), defined as uterine contractions with (1) a cervical length of < 15 mm or (2) a cervical length of 15-30 mm and a positive fibronectin test or (3) in centres where cervical length measurement is not part of the local protocol: a positive fibronectin test or insulin-like growth factor binding protein-1 (Actim-Partus test) or (4) ruptured membranes, will be randomly allocated to treatment with atosiban or placebo for 48 hours. The primary outcome is a composite of perinatal mortality and severe neonatal morbidity. Analysis will be by intention to treat. A sample size of 1514 participants (757 per group) will detect a reduction in adverse neonatal outcome from 10% to 6% (alpha 0.05, beta 0.2). A cost-effectiveness analysis will be performed from a societal perspective.
ETHICS AND DISSEMINATION
This study has been approved by the Research Ethics Committee (REC) of the Amsterdam University Medical Centres, location AMC, as well as the REC's in Dublin and the UK. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results.
TRIAL REGISTRATION NUMBER
Nederlands Trial Register (Trial NL6469).",2019,"A sample size of 1514 participants (757 per group) will detect a reduction in adverse neonatal outcome from 10% to 6% (alpha 0.05, beta 0.2).","['Women with threatened preterm birth (gestational age 30-34 weeks), defined as uterine contractions with (1) a cervical length of < 15 mm or (2) a cervical length of 15-30 mm and a positive fibronectin test or (3) in centres where cervical length measurement is not part of the local protocol: a', 'threatened preterm birth']","['placebo', 'atosiban versus placebo', 'positive fibronectin test or insulin-like growth factor binding protein-1', 'atosiban or placebo']","['adverse neonatal outcome', 'composite of perinatal mortality and severe neonatal morbidity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0042130', 'cui_str': 'Myometrial Contraction'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0450396', 'cui_str': '30mm (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0016055', 'cui_str': 'Opsonic alpha(2)SB Glycoprotein'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1956055', 'cui_str': 'Cervical Length Measurement'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0164398', 'cui_str': 'Atosiban'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0016055', 'cui_str': 'Opsonic alpha(2)SB Glycoprotein'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0123256', 'cui_str': 'IGFBP-1'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",1514.0,0.743841,"A sample size of 1514 participants (757 per group) will detect a reduction in adverse neonatal outcome from 10% to 6% (alpha 0.05, beta 0.2).","[{'ForeName': 'Job', 'Initials': 'J', 'LastName': 'Klumper', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Breebaart', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Carolien', 'Initials': 'C', 'LastName': 'Roos', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Christiana A', 'Initials': 'CA', 'LastName': 'Naaktgeboren', 'Affiliation': 'University Medical Centre Utrecht, Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'van der Post', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'van Kaam', 'Affiliation': 'Department of Neonatology, Amsterdam UMC, Location AMC and VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Ewoud', 'Initials': 'E', 'LastName': 'Schuit', 'Affiliation': 'University Medical Centre Utrecht, Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jelle', 'Initials': 'J', 'LastName': 'Baalman', 'Affiliation': 'Department of Obstetrics and Gynaecology, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Fionnuala', 'Initials': 'F', 'LastName': 'McAuliffe', 'Affiliation': 'Department of Obstetrics and Gynaecology, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Thornton', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Kok', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Martijn A', 'Initials': 'MA', 'LastName': 'Oudijk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands m.a.oudijk@amsterdamumc.nl.'}]",BMJ open,['10.1136/bmjopen-2019-029101']
219,32295683,#CRCFREE: Using Social Media to Reduce Colorectal Cancer Risk in Rural Adults.,"Objectives: In this study, we pilot-tested #CRCFree, a Facebook-based intervention aimed at reducing colorectal cancer (CRC) risk in rural Appalachian adults at risk for CRC. Methods: Participants were 56 rural Appalachian adults aged > 50 years. Daily #CRCFree Facebook posts addressed diet, physical activity, and CRC screening. Participants' sociodemographics, diet, body mass index, physical activity, and CRC screening status were measured pre- and post-intervention. The Healthy Eating Index (HEI) and the Dietary Inflammatory Index (DII) assessed dietary patterns. Facebook engagement was measured throughout the intervention. A post-intervention focus group evaluated intervention acceptability. Results: Participants were Caucasian, aged 58 ± 6 years, and predominantly female (66%). Post-intervention, HEI scores increased (49.9 ± 9.9 vs 58.6 ± 12.1, p = <.001), and DII scores decreased from baseline (2.8 ± 1.1 vs 1.6 ± 1.7, p = .002). There was no change in physical activity, BMI, or CRC screening status. Focus group participants found the intervention to be educational and motivating. Conclusions: These results provide preliminary evidence to support using Facebook to address CRC risk in this population. Participants were responsive to this intervention, and Facebook is a novel and accessible modality for health promotion.",2020,"Post-intervention, HEI scores increased (49.9 ± 9.9 vs 58.6 ± 12.1, p = <.001), and DII scores decreased from baseline (2.8 ± 1.1 vs 1.6 ± 1.7, p = .002).","['Rural Adults', 'rural Appalachian adults at risk for CRC', 'Participants were 56 rural Appalachian adults aged > 50 years', 'Participants were Caucasian, aged 58 ± 6 years, and predominantly female (66']",['Social Media'],"['Facebook engagement', 'Healthy Eating Index (HEI) and the Dietary Inflammatory Index (DII) assessed dietary patterns', 'physical activity, BMI, or CRC screening status', ""Participants' sociodemographics, diet, body mass index, physical activity, and CRC screening status"", 'DII scores', 'HEI scores', 'colorectal cancer (CRC) risk']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C3179065', 'cui_str': 'Social Medium'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0421330', 'cui_str': 'Screening status'}, {'cui': 'C0385506', 'cui_str': 'didodecylindocarbocyanine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",56.0,0.0201364,"Post-intervention, HEI scores increased (49.9 ± 9.9 vs 58.6 ± 12.1, p = <.001), and DII scores decreased from baseline (2.8 ± 1.1 vs 1.6 ± 1.7, p = .002).","[{'ForeName': 'Kaitlin Voigts', 'Initials': 'KV', 'LastName': 'Key', 'Affiliation': 'Kaitlin Voigts Key, Doctoral Candidate, University of Kentucky College of Nursing, Lexington, KY;, Email: kaitlin.key@uky.edu.'}, {'ForeName': 'Adebola', 'Initials': 'A', 'LastName': 'Adegboyega', 'Affiliation': 'Adebola Adegboyega, Assistant Professor, University of Kentucky College of Nursing, Lexington, KY.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Bush', 'Affiliation': 'Heather Bush, Kate Spade & Co. Foundation Endowed Professor, Department of Biostatistics, University of Kentucky College of Public Health.'}, {'ForeName': 'Mollie E', 'Initials': 'ME', 'LastName': 'Aleshire', 'Affiliation': 'Mollie E. Aleshire, DNP Program Director/Associate Professor, University of North Carolina at Greensboro School of Nursing, Greensboro, NC.'}, {'ForeName': 'Omar A', 'Initials': 'OA', 'LastName': 'Contreras', 'Affiliation': 'Omar A. Contreras, Program Director of Policy and Translational Research, Office of Community Outreach and Engagement, The University of Arizona Cancer Center.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hatcher', 'Affiliation': 'Jennifer Hatcher, Professor, Mel & Enid Zuckerman College of Public Health, Associate Director for Community Outreach & Engagement, The University of Arizona Cancer Center.'}]",American journal of health behavior,['10.5993/AJHB.44.3.8']
220,32301407,"Effect of daily consumption of cranberry beverage on insulin sensitivity and modification of cardiovascular risk factors in adults with obesity: a pilot, randomised, placebo-controlled study.","Cranberries are high in polyphenols, and epidemiological studies have shown that a high-polyphenol diet may reduce risk factors for diabetes and CVD. The present study aimed to determine if short-term cranberry beverage consumption would improve insulin sensitivity and other cardiovascular risk factors. Thirty-five individuals with obesity and with elevated fasting glucose or impaired glucose tolerance participated in a randomised, double-blind, placebo-controlled, parallel-designed pilot trial. Participants consumed 450 ml of low-energy cranberry beverage or placebo daily for 8 weeks. Changes in insulin sensitivity and cardiovascular risk factors including vascular reactivity, blood pressure, RMR, glucose tolerance, lipid profiles and oxidative stress biomarkers were evaluated. Change in insulin sensitivity via hyperinsulinaemic-euglycaemic clamp was not different between the two groups. Levels of 8-isoprostane (biomarker of lipid peroxidation) decreased in the cranberry group but increased in the placebo group (-2·18 v. +20·81 pg/ml; P = 0·02). When stratified by baseline C-reactive protein (CRP) levels, participants with high CRP levels (>4 mg/l) benefited more from cranberry consumption. In this group, significant differences in the mean change from baseline between the cranberry (n 10) and the placebo groups (n 7) in levels of TAG (-13·75 v. +10·32 %; P = 0·04), nitrate (+3·26 v. -6·28 µmol/l; P = 0·02) and 8-isoprostane (+0·32 v. +30·8 pg/ml; P = 0·05) were observed. These findings indicate that 8 weeks of daily cranberry beverage consumption may not impact insulin sensitivity but may be helpful in lowering TAG and changing certain oxidative stress biomarkers in individuals with obesity and a proinflammatory state.",2020,"Levels of 8-isoprostane (biomarker of lipid peroxidation) decreased in the cranberry group but increased in the placebo group (-2.18 pg/mL vs +20.81 pg/mL, p=0.02).","['Thirty-five obese individuals with elevated fasting glucose or impaired glucose tolerance participated', 'Obese Adults', 'obese individuals with a proinflammatory state']","['low-calorie cranberry beverage or placebo', 'polyphenol diet', 'placebo', 'Daily Consumption of Cranberry Beverage', 'Placebo']","['Insulin Sensitivity and Modification of Cardiovascular Risk Factors', 'Levels of 8-isoprostane (biomarker of lipid peroxidation', 'insulin sensitivity via hyperinsulinemic euglycemic clamp', 'insulin sensitivity and cardiovascular risk factors including vascular reactivity, blood pressure, resting metabolic rate, glucose tolerance, lipid profiles, and oxidative stress biomarkers', 'insulin sensitivity and other cardiovascular risk factors', 'levels of triglyceride']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.644559,"Levels of 8-isoprostane (biomarker of lipid peroxidation) decreased in the cranberry group but increased in the placebo group (-2.18 pg/mL vs +20.81 pg/mL, p=0.02).","[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Hsia', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA70808, USA.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Zhang', 'Affiliation': 'Ocean Spray Cranberries, Inc., Lakeville-Middleboro, MA02349, USA.'}, {'ForeName': 'Robbie S', 'Initials': 'RS', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA70808, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA70808, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Khoo', 'Affiliation': 'Ocean Spray Cranberries, Inc., Lakeville-Middleboro, MA02349, USA.'}]",The British journal of nutrition,['10.1017/S0007114520001336']
221,32299120,Plantar stimulation alters brain connectivity in idiopathic Parkinson's disease.,"OBJECTIVE
Individuals with Parkinson's disease (PD) and freezing of gait (FOG) present peripheral and central sensitivity disturbances that impair motor performance. This study aimed to investigate long-term effects of plantar sensory stimulation on brain activity, brain connectivity, and gait velocity of individuals with PD and FOG.
METHODS
Twenty-five participants were enrolled in this clinical trial (NCT02594540). Plantar sensory stimulation was delivered using the Automated Mechanical Peripheral Stimulation therapy (AMPS). Volunteers were randomly assigned to real or placebo AMPS groups and received eight sessions of treatment. The primary outcome was brain activity (task-based fMRI-active ankle dorsi-plantar flexion). Secondary outcomes were brain connectivity (resting state-RS fMRI) and gait velocity. fMRI was investigated on the left, right, and mid-sensory motor regions, left and right basal ganglia.
RESULTS
No changes in brain activity were observed when task-based fMRI was analyzed. After real AMPS, RS functional connectivity between basal ganglia and sensory-related brain areas increased (insular and somatosensory cortices). Gait velocity also increased after real AMPS. A positive correlation was found between gait velocity and the increased connectivity between sensory, motor and supplementary motor cortices.
CONCLUSION
Plantar sensory stimulation through AMPS was not able to modify brain activity. AMPS increased the RS brain connectivity mainly in areas related to sensory processing and sensorimotor integration. Plantar stimulation could be a way to improve plantar sensitivity and consequently ameliorate gait performance. However, the mechanisms behind the way AMPS influences brain pathways are still not completely known.",2020,"After real AMPS, RS functional connectivity between basal ganglia and sensory-related brain areas increased (insular and somatosensory cortices).","['subjects with PD and FOG.\nMETHODS\n\n\nTwenty-five subjects', ""Individuals with Parkinson's Disease (PD) and freezing of gait (FOG"", ""idiopathic Parkinson's Disease""]","['AMPS', 'plantar sensory stimulation', 'placebo AMPS', 'Plantar stimulation', 'Plantar sensory stimulation was delivered using the Automated Mechanical Peripheral Stimulation therapy (AMPS']","['connectivity between sensory, motor and supplementary motor cortices', 'RS brain connectivity', 'brain activity, brain connectivity and gait velocity', 'brain activity (task-based fMRI - active ankle dorsi-plantar flexion', 'fMRI', 'RS functional connectivity between basal ganglia and sensory-related brain areas increased (insular and somatosensory cortices', 'brain activity', 'Gait velocity', 'brain connectivity (resting-state - RS fMRI) and gait velocity', 'gait velocity', 'plantar sensitivity and consequently ameliorate gait performance']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0150763', 'cui_str': 'Sensory stimulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0004781', 'cui_str': 'Basal ganglion structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",25.0,0.0374991,"After real AMPS, RS functional connectivity between basal ganglia and sensory-related brain areas increased (insular and somatosensory cortices).","[{'ForeName': 'Aline Souza', 'Initials': 'AS', 'LastName': 'Pagnussat', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Salazar', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Pinto', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Ritchele', 'Initials': 'R', 'LastName': 'Redivo Marchese', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Carlos R M', 'Initials': 'CRM', 'LastName': 'Rieder', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'José Osmar', 'Initials': 'JO', 'LastName': 'Alves Filho', 'Affiliation': 'Autism Center, Child Mind Institute, New York, NY, USA.'}, {'ForeName': 'Alexandre R', 'Initials': 'AR', 'LastName': 'Franco', 'Affiliation': 'Center for Biomedical Imaging and Neuromodulation, Nathan S. Kline Institute for Psychiatric Research, Orangeburg, NY, USA.'}, {'ForeName': 'Ana Francisca Rozin', 'Initials': 'AFR', 'LastName': 'Kleiner', 'Affiliation': 'Department of Physiotherapy, Universidade Federal de São Carlos (UFSCAR), São Carlos, Brazil.'}]",Acta neurologica Scandinavica,['10.1111/ane.13253']
222,31780586,"Design of a randomised controlled trial of the effects of empagliflozin on myocardial perfusion, function and metabolism in type 2 diabetes patients at high cardiovascular risk (the SIMPLE trial).","INTRODUCTION
A diagnosis of type 2 diabetes (T2D) more than doubles the risk of cardiovascular disease (CVD), with heart failure (HF) being one of the most common complications with a severe prognosis. The landmark Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Paitients (EMPA-REG OUTCOME) study demonstrated that treatment with the sodium glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin rapidly and significantly reduces CVD mortality and admission rates for HF. However, the mechanisms behind this reduction in clinical events are unknown.This study was designed to investigate the effects of the SGLT-2 inhibitor empagliflozin on myocardial perfusion and function in patients with T2D and high CVD risk.
METHODS AND ANALYSIS
In this investigator-initiated, randomised, double-blind controlled clinical trial, 92 patients with T2D and established CVD or high CVD risk will be randomised to treatment with empagliflozin 25 mg or a matching placebo for 13 weeks. The primary outcome measure is change in myocardial flow reserve measured quantitatively by Rubidium-82 position emission tomography. In a substudy, invasive haemodynamics at rest and during exercise will be measured at baseline and following the intervention, using right heart catheterisation.
ETHICS AND DISSEMINATION
The study protocol (v7, 02/08/2018) has been approved by the Ethics Committee of the Capital Region, Danish Data Protection Board and the Danish Medicines Agency, and it will be monitored according to the Good Clinical Practice regulations from the International Conference on Harmonization. The results be submitted to international peer-reviewed journals and be presented at conferences. The data will be made available to the public via EudraCT and www.clinicaltrials.gov.
TRIAL REGISTRATION NUMBER
NCT03151343.",2019,"This study was designed to investigate the effects of the SGLT-2 inhibitor empagliflozin on myocardial perfusion and function in patients with T2D and high CVD risk.
","['type 2 diabetes patients at high cardiovascular risk (the SIMPLE trial', 'patients with T2D and high CVD risk', '92 patients with T2D and established CVD or high CVD risk']","['empagliflozin 25\u2009mg or a matching placebo', 'sodium glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin', 'empagliflozin', 'SGLT-2 inhibitor empagliflozin']","['change in myocardial flow reserve measured quantitatively by Rubidium-82 position emission tomography', 'CVD mortality and admission rates', 'myocardial perfusion and function', 'myocardial perfusion, function and metabolism']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}]","[{'cui': 'C3848929', 'cui_str': 'empagliflozin 25 MG'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0303554', 'cui_str': 'rubidium cation RB-82'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0233929', 'cui_str': 'Emission (finding)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",92.0,0.328312,"This study was designed to investigate the effects of the SGLT-2 inhibitor empagliflozin on myocardial perfusion and function in patients with T2D and high CVD risk.
","[{'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Jürgens', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Hasbak', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine & PET 4011, Cluster of Molecular Imaging, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kjær', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine & PET 4011, Cluster of Molecular Imaging, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Wolsk', 'Affiliation': 'Department of Cardiology-The Heart Centre, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zerahn', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Wiberg', 'Affiliation': 'Department of Medicine, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Niels Høgh', 'Initials': 'NH', 'LastName': 'Brandt', 'Affiliation': 'Department of Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Peter Haulund', 'Initials': 'PH', 'LastName': 'Gæde', 'Affiliation': 'Department of Cardiology and Endocrinology, Slagelse Hospital, Slagelse, Sjaelland, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center AS, Gentofte, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Medicine, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Inzucchi', 'Affiliation': 'Department of Endocrinology, Yale Shool of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology-The Heart Centre, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Caroline Michaela', 'Initials': 'CM', 'LastName': 'Kistorp', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark caroline.michaela.kistorp@regionh.dk.'}]",BMJ open,['10.1136/bmjopen-2019-029098']
223,31574339,Impact of multiplex respiratory virus testing on antimicrobial consumption in adults in acute care: a randomized clinical trial.,"OBJECTIVES
Inappropriate use of antibiotics is associated with development of antimicrobial resistance. In respiratory infections it is often difficult to differentiate between viral and bacterial infections, and empirical treatment is common. Enhanced viral testing is expected to clarify clinical decision-making and reduce the prescription of antibacterial agents, but the impact of such information on patient care is unclear.
METHODS
We conducted a (1:1) randomized controlled clinical trial involving 998 adults with respiratory symptoms, fever, chest pain or poor general condition in the emergency unit of a tertiary hospital. Multiplex PCR results for 496 patients were available in 24 hours (intervention group) and those for the remaining 502 patients were available in 7 days (control group). Our primary outcome measures were the duration of hospitalization and the consumption of antibiotics within 30 days of enrolment.
RESULTS
In all, 841 of 998 (84%) patients had respiratory symptoms at study entry. A respiratory virus was detected in 175 (17.5%). The mean duration of hospitalization was 4.2 days (SD 5.4) in the intervention group and 4.1 days (SD 4.9) in the control group (difference 0.1, 95% CI -0.5 to 0.6, p 0.810). The mean days on antibiotics were 11.3 days (SD 12.6) in the intervention group and 10.4 days (SD 11.4) in the control group (difference 0.9, 95% CI -0.6 to 2.4, p 0.235).
CONCLUSIONS
Multiplex PCR testing for respiratory viruses with results available within 24 hours did not reduce the consumption of bacterial antibiotics or the length of hospital stay in adults presenting with respiratory symptoms, fever, chest pain or reduced general condition in acute care.",2020,"CONCLUSIONS
Multiplex PCR testing for respiratory viruses with results available within 24 hours did not reduce the consumption of bacterial antibiotics or the length of hospital stay in adults presenting with respiratory symptoms, fever, chest pain or reduced general condition in acute care.","['adults in acute care', '998 adults with respiratory symptoms, fever, chest pain or poor general condition in the emergency unit of a tertiary hospital', '496 patients were available in 24\xa0hours (intervention group) and those for the remaining 502 patients in 7\xa0days (control group', '175 patients (17.5']",['multiplex respiratory virus testing'],"['duration of hospitalization and the consumption of antibiotics within 30\xa0days of enrollment', 'respiratory symptoms', 'consumption of bacterial antibiotics or the length of hospital stay', 'antimicrobial consumption', 'mean days on antibiotics', 'mean duration of hospitalization']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C0597404', 'cui_str': 'Respiratory viruses'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",998.0,0.166331,"CONCLUSIONS
Multiplex PCR testing for respiratory viruses with results available within 24 hours did not reduce the consumption of bacterial antibiotics or the length of hospital stay in adults presenting with respiratory symptoms, fever, chest pain or reduced general condition in acute care.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Saarela', 'Affiliation': 'Research Unit of Internal Medicine, Oulu University Hospital and University of Oulu, Finland. Electronic address: elina.saarela@oulu.fi.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tapiainen', 'Affiliation': 'PEDEGO Research Unit, University of Oulu, Finland; Department of Pediatrics and Adolescence, Oulu University Hospital, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kauppila', 'Affiliation': 'Seinäjoki Central Hospital, Seinäjoki, Finland; Nordlab, Oulu, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pokka', 'Affiliation': 'PEDEGO Research Unit, University of Oulu, Finland; Department of Pediatrics and Adolescence, Oulu University Hospital, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Uhari', 'Affiliation': 'PEDEGO Research Unit, University of Oulu, Finland; Department of Pediatrics and Adolescence, Oulu University Hospital, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kauma', 'Affiliation': 'Research Unit of Internal Medicine, Oulu University Hospital and University of Oulu, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Renko', 'Affiliation': 'PEDEGO Research Unit, University of Oulu, Finland; Department of Pediatrics and Adolescence, Oulu University Hospital, Finland.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2019.09.013']
224,32299898,Can autonomy support have an effect on type 2 diabetes glycemic control? Results of a cluster randomized controlled trial.,"OBJECTIVES
To assess whether social support or autonomy support intervention for patients with type 2 diabetes can achieve glycemic control at the end of intervention, and to test whether the glycemic control effect can be maintained for a long time.
RESEARCH DESIGN AND METHODS
In this cluster randomized controlled trial, 18 community healthcare stations (CHSs) were randomized to the following: (1) usual care group (UCG) offering regular public health management services, (2) social support group (SSG) providing 3-month social support intervention based on problem solving principles, and (3) autonomy support group (ASG) offering 3-month autonomy support intervention based on self-determination theory. A total of 364 patients registered in the CHSs were enrolled into either of the three groups. The primary outcome was hemoglobin A1c (HbA1c), and secondary outcomes were diabetes self-management (DSM) behaviors. Assessment was conducted at baseline and at 3 and 6 months.
RESULTS
Patients in ASG achieved better HbA1c reduction at the end of intervention (0.53% or 7.23 mmol/mol, p < 0.001) than those in the UCG and successfully maintained it up to 6 months (0.42% or 5.41 mmol/mol, p < 0.001). However, patients in SSG did not experience significant change in HbA1c at 3 or 6 months when compared with patients in UCG. Besides, patients in both the SSG (0.12, p < 0.05) and ASG (0.22, p < 0.001) experienced improvement in exercise at 3 months. Patients in ASG sustained improvement in exercise up to 6 months (0.21, p<0.001), but those in the SSG did not.
CONCLUSIONS
Autonomy support for patients with type 2 diabetes could help achieve glycemic control at the end of intervention and successfully maintain it up to 6 months. These findings indicate that autonomy support has positive long-term effects on DSM behaviors and glycemic control and can be recommended in future diabetes intervention programs.
TRIAL REGISTRATION NUMBER
ChiCTR1900024354.",2020,"Patients in ASG sustained improvement in exercise up to 6 months (0.21, p<0.001), but those in the SSG did not.
","['18 community healthcare stations (CHSs', '364 patients registered in the CHSs were enrolled into either of the three groups', 'patients with type 2 diabetes']","['usual care group (UCG) offering regular public health management services, (2) social support group (SSG) providing 3-month social support intervention based on problem solving principles, and (3) autonomy support group (ASG) offering 3-month autonomy support intervention based on self-determination theory', 'social support or autonomy support intervention']","['ASG', 'hemoglobin A1c (HbA1c), and secondary outcomes were diabetes self-management (DSM) behaviors', 'HbA1c reduction', 'ASG sustained improvement in exercise']","[{'cui': 'C0086034', 'cui_str': 'Community Healthcare'}, {'cui': 'C0585825', 'cui_str': 'Patient registered'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}]","[{'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",18.0,0.0438535,"Patients in ASG sustained improvement in exercise up to 6 months (0.21, p<0.001), but those in the SSG did not.
","[{'ForeName': 'Qingping', 'Initials': 'Q', 'LastName': 'Yun', 'Affiliation': 'School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Shenglan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Xuewen', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Jingnan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'School of Public Health, Peking University, Beijing, China changchunpku@126.com.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-001018']
225,31712331,Neurosurgical enhanced recovery after surgery (ERAS) programme for elective craniotomies: are patients satisfied with their experiences? A quantitative and qualitative analysis.,"OBJECTIVE
To evaluate patient satisfaction and associated predictors at discharge, as well as patient experience at 30-day follow-up, in a neurosurgical enhanced recovery after surgery (ERAS) programme.
DESIGN
A single-centre, prospective, randomised controlled study.
SETTING
A tertiary hospital in China.
PARTICIPANTS
A total of 140 neurosurgical patients aged 18-65 years old who had a single intracranial lesion and were admitted for elective craniotomy between October 2016 and July 2017 were included.
INTERVENTIONS
Patients were randomised into two groups: 70 patients received care according to a novel neurosurgical ERAS protocol (ERAS group) and 70 patients received conventional perioperative care (control group).
OUTCOME MEASURES
Patient satisfaction at discharge was evaluated using a multimodal questionnaire. A secondary analysis of patient experience regarding participation in the ERAS programme was conducted using a semistructured qualitative interview via telephone at 30-day follow-up.
RESULTS
The mean patient satisfaction was significantly higher in the ERAS group than in the control group at discharge (92.2±4.3 vs 86.8±7.4, p=0.0001). The most important predictors of patient satisfaction included age (OR=6.934), postoperative nausea and vomiting (PONV) Visual Analogue Scale (VAS) score (OR=0.184), absorbable skin suture (OR=0.007) and postoperative length of stay (LOS) (OR=0.765). Analysis on patient experience revealed five themes: information transfer, professional support, shared responsibility and active participation, readiness for discharge, and follow-up, all of which are closely related and represent positive and negative aspects.
CONCLUSIONS
Measures that include decreasing PONV VAS score, incorporating absorbable skin suture and shortening LOS seem to increase patient satisfaction in a neurosurgical ERAS programme. Analysis of data on patient experience highlights several aspects to achieve patient-centred and high-quality care. Further studies are warranted to standardise the assessment of patient satisfaction and experience in planning, employing and appraising the ERAS programme.
TRIAL REGISTRATION NUMBER
ChiCTR-INR-16009662.",2019,"Visual Analogue Scale (VAS) score (OR=0.184), absorbable skin suture (OR=0.007) and postoperative length of stay (LOS) (OR=0.765).","['A total of 140 neurosurgical patients aged 18-65 years old who had a single intracranial lesion and were admitted for elective craniotomy between October 2016 and July 2017 were included', 'A tertiary hospital in China', 'elective craniotomies']","['care according to a novel neurosurgical ERAS protocol (ERAS group) and 70 patients received conventional perioperative care (control group', 'Neurosurgical enhanced recovery after surgery (ERAS) programme', 'ERAS']","['PONV VAS score', 'absorbable skin suture', 'postoperative length of stay (LOS', 'postoperative nausea and vomiting (PONV', 'Visual Analogue Scale (VAS) score', 'mean patient satisfaction']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0150706', 'cui_str': 'Perioperative Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",2017.0,0.0753777,"Visual Analogue Scale (VAS) score (OR=0.184), absorbable skin suture (OR=0.007) and postoperative length of stay (LOS) (OR=0.765).","[{'ForeName': 'Bolin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, China.""}, {'ForeName': 'Shujuan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics and Gynecology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Binfang', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Tianzhi', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Lanfu', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wenhai', 'Initials': 'W', 'LastName': 'Lv', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yufu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, China.""}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yingxi', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Qu', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Shiming', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, China neurosurg@126.com,he-shiming@163.com.""}]",BMJ open,['10.1136/bmjopen-2018-028706']
226,32294534,Reducing Missed Opportunities for Human Papillomavirus Vaccination in School-Based Health Centers: Impact of an Intervention.,"OBJECTIVE
Human papillomavirus (HPV) immunization rates among US adolescents are low. Missed opportunities (MOs) for HPV vaccination are common. School-based health centers (SBHCs) have potential to boost HPV vaccination, but their role in addressing MOs has not been examined.
METHODS
We implemented a multicomponent intervention, consisting of 3 immunization process workflow modifications combined with provider performance feedback, in 2 Los Angeles area SBHCs and conducted a pre/post evaluation of MOs. Our primary outcome was SBHC-based MOs for HPV vaccination during all visits, including visits for confidential reproductive health care (ie, confidential visits). Secondary outcomes were MOs for meningococcal (MenACWY) and influenza vaccination during visits for nonconfidential care.
RESULTS
MOs for HPV vaccination decreased during all visit types from the baseline to the intervention period (82.3% to 46.1%; adjusted risk ratio [RR] = 0.558, P < .0001). The rate decrease appeared to be greater during physical examination visits than confidential visits (83.4% to 31.6% vs 98.7% to 70.4%, respectively). MOs for MenACWY (74.5% to 35.0%; adjusted RR = 0.47, P < .0001) and influenza (86.7% to 69.3%; adjusted RR = 0.792, P < .0001) vaccination also decreased during nonconfidential visits. Vaccine refusal was the most frequently documented reason for HPV vaccine MOs during both physical examination and confidential visits.
CONCLUSIONS
A pragmatic, multicomponent SBHC intervention reduced MOs for HPV vaccination during all visit types. MOs for MenACWY and influenza vaccination also decreased during nonconfidential visits. Findings suggest that practice-level improvements in SBHCs can improve delivery of HPV and other adolescent vaccines.",2020,"The rate decrease appeared to be greater during physical examination visits than confidential visits (83.4% to 31.6% vs. 98.7% to 70.4%, respectively).",['Human Papillomavirus Vaccination in School-Based Health Centers'],[],"['MOs for MenACWY and influenza vaccination', 'MOs for HPV vaccination', 'MOs for meningococcal (MenACWY) and influenza vaccination during visits for non-confidential care', 'HPV vaccination', 'SBHC-based MOs for HPV vaccination during all visits, including visits for confidential reproductive health care (i.e., confidential visits']","[{'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]",[],"[{'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}]",,0.0638702,"The rate decrease appeared to be greater during physical examination visits than confidential visits (83.4% to 31.6% vs. 98.7% to 70.4%, respectively).","[{'ForeName': 'Megha D', 'Initials': 'MD', 'LastName': 'Shah', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, David Geffen School of Medicine and UCLA Mattel Children's Hospital (University of California, Los Angeles) (MD Shah, PJ Chung, R Valderrama, and PG Szilagyi), Los Angeles, Calif. Electronic address: mshah@ph.lacounty.gov.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Glenn', 'Affiliation': 'UCLA Kaiser Permanente Center for Health Equity (BA Glenn and LC Chang), Los Angeles, Calif; Jonsson Comprehensive Cancer Center at UCLA (BA Glenn and LC Chang), Los Angeles, Calif; Department of Health Policy and Management, UCLA Fielding School of Public Health (BA Glenn), Los Angeles, Calif.'}, {'ForeName': 'L Cindy', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'UCLA Kaiser Permanente Center for Health Equity (BA Glenn and LC Chang), Los Angeles, Calif; Jonsson Comprehensive Cancer Center at UCLA (BA Glenn and LC Chang), Los Angeles, Calif.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Chung', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, David Geffen School of Medicine and UCLA Mattel Children's Hospital (University of California, Los Angeles) (MD Shah, PJ Chung, R Valderrama, and PG Szilagyi), Los Angeles, Calif.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Valderrama', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, David Geffen School of Medicine and UCLA Mattel Children's Hospital (University of California, Los Angeles) (MD Shah, PJ Chung, R Valderrama, and PG Szilagyi), Los Angeles, Calif.""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Uyeda', 'Affiliation': 'Los Angeles Unified School District (K Uyeda), Los Angeles, Calif. Dr Shah is now with the Los Angeles County Department of Public Health, Office of Health Assessment and Epidemiology, Los Angeles, Calif. Dr Chung is now with the Department of Health Systems Science, Kaiser Permanente School of Medicine, Pasadena, Calif. Dr Uyeda is now with the California School-Based Health Alliance, Oakland, Calif.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Szilagyi', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, David Geffen School of Medicine and UCLA Mattel Children's Hospital (University of California, Los Angeles) (MD Shah, PJ Chung, R Valderrama, and PG Szilagyi), Los Angeles, Calif.""}]",Academic pediatrics,['10.1016/j.acap.2020.04.002']
227,32272886,Impact of superimposed nephrological care to guidelines-directed management by primary care physicians of patients with stable chronic kidney disease: a randomized controlled trial.,"BACKGROUND
Optimal clinical care of patients with chronic kidney disease (CKD) requires collaboration between primary care physicians (PCPs) and nephrologists. We undertook a randomised trial to determine the impact of superimposed nephrologist care compared to guidelines-directed management by PCPs in CKD patients after hospital discharge.
METHODS
Stage 3b-4 CKD patients were enrolled during a hospitalization and randomised in two arms: Co-management by PCPs and nephrologists (interventional arm) versus management by PCPs with written instructions and consultations by nephrologists on demand (standard care). Our primary outcome was death or rehospitalisation within the 2 years post-randomisation. Secondary outcomes were: urgent renal replacement therapy (RRT), decline of renal function and decrease of quality of life at 2 years.
RESULTS
From November 2009 to the end of June 2013, we randomised 242 patients. Mean follow-up was 51 + 20 months. Survival without rehospitalisation, GFR decline and elective dialysis initiation did not differ between the two arms. Quality of life was also similar in both groups. Compared to randomised patients, those who either declined to participate in the study or were previously known by nephrologists had a worse survival.
CONCLUSION
These results do not demonstrate a benefit of a regular renal care compared to guided PCPs care in terms of survival or dialysis initiation in CKD patients. Increased awareness of renal disease management among PCPs may be as effective as a co-management by PCPs and nephrologists in order to improve the prognosis of moderate-to-severe CKD.
TRIAL REGISTRATION
This study was registered on June 29, 2009 in clinicaltrials.gov (NCT00929760) and adheres to CONSORT 2010 guidelines.",2020,These results do not demonstrate a benefit of a regular renal care compared to guided PCPs care in terms of survival or dialysis initiation in CKD patients.,"['CKD patients', 'patients with chronic kidney disease (CKD', 'From November 2009 to the end of June 2013, we randomised 242 patients', 'Stage 3b-4 CKD patients were enrolled during a hospitalization and randomised in two arms', 'CKD patients after hospital discharge', 'patients with stable chronic kidney disease']","['superimposed nephrological care to guidelines-directed management', 'Co-management by PCPs and nephrologists (interventional arm) versus management by PCPs with written instructions and consultations by nephrologists on demand (standard care', 'superimposed nephrologist care']","['survival or dialysis initiation', 'Survival without rehospitalisation, GFR decline and elective dialysis initiation', 'urgent renal replacement therapy (RRT), decline of renal function and decrease of quality of life at 2\u2009years', 'death or rehospitalisation', 'Quality of life', 'worse survival']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0260039', 'cui_str': 'Nephrologist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",,0.127699,These results do not demonstrate a benefit of a regular renal care compared to guided PCPs care in terms of survival or dialysis initiation in CKD patients.,"[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Saudan', 'Affiliation': 'Nephrology Unit, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland. Patrick.Saudan@hcuge.ch.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Ponte', 'Affiliation': 'Nephrology Unit, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Marangon', 'Affiliation': 'Nephrology Unit, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Martinez', 'Affiliation': 'Nephrology Unit, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Berchtold', 'Affiliation': 'Nephrology Unit, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jaques', 'Affiliation': 'Nephrology Unit, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ernandez', 'Affiliation': 'Nephrology Unit, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'de Seigneux', 'Affiliation': 'Nephrology Unit, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Carballo', 'Affiliation': 'Service of General Internal Medicine, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Perneger', 'Affiliation': 'Division of Clinical Epidemiology, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Martin', 'Affiliation': 'Nephrology Unit, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland.'}]",BMC nephrology,['10.1186/s12882-020-01747-3']
228,32229581,Antidopaminergic treatment is associated with reduced chorea and irritability but impaired cognition in Huntington's disease (Enroll-HD).,"OBJECTIVES
Alterations in dopamine neurotransmission underlie some of the clinical features of Huntington's disease (HD) and as such are a target for therapeutic intervention, especially for the treatment of chorea and some behavioural problems. However, justification for such an intervention is mainly based on case reports and small open label studies and the effects these drugs have on cognition in HD remain unclear.
METHODS
In this study, we used the Enroll-HD observational database to assess the effects of antidopaminergic medication on motor, psychiatric and cognitive decline, over a 3-year period. We first looked at the annual rate of decline of a group of HD patients taking antidopaminergic medication (n=466) compared with an untreated matched group (n=466). The groups were matched on specified clinical variables using propensity score matching. Next, we studied a separate group of HD patients who were prescribed such medications part way through the study (n=90) and compared their rate of change before and after the drugs were introduced and compared this to a matched control group.
RESULTS
We found that HD patients taking antidopaminergic medication had a slower progression in chorea and irritability compared with those not taking such medications. However, this same group of patients also displayed significantly greater rate of decline in a range of cognitive tasks.
CONCLUSION
In conclusion we found that antidopaminergic treatment is associated with improvements in the choreic movements and irritability of HD but worsens cognition. However, further research is required to prospectively investigate this and whether these are causally linked, ideally in a double-blind placebo-controlled trial.",2020,In conclusion we found that antidopaminergic treatment is associated with improvements in the choreic movements and irritability of HD but worsens cognition.,"['HD patients taking antidopaminergic medication (n=466) compared with an untreated matched group (n=466', 'HD patients who were prescribed such medications part way through the study (n=90']","['antidopaminergic medication', 'Antidopaminergic']","['chorea and irritability', 'choreic movements and irritability of HD but worsens cognition', 'motor, psychiatric and cognitive decline']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0008489', 'cui_str': 'Choreatic Syndromes'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}]",,0.0291193,In conclusion we found that antidopaminergic treatment is associated with improvements in the choreic movements and irritability of HD but worsens cognition.,"[{'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Harris', 'Affiliation': 'Department of Clinical Neurosciences, The University of Cambridge, Cambridge, United Kingdom kh600@cam.ac.uk.'}, {'ForeName': 'Wei-Li', 'Initials': 'WL', 'LastName': 'Kuan', 'Affiliation': 'Department of Clinical Neurosciences, The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Mason', 'Affiliation': 'Department of Clinical Neurosciences, Cambridge Centre for Brain Repair, Cambridge, Cambridgeshire, United Kingdom.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Barker', 'Affiliation': 'Department of Clinical Neurosciences, John van Geest Centre for Brain Repair, and MRC-WT Cambridge Stem Cell Institute, University of Cambridge, Cambridge, United Kingdom.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2019-322038']
229,32293992,Clinical Effectiveness of Single Pigtail Suture Stent on Patient Comfort: A Double-Blind Prospective Randomized Trial.,"Background: A double-pigtail ureteral stent (DPUS) can cause untoward symptoms, such as urgency, frequency, urinary incontinence, hematuria, and body pain that are bothersome to patient's quality of life (QoL). By reducing the quantity of material in the bladder, it could be reasonable to decrease stent-related symptoms (SRSs). We aimed to evaluate the tolerability of single pigtail suture stent (SPSS) with a validated questionnaire after uncomplicated retrograde semirigid ureteroscopic lithotripsy (URSL). Materials and Methods : A total of 130 patients who underwent ureteral stent placement after URSL for unilateral symptomatic ureteral stones with <15 mm diameter were randomized prospectively into two groups. Polyurethane ureteral stent (6 Fr, 24 or 26 cm) was placed in all patients, which was removed postoperatively with a mean of 14 days. There were 65 patients in both groups. All subjects completed the ureteral stent symptoms questionnaire (USSQ), which explores the SRSs. The questionnaires were conducted on the day of stent removal (at week 2) with the stent in situ and 4 weeks after removal (at week 6, poststent). The severity of SRSs and QoL were compared between the two groups. Results: SPSS was associated with perfect effect on all domains of USSQ, except from sexual and general health index scores. Pain index scores, visual analog scores (VAS), and analgesic requirements in SPSS group were found significantly low compared with those in the DPUS group. The QoL scores were significantly better in patients indwelling SPSS. Conclusion: SPSS is a potentially beneficial option to minimize ureteral SRSs after uncomplicated URSL.",2020,"Results: SPSS was associated with perfect effect on all domains of USSQ, except from sexual and general health index scores.","['Patient Comfort', 'for unilateral symptomatic ureteral stones with <15\u2009mm diameter', '130 patients who underwent']","['double-pigtail ureteral stent (DPUS', 'ureteral stent placement after URSL', 'single pigtail suture stent (SPSS', 'Materials and Methods ', 'retrograde semirigid ureteroscopic lithotripsy (URSL', 'Polyurethane ureteral stent', 'Single Pigtail Suture Stent']","['sexual and general health index scores', 'QoL scores', 'Pain index scores, visual analog scores (VAS), and analgesic requirements', 'severity of SRSs and QoL', 'ureteral stent symptoms questionnaire (USSQ']","[{'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0032616', 'cui_str': 'Polyisocyanate'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",130.0,0.0975918,"Results: SPSS was associated with perfect effect on all domains of USSQ, except from sexual and general health index scores.","[{'ForeName': 'Yakup', 'Initials': 'Y', 'LastName': 'Bostanci', 'Affiliation': 'Department of Urology, Faculty of Medicine, Ondokuz Mayis University, Samsun, Turkey.'}, {'ForeName': 'Mehmet Necmettin', 'Initials': 'MN', 'LastName': 'Mercimek', 'Affiliation': 'Clinic of Urology, Samsun Liv Hospital, Samsun, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Gulsen', 'Affiliation': 'Department of Urology, Faculty of Medicine, Ondokuz Mayis University, Samsun, Turkey.'}, {'ForeName': 'Ender', 'Initials': 'E', 'LastName': 'Ozden', 'Affiliation': 'Department of Urology, Faculty of Medicine, Ondokuz Mayis University, Samsun, Turkey.'}, {'ForeName': 'Yarkin Kamil', 'Initials': 'YK', 'LastName': 'Yakupoglu', 'Affiliation': 'Department of Urology, Faculty of Medicine, Ondokuz Mayis University, Samsun, Turkey.'}, {'ForeName': 'Saban', 'Initials': 'S', 'LastName': 'Sarikaya', 'Affiliation': 'Department of Urology, Faculty of Medicine, Ondokuz Mayis University, Samsun, Turkey.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2020.0127']
230,32132224,Effect of fingolimod on MRI outcomes in patients with paediatric-onset multiple sclerosis: results from the phase 3 PARADIG MS study.,"OBJECTIVE
PARADIG MS demonstrated superior efficacy and comparable safety of fingolimod versus interferon β-1a (IFN β-1a) in paediatric-onset multiple sclerosis (PoMS). This study aimed to report all predefined MRI outcomes from this study.
METHODS
Patients with multiple sclerosis (MS) (aged 10-<18 years) were randomised to once-daily oral fingolimod (n=107) or once-weekly intramuscular IFN β-1a (n=108) in this flexible duration study. MRI was performed at baseline and every 6 months for up to 2 years or end of the study (EOS) in case of early treatment discontinuation/completion. Key MRI endpoints included the annualised rate of formation of new/newly enlarging T2 lesions, gadolinium-enhancing (Gd+) T1 lesions, new T1 hypointense lesions and combined unique active (CUA) lesions (6 months onward), changes in T2 and Gd+ T1 lesion volumes and annualised rate of brain atrophy (ARBA).
RESULTS
Of the randomised patients, 107 each were treated with fingolimod and IFN β-1a for up to 2 years. Fingolimod reduced the annualised rate of formation of new/newly enlarging T2 lesions (52.6%, p<0.001), number of Gd+ T1 lesions per scan (66.0%, p<0.001), annualised rate of new T1 hypointense lesions (62.8%, p<0.001) and CUA lesions per scan (60.7%, p<0.001) versus IFN β-1a at EOS. The percent increases from baseline in T2 (18.4% vs 32.4%, p<0.001) and Gd+ T1 (-72.3% vs 4.9%, p=0.001) lesion volumes and ARBA (-0.48% vs -0.80%, p=0.014) were lower with fingolimod versus IFN β-1a, the latter partially due to accelerated atrophy in the IFN β-1a group.
CONCLUSION
Fingolimod significantly reduced MRI activity and ARBA for up to 2 years versus IFN β-1a in PoMS.",2020,Fingolimod significantly reduced MRI activity and ARBA for up to 2 years versus IFN β-1a in PoMS.,"['patients with paediatric-onset multiple sclerosis', 'paediatric-onset multiple sclerosis (PoMS', 'Patients with multiple sclerosis (MS) (aged 10-<18 years']","['fingolimod', 'fingolimod versus interferon β-1a (IFN β-1a', 'oral fingolimod (n=107) or once-weekly intramuscular IFN β-1a']","['number of Gd+ T1 lesions per scan', 'MRI activity and ARBA', 'MRI outcomes', 'annualised rate of formation of new/newly enlarging T2 lesions, gadolinium-enhancing (Gd+) T1 lesions, new T1 hypointense lesions and combined unique active (CUA) lesions (6 months onward), changes in T2 and Gd+ T1 lesion volumes and annualised rate of brain atrophy (ARBA', 'annualised rate of formation of new/newly enlarging T2 lesions', 'lesion volumes and ARBA', 'annualised rate of new T1 hypointense lesions', 'Gd+ T1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0441633'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0442800', 'cui_str': 'Enlarged (qualifier value)'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}]",,0.057622,Fingolimod significantly reduced MRI activity and ARBA for up to 2 years versus IFN β-1a in PoMS.,"[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'Montreal Neurological Institute, McGill University, Montreal, Quebec, Canada douglas.arnold@mcgill.ca.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Banwell', 'Affiliation': ""The Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bar-Or', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadephia, Pennsylvania, USA, Montreal, Quebec, Canada.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Ghezzi', 'Affiliation': 'Centro Studi Sclerosi Multipla, Ospedale di Gallarate, Gallarate, Italy.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Greenberg', 'Affiliation': 'Department of Neurology and Neurotherapeutics, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Waubant', 'Affiliation': 'Department of Neurology, University of California, San Francisco, California, USA.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University, London, UK.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'McGovern Medical School, Department of Neurology, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA, Houston, Texas, USA.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Gärtner', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, German Centre for Multiple Sclerosis in Childhood and Adolescence, University Medical Centre, Göttingen, Germany.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Rostásy', 'Affiliation': ""Division of Paediatric Neurology, Children's Hospital Datteln, University Witten/Herdecke, Datteln, Germany.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Krupp', 'Affiliation': 'Department of Neurology; Pediatric MS Center, NYU Langone Health, New York, NY USA, USA, New York, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Tardieu', 'Affiliation': 'Hôpitaux universitaires Paris Sud, Paediatric Neurology Department, Assistance Publique-Hôpitaux de Paris, Paris France, Paris, France.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Brück', 'Affiliation': 'Department of Neuropathology, University Medical Centre, Göttingen, Germany.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Stites', 'Affiliation': 'Neuroscience TA, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Pearce', 'Affiliation': 'GCE Solutions, Bloomington, Illinois, USA.'}, {'ForeName': 'Dieter A', 'Initials': 'DA', 'LastName': 'Häring', 'Affiliation': 'Neuroscience TA, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Merschhemke', 'Affiliation': 'Neuroscience TA, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Tanuja', 'Initials': 'T', 'LastName': 'Chitnis', 'Affiliation': 'Partners Pediatric Multiple Sclerosis Center, Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2019-322138']
231,32301645,Real Scarless Transoral Robotic Thyroidectomy Using Three Ports Without Axillary Incision.,"Introduction: Conventional transoral robotic thyroidectomy (TORT) requires an axillary incision and additional flap dissection. This study aimed to outline the first ever experiences with TORT using three ports without axillary incision and compare the results between three-port and four-port TORT. Materials and Methods: A total of 100 consecutive patients were enrolled. The study sample comprised 47 patients who underwent four-port TORT from November 2016 to June 2017, and 53 patients who underwent three-port TORT from September 2018 to June 2019. The indication of the three-port TORT was the anterior/posterior length of the thyroid <1.8 cm and mass size <1.5 cm. Results: Operative time (minutes) was shorter in the three-port group (166.3 ± 35.4 versus 138.5 ± 34.4, P = .005). Hospital stay (days) was also shorter in the three-port group (3.8 ± 0.4 versus 2.4 ± 0.6, P = .003). TORT using three ports yielded a higher cosmetic satisfaction (3.68 ± 0.52 versus 3.89 ± 0.30, P = .002). Postoperative complications, level of calcium, parathyroid hormone, and pain were not significantly different between the groups. Conclusions: Our study showed that three-port TORT was associated with a shorter operative time, hospital stay, and excellent cosmesis than the conventional four-port option. In conclusion, TORT using three ports is a comparable and an effective operation method as a real scarless operation.",2020,"Our study showed that three-port TORT was associated with a shorter operative time, hospital stay, and excellent cosmesis than the conventional four-port option.","['100 consecutive patients were enrolled', '47 patients who underwent four-port TORT from November 2016 to June 2017, and 53 patients who underwent three-port TORT from September 2018 to June 2019']","['Conventional transoral robotic thyroidectomy (TORT', 'Real Scarless Transoral Robotic Thyroidectomy Using Three Ports Without Axillary Incision', 'TORT']","['shorter operative time, hospital stay, and excellent cosmesis', 'cosmetic satisfaction', 'Postoperative complications, level of calcium, parathyroid hormone, and pain', 'Operative time (minutes', 'Hospital stay (days']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0040487', 'cui_str': 'Torts'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0040487', 'cui_str': 'Torts'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0191709', 'cui_str': 'Incision of axilla'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",100.0,0.030073,"Our study showed that three-port TORT was associated with a shorter operative time, hospital stay, and excellent cosmesis than the conventional four-port option.","[{'ForeName': 'Wan Wook', 'Initials': 'WW', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Kyungpook National University, School of Medicine, Daegu, Korea.'}, {'ForeName': 'Chan Sub', 'Initials': 'CS', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Kyungpook National University, School of Medicine, Daegu, Korea.'}, {'ForeName': 'Jeeyeon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Kyungpook National University, School of Medicine, Daegu, Korea.'}, {'ForeName': 'Jin Hyang', 'Initials': 'JH', 'LastName': 'Jung', 'Affiliation': 'Department of Surgery, Kyungpook National University, School of Medicine, Daegu, Korea.'}, {'ForeName': 'Ho Yong', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Kyungpook National University, School of Medicine, Daegu, Korea.'}, {'ForeName': 'Ralph P', 'Initials': 'RP', 'LastName': 'Tufano', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2020.0102']
232,31594431,Change in Cardiometabolic Risk Factors Associated With Magnitude of Weight Regain 3 Years After a 1-Year Intensive Lifestyle Intervention in Type 2 Diabetes Mellitus: The Look AHEAD Trial.,"Background Weight regain after weight loss is common. The impact on cardiometabolic risk factors is not well established. Methods and Results Publicly available data were analyzed from participants of the Look AHEAD (Action for Health in Diabetes) trial with ≥3% initial weight loss (n=1561) during a 1-year intensive lifestyle intervention and with year 4 follow-up data. Participants who regained (regainers) or maintained (maintainers) weight loss were defined with 5 dichotomized cut points (0%, 25%, 50%, 75%, and 100%) of percentage weight loss regained (weight change from years 1-4 as percentage of first year weight loss). Change in cardiometabolic risk factors after initial weight loss was compared in maintainers and regainers, after controlling for demographics, medications, and baseline and year 1 change in body mass index. The effect was assessed separately in participants with <10% and ≥10% initial weight loss, and women and men. Maintainers exhibited significant improvements to the cardiometabolic risk factors assessed compared with regainers. No weight regain cut point maximized risk difference between maintainers and regainers across risk factors or sex/initial weight loss subgroups. For many risk factors, allowing more regain as part of maintenance (increasing cut point) diminished the cardiometabolic benefit among maintainers. Conclusions Maintaining weight loss was better than regain for all risk factors. No single cut point maximized the risk difference between maintainers and regainers. Maintainers who kept off ≥75% of weight lost had the greatest benefit. These findings emphasize the importance of intervention programs focusing not only on weight loss but weight loss maintenance, given the adverse consequences of the latter. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00017953.",2019,Maintainers exhibited significant improvements to the cardiometabolic risk factors assessed compared with regainers.,"['Participants who regained (regainers) or maintained (maintainers', 'participants with <10% and ≥10% initial weight loss, and women and men', 'Type 2 Diabetes Mellitus']",['Intensive Lifestyle Intervention'],"['cardiometabolic risk factors', 'percentage weight loss regained (weight change', 'weight loss', 'Cardiometabolic Risk Factors']","[{'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0424661', 'cui_str': 'Percentage weight loss (observable entity)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0498345,Maintainers exhibited significant improvements to the cardiometabolic risk factors assessed compared with regainers.,"[{'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'Berger', 'Affiliation': 'Friedman School of Nutrition Science and Policy Tufts University Boston MA.'}, {'ForeName': 'Gordon S', 'Initials': 'GS', 'LastName': 'Huggins', 'Affiliation': 'Molecular Cardiology Research Institute Center for Translational Genomics Tufts Medical Center and Tufts University Boston MA.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'McCaffery', 'Affiliation': 'Department of Allied Health Sciences University of Connecticut Storrs CT.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Jacques', 'Affiliation': 'Friedman School of Nutrition Science and Policy Tufts University Boston MA.'}, {'ForeName': 'Alice H', 'Initials': 'AH', 'LastName': 'Lichtenstein', 'Affiliation': 'Friedman School of Nutrition Science and Policy Tufts University Boston MA.'}]",Journal of the American Heart Association,['10.1161/JAHA.118.010951']
233,31597504,Short-Term Changes in Cardiorespiratory Fitness in Response to Exercise Training and the Association with Long-Term Cardiorespiratory Fitness Decline: The STRRIDE Reunion Study.,"Background Substantial heterogeneity exists in the cardiorespiratory fitness (CRF) change in response to exercise training, and its long-term prognostic implication is not well understood. We evaluated the association between the short-term supervised training-related changes in CRF and CRF levels 10 years later. Methods and Results STRRIDE (Studies of a Targeted Risk Reduction Intervention Through Defined Exercise) trial participants who were originally randomized to exercise training for 8 months and participated in the 10-year follow-up visit were included. CRF levels were measured at baseline, after training (8 months), and at 10-year follow-up as peak oxygen uptake (vo 2 , mL/kg per min) using the maximal treadmill test. Participants were stratified into low, moderate, and high CRF response groups according to the training regimen-specific tertiles of CRF change. The study included 80 participants (age: 52 years; 35% female). At 10-year follow-up, the high-response CRF group had the least decline in CRF compared with the moderate- and low-response CRF groups (-0.35 versus -2.20 and -4.25 mL/kg per minute, respectively; P =0.02). This result was largely related to the differential age-related changes in peak oxygen pulse across the 3 groups (0.58, -0.23, and -0.86 mL/beat, respectively; P =0.03) with no difference in the peak heart rate change. In adjusted linear regression analysis, high response was significantly associated with greater CRF at follow-up independent of other baseline characteristics (high versus low [reference] CRF response: standard β=0.25; P =0.004). Conclusions Greater CRF improvement in response to short-term training is associated with higher CRF levels 10 years later. Lack of CRF improvements in response to short-term training may identify individuals at risk for exaggerated CRF decline with aging.",2019,Lack of CRF improvements in response to short-term training may identify individuals at risk for exaggerated CRF decline with aging.,"['for 8\xa0months and participated in the 10-year follow-up visit were included', '80 participants (age: 52\xa0years; 35% female']","['Exercise Training', 'exercise training']","['CRF levels', 'peak oxygen pulse', 'peak heart rate change', 'peak oxygen uptake', 'CRF']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}]",80.0,0.0179624,Lack of CRF improvements in response to short-term training may identify individuals at risk for exaggerated CRF decline with aging.,"[{'ForeName': 'Ambarish', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'Division of Cardiology Department of Internal Medicine UT Southwestern Medical Center Dallas TX.'}, {'ForeName': 'Johanna L', 'Initials': 'JL', 'LastName': 'Johnson', 'Affiliation': 'Duke Molecular Physiology Institute Duke University School of Medicine Durham NC.'}, {'ForeName': 'Cris A', 'Initials': 'CA', 'LastName': 'Slentz', 'Affiliation': 'Duke Molecular Physiology Institute Duke University School of Medicine Durham NC.'}, {'ForeName': 'Leanna M', 'Initials': 'LM', 'LastName': 'Ross', 'Affiliation': 'Duke Molecular Physiology Institute Duke University School of Medicine Durham NC.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Agusala', 'Affiliation': 'Division of Cardiology Department of Internal Medicine UT Southwestern Medical Center Dallas TX.'}, {'ForeName': 'Jarett D', 'Initials': 'JD', 'LastName': 'Berry', 'Affiliation': 'Division of Cardiology Department of Internal Medicine UT Southwestern Medical Center Dallas TX.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Duke Molecular Physiology Institute Duke University School of Medicine Durham NC.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.012876']
234,32272888,People living in nursing care facilities who are ambulant and fracture their hips: description of usual care and an alternative rehabilitation pathway.,"BACKGROUND
Little is known about treatment provided to people living in nursing care facilities (NCFs) after hospital admission for hip fracture. In addition, there are no clinical guidelines for rehabilitation and recovery following hip fracture for nursing home residents.
METHODS
As part of a randomised trial (SACRED trial), which investigated the efficacy of a four week in-reach rehabilitation program, data were collected which described routine care for 240 people living in 76 nursing care facilities in South Australia who fractured their hips. The in-reach rehabilitation provided to 119 intervention participants is described, including intensity, type and methods used to encourage participation in rehabilitation. Adverse events that occurred, in particular falls, are also reported.
RESULTS
NCF records indicated that, over the four weeks following discharge from hospital after hip fracture, 76% of patients receiving usual care had a consultation with their general practitioner. Physiotherapy was provided to 79% of patients in usual care (median of 1.96 h over the 4 weeks, which is less than 30 min each week of physiotherapy). In-reach rehabilitation was provided by the hospital team for 13 h over the 4 weeks with almost full attendance at physiotherapy sessions (median of 1 missed session, range 0-7 with a median of 14 physiotherapy sessions attended by participants, range 1-18). Experienced therapists provided a flexible approach to the rehabilitation to account for patients' dementia and associated neuropsychiatric symptoms while providing dietetic support, mobility training and education to nursing home staff. The number of falls experienced by those in the intervention group was higher compared to those in usual care (Relative Risk 1.38 (95%CI 1.04-1.84, p = 0.03).
CONCLUSIONS
Rehabilitation can be provided to people living in NCFs following hip fracture, even when they have moderate to severe dementia but the model needs to be flexible. Provision of rehabilitation may increase the rate of falls in this population. Further studies are required to establish the feasibility of the intervention in other long term care settings. (327 words).
TRIAL REGISTRATION
ACTRN12612000112864 registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR).",2020,"The number of falls experienced by those in the intervention group was higher compared to those in usual care (Relative Risk 1.38 (95%CI 1.04-1.84, p = 0.03).
","['People living in nursing care facilities who are ambulant and fracture their hips', 'people living in nursing care facilities (NCFs) after hospital admission for hip fracture', '240 people living in 76 nursing care facilities in South Australia who fractured their hips']",[],"['Adverse events', 'number of falls experienced', 'rate of falls']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}]",[],"[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",,0.0753096,"The number of falls experienced by those in the intervention group was higher compared to those in usual care (Relative Risk 1.38 (95%CI 1.04-1.84, p = 0.03).
","[{'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Killington', 'Affiliation': 'Flinders University, South Australia, Australia. Maggie.Killington@flinders.edu.au.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Davies', 'Affiliation': 'Flinders University, South Australia, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'Flinders University, South Australia, Australia.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Crane', 'Affiliation': 'Southern Adelaide Local Health Network, South Australia, Australia.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Pratt', 'Affiliation': 'Southern Adelaide Local Health Network, South Australia, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'Southern Adelaide Local Health Network, South Australia, Australia.'}, {'ForeName': 'Arabella', 'Initials': 'A', 'LastName': 'McInnes', 'Affiliation': 'Southern Adelaide Local Health Network, South Australia, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kurrle', 'Affiliation': 'Cognitive Decline Partnership Centre, University of Sydney, Hornsby Ku-ring-gai Hospital, Hornsby, New South Wales, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Cameron', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Kolling Institute, Faculty of Medicine and Health, University of Sydney, Camperdown, Australia.'}]",BMC geriatrics,['10.1186/s12877-019-1321-x']
235,32246765,Therapeutic role of granulocyte macrophage colony-stimulating factor (GM-CSF) in patients with persistent thin endometrium: A prospective and randomized study.,"OBJECTIVE
To assess the effect of granulocyte macrophage colony-stimulating factor (GM-CSF) on unresponsive thin (<7 mm) endometrium in women undergoing frozen-thawed embryo transfer.
METHODS
A single-center, randomized, prospective study enrolled 304 women with thin unresponsive endometrium from Shanghai Ninth People's Hospital between March 2017 and May 2018. Of them, 161 patients received an intrauterine infusion of GM-CSF and 143 patients served as controls. After hysteroscopy, a gel with or without GM-CSF was administered to fill the uterine cavity completely or up to 5 mL only. The primary outcome was confirmed pregnancy and secondary outcomes included endometrial thickness and implantation rate.
RESULTS
Patients who were administered GM-CSF had a significantly higher chemical pregnancy rate (35.3% vs 20.0%; P=0.009) and clinical pregnancy rate (28.6% vs 13.3%; P=0.005) compared with patients in the control group. Patients treated with GM-CSF had significantly higher endometrial thickness compared with controls (7.83 ± 1.45 mm vs 7.37 ± 0.70 mm, P=0.003).
CONCLUSION
GM-CSF therapy can effectively increase endometrial thickness and improve the clinical pregnancy rate in patients with persistent thin endometrium. The therapeutic role of GM-CSF for infertile women under in vitro fertilization and embryo transfer (IVF-ET) treatment can be further explored.
CHINESE CLINICAL TRIAL REGISTER
ChiCTR-IPR-17011242.",2020,"Patients treated with GM-CSF had significantly higher endometrial thickness compared with controls (7.83±1.45 mm vs 7.37±0.70 mm, P=0.003).
","['patients with persistent thin endometrium', '161 patients received an', 'infertile women under in vitro fertilization and embryo transfer (IVF-ET', 'women undergoing frozen-thawed embryo transfer', ""304 women with thin unresponsive endometrium from Shanghai Ninth People's Hospital between March 2017 and May 2018""]","['intrauterine infusion of GM-CSF', 'GM-CSF', 'gel-with or without GM-CSF', 'GM-CSF therapy', 'granulocyte macrophage colony-stimulating factor (GM-CSF']","['endometrial thickness and implantation rate', 'clinical pregnancy rate', 'chemical pregnancy rate', 'endometrial thickness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205443', 'cui_str': 'Ninth'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0860381', 'cui_str': 'GM-CSF therapy'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C2919902', 'cui_str': 'Chemical pregnancy'}]",304.0,0.0945502,"Patients treated with GM-CSF had significantly higher endometrial thickness compared with controls (7.83±1.45 mm vs 7.37±0.70 mm, P=0.003).
","[{'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Mao', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Renfei', 'Initials': 'R', 'LastName': 'Cai', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Hongyuan', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Kuang', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shaozhen', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13152']
236,31699720,MEchanical DIlatation of the Cervix-- in a Scarred uterus (MEDICS): the study protocol of a randomised controlled trial comparing a single cervical catheter balloon and prostaglandin PGE2 for cervical ripening and labour induction following caesarean delivery.,"INTRODUCTION
Labour induction in women with a previous caesarean delivery currently uses vaginal prostaglandin E2 (PGE2), which carries the risks of uterine hyperstimulation and scar rupture. We aim to compare the efficacy of mechanical labour induction using a transcervically applied Foley catheter balloon (FCB) with PGE2 in affected women attempting trial of labour after caesarean (TOLAC).
METHODS AND ANALYSIS
This single-centre non-inferiority prospective, randomised, open, blinded-endpoint study conducted at an academic maternity unit in Singapore will recruit a total of 100 women with one previous uncomplicated caesarean section and no contraindications to vaginal delivery. Eligible consented participants with term singleton pregnancies and unfavourable cervical scores (≤5) requiring labour induction undergo stratified randomisation based on parity and are assigned either FCB (n=50) or PGE2 (n=50). Treatments are applied for up to 12 hours with serial monitoring of the mother and the fetus and serial assessment for improved cervical scores. If the cervix is still unfavourable, participants are allowed a further 12 hours' observation for cervical ripening. Active labour is initiated by amniotomy at cervical scores of ≥6. The primary outcome is the rate of change in the cervical score, and secondary outcomes include active labour within 24 hours of induction, vaginal delivery, time-to-delivery interval and uterine hyperstimulation. All analyses will be intention-to-treat. The data generated in this trial may guide a change in practice towards mechanical labour induction if this proves efficient and safer for women attempting TOLAC compared with PGE2, to improve labour management in this high-risk population.
ETHICS AND DISSEMINATION
Ethical approval is granted by the Domain Specific Review Board (Domain D) of the National Healthcare Group, Singapore. All adverse events will be reported within 24 hours of notification for assessment of causality. Data will be published and will be available for future meta-analyses.
TRIAL REGISTRATION NUMBER
NCT03471858; Pre-results.",2019,"We aim to compare the efficacy of mechanical labour induction using a transcervically applied Foley catheter balloon (FCB) with PGE2 in affected women attempting trial of labour after caesarean (TOLAC).
","['women with a previous caesarean delivery currently uses', 'academic maternity unit in Singapore will recruit a total of 100 women with one previous uncomplicated caesarean section and no contraindications to vaginal delivery', 'affected women attempting trial of labour after caesarean (TOLAC', 'cervical ripening and labour induction following caesarean delivery', 'Eligible consented participants with term singleton pregnancies and unfavourable cervical scores (≤5) requiring labour induction undergo stratified randomisation based on parity and are assigned either FCB (n=50) or PGE2 (n=50']","['vaginal prostaglandin E2 (PGE2', 'cervical catheter balloon and prostaglandin PGE2', 'mechanical labour induction using a transcervically applied Foley catheter balloon (FCB) with PGE2']","['rate of change in the cervical score, and secondary outcomes include active labour within 24\u2009hours of induction, vaginal delivery, time-to-delivery interval and uterine hyperstimulation', 'cervical scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0600454', 'cui_str': 'Ripenings, Cervical'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0179804'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0233081', 'cui_str': 'Normal labor (finding)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0269842', 'cui_str': 'Hypertonic uterine dysfunction (disorder)'}]",100.0,0.199292,"We aim to compare the efficacy of mechanical labour induction using a transcervically applied Foley catheter balloon (FCB) with PGE2 in affected women attempting trial of labour after caesarean (TOLAC).
","[{'ForeName': 'Soe-Na', 'Initials': 'SN', 'LastName': 'Choo', 'Affiliation': 'Obstetrics and Gynaecology, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Abhiram', 'Initials': 'A', 'LastName': 'Kanneganti', 'Affiliation': 'Obstetrics and Gynaecology, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Muhammad Nur Dinie Bin', 'Initials': 'MNDB', 'LastName': 'Abdul Aziz', 'Affiliation': 'Obstetrics and Gynaecology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Leta', 'Initials': 'L', 'LastName': 'Loh', 'Affiliation': 'Obstetrics and Gynaecology, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Hargreaves', 'Affiliation': 'Data Analytics Consulting Centre, Faculty of Science, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Vikneswaran', 'Initials': 'V', 'LastName': 'Gopal', 'Affiliation': 'Data Analytics Consulting Centre, Faculty of Science, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Biswas', 'Affiliation': 'Obstetrics and Gynaecology, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Yiong Huak', 'Initials': 'YH', 'LastName': 'Chan', 'Affiliation': 'Biostatistics Unit, Yong Loo Lin School of Medicine, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Ida Suzani', 'Initials': 'IS', 'LastName': 'Ismail', 'Affiliation': 'Obstetrics and Gynaecology, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Chi', 'Affiliation': 'Obstetrics and Gynaecology, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Citra', 'Initials': 'C', 'LastName': 'Mattar', 'Affiliation': 'Obstetrics and Gynaecology, National University Hospital, Singapore, Singapore citramattar@nus.edu.sg.'}]",BMJ open,['10.1136/bmjopen-2019-028896']
237,32286232,Impact of a Web-Based Exercise and Nutritional Education Intervention in Patients Who Are Obese With Hypertension: Randomized Wait-List Controlled Trial.,"BACKGROUND
Internet-based interventions are a promising strategy for promoting healthy lifestyle behaviors. These have a tremendous potential for delivering electronic health interventions in scalable and cost-effective ways. There is strong evidence that the use of these programs can lead to weight loss and can lower patients' average blood pressure (BP) levels. So far, few studies have investigated the effects of internet-based programs on patients who are obese with hypertension (HTN).
OBJECTIVE
The aim of this study is to investigate the short- and long-term efficacy, in terms of body composition and BP parameters, of a self-administered internet-based intervention involving different modules and learning techniques aimed at promoting lifestyle changes (both physical activity and healthy eating) in patients who are obese with HTN.
METHODS
A randomized wait-list controlled trial design was used. We recruited 105 adults with HTN who were overweight or obese and randomly assigned them to either a 3-month internet-based intervention group (n=55) or the wait-list control group (n=50). We assessed BMI (primary outcome), body fat mass (BFM), systolic (S)BP and diastolic (D)BP, blood glucose and insulin levels, physical activity levels, and functional capacity for aerobic exercise at Time 0 (preintervention) and Time 1 (postintervention). All the patients in the wait-list control group subsequently received the intervention, and a secondary within-group analysis, which also included these participants, was conducted at Time 2 (12-month follow-up).
RESULTS
A 2-way mixed analysis of covariance showed a significant decrease in BMI, BFM, and blood glucose at 3 months in the internet-based intervention group; the effect size for the BMI and BFM parameters was moderate to large, and there was also a borderline significant trend for DBP and insulin. These results were either maintained or improved upon at Time 2 and showed significant changes for BMI (mean difference -0.4, 95% CI -0.1 to -0.6; P=.005), BFM (mean difference -2.4, 95% CI -1.1 to -3.6; P<.001), DBP (mean difference -1.8, 95% CI -0.2 to -3.3; P=.03), and blood glucose (mean difference -2, 95% CI 0 to -4; P=.04).
CONCLUSIONS
Implementation of our self-administered internet-based intervention, which involved different learning techniques aimed to promote lifestyle changes, resulted in positive short- and long-term health benefits in patients who are obese with HTN.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03396302; https://clinicaltrials.gov/ct2/show/NCT03396302.",2020,There is strong evidence that the use of these programs can lead to weight loss and can lower patients' average blood pressure (BP) levels.,"['patients who are obese with hypertension (HTN', 'patients who are obese with HTN', 'Patients', 'Who Are Obese With Hypertension', '105 adults with HTN who were overweight or obese']","['3-month internet-based intervention group (n=55) or the wait-list control group', 'self-administered internet-based intervention involving different modules and learning techniques aimed at promoting lifestyle changes (both physical activity and healthy eating', 'Web-Based Exercise and Nutritional Education Intervention']","['DBP and insulin', 'blood pressure (BP) levels', 'BMI (primary outcome), body fat mass (BFM), systolic (S)BP and diastolic (D)BP, blood glucose and insulin levels, physical activity levels, and functional capacity for aerobic exercise at Time 0 (preintervention) and Time 1 (postintervention', 'BMI', 'blood glucose', 'DBP ', 'BFM', 'BMI and BFM parameters', 'BMI, BFM, and blood glucose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",105.0,0.163935,There is strong evidence that the use of these programs can lead to weight loss and can lower patients' average blood pressure (BP) levels.,"[{'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Lisón', 'Affiliation': 'Department of Medicine, Universidad Cardenal Herrera CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Palomar', 'Affiliation': 'Primary Care Health Center, Quartell, Spain.'}, {'ForeName': 'Marinna S', 'Initials': 'MS', 'LastName': 'Mensorio', 'Affiliation': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior Foundation, Brasilia, Brazil.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología Obesidad y Nutrición, Instituto Carlos III, Madrid, Spain.'}, {'ForeName': 'Ausiàs', 'Initials': 'A', 'LastName': 'Cebolla-Martí', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología Obesidad y Nutrición, Instituto Carlos III, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología Obesidad y Nutrición, Instituto Carlos III, Madrid, Spain.'}, {'ForeName': 'Vicent', 'Initials': 'V', 'LastName': 'Benavent-Caballer', 'Affiliation': 'Department of Physiotherapy, Universidad Cardenal Herrera CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Rodilla', 'Affiliation': 'Department of Medicine, Universidad Cardenal Herrera CEU, CEU Universities, Valencia, Spain.'}]",Journal of medical Internet research,['10.2196/14196']
238,32301579,Cognitive bias modification for threat interpretations: Impact on anxiety symptoms and stress reactivity.,"BACKGROUND
Cognitive bias modification for interpretations (CBM-I) is a computerized intervention that has received increasing attention in the last decade as a potential experimental intervention for anxiety. Initial CBM-I trials with clinical populations suggest the potential utility of this approach. However, most CBM-I experiments have been conducted with unaffected samples, few (one or two) training sessions, and have not examined transfer effects to anxiety-related constructs such as stress reactivity.
METHOD
This study compared a 12-session CBM-I intervention (n = 12) to an interpretation control condition (ICC; n = 12) in individuals (N = 24) with elevated trait anxiety on interpretation bias, anxiety symptom, and stress reactivity outcomes (electrodermal activity, heart rate, and respiratory sinus arrhythmia).
RESULTS
Compared to the ICC group, participants assigned to CBM-I experienced significantly greater improvements in interpretation bias and anxiety symptoms by post-intervention 4 weeks later, with impact on anxiety maintained at 1-month follow-up. While CBM-I and ICC groups did not differ in stress reactivity during an acute stressor at pre-intervention, the CBM-I group evidenced improved stress reactivity at post-intervention compared to ICC on two psychophysiological indices, electrodermal activity and heart rate.
CONCLUSIONS
The results of this pilot study suggest that CBM-I may hold promise for reducing anxiety symptoms, as well as impact psychophysiological arousal during an acute stressor.",2020,"Compared to the ICC group, participants assigned to CBM-I experienced significantly greater improvements in interpretation bias and anxiety symptoms by post-intervention 4 weeks later, with impact on anxiety maintained at 1-month follow-up.",[],"['12-session CBM-I intervention (n\u2009=\u200912) to an interpretation control condition (ICC', 'ICC']","['anxiety symptoms and stress reactivity', 'elevated trait anxiety on interpretation bias, anxiety symptom, and stress reactivity outcomes (electrodermal activity, heart rate, and respiratory sinus arrhythmia', 'stress reactivity', 'psychophysiological indices, electrodermal activity and heart rate', 'interpretation bias and anxiety symptoms', 'anxiety symptoms']",[],"[{'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",24.0,0.0301572,"Compared to the ICC group, participants assigned to CBM-I experienced significantly greater improvements in interpretation bias and anxiety symptoms by post-intervention 4 weeks later, with impact on anxiety maintained at 1-month follow-up.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Rozenman', 'Affiliation': 'Department of Psychology, University of Denver, Denver, Colorado.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Psychology, California State University, Long Beach, California.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Logan', 'Affiliation': 'Department of Psychology, California State University, Long Beach, California.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Goger', 'Affiliation': 'San Diego State University (SDSU)/University of California, San Diego (UCSD), Joint Doctoral Program in Clinical Psychology, San Diego, California.'}]",Depression and anxiety,['10.1002/da.23018']
239,32301591,Improvement of sexual functioning during treatment of MDD with adjunctive pimavanserin: A secondary analysis.,"BACKGROUND
Sexual dysfunction is common among patients with major depressive disorder (MDD). In the CLARITY study, the safety and efficacy of adjunctive pimavanserin, an inverse agonist at 5-HT 2A receptors, were demonstrated when added to existing treatment for MDD. This analysis provides a detailed assessment of the effects of pimavanserin on sexual function from the CLARITY study.
METHODS
Patients with a diagnosis of MDD in a depressive episode, inadequate response to ongoing antidepressant therapy, and a Montgomery-Åsberg Depression Rating Scale total score >20 were randomized to pimavanserin 34 mg/day or placebo added to ongoing treatment with an immediate revision of all selective serotonin or serotonin-norepinephrine for 5 weeks (Stage 1), and nonresponders (<50% improvement from baseline in Hamilton Depression Rating Scale [HAMD-17]) were re-randomized for an additional 5 week (Stage 2). Effects of pimavanserin on the Massachusetts General Hospital Sexual Functioning Index (MGH-SFI) and HAMD-17 Item 14 (sexual interest) were examined.
RESULTS
Among 203 patients (51 on pimavanserin; 152 on placebo), pimavanserin demonstrated significant improvement from baseline to Week 5 on the MGH-SFI (least square [LS]mean difference -0.634, 95% confidence interval [CI] [-0.964, -0.304]; p = .0002; effect size [ES], Cohen's d: .614). Across Stages 1 and 2, the weighted LSmean difference was -0.468 (95% CI [-0.720, -0.216]; p = .0003) for pimavanserin versus placebo. Mean changes from baseline to Week 5 for MGH-SFI Items 1, 2, 3, and 5 and HAMD Item 14 were significantly (p < .05) greater with pimavanserin versus placebo.
CONCLUSIONS
Adjunctive pimavanserin improved sexual function in patients with MDD. Adding pimavanserin to ongoing treatment for MDD may be especially useful for patients experiencing sexual dysfunction.",2020,"Effects of pimavanserin on the Massachusetts General Hospital Sexual Functioning Index (MGH-SFI) and HAMD-17 Item 14 (sexual interest) were examined.
","['patients experiencing sexual dysfunction', 'patients with MDD', 'Patients with a diagnosis of MDD in a depressive episode, inadequate response to ongoing antidepressant therapy, and a Montgomery-Åsberg Depression Rating Scale total score >20', '203 patients (51 on pimavanserin; 152 on', 'patients with major depressive disorder (MDD']","['adjunctive pimavanserin', 'pimavanserin 34\u2009mg/day or placebo added to ongoing treatment with an immediate revision of all selective serotonin or serotonin-norepinephrine', 'placebo', 'placebo), pimavanserin', 'pimavanserin']","['sexual functioning', 'MGH-SFI', 'Massachusetts General Hospital Sexual Functioning Index (MGH-SFI) and HAMD-17 Item 14 (sexual interest', 'sexual function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1096649', 'cui_str': 'Antidepressant therapy'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1722267', 'cui_str': 'pimavanserin'}]","[{'cui': 'C1722267', 'cui_str': 'pimavanserin'}, {'cui': 'C4704362', 'cui_str': 'pimavanserin 34 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424400', 'cui_str': 'Erotic interest'}]",203.0,0.0952581,"Effects of pimavanserin on the Massachusetts General Hospital Sexual Functioning Index (MGH-SFI) and HAMD-17 Item 14 (sexual interest) were examined.
","[{'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dirks', 'Affiliation': 'Medical Department, ACADIA Pharmaceuticals Inc., San Diego, California.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Medical Department, ACADIA Pharmaceuticals Inc., San Diego, California.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'Medical Department, ACADIA Pharmaceuticals Inc., San Diego, California.'}]",Depression and anxiety,['10.1002/da.23017']
240,32299679,"A multicenter, randomized, placebo-controlled, double-blind phase 3 trial with open-arm comparison indicates safety and efficacy of nephroprotective therapy with ramipril in children with Alport's syndrome.","Children with Alport syndrome develop renal failure early in life. Since the safety and efficacy of preemptive nephroprotective therapy are uncertain we conducted a randomized, placebo-controlled, double-blind trial in 14 German sites of pediatric patients with ramipril for three to six years plus six months follow-up to determine these parameters. Pretreated children and those whose parents refused randomization became an open-arm control, which were compared to prospective real-world data from untreated children. The co-primary endpoints were safety (adverse drug reactions) and efficacy (time to progression). Out of 66 oligosymptomatic children, 22 were randomized and 44 joined the open-arm comparison. Ramipril therapy showed no safety issues (total of 216.4 patient-years on ramipril; adverse event rate-ratio 1.00; 95% confidence interval 0.66-1.53). Although not significant, our results cautiously showed that ramipril therapy was effective: in the randomized arm, Ramipril decreased the risk of disease progression by almost half (hazard ratio 0.51 (0.12-2.20)), diminished the slope of albuminuria progression and the decline in glomerular filtration. In adjusted analysis, indications of efficacy were supported by prospective data from participants treated open label compared with untreated children, in whom ramipril again seemed to reduce progression by almost half (0.53 (0.22-1.29)). Incorporating these results into the randomized data by Bayesian evidence synthesis resulted in a more precise estimate of the hazard-ratio of 0.52 (0.19-1.39). Thus, our study shows the safety of early initiation of therapy and supports the hope to slow renal failure by many years, emphasizing the value of preemptive therapy. Hence, screening programs for glomerular hematuria in children and young adults could benefit from inclusion of genetic testing for Alport-related gene-variants.",2020,Ramipril therapy showed no safety issues (total of 216.4 patient-years on ramipril; adverse event rate-ratio 1.00; 95% confidence interval 0.66-1.53).,"['66 oligosymptomatic children', 'Children with Alport syndrome develop renal failure early in life', 'children and young adults', ""children with Alport's syndrome"", '14 German sites of pediatric patients with ramipril for three to six years plus six months']","['placebo', 'Ramipril', 'ramipril', 'nephroprotective therapy with ramipril', 'preemptive nephroprotective therapy']","['slope of albuminuria progression', 'safety and efficacy', 'safety (adverse drug reactions) and efficacy (time to progression', 'glomerular filtration', 'reduce progression', 'risk of disease progression']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1567741', 'cui_str': 'Alport syndrome'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C3267042', 'cui_str': 'Nephroprotective therapy'}]","[{'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",66.0,0.200707,Ramipril therapy showed no safety issues (total of 216.4 patient-years on ramipril; adverse event rate-ratio 1.00; 95% confidence interval 0.66-1.53).,"[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gross', 'Affiliation': 'Clinic for Nephrology and Rheumatology, University Medical Center Göttingen, Göttingen, Germany. Electronic address: gross.oliver@med.uni-goettingen.de.'}, {'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Tönshoff', 'Affiliation': ""Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.""}, {'ForeName': 'Lutz T', 'Initials': 'LT', 'LastName': 'Weber', 'Affiliation': 'Pediatric Nephrology, Children`s and Adolescents` Hospital, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Pape', 'Affiliation': 'Department of Pediatric Kidney, Liver and Metabolic Diseases, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Latta', 'Affiliation': 'Clementine Kinderhospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Fehrenbach', 'Affiliation': ""Pediatric Nephrology, Children's Hospital, Memmingen, Germany.""}, {'ForeName': 'Baerbel', 'Initials': 'B', 'LastName': 'Lange-Sperandio', 'Affiliation': ""Dr. v. Hauner Children's Hospital, Ludwig Maximilians University, Munich, Germany.""}, {'ForeName': 'Hildegard', 'Initials': 'H', 'LastName': 'Zappel', 'Affiliation': 'Clinic of Pediatrics and Adolescent Medicine, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hoyer', 'Affiliation': 'Pediatric Nephrology, Pediatrics II, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Hagen', 'Initials': 'H', 'LastName': 'Staude', 'Affiliation': ""Pediatric Nephrology, University Children's Hospital Rostock, Rostock, Germany.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'König', 'Affiliation': ""University Children's Hospital Münster, Münster, Germany.""}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'John', 'Affiliation': ""Division of Pediatric Nephrology, University Children's Hospital, Jena, Germany.""}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Gellermann', 'Affiliation': ""Pediatric Nephrology, Charité Children's Hospital, Berlin, Germany.""}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hoppe', 'Affiliation': 'Division of Pediatric Nephrology, Department of Pediatrics, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Galiano', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, University Hospital, Friedrich-Alexander-University Erlangen, Erlangen, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Hoecker', 'Affiliation': ""Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.""}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Ehren', 'Affiliation': 'Pediatric Nephrology, Children`s and Adolescents` Hospital, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lerch', 'Affiliation': 'Department of Pediatric Kidney, Liver and Metabolic Diseases, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Clifford E', 'Initials': 'CE', 'LastName': 'Kashtan', 'Affiliation': 'Department of Pediatrics, Division of Nephrology, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Harden', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Boeckhaus', 'Affiliation': 'Clinic for Nephrology and Rheumatology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international,['10.1016/j.kint.2019.12.015']
241,32302640,Randomized controlled trial comparing glass fiber posts and cast metal posts.,"OBJECTIVE
This study aimed to assess the survival and success of glass fiber posts compared to cast metal posts in teeth without ferrule.
MATERIAL AND METHODS
An equivalency, prospective, double-blind (patient and outcome evaluator) randomized controlled trial (RCT) with parallel groups was designed to compare the clinical performance of cast metal and glass fiber posts cemented in endodontically treated teeth without ferrule (NCT01461239). Teeth were randomly allocated to the glass fiber or cast-metal post groups. All teeth were restored with single metal-ceramic crowns. Kaplan-Meier analysis with the log-rank test was used to test the success and survival between glass fiber and cast metal posts considering a cut-off value of P = 0.05. The annual failure rates were calculated considering the survival data for all restorations and separated by type of post after five years.
RESULTS
A hundred and nineteen patients and 183 posts (72 cast metal posts and 111 glass fiber posts) were analyzed. The median follow-up was 62 months (IQR 37-81). The log-rank test for success (P = 0.26) and survival (P = 0.63) analyses did not present statistically significant differences. The AFR of both posts after 5 years was 1.5%. Considering the posts separately and after 5 years, cast metal posts presented AFR of 1.2% and glass fiber posts AFR of 1.7%. Most failures were in posterior teeth (16/23), 10 failures were classified as root fractures and 5 as post debonding. The follow-up rate was 95.3%.
CONCLUSIONS
Glass fiber and cast metal posts showed good and similar clinical performance.
CLINICAL SIGNIFICANCE
Results of this randomized controlled trial can help dentists to answer how the best technique to rehabilitate endodontically treated teeth with no remaining coronal wall.",2020,The log-rank test for success (P = 0.26) and survival (P = 0.63) analyses did not present statistically significant differences.,['A hundred and nineteen patients and 183 posts (72 cast metal posts and 111 glass fiber posts'],"['glass fiber or cast-metal post groups', 'glass fiber posts and cast metal posts', 'cast metal posts', 'glass fiber posts']","['survival and success', 'log-rank test for success', 'annual failure rates', 'survival']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439873', 'cui_str': 'Cast metal'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0060317', 'cui_str': 'Fiberglass'}]","[{'cui': 'C0060317', 'cui_str': 'Fiberglass'}, {'cui': 'C0439873', 'cui_str': 'Cast metal'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",,0.152641,The log-rank test for success (P = 0.26) and survival (P = 0.63) analyses did not present statistically significant differences.,"[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Sarkis-Onofre', 'Affiliation': 'Graduate Program in Dentistry, Meridional Faculty (IMED), 304 Senador Pinheiro Machado Street, 99070-220, Passo Fundo, Brazil; Graduate Program in Dentistry, Federal University of Pelotas, 457 Gonçalves Chaves Street, Pelotas, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Amaral Pinheiro', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, 457 Gonçalves Chaves Street, Pelotas, Brazil.'}, {'ForeName': 'Victório', 'Initials': 'V', 'LastName': 'Poletto-Neto', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, 457 Gonçalves Chaves Street, Pelotas, Brazil.'}, {'ForeName': 'César Dalmolin', 'Initials': 'CD', 'LastName': 'Bergoli', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, 457 Gonçalves Chaves Street, Pelotas, Brazil.'}, {'ForeName': 'Maximiliano Sérgio', 'Initials': 'MS', 'LastName': 'Cenci', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, 457 Gonçalves Chaves Street, Pelotas, Brazil.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Pereira-Cenci', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, 457 Gonçalves Chaves Street, Pelotas, Brazil. Electronic address: Tatiana.cenci@ufpel.tche.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103334']
242,32166877,Effect of adding azithromycin to the antimalarials used for seasonal malaria chemoprevention on the nutritional status of African children.,"OBJECTIVES
Mass administration of azithromycin has reduced mortality in children in sub-Saharan Africa but its mode of action is not well characterised. A recent trial found that azithromycin given alongside seasonal malaria chemoprevention was not associated with a reduction in mortality or hospital admissions in young children. We investigated the effect of azithromycin on the nutritional status of children enrolled in this study.
METHODS
A total of 19 578 children in Burkina Faso and Mali were randomised to receive either azithromycin or placebo alongside seasonal malaria chemoprevention with sulfadoxine-pyrimethamine plus amodiaquine monthly for three malaria transmission seasons (2014-2016). After each transmission season, anthropometric measurements were collected from approximately 4000 randomly selected children (2000 per country) at a cross-sectional survey and used to derive nutritional status indicators. Binary and continuous outcomes between treatment arms were compared by Poisson and linear regression.
RESULTS
Nutritional status among children was poor in both countries with evidence of acute and chronic malnutrition (24.9-33.3% stunted, 15.8-32.0% underweight, 7.2-26.4% wasted). There was a suggestion of improvement in nutritional status in Burkina Faso and deterioration in Mali over the study period. At the end of each malaria transmission season, nutritional status of children did not differ between treatment arms (seasonal malaria chemoprevention plus azithromycin or placebo) in either the intention-to-treat or per-protocol analyses (only children with at least three cycles of SMC in the current intervention year).
CONCLUSIONS
The addition of azithromycin to seasonal malaria chemoprevention did not result in an improvement of nutritional outcomes in children in Burkina Faso and Mali.",2020,The addition of azithromycin to seasonal malaria chemoprevention did not result in an improvement of nutritional outcomes in children in Burkina Faso and Mali.,"['African Children', '19,578 children in Burkina Faso and Mali', 'children in Burkina Faso and Mali', 'young children', 'children enrolled in this study']","['azithromycin', 'Azithromycin', 'azithromycin or placebo', 'sulfadoxine-pyrimethamine plus amodiaquine']","['nutritional outcomes', 'acute and chronic malnutrition', 'mortality or hospital admissions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0024581', 'cui_str': 'Republic of Mali'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0700599', 'cui_str': 'Pyrimethamine / Sulfadoxine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",19578.0,0.0562404,The addition of azithromycin to seasonal malaria chemoprevention did not result in an improvement of nutritional outcomes in children in Burkina Faso and Mali.,"[{'ForeName': 'Georgia R', 'Initials': 'GR', 'LastName': 'Gore-Langton', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cairns', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Yves Daniel', 'Initials': 'YD', 'LastName': 'Compaoré', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kuepfer', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Zongo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Mariken M', 'Initials': 'MM', 'LastName': 'de Wit', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Barry', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Modibo', 'Initials': 'M', 'LastName': 'Diarra', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Tapily', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Samba', 'Initials': 'S', 'LastName': 'Coumare', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Thera', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Nikiema', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'R Serge', 'Initials': 'RS', 'LastName': 'Yerbanga', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Rosemonde M', 'Initials': 'RM', 'LastName': 'Guissou', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'Malaria Research and Training Center, University of Science, Techniques, and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chandramohan', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Greenwood', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Jean Bosco', 'Initials': 'JB', 'LastName': 'Ouedraogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13390']
243,32290148,"Effects of Aerobic-, Anaerobic- and Combined-Based Exercises on Plasma Oxidative Stress Biomarkers in Healthy Untrained Young Adults.","Currently, it is well accepted that physical exercise-induced oxidative stress may damage biological structures and impair cellular functions. However, it is still unclear which type of exercise results in the greatest oxidative stress responses among a healthy untrained population. The aim of the present study was to compare the acute oxidative stress response (i.e., 0 to 20 min) following different types of exercise (anaerobic, aerobic, and combined). Ten healthy, untrained males (19.5 ± 1.7 years) performed three randomized exercise bouts: anaerobic (30 s Wingate test), aerobic (30 min at 60% maximal aerobic power (MAP)) or combined (anaerobic and aerobic). Venous blood samples were collected before, as well as at 0 (P0), 5 (P5), 10 (P10), and 20 (P20) min after each session. Rates of malondialdehyde (MDA) and antioxidant activities (i.e., glutathione peroxidase (GPX), superoxide dismutase (SOD), glutathione reductase (GR), α-tocopherol, and total antioxidant status (TAS)) were assessed. Independent of exercise type, plasma MDA, GPX, SOD, and GR contents increased above baseline, whereas plasma α-tocopherol decreased under baseline after the test sessions ( p < 0.05). Aerobic and anaerobic exercises generated faster responses (at P0) when compared to the combined exercise (P5 to P10) for the majority of the tested parameters. Plasma TAS content only increased following the aerobic exercise at P10 ( p = 0.03). Five to twenty-minutes post exercise, the highest MDA response was registered in the aerobic condition, and the highest GPX and SOD responses were recorded in the anaerobic (at P5) and aerobic (at P20) conditions ( p < 0.05). In conclusion, aerobic, anaerobic, or combined exercises have the potential to acutely increase oxidative stress and antioxidant activities, but with different responses magnitude. These findings confirm that oxidative stress response seems to be dependent on the intensity and the duration of the physical exercise and may help in understanding how varying exercise bouts influence the degree of oxidative stress among healthy untrained young adults.",2020,"Rates of malondialdehyde (MDA) and antioxidant activities (i.e., glutathione peroxidase (GPX), superoxide dismutase (SOD), glutathione reductase (GR), α-tocopherol, and total antioxidant status (TAS)) were assessed.","['healthy untrained young adults', 'healthy untrained population', 'Healthy Untrained Young Adults', 'Ten healthy, untrained males (19.5 ± 1.7 years) performed three']","['Aerobic-, Anaerobic- and Combined-Based Exercises', 'exercise (anaerobic, aerobic, and combined', 'Aerobic and anaerobic exercises', 'randomized exercise bouts: anaerobic (30 s Wingate test), aerobic (30 min at 60% maximal aerobic power (MAP)) or combined (anaerobic and aerobic']","['Plasma Oxidative Stress Biomarkers', 'Venous blood samples', 'highest MDA response', 'oxidative stress and antioxidant activities', 'plasma MDA, GPX, SOD, and GR contents', 'Rates of malondialdehyde (MDA) and antioxidant activities (i.e., glutathione peroxidase (GPX), superoxide dismutase (SOD), glutathione reductase (GR), α-tocopherol, and total antioxidant status (TAS', 'Plasma TAS content', 'highest GPX and SOD responses', 'acute oxidative stress response', 'plasma α-tocopherol']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0017824', 'cui_str': 'Glutathione reductase (NAD(P)H)'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.0476807,"Rates of malondialdehyde (MDA) and antioxidant activities (i.e., glutathione peroxidase (GPX), superoxide dismutase (SOD), glutathione reductase (GR), α-tocopherol, and total antioxidant status (TAS)) were assessed.","[{'ForeName': 'Achraf', 'Initials': 'A', 'LastName': 'Ammar', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke-University Magdeburg, 39106 Magdeburg, Germany.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Trabelsi', 'Affiliation': ""Institut Supérieur du Sport et de l'Education Physique de Sfax, Université de Sfax, Sfax 3000, Tunisia.""}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Boukhris', 'Affiliation': ""Institut Supérieur du Sport et de l'Education Physique de Sfax, Université de Sfax, Sfax 3000, Tunisia.""}, {'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Glenn', 'Affiliation': 'Neurotrack Technologies, Redwood City, CA 94063, USA.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bott', 'Affiliation': 'Neurotrack Technologies, Redwood City, CA 94063, USA.'}, {'ForeName': 'Liwa', 'Initials': 'L', 'LastName': 'Masmoudi', 'Affiliation': ""Institut Supérieur du Sport et de l'Education Physique de Sfax, Université de Sfax, Sfax 3000, Tunisia.""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hakim', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Medicine, Sfax University, Sfax 3029, Tunisia.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': ""Institut Supérieur du Sport et de l'Education Physique de Sfax, Université de Sfax, Sfax 3000, Tunisia.""}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Driss', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical Activity, Health and Learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, 92000 Nanterre, France.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hoekelmann', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke-University Magdeburg, 39106 Magdeburg, Germany.'}, {'ForeName': 'Kais', 'Initials': 'K', 'LastName': 'El Abed', 'Affiliation': ""Institut Supérieur du Sport et de l'Education Physique de Sfax, Université de Sfax, Sfax 3000, Tunisia.""}]",International journal of environmental research and public health,['10.3390/ijerph17072601']
244,32167976,Effects of Inhaled Iloprost on Lung Mechanics and Myocardial Function During One-Lung Ventilation in Chronic Obstructive Pulmonary Disease Patients Combined With Poor Lung Oxygenation.,"BACKGROUND
The ventilation/perfusion mismatch in chronic obstructive pulmonary disease (COPD) patients can exacerbate cardiac function as well as pulmonary oxygenation. We hypothesized that inhaled iloprost can ameliorate pulmonary oxygenation with lung mechanics and myocardial function during one-lung ventilation (OLV) in COPD patients combined with poor lung oxygenation.
METHODS
A total of 40 patients with moderate to severe COPD, who exhibited the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FIO2) <150 mm Hg 30 minutes after initiating OLV, were enrolled in this study. Patients were randomly allocated into either ILO group (n = 20) or Control group (n = 20), in which iloprost (20 μg) and saline were inhaled, respectively. The PaO2/FIO2 ratio, dead space, dynamic compliance, and tissue Doppler imaging with myocardial performance index (MPI) were assessed 30 minutes after initiating OLV (pre-Tx) and 30 minutes after completion of drug inhalation (post-Tx). Repeated variables were analyzed using a linear mixed-model between the groups.
RESULTS
At pre-Tx, no differences were observed in measured parameters between the groups. At post-Tx, PaO2/FIO2 ratio (P < .001) and dynamic compliance (P = .023) were significantly higher and dead space ventilation was significantly lower (P = .001) in iloprost group (ILO group) compared to Control group. Left (P = .003) and right ventricular MPIs (P < .001) significantly decreased in ILO group compared to Control group.
CONCLUSIONS
Inhaled iloprost improved pulmonary oxygenation, lung mechanics, and cardiac function simultaneously during OLV in COPD patients with poor lung oxygenation.",2020,"Left (P = .003) and right ventricular MPIs (P < .001) significantly decreased in ILO group compared to Control group.
","['COPD patients combined with poor lung oxygenation', 'COPD patients with poor lung oxygenation', 'chronic obstructive pulmonary disease (COPD) patients', '40 patients with moderate to severe COPD, who exhibited the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FIO2) <150 mm', 'Chronic Obstructive Pulmonary Disease Patients Combined With Poor Lung Oxygenation', 'Hg 30 minutes after initiating OLV']","['ILO', 'iloprost', 'Inhaled Iloprost', 'inhaled iloprost', 'Inhaled iloprost', 'iloprost (20 μg) and saline']","['Lung Mechanics and Myocardial Function', 'right ventricular MPIs', 'pulmonary oxygenation, lung mechanics, and cardiac function simultaneously', 'pulmonary oxygenation with lung mechanics and myocardial function', 'PaO2/FIO2 ratio', 'PaO2/FIO2 ratio, dead space, dynamic compliance, and tissue Doppler imaging with myocardial performance index (MPI', 'dead space ventilation', 'dynamic compliance']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}]","[{'cui': 'C0079594', 'cui_str': 'Iloprost'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance (observable entity)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]",40.0,0.0179437,"Left (P = .003) and right ventricular MPIs (P < .001) significantly decreased in ILO group compared to Control group.
","[{'ForeName': 'Namo', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Su Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei Sarang Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Youngeun', 'Initials': 'Y', 'LastName': 'Joe', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Taelim', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Heesoo', 'Initials': 'H', 'LastName': 'Shin', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young Jun', 'Initials': 'YJ', 'LastName': 'Oh', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004733']
245,32110882,Role of Ketamine in Multimodal Analgesia Protocol for Bariatric Surgery.,"Background and Objectives: Acute postoperative pain is one of the most undesirable experiences for a patient in the postoperative period. Many options are available for the treatment of postoperative pain. One of the methods of multimodal analgesia is a combination of opioids and adjuvant agents, such as ketamine. The aim of this study was to evaluate the effect of a pre-incisional single injection of low-dose ketamine on postoperative pain after remifentanil infusion in patients undergoing laparoscopic gastric bypass or gastric plication surgery. Materials and Methods: The prospective, randomized, double-blinded and placebo-controlled trial took place at the Hospital of the Lithuanian University of Health sciences KaunoKlinikos in 2015-2017. A total of 32 bariatric patients (9 men and 23 women) were randomly assigned to receive a single pre-incisional injection of ketamine (0.15 mg/kg (LBM)) (ketamine, K group) or saline (placebo, S group). Standardized protocol of anesthesia and postoperative pain management was followed for all patients. Postoperative pain intensity, postoperative morphine requirements, incidence of side effects and patients' satisfaction with postoperative analgesia were recorded. Results: Thirty-two patients undergoing bariatric surgery: 18 (56.25%; gastric bypass) and 14 (43.75%; gastric plication) were examined. Both groups did not differ in demographic values, duration of surgery and anesthesia and intraoperative drug consumption. Postoperative pain scores were similar in both groups ( p = 0.105-0.941). Morphine consumption was 10.0 (7.0-12.5 mg) in group S and 9.0 (3.0-15.0 mg) in group K ( p = 0.022). The incidence of side effects was similar in both groups ( p = 0.412). Both groups demonstrated very high satisfaction with postoperative analgesia. Conclusions: Pre-incisional single dose ketamine reduces postoperative opioids consumption, but does not have an effect of postoperative pain intensity and side effects after remifentanil infusions. Very high patient satisfaction is achieved if standard multimodal analgesia protocol with an individual assessment of pain and dosage of medications is followed.",2020,The incidence of side effects was similar in both groups ( p = 0.412).,"['Results: Thirty-two patients undergoing bariatric surgery: 18 (56.25%; gastric bypass) and 14 (43.75%; gastric plication', 'Bariatric Surgery', '32 bariatric patients (9 men and 23 women', 'patients undergoing laparoscopic gastric bypass or gastric plication surgery', 'Hospital of the Lithuanian University of Health sciences KaunoKlinikos in 2015-2017']","['Ketamine', 'ketamine, K group) or saline (placebo', 'placebo', 'ketamine', 'remifentanil infusion', 'pre-incisional single injection of low-dose ketamine', 'single pre-incisional injection of ketamine (0.15 mg/kg (LBM']","['demographic values, duration of surgery and anesthesia and intraoperative drug consumption', 'postoperative pain intensity and side effects', 'Acute postoperative pain', 'postoperative pain', 'Postoperative pain scores', 'incidence of side effects', 'Morphine consumption', ""Postoperative pain intensity, postoperative morphine requirements, incidence of side effects and patients' satisfaction with postoperative analgesia""]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4039248', 'cui_str': 'Laparoscopic bypass of stomach'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",32.0,0.351183,The incidence of side effects was similar in both groups ( p = 0.412).,"[{'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Kasputytė', 'Affiliation': 'Department of Anaesthesiology, Lithuanian University of Health Sciences, 50161 Kaunas, Lithuania.'}, {'ForeName': 'Aurika', 'Initials': 'A', 'LastName': 'Karbonskienė', 'Affiliation': 'Department of Anaesthesiology, Lithuanian University of Health Sciences, 50161 Kaunas, Lithuania.'}, {'ForeName': 'Andrius', 'Initials': 'A', 'LastName': 'Macas', 'Affiliation': 'Department of Anaesthesiology, Lithuanian University of Health Sciences, 50161 Kaunas, Lithuania.'}, {'ForeName': 'Almantas', 'Initials': 'A', 'LastName': 'Maleckas', 'Affiliation': 'Department of Surgery, Lithuanian University of Health Sciences, 50161 Kaunas, Lithuania.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56030096']
246,32268897,"Clinical and cost-effectiveness of oral sodium bicarbonate therapy for older patients with chronic kidney disease and low-grade acidosis (BiCARB): a pragmatic randomised, double-blind, placebo-controlled trial.","BACKGROUND
Chronic kidney disease with metabolic acidosis is common in older people, but the effectiveness of oral sodium bicarbonate therapy in this group is unclear. We tested whether oral sodium bicarbonate provides net health benefit for older people with advanced chronic kidney disease and serum bicarbonate concentrations < 22 mmol/L.
METHODS
Pragmatic multicentre, parallel group, double-blind, placebo-controlled randomised trial. We recruited adults aged ≥ 60 years with estimated glomerular filtration rate of < 30 mL/min/1.73 m 2 , not receiving dialysis, with serum bicarbonate concentration < 22 mmol/L, from 27 nephrology and geriatric medicine departments in the UK. Participants received oral sodium bicarbonate (up to 3 g/day) or matching placebo given for up to 2 years, randomised in a 1:1 ratio. The primary outcome was between-group difference in the Short Physical Performance Battery (SPPB) at 12 months, adjusted for baseline values, analysed by intention to treat. Secondary outcomes included generic and disease-specific quality of life (EQ-5D and KDQoL tools), anthropometry, renal function, walk distance, blood pressure, bone and vascular health markers, and incremental cost per quality-adjusted life year gained.
RESULTS
We randomised 300 participants between May 2013 and February 2017, mean age 74 years, 86 (29%) female. At 12 months, 116/152 (76%) participants allocated to bicarbonate and 104/148 (70%) allocated to placebo were assessed; primary outcome data were available for 187 participants. We found no significant treatment effect for the SPPB: bicarbonate arm 8.3 (SD 2.5) points, placebo arm 8.8 (SD 2.2) and adjusted treatment effect - 0.4 (95% CI - 0.9 to 0.1, p = 0.15). We found no significant treatment effect for glomerular filtration rate (0.6 mL/min/1.73 m 2 , 95% CI - 0.8 to 2.0, p = 0.39). The bicarbonate arm showed higher costs and lower quality of life as measured by the EQ-5D-3L tool over 1 year (£564 [95% CI £88 to £1154]); placebo dominated bicarbonate under all sensitivity analyses. Adverse events were more frequent in those randomised to bicarbonate (457 versus 400).
CONCLUSIONS
Oral sodium bicarbonate did not improve physical function or renal function, increased adverse events and is unlikely to be cost-effective for use by the UK NHS for this patient group.
TRIAL REGISTRATION
European Clinical Trials Database (2011-005271-16) and ISRCTN09486651; registered 17 February 2012.",2020,The bicarbonate arm showed higher costs and lower quality of life as measured by the EQ-5D-3L tool over 1 year (£564 [95% CI £88 to £1154]); placebo dominated bicarbonate under all sensitivity analyses.,"['older people with advanced chronic kidney disease and serum bicarbonate concentrations <\u200922\u2009mmol/L', 'older patients with chronic kidney disease and low-grade acidosis (BiCARB', '300 participants between May 2013 and February 2017, mean age 74\u2009years, 86 (29%) female', 'We recruited adults aged ≥\u200960\u2009years with estimated glomerular filtration rate of <\u200930\u2009mL']","['sodium bicarbonate therapy', 'matching placebo', 'oral sodium bicarbonate', 'placebo', 'bicarbonate', 'SPPB: bicarbonate', 'Oral sodium bicarbonate', 'oral sodium bicarbonate therapy']","['generic and disease-specific quality of life (EQ-5D and KDQoL tools), anthropometry, renal function, walk distance, blood pressure, bone and vascular health markers, and incremental cost per quality-adjusted life year gained', 'glomerular filtration rate', 'Short Physical Performance Battery (SPPB', 'adverse events', 'physical function or renal function', 'Adverse events', 'higher costs and lower quality of life']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}]","[{'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",300.0,0.705714,The bicarbonate arm showed higher costs and lower quality of life as measured by the EQ-5D-3L tool over 1 year (£564 [95% CI £88 to £1154]); placebo dominated bicarbonate under all sensitivity analyses.,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC medicine,['10.1186/s12916-020-01542-9']
247,32151101,Different Treatments in Patients with Temporomandibular Joint Disorders: A Comparative Randomized Study.,"BACKGROUND AND OBJECTIVES
Temporomandibular joint disorders (TMJDs) are associated with pain and reduced jaw mobility. The aim of this study was to compare the outcome of patients with TMJ arthralgia when submitted to four different treatment modalities, in some cases using intra-articular injections of substances with anti-inflammatory properties and in others, a more conservative approach consisting only of a bite splint. Materials and Methods: The sample was made up of 80 patients, randomly distributed into 4 groups of 20 patients each. Each patient was given a nocturnal bite splint. One of the groups was treated with the bite splint only, while each patient in the other 3 was injected with betamethasone, sodium hyaluronate, or platelet-rich plasma in addition to using the bite splint. Two variables were assessed, namely pain intensity between 0 to 10 according to the visual analogue scale and maximum pain-free mouth opening in mm. The patients were evaluated at four different points: at the beginning of the treatment, as well as one week, one month and six months after initiation.
RESULTS
The results showed that maximum pain-free mouth opening improved in all the groups that made up the sample, with either a reduction in pain severity or with no pain. However, the group injected with platelet-rich plasma yielded the best results after six months, while patients treated with sodium hyaluronate or betamethasone obtained the best results at the end of the first week.
CONCLUSIONS
We concluded that all the treatments used caused a reduction in pain and increased pain-free mouth opening. The splint combined with the platelet-rich plasma injection achieved long-term success.",2020,"The results showed that maximum pain-free mouth opening improved in all the groups that made up the sample, with either a reduction in pain severity or with no pain.","['patients with TMJ arthralgia', 'Patients with Temporomandibular Joint Disorders']","['betamethasone, sodium hyaluronate, or platelet-rich plasma in addition to using the bite splint', 'Materials and Methods', 'sodium hyaluronate or betamethasone', 'nocturnal bite splint']","['maximum pain-free mouth opening', 'visual analogue scale and maximum pain-free mouth opening in mm', 'namely pain intensity', 'pain and increased pain-free mouth opening', 'pain severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039493', 'cui_str': 'TMJ'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}]","[{'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0087000', 'cui_str': 'Sodium Hyaluronate'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0005658', 'cui_str': 'Bites'}, {'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}]","[{'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",2.0,0.0180186,"The results showed that maximum pain-free mouth opening improved in all the groups that made up the sample, with either a reduction in pain severity or with no pain.","[{'ForeName': 'Bruno Macedo De', 'Initials': 'BM', 'LastName': 'Sousa', 'Affiliation': 'Institute for Occlusion and Orofacial Pain Faculty of Medicine, University of Coimbra, Polo I-Edifício Central Rua Larga, 3004-504 Coimbra, Portugal.'}, {'ForeName': 'Nansi', 'Initials': 'N', 'LastName': 'López-Valverde', 'Affiliation': 'Department of Surgery. University of Salamanca, Salamanca, Spain. Instituto de Investigación Biomédica de Salamanca (IBSAL), Avda. Alfonso X El Sabio S/N. 37007, Salamanca, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'López-Valverde', 'Affiliation': 'Department of Surgery. University of Salamanca, Salamanca, Spain. Instituto de Investigación Biomédica de Salamanca (IBSAL), Avda. Alfonso X El Sabio S/N. 37007, Salamanca, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Caramelo', 'Affiliation': 'Laboratory of Biostatistics and Medical Informatics, Coimbra. Institute for Clinical and Biomedical Research (iCBR), School of Medicine, University of Coimbra, Polo 3, Azinhaga de Santa Comba, Celas 3000-548 Coimbra, Portugal.'}, {'ForeName': 'Javier Flores', 'Initials': 'JF', 'LastName': 'Fraile', 'Affiliation': 'Department of Surgery. University of Salamanca, Salamanca, Spain. Instituto de Investigación Biomédica de Salamanca (IBSAL), Avda. Alfonso X El Sabio S/N. 37007, Salamanca, Spain.'}, {'ForeName': 'Julio Herrero', 'Initials': 'JH', 'LastName': 'Payo', 'Affiliation': 'Department of Surgery. University of Salamanca, Salamanca, Spain. Instituto de Investigación Biomédica de Salamanca (IBSAL), Avda. Alfonso X El Sabio S/N. 37007, Salamanca, Spain.'}, {'ForeName': 'María João', 'Initials': 'MJ', 'LastName': 'Rodrigues', 'Affiliation': 'Institute for Occlusion and Orofacial Pain Faculty of Medicine, University of Coimbra, Polo I-Edifício Central Rua Larga, 3004-504 Coimbra, Portugal.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56030113']
248,31696369,Crystal Clear with Active Visualization: Understanding Medication Adherence Among Youth Living with HIV.,"Adherence to antiretroviral therapy (ART) among youth remains low. We piloted an adapted active visualization device that demonstrates how ART works in the body. Youth living with HIV were randomized to: (1) standard care (n = 14) or the (2) adapted active visualization intervention (n = 14) and 71% of the sample (n = 19) were re-assessed on viral load, adherence behaviors, and illness perceptions 2.5 months later. Intervention youth had lower viral loads, reported less difficulty in adhering to ART, and more motivation and control over their HIV than standard care at follow-up. Active visualization may be an acceptable tool to address ART adherence among youth.",2020,"Intervention youth had lower viral loads, reported less difficulty in adhering to ART, and more motivation and control over their HIV than standard care at follow-up.","['Youth living with HIV', 'Youth Living with HIV']","['antiretroviral therapy (ART', 'Crystal Clear with Active Visualization', 'standard care (n\u2009=\u200914) or the (2) adapted active visualization intervention']",['lower viral loads'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0427896', 'cui_str': 'Crystal - human material (substance)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",,0.0618946,"Intervention youth had lower viral loads, reported less difficulty in adhering to ART, and more motivation and control over their HIV than standard care at follow-up.","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Christodoulou', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, Semel Institute, University of California Los Angeles, 10920, Wilshire Blvd., Suite 350, Los Angeles, CA, 90024, USA. JChristodoulou@mednet.ucla.edu.'}, {'ForeName': 'Sue Ellen', 'Initials': 'SE', 'LastName': 'Abdalian', 'Affiliation': 'School of Medicine, Tulane University, 1430 Tulane Ave, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Annie S K', 'Initials': 'ASK', 'LastName': 'Jones', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Christodoulou', 'Affiliation': 'Keck School of Medicine, University of Southern California, 1975 Zonal Ave, Los Angeles, CA, 90033, USA.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Pentoney', 'Affiliation': 'Organovo, Inc., San Diego, CA, USA.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Rotheram-Borus', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, Semel Institute, University of California Los Angeles, 10920, Wilshire Blvd., Suite 350, Los Angeles, CA, 90024, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02721-3']
249,32289310,Regular Bleeding Risk Assessment Associated with Reduction in Bleeding Outcomes: The mAFA-II Randomized Trial.,"BACKGROUND
The mobile atrial fibrillation application (mAFA-II) randomized trial reported that a holistic management strategy supported by mobile health reduced atrial fibrillation-related adverse outcomes. The present study aimed to assess whether regular reassessment of bleeding risk using the Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile international normalized ratio, Elderly, Drugs or alcohol (HAS-BLED) score would improve bleeding outcomes and oral anticoagulant (OAC) uptake.
METHODS
Bleeding risk (HAS-BLED score) was monitored prospectively using mAFA, and calculated as 30 days, days 31-60, days 61-180, and days 181-365. Clinical events and OAC changes in relation to the dynamic monitoring were analyzed.
RESULTS
We studied 1793 patients with atrial fibrillation (mean, standard deviation, age 64 years, 24 years, 32.5% female). Comparing baseline and 12 months, the proportion of atrial fibrillation patients with HAS-BLED ≥3 decreased (11.8% vs 8.5%, P = .008), with changes in use of concomitant nonsteroidal antiinflammatory drugs/antiplatelets, renal dysfunction, and labile international normalized ratio contributing to the decreased proportions of patients with HAS-BLED ≥3 (P < .05). Among 1077 (60%) patients who had 4 bleeding risk assessments, incident bleeding events decreased significantly from days 1-30 to days 181-365 (1.2% to 0.2%, respectively, P < .001). Total OAC usage increased from 63.4% to 70.2% (P trend < .001). Compared with atrial fibrillation patients receiving usual care (n = 1136), bleeding events were significantly lower in atrial fibrillation patients with dynamic monitoring of their bleeding risk (mAFA vs usual care, 2.1%, 4.3%, P = .004). OAC use decreased significantly by 25% among AF patients receiving usual care, when comparing baseline to 12 months (P < .001).
CONCLUSION
Dynamic risk monitoring using the HAS-BLED score, together with holistic App-based management using mAFA-II reduced bleeding events, addressed modifiable bleeding risks, and increased uptake of OACs.",2020,Total OAC usage increased from 63.4% to 70.2% (p trend <0.001).,"['1793 patients with atrial fibrillation (mean, standard deviation, age 64, 24 years, 32.5% female']",[],"['bleeding risk assessments, incident bleeding events', 'bleeding events', 'Total OAC usage', 'bleeding outcomes', 'atrial fibrillation-related adverse outcomes', 'proportion of atrial fibrillation patients with HAS-BLED ≥3', 'bleeding outcomes and anticoagulant (OAC) uptake', 'uptake of OACs', 'Bleeding risk (HAS-BLED score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3875442', 'cui_str': 'Hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly over 65, and drugs/alcohol concomitantly score'}]",1793.0,0.0308183,Total OAC usage increased from 63.4% to 70.2% (p trend <0.001).,"[{'ForeName': 'Yutao', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Medical School of Chinese PLA, Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Deirdre A', 'Initials': 'DA', 'LastName': 'Lane', 'Affiliation': 'Liverpool Centre for Cardiovascular Sciences, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Yundai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Medical School of Chinese PLA, Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Medical School of Chinese PLA, Department of Cardiology, Chinese PLA General Hospital, Beijing, China; Liverpool Centre for Cardiovascular Sciences, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: gregory.lip@liverpool.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of medicine,['10.1016/j.amjmed.2020.03.019']
250,31292531,One-year postpartum anthropometric outcomes in mothers and children in the LIFE-Moms lifestyle intervention clinical trials.,"BACKGROUND/OBJECTIVES
Excess gestational weight gain (GWG) is a risk factor for maternal postpartum weight retention and excessive neonatal adiposity, especially in women with overweight or obesity. Whether lifestyle interventions to reduce excess GWG also reduce 12-month maternal postpartum weight retention and infant weight-for-length z score is unknown. Randomized controlled trials from the LIFE-Moms consortium investigated lifestyle interventions that began in pregnancy and tested whether there was benefit through 12 months on maternal postpartum weight retention (i.e., the difference in weight from early pregnancy to 12 months) and infant-weight-for-length z scores.
SUBJECTS/METHODS
In LIFE-Moms, women (N = 1150; 14.1 weeks gestation at enrollment) with overweight or obesity were randomized within each of seven trials to lifestyle intervention or standard care. Individual participant data were combined and analyzed using generalized linear mixed models with trial entered as a random effect. The 12-month assessment was completed by 83% (959/1150) of women and 84% (961/1150) of infants.
RESULTS
Compared with standard care, lifestyle intervention reduced postpartum weight retention (2.2 ± 7.0 vs. 0.7 ± 6.2 kg, respectively; difference of -1.6 kg (95% CI -2.5, -0.7; p = 0.0003); the intervention effect was mediated by reduction in excess GWG, which explained 22% of the effect on postpartum weight retention. Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care. There was no statistically significant treatment group effect on infant anthropometric outcomes at 12 months.
CONCLUSIONS
Compared with standard care, lifestyle interventions initiated in pregnancy and focused on healthy eating, increased physical activity, and other behavioral strategies resulted in significantly less weight retention but similar infant anthropometric outcomes at 12 months postpartum in a large, diverse US population of women with overweight and obesity.",2020,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","['women (N\u2009=\u20091150; 14.1 weeks gestation at enrollment) with overweight or obesity', 'mothers and children in the LIFE-Moms lifestyle intervention clinical trials', 'women with overweight or obesity']","['lifestyle intervention or standard care', 'LIFE-Moms consortium investigated lifestyle interventions']","['maternal postpartum weight retention and infant weight-for-length z score', 'infant anthropometric outcomes', 'weight retention', 'infant-weight-for-length z scores', 'postpartum weight retention', 'maternal postpartum weight retention']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4704811', 'cui_str': 'Postpartum Weight Retention'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",1150.0,0.182381,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Department of Kinesiology & Public Health, California Polytechnic State University, San Luis Obispo, CA, USA. sphelan@calpoly.edu.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Clifton', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Haire-Joshu', 'Affiliation': 'Center for Diabetes Translation Research, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Kaumudi', 'Initials': 'K', 'LastName': 'Joshipura', 'Affiliation': 'Center for Clinical Research and Health Promotion, School of Dental Medicine, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Couch', 'Affiliation': 'Phoenix Indian Medical Center, Indian Health Service, Phoenix, AZ, USA.'}, {'ForeName': 'S Sonia', 'Initials': 'SS', 'LastName': 'Arteaga', 'Affiliation': 'The National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Drews', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan Public Health School, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Dympna', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Jami L', 'Initials': 'JL', 'LastName': 'Josefson', 'Affiliation': 'Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Center for Human Nutrition, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'The Miriam Hospital and the Department of Psychiatry and Human Behavior, Warren Alpert Medical School at Brown University, Providence, RI, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of obesity (2005),['10.1038/s41366-019-0410-4']
251,31350585,Recovery and prognostic value of myocardial strain in ST-segment elevation myocardial infarction patients with a concurrent chronic total occlusion.,"OBJECTIVES
Global left ventricular (LV) function is routinely used to assess cardiac function; however, myocardial strain is able to identify more subtle dysfunction. We aimed to determine the recovery and prognostic value of featuring tracking (FT) cardiovascular magnetic resonance (CMR) strain in ST-segment elevation myocardial infarction (STEMI) patients with a concurrent chronic total occlusion (CTO).
METHODS
In the randomized EXPLORE trial, there was no significant difference in global LV function after percutaneous coronary intervention (PCI) of the CTO, compared with no-CTO PCI, post-STEMI. In the current study, we included 200 of the 302 EXPLORE patients with a baseline CMR, of which 180 also had 4-month follow-up (serial) CMR. Global longitudinal strain (GLS) was calculated from 3 long-axis views. Global circumferential strain (GCS) and segmental strain were calculated from 3 short-axis views (basal, mid, and apical).
RESULTS
Global strain significantly improved at 4 months (GLS ∆ - 1.8 ± 4.3%, p < 0.001; GCS ∆ - 1.7 ± 4.7%, p < 0.001); however, there was no treatment effect of CTO-PCI on strain recovery. GLS was a significant predictor for 4 months of LV ejection fraction (p = 0.006), incremental to other CMR parameters including infarct size. For mortality, infarct size remained the strongest predictor. On regional level, segmental strain independently predicted recovery in the dysfunctional segments (p < 0.001).
CONCLUSIONS
Global and segmental myocardial strains significantly improved over time, with no effect of CTO-PCI. Global strain was associated with outcome and segmental strain was an independent predictor for regional LV recovery in the dysfunctional CTO territory. Further research is needed to determine the additional prognostic value of strain beyond routine CMR parameters.
KEY POINTS
• In STEMI patients with a concurrent CTO, strain significantly improves over time, regardless of CTO-PCI. • Global strain is an independent predictor for functional recovery, incremental to infarct size, LVEF, and clinical parameters. • Segmental strain was able to predict the recovery of wall thickening, incremental to transmural extent of infarction.",2020,Global strain was associated with outcome and segmental strain was an independent predictor for regional LV recovery in the dysfunctional CTO territory.,"['ST-segment elevation myocardial infarction patients with a concurrent chronic total occlusion', '200 of the 302 EXPLORE patients with a baseline CMR, of which 180 also had 4-month follow-up (serial) CMR', 'ST-segment elevation myocardial infarction (STEMI) patients with a concurrent chronic total occlusion (CTO']",['featuring tracking (FT) cardiovascular magnetic resonance (CMR) strain'],"['Global strain', 'Global circumferential strain (GCS) and segmental strain', 'global LV function', 'Global longitudinal strain (GLS', 'LV ejection fraction']","[{'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",302.0,0.0840994,Global strain was associated with outcome and segmental strain was an independent predictor for regional LV recovery in the dysfunctional CTO territory.,"[{'ForeName': 'Joëlle', 'Initials': 'J', 'LastName': 'Elias', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. j.elias@amsterdamumc.nl.'}, {'ForeName': 'Ivo M', 'Initials': 'IM', 'LastName': 'van Dongen', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Loes P', 'Initials': 'LP', 'LastName': 'Hoebers', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Dagmar M', 'Initials': 'DM', 'LastName': 'Ouweneel', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Bimmer E P M', 'Initials': 'BEPM', 'LastName': 'Claessen', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Råmunddal', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Peep', 'Initials': 'P', 'LastName': 'Laanmets', 'Affiliation': 'North Estonia Medical Center, Tallinn, Estonia.'}, {'ForeName': 'Erlend', 'Initials': 'E', 'LastName': 'Eriksen', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'René J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ioanes', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Nijveldt', 'Affiliation': 'University Medical Center St Radboud, Nijmegen, The Netherlands.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'José P S', 'Initials': 'JPS', 'LastName': 'Henriques', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hirsch', 'Affiliation': 'Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European radiology,['10.1007/s00330-019-06338-x']
252,32290266,SettleIN: Using a Manualised Intervention to Facilitate the Adjustment of Older Adults with Dementia Following Placement into Residential Care.,"The authors examined the feasibility of delivering an adapted version of SettleIN, a manualised staff-led programme designed to facilitate adjustment to care for new residents with dementia. The effects of SettleIN on resident adjustment, mood and quality of life were also investigated. A pilot randomised controlled trial was conducted. Nineteen new residents with dementia and 21 staff participants were recruited. Residents were randomly assigned to receive the SettleIN programme or residential care as usual. Resident quality of life, mood and overall adjustment were measured at baseline and post-intervention, in week seven. Interviews were conducted with staff in week seven to explore intervention feasibility. Despite medium to large effect sizes, there was no significant difference in mean change scores between the two conditions, with regards to quality of life, psychological wellbeing or overall adjustment outcomes. Qualitative feedback indicated that SettleIN was not feasible across all areas, with problems around recruitment and practicality. However, SettleIN was deemed feasible in terms of retention and acceptability among staff. The majority of staff felt that SettleIN was beneficial for residents but that organisational and programme factors impacted upon intervention feasibility. Further exploration of organisational barriers is needed in order to reduce the impact of such factors on care home research.",2020,"Despite medium to large effect sizes, there was no significant difference in mean change scores between the two conditions, with regards to quality of life, psychological wellbeing or overall adjustment outcomes.","['new residents with dementia', 'Nineteen new residents with dementia and 21 staff participants were recruited', 'Older Adults with Dementia Following Placement into Residential Care']","['SettleIN programme or residential care as usual', 'Manualised Intervention']","['quality of life, psychological wellbeing or overall adjustment outcomes', 'mean change scores', 'Resident quality of life, mood and overall adjustment', 'resident adjustment, mood and quality of life']","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.089169,"Despite medium to large effect sizes, there was no significant difference in mean change scores between the two conditions, with regards to quality of life, psychological wellbeing or overall adjustment outcomes.","[{'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Saint-Bryant', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London WC1E 7HB, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Murrill', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London WC1E 7HB, UK.'}, {'ForeName': 'Janine K', 'Initials': 'JK', 'LastName': 'Hayward', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London WC1E 7HB, UK.'}, {'ForeName': 'Kayleigh-Marie', 'Initials': 'KM', 'LastName': 'Nunez', 'Affiliation': 'Wolfson Centre for Age Related Diseases, Kings College London, Wolfson Wing, Hodgkin Building, Guys Campus, London SE1 1UL, UK.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Spector', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London WC1E 7HB, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17072606']
253,31385047,No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial.,"OBJECTIVE
To investigate whether covered stents show a higher efficacy than uncovered stents in percutaneous treatment of malignant hilar biliary obstruction.
METHODS
Patients with obstructive jaundice caused by an unresectable hilar malignancy were included after failed endoscopic intervention in a prospective randomized trial comparing expanded polytetrafluoroethylene and fluorinated ethylene propylene (ePTFE-FEP)-covered nitinol stents with uncovered nitinol stents. Exclusion criteria were as follows: primary tumors existing more than 3 months, a biliodigestive anastomosis, previous stenting, and a Karnofsky score of less than 50. Safety, clinical success, and adjuvant chemotherapy were compared as well as occlusion rate, patency, and survival.
RESULTS
A total of 120 patients were included. One patient was post hoc excluded. Fourteen patients who died within 7 days and one patient without patency data were excluded from patency analysis. Serious adverse events (p = 0.4), 30-day mortality (p = 0.5), and clinical success (p = 0.8) were equivalent for both stent groups. Twenty-one out of 61 (34%) patients in the covered and 24/58 (41%) in the uncovered stent groups received adjuvant chemotherapy (p = 0.5). Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8). Median patency was 229 days (95% CI 113-345) for covered stents and 130 days (95% CI 75-185) for uncovered stents (p = 0.1). Median survival in patients with covered stents was 79 days (95% CI 52-106) and with uncovered stents 92 days (95% CI 60-124) (p = 0.3).
CONCLUSION
In malignant hilar biliary obstruction, there is no evidence that ePTFE-FEP-covered stents are superior to uncovered stents in terms of safety, clinical success, adjuvant chemotherapy, patency, or survival.
KEY POINTS
• Percutaneous palliation of hilar biliary obstruction is feasible with both uncovered and covered stents. • Clinical success in terms of bilirubin decrease and adjuvant chemotherapy is achievable with both stents. • Thirty-day mortality is considerable when stenting is also offered to patients with a low performance status.",2020,Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8).,"['A total of 120 patients were included', 'Exclusion criteria were as follows: primary tumors existing more than 3\xa0months, a biliodigestive anastomosis, previous stenting, and a Karnofsky score of less than 50', 'percutaneous palliation of malignant hilar biliary obstruction', 'Patients with obstructive jaundice caused by an unresectable hilar malignancy were included after failed']","['adjuvant chemotherapy', 'expanded polytetrafluoroethylene and fluorinated ethylene propylene (ePTFE-FEP)-covered nitinol stents with uncovered nitinol stents', 'endoscopic intervention']","['Median survival', 'Safety, clinical success, and adjuvant chemotherapy', 'Occlusion rate', 'occlusion rate, patency, and survival', 'clinical success', 'Serious adverse events', 'Median patency', '30-day mortality', 'safety, clinical success, adjuvant chemotherapy, patency, or survival']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0022354', 'cui_str': 'Jaundice, Obstructive'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0382943', 'cui_str': 'poly(tetrafluoroethylene-co-hexafluoropropylene)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0068790', 'cui_str': 'nickel titanium'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",120.0,0.277257,Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8).,"[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Dhondt', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium. elisabeth.dhondt@uzgent.be.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vanlangenhove', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Geboes', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Vandenabeele', 'Affiliation': 'Department of Gastroenterology, Saint-Joseph Clinic Bornem and Willebroek, Bornem, Belgium.'}, {'ForeName': 'Lien', 'Initials': 'L', 'LastName': 'Van Cauwenberghe', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Defreyne', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}]",European radiology,['10.1007/s00330-019-06374-7']
254,32264828,A model to predict unstable carotid plaques in population with high risk of stroke.,"BACKGROUND
Several models have been developed to predict asymptomatic carotid stenosis (ACS), however these models did not pay much attention to people with lower level of stenosis (<50% or carotid plaques, especially instable carotid plaques) who might benefit from early interventions. Here, we developed a new model to predict unstable carotid plaques through systematic screening in population with high risk of stroke.
METHODS
Community residents who participated the China National Stroke Screening and Prevention Project (CNSSPP) were screened for their stroke risks. A total of 2841 individuals with high risk of stroke were enrolled in this study, 266 (9.4%) of them were found unstable carotid plaques. A total of 19 risk factors were included in this study. Subjects were randomly distributed into Derivation Set group or Validation Set group. According to their carotid ultrasonography records, subjects in derivation set group were further categorized into unstable plaque group or stable plaque group.
RESULTS
174 cases and 1720 cases from Derivation Set group were categorized into unstable plaque group and stable plaque group respectively. The independent risk factors for carotid unstable plaque were: male (OR 1.966, 95%CI 1.406-2.749), older age (50-59, OR 6.012, 95%CI 1.410-25.629; 60-69, OR 13.915, 95%CI 3.381-57.267;≥70, OR 31.267, 95%CI 7.472-130.83), married(OR 1.780, 95%CI 1.186-2.672), LDL-C(OR 2.015, 95%CI 1.443-2.814), and HDL-C(OR 2.130, 95%CI 1.360-3.338). A predictive scoring system was generated, ranging from 0 to 10. The cut-off value of this predictive scoring system is 6.5. The AUC value for derivation and validation set group were 0.738 and 0.737 respectively.
CONCLUSIONS
For those individuals with high risk of stroke, we developed a new model which could identify those who have a higher chance to have unstable carotid plaques. When an individual's predictive model score exceeds 6.5, the probability of having carotid unstable plaques is high, and carotid ultrasonography should be conducted accordingly. This model could be helpful in the primary prevention of stroke.",2020,"The independent risk factors for carotid unstable plaque were: male (OR 1.966, 95%CI 1.406-2.749), older age (50-59, OR 6.012, 95%CI 1.410-25.629; 60-69, OR 13.915, 95%CI 3.381-57.267;≥70, OR 31.267, 95%CI 7.472-130.83), married(OR 1.780, 95%CI 1.186-2.672), LDL-C(OR 2.015, 95%CI 1.443-2.814), and HDL-C(OR 2.130, 95%CI 1.360-3.338).","['individuals with high risk of stroke', 'Community residents who participated the China National Stroke Screening and Prevention Project (CNSSPP) were screened for their stroke risks', '2841 individuals with high risk of stroke were enrolled in this study, 266 (9.4%) of them were found unstable carotid plaques', 'population with high risk of stroke', 'A total of 19 risk factors', '174 cases and 1720 cases from Derivation Set group']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C4517603', 'cui_str': '1720'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],[],2841.0,0.078927,"The independent risk factors for carotid unstable plaque were: male (OR 1.966, 95%CI 1.406-2.749), older age (50-59, OR 6.012, 95%CI 1.410-25.629; 60-69, OR 13.915, 95%CI 3.381-57.267;≥70, OR 31.267, 95%CI 7.472-130.83), married(OR 1.780, 95%CI 1.186-2.672), LDL-C(OR 2.015, 95%CI 1.443-2.814), and HDL-C(OR 2.130, 95%CI 1.360-3.338).","[{'ForeName': 'Junxiong', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Department of Neurology, Brain Hospital Affiliated to Nanjing Medical University, 264# Guangzhou road, Nanjing, 210012, Jiangsu, China.'}, {'ForeName': 'Chuanyong', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, Brain Hospital Affiliated to Nanjing Medical University, 264# Guangzhou road, Nanjing, 210012, Jiangsu, China.'}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Brain Hospital Affiliated to Nanjing Medical University, 264# Guangzhou road, Nanjing, 210012, Jiangsu, China.'}, {'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Du', 'Affiliation': 'Department of Neurology, Brain Hospital Affiliated to Nanjing Medical University, 264# Guangzhou road, Nanjing, 210012, Jiangsu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Brain Hospital Affiliated to Nanjing Medical University, 264# Guangzhou road, Nanjing, 210012, Jiangsu, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Computer Science and Technology, Nanjing University, Nanjing, 210012, Jiangsu, China.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Department of Computer Science and Technology, Nanjing University, Nanjing, 210012, Jiangsu, China.'}, {'ForeName': 'Chongjun', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Computer Science and Technology, Nanjing University, Nanjing, 210012, Jiangsu, China.'}, {'ForeName': 'Xiaoshan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Brain Hospital Affiliated to Nanjing Medical University, 264# Guangzhou road, Nanjing, 210012, Jiangsu, China. professor_wxs@163.com.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01450-z']
255,32181677,Oral Vitamin D Supplementation to Mothers During Lactation-Effect of 25(OH)D Concentration on Exclusively Breastfed Infants at 6 Months of Age: A Randomized Double-Blind Placebo-Controlled Trial.,"Background: Exclusively breastfed infants are at risk of vitamin D deficiency. Objective: To find out proportion of exclusively breastfed infants having serum 25(OH)D concentration <11 ng/mL at 6 months of age with or without oral supplementation of vitamin D 3 to lactating mothers. Methods: Randomized placebo-controlled study included 132 mothers and infants divided into two groups. Mothers received either vitamin D 3 60,000 IU between 24 and 48 hours postpartum and at 6, 10, and 14 weeks amounting to 240,000 IU of vitamin D 3 or placebo. Serum 25(OH)D concentration in the mothers was measured at recruitment and that of infants, at birth and 6 months. Infants were evaluated for rickets at 6 months. Findings: Total 114 mother-infant dyads followed. Subjects in both groups were comparable in basic characteristics. At 6 months of age, serum 25(OH)D concentration in infants was 18.93 (5.12) ng/mL in the intervention group and 6.43 (3.76) ng/mL in the control group (mean difference = 12.5; 95% CI = 10.80-14.17; p < 0.001) and vitamin D deficiency and insufficiency was corrected in 93.1% and 38% infants, respectively, in the intervention group. There was no change in the vitamin D status of infants in the control group. In 60.3% infants (RR = 0.519; 95% CI = -0.485 to 0.735) of the intervention group 25(OH)D concentration was <20 ng/mL at 6 months of age. Six infants in the control group suffered from biochemical rickets. Radiological rickets developed in one infant in the intervention group and two infants in the control group. Conclusion: Serum 25(OH)D concentration of exclusively breastfed infants rise significantly when mothers are orally supplemented with 240,000 IU of vitamin D 3 during lactation in comparison with the infants of unsupplemented mothers with 94.6% and 48.1% reduction in the risk of vitamin D deficiency and insufficiency, respectively, at 6 months of age.",2020,In 60.3% infants (RR = 0.519; 95% CI = -0.485 to 0.735) of the intervention group 25(OH)D concentration was <20 ng/mL at 6 months of age.,"['Exclusively Breastfed Infants at 6 Months of Age', 'Mothers', '132 mothers and infants divided into two groups']","['vitamin D', 'placebo', 'Oral Vitamin D Supplementation', 'Placebo', 'vitamin D 3 or placebo']","['vitamin D status', 'serum 25(OH)D concentration', 'vitamin D deficiency and insufficiency', 'biochemical rickets', '25(OH)D concentration', 'Radiological rickets', 'Serum 25(OH)D concentration']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}, {'cui': 'C0458011', 'cui_str': 'Biochemical rickets (disorder)'}]",132.0,0.363656,In 60.3% infants (RR = 0.519; 95% CI = -0.485 to 0.735) of the intervention group 25(OH)D concentration was <20 ng/mL at 6 months of age.,"[{'ForeName': 'Maharshi', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Department of Pediatrics, University College of Medical Sciences and GTB Hospital, Delhi, India.'}, {'ForeName': 'Mohammad Moonis Akbar', 'Initials': 'MMA', 'LastName': 'Faridi', 'Affiliation': 'Department of Pediatrics, University College of Medical Sciences and GTB Hospital, Delhi, India.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Pediatrics, University College of Medical Sciences and GTB Hospital, Delhi, India.'}, {'ForeName': 'Sri Venkata', 'Initials': 'SV', 'LastName': 'Madhu', 'Affiliation': 'Department of Endocrinology, University College of Medical Sciences and GTB Hospital, Delhi, India.'}, {'ForeName': 'Rajiv Kumar', 'Initials': 'RK', 'LastName': 'Malhotra', 'Affiliation': 'Department of Biostatistics, University College of Medical Sciences and GTB Hospital, Delhi, India.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2019.0102']
256,31467447,"Parents of newborns in the NICU enrolled in genome sequencing research: hopeful, but not naïve.","PURPOSE
In 2014, our institution launched a randomized controlled trial (RCT) comparing rapid genome sequencing (GS) to standard clinical evaluations of infants with suspected genetic disorders. This study aimed to understand parental response to the use of GS for their newborn babies.
METHODS
Twenty-three of 128 parents whose infant had enrolled in the RCT completed a retrospective survey and interview addressing attitudes about GS and responses to receiving diagnostic information. We also collected information about participants' genetic literacy, genetic knowledge, numeracy, and symptoms of anxiety and depression.
RESULTS
The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial. The 12 participants who had received a unifying diagnosis for their child's symptoms described personal utility of the information. Some reported the diagnosis led to changes in medical care. Participants showed understanding of some of the psychological risks of GS. For example, 21 (91.3%) agreed or strongly agreed that genetic testing could reveal disturbing results.
CONCLUSIONS
Parents who enrolled their newborn in a RCT of GS demonstrated awareness of a psychological risk, but generally held positive beliefs about GS and perceived the benefits outweighed the risk.",2020,The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial.,"['infants with suspected genetic disorders', 'Twenty-three of 128 parents whose infant had enrolled in the RCT completed a retrospective survey and interview addressing attitudes about GS and responses to receiving diagnostic information', 'Parents of newborns in the NICU enrolled in genome sequencing research', ""12 participants who had received a unifying diagnosis for their child's symptoms described personal utility of the information""]",[],['psychological risks of GS'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0019247', 'cui_str': 'Hereditary Diseases'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0035168'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",128.0,0.0537586,The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial.,"[{'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Berrios', 'Affiliation': ""Center for Pediatric Genomic Medicine, Children's Mercy Kansas City, Kansas City, MO, USA. cdberrios@cmh.edu.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Koertje', 'Affiliation': ""Division of Developmental and Behavioral Sciences, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Noel-MacDonnell', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Soden', 'Affiliation': ""Center for Pediatric Genomic Medicine, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lantos', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-019-0644-5']
257,32279690,Resistant starch supplementation increases crypt cell proliferative state in the rectal mucosa of older healthy participants.,"There is strong evidence that foods containing dietary fibre protect against colorectal cancer, resulting at least in part from its anti-proliferative properties. This study aimed to investigate the effects of supplementation with two non-digestible carbohydrates, resistant starch (RS) and polydextrose (PD), on crypt cell proliferative state (CCPS) in the macroscopically normal rectal mucosa of healthy individuals. We also investigated relationships between expression of regulators of apoptosis and of the cell cycle on markers of CCPS. Seventy-five healthy participants were supplemented with RS and/or PD or placebo for 50 d in a 2 × 2 factorial design in a randomised, double-blind, placebo-controlled trial (the Dietary Intervention, Stem cells and Colorectal Cancer (DISC) Study). CCPS was assessed, and the expression of regulators of the cell cycle and of apoptosis was measured by quantitative PCR in rectal mucosal biopsies. SCFA concentrations were quantified in faecal samples collected pre- and post-intervention. Supplementation with RS increased the total number of mitotic cells within the crypt by 60 % (P = 0·001) compared with placebo. This effect was limited to older participants (aged ≥50 years). No other differences were observed for the treatments with PD or RS as compared with their respective controls. PD did not influence any of the measured variables. RS, however, increased cell proliferation in the crypts of the macroscopically-normal rectum of older adults. Our findings suggest that the effects of RS on CCPS are not only dose, type of RS and health status-specific but are also influenced by age.",2020,Supplementation with RS increased the total number of mitotic cells within the crypt by 60% (p=0.001) compared with placebo.,"['75 healthy participants', 'older participants (aged ≥50', 'older healthy participants', 'macroscopically-normal rectal mucosa of healthy individuals']","['RS and/or PD or placebo', 'supplementation with two non-digestible carbohydrates, resistant starch (RS) and polydextrose (PD', 'Resistant starch supplementation', 'placebo']","['expression of regulators of the cell cycle and of apoptosis', 'SCFA concentrations', 'total number of mitotic cells', 'crypt cell proliferative state (CCPS', 'cell proliferation', 'crypt cell proliferative state']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0227395', 'cui_str': 'Rectal mucous membrane structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0071545', 'cui_str': 'polydextrose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0230518', 'cui_str': 'Mitotic cell'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0596290', 'cui_str': 'Cellular Proliferation'}]",75.0,0.290488,Supplementation with RS increased the total number of mitotic cells within the crypt by 60% (p=0.001) compared with placebo.,"[{'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Malcomson', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon TyneNE2 4HH, UK.'}, {'ForeName': 'Naomi D', 'Initials': 'ND', 'LastName': 'Willis', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon TyneNE2 4HH, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'McCallum', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North ShieldsNE29 8NH, UK.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon TyneNE2 4HH, UK.'}, {'ForeName': 'Arthur C', 'Initials': 'AC', 'LastName': 'Ouwehand', 'Affiliation': 'DuPont Nutrition & Biosciences, 02460Kantvik, Finland.'}, {'ForeName': 'Julian D', 'Initials': 'JD', 'LastName': 'Stowell', 'Affiliation': 'DuPont Nutrition & Biosciences, ReigateRH2 9PQ, UK.'}, {'ForeName': 'Seamus', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North ShieldsNE29 8NH, UK.'}, {'ForeName': 'D Michael', 'Initials': 'DM', 'LastName': 'Bradburn', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, AshingtonNE63 9JJ, UK.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Belshaw', 'Affiliation': 'University of East Anglia, Norwich Research Park, NorwichNR4 7TJ, UK.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Johnson', 'Affiliation': 'Quadram Institute, Norwich Research Park, NorwichNR4 7UQ, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon TyneNE2 4HH, UK.'}]",The British journal of nutrition,['10.1017/S0007114520001312']
258,32151708,Changes in serum estrogenic activity during neoadjuvant therapy with letrozole and exemestane.,"The aromatase inhibitors (AIs), letrozole (Femar®/Femara®) and exemestane (Aromasin®), are widely used to treat estrogen receptor (ER) positive breast cancer in postmenopausal patients. In the setting of metastatic breast cancer, these drugs may be used after another causing new responses in selected patients after progressing on the first choice. The precise explanation for this ""lack of cross resistance"" is still missing. NEOLETEXE is a neoadjuvant, randomized, open-label, cross-over trial. Postmenopausal patients with ER-positive, HER-2 negative, locally advanced breast cancer were enrolled. All patients were randomized to treatment starting with either letrozole or exemestane for at least 2 months followed by another 2 months on the alternative AI. The total estrogenic activities in blood samples were determined using the AroER tri-screen assay developed in the Chen laboratory. Using this highly sensitive assay, estrogenic activity was detected at three time points for all patients. Importantly, a significantly higher total estrogenic activity was found during therapy with exemestane compared to letrozole in 21 out of 26 patients. When letrozole was included in the AroER tri-screen assay, the estrogenic activities in most samples collected during exemestane treatment were further reduced, suggesting that low levels of androgens remained in specimens obtained after exemestane treatment. Our results suggest the AroER tri-screen to be a very sensitive method to estimate the overall estrogen-mediated activity in human samples even during therapy with highly potent aromatase inhibitors. In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.",2020,"In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.","['postmenopausal patients', 'Postmenopausal patients with ER-positive, HER-2 negative, locally advanced breast cancer were enrolled']","['letrozole', 'letrozole and exemestane', 'aromatase inhibitors (AIs), letrozole (Femar®/Femara®) and exemestane (Aromasin®', 'letrozole or exemestane', 'exemestane']","['total estrogenic activities in blood samples', 'serum estrogenic activity', 'estrogenic activity', 'serum estrogen activity', 'total estrogenic activity', 'estrogenic activities']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0876723', 'cui_str': 'Aromasin'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0857965', 'cui_str': 'Serum oestrogen'}]",26.0,0.0127101,"In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.","[{'ForeName': 'Nazli', 'Initials': 'N', 'LastName': 'Bahrami', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway; Department of Breast and Endocrine Surgery, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Kanaya', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Torill', 'Initials': 'T', 'LastName': 'Sauer', 'Affiliation': 'Department of Pathology, Akershus University Hospital, Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Campus AHUS, Norway.'}, {'ForeName': 'Daehoon', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': 'Department of Pathology, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Loeng', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Gravdehaug', 'Affiliation': 'Department of Breast and Endocrine Surgery, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Shiuan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Geisler', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Campus AHUS, Norway. Electronic address: juergen.geisler@medisin.uio.no.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105641']
259,32077907,Assessment of the DRCR Retina Network Approach to Management With Initial Observation for Eyes With Center-Involved Diabetic Macular Edema and Good Visual Acuity: A Secondary Analysis of a Randomized Clinical Trial.,"Importance
Among eyes with center-involved diabetic macular edema (CI-DME) and good visual acuity (VA), randomized clinical trial results showed no difference in VA loss between initial observation plus aflibercept only if VA decreased, initial focal/grid laser plus aflibercept only if VA decreased, or prompt aflibercept. Understanding the initial observation approach is relevant to patient management.
Objective
To assess the DRCR Retina Network protocol-defined approach and outcomes of initial observation with aflibercept only if VA worsened.
Design, Setting, and Participants
This was a post hoc secondary analyses of a randomized clinical trial of the DRCR Retina Network Protocol V that included 91 US and Canadian sites from November 2013 to September 2018. Participants were adults (n = 236) with type 1 or 2 diabetes, 1 study eye with CI-DME, and VA letter score at least 79 (Snellen equivalent, 20/25 or better) assigned to initial observation. Data were analyzed from March 2019 to November 2019.
Interventions
Initial observation and follow-up with aflibercept only for VA loss of at least 10 letters from baseline at 1 visit or 5 to 9 letters at 2 consecutive visits. Follow-up occurred at 8 weeks and then every 16 weeks unless VA or optical coherence tomography central subfield thickness worsened.
Main Outcomes and Measures
Whether individuals received aflibercept.
Results
Among 236 eyes in 236 individuals (149 [63%] male; median age, 60 years [interquartile range, 53-67 years]) randomly assigned to initial observation, 80 (34%) were treated with aflibercept during 2 years of follow-up. At 2 years, the median VA letter score was 86.0 (interquartile range, 89.0-81.0; median Snellen equivalent, 20/20 [20/16-20/25]). Receipt of aflibercept was more likely in eyes with baseline central subfield thickness at least 300 μm (Zeiss-Stratus equivalent) vs less than 300 μm (45% vs 26%; hazard ratio [HR], 1.98 [95% CI, 1.26-3.13], continuous P = .005), moderately severe nonproliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study retinopathy severity level 47) and above vs moderate nonproliferative diabetic retinopathy (retinopathy severity level 43) and below (51% vs 27%; HR, 2.22 [95% CI, 1.42-3.47], ordinal P < .001), and among participants whose nonstudy eye received DME treatment within 4 months of randomization vs not (52% vs 25%; HR, 2.55 [95% CI, 1.64-3.99], P < .001).
Conclusions and Relevance
Most eyes managed with initial observation plus aflibercept only if VA worsened maintained good vision at 2 years and did not require aflibercept for VA loss. However, the eyes in the trial were approximately twice as likely to receive aflibercept for VA loss if they had greater baseline central subfield thickness, worse diabetic retinopathy severity level, or a nonstudy eye receiving treatment for DME.
Trial Registration
ClinicalTrials.gov Identifier: NCT01909791.",2020,"At 2 years, the median VA letter score was 86.0 (interquartile range, 89.0-81.0; median Snellen equivalent, 20/20 [20/16-20/25]).","['eyes with center-involved diabetic macular edema (CI-DME) and good visual acuity (VA', '236 eyes in 236 individuals (149 [63%] male; median age, 60 years [interquartile range, 53-67 years]) randomly assigned to initial observation, 80 (34%) were treated with', 'that included 91 US and Canadian sites from November 2013 to September 2018', 'Eyes', 'Participants were adults (n\u2009=\u2009236) with type 1 or 2 diabetes, 1 study eye with CI-DME, and VA letter score at least 79 (Snellen equivalent, 20/25 or better) assigned to initial observation']","['aflibercept', 'DRCR Retina Network Protocol V']","['VA loss', 'diabetic retinopathy severity level', 'moderately severe nonproliferative diabetic retinopathy', 'median VA letter score', 'nonproliferative diabetic retinopathy', 'Diabetic Macular Edema and Good Visual Acuity']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1690939', 'cui_str': '6/7.5'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0035298', 'cui_str': 'Retina'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0730278', 'cui_str': 'Severe nonproliferative retinopathy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004606', 'cui_str': 'NPDR - Non proliferative diabetic retinopathy'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",,0.325444,"At 2 years, the median VA letter score was 86.0 (interquartile range, 89.0-81.0; median Snellen equivalent, 20/20 [20/16-20/25]).","[{'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Carl W', 'Initials': 'CW', 'LastName': 'Baker', 'Affiliation': 'Paducah Retinal Center, Paducah, Kentucky.'}, {'ForeName': 'Wesley T', 'Initials': 'WT', 'LastName': 'Beaulieu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Omar S', 'Initials': 'OS', 'LastName': 'Punjabi', 'Affiliation': 'Charlotte Eye, Ear, Nose, and Throat Associates PA, Charlotte, North Carolina.'}, {'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Stockdale', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Blanton Eye Institute, Houston, Texas.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Joslin Diabetes Center, Beetham Eye Institute, Harvard Department of Ophthalmology, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.6035']
260,31376386,"Impact of intervention on nutritional status, consumption of processed foods, and quality of life of adolescents with excess weight.","OBJECTIVE
To evaluate the impact of a nutritional intervention on nutritional status, ultra-processed food consumption, and quality of life of adolescents with excess weight.
METHODS
Experimental study with adolescent students with excess weight, divided into two groups, an intervention group and a control group. The nutritional intervention lasted six months, with an educational and motivational approach. Nutritional status (waist circumference and body mass index), quality of life, and ultra-processed food consumption were evaluated before and after the period.
RESULTS
Sixty-two adolescents with overweight or obesity participated in the study, 37 in the intervention group and 25 in the control group, aged 13.2±1.5 years in intervention group, and 13.0±1.8 years in control group, both of which had a higher female participation. There were changes in the body mass index (intervention group Δ: -0.81±2.28, control group Δ: -0.64±1.28) and in the waist circumference for intervention group (Δ:-3.31±5.47). For the pre- and post-ultra-processed food consumption, there was a significant reduction in the consumption of soft drinks in the intervention group (Δ: -0.07 [-0.27 to 0.00]), instant noodles (Δ: -0.03 [-0.07 to 0.00]), and sandwich cookies (Δ: -0.06 [-0.26 to 0.00]). The quality of life increased in the intervention group and decreased in the control group, with no intra- (p=0.162) or intergroup statistical relevance in the pre- (p=0.426) and post- (0.249) intervention period, with a reduction in the emotional domain score, with a significant variation in the intervention group (pre and post; Δ: -19.0±40.6).
CONCLUSION
There was a decrease in body mass index and waist circumference (central obesity being more often related to insulin resistance), reduction of ultra-processed food consumption (soft drinks, sandwich cookies, and instant noodles), and a tendency toward quality of life improvement (however, there was a decrease in the domains of emotional and school quality of life).",2020,"The quality of life increased in the intervention group and decreased in the control group, with no intra-","['Sixty-two adolescents with overweight or obesity participated in the study, 37 in the intervention group and 25 in the control group, aged 13.2±1.5 years in intervention group, and 13.0±1.8 years in control group, both of which had a higher female participation', 'Experimental study with adolescent students with excess weight', 'adolescents with excess weight']",['nutritional intervention'],"['Nutritional status (waist circumference and body mass index), quality of life, and ultra-processed food consumption', 'nutritional status, consumption of processed foods, and quality of life', 'body mass index and waist circumference (central obesity', 'consumption of soft drinks', 'quality of life', 'body mass index', 'nutritional status, ultra-processed food consumption, and quality of life', 'domains of emotional and school quality of life']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",[],"[{'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0034380'}, {'cui': 'C0344355', 'cui_str': 'Convenience Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4551560', 'cui_str': 'Central obesity (disorder)'}, {'cui': 'C3489624', 'cui_str': 'Soft Drinks'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]",62.0,0.020214,"The quality of life increased in the intervention group and decreased in the control group, with no intra-","[{'ForeName': 'Fabiana A', 'Initials': 'FA', 'LastName': 'Poll', 'Affiliation': 'Universidade de Santa Cruz do Sul (UNISC), Departamento de Educação Física e Saúde, Santa Cruz do Sul, RS, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Miraglia', 'Affiliation': 'Universidade La Salle (UNILASALLE), Programa de Pós-Graduação em Saúde e Desenvolvimento Humano e Graduação em Nutrição, Canoas, RS, Brazil.'}, {'ForeName': 'Helen F', 'Initials': 'HF', 'LastName': ""D'avila"", 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Programa de Pós-Graduação da Saúde da Criança e do Adolescente, Porto Alegre, RS, Brazil. Electronic address: helen14davila@hotmail.com.'}, {'ForeName': 'Cézane P', 'Initials': 'CP', 'LastName': 'Reuter', 'Affiliation': 'Universidade de Santa Cruz do Sul (UNISC), Departamento de Educação Física e Saúde, Santa Cruz do Sul, RS, Brazil.'}, {'ForeName': 'Elza D', 'Initials': 'ED', 'LastName': 'Mello', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Programa de Pós-Graduação da Saúde da Criança e do Adolescente, Porto Alegre, RS, Brazil.'}]",Jornal de pediatria,['10.1016/j.jped.2019.05.007']
261,32199339,Multisession transcranial direct current stimulation facilitates verbal learning and memory consolidation in young and older adults.,"This study investigated effects of multisession transcranial direct-current stimulation on learning and maintenance of novel memory content and scrutinised effects of baseline cognitive status and the role of multi-session tDCS on overnight memory consolidation. In a prospective, randomized, double-blind, parallel-group, sham-tDCS controlled design, 101 healthy young and older adults completed a five-day verbal associative learning paradigm while receiving multisession tDCS to the task-relevant left prefrontal cortex. In older adults, active multisession tDCS enhanced recall performance after each daily training session. Effects were maintained the next morning and during follow-up assessments (one week; three months). In young adults, multisession tDCS significantly increased long-term recall. Unlike previous findings in the motor domain, beneficial effects of multisession tDCS on cognitive learning and memory were notexclusively due to enhanced memory consolidation. Positive stimulation effects were primarily found in participants with lower baseline learning ability, suggesting that multisession tDCS may counteract memory impairment in health and disease.",2020,"Unlike previous findings in the motor domain, beneficial effects of multisession tDCS on cognitive learning and memory were notexclusively due to enhanced memory consolidation.","['101 healthy young and older adults completed a', 'young and older adults']","['multisession transcranial direct-current stimulation', 'five-day verbal associative learning paradigm while receiving multisession tDCS', 'sham-tDCS', 'multisession tDCS', 'Multisession transcranial direct current stimulation facilitates verbal learning and memory consolidation']","['multisession tDCS significantly increased long-term recall', 'recall performance', 'Positive stimulation effects', 'overnight memory consolidation']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0679057', 'cui_str': 'Memory Consolidation'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0679057', 'cui_str': 'Memory Consolidation'}]",101.0,0.0586072,"Unlike previous findings in the motor domain, beneficial effects of multisession tDCS on cognitive learning and memory were notexclusively due to enhanced memory consolidation.","[{'ForeName': 'Garon', 'Initials': 'G', 'LastName': 'Perceval', 'Affiliation': 'The University of Queensland, Centre for Clinical Research, Brisbane, Australia; Department of Psychology, School of Education, Soochow University, Suzhou, China.'}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Martin', 'Affiliation': 'The University of Queensland, Centre for Clinical Research, Brisbane, Australia; University of Kent, Department of Psychology, Canterbury, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Copland', 'Affiliation': 'The University of Queensland, Centre for Clinical Research, Brisbane, Australia; The University of Queensland, School of Health and Rehabilitation Sciences, Brisbane, Australia.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Åbo Akademi University, Department of Psychology, Turku, Finland.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Meinzer', 'Affiliation': 'The University of Queensland, Centre for Clinical Research, Brisbane, Australia; University Medicine Greifswald, Department of Neurology, Greifswald, Germany. Electronic address: marcus.meinzer@med.uni-greifswald.de.'}]",Brain and language,['10.1016/j.bandl.2020.104788']
262,32275482,Effect of storage temperature and duration on concentrations of 27 fungal secondary metabolites spiked into floor dust from an office building.,"Fungi are ubiquitous in environments and produce secondary metabolites that are usually low-molecular-weight organic compounds during growth processes. Dust samples containing these fungal secondary metabolites collected from study sites are often stored in certain temperature conditions for an extended period until laboratory analysis resources are available. However, there is little information on how stable fungal secondary metabolites are over time at different storage temperatures. We examined the stability of 27 fungal secondary metabolites spiked into floor dust samples collected from a moisture-damaged office building. Ninety-five dust aliquots were made from the spiked dust; five replicates were randomly assigned to a baseline (time = 0) and each of the 18 combinations of three temperatures (room temperature, 4 °C, or -80 °C) and six time points (2, 12, 25, 56, 79, and 105 weeks). At the baseline and each subsequent time point, we extracted and analyzed the fungal secondary metabolites from the spiked dust using ultra-performance liquid chromatograph-tandem mass spectrometer. To estimate change in concentration over storage time at each temperature condition, we applied multiple linear regression models with interaction effect between storage temperature and duration. For 10 of the 27 fungal secondary metabolites, the effect of time was significantly (p-values <0.05) or marginally (p-values <0.1) modified by temperature, but not for the remaining 17 metabolites. Generally, for most fungal secondary metabolites, storage at room temperature was significantly (p-values <0.05) associated with a larger decline in concentration (up to 83% for 3-nitropropionic acid at about 11 months) than storing at 4 °C (up to 55% for emodin) or -80 °C (55% for asperglaucide). We did not observe significant differences between storage at 4 °C, or -80 °C. Storage temperature influenced degradation of fungal secondary metabolites more than storage time. Our study indicates that fungal secondary metabolites, including mycotoxins in floor dust, quickly degrade at room temperature. However, storing dust samples at 4 °C might be adequate given that storing them at -80 °C did not further reduce degradation of fungal secondary metabolites.",2020,"Generally, for most fungal secondary metabolites, storage at room temperature was significantly (p-values <0.05) associated with a larger decline in concentration (up to 83% for 3-nitropropionic acid at about 11 months) than storing at 4 °C (up to 55% for emodin) or -80 °C (55% for asperglaucide).","['27 fungal secondary metabolites spiked into floor dust samples collected from a moisture-damaged office building', '27 fungal secondary metabolites spiked into floor dust from an office building', 'Ninety-five dust aliquots were made from the spiked dust; five replicates']",[],['degradation of fungal secondary metabolites'],"[{'cui': 'C0521033', 'cui_str': 'fungi'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0013330', 'cui_str': 'Dust'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0442605', 'cui_str': 'Office building'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",[],"[{'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0521033', 'cui_str': 'fungi'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0619027,"Generally, for most fungal secondary metabolites, storage at room temperature was significantly (p-values <0.05) associated with a larger decline in concentration (up to 83% for 3-nitropropionic acid at about 11 months) than storing at 4 °C (up to 55% for emodin) or -80 °C (55% for asperglaucide).","[{'ForeName': 'Mukhtar', 'Initials': 'M', 'LastName': 'Jaderson', 'Affiliation': 'Respiratory Health Division, National Institute for Occupational Safety and Health, Morgantown, West Virginia.'}, {'ForeName': 'Ju-Hyeong', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Respiratory Health Division, National Institute for Occupational Safety and Health, Morgantown, West Virginia.'}]",Journal of occupational and environmental hygiene,['10.1080/15459624.2020.1734205']
263,32248838,Effectiveness of biological nurturing on early breastfeeding problems: a randomized controlled trial.,"BACKGROUND
Biological nurturing is a neurobehavioral approach to breastfeeding support that encourages women to breastfed in a relaxed, laidback position. This approach has the potential to reduce breast problems (e.g., sore nipples), making good latch easier and thus facilitating the initiation of exclusive breastfeeding. However, its effects have not been adequately investigated in a real-life situation. The aim of this randomized controlled trial was to assess the effectiveness of biological nurturing, compared to usual hospital practices, on the frequency of breast problems and on the prevalence of exclusive breastfeeding at discharge from the maternity ward, after 1 week, and at one and 4 months.
METHODS
Open randomized parallel controlled trial carried out in a third level maternity ward (IRCCS Burlo Garofolo, Trieste, Italy) between March and December 2018. Two-hundred eight women who planned to give birth at the hospital and who expressed the intention to breastfeed were enrolled during pregnancy and randomized to receive breastfeeding support following either the biological nurturing approach or the usual care protocol based on the WHO/UNICEF 20-h course, in use at the hospital. The primary study outcome was the incidence of breast problems during hospital stay, defined as the presence of one or more of the following outcomes, collected separately: sore nipples, cracked nipples, engorgement and mastitis. The primary analysis was performed by intention to treat. The follow up lasted 4 months.
RESULTS
One hundred eighty eight out of 208 women (90.3%) were included in the analysis, 90 allocated to the biological nurturing group and 98 to the usual care group. At discharge from the maternity ward, biological nurturing significantly reduced the risk of breast problems (Relative risk [RR] 0.56, 95% Confidence Interval [CI] 0.40, 0.79), including cracked (RR 0.42, 95% CI 0.24, 0.74) and sore nipples (RR 0.59, 95% CI 0.40, 0.88). No statistically significant difference was observed for exclusive breastfeeding at discharge and up to 4 months. No adverse events occurred.
CONCLUSIONS
The biological nurturing approach applied in the real-life situation of a third level hospital was effective in preventing breast problems.
TRIAL REGISTRATION
Clinicaltrials.gov NCT03503500. Date of First Submission: 28 March 2018.",2020,"The biological nurturing approach applied in the real-life situation of a third level hospital was effective in preventing breast problems.
","['early breastfeeding problems', 'One hundred eighty eight out of 208 women (90.3%) were included in the analysis, 90 allocated to the biological nurturing group and 98 to the usual care group', 'Two-hundred eight women who planned to give birth at the hospital and who expressed the intention to breastfeed were enrolled during pregnancy and randomized to receive', 'a third level maternity ward (IRCCS Burlo Garofolo, Trieste, Italy) between March and December 2018']","['biological nurturing', 'breastfeeding support following either the biological nurturing approach or the usual care protocol based on the WHO/UNICEF 20-h course']","['risk of breast problems', 'adverse events', 'sore nipples', 'incidence of breast problems during hospital stay, defined as the presence of one or more of the following outcomes, collected separately: sore nipples, cracked nipples, engorgement and mastitis']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C1171181', 'cui_str': 'Breastfeeding support'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0250336', 'cui_str': 'CARE protocol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041682', 'cui_str': ""United Nations Children's Fund""}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0567499', 'cui_str': 'Breast problem'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0423637', 'cui_str': 'Sore nipple'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0152453', 'cui_str': 'Fissure of nipple'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0024894', 'cui_str': 'Mastitis'}]",208.0,0.136205,"The biological nurturing approach applied in the real-life situation of a third level hospital was effective in preventing breast problems.
","[{'ForeName': 'Mariarosa', 'Initials': 'M', 'LastName': 'Milinco', 'Affiliation': 'Clinical Epidemiology and Public Health Research Unit, Institute for Maternal and Child Health - IRCCS ""Burlo Garofolo"", Trieste, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Travan', 'Affiliation': 'Neonatal Intensive Care Unit, Institute for Maternal and Child Health - IRCCS ""Burlo Garofolo"", Trieste, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Cattaneo', 'Affiliation': 'Clinical Epidemiology and Public Health Research Unit, Institute for Maternal and Child Health - IRCCS ""Burlo Garofolo"", Trieste, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Knowles', 'Affiliation': 'Clinical Epidemiology and Public Health Research Unit, Institute for Maternal and Child Health - IRCCS ""Burlo Garofolo"", Trieste, Italy.'}, {'ForeName': 'Maria Vittoria', 'Initials': 'MV', 'LastName': 'Sola', 'Affiliation': 'Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), Trieste, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Causin', 'Affiliation': 'Neonatal Intensive Care Unit, Institute for Maternal and Child Health - IRCCS ""Burlo Garofolo"", Trieste, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Cortivo', 'Affiliation': 'Obstetrics and Gynecology Department, Institute for Maternal and Child Health - IRCCS ""Burlo Garofolo"", Trieste, Italy.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Degrassi', 'Affiliation': 'Obstetrics and Gynecology Department, Institute for Maternal and Child Health - IRCCS ""Burlo Garofolo"", Trieste, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Di Tommaso', 'Affiliation': 'Obstetrics and Gynecology Department, Institute for Maternal and Child Health - IRCCS ""Burlo Garofolo"", Trieste, Italy.'}, {'ForeName': 'Giuseppa', 'Initials': 'G', 'LastName': 'Verardi', 'Affiliation': 'Obstetrics and Gynecology Department, Institute for Maternal and Child Health - IRCCS ""Burlo Garofolo"", Trieste, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dipietro', 'Affiliation': 'Obstetrics and Gynecology Department, Institute for Maternal and Child Health - IRCCS ""Burlo Garofolo"", Trieste, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Piazza', 'Affiliation': 'Obstetrics and Gynecology Department, Institute for Maternal and Child Health - IRCCS ""Burlo Garofolo"", Trieste, Italy.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Scolz', 'Affiliation': 'Neonatal Intensive Care Unit, Institute for Maternal and Child Health - IRCCS ""Burlo Garofolo"", Trieste, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Rossetto', 'Affiliation': 'Life and Health Sciences Department, University of Trieste, Trieste, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Ronfani', 'Affiliation': 'Clinical Epidemiology and Public Health Research Unit, Institute for Maternal and Child Health - IRCCS ""Burlo Garofolo"", Trieste, Italy. luca.ronfani@burlo.trieste.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International breastfeeding journal,['10.1186/s13006-020-00261-4']
264,32281269,Comparison of Physical Therapy and Physician Pathways for Employees with Recent Onset Musculoskeletal Pain: A Randomized Controlled Trial.,"BACKGROUND
Life expectancy of the U.S. population will continue to rise, increasing the workforce demands in the treatment of musculoskeletal pathologies. With a declining primary care physician workforce, physical therapists (PT) may be in a unique situation to help absorb this demand.
OBJECTIVE
Our primary objective was to compare physical function between two primary care groups, a ""physical therapy-led pathway"" versus ""physician-led pathway"" in the management of recent-onset musculoskeletal pain at 1-month follow-up. Our secondary objectives were to compare other patient-important outcomes between the groups at 1 month and health utilization at 1 month and 1 year.
METHODS
A pragmatic randomized controlled trial with a 1-year follow-up was conducted, enrolling 150 university employees with recent onset musculoskeletal pain. Participants were randomized at first contact to either a PT-led pathway or physician-led pathway. The primary outcome was change in Patient-Reported Outcomes Measurement Information System (PROMIS) ShortForm v1-Physical Function 10a at 1 month; groups were compared with repeated measurement of analysis of variance and chi-square for both primary and secondary outcomes, except for satisfaction score at 1 month, which was cross-sectionally compared by independent two-sample t-test. At 1 year, healthcare utilization was assessed through medical record extraction, and healthcare utilization was converted to total episodic standard cost. Utilization was compared between groups using chi-square and Wilcoxon rank-sum tests.
RESULTS
Both groups demonstrated improvement at 1-month follow-up but showed no significant between-group difference in mean PROMIS scores at 1 month (PT-led pathway vs physician-led pathway, 2.04, [95% CI -0.28 to 4.36]; P = .082). At 1 year, there was no difference in healthcare utilization or cost between groups. No harm or misdiagnosis was found, filed, or reported by participants at 1 year.
CONCLUSION
This study shows equivalence in outcomes for two low-cost musculoskeletal care pathways with no risk of harm. These results reinforce other findings in the literature that support PTs as safe and effective initial providers for individuals with musculoskeletal disorders.",2020,"Both groups demonstrated improvement at 1-mo follow-up but showed no significant between-group difference in mean PROMIS scores at 1-mo (PT-led pathway vs physician-led pathway, 2.04, [95CI -0.28 to 4.36]; P = .0819).","['150 university employees with recent onset musculoskeletal pain', 'individuals with musculoskeletal disorders', 'For Employees With Recent Onset Musculoskeletal Pain']","['PT-led pathway or physician-led pathway', 'Physical Therapy And Physician Pathways', 'physical therapy-led pathway"" vs ""physician-led pathway']","['satisfaction score', 'No harm or misdiagnosis', 'change in PROMIS ShortForm v1-Physical Function', 'healthcare utilization or cost', 'mean PROMIS scores']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0679838', 'cui_str': 'Misdiagnosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",150.0,0.0950043,"Both groups demonstrated improvement at 1-mo follow-up but showed no significant between-group difference in mean PROMIS scores at 1-mo (PT-led pathway vs physician-led pathway, 2.04, [95CI -0.28 to 4.36]; P = .0819).","[{'ForeName': 'Heidi A', 'Initials': 'HA', 'LastName': 'Ojha', 'Affiliation': 'Physical Therapy Program, College of Public Health, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Fritz', 'Affiliation': 'College of Health, The University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Alyson L', 'Initials': 'AL', 'LastName': 'Malitsky', 'Affiliation': 'Good Shepherd Penn Partners, Bala Cynwyd, PA, USA.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Epidemiology and Biostatistics, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Weiner', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medicine, NY, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Brandi', 'Affiliation': 'Moss Rehabilitation Hospital, Physical Therapy, Philadelphia, PA, USA.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Rhon', 'Affiliation': 'Doctoral Program in Physical Therapy, JBSA Fort Sam Houston, Baylor University, San Antonio, TX, USA.'}, {'ForeName': 'Ben H P', 'Initials': 'BHP', 'LastName': 'Mobo', 'Affiliation': 'Temple University, Temple Employee Health Service, Philadelphia, PA, USA.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Fleming', 'Affiliation': 'Odyssey Physical Therapy, Philadelphia, PA, USA.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Beidleman', 'Affiliation': 'Lehigh Valley Health Network, Allentown, PA, USA.'}, {'ForeName': 'W Geoffrey', 'Initials': 'WG', 'LastName': 'Wright', 'Affiliation': 'Physical Therapy Program, College of Public Health, Temple University, Philadelphia, PA, USA.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12382']
265,32163743,Effects of theta burst stimulation over the dorsolateral prefrontal cortex on language switching - A behavioral and ERP study.,"This study investigated the role of the left dorsolateral prefrontal cortex (DLPFC) in language switching using theta burst stimulation (TBS) and electroencephalography in late bilinguals. After a sham-controlled baseline, participants received either excitatory or inhibitory TBS over the left DLPFC before conducting picture naming tasks in pure language blocks and a language switching block, as well as a nonverbal switching task. On the behavioral level, we found no effect of TBS. However, the ERP-analysis revealed an effect of Stimulation for the picture naming tasks, characterized by alterations in the left DLPFC at 20-72 ms, and in networks associated with conflict resolution and self-monitoring at 533-600 ms. As we did not find an interaction between Stimulation and Block (switching vs non-switching), prefrontal stimulation did not specifically modulate interlanguage control. The left DLPFC might rather be involved in enhancingmaintenance of task demands and self-monitoring during language production in both mono- and bilingual contexts.",2020,"However, the ERP-analysis revealed an effect of Stimulation for the picture naming tasks, characterized by alterations in the left DLPFC at 20-72 ms, and in networks associated with conflict resolution and self-monitoring at 533-600 ms.",[],"['theta burst stimulation', 'language switching using theta burst stimulation (TBS) and electroencephalography', 'excitatory or inhibitory TBS']",[],[],"[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]",[],,0.0256129,"However, the ERP-analysis revealed an effect of Stimulation for the picture naming tasks, characterized by alterations in the left DLPFC at 20-72 ms, and in networks associated with conflict resolution and self-monitoring at 533-600 ms.","[{'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Pestalozzi', 'Affiliation': 'Neurology Unit, Medicine Section, Department of Neuroscience and Movement Science, Faculty of Science and Medicine, University of Fribourg, CH-1700 Fribourg, Switzerland. Electronic address: maria.pestalozzi@unifr.ch.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Annoni', 'Affiliation': 'Neurology Unit, Medicine Section, Department of Neuroscience and Movement Science, Faculty of Science and Medicine, University of Fribourg, CH-1700 Fribourg, Switzerland. Electronic address: jean-marie.annoni@unifr.ch.'}, {'ForeName': 'René M', 'Initials': 'RM', 'LastName': 'Müri', 'Affiliation': 'Department of Neurology, University Neurorehabilitation, University Hospital Bern, Inselspital, University of Bern, CH-3010 Bern, Switzerland. Electronic address: rene.mueri@insel.ch.'}, {'ForeName': 'Lea B', 'Initials': 'LB', 'LastName': 'Jost', 'Affiliation': 'Neurology Unit, Medicine Section, Department of Neuroscience and Movement Science, Faculty of Science and Medicine, University of Fribourg, CH-1700 Fribourg, Switzerland. Electronic address: lea.jost@unifr.ch.'}]",Brain and language,['10.1016/j.bandl.2020.104775']
266,31121471,"Transcranial direct current stimulation in the treatment of cerebellar ataxia: A two-phase, double-blind, auto-matched, pilot study.","OBJECTIVE
To assess the impact of tDCS on posture, gait and coordination of movements in subjects with cerebellar ataxia.
PATIENTS AND METHODS
This is a two-phase, double blind, auto matched, pilot study. Seven people were selected to participate in the study aged from 14 to 57. tDCS and sham-tDCS were applied at different times to all participants for 40 min over five consecutive days so that they were blind to which of the two techniques was applied at any one time. The area stimulated was the bilateral motor cortex. Subjects were evaluated before and after the interventions using the Scale for Assessment and Rating of Ataxia (SARA) and specific tests to measure posture and balance were carried out using the Wii Fit platform and CvMob software.
RESULTS
The study indicates a statistically significant improvement in respect of gait parameters and the total score of the SARA scale and Wii Fit platform after tDCS when compared with data obtained from sham-tDCS trials (p: 0,03). The adverse events relating to tDCS were all self-limiting and from mild to moderate intensity.
CONCLUSION
Despite the small sample size, tDCS showed positive results in some motor parameters and could be considered a valuable new option for the treatment of cerebellar ataxias.",2019,"The study indicates a statistically significant improvement in respect of gait parameters and the total score of the SARA scale and Wii Fit platform after tDCS when compared with data obtained from sham-tDCS trials (p: 0,03).","['Seven people were selected to participate in the study aged from 14 to 57', 'subjects with cerebellar ataxia', 'cerebellar ataxia']","['Transcranial direct current stimulation', 'tDCS and sham-tDCS', 'tDCS']","['gait parameters and the total score of the SARA scale and Wii Fit platform', 'posture, gait and coordination of movements']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0007758', 'cui_str': 'Cerebellar Incoordination'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",7.0,0.0914059,"The study indicates a statistically significant improvement in respect of gait parameters and the total score of the SARA scale and Wii Fit platform after tDCS when compared with data obtained from sham-tDCS trials (p: 0,03).","[{'ForeName': 'Thiago Lima', 'Initials': 'TL', 'LastName': 'Barretto', 'Affiliation': 'Department of Neuroscience and Mental Health, Medical School of Bahia, Federal University of Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Igor Dórea', 'Initials': 'ID', 'LastName': 'Bandeira', 'Affiliation': 'Department of Neuroscience and Mental Health, Medical School of Bahia, Federal University of Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'João Gabriel', 'Initials': 'JG', 'LastName': 'Jagersbacher', 'Affiliation': 'Department of Neuroscience and Mental Health, Medical School of Bahia, Federal University of Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Bianca Lima', 'Initials': 'BL', 'LastName': 'Barretto', 'Affiliation': 'Department of Neuroscience and Mental Health, Medical School of Bahia, Federal University of Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Ângelo Frederico Souza', 'Initials': 'ÂFS', 'LastName': 'de Oliveira E Torres', 'Affiliation': 'Institute of Physics, Federal University of Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Norberto', 'Initials': 'N', 'LastName': 'Peña', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Science, Federal University of Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'José Garcia Vivas', 'Initials': 'JGV', 'LastName': 'Miranda', 'Affiliation': 'Institute of Physics, Federal University of Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Lucena', 'Affiliation': 'Department of Neuroscience and Mental Health, Medical School of Bahia, Federal University of Bahia, Salvador, Bahia, Brazil. Electronic address: rcslucena@yahoo.com.br.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2019.05.009']
267,30718038,Pretreatment Rostral Anterior Cingulate Cortex Connectivity With Salience Network Predicts Depression Recovery: Findings From the EMBARC Randomized Clinical Trial.,"BACKGROUND
Baseline rostral anterior cingulate cortex (rACC) activity is a well-replicated nonspecific predictor of depression improvement. The rACC is a key hub of the default mode network, which prior studies indicate is hyperactive in major depressive disorder. Because default mode network downregulation is reliant on input from the salience network and frontoparietal network, an important question is whether rACC connectivity with these systems contributes to depression improvement.
METHODS
Our study evaluated this hypothesis in outpatients (N = 238; 151 female) enrolled in the Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care (EMBARC) 8-week randomized clinical trial of sertraline versus placebo for major depressive disorder. Depression severity was measured using the Hamilton Rating Scale for Depression, and electroencephalography was recorded at baseline and week 1. Exact low-resolution electromagnetic tomography was used to compute activity from the rACC, and key regions within the default mode network (posterior cingulate cortex), frontoparietal network (left dorsolateral prefrontal cortex), and salience network (right anterior insula [rAI]). Connectivity in the theta band (4.5-7 Hz) and beta band (12.5-21 Hz) was computed using lagged phase synchronization.
RESULTS
Stronger baseline theta-band rACC-rAI (salience network hub) connectivity predicted greater depression improvement across 8 weeks of treatment for both treatment arms (B = -0.57, 95% confidence interval = -1.07, -0.08, p = .03). Early increases in theta-band rACC-rAI connectivity predicted greater likelihood of achieving remission at week 8 (odds ratio = 2.90, p = .03).
CONCLUSIONS
Among patients undergoing treatment, theta-band rACC-rAI connectivity is a prognostic, albeit treatment-nonspecific, indicator of depression improvement, and early connectivity changes may predict clinically meaningful outcomes.",2019,"Connectivity in the theta band (4.5-7 Hz) and beta band (12.5-21 Hz) was computed using lagged phase synchronization.
","['outpatients', 'N\xa0= 238; 151 female) enrolled in the Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care (EMBARC) 8-week randomized clinical trial of']","['sertraline versus placebo', 'rACC-rAI']","['Depression severity', 'Hamilton Rating Scale for Depression, and electroencephalography', 'theta-band rACC-rAI connectivity predicted greater likelihood of achieving remission', 'depression improvement']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.128581,"Connectivity in the theta band (4.5-7 Hz) and beta band (12.5-21 Hz) was computed using lagged phase synchronization.
","[{'ForeName': 'Alexis E', 'Initials': 'AE', 'LastName': 'Whitton', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Webb', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Dillon', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Kayser', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Rutherford', 'Affiliation': 'Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Goer', 'Affiliation': 'Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.'}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Parsey', 'Affiliation': 'Department of Psychiatry, Stony Brook University, Stony Brook, New York.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Trombello', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Deldin', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Oquendo', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Carmody', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Bruder', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts. Electronic address: dap@mclean.harvard.edu.'}]",Biological psychiatry,['10.1016/j.biopsych.2018.12.007']
268,30583852,Neural Indicators of Anhedonia: Predictors and Mechanisms of Treatment Change in a Randomized Clinical Trial in Early Childhood Depression.,"BACKGROUND
Early childhood depression is associated with anhedonia and reduced event-related potential (ERP) responses to rewarding or pleasant stimuli. Whether these neural measures are indicators of target engagement or treatment outcome is not yet known.
METHODS
We measured ERP responses to win and loss feedback in a guessing task and to pleasant versus neutral pictures in young (4.0-6.9 years of age) depressed children before and after randomization to either 18 weeks of Parent-Child Interaction Therapy-Emotion Development (PCIT-ED) treatment or waitlist (WL) control condition.
RESULTS
Analyses included reward positivity (RewP) data from 118 children randomized to PCIT-ED treatment (n = 60) or WL control condition (n = 58) at baseline and late positive potential (LPP) data from 99 children (44 PCIT-ED treatment vs. 55 WL control condition) at baseline. Children in the PCIT-ED group showed a greater reduction in anhedonia (F 1,103 = 10.32, p = .002, partial η 2 = .09). RewP reward responses increased more (F 1,87 = 5.45, p = .02, partial η 2 = .06) for PCIT-ED and a greater change in RewP was associated with a greater reduction in major depressive disorder symptoms (r = -.24, p = .05). Baseline RewP did not predict treatment change. LPPs to positive pictures did not change across treatment, but greater baseline LPPs to positive pictures predicted a higher likelihood of remission from major depressive disorder in the PCIT-ED group (B = 0.14; SE = 0.07; odds ratio = 1.15; p = .03).
CONCLUSIONS
The ERP reward response improved in young children with depression during a treatment designed to enhance emotion development, providing evidence of target engagement of the neural systems associated with reward. Further, greater baseline LPP responses to positive pictures were associated with a greater reduction in depression, suggesting that this ERP measure can predict which children are most likely to respond to treatment.",2019,"RewP reward responses increased more (F 1,87 = 5.45, p = .02, partial η 2 = .06) for PCIT-ED and a greater change in RewP was associated with a greater reduction in major depressive disorder symptoms (r = -.24, p = .05).","['Early Childhood Depression', 'in young (4.0-6.9 years of age) depressed children before and after randomization to either 18 weeks of']","['Parent-Child Interaction Therapy-Emotion Development (PCIT-ED) treatment or waitlist (WL) control condition', 'guessing task and to pleasant versus neutral pictures']","['RewP reward responses', 'ERP responses', 'major depressive disorder symptoms', 'anhedonia', 'ERP reward response']","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0337380', 'cui_str': 'Endoscopic retrograde pancreatography (procedure)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}]",118.0,0.226379,"RewP reward responses increased more (F 1,87 = 5.45, p = .02, partial η 2 = .06) for PCIT-ED and a greater change in RewP was associated with a greater reduction in major depressive disorder symptoms (r = -.24, p = .05).","[{'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Barch', 'Affiliation': 'Department of Psychological & Brain Sciences, Washington University in St. Louis, St. Louis, Missouri; Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri; Department of Radiology, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Whalen', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Gilbert', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Kelly', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Kappenman', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, California.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Hajcak', 'Affiliation': 'Department of Biomedical Science and Psychology, Florida State University, Tallahassee, Florida.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Luby', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri.'}]",Biological psychiatry,['10.1016/j.biopsych.2018.11.021']
269,30803743,"Kirschner Wires Versus Titanium Plates and Screws in Management of Unstable Phalangeal Fractures: A Randomized, Controlled Clinical Trial.","PURPOSE
To compare clinical, radiological and functional outcomes of percutaneous K-wires and lateral titanium plates and screws in the management of unstable extra-articular proximal and middle phalangeal fractures.
METHODS
In a randomized controlled clinical trial, 40 patients with unstable transverse, long oblique or spiral diaphyseal fractures of the proximal and middle phalanges were divided into 2 groups: the K-wire group (20 patients), which included 12 proximal and 8 middle phalangeal fractures fixed by percutaneous K-wires; and the plate group (20 patients), which included 13 proximal and 7 middle phalangeal fractures treated with open reduction and internal fixation with a lateral titanium plate and screws. The patients were observed for at least 6 months (mean [range], 6.9 [6-8] months). Results were evaluated by total active motion (TAM), grip strength, fracture union, pain assessed by visual analog scale and the Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire, and complications.
RESULTS
Clinical and radiological union was achieved in all patients except one in the K-wire group. Mean TAM was significantly better in the plate group than in the K-wire group. Both groups were similar in terms of postoperative loss of grip strength compared with the opposite healthy hand, and as assessed by visual analog scale and the Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire. Fewer complications occurred in the plate group (2 of 20 patients) compared with the K-wire group (5 of 20 patients).
CONCLUSIONS
Fixation of unstable proximal and middle phalangeal fractures using a titanium plate and screws through a midlateral approach is a reliable and safe method for most fracture types and is associated with higher TAM and fewer complications.
TYPE OF STUDY/LEVEL OF EVIDENCE
Therapeutic II.",2019,Mean TAM was significantly better in the plate group than in the K-wire group.,"['Unstable Phalangeal Fractures', '40 patients with unstable transverse, long oblique or spiral diaphyseal fractures of the proximal and middle phalanges', 'unstable extra-articular proximal and middle phalangeal fractures']","['percutaneous K-wires and lateral titanium plates and screws', 'Kirschner Wires Versus Titanium Plates and Screws', 'K-wire group (20 patients), which included 12 proximal and 8 middle phalangeal fractures fixed by percutaneous K-wires; and the plate group (20 patients), which included 13 proximal and 7 middle phalangeal fractures treated with open reduction and internal fixation with a lateral titanium plate and screws']","['total active motion (TAM), grip strength, fracture union, pain assessed by visual analog scale and the Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire, and complications', 'radiological union', 'Mean TAM', 'postoperative loss of grip strength', 'visual analog scale and the Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire', 'complications']","[{'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205315', 'cui_str': 'Oblique (qualifier value)'}, {'cui': 'C0522554', 'cui_str': 'Spiral'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0222682', 'cui_str': 'Phalanx structure'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular (qualifier value)'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0086510', 'cui_str': 'Kirschner Wires'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231481', 'cui_str': 'Active movement (observable entity)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",40.0,0.0286337,Mean TAM was significantly better in the plate group than in the K-wire group.,"[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El-Saeed', 'Affiliation': 'Department of Orthopedic Surgery, Port Said Hospital for Health Insurance, Port Said.'}, {'ForeName': 'Asser', 'Initials': 'A', 'LastName': 'Sallam', 'Affiliation': 'Department of Orthopedic Surgery and Trauma, Suez Canal University Hospitals, Ismailia, Egypt. Electronic address: assersallam@gmail.com.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Radwan', 'Affiliation': 'Department of Orthopedic Surgery and Trauma, Suez Canal University Hospitals, Ismailia, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Metwally', 'Affiliation': 'Department of Orthopedic Surgery and Trauma, Suez Canal University Hospitals, Ismailia, Egypt.'}]",The Journal of hand surgery,['10.1016/j.jhsa.2019.01.015']
270,30627973,Phytomedicines in the Treatment of Migraine.,"Migraine is a disabling neurovascular disorder with few targeted, tolerable and effective treatments. Phytomedicines, or plant-based medicinal formulations, hold great promise in the identification of novel therapeutic targets in migraine. Many patients also turn toward herbal and plant-based therapies for the treatment of their migraines as clinical and preclinical evidence of efficacy increases. Patients seek effective and tolerable treatments instead of or in addition to current conventional pharmacologic therapies. We review some phytomedicines potentially useful for migraine treatment-feverfew (Tanacetum parthenium), butterbur (Petasites hybridus), marijuana (Cannabis spp.), Saint John's Wort (Hypericum perforatum) and the Damask rose (Rosa × damascena)-with respect to their mechanisms of action and evidence for treatment of migraine. The evidence for feverfew is mixed; butterbur is effective with potential risks of hepatotoxicity related to preparation; marijuana has not been shown to be effective in migraine treatment, and data are scant; Saint John's Wort shows relevant physiological activity but is a hepatic enzyme inducer and lacks clinical studies for this purpose; the Damask rose when used in topical preparations did not show efficacy in one clinical trial. Other plant preparations have been considered for migraine treatment but most without blinded randomized, placebo-controlled trial evidence.",2019,"Phytomedicines, or plant-based medicinal formulations, hold great promise in the identification of novel therapeutic targets in migraine.",[],"['Migraine', 'placebo']",[],[],"[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.067028,"Phytomedicines, or plant-based medicinal formulations, hold great promise in the identification of novel therapeutic targets in migraine.","[{'ForeName': 'Thilinie', 'Initials': 'T', 'LastName': 'Rajapakse', 'Affiliation': 'Division of Neurology, Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada. Thilinie.Rajapakse@albertahealthservices.ca.'}, {'ForeName': 'William Jeptha', 'Initials': 'WJ', 'LastName': 'Davenport', 'Affiliation': 'Department of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}]",CNS drugs,['10.1007/s40263-018-0597-2']
271,32279123,The immediate effect of stroboscopic visual training on information-processing time in people with multiple sclerosis: an exploratory study.,"Stroboscopic visual training (SVT) is a form of training aimed at improving visual and perceptual performance by having individuals perform activities under conditions of intermittent vision. The efficacy of SVT has never been examined in people with multiple sclerosis (PwMS), therefore, our aim was to examine the immediate effect of SVT on cognitive function, gait and static balance performance in PwMS. This assessor-blinded, randomized crossover study included 26 PwMS, 16 females, mean age 47.9 and median EDSS score 4.5. Participants attended two sessions: SVT and control training. Exercises for both the SVT and control sessions were based on ball-catching tasks. Training sessions were identical in length (40-50 min) and type of exercise drills. The difference between the two practice regimes was that the SVT session was performed wearing stroboscopic glasses and the control training was performed with similar glasses without lenses. Cognition was evaluated by a computerized software (Mindstreams ® , NeuroTrax Corp., NY). Gait and balance were evaluated via wearable accelerometers (APDM, Oregon, USA). Outcome measures were collected twice during a single session, prior to training and immediately afterward. Information processing speed (p = 0.003) increased at the post-evaluation compared with baseline, solely in the SVT session. No differences between pre-post evaluations were observed for other cognitive scores following the SVT session. No differences between pre-post measurements were noted for gait and balance following the SVT session. The present study's results justify performing future RCT studies to examine the effects of a longer SVT program on cognition in PwMS.",2020,"Information processing speed (p = 0.003) increased at the post-evaluation compared with baseline, solely in the SVT session.","['people with multiple sclerosis', '26 PwMS, 16 females, mean age 47.9 and median EDSS score 4.5', 'people with multiple sclerosis (PwMS']","['SVT and control training', 'stroboscopic visual training', 'SVT program', 'SVT', 'Stroboscopic visual training (SVT']","['Information processing speed', 'cognitive scores', 'gait and balance', 'Gait and balance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3844009', 'cui_str': '4.5'}]","[{'cui': 'C0200244', 'cui_str': 'Visual training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.0355267,"Information processing speed (p = 0.003) increased at the post-evaluation compared with baseline, solely in the SVT session.","[{'ForeName': 'Nov', 'Initials': 'N', 'LastName': 'Shalmoni', 'Affiliation': 'Department of Physical Therapy, School of Health Professions, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Kalron', 'Affiliation': 'Department of Physical Therapy, School of Health Professions, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. alonkalr@post.tau.ac.il.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-020-02190-2']
272,32279446,Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2.,"BACKGROUND & AIMS
Limited data on treatment of elderly patients with hepatocellular carcinoma (HCC) increase the unmet need. REACH and REACH-2 were global phase III studies of ramucirumab in patients with HCC after prior sorafenib, where patients with alpha-fetoprotein (AFP) ≥400 ng/mL showed an overall ssurvival (OS) benefit for ramucirumab. These post-hoc analyses examined efficacy and safety of ramucirumab in patients with HCC and baseline AFP ≥ 400 ng/mL by three prespecified age subgroups (<65, ≥65 to <75 and ≥75 years).
METHODS
Individual patient data were pooled from REACH (baseline AFP ≥400 ng/mL) and REACH-2. Kaplan-Meier and Cox proportional hazards regression methods (stratified by study) assessed OS, progression-free survival (PFS), time to progression (TTP) and patient-reported outcomes (Functional Hepatobiliary System Index-8 [FHSI-8] score).
RESULTS
A total of 542 patients (<65 years: n = 302; ≥65 to <75 years: n = 160; ≥75 years: n = 80) showed similar baseline characteristics between ramucirumab and placebo. Older subgroups had higher hepatitis C and steatohepatitis incidences, and lower AFP levels, than the <65 years subgroup. Ramucirumab prolonged OS in patients <65 years (hazard ratio [HR], 0.753; 95% CI 0.581-0.975), ≥65 to <75 years (0.602; 0.419-0.866) and ≥75 years (0.709; 0.420-1.199), PFS and TTP irrespective of age. Ramucirumab showed similar overall safety profiles across subgroups, with a consistent median relative dose intensity ≥97.8%. A trend towards a delay in symptom deterioration in FHSI-8 with ramucirumab was observed in all subgroups.
CONCLUSIONS
In this post-hoc analysis, ramucirumab showed a survival benefit across age subgroups with a tolerable safety profile, supporting its use in advanced HCC with elevated AFP, irrespective of age, including ≥75 years.",2020,"Older subgroups had higher hepatitis C and steatohepatitis incidences, and lower AFP levels, than the <65 years subgroup.","['patients with HCC and baseline AFP ≥400 ng/mL by three prespecified age subgroups (<65, ≥65 to <75, ≥75 years', 'patients with HCC after prior', 'elderly patients with hepatocellular carcinoma', 'elderly patients with hepatocellular carcinoma (HCC', '542 patients (<65 years: n = 302; ≥65 to <75 years: n = 160; ≥75 years: n = 80']","['ramucirumab', 'sorafenib', 'ramucirumab and placebo', 'Ramucirumab']","['hepatitis C and steatohepatitis incidences, and lower AFP levels', 'overall survival (OS) benefit', 'Ramucirumab prolonged OS', 'survival benefit', 'OS, progression-free survival (PFS), time to progression (TTP), and patient-reported outcomes (Functional Hepatobiliary System Index-8 [FHSI-8] score', 'overall safety profiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C2711227', 'cui_str': 'Steatohepatitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0428521', 'cui_str': 'Alpha-fetoprotein level - finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",542.0,0.134624,"Older subgroups had higher hepatitis C and steatohepatitis incidences, and lower AFP levels, than the <65 years subgroup.","[{'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Galle', 'Affiliation': 'Department of Internal Medicine, Mainz University Medical Center, Mainz, Germany.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Llovet', 'Affiliation': 'Translational Research in Hepatic Oncology Group, Liver Unit, IDIBAPS, Hospital Clinic Barcelona, University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Vogel', 'Affiliation': 'Department of Hepatology, Gastroenterology and Endocrinology, Medizinische Hochschule Hannover, Hannover, Germany.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Motomura', 'Affiliation': 'Department of Hepatology, Aso Iizuka Hospital, Fukuoka, Japan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Assenat', 'Affiliation': 'Department of Medical Oncology, CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': 'Hepatology and Gastroenterology Unit, Croix-Rousse Hospital, Northern Lyon Hospital Group, Lyon, France.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Brandi', 'Affiliation': 'Department of Experimental, Diagnostic and Speciality Medicicne, University Hospital S.Orsola-Malpighi, Bologna, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Daniele', 'Affiliation': 'Department of Oncology, Azienda Ospedaliera Gaetano Rummo, Benevento, Italy.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Jiří', 'Initials': 'J', 'LastName': 'Tomášek', 'Affiliation': 'Department of Complex Oncology Care, Masaryk Memorial Cancer Institute, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Department of Medical Oncology, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Dadduzio', 'Affiliation': 'Department of Clinical and Experimental Oncology, Medical Oncology Unit-1, Veneto Institute of Oncology (IOV) - IRCCS, Padua, Italy.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Morimoto', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Pracht', 'Affiliation': 'Department of Medical Oncology, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Min-Hua', 'Initials': 'MH', 'LastName': 'Jen', 'Affiliation': 'Global Statistical Sciences, Eli Lilly and Company, Surrey, UK.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Drove Ubreva', 'Affiliation': 'Medicines Development Unit Japan, Eli Lilly Japan K.K, Kobe, Japan.'}, {'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Widau', 'Affiliation': 'Oncology, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Medicines Development Unit Japan, Eli Lilly Japan K.K, Kobe, Japan.'}, {'ForeName': 'Reigetsu', 'Initials': 'R', 'LastName': 'Yoshikawa', 'Affiliation': 'Medicines Development Unit Japan, Eli Lilly Japan K.K, Kobe, Japan.'}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14462']
273,32279451,Effects of liraglutide and empagliflozin added to insulin therapy in patients with type 2 diabetes: A randomized controlled study.,"AIMS/INTRODUCTION
Liraglutide and empagliflozin suppress cardiovascular events. However, reports on their long-term combined use with insulin therapy or direct comparisons of these drugs are limited.
MATERIALS AND METHODS
This open-label, parallel-group, randomized controlled trial compared the effects of liraglutide and empagliflozin combined with insulin therapy in type 2 diabetes patients. Adult type 2 diabetes outpatients undergoing stable insulin therapy with glycated hemoglobin levels of 7.0-9.5% were enrolled. Participants received 0.9 mg/day liraglutide or 10 mg/day empagliflozin for 24 weeks. The primary end-point was the change in glycated hemoglobin levels from week 0 to 24. Body composition was assessed by dual-energy X-ray absorptiometry.
RESULTS
A total of 64 insulin-treated patients were randomized to receive liraglutide or empagliflozin. We analyzed 61 patients (30 liraglutide and 31 empagliflozin) who could be followed up. Liraglutide induced greater changes in glycated hemoglobin and glycated albumin than empagliflozin (glycated hemoglobin -1.24 ± 0.15% vs -0.35 ± 0.11%, P < 0.0001; glycated albumin -4.4 ± 0.6% vs -2.4 ± 0.5%, P < 0.01). Bodyweight (-1.3 ± 0.4 kg vs -1.5 ± 0.3 kg, P = 0.69) or body fat mass/lean tissue mass; urinary albumin excretion (median -5.3 mg/g-creatinine [interquartile range -60.6, 9.9 mg/g-creatinine] vs -12.9 mg/g-creatinine [interquartile range -70.8, -2.0 mg/g-creatinine], P = 0.23); and frequency of hypoglycemia did not differ significantly between the groups over a period of 24 weeks. There were no cases of study discontinuation owing to adverse effects.
CONCLUSIONS
Liraglutide addition to ongoing insulin therapy more effectively reduced glycated hemoglobin and glycated albumin levels than empagliflozin in patients with inadequately controlled type 2 diabetes.",2020,Liraglutide addition to ongoing insulin therapy effectively reduced glycated hemoglobin and glycated albumin levels than empagliflozin in patients with inadequately controlled type 2 diabetes.,"['type 2 diabetes patients', 'Sixty-four insulin-treated patients', 'Adult type 2 diabetes outpatients undergoing stable insulin therapy with glycated hemoglobin levels of 7.0-9.5% were enrolled', '61 patients (30', 'patients with inadequately controlled type 2 diabetes', 'patients with type 2 diabetes']","['empagliflozin', 'liraglutide and empagliflozin combined with insulin therapy', 'insulin therapy', 'Liraglutide and empagliflozin', 'liraglutide and empagliflozin', 'liraglutide and 31 empagliflozin', 'Liraglutide', 'liraglutide or empagliflozin', 'liraglutide or 10 mg/day empagliflozin']","['Body weight', 'change in glycated hemoglobin levels', 'glycated hemoglobin and glycated albumin', 'frequency of hypoglycemia', 'body fat mass/lean tissue mass; urinary albumin excretion [(median, IQR', 'glycated hemoglobin and glycated albumin levels', 'Body composition']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0132254', 'cui_str': 'drebrin A'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",64.0,0.0764494,Liraglutide addition to ongoing insulin therapy effectively reduced glycated hemoglobin and glycated albumin levels than empagliflozin in patients with inadequately controlled type 2 diabetes.,"[{'ForeName': 'Hirotatsu', 'Initials': 'H', 'LastName': 'Nakaguchi', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Mayu', 'Initials': 'M', 'LastName': 'Kyohara', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Konishi', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Oiwa', 'Affiliation': 'Japan Community Health Care Organization, Yokohama Chuo Hospital, Yokohama, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Terauchi', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13270']
274,32278330,The effect of two different irrigation needles on post-operative pain after pulpectomy in primary molar teeth: A randomized clinical study.,"BACKGROUND
Post-operative pain (PP) following pulpectomy is of concern for endodontic patients and dentists.
AIM
This study evaluated the intensity of PP following pulpectomy in primary maxillary molars, using two irrigation needles.
DESIGN
One hundred patients in ages ranging from 6-9 years requiring pulpectomy for asymptomatic primary teeth with non-vital pulp were included in the study. The participants were randomly assigned to two groups of 50 patients each, according to the type of irrigation needle used, that is, a conventional open-ended needle and a double side-vented needle. The teeth were obturated and then permanently restored. The presence of PP was assessed after six, 12, 24, 48, and 72 hours, and finally after one week, using a four-point pain intensity scale. The PP scores were then statistically analysed.
RESULTS
In 6, 12, and 24 hours time intervals, patients who had their teeth irrigated with the open-ended needle exhibited more intense PP than those who had their teeth irrigated with a double side-vented needle (P < .05). After 48 hours, 72 hours, and 1 week, however there was no significant difference between the groups (P > .05).
CONCLUSIONS
Side-vented needles may be preferred in order to decrease PP at the first 24 hours after pulpectomy in primary molars.",2020,"However, after 48h,72h and one week, there was no significant difference between the groups (P>0.05).
","['One hundred patients in ages ranging from 6 to 9 years requiring pulpectomy for asymptomatic primary teeth with non-vital pulp were included in the study', 'primary molar teeth', 'endodontic patients and dentists']","['conventional open-ended needle and a double side-vented needle', 'pulpectomy', 'irrigation needles']","['PP scores', 'postoperative pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034102', 'cui_str': 'Pulpectomy'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0442741', 'cui_str': 'Non-vital'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0227108', 'cui_str': 'Structure of deciduous molar tooth'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0181988', 'cui_str': 'Medication transfer needle, vented'}, {'cui': 'C0034102', 'cui_str': 'Pulpectomy'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.0418295,"However, after 48h,72h and one week, there was no significant difference between the groups (P>0.05).
","[{'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Topçuoğlu', 'Affiliation': 'Private Practice in Pedodontics, Kayseri, Turkey.'}, {'ForeName': 'Hüseyin Sinan', 'Initials': 'HS', 'LastName': 'Topçuoğlu', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Delikan', 'Affiliation': 'Department of Pedodontics Dentistry, Nuh Naci Yazgan University, Kayseri, Turkey.'}, {'ForeName': 'Seçil', 'Initials': 'S', 'LastName': 'Çalişkan', 'Affiliation': 'Department of Pedodontics Dentistry, Eskişehir Osmangazi University, Eskişehir, Turkey.'}]",International journal of paediatric dentistry,['10.1111/ipd.12652']
275,32276452,Can Post-Activation Performance Enhancement (PAPE) Improve Resistance Training Volume during the Bench Press Exercise?,"Background : The aim of the present study was to evaluate the effects of post-activation performance enhancement (PAPE) on resistance training volume during the bench press exercise (BP). The study included 12 healthy strength-trained males (age 25.2 ± 2.1 years, body mass 92.1 ± 8.7 kg, BP one-repetition maximum (1RM) 28.8 ± 10.5 kg, training experience 6.3 ± 2.1 years). Methods : The experiment was performed following a randomized crossover design, where each participant performed two different exercise protocols with a conditioning activity (CA) consisting of the BP with three sets of three repetitions at 85% 1RM (PAPE), and a control without the CA (CONT). To assess the differences between PAPE and CONT, the participants performed three sets of the BP to volitional failure at 60% 1RM. The differences in the number of performed repetitions (REP), time under tension (TUT), peak power output (PP), mean of peak power output (PP MEAN ), mean power output (MP), peak bar velocity (PV), mean of peak bar velocity (PV MEAN ), and mean bar velocity (MV) between the CONT and PAPE conditions were examined using repeated measures ANOVA. Results : The post-hoc analysis for the main condition effect indicated significant increases in TUT ( p < 0.01) for the BP following PAPE, compared to the CONT condition. Furthermore, there was a significant increase in TUT ( p < 0.01) in the third set for PAPE compared to the CONT condition. No statistically significant main effect was revealed for REP, PP, PV, PP MEAN , PV MEAN , MP, and MV. Conclusion : The main finding of the study was that the PAPE protocol increased training volume based on TUT, without changes in the number of preformed REP.",2020,"The post-hoc analysis for the main condition effect indicated significant increases in TUT ( p < 0.01) for the BP following PAPE, compared to the CONT condition.","['12 healthy strength-trained males (age 25.2 ± 2.1 years, body mass 92.1 ± 8.7 kg, BP one-repetition maximum (1RM) 28.8 ± 10.5 kg, training experience 6.3 ± 2.1 years']","[' ', 'post-activation performance enhancement (PAPE', 'control without the CA (CONT']","['REP, PP, PV, PP MEAN , PV MEAN , MP, and MV', 'TUT', 'number of performed repetitions (REP), time under tension (TUT), peak power output (PP), mean of peak power output (PP MEAN ), mean power output (MP), peak bar velocity (PV), mean of peak bar velocity (PV MEAN ), and mean bar velocity (MV']","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319697', 'cui_str': '6.3'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",12.0,0.0286939,"The post-hoc analysis for the main condition effect indicated significant increases in TUT ( p < 0.01) for the BP following PAPE, compared to the CONT condition.","[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wilk', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Filip', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Zmijewski', 'Affiliation': 'Jozef Pilsudski University of Physical Education in Warsaw, 00-809 Warsaw, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Tufano', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, 16000 Prague, Czech Republic.'}]",International journal of environmental research and public health,['10.3390/ijerph17072554']
276,32276515,Effects of Exergames on Physical Fitness in Middle-Aged and Older Adults in Taiwan.,"Using exergaming for exercise training was found to improve physical fitness. Yet, few studies have used the ""Xbox Kinect"" to examine its effects on physical fitness in healthy middle-aged and older adults. The purpose of this study was to investigate the effect of 10-weeks of Xbox Kinect training on physical fitness in healthy middle-aged and older adults. Forty participants (average 64.00 ± 4.44 years old, eight males and 32 females) were randomized to either intervention (n = 20) or control group (n = 20). The intervention group played Xbox Kinect three times per week, for an average of 50 min per session for 10 weeks. The control group was instructed to maintain their levels of physical activity. All the participants completed assessments of body composition, muscle strength, flexibility, balance and cardiopulmonary endurance at baseline and after 10-week intervention. After 10 weeks of training, the intervention group showed significant improvements in cardiopulmonary endurance and leg muscle strength. Moreover, there were significant differences between the intervention and control group in changes in aerobic fitness and leg muscle strength. The exergame program effectively improved cardiopulmonary endurance and leg muscle strength in healthy middle-aged and older adults. It could be an alternative to conventional exercise.",2020,"Moreover, there were significant differences between the intervention and control group in changes in aerobic fitness and leg muscle strength.","['Forty participants (average 64.00 ± 4.44 years old, eight males and 32 females', 'Middle-Aged and Older Adults in Taiwan', 'healthy middle-aged and older adults']","['exercise training', 'Xbox Kinect training']","['body composition, muscle strength, flexibility, balance and cardiopulmonary endurance', 'Physical Fitness', 'physical fitness', 'aerobic fitness and leg muscle strength', 'cardiopulmonary endurance and leg muscle strength']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}]",40.0,0.0142364,"Moreover, there were significant differences between the intervention and control group in changes in aerobic fitness and leg muscle strength.","[{'ForeName': 'Tzu-Cheng', 'Initials': 'TC', 'LastName': 'Yu', 'Affiliation': 'College of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Che-Hsien', 'Initials': 'CH', 'LastName': 'Chiang', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Pei-Tzu', 'Initials': 'PT', 'LastName': 'Wu', 'Affiliation': 'Department of Rehabilitation, Oregon Health and Science University Hospital, Portland, OR 97239, USA.'}, {'ForeName': 'Wen-Lan', 'Initials': 'WL', 'LastName': 'Wu', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'I-Hua', 'Initials': 'IH', 'LastName': 'Chu', 'Affiliation': 'College of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17072565']
277,32278779,"Association of Guideline-Recommended COPD Inhaler Regimens With Mortality, Respiratory Exacerbations, and Quality of Life: A Secondary Analysis of the Long-Term Oxygen Treatment Trial.","BACKGROUND
Although inhaled therapy reduces exacerbations among patients with COPD, the effectiveness of providing inhaled treatment per risk stratification models remains unclear.
RESEARCH QUESTION
Are inhaled regimens that align with the 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy associated with clinically important outcomes?
STUDY DESIGN AND METHODS
We conducted secondary analyses of Long-term Oxygen Treatment Trial (LOTT) data. The trial enrolled patients with COPD with moderate resting or exertional hypoxemia between 2009 and 2015. Our exposure was the patient-reported inhaled regimen at enrollment, categorized as either aligning with, undertreating, or potentially overtreating per the 2017 GOLD strategy. Our primary composite outcome was time to death or first hospitalization for COPD. Additional outcomes included individual components of the composite outcome and time to first exacerbation. We generated multivariable Cox proportional hazard models across strata of GOLD-predicted exacerbation risk (high vs low) to estimate between-group hazard ratios for time to event outcomes. We adjusted models a priori for potential confounders, clustered by site.
RESULTS
The trial enrolled 738 patients (73.4% men; mean age, 68.8 years). Of the patients, 571 (77.4%) were low risk for future exacerbations. Of the patients, 233 (31.6%) reported regimens aligning with GOLD recommendations; most regimens (54.1%) potentially overtreated. During a 2.3-year median follow-up, 332 patients (44.9%) experienced the composite outcome. We found no difference in time to composite outcome or death among patients reporting regimens aligning with recommendations compared with undertreated patients. Among patients at low risk, potential overtreatment was associated with higher exacerbation risk (hazard ratio, 1.42; 95% CI, 1.09-1.87), whereas inhaled corticosteroid treatment was associated with 64% higher risk of pneumonia (incidence rate ratio, 1.64; 95% CI, 1.01-2.66).
INTERPRETATION
Among patients with COPD with moderate hypoxemia, we found no difference in clinical outcomes between inhaled regimens aligning with the 2017 GOLD strategy compared with those that were undertreated. These findings suggest the need to reevaluate the effectiveness of risk stratification model-based inhaled treatment strategies.",2020,We found no difference in time-to composite outcome or death among patients reporting regimens aligning with recommendations compared to undertreated patients.,"['COPD patients with moderate hypoxemia', 'enrolled COPD patients with moderate resting or exertional hypoxemia between 2009-2015', 'and Methods', 'COPD patients', '571 patients (77.4%) were low-risk for future exacerbations', '738 patients; 73.4% were male with mean age 68.8 years']",[],"['individual components of the composite outcome and time-to first exacerbation', 'exacerbation risk', 'COPD Inhaler Regimenswith Mortality, Respiratory Exacerbations, and Quality of Life', 'risk of pneumonia', 'time-to composite outcome or death', 'time-to death or first hospitalization for COPD']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",738.0,0.234867,We found no difference in time-to composite outcome or death among patients reporting regimens aligning with recommendations compared to undertreated patients.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA. Electronic address: tlk33@uw.edu.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Spece', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Donovan', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Edmunds', 'Initials': 'E', 'LastName': 'Udris', 'Affiliation': 'Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Coggeshall', 'Affiliation': 'Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Griffith', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Bryant', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'J Allen', 'Initials': 'JA', 'LastName': 'Cooper', 'Affiliation': 'Birmingham VA Medical Center and the Lung Health Center, University of Alabama Birmingham, Birmingham, AL.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Temple University School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Philip T', 'Initials': 'PT', 'LastName': 'Diaz', 'Affiliation': '201 Heart Lung Institute, Ohio State University School of Medicine, Columbus, OH.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Fuhlbrigge', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Gay', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor, MI.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Kanner', 'Affiliation': 'University of Utah Health Sciences Center, Salt Lake City, UT.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'Panos', 'Affiliation': 'Cincinnati VA Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shade', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sternberg', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stibolt', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Stoller', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Yusen', 'Affiliation': 'Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Feemster', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}]",Chest,['10.1016/j.chest.2020.02.073']
278,32271671,Patient-Reported Cognitive Impairment Among Women With Early Breast Cancer Randomly Assigned to Endocrine Therapy Alone Versus Chemoendocrine Therapy: Results From TAILORx.,"PURPOSE
Cancer-related cognitive impairment (CRCI) is common during adjuvant chemotherapy and may persist. TAILORx provided a novel opportunity to prospectively assess patient-reported cognitive impairment among women with early breast cancer who were randomly assigned to chemoendocrine therapy (CT+E) versus endocrine therapy alone (E), allowing us to quantify the unique contribution of chemotherapy to CRCI.
METHODS
Women with a 21-gene recurrence score of 11 to 25 enrolled in TAILORX were randomly assigned to CT+E or E. Cognitive impairment was assessed among a subgroup of 552 evaluable women using the 37-item Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire, administered at baseline, 3, 6, 12, 24, and 36 months. The FACT-Cog included the 20-item Perceived Cognitive Impairment (PCI) scale, our primary end point. Clinically meaningful changes were defined a priori and linear regression was used to model PCI scores on baseline PCI, treatment, and other factors.
RESULTS
FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months compared with baseline for both groups. The magnitude of PCI change scores was greater for CT+E than E at 3 months, the prespecified primary trial end point, and at 6 months, but not at 12, 24, and 36 months. Tests of an interaction between menopausal status and treatment were nonsignificant.
CONCLUSION
Adjuvant CT+E is associated with significantly greater CRCI compared with E at 3 and 6 months. These differences abated over time, with no significant differences observed at 12 months and beyond. These findings indicate that chemotherapy produces early, but not sustained, cognitive impairment relative to E, providing reassurance to patients and clinicians in whom adjuvant chemotherapy is indicated to reduce recurrence risk.",2020,"RESULTS
FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months compared with baseline for both groups.","['Women', '552 evaluable women using the', 'women with early breast cancer', 'Women with a 21-gene recurrence score of 11 to 25 enrolled in TAILORX']","['37-item Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire', 'chemoendocrine therapy (CT+E) versus endocrine therapy alone (E', 'Endocrine Therapy', 'Chemoendocrine Therapy', 'Adjuvant CT+E', 'CT+E', 'TAILORx']","['FACT-Cog PCI scores', '20-item Perceived Cognitive Impairment (PCI) scale', 'Cognitive Impairment', 'PCI change scores', 'CRCI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",552.0,0.0961332,"RESULTS
FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months compared with baseline for both groups.","[{'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'ECOG-ACRIN Cancer Research Group Biostatistics Center, Boston, MA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Whelan', 'Affiliation': 'McMaster University, Canadian Cancer Trials Group, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sofia F', 'Initials': 'SF', 'LastName': 'Garcia', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Yanez', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}, {'ForeName': 'Amye J', 'Initials': 'AJ', 'LastName': 'Tevaarwerk', 'Affiliation': 'University of Wisconsin Madison, Carbone Cancer Center, Madison, WI.'}, {'ForeName': 'Ruth C', 'Initials': 'RC', 'LastName': 'Carlos', 'Affiliation': 'The University of Michigan Rogel Cancer Center, Ann Arbor, MI.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Maywood, IL.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Olson', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Kathleen I', 'Initials': 'KI', 'LastName': 'Pritchard', 'Affiliation': 'Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'The University of Michigan Rogel Cancer Center, Ann Arbor, MI.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'Virginia Commonwealth University Massey Cancer Center Minority/Underserved National Cancer Institute Community Oncology Research Program, Richmond, VA.'}, {'ForeName': 'E Claire', 'Initials': 'EC', 'LastName': 'Dees', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Worta J', 'Initials': 'WJ', 'LastName': 'McCaskill-Stevens', 'Affiliation': 'National Cancer Institute, Rockville, MD.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Minasian', 'Affiliation': 'National Cancer Institute, Rockville, MD.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Stanford University, Stanford, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01866']
279,31852769,"Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study.","OBJECTIVE
Faecal microbiota transplantation (FMT) from healthy donors to patients with irritable bowel syndrome (IBS) has been attempted in two previous double-blind, placebo-controlled studies. While one of those studies found improvement of the IBS symptoms, the other found no effect. The present study was conducted to clarify these contradictory findings.
DESIGN
This randomised, double-blind, placebo-controlled study randomised 165 patients with IBS to placebo (own faeces), 30 g FMT or 60 g FMT at a ratio of 1:1:1. The material for FMT was obtained from one healthy, well-characterised donor, frozen and administered via gastroscope. The primary outcome was a reduction in the IBS symptoms at 3 months after FMT (response). A response was defined as a decrease of 50 or more points in the total IBS symptom score. The secondary outcome was a reduction in the dysbiosis index (DI) and a change in the intestinal bacterial profile, analysed by 16S rRNA gene sequencing, at 1 month following FMT.
RESULTS
Responses occurred in 23.6%, 76.9% (p<0.0001) and 89.1% (p<00.0001) of the patients who received placebo, 30 g FMT and 60 g FMT, respectively. These were accompanied by significant improvements in fatigue and the quality of life in patients who received FMT. The intestinal bacterial profiles changed also significantly in the groups received FMT. The FMT adverse events were mild self-limiting gastrointestinal symptoms.
CONCLUSIONS
FMT is an effective treatment for patients with IBS. Utilising a well-defined donor with a normal DI and favourable specific microbial signature is essential for successful FMT. The response to FMT increases with the dose. Trial registration www.clinicaltrials.gov (NCT03822299) and www.cristin.no (ID657402).",2020,"RESULTS
Responses occurred in 23.6%, 76.9% (p<0.0001) and 89.1% (p<00.0001) of the patients who received placebo, 30 g FMT and 60 g FMT, respectively.","['patients with IBS', 'patients with irritable bowel syndrome', '165 patients with IBS to placebo (own faeces), 30\u2009g FMT or 60\u2009g FMT at a ratio of 1:1:1', 'healthy donors to patients with irritable bowel syndrome (IBS']","['faecal microbiota transplantation', 'FMT', 'placebo', 'Faecal microbiota transplantation (FMT', 'www.cristin.no']","['IBS symptoms', 'reduction in the dysbiosis index (DI) and a change in the intestinal bacterial profile, analysed by 16S rRNA gene sequencing', 'intestinal bacterial profiles', 'fatigue and the quality of life', 'total IBS symptom score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal Transplantation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3658208', 'cui_str': 'Disbiosis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0035899', 'cui_str': 'Ribosomal RNA Genes'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",165.0,0.430062,"RESULTS
Responses occurred in 23.6%, 76.9% (p<0.0001) and 89.1% (p<00.0001) of the patients who received placebo, 30 g FMT and 60 g FMT, respectively.","[{'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'El-Salhy', 'Affiliation': 'Stord Hospital, Stord, Norway magdy.elsalhy@sklbb.no.'}, {'ForeName': 'Jan Gunnar', 'Initials': 'JG', 'LastName': 'Hatlebakk', 'Affiliation': 'Department of Clinical Medicine, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway.'}, {'ForeName': 'Odd Helge', 'Initials': 'OH', 'LastName': 'Gilja', 'Affiliation': 'Department of Clinical Medicine, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Bråthen Kristoffersen', 'Affiliation': 'Genetic Analysis As, Oslo, Norway.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Hausken', 'Affiliation': 'Department of Clinical Medicine, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway.'}]",Gut,['10.1136/gutjnl-2019-319630']
280,32273094,1-Year Clinical Outcomes of All Comers Treated With 2 Bioresorbable Polymer-Coated Sirolimus-Eluting Stents: Propensity Score-Matched Comparison of the COMBO and Ultrathin-Strut Orsiro Stents.,"OBJECTIVES
The aim of this study was to determine 1-year safety and efficacy after treatment with the COMBO and Orsiro stents.
BACKGROUND
The COMBO stainless-steel stent has an anti-CD34 + antibody coating to capture endothelial progenitor cells, thereby promoting faster endothelialization. The Orsiro is an ultrathin-strut cobalt-chromium stent, covered by an extremely thin layer of amorphous silicon carbide to minimize ion leakage. Both devices elute sirolimus from biodegradable polymers.
METHODS
For this analysis we included European patients from the COMBO collaboration, a patient-level pooling of 2 prospective all-comers registries of COMBO stent implantation (n = 2,775), and all patients randomized to the Orsiro stent (n = 1,169) from the Dutch BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) randomized trial. The main outcome of interest was 1-year target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization evaluated using propensity score-matched analysis.
RESULTS
At baseline, COMBO patients were older and had more insulin-treated diabetes, renal insufficiency, and other comorbidities. However, Orsiro patients included more current smokers and more acute coronary syndrome presentations. Orsiro patients also received longer stents and had more complex target lesions. After propensity score-matched analysis (n = 862/arm), 1-year target lesion failure occurred in 4.1% of COMBO-treated and 2.7% of Orsiro-treated patients (hazard ratio: 1.55; 95% confidence interval: 0.92 to 2.62; p = 0.10). Definite stent thrombosis occurred in 0.5% of COMBO-treated and 0.5% of Orsiro-treated patients (p = 0.99).
CONCLUSIONS
A propensity score-matched comparison of all comers treated with the COMBO or Orsiro stent showed no statistically significant differences. Stent thrombosis risk was low and similar between the stents. (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population [BIO-RESORT], NCT01674803; MASCOT-Post Marketing Registry [MASCOT], NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the Combo Stent [REMEDEE Reg], NCT01874002).",2020,A propensity score-matched comparison of all comers treated with the COMBO or Orsiro stent showed no statistically significant differences.,"['European patients from the COMBO collaboration, a patient-level pooling of 2\xa0prospective all-comers registries of']","['2 Bioresorbable Polymer-Coated Sirolimus-Eluting Stents', 'COMBO and Orsiro stents', 'COMBO or Orsiro stent', 'COMBO stent implantation', 'Orsiro stent (n\xa0=\xa01,169) from the Dutch BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents', 'Biodegradable Polymer and Durable Polymer Drug-Eluting Stents']","['Stent thrombosis risk', '1-year target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization evaluated using propensity score-matched analysis', '1-year target lesion failure', 'complex target lesions', 'Definite stent thrombosis', '1-year safety and efficacy', 'acute coronary syndrome presentations']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]",,0.121937,A propensity score-matched comparison of all comers treated with the COMBO or Orsiro stent showed no statistically significant differences.,"[{'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Chandrasekhar', 'Affiliation': 'Icahn School of Medicine at Mount Sinai Hospital, New York, New York; Amsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Marlies M', 'Initials': 'MM', 'LastName': 'Kok', 'Affiliation': 'Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Deborah N', 'Initials': 'DN', 'LastName': 'Kalkman', 'Affiliation': 'Icahn School of Medicine at Mount Sinai Hospital, New York, New York; Amsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Melissa B', 'Initials': 'MB', 'LastName': 'Aquino', 'Affiliation': 'Icahn School of Medicine at Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zocca', 'Affiliation': 'Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Pier', 'Initials': 'P', 'LastName': 'Woudstra', 'Affiliation': 'Amsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcel A', 'Initials': 'MA', 'LastName': 'Beijk', 'Affiliation': 'Amsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Kerkmeijer', 'Affiliation': 'Amsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'Icahn School of Medicine at Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'Icahn School of Medicine at Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Karel T', 'Initials': 'KT', 'LastName': 'Koch', 'Affiliation': 'Amsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Dangas', 'Affiliation': 'Icahn School of Medicine at Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Icahn School of Medicine at Mount Sinai Hospital, New York, New York. Electronic address: roxana.mehran@mountsinai.org.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Amsterdam UMC, Heart Center, and Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.11.023']
281,31759804,Long-term Results From the FRESH RCT: Sustained Reduction of Children's Tobacco Smoke Exposure.,"INTRODUCTION
Standard care interventions to reduce children's tobacco smoke exposure (TSE) may not be sufficient to promote behavior change in underserved populations. A previous study demonstrated the short-term efficacy of an experimental counseling intervention, Family Rules for Establishing Smokefree Homes (FRESH) compared with standard care on boosting low-income children's TSE reduction and maternal smoking at 16-week end of treatment (EOT). This study tested long-term posttreatment efficacy of this treatment through a 12-month follow-up.
STUDY DESIGN
This study was a two-arm RCT.
SETTING/PARTICIPANTS
Maternal smokers (n=300) not seeking cessation treatment were recruited from low-income, urban communities. Participants exposed their <4-year-old children to tobacco smoke daily. Data collection and analyses occurred from 2006 to 2018.
INTERVENTION
The FRESH behavioral intervention included 2 home visits and 7 phone sessions. FRESH used cognitive behavioral skills training, support, problem-solving, and positive social reinforcement to facilitate the adoption of increasingly challenging TSE-protection behaviors. No nicotine-replacement therapy or medication was provided.
MAIN OUTCOME MEASURES
Primary outcomes were child cotinine (TSE biomarker) and reported TSE from EOT through 12 months after treatment. A secondary outcome was bioverified maternal smoking cessation.
RESULTS
Compared with controls, children in FRESH had significantly lower cotinine (β= -0.31, p<0.01) and lower maternal-reported TSE (β= -1.48, p=0.001) through the 12-month follow-up. A significant effect of time (β= -0.03, p=0.003) reflected a posttreatment decrease in cotinine. There was no treatment × time interaction, suggesting the treatment effect at EOT was sustained after treatment. Compared with controls, FRESH mothers maintained significantly higher odds of quitting smoking from EOT through 12-month follow-up (OR=8.87, 95% CI=2.33, 33.75).
CONCLUSIONS
Study results with a sample of underserved maternal smokers demonstrated that the short-term effect of FRESH counseling at 16-week EOT was maintained through 12 months after treatment-for both bioverified child TSE reduction and maternal smoking cessation. Smokers in low-income communities demonstrate elevated challenges to success in standard smoking treatment. FRESH follow-up results suggest the high potential value of more-intensive behavioral intervention for vulnerable smokers.
TRIAL REGISTRATION
This study is registered at www.clinicaltrials.gov NCT02117947.",2020,"Compared with controls, children in FRESH had significantly lower cotinine (β= -0.31, p<0.01) and lower maternal-reported TSE (β= -1.48, p=0.001) through the 12-month follow-up.","['Maternal smokers (n=300) not seeking cessation treatment were recruited from low-income, urban communities', ""children's tobacco smoke exposure (TSE"", ""Children's Tobacco Smoke Exposure"", 'underserved maternal smokers', 'Participants exposed their <4-year-old children to tobacco smoke daily']","['nicotine-replacement therapy', 'FRESH RCT', 'experimental counseling intervention, Family Rules for Establishing Smokefree Homes (FRESH']","['quitting smoking', 'bioverified maternal smoking cessation', 'cotinine', 'child cotinine (TSE biomarker', 'maternal smoking cessation']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke (substance)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0289046,"Compared with controls, children in FRESH had significantly lower cotinine (β= -0.31, p<0.01) and lower maternal-reported TSE (β= -1.48, p=0.001) through the 12-month follow-up.","[{'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Collins', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, Pennsylvania. Electronic address: collinsb@temple.edu.'}, {'ForeName': 'Uma S', 'Initials': 'US', 'LastName': 'Nair', 'Affiliation': 'Department of Health Promotion Sciences, College of Public Health, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Katie I', 'Initials': 'KI', 'LastName': 'DiSantis', 'Affiliation': 'Department of Public Health, Arcadia University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Melbourne F', 'Initials': 'MF', 'LastName': 'Hovell', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, School of Public Health, San Diego State University, San Diego, California.'}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Urban Public Health and Nutrition, School of Nursing and Health Sciences, La Salle University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Audrain-McGovern', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.08.021']
282,32272777,The Preventive Effect of Lactoferrin-Containing Yogurt on Gastroenteritis in Nursery School Children-Intervention Study for 15 Weeks.,"To evaluate the effects of bovine lactoferrin (LF)-containing yogurt on gastroenteritis in nursery school children during the winter season, we conducted a randomized prospective study. A total of 1296 children were randomized into a group in which LF was provided in yogurt (LF group, n = 661) and a non-LF consumption group (control group, n = 635). The LF group was given LF-containing yogurt (100 mg/day) on all 5 weekdays for approximately 15 weeks, and the control group consumed fruit jelly instead of the yogurt. The final totals of 578 children as the LF group and 584 as the control group were analyzed. The total number of children who were absent from school due to vomiting was significantly lower in the LF group compared to the control, accounting for ≥3 days in any week: 10/234 (4.3%) vs. 49/584 (8.4%), respectively; p = 0.04. Regarding the relationship between absences due to vomiting and the consumption of the LF-containing yogurt, the adjusted odds ratio for absence due to vomiting was 2.48 (95% CI: 1.19-5.14) in the LF children who consumed LF-containing yogurt ≤2 days/week compared to the LF children who consumed the yogurt ≥ 3 days/week. The consumption of LF-containing yogurt (100 mg/day) for ≥3 days/week might help alleviate the symptom of vomiting in nursery school children during the winter.",2020,"The total number of children who were absent from school due to vomiting was significantly lower in the LF group compared to the control, accounting for ≥3 days in any week: 10/234 (4.3%) vs. 49/584 (8.4%), respectively; p = 0.04.","['1296 children', '578 children as the LF group and 584 as the control group were analyzed', 'Nursery School Children-Intervention Study for 15 Weeks', 'nursery school children during the winter season', 'nursery school children during the winter']","['LF was provided in yogurt (LF group, n = 661) and a non-LF consumption group (control group, n = 635', 'bovine lactoferrin (LF)-containing yogurt', 'control group consumed fruit jelly instead of the yogurt', 'Lactoferrin-Containing Yogurt']","['symptom of vomiting', 'total number of children who were absent from school due to vomiting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036379', 'cui_str': 'Nursery school'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1440867', 'cui_str': 'Bovine lactoferrin'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",1296.0,0.0255412,"The total number of children who were absent from school due to vomiting was significantly lower in the LF group compared to the control, accounting for ≥3 days in any week: 10/234 (4.3%) vs. 49/584 (8.4%), respectively; p = 0.04.","[{'ForeName': 'Teruomi', 'Initials': 'T', 'LastName': 'Tsukahara', 'Affiliation': 'Department of Occupational Medicine, School of Medicine, Shinshu University, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan.'}, {'ForeName': 'Anri', 'Initials': 'A', 'LastName': 'Fujimori', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, Shinshu University, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Misawa', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, Shinshu University, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Oda', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa 252-8583, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Yamauchi', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa 252-8583, Japan.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Abe', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry Co., Ltd, Zama, Kanagawa 252-8583, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Nomiyama', 'Affiliation': 'Department of Occupational Medicine, School of Medicine, Shinshu University, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph17072534']
283,32272792,The Effectiveness of the Good Affordable Food Intervention for Adults with Low Socioeconomic Status and Small Incomes.,"Good Affordable Food (GAF) is a small-group nutrition education intervention for adults with low socioeconomic status and small incomes. It aims to empower participants to save money on groceries and consume healthier diets. This paper reports the short-term and longer-term effects on behavioural determinants and self-reported behavioural changes. A quasi-experimental control group design was applied with a baseline measurement, a post-test immediately after the intervention, and a follow-up measurement after six months. The study included 237 participants (intervention group: n = 131; control group: n = 106) at baseline, 197 at post-test, and 152 at follow-up. Data were collected by telephone, mostly using closed interview questions. Positive short-term and longer-term effects were found for attitude towards the costs of healthy foods, food label use, and the use of liquid butter or oil to prepare hot meals. Short-term intervention effects related to knowledge towards saving money on groceries, self-efficacy towards healthy eating, portion size awareness, and mindful eating. GAF was effective in changing some determinants and behaviours related to cost and food consumption, however, mostly in the short term. Thereby, it is an example of combining pricing and health information in nutrition education that developers of effective nutrition education for low-income groups can build on.",2020,"Positive short-term and longer-term effects were found for attitude towards the costs of healthy foods, food label use, and the use of liquid butter or oil to prepare hot meals.","['adults with low socioeconomic status and small incomes', '237 participants (intervention group: n = 131; control group: n = 106) at baseline, 197 at post-test, and 152 at follow-up', 'Adults with Low Socioeconomic Status and Small Incomes']","['Good Affordable Food Intervention', 'GAF', 'Good Affordable Food (GAF']","['groceries, self-efficacy towards healthy eating, portion size awareness, and mindful eating']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C3658326', 'cui_str': 'Portion Size'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",237.0,0.0192813,"Positive short-term and longer-term effects were found for attitude towards the costs of healthy foods, food label use, and the use of liquid butter or oil to prepare hot meals.","[{'ForeName': 'Kathelijne M H H', 'Initials': 'KMHH', 'LastName': 'Bessems', 'Affiliation': 'NUTRIM School of Nutrition and Translational research in Metabolism, Maastricht University, P.O. Box 616, 6200MD Maastricht, The Netherlands.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Linssen', 'Affiliation': 'Department of Knowledge & Innovation, Public Health Service South Limburg, P.O. Box 33, 6400 AA Heerlen, The Netherlands.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Lomme', 'Affiliation': 'Dietician Practice Lomme, Lichtenberg 27 6151BS, Munstergeleen, The Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'van Assema', 'Affiliation': 'NUTRIM School of Nutrition and Translational research in Metabolism, Maastricht University, P.O. Box 616, 6200MD Maastricht, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17072535']
284,32272030,Dry Needling Combined With Guideline-Based Physical Therapy Provides No Added Benefit in the Management of Chronic Neck Pain: A Randomized Controlled Trial.,"OBJECTIVE
To determine the added benefit of combining dry needling with a guideline-based physical therapy treatment program consisting of exercise and manual therapy on pain and disability in people with chronic neck pain.
DESIGN
Randomized controlled trial.
METHODS
Participants were randomized to receive either guideline-based physical therapy or guideline-based physical therapy plus dry needling. The primary outcomes, measured at 1 month post randomization, were average pain intensity in the previous 24 hours and previous week, measured with a numeric pain-rating scale (0-10), and disability, measured with the Neck Disability Index (0-100). The secondary outcomes were pain and disability measured at 3 and 6 months post randomization and global perceived effect, quality of sleep, pain catastrophizing, and self-efficacy measured at 1, 3, and 6 months post randomization.
RESULTS
One hundred sixteen participants were recruited. At 1 month post randomization, people who received guideline-based physical therapy plus dry needling had a small reduction in average pain intensity in the previous 24 hours (mean difference, 1.56 points; 95% confidence interval [CI]: 1.11, 2.36) and in the previous week (mean difference, 1.20 points; 95% CI: 1.02, 2.21). There was no effect of adding dry needling to guideline-based physical therapy on disability at 1 month post randomization (mean difference, -2.08 points; 95% CI: -3.01, 5.07). There was no effect for any of the secondary outcomes.
CONCLUSION
When combined with guideline-based physical therapy for neck pain, dry needling resulted in small improvements in pain only at 1 month post randomization. There was no effect on disability. J Orthop Sports Phys Ther 2020;50(8):447-454. Epub 9 Apr 2020. doi:10.2519/jospt.2020.9389 .",2020,There was no effect of adding dry needling to guideline-based physical therapy on disability at 1-month post-randomization (mean difference: -2.08 points; 95% CI -1.16 to 5.07).,"['Participants', 'people with chronic neck pain', '116 participants were recruited', 'Chronic Neck Pain']","['Guideline-Based Physical Therapy', 'guideline-based physical therapy', 'guideline-based physical therapy or guideline-based physical therapy plus dry needling', 'exercise and manual therapy', 'Combining Dry Needling', 'dry needling plus guideline-based physical therapy']","['numerical pain rating scale (0-10), and disability measured with the Neck Disability Index', 'pain and disability measured at 3 and 6 months, and global perceived effect, quality of sleep, pain catastrophizing, and self-efficacy', 'average pain intensity', 'disability', 'pain', 'pain and disability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",116.0,0.188397,There was no effect of adding dry needling to guideline-based physical therapy on disability at 1-month post-randomization (mean difference: -2.08 points; 95% CI -1.16 to 5.07).,"[{'ForeName': 'Fábio Franciscatto', 'Initials': 'FF', 'LastName': 'Stieven', 'Affiliation': ''}, {'ForeName': 'Giovanni Esteves', 'Initials': 'GE', 'LastName': 'Ferreira', 'Affiliation': ''}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Wiebusch', 'Affiliation': ''}, {'ForeName': 'Francisco Xavier', 'Initials': 'FX', 'LastName': 'de Araújo', 'Affiliation': ''}, {'ForeName': 'Luis Henrique Telles', 'Initials': 'LHT', 'LastName': 'da Rosa', 'Affiliation': ''}, {'ForeName': 'Marcelo Faria', 'Initials': 'MF', 'LastName': 'Silva', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2020.9389']
285,32122951,A digital media attention diversion improves mood and fear in patients receiving chemotherapy for recurrent gynecologic malignancies: results of a randomized trial.,"BACKGROUND
Recurrent gynecologic cancer patients experience symptoms that affect psychologic, emotional, social, and physical well-being. Chemotherapy can further exacerbate these symptoms. Poor mood, pain, and fatigue are linked and are detrimental to quality of life. Interventions targeting these symptoms may improve patient-reported outcomes and performance status.
OBJECTIVES
To determine the ability of a humorous digital media attention diversion to improve symptom domains of positive and negative mood during chemotherapy for patients with recurrent gynecologic cancers.
STUDY DESIGN
This randomized, crossover clinical trial enrolled women with recurrent gynecologic cancers. Subjects participated over three cycles of chemotherapy. The primary outcome was the change in mood on the validated Positive and Negative Affect Scale-Extended (PANAS-X) instrument, which measures positive and negative affect domains. All subjects completed the PANAS-X after receiving chemotherapy during cycle 1 on study. In atudy arm 1, subjects watched their choice of humorous movies on a digital media device while receiving chemotherapy during cycle 2 on study. They selected from non-humorous movies during cycle 3 on study. In arm 2, the order of movies was reversed. After each cycle, mood, fatigue, and other patient-reported outcomes were assessed for comparison with baseline measurements.
RESULTS
The target enrollment of 66 subjects was achieved. Subjects watched humorous content for an average of 96.0 min and non-humorous content for an average of 62.5 min. Negative mood improved after exposure to humorous (p=0.017) and non-humorous content (p=0.001). Patient-reported fear also improved after exposure to both humorous (p=0.038) and non-humorous content (p=0.002). Subjects reported higher use of affiliating and self-effacing humor types.
CONCLUSIONS
Offering patients a choice of digital media during chemotherapy significantly improved negative mood and fear. This was seen with both humorous and non-humorous content. This low-cost and low-risk intervention should be implemented as an attention diversion to improve negative mood and fear for patients receiving chemotherapy.",2020,Negative mood improved after exposure to humorous (p=0.017) and non-humorous content (p=0.001).,"['Recurrent gynecologic cancer patients experience symptoms', 'patients receiving chemotherapy', 'patients with recurrent gynecologic cancers', 'enrolled women with recurrent gynecologic cancers', 'patients receiving chemotherapy for recurrent gynecologic malignancies']","['chemotherapy', 'digital media attention diversion', 'humorous digital media attention diversion', 'Chemotherapy', 'digital media device while receiving chemotherapy']","['change in mood on the validated Positive and Negative Affect Scale-Extended (PANAS-X) instrument, which measures positive and negative affect domains', 'Negative mood', 'mood and fear', 'negative mood and fear', 'Poor mood, pain, and fatigue']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0185033', 'cui_str': 'Diversion'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.0441354,Negative mood improved after exposure to humorous (p=0.017) and non-humorous content (p=0.001).,"[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Spencer', 'Affiliation': 'Gynecologic Oncology, University of Wisconsin Madison School of Medicine and Public Health, Madison, Wisconsin, USA rjspencer2@wisc.edu.'}, {'ForeName': 'Vinita', 'Initials': 'V', 'LastName': 'Alexander', 'Affiliation': 'Obstetrics and Gynecology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Eickhoff', 'Affiliation': 'Biostatistics and Medical Informatics, University of Wisconsin Madison, Madison, Wisconsin, USA.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Woo', 'Affiliation': 'Biostatistics and Medical Informatics, University of Wisconsin Madison, Madison, Wisconsin, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Costanzo', 'Affiliation': 'Psychiatry, University of Wisconsin Madison School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Marx', 'Affiliation': 'Communications Studies, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': 'Gynecologic Oncology, University of Wisconsin Madison School of Medicine and Public Health, Madison, Wisconsin, USA.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-001185']
286,32112114,Comparison of intubating conditions after induction with propofol and remifentanil or sufentanil : Randomized controlled REMIDENT trial for surgical tooth extraction.,"PURPOSE
The aim of this study was to compare tracheal intubation conditions after induction of anesthesia with a bolus of propofol-sufentanil or propofol-remifentanil and a rapid induction technique.
MATERIAL AND METHODS
A total of 70 patients (American Society of Anesthesiologists (ASA) classification I‑II) undergoing outpatient surgery under general anesthesia with intubation for tooth extraction were randomly assigned to two groups in this double-blind study. Patients received either a bolus of remifentanil (3 μg/kg) or sufentanil (0.3 μg/kg) together with 2.5 mg/kg propofol for intubation. The primary outcome was the percentage of excellent intubation conditions and the secondary outcomes were the percentage of patients with a decrease of over 20% in mean arterial pressure (MAP) or heart rate (HR), time to achieve spontaneous respiration, time between the end of surgery and extubation and time to achieve an Aldrete score of 10. VAS pain score was >3 or having laryngeal pain 15 min after arriving in the postanesthesia care unit (PACU) were also analyzed.
RESULTS
Intubating conditions (perfect + good conditions) were significantly better with remifentanil than with sufentanil (88.5% vs. 68.6%; p = 0.01). When using remifentanil, the hemodynamic conditions were good. Using remifentanil did not significantly increase the pain score or the laryngeal pain in the recovery room. This was confirmed by no significant differences between the groups for morphine consumption. Remifentanil significantly decreased the time to achieve an Aldrete score of 10.
CONCLUSION
When intubation without muscle relaxants is required, intubating conditions are much better when a remifentanil bolus is used compared to a sufentanil bolus. The remifentanil/propofol rapid induction technique is a valuable technique to quickly intubate and achieve good conditions.",2020,"RESULTS
Intubating conditions (perfect + good conditions) were significantly better with remifentanil than with sufentanil (88.5% vs. 68.6%; p = 0.01).",['70\xa0patients (American Society of Anesthesiologists (ASA) classification I‑II) undergoing outpatient surgery under general anesthesia with intubation for tooth extraction'],"['Remifentanil', 'propofol and remifentanil', 'propofol', 'sufentanil ', 'remifentanil/propofol', 'remifentanil', 'sufentanil', 'propofol-sufentanil or propofol-remifentanil']","['mean arterial pressure (MAP) or heart rate (HR), time to achieve\xa0spontaneous respiration, time between the end of surgery and extubation and time to achieve an Aldrete score of\xa010', 'pain score or the laryngeal pain', 'VAS pain score', 'percentage of excellent intubation conditions', 'time to achieve an Aldrete score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040440', 'cui_str': 'Tooth Extraction'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration (finding)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0549373', 'cui_str': 'Laryngeal pain'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",,0.236305,"RESULTS
Intubating conditions (perfect + good conditions) were significantly better with remifentanil than with sufentanil (88.5% vs. 68.6%; p = 0.01).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dolsan', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Toulouse University Hospital, Avenue Jean Poulhès, 31432, Toulouse, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bruneteau', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Toulouse University Hospital, Avenue Jean Poulhès, 31432, Toulouse, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roche', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Toulouse University Hospital, Avenue Jean Poulhès, 31432, Toulouse, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ferré', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Toulouse University Hospital, Avenue Jean Poulhès, 31432, Toulouse, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Labaste', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Toulouse University Hospital, Avenue Jean Poulhès, 31432, Toulouse, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sommet', 'Affiliation': 'Laboratory of Medical and Clinical Pharmacology, Pharmacoepidemiology, Inserm U1027, Toulouse University, Faculty of Medicine, Toulouse, France.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Conil', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Toulouse University Hospital, Avenue Jean Poulhès, 31432, Toulouse, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Minville', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Toulouse University Hospital, Avenue Jean Poulhès, 31432, Toulouse, France. minville.v@chu-toulouse.fr.'}]",Der Anaesthesist,['10.1007/s00101-020-00739-0']
287,32166395,Unilateral transversus abdominis plane block and port-site infiltration : Comparison of postoperative analgesic efficacy in laparoscopic cholecystectomy.,"PURPOSE
To compare the analgesic efficacy of unilateral subcostal transversus abdominis plane (TAP) block with local anesthetic infiltration, applied to the port site in patients undergoing laparoscopic cholecystectomy (LC).
METHODS
Group T received a unilateral subcostal TAP block, group I received a local anesthetic infiltration at port sites, and group C was the control group. Groups T and I received 20 mL 0.25% bupivacaine. Intravenous patient-controlled analgesia with tramadol was similarly applied to all groups. Postoperative pain levels during rest and cough were evaluated using a numeric rating scale (NRS). Nausea and vomiting were evaluated using postoperative nausea vomiting scores (PONV) at 1, 3, 6, 12 and 24 h and tramadol consumption was also determined. Patient satisfaction was evaluated using a Likert-type scale.
RESULTS
Postoperative resting NRS scores were lower in group T than the other groups at 1 h and 12 h (p = 0.007 and p = 0.016), while NRS values during cough were statistically significant at 1 h (p = 0.004). The 24‑h tramadol consumption was different: group T 229 ± 33 mg, group I 335 ± 95 mg, and group C 358 ± 66 mg (p < 0.001). The percentages of patients reporting that they would prefer the applied postoperative pain control method again were 83.3%, 62.5% and 70.8% in groups T, I and C, respectively (p = 0.118).
CONCLUSION
Unilateral subcostal TAP block was superior to local anesthetic infiltration at port sites after LC, in terms of low opioid consumption. Unilateral subcostal TAP block is recommended as part of a multimodal analgesic protocol.",2020,"Postoperative resting NRS scores were lower in group T than the other groups at 1 h and 12 h (p = 0.007 and p = 0.016), while NRS values during cough were statistically significant at 1 h (p = 0.004).",['patients undergoing laparoscopic cholecystectomy (LC'],"['Unilateral transversus abdominis plane block and port-site infiltration ', '20\u202fmL 0.25% bupivacaine', 'laparoscopic cholecystectomy', 'tramadol', 'Unilateral subcostal TAP block', 'unilateral subcostal transversus abdominis plane (TAP) block with local anesthetic infiltration', 'unilateral subcostal TAP block, group\xa0I received a local anesthetic infiltration']","['analgesic efficacy', 'postoperative nausea vomiting scores (PONV', 'Postoperative resting NRS scores', 'NRS values during cough', 'numeric rating scale (NRS', 'Patient satisfaction', 'Nausea and vomiting', 'Postoperative pain levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0442184', 'cui_str': 'Subcostal (qualifier value)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0198813', 'cui_str': 'Local anesthesia, by infiltration (procedure)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0251994,"Postoperative resting NRS scores were lower in group T than the other groups at 1 h and 12 h (p = 0.007 and p = 0.016), while NRS values during cough were statistically significant at 1 h (p = 0.004).","[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Arık', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Altındağ, Ankara, Turkey. emineincearik@yahoo.com.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Akkaya', 'Affiliation': 'Department of Anesthesiology, Pain Clinic, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ozciftci', 'Affiliation': 'Department of Anesthesiology and Reanimation, TC Ministry of Health Hitit University Erol Olçok Training and Research Hospital, Çorum, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alptekin', 'Affiliation': 'Department of Anesthesiology, Pain Clinic, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ş', 'Initials': 'Ş', 'LastName': 'Balas', 'Affiliation': 'Department of Surgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}]",Der Anaesthesist,['10.1007/s00101-020-00746-1']
288,31767947,Clinical recommendations for use of lidocaine lubricant during bowel care after spinal cord injury prolong care routines and worsen autonomic dysreflexia: results from a randomised clinical trial.,"STUDY DESIGN
Clinical trial.
OBJECTIVE
Spinal cord injury (SCI) impacts autonomic function and bowel management. Bowel care is a potential trigger for autonomic dysreflexia (AD; paroxysmal hypertension elicited by sensory stimuli below the level of lesion). AD can be life threatening so strategies to minimise AD are prioritised after SCI. Lidocaine lubricant is recommended during bowel care with the rationale to minimise the sensory stimulus, reducing AD. The objective of this study was to assess whether lidocaine lubricant (Xylocaine 2%) ameliorates AD during at-home bowel care compared with standard lubricant (placebo).
SETTING
Community.
METHOD
Participants (n = 13; age 44.0 ± 3.3 years) with high-level SCI (C3-T4) performed their normal at-home bowel care on two days, each time using a different lubricant, with continuous non-invasive cardiovascular monitoring. Injury to spinal autonomic (sympathetic) nerves was determined from low-frequency systolic arterial pressure (LF SAP) variability.
RESULTS
Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg 2 ), suggesting impaired autonomic control. Bowel care duration was increased with lidocaine (79.1 ± 10.0 min) compared to placebo (57.7 ± 6.3 min; p = 0.018). All participants experienced AD on both days, but maximum SAP was higher with lidocaine (214.3 ± 10.5 mmHg) than placebo (196.7 ± 10.0 mmHg; p = 0.046). Overall, SAP was higher for longer with lidocaine (6.5 × 10 5 ± 0.9 × 10 5 mmHg • beat) than placebo (4.4 × 10 5 ± 0.6 × 10 5 mmHg • beat; p = 0.018) indicating a higher burden of AD. Heart rate and rhythm disturbances were increased during AD, particularly with lidocaine use.
CONCLUSIONS
At-home bowel care was a potent trigger for AD. Our findings contradict recommendations for lidocaine use during bowel care, suggesting that anaesthetic lubricants impair reflex bowel emptying, resulting in longer care routines with an increased burden of AD.",2020,"RESULTS
Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg 2 ), suggesting impaired autonomic control.","['Participants (n\u2009=\u200913; age 44.0\u2009±\u20093.3\xa0years) with high-level SCI (C3-T4) performed their normal at-home bowel care on two days, each time using a different lubricant, with continuous non-invasive cardiovascular monitoring', 'during bowel care after spinal cord injury prolong care routines and worsen autonomic dysreflexia', 'Community']","['lidocaine', 'standard lubricant (placebo', 'placebo', 'lidocaine lubricant', 'lidocaine lubricant (Xylocaine 2%) ameliorates AD', 'Lidocaine lubricant']","['autonomic function', 'Overall, SAP', 'maximum SAP', 'Heart rate and rhythm disturbances', 'Bowel care duration', 'low-frequency systolic arterial pressure (LF SAP) variability']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0161959', 'cui_str': 'Cardiovascular monitoring (regime/therapy)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0238015', 'cui_str': 'Spinal Autonomic Dysreflexia'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0699094', 'cui_str': 'Xylocaine'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.186011,"RESULTS
Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg 2 ), suggesting impaired autonomic control.","[{'ForeName': 'Vera-Ellen M', 'Initials': 'VM', 'LastName': 'Lucci', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Maureen S', 'Initials': 'MS', 'LastName': 'McGrath', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Inskip', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Shirromi', 'Initials': 'S', 'LastName': 'Sarveswaran', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Willms', 'Affiliation': 'International Collaboration on Repair and Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Claydon', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada. victoria_claydon@sfu.ca.'}]",Spinal cord,['10.1038/s41393-019-0381-2']
289,31700147,The effects of local cooling rates on perfusion of sacral skin under externally applied pressure in people with spinal cord injury: an exploratory study.,"STUDY DESIGN
Experimental before-after design.
OBJECTIVES
The objectives of this study were to explore the effects of local cooling rates on perfusion of sacral skin under externally applied pressure in people with spinal cord injury (SCI).
SETTING
Research laboratory.
METHODS
Seventeen participants, including seven wheelchair users with SCI and ten able-bodied (AB) controls. Each participant underwent seven protocols, including pressure (60 mmHg) with local cooling (∆t = -10 °C) for 20 min at three cooling rates (-0.5, -4, -10 °C/min), pressure with local cooling for 40 min, pressure with local heating (∆t = +10 °C), local cooling without pressure, and pressure without temperature changes. Each protocol included a 10-min baseline, a 20-min (or 40-min) loading period and a 20-min recovery. A compound sensor head consisting of laser Doppler and heating and cooling probes was used to measure sacral skin blood flow and temperature in the prone position. Blood flow responses were characterized by peak blood flow, recovery time, and total blood flow in the recovery period.
RESULTS
The results demonstrated that the cooling rate at -10 °C/min resulted in smaller skin blood flow response compared with -0.5 °C/min (p < 0.05) but were not significantly different to the cooling rate at -4 °C/min. There was a significant difference in the recovery time between the 20-min cooling compared with the 40-min cooling for the SCI group (p < 0.05).
CONCLUSIONS
Our findings provide initial evidence that local cooling rates affect skin blood flow responses under externally applied pressure in people with SCI.",2020,C/min resulted in smaller skin blood flow response compared with -0.5 °C/min (p < 0.05) but were not significantly different to the cooling rate at -4 °C/min.,"['people with spinal cord injury', 'people with spinal cord injury (SCI', 'people with SCI', 'Seventeen participants, including seven wheelchair users with SCI and ten able-bodied (AB) controls']","['laser Doppler and heating and cooling probes', 'local cooling rates']","['peak blood flow, recovery time, and total blood flow', 'cooling rate at -10', 'smaller skin blood flow response', 'cooling rate', 'sacral skin blood flow and temperature', 'recovery time', 'Blood flow responses']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0853966', 'cui_str': 'Wheelchair user'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0430489', 'cui_str': 'Laser doppler (procedure)'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",17.0,0.0858534,C/min resulted in smaller skin blood flow response compared with -0.5 °C/min (p < 0.05) but were not significantly different to the cooling rate at -4 °C/min.,"[{'ForeName': 'Yih-Kuen', 'Initials': 'YK', 'LastName': 'Jan', 'Affiliation': 'Rehabilitation Engineering Lab, Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Champaign, IL, USA. yjan@illinois.edu.'}]",Spinal cord,['10.1038/s41393-019-0378-x']
290,31710340,"Reactions to Multiple Ascending Doses of the Microtubule Stabilizer TPI-287 in Patients With Alzheimer Disease, Progressive Supranuclear Palsy, and Corticobasal Syndrome: A Randomized Clinical Trial.","Importance
Basket-design clinical trials that allow investigation of treatment effects on different clinical syndromes that share the same molecular pathophysiology have not previously been attempted in neurodegenerative disease.
Objective
To assess the safety, tolerability, and pharmacodynamics of the microtubule stabilizer TPI-287 (abeotaxane) in Alzheimer disease (AD) or the 4-repeat tauopathies (4RT) progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS).
Design, Setting, and Participants
Two parallel-design, double-blind, placebo-controlled phase 1 randomized clinical trials in AD and 4RT were conducted from December 20, 2013, through May 4, 2017, at the University of California, San Francisco, and University of Alabama at Birmingham. A total of 94 patients with clinically diagnosed AD (n = 39) and 4RT (n = 55) were screened; of these, 3 refused to participate, and 10 with AD and 11 with 4RT did not meet inclusion criteria. A total of 29 patients with AD, 14 with PSP, and 30 with β-amyloid-negative CBS (determined on positron emission tomography findings) were enrolled. Data were analyzed from December 20, 2013, through May 4, 2017, based on modified intention to treat.
Interventions
Randomization was 8:3 drug to placebo in 3 sequential dose cohorts receiving 2.0, 6.3, or 20.0 mg/m2 of intravenous TPI-287 once every 3 weeks for 9 weeks, with an optional 6-week open-label extension.
Main Outcomes and Measures
Primary end points were safety and tolerability (maximal tolerated dose) of TPI-287. Secondary and exploratory end points included TPI-287 levels in cerebrospinal fluid (CSF) and changes on biomarker, clinical, and neuropsychology measures.
Results
A total of 68 participants (38 men [56%]; median age, 65 [range, 50-85] years) were included in the modified intention-to-treat analysis, of whom 26 had AD (14 women [54%]; median age, 63 [range, 50-76] years), and 42 had 4RT (16 women [38%]; median age, 69 [range, 54-83] years). Three severe anaphylactoid reactions occurred in TPI-287-treated patients with AD, whereas none were seen in patients with 4RT, leading to a maximal tolerated dose of 6.3 mg/m2 for AD and 20.0 mg/m2 for 4RT. More falls (3 in the placebo group vs 11 in the TPI-287 group) and a dose-related worsening of dementia symptoms (mean [SD] in the CDR plus NACC FTLD-SB [Clinical Dementia Rating scale sum of boxes with frontotemporal dementia measures], 0.5 [1.8] in the placebo group vs 0.7 [1.6] in the TPI-287 group; median difference, 1.5 [95% CI, 0-2.5]; P = .03) were seen in patients with 4RT. Despite undetectable TPI-287 levels in CSF, CSF biomarkers demonstrated decreased chitinase-3-like protein-1 (YKL-40) levels in the 4RT treatment arm (mean [SD], -8.4 [26.0] ng/mL) compared with placebo (mean [SD], 10.4 [42.3] ng/mL; median difference, -14.6 [95% CI, -30.0 to 0.2] ng/mL; P = .048, Mann-Whitney test).
Conclusions and Relevance
In this randomized clinical trial, TPI-287 was less tolerated in patients with AD than in those with 4RT owing to the presence of anaphylactoid reactions. The ability to reveal different tau therapeutic effects in various tauopathy syndromes suggests that basket trials are a valuable approach to tau therapeutic early clinical development.
Trial Registration
ClinicalTrials.gov identifiers: NCT019666666 and NCT02133846.",2020,"Despite undetectable TPI-287 levels in CSF, CSF biomarkers demonstrated decreased chitinase-3-like protein-1 (YKL-40) levels in the 4RT treatment arm (mean [SD], -8.4 ","['29 patients with AD, 14 with PSP, and 30 with β-amyloid-negative CBS (determined on positron emission tomography findings) were enrolled', '94 patients with clinically diagnosed AD (n\u2009=\u200939) and 4RT (n\u2009=\u200955) were screened; of these, 3 refused to participate, and 10 with AD and 11 with 4RT did not meet inclusion criteria', '16 women [38%]; median age, 69 [range, 54-83] years', 'patients with AD than in those with 4RT owing to the presence of anaphylactoid reactions', 'Patients With Alzheimer Disease, Progressive Supranuclear Palsy, and Corticobasal Syndrome', 'Alzheimer disease (AD) or the 4-repeat tauopathies (4RT) progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS', 'controlled phase 1 randomized clinical trials in AD and 4RT were conducted from December 20, 2013, through May 4, 2017, at the University of California, San Francisco, and University of Alabama at Birmingham', '68 participants (38 men [56%]; median age, 65 [range, 50-85] years) were included in the modified intention-to-treat analysis, of whom 26 had AD (14 women [54%]; median age, 63 [range, 50-76] years), and 42 had 4RT']","['microtubule stabilizer TPI-287 (abeotaxane', 'placebo', 'Microtubule Stabilizer TPI-287', 'TPI-287']","['safety and tolerability (maximal tolerated dose) of TPI-287', 'CDR plus NACC FTLD-SB [Clinical Dementia Rating scale sum of boxes with frontotemporal dementia measures', 'severe anaphylactoid reactions', 'TPI-287 levels in cerebrospinal fluid (CSF) and changes on biomarker, clinical, and neuropsychology measures', 'worsening of dementia symptoms', 'safety, tolerability, and pharmacodynamics', 'chitinase-3-like protein-1 (YKL-40) levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0340865', 'cui_str': 'Anaphylactoid reaction (disorder)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0038868', 'cui_str': 'Steele-Richardson-Olszewski Disease'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0949664', 'cui_str': 'Tauopathies'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0026046', 'cui_str': 'Microtubules'}, {'cui': 'C1710314', 'cui_str': 'TPI-287'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C1710314', 'cui_str': 'TPI-287'}, {'cui': 'C0055351', 'cui_str': 'Chlordecone reductase'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0751072', 'cui_str': 'FTLD'}, {'cui': 'C0451074', 'cui_str': 'Dementia Rating Scale'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0338451', 'cui_str': 'Frontotemporal Lobe Dementia (FLDEM)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0340865', 'cui_str': 'Anaphylactoid reaction (disorder)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007807'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0027903', 'cui_str': 'Neuropsychologies'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C3872855', 'cui_str': 'GP-39 Protein'}]",68.0,0.508308,"Despite undetectable TPI-287 levels in CSF, CSF biomarkers demonstrated decreased chitinase-3-like protein-1 (YKL-40) levels in the 4RT treatment arm (mean [SD], -8.4 ","[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Tsai', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Miller', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Koestler', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Julio C', 'Initials': 'JC', 'LastName': 'Rojas', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ljubenkov', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Rosen', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Gil D', 'Initials': 'GD', 'LastName': 'Rabinovici', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fagan', 'Affiliation': 'Department of Neurology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Cobigo', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Brown', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Joo In', 'Initials': 'JI', 'LastName': 'Jung', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hare', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Geldmacher', 'Affiliation': ""Alzheimer's Disease Center, Department of Neurology, University of Alabama at Birmingham.""}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Natelson-Love', 'Affiliation': ""Alzheimer's Disease Center, Department of Neurology, University of Alabama at Birmingham.""}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'McKinley', 'Affiliation': ""Alzheimer's Disease Center, Department of Neurology, University of Alabama at Birmingham.""}, {'ForeName': 'Phi N', 'Initials': 'PN', 'LastName': 'Luong', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Emmeline L', 'Initials': 'EL', 'LastName': 'Chuu', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Powers', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Mumford', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Merhdad', 'Initials': 'M', 'LastName': 'Shamloo', 'Affiliation': 'Wu Tsai Neurosciences Institute, Stanford University, Palo Alto, California.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Miller', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Erik D', 'Initials': 'ED', 'LastName': 'Roberson', 'Affiliation': ""Alzheimer's Disease Center, Department of Neurology, University of Alabama at Birmingham.""}, {'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Boxer', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}]",JAMA neurology,['10.1001/jamaneurol.2019.3812']
291,32172039,Manipulating sleep duration perception changes cognitive performance - An exploratory analysis.,"OBJECTIVES
To test the effect of perceived sleep duration on cognitive performance.
METHODS
Sixteen healthy individuals [8F; mean age (± SD): 24.2 ± 3.0 years)] received an 8-h sleep opportunity followed by a 5-h opportunity on two consecutive nights. Upon waking, they were randomized to being informed that they received either an 8-h or 5-h sleep opportunity, via a clock that ran either fast, slow or normally. Cognitive performance was assessed using 10-min auditory psychomotor vigilance tests and subjective sleepiness ratings. Homeostatic and circadian sleep drive was assessed using waking electroencephalography (EEG).
RESULTS
Reaction time was significantly quicker when individuals thought that they had slept for 8 h but given a 5-h sleep opportunity. Conversely, reaction times were significantly slower when individuals thought they had 5 h of sleep but given an 8-h sleep opportunity. EEG delta power (1.0-4.5 Hz) during wake increased significantly when sleep was restricted to 5 h, and individuals thought they slept for 5 h, but this increase was attenuated with a perceived sleep duration of 8 h following a 5-h opportunity. EEG delta power did not increase, however, with perceived sleep restriction. EEG high-alpha activity (10.5-11.5 Hz) was consistently higher when participants thought that they had an 8-h sleep opportunity, regardless of the actual duration.
CONCLUSIONS
These results suggest that perceived sleep duration may modulate psychosomatic responses. Additional studies with predefined outcomes and analyses are necessary to confirm these findings, which may have important implications for understanding how sleep affects cognition and psychosomatic responses.",2020,"EEG delta power (1.0-4.5 Hz) during wake increased significantly when sleep was restricted to 5 h, and individuals thought they slept for 5 h, but this increase was attenuated with a perceived sleep duration of 8 h following a 5-h opportunity.",['Sixteen healthy individuals [8F; mean age (± SD): 24.2\xa0±\xa03.0\xa0years'],[],"['Homeostatic and circadian sleep drive', 'EEG high-alpha activity', 'reaction times', 'Cognitive performance', '10-min auditory psychomotor vigilance tests and subjective sleepiness ratings', 'EEG delta power', 'Reaction time']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",16.0,0.0585712,"EEG delta power (1.0-4.5 Hz) during wake increased significantly when sleep was restricted to 5 h, and individuals thought they slept for 5 h, but this increase was attenuated with a perceived sleep duration of 8 h following a 5-h opportunity.","[{'ForeName': 'Shadab A', 'Initials': 'SA', 'LastName': 'Rahman', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA 02115, United States of America; Division of Sleep Medicine, Harvard Medical School, Boston, MA 02115, United States of America. Electronic address: sarahman@rics.bwh.harvard.edu.""}, {'ForeName': 'Dharmishta', 'Initials': 'D', 'LastName': 'Rood', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA 02139, United States of America.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Trent', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA 02139, United States of America.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Solet', 'Affiliation': 'Division of Sleep Medicine, Harvard Medical School, Boston, MA 02115, United States of America; Department of Medicine, Cambridge Health Alliance, Cambridge, MA 02139, United States of America.'}, {'ForeName': 'Ellen J', 'Initials': 'EJ', 'LastName': 'Langer', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA 02139, United States of America.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA 02115, United States of America; Division of Sleep Medicine, Harvard Medical School, Boston, MA 02115, United States of America.""}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.109992']
292,32171721,A Randomized Trial of Recombinant Human C1-Esterase-Inhibitor in the Prevention of Contrast-Induced Kidney Injury.,"OBJECTIVES
This study sought to determine the efficacy profile and safety of recombinant human C1 esterase inhibitor (rhC1INH) in the prevention of contrast-associated acute kidney injury after elective coronary angiography.
BACKGROUND
Contrast-associated acute kidney injury is caused by tubular cytotoxicity and ischemia/reperfusion injury. rhC1INH is effective in reducing renal ischemia/reperfusion injury in experimental models.
METHODS
In this placebo-controlled, double-blind, single-center trial 77 patients with chronic kidney disease were randomized to receive 50 IU/kg rhC1INH before and 4 h after elective coronary angiography or placebo. The primary outcome was the peak change of urinary neutrophil gelatinase-associated lipocalin within 48 h, a surrogate marker of kidney injury.
RESULTS
Median peak change of urinary neutrophil gelatinase-associated lipocalin was lower in the rhC1INH group (4.7 ng/ml vs. 22.5 ng/ml; p = 0.038) in the per-protocol population but not in the modified intention-to-treat analysis, and in patients with percutaneous coronary interventions (median, 1.8 ng/ml vs. 26.2 ng/ml; p = 0.039 corresponding to a median proportion peak change of 11% vs. 205%; p = 0.002). The incidence of a cystatin C increase ≥10% within 24 h was lower in the rhC1INH group (16% vs. 33%; p = 0.045), whereas the frequency of contrast-associated acute kidney injury was comparable. Adverse events during a 3-month follow-up were similarly distributed.
CONCLUSIONS
Administration of rhC1INH before coronary angiography may attenuate renal injury as reflected by urinary neutrophil gelatinase-associated lipocalin and cystatin C. The safety profile of rhC1INH was favorable in a patient population with multiple comorbidities. (Recombinant Human C1 Esterase Inhibitor in the Prevention of Contrast-induced Nephropathy in High-risk Subjects [PROTECT]; NCT02869347).",2020,"RESULTS
Median peak change of urinary neutrophil gelatinase-associated lipocalin was lower in the rhC1INH group (4.7 ng/ml vs. 22.5 ng/ml; p = 0.038) in the per-protocol population but not in the modified intention-to-treat analysis, and in patients with percutaneous coronary interventions (median, 1.8 ng/ml vs. 26.2 ng/ml; p = ","['77 patients with chronic kidney disease', 'patient\xa0population with multiple comorbidities', 'contrast-associated acute kidney injury after elective coronary angiography']","['rhC1INH', 'Recombinant Human C1 Esterase Inhibitor', 'placebo', 'RhC1INH', '50 IU/kg rhC1INH before and 4\xa0h after elective coronary angiography or placebo', 'recombinant human C1 esterase inhibitor (rhC1INH', 'Recombinant Human C1-Esterase-Inhibitor']","['Median peak change of urinary neutrophil gelatinase-associated lipocalin', 'peak change of urinary neutrophil gelatinase-associated lipocalin within 48 h, a surrogate marker of kidney injury', 'Adverse events', 'frequency of contrast-associated acute kidney injury', 'incidence of a cystatin C']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}]","[{'cui': 'C2366367', 'cui_str': 'C1 esterase inhibitor (human)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439463', 'cui_str': 'international unit/kilogram'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0086589', 'cui_str': 'Surrogate Markers'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}]",,0.278511,"RESULTS
Median peak change of urinary neutrophil gelatinase-associated lipocalin was lower in the rhC1INH group (4.7 ng/ml vs. 22.5 ng/ml; p = 0.038) in the per-protocol population but not in the modified intention-to-treat analysis, and in patients with percutaneous coronary interventions (median, 1.8 ng/ml vs. 26.2 ng/ml; p = ","[{'ForeName': 'Anneza', 'Initials': 'A', 'LastName': 'Panagiotou', 'Affiliation': 'Division of Internal Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Marten', 'Initials': 'M', 'LastName': 'Trendelenburg', 'Affiliation': 'Division of Internal Medicine, University Hospital Basel, Basel, Switzerland; Department of Clinical Research and Department of Biomedicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Ingmar A F M', 'Initials': 'IAFM', 'LastName': 'Heijnen', 'Affiliation': 'Division of Medical Immunology, Laboratory Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Moser', 'Affiliation': 'Division of Internal Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Leo H', 'Initials': 'LH', 'LastName': 'Bonati', 'Affiliation': 'Division of Neurology and Stroke Center, Department of Clinical Research, University Hospital Basel and University of Basel, Basel Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Breidthardt', 'Affiliation': 'Division of Internal Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Fahrni', 'Affiliation': 'Department of Cardiology, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kaiser', 'Affiliation': 'Department of Cardiology, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Raban', 'Initials': 'R', 'LastName': 'Jeger', 'Affiliation': 'Department of Cardiology, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Osthoff', 'Affiliation': 'Division of Internal Medicine, University Hospital Basel, Basel, Switzerland; Department of Clinical Research and Department of Biomedicine, University of Basel, Basel, Switzerland. Electronic address: michael.osthoff@usb.ch.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.11.021']
293,32267727,The Effect of Physical Activity on Human Milk Macronutrient Content and Its Volume.,"Objective: There are multiple health benefits associated with both breastfeeding and practicing physical activity (PA). Therefore, it is likely that many women might want to engage in both. We designed the current randomized clinical trial to examine the effect of moderate- to high-intensity PA on human milk (HM) volume and macronutrient contents. Methods and Study Design: In this prospective, randomized, crossover clinical trial, we recruited 31 healthy mothers who had been exclusively breastfeeding their infants. Mothers expressed HM twice each day on 2 consecutive days-a day with PA (1-hour before and 1-hour after PA) and a control day without PA (at the exact same hours of the day). The order of days (with/without PA) was determined randomly. Macronutrients and energy contents of HM were analyzed using the Human Milk Analyzer (Miris AB, Uppsala, Sweden). PA was graded according to the Borg Rating of Perceived Exertion scale (RPE scale). Results: A total 124 HM samples from 31 mothers were analyzed. Moderate- to high-intensity PA affected neither macronutrients (fat, carbohydrates, protein) nor energy content. Milk volume remained unaffected by PA as well. Conclusions: Maternal PA does not affect HM volume or its macronutrient contents. Lactating mothers can be reassured regarding their breast milk volume and composition while practicing PA of moderate to high intensity.",2020,"Moderate- to high-intensity PA affected neither macronutrients (fat, carbohydrates, protein) nor energy content.","['A total 124 HM samples from 31 mothers were analyzed', 'Lactating mothers', '31 healthy mothers who had been exclusively breastfeeding their infants']","['moderate- to high-intensity PA', 'Physical Activity']","['Milk volume', 'human milk (HM) volume and macronutrient contents', 'Borg Rating of Perceived Exertion scale (RPE scale', 'Human Milk Macronutrient Content and Its Volume']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",31.0,0.0249137,"Moderate- to high-intensity PA affected neither macronutrients (fat, carbohydrates, protein) nor energy content.","[{'ForeName': 'Moria', 'Initials': 'M', 'LastName': ""Be'er"", 'Affiliation': ""Department of Pediatrics and Dana Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Mandel', 'Affiliation': ""Department of Neonatology, Dana Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Yelak', 'Affiliation': ""Department of Pediatrics and Dana Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Dana Lihi', 'Initials': 'DL', 'LastName': 'Gal', 'Affiliation': ""Department of Pediatrics and Dana Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Mangel', 'Affiliation': ""Department of Neonatology, Dana Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Lubetzky', 'Affiliation': ""Department of Pediatrics and Dana Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2019.0292']
294,31637972,Evaluation of an Extended Stroke Rehabilitation Service (EXTRAS): A Randomized Controlled Trial and Economic Analysis.,"Background and Purpose- There is limited evidence to guide rehabilitation to meet the longer term needs of stroke survivors. The clinical effectiveness and cost-effectiveness of an extended stroke rehabilitation service (EXTRAS) provided following early supported discharge were determined. Methods- EXTRAS was a pragmatic parallel-group observer-blind randomized controlled trial involving 19 UK centers. Patients with stroke were individually randomized to receive EXTRAS or usual care at discharge from early supported discharge. Five EXTRAS reviews were provided by an early supported discharge team member between one and 18 months, usually by telephone. Reviews consisted of a semi-structured interview assessing progress, rehabilitation needs, and service provision, with goal setting and action planning. The primary outcome was performance in extended activities of daily living (Nottingham EADL Scale) at 24 months post-randomization. The Nottingham EADL Scale is scored 0 to 66, with higher scores indicating better performance in these activities. Cost-effectiveness was estimated using resource utilization costs and Quality Adjusted Life Years. Analyses were intention to treat. Results- Between January 9, 2013 and October 26, 2015, 573 participants were randomized (EXTRAS, n=285; usual care, n=288). Mean 24 month Nottingham EADL Scale scores were EXTRAS (n=219) 40.0 (SD 18.1) and usual care (n=231) 37.2 (SD 18.5) giving an adjusted mean difference of 1.8 (95% CI, -0.7 to 4.2). 1155/1338 (86%) of expected EXTRAS reviews were undertaken. Over 24 months, the mean cost of resource utilization was lower in the intervention group: -£311 (-$450 [95% CI, -£3292 to £2787; -$4764 to $4033]). EXTRAS provided more Quality Adjusted Life Years (0.07 [95% CI, 0.01 to 0.12]). At current conventional thresholds of willingness to pay (£20 000 [$28 940] per Quality Adjusted Life Years), there was a 90% chance that EXTRAS could be considered cost-effective. Conclusions- EXTRAS did not significantly improve stroke survivors' performance in extended activities of daily living. However, given the impact on costs and Quality Adjusted Life Years, EXTRAS may be an affordable addition to improve stroke care. Clinical Trial Registration- URL: www.isrctn.com. Unique identifier: ISRCTN45203373.",2019,"EXTRAS provided more Quality Adjusted Life Years (0.07 [95% CI, 0.01 to 0.12]).","['Patients with stroke', 'Between January 9, 2013 and October 26, 2015, 573 participants were randomized (EXTRAS, n=285; usual care, n=288']","['EXTRAS', ' and Purpose', 'extended stroke rehabilitation service (EXTRAS', 'Extended Stroke Rehabilitation Service (EXTRAS']","['performance in extended activities of daily living (Nottingham EADL Scale', 'Mean 24 month Nottingham EADL Scale scores', 'resource utilization costs and Quality Adjusted Life Years', 'Cost-effectiveness', 'mean cost of resource utilization', 'Quality Adjusted Life Years', 'clinical effectiveness and cost-effectiveness', ""stroke survivors' performance""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4708164', 'cui_str': '573 (qualifier value)'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0204097', 'cui_str': 'Stroke Rehabilitation'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",573.0,0.242223,"EXTRAS provided more Quality Adjusted Life Years (0.07 [95% CI, 0.01 to 0.12]).","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rodgers', 'Affiliation': 'From the Stroke Research Group, Institute of Neuroscience (H.R., G.A.F., R.F., K.H., C.I.M.P., L.S.), Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Howel', 'Affiliation': 'Institute of Health and Society Newcastle University, Newcastle upon Tyne, UK (D.H., N.B., E. Stamp, L.V.), Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Nawaraj', 'Initials': 'N', 'LastName': 'Bhattarai', 'Affiliation': 'Institute of Health and Society Newcastle University, Newcastle upon Tyne, UK (D.H., N.B., E. Stamp, L.V.), Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Cant', 'Affiliation': 'Lay Investigator, Stroke Research Group, Institute of Neuroscience, Newcastle (R.C.), Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Drummond', 'Affiliation': 'School of Health Sciences, Nottingham University, United Kingdom (A.D.).'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Ford', 'Affiliation': 'From the Stroke Research Group, Institute of Neuroscience (H.R., G.A.F., R.F., K.H., C.I.M.P., L.S.), Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Forster', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, University of Leeds, United Kingdom (A.F.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Francis', 'Affiliation': 'From the Stroke Research Group, Institute of Neuroscience (H.R., G.A.F., R.F., K.H., C.I.M.P., L.S.), Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Hills', 'Affiliation': 'From the Stroke Research Group, Institute of Neuroscience (H.R., G.A.F., R.F., K.H., C.I.M.P., L.S.), Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Laverty', 'Affiliation': 'Stroke Northumbria, Northumbria Healthcare NHS Foundation Trust, North Tyneside, United Kingdom (H.R., A.-M.L., C.I.M.P.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McKevitt', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, United Kingdom (C.M., E. Stevens).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McMeekin', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, United Kingdom (P.M.).'}, {'ForeName': 'Christopher I M', 'Initials': 'CIM', 'LastName': 'Price', 'Affiliation': 'From the Stroke Research Group, Institute of Neuroscience (H.R., G.A.F., R.F., K.H., C.I.M.P., L.S.), Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Stamp', 'Affiliation': 'Institute of Health and Society Newcastle University, Newcastle upon Tyne, UK (D.H., N.B., E. Stamp, L.V.), Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Stevens', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, United Kingdom (C.M., E. Stevens).""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Institute of Health and Society Newcastle University, Newcastle upon Tyne, UK (D.H., N.B., E. Stamp, L.V.), Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shaw', 'Affiliation': 'From the Stroke Research Group, Institute of Neuroscience (H.R., G.A.F., R.F., K.H., C.I.M.P., L.S.), Newcastle University, Newcastle upon Tyne, United Kingdom.'}]",Stroke,['10.1161/STROKEAHA.119.024876']
295,32270862,Clinical Predictors of Liver Fibrosis Presence and Progression in HIV-Associated NAFLD.,"BACKGROUND
Nonalcoholic fatty disease (NAFLD) affects over one-third of people living with HIV. Nonetheless, the natural history of HIV-associated NAFLD is poorly understood, including which patients are most likely to have a progressive disease course.
METHODS
We leveraged a randomized trial of the growth hormone-releasing hormone analogue tesamorelin to treat NAFLD in HIV. Sixty-one participants with HIV-associated NAFLD were randomized to tesamorelin or placebo for 12 months. Participants underwent liver biopsy at baseline and 12 months with histologic evaluation performed by an expert pathologist blinded to treatment.
RESULTS
In all participants with baseline biopsies (n=58), 43% had hepatic fibrosis. Individuals with fibrosis had higher NAFLD Activity Score (NAS) (3.6±2.0 vs. 2.0±0.8, P<0.0001) and visceral fat content (284±91 cm2 vs. 212±95 cm2, P=0.005), but no difference in hepatic fat or BMI. Among placebo-treated participants with paired biopsies (n=24), 38% had hepatic fibrosis progression over 12 months. For each 25 cm2 higher visceral fat at baseline, the odds of fibrosis progression increased by 37% (OR 1.37, 95% CI 1.03, 2.07). There was no difference in baseline NAS score between fibrosis progressors and non-progressors, though NAS score rose over time in the progressor group (1.1±0.8 vs. -0.5±0.6, P<0.0001).
CONCLUSIONS
In this longitudinal study of HIV-associated NAFLD, high rates of hepatic fibrosis and progression were observed. Visceral adiposity was identified as a novel clinical predictor of worsening fibrosis. In contrast, baseline histologic characteristics were not found to relate to fibrosis changes over time. Further studies are needed to identify additional biomarkers of accelerated disease.",2020,"Individuals with fibrosis had higher NAFLD Activity Score (NAS) (3.6±2.0 vs. 2.0±0.8, P<0.0001) and visceral fat content (284±91 cm2 vs. 212±95 cm2, P=0.005), but no difference in hepatic fat or BMI.","['HIV', 'Sixty-one participants with HIV-associated NAFLD', 'people living with HIV', 'participants with baseline biopsies (n=58), 43% had hepatic fibrosis']","['growth hormone-releasing hormone analogue tesamorelin', 'tesamorelin or placebo', 'placebo']","['visceral fat content', 'hepatic fat or BMI', 'hepatic fibrosis progression', 'NAFLD Activity Score (NAS', 'baseline NAS score', 'NAS score rose over time', 'fibrosis progression', 'Visceral adiposity']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}]","[{'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C1876200', 'cui_str': 'tesamorelin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027446', 'cui_str': 'National Academy of Sciences (U.S.)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",61.0,0.217521,"Individuals with fibrosis had higher NAFLD Activity Score (NAS) (3.6±2.0 vs. 2.0±0.8, P<0.0001) and visceral fat content (284±91 cm2 vs. 212±95 cm2, P=0.005), but no difference in hepatic fat or BMI.","[{'ForeName': 'Lindsay T', 'Initials': 'LT', 'LastName': 'Fourman', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Takara L', 'Initials': 'TL', 'LastName': 'Stanley', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Zheng', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Chelsea S', 'Initials': 'CS', 'LastName': 'Pan', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Meghan N', 'Initials': 'MN', 'LastName': 'Feldpausch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Purdy', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Aepfelbacher', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Buckless', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Tsao', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Corey', 'Affiliation': 'Liver Center, Gastroenterology Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Chung', 'Affiliation': 'Liver Center, Gastroenterology Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Torriani', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kleiner', 'Affiliation': 'Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Hadigan', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa382']
296,32259823,The Effect of a Thixotropic Nasal Gel on Nasal Symptoms and Inflammatory Biomarkers in Seasonal Allergic Rhinitis.,"BACKGROUND
Drug-free viscous nasal applications have been shown to reduce nasal symptoms in individuals with seasonal allergic rhinitis (SAR). Nascum®-Plus (NP), a commercially available thixotropic gel, has been designed to reduce dryness and soreness of the nasal mucosa and prevent the absorption of small particles.
OBJECTIVES
The aim of this study was to assess the efficacy of single-dose NP in treating nasal symptoms and secretion during challenge in an allergen challenge chamber (ACC). Furthermore, the effect of this treatment on biomarkers and immune cells of the allergic cascade were measured.
METHODS
This open-label, cross-over, sequence-randomized, monocentric trial randomized 18 adults with SAR and a positive skin prick test reaction to Dactylis glomerata pollen to receive NP or no treatment during two 4-h ACC sessions 3 weeks apart. On Day 1, 9 subjects were challenged for 4 h with treatment, the other 9 without treatment, and vice versa on Day 22. Nasal lavage fluid and nasal filter eluate samples were obtained pre, 2, and 18 h post challenge in the ACC.
RESULTS
NP significantly reduced nasal symptoms, assessed by total nasal symptom score (p < 0.001), and minimized nasal secretion (p = 0.047), while no significant effect on biomarkers and immune cells in the nasal fluid was observed. The treatment was safe and well-tolerated.
CONCLUSIONS
The physical barrier built by NP nasal gel can be safely applied in patients with allergic rhinitis. It reduces allergic nasal symptoms and secretion, but application of a single dose does not affect local inflammatory biomarkers.",2020,"RESULTS
NP significantly reduced nasal symptoms, assessed by total nasal symptom score (p < 0.001), and minimized nasal secretion (p = 0.047), while no significant effect on biomarkers and immune cells in the nasal fluid was observed.","['patients with allergic rhinitis', 'individuals with seasonal allergic rhinitis (SAR', '18 adults with SAR and a positive skin prick test reaction to Dactylis glomerata pollen to receive NP or no treatment during two 4-h ACC sessions 3 weeks apart', 'Seasonal Allergic Rhinitis']","['single-dose NP', 'Nascum®-Plus (NP', 'Thixotropic Nasal Gel']","['biomarkers and immune cells', 'allergic nasal symptoms and secretion', 'safe and well-tolerated', 'total nasal symptom score', 'Nasal Symptoms and Inflammatory Biomarkers', 'minimized nasal secretion', 'nasal symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0440327', 'cui_str': 'Orchard grass pollen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0991526', 'cui_str': 'Nasal gel'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]",18.0,0.0451303,"RESULTS
NP significantly reduced nasal symptoms, assessed by total nasal symptom score (p < 0.001), and minimized nasal secretion (p = 0.047), while no significant effect on biomarkers and immune cells in the nasal fluid was observed.","[{'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Struß', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Badorrek', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Mattern', 'Affiliation': 'M et P Pharma AG, Emmetten, Switzerland.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Mattern', 'Affiliation': 'M et P Pharma AG, Emmetten, Switzerland.'}, {'ForeName': 'Jens M', 'Initials': 'JM', 'LastName': 'Hohlfeld', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany, jens.hohlfeld@item.fraunhofer.de.'}]",International archives of allergy and immunology,['10.1159/000506129']
297,31515154,"Cabazitaxel plus carboplatin for the treatment of men with metastatic castration-resistant prostate cancers: a randomised, open-label, phase 1-2 trial.","BACKGROUND
Taxane-platinum combinations have shown promising activity in metastatic castration-resistant prostate cancers in single-group clinical studies but not in randomised trials. Distinct biological subsets of the disease might derive the greatest benefit from the addition of platinum. We aimed to determine whether adding carboplatin to cabazitaxel would improve the outcomes of men with metastatic castration-resistant prostate cancer.
METHODS
We did a phase 1-2, open label, randomised study at two centres in men with progressive metastatic castration-resistant prostate cancer. In phase 1, patients received intravenous cabazitaxel 20-25 mg/m 2 and intravenous carboplatin area under the curve (AUC) 3-4 mg/mL per min every 21 days. The maximum tolerated dose was defined as the highest dose cohort studied in which one of six or fewer patients experienced a dose-limiting toxicity. In phase 2, patients were randomly assigned (1:1) centrally by a computerised algorithm to intravenous cabazitaxel 25 mg/m 2 with or without intravenous carboplatin AUC 4 mg/mL per min. All patients received growth factor support and oral prednisone 10 mg daily. The primary endpoints were the maximum tolerated dose of the combination in phase 1 and investigator-assessed progression-free survival in phase 2. This trial is registered at ClinicalTrials.gov, number NCT01505868.
FINDINGS
Between Aug 17, 2012, and May 11, 2015, nine patients completed phase 1 as planned, and 160 were randomly assigned to cabazitaxel (n=79) or cabazitaxel plus carboplatin (n=81) in phase 2. During phase I, grade 3 adverse events were anaemia (n=2), fatigue (n=1), thrombocytopenia (n=1), hypomagnesaemia (n=1), diarrhoea (n=1), hypokalaemia (n=1), anorexia (n=1), and dehydration (n=1), and no grade 4 adverse events occurred. No dose-limiting toxicities were observed, therefore, a maximum tolerated dose of cabazitaxel of 25 mg/m 2 and carboplatin of AUC 4 mg/mL per min was selected for phase 2. At a median follow-up of 31·0 months (IQR 20·5-37·1), the combination improved the median progression-free survival from 4·5 months (95% CI 3·5-5·7) to 7·3 months (95% CI 5·5-8·2; hazard ratio 0·69, 95% CI 0·50-0·95, p=0·018). In the phase 2 study, the most common grade 3-5 adverse events were fatigue (7 [9%] of 79 in the cabazitaxel group vs 16 [20%] of 81 in the combination group), anaemia (3 [4%] vs 19 [23%]), neutropenia (3 [4%] vs 13 [16%]), and thrombocytopenia (1 [1%] vs 11 [14%]). There were no treatment-related deaths.
INTERPRETATION
Carboplatin added to cabazitaxel showed improved clinical efficacy compared with cabazitaxel alone for men with metastatic castration-resistant prostate cancer. Although adverse events were more common with the combination, the treatment was safe and generally well tolerated. Our data suggest that taxane-platinum combinations have a clinically beneficial role in advanced prostate cancer and a randomised phase 3 study is planned.
FUNDING
Sanofi Genzyme, University of Texas MD Anderson Cancer Center Prostate Cancer Moon Shot Program, and Solon Scott III Prostate Cancer Research Fund.",2019,"There were no treatment-related deaths.
","['men with metastatic castration-resistant prostate cancer', 'Between Aug 17, 2012, and May 11, 2015', 'men with progressive metastatic castration-resistant prostate cancer', 'men with metastatic castration-resistant prostate cancers']","['Taxane-platinum combinations', 'Carboplatin', 'Cabazitaxel plus carboplatin', 'cabazitaxel', 'cabazitaxel plus carboplatin', 'taxane-platinum combinations', 'intravenous cabazitaxel 20-25 mg/m 2 and intravenous carboplatin', 'carboplatin to cabazitaxel', 'cabazitaxel alone', 'cabazitaxel 25 mg/m 2 with or without intravenous carboplatin AUC 4 mg/mL per min', 'growth factor support and oral prednisone']","['clinical efficacy', 'safe and generally well tolerated', 'thrombocytopenia', 'anaemia', 'anaemia (n=2), fatigue (n=1), thrombocytopenia (n=1), hypomagnesaemia (n=1), diarrhoea (n=1), hypokalaemia (n=1), anorexia (n=1), and dehydration (n=1), and no grade 4 adverse events', 'neutropenia', 'median progression-free survival', 'maximum tolerated dose of the combination in phase 1 and investigator-assessed progression-free survival', 'maximum tolerated dose']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]","[{'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia (disorder)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}]",,0.212863,"There were no treatment-related deaths.
","[{'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Corn', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Elisabeth I', 'Initials': 'EI', 'LastName': 'Heath', 'Affiliation': 'Department of Oncology, Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, MI, USA.'}, {'ForeName': 'Amado', 'Initials': 'A', 'LastName': 'Zurita', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Ramesh', 'Affiliation': 'Department of Genetics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lianchun', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Sei', 'Affiliation': 'Department of Genetics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Li-Ning-Tapia', 'Affiliation': 'Department of Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Shi-Ming', 'Initials': 'SM', 'LastName': 'Tu', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sumit K', 'Initials': 'SK', 'LastName': 'Subudhi', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Efstathiou', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Thompson', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Troncoso', 'Affiliation': 'Department of Anatomical Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Navin', 'Affiliation': 'Department of Genetics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Logothetis', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Aparicio', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: aaparicio@mdanderson.org.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30408-5']
298,31689007,"Dietary Weight Loss, Exercise, and Inflammation in Older Adults with Overweight or Obesity and Cardiometabolic Disease.","OBJECTIVE
This study aimed to examine exercise modality during weight loss on change in inflammation among older adults with overweight or obesity and cardiometabolic disease.
METHODS
A total of 222 older adults with a mean (SD) age of 66.9 (4.7) years and a mean (SD) BMI of 33.5 (3.5) kg/m 2 were randomized to weight loss (WL; n = 68), WL plus aerobic training (WL + AT; n = 79), or WL plus resistance training (WL + RT; n = 75) for 18 months. C-reactive protein (CRP) and interleukin-6 were measured at baseline, 6 months, and 18 months.
RESULTS
All groups lost significant weight from baseline to 18 months, with average adjusted changes of -5.5% for WL, -9.0% for WL + AT, and -10.1% for WL + RT. WL + RT and WL + AT lost significantly more weight than WL (P < 0.05). At 18 months, CRP values in WL + RT were significantly lower than WL (2.25 pg/mL vs. 3.38 pg/mL; P = 0.004). The only difference in interleukin-6 was that at 18 months, WL + RT was lower than WL + AT (2.32 pg/mL vs. 2.75 pg/mL; P = 0.03).
CONCLUSIONS
The addition of RT during WL was more effective at reducing levels of CRP than WL. Although results were in the expected direction, there was no difference in CRP between WL and WL + AT.",2019,"At 18 months, CRP values in WL + RT were significantly lower than WL (2.25 pg/mL vs. 3.38 pg/mL; P = 0.004).","['222 older adults with a mean (SD) age of 66.9 (4.7) years and a mean (SD) BMI of 33.5 (3.5) kg/m 2 were randomized to weight loss (WL; n\u2009=\u200968', 'Older Adults with Overweight or Obesity and Cardiometabolic Disease', 'older adults with overweight or obesity and cardiometabolic disease']","['WL plus aerobic training (WL\u2009+\u2009AT; n\u2009=\u200979), or WL plus resistance training (WL\u2009+\u2009RT', 'exercise modality']","['C-reactive protein (CRP) and interleukin-6', 'CRP', 'interleukin-6', 'CRP values', 'Dietary Weight Loss, Exercise, and Inflammation']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",222.0,0.0556616,"At 18 months, CRP values in WL + RT were significantly lower than WL (2.25 pg/mL vs. 3.38 pg/mL; P = 0.004).","[{'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Health & Exercise Science, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Marsh', 'Affiliation': 'Department of Health & Exercise Science, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fanning', 'Affiliation': 'Department of Health & Exercise Science, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Walkup', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': 'Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22600']
299,31089727,An electronic health record-based interoperable eReferral system to enhance smoking Quitline treatment in primary care.,"OBJECTIVE
The study sought to determine whether interoperable, electronic health record-based referral (eReferral) produces higher rates of referral and connection to a state tobacco quitline than does fax-based referral, thus addressing low rates of smoking treatment delivery in health care.
MATERIALS AND METHODS
Twenty-three primary care clinics from 2 healthcare systems (A and B) in Wisconsin were randomized, unblinded, over 2016-2017, to 2 smoking treatment referral methods: paper-based fax-to-quit (system A =6, system B = 6) or electronic (eReferral; system A = 5, system B = 6). Both methods referred adult patients who smoked to the Wisconsin Tobacco Quitline. A total of 14 636 smokers were seen in the 2 systems (system A: 54.5% women, mean age 48.2 years; system B: 53.8% women, mean age 50.2 years).
RESULTS
Clinics with eReferral, vs fax-to-quit, referred a higher percentage of adult smokers to the quitline: system A clinic referral rate = 17.9% (95% confidence interval [CI], 17.2%-18.5%) vs 3.8% (95% CI, 3.5%-4.2%) (P < .001); system B clinic referral rate = 18.9% (95% CI, 18.3%-19.6%) vs 5.2% (95% CI, 4.9%-5.6%) (P < .001). Average rates of quitline connection were higher in eReferral than F2Q clinics: system A = 5.4% (95% CI, 5.0%-5.8%) vs 1.3% (95% CI, 1.1%-1.5%) (P < .001); system B = 5.3% (95% CI, 5.0%-5.7%) vs 2.0% (95% CI, 1.8%-2.2%) (P < .001).
DISCUSSION
Electronic health record-based eReferral provided an effective, closed-loop, interoperable means of referring patients who smoke to telephone quitline services, producing referral rates 3-4 times higher than the current standard of care (fax referral), including especially high rates of referral of underserved individuals.
CONCLUSIONS
eReferral may help address the challenge of providing smokers with treatment for tobacco use during busy primary care visits.ClinicalTrials.gov; No. NCT02735382.",2019,Average rates of quitline connection were higher in eReferral than F2Q clinics,"['primary care', 'Twenty-three primary care clinics from 2 healthcare systems (A and B) in Wisconsin were randomized, unblinded, over 2016-2017, to 2', 'A total of 14 636 smokers were seen in the 2 systems (system A: 54.5% women, mean age 48.2 years; system B: 53.8% women, mean age 50.2 years', 'adult patients who smoked to the Wisconsin Tobacco Quitline']","['smoking treatment referral methods: paper-based fax-to-quit (system A =6, system B = 6) or electronic (eReferral; system A = 5, system B = 6', 'interoperable, electronic health record-based referral (eReferral']","['Average rates of quitline connection', 'system B clinic referral rate']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085205', 'cui_str': 'Fax'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}]","[{'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}]",14636.0,0.187087,Average rates of quitline connection were higher in eReferral than F2Q clinics,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fiore', 'Affiliation': 'Center for Tobacco Research and Intervention and Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Adsit', 'Affiliation': 'Center for Tobacco Research and Intervention and Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Zehner', 'Affiliation': 'Center for Tobacco Research and Intervention and Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McCarthy', 'Affiliation': 'Center for Tobacco Research and Intervention and Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Lundsten', 'Affiliation': 'Department of Community and Preventive Care Services, Gundersen Health System, La Crosse, Wisconsin, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hartlaub', 'Affiliation': 'Family and Preventive Medicine, Brown Deer, Quality and Safety, Primary Care, Ascension Medical Group, Brown Deer, Wisconsin, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Mahr', 'Affiliation': 'Department of Community and Preventive Care Services, Gundersen Health System, La Crosse, Wisconsin, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Gorrilla', 'Affiliation': 'Center for Tobacco Research and Intervention and Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Skora', 'Affiliation': 'Center for Tobacco Research and Intervention and Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Intervention and Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz044']
300,31582360,"Anti-influenza immune plasma for the treatment of patients with severe influenza A: a randomised, double-blind, phase 3 trial.","BACKGROUND
Infection with influenza virus causes substantial morbidity and mortality globally, although antiviral treatments are available. Previous studies have suggested that anti-influenza immune plasma could be beneficial as treatment, but they were not designed as randomised, blinded, placebo-controlled trials. Therefore, we aimed to prospectively evaluate the clinical efficacy of high-titre immune plasma compared with standard low-titre plasma to improve outcomes in patients with severe influenza A infection.
METHODS
We did this randomised, double-blind, phase 3 trial at 41 US medical centres to assess the efficacy of high-titre anti-influenza plasma (haemagglutination inhibition antibody titre ≥1:80) compared with low-titre plasma (≤1:10). Children and adults with PCR-confirmed influenza A infection, a National Early Warning score of 3 or greater, and onset of illness within 6 days before randomisation were eligible. Patients were randomly assigned (2:1) using an interactive web response system to receive either two units (or paediatric equivalent) of high-titre plasma (high-titre group) or low-titre plasma (low-titre group), and were followed up for 28 days from randomisation. High-titre and low-titre plasma had the same appearance. Randomisation was stratified by severity (in intensive care unit, not in intensive care but requiring supplemental oxygen, or not in intensive care and not requiring supplemental oxygen) and age (<18 years and ≥18 years). All participants, site staff, and the study team were masked to treatment allocation until after the final database lock. The primary endpoint was clinical status assessed by a six-point ordinal scale on day 7 (death, in intensive care, hospitalised but requiring supplemental oxygen, hospitalised not requiring supplemental oxygen, discharged but unable to resume normal activities, and discharged with full resumption of normal activities) analysed in a proportional odds model (an odds ratio [OR] >1 indicates improvement in clinical status across all categories for the high-titre vs the low-titre group). The primary analysis was done in the intention-to-treat population, excluding two participants who did not receive plasma. This trial is registered with ClinicalTrials.gov, NCT02572817.
FINDINGS
Participants were recruited between Jan 26, 2016, and April 19, 2018. Of 200 participants enrolled (177 adults and 23 children), 140 met the criteria for randomisation and were assigned to the high-titre group (n=92) or to the control low-titre group (n=48). One participant from each group did not receive plasma. At baseline, 60 (43%) of 138 participants were in intensive care and 55 (71%) of 78 participants who were not in intensive care required oxygen. 93% of planned plasma infusions were completed. The study was terminated in July, 2018, when independent efficacy analysis showed low conditional power to detect an effect of high-titre plasma even if full accrual (150 participants) was achieved. The proportional OR for improved clinical status on day 7 was 1·22 (95% CI 0·65-2·29, p=0·54). 47 (34%) of 138 participants experienced 88 serious adverse events: 32 (35%) with 60 events in the high-titre group and 15 (32%) with 28 events in the low-titre group. The most common serious adverse events were acute respiratory distress syndrome (ARDS; four [4%] vs two [4%]), allergic transfusion reactions (two [2%] vs two [4%]), and respiratory distress (three [3%] vs none). 65 (47%) participants experienced 183 adverse events: 42 (46%) with 126 events in the high-titre group and 23 (49%) with 57 events in the low-titre group. The most common adverse events were anaemia (four [3%] vs two [4%]) and ARDS (four [3%] vs three [5%]). Ten patients died during the study (six [7%] in the high-titre group vs four [9%] in the low-titre group, p=0·73). The most common cause of death was worsening of acute respiratory distress syndrome (two [2%] vs two [4%] patients).
INTERPRETATION
High-titre anti-influenza plasma conferred no significant benefit over non-immune plasma. Although our study did not have the precision to rule out a small, clinically relevant effect, the benefit is insufficient to justify the use of immune plasma for treating patients with severe influenza A.
FUNDING
National Institute of Allergy and Infectious Diseases of the National Institutes of Health (Bethesda, MD, USA).",2019,"The proportional OR for improved clinical status on day 7 was 1·22 (95% CI 0·65-2·29, p=0·54).","['patients with severe influenza A', '200 participants enrolled (177 adults and 23 children), 140 met the criteria for randomisation and were assigned to the high-titre group (n=92) or to the control low-titre group (n=48', 'patients with severe influenza A infection', '138 participants were in intensive care and 55 (71%) of 78 participants who were not in intensive care required oxygen', 'Children and adults with PCR-confirmed influenza A infection, a National Early Warning score of 3 or greater, and onset of illness within 6 days before randomisation were eligible', 'Participants were recruited between Jan 26, 2016, and April 19, 2018']","['interactive web response system to receive either two units (or paediatric equivalent) of high-titre plasma (high-titre group) or low-titre plasma (low-titre group', 'intensive care but requiring supplemental oxygen, or not in intensive care and not requiring supplemental oxygen', 'Anti-influenza immune plasma', 'standard low-titre plasma']","['anaemia', 'respiratory distress', 'ARDS', 'acute respiratory distress syndrome', 'clinical status assessed by a six-point ordinal scale on day 7 (death, in intensive care, hospitalised but requiring supplemental oxygen, hospitalised not requiring supplemental oxygen, discharged but unable to resume normal activities, and discharged with full resumption of normal activities', 'allergic transfusion reactions', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2076600', 'cui_str': 'Influenza caused by Influenza A virus subtype H1N1'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0085559'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0277793', 'cui_str': 'Onset of illness'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0085559'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0085559'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1283787', 'cui_str': 'Allergic transfusion reaction (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",200.0,0.445549,"The proportional OR for improved clinical status on day 7 was 1·22 (95% CI 0·65-2·29, p=0·54).","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA. Electronic address: jbeigel@niaid.nih.gov.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Aga', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Marie-Carmelle', 'Initials': 'MC', 'LastName': 'Elie-Turenne', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Josalyn', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Tebas', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Clark', 'Affiliation': 'Beaumont Hospital-Royal Oak, Royal Oak, MI, USA.'}, {'ForeName': 'Jordan P', 'Initials': 'JP', 'LastName': 'Metcalf', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ozment', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Kanakatte', 'Initials': 'K', 'LastName': 'Raviprakash', 'Affiliation': 'Naval Medical Research Center, Silver Spring, MD, USA.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Beeler', 'Affiliation': 'Leidos Biomedical Research, Frederick, MD, USA.'}, {'ForeName': 'H Preston', 'Initials': 'HP', 'LastName': 'Holley', 'Affiliation': 'Leidos Biomedical Research, Frederick, MD, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Warner', 'Affiliation': 'Social & Scientific Systems, Silver Spring, MD, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Chorley', 'Affiliation': 'Leidos Biomedical Research, Frederick, MD, USA.'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hughes', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Davey', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30199-7']
301,32260313,Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial.,"Monopolar dielectric radiofrequency (MDR) is a non-invasive treatment for pain based on the local application of electromagnetic signals. The study's goal was to analyze the effects of MDR on the symptoms of fibromyalgia. For this aim, a randomized controlled trial was conducted on 66 female participants (aged 47 17.7) diagnosed with fibromyalgia. Participants were randomly allocated to either an experimental group ( n = 23), which received eight 20-minute sessions of MDR; a sham group, which received the same number of sessions of a sham MDR therapy ( n = 22); or a control group ( n = 21), which received usual care. The outcome variables included pain measured by the visual analogue scale (VAS), score on the hospital anxiety and depression scale (HADS) and quality of life measured by the combined index of fibromyalgia severity (ICAF). A large effect size was observed for the local pain (R 2 = 0.46), total ICAF (R 2 = 0.42) and ICAF physical factor scores (R 2 = 0.38). Significant mean differences were found for the local pain ( p = 0.025) and ICAF physical factor ( p = 0.031) scores of the experimental group in comparison with the sham group. No statistically significant differences between groups were found in HADS. In conclusion, MDR is more effective than either sham treatment or usual care in the short-term improvement of pain and the physical wellbeing of participants with fibromyalgia.",2020,Significant mean differences were found for the local pain ( p = 0.025) and ICAF physical factor ( p = 0.031) scores of the experimental group in comparison with the sham group.,"['66 female participants (aged 47 17.7) diagnosed with fibromyalgia', 'participants with fibromyalgia', 'Fibromyalgia']","['Monopolar Dielectric Radiofrequency Signals', 'sham MDR therapy', 'MDR', 'Monopolar dielectric radiofrequency (MDR', 'control group ( n = 21), which received usual care']","['ICAF physical factor', 'ICAF physical factor scores', 'total ICAF', 'local pain', 'pain measured by the visual analogue scale (VAS), score on the hospital anxiety and depression scale (HADS) and quality of life measured by the combined index of fibromyalgia severity (ICAF', 'pain and the physical wellbeing', 'HADS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0242640', 'cui_str': 'Multiple-drug resistance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0048008', 'cui_str': ""4-amino-4'-hydroxylaminodiphenylsulfone""}]",66.0,0.106082,Significant mean differences were found for the local pain ( p = 0.025) and ICAF physical factor ( p = 0.031) scores of the experimental group in comparison with the sham group.,"[{'ForeName': 'Alfonso Javier', 'Initials': 'AJ', 'LastName': 'Ibáñez-Vera', 'Affiliation': 'Department of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Jerónimo Carmelo', 'Initials': 'JC', 'LastName': 'García-Romero', 'Affiliation': 'Department of Human Physiology, Human Histology, Pathological Anatomy and Physical Education and Sports, University of Málaga, 29071 Andalucía TECH, Spain.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Alvero-Cruz', 'Affiliation': 'Department of Human Physiology, Human Histology, Pathological Anatomy and Physical Education and Sports, University of Málaga, 29071 Andalucía TECH, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Lomas-Vega', 'Affiliation': 'Department of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17072465']
302,30938751,Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial.,"OBJECTIVE
In the context of patient broad consent for future research uses of their identifiable health record data, we compare the effectiveness of interactive trust-enhanced e-consent, interactive-only e-consent, and standard e-consent (no interactivity, no trust enhancement).
MATERIALS AND METHODS
A randomized trial was conducted involving adult participants making a scheduled primary care visit. Participants were randomized into 1 of the 3 e-consent conditions. Primary outcomes were patient-reported satisfaction with and subjective understanding of the e-consent. Secondary outcomes were objective knowledge, perceived voluntariness, trust in medical researchers, consent decision, and time spent using the application. Outcomes were assessed immediately after use of the e-consent and at 1-week follow-up.
RESULTS
Across all conditions, participants (N = 734) reported moderate-to-high satisfaction with consent (mean 4.3 of 5) and subjective understanding (79.1 of 100). Over 94% agreed to share their health record data. No statistically significant differences in outcomes were observed between conditions. Irrespective of condition, black participants and those with lower education reported lower satisfaction, subjective understanding, knowledge, perceived voluntariness, and trust in medical researchers, as well as spent more time consenting.
CONCLUSIONS
A large majority of patients were willing to share their identifiable health records for research, and they reported positive consent experiences. However, incorporating optional additional information and messages designed to enhance trust in the research process did not improve consent experiences. To improve poorer consent experiences of racial and ethnic minority participants and those with lower education, other novel consent technologies and processes may be valuable. (An Interactive Patient-Centered Consent for Research Using Medical Records; NCT03063268).",2019,"Irrespective of condition, black participants and those with lower education reported lower satisfaction, subjective understanding, knowledge, perceived voluntariness, and trust in medical researchers, as well as spent more time consenting.
",['adult participants making a scheduled primary care visit'],"['interactive trust-enhanced e-consent, interactive-only e-consent, and standard e-consent (no interactivity, no trust enhancement', 'interactive trust-enhanced electronic consent']","['moderate-to-high satisfaction with consent', 'objective knowledge, perceived voluntariness, trust in medical researchers, consent decision, and time spent using the application', 'patient-reported satisfaction with and subjective understanding of the e-consent', 'satisfaction, subjective understanding, knowledge, perceived voluntariness, and trust in medical researchers']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",,0.0533203,"Irrespective of condition, black participants and those with lower education reported lower satisfaction, subjective understanding, knowledge, perceived voluntariness, and trust in medical researchers, as well as spent more time consenting.
","[{'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Harle', 'Affiliation': 'Department of Health Policy and Management, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Golembiewski', 'Affiliation': 'Department of Health Policy and Management, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Kiarash P', 'Initials': 'KP', 'LastName': 'Rahmanian', 'Affiliation': 'Department of Community Health and Family Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Babette', 'Initials': 'B', 'LastName': 'Brumback', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Janice L', 'Initials': 'JL', 'LastName': 'Krieger', 'Affiliation': 'Department of Advertising, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Goodman', 'Affiliation': 'Institute for Bioethics and Health Policy, Miller School of Medicine, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Arch G', 'Initials': 'AG', 'LastName': 'Mainous', 'Affiliation': 'Department of Community Health and Family Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Ray E', 'Initials': 'RE', 'LastName': 'Moseley', 'Affiliation': 'Department of Community Health and Family Medicine, University of Florida, Gainesville, Florida, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz015']
303,31674641,Bone Mineral Density Response With Denosumab in Combination With Standard or High-Dose Teriparatide: The DATA-HD RCT.,"CONTEXT
In the Denosumab and High-Dose Teriparatide Administration (DATA-HD) study, we reported that 15 months of combined high-dose (HD) teriparatide and denosumab increased mean areal bone mineral density (aBMD) at the hip and spine more than combined denosumab and standard-dose (SD) teriparatide.
OBJECTIVE
In the current analysis, we compare the individual rates of aBMD response between the treatment groups.
DESIGN
Single-site, open-label, randomized controlled trial in which postmenopausal women received either teriparatide 20-μg daily (SD) or 40-μg daily (HD) given months 0 through 9, overlapped with denosumab 60 mg, given months 3 through 15 (15 months' total duration). The proportion of participants in the SD and HD groups experiencing total hip, femoral neck, and lumbar spine aBMD gains of >3%, >6%, and >9% were compared.
PARTICIPANTS
Postmenopausal women with osteoporosis completing all study visits (n = 60).
MAIN OUTCOME MEASURE(S)
aBMD (dual x-ray absorptiometry).
RESULTS
At the end of the 15-month treatment period, a higher proportion of women in the HD group had aBMD increases >3% (83% vs. 58%, P = .037) and >6% (45% vs. 19%, P = .034) at the total hip, and >3% at the femoral neck (86% vs. 63%, P = .044). At the lumbar spine, >3% response rates were similar, whereas the >6% and >9% response rates were greater in the HD group (100% vs. 79%, P = .012 and 93% vs. 59%, P = .003, respectively).
CONCLUSION
Compared with the SD regimen, more women treated with the HD regimen achieved clinically meaningful and rapid gains in hip and spine aBMD. These results suggest that this approach may provide unique benefits in the treatment of postmenopausal osteoporosis.",2020,"Compared with the SD regimen, more women treated with the HD regimen achieved clinically meaningful and rapid gains in hip and spine aBMD.","['postmenopausal women', 'Postmenopausal women with osteoporosis completing all study visits (n = 60']","['combined high-dose (HD) teriparatide and denosumab', 'teriparatide 20-μg daily (SD) or 40-μg daily (HD) given months 0-9, overlapped with denosumab 60-mg', 'denosumab in combination with\xa0standard or high-dose teriparatide']","['mean areal bone mineral density (aBMD', 'BMD', 'clinically meaningful and rapid gains in hip and spine aBMD', 'femoral neck', 'total hip, femoral neck, and lumbar spine aBMD gains', 'response rates', 'aBMD (dual x-ray absorptiometry', 'aBMD response', 'Bone mineral density response']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0185027', 'cui_str': 'Imbrication (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]",,0.0653879,"Compared with the SD regimen, more women treated with the HD regimen achieved clinically meaningful and rapid gains in hip and spine aBMD.","[{'ForeName': 'Sabashini K', 'Initials': 'SK', 'LastName': 'Ramchand', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA.'}, {'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'David', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA.'}, {'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Leder', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA.'}, {'ForeName': 'Joy N', 'Initials': 'JN', 'LastName': 'Tsai', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz163']
304,31941445,Anticipated HIV stigma among HIV negative men who have sex with men in China: a cross-sectional study.,"BACKGROUND
Anticipated HIV stigma, i.e., the expectation of adverse experiences from one's seroconversion, is associated with both negative psychological and behavioral outcomes. We know little about anticipated HIV stigma's relationship with emerging technologies, such as HIV self-testing (HIVST) and online sex-seeking platforms, that have become popular among populations that are disproportionately affected by HIV/AIDS. This study examined correlates of anticipated HIV stigma among Chinese men who have sex with men (MSM).
METHODS
In July 2016, MSM, who were ≥ 16 years old and self-reported as HIV negative or unknown, were recruited from a gay mobile phone application in China. Information regarding socio-demographics, sexual behaviors, sexual health service utilization, and anticipated HIV stigma were collected. Anticipated HIV stigma (i.e., negative attitude toward future stigmatization of HIV seroconversion by others) was measured as the mean score from a 7-item Likert-scale ranging from 1 (low) to 4 (high). Generalized linear models were conducted to examine the factors associated with the anticipated HIV stigma scores.
RESULTS
Overall, 2006 men completed the survey. Most men completed high school (1308/2006, 65.2%) and had an annual personal income of ≤9200 USD (1431/2006, 71.3%). The mean anticipated HIV stigma score for the participants was 2.98 ± 0.64. Using social media to seek sexual partners was associated with higher anticipated HIV stigma (Adjusted β = 0.11, 95% confidence interval (CI): 0.05 to 0.17, p = 0.001). HIV self-testing (Adjusted β = - 0.07, 95%CI: - 0.13 to - 0.01, p = 0.02) and having disclosed one's sexual orientation to a healthcare provider (Adjusted β = - 0.16, 95%CI: - 0.22 to - 0.96, p < 0.001) were associated with lower anticipated HIV stigma.
CONCLUSION
Our data suggested that anticipated HIV stigma is still common among Chinese MSM not living with HIV. Tailored anti-HIV stigma campaigns on social media are especially needed, and the promotion of HIVST may be a promising approach.",2020,"Using social media to seek sexual partners was associated with higher anticipated HIV stigma (Adjusted β = 0.11, 95% confidence interval (CI): 0.05 to 0.17, p = 0.001).","['HIV negative men who have sex with men in China', 'Most men completed high school (1308/2006, 65.2%) and had an annual personal income of ≤9200 USD ', '2006 men completed the survey', 'Chinese men who have sex with men (MSM', '16\u2009years old and self-reported as HIV negative or unknown, were recruited from a gay mobile phone application in China']",[],"['HIV stigma', 'socio-demographics, sexual behaviors, sexual health service utilization, and anticipated HIV stigma', 'mean anticipated HIV stigma score', 'HIV stigma scores']","[{'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557168', 'cui_str': 'Individual income'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0380416,"Using social media to seek sexual partners was associated with higher anticipated HIV stigma (Adjusted β = 0.11, 95% confidence interval (CI): 0.05 to 0.17, p = 0.001).","[{'ForeName': 'Chuncheng', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Pan', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Bolin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Ong', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Fu', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Chongyi', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Dermatology Hospital of Southern Medical University and the University of North Carolina Project-China, No.2 Lujing Road, Guangzhou, 510095, China. weimingtangscience@gmail.com.'}]",BMC infectious diseases,['10.1186/s12879-020-4778-5']
305,31674644,Effect of Abaloparatide vs Alendronate on Fracture Risk Reduction in Postmenopausal Women With Osteoporosis.,"CONTEXT
The ACTIVE study demonstrated the antifracture efficacy of abaloparatide in postmenopausal women with osteoporosis. ACTIVExtend demonstrated sustained fracture risk reduction with alendronate in abaloparatide-treated participants from ACTIVE. A direct comparison of the efficacy of abaloparatide and antiresorptive therapies has not been performed.
OBJECTIVE
The objective of this analysis is to compare the antifracture efficacy of abaloparatide in ACTIVE with that of alendronate in ACTIVExtend.
DESIGN
In this post hoc analysis, the rate of new vertebral fractures for women in ACTIVExtend (N = 1139) was calculated based on baseline and endpoint radiographs for placebo or abaloparatide in ACTIVE and alendronate in ACTIVExtend. Vertebral fracture rates between abaloparatide and alendronate were compared in a Poisson regression model. Fracture rates for nonvertebral and clinical fractures were compared based on a Poisson model during 18 months of abaloparatide or placebo treatment in ACTIVE and 18 months of alendronate treatment in ACTIVExtend.
RESULTS
The vertebral fracture rate was lower during abaloparatide treatment in ACTIVE (0.47 fractures/100 patient-years) than alendronate treatment in ACTIVExtend (1.66 fractures/100 patient-years) (relative risk reduction 71%; P = .027). Although the comparisons did not meet statistical significance, after switching from placebo (ACTIVE) to alendronate (ACTIVExtend), the rate of new vertebral fractures decreased from 2.49 to 1.66 fractures per 100 patient-years, and after switching from abaloparatide to alendronate from 0.47 to 0.19 fractures per 100 patient-years. The rates of nonvertebral fractures and clinical fractures were not significantly different.
CONCLUSION
Initial treatment with abaloparatide may result in greater vertebral fracture reduction compared with alendronate in postmenopausal women with osteoporosis.",2020,The vertebral fracture rate was lower during abaloparatide treatment in ACTIVE (0.47 fractures/100 patient-years) than alendronate treatment in ACTIVExtend (1.66 fractures/100 patient-years) (relative risk reduction [RRR] 71%; P=0.027).,"['Postmenopausal Women With Osteoporosis', 'postmenopausal women with osteoporosis']","['abaloparatide', 'abaloparatide and alendronate', 'Abaloparatide Versus Alendronate', 'placebo', 'alendronate', 'abaloparatide and antiresorptive therapies']","['rate of nonvertebral fractures and clinical fractures', 'rate of new vertebral fractures', 'vertebral fracture rate', 'sustained fracture risk reduction', 'Fracture rates', 'Vertebral fracture rates', 'vertebral fracture reduction', 'Fracture Risk Reduction']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0384939,The vertebral fracture rate was lower during abaloparatide treatment in ACTIVE (0.47 fractures/100 patient-years) than alendronate treatment in ACTIVExtend (1.66 fractures/100 patient-years) (relative risk reduction [RRR] 71%; P=0.027).,"[{'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Leder', 'Affiliation': 'Endocrinology Unit, Massachusetts General Hospital and Department of Medicine, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Mitlak', 'Affiliation': 'Radius Health, Inc, Waltham, MA, USA.'}, {'ForeName': 'Ming-Yi', 'Initials': 'MY', 'LastName': 'Hu', 'Affiliation': 'Radius Health, Inc, Waltham, MA, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Hattersley', 'Affiliation': 'Radius Health, Inc, Waltham, MA, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Bockman', 'Affiliation': 'Joan and Sanford Weill Medical College of Cornell University, Hospital for Special Surgery, New York, NY, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz162']
306,32265255,"Comparing the efficacy and safety of insulin detemir versus neutral protamine hagedorn insulin in treatment of diabetes during pregnancy: a randomized, controlled study.","OBJECTIVE
To compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) insulin used in pregnant women with diabetes.
RESEARCH DESIGN AND METHODS
A randomized study was conducted in diabetic pregnant women (n=240) (including 132 with pregestational diabetes and 108 with gestational diabetes). All patients were randomly divided into two groups: IDet group (n=120) treated with IDet plus short acting insulin Novolin-R before three meals (RRR-IDet plan), and NPH group treated with NPH plus Novolin-R before three meals (RRR-NPH plan). Patients were enrolled during 12-28 gestation weeks and followed up until delivery.
RESULTS
Basal characteristics, such as age, enrollment gestational weeks, average HbA1c, fasting plasma glucose (FPG) and oral glucose tolerance test (OGTT) were similar between two groups. After 1 week of treatment, the FPG of IDet group were significantly lower than NPH group (p<0.05) and the time required to reach the targeted blood glucose level was significantly shorter (p<0.001). After 3 months of treatment, the HbA1c level in the two groups was normalized but there was no significant difference in HbA1c level. Maternal and neonatal outcomes were comparable between the two therapeutic approaches; however, the incidence of hypoglycemia in IDet group was remarkably lower than that of NPH group (p<0.05). The adverse drug reactions were rare and similar between the two groups.
CONCLUSIONS
For the treatment of gestational diabetes, both RRR-IDet plan and RRR-NPH plan were reported to control blood glucose effectively. Compared with NPH, IDet could control blood glucose and reached the targets faster and more effectively, thus reducing the number of insulin injections and the incidence of hypoglycemia in pregnant women without increasing adverse birth outcomes. Therefore, for pregnant women with gestational diabetes, who require insulin therapy, IDet would be an ideal basal insulin being worthy of promotion in clinical settings.",2020,"After 3 months of treatment, the HbA1c level in the two groups was normalized but there was no significant difference in HbA1c level.","['diabetic pregnant women (n=240) (including 132 with pregestational diabetes and 108 with gestational diabetes', 'pregnant women with diabetes', 'pregnant women', 'diabetes during pregnancy', 'pregnant women with gestational diabetes']","['NPH', 'insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) insulin', 'insulin detemir versus neutral protamine hagedorn insulin', 'IDet group (n=120) treated with IDet plus short acting insulin Novolin-R before three meals (RRR-IDet plan), and NPH group treated with NPH plus Novolin-R before three meals (RRR-NPH plan']","['adverse drug reactions', 'HbA1c level', 'number of insulin injections and the incidence of hypoglycemia', 'time required to reach the targeted blood glucose level', 'average HbA1c, fasting plasma glucose (FPG) and oral glucose tolerance test (OGTT', 'incidence of hypoglycemia', 'control blood glucose', 'Maternal and neonatal outcomes']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0020258', 'cui_str': 'Normal pressure hydrocephalus'}, {'cui': 'C0537270', 'cui_str': 'insulin detemir'}, {'cui': 'C0021658', 'cui_str': 'insulin, isophane'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0356365', 'cui_str': 'Short-acting insulin'}, {'cui': 'C0307073', 'cui_str': 'Novolin R'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0281521,"After 3 months of treatment, the HbA1c level in the two groups was normalized but there was no significant difference in HbA1c level.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ji', 'Affiliation': ""Department of Obstetrics and Gynecology, Northwest Women's and Children's Hospital, Xi'an, China.""}, {'ForeName': 'Zhangya', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ""Department of Nutrition and Food Safety, School of Public Health, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Obstetrics and Gynecology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Mi', 'Affiliation': ""Department of Obstetrics and Gynecology, Northwest Women's and Children's Hospital, Xi'an, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Guo', 'Affiliation': ""Department of Obstetrics and Gynecology, Northwest Women's and Children's Hospital, Xi'an, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': ""Department of Obstetrics and Gynecology, Northwest Women's and Children's Hospital, Xi'an, China.""}, {'ForeName': 'Jiayi', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': ""Department of Nutrition and Food Safety, School of Public Health, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Zhengfeei', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': ""Department of Health and Environmental Sciences, Xi'an Jiaotong-Liverpool University, Suzhou, China.""}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': ""Department of Nutrition and Food Safety, School of Public Health, Xi'an Jiaotong University, Xi'an, China luoxiaoqin2012@mail.xjtu.edu.cn hanzhen@xjtufh.edu.cn.""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': ""Department of Obstetrics and Gynecology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China luoxiaoqin2012@mail.xjtu.edu.cn hanzhen@xjtufh.edu.cn.""}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-001155']
307,32265500,Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study.,"Early molecular response is associated with improved probability of deep molecular response and superior survival in patients with CML-CP. However, ~1 in 3 patients on first-line imatinib do not achieve this threshold. The phase 2b DASCERN trial (NCT01593254) assessed the outcome of early switch to dasatinib in patients with suboptimal response to first-line imatinib. Adult patients with CML-CP were randomized (2:1) to receive 100 mg dasatinib (n = 174) or continue imatinib at ≥400 mg (n = 86). The primary endpoint was the rate of major molecular response (MMR) at 12 months, which was 29% (dasatinib) and 13% (imatinib; P = 0.005). After ≥2 years of follow-up, 45 patients (52%) randomized to continue imatinib had crossed over to dasatinib. Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat). Adverse events were consistent with the established safety profiles of both drugs. The results of this first prospective study support early monitoring of patients treated with first-line imatinib, and suggest that switching to dasatinib in cases of suboptimal response may offer clinical benefit. Further follow-up is needed to assess the long-term clinical benefit of early switching.",2020,"Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat).","['patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy', 'patients with CML-CP', 'Adult patients with CML-CP', 'patients with suboptimal response to first-line imatinib']","['Dasatinib vs. imatinib', '100\u2009mg dasatinib (n\u2009=\u2009174) or continue imatinib']","['probability of deep molecular response and superior survival', '2-year cumulative MMR rate', 'Adverse events', 'rate of major molecular response (MMR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.0336482,"Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat).","[{'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Georgia Cancer Center, Augusta University, Augusta, GA, USA. jorge.cortes@augusta.edu.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jianxiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Jianyu', 'Initials': 'J', 'LastName': 'Weng', 'Affiliation': ""Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Huanling', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hochhaus', 'Affiliation': 'Universitätsklinikum Jena, Jena, Germany.'}, {'ForeName': 'Dong-Wook', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Jerald', 'Initials': 'J', 'LastName': 'Radich', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Savona', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Martin-Regueira', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Oumar', 'Initials': 'O', 'LastName': 'Sy', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Renuka', 'Initials': 'R', 'LastName': 'Gurnani', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Saglio', 'Affiliation': 'University of Turin, Turin, Italy.'}]",Leukemia,['10.1038/s41375-020-0805-1']
308,32266457,"A phase I study investigation of metabolism, and disposition of [ 14 C]-anlotinib after an oral administration in patients with advanced refractory solid tumors.","PURPOSE
Anlotinib is a novel oral multi-targeted receptor tyrosine kinase inhibitor, which selectively inhibits VEGFR2/3, FGFR1-4, PDGFR α/β, c-kit, and Ret. It shows antitumor effect in patients with advanced refractory solid tumors. The detailed absorption, metabolism, and excretion pathways of anlotinib have not yet been fully investigated.
METHODS
Six male patients were enrolled and divided into two groups. Group A (containing two patients) received 14.15 mg/80 µCi/subject [ 14 C]-anlotinib hydrochloride. Group B (containing four patients) received 14.15 mg/120 µCi/subject [ 14 C]-anlotinib hydrochloride. The blood, urine, and feces of all the six patients after orally administration of [ 14 C]-anlotinib were collected. The absorption, metabolism, and excretion of [ 14 C]-anlotinib were investigated, and the efficacy and safety of anlotinib were evaluated.
RESULTS
In plasma, the average time to peak concentration (T max ) of total radioactivity was 4.42 h and the average peak concentration (C max ) of total radioactivity was 18.80 ng Eq./g. The average values of AUC 0-last , AUC 0-∞ , and MRT 0-t were 4071 h.ng Eq./g, 13,555 h.ng Eq./g, and 125 h, respectively. The average recovery of total radioactivity (TRA) in urine and feces was 62.03%, accounting for 48.52% and 13.51% in feces and urine of the total dosage, respectively. The parent drug, a carboxylic metabolite (M30), and mono-oxidation products (M46/M66) were major drug-related components in human plasma. Oxidative metabolism played the major role in drug clearance in human. The major metabolic pathways include oxidative deamination to M2, mono-oxidation to M1, and the formation of M30. Adverse events occurred in five patients and severe adverse events (SAE) occurred in one. Tumor response were evaluated as stable disease (SD) in three, partial response (PR) in one, and progressive disease (PD) in one of the patients, respectively.
CONCLUSIONS
Anlotinib had a good pharmacokinetic profile with rapid absorption, long half-life, and extensive hepatic metabolism. The adverse events and efficacy were as expected.",2020,"In plasma, the average time to peak concentration (T max ) of total radioactivity was 4.42 h and the average peak concentration (C max ) of total radioactivity was 18.80 ng Eq./g.","['Six male patients', 'patients with advanced refractory solid tumors', 'human']","['14.15\xa0mg/80\xa0µCi/subject [ 14 C]-anlotinib hydrochloride', 'hydrochloride']","['absorption, metabolism, and excretion of [ 14 C]-anlotinib', 'efficacy and safety of anlotinib', 'average time to peak concentration (T max ) of total radioactivity', 'severe adverse events (SAE', 'Tumor response', 'partial response (PR) in one, and progressive disease (PD', 'average peak concentration (C max ) of total radioactivity', 'average values of AUC 0-last , AUC 0-∞ , and MRT 0-t', 'average recovery of total radioactivity (TRA) in urine and feces', 'blood, urine, and feces', 'Adverse events', 'adverse events and efficacy']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0302945', 'cui_str': 'Carbon-14'}, {'cui': 'C4519250', 'cui_str': 'anlotinib'}]","[{'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0302945', 'cui_str': 'Carbon-14'}, {'cui': 'C4519250', 'cui_str': 'anlotinib'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034553', 'cui_str': 'Radioactivity'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0024943', 'cui_str': 'Mauritania'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",6.0,0.0303326,"In plasma, the average time to peak concentration (T max ) of total radioactivity was 4.42 h and the average peak concentration (C max ) of total radioactivity was 18.80 ng Eq./g.","[{'ForeName': 'Yiqian', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Oncology, First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Nanjing, Jiangsu, 210029, People's Republic of China.""}, {'ForeName': 'Lianke', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Oncology, First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Nanjing, Jiangsu, 210029, People's Republic of China.""}, {'ForeName': 'Lingxiang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Oncology, First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Nanjing, Jiangsu, 210029, People's Republic of China.""}, {'ForeName': 'Tongshan', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ""Department of Oncology, First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Nanjing, Jiangsu, 210029, People's Republic of China.""}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of DMPK Service, Lab Testing Division, WuXi AppTec Co. Ltd, Nanjing, 210038, China.'}, {'ForeName': 'Yixiang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of DMPK Service, Lab Testing Division, WuXi AppTec Co. Ltd, Nanjing, 210038, China.'}, {'ForeName': 'Zhengzhen', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Department of DMPK Service, Lab Testing Division, WuXi AppTec Co. Ltd, Nanjing, 210038, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': ""Department of Oncology, First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Nanjing, Jiangsu, 210029, People's Republic of China. shuyongqiantg@126.com.""}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04062-8']
309,32252101,Addition of Caffeine to a Carbohydrate Feeding Strategy Prior to Intermittent Exercise.,"The ergogenic effect of caffeine is well established, although no investigations providing a high carbohydrate feeding strategy (pre-exercise meal=2 g/kg BM) co-ingested with caffeine exist for soccer. This investigation examines the effect of caffeine in addition to a pre-exercise carbohydrate meal and drink mid-way through a soccer simulation. Eight recreational soccer players completed an 85-minute soccer simulation followed by an exercise capacity test (Yo-yo Intermittent Endurance test level 2) on two occasions. Prior to exercise participants consumed a high carbohydrate meal, with placebo or 5 mg/kg BM -1 caffeine. No significant performance effect was identified (p=0.099) despite a 12.8% (109 m) improvement in exercise capacity following caffeine. Rates of carbohydrate and fat oxidation did not differ between conditions and nor were differences apparent for plasma glucose, fatty acids, glycerol, β-hydroxybutyrate (p>0.05). However, an increase in lactate was observed for caffeine (p=0.039). A significant condition effect on rating of perceived exertion was identified (p<0.001), with the overall mean for the protocol lowered to 11.7±0.9 au for caffeine compared to 12.8±1.3 au. Caffeine supplementation with a carbohydrate feeding strategy failed to affect metabolic and metabolite responses, although reductions in perception of exercise were observed. While a 12.8% increase in exercise capacity was noted the findings were not significant, possibly due to the small sample size.",2020,"Rates of carbohydrate and fat oxidation did not differ between conditions and nor were differences apparent for plasma glucose, fatty acids, glycerol, β-hydroxybutyrate (p>0.05).",['Eight recreational soccer players'],"['Caffeine', 'caffeine', '85-minute soccer simulation followed by an exercise capacity test (Yo-yo Intermittent Endurance test level 2', 'Caffeine supplementation', 'high carbohydrate meal, with placebo or 5\u2009mg/kg BM -1 caffeine']","['metabolic and metabolite responses', 'plasma glucose, fatty acids, glycerol, β-hydroxybutyrate (p>0.05', 'Rates of carbohydrate and fat oxidation', 'perception of exercise', 'performance effect', 'exercise capacity', 'lactate', 'rating of perceived exertion']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",,0.0329557,"Rates of carbohydrate and fat oxidation did not differ between conditions and nor were differences apparent for plasma glucose, fatty acids, glycerol, β-hydroxybutyrate (p>0.05).","[{'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hulton', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, Guildford, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Kaio', 'Initials': 'K', 'LastName': 'Vitzel', 'Affiliation': 'School of Heath Science, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Dominic A', 'Initials': 'DA', 'LastName': 'Doran', 'Affiliation': 'Research Institute of Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Don P M', 'Initials': 'DPM', 'LastName': 'MacLaren', 'Affiliation': 'Research Institute of Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom of Great Britain and Northern Ireland.'}]",International journal of sports medicine,['10.1055/a-1121-7817']
310,30958508,Recurrent Stroke With Rivaroxaban Compared With Aspirin According to Predictors of Atrial Fibrillation: Secondary Analysis of the NAVIGATE ESUS Randomized Clinical Trial.,"Importance
The NAVIGATE ESUS randomized clinical trial found that 15 mg of rivaroxaban per day does not reduce stroke compared with aspirin in patients with embolic stroke of undetermined source (ESUS); however, it substantially reduces stroke risk in patients with atrial fibrillation (AF).
Objective
To analyze whether rivaroxaban is associated with a reduction of recurrent stroke among patients with ESUS who have an increased risk of AF.
Design, Setting, and Participants
Participants were stratified by predictors of AF, including left atrial diameter, frequency of premature atrial contractions, and HAVOC score, a validated scheme using clinical features. Treatment interactions with these predictors were assessed. Participants were enrolled between December 2014 and September 2017, and analysis began March 2018.
Intervention
Rivaroxaban treatment vs aspirin.
Main Outcomes and Measures
Risk of ischemic stroke.
Results
Among 7112 patients with a mean (SD) age of 67 (9.8) years, the mean (SD) HAVOC score was 2.6 (1.8), the mean (SD) left atrial diameter was 3.8 (1.4) cm (n = 4022), and the median (interquartile range) daily frequency of premature atrial contractions was 48 (13-222). Detection of AF during follow-up increased for each tertile of HAVOC score: 2.3% (score, 0-2), 3.0% (score, 3), and 5.8% (score, >3); however, neither tertiles of the HAVOC score nor premature atrial contractions frequency impacted the association of rivaroxaban with recurrent ischemic stroke (P for interaction = .67 and .96, respectively). Atrial fibrillation annual incidence increased for each tertile of left atrial diameter (2.0%, 3.6%, and 5.2%) and for each tertile of premature atrial contractions frequency (1.3%, 2.9%, and 7.0%). Among the predefined subgroup of patients with a left atrial diameter of more than 4.6 cm (9% of overall population), the risk of ischemic stroke was lower among the rivaroxaban group (1.7% per year) compared with the aspirin group (6.5% per year) (hazard ratio, 0.26; 95% CI, 0.07-0.94; P for interaction = .02).
Conclusions and Relevance
The HAVOC score, left atrial diameter, and premature atrial contraction frequency predicted subsequent clinical AF. Rivaroxaban was associated with a reduced risk of recurrent stroke among patients with ESUS and moderate or severe left atrial enlargement; however, this needs to be independently confirmed before influencing clinical practice.",2019,"Rivaroxaban was associated with a reduced risk of recurrent stroke among patients with ESUS and moderate or severe left atrial enlargement; however, this needs to be independently confirmed before influencing clinical practice.","['patients with atrial fibrillation (AF', 'patients with ESUS and moderate or severe left atrial enlargement', '7112 patients with a mean (SD) age of 67 (9.8) years, the mean (SD) HAVOC score was 2.6\u2009(1.8), the mean (SD) left atrial diameter was 3.8\u2009(1.4) cm (n\u2009=\u20094022), and the median (interquartile range) daily frequency of premature atrial contractions was 48 (13-222', 'patients with ESUS who have an increased risk of AF.\nDesign, Setting, and Participants\n\n\nParticipants', 'patients with embolic stroke of undetermined source (ESUS', 'Participants were enrolled between December 2014 and September 2017, and analysis began March 2018']","['aspirin', 'Rivaroxaban', 'Aspirin', 'rivaroxaban', 'Rivaroxaban treatment vs aspirin']","['Detection of AF', 'recurrent stroke', 'Atrial fibrillation annual incidence', 'premature atrial contractions frequency', 'risk of ischemic stroke', 'Measures\n\n\nRisk of ischemic stroke', 'HAVOC score nor premature atrial contractions frequency', 'HAVOC score, left atrial diameter, and premature atrial contraction frequency', 'stroke risk', 'recurrent ischemic stroke', 'left atrial diameter']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0741276'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0033036', 'cui_str': 'Premature Atrial Contractions'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0033036', 'cui_str': 'Premature Atrial Contractions'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}]",7112.0,0.0790898,"Rivaroxaban was associated with a reduced risk of recurrent stroke among patients with ESUS and moderate or severe left atrial enlargement; however, this needs to be independently confirmed before influencing clinical practice.","[{'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Division of Cardiology, Hamilton Health Sciences, Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Gladstone', 'Affiliation': 'Division of Neurology and Hurvitz Brain Sciences Program, Sunnybrook Health Sciences Centre and Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Balakumar', 'Initials': 'B', 'LastName': 'Swaminathan', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Eckstein', 'Affiliation': 'Department of Internal Medicine, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Epstein', 'Affiliation': 'Electrophysiology Section, Cardiovascular Division University of Pennsylvania, Cardiology Section, Philadelphia VA Medical Center, Philadelphia.'}, {'ForeName': 'Karl Georg', 'Initials': 'KG', 'LastName': 'Haeusler', 'Affiliation': 'Department of Neurology, Universitätsklinikum Würzburg, Würzburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mikulik', 'Affiliation': ""International Clinical Research Center and Neurology Department, St. Anne's University Hospital and Masaryk University, Brno, Czech Republic.""}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Toni', 'Affiliation': 'Department of Human Neurosciences, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Arauz', 'Affiliation': 'Instituto Nacional de Neurologia y Neurocirugia, Mexico D.F., Mexico City, Mexico.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Ntaios', 'Affiliation': 'Department of Medicine, University of Thesally, Larissa, Greece.'}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'UWA Medical School, University of Western Australia, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Kanjana', 'Initials': 'K', 'LastName': 'Perera', 'Affiliation': 'McMaster University/Population Health Research Institute, Department of Medicine (Neurology), Hamilton, Ontario, Canada.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Pagola', 'Affiliation': ""Unitat d'Ictus, Servei de Neurologia, Hospital Universitari Vall d'Hebrón, Barcelona, Spain.""}, {'ForeName': 'Ashfaq', 'Initials': 'A', 'LastName': 'Shuaib', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Lutsep', 'Affiliation': 'Department of Neurology, OHSU, VA Portland Health Care System, Portland, Oregon.'}, {'ForeName': 'Xiaomeng', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'International University of Health and Welfare, Sanno Hospital and Sanno Medical Center, Tokyo, Japan.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Klinik für Neurologie, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Shelagh B', 'Initials': 'SB', 'LastName': 'Coutts', 'Affiliation': 'Department of Clinical Neurosciences, Radiology, and Community Health Sciences, University of Calgary, Foothills Medical Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Karlinski', 'Affiliation': 'Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Czlonkowska', 'Affiliation': '2nd Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': 'Department of Pharmacology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Santo', 'Affiliation': 'Neurology Department, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer US LLC, Pharmaceuticals Clinical Development Thrombosis, Whippany, New Jersey.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Division of Cardiology, Hamilton Health Sciences, Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA neurology,['10.1001/jamaneurol.2019.0617']
311,32255395,Subacute effects of the psychedelic ayahuasca on the salience and default mode networks.,"BACKGROUND
Neuroimaging studies have just begun to explore the acute effects of psychedelics on large-scale brain networks' functional organization. Even less is known about the neural correlates of subacute effects taking place days after the psychedelic experience. This study explores the subacute changes of primary sensory brain networks and networks supporting higher-order affective and self-referential functions 24 hours after a single session with the psychedelic ayahuasca.
METHODS
We leveraged task-free functional magnetic resonance imaging data 1 day before and 1 day after a randomized placebo-controlled trial exploring the effects of ayahuasca in naïve healthy participants (21 placebo/22 ayahuasca). We derived intra- and inter-network functional connectivity of the salience, default mode, visual, and sensorimotor networks, and assessed post-session connectivity changes between the ayahuasca and placebo groups. Connectivity changes were associated with Hallucinogen Rating Scale scores assessed during the acute effects.
RESULTS
Our findings revealed increased anterior cingulate cortex connectivity within the salience network, decreased posterior cingulate cortex connectivity within the default mode network, and increased connectivity between the salience and default mode networks 1 day after the session in the ayahuasca group compared to placebo. Connectivity of primary sensory networks did not differ between groups. Salience network connectivity increases correlated with altered somesthesia scores, decreased default mode network connectivity correlated with altered volition scores, and increased salience default mode network connectivity correlated with altered affect scores.
CONCLUSION
These findings provide preliminary evidence for subacute functional changes induced by the psychedelic ayahuasca on higher-order cognitive brain networks that support interoceptive, affective, and self-referential functions.",2020,"Salience network connectivity increases correlated with altered somesthesia scores, decreased default mode network connectivity correlated with altered volition scores, and increased salience default mode network connectivity correlated with altered affect scores.
",['naïve healthy participants (21 placebo/22 ayahuasca'],"['ayahuasca', 'psychedelic ayahuasca', 'placebo']","['anterior cingulate cortex connectivity', 'Hallucinogen Rating Scale scores', 'altered somesthesia scores', 'posterior cingulate cortex connectivity', 'salience default mode network connectivity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0330913', 'cui_str': 'Banisteriopsis'}]","[{'cui': 'C0330913', 'cui_str': 'Banisteriopsis'}, {'cui': 'C0018533', 'cui_str': 'Hallucinogen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0018533', 'cui_str': 'Hallucinogen'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234209', 'cui_str': 'Somatic sensation'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",,0.144697,"Salience network connectivity increases correlated with altered somesthesia scores, decreased default mode network connectivity correlated with altered volition scores, and increased salience default mode network connectivity correlated with altered affect scores.
","[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Pasquini', 'Affiliation': 'Memory and Aging Center, University of California, San Francisco, United States of America.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Palhano-Fontes', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte, Natal-RN, Brazil.'}, {'ForeName': 'Draulio B', 'Initials': 'DB', 'LastName': 'Araujo', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte, Natal-RN, Brazil.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120909409']
312,32049772,Clinic-Based Pediatric Disclosure Intervention Trial Improves Pediatric HIV Status Disclosure in Ghana.,"BACKGROUND
Disclosing HIV status to HIV-positive children is a major challenge facing families and health care providers. Despite recommendations for disclosure, rates remain low. We tested whether a pediatric HIV disclosure intervention delivered as an integral component of routine HIV health care in Ghana would improve disclosure to children.
METHODS
Dyads of HIV-infected children aged 7-18 years and their caregivers were enrolled from 2 HIV clinics in Accra and Kumasi, Ghana. The sites were randomly assigned to one of the 2 intervention arms to avoid treatment contamination between intervention and control participants. Trained interventionist used theory-guided therapeutic communication and personalized interaction to promote disclosure. Disclosure outcomes were measured at 12-week intervals. All analyses were completed using a modified intention-to-treat approach.
RESULTS
We enrolled 446 child-caregiver dyads (N = 240 intervention group; N = 206 control group); 52% of the children were boys, mean age 9.78 (±2.27) years. For disclosure at 1 year, a better overall treatment effect was observed (P < 0.001). Children in the treatment group had greater disclosure at each time point (P < 0.001) and a higher proportion of them had been disclosed to by 1 year (51.4% vs. 16.2%; P < 0.001; un-adjusted hazard ratio = 3.98: 95% confidence interval: 2.63 to 6.03) and 3 years (71.3% vs. 34.0%; unadjusted hazard ratio = 4.21: 95% confidence interval: 3.09 to 5.72). In the multivariate Cox model, factors associated with disclosure were treatment group (P < 0.001), children <11 years of age (P < 0.001), HIV-infected caregivers (P = 0.015), and caregiver's with greater education (P = 0.022).
CONCLUSIONS
This practical clinic-based disclosure intervention shows excellent promise as a means of improving HIV pediatric disclosure outcomes.",2020,"Children in the treatment group had greater disclosure at each time point (p<0.001) and a higher proportion of them had been disclosed to by 1 year (51.4% vs 16.2%; p<0.001; un-adjusted HR=3.98: 95% CI, 2.63, 6.03) and 3 years (71.3% vs 34.0%; unadjusted HR=4.21: 95% CI, 3.09, 5.72).","['Dyads of HIV-infected children aged 7 to 18 years and their caregivers were enrolled from two HIV clinics in Accra and Kumasi, Ghana', 'We enrolled 446 child-caregiver dyads (N=240 intervention group; N=206 control group); 52% of the children were male, mean age 9.78 (±2.27) years', 'Pediatric HIV Status Disclosure in Ghana']",['pediatric HIV disclosure intervention'],"['greater disclosure', 'Disclosure outcomes']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]",446.0,0.205796,"Children in the treatment group had greater disclosure at each time point (p<0.001) and a higher proportion of them had been disclosed to by 1 year (51.4% vs 16.2%; p<0.001; un-adjusted HR=3.98: 95% CI, 2.63, 6.03) and 3 years (71.3% vs 34.0%; unadjusted HR=4.21: 95% CI, 3.09, 5.72).","[{'ForeName': 'Elijah', 'Initials': 'E', 'LastName': 'Paintsil', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Tassos C', 'Initials': 'TC', 'LastName': 'Kyriakides', 'Affiliation': 'Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, CT.'}, {'ForeName': 'Sampson', 'Initials': 'S', 'LastName': 'Antwi', 'Affiliation': 'Department of Child Health, School of Medical Sciences, Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital, Kumasi, Ghana.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Renner', 'Affiliation': 'Department of Child Health, University of Ghana School of Medicine and Dentistry and Korle-Bu Teaching Hospital, Accra, Ghana.'}, {'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'Nichols', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Kofi', 'Initials': 'K', 'LastName': 'Amissah', 'Affiliation': 'Department of Child Health, School of Medical Sciences, Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital, Kumasi, Ghana.'}, {'ForeName': 'Jonas T', 'Initials': 'JT', 'LastName': 'Kusah', 'Affiliation': 'Department of Child Health, University of Ghana School of Medicine and Dentistry and Korle-Bu Teaching Hospital, Accra, Ghana.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Alhassan', 'Affiliation': 'Department of Child Health, School of Medical Sciences, Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital, Kumasi, Ghana.'}, {'ForeName': 'Irene P', 'Initials': 'IP', 'LastName': 'Ofori', 'Affiliation': 'Department of Child Health, School of Medical Sciences, Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital, Kumasi, Ghana.'}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Catlin', 'Affiliation': 'Department of Research Computing, Rosen Center for Advanced Computing, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Geliang', 'Initials': 'G', 'LastName': 'Gan', 'Affiliation': 'Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, CT.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Lartey', 'Affiliation': 'Department of Medicine, University of Ghana School of Medicine and Dentistry and Korle-Bu Teaching Hospital, Accra, Ghana.'}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Reynolds', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002316']
313,32203986,Cecal intubation time between the use of one-channel and two-channel water exchange colonoscopy: A randomized controlled trial.,"BACKGROUND AND AIM
Water exchange (WE) colonoscopy is the least painful insertion technique with high adenoma detection rate but requires a longer intubation time. In the published literature, some investigators used the instrument channel for both infusing and suctioning of water (one channel), while others use colonoscopes with an integrated water-jet channel specifically designed for infusing water (two channel). The aim of this study was to compare cecal intubation time between one-channel and two-channel WE.
METHODS
A total 120 patients undergoing colonoscopy from May 2017 to April 2019 at a regional hospital in southern Taiwan were randomized to either a two-channel group (n = 60) or a one-channel group (n = 60). The primary outcome was cecal intubation time.
RESULTS
The mean cecal intubation time was significantly shorter in the two-channel group compared with the one-channel group (14.0 ± 4.0 vs 17.4 ± 6.7 min, P < 0.001). The two-channel group required less water infused during insertion (564.8 ± 232.4 vs 1213.3 ± 467.5 mL, P < 0.001) but achieved a significantly higher Boston Bowel Preparation Scale score (8.4 ± 0.8 vs 7.5 ± 1.1, P < 0.001) than did the one-channel group. The adenoma detection rate was comparable in the two groups (50.0% vs 48.3%, P = 0.855).
CONCLUSIONS
In comparison with the one-channel WE, two-channel WE showed a shorter cecal intubation time, required less amount of water during insertion, and provided a better salvage cleansing effect. (NCT03279705).",2020,"The mean cecal intubation time was significantly shorter in the two-channel group compared with the one-channel group (14.0 ± 4.0 min vs. 17.4 ± 6.7 min, P < 0.001).",['A total 120 patients undergoing colonoscopy from May 2017 to April 2019 at a regional hospital in southern Taiwan'],"['One- and Two-Channel Water Exchange Colonoscopy', 'channel group (n=60) or a one-channel group']","['shorter cecal intubation time', 'Cecal Intubation Time', 'mean cecal intubation time', 'cecal intubation time', 'higher Boston Bowel Preparation Scale score', 'ADR']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}]","[{'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}]",120.0,0.0829449,"The mean cecal intubation time was significantly shorter in the two-channel group compared with the one-channel group (14.0 ± 4.0 min vs. 17.4 ± 6.7 min, P < 0.001).","[{'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Tseng', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Koo', 'Affiliation': 'Graduate Institute of Long-term Care, Tzu Chi University of Science and Technology, Hualien City, Hualien, Taiwan.'}, {'ForeName': 'Yu-Hsi', 'Initials': 'YH', 'LastName': 'Hsieh', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15043']
314,31454829,Acute kidney injury risk-based screening in pediatric inpatients: a pragmatic randomized trial.,"BACKGROUND
Pediatric acute kidney injury (AKI) is common and associated with increased morbidity, mortality, and length of stay. We performed a pragmatic randomized trial testing the hypothesis that AKI risk alerts increase AKI screening.
METHODS
All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included. The intervention alert displayed if calculated AKI risk was > 50% and no serum creatinine (SCr) was ordered within 24 h. The primary outcome was SCr testing within 48 h of AKI risk > 50%.
RESULTS
Among intensive care admissions, 973/1909 (51%) were randomized to the intervention. Among those at risk, more SCr tests were ordered for the intervention group than for controls (418/606, 69% vs. 361/597, 60%, p = 0.002). AKI incidence and severity were the same in intervention and control groups. Among ward admissions, 5492/10997 (50%) were randomized to the intervention, and there were no differences between groups in SCr testing, AKI incidence, or severity of AKI.
CONCLUSIONS
Alerts based on real-time prediction of AKI risk increased screening rates in intensive care but not pediatric ward settings. Pragmatic clinical trials provide the opportunity to assess clinical decision support and potentially eliminate ineffective alerts.",2020,AKI incidence and severity were the same in intervention and control groups.,"['pediatric inpatients', 'All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included']",[],"['serum creatinine (SCr', 'SCr tests', 'AKI incidence and severity', 'morbidity, mortality, and length of stay', 'SCr testing within 48\u2009h of AKI risk', 'SCr testing, AKI incidence, or severity of AKI', 'calculated AKI risk']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0085559'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.192399,AKI incidence and severity were the same in intervention and control groups.,"[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA. sara.van.driest@vumc.org.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'McLemore', 'Affiliation': 'Health Information Technology, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Bridges', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Fleming', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'McGregor', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Jones', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Shirey-Rice', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Gatto', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Gay', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Bernard', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}]",Pediatric research,['10.1038/s41390-019-0550-1']
315,32144974,Long-term effects of intra-articular oxygen-ozone therapy versus hyaluronic acid in older people affected by knee osteoarthritis: A randomized single-blind extension study.,"BACKGROUND
There is little evidence on intra-articular (IA) treatment in knee osteoarthritis (KOA) and there is a lack of long-term follow-up studies.
OBJECTIVE
To assess the long-term effectiveness and safety of IA oxygen-ozone (O2O3) and hyaluronic acid (HA) in terms of functioning in KOA patients over a 31-week period.
METHODS
Patients aged ⩾ 60 years with KOA were randomly allocated to receive 4 IA knee injections (1/week) of O2O3 or HA (T0-T3) and a follow-up visit 4 weeks after the fourth injection (T4). In this extension study we assessed VAS and safety in patients with Visual Analogue Scale (VAS) ⩾ 4 at the at 6-month follow-up visit (T5), undergoing a second treatment cycle (T5-T8) and 1-month follow-up visit (T9).
RESULTS
Forty-two patients (aged 70.5 ± 5.8 years) were randomly allocated to O2O3 (n= 22) or HA group (n= 20). Twenty-three underwent another IA cycle: 12 (54.6%) in the O2O3 group and 11 (55.0%) in the HA group. Both groups showed significant reduction in VAS (p< 0.013) compared to baseline during both cycles. At follow-up visits (T4 and T9), VAS was significantly lower in the HA group (p< 0.013). There were no differences in adverse events occurrence between groups.
CONCLUSIONS
IA O2O3 might be comparable to HA in terms of effectiveness and safety in reducing pain in KOA patients, although at both follow-up visits (T4 and T9) VAS was significantly lower in the HA group.",2020,"At follow-up visits (T4 and T9), VAS was significantly lower in the HA group (p< 0.013).","['Patients aged ⩾ 60 years with KOA', 'older people affected by knee osteoarthritis', 'Forty-two patients (aged 70.5 ± 5.8 years', 'KOA patients over a 31-week period', 'patients with Visual Analogue Scale (VAS) ⩾ 4 at the at 6-month follow-up visit (T5), undergoing a second treatment cycle (T5-T8) and 1-month follow-up visit (T9']","['intra-articular oxygen-ozone therapy versus hyaluronic acid', '4 IA knee injections (1/week) of O2O3 or HA (T0-T3', 'IA oxygen-ozone (O2O3) and hyaluronic acid (HA']","['VAS', 'VAS and safety', 'adverse events occurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0537561', 'cui_str': '4-iodoacridine, I125-labeled'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",,0.0870579,"At follow-up visits (T4 and T9), VAS was significantly lower in the HA group (p< 0.013).","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'de Sire', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"", Novara, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Stagno', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"", Novara, Italy.'}, {'ForeName': 'Marco Alessandro', 'Initials': 'MA', 'LastName': 'Minetto', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cisari', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"", Novara, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Baricich', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"", Novara, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Invernizzi', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"", Novara, Italy.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181294']
316,31277077,Cardiorespiratory behavior of preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation: randomized crossover study.,"BACKGROUND
Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC) are modes of non-invasive respiratory support commonly used after extubation in extremely preterm infants. However, the cardiorespiratory physiology of these infants on each mode is unknown.
METHODS
Prospective, randomized crossover study in infants with birth weight ≤1250 g undergoing their first extubation attempt. NCPAP and HFNC were applied randomly for 45 min each, while ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ) were recorded. Respiratory signals were analyzed using an automated method, and differences between NCPAP and HFNC features and changes in FiO 2 were analyzed.
RESULTS
A total of 30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930 g [780, 1090] were studied. Infants were extubated at 5 days [2, 13] of life with 973 g [880, 1170] and three failed (10%). No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2 levels (p = 0.02) during HFNC compared to NCPAP.
CONCLUSIONS
In extremely preterm infants studied shortly after extubation, the use of HFNC was associated with longer respiratory pauses and higher FiO 2 requirements.",2020,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2 levels (p = 0.02) during HFNC compared to NCPAP.
","['extremely preterm infants', 'infants with birth weight ≤1250', 'preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation', '30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930\u2009g [780, 1090']","['HFNC', 'NCPAP and HFNC', 'Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC']","['longer respiratory pauses', 'ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ', 'cardiorespiratory behavior']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0222762', 'cui_str': 'Thoracic Cage'}, {'cui': 'C1286159', 'cui_str': 'Movement of abdomen'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",30.0,0.118465,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2 levels (p = 0.02) during HFNC compared to NCPAP.
","[{'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'Kanbar', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Shalish', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Latremouille', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kearney', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': ""Sant'Anna"", 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada. guilherme.santanna@mcgill.ca.'}]",Pediatric research,['10.1038/s41390-019-0494-5']
317,31494254,"Probiotics for intestinal decolonization of ESBL-producing Enterobacteriaceae: a randomized, placebo-controlled clinical trial.","OBJECTIVES
Infections with extended spectrum β-lactamase (ESBL)-producing Enterobacteriaceae (EPE) are a major healthcare concern. Our goal was to investigate whether a probiotic mixture could be used for eradication therapy in patients with prolonged intestinal EPE carriage.
METHODS
We performed a randomized, placebo-controlled, single-blinded clinical superiority trial in the south of Sweden between February 2017 and April 2019. Probiotic Vivomixx®, a mixture of 8 different living bacterial strains or placebo was given to adult outpatients intestinally colonized for at least 3 months with EPE. Patients with suspected active infections at the time of evaluation were excluded, and also those with immunosuppression, severe psychiatric disorder, drug abuse or dementia. Each patient in the probiotic arm was administered 2 sachets (9.0 × 10 11 live bacteria) twice daily for 2 months. The primary outcome was intestinal EPE eradication at the end of the 1-year follow-up, as shown by 3 consecutive negative EPE rectal swabs during the follow-up year. The per protocol follow-up for all patients was 1, 3, 6 and 12 months after the initiation of the intervention. ClinicalTrials.gov Identifier: NCT03860415.
RESULTS
In total, the target size of 80 patients were included. The median age was 68 years in both groups. The number of females in the probiotics group was 23 (58%) and in the placebo group 28 (70%). At the end of the trial, 12.5% (5 out of 40) of the patients in the probiotic group had achieved successful eradication of EPE, as defined by the primary outcome, in the intention to treat analysis. In the placebo group, 5% (2 out of 40) of the patients had achieved successful eradication of EPE (odds ratio 2.71; 95% confidence interval (CI), 0.49-14.9; p 0.24).
CONCLUSIONS
Successful EPE eradication was observed in very few individuals. This trial did not support Vivomixx® as being superior to placebo for intestinal decolonization in adult patients with chronic colonization of EPE, but was limited in power.",2020,"In the placebo group, 5% (2 out of 40) of the patients had achieved successful eradication of EPE (odds ratio 2.71; 95% confidence interval (CI), 0.49-14.9; p 0.24).
","['80 patients were included', 'south of Sweden between February 2017 and April 2019', 'patients with prolonged intestinal EPE carriage', 'adult patients with chronic colonization of EPE', 'adult outpatients intestinally colonized for at least 3\xa0months with EPE', 'Patients with suspected active infections at the time of evaluation were excluded, and also those with immunosuppression, severe psychiatric disorder, drug abuse or dementia']","['probiotic mixture', 'placebo', 'ESBL)-producing Enterobacteriaceae (EPE', 'extended spectrum β-lactamase ', 'Probiotic Vivomixx®', 'Probiotics']","['intestinal EPE eradication', 'number of females', 'successful eradication of EPE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse (disorder)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1444096', 'cui_str': 'Extended spectrum beta-lactamase producing bacteria'}, {'cui': 'C0014346', 'cui_str': 'Coliform Bacilli'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",80.0,0.504011,"In the placebo group, 5% (2 out of 40) of the patients had achieved successful eradication of EPE (odds ratio 2.71; 95% confidence interval (CI), 0.49-14.9; p 0.24).
","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ljungquist', 'Affiliation': ""Clinical Microbiology and Clinical Infection Medicine, Department of Translational Medicine, Faculty of Medicine, Lund University, Malmö, Sweden; Department of Infectious Disease, Helsingborg's Hospital, Helsingborg, Region Skåne, Sweden. Electronic address: oskar.ljungquist@med.lu.se.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kampmann', 'Affiliation': 'Department of Medical Sciences, Clinical Microbiology, Uppsala University, Sweden; Department of Infectious Disease, SUS Lund, Region Skåne, Sweden.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Resman', 'Affiliation': 'Clinical Microbiology and Clinical Infection Medicine, Department of Translational Medicine, Faculty of Medicine, Lund University, Malmö, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Riesbeck', 'Affiliation': 'Clinical Microbiology and Clinical Infection Medicine, Department of Translational Medicine, Faculty of Medicine, Lund University, Malmö, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tham', 'Affiliation': 'Clinical Microbiology and Clinical Infection Medicine, Department of Translational Medicine, Faculty of Medicine, Lund University, Malmö, Sweden.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2019.08.019']
318,31634897,"Augmenting extinction learning with D-cycloserine reduces return of fear: a randomized, placebo-controlled fMRI study.","D-cycloserine (DCS), a partial NMDA-receptor agonist, seems to be a promising enhancer for exposure therapy in anxiety disorders. It has been tested successfully in animal models of fear extinction, where DCS enhanced extinction learning. Applied in clinical studies, results of DCS-augmented exposure therapy remain ambiguous, calling for a deeper understanding of the underlying mechanisms of DCS and its exact effect on extinction learning and return of fear (ROF) in humans. In the present study, we investigated the effect of DCS-augmented extinction learning on behavioral, psychophysiological, and neural indices of ROF during a 24-h delayed recall test. Thirty-seven participants entered a randomized, placebo-controlled, double-blind, 3-day fear conditioning and delayed extinction fMRI design. One hour before extinction training, participants received an oral dose of 50 mg of DCS or a placebo. Behavioral arousal ratings revealed a generalized ROF during extinction recall in the placebo but not DCS group. Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects. Our finding that DCS reduces ROF in arousal ratings and neural structures subserving defensive reactions support a role for NMDA receptors in extinction memory consolidation and encourage further translational research.",2020,"Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects.",['Thirty-seven participants'],"['placebo-controlled, double-blind, 3-day fear conditioning and delayed extinction fMRI design', 'DCS-augmented extinction learning', 'DCS', 'placebo', 'D-cycloserine (DCS']","['hippocampal recruitment', 'return of fear', 'behavioral, psychophysiological, and neural indices of ROF', 'extinction learning and return of fear (ROF', 'Behavioral arousal ratings', 'differential BOLD responses']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}]",37.0,0.340641,"Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ebrahimi', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany. claudia.ebrahimi@charite.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Gechter', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schlagenhauf', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Alfons O', 'Initials': 'AO', 'LastName': 'Hamm', 'Affiliation': 'Department of Biological and Clinical Psychology/Psychotherapy, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0552-z']
319,31655485,Angiotensin involvement in trauma processing-exploring candidate neurocognitive mechanisms of preventing post-traumatic stress symptoms.,"The angiotensin-II antagonist losartan is a promising candidate that has enhanced extinction in a post-traumatic stress disorder (PTSD) animal model and was related to reducing PTSD symptom development in humans. Here, we investigate the neurocognitive mechanisms underlying these results, testing the effect of losartan on data-driven and contextual processing of traumatic material, mechanisms proposed to be relevant for PTSD development. In a double-blind between-subject design, 40 healthy participants were randomised to a single oral dose of losartan (50 mg) or placebo, 1 h before being exposed to distressing films as a trauma analogue while heart rate (HR) was measured. Peritraumatic processing was investigated using blurry picture stimuli from the films, which transformed into clear images. Data-driven processing was measured by the level of blurriness at which contents were recognised. Contextual processing was measured as the amount of context information retrieved when describing the pictures' contents. Negative-matched control images were used to test perceptual processing of peripheral trauma-cues. Post-traumatic stress symptoms were assessed via self-report questionnaires after analogue trauma and an intrusion diary completed over 4 days following the experiment. Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures. During the films, the losartan group recorded lower HR and higher HR variability, reflecting lower autonomic stress responses. We discuss potential mechanisms of losartan in preventing PTSD symptomatology, including the role of reduced arousal and increased contextual processing during trauma exposure, as well as increased threat-safety differentiation when encountering peripheral trauma-cues in the aftermaths of traumatic events.",2020,"Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures.",['40 healthy participants'],"['placebo', 'losartan', 'placebo, losartan', 'angiotensin-II antagonist losartan']","['contextual processing and enhanced detail perception', 'Contextual processing', 'lower HR and higher HR variability, reflecting lower autonomic stress responses']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",40.0,0.0689031,"Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures.","[{'ForeName': 'Lorika', 'Initials': 'L', 'LastName': 'Shkreli', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marcella Lydia', 'Initials': 'ML', 'LastName': 'Woud', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Ramsbottom', 'Affiliation': 'Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Aleksandra Ewa', 'Initials': 'AE', 'LastName': 'Rupietta', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Gerd Thomas', 'Initials': 'GT', 'LastName': 'Waldhauser', 'Affiliation': 'Department of Neuropsychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kumsta', 'Affiliation': 'Genetic Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reinecke', 'Affiliation': 'Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, OX37JX, UK. andrea.reinecke@psych.ox.ac.uk.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0553-y']
320,32248637,Investigation of optimal dose of early intervention to prevent posttraumatic stress disorder: A multiarm randomized trial of one and three sessions of modified prolonged exposure.,"BACKGROUND
Posttraumatic stress disorder (PTSD) is linked to a specific event, providing the opportunity to intervene in the immediate aftermath of trauma to prevent the development of this disorder. A previous trial demonstrated that trauma survivors who received three sessions of modified prolonged exposure therapy demonstrated decreased PTSD and depression prospectively compared to assessment only. The present study investigated the optimal dosing of this early intervention to test one versus three sessions of exposure therapy in the immediate aftermath of trauma.
METHODS
Participants (n = 95) recruited from a Level 1 Trauma Center were randomly assigned in a 1.5:1.5:1 ratio in a parallel-group design to the three conditions: one-session exposure therapy, three-session exposure therapy, and assessment only. Follow-up assessments were conducted by study assessors blind to study condition.
RESULTS
Mixed-effects model results found no significant differences in PTSD or depression symptoms between the control condition and those who received one or three exposure therapy sessions across 1-12-month follow-up assessment. Results indicate that the intervention did not interfere with natural recovery. Receiver operating characteristic curve analyses on the screening measure used for study inclusion (Predicting PTSD Questionnaire; PPQ) in the larger sample from which the treatment sample was drawn (n = 481) found that the PPQ was a poor predictor of likely PTSD at all follow-up time points (Area under the curve's = 0.55-0.62).
CONCLUSIONS
This likely impacted study results as many participants demonstrated natural recovery. Recommendations for future early intervention research are reviewed, including strategies to identify more accurately those at risk for PTSD and oversampling more severe trauma types.",2020,"RESULTS
Mixed-effects model results found no significant differences in PTSD or depression symptoms between the control condition and those who received one or three exposure therapy sessions across 1-12-month follow-up assessment.","['trauma survivors', 'Participants (n\u2009=\u200995) recruited from a Level 1 Trauma Center', 'posttraumatic stress disorder', 'Posttraumatic stress disorder (PTSD']","['early intervention', 'session exposure therapy, three-session exposure therapy, and assessment only']","['PTSD or depression symptoms', 'PTSD and depression']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.012171,"RESULTS
Mixed-effects model results found no significant differences in PTSD or depression symptoms between the control condition and those who received one or three exposure therapy sessions across 1-12-month follow-up assessment.","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Maples-Keller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Loren M', 'Initials': 'LM', 'LastName': 'Post', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Price', 'Affiliation': 'Department of Psychological Science, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Goodnight', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Burton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Carly W', 'Initials': 'CW', 'LastName': 'Yasinski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Michopoulos', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Stevens', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hinrichs', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Alex O', 'Initials': 'AO', 'LastName': 'Rothbaum', 'Affiliation': 'Department of Psychological Sciences, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hudak', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Houry', 'Affiliation': 'Division of Injury Prevention, National Center for Injury Control and Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Jovanovic', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Ressler', 'Affiliation': 'Department of Psychiatry, Mclean Hospital, Harvard Medical School, Belmont, Massachusetts.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}]",Depression and anxiety,['10.1002/da.23015']
321,32250021,"A Single-Dose, Open-Label, Randomized, Two-Way Crossover Study in Healthy Japanese Participants to Evaluate the Bioequivalence and the Food Effect on the Pharmacokinetics of Daprodustat.","Daprodustat is a prolyl hydroxylase inhibitor that stimulates erythropoiesis in a manner similar to the natural response to hypoxia, whereby inhibition of hypoxia inducible factor (HIF) prolyl-4-hydroxylases by daprodustat ultimately results in increased levels of HIF-responsive genes. Daprodustat is under development as an emerging new class of agents for the treatment of anemia associated with chronic kidney disease (CKD). This was a single-center, single-dose, open-label, randomized, 2-way crossover study in healthy Japanese male participants consisting of 2 parts. The primary objective was to evaluate the bioequivalence (BE) between daprodustat tablet strengths (part 1) and to evaluate the food effect on the pharmacokinetics (PK) of daprodustat (part 2). A total of 64 healthy Japanese male participants were enrolled; 52 participants were included in part 1 and 12 in part 2. BE was demonstrated between the daprodustat 2-mg tablet and the daprodustat 4-mg tablet. A standard CKD meal did not have a large effect on the PK parameters of daprodustat after a single oral dose of daprodustat 4 mg. Administration of single oral doses of daprodustat 4 mg was generally well tolerated in the healthy Japanese participants, and no new safety signals were identified without regard to food.",2020,A standard CKD meal did not have a large effect on the PK parameters of daprodustat after a single oral dose of daprodustat 4 mg.,"['64 healthy Japanese male participants were enrolled; 52 participants were included in part 1 and 12 in part 2', 'healthy Japanese male participants consisting of 2 parts', 'Healthy Japanese Participants to Evaluate', 'healthy Japanese participants', 'anemia associated with chronic kidney disease (CKD']",[],"['bioequivalence (BE', 'BE', 'tolerated']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]",[],"[{'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}]",64.0,0.018347,A standard CKD meal did not have a large effect on the PK parameters of daprodustat after a single oral dose of daprodustat 4 mg.,"[{'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Clinical Pharmacology Office, Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan.'}, {'ForeName': 'Minori', 'Initials': 'M', 'LastName': 'Osamura', 'Affiliation': 'Clinical Pharmacology Office, Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Ogura', 'Affiliation': 'Clinical Pharmacology Office, Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Onoue', 'Affiliation': 'Biomedical Data Sciences Department, Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Wakamatsu', 'Affiliation': 'Pre-Clinical Development Department, Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan.'}, {'ForeName': 'Yotaro', 'Initials': 'Y', 'LastName': 'Numachi', 'Affiliation': 'Medicines Development, Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Caltabiano', 'Affiliation': 'Clinical Development, GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Mahar', 'Affiliation': 'Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.793']
322,31352467,Neural responses during extinction learning predict exposure therapy outcome in phobia: results from a randomized-controlled trial.,"Extinction learning is assumed to represent a core mechanism underlying exposure therapy. Empirical evaluations of this assumption, however, are largely lacking. The current study investigated whether neural activations and self-report outcomes during extinction learning and extinction recall could specifically predict exposure therapy response in specific phobia. In this double-blind randomized controlled trial, individuals with spider phobia (N = 45; female/male = 41/4) were on group basis randomly allocated to exposure therapy (n = 25; female/male = 24/1) or progressive muscle relaxation (PMR; n = 20; female/male = 17/3). Intervention effects were measured with the Fears of Spiders questionnaire. Participants also underwent a three-day fear conditioning, extinction learning, and extinction recall paradigm during functional magnetic resonance imaging at baseline. Extinction outcomes were self-reported fear and threat expectancy, and neural responses during conditioned stimulus processing and during extinction-related prediction errors (US omissions) in regions of interest (ventromedial prefrontal cortex (vmPFC) and nucleus accumbens). Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90). Exposure therapy response was specifically predicted by prediction-error related vmPFC activation during early extinction. There were also indications vmPFC activations during conditioned safety stimulus processing at early extinction predicted therapy outcome. Neural activations during extinction recall and self-report data did however not predict therapy outcome. These findings indicate that exposure therapy may rely on neural extinction learning processes. Prediction errors are thought to drive the extinction learning process, and prediction error-related vmPFC activation specifically predicted therapy outcome. The extent to which vmPFC processes safety signals may additionally be predictive of exposure therapy response, but the specificity is less clear.",2020,Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90).,"['specific phobia', 'n\u2009=\u200920; female/male\u2009=\u200917/3', 'individuals with spider phobia (N\u2009=\u200945; female/male\u2009=\u200941/4', 'phobia']","['exposure therapy (n\u2009=\u200925; female/male\u2009=\u200924/1) or progressive muscle relaxation (PMR', 'extinction learning and extinction recall', 'extinction learning']","['stronger symptom reductions', 'Fears of Spiders questionnaire', 'self-reported fear and threat expectancy, and neural responses during conditioned stimulus processing and during extinction-related prediction errors (US omissions) in regions of interest', 'Neural responses']","[{'cui': 'C0236801', 'cui_str': 'Phobia, Specific'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037913', 'cui_str': 'Spiders'}, {'cui': 'C0349231', 'cui_str': 'Phobias'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus, function (observable entity)'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",,0.103046,Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90).,"[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Lange', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands. i.lange@maastrichtuniversity.nl.'}, {'ForeName': 'Liesbet', 'Initials': 'L', 'LastName': 'Goossens', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Michielse', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jindra', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Vervliet', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Laboratory of Biological Psychology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Machteld', 'Initials': 'M', 'LastName': 'Marcelis', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Wichers', 'Affiliation': 'Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion Regulation (ICPE), University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'van Os', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'van Amelsvoort', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Schruers', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0467-8']
323,32248324,Effects of repeated oral doses of ketoconazole on a sequential ascending single oral dose of fedratinib in healthy subjects.,"PURPOSE
Fedratinib is an orally administered Janus kinase 2-selective inhibitor that is indicated for the treatment of adult patients with intermediate-2 or high-risk myelofibrosis in the United States. Fedratinib is metabolized by multiple cytochrome P450s (CYPs) in vitro, with the predominant contribution from CYP3A4. The primary objective of this study was to evaluate the effects of 14-day repeated 200 mg twice daily (BID) oral doses of a strong CYP3A4 inhibitor, ketoconazole, on a sequential ascending single oral dose of fedratinib in healthy male subjects.
METHODS
An open-label, fixed-sequence, two-treatment cross-over study was conducted. Two cohorts of healthy adult males received two single doses of fedratinib (50 mg in Cohort 1 and 300 mg in Cohort 2) with one dose administered alone on Day 1 of Period 1 and the other dose coadministered with ketoconazole in the morning of Day 6 of Period 2. Subjects in both cohorts received 200-mg BID (Days 1-14) ketoconazole during Period 2.
RESULTS
Coadministration of repeated 200-mg BID oral doses of ketoconazole for 14 days increased fedratinib exposure by 3.85- and 3.06-fold for area under the plasma concentration-time curve from time zero to infinity following a single oral dose of fedratinib of 50 and 300 mg, respectively. Oral administration of a single dose of 50 or 300 mg of fedratinib, administered alone or coadministered with steady-state ketoconazole, was safe and tolerable in the healthy male subjects.
CONCLUSIONS
These results serve as the basis for fedratinib dose reduction when fedratinib is coadministered with strong CYP3A4 inhibitors.",2020,"RESULTS
Coadministration of repeated 200-mg BID oral doses of ketoconazole for 14 days increased fedratinib exposure by 3.85- and 3.06-fold for area under the plasma concentration-time curve from time zero to infinity following a single oral dose of fedratinib of 50 and 300 mg, respectively.","['adult patients with intermediate-2 or high-risk myelofibrosis in the United States', 'Two cohorts of healthy adult males', 'healthy subjects', 'healthy male subjects']","['fedratinib', 'ketoconazole', 'strong CYP3A4 inhibitor, ketoconazole', 'fedratinib, administered alone or coadministered with steady-state ketoconazole']",['fedratinib exposure'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0001815', 'cui_str': 'Myelosclerosis with myeloid metaplasia'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C3850053', 'cui_str': 'CYP3A4 Inhibitors'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",2.0,0.0528205,"RESULTS
Coadministration of repeated 200-mg BID oral doses of ketoconazole for 14 days increased fedratinib exposure by 3.85- and 3.06-fold for area under the plasma concentration-time curve from time zero to infinity following a single oral dose of fedratinib of 50 and 300 mg, respectively.","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ogasawara', 'Affiliation': 'Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, 07901, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Vanaja', 'Initials': 'V', 'LastName': 'Kanamaluru', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, 07901, USA.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Krishna', 'Affiliation': 'Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, 07901, USA. gopal.krishna@bms.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04067-3']
324,31733631,"Distinct acute effects of LSD, MDMA, and D-amphetamine in healthy subjects.","Lysergic acid diethylamide (LSD) is a classic psychedelic, 3,4-methylenedioxymethamphetamine (MDMA) is an empathogen, and D-amphetamine is a classic stimulant. All three substances are used recreationally. LSD and MDMA are being investigated as medications to assist psychotherapy, and D-amphetamine is used for the treatment of attention-deficit/hyperactivity disorder. All three substances induce distinct acute subjective effects. However, differences in acute responses to these prototypical psychoactive substances have not been characterized in a controlled study. We investigated the acute autonomic, subjective, and endocrine effects of single doses of LSD (0.1 mg), MDMA (125 mg), D-amphetamine (40 mg), and placebo in a randomized, double-blind, cross-over study in 28 healthy subjects. All of the substances produced comparable increases in hemodynamic effects, body temperature, and pupil size, indicating equivalent autonomic responses at the doses used. LSD and MDMA increased heart rate more than D-amphetamine, and D-amphetamine increased blood pressure more than LSD and MDMA. LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine. LSD also produced greater subjective drug effects, ego dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-amphetamine. LSD also induced greater impairments in subjective ratings of concentration, sense of time, and speed of thinking compared with MDMA and D-amphetamine. MDMA produced greater ratings of good drug effects, liking, high, and ego dissolution compared with D-amphetamine. D-Amphetamine increased ratings of activity and concentration compared with LSD. MDMA but not LSD or D-amphetamine increased plasma concentrations of oxytocin. None of the substances altered plasma concentrations of brain-derived neurotrophic factor. These results indicate clearly distinct acute effects of LSD, MDMA, and D-amphetamine and may assist the dose-finding in substance-assisted psychotherapy research.",2020,LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine.,"['healthy subjects', '28 healthy subjects']","['3,4-methylenedioxymethamphetamine', 'LSD, MDMA, and D-amphetamine', 'LSD', 'MDMA', 'placebo', 'Lysergic acid diethylamide (LSD', 'D-amphetamine, and D-amphetamine', 'D-amphetamine']","['hemodynamic effects, body temperature, and pupil size, indicating equivalent autonomic responses', 'blood pressure', 'subjective ratings of concentration, sense of time, and speed of thinking', 'ratings of activity and concentration', 'plasma concentrations of oxytocin', 'subjective drug effects, ego dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-amphetamine', 'LSD and MDMA increased heart rate', 'Consciousness scale and Mystical Experience Questionnaire', 'ratings of good drug effects, liking, high, and ego dissolution']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0021924', 'cui_str': 'Introversion'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.0410698,LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine.,"[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vizeli', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ley', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Duerig', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Nimmy', 'Initials': 'N', 'LastName': 'Varghese', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Eckert', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland. matthias.liechti@usb.ch.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0569-3']
325,32087182,Carbohydrate mouth rinse has no effects on behavioral or neuroelectric indices of cognition.,"Rinsing the mouth with a carbohydrate solution has been suggested as a means to enhance aspects of both physical and cognitive performance. However, evidence in support of these assertions is relatively weak. The purpose of this study was to investigate the effects of a carbohydrate mouth rinse solution on motor speed, inhibition, and sustained attention as indexed by both behavioral and neuroelectric measures. Using a double-blind, placebo-controlled, within-subjects crossover design, 50 college-aged young adults performed a battery of cognitive tasks both before and after rinsing their mouth for 10 s with 20 mL of either a carbohydrate mouth rinse solution or a sensory-matched placebo control solution. A simple tapping task was used as a measure of motor speed, a modified Eriksen flanker task was used to index inhibition, and a rapid visual information processing task was used as a measure of sustained attention. Participants demonstrated longer reaction times in the Flanker task after rinsing their mouths with the carbohydrate mouth rinse, relative to pretest. No differences in reaction time were observed for the placebo control condition. P3 latency in the Flanker task as an index of attentional processing speed was shorter at posttest than at pretest in the placebo control - but not the carbohydrate mouth rinse - condition. These results suggest that despite claims of cognitive enhancement, carbohydrate mouth rinses do not appear to alter motor speed, inhibition, or sustained attention as compared to a placebo control in non-physically-fatigued college-aged adults.",2020,P3 latency in the Flanker task as an index of attentional processing speed was shorter at posttest than at pretest in the placebo control - but not the carbohydrate mouth rinse - condition.,"['50 college-aged young adults', 'non-physically-fatigued college-aged adults']","['carbohydrate solution', 'placebo', 'Carbohydrate mouth rinse', 'carbohydrate mouth rinse solution', 'carbohydrate mouth rinse solution or a sensory-matched placebo control solution']","['longer reaction times', 'P3 latency', 'reaction time', 'index of attentional processing speed', 'behavioral or neuroelectric indices of cognition', 'motor speed, inhibition, and sustained attention as indexed by both behavioral and neuroelectric measures']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention, function (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0892886,P3 latency in the Flanker task as an index of attentional processing speed was shorter at posttest than at pretest in the placebo control - but not the carbohydrate mouth rinse - condition.,"[{'ForeName': 'Madison C', 'Initials': 'MC', 'LastName': 'Chandler', 'Affiliation': 'Department of Kinesiology, Michigan State University, 308 W. Circle Drive, East Lansing, MI 48824, United States of America. Electronic address: chand138@msu.edu.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'McGowan', 'Affiliation': 'Department of Kinesiology, Michigan State University, 308 W. Circle Drive, East Lansing, MI 48824, United States of America. Electronic address: mcgowa78@msu.edu.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Ferguson', 'Affiliation': 'Department of Kinesiology, Michigan State University, 308 W. Circle Drive, East Lansing, MI 48824, United States of America. Electronic address: fergu312@msu.edu.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Pontifex', 'Affiliation': 'Department of Kinesiology, Michigan State University, 308 W. Circle Drive, East Lansing, MI 48824, United States of America. Electronic address: pontifex@msu.edu.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.02.012']
326,32205201,Two-year clinical evaluation of a proanthocyanidins-based primer in non-carious cervical lesions: A double-blind randomized clinical trial.,"OBJECTIVES
This double-blind randomized clinical trial evaluated the influence of pre-treatment with proanthocyanidins (PA) from grape seed extract on the clinical behavior of a simplified etch-and-rinse adhesive placed in non-carious cervical lesions (NCCLs) over 6- and 24-months.
MATERIALS AND METHODS
A total of 135 restorations were randomly inserted in 45 subjects. The NCCLs were etched with 37 % phosphoric acid for 15 s and distributed into 3 groups: Control (PA0) - adhesive ExciTE F applied as per the manufacturer's recommendations; PA2 and PA5 groups - 2 wt% and 5 wt% PA solution, respectively, were applied for 60 s and washed for 30 s prior to application of the adhesive. The resin composite was placed incrementally and light-cured. The restorations were evaluated at baseline, 6 months (6 m) and 24 months (24 m) using both the FDI and USPHS criteria. Statistical analyses were carried out using Friedman repeated-measures analysis of variance by rank and the Wilcoxon test (α = 0.05).
RESULTS
The retention rates were 98 % (PA0), 98 % (PA2) and 83 % (PA5) after 6 m and 93 % (PA0), 89 % (PA2) and 70 % (PA5) after 24 m. Only PA5 resulted in a significant lower retention rate at 6 m and at 24 m compared with that of baseline (p = 0.03). All groups resulted in a significantly worse marginal adaptation and marginal staining for the FDI criteria when the baseline vs. the 24 m recall data were compared. These differences were considered clinically acceptable under the FDI criteria.
CONCLUSIONS
The application of PA as a primer did not result in clinical advantages after 24 m of clinical service, regardless of the concentration used.
CLINICAL RELEVANCE
It has been reported that PA, a collagen crosslinking agent, increases the durability of the dentin-resin interface. However, no effects were found clinically after 24 months.",2020,All groups resulted in a significantly worse marginal adaptation and marginal staining for the FDI criteria when the baseline vs. the 24 m recall data were compared.,"['non-carious cervical lesions', 'A total of 135 restorations were randomly inserted in 45\u2009subjects']","['phosphoric acid', 'proanthocyanidins (PA', 'proanthocyanidins-based primer']","['marginal adaptation and marginal staining for the FDI criteria', 'retention rate', 'retention rates']","[{'cui': 'C4274086', 'cui_str': 'Non carious lesion at cervical margin of tooth (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}]","[{'cui': 'C0031700', 'cui_str': 'Phosphoric acid'}, {'cui': 'C0072018', 'cui_str': 'proanthocyanidin'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",135.0,0.161651,All groups resulted in a significantly worse marginal adaptation and marginal staining for the FDI criteria when the baseline vs. the 24 m recall data were compared.,"[{'ForeName': 'Lidiane Costa', 'Initials': 'LC', 'LastName': 'de Souza', 'Affiliation': 'Postgraduate Program of Dentistry - Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Fortaleza, Ceará, Brazil. Electronic address: lidiane.csouza@yahoo.com.br.'}, {'ForeName': 'Nara Sousa', 'Initials': 'NS', 'LastName': 'Rodrigues', 'Affiliation': 'Postgraduate Program of Dentistry - Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Fortaleza, Ceará, Brazil. Electronic address: nara.sousa.rodrigues@gmail.com.'}, {'ForeName': 'Diana Araújo', 'Initials': 'DA', 'LastName': 'Cunha', 'Affiliation': 'Postgraduate Program of Dentistry - Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Fortaleza, Ceará, Brazil. Electronic address: araujo.diana@gmail.com.'}, {'ForeName': 'Victor Pinheiro', 'Initials': 'VP', 'LastName': 'Feitosa', 'Affiliation': 'Postgraduate Program of Dentistry - Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Fortaleza, Ceará, Brazil; Paulo Picanço School of Dentistry, Fortaleza, Ceará, Brazil. Electronic address: victorpfeitosa@hotmail.com.'}, {'ForeName': 'Sérgio Lima', 'Initials': 'SL', 'LastName': 'Santiago', 'Affiliation': 'Postgraduate Program of Dentistry - Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Fortaleza, Ceará, Brazil. Electronic address: sergiosantiago@yahoo.com.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'School of Dentistry, Department of Restorative Dentistry, State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil. Electronic address: reis_ale@hotmail.com.'}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'School of Dentistry, Department of Restorative Dentistry, State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil. Electronic address: aloguercio@hotmail.com.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Perdigão', 'Affiliation': 'Department of Restorative Sciences, University of Minnesota, Minneapolis, MN, USA. Electronic address: perdi001@umn.edu.'}, {'ForeName': 'Vicente de Paulo Aragão', 'Initials': 'VPA', 'LastName': 'Saboia', 'Affiliation': 'Postgraduate Program of Dentistry - Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Fortaleza, Ceará, Brazil. Electronic address: vpsaboia@yahoo.com.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103325']
327,31539635,A simplified blood culture sampling protocol for reducing contamination and costs: a randomized controlled trial.,"OBJECTIVES
Blood culture contamination carries risks for patients, such as unnecessary antimicrobial therapy and other additional hazards and costs. One method shown to be effective in reducing contamination is initial blood specimen diversion during collection. We hypothesized that initial blood specimen diversion without a designated device or procedure would suffice for reduction in blood culture contamination rate.
METHODS
From 1 September 2017 through to 6 September 2018, we conducted a randomized controlled trial to assess the effect of an initial-specimen diversion technique (ISDT) on the rate of blood-culture contamination by changing the order of sampling using regular vacuum specimen tubes instead of commercially available sterile diversion devices. We included adults from whom the treating physician planned to take blood cultures and additional blood chemistry tests. Additionally, we evaluated the potential economic benefits of an ISDT. This was a researcher-initiated trial, Clinicaltrials.gov NCT03088865.
RESULTS
In all, 756 patients were enrolled. This method, compared with the standard procedure in use at our medical centre, reduced contamination by 66% (95% CI 17%-86%), from 20/400 (5%) with the standard method to 6/356 (1.6%) with the ISDT, without compromising detection of true bloodstream infection and at no additional cost. Hospital-wide implementation of ISDT was associated with a 1.1% saving in hospitalization days.
CONCLUSIONS
We offer this novel approach as a simple, cost-effective measure to reduce risks to patient safety from contaminated blood cultures, without the need for using costly devices.",2020,"Hospital-wide implementation of ISDT was associated with a 1.1% saving in hospitalization days.
","['adults from whom the treating physician planned to take blood cultures and additional blood chemistry tests', 'From September 1, 2017 through September 6, 2018', '756 patients were enrolled']",['initial specimen diversion technique (ISDT'],['contamination and costs'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}, {'cui': 'C0005774', 'cui_str': 'Blood Chemical Analysis'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0185033', 'cui_str': 'Diversion'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}]",756.0,0.121034,"Hospital-wide implementation of ISDT was associated with a 1.1% saving in hospitalization days.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lalezari', 'Affiliation': 'Hadassah-Hebrew University School of Medicine, Jerusalem, Israel.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': 'Hadassah-Hebrew University School of Medicine, Jerusalem, Israel.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Svinik', 'Affiliation': 'Hadassah-Hebrew University School of Medicine, Jerusalem, Israel.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Tel-Zur', 'Affiliation': 'Department of Emergency Medicine, Hadassah Medical Centre, Jerusalem, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sinvani', 'Affiliation': 'Department of Emergency Medicine, Hadassah Medical Centre, Jerusalem, Israel.'}, {'ForeName': 'Y Abed', 'Initials': 'YA', 'LastName': 'Al-Dayem', 'Affiliation': 'Department of Clinical Microbiology and Infectious Diseases, Hadassah Medical Centre, The Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Block', 'Affiliation': 'Hadassah-Hebrew University School of Medicine, Jerusalem, Israel; Department of Clinical Microbiology and Infectious Diseases, Hadassah Medical Centre, The Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Moses', 'Affiliation': 'Department of Clinical Microbiology and Infectious Diseases, Hadassah Medical Centre, The Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Oster', 'Affiliation': 'Department of Clinical Microbiology and Infectious Diseases, Hadassah Medical Centre, The Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Salameh', 'Affiliation': 'Department of Emergency Medicine, Hadassah Medical Centre, Jerusalem, Israel.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Strahilevitz', 'Affiliation': 'Hadassah-Hebrew University School of Medicine, Jerusalem, Israel; Department of Clinical Microbiology and Infectious Diseases, Hadassah Medical Centre, The Hebrew University, Jerusalem, Israel. Electronic address: jstrahilevitz@hadassah.org.il.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2019.09.005']
328,31669738,Enhanced recovery after surgery at cesarean delivery to reduce postoperative length of stay: a randomized controlled trial.,"OBJECTIVE
Our objective was to determine whether an enhanced recovery after surgery pathway at the time of cesarean birth would permit a reduction in postoperative length of stay and improve postoperative patient satisfaction compared to standard perioperative care.
MATERIALS AND METHODS
Patients undergoing nonemergent cesarean delivery at ≥37 weeks of gestation were randomized to enhanced recovery after surgery or standard care. Enhanced recovery after surgery involved multiple evidence-based interventions bundled into 1 protocol. The primary outcome was discharge on postoperative day 2. Secondary outcome variables included pain medication requirements, breastfeeding rates, and various measures of patient satisfaction.
RESULTS
From September 27, 2017, to May 2, 2018, a total of 58 women were randomized to enhanced recovery after surgery and 60 women to standard care. The groups were similar in medical comorbidities and in demographic and perioperative characteristics. Enhanced recovery after surgery was not associated with a significantly increased rate of postoperative day 2 discharges when compared with standard care (8.6% vs 3.3%, respectively; odds ratio, 2.74; 95% confidence interval, 0.51-14.70), but it was associated with a significantly reduced postoperative length of stay when compared with standard care, with a median length of stay of 73.5 hours (interquartile range, 71.08-76.62) vs 75.5 hours (interquartile range, 72.86-76.84) from surgery, difference in median length of stay (-1.92; 95% confidence interval, -3.80 to -0.29). Enhanced recovery after surgery was not associated with a reduction in postoperative narcotic use (117.16 ± 54.17 vs 119.38 ± 47.98 morphine milligram equivalents; mean difference, -2.22; 95% confidence interval, -20.86 to 16.42). More subjects randomized to the enhanced recovery after surgery protocol reported breastfeeding at discharge (67.2% vs 48.3%; P = .046). When patients were surveyed 6 weeks postpartum, those in the enhanced recovery after surgery group were more likely to feel that their expectations were met and that they had achieved their postoperative milestones earlier, and to report continued breastfeeding.
CONCLUSION
Enhanced recovery after surgery at cesarean delivery was not associated with an increase in the number of women discharged on postoperative day 2, but that may have been related to factors other than patients' medical readiness for discharge. Evidence that enhanced recovery after surgery at cesarean delivery may have the potential to improve outcomes such as day of discharge is suggested by the observed reduction in overall postoperative length of stay, improved patient satisfaction, and an increase in breastfeeding rates. Even better results may accrue with more provider and patient experience with enhanced recovery after surgery.",2020,"ERAS was not associated with a reduction in postoperative narcotic use, 117.16 ± 54.17 vs. 119.38 ± 47.98 morphine milligram equivalents (Mean difference: -2.22, 95% CI -20.86-16.42).","['Patients undergoing nonemergent cesarean delivery at ≥ 37 weeks of gestation', 'From September 27, 2017 to May 2, 2018, 58 women']","['ERAS or SC', 'ERAS']","['discharge on postoperative day 2 (POD#2', 'postoperative length of stay (LOS', 'Postoperative Length of Stay', 'pain medication requirements, breastfeeding rates and various measures of patient satisfaction', 'rate of POD#2 discharges', 'breastfeeding rates', 'median LOS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",58.0,0.216052,"ERAS was not associated with a reduction in postoperative narcotic use, 117.16 ± 54.17 vs. 119.38 ± 47.98 morphine milligram equivalents (Mean difference: -2.22, 95% CI -20.86-16.42).","[{'ForeName': 'Nickolas C', 'Initials': 'NC', 'LastName': 'Teigen', 'Affiliation': 'Georgia Perinatal Consultants, Atlanta, GA. Electronic address: nickolas.teigen@gmail.com.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sahasrabudhe', 'Affiliation': 'Department of Obstetrics & Gynecology, Kaiser Permanente Southern California, Downey, CA.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Doulaveris', 'Affiliation': ""Department of Obstetrics & Gynecology and Women's Health, Albert Einstein College of Medicine / Montefiore Medical Center, Bronx, NY.""}, {'ForeName': 'Xianhong', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine / Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Abdissa', 'Initials': 'A', 'LastName': 'Negassa', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine / Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bernstein', 'Affiliation': 'Department of Anesthesia, New York University, New York, NY.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Bernstein', 'Affiliation': ""Department of Obstetrics & Gynecology and Women's Health, Albert Einstein College of Medicine / Montefiore Medical Center, Bronx, NY.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.10.009']
329,32251176,Effects of Aspirin on Postoperative Bruising and Bleeding Complications in Upper Eyelid Surgery.,"PURPOSE
We evaluated the effects of aspirin versus placebo in patients undergoing upper eyelid blepharoplasty and/or levator advancement or plication blepharoptosis repair in this randomized, prospective study.
METHODS
Patients who presented between October 2017 and April 2019 requiring blepharoptosis repair and/or upper eyelid blepharoplasty who were taking 81 mg aspirin were randomized to receive 1 week of aspirin tablets or 1 week of placebo tablets prior to surgery. Postoperative complications, such as bleeding, hematoma, or hemorrhage, were noted as well as perioperative thromboembolic complications. Photos were obtained at the patient's first postoperative visit and later judged on bruising severity. The 2 groups were subsequently compared.
RESULTS
A total of 48 patients and 89 eyelids were evaluated in this study. Fifty-two eyelids were included in the aspirin group and 37 eyelids were included in the placebo group. There was no statistically significant difference in bruising rating between groups. There was no statistically significant difference in the number of patients who experienced mild postoperative bleeding. No patients experienced vision loss. No patients experienced a thromboembolic event. There were no patients who experienced hemorrhage, hematoma, or retrobulbar hemorrhage.
CONCLUSIONS
Continuation of aspirin does not appear to effect outcomes with respect to postoperative bruising in patients undergoing upper eyelid blepharoplasty or blepharoptosis repair. The study was not powered to determine statistical significance with regard to bleeding complications and would require a significantly higher sample size. We suggest changing the current guidelines to recommend routine continuation of low dose 81 mg aspirin before upper eyelid surgery.",2020,"CONCLUSIONS
Continuation of aspirin does not appear to effect outcomes with respect to postoperative bruising in patients undergoing upper eyelid blepharoplasty or blepharoptosis repair.","['Fifty-two eyelids were included in the aspirin group and 37 eyelids were included in the placebo group', 'patients undergoing upper eyelid blepharoplasty or blepharoptosis repair', '48 patients and 89 eyelids', 'patients undergoing upper eyelid blepharoplasty and/or levator advancement or plication blepharoptosis repair', 'Upper Eyelid Surgery', 'Patients who presented between October 2017 and April 2019 requiring blepharoptosis repair and/or upper eyelid blepharoplasty who were taking 81 mg']","['aspirin tablets', 'aspirin', 'Aspirin', 'placebo tablets prior to surgery', 'aspirin versus placebo']","['bruising severity', 'vision loss', 'bleeding complications', 'mild postoperative bleeding', 'bruising rating', 'Postoperative complications, such as bleeding, hematoma, or hemorrhage', 'Postoperative Bruising and Bleeding Complications', 'thromboembolic event', 'hemorrhage, hematoma, or retrobulbar hemorrhage', 'perioperative thromboembolic complications']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0197216', 'cui_str': 'Blepharoplasty of upper eyelid'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0585636', 'cui_str': 'Upper eyelid structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C1244632', 'cui_str': 'Aspirin Oral Tablet'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0302497', 'cui_str': 'Retrobulbar hemorrhage'}]",52.0,0.0759774,"CONCLUSIONS
Continuation of aspirin does not appear to effect outcomes with respect to postoperative bruising in patients undergoing upper eyelid blepharoplasty or blepharoptosis repair.","[{'ForeName': 'Kathryn P', 'Initials': 'KP', 'LastName': 'Winker', 'Affiliation': 'DuPage Medical Group Eye Specialists, Downers Grove, Illinois.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Beaulieu', 'Affiliation': 'Consultants in Ophthalmic and Facial Plastic Surgery, Southfield, Michigan.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Bevill', 'Affiliation': 'Consultants in Ophthalmic and Facial Plastic Surgery, Southfield, Michigan.'}, {'ForeName': 'Aleksey', 'Initials': 'A', 'LastName': 'Mishulin', 'Affiliation': 'Kresge Eye Institute, Detroit, Michigan.'}, {'ForeName': 'Evan H', 'Initials': 'EH', 'LastName': 'Black', 'Affiliation': 'Consultants in Ophthalmic and Facial Plastic Surgery, Southfield, Michigan.'}]",Ophthalmic plastic and reconstructive surgery,['10.1097/IOP.0000000000001652']
330,31977595,Brief Report: Virologic Response by Baseline Viral Load With Dolutegravir Plus Lamivudine vs Dolutegravir Plus Tenofovir Disoproxil Fumarate/Emtricitabine: Pooled Analysis.,"BACKGROUND
To investigate antiviral potency of the 2-drug regimen (2DR) dolutegravir plus lamivudine vs the 3-drug regimen (3DR) dolutegravir plus tenofovir disoproxil fumarate/emtricitabine, we performed a post-hoc analysis assessing antiviral response rates in the phase III GEMINI-1 and GEMINI-2 studies by baseline viral load (VL).
SETTING
One hundred ninety-two centers in 21 countries.
METHODS
Treatment-naive HIV-1-infected participants with screening VL ≤500,000 copies/mL were randomized 1:1 to once-daily dolutegravir plus lamivudine or dolutegravir plus tenofovir disoproxil fumarate/emtricitabine. Median change from baseline was determined for log10-transformed VL in the overall study population and the subpopulation with baseline VL >100,000 copies/mL. Proportion of participants achieving plasma VL <50 copies/mL (Snapshot algorithm) or <40 copies/mL (Abbott RealTime HIV-1 assay) and target not detected was assessed through week 48 by baseline VL. Time to viral suppression was determined (nonparametric Kaplan-Meier method).
RESULTS
For 293 participants with baseline VL >100,000 copies/mL, median change from baseline at week 4 was -3.38 and -3.40 log10 copies/mL in the 2DR and 3DR groups, respectively; reduction was sustained throughout 48 weeks. Time to VL <50 copies/mL was longer in participants with baseline VL >100,000 copies/mL than the overall study population (57 [week 8] vs 29 days [week 4]) and similar between the 2DR and 3DR groups. Proportion of participants with VL <50 or <40 copies/mL and target not detected was similar between groups, irrespective of baseline VL, at all tested visits throughout 48 weeks.
CONCLUSION
Dolutegravir plus lamivudine demonstrates high antiviral potency in treatment-naive HIV-1-infected individuals across baseline VL strata.",2020,"Time to VL <50 copies/mL was longer in participants with baseline VL >100,000 copies/mL than the overall study population (57 [Week 8] vs 29 days [Week 4]) and similar between the 2DR and 3DR groups.","['Treatment-naive HIV-1-infected participants with screening VL <500,000 copies/mL', '192 centers in 21 countries']","['Dolutegravir plus lamivudine', 'daily dolutegravir plus lamivudine or dolutegravir plus tenofovir disoproxil fumarate/emtricitabine', 'lamivudine', 'Dolutegravir Plus Lamivudine vs Dolutegravir Plus Tenofovir Disoproxil Fumarate/Emtricitabine', 'tenofovir disoproxil fumarate/emtricitabine']","['antiviral potency', 'Time to viral suppression', 'antiviral response rates', 'Virologic Response']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0205466', 'cui_str': 'virology'}]",293.0,0.414981,"Time to VL <50 copies/mL was longer in participants with baseline VL >100,000 copies/mL than the overall study population (57 [Week 8] vs 29 days [Week 4]) and similar between the 2DR and 3DR groups.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Eron', 'Affiliation': 'University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Chien-Ching', 'Initials': 'CC', 'LastName': 'Hung', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Jean-Guy', 'Initials': 'JG', 'LastName': 'Baril', 'Affiliation': 'Clinique Médicale du Quartier Latin, Montréal, Québec, Canada.'}, {'ForeName': 'Jihad', 'Initials': 'J', 'LastName': 'Slim', 'Affiliation': ""Saint Michael's Medical Center, Newark, NJ.""}, {'ForeName': 'Vicenç', 'Initials': 'V', 'LastName': 'Falcó', 'Affiliation': ""Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bogner', 'Affiliation': 'Internal Medicine IV, University Hospital Munich, Munich, Germany.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Maggiolo', 'Affiliation': 'ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mills', 'Affiliation': ""Men's Health Foundation, Los Angeles CA.""}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Sievers', 'Affiliation': 'ViiV Healthcare, Brentford, United Kingdom.'}, {'ForeName': 'Choy Y', 'Initials': 'CY', 'LastName': 'Man', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Rimgaile', 'Initials': 'R', 'LastName': 'Urbaityte', 'Affiliation': 'GlaxoSmithKline, London, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Allan R', 'Initials': 'AR', 'LastName': 'Tenorio', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Pappa', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Wynne', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Koteff', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gartland', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Smith', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aboud', 'Affiliation': 'ViiV Healthcare, Brentford, United Kingdom.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002302']
331,22374991,"Gastric cancer incidence among Hispanics in California: patterns by time, nativity, and neighborhood characteristics.","BACKGROUND
Better understanding about gastric cancer incidence patterns among Hispanics by birthplace, socioeconomic status (SES), and acculturation can improve preventive strategies and disease models.
METHODS
Incidence rates, rate ratios, and estimated annual percent change (EAPC) in rates of anatomic and histologic subtype-specific gastric cancer were calculated by age, sex, and nativity among Hispanics using California Cancer Registry data from 1988 through 2004. Incidence rates in 1998 to 2002 were compared by neighborhood SES and Hispanic enclave status according to 2000 US Census data.
RESULTS
Incidence rates of diffuse gastric cancer increased from 1988 through 2004 among foreign-born Hispanic men (EAPC: 3.5%, 95% CI: 1.5%-5.5%) and U.S.-born Hispanic women (EAPC: 3.0%, 95% CI: 0.7%-5.3%). During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women. Noncardia and both intestinal and diffuse gastric cancer were more common in foreign-born than U.S.-born Hispanic men and women, and in those from lower SES, higher enclave neighborhoods. By contrast, among younger and middle-aged Hispanic men, cardia tumors were more common in the U.S.-born than the foreign-born, and in higher SES, lower enclave neighborhoods.
CONCLUSIONS
Varying gastric cancer risk factors among Hispanic subgroups and increasing rates of diffuse gastric cancer in foreign-born Hispanic men and U.S.-born Hispanic women merit further investigation to identify separate disease etiologies.
IMPACT
Age, sex, birthplace, SES, and acculturation modify gastric cancer incidence in Hispanics and should be considered when examining disease risk and prevention.",2012,"During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women.","['foreign-born Hispanic men and U.S.-born Hispanic women', 'younger and middle-aged Hispanic men, cardia tumors', 'Hispanics in California']",[],"['Noncardia and both intestinal and diffuse gastric cancer', 'Incidence rates', 'time, nativity, and neighborhood characteristics', 'cardia and noncardia gastric cancer', 'Incidence rates of diffuse gastric cancer', 'Incidence rates, rate ratios, and estimated annual percent change (EAPC) in rates of anatomic and histologic subtype-specific gastric cancer', 'Gastric cancer incidence', 'incidence rates of intestinal gastric cancer']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0006754', 'cui_str': 'California'}]",[],"[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",,0.019428,"During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women.","[{'ForeName': 'Ellen T', 'Initials': 'ET', 'LastName': 'Chang', 'Affiliation': 'Cancer Prevention Institute of California, Fremont, CA, USA. echang@exponent.com'}, {'ForeName': 'Scarlett Lin', 'Initials': 'SL', 'LastName': 'Gomez', 'Affiliation': ''}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Fish', 'Affiliation': ''}, {'ForeName': 'Clayton W', 'Initials': 'CW', 'LastName': 'Schupp', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Parsonnet', 'Affiliation': ''}, {'ForeName': 'Mindy C', 'Initials': 'MC', 'LastName': 'DeRouen', 'Affiliation': ''}, {'ForeName': 'Theresa H M', 'Initials': 'TH', 'LastName': 'Keegan', 'Affiliation': ''}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Clarke', 'Affiliation': ''}, {'ForeName': 'Sally L', 'Initials': 'SL', 'LastName': 'Glaser', 'Affiliation': ''}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-11-1208']
332,30606273,Enhancing return to work or school after a first episode of schizophrenia: the UCLA RCT of Individual Placement and Support and Workplace Fundamentals Module training.,"BACKGROUND
This study evaluated in a rigorous 18-month randomized controlled trial the efficacy of an enhanced vocational intervention for helping individuals with a recent first schizophrenia episode to return to and remain in competitive work or regular schooling.
METHODS
Individual Placement and Support (IPS) was adapted to meet the goals of individuals whose goals might involve either employment or schooling. IPS was combined with a Workplace Fundamentals Module (WFM) for an enhanced, outpatient, vocational intervention. Random assignment to the enhanced integrated rehabilitation program (N = 46) was contrasted with equally intensive clinical treatment at UCLA, including social skills training groups, and conventional vocational rehabilitation by state agencies (N = 23). All patients were provided case management and psychiatric services by the same clinical team and received oral atypical antipsychotic medication.
RESULTS
The IPS-WFM combination led to 83% of patients participating in competitive employment or school in the first 6 months of intensive treatment, compared with 41% in the comparison group (p < 0.005). During the subsequent year, IPS-WFM continued to yield higher rates of schooling/employment (92% v. 60%, p < 0.03). Cumulative number of weeks of schooling and/or employment was also substantially greater with the IPS-WFM intervention (45 v. 26 weeks, p < 0.004).
CONCLUSIONS
The results clearly support the efficacy of an enhanced intervention focused on recovery of participation in normative work and school settings in the initial phase of schizophrenia, suggesting potential for prevention of disability.",2020,"RESULTS
The IPS-WFM combination led to 83% of patients participating in competitive employment or school in the first 6 months of intensive treatment, compared with 41% in the comparison group (p < 0.005).",['helping individuals with a recent first schizophrenia episode to return to and remain in competitive work or regular schooling'],"['enhanced vocational intervention', 'oral atypical antipsychotic medication', 'Individual Placement and Support (IPS', 'IPS was combined with a Workplace Fundamentals Module (WFM', 'enhanced integrated rehabilitation program (N = 46) was contrasted with equally intensive clinical treatment at UCLA, including social skills training groups, and conventional vocational rehabilitation by state agencies']",['Cumulative number of weeks of schooling and/or employment'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1276996', 'cui_str': 'Atypical antipsychotic'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0034996', 'cui_str': 'Vocational rehabilitation (regime/therapy)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]",,0.0231509,"RESULTS
The IPS-WFM combination led to 83% of patients participating in competitive employment or school in the first 6 months of intensive treatment, compared with 41% in the comparison group (p < 0.005).","[{'ForeName': 'Keith H', 'Initials': 'KH', 'LastName': 'Nuechterlein', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Subotnik', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ventura', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Luana R', 'Initials': 'LR', 'LastName': 'Turner', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Gitlin', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Gretchen-Doorly', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Deborah R', 'Initials': 'DR', 'LastName': 'Becker', 'Affiliation': 'Department of Community and Family Medicine, Geisel School of Medicine at Dartmouth, Lebanon, NH, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Drake', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine at Dartmouth, Lebanon, NH, USA.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Wallace', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Liberman', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.'}]",Psychological medicine,['10.1017/S0033291718003860']
333,31421272,The effects of topical antibiotics on eradication and acquisition of third-generation cephalosporin and carbapenem-resistant Gram-negative bacteria in ICU patients; a post hoc analysis from a multicentre cluster-randomized trial.,"OBJECTIVES
The aim was to quantify the effects of selective digestive tract decontamination (SDD) consisting of a mouth paste and gastro-enteral suspension, selective oropharyngeal decontamination with a mouth paste (SOD) and 1-2% chlorhexidine (CHX) mouthwash on eradication and acquisition of carriage of third-generation cephalosporin-resistant Enterobacterales (3GCR-E) and carbapenem-resistant Gram-negative bacteria (CR-GNB) in Intensive Care Unit (ICU) patients.
METHODS
This was a nested cohort study within a cluster-randomized cross-over trial in six European countries and 13 ICUs with 8665 patients. Eradication and acquisition during ICU stay of 3GCR-E and CR-GNB were investigated separately in the rectum and respiratory tract for the three interventions and compared with standard care (SC) using Cox-regression competing events analyses.
RESULTS
Adjusted cause specific hazard ratios (CSHR) for eradication of rectal carriage for SDD were 1.76 (95% CI 1.31-2.36) for 3GCR-E and 3.17 (95% CI 1.60-6.29) for CR-GNB compared with SC. For the respiratory tract, adjusted CSHR for eradication of 3GCR-E were 1.47 (0.98-2.20) for SDD and 1.38 (0.92-2.06) for SOD compared with SC, and for eradication of CR-GNB these were 0.77 (0.41- 1.45) for SDD and 0.81 (0.44-1.51) for SOD, compared with SC. Adjusted CSHRs for acquisition of rectal carriage during SDD (compared with SC) were 0.51 (0.40-0.64) for 3GCR-E and of 0.56 (0.40-0.78) for CR-GNB. Adjusted CSHRs for acquiring respiratory tract carriage with 3GCR-E compared with SC were 0.38 (0.28-0.50) for SDD and 0.55 (0.42-0.71) for SOD, and for CR-GNB 0.46 (0.33-0.64) during SDD and 0.60 (0.44-0.81) during SOD, respectively. SOD was not associated with eradication or acquisition of 3GCR-E and CR-GNB in the rectum.
CONCLUSIONS
Among mechanically ventilated ICU patients, SDD was associated with more eradication and less acquisition of 3GCR-E and CR-GNB in the rectum than SC. SDD and SOD were associated with less acquisition of both 3GCR-E and CR-GNB than SC in the respiratory tract.",2020,"SDD and SOD were associated with less acquisition of both 3GCR-E and CR-GNB, compared to SC, in the respiratory tract.","['ICU patients', 'Nested cohort study within a cluster-randomized cross-over trial in 6 European countries and 13 ICUs with 8,665 patients']","['topical antibiotics', 'cephalosporin and carbapenem resistant Gram-negative bacteria', 'selective digestive tract decontamination (SDD) consisting of a mouth paste and gastro-enteral suspension, selective oropharyngeal decontamination with a mouth paste (SOD) and 1-2% chlorhexidine (CHX) mouthwash']","['Adjusted CSHRs for acquisition of rectal carriage during SDD', 'specific hazard ratios (CSHR) for eradication of rectal carriage for SDD', 'eradication and acquisition of carriage of third generation cephalosporin-resistant Enterobacterales (3GCR-E) and carbapenem resistant Gram-negative bacteria (CR-GNB', 'SDD and SOD', 'Eradication and acquisition during ICU stay of 3GCR-E and CR-GNB']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C4706514', 'cui_str': 'Cephalosporin product'}, {'cui': 'C0006968', 'cui_str': 'Antibiotics, Carbapenem'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0018150', 'cui_str': 'Gram-Negative Bacteria'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal Tract'}, {'cui': 'C0011121', 'cui_str': 'Decontamination'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C3666901', 'cui_str': 'Chlorhexidine Mouthwash [Paroex]'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0074222', 'cui_str': 'sulfamoyldapsone'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0304320', 'cui_str': 'Third generation cephalosporin (substance)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0006968', 'cui_str': 'Antibiotics, Carbapenem'}, {'cui': 'C0018150', 'cui_str': 'Gram-Negative Bacteria'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]",,0.110214,"SDD and SOD were associated with less acquisition of both 3GCR-E and CR-GNB, compared to SC, in the respiratory tract.","[{'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Plantinga', 'Affiliation': 'Department of Medical Microbiology, Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, the Netherlands.'}, {'ForeName': 'B H J', 'Initials': 'BHJ', 'LastName': 'Wittekamp', 'Affiliation': 'Intensive Care Centre, Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, the Netherlands. Electronic address: b.h.j.wittekamp@umcutrecht.nl.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Brun-Buisson', 'Affiliation': 'Medical ICU & Infection Control Unit, Hôpital Henri Mondor, Université Paris-Est Créteil, France.'}, {'ForeName': 'M J M', 'Initials': 'MJM', 'LastName': 'Bonten', 'Affiliation': 'Department of Medical Microbiology, Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2019.08.001']
334,32248846,Physiological responses to maximal eating in men.,"This study investigated metabolic, endocrine, appetite and mood responses to a maximal eating occasion in fourteen men (mean: age 28 (sd 5) years, body mass 77·2 (sd 6·6) kg and BMI 24·2 (sd 2·2) kg/m2) who completed two trials in a randomised crossover design. On each occasion, participants ate a homogenous mixed-macronutrient meal (pizza). On one occasion, they ate until 'comfortably full' (ad libitum) and on the other, until they 'could not eat another bite' (maximal). Mean energy intake was double in the maximal (13 024 (95 % CI 10 964, 15 084) kJ; 3113 (95 % CI 2620, 3605) kcal) compared with the ad libitum trial (6627 (95 % CI 5708, 7547) kJ; 1584 (95 % CI 1364, 1804) kcal). Serum insulin incremental AUC (iAUC) increased approximately 1·5-fold in the maximal compared with ad libitum trial (mean: ad libitum 43·8 (95 % CI 28·3, 59·3) nmol/l × 240 min and maximal 67·7 (95 % CI 47·0, 88·5) nmol/l × 240 min, P < 0·01), but glucose iAUC did not differ between trials (ad libitum 94·3 (95 % CI 30·3, 158·2) mmol/l × 240 min and maximal 126·5 (95 % CI 76·9, 176·0) mmol/l × 240 min, P = 0·19). TAG iAUC was approximately 1·5-fold greater in the maximal v. ad libitum trial (ad libitum 98·6 (95 % CI 69·9, 127·2) mmol/l × 240 min and maximal 146·4 (95 % CI 88·6, 204·1) mmol/l × 240 min, P < 0·01). Total glucagon-like peptide-1, glucose-dependent insulinotropic peptide and peptide tyrosine-tyrosine iAUC were greater in the maximal compared with ad libitum trial (P < 0·05). Total ghrelin concentrations decreased to a similar extent, but AUC was slightly lower in the maximal v. ad libitum trial (P = 0·02). There were marked differences on appetite and mood between trials, most notably maximal eating caused a prolonged increase in lethargy. Healthy men have the capacity to eat twice the energy content required to achieve comfortable fullness at a single meal. Postprandial glycaemia is well regulated following initial overeating, with elevated postprandial insulinaemia probably contributing.",2020,"Total GLP-1, GIP, and PYY iAUC were greater in the maximal compared with ad libitum trial (p < 0.05).","['Healthy men', 'fourteen men (mean ±SD: age 28 ±5 y, body mass 77.2 ±6.6 kg, body mass index 24.2 ±2.2 kg·m-2', 'men']",['homogenous mixed-macronutrient meal (pizza'],"['Postprandial glycaemia', 'comfortable fullness', 'lethargy', 'glucose', 'iAUC', 'Total GLP-1, GIP, and PYY iAUC', 'appetite and mood', 'TAG iAUC', 'Serum insulin iAUC', 'Total ghrelin concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0453577', 'cui_str': 'Pizza'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0037293', 'cui_str': 'Skin tag'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0966749,"Total GLP-1, GIP, and PYY iAUC were greater in the maximal compared with ad libitum trial (p < 0.05).","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hengist', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Edinburgh', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Russell G', 'Initials': 'RG', 'LastName': 'Davies', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Walhin', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Jariya', 'Initials': 'J', 'LastName': 'Buniam', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, LoughboroughLE11 3TU, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'School of Psychological Science, University of Bristol, BristolBS8 1TU, UK.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, BathBA2 7AY, UK.'}]",The British journal of nutrition,['10.1017/S0007114520001270']
335,32249112,Vitamin A and iron status of children before and after treatment of uncomplicated severe acute malnutrition.,"BACKGROUND & AIMS
Treatment of children with uncomplicated severe acute malnutrition (SAM) is based on ready-to-use therapeutic foods (RUTF) and aims for quick regain of lost body tissues while providing sufficient micronutrients to restore diminished body stores. Little evidence exists on the success of the treatment to establish normal micronutrient status. We aimed to assess the changes in vitamin A and iron status of children treated for SAM with RUTF, and explore the effect of a reduced RUTF dose.
METHODS
We collected blood samples from children 6-59 months old with SAM included in a randomised trial at admission to and discharge from treatment and analysed haemoglobin (Hb) and serum concentrations of retinol binding protein (RBP), ferritin (SF), soluble transferrin receptor (sTfR), C-reactive protein (CRP) and α1-acid glycoprotein (AGP). SF, sTfR and RBP were adjusted for inflammation (CRP and AGP) prior to analysis using internal regression coefficients. Vitamin A deficiency (VAD) was defined as RBP < 0.7 μmol/l, anaemia as Hb < 110 g/l, storage iron deficiency (sID) as SF < 12 μg/l, tissue iron deficiency (tID) as sTfR > 8.3 mg/l and iron deficiency anaemia (IDA) as both anaemia and sID. Linear and logistic mixed models were fitted including research team and study site as random effects and adjusting for sex, age and outcome at admission.
RESULTS
Children included in the study (n = 801) were on average 13 months of age at admission to treatment and the median treatment duration was 56 days [IQR: 35; 91] in both arms. Vitamin A and iron status markers did not differ between trial arms at admission or at discharge. Only Hb was 1.7 g/l lower (95% CI -0.3, 3.7; p = 0.088) in the reduced dose arm compared to the standard dose, at recovery. Mean concentrations of all biomarkers improved from admission to discharge: Hb increased by 12% or 11.6 g/l (95% CI 10.2, 13.0), RBP increased by 13% or 0.12 μmol/l (95% CI 0.09, 0.15), SF increased by 36% or 4.4 μg/l (95% CI 3.1, 5.7) and sTfR decreased by 16% or 1.5 mg/l (95% CI 1.0, 1.9). However, at discharge, micronutrient deficiencies were still common, as 9% had VAD, 55% had anaemia, 35% had sID, 41% had tID and 21% had IDA.
CONCLUSION
Reduced dose of RUTF did not result in poorer vitamin A and iron status of children. Only haemoglobin seemed slightly lower at recovery among children treated with the reduced dose. While improvement was observed, the vitamin A and iron status remained sub-optimal among children treated successfully for SAM with RUTF. There is a need to reconsider RUTF fortification levels or test other potential strategies in order to fully restore the micronutrient status of children treated for SAM.",2020,Mean concentrations of all biomarkers improved from admission to discharge:,"['children 6-59 months old with SAM', 'children treated for SAM with RUTF', 'uncomplicated severe acute malnutrition', 'children with uncomplicated severe acute malnutrition (SAM']",['RUTF'],"['Vitamin A deficiency (VAD', 'SF, sTfR and RBP', 'RBP', 'sTfR', 'haemoglobin (Hb) and serum concentrations of retinol binding protein (RBP), ferritin (SF), soluble transferrin receptor (sTfR), C-reactive protein (CRP) and α1-acid glycoprotein (AGP', 'poorer vitamin A and iron status of children', 'Vitamin A and iron status markers', 'Mean concentrations of all biomarkers improved from admission to discharge', 'SF', 'vitamin A and iron status']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}]",[],"[{'cui': 'C0042842', 'cui_str': 'Vitamin A deficiency'}, {'cui': 'C0077973', 'cui_str': 'VAD I protocol'}, {'cui': 'C0035342', 'cui_str': 'Retinol binding protein'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0029297', 'cui_str': 'Alpha-1- acid glycoprotein'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",801.0,0.256018,Mean concentrations of all biomarkers improved from admission to discharge:,"[{'ForeName': 'Suvi T', 'Initials': 'ST', 'LastName': 'Kangas', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark; Expertise and Advocacy Department, Action Against Hunger (ACF), Paris, France. Electronic address: suvi_kangas@hotmail.com.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Salpéteur', 'Affiliation': 'Expertise and Advocacy Department, Action Against Hunger (ACF), Paris, France.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Nikièma', 'Affiliation': 'Nutrition and Health Department, Action Against Hunger (ACF) Mission, Burkina Faso.'}, {'ForeName': 'Leisel', 'Initials': 'L', 'LastName': 'Talley', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Briend', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark; Center for Child Health Research, University of Tampere School of Medicine, Tampere University, FIN-33014, Tampere Finland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Friis', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Kaestel', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.03.016']
336,32242826,Effectiveness of Message Frame-Tailoring in a Web-Based Smoking Cessation Program: Randomized Controlled Trial.,"BACKGROUND
The content of online computer-tailored interventions is often determined to match an individual's characteristics, beliefs, and behavioral factors. These content-tailored interventions lead to better message processing and a higher likelihood of behavior change such as smoking cessation. However, a meta-analysis of online computer-tailored interventions showed that effect sizes, albeit positive, remain small, suggesting room for improvement. A promising strategy to enhance the effectiveness of online computer-tailored interventions is to tailor the message frame (ie, how a message is communicated) based on the preferred communication style of the user in addition to content-tailoring. One factor that determines an individual's communication style preference is the need for autonomy; some individuals prefer an autonomy-supportive communication style (offering choice and use of suggestive language), whereas others might prefer a directive communication style, which is replete with imperatives and does not provide choice. Tailoring how messages are presented (eg, based on the need for autonomy) is called message frame-tailoring.
OBJECTIVE
The aim of the present study was to test the effectiveness of message frame-tailoring based on the need for autonomy, in isolation and in combination with content-tailoring, within the context of an online computer-tailored smoking cessation intervention. The primary outcome measure was the 7-day point-prevalence of smoking abstinence. Secondary outcomes were perceived message relevance, self-determined motivation to quit smoking, and sociocognitive beliefs.
METHODS
A randomized controlled trial with a 2 (message frame-tailoring vs no message frame-tailoring) by 2 (content-tailoring vs no content-tailoring) design was conducted among adult smokers intending to quit smoking (N=273).
RESULTS
Structural equation modeling revealed that the content-tailored condition increased smoking abstinence rates 1 month after the start of the intervention (beta=.57, P=.02). However, neither message frame-tailoring nor its interaction with content-tailoring significantly predicted smoking abstinence. In our model, message frame-tailoring, content-tailoring, as well as their interaction significantly predicted perceived relevance of the smoking cessation messages, which consequently predicted self-determined motivation. In turn, self-determined motivation positively affected attitudes and self-efficacy for smoking cessation, but only self-efficacy consequently predicted smoking abstinence. Participants in the control condition perceived the highest level of message relevance (mean 4.78, SD 1.27). However, messages that were frame-tailored for individuals with a high need for autonomy in combination with content-tailored messages led to significantly higher levels of perceived message relevance (mean 4.83, SD 1.03) compared to those receiving content-tailored messages only (mean 4.24, SD 1.05, P=.003).
CONCLUSIONS
Message frame-tailoring based on the need for autonomy seems to be an effective addition to conventional content-tailoring techniques in online smoking cessation interventions for people with a high need for autonomy; however, this is not effective in its current form for people with a low need for autonomy.
TRIAL REGISTRATION
Dutch Trial Register (NL6512/NRT-6700); https://www.trialregister.nl/trial/6512.",2020,"RESULTS
Structural equation modeling revealed that the content-tailored condition increased smoking abstinence rates 1 month after the start of the intervention (beta=.57, P=.02).","['adult smokers intending to quit smoking (N=273', 'a Web-Based Smoking Cessation Program']",['2 (message frame-tailoring vs no message frame-tailoring) by 2 (content-tailoring vs no content-tailoring'],"['highest level of message relevance', '7-day point-prevalence of smoking abstinence', 'smoking abstinence rates', 'message relevance, self-determined motivation to quit smoking, and sociocognitive beliefs', 'smoking abstinence', 'levels of perceived message relevance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0512161,"RESULTS
Structural equation modeling revealed that the content-tailored condition increased smoking abstinence rates 1 month after the start of the intervention (beta=.57, P=.02).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Altendorf', 'Affiliation': 'Department of Communication Science, Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Ciska', 'Initials': 'C', 'LastName': 'Hoving', 'Affiliation': 'Department of Health Promotion, Care and Public Health Research Institute, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Julia Cm', 'Initials': 'JC', 'LastName': 'Van Weert', 'Affiliation': 'Department of Communication Science, Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Eline Suzanne', 'Initials': 'ES', 'LastName': 'Smit', 'Affiliation': 'Department of Communication Science, Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/17251']
337,32239968,Preterm Infants Fed Cow's Milk-Derived Fortifier Had Adverse Outcomes Despite a Base Diet of Only Mother's Own Milk.,"Objective: An increasingly common practice is to feed preterm infants a base diet comprising only human milk (HM), usually fortified with a cow's milk (CM)-derived fortifier (CMDF). We evaluated the safety of CMDF in a diet of 100% mother's own milk (MOM) against a HM-derived fortifier (HMDF). To date, this has received little research attention. Study Design: We reanalyzed a 12-center randomized trial, originally comparing exclusive HM feeding, including MOM, donor milk (DM), and HMDF, versus a CM exposed group fed MOM, preterm formula (PTF), and CMDF1. However, for the current study, we performed a subgroup analysis ( n = 114) selecting only infants receiving 100% MOM base diet plus fortification, and fed no DM or PTF. This allowed for an isolated comparison of fortifier type: CMDF versus HMDF to evaluate the primary outcomes: necrotizing enterocolitis (NEC) and a severe morbidity index of NEC surgery or death; and several secondary outcomes. Results: CMDF and HMDF groups had similar baseline characteristics. CMDF was associated with higher risk of NEC; relative risk (RR) 4.2 ( p = 0.038), NEC surgery or death (RR 5.1, p = 0.014); and reduced head circumference gain ( p = 0.04). Conclusions: In neonates fed, as currently recommended with a MOM-based diet, the safety of CMDF when compared to HMDF has been little researched. We conclude that available evidence points to an increase in adverse outcomes with CMDF, including NEC and severe morbidity comprising NEC surgery or death.",2020,"CMDF was associated with higher risk of NEC; relative risk (RR) 4.2 ( p = 0.038), NEC surgery or death (RR 5.1, p = 0.014); and reduced head circumference gain ( p = 0.04). ",[],"['CMDF', 'MOM base diet plus fortification, and fed no DM or PTF', 'MOM, donor milk (DM), and HMDF, versus a CM exposed group fed MOM, preterm formula (PTF), and CMDF1']","['adverse outcomes with CMDF, including NEC and severe morbidity comprising NEC surgery or death', 'NEC surgery or death', 'head circumference gain']",[],"[{'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206695', 'cui_str': 'Neuroendocrine carcinoma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}]",114.0,0.181336,"CMDF was associated with higher risk of NEC; relative risk (RR) 4.2 ( p = 0.038), NEC surgery or death (RR 5.1, p = 0.014); and reduced head circumference gain ( p = 0.04). ","[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Lucas', 'Affiliation': 'Institute of Child Health, University College, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boscardin', 'Affiliation': 'Department of Medicine and University of California, San Francisco, California, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Abrams', 'Affiliation': 'Department of Pediatrics, Dell Medical School, The University of Texas, Austin, Texas, USA.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2019.0133']
338,32228462,Couple-based collaborative management model of type 2 diabetes mellitus for community-dwelling older adults in China: protocol for a hybrid type 1 randomized controlled trial.,"BACKGROUND
China's limited health care resources cannot meet the needs of chronic disease treatment and management of its rapid growing ageing population. The improvement and maintenance of patient's self-management is essential to disease management. Given disease management mainly occurs in the context of family, this study proposes to validate a Couple-based Collaborative Management Model of chronic diseases that integrates health professionals and family supporters; such as to empower the couples with disease management knowledge and skills, and to improve the couples' health and quality of life.
METHODS
The proposed study will validate a couple-based collaborative management model of Type 2 Diabetes Mellitus (T2DM) in a community-based multicenter, two-arm, randomized controlled trial of block design in Guangzhou, China. Specifically, 194 T2DM patients aged ≥55 and their partners recruited from community health care centers will be randomized at the patient level for each center at a 1:1 ratio into the couple-based intervention arm and the individual-based control arm. For the intervention arm, both the patients and their spouses will receive four-weekly structured group education & training sessions and 2 months of weekly tailored behavior change boosters; while these interventions will be only provided to the patients in the control group. Behavior change incentives will be targeted at the couples or only at the patient respectively. Treatment effects on patients' hemoglobin, spouses' quality of life, alongside couples' behavior outcomes will be compared between arms. Study implementation will be evaluated considering its Reach, Effectiveness, Adoption, Implementation and Maintenance following the RE-AIM framework.
DISCUSSION
This study will generate a model of effective collaboration between community health professionals and patients' family, which will shield light on chronic disease management strategy for the increasing ageing population.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, ChiCTR1900027137, Registered 1st Nov. 2019.",2020,"Treatment effects on patients' hemoglobin, spouses' quality of life, alongside couples' behavior outcomes will be compared between arms.","['Type 2 Diabetes Mellitus (T2DM) in a community-based multicenter', '194 T2DM patients aged ≥55 and their partners recruited from community health care centers', 'type 2 diabetes mellitus for community-dwelling older adults in China']",['Couple-based collaborative management model'],[],"[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086034', 'cui_str': 'Community Health Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",[],194.0,0.0639039,"Treatment effects on patients' hemoglobin, spouses' quality of life, alongside couples' behavior outcomes will be compared between arms.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Medical Statistics & Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, P.R. China.'}, {'ForeName': 'Xueji', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Division of Primary Health Care, Guangzhou Center for Disease Control and Prevention, Guangzhou, P.R. China.'}, {'ForeName': 'Caixuan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Statistics & Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, P.R. China.'}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'School of Nursing, Sun Yat-sen University, Guangzhou, P.R. China.'}, {'ForeName': 'Yiyuan', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Medical Statistics & Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, P.R. China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Statistics & Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, P.R. China.'}, {'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Statistics & Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, P.R. China.'}, {'ForeName': 'Xiongfei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Division of Primary Health Care, Guangzhou Center for Disease Control and Prevention, Guangzhou, P.R. China.'}, {'ForeName': 'Shaolong', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Health Policy and Management, School of Public Health, Sun Yat-sen University, Guangzhou, P.R. China.'}, {'ForeName': 'Yung Jen', 'Initials': 'YJ', 'LastName': 'Yang', 'Affiliation': 'Taiwanese Society of Geriatric Psychiatry, Taiwan, China.'}, {'ForeName': 'Dong Roman', 'Initials': 'DR', 'LastName': 'Xu', 'Affiliation': 'Sun Yat-sen Global Health Institute, School of Public Health and Institute of State Governance, Sun Yat-sen University, No.135 Xingang West Road, Guangzhou, 510275, P.R. China. xudong5@mail.sysu.edu.cn.'}]",BMC geriatrics,['10.1186/s12877-020-01528-5']
339,32228468,"Gait speed, cognition and falls in people living with mild-to-moderate Alzheimer disease: data from NILVAD.","BACKGROUND
Previous evidence suggests that slower gait speed is longitudinally associated with cognitive impairment, dementia and falls in older adults. Despite this, the longitudinal relationship between gait speed, cognition and falls in those with a diagnosis of dementia remains poorly explored. We sought to assess this longitudinal relationship in a cohort of older adults with mild to-moderate Alzheimer Disease (AD).
METHODS
Analysis of data from NILVAD, an 18-month randomised-controlled trial of Nilvadipine in mild to moderate AD. We examined: (i) the cross-sectional (baseline) association between slow gait speed and cognitive function, (ii) the relationship between baseline slow gait speed and cognitive function at 18 months (Alzheimer Disease Assessment Scale, Cognitive Subsection: ADAS-Cog), (iii) the relationship between baseline cognitive function and incident slow gait speed at 18 months and finally (iv) the relationship of baseline slow gait speed and incident falls over the study period.
RESULTS
Overall, one-tenth (10.03%, N = 37/369) of participants with mild-to-moderate AD met criteria for slow gait speed at baseline and a further 14.09% (N = 52/369) developed incident slow gait speed at 18 months. At baseline, there was a significant association between poorer cognition and slow gait speed (OR 1.05, 95% CI 1.01-1.09, p = 0.025). Whilst there was no association between baseline slow gait speed and change in ADAS-Cog score at 18 months, a greater cognitive severity at baseline predicted incident slow gait speed over 18 months (OR 1.04, 1.01-1.08, p = 0.011). Further, slow gait speed at baseline was associated with a significant risk of incident falls over the study period, which persisted after covariate adjustment (IRR 3.48, 2.05-5.92, p < 0.001).
CONCLUSIONS
Poorer baseline cognition was associated with both baseline and incident slow gait speed. Slow gait speed was associated with a significantly increased risk of falls over the study period. Our study adds further evidence to the complex relationship between gait and cognition in this vulnerable group and highlights increased falls risk in older adults with AD and slow gait speed.
TRIAL REGISTRATION
Secondary analysis of the NILVAD trial (Clincaltrials.gov NCT02017340; EudraCT number 2012-002764-27). First registered: 20/12/2013.",2020,Whilst there was no association between baseline slow gait speed and change in ADAS,"['older adults', 'older adults with AD and slow gait speed', 'older adults with mild to-moderate Alzheimer Disease (AD', 'people living with mild-to-moderate Alzheimer disease', 'mild to moderate AD']",['Nilvadipine'],"['slow gait speed and cognitive function, (ii) the relationship between baseline slow gait speed and cognitive function at 18\u2009months (Alzheimer Disease Assessment Scale, Cognitive Subsection: ADAS-Cog), (iii) the relationship between baseline cognitive function and incident slow gait speed at 18\u2009months and finally (iv) the relationship of baseline slow gait speed and incident falls', 'Gait speed, cognition and falls', 'baseline slow gait speed and change in ADAS', 'risk of falls', 'cognitive severity', 'Slow gait speed', 'poorer cognition and slow gait speed', 'incident slow gait speed', 'Cog score', 'slow gait speed']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}]","[{'cui': 'C0132512', 'cui_str': 'nilvadipine'}]","[{'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.170148,Whilst there was no association between baseline slow gait speed and change in ADAS,"[{'ForeName': 'Adam H', 'Initials': 'AH', 'LastName': 'Dyer', 'Affiliation': 'Department of Age-Related Healthcare, Tallaght University Hospital, Dublin, Ireland. dyera@tcd.ie.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lawlor', 'Affiliation': 'Department of Medical Gerontology, School of Medicine, Trinity College Dublin, Dublin 2, Ireland.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Kennelly', 'Affiliation': 'Department of Age-Related Healthcare, Tallaght University Hospital, Dublin, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC geriatrics,['10.1186/s12877-020-01531-w']
340,31586540,Double J stent removal in paediatric patients by Vellore Catheter Snare technique: a randomised control trial.,"BACKGROUND
Double J (DJ) stents placed at the end of paediatric urological procedures require another cystoscopy under general anaesthesia for removal. The second author developed a reproducible technique for snaring the DJ stent using an infant feeding tube (6-Fr or 8-Fr) and a 3-0 polypropylene suture per urethra. Having demonstrated the proof of concept, ethical clearance was obtained for an institutional randomised controlled trial.
OBJECTIVE
The aim of the study was (1) to describe the Vellore Catheter Snare (VeCS) technique for DJ stent removal, (2) to study the efficacy of the technique and (3) to compare the costs of VeCS technique with cystoscopy on an intention-to-treat basis.
STUDY DESIGN
The study design was that of a randomised control trial with parallel groups as a non-inferiority study.
RESULTS
Forty children with unilateral indwelling DJ stents were enrolled from January to August 2018. They were randomised by unequal allocation (1:3) to cystoscopic and VeCS technique removal arms. The VeCS technique and cystoscopy were successful in 86.67% (26/30) and in 100% (10/10) cases, respectively, with no statistically significant difference in the outcome (p = 0.223). The average cost for cystoscopic removal of the stent was INR 14,579 and was INR 5636.5 for the VeCS technique (on an intention-to-treat basis).
DISCUSSION
While per-urethral catheterisation is an outpatient/ward procedure in children, cystoscopy is not. Other techniques such as extraction strings and magnetic stents with their extraction device were found to have certain disadvantages. The VeCS technique, using common disposables, circumvented the need for inpatient admission, disinfected equipment usage and operation theatre time in 87% children, thereby reducing the costs incurred by the patient.
CONCLUSION
The VeCS technique for DJ stent removal is a practical low-cost safe alternative to cystoscopic removal of DJ stents in children. Although the technique has a high success rate, it still needs the backup option of cystoscopy under general anaesthesia.",2019,The VeCS technique for DJ stent removal is a practical low-cost safe alternative to cystoscopic removal of DJ stents in children.,"['Forty children with unilateral indwelling DJ stents were enrolled from January to August 2018', 'paediatric patients by Vellore Catheter Snare technique']","['VeCS technique with cystoscopy', 'Vellore Catheter Snare (VeCS) technique', 'Double J stent removal']",['average cost for cystoscopic removal'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0439848', 'cui_str': 'Indwelling (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0183362', 'cui_str': 'Snare, device (physical object)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0183362', 'cui_str': 'Snare, device (physical object)'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent (physical object)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]",40.0,0.0920224,The VeCS technique for DJ stent removal is a practical low-cost safe alternative to cystoscopic removal of DJ stents in children.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sundaramurthy', 'Affiliation': 'Department of Pediatric Surgery, Christian Medical College, Vellore, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Joseph Thomas', 'Affiliation': 'Department of Pediatric Surgery, Christian Medical College, Vellore, India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Herle', 'Affiliation': 'Department of Pediatric Surgery, Christian Medical College, Vellore, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Jeyaseelan', 'Affiliation': 'Department of Pediatric Surgery, Christian Medical College, Vellore, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mathai', 'Affiliation': 'Department of Pediatric Surgery, Christian Medical College, Vellore, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jacob Kurian', 'Affiliation': 'Department of Pediatric Surgery, Christian Medical College, Vellore, India. Electronic address: paedsur@cmcvellore.ac.in.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2019.08.009']
341,32187403,Carbohydrates do not accelerate force recovery after glycogen-depleting followed by high-intensity exercise in humans.,"Prolonged low-frequency force depression (PLFFD) induced by fatiguing exercise is characterized by a persistent depression in submaximal contractile force during the recovery period. Muscle glycogen depletion is known to limit physical performance during prolonged low- and moderate-intensity exercise, and accelerating glycogen resynthesis with post-exercise carbohydrate intake can facilitate recovery and improve repeated bout exercise performance. Short-term, high-intensity exercise, however, can cause PLFFD without any marked decrease in glycogen. Here, we studied whether recovery from PLFFD was accelerated by carbohydrate ingestion after 60 minutes of moderate-intensity glycogen-depleting cycling exercise followed by six 30-seconds all-out cycling sprints. We used a randomized crossover study design where nine recreationally active males drank a beverage containing either carbohydrate or placebo after exercise. Blood glucose and muscle glycogen concentrations were determined at baseline, immediately post-exercise, and during the 3-hours recovery period. Transcutaneous electrical stimulation of the quadriceps muscle was performed to determine the extent of PLFFD by eliciting low-frequency (20 Hz) and high-frequency (100 Hz) stimulations. Muscle glycogen was severely depleted after exercise, with a significantly higher rate of muscle glycogen resynthesis during the 3-hours recovery period in the carbohydrate than in the placebo trials (13.7 and 5.4 mmol glucosyl units/kg wet weight/h, respectively). Torque at 20 Hz was significantly more depressed than 100 Hz torque during the recovery period in both conditions, and the extent of PLFFD (20/100 Hz ratio) was not different between the two trials. In conclusion, carbohydrate supplementation enhances glycogen resynthesis after glycogen-depleting exercise but does not improve force recovery when the exercise also involves all-out cycling sprints.",2020,"Torque at 20Hz was significantly more depressed than 100 Hz torque during the recovery period in both conditions, and the extent of PLFFD (20/100Hz ratio) was not different between the two trials.",['nine recreationally-active males drank a beverage containing either'],"['carbohydrate or placebo', 'placebo', 'carbohydrate supplementation']","['Torque at 20Hz', 'PLFFD by eliciting low-frequency (20Hz) and high-frequency (100Hz) stimulations', 'glycogen', 'Blood glucose and muscle glycogen concentrations', 'Muscle glycogen', 'rate of muscle glycogen re-synthesis']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3538953', 'cui_str': 'Carbohydrate supplementation'}]","[{'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.125912,"Torque at 20Hz was significantly more depressed than 100 Hz torque during the recovery period in both conditions, and the extent of PLFFD (20/100Hz ratio) was not different between the two trials.","[{'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'Cheng', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chaillou', 'Affiliation': 'School of Health Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Sigitas', 'Initials': 'S', 'LastName': 'Kamandulis', 'Affiliation': 'Sports Science and Innovation Institute, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Andrejus', 'Initials': 'A', 'LastName': 'Subocius', 'Affiliation': 'Sports Science and Innovation Institute, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Westerblad', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Brazaitis', 'Affiliation': 'Sports Science and Innovation Institute, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Venckunas', 'Affiliation': 'Sports Science and Innovation Institute, Lithuanian Sports University, Kaunas, Lithuania.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13655']
342,24103895,Safety and infectivity of two doses of live-attenuated recombinant cold-passaged human parainfluenza type 3 virus vaccine rHPIV3cp45 in HPIV3-seronegative young children.,"BACKGROUND
Human parainfluenza virus type 3 (HPIV3) is a common cause of upper and lower respiratory tract illness in infants and young children. Live-attenuated cold-adapted HPIV3 vaccines have been evaluated in infants but a suitable interval for administration of a second dose of vaccine has not been defined.
METHODS
HPIV3-seronegative children between the ages of 6 and 36 months were randomized 2:1 in a blinded study to receive two doses of 10⁵ TCID₅₀ (50% tissue culture infectious dose) of live-attenuated, recombinant cold-passaged human PIV3 vaccine (rHPIV3cp45) or placebo 6 months apart. Serum antibody levels were assessed prior to and approximately 4-6 weeks after each dose. Vaccine virus infectivity, defined as detection of vaccine-HPIV3 in nasal wash and/or a≥4-fold rise in serum antibody titer, and reactogenicity were assessed on days 3, 7, and 14 following immunization.
RESULTS
Forty HPIV3-seronegative children (median age 13 months; range 6-35 months) were enrolled; 27 (68%) received vaccine and 13 (32%) received placebo. Infectivity was detected in 25 (96%) of 26 evaluable vaccinees following doses 1 and 9 of 26 subject (35%) following dose 2. Among those who shed virus, the median duration of viral shedding was 12 days (range 6-15 days) after dose 1 and 6 days (range 3-8 days) after dose 2, with a mean peak log₁₀ viral titer of 3.4 PFU/mL (SD: 1.0) after dose 1 compared to 1.5 PFU/mL (SD: 0.92) after dose 2. Overall, reactogenicity was mild, with no difference in rates of fever and upper respiratory infection symptoms between vaccine and placebo groups.
CONCLUSION
rHPIV3cp45 was immunogenic and well-tolerated in seronegative young children. A second dose administered 6 months after the initial dose was restricted in those previously infected with vaccine virus; however, the second dose boosted antibody responses and induced antibody responses in two previously uninfected children.",2013,"Overall, reactogenicity was mild, with no difference in rates of fever and upper respiratory infection symptoms between vaccine and placebo groups.
","['HPIV3-seronegative children between the ages of 6 and 36 months', 'seronegative young children', 'infants and young children', 'HPIV3-seronegative young children', 'Forty HPIV3-seronegative children (median age 13 months; range 6-35 months) were enrolled; 27 (68%) received']","['Live-attenuated cold-adapted HPIV3 vaccines', 'placebo', 'rHPIV3cp45', 'vaccine', 'TCID₅₀ (50% tissue culture infectious dose) of live-attenuated, recombinant cold-passaged human PIV3 vaccine (rHPIV3cp45) or placebo', 'live-attenuated recombinant cold-passaged human parainfluenza type 3 virus vaccine rHPIV3cp45']","['Serum antibody levels', 'Infectivity', 'rates of fever and upper respiratory infection symptoms', 'serum antibody titer, and reactogenicity', 'median duration of viral shedding']","[{'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040284', 'cui_str': 'Tissue culture (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030389', 'cui_str': 'Parainfluenza'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0042776', 'cui_str': 'Virus'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030657', 'cui_str': 'infectivity'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}]",40.0,0.306514,"Overall, reactogenicity was mild, with no difference in rates of fever and upper respiratory infection symptoms between vaccine and placebo groups.
","[{'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Englund', 'Affiliation': ""Seattle Children's Hospital, University of Washington, 4800 Sand Point Way NE, Seattle, WA 98105, United States. Electronic address: janet.englund@seattlechildrens.org.""}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Karron', 'Affiliation': ''}, {'ForeName': 'Coleen K', 'Initials': 'CK', 'LastName': 'Cunningham', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Larussa', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Melvin', 'Affiliation': ''}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Yogev', 'Affiliation': ''}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Handelsman', 'Affiliation': ''}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Siberry', 'Affiliation': ''}, {'ForeName': 'Bhavanji', 'Initials': 'B', 'LastName': 'Thumar', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schappell', 'Affiliation': ''}, {'ForeName': 'Catherine V', 'Initials': 'CV', 'LastName': 'Bull', 'Affiliation': ''}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schaap-Nutt', 'Affiliation': ''}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Buchholz', 'Affiliation': ''}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2013.09.046']
343,32238338,Optimizing Text Messages to Promote Engagement With Internet Smoking Cessation Treatment: Results From a Factorial Screening Experiment.,"BACKGROUND
Smoking remains a leading cause of preventable death and illness. Internet interventions for smoking cessation have the potential to significantly impact public health, given their broad reach and proven effectiveness. Given the dose-response association between engagement and behavior change, identifying strategies to promote engagement is a priority across digital health interventions. Text messaging is a proven smoking cessation treatment modality and a powerful strategy to increase intervention engagement in other areas of health, but it has not been tested as an engagement strategy for a digital cessation intervention.
OBJECTIVE
This study examined the impact of 4 experimental text message design factors on adult smokers' engagement with an internet smoking cessation program.
METHODS
We conducted a 2×2×2×2 full factorial screening experiment wherein 864 participants were randomized to 1 of 16 experimental conditions after registering with a free internet smoking cessation program and enrolling in its automated text message program. Experimental factors were personalization (on/off), integration between the web and text message platforms (on/off), dynamic tailoring of intervention content based on user engagement (on/off), and message intensity (tapered vs abrupt drop-off). Primary outcomes were 3-month measures of engagement (ie, page views, time on site, and return visits to the website) as well as use of 6 interactive features of the internet program. All metrics were automatically tracked; there were no missing data.
RESULTS
Main effects were detected for integration and dynamic tailoring. Integration significantly increased interactive feature use by participants, whereas dynamic tailoring increased the number of features used and page views. No main effects were found for message intensity or personalization alone, although several synergistic interactions with other experimental features were observed. Synergistic effects, when all experimental factors were active, resulted in the highest rates of interactive feature use and the greatest proportion of participants at high levels of engagement. Measured in terms of standardized mean differences (SMDs), effects on interactive feature use were highest for Build Support System (SMD 0.56; 95% CI 0.27 to 0.81), Choose Quit Smoking Aid (SMD 0.38; 95% CI 0.10 to 0.66), and Track Smoking Triggers (SMD 0.33; 95% CI 0.05 to 0.61). Among the engagement metrics, the largest effects were on overall feature utilization (SMD 0.33; 95% CI 0.06 to 0.59) and time on site (SMD 0.29; 95% CI 0.01 to 0.57). As no SMD >0.30 was observed for main effects on any outcome, results suggest that for some outcomes, the combined intervention was stronger than individual factors alone.
CONCLUSIONS
This factorial experiment demonstrates the effectiveness of text messaging as a strategy to increase engagement with an internet smoking cessation intervention, resulting in greater overall intervention dose and greater exposure to the core components of tobacco dependence treatment that can promote abstinence.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02585206; https://clinicaltrials.gov/ct2/show/NCT02585206.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.1136/bmjopen-2015-010687.",2020,"No main effects were found for message intensity or personalization alone, although several synergistic interactions with other experimental features were observed.","[""adult smokers' engagement with an internet smoking cessation program"", '864 participants were randomized to 1 of 16 experimental conditions after registering with a']",['free internet smoking cessation program and enrolling in its automated text message program'],"['3-month measures of engagement (ie, page views, time on site, and return visits to the website) as well as use of 6 interactive features of the internet program', 'Synergistic effects', 'Choose Quit Smoking Aid', 'overall feature utilization', 'Track Smoking Triggers']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]",864.0,0.0987372,"No main effects were found for message intensity or personalization alone, although several synergistic interactions with other experimental features were observed.","[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Graham', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, United States.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Papandonatos', 'Affiliation': 'Center for Statistical Sciences, Brown University, Providence, RI, United States.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Jacobs', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, United States.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Amato', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cha', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, United States.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Cohn', 'Affiliation': 'Oklahoma Tobacco Research Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.'}, {'ForeName': 'Lorien C', 'Initials': 'LC', 'LastName': 'Abroms', 'Affiliation': 'Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington, DC, United States.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Whittaker', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Auckland, New Zealand.'}]",Journal of medical Internet research,['10.2196/17734']
344,31237459,Effects of the Values and Options in Cancer Care Communication Intervention on Personal Caregiver Experiences of Cancer Care and Bereavement Outcomes.,"Background: Care teams are increasingly expected to attend to the needs of patient's personal caregivers (e.g., family members). Improving communication among oncologists, patients with advanced cancer, and their personal caregivers might enhance caregivers' experiences of end-of-life (EoL) cancer care and bereavement outcomes. Objective: To explore the effects of the Values and Options in Cancer Care intervention on caregivers' experiences of EoL care and bereavement outcomes. Design : We developed a brief behavioral intervention to improve communication among oncologists, patients with advanced cancer, and their personal caregivers. The intervention was designed to help patients/caregivers ask questions, express concerns, and help oncologists respond effectively. We randomly assigned oncologists (and their patients/caregivers) to the intervention or usual care. Setting/Subjects: Medical oncologists in NY and CA; patients/personal caregivers with advanced cancer. Measurements: Two months after the patient's death, caregivers completed three instruments assessing their experiences of EoL care. Seven months after the patient's death, caregivers completed the Prolonged Grief Disorder-13 (PG-13; primary prespecified outcome), the Purpose-in-Life scale, and scales assessing mental health function, depression, and anxiety. Results : The intervention did not significantly improve caregivers' scores on the PG-13 ( p = 0.21), mental health function, depression, or anxiety, but it did improve purpose-in-life scores ( p = 0.018). Cohen's d (95% confidence interval) for all three experiences of EoL care outcomes were promising, ranging from 0.22 (-0.19 to 0.63) to 0.39 (-0.07 to 0.86) although none was statistically significant. Conclusion: Preliminary findings show promise that scalable interventions in cancer care settings may improve caregiver experiences with cancer care and some bereavement outcomes.",2019,"The intervention did not significantly improve caregivers' scores on the PG-13 ( p = 0.21), mental health function, depression, or anxiety, but it did improve purpose-in-life scores ( p = 0.018).","['Setting/Subjects: Medical oncologists in NY and CA; patients/personal caregivers with advanced cancer', 'patients with advanced cancer, and their personal caregivers']","['Cancer Care Communication Intervention', 'Cancer Care intervention', 'intervention or usual care', 'behavioral intervention']","['Prolonged Grief Disorder-13', 'purpose-in-life scores', 'death', 'Purpose-in-Life scale, and scales assessing mental health function, depression, and anxiety', 'Personal Caregiver Experiences of Cancer Care and Bereavement Outcomes', ""caregivers' scores"", 'mental health function, depression, or anxiety']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1555767', 'cui_str': 'Medical oncologist (occupation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}]","[{'cui': 'C4511668', 'cui_str': 'Prolonged grief disorder (finding)'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0222045'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1879338', 'cui_str': 'Bereavement due to life event (finding)'}]",,0.0426869,"The intervention did not significantly improve caregivers' scores on the PG-13 ( p = 0.21), mental health function, depression, or anxiety, but it did improve purpose-in-life scores ( p = 0.018).","[{'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Duberstein', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Maciejewski', 'Affiliation': 'Department of Radiology, Department of Medicine, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Fenton', 'Affiliation': 'Department of Family and Community Medicine, University of California, Davis, Sacramento, California.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Chapman', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Norton', 'Affiliation': 'Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoerger', 'Affiliation': 'Tulane Cancer Center, Tulane University, New Orleans, Louisiana.'}, {'ForeName': 'Marsha N', 'Initials': 'MN', 'LastName': 'Wittink', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tancredi', 'Affiliation': 'Center for Healthcare Policy and Research, University of California, Davis, Sacramento, California.'}, {'ForeName': 'Guibo', 'Initials': 'G', 'LastName': 'Xing', 'Affiliation': 'Center for Healthcare Policy and Research, University of California, Davis, Sacramento, California.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Mohile', 'Affiliation': 'James P Wilmot Cancer Center, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Kravitz', 'Affiliation': 'UC Davis Comprehensive Cancer Center, University of California, Davis, Sacramento, California.'}, {'ForeName': 'Holly G', 'Initials': 'HG', 'LastName': 'Prigerson', 'Affiliation': 'Cornell Center for Research on End-of-Life Care, Department of Medicine, Weill Cornell Medical College, New York, New York.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0078']
345,31685489,Effect of Surgical Versus Medical Therapy on Diabetic Kidney Disease Over 5 Years in Severely Obese Adolescents With Type 2 Diabetes.,"OBJECTIVE
To compare diabetic kidney disease (DKD) rates over 5 years of follow-up in two cohorts of severely obese adolescents with type 2 diabetes (T2D) undergoing medical or surgical treatment for T2D.
RESEARCH DESIGN AND METHODS
A secondary analysis was performed of data collected from obese participants of similar age and racial distribution enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and the Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) studies. Teen-LABS participants underwent metabolic bariatric surgery (MBS). TODAY participants were randomized to metformin alone or in combination with rosiglitazone or intensive lifestyle intervention, with insulin therapy given for glycemic progression. Glycemic control, BMI, estimated glomerular filtration rate (eGFR), urinary albumin excretion (UAE), and prevalence of hyperfiltration (eGFR ≥135 mL/min/1.73 m 2 ) and elevated UAE (≥30 mg/g) were assessed annually.
RESULTS
Participants with T2D from Teen-LABS ( n = 30, mean ± SD age, 16.9 ± 1.3 years; 70% female; 60% white; BMI 54.4 ± 9.5 kg/m 2 ) and TODAY ( n = 63, age 15.3 ± 1.3 years; 56% female; 71% white; BMI 40.5 ± 4.9 kg/m 2 ) were compared. During 5 years of follow-up, hyperfiltration decreased from 21% to 18% in Teen-LABS and increased from 7% to 48% in TODAY. Elevated UAE decreased from 27% to 5% in Teen-LABS and increased from 21% to 43% in TODAY. Adjusting for baseline age, sex, BMI, and HbA 1c , TODAY participants had a greater odds of hyperfiltration (odds ratio 15.7 [95% CI 2.6, 94.3]) and elevated UAE (27.3 [4.9, 149.9]) at 5 years of follow-up.
CONCLUSIONS
Compared with MBS, medical treatment of obese youth with T2D was associated with a higher odds of DKD over 5 years.",2020,"Compared with MBS, medical treatment of obese youth with T2D was associated with a higher odds of DKD over 5 years.","['Participants with T2D from Teen-LABS ( n = 30, mean ± SD age, 16.9 ± 1.3 years; 70% female; 60% white; BMI 54.4 ± 9.5 kg/m 2 ) and TODAY ( n = 63, age 15.3 ± 1.3 years; 56% female; 71% white; BMI 40.5 ± 4.9 kg/m 2 ', 'Diabetic Kidney Disease Over 5 Years in Severely Obese Adolescents With Type 2 Diabetes', 'severely obese adolescents with type 2 diabetes ', 'T2D) undergoing medical or surgical treatment for T2D', 'obese participants of similar age and racial distribution enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and the Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) studies']","['Surgical Versus Medical Therapy', 'metabolic bariatric surgery (MBS', 'metformin alone or in combination with rosiglitazone or intensive lifestyle intervention, with insulin therapy']","['Elevated UAE', 'Glycemic control, BMI, estimated glomerular filtration rate (eGFR), urinary albumin excretion (UAE), and prevalence of hyperfiltration (eGFR ≥135 mL/min/1.73 m 2 ) and elevated UAE', 'diabetic kidney disease (DKD) rates']","[{'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]",,0.0493397,"Compared with MBS, medical treatment of obese youth with T2D was associated with a higher odds of DKD over 5 years.","[{'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Bjornstad', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO petter.bjornstad@childrenscolorado.org.""}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Hughan', 'Affiliation': ""University of Pittsburgh and UPMC Children's Hospital Pittsburgh, Pittsburgh, PA.""}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Kelsey', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Nehus', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mitsnefes', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Jenkins', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Inge', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Nadeau', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}]",Diabetes care,['10.2337/dc19-0708']
346,30952941,Effect of ranolazine on plasma arginine derivatives and urinary isoprostane 8-iso-PGF 2α in patients with myocardial infarction in the randomized RIMINI-Trial.,"The purpose of the present study was to assess whether 6-week ranolazine application on top of guideline-based treatment impacts on the arginine/NO pathway and urinary isoprostane 8-iso-PGF 2α as marker of oxidative stress in patients directly after a myocardial infarction. 20 patients with unstable angina pectoris and proof of acute cardiac ischemia entered the study. 10 subjects received the study drug ranolazine in addition to standard treatment, the others received only standard treatment. Urine and venous blood were collected before and after treatment. At the end of the study and compared to baseline, homoarginine levels had increased in the control group. This was not the case in ranolazine-patients. Interestingly, in ranolazine-treated-patients arginine plasma levels were significantly higher at the end of the study than at baseline (difference +26 µmol/L, 95% CI 8.6 to 44 µmol/L). ADMA and SDMA levels were not different. Urine levels of the oxidative stress marker 8-iso-PGF 2α tended to be lower in ranolazine-treated patients (-144 pmol/mg creatinine). Findings of this hypothesis-driven study give evidence that ranolazine treatment enhances arginine plasma levels and lowers oxidative stress.",2019,Urine levels of the oxidative stress marker 8-iso-PGF 2α tended to be lower in ranolazine-treated patients (-144 pmol/mg creatinine).,"['10 subjects', '20 patients with unstable angina pectoris and proof of acute cardiac ischemia entered the study', 'patients directly after a myocardial infarction', 'patients with myocardial infarction']",['ranolazine'],"['oxidative stress', 'plasma arginine derivatives', 'Urine and venous blood', 'arginine plasma levels', 'arginine plasma levels and lowers oxidative stress', 'ADMA and SDMA levels', 'homoarginine levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C0073633', 'cui_str': 'ranolazine'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0042037'}, {'cui': 'C0229667', 'cui_str': 'VB - Venous blood'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0019877', 'cui_str': 'L-Lysine, N(6)-(aminoiminomethyl)-'}]",20.0,0.0304864,Urine levels of the oxidative stress marker 8-iso-PGF 2α tended to be lower in ranolazine-treated patients (-144 pmol/mg creatinine).,"[{'ForeName': 'Tjark F', 'Initials': 'TF', 'LastName': 'Schwemer', 'Affiliation': 'University Heart Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Navina', 'Initials': 'N', 'LastName': 'Deutscher', 'Affiliation': 'University Heart Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Diermann', 'Affiliation': 'University Heart Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Böger', 'Affiliation': 'Institute of Experimental Pharmacology and Toxicology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Edzard', 'Initials': 'E', 'LastName': 'Schwedhelm', 'Affiliation': 'Institute of Experimental Pharmacology and Toxicology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Blankenberg', 'Affiliation': 'DZHK (German Centre for Cardiovascular Research), partner site Hamburg/Kiel/Lübeck, Hamburg, Germany.'}, {'ForeName': 'Felix W', 'Initials': 'FW', 'LastName': 'Friedrich', 'Affiliation': 'Institute of Experimental Pharmacology and Toxicology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. f.friedrich@uke.de.'}]",Scientific reports,['10.1038/s41598-019-42239-1']
347,32241810,Economic evaluation alongside the Speed of Increasing milk Feeds Trial (SIFT).,"OBJECTIVE
To evaluate the cost-effectiveness of two rates of enteral feed advancement (18 vs 30 mL/kg/day) in very preterm and very low birth weight infants.
DESIGN
Within-trial economic evaluation alongside a multicentre, two-arm parallel group, randomised controlled trial (Speed of Increasing milk Feeds Trial).
SETTING
55 UK neonatal units from May 2013 to June 2015.
PATIENTS
Infants born <32 weeks' gestation or <1500 g, receiving less than 30 mL/kg/day of milk at trial enrolment. Infants with a known severe congenital anomaly, no realistic chance of survival, or unlikely to be traceable for follow-up, were ineligible.
INTERVENTIONS
When clinicians were ready to start advancing feed volumes, infants were randomised to receive daily increments in feed volume of 30 mL/kg (intervention) or 18 mL/kg (control).
MAIN OUTCOME MEASURE
Cost per additional survivor without moderate to severe neurodevelopmental disability at 24 months of age corrected for prematurity.
RESULTS
Average costs per infant were slightly higher for faster feeds compared with slower feeds (mean difference £267, 95% CI -6928 to 8117). Fewer infants achieved the principal outcome of survival without moderate to severe neurodevelopmental disability at 24 months in the faster feeds arm (802/1224 vs 848/1246). The stochastic cost-effectiveness analysis showed a likelihood of worse outcomes for faster feeds compared with slower feeds.
CONCLUSIONS
The stochastic cost-effectiveness analysis shows faster feeds are broadly equivalent on cost grounds. However, in terms of outcomes at 24 months age (corrected for prematurity), faster feeds are harmful. Faster feeds should not be recommended on either cost or effectiveness grounds to achieve the primary outcome.",2020,Fewer infants achieved the principal outcome of survival without moderate to severe neurodevelopmental disability at 24 months in the faster feeds arm (802/1224 vs 848/1246).,"[""Infants born <32 weeks' gestation or <1500 g, receiving less than 30 mL/kg/day of milk at trial enrolment"", 'Infants with a known severe congenital anomaly, no realistic chance of survival, or unlikely to be traceable for follow-up, were ineligible', 'very preterm and very low birth weight infants', '55 UK neonatal units from May 2013 to June 2015']",['enteral feed advancement'],"['cost-effectiveness', 'survival without moderate to severe neurodevelopmental disability', 'Cost per additional survivor without moderate to severe neurodevelopmental disability']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1532579', 'cui_str': 'mL/kg/day'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",,0.240684,Fewer infants achieved the principal outcome of survival without moderate to severe neurodevelopmental disability at 24 months in the faster feeds arm (802/1224 vs 848/1246).,"[{'ForeName': 'Warda', 'Initials': 'W', 'LastName': 'Tahir', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Monahan', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Dorling', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Dalhousie University-Faculty of Medicine, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Hewer', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Bowler', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': 'National Perinatal epidemiology Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Partlett', 'Affiliation': 'Faculty of Medicine & Health Sciences, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Janet Elizabeth', 'Initials': 'JE', 'LastName': 'Berrington', 'Affiliation': 'Neonatology, Royal Victoria Infirmary, Newcastle upon Tyne, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Boyle', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Embleton', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Leaf', 'Affiliation': 'Neonatal Medicine, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Kenny', 'Initials': 'K', 'LastName': 'McCormick', 'Affiliation': 'John Radcliffe Hospital, Oxford, Oxfordshire, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'McGuire', 'Affiliation': 'Centre for Reviews and Dissemination, University of York, York, North Yorkshire, UK.'}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Stenson', 'Affiliation': 'Neonatology, Neonatal Unit, Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Roberts', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK t.e.roberts@bham.ac.uk.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-318346']
348,31853772,Use of Rapid HIV Self-Test to Screen Potential Sexual Partners: Results of the ISUM Study.,"ISUM (""I'll show you mine"") was a randomized controlled trial in which 272 transgender women and men who have sex with men in New York, NY (NYC) and San Juan, Puerto Rico (SJU) were assigned to an intervention group (n = 136), in which they had access to free HIV self-testing (ST) kits, or to a control group (n = 136). The trial aimed to determine whether the intervention group would use ST to screen sexual partners and have fewer condomless anal intercourse (CAI) occasions with serodiscordant or unknown status partners than the control group. The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08). In NYC (n = 166) intervention participants had significantly fewer CAI occasions, whereas in SJU (n = 106) they reported non-significantly more CAI occasions. Two devastating hurricanes hit SJU during the study and may have impacted results in unmeasured ways.",2020,"The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08).","['Screen Potential Sexual Partners', 'to screen sexual partners and have fewer condomless anal intercourse (CAI) occasions with serodiscordant or unknown status partners than the control group', '272 transgender women and men who have sex with men in New York, NY (NYC) and San Juan, Puerto Rico (SJU']","['ST', 'ISUM (""I\'ll show you mine', 'Rapid HIV Self-Test']",['CAI occasions'],"[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",[],,0.0544861,"The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08).","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA. ac72@cumc.columbia.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Cheng-Shiun', 'Initials': 'CS', 'LastName': 'Leu', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez Rios', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Alan Z', 'Initials': 'AZ', 'LastName': 'Sheinfil', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Frasca', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Christine Tagliaferri', 'Initials': 'CT', 'LastName': 'Rael', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Iribarren', 'Affiliation': 'Biobehavioral Nursing and Health Informatics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cruz Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02763-7']
349,32236417,Predictors of Smoking Cessation Attempts and Success Following Motivation-Phase Interventions Among People Initially Unwilling to Quit Smoking.,"INTRODUCTION
Most people who smoke cigarettes are not willing (ie, not ready) to make a quit attempt (QA) at any given time. Unfortunately, interventions intended to increase QAs and the success of QAs are only modestly effective. Identifying processes leading to QAs and quitting success could guide intervention development.
AIMS AND METHODS
This is a secondary analysis of a randomized factorial trial of 6 weeks of motivation-phase interventions among primary care patients (N = 517) who were initially unwilling to quit but were willing to reduce their smoking. Using logistic regression, we controlled for treatment condition and tested whether baseline or change in smoking-related constructs after 6 weeks of treatment predicted (1) making an at least 24 h QA between weeks 6 and 26 and (2) quitting success at week 26 (7-day point-prevalence abstinence among those who made a QA). Predictors included cigarettes/day, time to first cigarette, motivation to quit, quitting self-efficacy, anticipated urges to smoke if quit, positive affect, negative affect, and time spent around others who smoke.
RESULTS
In multivariable models that included all smoking-related constructs, changes in the following variables predicted initiating a QA above and beyond other variables: greater baseline time to first cigarette (odds ratio [OR] = 1.60), increases in time to first cigarette (OR = 1.27), and increases in quitting self-efficacy (OR = 1.14). Increased motivation to quit predicted conversion of a QA into quitting success at 26 weeks (OR = 1.36).
CONCLUSION
Predictors of making a QA differed from predictors of quitting success. Predictors of QAs and success could each serve as important treatment targets of motivation-phase interventions.
IMPLICATIONS
Motivation-phase interventions for people initially unwilling to quit smoking cigarettes may be improved by striving to increase their (1) time to first cigarette and quitting self-efficacy to promote QAs and (2) motivation to quit to promote quit success. Future experimental tests of such interventions are needed to identify causal determinants of QAs and quitting success.",2020,"Increased motivation to quit predicted conversion of a QA into quitting success at 26 weeks (OR=1.36).
","['primary care patients (N=517) who were initially unwilling to quit but were willing to reduce their smoking', 'people initially unwilling to quit smoking']",['motivation-phase interventions'],"['time to first cigarette', 'quitting self-efficacy', 'cigarettes/day, time-to-first cigarette, motivation to quit, quitting self-efficacy, anticipated urges to smoke if quit, positive affect, negative affect, and time spent around others who smoke', 'quitting success']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0558080', 'cui_str': 'Unwilling'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.0615191,"Increased motivation to quit predicted conversion of a QA into quitting success at 26 weeks (OR=1.36).
","[{'ForeName': 'Elias M', 'Initials': 'EM', 'LastName': 'Klemperer', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, VT.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Mermelstein', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin Madison School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hughes', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, VT.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Fiore', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin Madison School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin Madison School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Schlam', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin Madison School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Jorenby', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin Madison School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Collins', 'Affiliation': 'Department of Human Development and Family Studies and Statistics, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Cook', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin Madison School of Medicine and Public Health, Madison, WI.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa051']
350,31086250,Effects of diaphragmatic myofascial release on gastroesophageal reflux disease: a preliminary randomized controlled trial.,"The purpose of this study is to investigate whether implementing a myofascial release (MFR) protocol designed to restore the myofascial properties of the diaphragm has any effect on the symptoms, quality of life, and consumption of proton pump inhibitors (PPI) drugs by patients with non-erosive gastroesophageal reflux disease (GERD). We randomized 30 patients with GERD into a MFR group or a sham group. Changes in symptomatology and quality of life were measured with the Reflux Disease Questionnaire and the Gastrointestinal Quality of Life Index. Need of PPIs was measured as the milligrams of drug intake over the 7 days prior to each assessment. All variables were assessed at baseline, one week and 4 weeks after the end of the treatment. At week 4, patients receiving MFR showed significant improvements in symptomatology (mean difference-1.1; 95% CI: -1.7 to -0.5), gastrointestinal quality of life (mean difference 18.1; 95% CI: 4.8 to 31.5), and PPIs use (mean difference-97 mg; 95% CI: -162 to -32), compared to the sham group. These preliminary findings indicate that the application of the MFR protocol we used in this study decreased the symptoms and PPIs usage and increased the quality of life of patients with non-erosive GERD up to four weeks after the end of the treatment.",2019,Changes in symptomatology and quality of life were measured with the Reflux Disease Questionnaire and the Gastrointestinal Quality of Life Index.,"['30 patients with GERD into a MFR group or a sham group', 'patients with non-erosive gastroesophageal reflux disease (GERD']","['diaphragmatic myofascial release', 'proton pump inhibitors']","['Reflux Disease Questionnaire and the Gastrointestinal Quality of Life Index', 'gastroesophageal reflux disease', 'quality of life', 'gastrointestinal quality of life', 'symptomatology and quality of life', 'symptomatology']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1264663', 'cui_str': 'Mass fraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0445143', 'cui_str': 'Non-erosive (qualifier value)'}]","[{'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release (regime/therapy)'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0034380'}]",30.0,0.0395616,Changes in symptomatology and quality of life were measured with the Reflux Disease Questionnaire and the Gastrointestinal Quality of Life Index.,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Martínez-Hurtado', 'Affiliation': 'Department of Physiotherapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Arguisuelas', 'Affiliation': 'Department of Physiotherapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Almela-Notari', 'Affiliation': 'Department of Gastroenterology, Hospital General de Castellón, Castellón, Spain.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Cortés', 'Affiliation': 'Department of Medicine, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Barrasa-Shaw', 'Affiliation': 'Department of Surgery, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Campos-González', 'Affiliation': 'Department of Medicine, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Lisón', 'Affiliation': 'Department of Medicine, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain. juanfran@uchceu.es.'}]",Scientific reports,['10.1038/s41598-019-43799-y']
351,32199736,A home-based exercise program focused on proprioception to reduce falls in frail and pre-frail community-dwelling older adults.,"Frailty and falls are closely associated with each other as well as with disability, hospitalization, and death. Exercise can reduce these risks in both robust and frail older people. This before-after, non-randomized intervention study assessed a one-year proprioception training program with individual daily home exercises in 564 community-dwelling people aged 70 years and over, with different frailty phenotypes. After the exercise program, we observed a moderate reduction in the mean number of falls, fear of falls, body mass index and body fat percentage in frail and pre-frail participants. These results suggest that a home proprioception program may be a viable alternative to complex multicomponent exercise programs in settings where these are not feasible, since home proprioception can reach a larger population at a lower cost, and it affords clear benefits.",2020,"After the exercise program, we observed a moderate reduction in the mean number of falls, fear of falls, body mass index and body fat percentage in frail and pre-frail participants.","['frail older people', 'frail and pre-frail community-dwelling older adults', '564 community-dwelling people aged 70 years and over, with different frailty phenotypes']","['home-based exercise program', 'proprioception training program with individual daily home exercises', 'Exercise']","['mean number of falls, fear of falls, body mass index and body fat percentage']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0575126', 'cui_str': 'Falls occurrence'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}]",564.0,0.0126978,"After the exercise program, we observed a moderate reduction in the mean number of falls, fear of falls, body mass index and body fat percentage in frail and pre-frail participants.","[{'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Pérez-Ros', 'Affiliation': 'Department of Nursing, Universidad Católica de Valencia San Vicente Mártir, 46007 Valencia, Spain; Frailty and Cognitive Impairment Research Group (FROG), University of Valencia, 46010 Valencia, Spain. Electronic address: pilar.perez@ucv.es.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Vila-Candel', 'Affiliation': 'Department of Nursing, Universidad Católica de Valencia San Vicente Mártir, 46007 Valencia, Spain; Department of Obstetrics and Gynaecology, Hospital Universitario de la Ribera, FISABIO. Crtra. Corbera km 1, 46600 Valencia, Spain; Department of Nursing, Faculty of Nursing and Podiatry, Universitat de València, Jaume Roig, s/n, 46010 Valencia, Spain.'}, {'ForeName': 'Francisco Miguel', 'Initials': 'FM', 'LastName': 'Martínez-Arnau', 'Affiliation': 'Department of Nursing, Universidad Católica de Valencia San Vicente Mártir, 46007 Valencia, Spain; Frailty and Cognitive Impairment Research Group (FROG), University of Valencia, 46010 Valencia, Spain; Department of Physiotherapy, Universitat de València, 46010 Valencia, Spain.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.01.017']
352,32182127,Modified Iliotibial Band Tenodesis Is Indicated to Correct Intraoperative Residual Pivot Shift After Anterior Cruciate Ligament Reconstruction Using an Autologous Hamstring Tendon Graft: A Prospective Randomized Controlled Trial.,"BACKGROUND
The indications for the addition of anterolateral soft tissue augmentation to anterior cruciate ligament (ACL) reconstruction and its effectiveness remain uncertain.
PURPOSE
To determine if modified iliotibial band tenodesis (MITBT) can improve clinical outcomes and reduce the recurrence of ACL ruptures when added to ACL reconstruction in patients with a residual pivot shift.
STUDY DESIGN
Randomized controlled trial; Level of evidence, 2.
METHODS
Patients with a primary ACL rupture satisfying the following inclusion criteria were enrolled: first ACL rupture, involved in pivoting sports, skeletally mature, no meniscal repair performed, and residual pivot shift relative to the contralateral uninjured knee immediately after ACL reconstruction. Patients were randomized to group A (no further surgery) or group B (MITBT added) and were followed up for 2 years. The patient-reported outcome (PRO) measures used were the International Knee Documentation Committee (IKDC) score, Knee injury and Osteoarthritis Outcome Score (KOOS) subscale of sport/recreation (Sport/Rec), KOOS subscale of quality of life (QoL), Lysholm knee score (LKS), Tegner activity scale (TAS), recurrent ACL ruptures, or need for further surgery in either knee. Analysis of variance was used to compare PROs; the Wilcoxon test was used for the TAS; and the chi-square test was used for recurrence of ACL ruptures, meniscal injuries, and contralateral ACL ruptures ( P < .05).
RESULTS
A total of 55 patients were randomized: 27 to group A (female:male ratio = 15:12; mean age, 22.3 ± 3.7 years) and 28 to group B (female:male ratio = 17:11; mean age, 21.8 ± 4.1 years). At 2-year follow-up, group A had a similar IKDC score (90.9 ± 10.7 vs 94.2 ± 11.2; respectively; P = .21), lower KOOS Sport/Rec score (91.5 ± 6.4 vs 95.3 ± 4.4, respectively; P = .02), similar KOOS QoL score (92.0 ± 4.8 vs 95.1 ± 4.3, respectively; P = .14), lower LKS score (92.5 ± 4.8 vs 96.8 ± 8.0, respectively; P = .004), lower TAS score (median, 7 [range, 7-9] vs 8 [range, 8-10], respectively; P = .03), higher rate of recurrence (14.8% vs 0.0%, respectively; P < .001), similar rate of meniscal tears (14.8% vs 3.6%, respectively; P = .14), and similar rate of contralateral ACL ruptures (3.7% vs 3.6%, respectively; P = .99) relative to group B.
CONCLUSION
The augmentation of ACL reconstruction with MITBT reduced the risk of recurrent ACL ruptures in knees with a residual pivot shift after ACL reconstruction and improved KOOS Sport/Rec, LKS, and TAS scores.
REGISTRATION
ACTRN12618001043224 (Australian New Zealand Clinical Trials Registry).",2020,"The augmentation of ACL reconstruction with MITBT reduced the risk of recurrent ACL ruptures in knees with a residual pivot shift after ACL reconstruction and improved KOOS Sport/Rec, LKS, and TAS scores.
","['55 patients were randomized: 27 to group A (female:male ratio = 15:12; mean age, 22.3 ± 3.7 years) and 28 to group B (female:male ratio = 17:11; mean age, 21.8 ± 4.1 years', 'Patients with a primary ACL rupture satisfying the following inclusion criteria were enrolled: first ACL rupture, involved in pivoting sports, skeletally mature, no meniscal repair performed, and residual pivot shift relative to the contralateral uninjured knee immediately after ACL reconstruction', 'patients with a residual pivot shift']","['modified iliotibial band tenodesis (MITBT', 'anterolateral soft tissue augmentation to anterior cruciate ligament (ACL) reconstruction', 'Anterior Cruciate Ligament Reconstruction Using an Autologous Hamstring Tendon Graft']","['similar KOOS QoL score', 'rate of contralateral ACL ruptures', 'recurrence of ACL ruptures, meniscal injuries, and contralateral ACL ruptures', 'lower LKS score', 'KOOS Sport/Rec, LKS, and TAS scores', 'lower KOOS Sport/Rec score', 'lower TAS score', 'rate of recurrence', 'International Knee Documentation Committee (IKDC) score, Knee injury and Osteoarthritis Outcome Score (KOOS) subscale of sport/recreation (Sport/Rec), KOOS subscale of quality of life (QoL), Lysholm knee score (LKS), Tegner activity scale (TAS), recurrent ACL ruptures, or need for further surgery in either knee', 'similar IKDC score', 'rate of meniscal tears']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517696', 'cui_str': '3.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0407887', 'cui_str': 'Repair of meniscus (procedure)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C1260974', 'cui_str': 'Tenodesis'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1279739', 'cui_str': 'Tendon transplantation (procedure)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0034380'}, {'cui': 'C2200320', 'cui_str': 'Lysholm Knee Scale'}, {'cui': 'C3850078', 'cui_str': 'Tegner Activity Scale'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0039409', 'cui_str': 'Tears'}]",55.0,0.105053,"The augmentation of ACL reconstruction with MITBT reduced the risk of recurrent ACL ruptures in knees with a residual pivot shift after ACL reconstruction and improved KOOS Sport/Rec, LKS, and TAS scores.
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Porter', 'Affiliation': 'Canberra Orthopaedics and Sports Medicine, Bruce, Australian Capital Territory, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Shadbolt', 'Affiliation': 'Canberra Hospital, Garran, Australian Capital Territory, Australia.'}]",The American journal of sports medicine,['10.1177/0363546520910148']
353,32193200,"Effects of the low carbohydrate, high fat diet on glycemic control and body weight in patients with type 2 diabetes: experience from a community-based cohort.","OBJECTIVE
The optimal diet to improve glycemia in patients with type 2 diabetes remains unclear. Low carbohydrate, high fat (LCHF) diets can improve glycemic control, but have not been investigated in real-world settings.
RESEARCH DESIGN AND METHODS
We investigated effects of the LCHF diet compared with usual care in a community-based cohort of patients with type 2 diabetes by performing a retrospective study of 49 patients who followed the LCHF diet for ≥3 months, and compared glycemic outcomes with age-matched and body mass index (BMI)-matched controls who received usual care (n=75). The primary outcome was change in A1C from baseline to the end of follow-up.
RESULTS
Compared with the usual care group, the LCHF group showed a significantly greater reduction in A1C (-1.29% (95% CI -1.75 to -0.82; p<0.001)) and body weight (-12.8 kg (95% CI -14.7 to -10.8; p<0.001) at the end of follow-up after adjusting for age, sex, baseline A1C, BMI, baseline insulin dose. Of the patients initially taking insulin therapy in the LCHF group, 100% discontinued it or had a reduction in dose, compared with 23.1% in the usual care group (p<0.001). The LCHF group also had significantly greater reduction in fasting plasma glucose (-43.5 vs -8.5 mg/mL; p=0.03) compared with usual care.
CONCLUSIONS
In a community-based cohort of type 2 diabetes, the LCHF diet was associated with superior A1C reduction, greater weight loss and significantly more patients discontinuing or reducing antihyperglycemic therapies suggesting that the LCHF diet may be a metabolically favorable option in the dietary management of type 2 diabetes.",2020,"Compared with the usual care group, the LCHF group showed a significantly greater reduction in A1C (-1.29% (95% CI -1.75 to -0.82; p<0.001)) and body weight (-12.8 kg (95% CI -14.7 to -10.8; p<0.001) at the end of follow-up after adjusting for age, sex, baseline A1C, BMI, baseline insulin dose.","['patients with type', 'in a community-based cohort of patients with type 2 diabetes by performing a retrospective study of 49 patients who followed the LCHF diet for ≥3 months, and compared glycemic outcomes with age-matched and body mass index (BMI)-matched controls who received usual care (n=75', 'patients with type 2 diabetes']","['low carbohydrate, high fat diet', 'usual care', 'LCHF', 'LCHF diet', 'Low carbohydrate, high fat (LCHF) diets']","['A1C', 'body weight', 'weight loss', 'glycemic control and body weight', 'change in A1C', 'fasting plasma glucose']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Studies'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0521974', 'cui_str': 'Diet, High-Fat'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",49.0,0.0297063,"Compared with the usual care group, the LCHF group showed a significantly greater reduction in A1C (-1.29% (95% CI -1.75 to -0.82; p<0.001)) and body weight (-12.8 kg (95% CI -14.7 to -10.8; p<0.001) at the end of follow-up after adjusting for age, sex, baseline A1C, BMI, baseline insulin dose.","[{'ForeName': 'Shabina Roohi', 'Initials': 'SR', 'LastName': 'Ahmed', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Diabetes and Metabolism, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA Shabina.r.ahmed@gmail.com.'}, {'ForeName': 'Sridevi', 'Initials': 'S', 'LastName': 'Bellamkonda', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Mihail', 'Initials': 'M', 'LastName': 'Zilbermint', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Diabetes and Metabolism, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Jiangxia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Biostatistics Consulting Center, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Rita Rastogi', 'Initials': 'RR', 'LastName': 'Kalyani', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Diabetes and Metabolism, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000980']
354,32236822,Induction Versus Escalation in Multiple Sclerosis: A 10-Year Real World Study.,"In this independent, multicenter, post-marketing study, we directly compare induction immunosuppression versus escalation strategies on the risk of reaching the disability milestone of Expanded Disability Status Scale (EDSS) ≥ 6.0 over 10 years in previously untreated patients with relapsing-remitting multiple sclerosis. We collected data of patients who started interferon beta (escalation) versus mitoxantrone or cyclophosphamide (induction) as initial treatment. Main eligibility criteria included an EDSS score ≤ 4.0 at treatment start and either ≥ 2 relapses or 1 disabling relapse with evidence of ≥ 1 gadolinium-enhancing lesion at magnetic resonance imaging scan in the pre-treatment year. Since patients were not randomized to treatment group, we performed a propensity score (PS)-based matching procedure to select individuals with homogeneous baseline characteristics. Comparisons were then conducted using Cox models stratified by matched pairs. Overall, 75 and 738 patients started with induction and escalation, respectively. Patients in the induction group were older and more disabled than those in the escalation group (p < 0.05). The PS-matching procedure retained 75 patients per group. In the re-sampled population, a lower proportion of patients reached the outcome after induction (21/75, 28.0%) than escalation (29/75, 38.7%) (hazard ratio = 0.48; p = 0.024). Considering the whole sample, serious adverse events occurred more frequently after induction (8/75, 10.7%) than escalation (18/738, 2.4%) (odds ratio = 3.36, p = 0.015). These findings suggest that, in patients with poor prognostic factors, induction was more effective than escalation in reducing the risk of reaching the disability milestone, albeit with a worse safety profile. Future studies are warranted to explore if newer induction agents may provide a more advantageous long-lasting risk:benefit profile.",2020,Patients in the induction group were older and more disabled than those in the escalation group (p < 0.05).,"['Multiple Sclerosis', 'patients who started interferon beta (escalation) versus', 'Main eligibility criteria included an EDSS score\u2009≤\u20094.0 at treatment start and either ≥\u20092 relapses or 1 disabling relapse with evidence of ≥\u20091 gadolinium-enhancing lesion at magnetic resonance imaging scan in the pre-treatment year']",['mitoxantrone or cyclophosphamide (induction'],"['serious adverse events', 'disability milestone of Expanded Disability Status Scale (EDSS)\u2009≥']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0015980', 'cui_str': 'Interferon-beta'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}]",,0.0266652,Patients in the induction group were older and more disabled than those in the escalation group (p < 0.05).,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Prosperini', 'Affiliation': 'Department of Neurosciences, S. Camillo-Forlanini Hospital, C.ne Gianicolense 87, 00152, Rome, Italy. luca.prosperini@gmail.com.'}, {'ForeName': 'Chiara Rosa', 'Initials': 'CR', 'LastName': 'Mancinelli', 'Affiliation': 'Multiple Sclerosis Centre, ASST Spedali Civili di Brescia, P.O. Montichiari, Via Ciotti 154, 25018, Montichiari, BS, Italy.'}, {'ForeName': 'Claudio Marcello', 'Initials': 'CM', 'LastName': 'Solaro', 'Affiliation': ""Rehabilitation Unit 'Mons. L. Novarese' Hospital, Loc. Trompone, 13040, Moncrivello, VC, Italy.""}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Nociti', 'Affiliation': ""Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, L.go A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Shalom', 'Initials': 'S', 'LastName': 'Haggiag', 'Affiliation': 'Department of Neurosciences, S. Camillo-Forlanini Hospital, C.ne Gianicolense 87, 00152, Rome, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Cordioli', 'Affiliation': 'Multiple Sclerosis Centre, ASST Spedali Civili di Brescia, P.O. Montichiari, Via Ciotti 154, 25018, Montichiari, BS, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'De Giglio', 'Affiliation': 'Neurology Unit, S. Filippo Neri Hospital, Via G. Martinotti 20, 00135, Rome, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'De Rossi', 'Affiliation': 'Multiple Sclerosis Centre, ASST Spedali Civili di Brescia, P.O. Montichiari, Via Ciotti 154, 25018, Montichiari, BS, Italy.'}, {'ForeName': 'Simonetta', 'Initials': 'S', 'LastName': 'Galgani', 'Affiliation': 'Department of Neurosciences, S. Camillo-Forlanini Hospital, C.ne Gianicolense 87, 00152, Rome, Italy.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rasia', 'Affiliation': 'Multiple Sclerosis Centre, ASST Spedali Civili di Brescia, P.O. Montichiari, Via Ciotti 154, 25018, Montichiari, BS, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Ruggieri', 'Affiliation': 'Department of Neurosciences, S. Camillo-Forlanini Hospital, C.ne Gianicolense 87, 00152, Rome, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Tortorella', 'Affiliation': 'Department of Neurosciences, S. Camillo-Forlanini Hospital, C.ne Gianicolense 87, 00152, Rome, Italy.'}, {'ForeName': 'Ruggero', 'Initials': 'R', 'LastName': 'Capra', 'Affiliation': 'Multiple Sclerosis Centre, ASST Spedali Civili di Brescia, P.O. Montichiari, Via Ciotti 154, 25018, Montichiari, BS, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Mirabella', 'Affiliation': ""Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, L.go A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gasperini', 'Affiliation': 'Department of Neurosciences, S. Camillo-Forlanini Hospital, C.ne Gianicolense 87, 00152, Rome, Italy.'}]",Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics,['10.1007/s13311-020-00847-0']
355,32237922,Combined cranberry supplementation and weight loss diet in non-alcoholic fatty liver disease: a double-blind placebo-controlled randomized clinical trial.,"A double-blind placebo-controlled randomised clinical trial was conducted on 41 patients with non-alcoholic fatty liver disease (NAFLD). Participants were randomly allocated to receive either a cranberry supplement or a placebo for 12 weeks. Both groups were assigned to follow a weight loss diet. At the end of the study, alanine aminotransferase and insulin decreased significantly in both groups ( p < .05); however, this reduction was significantly greater in the cranberry group than in the placebo group ( p < .05). Significant improvements in insulin resistance were observed in the cranberry group and between the two groups ( p < .001 and p = .020, respectively). Also, there was an improvement in steatosis grade and anthropometric measurements in both groups ( p < .05), and there was no significant difference between the two groups in regard to these factors ( p > .05). It seems that 288 mg of cranberry extract might improve managing NAFLD, which is equivalent to 26 g of dried cranberry.",2020,"At the end of the study, alanine aminotransferase and insulin decreased significantly in both groups ( p < .05); however, this reduction was significantly greater in the cranberry group than in the placebo group ( p < .05).","['non-alcoholic fatty liver disease', '41 patients with non-alcoholic fatty liver disease (NAFLD']","['cranberry supplement or a placebo', 'Combined cranberry supplementation and weight loss diet', 'placebo', 'cranberry extract']","['insulin resistance', 'steatosis grade and anthropometric measurements', 'alanine aminotransferase and insulin']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",41.0,0.457545,"At the end of the study, alanine aminotransferase and insulin decreased significantly in both groups ( p < .05); however, this reduction was significantly greater in the cranberry group than in the placebo group ( p < .05).","[{'ForeName': 'Razie', 'Initials': 'R', 'LastName': 'Hormoznejad', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mohammad Shahi', 'Affiliation': 'Hyperlipidemia Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Fakher', 'Initials': 'F', 'LastName': 'Rahim', 'Affiliation': 'Clinical Research Development Unit, Golestan Hospital, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Helli', 'Affiliation': 'Hyperlipidemia Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Pezhman', 'Initials': 'P', 'LastName': 'Alavinejad', 'Affiliation': 'Alimentary Tract Research Center, Ahvaz Imam Hospital, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Asaad', 'Initials': 'A', 'LastName': 'Sharhani', 'Affiliation': 'Department of Epidemiology, and Biostatistics, School of public health, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}]",International journal of food sciences and nutrition,['10.1080/09637486.2020.1746957']
356,32237056,Effects of postoperative active warming and early exercise on postoperative body temperature distribution: Non-blinded and randomized controlled trial.,"AIM
We tested a hypothesis that postoperative active warming and/or arm leg stretches reduce the difference between core and skin temperatures (primary variable) improving the peripheral circulation immediately after major abdominal surgery.
METHODS
Fifty-one patients undergoing major abdominal surgeries were randomly assigned to receive one of three interventions immediately after surgery; routine care (control group), mild intermittent exercise on the bed (exercise group), and forced-air warming (warming group). Core and skin temperatures and perfusion index were continuously measured from anesthesia induction to 12 h after arrival at the ward.
RESULTS
Core body temperature was maintained over 37°C with a relatively greater gap between core and skin temperatures over 1°C and reduced perfusion index in the early postoperative period in the control group. In the warming group, the reduced skin temperature at arrival at the ward approximated to the core temperature leading to significant reduction of the temperature gap and increasing the perfusion index to the preoperative level. Although less evident, both the temperature gap and peripheral perfusion significantly improved in the exercise group after 6 and 8 h after arrival at the ward, respectively.
CONCLUSIONS
Vasoconstriction in response to cessation after anesthesia and surgery serves to maintain core temperature, but impairs peripheral circulation. Active warming and intermittent mild exercise immediately after arrival at the ward reduces the temperature gap and improves peripheral circulation during the early postoperative period. While cost-effectiveness needs to be considered before clinical application of the intervention, the cost-free mild exercise may be a feasible option for improving postoperative patient care.",2020,"Although less evident, both the temperature gap and peripheral perfusion significantly improved in the exercise group after 6 and 8 h after arrival at the ward, respectively.
",['Fifty-one patients undergoing major abdominal surgeries'],"['postoperative active warming and early exercise', 'three interventions immediately after surgery; routine care (control group), mild intermittent exercise on the bed (exercise group), and forced-air warming (warming group']","['temperature gap and peripheral perfusion', 'postoperative body temperature distribution', 'perfusion index', 'peripheral circulation', 'Core and skin temperatures and perfusion index', 'reduced skin temperature']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0425710', 'cui_str': 'Peripheral blood flow'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C2964282', 'cui_str': 'Perfusion Index'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",51.0,0.0387257,"Although less evident, both the temperature gap and peripheral perfusion significantly improved in the exercise group after 6 and 8 h after arrival at the ward, respectively.
","[{'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kameda', 'Affiliation': 'Frontier Practice Nursing, Graduate School of Nursing, Chiba University, Chiba, Japan.'}, {'ForeName': 'Shiroh', 'Initials': 'S', 'LastName': 'Isono', 'Affiliation': 'Department of Anesthesiology, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Shinobu', 'Initials': 'S', 'LastName': 'Okada', 'Affiliation': 'Frontier Practice Nursing, Graduate School of Nursing, Chiba University, Chiba, Japan.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12335']
357,32237060,Three contemporary thin-strut drug-eluting stents implanted in severely calcified coronary lesions of participants in a randomized all-comers trial.,"OBJECTIVE
The objective was to assess the 2-year clinical performance of three drug-eluting stents in all-comer patients with severely calcified coronary lesions.
BACKGROUND
Severe lesion calcification increases cardiovascular event risk after coronary stenting, but there is a lack of data on the clinical outcome of all-comers with severely calcified lesions who were treated with more recently introduced drug-eluting stents.
METHODS
The BIO-RESORT trial (clinicaltrials.gov: NCT01674803) randomly assigned 3,514 all-comer patients to biodegradable polymer Synergy everolimus-eluting stents (EES) or Orsiro sirolimus-eluting stents (SES), versus durable polymer Resolute Integrity zotarolimus-eluting stents (ZES). In a post hoc analysis, we assessed 783 patients (22.3%) with at least one severely calcified target lesion.
RESULTS
At 2-year follow-up (available in 99% of patients), the main composite endpoint target vessel failure occurred in 19/252 (7.6%) of the EES and in 33/265 (12.6%) of the ZES-treated patients (p = .07). Target vessel failure occurred in 24/266 (9.1%) of the SES-treated patients (vs. ZES: p = .21). There was a difference in target vessel revascularization, which was required in EES in 6/252 (2.4%) patients and in ZES in 20/265 (7.7%) patients (p = .01); the target vessel revascularization rate in SES was 9/266 (3.4%, vs. ZES: p = .04). Multivariate analysis showed that implantation of EES, but not SES, was independently associated with lower target vessel revascularization rates than in ZES.
CONCLUSIONS
In BIO-RESORT participants with severely calcified target lesions, treatment with EES was associated with a lower 2-year target vessel revascularization rate than treatment with ZES.",2020,"Multivariate analysis showed that implantation of EES, but not SES, was independently associated with lower target vessel revascularization rates than in ZES.
","['783 patients (22.3%) with at least one severely calcified target lesion', 'all-comer patients with severely calcified coronary lesions']","['drug-eluting stents', 'ZES', 'biodegradable polymer Synergy everolimus-eluting stents (EES) or Orsiro sirolimus-eluting stents (SES), versus durable polymer Resolute Integrity zotarolimus-eluting stents (ZES']","['2-year clinical performance', 'target vessel revascularization', 'target vessel revascularization rate in SES', 'target vessel revascularization rates', 'vessel failure', '2-year target vessel revascularization rate', 'Target vessel failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1700035', 'cui_str': 'Zotarolimus'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",783.0,0.148747,"Multivariate analysis showed that implantation of EES, but not SES, was independently associated with lower target vessel revascularization rates than in ZES.
","[{'ForeName': 'Rosaly A', 'Initials': 'RA', 'LastName': 'Buiten', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Eline H', 'Initials': 'EH', 'LastName': 'Ploumen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zocca', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Carine J M', 'Initials': 'CJM', 'LastName': 'Doggen', 'Affiliation': 'Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'K Gert', 'Initials': 'KG', 'LastName': 'van Houwelingen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Danse', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': 'Department of Cardiology, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Stoel', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Scholte', 'Affiliation': 'Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Gerard C M', 'Initials': 'GCM', 'LastName': 'Linssen', 'Affiliation': 'Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, The Netherlands.'}, {'ForeName': 'Frits H A F', 'Initials': 'FHAF', 'LastName': 'de Man', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28886']
358,32237115,"The Effect of CYP3A Induction and Inhibition on the Pharmacokinetics of Laquinimod, a Novel Neuroimmunomodulator.","Laquinimod, a neuroimmunomodulator, is extensively metabolized by cytochrome P450 (CYP) 3A4, and modulations of CYP3A4 activity may lead to alterations in the pharmacokinetics and/or clinical effects of laquinimod. To determine the drug-drug interaction potential of laquinimod with CYP3A inhibitors and inducers, interaction assessments were conducted in healthy volunteers using single-dose administration of laquinimod before and after multiple dosing of CYP3A inhibitors (ketoconazole, fluconazole, and cimetidine) or a CYP3A4 inducer (rifampin). For ketoconazole, subjects (n = 14) received laquinimod 0.6 mg following 1 day of ketoconazole (400 mg daily) pretreatment, a single concomitant dose, and 28 additional days. For fluconazole, subjects (n = 14) received laquinimod 0.6 mg after a single fluconazole dose of 400 mg followed by 200-mg daily fluconazole administration for 20 additional days. For cimetidine, subjects (n = 14) received laquinimod 0.6 mg following 1 day of cimetidine (800 mg twice daily) pretreatment, a single concomitant dose, and 21 additional days. For rifampin, subjects (n = 14) received laquinimod 0.6 mg following 9 days of rifampin (600 mg daily) pretreatment, a single concomitant dose, and 12 additional days. Coadministration of laquinimod with CYP3A inhibitors, ketoconazole, fluconazole, and cimetidine increased laquinimod area under the plasma concentration-time curve from time zero to infinity by approximately 3.1-, 2.5-, and 1.1-fold, respectively. Coadministration of laquinimod with rifampin decreased laquinimod area under the plasma concentration-time curve from time zero to infinity by 5-fold. These results indicate that coadministration of laquinimod with moderate to strong inhibitors of CYP3A or strong inducers of CYP3A may give rise to significant pharmacokinetic drug interactions.",2020,Coadministration of laquinimod with rifampin decreased laquinimod area under the plasma concentration-time curve from time zero to infinity by 5-fold.,['healthy volunteers'],"['laquinimod with CYP3A inhibitors', 'Laquinimod', 'laquinimod 0.6 mg following 1 day of cimetidine', 'ketoconazole', 'laquinimod 0.6 mg following 1 day of ketoconazole', 'CYP3A inhibitors (ketoconazole, fluconazole, and cimetidine) or a CYP3A4 inducer (rifampin', 'cimetidine', 'laquinimod 0.6 mg following 9 days of rifampin', 'laquinimod with CYP3A inhibitors, ketoconazole, fluconazole, and cimetidine', 'laquinimod with rifampin', 'fluconazole', 'laquinimod 0.6 mg after a single fluconazole dose of 400 mg followed by 200-mg daily fluconazole']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1260208', 'cui_str': 'laquinimod'}, {'cui': 'C3850056', 'cui_str': 'P450 CYP3A Inhibitors'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008783', 'cui_str': 'Cimetidine'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C3850041', 'cui_str': 'CYP3A4 Inducers'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4319558', 'cui_str': '200'}]",[],,0.0525811,Coadministration of laquinimod with rifampin decreased laquinimod area under the plasma concentration-time curve from time zero to infinity by 5-fold.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Elgart', 'Affiliation': 'Teva Pharmaceutical Industries Ltd, Netanya, Israel.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Greenblatt', 'Affiliation': 'Tufts University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Pippa S', 'Initials': 'PS', 'LastName': 'Loupe', 'Affiliation': 'Teva Pharmaceutical Industries Ltd, Netanya, Israel.'}, {'ForeName': 'Arik A', 'Initials': 'AA', 'LastName': 'Zur', 'Affiliation': 'Teva Pharmaceutical Industries Ltd, Netanya, Israel.'}, {'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Weiss', 'Affiliation': 'Teva Pharmaceutical Industries Ltd, Netanya, Israel.'}, {'ForeName': 'Dorit', 'Initials': 'D', 'LastName': 'Mimrod', 'Affiliation': 'Teva Pharmaceutical Industries Ltd, Netanya, Israel.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Spiegelstein', 'Affiliation': 'Teva Pharmaceutical Industries Ltd, Netanya, Israel.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.785']
359,32125875,Repair With Dynamic Intraligamentary Stabilization Versus Primary Reconstruction of Acute Anterior Cruciate Ligament Tears: 2-Year Results From a Prospective Randomized Study.,"BACKGROUND
Anterior cruciate ligament (ACL) repair has once again become a focus of research because of the development of new techniques.
PURPOSE/HYPOTHESIS
The purpose was to compare the functional results and recurrent instability rates in patients undergoing ACL repair with dynamic intraligamentary stabilization (DIS) versus primary ACL reconstruction (ACLR) for acute isolated ACL tears. The hypothesis was that functional results and knee joint stability after ACL repair with DIS would be comparable with that after ACLR.
STUDY DESIGN
Randomized clinical trial; Level of evidence, 1.
METHODS
A total of 85 patients with acute ACL tears were randomized to undergo either ACL repair with DIS or primary ACLR. The preinjury activity level and function were recorded. Follow-up examinations were performed at 6 weeks and 6, 12, and 24 months postoperatively. Anterior tibial translation (ATT) was evaluated using Rolimeter testing. The Tegner activity scale, International Knee Documentation Committee (IKDC) subjective form, and Lysholm knee scoring scale scores were obtained. Clinical failure was defined as ΔATT >3 mm in combination with subjective instability. Recurrent instability and other complications were recorded.
RESULTS
There were 83 patients (97.6%) who were successfully followed until 2 years. ATT was significantly increased in the DIS group compared with the ACLR group (ΔATT, 1.9 vs 0.9 mm, respectively; P = .0086). A total of 7 patients (16.3%) in the DIS group had clinical failure and underwent single-stage revision. In the ACLR group, 5 patients (12.5%) had failure of the reconstruction procedure; 4 of these patients required 2-stage revision. The difference in the failure rate was not significant ( P = .432). There were 4 patients (3 in the DIS group and 1 in the ACLR group) who showed increased laxity (ΔATT >3 mm) without subjective instability and did not require revision. Recurrent instability was associated with young age (<25 years) and high Tegner scores (>6) in both groups. No significant differences between ACL repair with DIS and ACLR were found for the Tegner, IKDC, and Lysholm scores at any time.
CONCLUSION
Whereas ATT measured by Rolimeter testing was significantly increased after ACL repair with DIS, clinical failure was similar to that after ACLR. In addition, functional results after ACL repair with DIS for acute tears were comparable with those after ACLR. The current study supports the use of ACL repair with DIS as an option to treat acute ACL tears.
REGISTRATION
DRKS00015466 (German Clinical Trials Register).",2020,"No significant differences between ACL repair with DIS and ACLR were found for the Tegner, IKDC, and Lysholm scores at any time.
","['83 patients (97.6%) who were successfully followed until 2 years', '85 patients with acute ACL tears', 'patients undergoing', 'Acute Anterior Cruciate Ligament Tears']","['ACL repair with dynamic intraligamentary stabilization (DIS) versus primary ACL reconstruction (ACLR', 'Repair With Dynamic Intraligamentary Stabilization Versus Primary Reconstruction', 'Anterior cruciate ligament (ACL) repair', 'ACLR', 'ACL repair with DIS or primary ACLR', 'ACL repair with DIS']","['ACL repair with DIS and ACLR', 'Tegner activity scale, International Knee Documentation Committee (IKDC) subjective form, and Lysholm knee scoring scale scores', 'Recurrent instability and other complications', 'Recurrent instability', 'preinjury activity level and function', 'Anterior tibial translation (ATT', 'failure rate', 'clinical failure', 'Tegner, IKDC, and Lysholm scores', 'knee joint stability', 'Clinical failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0409312', 'cui_str': 'Anterior Cruciate Ligament Tear'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0078960', 'cui_str': 'Anterior Cranial Cruciate Ligament'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C3850078', 'cui_str': 'Tegner Activity Scale'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C4305267', 'cui_str': 'Lysholm Knee Scoring Scale score'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0427261', 'cui_str': 'Knee joint stability (observable entity)'}]",85.0,0.0577479,"No significant differences between ACL repair with DIS and ACLR were found for the Tegner, IKDC, and Lysholm scores at any time.
","[{'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Kösters', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Glasbrenner', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Spickermann', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kittl', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Domnick', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Mirco', 'Initials': 'M', 'LastName': 'Herbort', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Raschke', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Schliemann', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}]",The American journal of sports medicine,['10.1177/0363546520905863']
360,31711229,Kinetics and Interrelations of the Renin Aldosterone Response to Acute Psychosocial Stress: A Neglected Stress System.,"CONTEXT
The renin-angiotensin-aldosterone system (RAAS) plays an important role in cardiovascular homeostasis and its dysfunction relates to negative health consequences. Acute psychosocial stress seems to activate the RAAS in humans, but stress kinetics and interrelations of RAAS parameters compared with a nonstress control group remain inconclusive.
OBJECTIVE
We systematically investigated in a randomized placebo-controlled design stress kinetics and interrelations of the reactivity of RAAS parameters measured in plasma and saliva to standardized acute psychosocial stress induction.
METHODS
58 healthy young men were assigned to either a stress or a placebo control group. The stress group underwent the Trier Social Stress Test (TSST), while the control group underwent the placebo TSST. We repeatedly assessed plasma renin, and plasma and salivary aldosterone before and up to 3 hours after stress/placebo. We simultaneously assessed salivary cortisol to validate successful stress induction and to test for interrelations.
RESULTS
Acute psychosocial stress induced significant increases in all endocrine measures compared with placebo-stress (all P ≤ .041). Highest renin levels were observed 1 minute after stress, and highest aldosterone and cortisol levels 10 and 20 minutes after stress, with salivary aldosterone starting earlier at 1 minute after stress. Renin completed recovery at 10 minutes, cortisol at 60 minutes, salivary aldosterone at 90 minutes, and plasma aldosterone at 180 minutes after stress. Stress increase scores of all endocrine measures related to each other, as did renin and cortisol areas under the curve with respect to increase (AUCi) and salivary and plasma aldosterone AUCi (all P ≤ .047).
CONCLUSIONS
Our findings suggest that in humans acute psychosocial stress induces a differential and interrelated RAAS parameter activation pattern. Potential implications for stress-related cardiovascular risk remain to be elucidated.",2020,"RESULTS
Acute psychosocial stress induced significant increases in all endocrine measures as compared to placebo-stress (p´s≤.041).","['acute psychosocial stress', '58 healthy young men']","['Trier-Social-Stress-Test (TSST', 'Renin-Angiotensin-Aldosterone-System (RAAS', 'renin aldosterone response', 'placebo-control group', 'placebo-TSST', 'placebo']","['endocrine measures', 'Renin completed recovery at 10min, cortisol at 60min, salivary aldosterone at 90min, and plasma aldosterone', 'plasma renin, plasma and salivary aldosterone', 'Highest renin levels', 'did renin and cortisol AUCi´s and salivary and plasma aldosterone AUCi´s']","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",58.0,0.0225281,"RESULTS
Acute psychosocial stress induced significant increases in all endocrine measures as compared to placebo-stress (p´s≤.041).","[{'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Gideon', 'Affiliation': 'Biological Work and Health Psychology, University of Konstanz, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Sauter', 'Affiliation': 'Biological Work and Health Psychology, University of Konstanz, Germany.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Fieres', 'Affiliation': 'Biological Work and Health Psychology, University of Konstanz, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Biological Work and Health Psychology, University of Konstanz, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Renner', 'Affiliation': 'Health Psychology, University of Konstanz, Germany.'}, {'ForeName': 'Petra H', 'Initials': 'PH', 'LastName': 'Wirtz', 'Affiliation': 'Biological Work and Health Psychology, University of Konstanz, Germany.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz190']
361,32234247,Does 20-min rounding reduce falls in an aged-care setting? A pilot intervention study.,"BACKGROUND
This study investigated if implementation of a 20-min rounding intervention can reduce falls in aged care settings.
METHODS
Participants (aged 66-99 years) from five aged care facilities were randomly allocated to intervention (n = 20) or control groups (n = 21). The intervention consisted of 20-min rounding observations over a six month period. The number of falls for all residents of each aged care facility was also collected.
RESULTS
For participants of the intervention study, there were no differences for number of falls in the intervention compared to the control group (mean(95%CI) control:2.3(0.8-3.7), intervention:4.0(2.5-5.5), p = 0.108). There was a trend for a decreased average number of falls across all aged care sites (mean±SD, 60.4 ± 35.7 falls occurred prior vs. 53.4 ± 37.4 during the intervention, p = 0.056). There were no fall related fractures in the intervention group during the study.
CONCLUSIONS
This study suggests that 20-min rounding may decrease falls for all residents of aged care sites.",2020,"For participants of the intervention study, there were no differences for number of falls in the intervention compared to the control group (mean(95%CI) control:2.3(0.8-3.7), intervention:4.0(2.5-5.5), p = 0.108).",['Participants (aged 66-99\xa0years) from five aged care facilities'],['20-min rounding intervention'],"['number of falls', 'average number of falls']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0575126', 'cui_str': 'Number of falls'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.0367425,"For participants of the intervention study, there were no differences for number of falls in the intervention compared to the control group (mean(95%CI) control:2.3(0.8-3.7), intervention:4.0(2.5-5.5), p = 0.108).","[{'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Roberts', 'Affiliation': 'Western District Health Service, 20 Foster St, Hamilton, VIC 3300, Australia. Electronic address: Bronwyn.Roberts@wdhs.net.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Holloway-Kew', 'Affiliation': 'Deakin University, Victoria, Australia.'}, {'ForeName': 'Tatum', 'Initials': 'T', 'LastName': 'Pretorius', 'Affiliation': 'Western District Health Service, 20 Foster St, Hamilton, VIC 3300, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hosking', 'Affiliation': 'Deakin University, Victoria, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Kennedy', 'Affiliation': 'Deakin University, Victoria, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Armstrong', 'Affiliation': 'Western District Health Service, 20 Foster St, Hamilton, VIC 3300, Australia.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.03.003']
362,32041720,Prospective exploratory study to assess the safety and efficacy of aflibercept in cystoid macular oedema associated with retinitis pigmentosa.,"AIMS
To report the safety and efficacy of intravitreal aflibercept (Eylea) (ivA) for retinitis pigmentosa-associated cystoid macular oedema (RP-CMO) at 12 months via mean central macular thickness (CMT) and reported adverse events.
METHODS
A prospective, exploratory, phase II, non-randomised, single-centre, open-label, 1-arm clinical trial involving 30 eyes of 30 patients. Serial ivA was given via loading dose (three injections) followed by treat and extend protocol over 12 months.
RESULTS
Twenty-nine out of 30 (96.7%) patients completed 12 months of follow-up. A total of four to 11 injections per patient were given over the 12 month study. No statistically significant reduction of CMT or visual acuity (VA) improvement was demonstrated in the group overall. Eleven out of 29 (37.9%) participants were considered as 'responders', demonstrating at least an 11% reduction of CMT at 12 months on spectral domain optical coherence tomography compared with baseline. A reduction of CMT by mean (SD) 28.1% (12.9 %) was observed in responders at 12 months, however, no statistically significant corresponding improvement in best corrected VA was seen. Baseline characteristics were similar between responder and non-responder groups. No clinically significant adverse events were deemed secondary to ivA.
CONCLUSION
This first prospective exploratory study demonstrates both the safety and acceptability of serial ivA in patients with RP-CMO, effective at reducing CMT in 37.9% of patients. All patients demonstrating anatomical response did so after their first injection. Longer duration of CMO did not negatively affect response to anti-VEGF. Further study in a larger cohort of patients with shorter CMO duration would be valuable to better establish the utility of VEGF blockade in RP-CMO.
TRIAL REGISTRATION NUMBERS
EudraCT (2015-003723-65); ClinicalTrials.gov (NCT02661711).",2020,No statistically significant reduction of CMT or visual acuity (VA) improvement was demonstrated in the group overall.,"['cystoid macular oedema associated with retinitis pigmentosa', '30 eyes of 30 patients', 'patients with RP-CMO, effective at reducing CMT in 37.9% of patients', 'retinitis pigmentosa-associated cystoid macular oedema (RP-CMO']","['aflibercept', 'intravitreal aflibercept (Eylea) (ivA']","['safety and efficacy', 'Longer duration of CMO', 'CMT or visual acuity (VA) improvement']","[{'cui': 'C0024440', 'cui_str': 'Macular Dystrophy, Dominant Cystoid'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0035334', 'cui_str': 'Pigmentary Retinopathy'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",30.0,0.0970614,No statistically significant reduction of CMT or visual acuity (VA) improvement was demonstrated in the group overall.,"[{'ForeName': 'Stacey A', 'Initials': 'SA', 'LastName': 'Strong', 'Affiliation': 'UCL Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'Moorfields Eye Hospital, London, UK.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': 'Primary Care and Public Health Sciences, Kings College London, London, UK.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xing', 'Affiliation': 'Moorfields Eye Hospital, London, UK.'}, {'ForeName': 'Michalis', 'Initials': 'M', 'LastName': 'Georgiou', 'Affiliation': 'UCL Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Simona Degli', 'Initials': 'SD', 'LastName': 'Esposti', 'Affiliation': 'Moorfields Eye Hospital, London, UK.'}, {'ForeName': 'Angelos', 'Initials': 'A', 'LastName': 'Kalitzeos', 'Affiliation': 'UCL Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Webster', 'Affiliation': 'UCL Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Michaelides', 'Affiliation': 'UCL Institute of Ophthalmology, University College London, London, UK michel.michaelides@ucl.ac.uk.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-315152']
363,32222767,Effectiveness of Mindfulness-Based Relapse Prevention Program as an Adjunct to the Standard Treatment for Smoking: A Pragmatic Design Pilot Study.,"INTRODUCTION
Posttreatment relapse is a major roadblock to stemming the global epidemic of tobacco-related illness. This article presents results from a pilot trial evaluating the feasibility and initial efficacy of Mindfulness-Based Relapse Prevention (MBRP) as an adjunct to standard relapse prevention treatment (ST) for smoking cessation.
AIMS AND METHODS
Smokers (n = 86) in the maintenance phase of treatment were randomized to receive either ST plus MBRP (MBRP) (n = 44) or ST alone (ST) (n = 42). Data were collected at baseline and at 4-, 12-, and 24-week follow-up points. We evaluated the feasibility of the protocol with frequency analysis, and the efficacy with both intention to treat and complete case analyses of the effects of MBRP on abstinence. Secondary outcomes included mindfulness, craving, depression, anxiety, and positive/negative affect.
RESULTS
High adherence suggested MBRP is acceptable and feasible. Participants in the MBRP group reported increases in mindfulness (M = -7.833, p = .016), and reductions in craving (M = 17.583, p = .01) compared with the ST group. Intention to treat analysis found that, compared with MBRP (36.4%), ST (57.1%) showed trend-level superiority in abstinence at Week 4 (Prevalence Ratio = 0.63, p = .06); however at Week 24, the ST group (14.3%) demonstrated a twofold greater decrease in abstinence, compared with the MBRP group (20.1%) (Prevalence Ratio = 2.25, p = .08). Therefore, the MBRP group maintained a higher abstinence rate for longer. Reported effects were greater in the complete case analysis.
CONCLUSIONS
MBRP holds promise for preventing relapse after aided tobacco quit attempts.
IMPLICATIONS
Findings suggest that MBRP is acceptable, feasible, and valued by participants. At 24-week follow-up, there was a large effect size and a statistical trend toward fewer MBRP patients relapsing compared with ST patients. MBRP conferred ancillary benefits including reductions in craving and increases in levels of mindfulness. MBRP for tobacco cessation is highly promising and merits further research.
TRIAL REGISTRATION
clinicaltrials.gov.
IDENTIFIER
NCT02327104.",2020,"Participants in the MBRP group reported increases in mindfulness (M = -7.833, p = 0.016), and reductions in craving (M = 17.583, p = 0.01) compared to the ST group.","['Smoking', 'Smokers (n = 86) in the maintenance phase of treatment']","['ST alone (ST', 'Mindfulness-Based Relapse Prevention (MBRP', 'Mindfulness-based Relapse Prevention Program', 'MBRP', 'ST plus MBRP (MBRP']","['reductions in craving', 'abstinence', 'levels of mindfulness', 'mindfulness, craving, depression, anxiety and positive/negative affect', 'abstinence rate']","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}]",86.0,0.0270665,"Participants in the MBRP group reported increases in mindfulness (M = -7.833, p = 0.016), and reductions in craving (M = 17.583, p = 0.01) compared to the ST group.","[{'ForeName': 'Isabel Cristina', 'Initials': 'IC', 'LastName': 'Weiss de Souza', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Elisa Harumi', 'Initials': 'EH', 'LastName': 'Kozasa', 'Affiliation': 'Instituto do Cérebro, Hospital Israelita Albert Einstein, São Paulo, SP, Brazil.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'School of Graduate Psychology, Pacific University, Hillsboro, OR.'}, {'ForeName': 'Kimber P', 'Initials': 'KP', 'LastName': 'Richter', 'Affiliation': 'University of Kansas School of Medicine, Department of Preventive Medicine and Public Health, Kansas City, KS.'}, {'ForeName': 'Laisa Marcorela Andreoli', 'Initials': 'LMA', 'LastName': 'Sartes', 'Affiliation': 'Departamento de Psicologia, Universidade Federal de Juiz de Fora, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Fernando Antônio Basile', 'Initials': 'FAB', 'LastName': 'Colugnati', 'Affiliation': 'Department of Internship/Medicine School, Universidade Federal de Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Ana Regina', 'Initials': 'AR', 'LastName': 'Noto', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa057']
364,32229194,"Intraoperative tranexamic acid to decrease blood loss during myomectomy: a randomized, double-blind, placebo-controlled trial.","BACKGROUND
Myomectomy is associated with a significant risk of hemorrhage. Tranexamic acid is a synthetic lysine derivative with antifibrinolytic activity used in other surgical disciplines to reduce blood loss during surgery. However, its utility in gynecologic surgery is not well understood.
OBJECTIVE
This study aimed to determine the effect of early administration of intravenous tranexamic acid on perioperative bleeding and blood transfusion requirements in women undergoing myomectomy.
STUDY DESIGN
This study was a double-blinded, randomized, placebo-controlled trial conducted in an academic teaching hospital. Women with symptomatic fibroids thought to be at risk for large intraoperative blood loss who met the following criteria were included in the study: (1) at least 1 fibroid ≥10 cm, (2) any intramural or broad ligament fibroid ≥6 cm, and/or (3) at least 5 total fibroids based on preoperative imaging. Patients were randomized to receive a single intravenous bolus injection of tranexamic acid 15 mg/kg (intervention group) versus an intravenous bolus injection of saline of equivalent volume (placebo group) 20 minutes before the initial surgical incision. Perioperative bleeding was defined by measuring intraoperative estimated blood loss, change between pre- and postoperative hemoglobin, and frequency of blood transfusions. Estimated blood loss was calculated by combining the blood volume collected within the suction canister and the weight of used sponges. The 2 groups were compared for age; body mass index; perioperative hemoglobin and hematocrit; perioperative blood loss; duration of surgery; blood transfusion requirements; and the number, total weight, and volume of myomas removed.
RESULTS
A total of 60 patients (30 per arm) were enrolled into the study between March 1, 2015, and January 29, 2018. Age, body mass index, baseline hemoglobin and/or hematocrit, number and total weight of myomas removed, and size of myomas did not differ between arms. Of 60 patients, 32 (53%) had laparoscopic myomectomy, 24 (40%) had robotic myomectomy, and 4 (7%) had laparotomy. Median estimated blood loss was 200 mL for the tranexamic acid group and 240 mL for the placebo group (P=.88). There was no difference in median duration of surgery (165 vs 164 minutes; P=.64) or change in perioperative hemoglobin (1.00 vs 1.1 g/dL; P=.64). Patients in the tranexamic acid group did not require blood transfusions; however, 4 patients (13.3%) in the placebo group (P=.11) required blood transfusions.
CONCLUSION
Intravenous administration of tranexamic acid in patients undergoing laparoscopic or robotic myomectomies was not associated with decreased blood loss.",2020,There was no difference in median duration of surgery (165 versus 164 minutes; p=0.64) or change in perioperative hemoglobin (1.00 versus 1.1 g/dL; p=0.64).,"['Women with symptomatic fibroids thought to be at risk for large intraoperative blood loss based on the following criteria were included in the study', 'academic teaching hospital', 'patients undergoing mostly laparoscopic or robotic myomectomies', 'Sixty patients (30 per arm) were enrolled into the study between March 1, 2015 and January 29, 2018', 'women undergoing a myomectomy']","['placebo', 'Intraoperative Tranexamic Acid', 'Tranexamic acid', 'Placebo', 'tranexamic acid', 'tranexamic 15 mg/kg (intervention group) versus an intravenous bolus injection of saline of equivalent volume (placebo group) 20 minutes prior to initial surgical incision']","['intraoperative estimated blood loss, change between pre- and post-operative hemoglobin, and frequency of blood transfusions', 'body mass index, perioperative hemoglobin and hematocrit, perioperative blood loss, duration of surgery, blood transfusion requirements, and the number, total weight and volume of myomas removed', 'perioperative hemoglobin', 'blood loss', 'perioperative bleeding and blood transfusion requirements', 'Perioperative bleeding', 'blood transfusions', 'Estimated blood loss', 'median duration of surgery', 'Median estimated blood loss', 'Age, body mass index, baseline hemoglobin/hematocrit, number and total weight of myomas', 'Blood Loss']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C4255212', 'cui_str': 'Myomectomy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0195309', 'cui_str': 'Uterine Myomectomy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",,0.669796,There was no difference in median duration of surgery (165 versus 164 minutes; p=0.64) or change in perioperative hemoglobin (1.00 versus 1.1 g/dL; p=0.64).,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Opoku-Anane', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, University of California San Francisco, San Francisco, CA. Electronic address: jopokua1@gmail.com.'}, {'ForeName': 'Maria V', 'Initials': 'MV', 'LastName': 'Vargas', 'Affiliation': 'Department of Obstetrics and Gynecology, George Washington University, Washington, DC.'}, {'ForeName': 'Cherie Q', 'Initials': 'CQ', 'LastName': 'Marfori', 'Affiliation': 'Department of Obstetrics and Gynecology, George Washington University, Washington, DC.'}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Moawad', 'Affiliation': 'Department of Obstetrics and Gynecology, George Washington University, Washington, DC.'}, {'ForeName': 'Marloes S', 'Initials': 'MS', 'LastName': 'Maasen', 'Affiliation': 'Department of Obstetrics and Gynecology, George Washington University, Washington, DC.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Robinson', 'Affiliation': 'MedStar Washington Hospital Center, Georgetown University, Washington, DC.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.02.019']
365,31473189,Accrual of older adults to cancer clinical trials led by the Canadian cancer trials group - Is trial design a barrier?,"BACKGROUND
Older adults (OA), aged 65 years and over, are under-represented in studies. Strict exclusion criteria have been identified as a potential barrier to accrual of OA. This study aims to determine: 1) whether accrual of OA to trials led by the Canadian Cancer Trials Group (CCTG) has increased since 2003; 2) whether exclusion criteria have broadened over time; 3) whether exclusion criteria are associated with lower accrual of OA.
MATERIALS AND METHODS
Phase III and randomized phase II CCTG-led trials initiated from 1990 onwards were included. Trial protocols were reviewed for exclusion criteria. Associations between trial characteristics and percentage of OA accrued were compared using multivariate linear regression modelling. The frequency of exclusion criteria in trials initiated pre- and post-2003 was compared using the Chi-Square test or Fisher exact test.
RESULTS
Sixty-nine trials involving 34,957 patients were included. Accrual of OA to trials remained low compared to OA diagnosed with cancer in Canada (40.8% vs. 56.1%, p < .001). There was a small increase in the accrual of OA since 2003 (42.8% vs. 39.3%, p = .04). There was no relaxation of exclusion criteria over time. Studies initiated prior to 2003, breast cancer studies and studies with exclusion criteria based on renal dysfunction were associated with lower accrual of OA (p < .05). Central nervous system studies were associated with higher accrual of OA (p = .03).
CONCLUSION
OA remain under-represented in trials. While there has been minimal change in exclusion criteria over time, renal dysfunction was the only exclusion criteria associated with lower accrual of OA.",2020,"Central nervous system studies were associated with higher accrual of OA (p = .03).
","['older adults', 'Older adults (OA), aged 65\u202fyears and over, are under-represented in studies', 'Sixty-nine trials involving 34,957 patients were included', 'Phase III and randomized phase II CCTG-led trials initiated from 1990 onwards were included']",[],['accrual of OA since'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",[],[],,0.0585006,"Central nervous system studies were associated with higher accrual of OA (p = .03).
","[{'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Hernandez-Torres', 'Affiliation': 'Division of Medical Oncology, Ottawa General Hospital, University of Ottawa, 501 Smyth Road, Ottawa, ON K1H 8L6, Canada.'}, {'ForeName': 'Winson Y', 'Initials': 'WY', 'LastName': 'Cheung', 'Affiliation': 'Department of Oncology, Tom Baker Cancer Centre, University of Calgary, 1331 29 ST NW, Calgary, AB T2N 4N2, Canada.'}, {'ForeName': 'Shiying', 'Initials': 'S', 'LastName': 'Kong', 'Affiliation': 'Department of Oncology, Tom Baker Cancer Centre, University of Calgary, 1331 29 ST NW, Calgary, AB T2N 4N2, Canada.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': ""O'Callaghan"", 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, 10 Stuart Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Hsu', 'Affiliation': 'Division of Medical Oncology, Ottawa General Hospital, University of Ottawa, 501 Smyth Road, Ottawa, ON K1H 8L6, Canada. Electronic address: thsu@toh.on.ca.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2019.08.004']
366,32228379,Acute Exenatide Therapy Attenuates Postprandial Vasodilation in Humans with Prediabetes: A Randomized Controlled Trial.,"Background: The state of prediabetes comprises atherosclerotic changes leading to decreased vascular function in humans. This study examined the effects on incretin mimetics on vascular physiology in the prediabetic postprandial state. Methods: Fifteen obese adults with prediabetes participated in a randomized, crossover, double-blinded trial comparing the postprandial effects of exenatide, saxagliptin, and placebo on peripheral vasodilation. All studies utilized a standardized high-fat meal. Resting and peak forearm blood flow (FBF) were measured via strain gauge venous occlusion plethysmography, and makers of vascular dysfunction were measured in plasma. Results: Exenatide attenuated resting FBF at 3 hr ( P = 0.003) and 6 hr ( P = 0.056) postmeal, compared to placebo. Nonsignificant reductions in resting FBF were observed between saxagliptin and placebo at the same time points. No group differences were observed for peak FBF, plasma nitrotyrosine, and plasma 8-iso-prostaglandin F2alpha. A transient increase in plasma triglyceride was abated in the exenatide group, when compared to saxagliptin and placebo groups. Only exenatide group showed no significant upsurge in plasma insulin. Plasma-free fatty acids significantly declined in all three groups, although less markedly for exenatide. Postmeal glucose increased at 2 hr with placebo and saxagliptin, but simultaneously decreased with exenatide. Conclusions: Acute treatment with exenatide blunted the postprandial vasodilatory effect of a high-fat meal in prediabetes. Exenatide's acute effects derived primarily from multiple endothelium-independent processes. Trial Registration Number: NCT02104739.",2020,"No group differences were observed for peak FBF, plasma nitrotyrosine, and plasma 8-iso-prostaglandin F2alpha.","['Fifteen obese adults with prediabetes participated', 'humans', 'Humans with Prediabetes']","['placebo', 'exenatide', 'placebo and saxagliptin', 'Acute Exenatide Therapy', 'Exenatide', 'saxagliptin and placebo', 'saxagliptin', 'exenatide, saxagliptin, and placebo']","['Plasma-free fatty acids', 'peak FBF, plasma nitrotyrosine, and plasma 8-iso-prostaglandin F2alpha', 'plasma insulin', 'resting FBF', 'Postmeal glucose', 'strain gauge venous occlusion plethysmography, and makers of vascular dysfunction', 'Resting and peak forearm blood flow (FBF', 'Postprandial Vasodilation', 'plasma triglyceride']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0373606', 'cui_str': 'Free fatty acids measurement (procedure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0047645', 'cui_str': 'nitrotyrosine'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0012471', 'cui_str': 'prostaglandin F2 alpha'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C0430494', 'cui_str': 'Venous occlusion plethysmography (procedure)'}, {'cui': 'C0554244', 'cui_str': 'Maker (occupation)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}]",15.0,0.263025,"No group differences were observed for peak FBF, plasma nitrotyrosine, and plasma 8-iso-prostaglandin F2alpha.","[{'ForeName': 'Vala', 'Initials': 'V', 'LastName': 'Hamidi', 'Affiliation': 'Department of Medicine, Division of Endocrinology, University of California, San Diego, California, USA.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Riggs', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern, Dallas, Texas, USA.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolism, The University of Texas Health Science Center, Houston, Texas, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Bermudez Saint Andre', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Houston Methodist, Houston, Texas, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Westby', 'Affiliation': 'NASA Johnson Space Center, Houston, Texas, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Coverdale', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolism, The University of Texas Health Science Center, Houston, Texas, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Dursteler', 'Affiliation': 'Department of Internal Medicine, University of California Los Angeles-Olive View, Los Angeles, California, USA.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolism, The University of Texas Health Science Center, Houston, Texas, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Miller Iii', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolism, The University of Texas Health Science Center, Houston, Texas, USA.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Taegtmeyer', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolism, The University of Texas Health Science Center, Houston, Texas, USA.'}, {'ForeName': 'Absalon D', 'Initials': 'AD', 'LastName': 'Gutierrez', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolism, The University of Texas Health Science Center, Houston, Texas, USA.'}]",Metabolic syndrome and related disorders,['10.1089/met.2019.0102']
367,31279749,The impact of comprehensive geriatric assessment for optimal treatment of older patients with cancer: A randomized parallel-group clinical trial.,"OBJECTIVES
The aim was to investigate if oncologic treatment decision based on G8 screening followed by comprehensive geriatric assessment (CGA) and a multidisciplinary team conference in patients with G8 ≤ 14 was better than treatment decision based on standard assessment. ClinicalTrials.gov Identifier: NCT02671994.
MATERIALS AND METHODS
From January 2016 to June 2018, 96 patients with cancer, aged ≥70 years, were included. Patients were randomized to treatment decision based on the oncologist's clinical judgement (control) or based on screening with G8. If G8 > 14 treatment decision was made as in the control group and if G8 ≤ 14, patients were referred to CGA including intervention as needed and treatment decision after a multidisciplinary team conference (MDT).
RESULTS
The study was closed early. 47 patients were randomized to the control group and 49 to the intervention group; 28 had a G8 ≤ 14, 24 of whom attended CGA. In the intervention group 48% completed treatment as planned compared to 54% in the control group (p = .208). Thirty-eight percent experienced grade 3-4 toxicity in the control group compared with only 20% in the intervention group (p = .055). Median overall survival (OS) was 14.2 months in the control group and 19.1 months in the intervention group (p = .911). Median progression-free survival (PFS) was 9.0 months in the control group and 7.8 months for the intervention group (p = .838).
CONCLUSION
Treatment decision based on G8 screening followed by CGA had no impact on completion rate of planned oncologic treatment, OS or PFS, but resulted in a borderline significant lower incidence of grade 3-4 toxicity.",2020,In the intervention group 48% completed treatment as planned compared to 54% in the control group (p = .208).,"['47 patients were randomized to the control group and 49 to the intervention group; 28 had a G8\u202f≤\u202f14, 24 of whom attended CGA', 'older patients with cancer', 'From January 2016 to June 2018, 96 patients with cancer, aged ≥70\u202fyears', 'patients with G8\u202f≤\u202f14 was better than treatment decision based on standard assessment']","[""oncologist's clinical judgement (control) or based on screening with G8"", 'comprehensive geriatric assessment', 'G8 screening followed by comprehensive geriatric assessment (CGA']","['Median overall survival (OS', 'completion rate of planned oncologic treatment, OS or PFS', 'grade 3-4 toxicity', 'Median progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0017463', 'cui_str': 'Geriatric Assessment'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205478', 'cui_str': 'Oncologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",96.0,0.0642279,In the intervention group 48% completed treatment as planned compared to 54% in the control group (p = .208).,"[{'ForeName': 'Sambavy', 'Initials': 'S', 'LastName': 'Nadaraja', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark; Institute of Clinical Research, University of Southern Denmark, Odense, Denmark. Electronic address: sambavy.nadaraja@rsyd.dk.'}, {'ForeName': 'Lars-Erik', 'Initials': 'LE', 'LastName': 'Matzen', 'Affiliation': 'Department of Geriatric Medicine, Odense University Hospital, Odense, Denmark. Electronic address: lars.matzen@rsyd.dk.'}, {'ForeName': 'Trine Lembrecht', 'Initials': 'TL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark. Electronic address: trine.joergensen@rsyd.dk.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Dysager', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark. Electronic address: lars.dysager@rsyd.dk.'}, {'ForeName': 'Anja Ør', 'Initials': 'AØ', 'LastName': 'Knudsen', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark. Electronic address: anja.oer.knudsen@rsyd.dk.'}, {'ForeName': 'Stefan Starup', 'Initials': 'SS', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark. Electronic address: stefan.jeppesen@rsyd.dk.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Möller', 'Affiliation': 'OPEN - Odense Patient data Explorative Network, Odense University Hospital and Department of Clinical Research, University of Southern Denmark, Denmark. Electronic address: soren.moller@rsyd.dk.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Herrstedt', 'Affiliation': 'Department of Clinical Oncology, Zealand University Hospital, Roskilde, Denmark. Electronic address: jherr@regionsjaelland.dk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of geriatric oncology,['10.1016/j.jgo.2019.06.019']
368,31386219,Bayesian inference for a principal stratum estimand to assess the treatment effect in a subgroup characterized by postrandomization event occurrence.,"The treatment effect in subgroups of patients is often of interest in randomized controlled clinical trials, as this may provide useful information on how to treat which patients best. When a specific subgroup is characterized by the absence of certain events that happen postrandomization, a naive analysis on the subset of patients without these events may be misleading. The principal stratification framework allows one to define an appropriate causal estimand in such settings. Statistical inference for the principal stratum estimand hinges on scientifically justified assumptions, which can be included with Bayesian methods through prior distributions. Our motivating example is a large randomized placebo-controlled trial of siponimod in patients with secondary progressive multiple sclerosis. The primary objective of this trial was to demonstrate the efficacy of siponimod relative to placebo in delaying disability progression for the whole study population. However, the treatment effect in the subgroup of patients who would not relapse during the trial is relevant from both a scientific and patient perspective. Assessing this subgroup treatment effect is challenging as there is strong evidence that siponimod reduces relapses. We describe in detail the scientific question of interest, the principal stratum estimand, the corresponding analysis method for binary endpoints, and sensitivity analyses. Although our work is motivated by a randomized clinical trial, the approach has broader appeal and could be adapted for observational studies.",2019,"Statistical inference for the principal stratum estimand hinges on scientifically justified assumptions, which can be included with Bayesian methods through prior distributions.",['patients with secondary progressive multiple sclerosis'],['placebo'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751965', 'cui_str': 'Multiple Sclerosis, Secondary Progressive'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.216743,"Statistical inference for the principal stratum estimand hinges on scientifically justified assumptions, which can be included with Bayesian methods through prior distributions.","[{'ForeName': 'Baldur P', 'Initials': 'BP', 'LastName': 'Magnusson', 'Affiliation': 'Biostatistics and Pharmacometrics, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Schmidli', 'Affiliation': 'Biostatistics and Pharmacometrics, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rouyrre', 'Affiliation': 'Biostatistics and Pharmacometrics, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Daniel O', 'Initials': 'DO', 'LastName': 'Scharfstein', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",Statistics in medicine,['10.1002/sim.8333']
369,32149425,Effects of simple active referrals of different intensities on smoking abstinence and smoking cessation services attendance: a cluster-randomized clinical trial.,"BACKGROUND AND AIMS
Proactive brief cessation advice by a lay counsellor combined with a referral to a smoking cessation service (active referral) is effective in increasing service use and quitting in community smokers. We compared the effect of two modified approaches to referrals on the cessation outcomes in community smokers.
DESIGN
Three-arm cluster-randomized trial.
SETTING
General community in Hong Kong.
PARTICIPANTS
Daily cigarette smokers (n = 1163; 77.7% male).
INTERVENTIONS
Participants were randomized to receive on-site active referral (OSR, n = 395), where lay counsellors helped participants make appointments with a smoking cessation service of their choice plus tailored reminders; mobile text messaging referral (TMR, n = 385), where participants were encouraged to use a smoking cessation service via text messages; or brief cessation advice only (control, n = 383).
MEASUREMENTS
The primary outcome was a self-reported 7-day point-prevalence abstinence at 6 months post-treatment initiation. Secondary outcomes included 7-day point-prevalence abstinence at 3 and 18 months, biochemically validated abstinence, smoking reduction and the use of cessation services at 3, 6 and 18 months.
FINDINGS
Using intention-to-treat analysis, the OSR (17.7%) and TMR (17.1%) groups had significantly higher self-reported abstinence than the control (12.0%) group at 6 months [odds ratio (OR) for OSR versus control = 1.58, 95% confidence interval (CI) = 1.06-2.36; OR for TMR versus control = 1.52, 95% CI = 1.01-2.28; both P < 0.05]. The corresponding validated abstinence rates at 6 months were 7.6, 7.8 and 3.9% (OR for TMR versus control = 2.02, 95% CI = 1.07-3.81; OR for TMR versus control = 2.07, 95% CI = 1.10-3.92; both P < 0.05). Self-reported and validated abstinence were similar at 18 months. OSR groups had higher rates of smoking cessation service use than the control group at all follow-ups (all P < 0.001). The smoking reduction rates were similar in continuing smokers.
CONCLUSIONS
Simple active referrals (in person or via text messaging) to smoking cessation services increased abstinence rates among smokers in Hong Kong compared with general brief cessation advice. On-site active referral increased the use of smoking cessation services compared with general brief cessation advice.",2020,OSR groups had higher rates of smoking cessation service use than the control group at all follow-ups (all P < 0.001).,"['community smokers', 'General community in Hong Kong', 'Daily cigarette smokers (n\xa0=\xa01163; 77.7% male']","['site active referral (OSR, n\xa0=\xa0395), where lay counsellors helped participants make appointments with a smoking cessation service of their choice plus tailored reminders; mobile text messaging referral (TMR, n\xa0=\xa0385), where participants were encouraged to use a smoking cessation service via text messages; or brief cessation advice only (control, n\xa0=\xa0383']","['rates of smoking cessation service', 'OSR', 'self-reported 7-day point-prevalence abstinence', 'abstinence rates', 'smoking reduction rates', '7-day point-prevalence abstinence at 3 and 18\xa0months, biochemically validated abstinence, smoking reduction and the use of cessation services', 'TMR', 'smoking abstinence and smoking cessation services attendance']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C4517751', 'cui_str': 'Three hundred and eighty-five'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1720467', 'cui_str': 'Only'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",,0.162331,OSR groups had higher rates of smoking cessation service use than the control group at all follow-ups (all P < 0.001).,"[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'School of Nursing, the University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Tzu Tsun', 'Initials': 'TT', 'LastName': 'Luk', 'Affiliation': 'School of Nursing, the University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Yi Nam', 'Initials': 'YN', 'LastName': 'Suen', 'Affiliation': 'Department of Psychiatry, the University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Yongda', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'School of Nursing, the University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Ho Cheung William', 'Initials': 'HCW', 'LastName': 'Li', 'Affiliation': 'School of Nursing, the University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Yee Tak Derek', 'Initials': 'YTD', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, the University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Antonio Cho Sshing', 'Initials': 'ACS', 'LastName': 'Kwong', 'Affiliation': 'Hong Kong Council on Smoking and Health, Pokfulam, Hong Kong.'}, {'ForeName': 'Vienna Wai Yin', 'Initials': 'VWY', 'LastName': 'Lai', 'Affiliation': 'Hong Kong Council on Smoking and Health, Pokfulam, Hong Kong.'}, {'ForeName': 'Sophia Siu Chee', 'Initials': 'SSC', 'LastName': 'Chan', 'Affiliation': 'School of Nursing, the University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Tai-Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, the University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, the University of Hong Kong, Pokfulam, Hong Kong.'}]","Addiction (Abingdon, England)",['10.1111/add.15029']
370,32232481,Prognostic value of interim FDG-PET in diffuse large cell lymphoma: results from the CALGB 50303 Clinical Trial.,"As part of a randomized, prospective clinical trial in large cell lymphoma, we conducted serial fluorodeoxyglucose positron emission tomography (FDG-PET) at baseline, after 2 cycles of chemotherapy (interim PET [i-PET]), and at end of treatment (EoT) to identify biomarkers of response that are predictive of remission and survival. Scans were interpreted in a core laboratory by 2 imaging experts, using the visual Deauville 5-point scale (5-PS), and by calculating percent change in FDG uptake (change in standardized uptake value [ΔSUV]). Visual scores of 1 through 3 and ΔSUV ≥66% were prospectively defined as negative. Of 524 patients enrolled in the parent trial, 169 agreed to enroll in the PET substudy and 158 were eligible for final analysis. In this selected population, all had FDG-avid disease at baseline; by 5-PS, 55 (35%) remained positive on i-PET and 28 (18%) on EoT PET. Median ΔSUV on i-PET was 86.2%. With a median follow-up of 5 years, ΔSUV, as continuous variable, was associated with progression-free survival (PFS) (hazard ratio [HR] = 0.99; 95% confidence interval [CI], 0.97-1.00; P = .02) and overall survival (OS) (HR, 0.98; 95% CI, 0.97-0.99; P = .03). ΔSUV ≥66% was predictive of OS (HR, 0.31; 95% CI, 0.11-0.85; P = .02) but not PFS (HR, 0.47; 95% CI, 0.19-1.13; P = .09). Visual 5-PS on i-PET did not predict outcome. ΔSUV, but not visual analysis, on i-PET predicted OS in DLBCL, although the low number of events limited the statistical analysis. These data may help guide future clinical trials using PET response-adapted therapy. This trial was registered at www.clinicaltrials.gov as #NCT00118209.",2020,Visual 5-PS on i-PET did not predict outcome.,"['Large Cell Lymphoma', '524 patients enrolled in the parent trial, 169 agreed to enroll in the PET substudy and 158 were eligible for final analysis']",[],"['predictive of OS', 'overall survival (OS', 'FDG uptake (ΔSUV', 'Median ΔSUV', 'Visual scores', 'visual 5-point scale (5-PS', 'progression-free survival (PFS']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",524.0,0.472593,Visual 5-PS on i-PET did not predict outcome.,"[{'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Schöder', 'Affiliation': 'Department Radiology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Mei-Yin C', 'Initials': 'MC', 'LastName': 'Polley', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Knopp', 'Affiliation': 'Department Radiology, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Hall', 'Affiliation': 'Department Radiology, Philadelphia VA Medical Center, Philadelphia, PA.'}, {'ForeName': 'Lale', 'Initials': 'L', 'LastName': 'Kostakoglu', 'Affiliation': 'Department Radiology, Mt. Sinai Medical Center, New York, NY.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department Radiology, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Howard R', 'Initials': 'HR', 'LastName': 'Higley', 'Affiliation': 'CCS Associates, Inc., San Jose, CA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Kelloff', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Rockville, MD.'}, {'ForeName': 'Heshan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': 'Department Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Department Medicine, MedStar Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wagner-Johnston', 'Affiliation': 'Department Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': 'Department Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': 'Department Medicine, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': 'Department Laboratory Medicine, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Department Medicine, Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Schwartz', 'Affiliation': 'Department Radiology, Columbia University Medical Center, New York, NY; and.'}, {'ForeName': 'Wyndham H', 'Initials': 'WH', 'LastName': 'Wilson', 'Affiliation': 'Lymphoid Malignancies Branch, National Cancer Institute, National Institutes of Health, Rockville, MD.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Department Medicine, Washington University School of Medicine, St. Louis, MO.'}]",Blood,['10.1182/blood.2019003277']
371,31537194,Blood Pressure Variability and Cardiovascular Outcomes in Patients With Prior Stroke: A Secondary Analysis of PRoFESS.,"Background and Purpose- Every year in the United States, almost 185 000 ischemic strokes occur in patients with a prior stroke. Recurrent stroke has significantly higher morbidity and mortality. Among modifiable risk factors for recurrent stroke, hypertension is the most prevalent. Reducing systolic blood pressure is standard of care for secondary stroke prevention. Recent literature suggests that increased blood pressure variability (BPV) is associated with primary stroke, although studies have not convincingly shown that it is associated with recurrent stroke, which was the goal of this analysis. Methods- We conducted a secondary analysis of 17 916 patients in the PRoFESS (Prevention Regimen for Effectively Avoiding Second Strokes) trial, which is the largest trial of patients with potential recurrent stroke. We calculated BPV and evaluated its effect on recurrent stroke (composite and stratified by ischemic or hemorrhagic stroke), major cardiovascular events (death from cardiovascular causes, recurrent stroke, myocardial infarction, or new or worsening heart failure), and all-cause death. Results- Both systolic and diastolic BPV were associated with recurrent stroke, major cardiovascular events, and all-cause death. The association with stroke was significant for ischemic, but not hemorrhagic, stroke. For every 10-point increase in BPV (systolic SD, range =0-54.2), the hazard ratio for a recurrent ischemic stroke was 1.15 (95% CI, 1.02-1.32; P =0.02), for major cardiovascular events was 1.19 (95% CI, 1.09-1.31; P <0.001), and for all-cause death was 1.24 (95% CI, 1.10-1.39; P <0.001). Conclusions- Our study adds to the growing body of literature suggesting that BPV is an important and potentially modifiable risk factor for ischemic stroke, cardiovascular events, and all-cause death. Specifically, it is the first study to demonstrate that increased BPV is associated with recurrent ischemic stroke and that diastolic BPV can be as important as systolic BPV. Future work should focus on evaluating whether actively reducing BPV, using widely available and inexpensive antihypertensive medications, reduces the risk of cardiovascular disease.",2019,"The association with stroke was significant for ischemic, but not hemorrhagic, stroke.","['17\u2009916 patients in the PRoFESS (Prevention Regimen for Effectively Avoiding Second Strokes) trial, which is the largest trial of patients with potential recurrent stroke', 'Patients']","[' and Purpose', 'Methods', 'Conclusions']","['major cardiovascular events', 'BPV', 'recurrent stroke (composite and stratified by ischemic or hemorrhagic stroke), major cardiovascular events (death from cardiovascular causes, recurrent stroke, myocardial infarction, or new or worsening heart failure), and all-cause death. Results', 'systolic blood pressure', 'recurrent stroke, major cardiovascular events', 'morbidity and mortality', 'blood pressure variability (BPV', 'hazard ratio for a recurrent ischemic stroke', 'systolic and diastolic BPV', 'Blood Pressure Variability and Cardiovascular Outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",,0.151981,"The association with stroke was significant for ischemic, but not hemorrhagic, stroke.","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'de Havenon', 'Affiliation': 'From the Department of Neurology (A.d.H., B.J., K.-H.W., J.J.M.), University of Utah, Salt Lake City.'}, {'ForeName': 'Nora F', 'Initials': 'NF', 'LastName': 'Fino', 'Affiliation': 'Division of Epidemiology, Department of Internal Medicine (N.F.F.), University of Utah, Salt Lake City.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Johnson', 'Affiliation': 'From the Department of Neurology (A.d.H., B.J., K.-H.W., J.J.M.), University of Utah, Salt Lake City.'}, {'ForeName': 'Ka-Ho', 'Initials': 'KH', 'LastName': 'Wong', 'Affiliation': 'From the Department of Neurology (A.d.H., B.J., K.-H.W., J.J.M.), University of Utah, Salt Lake City.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Majersik', 'Affiliation': 'From the Department of Neurology (A.d.H., B.J., K.-H.W., J.J.M.), University of Utah, Salt Lake City.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tirschwell', 'Affiliation': 'Department of Neurology, University of Washington, Seattle (D.T.).'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Rost', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston (N.R.).'}]",Stroke,['10.1161/STROKEAHA.119.026293']
372,32227247,Isradipine Versus Placebo in Early Parkinson Disease: A Randomized Trial.,"Background
Studies suggest that dihydropyridine calcium-channel blockers may be associated with reduced risk for Parkinson disease (PD).
Objective
To assess the effect of isradipine, a dihydropyridine calcium-channel blocker, on the rate of clinical progression of PD.
Design
Multicenter, randomized, parallel-group, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT02168842).
Setting
57 Parkinson Study Group sites in North America.
Participants
Patients with early-stage PD (duration <3 years) who were not taking dopaminergic medications at enrollment.
Intervention
5 mg of immediate-release isradipine twice daily or placebo for 36 months.
Measurements
The primary outcome was change in the Unified Parkinson's Disease Rating Scale (UPDRS) parts I to III score measured in the antiparkinson medication ""ON"" state between baseline and 36 months. Secondary outcomes included time to initiation and use of antiparkinson medications, time to onset of motor complications, change in nonmotor disability, and quality-of-life measures.
Results
336 patients were randomly assigned (mean age, 62 years [SD, 9]; 68% men; disease duration, 0.9 year [SD, 0.7]; mean UPDRS part I to III score, 23.1 [SD, 8.6]); 95% of patients completed the study. Adjusted least-squares mean changes in total UPDRS score in the antiparkinson medication ON state over 36 months for isradipine and placebo recipients were 2.99 (95% CI, 0.95 to 5.03) points versus 3.26 (CI, 1.25 to 5.26) points, respectively, with a treatment effect of -0.27 (CI, -3.02 to 2.48) point (P = 0.85). Statistical adjustment for antiparkinson medication use did not change the findings. Secondary outcomes showed no effect of isradipine treatment. The most common adverse effects of isradipine were edema and dizziness.
Limitation
The isradipine dose may have been insufficient to engage the target calcium channels associated with neuroprotective effects.
Conclusion
Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
Primary Funding Source
National Institute of Neurological Disorders and Stroke.",2020,"Conclusion
Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
","['336 patients were randomly assigned (mean age, 62 years [SD, 9]; 68% men; disease duration, 0.9 year [SD, 0.7]; mean UPDRS part I to III score, 23.1 [SD, 8.6]); 95% of patients completed the study', 'Participants\n\n\nPatients with early-stage PD (duration <3 years) who were not taking dopaminergic medications at enrollment', 'Setting\n\n\n57 Parkinson Study Group sites in North America', 'Early Parkinson Disease']","['dihydropyridine calcium-channel blocker', 'placebo', 'dihydropyridine calcium-channel blockers', 'isradipine', 'Intervention\n\n\n5 mg of immediate-release isradipine twice daily or placebo', 'Isradipine Versus Placebo']","[""Unified Parkinson's Disease Rating Scale (UPDRS) parts"", 'time to initiation and use of antiparkinson medications, time to onset of motor complications, change in nonmotor disability, and quality-of-life measures', 'total UPDRS score', 'edema and dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0220821', 'cui_str': 'dihydropyridine'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1153433', 'cui_str': 'Calcium channel'}, {'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",336.0,0.515182,"Conclusion
Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-2534']
373,32227309,"The Effect of Streptococcus salivarius K12 on Halitosis: a Double-Blind, Randomized, Placebo-Controlled Trial.","This study was to evaluate the effect of Streptococcus salivarius K12 on tongue coating-associated halitosis. Twenty-eight subjects having tongue coating-associated halitosis were randomly divided into either a test or control group. For each of the 30 days, the test subjects sucked S. salivarius K12 tablet while the control subjects sucked placebo tablets. All the subjects did not take physical (tongue scraping) and chemical (antiseptic mouth-rinse) oral cavity pretreatment prior to use of the tablets. At baseline, and on the 1st, 7th, and 14th day after completing the course of tablets, the subjects were assessed for their organoleptic test (OLT) scores, volatile sulfur compound (VSC) levels, and tongue coating scores (TCS). During the course, all subjects kept their routine oral care habits without scraping their tongue coating. Plaque index, probing depth, and bleeding index were recorded at baseline and at the completion of the trial. On the 1st day following the end of tablet use, the OLT scores and VSC levels had significantly decreased in the test group when compared with the baseline values (P = 0.001 and P = 0.012). The TCS in the test group were also significantly decreased (P = 0.05). At days 7 and 14, the OLT scores in the test group were still significantly lower than the baseline levels (P = 0.006 and P = 0.039 respectively). However, there were no statistical differences with OLT, VSC, and TCS between the test group and the placebo group by analysis of multi-level regression model. The use of S. salivarius K12 did not have significant effect on halitosis with tongue coating cause when the tongue coating was not physically or chemically pre-treated, which implies removing tongue coating is required before Streptococcus salivarius K12 use.",2020,"However, there were no statistical differences with OLT, VSC, and TCS between the test group and the placebo group by analysis of multi-level regression model.",['Twenty-eight subjects having tongue coating-associated halitosis'],"['Placebo', 'placebo', 'Streptococcus salivarius K12']","['Plaque index, probing depth, and bleeding index', 'OLT scores', 'organoleptic test (OLT) scores, volatile sulfur compound (VSC) levels, and tongue coating scores (TCS', 'Halitosis', 'OLT scores and VSC levels', 'OLT, VSC, and TCS']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0009144', 'cui_str': 'Furred tongue (disorder)'}, {'cui': 'C0018520', 'cui_str': 'Halitosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0318179', 'cui_str': 'Streptococcus salivarius'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1963547', 'cui_str': 'Volatile'}, {'cui': 'C0682919', 'cui_str': 'sulfur compounds'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0018520', 'cui_str': 'Halitosis'}]",,0.061357,"However, there were no statistical differences with OLT, VSC, and TCS between the test group and the placebo group by analysis of multi-level regression model.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Periodontology, Peking University School and Hospital of Stomatology, Beijing, 100081, People's Republic of China.""}, {'ForeName': 'Hongjiang', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Department of Periodontology, Peking University School and Hospital of Stomatology, Beijing, 100081, People's Republic of China.""}, {'ForeName': 'Ziyuan', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Department of Periodontology, Peking University School and Hospital of Stomatology, Beijing, 100081, People's Republic of China.""}, {'ForeName': 'Xiangying', 'Initials': 'X', 'LastName': 'Ouyang', 'Affiliation': ""Department of Periodontology, Peking University School and Hospital of Stomatology, Beijing, 100081, People's Republic of China. kqouyangxy@bjmu.edu.cn.""}]",Probiotics and antimicrobial proteins,['10.1007/s12602-020-09646-7']
374,32224029,Postcraniectomy pain: comparison between 2 incisions for the retrosigmoid approach. Prospective randomized study.,"BACKGROUND
Suboccipital lateral approach is a common practice in neurosurgery to expose the region of the cerebellopontine angle. Postcraniectomy headache (PCH) is one of the most frequent complications that diminish the quality of life of patients.
OBJECTIVE
To compare postcraniectomy pain in patients operated on for vestibular neurinomas by a suboccipital lateral approach by 2 different incisions.
MATERIAL AND METHODS
Prospective randomized research study. Follow-up of patients operated for vestibular neurinomas between July 2017 and May 2019 (n=40) by the same surgeon. One group received the classical linear incision (n=20) and another group the alternative incision in an inverted ""U"" (modified Dandy) (n=20). Pain intensity was evaluated by numerical scale. A minimum follow-up of 3 months was carried out. The impact on quality of life was measured by the SF-36 questionnaire short version both before and after surgery.
RESULTS
The average age was 46.1 years. The overall PCH index was 27.5% (n=11) of the patients. The incidence of pain in the group that received the classical incision (A) was 20% (n=4) and in group B was 35% (n=7).
CONCLUSIONS
We found a higher rate of post-craniectomy headache in patients who underwent a ""modified Dandy"" incision. These are preliminary data of an undergoing study and we hope to obtain more representative information in the future. We recommend interdisciplinary follow up for the integral treatment of PCH.",2020,"The incidence of pain in the group that received the classical incision (A) was 20% (n=4) and in group B was 35% (n=7).
","['patients who underwent a ""modified Dandy"" incision', 'patients operated on for vestibular neurinomas by a suboccipital lateral approach by 2 different incisions', 'patients operated for vestibular neurinomas between July 2017 and May 2019 (n=40) by the same surgeon']","['classical linear incision (n=20) and another group the alternative incision in an inverted ""U"" (modified Dandy', 'classical incision']","['incidence of pain', 'overall PCH index', 'higher rate of post-craniectomy headache', 'quality of life', 'Pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0027809', 'cui_str': 'Neurinoma'}, {'cui': 'C0442187', 'cui_str': 'Suboccipital approach (qualifier value)'}, {'cui': 'C0205514', 'cui_str': 'Lateral approach (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]","[{'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4522321', 'cui_str': 'Inverted (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0195897', 'cui_str': 'Craniectomy'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0034380'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.0290777,"The incidence of pain in the group that received the classical incision (A) was 20% (n=4) and in group B was 35% (n=7).
","[{'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Lorefice', 'Affiliation': 'Departamento de Neurocirugía, FLENI, Buenos Aires, Argentina. Electronic address: elorefice@fleni.org.ar.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Marcó Del Pont', 'Affiliation': 'Departamento de Neurocirugía, FLENI, Buenos Aires, Argentina.'}, {'ForeName': 'Sebastián J M', 'Initials': 'SJM', 'LastName': 'Giovannini', 'Affiliation': 'Departamento de Neurocirugía, FLENI, Buenos Aires, Argentina.'}, {'ForeName': 'Sol', 'Initials': 'S', 'LastName': 'Cavanagh', 'Affiliation': 'Departamento de Neurología, Clínica de cefalea, FLENI, Buenos Aires, Argentina.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Goicochea', 'Affiliation': 'Departamento de Neurología, Clínica de cefalea, FLENI, Buenos Aires, Argentina.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Cervio', 'Affiliation': 'Departamento de Neurocirugía, FLENI, Buenos Aires, Argentina.'}]","Neurocirugia (Asturias, Spain)",['10.1016/j.neucir.2020.01.003']
375,31863530,Contingency management treatment for methamphetamine use disorder in South Africa.,"INTRODUCTION AND AIMS
As South Africa, especially the Western Cape Province, faces an epidemic of methamphetamine use disorder, therapeutic approaches suited to the South African context are needed. This secondary analysis assessed retention and methamphetamine abstinence outcomes in response to an 8-week pilot contingency management (CM) intervention trial of neural correlates of methamphetamine abstinence, exploring sociodemographic and clinical differences between responders and non-responders.
DESIGN AND METHODS
Research participants provided thrice-weekly monitored urine samples, which were analysed by qualitative radioimmunoassay. The primary outcome for this analysis was therapeutic response, defined as abstinence from methamphetamine (≥23 of 24 possible methamphetamine-negative urine samples).
RESULTS
Data from 30 adults living in Cape Town, South Africa (34 ± 6.1 years of age, mean age ± SD, 21 men) were included. Sixty-three percent (12 men) were responders. In bivariate comparisons, baseline measurements showed fewer responders reported monthly household income ≥25 000+ South African Rand (ZAR; ~USD $1880; vs. ZAR < 25 000) than non-responders (15.8% vs. 63.6%; P = 0.007). Furthermore, responders had higher median years of education (12 vs. 10; Kruskal-Wallis χ 2 = 4.25, DF = 1, P = 0.039) and lower median body mass index than non-responders (19 vs. 24; Kruskal-Wallis χ 2 = 6.84, P = 0.008).
DISCUSSION AND CONCLUSIONS
Therapeutic response in this study were comparable to those obtained with CM for methamphetamine use disorder in North America and Europe. Our findings suggest that CM may be a useful component of treatment strategies to boost retention and continuous abstinence from methamphetamine in Cape Town, South Africa. Larger efficacy studies are needed in this setting.",2020,"Furthermore, responders had higher median years of education (12 vs. 10; Kruskal-Wallis χ 2 = 4.25, DF = 1, P = 0.039) and lower median body mass index than non-responders (19 vs. 24; Kruskal-Wallis χ 2 = 6.84, P = 0.008).
","['30 adults living in Cape Town, South Africa (34\u2009±\u20096.1\u2009years of age, mean age\u2009±\u2009SD, 21 men) were included', 'methamphetamine use disorder in South Africa', 'Sixty-three percent (12 men) were responders']",[],"['median body mass index', 'therapeutic response, defined as abstinence from methamphetamine (≥23 of 24 possible methamphetamine-negative urine samples', 'median years of education']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",30.0,0.228972,"Furthermore, responders had higher median years of education (12 vs. 10; Kruskal-Wallis χ 2 = 4.25, DF = 1, P = 0.039) and lower median body mass index than non-responders (19 vs. 24; Kruskal-Wallis χ 2 = 6.84, P = 0.008).
","[{'ForeName': 'Chukwuemeka N', 'Initials': 'CN', 'LastName': 'Okafor', 'Affiliation': 'Division of Infectious Diseases, David Geffen School of Medicine at University of California, Los Angeles, USA.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dannatt', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ipser', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'van Nunen', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Marilyn T', 'Initials': 'MT', 'LastName': 'Lake', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Krishnamurti', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh School of Medicine, University of Pittsburgh, Pittsburgh, USA.'}, {'ForeName': 'Edythe D', 'Initials': 'ED', 'LastName': 'London', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Shoptaw', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}]",Drug and alcohol review,['10.1111/dar.13019']
376,32170033,Randomised trial of azithromycin to eradicate Ureaplasma in preterm infants.,"OBJECTIVE
To test whether azithromycin eradicates Ureaplasma from the respiratory tract in preterm infants.
DESIGN
Prospective, phase IIb randomised, double-blind, placebo-controlled trial.
SETTING
Seven level III-IV US, academic, neonatal intensive care units (NICUs).
PATIENTS
Infants 24 0 -28 6 weeks' gestation (stratified 24 0 -26 6 ; 27 0 -28 6 weeks) randomly assigned within 4 days following birth from July 2013 to August 2016.
INTERVENTIONS
Intravenous azithromycin 20 mg/kg or an equal volume of D5W (placebo) every 24 hours for 3 days.
MAIN OUTCOME MEASURES
The primary efficacy outcome was Ureaplasma -free survival. Secondary outcomes were all-cause mortality, Ureaplasma clearance, physiological bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age, comorbidities of prematurity and duration of respiratory support.
RESULTS
One hundred and twenty-one randomised participants (azithromycin: n=60; placebo: n=61) were included in the intent-to-treat analysis (mean gestational age 26.2±1.4 weeks). Forty-four of 121 participants (36%) were Ureaplasma positive (azithromycin: n=19; placebo: n=25). Ureaplasma -free survival was 55/60 (92% (95% CI 82% to 97%)) for azithromycin compared with 37/61 (61% (95% CI 48% to 73%)) for placebo. Mortality was similar comparing the two treatment groups (5/60 (8%) vs 6/61 (10%)). Azithromycin effectively eradicated Ureaplasma in all azithromycin-assigned colonised infants, but 21/25 (84%) Ureaplasma -colonised participants receiving placebo were culture positive at one or more follow-up timepoints. Most of the neonatal mortality and morbidity was concentrated in 21 infants with lower respiratory tract Ureaplasma colonisation. In a subgroup analysis, physiological BPD-free survival was 5/10 (50%) (95% CI 19% to 81%) among azithromycin-assigned infants with lower respiratory tract Ureaplasma colonisation versus 2/11 (18%) (95% CI 2% to 52%) in placebo-treated infants.
CONCLUSION
A 3-day azithromycin regimen effectively eradicated respiratory tract Ureaplasma colonisation in this study.
TRIAL REGISTRATION NUMBER
NCT01778634.",2020,"Azithromycin effectively eradicated Ureaplasma in all azithromycin-assigned colonised infants, but 21/25 (84%) Ureaplasma -colonised participants receiving placebo were culture positive at one or more follow-up timepoints.","['27 0', '21 infants with lower respiratory tract Ureaplasma colonisation', 'n=60', 'preterm infants', 'Forty-four of 121 participants (36%) were', 'Seven level III-IV US, academic, neonatal intensive care units (NICUs', 'One hundred and twenty-one randomised participants', 'Infants 24 0']","['azithromycin', 'Azithromycin', 'placebo', 'Intravenous azithromycin 20 mg/kg or an equal volume of D5W (placebo']","['Ureaplasma -free survival', ""cause mortality, Ureaplasma clearance, physiological bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age, comorbidities of prematurity and duration of respiratory support"", 'neonatal mortality and morbidity', 'Mortality', 'physiological BPD-free survival']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0282335', 'cui_str': 'Respiratory Tract'}, {'cui': 'C0041944', 'cui_str': 'T-Mycoplasma'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0441927', 'cui_str': 'Level III (tumor staging)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C0041944', 'cui_str': 'T-Mycoplasma'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0728731', 'cui_str': 'Prematurity of fetus (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",21.0,0.779323,"Azithromycin effectively eradicated Ureaplasma in all azithromycin-assigned colonised infants, but 21/25 (84%) Ureaplasma -colonised participants receiving placebo were culture positive at one or more follow-up timepoints.","[{'ForeName': 'Rose Marie', 'Initials': 'RM', 'LastName': 'Viscardi', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland, USA rviscard@som.umaryland.edu.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Terrin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Laurence S', 'Initials': 'LS', 'LastName': 'Magder', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'Davis', 'Affiliation': 'Department of Pediatrics, University of Maryland Baltimore, Baltimore, Maryland, USA.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dulkerian', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Ken B', 'Initials': 'KB', 'LastName': 'Waites', 'Affiliation': 'Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'Department of Pediatrics, University of Virginia School of Medicine, Charlottesville, Virginia, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Donohue', 'Affiliation': 'Department of Pediatrics, Johns Hopkins Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Tuttle', 'Affiliation': 'Department of Pediatrics, Christiana Care Health System, Newark, Delaware, USA.'}, {'ForeName': 'Jorn-Hendrik', 'Initials': 'JH', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Hazem E', 'Initials': 'HE', 'LastName': 'Hassan', 'Affiliation': 'University of Maryland School of Pharmacy, Baltimore, Maryland, USA.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Eddington', 'Affiliation': 'University of Maryland School of Pharmacy, Baltimore, Maryland, USA.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-318122']
377,32232659,Continuous quadratus lumborum block and femoral nerve block for total hip arthroplasty: a randomized study.,"BACKGROUND
Continuous femoral nerve block (FNB) has been effectively used after total hip arthroplasty (THA). Recently the anterior approach to quadratus lumborum block (QLB) has been shown to produce postoperative pain relief after THA. Continuous QLB would benefit from a catheter insertion site that is farther away from the surgical site compared with continuous FNB. In this randomized controlled study, we compared analgesic effects of the two techniques in patients undergoing THA.
METHODS
Thirty patients undergoing THA were randomly allocated into two groups receiving continuous QLB and FNB. Under ultrasound guidance, QLB and FNB were conducted before general anesthesia using 0.25% levobupivacaine 30 ml and 0.5% levobupivacaine 15 ml, respectively, and a catheter was introduced. Postoperatively, all patients received continuous infusion of 0.125% levobupivacaine at 4 ml/h. Postoperative measurements included visual analog scale (VAS) pain scores at rest and on movement, postoperative analgesic demands, cutaneous sensory blockade and adverse events for 48 h.
RESULTS
Six patients were excluded and 24 patients (13 and 11 patients in QLB group and FNB, respectively) were analyzed. VAS scores on movement at 6 h [median (IQR): 67 (41-80) and 38 (22-41) in QLB and FNB groups, respectively, p = 0.008] and 24 h [60 (40-80) and 39 (28-64) in QLB and FNB groups, respectively, p = 0.018] were lower with FNB than with QLB. QLB did not produce consistent cutaneous sensory blockade.
CONCLUSIONS
Analgesic effects of continuous QLB were inferior to those of continuous FNB in patients undergoing THA under the current study condition.",2020,Continuous QLB would benefit from a catheter insertion site that is farther away from the surgical site compared with continuous FNB.,"['Thirty patients undergoing THA', 'total hip arthroplasty', 'patients undergoing THA', 'patients undergoing THA under the current study condition']","['continuous infusion of 0.125% levobupivacaine', 'Continuous quadratus lumborum block and femoral nerve block', 'Continuous femoral nerve block (FNB', 'QLB', 'continuous QLB and FNB', 'levobupivacaine 30\xa0ml and 0.5% levobupivacaine']","['visual analog scale (VAS) pain scores at rest and on movement, postoperative analgesic demands, cutaneous sensory blockade and adverse events for 48\xa0h', 'VAS scores on movement at 6\xa0h [median (IQR']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block (procedure)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",30.0,0.123723,Continuous QLB would benefit from a catheter insertion site that is farther away from the surgical site compared with continuous FNB.,"[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Aoyama', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Sakura', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan. ssakura@med.shimane-u.ac.jp.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Abe', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Tadenuma', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.'}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02769-9']
378,31863189,Prophylactic diphenhydramine attenuates postoperative catheter-related bladder discomfort in patients undergoing gynecologic laparoscopic surgery: a randomized double-blind clinical study.,"BACKGROUND
To evaluate the effectiveness of diphenhydramine, an antihistamine with anti-muscarinic properties, for prevention of postoperative catheter-related bladder discomfort (CRBD).
METHODS
Ninety-six ASA physical status I and II adult female patients (20-60 years) scheduled for elective gynecologic laparoscopic surgery were included. Patients were randomized into two groups of 48 patients each. All patients received a detailed preoperative explanation of the possible consequences of CRBD. The control group received normal saline 2 ml, whereas the diphenhydramine group received diphenhydramine 30 mg intravenously after induction of general anesthesia. Then, all patients were catheterized with a 14F Foley catheter and the balloon was inflated with 10 ml of distilled water. All patients who complained of CRBD in the postoperative room were appeased with nursing. Ketorolac 30 mg was used as the rescue drug on patients' request or when the patient was evaluated as having moderate or severe CRBD. Bladder discomfort and its severity were assessed at 1, 2 and 6 h postoperatively. The severity of CRBD was graded as none, mild, moderate and severe. Adverse effects of diphenhydramine such as sedation, dry mouth or GI upset were recorded.
RESULTS
The incidence of CRBD was lower in the diphenhydramine group compared with the control group at 2 h (34.8 vs. 58.7%, p = 0.02) and 6 h (23.9 vs. 56.5%, p < 0.01) postoperatively. Diphenhydramine treatment also reduced the severity of CRBD at 6 h postoperatively (p = 0.01). Moreover, the request for rescue for CRBD was lower in diphenhydramine group at 2 h (8.7 vs. 26.1%, p = 0.03). There were no significant differences in side effects, such as sedation, dry mouth or gastrointestinal upset between the two groups (p > 0.05).
CONCLUSION
Prophylactic diphenhydramine 30 mg at induction of general anesthesia reduced the incidence and severity of postoperative bladder discomfort without significant side effects in patients receiving gynecologic laparoscopic surgery.",2020,"There were no significant differences in side effects, such as sedation, dry mouth or gastrointestinal upset between the two groups (p > 0.05).
","['patients undergoing gynecologic laparoscopic surgery', 'Ninety-six ASA physical status', 'patients receiving gynecologic laparoscopic surgery', 'All patients who complained of CRBD in the postoperative room were appeased with nursing', 'I and II adult female patients (20-60\xa0years) scheduled for']","['Ketorolac', '14F Foley catheter and the balloon was inflated with 10\xa0ml of distilled water', 'Prophylactic diphenhydramine', 'normal saline 2\xa0ml', 'elective gynecologic laparoscopic surgery', 'diphenhydramine 30\xa0mg intravenously after induction of general anesthesia', 'diphenhydramine', 'Diphenhydramine']","['severity of CRBD', 'side effects, such as sedation, dry mouth or gastrointestinal upset', 'incidence of CRBD', 'Bladder discomfort and its severity', 'sedation, dry mouth or GI upset', 'request for rescue for CRBD', 'postoperative catheter-related bladder discomfort']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0179804'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C2697368', 'cui_str': 'Gastrointestinal irritation (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0686900', 'cui_str': 'Request for (contextual qualifier) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",96.0,0.160389,"There were no significant differences in side effects, such as sedation, dry mouth or gastrointestinal upset between the two groups (p > 0.05).
","[{'ForeName': 'Yu-Yu', 'Initials': 'YY', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Yan-Syun', 'Initials': 'YS', 'LastName': 'Zeng', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Jen-Yin', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Kuei-Fen', 'Initials': 'KF', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Chung-Hsi', 'Initials': 'CH', 'LastName': 'Hsing', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Wen-Ju', 'Initials': 'WJ', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Jhi-Joung', 'Initials': 'JJ', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Ping-Hsun', 'Initials': 'PH', 'LastName': 'Feng', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Chin-Chen', 'Initials': 'CC', 'LastName': 'Chu', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan. chinchen.chu@gmail.com.'}]",Journal of anesthesia,['10.1007/s00540-019-02724-3']
379,32208774,PGRMC1 in animal breast cancer tissue and blood is associated with increased tumor growth with norethisterone in contrast to progesterone and dydrogesterone: four-arm randomized placebo-controlled xenograft study.,"Progesterone receptor membrane component 1 (PGRMC1) is mediating strong breast cancer cell proliferation induced by certain synthetic progestogens which we have shown within already published in vitro studies. Aim was now to use an animal model, to compare tumor growth using progesterone and its isomer dydrogesterone with norethisterone, which elicited in our in vitro studies the strongest proliferating effect. For the first time, we wanted to investigate if growth can be correlated both with blood concentrations and tissue expression of PGRMC1 to identify if PGRMC1 could be a new tumor marker. Prospective, randomized, blinded, placebo-controlled four-arm study (45-50 days); PGRMC1-transfected or empty-vector T47D- and MCF7-xenotransplants were each treated with estradiol (E2) +placebo; E2 + progesterone; E2 + norethisterone; E2 + dydrogesterone; blood PGRMC1 assessed by a novel ELISA, tissue expression by immunohistochemistry. PGRMC1-transfected tumors further increased with E2 + norethisterone but not with E2-dydrogesterone or E2-progesterone. In both PGRMC1-xenograft groups (T47D, MCF7) with E2/norethisterone, the blood concentrations and tissue expression of PGRMC1 were higher than in all other 14 groups ( p < .05), with positive significant correlation between blood PGRMCI concentrations and tissue PGRMC1 expression. In the presence of PGRMC1, certain progestogens could increase the growth of breast tumor, which now also should be tested in clinical studies.",2020,Progesterone receptor membrane component 1 (PGRMC1) is mediating strong breast cancer cell proliferation induced by certain synthetic progestogens which we have shown within already published in vitro studies.,[],"['dydrogesterone with norethisterone', 'PGRMC1-transfected or empty-vector T47D- and MCF7-xenotransplants', 'PGRMC1', 'estradiol (E2) +placebo; E2\u2009+\u2009progesterone; E2\u2009+\u2009norethisterone; E2\u2009+\u2009dydrogesterone; blood PGRMC1', 'Progesterone receptor membrane component 1 (PGRMC1', 'placebo', 'dydrogesterone', 'norethisterone', 'progesterone']","['blood PGRMCI concentrations and tissue PGRMC1 expression', 'blood concentrations and tissue expression of PGRMC1']",[],"[{'cui': 'C0013340', 'cui_str': 'Dydrogesterone'}, {'cui': 'C0028356', 'cui_str': 'norethisterone'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0005768'}, {'cui': 'C0034833', 'cui_str': 'Receptors, Progestin'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0005768'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}]",,0.018652,Progesterone receptor membrane component 1 (PGRMC1) is mediating strong breast cancer cell proliferation induced by certain synthetic progestogens which we have shown within already published in vitro studies.,"[{'ForeName': 'Guiju', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': 'Department of Gynecological Endocrinology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiangyan', 'Initials': 'X', 'LastName': 'Ruan', 'Affiliation': 'Department of Gynecological Endocrinology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Muqing', 'Initials': 'M', 'LastName': 'Gu', 'Affiliation': 'Department of Gynecological Endocrinology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Gynecological Endocrinology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuejiao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecological Endocrinology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Alfred O', 'Initials': 'AO', 'LastName': 'Mueck', 'Affiliation': 'Department of Gynecological Endocrinology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2020.1742689']
380,32213797,Use of Topical Tranexamic Acid to Reduce Blood Loss in Single-Level Transforaminal Lumbar Interbody Fusion.,"STUDY DESIGN
Nonrandomized, prospective, and case-controlled study.
PURPOSE
To evaluate the efficacy and cost-effectiveness of topically applied tranexamic acid (TXA) during different phases of spine surgery.
OVERVIEW OF LITERATURE
Perioperative blood loss is the leading cause of postoperative anemia associated with prolonged stays in hospital and long recovery times. The direct and indirect costs involved pose a significant economic challenge in developing countries. There is no consensus for topical use of tranexamic acid in spine surgery.
METHODS
Patients requiring a single-level TLIF were divided into two groups. In the TXA group (n=75), the wound surface was soaked with TXA (1 g in 100 mL saline solution) for 3 minutes after exposure, after decompression, and before wound closure, and in the control group (n=175) using only saline. Intraoperative blood loss drain volume was recorded on each of the first 2 days immediately after surgery. An estimated cost analysis was made on the basis of the length of hospital stay and the blood transfusion.
RESULTS
IBL for the control group was 783.33±332.71 mL and for intervention group 410.57±189.72 mL (p<0.001). The operative time for control group was 3.24±0.38 hours and for intervention group 2.99±0.79 hours (p<0.695). Hemovac drainage on days 1 and 2 for control group was 167.10±53.83 mL and 99.33±37.5 mL, respectively, and for intervention group 107.03±44.37 mL and 53.38±21.99 mL, respectively (p<0.001). The length of stay was significantly shorter in the intervention group (4.8±1.1 days) compared to control group (7.0±2.3 days). The cost of treatment in the intervention group was US dollar (USD) 4,552.57±1,222.6 compared with that in the control group USD 6,529.9±1,505.04.
CONCLUSIONS
Topical TXA is a viable, cost-effective method of decreasing perioperative blood loss in major spine surgery with fewer overall complications than other methods. Further studies are required to find the ideal dosage and timing.",2020,The length of stay was significantly shorter in the intervention group (4.8±1.1 days) compared to control group (7.0±2.3 days).,"['Single-Level Transforaminal Lumbar Interbody Fusion', 'Methods\n\n\nPatients requiring a single-level TLIF']","['control group (n=175) using only saline', 'tranexamic acid', 'TXA', 'Topical TXA', 'tranexamic acid (TXA', 'Topical Tranexamic Acid']","['efficacy and cost-effectiveness', 'Hemovac drainage', 'length of stay', 'Intraoperative blood loss drain volume', 'operative time', 'Blood Loss']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",,0.0543874,The length of stay was significantly shorter in the intervention group (4.8±1.1 days) compared to control group (7.0±2.3 days).,"[{'ForeName': 'Abhinandan Reddy', 'Initials': 'AR', 'LastName': 'Mallepally', 'Affiliation': 'Department of Spine Services, Indian Spinal Injuries Centre, New Delhi, India.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Mahajan', 'Affiliation': 'Department of Spine Services, Indian Spinal Injuries Centre, New Delhi, India.'}, {'ForeName': 'Tarush', 'Initials': 'T', 'LastName': 'Rustagi', 'Affiliation': 'Department of Spine Services, Indian Spinal Injuries Centre, New Delhi, India.'}, {'ForeName': 'Shakti Amar', 'Initials': 'SA', 'LastName': 'Goel', 'Affiliation': 'Department of Spine Services, Indian Spinal Injuries Centre, New Delhi, India.'}, {'ForeName': 'Kalidutta', 'Initials': 'K', 'LastName': 'Das', 'Affiliation': 'Department of Spine Services, Indian Spinal Injuries Centre, New Delhi, India.'}, {'ForeName': 'Harvinder Singh', 'Initials': 'HS', 'LastName': 'Chhabra', 'Affiliation': 'Department of Spine Services, Indian Spinal Injuries Centre, New Delhi, India.'}]",Asian spine journal,['10.31616/asj.2019.0134']
381,31907645,"A randomized, double-blind, single-dose study to evaluate the biosimilarity of QL1101 with bevacizumab in healthy male subjects.","PURPOSE
This is the first study to compare the pharmacokinetics of QL1101, a proposed bevacizumab biosimilar, with Avastin ® sourced from Roche Diagnostics GmbH.
METHODS
In this double-blind, single-dose, parallel-group study, healthy male subjects were randomized 1:1 to receive QL1101 or Avastin ® 3 mg/kg intravenously. Pharmacokinetic assessments were conducted for 85 days, with additional safety and immunogenicity assessments until day 90. Primary study endpoints were area under the concentration-time curve (AUC) from time zero to infinity (AUC 0-∞ ), AUC from time zero to the last quantifiable concentration (AUC 0-last ), and maximum serum concentration (C max ). Pharmacokinetic equivalence was shown if the 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) of the C 0-max , AUC 0-last , and AUC 0-∞ were within the predefined bioequivalence margin of 80-125.00%.
RESULTS
A total of 82 subjects were randomized to the following groups: 42 to QL1101 and 40 to Avastin ® . The 90% CIs of the GMRs of AUC 0-∞ , AUC 0-last , and C max of QL1101 and Avastin® were (97.8%, 107.0%), (94.5%, 106.9%), and (94.1%, 107.3%), respectively, which were all within the bioequivalence margin. The incidence of adverse events was 90.5% and 95.0% in the QL1101 and Avastin® groups, respectively. Mean serum concentration-time profiles, secondary pharmacokinetic parameters, and safety and immunogenicity profiles were comparable across the two treatment groups.
CONCLUSIONS
The study demonstrated the pharmacokinetic equivalence of QL1101 to Avastin ® . QL1101 (3 mg/kg, iv) is safe and tolerable in healthy Chinese subjects. These data support the further clinical evaluation of QL1101 as a bevacizumab biosimilar.",2020,"Mean serum concentration-time profiles, secondary pharmacokinetic parameters, and safety and immunogenicity profiles were comparable across the two treatment groups.
","['healthy male subjects', 'healthy Chinese subjects', '82 subjects']","['QL1101 or Avastin ® 3\xa0mg/kg intravenously', 'QL1101 to Avastin ® ', 'QL1101 and 40 to Avastin ® ', 'QL1101 with bevacizumab', 'QL1101']","['Pharmacokinetic equivalence', 'Mean serum concentration-time profiles, secondary pharmacokinetic parameters, and safety and immunogenicity profiles', 'area under the concentration-time curve (AUC) from time zero to infinity (AUC 0-∞ ), AUC from time zero to the last quantifiable concentration (AUC 0-last ), and maximum serum concentration (C max ', 'incidence of adverse events', 'geometric mean ratios (GMRs) of the C 0-max , AUC 0-last , and AUC 0-∞', 'GMRs of AUC 0-∞ , AUC 0-last , and C max of QL1101 and Avastin®', 'safe and tolerable']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}]",82.0,0.110872,"Mean serum concentration-time profiles, secondary pharmacokinetic parameters, and safety and immunogenicity profiles were comparable across the two treatment groups.
","[{'ForeName': 'Ya-Nan', 'Initials': 'YN', 'LastName': 'Liu', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Wu', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xing-Fei', 'Initials': 'XF', 'LastName': 'Zhang', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Yang', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Cui-Cui', 'Initials': 'CC', 'LastName': 'Han', 'Affiliation': 'Qilu Pharmaceutical Co. Ltd, Jinan, Shangdong, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': 'Department of Pharmacy of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Pharmacy of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Qing-Nan', 'Initials': 'QN', 'LastName': 'He', 'Affiliation': 'Research Center for Drug Clinical Evaluation, Central South University, Changsha, Hunan, China. heqn2629@163.com.'}, {'ForeName': 'Guo-Ping', 'Initials': 'GP', 'LastName': 'Yang', 'Affiliation': 'Clinical Trails Center of the Third Xiangya Hospital, Central South University, Changsha, Hunan, China. ygp9880@126.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-04014-x']
382,31759333,Single and repeated ketamine infusions for reduction of suicidal ideation in treatment-resistant depression.,"Repeated administration of subanesthetic intravenous ketamine may prolong the rapid decrease in suicidal ideation (SI) elicited by single infusions. The purpose of this secondary analysis was to evaluate reduction in SI with a single ketamine infusion compared with an active control, and prolonged suppression of SI with repeated and maintenance infusions. Thirty-seven participants with treatment-resistant depression (TRD) and baseline SI first received a single ketamine infusion during a randomized, double-blind crossover with midazolam. Following relapse of depressive symptoms, participants received six open-label ketamine infusions administered thrice-weekly over 2 weeks. Antidepressant responders (≥50% decrease in Montgomery-Åsberg Depression Rating Scale [MADRS] scores) received four further open-label infusions administered once-weekly. Changes in SI were assessed with the suicide items on the MADRS (item 10, MADRS-SI) and the Quick Inventory of Depressive Symptomatology-Self Report (item 12, QIDS-SI). Linear mixed models revealed that compared with midazolam, a single ketamine infusion elicited larger reduction in SI (P = 0.01), with maximal effects measured at 7 days postinfusion (P < 0.001, Cohen's d = 0.83). Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94). QIDS-SI results were consistent with MADRS-SI. Overall, 69% of participants had a complete alleviation of SI following repeated infusions. In TRD, single and repeated ketamine infusions resulted in decreases in SI which were maintained with once-weekly maintenance infusions. This study adds to the growing body of research suggesting ketamine as a possible novel treatment strategy for SI in mood disorders.",2020,"Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94).",['Thirty-seven participants with treatment-resistant depression (TRD) and baseline SI first received a single'],"['midazolam', 'six open-label ketamine', 'ketamine', 'subanesthetic intravenous ketamine', 'ketamine infusion', 'ketamine infusions']","['Changes in SI', 'Quick Inventory of Depressive Symptomatology-Self Report', 'cumulative reductions in MADRS-SI scores', 'suicidal ideation (SI', 'SI', 'suicidal ideation', 'Montgomery-Åsberg Depression Rating Scale [MADRS] scores', 'complete alleviation of SI']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",37.0,0.234581,"Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94).","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Phillips', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada. Jennifer.Phillips@theroyal.ca.""}, {'ForeName': 'Sandhaya', 'Initials': 'S', 'LastName': 'Norris', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Talbot', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Hatchard', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Birmingham', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Olabisi', 'Initials': 'O', 'LastName': 'Owoeye', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Batten', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blier', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0570-x']
383,31232823,The Flower Petal Training System in Microsurgery: Validation of a Training Model Using a Randomized Controlled Trial.,"INTRODUCTION
Despite hundreds of training models for microsurgery being available in the literature, very few of them are scientifically validated. We chose to validate our low-fidelity training model on flower petals by comparing it head-to-head with a moderate fidelity training model, the anastomosis on chicken leg femoral artery.
MATERIALS AND METHODS
A total of 16 participants of different levels of expertise were randomized into 2 groups, 1 training on flower petals and 1 on chicken leg femoral arteries. The groups were evaluated on performing a rat femoral artery anastomosis using the validated Stanford Microsurgical Assessment (SMaRT) Scale. The Mann-Whitney U test was used to check for statistically significant differences between the groups. The flower petal sutures were also evaluated and Pearson correlation was used to check for associations between better petal anastomosis scores and better final SMaRT results.
RESULTS
After 6 weeks of flower petal training, microsurgical trainees had significantly better overall SMaRT scores than trainees using chicken leg training, better fine tissue feeling, and better scores in knot tying. The anastomosis times for the rat femoral arteries did not differ between the 2 groups. Good scores for flower petals strongly correlated with a better SMaRT score for the anastomosis. The number of rats used in training reduced after the implementation of this model in continuous training.
CONCLUSIONS
The flower petal technique, despite being a low-fidelity model, shows superiority in developing fine tissue feeling and improved knot tying in microsurgery beginners and intermediate level practitioners adding this training model to their program. Further research needs to establish if the improvements also apply to already seasoned microsurgeons and whether the petal score has predictive value for future clinical application.",2019,"After 6 weeks of flower petal training, microsurgical trainees had significantly better overall SMaRT scores than trainees using chicken leg training, better fine tissue feeling, and better scores in knot tying.",['16 participants of different levels of expertise'],"['rat femoral artery anastomosis using the validated Stanford Microsurgical Assessment (SMaRT) Scale', '1 training on flower petals and 1 on chicken leg femoral arteries']","['overall SMaRT scores', 'SMaRT score']","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0015801', 'cui_str': 'Femoral Artery'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3540799', 'cui_str': 'flowers'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus domesticus'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",16.0,0.0136135,"After 6 weeks of flower petal training, microsurgical trainees had significantly better overall SMaRT scores than trainees using chicken leg training, better fine tissue feeling, and better scores in knot tying.","[{'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Volovici', 'Affiliation': 'From the Department of Neurosurgery, Erasmus Stroke Center.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Dammers', 'Affiliation': 'From the Department of Neurosurgery, Erasmus Stroke Center.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Lawton', 'Affiliation': 'Department of Neurosurgery, The Barrow Neurological Institute, Phoenix, AZ.'}, {'ForeName': 'Clemens M F', 'Initials': 'CMF', 'LastName': 'Dirven', 'Affiliation': 'Department of Medical Decision Making, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Tijs', 'Initials': 'T', 'LastName': 'Ketelaar', 'Affiliation': 'Department of Plant Biology, Wageningen University, The Netherlands.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lanzino', 'Affiliation': 'Department of Neurosurgery, The Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Dragos G', 'Initials': 'DG', 'LastName': 'Zamfirescu', 'Affiliation': 'Zetta Plastic and Reconstructive Microsurgery Clinic, Bucharest, Romania.'}]",Annals of plastic surgery,['10.1097/SAP.0000000000001914']
384,31738372,Minocycline at 2 Different Dosages vs Placebo for Patients With Mild Alzheimer Disease: A Randomized Clinical Trial.,"Importance
There are no disease-modifying treatments for Alzheimer disease (AD), the most common cause of dementia. Minocycline is anti-inflammatory, protects against the toxic effects of β-amyloid in vitro and in animal models of AD, and is a credible repurposed treatment candidate.
Objective
To determine whether 24 months of minocycline treatment can modify cognitive and functional decline in patients with mild AD.
Design, Setting, and Participants
Participants were recruited into a double-blind randomized clinical trial from May 23, 2014, to April 14, 2016, with 24 months of treatment and follow-up. This multicenter study in England and Scotland involved 32 National Health Service memory clinics within secondary specialist services for people with dementia. From 886 screened patients, 554 patients with a diagnosis of mild AD (Standardised Mini-Mental State Examination [sMMSE] score ≥24) were randomized.
Interventions
Participants were randomly allocated 1:1:1 in a semifactorial design to receive minocycline (400 mg/d or 200 mg/d) or placebo for 24 months.
Main Outcomes and Measures
Primary outcome measures were decrease in sMMSE score and Bristol Activities of Daily Living Scale (BADLS), analyzed by intention-to-treat repeated-measures regression.
Results
Of 544 eligible participants (241 women and 303 men), the mean (SD) age was 74.3 (8.2) years, and the mean (SD) sMMSE score was 26.4 (1.9). Fewer participants completed 400-mg minocycline hydrochloride treatment (28.8% [53 of 184]) than 200-mg minocycline treatment (61.9% [112 of 181]) or placebo (63.7% [114 of 179]; P < .001), mainly because of gastrointestinal symptoms (42 in the 400-mg group, 15 in the 200-mg group, and 10 in the placebo group; P < .001), dermatologic adverse effects (10 in the 400-mg group, 5 in the 200-mg group, and 1 in the placebo group; P = .02), and dizziness (14 in the 400-mg group, 3 in the 200-mg group, and 1 in the placebo group; P = .01). Assessment rates were lower in the 400-mg group: 68.4% (119 of 174 expected) for sMMSE at 24 months compared with 81.8% (144 of 176) for the 200-mg group and 83.8% (140 of 167) for the placebo group. Decrease in sMMSE scores over 24 months in the combined minocycline group was similar to that in the placebo group (4.1 vs 4.3 points). The combined minocycline group had mean sMMSE scores 0.1 points higher than the placebo group (95% CI, -1.1 to 1.2; P = .90). The decrease in mean sMMSE scores was less in the 400-mg group than in the 200-mg group (3.3 vs 4.7 points; treatment effect = 1.2; 95% CI, -0.1 to 2.5; P = .08). Worsening of BADLS scores over 24 months was similar in all groups: 5.7 in the 400-mg group, 6.6 in the 200-mg group, and 6.2 in the placebo groups (treatment effect for minocycline vs placebo = -0.53; 95% CI, -2.4 to 1.3; P = .57; treatment effect for 400 mg vs 200 mg of minocycline = -0.31; 95% CI, -0.2 to 1.8; P = .77). Results were similar in different patient subgroups and in sensitivity analyses adjusting for missing data.
Conclusions and Relevance
Minocycline did not delay the progress of cognitive or functional impairment in people with mild AD during a 2-year period. This study also found that 400 mg of minocycline is poorly tolerated in this population.
Trial Registration
isrctn.org Identifier: ISRCTN16105064.",2020,"Minocycline is anti-inflammatory, protects against the toxic effects of β-amyloid in vitro and in animal models of AD, and is a credible repurposed treatment candidate.
","['544 eligible participants (241 women and 303 men', 'patients with mild AD', 'Patients With Mild Alzheimer Disease', '32 National Health Service memory clinics within secondary specialist services for people with dementia', '886 screened patients, 554 patients with a diagnosis of mild AD (Standardised Mini-Mental State Examination [sMMSE] score ≥24) were randomized']","['Placebo', 'minocycline hydrochloride', 'placebo', 'minocycline', 'Minocycline']","['Assessment rates', 'gastrointestinal symptoms', 'sMMSE scores', 'dermatologic adverse effects', 'cognitive and functional decline', 'Worsening of BADLS scores', 'mean sMMSE scores', 'sMMSE score and Bristol Activities of Daily Living Scale (BADLS), analyzed by intention-to-treat repeated-measures regression', 'mean (SD) sMMSE score', 'dizziness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026186', 'cui_str': 'Minocycline Hydrochloride'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205489', 'cui_str': 'Dermatologic (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0222045'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",554.0,0.722529,"Minocycline is anti-inflammatory, protects against the toxic effects of β-amyloid in vitro and in animal models of AD, and is a credible repurposed treatment candidate.
","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Howard', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Zubko', 'Affiliation': ""Old Age Psychiatry, King's College London, London, United Kingdom.""}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Bradley', 'Affiliation': 'Medical Research Council Population Health Research Unit, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Harper', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Pank', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Tabet', 'Affiliation': 'Department of Old Age Psychiatry, University of Sussex, Brighton, United Kingdom.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Livingston', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bentham', 'Affiliation': 'Birmingham and Solihull Mental Health National Health Service Foundation Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'McShane', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': 'Department of Old Age Psychiatry, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Ritchie', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Reeves', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lovestone', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Ballard', 'Affiliation': 'Medical School, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Noble', 'Affiliation': ""Department of Basic and Clinical Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Nilforooshan', 'Affiliation': 'Surrey and Borders Partnership National Health Service Foundation Trust, United Kingdom.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Wilcock', 'Affiliation': 'Department of Clinical Neurosciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gray', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2019.3762']
385,31537189,Intravenous Glibenclamide Reduces Lesional Water Uptake in Large Hemispheric Infarction.,"Background and Purpose- Prior studies have shown a linear relationship between computed tomography (CT)-derived radiodensity and water uptake, or brain edema, within stroke lesions. To test the hypothesis that intravenous glibenclamide (glyburide; BIIB093) reduces ischemic brain water uptake, we quantified the lesional net water uptake (NWU) on serial CT scans from patients enrolled in the phase 2 GAMES-RP Trial (Glyburide Advantage in Malignant Edema and Stroke). Methods- This was a post hoc exploratory analysis of the GAMES-RP study. Noncontrast CT scans performed between admission and day 7 (n=264) were analyzed in the GAMES-RP modified intention-to-treat sample. Quantitative change in CT radiodensity (ie, NWU) and midline shift (MLS) was measured. The gray and white matter NWU were also examined separately. Repeated-measures mixed-effects models were used to assess the effect of intravenous glibenclamide on MLS or NWU. Results- A median of 3 CT scans (interquartile range, 2-4) were performed per patient during the first 7 days after stroke. In a repeated-measures regression model, greater NWU was associated with increased MLS (β=0.23; 95% CI, 0.20-0.26; P <0.001). Treatment with intravenous glibenclamide was associated with reduced NWU (β=-2.80; 95% CI, -5.07 to -0.53; P =0.016) and reduced MLS (β=-1.50; 95% CI, -2.71 to -0.28; P =0.016). Treatment with intravenous glibenclamide reduced both gray and white matter water uptake. In mediation analysis, gray matter NWU (β=0.15; 95% CI, 0.11-0.20; P <0.001) contributed to a greater proportion of MLS mass effect, as compared with white matter NWU (β=0.08; 95% CI, 0.03-0.13; P =0.001). Conclusions- In this phase 2 post hoc analysis, intravenous glibenclamide reduced both water accumulation and mass effect after large hemispheric infarction. This study demonstrates NWU is a quantitative and modifiable biomarker of ischemic brain edema accumulation. Clinical Trial Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT01794182.",2019,"Treatment with intravenous glibenclamide was associated with reduced NWU (β=-2.80; 95% CI, -5.07 to -0.53; P =0.016) and reduced MLS (β=-1.50; 95% CI, -2.71 to -0.28; P =0.016).","['patients enrolled in the phase 2 GAMES-RP Trial (Glyburide Advantage in Malignant Edema and Stroke', 'Large Hemispheric Infarction']","[' and Purpose', 'Methods', 'glibenclamide (glyburide', 'glibenclamide', 'Conclusions', 'Intravenous Glibenclamide']","['Lesional Water Uptake', 'gray and white matter water uptake', 'lesional net water uptake (NWU', 'Quantitative change in CT radiodensity (ie, NWU) and midline shift (MLS', 'reduced MLS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0017628', 'cui_str': 'glibenclamide'}, {'cui': 'C0017105', 'cui_str': 'Gas Gangrene'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0017628', 'cui_str': 'glibenclamide'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1269776', 'cui_str': 'Gray'}, {'cui': 'C0682708'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",264.0,0.184044,"Treatment with intravenous glibenclamide was associated with reduced NWU (β=-2.80; 95% CI, -5.07 to -0.53; P =0.016) and reduced MLS (β=-1.50; 95% CI, -2.71 to -0.28; P =0.016).","[{'ForeName': 'Pongpat', 'Initials': 'P', 'LastName': 'Vorasayan', 'Affiliation': 'From the Division of Neurocritical Care and Center for Genomic Medicine, Massachusetts General Hospital, Boston (P.V., W.T.K.).'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Bevers', 'Affiliation': ""Divisions of Stroke, Cerebrovascular and Critical Care Neurology, Brigham and Women's Hospital, Boston, MA (M.B.B.).""}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Beslow', 'Affiliation': ""Departments of Neurology (L.A.B.), Division of Neurology, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania.""}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Sze', 'Affiliation': 'Division of Neuroradiology, Department of Radiology (G.S.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Molyneaux', 'Affiliation': 'Department of Neurology, University of Pittsburgh, PA (B.J.M.).'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Hinson', 'Affiliation': 'Department of Neurology, Oregon Health Sciences University, Portland (H.E.H.).'}, {'ForeName': 'J Marc', 'Initials': 'JM', 'LastName': 'Simard', 'Affiliation': 'Department of Neurosurgery, University of Maryland, Baltimore (J.M.S.).'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'von Kummer', 'Affiliation': 'Department of Neuroradiology, Universitätsklinikum Carl Gustav Carus, Dresden, Germany (R.v.K.).'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Sheth', 'Affiliation': 'Division of Neurocritical Care, Department of Neurology (K.N.S.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'W Taylor', 'Initials': 'WT', 'LastName': 'Kimberly', 'Affiliation': 'From the Division of Neurocritical Care and Center for Genomic Medicine, Massachusetts General Hospital, Boston (P.V., W.T.K.).'}]",Stroke,['10.1161/STROKEAHA.119.026036']
386,31126845,Subgroup analysis of older patients treated within the randomized phase 3 doxorubicin versus doxorubicin plus evofosfamide (SARC021) trial.,"BACKGROUND
More than half of patients with soft tissue sarcoma (STS) are aged ≥65 years (older), however contemporary data on the efficacy/safety of anthracycline chemotherapy in older patients with STS are lacking.
METHODS
SARC021 randomized patients to receive first-line doxorubicin or doxorubicin plus evofosfamide. The main aim of this study was to compare the outcome and safety of first-line anthracycline-based therapy in older patients compared with those <65 years. IRB approval was obtained at all participating sites and this research meets requirements for protection of human subjects.
RESULTS
Of 640 patients, 209 (33%) were older, with a median age 70 (range 65-89) years. The median overall survival (OS) was 16.7 months (95%CI: 13.2-20.0) in older patients compared to 20.1 months (95%CI: 16.9-23.2) in those aged <65 years (n = 431), HR 1.21 (95%CI: 0.99-1.48), p = .057. The median progression-free survival (PFS) in older patients was 6.3 months (95%CI: 5.8-7.2) compared to 6.0 (95%CI: 5.1-6.4) in those <65 years, HR 0.86 (95%CI: 0.70-1.05), p = .14. Older patients had significantly more hematological (141 [67%] versus 208 [48%], p < .0001), non-hematological (131 [63%] versus 215 [50%], p = .0097) and ≥ Grade 3 adverse events (178 [85%] versus 299 [69%], p = .0002), compared to younger patients. More older patients (30, 14%) stopped treatment due to adverse events compared to younger patients (22, 5%), p = .0001.
CONCLUSIONS
The efficacy of first-line anthracycline-based chemotherapy did not differ significantly between older and younger advanced sarcoma patients. Significantly more older patients stopped chemotherapy due to adverse events. These results provide a benchmark for daily clinical practice and future trials in older patients.",2020,"Older patients had significantly more hematological (141 [67%] versus 208 [48%], p < .0001), non-hematological (131 [63%] versus 215 [50%], p = .0097) and ≥ Grade 3 adverse events (178 [85%] versus 299 [69%], p = .0002), compared to younger patients.","['older patients with STS', 'patients with soft tissue sarcoma (STS) are aged ≥65\u202fyears (older', 'older and younger advanced sarcoma patients', 'older patients compared with those <65\u202fyears', 'SARC021 randomized patients to', 'Of 640 patients, 209 (33%) were older, with a median age 70 (range 65-89) years', 'older patients']","['first-line anthracycline-based therapy', 'anthracycline chemotherapy', 'receive first-line doxorubicin or doxorubicin plus evofosfamide', 'first-line anthracycline-based chemotherapy', 'doxorubicin versus doxorubicin plus evofosfamide']","['median overall survival (OS', 'non-hematological', 'adverse events', 'hematological', 'median progression-free survival (PFS']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma, Soft Tissue'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4080092'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",640.0,0.141073,"Older patients had significantly more hematological (141 [67%] versus 208 [48%], p < .0001), non-hematological (131 [63%] versus 215 [50%], p = .0097) and ≥ Grade 3 adverse events (178 [85%] versus 299 [69%], p = .0002), compared to younger patients.","[{'ForeName': 'Eugenie', 'Initials': 'E', 'LastName': 'Younger', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK; Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Ballman', 'Affiliation': 'Weill Cornell Medicine, NY, New York, USA.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Weill Cornell Medicine, NY, New York, USA.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Pápai', 'Affiliation': 'Allami Egeszsegugyi Kozpont (State Health Center), Budapest, Hungary.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Van Tine', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Attia', 'Affiliation': 'Mayo Clinic Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'UZ Leuven, Campus Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Reinke', 'Affiliation': 'SARC (Sarcoma Alliance for Research through Collaboration), Ann Arbor, MI, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Tap', 'Affiliation': 'Weill Cornell Medicine, NY, New York, USA; Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK; Institute of Cancer Research, London, UK. Electronic address: robin.jones4@nhs.net.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2019.05.008']
387,32191506,Comparing the Efficacy of a Compound Topical Anesthetic Versus Benzocaine: A Pilot Study.,"To compare the effectiveness of a combination of 10% lidocaine, 10% prilocaine, and 4% tetracaine versus 20% benzocaine for use as a topical anesthetic agent prior to dental injections. A double-blind randomized prospective clinical trial was conducted with 26 participants receiving a topical anesthetic of 20% benzocaine (control) and 26 participants receiving a compound topical anesthetic mixture of 10% lidocaine, 10% prilocaine, and 4% tetracaine (experimental) prior to a maxillary infiltration injection. The procedure was conducted by 1 operator with the Wand ® injection system. Pain was assessed directly with visual analog scale (VAS) scores and indirectly by measuring changes in heart rate at 4 different time points. Complications associated with the application of the topical anesthetics were also assessed. The experimental group had a significantly higher mean VAS score of 19.5 ± 19.7 mm versus 14.2 ± 14.6 mm for the control group ( p < .001). No significant differences in heart rate at any of the 4 measured time points compared with baseline were noted for either group. The experimental group had a significantly higher incidence of complications, including tissue sloughing, when compared with the control group ( p < .001). Participants in the control group reported significantly lower VAS scores than those in the experimental group. Both types of topical anesthetic showed similar impacts on alterations to heart rate. No benefits were seen with the use of 10% lidocaine, 10% prilocaine, and 4% tetracaine as a topical anesthetic prior to a maxillary infiltration of local anesthetic when compared with 20% benzocaine.",2020,"The experimental group had a significantly higher incidence of complications, including tissue sloughing, when compared with the control group ( p < .001).",['26 participants receiving a topical anesthetic of 20% benzocaine (control) and 26 participants receiving a'],"['lidocaine, 10% prilocaine, and 4% tetracaine versus 20% benzocaine', 'Compound Topical Anesthetic Versus Benzocaine', 'tetracaine', 'lidocaine', 'compound topical anesthetic mixture of 10% lidocaine, 10% prilocaine, and 4% tetracaine (experimental) prior to a maxillary infiltration injection', 'prilocaine']","['alterations to heart rate', 'VAS scores', 'Pain', 'mean VAS score', 'incidence of complications, including tissue sloughing', 'heart rate', 'visual analog scale (VAS) scores and indirectly by measuring changes in heart rate']","[{'cui': 'C0040464', 'cui_str': 'Topical anesthetic (substance)'}, {'cui': 'C0005059', 'cui_str': 'Benzocaine'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0039629', 'cui_str': 'Tetracaine'}, {'cui': 'C0005059', 'cui_str': 'Benzocaine'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic (substance)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",26.0,0.0846109,"The experimental group had a significantly higher incidence of complications, including tissue sloughing, when compared with the control group ( p < .001).","[{'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tom', 'Affiliation': 'Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bui', 'Affiliation': 'Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tanbonliong', 'Affiliation': 'Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, California.'}]",Anesthesia progress,['10.2344/anpr-66-03-05']
388,31418516,Predictors of response to insulin therapy in youth with poorly-controlled type 2 diabetes in the TODAY trial.,"OBJECTIVE
To understand the factors associated with glycemic control after starting insulin in youth with type 2 diabetes following glycemic failure (persistent HbA1c ≥8%) with metformin alone, metformin + rosiglitazone or metformin + lifestyle in the TODAY study.
METHODS
Change in HbA1c after add-on insulin therapy and the factors predictive of glycemic response were evaluated. At 1-year postinsulin initiation, 253 youth had a mean of 3.9 ± 1.0 visits since the time of insulin initiation. Participants were divided into three groups according to glycemic control: consistent decrease in HbA1c by ≥0.5%, change <0.5%, or consistent increase in HbA1c ≥0.5%, at 75% or more of the visits.
RESULTS
Within 1-year postinsulin initiation, 33.2% of participants had a consistent HbA1c decrease of ≥0.5%, 46.2% changed HbA1c <0.5%, and 20.6% had an increase ≥0.5%. At randomization into TODAY and at time of insulin initiation, the three glycemia groups were similar in age, sex, race-ethnicity, pubertal stage, BMI z-score, diabetes duration, and insulin secretion indices. Consistent HbA1c improvement was associated with higher insulin sensitivity (1/fasting insulin) at randomization and at time of failure, higher adiponectin at randomization, and was not associated with indices of β-cell function.
CONCLUSIONS
Response to add-on insulin was highly variable among youth in TODAY. Greater insulin sensitivity and higher adiponectin concentrations at randomization were associated with improved glycemic control after initiation of insulin. Due to limited information on adherence to insulin injections, the roles of adherence to the prescribed insulin regimen or psychosocial factors are unknown.",2019,"Consistent HbA1c improvement was associated with higher insulin sensitivity (1/fasting insulin) at randomization and at time of failure, higher adiponectin at randomization, and was not associated with indices of β-cell function.
","['youth with type 2 diabetes following glycemic failure (persistent HbA1c ≥8%) with', 'youth with poorly-controlled type 2 diabetes', '253 youth had a mean of 3.9\u2009±\u20091.0 visits since the time of insulin initiation']","['metformin alone, metformin\u2009+\u2009rosiglitazone or metformin\u2009+\u2009lifestyle', 'insulin therapy']","['insulin sensitivity', 'Greater insulin sensitivity and higher adiponectin concentrations']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",253.0,0.0741428,"Consistent HbA1c improvement was associated with higher insulin sensitivity (1/fasting insulin) at randomization and at time of failure, higher adiponectin at randomization, and was not associated with indices of β-cell function.
","[{'ForeName': 'Fida', 'Initials': 'F', 'LastName': 'Bacha', 'Affiliation': ""Children's Nutrition Research Center, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'El Ghormli', 'Affiliation': 'Biostatistics Center, George Washington University, Rockville, Maryland.'}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Arslanian', 'Affiliation': ""UPMC, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Zeitler', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lorraine E', 'Initials': 'LE', 'LastName': 'Levitt Katz', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Gandica', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Nancy T', 'Initials': 'NT', 'LastName': 'Chang', 'Affiliation': ""Children's Hospital of Los Angeles, Los Angeles, Louisiana.""}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Sprague', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Macleish', 'Affiliation': 'Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric diabetes,['10.1111/pedi.12906']
389,32188593,Hepatic de novo lipogenesis is suppressed and fat oxidation is increased by omega-3 fatty acids at the expense of glucose metabolism.,"OBJECTIVE
Increased hepatic de novo lipogenesis (DNL) is suggested to be an underlying cause in the development of nonalcoholic fatty liver disease and/or insulin resistance. It is suggested that omega-3 fatty acids (FA) lower hepatic DNL. We investigated the effects of omega-3 FA supplementation on hepatic DNL and FA oxidation using a combination of human in vivo and in vitro studies.
RESEARCH DESIGN AND METHODS
Thirty-eight healthy men were randomized to take either an omega-3 supplement (4 g/day eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) as ethyl esters) or placebo (4 g/day olive oil) and fasting measurements were made at baseline and 8 weeks. The metabolic effects of omega-3 FAs on intrahepatocellular triacylglycerol (IHTAG) content, hepatic DNL and FA oxidation were investigated using metabolic substrates labeled with stable-isotope tracers. In vitro studies, using a human liver cell-line was undertaken to gain insight into the intrahepatocellular effects of omega-3 FAs.
RESULTS
Fasting plasma TAG concentrations significantly decreased in the omega-3 group and remained unchanged in the placebo group. Eight weeks of omega-3 supplementation significantly decreased IHTAG, fasting and postprandial hepatic DNL while significantly increasing dietary FA oxidation and fasting and postprandial plasma glucose concentrations. In vitro studies supported the in vivo findings of omega-3 FAs (EPA+DHA) decreasing intracellular TAG through a shift in cellular metabolism away from FA esterification toward oxidation.
CONCLUSIONS
Omega-3 supplementation had a potent effect on decreasing hepatic DNL and increasing FA oxidation and plasma glucose concentrations. Attenuation of hepatic DNL may be considered advantageous; however, consideration is required as to what the potential excess of nonlipid substrates (eg, glucose) will have on intrahepatic and extrahepatic metabolic pathways.
TRIAL REGISTRATION NUMBER
NCT01936779.",2020,"Eight weeks of omega-3 supplementation significantly decreased IHTAG, fasting and postprandial hepatic DNL while significantly increasing dietary FA oxidation and fasting and postprandial plasma glucose concentrations.",['Thirty-eight healthy men'],"['Omega-3 supplementation', 'placebo', 'omega-3 FAs', 'omega-3 fatty acids', 'omega-3 FA supplementation', 'omega-3 supplementation', 'omega-3 supplement (4\u2009g/day eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) as ethyl esters) or placebo']","['Fasting plasma TAG concentrations', 'dietary FA oxidation and fasting and postprandial plasma glucose concentrations', 'IHTAG, fasting and postprandial hepatic DNL', 'hepatic DNL and increasing FA oxidation and plasma glucose concentrations', 'intrahepatocellular triacylglycerol (IHTAG) content, hepatic DNL and FA oxidation']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",38.0,0.0321803,"Eight weeks of omega-3 supplementation significantly decreased IHTAG, fasting and postprandial hepatic DNL while significantly increasing dietary FA oxidation and fasting and postprandial plasma glucose concentrations.","[{'ForeName': 'Charlotte J', 'Initials': 'CJ', 'LastName': 'Green', 'Affiliation': 'University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Pramfalk', 'Affiliation': 'University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Catriona A', 'Initials': 'CA', 'LastName': 'Charlton', 'Affiliation': 'University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Pippa J', 'Initials': 'PJ', 'LastName': 'Gunn', 'Affiliation': 'University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cornfield', 'Affiliation': 'University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pavlides', 'Affiliation': 'University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Karpe', 'Affiliation': 'University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hodson', 'Affiliation': 'University of Oxford, Oxford, Oxfordshire, UK leanne.hodson@ocdem.ox.ac.uk.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000871']
390,32207140,Cost-effectiveness of Medical Expulsive Therapy with ?-blockers for Large Distal Ureteral Stones in China.,"PURPOSE
To assess the cost-effectiveness of medical expulsive therapy (MET) versus observation for large distal ureteral stones in China and provide preliminary evidence for the determination of the course of MET by mathematical estimation.
MATERIALS AND METHODS
With linear success rate assumptions, a decision tree was constructed by TreeAge Pro 2011 software. The stones passage rates after observation or receiving 0.4 mg daily tamsulosin were estimated according to a large randomized clinical trial (RCT). The costs of ureteroscopy, drugs and examinations were estimated according to related price from pharmacies or hospitals, or the guidance price published by the government. MET was also compared with observation by the sensitivity analysis. The effectiveness of MET or observation was presented by quality-adjusted life-day. Mathematical estimation of stone expulsion time was made by using a decision-analytic Markov model under the assumption that the daily stone expulsion probability is constant.
RESULTS
In China, the MET was associated with a $295.1 cost advantage over observation. The cost of ureteroscopy has to decrease to $77.8 to reach cost equivalence between observation and MET. Observation is cost-effective only if ureteroscopy is very cheap or the difference of stone expulsion rates is insignificant. The estimated expulsion time was much longer than those reported in above mentioned RCT.
CONCLUSION
Due to the high cost of ureteroscopy, MET showed a cost advantage over observation in treating distal ureteral stones in China. The daily stone passage rate was inconstant. More studies are needed to find the appropriate duration of MET.",2020,The daily stone passage rate was inconstant.,['Large Distal Ureteral Stones in China'],"['tamsulosin', 'medical expulsive therapy (MET', 'Medical Expulsive Therapy']","['daily stone passage rate', 'stone expulsion rates', 'cost-effectiveness', 'stones passage rates', 'costs of ureteroscopy, drugs and examinations', 'estimated expulsion time']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.033047,The daily stone passage rate was inconstant.,"[{'ForeName': 'Yucong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ouyang', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Xifeng', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Zhangqun', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Jinchun', 'Initials': 'J', 'LastName': 'Xing', 'Affiliation': 'Department of Urology, The first affiliated hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}]",Urology journal,['10.22037/uj.v0i0.5433']
391,32401380,"Comparison of therapeutic efficacy of topical treatment with phenytoin and fluocinolone on cutaneous lichen planus: A randomized, double-blind trial.",,2020,,['cutaneous lichen planus'],['phenytoin and fluocinolone'],[],"[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0023646', 'cui_str': 'Lichen planus'}]","[{'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0060507', 'cui_str': 'fluocinolone'}]",[],,0.633,,"[{'ForeName': 'Mozhdeh', 'Initials': 'M', 'LastName': 'Sepaskhah', 'Affiliation': 'Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Hemmatian Boroujeni', 'Affiliation': 'Department of Dermatology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Javaheri', 'Affiliation': 'Department of Dermatology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Bagheri', 'Affiliation': 'Department of Biostatistics, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Dermatologic therapy,['10.1111/dth.13578']
392,32183815,Effectiveness of prescribing physical activity in parks to improve health and wellbeing - the park prescription randomized controlled trial.,"BACKGROUND
Programs promoting population health through physical activity (PA) and exposure to nature are popular, but few have been evaluated in randomized-controlled trials (RCTs).
OBJECTIVE
To investigate the effectiveness of a park prescription intervention (PPI) for improving total moderate-to-vigorous PA (MVPA), other PA related behaviors, quality of life (QoL) and cardio-metabolic health among adults.
METHODS
Healthy individuals aged 40 to 65 years were recruited through community health screenings and randomly assigned to 1) PPI: face-to-face Park Prescription + invitation to weekly exercise sessions in parks, or 2) control: standard PA materials. After the six-month intervention, participants completed accelerometer assessments, questionnaires on health behaviors and QoL, and health screenings. Independent sample t-tests were used to compare outcomes between groups, with secondary analysis adjusted for co-variates via multiple linear regression. A p-value <0.05 was considered statistically significant.
RESULTS
Eighty participants were allocated to each group. Participants with mean age of 51.1 (Standard Deviation: 6.3) years were predominantly female (79%) and of Chinese ethnicity (81%). Participation in the group exercise started at 48% and declined to 24% by week 26. At six-months, 145 (91%) participants attended health screenings for outcome measure collection, and 126 (79%) provided valid accelerometer data. Time spent in MVPA favored the PPI group but this difference was not statistically significant (4.4 (- 43.8, 52.7) minutes/week; when removing 2 extreme outliers 26.8 (- 9.7, 63.4) minutes/week). Time spent in parks (147.5 (2.1, 292.9) minutes/month), PA in parks (192.5 (59.5, 325.5) minutes/month), and recreational PA (48.7 (1.4, 96.0) minutes/week) were significantly greater in the PPI group. PPI also significantly improved psychological QoL (4.0 (0.0, 8.0).
DISCUSSION
PPI improved park use, PA in parks, recreational PA, and psychological QoL but not total MVPA. Future RCTs' are warranted to investigate PPI in different target populations and to provide further evidence for improvements in health outcomes.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02615392, 26 November 2015.",2020,"Time spent in MVPA favored the PPI group but this difference was not statistically significant (4.4 (- 43.8, 52.7) minutes/week; when removing 2 extreme outliers 26.8 (- 9.7, 63.4) minutes/week).","['6.3) years were predominantly female (79%) and of Chinese ethnicity (81', 'Healthy individuals aged 40 to 65\u2009years', 'Eighty participants', 'adults', 'Participants with mean age of 51.1 (Standard Deviation', '26 November 2015']","['park prescription intervention (PPI', 'prescribing physical activity', 'community health screenings and randomly assigned to 1) PPI: face-to-face Park Prescription + invitation to weekly exercise sessions in parks, or 2) control: standard PA materials']","['recreational PA', 'psychological QoL', 'health behaviors and QoL, and health screenings', 'Time spent in MVPA', 'Time spent in parks', 'total moderate-to-vigorous PA (MVPA), other PA related behaviors, quality of life (QoL) and cardio-metabolic health', 'park use, PA in parks, recreational PA, and psychological QoL']","[{'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]","[{'cui': 'C0562547', 'cui_str': 'Park (environment)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018687'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0562547', 'cui_str': 'Park (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",80.0,0.0981709,"Time spent in MVPA favored the PPI group but this difference was not statistically significant (4.4 (- 43.8, 52.7) minutes/week; when removing 2 extreme outliers 26.8 (- 9.7, 63.4) minutes/week).","[{'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Müller-Riemenschneider', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Tahir Foundation Building, Block MD1, 12 Science Drive 2, #09-01V, Singapore, 117549, Singapore. ephmf@nuhs.edu.sg.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Petrunoff', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Tahir Foundation Building, Block MD1, 12 Science Drive 2, #09-01V, Singapore, 117549, Singapore.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Tahir Foundation Building, Block MD1, 12 Science Drive 2, #09-01V, Singapore, 117549, Singapore.'}, {'ForeName': 'Alwyn', 'Initials': 'A', 'LastName': 'Ng', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Tahir Foundation Building, Block MD1, 12 Science Drive 2, #09-01V, Singapore, 117549, Singapore.'}, {'ForeName': 'Angelia', 'Initials': 'A', 'LastName': 'Sia', 'Affiliation': 'Centre for Urban Greenery & Ecology, National Parks Board Singapore, 1E Cluny Rd, Singapore Botanic Gardens, Singapore, 259569, Singapore.'}, {'ForeName': 'Anbumalar', 'Initials': 'A', 'LastName': 'Ramiah', 'Affiliation': 'Health for Life Centre, Alexandra Health Pte Ltd, 90 Yishun Central, Khoo Teck Puat Hospital, Singapore, 768828, Singapore.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Health for Life Centre, Alexandra Health Pte Ltd, 90 Yishun Central, Khoo Teck Puat Hospital, Singapore, 768828, Singapore.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Health for Life Centre, Alexandra Health Pte Ltd, 90 Yishun Central, Khoo Teck Puat Hospital, Singapore, 768828, Singapore.'}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Tahir Foundation Building, Block MD1, 12 Science Drive 2, #09-01V, Singapore, 117549, Singapore.'}, {'ForeName': 'Léonie', 'Initials': 'L', 'LastName': 'Uijtdewilligen', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Tahir Foundation Building, Block MD1, 12 Science Drive 2, #09-01V, Singapore, 117549, Singapore.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-00941-8']
393,31791039,Mechanistic link between right prefrontal cortical activity and anxious arousal revealed using transcranial magnetic stimulation in healthy subjects.,"Much of the mechanistic research on anxiety focuses on subcortical structures such as the amygdala; however, less is known about the distributed cortical circuit that also contributes to anxiety expression. One way to learn about this circuit is to probe candidate regions using transcranial magnetic stimulation (TMS). In this study, we tested the involvement of the dorsolateral prefrontal cortex (dlPFC), in anxiety expression using 10 Hz repetitive TMS (rTMS). In a within-subject, crossover experiment, the study measured anxiety in healthy subjects before and after a session of 10 Hz rTMS to the right dorsolateral prefrontal cortex (dlPFC). It used threat of predictable and unpredictable shock to induce anxiety and anxiety potentiated startle to assess anxiety. Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS. These results suggest a mechanistic link between right dlPFC activity and physiological anxiety expression. This result supports current models of prefrontal asymmetry in affect, and lays the groundwork for further exploration into the cortical mechanisms mediating anxiety, which may lead to novel anxiety treatments.",2020,"Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS.","['healthy subjects before and after a session of 10\u2009Hz rTMS to the right dorsolateral prefrontal cortex (dlPFC', 'healthy subjects']","['10\u2009Hz repetitive TMS (rTMS', 'transcranial magnetic stimulation', 'transcranial magnetic stimulation (TMS']",['anxiety-potentiated startle'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0546911', 'cui_str': 'To the right (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0106782,"Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS.","[{'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Balderston', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. nicholas.balderston@pennmedicine.upenn.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Beydler', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Zhi-De', 'Initials': 'ZD', 'LastName': 'Deng', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Radman', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Lago', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Luber', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grillon', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0583-5']
394,32209605,Adenoma detection by Endocuff-assisted versus standard colonoscopy in routine practice: a cluster-randomised crossover trial.,"OBJECTIVE
Endocuff Vision (ECV) is the second generation of a device designed to improve polyp detection. The aim of this study was to evaluate its impact on adenoma detection rate (ADR) in routine colonoscopy.
DESIGN
This cluster-randomised crossover trial compared Endocuff-assisted (ECV+) with standard (ECV-) colonoscopy. Two teams of 11 endoscopists each with prior ECV experience, balanced in terms of basal ADR, gender and case volume were compared. In randomised fashion, the teams started with ECV+ or ECV- and switched group after inclusion of half of the cases. The main outcome criterion was ADR difference between ECV+ and ECV-. Subgroup analysis was done for physicians with low and high ADR (< or ≥ 25%).
RESULTS
During two periods of 20 and 21 weeks, respectively, the 22 endoscopists included 2058 patients (1032 ECV- vs 1026 ECV+, both groups being comparable). Overall ADR for both groups taken together was higher with ECV (39.2%) than without (29.4%; p<0.001) irrespective of the sequence of use (ECV+ or ECV- first), but mostly in adenomas <1 cm. In the physician subgroup analysis, only high detectors showed a significant ADR increase (from 31% to 41%, p<0.001), while the increase in the low detectors was not significant (from 24% to 30%, p=0.11). ECV had a positive impact in all colonic locations, except for the rectum. No ECV- related complication was reported.
CONCLUSION
We observed a significant ADR difference of approximately 10% by the use of ECV. By subgroup analysis, this increase was significant only in physicians classified as high detectors.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov (NCT03344055).",2020,"Overall ADR for both groups taken together was higher with ECV (39.2%) than without (29.4%; p<0.001) irrespective of the sequence of use (ECV+ or ECV- first), but mostly in adenomas <1 cm.",[],"['Endocuff-assisted (ECV+) with standard (ECV-) colonoscopy', 'ECV', 'ECV+ or ECV', 'Endocuff-assisted versus standard colonoscopy']","['ADR difference between ECV+ and ECV', 'Overall ADR', 'low detectors', 'adenoma detection rate (ADR']",[],"[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}]",2058.0,0.204169,"Overall ADR for both groups taken together was higher with ECV (39.2%) than without (29.4%; p<0.001) irrespective of the sequence of use (ECV+ or ECV- first), but mostly in adenomas <1 cm.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Karsenti', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France karsenti@club-internet.fr.'}, {'ForeName': 'Gaelle', 'Initials': 'G', 'LastName': 'Tharsis', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Bastien', 'Initials': 'B', 'LastName': 'Perrot', 'Affiliation': 'Methodology Unit, UMR INSERM 1246 SPHERE, Université de Nantes, Université de Tours, Institut de Recherche en Santé (IRS2), Universite de Nantes, Nantes, Pays de la Loire, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cattan', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Tordjman', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Venezia', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Zrihen', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Gillot', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Gillet', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Hagege', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Samama', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Etienney', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lab', 'Affiliation': 'Private Pathology Institute, Rue de Wattignies, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Guigui', 'Affiliation': 'Private Pathology Institute, Rue de Wattignies, Paris, France.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Zago', 'Affiliation': 'Private Pathology Institute, Rue du Colisée, Paris, France.'}, {'ForeName': 'Bouchra', 'Initials': 'B', 'LastName': 'Benkessou', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Burtin', 'Affiliation': 'Digestive Oncology, Insitut Gustave Roussy, Villejuif, Île-de-France, France.'}, {'ForeName': 'Maryan', 'Initials': 'M', 'LastName': 'Cavicchi', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.'}]",Gut,['10.1136/gutjnl-2019-319565']
395,31391203,Baseline Characteristics of Randomized Participants in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).,"OBJECTIVE
GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) is a 36-center unmasked, parallel treatment group, randomized controlled trial evaluating four diabetes medications added to metformin in people with type 2 diabetes (T2DM). We report baseline characteristics and compare GRADE participants to a National Health and Nutrition Examination Survey (NHANES) cohort.
RESEARCH DESIGN AND METHODS
Participants were age ≥30 years at the time of diagnosis, with duration of T2DM <10 years, HbA 1c 6.8-8.5% (51-69 mmol/mol), prescribed metformin monotherapy, and randomized to glimepiride, sitagliptin, liraglutide, or insulin glargine.
RESULTS
At baseline, GRADE's 5,047 randomized participants were 57.2 ± 10.0 years of age, 63.6% male, with racial/ethnic breakdown of 65.7% white, 19.8% African American, 3.6% Asian, 2.7% Native American, 7.6% other or unknown, and 18.4% Hispanic/Latino. Duration of diabetes was 4.2 ± 2.8 years, with mean HbA 1c of 7.5 ± 0.5% (58 ± 5.3 mmol/mol), BMI of 34.3 ± 6.8 kg/m 2 , and metformin dose of 1,944 ± 204 mg/day. Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke. Applying GRADE inclusion criteria to NHANES indicates enrollment of a representative cohort with T2DM on metformin monotherapy (NHANES cohort average age, 57.9 years; mean HbA 1c , 7.4% [57 mmol/mol]; BMI, 33.2 kg/m 2 ; duration, 4.2 ± 2.5 years; and 7.2% with a history of cardiovascular disease).
CONCLUSIONS
The GRADE cohort represents patients with T2DM treated with metformin requiring a second diabetes medication. GRADE will inform decisions about the clinical effectiveness of the addition of four classes of diabetes medications to metformin.",2019,"Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke.","['Participants were age ≥30 years at the time of diagnosis, with duration of T2DM <10 years, HbA 1c 6.8-8.5% (51-69 mmol/mol), prescribed', 'requiring a second diabetes medication', '5,047 randomized participants were 57.2 ± 10.0 years of age, 63.6% male, with racial/ethnic breakdown of 65.7% white, 19.8% African American, 3.6% Asian, 2.7% Native American, 7.6% other or unknown, and 18.4% Hispanic/Latino', 'people with type 2 diabetes (T2DM', 'GRADE participants to a National Health and Nutrition Examination Survey (NHANES) cohort', 'Diabetes', 'NHANES cohort average age, 57.9 years; mean HbA 1c , 7.4% [57 mmol/mol]; BMI, 33.2 kg/m 2 ; duration, 4.2 ± 2.5 years; and 7.2% with a history of cardiovascular disease']","['metformin monotherapy', 'metformin', 'glimepiride, sitagliptin, liraglutide, or insulin glargine']","['history of hypertension', 'history of heart attack or stroke']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0449238', 'cui_str': 'Duration (attribute)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0376344', 'cui_str': 'National Health and Nutrition Examination Survey'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0455539', 'cui_str': 'H/O: cardiovascular disease'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",69.0,0.0711735,"Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke.","[{'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': 'Diabetes Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA grademail@bsc.gwu.edu.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Krause-Steinrauf', 'Affiliation': 'The George Washington University Biostatistics Center, Rockville, MD.'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Hermes J', 'Initials': 'HJ', 'LastName': 'Florez', 'Affiliation': 'University of Miami, Geriatric Research, Education, and Clinical Center-Miami Veterans Affairs Healthcare System, Miami, FL.'}, {'ForeName': 'Sophia H', 'Initials': 'SH', 'LastName': 'Hox', 'Affiliation': 'Pacific Health Research & Education Institute, Honolulu, HI.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kuhn', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, MD.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Sood', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Underkofler', 'Affiliation': 'University of Colorado, Denver, Denver, CO.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0901']
396,32403118,Proof of mechanism and target engagement of glutamatergic drugs for the treatment of schizophrenia: RCTs of pomaglumetad and TS-134 on ketamine-induced psychotic symptoms and pharmacoBOLD in healthy volunteers.,"Glutamate neurotransmission is a prioritized target for antipsychotic drug development. Two metabotropic glutamate receptor 2/3 (mGluR2/3) agonists (pomaglumetad [POMA] and TS-134) were assessed in two Phase Ib proof of mechanism studies of comparable designs and using identical clinical assessments and pharmacoBOLD methodology. POMA was examined in a randomized controlled trial under double-blind conditions for 10-days at doses of 80 or 320 mg/d POMA versus placebo (1:1:1 ratio). The TS-134 trial was a randomized, single-blind, 6-day study of 20 or 60 mg/d TS-134 versus placebo (5:5:2 ratio). Primary outcomes were ketamine-induced changes in pharmacoBOLD in the dorsal anterior cingulate cortex (dACC) and symptoms reflected on the Brief Psychiatric Rating Scale (BPRS). Both trials were conducted contemporaneously. 95 healthy volunteers were randomized to POMA and 63 to TS-134. High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d = -0.41; p = 0.04, d = -0.44, respectively), but neither POMA dose significantly suppressed ketamine-induced dACC pharmacoBOLD. In contrast, low-dose TS-134 led to moderate to large within and between group reductions in both BPRS positive symptoms (p = 0.02, d = -0.36; p = 0.008, d = -0.82, respectively) and dACC pharmacoBOLD (p = 0.004, d = -0.56; p = 0.079, d = -0.50, respectively) using pooled across-study placebo data. High-dose POMA exerted significant effects on clinical symptoms, but not on target engagement, suggesting a higher dose may yet be needed, while the low dose of TS-134 showed evidence of symptom reduction and target engagement. These results support further investigation of mGluR2/3 and other glutamate-targeted treatments for schizophrenia.",2020,"High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d ","['healthy volunteers', '95 healthy volunteers']","['POMA versus placebo', 'TS-134 versus placebo', 'Two metabotropic glutamate receptor 2/3 (mGluR2/3) agonists (pomaglumetad [POMA] and TS-134', 'ketamine']","['BPRS positive symptoms', 'dACC pharmacoBOLD', 'BPRS total symptoms', 'clinical symptoms', 'ketamine-induced changes in pharmacoBOLD in the dorsal anterior cingulate cortex (dACC) and symptoms reflected on the Brief Psychiatric Rating Scale (BPRS']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1098057', 'cui_str': 'poly(n-octyl methacrylate)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0206529', 'cui_str': 'Metabotropic Glutamate Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}]",95.0,0.504117,"High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d ","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Kantrowitz', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Grinband', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Goff', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY, USA.'}, {'ForeName': 'Adrienne C', 'Initials': 'AC', 'LastName': 'Lahti', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Marder', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Ragy R', 'Initials': 'RR', 'LastName': 'Girgis', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sobeih', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY, USA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Green', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Yvonne S', 'Initials': 'YS', 'LastName': 'Yang', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Junghee', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Horga', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'William Z', 'Initials': 'WZ', 'LastName': 'Potter', 'Affiliation': 'National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Javitt', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'Columbia University, New York, NY, USA. Jeffrey.Lieberman@nyspi.columbia.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0706-z']
397,32404378,Effect of high-salt diet on blood pressure and body fluid composition in patients with type 1 diabetes: randomized controlled intervention trial.,"INTRODUCTION
Patients with type 1 diabetes are susceptible to hypertension, possibly resulting from increased salt sensitivity and accompanied changes in body fluid composition. We examined the effect of a high-salt diet (HSD) in type 1 diabetes on hemodynamics, including blood pressure (BP) and body fluid composition.
RESEARCH DESIGN AND METHODS
We studied eight male patients with type 1 diabetes and 12 matched healthy controls with normal BP, body mass index, and renal function. All subjects adhered to a low-salt diet and HSD for eight days in randomized order. On day 8 of each diet, extracellular fluid volume (ECFV) and plasma volume were calculated with the use of iohexol and 125 I-albumin distribution. Hemodynamic measurements included BP, cardiac output (CO), and systemic vascular resistance.
RESULTS
After HSD, patients with type 1 diabetes showed a BP increase (mean arterial pressure: 85 (5) mm Hg vs 80 (3) mm Hg; p<0.05), while BP in controls did not rise (78 (5) mm Hg vs 78 (5) mm Hg). Plasma volume increased after HSD in patients with type 1 diabetes (p<0.05) and not in controls (p=0.23). There was no significant difference in ECFV between diets, while HSD significantly increased CO, heart rate (HR) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) in type 1 diabetes but not in controls. There were no significant differences in systemic vascular resistance, although there was a trend towards an HSD-induced decrease in controls (p=0.09).
CONCLUSIONS
In the present study, patients with type 1 diabetes show a salt-sensitive BP rise to HSD, which is accompanied by significant increases in plasma volume, CO, HR, and NT-proBNP. Underlying mechanisms for these responses need further research in order to unravel the increased susceptibility to hypertension and cardiovascular disease in diabetes.
TRIAL REGISTRATION NUMBERS
NTR4095 and NTR4788.",2020,"There were no significant differences in systemic vascular resistance, although there was a trend towards an HSD-induced decrease in controls (p=0.09).
","['eight male patients with type 1 diabetes and 12 matched healthy controls with normal BP, body mass index, and renal function', 'patients with type 1 diabetes']","['high-salt diet', 'high-salt diet (HSD', 'iohexol']","['BP, cardiac output (CO), and systemic vascular resistance', 'BP increase (mean arterial pressure', 'plasma volume, CO, HR, and NT-proBNP', 'blood pressure and body fluid composition', 'systemic vascular resistance', 'ECFV', 'Plasma volume', 'blood pressure (BP) and body fluid composition', 'CO, heart rate (HR) and N-terminal pro-B-type natriuretic peptide (NT-proBNP', 'extracellular fluid volume (ECFV) and plasma volume']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0497247', 'cui_str': 'Elevated blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015349', 'cui_str': 'Extracellular fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",8.0,0.034718,"There were no significant differences in systemic vascular resistance, although there was a trend towards an HSD-induced decrease in controls (p=0.09).
","[{'ForeName': 'Eliane F E', 'Initials': 'EFE', 'LastName': 'Wenstedt', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'Nienke M G', 'Initials': 'NMG', 'LastName': 'Rorije', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'Rik H G', 'Initials': 'RHG', 'LastName': 'Olde Engberink', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'van der Molen', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Chahid', 'Affiliation': 'Department of Pharmacy, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'A H Jan', 'Initials': 'AHJ', 'LastName': 'Danser', 'Affiliation': 'Department of Internal Medicine, Erasmus MC, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Bert-Jan H', 'Initials': 'BH', 'LastName': 'van den Born', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'Liffert', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands l.vogt@amsterdamumc.nl.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-001039']
398,32199523,"Microbiota Stability and Gastrointestinal Tolerance in Response to a High-Protein Diet with and without a Prebiotic, Probiotic, and Synbiotic: A Randomized, Double-Blind, Placebo-Controlled Trial in Older Women.","BACKGROUND
Higher protein intakes may help reduce sarcopenia and facilitate recovery from illness and injury in older adults. However, high-protein diets (HPDs) including animal-sourced foods may negatively perturb the microbiota, and provision of probiotics and prebiotics may mitigate these effects.
OBJECTIVE
The aim of this study was to examine the effects of HPD, with and without a probiotic and/or prebiotic, on gut microbiota and wellness in older women.
DESIGN
We conducted an 18-week, double-blind, placebo-controlled, crossover study.
PARTICIPANTS/SETTING
Participants were healthy, older women (mean age±standard deviation=73.7±5.6 years; n=26) recruited from Florida.
INTERVENTION
Participants received a weight-maintenance HPD for 2-week periods and the following, in random order: HPD alone (1.5 to 2.2 g/kg/day protein); HPD plus multistrain probiotic formulation (1.54×10 9 Bifidobacterium bifidum HA-132, 4.62×10 9 Bifidobacterium breve HA-129, 4.62×10 9 Bifidobacterium longum HA-135, 4.62×10 9 Lactobacillus acidophilus HA-122, and 4.62×10 9 Lactobacillus plantarum HA-119), HPD plus prebiotic (5.6 g inulin), and HPD plus synbiotic (probiotic plus inulin), separated by 2-week washouts. Stools were collected per period for quantitative polymerase chain reaction (strain recovery) and 16S ribosomal RNA gene amplicon sequencing analyses (microbiota profile). Measures of gastrointestinal and general wellness were assessed.
MAIN OUTCOME MEASURES
Microbiota composition and probiotic strain recovery were measured.
STATISTICAL ANALYSES
Microbiota composition was analyzed by Wilcoxon signed-rank test and t test. Secondary outcomes were analyzing using generalized linear mixed models.
RESULTS
The microbiota profile demonstrated relative stability with the HPD; representation of Lactobacillus, Lactococcus, and Streptococcus were enhanced, whereas butyrate producers, Roseburia and Anaerostipes, were suppressed. Lactococcus was suppressed with synbiotic vs other HPD periods. Recovery was confirmed for all probiotic strains. Indicators of wellness were unchanged, with the exception of a minimal increase in gastrointestinal distress with inulin. Fat-free mass increased from baseline to study end.
CONCLUSIONS
An HPD adhering to the recommended acceptable macronutrient distribution ranges maintains wellness in healthy older women and exerts minor perturbations to the microbiome profile, a group that may benefit from a higher protein intake. ClinicalTrials.gov ID: NCT #02445560.",2020,"The microbiota profile demonstrated relative stability with the HPD; representation of Lactobacillus, Lactococcus, and Streptococcus were enhanced, whereas butyrate producers, Roseburia and Anaerostipes, were suppressed.","['older women', 'healthy older women', 'older adults', 'Participants were healthy, older women (mean age±standard deviation=73.7±5.6 years; n=26) recruited from Florida', 'Older Women']","['HPD alone (1.5 to 2.2 g/kg/day protein); HPD plus multistrain probiotic formulation (1.54×10 9 Bifidobacterium bifidum HA-132, 4.62×10 9 Bifidobacterium breve HA-129, 4.62×10 9 Bifidobacterium longum HA-135, 4.62×10 9 Lactobacillus acidophilus HA-122, and 4.62×10 9 Lactobacillus plantarum HA-119), HPD plus prebiotic (5.6 g inulin), and HPD plus synbiotic (probiotic plus inulin', 'placebo', 'weight-maintenance HPD', 'High-Protein Diet with and without a Prebiotic, Probiotic, and Synbiotic', 'HPD, with and without a probiotic and/or prebiotic', 'Placebo']","['Fat-free mass', 'gastrointestinal distress', 'Microbiota Stability and Gastrointestinal Tolerance', 'gastrointestinal and general wellness', 'Microbiota composition and probiotic strain recovery']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016253', 'cui_str': 'Florida'}]","[{'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C1532536', 'cui_str': 'g/kg/day'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0425403', 'cui_str': 'Diet, High-Protein'}]","[{'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]",,0.199913,"The microbiota profile demonstrated relative stability with the HPD; representation of Lactobacillus, Lactococcus, and Streptococcus were enhanced, whereas butyrate producers, Roseburia and Anaerostipes, were suppressed.","[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Ford', 'Affiliation': ''}, {'ForeName': 'Varuni', 'Initials': 'V', 'LastName': 'Nagulesapillai', 'Affiliation': ''}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Piano', 'Affiliation': ''}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Auger', 'Affiliation': ''}, {'ForeName': 'Stephanie-Anne', 'Initials': 'SA', 'LastName': 'Girard', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Christman', 'Affiliation': ''}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Tompkins', 'Affiliation': ''}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Dahl', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.12.009']
399,32199540,Impact of recovery support navigators on continuity of care after detoxification.,"Although evidence points to the benefits of continuity of care after detoxification (detox), especially when continuity of care occurs within a short time after discharge from a detox episode, the rate at which clients engage in continued treatment after detox remains low. The goal of the study was to develop and deploy a specially trained workforce, called recovery support navigators (RSNs), to increase the likelihood of clients continuing onto treatment after detox. Continuity of care is defined as receiving any substance use disorder (SUD) treatment service within 14 days of discharge from the index detox. We examined whether clients in the RSN Intervention group were more likely to meet the continuity of care after detox criteria than clients in the treatment-as-usual (TAU) group. A quasi-experimental intervention versus comparison group study was conducted. Data were from the Massachusetts Behavioral Health Partnership (MBHP), a Beacon Health Options company that manages behavioral health benefits for a subset of Medicaid beneficiaries in the state. Inclusion in the analytic sample (N = 4,236) required that the client's index admission to detox was between 3/29/13 and 3/31/15. RSN Intervention versus TAU status was assigned based on provider organization where the index detox occurred. Analyses were conducted on an intent-to-treat basis. Overall, the continuity of care rate across all study groups was 42%. The rate by study group was 38% for the TAU and 45% for the RSN group. Clients who were in the RSN group were significantly more likely to have continuity of care after discharge from detox than those in the TAU (OR = 1.233, p < .05, 95% CI = 1.044, 1.455). Clients who entered detox at a site that provided specialized training to RSN, which included motivational interviewing and educational sessions related to treatment issues, and allowing them to bill with a flexible daily case rate instead of the usual fee-for-service billing, were more likely to have continuity of care after discharge from detox compared to clients in the TAU group.",2020,"Clients who entered detox at a site that provided specialized training to RSN, which included motivational interviewing and educational sessions related to treatment issues, and allowing them to bill with a flexible daily case rate instead of the usual fee-for-service billing, were more likely to have continuity of care after discharge from detox compared to clients in the TAU group.","['Clients who entered detox at a site that provided specialized training to RSN, which included']","['motivational interviewing and educational sessions', 'RSN Intervention', 'recovery support navigators']","['continuity of care rate', 'continuity of care after discharge from detox']","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0009853', 'cui_str': 'Continuity of Care'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",,0.035958,"Clients who entered detox at a site that provided specialized training to RSN, which included motivational interviewing and educational sessions related to treatment issues, and allowing them to bill with a flexible daily case rate instead of the usual fee-for-service billing, were more likely to have continuity of care after discharge from detox compared to clients in the TAU group.","[{'ForeName': 'Margaret T', 'Initials': 'MT', 'LastName': 'Lee', 'Affiliation': 'Institute for Behavioral Health, Schneider Institutes for Health Policy, Heller School for Social Policy and Management, Brandeis University, 415 South Street, MS 035, Waltham, MA 02453, USA. Electronic address: mlee@brandeis.edu.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Torres', 'Affiliation': 'Institute for Behavioral Health, Schneider Institutes for Health Policy, Heller School for Social Policy and Management, Brandeis University, 415 South Street, MS 035, Waltham, MA 02453, USA; Smith College School for Social Work, 213 Lilly Hall, Northampton, MA 01063, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Brolin', 'Affiliation': 'Institute for Behavioral Health, Schneider Institutes for Health Policy, Heller School for Social Policy and Management, Brandeis University, 415 South Street, MS 035, Waltham, MA 02453, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Merrick', 'Affiliation': 'Institute for Behavioral Health, Schneider Institutes for Health Policy, Heller School for Social Policy and Management, Brandeis University, 415 South Street, MS 035, Waltham, MA 02453, USA.'}, {'ForeName': 'Grant A', 'Initials': 'GA', 'LastName': 'Ritter', 'Affiliation': 'Institute for Behavioral Health, Schneider Institutes for Health Policy, Heller School for Social Policy and Management, Brandeis University, 415 South Street, MS 035, Waltham, MA 02453, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Panas', 'Affiliation': 'Institute for Behavioral Health, Schneider Institutes for Health Policy, Heller School for Social Policy and Management, Brandeis University, 415 South Street, MS 035, Waltham, MA 02453, USA.'}, {'ForeName': 'Constance M', 'Initials': 'CM', 'LastName': 'Horgan', 'Affiliation': 'Institute for Behavioral Health, Schneider Institutes for Health Policy, Heller School for Social Policy and Management, Brandeis University, 415 South Street, MS 035, Waltham, MA 02453, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lane', 'Affiliation': 'Institute for Behavioral Health, Schneider Institutes for Health Policy, Heller School for Social Policy and Management, Brandeis University, 415 South Street, MS 035, Waltham, MA 02453, USA; Massachusetts Behavioral Health Partnership, a Beacon Health Options company, 1000 Washington Street, Suite 310, Boston, MA 02118, USA.'}, {'ForeName': 'Jonna C', 'Initials': 'JC', 'LastName': 'Hopwood', 'Affiliation': 'Massachusetts Behavioral Health Partnership, a Beacon Health Options company, 1000 Washington Street, Suite 310, Boston, MA 02118, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'De Marco', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401, Boston, MA 02215, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gewirtz', 'Affiliation': 'Massachusetts Behavioral Health Partnership, a Beacon Health Options company, 1000 Washington Street, Suite 310, Boston, MA 02118, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.01.019']
400,32199548,Psychosocial intervention utilization and substance abuse treatment outcomes in a multisite sample of individuals who use opioids.,"BACKGROUND
There are several relatively safe and effective FDA-approved medications for Opioid Use Disorder (OUD). Despite the existence of these medications, the rate of returning to opioid use after treatment is relatively high, underscoring the need for continued enhancement of treatments. Adjunctive psychosocial interventions paired with medication have been shown to improve OUD treatment outcomes. However, studies have yet to conclusively examine the distinct effects of the most widely utilized psychosocial treatment modalities. The current study will investigate the relationship between individual counseling, group therapy, and 12-Step participation and illicit opioid abstinence at the end of treatment, 1 and 3 months after treatment.
METHOD
A secondary analysis was conducted with data from a sample of 570 individuals diagnosed with OUD who were recruited from eight substance abuse treatment centers in the United States. Participants were enrolled in a two-group randomized, controlled trial testing buprenorphine-naloxone versus extended-release naltrexone for OUD. A two-level hierarchical linear growth model was used to examine the effects of individual counseling, group therapy, and 12-Step participation on illicit opioid abstinence (urinanalyses) 1- and 3-months post-treatment.
RESULTS
Hours of individual counseling and 12-Step participation significantly predicted abstinence at follow-up (p < .001, b = -0.59, 95% CI [0.42, 0.74]; p < .01, b = -0.05, 95% CI [0.92, 0.98]). There was a significant interaction between individual counseling and 12-Step participation (p < .01, b = -0.06, 95% CI [1.02, 1.10]). Additionally, participant age and employment status were significant predictors of illicit opioid abstinence (p < .01, b = -0.02, 95% CI [0.97, 0.99]; p < .01, b = -0.38, 95% CI [0.52, 0.90]). Hours of group therapy was not found to significantly predict illicit opioid abstinence.
CONCLUSIONS
Findings suggest that greater levels of individual therapy and 12-Step participation may be beneficial for individuals receiving medication treatment for OUD.",2020,There was a significant interaction between individual counseling and 12-Step participation (p < .01,"['individuals receiving medication treatment for OUD', '570 individuals diagnosed with OUD who were recruited from eight substance abuse treatment centers in the United States', 'multisite sample of individuals who use opioids']",['buprenorphine-naloxone versus extended-release naltrexone for OUD'],"['illicit opioid abstinence (urinanalyses', 'illicit opioid abstinence']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3469597', 'cui_str': 'Medication treatment'}, {'cui': 'C0079256', 'cui_str': 'Substance Abuse Treatment Centers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]","[{'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",570.0,0.0375649,There was a significant interaction between individual counseling and 12-Step participation (p < .01,"[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Harvey', 'Affiliation': 'Department of Psychological, Health, & Learning Sciences, University of Houston, 3657 Cullen Blvd, Houston, TX 77204, United States.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Department of Psychological, Health, & Learning Sciences, University of Houston, 3657 Cullen Blvd, Houston, TX 77204, United States.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Cano', 'Affiliation': 'Department of Epidemiology, Florida International University, 11200 SW 8th St AHC5, Miami, FL 33199, United States.'}, {'ForeName': 'Ellen L', 'Initials': 'EL', 'LastName': 'Vaughan', 'Affiliation': 'Department of Counseling and Educational Psychology, Indiana University, 201 N Rose Ave, Bloomington, IN 47405, United States.'}, {'ForeName': 'Consuelo', 'Initials': 'C', 'LastName': 'Arbona', 'Affiliation': 'Department of Psychological, Health, & Learning Sciences, University of Houston, 3657 Cullen Blvd, Houston, TX 77204, United States.'}, {'ForeName': 'Saman', 'Initials': 'S', 'LastName': 'Essa', 'Affiliation': 'Department of Psychological, Health, & Learning Sciences, University of Houston, 3657 Cullen Blvd, Houston, TX 77204, United States.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Sanchez', 'Affiliation': 'Department of Psychological, Health, & Learning Sciences, University of Houston, 3657 Cullen Blvd, Houston, TX 77204, United States.'}, {'ForeName': 'Marcel A', 'Initials': 'MA', 'LastName': 'de Dios', 'Affiliation': 'Department of Psychological, Health, & Learning Sciences, University of Houston, 3657 Cullen Blvd, Houston, TX 77204, United States; HEALTH Research Institute, University of Houston, 4849 Calhoun Rd, Houston, TX 77204, United States. Electronic address: madedios@uh.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.01.016']
401,32057811,Randomized Trial of 2 Endoscopic Radial Artery Harvesting Devices-Immunofluorescence Assessment.,"BACKGROUND
Various devices are available for endoscopic radial artery harvesting during coronary artery bypass grafting. Thermal spread and graft damage, however, are common concerns. The aim of this study was to compare the MiFusion TLS2 system (Endotrust, Nettetal Germany) with direct heat technique and the LigaSure Maryland system (Medtronic, Dublin, Ireland) using advanced bipolar technique in a prospective randomized study.
METHODS
One hundred consecutive patients undergoing coronary artery bypass grafting with endoscopic radial artery harvesting were prospectively included and randomized 1:1. The proximal (brachial) ends of the grafts were analyzed using fluorescence microscopy with focus on graft integrity. In addition, harvesting time, graft sealing, residual bleeding, and incidence of neurological disorders were compared.
RESULTS
Patient age was 67 ± 8 years. Mean harvesting time was 26.5 ± 9 minutes for the TLS2 and 23.2 ± 8 minutes for the LigaSure (P = .049). Overall graft integrity was good in both groups. A significantly better graft integrity was observed in the LigaSure group (scale 0 to 3; 3 = best) with 2.5 ± 0.6 for TLS2 and 2.8 ± 0.4 for LigaSure (P = .031). LigaSure provided significantly better graft sealing (scale 0 to 2; 0 = best) with 0.6 ± 0.7 vs 1.0 ± 0.6 (TLS2) (P = .006) and less residual bleeding (scale 1 to 5; 1 = best) with 1.4 ± 0.6 vs 2.0 ± 0.9 (TLS2) (P < .001). Transient sensibility disorders were less frequently observed with LigaSure (2% vs 16%, P = .015).
CONCLUSIONS
Endoscopic radial artery harvesting can be performed with excellent results and good graft integrity using both devices. Compared with the MiFusion TLS2, the LigaSure device led to faster procedural times and resulted in better graft integrity. Along with providing a better seal, LigaSure was associated with less sensibility disorders.",2020,A significantly better graft integrity was observed in the LigaSure group (scale 0 to 3; 3=best) with 2.5±0.6 for TLS2™ and 2.8±0.4 for LigaSure (p=0.031).,"['Patient age was 67±8 years', '100 consecutive patients undergoing CABG with ERAH']","['MiFusion TLS2', 'MiFusion TLS2™ system (Endotrust, Germany) with direct heat technique and the LigaSure™ Maryland system (Medtronic, USA', 'endoscopic radial artery harvesting (ERAH', 'endoscopic radial artery harvesting devices - immunofluorescence assessment', 'coronary artery bypass grafting (CABG']","['Overall graft integrity', 'graft sealing', 'harvesting time, graft sealing, residual bleeding and incidence of neurological disorders', 'Mean harvesting time', 'Transient sensibility disorders', 'graft integrity', 'residual bleeding', 'sensibility disorders']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0079603', 'cui_str': 'Immunofluorescence'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",100.0,0.0361679,A significantly better graft integrity was observed in the LigaSure group (scale 0 to 3; 3=best) with 2.5±0.6 for TLS2™ and 2.8±0.4 for LigaSure (p=0.031).,"[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Van Linden', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Goethe University Hospital Frankfurt, Frankfurt. Electronic address: arnaud.vanlinden@kgu.de.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Hecker', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Goethe University Hospital Frankfurt, Frankfurt.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Lehmann-Grube', 'Affiliation': 'Medical School, Justus Liebig University Giessen, Giessen.'}, {'ForeName': 'Mani', 'Initials': 'M', 'LastName': 'Arsalan', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Goethe University Hospital Frankfurt, Frankfurt.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Richter', 'Affiliation': 'Department of Cardiac Surgery, Kerckhoff Clinic, Bad Nauheim, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Matzke', 'Affiliation': 'Max-Planck-Institute for Heart and Lung Research, Bad Nauheim, Germany.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Holubec', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Goethe University Hospital Frankfurt, Frankfurt.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Walther', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Goethe University Hospital Frankfurt, Frankfurt.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2019.12.063']
402,31103370,The Impact of a 4-Week Low-FODMAP and mNICE Diet on Nutrient Intake in a Sample of US Adults with Irritable Bowel Syndrome with Diarrhea.,"BACKGROUND
A diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) has gained increasing acceptance for the treatment of irritable bowel syndrome but safety concerns have been raised regarding nutritional adequacy. Changes in nutrient intake during the elimination phase of the low-FODMAP diet remain predominantly unknown.
OBJECTIVE
To determine changes in the mean reported daily nutrient content before and after 4 weeks of a low-FODMAP diet vs modified National Institute for Health and Clinical Excellence (mNICE) dietary intervention and to identify nutritional inadequacies based on comparison to the Dietary Reference Intakes in patients with irritable bowel syndrome-diarrhea subtype.
DESIGN
Post hoc analysis of a randomized controlled trial entailing a 4-week trial period comparing the low-FODMAP and mNICE diets.
PARTICIPANTS AND SETTING
A total of 78 patients (41 low FODMAP and 37 mNICE) meeting the Rome III criteria for irritable bowel syndrome-diarrhea subtype were consecutively recruited from gastroenterology and primary care clinics at the University of Michigan Medical Center between October 2012 and November 2015.
METHODS
Participants randomized to the low-FODMAP arm were instructed to decrease their dietary intake of FODMAPs, whereas participants randomized to the mNICE intervention arm were instructed to eat small frequent meals, avoid trigger foods, and avoid excess alcohol and caffeine.
MAIN OUTCOME MEASURES
Post hoc evaluation for presence of micronutrient deficiencies per Dietary Reference Intakes when implementing low-FODMAP vs mNICE dietary interventions. Dietary intake was analyzed via 3-day food diaries at baseline and during the final week of the assigned diet.
STATISTICAL ANALYSES PERFORMED
A post hoc analysis utilizing either a t test or χ 2 analysis was conducted between before and after data.
RESULTS
Both diets resulted in fewer daily kilocalories consumed, fewer number of daily meals consumed, and less daily carbohydrate intake. Among the patients following the low-FODMAP diet, there was a statistically significant decrease from baseline in several micronutrients, which was not observed in the mNICE cohort. However, these differences in the low-FODMAP group remained significant only for riboflavin after correcting for calorie-adjusted nutrient intake. Comparing Dietary Reference Intakes of participants pre- and postintervention, fewer patients met the Dietary Reference Intakes for thiamin and iron in the low FODMAP group, and for calcium and copper in the mNICE group.
CONCLUSIONS
During a 4-week dietary intervention, the mean daily intake of most micronutrients remained stable and within the Recommended Dietary Allowances for both diets. Although decrease in several micronutrients was observed with implementation of the low-FODMAP diet relative to the mNICE diet, most of these disappeared after adjusting for energy intake.",2020,"Both diets resulted in fewer daily kilocalories consumed, fewer number of daily meals consumed, and less daily carbohydrate intake.","['A total of 78 patients (41 low FODMAP and 37 mNICE) meeting the Rome III criteria for irritable bowel syndrome-diarrhea subtype were consecutively recruited from gastroenterology and primary care clinics at the University of Michigan Medical Center between October 2012 and November\xa02015', 'patients with irritable bowel syndrome-diarrhea subtype', 'Adults with Irritable Bowel Syndrome with Diarrhea', 'participants pre- and postintervention, fewer patients met the Dietary Reference Intakes for thiamin and iron in the low FODMAP group, and for calcium and copper in the mNICE group']","['riboflavin', 'mNICE intervention arm were instructed to eat small frequent meals, avoid trigger foods, and avoid excess alcohol and caffeine', '4-Week Low-FODMAP and mNICE Diet', 'low-FODMAP diet vs modified National Institute for Health and Clinical Excellence (mNICE) dietary intervention', 'low-FODMAP', 'low-FODMAP and mNICE diets']","['Nutrient Intake', 'Dietary intake', 'daily carbohydrate intake']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348898', 'cui_str': 'Irritable bowel syndrome with diarrhea (disorder)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C2985508', 'cui_str': 'Dietary Reference Intake'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}]","[{'cui': 'C0373720', 'cui_str': 'Vitamin B2'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4552346', 'cui_str': 'FODMAP diet'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]",78.0,0.0244793,"Both diets resulted in fewer daily kilocalories consumed, fewer number of daily meals consumed, and less daily carbohydrate intake.","[{'ForeName': 'Shanti', 'Initials': 'S', 'LastName': 'Eswaran', 'Affiliation': ''}, {'ForeName': 'Russell D', 'Initials': 'RD', 'LastName': 'Dolan', 'Affiliation': ''}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Ball', 'Affiliation': ''}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Jackson', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chey', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.03.003']
403,31576450,Comparison of pelvic floor muscle training isolated and associated with weight loss: a randomized controlled trial.,"PURPOSE
To analyze whether pelvic floor muscle training (PFMT) associated with weight loss (WL) is better than isolated PFMT to provide additional beneficial effects to urinary symptoms in women with MUI.
METHODS
A randomized, simple-blind parallel controlled trial was performed and included women with MUI aged between 40 and 65 years and body mass index between 25 and 40 kg/m 2 . The sample was randomized into two groups: 11 PFMT + WL and 11 PFMT. Data collection was performed in baseline and after interventions. The primary outcome was to investigate the loss of urine. Secondary aim includes PFM pressure and quality of life. PFMT was performed with two sets of eight repetitions in the first 4 weeks, and with three sets of eight repetitions in the final 4 weeks. The weight loss program was based on the calculation of total energy value needs. Data analysis was performed by SPSS 20.0 software and one-way ANCOVA.
RESULTS
22 volunteers participated in the study. There was no intergroup significant difference in post-intervention ICIQ-SF F(1, 19) = 7.115, p = 0.87, partial η 2 = 0.001; manometry F(1, 19) = 0.608, p = 0.44, partial η 2 = 0.003; pad test 1 h F(1, 19) = 0.185, p = 0.67, partial η 2 = 0.01; QoL F(1, 19) = 1.018, p = 0.32, partial η 2 = 0.05; and weight F(1, 19) = 0.251, p = 0.62, partial η 2 = 0.01.
CONCLUSIONS
Weight loss did not provide additional beneficial effects to PFMT in women with overweight or obesity grade I with MUI symptoms.",2019,"There was no intergroup significant difference in post-intervention ICIQ-SF F(1, 19) = 7.115, p = 0.87, partial η 2 = 0.001; manometry F(1, 19) = 0.608, p = 0.44, partial η 2 = 0.003; pad test 1 h F(1, 19) = 0.185, p = 0.67, partial η 2 = 0.01; QoL F(1, 19) = 1.018, p = 0.32, partial η 2 = 0.05; and weight F(1, 19) = 0.251, p = 0.62, partial η 2 = 0.01.
","['women with overweight or obesity grade I with MUI symptoms', 'women with MUI', '22 volunteers participated in the study', 'women with MUI aged between 40 and 65\xa0years and body mass index between 25 and 40\xa0kg']","['pelvic floor muscle training', 'PFMT\u2009+\u2009WL and 11 PFMT', 'PFMT', 'pelvic floor muscle training (PFMT']","['PFM pressure and quality of life', 'loss of urine', 'weight loss']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0042037'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",22.0,0.251451,"There was no intergroup significant difference in post-intervention ICIQ-SF F(1, 19) = 7.115, p = 0.87, partial η 2 = 0.001; manometry F(1, 19) = 0.608, p = 0.44, partial η 2 = 0.003; pad test 1 h F(1, 19) = 0.185, p = 0.67, partial η 2 = 0.01; QoL F(1, 19) = 1.018, p = 0.32, partial η 2 = 0.05; and weight F(1, 19) = 0.251, p = 0.62, partial η 2 = 0.01.
","[{'ForeName': 'Maria Clara Eugênia', 'Initials': 'MCE', 'LastName': 'de Oliveira', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Vanessa Cristina', 'Initials': 'VC', 'LastName': 'de Oliveira de Lima', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Pegado', 'Affiliation': 'Graduate Program in Rehabilitation Science, Federal University of Rio Grande do Norte, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Edson Meneses', 'Initials': 'EM', 'LastName': 'Silva-Filho', 'Affiliation': 'Graduate Program in Rehabilitation Science, Federal University of Rio Grande do Norte, Rio Grande do Norte, Brazil. meneses.edson@yahoo.com.br.'}, {'ForeName': 'Ana Paula Trussardi', 'Initials': 'APT', 'LastName': 'Fayh', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Maria Thereza', 'Initials': 'MT', 'LastName': 'Micussi', 'Affiliation': 'Health Science Center, Federal University of Rio Grande do Norte, Rio Grande do Norte, Brazil.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05319-1']
404,32188425,"Study protocol: watchful observation of patients with limited small cell lung cancer instead of the PCI-prospective, multi-center one-arm study.","BACKGROUND
Prophylactic cranial irradiation (PCI) is a current standard of care after confirmed response to radical chemoradiotherapy for limited disease small cell lung cancer (LD-SCLC). This standard is mostly based on results of old randomized studies when brain imaging with magnetic resonance (MRI) was not available. Survival benefit of PCI in extended disease SCLC was recently challenged by the results of randomized phase III study from Japan.
METHODS
Eighty patients with LD-SCLC after response to chest chemoradiotherapy will be enrolled. Patients will be followed up by brain MRI every 3 to 6 months up to 3 years. Neurocognitive function tests will be performed at baseline and after 12 and 24 months. Patients who develop brain metastases will be irradiated with stereotactic (SRT) or whole brain RT (WBRT). The primary endpoint is overall survival. The secondary endpoints are: response rate to radiotherapy of early detected brain metastases, analysis of efficacy of SRT and WBRT; assessment and analysis of neurocognitive functions and QoL in the studied cohorts: QLQ-C30 questionnaire and the California Verbal Learning Test, Color connection test, Benton visual retention test, and verbal fluency test will be carried out.
DISCUSSION
The results of this trial may contribute to changing of LD-SCLC clinical management by deescalating the treatment. There is a lack of prospective, recent studies in LD-SCLC patients with omission of PCI and modern radiation therapy technologies for developed brain metastases. The comprehensive neurocognitive function testing will help to assess the impact of modern radiotherapy (SRT) compared with WBRT and no-PCI in SCLC patients. A subgroup of long-term survivors, who will not develop brain metastases, will not be exposed to unnecessary brain irradiation with its deleterious consequences. The limitation of our study is a lack of parallel randomized control arm. This is a potential source of bias; however, randomized study will be difficult to complete for two major reasons: (1) limited population of LD-SCLC eligible for the study and (2) opinions of our patients, who after information and discussion about benefits and potential harms of PCI, often choose to omit PCI in our practice.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04168281, 19 Nov. 2019.",2020,Survival benefit of PCI in extended disease,"['SCLC patients', 'Eighty patients with LD-SCLC after response to chest chemoradiotherapy will be enrolled', 'Patients who develop brain metastases', 'patients with limited small cell lung cancer instead of the PCI-prospective, multi-center one-arm study']","['magnetic resonance (MRI', 'stereotactic (SRT) or whole brain RT (WBRT', 'radical chemoradiotherapy', 'PCI', 'modern radiotherapy (SRT', 'Prophylactic cranial irradiation (PCI', 'SCLC']","['response rate to radiotherapy of early detected brain metastases, analysis of efficacy of SRT and WBRT; assessment and analysis of neurocognitive functions and QoL in the studied cohorts: QLQ-C30 questionnaire and the California Verbal Learning Test, Color connection test, Benton visual retention test, and verbal fluency test will be carried out', 'overall survival', 'Neurocognitive function tests']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0079172', 'cui_str': 'Cranial Irradiation'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0589055', 'cui_str': 'TOMAL'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2143012', 'cui_str': 'Benton visual retention test (assessment scale)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",80.0,0.0936205,Survival benefit of PCI in extended disease,"[{'ForeName': 'Sergiusz', 'Initials': 'S', 'LastName': 'Nawrocki', 'Affiliation': 'Katedra Onkologii, Wydział Lekarski, Collegium Medicum, Uniwersytet Warmińsko-Mazurski w Olsztynie, Olsztyn, Poland. sergiusz.nawrocki@uwm.edu.pl.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sugajska', 'Affiliation': 'Katedra Onkologii, Wydział Lekarski, Collegium Medicum, Uniwersytet Warmińsko-Mazurski w Olsztynie, Olsztyn, Poland.'}]",BMC cancer,['10.1186/s12885-020-06721-8']
405,32199926,A randomized controlled noninferiority trial of reduced vs routine opioid prescription after prolapse repair.,"BACKGROUND
Given the accelerating opioid crisis in the United States and evidence that patients use fewer opioid tablets than prescribed, surgeons may choose to decrease prescribed quantities. The effect this may have on patient satisfaction with pain control after hospital discharge is unknown.
OBJECTIVE
The primary objective of this study was to compare patient satisfaction with postoperative pain control between patients receiving a routine or reduced quantity opioid prescription after prolapse repair. Secondary objectives included a comparison of opioid-related side-effects, the number of opioid tablets used, and the number of excess tablets prescribed between these groups.
STUDY DESIGN
This was a single-center, unmasked, 2-arm, randomized controlled noninferiority trial of women who underwent a prolapse repair with a planned overnight hospitalization. Patients were assigned randomly to 1 of 2 study arms: routine (28 tablets of oxycodone 5 mg) or reduced (5 tablets) prescription of opioid tablets. Patients were eligible if they were at least 18 years of age and undergoing a prolapse repair with an anticipated overnight hospital stay. Exclusion criteria included a history of chronic pain, preoperative opioid use, intolerance to study medication, or a score of ≥30 on the Pain Catastrophizing Scale. In addition to their opioid prescription, all patients received multimodal pain medications at discharge. Patients were asked to complete 6 weeks of diaries to record pain and medication use. The primary outcome (patient satisfaction) was collected as part of a postoperative survey completed at patients' routine postoperative visit 6 weeks after surgery. The sample size for noninferiority was calculated at 59 patients per group for a total of 118 patients.
RESULTS
One hundred eighteen patients were assigned randomly; the primary outcome was available for 116. The majority of patients were white, postmenopausal, and nonsmokers; the mean age was 62±10.4 years. The most common surgery was a hysterectomy with native tissue repair (n=71; 60%). One hundred ten patients (93%) were satisfied with postoperative pain control. Statistical analysis constructed for noninferiority showed that the difference between the groups was <15% (93% vs 93%; P=.005). Subjects in the reduced arm reported requiring an additional opioid prescription more frequently than in the routine arm (15% vs 2%; P=.01). Patients in the routine arm used more opioid tablets than the reduced arm (median, 3 [interquartile range, 0-14] vs 1 [interquartile range, 0-3]), but overall opioid utilization was low. As such, patients in the routine arm had significantly more unused opioid tablets (median, 26 [interquartile range, 15-28] vs 4 [interquartile range, 2-5]).
CONCLUSION
Patient satisfaction with pain control was noninferior in patients who received a reduced quantity of opioid tablets after prolapse repair compared with those who received a routine prescription. A large quantity of excess opioid tablets was seen in both groups. Surgeons should consider prescribing 5-10 opioid tablets after prolapse repair surgery and consider applying these findings to postoperative prescribing after other gynecologic procedures.",2020,Patients in the routine arm used more opioid tablets than the reduced arm (median 3 [IQR 0-14] vs 1 [IQR 0-3]) but overall opioid utilization was low.,"['after Prolapse Repair', 'Patients were eligible if they were at least 18 years of age and undergoing a prolapse repair with an anticipated overnight hospital stay', 'Exclusion criteria included a history of chronic pain, preoperative opioid use, intolerance to study medication, or a score of 30 or greater on the Pain Catastrophizing Scale', 'women undergoing a prolapse repair with a planned overnight hospitalization', 'patients receiving a routine or reduced quantity opioid prescription after prolapse repair', '118 patients']","['hysterectomy with native tissue repair', 'Reduced Versus Routine Opioid Prescription', 'multimodal pain medications', 'routine (28 tablets of oxycodone 5mg) or reduced (5 tablets) prescription of opioid tablets']","['opioid tablets', 'requiring an additional opioid prescription', 'comparison of opioid-related side effects, number of opioid tablets used, and the number of excess tablets prescribed between these groups', 'patient satisfaction with postoperative pain control', 'unused opioid', 'postoperative pain control', 'overall opioid utilization']","[{'cui': 'C0856413', 'cui_str': 'Prolapse repair'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042153', 'cui_str': 'use'}]",118.0,0.391597,Patients in the routine arm used more opioid tablets than the reduced arm (median 3 [IQR 0-14] vs 1 [IQR 0-3]) but overall opioid utilization was low.,"[{'ForeName': 'Emily R W', 'Initials': 'ERW', 'LastName': 'Davidson', 'Affiliation': ""Center for Urogynecology & Pelvic Reconstructive Surgery, Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH. Electronic address: edavidson@mcw.edu.""}, {'ForeName': 'Marie Fidela R', 'Initials': 'MFR', 'LastName': 'Paraiso', 'Affiliation': ""Center for Urogynecology & Pelvic Reconstructive Surgery, Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH.""}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Walters', 'Affiliation': ""Center for Urogynecology & Pelvic Reconstructive Surgery, Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Propst', 'Affiliation': ""Center for Urogynecology & Pelvic Reconstructive Surgery, Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH.""}, {'ForeName': 'Beri', 'Initials': 'B', 'LastName': 'Ridgeway', 'Affiliation': ""Center for Urogynecology & Pelvic Reconstructive Surgery, Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Yao', 'Affiliation': 'Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Cecile A', 'Initials': 'CA', 'LastName': 'Ferrando', 'Affiliation': ""Center for Urogynecology & Pelvic Reconstructive Surgery, Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.03.017']
406,31822498,TBCRC 032 IB/II Multicenter Study: Molecular Insights to AR Antagonist and PI3K Inhibitor Efficacy in Patients with AR + Metastatic Triple-Negative Breast Cancer.,"PURPOSE
Preclinical data demonstrating androgen receptor (AR)-positive (AR + ) triple-negative breast cancer (TNBC) cells are sensitive to AR antagonists, and PI3K inhibition catalyzed an investigator-initiated, multi-institutional phase Ib/II study TBCRC032. The trial investigated the safety and efficacy of the AR-antagonist enzalutamide alone or in combination with the PI3K inhibitor taselisib in patients with metastatic AR + (≥10%) breast cancer.
PATIENTS AND METHODS
Phase Ib patients [estrogen receptor positive (ER + ) or TNBC] with AR + breast cancer received 160 mg enzalutamide in combination with taselisib to determine dose-limiting toxicities and the maximum tolerated dose (MTD). Phase II TNBC patients were randomized to receive either enzalutamide alone or in combination with 4 mg taselisib until disease progression. Primary endpoint was clinical benefit rate (CBR) at 16 weeks.
RESULTS
The combination was tolerated, and the MTD was not reached. The adverse events were hyperglycemia and skin rash. Overall, CBR for evaluable patients receiving the combination was 35.7%, and median progression-free survival (PFS) was 3.4 months. Luminal AR (LAR) TNBC subtype patients trended toward better response compared with non-LAR (75.0% vs. 12.5%, P = 0.06), and increased PFS (4.6 vs. 2.0 months, P = 0.082). Genomic analyses revealed subtype-specific treatment response, and novel FGFR2 fusions and AR splice variants.
CONCLUSIONS
The combination of enzalutamide and taselisib increased CBR in TNBC patients with AR + tumors. Correlative analyses suggest AR protein expression alone is insufficient for identifying patients with AR-dependent tumors and knowledge of tumor LAR subtype and AR splice variants may identify patients more or less likely to benefit from AR antagonists.",2020,"Luminal AR (LAR) TNBC subtype patients trended towards better response compared to non-LAR (75.0% vs. 12.5%, p=0.06), and increased PFS (4.6 vs. 2.0 months, p=0.082).","['Ib patients (ER+ or TNBC) with AR+ breast cancer', 'TNBC patients with AR+ tumors', 'patients with AR+ metastatic triple-negative breast cancer', 'patients with metastatic AR+ (≥10%) breast cancer', 'Phase II TNBC patients']","['enzalutamide', 'AR-antagonist enzalutamide alone or in combination with the PI3K inhibitor taselisib', 'AR antagonist and PI3K inhibitor efficacy', 'androgen receptor (AR)-positive (AR', 'enzalutamide alone or in combination with 4 mg taselisib until disease progression']","['clinical benefit rate (CBR', 'median progression-free survival (PFS', 'tolerated and the MTD', 'PFS', 'safety and efficacy', 'hyperglycemia and skin rash']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4053731'}, {'cui': 'C0034786', 'cui_str': 'Testosterone Receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}]",,0.0152657,"Luminal AR (LAR) TNBC subtype patients trended towards better response compared to non-LAR (75.0% vs. 12.5%, p=0.06), and increased PFS (4.6 vs. 2.0 months, p=0.082).","[{'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Lehmann', 'Affiliation': 'Department of Medicine, Vanderbilt University, Nashville, Tennessee. j.pietenpol@vumc.org vandana.abramson@vumc.org brian.d.lehmann@vumc.org.'}, {'ForeName': 'Vandana G', 'Initials': 'VG', 'LastName': 'Abramson', 'Affiliation': 'Department of Medicine, Vanderbilt University, Nashville, Tennessee. j.pietenpol@vumc.org vandana.abramson@vumc.org brian.d.lehmann@vumc.org.'}, {'ForeName': 'Melinda E', 'Initials': 'ME', 'LastName': 'Sanders', 'Affiliation': 'Department of Pathology, Microbiology and Immunology, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Mayer', 'Affiliation': 'Dana Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Tufia C', 'Initials': 'TC', 'LastName': 'Haddad', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nanda', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Van Poznak', 'Affiliation': 'Department of Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Storniolo', 'Affiliation': 'Department of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Nangia', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Paula I', 'Initials': 'PI', 'LastName': 'Gonzalez-Ericsson', 'Affiliation': 'Department of Pathology, Microbiology and Immunology, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Sanchez', 'Affiliation': 'Department of Medicine, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Kimberly N', 'Initials': 'KN', 'LastName': 'Johnson', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Abramson', 'Affiliation': 'Department of Radiology and Radiological Sciences, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.'}, {'ForeName': 'Sheau-Chiann', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Center for Quantitative Sciences, Division of Cancer Biostatistics, Department of Biostatistics, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Shyr', 'Affiliation': 'Center for Quantitative Sciences, Division of Cancer Biostatistics, Department of Biostatistics, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Carlos L', 'Initials': 'CL', 'LastName': 'Arteaga', 'Affiliation': 'Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Pietenpol', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2170']
407,32209643,Maintaining quality of life in patients with chronic obstructive pulmonary disease (COPD) by extending the maintenance phase of community-based pulmonary rehabilitation: protocol for a randomised controlled trial (ComEx3 Study).,"INTRODUCTION
Pulmonary rehabilitation is a core component of the treatment of people with chronic obstructive pulmonary disease (COPD); however, the benefits gained diminish in the ensuing months. The optimal strategy for maintaining the benefits is unclear with weekly supervised maintenance exercise programmes proposed as one strategy. However, the long-term future of maintenance programs is dependent on quality evidence.
METHODS AND ANALYSIS
The ComEx3 randomised controlled trial will investigate the efficacy of extending a weekly supervised maintenance programme for an additional 6 months following an initial 10-week maintenance programme (intervention) by comparing with a control group who receive the same 10-week maintenance programme followed by 6 months of usual care. 120 participants with COPD will be recruited. Primary objective is to determine health-related quality of life over 12 months. Secondary objectives are to determine functional exercise capacity trajectory and to perform an economic evaluation of the intervention to the health system. Outcomes will be analysed for superiority according to intention-to-treat and per-protocol approaches.
ETHICS AND DISSEMINATION
Approval has been received from the relevant ethics committees. Findings will be disseminated in peer-reviewed journals and conferences, targeting those involved in managing people with COPD as well as those who develop policies and guidelines.
CLINICAL TRIAL REGISTRATION
ANZCTR 12618000933257.",2020,The ComEx3 randomised controlled trial will investigate the efficacy of extending a weekly supervised maintenance programme for an additional 6 months following an initial 10-week maintenance programme (intervention) by comparing with a control group who receive the same 10-week maintenance programme followed by 6 months of usual care.,"['patients with chronic obstructive pulmonary disease (COPD', '120 participants with COPD will be recruited', 'people with chronic obstructive pulmonary disease (COPD']",[],"['health-related quality of life', 'Maintaining quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]",120.0,0.166985,The ComEx3 randomised controlled trial will investigate the efficacy of extending a weekly supervised maintenance programme for an additional 6 months following an initial 10-week maintenance programme (intervention) by comparing with a control group who receive the same 10-week maintenance programme followed by 6 months of usual care.,"[{'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Lopez', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia derrick.lopez@uwa.edu.au.'}, {'ForeName': 'Nola', 'Initials': 'N', 'LastName': 'Cecins', 'Affiliation': 'Physiotherapy Department, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cockram', 'Affiliation': 'Community Physiotherapy Services, Perth, Western Australia, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Collins', 'Affiliation': 'Community Physiotherapy Services, Perth, Western Australia, Australia.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Landers', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Sanfilippo', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Briffa', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Fraser', 'Initials': 'F', 'LastName': 'Brims', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Geelhoed', 'Affiliation': 'School of Allied Health, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murray', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Lung Foundation Australia, Brisbane, Queensland, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Preen', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jenkins', 'Affiliation': 'School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia.'}]",BMJ open respiratory research,['10.1136/bmjresp-2019-000548']
408,32205684,"Post-operative Single-shot Epidural Fentanyl and Bupivacaine for Post-operative Analgesia after Lumbar Decompression: A Prospective, Double-Blind Randomized Study.","STUDY DESIGN
Randomized-clinical trial OBJECTIVE.: To evaluate the efficacy of the post-operative single-shot bolus of epidural Fentanyl and Bupivicaine in providing pain relief post-lumbar decompression surgery.
SUMMARY OF BACKGROUND DATA
Despite lumbar decompression's success in alleviating symptoms of sciatica, radiculopathy, and neurogenic claudication, transient back and buttock pain has been a common complaint postoperatively. Providing good post-operative pain alleviation predicts patient's quality of recovery.
METHODS
We performed a randomized, double-blinded, clinical trial. Forty-five patients scheduled for lumbar decompression for a years period who were randomly assigned to receive a postoperative bolus of 10-mL solution of 50 mcg of Fentanyl, 0.125% Bupivacaine, and 0.9% saline solution via an intraoperatively placed epidural catheter immediately after wound closure, before dressing application. Facial pain scale scores (from 0 to 10) were measured at 3 time points after surgery (fully awake at recovery room, transfer to ward, first postoperative day). Postoperative need for oral analgesics, time to independent ambulation, associated adverse events, and time to hospital discharge were also evaluated.
RESULTS
Pain scores were noted to be significantly lower at all time points in the epidural group (P < 0.001). In turn, they also received less on-demand oral pain medications than those in the control group (p = 0.000). The mean time to ambulation was 0.09 days in the epidural group and 0.91 days in the decompression-alone group (p = 0.000). Criteria for hospital discharge was usually met on Day 0 in the epidural and Day 1 in the control group (p = 0.000). Within the study period, only one infection was noted in the epidural group which necessitated additional lumbar spine surgery (4.3%). No adverse events or complications related to Fentanyl use were observed.
CONCLUSIONS
A postoperative bolus of Fentanyl and Bupivacaine is effective in reducing early postoperative pain without the related complications of opiod administration.
LEVEL OF EVIDENCE
2.",2020,"RESULTS
Pain scores were noted to be significantly lower at all time points in the epidural group (P < 0.001).","['Forty-five patients scheduled for lumbar decompression for a years period', 'Post-operative Analgesia after Lumbar Decompression']","['postoperative bolus of 10-mL solution of 50 mcg of Fentanyl, 0.125% Bupivacaine, and 0.9% saline solution', 'Post-operative Single-shot Epidural Fentanyl and Bupivacaine', 'Fentanyl and Bupivacaine', 'epidural Fentanyl and Bupivicaine']","['demand oral pain medications', 'mean time to ambulation', 'Criteria for hospital discharge', 'additional lumbar spine surgery', 'Pain scores', 'Postoperative need for oral analgesics, time to independent ambulation, associated adverse events, and time to hospital discharge', 'early postoperative pain', 'Facial pain scale scores']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0221776', 'cui_str': 'Painful mouth (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0015468', 'cui_str': 'Face Pain'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",45.0,0.4784,"RESULTS
Pain scores were noted to be significantly lower at all time points in the epidural group (P < 0.001).","[{'ForeName': 'Mannuel Feliciano B', 'Initials': 'MFB', 'LastName': 'Alican', 'Affiliation': ""Institue of Orthopedics and Sports Medicine, St. Luke's Medical Center Quezon City, Philippines.""}, {'ForeName': 'Mario R', 'Initials': 'MR', 'LastName': 'Ver', 'Affiliation': ""Institue of Orthopedics and Sports Medicine, St. Luke's Medical Center Quezon City, Philippines.""}, {'ForeName': 'Miguel Rafael D', 'Initials': 'MRD', 'LastName': 'Ramos', 'Affiliation': ""Institue of Orthopedics and Sports Medicine, St. Luke's Medical Center Quezon City, Philippines.""}, {'ForeName': 'Lulu Joan C', 'Initials': 'LJC', 'LastName': 'Mamaril', 'Affiliation': ""Department of Anesthesiology, St. Luke's Medical Center Quezon City, Philippines.""}]",Spine,['10.1097/BRS.0000000000003449']
409,32406964,"Prospective cohort study of child mouthing of faeces and fomites in Dhaka, Bangladesh (CHoBI7 Program).","OBJECTIVE
To characterise childhood mouthing and handling behaviours and to assess the association between hand-to-object and object-to-mouth contacts and diarrhoea prevalence in young children in urban Dhaka, Bangladesh.
METHODS
A prospective cohort study was conducted among 494 children under 5 years of age in Dhaka, Bangladesh. This study was nested within the randomised controlled trial of the Cholera Hospital-Based Intervention for 7 Days (CHoBI7) mobile health (mHealth) program. The CHoBI7 mHealth program focuses on promoting handwashing with soap and water treatment to diarrhoea patients and their household members through mobile messages and a single in person visit. Mouthing and handling of faeces and fomites among young children was measured by five-hour structured observation and caregiver reports. Diarrhoea surveillance data was collected monthly for 12 months.
RESULTS
Fifty five percent of caregivers reported that their child put a visibly dirty fomite (object or soil) in their mouth in the past week. Caregivers reported that 50% of children had mouthed visibly dirty objects, 26% had mouthed dirt, and 2% had mouthed faeces. Forty five percent of children were observed mouthing a visibly dirty fomite during structured observation, 40% of children were observed mouthing a visibly dirty object, 10% were observed mouthing soil, and one child (0.2%) was observed mouthing faeces. Mouthing of visibly dirty fomites was highest for children 12-18 months of age with 69% of these children having caregiver reports and 54% having observed events. Children with caregiver reports of mouthing faeces had a significantly higher odds of diarrhoea over the subsequent month (Odds Ratio: 4.54; 95% Confidence Interval: 1.06, 19.48).
CONCLUSION
These findings demonstrate that mouthing of contaminated fomites among young children is frequent in urban environments in Bangladesh, and that mouthing faeces is associated with a significantly higher odds of diarrhoea. Interventions are urgently needed to protect young children from faecal pathogens in their play spaces.",2020,"Children with caregiver reports of mouthing feces had significantly higher odds of diarrhea over the subsequent month (Odds Ratio: 4.54; 95% Confidence Interval: 1.06, 19.48).
","['young children in urban Dhaka', 'young children', 'Child Mouthing of Feces and Fomites in Urban Dhaka, Bangladesh (CHoBI7 Program', '494 children under 5 years of age in Dhaka, Bangladesh']",['Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) mobile health (mHealth) program'],"['diarrhea', 'visibly dirty objects', 'diarrhea prevalence', 'visibly dirty fomite (object or soil', 'Diarrhea surveillance data', 'visibly dirty fomite']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1008855', 'cui_str': 'Fomites'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0008354', 'cui_str': 'Cholera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0008354', 'cui_str': 'Cholera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1008855', 'cui_str': 'Fomites'}, {'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}]",494.0,0.0478912,"Children with caregiver reports of mouthing feces had significantly higher odds of diarrhea over the subsequent month (Odds Ratio: 4.54; 95% Confidence Interval: 1.06, 19.48).
","[{'ForeName': 'Tahmina', 'Initials': 'T', 'LastName': 'Parvin', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ismat', 'Initials': 'I', 'LastName': 'Minhaj Uddin', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Md Sazzadul', 'Initials': 'MS', 'LastName': 'Islam Bhuyian', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Saxton', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'Zohura', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Marzia', 'Initials': 'M', 'LastName': 'Sultana', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Fatema-Tuz', 'Initials': 'FT', 'LastName': 'Johura', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shirajum', 'Initials': 'S', 'LastName': 'Monira', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Md Tasdik', 'Initials': 'MT', 'LastName': 'Hasan', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Nowshin', 'Initials': 'N', 'LastName': 'Papri', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Md Ahshanul', 'Initials': 'MA', 'LastName': 'Haque', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shwapon K', 'Initials': 'SK', 'LastName': 'Biswas', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Sack', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'Department of International Health, Johns Hopkins School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Munirul', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Christine Marie', 'Initials': 'CM', 'LastName': 'George', 'Affiliation': 'International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13413']
410,32406965,"Process evaluation for the delivery of a water, sanitation and hygiene mobile health program: findings from the randomised controlled trial of the CHoBI7 mobile health program.","OBJECTIVE
The Cholera-Hospital-Based Intervention for 7-days (CHoBI7) mobile health (mHealth) program delivers mobile messages to diarrhoea patient households promoting water treatment and handwashing with soap. The randomised controlled trial (RCT) of the CHoBI7 mHealth program demonstrated this intervention was effective in significantly reducing diarrhoea and stunting amoung young children. The objective of this study was to assess the implementation of the CHoBI7 mHealth program in delivering mHealth messages during this RCT.
METHODS
517 diarrhoea patient households with 1777 participants received weekly text, voice and interactive voice response (IVR) messages from the CHoBI7 mHealth program over the 12-month program period. The program process evaluation indicators were the following: the percentage of CHoBI7 mHealth messages received and fully listened to by program households (program fidelity and dose), and household members reporting receiving and sharing an mHealth message from the program in the past two weeks (program reach).
RESULTS
Ninety two percent of text messages were received by program households. Eighty three percent of voice and 86% of IVR messages sent were fully listened to by at least one household member. Eighty one percent of IVR quiz responses from households were answered correctly. Program households reported receiving a CHoBI7 mHealth message in the past two weeks at 79% of monthly household visits during the 12-month program. Seventy seven percent of participants reported sharing a program message with a spouse, 55% with a neighbour and 49% with a child during the program period.
CONCLUSION
There was high fidelity, dose and reach of mobile messages delivered for the CHoBI7 mHealth program. This study presents an approach for process evaluation that can be implemented to evaluate future mHealth programs.",2020,83% of voice and 86% of IVR messages sent were fully listened to by at least one household member.,"['young children', 'diarrhea patient households promoting water treatment and handwashing with soap', '517 diarrhea patient households received']","['CHoBI7 mHealth program', 'fully listened to by program households (program fidelity and dose), and beneficiaries reporting receiving and sharing a mHealth message from the program (program reach', 'Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7) mobile health (mHealth) program', 'weekly text, voice, and interactive voice response (IVR) messages from the CHoBI7 mHealth program']",['diarrhea and stunting'],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}]","[{'cui': 'C0008354', 'cui_str': 'Cholera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}]",,0.0465095,83% of voice and 86% of IVR messages sent were fully listened to by at least one household member.,"[{'ForeName': 'Md Sazzadul', 'Initials': 'MS', 'LastName': 'Islam Bhuyian', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Saxton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Hasan', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jahed', 'Initials': 'J', 'LastName': 'Masud', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'Zohura', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shirajum', 'Initials': 'S', 'LastName': 'Monira', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shwapon', 'Initials': 'S', 'LastName': 'Kumar Biswas', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tasdik Hasan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Tahmina', 'Initials': 'T', 'LastName': 'Parvin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ismat', 'Initials': 'I', 'LastName': 'Minhaj', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Kazi', 'Initials': 'K', 'LastName': 'Md Zillur Rahman', 'Affiliation': 'University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Nowshin', 'Initials': 'N', 'LastName': 'Papri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mahamud-Ur', 'Initials': 'MU', 'LastName': 'Rashid', 'Affiliation': 'University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Lubaba', 'Initials': 'L', 'LastName': 'Sharin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Teman', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Thomas', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Alland', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Labrique', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Sack', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Munirul', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh(icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Christine Marie', 'Initials': 'CM', 'LastName': 'George', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13414']
411,32406989,Diarrhoeal disease knowledge among diarrhoea patient housholds: findings from the randomised controlled trial of the Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7) mobile health program.,"OBJECTIVE
The objective of this study was to evaluate the impact of the Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7) handwashing with soap and water treatment mobile health (mHealth) program on diarrhoeal disease knowledge among diarrhoea patients and their household members in urban Dhaka, Bangladesh.
METHODS
A cluster-randomised controlled trial of the CHoBI7 mHealth program was conducted among diarrhoea patient households in Dhaka, Bangladesh. Patients were randomised to three arms: standard recommendation on oral rehydration solution use; health facility delivery of CHoBI7 plus mHealth (weekly voice and text messages) (no home visits); and health facility delivery of CHoBI7 plus two home visits and mHealth. An open-ended questionnaire was administered to 1468 participants 12 years of age or older on diarrhoeal disease transmission and prevention. These items were combined to form a diarrhoeal disease knowledge score measured at baseline and at a 1 week, 6 month and 12 month follow-up.
RESULTS
At baseline, when participants were asked to report three ways diarrhoeal diseases were spread 37% (546/1468) of participants reported by water, 13% (187/1468) by lack of handwashing and 4% (53/1468) by food not being covered properly. At baseline when asked to name three ways diarrhoeal diseases could be prevented, 35% (515/1468) of participants reported safe water, and 16% (228/1468) reported handwashing with soap. At the 12-month follow-up, the overall diarrhoeal disease knowledge score was significantly higher in the mHealth with no home visits arm (score coefficient: 0.69, 95% Confidence Interval: 0.36, 1.01, P < 0.0001) and the mHealth with two home visits arm (score coefficient: 1.18, 95% CI: 0.87, 1.49, P < 0.0001) compared with the standard recommendation arm.
CONCLUSION
The CHoBI7 mHealth program significantly increased knowledge of diarrhoeal disease transmission and prevention among diarrhoea patients and their household members 12 months after in-person visits for program delivery were conducted.",2020,"At the 12 month follow-up, the overall diarrhea knowledge score was significantly higher in mHealth with no home visits arm (score coefficient: 0.69, 95% Confidence Interval: 0.36, 1.01, p<0.0001) and the mHealth with two home visits arm (score coefficient:","['diarrhea patients and their household members in urban Dhaka', 'diarrhea patient households in Dhaka, Bangladesh', 'diarrhea patient households', 'Household Members of Diarrhea Patients', '1468 participants 12 years of age or older on diarrheal disease transmission and prevention']","['CHoBI7 mHealth program', 'Cholera-Hospital-Based-Intervention-for-7 Days (CHoBI7) Mobile Health Program', 'Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7) handwashing with soap and water treatment mobile health (mHealth) program', 'standard recommendation on oral rehydration solution use; health facility delivery of CHoBI7 plus mHealth (no home visits); and health facility delivery of CHoBI7 plus two home visits and mHealth']","['diarrheal disease knowledge', 'overall diarrhea knowledge score', 'diarrheal disease knowledge score']","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0008354', 'cui_str': 'Cholera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0078516', 'cui_str': 'World Health Organization oral rehydration solution'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}]","[{'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.131471,"At the 12 month follow-up, the overall diarrhea knowledge score was significantly higher in mHealth with no home visits arm (score coefficient: 0.69, 95% Confidence Interval: 0.36, 1.01, p<0.0001) and the mHealth with two home visits arm (score coefficient:","[{'ForeName': 'Jahed', 'Initials': 'J', 'LastName': 'Masud', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Md Sazzadul', 'Initials': 'MS', 'LastName': 'Islam Bhuyian', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Shwapon', 'Initials': 'S', 'LastName': 'Kumar Biswas', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'Zohura', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Nowshin', 'Initials': 'N', 'LastName': 'Papri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Fahmida', 'Initials': 'F', 'LastName': 'Dil Farzana', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Tahmina', 'Initials': 'T', 'LastName': 'Parvin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Shirajum', 'Initials': 'S', 'LastName': 'Monira', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Munirul', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Christine Marie', 'Initials': 'CM', 'LastName': 'George', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13415']
412,31520258,Auricular acupuncture as effective pain relief after episiotomy: a randomized controlled pilot study.,"PURPOSE
Previously, pain treatment following episiotomy has relied on non-steroid anti-inflammatory drugs as analgesics, whose use during breastfeeding remains controversial due of their transfer to the child.
METHODS
This was a pilot randomized parallel single-center study aiming to evaluate the effects of auricular acupuncture on pain relief after episiotomy. The primary outcome was reduction of pain intensity using visual analogue scale (VAS) scores during the first three postpartum days. The patients were allocated to either of the groups by using a heads-tails binary result coin toss method and the allocation was not masked. The study was completed after including 60 healthy women that underwent mediolateral episiotomy performed during vaginal delivery, with 29 receiving acupuncture therapy and 31 not receiving acupuncture therapy for pain relief. Oral analgesic therapy was made available per request for all patients.
RESULTS
This study showed that subjective experience of pain was significantly reduced in the acupuncture group on the second and third postpartum days (P = 0.004, P = 0.005, P = 0.22). There were no adverse effects of acupuncture noted.
CONCLUSIONS
Our findings confirm that auricular acupuncture therapy may be a valuable adjunct to analgesic therapy in patients undergoing episiotomy during vaginal delivery. The results prompt a question whether our current 'best practice' may yet be improved.",2019,"There were no adverse effects of acupuncture noted.
","['60 healthy women that underwent', 'after episiotomy', 'patients undergoing episiotomy during vaginal delivery']","['acupuncture', 'auricular acupuncture therapy', 'auricular acupuncture', 'mediolateral episiotomy performed during vaginal delivery, with 29 receiving acupuncture therapy and 31 not receiving acupuncture therapy', 'Oral analgesic therapy', 'Auricular acupuncture']","['effective pain relief', 'pain relief', 'subjective experience of pain', 'reduction of pain intensity using visual analogue scale (VAS) scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0752217', 'cui_str': 'Auricular Acupuncture'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral (qualifier value)'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0412784', 'cui_str': 'Analgesic technique (procedure)'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",60.0,0.130774,"There were no adverse effects of acupuncture noted.
","[{'ForeName': 'Katarina Kličan', 'Initials': 'KK', 'LastName': 'Jaić', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Management, University Hospital Center Sestre Milosrdnice, Zagreb, Croatia.'}, {'ForeName': 'Tihana Magdić', 'Initials': 'TM', 'LastName': 'Turković', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Management, University Hospital Center Sestre Milosrdnice, Zagreb, Croatia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Pešić', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Management, University Hospital Center Sestre Milosrdnice, Zagreb, Croatia.'}, {'ForeName': 'Ivka', 'Initials': 'I', 'LastName': 'Djaković', 'Affiliation': 'Clinical Department of Gynecology and Obstetrics, University Hospital Center Sestre Milosrdnice, Zagreb, Croatia.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Košec', 'Affiliation': 'Clinical Department of Gynecology and Obstetrics, University Hospital Center Sestre Milosrdnice, Zagreb, Croatia.'}, {'ForeName': 'Andro', 'Initials': 'A', 'LastName': 'Košec', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Center Sestre Milosrdnice, Vinogradska cesta 29, Zagreb, Croatia. andro.kosec@yahoo.com.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05283-w']
413,32145041,"Dose-dependent naloxone-induced morphine withdrawal symptoms in opioid-dependent males-a double-blinded, randomized study.","AIMS
Oral opioid preparations combined with naloxone are intended to induce a transient acute withdrawal syndrome to avoid intravenous misuse. This trial aimed to establish an appropriate morphine-naloxone dose ratio for an abuse-deterrent oral opioid formulation.
METHODS
In a randomized, double-blinded, 2 × 2 cross-over trial, 43 patients with opioid use disorder were challenged with intravenous morphine HCl Ph.Eur. (75 mg; [morphine mono]) or morphine HCl Ph.Eur. and naloxone HCl Ph.Eur. at ratios of 100:1 (75 mg: 0.75 mg; [morphine-naloxone 100:1]) or 200:1 (75 mg: 0.375 mg; [morphine-naloxone 200:1]). Acute naloxone-induced opioid withdrawal was evaluated using subjective (Short Opiate Withdrawal Scale-German [SOWS-G]) and observer-rated (Objective Opiate Withdrawal Scale [OOWS], Wang scale) questionnaires, and physiological parameters. For statistical analysis, the area under the curve between baseline and 20 minutes after drug administration of the outcome variables was calculated.
RESULTS
Intravenous morphine-naloxone caused rapid withdrawal symptoms. Coadministration of naloxone dose-dependently (morphine-naloxone 100:1 > morphine-naloxone 200:1) increased SOWS-G, OOWS and Wang Scale area under the curve when compared to morphine mono, respectively (all P < .0001). A similar response was detectable for changes of pupil diameter. Blood pressure and respiratory rate changed heterogeneously, and heart rate was unaltered by morphine without or with naloxone.
CONCLUSION
Morphine-naloxone 100:1 effectively suppresses the pleasurable effects of intravenous morphine and results in an aversive withdrawal reaction. A lower naloxone concentration as used in morphine-naloxone 200:1 does not appear to be appropriate to prevent intravenous morphine misuse.",2020,"Coadministration of naloxone dose-dependently (morphine-naloxone 100:1 > morphine-naloxone 200:1) increased SOWS-G, OOWS and Wang Scale area under the curve when compared to morphine mono, respectively (all P < .0001).","['43 patients with opioid use disorder', 'withdrawal symptoms in opioid-dependent males']","['Morphine-naloxone', 'naloxone', 'naloxone dose-dependently (morphine-naloxone 100:1 > morphine-naloxone', 'morphine-naloxone', 'morphine HCl Ph.Eur. and naloxone HCl Ph.Eur', 'intravenous morphine HCl Ph.Eur', 'morphine', 'naloxone-induced morphine', 'Acute naloxone']","['Blood pressure and respiratory rate changed heterogeneously, and heart rate', 'aversive withdrawal reaction', 'SOWS-G, OOWS and Wang Scale area under the curve', 'rapid withdrawal symptoms', 'subjective (Short Opiate Withdrawal Scale-German [SOWS-G]) and observer-rated (Objective Opiate Withdrawal Scale [OOWS], Wang scale) questionnaires, and physiological parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0443985', 'cui_str': 'Flinders medical center-7 marker (substance)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0857405', 'cui_str': 'Withdrawal reaction'}, {'cui': 'C0222045'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",43.0,0.270251,"Coadministration of naloxone dose-dependently (morphine-naloxone 100:1 > morphine-naloxone 200:1) increased SOWS-G, OOWS and Wang Scale area under the curve when compared to morphine mono, respectively (all P < .0001).","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Weisshaar', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brandt', 'Affiliation': 'Department of Applied Psychology: Work, Education & Economy, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Litschauer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Safoura', 'Initials': 'S', 'LastName': 'Sheik-Rezaei', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Moser', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Nirnberger', 'Affiliation': 'Bioconsult GmbH, Breitenfurt, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kühberger', 'Affiliation': 'G. L. Pharma GmbH, Lannach, Austria.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bauer', 'Affiliation': 'G. L. Pharma GmbH, Lannach, Austria.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Firbas', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Gouya', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wolzt', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Fischer', 'Affiliation': 'Center for Public Health, Medical University of Vienna, Vienna, Austria.'}]",British journal of clinical pharmacology,['10.1111/bcp.14271']
414,32207209,Effect of probiotics during vonoprazan-containing triple therapy on gut microbiota in Helicobacter pylori infection: A randomized controlled trial.,"BACKGROUND
Probiotics are beneficial to patients with Helicobacter pylori infections by modulating the gut microbiota. Biofermin-R (BFR) is a multiple antibiotic-resistant lactic acid bacteria preparation of Enterococcus faecium 129 BIO 3B-R and is effective in normalizing the gut microbiota when used in combination with antibiotics. This study aimed to determine the effect of BFR in combination with vonoprazan (VPZ)-based therapy on gut microbiota.
METHODS
Patients with positive urinary anti-H pylori antibody test (primary test) and fecal H pylori antigen test (secondary test) were examined. Patients in group 1 (BFR - ) received VPZ (20 mg twice daily), amoxicillin (750 mg twice daily), and clarithromycin (400 mg twice daily) for 7 days. Patients in group 2 (BFR + ) received BFR (3 tablets/day) for 7 days, in addition to the aforementioned treatments. Following treatment, the relative abundance, α-diversity, and β-diversity of gut microbiota were assessed.
RESULTS
Supplementation with BFR prevented the decrease in a-diversity after eradication therapy (Day 7). β-diversity was similar between groups. The incidence rate of diarrhea was non-significantly higher in the BFR - than in the BFR + group (73.1% vs 56.5%; P = .361). Stool consistency was comparable in the BFR + group on Days 7 and 1 (3.86 ± 0.95 vs 3.86 ± 1.46; P = .415).
CONCLUSION
Biofermin-R combined with VPZ-based therapy resulted in higher microbial α-strain diversity and suppressed stool softening during H pylori eradication therapy.",2020,Stool consistency was comparable in the BFR + group on Days 7 and 1 (3.86 ± 0.95 vs 3.86 ± 1.46;,"['Patients with positive urinary anti-H pylori antibody test (primary test) and fecal H pylori antigen test (secondary test) were examined', 'Helicobacter pylori infection', 'patients with Helicobacter pylori infections']","['clarithromycin', 'VPZ', 'probiotics during vonoprazan-containing triple therapy', 'vonoprazan (VPZ)-based therapy', 'amoxicillin', 'Biofermin-R combined with VPZ-based therapy', 'Biofermin-R (BFR', 'BFR']","['β-diversity', 'diversity', 'microbial α-strain diversity and suppressed stool softening', 'incidence rate of diarrhea', 'Stool consistency', 'relative abundance, α-diversity, and β-diversity of gut microbiota']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0221137', 'cui_str': 'Blood group antibody ISBT H1'}, {'cui': 'C0580327', 'cui_str': 'Antibody studies (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0729856', 'cui_str': 'Antigen test (procedure)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}]","[{'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}]",,0.0560174,Stool consistency was comparable in the BFR + group on Days 7 and 1 (3.86 ± 0.95 vs 3.86 ± 1.46;,"[{'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Kakiuchi', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Mizoe', 'Affiliation': 'Department of Gastroenterology, Kahan Hospital, Karatsu, Japan.'}, {'ForeName': 'Kentaroh', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Gastroenterology, Yamamoto Memorial Hospital, Imari, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Imamura', 'Affiliation': 'Department of Gastroenterology, Imamura Hospital, Tosu, Japan.'}, {'ForeName': 'Kazutoshi', 'Initials': 'K', 'LastName': 'Hashiguchi', 'Affiliation': 'Department of Gastroenterology, Imamura Hospital, Tosu, Japan.'}, {'ForeName': 'Hiroharu', 'Initials': 'H', 'LastName': 'Kawakubo', 'Affiliation': 'Department of Gastroenterology, ImariArita Kyoritsu Hospital, Nishimatsuura, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastroenterology, Ureshino Medical Center, Ureshino, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Fujioka', 'Affiliation': 'Department of Gastroenterology, Fujioka Hospital, Saga, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Nakayama', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Masumi', 'Initials': 'M', 'LastName': 'Okuda', 'Affiliation': 'Department of Pediatrics, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Muneaki', 'Initials': 'M', 'LastName': 'Matsuo', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Saga University, Saga, Japan.'}]",Helicobacter,['10.1111/hel.12690']
415,32207359,Oxytocin and vasopressin modulation of prisoner's dilemma strategies.,"BACKGROUND
The neuropeptides oxytocin and vasopressin have been repeatedly implicated in social decision making by enhancing social salience and, generally, cooperation. The iterated and sequential version of the prisoner's dilemma (PD) game is a social dilemma paradigm eliciting strategies of cooperation versus competition.
AIMS
We aimed to characterise the role of PD players' sex, game partner type (computer vs. human) and oxytocin or vasopressin inhalation on the player's strategy preference.
METHODS
Participants (153 men; 151 women) were randomised to intranasal 24 IU oxytocin, 20 IU vasopressin or placebo, double-blind, and played the PD. We examined main and interactive effects of sex, drug and partner type on strategy preference.
RESULTS
We found a pervasive preference for a tit-for-tat strategy (i.e. general sensitivity to the partner's choices) over unconditional cooperation, particularly when against a human rather than a computer partner. Oxytocin doubled this sensitivity in women (i.e. the preference for tit-for-tat over unconditional cooperation strategies) when playing against computers, which suggests a tendency to anthropomorphise them, and doubled women's unconditional cooperation preference when playing against humans. Vasopressin doubled sensitivity to the partner's previous choices (i.e. for tit-for-tat over unconditional cooperation) across sexes and partner types.
CONCLUSIONS
These findings suggest that women may be more sensitive to oxytocin's social effects of anthropomorphism of non-humans and of unconditional cooperation with humans, which may be consistent with evolutionary pressures for maternal care, and that vasopressin, irrespective of sex and partner type, may be generally sensitising humans to others' behaviour.",2020,"The iterated and sequential version of the prisoner's dilemma (PD) game is a social dilemma paradigm eliciting strategies of cooperation versus competition.
",['Participants (153 men; 151 women'],"['oxytocin or vasopressin inhalation', 'intranasal 24\u2009IU oxytocin, 20\u2009IU vasopressin or placebo, double-blind, and played the PD', 'Oxytocin', 'Vasopressin']",[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0201849', 'cui_str': 'Antidiuretic hormone measurement (procedure)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0032214', 'cui_str': 'Play'}]",[],153.0,0.0510137,"The iterated and sequential version of the prisoner's dilemma (PD) game is a social dilemma paradigm eliciting strategies of cooperation versus competition.
","[{'ForeName': 'Maria Leonor', 'Initials': 'ML', 'LastName': 'Neto', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Marília', 'Initials': 'M', 'LastName': 'Antunes', 'Affiliation': 'Centro de Estatística e Aplicações e Departamento de Estatística e Investigação Operacional, Faculdade de Ciências, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Lopes', 'Affiliation': 'INESC-ID, Instituto Superior Técnico, Lisbon, Portugal.'}, {'ForeName': 'Duarte', 'Initials': 'D', 'LastName': 'Ferreira', 'Affiliation': 'Instituto de Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Rilling', 'Affiliation': 'Department of Anthropology, Emory University, Atlanta, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Prata', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120913145']
416,31029650,"Nutrient Intake, Diet Quality, and Diet Diversity in Irritable Bowel Syndrome and the Impact of the Low FODMAP Diet.","BACKGROUND
Individuals with irritable bowel syndrome (IBS) may modify their diet, which may pose nutritional risk. Further, some dietary approaches, such as a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs), are restrictive and may contribute to nutritional inadequacy.
OBJECTIVE
Our aim was to evaluate habitual nutrient intake, diet quality, and diversity in IBS and the effect of a 4-week low FODMAP diet on these parameters compared with controls.
DESIGN
Data from two randomized controlled trials were included for this secondary analysis. Participants were randomized to low FODMAP diet (n=63) or control diet (sham diet n=48, habitual diet n=19).
PARTICIPANTS/SETTING
Participants included 130 individuals with IBS referred to a tertiary center in London, UK between January 2010 to June 2011 and January 2013 to November 2014.
INTERVENTION
Participants in one trial were randomized to receive either low FODMAP dietary counseling or sham control dietary counseling. In the other, they were randomized to receive low FODMAP dietary counseling or to continue habitual diet. All advice was provided by a specialist dietitian.
MAIN OUTCOME MEASURES
Habitual (usual) dietary intake at baseline (n=130) and after a 4-week intervention period was measured using 7-day food records.
STATISTICAL ANALYSES PERFORMED
Analysis of covariance and χ 2 tests evaluated differences across groups at 4 weeks.
RESULTS
When examining habitual intake of individuals with IBS, fiber intake was low, with only 6 (5%) achieving the target (30 g/day). In those receiving low FODMAP advice, there was no difference in intake of most nutrients compared with controls. However, there was lower intake of starch (109 g/day) vs habitual control diet (128 g/day; P=0.030), and higher intake of vitamin B-12 (6.1 μg/day) vs habitual (3.9 μg/day) and sham control diets (4.7 μg/day; P<0.01). Overall scores for diet quality were lower after low FODMAP advice vs habitual control diet (P<0.01).
CONCLUSION
This study demonstrates many individuals with IBS fail to meet dietary reference values for multiple nutrients. A 4-week low FODMAP diet, when delivered by a specialist dietitian, does not impact on intake of most nutrients or diet diversity but decreases diet quality compared with control diets.",2020,"Overall scores for diet quality were lower after low FODMAP advice vs habitual control diet (P<0.01).
","['Participants included 130 individuals with IBS referred to a tertiary center in London, UK between January 2010 to June 2011 and January 2013 to November\xa02014', 'Individuals with irritable bowel syndrome (IBS']","['low FODMAP diet', 'low FODMAP dietary counseling or sham control dietary counseling', 'low FODMAP dietary counseling', '4-week low FODMAP diet', 'control diet (sham diet n=48, habitual diet n=19']","['higher intake of vitamin B-12', 'intake of most nutrients', 'diet quality', 'Nutrient Intake, Diet Quality, and Diet Diversity', 'Habitual (usual) dietary intake', 'habitual nutrient intake, diet quality, and diversity in IBS', 'Overall scores for diet quality', 'lower intake of starch']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4552346', 'cui_str': 'FODMAP diet'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038179', 'cui_str': 'Starch'}]",130.0,0.0558268,"Overall scores for diet quality were lower after low FODMAP advice vs habitual control diet (P<0.01).
","[{'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Staudacher', 'Affiliation': ''}, {'ForeName': 'Frances S E', 'Initials': 'FSE', 'LastName': 'Ralph', 'Affiliation': ''}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Irving', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Whelan', 'Affiliation': ''}, {'ForeName': 'Miranda C E', 'Initials': 'MCE', 'LastName': 'Lomer', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.01.017']
417,31512148,"CardioMEMS, the real progress in heart failure home monitoring.","The burden of hospitalizations driven by exacerbation of acute heart failure remains unacceptably high. The associated use of hospital resources drives increasing patient, caregiver, and economic costs. Noninvasive telemedical systems investigated in randomized controlled trials have failed to demonstrate to reduce hospitalization rates probably because of the indirect (non-linear) relationship of the measured biological signals with the patient congestion status. Instead, there is increasing evidence that direct measure of intracardiac and pulmonary artery pressure can effectively guide heart failure management and reduce hospitalizations. Early studies adopting implantable hemodynamic monitors in the right heart unveiled the potential of pressure-based heart failure management, whereas subsequent investigations showed the powerful preemptive approach for heart failure exacerbations. One large randomized trial (CHAMPION) proved that a direct pulmonary pressure monitor system (CardioMEMS) substantially reduced heart failure hospitalizations in subjects randomized to active pulmonary pressure-guided management. The system monitoring safety and efficacy were also excellent. The study proved that early management in response to increased pulmonary pressure is able to provide the most effective therapeutic intervention to prevent heart failure exacerbations.",2020,One large randomized trial (CHAMPION) proved that a direct pulmonary pressure monitor system (CardioMEMS) substantially reduced heart failure hospitalizations in subjects randomized to active pulmonary pressure-guided management.,['subjects randomized to active pulmonary pressure-guided management'],['direct pulmonary pressure monitor system (CardioMEMS'],"['heart failure hospitalizations', 'hospitalization rates']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0182377', 'cui_str': 'Pressure monitor (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",,0.0433742,One large randomized trial (CHAMPION) proved that a direct pulmonary pressure monitor system (CardioMEMS) substantially reduced heart failure hospitalizations in subjects randomized to active pulmonary pressure-guided management.,"[{'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Gronda', 'Affiliation': ""Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico di Milano UOC di Nefrologia, Dialisi e Trapianto Renale dell'adulto Dipartimento Di Medicina e Specialità Mediche, Milan, Italy. edoardo.gronda@gmail.com.""}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Vanoli', 'Affiliation': 'Department of Molecular Medicine, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Zorzi', 'Affiliation': 'Department of Cardiac Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Corrado', 'Affiliation': 'Department of Cardiac Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}]",Heart failure reviews,['10.1007/s10741-019-09840-y']
418,32198520,Proactively Offered Text Messages and Mailed Nicotine Replacement Therapy for Smokers in Primary Care Practices: A Pilot Randomized Trial.,"INTRODUCTION
Proactive, population health cessation programs can guide efforts to reach smokers outside of the clinic to encourage quit attempts and treatment use.
AIMS AND METHODS
This study aimed to measure trial feasibility and preliminary effects of a proactive intervention offering text messages (TM) and/or mailed nicotine replacement therapy (NRT) to smokers in primary care clinics. From 2017 to 2019 we performed a pilot randomized trial comparing brief telephone advice (control: BA), TM, 2 weeks of mailed NRT, or both interventions (TM + NRT). Patients were identified using electronic health records and contacted proactively by telephone to assess interest in the study. We compared quit attempts, treatment use, and cessation in the intervention arms with BA.
RESULTS
Of 986 patients contacted, 153 (16%) enrolled (mean age 53 years, 57% female, 76% white, 11% black, 8% Hispanic, 52% insured by Medicaid) and 144 (94%) completed the 12-week assessment. On average, patients in the TM arms received 159 messages (99.4% sent, 0.6% failed), sent 19 messages, and stayed in the program for 61 days. In all groups, a majority of patients reported quit attempts (BA 67% vs. TM 86% [p = .07], NRT 81% [p = .18], TM + NRT 79% [p = .21]) and NRT use (BA 51% vs. NRT 83% [p = .007], TM 65% [p = .25], TM + NRT 76% [p = .03]). Effect estimates for reported 7-day abstinence were BA 10% versus TM 26% (p = .09), NRT 28% (p = .06), and TM + NRT 23% (p = .14).
CONCLUSIONS
Proactively offering TM or mailed nicotine medications was feasible among primary care smokers and a promising approach to promote quit attempts and short-term abstinence.
IMPLICATIONS
Proactive intervention programs to promote quit attempts outside of office visits among smokers enrolled in primary care practices are needed. TM have potential to engage smokers not planning to quit or to support smokers to make a planned quit attempt. This pilot study demonstrates the feasibility of testing a proactive treatment model including TM and/or mailed NRT to promote quit attempts, treatment use, and cessation among nontreatment-seeking smokers in primary care.
CLINICALTRIALS.GOV IDENTIFIER
NCT03174158.",2020,"Effect estimates for reported 7-day abstinence were BA 10% versus TM 26% (p=0.09), NRT 28% (p=0.06), and TM+NRT 23% (p=0.14).
","['smokers in primary care practices', 'From 2017-2019', '986 patients contacted, 153 (16%) enrolled (mean age 53 years, 57% female, 76% white, 11% black, 8% Hispanic, 52% insured by Medicaid) and 144 (94%) completed the 12-week assessment', 'smokers in primary care clinics', 'primary care smokers']","['proactive intervention offering text messages and/or mailed nicotine replacement therapy (NRT', 'nicotine medications', 'telephone advice (control: BA), text messages (TM), 2-weeks of mailed NRT, or both interventions (TM+NRT', 'nicotine replacement therapy']","['7-day abstinence', 'quit attempts']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.0423889,"Effect estimates for reported 7-day abstinence were BA 10% versus TM 26% (p=0.09), NRT 28% (p=0.06), and TM+NRT 23% (p=0.14).
","[{'ForeName': 'Gina R', 'Initials': 'GR', 'LastName': 'Kruse', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Tobacco Research and Treatment Center, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Haberer', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Lorien C', 'Initials': 'LC', 'LastName': 'Abroms', 'Affiliation': 'Department of Prevention and Community Health, Milken Institute School of Public Health, George Washington University, Washington, DC.'}, {'ForeName': 'Naysha N', 'Initials': 'NN', 'LastName': 'Shahid', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Howard', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa050']
419,32178640,Study protocol: a randomized controlled trial comparing the efficacy of therapist guided internet-delivered cognitive therapy (TG-iConquerFear) with augmented treatment as usual in reducing fear of cancer recurrence in Danish colorectal cancer survivors.,"BACKGROUND
Cognitive therapy has been shown to reduce fear of cancer recurrence (FCR), mainly in breast cancer survivors. The accessibility of cognitive behavioural interventions could be further improved by Internet delivery, but self-guided interventions have shown limited efficacy. The aim of this study is to test the efficacy of a therapist guided internet-delivered intervention (TG-iConquerFear) vs. augmented treatment as usual (aTAU) in Danish colorectal cancer survivors.
METHODS/DESIGN
A population-based randomized controlled trial (RCT) comparing TG-iConquerFear with aTAU (1:1) in n = 246 colorectal cancer survivors who suffer from clinically significant FCR (Fear of Cancer Recurrence Inventory Short Form (FCRI-SF) ≥ 22 and semi-structured interview). Evaluation will be conducted at 2 weeks, 3 and 6 months post-treatment and between-group differences will be evaluated. Long-term effects will be evaluated after one year. Primary outcome will be post-treatment FCR (FCRI-SF). Secondary outcomes are global overall health and global quality of life (Visual Analogue Scales 0-100), bodily distress syndrome (BDS checklist), health anxiety (Whiteley-6), anxiety (SCL4-anx), depression (SCL6-dep) and sickness absence and health expenditure (register data). Explanatory outcomes include: Uncertainty in illness (Mishels uncertainty of illness scale, short form, MUIS), metacognitions (MCQ-30 negative beliefs about worry subscale), and perceived risk of cancer recurrence (Visual analogue Scale 1-100).
DISCUSSION
This RCT will provide valuable information on the clinical and cost-effectiveness of TG-iConquerFear vs. aTAU for CRC survivors with clinical FCR, as well as explanatory variables that may act as outcome moderators or mediators.
TRIAL REGISTRATION
ClinicalTrials.gov; NCT04287218, registered 25.02.2020. https://clinicaltrials.gov/ct2/results?cond=&term=NCT04287218&cntry=&state=&city=&dist=.",2020,"The aim of this study is to test the efficacy of a therapist guided internet-delivered intervention (TG-iConquerFear) vs. augmented treatment as usual (aTAU) in Danish colorectal cancer survivors.
","['1:1) in n\u2009=\u2009246 colorectal cancer survivors who suffer from clinically significant FCR (Fear of Cancer Recurrence Inventory Short Form (FCRI-SF)\u2009≥\u200922 and semi-structured interview', 'Danish colorectal cancer survivors']","['therapist guided internet-delivered cognitive therapy (TG-iConquerFear', 'therapist guided internet-delivered intervention (TG-iConquerFear) vs. augmented treatment as usual (aTAU', 'https://clinicaltrials.gov/ct2/results?cond=&term=NCT04287218&cntry=&state=&city=&dist', 'TG-iConquerFear with aTAU']","[' Uncertainty in illness (Mishels uncertainty of illness scale, short form, MUIS), metacognitions (MCQ-30 negative beliefs about worry subscale), and perceived risk of cancer recurrence (Visual analogue Scale 1-100', 'fear of cancer recurrence (FCR', 'fear of cancer recurrence', 'post-treatment FCR (FCRI-SF', 'global overall health and global quality of life (Visual Analogue Scales 0-100), bodily distress syndrome (BDS checklist), health anxiety (Whiteley-6), anxiety (SCL4-anx), depression (SCL6-dep) and sickness absence and health expenditure (register data']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0222045'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0589513', 'cui_str': 'Meta-cognition'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer (finding)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034380'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0057472', 'cui_str': '1-(2-(dodecyloxy)ethyl)pyrrolidine hydrochloride'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0015318', 'cui_str': 'Health Expenditures'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]",246.0,0.279267,"The aim of this study is to test the efficacy of a therapist guided internet-delivered intervention (TG-iConquerFear) vs. augmented treatment as usual (aTAU) in Danish colorectal cancer survivors.
","[{'ForeName': 'Johanne Dam', 'Initials': 'JD', 'LastName': 'Lyhne', 'Affiliation': 'Department of Clinical Oncology, University Hospital of Southern Denmark, Vejle, Beriderbakken 4, 7100, Vejle, Denmark. Johanne.Dam.Lyhne@rsyd.dk.'}, {'ForeName': ""Allan ' Ben'"", 'Initials': ""A'B"", 'LastName': 'Smith', 'Affiliation': 'Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool, NSW, 2170, Australia.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Frostholm', 'Affiliation': 'Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Nørrebrogade 44, bygn. 4, 1, 8000, Aarhus C, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Fink', 'Affiliation': 'Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Nørrebrogade 44, bygn. 4, 1, 8000, Aarhus C, Denmark.'}, {'ForeName': 'Lars Henrik', 'Initials': 'LH', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Oncology, University Hospital of Southern Denmark, Vejle, Beriderbakken 4, 7100, Vejle, Denmark.'}]",BMC cancer,['10.1186/s12885-020-06731-6']
420,31884854,"Effects of Interleukin-1β Inhibition on Blood Pressure, Incident Hypertension, and Residual Inflammatory Risk: A Secondary Analysis of CANTOS.","While hypertension and inflammation are physiologically inter-related, the effect of therapies that specifically target inflammation on blood pressure is uncertain. The recent CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcomes Study) afforded the opportunity to test whether IL (interleukin)-1β inhibition would reduce blood pressure, prevent incident hypertension, and modify relationships between hypertension and cardiovascular events. CANTOS randomized 10 061 patients with prior myocardial infarction and hsCRP (high sensitivity C-reactive protein) ≥2 mg/L to canakinumab 50 mg, 150 mg, 300 mg, or placebo. A total of 9549 trial participants had blood pressure recordings during follow-up; of these, 80% had a preexisting diagnosis of hypertension. In patients without baseline hypertension, rates of incident hypertension were 23.4, 26.6, and 28.1 per 100-person years for the lowest to highest baseline tertiles of hsCRP ( P >0.2). In all participants random allocation to canakinumab did not reduce blood pressure ( P >0.2) or incident hypertension during the follow-up period (hazard ratio, 0.96 [0.85-1.08], P >0.2). IL-1β inhibition with canakinumab reduces major adverse cardiovascular event rates. These analyses suggest that the mechanisms underlying this benefit are not related to changes in blood pressure or incident hypertension. Clinical Trial Registration- URL: https://clinicaltrials.gov. Unique identifier: NCT01327846.",2020,"In all participants random allocation to canakinumab did not reduce blood pressure ( P >0.2) or incident hypertension during the follow-up period (hazard ratio, 0.96 [0.85-1.08], P >0.2).","['061 patients with prior myocardial infarction and hsCRP (high sensitivity C-reactive protein) ≥2 mg', 'A total of 9549 trial participants had blood pressure recordings during follow-up; of these, 80% had a preexisting diagnosis of hypertension']","['L to canakinumab 50 mg, 150 mg, 300 mg, or placebo', 'Interleukin-1β Inhibition', 'IL (interleukin)-1β inhibition']","['Blood Pressure, Incident Hypertension, and Residual Inflammatory Risk', 'blood pressure or incident hypertension', 'rates of incident hypertension', 'incident hypertension', 'blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.224736,"In all participants random allocation to canakinumab did not reduce blood pressure ( P >0.2) or incident hypertension during the follow-up period (hazard ratio, 0.96 [0.85-1.08], P >0.2).","[{'ForeName': 'Alexander Mk', 'Initials': 'AM', 'LastName': 'Rothman', 'Affiliation': 'From the Department of Cardiology, Chesterman Cardiothoracic Unit, Northern General Hospital, Sheffield, United Kingdom (A.M.K.R.).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'MacFadyen', 'Affiliation': ""Center for Cardiovascular Disease Prevention (J.M., R.J.G., P.M.R.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Thuren', 'Affiliation': 'Novartis Pharmaceutical Corporation, One Health Plaza, East Hanover, NJ (T.T.).'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': 'Centre for Prevention of Stroke and Dementia, Department of Clinical Neurosciences, University of Oxford, United Kingdom (A.W.).'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Harrison', 'Affiliation': 'Vanderbilt University, Nashville, TN (D.G.H.).'}, {'ForeName': 'Tomasz J', 'Initials': 'TJ', 'LastName': 'Guzik', 'Affiliation': 'Institute of Cardiovascular and Medical Research, Queen Elizabeth University Hospital, University of Glasgow (T.J.G.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Libby', 'Affiliation': ""Cardiovascular Division (P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Center for Cardiovascular Disease Prevention (J.M., R.J.G., P.M.R.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Center for Cardiovascular Disease Prevention (J.M., R.J.G., P.M.R.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.13642']
421,32206987,"Effects of Xuezhitong in Patients with Hypertriglyceridemia: a Multicentre, Randomized, Double-Blind, Double Simulation, Positive Drug and Placebo Parallel Control Study.","BACKGROUD
Xuezhitong (XZT) is an extract of Allium macrostemon Bunge that has lipid-lowering properties.
OBJECTIVE
To evaluate the effects of XZT on lipids in subjects with hypertriglyceridemia (HTG) without severe dyslipidaemia.
METHODS
A total of 358 subjects with HTG were enrolled and randomly assigned to receive XZT (2700 mg daily), xuezhikang (XZK) (1200 mg daily) or placebo. The primary endpoint was the reduction or percent reduction in the TG level over 12 weeks of treatment.
RESULTS
At the 12-week follow-up, a reduction in the TG level from baseline was observed in both groups, but the XZT and XZK groups demonstrated a significantly greater reduction than the placebo group (30.77%, 24.02% vs 11.59%, P < 0.0167); 70.54% of subjects in the XZT group and 62.30% of subjects in the XZK group demonstrated reductions in TG levels of at least 20%, compared with 41.67% of the subjects in the placebo group (P < 0.0167). Treatment with XZT capsules also demonstrated superior performance compared with the placebo with respect to the control of lipids (17.97% vs 5.00%), total cholesterol (TC) (14.18% vs 3.89%), low-density lipoprotein cholesterol (LDL-C) (17.98% vs 2.95%), and high-density lipoprotein cholesterol (HDL-C) (21.47% vs 2.16%). Daily use of XZT for 12 weeks resulted in statistically significant (65.22% vs 38.30%, 25.00%; P < 0.0167) and clinically meaningful increases in HDL-C levels by ≥4 mg/dl compared with XZK and placebo. XZT was safe and well tolerated; the safety and tolerability profiles were similar across treatment groups. No subject experienced myopathy or markedly elevated liver transaminases or creatine kinase.
CONCLUSIONS
XZT significantly reduced TG levels and was well tolerated. Longer-term studies in more diverse patient populations are needed to corroborate these findings.
CLINICAL TRIAL REGISTRATION
www.chictr.org.cn Identifier: ChiCTR1900025854.",2020,"At the 12-week follow-up, a reduction in the TG level from baseline was observed in both groups, but the XZT and XZK groups demonstrated a significantly greater reduction than the placebo group (30.77%, 24.02% vs 11.59%, P < 0.0167); 70.54% of subjects in the XZT group and 62.30% of subjects in the XZK group demonstrated reductions in TG levels of at least 20%, compared with 41.67% of the subjects in the placebo group (P < 0.0167).","['subjects with hypertriglyceridemia (HTG) without severe dyslipidaemia', '358 subjects with HTG', 'Patients with Hypertriglyceridemia']","['Xuezhitong (XZT', 'placebo', 'XZK', 'Xuezhitong', 'XZT', 'xuezhikang (XZK', 'XZK and placebo']","['reduction or percent reduction in the TG level', 'tolerated', 'high-density lipoprotein cholesterol (HDL-C', 'safe and well tolerated; the safety and tolerability profiles', 'total cholesterol (TC', 'HDL-C levels', 'TG levels', 'TG level', 'superior performance', 'low-density lipoprotein cholesterol (LDL-C']","[{'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869029', 'cui_str': 'Dyslipidaemia (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1566069', 'cui_str': 'xuezhikang'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",358.0,0.475119,"At the 12-week follow-up, a reduction in the TG level from baseline was observed in both groups, but the XZT and XZK groups demonstrated a significantly greater reduction than the placebo group (30.77%, 24.02% vs 11.59%, P < 0.0167); 70.54% of subjects in the XZT group and 62.30% of subjects in the XZK group demonstrated reductions in TG levels of at least 20%, compared with 41.67% of the subjects in the placebo group (P < 0.0167).","[{'ForeName': 'Wenhao', 'Initials': 'W', 'LastName': 'Jia', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wan', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jinjin', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Technology Center for Drug Research and Evaluation, Chinese Association of Traditional Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zou', 'Affiliation': 'Beijing Compete Pharmaceutical Technology Development Co. LTD, Beijing, China.'}, {'ForeName': 'Junpin', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Harbin kansaisi Pharmaceutical Technology Development co. LTD, Harbin, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China. linqian62@126.com.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-06965-3']
422,31962344,Activation of D1 receptors affects human reactivity and flexibility to valued cues.,"Reward-predicting cues motivate goal-directed behavior, but in unstable environments humans must also be able to flexibly update cue-reward associations. While the capacity of reward cues to trigger motivation ('reactivity') as well as flexibility in cue-reward associations have been linked to the neurotransmitter dopamine in humans, the specific contribution of the dopamine D1 receptor family to these behaviors remained elusive. To fill this gap, we conducted a randomized, placebo-controlled, double-blind pharmacological study testing the impact of three different doses of a novel D1 agonist (relative to placebo) on reactivity to reward-predicting cues (Pavlovian-to-instrumental transfer) and flexibility of cue-outcome associations (reversal learning). We observed that the impact of the D1 agonist crucially depended on baseline working memory functioning, which has been identified as a proxy for baseline dopamine synthesis capacity. Specifically, increasing D1 receptor stimulation strengthened Pavlovian-to-instrumental transfer in individuals with high baseline working memory capacity. In contrast, higher doses of the D1 agonist improved reversal learning only in individuals with low baseline working memory functioning. Our findings suggest a crucial and baseline-dependent role of D1 receptor activation in controlling both cue reactivity and the flexibility of cue-reward associations.",2020,"Specifically, increasing D1 receptor stimulation strengthened Pavlovian-to-instrumental transfer in individuals with high baseline working memory capacity.",[],"['novel D1 agonist (relative to placebo', 'placebo']","['reactivity to reward-predicting cues (Pavlovian-to-instrumental transfer) and flexibility of cue-outcome associations (reversal learning', 'reversal learning']",[],"[{'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.119234,"Specifically, increasing D1 receptor stimulation strengthened Pavlovian-to-instrumental transfer in individuals with high baseline working memory capacity.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Soutschek', 'Affiliation': 'Department of Psychology, Ludwig Maximilian University Munich, Munich, Germany. Alexander.Soutschek@psy.lmu.de.'}, {'ForeName': 'Rouba', 'Initials': 'R', 'LastName': 'Kozak', 'Affiliation': 'Takeda Pharmaceuticals International, Cambridge, MA, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'de Martinis', 'Affiliation': 'Praxis Precision Medicines, Cambridge, MA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Howe', 'Affiliation': 'School of Neuroscience, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Burke', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Fehr', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Jetter', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Philippe N', 'Initials': 'PN', 'LastName': 'Tobler', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0617-z']
423,31560093,Perceptions of Community and Clinic-Based Adherence Clubs for Patients Stable on Antiretroviral Treatment: A Mixed Methods Study.,"Adherence clubs for patients stable on antiretroviral treatment (ART) offer decongestion of clinics and task-shifting, improved adherence and retention in care. Findings on patient acceptability by club location (in the clinic vs. the community) are limited. This was a mixed-methods study set within a randomized controlled trial of community versus clinic-based adherence clubs for retention in care at Witkoppen Health and Welfare Centre in Johannesburg, South Africa. Participants were surveyed on preferences for adherence club-based care (e.g. location, convenience). We conducted in-depth interviews (IDIs) with 36 participants, and surveyed 568 participants: 49% in community-based clubs and 51% in clinic-based clubs. Participants in both arms favorably rated adherence clubs. Almost all (95%) in clinic-based clubs would recommend them to a friend, while fewer (88% in community-based club participants would do so (p = 0.004). Participants found clubs promoted social support, and were convenient and time-saving, though concerns around stigma and access to other health care were noted within community-based clubs. Adherence clubs are a highly acceptable form of differentiated care for stable ART patients. These data indicate that clinic-based clubs may be preferred above community-based clubs, potentially for reasons of stigma and access to additional health care services.",2020,"Participants found clubs promoted social support, and were convenient and time-saving, though concerns around stigma and access to other health care were noted within community-based clubs.","['Participants were surveyed on preferences for adherence club-based care (e.g. location, convenience', '36 participants, and surveyed 568 participants: 49% in community-based clubs and 51% in clinic-based clubs', 'patients stable on antiretroviral treatment (ART', 'community versus clinic-based adherence clubs for retention in care at\xa0Witkoppen Health and Welfare Centre in Johannesburg, South Africa']",[],[],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C4704685', 'cui_str': 'Retention in Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]",[],[],568.0,0.0614369,"Participants found clubs promoted social support, and were convenient and time-saving, though concerns around stigma and access to other health care were noted within community-based clubs.","[{'ForeName': 'Mutsa', 'Initials': 'M', 'LastName': 'Mudavanhu', 'Affiliation': 'Witkoppen Health and Welfare Centre, Fourways, Johannesburg, South Africa.'}, {'ForeName': 'Nora S', 'Initials': 'NS', 'LastName': 'West', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Sheree R', 'Initials': 'SR', 'LastName': 'Schwartz', 'Affiliation': 'Department of Epidemiology, Johns Hopkins School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Mutunga', 'Affiliation': 'Witkoppen Health and Welfare Centre, Fourways, Johannesburg, South Africa.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Keyser', 'Affiliation': 'Witkoppen Health and Welfare Centre, Fourways, Johannesburg, South Africa.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bassett', 'Affiliation': 'Witkoppen Health and Welfare Centre, Fourways, Johannesburg, South Africa.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Van Rie', 'Affiliation': 'Epidemiology for Global Health Institute, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Colleen F', 'Initials': 'CF', 'LastName': 'Hanrahan', 'Affiliation': 'Department of Epidemiology, Johns Hopkins School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA. chanrah1@jhmi.edu.'}]",AIDS and behavior,['10.1007/s10461-019-02681-8']
424,31435774,Gabapentin for the management of chronic pelvic pain in women.,"BACKGROUND
Chronic pelvic pain (CPP) is a frequent presenting symptom in gynaecology outpatient clinics. Neuromodulator pharmacological agents could be an option for treatment based on its efficacy in treating chronic pain in other conditions.
PURPOSE
This study aimed at evaluating the efficacy of oral Gabapentin to alleviate pain in women with CPP.
METHODS
In a randomized double-blinded placebo-controlled trial, 60 women suffering from chronic pelvic pain were randomly divided into two equal arms. The study group received Gabapentin 300 mg three times daily initially (900 mg), with 300 mg weekly incremental dose till pain was controlled, severe side effects occurred or maximum daily dose of 2700 mg was reached. The Primary outcome was the pain score improvement of CPP, defined as a 30% reduction in the pain score assessed by the 10-cm Visual Analogue Scale compared to baseline score.
RESULTS
In Gabapentin group, pain was significantly reduced at 12 and 24 weeks (mean = 5.12 ± 0.67 and 3.72 ± 0.69, respectively) than in placebo group (mean = 5.9 ± 0.92 and 5.5 ± 1.13, respectively); this difference was significant. At 24 weeks, there was significantly higher proportion of patients reporting 30% or more reduction in pain scores; 19 out of 20 patients (95%) in Gabapentin group compared to 8 out of 14 patients (57.1%) in placebo group. The relative risk for pain after gabapentin treatment was 0.5 with 95% confidence interval = 0.34 to 0.75 and number needed to treat = 3 (p = 0.007). Regarding adverse effects there was significantly higher incidence of dizziness with Gabapentin (26.1%) compared to placebo (3.3%).
CONCLUSION
Chronic pelvic pain in women may be treated sufficiently with Gabapentin.
TRIAL REGISTRATION
The trial was registered in ClinicalTrials.gov registry with clinical trial registration number: NCT02918760.",2019,The relative risk for pain after gabapentin treatment was 0.5 with 95% confidence interval = 0.34 to 0.75 and number needed to treat = 3 (p = 0.007).,"['60 women suffering from chronic pelvic pain', 'chronic pelvic pain in women', 'gynaecology outpatient clinics', 'women with CPP']","['placebo', 'Gabapentin']","['Chronic pelvic pain', 'pain', 'relative risk for pain', 'pain score improvement of CPP', 'dizziness', 'pain score assessed by the 10-cm Visual Analogue Scale', 'pain scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0047123', 'cui_str': 'CPP'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0047123', 'cui_str': 'CPP'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",60.0,0.716219,The relative risk for pain after gabapentin treatment was 0.5 with 95% confidence interval = 0.34 to 0.75 and number needed to treat = 3 (p = 0.007).,"[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'AbdelHafeez', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University Hospitals, Maternity Hospital, Ain Shams University, Abbaseya square, Cairo, Egypt.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Reda', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University Hospitals, Maternity Hospital, Ain Shams University, Abbaseya square, Cairo, Egypt. reda.ahmed@yandex.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University Hospitals, Maternity Hospital, Ain Shams University, Abbaseya square, Cairo, Egypt.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'El-Zeneiny', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University Hospitals, Maternity Hospital, Ain Shams University, Abbaseya square, Cairo, Egypt.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Mokhles', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University Hospitals, Maternity Hospital, Ain Shams University, Abbaseya square, Cairo, Egypt.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05272-z']
425,32164544,Experiences of dementia and attitude towards prevention: a qualitative study among older adults participating in a prevention trial.,"BACKGROUND
A better insight into older adults' understanding of and attitude towards cognitive disorders and their prevention, as well as expectations and reasons for participation in prevention trials, would help design, conduct, and implement effective preventive interventions. This qualitative study aimed at exploring the knowledge and perceptions of cognitive disorders and their prevention among participants in a prevention trial.
METHODS
Semi-structured interviews were conducted among the participants of a multinational randomised controlled trial testing the efficacy of a lifestyle-based eHealth intervention in preventing cardiovascular disease or cognitive decline in community dwellers aged 65+. Participants were probed on their reasons for participation in the trial and their views on general health, cardiovascular disease, ageing, and prevention. The subset of data focusing on cognitive disorders (15 interviewees; all in Finland) was considered for this study. Data were analysed using content analysis.
RESULTS
Participants' knowledge of the cause and risk factors of cognitive disorders and prevention was limited and superficial, and a need for up-to-date, reliable, and practical information and advice was expressed. Cognitive disorders evoked fear and concern, and feelings of hopelessness and misery were frequently expressed, indicating a stigma. Strong heredity of cognitive disorders was a commonly held belief, and opinions on the possibility of prevention were doubtful, particularly in relation to primary prevention. Family history and/or indirect experiences of cognitive disorders was a recurrent theme and it showed to be linked to both the knowledge of and feelings associated with cognitive disorders, as well as attitude towards prevention. Indirect experiences were linked to increased awareness and knowledge, but also uncertainty about risk factors and possibility of prevention. Distinct fear and concerns, particularly over one's own cognition/risk, and high motivation towards engaging in prevention and participating in a prevention trial were also identified in connection to this theme.
CONCLUSIONS
Family history and/or indirect experiences of cognitive disorders were linked to sensitivity and receptiveness to brain health and prevention potential. Our findings may be helpful in addressing older adults' expectations in future prevention trials to improve recruitment, maximise adherence, and facilitate the successful implementation of interventions.",2020,"CONCLUSIONS
Family history and/or indirect experiences of cognitive disorders were linked to sensitivity and receptiveness to brain health and prevention potential.","['Semi-structured interviews', 'older adults participating in a prevention trial', 'older adults', 'community dwellers aged 65', 'participants in a prevention trial']",['lifestyle-based eHealth intervention'],"['Cognitive disorders evoked fear and concern, and feelings of hopelessness and misery', 'cardiovascular disease or cognitive decline']","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}]","[{'cui': 'C0009241', 'cui_str': 'Cognition Disorders'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0150041', 'cui_str': 'Feeling of hopelessness'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}]",,0.0213142,"CONCLUSIONS
Family history and/or indirect experiences of cognitive disorders were linked to sensitivity and receptiveness to brain health and prevention potential.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland. anna.rosenberg@uef.fi.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Coley', 'Affiliation': 'LEASP, UMR 1027, INSERM/Université Toulouse III Paul Sabatier, University of Toulouse, Toulouse, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Soulier', 'Affiliation': 'LEASP, UMR 1027, INSERM/Université Toulouse III Paul Sabatier, University of Toulouse, Toulouse, France.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Kulmala', 'Affiliation': 'Public Health Promotion Unit, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Hilkka', 'Initials': 'H', 'LastName': 'Soininen', 'Affiliation': 'Department of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Andrieu', 'Affiliation': 'LEASP, UMR 1027, INSERM/Université Toulouse III Paul Sabatier, University of Toulouse, Toulouse, France.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Kivipelto', 'Affiliation': 'Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mariagnese', 'Initials': 'M', 'LastName': 'Barbera', 'Affiliation': 'Department of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC geriatrics,['10.1186/s12877-020-1493-4']
426,32164587,A cluster randomised trial of the program to enhance adjustment to residential living (PEARL): a novel psychological intervention to reduce depression in newly admitted aged care residents.,"BACKGROUND
Depression rates are high in residential aged care (RAC) facilities, with newly admitted residents at particular risk. New approaches to address depression in this population are urgently required, particularly psychological interventions suitable for widespread use across the RAC sector. The Program to Enhance Adjustment to Residential Living (PEARL) is a brief intervention, designed to provide individually tailored care approaches to meet the psychological needs of newly admitted residents, delivered in collaboration with facility staff.
METHODS
PEARL will be evaluated using a cluster randomised controlled design, comparing outcomes for residents who participate in the intervention with those residing in care as usual control facilities. Participants are RAC residents aged 60 years or above, with normal cognition or mild-moderate cognitive impairment, who relocated to the facility within the previous 4 weeks. The primary outcomes are depressive symptoms and disorders, with secondary outcomes including anxiety, stress, quality of life, adjustment to RAC, and functional dependence, analysed on an intention to treat basis using multilevel modelling.
DISCUSSION
PEARL is an intervention based on self-determination theory, designed to reduce depression in newly admitted residents by tailoring day to day care to meet their psychological needs. This simple psychological approach offers an alternative care model to the current over-reliance of antidepressant medications.
TRIAL REGISTRATION
ACTRN12616001726448; Registered 16 December 2016 with the Australian New Zealand Clinical Trials Registry.",2020,"The Program to Enhance Adjustment to Residential Living (PEARL) is a brief intervention, designed to provide individually tailored care approaches to meet the psychological needs of newly admitted residents, delivered in collaboration with facility staff.
","['residential aged care (RAC) facilities, with newly admitted residents at particular risk', 'Participants are RAC residents aged 60\u2009years or above, with normal cognition or mild-moderate cognitive impairment, who relocated to the facility within the previous 4 weeks', 'residents who participate in the intervention with those residing in care as usual control facilities', '16 December 2016 with the Australian New Zealand Clinical Trials Registry', 'newly admitted aged care residents']","['program to enhance adjustment to residential living (PEARL', 'psychological intervention']","['depressive symptoms and disorders, with secondary outcomes including anxiety, stress, quality of life, adjustment to RAC, and functional dependence, analysed on an intention to treat basis using multilevel modelling']","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2712133', 'cui_str': 'Normal cognition (finding)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C3839816', 'cui_str': 'Moderate cognitive impairment (finding)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0034380'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1626935', 'cui_str': 'Base'}]",,0.0698392,"The Program to Enhance Adjustment to Residential Living (PEARL) is a brief intervention, designed to provide individually tailored care approaches to meet the psychological needs of newly admitted residents, delivered in collaboration with facility staff.
","[{'ForeName': 'Tanya E', 'Initials': 'TE', 'LastName': 'Davison', 'Affiliation': 'Health and Ageing Research Group, School of Health Sciences, Faculty of Health, Arts and Design, Swinburne University of Technology, H95 PO Box 218, Hawthorn, VIC, 3122, Australia. tdavison@swin.edu.au.'}, {'ForeName': 'Marita P', 'Initials': 'MP', 'LastName': 'McCabe', 'Affiliation': 'Health and Ageing Research Group, School of Health Sciences, Faculty of Health, Arts and Design, Swinburne University of Technology, H95 PO Box 218, Hawthorn, VIC, 3122, Australia.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Busija', 'Affiliation': 'Biostatistics Consulting Platform, Research Methodology Division, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventative Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Health and Human Services, Melbourne, VIC, Australia.'}, {'ForeName': 'Vera Camões', 'Initials': 'VC', 'LastName': 'Costa', 'Affiliation': 'Health and Ageing Research Group, School of Health Sciences, Faculty of Health, Arts and Design, Swinburne University of Technology, H95 PO Box 218, Hawthorn, VIC, 3122, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Byers', 'Affiliation': 'Health and Ageing Research Group, School of Health Sciences, Faculty of Health, Arts and Design, Swinburne University of Technology, H95 PO Box 218, Hawthorn, VIC, 3122, Australia.'}]",BMC geriatrics,['10.1186/s12877-020-1492-5']
427,32131865,Mobile phone support to sustain exclusive breastfeeding in the community after hospital delivery and counseling: a quasi-experimental study.,"BACKGROUND
Rapid increases in hospital and cesarean deliveries threaten an already falling exclusive breastfeeding rate (EBR) in Bangladesh. There is neither a sustained Baby-Friendly Hospital Initiative (BFHI) nor any community support for breastfeeding mothers. Our aim was to find out whether breastfeeding support after hospital delivery and subsequently by mobile phone at home is effective in improving EBR in infants under six-months of age.
METHODS
A quasi-experimental study was carried out in 2010 at the Centre for Woman and Child Health (CWCH), Savar, Bangladesh. A total of 129 mothers delivered at CWCH were recruited in pre-intervention phase and their infants followed up between 0 and 5 months of age in the community for exclusive breastfeeding (EBF), anthropometry and illness. An intervention package was then implemented with postpartum support for first hour breastfeeding initiation, correction of position and attachment and face-to-face counseling in hospital followed by mobile phone support by two trained Research Assistants once every 15 days after discharge up to six months of age. During the intervention phase, 164 pregnant women delivered at CWCH were recruited and followed up as in the pre-intervention phase.
RESULTS
In the pre-intervention phase among 114 infants, 66 (58%) were found to be exclusively breastfed. In the intervention phase among 151 infants, 118 (78%) were exclusively breastfed (p = 0.000). In the pre-intervention phase EBR at less than one month and five months were 85 and 42% as in the intervention phase these EBR were 89 and 71% respectively. Wasting (weight-for-height Z-score < - 2.00), stunting (height-for-age Z-score < - 2.00), and underweight (weight-for-age Z-score < - 2.00) was 17 (15%), 7 (6%), and 14 (13%) respectively in the pre-intervention phase. In the intervention phase wasting, stunting, and underweight was 16 (11%), 16 (11%), and 15 (10%) respectively. Therefore, there was no statistically significant differences in nutritional status of the infants in the two phases. There was also no significant differences in child morbidity (pneumonia and diarrhea) between the two phases.
CONCLUSION
A combination of hospital support and mobile phone counseling in the community sustained higher rates of EBF in the community after hospital delivery.",2020,"In the intervention phase among 151 infants, 118 (78%) were exclusively breastfed (p = 0.000).","['A quasi-experimental study was carried out in 2010 at the Centre for Woman and Child Health (CWCH), Savar, Bangladesh', 'Wasting (weight-for-height Z-score\u2009<\u2009-\u20092.00), stunting (height-for-age Z-score\u2009<\u2009-\u20092.00), and underweight', 'infants under six-months of age', 'hospital and cesarean deliveries threaten an already falling exclusive breastfeeding rate (EBR) in Bangladesh', '129 mothers delivered at CWCH\xa0were recruited in pre-intervention phase and their infants\xa0followed up between 0 and 5\u2009months of age in the community for exclusive breastfeeding (EBF), anthropometry and illness', '164 pregnant women\xa0delivered at CWCH were recruited and followed up as in the pre-intervention phase', '114 infants, 66 (58%) were found to be exclusively breastfed']","['Mobile phone support to sustain exclusive breastfeeding', 'hospital support and mobile phone counseling']","['child morbidity (pneumonia and diarrhea', 'wasting, stunting, and underweight', 'sustained Baby-Friendly Hospital Initiative (BFHI', 'nutritional status']","[{'cui': 'C2985410', 'cui_str': 'Clinical Trials, Nonrandomized'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0424670', 'cui_str': 'Weight for height (observable entity)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0566687', 'cui_str': 'Mother delivered (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}]","[{'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}]",164.0,0.0259962,"In the intervention phase among 151 infants, 118 (78%) were exclusively breastfed (p = 0.000).","[{'ForeName': 'Iftia', 'Initials': 'I', 'LastName': 'Jerin', 'Affiliation': 'Centre for Woman and Child Health (CWCH), Savar, Dhaka, 1349, Bangladesh.'}, {'ForeName': 'Monira', 'Initials': 'M', 'LastName': 'Akter', 'Affiliation': 'Centre for Woman and Child Health (CWCH), Savar, Dhaka, 1349, Bangladesh. monira.akter03@yahoo.com.'}, {'ForeName': 'Khurshid', 'Initials': 'K', 'LastName': 'Talukder', 'Affiliation': 'Centre for Woman and Child Health (CWCH), Savar, Dhaka, 1349, Bangladesh.'}, {'ForeName': 'Muhammad Qudrat E Khuda', 'Initials': 'MQEK', 'LastName': 'Talukder', 'Affiliation': 'Centre for Woman and Child Health (CWCH), Savar, Dhaka, 1349, Bangladesh.'}, {'ForeName': 'Mohammad Abdur', 'Initials': 'MA', 'LastName': 'Rahman', 'Affiliation': 'Department of Public Health and Informatics, Jahangirnagar University, Savar, Dhaka, 1342, Bangladesh.'}]",International breastfeeding journal,['10.1186/s13006-020-00258-z']
428,32019428,Sleep for Stroke Management and Recovery Trial (Sleep SMART): Rationale and methods.,"RATIONALE
Obstructive sleep apnea is common among patients with acute ischemic stroke and is associated with reduced functional recovery and an increased risk for recurrent vascular events.
AIMS AND/OR HYPOTHESIS
The Sleep for Stroke Management and Recovery Trial (Sleep SMART) aims to determine whether automatically adjusting continuous positive airway pressure (aCPAP) treatment for obstructive sleep apnea improves clinical outcomes after acute ischemic stroke or high-risk transient ischemic attack.
SAMPLE SIZE ESTIMATE
A total of 3062 randomized subjects for the prevention of recurrent serious vascular events, and among these, 1362 stroke survivors for the recovery outcome.
METHODS AND DESIGN
Sleep SMART is a phase III, multicenter, prospective randomized, open, blinded outcome event assessed controlled trial. Adults with recent acute ischemic stroke/transient ischemic attack and no contraindication to aCPAP are screened for obstructive sleep apnea with a portable sleep apnea test. Subjects with confirmed obstructive sleep apnea but without predominant central sleep apnea proceed to a run-in night of aCPAP. Subjects with use (≥4 h) of aCPAP and without development of significant central apneas are randomized to aCPAP plus usual care or care-as-usual for six months. Telemedicine is used to monitor and facilitate aCPAP adherence remotely.
STUDY OUTCOMES
Two separate primary outcomes: (1) the composite of recurrent acute ischemic stroke, acute coronary syndrome, and all-cause mortality (prevention) and (2) the modified Rankin scale scores (recovery) at six- and three-month post-randomization, respectively.
DISCUSSION
Sleep SMART represents the first large trial to test whether aCPAP for obstructive sleep apnea after stroke/transient ischemic attack reduces recurrent vascular events or death, and improves functional recovery.",2020,Subjects with use (≥4 h) of aCPAP and without development of significant central apneas are randomized to aCPAP plus usual care or care-as-usual for six months.,"['Subjects with use (≥4\u2009h) of aCPAP and without development of significant central apneas', 'Subjects with confirmed obstructive sleep apnea but without predominant central sleep apnea', 'Adults with recent acute ischemic stroke/transient ischemic attack and no contraindication to aCPAP are screened for obstructive sleep apnea with a portable sleep apnea test', '3062 randomized subjects for the prevention of recurrent serious vascular events, and among these, 1362 stroke survivors for the recovery outcome', 'patients with acute ischemic stroke', 'Sleep SMART']","['aCPAP', 'aCPAP plus usual care or care-as-usual for six months', 'Telemedicine', 'automatically adjusting continuous positive airway pressure (aCPAP) treatment']","['obstructive sleep apnea', 'composite of recurrent acute ischemic stroke, acute coronary syndrome, and all-cause mortality (prevention) and (2) the modified Rankin scale scores (recovery']","[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0520680', 'cui_str': 'Ondine Syndrome'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C3887547', 'cui_str': 'Central sleep apnea syndrome (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439589', 'cui_str': 'Recurrent acute (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",3062.0,0.0612725,Subjects with use (≥4 h) of aCPAP and without development of significant central apneas are randomized to aCPAP plus usual care or care-as-usual for six months.,"[{'ForeName': 'Devin L', 'Initials': 'DL', 'LastName': 'Brown', 'Affiliation': 'Division of Vascular Neurology and Division of Sleep Medicine, Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Durkalski', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Durmer', 'Affiliation': 'Nox Health, Johns Creek, GA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Broderick', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, UC Gardner Neuroscience Institute, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Darin B', 'Initials': 'DB', 'LastName': 'Zahuranec', 'Affiliation': 'Division of Vascular Neurology, Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Levine', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'Faculty of Medicine, The George Institute for Global Health, UNSW, Sydney, Australia.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Bravata', 'Affiliation': 'Department of Internal Medicine and Neurology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'H Klar', 'Initials': 'HK', 'LastName': 'Yaggi', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lewis B', 'Initials': 'LB', 'LastName': 'Morgenstern', 'Affiliation': 'Division of Vascular Neurology, Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Claudia S', 'Initials': 'CS', 'LastName': 'Moy', 'Affiliation': 'National Institutes of Neurological Disorders and Stroke, Bethesda, MD, USA.'}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Chervin', 'Affiliation': 'Department of Neurology and Sleep Disorders Center, University of Michigan, Ann Arbor, MI, USA.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020903979']
429,31709823,A Novel School-based Intermittent Delivery System of Iron Supplements for Highly Marginalized Tarahumara Indigenous Women of Reproductive Age of Northern Mexico.,"To develop a novel delivery scheme to bridge the Mexican health system with highly isolated indigenous communities by involving naturally occurring social links: households and boarding schools. This was a school-based placebo-controlled trial with a follow-up period of 16 weeks. Children whose mothers fulfilled the inclusion criteria for anemia acted as iron supplement carriers between schools and homes. Adherence was measured based on teachers' and mothers' records. An effectiveness sub-analysis assessed changes in biochemical profiles according to random allocation to either supplementation or placebo groups. There was an overall high adherence in both groups. Analyses revealed that schooling years, literacy, and walking times played a role in high adherence. Logistic regression showed that women had higher adherence odds on the basis of household size, walking times, and previous inclusion in supplement distributions. Adherence significantly decreased the proportion of anemia by 48.2% in the intervention group. The difference at baseline and endpoint significantly reduced the number of iron-deficient anemic women by 67.7% in the supplementation group. This delivery method is a valid alternative to the conventional efforts used to reach Tarahumara indigenous communities, and could also have the potential to be piloted to tackle other health issues hindering these marginalized communities.",2020,To develop a novel delivery scheme to bridge the Mexican health system with highly isolated indigenous communities by involving naturally occurring social links: households and boarding schools.,"['Mexican health system with highly isolated indigenous communities by involving naturally occurring social links: households and boarding schools', 'Children whose mothers fulfilled the inclusion criteria for anemia acted as iron supplement carriers between schools and homes', 'Highly Marginalized Tarahumara', 'Indigenous Women of Reproductive Age of Northern Mexico']",['placebo'],"['Adherence', 'proportion of anemia', 'number of iron-deficient anemic']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0424935', 'cui_str': 'Boarding school (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0721124', 'cui_str': 'Iron supplement (substance)'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}]",,0.0537009,To develop a novel delivery scheme to bridge the Mexican health system with highly isolated indigenous communities by involving naturally occurring social links: households and boarding schools.,"[{'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Crispino', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Monárrez-Espino', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}]",Ecology of food and nutrition,['10.1080/03670244.2019.1689493']
430,31735108,"Effects of Venous Angioplasty on Cerebral Lesions in Multiple Sclerosis: Expanded Analysis of the Brave Dreams Double-Blind, Sham-Controlled Randomized Trial.","PURPOSE
To evaluate if jugular vein flow restoration in various venographic defects indicative of chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis (MS) patients can have positive effects on cerebral lesions identified using magnetic resonance imaging (MRI).
MATERIALS AND METHODS
The Brave Dreams trial ( ClinicalTrials.gov identifier NCT01371760) was a multicenter, randomized, parallel group, double-blind, sham-controlled trial to assess the efficacy of jugular venoplasty in MS patients with CCSVI. Between August 2012 and March 2016, 130 patients (mean age 39.9±10.6 years; 81 women) with relapsing/remitting (n=115) or secondary/progressive (n=15) MS were randomized 2:1 to venography plus angioplasty (n=86) or venography (sham; n=44). Patients and study personnel (except the interventionist) were masked to treatment assignment. MRI data acquired at 6 and 12 months after randomization were compared to the preoperative scan for new and/or >30% enlargement of T2 lesions plus new gadolinium enhancement of pre-existing lesions. The relative risks (RR) with 95% confidence interval (CI) were estimated and compared. In a secondary assessment, venograms of patients who underwent venous angioplasty were graded as ""favorable"" (n=38) or ""unfavorable"" (n=30) for dilation according to the Giaquinta grading system by 4 investigators blinded to outcomes. These subgroups were also compared.
RESULTS
Of the 130 patients enrolled, 125 (96%) completed the 12-month MRI follow-up. Analysis showed that the likelihood of being free of new cerebral lesions at 1 year was significantly higher after venoplasty compared to the sham group (RR 1.42, 95% CI 1.00 to 2.01, p=0.032). Patients with favorable venograms had a significantly higher probability of being free of new cerebral lesions than patients with unfavorable venograms (RR 1.82, 95% CI 1.17 to 2.83, p=0.005) or patients in the sham arm (RR 1.66, 95% CI 1.16 to 2.37, p=0.005).
CONCLUSION
Expanded analysis of the Brave Dreams data that included secondary/progressive MS patients in addition to the relapsing/remitting patients analyzed previously showed that venoplasty decreases new cerebral lesions at 1 year. Secondary analysis confirmed the efficacy of the Giaquinta grading system in selecting patients appropriate for venoplasty who were more likely to be free from accumulation of new cerebral lesions at MRI.",2020,"Patients with favorable venograms had a significantly higher probability of being free of new cerebral lesions than patients with unfavorable venograms (RR 1.82, 95% CI 1.17 to 2.83, p=0.005) or patients in the sham arm (RR 1.66,","['chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis (MS) patients', 'Between August 2012 and March 2016, 130 patients (mean age 39.9±10.6 years; 81 women) with relapsing/remitting (n=115) or secondary/progressive (n=15) MS', 'MS patients with CCSVI', 'Multiple Sclerosis', '130 patients enrolled, 125 (96%) completed the 12-month MRI follow-up']","['unfavorable', 'Venous Angioplasty', 'jugular vein flow restoration', 'magnetic resonance imaging (MRI', 'venography plus angioplasty (n=86) or venography']","['Cerebral Lesions', 'efficacy of jugular venoplasty', 'relative risks (RR', 'probability of being free of new cerebral lesions', 'likelihood of being free of new cerebral lesions']","[{'cui': 'C4511608', 'cui_str': 'CCSVI - chronic cerebrospinal venous insufficiency'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0455750', 'cui_str': 'Angioplasty of vein (procedure)'}, {'cui': 'C0022427', 'cui_str': 'Jugular Veins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0031545', 'cui_str': 'Venography'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]",81.0,0.298585,"Patients with favorable venograms had a significantly higher probability of being free of new cerebral lesions than patients with unfavorable venograms (RR 1.82, 95% CI 1.17 to 2.83, p=0.005) or patients in the sham arm (RR 1.66,","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zamboni', 'Affiliation': 'HUB Center for Venous and Lymphatics Disorders of the Emilia Romagna Region, S. Anna University Hospital, Ferrara, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Galeotti', 'Affiliation': 'Unit of Interventional Radiology, S. Anna University Hospital, Ferrara, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Salvi', 'Affiliation': 'IRCCS of the Neurosciences, Bellaria Hospital, Bologna, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Giaquinta', 'Affiliation': 'Unit of Vascular Surgery and Transplantation, University of Catania, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Setacci', 'Affiliation': 'Unit of Vascular Surgery, University of Siena, Siena, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Alborino', 'Affiliation': 'Unit of Radiology, Macerata Hospital, ASUR Marche, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Guzzardi', 'Affiliation': 'Unit of Interventional Radiology, Ospedale Maggiore, Novara, Italy.'}, {'ForeName': 'Salvatore J', 'Initials': 'SJ', 'LastName': 'Sclafani', 'Affiliation': 'Department of Radiology, New York State University in Brooklyn, New York, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Maietti', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, University of Bologna Center for Clinical Epidemiology, School of Medicine, University of Ferrara, Italy.'}, {'ForeName': 'Pierfrancesco', 'Initials': 'P', 'LastName': 'Veroux', 'Affiliation': 'Unit of Vascular Surgery and Transplantation, University of Catania, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602819890110']
431,31896118,"Effects of intranasal insulin as an enhancer of fear extinction: a randomized, double-blind, placebo-controlled experimental study.","Fear-extinction based psychotherapy (exposure) is the most effective method for treating anxiety disorders. Notwithstanding, since some patients show impairments in the unlearning of fear and insufficient fear remission, there is a growing interest in using cognitive enhancers as adjuvants to exposure. As insulin plays a critical role in stress processes and acts as a memory enhancer, this study aimed to assess the capacity of intranasal insulin to augment fear extinction. A double-blind, placebo-controlled differential fear-conditioning paradigm was conducted in 123 healthy participants (63 females). Pictures of faces with neutral expressions were used as conditioned stimuli and electric shocks as unconditioned stimuli. The paradigm consisted of four phases presented on three consecutive days: acquisition (day 1), extinction (day 2), reinstatement and re-extinction (day 3). A single intranasal dose of insulin (160 IU) or placebo was applied on day 2, 45 min before fear extinction. Skin conductance response (SCR), fear-potentiated startle (FPS) and expectancy ratings were assessed. During extinction, the insulin group (independent of sex) showed a significantly stronger decrease in differential FPS in comparison with the placebo group. Furthermore, a sex-specific effect was found for SCR, with women in the insulin group showing a greater decrease of differential SCR both at early extinction and at late re-extinction. Our results provide first evidence that intranasal insulin facilitates fear extinction processes and is therefore a promising adjuvant for extinction-based therapies in anxiety and related disorders. Sex-specific effects should be taken into consideration in future studies.",2020,"During extinction, the insulin group (independent of sex) showed a significantly stronger decrease in differential FPS in comparison with the placebo group.",['123 healthy participants (63 females'],"['placebo-controlled differential fear-conditioning paradigm', 'insulin', 'intranasal insulin', 'Fear-extinction based psychotherapy (exposure', 'placebo']","['differential FPS', 'Skin conductance response (SCR), fear-potentiated startle (FPS) and expectancy ratings', 'enhancer of fear extinction', 'differential SCR']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]",123.0,0.138692,"During extinction, the insulin group (independent of sex) showed a significantly stronger decrease in differential FPS in comparison with the placebo group.","[{'ForeName': 'Diana S', 'Initials': 'DS', 'LastName': 'Ferreira de Sá', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany. diana.ferreira@uni-saarland.de.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Römer', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Alexandra H', 'Initials': 'AH', 'LastName': 'Brückner', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Issler', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hauck', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Michael', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0593-3']
432,32131748,Walking barefoot vs. with minimalist footwear - influence on gait in younger and older adults.,"BACKGROUND
In recent years, minimalist footwear has been increasingly promoted for its use in sportive and recreational activities. These shoes are considered to function naturally like barefoot walking while providing a protective surface. Despite a growing popularity of these shoes in the older population, little is known about the influence of minimalist footwear on gait patterns. This study investigated whether overground walking with minimalist shoes is comparable to barefoot walking regarding gait stability and variability parameters.
METHODS
In a randomized within-subject study design, 31 healthy younger (29 ± 4 years) and 33 healthy community-dwelling older adults (71 ± 4 years) volunteered. Participants walked on flat ground, once barefoot and once with minimalist shoes. Gait variability of minimum toe clearance (MTC), stride length, stride time, and local dynamic gait stability were analysed.
RESULTS
The results for both age groups showed significant condition effects (minimalist shoes vs. barefoot walking) for the outcomes of local dynamic stability (p = .013), MTC variability (p = .018), and stride length variability (p < .001) indicating increased local dynamic stability and decreased gait variability during the minimalist shoe condition. Group effects (young vs. older adults) were detected in all gait outcomes.
CONCLUSION
Walking with minimalist shoes appeared to be associated with better gait performance than walking barefoot in both age groups. Thus, walking with minimalist shoes is not similar to barefoot walking. With respect to reducing the risk of falling, we suggest that minimalist shoes could be an alternative to barefoot walking or a transition option between shoes to barefoot for older adults.",2020,"CONCLUSION
Walking with minimalist shoes appeared to be associated with better gait performance than walking barefoot in both age groups.","['31 healthy younger (29\u2009±\u20094\u2009years) and 33 healthy community-dwelling older adults (71\u2009±\u20094\u2009years) volunteered', 'younger and older adults']","['overground walking with minimalist shoes', 'Walking with minimalist shoes', 'Walking barefoot vs. with minimalist footwear - influence']","['MTC variability', 'Gait variability of minimum toe clearance (MTC), stride length, stride time, and local dynamic gait stability', 'stride length variability', 'gait performance', 'gait variability', 'local dynamic stability']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0185506', 'cui_str': 'Shoeing'}, {'cui': 'C0277844', 'cui_str': 'Barefoot walking (finding)'}, {'cui': 'C0336894', 'cui_str': 'Footwear (physical object)'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0040357', 'cui_str': 'Toes'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}]",31.0,0.0307032,"CONCLUSION
Walking with minimalist shoes appeared to be associated with better gait performance than walking barefoot in both age groups.","[{'ForeName': 'Evi', 'Initials': 'E', 'LastName': 'Petersen', 'Affiliation': 'Institute of Sports, Physical Education and Outdoor Life, University of South-Eastern Norway, Bø and Telemark, Norway. evi.petersen@usn.no.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Zech', 'Affiliation': 'Institute of Sports Science, Friedrich-Schiller University of Jena, Jena, Thuringia, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hamacher', 'Affiliation': 'Institute of Sports Science, Friedrich-Schiller University of Jena, Jena, Thuringia, Germany.'}]",BMC geriatrics,['10.1186/s12877-020-1486-3']
433,31785588,Increased subjective and reinforcing effects of initial nicotine exposure in young adults with attention deficit hyperactivity disorder (ADHD) compared to matched peers: results from an experimental model of first-time tobacco use.,"Individuals with attention deficit hyperactivity disorder (ADHD) are at increased risk for adverse cigarette smoking outcomes, and little is known about factors underlying this risk. This study sought to evaluate the effects of initial nicotine exposure in young adults with and without ADHD using a novel paradigm of exposure to model initial smoking experiences. Participants were young adult nonsmokers (n = 61 ADHD, n = 75 Control) between the ages of 18-25 years (inclusive) who reported never having smoked a full cigarette, and no tobacco use in the prior 3 years. Participants were exposed to three different blinded doses of intranasally administered nicotine (0, 0.5, 1.0 mg) across three separate fixed dose experimental sessions. In subsequent sessions, participants were given the opportunity to self-administer nicotine under two different conditions-high and low cognitive demand. Physiological, subjective, and reinforcing effects of nicotine were the main outcomes. Nicotine plasma levels, and no group differences in effects of nicotine on heart rate or blood pressure, confirmed comparable dosing exposure across groups. ADHD participants reported significantly greater dizziness following nicotine, and greater pleasant subjective effects across all conditions, compared to non-ADHD non-smokers. There were no group differences on subjective reports of bad or unpleasant effects. Subsequent nicotine self-administration was significantly higher among non-smokers with ADHD, and their choices of nicotine were not influenced by cognitive condition. There are meaningful differences between young adults with and without ADHD with respect to the initial subjective and reinforcing effects of nicotine; and interventions to prevent use should start prior to typical age of experimentation among ADHD patients.",2020,"Nicotine plasma levels, and no group differences in effects of nicotine on heart rate or blood pressure, confirmed comparable dosing exposure across groups.","['young adults with attention deficit hyperactivity disorder (ADHD', 'Participants were young adult nonsmokers (n\u2009=\u200961 ADHD, n\u2009=\u200975 Control) between the ages of 18-25 years (inclusive) who reported never having smoked a full cigarette, and no tobacco use in the prior 3 years', 'Individuals with attention deficit hyperactivity disorder (ADHD', 'young adults with and without ADHD using a novel paradigm of exposure to model initial smoking experiences']","['initial nicotine exposure', 'nicotine']","['Nicotine plasma levels', 'subjective reports of bad or unpleasant effects', 'pleasant subjective effects', 'dizziness', 'heart rate or blood pressure']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",61.0,0.016876,"Nicotine plasma levels, and no group differences in effects of nicotine on heart rate or blood pressure, confirmed comparable dosing exposure across groups.","[{'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Kollins', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA. scott.kollins@duke.edu.'}, {'ForeName': 'Maggie M', 'Initials': 'MM', 'LastName': 'Sweitzer', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'F Joseph', 'Initials': 'FJ', 'LastName': 'McClernon', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Perkins', 'Affiliation': 'Departments of Psychiatry, Psychology, and Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0581-7']
434,32184050,Tracking the Nonenrolled: Lung Cancer Screening Patterns Among Individuals not Accrued to a Clinical Trial.,"INTRODUCTION
For lung cancer screening, the available data are often derived from patients enrolled prospectively in clinical trials. We, therefore, investigated lung cancer screening patterns among individuals eligible for, but not enrolled in, a screening trial.
PATIENTS AND METHODS
From February 2017 through February 2019, we enrolled subjects in a trial examining telephone-based navigation during low-dose computed tomography (LDCT) for lung cancer screening. We identified patients for whom LDCT was ordered and who were approached, but not enrolled, in the trial. We categorized nonenrollment as the patient had declined or could not be reached. We compared the characteristics and LDCT completion rates among these groups and the enrolled population using the 2-sample t test and χ 2 test.
RESULTS
Of 900 individuals approached for participation (mean age, 62 years; 45% women, 53% black), 447 were enrolled in the screening clinical trial. No significant demographic differences were found between the enrolled and nonenrolled cohorts. Of the 453 individuals not enrolled, 251 (55%) had declined participation and 202 (45%) could not be reached, despite up to 6 attempts. LDCT completion was significantly associated with enrollment status: 81% of enrolled individuals, 73% of individuals who declined participation, and 49% of those who could not be reached (P < .001).
CONCLUSIONS
In the present single-center study, demographic factors did not predict for participation in a lung cancer screening trial. Lung cancer screening adherence rates were substantially lower for those not enrolled in a screening trial, especially for those who could not be contacted. These findings may inform the broader implementation of screening programs.",2020,"LDCT completion was significantly associated with enrollment status: 81% of enrolled individuals, 73% of individuals who declined participation, and 49% of those who could not be reached (P ","['900 individuals approached for participation (mean age, 62 years; 45% women, 53% black), 447 were enrolled in the screening clinical trial', '453 individuals not enrolled, 251 (55%) had declined participation and 202 (45%) could not be reached, despite\xa0up to 6 attempts', 'lung cancer screening patterns among individuals eligible for, but not enrolled in, a screening trial', 'From February 2017 through February 2019', 'Individuals']",['telephone-based navigation during low-dose computed tomography (LDCT'],"['characteristics and LDCT completion rates', 'Lung cancer screening adherence rates', 'LDCT completion']","[{'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}]",447.0,0.104894,"LDCT completion was significantly associated with enrollment status: 81% of enrolled individuals, 73% of individuals who declined participation, and 49% of those who could not be reached (P ","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX; Division of Hematology-Oncology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX; Division of Hematology-Oncology, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX. Electronic address: david.gerber@utsouthwestern.edu.'}, {'ForeName': 'Heidi A', 'Initials': 'HA', 'LastName': 'Hamann', 'Affiliation': 'Department of Psychology, University of Arizona, Tucson, AZ; Department of Family and Community Medicine, University of Arizona, Tucson, AZ.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Chavez', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Dorsey', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Noel O', 'Initials': 'NO', 'LastName': 'Santini', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Browning', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX; Department of Radiology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Cristhiaan D', 'Initials': 'CD', 'LastName': 'Ochoa', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX; Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Adesina', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX.'}, {'ForeName': 'Vijaya Subbu', 'Initials': 'VS', 'LastName': 'Natchimuthu', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Steen', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX; Division of General Internal Medicine, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX; Division of Hematology-Oncology, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Simon J Craddock', 'Initials': 'SJC', 'LastName': 'Lee', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX; Division of Hematology-Oncology, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.02.010']
435,31995811,Nicotine dependence (trait) and acute nicotinic stimulation (state) modulate attention but not inhibitory control: converging fMRI evidence from Go-Nogo and Flanker tasks.,"Cognitive deficits during nicotine withdrawal may contribute to smoking relapse. However, interacting effects of chronic nicotine dependence and acute nicotine withdrawal on cognitive control are poorly understood. Here we examine the effects of nicotine dependence (trait; smokers (n = 24) vs. non-smoking controls; n = 20) and acute nicotinic stimulation (state; administration of nicotine and varenicline, two FDA-approved smoking cessation aids, during abstinence), on two well-established tests of inhibitory control, the Go-Nogo task and the Flanker task, during fMRI scanning. We compared performance and neural responses between these four pharmacological manipulations in a double-blind, placebo-controlled crossover design. As expected, performance in both tasks was modulated by nicotine dependence, abstinence, and pharmacological manipulation. However, effects were driven entirely by conditions that required less inhibitory control. When demand for inhibitory control was high, abstinent smokers showed no deficits. By contrast, acutely abstinent smokers showed performance deficits in easier conditions and missed more trials. Go-Nogo fMRI results showed decreased inhibition-related neural activity in right anterior insula and right putamen in smokers and decreased dorsal anterior cingulate cortex activity on nicotine across groups. No effects were found on inhibition-related activity during the Flanker task or on error-related activity in either task. Given robust nicotinic effects on physiology and behavioral deficits in attention, we are confident that pharmacological manipulations were effective. Thus findings fit a recent proposal that abstinent smokers show decreased ability to divert cognitive resources at low or intermediate cognitive demand, while performance at high cognitive demand remains relatively unaffected, suggesting a primary attentional deficit during acute abstinence.",2020,No effects were found on inhibition-related activity during the Flanker task or on error-related activity in either task.,['trait; smokers (n\u2009=\u200924) vs. non-smoking controls; n\u2009=\u200920) and acute nicotinic stimulation (state; administration of'],"['nicotine and varenicline, two FDA-approved smoking cessation aids, during abstinence), on two well-established tests of inhibitory control, the Go-Nogo task and the Flanker task, during fMRI scanning', 'nicotine dependence', 'placebo', 'Nicotine dependence (trait) and acute nicotinic stimulation (state']","['dorsal anterior cingulate cortex activity', 'inhibition-related neural activity', 'performance deficits', 'Cognitive deficits', 'inhibition-related activity']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]",,0.0240423,No effects were found on inhibition-related activity during the Flanker task or on error-related activity in either task.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lesage', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Sutherland', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Ross', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Salmeron', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Stein', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA. Estein@nih.gov.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0623-1']
436,32187680,Optimizing the design of invasive placebo interventions in randomized controlled trials.,"BACKGROUND
Placebo-controlled trials play an important role in the evaluation of healthcare interventions. However, they can be challenging to design and deliver for invasive interventions, including surgery. In-depth understanding of the component parts of the treatment intervention is needed to ascertain what should, and should not, be delivered as part of the placebo. Assessment of risk to patients and strategies to ensure that the placebo effectively mimics the treatment are also required. To date, no guidance exists for the design of invasive placebo interventions. This study aimed to develop a framework to optimize the design and delivery of invasive placebo interventions in RCTs.
METHODS
A preliminary framework was developed using published literature to: expand the scope of an existing typology, which facilitates the deconstruction of invasive interventions; and identify placebo optimization strategies. The framework was refined after consultation with key stakeholders in surgical trials, consensus methodology and medical ethics.
RESULTS
The resulting DITTO framework consists of five stages: deconstruct treatment intervention into constituent components and co-interventions; identify critical surgical element(s); take out the critical element(s); think risk, feasibility and role of placebo in the trial when considering remaining components; and optimize placebo to ensure effective blinding of patients and trial personnel.
CONCLUSION
DITTO considers invasive placebo composition systematically, accounting for risk, feasibility and placebo optimization. Use of the framework can support the design of high-quality RCTs, which are needed to underpin delivery of healthcare interventions.",2020,"Use of the framework can support the design of high-quality RCTs, which are needed to underpin delivery of healthcare interventions.",[],"['Placebo', 'placebo']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.249571,"Use of the framework can support the design of high-quality RCTs, which are needed to underpin delivery of healthcare interventions.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cousins', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and University of Bristol, Surgical Innovation Theme.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Blencowe', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and University of Bristol, Surgical Innovation Theme.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tsang', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and University of Bristol, Surgical Innovation Theme.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Chalmers', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and University of Bristol, Surgical Innovation Theme.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mardanpour', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and University of Bristol, Surgical Innovation Theme.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Carr', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, NIHR Biomedical Research Centre, University of Oxford.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Campbell', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Cook', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, NIHR Biomedical Research Centre, University of Oxford.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Beard', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, NIHR Biomedical Research Centre, University of Oxford.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Blazeby', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and University of Bristol, Surgical Innovation Theme.'}]",The British journal of surgery,['10.1002/bjs.11509']
437,31128924,"Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial.","BACKGROUND
Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial haemorrhage. Patients surviving the commonest subtype of intracranial haemorrhage, intracerebral haemorrhage, are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear. We aimed to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral haemorrhage and whether this risk might exceed any reduction of occlusive vascular events.
METHODS
The REstart or STop Antithrombotics Randomised Trial (RESTART) was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. We followed participants for the primary outcome (recurrent symptomatic intracerebral haemorrhage) for up to 5 years. We analysed data from all randomised participants using Cox proportional hazards regression, adjusted for minimisation covariates. This trial is registered with ISRCTN (number ISRCTN71907627).
FINDINGS
Between May 22, 2013, and May 31, 2018, 537 participants were recruited a median of 76 days (IQR 29-146) after intracerebral haemorrhage onset: 268 were assigned to start and 269 (one withdrew) to avoid antiplatelet therapy. Participants were followed for a median of 2·0 years (IQR [1·0- 3·0]; completeness 99·3%). 12 (4%) of 268 participants allocated to antiplatelet therapy had recurrence of intracerebral haemorrhage compared with 23 (9%) of 268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51 [95% CI 0·25-1·03]; p=0·060). 18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39-1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02 [0·65-1·60]; p=0·92).
INTERPRETATION
These results exclude all but a very modest increase in the risk of recurrent intracerebral haemorrhage with antiplatelet therapy for patients on antithrombotic therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage. The risk of recurrent intracerebral haemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention.
FUNDING
British Heart Foundation.",2019,"18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39-1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02","['Between May 22, 2013, and May 31, 2018', '122 hospitals in the UK', 'people with occlusive vascular disease', '537 participants were recruited a median of 76 days (IQR 29-146) after intracerebral haemorrhage onset: 268 were assigned to start and 269 (one withdrew) to', 'recruited adults (≥18 years) who were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to', '268 participants allocated to', '268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51', 'after stroke due to intracerebral haemorrhage (RESTART']","['avoid antiplatelet therapy (1·02', 'antithrombotic therapy', 'start or avoid antiplatelet therapy', 'antiplatelet therapy', 'avoid antiplatelet therapy']","['symptomatic intracerebral haemorrhage', 'major occlusive vascular events', 'major haemorrhagic events', 'recurrence of intracerebral haemorrhage', 'risk of recurrent intracerebral haemorrhage']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]","[{'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272689', 'cui_str': 'Started'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]",537.0,0.22394,"18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39-1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)30840-2']
438,32081656,Sleeping with Elevated Upper Body Does Not Attenuate Acute Mountain Sickness: Pragmatic Randomized Clinical Trial.,"PURPOSE
Acute mountain sickness commonly occurs following ascent to high altitude and is aggravated following sleep. Cephalad fluid shifts have been implicated. We hypothesized that sleeping with the upper body elevated by 30º reduces the risk of acute mountain sickness.
METHODS
In a pragmatic, randomized, observer-blinded field study at 4554 meters altitude, we investigated 134 adults aged 18-70 years with a Lake Louise score between 3 and 12 points on the evening of their arrival at the altitude. The individuals were exposed to sleeping on an inflatable cushion elevating the upper body by 30º or on a sham pillow in a horizontal position. The primary endpoint was the change in the Acute Mountain Sickness-Cerebral (AMS-C) score in the morning after sleeping at an altitude of 4554 meters compared with the evening before. Sleep efficiency was the secondary endpoint.
RESULTS
Among 219 eligible mountaineers, 134 fulfilled the inclusion criteria and were randomized. The AMS-C score increased by 0.250 ± 0.575 in the control group and by 0.121 ± 0.679 in the intervention group (difference 0.105; 95% confidence interval, -0.098-0.308; P = .308). Oxygen saturation in the morning was 79% ± 6% in the intervention group and 78% ± 6% in the control group (P = .863). Sleep efficiency did not differ between groups (P = .115).
CONCLUSIONS
Sleeping with the upper body elevated by 30° does not lead to relevant reductions in acute mountain sickness symptoms or hypoxemia at high altitude.",2020,Oxygen saturation in the morning was 79±6 % in the intervention group and 78±6 % in the control group (p=0.863).,"['134 adults aged 18-70 years with a Lake Louise score (LLS) between 3 and 12 points at the evening of their arrival at the altitude', '134 fulfilled the inclusion criteria and were randomized', '219 eligible mountaineers']",['inflatable cushion elevating the upper body by 30° or on a sham pillow in a horizontal position'],"['change in the Acute Mountain Sickness-Cerebral (AMS-C) score', 'risk of acute mountain sickness', 'Oxygen saturation', 'AMS-C score', 'Sleep efficiency']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337049', 'cui_str': 'Lakes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0026623', 'cui_str': 'Mountaineerings'}]","[{'cui': 'C0180249', 'cui_str': 'Cushion'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0182291', 'cui_str': 'Pillow, device (physical object)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",134.0,0.103919,Oxygen saturation in the morning was 79±6 % in the intervention group and 78±6 % in the control group (p=0.863).,"[{'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Limper', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Merheim Medical Center, Hospitals of Cologne, University of Witten/Herdecke, Cologne, Germany; German Aerospace Center (DLR), Institute of Aerospace Medicine, Cologne, Germany.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Fiala', 'Affiliation': 'Department of Anesthesiology, Medical Faculty, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Tank', 'Affiliation': 'German Aerospace Center (DLR), Institute of Aerospace Medicine, Cologne, Germany.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Elmenhorst', 'Affiliation': 'German Aerospace Center (DLR), Institute of Aerospace Medicine, Cologne, Germany; Institute for Occupational, Social and Environmental Medicine, Medical Faculty, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Gereon', 'Initials': 'G', 'LastName': 'Schaelte', 'Affiliation': 'Department of Anesthesiology, Medical Faculty, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Ya-Yu Monica', 'Initials': 'YM', 'LastName': 'Hew', 'Affiliation': 'German Aerospace Center (DLR), Institute of Aerospace Medicine, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gauger', 'Affiliation': 'German Aerospace Center (DLR), Institute of Aerospace Medicine, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': 'Institute of Medical Biometry, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'German Aerospace Center (DLR), Institute of Aerospace Medicine, Cologne, Germany; Chair of Aerospace Medicine, Medical Faculty, University of Cologne, Cologne, Germany. Electronic address: jens.jordan@dlr.de.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.01.024']
439,32016407,How the presentation of patient information and decision-support advisories influences opioid prescribing behavior: A simulation study.,"OBJECTIVE
The United States faces an opioid crisis. Integrating prescription drug monitoring programs into electronic health records offers promise to improve opioid prescribing practices. This study aimed to evaluate 2 different user interface designs for prescription drug monitoring program and electronic health record integration.
MATERIALS AND METHODS
Twenty-four resident physicians participated in a randomized controlled experiment using 4 simulated patient cases. In the conventional condition, prescription opioid histories were presented in tabular format, and computerized clinical decision support (CDS) was provided via interruptive modal dialogs (ie, pop-ups). The alternative condition featured a graphical opioid history, a cue to visit that history, and noninterruptive CDS. Two attending pain specialists judged prescription appropriateness.
RESULTS
Participants in the alternative condition wrote more appropriate prescriptions. When asked after the experiment, most participants stated that they preferred the alternative design to the conventional design.
CONCLUSIONS
How patient information and CDS are presented appears to have a significant influence on opioid prescribing behavior.",2020,"RESULTS
Participants in the alternative condition wrote more appropriate prescriptions.","['Participants in the alternative condition wrote more appropriate prescriptions', 'Twenty-four resident physicians participated']",[],[],"[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C1320928', 'cui_str': 'Resident physician (occupation)'}]",[],[],24.0,0.0260701,"RESULTS
Participants in the alternative condition wrote more appropriate prescriptions.","[{'ForeName': 'Mustafa I', 'Initials': 'MI', 'LastName': 'Hussain', 'Affiliation': 'Department of Informatics, University of California, Irvine, Irvine, California, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Nelson', 'Affiliation': 'Department of Anesthesiology and Perioperative Care, School of Medicine, University of California, Irvine, Irvine, California, USA.'}, {'ForeName': 'Brent G', 'Initials': 'BG', 'LastName': 'Yeung', 'Affiliation': 'Department of Anesthesiology and Perioperative Care, School of Medicine, University of California, Irvine, Irvine, California, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Sukumar', 'Affiliation': 'Departments of Computer Science and Information Systems and Decision Sciences, California State University, Fullerton, Fullerton, California, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zheng', 'Affiliation': 'Department of Informatics, University of California, Irvine, Irvine, California, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz213']
440,32184007,Effect of pectoral nerve block type II under general anesthesia on the immune function of patients with breast cancer.,"BACKGROUND
To investigate whether the use of Pecs II block benefit patients with the respect to the immune functions.
METHODS
Totally 196 patients were included in this study. These patients were randomized to two groups, general anesthesia alone group (G group) and Pectoral nerve (Pecs) II block under general anesthesia group (PG group).
RESULTS
It was found that remifentanil consumption was less in PG group than it in G group. PG group showed a higher proportion of NK cells in peripheral blood mononuclear cell (PBMC) and an improved killing activity than G groups after surgery. We also found that postoperative interleukin (IL)-2 concentration in the plasma of PG group was dramatically higher than it of G group. Interestingly, there was even no significant change between preoperative and postoperative IL-2 levels in PG group, suggesting the less inhibitory effect of Pecs II block on immune system of those patients.
CONCLUSIONS
In conclusion, these results indicate that Pecs II block use in patients may have an enhanced immunity compared with general anesthesia method.",2020,PG group showed a higher proportion of NK cells in peripheral blood mononuclear cell (PBMC) and an improved killing activity than G groups after surgery.,"['Totally 196 patients were included in this study', 'patients with breast cancer']","['general anesthesia alone group (G group) and Pectoral nerve (Pecs) II block under general anesthesia group (PG group', 'pectoral nerve block type II under general anesthesia']","['postoperative interleukin (IL)-2 concentration', 'killing activity', 'preoperative and postoperative IL-2 levels', 'remifentanil consumption', 'NK cells in peripheral blood mononuclear cell (PBMC']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4521763', 'cui_str': 'Killed'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}]",196.0,0.0265303,PG group showed a higher proportion of NK cells in peripheral blood mononuclear cell (PBMC) and an improved killing activity than G groups after surgery.,"[{'ForeName': 'Xiuling', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Department of Anesthesiology, Cangzhou Central Hospital, No 16 Xinhua Road, Cangzhou, 061000, Hebei, China. Electronic address: zhangbo19970418@163.com.'}, {'ForeName': 'Cuinv', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Cangzhou Hospital of Integrated TCM-WM·Hebei, No 31 Huanghe Road, Cangzhou, 061000, Hebei, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Cangzhou Central Hospital, No 16 Xinhua Road, Cangzhou, 061000, Hebei, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Qu', 'Affiliation': 'Department of Anesthesiology, Cangzhou Central Hospital, No 16 Xinhua Road, Cangzhou, 061000, Hebei, China.'}, {'ForeName': 'Bowei', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Hubei Medical College, Shiyan, 442000, Hubei, China.'}, {'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Quality Control Office, Cangzhou Central Hospital, No 16 Xinhua Road, Cangzhou, 061000, Hebei, China.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.03.008']
441,32184025,Nutritional and immune impairments and their effects on outcomes in early pancreatic cancer patients undergoing pancreatoduodenectomy.,"BACKGROUND & AIMS
Nutritional impairments are highly frequent in pancreatic cancer even in the early stages and have a significant impact on outcomes. The aim of this prospective study was to investigate immune and nutritional impairments, their interrelations and impacts on outcomes in an unselected cohort of patients scheduled for pancreatoduodenectomy due to suspicion of pancreatic cancer.
METHODS
All consecutive patients scheduled for pancreatoduodenectomy at Vilnius University Hospital Santaros Klinikos between January 2016 and November 2018 were recruited into the study according to the inclusion/exclusion criteria. Patients were randomly allocated into the groups of nutritional intervention with immunonutrition vs. control and stratified into the groups of pancreatic ductal adenocarcinoma (PDAC) vs. other pancreatic tumors. Nutritional evaluation included screening (NRS 2002), anthropometric measurements, bioelectrical impedance analysis and lumbar skeletal muscle index (LSMI). Inflammatory indicators were measured before and after surgery. Surgical outcomes were assessed 30 days postoperatively using Comprehensive Complication Index (CCI).
RESULTS
Although increased nutritional risk was identified in 22.4% of patients, 41.4% were finally diagnosed with cachexia. While cachexia was predominantly diagnosed in underweight patients, sarcopenia was detected across all BMI categories and 11.7% of obese patients had sarcopenia. Decreased LSMI was identified in 52.5% of patients as compared to decreased phase angle in 39% of patients and decreased fat free mass index in only 3.4% of patients. Regression model indicate a large effect of nutritional indicators on CCI (R 2 coefficient 71.1%). In comparison to patients with other pancreatic tumors, patients with PDAC had a characteristic pattern of increased systemic inflammation prior to surgery and decreased inflammation postoperatively (p = 0.02).
CONCLUSIONS
A high rate of nutritional impairments was identified in our cohort of patients with early pancreatic cancer, including abnormal body composition phenotypes. They produced negative effects on postoperative outcomes. The highest diagnostic rates were obtained with LSMI measurement, while the highest value for prognostication was attained with the inclusion of multiple objective nutritional state indicators.",2020,Decreased LSMI was identified in 52.5% of patients as compared to decreased phase angle in 39% of patients and decreased fat free mass index in only 3.4% of patients.,"['All consecutive patients scheduled for pancreatoduodenectomy at Vilnius University Hospital Santaros Klinikos between January 2016 and November 2018 were recruited into the study according to the inclusion/exclusion criteria', 'unselected cohort of patients scheduled for pancreatoduodenectomy due to suspicion of pancreatic cancer', 'patients with early pancreatic cancer, including abnormal body composition phenotypes', 'early pancreatic cancer patients undergoing pancreatoduodenectomy']",['nutritional intervention with immunonutrition vs. control and stratified into the groups of pancreatic ductal adenocarcinoma (PDAC) vs. other pancreatic tumors'],"['fat free mass index', 'Inflammatory indicators', 'systemic inflammation', 'Nutritional evaluation included screening (NRS 2002), anthropometric measurements, bioelectrical impedance analysis and lumbar skeletal muscle index (LSMI', 'Decreased LSMI', 'Comprehensive Complication Index (CCI', 'nutritional risk', 'highest diagnostic rates']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0162536', 'cui_str': 'Bioelectrical Impedance'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",,0.0213197,Decreased LSMI was identified in 52.5% of patients as compared to decreased phase angle in 39% of patients and decreased fat free mass index in only 3.4% of patients.,"[{'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Tumas', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania. Electronic address: jaroslav.tumas@santa.lt.'}, {'ForeName': 'Birute', 'Initials': 'B', 'LastName': 'Tumiene', 'Affiliation': 'Department of Human and Medical Genetics, Institute of Biomedical Sciences, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Jolita', 'Initials': 'J', 'LastName': 'Jurkeviciene', 'Affiliation': 'Department of Physiology, Biochemistry, Microbiology and Laboratory Medicine, Institute of Biomedical Sciences, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Eugenijus', 'Initials': 'E', 'LastName': 'Jasiunas', 'Affiliation': 'Centre of Informatics and Development, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.'}, {'ForeName': 'Audrius', 'Initials': 'A', 'LastName': 'Sileikis', 'Affiliation': 'Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.02.029']
442,32184026,Body composition during outpatient treatment of severe acute malnutrition: Results from a randomised trial testing different doses of ready-to-use therapeutic foods.,"BACKGROUND & AIMS
Treatment of children with uncomplicated severe acute malnutrition (SAM) is based on ready-to-use therapeutic foods (RUTF) prescribed based on body weight and administered at home. Treatment performance is typically monitored through weight gain. We previously reported that a reduced dose of RUTF resulted in weight gain velocity similar to standard dose. Here we investigate the change in body composition of children treated for SAM and compare it to community controls, and describe the effect of a reduced RUTF dose on body composition at recovery.
METHODS
Body composition was measured via bio-electrical impedance analysis at admission and recovery among a sub-group of children with SAM participating in a clinical trial and receiving a reduced or a standard dose of RUTF. Non-malnourished children were measured to represent community controls. Linear mixed regression models were fitted.
RESULTS
We obtained body composition data from 452 children at admission, 259 at recovery and 97 community controls. During SAM treatment the average weight increased by 1.20 kg of which 0.55 kg (45%) was fat-free mass (FFM) and 0.67 kg (55%) was fat mass (FM). At recovery, children treated for SAM had 1.27 kg lower weight, 0.38 kg lower FFM, and 0.90 kg lower FM compared to community controls. However, their fat-free mass index (FFMI) was not different from community controls (Δ0.2 kg/m 2 ; 95% CI -0.1, 0.4). No differences were observed in FFM, FM or fat mass index (FMI) between the study arms at recovery. However, FFMI was 0.35 kg/m 2 higher at recovery with the reduced compared to standard dose (p = 0.007) due to slightly lower height (Δ0.22 cm; p = 0.25) and higher FFM (Δ0.11 kg; p = 0.078) in the reduced dose group.
CONCLUSIONS
Almost half of the weight gain during SAM treatment was FFM. Compared to community controls, children recovered from SAM had a lower FM while their height-adjusted FFM was similar. There was no evidence of a differential effect of a reduced RUTF dose on the tissue accretion of treated children when compared to standard treatment.",2020,"No differences were observed in FFM, FM or fat mass index (FMI) between the study arms at recovery.","['severe acute malnutrition', '452 children at admission, 259\xa0at recovery and 97 community controls', 'children with SAM participating in a clinical trial and receiving a reduced or a standard dose of RUTF', 'children with uncomplicated severe acute malnutrition (SAM']",['RUTF'],"['Body composition', 'FFMI', 'average weight', 'fat-free mass index (FFMI', 'FFM, FM or fat mass index (FMI', 'tissue accretion', 'weight gain velocity', 'weight gain', 'FFM']","[{'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",[],"[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0333038', 'cui_str': 'Accretion'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]",452.0,0.169736,"No differences were observed in FFM, FM or fat mass index (FMI) between the study arms at recovery.","[{'ForeName': 'Suvi T', 'Initials': 'ST', 'LastName': 'Kangas', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark; Expertise and Advocacy Department, Action Against Hunger (ACF), Paris, France. Electronic address: suvi_kangas@hotmail.com.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Kaestel', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Salpéteur', 'Affiliation': 'Expertise and Advocacy Department, Action Against Hunger (ACF), Paris, France.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Nikièma', 'Affiliation': 'Nutrition and Health Department, Action Against Hunger (ACF) Mission in Burkina Faso, Burkina Faso.'}, {'ForeName': 'Leisel', 'Initials': 'L', 'LastName': 'Talley', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, USA.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Briend', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark; Center for Child Health Research, University of Tampere School of Medicine, FIN-33014 Tampere University, Tampere, Finland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Friis', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Wells', 'Affiliation': 'Childhood Nutrition Research Centre, UCL Great Ormond Street Institute of Child Health, London, UK; Population, Policy, and Practice Programme, UCL Great Ormond Street Institute of Child Health, London, UK.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.02.038']
443,31888569,"The FANMI (""my FAMILY"" in Creole) study to evaluate community-based cohort care for adolescent and young women living with HIV in Haiti: protocol for a randomized controlled trial.","BACKGROUND
Adolescent girls and young women living with HIV in resource-limited settings have the poorest health outcomes of any age group, due in part to poor retention in care. Differentiated models of HIV care that target the specific challenges of young people living with HIV are urgently needed.
METHODS
The FANMI study is an unblinded randomized controlled trial designed to evaluate the efficacy of an adolescent-specific model of HIV care in Port-au-Prince, Haiti. The FANMI intervention places newly young women living with HIV who are not currently on ART or on ART ≤ 3 months, in cohorts of 5-10 peers to receive monthly group HIV care in a community location. In contrast, participants in the standard care arm receive routine HIV care and individual counseling each month in GHESKIO's Adolescent Clinic. A total of 160 participants ages 16-23 years old are being randomized on a 1:1 basis. The primary outcome is retention in HIV care defined as being alive and in care at 12 months after enrollment. Secondary outcomes include viral suppression at 12 months, sexual risk behaviors, acceptability of the FANMI intervention, and health care utilization and costs.
DISCUSSION
The FANMI study evaluates a novel community-based cohort model of HIV care aimed at improving retention in care and reducing risk behaviors for HIV transmission among adolescent girls and young women living with HIV. Specifically, the FANMI model of care addresses social isolation by placing participants in cohorts of 5-10 peers to provide intensified peer support and makes HIV health management a group norm; reduces stigma and improves convenience by providing care in a community setting; and integrates clinical care and social support by the same providers to streamline care and promote long-term patient-provider relationships. If shown to be effective, the FANMI intervention may serve as a model of HIV care for improving retention among hard-to-reach adolescents and young adults in Haiti and could be adapted for other high-risk groups globally.
TRIAL REGISTRATION
Identifier: NCT03286504, Registered September 18, 2017.",2019,"Secondary outcomes include viral suppression at 12 months, sexual risk behaviors, acceptability of the FANMI intervention, and health care utilization and costs.
","['adolescent girls and young women living with HIV', 'young people living with HIV', 'adolescent and young women living with HIV in Haiti', '160 participants ages 16-23\u2009years old', 'places newly young women living with HIV who are not currently on ART or on ART ≤ 3 months, in cohorts of 5-10 peers to receive monthly group HIV care in a community location', 'Adolescent girls and young women living with HIV in resource-limited settings']","['FANMI intervention', 'routine HIV care and individual counseling']","['viral suppression at 12\u2009months, sexual risk behaviors, acceptability of the FANMI intervention, and health care utilization and costs', 'retention in HIV care defined as being alive and in care']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}]",160.0,0.0897202,"Secondary outcomes include viral suppression at 12 months, sexual risk behaviors, acceptability of the FANMI intervention, and health care utilization and costs.
","[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Seo', 'Affiliation': 'Center for Global Health, Weill Cornell Medical College, New York, NY, USA. grs2013@med.cornell.edu.'}, {'ForeName': 'Joseph Marie Bajo', 'Initials': 'JMB', 'LastName': 'Joseph', 'Affiliation': ""Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Confident', 'Affiliation': ""Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Jean', 'Affiliation': ""Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.""}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Louis', 'Affiliation': ""Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.""}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Bell', 'Affiliation': ""Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.""}, {'ForeName': 'Rose Cardelle', 'Initials': 'RC', 'LastName': 'Riche', 'Affiliation': ""Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.""}, {'ForeName': 'Marie Elmase', 'Initials': 'ME', 'LastName': 'Belizaire', 'Affiliation': ""Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.""}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Rouzier', 'Affiliation': 'Center for Global Health, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Apollon', 'Affiliation': ""Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.""}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Reif', 'Affiliation': 'Center for Global Health, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Rivera', 'Affiliation': 'Center for Global Health, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Abrams', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Heejung', 'Initials': 'H', 'LastName': 'Bang', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of California, Davis, CA, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Schackman', 'Affiliation': 'Healthcare Policy and Research, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fitzgerald', 'Affiliation': 'Center for Global Health, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Jean W', 'Initials': 'JW', 'LastName': 'Pape', 'Affiliation': 'Center for Global Health, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'McNairy', 'Affiliation': 'Center for Global Health, Weill Cornell Medical College, New York, NY, USA.'}]",BMC public health,['10.1186/s12889-019-8065-6']
444,32179023,Cost and reimbursement of providing routine vaccines in outpatient obstetrician/gynecologist settings.,"OBJECTIVE
To determine the costs and reimbursement associated with running a vaccine program in 5 obstetrics/gynecology practices in Colorado that had participated in a 3-year randomized, controlled trial focused on increasing vaccination in this setting.
MATERIALS AND METHODS
This was a secondary analysis on costs from 5 clinics participating in a cluster-randomized controlled trial that assessed the effectiveness of a multimodal intervention to improve vaccination rates in outpatient obstetrics/gynecology clinics in central Colorado. The intervention included designation of an immunization champion within the practice, purchasing recommended vaccines for the practice, guidance on storage and management, implementing practices for routine identification of eligible patients for vaccination using the medical record, implementation of standing orders for vaccination, and vaccine administration to patients. Data on costs were gathered from office invoices, claims data, surveys and in-person observations during the course of the trial. These data incorporated supply and personnel costs for administering vaccines to individual patients that were derived from a combination of time-motion studies of staff and provider clinical activity, and practice reports, as well as costs related to maintaining the vaccination program at the practice level, which were derived from practice reports and invoices. Cost data for personnel time during visits in which vaccination was assessed and/or discussed, but no vaccine was given to the patient were also included in the main analysis. Data on practice revenue were derived from practice reimbursement records. All costs were described in 2014 dollars. The primary analysis was the proportion of costs for the program that were reimbursed, aggregated over all years of the study and combining all vaccines and practices, separated by obstetrics vs gynecology patients.
RESULTS
Collectively the 5 clinics served >40,000 patient during the study period and served a population that was 16% Medicaid. Over the 3-year observation period, there were 6573 vaccination claims made collectively by the practices (4657 for obstetric patients, 1916 for gynecology patients). The most expensive component of the program was the material costs of the vaccines themselves, which ranged from a low of $9.67 for influenza vaccines, to a high of $141.40 for human papillomavirus vaccine. Staff costs for assessing and delivering vaccines during patient visits were minimal ($0.09-$1.24 per patient visit depending on the practice and whether an obstetrics or gynecology visit was being assessed) compared with staff costs for maintaining the program at a practice level (ie, assessing inventory, ordering and stocking vaccines; $0.89-$105.89 per vaccine dose given). When assessing all costs compared with all reimbursement, we found that vaccines for obstetrics patients were reimbursed at 159% of the costs over the study period, and for gynecology patients at 97% of the costs. Overall, the vaccination program was financially favorable across the practices, averaging 125% reimbursement of costs across the three study years.
CONCLUSION
Providing routine vaccines to patients in the ambulatory obstetrics/gynecology setting is generally not financially prohibitive for practices, and may even be financially beneficial, though there is variability between practices that can affect the overall reimbursement margin.",2020,"Overall, the vaccination program was financially favorable across the practices, averaging 125% reimbursement of costs across the three study years.
","['patients in the ambulatory obstetrics/gynecology setting', 'Outpatient Obstetrician/Gynecologist Settings', 'Collectively the 5 clinics served >40,000 patient during the study period and served a population that was 16% Medicaid', 'five obstetrics/gynecology (Ob/Gyn) practices in Colorado that had participated', 'outpatient Ob/Gyn clinics in central Colorado']","['running a vaccine program', 'multimodal intervention']","['Staff costs', 'proportion of costs', 'vaccination rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0334897', 'cui_str': 'Obstetrician (occupation)'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist (occupation)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.0585529,"Overall, the vaccination program was financially favorable across the practices, averaging 125% reimbursement of costs across the three study years.
","[{'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Dempsey', 'Affiliation': 'Department of Pediatrics, University of Colorado Denver; Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado Denver. Electronic address: Amanda.dempsey@cuanschutz.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pyrzanowski', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado Denver.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'School of Pharmacy, University of Colorado Denver.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Brewer', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado Denver.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Sevick', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado Denver.'}, {'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': 'Department of Pediatrics, University of Colorado Denver; Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado Denver.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.02.051']
445,32178856,Effectiveness of implementing link nurses and audits and feedback to improve nurses' compliance with standard precautions: A cluster randomized controlled trial.,"BACKGROUND
To prevent health care-associated infections, health organizations recommend that health care workers stringently observe standard precautions (SPs). Nevertheless, compliance with SPs is still suboptimal, emphasizing the need for improvement interventions.
METHODS
A cluster randomized controlled trial with a pretest-post-test design was conducted with 121 clinical nurses who worked in different wards of a university hospital. The intervention group (n = 61) had 3 infection control link nurses nominated and attended systematic audits and feedback. The control group (n = 60) received only the standard multimodal approach used in the hospital. Pre- and post-test assessment of SPs compliance was performed via the World Health Organization observational hand hygiene form and Compliance with Standard Precaution Scale Italian version.
RESULTS
At the post-test, nurses in the intervention group reported significantly increased compliance with hand hygiene, whereas no significant improvement was found in the control group. Nurses in both groups reported significantly increased Compliance with Standard Precaution Scale Italian version scores; however, a higher increase and practical significance was observed in the intervention group. Participants who improved their scores were also compared between groups, showing a significantly greater increase of individual scores in intervention group compared to the control group.
CONCLUSIONS
The findings of this study provide significant practical implications for hospitals seeking to improve compliance with SPs among nurses, showing the effectiveness of using infection control link nurses combined with systematic audits and feedback.",2020,"At the post-test, nurses in the intervention group reported significantly increased compliance with hand hygiene, whereas no significant improvement was found in the control group.",['121 clinical nurses who worked in different wards of a university hospital'],"['3 infection control link nurses nominated and attended systematic audits and feedback', 'standard precautions', 'implementing link nurses and audits and feedback']","['Compliance with Standard Precaution Scale Italian version scores', 'compliance with hand hygiene', 'individual scores']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0085557', 'cui_str': 'Infection Control'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1443867', 'cui_str': 'Standard precautions'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1443867', 'cui_str': 'Standard precautions'}, {'cui': 'C0222045'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",,0.0429569,"At the post-test, nurses in the intervention group reported significantly increased compliance with hand hygiene, whereas no significant improvement was found in the control group.","[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Donati', 'Affiliation': 'Department of Biomedicine and Prevention, Tor Vergata University of Rome, Rome, Italy. Electronic address: d.donati@unicampus.it.'}, {'ForeName': 'Ginevra Azzurra', 'Initials': 'GA', 'LastName': 'Miccoli', 'Affiliation': 'Infection Prevention and Control Team, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cianfrocca', 'Affiliation': 'Department of Biomedicine and Prevention, Tor Vergata University of Rome, Rome, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Di Stasio', 'Affiliation': 'Institute of Biochemistry and Clinical Biochemistry, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'De Marinis', 'Affiliation': 'Research Unit Nursing Science, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tartaglini', 'Affiliation': 'Research Unit Nursing Science, Campus Bio-Medico University of Rome, Rome, Italy.'}]",American journal of infection control,['10.1016/j.ajic.2020.01.017']
446,31711065,Repetitive transcranial magnetic stimulation targeting the insular cortex for reduction of heavy drinking in treatment-seeking alcohol-dependent subjects: a randomized controlled trial.,"Insula responses to drug cues are correlated with cravings, and lesions in this area reduce nicotine seeking. Here, we investigated the potential efficacy of repetitive transcranial magnetic stimulation (rTMS) targeting the insula in alcohol addiction. Treatment-seeking alcohol-dependent patients (Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition; N = 56) participated in this double-blind, sham-controlled, randomized trial. Participants received 10 Hz rTMS or sham using an H8 coil, 5 days a week for 3 weeks. Stimulation targeted insular cortex and overlaying regions bilaterally, while excluding anterior prefrontal areas. Craving and self-reported as well as biomarker-based drinking measures were collected at baseline, during treatment, and through 12 weeks. Resting-state magnetic resonance imaging (rsMRI) data were collected before and after treatment. Task-based MRI was used to probe brain correlates of reward processing, affective responses, and alcohol following completion of treatment. A marked overall decrease in craving and drinking measures was observed during treatment, but did not differ between rTMS or sham stimulation. Both groups equally increased their alcohol use following completion of treatment and through the 12-week follow-up. Analysis using seeds in the insula identified differences in resting-state connectivity between active and sham groups at completion of treatment, potentially indicating an ability of treatment to modify insula function. However, while each task robustly replicated brain responses established in the literature, no effects of rTMS were found. Collectively, this study does not support efficacy of rTMS targeting the insula in alcohol addiction.",2020,"Analysis using seeds in the insula identified differences in resting-state connectivity between active and sham groups at completion of treatment, potentially indicating an ability of treatment to modify insula function.",['treatment-seeking alcohol-dependent subjects'],"['Repetitive transcranial magnetic stimulation', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS', '10\u2009Hz rTMS']","['heavy drinking', 'craving and drinking measures']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0893144,"Analysis using seeds in the insula identified differences in resting-state connectivity between active and sham groups at completion of treatment, potentially indicating an ability of treatment to modify insula function.","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Perini', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden. irene.perini@liu.se.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Kämpe', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Theodor', 'Initials': 'T', 'LastName': 'Arlestig', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Karlsson', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Löfberg', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Pietrzak', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'Department of Life Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0565-7']
447,32162213,Health Demands Moderate the Link Between Willpower Beliefs and Physical Activity in Patients with Knee Osteoarthritis.,"BACKGROUND
Regular physical activity (PA) was found to alleviate pain and improve functioning among patients with osteoarthritis of the knee (OAK). Heightened health demands due to OAK severity, body mass index (BMI), and depressive symptoms may require self-regulatory strategies to engage in more PA. Research on willpower-the capacity to exert self-control-suggests that believing that willpower is a nonlimited rather than a limited resource predicts effective self-regulation specifically when demands are high. The present study examines the association of OAK patients' willpower beliefs with their daily PA as a function of health demands.
METHODS
To identify the moderating role of OAK severity (WOMAC), BMI, and depressive symptoms (CES-D) on the link between willpower beliefs and objectively assessed PA over a 7-day period, baseline data of a registered randomized controlled trial with 243 patients (M age = 65.47 years, SD = 0.49) were examined in secondary analyses.
RESULTS
Moderation analyses revealed that overall positive associations of willpower beliefs with PA were further qualified by OAK severity, BMI, and depressive symptoms. When patients faced less health demands, believing that willpower is nonlimited was associated with more PA. When health demands were higher, willpower beliefs were not associated with PA.
CONCLUSION
OAK patients' willpower beliefs were associated with PA. However, facing more health demands seemed to erase this beneficial link. Improving willpower beliefs by way of intervention may help to shed more light on predictive direction and ways to overcome barriers to regular physical activity.",2020,"When health demands were higher, willpower beliefs were not associated with PA.
","['243 patients (M age \u2009=\u200965.47\xa0years, SD\u2009=\u20090.49', 'patients with osteoarthritis of the knee (OAK', 'Patients with Knee Osteoarthritis']",['Regular physical activity (PA'],"['OAK severity, BMI, and depressive symptoms', 'OAK severity (WOMAC), BMI, and depressive symptoms (CES-D']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0330302', 'cui_str': 'Quercus'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0330302', 'cui_str': 'Quercus'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",243.0,0.0176824,"When health demands were higher, willpower beliefs were not associated with PA.
","[{'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Di Maio', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Habelschwerdter Allee 45, D-14195, Berlin, Germany. sally.dimaio@fu-berlin.de.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Keller', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Habelschwerdter Allee 45, D-14195, Berlin, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Job', 'Affiliation': 'Faculty of Psychology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Felsenberg', 'Affiliation': 'Center for Muscle and Bone Research, Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Ertel', 'Affiliation': 'Department of Traumatology and Reconstructive Surgery, Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Schwarzer', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Habelschwerdter Allee 45, D-14195, Berlin, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Knoll', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Habelschwerdter Allee 45, D-14195, Berlin, Germany.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09865-w']
448,31163231,Efficacy and safety of a novel topical minocycline foam for the treatment of moderate to severe acne vulgaris: A phase 3 study.,"BACKGROUND
FMX101 4% topical minocycline foam has been shown to be an effective and safe treatment for acne vulgaris (AV).
OBJECTIVE
To further evaluate the efficacy and safety of FMX101 4% in treating moderate to severe acne vulgaris.
METHODS
A 12-week, multicenter, randomized (1:1), double-blind, vehicle-controlled study was conducted. Coprimary end points were the absolute change in inflammatory lesion count from baseline and the rate of treatment success (Investigator's Global Assessment score of 0 or 1 with a ≥2-grade improvement).
RESULTS
There were 1488 participants in the intent-to-treat population. The FMX101 4% group had significantly greater reductions in the number of inflammatory lesions from baseline (P < .0001) and a greater rate of treatment success based on Investigator's Global Assessment (P < .0001) versus the foam vehicle group at week 12. FMX101 4% was generally safe and well tolerated.
LIMITATIONS
The efficacy and safety of FMX101 4% were not characterized in participants with mild AV.
CONCLUSION
FMX101 4% topical minocycline foam was effective and safe for the treatment of moderate to severe AV.",2020,FMX101 4% group had significantly greater reductions in the number of inflammatory lesions from baseline (P<.0001) and a greater rate of IGA treatment success (P<.0001) vs foam vehicle group at week 12.,"['subjects with mild AV', '1488 subjects were in the intent-to-treat population', 'Moderate-to-Severe Acne Vulgaris']","['minocycline', 'Novel Topical Minocycline Foam', 'FMX101']","['effective and safe', 'absolute change in inflammatory lesion count', 'rate of IGA treatment success', 'number of inflammatory lesions', 'efficacy and safety', 'Efficacy and Safety', 'safe and well-tolerated']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1488.0,0.209026,FMX101 4% group had significantly greater reductions in the number of inflammatory lesions from baseline (P<.0001) and a greater rate of IGA treatment success (P<.0001) vs foam vehicle group at week 12.,"[{'ForeName': 'Tooraj Joseph', 'Initials': 'TJ', 'LastName': 'Raoof', 'Affiliation': 'T. Joseph Raoof MD Inc/Encino Research Center, Encino, CA.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Hooper', 'Affiliation': 'Delricht Research, New Orleans, LA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Moore', 'Affiliation': 'Arlington Research Center, Arlington, TX; Baylor University Medical Center, Dallas, TX.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zaiac', 'Affiliation': 'Department of Dermatology, Herbert Wertheim College of Medicine, Florida International University, Miami, FL; Greater Miami Skin and Laser Center, Miami Beach, FL.'}, {'ForeName': 'Tory', 'Initials': 'T', 'LastName': 'Sullivan', 'Affiliation': 'Sullivan Dermatology, North Miami Beach, FL.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Kircik', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Lain', 'Affiliation': 'Austin Institute for Clinical Research, Austin, TX.'}, {'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Jankicevic', 'Affiliation': 'Foamix Pharmaceuticals, Inc., Bridgewater, NJ.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Stuart', 'Affiliation': 'Foamix Pharmaceuticals, Inc., Bridgewater, NJ. Electronic address: iain.stuart@foamix.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.05.078']
449,31566680,Clinical Outcomes in Early Breast Cancer With a High 21-Gene Recurrence Score of 26 to 100 Assigned to Adjuvant Chemotherapy Plus Endocrine Therapy: A Secondary Analysis of the TAILORx Randomized Clinical Trial.,"Importance
A high 21-gene recurrence score (RS) by breast cancer assay is prognostic for distant recurrence of early breast cancer after local therapy and endocrine therapy alone, and for chemotherapy benefit.
Objective
To describe clinical outcomes for women with a high RS who received adjuvant chemotherapy plus endocrine therapy in the TAILORx trial, a population expected to have a high distant recurrence rate with endocrine therapy alone.
Design, Setting, and Participants
In this secondary analysis of data from a multicenter randomized clinical trial, 1389 women with hormone receptor-positive, ERBB2-negative, axillary node-negative breast cancer, and a high RS of 26 to 100 were prospectively assigned to receive adjuvant chemotherapy in addition to endocrine therapy. The analysis was conducted on May 12, 2019.
Interventions
The adjuvant chemotherapy regimen was selected by the treating physician.
Main Outcomes and Measures
Freedom from recurrence of breast cancer at a distant site, and freedom from recurrence, second primary cancer, and death (also known as invasive disease-free survival [IDFS]).
Results
Among the 9719 eligible women, with a mean age of 56 years (range 23-75 years), 1389 (14%) had a recurrence score of 26 to 100, of whom 598 (42%) had an RS of 26 to 30 and 791 (58%) had an RS of 31 to 100. The most common chemotherapy regimens included docetaxel/cyclophosphamide in 589 (42%), an anthracycline without a taxane in 334 (24%), an anthracycline and taxane in 244 (18%), cyclophosphamide/methotrexate/5-fluorouracil in 52 (4%), other regimens in 81 (6%), and no chemotherapy in 89 (6%). At 5 years, the estimated rate of freedom from recurrence of breast cancer at a distant site was 93.0% (standard error [SE], 0.8%), freedom of recurrence of breast cancer at a distant and/or local regional site 91.0% (SE, 0.8%), IDFS 87.6% (SE, 1.0%), and overall survival 95.9% (SE, 0.6%).
Conclusions and Relevance
The estimated rate of freedom from recurrence of breast cancer at a distant site in women with an RS of 26 to 100 treated largely with taxane and/or anthracycline-containing adjuvant chemotherapy regimens plus endocrine therapy in the prospective TAILORx trial was 93% at 5 years, an outcome better than expected with endocrine therapy alone in this population.
Trial Registration
ClinicalTrials.gov identifier: NCT00310180.",2020,"At 5 years, the estimated rate of freedom from recurrence of breast cancer at a distant site was 93.0% (standard error [SE], 0.8%), freedom of recurrence of breast cancer at a distant and/or local regional site 91.0% (SE, 0.8%), IDFS 87.6% (SE, 1.0%), and overall survival 95.9% (SE, 0.6%).
","['1389 women with hormone receptor-positive, ERBB2-negative, axillary node-negative breast cancer, and a high RS of 26 to 100', 'women with a high RS who received', 'Early Breast Cancer With a High 21-Gene Recurrence Score of 26 to 100', '9719 eligible women, with a mean age of 56 years (range 23-75 years), 1389 (14%) had a recurrence score of 26 to 100, of whom 598 (42%) had an RS of 26 to 30 and 791 (58%) had an RS of 31 to 100']","['cyclophosphamide/methotrexate/5-fluorouracil', 'taxane and/or anthracycline-containing adjuvant chemotherapy regimens plus endocrine therapy', 'endocrine therapy alone', 'adjuvant chemotherapy in addition to endocrine therapy', 'anthracycline without a taxane', 'docetaxel/cyclophosphamide', 'adjuvant chemotherapy plus endocrine therapy', 'anthracycline and taxane', 'Adjuvant Chemotherapy Plus Endocrine Therapy']","['Measures\n\n\nFreedom from recurrence of breast cancer at a distant site, and freedom from recurrence, second primary cancer, and death (also known as invasive disease-free survival [IDFS', 'estimated rate of freedom from recurrence of breast cancer', 'freedom of recurrence of breast cancer', 'overall survival']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0751623', 'cui_str': 'Second Cancer'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1389.0,0.21629,"At 5 years, the estimated rate of freedom from recurrence of breast cancer at a distant site was 93.0% (standard error [SE], 0.8%), freedom of recurrence of breast cancer at a distant and/or local regional site 91.0% (SE, 0.8%), IDFS 87.6% (SE, 1.0%), and overall survival 95.9% (SE, 0.6%).
","[{'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'Dana Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Della F', 'Initials': 'DF', 'LastName': 'Makower', 'Affiliation': 'Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Saphner', 'Affiliation': 'Aurora Cancer Center (formerly Vince Lombardi Cancer Clinic), Two Rivers, Wisconsin.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Badve', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Virginia G', 'Initials': 'VG', 'LastName': 'Kaklamani', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Maccon M', 'Initials': 'MM', 'LastName': 'Keane', 'Affiliation': 'Cancer Trials Ireland, Dublin, Ireland.'}, {'ForeName': 'Henry L', 'Initials': 'HL', 'LastName': 'Gomez', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru.'}, {'ForeName': 'Pavan S', 'Initials': 'PS', 'LastName': 'Reddy', 'Affiliation': 'Cancer Center of Kansas, Wichita, Kansas.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Goggins', 'Affiliation': 'Fox Valley Hematology and Oncology, Appleton, Wisconsin.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Toppmeyer', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Brufsky', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Berenberg', 'Affiliation': 'University of Hawaii Cancer Center, Honolulu, Hawaii.'}, {'ForeName': 'Catalin', 'Initials': 'C', 'LastName': 'Mahalcioiu', 'Affiliation': 'McGill University, Montreal, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Desbiens', 'Affiliation': 'Universite Laval, Quebec, Canada.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Dees', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'the Massey Cancer Center, Virginia Commonwealth University School of Medicine, Richmond.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Olson', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Wood', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Lively', 'Affiliation': 'National Institutes of Health, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Soonmyung', 'Initials': 'S', 'LastName': 'Paik', 'Affiliation': 'NSABP Pathology Office, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Ellis', 'Affiliation': 'Washington University, St Louis, Missouri.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Abrams', 'Affiliation': 'National Institutes of Health, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Indiana University Hospital, Indianapolis.'}]",JAMA oncology,['10.1001/jamaoncol.2019.4794']
450,31999839,Long-term results of frontline dasatinib in chronic myeloid leukemia.,"BACKGROUND
Dasatinib is a second-generation tyrosine kinase inhibitor that, when used as frontline therapy, produces more and faster cytogenetic and molecular responses compared with imatinib. The authors report the long-term follow-up from the first study using dasatinib as initial therapy for chronic-phase chronic myeloid leukemia.
METHODS
Between November 2005 and August 2014, patients were randomly assigned to receive 100 mg daily or 50 mg twice daily. After June 2009, all patients started with 100 mg daily.
RESULTS
With a median follow-up of 6.5 years, 94 of 149 treated patients (63%) were still receiving dasatinib on study. The median patient age was 48 years (interquartile range, 37-55 years), and 9% of patients had a high risk Sokal risk score. The cumulative complete cytogenetic response rate at 11 years was 92.6%, the major molecular response (MR) rate was 88.2%, and the MR4.5 rate (indicating a ≥4.5-log reduction in BCR-ABL1 transcripts) was 79.5%. The median time to a major MR and MR4.5 was 6 and 23 months, respectively. A sustained MR4.5 (≥2 years) was achieved in 82 patients (55%). The 10-year overall survival, transformation-free survival, event-free survival, and failure-free survival rates were 89%, 95%, 86%, and 65%, respectively. Univariate analysis showed that the achievement of a complete MR was associated with improved overall survival. The most common reasons for treatment discontinuation were toxicity and elective discontinuation. The most common treatment-emergent grade 3 and 4 adverse events were fatigue, thrombocytopenia, and infections.
CONCLUSIONS
After this long-term follow-up, dasatinib continues to show an excellent safety profile and produces rapid cytogenetic responses and MRs, durable deep MRs, and excellent long-term survival outcomes in patients with chronic-phase chronic myeloid leukemia.",2020,"The 10-year overall survival, transformation-free survival, event-free survival, and failure-free survival rates were 89%, 95%, 86%, and 65%, respectively.","['chronic myeloid leukemia', 'The median patient age was 48\xa0years (interquartile range, 37-55\xa0years), and 9% of patients had a high risk Sokal risk score', 'Between November 2005 and August 2014', 'chronic-phase chronic myeloid leukemia', 'With a median follow-up of 6.5\xa0years, 94 of 149 treated patients (63%) were still receiving dasatinib on study', 'patients with chronic-phase chronic myeloid leukemia']",['100\xa0mg daily or 50\xa0mg twice daily'],"['cumulative complete cytogenetic response rate', 'toxicity and elective discontinuation', 'MR4.5 rate', 'rapid cytogenetic responses and MRs, durable deep MRs, and excellent long-term survival outcomes', 'median time to a major MR and MR4.5', 'fatigue, thrombocytopenia, and infections', 'overall survival', '10-year overall survival, transformation-free survival, event-free survival, and failure-free survival rates', 'major molecular response (MR) rate']","[{'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023474', 'cui_str': 'Granulocytic Leukemia, Chronic, Stable-Phase'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.12634,"The 10-year overall survival, transformation-free survival, event-free survival, and failure-free survival rates were 89%, 95%, 86%, and 65%, respectively.","[{'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Maiti', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Keyur P', 'Initials': 'KP', 'LastName': 'Patel', 'Affiliation': 'Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Masarova', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Borthakur', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ravandi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Srdan', 'Initials': 'S', 'LastName': 'Verstovsek', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ferrajoli', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Zeev', 'Initials': 'Z', 'LastName': 'Estrov', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Tapan M', 'Initials': 'TM', 'LastName': 'Kadia', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Graciela M', 'Initials': 'GM', 'LastName': 'Nogueras-González', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Skinner', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Poku', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'DellaSala', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Rajyalakshmi', 'Initials': 'R', 'LastName': 'Luthra', 'Affiliation': 'Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Elias J', 'Initials': 'EJ', 'LastName': 'Jabbour', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California, Irvine, California.'}, {'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Cancer,['10.1002/cncr.32627']
451,32173247,Phase II Trial of Carfilzomib Plus Irinotecan in Patients With Small-cell Lung Cancer Who Have Progressed on Prior Platinum-based Chemotherapy.,"INTRODUCTION
The purpose of this study was to evaluate the efficacy and tolerability of carfilzomib plus irinotecan (C/I) in patients with relapsed small-cell lung cancer (SCLC).
PATIENTS AND METHODS
Patients with SCLC who progressed after 1 platinum-containing regimen for recurrent or metastatic disease were eligible. Patients were stratified as: sensitive (SS) (progressive disease > 90 days after chemotherapy) or refractory (RS) (progressive disease 30 to 90 days after chemotherapy) and received up to 6 cycles of C/I; imaging was performed every 2 cycles. The primary endpoint was 6-month overall survival (OS).
RESULTS
All 62 patients enrolled were evaluable for efficacy and adverse events. 6-month OS was 59% in the platinum SS and 54% in the platinum RS. The overall response rate was 21.6% (2.7% complete response, 18.9% partial response) in SS (n = 37) and 12.5% (all partial response) in RS (n = 25). The disease control rate was 68% (SS) and 56% (RS). Progression-free survival and OS were 3.6 months (95% confidence interval [CI], 2.6-4.6 months) and 6.9 months (95% CI, 4.3-12.3 months) in SS, and 3.3 months (95% CI, 1.8-3.9 months) and 6.8 months (95% CI, 4.1-11 months) in RS. Twenty-nine (47%) patients experienced ≥ grade 3 adverse events; 8 (12.9%) subjects had grade 4 toxicities. Three treatment-related deaths occurred: myocardial infarction (possible), lung infection (possible), and sepsis (probable).
CONCLUSION
In patients with relapsed SCLC, C/I was effective in the treatment of SS and RS. With 4.8% grade 5 toxicity, C/I is a viable option for relapsed patients with SCLC with performance status 0 to 1, particularly in platinum-resistant patients, or subjects who cannot receive immunotherapy.",2020,"Progression-free survival and OS were 3.6 months (95% confidence interval [CI], 2.6-4.6 months) and 6.9 months (95% CI, 4.3-12.3 months) in SS, and 3.3 months (95% CI, 1.8-3.9 months) and 6.8 months (95% CI, 4.1-11 months) in RS.","['patients with relapsed small-cell lung cancer (SCLC', 'Patients With Small-cell Lung Cancer', 'Patients with SCLC who progressed after 1 platinum-containing regimen for recurrent or metastatic disease were eligible', 'Patients were stratified as: sensitive (SS) (progressive disease > 90 days after chemotherapy) or refractory (RS) (progressive disease 30 to 90\xa0days after chemotherapy']","['Carfilzomib Plus Irinotecan', 'carfilzomib plus irinotecan (C/I']","['Progression-free survival and OS', 'efficacy and tolerability', 'disease control rate', 'deaths occurred: myocardial infarction (possible), lung infection (possible), and sepsis (probable', 'efficacy and adverse events', '6-month overall survival (OS', 'OS', 'overall response rate', 'grade 4 toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439083', 'cui_str': '>90 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]","[{'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",62.0,0.0260902,"Progression-free survival and OS were 3.6 months (95% confidence interval [CI], 2.6-4.6 months) and 6.9 months (95% CI, 4.3-12.3 months) in SS, and 3.3 months (95% CI, 1.8-3.9 months) and 6.8 months (95% CI, 4.1-11 months) in RS.","[{'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Arnold', 'Affiliation': 'University of Kentucky Markey Cancer Center, Lexington, KY; Division of Medical Oncology, Department of Medicine, University of Kentucky, Lexington, KY. Electronic address: susanne.arnold@uky.edu.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Chansky', 'Affiliation': 'Cancer Research and Biostatistics, Seattle, WA.'}, {'ForeName': 'Maria Q', 'Initials': 'MQ', 'LastName': 'Baggstrom', 'Affiliation': 'Department of Internal Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'Aurora Research Institute, Advocate Aurora Health, Milwaukee, WI.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Sanborn', 'Affiliation': 'Division of Medical Oncology, Providence Cancer Center, Portland, OR.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Villano', 'Affiliation': 'University of Kentucky Markey Cancer Center, Lexington, KY; Division of Medical Oncology, Department of Medicine, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Saiama N', 'Initials': 'SN', 'LastName': 'Waqar', 'Affiliation': 'Department of Internal Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hamm', 'Affiliation': 'Norton Cancer Institute, Louisville, KY.'}, {'ForeName': 'Markos', 'Initials': 'M', 'LastName': 'Leggas', 'Affiliation': 'University of Kentucky Markey Cancer Center, Lexington, KY; Department of Pharmaceutical Sciences, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Willis', 'Affiliation': 'Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rosales', 'Affiliation': 'Department of Internal Medicine, Virginia Mason, Seattle, WA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Crowley', 'Affiliation': 'Cancer Research and Biostatistics, Seattle, WA.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.01.006']
452,32053149,HSD3B1 Genotype and Clinical Outcomes in Metastatic Castration-Sensitive Prostate Cancer.,"Importance
The adrenal-restrictive HSD3B1(1245A) allele limits extragonadal dihydrotestosterone synthesis, whereas the adrenal-permissive HSD3B1(1245C) allele augments extragonadal dihydrotestosterone synthesis. Retrospective studies have suggested an association between the adrenal-permissive allele, the frequency of which is highest in white men, and early development of castration-resistant prostate cancer (CRPC).
Objective
To examine the association between the adrenal-permissive HSD3B1(1245C) allele and early development of CRPC using prospective data.
Design, Setting, and Participants
The E3805 Chemohormonal Therapy vs Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) was a large, multicenter, phase 3 trial of castration with or without docetaxel treatment in men with newly diagnosed metastatic prostate cancer. From July 28, 2006, through December 31, 2012, 790 patients underwent randomization, of whom 527 had available DNA samples. In this study, the HSD3B1 germline genotype was retrospectively determined in 475 white men treated in E3805 CHAARTED, and clinical outcomes were analyzed by genotype. Data analysis was performed from July 28, 2006, to October 17, 2018.
Interventions
Men were randomized to castration plus docetaxel, 75 mg/m2, every 3 weeks for 6 cycles or castration alone.
Main Outcomes and Measures
Two-year freedom from CRPC and 5-year overall survival, with results stratified by disease volume. Patients were combined across study arms according to genotype to assess the overall outcome associated with genotype. Secondary analyses by treatment arm evaluated whether the docetaxel outcome varied with genotype.
Results
Of 475 white men with DNA samples, 270 patients (56.8%) inherited the adrenal-permissive genotype (≥1 HSD3B1[1245C] allele). Mean (SD) age was 63 (8.7) years. Freedom from CRPC at 2 years was diminished in men with low-volume disease with the adrenal-permissive vs adrenal-restrictive genotype: 51.0% (95% CI, 40.9%-61.2%) vs 70.5% (95% CI, 60.0%-80.9%) (P = .01). Overall survival at 5 years was also worse in men with low-volume disease with the adrenal-permissive genotype: 57.5% (95% CI, 47.4%-67.7%) vs 70.8% (95% CI, 60.3%-81.3%) (P = .03). Hazard ratios were 1.89 (95% CI, 1.13-3.14; P = .02) for CRPC and 1.74 (95% CI, 1.01-3.00; P = .045) for death. There was no association between genotype and outcomes in men with high-volume disease. There was no interaction between genotype and benefit from docetaxel.
Conclusions and Relevance
Inheritance of the adrenal-permissive HSD3B1 genotype is associated with earlier castration resistance and shorter overall survival in men with low-volume metastatic prostate cancer and may help identify men more likely to benefit from escalated androgen receptor axis inhibition beyond gonadal testosterone suppression.",2020,"Hazard ratios were 1.89 (95% CI, 1.13-3.14; P = .02) for CRPC and 1.74 (95% CI, 1.01-3.00; P = .045) for death.","['Mean (SD) age was 63 (8.7) years', 'men with newly diagnosed metastatic prostate cancer', '475 white men with DNA samples, 270 patients (56.8%) inherited the adrenal-permissive genotype (≥1 HSD3B1[1245C] allele', 'From July 28, 2006, through December 31, 2012, 790 patients underwent randomization, of whom 527 had available DNA samples', 'men with high-volume disease', 'men with low-volume metastatic prostate cancer', 'Interventions\n\n\nMen', '475 white men treated in E3805 CHAARTED, and clinical outcomes were analyzed by genotype', 'Metastatic Castration-Sensitive Prostate Cancer']","['castration alone', 'castration with or without docetaxel treatment', 'castration plus docetaxel', 'E3805 Chemohormonal Therapy vs Androgen Ablation']","['Measures\n\n\nTwo-year freedom from CRPC and 5-year overall survival', 'Overall survival', 'Hazard ratios', 'docetaxel outcome varied with genotype', 'overall survival']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C4517786', 'cui_str': '475 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517805', 'cui_str': 'Five hundred and twenty-seven'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}]","[{'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]",475.0,0.105053,"Hazard ratios were 1.89 (95% CI, 1.13-3.14; P = .02) for CRPC and 1.74 (95% CI, 1.01-3.00; P = .045) for death.","[{'ForeName': 'Jason W D', 'Initials': 'JWD', 'LastName': 'Hearn', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Sweeney', 'Affiliation': 'Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Almassi', 'Affiliation': 'GU Malignancies Research Center, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Reichard', 'Affiliation': 'GU Malignancies Research Center, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Chandana A', 'Initials': 'CA', 'LastName': 'Reddy', 'Affiliation': 'Department of Radiation Oncology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Cancer Biostatistics Section, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hobbs', 'Affiliation': 'Cancer Biostatistics Section, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Jarrard', 'Affiliation': 'Department of Medical Oncology, University of Wisconsin Hospital and Clinics, Madison.'}, {'ForeName': 'Yu-Hui', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dreicer', 'Affiliation': 'University of Virginia Cancer Center, Charlottesville.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Garcia', 'Affiliation': 'Taussig Cancer Institute, Department of Hematology and Oncology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'DiPaola', 'Affiliation': 'Department of Medical Oncology, University of Kentucky, Lexington.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Sharifi', 'Affiliation': 'GU Malignancies Research Center, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}]",JAMA oncology,['10.1001/jamaoncol.2019.6496']
453,32134956,Safety of oral naltrexone in HIV-positive men who have sex with men and transgender women with alcohol use disorder and initiating antiretroviral therapy.,"HIV disproportionately affects men who have sex with men (MSM) and transgender women (TW). These populations use alcohol more heavily than the general population, and alcohol use disorders (AUDs) are more prevalent among them. Naltrexone (NTX) has documented efficacy and safety as a medication-assisted therapy for AUD. Its use has not been well-examined in persons with HIV (PWH) newly initiating antiretroviral therapy (ART) where the possibility of hepatotoxicity may be increased when initating multiple new medications. This study assessed the safety of oral NTX treatment (50 mg daily) initiated concomitantly with antiretroviral therapy (ART) in a double-blind randomized placebo-controlled trial of NTX in MSM/TW in Lima, Peru among MSM and TW with AUD (AUDIT score ≥ 8). We analyzed adverse event data from ART-naïve participants (N = 155) who were randomized (2:1) to initiate ART plus NTX (N = 103) or ART plus placebo (N = 52). Participants were monitored for 24 weeks while taking ART plus NTX/placebo, followed by 24 weeks receiving ART alone. Over 48 weeks, 135 grade 2 or 3 adverse events were reported, resulting in 1.3 clinical adverse events per participant equally represented in both treatment and placebo arms. Two serious adverse events occurred among two participants receiving NTX; neither was attributed to the study medication. No significant differences were found in the proportion of subjects reporting any adverse events between treatment arms across all time-points. These results suggest NTX is safe in MSM/TW PWH with AUD newly initiating ART, as no excess of clinical adverse events or transaminase elevation was associated with NTX use.",2020,No significant differences were found in the proportion of subjects reporting any adverse events between treatment arms across all time-points.,"['HIV-positive men who have sex with men and transgender women with alcohol use disorder and initiating antiretroviral therapy', 'persons with HIV (PWH) newly initiating antiretroviral therapy (ART', 'HIV disproportionately affects men who have sex with men (MSM) and transgender women (TW', 'ART-naïve participants (N = 155) who were randomized (2:1) to']","['oral naltrexone', 'NTX', 'placebo', 'ART plus placebo', 'initiate ART plus NTX', 'Naltrexone (NTX', 'ART plus NTX/placebo', 'oral NTX treatment (50 mg daily) initiated concomitantly with antiretroviral therapy (ART']","['proportion of subjects reporting any adverse events', 'adverse events']","[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",155.0,0.257235,No significant differences were found in the proportion of subjects reporting any adverse events between treatment arms across all time-points.,"[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gonzales', 'Affiliation': 'Asociación Civil Impacta Salud y Educación, Lima, Peru.'}, {'ForeName': 'Arielle', 'Initials': 'A', 'LastName': 'Grieco', 'Affiliation': 'University of Illinois at Chicago, School of Public Health, Chicago, IL, United States of America.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'White', 'Affiliation': 'Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Ding', 'Affiliation': 'University of Washington, School of Medicine, Seattle, WA, United States of America.'}, {'ForeName': 'Rachel Bender', 'Initials': 'RB', 'LastName': 'Ignacio', 'Affiliation': 'Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Pinto-Santini', 'Affiliation': 'Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Javier R', 'Initials': 'JR', 'LastName': 'Lama', 'Affiliation': 'Asociación Civil Impacta Salud y Educación, Lima, Peru.'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Altice', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, CT, United States of America.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Duerr', 'Affiliation': 'Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}]",PloS one,['10.1371/journal.pone.0228433']
454,31999300,Visual Field Changes Over 5 Years in Patients Treated With Panretinal Photocoagulation or Ranibizumab for Proliferative Diabetic Retinopathy.,"Importance
Preservation of peripheral visual field (VF) is considered an advantage for anti-vascular endothelial growth factor agents compared with panretinal photocoagulation (PRP) for treatment of proliferative diabetic retinopathy. Long-term data on VF are important when considering either treatment approach.
Objective
To further evaluate changes in VF throughout 5 years among eyes enrolled in the Protocol S clinical trial, conducted by the DRCR Retina Network.
Design, Setting, and Participants
Post hoc analyses of an ancillary study within a multicenter (55 US sites) randomized clinical trial. Individuals with eyes with proliferative diabetic retinopathy enrolled in Protocol S were included. Data were collected from February 2012 to February 2018. Analysis began in June 2018.
Interventions
Panretinal photocoagulation or intravitreous injections of 0.5-mg ranibizumab. Diabetic macular edema, whenever present, was treated with ranibizumab in both groups. Panretinal photocoagulation could be administered to eyes in the ranibizumab group when failure or futility criteria were met.
Main Outcomes and Measures
Mean change in total point score on VF testing with the Humphrey Field Analyzer 30-2 and 60-4 test patterns.
Results
Of 394 eyes enrolled in Protocol S, 234 (59.4%) were targeted for this ancillary study. Of these, 167 (71.4%) had VF meeting acceptable quality criteria at baseline (median [interquartile range] age, 50 [43-58] years; 90 men [53.9%]). At 5 years, 79 (33.8%) had results available. The mean (SD) change in total point score in the PRP and ranibizumab groups was -305 (521) dB and -36 (486) dB at 1 year, respectively, increasing to -527 (635) dB and -330 (645) dB at 5 years, respectively (P = .04). After censoring VF results after PRP treatments in the ranibizumab group, the 5-year mean change in total point score was -201 (442) dB. In a longitudinal regression analysis of change in total point score including both treatment groups, laser treatment was associated with a mean point decrease of 208 (95% CI, 112-304) dB for the initial PRP session, 77 (95% CI, 21-132) dB for additional PRP sessions, and 325 (95% CI, 211-439) dB for endolaser. No association was found between change in point score and the number of ranibizumab injections during the previous year (-9 per injection [95% CI, -22 to 3]).
Conclusions and Relevance
The limited data available from Protocol S suggest that there are factors besides PRP associated with VF loss in eyes treated for proliferative diabetic retinopathy. Further clinical research is warranted to clarify the finding.
Trial Registration
ClinicalTrials.gov identifier: NCT01489189.",2020,"No association was found between change in point score and the number of ranibizumab injections during the previous year (-9 per injection [95% CI, -22 to 3]).
","['Proliferative Diabetic Retinopathy', '394 eyes enrolled in Protocol S, 234 (59.4%) were targeted for this ancillary study', 'Individuals with eyes with proliferative diabetic retinopathy enrolled in Protocol S were included', 'Data were collected from February 2012 to February 2018']","['Panretinal photocoagulation', 'panretinal photocoagulation (PRP', 'Panretinal Photocoagulation or Ranibizumab', 'Panretinal photocoagulation or intravitreous injections of 0.5-mg ranibizumab', 'ranibizumab', 'peripheral visual field (VF']","['total point score', 'mean (SD) change in total point score', 'Visual Field Changes', 'Main Outcomes and Measures\n\n\nMean change in total point score on VF testing', '5-year mean change in total point score', 'Diabetic macular edema']","[{'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0730064', 'cui_str': 'Scatter retinal laser photocoagulation'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}]",,0.0737913,"No association was found between change in point score and the number of ranibizumab injections during the previous year (-9 per injection [95% CI, -22 to 3]).
","[{'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Johnson', 'Affiliation': 'Visual Field Reading Center, University of Iowa, Iowa City.'}, {'ForeName': 'Carl W', 'Initials': 'CW', 'LastName': 'Baker', 'Affiliation': 'Paducah Retinal Center, Paducah, Kentucky.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Gardner', 'Affiliation': 'Kellogg Eye Center, University of Michigan, Ann Arbor.'}, {'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Pieramici', 'Affiliation': 'California Retina Consultants, Santa Barbara.'}, {'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Stockdale', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Beetham Eye Institute, Joslin Diabetes Center, Department of Ophthalmology, Harvard, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.5939']
455,31791824,"DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2).","BACKGROUND
DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A in clinical development. Phase 2 data have shown it offers a more prolonged duration of response than onabotulinumtoxinA.
OBJECTIVE
To further evaluate the efficacy, duration of response, and safety of 40 U DAXI compared with placebo in the treatment of glabellar lines.
METHODS
Two identical, multicenter, randomized, double-blind, placebo-controlled, phase 3 studies were performed (NCT03014622 and NCT03014635 on www.clinicaltrials.gov). Participants with moderate or severe glabellar lines were randomly assigned (2:1) to receive 40 U DAXI or placebo into the corrugator/procerus muscles. Glabellar line severity was assessed by investigators and participants for up to 36 weeks (≥24 weeks).
RESULTS
Among 609 participants enrolled (405 DAXI, 204 placebo), 92% completed. DAXI was significantly more effective than placebo in reducing glabellar line severity and maintained none or mild glabellar line severity for a median of 24.0 weeks. It was also generally well tolerated-treatment-related adverse effects were most commonly headache (6.4% vs 2.0%) and injection site pain (3.7% vs 3.9%).
LIMITATIONS
The study population was predominantly female and white and received only a single treatment.
CONCLUSIONS
DAXI offers a prolonged duration of response for glabellar line reduction and is well tolerated.",2020,DAXI was significantly more effective than placebo in reducing glabellar line severity and maintained none or mild glabellar line severity for a median of 24.0 weeks.,"['609 participants enrolled (405 DAXI, 204 placebo), 92% completed', 'Participants with moderate or severe glabellar lines', 'study population was predominantly female and white and received only a single treatment']","['placebo', '40 U DAXI or placebo', 'DaxibotulinumtoxinA for Injection (DAXI', 'DaxibotulinumtoxinA']","['efficacy, duration of response, and safety', 'glabellar line severity and maintained none or mild glabellar line severity', 'Glabellar line severity', 'tolerated-treatment-related adverse effects', 'injection site pain']","[{'cui': 'C4517768', 'cui_str': 'Four hundred and five'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0442019', 'cui_str': 'Glabellar (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442019', 'cui_str': 'Glabellar (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}]",609.0,0.672154,DAXI was significantly more effective than placebo in reducing glabellar line severity and maintained none or mild glabellar line severity for a median of 24.0 weeks.,"[{'ForeName': 'Vince', 'Initials': 'V', 'LastName': 'Bertucci', 'Affiliation': 'Division of Dermatology, University of Toronto, Toronto, Ontario, Canada; private practice, Woodbridge, Ontario, Canada. Electronic address: vince.bertucci@utoronto.ca.'}, {'ForeName': 'Nowell', 'Initials': 'N', 'LastName': 'Solish', 'Affiliation': 'Division of Dermatology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Joely', 'Initials': 'J', 'LastName': 'Kaufman-Janette', 'Affiliation': 'Skin Associates of South Florida, Coral Gables, and Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Coral Gables, California.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Yoelin', 'Affiliation': 'private practice, Newport Beach, California.'}, {'ForeName': 'Ava', 'Initials': 'A', 'LastName': 'Shamban', 'Affiliation': 'private practice, Santa Monica, California.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Schlessinger', 'Affiliation': 'Skin Specialists PC, Omaha, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Snyder', 'Affiliation': 'Revance Therapeutics, Inc, Newark, California.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Gallagher', 'Affiliation': 'Revance Therapeutics, Inc, Newark, California.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Revance Therapeutics, Inc, Newark, California.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Shears', 'Affiliation': 'Write on Target Ltd, Leighton Buzzard, United Kingdom.'}, {'ForeName': 'Roman G', 'Initials': 'RG', 'LastName': 'Rubio', 'Affiliation': 'Revance Therapeutics, Inc, Newark, California.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.06.1313']
456,31809827,Maintenance of clinical response and consistent safety profile with up to 3 years of continuous treatment with guselkumab: Results from the VOYAGE 1 and VOYAGE 2 trials.,"BACKGROUND
Long-term maintenance treatment is required for patients with psoriasis.
OBJECTIVES
To evaluate the efficacy and safety of guselkumab in patients with moderate to severe psoriasis through 3 years of treatment.
METHODS
In 2 ongoing, phase 3 trials of guselkumab (VOYAGE 1 and VOYAGE 2), the proportions of patients achieving at least 90% and 100% improvement in the Psoriasis Area and Severity Index (PASI 90 and PASI 100, respectively) and Investigator's Global Assessment (IGA) scores of 0/1 and 0 were summarized for the guselkumab group (including placebo-to-guselkumab crossover). Patients who met treatment failure rules were considered nonresponders. Safety outcomes (rates/100 patient-years [PY]) were evaluated based on data pooled across studies through week 156.
RESULTS
Three-year response rates for the guselkumab group in VOYAGE 1 and VOYAGE 2, respectively, were 82.8% and 77.2% for PASI 90, 50.8% and 48.8% for PASI 100, 82.1% and 83.0% for IGA score of 0/1, and 53.1% and 52.9% for IGA score of 0. Safety event rates across studies occurred through week 156 as follows: serious adverse events, 5.68/100 PY; serious infections, 1.15/100 PY; nonmelanoma skin cancers, 0.28/100 PY; malignancies other than nonmelanoma skin cancer, 0.47/100 PY; and major adverse cardiovascular events, 0.28/100 PY. Week 156 and week 100 rates were consistent.
LIMITATIONS
There was no comparator arm beyond 1 year.
CONCLUSIONS
Guselkumab shows durable efficacy and a consistent safety profile in patients with moderate to severe psoriasis treated for up to 3 years.",2020,"Safety event rates across studies occurred through week 156 as follows: serious adverse events, 5.68/100 PY; serious infections, 1.15/100 PY; nonmelanoma skin cancers, 0.28/100 PY; malignancies other than nonmelanoma skin cancer, 0.47/100","['patients with moderate to severe psoriasis through 3\xa0years of treatment', 'patients with psoriasis', 'patients with moderate to severe psoriasis treated for up to 3\xa0years']",['guselkumab'],"['response rates', ""Psoriasis Area and Severity Index (PASI 90 and PASI 100, respectively) and Investigator's Global Assessment (IGA) scores"", 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0711524,"Safety event rates across studies occurred through week 156 as follows: serious adverse events, 5.68/100 PY; serious infections, 1.15/100 PY; nonmelanoma skin cancers, 0.28/100 PY; malignancies other than nonmelanoma skin cancer, 0.47/100","[{'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation Center, Hamburg, Germany. Electronic address: kreich@jerucon.com.'}, {'ForeName': 'Christopher E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester NIHR Biomedical Research Centre, Manchester, United Kingdom.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'K Papp Clinical Research and Probity Research, Inc, Waterloo, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Randazzo', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania; Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Yaung-Kaung', 'Initials': 'YK', 'LastName': 'Shen', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Alexa B', 'Initials': 'AB', 'LastName': 'Kimball', 'Affiliation': 'Department of Dermatology, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ""The University of Melbourne, St. Vincent's Hospital Melbourne and Probity Medical Research, Skin & Cancer Foundation Inc., Carlton, Victoria, Australia.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, Oregon.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.11.040']
457,32045077,A randomized controlled trial of a Group psychological intervention to increase locus of control for alcohol consumption among Alcohol-Misusing Short-term (male) Prisoners (GASP).,"BACKGROUND AND AIM
Reducing alcohol misuse by male prisoners is an important global issue. Control of drinking behaviour could be a useful target for intervention in this population, and locus of control could be a causal factor in this. We aimed to assess the effect of a clinical psychologist-facilitated group intervention on male prisoners' locus of control of drinking behaviour.
DESIGN
A two-arm, single-site, open, randomized controlled trial.
SETTING
A category B local training prison in South Wales, housing about 770 mainly sentenced men.
PARTICIPANTS
Prisoners serving less than 2 years who met inclusion criteria for pre-imprisonment alcohol misuse, alone or with drug misuse. A total of 119 were allocated to the intervention arm and 119 to the control arm; 104 and 87, respectively, completed the post-randomization baseline interview and 68 and 60 completed a second interview approximately 4 weeks later, respectively, after intervention or treatment as usual (TAU) alone.
INTERVENTION
Nine clinical psychologist-facilitated groups in the prison over 3 weeks. Range of participants per session was one to seven, with three to five most usual.
MEASURES
The primary outcome was locus of control of behaviour (LCB); secondary outcomes included mental state generally (comprehensive psychiatric rating scale/CPRS) and specifically (Beck Depression Inventory/BDI). An integral process evaluation was conducted.
FINDINGS
LCB scores decreased during the study, but without significant intervention effect [-1.7, 95% confidence interval (CI) = -5.1 to 1.6, P = 0.329]. Change among completers in the control group was from a mean score of 37.4 [standard deviation (SD) = 10.0] to 33.7[SD = 11.7] and in the intervention group from 37.4 (SD = 11.6) to 31.9 (SD = 11.8). Secondary outcomes, including change in mental state, did not differ between arms, but 686 (64%) sessions were lost, most because of 'prison issues'.
CONCLUSIONS
A clinical psychologist-facilitated group intervention did not have a statistically significant effect on sense of control of drinking behaviour among men with pre-imprisonment alcohol misuse serving less than 2 years in a South Wales prison. The study proved coterminous, however, with 40% prison staff cuts which seem likely to have contributed to the high loss of group sessions and possibly overwhelmed any treatment effect. Intervention completion failures, previously cited as harmful, had no effect here, so the trial should be repeated when the prison climate improves.",2020,"CONCLUSIONS
A clinical psychologist-facilitated group intervention did not have a statistically significant effect on sense of control of drinking behaviour among men with pre-imprisonment alcohol misuse serving under two years in a South Wales prison.","['Prisoners serving under two years who met inclusion criteria for pre-imprisonment alcohol misuse, alone or with drug misuse', 'A total of 119 were allocated to the intervention arm and 119 to the control arm; 104 and 87 respectively completed the', 'men with pre-imprisonment alcohol misuse serving under two years in a South Wales prison', ""male prisoners' locus of control of drinking behaviour"", 'male prisoners', 'Alcohol-misusing Short-term (male) Prisoners (GASP', 'A category B, local training prison in South Wales, housing nearly 800 mostly sentenced men']","['Group psychological intervention', 'post-randomisation baseline interview and 68 and 60 completed a second interview about 4 weeks later, respectively after intervention or treatment as usual (TAU) alone', 'clinical psychologist-facilitated group intervention']","['change in mental state', 'LCB scores', 'sense of control of drinking behaviour', 'Locus of Control of Behaviour (LCB); secondary outcomes included mental state generally (Comprehensive Psychiatric Rating Scale/CPRS) and specifically (Beck Depression Inventory/BDI']","[{'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205255', 'cui_str': 'Imprisonment (finding)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C4476470', 'cui_str': 'Drug Misuse'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0023953', 'cui_str': 'Locus of Control'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237412', 'cui_str': 'Clinical psychologist (occupation)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021783', 'cui_str': 'Sense of Control'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0023953', 'cui_str': 'Locus of Control'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}]",,0.109688,"CONCLUSIONS
A clinical psychologist-facilitated group intervention did not have a statistically significant effect on sense of control of drinking behaviour among men with pre-imprisonment alcohol misuse serving under two years in a South Wales prison.","[{'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Taylor', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Playle', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Bezeczky', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'John-Evans', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Polyxeni', 'Initials': 'P', 'LastName': 'Dimitropoulou', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'McNamara', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Moriarty', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Zelda', 'Initials': 'Z', 'LastName': 'Summers', 'Affiliation': 'Abertawe Bro Morgannwg University Health Board, Port Talbot, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bagshaw', 'Affiliation': 'Abertawe Bro Morgannwg University Health Board, Port Talbot, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.15006']
458,32102946,Vitamin D Pathway and Other Related Polymorphisms and Risk of Prostate Cancer: Results from the Prostate Cancer Prevention Trial.,"Vitamin D may influence prostate cancer risk, but evidence is inconsistent. We conducted a nested case-control study in the Prostate Cancer Prevention Trial (PCPT). Cases ( n = 1,128) and controls ( n = 1,205) were frequency matched on age, first-degree relative with prostate cancer, and PCPT treatment arm (finasteride/placebo); African-Americans were oversampled and case/control status was biopsy confirmed. We selected 21 SNPs in vitamin D-related genes (VDR, GC, C10orf88, CYP2R1, CYP24A1, CYP27B1, DHCR7 , and NADSYN1 ) to test genotype and genotype-treatment interactions in relation to prostate cancer. We also tested mean serum 25(OH)D differences by minor allele distributions and tested for serum 25(OH)D-genotype interactions in relation to prostate cancer risk. Log-additive genetic models (Bonferroni-corrected within genes) adjusted for age, body mass index, PSA, and family history of prostate cancer revealed a significant interaction between treatment arm and GC /rs222016 (finasteride OR = 1.37, placebo OR = 0.85; P interaction < 0.05), GC /rs222014 (finasteride OR = 1.36, placebo OR = 0.85; P interaction < 0.05), and CYP27B1 /rs703842 (finasteride OR = 0.76, placebo OR = 1.10; P interaction < 0.05) among Caucasians, and C10orf88 /rs6599638 (finasteride OR = 4.68, placebo OR = 1.39; P interaction < 0.05) among African-Americans. VDR/ rs1544410 and CYP27B1 /rs703842 had significant treatment interactions for high-grade disease among Caucasians (finasteride OR = 0.81, placebo OR = 1.40; P interaction < 0.05 and finasteride OR = 0.70, placebo OR = 1.28; P interaction < 0.05, respectively). Vitamin D-related SNPs influenced serum 25(OH)D, but gene-serum 25(OH)D effect modification for prostate cancer was marginally observed only for CYP24A1 /rs2248359. In conclusion, evidence that vitamin D-related genes or gene-serum 25(OH)D associations influence prostate cancer risk is modest. We found some evidence for gene-finasteride interaction effects for prostate cancer in Caucasians and African-Americans. Results suggest only minimal associations of vitamin D with total or high-grade prostate cancer.",2020,"finasteride OR=4.68, placebo OR=1.39, p-interaction<0.05) among African Americans.","['Cases (n=1,128) and controls (n=1,205) were frequency matched on age, first-degree relative with prostate cancer and', 'African-Americans were oversampled and', 'prostate cancer in Caucasians and African-Americans', 'African Americans']","['placebo', 'Vitamin D-related SNPs', 'PCPT treatment arm (finasteride/placebo', 'Vitamin D', 'finasteride', 'CYP27B1/rs703842 (finasteride OR=0.76, placebo', 'GC/rs222014 (finasteride']",[],"[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0060389', 'cui_str': 'Finasteride'}, {'cui': 'C0000340', 'cui_str': '25-Hydroxyvitamin D2 1-hydroxylase'}]",[],1205.0,0.071002,"finasteride OR=4.68, placebo OR=1.39, p-interaction<0.05) among African Americans.","[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Torkko', 'Affiliation': 'Department of Pathology, University of Colorado, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Cathee', 'Initials': 'C', 'LastName': 'Till', 'Affiliation': 'Division of Public Health Sciences, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'Division of Public Health Sciences, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Phyllis J', 'Initials': 'PJ', 'LastName': 'Goodman', 'Affiliation': 'Division of Public Health Sciences, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Jeannette M', 'Initials': 'JM', 'LastName': 'Schenk', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Lucia', 'Affiliation': 'Department of Pathology, University of Colorado, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Peters', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Adrie', 'Initials': 'A', 'LastName': 'van Bokhoven', 'Affiliation': 'Department of Pathology, University of Colorado, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'Christus Santa Rosa Hospital-Medical Center, San Antonio, Texas.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington. mneuhous@fredhutch.org.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0413']
459,32157582,"Level of pain, muscle strength and posture: effects of PBM on an exercise program in women with knee osteoarthritis - a randomized controlled trial.","To evaluate the effectiveness of an exercise program associated to photobiomodulation (PBM) on pain, postural changes, functionally, and muscular strength in women, one of the risk factors, with knee osteoarthritis (OA). A randomized controlled trial, with a blinded assessor and intention-to-treat analysis and placebo control. Sixty-two participants with knee OA (with confirmed radiological diagnosis) were evaluated for this study. However, 34 were considered eligible and were randomized into two groups: EPPG - exercise and PBM placebo group (n = 17) and EPAG - exercise and PBM active group (n = 16), but one participant was excluded of EPAG. The exercise program and PBM (808 nm, 100 mW/point, 4 J/point, 56 J total, 91 J/cm 2 ) were realized twice a week, during 8 weeks. West Ontario and the McMaster University Osteoarthritis Index (WOMAC) and Lequesne questionnaires, 1-repetition maximum test (1-RM) and posture evaluation software (SAPO) were used to analyze the effects of the therapies. In intragroup analysis, a significant improvement in pain WOMAC (p < 0.001), stiffness (p < 0.001), function (p < 0.001), Lequesne (p < 0.001), and 1-RM (all muscle groups) (p < 0.001) were observed. In this study, the exercise program improved pain, function, and muscle strength of all the participants. However, PBM, in the parameters used, did not optimize the effects of the exercise program in women with knee OA.",2020,"In intragroup analysis, a significant improvement in pain WOMAC (p < 0.001), stiffness (p < 0.001), function (","['women, one of the risk factors, with knee osteoarthritis (OA', 'women with knee OA', 'women with knee osteoarthritis ', 'Sixty-two participants with knee OA (with confirmed radiological diagnosis']","['EPPG - exercise and PBM placebo', 'exercise program', 'exercise program associated to photobiomodulation (PBM', 'PBM', 'EPAG - exercise and PBM active group', 'placebo control', 'exercise program and PBM']","['pain WOMAC', 'McMaster University Osteoarthritis Index (WOMAC) and Lequesne questionnaires, 1-repetition maximum test (1-RM) and posture evaluation software (SAPO', '1-RM', 'pain, postural changes, functionally, and muscular strength', 'Level of pain, muscle strength and posture: effects', 'pain, function, and muscle strength']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",62.0,0.0824289,"In intragroup analysis, a significant improvement in pain WOMAC (p < 0.001), stiffness (p < 0.001), function (","[{'ForeName': 'Patricia Gabrielli', 'Initials': 'PG', 'LastName': 'Vassão', 'Affiliation': 'Department of Biosciences, Federal University of São Paulo, Campus Baixada Santista, Rua Silva Jardim, 136, Santos, SP, 11015-020, Brazil. patriciavassao@gmail.com.'}, {'ForeName': 'Bruna Arcaim', 'Initials': 'BA', 'LastName': 'Silva', 'Affiliation': 'Department of Biosciences, Federal University of São Paulo, Campus Baixada Santista, Rua Silva Jardim, 136, Santos, SP, 11015-020, Brazil.'}, {'ForeName': 'Mayra Cavenague', 'Initials': 'MC', 'LastName': 'de Souza', 'Affiliation': 'Department of Biosciences, Federal University of São Paulo, Campus Baixada Santista, Rua Silva Jardim, 136, Santos, SP, 11015-020, Brazil.'}, {'ForeName': 'Julia Risso', 'Initials': 'JR', 'LastName': 'Parisi', 'Affiliation': 'Department of Physiotherapy, Federal University of São Carlos (UFSCar), São Carlos, SP, Brazil.'}, {'ForeName': 'Marcela Regina', 'Initials': 'MR', 'LastName': 'de Camargo', 'Affiliation': 'Department of Biosciences, Federal University of São Paulo, Campus Baixada Santista, Rua Silva Jardim, 136, Santos, SP, 11015-020, Brazil.'}, {'ForeName': 'Ana Claudia Muniz', 'Initials': 'ACM', 'LastName': 'Renno', 'Affiliation': 'Department of Biosciences, Federal University of São Paulo, Campus Baixada Santista, Rua Silva Jardim, 136, Santos, SP, 11015-020, Brazil.'}]",Lasers in medical science,['10.1007/s10103-020-02989-1']
460,32077909,Long-term Effect of Intraocular Lens vs Contact Lens Correction on Visual Acuity After Cataract Surgery During Infancy: A Randomized Clinical Trial.,"Importance
Although intraocular lenses (IOLs) are often implanted in children, little is known whether primary IOL implantation or aphakia and contact lens correction results in better long-term visual outcomes after unilateral cataract surgery during infancy.
Objective
To compare long-term visual outcomes with contact lens vs IOL correction following unilateral cataract surgery during infancy.
Design, Setting, and Participants
This multicenter randomized clinical trial enrolled 114 infants with a unilateral congenital cataract who underwent cataract surgery with or without primary IOL implantation between 1 and 6 months of age. Data on long-term visual outcomes were collected when the children were age 10.5 years (July 14, 2015, to July 12, 2019) and analyzed from March 30 through August 6, 2019.
Interventions
Intraocular lens implantation at the time of cataract surgery.
Main Outcomes and Measures
Best-corrected visual acuity using the electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) testing protocol. Analysis was performed on an intention-to-treat basis.
Results
Best-corrected visual acuity was measured at age 10.5 years for 110 of the 114 patients (96%) enrolled as infants. The participants included 58 girls (53%) and 52 boys (47%). Overall, 27 of the children (25%) had good (logMAR 0.30 [Snellen equivalent, 20/40] or better) visual acuity in the treated eye (12 [22%] in the IOL group and 15 [27%] in the aphakia group), but 50 children (44%) had a visual acuity of logMAR 1.00 (Snellen equivalent, 20/200) or worse (25 [44%] in the IOL group and 25 [44%] in the aphakia group). The median logMAR acuity in the treated eye was similar in children randomized to receive an IOL at the time of cataract extraction (0.89; interquartile range [IQR], 0.33-1.43 [Snellen equivalent, 20/159]) and those who remained aphakic (0.86; IQR, 0.30-1.46 [Snellen equivalent, 20/145]) (IQR, 0.30-1.46; P = .82). Although the overall difference in median visual acuity between the 2 groups was small, the estimate was imprecise (99% CI for the difference in medians was -0.54 to 0.47).
Conclusions and Relevance
As in previous phases of the study, visual acuity outcomes were highly variable with only 27 children (25%) achieving excellent visual acuity in their treated eye and 50 children (44%) having poor vision in the treated eye. Implanting an IOL at the time of cataract extraction was neither beneficial nor detrimental to the visual outcome.
Trial Registration
ClinicalTrials.gov Identifier: NCT00212134.",2020,"Overall, 27 of the children (25%) had good (logMAR 0.30","['participants included 58 girls (53%) and 52 boys (47', 'children were age 10.5 years (July 14, 2015, to July 12, 2019) and analyzed from March 30 through August 6, 2019', '114 infants with a unilateral congenital cataract who underwent cataract surgery with or without primary IOL implantation between 1 and 6 months of age', 'unilateral cataract surgery during infancy']","['contact lens vs IOL correction', 'Intraocular Lens vs Contact Lens Correction', 'Cataract Surgery', 'intraocular lenses (IOLs', 'Interventions\n\n\nIntraocular lens implantation']","['Results\n\n\nBest-corrected visual acuity', 'excellent visual acuity', 'Visual Acuity', 'median logMAR acuity', 'Main Outcomes and Measures\n\n\nBest-corrected visual acuity using the electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) testing protocol', 'visual acuity outcomes', 'visual acuity of logMAR', 'median visual acuity', 'better) visual acuity']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0009691', 'cui_str': 'Congenital cataract (disorder)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0521706', 'cui_str': 'Unilateral cataract'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0231330', 'cui_str': 'Infancy - period'}]","[{'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0023311', 'cui_str': 'Lens Implantation, Intraocular'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}]",114.0,0.530132,"Overall, 27 of the children (25%) had good (logMAR 0.30","[{'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Lambert', 'Affiliation': 'Department of Ophthalmology, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Cotsonis', 'Affiliation': 'Rollins School of Public Health, Department of Biostatistics and Bioinformatics, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Lindreth', 'Initials': 'L', 'LastName': 'DuBois', 'Affiliation': 'Department of Ophthalmology, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Azhar', 'Initials': 'A', 'LastName': 'Nizam Ms', 'Affiliation': 'Rollins School of Public Health, Department of Biostatistics and Bioinformatics, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Stacey J', 'Initials': 'SJ', 'LastName': 'Kruger', 'Affiliation': 'Department of Ophthalmology, Northwell Health, Great Neck, New York.'}, {'ForeName': 'E Eugenie', 'Initials': 'EE', 'LastName': 'Hartmann', 'Affiliation': ""Rebecca D. Considine Research Institute and Vision Center, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Weakley', 'Affiliation': 'Department of Ophthalmology, University of Texas, Southwestern Medical Center, Dallas.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Drews-Botsch', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.0006']
461,31873950,2b or not 2b? Shoulder function after level 2b neck dissection: A double-blind randomized controlled clinical trial.,"BACKGROUND
Selective neck dissection (SND) is a mainstay of head and neck cancer treatment. A common sequela is shoulder syndrome from spinal accessory nerve (SAN) trauma. Extensive dissection in neck levels 2 and 5 leads to SAN dysfunction. However, it is not known whether limited level 2 dissection reduces SAN injury. The purpose of this double-blind randomized controlled trial was to determine whether omitting level 2b dissection would improve shoulder-related quality of life and function.
METHODS
Patients with head and neck cancers undergoing surgery were randomized 1:1 to SND without level 2b dissection (group 1) or with it (group 2) on their dominant-hand side. Patients, caregivers, and assessors were blinded. The primary outcome was the change in the Neck Dissection Impairment Index (NDII) score after 6 months. An a priori calculation of the minimally important clinical difference in the NDII score was determined to establish a sample size of 15 patients per group (power = 0.8). Secondary outcomes included shoulder strength and range of motion (ROM) and SAN nerve conduction. The trial was registered at ClinicalTrials.gov (NCT00765791).
RESULTS
Forty patients were enrolled, and 30 were included (15 per group). Six months after the surgery, group 2 demonstrated a significant median decrease in the NDII from the baseline (30 points) and in comparison with group 1, whose NDII dropped 17.5 points (P = .02). Shoulder ROM and SAN conduction demonstrated significant declines in group 2 (P ≤ .05). No adverse events occurred.
CONCLUSIONS
Level 2b should be omitted in SND when this is oncologically safe and feasible. This allows for an optimal balance between function and cancer cure.",2020,Shoulder ROM and SAN conduction demonstrated significant declines in group 2 (P ≤ .05).,"['Forty patients were enrolled, and 30 were included (15 per group', 'Shoulder function after level 2b neck dissection', 'Patients with head and neck cancers undergoing surgery']","['SND without level 2b dissection (group 1) or with it (group 2) on their dominant-hand side', 'Selective neck dissection (SND']","['shoulder strength and range of motion (ROM) and SAN nerve conduction', 'change in the Neck Dissection Impairment Index (NDII) score', 'NDII', 'Shoulder ROM and SAN conduction', 'shoulder-related quality of life and function', 'adverse events', 'NDII score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0398395', 'cui_str': 'Neck Dissection'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0449722', 'cui_str': 'Dominant hand (attribute)'}, {'cui': 'C0441987', 'cui_str': 'Side (qualifier value)'}, {'cui': 'C0398397', 'cui_str': 'Selective neck dissection of cervical lymph nodes (procedure)'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0027788', 'cui_str': 'Nerve Conduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0398395', 'cui_str': 'Neck Dissection'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",40.0,0.647647,Shoulder ROM and SAN conduction demonstrated significant declines in group 2 (P ≤ .05).,"[{'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Dziegielewski', 'Affiliation': 'Department of Otolaryngology, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'McNeely', 'Affiliation': 'Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Ashworth', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': ""O'Connell"", 'Affiliation': 'Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Barber', 'Affiliation': 'Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kerry S', 'Initials': 'KS', 'LastName': 'Courneya', 'Affiliation': 'Faculty of Physical Education and Recreation, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Brock J', 'Initials': 'BJ', 'LastName': 'Debenham', 'Affiliation': 'Department of Radiation Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Seikaly', 'Affiliation': 'Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.'}]",Cancer,['10.1002/cncr.32681']
462,32162321,Use of an intraoperative wound protector to prevent surgical-site infection after pancreatoduodenectomy: randomized clinical trial.,"BACKGROUND
Surgical-site infection (SSI) increases treatment costs, duration of hospital stay and readmission rate after pancreatic surgery. This study aimed to assess whether a wound protector could reduce the risk of superficial incisional SSI after pancreatoduodenectomy.
METHODS
This RCT included patients undergoing pancreatoduodenectomy at Verona University Hospital, between 2017 and 2018. The experimental group had a dual-ring wound protector, whereas the control group had standard surgical drapes. The groups were stratified by preoperative biliary stent placement. The primary outcome was the overall rate of superficial SSI.
RESULTS
An interim analysis was conducted after 212 patients had been enrolled; 22 patients (10·4 per cent) were excluded owing to inability to complete the pancreatoduodenectomy, or the need for postoperative reintervention. Some 94 patients (49·5 per cent) had a wound protector and 96 (50·5 per cent) had standard drapes. There were no differences between groups in demographics, or in intraoperative findings, pathological data or surgical outcomes. The overall superficial SSI rate was 7·4 per cent, which did not differ between groups (7 per cent in each group; P = 0·585). Subanalysis of patients with a preoperative biliary stent showed a similar outcome (superficial SSI rate 9 versus 8 per cent with wound protector versus surgical drapes respectively; P = 0·536). The trial was stopped prematurely on the grounds of futility.
CONCLUSION
Use of a wound protector did not reduce the rate of superficial SSI after pancreatoduodenectomy. Registration number: NCT03820648 (http://www.clinicaltrials.gov).",2020,"The overall superficial SSI rate was 7·4 per cent, which did not differ between groups (7 per cent in each group; P = 0·585).","['patients undergoing pancreatoduodenectomy at Verona University Hospital, between 2017 and 2018', '212 patients had been enrolled; 22 patients (10·4 per cent) were excluded owing to inability to complete the pancreatoduodenectomy, or the need for postoperative reintervention', 'after pancreatic surgery']","['preoperative biliary stent placement', 'intraoperative wound protector', 'dual-ring wound protector', 'control group had standard surgical drapes', 'wound protector']","['treatment costs, duration of hospital stay and readmission rate', 'overall superficial SSI rate', 'similar outcome (superficial SSI rate', 'rate of superficial SSI', 'risk of superficial incisional SSI', 'overall rate of superficial SSI', 'intraoperative findings, pathological data or surgical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0562018', 'cui_str': 'cent (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0183512', 'cui_str': 'Biliary stent (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0180511', 'cui_str': 'Surgical Drapes'}]","[{'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",,0.26657,"The overall superficial SSI rate was 7·4 per cent, which did not differ between groups (7 per cent in each group; P = 0·585).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Pastena', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Marchegiani', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Paiella', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fontana', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Esposito', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Casetti', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Secchettin', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Manzini', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bassi', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Salvia', 'Affiliation': 'Department of General and Pancreatic Surgery, Pancreas Institute, University and Hospital Trust of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro, 10, 37134, Verona, Italy.'}]",The British journal of surgery,['10.1002/bjs.11527']
463,32161942,A Pilot Randomized Clinical Trial of Brief Interventions to Encourage Quit Attempts in Smokers From Socioeconomic Disadvantage.,"INTRODUCTION
Cigarette smoking disproportionately affects communities of low socioeconomic status where greater smoking prevalence and poorer cessation rates have been observed. Utilizing brief evidence-based interventions to increase cessation attempts may be an effective and easily disseminable means by which to mitigate undue burden in this population.
AIMS AND METHODS
The current intervention randomized daily smokers (N = 57) recruited from a local community soup kitchen to receive either Brief (eg, 30 m) Motivational Interviewing, Nicotine Replacement Therapy (NRT) sampling, or a Referral-Only intervention. Approximately half of participants (50.9%) reported not completing high school and many reported either just (41.4%) or not (40.4%) meeting basic expenses. Follow-up was completed approximately 1-month postintervention.
RESULTS
Nonsignificant group differences indicated that participants randomized to the NRT sampling condition were more likely to make a quit attempt (moderate effect size). Approximately 40% of the sample reported making a serious quit attempt at follow-up. Significant differences in cigarettes per day at follow-up, controlling for baseline, were observed, with participants in the Motivational Interviewing condition, only, reporting significant reductions. Participants randomized to the NRT condition were significantly more likely to report using NRT patch and lozenge at follow-up (large effect). There were no differences between groups with respect to seeking behavioral support. Finally, we found that subjective financial strain moderated the effect of condition on change in cigarette consumption where NRT sampling was more effective for participants reporting less financial strain.
CONCLUSIONS
Findings provide initial evidence for personalizing brief interventions to promote quit attempts in low-income smokers.
IMPLICATIONS
While most clinical research on tobacco use and dependence focuses on successful sustained abstinence, the current study is novel because it examined three brief interventions designed to increase the number of quit attempts made by a nontreatment-seeking group suffering from health disparities (ie, smokers from socioeconomic disadvantage). These data suggest that nontreatment-seeking smokers from socioeconomic disadvantage can be influenced by Brief MIs and these interventions should be used to motivate smokers from socioeconomic disadvantage to make a quit attempt. Future studies should examine combined MIs including pharmacological and behavioral interventions.",2020,"RESULTS
Non-significant group differences indicated that participants randomized to the NRT sampling condition were more likely to make a quit attempt (moderate effect size).",[],"['local community soup kitchen to receive either brief (e.g., 30m) motivational interviewing, nicotine replacement therapy sampling, or a referral-only intervention']",[],[],"[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0453399', 'cui_str': 'Soup (substance)'}, {'cui': 'C0557653', 'cui_str': 'Kitchen (environment)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0034927', 'cui_str': 'Referral'}]",[],57.0,0.0266812,"RESULTS
Non-significant group differences indicated that participants randomized to the NRT sampling condition were more likely to make a quit attempt (moderate effect size).","[{'ForeName': 'Marc L', 'Initials': 'ML', 'LastName': 'Steinberg', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Department of Psychiatry, New Brunswick, NJ.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Rosen', 'Affiliation': 'Rutgers University, Department of Psychology, Piscataway, NJ.'}, {'ForeName': 'Mark V', 'Initials': 'MV', 'LastName': 'Versella', 'Affiliation': 'Rutgers University, Department of Psychology, Piscataway, NJ.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Borges', 'Affiliation': 'Rutgers University, Department of Psychology, Piscataway, NJ.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Leyro', 'Affiliation': 'Rutgers University, Department of Psychology, Piscataway, NJ.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa047']
464,32161992,Bifrontal transcranial direct current stimulation modulates fatigue in multiple sclerosis: a randomized sham-controlled study.,"Fatigue is a frequent and debilitating symptom in patients with central nervous system diseases. Up to 90% of patients with multiple sclerosis (MS) suffer from fatigue that drastically affects the quality of life. MS patients also complain of anxiety and depressive symptoms and these three manifestations tend to cluster together in this clinical population. The objective of this work was to assess the effects of transcranial direct stimulation (tDCS), a noninvasive brain stimulation technique, on fatigue as well as anxiety and depressive symptoms. Eleven fatigued MS patients randomly received two blocks (active and sham tDCS) of five consecutive daily sessions of bifrontal tDCS (anode/cathode over the left/right prefrontal cortices, respectively) in a crossover manner, separated by a 3-week washout interval. Evaluation took place at day 1, day 5 (right after each block) and 1 week later. Active but not sham tDCS resulted in a significant improvement of fatigue at day 5 (p < 0.05), an effect that seems to last at least 1 week following the stimulation (p = 0.05). Active tDCS also significantly improved anxiety symptoms, but the effect emerged 1 week later (p < 0.05). No significant effects were obtained regarding depression (p > 0.05). Bifrontal tDCS seems to modulate fatigue in PwMS. The observed anxiolytic effects could constitute delayed after effects of tDCS or might be mediated by fatigue improvement. These findings merit to be addressed in large-scale controlled trials.",2020,"Active but not sham tDCS resulted in a significant improvement of fatigue at day 5 (p < 0.05), an effect that seems to last at least 1 week following the stimulation (p = 0.05).","['Eleven fatigued MS patients randomly received', 'multiple sclerosis', 'patients with central nervous system diseases']","['two blocks (active and sham tDCS', 'tDCS', 'Bifrontal transcranial direct current stimulation', 'transcranial direct stimulation (tDCS']","['complain of anxiety and depressive symptoms', 'quality of life', 'anxiety symptoms', 'fatigue', 'anxiety and depressive symptoms']","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0007682', 'cui_str': 'CNS Diseases'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0445448', 'cui_str': 'Bifrontal (qualifier value)'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.0220744,"Active but not sham tDCS resulted in a significant improvement of fatigue at day 5 (p < 0.05), an effect that seems to last at least 1 week following the stimulation (p = 0.05).","[{'ForeName': 'Moussa A', 'Initials': 'MA', 'LastName': 'Chalah', 'Affiliation': 'EA 4391, Excitabilité Nerveuse et Thérapeutique, Université Paris-Est-Créteil, Créteil, France.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Grigorescu', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Kümpfel', 'Affiliation': 'Institute for Clinical Neuroimmunology, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Palm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Samar S', 'Initials': 'SS', 'LastName': 'Ayache', 'Affiliation': 'EA 4391, Excitabilité Nerveuse et Thérapeutique, Université Paris-Est-Créteil, Créteil, France. samarayache@gmail.com.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-020-02166-2']
465,32122325,Effects of simultaneous cognitive and aerobic exercise training on dual-task walking performance in healthy older adults: results from a pilot randomized controlled trial.,"BACKGROUND
The ability to walk and perform cognitive tasks simultaneously is a key aspect of daily life. Performance declines in these dual-tasks may be associated with early signs of neurodegenerative disease and increased risk of falls. Thus, interventions to improve dual-task walking performance are of great interest for promoting healthy aging. Here, we present results of a pilot randomized controlled trial (RCT) to evaluate the effects of a simultaneous aerobic exercise and cognitive training intervention on dual-task walking performance in healthy older adults.
METHODS
Community-dwelling, healthy older adults were recruited to participate in a 12-week RCT. Participants were randomized into one of four groups (n = 74): 1) cognitive training (COG), 2) aerobic exercise (EX), 3) combined aerobic exercise and cognitive training (EXCOG), and 4) video-watching control (CON). The COG and EXCOG groups both used a tablet-based cognitive training program that challenged aspects of executive cognitive function, memory, and processing speed. Performance on a dual-task walking test (DTWT; serial subtraction during two-minute walk) was assessed by researchers blinded to groupings before the intervention, and at 6 and 12 weeks. We included all participants randomized with baseline measurements in an intention to treat analysis using linear mixed effects models.
RESULTS
We found a significant group by time interaction for cognitive performance on the DTWT (p = 0.039). Specifically, participants in the EXCOG, EX, and COG groups significantly improved on the cognitive aspect of the DTWT following the full 12-week intervention (p = 3.5e-7, p = 0.048, p = 0.048, respectively). The improvements in EXCOG were twice as large as in the other groups, and were significant at 6 weeks (p = 0.019). The CON group did not show a significant change in cognitive performance on the DTWT, and no group significantly altered dual-task gait measures following the intervention.
CONCLUSIONS
A simultaneous aerobic exercise and cognitive training intervention significantly improved cognitive performance during a DTWT in healthy older adults. Despite no change in DTWT gait measures, significant improvements in cognitive performance indicate that further investigation in a larger RCT is warranted.
TRIAL REGISTRATION
Clinicaltrials.gov, NCT04120792, Retrospectively Registered 08 October 2019.",2020,We found a significant group by time interaction for cognitive performance on the DTWT (p = 0.039).,"['Community-dwelling, healthy older adults', 'healthy older adults']","['aerobic exercise and cognitive training intervention', 'simultaneous aerobic exercise and cognitive training intervention', 'cognitive training (COG), 2) aerobic exercise (EX), 3) combined aerobic exercise and cognitive training (EXCOG), and 4) video-watching control (CON', 'CON', 'simultaneous cognitive and aerobic exercise training', 'dual-task walking test (DTWT; serial subtraction during two-minute walk']","['cognitive performance', 'dual-task walking performance', 'cognitive aspect', 'dual-task gait measures', 'executive cognitive function, memory, and processing speed', 'EXCOG', 'time interaction for cognitive performance']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0243151', 'cui_str': 'cognitive aspects'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0589089', 'cui_str': 'Executive cognitive functions (observable entity)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",,0.0703155,We found a significant group by time interaction for cognitive performance on the DTWT (p = 0.039).,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Raichlen', 'Affiliation': 'Human and Evolutionary Biology Section, Department of Biological Sciences, University of Southern California, 3616 Trousdale Parkway, Los Angeles, CA, 90089-0372, USA. draichle@usc.edu.'}, {'ForeName': 'Pradyumna K', 'Initials': 'PK', 'LastName': 'Bharadwaj', 'Affiliation': 'Department of Psychology, University of Arizona, 1503 E. University, Tucson, AZ, 85721, USA.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Nguyen', 'Affiliation': 'Department of Psychology, University of Arizona, 1503 E. University, Tucson, AZ, 85721, USA.'}, {'ForeName': 'Mary Kathryn', 'Initials': 'MK', 'LastName': 'Franchetti', 'Affiliation': 'Department of Psychology, University of Arizona, 1503 E. University, Tucson, AZ, 85721, USA.'}, {'ForeName': 'Erika K', 'Initials': 'EK', 'LastName': 'Zigman', 'Affiliation': 'Department of Psychology, University of Arizona, 1503 E. University, Tucson, AZ, 85721, USA.'}, {'ForeName': 'Abigail R', 'Initials': 'AR', 'LastName': 'Solorio', 'Affiliation': 'Department of Psychology, University of Arizona, 1503 E. University, Tucson, AZ, 85721, USA.'}, {'ForeName': 'Gene E', 'Initials': 'GE', 'LastName': 'Alexander', 'Affiliation': 'Department of Psychology, University of Arizona, 1503 E. University, Tucson, AZ, 85721, USA. gene.alexander@arizona.edu.'}]",BMC geriatrics,['10.1186/s12877-020-1484-5']
466,30687908,Efficacy and safety of non-ablative vaginal erbium:YAG laser treatment as a novel surgical treatment for overactive bladder syndrome: comparison with anticholinergics and β3-adrenoceptor agonists.,"PURPOSE
To examine the efficacy and safety of non-ablative vaginal erbium:YAG laser (VEL) for the treatment of overactive bladder syndrome (OAB) compared with those of two other common pharmacotherapies, namely, anticholinergics and β3-adrenoceptor agonists.
METHODS
Female subjects aged 60-69 years who presented with symptoms of OAB from 2015 to 2017 were assigned to three groups (n = 50) receiving treatment with an anticholinergic agent (4 mg fesoterodine), a β3-adrenoceptor agonist (25 mg mirabegron), or VEL (20 min/session of VEL performed thrice). The OAB symptom score (OABSS), Vaginal Health Index Scale (VHIS), and occurrence of adverse effects were examined prior to and at 1 year following treatment initiation.
RESULTS
The three groups showed significant improvement (p < 0.001) for all items of the OABSS questionnaire. Improved VHIS scores were observed only in the VEL group. Furthermore, after VEL treatment, a negative correlation was observed between questions 3 (urinary urgency) and 4 (urgency urinary incontinence) of the OABSS and VHIS. Regarding safety, no adverse events were observed in the VEL group. However, subjects in the other two groups complained of constipation, as indicated by the Constipation Assessment Scale scores, and mouth dryness. The therapeutic effects were inadequate for one and two subjects in the VEL and β3-adrenoceptor agonist groups, respectively.
CONCLUSIONS
VEL safely and effectively improved OABSS through a different mechanism than that involved in pharmacotherapy. We propose the use of VEL as a novel surgical treatment option in the field of urology.",2019,The three groups showed significant improvement (p < 0.001) for all items of the OABSS questionnaire.,"['overactive bladder syndrome (OAB', 'overactive bladder syndrome', 'Female subjects aged 60-69\xa0years who presented with symptoms of OAB from 2015 to 2017 were assigned to three groups (n\u2009=\u200950) receiving treatment with an']","['VEL', 'non-ablative vaginal erbium:YAG laser treatment', 'anticholinergic agent (4\xa0mg fesoterodine', 'non-ablative vaginal erbium:YAG laser (VEL', 'β3-adrenoceptor agonist (25\xa0mg mirabegron), or VEL', 'anticholinergics and β3-adrenoceptor agonists']","['Improved VHIS scores', 'Constipation Assessment Scale scores, and mouth dryness', 'OABSS', 'adverse events', 'questions 3 (urinary urgency) and 4 (urgency urinary incontinence) of the OABSS and VHIS', 'Efficacy and safety', 'complained of constipation', 'OAB symptom score (OABSS), Vaginal Health Index Scale (VHIS), and occurrence of adverse effects', 'efficacy and safety']","[{'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C2343853', 'cui_str': 'fesoterodine'}, {'cui': 'C0034783', 'cui_str': 'Adrenoceptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate (finding)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0222045'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0172745,The three groups showed significant improvement (p < 0.001) for all items of the OABSS questionnaire.,"[{'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Okui', 'Affiliation': ""Uro-Gyn.Net Health Care Cooperation, Dr. Okuis' Urogynecology and Urology Clinic, Ootaki 2-6, Yokosuka, Kanagawa, 238-0008, Japan. okuinobuo@gmail.com.""}]",World journal of urology,['10.1007/s00345-019-02644-7']
467,31444008,SALT Trial: Steroids after Laser Trabeculoplasty: Impact of Short-Term Anti-inflammatory Treatment on Selective Laser Trabeculoplasty Efficacy.,"PURPOSE
This study examined whether short-term use of topical nonsteroidal anti-inflammatory drug (NSAID) or steroid therapy affected the efficacy of selective laser trabeculoplasty (SLT).
DESIGN
Double-masked, randomized, placebo-controlled, dual-center, multisurgeon trial.
PARTICIPANTS
Patients older than 18 years with intraocular pressure (IOP) of more than 18 mmHg for whom the clinician decided SLT was the appropriately indicated therapy were randomized to 1 of 3 groups in a ratio of 1:1:1 as follows: ketorolac 0.5%, prednisolone 1%, or saline tears.
METHODS
After SLT, patients randomized into each group were instructed to use an unmarked drop 4 times daily starting the day of SLT and continuing for 4 additional days. The Kruskal-Wallis test and Wilcoxon rank-sum test were used for continuous variables when comparing 2 or 3 treatment groups, respectively. The Fisher exact test was used for categorical variables.
MAIN OUTCOME MEASURES
The primary outcome of this study was IOP at 12 weeks. Secondary outcome measures included IOP at 1 and 6 weeks, patient-reported pain, and detectable anterior chamber inflammation.
RESULTS
Ninety-six eyes of 85 patients fit inclusion criteria and were enrolled between the 2 sites. The NSAID, steroid, and placebo groups were similar in baseline demographics and baseline IOP (mean, 23.3±3.9 mmHg; P = 0.57). There was no statistically significant difference in IOP decrease among groups at week 6. Both the NSAID and steroid groups showed a statistically significantly greater decrease in IOP at week 12 compared with the placebo group (mean, -6.2±3.1 mmHg, -5.2±2.7 mmHg, and -3±4.3 mmHg, respectively; P = 0.02 [analysis of variance] and P = 0.002 [t test] for NSAID vs. placebo groups; P = 0.02 for steroid vs. placebo groups).
CONCLUSIONS
Significantly better IOP reduction at 12 weeks was measured in eyes treated with steroid or NSAID drops after SLT. Short-term postoperative use of NSAID or steroid drops may improve IOP reduction after SLT. Longer-term follow-up studies are indicated.",2019,"Both the NSAID and steroid groups showed a statistically significantly greater decrease in IOP at week 12 compared with the placebo group (mean, -6.2±3.1","['Patients older than 18 years with intraocular pressure (IOP) of more than 18 mmHg for whom the clinician decided SLT was the appropriately indicated therapy', 'Ninety-six eyes of 85 patients fit inclusion criteria and were enrolled between the 2 sites']","['NSAID or steroid', 'ketorolac 0.5%, prednisolone 1%, or saline tears', 'selective laser trabeculoplasty (SLT', 'placebo', 'topical nonsteroidal anti-inflammatory drug (NSAID) or steroid therapy', 'Laser Trabeculoplasty']","['baseline demographics and baseline IOP', 'IOP', 'IOP reduction', 'IOP at 1 and 6 weeks, patient-reported pain, and detectable anterior chamber inflammation', 'IOP decrease', 'Selective Laser Trabeculoplasty Efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1271447', 'cui_str': 'SLT - selective laser trabeculoplasty'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0149783', 'cui_str': 'Steroid therapy (procedure)'}, {'cui': 'C0395482', 'cui_str': 'LTP - laser trabeculoplasty'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0028841', 'cui_str': 'Ocular Hypotony'}, {'cui': 'C1271447', 'cui_str': 'SLT - selective laser trabeculoplasty'}]",85.0,0.443463,"Both the NSAID and steroid groups showed a statistically significantly greater decrease in IOP at week 12 compared with the placebo group (mean, -6.2±3.1","[{'ForeName': 'Sylvia L', 'Initials': 'SL', 'LastName': 'Groth', 'Affiliation': 'Spencer Center for Vision Research, Byers Eye Institute, Stanford University, Palo Alto, California.'}, {'ForeName': 'Eiyass', 'Initials': 'E', 'LastName': 'Albeiruti', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Nunez', 'Affiliation': 'Spencer Center for Vision Research, Byers Eye Institute, Stanford University, Palo Alto, California; Bascom Palmer Eye Institute, University of Miami, Miami, Florida; Shiley Eye Institute, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Fajardo', 'Affiliation': 'Shiley Eye Institute, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Sharpsten', 'Affiliation': 'Shiley Eye Institute, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Loewen', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Schuman', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Goldberg', 'Affiliation': 'Spencer Center for Vision Research, Byers Eye Institute, Stanford University, Palo Alto, California; Bascom Palmer Eye Institute, University of Miami, Miami, Florida; Shiley Eye Institute, University of California, San Diego, La Jolla, California. Electronic address: eye-chair@stanford.edu.'}]",Ophthalmology,['10.1016/j.ophtha.2019.05.032']
468,32162241,"Safety and tolerability of 6-month supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink in sarcopenic older adults.","AIMS
Safety and tolerability of prolonged supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink (WP-MND) was evaluated in sarcopenic older adults.
METHODS
A 13-week double-blinded, randomized, isocaloric placebo-controlled trial (PROVIDE study; n = 380) was extended with a voluntary 13-week open-label extension (OLE). OLE participants were randomized to receive daily 1 or 2 servings of WP-MND (21 g protein, 3 g leucine, 10 µg vitD and 500 mg calcium per serving). Gastro-intestinal tolerability, kidney function and serum levels of calcidiol, parathyroid hormone (PTH) and calcium were evaluated at week 0, 13 and 26.
RESULTS AND DISCUSSION
In response to the high daily protein intake (median1.5; IQR: 1.3, 1.7 g/kg BW/day), the estimated glomerular filtration rate (eGFR) increased in the test group during the RCT (p = 0.013). The same trend was observed for those participants with moderate chronic kidney disease. During OLE no eGFR change was observed in any of the groups. Serum calcidiol and calcium reached a plateau after 13-week WP-MND supplementation. As expected, PTH significantly changed in the opposite direction, decreasing during RCT in the test group (T vs C: p < 0.001) and during OLE in former control groups. During RCT, 20/366 participants with normal baseline calcidiol reached levels ≥ 100 nmol/L (T: n = 18; C: n = 2) and 6 developed albumin-corrected calcium levels > 2.55 mmol/L (T: n = 3; C: n = 3), without associated adverse events.
CONCLUSION
A 6 months intervention with up to 2 servings of WP-MND did neither result in kidney function deterioration nor symptoms of vitamin D or calcium toxicity. The product was overall well tolerated.",2020,A 6 months intervention with up to 2 servings of WP-MND did neither result in kidney function deterioration nor symptoms of vitamin D or calcium toxicity.,"['OLE participants', 'study; n\u2009=\u2009380', 'participants with moderate chronic kidney disease', 'sarcopenic older adults']","['enriched whey protein medical nutrition drink (WP-MND', 'voluntary 13-week open-label extension (OLE', 'WP-MND', 'prolonged supplementation with a vitamin D, calcium and leucine', 'vitamin D, calcium and leucine-enriched whey protein medical nutrition drink', 'isocaloric placebo']","['kidney function deterioration nor symptoms of vitamin D or calcium toxicity', 'tolerated', 'Gastro-intestinal tolerability, kidney function and serum levels of calcidiol, parathyroid hormone (PTH) and calcium', 'glomerular filtration rate (eGFR', 'Safety and tolerability', 'eGFR change', 'Serum calcidiol and calcium']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0681013,A 6 months intervention with up to 2 servings of WP-MND did neither result in kidney function deterioration nor symptoms of vitamin D or calcium toxicity.,"[{'ForeName': 'Jürgen M', 'Initials': 'JM', 'LastName': 'Bauer', 'Affiliation': 'Center for Geriatric Medicine, University Heidelberg, Agaplesion Bethanien Krankenhaus Heidelberg, Heidelberg, Germany. Juergen.Bauer@bethanien-heidelberg.de.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mikušová', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.'}, {'ForeName': 'Sjors', 'Initials': 'S', 'LastName': 'Verlaan', 'Affiliation': 'Department of Internal Medicine, Section of Gerontology and Geriatrics, VU, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Bautmans', 'Affiliation': 'Frailty in Ageing Research Group (FRIA), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Brandt', 'Affiliation': 'Human Nutrition Research Centre, School of Agriculture, Food and Rural Development, Newcastle University Institute for Ageing, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lorenzo M', 'Initials': 'LM', 'LastName': 'Donini', 'Affiliation': 'Department of Experimental Medicine, Section of Medical Pathophysiology, Endocrinology and Human Nutrition, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Maggio', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Geriatrics, University of Parma, Parma, Italy.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Mets', 'Affiliation': 'Frailty in Ageing Research Group (FRIA), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Sander L J', 'Initials': 'SLJ', 'LastName': 'Wijers', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.'}, {'ForeName': 'Jossie A', 'Initials': 'JA', 'LastName': 'Garthoff', 'Affiliation': 'Danone Food Safety Center, Utrecht, The Netherlands.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Luiking', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.'}, {'ForeName': 'Cornel', 'Initials': 'C', 'LastName': 'Sieber', 'Affiliation': 'Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cederholm', 'Affiliation': 'Department of Public Health and Caring Sciences/Clinical Nutrition and Metabolism, Department of Geriatric Medicine, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Aging clinical and experimental research,['10.1007/s40520-020-01519-x']
469,32048478,Does spatial awareness training affect anatomy learning in medical students?,"Spatial ability (SA) is the cognitive capacity to understand and mentally manipulate concepts of objects, remembering relationships among their parts and those of their surroundings. Spatial ability provides a learning advantage in science and may be useful in anatomy and technical skills in health care. This study aimed to assess the relationship between SA and anatomy scores in first- and second-year medical students. The training sessions focused on the analysis of the spatial component of objects' structure and their interaction as applied to medicine; SA was tested using the Visualization of Rotation (ROT) test. The intervention group (n = 29) received training and their pre- and post-training scores for the SA tests were compared to a control group (n = 75). Both groups improved their mean scores in the follow-up SA test (P < 0.010). There was no significant difference in SA scores between the groups for either SA test (P = 0.31, P = 0.90). The SA scores for female students were significantly lower than for male students, both at baseline and follow-up (P < 0.010). Anatomy training and assessment were administered by the anatomy department of the medical school, and examination scores were not significantly different between the two groups post-intervention (P = 0.33). However, participants with scores in the bottom quartile for SA performed worse in the anatomy questions (P < 0.001). Spatial awareness training did not improve SA or anatomy scores; however, SA may identify students who may benefit from additional academic support.",2020,Both groups improved their mean scores in the follow-up SA test (P < 0.010).,"['first- and second-year medical students', 'medical students']","['Spatial awareness training', 'spatial awareness training', 'Spatial ability (SA', 'training and their pre- and post-training scores for the SA tests']","['mean scores', 'SA scores', 'SA or anatomy scores']","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0584950', 'cui_str': 'Spatial awareness (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0679024', 'cui_str': 'Spatial Ability'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}]",75.0,0.0139337,Both groups improved their mean scores in the follow-up SA test (P < 0.010).,"[{'ForeName': 'Rene A', 'Initials': 'RA', 'LastName': 'Gonzales', 'Affiliation': 'Department of Medical Education, Brighton and Sussex Medical School, University of Sussex, Brighton, United Kingdom.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Ferns', 'Affiliation': 'Department of Medical Education, Brighton and Sussex Medical School, University of Sussex, Brighton, United Kingdom.'}, {'ForeName': 'Marc A T M', 'Initials': 'MATM', 'LastName': 'Vorstenbosch', 'Affiliation': 'Department of Anatomy, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Claire F', 'Initials': 'CF', 'LastName': 'Smith', 'Affiliation': 'Department of Medical Education, Brighton and Sussex Medical School, University of Sussex, Brighton, United Kingdom.'}]",Anatomical sciences education,['10.1002/ase.1949']
470,31852207,Regulatory effects of propofol on high-dose remifentanil-induced hyperalgesia.,"We aimed to evaluate the regulatory effects of propofol on high-dose remifentanil-induced hyperalgesia. A total of 180 patients receiving laparoscopic cholecystectomy were randomly divided into sevoflurane + high-dose remifentanil (SH) group, sevoflurane + low-dose remifentanil (SL) group and propofol + high-dose remifentanil group (PH) group (n=60). After intravenous administration of midazolam, SH and SL groups were induced with sevoflurane and remifentanil, and PH group was induced with propofol and remifentanil. During anesthesia maintenance, SH and SL groups were given 0.3 microg/kg/min and 0.1 microg/kg/min sevoflurane and remifentanil respectively, and PH group was given 0.3 microg/kg/min propofol and remifentanil. The three groups had significantly different awakening time, extubation time and total dose of remifentanil (P<0.001). Compared with SL group, periumbilical mechanical pain thresholds 6 h and 24 h after surgery significantly decreased in SH group (P<0.05), and the visual analog scale (VAS) scores significantly increased 30 min, 2 h and 6 h after surgery (P<0.05). Compared with SH group, periumbilical mechanical thresholds 6 h and 24 h after surgery were significantly higher in PH group (P<0.05), and VAS scores 30 min, 2 h and 6 h after surgery were significantly lower (P<0.05). PH group first used patient-controlled intravenous analgesia pump significantly later than SL group did (P<0.05). The total consumptions of sufentanil in PH and SL groups were significantly lower than that of SH group (P<0.05). The incidence rates of bradycardia and postoperative chill in PH and SH groups were significantly higher than those of SL group (P<0.05). Anesthesia by infusion of high-dose remifentanil plus sevoflurane caused postoperative hyperalgesia which was relieved through intravenous anesthesia with propofol.",2020,PH group first used patient-controlled intravenous analgesia pump significantly later than SL group did (P<0.05).,['180 patients receiving laparoscopic cholecystectomy'],"['midazolam, SH and SL', 'propofol', 'sevoflurane + high-dose remifentanil (SH) group, sevoflurane + low-dose remifentanil (SL) group and propofol + high-dose remifentanil group (PH) group ', 'SL', 'sevoflurane and remifentanil', 'propofol and remifentanil', 'remifentanil plus sevoflurane', 'SH', 'PH']","['incidence rates of bradycardia and postoperative chill', 'periumbilical mechanical pain', 'total consumptions of sufentanil', 'postoperative hyperalgesia', 'hyperalgesia', 'awakening time, extubation time and total dose of remifentanil', 'periumbilical mechanical thresholds', 'visual analog scale (VAS) scores', 'VAS scores']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0457792', 'cui_str': 'Periumbilical (qualifier value)'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",180.0,0.0186311,PH group first used patient-controlled intravenous analgesia pump significantly later than SL group did (P<0.05).,"[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Department of Anesthesiology, Suqian First Hospital, Suqian, Jiangsu Province, P. R. China; Department of Anesthesiology, Jiangsu Province Hospital, Nanjing, Jiangsu Province, P. R. China. zhuweijph@yahoo.com, Department of Anesthesiology, Suqian First Hospital, Suqian, Jiangsu Province, P. R. China. tianyufengsfh@foxmail.com.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ''}]",Physiological research,[]
471,31491542,Factors associated with effective inhaler technique among children with moderate to severe asthma.,,2019,,['children with moderate to severe asthma'],[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]",[],[],,0.0150046,,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Volerman', 'Affiliation': 'Departments of Medicine and Pediatrics, University of Chicago, Chicago, Illinois. Electronic address: avolerman@uchicago.edu.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Fierstein', 'Affiliation': 'Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago Illinois.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Boon', 'Affiliation': 'Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago Illinois.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Kanaley', 'Affiliation': 'Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago Illinois.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Kan', 'Affiliation': ""Division of Academic General Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University, Chicago, Illinois.""}, {'ForeName': 'Deneen', 'Initials': 'D', 'LastName': 'Vojta', 'Affiliation': 'UnitedHealth Group, Minnetonka, Minnesota.'}, {'ForeName': 'Ruchi', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': ""Division of Academic General Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University, Chicago, Illinois.""}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2019.08.017']
472,31302314,Online personalized feedback intervention for cannabis-using college students reduces cannabis-related problems among women.,"There is growing evidence that college cannabis use is associated with use-related problems, yet efforts to reduce cannabis-related problems via online personalized feedback interventions (PFIs) have had limited success in significantly reducing risky cannabis use among college students. However, men and women may respond differently to such interventions and failure to examine effects of gender may obfuscate intervention effects. Thus, the current study tested intervention effects (moderated by gender) of an online, university-specific PFI for high-risk cannabis users (i.e., past-month cannabis users with at least one recent cannabis-related problem) who were randomly assigned to an online PFI (n = 102) or an online personalized normative feedback-only condition (PNF-only; n = 102). Gender moderated the relationship between condition and one-month follow-up problems, such that women in the PFI condition reported fewer cannabis-related problems at follow-up than women in the PNF-only condition. Men in the PFI condition did not significantly differ from men in the PNF-only condition on use-related problems at follow-up. Cannabis PFIs may be efficacious for reducing cannabis use-related problems among undergraduate women (but not men) and women may benefit from online interventions that include problem-focused components.",2019,Men in the PFI condition did not significantly differ from men in the PNF-only condition on use-related problems at follow-up.,"['college students', 'cannabis-using college students reduces cannabis-related problems among women', 'high-risk cannabis users (i.e., past-month cannabis users with at least one recent cannabis-related problem']","['Online personalized feedback intervention', 'online PFI (n\u202f=\u202f102) or an online personalized normative feedback-only condition (PNF-only; n\u202f=\u202f102', 'Cannabis PFIs']",[],"[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0936079', 'cui_str': 'Hemp Plant'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}]",[],,0.145664,Men in the PFI condition did not significantly differ from men in the PNF-only condition on use-related problems at follow-up.,"[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Walukevich-Dienst', 'Affiliation': 'Louisiana State University, Department of Psychology, 236 Audubon Hall, Baton Rouge, LA 70803, United States of America.'}, {'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': 'University of Houston, Department of Psychology, 220 Heyne Building, Houston, TX 77024, United States of America.'}, {'ForeName': 'Julia D', 'Initials': 'JD', 'LastName': 'Buckner', 'Affiliation': 'Louisiana State University, Department of Psychology, 236 Audubon Hall, Baton Rouge, LA 70803, United States of America. Electronic address: jbuckner@lsu.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.106040']
473,31330465,Excessive substance use screening to encourage behaviour change among young people in primary care: Pilot study in preparation for a randomized trial.,"INTRODUCTION
Alcohol, cannabis and other substance use affects young people's health. Primary care physicians are encouraged to screen and provide brief interventions for substance use in this population, but implementation is often limited. Pre-consultation self-administered screening may decrease at-risk substance use and could have population-level benefits. A randomized controlled trial is planned to test this hypothesis. The present pilot study's objective was to assess the feasibility of methods for the future trial.
METHODS
The parallel-group randomized controlled pilot trial was undertaken in 6 primary care practices in Geneva, Switzerland, over 2 months. 29 patients aged 15-24 years consulting for any reason were randomly assigned to intervention (substance use screening, n = 14) or control (physical activity questionnaire, n = 15) using computer-generated random number tables. Outcomes were assessed one month later by telephone questionnaire. Physicians, practice staff and outcome assessors were blinded to allocation. The primary outcomes were feasibility of procedures and acceptability to participants, primary care physicians and practice staff.
RESULTS
Of 16 participants reached at follow-up, 3 reported excessive substance use. Methods were acceptable to all participants, especially regarding confidentiality. Three participants were lost due to technical difficulties with the consent form. No major problems with study methods were reported in the practices. 4 practices did not meet recruitment targets.
CONCLUSION
The study procedures proved to be feasible in primary care practices and acceptable to young people who were readily available to participate. The main challenge for the future full-sized trial will be to ensure that recruitment targets can be met.",2019,No major problems with study methods were reported in the practices.,"['6 primary care practices in Geneva, Switzerland, over 2\u202fmonths', 'young people in primary care', '29 patients aged 15-24\u202fyears consulting for any reason', 'young people who were readily available to participate']","['Excessive substance use screening', 'intervention (substance use screening, n\u202f=\u202f14) or control (physical activity questionnaire, n\u202f=\u202f15) using computer-generated random number tables']","['feasibility of procedures and acceptability to participants, primary care physicians and practice staff']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1706074', 'cui_str': 'Table'}]","[{'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}]",29.0,0.102289,No major problems with study methods were reported in the practices.,"[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Pfarrwaller', 'Affiliation': 'Primary Care Unit, Faculty of medicine, University of Geneva, Geneva, Switzerland. Electronic address: eva.pfarrwaller@unige.ch.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Meynard', 'Affiliation': 'Primary Care Unit, Faculty of medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Reyre', 'Affiliation': 'Primary Care Unit, Faculty of medicine, University of Geneva, Geneva, Switzerland; Centre de recherche en Epidémiologie et Santé des Populations (CESP), INSERM, U1178 Villejuif, France.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Sommer', 'Affiliation': 'Primary Care Unit, Faculty of medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Dagmar M', 'Initials': 'DM', 'LastName': 'Haller', 'Affiliation': 'Primary Care Unit, Faculty of medicine, University of Geneva, Geneva, Switzerland; Unité Santé Jeunes, Department of Primary Care and Department of Gynecology and Pediatrics, Geneva University Hospitals, Geneva, Switzerland.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.106049']
474,32157608,A telephone-based education and support intervention for Rural Breast Cancer Survivors: a randomized controlled trial comparing two implementation strategies in rural Florida.,"PURPOSE
To compare two implementation telephone-based strategies of an evidence-based educational and support intervention to Rural Breast Cancer Survivors (RBCS) in which education was delivered early or after the support component.
METHODS
Florida RBCS participated in a 12-month randomized clinical trial (RCT) with two arms: Early Education and Support (EE-S) and Support and Delayed Education (S-DE). Arms differed in the timing of 6 support and 3 education sessions. Main outcome was quality of life (QOL, SF-36 physical and mental composite scores [PCS, MCS]). Secondary outcomes were depressive symptoms (Centers for Epidemiologic Studies Depression Scale, CES-D), mood (Profile of Mood States, POMS), and social support (Medical Outcomes Study Social Support Survey, MOS-SSS). Outcomes were analyzed longitudinally using repeated measures models fitted with linear mixed methods.
RESULTS
Of 432 RBCS (mean 25.6 months from diagnosis), about 48% were 65+, 73% married/partnered, and 28% with ≤high school education. There were no differences between EE-S and S-DE in demographics or outcomes at baseline (mean (standard deviation): SF-36 PCS, 44.88 (10.6) vs. 45.08 (10.6); MCS, 49.45 (11.1) vs. 48.1 (11.9); CES-D, 10.11 (9.8) vs. 10.86 (10.5); POMS-SF, 23.95 (38.6) vs. 26.35 (38.8); MOS-SSS, 79.2 (21.2) vs. 78.66 (21.2)) or over time. One exception was slightly worse mean scores at month 9 in MCS (Cohen's d, - 0.22; 95% CI, - 0.38, - 0.06) and POMS (Cohen's d, 0.23; 95% CI, 0.07, 0.39) for EE-S vs. S-DE.
CONCLUSIONS
The implementation strategies were equivalent.
IMPLICATIONS FOR CANCER SURVIVORS
Enhancing support may be considered before delivering not-in-person interventions to RBCS.",2020,"There were no differences between EE-S and S-DE in demographics or outcomes at baseline (mean (standard deviation): SF-36 PCS, 44.88 (10.6) vs. 45.08","['rural Florida', 'Rural Breast Cancer Survivors', 'Rural Breast Cancer Survivors (RBCS', 'Of 432 RBCS (mean 25.6\xa0months from diagnosis', 'Florida RBCS participated in a 12-month randomized clinical trial (RCT) with two arms']","['Early Education and Support (EE-S) and Support and Delayed Education (S-DE', 'telephone-based education and support intervention', 'implementation telephone-based strategies of an evidence-based educational and support intervention']","['depressive symptoms (Centers for Epidemiologic Studies Depression Scale, CES-D), mood (Profile of Mood States, POMS), and social support (Medical Outcomes Study Social Support Survey, MOS-SSS', 'quality of life (QOL, SF-36 physical and mental composite scores [PCS, MCS', 'POMS']","[{'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0002783', 'cui_str': 'Epidemiological Studies'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0037438'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.207277,"There were no differences between EE-S and S-DE in demographics or outcomes at baseline (mean (standard deviation): SF-36 PCS, 44.88 (10.6) vs. 45.08","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Meneses', 'Affiliation': 'School of Nursing, Office of Research and Scholarship, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pisu', 'Affiliation': ""O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA. mpisu@uab.edu.""}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, Office of Research and Scholarship, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Benz', 'Affiliation': 'School of Nursing, Office of Research and Scholarship, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Xiaogang', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Department of Mathematical Sciences, The University of Texas at El Paso, El Paso, TX, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McNees', 'Affiliation': 'School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00866-y']
475,32157684,Empowering Older Adults to Discuss Advance Care Planning During Clinical Visits: The PREPARE Randomized Trial.,"BACKGROUND/OBJECTIVES
A patient-directed, online program (PREPARE for Your Care [PREPARE]; prepareforyourcare.org) has been shown to increase advance care planning (ACP) documentation. However, the mechanisms underlying PREPARE are unknown. Our objectives were to compare the efficacy of PREPARE plus an easy-to-read advance directive (AD) vs an AD alone to increase active patient participation in ACP discussions during clinic visits and to examine effects of active patient participation on ACP documentation.
DESIGN
Audio recordings of postintervention primary care visits from two randomized trials (2013-2016).
SETTING
Seven primary care clinics at a veterans affair and safety-net hospital in San Francisco, CA.
PARTICIPANTS
English- and Spanish-speaking adults, aged 55 years and older, with two or more chronic/serious conditions.
INTERVENTION
PREPARE plus an easy-to-read AD or an AD alone.
MEASUREMENTS
The primary outcome was the number of active patient participation utterances about ACP (eg, asking questions, stating preferences) measured by the validated Active Patient Participation Coding Scheme. We examined differences in utterances by study arm using mixed effects negative binomial models and utterances as a mediator of PREPARE's effect on documentation using adjusted logistic regression. Models were adjusted for health literacy, prior care planning, and clinician.
RESULTS
Among 393 participants, the mean (SD) age was 66 (8.1) years, 120 (30.5%) had limited health literacy, and 99 (25.2%) were Spanish speaking. PREPARE plus the AD resulted in 41% more active patient participation in ACP discussions compared with the AD alone (mean [SD] = 10.1 [16.8] vs 6.6 [13.4] utterances; incidence rate ratio = 1.41; 95% confidence interval = 1.00-1.98). For every additional utterance, participants had 15% higher odds of ACP documentation, and active patient participation accounted for 16% of PREPARE's effect on documentation.
CONCLUSIONS
The PREPARE program and easy-to-read AD empowered patients to actively participate in ACP discussions during clinical visits more than the AD alone. Increased activation was associated with increased ACP documentation. Therefore, PREPARE may mitigate barriers to ACP among English- and Spanish-speaking older adults.
TRIAL REGISTRATION
ClinicalTrials.gov identifiers: ""Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making (PREPARE)"" NCT01990235 and ""Preparing Spanish-Speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)"" NCT02072941. J Am Geriatr Soc 68:1210-1217, 2020.",2020,PREPARE plus the AD resulted in 41% more active patient participation in ACP discussions compared with the AD alone (mean [SD] = 10.1 [16.8] vs 6.6 [13.4] utterances; incidence rate ratio = 1.41; 95% confidence interval = 1.00-1.98).,"['393 participants, the mean (SD) age was 66 (8.1) years, 120 (30.5%) had limited health literacy, and 99 (25.2%) were Spanish speaking', 'Seven primary care clinics at a veterans affair and safety-net hospital in San Francisco, CA', 'Empowering Older Adults', 'English- and Spanish-speaking adults, aged 55\u2009years and older, with two or more chronic/serious conditions']","['PREPARE plus an easy-to-read AD or an AD alone', 'Advance Care Planning']","['active patient participation in ACP discussions', 'number of active patient participation utterances about ACP (eg, asking questions, stating preferences', 'Increased activation']","[{'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332219', 'cui_str': 'Easy (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0030699', 'cui_str': 'Patient Involvement'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0566217', 'cui_str': 'Does ask questions (finding)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0986627,PREPARE plus the AD resulted in 41% more active patient participation in ACP discussions compared with the AD alone (mean [SD] = 10.1 [16.8] vs 6.6 [13.4] utterances; incidence rate ratio = 1.41; 95% confidence interval = 1.00-1.98).,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Freytag', 'Affiliation': 'Center for Innovations in Quality Effectiveness, and Safety, Houston, Texas.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Street', 'Affiliation': 'Center for Innovations in Quality Effectiveness, and Safety, Houston, Texas.'}, {'ForeName': 'Deborah E', 'Initials': 'DE', 'LastName': 'Barnes', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'San Francisco Veterans Affairs Health Care System, San Francisco, California.'}, {'ForeName': 'Aiesha M', 'Initials': 'AM', 'LastName': 'Volow', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Shim', 'Affiliation': 'Department of Social and Behavioral Sciences, School of Nursing, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Stewart C', 'Initials': 'SC', 'LastName': 'Alexander', 'Affiliation': 'Department of Consumer Science, Purdue University, West Lafayette, Indiana.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Innovation and Implementation Center for Aging and Palliative Care, Division of Geriatrics, Department of Medicine, University of California, San Francisco, San Francisco, California.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16405']
476,31290996,"A phase 1 and randomized, placebo-controlled phase 2 trial of bevacizumab plus dasatinib in patients with recurrent glioblastoma: Alliance/North Central Cancer Treatment Group N0872.","BACKGROUND
Src signaling is markedly upregulated in patients with invasive glioblastoma (GBM) after the administration of bevacizumab. The Src family kinase inhibitor dasatinib has been found to effectively block bevacizumab-induced glioma invasion in preclinical models, which led to the hypothesis that combining bevacizumab with dasatinib could increase bevacizumab efficacy in patients with recurrent GBM.
METHODS
After the completion of the phase 1 component, the phase 2 trial (ClinicalTrials.gov identifier NCT00892177) randomized patients with recurrent GBM 2:1 to receive 100 mg of oral dasatinib twice daily (arm A) or placebo (arm B) on days 1 to 14 of each 14-day cycle combined with 10 mg/kg of intravenous bevacizumab on day 1 of each 14-day cycle. The primary endpoint was 6-month progression-free survival (PFS6).
RESULTS
In the 121 evaluable patients, the PFS6 rate was numerically, but not statistically, higher in arm A versus arm B (28.9% [95% CI, 19.5%-40.0%] vs 18.4% [95% CI, 7.7%-34.4%]; P = .22). Similarly, there was no significant difference in the median overall survival noted between the treatment arms (7.3 months and 7.7 months, respectively; P = .93). The objective response rate was 15.7% in arm A and 26.3% in arm B (P = .52), but with a significantly longer duration in patients treated on arm A (16.3 months vs 2 months). The incidence of grade ≥3 toxicity was comparable between treatment arms, with hematologic toxicities occurring more frequently in arm A versus arm B (15.7% vs 7.9%) (adverse events were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]). Correlative tissue analysis demonstrated an association between pSRC/LYN signaling in patient tumors and outcome.
CONCLUSIONS
Despite upregulation of Src signaling in patients with GBM, the combination of bevacizumab with dasatinib did not appear to significantly improve the outcomes of patients with recurrent GBM compared with bevacizumab alone.",2019,"The objective response rate was 15.7% in arm A and 26.3% in arm B (P = .52), but with a significantly longer duration in patients treated on arm A (16.3 months vs 2 months).","['patients with recurrent glioblastoma: Alliance/North Central Cancer Treatment Group N0872', 'patients with GBM', 'patients with recurrent GBM', 'patients with invasive glioblastoma (GBM) after the administration of']","['bevacizumab plus dasatinib', '100\xa0mg of oral dasatinib twice daily (arm A) or placebo', 'bevacizumab', 'placebo']","['objective response rate', 'incidence of grade ≥3 toxicity', 'hematologic toxicities', 'median overall survival', 'PFS6 rate', 'bevacizumab efficacy', '6-month progression-free survival (PFS6']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.270075,"The objective response rate was 15.7% in arm A and 26.3% in arm B (P = .52), but with a significantly longer duration in patients treated on arm A (16.3 months vs 2 months).","[{'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Galanis', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'S Keith', 'Initials': 'SK', 'LastName': 'Anderson', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Twohy', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Xiomara W', 'Initials': 'XW', 'LastName': 'Carrero', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jesse G', 'Initials': 'JG', 'LastName': 'Dixon', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'David Dinh', 'Initials': 'DD', 'LastName': 'Tran', 'Affiliation': 'Oncology Division, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Suriya A', 'Initials': 'SA', 'LastName': 'Jeyapalan', 'Affiliation': 'Department of Neurology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Anderson', 'Affiliation': 'Department of Hematology/Oncology, Regions Hospital, St Paul, Minnesota.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ryan W', 'Initials': 'RW', 'LastName': 'Feathers', 'Affiliation': 'Department of Cancer Biology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Giannini', 'Affiliation': 'Department of Pathology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Buckner', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Panos Z', 'Initials': 'PZ', 'LastName': 'Anastasiadis', 'Affiliation': 'Department of Cancer Biology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schiff', 'Affiliation': 'Department of Neurology, University of Virginia Medical Center, Charlottesville, Virginia.'}]",Cancer,['10.1002/cncr.32340']
477,31693077,Efficacy and Safety of Dupilumab in Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis: A Phase 3 Randomized Clinical Trial.,"Importance
Adolescents with atopic dermatitis (AD) have high disease burden negatively affecting quality of life, with limited treatment options. The efficacy and safety of dupilumab, a monoclonal antibody, approved for treatment in adolescent patients with inadequately controlled AD, remain unknown in this patient population.
Objective
To assess the efficacy and safety of dupilumab monotherapy in adolescents with moderate to severe inadequately controlled AD.
Design, Setting, and Participants
A randomized, double-blind, parallel-group, phase 3 clinical trial was conducted at 45 US and Canadian centers between March 21, 2017, and June 5, 2018. A total of 251 adolescents with moderate to severe AD inadequately controlled by topical medications or for whom topical therapy was inadvisable were included.
Interventions
Patients were randomized (1:1:1; interactive-response system; stratified by severity and body weight) to 16-week treatment with dupilumab, 200 mg (n = 43; baseline weight <60 kg), or dupilumab, 300 mg (n = 39; baseline weight ≥60 kg), every 2 weeks; dupilumab, 300 mg, every 4 weeks (n = 84); or placebo (n = 85).
Main Outcomes and Measures
Proportion of patients with 75% or more improvement from baseline in Eczema Area and Severity Index (EASI-75) (scores range from 0 to 72, with higher scores indicating greater severity) and Investigator's Global Assessment (IGA) 0 or 1 on a 5-point scale (scores range from 0 to 4, with higher scores indicating greater severity) at week 16.
Results
A total of 251 patients were randomized (mean [SD] age, 14.5 [1.7] years; 148 [59.0%] male). Of 250 patients with data available on concurrent allergic conditions, most had comorbid type 2 diseases (asthma, 134 [53.6%]; food allergies, 60.8%; allergic rhinitis, 65.6%). A total of 240 patients (95.6%) completed the study. Dupilumab achieved both coprimary end points at week 16. The proportion of patients with EASI-75 improvement from baseline increased (every 2 weeks, 41.5%; every 4 weeks, 38.1%; placebo, 8.2%) with differences vs placebo of 33.2% (95% CI, 21.1%-45.4%) for every 2 weeks and 29.9% (95% CI, 17.9%-41.8%) for every 4 weeks (P < .001). Efficacy of the every-2-week regimen was generally superior to the every-4-week regimen. Patients in the dupilumab arms had higher percentage values of conjunctivitis (every 2 weeks, 9.8%; every 4 weeks, 10.8%; placebo, 4.7%) and injection-site reactions (every 2 weeks, 8.5%; every 4 weeks, 6.0%; placebo, 3.5%), and lower nonherpetic skin infections (every 2 weeks, 9.8%; every 4 weeks, 9.6%; placebo, 18.8%).
Conclusions and Relevance
In this study, dupilumab significantly improved AD signs, symptoms, and quality of life in adolescents with moderate to severe AD, with an acceptable safety profile. Placebo-corrected efficacy and safety of dupilumab were similar in adolescents and adults.
Trial Registration
ClinicalTrials.gov identifier: NCT03054428.",2020,"Patients in the dupilumab arms had higher percentage values of conjunctivitis (every 2 weeks, 9.8%; every 4 weeks, 10.8%; placebo, 4.7%) and injection-site reactions (every 2 weeks, 8.5%; every 4 weeks, 6.0%; placebo, 3.5%), and lower nonherpetic skin infections (every 2 weeks, 9.8%; every 4 weeks, 9.6%; placebo, 18.8%).
","['adolescent patients with inadequately controlled AD', 'Adolescents with atopic dermatitis (AD', '250 patients with data available on concurrent allergic conditions, most had comorbid type 2 diseases (asthma, 134 [53.6%]; food allergies, 60.8%; allergic rhinitis, 65.6', '251 adolescents with moderate to severe AD inadequately controlled by topical medications or for whom topical therapy was inadvisable were included', 'adolescents with moderate to severe inadequately controlled AD', 'adolescents with moderate to severe AD', 'adolescents and adults', 'A total of 251 patients were randomized (mean [SD] age, 14.5 [1.7] years; 148 [59.0%] male', 'Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis', '240 patients (95.6%) completed the study']","['dupilumab, 200 mg (n\u2009=\u200943; baseline weight <60 kg), or dupilumab', 'Placebo', 'placebo', 'dupilumab', 'Dupilumab', 'dupilumab monotherapy']","['AD signs, symptoms, and quality of life', 'injection-site reactions', ""severity) and Investigator's Global Assessment (IGA) 0 or 1 on a 5-point scale"", 'efficacy and safety', 'Efficacy', 'Efficacy and Safety', 'nonherpetic skin infections', 'proportion of patients with EASI-75 improvement', 'Eczema Area and Severity Index (EASI-75', 'percentage values of conjunctivitis']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0851444', 'cui_str': 'Allergic condition'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0016470', 'cui_str': 'Food Allergy'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037278', 'cui_str': 'Skin Diseases, Infectious'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}]",251.0,0.507851,"Patients in the dupilumab arms had higher percentage values of conjunctivitis (every 2 weeks, 9.8%; every 4 weeks, 10.8%; placebo, 4.7%) and injection-site reactions (every 2 weeks, 8.5%; every 4 weeks, 6.0%; placebo, 3.5%), and lower nonherpetic skin infections (every 2 weeks, 9.8%; every 4 weeks, 9.6%; placebo, 18.8%).
","[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': 'Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Siegfried', 'Affiliation': 'Department of Pediatrics, School of Medicine, Saint Louis University, St. Louis, Missouri.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Boguniewicz', 'Affiliation': 'Department of Pediatrics, National Jewish Health and University of Colorado School of Medicine, Denver.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Sher', 'Affiliation': 'Peninsula Research Associates, Rolling Hills Estates, California.'}, {'ForeName': 'Melinda J', 'Initials': 'MJ', 'LastName': 'Gooderham', 'Affiliation': 'Skin Centre for Dermatology, Peterborough, Ontario, Canada.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pariser', 'Affiliation': 'Department of Dermatology, Eastern Virginia Medical School, Norfolk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Weisman', 'Affiliation': 'Advanced Medical Research, Atlanta, Georgia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lockshin', 'Affiliation': 'US Dermatology Partners, Rockville, Maryland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hultsch', 'Affiliation': 'Sanofi Genzyme, Cambridge, Massachusetts.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Kamal', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Davis', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Bolanle', 'Initials': 'B', 'LastName': 'Akinlade', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Staudinger', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Hamilton', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Stahl', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}]",JAMA dermatology,['10.1001/jamadermatol.2019.3336']
478,31707827,Dobutamine Stress Echocardiography Ischemia as a Predictor of the Placebo-Controlled Efficacy of Percutaneous Coronary Intervention in Stable Coronary Artery Disease: The Stress Echocardiography-Stratified Analysis of ORBITA.,"BACKGROUND
Dobutamine stress echocardiography is widely used to test for ischemia in patients with stable coronary artery disease. In this analysis, we studied the ability of the prerandomization stress echocardiography score to predict the placebo-controlled efficacy of percutaneous coronary intervention (PCI) within the ORBITA trial (Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina).
METHODS
One hundred eighty-three patients underwent dobutamine stress echocardiography before randomization. The stress echocardiography score is broadly the number of segments abnormal at peak stress, with akinetic segments counting double and dyskinetic segments counting triple. The ability of prerandomization stress echocardiography to predict the placebo-controlled effect of PCI on response variables was tested by using regression modeling.
RESULTS
At prerandomization, the stress echocardiography score was 1.56±1.77 in the PCI arm (n=98) and 1.61±1.73 in the placebo arm (n=85). There was a detectable interaction between prerandomization stress echocardiography score and the effect of PCI on angina frequency score with a larger placebo-controlled effect in patients with the highest stress echocardiography score ( P interaction =0.031). With our sample size, we were unable to detect an interaction between stress echocardiography score and any other patient-reported response variables: freedom from angina ( P interaction =0.116), physical limitation ( P interaction =0.461), quality of life ( P interaction =0.689), EuroQOL 5 quality-of-life score ( P interaction =0.789), or between stress echocardiography score and physician-assessed Canadian Cardiovascular Society angina class ( P interaction =0.693), and treadmill exercise time ( P interaction =0.426).
CONCLUSIONS
The degree of ischemia assessed by dobutamine stress echocardiography predicts the placebo-controlled efficacy of PCI on patient-reported angina frequency. The greater the downstream stress echocardiography abnormality caused by a stenosis, the greater the reduction in symptoms from PCI.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02062593.",2019,,['Stable Coronary Artery Disease'],"['Placebo', 'Percutaneous Coronary Intervention', 'Dobutamine Stress Echocardiography Ischemia']",[],"[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0949700', 'cui_str': 'Echocardiography, Stress, Dobutamine'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",[],,0.158421,,"[{'ForeName': 'Rasha K', 'Initials': 'RK', 'LastName': 'Al-Lamee', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Shun-Shin', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Howard', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Alexandra N', 'Initials': 'AN', 'LastName': 'Nowbar', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Rajkumar', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Sayan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Sukhjinder', 'Initials': 'S', 'LastName': 'Nijjer', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Petraco', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': 'Essex Cardiothoracic Centre, Basildon, UK (J.D., T.K., K.T.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Keeble', 'Affiliation': 'Essex Cardiothoracic Centre, Basildon, UK (J.D., T.K., K.T.).'}, {'ForeName': 'Kare', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Essex Cardiothoracic Centre, Basildon, UK (J.D., T.K., K.T.).'}, {'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Malik', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Bual', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Yousif', 'Initials': 'Y', 'LastName': 'Ahmad', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Seligman', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Andrew S P', 'Initials': 'ASP', 'LastName': 'Sharp', 'Affiliation': 'Cardiff Royal Infirmary, UK (A.S.P.S.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gerber', 'Affiliation': 'East Sussex Healthcare NHS Trust, Hastings, UK (R.G.).'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Talwar', 'Affiliation': 'Royal Bournemouth and Christchurch NHS Trust, UK (S. Talwar).'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Assomull', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., R.A., G.C., G.K., J.M., J.E.D., D.P.F.).'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Cole', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Niall G', 'Initials': 'NG', 'LastName': 'Keenan', 'Affiliation': 'West Hertfordshire Hospitals NHS Trust, Watford, UK (N.G.K., J.S.).'}, {'ForeName': 'Gajen', 'Initials': 'G', 'LastName': 'Kanaganayagam', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., R.A., G.C., G.K., J.M., J.E.D., D.P.F.).'}, {'ForeName': 'Joban', 'Initials': 'J', 'LastName': 'Sehmi', 'Affiliation': 'West Hertfordshire Hospitals NHS Trust, Watford, UK (N.G.K., J.S.).'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Wensel', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': 'Vanderbilt University School of Medicine, Department of Biostatistics, Nashville, TN (F.E.H.).'}, {'ForeName': 'Jamil', 'Initials': 'J', 'LastName': 'Mayet', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thom', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Davies', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., R.A., G.C., G.K., J.M., J.E.D., D.P.F.).'}, {'ForeName': 'Darrel P', 'Initials': 'DP', 'LastName': 'Francis', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.042918']
479,32147200,Economic evaluation of individualized nutritional support in medical inpatients: Secondary analysis of the EFFORT trial.,"BACKGROUND & AIMS
Existing guidelines support the importance of nutritional interventions for medical inpatients at malnutrition risk to alleviate the impact of malnutrition on outcomes. While recent studies have reported positive effects of nutritional support on health outcomes, limited evidence exists on whether in-hospital nutritional support also results in economic advantages. We report the results of the economic evaluation of EFFORT-a pragmatic, investigator-initiated, open-label, multicenter trial.
METHODS
A total of 2028 medical inpatients at nutritional risk were randomly assigned to receive individualized nutritional support to reach protein and energy goals (intervention group; n = 1015) or standard hospital food (control group; n = 1013). To calculate the economic impact of nutritional support, a Markov model was developed with relevant health states. Costs were estimated for days in normal hospital ward and in the Intensive Care Unit (ICU), hospital-acquired complications, and nutritional support. We used a Euro conversion rate of 0.93216 Euro for 1 Swiss Franc (CHF).
RESULTS
The estimated per-patient cost was CHF90 (83.78 €) for the in-hospital nutritional support and CHF283.85 (264.23 €) when also considering dietitian consultation time. Overall costs of care within 30 days of admission averaged CHF29,263 (27,240 €) per-patient in the intervention group versus CHF29,477 (27,439 €) in the control group resulting in per-patient cost savings of CHF214 (199 €). Per-patient cost savings was CHF19.56 (18.21 €) when also accounting for dietician costs (full cost analysis). These cost savings were mainly due to reduced ICU length of stay and fewer complications. We also calculated costs to prevent adverse outcomes, which were CHF276 (256 €) for one severe complication, CHF2,675 (2490 €) for one day in ICU, and CHF7,975 (7423 €) for one death. For the full cost analysis, these numbers were CHF872 (811 €), CHF8,459 (7874 €) and CHF25,219 (23,475 €). Sensitivity analyses confirmed the original findings.
CONCLUSIONS
Our evaluation demonstrates that in-hospital nutritional support for medical inpatients is a highly cost-effective intervention to reduce risks for ICU admissions and hospital-associated complications, while improving patient survival. The positive clinical and economic benefits of nutritional support in at-risk medical inpatients calls for comprehensive nutrition programs, including malnutrition screening, consultation, and nutritional support.
TRIAL REGISTRATION
ClinicalTrials.gov number, NCT02517476.",2020,Per-patient cost savings was CHF19.56 (18.21 €) when also accounting for dietician costs (full cost analysis).,"['1 Swiss Franc (CHF', '2028 medical inpatients at nutritional risk', 'medical inpatients', 'medical inpatients at malnutrition risk']","['CHF29,477', 'individualized nutritional support to reach protein and energy goals (intervention group; n\xa0=\xa01015) or standard hospital food (control group; n\xa0=\xa01013']","['cost savings', 'Per-patient cost savings', 'Overall costs of care', 'ICU length of stay and fewer complications']","[{'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}]","[{'cui': 'C0242739', 'cui_str': 'Nutritional Support'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",2028.0,0.0699122,Per-patient cost savings was CHF19.56 (18.21 €) when also accounting for dietician costs (full cost analysis).,"[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Medical University Department, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty, University of Basel, Basel, Switzerland. Electronic address: schuetzph@gmail.com.'}, {'ForeName': 'Suela', 'Initials': 'S', 'LastName': 'Sulo', 'Affiliation': 'Abbott Nutrition, Chicago, IL, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Walzer', 'Affiliation': 'MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany; State University Baden-Wuerttemberg, Loerrach, Germany; University of Applied Sciences Ravensburg-Weingarten, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vollmer', 'Affiliation': 'MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany; University of Tuebingen, Germany.'}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Stanga', 'Affiliation': 'Medical University Department, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Gomes', 'Affiliation': 'Medical Faculty, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rueda', 'Affiliation': 'Abbott Nutrition, Granada, Spain.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Medical University Department, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Partridge', 'Affiliation': 'Abbott Nutrition, Chicago, IL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.02.023']
480,32149745,Functional Outcomes Associated With Adjacent-level Ossification Disease 10 Years After Cervical Disc Arthroplasty or ACDF.,"STUDY DESIGN
A retrospective review of a prospective, randomized control Food and Drug Administration (FDA) investigational device exemption trial comparing anterior cervical discectomy and fusion (ACDF) with Bryan cervical disc arthroplasty.
OBJECTIVE
Determine the clinical significance of adjacent-level ossification disease (ALOD) on long-term functional outcomes after ACDF or arthroplasty.
SUMMARY OF BACKGROUND DATA
ALOD occurs when the anterior longitudinal ligament and annulus adjacent to the index surgical level calcifies. As previously reported, ALOD happens more commonly after an arthrodesis than an arthroplasty. No investigation has previously examined 10-year clinical outcomes associated with ALOD.
MATERIALS AND METHODS
Forty patients were included in the 10-year follow-up. The index level was radiographically blinded and the cephalad-adjacent level was evaluated for ALOD. These scores underwent statistical analysis to compare the 2 surgical groups (ACDF and arthroplasty) for differences in the development of ALOD at a decade follow-up. Two investigational groups, on the basis of a high or low ALOD score, then proceeded through statistical analysis to compare the functional outcomes of patients in each group.
RESULTS
Statistical evaluation of ALOD findings in patients from each surgical group found a significantly higher rate of high-grade ALOD in patients who underwent cervical arthrodesis with plate fixation compared with cervical arthroplasty (68.2% vs. 11.1%, P=0.0003). Functional outcomes of patients were also assessed at the 10-year mark and outcomes in patients with either high-grade or low-grade ALOD were compared. When stratified by high versus low-grade ALOD, no significant difference was found for Neck Disability Index (NDI) (P=0.6431), VAS-arm (P=0.4497), or VAS-neck (P=0.8700) scores between groups.
CONCLUSIONS
The present study suggests that there are no significant long-term functional outcome differences between patients with and without significant ALOD. Our findings suggest ALOD may be a radiographic finding that does not alter patient-reported outcomes.
LEVEL OF EVIDENCE
Level III-therapeutic.",2020,"When stratified by high versus low-grade ALOD, no significant difference was found for Neck Disability Index (NDI) (P=0.6431), VAS-arm (P=0.4497), or VAS-neck (P=0.8700) scores between groups.
","['Forty patients were included in the 10-year follow-up', 'Adjacent-level Ossification Disease 10 Years']","['Cervical Disc Arthroplasty or ACDF', 'anterior cervical discectomy and fusion (ACDF) with Bryan cervical disc arthroplasty']","['rate of high-grade ALOD', 'Neck Disability Index (NDI', 'VAS-neck']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C4552416', 'cui_str': 'Anterior cervical discectomy with fusion'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C0206078', 'cui_str': 'Diskectomy'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}]","[{'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",40.0,0.0751951,"When stratified by high versus low-grade ALOD, no significant difference was found for Neck Disability Index (NDI) (P=0.6431), VAS-arm (P=0.4497), or VAS-neck (P=0.8700) scores between groups.
","[{'ForeName': 'Barrett S', 'Initials': 'BS', 'LastName': 'Boody', 'Affiliation': 'Indiana Spine Group, Indianapolis, IN.'}, {'ForeName': 'Evan N', 'Initials': 'EN', 'LastName': 'Lee', 'Affiliation': 'Indiana Spine Group, Indianapolis, IN.'}, {'ForeName': 'Willa R', 'Initials': 'WR', 'LastName': 'Sasso', 'Affiliation': 'Indiana Spine Group, Indianapolis, IN.'}, {'ForeName': 'Sheetal', 'Initials': 'S', 'LastName': 'Vinayek', 'Affiliation': 'Indiana Spine Group, Indianapolis, IN.'}, {'ForeName': 'Jaclyn M', 'Initials': 'JM', 'LastName': 'Demeter', 'Affiliation': 'Indiana Spine Group, Indianapolis, IN.'}, {'ForeName': 'Rick C', 'Initials': 'RC', 'LastName': 'Sasso', 'Affiliation': 'Indiana Spine Group, Indianapolis, IN.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Smucker', 'Affiliation': 'Indiana Spine Group, Indianapolis, IN.'}]",Clinical spine surgery,['10.1097/BSD.0000000000000954']
481,31743934,Evaluating a digital sepsis alert in a London multisite hospital network: a natural experiment using electronic health record data.,"OBJECTIVE
The study sought to determine the impact of a digital sepsis alert on patient outcomes in a UK multisite hospital network.
MATERIALS AND METHODS
A natural experiment utilizing the phased introduction (without randomization) of a digital sepsis alert into a multisite hospital network. Sepsis alerts were either visible to clinicians (patients in the intervention group) or running silently and not visible (the control group). Inverse probability of treatment-weighted multivariable logistic regression was used to estimate the effect of the intervention on individual patient outcomes.
OUTCOMES
In-hospital 30-day mortality (all inpatients), prolonged hospital stay (≥7 days) and timely antibiotics (≤60 minutes of the alert) for patients who alerted in the emergency department.
RESULTS
The introduction of the alert was associated with lower odds of death (odds ratio, 0.76; 95% confidence interval [CI], 0.70-0.84; n = 21 183), lower odds of prolonged hospital stay ≥7 days (OR, 0.93; 95% CI, 0.88-0.99; n = 9988), and in patients who required antibiotics, an increased odds of receiving timely antibiotics (OR, 1.71; 95% CI, 1.57-1.87; n = 4622).
DISCUSSION
Current evidence that digital sepsis alerts are effective is mixed. In this large UK study, a digital sepsis alert has been shown to be associated with improved outcomes, including timely antibiotics. It is not known whether the presence of alerting is responsible for improved outcomes or whether the alert acted as a useful driver for quality improvement initiatives.
CONCLUSIONS
These findings strongly suggest that the introduction of a network-wide digital sepsis alert is associated with improvements in patient outcomes, demonstrating that digital based interventions can be successfully introduced and readily evaluated.",2020,"The introduction of the alert was associated with lower odds of death (odds ratio, 0.76; 95% confidence interval [CI], 0.70-0.84; n = 21 183), lower odds of prolonged hospital stay ≥7 days (OR, 0.93; 95% CI, 0.88-0.99; n = 9988), and in patients who required antibiotics, an increased odds of receiving timely antibiotics (OR, 1.71; 95% CI, 1.57-1.87; n = 4622).
",[],[],"['odds of receiving timely antibiotics', 'prolonged hospital stay (≥7 days) and timely antibiotics']",[],[],"[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.183604,"The introduction of the alert was associated with lower odds of death (odds ratio, 0.76; 95% confidence interval [CI], 0.70-0.84; n = 21 183), lower odds of prolonged hospital stay ≥7 days (OR, 0.93; 95% CI, 0.88-0.99; n = 9988), and in patients who required antibiotics, an increased odds of receiving timely antibiotics (OR, 1.71; 95% CI, 1.57-1.87; n = 4622).
","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Honeyford', 'Affiliation': 'Global Digital Health Unit, Department of Primary Care and Public Health, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Graham S', 'Initials': 'GS', 'LastName': 'Cooke', 'Affiliation': 'Infectious Diseases Section, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kinderlerer', 'Affiliation': ""St Mary's Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Williamson', 'Affiliation': 'Electronic Health Records Research Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gilchrist', 'Affiliation': 'Department of Infectious Diseases, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Holmes', 'Affiliation': 'Health Protection Research Unit, Imperial College London, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Glampson', 'Affiliation': 'Department of Research Informatics, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Abdulrahim', 'Initials': 'A', 'LastName': 'Mulla', 'Affiliation': 'Department of Research Informatics, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Ceire', 'Initials': 'C', 'LastName': 'Costelloe', 'Affiliation': 'Global Digital Health Unit, Department of Primary Care and Public Health, Imperial College London, London, United Kingdom.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz186']
482,31365044,Effect of Adjunctive Estradiol on Schizophrenia Among Women of Childbearing Age: A Randomized Clinical Trial.,"Importance
Several lines of evidence suggest that estradiol influences the course of schizophrenia, and a previous randomized controlled trial demonstrated that transdermal estradiol improved symptoms in female patients of childbearing age. However, many initial positive findings in schizophrenia research are not later replicated.
Objective
To independently replicate the results of the effect of estradiol on schizophrenia in women of childbearing age.
Design, Setting, and Participants
An 8-week randomized, placebo-controlled trial performed in the Republic of Moldova between December 4, 2015, and July 29, 2016, among 200 premenopausal women aged 19 to 46 years with schizophrenia or schizoaffective disorder as defined by the DSM-5.
Intervention
Patients were randomized to receive a 200-μg estradiol patch or placebo patch changed twice a week added to their antipsychotic treatment.
Main Outcomes and Measures
The primary outcome was the positive subscale of the Positive and Negative Syndrome Scale (PANSS; lower scores indicated fewer symptoms and higher scores indicated more symptoms), analyzed with mixed models for repeated measures on an intention-to-treat basis.
Results
A total of 100 women (median age, 38 years; interquartile range, 34-42 years) were randomized to receive an estradiol patch and 100 women (median age, 38 years; interquartile range, 31-41 years) were randomized to receive a placebo patch; the median age at baseline for the entire group of 200 women was 38.0 years (range, 19.5-46.0 years). At baseline, the mean positive PANSS score was 19.6 for both groups combined; at week 8, the mean positive PANSS score was 14.4 in the placebo group and 13.4 in the estradiol group. Compared with placebo, participants receiving add-on estradiol patches had statistically significant improvements in the primary outcome measure, PANSS positive subscale points (-0.94; 95% CI, -1.64 to -0.24; P = .008; effect size = 0.38). Post hoc heterogeneity analyses found that this effect occurred almost entirely in 100 participants older than 38.0 years (46 in placebo group vs 54 in estradiol group; difference, -1.98 points on the PANSS positive subscale; 95% CI, -2.94 to -1.02; P < .001). Younger participants did not benefit from estradiol (difference, 0.08 points on the PANSS positive subscale; 95% CI, -0.91 to 1.07; P = .87). Breast tenderness was more common in the estradiol group (n = 15) than in the placebo group (n = 1) as was weight gain (14 in estradiol group vs 1 in placebo group).
Conclusions and Relevance
The results independently replicate the finding that transdermal estradiol is an effective add-on treatment for women of childbearing age with schizophrenia and extend it, finding improvements in negative symptoms and finding that the effect could be specific to those older than 38 years. The results should be viewed in the context of the differences in the natural course of schizophrenia between females and males.
Trial Registration
ClinicalTrials.gov identifier: NCT03848234.",2019,"Compared with placebo, participants receiving add-on estradiol patches had statistically significant improvements in the primary outcome measure, PANSS positive subscale points (-0.94; 95% CI, -1.64 to -0.24; P = .008; effect size = 0.38).","['women of childbearing age', 'female patients of childbearing age', '100 participants older than 38.0 years (46 in', 'controlled trial performed in the Republic of Moldova between December 4, 2015, and July 29, 2016, among 200 premenopausal women aged 19 to 46 years with schizophrenia or schizoaffective disorder as defined by the DSM-5', '100 women (median age, 38 years; interquartile range, 34-42 years', 'Schizophrenia Among Women of Childbearing Age', 'and 100 women (median age, 38 years; interquartile range, 31-41 years', 'women of childbearing age with schizophrenia', 'the median age at baseline for the entire group of 200 women was 38.0 years (range, 19.5-46.0 years']","['transdermal estradiol', '200-μg estradiol patch or placebo patch changed twice a week added to their antipsychotic treatment', 'estradiol', 'placebo', 'placebo patch', 'estradiol patch', 'Adjunctive Estradiol']","['Breast tenderness', 'mean positive PANSS score', 'weight gain', 'positive subscale of the Positive and Negative Syndrome Scale', 'PANSS positive subscale points']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0026374', 'cui_str': 'Moldavian S.S.R.'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0262397', 'cui_str': 'Breast tenderness (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",100.0,0.6327,"Compared with placebo, participants receiving add-on estradiol patches had statistically significant improvements in the primary outcome measure, PANSS positive subscale points (-0.94; 95% CI, -1.64 to -0.24; P = .008; effect size = 0.38).","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weiser', 'Affiliation': 'Stanley Medical Research Institute, Kensington, Maryland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Levi', 'Affiliation': 'Department of Psychiatry, Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Zamora', 'Affiliation': 'Department of Psychiatry, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Biegon', 'Affiliation': 'Department of Radiology, Stony Brook University Medical School, Stony Brook, New York.'}, {'ForeName': 'John Paul', 'Initials': 'JP', 'LastName': 'SanGiovanni', 'Affiliation': 'Section on Nutritional Neuroscience, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Department of Psychiatry, Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Shimon', 'Initials': 'S', 'LastName': 'Burshtein', 'Affiliation': 'Department of Psychiatry, Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Gonen', 'Affiliation': 'Tangent Alzheimer Care, Breaza, Romania.'}, {'ForeName': 'Paull', 'Initials': 'P', 'LastName': 'Radu', 'Affiliation': 'Tangent Alzheimer Care, Breaza, Romania.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Slobozean Pavalache', 'Affiliation': 'Republican Psychiatric Hospital, Chișinău, Moldova.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Nastas', 'Affiliation': 'Psychiatry, Narcology, and Medical Psychology, State University of Medicine and Pharmaceuticals, ""Nicolae Testemianu,"" Chisinau, Moldova.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hemi', 'Affiliation': 'Institute of Endocrinology, Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Ryan', 'Affiliation': 'Department of Psychiatry, University of Illinois, Chicago.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Department of Psychiatry, University of Illinois, Chicago.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.1842']
483,32150701,Effect of continuous cooling on inhibition and attention while wearing firefighter's PPE in a hot environment.,"Firefighting is physically and mentally strenuous, requiring rapid, appropriate decision-making in hot environments. Intact cognitive function is imperative to firefighters' effectiveness and safety. The study purpose was to investigate the effect of hyperthermia and the effect of body cooling on sustained attention and response inhibition while wearing firefighters' personal protective ensembles after exercise in a hot environment. Twelve healthy males were recruited to participate in two randomly assigned exercise sessions (walking on a treadmill for 40 min at 40% [Formula: see text] O 2max while wearing firefighter's protective ensemble) in a hot environment: control (no cooling) and intervention (cooling). For intervention sessions, a cooling garment was worn underneath firefighter's protective ensemble and infused with 18 °C water supplied by an external water circulator. Participants performed a computerized Go/No-Go (a measure of cognitive function) test three times at baseline and post-exercise for each experimental session. Participants completed baseline testing while wearing cotton athletic clothing. The exercise continued until the core temperature reached ∼39 °C (for all subjects regardless of cooling or non-cooling experimental sessions). Following hyperthermia, participants' physiological responses were significantly increased after exercise. Subjects' reaction time was significantly reduced (improved) after experiencing thermal strain and reaching hyperthermia. The cooling method had a significant impact on suppressing the physiological load, i.e., body cooling delayed the time to reach a T c of 39 °C (p ≤ 0.05), but not cognitive inhibition and attention (reaction time and accuracy). Unexpectedly, hyperthermia resulted in shorter reaction time following exercise (16.64 ± 5.62; p < 0.03), likely influenced by increased attention/vigilance. Hyperthermia may trigger an acute increase in alertness, causing decreased reaction time.",2020,"Unexpectedly, hyperthermia resulted in shorter reaction time following exercise (16.64 ± 5.62; p < 0.03), likely influenced by increased attention/vigilance.",['Twelve healthy males'],"['exercise sessions (walking on a treadmill for 40\u2009min at 40% [Formula: see text', 'continuous cooling', 'body cooling']","[""Subjects' reaction time"", 'attention/vigilance', 'cognitive inhibition and attention (reaction time and accuracy', 'shorter reaction time']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0412808', 'cui_str': 'Active cooling of patient (procedure)'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",12.0,0.063323,"Unexpectedly, hyperthermia resulted in shorter reaction time following exercise (16.64 ± 5.62; p < 0.03), likely influenced by increased attention/vigilance.","[{'ForeName': 'Ali M', 'Initials': 'AM', 'LastName': 'Aljaroudi', 'Affiliation': 'National Personal Protective Technology Laboratory (NPPTL), National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), Pittsburgh, Pennsylvania.'}, {'ForeName': 'Darren S', 'Initials': 'DS', 'LastName': 'Kadis', 'Affiliation': ""Division of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bhattacharya', 'Affiliation': 'Department of Environmental Health, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Strauch', 'Affiliation': 'National Personal Protective Technology Laboratory (NPPTL), National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), Pittsburgh, Pennsylvania.'}, {'ForeName': 'Tyler D', 'Initials': 'TD', 'LastName': 'Quinn', 'Affiliation': 'National Personal Protective Technology Laboratory (NPPTL), National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), Pittsburgh, Pennsylvania.'}, {'ForeName': 'W Jon', 'Initials': 'WJ', 'LastName': 'Williams', 'Affiliation': 'National Personal Protective Technology Laboratory (NPPTL), National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), Pittsburgh, Pennsylvania.'}]",Journal of occupational and environmental hygiene,['10.1080/15459624.2020.1726933']
484,32069067,"Efficacy of Insulclock in Patients with Poorly Controlled Type 1 Diabetes Mellitus: A Pilot, Randomized Clinical Trial.","Insulclock ® is an electronic device designed to improve treatment adherence and insulin injection tracking. This randomized, single-center, pilot study assessed the clinical impact of Insulclock on glycemic control and variability, treatment adherence, and satisfaction in patients with uncontrolled type 1 diabetes mellitus (T1DM). We also compared these outcomes between the Active and Masked groups (with or without receiving reminders and app alerts). Sixteen patients completed the study: 10 in the Active group and 6 in the Masked group. Insulclock use was associated with a decrease in mean glucose (-27.0 mg/dL [1.5 mmol/L]; P = 0.013), glucose standard deviation (-14.4 mg/dL [0.8 mmol/L]; P = 0.003), and time above range (-12.5%; P = 0.0026), and an increase in time in range (TIR) (+7%; P = 0.038) in the overall population. The use of app information and alerts in the Active group was associated with an increase in TIR (+8%; P = 0.026). We observed a -3.9 ( P = 0.1352) and -5.4 ( P = 0.032) reduction per month in the number of missed and mistimed insulin doses in the overall population, respectively. Most of the items of the Insulin Treatment Satisfaction Questionnaire (ITSQ) improved after 4 weeks of Insulclock use. This pilot study points out an improvement in glycemic levels, adherence, and satisfaction in T1DM patients, supporting the development of clinical trials powered to confirm these effects.",2020,Insulclock use was associated with a decrease in mean glucose (-27.0 mg/dL,"['patients with uncontrolled Type 1 diabetes mellitus (T1DM', 'patients with poorly controlled type 1 diabetes mellitus', 'Sixteen patients completed the study: ten in the Active group and six in the Masked group']",['Insulclock'],"['time above range (TAR', 'glucose standard deviation (SD', 'mean glucose', 'TIR', 'time in range (TIR', 'Insulin Treatment Satisfaction Questionnaire (ITSQ', 'glycemic levels, adherence and satisfaction', 'glycemic control and variability, treatment adherence and satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3887664', 'cui_str': 'Tars, topical antipsoriatics'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}]",16.0,0.0771619,Insulclock use was associated with a decrease in mean glucose (-27.0 mg/dL,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Gomez-Peralta', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Abreu', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gomez-Rodriguez', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Cruz-Bravo', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'María-Sanchez', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Poza', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ruiz-Valdepeñas', 'Affiliation': 'Research and Development Unit, Insulcloud S.L. (B87131454), Madrid, Spain.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0427']
485,32152513,Effects of substituting eggs for high-carbohydrate breakfast foods on the cardiometabolic risk-factor profile in adults at risk for type 2 diabetes mellitus.,"OBJECTIVES
To assess effects of egg-based versus non-egg, higher-carbohydrate (CHO) breakfast meals on cardiometabolic health markers in overweight or obese adults with prediabetes and/or metabolic syndrome.
METHODS
This randomized, crossover study included two 4-week dietary interventions, separated by a ≥4-week washout. Subjects incorporated into their habitual diets breakfast meals containing either 2 eggs/day for 6 days/week (Egg condition), or energy-matched, non-egg, higher-CHO-based foods (Non-Egg condition). Dietary intakes, insulin sensitivity, and other CHO metabolism indices, lipid biomarkers, high-sensitivity C-reactive protein, and blood pressures were measured.
RESULTS
Thirty men and women with mean age 54.1 ± 1.9 years and body mass index 31.9 ± 0.7 kg/m 2 provided data. Neither diet condition significantly altered insulin sensitivity indices, but the homeostasis model assessment for insulin resistance was significantly (p = 0.028) higher after the Non-Egg vs. the Egg condition. Low-density lipoprotein cholesterol (LDL-C) was decreased from baseline (119 mg/dL) by 2.9 and 6.0% with Egg and Non-Egg breakfasts, respectively (p = 0.023). Systolic blood pressure was reduced from baseline (127 mm Hg) by 2.7 and 0.0% with Egg and Non-Egg, respectively (p = 0.018). Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
CONCLUSION
Compared with the baseline diet, consumption of 12 eggs/week for 4 weeks at breakfast was associated with less reduction in LDL-C, and more lowering of systolic blood pressure, than observed with non-egg-based, energy-matched, control foods higher in CHO.",2020,"Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
","['overweight or obese adults with prediabetes and/or metabolic syndrome', 'Thirty men and women with mean age 54.1\u2009±\u20091.9\u2009years and body mass index 31.9\u2009±\u20090.7\u2009kg/m 2 provided data', 'adults at risk for type 2 diabetes mellitus']","['egg-based versus non-egg, higher-carbohydrate (CHO) breakfast meals']","['lowering of systolic blood pressure', 'Systolic blood pressure', 'Low-density lipoprotein cholesterol (LDL-C', 'Dietary intakes, insulin sensitivity, and other CHO metabolism indices, lipid biomarkers, high-sensitivity C-reactive protein, and blood pressures', 'weight change', 'cardiometabolic risk-factor profile', 'insulin sensitivity indices', 'homeostasis model assessment for insulin resistance', 'cardiometabolic health markers']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0693838,"Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA. kmaki@mbclinicalresearch.com.'}, {'ForeName': 'Orsolya M', 'Initials': 'OM', 'LastName': 'Palacios', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}, {'ForeName': 'Melvyn W', 'Initials': 'MW', 'LastName': 'Kramer', 'Affiliation': 'MB Clinical Research, Boca Raton, FL, USA.'}, {'ForeName': 'Rupal', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'Great Lakes Clinical Trials, Chicago, IL, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Wilcox', 'Affiliation': 'MB Clinical Research, Boca Raton, FL, USA.'}, {'ForeName': 'Cathleen E', 'Initials': 'CE', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0599-2']
486,31586510,Sugar-Sweetened Beverage Health Warnings and Purchases: A Randomized Controlled Trial.,"INTRODUCTION
Five U.S. states have proposed policies to require health warnings on sugar-sweetened beverages, but warnings' effects on actual purchase behavior remain uncertain. This study evaluated the impact of sugar-sweetened beverage health warnings on sugar-sweetened beverage purchases.
STUDY DESIGN
Participants completed one study visit to a life-sized replica of a convenience store in North Carolina. Participants chose six items (two beverages, two foods, and two household products). One item was randomly selected for them to purchase and take home. Participants also completed a questionnaire. Researchers collected data in 2018 and conducted analyses in 2019.
SETTING/PARTICIPANTS
Participants were a demographically diverse convenience sample of 400 adult sugar-sweetened beverage consumers (usual consumption ≥12 ounces/week).
INTERVENTION
Research staff randomly assigned participants to a health warning arm (sugar-sweetened beverages in the store displayed a front-of-package health warning) or a control arm (sugar-sweetened beverages displayed a control label).
MAIN OUTCOME MEASURES
The primary trial outcome was sugar-sweetened beverage calories purchased. Secondary outcomes included reactions to trial labels (e.g., negative emotions) and sugar-sweetened beverage perceptions and attitudes (e.g., healthfulness).
RESULTS
All 400 participants completed the trial and were included in analyses. Health warning arm participants were less likely to be Hispanic and to have overweight/obesity than control arm participants. In intent-to-treat analyses adjusting for Hispanic ethnicity and overweight/obesity, health warnings led to lower sugar-sweetened beverage purchases (adjusted difference, -31.4 calories; 95% CI= -57.9, -5.0). Unadjusted analyses yielded similar results (difference, -32.9 calories; 95% CI= -58.9, -7.0). Compared with the control label, sugar-sweetened beverage health warnings also led to higher intentions to limit sugar-sweetened beverage consumption and elicited more attention, negative emotions, thinking about the harms of sugar-sweetened beverage consumption, and anticipated social interactions. Trial arms did not differ on perceptions of sugar-sweetened beverages' added sugar content, healthfulness, appeal/coolness, or disease risk.
CONCLUSIONS
Brief exposure to health warnings reduced sugar-sweetened beverage purchases in this naturalistic RCT. Sugar-sweetened beverage health warning policies could discourage sugar-sweetened beverage consumption.
TRIAL REGISTRATION
This study is registered at www.clinicaltrials.gov NCT03511937.",2019,"Compared with the control label, sugar-sweetened beverage health warnings also led to higher intentions to limit sugar-sweetened beverage consumption and elicited more attention, negative emotions, thinking about the harms of sugar-sweetened beverage consumption, and anticipated social interactions.","['All 400 participants completed the trial and were included in analyses', '2018 and conducted analyses in 2019', 'Participants completed one study visit to a life-sized replica of a convenience store in North Carolina', 'Participants were a demographically diverse convenience sample of 400 adult sugar-sweetened beverage consumers (usual consumption ≥12 ounces/week']","['Sugar-Sweetened Beverage Health Warnings and Purchases', 'health warning arm (sugar-sweetened beverages in the store displayed a front-of-package health warning) or a control arm (sugar-sweetened beverages displayed a control label']","[""perceptions of sugar-sweetened beverages' added sugar content, healthfulness, appeal/coolness, or disease risk"", 'sugar-sweetened beverage calories purchased', 'reactions to trial labels (e.g., negative emotions) and sugar-sweetened beverage perceptions and attitudes (e.g., healthfulness']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0556977', 'cui_str': 'oz/week'}]","[{'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",400.0,0.148836,"Compared with the control label, sugar-sweetened beverage health warnings also led to higher intentions to limit sugar-sweetened beverage consumption and elicited more attention, negative emotions, thinking about the harms of sugar-sweetened beverage consumption, and anticipated social interactions.","[{'ForeName': 'Anna H', 'Initials': 'AH', 'LastName': 'Grummon', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, North Carolina; Carolina Population Center, University of North Carolina Chapel Hill, Chapel Hill, North Carolina. Electronic address: agrummon@unc.edu.'}, {'ForeName': 'Lindsey S', 'Initials': 'LS', 'LastName': 'Taillie', 'Affiliation': 'Carolina Population Center, University of North Carolina Chapel Hill, Chapel Hill, North Carolina; Department of Nutrition, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Shelley D', 'Initials': 'SD', 'LastName': 'Golden', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, North Carolina; Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, North Carolina; Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Ranney', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of North Carolina Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina Chapel Hill, Chapel Hill, North Carolina; Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, Chapel Hill, North Carolina.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.06.019']
487,32147197,"Vegan diet reduces neutrophils, monocytes and platelets related to branched-chain amino acids - A randomized, controlled trial.","BACKGROUND
Vegan diet (VD) has improved inflammatory activity in patients with rheumatoid arthritis (RA) in several small controlled trials. The underlying mechanism remains widely unclear. We investigated the effect of a VD in comparison to a meat-rich diet (MD) on markers of inflammation (which have been shown to be relevant in patients with RA) in healthy volunteers.
METHODS
53 healthy, omnivore subjects were randomized to a controlled VD (n = 26) or MD (n = 27) for 4 weeks following a pre-treatment phase of a one week controlled mixed diet. Primary parameters of interest were sialylation of immunoglobulins, percentage of regulatory T-cells and level of interleukin 10 (IL10). Usual care immune parameters used in patients with RA and amino acid serum levels as well as granulocytes and monocytes colony stimulating factor (GM-CSF) serum levels were secondary parameters.
RESULTS
In the VD group, total leukocyte, neutrophil, monocyte and platelet counts decreased and after four weeks they were significantly lower compared to the MD group (ANCOVA: leukocytes p = 0.003, neutrophils p = 0.001, monocytes p = 0.032, platelets p = 0.004). Leukocytes, neutrophils, monocytes, and platelets correlated with each other and likewise conform with serum levels of branched-chain amino acids, which were significantly lower in the VD compared to the MD group. The primary parameters did not differ between the groups and BMI remained stable in the two groups.
CONCLUSION
Four weeks of a controlled VD affected the number of neutrophils, monocytes and platelets but not the number or function of lymphocytes. The relation with branched-chain amino acids and GM-CSF suggests a mode of action via the mTOR signaling pathway. REGISTERED AT: http://www.drks.de (German Clinical Trial register) at DRKS00011963.",2020,"In the VD group, total leukocyte, neutrophil, monocyte and platelet counts decreased and after four weeks they were significantly lower compared to the MD group (ANCOVA: leukocytes","['patients with rheumatoid arthritis (RA', '53 healthy, omnivore subjects', 'patients with RA) in healthy volunteers']","['meat-rich diet (MD', 'MD', 'Vegan diet (VD', 'Vegan diet']","['sialylation of immunoglobulins, percentage of regulatory T-cells and level of interleukin 10 (IL10', 'total leukocyte, neutrophil, monocyte and platelet counts', 'Leukocytes, neutrophils, monocytes, and platelets', 'number or function of lymphocytes', 'granulocytes and monocytes colony stimulating factor (GM-CSF) serum levels', 'number of neutrophils, monocytes and platelets', 'inflammatory activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0562693', 'cui_str': 'Omnivore (organism)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0344353', 'cui_str': 'Vegan dietary (finding)'}]","[{'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",53.0,0.0396375,"In the VD group, total leukocyte, neutrophil, monocyte and platelet counts decreased and after four weeks they were significantly lower compared to the MD group (ANCOVA: leukocytes","[{'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Lederer', 'Affiliation': 'Center for Complementary Medicine, Institute for Infection Prevention and Hospital Epidemiology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. Electronic address: ann.kathrin.lederer@uniklinik-freiburg.de.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Maul-Pavicic', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany; Center of Chronic Immunodeficiency (CCI), Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Hannibal', 'Affiliation': 'Laboratory of Clinical Biochemistry and Metabolism, Department for Pediatrics, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Hettich', 'Affiliation': 'Center for Complementary Medicine, Institute for Infection Prevention and Hospital Epidemiology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Steinborn', 'Affiliation': 'Center for Complementary Medicine, Institute for Infection Prevention and Hospital Epidemiology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Gründemann', 'Affiliation': 'Translational Complementary Medicine, Department of Pharmaceutical Sciences, University of Basel, Klingelbergstr. 50, 4056 Basel, Switzerland.'}, {'ForeName': 'Amy Marisa', 'Initials': 'AM', 'LastName': 'Zimmermann-Klemd', 'Affiliation': 'Center for Complementary Medicine, Institute for Infection Prevention and Hospital Epidemiology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Müller', 'Affiliation': 'Center for Complementary Medicine, Institute for Infection Prevention and Hospital Epidemiology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Sehnert', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany; Center of Chronic Immunodeficiency (CCI), Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Salzer', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany; Center of Chronic Immunodeficiency (CCI), Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Reinhild', 'Initials': 'R', 'LastName': 'Klein', 'Affiliation': 'Department of Internal Medicine II, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Reinhard E', 'Initials': 'RE', 'LastName': 'Voll', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany; Center of Chronic Immunodeficiency (CCI), Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Samstag', 'Affiliation': 'Institute of Immunology, Section Molecular Immunology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Huber', 'Affiliation': 'Center for Complementary Medicine, Institute for Infection Prevention and Hospital Epidemiology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.02.011']
488,31577341,Efficacy and Safety of Oral Janus Kinase 1 Inhibitor Abrocitinib for Patients With Atopic Dermatitis: A Phase 2 Randomized Clinical Trial.,"Importance
Atopic dermatitis is associated with substantial patient and caregiver burden. Currently available treatments for atopic dermatitis are inadequate or contraindicated for some patients. Abrocitinib (PF-04965842) is an oral Janus kinase 1 selective inhibitor under investigation for the treatment of atopic dermatitis.
Objective
To investigate the efficacy and safety of abrocitinib for patients with moderate to severe atopic dermatitis.
Design, Setting, and Participants
A phase 2b, randomized, double-blinded, placebo-controlled, parallel-group trial was conducted from April 15, 2016, to April 4, 2017, at 58 centers in Australia, Canada, Germany, Hungary, and the United States among 267 patients 18 to 75 years of age with a clinical diagnosis of moderate to severe atopic dermatitis for 1 year or more and inadequate response or contraindication to topical medications for 4 weeks or more within 12 months. Efficacy was assessed in the full analysis set, which was a modified intention-to-treat population that included all patients who received 1 dose or more of the study drug except for 4 patients from 1 site.
Interventions
Participants were randomly assigned 1:1:1:1:1 to receive abrocitinib (200 mg, 100 mg, 30 mg, or 10 mg) or placebo once daily for 12 weeks.
Main Outcomes and Measures
The primary outcome was the proportion of patients achieving an Investigator's Global Assessment of clear (0) or almost clear (1) with an improvement from baseline of 2 grades or more at week 12. The secondary outcome was the percentage change from baseline in the Eczema Area and Severity Index at week 12.
Results
Of the 267 participants, 144 were women (mean [SD] age, 40.8 [16.1] years). At week 12, 21 of 48 patients receiving 200 mg of abrocitinib (43.8%; P < .001, 2-sided), 16 of 54 patients receiving 100 mg of abrocitinib (29.6%; P < .001), and 3 of 52 patients receiving placebo (5.8%) achieved grades of clear or almost clear on the Investigator's Global Assessment scale with improvement of 2 grades or more; these rates correspond to maximum effect model-based estimates of 44.5% (95% CI, 26.7%-62.3%) for those receiving 200 mg of abrocitinib, 27.8% (95% CI, 14.8%-40.9%) for those receiving 100 mg of abrocitinib, and 6.3% (95% CI, -0.2% to 12.9%) for those receiving placebo. Reductions in the Eczema Area and Severity Index were 82.6% (90% CI, 72.4%-92.8%; P < .001) for those receiving 200 mg of abrocitinib, 59.0% (90% CI, 48.8%-69.3%; P = .009) for those receiving 100 mg of abrocitinib, and 35.2% (90% CI, 24.4%-46.1%) for those receiving placebo. Adverse events were observed in 184 of 267 patients (68.9%); the most frequently reported adverse events (in ≥3 patients in any group) were dermatitis atopic, upper respiratory tract infection, headache, nausea, and diarrhea. Dose-dependent decreases in platelet count were observed but trended upward toward baseline levels after week 4.
Conclusions and Relevance
Once-daily oral abrocitinib was effective and well tolerated for short-term use in adults with moderate to severe atopic dermatitis. Additional trials are necessary to evaluate long-term efficacy and safety.
Trial Registration
ClinicalTrials.gov identifier: NCT02780167.",2019,"Reductions in the Eczema Area and Severity Index were 82.6% (90% CI, 72.4%-92.8%; P < .001) for those receiving 200 mg of abrocitinib, 59.0% (90% CI, 48.8%-69.3%;","['adults with moderate to severe atopic dermatitis', 'Patients With Atopic Dermatitis', '267 participants', 'patients with moderate to severe atopic dermatitis', 'April 15, 2016, to April 4, 2017, at 58 centers in Australia, Canada, Germany, Hungary, and the United States among 267 patients 18 to 75 years of age with a clinical diagnosis of moderate to severe atopic dermatitis for 1 year or more and inadequate response or contraindication to topical medications for 4 weeks or more within 12 months', '144 were women (mean [SD] age, 40.8 [16.1] years']","['placebo', 'Oral Janus Kinase 1 Inhibitor Abrocitinib', 'abrocitinib']","['adverse events', 'Adverse events', 'efficacy and safety', 'Efficacy', 'platelet count', 'percentage change from baseline in the Eczema Area and Severity Index', 'Efficacy and Safety', 'dermatitis atopic, upper respiratory tract infection, headache, nausea, and diarrhea', 'Eczema Area and Severity Index', ""Investigator's Global Assessment scale"", ""proportion of patients achieving an Investigator's Global Assessment of clear (0) or almost clear (1""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4319689', 'cui_str': 'Sixteen point one'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0169658', 'cui_str': 'Jak1 Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}]",144.0,0.596428,"Reductions in the Eczema Area and Severity Index were 82.6% (90% CI, 72.4%-92.8%; P < .001) for those receiving 200 mg of abrocitinib, 59.0% (90% CI, 48.8%-69.3%;","[{'ForeName': 'Melinda J', 'Initials': 'MJ', 'LastName': 'Gooderham', 'Affiliation': 'SKiN Centre for Dermatology, Peterborough, Ontario, Canada.'}, {'ForeName': 'Seth B', 'Initials': 'SB', 'LastName': 'Forman', 'Affiliation': 'Forward Clinical Trials, Tampa, Florida.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Department of Dermatology, Innovaderm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Beebe', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, New York.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Innovative Health Statistics, Pfizer Inc, New York, New York.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Banfield', 'Affiliation': 'Early Clinical Development Unit, Pfizer Inc, New York, New York.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Early Clinical Development Unit, Pfizer Inc, New York, New York.'}, {'ForeName': 'Jocelyne', 'Initials': 'J', 'LastName': 'Papacharalambous', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, New York.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Vincent', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, New York.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Peeva', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, New York.'}]",JAMA dermatology,['10.1001/jamadermatol.2019.2855']
489,30741854,Reimagining Health Communication: A Noninferiority Randomized Controlled Trial of Crowdsourced Intervention in China.,"BACKGROUND
Crowdsourcing, the process of shifting individual tasks to a large group, may be useful for health communication, making it more people-centered. We aimed to evaluate whether a crowdsourced video is noninferior to a social marketing video in promoting condom use.
METHODS
Men who have sex with men (≥16 years old, had condomless sex within 3 months) were recruited and randomly assigned to watch 1 of the 2 videos in 2015. The crowdsourced video was developed through an open contest, and the social marketing video was designed by using social marketing principles. Participants completed a baseline survey and follow-up surveys at 3 weeks and 3 months postintervention. The outcome was compared with a noninferiority margin of +10%.
RESULTS
Among the 1173 participants, 907 (77%) and 791 (67%) completed the 3-week and 3-month follow-ups. At 3 weeks, condomless sex was reported by 146 (33.6%) of 434 participants and 153 (32.3%) 473 participants in the crowdsourced and social marketing arms, respectively. The crowdsourced intervention achieved noninferiority (estimated difference, +1.3%; 95% confidence interval, -4.8% to 7.4%). At 3 months, 196 (52.1%) of 376 individuals and 206 (49.6%) of 415 individuals reported condomless sex in the crowdsourced and social-marketing arms (estimated difference: +2.5%, 95% confidence interval, -4.5 to 9.5%). The 2 arms also had similar human immunodeficiency virus testing rates and other condom-related secondary outcomes.
CONCLUSIONS
Our study demonstrates that crowdsourced message is noninferior to a social marketing intervention in promoting condom use among Chinese men who have sex with men. Crowdsourcing contests could have a wider reach than other approaches and create more people-centered intervention tools for human immunodeficiency virus control.",2019,"At 3 weeks, condomless sex was reported by 146 (33.6%) of 434 participants and 153 (32.3%) 473 participants in the crowdsourced and social marketing arms, respectively.","['Men who have sex with men (≥16 years old, had condomless sex within 3 months', 'Chinese men who have sex with men', 'China', '1173 participants, 907 (77%) and 791 (67%) completed the 3-week and 3-month follow-ups', 'Reimagining Health Communication']","['social marketing intervention', 'Crowdsourced Intervention']",['condomless sex'],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1512347', 'cui_str': 'Health Communication'}]","[{'cui': 'C0037424', 'cui_str': 'Social Marketing'}]","[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]",434.0,0.13762,"At 3 weeks, condomless sex was reported by 146 (33.6%) of 434 participants and 153 (32.3%) 473 participants in the crowdsourced and social marketing arms, respectively.","[{'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'SESH Study Group of University of North Carolina at Chapel Hill, Guangzhou, China.'}, {'ForeName': 'Chuncheng', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'SESH Study Group of University of North Carolina at Chapel Hill, Guangzhou, China.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Mollan', 'Affiliation': 'School of Medicine.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Songyuan', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hudgens', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'School of Public Health, Shandong University.'}, {'ForeName': 'Dianmin', 'Initials': 'D', 'LastName': 'Kang', 'Affiliation': 'Shandong Provincial Center for Disease Prevention and Control, Jinan, China.'}, {'ForeName': 'Chongyi', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Sc Rutgers University, Newark, NJ.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000000930']
490,31944893,Dental RECUR Randomized Trial to Prevent Caries Recurrence in Children.,"The purpose of this study was to determine the efficacy of a dental nurse-delivered intervention-the Dental RECUR Brief Negotiated Interview for Oral Health (DR-BNI)-in reducing the recurrence of dental caries in children who have a primary tooth extracted. It was based on a 2-arm multicenter randomized controlled trial with blinded outcome assessment. Participants were 5- to 7-y-old children ( n = 241) scheduled to have primary teeth extracted in 12 UK centers. Test intervention parents ( n = 119) received DR-BNI led by trained dental nurses. DR-BNI is a 30-min structured conversation informed by motivational interviewing with a forward focus to prevent future caries. Preventive goals are agreed, and a review appointment is made with child's general dental practitioner, who is advised to treat the child as being at high caries risk. The control intervention ( n = 122) was a parent-nurse conversation about child's future tooth eruption, with advice given to visit a general dental practitioner as usual. At baseline, the DR-BNI group's mean dmft was 6.8, and the control group's was 6.3. A median of 5 teeth were extracted, mainly under general anesthesia. Final dental assessments were conducted by a single examiner visiting 189 schools 2 y after intervention; 193 (80%) of 241 children were examined. In the control group, 62% developed new caries in teeth that were caries-free or unerupted at baseline, as compared with 44% in the test group, a significant reduction ( P = 0.021). The odds of new caries experience occurring were reduced by 51% in the DR-BNI group as compared with control. There was a 29% decrease in the relative risk of new caries experience in the DR-BNI group as compared with control. This single low-cost, low-intensity intervention was successful in significantly reducing the risk of recurrence of dental caries in children. This trial has implications for changing pediatric dental practice internationally. Training in and implementation of a motivational interviewing-informed brief intervention provides opportunities for dental nurses to facilitate behavior change improving the oral health of children at high caries risk (ISRCTN 24958829).",2020,The odds of new caries experience occurring were reduced by 51% in the DR-BNI group as compared with control.,"['children', 'children who have a primary tooth extracted', 'children at high caries risk (ISRCTN 24958829', 'Children', 'Participants were 5- to 7-y-old children ( n = 241) scheduled to have primary teeth extracted in 12 UK centers']","['DR-BNI led by trained dental nurses', 'motivational interviewing-informed brief intervention', 'control intervention', 'dental nurse-delivered intervention-the Dental RECUR Brief Negotiated Interview for Oral Health (DR-BNI)-in']","['risk of recurrence of dental caries', 'new caries', 'relative risk of new caries experience']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0969259', 'cui_str': ""bis(O,O'-di-p-tolyldithiophosphato-S,S')(1,10-phenanthroline-N,N')nickel(II)""}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0011327', 'cui_str': 'Nurses, Dental'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}, {'cui': 'C0029162'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",241.0,0.049632,The odds of new caries experience occurring were reduced by 51% in the DR-BNI group as compared with control.,"[{'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Pine', 'Affiliation': 'Research and Innovation, Salford Royal NHS Foundation Trust, Northern Care Alliance NHS Group, Summerfield House, Salford, UK.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Adair', 'Affiliation': ""Centre for Improving Health-Related Quality of Life, School of Psychology, Queen's University, Belfast, UK.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Burnside', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Brennan', 'Affiliation': 'Health Education North West, Regatta Place, Liverpool, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sutton', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Edwards', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ezeofor', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Albadri', 'Affiliation': 'Paediatric Dentistry, School of Dentistry, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Curnow', 'Affiliation': 'Public Dental Service, Broxden Dental Centre, NHS Tayside, Perth, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Deery', 'Affiliation': 'School of Clinical Dentistry, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Hosey', 'Affiliation': 'Paediatric Dentistry, Centre of Oral, Clinical and Translational Science, Faculty of Dentistry, Oral and Craniofacial Sciences, Kings College London, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Willis-Lake', 'Affiliation': 'Kent Community Health NHS Foundation Trust, Maidstone, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lynn', 'Affiliation': 'Community Dental Service, Arches Health and Care Centre, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Parry', 'Affiliation': 'Special Care Dental Service, Sussex Community NHS Foundation Trust, Brighton, UK.'}, {'ForeName': 'F S L', 'Initials': 'FSL', 'LastName': 'Wong', 'Affiliation': 'Barts and the London Schools of Medicine and Dentistry, Institute of Dentistry, Queen Mary University of London, London, UK.'}]",Journal of dental research,['10.1177/0022034519886808']
491,30821652,Qualitative identification and characterisation of self-reported symptoms arising in humans during experimental exposure to cold air.,"BACKGROUND
Exposure to cold air is associated with increased morbidity and mortality in the general population. It is difficult to study the effects of whole-body exposure to cold air under controlled conditions in real life.
OBJECTIVES
The aim of this study was to (1) explore and describe the experience of symptoms in humans during experimental and controlled exposures to cold air, by using controlled environmental chamber exposures and qualitative methodology, and to (2) categorise the symptoms.
METHOD
The study used a randomised, double blind design, in which 34 subjects undertook rest and moderate-intensity exercise in an environmental chamber set to two or three different temperatures (0, -10, and -17°C) on separate occasions. During the chamber exposures, subjects were interviewed. Qualitative content analysis was selected as the method of analysis.
FINDINGS
Subjects reported 50 distinct symptoms during the exposures. The symptoms were grouped into ten sub-categories and two major categories; airway versus whole-body symptoms.
CONCLUSION
We have identified a broad range of symptoms in humans undertaking rest and moderate-intensity exercise at sub-zero temperatures. The symptoms and their categories may well be used to more extensively and quantitatively map cold-induced morbidity.",2019,"FINDINGS
Subjects reported 50 distinct symptoms during the exposures.",['34 subjects undertook'],['rest and moderate-intensity exercise'],['morbidity and mortality'],"[{'cui': 'C0041666', 'cui_str': 'Undertaking'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",34.0,0.0390205,"FINDINGS
Subjects reported 50 distinct symptoms during the exposures.","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Sjöström', 'Affiliation': 'a Department of Community Medicine and Rehabilitation , Umeå University , Umeå , Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Söderström', 'Affiliation': 'b Unit of Research, Education and Development , Östersund Hospital , Östersund , Sweden.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Klockmo', 'Affiliation': 'c Research and Development Unit , Kommunförbundet Västernorrland , Härnösand , Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Patrician', 'Affiliation': 'd Swedish Winter Sports Research Centre, Department of Health Sciences , Mid Sweden University , Östersund , Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sandström', 'Affiliation': 'e Department of Public Health and Clinical Medicine, Medicine , Umeå University , Umeå , Sweden.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Björklund', 'Affiliation': 'd Swedish Winter Sports Research Centre, Department of Health Sciences , Mid Sweden University , Östersund , Sweden.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hanstock', 'Affiliation': 'd Swedish Winter Sports Research Centre, Department of Health Sciences , Mid Sweden University , Östersund , Sweden.'}, {'ForeName': 'Nikolai', 'Initials': 'N', 'LastName': 'Stenfors', 'Affiliation': 'e Department of Public Health and Clinical Medicine, Medicine , Umeå University , Umeå , Sweden.'}]",International journal of circumpolar health,['10.1080/22423982.2019.1583528']
492,31070471,"Group IIA Secretory Phospholipase A 2 , Vascular Inflammation, and Incident Cardiovascular Disease.","Objective- Inflammation is a causal risk factor for cardiovascular disease (CVD). sPLA 2 -IIA (group IIA secretory phospholipase A 2 ) plays an integral role in regulating vascular inflammation. Although studies investigated sPLA 2 -IIA in secondary prevention, we prospectively evaluated sPLA 2 -IIA mass and genetic variants with CVD events in a primary prevention population with chronic inflammation. Approach and Results- The JUPITER trial (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin) randomized participants with LDL (low-density lipoprotein) <130 mg/dL and hsCRP (high-sensitivity C-reactive protein) ≥2 mg/L to high-intensity rosuvastatin versus placebo. Baseline and 1-year plasma sPLA 2 -IIA mass was measured (N=11 269 baseline; N=9620 1 year). We also identified genetic variants influencing sPLA 2 -IIA using genome-wide association and examined them with CVD. Three hundred thirteen incident CVD events occurred during follow-up. Baseline sPLA 2 -IIA mass (median, 25th-75th percentile: 3.81, 2.49-6.03 ng/mL) was associated with increased risk of CVD: risk factor-adjusted hazard ratio (95% CI; P) per SD increment: 1.22 (1.08-1.38; P=0.002). This remained significant (1.18; 1.04-1.35; P=0.01) after incrementally adjusting for hsCRP. Similar estimates were observed in rosuvastatin and placebo groups ( P treatment interaction>0.05). The rs11573156C variant in PLA2G2A (encoding sPLA 2 -IIA) had the strongest effect on sPLA 2 -II: median (25th-75th percentile, ng/mL) for CC and GG genotypes: 2.79 (1.97-4.01) and 7.38 (5.38-10.19), respectively; and had nonsignificant trend for higher CVD risk (hazard ratio, 1.11; 95% CI, 0.89-1.38; P=0.34). Conclusions- In the JUPITER population recruited on chronic inflammation, sPLA 2 -IIA mass was associated with CVD risk relating to vascular inflammation not fully reflected by hsCRP. Additional studies, including larger functional genetic and clinical studies, are needed to determine whether sPLA 2 -IIA may be a potential pharmacological target for primary prevention of CVD. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT00239681.",2019,"The rs11573156C variant in PLA2G2A (encoding sPLA 2 -IIA) had the strongest effect on sPLA 2 -II: median (25th-75th percentile, ng/mL) for CC and GG genotypes: 2.79 (1.97-4.01) and 7.38 (5.38-10.19), respectively; and had nonsignificant trend for higher CVD risk (hazard ratio, 1.11; 95% CI, 0.89-1.38; P=0.34).",['participants with LDL (low-density lipoprotein) <130 mg/dL and hsCRP (high-sensitivity C-reactive protein) ≥2 mg/L to high-intensity'],"['rosuvastatin versus placebo', 'Conclusions', 'Rosuvastatin', 'rosuvastatin and placebo']","['Vascular Inflammation, and Incident Cardiovascular Disease', 'CVD events', 'sPLA 2 -IIA', 'risk of CVD: risk factor-adjusted hazard ratio', 'higher CVD risk', 'Baseline and 1-year plasma sPLA 2 -IIA mass', 'Baseline sPLA 2 -IIA mass']","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439268', 'cui_str': 'microgram/mL'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0947751', 'cui_str': 'Vascular inflammations'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2756983', 'cui_str': 'SPLA2 Phospholipases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.414481,"The rs11573156C variant in PLA2G2A (encoding sPLA 2 -IIA) had the strongest effect on sPLA 2 -II: median (25th-75th percentile, ng/mL) for CC and GG genotypes: 2.79 (1.97-4.01) and 7.38 (5.38-10.19), respectively; and had nonsignificant trend for higher CVD risk (hazard ratio, 1.11; 95% CI, 0.89-1.38; P=0.34).","[{'ForeName': 'Akintunde O', 'Initials': 'AO', 'LastName': 'Akinkuolie', 'Affiliation': ""From the Center for Lipid Metabolomics, Division of Preventive Medicine (A.O.A., P.R.L., R.J.G., P.M.R., D.I.C., S.M.), Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Lawler', 'Affiliation': ""From the Center for Lipid Metabolomics, Division of Preventive Medicine (A.O.A., P.R.L., R.J.G., P.M.R., D.I.C., S.M.), Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Audrey Y', 'Initials': 'AY', 'LastName': 'Chu', 'Affiliation': 'Merck Research Laboratories, Boston, MA (A.Y.C.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Caulfield', 'Affiliation': 'Department of Endocrinology & CVD, Quest Diagnostics Nichols Institute, San Juan Capistrano, CA (M.C., J.M.).'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Mu', 'Affiliation': 'Department of Endocrinology & CVD, Quest Diagnostics Nichols Institute, San Juan Capistrano, CA (M.C., J.M.).'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Medical Evidence & Observational Research, Global Medical Affairs (B.D., F.N.), AstraZeneca R&D, Mölndal, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Nyberg', 'Affiliation': 'Medical Evidence & Observational Research, Global Medical Affairs (B.D., F.N.), AstraZeneca R&D, Mölndal, Sweden.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""From the Center for Lipid Metabolomics, Division of Preventive Medicine (A.O.A., P.R.L., R.J.G., P.M.R., D.I.C., S.M.), Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""From the Center for Lipid Metabolomics, Division of Preventive Medicine (A.O.A., P.R.L., R.J.G., P.M.R., D.I.C., S.M.), Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hurt-Camejo', 'Affiliation': 'Cardiovascular & Metabolic Diseases, Innovative Medicines (E.H.-C.), AstraZeneca R&D, Mölndal, Sweden.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Chasman', 'Affiliation': ""From the Center for Lipid Metabolomics, Division of Preventive Medicine (A.O.A., P.R.L., R.J.G., P.M.R., D.I.C., S.M.), Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""From the Center for Lipid Metabolomics, Division of Preventive Medicine (A.O.A., P.R.L., R.J.G., P.M.R., D.I.C., S.M.), Department of Medicine, Brigham and Women's Hospital, Boston, MA.""}]","Arteriosclerosis, thrombosis, and vascular biology",['10.1161/ATVBAHA.118.311894']
493,30376866,"Baseline exposure, antibody subclass, and hepatitis B response differentially affect malaria protective immunity following RTS,S/AS01E vaccination in African children.","BACKGROUND
The RTS,S/AS01E vaccine provides partial protection against malaria in African children, but immune responses have only been partially characterized and do not reliably predict protective efficacy. We aimed to evaluate comprehensively the immunogenicity of the vaccine at peak response, the factors affecting it, and the antibodies associated with protection against clinical malaria in young African children participating in the multicenter phase 3 trial for licensure.
METHODS
We measured total IgM, IgG, and IgG 1-4 subclass antibodies to three constructs of the Plasmodium falciparum circumsporozoite protein (CSP) and hepatitis B surface antigen (HBsAg) that are part of the RTS,S vaccine, by quantitative suspension array technology. Plasma and serum samples were analyzed in 195 infants and children from two sites in Ghana (Kintampo) and Mozambique (Manhiça) with different transmission intensities using a case-control study design. We applied regression models and machine learning techniques to analyze immunogenicity, correlates of protection, and factors affecting them.
RESULTS
RTS,S/AS01E induced IgM and IgG, predominantly IgG1 and IgG3, but also IgG2 and IgG4, subclass responses. Age, site, previous malaria episodes, and baseline characteristics including antibodies to CSP and other antigens reflecting malaria exposure and maternal IgGs, nutritional status, and hemoglobin concentration, significantly affected vaccine immunogenicity. We identified distinct signatures of malaria protection and risk in RTS,S/AS01E but not in comparator vaccinees. IgG2 and IgG4 responses to RTS,S antigens post-vaccination, and anti-CSP and anti-P. falciparum antibody levels pre-vaccination, were associated with malaria risk over 1-year follow-up. In contrast, antibody responses to HBsAg (all isotypes, subclasses, and timepoints) and post-vaccination IgG1 and IgG3 to CSP C-terminus and NANP were associated with protection. Age and site affected the relative contribution of responses in the correlates identified.
CONCLUSIONS
Cytophilic IgG responses to the C-terminal and NANP repeat regions of CSP and anti-HBsAg antibodies induced by RTS,S/AS01E vaccination were associated with malaria protection. In contrast, higher malaria exposure at baseline and non-cytophilic IgG responses to CSP were associated with disease risk. Data provide new correlates of vaccine success and failure in African children and reveal key insights into the mode of action that can guide development of more efficacious next-generation vaccines.",2018,"We identified distinct signatures of malaria protection and risk in RTS,S/AS01E but not in comparator vaccinees.","['African children', 'young African children participating in the multicenter phase 3 trial for licensure', '195 infants and children from two sites in Ghana (Kintampo) and Mozambique (Manhiça) with different transmission intensities using a case-control study design']",[],"['Plasma and serum samples', 'Baseline exposure, antibody subclass, and hepatitis B response', 'malaria risk', 'antibodies to CSP and other antigens reflecting malaria exposure and maternal IgGs, nutritional status, and hemoglobin concentration', 'IgG2 and IgG4, subclass responses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0023637', 'cui_str': 'Licensure'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0026655', 'cui_str': 'Republic of Mozambique'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0007328', 'cui_str': 'Case-Referrent Studies'}]",[],"[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0445604', 'cui_str': 'Subclass (attribute)'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0020856', 'cui_str': 'IgG2'}, {'cui': 'C0020860', 'cui_str': 'IgG4'}]",195.0,0.0432112,"We identified distinct signatures of malaria protection and risk in RTS,S/AS01E but not in comparator vaccinees.","[{'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Ubillos', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Carrer Rosselló 153 CEK building, E-08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Aintzane', 'Initials': 'A', 'LastName': 'Ayestaran', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Carrer Rosselló 153 CEK building, E-08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Augusto J', 'Initials': 'AJ', 'LastName': 'Nhabomba', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Rua 12, Cambeve, Vila de Manhiça, CP 1929, Maputo, Mozambique.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dosoo', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Vidal', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Carrer Rosselló 153 CEK building, E-08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Alfons', 'Initials': 'A', 'LastName': 'Jiménez', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Carrer Rosselló 153 CEK building, E-08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Chenjerai', 'Initials': 'C', 'LastName': 'Jairoce', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Rua 12, Cambeve, Vila de Manhiça, CP 1929, Maputo, Mozambique.'}, {'ForeName': 'Hèctor', 'Initials': 'H', 'LastName': 'Sanz', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Carrer Rosselló 153 CEK building, E-08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Aguilar', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Carrer Rosselló 153 CEK building, E-08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Nana Aba', 'Initials': 'NA', 'LastName': 'Williams', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Carrer Rosselló 153 CEK building, E-08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Díez-Padrisa', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Carrer Rosselló 153 CEK building, E-08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Mpina', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Center, P.O. Box 74, Bagamoyo, Tanzania.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Sorgho', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Nanoro, Burkina Faso.'}, {'ForeName': 'Selidji Todagbe', 'Initials': 'ST', 'LastName': 'Agnandji', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), BP 242, Lambaréné, Gabon.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kariuki', 'Affiliation': 'Kenya Medical Research Institute (KEMRI)/Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mordmüller', 'Affiliation': 'Swiss Tropical and Public Health Institute, Socinstrasse 57, 4002, Basel, Switzerland.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Daubenberger', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Center, P.O. Box 74, Bagamoyo, Tanzania.'}, {'ForeName': 'Kwaku Poku', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Owusu-Agyei', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Jahit', 'Initials': 'J', 'LastName': 'Sacarlal', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Rua 12, Cambeve, Vila de Manhiça, CP 1929, Maputo, Mozambique.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Aide', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Rua 12, Cambeve, Vila de Manhiça, CP 1929, Maputo, Mozambique.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Aponte', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Carrer Rosselló 153 CEK building, E-08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Sheetij', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Walter Reed Army Institute of Research (WRAIR), Silver Spring, MD, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Gyan', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Campo', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Carrer Rosselló 153 CEK building, E-08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'Valim', 'Affiliation': 'Department of Osteopathic Medical Specialties, Michigan State University, 909 Fee Road, Room B 309 West Fee Hall, East Lansing, MI, 48824, USA.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Moncunill', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Carrer Rosselló 153 CEK building, E-08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Dobaño', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Carrer Rosselló 153 CEK building, E-08036, Barcelona, Catalonia, Spain. carlota.dobano@isglobal.org.'}]",BMC medicine,['10.1186/s12916-018-1186-4']
494,30420171,Fecal Akkermansia muciniphila Is Associated with Body Composition and Microbiota Diversity in Overweight and Obese Women with Breast Cancer Participating in a Presurgical Weight Loss Trial.,"BACKGROUND
Akkermansia muciniphila (AM) is a gram-negative, mucin-degrading bacteria inhabiting the gastrointestinal tract associated with host phenotypes and disease states.
OBJECTIVE
Explore characteristics of overweight and obese female early-stage (0 to II) breast cancer patients with low AM relative abundance (LAM) vs high (HAM) enrolled in a presurgical weight-loss trial.
DESIGN
Secondary analysis of pooled participants in a randomized controlled trial (NCT02224807).
PARTICIPANTS/SETTING
During the period from 2014 to 2017, 32 female patients with breast cancer were randomized to weight-loss or attention-control arms from time of diagnosis-to-lumpectomy (mean=30±9 days).
INTERVENTION
All were instructed to correct nutrient deficiencies via food sources and on upper-body exercises. The weight-loss group received additional guidance to promote 0.5 to 1 kg/wk weight-loss via energy restriction and aerobic exercise.
MAIN OUTCOME MEASURES
At baseline and follow-up, sera, fecal samples, two-24 hour dietary recalls and dual x-ray absorptiometry were obtained. Bacterial DNA was isolated from feces and polymerase chain reaction (16S) amplified. Inflammatory cytokines were measured in sera.
STATISTICAL ANALYSES PERFORMED
Differences between LAM and HAM participants were analyzed using t tests and nonparametric tests. Spearman correlations explored relationships between continuous variables.
RESULTS
Participants were aged 61±9 years with body mass index 34.8±6. Mean AM relative abundance was 0.02% (0.007% to 0.06%) and 1.59% (0.59% to 13.57%) for LAM and HAM participants, respectively. At baseline, women with HAM vs LAM had lower fat mass (38.9±11.2 kg vs 46.4±9.0 kg; P=0.044). Alpha diversity (ie, species richness) was higher in women with HAM (360.8±84.8 vs 282.4±69.6; P=0.008) at baseline, but attenuated after weight-loss (P=0.058). At baseline, interleukin-6 level was associated with species richness (ρ=-0.471, P=0.008) and fat mass (ρ=0.529, P=0.002), but not AM. Change in total dietary fiber was positively associated with AM in LAM (ρ=0.626, P=0.002), but not HAM (ρ=0.436, P=0.180) participants.
CONCLUSIONS
Among women with early-stage breast cancer, body composition is associated with AM, microbiota diversity, and interleukin-6 level. AM may mediate the effects of dietary fiber in improving microbiota composition.",2020,"Change in total dietary fiber was positively associated with AM in LAM (ρ=0.626, P=0.002), but not HAM (ρ=0.436, P=0.180) participants.
","['overweight and obese female early-stage (0 to II) breast cancer patients with low AM relative abundance (LAM) vs high (HAM) enrolled in a presurgical weight-loss trial', '32 female patients with breast cancer', 'women with early-stage breast cancer', 'Participants were aged 61±9 years with body mass index 34.8±6', 'Overweight and Obese Women with Breast Cancer Participating in a Presurgical Weight Loss Trial']",['weight-loss or attention-control arms from time of diagnosis-to-lumpectomy (mean=30±9 days'],"['interleukin-6 level', 'Mean AM relative abundance', 'fat mass', 'Alpha diversity (ie, species richness', 'total dietary fiber', 'Inflammatory cytokines', 'lower fat mass']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",32.0,0.125547,"Change in total dietary fiber was positively associated with AM in LAM (ρ=0.626, P=0.002), but not HAM (ρ=0.436, P=0.180) participants.
","[{'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Frugé', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Van der Pol', 'Affiliation': ''}, {'ForeName': 'Laura Q', 'Initials': 'LQ', 'LastName': 'Rogers', 'Affiliation': ''}, {'ForeName': 'Casey D', 'Initials': 'CD', 'LastName': 'Morrow', 'Affiliation': ''}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Tsuruta', 'Affiliation': ''}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Demark-Wahnefried', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2018.08.164']
495,30415786,Implementing statistical methods for generalizing randomized trial findings to a target population.,"Randomized trials are considered the gold standard for assessing the causal effects of a drug or intervention in a study population, and their results are often utilized in the formulation of health policy. However, there is growing concern that results from trials do not necessarily generalize well to their respective target populations, in which policies are enacted, due to substantial demographic differences between study and target populations. In trials related to substance use disorders (SUDs), especially, strict exclusion criteria make it challenging to obtain study samples that are fully ""representative"" of the populations that policymakers may wish to generalize their results to. In this paper, we provide an overview of post-trial statistical methods for assessing and improving upon the generalizability of a randomized trial to a well-defined target population. We then illustrate the different methods using a randomized trial related to methamphetamine dependence and a target population of substance abuse treatment seekers, and provide software to implement the methods in R using the ""generalize"" package. We discuss several practical considerations for researchers who wish to utilize these tools, such as the importance of acquiring population-level data to represent the target population of interest, and the challenges of data harmonization.",2019,"We then illustrate the different methods using a randomized trial related to methamphetamine dependence and a target population of substance abuse treatment seekers, and provide software to implement the methods in R using the ""generalize"" package.",[],[],[],[],[],[],,0.0726531,"We then illustrate the different methods using a randomized trial related to methamphetamine dependence and a target population of substance abuse treatment seekers, and provide software to implement the methods in R using the ""generalize"" package.","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ackerman', 'Affiliation': 'Department of Biostatistics, The Johns Hopkins Bloomberg School of Public Health, USA. Electronic address: backer10@jhu.edu.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Schmid', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Kara E', 'Initials': 'KE', 'LastName': 'Rudolph', 'Affiliation': 'Emergency Medicine, School of Medicine, University of California, Davis, USA.'}, {'ForeName': 'Marissa J', 'Initials': 'MJ', 'LastName': 'Seamans', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Susukida', 'Affiliation': 'Department of Mental Health Policy, National Center of Neurology and Psychiatry, Japan.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Mojtabai', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Stuart', 'Affiliation': 'Department of Biostatistics, The Johns Hopkins Bloomberg School of Public Health, USA; Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2018.10.033']
496,30412233,A Community Choir Intervention to Promote Well-Being Among Diverse Older Adults: Results From the Community of Voices Trial.,"OBJECTIVES
To test effects of the Community of Voices choir intervention on the health, well-being, and health care costs of racial/ethnically diverse older adults.
METHOD
Twelve Administration-on-Aging-supported senior centers were cluster randomized into two groups: the intervention group started the choir immediately and a wait-list control group began the choir 6 months later. The choir program was designed for community-dwelling adults aged 60 years and older. The multimodal intervention comprises activities that engage participants cognitively, physically, and socially. Outcome measures assessed these three domains as well as health care utilization and costs. The intention-to-treat comparison was at 6 months.
RESULTS
The sample (N = 390) had a mean age of 71.3 years (SD = 7.2); 65% were nonwhite. Six-month retention was 92%. Compared to controls, intervention group members experienced significantly greater improvements in loneliness (p = .02; standardized effect size [ES = 0.34] and interest in life (p = .008, ES = 0.39). No significant group differences were observed for cognitive or physical outcomes or for health care costs.
DISCUSSION
Findings support adoption of community choirs for reducing loneliness and increasing interest in life among diverse older adults. Further efforts need to examine the mechanisms by which engagement in choirs improves aspects of well-being and reduces health disparities among older adults, including potential longer-term effects.
CLINICALTRIALS.GOV REGISTRATION
NCT01869179 registered January 9, 2013.",2020,"Compared to controls, intervention group members experienced significantly greater improvements in loneliness (p=0.02; standardized effect size (ES=0.34) and interest in life (p=0.008, ES=0.39).","['Diverse Older Adults', 'racial/ethnically diverse older adults', 'The sample (N=390) had a mean age of 71.3 years (SD=7.2); 65% were non-white', 'Method\n\n\nTwelve Administration-on-Aging-supported senior centers', 'community-dwelling adults aged 60 and over', 'diverse older adults', 'older adults']","['Community Choir Intervention', 'Community of Voices choir intervention', 'intervention group started the choir immediately and a wait-list control group began the choir 6 months later']","['loneliness', 'cognitive or physical outcomes or for healthcare costs', 'healthcare utilization and costs']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3658240', 'cui_str': 'Centers for the Aged'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0023974', 'cui_str': 'Loneliness'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",390.0,0.0333673,"Compared to controls, intervention group members experienced significantly greater improvements in loneliness (p=0.02; standardized effect size (ES=0.34) and interest in life (p=0.008, ES=0.39).","[{'ForeName': 'Julene K', 'Initials': 'JK', 'LastName': 'Johnson', 'Affiliation': 'Institute for Health & Aging, University of California San Francisco, Bethesda, Maryland.'}, {'ForeName': 'Anita L', 'Initials': 'AL', 'LastName': 'Stewart', 'Affiliation': 'Institute for Health & Aging, University of California San Francisco, Bethesda, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Acree', 'Affiliation': 'Osher Center for Integrative Medicine, University of California San Francisco, Bethesda, Maryland.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Nápoles', 'Affiliation': 'Intramural Research Program, National Institute of Minority Health and Health Disparities, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Flatt', 'Affiliation': 'Institute for Health & Aging, University of California San Francisco, Bethesda, Maryland.'}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'Max', 'Affiliation': 'Institute for Health & Aging, University of California San Francisco, Bethesda, Maryland.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Gregorich', 'Affiliation': 'Center for Aging in Diverse Communities, University of California San Francisco, Bethesda, Maryland.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gby132']
497,32144511,Study of transcranial photobiomodulation at 945-nm wavelength: anxiety and depression.,"Transcranial photobiomodulation is an innovative method for the stimulation of neural activity which consists of the exposure of neural tissue to low-level light irradiance. In the present study, light-emitting diodes (LEDs) were used as light source due to their practicality and low cost. The objective was to analyze the effects of transcranial photobiomodulation using 945-nm LED in university students with anxiety and depression. Sample was composed of 22 individuals (17-25 years of age) divided into 2 groups of 11. LED group was treated with 945-nm LEDs for 1 min and 25 s (9.35 J/cm 2 ), while in the placebo group, the device was off when placed in contact with the frontal bone for the same amount of time as in treatment group. Participants were evaluated at baseline and after 30 days with the hospital anxiety and depression scale (HADS), the faces test, the designs test, and the grip strength test. On the HADS for anxiety, the mean PAB, PAA, PhAB, and PhAA were 13.89 ± 3.55, 12.82 ± 3.18, 10.75 ± 2.49, and 6.66 ± 2.50 points, respectively. In the HADS for depression, the mean for the PDB group was 13.89 ± 3.55 points, in the PhDB group 12.82 ± 3.18 points, in the PDA group 10.75 ± 2.49 points, and in the PhDA group 6.66 ± 2.50 points. In the PA and PD groups, mean values of 8.0 ± 1.5 and 8.9 ± 1.26 scores were obtained, but did not reach significance; however, between PA and PhD analysis, a significance level of p = 0.0003 was obtained. The 945-nm LED transcranial photobiomodulation improves brain activity and may clinically decrease anxiety and depression.",2020,The 945-nm LED transcranial photobiomodulation improves brain activity and may clinically decrease anxiety and depression.,"['university students with anxiety and depression', '22 individuals (17-25\xa0years of age) divided into 2 groups of 11']","['transcranial photobiomodulation', '945-nm LEDs', 'placebo', 'Transcranial photobiomodulation']","['brain activity', 'hospital anxiety and depression scale (HADS', 'anxiety and depression', 'HADS for anxiety, the mean PAB, PAA, PhAB, and PhAA']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0267964', 'cui_str': 'Pancreatic acinar atrophy (disorder)'}]",,0.030199,The 945-nm LED transcranial photobiomodulation improves brain activity and may clinically decrease anxiety and depression.,"[{'ForeName': 'Flávio Klinpovous', 'Initials': 'FK', 'LastName': 'Kerppers', 'Affiliation': 'Universidade Estadual do Centro-Oeste, Guarapuava, Paraná, Brazil.'}, {'ForeName': 'Kesia Maria Mangoni Gonçalves', 'Initials': 'KMMG', 'LastName': 'Dos Santos', 'Affiliation': 'Universidade Estadual do Centro-Oeste, Guarapuava, Paraná, Brazil.'}, {'ForeName': 'Maria Elvira Ribeiro', 'Initials': 'MER', 'LastName': 'Cordeiro', 'Affiliation': 'Universidade Estadual do Centro-Oeste, Guarapuava, Paraná, Brazil.'}, {'ForeName': 'Mário César', 'Initials': 'MC', 'LastName': 'da Silva Pereira', 'Affiliation': 'Laboratory of Neuroanatomy and Neurophysiology, Universidade Estadual do Centro-Oeste, Guarapuava, Paraná, Brazil.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Barbosa', 'Affiliation': 'Laboratory of Neuroanatomy and Neurophysiology, Universidade Estadual do Centro-Oeste, Guarapuava, Paraná, Brazil.'}, {'ForeName': 'André Alexandre', 'Initials': 'AA', 'LastName': 'Pezzini', 'Affiliation': 'Universidade Estadual do Oeste do Paraná, Cascavel, PR, Brazil.'}, {'ForeName': 'Luiza Ferreira', 'Initials': 'LF', 'LastName': 'Cunha', 'Affiliation': 'Universidade Estadual do Centro-Oeste, Guarapuava, Paraná, Brazil.'}, {'ForeName': 'Maiara', 'Initials': 'M', 'LastName': 'Fonseca', 'Affiliation': 'Universidade Estadual do Centro-Oeste, Guarapuava, Paraná, Brazil.'}, {'ForeName': 'Ketlin', 'Initials': 'K', 'LastName': 'Bragnholo', 'Affiliation': 'Universidade Estadual do Centro-Oeste, Guarapuava, Paraná, Brazil.'}, {'ForeName': 'Afonso Shiguemi Inoue', 'Initials': 'ASI', 'LastName': 'Salgado', 'Affiliation': 'Integrative Health School, Londrina, Paraná, Brazil.'}, {'ForeName': 'Ivo Ilvan', 'Initials': 'II', 'LastName': 'Kerppers', 'Affiliation': 'Laboratory of Neuroanatomy and Neurophysiology, Universidade Estadual do Centro-Oeste, Guarapuava, Paraná, Brazil. ikerppers@gmail.com.'}]",Lasers in medical science,['10.1007/s10103-020-02983-7']
498,30283029,"Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD).","Numerous placebo-controlled studies have demonstrated the ability of ketamine, an NMDA receptor antagonist, to induce rapid (within hours), transient antidepressant effects when administered intravenously (IV) at subanesthetic doses (0.5 mg/kg over 40 min). However, the optimal antidepressant dose remains unknown. We aimed to compare to active placebo the rapid acting antidepressant properties of a broad range of subanesthetic doses of IV ketamine among outpatients with treatment-resistant depression (TRD). A range of IV ketamine doses were compared to active placebo in the treatment of adult TRD over a 3-day period following a single infusion over 40 min. This was an outpatient study conducted across six US academic sites. Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode. Following a washout period, 99 eligible subjects were randomly assigned to one of the five arms in a 1:1:1:1:1 fashion: a single intravenous dose of ketamine 0.1 mg/kg (n = 18), a single dose of ketamine 0.2 mg/kg (n = 20), a single dose of ketamine 0.5 mg/kg (n = 22), a single dose of ketamine 1.0 mg/kg (n = 20), and a single dose of midazolam 0.045 mg/kg (active placebo) (n = 19). The study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I) were performed at days 0, 1, 3 (endpoint), 5, 7, 14, and 30 to assess the safety and efficacy. The overall group × time interaction effect was significant for the primary outcome measure, the HAM-D-6. In post hoc pairwise comparisons controlling for multiple comparisons, standard dose (0.5 mg/kg) and high dose (1 mg/kg) of intravenous ketamine were superior to active placebo; a low dose (0.1 mg/kg) was significant only prior to adjustment (p = 0.02, p-adj = 0.14, d = -0.82 at day 1). Most of the interaction effect was due to differences at day 1, with no significant adjusted pairwise differences at day 3. This pattern generally held for secondary outcomes. The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses. Our results suggest that there is evidence for the efficacy of the 0.5 mg/kg and 1.0 mg/kg subanesthetic doses of IV ketamine and no clear or consistent evidence for clinically meaningful efficacy of lower doses of IV ketamine. Trial Registration: NCT01920555.",2020,"The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.","['99 eligible subjects', 'Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode', 'treatment-resistant depression (TRD', 'outpatients with treatment-resistant depression (TRD']","['ketamine', 'IV ketamine', 'placebo', 'midazolam 0.045\u2009mg/kg (active placebo', 'ketamine 0.1\u2009mg/kg']","['safety and efficacy', 'HAM-D-6', 'dissociative symptoms and transient blood pressure elevations', 'study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4517410', 'cui_str': 'Zero point zero four five'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",99.0,0.456136,"The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.","[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA. mfava@mgh.harvard.edu.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Judge', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Bettina B', 'Initials': 'BB', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Lee C', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Debattista', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Schatzberg', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Wilkinson', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0256-5']
499,32128877,Efficacy of low-dose versus high-dose simethicone with polyethylene glycol for bowel preparation: A prospective randomized controlled trial.,"BACKGROUND AND AIM
Additional simethicone (SIM) can improve adequate bowel preparation and adenoma detection rate (ADR). However, there is no consensus on the optimal dose of SIM. In this study, we compared the adequate bowel preparation rate with supplementation of split-dose 2 L polyethylene glycol (PEG) with low-dose SIM (200 mg) versus high-dose SIM (1200 mg).
METHODS
This was a prospective, randomized, observer-blinded trial involving consecutive subjects undergoing colonoscopy. The primary outcome was adequate bowel preparation as assessed by Boston Bowel Preparation Scale (BBPS) score.
RESULTS
Four hundred subjects were randomly allocated to low-dose SIM or high-dose SIM group. Baseline characteristics were comparable in the two groups (P > 0.05). No significant between-group differences were observed with respect to total bubble scale (BS) (8.49 ± 1.00 vs 8.39 ± 1.10, P = 0.07), total BBPS score (8.70 ± 0.81 vs 8.29 ± 1.18, P = 0.98), ADR (33.68% vs 31.79%, P = 0.69) or withdrawal time (13 [range, 10-16] min vs 13 [10-15] min, P = 0.96). The intubation time in low-dose SIM group was significantly shorter than that in high-dose SIM group (8 (4-16) min vs 10 [6-17] min, P = 0.04). In addition, BS scores as well as diminutive ADR in right colon were superior in the low-dose SIM group (2.68 ± 0.59 vs 2.52 ± 0.73, P = 0.03 and 54.29% vs 30.30%, P = 0.046, respectively).
CONCLUSION
Addition of low-dose SIM to split-dose 2 L PEG was as effective as addition of high-dose SIM with respect to adequate bowel preparation, ADR and patient tolerance. However, low-dose SIM was superior with respect to intubation time, right colon BS scores, right colon diminutive ADR and cost savings.",2020,"However, low-dose SIM was superior with respect to intubation time, right colon BS scores, right colon diminutive ADR and cost savings.","['Four hundred subjects', 'consecutive subjects undergoing colonoscopy']","['split-dose 2L polyethylene glycol (PEG) with low-dose SIM (200 mg) versus high-dose SIM', 'simethicone (SIM', 'Low- vs. High-Dose Simethicone with Polyethylene Glycol']","['adequate bowel preparation and adenoma detection rate (ADR', 'intubation time, right colon BS scores, right colon diminutive ADR and cost savings', 'total BBPS score', 'diminutive ADR in right colon', 'ADR', 'adequate bowel preparation as assessed by Boston Bowel Preparation Scale (BBPS) score', 'BS scores', 'withdrawal time', 'intubation time', 'total bubble scale (BS']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0037138', 'cui_str': 'Simethicone'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}, {'cui': 'C0222045'}]",400.0,0.211159,"However, low-dose SIM was superior with respect to intubation time, right colon BS scores, right colon diminutive ADR and cost savings.","[{'ForeName': 'De-Feng', 'Initials': 'DF', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Ming-Han', 'Initials': 'MH', 'LastName': 'Luo', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Qing-Qing', 'Initials': 'QQ', 'LastName': 'Du', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Hai-Yang', 'Initials': 'HY', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Yan-Hui', 'Initials': 'YH', 'LastName': 'Tian', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Rui-Yue', 'Initials': 'RY', 'LastName': 'Shi', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xiong', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Ming-Guang', 'Initials': 'MG', 'LastName': 'Lai', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Ying-Xue', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Ben-Hua', 'Initials': 'BH', 'LastName': 'Wu', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Zheng-Lei', 'Initials': 'ZL', 'LastName': 'Xu', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Ding-Guo', 'Initials': 'DG', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Li-Sheng', 'Initials': 'LS', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15022']
500,30534990,Engaging hospitalized patients with personalized health information: a randomized trial of an inpatient portal.,"Objective
To determine the effects of an inpatient portal intervention on patient activation, patient satisfaction, patient engagement with health information, and 30-day hospital readmissions.
Methods and Materials
From March 2014 to May 2017, we enrolled 426 English- or Spanish-speaking patients from 2 cardiac medical-surgical units at an urban academic medical center. Patients were randomized to 1 of 3 groups: 1) usual care, 2) tablet with general Internet access (tablet-only), and 3) tablet with an inpatient portal. The primary study outcome was patient activation (Patient Activation Measure-13). Secondary outcomes included all-cause readmission within 30 days, patient satisfaction, and patient engagement with health information.
Results
There was no evidence of a difference in patient activation among patients assigned to the inpatient portal intervention compared to usual care or the tablet-only group. Patients in the inpatient portal group had lower 30-day hospital readmissions (5.5% vs. 12.9% tablet-only and 13.5% usual care; P = 0.044). There was evidence of a difference in patient engagement with health information between the inpatient portal and tablet-only group, including looking up health information online (89.6% vs. 51.8%; P < 0.001). Healthcare providers reported that patients found the portal useful and that the portal did not negatively impact healthcare delivery.
Conclusions
Access to an inpatient portal did not significantly improve patient activation, but it was associated with looking up health information online and with a lower 30-day hospital readmission rate. These results illustrate benefit of providing hospitalized patients with real-time access to their electronic health record data while in the hospital.
Trial Registration
ClinicalTrials.gov Identifier: NCT01970852.",2019,There was no evidence of a difference in patient activation among patients assigned to the inpatient portal intervention compared to usual care or the tablet-only group.,"['From March 2014 to May 2017, we enrolled 426 English- or Spanish-speaking patients from 2 cardiac medical-surgical units at an urban academic medical center', 'Engaging hospitalized patients with personalized health information']","['inpatient portal intervention', 'usual care, 2) tablet with general Internet access (tablet-only), and 3) tablet with an inpatient portal']","['cause readmission within 30 days, patient satisfaction, and patient engagement with health information', 'patient activation (Patient Activation Measure-13', '30-day hospital readmission rate', '30-day hospital readmissions', 'patient engagement with health information', 'patient activation, patient satisfaction, patient engagement with health information, and 30-day hospital readmissions', 'patient activation']","[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C3508152', 'cui_str': 'Patient Engagement'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C4075707', 'cui_str': 'PAM - Patient Activation Measure'}, {'cui': 'C0587438', 'cui_str': 'Day hospital (environment)'}]",426.0,0.0821798,There was no evidence of a difference in patient activation among patients assigned to the inpatient portal intervention compared to usual care or the tablet-only group.,"[{'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Masterson Creber', 'Affiliation': 'Department of Healthcare Policy & Research, Division of Health Informatics, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Lisa V', 'Initials': 'LV', 'LastName': 'Grossman', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Ryan', 'Affiliation': 'The Value Institute at NewYork-Presbyterian Hospital, New York, New York, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Qian', 'Affiliation': 'Department of Biostatistics, Columbia University, New York, New York, USA.'}, {'ForeName': 'Fernanda C G', 'Initials': 'FCG', 'LastName': 'Polubriaginof', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Restaino', 'Affiliation': 'Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Bakken', 'Affiliation': 'Department of Biomedical Informatics, School of Nursing, Data Science Institute, Columbia University, New York, New York, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hripcsak', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Vawdrey', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocy146']
501,31740727,Comparison of pressure- and volume-controlled ventilation during laparoscopic colectomy in patients with colorectal cancer.,"This study investigated the differences in airway mechanics and postoperative respiratory complications using two mechanical ventilation modalities and the relationship between biomarkers and postoperative respiratory complications in patients with colorectal cancer who underwent laparoscopic colectomy. Forty-six patients with colorectal cancer scheduled for laparoscopic colectomy were randomly allocated to receive mechanical ventilation using either volume-controlled ventilation (VCV) (n = 23) or pressure-controlled ventilation (PCV) (n = 23). Respiratory parameters were measured and plasma sRAGE and S100A12 were collected 20 minutes after the induction of anesthesia in the supine position without pneumoperitoneum (T1), 40 minutes after 30° Trendelenburg position with pneumoperitoneum (T2), at skin closure in the supine position (T3), and 24 hours after the operation (T4). The peak airway pressure (Ppeak) at T2 was lower in the PCV group than in the VCV group. The plateau airway pressures (Pplat) at T2 and T3 were higher in the VCV group than in the PCV group. Plasma levels of sRAGE at T2 and T3 were 1.6- and 1.4-fold higher in the VCV group than in the PCV group, while plasma S100A12 levels were 2.6- and 2.2-fold higher in the VCV group than in the PCV group, respectively. There were significant correlations between Ppeak and sRAGE, and between Ppeak and S100A12. There were also correlations between Pplat and sRAGE, and between Pplat and S100A12. sRAGE and S100A12 levels at T2 and T3 showed high sensitivity and specificity for postoperative respiratory complications. Postoperative respiratory complications were 3-fold higher in the VCV group than in the PCV group. In conclusion, during laparoscopic colectomy in patients with colorectal cancer, the peak airway pressure, the incidence of postoperative respiratory complications, and plasma sRAGE and S100A12 levels were lower in the PCV group than in the VCV group. Intra- and postoperative plasma sRAGE and S100A12 were useful for predicting the development of postoperative respiratory complications.",2019,sRAGE and S100A12 levels at T2 and T3 showed high sensitivity and specificity for postoperative respiratory complications.,"['Forty-six patients with colorectal cancer scheduled for laparoscopic colectomy', 'patients with colorectal cancer', 'patients with colorectal cancer who underwent laparoscopic colectomy']","['pressure- and volume-controlled ventilation', 'mechanical ventilation using either volume-controlled ventilation (VCV) (n\u2009=\u200923) or pressure-controlled ventilation (PCV', 'laparoscopic colectomy', 'VCV', 'mechanical ventilation modalities']","['Plasma levels of sRAGE', 'sRAGE and S100A12 levels', 'plasma S100A12 levels', 'peak airway pressure (Ppeak', 'Postoperative respiratory complications', 'plateau airway pressures (Pplat', 'peak airway pressure, the incidence of postoperative respiratory complications, and plasma sRAGE and S100A12 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation (procedure)'}, {'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4019423', 'cui_str': 'ENRAGE Protein'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",46.0,0.0391975,sRAGE and S100A12 levels at T2 and T3 showed high sensitivity and specificity for postoperative respiratory complications.,"[{'ForeName': 'Sangbong', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Division of Respirology, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Geun Joo', 'Initials': 'GJ', 'LastName': 'Choi', 'Affiliation': 'Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Beom Gyu', 'Initials': 'BG', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, Seoul, Korea. roman00@naver.com.'}]",Scientific reports,['10.1038/s41598-019-53503-9']
502,30267385,Assessment of Opicinumab in Acute Optic Neuritis Using Multifocal Visual Evoked Potential.,"BACKGROUND
Multifocal visual evoked potential (MF-VEP) assesses a wider visual field than full-field VEP (FF-VEP) and potentially offers a more precise analysis of optic nerve injury and repair following optic neuritis. MF-VEP may offer advantages over FF-VEP as an endpoint in clinical trials of remyelinating therapies.
OBJECTIVE
MF-VEP testing was used to study changes in visual pathways in 48% of RENEW [phase II, opicinumab (anti-LINGO-1; BIIB033) vs. placebo after first acute unilateral optic neuritis] participants.
METHODS
This exploratory MF-VEP RENEW substudy compared mean outcomes at weeks 24 and 32 among participants in the intent-to-treat (ITT; n = 39; 72% female; mean age: 32.3 years) and per-protocol (PP; n = 31; 71% female; mean age: 32.2 years) populations in affected and fellow eye latency from fellow eye baseline latency and affected and fellow eye amplitude from their own baselines. Treatment differences were evaluated using analysis of covariance (week 24) and a mixed-effect model of repeated measures (week 32). Last observation carried forward was used to impute missing data at week 24.
RESULTS
A trend for improvement in affected eye MF-VEP latency with opicinumab versus placebo was seen in the ITT and PP populations at weeks 24 and 32. Both treatment groups in the ITT population experienced partial recovery of amplitude in the affected eye at week 32. Notably, the mean change in fellow eye amplitude at weeks 24 and 32 was - 17.57 and - 31.41 nanovolts (nV) in placebo but only - 0.59 and 1.93 nV in the opicinumab group [differences at weeks 24 and 32: 16.98 nV (p = 0.050) and 33.33 nV (p < 0.01), respectively].
CONCLUSION
Results from this substudy showed advantages of MF-VEP over FF-VEP in multicenter studies of central nervous system reparative therapies and provide novel evidence that fellow eye visual pathway amplitude loss occurs after optic neuritis but can potentially be prevented by opicinumab treatment.
REGISTRATION
ClinicalTrials.gov identifier NCT01721161.",2018,A trend for improvement in affected eye MF-VEP latency with opicinumab versus placebo was seen in the ITT and PP populations at weeks 24 and 32.,"['mean outcomes at weeks 24 and 32 among participants in the intent-to-treat (ITT; n\u2009=\u200939; 72% female; mean age', 'acute unilateral optic neuritis] participants', '32.3\xa0years) and per-protocol (PP; n\u2009=\u200931; 71% female; mean age: 32.2\xa0years) populations in affected and fellow eye latency from fellow eye baseline\xa0latency and affected and fellow eye amplitude\xa0from their own baselines']","['placebo', 'Opicinumab']","['eye MF-VEP latency', 'partial recovery of amplitude', 'mean change in fellow eye amplitude']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0029134', 'cui_str': 'Optic Neuritis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4550038', 'cui_str': 'opicinumab'}]","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.131963,A trend for improvement in affected eye MF-VEP latency with opicinumab versus placebo was seen in the ITT and PP populations at weeks 24 and 32.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Klistorner', 'Affiliation': 'Department of Ophthalmology, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Leocani', 'Affiliation': 'Neurological Department and Experimental Neurophysiology Unit, Institute of Experimental Neurology (INSPE), University Hospital-IRCCS San Raffaele, Milan, Italy.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Albrecht', 'Affiliation': 'Department of Neurology, Medical Faculty, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Aktas', 'Affiliation': 'Department of Neurology, Medical Faculty, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Butzkueven', 'Affiliation': 'Department of Neuroscience, Central Clinical School, Monash University Alfred Campus, Melbourne, VIC, Australia.'}, {'ForeName': 'Tjalf', 'Initials': 'T', 'LastName': 'Ziemssen', 'Affiliation': 'MS Center Dresden, Center of Clinical Neuroscience, University Hospital Carl Gustav Carus, Dresden University of Technology, Dresden, Germany.'}, {'ForeName': 'Focke', 'Initials': 'F', 'LastName': 'Ziemssen', 'Affiliation': 'Center for Ophthalmology, Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Jette', 'Initials': 'J', 'LastName': 'Frederiksen', 'Affiliation': 'Department of Neurology, Rigshospitalet Glostrup and University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Cadavid', 'Affiliation': 'Biogen, Cambridge, MA, USA. cadavid.diego@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",CNS drugs,['10.1007/s40263-018-0575-8']
503,32122284,Racial exclusion causes acute cortisol release among emerging-adult African Americans: The role of reduced perceived control.,"Racial discrimination contributes to stress-related health disparities among African Americans, but less is known about the acute effects of racial exclusion on the hypo-pituitary-adrenocortical response and psychological mediators. Participants were 276 Black/African American emerging-adults (54% female; M age = 21.74, SD = 2.21) who were randomly assigned to be excluded or included by White peers via the game Cyberball. Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885, p < .0001), lower perceived control ( F (1, 276) = 205.523, p < .0001), and greater cortisol release ( F (1, 274) = 4.575, p = .033). Racial exclusion's impact on cortisol release was mediated by lower perceived control (95% CI: .027, .112), but not negative affect (-.041, .013). These findings suggest that racial exclusion contributes to acute cortisol release, and that reduced perceived control is a consequence of racial discrimination that has important implications for the health of those who experience discrimination.",2020,"Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885, ","['African Americans', 'adult African Americans', 'Participants were 276 Black/African American emerging-adults (54% female; M age \xa0=\xa021.74, SD \xa0=\xa02.21) who were randomly assigned to be excluded or included by White peers via the game Cyberball']",[],"['greater cortisol release', 'cortisol release']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517630', 'cui_str': '2.21'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]",[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]",276.0,0.0475374,"Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885, ","[{'ForeName': 'Laurel M', 'Initials': 'LM', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychology, Bryn Mawr College.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Stock', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Monroe', 'Affiliation': 'Department of Psychology, Bryn Mawr College.'}, {'ForeName': 'Brianne K', 'Initials': 'BK', 'LastName': 'Molloy-Paolillo', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}, {'ForeName': 'Sharon F', 'Initials': 'SF', 'LastName': 'Lambert', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}]",The Journal of social psychology,['10.1080/00224545.2020.1729685']
504,31811950,Genetic Variant Associated With Survival of Patients With Stage II-III Colon Cancer.,"BACKGROUND & AIMS
Many genetic variants have been associated with colorectal cancer risk, although few have been associated with survival times of patients. Identification of genetic variants associated with survival times might improve our understanding of disease progression and aid in outcome prediction. We performed a genome-wide association study to identify variants associated with colon cancer survival time.
METHODS
We performed a post hoc analysis of data from NCCTG N0147 (Alliance), a randomized phase 3 trial of patients with resected stage III colon cancer, and from NSABP C-08 (NRG), a phase 3 trial that compared therapy regimens for patients with resected stage II or III colon cancer. Genotype analyses were performed on DNA from blood samples from 4974 patients. We used Cox proportional hazards regression to evaluate the association of each single nucleotide polymorphism with times of overall survival and disease-free survival, adjusting for age at diagnosis, sex, treatment group, and principal components of genetic ancestry. We performed the analysis for studies N0147 and C-08 separately, and results were combined in a fixed-effects meta-analysis.
RESULTS
A locus on chromosome 7p15.2 was significantly associated with overall survival time (P ≤ 5x10 -08 ). The most significant variant at this locus, rs76766811 (P = 1.6x10 -08 ), is common among African Americans (minor allele frequency, approximately 18%) but rare in European Americans (minor allele frequency <0.1%). Within strata of self-reported ancestry, this variant was associated with times of overall survival and disease-free survival in only African Americans (hazard ratio for overall survival, 2.82; 95% CI, 1.88-4.23; P = 5.0x10 -07 and hazard ratio for disease-free survival, 2.27; 95% CI, 1.62-3.18; P = 1.8x10 -06 ).
CONCLUSIONS
In an analysis of data from 2 trials of patients with stage II or III colon cancer, we identified rs76766811 as a potential prognostic variant in African American patients. This finding should be confirmed in additional study populations. ClinicalTrials.gov Identifiers: NCT00096278 (NSABP C-08) and NCT00079274 (NCCTG N0147).",2020,A locus on chromosome 7p15.2 was significantly associated with overall survival time (P≤5x10 -08 ).,"['African American patients', '4974 patients', 'patients with resected stage III colon cancer, and from NSABP C-08 (NRG), a phase 3 trial that compared therapy regimens for patients with resected stage II or III colon cancer', 'patients with stage II or III colon cancer', 'Patients with Stage II-III Colon Cancer']",[],"['overall survival time', 'overall survival and disease-free survival', 'colon cancer survival time']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]",4974.0,0.294248,A locus on chromosome 7p15.2 was significantly associated with overall survival time (P≤5x10 -08 ).,"[{'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Penney', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Banbury', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Bien', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Tabitha A', 'Initials': 'TA', 'LastName': 'Harrison', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Xinwei', 'Initials': 'X', 'LastName': 'Hua', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington, Seattle, Washington.'}, {'ForeName': 'Amanda I', 'Initials': 'AI', 'LastName': 'Phipps', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington, Seattle, Washington.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Amit D', 'Initials': 'AD', 'LastName': 'Joshi', 'Affiliation': 'Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Alberts', 'Affiliation': 'Department of Health Science Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Carmen J', 'Initials': 'CJ', 'LastName': 'Allegra', 'Affiliation': 'University of Florida, Gainesville, Florida; NRG Oncology, Pittsburgh, Pennsylvania.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Atkins', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, North Carolina.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Colangelo', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'George', 'Affiliation': 'University of Florida, Gainesville, Florida; NRG Oncology, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; West Virginia University Cancer Institute, Morgantown, West Virginia.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Lucas', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Suresh G', 'Initials': 'SG', 'LastName': 'Nair', 'Affiliation': 'Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Department of Health Science Research, Mayo Clinic, Rochester, Minnesota; Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Department of Health Science Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; Allegheny Health Network Cancer Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Yothers', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Peters', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington, Seattle, Washington.'}, {'ForeName': 'Polly A', 'Initials': 'PA', 'LastName': 'Newcomb', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington, Seattle, Washington.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts. Electronic address: achan@mgh.harvard.edu.""}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.11.046']
505,29982627,Clinical decision support directed to primary care patients and providers reduces cardiovascular risk: a randomized trial.,"Objective
To test the hypothesis that use of a clinical decision support (CDS) system in a primary care setting can reduce cardiovascular (CV) risk in patients.
Materials and Methods
Twenty primary care clinics were randomly assigned to usual care (UC) or CDS. For CDS clinic patients identified algorithmically with high CV risk, rooming staff were prompted by the electronic health record (EHR) to print CDS that identified evidence-based treatment options for lipid, blood pressure, weight, tobacco, or aspirin management and prioritized them based on potential benefit to the patient. The intention-to-treat analysis included 7914 adults who met high CV risk criteria at an index clinic visit and had at least one post-index visit, accounted for clustering, and assessed impact on predicted annual rate of change in 10-year CV risk over a 14-month period.
Results
The CDS was printed at 75% of targeted visits, and providers reported 85% to 98% satisfaction with various aspects of the intervention. Predicted annual rate of change in absolute 10-year CV risk was significantly better in CDS clinics than in UC clinics (-0.59% vs. +1.66%, -2.24%; P < .001), with difference in 10-year CV risk at 12 months post-index favoring the CDS group (UC 24.4%, CDS 22.5%, P < .03).
Discussion
Deploying to both patients and providers within primary care visit workflow and limiting CDS display and print burden to two mouse clicks by rooming staff contributed to high CDS use rates and high provider satisfaction.
Conclusion
This EHR-integrated, web-based outpatient CDS system significantly improved 10-year CV risk trajectory in targeted adults.",2018,"Predicted annual rate of change in absolute 10-year CV risk was significantly better in CDS clinics than in UC clinics (-0.59% vs. +1.66%, -2.24%; P < .001), with difference in 10-year CV risk at 12 months post-index favoring the CDS group (UC 24.4%, CDS 22.5%, P < .03).
","['Twenty primary care clinics', '7914 adults who met high CV risk criteria at an index clinic visit and had at least one post-index visit, accounted for clustering, and assessed impact on predicted annual rate of change in 10-year CV risk over a 14-month period', 'patients']","['usual care (UC) or CDS', 'clinical decision support (CDS) system']","['cardiovascular (CV) risk', '10-year CV risk trajectory', 'absolute 10-year CV risk', '10-year CV risk', 'cardiovascular risk']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0525070', 'cui_str': 'Decision Support Systems, Clinical'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",7914.0,0.083734,"Predicted annual rate of change in absolute 10-year CV risk was significantly better in CDS clinics than in UC clinics (-0.59% vs. +1.66%, -2.24%; P < .001), with difference in 10-year CV risk at 12 months post-index favoring the CDS group (UC 24.4%, CDS 22.5%, P < .03).
","[{'ForeName': 'JoAnn M', 'Initials': 'JM', 'LastName': 'Sperl-Hillen', 'Affiliation': 'HealthPartners Center for Chronic Care Innovation, Minneapolis, Minnesota, USA.'}, {'ForeName': 'A Lauren', 'Initials': 'AL', 'LastName': 'Crain', 'Affiliation': 'HealthPartners Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Margolis', 'Affiliation': 'HealthPartners Center for Chronic Care Innovation, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Ekstrom', 'Affiliation': 'HealthPartners Center for Chronic Care Innovation, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Appana', 'Affiliation': 'HealthPartners Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Amundson', 'Affiliation': 'HealthPartners Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'HealthPartners Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Jay R', 'Initials': 'JR', 'LastName': 'Desai', 'Affiliation': 'HealthPartners Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'HealthPartners Center for Chronic Care Innovation, Minneapolis, Minnesota, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocy085']
506,31953727,"Comparison of adenoma detection by colonoscopy between polypectomy performed during both insertion and withdrawal versus during withdrawal only: a multicenter, randomized, controlled trial.","BACKGROUND AND AIM
In standard colonoscopy, the colonoscope is inserted into the cecum, and inspection of the colonic mucosa and polypectomy are performed during withdrawal. The colon configuration can differ between the insertion and withdrawal phases, and some polyps found in the insertion phase can be missed during withdrawal. A few single-center studies investigated whether detection of polyps during the insertion phase affects the adenoma detection rate (ADR). However, the effectiveness of this strategy is unknown because of conflicting results. We aimed to determine whether polypectomy together with careful inspection during insertion increases the ADR compared with standard colonoscopy.
METHODS
A randomized, controlled, multicenter trial was conducted at three university hospitals. Patients aged 50 to 80 years were randomly assigned to the study group or control group. For patients in the study group, polypectomy was performed together with careful inspection during both colonoscope insertion and withdrawal. In the control group, polyps were inspected and removed only during colonoscope withdrawal. The primary endpoint was the ADR, which was defined as the percentage of patients with ≥ 1 adenoma.
RESULTS
A total of 1142 patients were enrolled (study group, n = 571; control group, n = 571). The ADR was similar in the 2 groups (study group, 44.1%; control group, 43.1%; P = 0.72). In the control group, 12 polyps that had been detected during colonoscope insertion were not found during withdrawal (polyp miss rate: 2.1%, 12/571).
CONCLUSION
Polypectomy and careful inspection during both colonoscope insertion and withdrawal did not improve the overall ADR compared with standard colonoscopy (NCT01925833).",2020,"CONCLUSION
Polypectomy and careful inspection during both colonoscope insertion and withdrawal did not improve the overall ADR compared with standard colonoscopy (NCT01925833).","['three university hospitals', 'Patients aged 50 to 80\xa0years', '1142 patients were enrolled (study group, n\u2009=\u2009571; control group, n\u2009=\u2009571']",[],"['ADR', 'overall ADR', 'adenoma detection rate (ADR']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}]",1142.0,0.174127,"CONCLUSION
Polypectomy and careful inspection during both colonoscope insertion and withdrawal did not improve the overall ADR compared with standard colonoscopy (NCT01925833).","[{'ForeName': 'Tae-Geun', 'Initials': 'TG', 'LastName': 'Gweon', 'Affiliation': ""Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Seung-Woo', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': ""Department of Internal Medicine, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jeong-Seon', 'Initials': 'JS', 'LastName': 'Ji', 'Affiliation': ""Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. jjsdr@catholic.ac.kr.""}, {'ForeName': 'Jeong Rok', 'Initials': 'JR', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Konkuk University Chungju Hospital, Chungju, Korea.'}, {'ForeName': 'Joon Sung', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': ""Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Byung-Wook', 'Initials': 'BW', 'LastName': 'Kim', 'Affiliation': ""Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Hwang', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': ""Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}]",Surgical endoscopy,['10.1007/s00464-019-07342-4']
507,31955321,Oxytocin effects on the resting-state mentalizing brain network.,"Oxytocin (OT) has modulatory effects in both human behavior and in the brain, which is not limited in the specific brain area but also with the potential effect on connectivity with other brain regions. Evidence indicates that OT effects on human behavior are multifaceted, such as trust behavior, decrease anxiety, empathy and bonding behavior. For the vital role of mentalizing in understanding others, here we examine whether OT has a general effect on mentalizing brain network which is associated to the effect of related social behavioral and personality traits. Using a randomized, double-blind placebo-controlled group design, we investigate the resting-state functional magnetic resonance imaging after intranasal OT or placebo. The functional connectivity (FC) maps with seed in left/right temporoparietal junction (lTPJ/rTPJ) showed that OT significantly increased connectivity between rTPJ and default attention network (DAN), but decreased the FC between lTPJ and medial prefrontal network (MPN). With machine learning approach, we report that identified altered FCs of TPJ can classify OT and placebo (PL) group. Moreover, individual's empathy trait can modulate the FC between left TPJ and right rectus (RECT), which shows a positive correlation with empathic concern in PL group but a negative correlation in OT group. These results demonstrate that OT has significant effect on FC with lTPJ and rTPJ, brain regions where are critical for mentalizing, and the empathy concern can modulate the FC. These findings advance our understanding of the neural mechanisms by which OT modulates social behaviors, especially in social interaction involving mentalizing.",2020,"The functional connectivity (FC) maps with seed in left/right temporoparietal junction (lTPJ/rTPJ) showed that OT significantly increased connectivity between rTPJ and default attention network (DAN), but decreased the FC between lTPJ and medial prefrontal network (MPN).",[],"['placebo', 'Oxytocin', 'Oxytocin (OT', 'OT']","['FC between lTPJ and medial prefrontal network (MPN', 'connectivity between rTPJ and default attention network (DAN', 'anxiety, empathy and bonding behavior', 'resting-state mentalizing brain network']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]",,0.0999403,"The functional connectivity (FC) maps with seed in left/right temporoparietal junction (lTPJ/rTPJ) showed that OT significantly increased connectivity between rTPJ and default attention network (DAN), but decreased the FC between lTPJ and medial prefrontal network (MPN).","[{'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology, Beijing, China.'}, {'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Xiaping', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology, Beijing, China.'}, {'ForeName': 'Quanying', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Biomedical Engineering, Southern University of Science and Technology, Shenzhen, China. liuqy@sustech.edu.cn.'}]",Brain imaging and behavior,['10.1007/s11682-019-00205-5']
508,31558040,Effects of mobile health on HIV risk reduction for men who have sex with men.,"Mobile health (M-Health) has become a novel method for HIV prevention and the effects need to be promoted. The study purpose was to exam how a smartphone application (app) reduces HIV risky behaviour in men who have sex with men (MSM). The Safe Behaviour and Screening (SBS) app was developed, and included five features: record, output, and resources connection; information provision; testing services; interaction; and online statistics. A random assignment was used. The experimental group used the SBS app for six months. The control group did not use any intervention. There were 130 participants in the experimental group, and 135 in the control group. The average age of all subjects was 27.38 (SD = 5.56). Compared to the control group, the experimental group had significantly higher mean score of safe behaviour knowledge, motivation, and skills; percentage of condom use during anal intercourse; frequency of searching for testing resources and getting HIV and syphilis tests. The frequency of anal intercourse and recreational drug usage were significantly lower in the experimental group. The SBS app could decrease the HIV risky behaviour among MSM and be applied to HIV prevention and nursing intervention.",2020,"Compared to the control group, the experimental group had significantly higher mean score of safe behaviour knowledge, motivation, and skills; percentage of condom use during anal intercourse; frequency of searching for testing resources and getting HIV and syphilis tests.","['130 participants in the experimental group, and 135 in the control group', 'men who have sex with men (MSM', 'men who have sex with men']","['mobile health', 'smartphone application (app', 'Mobile health (M-Health']","['frequency of anal intercourse and recreational drug usage', 'HIV risky behaviour', 'mean score of safe behaviour knowledge, motivation, and skills; percentage of condom use during anal intercourse; frequency of searching for testing resources and getting HIV and syphilis tests', 'HIV risk reduction']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0242508', 'cui_str': 'Recreational Drugs'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0919842', 'cui_str': 'Syphilis Serodiagnosis'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",130.0,0.0204205,"Compared to the control group, the experimental group had significantly higher mean score of safe behaviour knowledge, motivation, and skills; percentage of condom use during anal intercourse; frequency of searching for testing resources and getting HIV and syphilis tests.","[{'ForeName': 'Piao-Yi', 'Initials': 'PY', 'LastName': 'Chiou', 'Affiliation': 'Department of Nursing, Medical College, National Taiwan University, Taipei City, Taiwan (R.O.C).'}, {'ForeName': 'Pei-Hung', 'Initials': 'PH', 'LastName': 'Liao', 'Affiliation': 'Department of Nursing, National Taipei University of Nursing and Health Sciences, Taipei City, Taiwan (R.O.C.).'}, {'ForeName': 'Chieh-Yu', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': 'Department of Speech language pathology and audiology, National Taipei University of Nursing and Health Sciences, Taipei City, Taiwan (R.O.C.).'}, {'ForeName': 'Yu-Tz', 'Initials': 'YT', 'LastName': 'Hsu', 'Affiliation': 'Department of Infection, Mackay Memorial Hospital, Taipei City, Taiwan (R.O.C.).'}]",AIDS care,['10.1080/09540121.2019.1668531']
509,31957934,Hydrotherapy following breast cancer surgery Phase II trial on hydrotherapy in women following breast cancer surgery.,,2020,,['women following breast cancer surgery'],"['Hydrotherapy', 'hydrotherapy']",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]",[],,0.0380531,,"[{'ForeName': 'Rosana Barbosa Alves', 'Initials': 'RBA', 'LastName': 'Siqueira', 'Affiliation': 'Program of Mastology, Federal University of Goiás, Goiânia, Brazil.'}, {'ForeName': 'Ruffo', 'Initials': 'R', 'LastName': 'Freitas-Junior', 'Affiliation': 'Program of Mastology, Federal University of Goiás, Goiânia, Brazil.'}, {'ForeName': 'Priscila Souza', 'Initials': 'PS', 'LastName': 'Lopes', 'Affiliation': 'Pontifical Catholic University of Goiás, Goiânia, Brazil.'}, {'ForeName': 'Marimília Silva', 'Initials': 'MS', 'LastName': 'Lagares', 'Affiliation': 'Pontifical Catholic University of Goiás, Goiânia, Brazil.'}, {'ForeName': 'Fabiana Pavan', 'Initials': 'FP', 'LastName': 'Viana', 'Affiliation': 'Pontifical Catholic University of Goiás, Goiânia, Brazil.'}, {'ForeName': 'Thamara Marcia Jesus Castro', 'Initials': 'TMJC', 'LastName': 'Mesquita', 'Affiliation': 'Pontifical Catholic University of Goiás, Goiânia, Brazil.'}, {'ForeName': 'Leonardo Ribeiro', 'Initials': 'LR', 'LastName': 'Soares', 'Affiliation': 'Program of Mastology, Federal University of Goiás, Goiânia, Brazil.'}]",The breast journal,['10.1111/tbj.13744']
510,31982882,Feasibility of Online Haemodiafiltration in Sleep Apnoea: A Randomized Crossover Study.,"BACKGROUND
Sleep apnoea is prevalent in dialysis patients. Previous studies identified excessive inflammation in -patients with sleep apnoea. Online haemodiafiltration -(OL-HDF) may reduce systematic inflammation through better clearance of middle molecules. We aimed to determine the feasibility of OL-HDF in sleep apnoea management.
METHODS
Eligible dialysis patients were screened for risk of sleep apnoea by nocturnal oximetry followed by a diagnostic sleep study to assess apnoea-hypopnea index (AHI). Patients with AHI ≥15/h were invited to a randomized crossover trial. The intervention was 2-month high-flux haemodialysis (HF-HD) followed by 2-month OL-HDF or vice versa with 1-month washout via HF-HD. Feasibility was assessed by patient recruitment and the primary outcome, severity of sleep apnoea (AHI). Secondary outcomes were pro-inflammatory cytokines, patient-reported daytime sleepiness, quality of sleep and health-related quality of life.
RESULTS
Of 65 participants at risk of sleep apnoea, only 15 were consented and randomized (mean age 70 years, 80% male, mean AHI 42.2/h). AHI was not statistically different between OL-HDF versus HF-HD (55.6/h vs. 48.3/h, p = 0.134); however, when sleep apnoea was stratified into obstructive and central apnoea, patients had less obstructive episodes after treated by OL-HDF (23.2/h vs. 18.6/h, p = 0.178); a sensitivity analysis was performed excluding outliers, and the treatment effect for obstructive episodes was found to be statistically significant (11.1 vs. 18.2/h, p = 0.019). Pro-inflammatory biomarkers and patient-reported outcomes were similar between OL-HDF and HF-HD.
CONCLUSION
Patient recruitment was a major challenge in this feasibility study. OL-HDF may reduce obstructive sleep apnoea; however, the result needs to be confirmed by larger studies.",2020,"AHI was not statistically different between OL-HDF versus HF-HD (55.6/h vs. 48.3/h, p = 0.134); however, when sleep apnoea was stratified into obstructive and central apnoea, patients had less obstructive episodes after treated by OL-HDF (23.2/h vs. 18.6/h, p = 0.178); a sensitivity analysis was performed excluding outliers, and the treatment effect for obstructive episodes was found to be statistically significant (11.1 vs. 18.2/h, p = 0.019).","['Patients with AHI ≥15/h', '65 participants at risk of sleep apnoea, only 15 were consented and randomized (mean age 70 years, 80% male', 'dialysis patients', 'patients with sleep apnoea', 'Sleep Apnoea', 'Eligible dialysis patients were screened for risk of sleep apnoea by nocturnal oximetry followed by a diagnostic sleep study to assess']","['Online Haemodiafiltration', 'OL-HDF']","['apnoea-hypopnea index (AHI', 'obstructive episodes', 'sleep apnoea', 'pro-inflammatory cytokines, patient-reported daytime sleepiness, quality of sleep and health-related quality of life', 'AHI', 'obstructive sleep apnoea', 'severity of sleep apnoea (AHI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}]","[{'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0520073,"AHI was not statistically different between OL-HDF versus HF-HD (55.6/h vs. 48.3/h, p = 0.134); however, when sleep apnoea was stratified into obstructive and central apnoea, patients had less obstructive episodes after treated by OL-HDF (23.2/h vs. 18.6/h, p = 0.178); a sensitivity analysis was performed excluding outliers, and the treatment effect for obstructive episodes was found to be statistically significant (11.1 vs. 18.2/h, p = 0.019).","[{'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Chu', 'Affiliation': 'Department of Nephrology, Medical and Interventional Services, John Hunter Hospital, Hunter New England Local Health District, Charlestown, New South Wales, Australia, ginger.chu@health.nsw.gov.au.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Suthers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Gemma M', 'Initials': 'GM', 'LastName': 'Paech', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Eyeington', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Medical and Interventional Services, John Hunter Hospital, Hunter New England Local Health District, Charlestown, New South Wales, Australia.'}, {'ForeName': 'Lakshitha', 'Initials': 'L', 'LastName': 'Gunawardhana', 'Affiliation': 'Priority Research Centre for Healthy Lungs, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Kerrin', 'Initials': 'K', 'LastName': 'Palazzi', 'Affiliation': 'Hunter Medical Research Institute, CReDITSS, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'McDonald', 'Affiliation': 'School of Nursing and Midwifery, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Choi', 'Affiliation': 'Department of Nephrology, Medical and Interventional Services, John Hunter Hospital, Hunter New England Local Health District, Charlestown, New South Wales, Australia.'}]",Blood purification,['10.1159/000505572']
511,31982963,"Paravertebral block for percutaneous nephrolithotomy: a prospective, randomized, double-blind placebo-controlled study.","PURPOSE
Percutaneous nephrolithotomy (PCNL) is performed commonly in patients with large kidney stones, but the management of their postoperative pain presents a major challenge. While it is not routinely performed in PCNL patients, paravertebral block (PVB) has been described as an effective strategy for pain control after various non-urologic surgeries. This trial aims to assess the effect of paravertebral blockade on intraoperative and postoperative opioid use as well as postoperative pain control in patients undergoing PCNL.
METHODS
This was a prospective, randomized, double-blind, placebo-controlled study. Patients who consented to participate were randomly assigned to undergo either PVB or a placebo intervention preoperatively. The patient, surgeon, and anesthesia team were all blinded to the randomization. The outcome parameters were intraoperative opioid requirement, postoperative visual analog scale (VAS) pain scores, postoperative opioid use, and postoperative antiemetic use.
RESULTS
23 patients were enrolled in each arm of the study, and the two groups had no significant differences in baseline demographic or clinical characteristics. Patients in the PVB group had significantly lower intraoperative opioid use, postoperative opioid use, frequency of opioid use, and antiemetic. Patients in the PVB group also had lower postoperative VAS pain scores. There were no patients who suffered from complications attributable to PVB.
CONCLUSION
The results of this randomized, double-blind, placebo-controlled trial suggest that PVB should be considered an effective strategy to reduce opioid requirement and improve pain control for patients undergoing PCNL.",2020,"Patients in the PVB group had significantly lower intraoperative opioid use, postoperative opioid use, frequency of opioid use, and antiemetic.","['23 patients', 'patients with large kidney stones', 'patients undergoing PCNL', 'Patients who consented to participate']","['paravertebral blockade', 'Paravertebral block', 'placebo', 'Percutaneous nephrolithotomy (PCNL', 'percutaneous nephrolithotomy', 'placebo intervention preoperatively', 'PVB']","['intraoperative opioid use, postoperative opioid use, frequency of opioid use, and antiemetic', 'postoperative VAS pain scores', 'pain control', 'intraoperative opioid requirement, postoperative visual analog scale (VAS) pain scores, postoperative opioid use, and postoperative antiemetic use']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0542518', 'cui_str': 'Large kidney (finding)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}]",23.0,0.603613,"Patients in the PVB group had significantly lower intraoperative opioid use, postoperative opioid use, frequency of opioid use, and antiemetic.","[{'ForeName': 'Kristin G', 'Initials': 'KG', 'LastName': 'Baldea', 'Affiliation': 'Department of Urology, Loyola University Medical Center, Maywood, IL, 60153, USA.'}, {'ForeName': 'Parth M', 'Initials': 'PM', 'LastName': 'Patel', 'Affiliation': 'Department of Urology, Loyola University Medical Center, Maywood, IL, 60153, USA. Parth.Patel001@lumc.edu.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Delos Santos', 'Affiliation': 'Department of Urology, Loyola University Medical Center, Maywood, IL, 60153, USA.'}, {'ForeName': 'Chandy', 'Initials': 'C', 'LastName': 'Ellimoottil', 'Affiliation': 'Department of Urology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Ahmer', 'Initials': 'A', 'LastName': 'Farooq', 'Affiliation': 'Department of Urology, Loyola University Medical Center, Maywood, IL, 60153, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Mueller', 'Affiliation': 'Department of Urology, Loyola University Medical Center, Maywood, IL, 60153, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Byram', 'Affiliation': 'Department of Anesthesiology, Loyola University Medical Center, Maywood, IL, USA.'}, {'ForeName': 'Thomas M T', 'Initials': 'TMT', 'LastName': 'Turk', 'Affiliation': 'Department of Urology, Loyola University Medical Center, Maywood, IL, 60153, USA.'}]",World journal of urology,['10.1007/s00345-020-03093-3']
512,32406581,"Effect of a water, sanitation and hygiene program on handwashing with soap among household members of diarrhoea patients in healthcare facilities in Bangladesh: a cluster-randomised controlled trial of the CHoBI7 mobile health program.","OBJECTIVE
The Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7) is a water treatment and handwashing with soap intervention for diarrhoea patients and their household members which is initially delivered in a healthcare facility setting. This study evaluated the effectiveness of CHoBI7 program delivery in increasing handwashing with soap in a healthcare facility setting among diarrhoea patients and their household members.
METHODS
A randomised controlled trial of the CHoBI7 program was conducted among 404 diarrhoea patients and their accompanying household members in healthcare facilities in Dhaka, Bangladesh. The 'Standard Message' Arm received the standard message given in Bangladesh to diarrhoea patients on the use of oral rehydration solution. The 'Health Facility Visit + Soapy Water' Arm received the standard message, the CHoBI7 communication module delivered bedside to the patient; and a soapy water bottle in the healthcare facility. The 'Health Facility Visit + Handwashing Station' Arm received this same intervention plus a small plastic handwashing station. Within 24 h of intervention delivery, three-hour structured observation of handwashing practices at stool/vomit- and food-related events (key events) was conducted in healthcare facilities of diarrhoea patients and their accompanying household members.
RESULTS
Compared to the Standard Message Arm, there was significantly more handwashing with soap at key events in both the Health Facility Visit + Soapy Water Arm (51% vs. 25 %) (Odds Ratio: 3.02; (95% Confidence Interval (CI): 1.41, 6.45) and the Health Facility Visit + Handwashing Station Arm (58% vs. 25%) OR: 4.12; (95% CI: 1.86, 9.14).
CONCLUSION
These findings demonstrate that delivery of the CHoBI7 communication module and provision of a soapy water bottle to diarrhoea patients and their accompanying household members presents a promising approach to increase handwashing with soap among this high risk population in a healthcare facility setting in Bangladesh.",2020,"Compared to the Standard Message Arm, there was significantly more handwashing with soap at key events in both the Health Facility Visit + Handwashing Station Arm (58% vs. 25%)","['404 diarrhea patients and their accompanying household members in health facilities in Dhaka, Bangladesh', 'Handwashing with Soap among Household Members of Diarrhea Patients in Health Facilities in Bangladesh']","['CHoBI7 program delivery', 'Water, Sanitation, and Hygiene Program', 'Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7', 'CHoBI7 program']",['Health Facility Visit + Soapy Water Arm'],"[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}]","[{'cui': 'C0008354', 'cui_str': 'Cholera'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]","[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]",404.0,0.0475223,"Compared to the Standard Message Arm, there was significantly more handwashing with soap at key events in both the Health Facility Visit + Handwashing Station Arm (58% vs. 25%)","[{'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'Zohura', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Md Sazzadul Islam', 'Initials': 'MSI', 'LastName': 'Bhuyian', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Saxton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Tahmina', 'Initials': 'T', 'LastName': 'Parvin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shirajum', 'Initials': 'S', 'LastName': 'Monira', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shwapon K', 'Initials': 'SK', 'LastName': 'Biswas', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Jahed', 'Initials': 'J', 'LastName': 'Masud', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Sharika', 'Initials': 'S', 'LastName': 'Nuzhat', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Nowshin', 'Initials': 'N', 'LastName': 'Papri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'M Tasdik', 'Initials': 'MT', 'LastName': 'Hasan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Thomas', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sack', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Perin', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Munirul', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Christine Marie', 'Initials': 'CM', 'LastName': 'George', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13416']
513,31957252,Effects of smelling amniotic fluid on preterm infant's pain and stress during peripheral cannulation: A randomized controlled trial.,"AIM
To investigate the effect of smelling amniotic fluid on preterm infants' pain and stress caused by peripheral cannulation.
METHODS
This was a randomized controlled trial. The study sample consisted of 80 preterm infants meeting the case selection criteria and infants were randomly assigned to each group. However, in addition to the infants excluded from the study, total number of the infants in all the groups was 61. Infants in the amniotic fluid group smelled amniotic fluid for 15 min before, during, and after the application of peripheral cannulation while those in the control group received routine care during the procedure. The Premature Infant Pain Profile was used to assess their pain levels, and salivary cortisol analysis was performed to evaluate stress levels.
RESULTS
Preterm infants in the amniotic fluid and control groups had similar baseline characteristics. However, the pain levels of infants in the amniotic fluid group were significantly lower than of those in the control group during and after the procedure. After the procedure, cortisol levels of the infants in the amniotic fluid group were lower than of those in the control group, although this difference was not significant.
CONCLUSION
The intervention of smelling amniotic fluid is a practice that can be used for reducing pain and stress of preterm infants during peripheral cannulation.",2020,"After the procedure, cortisol levels of the infants in the amniotic fluid group were lower than of those in the control group, although this difference was not significant.
","[""preterm infants' pain and stress caused by peripheral cannulation"", 'preterm infants during peripheral cannulation', '80 preterm infants meeting the case selection criteria and infants', ""preterm infant's pain and stress during peripheral cannulation""]",['smelling amniotic fluid'],"['cortisol levels', 'pain levels, and salivary cortisol analysis', 'pain levels']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0998863', 'cui_str': 'Osmeridae'}, {'cui': 'C0002638', 'cui_str': 'Amniotic Fluid'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",,0.248122,"After the procedure, cortisol levels of the infants in the amniotic fluid group were lower than of those in the control group, although this difference was not significant.
","[{'ForeName': 'Dilek Küçük', 'Initials': 'DK', 'LastName': 'Alemdar', 'Affiliation': 'Nursing Department, Faculty of Health Sciences, Ordu University, Ordu, Turkey.'}, {'ForeName': 'Fatma Güdücü', 'Initials': 'FG', 'LastName': 'Tüfekci', 'Affiliation': 'Pediatric Nursing Department, Nursing Faculty, Ataturk University, Erzurum, Turkey.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12317']
514,31932201,The association of vitamin D with hepatitis B virus replication: Bystander rather than offender.,"BACKGROUND/PURPOSE
Low vitamin D is frequent in hepatitis B virus (HBV)-infected patients and several studies show an inverse association of serum vitamin D level with HBV viral load. However, the causal relationship remains unclear.
METHODS
HBV carriers receiving regular 6-month surveillance without current antiviral treatment or cirrhosis were invited to participate into this trial. The markers of HBV replication included serum HBV DNA and quantitative HBsAg (qHBsAg) levels. Those with undetectable HBV DNA or sufficient vitamin D levels, cancer or electrolyte imbalance were excluded. The eligible subjects were randomized to receive either vitamin D supplement 2000 IU per day for 2 months (vitamin D group) or none (control group).
RESULTS
A total of 196 HBV carriers (93 males and 103 females; mean age 51.9 ± 10.0 years) were screened. Of them, 28 patients had undetectable serum HBV DNA levels, which is defined as spontaneous viral clearance. The vitamin D levels were not different between patients with detectable HBV DNA and those without (p = 0.18). After exclusion, 149 patients were randomized to two groups: 75 in vitamin D group and 74 in control group. After 2 months vitamin D supplement, the serum vitamin D levels were significantly higher in the vitamin D group than the control group (p < 0.001). However, the serum qHBsAg and HBV DNA levels were comparable between these two groups.
CONCLUSION
There is no causal relationship between vitamin D and HBV replication. The role of liver reserve on serum vitamin D levels in patients with chronic HBV infection needs further investigation.",2020,The vitamin D levels were not different between patients with detectable HBV DNA and those without (p = 0.18).,"['HBV carriers receiving regular 6-month surveillance without current antiviral treatment or cirrhosis', 'hepatitis B virus (HBV)-infected patients', '149 patients', '196 HBV carriers (93 males and 103 females; mean age 51.9\xa0±\xa010.0 years) were screened', 'patients with chronic HBV infection needs further investigation']","['vitamin D', 'vitamin D supplement 2000 IU per day for 2 months (vitamin D group) or none (control group']","['vitamin D levels', 'serum qHBsAg and HBV DNA levels', 'serum vitamin D levels', 'undetectable serum HBV DNA levels', 'serum HBV DNA and quantitative HBsAg (qHBsAg) levels', 'spontaneous viral clearance']","[{'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C2363964', 'cui_str': 'Antiviral treatment'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",149.0,0.0402298,The vitamin D levels were not different between patients with detectable HBV DNA and those without (p = 0.18).,"[{'ForeName': 'Chia-Chi', 'Initials': 'CC', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and School of Medicine, Tzu Chi University, Hualien, Taiwan. Electronic address: uld888@yahoo.com.tw.'}, {'ForeName': 'I-Shiang', 'Initials': 'IS', 'LastName': 'Tzeng', 'Affiliation': 'Department of Research, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, New Taipei City, Taiwan.'}, {'ForeName': 'Wei-Chih', 'Initials': 'WC', 'LastName': 'Su', 'Affiliation': 'Department of Gastroenterology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and School of Medicine, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Chung-Hsien', 'Initials': 'CH', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and School of Medicine, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Hans Hsienhong', 'Initials': 'HH', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and School of Medicine, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Chun-Chun', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Department of Laboratory Medicine, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taiwan.'}, {'ForeName': 'Jia-Horng', 'Initials': 'JH', 'LastName': 'Kao', 'Affiliation': 'Graduate Institute of Clinical Medicine and Hepatitis Research Center, National Taiwan University College of Medicine and Hospital, Taiwan.'}]",Journal of the Formosan Medical Association = Taiwan yi zhi,['10.1016/j.jfma.2019.12.004']
515,31980132,Moderators of treatment efficacy in individualized metacognitive training for psychosis (MCT+).,"BACKGROUND AND OBJECTIVES
Individualized Metacognitive Training (MCT+) is a manualized intervention designed to improve delusional severity by reducing delusion-associated cognitive biases such as jumping-to-conclusions. Increased interest in personalized medicine stipulates the identification of patients who are more likely to benefit from specialized interventions. The present study aimed to explore baseline moderators of MCT+ efficacy on delusions and overall positive symptoms in psychosis.
METHODS
We analyzed data from a randomized rater-blind controlled trial, in which 92 patients with psychotic disorders and current or past delusions were randomly assigned to either MCT+ or CogPack®, a cognitive remediation software. Baseline moderator variables consisted of jumping-to-conclusions, cognitive insight, quality of life, self-esteem, selective attention, and patients' attitudes towards their symptoms. Linear mixed-effects models were applied to investigate specific moderators of MCT+ efficacy.
RESULTS
In MCT+ relative to CogPack, presence of a jumping-to-conclusions bias, a lowered decision threshold, and low self-esteem were associated with larger improvements in delusional severity and/or overall positive symptoms over time. Subjective reasoning style and insight, as well as subjective attitudes towards psychosis, did not moderate the treatment efficacy of MCT+ relative to CogPack.
LIMITATIONS
Participation of both treatment groups in group MCT as a part of standard care, possibly leading to additional effects on delusional severity.
CONCLUSIONS
Patients with low self-esteem and those who are prone to jumping-to-conclusions seem to particularly benefit from MCT+. Our results can help inform clinical practice as they provide specific criteria for selecting patients for whom MCT+ is most appropriate.",2020,"Subjective reasoning style and insight, as well as subjective attitudes towards psychosis, did not moderate the treatment efficacy of MCT+ relative to CogPack.
","['psychosis (MCT', 'psychosis', '92 patients with psychotic disorders and current or past delusions']","['individualized metacognitive training', 'MCT+\xa0or CogPack®, a cognitive remediation software', 'MCT', 'Individualized Metacognitive Training (MCT']","['delusional severity', 'delusional severity and/or overall positive symptoms', ""cognitive insight, quality of life, self-esteem, selective attention, and patients' attitudes towards their symptoms""]","[{'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444635', 'cui_str': 'Current or past'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0233820', 'cui_str': 'Self-understanding'}, {'cui': 'C0034380'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",92.0,0.0637505,"Subjective reasoning style and insight, as well as subjective attitudes towards psychosis, did not moderate the treatment efficacy of MCT+ relative to CogPack.
","[{'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Leanza', 'Affiliation': 'University of Basel Psychiatric Hospital, Center for Psychotic Disorders, University of Basel, Switzerland; University of Basel, Department of Psychology, Division of Clinical Psychology and Epidemiology, Basel, Switzerland. Electronic address: letizia.leanza@unibas.ch.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Studerus', 'Affiliation': 'University of Basel, Department of Psychology, Division of Personality and Developmental Psychology, Basel, Switzerland.'}, {'ForeName': 'Vasilis P', 'Initials': 'VP', 'LastName': 'Bozikas', 'Affiliation': '2nd Department of Psychiatry, School of Medicine, Aristotle University of Thessaloniki, Greece.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Andreou', 'Affiliation': 'University of Basel Psychiatric Hospital, Center for Psychotic Disorders, University of Basel, Switzerland.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101547']
516,28163000,"Peri-operative chemotherapy with or without bevacizumab in operable oesophagogastric adenocarcinoma (UK Medical Research Council ST03): primary analysis results of a multicentre, open-label, randomised phase 2-3 trial.","BACKGROUND
Peri-operative chemotherapy and surgery is a standard of care for patients with resectable oesophagogastric adenocarcinoma. Bevacizumab, a monoclonal antibody against VEGF, improves the proportion of patients responding to treatment in advanced gastric cancer. We aimed to assess the safety and efficacy of adding bevacizumab to peri-operative chemotherapy in patients with resectable gastric, oesophagogastric junction, or lower oesophageal adenocarcinoma.
METHODS
In this multicentre, randomised, open-label phase 2-3 trial, we recruited patients aged 18 years and older with histologically proven, resectable oesophagogastric adenocarcinoma from 87 UK hospitals and cancer centres. We randomly assigned patients 1:1 to receive peri-operative epirubicin, cisplatin, and capecitabine chemotherapy or chemotherapy plus bevacizumab, in addition to surgery. Patients in the control group (chemotherapy alone) received three pre-operative and three post-operative cycles of epirubicin, cisplatin, and capecitabine chemotherapy: 50 mg/m 2 epirubicin and 60 mg/m 2 cisplatin on day 1 and 1250 mg/m 2 oral capecitabine on days 1-21. Patients in the investigational group received the same treatment as the control group plus 7·5 mg/kg intravenous bevacizumab on day 1 of every cycle of chemotherapy and for six further doses once every 21 days following chemotherapy, as maintenance treatment. Randomisation was done by means of a telephone call to the Medical Research Council Clinical Trials Unit, where staff used a computer programme that implemented a minimisation algorithm with a random element to establish the allocation for the patient at the point of randomisation. Patients were stratified by chemotherapy centre, site of tumour, and tumour stage. The primary outcome for the phase 3 stage of the trial was overall survival (defined as the time from randomisation until death from any cause), analysed in the intention-to-treat population. Here, we report the primary analysis results of the trial; all patients have completed treatment and the required number of primary outcome events has been reached. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN 46020948, and with ClinicalTrials.gov, number NCT00450203.
FINDINGS
Between Oct 31, 2007, and March 25, 2014, 1063 patients were enrolled and randomly assigned to receive chemotherapy alone (n=533) or chemotherapy plus bevacizumab (n=530). At the time of analysis, 508 deaths were recorded (248 in the chemotherapy alone group and 260 in the chemotherapy plus bevacizumab group). 3-year overall survival was 50·3% (95% CI 45·5-54·9) in the chemotherapy alone group and 48·1% (43·2-52·7) in the chemotherapy plus bevacizumab group (hazard ratio [HR] 1·08, 95% CI 0·91-1·29; p=0·36). Apart from neutropenia no other toxic effects were reported at grade 3 or worse severity in more than 10% of patients in either group. Wound healing complications were more prevalent in the bevacizumab group, occurring in 53 (12%) patients in this group compared with 33 (7%) patients in the chemotherapy alone group. In patients who underwent oesophagogastrectomy, post-operative anastomotic leak rates were higher in the chemotherapy plus bevacizumab group (23 [10%] of 233 in the chemotherapy alone group vs 52 [24%] of 220 in the chemotherapy plus bevacizumab group); therefore, recruitment of patients with lower oesophageal or junctional tumours planned for an oesophagogastric resection was stopped towards the end of the trial. Serious adverse events for all patients included anastomotic leaks (30 events in chemotherapy alone group vs 69 in the chemotherapy plus bevacizumab group), and infections with normal neutrophil count (42 events vs 53).
INTERPRETATION
The results of this trial do not provide any evidence for the use of bevacizumab in combination with peri-operative epiribicin, cisplatin, and capecitabine chemotherapy for patients with resectable gastric, oesophagogastric junction, or lower oesophageal adenocarcinoma. Bevacizumab might also be associated with impaired wound healing.
FUNDING
Cancer Research UK, MRC Clinical Trials Unit at University College London, and F Hoffmann-La Roche Limited.",2017,Apart from neutropenia no other toxic effects were reported at grade 3 or worse severity in more than 10% of patients in either group.,"['patients with resectable gastric, oesophagogastric junction, or lower oesophageal adenocarcinoma', 'patients with resectable oesophagogastric adenocarcinoma', 'Between Oct 31, 2007, and March 25, 2014, 1063 patients', 'patients aged 18 years and older with histologically proven, resectable oesophagogastric adenocarcinoma from 87 UK hospitals and cancer centres', 'Patients were stratified by chemotherapy centre, site of tumour, and tumour stage', 'advanced gastric cancer']","['control group (chemotherapy alone) received three pre-operative and three post-operative cycles of epirubicin, cisplatin, and capecitabine chemotherapy: 50 mg/m 2 epirubicin and 60 mg/m 2 cisplatin on day 1 and 1250 mg/m 2 oral capecitabine', 'bevacizumab', 'control group plus 7·5 mg/kg intravenous bevacizumab', 'chemotherapy alone (n=533) or chemotherapy plus bevacizumab', 'Peri-operative chemotherapy and surgery', 'Bevacizumab', 'peri-operative epirubicin, cisplatin, and capecitabine chemotherapy or chemotherapy plus bevacizumab', 'Peri-operative chemotherapy with or without bevacizumab', 'chemotherapy plus bevacizumab', 'cisplatin, and capecitabine chemotherapy']","['safety and efficacy', 'anastomotic leaks', '3-year overall survival', 'toxic effects', 'Wound healing complications', 'overall survival', 'operative anastomotic leak rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0279628', 'cui_str': 'Adenocarcinoma Of Esophagus'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0475445', 'cui_str': 'Tumor site'}, {'cui': 'C0475455', 'cui_str': 'T category'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",1063.0,0.347846,Apart from neutropenia no other toxic effects were reported at grade 3 or worse severity in more than 10% of patients in either group.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Department of Oncology, Royal Marsden NHS Foundation Trust, London, UK. Electronic address: david.cunningham@rmh.nhs.uk.'}, {'ForeName': 'Sally P', 'Initials': 'SP', 'LastName': 'Stenning', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Smyth', 'Affiliation': 'Department of Oncology, Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Alicia F', 'Initials': 'AF', 'LastName': 'Okines', 'Affiliation': 'Department of Oncology, Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Allum', 'Affiliation': 'Department of Oncology, Royal Marsden NHS Foundation Trust, London, UK; Department of Surgery, Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Rowley', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Stevenson', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Heike I', 'Initials': 'HI', 'LastName': 'Grabsch', 'Affiliation': 'Section of Pathology and Tumour Biology, Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK; Department of Pathology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Alderson', 'Affiliation': 'Department of Surgery, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Crosby', 'Affiliation': 'Department of Clinical Oncology, Velindre Hospital, Cardiff, UK.'}, {'ForeName': 'S Michael', 'Initials': 'SM', 'LastName': 'Griffin', 'Affiliation': 'Northern Oesophagogastric Cancer Unit, Royal Victoria Infirmary, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Wasat', 'Initials': 'W', 'LastName': 'Mansoor', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Fareeda Y', 'Initials': 'FY', 'LastName': 'Coxon', 'Affiliation': 'Department of Oncology, Newcastle Hospitals NHS Foundation Trust, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Falk', 'Affiliation': 'Department of Oncology, Bristol Haematology and Oncology Centre, Bristol, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Darby', 'Affiliation': 'Department of Clinical Oncology, Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Sumpter', 'Affiliation': 'Department of Oncology, Freeman Hospital, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Blazeby', 'Affiliation': 'Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Langley', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(17)30043-8']
517,31955619,Randomized trial of 3-drug combination for lumbar nerve root epidural injections with a TNF-α inhibitor in treatment of lumbar stenosis.,"Background: This study was to assess the clinical efficacy of epidural injections with tumor necrosis factor-alpha (TNF-α) inhibitor in patients with chronic radicular pain caused by lumbar spinal stenosis (LSS). Methods: In a randomized controlled trial (RCT), patients diagnosed with mild-to-moderate LSS underwent epidural intervention with three different drugs and were allocated to TNF-α inhibitor group (Group A), steroid group (Group B) and lidocaine-only group (Group C). All patients were evaluated by visual analog scale (VAS) for leg pain and Oswestry disability index (ODI) to assess function. They all received a 6-month follow-up. Results: Ninety patients were randomly assigned to three groups, for 30 cases in each group. A total of 82 participants (91.1%) completed the follow-up. Pain relief and improvement of movement function after epidural administration in Group A were more significant than those of groups B and C ( p < .05) during the 6-month follow-up, while it showed no significant difference between groups B and C ( p > .05). Conclusions: Our results indicated that epidural administration with TNF-α inhibitor may be a useful conservative method for the treatment of radicular pain caused by LSS. Trial registration: ClinicalTrials.gov Identifier: NCT04062474.",2020,"Pain relief and improvement of movement function after epidural administration in Group A were more significant than those of groups B and C ( p < .05) during the 6-month follow-up, while it showed no significant difference between groups B and C ( p > .05).","['A total of 82 participants (91.1%) completed the follow-up', 'lumbar stenosis', 'patients with chronic radicular pain caused by lumbar spinal stenosis (LSS', 'Ninety patients', 'patients diagnosed with mild-to-moderate LSS underwent']","['TNF-α inhibitor', 'lidocaine-only group', 'epidural intervention', 'steroid', 'epidural injections with tumor necrosis factor-alpha (TNF-α) inhibitor']","['Pain relief and improvement of movement function', 'visual analog scale (VAS) for leg pain and Oswestry disability index (ODI) to assess function']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain (finding)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region (disorder)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0021486', 'cui_str': 'Extradural Injections'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}]",82.0,0.0554314,"Pain relief and improvement of movement function after epidural administration in Group A were more significant than those of groups B and C ( p < .05) during the 6-month follow-up, while it showed no significant difference between groups B and C ( p > .05).","[{'ForeName': 'Peiran', 'Initials': 'P', 'LastName': 'Wei', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qingqiang', 'Initials': 'Q', 'LastName': 'Yao', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}]",British journal of neurosurgery,['10.1080/02688697.2020.1713990']
518,31744812,Wholegrain Particle Size Influences Postprandial Glycemia in Type 2 Diabetes: A Randomized Crossover Study Comparing Four Wholegrain Breads.,"OBJECTIVE
Wholegrain foods vary in the extent of processing. We investigated whether wholegrain particle size in bread influences postprandial glycemia in type 2 diabetes.
RESEARCH DESIGN AND METHODS
Postprandial glycemia (incremental area under the blood glucose curve [iAUC]) was measured after consumption of three breads made with roller-milled wholegrain flour and added grains and a fourth made with stone-ground flour. All flours and grains were 100% wholegrain wheat. Breads were nutrient matched.
RESULTS
Fifteen adults (64 ± 10 years, HbA 1c 58 ± 13 mmol/mol) completed the study. iAUC for the three breads made with roller-milled flour ranged from 376 to 641 mmol -1 min -1 , inverse linear trend for grain particle size P = 0.039. The iAUC for stone-ground wholegrain bread (503) was smaller than predicted from mean particle size.
CONCLUSIONS
Wholegrain structural integrity in bread is a determinant of glycemic response. These findings have implications for dietary advice and the definition of the term ""'wholegrain.""",2020,"The iAUC for stoneground wholegrain bread (503) was smaller than predicted from mean particle size.
","['type 2 diabetes', 'Type 2 Diabetes', 'Fifteen adults (64 ± 10 years, HbA 1c 58 ± 13 mmol/mol) completed the study']","['Wholegrain Particle Size', 'three breads made with roller-milled wholegrain flour and added grains and a fourth made with stoneground flour', 'wholegrain particle size in bread']",['Postprandial glycemia (incremental area under the blood glucose curve [iAUC'],"[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0030608', 'cui_str': 'Particle Size'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C1211818', 'cui_str': 'Rollers'}, {'cui': 'C0599997', 'cui_str': 'Mill (environment)'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0086369', 'cui_str': 'Grain (substance)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",15.0,0.0261251,"The iAUC for stoneground wholegrain bread (503) was smaller than predicted from mean particle size.
","[{'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Reynolds', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand andrew.reynolds@otago.ac.nz.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Elbalshy', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Mete', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Robinson', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Indrawati', 'Initials': 'I', 'LastName': 'Oey', 'Affiliation': 'Riddet Institute, Palmerston North, New Zealand.'}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Silcock', 'Affiliation': 'Department of Food Science, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Nerida', 'Initials': 'N', 'LastName': 'Downes', 'Affiliation': 'Department of Food Science, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Perry', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Te Morenga', 'Affiliation': 'Riddet Institute, Palmerston North, New Zealand.'}]",Diabetes care,['10.2337/dc19-1466']
519,31982585,Effect of a Surgical Teaching Video on Resident Performance of a Laparoscopic Salpingo-oophorectomy: A Randomized Controlled Trial.,"STUDY OBJECTIVE
To assess the effect of a surgical teaching video on junior resident knowledge and performance of a laparoscopic salpingo-oophorectomy (LSO).
DESIGN
Randomized controlled trial.
SETTING
Urban tertiary care academic obstetrics and gynecology department.
PATIENTS
First- and second-year gynecology residents.
INTERVENTIONS
Access to an education video on LSO for 1 week before performing this surgery in the operating room.
MEASUREMENTS AND MAIN RESULTS
Twenty-four junior residents were recruited and randomized to either the educational video group or traditional residency training group. All participants completed a demographic survey and knowledge questionnaire before performing an LSO, which was video-recorded. Video recordings of surgical performance were analyzed using the Objective Structured Assessment of Technical Skills (OSATS; 20 points) and an LSO-specific tool (30 points). Participants completed a self-assessment questionnaire before completing the procedure. The primary outcome measure was the difference in OSATS scores. The secondary outcomes were the knowledge questionnaire scores and self-assessed confidence scores. There were no significant differences between demographic variables of the 2 groups. The primary outcome revealed no significant differences in mean (standard deviation) OSATS scores (10.64 [2.05] vs 11.55 [1.85], p = .3) or LSO-specific tool scores (16.45 [2.68] vs 17.85 [2.63], p = .24). However, there was a significant difference in mean knowledge scores between the video and the traditional training (8.42 [0.79] vs 7.11 [1.36], p = .01) groups. In addition, residents in the video group had more confidence in their knowledge of pelvic anatomy (3.83 [0.39] vs 3.00 [1.00] out of 5.00, p = .04).
CONCLUSION
For junior learners, the use of an LSO video improved knowledge and confidence in anatomy but did not translate to improved surgical performance in the operating room. Surgical videos are a useful adjunct and complement hands-on technical teaching.",2020,"In addition, residents in the video group had more confidence of their knowledge of pelvic anatomy (3.83/5, SD 0.39 vs 3.00, SD 1.00, p=.04).
","['urban tertiary care academic obstetrics and gynecology department', 'Twenty-four residents', 'First and second year gynecology residents']","['laparoscopic salpingo-oophorectomy (LSO', 'Surgical Teaching Video', 'Laparoscopic Salpingo-oophorectomy', 'LSO video', 'educational video group or traditional residency training', 'Access to an education video on LSO', 'surgical teaching video']","['confidence of their knowledge of pelvic anatomy', 'OSATS scores', 'mean knowledge scores', 'mean OSATS scores', 'knowledge questionnaire scores and self-assessed confidence scores', 'surgical performance', 'LSO specific tool scores']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0587480', 'cui_str': 'Obstetrics and gynecology department (environment)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}]","[{'cui': 'C2960363', 'cui_str': 'Laparoscopic salpingo-oophorectomy'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]",24.0,0.143267,"In addition, residents in the video group had more confidence of their knowledge of pelvic anatomy (3.83/5, SD 0.39 vs 3.00, SD 1.00, p=.04).
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Norris', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto (Drs. Norris, Gagnon, Jacobson, Sobel, and Shore).'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Papillon-Smith', 'Affiliation': 'Department of Obstetrics and Gynaecology, McGill University (Dr. Papillon-Smith); Department of Obstetrics and Gynaecology, Royal Victoria Hospital (Dr. Papillon-Smith), Montreal, Quebec, Canada.'}, {'ForeName': 'Louise-Helene', 'Initials': 'LH', 'LastName': 'Gagnon', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto (Drs. Norris, Gagnon, Jacobson, Sobel, and Shore); Department of Obstetrics and Gynaecology, Sunnybrook Health Sciences Centre (Dr. Gagnon).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Jacobson', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto (Drs. Norris, Gagnon, Jacobson, Sobel, and Shore); Department of Obstetrics and Gynaecology, Mount Sinai Hospital (Drs. Jacobson and Sobel).'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Sobel', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto (Drs. Norris, Gagnon, Jacobson, Sobel, and Shore); Department of Obstetrics and Gynaecology, Mount Sinai Hospital (Drs. Jacobson and Sobel).'}, {'ForeName': 'Eliane M', 'Initials': 'EM', 'LastName': 'Shore', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of Toronto (Drs. Norris, Gagnon, Jacobson, Sobel, and Shore); Department of Obstetrics and Gynaecology, Division of Gynecologic Surgery and Pelvic Medicine, St. Michael's Hospital (Dr. Shore), Toronto, Ontario. Electronic address: eliane.shore@unityhealth.to.""}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.01.010']
520,31972630,Effect of High-Intensity Training and Asthma on the V˙O2 Kinetics of Adolescents.,"PURPOSE
High-intensity interval training (HIIT) represents a potent stimulus to the dynamic oxygen uptake (V˙O2) response in adults, but whether the same is evident in youth is unknown. HIIT has also been suggested to place a lower demand on the respiratory system, decreasing the likelihood of exacerbation in those with respiratory conditions, such as asthma.
METHODS
Sixty-nine adolescents (13.6 ± 0.9 yr; 36 asthma) took part, 35 of which (17 asthma) participated in a 30-min HIIT intervention three times a week for 6 months. Each participant completed an incremental ramp test to volitional exhaustion and three heavy-intensity constant work rate tests to determine the dynamic V˙O2, heart rate, and deoxyhemoglobin response at baseline, midintervention, postintervention and at a 3-month follow-up.
RESULTS
There was no influence of asthma at baseline or in response to the intervention. Participants in the intervention group demonstrated a faster V˙O2 time constant (τp) after intervention (intervention: 29.2 ± 5.7 s vs control: 34.2 ± 6.5 s; P = 0.003), with these differences maintained at follow-up (intervention: 32.5 ± 5.5 s vs control: 37.3 ± 8.7 s; P = 0.008). The intervention was associated with a speeding of the concentration of deoxyhemoglobin τ (pre: 20.1 ± 4.7 s vs post: 18.2 ± 4.1 s; P = 0.05) compared with a slowing over the same time period in the control participants (pre: 17.9 ± 4.9 s vs post: 20.1 ± 4.6 s; P = 0.012). Heart rate kinetics were not altered (pre: 46.5 ± 12.2 s vs post: 47.7 ± 11.1 s; P = 0.98).
CONCLUSION
These findings highlight the potential utility of school-based HIIT as a strategy to enhance the V˙O2 kinetics of youth, regardless of the presence of asthma.",2020,"HR kinetics were not altered (Pre: 46.5±12.2 vs. Post: 47.7±11.1 s; P=0.98).
","['Adolescents', 'Sixty-nine adolescents (13.6±0.9 years; 36 asthma) took part, 35 of which (17 asthma']","['High-Intensity Training and Asthma', 'High-intensity interval training (HIIT']","['dynamic oxygen uptake (V[Combining Dot Above]O2), heart rate (HR) and deoxyhaemoglobin ([HHb]) response', 'faster V[Combining Dot Above]O2 time constant', 'HR kinetics']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0057437', 'cui_str': 'T-state hemoglobin'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]",69.0,0.0213114,"HR kinetics were not altered (Pre: 46.5±12.2 vs. Post: 47.7±11.1 s; P=0.98).
","[{'ForeName': 'Melitta A', 'Initials': 'MA', 'LastName': 'McNarry', 'Affiliation': 'Applied Sports Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering, Bay Campus, Swansea University, Swansea, UNITED KINGDOM.'}, {'ForeName': 'Charles O N', 'Initials': 'CON', 'LastName': 'Winn', 'Affiliation': 'Applied Sports Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering, Bay Campus, Swansea University, Swansea, UNITED KINGDOM.'}, {'ForeName': 'Gwyneth A', 'Initials': 'GA', 'LastName': 'Davies', 'Affiliation': 'Swansea University Medical School, Singleton Campus, Swansea University, Swansea, UNITED KINGDOM.'}, {'ForeName': 'William T B', 'Initials': 'WTB', 'LastName': 'Eddolls', 'Affiliation': 'Applied Sports Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering, Bay Campus, Swansea University, Swansea, UNITED KINGDOM.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Mackintosh', 'Affiliation': 'Applied Sports Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering, Bay Campus, Swansea University, Swansea, UNITED KINGDOM.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002270']
521,31977640,Pectin-Alginate Does Not Further Enhance Exogenous Carbohydrate Oxidation in Running.,"PURPOSE
Maximizing carbohydrate availability is important for many endurance events. Combining pectin and sodium alginate with ingested maltodextrin-fructose (MAL + FRU + PEC + ALG) has been suggested to enhance carbohydrate delivery via hydrogel formation, but the influence on exogenous carbohydrate oxidation remains unknown. The primary aim of this study was to assess the effects of MAL + FRU + PEC + ALG on exogenous carbohydrate oxidation during exercise compared with a maltodextrin-fructose mixture (MAL + FRU). MAL + FRU has been well established to increase exogenous carbohydrate oxidation during cycling compared with glucose-based carbohydrates (MAL + GLU). However, much evidence focuses on cycling, and direct evidence in running is lacking. Therefore, a secondary aim was to compare exogenous carbohydrate oxidation rates with MAL + FRU versus MAL + GLU during running.
METHODS
Nine trained runners completed two trials (MAL + FRU and MAL + FRU + PEC + ALG) in a double-blind, randomized crossover design. A subset (n = 7) also completed a MAL + GLU trial to address the secondary aim, and a water trial to establish background expired CO2 enrichment. Participants ran at 60% V˙O2peak for 120 min while ingesting either water only or carbohydrate solutions at a rate of 1.5 g carbohydrate per minute.
RESULTS
At the end of 120 min of exercise, exogenous carbohydrate oxidation rates were 0.9 (SD 0.5) g·min with MAL + GLU ingestion. MAL + FRU ingestion increased exogenous carbohydrate oxidation rates to 1.1 (SD 0.3) g·min (P = 0.038), with no further increase with MAL + FRU + PEC + ALG ingestion (1.1 (SD 0.3) g·min; P = 1.0). No time-treatment interaction effects were observed for plasma glucose, lactate, insulin, or nonesterified fatty acids, or for ratings of perceived exertion or gastrointestinal symptoms (all, P > 0.05).
CONCLUSION
To maximize exogenous carbohydrate oxidation during moderate-intensity running, athletes may benefit from consuming glucose(polymer)-fructose mixtures over glucose-based carbohydrates alone, but the addition of pectin and sodium alginate offers no further benefit.",2020,"No time x treatment interaction effects were observed for plasma glucose, lactate, insulin or non-esterified fatty acids, nor for ratings of perceived exertion or gastrointestinal symptoms (all p>0.05).
",['Nine trained runners completed two trials'],"['Pectin-Alginate', 'maltodextrin-fructose mixture (MAL+FRU', 'MAL+FRU versus MAL+GLU', 'MAL+FRU+PEC+ALG', 'MAL+FRU', 'pectin and sodium alginate with ingested maltodextrin-fructose (MAL+FRU+PEC+ALG', 'MAL+FRU ingestion', 'MAL+FRU and MAL+FRU+PEC+ALG']","['Exogenous Carbohydrate Oxidation', 'exogenous carbohydrate oxidation rates', 'exogenous carbohydrate oxidation', 'plasma glucose, lactate, insulin or non-esterified fatty acids, nor for ratings of perceived exertion or gastrointestinal symptoms']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0070203', 'cui_str': 'pectin'}, {'cui': 'C0102137', 'cui_str': 'alginate'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0391940', 'cui_str': 'Fructose measurement (procedure)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0142791', 'cui_str': 'Sodium alginate'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0369212', 'cui_str': 'Fatty Acids, Esterified'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}]",,0.0628111,"No time x treatment interaction effects were observed for plasma glucose, lactate, insulin or non-esterified fatty acids, nor for ratings of perceived exertion or gastrointestinal symptoms (all p>0.05).
","[{'ForeName': 'James F P', 'Initials': 'JFP', 'LastName': 'Barber', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Narang', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hengist', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'Gareth A', 'Initials': 'GA', 'LastName': 'Wallis', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UNITED KINGDOM.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002262']
522,31961756,Ability of Layperson Callers to Apply a Tourniquet Following Protocol-Based Instructions From an Emergency Medical Dispatcher.,"Introduction : One of the greatest casualty-care improvements resulting from US military operations in Iraq and Afghanistan has been the reduction of preventable death from massive extremity hemorrhage - largely due to the widespread use of limb tourniquets. More recently, tourniquet use in civilian, prehospital settings has shown promise in reducing deaths in cases of catastrophic arterial limb hemorrhage. Telephone instructions by trained emergency medical dispatchers (EMDs) on applying an available tourniquet may help achieve such a benefit. Objectives : The objective of the study was to determine whether layperson callers can effectively stop simulated bleeding using an improvised or a commercial tourniquet, when provided with scripted instructions via phone from a trained protocol-aided EMD. Methods : This was a prospective, randomized trial involving layperson volunteers, done at four locations in Salt Lake City, Utah, USA. Volunteers were assigned randomly to three groups: one for each of two commonly available commercial tourniquets and one for an improvised tourniquet. Results : A total of 246 subjects participated in the study at the four locations between February 11, 2019 and June 22, 2019. The overall median time for all trials (i.e., elapsed time from the start to the end of the simulation) was 3 minutes and 19 seconds. Median time to stop the bleeding (i.e., elapsed time from the start of the simulation to the time the participant was able to successfully stop the bleeding) was 2 minutes and 57 seconds. Median tourniquet pressure was 256 mmHg and median-end blood loss was 1,365 mL. A total of 198 participants (80.49%) were able to completely stop the bleeding while 16 participants (6.5%) had the tourniquet applied with some bleeding still occurring, and 32 participants (13.01%) exceeded the threshold of 2,500 mL of blood loss, resulting in the ""patient"" not surviving. Conclusions : The study findings demonstrated that untrained bystanders provided with instructions via phone from a trained Emergency Medical Dispatcher applied a tourniquet and successfully stopped the bleeding completely in most cases.",2020,The study findings demonstrated that untrained bystanders provided with instructions via phone from a trained Emergency Medical Dispatcher applied a tourniquet and successfully stopped the bleeding completely in most cases.,"['246 subjects participated in the study at the four locations between February 11, 2019 and June 22, 2019', 'layperson volunteers, done at four locations in Salt Lake City, Utah, USA', 'Iraq and Afghanistan', 'A total of 198 participants (80.49%) were able to completely stop the bleeding while 16 participants (6.5%) had the tourniquet applied with some bleeding still occurring, and 32 participants (13.01%) exceeded the threshold of 2,500\u2009mL of blood loss, resulting in the ""patient"" not surviving']","['Telephone instructions by trained emergency medical dispatchers (EMDs', 'commercial tourniquets and one for an improvised tourniquet']","['Median tourniquet pressure', 'Median time to stop the bleeding', 'overall median time']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0337049', 'cui_str': 'Lakes'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0042124', 'cui_str': 'Utah'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C4277717', 'cui_str': 'Emergency Medical Dispatcher'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",246.0,0.0398299,The study findings demonstrated that untrained bystanders provided with instructions via phone from a trained Emergency Medical Dispatcher applied a tourniquet and successfully stopped the bleeding completely in most cases.,"[{'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Scott', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Olola', 'Affiliation': ''}, {'ForeName': 'Marie Isabel', 'Initials': 'MI', 'LastName': 'Gardett', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ashwood', 'Affiliation': ''}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Broadbent', 'Affiliation': ''}, {'ForeName': 'Srilakshmi', 'Initials': 'S', 'LastName': 'Sangaraju', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stiegler', 'Affiliation': ''}, {'ForeName': 'Mark Conrad', 'Initials': 'MC', 'LastName': 'Fivaz', 'Affiliation': ''}, {'ForeName': 'Jeff J', 'Initials': 'JJ', 'LastName': 'Clawson', 'Affiliation': ''}]",Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors,['10.1080/10903127.2020.1718259']
523,31957794,Effectiveness of Proactive Tobacco Cessation Treatment Outreach Among Smokers With Serious Mental Illness.,"INTRODUCTION
People with serious mental illness (SMI) have a high smoking prevalence and low quit rates. Few cessation treatments are tested in smokers with SMI. Mental health (MH) providers are reluctant to address smoking. Proactive tobacco cessation treatment strategies reach out directly to smokers to offer counseling and medication and improve treatment utilization and quit rates. The current study is a secondary analysis of a randomized controlled trial of proactive outreach for tobacco cessation treatment in VA MH patients.
AIMS AND METHODS
Participants (N = 1938, 83% male, mean age 55.7) across four recruitment sites, who were current smokers and had a MH visit in the past 12 months, were identified using the electronic medical record. Participants were randomized to Intervention (telephone outreach call plus invitation to engage in MH tailored telephone counseling and assistance obtaining nicotine replacement therapy) or Control (usual care). The current study assessed outcomes in participants with SMI (N = 982).
RESULTS
Compared to the Control group, participants assigned to the Intervention group were more likely to engage in telephone counseling (22% vs. 3%) and use nicotine replacement therapy (51% vs. 41%). Participants in the Intervention group were more likely to be abstinent (7-day point prevalence; 18%) at 12 months than participants in the Control group (11%) but equally likely to make quit attempts.
CONCLUSIONS
Proactive tobacco cessation treatment is an effective strategy for tobacco users with SMI. Proactive outreach had a particularly strong effect on counseling utilization. Future randomized clinical trials examining proactive tobacco treatment approaches in SMI treatment settings are needed.
IMPLICATIONS
Few effective treatment models exist for smokers with SMI. Proactive tobacco cessation outreach with connections to MH tailored telephone counseling and medication promotes tobacco abstinence among smokers with SMI and is an effective treatment strategy for this underserved population.",2020,"Participants in the Intervention group were more likely to be abstinent (7-day point prevalence; 18%) at 12 months than participants in the Control group; 11%) but equally likely to make quit attempts.
","['People with serious mental illness (SMI', 'VA MH patients', 'tobacco users with SMI', 'Participants (N=1938, 83% male, mean age 55.7) across 4 recruitment sites, who were current smokers and had a MH visit in the past 12 months, were identified using the electronic medical record', 'participants with SMI (N=982', 'smokers with serious mental illness', 'smokers with SMI']","['Proactive outreach', 'Intervention (telephone outreach call plus invitation to engage in MH tailored telephone counseling and assistance obtaining nicotine replacement therapy [NRT]) or Control (usual care', 'Proactive tobacco cessation treatment', 'proactive outreach', 'Proactive tobacco cessation', 'Proactive tobacco cessation outreach with connections to mental health tailored telephone counseling and medication promotes tobacco abstinence', 'proactive tobacco cessation outreach']",['likely to engage in telephone counseling'],"[{'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853727', 'cui_str': 'Tobacco user (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3241966'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]","[{'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",,0.0563733,"Participants in the Intervention group were more likely to be abstinent (7-day point prevalence; 18%) at 12 months than participants in the Control group; 11%) but equally likely to make quit attempts.
","[{'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Japuntich', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, Hennepin Healthcare, Minneapolis, MN.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Hammett', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Rogers', 'Affiliation': 'Department of Medicine, VA New York Harbor Healthcare System, New York, NY.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Burgess', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'El Shahawy', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Melzer', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Noorbaloochi', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Krebs', 'Affiliation': 'Department of Mental Health, VA San Diego Healthcare System, San Diego, CA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'Department of Medicine, VA New York Harbor Healthcare System, New York, NY.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa013']
524,27835713,"Psychotherapy for Depression in Older Veterans Via Telemedicine: Effect on Quality of Life, Satisfaction, Treatment Credibility, and Service Delivery Perception.","OBJECTIVE
To analyze the impact of telepsychology and same-room care on functioning, satisfaction, and perception of care based on a noninferiority trial of psychotherapy delivered via telemedicine or same-room care to elderly patients with depression.
METHODS
241 elderly patients with depression (meeting DSM-IV diagnostic criteria) were randomly assigned to either telemedicine (n = 120) or same-room treatment (n = 121) between April 1, 2007, and July 31, 2011. The primary outcomes included quality of life (36-item Short Form Survey [SF-36]), satisfaction (Charleston Psychiatric Outpatient Satisfaction Scale), treatment credibility, and service delivery perception scores obtained at 4 weeks, 8 weeks, 3 months, and 12 months. Comparisons of intervention means were carried out at each time point using independent sample t tests and SAS Procedure MIANALYZE to combine results across the multiply imputed complete data sets. If significant differences were detected for a given outcome within a domain, a Bonferroni correction was applied to determine if significance was maintained.
RESULTS
None of the SF-36 scores showed a significant difference between the 2 treatment groups by the end of the study period, with little significance shown throughout the intermediate time points. Similarly, over all time points, there was no statistically significant difference in patient satisfaction or treatment credibility.
CONCLUSIONS
This study found that telemedicine is a viable alternative modality for providing evidence-based psychotherapy for elderly patients with depression. Results provide evidence that quality of life and satisfaction with care are not adversely influenced by the decision to use a telehealth modality instead of in-person treatment, and, as a result, resources can be devoted to offering services in patients' homes through telemedicine.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT00324701.",2016,"None of the SF-36 scores showed a significant difference between the 2 treatment groups by the end of the study period, with little significance shown throughout the intermediate time points.","['241 elderly patients with depression (meeting DSM-IV diagnostic criteria', 'Older Veterans', 'n = 120) or same-room treatment (n = 121) between April 1, 2007, and July 31, 2011', ""patients' homes through telemedicine"", 'elderly patients with depression']","['Telemedicine', 'telemedicine', 'telepsychology and same-room care', 'psychotherapy delivered via telemedicine', 'Psychotherapy']","['patient satisfaction or treatment credibility', 'Quality of Life, Satisfaction, Treatment Credibility, and Service Delivery Perception', 'quality of life (36-item Short Form Survey [SF-36]), satisfaction (Charleston Psychiatric Outpatient Satisfaction Scale), treatment credibility, and service delivery perception scores', 'SF-36 scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",121.0,0.0664085,"None of the SF-36 scores showed a significant difference between the 2 treatment groups by the end of the study period, with little significance shown throughout the intermediate time points.","[{'ForeName': 'Leonard E', 'Initials': 'LE', 'LastName': 'Egede', 'Affiliation': 'Center for Health Disparities Research, Medical University of South Carolina, 135 Rutledge Ave, Room 280G, Charleston, SC 29425-0593. egedel@musc.edu.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Acierno', 'Affiliation': 'Health Equity and Rural Outreach Innovation Center (HEROIC), Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina, USA.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Knapp', 'Affiliation': 'Health Equity and Rural Outreach Innovation Center (HEROIC), Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina, USA.'}, {'ForeName': 'Rebekah J', 'Initials': 'RJ', 'LastName': 'Walker', 'Affiliation': 'Health Equity and Rural Outreach Innovation Center (HEROIC), Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina, USA.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Payne', 'Affiliation': 'Health Equity and Rural Outreach Innovation Center (HEROIC), Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina, USA.'}, {'ForeName': 'B Christopher', 'Initials': 'BC', 'LastName': 'Frueh', 'Affiliation': 'Department of Psychology, University of Hawaii, Hilo, Hawaii, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.16m10951']
525,31922999,Effect of Midazolam in Addition to Propofol and Opiate Sedation on the Quality of Recovery After Colonoscopy: A Randomized Clinical Trial.,"BACKGROUND
There is a concern that midazolam, when used as a component of sedation for colonoscopy, may impair cognition and prolong recovery. We aimed to identify whether midazolam produced short- and longer-term effects on multiple dimensions of recovery including cognition.
METHODS
A 2-center double-blinded, placebo-controlled, parallel-group, randomized, phase IV study with a 1:1 allocation ratio was conducted in adults ≥18 years of age undergoing elective outpatient colonoscopy, with sufficient English language proficiency to complete the Postoperative Quality of Recovery Scale (PostopQRS). Participants were administered either midazolam (0.04 mg·kg) or an equivalent volume of 0.9% saline before sedation with propofol with or without an opiate. The primary outcome was incidence of recovery in the cognitive domain of the PostopQRS on day 3 after colonoscopy, which was analyzed using a χ test. Secondary outcomes included recovery in other domains of the PostopQRS over time, time to eye-opening, and hospital stay, and patient and endoscopist satisfaction. All hypotheses were defined before recruitment.
RESULTS
During September 2015 to June 2018, 406 patients were allocated to either midazolam (n = 201) or placebo (n = 205), with one withdrawn before allocation. There was no significant difference in recovery in the cognitive domain of the PostopQRS on day 3 after colonoscopy (midazolam 86.8% vs placebo 88.7%, odds ratio, 0.838; 95% confidence interval [CI], 0.42-1.683; P= .625). Furthermore, there was no difference in recovery over time in the cognitive domain of the PostopQRS (P = .534). Overall recovery of the PostopQRS increased over time but was not different between groups. Furthermore, there were no differences between groups for nociceptive, emotive, activities-of-daily-living domains of the PostopQRS. Patient and endoscopist satisfaction were high and not different. There were no differences in time to eye-opening (midazolam 9.4 ± 12.8 minutes vs placebo 7.3 ± 0.7 minutes; P = .055), or time to hospital discharge (midazolam 103.4 ± 1.4 minutes vs placebo 98.4 ± 37.0 minutes; P = .516).
CONCLUSIONS
The addition of midazolam 0.04 mg·kg as adjunct to propofol and opiate sedation for elective colonoscopy did not show evidence of any significant differences in recovery in the cognitive domain of the PostopQRS, overall quality of recovery as measured by the PostopQRS, or emergence and hospital discharge times. The use of midazolam should be determined by the anesthesiologist.",2020,"Furthermore, there were no differences between groups for nociceptive, emotive, activities-of-daily-living domains of the PostopQRS.","['During September 2015 to June 2018, 406 patients', 'adults ≥18 years of age undergoing elective outpatient colonoscopy, with sufficient English language proficiency to complete the Postoperative Quality of Recovery Scale (PostopQRS']","['midazolam', 'equivalent volume of 0.9% saline before sedation with propofol with or without an opiate', 'Midazolam', 'placebo', 'Propofol and Opiate Sedation']","['Overall recovery of the PostopQRS', 'recovery in other domains of the PostopQRS over time, time to eye-opening, and hospital stay, and patient and endoscopist satisfaction', 'nociceptive, emotive, activities-of-daily-living domains of the PostopQRS', 'cognitive domain of the PostopQRS, overall quality of recovery as measured by the PostopQRS, or emergence and hospital discharge times', 'incidence of recovery in the cognitive domain of the PostopQRS on day 3 after colonoscopy', 'time to hospital discharge', 'Patient and endoscopist satisfaction', 'cognitive domain of the PostopQRS', 'time to eye-opening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0376245', 'cui_str': 'English language (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0222045'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]",406.0,0.627951,"Furthermore, there were no differences between groups for nociceptive, emotive, activities-of-daily-living domains of the PostopQRS.","[{'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Gurunathan', 'Affiliation': 'From the *The Prince Charles Hospital, Brisbane, Queensland, Australia †University of Queensland, Brisbane, Queensland, Australia ‡Queensland University of Technology and University of Sunshine Coast, Queensland, Australia §Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia ‖Department of Anesthesia and Pain Management, The Royal Melbourne Hospital, Melbourne, Victoria, Australia ¶Outcomes Research Consortium, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Rahman', 'Affiliation': ''}, {'ForeName': 'Zelda', 'Initials': 'Z', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Vandeleur', 'Affiliation': ''}, {'ForeName': 'Sweta', 'Initials': 'S', 'LastName': 'Sriram', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Harch', 'Affiliation': ''}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Boggett', 'Affiliation': ''}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bowyer', 'Affiliation': ''}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Royse', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004620']
526,31373077,Comparing cannula-based subcision with the common needle method: A clinical trial.,"OF TRIAL DESIGN
Treatment of depressed acne scars requires multiple modalities. Although needle subcision is a valuable method, it exhibits mild to moderate efficacy in treatment of deep acne scars owing to the high recurrence rate and other side effects. A total of 100 patients with rolling acne scars were randomly treated using the standard technique of 18 gauge cannula and 27 gauge needle subcision in two parallel groups, and the effect of cannula subcision instead of needle subcision was evaluated in the treatment of rolling acne scars.
METHODS
A total of 100 patients were randomly treated using the standard technique of 18 gauge cannula and 27 gauge needle subcision. The outcomes of these procedures were assessed by three blinded dermatologists and by patients' satisfaction.
RESULTS
Subcision using the cannula showed good and very good improvement in about 83% of patients (n = 50, P < .05) based on dermatologists investigation and almost no side effects were observed in compared with needle subcision. The response rate was significantly different while using cannula subcision.
CONCLUSION
Cannula subcision appears to be a safe and practical technique that can enhance the efficacy of subcision without considerable complications.",2020,"RESULTS
Subcision using the cannula showed good and very good improvement in about 83% of patients (n = 50, P ","['100 patients', '100 patients with rolling acne scars']","['cannula subcision instead of needle subcision', 'standard technique of 18 gauge cannula and 27 gauge needle subcision', 'cannula-based subcision']","['response rate', 'side effects']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0423783', 'cui_str': 'Acne scar (disorder)'}]","[{'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}]",100.0,0.0149249,"RESULTS
Subcision using the cannula showed good and very good improvement in about 83% of patients (n = 50, P ","[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Nilforoushzadeh', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Lotfi', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Heidari-Kharaji', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Nickhah', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Alavi', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Mahmoudbeyk', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI),['10.1111/srt.12761']
527,31914963,Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis.,"BACKGROUND
The two 52-week INPULSIS trials investigated nintedanib versus placebo in patients with IPF, FVC ≥50% predicted and DLco 30-79% predicted. The 24-week INSTAGE trial investigated nintedanib plus sildenafil versus nintedanib alone in patients with IPF and DLco ≤35% predicted. We used data from INPULSIS and INSTAGE to compare the effects of nintedanib in patients with IPF with less versus more severe impairment in gas exchange at baseline.
METHODS
Analyses were conducted in patients treated with nintedanib alone in the INPULSIS and INSTAGE trials and in patients treated with placebo in the INPULSIS trials. Outcomes included the rate of decline in FVC over 24 weeks, the proportions of patients who had a confirmed or suspected idiopathic acute exacerbation over 24 weeks, deaths over 24 weeks, and adverse events. Analyses were descriptive.
RESULTS
In total, 638 and 136 patients received nintedanib alone in the INPULSIS and INSTAGE trials, respectively, and 423 patients received placebo in the INPULSIS trials. Rates of FVC decline were - 52.3 and - 66.7 mL/24 weeks in patients treated with nintedanib alone in INPULSIS and INSTAGE, respectively, and - 102.8 mL/24 weeks in patients treated with placebo in INPULSIS. Confirmed or suspected idiopathic acute exacerbations were reported in 0.6 and 3.7% of patients treated with nintedanib alone in INPULSIS and INSTAGE, respectively, and 2.1% of patients treated with placebo in INPULSIS. Deaths occurred in 2.0, 11.0 and 1.9% of patients in these groups, respectively. Diarrhoea adverse events were reported in 52.5 and 48.5% of patients treated with nintedanib alone in INPULSIS and INSTAGE, respectively, and 16.1% of patients treated with placebo in INPULSIS.
CONCLUSIONS
Based on data from the INSTAGE and INPULSIS trials, nintedanib had a similar effect on FVC decline over 24 weeks, and a similar safety and tolerability profile, in patients with IPF and more versus less severe impairment in gas exchange. These data support the use of nintedanib in patients with IPF who have advanced disease.
TRIAL REGISTRATION
INPULSIS (NCT01335464 and NCT01335477); INSTAGE (NCT02802345).",2020,"Diarrhoea adverse events were reported in 52.5 and 48.5% of patients treated with nintedanib alone in INPULSIS and INSTAGE, respectively, and 16.1% of patients treated with placebo in INPULSIS.
","['patients with advanced idiopathic pulmonary fibrosis', 'patients with IPF, FVC ≥50% predicted and DLco 30-79% predicted', 'patients with IPF who have advanced disease', 'patients with IPF and DLco ≤35% predicted', 'In total, 638 and 136 patients received', 'patients with IPF with less versus more severe impairment in gas exchange at baseline']","['nintedanib alone', 'nintedanib versus placebo', 'nintedanib', 'placebo', 'nintedanib plus sildenafil']","['rate of decline in FVC', 'Diarrhoea adverse events', 'safety and tolerability profile', 'Rates of FVC decline', 'Efficacy and safety', 'Deaths', 'FVC decline', 'adverse events', 'suspected idiopathic acute exacerbations', 'suspected idiopathic acute exacerbation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}]",,0.0873364,"Diarrhoea adverse events were reported in 52.5 and 48.5% of patients treated with nintedanib alone in INPULSIS and INSTAGE, respectively, and 16.1% of patients treated with placebo in INPULSIS.
","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Richeldi', 'Affiliation': 'Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy. luca.richeldi@policlinicogemelli.it.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kolb', 'Affiliation': ""McMaster University and St. Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Jouneau', 'Affiliation': 'Hôpital Pontchaillou - CHU de Rennes, IRSET UMR 1085, Université de Rennes 1, Rennes, France.'}, {'ForeName': 'Wim A', 'Initials': 'WA', 'LastName': 'Wuyts', 'Affiliation': 'Unit for Interstitial Lung Diseases, Department of Respiratory Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Schinzel', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Stowasser', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Quaresma', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'University of Washington, Seattle, USA.'}]",BMC pulmonary medicine,['10.1186/s12890-019-1030-4']
528,31927162,"A randomized clinical trial of motivational interviewing plus skills training vs. Relaxation plus education and 12-Steps for substance using incarcerated youth: Effects on alcohol, marijuana and crimes of aggression.","BACKGROUND
Motivational Interviewing plus Cognitive Behavior Therapy (MI/CBT) has been used to reduce adolescent substance use, but has rarely been applied in youth correctional settings. This trial compared MI/CBT against Relaxation Training plus Substance-Education/12-Steps (RT/SET) to reduce substance use and crime among incarcerated youth.
METHODS
Participants (N = 199) were incarcerated juveniles (64.8 % non-White, 10.1 % girls, mean age of 17.1 years). Two individual sessions of MI (or RT) were followed by 10 group sessions of CBT (or SET). Youth were randomized to condition with follow-ups at 3- and 6-months after release. Major outcomes included alcohol, marijuana and crimes involving aggression.
RESULTS
A marginal treatment by time interaction was found for percent heavy drinking days, with follow-up tests indicating less alcohol use in RT/SET than MI/CBT at 6 months, and increased use within MI/CBT from 3 to 6 months. A significant treatment by time interaction was found for alcohol-related predatory aggression, with follow-up tests indicating fewer youth engaged in this behavior from 3 to 6 months within RT/SET, and weak evidence favoring MI/CBT over RT/SET at 3 months. General predatory aggression decreased from 3 to 6-months for both treatments.
CONCLUSIONS
Although weak evidence was found favoring MI/CBT with respect to alcohol-related predatory aggression, results generally support RT/SET in reducing percent heavy drinking days.",2020,"A marginal treatment by time interaction was found for percent heavy drinking days, with follow-up tests indicating less alcohol use in RT/SET than MI/CBT at 6 months, and increased use within MI/CBT from 3 to 6 months.","['Participants (N\u202f=\u202f199) were incarcerated juveniles (64.8 % non-White, 10.1 % girls, mean age of 17.1 years']","['MI (or RT', 'Motivational Interviewing plus Cognitive Behavior Therapy (MI/CBT', 'motivational interviewing plus skills training vs. Relaxation plus education and 12-Steps for substance using incarcerated youth', 'MI/CBT against Relaxation Training plus Substance-Education/12-Steps (RT/SET']","['alcohol, marijuana and crimes involving aggression', 'General predatory aggression']","[{'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}, {'cui': 'C3146221', 'cui_str': 'Juvenile (finding)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0010325', 'cui_str': 'Crime'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.0213278,"A marginal treatment by time interaction was found for percent heavy drinking days, with follow-up tests indicating less alcohol use in RT/SET than MI/CBT at 6 months, and increased use within MI/CBT from 3 to 6 months.","[{'ForeName': 'L A R', 'Initials': 'LAR', 'LastName': 'Stein', 'Affiliation': 'Department of Psychology, The University of Rhode Island, 130 Flagg Road, Kingston, RI 02881, United States; Center for Alcohol & Addiction Studies, Brown University, Brown University, Box G-S121-5, 121 South Main Street, Providence, RI 02912, United States; Department of Behavioral & Social Sciences, Brown University, Box G-S121-4, 121 South Main Street, Providence, RI 02912, United States; Rhode Island Training School, 300 New London Avenue, Cranston, RI 02920, United States. Electronic address: larstein@uri.edu.'}, {'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, Brown University, Box G-S121-5, 121 South Main Street, Providence, RI 02912, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Clair-Michaud', 'Affiliation': 'Rhode Island Training School, 300 New London Avenue, Cranston, RI 02920, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lebeau', 'Affiliation': 'Rhode Island Executive Office of Health & Human Services, 3 West Road, Cranston, RI 02920, United States.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Hurlbut', 'Affiliation': 'Administration of Justice, Salve Regina University, 100 Ochre Street, Newport, RI 02840, United States.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, Brown University, Box G-S121-5, 121 South Main Street, Providence, RI 02912, United States; Department of Behavioral & Social Sciences, Brown University, Box G-S121-4, 121 South Main Street, Providence, RI 02912, United States.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Monti', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, Brown University, Box G-S121-5, 121 South Main Street, Providence, RI 02912, United States.'}, {'ForeName': 'Damaris', 'Initials': 'D', 'LastName': 'Rohsenow', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, Brown University, Box G-S121-5, 121 South Main Street, Providence, RI 02912, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107774']
529,31932932,"Analgesic effect of postoperative laparoscopic-guided transversus abdominis plane (TAP) block, associated with preoperative port-site infiltration, within an enhanced recovery after surgery protocol in one-anastomosis gastric bypass: a randomized clinical trial.","BACKGROUND
The use of ultrasonography to assist needle placement during transverse abdominal plane (TAP) technique has provided direct visualization of surround anatomical musculature and facial planes. However, the increased girth in patients undergoing bariatric surgery is challenging to visualize via ultrasonography which may lead to poor postoperative analgesia.
OBJECTIVE
The aim of the study is to investigate whether the addition of postoperative laparoscopic-guided TAP block as part of a multimodal analgesic regimen within the ERAS protocol compared to no block provides better postoperative analgesia in patients undergoing one-anastomosis gastric bypass surgery.
PATIENTS AND METHODS
A prospective clinical trial was performed. Patients were randomized into two groups: patients undergoing postoperative laparoscopic-guided TAP (TAP-lap) and patients not receiving TAP-lap (Control). Multimodal analgesia included preoperative port-site infiltration with Bupivacaine 0.25% in both groups and systemic Acetaminophen. Pain quantification as measured by visual analogic scale (VAS) was assessed at 6 and 24 h after surgery, and 24-h postoperative opioid consumption.
RESULTS
One hundred and forty patients were included, 70 in each group. The mean operation time was 78.5 ± 14.4 min in TAP-lap and 75.9 ± 15.6 min in Control (NS). The mean postoperative pain, as measured by VAS, 6 h after surgery was 23.1 ± 11.3 mm in TAP-lap and 41.8 ± 16.2 mm in Control (p = 0.001). 24 h after surgery was 16.6 ± 11.4 mm in TAP-lap and 35.4 ± 12.7 mm in Control (p = 0.001). Morphine rescues were necessary in 14.2% in Control and 2.8% in TAP-lap (p = 0.035).
CONCLUSION
Laparoscopic-guided TAP block as part of a multimodal analgesia regimen can reduce postoperative pain and opioid consumption, without increasing operative time.",2020,"Morphine rescues were necessary in 14.2% in Control and 2.8% in TAP-lap (p = 0.035).
","['One hundred and forty patients were included, 70 in each group', 'patients undergoing bariatric surgery', 'one-anastomosis gastric bypass', 'patients undergoing one-anastomosis gastric bypass surgery']","['postoperative laparoscopic-guided transversus abdominis plane (TAP) block', 'postoperative laparoscopic-guided TAP (TAP-lap) and patients not receiving TAP-lap (Control', 'Morphine', 'Laparoscopic-guided TAP block', 'postoperative laparoscopic-guided TAP block', 'ultrasonography', 'Bupivacaine']","['mean postoperative pain', 'mean operation time', 'Pain quantification', 'visual analogic scale (VAS', 'postoperative pain and opioid consumption']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",140.0,0.0787782,"Morphine rescues were necessary in 14.2% in Control and 2.8% in TAP-lap (p = 0.035).
","[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'Centre of Excellence for the Study and Treatment of Obesity and Diabetes, Valladolid, Spain. jruiztovar@gmail.com.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Gonzalez', 'Affiliation': 'Centre of Excellence for the Study and Treatment of Obesity and Diabetes, Valladolid, Spain.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Sarmiento', 'Affiliation': 'Centre of Excellence for the Study and Treatment of Obesity and Diabetes, Valladolid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Carbajo', 'Affiliation': 'Centre of Excellence for the Study and Treatment of Obesity and Diabetes, Valladolid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ortiz-de-Solorzano', 'Affiliation': 'Centre of Excellence for the Study and Treatment of Obesity and Diabetes, Valladolid, Spain.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Castro', 'Affiliation': 'Centre of Excellence for the Study and Treatment of Obesity and Diabetes, Valladolid, Spain.'}, {'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'Jimenez', 'Affiliation': 'Centre of Excellence for the Study and Treatment of Obesity and Diabetes, Valladolid, Spain.'}, {'ForeName': 'Lorea', 'Initials': 'L', 'LastName': 'Zubiaga', 'Affiliation': 'Centre of Excellence for the Study and Treatment of Obesity and Diabetes, Valladolid, Spain.'}]",Surgical endoscopy,['10.1007/s00464-019-07341-5']
530,31932939,Investigating the effects of drainage by hemovac drain on shoulder pain after female laparoscopic surgery and comparison with deep breathing technique: a randomized clinical trial study.,"BACKGROUND
The incidence of shoulder pain following laparoscopic surgery has been reported to be high. This study was designed to investigate the effect of Hemovac drain on postoperative pain of women after laparoscopic surgery, dose of postoperative drug, duration of hospitalization as well as comparison with deep breathing technique.
METHODS
In this clinical trial, one hundred and fourteen female patients treated by laparoscopy were randomly assigned to three groups of 38 patients. In our study group, the Hemovac drain was implemented from the secondary trocar site with a closed system. In the deep breathing group, the patient was asked to breathe slowly and deeply three time per hour at full vigilance after surgery. In the non-drain group, laparoscopic surgery was done routinely. The severity of abdominal and shoulder pain was measured with a visual scale of pain at 3, 6, 12, and 24 h after surgery.
RESULTS
There were no significant differences in age, type of surgery, duration of hospitalization, postoperative nausea and vomiting between the groups after surgery. The severity of shoulder pain was significant between groups 3, 6, 12, and 24 h after surgery (p < 0.001). Consumption of diclofenac after operation was higher in the control group (p < 0.001). The pain level of laparoscopic surgery was not different between the three groups within the first 24 h after surgery (p = 0.841).
CONCLUSIONS
The use of Hemovac drain in female laparoscopic surgery is beneficial for reducing the subsequent shoulder pain. Further studies are recommended to investigate the effects of deep breathing as a non-pharmacological and safe method in other laparoscopic areas.",2020,"There were no significant differences in age, type of surgery, duration of hospitalization, postoperative nausea and vomiting between the groups after surgery.","['one hundred and fourteen female patients treated by laparoscopy were randomly assigned to three groups of 38 patients', 'shoulder pain after female']","['diclofenac', 'drainage by hemovac drain', 'laparoscopic surgery and comparison with deep breathing technique', 'laparoscopic surgery', 'Hemovac drain']","['severity of shoulder pain', 'postoperative pain', 'severity of abdominal and shoulder pain', 'visual scale of pain', 'pain level of laparoscopic surgery', 'age, type of surgery, duration of hospitalization, postoperative nausea and vomiting']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C1328799', 'cui_str': 'Deep breathing (finding)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0520909', 'cui_str': 'PONV'}]",114.0,0.104382,"There were no significant differences in age, type of surgery, duration of hospitalization, postoperative nausea and vomiting between the groups after surgery.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Hosseinzadeh', 'Affiliation': 'Department of Anesthesiology and Operative Room, Mazandaran University of Medical Sciences, Allied medical sciences, Sari, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Nasiri', 'Affiliation': 'Department of Anesthesiology, Faculty of Allied Medical Sciences, Traditional and Complementary Medicine Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Khazar Street, 48471-16548, Sari, Iran. rezanf2002@yahoo.com.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Behroozi', 'Affiliation': 'Department of Obstetrics Surgery and Infertility, Reproductive Health Research Center, Urmia University of Medical Sciences, Urmia, Iran.'}]",Surgical endoscopy,['10.1007/s00464-019-07339-z']
531,31924365,Assessment of preoperative noninvasive ventilation before lung cancer surgery: The preOVNI randomized controlled study.,"OBJECTIVES
The preOVNI study was a randomized, controlled, open-label study that investigated whether preoperative noninvasive ventilation (NIV) could reduce postoperative complications after lung cancer surgery.
METHODS
Adult patients with planned lung cancer resection and with at least 1 cardiac or respiratory comorbidity were included and randomly assigned to preoperative NIV (at least 7 days and 4 h/day) or no NIV. The primary endpoint was the rate of postoperative protocol-defined complications.
RESULTS
Three hundred patients were included. In the NIV group, the median NIV duration was 8 days. No difference of postoperative complication rates was evidenced: 42.6% in NIV group and 44.8% in no-NIV group (P = .75). The rate of pneumonia was greater in no-NIV group compared with the NIV group, but statistical significance was not achieved (28.0 vs 37.7%, respectively; P = .08). The type of surgery (open or minimally invasive) did not impact these results after multivariable analysis.
CONCLUSIONS
No benefit was evidenced for preoperative NIV before lung cancer surgery. Further studies should determine the optimal perioperative management to decrease the rate of postoperative complications.",2020,"The rate of pneumonia was greater in no-NIV group compared with the NIV group, but statistical significance was not achieved (28.0 vs 37.7%, respectively; P = .08).","['before lung cancer surgery', 'Three hundred patients were included', 'Adult patients with planned lung cancer resection and with at least 1 cardiac or respiratory comorbidity', 'after lung cancer surgery']","['preoperative noninvasive ventilation', 'preoperative noninvasive ventilation (NIV']","['rate of postoperative protocol-defined complications', 'postoperative complication rates', 'postoperative complications', 'rate of pneumonia', 'median NIV duration']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",300.0,0.134838,"The rate of pneumonia was greater in no-NIV group compared with the NIV group, but statistical significance was not achieved (28.0 vs 37.7%, respectively; P = .08).","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Paleiron', 'Affiliation': 'Respiratory Disease Unit, HIA Sainte Anne, Toulon, France; Département de médecine interne et pneumologie, GETBO EA3878 CIC INSERM 1412, CHU Cavale Blanche, Brest, France. Electronic address: nicolas.paleiron@intradef.gouv.fr.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Grassin', 'Affiliation': 'Respiratory Disease Unit, HIA Clermont Tonnerre, Brest, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lancelin', 'Affiliation': 'Thoracic Surgery Unit, Clinique du Grand Large, Brest, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Tromeur', 'Affiliation': 'Département de médecine interne et pneumologie, GETBO EA3878 CIC INSERM 1412, CHU Cavale Blanche, Brest, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Margery', 'Affiliation': 'Respiratory Disease Unit, HIA Percy, Clamart, France.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Natale', 'Affiliation': 'Respiratory Disease Unit, HIA Sainte Anne, Toulon, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Couturaud', 'Affiliation': 'Département de médecine interne et pneumologie, GETBO EA3878 CIC INSERM 1412, CHU Cavale Blanche, Brest, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.09.193']
532,31953730,Use of prefrontal cortex activity as a measure of learning curve in surgical novices: results of a single blind randomised controlled trial.,"BACKGROUND
Neurobiological feedback in surgical training could translate to better educational outcomes such as measures of learning curve. This work examined the variation in brain activation of medical students when performing laparoscopic tasks before and after a training workshop, using functional near-infrared spectroscopy (fNIRS).
METHODS AND PROCEDURES
This single blind randomised controlled trial examined the prefrontal cortex activity (PFCA) differences in two groups of novice medical students during the acquisition of four laparoscopic tasks. Both groups were shown a basic tutorial video, with the ""Trained-group"" receiving an additional standardised one-to-one training on the tasks. The PFCA was measured pre- and post-intervention using a portable fNIRS device and reported as mean total oxygenated hemoglobin (HbOµm). Primary outcome of the study is the difference in HbOµm between post- and pre-intervention readings for each of the four laparoscopic tasks. The pre- and post-intervention laparoscopic tasks were recorded and assessed by two blinded individual assessors for objective scores of the performance.
RESULTS
16 Trained and 16 Untrained, right-handed medical students with an equal sex distribution and comparable age distribution were recruited. Trained group had an attenuated left PFCA in the ""Precision cutting"" (p = 0.007) task compared to the Untrained group. Subgroup analysis by sex revealed attenuation in left PFCA in Trained females compared to Untrained females across two laparoscopic tasks: ""Peg transfer"" (p = 0.005) and ""Precision cutting"" (p = 0.003). No significant PFCA attenuation was found in male students who underwent training compared to Untrained males.
CONCLUSION
A standardised laparoscopic training workshop promoted greater PFCA attenuation in female medical students compared to males. This suggests that female and male students respond differently to the same instructional approach. Implications include a greater focus on one-to-one surgical training for female students and use of PFCA attenuation as a form of neurobiological feedback in surgical training.",2020,"Subgroup analysis by sex revealed attenuation in left PFCA in Trained females compared to Untrained females across two laparoscopic tasks: ""Peg transfer"" (p = 0.005) and ""Precision cutting"" (p = 0.003).","['female students', 'surgical novices', '16 Trained and 16 Untrained, right-handed medical students with an equal sex distribution and comparable age distribution were recruited', 'male students', 'two groups of novice medical students during the acquisition of four laparoscopic tasks', 'female medical students', 'female and male students']","['Trained-group"" receiving an additional standardised one-to-one training on the tasks', 'laparoscopic training workshop']","['PFCA attenuation', 'HbOµm between post- and pre-intervention readings', 'mean total oxygenated hemoglobin (HbOµm']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0036878', 'cui_str': 'Sex Distribution'}, {'cui': 'C0001782', 'cui_str': 'Age Distribution'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",16.0,0.0345919,"Subgroup analysis by sex revealed attenuation in left PFCA in Trained females compared to Untrained females across two laparoscopic tasks: ""Peg transfer"" (p = 0.005) and ""Precision cutting"" (p = 0.003).","[{'ForeName': 'Howard C H', 'Initials': 'HCH', 'LastName': 'Khoe', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore. howardkhoe@gmail.com.'}, {'ForeName': 'Jun Wei', 'Initials': 'JW', 'LastName': 'Low', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Wijerathne', 'Affiliation': 'Minimally Invasive Surgery Centre, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Lui Su', 'Initials': 'LS', 'LastName': 'Ann', 'Affiliation': 'Minimally Invasive Surgery Centre, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Salgaonkar', 'Affiliation': 'Minimally Invasive Surgery Centre, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Lomanto', 'Affiliation': 'Minimally Invasive Surgery Centre, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'JongKwan', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'OBELAB, Inc, Seoul, South Korea.'}, {'ForeName': 'JiYeong', 'Initials': 'J', 'LastName': 'Baek', 'Affiliation': 'OBELAB, Inc, Seoul, South Korea.'}, {'ForeName': 'Wilson W', 'Initials': 'WW', 'LastName': 'Tam', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Ho', 'Initials': 'H', 'LastName': 'Pei', 'Affiliation': 'University Surgical Cluster, Department of Cardio-Thoracic & Vascular Surgery, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Roger C M', 'Initials': 'RCM', 'LastName': 'Ho', 'Affiliation': 'Institute for Health Innovation & Technology (iHealthtech), National University of Singapore (NUS), Singapore, 117599, Singapore.'}]",Surgical endoscopy,['10.1007/s00464-019-07331-7']
533,31523851,Public health nurse delivered group cognitive behavioral therapy (CBT) for postpartum depression: A pilot study.,"OBJECTIVES
Although postpartum depression (PPD) affects 1 in 5 women, just 15% receive treatment. Cognitive Behavioural Therapy (CBT) is a first-line treatment for PPD. The objective of this pilot study was to determine the feasibility and acceptability of public health nurse (PHN)-delivered group CBT for PPD and to determine preliminary estimates of effect.
DESIGN
A pre-posttest design was used. Participants provided data before and after the CBT groups.
SAMPLE
Seven women who were over the age of 18 and had given birth in the past year participated.
MEASUREMENTS
Feasibility and acceptability focused on PHN training, recruitment, retention, and adherence to the intervention. Participants provided data on depression, worry, health care utilization and mother-infant relations. Women and their partners reported on infant temperament.
INTERVENTION
Participants attended a 9-week CBT group delivered by two PHNs.
RESULTS
The PHN training, CBT intervention and our study protocol were found to be feasible and acceptable to participants. Reductions were seen in depression and worry. The number of health care visits decreased; mother-infant relations improved.
CONCLUSIONS
These findings highlight the feasibility of PHN-delivered group CBT for PPD and suggest that it could reduce the burden of PPD on women and their children.",2020,Reductions were seen in depression and worry.,"['SAMPLE\n\n\nSeven women who were over the age of 18 and had given birth in the past year participated', 'postpartum depression']","['Public health nurse delivered group cognitive behavioral therapy (CBT', 'Cognitive Behavioural Therapy (CBT', 'public health nurse (PHN)-delivered group CBT', 'CBT']","['number of health care visits decreased; mother-infant relations improved', 'Feasibility and acceptability focused on PHN training, recruitment, retention, and adherence to the intervention', 'depression, worry, health care utilization and mother-infant relations', 'burden of PPD']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}]","[{'cui': 'C0034022', 'cui_str': 'Public Health Nurses'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C3658199', 'cui_str': 'Mother-Infant Relations'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}]",,0.0335872,Reductions were seen in depression and worry.,"[{'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Van Lieshout', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Layton', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Feller', 'Affiliation': 'Public Health, Regional Municipality of Niagara, Thorold, Ontario, Canada.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ferro', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Biscaro', 'Affiliation': 'Family Health Division, Niagara Region Public Health and Emergency Services, Thorold, Ontario, Canada.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Bieling', 'Affiliation': ""Department of Psychiatry and Behavioural Neurosciences, McMaster University, Mental Health and Addictions Services, St. Joseph's Hospital, Hamilton, Ontario, Canada.""}]","Public health nursing (Boston, Mass.)",['10.1111/phn.12664']
534,31928890,Peripheral intravenous catheter needleless connector decontamination study-Randomized controlled trial.,"BACKGROUND
Needleless connectors (NCs) were introduced to reduce health care work needlestick injuries (NSIs). If not decontaminated prior to use, NCs can be a portal for patient blood stream infections. The optimal disinfectant, and its application duration, for NC decontamination has not been empirically established.
METHODS
Factorial design randomized controlled trial comparing 70% isopropyl alcohol (IPA) and 2% chlorhexidine gluconate (CHG) in 70% IPA for 5, 10, or 15 seconds, in adult medical patients with peripheral intravenous catheters.
RESULTS
At baseline, 153 of 300 NCs (51%) grew microorganisms commonly found on the skin. Decontamination was successful in 150/153 (98%). There was no significant difference in decontamination between 70% IPA or 2% CHG in 70% IPA (P = .62), or decontamination for 5, 10, or 15 seconds (P = .21).
CONCLUSIONS
There was no difference in the effectiveness of 70% IPA and 2% CHG in 70% IPA for NC decontamination for peripheral intravenous catheters in the clinical environment. Successful decontamination was not different for applications of 5, 10, and 15 seconds; 15 seconds did not always remove all microorganisms. Factors such as cost, feasibility of compliance, and low risk of allergy support 5 seconds decontamination with 70% IPA as an acceptable approach.",2020,"Successful decontamination was not different for applications of 5, 10, and 15 seconds; 15 seconds did not always remove all microorganisms.","['70% IPA for 5, 10, or 15 seconds, in adult medical patients with peripheral intravenous catheters']",['isopropyl alcohol (IPA) and 2% chlorhexidine gluconate (CHG'],['decontamination'],"[{'cui': 'C0614109', 'cui_str': 'I(S)pA(S)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter, device (physical object)'}]","[{'cui': 'C0022237', 'cui_str': 'rubbing alcohol'}, {'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}, {'cui': 'C1527601', 'cui_str': '(alphaMe)Chg'}]","[{'cui': 'C0011121', 'cui_str': 'Decontamination'}]",,0.102911,"Successful decontamination was not different for applications of 5, 10, and 15 seconds; 15 seconds did not always remove all microorganisms.","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Slater', 'Affiliation': 'Princess Alexandra Hospital, Brisbane, Australia; School of Nursing and Midwifery, Griffith University, Brisbane, Australia. Electronic address: karen.slater@health.qld.gov.au.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Cooke', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Brisbane, Australia; Alliance for Vascular Access Teaching & Research (AVATAR) Group, Menzies Health Institute Queensland, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Fullerton', 'Affiliation': 'Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Whitby', 'Affiliation': 'Greenslopes Clinical School, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Jennine', 'Initials': 'J', 'LastName': 'Hay', 'Affiliation': 'Pathology Queensland-Health Support Queensland, Brisbane, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Lingard', 'Affiliation': 'Pathology Queensland-Health Support Queensland, Brisbane, Australia.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Douglas', 'Affiliation': 'Pathology Queensland-Health Support Queensland, Brisbane, Australia.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Rickard', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Brisbane, Australia; Alliance for Vascular Access Teaching & Research (AVATAR) Group, Menzies Health Institute Queensland, Griffith University, Brisbane, Australia.'}]",American journal of infection control,['10.1016/j.ajic.2019.11.030']
535,31630566,Community-Partnered Evaluation of the Aging Mastery Program in Los Angeles Area Senior Centers.,"Background. The National Council on Aging's Aging Mastery Program (AMP) aims to help older adults implement health behavior and lifestyle changes to promote healthy aging and social engagement. The purpose of the present community-partnered evaluation was to test the effectiveness of AMP implementation in Los Angeles County to improve participants' quality of life, global physical and mental health, and patient activation. Method. A modified randomized wait-list controlled trial design was used to examine experimental, quasi-experimental, and dose-response evidence in five senior centers. Participants completed questionnaires at baseline and after the 10-week intervention, self-reporting their overall quality of life, physical health, mental health, and patient activation. Results. Experimental, intention-to-treat analyses found AMP assignment did not affect any measured outcomes ( n = 71). Quasi-experimental, ""as treated"" analyses ( n = 106) controlling for study site and sociodemographic characteristics indicated that participants who attended AMP reported more positive changes in global mental health than the control group. Attending AMP was not associated with changes in quality of life, physical health, or patient activation. Dose-response analyses among AMP participants who attended at least one class ( n = 75) found that attending more classes was not significantly associated with greater improvements in mental health. Conclusions. Experimental, intention-to-treat analyses did not support effectiveness of AMP on quality of life, physical or mental health, or patient activation; quasi-experimental analyses found attending AMP was associated with improvements in mental health. Recruitment challenges and participants' nonadherence with condition assignment decreased our ability to detect effects. https://clinicaltrials.gov/ct2/show/NCT03342729?term=Aging+Mastery+Program&rank=1 .",2020,"Experimental, intention-to-treat analyses did not support effectiveness of AMP on quality of life, physical or mental health, or patient activation; quasi-experimental analyses found attending AMP was associated with improvements in mental health.","['five senior centers', 'Los Angeles Area Senior Centers']",['Mastery Program (AMP'],"['quality of life, physical health, or patient activation', 'global mental health', 'self-reporting their overall quality of life, physical health, mental health, and patient activation', 'quality of life, physical or mental health, or patient activation', ""participants' quality of life, global physical and mental health, and patient activation"", 'mental health']","[{'cui': 'C3658240', 'cui_str': 'Centers for the Aged'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}]","[{'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",5.0,0.0743711,"Experimental, intention-to-treat analyses did not support effectiveness of AMP on quality of life, physical or mental health, or patient activation; quasi-experimental analyses found attending AMP was associated with improvements in mental health.","[{'ForeName': 'Lourdes R', 'Initials': 'LR', 'LastName': 'Guerrero', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Josephine A', 'Initials': 'JA', 'LastName': 'Menkin', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Carmen A', 'Initials': 'CA', 'LastName': 'Carrillo', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Carmen E', 'Initials': 'CE', 'LastName': 'Reyes', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Trejo', 'Affiliation': 'City of Los Angeles Department of Aging, Los Angeles, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Banks', 'Affiliation': 'Aging and Community Services, Los Angeles, CA, USA.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sarkisian', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119882992']
536,29699408,A qualitative analysis of trainer/coach experiences of changing care home practice in the Well-being and Health in Dementia randomised control trial.,,2020,"The third theme, 'being an agent for change' contained three subthemes: effective training methods, creating opportunities for Dementia Champions to reflect and therapists' perceived rewards of their role.","['residents living with dementia', ""Twelve participants explored their preparedness for and experiences of their role as 'Well-being and Health for people with Dementia therapists""]",['dementia trainer/coaches and supervisors who had worked on Well-being and Health'],[],"[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0403172', 'cui_str': 'Supervisor (occupation)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],12.0,0.0550911,"The third theme, 'being an agent for change' contained three subthemes: effective training methods, creating opportunities for Dementia Champions to reflect and therapists' perceived rewards of their role.","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Fossey', 'Affiliation': ''}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Garrod', 'Affiliation': 'Oxford Health NHS Foundation Trust, UK.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'Guzman', 'Affiliation': 'University of Edinburgh, UK.'}, {'ForeName': 'Ingelin', 'Initials': 'I', 'LastName': 'Testad', 'Affiliation': 'University of Exeter, UK.'}]","Dementia (London, England)",['10.1177/1471301218772178']
537,31132893,Evaluation of Neurofeedback for Posttraumatic Stress Disorder Related to Refugee Experiences Using Self-Report and Cognitive ERP Measures.,"Background . Neurofeedback holds promise as an intervention for the psychophysiological dysfunction found in posttraumatic stress disorder (PTSD). Few empirical studies have assessed the efficacy of neurofeedback for PTSD, and none in individuals with refugee trauma. A proposed mechanism for neurofeedback efficacy in PTSD is through remediating deficits in cognitive control. We assessed pre- and postchanges in symptoms and neurocognitive functioning of refugee clients participating in a neurofeedback intervention for PTSD. Methods . Clinical data for 13 adult refugees with chronic PTSD who participated in neurofeedback combined with trauma counseling (NFT) was compared with 13 adult refugees placed on a waitlist to receive neurofeedback. Waitlist clients continued to receive trauma counseling alone (TC). NFT was additionally assessed pre- and posttherapy for changes in event-related potentials (ERPs) and behavioral indices of cognitive control using a visual continuous performance task (VCPT). Comparison VCPT data from healthy controls (HC) was available from the Human Brain Index database. Results . Posttherapy, NFT had significantly lower symptoms of trauma, anxiety, and depression compared with TC. NFT demonstrated an increased P3 amplitude and improved behavioral performance suggesting a normalization of cognitive control. Conclusions . These preliminary observations are consistent with a possible benefit of neurofeedback for remediating PTSD. This may be achieved at least partially by an improvement in cognitive control. Further confirmation of the effectiveness of the treatment now requires a randomized controlled trial that considers issues such as placebo response, nonspecific therapist effects, and duration of treatment.",2020,"RESULTS
Posttherapy, NFT had significantly lower symptoms of trauma, anxiety, and depression compared with TC.","['refugee clients participating in a neurofeedback intervention for PTSD', 'individuals with refugee trauma', '13 adult refugees with chronic PTSD who participated in', 'healthy controls (HC']","['trauma counseling alone (TC', 'neurofeedback combined with trauma counseling (NFT', '13 adult refugees placed on a waitlist to receive neurofeedback', 'NFT']","['P3 amplitude and improved behavioral performance', 'pre- and posttherapy for changes in event-related potentials (ERPs) and behavioral indices of cognitive control using a visual continuous performance task (VCPT', 'symptoms of trauma, anxiety, and depression']","[{'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3697414', 'cui_str': 'Counseling for trauma (procedure)'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0282171', 'cui_str': 'Potentials, Event-Related'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C4329232', 'cui_str': 'Continuous Performance Task'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",13.0,0.0482821,"RESULTS
Posttherapy, NFT had significantly lower symptoms of trauma, anxiety, and depression compared with TC.","[{'ForeName': 'Mirjana', 'Initials': 'M', 'LastName': 'Askovic', 'Affiliation': 'New South Wales Service for the Treatment and Rehabilitation of Torture and Trauma Survivors (STARTTS), Carramar, New South Wales, Australia.'}, {'ForeName': 'Anna J', 'Initials': 'AJ', 'LastName': 'Watters', 'Affiliation': 'New South Wales Service for the Treatment and Rehabilitation of Torture and Trauma Survivors (STARTTS), Carramar, New South Wales, Australia.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Coello', 'Affiliation': 'New South Wales Service for the Treatment and Rehabilitation of Torture and Trauma Survivors (STARTTS), Carramar, New South Wales, Australia.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Aroche', 'Affiliation': 'New South Wales Service for the Treatment and Rehabilitation of Torture and Trauma Survivors (STARTTS), Carramar, New South Wales, Australia.'}, {'ForeName': 'Anthony W F', 'Initials': 'AWF', 'LastName': 'Harris', 'Affiliation': 'Brain Dynamics Centre, The Westmead Institute for Medical Research and Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jury', 'Initials': 'J', 'LastName': 'Kropotov', 'Affiliation': 'N.P. Bechtereva Institute of the Human Brain of the Russian Academy of Sciences, Saint-Petersburg, Russia.'}]",Clinical EEG and neuroscience,['10.1177/1550059419849170']
538,31769161,Clinical outcomes of complex lesions treated with an abluminal groove-filled biodegradable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent.,"BACKGROUND
The Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel biodegradable polymer sirolimus-eluting coronary stent has been evaluated in the randomized TARGET I trial in which low-risk patients were enrolled with strict eligibility criteria. Recently, the TARGET All Comers study has shown similar results of the Firehawk compared to the XIENCE stent (Abbott Vascular, Santa Clara). However, clinical outcomes in high-risk patients are unclear.
METHODS
The TARGET All Comer study was a randomized trial that assigned patients to either Firehawk or XIENCE implantation. This TARGET AC subanalysis sought to evaluate the 2 year clinical outcomes of patients according to two risk groups; patients meeting all inclusion criteria and no exclusion criteria of the TARGET I trial were classified as ""low-risk,"" while their counterparts were classified as ""high-risk."" The primary endpoint was target lesion failure.
RESULTS
A total of 1,585 patients were included, of which 1,334 (84%) were classified as high-risk. At 2 years, the high-risk group had a significantly higher rate of TLF than the low-risk group (9.5% vs. 3.6%, p = .003), mainly driven by increased target vessel myocardial infarction (6.3% vs. 2.4%, p = .02). The Firehawk and XIENCE had no significant differences in TLF among both low-risk (3.1% vs. 4.2%, p = .66) and high-risk (9.9% vs. 9.1%, p = .57) patients.
CONCLUSIONS
High-risk patients had worse clinical outcomes at 2 years in the TARGET All Comer study. Outcomes with the Firehawk were similar to the XIENCE stent among both low-risk and high-risk patients at 2 years.",2020,"At 2 years, the high-risk group had a significantly higher rate of TLF than the low-risk group (9.5% vs. 3.6%, p = .003), mainly driven by increased target vessel myocardial infarction (6.3% vs. 2.4%, p = .02).","['A total of 1,585 patients were included, of which 1,334 (84%) were classified as high-risk', 'low-risk patients were enrolled with strict eligibility criteria', 'patients according to two risk groups; patients meeting all inclusion criteria and no exclusion criteria of the TARGET']","['complex lesions treated with an abluminal groove-filled biodegradable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent', 'Firehawk or XIENCE implantation']","['target vessel myocardial infarction', 'target lesion failure', 'high-risk', 'rate of TLF', 'TLF']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]",1585.0,0.0843211,"At 2 years, the high-risk group had a significantly higher rate of TLF than the low-risk group (9.5% vs. 3.6%, p = .003), mainly driven by increased target vessel myocardial infarction (6.3% vs. 2.4%, p = .02).","[{'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Baumbach', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': 'The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway and Saolta University Healthcare Group, University College Hospital Galway, Galway, Ireland.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Fu Wai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbaek', 'Affiliation': 'Department of Cardiology, Roskilde University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Shanghai MicroPort Medical (Group) Co., Ltd., Shanghai, China.'}, {'ForeName': 'Marie-Angèle', 'Initials': 'MA', 'LastName': 'Morel', 'Affiliation': 'Cardialysis, Rotterdam, The Netherlands.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'Department of Cardiology, University Hospital of Wales, Heath Park, Cardiff, UK.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Schächinger', 'Affiliation': 'Medizinische Klinik I, Herz-Thorax Zentrum, Klinikum Fulda, Fulda, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Lansky', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28609']
539,30969032,Combined nestorone-testosterone gel suppresses serum gonadotropins to concentrations associated with effective hormonal contraception in men.,"BACKGROUND
Novel male-based contraceptives are needed to broaden family planning choices. A progestin, Nestorone ® (Nes) gel, plus a testosterone (T) gel suppresses sperm concentrations to levels associated with effective contraception in normal men. However, administration of two gels on different parts of the body daily is impractical.
OBJECTIVE
Compare the effectiveness of daily application of a single, combined 8.3 mg Nes-62.5 mg T gel (Nes-T) vs. 62.7 mg T gel to suppress serum FSH and LH concentrations to ≤1.0 IU/L (a threshold associated with suppression of sperm concentrations to ≤1 million and effective contraception) and to compare the pharmacokinetics of serum Nes and T concentrations between the gel groups.
DESIGN
We conducted a 28-day, double-blind, controlled trial of 44 healthy men randomized to daily Nes-T or T gel with measurement of hormones at baseline, treatment, and recovery and during 24-h pharmacokinetic studies on days 1 and 28 of treatment.
RESULTS
Of the subjects who met pre-defined inclusion criteria, 84% of the Nes-T group suppressed serum gonadotropin concentrations to ≤1.0 IU/L at days 21-28 vs. 16.7% in the T group (p < 0.001). On day 1, Nes concentrations rose significantly above baseline by 2 h and continued to rise up to 24 h after Nes-T gel application. Nes concentrations were not detectable in the T group. Serum total T concentrations rose and were significantly higher in the T gel group compared to the Nes-T group at 24 h on day 1 and days 11, 14, and 21 (p < 0.01). There were no serious adverse events in either group. About 80% of the subjects reported satisfaction with both gels.
CONCLUSION
Daily Nes-T gel effectively and safely suppresses serum gonadotropins and is acceptable to most men. It should be studied further in efficacy trials of hormonal male contraception.",2019,"Serum total T concentrations rose and were significantly higher in the T gel group compared to the Nes-T group at 24 h on day 1 and days 11, 14, and 21 (p < 0.01).","['men', '44 healthy men randomized to', 'normal men']","['progestin, Nestorone ® (Nes) gel, plus a testosterone (T) gel', 'Combined nestorone-testosterone gel', 'daily Nes-T or T gel']","['Nes and T concentrations', 'serum FSH and LH concentrations', 'Nes concentrations', 'Serum total T concentrations', 'serum gonadotropin concentrations', 'serious adverse events']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0283986', 'cui_str': 'Nestorone'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",44.0,0.0605677,"Serum total T concentrations rose and were significantly higher in the T gel group compared to the Nes-T group at 24 h on day 1 and days 11, 14, and 21 (p < 0.01).","[{'ForeName': 'B D', 'Initials': 'BD', 'LastName': 'Anawalt', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Roth', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ceponis', 'Affiliation': 'Institute of Endocrinology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Surampudi', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Amory', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.'}, {'ForeName': 'P Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dart', 'Affiliation': 'Health Decisions, Durham, NC, USA.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Bremner', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sitruk-Ware', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Blithe', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Page', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.'}]",Andrology,['10.1111/andr.12603']
540,31232840,A Comparison of Three Dressing Methods for Pilonidal Sinus Surgery Wound Healing.,"OBJECTIVE
To evaluate the effect of different dressing methods on the wound healing process after pilonidal sinus surgery.
METHODS
In this clinical trial, 60 patients undergoing pilonidal sinus surgery were randomly assigned to one of three groups. In the first group, hydrogel or alginate and hydrocolloid compounds were used as a standard occlusive dressing method. A modified dressing method was used for the second group, in which transparent hydrocolloid films were replaced by Vaseline gauze. The third group was treated using gauze swabs soaked in normal saline. The length and depth of the studied wounds were recorded once a week for a month. During dressing changes, patient pain was recorded using an 11-point numeric rating scale. The collected data were analyzed by descriptive and inferential statistical methods.
RESULTS
There was a significant reduction in wound length after 2 weeks in all three groups (P < .05), and the pain experienced by the first and second groups was significantly lower than the third group. However, the modified method used for the second group was associated with a lower cost.
CONCLUSIONS
Considering the beneficial results of using modern dressings for wound healing and reducing the severity of associated pain, providers may want to consider using modified wound dressings after pilonidal sinus surgery. Study authors recommend that providers receive training on how to use these products.",2019,"There was a significant reduction in wound length after 2 weeks in all three groups (P < .05), and the pain experienced by the first and second groups was significantly lower than the third group.","['60 patients undergoing pilonidal sinus surgery', 'Pilonidal Sinus Surgery Wound Healing']","['gauze swabs soaked in normal saline', 'hydrogel or alginate and hydrocolloid', 'Vaseline gauze']","['patient pain', 'wound healing process', 'length and depth of the studied wounds', '11-point numeric rating scale', 'wound length', 'pain experienced']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031925', 'cui_str': 'Pilonidal Cyst'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]","[{'cui': 'C0590323', 'cui_str': 'Gauzes (physical object)'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0102137', 'cui_str': 'alginate'}, {'cui': 'C0020266', 'cui_str': 'Hydrocolloids'}, {'cui': 'C0728774', 'cui_str': 'Vaseline'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0222045'}]",60.0,0.0150848,"There was a significant reduction in wound length after 2 weeks in all three groups (P < .05), and the pain experienced by the first and second groups was significantly lower than the third group.","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Sadati', 'Affiliation': ""At the Alborz University of Medical Sciences, in Karaj, Iran, Leila Sadati, MScN, BScN, is a faculty member, Paramedic School; Robab Froozesh, MScN, BScN, is a Neonatal Intensive Care Nurse, Paramedic School; Zahra Nouri Khaneghah, MSc, is a faculty member, Paramedic School; and Seyed Ahmad Elahi, MD, is faculty member, Department of General Surgery, School of Medicine. At the Iran University of Medical Sciences in Tehran, Iran, Alireza Beyrami, MSc, and Mohammad Faryab Asl, MSc, are Operating Room Technologists, Faculty of Allied Medicine. Tannaz Salehi, MSc, is a Master's Student of Medical Physiology, Faculty of Medicine, Tehran University of Medical Sciences.""}, {'ForeName': 'Robab', 'Initials': 'R', 'LastName': 'Froozesh', 'Affiliation': ''}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Beyrami', 'Affiliation': ''}, {'ForeName': 'Zahra Nouri', 'Initials': 'ZN', 'LastName': 'Khaneghah', 'Affiliation': ''}, {'ForeName': 'Seyed Ahmad', 'Initials': 'SA', 'LastName': 'Elahi', 'Affiliation': ''}, {'ForeName': 'Mohammad Faryab', 'Initials': 'MF', 'LastName': 'Asl', 'Affiliation': ''}, {'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Salehi', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000558268.59745.d2']
541,31912491,"Effect of footplate neuromuscular electrical stimulation on functional and quality-of-life parameters in patients with peripheral artery disease: pilot, and subsequent randomized clinical trial.","BACKGROUND
Supervised exercise programmes for intermittent claudication have poor access and limited compliance. Neuromuscular electrical stimulation (NMES) may be an effective alternative. A proof-of-concept study and RCT were conducted.
METHODS
In study 1, eligible patients underwent baseline assessment; treadmill testing for initial (ICD) and maximum (MCD) claudication distance; EuroQoL Five Dimensions five-level instrument (EQ-5D-5L™) and Intermittent Claudication Questionnaire (ICQ) assessment; and measurement of ultrasound haemodynamics of the superficial femoral artery. After familiarization with the NMES device, participants underwent a 30-min session of stimulation with concomitant recording of haemodynamic measures at 15 min, and after device cessation. Measurements were repeated after 6 weeks of daily use of NMES. In study 2, consecutive patients underwent baseline assessment before online randomization to a supervised exercise programme only, or adjunctive NMES treatment for 6 weeks, followed by repeat measurements.
RESULTS
Study 1 (20 patients) showed a significant improvement in MCD (46 per cent; P < 0·001) and ICD (71 per cent; P < 0·001). The RCT (42 patients) showed a significant adjunctive benefit of NMES in ICD (46 per cent; P = 0·014). Improvements were seen in the ICQ (9 points; P = 0·009) and EQ-5D-5L™ (P = 0·007) in study 1, and there was a significant adjunctive benefit of NMES on the ICQ score in patients who did supervised exercise (11·2 points; P = 0·031). Blood volume flow and time-adjusted mean velocity increased significantly with the device on (P < 0·050). Overall, NMES compliance exceeded 95 per cent.
CONCLUSION
Footplate NMES significantly improved walking distance in patients with intermittent claudication when used independently and also as an adjunct to supervised exercise. Registration number: trial 1, NCT02436200; trial 2, NCT02429310 (http://www.clinicaltrials.gov).",2020,"Improvements were seen in the ICQ (9 points; P = 0·009) and EQ-5D-5L™ (P = 0·007) in study 1, and there was a significant adjunctive benefit of NMES on the ICQ score in patients who did supervised exercise (11·2 points; P = 0·031).","['eligible patients underwent baseline assessment', 'patients with intermittent claudication', 'patients with peripheral artery disease']","['Neuromuscular electrical stimulation (NMES', 'supervised exercise programme only, or adjunctive NMES treatment', 'footplate neuromuscular electrical stimulation', 'NMES', 'Footplate NMES']","['walking distance', 'Blood volume flow and time-adjusted mean velocity', 'treadmill testing for initial (ICD) and maximum (MCD) claudication distance; EuroQoL Five Dimensions five-level instrument (EQ-5D-5L™) and Intermittent Claudication Questionnaire (ICQ) assessment; and measurement of ultrasound haemodynamics of the superficial femoral artery', 'MCD', 'Overall, NMES compliance', 'ICQ score', 'functional and quality-of-life parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021775', 'cui_str': 'Intermittent Claudication'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}]","[{'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0005850', 'cui_str': 'Blood Volume'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0087110', 'cui_str': 'Treadmill Test'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0429887', 'cui_str': 'Claudication distance (observable entity)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0021775', 'cui_str': 'Intermittent Claudication'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0447106', 'cui_str': 'Superficial femoral artery (body structure)'}, {'cui': 'C1636149', 'cui_str': 'Mcd'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.243268,"Improvements were seen in the ICQ (9 points; P = 0·009) and EQ-5D-5L™ (P = 0·007) in study 1, and there was a significant adjunctive benefit of NMES on the ICQ score in patients who did supervised exercise (11·2 points; P = 0·031).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Babber', 'Affiliation': 'Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ravikumar', 'Affiliation': 'Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Onida', 'Affiliation': 'Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'T R A', 'Initials': 'TRA', 'LastName': 'Lane', 'Affiliation': 'Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Davies', 'Affiliation': 'Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}]",The British journal of surgery,['10.1002/bjs.11398']
542,31099455,Effectiveness of a brief phone intervention to increase participation in a population-based colorectal cancer screening programme: a randomized controlled trial.,"AIM
Although colorectal cancer (CRC) screening reduces mortality and morbidity the uptake in target populations is suboptimal. The aim was to assess whether adding a brief phone intervention to the usual invitation process increases participation in a CRC screening programme based in Catalonia.
METHOD
This was a non-blinded prospective randomized control study of patients eligible for their first CRC screening test (immunochemical faecal occult blood test). Between March and December 2017, 512 invitees (age range 50-69 years) were randomized to receiving either a brief informative phone call prior to receiving the standard screening invitation (letter and informative brochure) or the standard screening invitation alone. The primary outcome was participation in the screening programme at 6 months.
RESULTS
In all, 492/512 patients (54.7% women; 45.3% men) could be analysed (239/256 intervention group; 253/256 control group). On an intention to treat basis, the intervention group (55% women; 45% men) saw an 11% increase in the participation rate (51.05% vs 40.32%, P = 0.017). The intervention was more effective in male patients (50.93% vs 33.91%, P = 0.01) and those patients aged between 50 and 54 years (54.32% vs 37.77%, P = 0.03). After adjusting for sex, age and geographic area, the benefit of the intervention remained statistically significant (adjusted OR 1.54, 95% CI 1.07-2.20).
CONCLUSION
Our data suggest that a brief, informative intervention by phone in addition to the usual invitation process is effective in increasing participation in a CRC screening programme. It may be a useful strategy to improve uptake in groups which are less likely to participate in CRC screening (clinicaltrials.gov NCT03082911).",2019,"The intervention was more effective in male patients (50.93% vs 33.91%, P = 0.01) and those patients aged between 50 and 54 years (54.32% vs 37.77%, P = 0.03).","['population-based colorectal cancer screening programme', '492/512 patients (54.7% women; 45.3% men', 'Between March and December 2017, 512 invitees (age range 50-69 years', 'patients eligible for their first CRC screening test (immunochemical faecal occult blood test']","['brief phone intervention', 'brief informative phone call prior to receiving the standard screening invitation (letter and informative brochure) or the standard screening invitation alone']","['participation in the screening programme at 6\xa0months', 'participation rate']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.0613802,"The intervention was more effective in male patients (50.93% vs 33.91%, P = 0.01) and those patients aged between 50 and 54 years (54.32% vs 37.77%, P = 0.03).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Selva', 'Affiliation': 'Clinical Epidemiology and Cancer Screening, Parc Taulí Hospital Universitari, Sabadell, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Torà', 'Affiliation': 'Clinical Epidemiology and Cancer Screening, Parc Taulí Hospital Universitari, Sabadell, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pascual', 'Affiliation': 'Clinical Epidemiology and Cancer Screening, Parc Taulí Hospital Universitari, Sabadell, Spain.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Espinàs', 'Affiliation': ""Catalan Cancer Plan, Catalan Health Government, Catalan Institute of Oncology, L'Hospitalet de Llobregat Barcelona, Spain.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Baré', 'Affiliation': 'Clinical Epidemiology and Cancer Screening, Parc Taulí Hospital Universitari, Sabadell, Spain.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.14707']
543,30614004,Enteral Docosahexaenoic Acid and Retinopathy of Prematurity: A Randomized Clinical Trial.,"BACKGROUND
Retinopathy of prematurity (ROP) is a disorder of the retina of low-birth-weight preterm infants that potentially leads to blindness. Docosahexaenoic acid (DHA), is protective in experimental models, but its administration as part of parenteral nutrition has shown inconsistent results. We test the effect of enteral DHA to prevent ROP and/or severity and to reduce hospital stay.
METHODS
This was a double-blind parallel clinical trial. Preterm infants (n = 110; 55 per group) with birth weight <1500 g but ≥1000 g were recruited in a neonatal intensive care unit. Infants were randomized to receive 75 mg of DHA/kg/d (DHA group) or high oleic sunflower oil (control group) for 14 days by enteral feeding. The effect of DHA was evaluated on any stage of ROP, severe ROP (stage ≥3) incidence, and hospital stay. Groups were compared with relative risk (RR) and 95% confidence interval (CI), Fisher's exact test, Student's t-test, or Mann-Whitney U-test, as appropriate. Logistic regression was applied to adjust for confounders.
RESULTS
There was no difference between the DHA and control groups in ROP risk (RR for DHA = 0.79; 95% CI, 0.49-1.27; P = 0.33). However, patients who received DHA showed lower risk for stage 3 ROP (RR for DHA = 0.66; 95% CI, 0.44-0.99; P = 0.03). After adjusting for confounders, this decreased risk remained significant (adjusted odds ratio = 0.10; 95% CI, 0.011-0.886; P = 0.04). Hospital stay was similar between groups.
CONCLUSION
Enteral DHA may reduce the incidence of stage 3 ROP.",2019,"There was no difference between the DHA and control groups in ROP risk (RR for DHA = 0.79; 95% CI, 0.49-1.27; P = 0.33).","['Preterm infants (n = 110; 55 per group) with birth weight', 'but ≥1000 g were recruited in a neonatal intensive care unit', 'and Retinopathy of Prematurity']","['enteral DHA', 'DHA', 'Enteral Docosahexaenoic Acid', 'DHA/kg/d (DHA group) or high oleic sunflower oil (control group', 'Docosahexaenoic acid (DHA']","['lower risk for stage 3 ROP', 'stage of ROP, severe ROP (stage ≥3) incidence, and hospital stay', 'ROP risk', 'Hospital stay']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}]","[{'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.437828,"There was no difference between the DHA and control groups in ROP risk (RR for DHA = 0.79; 95% CI, 0.49-1.27; P = 0.33).","[{'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Bernabe-García', 'Affiliation': 'Unidad de Investigación Médica en Nutrición, Hospital de Pediatría, Centro Médico Nacional, Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Villegas-Silva', 'Affiliation': 'Neonatología, Hospital Infantil de México Federico Gómez, México City, México.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Villavicencio-Torres', 'Affiliation': 'Oftalmología Pediátrica, General Hospital, Centro Médico Nacional La Raza, Instituto Mexicano del Seguro Social, Ciudad de México, México.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Maricela', 'Initials': 'M', 'LastName': 'Rodríguez-Cruz', 'Affiliation': 'Unidad de Investigación Médica en Nutrición, Hospital de Pediatría, Centro Médico Nacional, Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Maldonado-Hernández', 'Affiliation': 'Unidad de Investigación Médica en Nutrición, Hospital de Pediatría, Centro Médico Nacional, Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.'}, {'ForeName': 'Denisse', 'Initials': 'D', 'LastName': 'Macías-Loaiza', 'Affiliation': 'Unidad de Investigación Médica en Nutrición, Hospital de Pediatría, Centro Médico Nacional, Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.'}, {'ForeName': 'Mardia', 'Initials': 'M', 'LastName': 'López-Alarcón', 'Affiliation': 'Unidad de Investigación Médica en Nutrición, Hospital de Pediatría, Centro Médico Nacional, Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Inda-Icaza', 'Affiliation': 'Nutrición, Universidad Anáhuac México, Campus Norte, Huixquilucan, Estado de México, México.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Cruz-Reynoso', 'Affiliation': 'División de Pediatría, Hospital de Gineco-Obstetricia No.3, Centro Médico Nacional La Raza, Instituto Mexicano del Seguro Social, Ciudad de México, México.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1497']
544,30626911,"A phase 2, double-blind, placebo-controlled study of NSI-189 phosphate, a neurogenic compound, among outpatients with major depressive disorder.","NSI-189 is a novel neurogenic compound independent of monoamine reuptake pathways. This trial evaluated oral NSI-189 as monotherapy in major depressive disorder. To improve signal detection, the sequential-parallel comparison design (SPCD) was chosen. Two hundred and twenty subjects were randomized to NSI-189 40 mg daily, 80 mg daily, or placebo for 12 weeks. The primary outcome measure was the Montogmery Asberg Depression Rating Scale (MADRS). Secondary subject-rated measures included the Symptoms of Depression Questionnaire (SDQ), the Cognitive and Physical Functioning Scale (CPFQ), the patient-rated version of the Quick Inventory of Depressive Symptomatology Scale (QIDS-SR), and subtests from the CogScreen and Cogstate cognitive tests. MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively). However, the 40 mg dose showed greater overall reduction in SDQ (pooled mean difference -8.2; Cohen's d for Stages 1 and 2 = -0.11 and -0.64, p = 0.04), and CPFQ scores (pooled mean difference -1.9; Cohen's d for Stages 1 and 2 = -0.28 and -0.47, p = 0.03) versus placebo, as well as QIDS-SR scores in Stage 2 of SPCD (-2.5; Cohen's d Stages 1 and 2 = -0.03 and -0.68, p = 0.04). The 40 mg dose also showed advantages on some objective cognitive measures of the CogScreen (absolute Cohen's d ranged between 0.12 and 1.12 in favor of NSI-189, p values between 0.002 and 0.048 for those with overall significance), but not the Cogstate test. Both doses were well tolerated. These findings replicate those of phase 1b study, and warrant further exploration of the antidepressant and pro-cognitive effects of NSI-189.",2020,"MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively).","['major depressive disorder', 'Two hundred and twenty subjects were randomized to NSI-189 40', 'outpatients with major depressive disorder']","['NSI-189 phosphate', 'NSI-189', 'placebo']","['Montogmery Asberg Depression Rating Scale (MADRS', 'MADRS score reduction', 'Symptoms of Depression Questionnaire (SDQ), the Cognitive and Physical Functioning Scale (CPFQ), the patient-rated version of the Quick Inventory of Depressive Symptomatology Scale (QIDS-SR), and subtests from the CogScreen and Cogstate cognitive tests', 'QIDS-SR scores', 'tolerated', 'overall reduction in SDQ', 'objective cognitive measures of the CogScreen', 'CPFQ scores']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C4507670', 'cui_str': 'NSI-189'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C4507671', 'cui_str': 'NSI-189 phosphate'}, {'cui': 'C4507670', 'cui_str': 'NSI-189'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",220.0,0.16936,"MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively).","[{'ForeName': 'G I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA. gpapakostas@partners.org.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Johe', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hand', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Drouillard', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Russo', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kay', 'Affiliation': 'Cognitive Research Corp., Saint Petersburg, Florida, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kashambwa', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Martinson', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0334-8']
545,31276165,Treatment-Specific Composition of the Gut Microbiota Is Associated With Disease Remission in a Pediatric Crohn's Disease Cohort.,"BACKGROUND
The beneficial effects of antibiotics in Crohn's disease (CD) depend in part on the gut microbiota but are inadequately understood. We investigated the impact of metronidazole (MET) and metronidazole plus azithromycin (MET+AZ) on the microbiota in pediatric CD and the use of microbiota features as classifiers or predictors of disease remission.
METHODS
16S rRNA-based microbiota profiling was performed on stool samples from 67 patients in a multinational, randomized, controlled, longitudinal, 12-week trial of MET vs MET+AZ in children with mild to moderate CD. Profiles were analyzed together with disease activity, and then used to construct random forest models to classify remission or predict treatment response.
RESULTS
Both MET and MET+AZ significantly decreased diversity of the microbiota and caused large treatment-specific shifts in microbiota structure at week 4. Disease remission was associated with a treatment-specific microbiota configuration. Random forest models constructed from microbiota profiles before and during antibiotic treatment with metronidazole accurately classified disease remission in this treatment group (area under the curve [AUC], 0.879; 95% confidence interval, 0.683-0.9877; sensitivity, 0.7778; specificity, 1.000; P < 0.001). A random forest model trained on pre-antibiotic microbiota profiles predicted disease remission at week 4 with modest accuracy (AUC, 0.8; P = 0.24).
CONCLUSIONS
MET and MET+AZ antibiotic regimens in pediatric CD lead to distinct gut microbiota structures at remission. It may be possible to classify and predict remission based in part on microbiota profiles, but larger cohorts will be needed to realize this goal.",2019,"RESULTS
Both MET and MET+AZ significantly decreased diversity of the microbiota and caused large treatment-specific shifts in microbiota structure at week 4.","['16S rRNA-based microbiota profiling was performed on stool samples from 67 patients in a multinational', 'children with mild to moderate CD', ""Crohn's disease (CD""]","['metronidazole', 'MET+AZ', 'metronidazole (MET) and metronidazole plus azithromycin (MET+AZ']","['disease remission', 'Disease remission', 'classified disease remission']","[{'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1550661', 'cui_str': 'Feces specimen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.028647,"RESULTS
Both MET and MET+AZ significantly decreased diversity of the microbiota and caused large treatment-specific shifts in microbiota structure at week 4.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sprockett', 'Affiliation': 'Department of Microbiology & Immunology, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Fischer', 'Affiliation': 'Division of Infectious Diseases & Geographic Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Rotem Sigall', 'Initials': 'RS', 'LastName': 'Boneh', 'Affiliation': 'Pediatric Gastroenterology and Nutrition Unit, Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'The Juliet Keidan Institute of Pediatric Gastroenterology & Nutrition, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Jarek', 'Initials': 'J', 'LastName': 'Kierkus', 'Affiliation': ""Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Sladek', 'Affiliation': 'Department of Pediatrics, Gastroenterology and Nutrition, Jagiellonian University Medical College, Cracow, Poland.'}, {'ForeName': 'Johanna C', 'Initials': 'JC', 'LastName': 'Escher', 'Affiliation': ""Department of Pediatric Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.""}, {'ForeName': 'Eytan', 'Initials': 'E', 'LastName': 'Wine', 'Affiliation': 'Division of Pediatric Gastroenterology and Nutrition, Department of Pediatrics, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Baruch', 'Initials': 'B', 'LastName': 'Yerushalmi', 'Affiliation': 'Pediatric Gastroenterology Unit, Soroka University Medical Center, and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Jorge Amil', 'Initials': 'JA', 'LastName': 'Dias', 'Affiliation': 'Department of Pediatrics, Hospital de Sao Joao, Porto, Portugal.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Shaoul', 'Affiliation': ""Pediatric Gastroenterology Unit, Ruth Children's Hospital, Rambam Medical Center, Haifa, Israel.""}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kori', 'Affiliation': 'Pediatric Day Care Unit, Kaplan Medical Center, Rehovot, Israel.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'Snapper', 'Affiliation': ""Division of Gastroenterology, Hepatology, and Nutrition, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Holmes', 'Affiliation': 'Department of Statistics, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Athos', 'Initials': 'A', 'LastName': 'Bousvaros', 'Affiliation': ""Division of Gastroenterology, Hepatology, and Nutrition, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Levine', 'Affiliation': 'Pediatric Gastroenterology and Nutrition Unit, Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Relman', 'Affiliation': 'Department of Microbiology & Immunology, Stanford University School of Medicine, Stanford, California, USA.'}]",Inflammatory bowel diseases,['10.1093/ibd/izz130']
546,31875047,Habitual physical activity mediates the acute exercise-induced modulation of anxiety-related amygdala functional connectivity.,"Aerobic exercise, in relation to physical activity, has been shown to have beneficial effects on anxiety. However, the underlyig neural mechanism remains elusive. Using a within-subject crossover design, this fMRI study examined how exercise (12-min treadmill running versus walking) mediated amygdala reactivity to explicit and implicit (backward masked) perception of emotional faces in young adults (N = 40). Results showed that acute exercise-induced differences of state anxiety (STAI-S) varied as a function of individual's habitual physical activity (IPAQ). Subjects with high IPAQ levels showed significant STAI-S reduction (P < 0.05). Path analyses indicated that IPAQ explained 14.67% of the variance in acute exercise-induced STAI-S differences. Running elicited stronger amygdala reactivity to implicit happiness than fear, whereas walking did the opposite. The exercise-induced amygdala reactivity to explicit fear was associated with the IPAQ scores and STAI-S differences. Moreover, after running, the amygdala exhibited a positive functional connectivity with the orbitofrontal cortex and insula to implicit happiness, but a negative connectivity with the parahippocampus and subgenual cingulate to implicit fear. The findings suggest that habitual physical activity could mediate acute exercise-induced anxiolytic effects in regards to amygdala reactivity, and help establish exercise training as a form of anxiolytic therapy towards clinical applications.",2019,Subjects with high IPAQ levels showed significant STAI-S reduction (P < 0.05).,['young adults (N\u2009=\u200940'],"['Aerobic exercise', 'exercise (12-min treadmill running versus walking) mediated amygdala reactivity to explicit and implicit (backward masked) perception of emotional faces']","['STAI-S reduction', 'IPAQ scores and STAI-S differences', ""function of individual's habitual physical activity (IPAQ"", 'state anxiety (STAI-S']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0439781', 'cui_str': 'Backward (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.016382,Subjects with high IPAQ levels showed significant STAI-S reduction (P < 0.05).,"[{'ForeName': 'Yu-Chun', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Yang-Ming University Hospital, Yilan, Taiwan.'}, {'ForeName': 'Chenyi', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Injury Prevention and Control, College of Public Health, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Róger Marcelo', 'Initials': 'RM', 'LastName': 'Martínez', 'Affiliation': 'Graduate Institute of Injury Prevention and Control, College of Public Health, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Etnier', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, USA.'}, {'ForeName': 'Yawei', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Yang-Ming University Hospital, Yilan, Taiwan. ywcheng2@ym.edu.tw.'}]",Scientific reports,['10.1038/s41598-019-56226-z']
547,31222794,Impact of electrical pulse cut mode during endoscopic papillectomy: Pilot randomized clinical trial.,"OBJECTIVE
Endoscopic papillectomy is increasingly being used for ampullary adenoma treatment. However, it remains challenging despite increased safety with treatment advances. The ideal power output and electrosurgical current mode for mucosal resection are not established. We aimed to identify the ideal electrical pulse for use during resection.
METHODS
This pilot randomized, single-blind, prospective, multicenter trial, recruited patients with ampullary adenomas and conventional anatomy who were scheduled to undergo endoscopic papillectomy. Endoscopic treatment was performed using a standardized algorithm and patients were randomized for endoscopic papillectomy with Endocut or Autocut. The primary outcome was the incidence of delayed bleeding. Incidence of procedure-related pancreatitis, successful complete resection, pathological findings, and other adverse events were secondary endpoints.
RESULTS
Sixty patients were enrolled over a 2-year period. The incidences of delayed bleeding (13.3% vs. 16.7%, P = 1.00) and pancreatitis (27% vs. 30%, P = 0.77) were similar between both groups. The rate of crush artifacts was higher in the Endocut than in the Autocut group (27% vs. 3.3%, P = 0.03). Immediate bleeding when resecting tumors greater than 14 mm in diameter was more common in the Autocut than in the Endocut group (88% vs. 46%, P = 0.04).
CONCLUSIONS
The Autocut and Endocut modes have similar efficacy and safety for endoscopic papillectomy. The Endocut mode may prevent immediate bleeding in cases with large tumor sizes, although it causes more frequent crush artifacts.
REGISTRY AND THE REGISTRATION NUMBER
The Japanese UMIN Clinical Trials Registry (UMIN-CTR: 000021382).",2020,"Immediate bleeding when resecting tumors greater than 14 mm in diameter was more common in the Autocut than in the Endocut group (88% vs. 46%, p=0.04).
","['Sixty patients were enrolled over a 2-year period', 'recruited patients with ampullary adenomas and conventional anatomy who were scheduled to undergo endoscopic papillectomy']","['endoscopic papillectomy with Endocut or Autocut', 'electrical pulse cut mode']","['Incidence of procedure related pancreatitis, successful complete resection, pathological findings, and other adverse events', 'rate of crush artifacts', 'delayed bleeding', 'pancreatitis', 'incidence of delayed bleeding', 'Immediate bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0185060', 'cui_str': 'Crushing - action (qualifier value)'}, {'cui': 'C0085089', 'cui_str': 'Artifacts'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]",60.0,0.0915175,"Immediate bleeding when resecting tumors greater than 14 mm in diameter was more common in the Autocut than in the Endocut group (88% vs. 46%, p=0.04).
","[{'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Iwasaki', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Minami', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Itoi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kenjiro', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Shujiro', 'Initials': 'S', 'LastName': 'Tsuji', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Sofuni', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Tanaka', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Tonozuka', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Yujiro', 'Initials': 'Y', 'LastName': 'Machida', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Takimoto', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Tamagawa', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Katayama', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Kawasaki', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Seino', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Horibe', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Seiichiro', 'Initials': 'S', 'LastName': 'Fukuhara', 'Affiliation': 'Center for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Kitago', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Center for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Kanai', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}]",Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society,['10.1111/den.13468']
548,31859211,"Achieving Low Radiation Dose in ""One-Stop"" Myocardial Computed Tomography Perfusion Imaging in Coronary Artery Disease Using 16-cm Wide Detector CT.","RATIONALE AND OBJECTIVES
To investigate the feasibility of ""one-stop"" myocardial computed tomography perfusion (CTP) imaging (combined anatomy, perfusion, and function) in coronary artery disease using 16-cm wide detector CT, compared to conventional coronary CT angiography (CCTA).
MATERIALS AND METHODS
442 patients with suspected coronary artery disease were randomly divided into two groups. Patients in group A underwent ""one-stop"" CTP, whereas group B underwent conventional CCTA. Image quality of CT images was assessed. Radiation and contrast medium doses and scan time of the two groups were recorded. Group A was further divided into four subgroups according to the degree of coronary artery stenosis, for which transmural perfusion ratio (TPR) and left ventricular ejection fraction (LVEF) were measured.
RESULTS
Scan time was 73.1 ± 7.3 (s) longer in group A than in group B with 11.7% reduction of radiation dose (p < 0.001) and no significant difference in image quality was noted. Significant differences regarding the minimum TPR (F = 24.657, p < 0.001) and LVEF (χ 2 =36.98, p < 0.001) were observed among four subgroups. A negative correlation was found between the degree of coronary artery stenosis and TPR of the corresponding myocardial segments (r = -0.55, p < 0.001). Patients with moderate to severe arterial stenosis exhibited a decreased LVEF compared to those with normal coronary arteries (48.0% vs 56.5%, p < 0.001).
CONCLUSION
Compared to conventional CCTA, our new developed ""one-stop"" CTP may provide more comprehensive information on myocardial perfusion, coronary artery stenosis, and LV cardiac function with reduced radiation and contrast medium doses.",2020,"Significant differences regarding the minimum TPR (F = 24.657, p < 0.001) and LVEF (χ 2 =36.98, p < 0.001) were observed among four subgroups.",['442 patients with suspected coronary artery disease'],"['conventional CCTA', 'Low Radiation Dose in ""One-Stop"" Myocardial Computed Tomography Perfusion Imaging', 'conventional coronary CT angiography (CCTA', 'one-stop"" myocardial computed tomography perfusion (CTP) imaging (combined anatomy, perfusion, and function', 'one-stop"" CTP']","['transmural perfusion ratio (TPR) and left ventricular ejection fraction (LVEF', 'Scan time', 'degree of coronary artery stenosis and TPR of the corresponding myocardial segments', 'LVEF', 'minimum TPR', 'Image quality of CT images', 'image quality', 'severe arterial stenosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C2350393', 'cui_str': 'Perfusion Imaging'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0010734', 'cui_str': 'CRPPP'}]","[{'cui': 'C0522497', 'cui_str': 'Transmural (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0441633'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0242231', 'cui_str': 'Coronary Artery Stenosis'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038449', 'cui_str': 'Stricture of artery (disorder)'}]",442.0,0.02102,"Significant differences regarding the minimum TPR (F = 24.657, p < 0.001) and LVEF (χ 2 =36.98, p < 0.001) were observed among four subgroups.","[{'ForeName': 'Keling', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Kaiyue', 'Initials': 'K', 'LastName': 'Diao', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Sixian', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Jinge', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Wanlin', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Chunchao', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Yingkun', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Radiology, Key Laboratory of Birth Defects and Related Diseases of Women and Children of Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhenlin', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China. Electronic address: HX_lizhenlin@126.com.'}]",Academic radiology,['10.1016/j.acra.2019.11.018']
549,31796486,Effectiveness of home or hospital initiation of treatment at diagnosis for children with type 1 diabetes (DECIDE trial): a multicentre individually randomised controlled trial.,"OBJECTIVE
To determine whether, in children with newly diagnosed type 1 diabetes who were not acutely unwell, management at home for initiation of insulin treatment and education of the child and family, would result in improved clinical and psychological outcomes at 2 years postdiagnosis.
DESIGN
A multicentre randomised controlled trial (January 2008/October 2013).
SETTING
Eight paediatric diabetes centres in England, Wales and Northern Ireland.
PARTICIPANTS
203 clinically well children aged under 17 years, with newly diagnosed type 1 diabetes and their carers.
INTERVENTION
Management of the initiation period from diagnosis at home, for a minimum of 3 days, to include at least six supervised injections and delivery of pragmatic educational care.
MAIN OUTCOME MEASURES
Primary outcome was glycosylated haemoglobin (HbA1c) concentration at 24 months postdiagnosis. Secondary outcomes included coping, anxiety, quality of life and use of NHS resources.
RESULTS
203 children, newly diagnosed, were randomised to commence management at home (n=101) or in hospital (n=102). At the 24 month primary end point, there was one withdrawal and a follow-up rate of 194/202 (96%). Mean HbA1c in the home treatment arm was 72.1 mmol/mol and in the hospital treated arm 72.6 mmol/mol. There was a negligible difference between the mean HbA1c levels in the two arms adjusted for baseline (1.01, 95% CI 0.93 to 1.09). There were mostly no differences in secondary outcomes at 24 months, apart from better child self-esteem in the home-arm. No home-arm children were admitted to hospital during initiation and there were no adverse events at that time. The number of investigations was higher in hospital patients during the follow-up period. There were no differences in insulin regimens between the two arms.
CONCLUSIONS
There is no evidence of a difference between home-based and hospital-based initiation of care in children newly diagnosed with type 1 diabetes across relevant outcomes.
TRIAL REGISTRATION NUMBER
ISRCTN78114042.",2019,"There were mostly no differences in secondary outcomes at 24 months, apart from better child self-esteem in the home-arm.","['203 clinically well children aged under 17 years, with newly diagnosed type 1 diabetes and their carers', 'children with newly diagnosed type 1 diabetes who were not acutely unwell, management at home for initiation of insulin treatment and education of the child and family, would result in improved clinical and psychological outcomes at 2\u2009years postdiagnosis', '203 children, newly diagnosed, were randomised to commence management at home (n=101) or in hospital (n=102', 'children newly diagnosed with type 1 diabetes', 'children with type 1 diabetes', 'Eight paediatric diabetes centres in England, Wales and Northern Ireland']",[],"['number of investigations', 'coping, anxiety, quality of life and use of NHS resources', 'child self-esteem', 'mean HbA1c levels', 'Mean HbA1c', 'glycosylated haemoglobin (HbA1c) concentration']","[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0857256', 'cui_str': 'Unwell'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034380'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}]",203.0,0.280119,"There were mostly no differences in secondary outcomes at 24 months, apart from better child self-esteem in the home-arm.","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Gregory', 'Affiliation': 'Cardiff University, School of Medicine, Cardiff, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Townson', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK townson@cf.ac.uk.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Channon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'Health Economics and Policy Research Unit, University of South Wales, Pontypridd, UK.'}, {'ForeName': 'Mirella', 'Initials': 'M', 'LastName': 'Longo', 'Affiliation': 'Marie Curie Palliative Care Research Centre, Cardiff University, School of Medicine, Cardiff, UK.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': ""Southampton Children's Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Harman', 'Affiliation': 'University of Liverpool, Institute of Translational Medicine, Liverpool, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Pickles', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Playle', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Tabitha', 'Initials': 'T', 'LastName': 'Randell', 'Affiliation': ""Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust, Nottingham, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Morro', 'Initials': 'M', 'LastName': 'Touray', 'Affiliation': 'School of Biosciences and Medicine, University of Surrey, Guildford, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Trevelyan', 'Affiliation': ""Southampton Children's Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Warner', 'Affiliation': 'Department of Child Health, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Lowes', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032317']
550,29788198,Venous Thromboembolism After Intraventricular Hemorrhage: Results From the CLEAR III Trial.,"BACKGROUND
Venous thromboembolism (VTE) after intracerebral hemorrhage is well studied, but data on patients with spontaneous intraventricular hemorrhage (IVH) are limited.
OBJECTIVE
To study the factors associated with VTE, association between VTE and clinical outcomes in IVH, and safety of VTE chemoprophylaxis in IVH treated with intraventricular catheters and thrombolysis.
METHODS
Retrospective cohort study of patients enrolled in the CLEAR III trial, a multicenter, randomized trial comparing external ventricular drainage, with administration of intraventricular alteplase vs placebo, for obstructive IVH. Predictor variable was incident VTE in the first 30 d. Outcome measures were factors associated with VTE, and death/severe disability (modified Rankin Score 4-6) at 6 mo.
RESULTS
Of the 500 patients with IVH, VTE occurred in 59 patients (11.8%) within the first 30 d. VTE chemoprophylaxis was initiated in 412 (82.4%) patients, but before VTE diagnosis in only 401 (80.2%) at median of 4 d (interquartile range, 1-8) from IVH onset, and was not associated with intracranial bleeding or catheter tract hemorrhage. In the multivariate logistic regression analysis, infection within 30 d (odds ratio, 1.80; confidence interval, 1.03-3.17) was significantly associated with higher odds of VTE occurrence. Starting VTE chemoprophylaxis after 72 h was additionally associated with VTE occurrence after the first week.
CONCLUSION
Infection and delay in timely initiation of VTE chemoprophylaxis were associated with VTE occurrence. VTE chemoprophylaxis in IVH appears safe and should not be delayed beyond standard care policies for ICH including when intraventricular catheter placement and thrombolytic therapy are performed.",2019,"In the multivariate logistic regression analysis, infection within 30 d (odds ratio, 1.80; confidence interval, 1.03-3.17) was significantly associated with higher odds of VTE occurrence.","['patients with spontaneous intraventricular hemorrhage (IVH', 'After Intraventricular Hemorrhage', 'Retrospective cohort study of patients enrolled in the CLEAR III trial', '500 patients with IVH']","['external ventricular drainage, with administration of intraventricular alteplase vs placebo']","['Venous Thromboembolism', 'VTE, and death/severe disability', 'VTE occurrence', 'intracranial bleeding or catheter tract hemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}]","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0948930', 'cui_str': 'Ventricular drainage'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",500.0,0.0943951,"In the multivariate logistic regression analysis, infection within 30 d (odds ratio, 1.80; confidence interval, 1.03-3.17) was significantly associated with higher odds of VTE occurrence.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurosurgery,['10.1093/neuros/nyy189']
551,31899004,Fidelity and feasibility of a multicomponent physical activity intervention in a retirement community.,"This pilot study examined the fidelity and feasibility of a multicomponent physical activity intervention in a retirement community. Eighteen older adults participated in an 8-week intervention. The intervention included offering group exercise lessons, combined with providing participants wearable activity trackers. Quantitative and qualitative data were collected to assess the feasibility and fidelity. The retention of the study was 83.3% and the average attendance of group lessons was 88.2%. Participants wore the activity trackers on 93.9% of the required days. Individual interviews indicated that participants were generally satisfied with the intervention. However, the Tai Chi session of exercise lessons and the activity trackers were not favored by the majority of the participants. Future interventions should provide tailored and adaptable exercise programs to meet the various physical health conditions of older adults and ease the use of technology to facilitate behavior change.",2020,"However, the Tai Chi session of exercise lessons and the activity trackers were not favored by the majority of the participants.",['Eighteen older adults participated in an 8-week intervention'],"['group exercise lessons, combined with providing participants wearable activity trackers', 'multicomponent physical activity intervention']","['feasibility and fidelity', 'activity trackers']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise (regime/therapy)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}]",18.0,0.0174244,"However, the Tai Chi session of exercise lessons and the activity trackers were not favored by the majority of the participants.","[{'ForeName': 'Zhanjia', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giordani', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Weiyun', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, MI 48109, USA. Electronic address: chenwy@umich.edu.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2019.12.002']
552,31799628,Evaluation of the effectiveness of a tailored mobile application in increasing the duration of wear of thermoplastic retainers: a randomized controlled trial.,"BACKGROUND
The 'My Retainers' mobile application is a patient-informed intervention designed to enhance removable retainer wear and associated patient experiences during the retention phase.
OBJECTIVES
To evaluate the effect of receiving the 'My Retainers' application on objectively assessed thermoplastic retainer (TPR) wear time, stability, periodontal outcomes, patient experiences, and knowledge related to retainers.
MATERIALS AND METHODS
Eighty-four participants planned for removable retention with TPRs were assigned either to receive the 'My Retainers' application or to control not receiving electronic reminders during the 3-month period. Randomization was based on computer-generated random numbers and allocation was concealed using opaque, sealed envelopes. The primary outcome was objectively assessed retainer wear recorded using an embedded TheraMon® micro-electronic sensor. Secondary outcomes, including irregularity of the maxillary and mandibular incisors, plaque levels, bleeding on probing and probing depth, were assessed at baseline and 3-month follow-up; and analysed using a series of mixed models. Experiences and knowledge related to orthodontic retainers were recorded using questionnaires. The outcome assessor was blinded when possible.
RESULTS
Receipt of the mobile application resulted in slightly higher median wear time (0.91 hours/day); however, this difference was not statistically significant (P = 0.56; 95% confidence interval [CI]: -2.19, 4.01). No significant differences were found between the treatment groups in terms of stability (P = 0.92; 95% CI: -0.03, 0.04), plaque levels (P = 0.44; 95% CI: -0.07, 0.03), bleeding on probing (P = 0.61; 95% CI: -0.05, 0.03) and probing depth (P = 0.79; 95% CI: -0.09, 0.07). Furthermore, similar levels of patient experiences (P = 0.94) and knowledge related to retainers (P = 0.26) were found. However, marginally better levels of knowledge were identified in the intervention group. No harms were observed.
LIMITATIONS
A relatively short follow-up period with the study confined to a single-center in a university-based hospital.
CONCLUSIONS
Provision of the bespoke 'My Retainers' application did not lead to an improvement in adherence with TPR wear over a 3-month follow-up period. Further refinement and research are required to develop and investigate means of enhancing adherence levels.
CLINICAL REGISTRATION
NCT03224481.",2020,"No significant differences were found between the treatment groups in terms of stability (P = 0.92; 95% CI: -0.03, 0.04), plaque levels (P = 0.44; 95% CI: -0.07, 0.03), bleeding on probing (P = 0.61; 95% CI: -0.05, 0.03) and probing depth (P = 0.79; 95% CI: -0.09, 0.07).",['Eighty-four participants planned for removable retention with TPRs'],"['tailored mobile application', ""My Retainers' application or to control not receiving electronic reminders""]","['median wear time', 'stability', 'duration of wear of thermoplastic retainers', 'irregularity of the maxillary and mandibular incisors, plaque levels, bleeding on probing and probing depth', 'retainer wear recorded using an embedded TheraMon® micro-electronic sensor', 'thermoplastic retainer (TPR) wear time, stability, periodontal outcomes, patient experiences, and knowledge related to retainers', 'plaque levels', 'probing depth', 'bleeding on probing']","[{'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4551580', 'cui_str': 'Retainer (attribute)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",84.0,0.151108,"No significant differences were found between the treatment groups in terms of stability (P = 0.92; 95% CI: -0.03, 0.04), plaque levels (P = 0.44; 95% CI: -0.07, 0.03), bleeding on probing (P = 0.61; 95% CI: -0.05, 0.03) and probing depth (P = 0.79; 95% CI: -0.09, 0.07).","[{'ForeName': 'Dalya', 'Initials': 'D', 'LastName': 'Al-Moghrabi', 'Affiliation': 'Centre for Oral Bioengineering, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, UK.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Pandis', 'Affiliation': 'Department of Orthodontics, Dental School, Medical Faculty, University of Bern, Switzerland; Private practice, Corfu, Greece.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'McLaughlin', 'Affiliation': 'Centre for Oral Bioengineering, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, UK.'}, {'ForeName': 'Ama', 'Initials': 'A', 'LastName': 'Johal', 'Affiliation': 'Centre for Oral Bioengineering, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, UK.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Donos', 'Affiliation': 'Centre for Oral Immunobiology and Regenerative Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, UK.'}, {'ForeName': 'Padhraig S', 'Initials': 'PS', 'LastName': 'Fleming', 'Affiliation': 'Centre for Oral Bioengineering, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, UK.'}]",European journal of orthodontics,['10.1093/ejo/cjz088']
553,31806612,Is congruent movement training more effective than standard visual scanning therapy to ameliorate symptoms of visuospatial neglect? Study protocol of a randomised control trial.,"INTRODUCTION
Approximately 30% of all patients with stroke show visuospatial neglect (VSN). Currently, visual scanning therapy (VST) is applied in clinical settings to attenuate neglect symptoms. VST builds on the premise that eye movements to the affected hemifield lead to a concurrent shift of visual attention. Congruent movements with different effectors of the motor system, for example, eye and hand, can produce an even larger boost of attention compared with a single effector. This congruency principle may produce a powerful bias in the motor system, which may counteract the pathological biases in the attentional system of neglect patients. Therefore, an intervention with congruent eye and hand movements may result in greater attenuation of neglect compared with an intervention with single eye movements as applied in standard VST. The current randomised controlled trial will investigate the beneficial effects of this updated version of VST by comparing changes in performance on standard neuropsychological neglect tasks and severity of neglect in activities of daily living.
METHODS AND ANALYSIS
Thirty VSN patients in the subacute phase poststroke onset will be randomly assigned to one of two groups: congruent eye and hand movement training (experimental group) versus standard VST (control group). Each patient will receive 10 sessions of training, 30 min each, within 2 weeks. Performance on standard neuropsychological neglect tasks, a visual discrimination task, severity of neglect in ADL and eye movement characteristics before and after intervention will be compared for and between both groups.
ETHICS AND DISSEMINATION
This study has been approved by the ethical committee of the University Medical Centre Utrecht. All subjects will participate voluntarily and will give written informed consent. Results of this study will be published in peer-reviewed scientific journals and presented at international conferences.
TRIAL REGISTRATION NUMBER
NTR7005.",2019,"Congruent movements with different effectors of the motor system, for example, eye and hand, can produce an even larger boost of attention compared with a single effector.","['Thirty VSN patients in the subacute phase poststroke onset', 'patients with stroke show visuospatial neglect (VSN']","['visual scanning therapy (VST', 'congruent eye and hand movement training (experimental group) versus standard VST', 'standard visual scanning therapy', 'VST']","['visual discrimination task, severity of neglect in ADL and eye movement characteristics']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439853', 'cui_str': 'Congruent (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}]",,0.167482,"Congruent movements with different effectors of the motor system, for example, eye and hand, can produce an even larger boost of attention compared with a single effector.","[{'ForeName': 'Joris A', 'Initials': 'JA', 'LastName': 'Elshout', 'Affiliation': 'Experimental Psychology, Utrecht University, Utrecht, The Netherlands j.a.elshout@uu.nl.'}, {'ForeName': 'Tanja C W', 'Initials': 'TCW', 'LastName': 'Nijboer', 'Affiliation': 'Experimental Psychology, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Van der Stigchel', 'Affiliation': 'Experimental Psychology, Utrecht University, Utrecht, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-031884']
554,31895298,"Lactalbumin, Not Collagen, Augments Muscle Protein Synthesis with Aerobic Exercise.","INTRODUCTION
Protein ingestion and the ensuing hyperaminoacidemia stimulates skeletal muscle protein synthesis in the postexercise period. This response facilitates muscle remodeling, which is important during intensified training. The aim of this study was to determine whether supplementation with α-lactalbumin (LA), with high leucine and tryptophan contents, would improve responses to short periods of intensified aerobic training compared with supplementation with an isonitrogenous quantity of collagen peptides (CP).
METHODS
Endurance-trained participants (5 male, 6 female, 24 ± 4 yr, V˙O2 = 53.2 ± 9.1 mL·kg·min, peak power output = 320 ± 48 W; means ± SD) consumed a controlled diet (1.0 g·kg·d protein) and refrained from habitual training for 11 d while taking part in this double-blind randomized, crossover trial. The two intervention phases, which consisted of brief intensified training (4 × 4-min cycling intervals at 70% of peak power output on 3 consecutive days) combined with the ingestion of LA or CP supplements after exercise (20 g) and before sleep (40 g), were separated by 4 d of washout without protein supplementation (i.e., the control phase). In response to each phase, myofibrillar (MyoPS), sarcoplasmic protein synthesis (SarcPS) rates (via H2O ingestion) and parameters of sleep quality were measured.
RESULTS
LA ingestion increased plasma leucine (P < 0.001) and tryptophan concentrations (P < 0.001) relative to CP. Intensified training increased MyoPS and SarcPS above the washout phase in LA- and CP-supplemented phases (P < 0.01), with increases being 13% ± 5% and 5% ± 7% greater with LA than CP for MyoPS (P < 0.01) and SarcPS, respectively (P < 0.01).
CONCLUSIONS
Despite an isonitrogenous diet, protein synthesis was enhanced to a greater extent when trained participants consumed LA compared with CP during intensified aerobic training, suggesting that protein quality is an important consideration for endurance-trained athletes aiming to augment adaption to exercise training.",2020,LA ingestion increased plasma leucine (p<0.001) and tryptophan concentrations (p<0.001) relative to CP.,"['Endurance trained participants (5M, 6F, 24 ± 4 years, V[Combining']","['brief intensified training (4×4-min cycling intervals at 70% of PPO on 3 consecutive days) combined with the ingestion of LA or CP supplements post-exercise', 'supplementation with α-Lactalbumin (LA']","['myofibrillar (MyoPS), sarcoplasmic protein synthesis (SarcPS) rates (via H2O ingestion) and parameters of sleep quality', 'plasma leucine (p<0.001) and tryptophan concentrations (p<0.001) relative to CP', 'MyoPS and SarcPS']","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0022912', 'cui_str': 'Lactalbumin'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3177469', 'cui_str': '(pipzH2)(cdo)H2O'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]",320.0,0.0426972,LA ingestion increased plasma leucine (p<0.001) and tryptophan concentrations (p<0.001) relative to CP.,"[{'ForeName': 'Sara Y', 'Initials': 'SY', 'LastName': 'Oikawa', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, Ontario, CANADA.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Macinnis', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, Ontario, CANADA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Tripp', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, Ontario, CANADA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'McGlory', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, Ontario, CANADA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Baker', 'Affiliation': 'Department of Neurology, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, CANADA.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, Ontario, CANADA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002253']
555,31841875,Virtual mind-body treatment for geographically diverse youth with neurofibromatosis: A pilot randomized controlled trial.,"OBJECTIVE
To examine the feasibility, acceptability, preliminary effect, and durability of a mind-body videoconferencing program for youth with neurofibromatosis (Resilient Youth with NF; RY-NF) against an experimental educational control (Health Education for NF; HE-NF) via a single-blind pilot RCT.
METHOD
Adolescents with NF (N = 51; age 12-17) completed baseline assessments and were randomized (1:1/ to intervention or experimental educational control). The multiple primary outcomes were physical health and psychological quality of life (QoL). Secondary outcomes were social relations QoL, environmental QoL, depression, anxiety, pain intensity and pain interference. Posttreatment and at 6-month follow-up assessments were collected.
RESULTS
Forty-five adolescents (88%) completed posttreatment, and 37 (82%) completed 6-month follow-up. Satisfaction was high in both conditions. The RY-NF showed greater baseline to posttreatment improvements in physical health QoL (10.18; 95% CI: 0.47-19.90; p = .040), psychological QoL (9.45; 95% CI: 0.78-18.11; p = .033), social relations QoL (13.19; 95% CI: 1.87-24.50; p = .023), and environmental QoL (9.26; 95% CI: 3.49-15.49; p = .002), compared to the HE-NF (between group effects). Improvements were clinically meaningful and maintained through follow-up.
CONCLUSIONS
The RY-NF was well accepted, highly feasible and resulted in sustained improvement in QoL, demonstrating adolescents are receptive to and benefit from learning resiliency skills in groups via live video.",2020,"The RY-NF showed greater baseline to posttreatment improvements in physical health QoL (10.18; 95% CI: 0.47-19.90; p = .040), psychological QoL (9.45; 95% CI: 0.78-18.11; p = .033), social relations QoL (","['geographically diverse youth with neurofibromatosis', 'Adolescents with NF (N\xa0=\xa051; age 12-17) completed baseline assessments and were randomized ', 'Forty-five adolescents (88%) completed posttreatment, and 37 (82%) completed 6-month follow-up', 'youth with neurofibromatosis (Resilient Youth with NF']","['Virtual mind-body treatment', 'mind-body videoconferencing program']","['social relations QoL, environmental QoL, depression, anxiety, pain intensity and pain interference', 'physical health and psychological quality of life (QoL', 'Satisfaction', 'social relations QoL ', 'psychological QoL', 'physical health QoL', 'environmental QoL']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0162678', 'cui_str': 'Multiple Neurofibromas'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",45.0,0.148729,"The RY-NF showed greater baseline to posttreatment improvements in physical health QoL (10.18; 95% CI: 0.47-19.90; p = .040), psychological QoL (9.45; 95% CI: 0.78-18.11; p = .033), social relations QoL (","[{'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Lester', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America. Electronic address: elester@mgh.harvard.edu.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'DiStefano', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, Boston, MA, United States of America. Electronic address: sdistefano1@mgh.harvard.edu.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Mace', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America. Electronic address: rmace@mgh.harvard.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Macklin', 'Affiliation': 'Harvard Medical School, Boston, MA, United States of America; Biostatistics Center, Massachusetts General Hospital, Boston, MA, United States of America. Electronic address: emacklin@mgh.harvard.edu.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Plotkin', 'Affiliation': 'Harvard Medical School, Boston, MA, United States of America; Neurofibromatosis Clinic, Massachusetts General Hospital, Boston, MA, United States of America. Electronic address: splotkin@mgh.harvard.edu.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America. Electronic address: avranceanu@mgh.harvard.edu.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2019.12.001']
556,31858245,"Cholelithiasis after bariatric surgery, incidence, and prophylaxis: randomized controlled trial.","BACKGROUND
Rapid weight loss is associated with a high incidence of cholelithiasis.
OBJECTIVES
To identify the incidence of gallstone formation after weight loss surgery and to detect the efficacy of 6 months regimen of prophylactic Ursodeoxycholic acid (UDCA).
METHODS
RCT included a total of 1530 morbid obese patients who were subjected to either laparoscopic one anastomosis gastric bypass (OAGB), sleeve gastrectomy (SG), or greater curve plication (GCP). Patients with previous or concomitant cholecystectomy and missed follow-up were excluded, leaving 1432 patients to analyze. They were randomly allocated into two groups receiving either UDCA or placebo with a minimum follow-up of one year for assessment of cholelithiasis and weight loss.
RESULTS
The overall incidence of cholelithiasis after surgery was 9.7%. There was a significant decrease in the incidence of gallstone formation from 22% in placebo to 6.5% in treated group with UDCA. The mean percentage of excess weight loss (%EWL) was significantly higher in those who develop gallstones than others. Of those developing gallstones, there was 64.7 % with SG versus 28.1% and 7.2% in OAGB and GCP, respectively, which is statistically significant. NNT to prevent cholelithiasis is six, AR% is 70.4%, and RR is 3.4%.
CONCLUSIONS
Cholelithiasis after SG and OAGB was higher than GCP. %EWL was rapid and higher in OAGB and SG contributing to the higher rate of symptomatic cholelithiasis and could be predictive for post-bariatric cholelithiasis. A 6-month use of UDCA is an effective prophylaxis decreasing gallstone formation after bariatric surgery at short-term follow-up.",2020,%EWL was rapid and higher in OAGB and SG contributing to the higher rate of symptomatic cholelithiasis and could be predictive for post-bariatric cholelithiasis.,"['Patients with previous or concomitant cholecystectomy and missed follow-up were excluded, leaving 1432 patients to analyze', 'RCT included a total of 1530 morbid obese patients who were subjected to either']","['UDCA or placebo', 'UDCA', 'placebo', 'laparoscopic one anastomosis gastric bypass (OAGB), sleeve gastrectomy (SG), or greater curve plication (GCP', 'prophylactic Ursodeoxycholic acid (UDCA']","['gallstone formation', 'overall incidence of cholelithiasis', 'mean percentage of excess weight loss', 'incidence of gallstone formation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C4708917', 'cui_str': 'One thousand four hundred and thirty-two'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C1175868', 'cui_str': 'GCP (supplement)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}]","[{'cui': 'C0947622', 'cui_str': 'Cholecystolithiasis'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0008350', 'cui_str': 'Cholelithiasis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",1530.0,0.0765713,%EWL was rapid and higher in OAGB and SG contributing to the higher rate of symptomatic cholelithiasis and could be predictive for post-bariatric cholelithiasis.,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Talha', 'Affiliation': 'Department of Surgery, Medical Research Institute, Alexandria University, Alexandria, Egypt. ahmedtalha047@yahoo.com.'}, {'ForeName': 'Tamer', 'Initials': 'T', 'LastName': 'Abdelbaki', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Alexandria University, 165, Horreya Avenue, Hadara, Alexandria, 21561, Egypt.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Farouk', 'Affiliation': 'Department of Surgery, Medical Research Institute, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Ehab', 'Initials': 'E', 'LastName': 'Hasouna', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Azzam', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Gihan', 'Initials': 'G', 'LastName': 'Shehata', 'Affiliation': 'Department of Biomedical Informatics and Medical Statistics, Medical Research Institute, Alexandria University, Alexandria, Egypt.'}]",Surgical endoscopy,['10.1007/s00464-019-07323-7']
557,30429127,Effects of a low carbohydrate diet on energy expenditure during weight loss maintenance: randomized trial.,"OBJECTIVE
To determine the effects of diets varying in carbohydrate to fat ratio on total energy expenditure.
DESIGN
Randomized trial.
SETTING
Multicenter collaboration at US two sites, August 2014 to May 2017.
PARTICIPANTS
164 adults aged 18-65 years with a body mass index of 25 or more.
INTERVENTIONS
After 12% (within 2%) weight loss on a run-in diet, participants were randomly assigned to one of three test diets according to carbohydrate content (high, 60%, n=54; moderate, 40%, n=53; or low, 20%, n=57) for 20 weeks. Test diets were controlled for protein and were energy adjusted to maintain weight loss within 2 kg. To test for effect modification predicted by the carbohydrate-insulin model, the sample was divided into thirds of pre-weight loss insulin secretion (insulin concentration 30 minutes after oral glucose).
MAIN OUTCOME MEASURES
The primary outcome was total energy expenditure, measured with doubly labeled water, by intention-to-treat analysis. Per protocol analysis included participants who maintained target weight loss, potentially providing a more precise effect estimate. Secondary outcomes were resting energy expenditure, measures of physical activity, and levels of the metabolic hormones leptin and ghrelin.
RESULTS
Total energy expenditure differed by diet in the intention-to-treat analysis (n=162, P=0.002), with a linear trend of 52 kcal/d (95% confidence interval 23 to 82) for every 10% decrease in the contribution of carbohydrate to total energy intake (1 kcal=4.18 kJ=0.00418 MJ). Change in total energy expenditure was 91 kcal/d (95% confidence interval -29 to 210) greater in participants assigned to the moderate carbohydrate diet and 209 kcal/d (91 to 326) greater in those assigned to the low carbohydrate diet compared with the high carbohydrate diet. In the per protocol analysis (n=120, P<0.001), the respective differences were 131 kcal/d (-6 to 267) and 278 kcal/d (144 to 411). Among participants in the highest third of pre-weight loss insulin secretion, the difference between the low and high carbohydrate diet was 308 kcal/d in the intention-to-treat analysis and 478 kcal/d in the per protocol analysis (P<0.004). Ghrelin was significantly lower in participants assigned to the low carbohydrate diet compared with those assigned to the high carbohydrate diet (both analyses). Leptin was also significantly lower in participants assigned to the low carbohydrate diet (per protocol).
CONCLUSIONS
Consistent with the carbohydrate-insulin model, lowering dietary carbohydrate increased energy expenditure during weight loss maintenance. This metabolic effect may improve the success of obesity treatment, especially among those with high insulin secretion.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02068885.",2018,Change in total energy expenditure was 91 kcal/d (95% confidence interval -29 to 210) greater in participants assigned to the moderate carbohydrate diet and 209 kcal/d (91 to 326) greater in those assigned to the low carbohydrate diet compared with the high carbohydrate diet.,"['Multicenter collaboration at US two sites, August 2014 to May 2017', '164 adults aged 18-65 years with a body mass index of 25 or more']",['low carbohydrate diet'],"['contribution of carbohydrate to total energy intake', 'energy expenditure during weight loss maintenance', 'weight loss', 'Leptin', 'total energy expenditure', 'total energy expenditure, measured with doubly labeled water, by intention-to-treat analysis', 'resting energy expenditure, measures of physical activity, and levels of the metabolic hormones leptin and ghrelin', 'Total energy expenditure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}]",164.0,0.0975545,Change in total energy expenditure was 91 kcal/d (95% confidence interval -29 to 210) greater in participants assigned to the moderate carbohydrate diet and 209 kcal/d (91 to 326) greater in those assigned to the low carbohydrate diet compared with the high carbohydrate diet.,"[{'ForeName': 'Cara B', 'Initials': 'CB', 'LastName': 'Ebbeling', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Division of Endocrinology, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA 02115, USA.""}, {'ForeName': 'Henry A', 'Initials': 'HA', 'LastName': 'Feldman', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Gloria L', 'Initials': 'GL', 'LastName': 'Klein', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Division of Endocrinology, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA 02115, USA.""}, {'ForeName': 'Julia M W', 'Initials': 'JMW', 'LastName': 'Wong', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Division of Endocrinology, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA 02115, USA.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bielak', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Division of Endocrinology, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA 02115, USA.""}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Steltz', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Division of Endocrinology, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA 02115, USA.""}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Luoto', 'Affiliation': 'Department of Food and Nutrition, Framingham State University, Framingham, MA, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Wolfe', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Wong', 'Affiliation': ""USDA/ARS Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA.""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Ludwig', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Division of Endocrinology, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA 02115, USA david.ludwig@childrens.harvard.edu.""}]",BMJ (Clinical research ed.),['10.1136/bmj.k4583']
558,31896686,Early progression of disease predicts shorter survival in MALT lymphoma patients receiving systemic treatment.,"Early progression of disease (POD) within two years from diagnosis is linked with poor overall survival (OS) in follicular lymphoma but its prognostic role is less clear in extranodal marginal zone B-cell lymphoma (EMZL). We sought to identify prognostic factors associated with early POD and to determine whether is associated with inferior OS. We analyzed the impact of early POD in the IELSG19 clinical trial dataset (training set of 401 patients randomly assigned to chlorambucil or rituximab or chlorambucil plus rituximab). Reproducibility was examined in a validation set of 287 patients who received systemic treatment. In both sets, we excluded from the analysis the patients who, within 24 months from treatment start, died without progression or were lost to follow-up without prior progression. OS was calculated from progression in patients with early POD and from 24 months after start of treatment in those without (reference group). Early POD was observed in 69 of the 384 (18%) evaluable patients of the IELSG19 study. Patients with high-risk MALT-IPI were more likely to have early POD (p=0.006). The 10-year OS rate was 64% in the early POD group and 85% in the reference group (HR= 2.42, 95%CI, 1.35-4.34; log-rank P=0.002). This prognostic impact was confirmed in the validation set, in which early POD was observed in 64 out of 224 (29%) evaluable patients with 10-year OS rate of 48% in the early POD group and 71% in the reference group (HR= 2.15, 95%CI, 1.19-3.90; log-rank P=0.009). In patients with EMZL who received front-line systemic treatment, early POD is associated with poorer survival and may represent a useful endpoint in future prospective clinical trials.",2020,Patients with high-risk MALT-IPI were more likely to have early POD (p=0.006).,"['Patients with high-risk MALT-IPI', '401 patients randomly assigned to', 'MALT lymphoma patients receiving systemic treatment', '287 patients who received systemic treatment']",['chlorambucil or rituximab or chlorambucil plus rituximab'],"['10-year OS rate', 'Early POD', 'Early progression of disease (POD', 'Reproducibility']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0024651', 'cui_str': 'Malt'}, {'cui': 'C0668760', 'cui_str': ""P(1),P(5)-di(inosine-5')pentaphosphate""}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0242647', 'cui_str': 'Mucosa-Associated Lymphoid Tissue Lymphoma'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}]","[{'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",401.0,0.0634302,Patients with high-risk MALT-IPI were more likely to have early POD (p=0.006).,"[{'ForeName': 'Annarita', 'Initials': 'A', 'LastName': 'Conconi', 'Affiliation': 'Division of Hematology, Ospedale degli Infermi, Biella, Italy; annarita.conconi@aslbi.piemonte.it.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Thieblemont', 'Affiliation': 'Hemato-Oncology Department, Saint Louis Hospital, Paris, France.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Cascione', 'Affiliation': 'Institute of Oncology Research, Bellinzona, Switzerland.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Clinical Research Methodology Laboratory, IRCCS Mario Negri Institute, Milan, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kiesewetter', 'Affiliation': 'Division of Oncology, Department of Internal Medicine I, Medical University of Vienna,Vienna,Austria.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Margiotta Casaluci', 'Affiliation': 'Division of Hematology, Dept. of Translational Medicine, University of Eastern Piedmont,Novara,Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Gaidano', 'Affiliation': 'Division of Hematology, Dept. of Translational Medicine, University of Eastern Piedmont,Novara,Italy.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Raderer', 'Affiliation': 'Division of Oncology, Department of Internal Medicine I, Medical University of Vienna,Vienna,Austria.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Cavalli', 'Affiliation': 'Institute of Oncology Research, Bellinzona, Switzerland.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Lopez Guillermo', 'Affiliation': 'Department of Hematology, Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Johnson', 'Affiliation': 'Cancer Research UK Center, Southampton General Hospital, Southampton, United Kingdom.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Zucca', 'Affiliation': 'Division of Medical Oncology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}]",Haematologica,['10.3324/haematol.2019.237990']
559,31882606,The effect of mindfulness training on extinction retention.,"Anxiety and trauma related disorders are highly prevalent, causing suffering and high costs for society. Current treatment strategies, although effective, only show moderate effect-sizes when compared to adequate control groups demonstrating a need to develop new forms of treatment or optimize existing ones. In order to achieve this, an increased understanding of what mechanisms are involved is needed. An emerging literature indicates that mindfulness training (MFT) can be used to treat fear and anxiety related disorders, but the treatment mechanisms are unclear. One hypothesis, largely based on findings from neuroimaging studies, states that MFT may improve extinction retention, but this has not been demonstrated empirically. To investigate this question healthy subjects either completed a 4-week MFT- intervention delivered through a smart-phone app (n = 14) or were assigned to a waitlist (n = 15). Subsequently, subjects participated in a two-day experimental protocol using pavlovian aversive conditioning, evaluating acquisition and extinction of threat-related responses on day 1, and extinction retention on day 2. Results showed that the MFT group displayed reduced spontaneous recovery of threat related arousal responses, as compared to the waitlist control group, on day 2. MFT did not however, have an effect on either the acquisition or extinction of conditioned responses day 1. This clarifies the positive effect of MFT on emotional functioning and could have implications for the treatment of anxiety and trauma related disorders.",2019,"Results showed that the MFT group displayed reduced spontaneous recovery of threat related arousal responses, as compared to the waitlist control group, on day 2.",['question healthy subjects either completed a 4-week'],"['mindfulness training', 'MFT', 'mindfulness training (MFT', 'MFT- intervention delivered through a smart-phone app']","['spontaneous recovery of threat related arousal responses', 'extinction retention']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.0144693,"Results showed that the MFT group displayed reduced spontaneous recovery of threat related arousal responses, as compared to the waitlist control group, on day 2.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Björkstrand', 'Affiliation': 'Department of Psychology, University of Southern Denmark, Odense, Denmark. johannes.bjorkstrand@psyk.uu.se.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Schiller', 'Affiliation': 'Departments of Psychiatry and Neuroscience, and Friedman Brain Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Psychological and Cognitive Sciences and Beijing Key Laboratory of Behavior and Mental Health, Peking University, Beijing, China.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Davidson', 'Affiliation': 'Department of Psychology, Lund University, Lund, Sweden.'}, {'ForeName': 'Jörgen', 'Initials': 'J', 'LastName': 'Rosén', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Mårtensson', 'Affiliation': 'Department of Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Kirk', 'Affiliation': 'Department of Psychology, University of Southern Denmark, Odense, Denmark.'}]",Scientific reports,['10.1038/s41598-019-56167-7']
560,31883327,Perioperative fosfomycin disodium prophylaxis against urinary tract infection in renal transplant recipients: a randomized clinical trial.,"BACKGROUND
Symptomatic urinary tract infection (UTI) is the most common infectious complication in renal transplant recipients (RTRs). Fosfomycin (FOS) is an attractive alternative for prophylaxis because it does not interact with immunosuppressants; although 90% is excreted unchanged in the urine, it does not require adjustment for renal function for single dose prophylaxis.
METHODS
RTRs were recruited into this randomized, double-blind, placebo-controlled trial. Participants were randomized (1:1) to receive one 4 g dose of FOS disodium intravenously 3 h (FOS group) or placebo (placebo group) before placement and removal of a urinary catheter and before removal of a double-J ureteral stent. All participants received prophylaxis with trimethoprim/sulfamethoxazole. The main outcome was a comparison of the mean number of symptomatic UTI and asymptomatic bacteriuria (AB) episodes per patient during a 7-week follow-up period. The study was registered at ClinicalTrials.gov, NTC03235947.
RESULTS
Eighty-two participants were included (41 in the FOS group and 41 in placebo group). The mean number of AB or symptomatic UTI episodes per patient was lower in the FOS group [intention-to-treat (ITT) 0.29 versus 0.60, P = 0.04]. The incidence of symptomatic UTI was lower in the FOS group (ITT, 7.3% versus 36.6%, P = 0.001), and there was no difference in the incidence of AB between both groups. The incidence of adverse events was similar in both groups.
CONCLUSIONS
FOS addition is an effective and safe strategy to reduce the number of symptomatic UTIs during the first 7 weeks after renal transplant.",2020,"The incidence of symptomatic UTI was lower in the FOS group (ITT, 7.3% versus 36.6%, P = 0.001), and there was no difference in the incidence of AB between both groups.","['renal transplant recipients', 'Eighty-two participants were included (41 in the FOS group and 41 in placebo group', 'RTRs', 'renal transplant recipients (RTRs']","['Fosfomycin (FOS', 'placebo', 'FOS disodium intravenously 3\u2009h (FOS group) or placebo (placebo group) before placement and removal of a urinary catheter and before removal of a double-J ureteral stent', 'trimethoprim/sulfamethoxazole', 'Perioperative fosfomycin disodium prophylaxis']","['incidence of symptomatic UTI', 'incidence of AB', 'adverse events', 'mean number of symptomatic UTI and asymptomatic bacteriuria (AB) episodes', 'mean number of AB or symptomatic UTI episodes per patient']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}, {'cui': 'C0771948', 'cui_str': 'Fosfomycin disodium'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0262380', 'cui_str': 'Asymptomatic bacteriuria (finding)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",82.0,0.577132,"The incidence of symptomatic UTI was lower in the FOS group (ITT, 7.3% versus 36.6%, P = 0.001), and there was no difference in the incidence of AB between both groups.","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Rosado-Canto', 'Affiliation': 'Department of Medicine, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Idalia', 'Initials': 'I', 'LastName': 'Parra-Avila', 'Affiliation': 'Department of Nephrology-Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Tejeda-Maldonado', 'Affiliation': 'Department of Nephrology-Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Cristopher', 'Initials': 'C', 'LastName': 'Kauffman-Ortega', 'Affiliation': 'Department of Urology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Francisco T', 'Initials': 'FT', 'LastName': 'Rodriguez-Covarrubias', 'Affiliation': 'Department of Urology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Mariedel', 'Initials': 'M', 'LastName': 'Trujeque-Matos', 'Affiliation': 'Department of Nephrology-Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Cruz-Martínez', 'Affiliation': 'Department of Transplantation, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Maravilla-Franco', 'Affiliation': 'Laboratory of Clinical Microbiology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Elia', 'Initials': 'E', 'LastName': 'Criollo-Mora', 'Affiliation': 'Department of Pharmacy, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Arreola-Guerra', 'Affiliation': 'Department of Medicine, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Morales-Buenrostro', 'Affiliation': 'Department of Nephrology-Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Sifuentes-Osornio', 'Affiliation': 'Department of Medicine, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, México.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz261']
561,31893730,Individual predictors of response to biofeedback training for second-language production.,"While recent research suggests that visual biofeedback can facilitate speech production training in clinical populations and second language (L2) learners, individual learners' responsiveness to biofeedback is highly variable. This study investigated the hypothesis that the type of biofeedback provided, visual-acoustic versus ultrasound, could interact with individuals' acuity in auditory and somatosensory domains. Specifically, it was hypothesized that learners with lower acuity in a sensory domain would show greater learning in response to biofeedback targeting that domain. Production variability and phonological awareness were also investigated as predictors. Sixty female native speakers of English received 30 min of training, randomly assigned to feature visual-acoustic or ultrasound biofeedback, for each of two Mandarin vowels. On average, participants showed a moderate magnitude of improvement (decrease in Euclidean distance from a native-speaker target) across both vowels and biofeedback conditions. The hypothesis of an interaction between sensory acuity and biofeedback type was not supported, but phonological awareness and production variability were predictive of learning gains, consistent with previous research. Specifically, high phonological awareness and low production variability post-training were associated with better outcomes, although these effects were mediated by vowel target. This line of research could have implications for personalized learning in both L2 pedagogy and clinical practice.",2019,"The hypothesis of an interaction between sensory acuity and biofeedback type was not supported, but phonological awareness and production variability were predictive of learning gains, consistent with previous research.","[""individuals' acuity in auditory and somatosensory domains"", 'Sixty female native speakers of English received']","['visual biofeedback', '30\u2009min of training, randomly assigned to feature visual-acoustic or ultrasound biofeedback', 'visual-acoustic versus ultrasound', 'biofeedback training']","['Euclidean distance', 'Production variability and phonological awareness']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",60.0,0.0456901,"The hypothesis of an interaction between sensory acuity and biofeedback type was not supported, but phonological awareness and production variability were predictive of learning gains, consistent with previous research.","[{'ForeName': 'Joanne Jingwen', 'Initials': 'JJ', 'LastName': 'Li', 'Affiliation': 'Department of Communicative Sciences and Disorders, New York University, 665 Broadway, Suite 900, New York, New York 10012, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Ayala', 'Affiliation': 'Department of Communicative Sciences and Disorders, New York University, 665 Broadway, Suite 900, New York, New York 10012, USA.'}, {'ForeName': 'Daphna', 'Initials': 'D', 'LastName': 'Harel', 'Affiliation': 'Department of Applied Statistics, Social Science, and Humanities, New York University, 246 Greene Street, 3rd Floor, New York, New York 10003, USA.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Shiller', 'Affiliation': ""École d'orthophonie et d'audiologie, Université de Montréal, Case Postale 6128, Succursale Centre-ville, Montréal, Québec, H3C 3J7, Canada.""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'McAllister', 'Affiliation': 'Department of Communicative Sciences and Disorders, New York University, 665 Broadway, Suite 900, New York, New York 10012, USA.'}]",The Journal of the Acoustical Society of America,['10.1121/1.5139423']
562,31811007,"COveRs to impRove AesthetiC ouTcome after Surgery for Chronic subdural haemAtoma by buRr hole trepanation (CORRECT-SCAR): protocol of a Swiss single-blinded, randomised controlled trial.","INTRODUCTION
Outcomes rated on impairment scales are satisfactory after burr hole trepanation for chronic subdural haematoma (cSDH). However, the surgery leads to bony defects in the skull with skin depressions above that are frequently considered aesthetically unsatisfactory by the patients. Those defects could be covered by the approved medical devices (burr hole covers), but this is rarely done today. We wish to assess, whether the application of burr hole covers after trepanation for the evacuation of cSDH leads to higher patient satisfaction with the aesthetical result at 90 days postoperative, without worsening disability outcomes or increasing the complication rate.
METHODS AND ANALYSIS
This is a prospective, single-blinded, randomised, controlled, investigator-initiated clinical trial enrolling 80 adult patients with first-time unilateral or bilateral cSDH in Switzerland. The primary outcome is the difference in satisfaction with the aesthetic result of the scar, comparing patients allocated to the intervention (burr hole cover) and control (no burr hole cover) group, measured on the Aesthetic Numeric Analogue scale at 90 days postoperative. Secondary outcomes include differences in the rates of skin depression, complications, as well as neurological, disability and health-related quality of life outcomes until 12 months postoperative.
ETHICS AND DISSEMINATION
The institutional review board (Kantonale Ethikkommission Zürich) approved this study on 29 January 2019 under case number BASEC 2018-01180. This study determines, whether a relatively minor modification of a standard surgical procedure can improve patient satisfaction, without worsening functional outcomes or increasing the complication rate. The outcome corresponds to the value-based medicine approach of modern patient-centred medicine. Results will be published in peer-reviewed journals and electronic patient data will be safely stored for 15 years.
TRIAL REGISTRATION NUMBER
NCT03755349.",2019,"INTRODUCTION
Outcomes rated on impairment scales are satisfactory after burr hole trepanation for chronic subdural haematoma (cSDH).","['80 adult patients with first-time unilateral or bilateral cSDH in Switzerland', '29 January 2019 under case number BASEC 2018-01180']",[],"['rates of skin depression, complications, as well as neurological, disability and health-related quality of life outcomes until 12 months postoperative', 'complication rate', 'satisfaction with the aesthetic result of the scar', 'Aesthetic Numeric Analogue scale', 'patient satisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",[],"[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0222045'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",80.0,0.160525,"INTRODUCTION
Outcomes rated on impairment scales are satisfactory after burr hole trepanation for chronic subdural haematoma (cSDH).","[{'ForeName': 'Martin N', 'Initials': 'MN', 'LastName': 'Stienen', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland mnstienen@gmail.com.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Akeret', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Vasella', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Velz', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Jehli', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Scheffler', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stefanos', 'Initials': 'S', 'LastName': 'Voglis', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bichsel', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Nicolas Roydon', 'Initials': 'NR', 'LastName': 'Smoll', 'Affiliation': 'School of Population and Global Health, University of Melbourne, Melbourne, Sydney, Australia.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bozinov', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Regli', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Menno R', 'Initials': 'MR', 'LastName': 'Germans', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-031375']
563,31818841,Efficacy of a web-based self-help tool to reduce problem gambling in Switzerland: study protocol of a two-armed randomised controlled trial.,"INTRODUCTION
The past-year prevalence of problem gambling worldwide averages 2.3%. Switzerland exhibits a slightly lower past-year prevalence rate, of 1.1%, among adults. Only a minority of these adults attend outpatient treatment. Surveyed problem gamblers have explained that they wanted to handle the problem on their own. The option of a web-based self-help programme could potentially reach those users who hesitate to approach treatment centres and help them to reduce or stop their problem gambling. The effectiveness of such web-based interventions has been shown in other countries.
METHODS AND ANALYSIS
This two-armed randomised controlled trial (RCT) will examine the efficacy of a web-based self-help intervention, relative to an active control condition with a self-help manual, at reducing problem gambling. The active intervention programme, spanning 8 weeks, consists of nine modules developed to reduce gambling and attenuate psychopathological comorbidity, including depression, anxiety and stress-related disorder symptoms, relying on motivational interviewing and cognitive behavioural therapy. With a target sample size of 352, questionnaire data will be collected at baseline, and at 8 and 24 weeks after baseline. Primary outcomes will be the number of days one has gambled in the last 30 days. Secondary outcomes will include money and time spent on gambling activities, changes in gambling-related problems (Problem Gambling Severity Index, Gambling Symptom Assessment Scale), use of alcohol and cigarettes, and psychopathological comorbidity. All data analysis will comply with the intention-to-treat principle.
ETHICS AND DISSEMINATION
The RCT will be conducted in accordance with the Declaration of Helsinki; the consort eHealth Guidelines for studies on medical devices; the European Directive on medical devices 93/42/EEC, Swiss Law and Swiss Regulatory Authority requirements. The study was approved by the ethics committee of the Canton of Zurich. Results will be published in a scientific peer-reviewed journal. Participants will be informed via e-mail about study results via a lay-person-friendly summary of trial findings.
TRIAL REGISTRATION NUMBER
Current Controlled Trials registry (ISRCTN16339434).",2019,"This two-armed randomised controlled trial (RCT) will examine the efficacy of a web-based self-help intervention, relative to an active control condition with a self-help manual, at reducing problem gambling.",['problem gambling in Switzerland'],"['motivational interviewing and cognitive behavioural therapy', 'web-based self-help tool']","['money and time spent on gambling activities, changes in gambling-related problems (Problem Gambling Severity Index, Gambling Symptom Assessment Scale), use of alcohol and cigarettes, and psychopathological comorbidity', 'number of days one has gambled in the last 30 days']","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0222045'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.270937,"This two-armed randomised controlled trial (RCT) will examine the efficacy of a web-based self-help intervention, relative to an active control condition with a self-help manual, at reducing problem gambling.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Baumgartner', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland christian.baumgartner@isgf.uzh.ch.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bilevicius', 'Affiliation': 'Department of Psychology, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Khazaal', 'Affiliation': 'Addiction Medicine, Department of Psychiatry, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Achab', 'Affiliation': 'WHO Collaborating Centre for Training and Research in Mental Health, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Schaaf', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wenger', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Haug', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Keough', 'Affiliation': 'Department of Psychology, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hodgins', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Schaub', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2019-032110']
564,31818266,"Protocol for a prospective, cluster randomized trial to evaluate routine and deferred dialysis initiation (RADDI) in Chinese population.","BACKGROUND
The timing of when to initiate dialysis for progressive chronic kidney disease (CKD) patients has not been well established. There has been a strong trend for early dialysis initiation for these patients over the past decades. However, the perceived survival advantage of early dialysis has been questioned by a series of recent observational studies. The only randomized controlled trial (RCT) research on this issue found the all-cause mortality, comorbidities, and quality of life showed no difference between early and late dialysis starters. To better understand optimal timing for dialysis initiation, our research will evaluate the efficacy and safety of deferred dialysis initiation in a large Chinese population.
METHODS
The trial adopts a multicenter, cluster randomized, single-blind (outcomes assessor), and endpoint-driven design. Eligible participants are 18-80 years old, in stable CKD stages 4-5 (eGFR > 7 ml/min /1.73 m 2 ), and with good heart function (NYHA grade I or II). Participants will be randomized into a routine or deferred dialysis group. The reference eGFR at initiating dialysis for asymptomatic patients is 7 ml/min /1.73 m 2 (routine dialysis group) and 5 ml/min/1.73 m 2 or less (deferred dialysis group) in each group. The primary endpoint will be the difference of all-cause mortality and acute nonfatal cerebro-cardiovascular events between the two groups. The secondary outcomes include hospitalization rate and other safety indices. The primary and secondary outcomes will be analyzed by appropriate statistical methods.
DISCUSSION
This study protocol represents a large, cluster randomized study evaluating deferred and routine dialysis intervention for an advanced CKD population. The reference eGFR to initiate dialysis for both treatment groups is targeted at less than 7 ml/min/1.73m 2 . With this design, we aim to eliminate lead-time and survivor bias and avoid selection bias and confounding factors. We acknowledge that the study has limitations. Even so, given the low-targeted eGFR values of both arms, this study still has potential economic, health, and scientific implications. This research is unique in that such a low targeted eGFR value has never been studied in a clinical trial.
TRIAL REGISTRATION
The trial has been approved by ClinicalTrials.gov (Trial registration ID NCT02423655). The date of registration was April 22, 2015.",2019,The primary endpoint will be the difference of all-cause mortality and acute nonfatal cerebro-cardiovascular events between the two groups.,"['progressive chronic kidney disease (CKD) patients', 'Chinese population', 'Eligible participants are 18-80\u2009years old, in stable CKD stages 4-5 (eGFR >\u20097\u2009ml/min /1.73', 'advanced CKD population']","['routine and deferred dialysis initiation (RADDI', 'routine dialysis intervention']","['difference of all-cause mortality and acute nonfatal cerebro-cardiovascular events', 'hospitalization rate and other safety indices', 'mortality, comorbidities, and quality of life']","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C2317473', 'cui_str': 'CKD stage 4'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034380'}]",,0.178398,The primary endpoint will be the difference of all-cause mortality and acute nonfatal cerebro-cardiovascular events between the two groups.,"[{'ForeName': 'Xinju', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Lining', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Xiaonong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Nephrology, Beijing Tongren Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Department of Nephrology, Beijing Hospital, National Center of Gerontology, Beijing, China.'}, {'ForeName': 'Rihong', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': 'Department of Nephrology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Department of Nephrology, Shaanxi Hospital of Traditional Chinese Medicine, Shaanxi, China.'}, {'ForeName': 'Caili', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of Baotou Medical College, Baotou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Sichuan Academy of Medical Sciences, Chengdu, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Kidney disease center, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Detian', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yuzhu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Beijing Haidian Hospital (Beijing Haidian Section of Peking University Third Hospital), Beijing, China.'}, {'ForeName': 'Wenling', 'Initials': 'W', 'LastName': 'Ye', 'Affiliation': 'Department of Nephrology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Renal Division, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Jia', 'Affiliation': 'Department of Nephrology, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Peking University Clinical Research Institute, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China. zuoli@bjmu.edu.cn.""}]",BMC nephrology,['10.1186/s12882-019-1627-0']
565,31759769,Subjects with high fasting insulin also have higher postprandial GLP-1 and glucagon levels than controls with lower insulin.,"Little is known about postprandial release of serum ghrelin, glucagon, and glucagon-like peptide-1 (GLP-1) in relation with differing fasting insulin levels. We hypothesized that these hormones are affected by insulin resistance, and hence, we compared different postprandial responses of GLP-1, glucagon, and ghrelin in subjects with relatively high (RHI) or relatively low (RLI) fasting insulin levels. The trial was a randomized crossover study with 4 different meal conditions. Fourteen nonobese or obese, healthy, men and 14 women were randomly assigned to the order of supervised intake of a 750 kcal drink with the same protein contents but with 20 energy-percent (E%) or 55 E% from carbohydrates, and the remaining energy from fat. Participants were also randomized to consume the drinks as 1 large beverage or as five 150-kcal portions every 30 minutes. The 28 subjects were divided into 2 equally sized groups based on fasting insulin levels. Statistics were done with general linear mixed model. Fasting insulin levels were 3-fold higher in the group with RHI compared with the RLI group (RHI: 1004 ± 510 pg/mL, RLI: 324 ± 123 pg/mL, P < .0005). Serum GLP-1 was highest in the RHI group after both single meals and after 5 drinks and following high- and low-carbohydrate meals (both P ≤ .002), and this was the case also for glucagon levels (both P ≤ .018), whereas ghrelin levels did not differ between groups. Thus, subjects with RHI displayed both higher postprandial serum GLP-1 and glucagon than the participants with RLI, suggesting that glucagon could play a role in the advent of dysglycemia by insulin resistance.",2019,"Fasting insulin levels were 3-fold higher in the group with RHI compared with the RLI group (RHI: 1004 ± 510 pg/mL, RLI: 324 ± 123 pg/mL, P < .0005).","['subjects with relatively high (RHI) or relatively low (RLI) fasting insulin levels', 'Fourteen nonobese or obese, healthy, men and 14 women', '28 subjects']","['supervised intake of a 750\u202fkcal drink with the same protein contents but with 20 energy-percent (E%) or 55 E% from carbohydrates, and the remaining energy from fat']","['glucagon levels', 'postprandial serum GLP-1 and glucagon', 'postprandial GLP-1 and glucagon levels', 'Serum GLP-1', 'fasting insulin levels', 'ghrelin levels', 'Fasting insulin levels']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0015677', 'cui_str': 'Fats'}]","[{'cui': 'C0337437', 'cui_str': 'Glucagon test (procedure)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",14.0,0.0383113,"Fasting insulin levels were 3-fold higher in the group with RHI compared with the RLI group (RHI: 1004 ± 510 pg/mL, RLI: 324 ± 123 pg/mL, P < .0005).","[{'ForeName': 'Erina', 'Initials': 'E', 'LastName': 'Albinsson-Stenholm', 'Affiliation': 'Department of Medical and Health Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bergsén', 'Affiliation': 'Department of Medical and Health Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ingves', 'Affiliation': 'Department of Medical and Health Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Vilhelmsson', 'Affiliation': 'Department of Medical and Health Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Guldbrand', 'Affiliation': 'Department of Medical and Health Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Fredrik H', 'Initials': 'FH', 'LastName': 'Nystrom', 'Affiliation': 'Department of Medical and Health Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden. Electronic address: fredrik.h.nystrom@liu.se.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2019.10.009']
566,31819122,Population-based volume kinetics of crystalloids and colloids in healthy volunteers.,"We characterized the volume kinetics of crystalloid solutions (Ringer's lactate solution and 5% dextrose water) and colloid solutions (6% tetrastarch and 10% pentastarch) by nonlinear mixed-effects modeling in healthy volunteers. We also assessed whether the bioelectrical impedance analysis parameters are significant covariates for volume kinetic parameters. Twelve male volunteers were randomly allocated to four groups, and each group received the four fluid solutions in specified sequences, separated by 1-week intervals to avoid any carryover effects. Volunteers received 40 ml/kg Ringer's lactate solution, 20 ml/kg 5% dextrose water, 1000 ml 6% tetrastarch, and 1000 ml 10% pentastarch over 1 h. Arterial blood samples were collected to measure the hemoglobin concentration at different time points. Bioelectrical impedance spectroscopy (BIS, INBODY S10, InBody CO., LTD, Seoul, Korea) was also carried out at preset time points. In total, 671 hemoglobin-derived plasma dilution data points were used to determine the volume kinetic characteristics of each fluid. The changes in plasma dilution induced by administration of crystalloid and colloid solutions were well-described by the two-volume and one-volume models, respectively. Extracellular water was a significant covariate for the peripheral volume of distribution at baseline in the volume kinetic model of Ringer's lactate solution. When the same amount was administered, the colloid solutions had ~4 times more plasma expansion effect than did the crystalloid solutions. Starches with larger molecular weights maintained the volume expansion effect longer than those with smaller molecular weights.",2019,"When the same amount was administered, the colloid solutions had ~4 times more plasma expansion effect than did the crystalloid solutions.","['Twelve male volunteers', 'healthy volunteers']","[""40\u2009ml/kg Ringer's lactate solution, 20\u2009ml/kg 5% dextrose water, 1000\u2009ml 6% tetrastarch"", ""crystalloid solutions (Ringer's lactate solution and 5% dextrose water) and colloid solutions (6% tetrastarch and 10% pentastarch""]","['plasma expansion effect', 'Bioelectrical impedance spectroscopy (BIS, INBODY S10, InBody CO., LTD, Seoul, Korea', 'plasma dilution', 'hemoglobin concentration']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C1816356', 'cui_str': 'Product containing tetrastarch'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C2350383', 'cui_str': 'Pentastarch'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0162536', 'cui_str': 'Bioelectrical Impedance'}, {'cui': 'C2713504', 'cui_str': 'Spectroscopy'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0079240', 'cui_str': 'Dilution Technics'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}]",12.0,0.0609498,"When the same amount was administered, the colloid solutions had ~4 times more plasma expansion effect than did the crystalloid solutions.","[{'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Yi', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Korea.""}, {'ForeName': 'Ji-Yeon', 'Initials': 'JY', 'LastName': 'Bang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Bohyun', 'Initials': 'B', 'LastName': 'Choi', 'Affiliation': 'Department of Nursing, Graduate School and College of Nursing Science, KyungHee University, Seoul, Korea.'}, {'ForeName': 'Changhun', 'Initials': 'C', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yong-Hun', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Eun-Kyung', 'Initials': 'EK', 'LastName': 'Lee', 'Affiliation': 'Department of Statistics, Ewha Womans University, Seoul, Korea.'}, {'ForeName': 'Byung-Moon', 'Initials': 'BM', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. byungmoonchoi7@gmail.com.'}, {'ForeName': 'Gyu-Jeong', 'Initials': 'GJ', 'LastName': 'Noh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine and Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}]",Scientific reports,['10.1038/s41598-019-55171-1']
567,31844133,Effect of diaphragm and abdominal muscle training on pelvic floor strength and endurance: results of a prospective randomized trial.,"Pelvic floor muscles (PFMs) play a crucial role in urinary continence. Therefore, training the PFMs remains the most popular conservative treatment for urinary incontinence (UI). The effect of training other body muscles on the PFMs is unclear and mostly hypothetical. The objective of our study was to evaluate the effectiveness of postoperative diaphragm muscle, abdominal muscle and PFM training on PFM strength (PFMS) and endurance (PFME) as well as on UI in men after radical prostatectomy (RP). Per-protocol PFMS, PFME and urine loss measurements were performed at 1, 3, and 6 months postoperatively. The primary endpoints were PFMS and PFME differences among the study groups. The secondary endpoint was the correlation between UI and PFMS and PFME. In total, 148 men were randomized to the treatment groups. An increase in PFMS and PFME was observed in all groups compared to baseline (p < 0.001). The greatest difference in PFMS was in the PFM training group, but diaphragm training had the best effect on PFME. The highest (from moderate to strong) correlation between UI and PFME and PFMS (r = -0.61 and r = -0.89, respectively) was observed in the diaphragm training group. Despite different but significant effects on PFMS and PFME, all rehabilitation-training programmes decreased UI in men after RP.",2019,"Despite different but significant effects on PFMS and PFME, all rehabilitation-training programmes decreased UI in men after RP.","['men after radical prostatectomy (RP', '148 men']","['diaphragm training', 'postoperative diaphragm muscle, abdominal muscle and PFM training', 'diaphragm and abdominal muscle training']","['PFMS and PFME differences', 'correlation between UI and PFMS and PFME', 'PFMS and PFME', 'pelvic floor strength and endurance', 'PFMS', 'UI and PFME and PFMS', 'PFM strength (PFMS) and endurance (PFME']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0000739', 'cui_str': 'Abdominal Muscles'}]","[{'cui': 'C0633055', 'cui_str': 'PFME'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]",148.0,0.015208,"Despite different but significant effects on PFMS and PFME, all rehabilitation-training programmes decreased UI in men after RP.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zachovajeviene', 'Affiliation': 'Lithuanian University of Health Sciences, Medical Academy, Clinic of Sport Medicine, Kaunas, Lithuania.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Siupsinskas', 'Affiliation': 'Lithuanian University of Health Sciences, Medical Academy, Clinic of Sport Medicine, Kaunas, Lithuania.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zachovajevas', 'Affiliation': 'Lithuanian Sport University, Department of Health Promotion and Rehabilitation, Kaunas, Lithuania.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Venclovas', 'Affiliation': 'Lithuanian University of Health Sciences, Medical Academy, Department of Urology, Kaunas, Lithuania.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Milonas', 'Affiliation': 'Lithuanian University of Health Sciences, Medical Academy, Department of Urology, Kaunas, Lithuania. Daimantas.Milonas@kaunoklinikos.lt.'}]",Scientific reports,['10.1038/s41598-019-55724-4']
568,31844146,Effects of a comprehensive intervention on hypertension control in Chinese employees working in universities based on mixed models.,"We conducted a comprehensive intensive intervention for hypertension patients working in universities or colleges. From July 2015 to March in 2016, 220 hypertension subjects were recruited, with 165 cases in intensive intervention group and 55 in standard intervention group. After 24 months of intervention, 208 ones including of 157 in intensive intervention group and 51 in standard intervention group were included in the final analysis. The patients in standard intervention group were given routine intervention, which mainly including of drug treatment and health education. The patients in intervention group were given comprehensive intensive intervention in addition to routine intervention, including follow-up management of hypertension, emotional, lifestyle intervention and else. The study and experimental protocols were approved by institutional review board of Zhejiang Hospital and Fu Wai Hospital and registered (ChiCTR-ECS-14004641, date of registration: May 8, 2014). After 2 years, compared with the standard intervention group, SBP/DBP in the intensive intervention group decreased by 3.7/4 mmHg and BP control rate increased by 8.9%, and the unhealthy behaviors and life quality including tension and pressure were also improved in the intensive intervention group. We used mixed effect model to analyze the intervention effect which could solve the problems of missing values and correlation. The intensive intervention of hypertension control including follow-up management, emotional and lifestyle intervention in occupational places could promote the development of the prevention, treatment and control of hypertension among staff in colleges and universities.",2019,"After 2 years, compared with the standard intervention group, SBP/DBP in the intensive intervention group decreased by 3.7/4 ","['From July 2015 to March in 2016, 220 hypertension subjects were recruited, with 165 cases in intensive intervention group and 55 in standard intervention group', 'hypertension patients working in universities or colleges', 'Chinese employees working in universities based on mixed models']","['comprehensive intensive intervention', 'intensive intervention of hypertension control including follow-up management, emotional and lifestyle intervention', 'comprehensive intervention', 'comprehensive intensive intervention in addition to routine intervention, including follow-up management of hypertension, emotional, lifestyle intervention and else', 'routine intervention, which mainly including of drug treatment and health education']","['mmHg and BP control rate', 'hypertension control', 'SBP/DBP', 'unhealthy behaviors and life quality including tension and pressure']","[{'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018701'}]","[{'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0034380'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",220.0,0.0260555,"After 2 years, compared with the standard intervention group, SBP/DBP in the intensive intervention group decreased by 3.7/4 ","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Zhejiang Provincial Center for Cardiovascular Disease Control and Prevention, Zhejiang Hospital, Hangzhou, 310013, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Xiaoqing', 'Affiliation': 'Chinese Acupuncture Department, Zhejiang Hospital, Hangzhou, 310013, China.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Xinhua', 'Affiliation': 'Zhejiang Provincial Center for Cardiovascular Disease Control and Prevention, Zhejiang Hospital, Hangzhou, 310013, China.'}, {'ForeName': 'Shou', 'Initials': 'S', 'LastName': 'Xiaoling', 'Affiliation': 'Zhejiang Provincial Center for Cardiovascular Disease Control and Prevention, Zhejiang Hospital, Hangzhou, 310013, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Xiaoling', 'Affiliation': 'Zhejiang Provincial Center for Cardiovascular Disease Control and Prevention, Zhejiang Hospital, Hangzhou, 310013, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Zhejiang Provincial Center for Cardiovascular Disease Control and Prevention, Zhejiang Hospital, Hangzhou, 310013, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Zengwu', 'Affiliation': 'Department of Community Prevention and Control, National Cardiovascular Disease Center, Fuwai Hospital, BeiJing, 102308, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Xin', 'Affiliation': 'Department of Community Prevention and Control, National Cardiovascular Disease Center, Fuwai Hospital, BeiJing, 102308, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Pinpin', 'Affiliation': 'Key Laboratory of Public Health Safety, Ministry of Education, Health Communication Institute, Fudan University, 138 Yixueyuan Road, Shanghai, 200032, China. zpinpin@shmu.edu.cn.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jing', 'Affiliation': 'Zhejiang Provincial Center for Cardiovascular Disease Control and Prevention, Zhejiang Hospital, Hangzhou, 310013, China. phoebe84331@163.com.'}]",Scientific reports,['10.1038/s41598-019-55849-6']
569,31848765,Telephone-Delivered Mindfulness Training to Promote Medication Adherence and Reduce Sexual Risk Behavior Among Persons Living with HIV: An Exploratory Clinical Trial.,"This study explored whether telephone-delivered mindfulness training (MT) to promote medication adherence and reduce sexual risk behavior was feasible for and acceptable to people living with HIV. Participants (N = 42; 50% female; M age = 47.5 years) were randomized to MT or health coaching (HC). Pre- and post-intervention, and at 3-month follow-up, we assessed adherence to ART, sexual risk behavior, and hypothesized mediators; we also conducted individual interviews to obtain qualitative data. Results showed that 55% of patients assigned to MT completed ≥ 50% of the training calls compared with 86% of HC patients (p < .05). Most patients reported satisfaction with their intervention (MT = 88%, HC = 87%). Patients in MT and HC reported improvements in medication adherence, mindfulness, and sexual risk reduction as well as reductions in anxiety, depressive symptoms, perceived stress, and impulsivity over time; however, no between-groups differences were observed.",2020,"Patients in MT and HC reported improvements in medication adherence, mindfulness, and sexual risk reduction as well as reductions in anxiety, depressive symptoms, perceived stress, and impulsivity over time; however, no between-groups differences were observed.","['people living with HIV', 'Participants (N\u2009=\u200942; 50% female; M age\u2009=\u200947.5\xa0years', 'Persons Living with HIV']","['telephone-delivered mindfulness training (MT', 'MT or health coaching (HC', 'Telephone-Delivered Mindfulness Training']","['Sexual Risk Behavior', 'anxiety, depressive symptoms, perceived stress, and impulsivity over time', 'adherence to ART, sexual risk behavior, and hypothesized mediators', 'medication adherence, mindfulness, and sexual risk reduction']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",,0.0292532,"Patients in MT and HC reported improvements in medication adherence, mindfulness, and sexual risk reduction as well as reductions in anxiety, depressive symptoms, perceived stress, and impulsivity over time; however, no between-groups differences were observed.","[{'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Carey', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, CORO West, Suite 309, 164 Summit Avenue, Providence, RI, 02903, USA. Michael_Carey@brown.edu.'}, {'ForeName': 'Eugene M', 'Initials': 'EM', 'LastName': 'Dunne', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, CORO West, Suite 309, 164 Summit Avenue, Providence, RI, 02903, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Norris', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, CORO West, Suite 309, 164 Summit Avenue, Providence, RI, 02903, USA.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Dunsiger', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, CORO West, Suite 309, 164 Summit Avenue, Providence, RI, 02903, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Rich', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, CORO West, Suite 309, 164 Summit Avenue, Providence, RI, 02903, USA.'}, {'ForeName': 'Rochelle K', 'Initials': 'RK', 'LastName': 'Rosen', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, CORO West, Suite 309, 164 Summit Avenue, Providence, RI, 02903, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': 'Department of Behavioral and Social Science, School of Public Health, Brown University, Providence, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Salmoirago-Blotcher', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, CORO West, Suite 309, 164 Summit Avenue, Providence, RI, 02903, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02768-2']
570,31197730,Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers in a Primary Care Practice Network.,"BACKGROUND
Population-based strategies can expand the reach of tobacco cessation treatment beyond clinical encounters.
OBJECTIVE
To determine the effect of two population-based tobacco cessation strategies, compared with usual care, on providing tobacco treatment outside of clinical encounters.
DESIGN
3-arm pragmatic randomized controlled trial.
PARTICIPANTS
Current smokers ≥ 18 years old with a primary care provider at one of five community health centers in Massachusetts were identified via the electronic health record (n = 5225) and recruited using automated phone calls.
INTERVENTIONS
One intervention group involved engagement with a health system-based tobacco coach (internal care coordination), and the other connected patients to a national quitline (external community referral).
MEASUREMENTS
Proportion of smokers with documentation of any evidence-based cessation treatment in the 6 months after enrollment.
KEY RESULTS
Of 639 individuals who responded to the proactive treatment offer, 233 consented and were randomized 1:1:1 to study arm. At 6-month follow-up, the pooled intervention group, compared with usual care, had higher documentation of any smoking cessation treatment (63% vs. 34%, p < 0.001), cessation medication prescription (52% vs. 30%, p = 0.002), and counseling (47% vs. 9%, p < 0.001). Internal care coordination was more effective than external community referral at connecting smokers to any cessation treatment (76% vs. 50%, p = 0.001) and at providing cessation medication (66% vs. 39%, p < 0.001), but comparable at linking smokers to cessation counseling resources.
CONCLUSIONS
Smokers responding to a population-based, proactive outreach strategy had better provision of tobacco cessation treatment when referred to either a health system-based or community-based program compared with usual care. The health system-based strategy outperformed the quitline-based one in several measures. Future work should aim to improve population reach and test the effect on smoking cessation rates.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03612895.",2019,"Internal care coordination was more effective than external community referral at connecting smokers to any cessation treatment (76% vs. 50%, p = 0.001) and at providing cessation medication (66% vs. 39%, p < 0.001), but comparable at linking smokers to cessation counseling resources.
","['18\xa0years old with a primary care provider at one of five community health centers in Massachusetts were identified via the electronic health record (n\u2009=\u20095225) and recruited using automated phone calls', '639 individuals who responded to the proactive treatment offer, 233 consented', 'Current smokers ≥']","['One intervention group involved engagement with a health system-based tobacco coach (internal care coordination), and the other connected patients to a national quitline (external community referral']","['cessation medication prescription', 'higher documentation of any smoking cessation treatment']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C3241966'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0034927', 'cui_str': 'Referral'}]","[{'cui': 'C2239117', 'cui_str': 'Drug Prescribing'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0765875,"Internal care coordination was more effective than external community referral at connecting smokers to any cessation treatment (76% vs. 50%, p = 0.001) and at providing cessation medication (66% vs. 39%, p < 0.001), but comparable at linking smokers to cessation counseling resources.
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kalkhoran', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA. skalkhoran@mgh.harvard.edu.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Inman', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Jennifer H K', 'Initials': 'JHK', 'LastName': 'Kelley', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Ashburner', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05079-3']
571,31338563,"A Vitamin D, Calcium and Leucine-Enriched Whey Protein Nutritional Supplement Improves Measures of Bone Health in Sarcopenic Non-Malnourished Older Adults: The PROVIDE Study.","Alterations in musculoskeletal health with advanced age contribute to sarcopenia and decline in bone mineral density (BMD) and bone strength. This decline may be modifiable via dietary supplementation. To test the hypothesis that a specific oral nutritional supplement can result in improvements in measures of bone health. Participants (n 380) were participants of the PROVIDE study, a 13-week, multicenter, randomized, controlled, double-blind, 2 parallel-group study among non-malnourished older participants (≥ 65 years) with sarcopenia [determined by Short Physical Performance Battery (SPPB; 0-12) scores between 4 and 9, and a low skeletal muscle mass index (SMI; skeletal muscle mass/BW × 100) ≤ 37% in men and ≤ 28% in women using bioelectric impedance analysis] Supplementation of a vitamin D, calcium and leucine-enriched whey protein drink that comprises a full range of micronutrients (active; 2/day) was compared with an iso-caloric control. Serum 25-hydroxyvitamin D [25(OH)D], parathyroid hormone (PTH), biochemical markers of bone formation (osteocalcin; OC, procollagen type 1 amino-terminal propeptide; P1NP) and resorption (carboxy-terminal collagen crosslinks; CTX), insulin like growth factor 1 (IGF-1) and total-body BMD were analysed pre- and post-intervention. Serum 25(OH)D concentrations increased from 51.1 ± 22.9 nmol/L (mean ± SD) to 78.9 ± 21.1 nmol/L in the active group (p < 0.001 vs. control). Serum PTH showed a significant treatment difference (p < 0.001) with a decline in the active group, and increase in the control group. Serum IGF-1 increased in the active group (p < 0.001 vs. control). Serum CTX showed a greater decline in the active group (p = 0.001 vs. control). There were no significant differences in serum OC or P1NP between groups during the intervention. Total body BMD showed a small (0.02 g/cm 2 ; ~ 2%) but significant increase in the active group after supplementation (p = 0.033 vs. control). Consuming a vitamin D, calcium and leucine-enriched whey protein supplement for 13 weeks improved 25(OH)D, suppressed PTH and had small but positive effects on BMD, indicative of improved bone health, in sarcopenic non-malnourished older adults.",2019,"Serum PTH showed a significant treatment difference (p < 0.001) with a decline in the active group, and increase in the control group.","['Participants (n 380', 'Sarcopenic Non-Malnourished Older Adults', 'malnourished older participants (≥', '65\xa0years) with sarcopenia [determined by Short Physical Performance Battery (SPPB; 0-12) scores between 4 and 9, and a low skeletal muscle mass index (SMI; skeletal muscle mass/BW\u2009×\u2009100', 'sarcopenic non-malnourished older adults']","['Whey Protein Nutritional Supplement', 'vitamin D, calcium and leucine-enriched whey protein supplement', 'Vitamin D, Calcium and Leucine-Enriched', 'vitamin D, calcium and leucine-enriched whey protein drink']","['Total body BMD', 'bone health', 'Serum IGF-1', 'serum OC or P1NP', 'bone mineral density (BMD) and bone strength', 'Serum PTH', 'BMD, indicative of improved bone health', 'Bone Health', 'Serum 25(OH)D concentrations', 'Serum 25-hydroxyvitamin D [25(OH)D], parathyroid hormone (PTH), biochemical markers of bone formation (osteocalcin; OC, procollagen type 1 amino-terminal propeptide; P1NP) and resorption (carboxy-terminal collagen crosslinks; CTX), insulin like growth factor 1 (IGF-1) and total-body BMD']","[{'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]",380.0,0.237198,"Serum PTH showed a significant treatment difference (p < 0.001) with a decline in the active group, and increase in the control group.","[{'ForeName': 'Tom R', 'Initials': 'TR', 'LastName': 'Hill', 'Affiliation': 'Institute of Cellular Medicine, Human Nutrition Research Centre, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK. Tom.hill@ncl.ac.uk.'}, {'ForeName': 'Sjors', 'Initials': 'S', 'LastName': 'Verlaan', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Uppsalalaan 12, Utrecht Science Park, Utrecht, 3584 CT, The Netherlands.'}, {'ForeName': 'Egbert', 'Initials': 'E', 'LastName': 'Biesheuvel', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Uppsalalaan 12, Utrecht Science Park, Utrecht, 3584 CT, The Netherlands.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Eastell', 'Affiliation': 'Academic Unit of Bone Metabolism, Metabolic Bone Centre, Northern General Hospital, University of Sheffield, Sheffield, S5 7AU, UK.'}, {'ForeName': 'Jürgen M', 'Initials': 'JM', 'LastName': 'Bauer', 'Affiliation': 'Department of Geriatric Medicine, Carl von Ossietzky University, Oldenburg, Germany.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Bautmans', 'Affiliation': 'Frailty in Ageing Research Group (FRIA), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Brandt', 'Affiliation': 'Institute of Cellular Medicine, Human Nutrition Research Centre, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Lorenzo M', 'Initials': 'LM', 'LastName': 'Donini', 'Affiliation': 'Department of Experimental Medicine, Section of Medical Pathophysiology, Endocrinology and Human Nutrition, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Maggio', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Geriatrics, University of Parma, Parma, Italy.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Mets', 'Affiliation': 'Frailty in Ageing Research Group (FRIA), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Seal', 'Affiliation': 'Institute of Cellular Medicine, Human Nutrition Research Centre, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Sander Lj', 'Initials': 'SL', 'LastName': 'Wijers', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Uppsalalaan 12, Utrecht Science Park, Utrecht, 3584 CT, The Netherlands.'}, {'ForeName': 'Cornel', 'Initials': 'C', 'LastName': 'Sieber', 'Affiliation': 'Institute for Biomedicine on Ageing, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cederholm', 'Affiliation': 'Department of Public Health and Caring Sciences/Clinical Nutrition and Metabolism, Department of Geriatric Medicine, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Terry J', 'Initials': 'TJ', 'LastName': 'Aspray', 'Affiliation': 'Bone Clinic, Institute of Cellular Medicine, Freeman Hospital, Newcastle University, Newcastle upon Tyne, NE7 7DE, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Calcified tissue international,['10.1007/s00223-019-00581-6']
572,31330457,"The effect of ultrasound-guided intercostal nerve block, single-injection erector spinae plane block and multiple-injection paravertebral block on postoperative analgesia in thoracoscopic surgery: A randomized, double-blinded, clinical trial.","STUDY OBJECTIVE
The study was to determine the analgesic effect of ultrasound-guided intercostal nerve block (ICNB) and single-injection erector spinae plane block (ESPB) in comparison with multiple-injection paravertebral block (PVB) after thoracoscopic surgery.
DESIGN
Randomized, controlled, double- blinded study.
SETTING
Operating room, postoperative recovery room and ward.
PATIENTS
Seventy-five patients, aged 18-75 years, ASA I-II and scheduled for elective thoracoscopic partial pulmonary resection surgery were enrolled in the study. Seventy-two patients were left for final analysis.
INTERVENTIONS
Patients were randomly assigned into the three groups (PVB group, ICNB group or ESPB group). After anesthesia induction, a single anesthesiologist performed PVB at T5-T7 levels or ICNB at T4-T9 levels or ESPB at T5 level under ultrasound guidance using 20 ml of 0.375% ropivacaine. Patients were connected to the patient-controlled morphine analgesia device after surgery.
MEASUREMENTS
Cumulative morphine consumption at 24 h postoperatively as primary outcome was compared. Visual analog scale pain scores at rest and while coughing at 0, 2, 4, 8, 24 and 48 h postoperatively, cumulative morphine consumption at other observed time and rescue analgesia requirement were also recorded.
MAIN RESULTS
There was a significant difference in median [interquartile range, IQR] morphine consumption at 24 h postoperatively among the three groups (PVB, 10.5 [9-15] mg; ICNB, 18 [13.5-22.1] mg; ESPB, 22 [15-25.1] mg; p = 0.000). This difference was statistically significant for PVB group vs ESPB group (median difference, -7.5; 95% confidence interval [CI], -12 to -4.5; p = 0.000) and PVB group vs ICNB group (median difference, -6; 95% CI, -9 to -3; p = 0.001), but not for ICNB vs ESPB (median difference, -3; 95% CI, -6 to 1.5; p = 0.192). PVB group had significantly lower VAS scores at rest and while coughing than ESPB group at 0, 2, 4, 8 h postoperatively and than ICNB group at 8 h postoperatively. There was no significant difference in the VAS scores between ICNB group and ESPB group at all time. Median VAS scores at rest and while coughing at all time were low (<4) in all groups. More rescue analgesia was needed in ESPB group during 48 postoperative hours (PVB vs ICNB vs ESPB; 13% vs 29% vs 46%; p < 0.05).
CONCLUSIONS
Ultrasound-guided multiple-injection PVB provided superior analgesia to ICNB and single-injection ESPB, while ICNB and single-injection ESPB were equally effective in reducing pain after thoracoscopic surgery.",2020,"PVB group had significantly lower VAS scores at rest and while coughing than ESPB group at 0, 2, 4, 8 h postoperatively and than ICNB group at 8 h postoperatively.","['thoracoscopic surgery', 'comparison with multiple-injection paravertebral block (PVB) after thoracoscopic surgery', 'Seventy-five patients, aged 18-75\u202fyears, ASA I-II and scheduled for elective thoracoscopic partial pulmonary resection surgery were enrolled in the study', 'Operating room, postoperative recovery room and ward']","['ultrasound-guided intercostal nerve block, single-injection erector spinae plane block and multiple-injection paravertebral block', 'PVB', 'ESPB', 'ropivacaine', 'ICNB', 'ultrasound-guided intercostal nerve block (ICNB) and single-injection erector spinae plane block (ESPB', 'ICNB group or ESPB']","['time and rescue analgesia requirement', 'pain', 'Median VAS scores', 'median [interquartile range, IQR] morphine consumption', 'Cumulative morphine consumption', 'Visual analog scale pain scores', 'VAS scores', 'cumulative morphine consumption', 'PVB at T5-T7 levels or ICNB at T4-T9 levels or ESPB', 'rescue analgesia']","[{'cui': 'C0751551', 'cui_str': 'Surgical Procedures, Thoracoscopic'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0196716', 'cui_str': 'Local anesthetic intercostal nerve block (procedure)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",75.0,0.33233,"PVB group had significantly lower VAS scores at rest and while coughing than ESPB group at 0, 2, 4, 8 h postoperatively and than ICNB group at 8 h postoperatively.","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Qiao', 'Affiliation': 'Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'RongMin', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'QiaoQiao', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: doc_zhang18@163.com.'}, {'ForeName': 'YuKe', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.07.002']
573,31313807,Impact of procedural multimedia instructions for pH BRAVO testing on patient comprehension: a prospective randomized study.,"The positive impact on patient comprehension and improved procedural outcomes when multimedia is utilized to convey instructions preprocedurally has been previously shown for gastrointestinal procedures such as colonoscopy. However, in gastroesophageal reflux testing (GERD), we continue to utilize verbal and written instructions to establish this diagnosis when we use BRAVO pH testing. This is arguably a more complex procedure involving stopping medications, placement of a device, and maintaining an accurate diary for the duration of the testing. We hypothesize that by utilizing multimedia to relay complex textual information, patients will have improved comprehension of periprocedural instructions thereby improving data entry and satisfaction of expectations during the procedure. Prospective randomized study of 120 patients undergoing endoscopic placement of the BRAVO pH monitoring capsule for evaluation of GERD receive either written preoperative instructions (control) or written plus video instructions (video group). A composite comprehension score was calculated using procedure-specific parameters of data entry over the 48-hour monitoring period. Patient satisfaction was evaluated on the basis of a five-point Likert scale. Extent of patient satisfaction was defined by the fulfillment of patient expectations. Exclusion criteria included patients who did not have access to the video or did not complete follow-up. Seventy-eight patients completed all follow-up evaluations. The video group (n = 44) had a significantly higher mean comprehension score when compared to the control group (n = 34) (9.6 ± 1.4 vs. 7.4 ± 2.0, P = 0.01). Overall satisfaction with instructions was significantly higher in the intervention group (91% vs. 47%, p 0.01). We detected no significant difference in comprehension or satisfaction scores in subgroup analyses of the video group comparing patients <65 and ≥65 years of age and by education level. Compared to standard written instructions, video instructions improved patient comprehension based on data evaluation, and satisfaction. Therefore, clinicians should consider incorporation of multimedia instructions to enhance patient periprocedural expectations and understanding of reflux pH testing using the BRAVO procedure.",2020,"Overall satisfaction with instructions was significantly higher in the intervention group (91% vs. 47%, p 0.01).","['120 patients undergoing endoscopic placement of the BRAVO pH monitoring capsule for evaluation of GERD receive either', 'Exclusion criteria included patients who did not have access to the video or did not complete follow-up', 'patient comprehension']","['procedural multimedia instructions for pH BRAVO testing', 'written preoperative instructions (control) or written plus video instructions (video group']","['Patient satisfaction', 'Overall satisfaction with instructions', 'patient comprehension based on data evaluation, and satisfaction', 'mean comprehension score', 'comprehension or satisfaction scores']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0443160', 'cui_str': 'Bravo (qualifier value)'}, {'cui': 'C4708610', 'cui_str': 'pH monitoring capsule'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0443160', 'cui_str': 'Bravo (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",120.0,0.0439485,"Overall satisfaction with instructions was significantly higher in the intervention group (91% vs. 47%, p 0.01).","[{'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Moore', 'Affiliation': 'Department of Surgery, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Gray', 'Affiliation': 'Department of Surgery, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Panjwani', 'Affiliation': 'Department of Surgery, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Finnerty', 'Affiliation': 'Department of Surgery, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ciecerega', 'Affiliation': 'Department of Surgery, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Afaneh', 'Affiliation': 'Department of Surgery, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Fahey', 'Affiliation': 'Department of Surgery, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'C V', 'Initials': 'CV', 'LastName': 'Crawford', 'Affiliation': 'Department of Surgery, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zarnegar', 'Affiliation': 'Department of Surgery, Weill Cornell Medical College, New York, New York, USA.'}]",Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus,['10.1093/dote/doz068']
574,31314661,A Randomized Clinical Trial Comparing the Impact of a Web-Based Multimedia Intervention Versus an Educational Pamphlet on Patient Outcomes in Breast Cancer Survivors with Chronic Secondary Lymphedema.,"Objective: The purpose of this study was to evaluate the effects of a Web-based Multimedia Intervention (WBMI) for breast cancer-related lymphedema (BCRL) patients on symptom burden, function, psychological well-being, costs, and arm volume. Methods: Women with BCRL were randomized to intervention ( n = 80) or control ( n = 80) groups. The WBMI offered 12 modules, each of which took about 30 minutes to complete. The Pamphlet took about 2 hours to read. Data on symptom burden, psychological well-being, function, and costs were collected preintervention; and 1, 3, 6, and 12 months postintervention. A subgroup of 45 regional patients had arm extracellular fluid measured by bioimpedance at baseline and at 3, 6, and 12 months postintervention. Intervention perceived value was also captured. Results: A statistically significant difference ( p = 0.011) was observed for rates of intervention completion, WBMI (58%), and Pamphlet (77%). With the exception of the number of biobehavioral symptoms (mood), no statistically significant differences between groups in symptom reduction were apparent between baseline and 1 or 12 months (effect sizes = 0.05-0.28, p > 0.05) based on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A). No statistically significant differences between the groups were observed for changes in other variables. The WBMI was perceived as providing better self-care information than the Pamphlet ( p = 0.001). Conclusions: WBMI participants experienced improved biobehavioral symptoms and higher perceived quality of information. The lack of significant differences on other variables may be due to the high percentage of participants who did not complete the WBMI.",2020,The WBMI was perceived as providing better self-care information than the Pamphlet ( p = 0.001). ,"['breast cancer-related lymphedema (BCRL) patients on', 'Women with BCRL', 'Breast Cancer Survivors with Chronic Secondary Lymphedema']","['Web-Based Multimedia Intervention', 'Web-based Multimedia Intervention (WBMI', 'Educational Pamphlet']","['number of biobehavioral symptoms (mood', 'Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A', 'symptom reduction', 'WBMI', 'biobehavioral symptoms and higher perceived quality of information', 'symptom burden, psychological well-being, function, and costs', 'rates of intervention completion, WBMI', 'symptom burden, function, psychological well-being, costs, and arm volume']","[{'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0265191', 'cui_str': 'Chronic acquired lymphedema (disorder)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",12.0,0.107559,The WBMI was perceived as providing better self-care information than the Pamphlet ( p = 0.001). ,"[{'ForeName': 'Sheila H', 'Initials': 'SH', 'LastName': 'Ridner', 'Affiliation': 'Center for Research Development and Scholarship, School of Nursing, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Dietrich', 'Affiliation': 'Center for Research Development and Scholarship, School of Nursing, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Davis', 'Affiliation': 'Center for Research Development and Scholarship, School of Nursing, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Vaughn', 'Initials': 'V', 'LastName': 'Sinclair', 'Affiliation': 'Center for Research Development and Scholarship, School of Nursing, Vanderbilt University, Nashville, Tennessee.'}]",Journal of women's health (2002),['10.1089/jwh.2019.7676']
575,31329246,Effect of a Community Health Worker-Delivered Parental Education and Counseling Intervention on Anemia Cure Rates in Rural Indian Children: A Pragmatic Cluster Randomized Clinical Trial.,"Importance
Iron deficiency anemia, the largest cause of anemia worldwide, adversely affects cognitive development in children. Moreover, the imperceptible childhood anemia prevalence reduction in response to anemia control measures is associated with tremendous social and economic cost.
Objective
To evaluate the effects of community-based parental education/counseling when combined with usual treatment on children's anemia cure rate.
Design, Setting, and Participants
A pragmatic cluster randomized clinical trial in children aged 12 to 59 months from 55 villages from the rural Chamrajnagar district in southern India was conducted between November 2014 and July 2015; 6-month follow-up ended in January 2016. Villages were randomly assigned to either usual treatment (n = 27) or to the intervention (n = 28). Among 1144 participating children, 534 were diagnosed as having anemia (hemoglobin levels <11g/dL and >7.9g/dL; to convert to grams per liter, multiply by 10) and constituted the study sample in this analysis. Data were analyzed between July 2016 and September 2017.
Interventions
Iron and folic acid (IFA), 20 mg/d, 5 times daily per week, for 5 months (usual treatment) or health worker-delivered education/counseling combined with usual treatment (intervention).
Main Outcomes and Measures
The primary outcome was anemia cure rate defined as hemoglobin level at or greater than 11 g/dL during follow-up.
Results
Of the children included in the study, the mean age was 30 months, with a slightly higher ratio of boys to girls. Of 534 children with anemia (intervention n = 303; usual treatment n = 231), 517 were reassessed after 6 months (intervention n = 298; usual treatment n = 219) while 17 were lost to follow-up (intervention n = 5 and usual treatment n = 12). Anemia cure rate was higher in children in the intervention group compared with children receiving usual treatment (55.7% [n = 166 of 298] vs 41.4% [n = 90 of 219]). The risk ratio derived through multilevel logistic regression was 1.37 (95% CI, 1.04-1.70); the model-estimated risk difference was 15.1% (95% CI, 3.9-26.3). Intervention-group children demonstrated larger mean hemoglobin increments (difference, intervention vs control: 0.25 g/dL; 95% CI, 0.07-0.44 g/dL) and improved IFA adherence (61.7%; 95% CI, 56.2-67.3 vs 48.4%; 95% CI, 41.7-55.1 consumed >75% of tablets provided). Adverse events were mild (intervention: 26.8%; 95% CI, 21.8-31.9 vs usual treatment: 21%; 95% CI, 15.6-26.4). To cure 1 child with anemia, 7 mothers needed to be counseled (number needed to treat: 7; 95% CI, 4-26).
Conclusions and Relevance
Parental education and counseling by a community health worker achieved perceivable gains in curing childhood anemia. Policy makers should consider this approach to enhance population level anemia control.
Trial Registration
ISRCTN identifier: ISRCTN68413407.",2019,"Adverse events were mild (intervention: 26.8%; 95% CI, 21.8-31.9 vs usual treatment: 21%; 95% CI, 15.6-26.4).","['children', 'children aged 12 to 59 months from 55 villages from the rural Chamrajnagar district in southern India was conducted between November 2014 and July 2015; 6-month follow-up ended in January 2016', '1144 participating children, 534 were diagnosed as having anemia (hemoglobin levels <11g/dL and ', '534 children with anemia (intervention n\u2009=\u2009303; usual treatment n\u2009=\u2009231), 517 were', 'Rural Indian Children']","['health worker-delivered education/counseling combined with usual treatment (intervention', 'reassessed after 6 months (intervention n\u2009=\u2009298; usual treatment n\u2009=\u2009219) while 17 were lost to follow-up (intervention n\u2009=\u20095 and usual treatment n\u2009=\u200912', 'community-based parental education/counseling', 'Community Health Worker-Delivered Parental Education and Counseling Intervention', 'Interventions\n\n\nIron and folic acid (IFA']","['Anemia Cure Rates', 'IFA adherence', ""children's anemia cure rate"", 'Adverse events', 'anemia cure rate defined as hemoglobin level', 'larger mean hemoglobin increments', 'Anemia cure rate', 'risk ratio derived through multilevel logistic regression']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0206031', 'cui_str': 'Logistic Regression'}]",534.0,0.181575,"Adverse events were mild (intervention: 26.8%; 95% CI, 21.8-31.9 vs usual treatment: 21%; 95% CI, 15.6-26.4).","[{'ForeName': 'Arun S', 'Initials': 'AS', 'LastName': 'Shet', 'Affiliation': 'Department of Hematology/Medical Oncology, St Johns Medical College and Hospital, Bangalore, India.'}, {'ForeName': 'Merrick', 'Initials': 'M', 'LastName': 'Zwarenstein', 'Affiliation': 'Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.'}, {'ForeName': 'Abha', 'Initials': 'A', 'LastName': 'Rao', 'Affiliation': 'Department of Hematology/Medical Oncology, St Johns Medical College and Hospital, Bangalore, India.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Jebaraj', 'Affiliation': 'Department of Hematology/Medical Oncology, St Johns Medical College and Hospital, Bangalore, India.'}, {'ForeName': 'Karthika', 'Initials': 'K', 'LastName': 'Arumugam', 'Affiliation': 'Department of Hematology/Medical Oncology, St Johns Medical College and Hospital, Bangalore, India.'}, {'ForeName': 'Salla', 'Initials': 'S', 'LastName': 'Atkins', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Mascarenhas', 'Affiliation': 'MYRADA, Bangalore, India.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Klar', 'Affiliation': 'Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Galanti', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.2087']
576,32199541,Randomized clinical trial of Cognitive Remediation Therapy with Work Therapy in the early phase of substance use disorder recovery for older Veterans: 12-Month follow-up.,"OBJECTIVE
In a previous report on a randomized clinical trial of a 3-month program of Cognitive Remediation Therapy (CRT) augmented by Work Therapy (WT) compared with WT alone for older veterans with substance use disorder (SUD), we reported significantly greater improvements at six-month follow-up on neurocognitive outcomes of working memory and executive functions for the CRT + WT condition. However, no difference was found between conditions on SUD outcomes, with both groups showing unusually high levels of abstinence. In this study, we extended follow-up to 12 months to test whether there was an SUD outcome ""sleeper effect"" from CRT + WT. To better understand the effects of WT, we added a treatment-as-usual (TAU) comparison sample.
METHOD
Forty-eight veterans with SUD receiving standard outpatient VA care were randomized into CRT + WT or WT. Clinical Global Impression (CGI) ratings were performed on 43/48 participants with up-to-date medical records. A TAU comparison group (n = 44) with similar demographic and illness characteristics was added to the analysis.
RESULTS
Treatment groups did not differ significantly at 12 months on CGI (p = 0.27), with 77% receiving CRT + WT showing favorable SUD outcomes compared to 62% in WT. Both groups had better CGI outcomes (p < 0.01) compared to the TAU comparison group (27%). Hours of WT participation (r = -0.49, p = 0.001) and hours of CRT (r = -0.45, p = 0.048) were associated with better CGI scores.
CONCLUSION
While no sleeper effect was found for CRT, a robust effect was strongly supported for WT on SUD outcomes.",2020,", we reported significantly greater improvements at six-month follow-up on neurocognitive outcomes of working memory and executive functions for the CRT + WT condition.","['43/48 participants with up-to-date medical records', 'older Veterans', 'older veterans with substance use disorder (SUD', 'Forty-eight veterans with SUD receiving standard outpatient VA care']","['CRT\xa0+\xa0WT or WT', 'WT alone', 'Cognitive Remediation Therapy with Work Therapy', 'Cognitive Remediation Therapy (CRT) augmented by Work Therapy (WT']","['CGI scores', 'CGI', 'neurocognitive outcomes of working memory and executive functions', 'CGI outcomes', 'Clinical Global Impression (CGI) ratings']","[{'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0025102', 'cui_str': 'Medical Records'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.0473496,", we reported significantly greater improvements at six-month follow-up on neurocognitive outcomes of working memory and executive functions for the CRT + WT condition.","[{'ForeName': 'Morris D', 'Initials': 'MD', 'LastName': 'Bell', 'Affiliation': 'Department of Psychiatry, Yale University, VA Connecticut Healthcare System, United States of America. Electronic address: Morris.bell@yale.edu.'}, {'ForeName': 'Bharath', 'Initials': 'B', 'LastName': 'Muppala', 'Affiliation': 'Department of Psychiatry, Yale University, United States of America.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Weinstein', 'Affiliation': 'Department of Psychiatry, Yale University, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ciosek', 'Affiliation': 'VA Connecticut Healthcare System, United States of America.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale University, United States of America.'}, {'ForeName': 'Ismene', 'Initials': 'I', 'LastName': 'Petrakis', 'Affiliation': 'Department of Psychiatry, Yale University, VA Connecticut Healthcare System, United States of America.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Fiszdon', 'Affiliation': 'Department of Psychiatry, Yale University, VA Connecticut Healthcare System, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.01.018']
577,31290550,Long-Term Smoking Cessation Outcomes for Sexual Minority Versus Nonminority Smokers in a Large Randomized Controlled Trial of Two Web-Based Interventions.,"INTRODUCTION
Despite greater smoking prevalence among sexual minority (SM) individuals relative to non-SM individuals, minimal research has examined whether SM smokers have differential success at quitting, and no prior treatment studies have examined differences within SM subgroups. There is also limited knowledge of the psychosocial characteristics of treatment-seeking SM smokers, which could inform targeted treatments. To address these gaps, we compared treatment outcomes and baseline characteristics for SM and non-SM smokers and for bisexual versus lesbian or gay smokers in a large randomized controlled trial of two web-based cessation treatments.
METHODS
Trial participants completed a survey to assess baseline characteristics, including self-identification as either SM (n = 253; lesbian or gay, n = 122; bisexual, n = 131) or non-SM (n = 2384). The primary cessation outcome was complete-case, self-reported 30-day abstinence at 12 months after randomization.
RESULTS
Cessation outcomes did not differ significantly for SM versus non-SM smokers (24% vs. 25%, adjusted OR = 0.91, 95% CI = 0.65 to 1.28) or across SM subgroups (24% for bisexual vs. 23% for lesbian or gay, adjusted OR = 1.01, 95% CI = 0.51 to 2.00), and there were no interactions with treatment group assignment. At baseline, SM smokers differed from non-SM smokers on most demographics, were more likely to screen positive for all mental health conditions assessed, and had greater exposure to other smokers in the home.
CONCLUSIONS
Substantial differences in baseline characteristics of SM versus non-SM smokers and bisexual versus lesbian or gay smokers did not translate into differential treatment outcomes. Nonetheless, SM smokers' willingness or ability to quit smoking could be enhanced by taking their unique psychosocial profile into account when designing targeted interventions.
IMPLICATIONS
The findings of this study, which included the largest sample of SM smokers in a prospective intervention trial to date, support those of a small extant body of literature showing no differences in treatment-assisted cessation outcomes between SM and non-SM smokers. Regardless of their quit rates relative to non-SM smokers, SM smokers' willingness or ability to quit smoking could potentially be enhanced by taking their unique psychosocial profile into account in intervention design, including their younger age, lower socioeconomic status, greater likelihood of being racial or ethnic minorities, and greater prevalence of mental health symptoms.",2020,"At baseline, SM smokers differed from non-SM smokers on most demographics, were more likely to screen positive for all mental health conditions assessed, and had greater exposure to other smokers in the home.
","['sexual minority (SM) and non-SM smokers', 'Trial participants completed a survey to assess baseline characteristics, including self-identification as either SM (n=253; lesbian/gay, n=122; bisexual, n=131) or non-SM (n=2,384', 'sexual minority vs. non-minority smokers']",[],['complete-case self-reported 30-day abstinence'],"[{'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C1533642', 'cui_str': 'Women Who Have Sex With Women'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C2129310', 'cui_str': 'Bisexual (finding)'}]",[],"[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.0278065,"At baseline, SM smokers differed from non-SM smokers on most demographics, were more likely to screen positive for all mental health conditions assessed, and had greater exposure to other smokers in the home.
","[{'ForeName': 'Jaimee L', 'Initials': 'JL', 'LastName': 'Heffner', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Mull', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Noreen L', 'Initials': 'NL', 'LastName': 'Watson', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'McClure', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute (formerly Group Health Research Institute), Seattle, WA.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Bricker', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz112']
578,31298194,"Fetal Repair of Open Neural Tube Defects: Ethical, Legal, and Social Issues.","Open neural tube defects or myelomeningoceles are a common congenital condition caused by failure of closure of the neural tube early in gestation, leading to a number of neurologic sequelae including paralysis, hindbrain herniation, hydrocephalus and neurogenic bowel and bladder dysfunction. Traditionally, the condition was treated by closure of the defect postnatally but a recently completed randomized controlled trial of prenatal versus postnatal closure demonstrated improved neurologic outcomes in the prenatal closure group. Fetal surgery, or more precisely maternal-fetal surgery, raises a number of ethical issues that we address including who the patient is, informed consent, surgical innovation and equipoise as well maternal assumption of risk. As the procedure becomes more widely adopted into practice, we suggest close monitoring of new fetal surgery centers, in order to ensure that the positive results of the trial are maintained without increased risk to both the mother and fetus.",2019,"Open neural tube defects or myelomeningoceles are a common congenital condition caused by failure of closure of the neural tube early in gestation, leading to a number of neurologic sequelae including paralysis, hindbrain herniation, hydrocephalus and neurogenic bowel and bladder dysfunction.",[],[],['neurologic outcomes'],[],[],"[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",,0.041154,"Open neural tube defects or myelomeningoceles are a common congenital condition caused by failure of closure of the neural tube early in gestation, leading to a number of neurologic sequelae including paralysis, hindbrain herniation, hydrocephalus and neurogenic bowel and bladder dysfunction.","[{'ForeName': 'Julia A E', 'Initials': 'JAE', 'LastName': 'Radic', 'Affiliation': ''}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Illes', 'Affiliation': ''}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McDonald', 'Affiliation': ''}]",Cambridge quarterly of healthcare ethics : CQ : the international journal of healthcare ethics committees,['10.1017/S0963180119000409']
579,31297576,Micro-fragmented stromal-vascular fraction plus microfractures provides better clinical results than microfractures alone in symptomatic focal chondral lesions of the knee.,"PURPOSE
To evaluate clinical outcomes over a 1-year period in patients affected by symptomatic focal chondral lesions of the knee treated with micro-fragmented stromal-vascular fraction plus microfractures compared to microfractures alone.
METHODS
Two groups of 20 patients were arthroscopically treated with microfractures for a symptomatic focal chondral defect of the knee. At the end of surgery, in the experimental group, micro-fragmented stromal-vascular fraction was injected into the joint. Primary end point was WOMAC score at 12 months. Secondary end points were any adverse events, Oxford Knee Score, EQ-5D score, VAS for pain, analgesic and anti-inflammatory consumption.
RESULTS
All the patients were evaluated at 12-month follow-up. No adverse reactions were noted. Analgesic and anti-inflammatory consumption was similar in both groups. At 1-month follow-up, no differences were noted between groups when compared to pre-operative scores. At 3-month follow-up, patients in both groups improved from the baseline in all variables. Significantly lower VAS scores were found in the experimental group (4.2 ± 3.2 vs. 5.9 ± 1.7, p = 0.04). At 6- and 12-month follow-ups, patients in the experimental group scored better in all outcomes with a moderate effect size; in particular, better WOMAC scores were obtained at 12 months, achieving the primary end-point of the study (17.7 ± 11.1 vs. 25.5 ± 12.7; p = 0.03).
CONCLUSIONS
Injection of micro-fragmented stromal-vascular fraction is safe and, when associated with microfractures, is more effective in clinical terms than microfractures alone in patients affected by symptomatic focal chondral lesions of the knee. Results of the current study provide information that could help physicians to improve their counseling for patients concerning ADMSCs.
LEVEL OF EVIDENCE
Level 1-therapeutic study.",2020,"At 6- and 12-month follow-ups, patients in the experimental group scored better in all outcomes with a moderate effect size; in particular, better WOMAC scores were obtained at 12 months, achieving the primary end-point of the study (17.7 ± 11.1 vs. 25.5 ± 12.7; p = 0.03).
","['Two groups of 20 patients were arthroscopically treated with microfractures for a symptomatic focal chondral defect of the knee', 'patients affected by symptomatic focal chondral lesions of the knee treated with micro-fragmented stromal-vascular fraction plus microfractures compared to microfractures alone']",[],"['WOMAC score', 'VAS scores', 'Analgesic and anti-inflammatory consumption', 'adverse events, Oxford Knee Score, EQ-5D score, VAS for pain, analgesic and anti-inflammatory consumption', 'adverse reactions', 'WOMAC scores']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1265651', 'cui_str': 'Micro Fractures'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0410334', 'cui_str': 'Defect of articular cartilage (disorder)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}, {'cui': 'C0442012', 'cui_str': 'Chondral (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",,0.0553153,"At 6- and 12-month follow-ups, patients in the experimental group scored better in all outcomes with a moderate effect size; in particular, better WOMAC scores were obtained at 12 months, achieving the primary end-point of the study (17.7 ± 11.1 vs. 25.5 ± 12.7; p = 0.03).
","[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Bisicchia', 'Affiliation': 'Applied Biotechnologies and Translational Medicine, University of Rome Tor Vergata, Via Montpellier 1, 00133, Rome, Italy. s.bisicchia@gmail.com.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Bernardi', 'Affiliation': 'Department of Orthopaedic Surgery, Sports Traumatology Unit, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.'}, {'ForeName': 'Susanna M', 'Initials': 'SM', 'LastName': 'Pagnotta', 'Affiliation': 'Department of Orthopaedic Surgery, Sports Traumatology Unit, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Tudisco', 'Affiliation': 'Department of Orthopaedic Surgery, Sports Traumatology Unit, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05621-0']
580,31259802,Improved Reduction of the Tibio-Fibular Syndesmosis with Tightrope compared to Screw Fixation: Results of a Randomized Controlled Study.,"OBJECTIVE
To compare the rate of malreduction following high fibular fractures associated with syndesmosis injury treated with open reduction and internal fixation, with either two screws or one knotless Tightrope device.
DESIGN
Prospective randomized controlled multicenter trial SETTING:: Eleven academic and community hospitals including level 1 and 2 trauma centers across CanadaPatients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability following malleolar bony fixation were followed for 12 months after treatment.
METHODS
Open reduction of the syndesmosis was performed in all cases. Fixation was randomized to either Tightrope (one knotless Tightrope, Group T) or screw fixation (two 3.5 mm cortical positional screws placed across 3 cortices, Group S). Surgical techniques and rehabilitation were standardized. All surgeons were trained or experienced in the use of the Tightrope device. Follow up was performed at 2 and 6 weeks, 3, 6 and 12 months.
MAIN OUTCOME MEASURE
Rate of malreduction based on bilateral ankle CT scan results at 3 months post fixation. Secondary outcome measures included adverse events, reoperation, and validated functional outcomes including the EQ5D, the Olerud-Molander Ankle Score (OM), the Foot and Ankle Disability Index (FADI), and the Work Productivity Activity Impairment Questionnaire (WPAI). The estimated sample size required to detect a difference in reduction rate was 72 patients, but the estimated sample size required to detect a difference in functional outcome scores was 240 patients, suggesting the study was adequately powered for radiographic results only.
RESULTS
Overall, the rate of malreduction using screw fixation was 39 % compared with 15 % using Tightrope fixation (p = 0.028, Chi square). Analysis of CT results was performed using a 2 mm translation or 10 degree rotation threshold for malreduction, and included fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, mid); medial compression; and rotation (fibular and articular). Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05). Group T syndesmoses also had greater diastasis compared to control limb (4.1 ± 1.3 vs 3.3 ± 1.4 mm, p<0.01) and less fibular medialization compared to Group S (1.04 ± 1.8 vs 0.3± 1.8 mm, p = 0.05). Functional outcome measures demonstrated significant improvements over time, but no differences between fixation groups. FADI scores at each time interval were: 44 ± 22 (T) vs 45 ± 24 (S) (6 weeks), 76 ± 14 vs 73 ± 17 (3 months), 89 ± 10 vs 86 ± 13 (6 months), and 93 ± 9 vs 90 ± 14 (12 months) (all p > 0.2). The reoperation rate was higher in the screw group compared to Tightrope (30% vs 4%, p= 0.02) with the difference driven by the rate of implant removal.
CONCLUSION
Based upon our results the Tightrope device appears to compare favorably to two, 3.5 mm, 3- cortex screw fixation for syndesmosis injuries.",2019,"Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05).","[' Eleven academic and community hospitals including level 1 and 2 trauma centers across CanadaPatients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability following malleolar bony fixation were followed for 12 months after treatment', 'syndesmosis injuries']","['Tightrope (one knotless Tightrope, Group T) or screw fixation', 'syndesmosis injury treated with open reduction and internal fixation, with either two screws or one knotless Tightrope device', 'Screw Fixation', '3- cortex screw fixation']","['rate of malreduction using screw fixation', 'Rate of malreduction based on bilateral ankle CT scan results at 3 months post fixation', 'greater anterior translation', 'fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, mid); medial compression; and rotation (fibular and articular', 'FADI scores', 'reoperation rate', 'adverse events, reoperation, and validated functional outcomes including the EQ5D, the Olerud-Molander Ankle Score (OM), the Foot and Ankle Disability Index (FADI), and the Work Productivity Activity Impairment Questionnaire (WPAI', 'rate of implant removal', 'fibular medialization']","[{'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0036679', 'cui_str': 'Separation (morphologic abnormality)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443157', 'cui_str': 'Bony (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0561946', 'cui_str': 'Removal of implant (procedure)'}]",103.0,0.107881,"Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-324, London, Ontario CANADA N6A 4G5 Tel: 519-685-8086 Fax: 519-685-8019.'}, {'ForeName': 'Prism', 'Initials': 'P', 'LastName': 'Schneider', 'Affiliation': 'Foothills Medical Centre McCaig Tower, 3134 Hospital Drive NW, Calgary, Alberta CANADA T2N 5A1 Tel: (403) 944-4518 Fax: (403) 270-8004.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-324, London, Ontario CANADA N6A 4G5 Tel: 519-685-8086 Fax: 519-685-8019.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tieszer', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-414London, Ontario CANADA N6A 4G5 Tel: 519-685-8500 x 55362 Fax: 519-685-8059.'}, {'ForeName': 'Abdel-Rahman', 'Initials': 'AR', 'LastName': 'Lawendy', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-325, London, Ontario CANADA N6A 4G5 Tel: 519-685-8218 Fax: 519-685-8059 800 Commissioners Road East, Room E1-326 London, Ontario CANADA N6A 4G5 Tel: (519) 685-8086 Fax: (519) 685-8016 Email: david.sanders@lhsc.on.ca.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001559']
581,31838180,Efficacy and safety of indigo naturalis ointment in Treating Atopic Dermatitis: A randomized clinical trial.,"ETHNOPHARMACOLOGICAL RELEVANCE
Indigo naturalis, a herbal medicine with a history of use dating back to ancient times, may be a good alternative topical treatment for atopic dermatitis (AD).
AIM OF THE STUDY
To provide empirical evidence of the efficacy and safety of Indigo naturalis ointment in treating AD.
MATERIALS AND METHODS
In this randomized double-blind clinical trial, participants aged 6 to 65 years with AD affecting less than 40% of their body surface area (BSA) and an Investigator's Global Assessment (IGA) score of 2 to 4 were randomized (2:1) to receive either Lindioil ointment or a vehicle ointment twice daily for 6 weeks. The primary endpoint was the percentage change in the Eczema Area Severity Index (EASI) from baseline to week 6. Secondary endpoints were as follows: EASI improvement ≥50%, 75%, and 90%; IGA score; BSA affected by AD; pruritus severity; and Dermatology Life Quality Index. The safety assessment included adverse events (AEs), laboratory tests, and physical examinations.
RESULTS
The Lindioil group (32 participants) and vehicle group (16 participants) achieved mean percentage EASI reductions of 49.9% ± 36.5% (95% CI 36.8%-63.1%) and 19.6% ± 52.2% (95% CI -8.2%-47.4%), respectively (P = 0.0235). The Lindioil group also showed greater improvement in every secondary assessment category. No significant AEs occurred.
CONCLUSION
Indigo naturalis ointment is effective for treating mild to severe AD topically, and appears to be safe. This is the first clinical trial to provide evidence supporting topical indigo-based AD treatment. ClinicalTrials.gov identifier: NCT02669888.",2020,"No significant AEs occurred.
","['Treating Atopic Dermatitis', ""participants aged 6 to 65 years with AD affecting less than 40% of their body surface area (BSA) and an Investigator's Global Assessment (IGA) score of 2 to 4""]","['indigo naturalis ointment', 'Lindioil ointment']","['mean percentage EASI reductions', 'Efficacy and safety', 'adverse events (AEs), laboratory tests, and physical examinations', 'IGA score; BSA affected by AD; pruritus severity; and Dermatology Life Quality Index', 'percentage change in the Eczema Area Severity Index (EASI']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C3489715', 'cui_str': 'indigo naturalis ointment'}, {'cui': 'C0028912', 'cui_str': 'Salves'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",32.0,0.47236,"No significant AEs occurred.
","[{'ForeName': 'Yin-Ku', 'Initials': 'YK', 'LastName': 'Lin', 'Affiliation': 'Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Keelung, 222, Maijin Road, Keelung, 20401, Taiwan; School of Traditional Chinese Medicine, College of Medicine, Chang Gung University, 259, Wenhua 1st Rd, Guishan Dist, Taoyuan, 33302, Taiwan. Electronic address: lin1266@cgmh.org.tw.'}, {'ForeName': 'Shu-Han', 'Initials': 'SH', 'LastName': 'Chang', 'Affiliation': 'Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Keelung, 222, Maijin Road, Keelung, 20401, Taiwan. Electronic address: B9605005@cgmh.org.tw.'}, {'ForeName': 'Chin-Yi', 'Initials': 'CY', 'LastName': 'Yang', 'Affiliation': 'Department of Dermatology, Chang Gung Memorial Hospital, Linkou, 5, Fuxing St, Guishan Dist, Taoyuan, 33305, Taiwan. Electronic address: sophiachinyi@cgmh.org.tw.'}, {'ForeName': 'Lai-Chu', 'Initials': 'LC', 'LastName': 'See', 'Affiliation': 'Department of Public Health, And Biostatistics Core Laboratory, Molecular Medicine Research Center, Chang Gung University, 259, Wenhua 1st Rd, Guishan Dist, Taoyuan, 33302, Taiwan; Department of Rheumatology and Allergy and Immunology, Chang Gung Memorial Hospital, Linkou, 5, Fuxing St, Guishan, Dist, Taoyuan, 33305, Taiwan. Electronic address: lichu@mail.cgu.edu.tw.'}, {'ForeName': 'Be-Han', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Keelung, 222, Maijin Road, Keelung, 20401, Taiwan. Electronic address: abbylee@cgmh.org.tw.'}, {'ForeName': 'I-Hsin', 'Initials': 'IH', 'LastName': 'Shih', 'Affiliation': 'Department of Dermatology, Chang Gung Memorial Hospital, Taipei, 199, Dunhua N. Rd, Taipei, 10507, Taiwan. Electronic address: ma1606@cgmh.org.tw.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2019.112477']
582,31272205,Exercise-based cardiac rehabilitation for patients with catheter ablation for persistent atrial fibrillation: A randomized controlled clinical trial.,"AIMS
The efficacy and safety of cardiac rehabilitation for patients with persistent atrial fibrillation who restored sinus rhythm after catheter ablation remains unclear. The aim of the present study was to evaluate the effects of cardiac rehabilitation on exercise capacity, inflammatory status, cardiac function, and safety in patients with persistent atrial fibrillation who had catheter ablation.
METHODS
In this randomized controlled study, 61 patients treated with catheter ablation for persistent atrial fibrillation (male, 80%; mean age, 66 ± 9 years) were analyzed. Thirty patients underwent cardiac rehabilitation (rehabilitation group), whereas the remaining 31 patients received usual care (usual care group). The rehabilitation group underwent endurance and resistance training with moderate intensity, at least three times per week for six months. Six-minute walk distance, muscle strength, serum high-sensitivity C-reactive protein, plasma pentraxin 3, left ventricular ejection fraction and atrial fibrillation recurrence were assessed at baseline and at six-month follow-up.
RESULTS
In the rehabilitation group, significant increases in the six-minute walk distance, handgrip strength, leg strength and left ventricular ejection fraction and significant decreases in high-sensitivity C-reactive protein and plasma pentraxin 3 concentrations were observed at six-month follow-up compared with baseline (all p < 0.05). No significant changes were observed in the usual care group. During the six-month follow-up period, the number of patients with atrial fibrillation recurrence was six (21.4%) in the rehabilitation group and eight (25.8%) in the usual care group (risk ratio, 0.83; 95% confidence interval, 0.33 to 2.10).
CONCLUSIONS
Cardiac rehabilitation improved exercise capacity without increasing the risk for atrial fibrillation recurrence. It may also be effective in managing systemic inflammatory status and systolic left ventricular function in patients with persistent atrial fibrillation treated with catheter ablation.",2019,"In the rehabilitation group, significant increases in the six-minute walk distance, handgrip strength, leg strength and left ventricular ejection fraction and significant decreases in high-sensitivity C-reactive protein and plasma pentraxin 3 concentrations were observed at six-month follow-up compared with baseline (all p < 0.05).","['Thirty patients underwent', 'patients with persistent atrial fibrillation who restored sinus rhythm after catheter ablation remains unclear', '61 patients treated with catheter ablation for persistent atrial fibrillation (male, 80%; mean age, 66\u2009±\u20099 years', 'patients with persistent atrial fibrillation treated with catheter ablation', 'patients with catheter ablation for persistent atrial fibrillation', 'patients with persistent atrial fibrillation who had catheter ablation']","['Exercise-based cardiac rehabilitation', 'cardiac rehabilitation', 'endurance and resistance training', 'usual care (usual care group', 'cardiac rehabilitation (rehabilitation group']","['six-minute walk distance, handgrip strength, leg strength and left ventricular ejection fraction', 'number of patients with atrial fibrillation recurrence', 'exercise capacity, inflammatory status, cardiac function, and safety', 'high-sensitivity C-reactive protein and plasma pentraxin 3 concentrations', 'Six-minute walk distance, muscle strength, serum high-sensitivity C-reactive protein, plasma pentraxin 3, left ventricular ejection fraction and atrial fibrillation recurrence', 'exercise capacity', 'efficacy and safety']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0174234', 'cui_str': 'TNF-stimulated gene 14'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",30.0,0.0470276,"In the rehabilitation group, significant increases in the six-minute walk distance, handgrip strength, leg strength and left ventricular ejection fraction and significant decreases in high-sensitivity C-reactive protein and plasma pentraxin 3 concentrations were observed at six-month follow-up compared with baseline (all p < 0.05).","[{'ForeName': 'Michitaka', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Department of Shizuoka Physical Therapy, Faculty of Health Science, Tokoha University, Shizuoka, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Ogano', 'Affiliation': 'Department of Cardiovascular Medicine, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Mori', 'Affiliation': 'Department of Rehabilitation, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Kaito', 'Initials': 'K', 'LastName': 'Kochi', 'Affiliation': 'Department of Rehabilitation, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Morimoto', 'Affiliation': 'Department of Rehabilitation, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Kito', 'Affiliation': 'Department of Rehabilitation, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Fumi Nihei', 'Initials': 'FN', 'LastName': 'Green', 'Affiliation': 'Anti-aging Center, Ginza Hospital, Tokyo, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Tsukamoto', 'Affiliation': 'Department of Shizuoka Physical Therapy, Faculty of Health Science, Tokoha University, Shizuoka, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kubo', 'Affiliation': 'Department of Shizuoka Physical Therapy, Faculty of Health Science, Tokoha University, Shizuoka, Japan.'}, {'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Takagi', 'Affiliation': 'Department of Cardiovascular Surgery, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tanabe', 'Affiliation': 'Department of Cardiovascular Medicine, Shizuoka Medical Center, Shizuoka, Japan.'}]",European journal of preventive cardiology,['10.1177/2047487319859974']
583,31125055,"A Phase 2 Study Evaluating the Safety, Tolerability, and Immunogenicity of Two 3-Dose Regimens of a Clostridium difficile Vaccine in Healthy US Adults Aged 65 to 85 Years.","BACKGROUND
Clostridium difficile causes toxin-mediated nosocomial diarrhea and community-acquired infections; no preventive vaccine is licensed. In this phase 2 study, we explored safety, tolerability, and immunogenicity in older US adults of an investigational bivalent C. difficile vaccine that contains equal dosages of genetically and chemically detoxified toxins A and B.
METHODS
Conducted from July 2015 through March 2017, 855 healthy adults aged 65-85 years from 15 US centers were randomized 3:3:1 to receive vaccine (100 or 200 μg) or placebo at 0, 1, and 6 months (month regimen) or 1, 8, and 30 days (day regimen). Serum toxin A- and B-specific neutralizing antibodies were measured. Participant-reported local reactions (LRs) and systemic events (SEs), adverse events (AEs), serious AEs, newly diagnosed chronic medical conditions, and immediate AEs were recorded.
RESULTS
The 200-μg dose level elicited higher immune responses than the 100-µg dose level across regimens. Compared with the day regimen, the month regimen induced stronger and more persistent immune responses that remained elevated 12 months after dose 3. Responses peaked at month 7 (month regimen) and day 37 (day regimen). LRs (primarily injection site pain) were more frequent in vaccine recipients than controls; SE frequency was similar across groups. More related AEs were reported in the day regimen group than the month regimen group.
CONCLUSIONS
The C. difficile vaccine was safe, well tolerated, and immunogenic in healthy US adults aged 65-85 years. Immune responses were particularly robust in the 200-μg month regimen group. These results support continued vaccine development.
CLINICAL TRIALS REGISTRATION
NCT02561195.",2020,LRs (primarily injection site pain) were more frequent in vaccine recipients than controls; SE frequency was similar across groups.,"['healthy US adults aged 65-85 years', 'Conducted from July 2015 through March 2017, 855 healthy adults aged 65-85 years from 15 US centers', 'older US adults', 'Aged 65 to 85 Years', 'Healthy US Adults']","['placebo', 'vaccine', 'Clostridium difficile Vaccine']","['Immune responses', 'Safety, Tolerability, and Immunogenicity', 'persistent immune responses', 'LRs (primarily injection site pain', 'Serum toxin A- and B-specific neutralizing antibodies', 'safe, well tolerated, and immunogenic', 'local reactions (LRs) and systemic events (SEs), adverse events (AEs), serious AEs, newly diagnosed chronic medical conditions, and immediate AEs', 'safety, tolerability, and immunogenicity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}]","[{'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0076851', 'cui_str': 'toxin A (Pseudomonas)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]",855.0,0.214698,LRs (primarily injection site pain) were more frequent in vaccine recipients than controls; SE frequency was similar across groups.,"[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kitchin', 'Affiliation': 'Pfizer Vaccine Clinical Research & Development, Hurley, United Kingdom.'}, {'ForeName': 'Shon A', 'Initials': 'SA', 'LastName': 'Remich', 'Affiliation': 'Pfizer Vaccine Research & Development, Collegeville, Pennsylvania.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peterson', 'Affiliation': 'Foothill Family Clinic, Salt Lake City, Utah.'}, {'ForeName': 'Yahong', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Pfizer Vaccine Research & Development, Collegeville, Pennsylvania.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': 'Pfizer Vaccine Research & Development, Pearl River, New York.'}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': 'Pfizer Vaccine Research & Development, Pearl River, New York.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Pride', 'Affiliation': 'Pfizer Vaccine Research & Development, Pearl River, New York.'}, {'ForeName': 'Annaliesa S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Pfizer Vaccine Research & Development, Pearl River, New York.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Knirsch', 'Affiliation': 'Pfizer Vaccine Research & Development, Pearl River, New York.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Webber', 'Affiliation': 'Pfizer Vaccine Clinical Research & Development, Hurley, United Kingdom.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz153']
584,31838589,Personal Approach to Treatment Choices for HIV (PATCH): Randomized Controlled Trial of a Brief Motivational Enhancement Intervention to Improve Medication Adherence in Persons with HIV.,"This pilot randomized controlled trial evaluated the feasibility and efficacy of a brief motivational enhancement intervention to improve adherence to antiretroviral therapy in persons with HIV called Personal Approach to Treatment Choices for HIV (PATCH). We compared PATCH to an active control condition on self-reported adherence, clinical outcomes, and psychosocial outcomes. Participants were 34 individuals (61.8% male, M age = 47.1) receiving HIV-related services who were suboptimally engaged in care. Participants completed baseline measures, participated in either PATCH or a stress reduction skills control intervention, and completed post-treatment and 3-month follow-up assessments. Results revealed no differences between conditions on adherence or clinical outcomes. At post-treatment, PATCH participants reported greater improvements in alcohol use, psychiatric symptoms, subjective mental functioning, and emotion-focused coping; improvements in subjective mental functioning were maintained at 3-months. Results suggest that motivational enhancement interventions can improve psychosocial outcomes for people with HIV. That some improvements were not maintained at follow-up suggests that effects wane over time and longer treatment may be indicated for lasting effects.",2020,"At post-treatment, PATCH participants reported greater improvements in alcohol use, psychiatric symptoms, subjective mental functioning, and emotion-focused coping; improvements in subjective mental functioning were maintained at 3-months.","['people with HIV', 'HIV (PATCH', 'Persons with HIV', 'Participants were 34 individuals (61.8% male, M age \u2009=\u200947.1) receiving HIV-related services who were suboptimally engaged in care', 'persons with HIV called Personal Approach to Treatment Choices for HIV (PATCH']","['motivational enhancement intervention', 'Motivational Enhancement Intervention', 'motivational enhancement interventions', 'PATCH or a stress reduction skills control intervention, and completed post-treatment and 3-month follow-up assessments']","['psychosocial outcomes', 'Medication Adherence', 'alcohol use, psychiatric symptoms, subjective mental functioning, and emotion-focused coping; improvements in subjective mental functioning']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]",34.0,0.0572077,"At post-treatment, PATCH participants reported greater improvements in alcohol use, psychiatric symptoms, subjective mental functioning, and emotion-focused coping; improvements in subjective mental functioning were maintained at 3-months.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Scharer', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Arnold', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wald', 'Affiliation': 'Minds in Focus Psychological Services, Baltimore, MD, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Nichols', 'Affiliation': 'Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Medoff', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Himelhoch', 'Affiliation': 'Department of Psychiatry, University of Kentucky College of Medicine, Lexington, KY, USA.'}, {'ForeName': 'Melanie E', 'Initials': 'ME', 'LastName': 'Bennett', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA. mbennett@som.umaryland.edu.'}]",AIDS and behavior,['10.1007/s10461-019-02759-3']
585,31823111,"The Feasibility, Acceptability and Preliminary Impact of Mobile Application to Increase Repeat HIV Testing Among Sexual Minority Men.","We pilot tested the Status Update Project (SUP) mobile app intervention to promote repeat HIV testing among HIV-negative US MSM. Participants (Mean age = 29 years; 51% racial/ethnic minority; 63% single) who were eligible and enrolled were randomized to either the SUP mobile app or a no-treatment condition, with assessments at baseline and month 4 and 8. Eighty-three percent of men were retained at the 8-month follow up. Among men randomized to the SUP arm, the app's ease and simplicity, health information, HIV testing locator, and HIV test reminders were most liked. At month 4, men randomized to the SUP arm were more likely to be repeat testers compared to those in the control arm (RR = 4.4; 95% CI 0.9, 19.9), although differences diminished by month 8 (RR = 1.2; 95% CI 0.8, 2.0). These findings add to our understanding of how mHealth interventions may play an important role in encouraging repeat HIV testing among MSM.",2020,"Among men randomized to the SUP arm, the app's ease and simplicity, health information, HIV testing locator, and HIV test reminders were most liked.","['Sexual Minority Men', 'Eighty-three percent of men were retained at the 8-month follow up', '29\xa0years; 51% racial/ethnic minority; 63% single) who were eligible and enrolled', 'Participants (Mean age\u2009']","['SUP', 'Mobile Application', 'SUP mobile app or a no-treatment condition', 'Status Update Project (SUP) mobile app intervention']",[],"[{'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0374778,"Among men randomized to the SUP arm, the app's ease and simplicity, health information, HIV testing locator, and HIV test reminders were most liked.","[{'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Horvath', 'Affiliation': 'SDSU/UCSD Joint Doctoral Program in Clinical Psychology, Department of Psychology, San Diego State University, 6363 Alvarado Court, San Diego, CA, 92120, USA. khorvath@sdsu.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lammert', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Thu', 'Initials': 'T', 'LastName': 'Danh', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Mitchell', 'Affiliation': ""Office of Public Health Studies, University of Hawai'i at Mānoa, Honolulu, HI, USA.""}]",AIDS and behavior,['10.1007/s10461-019-02755-7']
586,31802404,"A Phase I, Open-Label, Parallel-Group, Single-Dose Trial of the Pharmacokinetics, Safety, and Tolerability of Cannabidiol in Subjects with Mild to Severe Renal Impairment.","INTRODUCTION
As patients who receive cannabidiol (CBD) may have co-existing renal morbidities, it is important to understand whether dose adjustments are necessary to mitigate the risk of exposure-related toxicity. This study was conducted to evaluate the pharmacokinetics, safety, and tolerability of CBD in patients with renal impairment.
METHODS
The pharmacokinetics and safety of a single oral 200 mg dose of a plant-derived pharmaceutical formulation of highly purified CBD in oral solution (Epidiolex ® in the USA; 100 mg/mL) were assessed in subjects with mild, moderate, or severe renal impairment (n = 8/group) relative to matched subjects with normal renal function (n = 8). Blood samples were collected until 48 h post-dose and evaluated by liquid chromatography with tandem mass spectrometry. Analysis of variance was used to compare primary pharmacokinetic parameters (maximum measured plasma concentration [C max ], oral clearance of drug from plasma [CL/F], renal clearance [CL R ], area under the plasma concentration-time curve [AUC] from time zero to last measurable concentration [AUC t ], and AUC from time zero to infinity [AUC ∞ ]); descriptive analysis was used for secondary pharmacokinetic parameters (time to C max [t max ], terminal [elimination] half-life [t ½ ], cumulative amount excreted from time zero to the last quantifiable sample [Ae last ], and fraction of the systemically available drug excreted into the urine [f e ]).
RESULTS
No statistically significant differences were observed in C max , AUC t , AUC ∞ , or t max values between subjects with mild, moderate, or severe renal impairment and subjects with normal renal function for CBD or its major metabolites, 7-carboxy-CBD (7-COOH-CBD) and 7-hydroxy-CBD (7-OH-CBD), and minor metabolite, 6-hydroxy-CBD (6-OH-CBD); geometric mean ratio for C max values ranged from 0.68 to 1.35. No differences were observed for other secondary parameters (Ae last and f e ). CBD, 7-COOH-CBD, 7-OH-CBD, and 6-OH-CBD were highly protein bound (> 90%); binding was similar in all subject groups. Urine analysis for CBD recorded no appreciable amount, and thus no urinary pharmacokinetic parameters could be derived. Adverse events (AEs) affected two subjects; all five AEs were mild in severity and resolved during the trial. There were no serious AEs or discontinuations due to AEs. Laboratory, physical examination, vital sign, and 12-lead electrocardiogram findings were not clinically significant.
CONCLUSION
Renal impairment had no effect on the metabolism of CBD after a single oral 200 mg dose. CBD was generally well tolerated in subjects with varying degrees of renal function.
REGISTRATION
European Union Clinical Trials Register (EudraCT) no. 2015-002122-39.",2020,"No statistically significant differences were observed in C max , AUC t , AUC ∞ , or t max values between subjects with mild, moderate, or severe renal impairment and subjects with normal renal function for CBD or its major metabolites, 7-carboxy-CBD (7-COOH-CBD) and 7-hydroxy-CBD (7-OH-CBD), and minor metabolite, 6-hydroxy-CBD","['subjects with mild, moderate, or severe renal impairment (n\u2009=\u20098/group) relative to matched subjects with normal renal function (n\u2009=\u20098', 'subjects with varying degrees of renal function', 'patients with renal impairment', 'Subjects with Mild to Severe Renal Impairment']","['CBD', 'cannabidiol (CBD']","['plasma concentration [C max ], oral clearance of drug from plasma [CL/F], renal clearance [CL R ], area under the plasma concentration-time curve [AUC] from time zero to last measurable concentration [AUC t ], and AUC from time zero to infinity [AUC ∞ ]); descriptive analysis was used for secondary pharmacokinetic parameters (time to C max [t max ], terminal [elimination] half-life [t ½ ], cumulative amount excreted from time zero to the last quantifiable sample', 'CBD, 7-COOH-CBD, 7-OH-CBD, and 6-OH-CBD', 'normal renal function for CBD or its major metabolites, 7-carboxy-CBD (7-COOH-CBD) and 7-hydroxy-CBD (7-OH-CBD), and minor metabolite, 6-hydroxy-CBD', 'Blood samples', 'metabolism of CBD', 'pharmacokinetics, safety, and tolerability of CBD', 'Laboratory, physical examination, vital sign, and 12-lead electrocardiogram findings', 'C max , AUC t , AUC ∞ , or t max values']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance, function (observable entity)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0518766'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.055322,"No statistically significant differences were observed in C max , AUC t , AUC ∞ , or t max values between subjects with mild, moderate, or severe renal impairment and subjects with normal renal function for CBD or its major metabolites, 7-carboxy-CBD (7-COOH-CBD) and 7-hydroxy-CBD (7-OH-CBD), and minor metabolite, 6-hydroxy-CBD","[{'ForeName': 'Bola', 'Initials': 'B', 'LastName': 'Tayo', 'Affiliation': 'GW Research Ltd, Sovereign House, Vision Park, Histon, Cambridge, CB24 9BZ, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'GW Research Ltd, Sovereign House, Vision Park, Histon, Cambridge, CB24 9BZ, UK.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Sahebkar', 'Affiliation': 'Greenwich Biosciences, Inc., 5750 Fleet Street, Suite 200, Carlsbad, CA, 92008, USA.'}, {'ForeName': 'Gilmour', 'Initials': 'G', 'LastName': 'Morrison', 'Affiliation': 'GW Research Ltd, Sovereign House, Vision Park, Histon, Cambridge, CB24 9BZ, UK. GMorrison@gwpharm.com.'}]",Clinical pharmacokinetics,['10.1007/s40262-019-00841-6']
587,31804398,Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.,"OBJECTIVE
To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair.
SUMMARY OF BACKGROUND DATA
Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair.
METHODS
Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years.
RESULTS
126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh.
CONCLUSIONS
No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.",2019,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","['126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh']","['Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh', 'hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh', 'absorbable or nonabsorbable mesh repair']","['clinical symptom scores at 2, 3, and 5 years', 'recurrent hernia', 'chest pain, diarrhea, and bloat symptoms', 'hernia recurrence assessed by barium meal X-ray and endoscopy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0450093', 'cui_str': 'Very large (qualifier value)'}, {'cui': 'C3489393', 'cui_str': 'Hiatal Hernia'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}, {'cui': 'C0014857', 'cui_str': 'Repair of parahiatal diaphragmatic hernia (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0412103', 'cui_str': 'Barium meal (procedure)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",126.0,0.479725,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Watson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Thompson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Devitt', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Aly', 'Affiliation': 'University of Melbourne Department of Surgery, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Irvine', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Woods', 'Affiliation': 'Cabrini Hospital, Malvern, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gan', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Game', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Glyn G', 'Initials': 'GG', 'LastName': 'Jamieson', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}]",Annals of surgery,['10.1097/SLA.0000000000003734']
588,31804404,"A Prospective, Randomized Trial Comparing Respiratory Status During Anesthesia for Airway Stenting: Spontaneous Respiration Versus Controlled Ventilation With Muscle Relaxants.","BACKGROUND
Airway stenting is a procedure in which a stent is inserted into a stenotic site of the airway. The safest method of ventilation for airway stenting is controversial. A prospective randomized interventional study was conducted on airway stenting. We conducted this study to investigate whether controlled ventilation with muscle relaxants (MR) during airway stenting reduces the incidence of desaturation events (percutaneous oxygen saturation [SpO2] <95%) in comparison with spontaneous respiration (SP).
METHODS
Sixty-four patients were enrolled at our hospital between April 2016 and August 2018, and were randomly assigned to the controlled ventilation with MR group or SP group. For anesthesia, total intravenous anesthesia with propofol target-controlled infusion and remifentanil was performed. In the SP group, SP was maintained. In the MR group, a rigid bronchoscope was inserted after the administration of MR to perform controlled ventilation. The incidence of desaturation events was analyzed by logistic regression adjusted by the preoperative respiratory state and stenotic site of the airway.
RESULTS
The incidence of desaturation events in the SP and MR groups was 75.0% (24/32) and 9.7% (3/31), respectively, with an odds ratio of 0.04 (95% confidence interval, 0.01-0.16, reference = SP group; P < .001). In the SP group, the mean intraoperative pH was lower than that in the MR group (7.2 ± 0.1 vs 7.4 ± 0.1, respectively; P < .001). In this group, the mean partial pressure of arterial carbon dioxide (PaCO2) was higher (70.2 ± 17.0 mm Hg vs 40.5 ± 8.0 mm Hg, respectively; P < .001) and the mean partial pressure of oxygen in the arterial blood/fraction of the inspiratory oxygen ratio was lower (263.1 ± 64.2 mm Hg vs 396.4 ± 69.4 mm Hg, respectively; P < .001).
CONCLUSIONS
Controlled ventilation with MR during airway stenting reduced the incidence of desaturation events, maintaining a favorable respiratory status.",2020,"In this group, the mean partial pressure of arterial carbon dioxide (PaCO2) was higher (70.2 ± 17.0 mm Hg vs 40.5 ± 8.0 mm Hg, respectively; P < .001) and the mean partial pressure of oxygen in the arterial blood/fraction of the inspiratory oxygen ratio was lower (263.1 ± 64.2 mm Hg vs 396.4 ± 69.4 mm Hg, respectively; P < .001).
","['comparison with spontaneous respiration (SP', 'Sixty-four patients were enrolled at our hospital between April 2016 and August 2018']","['controlled ventilation with MR group or SP', 'propofol target-controlled infusion and remifentanil', 'rigid bronchoscope', 'controlled ventilation with muscle relaxants (MR']","['incidence of desaturation events', 'mean partial pressure of arterial carbon dioxide (PaCO2', 'mean partial pressure of oxygen in the arterial blood/fraction of the inspiratory oxygen ratio', 'mean intraoperative pH']","[{'cui': 'C0412771', 'cui_str': 'Spontaneous respiration (finding)'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0419011', 'cui_str': 'Controlled ventilation (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0179435', 'cui_str': 'Rigid bronchoscope (physical object)'}, {'cui': 'C0026827', 'cui_str': 'Hypomyotonia'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood (substance)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]",64.0,0.0447255,"In this group, the mean partial pressure of arterial carbon dioxide (PaCO2) was higher (70.2 ± 17.0 mm Hg vs 40.5 ± 8.0 mm Hg, respectively; P < .001) and the mean partial pressure of oxygen in the arterial blood/fraction of the inspiratory oxygen ratio was lower (263.1 ± 64.2 mm Hg vs 396.4 ± 69.4 mm Hg, respectively; P < .001).
","[{'ForeName': 'Sakura', 'Initials': 'S', 'LastName': 'Okamoto', 'Affiliation': 'From the *Department of Anesthesiology †Department of Clinical Research Planning and Management, Clinical Research Center ‡Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Namie', 'Initials': 'N', 'LastName': 'Somiya', 'Affiliation': ''}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'M Saito', 'Affiliation': ''}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Kada', 'Affiliation': ''}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Oki', 'Affiliation': ''}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': ''}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tomita', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004544']
589,31251892,Perceptually regulated training does not influence the differentiated RPE response following 16-weeks of aerobic exercise in adults with spinal cord injury.,"This study investigated the effect of prolonged familiarisation with ratings of perceived exertion (RPE) on the peripheral (RPE P ) and central (RPE C ) RPE responses to moderate-vigorous exercise in adults with spinal cord injury (SCI). RPE P and RPE C characterise the exertion of the working musculature and cardiorespiratory systems, respectively. Nineteen participants (age, 41.4 ± 11.4 years; peak oxygen uptake, 19.2 ± 7.2 mL·kg -1 ·min -1 ) with chronic SCI were randomly assigned to RPE-guided ( n = 11; EXP) or active control ( n = 8; CON) groups. EXP performed 16-weeks of RPE-guided, supervised aerobic training for 20 min, twice weekly, at RPE 3-6 (Category-Ratio 10 scale). CON had access to the same exercise equipment but received no specific advice on their exercise-training regime. Participants completed a graded exercise test, using an arm crank ergometer at pre- and post-training to determine peak oxygen uptake, with RPE P and RPE C recorded every minute throughout tests. Sixteen weeks training did not improve peak oxygen uptake. RPE decreased post-training at 50% ( p = 0.02) and 70% peak oxygen uptake ( p = 0.03), though there was no effect of group at either intensity ( p = 0.54, 0.42, respectively). At 70% peak oxygen uptake, RPE P was greater than RPE C (4.2 ± 1.7 vs 3.4 ± 1.8, p < 0.005). Training with RPE-guidance for 16 weeks had no additional effect on the differentiated RPE responses to moderate-vigorous exercise in adults with SCI. Novelty In adults with SCI, differentiated RPE responses were not different between those who did, and did not, perform 16 weeks of RPE-guided training. This challenges whether familiarisation with RPE is necessary to be an effective regulator of exercise intensity in this population.",2020,Training with RPE-guidance for 16-weeks had no additional effect on the differentiated RPE responses to moderate-vigorous exercise in adults with SCI. Novelty: •,"['adults with spinal cord injury', 'adults with spinal cord injury (SCI', 'Nineteen participants (41.4±11.4 years; 19.2±7.2 ml·kg-1·min-1) with chronic SCI']","['RPE-guided, supervised aerobic training', 'RPE2peak), with RPEP and RPEC recorded every minute throughout tests', 'Perceptually regulated training', 'aerobic exercise']","['RPE responses', 'V̇O2peak. RPE']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0558291', 'cui_str': 'Every minute (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0445208', 'cui_str': 'RPE'}]",,0.130176,Training with RPE-guidance for 16-weeks had no additional effect on the differentiated RPE responses to moderate-vigorous exercise in adults with SCI. Novelty: •,"[{'ForeName': 'Michael John', 'Initials': 'MJ', 'LastName': 'Hutchinson', 'Affiliation': 'Peter Harrison Centre for Disability Sport, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, LE11 3TU, UK.'}, {'ForeName': 'Sydney Ella', 'Initials': 'SE', 'LastName': 'Valentino', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, ON L8S 4L8, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Totosy de Zepetnek', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, ON L8S 4L8, Canada.'}, {'ForeName': 'Maureen Jane', 'Initials': 'MJ', 'LastName': 'MacDonald', 'Affiliation': 'Peter Harrison Centre for Disability Sport, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, LE11 3TU, UK.'}, {'ForeName': 'Victoria Louise', 'Initials': 'VL', 'LastName': 'Goosey-Tolfrey', 'Affiliation': 'Peter Harrison Centre for Disability Sport, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, LE11 3TU, UK.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0062']
590,31838596,Reduction of Streptococcus mutans by probiotic milk: a multicenter randomized controlled trial.,"OBJECTIVE
To investigate the effects of probiotics, Lactobacillus paracasei SD1, on the quantities of Streptococcus mutans in saliva and plaque samples of preschool children.
DESIGN
This randomized trial recruited 487 preschool children from eight childcare centers. Participants were assigned to receive a 6-month course of placebo milk daily (group I), probiotic milk either daily (group II) or three days a week (triweekly, group III). The absolute quantities of S. mutans and total lactobacilli in the saliva and plaque samples at baseline (T0), after intervention (T6), and 6 months after discontinuation (T12) were assessed by qPCR.
RESULTS
Of 487 children, 354 completed all follow-up periods. However, only 268 children (3.2 ± 0.8 years old; groups I = 86, II = 89, and III = 93) provided adequate saliva for qPCR. Whereas the quantities of S. mutans were significantly decreased in groups II and III compared to group I in the saliva and plaque samples at T6 and T12, those of total lactobacilli were significantly increased (p < 0.0167). There was no difference in the quantities of S. mutans or total lactobacilli between groups II and III at any period. Significant changes in the quantities of S. mutans and total lactobacilli lasted until T12 compared to T0 (p < 0.0167).
CONCLUSIONS
Probiotic administration daily or triweekly reduces S. mutans quantities, whereas it increases total lactobacilli quantities that persists at least 6 months after discontinuation in the saliva and plaque samples of preschool children.
CLINICAL RELEVANCE
Daily or triweekly consumption of L. paracasei SD1 supplemented in milk may help prevent dental caries in preschool children.",2020,There was no difference in the quantities of S. mutans or total lactobacilli between groups II and III at any period.,"['preschool children', 'Of 487 children, 354 completed all follow-up periods', '487 preschool children from eight childcare centers', '268 children (3.2 ± 0.8 years old; groups I = 86, II = 89, and III = 93) provided']","['probiotic milk', 'SD1', 'placebo milk daily (group I), probiotic milk either daily', 'probiotics, Lactobacillus paracasei SD1', 'L. paracasei']","['quantities of S. mutans and total lactobacilli', 'total lactobacilli quantities', 'absolute quantities of S. mutans and total lactobacilli', 'quantities of S. mutans or total lactobacilli', 'total lactobacilli', 'adequate saliva for qPCR', 'dental caries', 'quantities of S. mutans']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1861380', 'cui_str': 'Syndactyly, Type I'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}]",487.0,0.0303064,There was no difference in the quantities of S. mutans or total lactobacilli between groups II and III at any period.,"[{'ForeName': 'Chanika', 'Initials': 'C', 'LastName': 'Manmontri', 'Affiliation': 'Division of Pediatric Dentistry, Department of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Areerat', 'Initials': 'A', 'LastName': 'Nirunsittirat', 'Affiliation': 'Center of Excellence in Oral and Maxillofacial Biology, Faculty of Dentistry, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Supatcharin', 'Initials': 'S', 'LastName': 'Piwat', 'Affiliation': 'Common Oral Diseases and Epidemiology Research Center, Faculty of Dentistry, Prince of Songkla University, Hat Yai, Songkhla, 90112, Thailand.'}, {'ForeName': 'Onnida', 'Initials': 'O', 'LastName': 'Wattanarat', 'Affiliation': 'Division of Pediatric Dentistry, Department of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Nuntiya', 'Initials': 'N', 'LastName': 'Pahumunto', 'Affiliation': 'Common Oral Diseases and Epidemiology Research Center, Faculty of Dentistry, Prince of Songkla University, Hat Yai, Songkhla, 90112, Thailand.'}, {'ForeName': 'Anupong', 'Initials': 'A', 'LastName': 'Makeudom', 'Affiliation': 'Center of Excellence in Oral and Maxillofacial Biology, Faculty of Dentistry, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Thanapat', 'Initials': 'T', 'LastName': 'Sastraruji', 'Affiliation': 'Center of Excellence in Oral and Maxillofacial Biology, Faculty of Dentistry, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Suttichai', 'Initials': 'S', 'LastName': 'Krisanaprakornkit', 'Affiliation': 'Center of Excellence in Oral and Maxillofacial Biology, Faculty of Dentistry, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Rawee', 'Initials': 'R', 'LastName': 'Teanpaisan', 'Affiliation': 'Common Oral Diseases and Epidemiology Research Center, Faculty of Dentistry, Prince of Songkla University, Hat Yai, Songkhla, 90112, Thailand. rawee.t@psu.ac.th.'}]",Clinical oral investigations,['10.1007/s00784-019-03095-5']
591,31270591,Comparable clinical outcome and implant longevity after CT- or MRI-based patient-specific instruments for total knee arthroplasty: a 2-year follow-up of a RCT.,"PURPOSE
Patient-specific instruments (PSI) are already widespread used in total knee arthroplasty (TKA). Either computed tomography (CT) scans or magnetic resonance imaging (MRI) scans are used pre-operatively to create jigs to guide resection during surgery. This study is a sequel of previous work that showed significantly more radiological outliers for posterior slope when CT-based guides were used. The aim of this study was to assess differences in revision rate and clinical outcome between the two groups at 2-year follow-up.
METHODS
At the 2-year follow-up, 124 patients were analysed in this prospective, randomised single-blind study. A survival analysis with revision of the TKA as endpoint was performed. Patients fulfilled four patient-reported outcome measurements (PROMs). Scores on the questionnaires were compared between both groups at the different follow-up visits.
RESULTS
At final follow-up, there was no significant difference in the survival rates of the CT- and MRI-based PSI surgery. Postoperatively, the PROMs significantly improved within each group compared with the pre-operative values. There were no significant differences for the PROMs between both groups at the 2-years follow-up.
CONCLUSIONS
Although previous results showed more outliers regarding posterior slope for CT-based PSIs, no difference in revision rate or the outcome of PROMs was found at 2-year follow-up. Further research to determine what the influence is of radiological outliers on implant survival and clinical outcomes is necessary.
LEVEL OF EVIDENCE
I.",2020,"At final follow-up, there was no significant difference in the survival rates of the CT- and MRI-based PSI surgery.","['124 patients', 'total knee arthroplasty']","['computed tomography (CT) scans or magnetic resonance imaging (MRI) scans', 'CT- or MRI-based patient-specific instruments']","['survival rates', 'revision rate', 'revision rate and clinical outcome', 'PROMs']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}]",124.0,0.0473502,"At final follow-up, there was no significant difference in the survival rates of the CT- and MRI-based PSI surgery.","[{'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Thijs', 'Affiliation': 'Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Dieuwertje', 'Initials': 'D', 'LastName': 'Theeuwen', 'Affiliation': 'Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Boonen', 'Affiliation': 'Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'van Haaren', 'Affiliation': 'Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Hendrickx', 'Affiliation': 'Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Rein', 'Initials': 'R', 'LastName': 'Vos', 'Affiliation': 'Department of Methodology and Statistics, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Borghans', 'Affiliation': 'Department of Radiology, Zuyderland Medical Center, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Nanne', 'Initials': 'N', 'LastName': 'Kort', 'Affiliation': ', Roosteren, The Netherlands.'}, {'ForeName': 'Martijn G M', 'Initials': 'MGM', 'LastName': 'Schotanus', 'Affiliation': 'Department of Orthopaedic Surgery, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands. martijnschotanus@hotmail.com.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05616-x']
592,31251889,Evidence of a limb- and shear stress stimulus profile-dependent impact of high-intensity cycling training on flow-mediated dilation.,"Lower limb endurance training can improve conduit artery flow-mediated dilation (FMD) in response to transient increases in shear stress (reactive hyperemia; RH-FMD) in both the upper and lower limbs. Sustained increases in shear stress recruit a partially distinct transduction pathway and elicit a physiologically relevant FMD response (SS-FMD) that provides distinct information regarding endothelial function. However, the impact of training on SS-FMD is not well understood. The purpose of this study was to determine the impact of cycling training on handgrip exercise-induced brachial artery (BA) FMD (BA SS-FMD) and calf plantar-flexion-induced superficial femoral artery (SFA) FMD (SFA SS-FMD). RH-FMD was also assessed in both arteries. Twenty-eight young males were randomized to control ( n = 12) or training ( n = 16) groups. The training group cycled 30 min/day, 3 days/week for 4 weeks at 80% heart rate reserve. FMD was assessed in the BA and SFA before and after the intervention via Duplex ultrasound. Results are means ± SD. Training did not impact SS-FMD in either artery, and SFA RH-FMD was also unchanged ( p > 0.05). When controlling for the shear rate stimulus via covariate analysis, BA RH-FMD improved in the training group ( p = 0.05) (control - pre-intervention: 5.7% ± 2.4%, post-intervention: 5.3% ± 2.4%; training - pre-intervention: 5.4% ± 2.5%, post-intervention: 7.2% ± 2.4%). Thus, endurance training resulted in nonuniform adaptations to endothelial function, with an isolated impact on the BA's ability to transduce a transient increase in shear stress. Novelty Training did not alter SS-FMD in the arm or leg. RH-FMD was augmented in the arm only. Thus training adaptations were limb- and shear stress profile-specific.",2020,Lower limb endurance training can improve conduit artery flow-mediated dilation (FMD) in response to transient increases in shear stress (reactive hyperemia; RH-FMD) in both the upper and lower limbs.,['28 young males'],"['endurance training', 'limb endurance training', 'high intensity cycling training', 'cycling training']","['FMD', 'conduit artery flow-mediated dilation (FMD', 'SFA RH-FMD', 'shear stress', 'BA RH-FMD', 'FMD (BA SS-FMD) and calf plantar-flexion induced superficial femoral artery (SFA) FMD (SFA SS-FMD', 'RH-FMD', 'SS-FMD', 'flow-mediated dilation', 'shear stress (reactive hyperemia; RH-FMD', '• RH-FMD', 'brachial artery(BA']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0441247', 'cui_str': 'Conduit (physical object)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion, function (observable entity)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0447106', 'cui_str': 'Superficial femoral artery (body structure)'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}]",28.0,0.0241255,Lower limb endurance training can improve conduit artery flow-mediated dilation (FMD) in response to transient increases in shear stress (reactive hyperemia; RH-FMD) in both the upper and lower limbs.,"[{'ForeName': 'Trevor J', 'Initials': 'TJ', 'LastName': 'King', 'Affiliation': ""Cardiovascular Stress Response Lab, School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Kyra E', 'Initials': 'KE', 'LastName': 'Pyke', 'Affiliation': ""Cardiovascular Stress Response Lab, School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, Canada.""}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0151']
593,31253489,An on-line support tool to reduce exercise-related hypoglycaemia and improve confidence to exercise in type 1 diabetes.,"OBJECTIVE
Hypoglycaemia related to exercise and lack of confidence to exercise, are common in T1DM. An online educational exercise tool (ExT1D) was tested to determine whether these parameters can be improved.
RESEARCH DESIGN AND METHODS
Thirty two adults with T1DM (50%M, age 35.8 ± 9.5 yr diabetes duration 12.3 ± 9.9 yr, median HbA1c 7.1%[ICR 6.4-7.7] NGSPU) exercising ≥ 60 min/week enrolled in a RCT utilising ExT1D, with partial cross-over design. The primary end-point was Exercise-related hypoglycaemia (ErH) number corrected for exercise session number, with ErH defined as CGM episodes < 4.0 mM occurring within 24 h of exercise. Secondary RCT endpoints were total ErH duration, and ErH duration/episode. A pre-defined longitudinal analysis with each subject compared with their baseline was also undertaken, for the three ErH parameters, and using fear of hypoglycaemia questionnaires.
RESEARCH
In the RCT a 50% lower median ErH number (P = 0.6) (37% lower ErH number per exercise session (P = 0.06, NS primary endpoint) occurred in the Intervention vs Control group. A 49% lower ErH duration per episode (P = 0.2), and 80% less ErH duration (P = 0.3), were also observed in the Intervention vs Control group. In the longitudinal study, ErH number reduced by 43% (P = 0.088), ErH duration per episode by 52% (P = 0.157) and total duration of ErH fell by 71% (P = 0.015). Confidence to prevent glucose lowering by exercise also improved (P = 0.039). Post-hoc analysis showed those with the greatest ErH events at baseline benefited most. Fructosamine and HbA1c levels were unchanged from baseline.
CONCLUSIONS
ExT1D can reduce exercise-related hypoglycaemia and provide greater confidence to exercise.",2019,"In the RCT a 50% lower median ErH number (P = 0.6) (37% lower ErH number per exercise session (P = 0.06, NS primary endpoint) occurred in the Intervention vs Control group.","['Thirty two adults with T1DM (50%M, age 35.8\u202f±\u202f9.5\u202fyr diabetes duration 12.3\u202f±\u202f9.9\u202fyr']",['online educational exercise tool (ExT1D'],"['Exercise-related hypoglycaemia (ErH) number corrected for exercise session number, with ErH defined as CGM episodes', 'median ErH number', 'total duration of ErH fell', 'ErH duration per episode', 'ErH duration', 'Fructosamine and HbA1c levels', 'median HbA1c', 'total ErH duration, and ErH duration/episode']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0060765', 'cui_str': 'D-Isoglucosamine'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",32.0,0.0995456,"In the RCT a 50% lower median ErH number (P = 0.6) (37% lower ErH number per exercise session (P = 0.06, NS primary endpoint) occurred in the Intervention vs Control group.","[{'ForeName': 'Agata K', 'Initials': 'AK', 'LastName': 'Piotrowicz', 'Affiliation': 'Diabetes Centre, Department of Endocrinology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'McGill', 'Affiliation': 'Diabetes Centre, Department of Endocrinology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Overland', 'Affiliation': 'Diabetes Centre, Department of Endocrinology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Molyneaux', 'Affiliation': 'Diabetes Centre, Department of Endocrinology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia; Faculty of Health Sciences, The University of Sydney, Sydney, NSW 2006, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Twigg', 'Affiliation': 'Diabetes Centre, Department of Endocrinology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia. Electronic address: Stephen.twigg@sydney.edu.au.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.05.011']
594,32410362,Combination of oral methotrexate and oral mini-pulse dexamethasone vs either agent alone in vitiligo treatment with follow up by dermoscope.,"This study aimed to compare the efficacy and safety of oral methotrexate (MTX) and oral mini-pulse (OMP) dexamethasone alone and in combination in the treatment of vitiligo. A total of 42 patients with vitiligo were included in the study. The patients were treated for three months and randomly assigned into three groups including 14 patients each: group A received oral MTX, group B received OMP dexamethasone, and group C received a combination of both. Follow-up was performed using digital photographs, Vitiligo European Task Force score, and dermoscopy. Disease extension significantly decreased in group C compared with that in groups A (P < .001) and B (P < .05). The frequency of intralesional pigmentation significantly increased (P < .05) in groups A and C and decreased (P < .05) in group B posttreatment noted using a dermoscope. Moreover, the frequency of micro-Koebner's phenomenon and starburst pattern significantly decreased (P < .05) in groups B and C and that of tapioca sago in group C only posttreatment.",2020,Disease extension significantly decreased in group C compared with that in groups A (p < 0.001) and B (p < 0.05).,"['42 patients with vitiligo were included in the study', 'vitiligo']","['oral methotrexate (MTX) and oral mini-pulse (OMP) dexamethasone', 'oral methotrexate and oral mini-pulse dexamethasone', 'oral MTX', 'OMP dexamethasone']","[""frequency of micro-Koebner's phenomenon and starburst pattern"", 'efficacy and safety', 'Disease extension', 'frequency of intralesional pigmentation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0263367', 'cui_str': 'Köbner phenomenon'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}]",42.0,0.0246827,Disease extension significantly decreased in group C compared with that in groups A (p < 0.001) and B (p < 0.05).,"[{'ForeName': 'Mohamed Ibrahim', 'Initials': 'MI', 'LastName': 'ElGhareeb', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Metwalli', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Nehal', 'Initials': 'N', 'LastName': 'AbdelMoneim', 'Affiliation': 'Resident Dermatologist, Alhaud Almarsoud hospital, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13586']
595,31799996,Effect of Topical Brimonidine on Alcohol-Induced Flushing in Asian Individuals: A Randomized Clinical Trial.,"Importance
Alcohol flushing syndrome (AFS, also known as Asian glow and Asian flush) affects 20% to 47% of East Asians and causes significant psychosocial distress. There are no approved treatments for this condition.
Objective
To determine whether brimonidine gel, 0.33%, decreases facial erythema in patients with AFS after consumption of alcohol.
Design, Setting, and Participants
In this randomized clinical trial, 20 healthy volunteers of East Asian descent with a self-reported history of AFS were recruited between April 2018 and March 2019.
Interventions
Participants were randomized to application of brimonidine gel to either the left or right half of their face. Placebo control was applied to the opposite side. After 30 minutes, participants ingested alcohol.
Main Outcomes and Measures
Outcomes were specified before data collection. The difference in erythema between the treated and placebo side of each participant's face was measured 60 minutes after drug application (primary outcome) and at 90 and 120 minutes after drug application (secondary outcomes). Participants were asked to rate their likelihood of using the medication again and their likelihood of recommending the medication to a friend on a scale of 0 to 10.
Results
The mean (SD) age of the 20 individuals enrolled in the study was 30.5 (8.4) years, and there were 10 women (50%). There was a significant difference in erythema at 60 minutes after drug application as measured by the difference in Clinician Erythema Assessment score (2.1; 95% CI, 1.5-2.71; P < .001) and by the difference in Subject Self-Assessment score (1.7; 95% CI, 1.1- 2.3; P < .001). This effect persisted at 90 and 120 minutes. Individuals were likely to use the medication again (7.2; 95% CI, 6.0-8.3) and would also recommend it to a friend (7.6; 95% CI, 6.5-8.6).
Conclusions and Relevance
This study demonstrates that brimonidine gel is effective in reducing the facial erythema of AFS. Patients with psychosocial distress due to AFS may benefit from treatment with brimonidine.
Trial Registration
ClinicalTrials.gov identifier: NCT03497442.",2020,"There was a significant difference in erythema at 60 minutes after drug application as measured by the difference in Clinician Erythema Assessment score (2.1; 95% CI, 1.5-2.71; P < .001) and by the difference in Subject Self-Assessment score (1.7; 95% CI, 1.1- 2.3; P < .001).","['patients with AFS after consumption of alcohol', '20 healthy volunteers of East Asian descent with a self-reported history of AFS were recruited between April 2018 and March 2019', 'Asian Individuals', 'Patients with psychosocial distress', 'The mean (SD) age of the 20 individuals enrolled in the study was 30.5 (8.4) years, and there were 10 women (50']","['Topical Brimonidine', 'brimonidine gel', 'brimonidine', 'Placebo']","['Clinician Erythema Assessment score', 'facial erythema of AFS', 'erythema', 'Subject Self-Assessment score', 'facial erythema']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0525227', 'cui_str': 'brimonidine'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}]",20.0,0.0595844,"There was a significant difference in erythema at 60 minutes after drug application as measured by the difference in Clinician Erythema Assessment score (2.1; 95% CI, 1.5-2.71; P < .001) and by the difference in Subject Self-Assessment score (1.7; 95% CI, 1.1- 2.3; P < .001).","[{'ForeName': 'Wesley Y', 'Initials': 'WY', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tan', 'Affiliation': 'University of California School of Medicine, San Francisco.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Aroyan', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Kanade', 'Initials': 'K', 'LastName': 'Shinkai', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Kieron S', 'Initials': 'KS', 'LastName': 'Leslie', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Lindy P', 'Initials': 'LP', 'LastName': 'Fox', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Siegrid', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Isaac M', 'Initials': 'IM', 'LastName': 'Neuhaus', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Roy C', 'Initials': 'RC', 'LastName': 'Grekin', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Arron', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}]",JAMA dermatology,['10.1001/jamadermatol.2019.3508']
596,31699735,"CRISTAL: protocol for a cluster randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study.","INTRODUCTION
Venous thromboembolism (VTE) is a serious complication following hip arthroplasty (HA) and knee arthroplasty (KA). This study aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic VTE following HA and KA.
METHODS AND ANALYSIS
This is a cluster randomised, crossover, non-inferiority, trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will consist of Australian hospitals performing at least 250 HA and/or KA procedures per annum. All adult patients undergoing HA or KA will be included. The intervention will be aspirin, orally, 85-150 mg daily. The comparator will be LMWH (enoxaparin) 40 mg, subcutaneously, daily. Both drugs will commence within 24 hours postoperatively and continue for 35 days after HA and 14 days after KA. Each hospital will be randomised to commence with aspirin or LMWH and then crossover to the alternative treatment after meeting the recruitment target. Data will be collected through the AOANJRR via patient-reported surveys. The primary outcome is symptomatic VTE within 90 days post surgery, verified by AOANJRR staff. The primary analysis will include only patients undergoing elective primary total hip arthroplasty and total knee arthroplasty for osteoarthritis. Secondary outcomes will include symptomatic VTE for all HA and KA (including partial and revision) within 90 days, readmission, reoperation, major bleeding and death within 90 days and reoperation, death and patient-reported pain, function and health status at 6 months. If aspirin is found to be inferior, a cost-effectiveness analysis will be conducted. The study will aim to recruit 15 562 patients from 31 hospitals.
ETHICS AND DISSEMINATION
Ethics approval has been granted. Trial results will be submitted for publication. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618001879257, pre-results) and is endorsed by the Australia and New Zealand Musculoskeletal Clinical Trials Network.",2019,"This study aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic VTE following HA and KA.
","['patients undergoing elective primary total hip arthroplasty and total knee arthroplasty for osteoarthritis', 'hip or knee arthroplasty, a registry nested study', 'recruit 15\u2009562 patients from 31 hospitals', 'All adult patients undergoing HA or KA', 'hip arthroplasty (HA) and knee arthroplasty (KA']","['LMWH (enoxaparin', 'aspirin or LMWH', 'aspirin']","['symptomatic VTE within 90 days post surgery, verified by AOANJRR staff', 'symptomatic VTE for all HA and KA (including partial and revision) within 90 days, readmission, reoperation, major bleeding and death within 90 days and reoperation, death and patient-reported pain, function and health status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",250.0,0.254228,"This study aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic VTE following HA and KA.
","[{'ForeName': 'Verinder Singh', 'Initials': 'VS', 'LastName': 'Sidhu', 'Affiliation': 'CRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia verinder.s.sidhu@gmail.com.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Graves', 'Affiliation': 'Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Buchbinder', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Justine Maree', 'Initials': 'JM', 'LastName': 'Naylor', 'Affiliation': 'CRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Pratt', 'Affiliation': 'School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'de Steiger', 'Affiliation': 'Department of Surgery, Epworth Healthcare, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Beng H', 'Initials': 'BH', 'LastName': 'Chong', 'Affiliation': 'Department of Haematology, Saint George and Sutherland Clinical School, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ilana N', 'Initials': 'IN', 'LastName': 'Ackerman', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Adie', 'Affiliation': 'Faculty of Medicine, Saint George and Sutherland Clinical School, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Harris', 'Affiliation': 'Monash University Centre for Health Economics, Caufield, Victoria, Australia.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Hansen', 'Affiliation': 'CRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Cripps', 'Affiliation': 'CRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Lorimer', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Webb', 'Affiliation': 'Department of Intensive Care, St John of God Hospital, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Clavisi', 'Affiliation': 'Musculoskeletal Australia, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Griffith', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Durga', 'Initials': 'D', 'LastName': 'Anandan', 'Affiliation': 'Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': ""O'Donohue"", 'Affiliation': 'Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia.'}, {'ForeName': 'Thu-Lan', 'Initials': 'TL', 'LastName': 'Kelly', 'Affiliation': 'School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Harris', 'Affiliation': 'CRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-031657']
597,31796571,Glucose and Counterregulatory Responses to Exercise in Adults With Type 1 Diabetes and Impaired Awareness of Hypoglycemia Using Closed-Loop Insulin Delivery: A Randomized Crossover Study.,"OBJECTIVE
To evaluate exercise-related glucose and counterregulatory responses (CRR) in adults with type 1 diabetes with impaired awareness of hypoglycemia (IAH) using hybrid closed-loop (HCL) insulin delivery to maintain glucose homeostasis.
RESEARCH DESIGN AND METHODS
Twelve participants undertook 45-min high-intensity intermittent exercise (HIIE) and moderate-intensity exercise (MIE) in random order. The primary outcome was continuous glucose monitoring (CGM) time in range (70-180 mg/dL) for 24-h post-exercise commencement.
RESULTS
CGM time in range was similar for HIIE and MIE (median 79.5% [interquartile range 73.2, 87.6] vs. 76.1% [70.3, 83.9], P = 0.37), and time with levels <54mg/dL post-exercise commencement was 0%. HIIE induced greater increases in cortisol ( P = 0.002), noradrenaline ( P = 0.005), and lactate ( P = 0.002), with no differences in adrenaline, dopamine, growth hormone, or glucagon responses.
CONCLUSIONS
IAH adults using HCL undertaking HIIE and MIE exhibit heterogeneity in CRR. Novel findings were a preserved cortisol response and variable catecholamine responses to HIIE.",2020,"HIIE induced greater increases in cortisol ( P = 0.002), noradrenaline ( P = 0.005), and lactate ( P = 0.002), with no differences in adrenaline, dopamine, growth hormone, or glucagon responses.
","['Twelve participants undertook 45-min high', 'Adults With Type 1 Diabetes and Impaired Awareness of Hypoglycemia', 'adults with type 1 diabetes with impaired awareness of hypoglycemia (IAH']","['hybrid closed-loop (HCL) insulin delivery', 'intensity intermittent exercise (HIIE) and moderate-intensity exercise (MIE', 'exercise-related glucose and counterregulatory responses (CRR', 'Closed-Loop Insulin Delivery']","['Glucose and Counterregulatory Responses', 'adrenaline, dopamine, growth hormone, or glucagon responses', 'cortisol', 'continuous glucose monitoring (CGM) time', 'noradrenaline']","[{'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]",12.0,0.0828513,"HIIE induced greater increases in cortisol ( P = 0.002), noradrenaline ( P = 0.005), and lactate ( P = 0.002), with no differences in adrenaline, dopamine, growth hormone, or glucagon responses.
","[{'ForeName': 'Melissa H', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vogrin', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Paldus', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Dilshani', 'Initials': 'D', 'LastName': 'Jayawardene', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Jones', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Sybil A', 'Initials': 'SA', 'LastName': 'McAuley', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Varuni', 'Initials': 'V', 'LastName': 'Obeyesekere', 'Affiliation': ""Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Melbourne, Australia.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gooley', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'La Gerche', 'Affiliation': ""Department of Cardiology, St Vincent's Hospital Melbourne, Melbourne, Australia.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'MacIsaac', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Vijaya', 'Initials': 'V', 'LastName': 'Sundararajan', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Alicia J', 'Initials': 'AJ', 'LastName': 'Jenkins', 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Ward', 'Affiliation': ""Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Melbourne, Australia.""}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': ""O'Neal"", 'Affiliation': 'University of Melbourne, Department of Medicine, Melbourne, Australia dno@unimelb.edu.au.'}]",Diabetes care,['10.2337/dc19-1433']
598,31244367,Determination of glycemic index of enteral formulas used in clinical practice.,"Glycemic Index (GI) is a measure of carbohydrate quality and is recognised as a valid and reproducible method of classifying carbohydrate foods according to its effects on postprandial glycaemia. In this randomised crossover trial (RBR-7rjx3k) we determined the GI of nine enteral formulas, following the Food and Agriculture Organisation/World Health Organisation method. Forty healthy participants were included in the study (85% female mean age 27.1 ± 6.7 years). GI of the enteral formulas ranged from 40.5 to 85.2; four formulas had high GI (Nutrienteral 1.5 ® , Novasource GI Control ® , Diamax ® , Isosource Soya ® ), two intermediate GI (Fresubin 1.2 HP Fibre ® , Nutrison Energy Multifiber 1.5 ® ) and three low GI (Trophic 1.5 ® , Glucerna ® , Novasource GC HP ® ). The GI coefficient of variation ranged from 22.9% to 83.6%. The effect of the enteral formulas with low GI in glycemic control of patients with enteral nutrition prescription needs to be test in future studies.",2020,"GI of the enteral formulas ranged from 40.5 to 85.2; four formulas had high GI (Nutrienteral 1.5 ® , Novasource GI Control ® , Diamax ® , Isosource Soya ® ), two intermediate GI (Fresubin 1.2 HP Fibre ® , Nutrison Energy Multifiber 1.5 ® ) and three low GI (Trophic 1.5 ® , Glucerna ® , Novasource GC HP ® ).","['patients with enteral nutrition prescription', 'Forty healthy participants were included in the study (85% female mean age 27.1\u2009±\u20096.7\u2009years']",['enteral formulas with low GI'],['Glycemic Index (GI'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0311187', 'cui_str': 'Enteral formula'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}]",40.0,0.0404251,"GI of the enteral formulas ranged from 40.5 to 85.2; four formulas had high GI (Nutrienteral 1.5 ® , Novasource GI Control ® , Diamax ® , Isosource Soya ® ), two intermediate GI (Fresubin 1.2 HP Fibre ® , Nutrison Energy Multifiber 1.5 ® ) and three low GI (Trophic 1.5 ® , Glucerna ® , Novasource GC HP ® ).","[{'ForeName': 'Jéssica Abdo Gonçalves', 'Initials': 'JAG', 'LastName': 'Tosatti', 'Affiliation': 'Nutrition Department, Federal University of Minas Gerais - UFMG, Belo Horizonte, Brazil.'}, {'ForeName': 'Victória Bortolosso', 'Initials': 'VB', 'LastName': 'Bocardi', 'Affiliation': 'Nutrition Department, Federal University of Minas Gerais - UFMG, Belo Horizonte, Brazil.'}, {'ForeName': 'Ann Kristine', 'Initials': 'AK', 'LastName': 'Jansen', 'Affiliation': 'Nutrition Department, Federal University of Minas Gerais - UFMG, Belo Horizonte, Brazil.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Bernandes', 'Affiliation': 'Risoleta Tolentino Neves Hospital, Belo Horizonte, Brazil.'}, {'ForeName': 'Flávia Moraes', 'Initials': 'FM', 'LastName': 'Silva', 'Affiliation': 'Nutrition Department and Postgraduation Program of Nutrition Science of Federal University of Healthy Science of Porto Alegre - UFCSPA, Porto Alegre, Brazil.'}]",International journal of food sciences and nutrition,['10.1080/09637486.2019.1634011']
599,31162529,Association of Quetiapine Overuse Letters With Prescribing by Physician Peers of Targeted Recipients: A Secondary Analysis of a Randomized Clinical Trial.,,2019,,['Overuse Letters With Prescribing by Physician Peers of Targeted Recipients'],['Quetiapine'],[],"[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}]",[],,0.0526203,,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sacarny', 'Affiliation': 'Department of Health Policy and Management, Mailman School of Public Health, Columbia University, New York, New York.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Olenski', 'Affiliation': 'Department of Economics, Columbia University, New York, New York.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Barnett', 'Affiliation': 'Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.1418']
600,31166571,Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial.,"Importance
Controlled studies have shown short-term efficacy of esketamine for treatment-resistant depression (TRD), but long-term effects remain to be established.
Objective
To assess the efficacy of esketamine nasal spray plus an oral antidepressant compared with an oral antidepressant plus placebo nasal spray in delaying relapse of depressive symptoms in patients with TRD in stable remission after an induction and optimization course of esketamine nasal spray plus an oral antidepressant.
Design, Setting, and Participants
In this phase 3, multicenter, double-blind, randomized withdrawal study conducted from October 6, 2015, to February 15, 2018, at outpatient referral centers, 705 adults with prospectively confirmed TRD were enrolled; 455 entered the optimization phase and were treated with esketamine nasal spray (56 or 84 mg) plus an oral antidepressant. After 16 weeks of esketamine treatment, 297 who achieved stable remission or stable response entered the randomized withdrawal phase.
Interventions
Patients who achieved stable remission and those who achieved stable response (without remission) were randomized 1:1 to continue esketamine nasal spray or discontinue esketamine treatment and switch to placebo nasal spray, with oral antidepressant treatment continued in each group.
Main Outcomes and Measures
Time to relapse was examined in patients who achieved stable remission, as assessed using a weighted combination log-rank test.
Results
Among the 297 adults (mean age [SD], 46.3 [11.13] years; 197 [66.3%] female) who entered the randomized maintenance phase, 176 achieved stable remission; 24 (26.7%) in the esketamine and antidepressant group and 39 (45.3%) in the antidepressant and placebo group experienced relapse (log-rank P = .003, number needed to treat [NNT], 6). Among the 121 who achieved stable response, 16 (25.8%) in the esketamine and antidepressant group and 34 (57.6%) in the antidepressant and placebo group experienced relapse (log-rank P < .001, NNT, 4). Esketamine and antidepressant treatment decreased the risk of relapse by 51% (hazard ratio [HR], 0.49; 95% CI, 0.29-0.84) among patients who achieved stable remission and 70% (HR, 0.30; 95% CI, 0.16-0.55) among those who achieved stable response compared with antidepressant and placebo treatment. The most common adverse events reported for esketamine-treated patients after randomization were transient dysgeusia, vertigo, dissociation, somnolence, and dizziness (incidence, 20.4%-27.0%), each reported in fewer patients (<7%) treated with an antidepressant and placebo.
Conclusions and Relevance
For patients with TRD who experienced remission or response after esketamine treatment, continuation of esketamine nasal spray in addition to oral antidepressant treatment resulted in clinically meaningful superiority in delaying relapse compared with antidepressant plus placebo.
Trial Registration
ClinicalTrials.gov identifier: NCT02493868.",2019,"Among the 121 who achieved stable response, 16 (25.8%) in the esketamine and antidepressant group and 34 (57.6%) in the antidepressant and placebo group experienced relapse (log-rank P < .001, NNT, 4).","['patients with TRD', '297 adults (mean age [SD], 46.3 [11.13] years; 197 [66.3%] female) who entered the randomized maintenance phase, 176 achieved stable remission; 24 (26.7%) in the esketamine and antidepressant group and 39 (45.3%) in the', '297 who achieved stable remission or stable response entered the randomized withdrawal phase', 'Patients With Treatment-Resistant Depression', 'Interventions\n\n\nPatients who achieved stable remission and those who achieved stable response (without remission', 'patients with TRD in stable remission after an induction and optimization course of esketamine nasal spray plus an oral antidepressant', 'from October 6, 2015, to February 15, 2018, at outpatient referral centers, 705 adults with prospectively confirmed TRD were enrolled; 455 entered the optimization phase and were treated with']","['Esketamine Nasal Spray Plus Oral Antidepressant Treatment', 'placebo', 'antidepressant and placebo', 'esketamine nasal spray (56 or 84 mg) plus an oral antidepressant', 'esketamine nasal spray', 'esketamine', 'oral antidepressant plus placebo nasal spray', 'esketamine nasal spray or discontinue esketamine treatment and switch to placebo nasal spray, with oral antidepressant treatment continued in each group']","['risk of relapse', 'relapse', 'relapse of depressive symptoms', 'Measures\n\n\nTime to relapse', 'transient dysgeusia, vertigo, dissociation, somnolence, and dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2825616'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C2825616'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0013378', 'cui_str': 'Taste, Distorted'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0086168', 'cui_str': 'Dissociation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",705.0,0.192917,"Among the 121 who achieved stable response, 16 (25.8%) in the esketamine and antidepressant group and 34 (57.6%) in the antidepressant and placebo group experienced relapse (log-rank P < .001, NNT, 4).","[{'ForeName': 'Ella J', 'Initials': 'EJ', 'LastName': 'Daly', 'Affiliation': 'Department of Neuroscience, Janssen Research and Development LLC, Titusville, New Jersey.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Janik', 'Affiliation': 'Department of Neuroscience, Janssen Research and Development LLC, San Diego, California.'}, {'ForeName': 'Honglan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Neuroscience, Janssen Research and Development LLC, Titusville, New Jersey.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Biostatistics, Janssen Research and Development LLC, Fremont, California.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Biostatistics, Janssen Research and Development LLC, Raritan, New Jersey.'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Lane', 'Affiliation': 'Department of Clinical Biostatistics, Janssen Research and Development LLC, Titusville, New Jersey.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Lim', 'Affiliation': 'Department of Clinical Biostatistics, Janssen Research and Development LLC, Titusville, New Jersey.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Duca', 'Affiliation': 'Department of Neuroscience, Janssen Research and Development LLC, Titusville, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hough', 'Affiliation': 'Department of Neuroscience, Janssen Research and Development LLC, Titusville, New Jersey.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zajecka', 'Affiliation': 'Department of Psychiatry, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Winokur', 'Affiliation': 'Department of Psychiatry, University of Connecticut Health, Farmington.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Divacka', 'Affiliation': 'Private practice, Prague, Czech Republic.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fagiolini', 'Affiliation': 'Department of Molecular Medicine, Division of Psychiatry, University of Siena, Siena, Italy.'}, {'ForeName': 'Wieslaw J', 'Initials': 'WJ', 'LastName': 'Cubala', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Bitter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blier', 'Affiliation': 'Departments of Psychiatry and Cellular/Molecular Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry, University of Alabama School of Medicine, Birmingham.'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Molero', 'Affiliation': 'Department of Psychiatry, Clinica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Husseini', 'Initials': 'H', 'LastName': 'Manji', 'Affiliation': 'Department of Neuroscience, Janssen Research and Development LLC, Titusville, New Jersey.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Department of Neuroscience, Janssen Research and Development LLC, San Diego, California.'}, {'ForeName': 'Jaskaran B', 'Initials': 'JB', 'LastName': 'Singh', 'Affiliation': 'Department of Neuroscience, Janssen Research and Development LLC, San Diego, California.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.1189']
601,31796827,Expanding the parameter space of anodal transcranial direct current stimulation of the primary motor cortex.,"Size and duration of the neuroplastic effects of tDCS depend on stimulation parameters, including stimulation duration and intensity of current. The impact of stimulation parameters on physiological effects is partially non-linear. To improve the utility of this intervention, it is critical to gather information about the impact of stimulation duration and intensity on neuroplasticity, while expanding the parameter space to improve efficacy. Anodal tDCS of 1-3 mA current intensity was applied for 15-30 minutes to study motor cortex plasticity. Sixteen healthy right-handed non-smoking volunteers participated in 10 sessions (intensity-duration pairs) of stimulation in a randomized cross-over design. Transcranial magnetic stimulation (TMS)-induced motor-evoked potentials (MEP) were recorded as outcome measures of tDCS effects until next evening after tDCS. All active stimulation conditions enhanced motor cortex excitability within the first 2 hours after stimulation. We observed no significant differences between the three stimulation intensities and durations on cortical excitability. A trend for larger cortical excitability enhancements was however observed for higher current intensities (1 vs 3 mA). These results add information about intensified tDCS protocols and suggest that the impact of anodal tDCS on neuroplasticity is relatively robust with respect to gradual alterations of stimulation intensity, and duration.",2019,We observed no significant differences between the three stimulation intensities and durations on cortical excitability.,['Sixteen healthy right-handed non-smoking volunteers'],"['Transcranial magnetic stimulation (TMS)-induced motor-evoked potentials (MEP', 'tDCS']","['stimulation duration and intensity of current', 'cortical excitability', 'motor cortex excitability']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0026607', 'cui_str': 'Somatomotor Areas'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}]",16.0,0.0447522,We observed no significant differences between the three stimulation intensities and durations on cortical excitability.,"[{'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Agboada', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mosayebi Samani', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Jamil', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Min-Fang', 'Initials': 'MF', 'LastName': 'Kuo', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany. nitsche@ifado.de.'}]",Scientific reports,['10.1038/s41598-019-54621-0']
602,31683023,Modified Biofeedback (Conditioned Biofeedback) Promotes Antinociception by Increasing the Nociceptive Flexion Reflex Threshold and Reducing Temporal Summation of Pain: A Controlled Trial.,"This study examined whether a modified version of biofeedback (ie, Conditioned Biofeedback) that incorporated placebo analgesia-like manipulations could promote antinociception in healthy, pain-free participants. During Conditioned Biofeedback (n = 28), sympathetic arousal level was displayed visually and participants were asked to reduce it while they received painful electric stimulations that were surreptitiously controlled by their arousal level. Thus, electric pain decreased as arousal decreased to associate successful arousal-reduction/relaxation with pain relief, and to promote expectations for future pain relief. A Biofeedback Only group (n = 24) controlled for the general effects of biofeedback/relaxation. A Biofeedback+Shock group (n = 21) controlled for the effects of practicing biofeedback during painful shocks. Nociceptive flexion reflex (NFR) threshold and temporal summation of pain (TS-pain) were used to assess changes in spinal nociception and pain facilitation, respectively. Results indicated all groups showed pre- to postbiofeedback increases in NFR threshold, but only the Conditioned Biofeedback group showed pre- to postbiofeedback reductions in TS-pain. Moreover, Conditioned Biofeedback resulted in a persistent (prebiofeedback) increase in NFR threshold across sessions, whereas Biofeedback Only resulted in a persistent (prebiofeedback) decrease in TS-pain. In sum, Conditioned Biofeedback may promote antinociception in healthy participants thus reducing risk for chronic pain. The study was registered prospectively on ClinicalTrials.gov (TU1560). PERSPECTIVE: A modified version of biofeedback that employs placebo analgesia manipulations was successful in increasing descending inhibition and reducing pain facilitation in healthy volunteers. As a result, it may be an effective means of reducing risk of future chronic pain onset by promoting an antinociceptive pain profile.",2020,A modified version of biofeedback that employs placebo analgesia manipulations was successful in increasing descending inhibition and reducing pain facilitation in healthy volunteers.,"['healthy, pain-free participants', 'healthy participants', 'healthy volunteers']","['placebo analgesia-like manipulations', 'Conditioned Biofeedback', 'practicing biofeedback', 'placebo analgesia manipulations', 'biofeedback/relaxation', 'modified version of biofeedback (ie, Conditioned Biofeedback', 'Biofeedback+Shock', 'Modified biofeedback (Conditioned Biofeedback']","['pain facilitation', 'electric pain', 'spinal nociception and pain facilitation', 'sympathetic arousal level', 'temporal summation of pain', 'TS-pain', 'Nociceptive flexion reflex (NFR) threshold and temporal summation of pain (TS-pain', 'NFR threshold']","[{'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation, function (observable entity)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1264664', 'cui_str': 'Number fraction'}]",,0.0847309,A modified version of biofeedback that employs placebo analgesia manipulations was successful in increasing descending inhibition and reducing pain facilitation in healthy volunteers.,"[{'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Rhudy', 'Affiliation': 'Department of Psychology, The University of Tulsa, Tulsa, Oklahoma. Electronic address: jamie-rhudy@utulsa.edu.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Hellman', 'Affiliation': 'Department of Psychology, The University of Tulsa, Tulsa, Oklahoma.'}, {'ForeName': 'Cassandra A', 'Initials': 'CA', 'LastName': 'Sturycz', 'Affiliation': 'Department of Psychology, The University of Tulsa, Tulsa, Oklahoma.'}, {'ForeName': 'Tyler A', 'Initials': 'TA', 'LastName': 'Toledo', 'Affiliation': 'Department of Psychology, The University of Tulsa, Tulsa, Oklahoma.'}, {'ForeName': 'Shreela', 'Initials': 'S', 'LastName': 'Palit', 'Affiliation': 'Department of Psychology, The University of Tulsa, Tulsa, Oklahoma; Pain Research and Intervention Center of Excellence, University of Florida, Gainesville, Florida.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.10.006']
603,31780765,Pharmacogenetics of amfepramone in healthy Mexican subjects reveals potential markers for tailoring pharmacotherapy of obesity: results of a randomised trial.,"Amfepramone (AFP) is an appetite-suppressant drug used in the treatment of obesity. Nonetheless, studies on interindividual pharmacokinetic variability and its association with genetic variants are limited. We employed a pharmacokinetic and pharmacogenetic approach to determine possible metabolic phenotypes of AFP and identify genetic markers that could affect the pharmacokinetic variability in a Mexican population. A controlled, randomized, crossover, single-blind, two-treatment, two-period, and two sequence clinical study of AFP (a single 75 mg dose) was conducted in 36 healthy Mexican volunteers who fulfilled the study requirements. Amfepramone plasma levels were measured using high-performance liquid chromatography mass spectrometry. Genotyping was performed using real-time PCR with TaqMan probes. Four AFP metabolizer phenotypes were found in our population: slow, normal, intermediate, and fast. Additionally, two gene polymorphisms, ABCB1-rs1045642 and CYP3A4-rs2242480, had a significant effect on AFP pharmacokinetics (P < 0.05) and were the predictor factors in a log-linear regression model. The ABCB1 and CYP3A4 gene polymorphisms were associated with a fast metabolizer phenotype. These results suggest that metabolism of AFP in the Mexican population is variable. In addition, the genetic variants ABCB1-rs1045642 and CYP3A4-rs2242480 may partially explain the AFP pharmacokinetic variability.",2019,The ABCB1 and CYP3A4 gene polymorphisms were associated with a fast metabolizer phenotype.,"['healthy Mexican subjects', 'Mexican population', '36 healthy Mexican volunteers who fulfilled the study requirements']","['AFP', 'amfepramone', 'Amfepramone (AFP']","['Amfepramone plasma levels', 'AFP pharmacokinetics']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0012201', 'cui_str': 'amfepramone'}]","[{'cui': 'C0012201', 'cui_str': 'amfepramone'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",36.0,0.0420168,The ABCB1 and CYP3A4 gene polymorphisms were associated with a fast metabolizer phenotype.,"[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Gómez-Silva', 'Affiliation': 'Forensic Medicine Service, School of Medicine, Autonomous University of Nuevo Leon, Monterrey, Nuevo Leon, Mexico.'}, {'ForeName': 'Everardo', 'Initials': 'E', 'LastName': 'Piñeyro-Garza', 'Affiliation': 'Clinical Department of the Research Institute for Clinical and Experimental Pharmacology, Ipharma S.A, Monterrey, Nuevo Leon, Mexico.'}, {'ForeName': 'Rigoberto', 'Initials': 'R', 'LastName': 'Vargas-Zapata', 'Affiliation': 'Quality Assurance Department of the Research Institute for Clinical and Experimental Pharmacology, Ipharma S.A, Monterrey, Nuevo Leon, Mexico.'}, {'ForeName': 'María Elena', 'Initials': 'ME', 'LastName': 'Gamino-Peña', 'Affiliation': 'Statistical Department of the Research Institute for Clinical and Experimental Pharmacology, Ipharma S.A, Monterrey, Nuevo Leon, Mexico.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'León-García', 'Affiliation': 'Pharmaceutical Research S.A, Mexico City, CDMX, Mexico.'}, {'ForeName': 'Mario Bermúdez', 'Initials': 'MB', 'LastName': 'de León', 'Affiliation': 'Department of Molecular Biology, Center for Biomedical Research of the Northeast, Mexican Institute of Social Security, Monterrey, Nuevo Leon, Mexico.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Llerena', 'Affiliation': 'Clinical Research Center of Health Area, Hospital and Medical School of Extremadura University, Badajoz, Spain.'}, {'ForeName': 'Rafael B R', 'Initials': 'RBR', 'LastName': 'León-Cachón', 'Affiliation': 'Center of Molecular Diagnostics and Personalized Medicine, Department of Basic Sciences, Division of Health Sciences, University of Monterrey, San Pedro Garza Garcia, Nuevo Leon, Mexico. rafael.reyesleon@udem.edu.'}]",Scientific reports,['10.1038/s41598-019-54436-z']
604,31784704,Efficacy and safety of subthreshold micropulse laser compared with threshold conventional laser in central serous chorioretinopathy.,"PURPOSE
To compare the efficacy and safety of subthreshold micropulse laser (SML) with threshold conventional laser (TCL) in central serous chorioretinopathy (CSC).
METHODS
Prospective, randomized, double-masked, non-inferiority, 12-week clinical trial. Patients were randomly assigned 1:1 to SML group or TCL group. Patients in the SML group were treated with 577 nm micropulse laser. The spot size was 160 µm, the duty cycle was 5% and exposure time was 0.2 s. The power was 50% threshold tested. Patients in the TCL group were treated with 577 nm continuous laser. The power was 100% threshold tested. The primary outcome was the mean change in best-corrected visual acuity (BCVA) at week 12, with a non-inferiority limit of five letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts.
RESULTS
Eighty-eight patients were enroled. Seventy-seven patients were male. Forty-four patients were in SML group and 44 in TCL group. At week 12, SML was equivalent to TCL with a gain of 6.23 ± 8.59 and 6.61 ± 6.35 letters, respectively, (SML-TCL difference: -0.38 letters; 95% confidence interval (CI):-3.58-2.81; P non-inferiority = 0.0026). There was no statistically significant difference between the two groups (t = 0.240, P = 0.811). At week 12, the proportion of patients whose SRF had been totally absorbed was 63.63 and 81.82% respectively for SML and TCL groups. There was no statistically significant difference between the two groups (χ 2 = 3.67, P = 0.056).
CONCLUSIONS
Both SML and TCL can improve visual acuity in CSC. SML was non-inferior to TCL in the improvement of BCVA.",2020,"There was no statistically significant difference between the two groups (χ 2 = 3.67, P = 0.056).
","['Forty-four patients were in SML group and 44 in TCL group', 'Eighty-eight patients were enroled', 'central serous chorioretinopathy (CSC', 'Seventy-seven patients were male', 'central serous chorioretinopathy']","['subthreshold micropulse laser compared with threshold conventional laser', 'subthreshold micropulse laser (SML) with threshold conventional laser (TCL', 'TCL', '577\u2009nm continuous laser', '577\u2009nm micropulse laser', 'SML group or TCL', 'SML', 'SML and TCL']","['spot size', 'efficacy and safety', 'mean change in best-corrected visual acuity (BCVA', 'Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts', 'Efficacy and safety', 'visual acuity']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0730328', 'cui_str': 'Central Serous Retinopathy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0183370', 'cui_str': 'Snellen eye chart'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",88.0,0.177868,"There was no statistically significant difference between the two groups (χ 2 = 3.67, P = 0.056).
","[{'ForeName': 'Zuhua', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Chaochao', 'Initials': 'C', 'LastName': 'Nie', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Pei', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Junyan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Bothwin Clinical Study Consultant, Redmond, WA, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Chong', 'Affiliation': 'Optegra Eye Hospital, London, UK.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China. drliuxiaolin@163.com.'}]","Eye (London, England)",['10.1038/s41433-019-0692-8']
605,31772100,Finnish Trial on Practices of Anterior Cervical Decompression and Fusion (FACADE): a protocol for a prospective randomised non-inferiority trial comparing outpatient versus inpatient care.,"INTRODUCTION
Although a great majority of patients with cervical radiculopathy syndrome can successfully be treated non-operatively, a considerable proportion experience persistent symptoms, severe enough to require neurosurgical intervention. During the past decade, cervical spine procedures have increasingly been performed on an outpatient basis and retrospective database analyses have shown this to be feasible and safe. However, there are no randomised controlled studies comparing outpatient care with inpatient care, particularly with emphasis on the patients' perception of symptom relief and their ability to return to normal daily activities and work.
METHODS AND ANALYSIS
This is a prospective, randomised, controlled, parallel group non-inferiority trial comparing the traditional hospital surveillance (inpatient, patients staying in the hospital for 1-3 nights after surgery) with outpatient care (discharge on the day of the surgery, usually within 6-8 hours after procedure) in patients who have undergone anterior cervical decompression and fusion procedure. To determine whether early discharge (outpatient care) is non-inferior to inpatient care, we will randomise 104 patients to these two groups and follow them for 6 months using the Neck Disability Index (NDI) as the primary outcome. We expect that early discharge is not significantly worse than the current care in terms of change in NDI. Non-inferiority will be declared if the mean improvement for outpatient care is no worse than the mean improvement for inpatient care, by a margin of 17.3%. We hypothesise that a shorter hospital stay results in more rapid return to normal daily activities, shorter duration of sick leave and decreased secondary costs to healthcare system. Secondary outcomes in our study are arm pain and neck pain using the Numeric Rating Scale, operative success (Odom's criteria), patient's satisfaction to treatment, general quality of life (EQ-5D-5L), Work Ability Score, sickness absence days, return to previous leisure activities and complications.
ETHICS AND DISSEMINATION
The study was approved by the institutional review board of the Helsinki and Uusimaa Hospital District on 6 June 2019 (1540/2019) and duly registered at ClinicalTrials.gov. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER
NCT03979443.",2019,"We expect that early discharge is not significantly worse than the current care in terms of change in NDI. Non-inferiority will be declared if the mean improvement for outpatient care is no worse than the mean improvement for inpatient care, by a margin of 17.3%.","['Helsinki and Uusimaa Hospital District on 6 June 2019 (1540/2019) and duly registered at ClinicalTrials.gov', 'patients with cervical radiculopathy syndrome', 'inpatient, patients staying in the hospital for 1-3 nights after surgery) with outpatient care (discharge on the day of the surgery, usually within 6-8\u2009hours after procedure) in patients who have undergone anterior cervical decompression and fusion procedure']","['traditional hospital surveillance', 'Anterior Cervical Decompression and Fusion (FACADE']","['Neck Disability Index (NDI', ""arm pain and neck pain using the Numeric Rating Scale, operative success (Odom's criteria), patient's satisfaction to treatment, general quality of life (EQ-5D-5L), Work Ability Score, sickness absence days, return to previous leisure activities and complications"", 'duration of sick leave']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0742186', 'cui_str': 'Radiculopathy, Cervical'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1292429', 'cui_str': '8 hours (qualifier value)'}, {'cui': 'C0580203', 'cui_str': 'Postprocedural period (qualifier value)'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}]","[{'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0222045'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}]",104.0,0.1606,"We expect that early discharge is not significantly worse than the current care in terms of change in NDI. Non-inferiority will be declared if the mean improvement for outpatient care is no worse than the mean improvement for inpatient care, by a margin of 17.3%.","[{'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Lönnrot', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland kimmo.lonnrot@hus.fi.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Toivonen', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Aronen', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Anniina', 'Initials': 'A', 'LastName': 'Koski-Palken', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Janek', 'Initials': 'J', 'LastName': 'Frantzen', 'Affiliation': 'Division of Clinical neurosciences, Department of Neurosurgery, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Leinonen', 'Affiliation': 'Department of Neurosurgery, Kuopio University Hospital and University of Eastern Finland, Kys, Finland.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Silvasti-Lundell', 'Affiliation': 'Division of Anaesthesiology, Department of Anaesthesiology, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Förster', 'Affiliation': 'Department of Anaesthesia, Orthopaedic Hospital Orton, Helsinki, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Jarvinen', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-032575']
606,30346543,A randomized controlled trial to improve engagement of hospitalized patients with their patient portals.,"Objectives
To test a patient-centered, tablet-based bedside educational intervention in the hospital and to evaluate the efficacy of this intervention to increase patient engagement with their patient portals during hospitalization and after discharge.
Materials and Methods
We conducted a randomized controlled trial of adult patients admitted to the hospitalist service in one large, academic medical center. All participants were supplied with a tablet computer for 1 day during their inpatient stay and assistance with portal registration and initial login as needed. Additionally, intervention group patients received a focused bedside education to demonstrate key functions of the portal and explain the importance of these functions to their upcoming transition to post-discharge care. Our primary outcomes were proportion of patients who logged into the portal and completed specific tasks after discharge. Secondary outcomes were observed ability to navigate the portal before discharge and self-reported patient satisfaction with bedside tablet use to access the portal.
Results
We enrolled 97 participants (50 intervention; 47 control); overall 57% logged into their portals ≥1 time within 7 days of discharge (58% intervention vs. 55% control). Mean number of logins was higher for the intervention group (3.48 vs. 2.94 control), and mean number of specific portal tasks performed was higher in the intervention group; however, no individual comparison reached statistical significance. Observed ability to login and navigate the portal in the hospital was higher for the intervention group (64% vs. 60% control), but only 1 specific portal task was significant (view provider messaging tab: 92% vs. 77% control, P = .04). Time needed to deliver the intervention was brief (<15 min for 80%), and satisfaction with the bedside tablet to access the portal was high in the intervention group (88% satisfied/very satisfied).
Conclusion
Our intervention was highly feasible and acceptable to patients, and we found a highly consistent, but statistically non-significant, trend towards higher inpatient engagement and post-discharge use of key portal functions among patients in the intervention group.",2018,"Mean number of logins was higher for the intervention group (3.48 vs. 2.94 control), and mean number of specific portal tasks performed was higher in the intervention group; however, no individual comparison reached statistical significance.","['adult patients admitted to the hospitalist service in one large, academic medical center', 'hospitalized patients with their patient portals', 'We enrolled 97 participants (50 intervention; 47 control); overall 57% logged into their portals ≥1 time within 7 days of discharge (58% intervention vs. 55% control']","['bedside education', 'patient-centered, tablet-based bedside educational intervention']","['ability to navigate the portal before discharge and self-reported patient satisfaction with bedside tablet use to access the portal', 'Observed ability to login and navigate the portal in the hospital', 'specific portal task', 'proportion of patients who logged into the portal and completed specific tasks', 'inpatient engagement and post-discharge use of key portal functions', 'mean number of specific portal tasks', 'Mean number of logins']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600620', 'cui_str': 'Hospitalists'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",97.0,0.0847673,"Mean number of logins was higher for the intervention group (3.48 vs. 2.94 control), and mean number of specific portal tasks performed was higher in the intervention group; however, no individual comparison reached statistical significance.","[{'ForeName': 'S Ryan', 'Initials': 'SR', 'LastName': 'Greysen', 'Affiliation': 'Section of Hospital Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Harrison', 'Affiliation': 'Division of Hospital Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Rareshide', 'Affiliation': 'Center for Health Care Innovation, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Yimdriuska', 'Initials': 'Y', 'LastName': 'Magan', 'Affiliation': 'School of Medicine, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Seghal', 'Affiliation': 'School of Public Health, University of Maryland, College Park, College Park, MD, USA.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Rosenthal', 'Affiliation': 'School of Medicine, Boston University, Boston, MA, USA, and.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Jacolbia', 'Affiliation': 'School of Nursing, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Auerbach', 'Affiliation': 'Division of Hospital Medicine, University of California San Francisco, San Francisco, CA, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocy125']
607,31771038,The effectiveness of knee osteoarthritis treatment by arthroscopic microfracture technique in combination with autologous bone marrow stem cells transplantation.,"OBJECTIVE
We aimed to evaluate the efficacy of the treatment of knee osteoarthritis (OA) patients by using microfracture technique in combination with autologous bone marrow stem cell transplantation.
METHODS
A clinical study was conducted between November 2011 and January 2015 and involved 46 patients (aged from 46 to 69) with primary knee OA grade II and III (according to Kellgren-Lawrence classification) at the Orthopedic Trauma Department, Vietnam-Germany Friendship Hospital. Patients were randomly assigned to receive knee arthroscopy and then bone-marrow stem cells from their pelvic bones via injection.
RESULTS
The mean Visual Analogue Scale (VAS) score of present pain decreased from 5.68 before surgery to 1.7 24 months after surgery. The mean preoperative Knee Injury and Osteoarthritis Outcome Score (KOOS) was 36.34 (± 3.13), which increased to 74.62 (± 2.86) 24 months after surgery. On the MRI scans, the average Noyes score decreased from 12 (± 1.46) to 7 (± 1.50). Cartilage volume increased on average from 0.4512 (± 0.26) cm3 to 0.5463 (± 0.29) cm3 12-24 months after surgery.
CONCLUSION
Treatment of osteoarthritis by a combination of arthroscopic microfracture and transplantation of autologous bone-marrow stem cells was an invasive, safe and effective method which showed an improvement in the clinical symptoms (VAS score) and knee functions (KOOS points).",2020,"Cartilage volume increased on average from 0.4512 (± 0.26) cm3 to 0.5463 (± 0.29) cm3 12-24 months after surgery.
","['knee osteoarthritis (OA) patients', 'November 2011 and January 2015 and involved 46 patients (aged from 46 to 69) with primary knee OA grade II and III (according to Kellgren-Lawrence classification) at the Orthopedic Trauma Department, Vietnam-Germany Friendship Hospital']","['knee arthroscopy and then bone-marrow stem cells from their pelvic bones via injection', 'arthroscopic microfracture technique', 'arthroscopic microfracture and transplantation of autologous bone-marrow stem cells', 'microfracture technique in combination with autologous bone marrow stem cell transplantation', 'autologous bone marrow stem cells transplantation']","['average Noyes score', 'clinical symptoms (VAS score) and knee functions (KOOS points', 'mean preoperative Knee Injury and Osteoarthritis Outcome Score (KOOS', 'Cartilage volume', 'mean Visual Analogue Scale (VAS) score of present pain']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C3887652', 'cui_str': 'Pelvic Bones'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1265651', 'cui_str': 'Micro Fractures'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",46.0,0.0242667,"Cartilage volume increased on average from 0.4512 (± 0.26) cm3 to 0.5463 (± 0.29) cm3 12-24 months after surgery.
","[{'ForeName': 'Duong Dinh', 'Initials': 'DD', 'LastName': 'Toan', 'Affiliation': 'Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'Nguyen Thanh', 'Initials': 'NT', 'LastName': 'Binh', 'Affiliation': '108 Military Central Hospital, Vietnam.'}, {'ForeName': 'Tran Trung', 'Initials': 'TT', 'LastName': 'Dung', 'Affiliation': 'Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'Luu Quang', 'Initials': 'LQ', 'LastName': 'Thuy', 'Affiliation': 'Viet Duc Hospital, Vietnam.'}, {'ForeName': 'Nguyen Dinh', 'Initials': 'ND', 'LastName': 'Hoa', 'Affiliation': 'Viet Duc Hospital, Vietnam.'}, {'ForeName': 'Nguyen Hoang', 'Initials': 'NH', 'LastName': 'Long', 'Affiliation': 'Viet Duc Hospital, Vietnam.'}, {'ForeName': 'Pham Son', 'Initials': 'PS', 'LastName': 'Tung', 'Affiliation': 'Saint Paul University Hospital, Hanoi, Vietnam.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-191665']
608,31784702,Observation of topical tacrolimus on high-risk penetrating keratoplasty patients: a randomized clinical trial study.,"BACKGROUND/OBJECTIVES
To evaluate the clinical efficacy of topical tacrolimus 0.1% and cyclosporine 1% on high-risk penetrating keratoplasty (PKP) patients.
SUBJECTS/METHODS
A series of 49 high-risk PKP patients (49 eyes), 20 males, 29 females from the age of 4 months to 74 years of age with the mean of 32.5 from 2012 to 2017 were recruited in this study. The patients were randomly divided into two groups by receiving either topical tacrolimus 0.1% or cyclosporine 1% respectively. Twenty five patients were treated with topical tacrolimus 0.1% and 24 patients with topical cyclosporine 1%. The traditional baseline management on these two groups were Tobramycin and Dexamethasone eye drops in the first 3 weeks and then tapered off. Clinical procedures and postoperative follow-up were documented.
RESULTS
After 6-54 months follow-up, with the average of 24 months, 11 of 24 high-risk patients (11 eyes) had graft rejection, the rejection rate was 45.8% in topical cyclosporine 1% group. The rejections occurred from 35 days to 20 months after PKP. Three patients had irreversible rejection. On topical tacrolimus 0.1% group, the rejection occurred in four patients (four eyes) with rejection rate of 16%, and no irreversible rejection was observed. The graft rejection episodes were documented between 23 days and 24 months. As compared with the topical cyclosporine 1%, topical tacrolimus 0.1%, a key immunosuppressant, significantly decreased corneal graft rejection rate (p = 0.02).
CONCLUSIONS
Topical tacrolimus 01% on high-risk PKP patients significantly prevented corneal graft rejection, and it had less adverse effects and was very safe to high-risk patients as to topical cyclosporine 1%. Further case controlled randomized clinical trial studies are needed to establish the best management option for these high-risk patients.",2020,"On topical tacrolimus 0.1% group, the rejection occurred in four patients (four eyes) with rejection rate of 16%, and no irreversible rejection was observed.","['49 high-risk PKP patients (49 eyes), 20 males, 29 females from the age of 4 months to 74 years of age with the mean of 32.5 from 2012 to 2017 were recruited in this study', 'high-risk penetrating keratoplasty (PKP) patients', 'high-risk penetrating keratoplasty patients', 'Twenty five patients were treated with']","['topical cyclosporine', 'Topical tacrolimus', 'topical tacrolimus', 'Tobramycin and Dexamethasone', 'topical tacrolimus 0.1% or cyclosporine', 'cyclosporine']","['rejection rate', 'graft rejection, the rejection rate', 'graft rejection episodes', 'rejections', 'corneal graft rejection', 'rejection', 'irreversible rejection', 'corneal graft rejection rate', 'adverse effects']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517710', 'cui_str': '32.5 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0022592', 'cui_str': 'Keratoplasty, Penetrating'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0018129', 'cui_str': 'Transplantation Rejection'}, {'cui': 'C0877542', 'cui_str': 'Graft rejection episode'}, {'cui': 'C0339303', 'cui_str': 'Corneal graft rejection (disorder)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",2017.0,0.0279068,"On topical tacrolimus 0.1% group, the rejection occurred in four patients (four eyes) with rejection rate of 16%, and no irreversible rejection was observed.","[{'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Zhai', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China.'}, {'ForeName': 'Xiao-Rong', 'Initials': 'XR', 'LastName': 'Zhang', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China. zxr1110@sina.com.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China.'}, {'ForeName': 'Hong-Chang', 'Initials': 'HC', 'LastName': 'Xu', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China.'}]","Eye (London, England)",['10.1038/s41433-019-0717-3']
609,31687769,Impact of Smoking Cessation Interventions Initiated During Hospitalization Among HIV-Infected Smokers.,"INTRODUCTION
Smoking is a key determinant of mortality among people living with HIV (PLWH).
METHODS
To better understand the effects of smoking cessation interventions in PLWH, we conducted a pooled analysis of four randomized controlled trials of hospital-initiated smoking interventions conducted through the Consortium of Hospitals Advancing Research on Tobacco (CHART). In each study, cigarette smokers were randomly assigned to usual care or a smoking cessation intervention. The primary outcome was self-reported past 30-day tobacco abstinence at 6-month follow-up. Abstinence rates were compared between PLWH and participants without HIV and by treatment arm, using both complete-case and intention-to-treat analyses. Multivariable logistic regression was used to determine the effect of HIV status on 6-month tobacco abstinence and to determine predictors of smoking cessation within PLWH.
RESULTS
Among 5550 hospitalized smokers, there were 202 (3.6%) PLWH. PLWH smoked fewer cigarettes per day and were less likely to be planning to quit than smokers without HIV. At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%). In multivariable regression analysis, HIV status was not significantly associated with smoking cessation at 6 months. Among PLWH, confidence in quitting was the only clinical factor independently associated with smoking cessation (OR 2.0, 95% CI = 1.4 to 2.8, p < .01).
CONCLUSIONS
HIV status did not alter likelihood of quitting smoking after hospital discharge, whether or not the smoker was offered a tobacco cessation intervention, but power was limited to identify potentially important differences.
IMPLICATIONS
PLWH had similar quit rates to participants without HIV following a hospital-initiated smoking cessation intervention. The findings suggest that factors specific to HIV infection may not influence response to smoking cessation interventions and that all PLWH would benefit from efforts to assist in quitting smoking.
TRIAL REGISTRATION
(1) Using ""warm handoffs"" to link hospitalized smokers with tobacco treatment after discharge: study protocol of a randomized controlled trial: NCT01305928. (2) Web-based smoking cessation intervention that transitions from inpatient to outpatient: NCT01277250. (3) Effectiveness of smoking-cessation interventions for urban hospital patients: NCT01363245. (4) Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (HelpingHAND2): NCT01714323.",2020,"At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%).","['Hospitalized Smokers (HelpingHAND2', 'people living with HIV (PLWH', '5550 hospitalized smokers', 'hospitalized smokers with tobacco treatment after discharge', 'hospital-initiated smoking interventions conducted through the Consortium of Hospitals Advancing Research on Tobacco (CHART', 'HIV-Infected Smokers', 'participants without HIV following a hospital-initiated smoking cessation intervention', 'urban hospital patients', 'cigarette smokers']","['usual care or a smoking cessation intervention', 'Post-Discharge Strategies', 'PLWH', 'smoking-cessation interventions', 'Smoking Cessation Interventions']","['Abstinence rates', 'smoking cessation', 'self-reported past 30-day tobacco abstinence', 'cessation rates', 'quit rates']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0035168'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0020029', 'cui_str': 'Hospitals, Metropolitan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]",,0.0487106,"At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%).","[{'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Triant', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Grossman', 'Affiliation': 'Cambridge Health Alliance, Somerville, MA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Ramachandran', 'Affiliation': 'Division of Preventive Medicine, School of Medicine, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Kimber P', 'Initials': 'KP', 'LastName': 'Richter', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, Kansas, Nashville, TN.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Division of General Internal Medicine and Public Health, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Harrington', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, School of Medicine, University of Alabama, Birmingham, AL.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz168']
610,31057137,The use of a self-check-in kiosk for early patient identification and queuing in the emergency department.,"OBJECTIVE
Delays in triage processes in the emergency department (ED) can compromise patient safety. The aim of this study was to provide proof-of-concept that a self-check-in kiosk could decrease the time needed to identify ambulatory patients arriving in the ED. We compared the use of a novel automated self-check-in kiosk to identify patients on ED arrival to routine nurse-initiated patient identification.
METHODS
We performed a prospective trail with random weekly allocation to intervention or control processes during a 10-week study period. During intervention weeks, patients used a self-check-in kiosk to self-identify on arrival. This electronically alerted triage nurses to patient arrival times and primary complaint before triage. During control weeks, kiosks were unavailable and patients were identified using routine nurse-initiated triage. The primary outcome was time-to-first-identification, defined as the interval between ED arrival and identification in the hospital system.
RESULTS
Median (interquartile range) time-to-first-identification was 1.4 minutes (1.0-2.08) for intervention patients and 9 minutes (5-18) for control patients. Regression analysis revealed that the adjusted time-to-first-identification was 13.6 minutes (95% confidence interval 12.8-14.5) faster for the intervention group.
CONCLUSION
A self-check-in kiosk significantly reduced the time-to-first-identification for ambulatory patients arriving in the ED.",2019,"Regression analysis revealed that the adjusted time-to-first-identification was 13.6 minutes (95% confidence interval 12.8-14.5) faster for the intervention group.
",[],[],"['time-to-first-identification, defined as the interval between ED arrival and identification in the hospital system']",[],[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",,0.0344722,"Regression analysis revealed that the adjusted time-to-first-identification was 13.6 minutes (95% confidence interval 12.8-14.5) faster for the intervention group.
","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Coyle', 'Affiliation': 'Department of Emergency Medicine, Sunnybrook Health Sciences Centre, Toronto, ON.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kennedy', 'Affiliation': 'Department of Emergency Medicine, Sunnybrook Health Sciences Centre, Toronto, ON.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Schull', 'Affiliation': 'Department of Emergency Medicine, Sunnybrook Health Sciences Centre, Toronto, ON.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Hefferon', 'Affiliation': 'Department of Emergency Medicine, Sunnybrook Health Sciences Centre, Toronto, ON.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sinclair', 'Affiliation': 'Department of Emergency Medicine, Sunnybrook Health Sciences Centre, Toronto, ON.'}, {'ForeName': 'Zuhair', 'Initials': 'Z', 'LastName': 'Alsharafi', 'Affiliation': 'Department of Emergency Medicine, Sunnybrook Health Sciences Centre, Toronto, ON.'}]",CJEM,['10.1017/cem.2019.349']
611,31755310,Dietary Practices and Meal Patterns among Overweight and Obese School Children in Malaysia: Baseline Data from a School-Based Intervention Study.,"This study aimed to determine dietary practices and meal patterns among Malaysian overweight and obese school children at baseline. This study was part of a school-based obesity intervention study, My Body is Fit and Fabulous at School (MyBFF@school). It involved 1045 primary and 1041 secondary overweight and obese school children from a randomly selected 23 out of 1196 primary and 15 out of 416 secondary government schools in central Peninsular Malaysia. The results showed a significantly higher of adequate intake (4-8 servings/day) of cereals and grains among primary (54.7%) than secondary school children (48.2%). About 28.2% of primary and 32.6% of secondary school children had consumed adequate fruit (2 servings/day), while a very low percentage of both primary (5.0%) and secondary (3.6%) school children consumed adequate vegetables (3 servings/day). As for the meal patterns, school children in both primary and secondary were not taking breakfast regularly (mean±SD for primary: 3.16 ± 2.61 days/week vs secondary: 2.97 ± 2.52 days/week). There was also a significantly higher mean frequency of primary school children brought plain water to school than the secondary school children. In conclusion, urgent actions to address improper dietary practices and meal patterns of overweight and obese school children in Malaysia are warranted.",2020,The results showed a significantly higher of adequate intake (4-8 servings/day) of cereals and grains among primary (54.7%) than secondary school children (48.2%).,"['1045 primary and 1041 secondary overweight and obese school children from a randomly selected 23 out of 1196 primary and 15 out of 416 secondary government schools in central Peninsular Malaysia', 'overweight and obese school children in Malaysia', 'Malaysian overweight and obese school children at baseline', 'Overweight and Obese School Children in Malaysia']",[],['adequate intake'],"[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454750', 'cui_str': 'Peninsular Malaysia (geographic location)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}]",[],"[{'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}]",1196.0,0.014681,The results showed a significantly higher of adequate intake (4-8 servings/day) of cereals and grains among primary (54.7%) than secondary school children (48.2%).,"[{'ForeName': 'Rusidah', 'Initials': 'R', 'LastName': 'Selamat', 'Affiliation': 'Nutrition Division, Ministry of Health Malaysia , Putrajaya, Malaysia.'}, {'ForeName': 'Junidah', 'Initials': 'J', 'LastName': 'Raib', 'Affiliation': 'Nutrition Division, Ministry of Health Malaysia , Putrajaya, Malaysia.'}, {'ForeName': 'Nur Azlina', 'Initials': 'NA', 'LastName': 'Abdul Aziz', 'Affiliation': 'Nutrition Division, Ministry of Health Malaysia , Putrajaya, Malaysia.'}, {'ForeName': 'Norlida', 'Initials': 'N', 'LastName': 'Zulkafly', 'Affiliation': 'Nutrition Division, Ministry of Health Malaysia , Putrajaya, Malaysia.'}, {'ForeName': 'Ainan Nasrina', 'Initials': 'AN', 'LastName': 'Ismail', 'Affiliation': 'Nutrition Division, Ministry of Health Malaysia , Putrajaya, Malaysia.'}, {'ForeName': 'W Nurul Ashikin', 'Initials': 'WNA', 'LastName': 'W Mohamad', 'Affiliation': 'Nutrition Division, Ministry of Health Malaysia , Putrajaya, Malaysia.'}, {'ForeName': 'Nur Izzatun Nasriah', 'Initials': 'NIN', 'LastName': 'Nasruddin', 'Affiliation': 'Nutrition Division, Ministry of Health Malaysia , Putrajaya, Malaysia.'}, {'ForeName': 'Muhammad Yazid', 'Initials': 'MY', 'LastName': 'Jalaludin', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Malaya , Kuala Lumpur, Malaysia.'}, {'ForeName': 'Fuziah', 'Initials': 'F', 'LastName': 'Md Zain', 'Affiliation': 'Paediatric Department, Putrajaya Hospital, Ministry of Health Malaysia , Putrajaya, Malaysia.'}, {'ForeName': 'Zahari', 'Initials': 'Z', 'LastName': 'Ishak', 'Affiliation': 'Department of Educational Psychology and Counseling, Faculty of Education, University of Malaya , Kuala Lumpur, Malaysia.'}, {'ForeName': 'Abqariyah', 'Initials': 'A', 'LastName': 'Yahya', 'Affiliation': 'Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya , Kuala Lumpur, Malaysia.'}, {'ForeName': 'Abdul Halim', 'Initials': 'AH', 'LastName': 'Mokhtar', 'Affiliation': 'Department of Sport Sciences, Faculty of Medicine, University of Malaya , Kuala Lumpur, Malaysia.'}]",Ecology of food and nutrition,['10.1080/03670244.2019.1694922']
612,32492104,Exercise Electrocardiography and Computed Tomography Coronary Angiography for Patients With Suspected Stable Angina Pectoris: A Post Hoc Analysis of the Randomized SCOT-HEART Trial.,"Importance
Recent European guidance supports a diminished role for exercise electrocardiography (ECG) in the assessment of suspected stable angina.
Objective
To evaluate the utility of exercise ECG in contemporary practice and assess the value of combined functional and anatomical testing.
Design, Setting, and Participants
This is a post hoc analysis of the Scottish Computed Tomography of the Heart (SCOT-HEART) open-label randomized clinical trial, conducted in 12 cardiology chest pain clinics across Scotland for patients with suspected angina secondary to coronary heart disease. Between November 18, 2010, and September 24, 2014, 4146 patients aged 18 to 75 years with stable angina underwent clinical evaluation and 1417 of 1651 (86%) underwent exercise ECG prior to randomization. Statistical analysis was conducted from October 10 to November 5, 2019.
Interventions
Patients were randomized in a 1:1 ratio to receive standard care plus coronary computed tomography (CT) angiography or to receive standard care alone. The present analysis was limited to the 3283 patients who underwent exercise ECG alone or in combination with coronary CT angiography.
Main Outcomes and Measures
The primary clinical end point was death from coronary heart disease or nonfatal myocardial infarction at 5 years.
Results
Among the 3283 patients (1889 men; median age, 57.0 years [interquartile range, 50.0-64.0 years]), exercise ECG had a sensitivity of 39% and a specificity of 91% for detecting any obstructive coronary artery disease in those who underwent subsequent invasive angiography. Abnormal results of exercise ECG were associated with a 14.47-fold (95% CI, 10.00-20.41; P < .001) increase in coronary revascularization at 1 year and a 2.57-fold (95% CI, 1.38-4.63; P < .001) increase in mortality from coronary heart disease death at 5 years or in cases of nonfatal myocardial infarction at 5 years. Compared with exercise ECG alone, results of coronary CT angiography had a stronger association with 5-year coronary heart disease death or nonfatal myocardial infarction (hazard ratio, 10.63; 95% CI, 2.32-48.70; P = .002). The greatest numerical difference in outcome with CT angiography compared with exercise ECG alone was observed for those with inconclusive results of exercise ECG (6 of 283 [2%] vs 18 of 283 [6%]), although this was not statistically significant (log-rank P = .05).
Conclusions and Relevance
This study suggests that abnormal results of exercise ECG are associated with coronary revascularization and the future risk of adverse coronary events. However, coronary CT angiography more accurately detects coronary artery disease and is more strongly associated with future risk compared with exercise ECG.
Trial Registration
ClinicalTrials.gov Identifier: NCT01149590.",2020,"Compared with exercise ECG alone, results of coronary CT angiography had a stronger association with 5-year coronary heart disease death or nonfatal myocardial infarction (hazard ratio, 10.63; 95% CI, 2.32-48.70; P = .002).","['With Suspected Stable Angina Pectoris', 'Between November 18, 2010, and September 24, 2014, 4146 patients aged 18 to 75 years with stable angina underwent clinical evaluation and 1417 of 1651 (86%) underwent', 'Patients', '12 cardiology chest pain clinics across Scotland for patients with suspected angina secondary to coronary heart disease', '3283 patients who underwent', '3283 patients (1889 men; median age, 57.0 years [interquartile range, 50.0-64.0 years]), exercise ECG had a sensitivity of 39% and a specificity of 91% for detecting any obstructive coronary artery disease in those who underwent subsequent invasive angiography']","['coronary CT angiography', 'exercise ECG', 'Exercise Electrocardiography and Computed Tomography Coronary Angiography', 'exercise electrocardiography (ECG', 'exercise ECG alone or in combination with coronary CT angiography', 'CT angiography', 'standard care plus coronary computed tomography (CT) angiography or to receive standard care alone']","['mortality from coronary heart disease death', 'coronary revascularization', 'exercise ECG', 'death from coronary heart disease or nonfatal myocardial infarction at 5 years', '5-year coronary heart disease death or nonfatal myocardial infarction']","[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}]",4146.0,0.139474,"Compared with exercise ECG alone, results of coronary CT angiography had a stronger association with 5-year coronary heart disease death or nonfatal myocardial infarction (hazard ratio, 10.63; 95% CI, 2.32-48.70; P = .002).","[{'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Singh', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Bing', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Edwin J R', 'Initials': 'EJR', 'LastName': 'van Beek', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Villines', 'Affiliation': 'Division of Cardiovascular Medicine, University of Virginia, Charlottesville.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}]",JAMA cardiology,['10.1001/jamacardio.2020.1567']
613,31756536,Tandem Autologous-Autologous versus Autologous-Allogeneic Hematopoietic Stem Cell Transplant for Patients with Multiple Myeloma: Long-Term Follow-Up Results from the Blood and Marrow Transplant Clinical Trials Network 0102 Trial.,"Allogeneic hematopoietic cell transplant (HCT) may improve long-term multiple myeloma (MM) control through the graft-versus-myeloma effect. The Blood and Marrow Transplant Clinical Trials Network 0102 trial was a biologic assignment trial comparing tandem autologous transplant (auto-auto) versus autologous followed by reduced-intensity allogeneic (auto-allo) transplant in patients with newly diagnosed MM with standard-risk (n = 625) or high-risk (n = 85; β 2 -microglobulin at diagnosis ≥ 4 mg/dL or deletion of chromosome 13 by conventional karyotyping) disease. Although the initial 3-year analysis showed no difference in progression-free survival (PFS) between arms in either risk group, we hypothesized that long-term follow-up may better capture the impact of the graft-versus-myeloma effect. Median follow-up of survivors was over 10 years. Among standard-risk patients there was no difference in PFS (hazard ratio [HR], 1.11; 95% confidence interval [CI], .93 to 1.35; P = .25) or OS (HR, 1.03; 95% CI, .82 to 1.28; P = .82). The 6-year PFS was 25% in the auto-auto arm versus 22% in the auto-allo arm (P = .32), and 6-year overall survival (OS) was 60% and 59%, respectively (P = .85). In the high-risk group, although there was no statistically significant difference in PFS (HR, .66; 95% CI, .41 to 1.07; P = .07) and OS (HR, 1.01; 95% CI, .60 to 1.71; P = .96), a reduction in 6-year risk of relapse of 77% versus 47% (P = .005) was reflected in better PFS of 13% versus 31% (P = .05) but similar OS, at 47% versus 51% (P = .69). Allogeneic HCT can lead to long-term disease control in patients with high-risk MM and needs to be explored in the context of modern therapy.",2020,"Among standard risk patients there was no difference in PFS (HR 1.11, 95% C.I. 0.93- 1.35, P=0.25) or OS (HR 1.03, 95% C.I. 0.82-1.28, P=0.82).","['Patients with Multiple Myeloma', 'patients with high risk MM', 'patients with newly diagnosed MM with standard (N=625) or high-risk (beta 2 microglobulin at diagnosis ≥ 4 mg/dl or deletion of chromosome 13 by conventional karyotyping) disease (N=85']","['Tandem Autologous-Autologous versus Autologous-Allogeneic Hematopoietic Stem Cell Transplantation', 'tandem autologous transplant (auto-auto) vs. autologous followed by reduced intensity allogeneic (auto-allo) transplantation', 'Allogeneic HCT', 'Allogeneic hematopoietic cell transplantation (HCT']","['6-year PFS', 'progression-free survival (PFS', '6-year risk of relapse', '6-year overall survival (OS', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0201910', 'cui_str': 'Beta-2-microglobulin measurement (procedure)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}, {'cui': 'C0008655', 'cui_str': 'Chromosome 13'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0022526', 'cui_str': 'Karyotype Analysis Methods'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C0559189', 'cui_str': 'Autotransplants'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",625.0,0.209154,"Among standard risk patients there was no difference in PFS (HR 1.11, 95% C.I. 0.93- 1.35, P=0.25) or OS (HR 1.03, 95% C.I. 0.82-1.28, P=0.82).","[{'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Giralt', 'Affiliation': 'Adult Bone Marrow Transplant Service, Memorial Sloan Kettering Cancer Center, New York, New York. Electronic address: GiraltS@mskcc.org.'}, {'ForeName': 'Luciano J', 'Initials': 'LJ', 'LastName': 'Costa', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Maloney', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, Duarte, California.'}, {'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'Fei', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Antin', 'Affiliation': 'Division of Hematologic Malignancies, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Brunstein', 'Affiliation': 'Division of Hematology, Oncology and Transplantation, Department of Medicine, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Geller', 'Affiliation': 'National Institutes of Health-National Heart, Lung, and Blood Institute Government Agency Partners, Bethesda, Maryland.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': 'VA Tennessee Valley HCS HSCT Program Nashville, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Parameswaran', 'Initials': 'P', 'LastName': 'Hari', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Logan', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin; Division of Biostatistics, Institute for Health and Equity, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lowsky', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University Medical, Stanford, California.'}, {'ForeName': 'Muzaffar H', 'Initials': 'MH', 'LastName': 'Qazilbash', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, Division of Cancer Medicine, M.D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Sahebi', 'Affiliation': 'Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, Duarte, California.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Somlo', 'Affiliation': 'Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, Duarte, California.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rowley', 'Affiliation': 'John Theurer Cancer Center at Hackensack UMC, Hackensack, New Jersey; Lombardi Comprehensive Cancer Center, MedStar Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'Dan T', 'Initials': 'DT', 'LastName': 'Vogl', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Vesole', 'Affiliation': 'John Theurer Cancer Center at Hackensack UMC, Hackensack, New Jersey.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Pasquini', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Stadtmauer', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.11.018']
614,31757838,Microvascular and Cardiovascular Outcomes According to Renal Function in Patients Treated With Once-Weekly Exenatide: Insights From the EXSCEL Trial.,"OBJECTIVE
To evaluate the impact of once-weekly exenatide (EQW) on microvascular and cardiovascular (CV) outcomes by baseline renal function in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).
RESEARCH DESIGN AND METHODS
Least squares mean difference (LSMD) in estimated glomerular filtration rate (eGFR) from baseline between the EQW and placebo groups was calculated for 13,844 participants. Cox regression models were used to estimate effects by group on incident macroalbuminuria, retinopathy, and major adverse CV events (MACE). Interval-censored time-to-event models estimated effects on renal composite 1 (40% eGFR decline, renal replacement, or renal death) and renal composite 2 (composite 1 variables plus macroalbuminuria).
RESULTS
EQW did not change eGFR significantly (LSMD 0.21 mL/min/1.73 m 2 [95% CI -0.27 to 0.70]). Macroalbuminuria occurred in 2.2% of patients in the EQW group and in 2.5% of those in the placebo group (hazard ratio [HR] 0.87 [95% CI 0.70-1.07]). Neither renal composite was reduced with EQW in unadjusted analyses, but renal composite 2 was reduced after adjustment (HR 0.85 [95% CI 0.74-0.98]). Retinopathy rates did not differ by treatment group or in the HbA 1c -lowering or prior retinopathy subgroups. CV outcomes in those with eGFR <60 mL/min/1.73 m 2 did not differ by group. Those with eGFR ≥60 mL/min/1.73 m 2 had nominal risk reductions for MACE, all-cause mortality, and CV death, but interactions by renal function group were significant for only stroke (HR 0.74 [95% CI 0.58-0.93]; P for interaction = 0.035) and CV death (HR 1.08 [95% CI 0.85-1.38]; P for interaction = 0.031).
CONCLUSIONS
EQW had no impact on unadjusted retinopathy or renal outcomes. CV risk was modestly reduced only in those with eGFR ≥60 mL/min/1.73 m 2 in analyses unadjusted for multiplicity.",2020,CV risk was modestly reduced only in those with eGFR ≥60,"['groups was calculated for 13,844 participants']","['placebo', 'EQW', 'exenatide (EQW']","['renal composite 2', 'CV risk', 'unadjusted retinopathy or renal outcomes', 'Microvascular and Cardiovascular Outcomes', 'renal replacement, or renal death', 'renal composite', 'Retinopathy rates', 'CV outcomes', 'CV death', 'Macroalbuminuria', 'nominal risk reductions for MACE, all-cause mortality, and CV death', 'glomerular filtration rate (eGFR', 'microvascular and cardiovascular (CV) outcomes', 'incident macroalbuminuria, retinopathy, and major adverse CV events (MACE']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035309', 'cui_str': 'Retinal Diseases'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1654921', 'cui_str': 'Macroalbuminuria'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.309193,CV risk was modestly reduced only in those with eGFR ≥60,"[{'ForeName': 'M Angelyn', 'Initials': 'MA', 'LastName': 'Bethel', 'Affiliation': 'Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford, U.K.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Merrill', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Division of Endocrinology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Juliana C', 'Initials': 'JC', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, The Prince of Wales Hospital, Shatin, Hong Kong SAR, China.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""St. Michael's Hospital, University of Toronto, Ontario, Canada.""}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Neli', 'Initials': 'N', 'LastName': 'Jakuboniene', 'Affiliation': 'Department of Endocrinology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Lokhnygina', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Florence, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ohman', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Tsvetalina', 'Initials': 'T', 'LastName': 'Tankova', 'Affiliation': 'Clinical Center of Endocrinology, Medical University, Sofia, Bulgaria.'}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Bakris', 'Affiliation': 'Comprehensive Hypertension Center, The University of Chicago Medicine, Chicago, IL.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford, U.K. rury.holman@dtu.ox.ac.uk.'}]",Diabetes care,['10.2337/dc19-1065']
615,31757635,Acute consumption of Black walnuts increases fullness and decreases lipid peroxidation in humans.,"Walnuts are a nutrient dense food, but most health research is on English walnuts (EW). Black walnuts (BW) contain a different antioxidant and fatty acid profile, and more protein, compared to EW. The purpose of the study was to compare postprandial responses following the consumption of 3 breakfast meals containing either butter (control), BW, or EW. We hypothesized that walnut-containing meals would mitigate post-meal increases in glucose, insulin, triglycerides, and lipid peroxidation while increasing TAC compared to the traditional meal without nuts. Furthermore, we hypothesized that the BW meal would exhibit greater TAC and subjective fullness while mitigating postprandial increases in lipid peroxidation better than the EW. This was a randomized, double-blind control crossover study in 30 healthy adults with three testing visits. At each visit, subjects consumed either the control, BW, or EW meal. Blood draws and visual analog scale appetite ratings were obtained at fasting, 30, 60, 120, and 180 min postprandially. The BW and EW meals resulted in greater suppression of appetite vs. control (P < .01 and P = .03, respectively), and the BW meal also increased fullness more than EW and control (P < .01 and P < .001, respectively). Finally, the BW meal also had a greater suppression of lipid peroxidation vs. control (P = .01). There were no other treatment differences in the other measures of appetite or for glycemia, triglycerides, or total antioxidant capacity. Substituting butter in a breakfast meal with BW or EW increased fullness; however, the BW meal was superior for suppressing overall appetite while also lowering postprandial lipid peroxidation.",2019,"There were no other treatment differences in the other measures of appetite or for glycemia, triglycerides, or total antioxidant capacity.","['30 healthy adults with three testing visits', 'humans']","['3 breakfast meals containing either butter (control), BW, or EW']","['fullness', 'suppression of lipid peroxidation', 'glucose, insulin, triglycerides, and lipid peroxidation', 'appetite or for glycemia, triglycerides, or total antioxidant capacity', 'Blood draws and visual analog scale appetite ratings', 'postprandial lipid peroxidation', 'TAC and subjective fullness', 'lipid peroxidation', 'suppression of appetite vs. control (P', 'postprandial responses']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0006494', 'cui_str': 'Butter'}]","[{'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",30.0,0.0319571,"There were no other treatment differences in the other measures of appetite or for glycemia, triglycerides, or total antioxidant capacity.","[{'ForeName': 'Liana L', 'Initials': 'LL', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Foods and Nutrition, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Jamie A', 'Initials': 'JA', 'LastName': 'Cooper', 'Affiliation': 'Department of Foods and Nutrition, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Chad M', 'Initials': 'CM', 'LastName': 'Paton', 'Affiliation': 'Department of Foods and Nutrition, University of Georgia, Athens, GA, USA; Department of Food Science and Technology, University of Georgia, Athens, GA, USA. Electronic address: cpaton@uga.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2019.09.002']
616,26520160,Employing a Multi-level Approach to Recruit a Representative Sample of Women with Recent Gestational Diabetes Mellitus into a Randomized Lifestyle Intervention Trial.,"OBJECTIVE
The postpartum period is a window of opportunity for diabetes prevention in women with recent gestational diabetes (GDM), but recruitment for clinical trials during this period of life is a major challenge.
METHODS
We adapted a social-ecologic model to develop a multi-level recruitment strategy at the macro (high or institutional level), meso (mid or provider level), and micro (individual) levels. Our goal was to recruit 100 women with recent GDM into the Balance after Baby randomized controlled trial over a 17-month period. Participants were asked to attend three in-person study visits at 6 weeks, 6, and 12 months postpartum. They were randomized into a control arm or a web-based intervention arm at the end of the baseline visit at six weeks postpartum. At the end of the recruitment period, we compared population characteristics of our enrolled subjects to the entire population of women with GDM delivering at Brigham and Women's Hospital (BWH).
RESULTS
We successfully recruited 107 of 156 (69 %) women assessed for eligibility, with the majority (92) recruited during pregnancy at a mean 30 (SD ± 5) weeks of gestation, and 15 recruited postpartum, at a mean 2 (SD ± 3) weeks postpartum. 78 subjects attended the initial baseline visit, and 75 subjects were randomized into the trial at a mean 7 (SD ± 2) weeks postpartum. The recruited subjects were similar in age and race/ethnicity to the total population of 538 GDM deliveries at BWH over the 17-month recruitment period.
CONCLUSIONS
Our multilevel approach allowed us to successfully meet our recruitment goal and recruit a representative sample of women with recent GDM. We believe that our most successful strategies included using a dedicated in-person recruiter, integrating recruitment into clinical flow, allowing for flexibility in recruitment, minimizing barriers to participation, and using an opt-out strategy with providers. Although the majority of women were recruited while pregnant, women recruited in the early postpartum period were more likely to present for the first study visit. Given the increased challenges of recruiting postpartum women with GDM into research studies, we believe our findings will be useful to other investigators seeking to study this population.",2016,"The recruited subjects were similar in age and race/ethnicity to the total population of 538 GDM deliveries at BWH over the 17-month recruitment period.
","['78 subjects attended the initial baseline visit, and 75 subjects', 'recruited subjects were similar in age and race/ethnicity to the total population of 538 GDM deliveries at BWH over the 17-month recruitment period', 'We successfully recruited 107 of 156 (69 %) women assessed for eligibility, with the majority (92) recruited during pregnancy at a mean 30 (SD ± 5) weeks of gestation, and 15 recruited postpartum, at a mean 2 (SD ± 3) weeks postpartum', ""enrolled subjects to the entire population of women with GDM delivering at Brigham and Women's Hospital (BWH"", '100 women with recent GDM into the Balance after Baby randomized controlled trial over a 17-month period', 'women with recent gestational diabetes (GDM', 'Women with Recent Gestational Diabetes Mellitus']",[],[],"[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0050288', 'cui_str': 'A 17'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}]",[],[],100.0,0.2457,"The recruited subjects were similar in age and race/ethnicity to the total population of 538 GDM deliveries at BWH over the 17-month recruitment period.
","[{'ForeName': 'Jacinda M', 'Initials': 'JM', 'LastName': 'Nicklas', 'Affiliation': 'Division of General Internal Medicine, University of Colorado School of Medicine, Anschutz Health and Wellness Center, Mailstop C263, 12348 E. Montview Blvd., Aurora, CO, 80045, USA. Jacinda.Nicklas@ucdenver.edu.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Skurnik', 'Affiliation': ""Division of Diabetes, Hypertension and Endocrinology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Chloe A', 'Initials': 'CA', 'LastName': 'Zera', 'Affiliation': ""Division of Maternal-Fetal Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Liberty G', 'Initials': 'LG', 'LastName': 'Reforma', 'Affiliation': ""Division of Diabetes, Hypertension and Endocrinology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Sue E', 'Initials': 'SE', 'LastName': 'Levkoff', 'Affiliation': 'College of Social Work, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Ellen W', 'Initials': 'EW', 'LastName': 'Seely', 'Affiliation': ""Division of Diabetes, Hypertension and Endocrinology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",Maternal and child health journal,['10.1007/s10995-015-1825-8']
617,32410578,Application of the matched nested case-control design to the secondary analysis of trial data.,"BACKGROUND
A nested case-control study is an efficient design that can be embedded within an existing cohort study or randomised trial. It has a number of advantages compared to the conventional case-control design, and has the potential to answer important research questions using untapped prospectively collected data.
METHODS
We demonstrate the utility of the matched nested case-control design by applying it to a secondary analysis of the Abnormal Doppler Enteral Prescription Trial. We investigated the role of milk feed type and changes in milk feed type in the development of necrotising enterocolitis in a group of 398 high risk growth-restricted preterm infants.
RESULTS
Using matching, we were able to generate a comparable sample of controls selected from the same population as the cases. In contrast to the standard case-control design, exposure status was ascertained prior to the outcome event occurring and the comparison between the cases and matched controls could be made at the point at which the event occurred. This enabled us to reliably investigate the temporal relationship between feed type and necrotising enterocolitis.
CONCLUSIONS
A matched nested case-control study can be used to identify credible associations in a secondary analysis of clinical trial data where the exposure of interest was not randomised, and has several advantages over a standard case-control design. This method offers the potential to make reliable inferences in scenarios where it would be unethical or impractical to perform a randomised clinical trial.",2020,"It has a number of advantages compared to the conventional case-control design, and has the potential to answer important research questions using untapped prospectively collected data.
",['necrotising enterocolitis in a group of 398 high risk growth-restricted preterm infants'],[],[],"[{'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]",[],[],,0.039978,"It has a number of advantages compared to the conventional case-control design, and has the potential to answer important research questions using untapped prospectively collected data.
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Partlett', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK. chris.partlett@nottingham.ac.uk.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Hall', 'Affiliation': 'University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Leaf', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}]",BMC medical research methodology,['10.1186/s12874-020-01007-w']
618,31154809,Levetiracetam for prophylactic treatment of pediatric migraine: A randomized double-blind placebo-controlled trial.,"INTRODUCTION
Few drugs are available for migraine prophylaxis in children. Levetiracetam is a broad-spectrum anti-seizure drug that has been suggested to be effective in reducing adult migraine episodes. We assessed the safety and efficacy of levetiracetam in the prevention of pediatric migraine.
METHODS
A randomized double-blind placebo-controlled trial was performed. Eligible participants were aged 4-17 years old with at least four migrainous episodes monthly or had severe disabling or intolerable episodes. Primary endpoints were the mean changes in monthly frequency and intensity of headaches from the baseline phase to the last month of the double-blind phase. Safety endpoint was the adverse effects reported.
RESULTS
Sixty-one participants (31 taking levetiracetam and 30 taking placebo) completed the study. All had a significant reduction in frequency and intensity of episodes that was significantly greater in the levetiracetam arm. Sixty eight percent of individuals in the treatment group reported more than 50% reduction of episodes at the end of the trial compared with 30% in the placebo group ( p -value: 0.007). Irritability, day-time sedation, and mild tic were reported.
CONCLUSION
Levetiracetam may be useful in migraine prevention and may decrease migraine episodes and severity.
TRIAL REGISTRATION
The study is prospectively registered with Iranian Registry of Clinical Trials; IRCT.ir, number IRCT2017021632603N1.",2019,Sixty eight percent of individuals in the treatment group reported more than 50% reduction of episodes at the end of the trial compared with 30% in the placebo group ( p-value: 0.007).,"['pediatric migraine', 'Eligible participants were aged 4-17 years old with at least four migrainous episodes monthly or had severe disabling or intolerable episodes', 'Sixty-one participants (31 taking levetiracetam and 30 taking', 'children']","['levetiracetam', 'Levetiracetam', 'placebo']","['Irritability, day-time sedation, and mild tic', 'safety and efficacy', 'reduction of episodes', 'frequency and intensity of episodes', 'mean changes in monthly frequency and intensity of headaches']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",,0.689101,Sixty eight percent of individuals in the treatment group reported more than 50% reduction of episodes at the end of the trial compared with 30% in the placebo group ( p-value: 0.007).,"[{'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Montazerlotfelahi', 'Affiliation': 'Pediatrics Center of Excellence, Department of Pediatric Neurology, Imam Ali Hospital, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Amanat', 'Affiliation': ""Faculty of Medicine, Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Tavasoli', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Agah', 'Affiliation': ""Faculty of Medicine, Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Zamani', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Josemir W', 'Initials': 'JW', 'LastName': 'Sander', 'Affiliation': 'Stichting Epilepsie Instellingen Nederland (SEIN), Heemstede, the Netherlands.'}, {'ForeName': 'Reza Shervin', 'Initials': 'RS', 'LastName': 'Badv', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mahdieh', 'Initials': 'M', 'LastName': 'Dehghani', 'Affiliation': 'Department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Heidari', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Seyed Ahmad', 'Initials': 'SA', 'LastName': 'Hosseini', 'Affiliation': 'Department of Pediatric Neurology, Golestan University of Medical Sciences, Golestan, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': ""Faculty of Medicine, Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mahmoud Reza', 'Initials': 'MR', 'LastName': 'Ashrafi', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}]",Cephalalgia : an international journal of headache,['10.1177/0333102419851814']
619,31134665,Self-Completion of the Patient-Generated Subjective Global Assessment Short Form Is Feasible and Is Associated With Increased Awareness on Malnutrition Risk in Patients With Head and Neck Cancer.,"BACKGROUND
We aimed to assess feasibility of self-completion of the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF) by head and neck cancer patients, and to assess self-reported increased awareness regarding malnutrition risk after self-completion.
METHODS
Participants were randomized to complete the PG-SGA SF by paper or app. Feasibility was assessed by time needed to complete the PG-SGA SF, perceived difficulty, and help needed during completion. Participants were asked if they knew what malnutrition was (yes/no) and if they could define ""malnutrition."" They were also asked 9 questions on whether they perceived increased awareness of malnutrition risk after having completed the PG-SGA SF and 2 on their intention to change lifestyle habits.
RESULTS
Of all participants (n = 59; 65.9 ± 12.6 years; 73% male), 55% completed the PG-SGA SF paper version and 46% the Pt-Global app. Median time needed for self-completion of the PG-SGA SF was 2 minutes 41 seconds (interquartile range: 1 minute 49 seconds-3 minutes 50 seconds). Forty-eight percent needed help with completion, indicating acceptable feasibility. Participants who completed the Pt-Global app needed help significantly more often (66%; 21/32) than those who completed the PG-SGA SF paper version (26%; 7/27) (P = 0.005). All difficulty scores were excellent. For 7/9 questions on malnutrition risk awareness, >50% of the participants answered positively.
CONCLUSION
The results of this study show that self-completion of the PG-SGA SF by head and neck cancer patients is feasible and that awareness regarding malnutrition risk may increase after completing the PG-SGA SF.",2020,Participants who completed the Pt-Global app needed help significantly more often (66%; 21/32) than those who completed the PG-SGA SF paper version (26%; 7/27) (P = 0.005).,"['head and neck cancer patients', 'Patients With Head and Neck Cancer', 'Of all participants (n\xa0= 59; 65.9 ± 12.6 years; 73% male', 'Participants']","['PG-SGA SF by paper or app', 'Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF']","['Median time needed for self-completion', 'malnutrition risk awareness', 'awareness of malnutrition risk']","[{'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517545', 'cui_str': 'Twelve point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",,0.0713384,Participants who completed the Pt-Global app needed help significantly more often (66%; 21/32) than those who completed the PG-SGA SF paper version (26%; 7/27) (P = 0.005).,"[{'ForeName': 'Harriët', 'Initials': 'H', 'LastName': 'Jager-Wittenaar', 'Affiliation': 'Department of Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'de Bats', 'Affiliation': 'Department of Dietetics, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Bertine J', 'Initials': 'BJ', 'LastName': 'Welink-Lamberts', 'Affiliation': 'Department of Dietetics, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Dorienke', 'Initials': 'D', 'LastName': 'Gort-van Dijk', 'Affiliation': 'Department of Dietetics, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Bernard F A M', 'Initials': 'BFAM', 'LastName': 'van der Laan', 'Affiliation': 'Department of Otorhinolaryngology/Head & Neck Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Faith D', 'Initials': 'FD', 'LastName': 'Ottery', 'Affiliation': 'Research Group Healthy Ageing, Allied Health Care and Nursing, Hanze University of Applied Sciences, Groningen, the Netherlands.'}, {'ForeName': 'Jan L N', 'Initials': 'JLN', 'LastName': 'Roodenburg', 'Affiliation': 'Department of Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}]",Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition,['10.1002/ncp.10313']
620,31424395,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PF-06751979, a Potent and Selective Oral BACE1 Inhibitor: Results from Phase I Studies in Healthy Adults and Healthy Older Subjects.","PF-06751979 is a selective inhibitor of the beta-site amyloid precursor protein cleaving enzyme-1, which is a key aspartyl protease in the generation of amyloid-β (Aβ) peptides, thought to be critical for the cerebral degeneration observed in Alzheimer's disease. Two Phase I studies (NCT02509117, NCT02793232) investigated the safety/tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-06751979. Single-ascending doses up to 540 mg and multiple-ascending doses up to 275 mg once daily (QD) in healthy adults, and multiple doses of 50 mg or 125 mg QD in healthy older subjects were assessed. PF-06751979 was well tolerated at all doses given, and all treatment-related adverse events (AEs) were mild to moderate. PK parameters remained consistent across the PF-06751979 QD dosing regimens, and no notable food effects were observed. PD analysis showed that PF-06751979 reduced the cerebrospinal fluid (CSF) and plasma levels of Aβ peptides in a dose-dependent manner, with the greatest reductions observed in subjects treated with 275 mg QD (approximately 92% and 93% reduction in CSF Aβ1-40 and Aβ1-42 observed at 24 h after Day 14 dose, respectively). A drug interaction study (NCT03126721) using midazolam indicated that there was no clinically meaningful effect of multiple doses of PF-06751979 100 mg QD on the PK of single-dose midazolam in healthy adults. Overall, these data suggest that PF-06751979 with daily dosing is favorable for further clinical development.",2019,"PF-06751979 is a selective inhibitor of the beta-site amyloid precursor protein cleaving enzyme-1, which is a key aspartyl protease in the generation of amyloid-β (Aβ) peptides, thought to be critical for the cerebral degeneration observed in Alzheimer's disease.","['Healthy Adults and Healthy Older Subjects', 'healthy older subjects', 'healthy adults']",['midazolam'],"['safety/tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-06751979', 'PK parameters', 'cerebrospinal fluid (CSF) and plasma levels of Aβ peptides', 'tolerated', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PF-06751979, a Potent and Selective Oral']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0007807'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",42.0,0.0293733,"PF-06751979 is a selective inhibitor of the beta-site amyloid precursor protein cleaving enzyme-1, which is a key aspartyl protease in the generation of amyloid-β (Aβ) peptides, thought to be critical for the cerebral degeneration observed in Alzheimer's disease.","[{'ForeName': 'Ruolun', 'Initials': 'R', 'LastName': 'Qiu', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Jae Eun', 'Initials': 'JE', 'LastName': 'Ahn', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Alexander', 'Affiliation': 'Takeda Pharmaceuticals International Co, Cambridge, MA, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Brodney', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'Biogen Inc, Cambridge, MA, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Leurent', 'Affiliation': 'Samsung Ventures, Boston, MA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Margolin', 'Affiliation': 'Clinical Research Solutions LLC, Cambridge, MA, USA.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Tankisheva', 'Affiliation': 'Pfizer Clinical Research Unit Brussels, Belgium.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190228']
621,31751994,The Effect of Individualized Developmental Care Practices in Preterm Infants.,"BACKGROUND
Preterm infants are vulnerable humans requiring much care and attention. They may be exposed to irregular noise, light, and odor in the neonatal intensive care unit for a period of several weeks or months. This study was carried out to determine the effect of individualized developmental care on physiological parameters, growth, and transition to oral feeding in preterm infants.
METHODS
The study was a randomized controlled trial. The sample comprised premature infants meeting the inclusion criteria. They were randomly assigned to four groups: the maternal voice group, the breast milk odor (BMO) group, the incubator cover (IC) group, and the control group.
RESULTS
No statistically significant difference was found between the groups in terms of weight, height, and head circumference at time of discharge. Mean SO2 values were statistically higher in the IC group than the other groups; however, the heart rate and respiratory rate were not statistically different in a significant sense between the groups. The briefest duration of transition to total oral feeding was seen in the BMO group.
CONCLUSION
Individualized developmental care practices based on the results of these interventions are likely to support the care of preterm infants. Breast milk odor may ease the transition to breastfeeding.",2020,"No statistically significant difference was found between the groups in terms of weight, height, and head circumference at time of discharge.","['preterm infants', 'Preterm Infants']","['Individualized Developmental Care Practices', 'maternal voice group, the breast milk odor (BMO) group, the incubator cover (IC) group, and the control group', 'individualized developmental care']","['weight, height, and head circumference at time of discharge', 'briefest duration of transition to total oral feeding', 'heart rate and respiratory rate', 'Mean SO2 values', 'physiological parameters, growth, and transition to oral feeding']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0204796', 'cui_str': 'Special care of premature baby (regime/therapy)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0028884', 'cui_str': 'Odors'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.0404892,"No statistically significant difference was found between the groups in terms of weight, height, and head circumference at time of discharge.","[{'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Küçük Alemdar', 'Affiliation': 'Giresun University, Health Sciences Faculty, Department of Nursing, Giresun, Turkey, dilekkucuk@atauni.edu.tr.'}, {'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'İnal', 'Affiliation': 'Istanbul University, Health Sciences Faculty, Department of Midwifery, Istanbul, Turkey.'}]",Complementary medicine research,['10.1159/000504357']
622,31743987,"Comparison of ultrasound-guided platelet-rich plasma, prolotherapy, and corticosteroid injections in rotator cuff lesions.","BACKGROUND
Injections are a good alternative to conventional treatment-resistant cases with rotator cuff (RC) lesions before operation. Currently, different injection methods are used in RC lesions.
OBJECTIVE
To evaluate the efficacy of different injection methods (platelet-rich plasma [PRP], corticosteroid [COR] and prolotherapy [PRO]) in RC tendon lesions.
METHODS
One hundred and twenty-nine patients were divided into 4 groups as PRP, COR, PRO and the lidocaine group. Subacromial injection was applied to all groups. They were evaluated using the Visual Analogue Scale (VAS), American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), and Western Ontario Rotator Cuff Index (WORC) at 3, 12 and 24 weeks post-injection.
RESULTS
In the COR group in the 3rd week, VAS and WORC scores were significantly lower than the other groups (p< 0.01 and p< 0.05 respectively). In the PRP group in the 24th week, VAS and WORC scores were found to be significantly lower than the COR group (p< 0.01 and p< 0.05 respectively). In the COR group in the 3rd week the ASES score was found to be significantly higher than the PRP and PRO group (p< 0.01).
CONCLUSION
In patients with RC lesions, corticosteroid injection provides short-term relief for pain, function, and quality of life, while PRP injection works for long-term wellbeing. For all types of applied injections, improvement in pain, function and quality of life were observed.",2020,"In the COR group in the 3rd week the ASES score was found to be significantly higher than the PRP and PRO group (p< 0.01).
","['rotator cuff lesions', 'patients with RC lesions', 'One hundred and twenty-nine patients']","['corticosteroid injection', 'lidocaine', 'ultrasound-guided platelet rich plasma, prolotherapy, and corticosteroid injections', 'Subacromial injection', 'injection methods (platelet-rich plasma [PRP], corticosteroid [COR] and prolotherapy [PRO']","['Visual Analogue Scale (VAS), American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), and Western Ontario Rotator Cuff Index (WORC', 'pain, function, and quality of life', 'pain, function and quality of life', 'ASES score', 'VAS and WORC scores']","[{'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0500223', 'cui_str': 'Proliferation Therapy'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",129.0,0.0147443,"In the COR group in the 3rd week the ASES score was found to be significantly higher than the PRP and PRO group (p< 0.01).
","[{'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Sari', 'Affiliation': 'Erenkoy Physical Therapy and Rehabilitation Hospital, Physical Medicine and Rehabilitation Clinic, Istanbul, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Eroglu', 'Affiliation': 'Erenkoy Physical Therapy and Rehabilitation Hospital, Sports Medicine Clinic, Istanbul, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-191519']
623,31753895,"Efficacy of Bifidobacterium longum, B. infantis and Lactobacillus acidophilus probiotics to prevent gut dysbiosis in preterm infants of 28+0-32+6 weeks of gestation: a randomised, placebo-controlled, double-blind, multicentre trial: the PRIMAL Clinical Study protocol.","INTRODUCTION
The healthy 'eubiosis' microbiome in infancy is regarded as the microbiome derived from term, vaginally delivered, antibiotic free, breastfed infants at 4-6 months. Dysbiosis is regarded as a deviation from a healthy state with reduced microbial diversity and deficient capacity to control drug-resistant organisms. Preterm infants are highly sensitive to early gut dysbiosis. Latter has been associated with sepsis and necrotising enterocolitis, but may also contribute to long-term health problems. Probiotics hold promise to reduce the risk for adverse short-term outcomes but the evidence from clinical trials remains inconclusive and none has directly assessed the effects of probiotics on the microbiome at high resolution.
METHODS AND ANALYSIS
A randomised, double blind, placebo-controlled study has been designed to assess the safety and efficacy of the probiotic mix of Bifidobacterium longum and infantis and Lactobacillus acidophilus in the prevention of gut dysbiosis in preterm infants between 28+0 and 32+6 weeks of gestation. The study is conducted in 18 German neonatal intensive care units. Between April 2018 and March 2020, 654 preterm infants of 28+0-32+6 weeks of gestation will be randomised in the first 48 hours of life to 28 days of once daily treatment with either probiotics or placebo. The efficacy endpoint is the prevention of gut dysbiosis at day 30 of life. A compound definition of gut dysbosis is used: (1) colonisation with multidrug-resistant organisms or gram-negative bacteria with high epidemic potential or (2) a significant deviation of the gut microbiota composition as compared with healthy term infants. Dysbiosis is determined by (1) conventional microbiological culture and (2) phylogenetic microbiome analysis by high-throughput 16S rRNA and metagenome sequencing. Persistence of dysbiosis will be assessed at 12-month follow-up visits. Side effects and adverse events related to the intervention will be recorded. Key secondary endpoint(s) are putative consequences of dysbiosis. A subgroup of infants will be thoroughly phenotyped for immune parameters using chipcytometry.
ETHICS AND DISSEMINATION
Ethics approval was obtained in all participating sites. Results of the trial will be published in peer-review journals, at scientific meetings, on the website (www.primal-study.de) and via social media of parent organisations.
TRIAL REGISTRATION NUMBER
DRKS00013197; Pre-results.",2019,"Probiotics hold promise to reduce the risk for adverse short-term outcomes but the evidence from clinical trials remains inconclusive and none has directly assessed the effects of probiotics on the microbiome at high resolution.
","['Preterm infants', 'preterm infants between 28+0\u2009and 32+6 weeks of gestation', 'preterm infants of 28+0-32+6 weeks of gestation', 'Between April 2018 and March 2020, 654 preterm infants of 28+0-32+6 weeks of gestation', '18 German neonatal intensive care units', 'healthy term infants']","['placebo', 'Bifidobacterium longum, B. infantis and Lactobacillus acidophilus probiotics', 'probiotics or placebo']","['safety and efficacy', 'Side effects and adverse events']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",654.0,0.386743,"Probiotics hold promise to reduce the risk for adverse short-term outcomes but the evidence from clinical trials remains inconclusive and none has directly assessed the effects of probiotics on the microbiome at high resolution.
","[{'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Marißen', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haiß', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': 'Department of Paediatrics, University Medical Centre, Mainz, Germany.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Van Rossum', 'Affiliation': 'Structural and Computational Biology Unit, European Molecular Biology Laboratory, Heidelberg, Germany.'}, {'ForeName': 'Lisa Marie', 'Initials': 'LM', 'LastName': 'Bünte', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Frommhold', 'Affiliation': ""Children's Hospital Memmingen, Memmingen, Germany.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gille', 'Affiliation': 'Department of Neonatology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Sybelle', 'Initials': 'S', 'LastName': 'Goedicke-Fritz', 'Affiliation': 'Department of General Paediatrics and Neonatology, Saarland University, Homburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Göpel', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Hudalla', 'Affiliation': 'Department of Neonatology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Pagel', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Pirr', 'Affiliation': 'Department of Paediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Siller', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Dorothee', 'Initials': 'D', 'LastName': 'Viemann', 'Affiliation': 'Department of Paediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Vens', 'Affiliation': 'Institute of Medical Biometry and Statistics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Inke', 'Initials': 'I', 'LastName': 'König', 'Affiliation': 'Institute of Medical Biometry and Statistics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Egbert', 'Initials': 'E', 'LastName': 'Herting', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zemlin', 'Affiliation': 'Department of General Paediatrics and Neonatology, Saarland University, Homburg, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Gehring', 'Affiliation': 'Department of Paediatrics, University Medical Centre, Mainz, Germany.'}, {'ForeName': 'Peer', 'Initials': 'P', 'LastName': 'Bork', 'Affiliation': 'Structural and Computational Biology Unit, European Molecular Biology Laboratory, Heidelberg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Henneke', 'Affiliation': 'Insitute for Immunodeficiency (CCI) and Centre for Paediatrics and Adolescent Medicine, Medical Centre and Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Härtel', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany christoph.haertel@uksh.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-032617']
624,31678957,A randomised controlled trial of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia in psychiatric outpatient clinics: study protocol for the J-SUPPORT 1901 (ACCESS) study.,"INTRODUCTION
One of the reasons for the high mortality rate from cancer in people with schizophrenia is delay in diagnosis. Many studies have shown lower cancer screening rates in people with schizophrenia; however, there are no interventions for people with schizophrenia to increase cancer screening. Therefore, we developed a case management (CM) intervention to encourage participation in cancer screening. The purpose of this study was to examine the efficacy of CM to encourage participation in cancer screening for people with schizophrenia, with particular focus on colorectal cancer screening by faecal occult blood testing, compared with usual intervention (UI), namely, municipal public education.
METHODS AND ANALYSIS
This is an individually randomised, parallel group trial with blinded outcome assessments. The participants will be randomly allocated to either the CM plus UI group or UI alone group in a 1:1 ratio using a web-based program at a data management centre. The primary end point of the study is participation in colorectal cancer screening in the year of intervention, which will be assessed based on municipal records.
ETHICS AND DISSEMINATION
This study is performed in accordance with Ethical Guidelines for Medical and Health Research Involving Human Subjects published by Japan's Ministry of Education, Science, and Technology and the Ministry of Health, Labour, and Welfare and the modified Act on the Protection of Personal Information as well as the Declaration of Helsinki. This study was approved by the institutional ethics committee at the Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences and Okayama University Hospital on 23 April 2019 (approval number: RIN1904-003). The findings of this trial will be submitted to an international peer-reviewed journal.
TRIAL REGISTRATION NUMBER
UMIN000036017.",2019,"Many studies have shown lower cancer screening rates in people with schizophrenia; however, there are no interventions for people with schizophrenia to increase cancer screening.","['people with schizophrenia in psychiatric outpatient clinics', 'people with schizophrenia, with particular focus on colorectal cancer screening by faecal occult blood testing, compared with usual intervention (UI), namely, municipal public education', 'institutional ethics committee at the Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences and Okayama University Hospital on 23 April 2019 (approval number: RIN1904-003', 'people with schizophrenia']","['CM plus UI group or UI alone group in a 1:1 ratio using a web-based program at a data management centre', 'case management (CM) intervention', 'CM']",['colorectal cancer screening'],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces (procedure)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}]","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",,0.10723,"Many studies have shown lower cancer screening rates in people with schizophrenia; however, there are no interventions for people with schizophrenia to increase cancer screening.","[{'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Neuropsychiatry, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Inagaki', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Shimane University, Izumo, Japan minagaki@med.shimane-u.ac.jp.'}, {'ForeName': 'Taichi', 'Initials': 'T', 'LastName': 'Shimazu', 'Affiliation': 'Division of Prevention, Epidemiology and Prevention Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kodama', 'Affiliation': 'Okayama Psychiatric Medical Center, Okayama, Japan.'}, {'ForeName': 'Ryuhei', 'Initials': 'R', 'LastName': 'So', 'Affiliation': 'Okayama Psychiatric Medical Center, Okayama, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Matsushita', 'Affiliation': 'Zikei Hospital, Okayama, Japan.'}, {'ForeName': 'Yusaku', 'Initials': 'Y', 'LastName': 'Yoshimura', 'Affiliation': 'Zikei Hospital, Okayama, Japan.'}, {'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Horii', 'Affiliation': 'Zikei Hospital, Okayama, Japan.'}, {'ForeName': 'Maiko', 'Initials': 'M', 'LastName': 'Fujimori', 'Affiliation': 'Division of Health Care Research, Behavioral Sciences and Survivorship Research Group and Division of Cohort Consortium Research, Epidemiology and Prevention Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Division of Screening Assessment and Management, Epidemiology and Prevention Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Nakaya', 'Affiliation': 'Department of Health Sciences, Saitama Prefectural University, Koshigaya, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Kakeda', 'Affiliation': 'Department of Neuropsychiatry, Kochi Medical School, Kochi University, Nankoku, Japan.'}, {'ForeName': 'Tempei', 'Initials': 'T', 'LastName': 'Miyaji', 'Affiliation': 'Department of Clinical Trial Data Management, Tokyo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Hinotsu', 'Affiliation': 'Department of Biostatistics, Sapporo Medical University, Sapporo, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Department of Gastroenterology, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Uchitomi', 'Affiliation': 'Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital and Behavioral Sciences and Survivorship Research Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Yamada', 'Affiliation': 'Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-032955']
625,31532482,Challenges and opportunities using online portals to recruit diverse patients to behavioral trials.,"We describe the use of an online patient portal to recruit and enroll primary care patients in a randomized trial testing the effectiveness of a colorectal cancer (CRC) screening decision support program. We use multiple logistic regression to identify patient characteristics associated with trial recruitment, enrollment, and engagement. We found that compared to Whites, Blacks had lower odds of viewing the portal message (OR = 0.46, 95% CI = 0.37-0.57), opening the attached link containing the study material (OR = 0.75, 95% CI = 0.62-0.92), and consenting to participate in the trial (OR = 0.85, 95% CI = 0.67-0.93). We also found that compared to Whites, Asians had lower odds of viewing the portal message (OR = 0.53, 95% CI = 0.33-0.64), opening the attached link containing the study material (OR = 0.76, 95% CI = 0.54-0.97), consenting to participate in the trial (OR = 0.68, 95% CI = 0.53-0.95), and completing the trial's baseline questionnaire (OR = 0.59, 95% CI = 0.36-0.90). While portals offer an opportunity to mitigate human bias in trial invitations, because of racial disparities-not only in who has a portal account, but in how they interact with trial recruitment and enrollment material within the portal-using portals alone for trial recruitment may generate study samples that are not racially diverse.",2019,"We found that compared to Whites, Blacks had lower odds of viewing the portal message (OR = 0.46, 95% CI = 0.37-0.57), opening the attached link containing the study material (OR = 0.75, 95% CI = 0.62-0.92), and consenting to participate in the trial (OR = 0.85, 95% CI = 0.67-0.93).",[],['colorectal cancer (CRC) screening decision support program'],['viewing the portal message'],[],"[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}]",,0.136261,"We found that compared to Whites, Blacks had lower odds of viewing the portal message (OR = 0.46, 95% CI = 0.37-0.57), opening the attached link containing the study material (OR = 0.75, 95% CI = 0.62-0.92), and consenting to participate in the trial (OR = 0.85, 95% CI = 0.67-0.93).","[{'ForeName': 'Amir Alishahi', 'Initials': 'AA', 'LastName': 'Tabriz', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Patrice Jordan', 'Initials': 'PJ', 'LastName': 'Fleming', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Yongyun', 'Initials': 'Y', 'LastName': 'Shin', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior & Health Education, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Resa M', 'Initials': 'RM', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health and Fox Chase Cancer Center, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Flocke', 'Affiliation': 'Department of Family Medicine, Oregon Health Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'Deirdre A', 'Initials': 'DA', 'LastName': 'Shires', 'Affiliation': 'School of Social Work, Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Hawley', 'Affiliation': 'Department of Medicine, Center for Health Communications Research, University of Michigan and Ann Arbor VA Center for Clinical Management Research, Ann Arbor, Michigan, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Willens', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan, USA.'}, {'ForeName': 'Jennifer Elston', 'Initials': 'JE', 'LastName': 'Lafata', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz157']
626,31087175,A mobile device application (app) to improve adherence to an enhanced recovery program for colorectal surgery: a randomized controlled trial.,"BACKGROUND
Increased adherence with enhanced recovery pathways (ERP) is associated with improved outcomes. However, adherence to postoperative elements that rely on patient participation remains suboptimal. Mobile device apps may improve delivery of health education material and have the potential to foster behavior change and improve patient compliance. The objective of this study was to estimate the extent to which a novel mobile device app affects adherence to an ERP for colorectal surgery in comparison to standard written education.
METHODS
This was a superiority, parallel-group, assessor-blind, sham-controlled randomized trial involving 97 patients undergoing colorectal resection. Participants were randomly assigned with a 1:1 ratio into one of two groups: (1) iPad including a novel mobile device app for postoperative education and self-assessment of recovery, or (2) iPad without the app. The primary outcome measure was mean adherence (%) to a bundle of five postoperative ERP elements requiring patient participation: mobilization, gastrointestinal motility stimulation, breathing exercises, and consumption of oral liquids and nutritional drinks.
RESULTS
In the intervention group, app usage was high (94% completed surveys on POD0, 82% on POD1, 72% on POD2). Mean overall adherence to the bundle on the two first postoperative days was similar between groups: 59% (95% CI 52-66%) in the intervention group and 62% (95% CI 56-68%) in the control group [Adjusted mean difference 2.4% (95% CI - 5 to 10%) p = 0.53].
CONCLUSIONS
In this randomized trial, access to a mobile health application did not improve adherence to a well-established enhanced recovery pathway in colorectal surgery patients, when compared to standard written patient education. Future research should evaluate the impact of applications integrating novel behavioral change techniques, particularly in contexts where adherence is low.",2020,"In the intervention group, app usage was high (94% completed surveys on POD0, 82% on POD1, 72% on POD2).","['colorectal surgery', '97 patients undergoing colorectal resection', 'colorectal surgery patients']","['iPad including a novel mobile device app for postoperative education and self-assessment of recovery, or (2) iPad without the app', 'mobile device application (app']","['Mean overall adherence', 'mean adherence (%) to a bundle of five postoperative ERP elements requiring patient participation: mobilization, gastrointestinal motility stimulation, breathing exercises, and consumption of oral liquids and nutritional drinks']","[{'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0337380', 'cui_str': 'Endoscopic retrograde pancreatography (procedure)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0030699', 'cui_str': 'Patient Involvement'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0017184', 'cui_str': 'Gastrointestinal Motility'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0006155', 'cui_str': 'Respiratory Muscle Training'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1273619', 'cui_str': 'Oral Liquid Product'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]",97.0,0.203639,"In the intervention group, app usage was high (94% completed surveys on POD0, 82% on POD1, 72% on POD2).","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Mata', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University Health Centre, 1650 Cedar Ave, L9.309, Montreal, QC, H3G 1A4, Canada.'}, {'ForeName': 'Nicolò', 'Initials': 'N', 'LastName': 'Pecorelli', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University Health Centre, 1650 Cedar Ave, L9.309, Montreal, QC, H3G 1A4, Canada.'}, {'ForeName': 'Pepa', 'Initials': 'P', 'LastName': 'Kaneva', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University Health Centre, 1650 Cedar Ave, L9.309, Montreal, QC, H3G 1A4, Canada.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Moldoveanu', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gosselin-Tardiff', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Alhashemi', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University Health Centre, 1650 Cedar Ave, L9.309, Montreal, QC, H3G 1A4, Canada.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Robitaille', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University Health Centre, 1650 Cedar Ave, L9.309, Montreal, QC, H3G 1A4, Canada.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Balvardi', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University Health Centre, 1650 Cedar Ave, L9.309, Montreal, QC, H3G 1A4, Canada.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University Health Centre, 1650 Cedar Ave, L9.309, Montreal, QC, H3G 1A4, Canada.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Stein', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Liberman', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Charlebois', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Julio F', 'Initials': 'JF', 'LastName': 'Fiore', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University Health Centre, 1650 Cedar Ave, L9.309, Montreal, QC, H3G 1A4, Canada.'}, {'ForeName': 'Liane S', 'Initials': 'LS', 'LastName': 'Feldman', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University Health Centre, 1650 Cedar Ave, L9.309, Montreal, QC, H3G 1A4, Canada. liane.feldman@mcgill.ca.'}]",Surgical endoscopy,['10.1007/s00464-019-06823-w']
627,31712735,Early symptoms and sensations as predictors of lung cancer: a machine learning multivariate model.,"The aim of this study was to identify a combination of early predictive symptoms/sensations attributable to primary lung cancer (LC). An interactive e-questionnaire comprised of pre-diagnostic descriptors of first symptoms/sensations was administered to patients referred for suspected LC. Respondents were included in the present analysis only if they later received a primary LC diagnosis or had no cancer; and inclusion of each descriptor required ≥4 observations. Fully-completed data from 506/670 individuals later diagnosed with primary LC (n = 311) or no cancer (n = 195) were modelled with orthogonal projections to latent structures (OPLS). After analysing 145/285 descriptors, meeting inclusion criteria, through randomised seven-fold cross-validation (six-fold training set: n = 433; test set: n = 73), 63 provided best LC prediction. The most-significant LC-positive descriptors included a cough that varied over the day, back pain/aches/discomfort, early satiety, appetite loss, and having less strength. Upon combining the descriptors with the background variables current smoking, a cold/flu or pneumonia within the past two years, female sex, older age, a history of COPD (positive LC-association); antibiotics within the past two years, and a history of pneumonia (negative LC-association); the resulting 70-variable model had accurate cross-validated test set performance: area under the ROC curve = 0.767 (descriptors only: 0.736/background predictors only: 0.652), sensitivity = 84.8% (73.9/76.1%, respectively), specificity = 55.6% (66.7/51.9%, respectively). In conclusion, accurate prediction of LC was found through 63 early symptoms/sensations and seven background factors. Further research and precision in this model may lead to a tool for referral and LC diagnostic decision-making.",2019,An interactive e-questionnaire comprised of pre-diagnostic descriptors of first symptoms/sensations was administered to patients referred for suspected LC.,"['Respondents were included in the present analysis only\xa0if they later received a primary LC diagnosis or had no cancer; and inclusion of each descriptor required ≥4 observations', 'primary lung cancer (LC', '506/670 individuals later diagnosed with primary LC (n\u2009=\u2009311) or no cancer (n\u2009=\u2009195']",[],"['cough that varied over the day, back pain/aches/discomfort, early satiety, appetite loss, and having less strength']","[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4517624', 'cui_str': '195'}]",[],"[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0234238', 'cui_str': 'Ache'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0239233', 'cui_str': 'Early satiety (fullness)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}]",63.0,0.067058,An interactive e-questionnaire comprised of pre-diagnostic descriptors of first symptoms/sensations was administered to patients referred for suspected LC.,"[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Levitsky', 'Affiliation': 'Division of Innovative Care Research, Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institutet, SE-171 77, Solna, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pernemalm', 'Affiliation': 'Cancer Proteomics Mass Spectrometry, Department of Oncology-Pathology, Karolinska Institutet, Science for Life Laboratory, SE-171 65, Solna, Sweden.'}, {'ForeName': 'Britt-Marie', 'Initials': 'BM', 'LastName': 'Bernhardson', 'Affiliation': 'Division of Innovative Care Research, Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institutet, SE-171 77, Solna, Sweden.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Forshed', 'Affiliation': 'Cancer Proteomics Mass Spectrometry, Department of Oncology-Pathology, Karolinska Institutet, Science for Life Laboratory, SE-171 65, Solna, Sweden.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Kölbeck', 'Affiliation': 'Lung Oncology Center, Cancer Theme, Karolinska University Hospital, SE-171 76, Solna, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Olin', 'Affiliation': 'Lung Oncology Center, Cancer Theme, Karolinska University Hospital, SE-171 76, Solna, Sweden.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Henriksson', 'Affiliation': 'Department of Radiation Sciences and Oncology, University of Umeå, SE-901 87, Umeå, Sweden.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Lehtiö', 'Affiliation': 'Cancer Proteomics Mass Spectrometry, Department of Oncology-Pathology, Karolinska Institutet, Science for Life Laboratory, SE-171 65, Solna, Sweden.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Tishelman', 'Affiliation': 'Division of Innovative Care Research, Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institutet, SE-171 77, Solna, Sweden.'}, {'ForeName': 'Lars E', 'Initials': 'LE', 'LastName': 'Eriksson', 'Affiliation': 'Division of Innovative Care Research, Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institutet, SE-171 77, Solna, Sweden. lars.eriksson@ki.se.'}]",Scientific reports,['10.1038/s41598-019-52915-x']
628,31753903,Rationale and design of the Lowlands Saves Lives trial: a randomised trial to compare CPR quality and long-term attitude towards CPR performance between face-to-face and virtual reality training with the Lifesaver VR app.,"INTRODUCTION
Layperson cardiopulmonary resuscitation (CPR) is a key aspect in the chain of survival after cardiac arrest. New, low-cost, easily accessible training methods such as virtual reality (VR) training with a smartphone application may reach broader populations, but data on CPR performance are scarce.
METHODS AND ANALYSIS
The Lowlands Saves Lives trial is a prospective randomised open-blinded end-point evaluation study, comparing two 20 min CPR training protocols: standardised, certified instructor-led face-to-face training complying with current education guidelines (using Laerdal Little Anne manikins), and VR training, using the UK Resuscitation Council endorsed Lifesaver VR app. In the latter, chest compressions are practiced on a pillow.During VR training, participants learn to resuscitate by completing a filmed CPR scenario while wearing VR goggles and headphones. Eligible for inclusion are adult attendees of Lowlands Science, a specific section of the 3-day Lowlands music festival (50 000 attendees), dedicated exclusively to science. Following the training, all participants will perform a CPR test on a Laerdal Resusci Anne QCPR manikin. Primary outcome measures are depth and rate of chest compressions, measured using CPR manikins. The key secondary outcome is overall CPR performance, with real-time examination (blinded for study group) of all items of a European Resuscitation Council endorsed checklist, and evaluation of a sample of videotaped CPR tests by a blinded event committee.Given the unique setting of a festival, the primary additional analysis will address the impact of alcohol levels on CPR quality parameters and overall performance. Follow-up questionnaires will evaluate the attitude towards performing CPR. This unique study may provide important insights into innovative CPR training methods, factors that impact CPR performance and the impact on long-term attitude towards resuscitation.
ETHICS AND DISSEMINATION
This study received approval from the research ethics committee of the Radboudumc. All participants will provide written informed consent. The results of this study will be published in peer-reviewed journals and presented at (inter)national conferences.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov registry (NCT04013633).",2019,"New, low-cost, easily accessible training methods such as virtual reality (VR) training with a smartphone application may reach broader populations, but data on CPR performance are scarce.
","['Eligible for inclusion are adult attendees of Lowlands Science, a specific section of the 3-day Lowlands music festival (50 000 attendees), dedicated exclusively to science']","['Layperson cardiopulmonary resuscitation (CPR', 'certified instructor-led face-to-face training complying with current education guidelines (using Laerdal Little Anne manikins), and VR training']","['depth and rate of chest compressions, measured using CPR manikins', 'CPR quality parameters and overall performance', 'overall CPR performance, with real-time examination (blinded for study group) of all items of a European Resuscitation Council endorsed checklist, and evaluation of a sample of videotaped CPR tests']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0015922', 'cui_str': 'Festivals'}]","[{'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0556993', 'cui_str': 'Instructor (occupation)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0700321', 'cui_str': 'Small (qualifier value)'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.119092,"New, low-cost, easily accessible training methods such as virtual reality (VR) training with a smartphone application may reach broader populations, but data on CPR performance are scarce.
","[{'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Nas', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands j.nas@radboudumc.nl.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Thannhauser', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vart', 'Affiliation': 'Health Evidence, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'van Geuns', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Judith L', 'Initials': 'JL', 'LastName': 'Bonnes', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Brouwer', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-033648']
629,31554937,Long-term phase 3 study of esaxerenone as mono or combination therapy with other antihypertensive drugs in patients with essential hypertension.,"This study investigated the long-term antihypertensive effects of esaxerenone, a novel nonsteroidal mineralocorticoid receptor blocker, alone or in combination with a calcium channel blocker (CCB) or a renin-angiotensin system (RAS) inhibitor, in Japanese patients with essential hypertension. Patients were treated with esaxerenone starting at 2.5 mg/day increasing to 5 mg/day if required to achieve blood pressure (BP) targets as a monotherapy or with a CCB or RAS inhibitor. After the first 12 weeks of treatment, an additional antihypertensive agent could be added if required to achieve the target BP; the total treatment period was 28 or 52 weeks. The primary endpoint was a change from baseline in sitting BP. Of the 368 enrolled patients, 245 received monotherapy, and 59 and 64, respectively, took a CCB or RAS inhibitor concurrently. Mean changes from baseline in sitting systolic/diastolic BP (95% confidence intervals) at weeks 12, 28 and 52 were -16.1 (-17.3, -14.9)/-7.7 (-8.4, -6.9), -18.9 (-20.2, -17.7)/-9.9 (-10.7, -9.2), and -23.1 (-25.0, -21.1)/-12.5 (-13.6, -11.3) mmHg, respectively (all P < 0.0001 vs baseline). Similar BP reductions at these weeks were observed between all patient subgroups stratified by age, and the observed decreases in 24-h ambulatory BP were consistent with the efficacy observed in sitting BP. Esaxerenone was also well-tolerated with a rate of hyperkalemia at 5.4% (serum potassium ≥5.5 mEq/L), indicating a good safety profile for treatment over the long-term or in combination with a CCB or RAS inhibitor. In conclusion, esaxerenone may be a promising treatment option for patients with hypertension.",2019,"Mean changes from baseline in sitting systolic/diastolic BP (95% confidence intervals) at weeks 12, 28 and 52 were -16.1","['patients with hypertension', 'patients with essential hypertension', 'Japanese patients with essential hypertension', '368 enrolled patients, 245 received monotherapy, and 59 and 64, respectively, took a CCB or RAS inhibitor concurrently']","['Esaxerenone', 'CCB or RAS inhibitor', 'esaxerenone', 'esaxerenone as mono or combination therapy', 'calcium channel blocker (CCB) or a renin-angiotensin system (RAS) inhibitor']","['Similar BP reductions', '24-h ambulatory BP', 'change from baseline in sitting BP', 'rate of hyperkalemia', 'sitting systolic/diastolic BP', 'blood pressure (BP) targets']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0035096'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",368.0,0.0406456,"Mean changes from baseline in sitting systolic/diastolic BP (95% confidence intervals) at weeks 12, 28 and 52 were -16.1","[{'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Rakugi', 'Affiliation': 'Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. rakugi@geriat.med.osaka-u.ac.jp.'}, {'ForeName': 'Sadayoshi', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Division of Nephrology, Endocrinology and Vascular Medicine, Department of Medicine, Tohoku University School of Medicine, 2-1 Seiryo-machi, Aoba, Sendai, Miyagi, 980-8575, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': 'Department of Endocrinology, Metabolism and Nephrology, Keio University, School of Medicine, 35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Okuda', 'Affiliation': 'Daiichi Sankyo Co., Ltd., 1-2-58 Hiromachi, Shinagawa, Tokyo, 140-8710, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Yamakawa', 'Affiliation': 'Daiichi Sankyo Co., Ltd., 1-2-58 Hiromachi, Shinagawa, Tokyo, 140-8710, Japan.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0314-7']
630,31727347,Effects of Chinese square dancing on older adults with mild cognitive impairment.,"The present study aimed to explore the effects of square dancing on global cognition, depressive symptoms, balance, and quality of life of older adults with mild cognitive impairment. We studied 66 older adults with mild cognitive impairment in a large nursing home. Participants were assigned to the intervention group (n = 33) or the control group (n = 33), according to their residential floor, which was determined by coin tossing. The intervention group underwent a 12-week Chinese square dancing routine, while the control group maintained usual lifestyle (without square dancing). Outcomes were assessed at baseline and at weeks 6 and 12. The results showed positive effects of square dancing on all outcomes assessed, especially on depressive symptoms and quality of life-related mental well-being of the participants. This study showed that square dancing is a promising strategy for older adults with mild cognitive impairment and that long-term adherence can be beneficial.",2020,"The results showed positive effects of square dancing on all outcomes assessed, especially on depressive symptoms and quality of life-related mental well-being of the participants.","['66 older adults with mild cognitive impairment in a large nursing home', 'older adults with mild cognitive impairment']","['12-week Chinese square dancing routine, while the control group maintained usual lifestyle', 'Chinese square dancing', 'square dancing']","['global cognition, depressive symptoms, balance, and quality of life', 'depressive symptoms and quality of life-related mental']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0034380'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",66.0,0.0510252,"The results showed positive effects of square dancing on all outcomes assessed, especially on depressive symptoms and quality of life-related mental well-being of the participants.","[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, Jilin 130021, China.'}, {'ForeName': 'Huiru', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, Jilin 130021, China.'}, {'ForeName': 'Xiangfei', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, Jilin 130021, China.'}, {'ForeName': 'Binghan', 'Initials': 'B', 'LastName': 'Shang', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, Jilin 130021, China.'}, {'ForeName': 'Qiuyan', 'Initials': 'Q', 'LastName': 'Meng', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, Jilin 130021, China.'}, {'ForeName': 'Lufang', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, Jilin 130021, China.'}, {'ForeName': 'Lisheng', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, Jilin 130021, China. Electronic address: lishengwang@ymail.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun, Jilin 130021, China. Electronic address: chen_care@126.com.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2019.10.009']
631,31870338,"Impact of sunflower seed oil versus mustard seed oil on skin barrier function in newborns: a community-based, cluster-randomized trial.","BACKGROUND
Natural vegetable oils are widely used for newborn massage in many low resource settings. Animal models indicated that sunflower seed oil (SSO) can accelerate skin barrier recovery following damage, while other oils, including mustard oil (MO), may cause further skin barrier damage. The objective was to compare the effects of two SSO and MO used for routine massage on skin integrity in premature and full-term neonates.
METHODS
This community-based cluster randomized controlled trial included 995 neonates assigned to full body massage with sunflower seed oil (SSO, intervention) or mustard seed oil (MO, standard practice) from July 2012-May 2014 in Sarlahi, Nepal. Skin integrity measures were evaluated over 28 days, including skin condition (erythema, rash, dryness), skin surface pH, stratum corneum (SC) cohesion/protein concentration, and transepidermal water loss (TEWL). Overall means and rates of change in these skin measures were compared between oil groups using bivariate random-effects models.
RESULTS
500 and 495 live born neonates received repeated massage with MO and SSO, respectively. Skin pH decreased more quickly for SSO than MO in the first week of life, with a difference in mean daily reductions of 0.02 (95% CI: 0.002-0.040). Erythema, rash and dryness increased (worsened) over days 1-14 then decreased by day 28, with no significant oil group differences. TEWL increased over time, with no significant oil group differences. Gestational age did not modify the effect; the slightly faster decrease in skin pH among SSO infants was similar in magnitude between term and preterm infants.
CONCLUSIONS
Oil type may contribute to differences in skin integrity when neonates are massaged regularly. The more rapid acid mantle development observed for SSO may be protective for neonates in lower resource settings.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT01177111); registered August 6th, 2010.",2019,"Gestational age did not modify the effect; the slightly faster decrease in skin pH among SSO infants was similar in magnitude between term and preterm infants.
","['newborns', '995 neonates assigned to', 'premature and full-term neonates', '500 and 495 live born neonates']","['routine massage', 'SSO and MO', 'full body massage with sunflower seed oil (SSO, intervention) or mustard seed oil (MO, standard practice', 'sunflower seed oil versus mustard seed oil', 'sunflower seed oil (SSO']","['skin condition (erythema, rash, dryness), skin surface pH, stratum corneum (SC) cohesion/protein concentration, and transepidermal water loss (TEWL', 'skin pH', 'Skin integrity measures', 'Skin pH', 'skin barrier function', 'Erythema, rash and dryness', 'skin integrity']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0556844', 'cui_str': 'Body massage (regime/therapy)'}, {'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0453262', 'cui_str': 'Mustard seed (substance)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1719933', 'cui_str': 'Skin condition'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0221921', 'cui_str': 'Stratum corneum structure'}, {'cui': 'C1304757', 'cui_str': 'Finding of protein concentration, dipstick (finding)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0232445', 'cui_str': 'Skin pH (observable entity)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",995.0,0.194995,"Gestational age did not modify the effect; the slightly faster decrease in skin pH among SSO infants was similar in magnitude between term and preterm infants.
","[{'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Summers', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, W5009, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Marty O', 'Initials': 'MO', 'LastName': 'Visscher', 'Affiliation': ""Skin Sciences Program, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, W5009, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Jeevan B', 'Initials': 'JB', 'LastName': 'Sherchand', 'Affiliation': 'Department of Microbiology, Institute of Medicine, Tribhuvan University Teaching Hospital, Maharajgunj Rd, Kathmandu, 44600, Nepal.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'LeClerq', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, W5009, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, W5009, Baltimore, MD, 21205, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Department of Global Health, Milken Institute School of Public Health, George Washington University, 950 New Hampshire Avenue, Washington, DC, USA.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Mullany', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, W5009, Baltimore, MD, 21205, USA. lmullany@jhu.edu.'}]",BMC pediatrics,['10.1186/s12887-019-1871-2']
632,31736342,Sacubitril/Valsartan Across the Spectrum of Ejection Fraction in Heart Failure.,"BACKGROUND
While disease-modifying therapies exist for heart failure (HF) with reduced left ventricular ejection fraction (LVEF), few options are available for patients in the higher range of LVEF (>40%). Sacubitril/valsartan has been compared with a renin-angiotensin-aldosterone-system inhibitor alone in 2 similarly designed clinical trials of patients with reduced and preserved LVEF, permitting examination of its effects across the full spectrum of LVEF.
METHODS
We combined data from PARADIGM-HF (LVEF eligibility≤40%; n=8399) and PARAGON-HF (LVEF eligibility≥45%; n=4796) in a prespecified pooled analysis. We divided randomized patients into LVEF categories: ≤22.5% (n=1269), >22.5% to 32.5% (n=3987), >32.5% to 42.5% (n=3143), > 42.5% to 52.5% (n=1427), > 52.5% to 62.5% (n=2166), and >62.5% (n=1202). We assessed time to first cardiovascular death and HF hospitalization, its components, and total heart failure hospitlizations, all-cause mortality, and noncardiovascular mortality. Incidence rates and treatment effects were examined across categories of LVEF.
RESULTS
Among 13 195 randomized patients, we observed lower rates of cardiovascular death and HF hospitalization, but similar rates of noncardiovascular death, among patients in the highest versus the lowest groups. Overall sacubitril/valsartan was superior to renin-angiotensin-aldosterone-system inhibition for first cardiovascular death or heart failure hospitalization (Hazard Ratio [HR] 0.84 [95% CI, 0.78-0.90]), cardiovascular death (HR 0.84 [95% CI, 0.76-0.92]), heart failure hospitalization (HR 0.84 [95% CI, 0.77-0.91]), and all-cause mortality (HR 0.88 [95% CI, 0.81-0.96]). The effect of sacubitril/valsartan was modified by LVEF (treatment-by-continuous LVEF interaction P =0.02), and benefit appeared to be present for individuals with EF primarily below the normal range, although the treatment benefit for cardiovascular death diminished at a lower ejection fraction. We observed effect modification by LVEF on the efficacy of sacubitril/valsartan in both men and women with respect to composite total HF hospitalizations and cardiovascular death, although women derived benefit to higher ejection fractions.
CONCLUSIONS
The therapeutic effects of sacubitril/valsartan, compared with a renin-angiotensin-aldosterone-system inhibitor alone, vary by LVEF with treatment benefits, particularly for heart failure hospitalization, that appear to extend to patients with heart failure and mildly reduced ejection fraction. These therapeutic benefits appeared to extend to a higher LVEF range in women compared with men.
CLINICAL TRIAL REGISTRATION
https://www.clinicaltrials.gov. Unique identifiers: NCT01920711 (PARAGON-HF), NCT01035255 (PARADIGM-HF).",2020,"Overall sacubitril/valsartan was superior to RAS inhibition for first cardiovascular death or heart failure hospitalization (HR 0.84, 95% CI 0.78, 0.90), cardiovascular death (HR 0.84, 95% CI 0.76, 0.92), heart failure hospitalization (HR 0.84, 95% CI 0.77, 0.91), and all-cause mortality (HR 0.88, 95% CI 0.81, 0.96).","['patients with heart failure and mildly reduced ejection fraction', 'men and women with respect to composite total HF hospitalizations and cardiovascular death, although women derived benefit to higher ejection fractions', 'patients in the higher range of LVEF (>40', '13,195 randomized patients']","['Sacubitril/Valsartan', 'sacubitril/valsartan', 'Sacubitril/valsartan', 'LVEF']","['rates of non-cardiovascular death', 'cardiovascular death and HF hospitalization', 'time to first cardiovascular death and HF hospitalization, its components, and total heart failure hospitlizations, all-cause mortality and non-cardiovascular mortality', 'Incidence rates', 'heart failure hospitalization', 'RAS inhibition for first cardiovascular death or heart failure hospitalization', 'cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C3539085', 'cui_str': 'All'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",,0.115373,"Overall sacubitril/valsartan was superior to RAS inhibition for first cardiovascular death or heart failure hospitalization (HR 0.84, 95% CI 0.78, 0.90), cardiovascular death (HR 0.84, 95% CI 0.76, 0.92), heart failure hospitalization (HR 0.84, 95% CI 0.77, 0.91), and all-cause mortality (HR 0.88, 95% CI 0.81, 0.96).","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).""}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'L Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).""}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX (M.P.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina, Charleston (M.Z.).'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Sweden (K.S.).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Rouleau', 'Affiliation': 'Institut de Cardiologie de Montréal, Université de Montréal, Canada (J.R.).'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'A Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).""}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).""}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lund', 'Affiliation': 'Department of Medicine, Karolinska Institutet, and Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden (L.H.L.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kober', 'Affiliation': 'Department of Cardiology, Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark (L.K.).'}, {'ForeName': 'Inder', 'Initials': 'I', 'LastName': 'Anand', 'Affiliation': 'Department of Medicine, VA Medical Center and University of Minnesota, Minneapolis (I.A.).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Sweitzer', 'Affiliation': 'Sarver Heart Center, University of Arizona College of Medicine, Tucson (N.S.).'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Linssen', 'Affiliation': 'Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, The Netherlands (G.L.).'}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Luis Arango', 'Affiliation': 'Guatemalan Heart Institute (J.L.A.).'}, {'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Vinereanu', 'Affiliation': 'University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital of Bucharest, Romania (D.V.).'}, {'ForeName': 'Chen-Huan', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, National Yang-Ming University, Taipei, Taiwan, Republic of China (C.-H.C.).'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo, Italy (M.S.).'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Sibulo', 'Affiliation': ""St Luke's Heart Institute, St. Luke's Medical Center, Taguig, Philippines (A.S.).""}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Boytsov', 'Affiliation': 'National Research Center for Cardiology of the Ministry of Health of the Russian Federation, Moscow (S.B.).'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Shi', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ (V.S, A.R., M.L.).'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Rizkala', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ (V.S, A.R., M.L.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ (V.S, A.R., M.L.).'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, United Kingdom (J.J.V.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.044586']
633,31606398,Moderators of Internet-Delivered Cognitive-Behavioral Therapy for Adolescents With Chronic Pain: Who Benefits From Treatment at Long-Term Follow-Up?,"Cognitive behavioral therapy (CBT) is effective for pediatric chronic pain, but little is understood about which youth are most likely to benefit. The current study aimed to identify individual characteristics for which CBT yielded the greatest (and least) clinical benefit among adolescents with chronic pain participating in a multicenter randomized controlled trial of Internet-delivered CBT (WebMAP2). A total of 273 adolescents ages 11 to 17 with chronic pain (M age = 14.7; 75.1% female) were randomly assigned to Internet-delivered CBT or Internet-delivered pain education and evaluated at pretreatment, post-treatment, and 2 longer term follow-up periods (6 and 12 months). Multilevel growth models tested several adolescent- and parent-level moderators of change in pain-related disability including 1) adolescent age, sex, pain characteristics, distress, and sleep quality and 2) parent education level, distress, and protective parenting behavior. Younger adolescents (ages 11-14; vs older adolescents ages 15-17) and those whose parents experienced lower levels (vs higher levels) of emotional distress responded better to Internet CBT treatment, showing greater improvements in disability up to 12 months post-treatment. This study expands knowledge on who benefits most from Internet-delivered psychological treatment for youth with chronic pain in the context of a large multicenter randomized controlled trial, suggesting several avenues for maximizing treatment efficacy and durability in this population. PERSPECTIVE: This study identified adolescent- and parent-level predictors of treatment response to Internet-based CBT for pediatric chronic pain up to 12 months later. Younger adolescents and those whose parents had lower levels of distress may particularly benefit from this intervention. Older adolescents and those whose parents exhibit higher distress may require alternative treatment approaches.",2020,"Young adolescents (ages 11-14 vs. older adolescents ages 15-17) and those whose parents experienced lower levels (vs. higher levels) of emotional distress responded better to internet CBT treatment, showing greater improvements in disability up to 12 months post-treatment.","['Young adolescents (ages 11-14 vs. older adolescents ages 15-17', 'Older adolescents', 'adolescents with chronic pain participating in a multi-center randomized controlled trial (RCT) of', '273 adolescents ages 11-17 with chronic pain (Mage=14.7; 75.1% female', 'adolescents with chronic pain', 'Younger adolescents', 'youth with chronic pain']","['internet-delivered cognitive-behavioral therapy', 'Internet-based CBT', 'internet-delivered CBT (WebMAP2', 'Cognitive-behavioral therapy (CBT', 'internet-delivered CBT or internet-delivered pain education and evaluated at pre-treatment, post-treatment']","['pain-related disability including (1) adolescent age, sex, pain characteristics, distress, and sleep quality and (2) parent education level, distress, and protective parenting behaviors', 'disability', 'emotional distress']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0242261', 'cui_str': 'Parenting Education'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",273.0,0.0873187,"Young adolescents (ages 11-14 vs. older adolescents ages 15-17) and those whose parents experienced lower levels (vs. higher levels) of emotional distress responded better to internet CBT treatment, showing greater improvements in disability up to 12 months post-treatment.","[{'ForeName': 'Caitlin B', 'Initials': 'CB', 'LastName': 'Murray', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington. Electronic address: caitlin.murray@seattlechildrens.org.""}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'de la Vega', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Dorothy M', 'Initials': 'DM', 'LastName': 'Loren', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington; Loyola University Chicago, Chicago, Illinois.""}, {'ForeName': 'Tonya M', 'Initials': 'TM', 'LastName': 'Palermo', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington; University of Washington, Seattle, Washington.""}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.10.001']
634,31081360,"Does red orange juice supplementation has a protective effect on performance, cardiovascular parameters, muscle damage and oxidative stress markers following the Yo-Yo Intermittent Recovery Test Level-1 under polluted air?","This study aimed to investigate the effect of red orange juice supplementation (ROJS) on performance, cardiovascular parameters, muscle damage and oxidative stress markers of athletes following exercise under polluted air. Eleven soccer players performed a Yo-Yo Intermittent Recovery Test Level-1 in polluted area (PA) and non-polluted area (NPA). Participants are invited to drink 500 ml of red orange or placebo (PLA) juice 2.5 h before the test. Blood samples were collected at rest and 3 min after each session to assess creatine kinase (CK), lactate dehydrogenase, malondialdehyde (MDA) and total antioxidant status. Our results showed that, VO 2max , heart rate and systolic blood pressure post-exercise were significantly altered by pollution with both supplements, but the damage was lowered more with ROJS than PLA. Concerning muscle damage and oxidative stress markers, orange juice supplementation blunted the effect of pollution on CK levels post-exercise ( p > 0.05) and decreases significantly ( p < 0.05) the MDA levels post-exercise in PA and NPA compared to PLA supplementation. In conclusion, ROJS seemed to be an appropriate strategy to reduce the risk of exposure to pollution especially on muscle damage and oxidative stress markers.",2020,"Concerning muscle damage and oxidative stress markers, orange juice supplementation blunted the effect of pollution on CK levels post-exercise (p > 0.05) and decreases significantly (p < 0.05) the MDA levels post-exercise in PA and NPA compared to PLA supplementation.","['Eleven soccer players performed a Yo-Yo Intermittent Recovery Test Level-1 in polluted area (PA) and non-polluted area (NPA', 'athletes following exercise under polluted air']","['drink 500\xa0ml of red orange or placebo (PLA) juice', 'red orange juice supplementation (ROJS', 'red orange juice supplementation']","['Blood samples', 'VO 2max , heart rate and systolic blood pressure post-exercise', 'CK levels post-exercise', 'performance, cardiovascular parameters, muscle damage and oxidative stress markers', 'creatine kinase (CK), lactate dehydrogenase, malondialdehyde (MDA) and total antioxidant status']","[{'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0001873', 'cui_str': 'Air Pollution'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0440277', 'cui_str': 'Oranges'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.230688,"Concerning muscle damage and oxidative stress markers, orange juice supplementation blunted the effect of pollution on CK levels post-exercise (p > 0.05) and decreases significantly (p < 0.05) the MDA levels post-exercise in PA and NPA compared to PLA supplementation.","[{'ForeName': 'Nesrine', 'Initials': 'N', 'LastName': 'Boussetta', 'Affiliation': 'High Institute of Sport and Physical Education, University of Manouba , Manouba, Tunisia.'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Abedelmalek', 'Affiliation': 'Department of Physiology and functional explorations, Sousse Faculty of Medicine, University of Sousse , Sousse, Tunisia.'}, {'ForeName': 'Aloui', 'Initials': 'A', 'LastName': 'Khouloud', 'Affiliation': 'Faculty of Sciences of Bizerte, University of Carthage , Bizerte, Tunisia.'}, {'ForeName': 'Amel', 'Initials': 'A', 'LastName': 'Ben Anes', 'Affiliation': 'Research Unit UR12ES06, Physiology of Exercise and Physiopathology: from Integrated to Molecular ""Biology, Medicine and Health"", Faculty of Medicine of Sousse, University of Sousse , Sousse, Tunisia.'}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Souissi', 'Affiliation': 'High Institute of Sport and Physical Education, University of Manouba , Manouba, Tunisia.'}]",International journal of environmental health research,['10.1080/09603123.2019.1614155']
635,31730174,Low Circulating Levels of miR-451a in Girls with Polycystic Ovary Syndrome: Different Effects of Randomized Treatments.,"CONTEXT
Polycystic ovary syndrome (PCOS) is a prevalent disorder in adolescent girls, purportedly driven by hepato-visceral fat excess, and often followed by subfertility and type 2 diabetes.
OBJECTIVE
We studied the baseline microRNA (miRNA) profile of girls with PCOS, and the effects of a randomized treatment with an oral contraceptive (OC) or with spironolactone-pioglitazone-metformin (SPIOMET, aiming at loss of hepato-visceral fat excess) for 1 year.
DESIGN & PATIENTS
The miRNA profile was assessed by RNA sequencing in girls with PCOS who had participated in a randomized, open-label, single-center, pilot study (n = 31; age 15.7 years, body mass index (BMI) 23.1 kg/m2). Healthy age- and BMI-matched girls (n = 13) served as controls. Differentially expressed miRNAs were validated by RT-qPCR in the entire study population. Post-treatment ovulation rates were assessed by salivary progesterone in PCOS girls.
SETTING
Endocrinology Department, University Hospital.
RESULTS
Girls with PCOS, compared with controls, had markedly reduced concentrations of circulating miR-451a, miR-652-3p, miR-106b-5p, and miR-206; pathway enrichment analysis showed that these miRNAs target genes involved in energy homeostasis and cell cycle control. In the present study, miR-451a could diagnose PCOS with 100% sensitivity and 100% specificity. SPIOMET (but not OC) was accompanied by on-treatment normalization of the miRNA profile in girls with PCOS; miR-451a concentrations after 1 year on OC or SPIOMET treatment associated closely (r = 0.66; P < .0001) with post-treatment ovulation rates.
CONCLUSION
SPIOMET treatment for 1 year normalizes the miRNA profile of girls with PCOS. Circulating miR-451a may become a biomarker to guide the diagnosis and treatment of PCOS in adolescence.",2020,"RESULTS
Girls with PCOS -as compared to controls- had markedly reduced concentrations of circulating miR-451a, miR-652-3p, miR-106b-5p and miR-206; pathway enrichment analysis showed that these miRNAs target genes involved in energy homeostasis and cell-cycle control.","['girls with PCOS', 'Girls with Polycystic Ovary Syndrome', 'girls with PCOS who had participated in a randomized, open-label, single-center, pilot study (n=31; age 15.7 years, BMI 23.1 Kg/m2', 'Endocrinology Department, University Hospital', '1 year normalizes the miRNA profile of girls with PCOS', 'Healthy age- and BMI-matched girls (n=13) served as controls']",['oral contraceptive (OC) or with spironolactone-pioglitazone-metformin'],['Post-treatment ovulation rates'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0587463', 'cui_str': 'Endocrinology department (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1101610', 'cui_str': 'miRNA'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}]",,0.0900779,"RESULTS
Girls with PCOS -as compared to controls- had markedly reduced concentrations of circulating miR-451a, miR-652-3p, miR-106b-5p and miR-206; pathway enrichment analysis showed that these miRNAs target genes involved in energy homeostasis and cell-cycle control.","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Díaz', 'Affiliation': 'Institut de Recerca Pediàtric Hospital Sant Joan de Déu, University of Barcelona, Esplugues, Barcelona, Spain.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Bassols', 'Affiliation': 'Maternal-Fetal Metabolic Research Group, Girona Institute for Biomedical Research (IDIBGI), Salt, Spain.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'López-Bermejo', 'Affiliation': 'Pediatric Endocrinology Research Group, Girona Institute for Biomedical Research (IDIBGI) and Dr. Josep Trueta Hospital, Girona, Spain.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'de Zegher', 'Affiliation': 'Department of Development & Regeneration, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Ibáñez', 'Affiliation': 'Institut de Recerca Pediàtric Hospital Sant Joan de Déu, University of Barcelona, Esplugues, Barcelona, Spain.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz204']
636,31727915,Safety profile of sedative endoscopy including cognitive performance in liver cirrhosis: A double-blind randomized controlled trial.,"The indiscriminate use of sedative drugs during endoscopy can pose multiple risks including cognitive impairment in advanced liver cirrhosis. However, the data are scarce regarding which sedative drugs are safest in these populations. The aim of this study was to evaluate the safety profiles including cognitive performance among midazolam, propofol, and combination therapy in advanced cirrhotic patients. This double-blind randomized controlled study included 60 consecutive advanced cirrhotic patients who underwent upper gastrointestinal endoscopy. The Stroop application was used to screen for cognitive impairment. Patients were randomly assigned to one of 3 groups, midazolam, propofol, or the combination group, and underwent Stroop test before and two hours after the completion of endoscopy. Hemodynamic safety and the subjective satisfaction score were also evaluated. Patients did not show significant changes in on-time or off-time on the Stroop test before and two hours after sedatives, and there was no significant difference among the 3 treatment groups. Also, there were no significant vital sign changes after sedatives. Time-to-recovery was longest in midazolam group, and patient awakening and patient memory were highest in propofol group. However, all 3 groups showed no difference in patient satisfaction, but the combination group was more preferred in terms of subjective satisfaction by physicians. Factors affecting worsened Stroop speed after sedatives were older age, low education level and high MELD score. All sedative methods using midazolam, propofol, or combination therapy showed similar safety profile in advanced cirrhosis, and were not associated with increased risk of cognitive impairment.",2019,"Patients did not show significant changes in on-time or off-time on the Stroop test before and two hours after sedatives, and there was no significant difference among the 3 treatment groups.","['advanced cirrhotic patients', 'liver cirrhosis', 'advanced liver cirrhosis', '60 consecutive advanced cirrhotic patients who underwent upper gastrointestinal endoscopy']","['sedative endoscopy', 'midazolam, propofol, or combination therapy', 'midazolam', 'midazolam, propofol, and combination therapy', 'midazolam, propofol, or the combination group, and underwent Stroop test']","['Hemodynamic safety and the subjective satisfaction score', 'Time-to-recovery', 'cognitive performance', 'subjective satisfaction', 'risk of cognitive impairment', 'patient satisfaction', 'time or off-time on the Stroop test']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}]","[{'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}]",60.0,0.135558,"Patients did not show significant changes in on-time or off-time on the Stroop test before and two hours after sedatives, and there was no significant difference among the 3 treatment groups.","[{'ForeName': 'Jeong-Ju', 'Initials': 'JJ', 'LastName': 'Yoo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University school of medicine Bucheon Hospital, Bucheon, Korea.'}, {'ForeName': 'Hyeon Jeong', 'Initials': 'HJ', 'LastName': 'Goong', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University school of medicine Bucheon Hospital, Bucheon, Korea.'}, {'ForeName': 'Ji Eun', 'Initials': 'JE', 'LastName': 'Moon', 'Affiliation': 'Department of Biostatistics, Clinical Trial Center, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.'}, {'ForeName': 'Sang Gyune', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University school of medicine Bucheon Hospital, Bucheon, Korea.'}, {'ForeName': 'Young Seok', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University school of medicine Bucheon Hospital, Bucheon, Korea. liverkys@schmc.ac.kr.'}]",Scientific reports,['10.1038/s41598-019-52897-w']
637,31727962,Taxane-based Chemotherapy Induced Androgen Receptor Splice Variant 7 in Patients with Castration-Resistant Prostate Cancer: A Tissue-based Analysis.,"In total, 95 prostate cancer (Pca) patients who underwent transurethral resection of the prostate from 2000 to 2013 were assigned to four groups: Group 1, hormone-naïve and T1a or T1b Pca (n = 17); Group 2, hormone-sensitive and metastatic Pca (n = 33); Group 3, chemo-naïve castration-resistant Pca (CRPC), (n = 18); and Group 4, CRPC with chemotherapy (n = 27). Full-length androgen receptor (ARfl) transcript levels significantly increased from Group 1 through to Group 3 (p = 0.045), but decreased from Group 3 through to Group 4. AR splice variant 7 (ARV7) and glucocorticoid receptor (GR) transcript levels significantly increased from Group 1 through to Group 4 (p = 0.002 and 0.049, respectively). Kaplan-Meier curve revealed that the high transcript level of these three receptors resulted in significantly poorer cancer-specific survival (CSS) than that by low transcript level, although Cox regression analysis revealed that the ARV7 level alone was an independent prognostic factor for CSS in CRPC patients (high vs. low: hazard ratio, 1.897; 95% confidence interval, 1.102-3.625; p = 0.042). In conclusion, ARV7 and GR transcript levels significantly increase as Pca progresses to CRPC.",2019,"ARfl) transcript levels significantly increased from Group 1 through to Group 3 (p = 0.045), but decreased from Group 3 through to Group 4.","['95 prostate cancer (Pca) patients who underwent transurethral resection of the prostate from 2000 to 2013', 'Patients with Castration-Resistant Prostate Cancer']","['hormone-naïve and T1a or T1b', 'CRPC with chemotherapy', 'chemo-naïve castration-resistant Pca (CRPC', 'Taxane-based Chemotherapy', 'Full-length androgen receptor ']","['ARV7 and GR transcript levels', 'ARfl) transcript levels', 'poorer cancer-specific survival (CSS', 'AR splice variant 7 (ARV7) and glucocorticoid receptor (GR) transcript levels']","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}]","[{'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0034786', 'cui_str': 'Testosterone Receptor'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0034809', 'cui_str': 'Glucocorticoid Receptor'}]",2013.0,0.0268213,"ARfl) transcript levels significantly increased from Group 1 through to Group 3 (p = 0.045), but decreased from Group 3 through to Group 4.","[{'ForeName': 'Myungsun', 'Initials': 'M', 'LastName': 'Shim', 'Affiliation': 'Department of Urology, Hallym University College of Medicine, Hallym University Sacred Heart Hospital, 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14068, South Korea.'}, {'ForeName': 'Yunlim', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Institute for Innovative Cancer Research, Asan Institute for Life Science, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Yangsoon', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Department of Pathology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Hanjong', 'Initials': 'H', 'LastName': 'Ahn', 'Affiliation': 'Department of Urology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea. hjahn@amc.seoul.kr.'}]",Scientific reports,['10.1038/s41598-019-53280-5']
638,31728731,Efficiency of desensitizing materials in xerostomic patients with head and neck cancer: a comparative clinical study.,"OBJECTIVES
To assess the clinical effectiveness of four desensitizing materials in patients who are xerostomic due to radiotherapy for head and neck cancer (HNC) in comparison to a healthy group with normal salivation.
METHODS AND MATERIALS
The study was conducted as a split-mouth randomized clinical trial. Forty HNC patients (group A) and 46 healthy patients (group B) suffering from dentin hypersensitivity (DH) were included. Salivary flow was determined through a scialometric test. Hypersensitivity was assessed with air stimulus and tactile stimulus. The materials used as desensitizing agents were Vertise Flow, Universal Dentin Sealant, Clearfil Protect Bond, and Flor-Opal Varnish. The response was recorded before application of the materials, immediately after, and at 1 week, 4 weeks, and 12 weeks.
RESULTS
Salivary flow rates in groups A/B were 0.15/0.53 mL/min (unstimulated) and 0.54/1.27 mL/min (stimulated), respectively. In group A, 100 hypersensitive teeth were included. Application of the desensitizing agents significantly decreased the hypersensitivity immediately and throughout the 4-week follow-up (p < 0.001). However, after the 12-week timepoint, a loss of efficacy was detected in all agents (p = 0.131). In group B, 116 hypersensitive teeth were included. The materials performed a more stable action, although a loss of effectiveness was detected at 12-week control (p = 0.297).
CONCLUSION
The efficiency of the desensitizing agents after the first application was similar in both groups. In the radiated group, this effect lasted for shorter periods than in healthy controls.
CLINICAL RELEVANCE
HNC patients with hyposalivation may be a new risk group for DH.",2020,Application of the desensitizing agents significantly decreased the hypersensitivity immediately and throughout the 4-week follow-up (p < 0.001).,"['100 hypersensitive teeth were included', 'patients who are xerostomic due to radiotherapy for head and neck cancer (HNC) in comparison to a healthy group with normal salivation', 'Forty HNC patients (group A) and 46 healthy patients (group B) suffering from dentin hypersensitivity (DH) were included', 'xerostomic patients with head and neck cancer', '116 hypersensitive teeth were included', 'HNC patients with hyposalivation may be a new risk group for DH']",['desensitizing materials'],"['hypersensitivity', 'Hypersensitivity', 'loss of efficacy', 'Salivary flow']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0576991', 'cui_str': 'Normal salivation (finding)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0011432', 'cui_str': 'Tooth Sensitivity'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C1278418', 'cui_str': 'MAY BE A'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}]",,0.01637,Application of the desensitizing agents significantly decreased the hypersensitivity immediately and throughout the 4-week follow-up (p < 0.001).,"[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pinna', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Sassari, Italy. rpinna@uniss.it.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Milia', 'Affiliation': 'Department of Medicine, Surgery and Experimental Science, University of Sassari, Sassari, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Usai', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Crivelli', 'Affiliation': 'Department of Medicine, Surgery and Experimental Science, University of Sassari, Sassari, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pagano', 'Affiliation': 'Department of Surgical and Biomedical Sciences, University of Perugia, Perugia, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sotgiu', 'Affiliation': 'Department of Medicine, Surgery and Experimental Science, University of Sassari, Sassari, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schmalz', 'Affiliation': 'Department of Conservative and Operative Dentistry, University Hospital Regensburg, Regensburg, Germany.'}]",Clinical oral investigations,['10.1007/s00784-019-03081-x']
639,29982097,Handgrip exercise reduces peripherally-inserted central catheter-related venous thrombosis in patients with solid cancers: A randomized controlled trial.,"BACKGROUND
Peripherally-inserted central catheter-related venous thrombosis has serious complications including the loss of vascular access, recurrent venous thrombosis, and post-thrombotic syndrome. Current guidelines recommend non-pharmacological strategies to prevent peripherally-inserted central catheter-related venous thrombosis. There is little evidence for the effectiveness of handgrip exercise on the prevention of peripherally-inserted central catheter-related venous thrombosis.
OBJECTIVES
To examine the effectiveness of handgrip exercise using an elastic ball to prevent peripherally-inserted central catheter-related venous thrombosis in patients with solid cancers.
DESIGN
A randomized controlled trial.
SETTINGS
One teaching hospital in Nanjing, China.
PARTICIPANTS
In total, 120 subjects with solid cancers were eligible; each had a new peripherally-inserted central catheter. They were recruited and randomly assigned into two exercise groups and one control group.
METHODS
Subjects from exercise groups 1 and 2 performed a 3-week, 25-repetition handgrip exercise, 3 and 6 times daily, respectively. The control group subjects performed a gentle limb exercise with no frequency and intensity requirements. Ultrasound was used to detect venous thrombosis development and examine axillary vein blood flow over the three points.
RESULTS
There were 32 cases of peripherally-inserted central catheter-related venous thrombosis detected. Two venous thrombosis cases in the control group were symptomatic, but all venous thrombosis cases in the exercise groups were asymptomatic. All venous thromboses were partial. There were significant differences in the incidence of venous thrombosis among the three groups (χ 2 = 12.813, p = 0.002; χ 2 = 9.340, p = 0.009; χ 2 = 11.480, p = 0.003; and χ 2 = 10.534, p = 0.005, respectively) at days 2, 3 and 21. The incidence of venous thrombosis in the two exercise groups was lower than that in the control group over the 3 time points (all, p < 0.05). The between-group effects and interaction effect in vein maximum velocity and time-mean flow velocity showed significant differences (F = 4.180, p = 0.025; F = 4.010, p = 0.045; and F = 2.928, p = 0.025) at days 2, 3, and 21, respectively. The axillary vein blood flow parameters in the control group were lower than those in the two exercise groups at day 21 (all, p < 0.05). However, no significant differences occurred in the incidence of venous thrombosis and axillary vein blood flow parameters between the two exercise groups.
CONCLUSION
Handgrip exercise using an elastic ball daily for three weeks could decrease the incidence of peripherally-inserted central catheter-related venous thrombosis. The method is simple, with no negative consequence reported. Further studies are required to confirm this conclusion and to explore the optimal frequency of handgrip exercise.",2018,"The incidence of venous thrombosis in the two exercise groups was lower than that in the control group over the 3 time points (all, p < 0.05).","['One teaching hospital in Nanjing, China', 'patients with solid cancers', 'Subjects from exercise groups 1 and 2 performed a 3-week', '120 subjects with solid cancers were eligible; each had a new peripherally-inserted central catheter']","['Handgrip exercise reduces peripherally-inserted central catheter-related venous thrombosis', 'handgrip exercise', '25-repetition handgrip exercise', 'Handgrip exercise', 'gentle limb exercise with no frequency and intensity requirements']","['incidence of venous thrombosis and axillary vein blood flow parameters', 'axillary vein blood flow parameters', 'venous thrombosis development and examine axillary vein blood flow', 'vein maximum velocity and time-mean flow velocity', 'incidence of venous thrombosis', 'incidence of peripherally-inserted central catheter-related venous thrombosis']","[{'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0179740', 'cui_str': 'Long line'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0179740', 'cui_str': 'Long line'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0042487', 'cui_str': 'Phlebothrombosis'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0042487', 'cui_str': 'Phlebothrombosis'}, {'cui': 'C0004456', 'cui_str': 'Axillary Vein'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0179740', 'cui_str': 'Long line'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",120.0,0.0775014,"The incidence of venous thrombosis in the two exercise groups was lower than that in the control group over the 3 time points (all, p < 0.05).","[{'ForeName': 'Kouying', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Respiratory Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China; School of Nursing, Nanjing Medical University, Nanjing, China. Electronic address: liuky188@126.com.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'School of Nursing, Nanjing Medical University, Nanjing, China; Chinese Nursing Association, Beijing, China. Electronic address: yeyecrystal@126.com.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Department of Respiratory Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. Electronic address: wpxie@njmu.edu.cn.'}, {'ForeName': 'Zejuan', 'Initials': 'Z', 'LastName': 'Gu', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. Electronic address: jassicagu@163.com.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Department of Respiratory Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. Electronic address: ez1104@126.com.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Department of Ultrasonography, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. Electronic address: yexh-0125@163.com.'}, {'ForeName': 'Xuesong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Respiratory Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. Electronic address: lancetchen@163.com.'}, {'ForeName': 'Boqiang', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': 'Department of Oncology Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. Electronic address: Bq_fan@139.com.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. Electronic address: hongwang@njmu.edu.cn.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'School of Nursing, Nanjing Medical University, Nanjing, China. Electronic address: cyan@njmu.edu.cn.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2018.06.004']
640,30408271,A neuromarker of clinical outcome in attention bias modification therapy for social anxiety disorder.,"BACKGROUND
Attention bias modification (ABM) therapy aims to modify threat-related attention patterns via computerized tasks. Despite showing medium clinical effect sizes for anxiety disorders, underlying neural-cognitive mechanisms of change remain unclear. We used visual mismatch negativity (vMMN), an event-related potential sensitive to violations of learned statistical contingencies, to assess therapy-related contingency extraction processes in healthy participants and in patients with social anxiety disorder (SAD). We then assessed whether vMMN amplitude predicts ABM treatment outcome.
METHODS
A modified version of the dot-probe task was used to elicit vMMN, in which 80% of trials were standard and 20% were deviant. In study 1, 30 healthy adults were randomly assigned to one of two ABM conditions: one in which threat-congruent targets were deviant trials and threat-incongruent targets were standard trials, and another in which the contingency was reversed. Electroencephalography (EEG) was continuously measured and vMMN analyzed. In study 2, 38 patients with SAD underwent six sessions of ABM therapy. We tested whether rule extraction in the ABM task, indicated by vMMN amplitude, predicts treatment outcome.
RESULTS
vMMN clearly emerged over prespecified scalp locations indicating contingency extraction during ABM (study 1). vMMN amplitude predicted clinical improvement after ABM therapy, uniquely accounting for 7% and 14.4% of the variance in clinician-rated and self-reported posttreatment SAD symptoms, respectively.
CONCLUSIONS
vMMN emerges as a neural marker for contingency learning in ABM, suggesting a significant role for contingency extraction processes in the clinical efficacy of this therapy.",2019,"We used visual mismatch negativity (vMMN), an event-related potential sensitive to violations of learned statistical contingencies, to assess therapy-related contingency extraction processes in healthy participants and in patients with social anxiety disorder (SAD).","['healthy participants and in patients with social anxiety disorder (SAD', '38 patients with SAD underwent six sessions of ABM therapy', 'social anxiety disorder', '30 healthy adults']","['Attention bias modification (ABM) therapy', 'visual mismatch negativity (vMMN']",['Electroencephalography (EEG'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}]",30.0,0.076146,"We used visual mismatch negativity (vMMN), an event-related potential sensitive to violations of learned statistical contingencies, to assess therapy-related contingency extraction processes in healthy participants and in patients with social anxiety disorder (SAD).","[{'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Arad', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Rany', 'Initials': 'R', 'LastName': 'Abend', 'Affiliation': 'Section on Development and Affective Neuroscience, National Institute of Mental Health, Bethesda, Maryland.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Pine', 'Affiliation': 'Section on Development and Affective Neuroscience, National Institute of Mental Health, Bethesda, Maryland.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Bar-Haim', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}]",Depression and anxiety,['10.1002/da.22858']
641,31038430,"A randomized pilot study of music therapy in the form of patient-preferred live music on fatigue, energy and pain in hospitalized adult oncology patients on a blood and marrow transplant unit.","INTRODUCTION
There is a lack of randomized research measuring how music therapy might influence fatigue in oncology patients.
OBJECTIVE
The purpose of this randomized pilot study was to evaluate the effects of music therapy in the form of patient-preferred live music (PPLM) on fatigue, energy and pain in adults hospitalized on a blood and marrow transplant (BMT) unit.
METHOD
Participants ( n = 35) were randomly assigned to an experimental or wait-list control group and completed the Lee Fatigue Scale and a 10-point Likert-type pain scale at pre- and posttest.
RESULTS
Between-group posttest results were statistically significant for fatigue and pain, with the experimental group having less fatigue and pain than the control group.
CONCLUSIONS
PPLM can be a preferred and effective intervention to immediately lessen fatigue and pain without pharmacological intervention. Implications for clinical practice, limitations and suggestions for future research are provided.",2020,"RESULTS
Between-group posttest results were statistically significant for fatigue and pain, with the experimental group having less fatigue and pain than the control group.
","['oncology patients', 'Participants (n\xa0=\xa035', 'hospitalized adult oncology patients on a blood and marrow transplant unit', 'adults hospitalized on a blood and marrow transplant (BMT) unit']","['music therapy', 'patient-preferred live music (PPLM']","['Lee Fatigue Scale and a 10-point Likert-type pain scale', 'fatigue and pain', 'fatigue, energy and pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005768'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0026868', 'cui_str': 'Music Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3543840', 'cui_str': 'Preferred'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0222045'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",35.0,0.0469403,"RESULTS
Between-group posttest results were statistically significant for fatigue and pain, with the experimental group having less fatigue and pain than the control group.
","[{'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Reimnitz', 'Affiliation': 'School of Music, University of Minnesota , Minneapolis, MN, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Silverman', 'Affiliation': 'School of Music, University of Minnesota , Minneapolis, MN, USA.'}]",Arts & health,['10.1080/17533015.2018.1534251']
642,31066887,Efficacy of Adjunctive Infliximab vs Placebo in the Treatment of Adults With Bipolar I/II Depression: A Randomized Clinical Trial.,"Importance
To our knowledge, no study has previously evaluated whether individuals with bipolar depression enriched a priori on the basis of biochemical and/or phenotypic immuno-inflammatory activation would differentially respond to an anti-inflammatory agent for the treatment of depressive symptoms.
Objective
To assess the antidepressant efficacy of adjunctive infliximab, a monoclonal antibody targeting tumor necrosis factor, in adults with bipolar I and bipolar II depression and inflammatory conditions.
Design, Setting, and Participants
This 12-week, randomized, double-blind, placebo-controlled, parallel-group trial of 60 participants was conducted at 2 outpatient tertiary care sites in Canada and the United States. Eligible adults (aged 18-65 years) met DSM-5-defined criteria for bipolar I or bipolar II depression and exhibited pretreatment biochemical and/or phenotypic evidence of inflammatory activation. Participants were enrolled between October 1, 2015, and April 30, 2018. Data analysis was performed from May 1 through July 31, 2018, using modified intent-to-treat analysis.
Interventions
Patients were randomized to receive 3 intravenous infusions of infliximab therapy or placebo at baseline and at weeks 2 and 6 of the 12-week study.
Main Outcomes and Measures
The primary efficacy outcome was baseline-to-end point (ie, week-12) change in Montgomery-Asberg Depression Rating Scale (MADRS) total score. History of childhood maltreatment, as assessed by the Childhood Trauma Questionnaire, was used for exploratory analyses as 1 of several secondary outcomes.
Results
A total of 60 participants were randomized to infliximab (n = 29 [48%]; mean [SD] age, 45.0 [11.7] years; 20 of 28 female [71%]) or to placebo (n = 31 [52%]; mean [SD] age, 46.8 [10.2] years; 26 of 30 female [87%]) across study sites. Overall baseline-to-end point change in MADRS total score was observed across treatment × time interaction (χ2 = 10.33; P = .04); reduction in symptom severity was not significant at week 12 (relative risk, 1.09; 95% CI, 0.80-1.50; df = 1; P = .60). As part of a secondary analysis, a significant treatment × time × childhood maltreatment interaction was observed in which infliximab-treated individuals with childhood history of physical abuse exhibited greater reductions in MADRS total score (χ2 = 12.20; P = .02) and higher response rates (≥50% reduction in MADRS total score) (χ2 = 4.05; P = .04).
Conclusions and Relevance
Infliximab did not significantly reduce depressive symptoms compared with placebo in adults with bipolar depression. Results from secondary analyses identified a subpopulation (ie, those reporting physical and/or sexual abuse) that exhibited a significant reduction in depressive symptoms with infliximab treatment compared with placebo.
Trial Registration
ClinicalTrials.gov identifier: NCT02363738.",2019,"P = .04); reduction in symptom severity was not significant at week 12 (relative risk, 1.09; 95% CI, 0.80-1.50; df = 1; P = .60).","['mean [SD] age, 45.0 [11.7] years; 20 of 28 female [71%]) or to', 'Adults With Bipolar I/II Depression', 'Eligible adults (aged 18-65 years) met DSM-5-defined criteria for bipolar I or bipolar II depression and exhibited pretreatment biochemical and/or phenotypic evidence of inflammatory activation', 'individuals with bipolar depression', 'A total of 60 participants', 'n\u2009=\u200931 [52%]; mean [SD] age, 46.8 [10.2] years; 26 of 30 female [87%]) across study sites', 'Participants were enrolled between October 1, 2015, and April 30, 2018', '60 participants was conducted at 2 outpatient tertiary care sites in Canada and the United States', 'adults with bipolar depression', 'adults with bipolar I and bipolar II depression and inflammatory conditions']","['infliximab therapy or placebo', 'adjunctive infliximab', 'Adjunctive Infliximab vs Placebo', 'placebo', 'infliximab']","['symptom severity', 'depressive symptoms', 'MADRS total score', 'response rates', 'baseline-to-end point (ie, week-12) change in Montgomery-Asberg Depression Rating Scale (MADRS) total score']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517535', 'cui_str': '11.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C4076075', 'cui_str': 'Infliximab therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]",60.0,0.457257,"P = .04); reduction in symptom severity was not significant at week 12 (relative risk, 1.09; 95% CI, 0.80-1.50; df = 1; P = .60).","[{'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Mehala', 'Initials': 'M', 'LastName': 'Subramaniapillai', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Zihang', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Carmona', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Shekotikhina', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Rosenblat', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Joanna K', 'Initials': 'JK', 'LastName': 'Soczynska', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, California.'}, {'ForeName': 'Shefali', 'Initials': 'S', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, California.'}, {'ForeName': 'Eileen Grace', 'Initials': 'EG', 'LastName': 'Fischer', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, California.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, California.'}, {'ForeName': 'Kiley', 'Initials': 'K', 'LastName': 'Dunlap', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, California.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, California.'}, {'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.0779']
643,32410703,Urinary angiotensinogen as a surrogate marker predicting the antiproteinuric effects of angiotensin receptor blockers in patients with overt proteinuria: a multicenter prospective study.,"BACKGROUND
Although urinary angiotensinogen (AGT) and renin reflect intrarenal renin-angiotensin system activity and are enhanced in proteinuric chronic kidney disease, the clinical value of urinary AGT and renin levels during antiproteinuric treatment has yet to be determined. We investigated the clinical usefulness of initial urinary AGT or renin to determine the antiproteinuric effects of angiotensin receptor blockers (ARBs).
METHODS
This multicenter, prospective, single-arm study included 205 patients with overt proteinuria (urinary protein/creatinine ratio [uPCR] ≥ 1 mg/mg) enrolled between April 2009 and December 2011. All patients were treated with valsartan. The urinary AGT/creatinine ratio (uAGT/Cr) was measured at the baseline and 24 weeks, and the renin/creatinine ratio (uR/Cr) was measured at the baseline. Fifty-six patients were followed-up for 5 years.
RESULTS
The mean age was 47.6 years and 51.2% were male. The mean uPCR was 2.32 mg/mg and the mean eGFR was 63.2 mL/min/1.73m 2 . Natural logarithms (ln) (uAGT/Cr), ln(uR/Cr), and diabetes mellitus were associated with proteinuria decrement (decrease in uPCR ≥1 mg/mg). Ln(uAGT/Cr) was an independent predictor for proteinuria decrement (OR 1.372, 95% CI, 1.068-1.762, P = 0.013). Among the 56 patients followed-up for 5 years, Δln(uAGT/Cr) at 24 weeks was an independent predictor for uPCR < 1 mg/mg at 5 years (OR 0.379, 95% CI, 0.20-0.715, P = 0.003).
CONCLUSIONS
Our study demonstrates the potential role of both baseline urinary AGT and changes in urinary AGT during the initial 24 weeks as surrogate markers predicting the antiproteinuric effects of ARBs in patients with overt proteinuria.",2020,"Ln(uAGT/Cr) was an independent predictor for proteinuria decrement (OR 1.372, 95% CI, 1.068-1.762, P = 0.013).","['205 patients with overt proteinuria (urinary protein/creatinine ratio [uPCR]\u2009≥\u20091\u2009mg/mg) enrolled between April 2009 and December 2011', 'patients with overt proteinuria', 'Fifty-six patients were followed-up for 5\u2009years', 'The mean age was 47.6\u2009years and 51.2% were male']","['valsartan', 'angiotensin receptor blockers', 'angiotensin receptor blockers (ARBs']","['mean uPCR', 'urinary AGT/creatinine ratio (uAGT/Cr', 'proteinuria decrement', 'Natural logarithms (ln) (uAGT/Cr), ln(uR/Cr), and diabetes mellitus', 'renin/creatinine ratio (uR/Cr']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0428627', 'cui_str': 'Protein/creatinine ratio measurement'}, {'cui': 'C1319635', 'cui_str': 'mg/mg'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003017', 'cui_str': 'Angiotensinogen'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0002555', 'cui_str': 'Aminoglutethimide'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035094', 'cui_str': 'Renin'}]",205.0,0.0182478,"Ln(uAGT/Cr) was an independent predictor for proteinuria decrement (OR 1.372, 95% CI, 1.068-1.762, P = 0.013).","[{'ForeName': 'Junseok', 'Initials': 'J', 'LastName': 'Jeon', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Do Hee', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Medicine, Chungbuk National University Hospital, Cheongju, 28644, Republic of Korea.'}, {'ForeName': 'Hye Ryoun', 'Initials': 'HR', 'LastName': 'Jang', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea. shinehr@gmail.com.'}, {'ForeName': 'Jung Eun', 'Initials': 'JE', 'LastName': 'Lee', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Wooseong', 'Initials': 'W', 'LastName': 'Huh', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Hye-Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Medicine, Chungbuk National University Hospital, Cheongju, 28644, Republic of Korea.'}, {'ForeName': 'Dae Joong', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Yoon-Goo', 'Initials': 'YG', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}]",BMC nephrology,['10.1186/s12882-020-01825-6']
644,32072743,"Determination of HIV status and identification of incident HIV infections in a large, community-randomized trial: HPTN 071 (PopART).","INTRODUCTION
The HPTN 071 (PopART) trial evaluated the impact of an HIV combination prevention package that included ""universal testing and treatment"" on HIV incidence in 21 communities in Zambia and South Africa during 2013-2018. The primary study endpoint was based on the results of laboratory-based HIV testing for> 48,000 participants who were followed for up to three years. This report evaluated the performance of HIV assays and algorithms used to determine HIV status and identify incident HIV infections in HPTN 071, and assessed the impact of errors on HIV incidence estimates.
METHODS
HIV status was determined using a streamlined, algorithmic approach. A single HIV screening test was performed at centralized laboratories in Zambia and South Africa (all participants, all visits). Additional testing was performed at the HPTN Laboratory Center using antigen/antibody screening tests, a discriminatory test and an HIV RNA test. This testing was performed to investigate cases with discordant test results and confirm incident HIV infections.
RESULTS
HIV testing identified 978 seroconverter cases. This included 28 cases where the participant had acute HIV infection at the first HIV-positive visit. Investigations of cases with discordant test results identified cases where there was a participant or sample error (mixups). Seroreverter cases (errors where status changed from HIV infected to HIV uninfected, 0.4% of all cases) were excluded from the primary endpoint analysis. Statistical analysis demonstrated that exclusion of those cases improved the accuracy of HIV incidence estimates.
CONCLUSIONS
This report demonstrates that the streamlined, algorithmic approach effectively identified HIV infections in this large cluster-randomized trial. Longitudinal HIV testing (all participants, all visits) and quality control testing provided useful data on the frequency of errors and provided more accurate data for HIV incidence estimates.",2020,"Longitudinal HIV testing (all participants, all visits) and quality control testing provided useful data on the frequency of errors and provided more accurate data for HIV incidence estimates.","['21 communities in Zambia and South Africa during 2013-2018', '28 cases where the participant had acute HIV infection at the first HIV-positive visit']",[],['accuracy of HIV incidence estimates'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0343752', 'cui_str': 'Acute human immunodeficiency virus seroconversion illness'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}]",[],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",48000.0,0.0658167,"Longitudinal HIV testing (all participants, all visits) and quality control testing provided useful data on the frequency of errors and provided more accurate data for HIV incidence estimates.","[{'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Eshleman', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Piwowar-Manning', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Wilson', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Denni', 'Initials': 'D', 'LastName': 'Lennon', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Fogel', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Yaw', 'Initials': 'Y', 'LastName': 'Agyei', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Sullivan', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Weng', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Ayana', 'Initials': 'A', 'LastName': 'Moore', 'Affiliation': 'FHI360, Durham, NC, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Laeyendecker', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Kosloff', 'Affiliation': 'Zambart, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Bwalya', 'Affiliation': 'Zambart, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Maarman', 'Affiliation': 'Desmond Tutu TB Center, Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, Western Cape, South Africa.'}, {'ForeName': 'Anneen', 'Initials': 'A', 'LastName': 'van Deventer', 'Affiliation': 'Stellenbosch University, Stellenbosch, Western Cape, South Africa.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Floyd', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bock', 'Affiliation': 'Desmond Tutu TB Center, Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, Western Cape, South Africa.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'Zambart, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25452']
645,31704948,Statin Short-term Inhibition of Insulin Sensitivity and Secretion During Acute Phase of ST-Elevation Myocardial Infarction.,"Hyperglycemia during myocardial infarction (MI) has a strong and direct association with mortality. In stable patients and experimental models, statins favor the elevation of glycaemia. The present study investigated whether short-course treatment with statins during MI can influence glucose homeostasis and thus the clinical outcome. In this prospective study, euglycemic hyperinsulinemic clamp (EHC) was performed at second (D2) and sixth (D6) day after MI in patients randomized to simvastatin (S)10 or 80 mg/day during hospitalization (n = 27). In addition, patients (n = 550) were treated without (WS) or with simvastatin (S) at 20, 40 or 80 mg/day had HOMA2S on admission (D1) and fifth (D5) day after MI. According to EHC, insulin sensitivity increased by 20 ± 60% in S10 and decreased by -6 ± 28% in S80 (p = 0.025). Consistently, the changes in HOMA2S between D1 and D5 were 40 ± 145% (WS), 22 ± 117% (S20), 16 ± 61% (S40) and -2% ± 88% (S80) (p = 0.001). In conclusion, statin during the acute phase of MI reduces insulin sensitivity in a dose-dependent manner.",2019,"According to EHC, insulin sensitivity increased by 20 ± 60% in S10 and decreased by -6 ± 28% in S80 (p = 0.025).",[],"['simvastatin', 'euglycemic hyperinsulinemic clamp (EHC', 'simvastatin (S)10']","['insulin sensitivity', 'Hyperglycemia', 'Insulin Sensitivity and Secretion']",[],"[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}]",550.0,0.0261715,"According to EHC, insulin sensitivity increased by 20 ± 60% in S10 and decreased by -6 ± 28% in S80 (p = 0.025).","[{'ForeName': 'Andrei C', 'Initials': 'AC', 'LastName': 'Sposito', 'Affiliation': 'Faculty of Medical Sciences, State University of Campinas (Unicamp), Campinas, SP, Brazil. andreisposito@gmail.com.'}, {'ForeName': 'Luiz Sergio F', 'Initials': 'LSF', 'LastName': 'Carvalho', 'Affiliation': 'Faculty of Medical Sciences, State University of Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Filipe A', 'Initials': 'FA', 'LastName': 'Moura', 'Affiliation': 'Department of Medicine, Weill-Cornell Medical College, New York, New York, United States.'}, {'ForeName': 'Alessandra M', 'Initials': 'AM', 'LastName': 'Campos-Staffico', 'Affiliation': 'Faculty of Medical Sciences, State University of Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Riobaldo M R', 'Initials': 'RMR', 'LastName': 'Cintra', 'Affiliation': 'Faculty of Medical Sciences, State University of Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Nadruz', 'Affiliation': 'Faculty of Medical Sciences, State University of Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Osorio R', 'Initials': 'OR', 'LastName': 'Almeida', 'Affiliation': 'Hospital de Base do Distrito Federal, Brasília, Brazil.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Quinaglia E Silva', 'Affiliation': 'Hospital de Base do Distrito Federal, Brasília, Brazil.'}]",Scientific reports,['10.1038/s41598-019-52111-x']
646,31695168,Intrinsic connectomes are a predictive biomarker of remission in major depressive disorder.,"Although major depressive disorder (MDD) is associated with altered functional coupling between disparate neural networks, the degree to which such measures are ameliorated by antidepressant treatment is unclear. It is also unclear whether functional connectivity can be used as a predictive biomarker of treatment response. Here, we used whole-brain functional connectivity analysis to identify neural signatures of remission following antidepressant treatment, and to identify connectomic predictors of treatment response. 163 MDD and 62 healthy individuals underwent functional MRI during pre-treatment baseline and 8-week follow-up sessions. Patients were randomized to escitalopram, sertraline or venlafaxine-XR antidepressants and assessed at follow-up for remission. Baseline measures of intrinsic functional connectivity between each pair of 333 regions were analyzed to identify pre-treatment connectomic features that distinguish remitters from non-remitters. We then interrogated these connectomic differences to determine if they changed post-treatment, distinguished patients from controls, and were modulated by medication type. Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks. This baseline hypo-connectivity for non-remitters also distinguished them from controls and increased following treatment. In contrast, connectivity for remitters was higher than controls at baseline and also following remission, suggesting a trait-like connectomic characteristic. Increased functional connectivity within and between large-scale intrinsic brain networks may characterize acute recovery with antidepressants in depression.",2020,"Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks.",['163 MDD and 62 healthy individuals underwent'],"['escitalopram, sertraline or venlafaxine-XR antidepressants', 'functional MRI']","['connectivity for remitters', 'intrinsic functional connectivity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",163.0,0.0349942,"Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks.","[{'ForeName': 'Mayuresh S', 'Initials': 'MS', 'LastName': 'Korgaonkar', 'Affiliation': 'The Brain Dynamics Centre, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia. m.korgaonkar@sydney.edu.au.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fornito', 'Affiliation': 'Brain and Mental Health Research Hub, Turner Institute for Brain and Mental Health & Monash Biomedical Imaging, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'The Brain Dynamics Centre, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia. leawilliams@stanford.edu.'}]",Molecular psychiatry,['10.1038/s41380-019-0574-2']
647,31690740,Early evening light mitigates sleep compromising physiological and alerting responses to subsequent late evening light.,"The widespread use of electric light and electronic devices has resulted in an excessive exposure to light during the late-evening and at night. This late light exposure acutely suppresses melatonin and sleepiness and delays the circadian clock. Here we investigate whether the acute effects of late-evening light exposure on our physiology and sleepiness are reduced when this light exposure is preceded by early evening bright light. Twelve healthy young females were included in a randomised crossover study. All participants underwent three evening (18:30-00:30) sessions during which melatonin, subjective sleepiness, body temperature and skin blood flow were measured under different light conditions: (A) dim light, (B) dim light with a late-evening (22:30-23:30) light exposure of 750 lx, 4000 K, and (C) the same late-evening light exposure, but now preceded by early-evening bright light exposure (18.30-21.00; 1200 lx, 4000 K). Late-evening light exposure reduced melatonin levels and subjective sleepiness and resulted in larger skin temperature gradients as compared to dim. Interestingly, these effects were reduced when the late-evening light was preceded by an early evening 2.5-hour bright light exposure. Thus daytime and early-evening exposure to bright light can mitigate some of the sleep-disruptive consequences of light exposure in the later evening.",2019,Late-evening light exposure reduced melatonin levels and subjective sleepiness and resulted in larger skin temperature gradients as compared to dim.,['Twelve healthy young females'],['electric light and electronic devices'],"['melatonin levels and subjective sleepiness', 'subjective sleepiness, body temperature and skin blood flow', 'larger skin temperature gradients']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}]",12.0,0.029679,Late-evening light exposure reduced melatonin levels and subjective sleepiness and resulted in larger skin temperature gradients as compared to dim.,"[{'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Te Kulve', 'Affiliation': 'Department of Human Biology & Movement Sciences, NUTRIM, Maastricht University, Maastricht, The Netherlands. marijetekulve@gmail.com.'}, {'ForeName': 'Luc J M', 'Initials': 'LJM', 'LastName': 'Schlangen', 'Affiliation': 'Intelligent Lighting Institute, Department of Human Technology Interaction, Eindhoven University of Technology, Eindhoven, The Netherlands.'}, {'ForeName': 'Wouter D', 'Initials': 'WD', 'LastName': 'van Marken Lichtenbelt', 'Affiliation': 'Department of Human Biology & Movement Sciences, NUTRIM, Maastricht University, Maastricht, The Netherlands.'}]",Scientific reports,['10.1038/s41598-019-52352-w']
648,31554878,Concomitant screening of coronary artery disease and lung cancer with a new ultrafast-low-dose Computed Tomography protocol: A pilot randomised trial.,"We performed a pilot randomised study to assess the feasibility and radiation exposure of a new computed tomography (CT) protocol that allows screening of both coronary artery disease (CAD) and lung cancer. Current or former heavy smokers at high lung cancer risk with indication to cardiac CT for suspected or known CAD were randomised to undergo concomitant CT evaluation of either cardiac or thoracic area or cardiac CT only. Out of 129 subjects deemed eligible for the study, 110 agreed to participate and were randomised to simultaneous cardiac and lung CT (Gr.A; n = 55) or cardiac CT only (Gr.B; n = 55). The feasibility (i.e. adequate visualization of coronary artery segments) was noninferior with simultaneous cardiac and lung CT compared with the standard cardiac CT (870 of 889 segments [97%] in Gr.A vs 878/890 segments [99%] in Gr.B; mean difference 2.0% [90% confidence interval: -0.3% to 4.1%]). The safety (i.e. effective radiation dose) of the concomitant cardiac and lung CT protocol was noninferior to the standard cardiac CT (1.5 [95% confidence intervals: 1.2-1.7] vs. 1.4 [95% confidence intervals: 1.1-1.6] mSv; mean difference 0.1 mSv [90% confidence interval: -0.2 to 0.3 mSv]). In the two groups, a total of 25 significant (>70%) coronary stenoses were found at cardiac CT (9/55 cases of Gr.A vs 11/55 cases of Gr.B). Pulmonary nodules >2 mm were detected in 7 of the 55 Gr.A subjects. This pilot randomised study shows that concomitant CAD and lung cancer screening by means of a new CT protocol is both feasible and safe, thus allowing a comprehensive evaluation of both cardiac and thoracic regions during one CT scanning only. (ClinicalTrials.gov Identifier: NCT03727958).",2019,The safety (i.e. effective radiation dose) of the concomitant cardiac and lung CT protocol was noninferior to the standard cardiac CT (1.5 [95% confidence intervals: 1.2-1.7] vs. 1.4 [95% confidence intervals: 1.1-1.6] mSv; mean difference 0.1 mSv,"['129 subjects deemed eligible for the study, 110 agreed to participate and were randomised to simultaneous cardiac and lung CT (Gr', 'heavy smokers at high lung cancer risk with indication to cardiac CT for suspected or known CAD', 'coronary artery disease (CAD) and lung cancer']","['new ultrafast-low-dose Computed Tomography protocol', 'cardiac CT', 'standard cardiac CT', 'new computed tomography (CT) protocol', 'new CT protocol']",[],"[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0857118', 'cui_str': 'Heavy smoker'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0412618', 'cui_str': 'Cardiac CT'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0412618', 'cui_str': 'Cardiac CT'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0056574', 'cui_str': 'CT protocol'}]",[],889.0,0.0646978,The safety (i.e. effective radiation dose) of the concomitant cardiac and lung CT protocol was noninferior to the standard cardiac CT (1.5 [95% confidence intervals: 1.2-1.7] vs. 1.4 [95% confidence intervals: 1.1-1.6] mSv; mean difference 0.1 mSv,"[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Gaudio', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tanzilli', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Mariachiara', 'Initials': 'M', 'LastName': 'Mei', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moretti', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Barillà', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Varveri', 'Affiliation': 'Villa Mafalda Clinical Institute, Rome, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Paravati', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Tanzilli', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ciccaglioni', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Strano', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Pellegrini', 'Affiliation': 'Villa Mafalda Clinical Institute, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Barillari', 'Affiliation': 'Villa Mafalda Clinical Institute, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pelliccia', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy. f.pelliccia@mclink.it.'}]",Scientific reports,['10.1038/s41598-019-50407-6']
649,31025438,Effects of Targeted Versus Adjustable Protein Fortification of Breast Milk on Early Growth in Very Low-Birth-Weight Preterm Infants: A Randomized Clinical Trial.,"BACKGROUND
Breast milk is preferred for the feeding of very low-birth-weight (VLBW) infants, but it does not meet nutrition requirements unless it is fortified. Adequate protein intake to maintain the growth of preterm infants cannot be provided by standard fortification methods because of variation in the protein content of human milk. Individualization is necessary to achieve target protein intakes. The goal of this study was to compare the effects of 2 different methods of individualized protein fortification of breast milk on the early growth of VLBW preterm infants.
METHODS
In a prospective observational study, VLBW preterm infants ≤32 weeks of gestational age were randomized into 2 groups according to the method of breast milk fortification. Anthropometric measurements were performed in both groups weekly for 4 weeks to compare their growth.
RESULTS
During the trial period, the daily protein intake (targeted vs adjustable fortification groups) was (median [range]) 4.5 (4.4-4.6) vs 4.01 (3.5-4.4) g/kg/d (P = 0.001); the daily weight gains (g/d and g/kg/d; mean ± SD) were 25.7 ± 3.9 vs 22.2 ± 6.4 g/d (P = 0.048) and 23.1 ± 4.3 vs 18.7 ± 4.3 g/kg/d (P = 0.014); and the weekly increase in head circumference was 9.8 ± 1.5 vs 8.4 ± 2.1 mm/wk (P = 0.040). All parameters were significantly higher in the targeted than the adjustable fortification group.
CONCLUSIONS
Individualized protein fortification using the targeted method for VLBW preterm infants had more positive effects on short-term growth compared with the adjustable fortification method.",2020,g/kg/d (P = 0.001); the daily weight gains (g/d and g/kg/d; mean ± SD) were 25.7 ± 3.9 vs 22.2 ± 6.4 g/d (P = 0.048) and 23.1 ± 4.3 vs 18.7 ± ,"['VLBW preterm infants', 'VLBW preterm infants ≤32\xa0weeks of gestational age', 'Very Low-Birth-Weight Preterm Infants']","['Targeted Versus Adjustable Protein Fortification of Breast Milk', 'individualized protein fortification of breast milk', 'breast milk fortification']","['head circumference', 'daily weight gains']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}]","[{'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",,0.0517995,g/kg/d (P = 0.001); the daily weight gains (g/d and g/kg/d; mean ± SD) were 25.7 ± 3.9 vs 22.2 ± 6.4 g/d (P = 0.048) and 23.1 ± 4.3 vs 18.7 ± ,"[{'ForeName': 'Ozgul', 'Initials': 'O', 'LastName': 'Bulut', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Istanbul University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Asuman', 'Initials': 'A', 'LastName': 'Coban', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Istanbul University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Ozan', 'Initials': 'O', 'LastName': 'Uzunhan', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Istanbul University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Ince', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Istanbul University Faculty of Medicine, Istanbul, Turkey.'}]",Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition,['10.1002/ncp.10307']
650,31009408,"Effects of an Intensive Discharge Intervention on Medication Adherence, Glycemic Control, and Readmission Rates in Patients With Type 2 Diabetes.","OBJECTIVES
Patients with diabetes are at particularly high risk for adverse outcomes after hospitalization. The goals of this study were to design, implement, and evaluate a multipronged transitional care intervention among hospitalized patients with diabetes.
METHODS
We randomly assigned inpatients likely to be discharged home on insulin to an intensive transitional care intervention or usual care. The primary outcome was 90-day postdischarge insulin adherence, using prescription refill information to calculate a medication possession ratio. Unadjusted analyses were conducted using Wilcoxon rank sum, adjusted analyses using multivariable linear regression, and weighted propensity scoring methods with general estimating equations accounted for clustering by admitting physician.
RESULTS
One hundred eighty patients participated. The mean (SD) medication possession ratio to all insulin types was 84.5% (22.6) among intervention and 76.4% (25.1) usual care patients (difference = 8.1, 95% confidence interval = -1.0 to 17.2, P = 0.06), with a smaller difference for adherence to all medications (86.3% versus 82.0%). A1c levels decreased in both groups but was larger in the intervention arm (1.09 and 0.11, respectively) (difference = -0.98, 95% confidence interval = -2.03 to -0.07, P = 0.04). Differences between study arms were not significant for rates of hypoglycemic episodes, 30-day readmissions, or emergency department visits. In adjusted/clustered analyses, the difference in A1c reduction remained statistically significant, whereas differences in all other outcomes remained nonsignificant.
CONCLUSIONS
The intervention was associated with improvements in glycemic control, with nonsignificant trends toward greater medication adherence. Further research is needed to optimize and successfully implement interventions to improve patient safety and health outcomes during care transitions.",2019,"Differences between study arms were not significant for rates of hypoglycemic episodes, 30-day readmissions, or emergency department visits.","['We randomly assigned inpatients likely to be discharged home on insulin to an intensive transitional care intervention or usual care', 'Patients with diabetes', 'One hundred eighty patients participated', 'Patients With Type 2 Diabetes', 'hospitalized patients with diabetes']","['multipronged transitional care intervention', 'Intensive Discharge Intervention']","['90-day postdischarge insulin adherence, using prescription refill information to calculate a medication possession ratio', 'medication adherence', 'A1c levels', 'Medication Adherence, Glycemic Control, and Readmission Rates', 'glycemic control', 'mean (SD) medication possession ratio to all insulin types', 'rates of hypoglycemic episodes, 30-day readmissions, or emergency department visits']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycemic attack'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]",180.0,0.103197,"Differences between study arms were not significant for rates of hypoglycemic episodes, 30-day readmissions, or emergency department visits.","[{'ForeName': 'Cherlie', 'Initials': 'C', 'LastName': 'Magny-Normilus', 'Affiliation': ''}, {'ForeName': 'Nyryan V', 'Initials': 'NV', 'LastName': 'Nolido', 'Affiliation': ''}, {'ForeName': 'Jorge C', 'Initials': 'JC', 'LastName': 'Borges', 'Affiliation': ''}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Brady', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Labonville', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Soukup', 'Affiliation': ''}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Lipsitz', 'Affiliation': ''}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Hudson', 'Affiliation': ''}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Schnipper', 'Affiliation': ''}]",Journal of patient safety,['10.1097/PTS.0000000000000601']
651,31699072,Nebulized hypertonic saline 3% for 1 versus 3 days in hospitalized bronchiolitis: a blinded non-inferiority randomized controlled trial.,"BACKGROUND
The use and optimal duration of treatment with nebulized hypertonic saline (HS) in infants hospitalized for acute bronchiolitis is unclear. The objective was to compare the efficacy of 1 versus 3 days of nebulized 3% HS at 72 h of treatment. We conducted a blinded non-inferiority randomized controlled trial including infants aged less than 12 months old, hospitalized for a moderate bronchiolitis.
METHODS
Nebulisations of 3% HS for 1 day were followed by either the continuation of 3% HS (HS3d group) or switched to 0.9% normal isotonic saline (HS1d group) for 2 days Randomization was performed according to a predefined list with a 1:1 ratio, obtained with a random generator number with blocks.. Main outcome was mean Wang clinical severity score (CSS) after 72 h of treatment.
RESULTS
One hundred sixteen infants (HS1d n = 59 and HS3d n = 57), were included over two epidemic seasons from 2014 to 2016, but recruitement did not reach the planned sample size. The difference for the Wang CSS score in the HS3d vs HS1d group was 0.71 [IC 90% 0.1; 1.3], above the precluded value of 0.4 set in the protocol defining the non-inferiority of shorter treatment duration. Clinical remission was more rapidly obtained in the HS3d than in HS1d (2.3 ± 1.6 vs 2.9 ± 1.4 days, p = 0.04), with a non-significant tendency for less need of nutritional support and supplemental oxygen in HS3d group. Clinical worsening and treatment intolerance were similar in the 2 groups.
CONCLUSIONS
Despite being underpowered, results seem not to be in favour of reducing the duration of nebulised HS treatment from 3 to 1 day in acute moderate bronchiolitis.
TRIAL REGISTRATION
Clinical trials NCT02538458, October 2014.",2019,"Despite being underpowered, results seem not to be in favour of reducing the duration of nebulised HS treatment from 3 to 1 day in acute moderate bronchiolitis.
","['One hundred sixteen infants (HS1d n\u2009=\u200959 and HS3d n\u2009=\u200957', 'infants hospitalized for acute bronchiolitis', 'Nebulisations of 3', 'hospitalized bronchiolitis', 'infants aged less than 12\u2009months old, hospitalized for a moderate bronchiolitis']","['nebulized hypertonic saline (HS', 'HS (HS3d group) or switched to 0.9% normal isotonic saline (HS1d', 'Nebulized hypertonic saline']","['Clinical worsening and treatment intolerance', 'mean Wang clinical severity score (CSS', 'CSS score', 'Clinical remission']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001311', 'cui_str': 'Acute capillary bronchiolitis'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439166', 'cui_str': '% normal (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",116.0,0.404323,"Despite being underpowered, results seem not to be in favour of reducing the duration of nebulised HS treatment from 3 to 1 day in acute moderate bronchiolitis.
","[{'ForeName': 'Gaëlle', 'Initials': 'G', 'LastName': 'Beal', 'Affiliation': 'Department of Pediatrics, Centre Hospitalier Métropole Savoie, FR-73000, Chambéry, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Barbier', 'Affiliation': 'Department of Pediatrics, Centre Hospitalier Universitaire Grenoble Alpes, FR-38000, Grenoble, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Thoret', 'Affiliation': 'CIC U1406, INSERM, FR-38000, Grenoble, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Rubio', 'Affiliation': 'Department of Pediatrics, Centre Hospitalier Universitaire Grenoble Alpes, FR-38000, Grenoble, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Bonnet', 'Affiliation': 'Department of Pediatrics, Centre Hospitalier Universitaire Grenoble Alpes, FR-38000, Grenoble, France.'}, {'ForeName': 'Roseline', 'Initials': 'R', 'LastName': 'Mazet', 'Affiliation': 'Department of Pharmacy, CHU Grenoble Alpes, FR-38000, Grenoble, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ego', 'Affiliation': 'CIC U1406, INSERM, FR-38000, Grenoble, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Pin', 'Affiliation': 'Department of Pediatrics, Centre Hospitalier Universitaire Grenoble Alpes, FR-38000, Grenoble, France. ipin@chu-grenoble.fr.'}]",BMC pediatrics,['10.1186/s12887-019-1804-0']
652,31685853,An Exploratory Study of Predictors of Response to Vagus Nerve Stimulation Paired with Upper-Limb Rehabilitation After Ischemic Stroke.,"We have previously shown the safety and feasibility of vagus nerve stimulation (VNS) paired with upper-limb rehabilitation after ischemic stroke. In this exploratory study, we assessed whether clinical and brain MRI variables predict response to treatment. We used data from two completed randomised and blinded clinical trials (N = 35). All participants had moderate to severe upper-limb weakness and were randomised to 6-weeks intensive physiotherapy with or without VNS. Participants had 3 T brain MRI at baseline. The primary outcome was change in Fugl-Meyer Assessment, upper-extremity score (FMA-UE) from baseline to the first day after therapy completion. We used general linear regression to identify clinical and brain MRI predictors of change in FMA-UE. VNS-treated participants had greater improvement in FMA-UE at day-1 post therapy than controls (8.63 ± 5.02 versus 3.79 ± 5.04 points, t = 2.83, Cohen's d = 0.96, P = 0.008). Higher cerebrospinal fluid volume was associated with less improvement in FMA-UE in the control but not VNS group. This was also true for white matter hyperintensity volume but not after removal of an outlying participant from the control group. Responders in the VNS group had more severe arm impairment at baseline than responders to control. A phase III trial is now underway to formally determine whether VNS improves outcomes and will explore whether these differ in people with more severe baseline upper-limb disability and cerebrovascular disease.",2019,This was also true for white matter hyperintensity volume but not after removal of an outlying participant from the control group.,['All participants had moderate to severe upper-limb weakness'],"['VNS', 'vagus nerve stimulation (VNS) paired with upper-limb rehabilitation', 'Vagus Nerve Stimulation Paired with Upper-Limb Rehabilitation', '6-weeks intensive physiotherapy with or without VNS']","['FMA-UE', 'severe arm impairment', 'Higher cerebrospinal fluid volume', 'change in Fugl-Meyer Assessment, upper-extremity score (FMA-UE']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3714552', 'cui_str': 'Weakness - general'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3888791', 'cui_str': 'Cerebrospinal fluid volume'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.277045,This was also true for white matter hyperintensity volume but not after removal of an outlying participant from the control group.,"[{'ForeName': 'David Alexander', 'Initials': 'DA', 'LastName': 'Dickie', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary & Life Sciences, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, G51 4TF, United Kingdom. david.dickie@glasgow.ac.uk.'}, {'ForeName': 'Teresa Jacobson', 'Initials': 'TJ', 'LastName': 'Kimberley', 'Affiliation': 'School of Health and Rehabilitation Sciences, MGH Institute of Health Professions, Charlestown Navy Yard, 36 1st Avenue, Boston, MA, 02129, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pierce', 'Affiliation': 'MicroTransponder, Inc., Austin, TX, United States.'}, {'ForeName': 'Navzer', 'Initials': 'N', 'LastName': 'Engineer', 'Affiliation': 'MicroTransponder, Inc., Austin, TX, United States.'}, {'ForeName': 'W Brent', 'Initials': 'WB', 'LastName': 'Tarver', 'Affiliation': 'MicroTransponder, Inc., Austin, TX, United States.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Dawson', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary & Life Sciences, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, G51 4TF, United Kingdom.'}]",Scientific reports,['10.1038/s41598-019-52092-x']
653,31685913,Effects of modified aerobic training on muscle metabolism in individuals with peripheral arterial disease: a randomized clinical trial.,"The primary objective of this study was to compare the effects on muscle metabolism of two types of aerobic training, with and without a load on the lower limbs, in adults with peripheral arterial disease (PAD). A simple blind randomized clinical trial was conducted using two groups: conventional aerobic (CG) and modified aerobic with a load on the lower limbs (MG). Both groups underwent training by walking three times a week over a 12-week period. The ratings of muscle metabolism were determined after a treadmill test with constant velocity and inclination concomitant with the use of near infrared spectroscopy (NIRS). Altogether 40 individuals with PAD (CG = 65.45 ± 10.60 and MG = 63.10 ± 10.54) were included in the study. After the intervention, in both groups, there was a reduction in the relative time to recovery (p = 0.002), an improvement in the re-oxygenation rate (p = 0.017), an increased time of resistance after reaching the lowest muscle oxygen saturation (StO 2 ) (p < 0.001), an increase in the distance walked (p < 0.001), and an improvement of the walking economy relative to StO 2 (p < 0.001). After 12 weeks of training, an improvement in the deoxygenation rate was observed in both groups (p = 0.002), but with a greater magnitude in the CG (p = 0.017). Only the CG presented an increase in time to reach the lowest StO 2 on the treadmill after the intervention (p = 0.010). The traditional aerobic training was superior to the modified training in relation to the improvement of muscle metabolism in patients with PAD.",2019,"After 12 weeks of training, an improvement in the deoxygenation rate was observed in both groups (p = 0.002), but with a greater magnitude in the CG (p = 0.017).","['adults with peripheral arterial disease (PAD', 'individuals with peripheral arterial disease', 'Altogether 40 individuals with PAD (CG\u2009=\u200965.45\u2009±\u200910.60 and MG\u2009=\u200963.10\u2009±\u200910.54) were included in the study', 'patients with PAD']","['traditional aerobic training', 'modified aerobic training', 'aerobic training', 'conventional aerobic (CG) and modified aerobic with a load on the lower limbs (MG']","['muscle metabolism', 're-oxygenation rate', 'relative time to recovery', 'time of resistance after reaching the lowest muscle oxygen saturation', 'deoxygenation rate', 'time to reach the lowest StO', 'ratings of muscle metabolism', 'distance walked']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0439564', 'cui_str': 'Relative time'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",40.0,0.0565781,"After 12 weeks of training, an improvement in the deoxygenation rate was observed in both groups (p = 0.002), but with a greater magnitude in the CG (p = 0.017).","[{'ForeName': 'Débora Pantuso', 'Initials': 'DP', 'LastName': 'Monteiro', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Avenida Presidente Antônio Carlos, 6627 - Pampulha, Belo Horizonte, MG, CEP 31270-901, Brazil.'}, {'ForeName': 'Giane Amorim', 'Initials': 'GA', 'LastName': 'Ribeiro-Samora', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Avenida Presidente Antônio Carlos, 6627 - Pampulha, Belo Horizonte, MG, CEP 31270-901, Brazil.'}, {'ForeName': 'Raquel Rodrigues', 'Initials': 'RR', 'LastName': 'Britto', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Avenida Presidente Antônio Carlos, 6627 - Pampulha, Belo Horizonte, MG, CEP 31270-901, Brazil.'}, {'ForeName': 'Danielle Aparecida Gomes', 'Initials': 'DAG', 'LastName': 'Pereira', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Avenida Presidente Antônio Carlos, 6627 - Pampulha, Belo Horizonte, MG, CEP 31270-901, Brazil. danielleufmg@gmail.com.'}]",Scientific reports,['10.1038/s41598-019-52428-7']
654,30997730,"Effect of high polyphenol extra virgin olive oil on markers of cardiovascular disease risk in healthy Australian adults (OLIVAUS): A protocol for a double-blind randomised, controlled, cross-over study.","BACKGROUND
Previous clinical studies have suggested that high polyphenol extra virgin olive oil (EVOO) provides a superior cardioprotective effect compared to low polyphenol olive oil. However, further studies are required to replicate these results in non-Mediterranean populations.
AIM
To investigate the effect of high polyphenol EVOO versus low polyphenol olive oil with known polyphenol composition on markers of cardiovascular disease risk in a healthy non-Mediterranean cohort.
METHODS
In a double-blind randomised cross-over trial, the present study will examine the effect of high polyphenol EVOO versus low polyphenol olive oil in 50 healthy participants. Each intervention phase will be 3 weeks long with a 2-week washout period between each phase. Outcomes to be assessed include HDL cholesterol efflux, oxidised LDL, blood lipids, C-reactive protein, arterial stiffness, blood pressure and cognitive function. Dietary intake, physical activity levels and anthropometry will also be collected.
DISCUSSION
Because of the rigorous trial design, novel and clinically relevant outcomes, the use of a well-characterised EVOO, and, in contrast to the current literature, the non-Mediterranean study population, the present study will provide a significant contribution to the understanding of the clinical importance of polyphenol intake in the Australian sociocultural context.",2020,"Outcomes to be assessed include HDL cholesterol efflux, oxidised LDL, blood lipids, C-reactive protein, arterial stiffness, blood pressure and cognitive function.","['50 healthy participants', 'healthy Australian adults (OLIVAUS', 'healthy non-Mediterranean cohort']","['high polyphenol extra virgin olive oil', 'polyphenol EVOO versus low polyphenol olive oil', 'polyphenol extra virgin olive oil (EVOO', 'high polyphenol EVOO versus low polyphenol olive oil with known polyphenol composition']","['cardiovascular disease risk', 'Dietary intake, physical activity levels and anthropometry', 'HDL cholesterol efflux, oxidised LDL, blood lipids, C-reactive protein, arterial stiffness, blood pressure and cognitive function']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C3539166', 'cui_str': 'Oxidised LDL'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",50.0,0.194891,"Outcomes to be assessed include HDL cholesterol efflux, oxidised LDL, blood lipids, C-reactive protein, arterial stiffness, blood pressure and cognitive function.","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Marx', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, College of Science, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elena S', 'Initials': 'ES', 'LastName': 'George', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, College of Science, Melbourne, Victoria, Australia.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Mayr', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, College of Science, Melbourne, Victoria, Australia.'}, {'ForeName': 'Colleen J', 'Initials': 'CJ', 'LastName': 'Thomas', 'Affiliation': 'Department of Physiology, Anatomy and Microbiology, School of Life Sciences, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Sarapis', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, College of Science, Melbourne, Victoria, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Moschonis', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, College of Science, Melbourne, Victoria, Australia.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Kennedy', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pipingas', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Willcox', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, College of Science, Melbourne, Victoria, Australia.'}, {'ForeName': 'Luke A', 'Initials': 'LA', 'LastName': 'Prendergast', 'Affiliation': 'Department of Mathematics and Statistics, School of Engineering and Mathematical Sciences, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Itsiopoulos', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, College of Science, Melbourne, Victoria, Australia.'}]",Nutrition & dietetics: the journal of the Dietitians Association of Australia,['10.1111/1747-0080.12531']
655,31690824,Fear expression is suppressed by tyrosine administration.,"Animal studies have demonstrated that catecholamines regulate several aspects of fear conditioning. In humans, however, pharmacological manipulations of the catecholaminergic system have been scarce, and their primary focus has been to interfering with catecholaminergic activity after fear acquisition or expression had taken place, using L-Dopa, primarily, as catecholaminergic precursor. Here, we sought to determine if putative increases in presynaptic dopamine and norepinephrine by tyrosine administered before conditioning could affect fear expression. Electrodermal activity (EDA) of 46 healthy participants (24 placebo, 22 tyrosine) was measured in an instructed fear task. Results showed that tyrosine abolished fear expression compared to placebo. Importantly, tyrosine did not affect EDA responses to the aversive stimulus (UCS) or alter participants' mood. Therefore, the effect of tyrosine on fear expression cannot be attributed to these factors. Taken together, these findings provide evidence that the catecholaminergic system influences fear expression in humans.",2019,"Importantly, tyrosine did not affect EDA responses to the aversive stimulus (UCS) or alter participants' mood.","['46 healthy participants (24 placebo, 22 tyrosine) was measured in\xa0an instructed fear task']",['placebo'],"['Electrodermal activity (EDA', 'Fear expression', 'fear expression']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",46.0,0.0189243,"Importantly, tyrosine did not affect EDA responses to the aversive stimulus (UCS) or alter participants' mood.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Soranzo', 'Affiliation': 'Department of Psychology, Sociology and Politics, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Aquili', 'Affiliation': 'Department of Psychology, Sociology and Politics, Sheffield Hallam University, Sheffield, UK. luca.aquili@shu.ac.uk.'}]",Scientific reports,['10.1038/s41598-019-52610-x']
656,29281192,Dried salted plum consumption ameliorates hyperbaric oxygen therapy-induced otalgia severity at the first chamber session: a prospective randomized controlled study.,"PURPOSE
One of the most common complications of hyperbaric oxygen (HBO₂) therapy is middle ear barotrauma (MEB), occasionally causing otalgia. The objective of this study was to evaluate the effect of dried salted plum consumption on MEB and otalgia associated with HBO₂ therapy.
MATERIALS AND METHODS
Patients undergoing the first chamber session of HBO₂ therapy were included in the present prospective randomized controlled trial. The Valsalva maneuver was administered to all patients before HBO₂. The patients were randomly divided into two groups: one that ate a dried salted plum during HBO₂ treatment and the other that did not. An otoscopic examination was performed after HBO₂ therapy. The MEB was graded according to Teed scores. The degree of otalgia was recorded using the Visual Analog Scale (VAS).
RESULTS
Ninety patients were enrolled. The overall incidence of MEB (Teed score grade 1~4) was 39.6% (21 of 53) for patients administered a dried salted plum versus 37.8% (14 of 37) for the control group (P=1.000). The incidence of mild MEB (Teed score grade 1~2) and severe MEB (Teed score Grade 3~4) between the two groups was not significantly different. Otalgia was present in 5.7% (3 of 53) of patients administered a dried salted plum versus 18.9% (7 of 37) for the control group (P=.085). No patients administered a dried salted plum had a VAS score ≥4 for otalgia versus 10.8% (4 of 37) for the control group (P=.026).
CONCLUSIONS
Dried salted plum consumption does not decrease the incidence of MEB, but may ameliorate the severity of first chamber session HBO₂-induced otalgia.",2017,Otalgia was present in 5.7% (3 of 53) of patients administered a dried salted plum versus 18.9% (7 of 37) for the control group (P=.085).,"['Ninety patients were enrolled', 'Patients undergoing the first chamber session of HBO₂ therapy']","['HBO₂) therapy', 'Dried salted plum consumption ameliorates hyperbaric oxygen therapy', 'dried salted plum consumption', 'hyperbaric oxygen']","['Otalgia', 'overall incidence of MEB', 'degree of otalgia', 'incidence of mild MEB (Teed score grade 1~2) and severe MEB', 'VAS score ≥4 for otalgia', 'incidence of MEB', 'Visual Analog Scale (VAS']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0936040', 'cui_str': 'Plum'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric Oxygen Therapy'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0013456', 'cui_str': 'Otalgia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",90.0,0.0364119,Otalgia was present in 5.7% (3 of 53) of patients administered a dried salted plum versus 18.9% (7 of 37) for the control group (P=.085).,"[{'ForeName': 'Fan-Chun', 'Initials': 'FC', 'LastName': 'Meng', 'Affiliation': 'Hyperbaric Oxygen Therapy Center, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Chih-Hao', 'Initials': 'CH', 'LastName': 'Shen', 'Affiliation': 'Hyperbaric Oxygen Therapy Center, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Chi-Ming', 'Initials': 'CM', 'LastName': 'Chu', 'Affiliation': 'Department of Epidemiology, School of Public Health, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ping', 'Initials': 'CP', 'LastName': 'Shih', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Hung-Che', 'Initials': 'HC', 'LastName': 'Lin', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Chung-Kan', 'Initials': 'CK', 'LastName': 'Peng', 'Affiliation': 'Hyperbaric Oxygen Therapy Center, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Shun Cheng', 'Initials': 'SC', 'LastName': 'Chang', 'Affiliation': 'Division of Plastic Surgery, Department of Surgery, Hyperbaric Oxygen Therapy Center, Shuang-Ho Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Kun-Lun', 'Initials': 'KL', 'LastName': 'Huang', 'Affiliation': 'Hyperbaric Oxygen Therapy Center, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}]","Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical Society, Inc",[]
657,31005993,Prediction of the effect of dapagliflozin on kidney and heart failure outcomes based on short-term changes in multiple risk markers.,"BACKGROUND
Besides improving glucose control, sodium-glucose co-transporter 2 inhibition with dapagliflozin reduces blood pressure, body weight and urinary albumin:creatinine ratio (UACR) in patients with type 2 diabetes (T2DM). The parameter response efficacy (PRE) score was developed to predict how short-term drug effects on cardiovascular risk markers translate into long-term changes in clinical outcomes. We applied the PRE score to clinical trials of dapagliflozin to model the effect of the drug on kidney and heart failure (HF) outcomes in patients with T2DM and impaired kidney function.
METHODS
The relationships between multiple risk markers and long-term outcome were determined in a background population of patients with T2DM with a multivariable Cox model. These relationships were then applied to short-term changes in risk markers observed in a pooled database of dapagliflozin trials (n = 7) that recruited patients with albuminuria to predict the drug-induced changes to kidney and HF outcomes.
RESULTS
A total of 132 and 350 patients had UACR >200 mg/g and >30 mg/g at baseline, respectively, and were selected for analysis. The PRE score predicted a risk change for kidney events of -40.8% [95% confidence interval (CI) -51.7 to -29.4) and -40.4% (95% CI -48.4 to -31.1) with dapagliflozin 10 mg compared with placebo for the UACR >200 mg/g and >30 mg/g subgroups. The predicted change in risk for HF events was -27.3% (95% CI -47.7 to -5.1) and -21.2% (95% CI -35.0 to -7.8), respectively. Simulation analyses showed that even with a smaller albuminuria-lowering effect of dapagliflozin (10% instead of the observed 35% in both groups), the estimated kidney risk reduction was still 26.5 and 26.8%, respectively.
CONCLUSIONS
The PRE score predicted clinically meaningful reductions in kidney and HF events associated with dapagliflozin therapy in patients with diabetic kidney disease. These results support a large long-term outcome trial in this population to confirm the benefits of the drug on these endpoints.",2020,The PRE score predicted a risk change for kidney events of -40.8% [95% confidence interval (CI) -51.7 to -29.4) and -40.4% (95% CI -48.4 to -31.1) with dapagliflozin 10 mg compared with placebo for the UACR >200 mg/g and >30 ,"['patients with type 2 diabetes (T2DM', 'A total of 132 and 350 patients had UACR\u2009>200\u2009mg/g and >30\u2009mg/g at baseline, respectively, and were selected for analysis', 'patients with T2DM and impaired kidney function', 'patients with diabetic kidney disease']","['dapagliflozin therapy', 'placebo', 'dapagliflozin']","['parameter response efficacy (PRE) score', 'multiple risk markers', 'blood pressure, body weight and urinary albumin:creatinine ratio (UACR', 'risk for HF events', 'kidney risk reduction', 'kidney and heart failure (HF) outcomes', 'PRE score predicted a risk change for kidney events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0689993,The PRE score predicted a risk change for kidney events of -40.8% [95% confidence interval (CI) -51.7 to -29.4) and -40.4% (95% CI -48.4 to -31.1) with dapagliflozin 10 mg compared with placebo for the UACR >200 mg/g and >30 ,"[{'ForeName': 'Nienke M A', 'Initials': 'NMA', 'LastName': 'Idzerda', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefansson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Pena', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Sjostrom', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'Department of Renal Medicine, University College London, London, UK.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz064']
658,29040609,Improving patient safety and efficiency of medication reconciliation through the development and adoption of a computer-assisted tool with automated electronic integration of population-based community drug data: the RightRx project.,"Background and Objective
Many countries require hospitals to implement medication reconciliation for accreditation, but the process is resource-intensive, thus adherence is poor. We report on the impact of prepopulating and aligning community and hospital drug lists with data from population-based and hospital-based drug information systems to reduce workload and enhance adoption and use of an e-medication reconciliation application, RightRx.
Methods
The prototype e-medical reconciliation web-based software was developed for a cluster-randomized trial at the McGill University Health Centre. User-centered design and agile development processes were used to develop features intended to enhance adoption, safety, and efficiency. RightRx was implemented in medical and surgical wards, with support and training provided by unit champions and field staff. The time spent per professional using RightRx was measured, as well as the medication reconciliation completion rates in the intervention and control units during the first 20 months of the trial.
Results
Users identified required modifications to the application, including the need for dose-based prescribing, the role of the discharge physician in prescribing community-based medication, and access to the rationale for medication decisions made during hospitalization. In the intervention units, both physicians and pharmacists were involved in discharge reconciliation, for 96.1% and 71.9% of patients, respectively. Medication reconciliation was completed for 80.7% (surgery) to 96.0% (medicine) of patients in the intervention units, and 0.7% (surgery) to 82.7% of patients in the control units. The odds of completing medication reconciliation were 9 times greater in the intervention compared to control units (odds ratio: 9.0, 95% confidence interval, 7.4-10.9, P < .0001) after adjusting for differences in patient characteristics.
Conclusion
High rates of medication reconciliation completion were achieved with automated prepopulation and alignment of community and hospital medication lists.",2018,"Medication reconciliation was completed for 80.7% (surgery) to 96.0% (medicine) of patients in the intervention units, and 0.7% (surgery) to 82.7% of patients in the control units.",[],['RightRx'],"['Medication reconciliation', 'time spent per professional using RightRx', 'odds of completing medication reconciliation']",[],[],"[{'cui': 'C2317067', 'cui_str': 'Medication Reconciliation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.0393805,"Medication reconciliation was completed for 80.7% (surgery) to 96.0% (medicine) of patients in the intervention units, and 0.7% (surgery) to 82.7% of patients in the control units.","[{'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Tamblyn', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montréal, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Winslade', 'Affiliation': 'Department of Medicine, McGill University, Montréal, Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, McGill University, Montréal, Canada.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Motulsky', 'Affiliation': 'Department of Medicine, McGill University, Montréal, Canada.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Meguerditchian', 'Affiliation': 'Department of Medicine, McGill University, Montréal, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Bustillo', 'Affiliation': 'Clinical and Health Informatics Research Group, McGill University, Montréal, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Elsayed', 'Affiliation': 'Clinical and Health Informatics Research Group, McGill University, Montréal, Canada.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Buckeridge', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montréal, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Couture', 'Affiliation': 'McGill University Health Centre, Montréal, Canada.'}, {'ForeName': 'Christina J', 'Initials': 'CJ', 'LastName': 'Qian', 'Affiliation': 'Clinical and Health Informatics Research Group, McGill University, Montréal, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Moraga', 'Affiliation': 'Clinical and Health Informatics Research Group, McGill University, Montréal, Canada.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Huang', 'Affiliation': 'Division of Geriatric Medicine, University of Ottawa, Ottawa, Canada.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocx107']
659,31008744,Use of Silver-Containing Hydrofiber and Chlorhexidine-Impregnated Tulle Gras Dressings for Second-Degree Burns.,"OBJECTIVE
This study evaluated the use of silver-containing hydrofiber and chlorhexidine-impregnated tulle gras dressings for second-degree burns.
METHODS
This randomized clinical study consisted of 60 patients with second-degree burns. Data were collected using a Patient Identification Form, Wound Assessment Form, and Pain Assessment Scale. Following dressing application, wounds were assessed on days 7, 15, and 22. Study procedures were continued until full epithelialization occurred.
RESULTS
After the seventh day of follow-up, significant improvement was noted in the experimental group in terms of wound exudate, wound debridement, pain intensity, and analgesic agent administration. After the 15th day of follow-up, there was a significant decrease in epithelialization time in the experimental group. Exudate control was better in patients whose burns were treated with silver-containing hydrofiber dressings, and they needed less debridement and fewer analgesics because of infrequent dressing changes. Lower pain scores were reported, the burn area reduced more quickly, and faster epithelialization and wound healing were achieved.
CONCLUSIONS
The authors conclude that silver-containing hydrofiber dressings are an effective wound care material that improve the wound healing process. More studies comparing it and other wound care materials could improve the quality of healthcare for patients with burns.",2019,"After the seventh day of follow-up, significant improvement was noted in the experimental group in terms of wound exudate, wound debridement, pain intensity, and analgesic agent administration.","['Second-Degree Burns', 'patients with burns', '60 patients with second-degree burns']","['silver-containing hydrofiber dressings', 'silver-containing hydrofiber and chlorhexidine-impregnated tulle gras dressings', 'Silver-Containing Hydrofiber and Chlorhexidine-Impregnated Tulle Gras Dressings']","['Lower pain scores', 'epithelialization and wound healing', 'wound exudate, wound debridement, pain intensity, and analgesic agent administration', 'epithelialization time', 'quality of healthcare', 'Patient Identification Form, Wound Assessment Form, and Pain Assessment Scale']","[{'cui': 'C0332687', 'cui_str': 'Second degree burn injury (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006434', 'cui_str': 'Burns'}]","[{'cui': 'C0037125', 'cui_str': 'Silver'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization (morphologic abnormality)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0015388', 'cui_str': 'Exudate'}, {'cui': 'C0191342', 'cui_str': 'Debridement of wound of skin (procedure)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0558033', 'cui_str': 'Wound assessment'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C0222045'}]",60.0,0.0245638,"After the seventh day of follow-up, significant improvement was noted in the experimental group in terms of wound exudate, wound debridement, pain intensity, and analgesic agent administration.","[{'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Pamuk Cebeci', 'Affiliation': 'Sevil Pamuk Cebeci, PhD, is a Nurse, Yunus Emre Public Hospital, Eskisehir, Turkey. Rengin Acaroğlu, Prof Dr, is a Professor, Florence Nightingale Nursing Faculty, Istanbul University Health Sciences Institute, Istanbul, Turkey. The authors have disclosed no financial relationships related to this article. Submitted June 12, 2018; accepted in revised form July 23, 2018; published online ahead of print April 2, 2019.'}, {'ForeName': 'Rengin', 'Initials': 'R', 'LastName': 'Acaroğlu', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000553598.12820.e7']
660,30975539,Smoking cessation for people with severe mental illness (SCIMITAR+): a pragmatic randomised controlled trial.,"BACKGROUND
People with severe mental illnesses such as schizophrenia are three times more likely to smoke than the wider population, contributing to widening health inequalities. Smoking remains the largest modifiable risk factor for this health inequality, but people with severe mental illness have not historically engaged with smoking cessation services. We aimed to test the effectiveness of a combined behavioural and pharmacological smoking cessation intervention targeted specifically at people with severe mental illness.
METHODS
In the smoking cessation intervention for severe mental illness (SCIMITAR+) trial, a pragmatic, randomised controlled study, we recruited heavy smokers with bipolar disorder or schizophrenia from 16 primary care and 21 community-based mental health sites in the UK. Participants were eligible if they were aged 18 years or older, and smoked at least five cigarettes per day. Exclusion criteria included substantial comorbid drug or alcohol problems and people who lacked capacity to consent at the time of recruitment. Using computer-generated random numbers, participants were randomly assigned (1:1) to a bespoke smoking cessation intervention or to usual care. Participants, mental health specialists, and primary care physicians were unmasked to assignment. The bespoke smoking cessation intervention consisted of behavioural support from a mental health smoking cessation practitioner and pharmacological aids for smoking cessation, with adaptations for people with severe mental illness-such as, extended pre-quit sessions, cut down to quit, and home visits. Access to pharmacotherapy was via primary care after discussion with the smoking cessation specialist. Under usual care participants were offered access to local smoking cessation services not specifically designed for people with severe mental illnesses. The primary endpoint was smoking cessation at 12 months ascertained via carbon monoxide measurements below 10 parts per million and self-reported cessation for the past 7 days. Secondary endpoints were biologically verified smoking cessation at 6 months; number of cigarettes smoked per day, Fagerström Test for Nicotine Dependence (FTND) and Motivation to Quit (MTQ) questionnaire; general and mental health functioning determined via the Patient Health Questionnaire-9 (PHQ-9), the Generalised Anxiety Disorder-7 (GAD-7) questionnaire, and 12-Item Short Form Health Survey (SF-12); and body-mass index (BMI). This trial was registerd with the ISRCTN registry, number ISRCTN72955454, and is complete.
FINDINGS
Between Oct 7, 2015, and Dec 16, 2016, 526 eligible patients were randomly assigned to the bespoke smoking cessation intervention (n=265) or usual care (n=261). 309 (59%) participants were male, median age was 47·2 years (IQR 36·3-54·5), with high nicotine dependence (mean 24 cigarettes per day [SD 13·2]), and the most common severe mental disorders were schizophrenia or other psychotic illness (n=343 [65%]), bipolar disorder (n=115 [22%]), and schizoaffective disorder (n=66 [13%]). 234 (88%) of intervention participants engaged with the treatment programme and attended 6·4 (SD 3·5) quit smoking sessions, with an average duration of 39 min (SD 17; median 35 min, range 5-120). Verified quit data at 12 months were available for 219 (84%) of 261 usual care and 223 (84%) of 265 intervention participants. The proportion of participants who had quit at 12 months was higher in the intervention group than in the usual care group, but non-significantly (34 [15%] of 223 [13% of those assigned to group] vs 22 [10%] of 219 [8% of those assigned to group], risk difference 5·2%, 95% CI -1·0 to 11·4; odds ratio [OR] 1·6, 95% CI 0·9 to 2·9; p=0·10). The proportion of participants who quit at 6 months was significantly higher in the intervention group than in the usual care group (32 [14%] of 226 vs 14 [6%] of 217; risk difference 7·7%, 95% CI 2·1 to 13·3; OR 2·4, 95% CI 1·2 to 4·6; p=0·010). The incidence rate ratio for number of cigarettes smoked per day at 6 months was 0·90 (95% CI 0·80 to 1·01; p=0·079), and at 12 months was 1·00 (0·89 to 1·13; p=0·95). At both 6 months and 12 months, the intervention group was non-significantly favoured in the FTND (adjusted mean difference 6 months -0·18, 95% CI -0·53 to 0·17, p=0·32; and 12 months -0·01, -0·39 to 0·38, p=0·97) and MTQ questionnaire (adjusted mean difference 0·58, -0·01 to 1·17, p=0·056; and 12 months 0·64, 0·04 to 1·24, p=0·038). The PHQ-9 showed no difference between the groups (adjusted mean difference at 6 months 0·20, 95% CI -0·85 to 1·24 vs 12 months -0·12, -1·18 to 0·94). For the SF-12 survey, we saw evidence of improvement in physical health in the intervention group at 6 months (adjusted mean difference 1·75, 95% CI 0·21 to 3·28), but this difference was not evident at 12 months (0·59, -1·07 to 2·26); and we saw no difference in mental health between the groups at 6 or 12 months (adjusted mean difference at 6 months -0·73, 95% CI -2·82 to 1·36, and 12 months -0·41, -2·35 to 1·53). The GAD-7 questionnaire showed no difference between the groups (adjusted mean difference at 6 months -0·32 95% CI -1·26 to 0·62 vs 12 months -0·10, -1·05 to 0·86). No difference in BMI was seen between the groups (adjusted mean difference 6 months 0·16, 95% CI -0·54 to 0·85; 12 months 0·25, -0·62 to 1·13).
INTERPRETATION
This bespoke intervention is a candidate model of smoking cessation for clinicians and policy makers to address high prevalence of smoking. The incidence of quitting at 6 months shows that smoking cessation can be achieved, but the waning of this effect by 12 months means more effort is needed for sustained quitting.
FUNDING
National Institute for Health Research Health Technology Assessment Programme.",2019,"The GAD-7 questionnaire showed no difference between the groups (adjusted mean difference at 6 months -0·32 95% CI -1·26 to 0·62 vs 12 months -0·10, -1·05 to 0·86).","['recruited heavy smokers with bipolar disorder or schizophrenia from 16 primary care and 21 community-based mental health sites in the UK', '309 (59%) participants were male, median age was 47·2 years (IQR 36·3-54·5), with high nicotine dependence (mean 24 cigarettes per day [SD 13·2]), and the most common severe mental disorders were schizophrenia or other psychotic illness (n=343 [65%]), bipolar disorder (n=115 [22%]), and schizoaffective disorder (n=66 [13', 'people with severe mental illnesses', 'Exclusion criteria included substantial comorbid drug or alcohol problems and people who lacked capacity to consent at the time of recruitment', 'Participants, mental health specialists, and primary care physicians', 'People with severe mental illnesses', 'people with severe mental illness (SCIMITAR', 'Under usual care participants', '526 eligible patients', 'people with severe mental illness', 'Participants were eligible if they were aged 18 years or older, and smoked at least five cigarettes per day']","['combined behavioural and pharmacological smoking cessation intervention', 'smoking cessation intervention', 'bespoke smoking cessation intervention or to usual care', 'Smoking cessation', 'bespoke smoking cessation intervention (n=265) or usual care', 'local smoking cessation services', 'behavioural support from a mental health smoking cessation practitioner and pharmacological aids for smoking cessation', 'pharmacotherapy']","['incidence rate ratio', 'BMI', 'smoking cessation at 12 months ascertained via carbon monoxide measurements below 10 parts per million and self-reported cessation', 'physical health', 'GAD-7 questionnaire', 'mental health', 'Generalised Anxiety Disorder-7 (GAD-7) questionnaire, and 12-Item Short Form Health Survey (SF-12); and body-mass index (BMI', 'MTQ questionnaire', 'biologically verified smoking cessation at 6 months; number of cigarettes smoked per day, Fagerström Test for Nicotine Dependence (FTND) and Motivation to Quit (MTQ) questionnaire; general and mental health functioning determined via the Patient Health Questionnaire-9']","[{'cui': 'C0857118', 'cui_str': 'Heavy smoker'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0201932', 'cui_str': 'Carboxyhemoglobin measurement (procedure)'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke (substance)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]",526.0,0.14132,"The GAD-7 questionnaire showed no difference between the groups (adjusted mean difference at 6 months -0·32 95% CI -1·26 to 0·62 vs 12 months -0·10, -1·05 to 0·86).","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, York, UK. Electronic address: simon.gilbody@york.ac.uk.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Peckham', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Della', 'Initials': 'D', 'LastName': 'Bailey', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Arundel', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Heron', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Crosland', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Bradshaw', 'Affiliation': 'Centre for Primary Care, University of Manchester, Manchester, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Horspool', 'Affiliation': 'Sheffield Health and Social Care NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hughes', 'Affiliation': 'Research and Development, University of Leeds, Leeds, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Hughes', 'Affiliation': 'Leeds and York Partnership NHS Foundation Trust, Leeds, UK.'}, {'ForeName': 'Suzy', 'Initials': 'S', 'LastName': 'Ker', 'Affiliation': 'Tees, Esk and Wear Valleys NHS Foundation Trust, Stockton-on-Tees, UK.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Leahy', 'Affiliation': 'Sheffield Health and Social Care NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Tayla', 'Initials': 'T', 'LastName': 'McCloud', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Reilly', 'Affiliation': 'Tees, Esk and Wear Valleys NHS Foundation Trust, Stockton-on-Tees, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Steare', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Ballantyne', 'Affiliation': 'Rotherham Doncaster and South Humber NHS Foundation Trust, Doncaster, UK.'}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Bidwell', 'Affiliation': 'Lancashire Care NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Bonner', 'Affiliation': 'Tees, Esk and Wear Valleys NHS Foundation Trust, Stockton-on-Tees, UK.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Brennan', 'Affiliation': 'Lincolnshire Partnership NHS Foundation Trust, Lincoln, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Callen', 'Affiliation': 'Solent NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carey', 'Affiliation': 'Sheffield Health and Social Care NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Colbeck', 'Affiliation': 'Sheffield Health and Social Care NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Coton', 'Affiliation': 'Sussex Partnership NHS Foundation Trust, Hove, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Donaldson', 'Affiliation': 'Berkshire Healthcare NHS Foundation Trust, Reading, UK.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Evans', 'Affiliation': 'Bradford District Care NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Herlihy', 'Affiliation': 'Kent and Medway NHS and Social Care Partnership Trust, Maidstone, UK.'}, {'ForeName': 'Wajid', 'Initials': 'W', 'LastName': 'Khan', 'Affiliation': 'South West Yorkshire NHS Foundation Trust, Wakefield, UK.'}, {'ForeName': 'Lizwi', 'Initials': 'L', 'LastName': 'Nyathi', 'Affiliation': 'Lincolnshire Partnership NHS Foundation Trust, Lincoln, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Nyamadzawo', 'Affiliation': 'Bradford District Care NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Oldknow', 'Affiliation': 'Rotherham Doncaster and South Humber NHS Foundation Trust, Doncaster, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Phiri', 'Affiliation': 'Southern Health NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Shanaya', 'Initials': 'S', 'LastName': 'Rathod', 'Affiliation': 'Southern Health NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Rea', 'Affiliation': 'Northumberland Tyne and Wear NHS Foundation Trust, Newcastle, UK.'}, {'ForeName': 'Crystal-Bella', 'Initials': 'CB', 'LastName': 'Romain-Hooper', 'Affiliation': 'Leeds and York Partnership NHS Foundation Trust, Leeds, UK.'}, {'ForeName': 'Kaye', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'Solent NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Stribling', 'Affiliation': 'Cambridge and Peterborough NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Carinna', 'Initials': 'C', 'LastName': 'Vickers', 'Affiliation': 'Somerset Partnership NHS Foundation Trust, South Petherton, UK.'}]",The lancet. Psychiatry,['10.1016/S2215-0366(19)30047-1']
661,30999779,Implementation of a behavioral medicine approach in physiotherapy: impact and sustainability.,"Purpose: To explore the effects on and sustainability of physiotherapists' clinical behavior when using facilitation to support the implementation of a behavioral medicine approach in primary health care for patients with persistent musculoskeletal pain. Methods: A quasi-experimental pre-/post-test trial was conducted. Fifteen physiotherapists were included in the experimental group, and nine in the control group. Based on social cognitive theory and the Promoting Action on Research Implementation in Health Services framework, facilitation with multifaceted implementation methods was used during a six-month period. Clinical behaviors were investigated with a study-specific questionnaire, structured observations, self-reports and patient records. Descriptive and non-parametric statistical methods were used for analyzing differences over time and effect size. Results: A sustained increase in self-efficacy for applying the behavioral medicine approach was found. Clinical actions and verbal expressions changed significantly, and the effect size was large; however, changes were not sustained at follow-ups. The behavioral changes were mainly related to the goal setting, self-monitoring and functional behavioral analysis components. No changes in clinical behavior were found in the control group. Conclusion: Tailored multifaceted facilitation can support the implementation of a behavioral medicine approach in physiotherapy in primary health care, but more comprehensive actions targeting sustainability are needed.Implications for rehabilitationTailored multifaceted facilitation can support the implementation of an evidence based behavioral medicine approach in physiotherapy.Facilitation can be useful for increasing self-efficacy beliefs for using behavioral medicine approach in physiotherapist's clinical practice.Further research is required to establish strategies that are effective in sustaining behavioral changes.",2020,"Clinical actions and verbal expressions changed significantly, and the effect size was large; however, changes were not sustained at follow-ups.","['patients with persistent musculoskeletal pain', 'Fifteen physiotherapists were included in the experimental group, and nine in the control group']",['behavioral medicine approach'],"['clinical behavior', 'Clinical actions and verbal expressions', 'self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004937', 'cui_str': 'Behavioral Medicine'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",15.0,0.0261929,"Clinical actions and verbal expressions changed significantly, and the effect size was large; however, changes were not sustained at follow-ups.","[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Fritz', 'Affiliation': 'School of Health, Care and Social Welfare, Mälardalen University, Västerås, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallin', 'Affiliation': 'School of Education, Health and Social Studies, Dalarna University, Falun, Sweden.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Söderlund', 'Affiliation': 'School of Health, Care and Social Welfare, Mälardalen University, Västerås, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Almqvist', 'Affiliation': 'School of Health, Care and Social Welfare, Mälardalen University, Västerås, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sandborgh', 'Affiliation': 'School of Health, Care and Social Welfare, Mälardalen University, Västerås, Sweden.'}]",Disability and rehabilitation,['10.1080/09638288.2019.1596170']
662,30994951,Comparison of postoperative voice outcomes after postauricular facelift robotic hemithyroidectomy and conventional transcervical hemithyroidectomy.,"BACKGROUND
The purpose of this study was to determine whether postauricular robotic and conventional hemithyroidectomy result in significantly different voice outcomes.
METHODS
We prospectively compared the voice handicap index (VHI)-10 and acoustic parameters of a postauricular facelift robotic group and a conventional group preoperatively, 1 week, 1 month, and 6 months after surgery.
RESULTS
Forty-two patients in the postauricular group and 68 patients in the conventional group completed the VHI-10 questionnaire and acoustic analysis. The postoperative VHI-10 scores were not significantly different between the two groups. In female patients, the highest frequency was higher and the frequency range was wider in the postauricular group compared to the conventional group postoperatively until 1 month after surgery.
CONCLUSION
Postauricular facelift robotic thyroidectomy has advantages over conventional thyroidectomy in terms of postoperative voice pitch.",2019,"In female patients, the highest frequency was higher and the frequency range was wider in the postauricular group compared to the conventional group postoperatively until 1 month after surgery.
",[],"['postauricular facelift robotic hemithyroidectomy and conventional transcervical hemithyroidectomy', 'Postauricular facelift robotic thyroidectomy', 'postauricular robotic and conventional hemithyroidectomy']","['VHI-10 questionnaire and acoustic analysis', 'voice handicap index (VHI)-10 and acoustic parameters', 'highest frequency', 'frequency range', 'postoperative VHI-10 scores']",[],"[{'cui': 'C0442168', 'cui_str': 'Postauricular (qualifier value)'}, {'cui': 'C0035519', 'cui_str': 'Facelift'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine (qualifier value)'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index (assessment scale)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0439326,"In female patients, the highest frequency was higher and the frequency range was wider in the postauricular group compared to the conventional group postoperatively until 1 month after surgery.
","[{'ForeName': 'Chang M', 'Initials': 'CM', 'LastName': 'Song', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Min S', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Dong W', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Yong B', 'Initials': 'YB', 'LastName': 'Ji', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Jung H', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Dong S', 'Initials': 'DS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung', 'Initials': 'K', 'LastName': 'Tae', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University, Seoul, Republic of Korea.'}]",Head & neck,['10.1002/hed.25777']
663,30791950,Parents of healthy children assign lower quality of life measure to scenarios labeled as cancer than to identical scenarios not labeled as cancer.,"BACKGROUND
While it is commonly understood that a cancer diagnosis evokes feelings of fear, the effect of labeling a child's illness as ""cancer"" remains unstudied. We hypothesized that lower health utility scores would be assigned to disease states labeled as cancer compared to identical disease states without the mention of cancer.
METHODS
In this randomized study, caregivers of healthy children were asked to assign health utility values to different scenarios written as improving, stable, or worsening. Participants from general pediatric clinics at Eskenazi Health were randomly assigned to either the scenarios labeled as ""cancer"" or ""a serious illness"". Participants then rated the scenarios using the Standard Gamble, with laddering of health utilities between 0 (a painless death) and 1 (perfect health). We also gathered subject demographics and assessed the subject's numeracy.
RESULTS
We approached 319 subjects and 167 completed the study. Overall median health utilities of ""cancer"" scenarios were lower than ""serious illness"" scenarios (0.61 vs. 0.72, p = 0.018). Multivariate regression (with an outcome of having a utility above the 75th percentile) showed no significant effects by race, ethnicity, numeracy, or income level. ""Cancer"" scenarios remained significantly lower after adjustment for confounders using logistic regression, but only for the more serious scenarios (OR 0.92, p = 0.048).
CONCLUSIONS
On average, caregivers with healthy children were shown to take more risk with their treatment options and view their child as having a worse quality of life when they knew the disease was cancer. Awareness of this bias is important when discussing treatments with families, particularly when a risk of cancer is present.",2019,"Overall median health utilities of ""cancer"" scenarios were lower than ""serious illness"" scenarios (0.61 vs. 0.72, p = 0.018).","['319 subjects and 167 completed the study', 'caregivers of healthy children', 'Parents of healthy children', 'Participants from general pediatric clinics at Eskenazi Health', 'caregivers with healthy children']","['scenarios labeled as ""cancer"" or ""a serious illness']","['Overall median health utilities of ""cancer"" scenarios', 'race, ethnicity, numeracy, or income level. ']","[{'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",319.0,0.0538511,"Overall median health utilities of ""cancer"" scenarios were lower than ""serious illness"" scenarios (0.61 vs. 0.72, p = 0.018).","[{'ForeName': 'Brenna M', 'Initials': 'BM', 'LastName': 'McElderry', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, USA. bmcelder@indiana.edu.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Mueller', 'Affiliation': 'Center for Pediatric and Adolescent Comparative Effectiveness Research, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Indiana University, Bloomington, USA.'}, {'ForeName': 'Aaron E', 'Initials': 'AE', 'LastName': 'Carroll', 'Affiliation': 'Center for Pediatric and Adolescent Comparative Effectiveness Research, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Bennett', 'Affiliation': 'Center for Pediatric and Adolescent Comparative Effectiveness Research, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, USA.'}]",BMC psychology,['10.1186/s40359-019-0280-5']
664,31938840,Assessment of the effects of autologous muscle-derived cell injections on urethral sphincter morphometry using 3D/4D ultrasound.,"PURPOSE
The primary objective was to evaluate the effect of autologous muscle-derived cell (AMDC) injections on the urethral sphincter morphometry compared to placebo injections. Secondary aims were to explore the reduction of stress incontinence episode frequency (IEF) and factors associated with the efficacy of AMDC.
METHODS
This prospective randomized-controlled study compared the urethral sphincter volumes of participants who had received either an intra-sphincteric injection of 4 cc AMDC in injection media or 4 cc placebo solution, using a transperineal 3D/4D ultrasound at baseline and at 12 months. The reduction of stress IEF on 3-day bladder diary and potential predictors at baseline for response to AMDC were assessed.
RESULTS
Fifty-eight participants were included in the study. Compared to baseline, the mean total and external sphincter volumes increased significantly in both groups (respectively, p = 0.001 and p < 0.001 in the AMDC group, p < 0.001 and p = 0.005 in the placebo group) at 12 months. Both groups showed a significant reduction of stress IEF compared to baseline (p = 0.03 and p ≤ 0.001 for AMDC and placebo groups, respectively). There were no between-group differences regarding total and external sphincter volumes and reduction of stress IEF. A longer urethral length (p ≤ 0.001) and a larger external sphincter volume (p ≤ 0.05) were significantly associated with lower stress IEF.
CONCLUSION
Significant increases of sphincter volumes as well as reduction of stress IEF occurred among the AMDC and placebo injection groups with no between-group differences at 12 months. A longer urethral length and a larger external sphincter volume at baseline were identified as potential predictors of AMDC injection response.",2020,"Both groups showed a significant reduction of stress IEF compared to baseline (p = 0.03 and p ≤ 0.001 for AMDC and placebo groups, respectively).","['Fifty-eight participants were included in the study', 'participants who had received either an']","['autologous muscle-derived cell injections', 'autologous muscle-derived cell (AMDC) injections', 'intra-sphincteric injection of 4\xa0cc AMDC in injection media or 4\xa0cc placebo solution', 'placebo', 'placebo injections']","['stress incontinence episode frequency (IEF) and factors associated with the efficacy of AMDC', 'sphincter volumes', 'larger external sphincter volume', 'urethral length', 'mean total and external sphincter volumes', 'total and external sphincter volumes and reduction of stress IEF', 'stress IEF', 'urethral length and a larger external sphincter volume']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0041967', 'cui_str': 'Urethra'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",58.0,0.0603985,"Both groups showed a significant reduction of stress IEF compared to baseline (p = 0.03 and p ≤ 0.001 for AMDC and placebo groups, respectively).","[{'ForeName': 'Salima', 'Initials': 'S', 'LastName': 'Ismail', 'Affiliation': 'Department of Surgery, Division of Urology, Faculty of Medicine and Health Sciences, Université de Sherbrooke and Research Center of the Centre Hospitalier Universitaire de Sherbrooke (CHUS), Sherbrooke, QC, Canada.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Morin', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke and Research Center of the CHUS, Sherbrooke, QC, Canada.'}, {'ForeName': 'Le Mai', 'Initials': 'LM', 'LastName': 'Tu', 'Affiliation': 'Department of Surgery, Division of Urology, Faculty of Medicine and Health Sciences, Université de Sherbrooke and Research Center of the Centre Hospitalier Universitaire de Sherbrooke (CHUS), Sherbrooke, QC, Canada. le.mai.tu@USherbrooke.ca.'}]",World journal of urology,['10.1007/s00345-020-03076-4']
665,31719675,Longitudinal neovascular changes on optical coherence tomography angiography in proliferative diabetic retinopathy treated with panretinal photocoagulation alone versus with intravitreal conbercept plus panretinal photocoagulation: a pilot study.,"PURPOSE
To investigate the longitudinal changes in neovascularization of the retinal elsewhere (NVE) size on optical coherence tomography angiography (OCTA) in proliferative diabetic retinopathy (PDR) treated by panretinal photocoagulation (PRP) alone or by single intravitreal conbercept injection plus PRP.
METHODS
A prospective pilot study. Forty-four PDR eyes with NVE confirmed by fundus fluorescein angiography (FFA) and OCTA were included. They were assigned to receive PRP alone (PRP group) or intravitreal conbercept injection plus PRP (combination group). Ophthalmic examinations, including BCVA and OCTA to measure the NVE size, were performed at baseline before each PRP session, and at 1, 3, and 6 months.
RESULTS
Twenty-nine eyes were included in the PRP group, and 15 eyes were included in the combination group. There was no significant difference between the two groups with respect to age, BCVA, and NVE area at baseline. In both groups, there was a significant (P < 0.05) NVE size reduction during the majority of study visits, with the reduction observed in the combination group significantly larger than that in the PRP group. No significant BCVA changes were observed in either groups, except that in the PRP group, the BCVA at 3 months was significantly improved (P < 0.05). No deaths or unexpected adverse events (AEs) were reported.
CONCLUSIONS
Intravitreal conbercept plus PRP was more effective than PRP monotherapy in NVE regression. Precise quantification of the NVE area by OCTA makes it a useful tool for monitoring the response of retinal neovascular lesions to the therapy.",2020,"There was no significant difference between the two groups with respect to age, BCVA, and NVE area at baseline.","['proliferative diabetic retinopathy treated with', 'Forty-four PDR eyes with NVE confirmed by fundus fluorescein angiography (FFA) and OCTA were included', 'proliferative diabetic retinopathy (PDR', 'Twenty-nine eyes were included in the PRP group, and 15 eyes were included in the combination group']","['optical coherence tomography angiography', 'intravitreal conbercept plus panretinal photocoagulation', 'PRP alone (PRP group) or intravitreal conbercept injection plus PRP', 'panretinal photocoagulation alone', 'panretinal photocoagulation (PRP) alone or by single intravitreal conbercept injection plus PRP', 'optical coherence tomography angiography (OCTA']","['No deaths or unexpected adverse events (AEs', 'NVE size reduction', 'BCVA changes', 'BCVA and OCTA to measure the NVE size', 'BCVA']","[{'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0430878', 'cui_str': 'Retinal angiography'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0730064', 'cui_str': 'Scatter retinal laser photocoagulation'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",44.0,0.0175467,"There was no significant difference between the two groups with respect to age, BCVA, and NVE area at baseline.","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Key Lab of Ocular Fundus Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Key Lab of Ocular Fundus Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. yuweihongeye@foxmail.com.'}]","Eye (London, England)",['10.1038/s41433-019-0628-3']
666,31016503,"Growth Trajectories of Peer Norms, Self-efficacy and Condom Use Behavior Among Sexually Active Chinese Men Who Have Sex with Men: Latent Class Analysis and Growth Mixture Modeling.","Data from a randomized controlled trial in 2015 were used to estimate the growth trajectories of peer norms, self-efficacy, and condom use behavior, and to identify associated sociodemographic and behavioral factors among a sample of 804 Chinese men who have sex with men (MSM). Latent class analysis and growth mixture modeling were conducted using Mplus. Two growth trajectories were estimated for each outcome variable with good model fit. The growth trajectories of peer norms were related to age (β = - 0.066, p < 0.05). The growth trajectories of self-efficacy were related to age (β = 0.057, p < 0.01) and using a condom during first sexual encounter with another man (β = 0.777, p < 0.001). The growth trajectories of condom use behavior were related to income (β = 0.366, p < 0.01) and having casual male partners (β = - 1.016, p < 0.001). Predictors for the growth factors within each latent class were also estimated. For subsets of MSM who are older, richer, used a condom during their first sexual encounter with another man, and do not have a casual male partner, condom videos may not have sufficient efficacy and other interventions may be necessary.",2020,"The growth trajectories of condom use behavior were related to income (β = 0.366, p < 0.01) and having casual male partners (β = - 1.016, p < 0.001).","['Sexually Active Chinese Men', '804 Chinese men who have sex with men (MSM', 'Who Have Sex with Men']",[],"['growth trajectories of peer norms', 'growth trajectories of condom use behavior', 'growth trajectories of self-efficacy', 'Growth Trajectories of Peer Norms, Self-efficacy and Condom Use Behavior']","[{'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]",[],"[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",804.0,0.0225849,"The growth trajectories of condom use behavior were related to income (β = 0.366, p < 0.01) and having casual male partners (β = - 1.016, p < 0.001).","[{'ForeName': 'Haochu', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shandong University, 44 West Wenhua Road, Jinan, 250012, Shandong, China. haochuli@yahoo.com.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'UNC Project-China, Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shandong University, 44 West Wenhua Road, Jinan, 250012, Shandong, China.'}, {'ForeName': 'Eun Sook', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Department of Educational and Psychological Studies, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Gifty', 'Initials': 'G', 'LastName': 'Marley', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dianmin', 'Initials': 'D', 'LastName': 'Kang', 'Affiliation': 'Shandong Provincial Center for Disease Control and Prevention, Jinan, China.'}, {'ForeName': 'Meizhen', 'Initials': 'M', 'LastName': 'Liao', 'Affiliation': 'Shandong Provincial Center for Disease Control and Prevention, Jinan, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'UNC Project-China, Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Baofa', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shandong University, 44 West Wenhua Road, Jinan, 250012, Shandong, China.'}]",AIDS and behavior,['10.1007/s10461-019-02515-7']
667,30961460,Omega-3 and vitamin E co-supplementation can improve antioxidant markers in obese/overweight women with polycystic ovary syndrome.,"Background: Polycystic ovary syndrome is one of the most important factors in female infertility. Oxidative stress is likely to contribute to increased insulin and androgen production in the ovaries, as well as probably impairing follicle production. Aims: This study aims to determine the complementary effects of omega-3 and vitamin E supplements on certain oxidative stress indices in obese and overweight women with polycystic ovary syndrome. Materials and Methods: This double-blind, randomized clinical trial was performed on polycystic ovary syndrome subjects with BMI > 25. Patients were randomly allocated into two groups to receive either 2 g of omega-3 plus 400 IU of vitamin E, or a placebo, for 8 weeks. At the beginning and the end of the study, total antioxidant capacity, glutathione levels, catalase activity, malondialdehyde concentrations, as well as dietary intake and physical activity were evaluated. Statistical analysis was performed using SPSS. Results: 32 patients in the intervention group and 30 patients in the placebo group completed the study. Co-supplementation of omega-3 and vitamin E significantly increased total antioxidant capacity (mg/dl) (1.15 ± 0.93 vs -0.6 ± 0.72; P < 0.001), catalase activity (IU/L) (1.19 ± 1.06 vs 0.12 ± 0.36; P < 0.001) and glutathione levels (μmol/L) (1.5 ± 1.06 vs 0.23 ± 1.43; P = 0.028). Additionally, a significant reduction of malondialdehyde levels (nmol/L) (-0.34 ± 0.32 vs 0.57 ± 2.20; P = 0.008) was observed, in comparison with placebo. Conclusion: Co-supplementation with omega-3 and vitamin E had beneficial effect on total antioxidant capacity, malondialdehyde concentrations, glutathione levels and catalase activity.",2020,"had beneficial effect on total antioxidant capacity, malondialdehyde concentrations, glutathione levels and catalase activity.","['obese/overweight women with polycystic ovary syndrome', 'obese and overweight women with polycystic ovary syndrome', '32 patients in the intervention group and 30 patients in the', 'polycystic ovary syndrome subjects with BMI\xa0>\xa025']","['placebo', 'omega-3 plus 400\xa0IU of vitamin E, or a placebo', 'Co-supplementation with omega-3 and vitamin E', 'omega-3 and vitamin E supplements', 'Omega-3 and vitamin E co-supplementation', 'omega-3 and vitamin E']","['antioxidant markers', 'certain oxidative stress indices', 'total antioxidant capacity, glutathione levels, catalase activity, malondialdehyde concentrations, as well as dietary intake and physical activity', 'malondialdehyde levels', 'glutathione levels', 'total antioxidant capacity, malondialdehyde concentrations, glutathione levels and catalase activity', 'catalase activity', 'total antioxidant capacity']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C3661607', 'cui_str': 'Vitamin E supplement'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.536945,"had beneficial effect on total antioxidant capacity, malondialdehyde concentrations, glutathione levels and catalase activity.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amirmansour', 'Initials': 'A', 'LastName': 'Alavi-Naeini', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Mardanian', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Ghazvini', 'Affiliation': 'Isfahan Center of Health Research, National Institute of Health Research, Isfahan, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Mahaki', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition,['10.1024/0300-9831/a000588']
668,29398050,"Lipid Profiles, Inflammatory Markers, and Insulin Therapy in Youth with Type 2 Diabetes.","OBJECTIVES
Data regarding atherogenic dyslipidemia and the inflammation profile in youth with type 2 diabetes is limited and the effect of insulin therapy on these variables has not previously been studied in youth. We determined the impact of insulin therapy on lipid and inflammatory markers in youth with poorly controlled type 2 diabetes.
STUDY DESIGN
In the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) multicenter trial, 285 participants failed to sustain glycemic control on randomized treatment (primary outcome, glycated hemoglobin A1c [HbA1c] at ≥8% for 6 months); 363 maintained glycemic control (never reached primary outcome). Statins were used for a low-density lipoprotein cholesterol of ≥130 mg/dL. Upon reaching the primary outcome, insulin was started. Changes in lipids and inflammatory markers (slopes over time) were examined.
RESULTS
Progression of dyslipidemia was related to glycemic control. In those with the primary outcome, insulin therapy impacted HbA1c modestly, and dampened the increase in total cholesterol, low-density lipoprotein cholesterol, and total apolipoprotein B, although statin use increased from 8.6% to 22% year after the primary outcome. The increase in triglycerides and plasma nonesterified fatty acids stabilized after insulin was started, independent of HbA1c. There was an increase in high-sensitivity C-reactive protein that continued after insulin initiation, related to HbA1c and percent overweight.
CONCLUSIONS
Worsening dyslipidemia and inflammation over time raise concern regarding premature development of atherosclerosis in youth with type 2 diabetes. Insulin therapy has a limited benefit in the absence of glycemic control. Strategies to achieve better glycemic control are needed.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT00081328.",2018,"There was an increase in high-sensitivity C-reactive protein that continued after insulin initiation, related to HbA1c and percent overweight.
","['285 participants failed to sustain glycemic control on randomized treatment (primary outcome, glycated hemoglobin A1c [HbA1c] at ≥8% for 6 months); 363 maintained glycemic control (never reached primary outcome', 'youth with type 2 diabetes', 'youth with poorly controlled type 2 diabetes', 'Youth with Type 2 Diabetes']","['Insulin therapy', 'insulin therapy']","['total cholesterol, low-density lipoprotein cholesterol, and total apolipoprotein B, although statin use', 'insulin therapy impacted HbA1c modestly', 'lipid and inflammatory markers', 'triglycerides and plasma nonesterified fatty acids stabilized', 'high-sensitivity C-reactive protein']","[{'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4505389', 'cui_str': 'Glycosylated Hemoglobin A1c'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",285.0,0.185721,"There was an increase in high-sensitivity C-reactive protein that continued after insulin initiation, related to HbA1c and percent overweight.
","[{'ForeName': 'Lorraine E', 'Initials': 'LE', 'LastName': 'Levitt Katz', 'Affiliation': ""Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Fida', 'Initials': 'F', 'LastName': 'Bacha', 'Affiliation': ""Texas Children's Hospital, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Gidding', 'Affiliation': 'Nemours Cardiac Center, Alfred I. DuPont Hospital for Children, Wilmington, DE.'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'SUNY Upstate Medical University, Department of Medicine, Syracuse, NY.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'El Ghormli', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, MD. Electronic address: elghorml@bsc.gwu.edu.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Libman', 'Affiliation': ""Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA.""}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Porter', 'Affiliation': ""Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA.""}, {'ForeName': 'Santica', 'Initials': 'S', 'LastName': 'Marcovina', 'Affiliation': 'Northwest Lipid Research Laboratories, University of Washington, Seattle, WA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2017.12.052']
669,30894279,"Serlopitant reduced pruritus in patients with prurigo nodularis in a phase 2, randomized, placebo-controlled trial.","BACKGROUND
Anecdotal evidence suggests that neurokinin 1 receptor antagonism reduces pruritus intensity in chronic pruritic conditions such as prurigo nodularis (PN).
OBJECTIVE
This study assessed safety and efficacy of the neurokinin 1 receptor antagonist serlopitant for treatment of pruritus in PN.
METHODS
In this randomized, double-blind, placebo-controlled study, 128 patients with chronic, treatment-refractory PN for more than 6 weeks received serlopitant, 5 mg, or placebo orally once daily for 8 weeks. The primary end point was change in average itch visual analog scale score at weeks 4 and 8.
RESULTS
Average itch visual analog scale scores significantly improved with serlopitant versus with placebo at weeks 4 and 8: the least squares mean difference (serlopitant minus placebo) was -1.0 at week 4 (P = .02) and -1.7 at week 8 (P < .001). The least squares mean difference between serlopitant and placebo reached statistical significance at week 2 (-0.9 [P = .011]). The most frequently reported treatment-emergent adverse events in the serlopitant group were nasopharyngitis, diarrhea, and fatigue.
LIMITATIONS
The 8-week duration may be insufficient to assess clinically relevant resolution of PN lesions.
CONCLUSIONS
Serlopitant reduced pruritus in patients with treatment-refractory PN and was well tolerated.",2019,"RESULTS
Average itch visual analog scale scores significantly improved with serlopitant versus with placebo at weeks 4 and 8: the least squares mean difference (serlopitant minus placebo) was -1.0 at week 4 (P = .02) and -1.7 at week 8 (P < .001).","['128 patients with chronic, treatment-refractory PN for more than 6\xa0weeks received']","['serlopitant, 5\xa0mg, or placebo', 'placebo']","['safety and efficacy', 'tolerated', 'pruritus', 'nasopharyngitis, diarrhea, and fatigue', 'average itch visual analog scale score', 'Average itch visual analog scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C2825662', 'cui_str': 'serlopitant'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",128.0,0.735584,"RESULTS
Average itch visual analog scale scores significantly improved with serlopitant versus with placebo at weeks 4 and 8: the least squares mean difference (serlopitant minus placebo) was -1.0 at week 4 (P = .02) and -1.7 at week 8 (P < .001).","[{'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Ständer', 'Affiliation': 'Center for Chronic Pruritus, Department of Dermatology, University Hospital Münster, Münster, Germany. Electronic address: Sonja.Staender@uni-muenster.de.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kwon', 'Affiliation': 'Menlo Therapeutics Inc, Redwood City, California.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Hirman', 'Affiliation': 'Pacific Northwest Statistical Consulting, Inc, Woodinville, Washington.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Perlman', 'Affiliation': 'Velocity Pharmaceutical Development, LLC, South San Francisco, California.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Weisshaar', 'Affiliation': 'Department of Clinical Social Medicine, Occupational and Environmental Dermatology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Metz', 'Affiliation': 'Department of Dermatology, Venerology, and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Luger', 'Affiliation': 'Department of Dermatology, University Hospital Münster, Münster, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.01.052']
670,31712590,Autonomic adaptations mediate the effect of hydration on brain functioning and mood: Evidence from two randomized controlled trials.,"Dehydration (water loss >2.0% of body weight) has significant negative effects on physical and mental performance. In two studies the effects of minor hypo-hydration (water loss <1.0% of body weight) on CNS function, mood and cardiovascular functioning were measured. Study 1: On two mornings twelve male participants were exposed to a temperature of 30 °C for four hours and either did or did not drink two 150 ml glasses of water during that time. Study 2: Fifty-six (25 M) individuals were exposed to the same 30 °C environment and randomly allocated to either drink (2 × 150 ml) or not drink. When not given water 0.59% (Study 1) and 0.55% (Study 2) bodyweight was lost. Participant's heart rate variability (HRV) was measured, and they rated their thirst and mood. In study 1, participants participated in an fMRI protocol during which they completed a modified version of the Paced Auditory Serial Addition Test (PASAT), at the end of which they rated its difficulty. Decreases in fMRI BOLD activity in the orbito-frontal cortex, ventral cingulate gyrus, dorsal cingulate cortex, hypothalamus, amygdala, right striatum, post-central gyrus and superior parietal cortex were observed when participants were hypo-hydrated. These deactivations were associated with reduced HRV, greater perceived effort, and more anxiety. In study 2 declines in HRV were found to mediate the effect of hypo-hydration on ratings of anxiety. These data are discussed in relation to a model that describes how autonomic regulatory and interoceptive processes may contribute to the affective consequences of minor hypo-hydration.",2019,"Decreases in fMRI BOLD activity in the orbito-frontal cortex, ventral cingulate gyrus, dorsal cingulate cortex, hypothalamus, amygdala, right striatum, post-central gyrus and superior parietal cortex were observed when participants were hypo-hydrated.","['participants participated in an fMRI protocol during which they completed a modified version of the', 'two mornings twelve male participants', 'Study 2: Fifty-six (25\u2009M) individuals were exposed to the same 30\u2009°C environment and randomly allocated to either']","['temperature of 30\u2009°C for four hours and either did or did not drink two 150', 'hydration', 'Paced Auditory Serial Addition Test (PASAT', 'drink (2\u2009×\u2009150\u2009ml) or not drink']","['reduced HRV, greater perceived effort, and more anxiety', 'CNS function, mood and cardiovascular functioning', ""Participant's heart rate variability (HRV"", 'Dehydration', 'ventral cingulate gyrus, dorsal cingulate cortex, hypothalamus, amygdala, right striatum, post-central gyrus and superior parietal cortex', 'fMRI BOLD activity', 'physical and mental performance']","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0566278', 'cui_str': 'Does not drink (finding)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0589060', 'cui_str': 'Paced Auditory Serial Addition Test'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0018427', 'cui_str': 'Cingulate Body'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0598179', 'cui_str': 'Cingulate Cortex'}, {'cui': 'C0020663', 'cui_str': 'Preoptico-Hypothalamic Area'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0030560', 'cui_str': 'Parietal Cortex'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",2.0,0.0770728,"Decreases in fMRI BOLD activity in the orbito-frontal cortex, ventral cingulate gyrus, dorsal cingulate cortex, hypothalamus, amygdala, right striatum, post-central gyrus and superior parietal cortex were observed when participants were hypo-hydrated.","[{'ForeName': 'Hayley A', 'Initials': 'HA', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, SA2 8PP, Wales, UK. h.a.young@swansea.ac.uk.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Cousins', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, SA2 8PP, Wales, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Johnston', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, SA2 8PP, Wales, UK.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Fletcher', 'Affiliation': 'PepsiCo, 100 Summit Lake Drive, Valhalla, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Benton', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, SA2 8PP, Wales, UK.'}]",Scientific reports,['10.1038/s41598-019-52775-5']
671,31712967,The Efficacy of a Gambling Prevention Program Among High-School Students.,"Youth problem gambling has become an emergent public health issue, and adolescents constitute a vulnerable age group for the development of gambling-related problems. Although there is research concerning the risk factors of youth problem gambling, rigorous evaluations of the effectiveness of preventive initiatives is still rare. The present study evaluated the efficacy of an integrative intervention to prevent youth problem gambling based on a multidimensional set of factors including gambling-related knowledge, misconceptions, attitudes, gambling frequency, amount of money spent, total hours spent gambling per week, and sensation seeking. A pre- and post-test design was performed with 111 Portuguese high-school students randomly assigned to two groups (experimental and control). The findings demonstrated that the intervention was effective in improving correct knowledge about gambling, reducing misconceptions and attitudes, and in decreasing the total hours spent gambling per week. The intervention was also effective in reducing the number of at-risk/problem gamblers during the study period. Furthermore, these findings were stable after a 6-week follow-up. Overall, the intervention program appeared to be effective in correcting some gambling-related behaviours, and provides suggestions for future interventions.",2020,"The findings demonstrated that the intervention was effective in improving correct knowledge about gambling, reducing misconceptions and attitudes, and in decreasing the total hours spent gambling per week.","['High-School Students', '111 Portuguese high-school students']","['Gambling Prevention Program', 'integrative intervention']","['number of at-risk/problem gamblers', 'correct knowledge about gambling, reducing misconceptions and attitudes']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0032730', 'cui_str': 'Portuguese (ethnic group)'}]","[{'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.018052,"The findings demonstrated that the intervention was effective in improving correct knowledge about gambling, reducing misconceptions and attitudes, and in decreasing the total hours spent gambling per week.","[{'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Calado', 'Affiliation': 'Department of Psychology, Nottingham Trent University, 50 Shakespeare Street, Nottingham, NG1 4FQ, UK. filipa.calado2013@my.ntu.ac.uk.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Alexandre', 'Affiliation': 'Department of Psychology, ISCTE - CIS/IUL - Lisbon University Institute, Avenida das Forças Armadas, 1649-026, Lisbon, Portugal.'}, {'ForeName': 'Liah', 'Initials': 'L', 'LastName': 'Rosenfeld', 'Affiliation': 'Department of Psychology, ISCTE - CIS/IUL - Lisbon University Institute, Avenida das Forças Armadas, 1649-026, Lisbon, Portugal.'}, {'ForeName': 'Rafaela', 'Initials': 'R', 'LastName': 'Pereira', 'Affiliation': 'Department of Psychology, ISCTE - CIS/IUL - Lisbon University Institute, Avenida das Forças Armadas, 1649-026, Lisbon, Portugal.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Griffiths', 'Affiliation': 'Department of Psychology, Nottingham Trent University, 50 Shakespeare Street, Nottingham, NG1 4FQ, UK.'}]",Journal of gambling studies,['10.1007/s10899-019-09908-2']
672,31712981,Root caries lesions inhibition and repair using commercial high-fluoride toothpastes with or without tri-calcium phosphate and conventional toothpastes containing or not 1.5% arginine CaCO 3 : an in situ investigation.,"OBJECTIVES
This double-blind, crossover, and in situ study evaluated the effect of commercial high-F toothpastes with or without functionalized β-tri-calcium phosphate (fTCP) and conventional-F toothpaste containing or not 1.5% arginine-CaCO 3 in preventing and repairing root caries-like lesions.
METHODS
Twelve volunteers wore palatal appliances containing sound (S) and pre-demineralized (PD) bovine root dentin blocks in 4 phases of 14 days/each. They used F toothpastes, 3×/day: (i) 1,450 μg F/g (conventional-F); (ii) 1,450 μg F/g + 1.5% arginine-CaCO 3 (conventional-F + arginine/CaCO 3 ); (iii) 5,000 μg F/g (high-F); and (iv) 5,000 μg F/g (high-F + fTCP). Sucrose solution (20%) was dropped 8×/day on the S blocks. The demineralization in the S blocks and the remineralization in the PD ones were estimated by % of surface hardness difference (%SH-S) and % of SH recovery (%SHR-PD), respectively. Caries lesion area (ΔS) was determined in the blocks. Statistical analyses were performed by one-way ANOVA/Kruskal-Wallis and multiple comparisons tests (p < 0.05).
RESULTS
Both high-F toothpastes presented similar effect to prevent early caries lesions and it was higher than conventional-F + arginine/CaCO 3. All treatments resulted in significantly lower ΔS values compared with conventional-F toothpaste (p < 0.0001). High-F + fTCP showed non-significantly higher preventive and reversible effect compared to high-F. The effect of conventional-F + arginine/CaCO 3 was similar to high-F and lower than high-F + fTCP in preventing and reverting in-deep caries lesions.
CONCLUSIONS
Overall, high-F toothpastes seem to be more effective and interesting feasible strategy for both prevention and remineralization actions in root dentin.
CLINICAL RELEVANCE
With the trend of increasing dentin root caries, this study brings new evidences about the preventive and repair effect of high-F toothpastes with or without fTCP in root caries and support the use of arginine in toothpastes.",2020,Both high-F toothpastes presented similar effect to prevent early caries lesions and it was higher than conventional-F + arginine/CaCO 3. ,"['i) 1,450\xa0μg', 'Twelve volunteers wore', 'iii) 5,000\xa0μg']","['commercial high-F toothpastes with or without functionalized β-tri-calcium phosphate (fTCP) and conventional-F toothpaste containing or not 1.5% arginine-CaCO', 'palatal appliances containing sound (S) and pre-demineralized (PD) bovine root dentin blocks', 'conventional-F toothpaste', 'F toothpastes, 3×/day', 'F/g (conventional-F); (ii) 1,450\xa0μg', 'High-F + fTCP', 'Sucrose solution', 'high-F + fTCP', 'commercial high-fluoride toothpastes with or without tri-calcium phosphate and conventional toothpastes containing or not 1.5% arginine CaCO 3 ', 'F/g\u2009+\u20091.5% arginine-CaCO 3 (conventional-F + arginine/CaCO 3 ']","['early caries lesions', 'dentin root caries', 'SH recovery', 'Caries lesion area (ΔS']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0243112'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0649543', 'cui_str': '4-fluoro-1-(1-(2-thienyl)cyclohexyl)piperidine'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0162644', 'cui_str': 'Root Caries'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",12.0,0.0474595,Both high-F toothpastes presented similar effect to prevent early caries lesions and it was higher than conventional-F + arginine/CaCO 3. ,"[{'ForeName': 'Marilia Mattar', 'Initials': 'MM', 'LastName': 'de Amoêdo Campos Velo', 'Affiliation': 'Department of Operative Dentistry, Endodontics and Dental Materials, Bauru School of Dentistry, University of São Paulo, Al. Dr Otávio Pinheiro Brisolla 9-75 Vila Universitária, Bauru, SP, Brazil.'}, {'ForeName': 'Maria Angélica Silvério', 'Initials': 'MAS', 'LastName': 'Agulhari', 'Affiliation': 'Department of Operative Dentistry, Endodontics and Dental Materials, Bauru School of Dentistry, University of São Paulo, Al. Dr Otávio Pinheiro Brisolla 9-75 Vila Universitária, Bauru, SP, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rios', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Al. Dr Otávio Pinheiro Brisolla 9-75, Bauru, SP, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Magalhães', 'Affiliation': 'Department of Biological Sciences, Bauru School of Dentistry, University of São Paulo, Al. Dr Octávio Pinheiro Brisolla 9-75, Bauru, SP, Brazil.'}, {'ForeName': 'Heitor Marques', 'Initials': 'HM', 'LastName': 'Honório', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Al. Dr Otávio Pinheiro Brisolla 9-75, Bauru, SP, Brazil.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Operative Dentistry, Endodontics and Dental Materials, Bauru School of Dentistry, University of São Paulo, Al. Dr Otávio Pinheiro Brisolla 9-75 Vila Universitária, Bauru, SP, Brazil. wang.linda@usp.br.'}]",Clinical oral investigations,['10.1007/s00784-019-03084-8']
673,30932750,Montmorency cherry supplement does not affect aerobic exercise performance in healthy men.,"Aim: To determine the effects of short-term Montmorency cherry (MC) supplementation upon exercise performance, total blood nitrate levels, muscle oxygenation, and slow-component [Formula: see text]O 2 kinetics. Methods: Twelve healthy male participants ingested a MC or placebo (PL) supplement in a randomized cross-over fashion over a six day period then cycled at a power output achieved at 70% of [Formula: see text]O 2 peak for a maximum of 30 minutes or until exhaustion. Near-Infrared Spectroscopy sensors were used to determine muscle oxygenation. Blood was collected one hour post-supplement consumption on day one, day six, and one hour post-exercise. Results: All results are presented as mean ± SEM. Blood nitrate (μM/L) levels were not different one hour post-ingestion (MC = 8.30 ± 2.15, PL = 8.18 ± 1.86), following six days of supplementation (MC = 9.14 ± 1.89, PL = 7.24 ± 1.75) or one hour post-exercise (MC = 9.63 ± 1.61, PL = 7.97 ± 1.92) for treatment F = 0.26, p = 0.62; for time F = 0.45, p = 0.64; or treatment by time interaction F = 2.28, p = 0.13. Muscle oxygenation was not different between treatments for the right or left vastus lateralis, F = 0.68, p = 0.81 nor was time to respiratory compensation point (minutes) (MC = 18.40 ± 1.48, PL = 17.16 ± 1.78) F = 0.52, p = 0.60. MC supplement ingestion does not alter blood nitrate levels. Conclusion: Short-term MC ingestion does not increase muscle oxygenation during cycling exercise nor does it change slow-component [Formula: see text]O 2 kinetics.",2020,Blood nitrate (μM/L) levels were not different one hour post-ingestion (MC = 8.30 ± ,"['Twelve healthy male participants ingested a', 'healthy men']","['MC or placebo (PL) supplement', 'Montmorency cherry supplement', 'short-term Montmorency cherry (MC) supplementation', 'Short-term MC ingestion']","['Muscle oxygenation', 'muscle oxygenation', 'blood nitrate levels', 'aerobic exercise performance', 'exercise performance, total blood nitrate levels, muscle oxygenation, and slow-component O 2 kinetics', 'Blood nitrate (μM/L) levels']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0330657', 'cui_str': 'Pie Cherry'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0005768'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",12.0,0.192469,Blood nitrate (μM/L) levels were not different one hour post-ingestion (MC = 8.30 ± ,"[{'ForeName': 'Greggory R', 'Initials': 'GR', 'LastName': 'Davis', 'Affiliation': 'University of Louisiana at Lafayette, Lafayette, LA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bellar', 'Affiliation': 'University of Louisiana at Lafayette, Lafayette, LA.'}]",International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition,['10.1024/0300-9831/a000575']
674,30908085,Gaze-Contingent Music Reward Therapy for Clinically Anxious 7- to 10-Year-Olds: An Open Multiple Baseline Feasibility Study.,"This multiple-baseline open pilot trial examined feasibility, compliance, acceptability, and preliminary indices of efficacy of Gaze-Contingent Music Reward Therapy (GC-MRT) for anxious 7- to 10-year-old children. GC-MRT is a novel therapy for anxiety disorders that relies on eye-tracking technology and operant conditioning principles to divert attention toward neutral over threat stimuli, with music serving as a reward. Using a multiple-baseline design, 12 children ( M age = 8.3 years, SD = .72, range = 7-10; 4 girls) with social anxiety disorder, generalized anxiety disorder, or separation anxiety disorder received 8 therapy sessions. Clinical status was determined via semistructured interviews and questionnaires. Patients were randomized to wait 1, 3, or 5 weeks between initial assessment and beginning of therapy. Self-reported anxiety was recorded weekly, and comprehensive clinical assessments were obtained pre- and posttreatment. All 12 patients completed the full course of GC-MRT within the allocated therapy period. Therapy credibility rates were moderate to high as reported by both children and parents. Clinician-rated anxiety levels remained consistent during baseline measurement and decreased significantly following treatment. Parent-reports also yielded significant reductions in child anxiety symptoms from pre- to posttreatment. However, child-reported anxiety did not change significantly. The results provide preliminary evidence for feasibility, acceptability, and efficacy of GC-MRT for young children with anxiety disorders. Efficacy should now be tested in randomized controlled trials.",2020,"The results provide preliminary evidence for feasibility, acceptability, and efficacy of GC-MRT for young children with anxiety disorders.","['young children with anxiety disorders', 'Clinically Anxious 7- to 10-Year-Olds', 'anxious 7- to 10-year-old children', '12 children (M age \xa0=\xa08.3\xa0years, SD\xa0=\xa0.72, range\xa0=\xa07-10; 4 girls) with social anxiety disorder, generalized anxiety disorder, or separation anxiety disorder received 8 therapy sessions']","['Gaze-Contingent Music Reward Therapy', 'GC-MRT', 'Gaze-Contingent Music Reward Therapy (GC-MRT']","['Self-reported anxiety', 'Therapy credibility rates', 'child anxiety symptoms', 'anxiety', 'Clinician-rated anxiety levels']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003477', 'cui_str': 'Separation Anxiety Disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}]",12.0,0.0304015,"The results provide preliminary evidence for feasibility, acceptability, and efficacy of GC-MRT for young children with anxiety disorders.","[{'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Linetzky', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kahn', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Lazarov', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Pine', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Bar-Haim', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2019.1573685']
675,31705201,Effects and side effects of a transdiagnostic bias modification intervention in a mixed sample with obsessive-compulsive and/or depressive symptoms-a randomized controlled trial.,"Obsessive-compulsive disorder (OCD) and major depression disorder (MDD) are underdiagnosed and undertreated mental disorders. Prior studies have verified the efficacy of the self-help manual My Metacognitive Training (myMCT) for patients with primary OCD. As depression and OCD share a number of (meta)cognitive biases and dysfunctional coping strategies, we examined the efficacy of myMCT in a mixed patient sample with OCD and/or depression. A total of 80 Italian-speaking individuals with symptoms of OCD and/or depression were randomized to either myMCT or to a waitlist control group (both groups had access to care as usual during the intervention). Post-assessment was carried out 6 weeks after inclusion. Scores on the Beck Depression Inventory-II scale (BDI-II) served as the primary outcome. Adverse effects were assessed with a newly devised self-report scale. Participants in the myMCT condition showed significant symptom improvement on the BDI-II scale at a medium to large effect size compared to the control group (using intention-to-treat and per protocol analyses). The intention-to-treat analyses yielded significant positive effects on the PHQ-9 scores and psychological as well as environmental well-being in favor of myMCT; for the OCI-R total score, group differences bordered significance in favor of the myMCT. The most prevalent adverse effects were feeling pressured by the suggested exercises or feeling bad due to not performing the exercises correctly. Our results indicate that the myMCT manual represents an effective program for patients with OCD as well as those with depressive symptoms in an Italian-speaking population. Adverse events due to unguided self-help deserve more attention in the future.",2020,Prior studies have verified the efficacy of the self-help manual My Metacognitive Training (myMCT) for patients with primary OCD.,"['patients with OCD', 'mixed sample with obsessive-compulsive and/or depressive symptoms', 'patients with primary OCD', '80 Italian-speaking individuals with symptoms of OCD and/or depression']","['myMCT', 'waitlist control group (both groups had access to care as usual during the intervention', 'myMCT manual', 'self-help manual My Metacognitive Training (myMCT', 'transdiagnostic bias modification intervention']","['Beck Depression Inventory-II scale (BDI-II', 'PHQ-9 scores and psychological', 'Obsessive-compulsive disorder (OCD', 'BDI-II scale', 'Adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0505289,Prior studies have verified the efficacy of the self-help manual My Metacognitive Training (myMCT) for patients with primary OCD.,"[{'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg Eppendorf, Hamburg, Germany. moritz@uke.de.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Bernardini', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Despina', 'Initials': 'D', 'LastName': 'Lion', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg Eppendorf, Hamburg, Germany.'}]",European archives of psychiatry and clinical neuroscience,['10.1007/s00406-019-01080-3']
676,30870245,Predictors of Exercise Training and Physical Activity Adherence in People Recently Hospitalized With Heart Failure: A BRIEF REPORT.,"PURPOSE
For individuals with heart failure (HF), frequent attendance at exercise training programs and meeting physical activity (PA) guidelines are significantly associated with improvements in 6-min walk distance. Despite the evidence, adherence to exercise interventions remains poor. The aim of this study was to identify predictors of these 2 variables in patients recently hospitalized with HF.
METHODS
In this substudy of the Exercise Joins Education: Combined Therapy to Improve Outcomes in Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk. Intervention group participants additionally undertook twice weekly supervised exercise training. Primary outcomes were frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines (150 min/wk of moderate intensity exercise) at 12 wk. Participant and clinical characteristics were analyzed using a logistic regression model to identify significant predictors of each outcome.
RESULTS
A total of 278 participants provided PA data and 140 contributed attendance data. New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03). Predictors of meeting PA guidelines at follow-up included new HF diagnosis (OR = 2.4; 95% CI, 1.2-4.8, P = .013), and being physically active at baseline (OR = 2.7; 95% CI, 1.3-5.6; P = .007). Gender, symptom severity, multimorbidity, and disability were not significantly associated with either outcome in multivariate analysis.
CONCLUSION
To improve adherence, specific strategies may be required for patients with decompensated HF and those physically inactive at time of referral.",2019,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","['278 participants provided PA data and 140 contributed attendance data', 'Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk', 'individuals with heart failure (HF', 'patients with decompensated HF and those physically inactive at time of referral', 'People Recently Hospitalized With Heart Failure']","['Exercise Training and Physical Activity Adherence', 'supervised exercise training']","['Gender, symptom severity, multimorbidity, and disability', 'frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines', 'frequent program attendance']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",278.0,0.0700865,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Adsett', 'Affiliation': ""Heart Support Service (Ms Adsett) and Departments of Physiotherapy (Ms Adsett) and Internal Medicine and Aged Care (Dr Mudge), Royal Brisbane and Women's Hospital, Brisbane, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Australia (Ms Adsett and Dr Morris); Menzies Health Institute, Queensland, Australia (Ms Adsett and Dr Morris); Metro North Hospital and Health Service, The Prince Charles Hospital, Allied Health Research Collaborative, Queensland, Australia (Dr Morris); and University of Queensland Faculty of Medicine, Brisbane, Queensland, Australia (Dr Mudge).""}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Mudge', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000407']
677,30887050,Reduction in acute kidney injury stage predicts survival in patients with type-1 hepatorenal syndrome.,"BACKGROUND
Hepatorenal syndrome type 1 (HRS-1), a form of acute kidney injury (AKI) in cirrhosis, has a median survival of days to weeks if untreated. The impact of reduction in AKI stage on overall survival in cirrhosis, independent of HRS reversal, is unclear.
METHODS
The Randomized, placEbo-controlled, double-blind study to confirm the reVERSal of HRS-1 with terlipressin study assessed terlipressin versus placebo, both with albumin, as treatment for HRS-1 for ≤14 days. Renal dysfunction severity was categorized by AKI stage at enrollment. Baseline patient characteristics were evaluated as predictors of AKI improvement using a multivariate model; the association between AKI stage reduction and 90-day survival was assessed using linear regression.
RESULTS
A total of 184 patients (terlipressin: n = 91; placebo: n = 93) with similar numbers in AKI Stages 1-3 (terlipressin/placebo, Stage 1: n = 25/26; Stage 2: n = 35/33; Stage 3: n = 31/34) were included. Predictors of AKI improvement were absence of alcoholic hepatitis, baseline serum creatinine and male gender. Overall survival was not significantly different across AKI stages (range 53-65%). In patients with no AKI worsening, 90-day survival was consistently better when AKI improved independent of HRS reversal, regardless of the initial AKI stage, with patients with Stage 1 at initial diagnosis achieving the greatest clinical benefit. A significant association was observed between AKI reduction and overall 90-day survival (P = 0.0022).
CONCLUSIONS
A reduction in AKI stage, independent of HRS reversal, was sufficient to improve overall survival in patients with HRS-1. The goal for HRS-1 treatment should be less stringent than absolute HRS reversal.",2020,"A reduction in AKI stage, independent of HRS reversal, was sufficient to improve overall survival in patients with HRS-1.","['184 patients (terlipressin: n\xa0=\xa091', '35/33; Stage 3: n\xa0=\xa031/34) were included', '25/26; Stage 2: n\xa0', 'Hepatorenal syndrome type 1', 'HRS-1 for ≤14\u2009days', 'patients with HRS-1', 'patients with type-1 hepatorenal syndrome']","['terlipressin versus placebo, both with albumin', 'placEbo', 'placebo: n\xa0=\xa093) with similar numbers in AKI Stages 1-3 (terlipressin/placebo, Stage 1: n\xa0']","['AKI stage reduction and 90-day survival', 'Renal dysfunction severity', 'Overall survival', 'alcoholic hepatitis, baseline serum creatinine and male gender', '90-day survival', 'AKI reduction and overall 90-day survival', 'overall survival']","[{'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0145185', 'cui_str': 'terlipressin'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0019212', 'cui_str': 'Hepatorenal Syndrome'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0145185', 'cui_str': 'terlipressin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}]","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019187', 'cui_str': 'Hepatitis, Alcoholic'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]",184.0,0.62913,"A reduction in AKI stage, independent of HRS reversal, was sufficient to improve overall survival in patients with HRS-1.","[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Boyer', 'Affiliation': 'Department of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Gastroenterology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Pappas', 'Affiliation': 'Scientific Affairs, Orphan Therapeutics, Lebanon, NJ, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Escalante', 'Affiliation': 'Biometrics, Mallinckrodt Pharmaceuticals, Bedminister, NJ, USA.'}, {'ForeName': 'Khurram', 'Initials': 'K', 'LastName': 'Jamil', 'Affiliation': 'Scientific Affairs, Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz048']
678,27189694,Measuring Medication Adherence in Pediatric Cancer: An Approach to Validation.,"Objective
This study described the prospective relationship between pharmacological and behavioral measures of 6-mercaptopurine (6MP) medication adherence in a multisite cohort of pediatric patients diagnosed with cancer ( N = 139).
Methods
Pharmacological measures (i.e., metabolite concentrations) assessed 6MP intake. Behavioral measures (e.g., electronic monitoring) described adherence patterns over time.
Results
Three metabolite profiles were identified across 15 months: one group demonstrated low levels of both metabolites (40.8%) consistent with nonadherence and/or suboptimal therapy; two other groups demonstrated metabolite clusters indicative of adequate adherence (59.2%). Those patients whose metabolite profile demonstrated low levels of both metabolites had consistently lower behavioral adherence rates.
Conclusions
To our knowledge, this was the first study to prospectively validate a pharmacological measure of medication adherence with a behavioral adherence measure in a relatively large sample of pediatric patients with cancer. Using multiple methods of adherence measurement could inform clinical care and target patients in need of intervention.",2017,"Those patients whose metabolite profile demonstrated low levels of both metabolites had consistently lower behavioral adherence rates.
","['pediatric patients diagnosed with cancer ( N \u2009=\u2009139', 'Pediatric Cancer', 'pediatric patients with cancer']",['6-mercaptopurine (6MP) medication adherence'],"['metabolite clusters indicative of adequate adherence', 'adherence patterns over time', 'low levels of both metabolites', 'behavioral adherence rates']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]","[{'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0236292,"Those patients whose metabolite profile demonstrated low levels of both metabolites had consistently lower behavioral adherence rates.
","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Rohan', 'Affiliation': 'Department of Psychology, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'Department of Pediatrics, University of Cincinnati School of Medicine, OH, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Alderfer', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, PA, USA.""}, {'ForeName': 'Crista', 'Initials': 'C', 'LastName': 'Wetherington Donewar', 'Affiliation': ""Center for Pediatric Psychiatry, Children's Medical Center Dallas, Texas, USA.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ewing', 'Affiliation': 'Department of Psychiatry, Western Psychiatric Institute and Clinic, Pittsburgh, PA, USA.'}, {'ForeName': 'Ernest R', 'Initials': 'ER', 'LastName': 'Katz', 'Affiliation': ""Division of General Pediatrics, Children's Hospital Los Angeles, CA, USA.""}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Muriel', 'Affiliation': ""Division of Psychosocial Oncology, Dana-Farber Cancer Institute and Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Vinks', 'Affiliation': 'Department of Pediatrics, University of Cincinnati School of Medicine, OH, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Drotar', 'Affiliation': 'Department of Psychology, University of Cincinnati, Cincinnati, OH, USA.'}]",Journal of pediatric psychology,['10.1093/jpepsy/jsw039']
679,30859220,Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I.,"AIMS
To assess the impact of MultiPoint™ Pacing (MPP)-programmed according to the physician's discretion-in non-responders to standard biventricular pacing after 6 months.
METHODS AND RESULTS
The study enrolled 1921 patients receiving a quadripolar cardiac resynchronization therapy (CRT) system capable of MPP™ therapy. A core laboratory assessed echocardiography at baseline and 6 months and defined volumetric non-response to biventricular pacing as <15% reduction in left ventricular end-systolic volume (LVESV). Clinical sites randomized patients classified as non-responders in a 1:1 ratio to receive MPP (236 patients) or continued biventricular pacing (231 patients) for an additional 6 months and evaluated rate of conversion to echocardiographic response. Baseline characteristics of both groups were comparable. No difference was observed in non-responder to responder conversion rate between MPP and biventricular pacing (31.8% and 33.8%, P = 0.72). In the MPP arm, 68 (29%) patients received MPP programmed with a wide LV electrode anatomical separation (≥30 mm) and shortest LV1-LV2 and LV2-RV timing delays (MPP-AS); 168 (71%) patients received MPP programmed with other settings (MPP-Other). MPP-AS elicited a significantly higher non-responder conversion rate compared to MPP-Other (45.6% vs. 26.2%, P = 0.006) and a trend in a higher conversion rate compared to biventricular pacing (45.6% vs. 33.8%, P = 0.10).
CONCLUSIONS
After 6 months, investigator-discretionary MPP programming did not significantly increase echocardiographic response compared to biventricular pacing in CRT non-responders.",2019,"After 6 months, investigator-discretionary MPP programming did not significantly increase echocardiographic response compared to biventricular pacing in CRT non-responders.","['236 patients) or', '1921 patients receiving a quadripolar cardiac resynchronization therapy (CRT) system capable of MPP™ therapy']","['MPP', 'Cardiac resynchronization therapy', 'MultiPoint™ Pacing (MPP)-programmed', 'continued biventricular pacing']","['echocardiographic response', 'conversion rate', 'non-responder to responder conversion rate between MPP and biventricular pacing', 'left ventricular end-systolic volume (LVESV', 'rate of conversion to echocardiographic response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0623363', 'cui_str': 'MPPS'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0623363', 'cui_str': 'MPPS'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2936372', 'cui_str': 'Atrio-Biventricular Pacing'}]","[{'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0623363', 'cui_str': 'MPPS'}, {'cui': 'C2936372', 'cui_str': 'Atrio-Biventricular Pacing'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}]",1921.0,0.0339216,"After 6 months, investigator-discretionary MPP programming did not significantly increase echocardiographic response compared to biventricular pacing in CRT non-responders.","[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leclercq', 'Affiliation': 'Université de Rennes I, CICIT 804, Rennes, CHU Pontchaillou, Rennes, France.'}, {'ForeName': 'Haran', 'Initials': 'H', 'LastName': 'Burri', 'Affiliation': 'University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Curnis', 'Affiliation': 'Università degli Studi di Brescia, Brescia, Italy.'}, {'ForeName': 'Peter Paul', 'Initials': 'PP', 'LastName': 'Delnoy', 'Affiliation': 'Isala Klinieken, Zwolle, The Netherlands.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Rinaldi', 'Affiliation': ""King's College, London, UK.""}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Sperzel', 'Affiliation': 'Kerckhoff Klinik, Bad Nauheim, Germany.'}, {'ForeName': 'Kwangdeok', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Abbott, Plano, TX, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Calò', 'Affiliation': 'Policlinico Casilino, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Vicentini', 'Affiliation': 'Casa di Cura Dott, Pederzoli, Italy.'}, {'ForeName': 'Joaquin Fernandez', 'Initials': 'JF', 'LastName': 'Concha', 'Affiliation': 'Hospital Universitario Infanta Cristina, Spain.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Thibault', 'Affiliation': 'Université de Montréal, Montreal, Canada.'}]",European heart journal,['10.1093/eurheartj/ehz109']
680,30843038,QT as a predictor of recurrence after atrial fibrillation ablation and the impact of amiodarone: results from the placebo-controlled AMIO-CAT trial.,"AIMS
Prolonged corrected QT interval (QTc) might be associated with arrhythmia recurrence after atrial fibrillation (AF) ablation. The effect of short-term amiodarone in this setting remains unknown. This study seeks to quantify short-term amiodarone's impact on QTc, and to investigate QTc and amiodarone treatment as predictors of recurrence of arrhythmia after ablation.
METHODS AND RESULTS
The Short-term AMIOdarone treatment after CATheter ablation for atrial fibrillation (AMIO-CAT) trial randomized patients to 8 weeks of oral amiodarone or placebo following AF ablation. Scheduled and symptom-driven 12-lead electrocardiography and 3-day Holter-monitorings were performed. The endpoint was atrial fibrillation, atrial flutter or atrial tachycardia (AF/AT) lasting >30 s. The cut-off for prolonged QTc was 450 ms for men and 460 ms for women. A total of 212 patients were included, of which 108 were randomized to amiodarone and 104 to placebo. From baseline to 1 month QTc in the amiodarone group increased by 27 (±30) ms, while at 6 months QTc had normalized. After 3-months of blanking, new AF/AT recurrence was detected in 63% of patients with prolonged QTc vs. 41% of patients with normal QTc at baseline, and in multivariate Cox regression, prolonged QTc was associated with AF/AT recurrence [hazard ratio (HR) 2.19, P = 0.023]. Among patients with baseline QTc below median, amiodarone treatment decreased the rate of AF/AT recurrences (HR 0.43, P = 0.008).
CONCLUSIONS
Amiodarone increased QTc with 27 ms compared to placebo, and this effect decreased rapidly after drug discontinuation. Prolonged QTc at baseline independently predicted AF/AT recurrence, and baseline QTc identified patients who would possibly benefit from short-term amiodarone following ablation.",2019,"After 3-months of blanking, new AF/AT recurrence was detected in 63% of patients with prolonged QTc vs. 41% of patients with normal QTc at baseline, and in multivariate Cox regression, prolonged QTc was associated with AF/AT recurrence [hazard ratio (HR) 2.19, P = 0.023].","['following AF ablation', 'A total of 212 patients']","['Amiodarone', 'placebo', 'amiodarone or placebo', 'amiodarone', 'AMIOdarone', 'QT', 'AIMS\n\n\nProlonged corrected QT interval (QTc']","['atrial fibrillation, atrial flutter or atrial tachycardia (AF/AT) lasting ', 'rate of AF/AT recurrences', 'QTc', 'new AF/AT recurrence', 'Prolonged QTc']","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0860814', 'cui_str': 'QTc'}]","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Auricular Flutter'}, {'cui': 'C0546959', 'cui_str': 'Atrial tachycardia (disorder)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]",212.0,0.144308,"After 3-months of blanking, new AF/AT recurrence was detected in 63% of patients with prolonged QTc vs. 41% of patients with normal QTc at baseline, and in multivariate Cox regression, prolonged QTc was associated with AF/AT recurrence [hazard ratio (HR) 2.19, P = 0.023].","[{'ForeName': 'Søren Zöga', 'Initials': 'SZ', 'LastName': 'Diederichsen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, København, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Darkner', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, København, Denmark.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, København, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Johannessen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Pehrson', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, København, Denmark.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Jesper Hastrup', 'Initials': 'JH', 'LastName': 'Svendsen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, København, Denmark.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz028']
681,29941389,Antimicrobial Lubricant Did Not Reduce Infection Rate in Transrectal Biopsy Patients in a Large Randomized Trial Due to Low Complication Rates.,"BACKGROUND
Transrectal prostate biopsy (pbx) is the most frequent outpatient procedure in the urological field. Septic complications are a major health issue.
OBJECTIVE
To evaluate complication rates with or without an antimicrobial lubricant.
DESIGN, SETTING, AND PARTICIPANTS
A total of 1000 patients received pbx between 2013 and 2015. Information about complications was collected by a 3-wk questionnaire. Return rate was 73.2% (n=732).
INTERVENTION
Randomization for pbx with the instillation of an antimicrobial lubricant (intervention group, n=385) or the standard lubricant (control group, n=347) was performed.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Multivariable analyses assessed the association between infectious complications at biopsy and use of an antimicrobial lubricant, International Prostate Symptom Score (IPSS), history of urogenitourinary infections, and several other confounders.
RESULTS AND LIMITATIONS
The use of an antimicrobial lubricant did not reduce infection rate. Overall complication rate was very low. Of all patients, 69.3% described the procedure as pain free. Fever ≥38.5°C was reported in overall 1.9% of patients. Urinary retention with catheterization occurred in 3.1%. Most common complications were hematospermia (47.4%), macrohematuria (23.8%), and rectal bleeding (7.4%). Readmission rate was 1% (n=7). In multivariable analyses, IPSS and previous infectious complications were associated with a higher risk of infectious complications. Our results stem from a large German single center and therefore are limited to this patient group.
CONCLUSIONS
No significant reduction was shown in infectious complications in the intervention group with the antimicrobial agent. Low incidence of those complications may be the underlying cause. Severe morbidity at pbx is uncommon. Specifically, the rate of infection was very low.
PATIENT SUMMARY
Severe complications at prostate biopsy are rare. Among participants, 69.3% had no pain. Fever was rare (1.9% of patients). Voiding issues with catheterization occurred in 3.1%. Most common complications were blood in the semen (47.4%), urine (23.8%), or stool (7.4%). Men with voiding issues or previous infectious complications had a higher risk of infectious complications.",2019,No significant reduction was shown in infectious complications in the intervention group with the antimicrobial agent.,"['Transrectal Biopsy Patients', '1000 patients received pbx between 2013 and 2015']","['Transrectal prostate biopsy (pbx', 'Antimicrobial Lubricant', 'Randomization for pbx with the instillation of an antimicrobial lubricant (intervention group, n=385) or the standard lubricant (control group, n=347) was performed', 'antimicrobial lubricant']","['rate of infection', 'rectal bleeding', 'Voiding issues with catheterization', 'complication rates', 'infection rate', 'Severe complications', 'Readmission rate', 'Urinary retention with catheterization', 'infectious complications at biopsy and use of an antimicrobial lubricant, International Prostate Symptom Score (IPSS), history of urogenitourinary infections, and several other confounders', 'Septic complications', 'Return rate', 'Overall complication rate', 'infectious complications', 'Severe morbidity', 'Fever', 'Infection Rate']","[{'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}]","[{'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0267596', 'cui_str': 'Rectal hemorrhage (disorder)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}]",1000.0,0.128082,No significant reduction was shown in infectious complications in the intervention group with the antimicrobial agent.,"[{'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Salomon', 'Affiliation': 'Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Prues', 'Affiliation': 'Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Saul', 'Affiliation': 'Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Budäus', 'Affiliation': 'Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Tilki', 'Affiliation': 'Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Department of Urology, University Medical Center, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haferkamp', 'Affiliation': 'Department of Urology, University Medical Center, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Graefen', 'Affiliation': 'Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Boehm', 'Affiliation': 'Martini-Clinic, Prostate Cancer Centre, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Urology, University Medical Center, Johannes Gutenberg University, Mainz, Germany. Electronic address: katharina.boehm@unimedizin-mainz.de.'}]",European urology focus,['10.1016/j.euf.2018.06.005']
682,30720503,"Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial.","MINI: Question: Is the Fundamentals of Robotic Surgery (FRS) proficiency-based progression curriculum effective for teaching basic robotic surgery skills?
FINDINGS
In an international multi-institutional, multispecialty, blinded, randomized control trial, implementation of the FRS skills curriculum using various simulation platforms led to improved performance of surgical trainees on a transfer test compared with controls.Meaning: The FRS is an effective simulation-based course for training to proficiency on basic robotic surgery skills before surgeons apply those skills clinically.
OBJECTIVE
To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform.
SUMMARY BACKGROUND DATA
There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills.
METHODS
Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n = 29), dV-Trainer (n = 30), and DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores.
RESULTS
All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67).
CONCLUSIONS
We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically.",2019,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"['FRS) Skills Curriculum', 'Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016', '12 international American College of Surgeons (ACS']","['MINI', 'Robotic Surgery', 'robotic surgery (FRS) skills curriculum', 'DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula', 'FRS', 'dV-Trainer']","['GEARS ratings', 'cognitive test scores, GEARS ratings, and robot familiarity checklist scores', 'participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test']","[{'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0010478', 'cui_str': 'Curriculum'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0005595', 'cui_str': 'Aves'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",,0.168174,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Satava', 'Affiliation': 'Department of Surgery, University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Stefanidis', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Levy', 'Affiliation': 'Department of Ob/Gyn, Drexel University College of Medicine, Institute of Surgical Excellence, Philadelphia, PA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Florida Hospital Nicholson Center, University of Central Florida College of Medicine, Celebration, FL.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Martin', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Monfared', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Lava R', 'Initials': 'LR', 'LastName': 'Timsina', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Ara Wardkes', 'Initials': 'AW', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery, St. Mary's Hospital, Imperial College, London, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moglia', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Brand', 'Affiliation': 'Andersen Simulation Center, Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Dorin', 'Affiliation': 'Center for Education, Simulation and Innovation, Hartford Hospital, Hartford, CT.'}, {'ForeName': 'Kristoffel R', 'Initials': 'KR', 'LastName': 'Dumon', 'Affiliation': 'Penn Medicine Clinical Simulation Center, Philadelphia, PA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Francone', 'Affiliation': 'Department of Colon and Rectal Surgery, Lahey Health and Medical Center, Burlington, MA.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Alvin C', 'Initials': 'AC', 'LastName': 'Goh', 'Affiliation': 'Houston Methodist Hospital, Methodist Institute for Technology, Innovation, and Education, Houston, TX.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Marcet', 'Affiliation': 'USF Health Center for Advanced Medical Learning and Simulation, Tampa, FL.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Martino', 'Affiliation': 'Lehigh Valley Health Network, Allentown, PA.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Sudan', 'Affiliation': 'Department of Surgery, Surgical Education and Activities Lab, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Vale', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': 'Technology Enhanced Learning, ASSERT Centre, College of Medicine and Health, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland.'}]",Annals of surgery,['10.1097/SLA.0000000000003220']
683,30796528,Mental health in refugees and asylum seekers (MEHIRA): study design and methodology of a prospective multicentre randomized controlled trail investigating the effects of a stepped and collaborative care model.,"The sudden arrival of culturally diverse asylum seekers and refugees into Germany has created a strong demand for recognizing and appropriately treating those suffering from mental health issues. Due to many systemic, organizational, cultural and socio-linguistic barriers, psychiatric treatment of refugees is posing a major challenge to Germany's mental health care system. Thus, there is a need for alternative models that allow for increased access to adequate, effective and efficient culturally sensitive mental health care services. Here, we describe the Mental Health in Refugees and Asylum Seekers (MEHIRA) project, a multicentre randomized controlled trial investigating a stepped collaborative care model (SCCM) for providing mental health treatment in this vulnerable population. The proposed SCCM aims to decrease the aforementioned barriers. Adult and adolescent participants will be screened for depressive symptoms and matched to appropriate psychological interventions, including group-level interventions (START intervention, Empowerment/Gender-sensitive/Peer to peer), and other innovative, digital treatment approaches (Smartphone application). The therapeutic effect of the SCCM will be compared to TAU (treatment-as-usual). All interventions have been designed to be culturally sensitive, and offered in two different languages: Arabic and Farsi. The outcome of this study may contribute significantly to future clinical and legal guidelines in developing parallel and efficient new structures of treatment. Collected data will inform primary and secondary mental health care providers with recommendations concerning the design and implementation of effective treatment models and programmes. Guidelines and recommendations may also potentially be adopted by other host countries, developing countries and also in humanitarian aid programmes.",2020,"Here, we describe the Mental Health in Refugees and Asylum Seekers (MEHIRA) project, a multicentre randomized controlled trial investigating a stepped collaborative care model (SCCM) for providing mental health treatment in this vulnerable population.",['Adult and adolescent participants'],"['SCCM', 'group-level interventions (START intervention, Empowerment/Gender-sensitive/Peer to peer), and other innovative, digital treatment approaches (Smartphone application', 'stepped collaborative care model (SCCM']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",[],,0.0451037,"Here, we describe the Mental Health in Refugees and Asylum Seekers (MEHIRA) project, a multicentre randomized controlled trial investigating a stepped collaborative care model (SCCM) for providing mental health treatment in this vulnerable population.","[{'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Böge', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Karnouk', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schneider', 'Affiliation': 'Department of Psychiatry and Psychotherapy, RWTH Aachen University and JARA-Institute Brain Structure Function Relationship (INM 10), Research Center Jülich and RWTH, Aachen, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Habel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, RWTH Aachen University and JARA-Institute Brain Structure Function Relationship (INM 10), Research Center Jülich and RWTH, Aachen, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Banaschewski', 'Affiliation': 'Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Meyer-Lindenberg', 'Affiliation': 'Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Hans Joachim', 'Initials': 'HJ', 'LastName': 'Salize', 'Affiliation': 'Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Kamp-Becker', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Psychosomatics and Psychotherapy, Faculty of Human Medicine, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital LMU, Munich, Germany.'}, {'ForeName': 'Alkomiet', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital LMU, Munich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Falkai', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital LMU, Munich, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Rapp', 'Affiliation': 'Department of Social and Preventive Medicine, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Plener', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stamm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin, Campus Mitte, Berlin, Germany.'}, {'ForeName': 'Nehal', 'Initials': 'N', 'LastName': 'Elnahrawy', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Universitätsmedizin Mainz, Mainz, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Lieb', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Universitätsmedizin Mainz, Mainz, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Heinz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin, Campus Mitte, Berlin, Germany.'}, {'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Bajbouj', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany. malek.bajbouj@charite.de.'}]",European archives of psychiatry and clinical neuroscience,['10.1007/s00406-019-00991-5']
684,31736187,Stress-related suppression of peripheral cytokines predicts future relapse in alcohol-dependent individuals with and without subclinical depression.,"Chronic alcohol abuse and depressive symptoms are both associated with peripheral cytokine changes. Despite this, cytokine adaptations have not been assessed in co-morbid populations or prospectively as predictors of relapse. We examine cytokine responses to stress in alcohol-dependent individuals and social drinkers, both with and without subclinical depression. We also examine the potential link between cytokine adaptations in response to stress and prospective alcohol relapse risk. Thirty-three, alcohol-dependent individuals (21 with and 12 without high depressive symptoms) and 37 controls (16 with and 21 without high depressive symptoms) were exposed to two 5-minute personalized guided imagery conditions (stress and neutral) across consecutive days in a randomized and counterbalanced order. Alcohol craving and serum measures of tumor necrosis factor alpha (TNFα), tumor necrosis factor receptor 1 (TNFR1), interleukin-6 (IL-6), and interleukin-1 receptor antagonist (IL-1ra) were collected prior to and following imagery exposure. Following treatment discharge, follow-up interviews were conducted over 90 days to assess relapse. Dampened IL-1ra and IL-6 in response to stress was observed as a function of alcohol dependence and not moderated by depressive symptoms. Lower levels of IL-6 following stress also predicted greater drinking days following treatment. Conversely, high depressive symptomatology was associated solely with pro-inflammatory adaptations. Stress-related suppression of TNFα predicted drinking severity only in alcohol-dependent individuals with subclinical depression, and suppressed TNFR1 following stress was only seen in individuals with subclinical depression. Stress-induced suppression of pro-inflammatory TNF markers may indicate a risk factor for alcohol-dependent individuals with co-occurring depressive symptoms.",2020,"Alcohol craving and serum measures of tumor necrosis factor alpha (TNFα), tumor necrosis factor receptor 1 (TNFR1), interleukin-6 (IL-6), and interleukin-1 receptor antagonist (IL-1ra) were collected prior to and following imagery exposure.","['alcohol-dependent individuals with and without subclinical depression', 'Thirty-three, alcohol-dependent individuals (21 with and 12 without high depressive symptoms) and 37 controls (16 with and 21 without high depressive symptoms', 'alcohol-dependent individuals and social drinkers, both with and without subclinical depression']",['5-minute personalized guided imagery conditions (stress and neutral'],"['Chronic alcohol abuse and depressive symptoms', 'Alcohol craving and serum measures of tumor necrosis factor alpha (TNFα), tumor necrosis factor receptor 1 (TNFR1), interleukin-6 (IL-6), and interleukin-1 receptor antagonist (IL-1ra']","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0337676', 'cui_str': 'Social drinker (finding)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0077503', 'cui_str': 'TNF Receptors'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2317059', 'cui_str': 'Interleukin 1 receptor antagonist product'}, {'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}]",,0.0329056,"Alcohol craving and serum measures of tumor necrosis factor alpha (TNFα), tumor necrosis factor receptor 1 (TNFR1), interleukin-6 (IL-6), and interleukin-1 receptor antagonist (IL-1ra) were collected prior to and following imagery exposure.","[{'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Fox', 'Affiliation': 'Department of Psychiatry, School of Medicine, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Verica', 'Initials': 'V', 'LastName': 'Milivojevic', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'MacDougall', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'LaVallee', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Simpson', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Gustavo A', 'Initials': 'GA', 'LastName': 'Angarita', 'Affiliation': 'Clinical Neuroscience Research Unit, The Connecticut Mental Health Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'The Yale Stress Center, Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}]",Addiction biology,['10.1111/adb.12832']
685,31685792,Effect of dapagliflozin on obstructive sleep apnea in patients with type 2 diabetes: a preliminary study.,"OBJECTIVE
The aim of this case-control study was to assess the efficacy of dapagliflozin combined with metformin for type-2 diabetes mellitus (T2DM) with obstructive sleep apnea hypopnea syndrome (OSAHS).
METHODS
A total of 36 patients with newly-diagnosed T2DM and OSAHS were randomized divided into two groups. Eighteen OSAHS patients with T2DM, who were treated with dapagliflozin and metformin, were assigned as the dapagliflozin group. These patients were given dapagliflozin and metformin for 24 weeks between February 2017 and February 2018. Another 18 OSAHS patients with T2DM, who were treated with glimepiride and metformin for 24 weeks, were assigned as the control group. Fasting plasma glucose (FPG) level, postprandial blood glucose (PPG), hemoglobin A1C (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR), blood lipids, body mass index (BMI), blood pressure, apnea-hypopnea index (AHI), minimum oxygen saturation (LSpO 2 ), and Epworth Somnolence Scale (ESS) score were measured before and at 24 weeks after the initiation of treatment.
RESULTS
In the dapagliflozin group, triglyceride (TG), systolic pressure (SBP) and diastolic pressure (DBP) significantly decreased following treatment, while high-density lipoprotein cholesterol (HDL-C) significantly increased (P < 0.05). Furthermore, a reduction in AHI, an increase in LSpO 2 and a decrease in ESS score were observed in the dapagliflozin group (P < 0.05), but not in the control group. Moreover, blood glucose, HbA1c, HOMA-IR, and BMI significantly decreased in these two groups, and the decrease was more significant in the dapagliflozin group.
CONCLUSION
These present results indicate that dapagliflozin can significantly reduce glucose, BMI, blood pressure and AHI, and improve hypoxemia during sleep and excessive daytime sleepiness, which thereby has potential as an effective treatment approach for OSAHS.",2019,"Moreover, blood glucose, HbA1c, HOMA-IR, and BMI significantly decreased in these two groups, and the decrease was more significant in the dapagliflozin group.
","['for 24 weeks between February 2017 and February 2018', 'Eighteen OSAHS patients with T2DM', '36 patients with newly-diagnosed T2DM and OSAHS', 'type-2 diabetes mellitus (T2DM) with obstructive sleep apnea hypopnea syndrome (OSAHS', 'patients with type 2 diabetes', 'Another 18 OSAHS patients with T2DM']","['dapagliflozin', 'dapagliflozin combined with metformin', 'dapagliflozin and metformin', 'glimepiride and metformin']","['ESS score', 'glucose, BMI, blood pressure and AHI, and improve hypoxemia during sleep and excessive daytime sleepiness', 'obstructive sleep apnea', 'blood glucose, HbA1c, HOMA-IR, and BMI', 'Fasting plasma glucose (FPG) level, postprandial blood glucose (PPG), hemoglobin A1C (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR), blood lipids, body mass index (BMI), blood pressure, apnea-hypopnea index (AHI), minimum oxygen saturation (LSpO 2 ), and Epworth Somnolence Scale (ESS) score', 'triglyceride (TG), systolic pressure (SBP) and diastolic pressure (DBP', 'high-density lipoprotein cholesterol (HDL-C']","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C4285910', 'cui_str': 'Obstructive sleep apnea hypopnea syndrome'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0587116', 'cui_str': 'During sleep (qualifier value)'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic Pressure'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}]",,0.0118343,"Moreover, blood glucose, HbA1c, HOMA-IR, and BMI significantly decreased in these two groups, and the decrease was more significant in the dapagliflozin group.
","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""Department of Endocrinology, The Fifth People's Hospital of Chengdu, 611130, Chengdu, P.R. China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': ""Center of Diabetes Mellitus, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, 610072, Chengdu, P. R. China. sunqin1947@163.com.""}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Bai', 'Affiliation': ""Department of Respiratory, The Fifth People's Hospital of Chengdu, 611130, Chengdu, P.R. China.""}, {'ForeName': 'Yun-Fan', 'Initials': 'YF', 'LastName': 'Zhou', 'Affiliation': ""Department of Endocrinology, The Third People's Hospital of Chengdu, 610000, Chengdu, P.R. China.""}, {'ForeName': 'Qiong-Lan', 'Initials': 'QL', 'LastName': 'Zhou', 'Affiliation': ""Department of Endocrinology, People's Hospital of Yilong County, 637676, Yilong, P.R. China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Center of Diabetes Mellitus, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, 610072, Chengdu, P. R. China. zhangmcd@163.com.""}]",Nutrition & diabetes,['10.1038/s41387-019-0098-5']
686,31672143,A clinical trial of enteral Levetiracetam for acute seizures in pediatric cerebral malaria.,"BACKGROUND
Acute seizures are common in pediatric cerebral malaria (CM), but usual care with phenobarbital risks respiratory suppression. We undertook studies of enteral levetiracetam (eLVT) to evaluate pharmacokinetics (PK), safety and efficacy including an open-label, randomized controlled trial (RCT) comparing eLVT to phenobarbital.
METHODS
Children 24-83 months old with CM were enrolled in an eLVT dose-finding study starting with standard dose (40 mg/kg load, then 30 mg/kg Q12 hours) titrated upward until seizure freedom was attained in 75% of subjects. The RCT that followed randomized children to eLVT vs. phenobarbital for acute seizures and compared the groups on minutes with seizures based upon continuous electroencephalogram. Due to safety concerns, midway through the study children allocated to phenobarbital received the drug only if they continued to have seizures (either clinically or electrographically) after benzodiazepine treatment. Secondary outcomes were treatment failure requiring cross over, coma duration and neurologic sequelae at discharge. PK and safety assessments were also undertaken.
RESULTS
Among 30 comatose CM children, eLVT was rapidly absorbed and well-tolerated. eLVT clearance was lower in patients with higher admission serum creatinine (SCr), but overall PK parameters were similar to prior pediatric PK studies. Within 4 h of the first dose, 90% reached therapeutic levels (> 20 μg/mL) and all were above 6 μg/mL. 7/7 children achieved seizure freedom on the initial eLVT dose. Comparing 23 eLVT to 21 phenobarbital patients among whom 15/21 received phenobarbital, no differences were seen for minutes with seizure, seizure freedom, coma duration, neurologic sequelae or death, but eLVT was safer (p = 0.019). Phenobarbital was discontinued in 3/15 due to respiratory side effects.
CONCLUSION
Enteral LVT offers an affordable option for seizure control in pediatric CM and is safer than phenobarbital.
TRIAL REGISTRATION
NCT01660672 . NCT01982812 .",2019,"eLVT clearance was lower in patients with higher admission serum creatinine (SCr), but overall PK parameters were similar to prior pediatric PK studies.","['Children 24-83\u2009months old with CM were enrolled in an', '30 comatose CM children', 'acute seizures in pediatric cerebral malaria']","['Phenobarbital', 'benzodiazepine', 'Enteral LVT', 'eLVT vs. phenobarbital', 'eLVT', 'enteral levetiracetam (eLVT', 'enteral Levetiracetam']","['therapeutic levels', 'eLVT clearance', 'minutes with seizure, seizure freedom, coma duration, neurologic sequelae or death', 'treatment failure requiring cross over, coma duration and neurologic sequelae at discharge', 'pharmacokinetics (PK), safety and efficacy', 'seizure freedom']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0024534', 'cui_str': 'Malaria, Cerebral'}]","[{'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0243088', 'cui_str': 'sequelae'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0162643'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.178529,"eLVT clearance was lower in patients with higher admission serum creatinine (SCr), but overall PK parameters were similar to prior pediatric PK studies.","[{'ForeName': 'Gretchen L', 'Initials': 'GL', 'LastName': 'Birbeck', 'Affiliation': 'Department of Neurology, University of Rochester, 265 Crittenden Blvd, Rochester, NY, 14642, USA. gretchen_birbeck@urmc.rochester.edu.'}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Herman', 'Affiliation': 'Department of Neurology, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'University of California San Diego, Center for Research in Paediatric and Developmental Pharmacology, La Jolla, CA, USA.'}, {'ForeName': 'Fraction K', 'Initials': 'FK', 'LastName': 'Dzinjalamala', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Samah G', 'Initials': 'SG', 'LastName': 'Abdel Baki', 'Affiliation': 'Bio-Signal Group Co., Acton, MA, USA.'}, {'ForeName': 'Macpherson', 'Initials': 'M', 'LastName': 'Mallewa', 'Affiliation': 'Department of Paediatrics, Queen Elizabeth Central Hospital, Blantyre, Malawi.'}, {'ForeName': 'Neema M', 'Initials': 'NM', 'LastName': 'Toto', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'Postels', 'Affiliation': ""Department of Neurology, Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Gardiner', 'Affiliation': 'Department of Epidemiology & Biostatistics, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Terrie E', 'Initials': 'TE', 'LastName': 'Taylor', 'Affiliation': 'Blantyre Malaria Project, Blantyre, Malawi.'}, {'ForeName': 'Karl B', 'Initials': 'KB', 'LastName': 'Seydel', 'Affiliation': 'Blantyre Malaria Project, Blantyre, Malawi.'}]",BMC pediatrics,['10.1186/s12887-019-1766-2']
687,29897562,"Post-chemoradiation volumetric response predicts survival in newly diagnosed glioblastoma treated with radiation, temozolomide, and bevacizumab or placebo.","Background
In the current study we used contrast-enhanced T1 subtraction maps to test whether early changes in enhancing tumor volume are prognostic for overall survival (OS) in newly diagnosed glioblastoma (GBM) patients treated with chemoradiation with or without bevacizumab (BV).
Methods
Seven hundred ninety-eight patients (404 BV and 394 placebo) with newly diagnosed GBM in the AVAglio trial (NCT00943826) had baseline MRI scans available, while 337 BV-treated and 269 placebo-treated patients had >4 MRI scans for response evaluation. The volume of contrast-enhancing tumor was quantified and used for subsequent analyses.
Results
A decrease in tumor volume during chemoradiation was associated with a longer OS in the placebo group (hazard ratio [HR] = 1.578, P < 0.0001) but not BV-treated group (HR = 1.135, P = 0.4889). Results showed a higher OS in patients on the placebo arm with a sustained decrease in tumor volume using a post-chemoradiation baseline (HR = 1.692, P = 0.0005), and a trend toward longer OS was seen in BV-treated patients (HR = 1.264, P = 0.0724). Multivariable Cox regression confirmed that sustained response or stable disease was prognostic for OS (HR = 0.7509, P = 0.0127) when accounting for age (P = 0.0002), KPS (P = 0.1516), postsurgical tumor volume (P < 0.0001), O6-methylguanine-DNA methyltransferase status (P < 0.0001), and treatment type (P = 0.7637) using the post-chemoradiation baseline.
Conclusions
The post-chemoradiation timepoint is a better baseline for evaluating efficacy in newly diagnosed GBM. Early progression during the maintenance phase is consequential in predicting OS, supporting the use of progression-free survival rates as a meaningful surrogate for GBM.",2018,"A decrease in tumor volume during chemoradiation was associated with a longer OS in the placebo group (hazard ratio [HR] = 1.578, P < 0.0001) but not BV-treated group (HR = 1.135, P = 0.4889).","['newly diagnosed glioblastoma (GBM) patients treated with chemoradiation with or without bevacizumab (BV', 'Methods\n\n\nSeven hundred ninety-eight patients (404 BV and 394 placebo) with newly diagnosed GBM in the AVAglio trial (NCT00943826) had baseline MRI scans available, while 337 BV-treated and 269 placebo-treated patients had >4 MRI scans for response evaluation']","['radiation, temozolomide, and bevacizumab or placebo', 'placebo']","['longer OS', 'postsurgical tumor volume', 'tumor volume', 'O6-methylguanine-DNA methyltransferase status', 'volume of contrast-enhancing tumor']","[{'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0917711', 'cui_str': 'MRI Scans'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C0069225', 'cui_str': '6-methoxyguanine'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C4521687', 'cui_str': 'Methyltransferase (disposition)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]",798.0,0.163251,"A decrease in tumor volume during chemoradiation was associated with a longer OS in the placebo group (hazard ratio [HR] = 1.578, P < 0.0001) but not BV-treated group (HR = 1.135, P = 0.4889).","[{'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Ellingson', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Abrey', 'Affiliation': 'F. Hoffman-La Roche, Ltd.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Garcia', 'Affiliation': 'F. Hoffman-La Roche, Ltd.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chinot', 'Affiliation': 'Aix-Marseille University, AP-HM, Service de Neuro-Oncologie, CHU Timone, Marseille, France.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Clinical Cooperation Unit Neuro-oncology, German Cancer Consortium, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Saran', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, Sutton, UK.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Nishikawa', 'Affiliation': 'Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Henriksson', 'Affiliation': 'Regional Cancer Center Stockholm, Stockholm, Sweden and Umeå University, Umeå, Sweden.'}, {'ForeName': 'Warren P', 'Initials': 'WP', 'LastName': 'Mason', 'Affiliation': 'Princess Margaret Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Harris', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Leu', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Davis C', 'Initials': 'DC', 'LastName': 'Woodworth', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Arnav', 'Initials': 'A', 'LastName': 'Mehta', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Raymond', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Ararat', 'Initials': 'A', 'LastName': 'Chakhoyan', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Whitney B', 'Initials': 'WB', 'LastName': 'Pope', 'Affiliation': 'Department of Radiological Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Cloughesy', 'Affiliation': 'UCLA Brain Research Institute, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}]",Neuro-oncology,['10.1093/neuonc/noy064']
688,32407654,Caffeine increases peripheral fatigue in low- but not in high-performing cyclists.,"The influence of cyclists' performance levels on caffeine-induced increases in neuromuscular fatigue after a 4-km cycling time trial (TT) was investigated. Nineteen cyclists performed a 4-km cycling TT 1 h after ingesting caffeine (5 mg·kg -1 ) or placebo (cellulose). Changes from baseline to after exercise in voluntary activation (VA) and potentiated 1 Hz force twitch ( Q tw,pot ) were used as markers of central and peripheral fatigue, respectively. Participants were classified as ""high performing"" (HP, n = 8) or ""low performing"" (LP, n = 8) in accordance with their performance in a placebo trial. Compared with placebo, caffeine increased the power, anaerobic mechanical power, and anaerobic work, reducing the time to complete the trial in both groups ( p < 0.05). There was a group versus supplement and a group versus supplement versus trial interaction for Q tw,pot , in which the postexercise reduction was greater after caffeine compared with placebo in the LP group ( Q tw,pot = -34% ± 17% vs. -21% ± 11%, p = 0.02) but not in the HP group ( Q tw,pot = -22% ± 8% vs. -23% ± 10%, p = 0.64). There was no effect of caffeine on VA, but there was a group versus trial interaction with lower postexercise values in the LP group than in the HP group ( p = 0.03). Caffeine-induced improvement in 4-km cycling TT performance seems to come at the expense of greater locomotor muscle fatigue in LP but not in HP cyclists. Novelty Caffeine improves exercise performance at the expense of a greater end-exercise peripheral fatigue in low-performing athletes. Caffeine-induced improvement in exercise performance does not affect end-exercise peripheral fatigue in high-performing athletes. High-performing athletes seem to have augmented tolerance to central fatigue during a high-intensity time trial.",2020,"Compared with placebo, caffeine increased the power, the anaerobic mechanical power and the anaerobic work, reducing the time to complete the trial for both groups (p<0.05).",['Nineteen cyclists'],"['High', 'caffeine', 'Caffeine', 'placebo in LP', 'caffeine (5 mg‧kg-1) or placebo (cellulose', 'placebo, caffeine']","['4-km cycling TT performance', 'Peripheral Fatigue', 'locomotor muscle fatigue', 'anaerobic mechanical power and the anaerobic work', 'neuromuscular fatigue', 'exercise performance']","[{'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",19.0,0.100991,"Compared with placebo, caffeine increased the power, the anaerobic mechanical power and the anaerobic work, reducing the time to complete the trial for both groups (p<0.05).","[{'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Santos', 'Affiliation': 'Human Performance Research Group, Academic Department of Physical Education, Federal University of Technology - Parana (UTFPR), Neoville, Curitiba, PR 81310-900, Brazil.'}, {'ForeName': 'Leandro C', 'Initials': 'LC', 'LastName': 'Felippe', 'Affiliation': 'Human Performance Research Group, Academic Department of Physical Education, Federal University of Technology - Parana (UTFPR), Neoville, Curitiba, PR 81310-900, Brazil.'}, {'ForeName': 'Guilherme A', 'Initials': 'GA', 'LastName': 'Ferreira', 'Affiliation': 'Human Performance Research Group, Academic Department of Physical Education, Federal University of Technology - Parana (UTFPR), Neoville, Curitiba, PR 81310-900, Brazil.'}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Learsi', 'Affiliation': 'Human Performance Research Group, Academic Department of Physical Education, Federal University of Technology - Parana (UTFPR), Neoville, Curitiba, PR 81310-900, Brazil.'}, {'ForeName': 'Patrícia G', 'Initials': 'PG', 'LastName': 'Couto', 'Affiliation': 'Endurance Sports Research Group (GEDAE-USP), University of São Paulo, São Paulo, SP 05508-030, Brazil.'}, {'ForeName': 'Romulo', 'Initials': 'R', 'LastName': 'Bertuzzi', 'Affiliation': 'Endurance Sports Research Group (GEDAE-USP), University of São Paulo, São Paulo, SP 05508-030, Brazil.'}, {'ForeName': 'Gleber', 'Initials': 'G', 'LastName': 'Pereira', 'Affiliation': 'Department of Physical Education, Federal University of Parana, Curitiba, PR 81531-980, Brazil.'}, {'ForeName': 'Adriano E', 'Initials': 'AE', 'LastName': 'Lima-Silva', 'Affiliation': 'Human Performance Research Group, Academic Department of Physical Education, Federal University of Technology - Parana (UTFPR), Neoville, Curitiba, PR 81310-900, Brazil.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0992']
689,31666651,Effects of attachment-based compassion therapy (ABCT) on brain-derived neurotrophic factor and low-grade inflammation among fibromyalgia patients: A randomized controlled trial.,"Fibromyalgia (FM) is a disabling syndrome characterized by chronic pain associated with fatigue. Its pathogenesis is unknown, but alterations in central sensitization, involving an imbalance of brain-derived neurotrophic factor (BDNF) and inflammatory biomarkers, appear to be implicated. The aim of this study was to evaluate the impact of attachment-based compassion therapy (ABCT) on levels of BDNF, the inflammatory markers TNF-α, IL-6, IL-10, and the C-reactive protein (CRP), analysing whether biomarkers play a mediating/moderating role in improvements in FM functional status. Thirty-four female patients with FM participated in a RCT and were assigned to ABCT or relaxation therapy. Blood extractions were conducted at baseline and post-intervention, with self-report assessments of functional status (FIQ) at baseline, post-intervention and 3-month follow-up. A pro-inflammatory composite was obtained by summing up IL-6, TNF-α and CRP normalized values. Non-parametric tests, analysis of variance and regression models were used to evaluate treatment and mediation/moderation. Compared to relaxation therapy, ABCT showed significant improvements in FIQ and decreases in BDNF, CRP, and pro-inflammatory composite. Changes in BDNF had a mediating role in FIQ. ABCT seems to reduce BDNF and appears to have anti-inflammatory effects in FM patients. Reductions in BDNF could be a mechanism of FM functional status improvement.Clinical Trial Registration: http://ClinicalTrials.gov , identifier NCT02454244. Date: May 27th, 2015.",2019,"Compared to relaxation therapy, ABCT showed significant improvements in FIQ and decreases in BDNF, CRP, and pro-inflammatory composite.","['Thirty-four female patients with FM participated in a', 'fibromyalgia patients']","['RCT', 'ABCT', 'attachment-based compassion therapy (ABCT', 'ABCT or relaxation therapy']","['BDNF, CRP, and pro-inflammatory composite', 'levels of BDNF, the inflammatory markers TNF-α, IL-6, IL-10, and the C-reactive protein (CRP', 'FIQ']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}]","[{'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",34.0,0.126247,"Compared to relaxation therapy, ABCT showed significant improvements in FIQ and decreases in BDNF, CRP, and pro-inflammatory composite.","[{'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Montero-Marin', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (redIAPP), Madrid, Spain. jmonteromarin@hotmail.com.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Andrés-Rodríguez', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (redIAPP), Madrid, Spain.'}, {'ForeName': 'Mattie', 'Initials': 'M', 'LastName': 'Tops', 'Affiliation': 'Department of Clinical, Neuro & Developmental Psychology, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Juan V', 'Initials': 'JV', 'LastName': 'Luciano', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (redIAPP), Madrid, Spain.'}, {'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Navarro-Gil', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, Zaragoza, Spain. maytenavarrogil@gmail.com.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Feliu-Soler', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (redIAPP), Madrid, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'López-Del-Hoyo', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Garcia-Campayo', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (redIAPP), Madrid, Spain.'}]",Scientific reports,['10.1038/s41598-019-52260-z']
690,31624297,Vitamin D Supplementation for Premenstrual Syndrome-Related inflammation and antioxidant markers in students with vitamin D deficient: a randomized clinical trial.,"Premenstrual syndrome (PMS) is a common disorder in the reproductive age that negatively significant impacts on women's quality of life. This randomized clinical trial study was undertaken to investigate the effect of vitamin D supplementation on inflammatory and antioxidant markers in 44 vitamin D deficient (25(OH)D < 20 ng/mL) students with PMS. Participants received either 50,000 IU vitamin D3 or a placebo pearl fortnightly for 4 months. At the baseline and in the last 2 months of intervention, participants were asked to complete the PMS Daily Symptoms Rating form along with taking the pearls and their blood samples were collected to assess serum levels of 25(OH)D 3 , Interleukin10 and 12 (IL-10, IL-12) and total antioxidant capacity (TAC). In vitamin D group, serum levels of IL-10 and IL-12 significantly decreased while TAC significantly increased post-intervention. There were significant differences regarding serum IL-12 and TAC levels between the two groups. Mean score of the total PMS symptoms showed significant improvement in 25(OH)D. Vitamin D supplementation seems to be an effective strategy to improve inflammation and antioxidant markers in vitamin D deficient women with PMS. This clinical trial was registered at Iranian Registry of Clinical Trials on 20/06/2018 (IRCT20180525039822N1).",2019,Mean score of the total PMS symptoms showed significant improvement in 25(OH)D. Vitamin D supplementation seems to be an effective strategy to improve inflammation and antioxidant markers in vitamin D deficient women with PMS.,"['vitamin D deficient women with PMS', '44 vitamin D deficient (25(OH)D\u2009<\u200920\u2009ng/mL) students with PMS', 'students with vitamin D deficient']","['vitamin D supplementation', 'vitamin D', '50,000 IU vitamin D3 or a placebo pearl', 'Vitamin D Supplementation']","['serum levels of IL-10 and IL-12', 'inflammatory and antioxidant markers', 'serum IL-12 and TAC levels', 'serum levels of 25(OH)D 3 , Interleukin10 and 12 (IL-10, IL-12) and total antioxidant capacity (TAC', 'inflammation and antioxidant markers', 'PMS Daily Symptoms Rating']","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0429688', 'cui_str': 'Symptom ratings (staging scale)'}]",44.0,0.522755,Mean score of the total PMS symptoms showed significant improvement in 25(OH)D. Vitamin D supplementation seems to be an effective strategy to improve inflammation and antioxidant markers in vitamin D deficient women with PMS.,"[{'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Heidari', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Amani', 'Affiliation': 'Professor of Nutrition. Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. r_amani@nutr.mui.ac.ir.'}, {'ForeName': 'Awat', 'Initials': 'A', 'LastName': 'Feizi', 'Affiliation': 'Professor of Biostatistics, Department of Biostatistics and Epidemiology, School of Health, Psychosomatic Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Askari', 'Affiliation': 'Associate Professor of Nutrition, Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Kohan', 'Affiliation': 'Associate Professor of Reproductive Health, Nursing and Midwifery Care Research Center, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Parastoo', 'Initials': 'P', 'LastName': 'Tavasoli', 'Affiliation': 'Molecular Research Lab,, School of Nutrition and Food Sciences, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Scientific reports,['10.1038/s41598-019-51498-x']
691,31688064,"Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.","OBJECTIVES
To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848).
METHODS
This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety.
RESULTS
Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
DISCUSSION
Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.",2019,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","['Patients With Nonerosive Gastroesophageal Reflux Disease', 'Japanese patients with NERD', 'patients with nonerosive reflux disease (NERD', 'Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn']","['placebo', 'Placebo', 'Vonoprazan', 'vonoprazan']","['cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution', 'safety', 'tolerated', 'cumulative rate of heartburn resolution', 'Incidence of treatment-emergent adverse events', 'efficacy and safety', 'complete heartburn resolution', 'heartburn symptoms', 'cumulative improvement rates of heartburn', 'proportion of days without heartburn', 'Efficacy and Safety', 'frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.488409,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.'}, {'ForeName': 'Yuuichi', 'Initials': 'Y', 'LastName': 'Sakurai', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Takabayashi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Araki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Internal Medicine, Fukuyama Daiichi Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ashida', 'Affiliation': 'Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000101']
692,31683021,Efficacy of Interpretation Bias Modification in Patients With Chronic Pain.,"Patients with chronic pain demonstrate interpretational bias to pain, and models of pain suggest interpretational bias affects subsequent pain experience. This study developed an interpretation bias modification for pain (IBM-P) and examined its efficacy. A total of 48 patients with chronic pain were recruited and randomly assigned to either the training group (n = 24) or the control group (n = 24). Interpretational bias, negative emotions, and attentional bias to pain-related stimuli were assessed before and after conducting IBM-P. The main results indicated that the training group showed less interpretational bias and negative emotions after IBM-P than the control group. The training group also gazed at neutral words longer than at ""new"" affective pain words after IBM-P than they did prior to the intervention. Furthermore, significant mediating effects of postinterpretational bias were found in the relationship between the group type and postnegative emotions and postdwell time bias. These results suggest that IBM-P can modify interpretational bias which leads to changes in negative emotions and attentional bias. Future research is needed to confirm the effect of modifying interpretational bias and its clinical utility in the field of pain management. PERSPECTIVE: This article investigated the efficacy of IBM-P and suggested that modifying interpretational bias is followed by changes in negative emotions and attentional bias. These findings may help health professionals understand the role of interpretational bias in chronic pain and encourage the potential use of IBM in pain management.",2020,The main results indicated that the training group showed less interpretational bias and negative emotions after IBM-P than the control group.,"['48 patients with chronic pain', 'Patients with Chronic Pain', 'Patients with chronic pain']",['Interpretation Bias Modification'],"['negative emotions and attentional bias', 'Interpretational bias, negative emotions, and attentional bias to pain-related stimuli', 'interpretational bias and negative emotions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",48.0,0.0286894,The main results indicated that the training group showed less interpretational bias and negative emotions after IBM-P than the control group.,"[{'ForeName': 'Jeongwi', 'Initials': 'J', 'LastName': 'An', 'Affiliation': 'Department of Psychology, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Kyeong-Seok', 'Initials': 'KS', 'LastName': 'Wang', 'Affiliation': 'Hearim Medical Clinic, Daejeon, Republic of Korea.'}, {'ForeName': 'Youn-Hee', 'Initials': 'YH', 'LastName': 'Jung', 'Affiliation': 'Department of Psychology, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Sungkun', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Psychology, Chungnam National University, Daejeon, Republic of Korea. Electronic address: sungkunc@cnu.ac.kr.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.10.005']
693,31790144,Dynamic Interactions Between LH and Testosterone in Healthy Community-Dwelling Men: Impact of Age and Body Composition.,"BACKGROUND
Aging is associated with diminished testosterone (Te) secretion, which may be attributed to Leydig cell dysfunction, decreased pituitary stimulation, and altered Te feedback.
OBJECTIVE
To study all regulatory nodes-gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and Leydig cell-in the same cohort of healthy men.
STUDY DESIGN
This was a placebo-controlled, blinded, prospectively randomized cross-over study in 40 men, age range 19 to 73 years, and body mass index (BMI) range 20 to 34.3 kg/m2. A submaximal dose of the GnRH antagonist ganirelix was used to assess outflow of GnRH, by calculating the difference between LH output during the control arm and ganirelix arm. Ketoconazole (a steroidogenic inhibitor) was used to estimate feedback, by the difference in LH output during the ketoconazole and control arm. High-dose ganirelix and repeated LH infusions were used to measure testicular responsivity. Blood sampling was performed at 10-minute intervals.
RESULTS
There were age-related, but not body composition-related decreases in estimated GnRH secretion, the feedback strength of Te on LH, and Leydig cell responsivity to LH, accompanied by changes in approximate entropy. Bioavailable Te levels were negatively related to both age and computed tomography (CT)-estimated abdominal visceral mass (AVF), without interaction between these variables. The LH response to a submaximal dose of GnRH was independent of age and AVF.
CONCLUSION
Advancing age is associated with (1) attenuated bioavailable Te secretion caused by diminished GnRH outflow and not by decreased GnRH responsivity of the gonadotrope, (2) diminished testicular responsivity to infused LH pulses, and (3) partial compensation by diminished Te feedback on central gonadotropic regulation.",2020,"Bioavailable Te levels were negatively related to both age and CT-estimated abdominal visceral mass (AVF), without interaction between these variables.","['Healthy Community-Dwelling Men', 'age range 19-73 yr, BMI range 20-34.3 kg/m2', 'healthy men', '40 men']","['placebo', 'Ketoconazole (steroidogenic inhibitor', 'LH and Testosterone', 'ketoconazole', 'ganirelix (GnRH antagonist']","['LH output', 'Bioavailable Te levels', 'LH response', 'testicular responsivity']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0073629', 'cui_str': 'ganirelix'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0686114,"Bioavailable Te levels were negatively related to both age and CT-estimated abdominal visceral mass (AVF), without interaction between these variables.","[{'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Roelfsema', 'Affiliation': 'Department of Internal Medicine, Section Endocrinology and Metabolism, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine at UCLA, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Los Angeles, California.'}, {'ForeName': 'Paul Y', 'Initials': 'PY', 'LastName': 'Takahashi', 'Affiliation': 'Department of Primary Care Internal Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Yang', 'Affiliation': 'Endocrine Research Unit, Mayo School of Graduate Medical Education, Center for Translational Science Activities, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Johannes D', 'Initials': 'JD', 'LastName': 'Veldhuis', 'Affiliation': 'Endocrine Research Unit, Mayo School of Graduate Medical Education, Center for Translational Science Activities, Mayo Clinic, Rochester, Minnesota.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz246']
694,30669914,Feasibility of computerized adventitious respiratory sounds to assess the effects of airway clearance techniques in patients with bronchiectasis.,"Objective: To examine the feasibility of adventitious respiratory sound (ARS) as an outcome measure to assess the effects of airway clearance techniques (ACTs) in outpatients with bronchiectasis. Methods: ARS were registered pre/post four ACTs sessions. Clinical outcomes included: number of crackles (coarse and fine), number of wheezes (monophonic and polyphonic), wheezes occupation rate (%) and sputum quantity. Feasibility outcomes of ARS included: reasons for exclusion, suitability, safety, equipment and time required, magnitude of change after intervention and sample size estimation. Results: Seven patients (49.7 ± 20.5 years; FEV 1 69.3 ± 15.8% predicted) were included. Recordings from four patients were excluded due to excessive environment noise. All ARS measurements were completed without any adverse events. An electronic stethoscope was acquired and the time spent to complete each assessment was 6 ± 3.5 min. The largest changes were observed for number of expiratory coarse crackles [effect size (95%CI) ES = 0.40 (0.01-0.79)], which correlated moderately with sputum quantity (r = 0.56), and inspiratory monophonic wheezes [ES = 0.61 (0.22-1.00)]. The estimated sample size for a full crossover trial was 46. Conclusions: ARS is feasible to assess the effects of ACTs in patients with bronchiectasis. Expiratory coarse crackles seem to be the most appropriate ARS parameter, but this finding needs to be confirmed in an adequately powered trial.",2020,"The largest changes were observed for number of expiratory coarse crackles [effect size (95%CI) ES = 0.40 (0.01-0.79)], which correlated moderately with sputum quantity (r = 0.56), and inspiratory monophonic wheezes [ES = 0.61 (0.22-1.00)].","['patients with bronchiectasis', 'outpatients with bronchiectasis', 'Seven patients (49.7\xa0±\xa020.5\xa0years; FEV 1 69.3\xa0±\xa015.8% predicted) were included']","['adventitious respiratory sound (ARS', 'computerized adventitious respiratory sounds', 'airway clearance techniques (ACTs']","['sputum quantity', 'exclusion, suitability, safety, equipment and time required, magnitude of change', 'number of crackles (coarse and fine), number of wheezes (monophonic and polyphonic), wheezes occupation rate (%) and sputum quantity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0035234', 'cui_str': 'Breathing Sounds'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220824', 'cui_str': 'equipment'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0034642', 'cui_str': 'Rales'}, {'cui': 'C0205194', 'cui_str': 'Coarse (qualifier value)'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}]",4.0,0.146175,"The largest changes were observed for number of expiratory coarse crackles [effect size (95%CI) ES = 0.40 (0.01-0.79)], which correlated moderately with sputum quantity (r = 0.56), and inspiratory monophonic wheezes [ES = 0.61 (0.22-1.00)].","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Herrero-Cortina', 'Affiliation': 'Health Sciences Faculty, Universidad San Jorge, Campus Universitario Villanueva de Gállego , Villanueva de Gállego, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oliveira', 'Affiliation': 'Lab 3R - Respiratory Research and Rehabilitation Laboratory, School of Health Sciences (ESSUA), University of Aveiro, Agras do Crasto - Campus Universitário de Santiago , Aveiro, Portugal.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Polverino', 'Affiliation': ""Institut de Recerca Vall d'Hebron (VHIR), Hospital Universitari Vall d'Hebron (HUVH), CIBERES , Barcelona, Spain.""}, {'ForeName': 'Eva María', 'Initials': 'EM', 'LastName': 'Gómez-Trullén', 'Affiliation': 'Faculty of Health and Sport Sciences, Department of Physiatry and Nursing, University of Zaragoza , Huesca, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Torres', 'Affiliation': 'Servei de Pneumologia, Hospital Clinic de Barcelona, Universitat de Barcelona, IDIBAPS, CIBERES , Barcelona, Spain.'}, {'ForeName': 'Alda', 'Initials': 'A', 'LastName': 'Marques', 'Affiliation': 'Lab 3R - Respiratory Research and Rehabilitation Laboratory, School of Health Sciences (ESSUA), University of Aveiro, Agras do Crasto - Campus Universitário de Santiago , Aveiro, Portugal.'}]",Physiotherapy theory and practice,['10.1080/09593985.2019.1566945']
695,31682682,Comparison of Group Medical Visits Combined With Intensive Weight Management vs Group Medical Visits Alone for Glycemia in Patients With Type 2 Diabetes: A Noninferiority Randomized Clinical Trial.,"Importance
Traditionally, group medical visits (GMVs) for persons with diabetes improved glycemia by intensifying medications, which infrequently led to weight loss. Incorporating GMVs with intensive dietary change could enable weight loss and improve glycemia while decreasing medication intensity.
Objective
To examine whether a program of GMVs combined with intensive weight management (WM) is noninferior to GMVs alone for change in glycated hemoglobin (HbA1c) level at 48 weeks (prespecified margin of 0.5%) and superior to GMVs alone for hypoglycemic events, diabetes medication intensity, and weight loss.
Design, Setting, and Participants
This randomized clinical trial identified via the electronic medical record 2814 outpatients with type 2 diabetes, uncontrolled HbA1c, and body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 27 or higher from Veterans Affairs Medical Center clinics in Durham and Greenville, North Carolina. Between January 12, 2015, and May 30, 2017, 263 outpatients started the intervention.
Interventions
Participants randomized to the GMV group (n = 136) received counseling about diabetes-related topics with medication optimization every 4 weeks for 16 weeks, then every 8 weeks (9 visits). Participants randomized to the WM/GMV group (n = 127) received low-carbohydrate diet counseling with baseline medication reduction and subsequent medication optimization every 2 weeks for 16 weeks followed by an abbreviated GMV intervention every 8 weeks (13 visits).
Main Outcomes and Measures
Outcomes included HbA1c level, hypoglycemic events, diabetes medication effect score, and weight at 48 weeks analyzed using hierarchical generalized mixed models to account for clustering within group sessions.
Results
Among 263 participants (mean [SD] age, 60.7 [8.2] years; 235 [89.4%] men; 143 [54.4%] black), baseline HbA1c level was 9.1% (1.3%) and BMI was 35.3 (5.1). At 48 weeks, HbA1c level was improved in both study arms (8.2% in the WM/GMV arm and 8.3% in the GMV arm; mean difference, -0.1%; 95% CI, -0.5% to 0.2%; upper 95% CI, <0.5% threshold; P = .44). The WM/GMV arm had lower diabetes medication use (mean difference in medication effect score, -0.5; 95% CI, -0.6 to -0.3; P < .001) and greater weight loss (mean difference, -3.7 kg; 95% CI, -5.5 to -1.9 kg; P < .001) than did the GMV arm at 48 weeks and approximately 50% fewer hypoglycemic events (incidence rate ratio, 0.49; 95% CI, 0.27 to 0.71; P < .001) during the 48-week period.
Conclusions and Relevance
In GMVs for diabetes, addition of WM using a low-carbohydrate diet was noninferior for lowering HbA1c levels compared with conventional medication management and showed advantages in other clinically important outcomes.
Trial Registration
ClinicalTrials.gov identifier: NCT01973972.",2019,"The WM/GMV arm had lower diabetes medication use (mean difference in medication effect score, -0.5; 95% CI, -0.6 to -0.3; P < .001) and greater weight loss (mean difference, -3.7 kg; 95% CI, -5.5 to -1.9 kg; P < .001) than did the GMV arm at 48 weeks and approximately 50% fewer hypoglycemic events (incidence rate ratio, 0.49; 95% CI, 0.27 to 0.71; P < .001) during the 48-week period.
","['Between January 12, 2015, and May 30, 2017, 263 outpatients started the intervention', '2814 outpatients with type 2 diabetes, uncontrolled HbA1c, and body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 27 or higher from Veterans Affairs Medical Center clinics in Durham and Greenville, North Carolina', '60.7 [8.2] years; 235 [89.4%] men; 143 [54.4%] black', '2 Diabetes', 'Patients With Type', '263 participants (mean [SD] age', 'persons with diabetes']","['GMV', 'WM/GMV', 'low-carbohydrate diet counseling with baseline medication reduction and subsequent medication optimization every 2 weeks for 16 weeks followed by an abbreviated GMV intervention', 'Intensive Weight Management vs Group Medical Visits', 'Group Medical Visits', 'counseling about diabetes-related topics with medication optimization', 'GMVs combined with intensive weight management (WM']","['HbA1c level', 'weight loss and improve glycemia', 'HbA1c level, hypoglycemic events, diabetes medication effect score, and weight', 'glycated hemoglobin (HbA1c) level', 'hypoglycemic events, diabetes medication intensity, and weight loss', 'baseline HbA1c level', 'weight loss', 'hypoglycemic events', 'BMI']","[{'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0454851', 'cui_str': 'Durham (geographic location)'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1319171', 'cui_str': 'Medication response'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",263.0,0.125306,"The WM/GMV arm had lower diabetes medication use (mean difference in medication effect score, -0.5; 95% CI, -0.6 to -0.3; P < .001) and greater weight loss (mean difference, -3.7 kg; 95% CI, -5.5 to -1.9 kg; P < .001) than did the GMV arm at 48 weeks and approximately 50% fewer hypoglycemic events (incidence rate ratio, 0.49; 95% CI, 0.27 to 0.71; P < .001) during the 48-week period.
","[{'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Yancy', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Department of Veterans Affairs, Durham, North Carolina.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Department of Veterans Affairs, Durham, North Carolina.'}, {'ForeName': 'Moahad S', 'Initials': 'MS', 'LastName': 'Dar', 'Affiliation': 'Greenville Health Care Center, Department of Veterans Affairs, Greenville, North Carolina.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Department of Veterans Affairs, Durham, North Carolina.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Jeffreys', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Department of Veterans Affairs, Durham, North Carolina.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Maciejewski', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Department of Veterans Affairs, Durham, North Carolina.'}, {'ForeName': 'Corrine I', 'Initials': 'CI', 'LastName': 'Voils', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}, {'ForeName': 'Anna Barton', 'Initials': 'AB', 'LastName': 'Bradley', 'Affiliation': 'Bon Secours Health System, Richmond, Virginia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edelman', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Department of Veterans Affairs, Durham, North Carolina.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.4802']
696,30689098,Adherence to CPAP with a nasal mask combined with mandibular advancement device versus an oronasal mask: a randomized crossover trial.,"PURPOSE
Evidence for the management of CPAP-treated obstructive sleep apnea suggests that oronasal masks reduce mouth leaks at the expense of higher pressures and poorer adherence. Some authors have proposed the use of mandibular advancement devices in combination with nasal masks to address this. The aim of this study was to assess adherence to CPAP after 1 month's use of a nasal mask with a mandibular advancement device and to compare adherence with an oronasal mask.
METHODS
A randomized crossover trial design to assess whether a mandibular advancement device combined with a nasal mask would improve CPAP adherence compared to an oronasal mask.
RESULTS
There was no improvement in CPAP adherence and self-reported interface-related pain was significantly higher with the combined treatment.
CONCLUSIONS
Although the combined treatment reduced pressures, likely by improving upper airway patency, it may only be appropriate for a small number of patients due to associated discomfort.
TRIAL REGISTRATION
NCT01889472.",2019,"There was no improvement in CPAP adherence and self-reported interface-related pain was significantly higher with the combined treatment.
",['CPAP-treated obstructive sleep apnea'],"['mandibular advancement device combined with a nasal mask', 'nasal mask with a mandibular advancement device', 'CPAP with a nasal mask combined with mandibular advancement device versus an oronasal mask']","['CPAP adherence and self-reported interface-related pain', 'CPAP adherence']","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0376461', 'cui_str': 'Mandibular Advancement'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2711254', 'cui_str': 'Dental mask'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0024861', 'cui_str': 'Masks'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.177168,"There was no improvement in CPAP adherence and self-reported interface-related pain was significantly higher with the combined treatment.
","[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Léotard', 'Affiliation': 'HP2, INSERM U1042, University Grenoble Alpes, F-38000, Grenoble, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Lesgoirres', 'Affiliation': 'AGIR à dom. Association, 36 bd du Vieux Chêne, F-38240, Meylan, France.'}, {'ForeName': 'Najeh', 'Initials': 'N', 'LastName': 'Daabek', 'Affiliation': 'HP2, INSERM U1042, University Grenoble Alpes, F-38000, Grenoble, France.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Lebret', 'Affiliation': 'HP2, INSERM U1042, University Grenoble Alpes, F-38000, Grenoble, France. mariuslebret@gmail.com.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Bailly', 'Affiliation': 'HP2, INSERM U1042, University Grenoble Alpes, F-38000, Grenoble, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Verain', 'Affiliation': ""Sleep and Exercise Laboratory, Thorax-Vaisseaux Department, Grenoble-Alpes University Hospital, Saint-Martin-d'Hères, France.""}, {'ForeName': 'Fréderic', 'Initials': 'F', 'LastName': 'Series', 'Affiliation': ""Centre de recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) Université Laval, Québec, QC, G1V4G5, Canada.""}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pépin', 'Affiliation': 'HP2, INSERM U1042, University Grenoble Alpes, F-38000, Grenoble, France.'}, {'ForeName': 'Jean-Christian', 'Initials': 'JC', 'LastName': 'Borel', 'Affiliation': 'HP2, INSERM U1042, University Grenoble Alpes, F-38000, Grenoble, France.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-018-01772-5']
697,31615279,"Preservative-free versus preserved brimonidine %0.15 preparations in the treatment of glaucoma and ocular hypertension: short term evaluation of efficacy, safety, and potential advantages.","Purpose: To compare the efficacy, safety, and potential advantages of the preservative-free versus preserved brimonidine %0.15 preparations in patients with primer open-angle glaucoma (POAG) or ocular hypertension (OHT). Methods: Forty-two eyes of the 21 treatment-naive patients with POAG or OHT were enrolled in this study. Eyes were randomly assigned to receive brimonidine-purite 0.15% or preservative-free brimonidine 0.15% two times daily. Efficacy of the two eye drops was assessed by measuring the intraocular pressure (IOP) at 9-10 am at baseline and week 4. Safety and potential advantages of the drops were evaluated at weeks 4 in terms of ocular symptoms and tear parameters. Ocular symptom values of the patients were evaluated with a scale of 0-4 (0 = no discomfort and 4 = severe discomfort). Results: Both of the brimonidine tartrate formulations resulted in statistically similar IOP reduction (preserved formulation; -5.2 mmHg [22.9% reduction] preservative-free formulation; -5.7 mmHg [24.1% reduction], p = 0.37). It was found that brimonidine tartrate formulations with and without topical preservatives did not produce a statistically significant difference in pain, stinging, and blurred vision at the upon instillation ( p > 0.05). However, the burning sensation was significantly higher in the preservative-free formulation at the first instillation compared to the preserved formulation ( p = 0.01). Also, there was no statistically significant difference between the two formulations in terms of symptoms (itching, burning, tearing, stinging, and photophobia) and tear parameters during the day ( p > 0.05). Conclusions: Although topical preservative-free brimonidine tartrate treated eyes had a more burning sensation at the first drop, the two formulations were similar in terms of ocular tolerability in the short term period. Also, both formulations were found to reduce IOP at a similar rate.",2020,"It was found that brimonidine tartrate formulations with and without topical preservative did not produce a statistically significant difference in pain, stinging, blurred vision at the upon instillation ( p > 0.05).","['patients with primer open-angle glaucoma (POAG) or ocular hypertension (OHT', 'Glaucoma and Ocular Hypertension', 'Methods: Forty-two eyes of the 21 treatment-naive patients with POAG or OHT were enrolled in the present study']","['brimonidine', 'brimonidine tartrate formulations', 'Preservative-Free versus Preserved Brimonidine', 'brimonidine-purite 0.15% or preservative-free brimonidine', 'preservative-free versus preserved brimonidine', 'topical preservative-free brimonidine tartrate']","['Ocular symptom values', 'intraocular pressure (IOP', 'ocular tolerability', 'reduction] preservative-free formulation', 'IOP reduction', 'symptoms (itching, burning, tearing, stinging, photophobia) and tear parameters', 'efficacy, safety and potential advantages', 'burning sensation', 'IOP', 'pain, stinging, blurred vision']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}, {'cui': 'C0851409', 'cui_str': 'Glaucoma and ocular hypertension'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0525227', 'cui_str': 'brimonidine'}, {'cui': 'C0077768', 'cui_str': 'Brimonidine tartrate'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C2003511', 'cui_str': 'Brimonidine Purite'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0085636', 'cui_str': 'Light Sensitivity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042789', 'cui_str': 'Vision'}]",,0.0222764,"It was found that brimonidine tartrate formulations with and without topical preservative did not produce a statistically significant difference in pain, stinging, blurred vision at the upon instillation ( p > 0.05).","[{'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Duru', 'Affiliation': 'Department of Ophthalmology, Kayseri City Training and Research Hospital, Kayseri, Turkey.'}, {'ForeName': 'Cemal', 'Initials': 'C', 'LastName': 'Ozsaygili', 'Affiliation': 'Department of Ophthalmology, Kayseri City Training and Research Hospital, Kayseri, Turkey.'}]",Cutaneous and ocular toxicology,['10.1080/15569527.2019.1680685']
698,31680600,Ketamine-induced changes in plasma brain-derived neurotrophic factor (BDNF) levels are associated with the resting-state functional connectivity of the prefrontal cortex.,"OBJECTIVES
Synaptic plasticity and brain-derived neurotrophic factor (BDNF) signalling are proposed to play key roles in antidepressant drug action. Ketamine, an N-methyl-D-aspartate receptor antagonist and putative antidepressant, may increase synaptic plasticity in prefrontal cortex through higher expression of BDNF. Furthermore, ketamine was shown to change resting-state functional connectivity (RSFC) of dorsomedial prefrontal cortex (dmPFC).
METHODS
In a randomised, placebo-controlled study, we investigated acutely (100 min) and at 24 h following subanesthetic ketamine infusion which dmPFC seeded RSFC changes are most strongly associated with plasma BDNF level changes in 53 healthy participants (21 females, age: 24.4 ± 2.9 years) using 7 T-fMRI.
RESULTS
We observed higher relative levels of BDNF 2 h and 24 h after ketamine compared to placebo. Whole-brain regression revealed that the change in BDNF after 24 h was associated with RSFC decreases from dmPFC to posterior cingulate cortex and ventromedial PFC at 24 h and exploratively also at the 100 min measurement point. Follow-up analyses revealed that RSFC reductions following ketamine were restricted to subjects showing increased BDNF levels at 24 h.
CONCLUSIONS
Our findings indicate BDNF level dynamics following ketamine are related to acute and 24 h RSFC changes. Particularly when BDNF increases are observed after ketamine infusion, a disconnection from dmPFC after 24 h is seen and may reflect synaptic plasticity effects.",2020,We observed higher relative levels of BDNF 2 h and 24 h after ketamine compared to placebo.,"['53 healthy participants (21 females, age: 24.4\u2009±\u20092.9 years) using 7\u2009T-fMRI']","['Ketamine', 'ketamine', 'placebo', 'subanesthetic ketamine', 'Synaptic plasticity and brain-derived neurotrophic factor']","['RSFC reductions', 'change resting-state functional connectivity (RSFC) of dorsomedial prefrontal cortex (dmPFC', 'plasma brain-derived neurotrophic factor (BDNF) levels', 'plasma BDNF level changes', 'BDNF levels']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027880', 'cui_str': 'Neural Plasticity'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",53.0,0.0458523,We observed higher relative levels of BDNF 2 h and 24 h after ketamine compared to placebo.,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Woelfer', 'Affiliation': 'Clinical Affective Neuroimaging Laboratory (CANLAB), Magdeburg, Germany.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Clinical Affective Neuroimaging Laboratory (CANLAB), Magdeburg, Germany.'}, {'ForeName': 'Lejla', 'Initials': 'L', 'LastName': 'Colic', 'Affiliation': 'Clinical Affective Neuroimaging Laboratory (CANLAB), Magdeburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Liebe', 'Affiliation': 'Clinical Affective Neuroimaging Laboratory (CANLAB), Magdeburg, Germany.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Di', 'Affiliation': 'Department of Biomedical Engineering, New Jersey Institute of Technology, Newark, NJ, USA.'}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Biswal', 'Affiliation': 'Department of Biomedical Engineering, New Jersey Institute of Technology, Newark, NJ, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murrough', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Lessmann', 'Affiliation': 'Institute of Physiology, Otto-von-Guericke-University, Magdeburg, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Brigadski', 'Affiliation': 'Institute of Physiology, Otto-von-Guericke-University, Magdeburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'Clinical Affective Neuroimaging Laboratory (CANLAB), Magdeburg, Germany.'}]",The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry,['10.1080/15622975.2019.1679391']
699,31679812,Effectiveness of group visits for elderly patients with type 2 diabetes in an urban community in China.,"The purpose of this study is to evaluate the effectiveness of a group visit intervention in comparison with the usual care for elderly patients with type 2 diabetes in a community. We randomized 109 community elderly patients with type 2 diabetes to the intervention group (n = 55) of monthly group visits sessions or to a control group (n = 54) of usual care. Repeated measures analysis of variance was used to compare the changes in HbA1 C , diabetes knowledge, self-efficacy, and self-management behavior in both groups. At the 6-month follow-up, although no significant difference was observed between the groups regarding HbA1 C (p = 0.272). Diabetes knowledge, self-efficacy and self-management scores were higher in patients in the intervention group than that in the control group (p < 0.05). The group visits model increased diabetes knowledge and self-efficacy and improved patients' self-management behavior. The model was found suitable for helping these elderly patients with type 2 diabetes achieve effective self-management.",2020,"Diabetes knowledge, self-efficacy and self-management scores were higher in patients in the intervention group than that in the control group (p < 0.05).","['109 community elderly patients with type 2 diabetes to the intervention group (n\u202f=\u202f55) of', 'elderly patients with type 2 diabetes in a community', 'elderly patients with type 2 diabetes in an urban community in China', 'elderly patients with type 2 diabetes']",['monthly group visits sessions or to a control group (n\u202f=\u202f54) of usual care'],"[""diabetes knowledge and self-efficacy and improved patients' self-management behavior"", 'Diabetes knowledge, self-efficacy and self-management scores', 'changes in HbA1 C , diabetes knowledge, self-efficacy, and self-management behavior']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]",109.0,0.0131256,"Diabetes knowledge, self-efficacy and self-management scores were higher in patients in the intervention group than that in the control group (p < 0.05).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, Qingdao University, Qingdao, Shandong province, China.'}, {'ForeName': 'Liangxiu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Medical College, Quzhou College of Technology, Quzhou, Zhejiang province, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Cui', 'Affiliation': 'The 2nd Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang province, China.'}, {'ForeName': 'Yanni', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'The 2nd Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang province, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': 'The 2nd Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang province, China.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'The Anbu community of Harbin, Harbin, Heilongjiang province, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'The 2nd Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang province, China. Electronic address: 13603618212@126.com.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2019.10.001']
700,31658037,"Osteopathic manipulation treatment versus therapeutic exercises in patients with chronic nonspecific low back pain: A randomized, controlled and double-blind study.","BACKGROUND
Osteopathic manipulation treatment is widely used in the clinical practice in the care of patients with chronic nonspecific low back pain, however, its benefits still seem uncertain.
OBJECTIVE
This study aimed to verify the efficacy of osteopathic manipulation for chronic nonspecific low back pain.
MATERIALS AND METHODS
Forty-two participants with chronic nonspecific low back pain were selected and randomized into two groups: active control group (ACG - n= 19) and osteopathic manipulation treatment group (OMTG - n= 23). Therapeutic exercises were performed with the ACG and osteopathic manipulation techniques with the OMTG. The interventions were carried out over 5 weeks of treatment, totaling 10 treatments for the ACG and 5 for the OMTG.The visual analogue scale (VAS) was used to measure chronic nonspecific low back pain and the Oswestry Disability Index 2.0, Tampa Scale of Kinesiophobia and Beck Depression Inventory were used to measure disability, kinesiophobia and depression, respectively.
RESULTS
The final chronic nonspecific low back pain in both groups was significantly lower than the initial low back pain (p⩽ 0.01) and the final chronic nonspecific low back pain of the OMTG was significantly lower than that of the ACG (p= 0.001).
CONCLUSION
This study demonstrated that the treatments were effective in both groups. However, the efficacy of the osteopathic manipulation treatment was greater than that of the therapeutic exercises.",2020,"The final chronic nonspecific low back pain in both groups was significantly lower than the initial low back pain (p⩽ 0.01) and the final chronic nonspecific low back pain of the OMTG was significantly lower than that of the ACG (p= 0.001).
","['chronic nonspecific low back pain', 'patients with chronic nonspecific low back pain', 'Forty-two participants with chronic nonspecific low back pain']","['osteopathic manipulation', 'Active Control Group (ACG - n= 19) and Osteopathic Manipulation Treatment Group (OMTG - n= 23', 'ACG and 5 for the OMTG.The visual analogue scale (VAS', 'Osteopathic manipulation treatment versus therapeutic exercises']","['final chronic nonspecific low back pain of the OMTG', 'final chronic nonspecific low back pain', 'chronic nonspecific low back pain and the Oswestry Disability Index 2.0, Tampa Scale of Kinesiophobia and Beck Depression Inventory']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}]","[{'cui': 'C0949744', 'cui_str': 'Osteopathic Manipulative Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0050397', 'cui_str': 'insulin potentiating fragments of growth hormone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}]",42.0,0.0281486,"The final chronic nonspecific low back pain in both groups was significantly lower than the initial low back pain (p⩽ 0.01) and the final chronic nonspecific low back pain of the OMTG was significantly lower than that of the ACG (p= 0.001).
","[{'ForeName': 'Frederico', 'Initials': 'F', 'LastName': 'de Oliveira Meirelles', 'Affiliation': 'Estacio de Sá University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Júlio César', 'Initials': 'JC', 'LastName': 'de Oliveira Muniz Cunha', 'Affiliation': 'Estacio de Sá University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Elirez Bezerra', 'Initials': 'EB', 'LastName': 'da Silva', 'Affiliation': 'Instituto de Educação Física e Desportos, Rio de Janeiro State University, Brazil, Rio de Janeiro.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181355']
701,31829170,Benefits of ultra-fast-track anesthesia for children with congenital heart disease undergoing cardiac surgery.,"BACKGROUND
To compare the outcomes of ultra-fast-track anesthesia (UFTA) and conventional anesthesia in cardiac surgery for children with congenital heart disease (CHD) and low birth weight.
METHODS
One hundred and ninety-four CHD children, aged 6 months to 2 years, weighting 5 to 10 kg, were selected for this study. The 94 boys and 100 girls with the American Society of Anesthesiologists (ASA) physical status III and IV were randomly divided into two groups each consisting of 97 patients, and were subjected to ultra-fast-track and conventional anesthesia for cardiac surgery. For children in UFTA group, sevoflurane was stopped when cardiopulmonary bypass (CPB) started and cis-atracurium was stopped at the beginning of rewarming, and remifentanil (0.3 μg/kg/mim) was then infused. Propofol and remifentanil were discontinued at skin closure. 10 min after surgery, extubation was performed in operating room. For children in conventional anesthesia group, anesthesia was given routinely and they were directly sent to ICU with a tracheal tube. Extubation time, ICU stay and hospital stay after operation were recorded. Sedation-agitation scores (SAS) were assessed and adverse reactions as well as other anesthesia -related events were recorded.
RESULTS
The extubation time, ICU stay and hospital stay were significantly shorter in UFTA group (P < 0.05) and SAS at extubation was lower in UFTA group than in conventional anesthesia group, but similar in other time points. For both groups, no airway obstruction and other serious complications occurred, and incidence of other anesthesia -related events were low.
CONCLUSIONS
UFTA shortens extubation time, ICU stay and hospital stay for children with CHD and does not increase SAS and incidence of adverse reactions.",2019,"The extubation time, ICU stay and hospital stay were significantly shorter in UFTA group (P < 0.05) and SAS at extubation was lower in UFTA group than in conventional anesthesia group, but similar in other time points.","['94 boys and 100 girls with the American Society of Anesthesiologists (ASA) physical status III and IV', 'One hundred and ninety-four CHD children, aged 6\u2009months to 2\u2009years, weighting 5 to 10\u2009kg', 'children with congenital heart disease (CHD) and low birth weight', 'children with CHD', 'children with congenital heart disease undergoing cardiac surgery']","['ultra-fast-track and conventional anesthesia for cardiac surgery', 'ultra-fast-track anesthesia (UFTA) and conventional anesthesia', 'remifentanil', 'sevoflurane', 'ultra-fast-track anesthesia', 'Propofol and remifentanil']","['Sedation-agitation scores (SAS', 'extubation time, ICU stay and hospital stay', 'Extubation time, ICU stay and hospital stay after operation', 'SAS and incidence of adverse reactions', 'SAS at extubation', 'no airway obstruction and other serious complications']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0001883', 'cui_str': 'Airway Obstruction'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",194.0,0.0318834,"The extubation time, ICU stay and hospital stay were significantly shorter in UFTA group (P < 0.05) and SAS at extubation was lower in UFTA group than in conventional anesthesia group, but similar in other time points.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, China Emergency General Hospital, 29 Liufangnanli Rd, Beijing, 100028, China.'}, {'ForeName': 'Guanghua', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, China Emergency General Hospital, 29 Liufangnanli Rd, Beijing, 100028, China.'}, {'ForeName': 'Yanpei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, China Emergency General Hospital, 29 Liufangnanli Rd, Beijing, 100028, China. yanpei508@163.com.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, China Emergency General Hospital, 29 Liufangnanli Rd, Beijing, 100028, China. lina13120@163.com.'}]",BMC pediatrics,['10.1186/s12887-019-1832-9']
702,31144279,"Effects of a Transitional Care Practice for a Vulnerable Population: a Pragmatic, Randomized Comparative Effectiveness Trial.","BACKGROUND
There is limited experimental evidence on transitional care interventions beyond 30 days post-discharge and in vulnerable populations.
OBJECTIVE
Evaluate effects of a transitional care practice (TC) that comprehensively addresses patients' medical and psychosocial needs following hospital discharge.
DESIGN
Pragmatic, randomized comparative effectiveness trial.
PATIENTS
Adults discharged from an initial emergency, observation, or inpatient hospital encounter with no trusted usual source of care.
INTERVENTIONS
TC intervention included a scheduled post-discharge appointment at the TC practice, where a multidisciplinary team comprehensively assessed patients' medical and psychosocial needs, addressed modifiable barriers, and subsequent linkage to a new primary care source. Routine Care involved assistance scheduling a post-discharge appointment with a primary care provider that often partnered with the hospital where the initial encounter occurred.
MAIN MEASURES
The primary outcome was a binary indicator of death or additional hospital encounters within 90 days of initial discharge. Secondary outcomes included any additional hospital encounters, and counts of hospital encounters, over 180 days.
KEY RESULTS
Four hundred ninety patients were randomized to TC intervention and 164 to Routine Care; 34.6% were uninsured, 49.7% had Medicaid, and 57.4% were homeless or lived in a high-poverty area. There was no significant difference between arms in the 90-day probability of death or additional hospital encounters (relative risk [RR] 0.89; 0.91; 95% confidence interval [CI] 0.74-1.13). However, TC patients had 37% and 35% lower probability of any inpatient admission over 90 days (RR 0.63; 95% CI 0.43-0.91) and 180 days (RR 0.65; 95% CI 0.47-0.89), respectively. Over 180 days, TC patients had 42% fewer inpatient admissions (incidence rate ratio 0.58; 95% CI 0.37-0.90).
CONCLUSIONS
Among patients randomized to a patient-centered transitional care intervention, there was no significant reduction in 90-day probability of death or additional hospital encounters. However, there were significant decreases in measures of inpatient admissions over 180 days.
TRIAL REGISTRATION
clinicaltrials.gov identifier NCT03066492.",2019,"Over 180 days, TC patients had 42% fewer inpatient admissions (incidence rate ratio 0.58; 95% CI 0.37-0.90).
","['Vulnerable Population', 'Four hundred ninety patients were randomized to TC intervention and 164 to Routine Care; 34.6% were uninsured, 49.7% had Medicaid, and 57.4% were homeless or lived in a high-poverty area', 'Adults discharged from an initial emergency, observation, or inpatient hospital encounter with no trusted usual source of care']","['Transitional Care Practice', ""TC intervention included a scheduled post-discharge appointment at the TC practice, where a multidisciplinary team comprehensively assessed patients' medical and psychosocial needs, addressed modifiable barriers, and subsequent linkage to a new primary care source"", 'transitional care practice (TC']","['inpatient admissions', '90-day probability of death or additional hospital encounters', 'additional hospital encounters, and counts of hospital encounters, over 180\xa0days', 'binary indicator of death or additional hospital encounters within 90\xa0days of initial discharge', 'probability of any inpatient admission', 'measures of inpatient admissions']","[{'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032855', 'cui_str': 'Poverty Areas'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}]","[{'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}]","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",490.0,0.412341,"Over 180 days, TC patients had 42% fewer inpatient admissions (incidence rate ratio 0.58; 95% CI 0.37-0.90).
","[{'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Liss', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. david.liss@northwestern.edu.'}, {'ForeName': 'Ronald T', 'Initials': 'RT', 'LastName': 'Ackermann', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cooper', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Finch', 'Affiliation': 'Center for Community Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Hurt', 'Affiliation': 'PCPI Foundation, Chicago, IL, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lancki', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Avani', 'Initials': 'A', 'LastName': 'Sheth', 'Affiliation': 'Department of Family and Community Medicine, Cook County Health and Hospitals System, Chicago, IL, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Teter', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schaeffer', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05078-4']
703,31673858,"Incidence of postoperative pain after canal shaping by using Reciproc and Twisted File Adaptive systems: a prospective, randomized clinical trial.","OBJECTIVES
The aim of this prospective clinical trial was to investigate the incidence of postoperative pain after initial root canal treatment using Twisted File Adaptive (TFA) and Reciproc systems.
MATERIALS AND METHODS
A total of sixty-four previously initiated or necrotic posterior teeth were randomly assigned to two groups based on the rotary system used; TFA (SybronEndo, Orange, Ca) (n = 35) and Reciproc (VDW, Munich, Germany) (n = 29). All teeth were treated in a single visit. Patients were contacted to assess the level of postoperative pain on a visual analog scale after treatment by 6 h, 24 h, 48 h, 72 h, and 1 week. Patients were also asked to report if any medication was taken during the follow-up period. The postoperative pain scores were analyzed by Mann-Whitney test with respect to follow-up interval at a significance level of 0.05.
RESULTS
Patients treated with TFA reported significantly lower postoperative pain levels at 24 h, 48 h, and 72 h compared with those in Reciproc group (p < 0.01). There were no significant differences between the two groups at 6 h and 1-week follow-up intervals (p > 0.05). About 11% (TFA) and 24% (Reciproc) of the treated patients took analgesics, but none of them took antibiotics during the follow-up period.
CONCLUSIONS
The tested rotary systems induced postoperative pain after root canal treatment. The TFA system was found to induce less pain scores compared with the Reciproc system after the treatment by 24 h, 48 h, and 72 h.
CLINICAL RELEVANCE
The level of postoperative pain was low after the root canal treatment with the Twisted File Adaptive system compared with the Reciproc system.",2020,The level of postoperative pain was low after the root canal treatment with the Twisted File Adaptive system compared with the Reciproc system.,['A total of sixty-four previously initiated or necrotic posterior teeth'],"['initial root canal treatment using Twisted File Adaptive (TFA) and Reciproc systems', 'rotary system used; TFA (SybronEndo, Orange, Ca) (n = 35) and Reciproc (VDW, Munich, Germany', 'canal shaping by using Reciproc and Twisted File Adaptive systems', 'TFA']","['postoperative pain', 'pain scores', 'postoperative pain scores', 'level of postoperative pain on a visual analog scale', 'level of postoperative pain', 'postoperative pain levels']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0086881', 'cui_str': 'Root Canal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040480', 'cui_str': 'Musculoskeletal torsion (observable entity)'}, {'cui': 'C0180853', 'cui_str': 'File, device (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0440277', 'cui_str': 'Oranges'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",64.0,0.0357202,The level of postoperative pain was low after the root canal treatment with the Twisted File Adaptive system compared with the Reciproc system.,"[{'ForeName': 'Taher', 'Initials': 'T', 'LastName': 'AlOmari', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Ghadah', 'Initials': 'G', 'LastName': 'AlThobiti', 'Affiliation': 'Specialized Dental Center, Department of Endodontics, Ministry of Health, Taif, Saudi Arabia.'}, {'ForeName': 'Sabri', 'Initials': 'S', 'LastName': 'AlThobaiti', 'Affiliation': 'King Abdulaziz Medical City, Ministry of National Guard-Health Affairs, Jeddah, Saudi Arabia.'}, {'ForeName': 'Fayez', 'Initials': 'F', 'LastName': 'AlOufi', 'Affiliation': 'Department of Endodontics, Dental Specialist Center, King Fahad Hospital, Ministry of Health, Medina, Saudi Arabia.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Masuadi', 'Affiliation': 'Department of Medical Education, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Jamleh', 'Affiliation': 'Department of Medical Education, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. aojamleh@gmail.com.'}]",Clinical oral investigations,['10.1007/s00784-019-03106-5']
704,31667501,Pilot Randomized Controlled Trial of a Novel Smoking Cessation App Designed for Individuals With Co-Occurring Tobacco Use Disorder and Serious Mental Illness.,"INTRODUCTION
High rates of tobacco use among people with serious mental illness (SMI), along with their unique needs, suggest the importance of developing tailored smoking cessation interventions for this group. Previous early-phase work empirically validated the design and content of Learn to Quit, a theory-based app designed for this population.
METHODS
In a pilot randomized controlled trial, we compared the feasibility, acceptability, and preliminary efficacy of Learn to Quit versus QuitGuide, an app designed for the general population. All participants received nicotine replacement therapy and technical assistance. Daily smokers with SMI (N = 62) participated in the trial with outcomes assessed at weeks 4, 8, 12, and 16.
RESULTS
Compared to QuitGuide, Learn to Quit participants had similar number of days of app use (34 vs. 32, p = .754), but larger number of app interactions (335 vs. 205; p = .001), longer durations of app use (4.24 hrs. vs. 2.14 hrs; p = .044), and higher usability scores (85 vs. 79, p = .046). At week 16, Learn to Quit led to greater reductions in cigarettes per day (12.3 vs. 5.9 for QuitGuide; p = 0.10). Thirty-day point prevalence abstinence was verified in 12% of Learn to Quit participants versus 3% of QuitGuide participants (odds ratio = 3.86, confidence interval = 0.41 to 36, p = .239). Changes in psychiatric symptoms and adverse events were not clinically significant between conditions.
CONCLUSIONS
This pilot trial provides strong evidence of Learn to Quit's usability, feasibility, and safety. Preliminary evidence suggests the app may be efficacious. A randomized controlled efficacy trial is needed to test the app in a larger sample of smokers with SMI.
IMPLICATIONS
This study suggests that the Learn to Quit app is a feasible approach to deliver smoking cessation treatment in patients with co-occurring tobacco use disorder and SMI. This means that, if found efficacious, this technology could be used to deploy smoking cessation treatment to larger segments of this population, hence improving public health. Therefore, a randomized controlled trial should be conducted to examine the efficacy of this digital intervention.",2020,"At week 16, Learn to Quit led to greater reductions in cigarettes per day (12.3 vs 5.9 for QuitGuide; p<0.01).","['Individuals with Co-Occurring Tobacco Dependence and Serious Mental Illness', 'people with serious mental illness (SMI', 'larger sample of smokers with SMI', 'Daily smokers with SMI (N=62) participated in the trial with outcomes assessed at weeks 4, 8, 12, and 16', 'patients with co-occurring tobacco use disorder and serious mental illness']","['nicotine replacement therapy and technical assistance', 'Novel Smoking Cessation App', 'Learn to Quit versus QuitGuide']","['higher usability scores', 'prevalence abstinence', 'psychiatric symptoms and adverse events']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0040332', 'cui_str': 'Tobacco Dependence'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040336', 'cui_str': 'Tobacco Use Disorder'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.229352,"At week 16, Learn to Quit led to greater reductions in cigarettes per day (12.3 vs 5.9 for QuitGuide; p<0.01).","[{'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Vilardaga', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Rizo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}, {'ForeName': 'Paige E', 'Initials': 'PE', 'LastName': 'Palenski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Mannelli', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Oliver', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Mcclernon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz202']
705,31789486,Efficacy of drug-coated balloon angioplasty in early versus late occurring drug-eluting stent restenosis: A pooled analysis from the randomized ISAR DESIRE 3 and DESIRE 4 trials.,"BACKGROUND
Whether there exist differences concerning clinical outcomes between patients presenting with early versus late DES-ISR undergoing treatment with drug-coated balloons (DCB) remains a scientific knowledge gap.
METHODS
This is a pooled analysis including patients with DES-ISR assigned to treatment with DCB in the setting of the ISAR DESIRE 3 and 4 trials. Clinical outcomes were evaluated according to time of occurrence of ISR after DES implantation, in patients presenting with early (≤12 months) versus late DES-ISR (>12 months) undergoing treatment with DCB. The primary endpoint of this analysis was major adverse cardiac event (MACE), defined as the combined incidence of death, myocardial infarction and target lesion revascularization (TLR) at 12 months after DCB treatment. Secondary endpoints included the incidence of death, myocardial infarction, TLR and target lesion thrombosis at 12 months after DCB treatment.
RESULTS
This analysis included 352 patients, 199 patients presented with early-ISR, 153 patients with late-ISR. Concerning the primary endpoint, patients with early-DES-ISR as compared those with late-DES-ISR showed significant higher risk (25.9% vs. 17.0%; p = .04). In a multivariate analysis including diabetic status, clinical presentation, previous coronary bypass graft and diameter stenosis after DCB-treatment, the adjusted hazard ratio showed significant higher risk for MACE of early-DES-ISR as compared to late-DES-ISR (HR adj = 1.8, [95% CI = 1.1-3.0], p = .02).
CONCLUSION
Clinical outcome at 12 months after treatment of DES-ISR with DCB, showed significant higher clinical event rates in patients presenting with early DES restenosis, as compared with patients presenting with late DES restenosis.",2020,"Secondary endpoints included the incidence of death, myocardial infarction, TLR and target lesion thrombosis at 12 months after DCB treatment.
","['352 patients, 199 patients presented with early-ISR, 153 patients with late-ISR', 'early versus late occurring drug-eluting stent restenosis', 'patients presenting with early versus late DES-ISR undergoing treatment with drug-coated balloons (DCB', 'patients with DES-ISR assigned to treatment with']","['DCB', 'drug-coated balloon angioplasty']","['late DES-ISR', 'major adverse cardiac event (MACE), defined as the combined incidence of death, myocardial infarction and target lesion revascularization (TLR', 'diabetic status, clinical presentation, previous coronary bypass graft and diameter stenosis', 'incidence of death, myocardial infarction, TLR and target lesion thrombosis', 'time of occurrence of ISR', 'clinical event rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",352.0,0.166,"Secondary endpoints included the incidence of death, myocardial infarction, TLR and target lesion thrombosis at 12 months after DCB treatment.
","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cassese', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Erion', 'Initials': 'E', 'LastName': 'Xhepa', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Tölg', 'Affiliation': 'Herzzentrum der Segeberger Kliniken GmbH, Bad Segeberg, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Hoppmann', 'Affiliation': 'I. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Laugwitz', 'Affiliation': 'I. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Byrne', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kufner', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28638']
706,32408862,Comparison of C-MAC D-blade videolaryngoscope and McCoy laryngoscope efficacy for nasotracheal intubation in simulated cervical spinal injury: a prospective randomized comparative study.,"BACKGROUND
Immobilization with cervical spine worsens endotracheal intubation condition. Though various intubation devices have been demonstrated to perform well in oral endotracheal intubation, limited information is available concerning nasotracheal intubation (NTI) in patients with cervical spine immobilization. The present study compared the performance of the C-MAC D-Blade videolaryngoscope with the McCoy laryngoscope for NTI in patients with simulated cervical spine injuries.
METHODS
This was a prospective, randomized, controlled, study done in a tertiary hospital. Ninety-five patients requiring NTI were included in data analysis: McCoy group (group M, n = 47) or C-MAC D-Blade videolaryngoscope group (group C, n = 48). A Philadelphia neck collar was applied before anesthetic induction to immobilize the cervical spine. Single experienced anesthesiologist performed NTI. The primary outcome was duration of intubation divided by three steps: nose to oropharynx; oropharynx into glottic inlet; and glottic inlet to trachea. Secondary outcomes included glottic view as percentage of glottis opening (POGO) score and Cormack-Lehance (CL) grade, modified nasal intubation-difficulty scale (NIDS) rating, hemodynamic changes before and after intubation, and complications.
RESULTS
Total intubation duration was significantly shorter in group C (39.5 ± 11.4 s) compared to group M (48.1 ± 13.9 s). Group C required significantly less time for glottic visualization and endotracheal tube placement in the trachea. More patients in group C had CL grade I and higher POGO scores (P < 0.001, for both measures). No difficulty in NTI (modified NIDS = 0) was more in group C than group M. Hemodynamic changes and incidence of complications were comparable between groups.
CONCLUSION
The C-MAC D-Blade videolaryngoscope is an effective tool for NTI in a simulated difficult airway, which improves glottic visualization and shortens intubation time relative to those with McCoy laryngoscope.
TRIAL REGISTRATION
Clinical Research Information Service of the Korea National Institute of Health, Identification number: KCT 0004535, Registered December 10, 2019, Retrospectively registered, http://cris.nih.go.kr.",2020,"RESULTS
Total intubation duration was significantly shorter in group C (39.5 ± 11.4 s) compared to group M (48.1 ± 13.9 s).","['patients with simulated cervical spine injuries', 'Immobilization with cervical spine worsens endotracheal intubation condition', 'simulated cervical spinal injury', 'patients with cervical spine immobilization', 'Ninety-five patients requiring NTI were included in data analysis']","['nasotracheal intubation', 'C-MAC D-Blade videolaryngoscope with the McCoy laryngoscope for NTI', 'McCoy', 'C-MAC D-Blade videolaryngoscope group', 'C-MAC D-blade videolaryngoscope and McCoy laryngoscope efficacy']","['Hemodynamic changes and incidence of complications', 'duration of intubation divided by three steps', 'time for glottic visualization and endotracheal tube placement', 'CL grade', 'Total intubation duration', 'POGO scores', 'glottic view as percentage of glottis opening (POGO) score and Cormack-Lehance (CL) grade, modified nasal intubation-difficulty scale (NIDS) rating, hemodynamic changes before and after intubation, and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0432666', 'cui_str': 'Injury of cervical spine'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037937', 'cui_str': 'Spinal injury'}, {'cui': 'C1301792', 'cui_str': 'Cervical spine immobilization'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.119102,"RESULTS
Total intubation duration was significantly shorter in group C (39.5 ± 11.4 s) compared to group M (48.1 ± 13.9 s).","[{'ForeName': 'Kwon Hui', 'Initials': 'KH', 'LastName': 'Seo', 'Affiliation': 'Department of anesthesiology and pain medicine, Hallym University Sacred Heart Hospital, Hallym University School of Medicine, 22, Gwanpyeong-ro 170 beon-gil, Dong-gu, Anyang-si, Gyeonggi-do, 14068, Republic of Korea.'}, {'ForeName': 'Kyung Mi', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Clinical assistant professor, Department of anesthesiology and pain medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea. sumsonyo@gmail.com.'}, {'ForeName': 'Hyunji', 'Initials': 'H', 'LastName': 'John', 'Affiliation': 'Department of anesthesiology and pain medicine, Hallym University Sacred Heart Hospital, Hallym University School of Medicine, 22, Gwanpyeong-ro 170 beon-gil, Dong-gu, Anyang-si, Gyeonggi-do, 14068, Republic of Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Jun', 'Affiliation': 'Department of anesthesiology and pain medicine, Kangnam Sacred Heart Hospital, Hallym University School of Medicine, 12, Siheung-daero 187-gil, Yeongdeungpo-gu, Seoul, 07441, Republic of Korea.'}, {'ForeName': 'Minsoo', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Department of anesthesiology and pain medicine, Hallym University Sacred Heart Hospital, Hallym University School of Medicine, 22, Gwanpyeong-ro 170 beon-gil, Dong-gu, Anyang-si, Gyeonggi-do, 14068, Republic of Korea.'}, {'ForeName': 'Soyoun', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of anesthesiology and pain medicine, Hallym University Sacred Heart Hospital, Hallym University School of Medicine, 22, Gwanpyeong-ro 170 beon-gil, Dong-gu, Anyang-si, Gyeonggi-do, 14068, Republic of Korea.'}]",BMC anesthesiology,['10.1186/s12871-020-01021-x']
707,31543299,Clinical outcomes of adjunctive indocyanine green-diode lasers therapy for treating refractory periodontitis: A randomized controlled trial with in vitro assessment.,"BACKGROUND/PURPOSE
It is still challengeable to treat periodontal pockets refractory to mechanical debridement. This study is to evaluate the potential of indocyanine green (ICG)-diode laser-based photothermal therapy (PTT) for solving this dilemma.
METHODS
Bone marrow-derived mesenchymal stem cells (BMSCs) and periodontal ligament cells (PDLCs) were incubated with phosphate-buffered saline, chlorhexidine, or ICG, non-irradiated or irradiated with 810-nm diode lasers, and the cell viability was evaluated. Patients with teeth refractory to mechanical periodontal debridement on different quadrants were recruited. At baseline (T0), all examined teeth received scaling and root planing, and those on the test quadrant (PTT group) received ICG-diode laser treatment. The outcome was evaluated using clinical parameters and cytokines in the gingival crevicular fluids at 4-6 weeks (T1) and 6 months (T2).
RESULTS
In ICG-treated cultures, the viability of BMSCs and PDLCs was recovered on day 4, and laser irradiation inhibited the metabolic activities of BMSCs. 22 patients with 30 control teeth and 35 PTT-treated teeth were examined. All examined teeth showed modest reductions in probing pocket depth (PPD), clinical attachment loss (CAL), bleeding upon probing (BOP), and plaque score at T1 and T2 and significant reductions in IL-1β and MMP-8 at T2. Compared with controls, BOP was reduced more prominently, IL-1β and MMP-8 were significantly lower, and reductions in PPD and CAL were slightly greater in the PTT group at T1 (0.05-0.19 mm).
CONCLUSION
ICG-diode laser-based PTT is compatible to periodontium and assists in faster resolution of gingival inflammation in periodontal pockets refractory to mechanical debridement.",2020,"All examined teeth showed modest reductions in probing pocket depth (PPD), clinical attachment loss (CAL), bleeding upon probing (BOP), and plaque score at T1 and T2 and significant reductions in IL-1β and MMP-8 at T2.","['22 patients with 30 control teeth and 35 PTT-treated teeth were examined', 'Patients with teeth refractory to mechanical periodontal debridement on different quadrants were recruited', 'treating refractory periodontitis']","['ICG-diode laser treatment', 'indocyanine green (ICG)-diode laser-based photothermal therapy (PTT', 'adjunctive indocyanine green-diode lasers therapy', 'IL-1β', 'PTT', 'ICG-diode laser-based PTT', 'Bone marrow-derived mesenchymal stem cells (BMSCs) and periodontal ligament cells (PDLCs) were incubated with phosphate-buffered saline, chlorhexidine, or ICG, non-irradiated or irradiated with 810-nm diode lasers']","['probing pocket depth (PPD), clinical attachment loss (CAL), bleeding upon probing (BOP), and plaque score', 'clinical parameters and cytokines in the gingival crevicular fluids', 'IL-1β and MMP-8', 'metabolic activities of BMSCs', 'viability of BMSCs and PDLCs', 'BOP', 'PPD and CAL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C2936227', 'cui_str': 'Nonsurgical Periodontal Debridement'}, {'cui': 'C0399448', 'cui_str': 'Refractory periodontitis (disorder)'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}, {'cui': 'C0031093', 'cui_str': 'Alveolodental Membrane'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]","[{'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]",,0.0448371,"All examined teeth showed modest reductions in probing pocket depth (PPD), clinical attachment loss (CAL), bleeding upon probing (BOP), and plaque score at T1 and T2 and significant reductions in IL-1β and MMP-8 at T2.","[{'ForeName': 'Chun-Pin', 'Initials': 'CP', 'LastName': 'Chiang', 'Affiliation': 'Department of Dentistry, Far Eastern Memorial Hospital, New Taipei City, Taiwan; Graduate Institute of Oral Biology, School of Dentistry, National Taiwan University, Taipei, Taiwan; Department of Dentistry, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Hsieh', 'Affiliation': 'Graduate Institute of Clinical Dentistry, School of Dentistry, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chiu', 'Initials': 'WC', 'LastName': 'Tai', 'Affiliation': 'Graduate Institute of Clinical Dentistry, School of Dentistry, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Yi-Jane', 'Initials': 'YJ', 'LastName': 'Chen', 'Affiliation': 'Department of Dentistry, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Clinical Dentistry, School of Dentistry, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Po-Chun', 'Initials': 'PC', 'LastName': 'Chang', 'Affiliation': 'Department of Dentistry, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Clinical Dentistry, School of Dentistry, National Taiwan University, Taipei, Taiwan. Electronic address: changpc@ntu.edu.tw.'}]",Journal of the Formosan Medical Association = Taiwan yi zhi,['10.1016/j.jfma.2019.08.021']
708,29866165,FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): a multicentre pilot randomised controlled trial of high-flow nasal cannula therapy versus continuous positive airway pressure in paediatric critical care.,"BACKGROUND
Although high-flow nasal cannula therapy (HFNC) has become a popular mode of non-invasive respiratory support (NRS) in critically ill children, there are no randomised controlled trials (RCTs) comparing it with continuous positive airway pressure (CPAP). We performed a pilot RCT to explore the feasibility, and inform the design and conduct, of a future large pragmatic RCT comparing HFNC and CPAP in paediatric critical care.
METHODS
In this multi-centre pilot RCT, eligible patients were recruited to either Group A (step-up NRS) or Group B (step-down NRS). Participants were randomised (1:1) using sealed opaque envelopes to either CPAP or HFNC as their first-line mode of NRS. Consent was sought after randomisation in emergency situations. The primary study outcomes were related to feasibility (number of eligible patients in each group, proportion of eligible patients randomised, consent rate, and measures of adherence to study algorithms). Data were collected on safety and a range of patient outcomes in order to inform the choice of a primary outcome measure for the future RCT.
RESULTS
Overall, 121/254 eligible patients (47.6%) were randomised (Group A 60%, Group B 44.2%) over a 10-month period (recruitment rate for Group A, 1 patient/site/month; Group B, 2.8 patients/site/month). In Group A, consent was obtained in 29/33 parents/guardians approached (87.9%), while in Group B 84/118 consented (71.2%). Intention-to-treat analysis included 113 patients (HFNC 59, CPAP 54). Most reported adverse events were mild/moderate (HFNC 8/59, CPAP 9/54). More patients switched treatment from HFNC to CPAP (Group A: 7/16, 44%; Group B: 9/43, 21%) than from CPAP to HFNC (Group A: 3/13, 23%; Group B: 5/41, 12%). Intubation occurred within 72 h in 15/59 (25.4%) of HFNC patients and 10/54 (18.5%) of CPAP patients (p = 0.38). HFNC patients experienced fewer ventilator-free days at day 28 (Group A: 19.6 vs. 23.5; Group B: 21.8 vs. 22.2).
CONCLUSIONS
Our pilot trial confirms that, following minor changes to consent procedures and treatment algorithms, it is feasible to conduct a large national RCT of non-invasive respiratory support in the paediatric critical care setting in both step-up and step-down NRS patients.
TRIAL REGISTRATION
clinicaltrials.gov, NCT02612415 . Registered on 23 November 2015.",2018,Intubation occurred within 72 h in 15/59 (25.4%) of HFNC patients and 10/54 (18.5%) of CPAP patients (p = 0.38).,"['paediatric critical care', '113 patients (HFNC 59, CPAP 54', 'Children (FIRST-ABC', 'critically ill children']","['HFNC to CPAP', 'HFNC', 'CPAP or HFNC', 'high-flow nasal cannula therapy', 'high-flow nasal cannula therapy (HFNC']","['adverse events', 'Intubation']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0010337', 'cui_str': 'Critical Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",,0.227629,Intubation occurred within 72 h in 15/59 (25.4%) of HFNC patients and 10/54 (18.5%) of CPAP patients (p = 0.38).,"[{'ForeName': 'Padmanabhan', 'Initials': 'P', 'LastName': 'Ramnarayan', 'Affiliation': ""Children's Acute Transport Service, Critical Care Division, Great Ormond Street Hospital NHS Foundation Trust, 26-27 Boswell Street, London, WC1N 3JZ, UK. p.ramnarayan@gosh.nhs.uk.""}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Lister', 'Affiliation': 'Paediatric and Neonatal Intensive Care Unit, Critical Care Division, Great Ormond Street Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Dominguez', 'Affiliation': 'Cardiac Intensive Care Unit, Critical Care Division, Great Ormond Street Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Habibi', 'Affiliation': ""Paediatric Intensive Care Unit, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.""}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Edmonds', 'Affiliation': 'Paediatric Critical Care Unit, Royal London Hospital, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Ruth R', 'Initials': 'RR', 'LastName': 'Canter', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, High Holborn, London, UK.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Wulff', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, High Holborn, London, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, High Holborn, London, UK.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, High Holborn, London, UK.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Peters', 'Affiliation': 'Paediatric and Neonatal Intensive Care Unit, Critical Care Division, Great Ormond Street Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Critical care (London, England)",['10.1186/s13054-018-2080-3']
709,31677386,Early Vaccination With Bacille Calmette-Guérin-Denmark or BCG-Japan Versus BCG-Russia to Healthy Newborns in Guinea-Bissau: A Randomized Controlled Trial.,"BACKGROUND
Bacille Calmette-Guérin (BCG) vaccination remains a cornerstone against tuberculosis. Randomized controlled trials (RCTs) have demonstrated that BCG-Denmark lowers all-cause mortality, but a recent RCT found no effect of BCG-Russia. Observational studies indicate that the genetically divergent BCG strains have different effects.
METHODS
This was a parallel-group, open-label RCT conducted at the National Hospital in Guinea-Bissau. Healthy neonates were randomized 1:1 to BCG-Denmark (2851 randomized, 2840 analyzed) vs BCG-Russia (2845 randomized, 2837 analyzed). We hypothesized that BCG-Denmark would reduce morbidity (primary outcome) and mortality while inducing more BCG reactions and purified protein derivative (PPD) responses (secondary outcomes). Halfway through the trial, production of BCG-Denmark was halted, and the trial continued comparing BCG-Japan (3191 neonates randomized, 3184 analyzed) with BCG-Russia (3170 randomized, 3160 analyzed). Mortality and morbidity data were collected by telephone, at home visits, and at the National Hospital and assessed in Cox models providing 6-week mortality rate ratios (MRRs) and hospitalization incidence rate ratios (IRRs).
RESULTS
By age 6 weeks, there were 140 and 130 admissions among neonates vaccinated with BCG-Denmark and BCG-Russia, respectively (IRR, 1.08 [95% confidence interval {CI}, .84-1.37]). For BCG-Japan, there were 185 admissions vs 161 admissions for BCG-Russia (IRR, 1.15 [95% CI, .93-1.43]). The 6-week mortality did not differ: BCG-Denmark/BCG-Russia (MRR, 1.15 [95% CI, .74-1.80]); BCG-Japan/BCG-Russia (MRR, 0.71 [95% CI, .43-1.19]). BCG-Denmark and BCG-Japan induced more BCG scars and PPD reactions than BCG-Russia.
CONCLUSIONS
BCG strains did not affect morbidity. BCG-Denmark and BCG-Japan were more immunogenic than BCG-Russia by the measures traditionally viewed as surrogates for successful immunization. The implications of strain differences for tuberculosis protection and overall health warrant further study.
CLINICAL TRIALS REGISTRATION
NCT02447536.",2020,BCG-Denmark and BCG-Japan were more immunogenic than BCG-Russia by the measures traditionally viewed as surrogates for successful immunization.,"['3,191 neonates randomized, 3,184 analyzed) with BCG-Russia (3,170 randomized, 3,160 analyzed', 'Parallel-group, open-label RCT conducted at the National Hospital in Guinea-Bissau', 'neonates vaccinated with BCG-Denmark and 130 admissions for BCG-Russia, IRR=1.08', 'Healthy neonates', 'healthy newborns in Guinea-Bissau']","['BCG-Denmark or BCG-Japan versus BCG-Russia', 'Bacille Calmette-Guérin (BCG) vaccination', 'BCG-Denmark', 'BCG-Japan', 'BCG-Russia']","['BCG scars and PPD reactions', 'BCG reactions and Purified Protein Derivative (PPD) responses', 'morbidity', 'Mortality and morbidity data', '6-week mortality', 'Mortality Rate Ratios (MRRs) and hospitalization Incidence Rate Ratios (IRRs']","[{'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0018387', 'cui_str': 'Portuguese Guinea'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0578757', 'cui_str': 'Good neonatal condition at birth (finding)'}]","[{'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",2845.0,0.101812,BCG-Denmark and BCG-Japan were more immunogenic than BCG-Russia by the measures traditionally viewed as surrogates for successful immunization.,"[{'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Schaltz-Buchholzer', 'Affiliation': 'Institute of Clinical Research, University of Southern Denmark and Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Bjerregaard-Andersen', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.'}, {'ForeName': 'Christian Bjerregård', 'Initials': 'CB', 'LastName': 'Øland', 'Affiliation': 'Research Center for Vitamins and Vaccines, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Golding', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.'}, {'ForeName': 'Elise Brenno', 'Initials': 'EB', 'LastName': 'Stjernholm', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Monteiro', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Aaby', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.'}, {'ForeName': 'Christine Stabell', 'Initials': 'CS', 'LastName': 'Benn', 'Affiliation': 'Institute of Clinical Research, University of Southern Denmark and Odense University Hospital, Odense, Denmark.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1080']
710,30598484,"Preventing PTSD, depression and associated health problems in student paramedics: protocol for PREVENT-PTSD, a randomised controlled trial of supported online cognitive training for resilience versus alternative online training and standard practice.","INTRODUCTION
Emergency workers dedicate their lives to promoting public health and safety, yet suffer higher rates of post-traumatic stress disorder (PTSD) and major depression (MD) compared with the general population. They also suffer an associated increased risk for physical health problems, which may be linked to specific immunological and endocrine markers or changes in relevant markers. Poor physical and mental health is costly to organisations, the National Health Service and society. Existing interventions aimed at reducing risk of mental ill health in this population are not very successful. More effective preventative interventions are urgently needed. We first conducted a large-scale prospective study of newly recruited student paramedics, identifying two cognitive factors (rumination and resilience appraisals) that predicted episodes of PTSD and MD over a 2-year period. We then developed internet-delivered cognitive training for resilience (iCT-R), a supported online intervention, to modify cognitive predictors. This protocol is for a randomised controlled trial to evaluate the efficacy of the resilience intervention.
METHODS AND ANALYSIS
570 student paramedics will be recruited from participating universities. They will be randomly allocated to iCT-R or to supported online training of an alternative, widely available intervention or to training-as-usual. Follow-up will occur after the intervention/standard practice period and at 6, 12 and 24 months. Primary outcomes include rates of PTSD and MD and subsydnromal PTSD and MD, measured by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fifth edition, the Patient-Health Questionnaire-9 and the Post-traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, fifth edition. Secondary outcomes include measures of resilience, rumination, anxiety, psychological distress, well-being, salivary cortisol, plasma levels of C-reactive protein, smoking and alcohol use, weight gain, sleep problems, health-related quality of life, health resource utilisation and productivity.
ETHICS AND DISSEMINATION
The Medical Sciences Inter-Divisional Research Ethics Committee at the University of Oxford granted approval, reference: R44116/RE001. The results will be published in a peer-reviewed journal. Access to raw data and participant information will be available only to members of the research team.
TRIAL REGISTRATION NUMBER
ISRCTN16493616; Pre-results.",2018,"We then developed internet-delivered cognitive training for resilience (iCT-R), a supported online intervention, to modify cognitive predictors.","['newly recruited student paramedics, identifying two cognitive factors (rumination and resilience appraisals) that predicted episodes of PTSD and MD over a 2-year period', '570 student paramedics will be recruited from participating universities']","['internet-delivered cognitive training for resilience (iCT-R', 'online cognitive training']","['measures of resilience, rumination, anxiety, psychological distress, well-being, salivary cortisol, plasma levels of C-reactive protein, smoking and alcohol use, weight gain, sleep problems, health-related quality of life, health resource utilisation and productivity', 'PTSD, depression and associated health problems', 'rates of PTSD and MD and subsydnromal PTSD and MD, measured by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fifth edition, the Patient-Health Questionnaire-9 and the Post-traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, fifth edition']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0030450', 'cui_str': 'Paramedics'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",,0.0608546,"We then developed internet-delivered cognitive training for resilience (iCT-R), a supported online intervention, to modify cognitive predictors.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wild', 'Affiliation': 'Department of Experimental Psychology, Oxford Centre for Anxiety Disorders and Trauma, University of Oxford, Oxford, UK.'}, {'ForeName': 'Shama', 'Initials': 'S', 'LastName': 'El-Salahi', 'Affiliation': 'Department of Experimental Psychology, Oxford Centre for Anxiety Disorders and Trauma, University of Oxford, Oxford, UK.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Tyson', 'Affiliation': 'Department of Experimental Psychology, Oxford Centre for Anxiety Disorders and Trauma, University of Oxford, Oxford, UK.'}, {'ForeName': 'Hjördis', 'Initials': 'H', 'LastName': 'Lorenz', 'Affiliation': 'Department of Experimental Psychology, Oxford Centre for Anxiety Disorders and Trauma, University of Oxford, Oxford, UK.'}, {'ForeName': 'Carmine M', 'Initials': 'CM', 'LastName': 'Pariante', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Danese', 'Affiliation': ""Department of Social, Genetic and Developmental Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Tsiachristas', 'Affiliation': 'Nuffield Department of Population Health, Health Economics Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Watkins', 'Affiliation': 'Sir Henry Wellcome Building for Mood Disorders Research, School of Psychology College of Life and Environmental Sciences, University of Exeter, Exeter, UK.'}, {'ForeName': 'Benita', 'Initials': 'B', 'LastName': 'Middleton', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Surrey, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Blaber', 'Affiliation': 'School of Health Sciences, University of Brighton, Brighton, UK.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Ehlers', 'Affiliation': 'Department of Experimental Psychology, Oxford Centre for Anxiety Disorders and Trauma, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2018-022292']
711,31589323,Combination Lorcaserin and Nicotine Patch for Smoking Cessation Without Weight Gain.,"INTRODUCTION
This study explored the efficacy of combination lorcaserin and nicotine patch for smoking cessation treatment and prevention of postsmoking cessation weight gain.
METHODS
We conducted a trial in which 61 adult daily smokers were asked to quit smoking using a combination of lorcaserin and nicotine patch. During the first 2 weeks of treatment prior to the quit day, participants were randomized to receive either lorcaserin (10 mg twice daily) plus nicotine patch (21 mg) or placebo plus nicotine patch (21 mg). Following this 2-week period, participants received both medications for 12 weeks. Outcomes included 4-week continuous smoking abstinence at the end of treatment (weeks 7-10 postquit attempt), weight change, ad libitum smoking, withdrawal symptoms, and ratings of cigarette reward.
RESULTS
Biochemically confirmed continuous smoking abstinence from 7 to 10 weeks postquit attempt was 31.1% (90% confidence interval, 21.4%-40.8%). Participants who quit smoking showed no weight gain; in fact, mean weight change was minus 0.16 kg (SD = 3.27) over the study period. There was an unexpected but strong association (p = .006) between a decrease in sensory enjoyment of smoking and successful quit outcome on this regimen. During the prequit randomization period, lorcaserin versus placebo reduced the impact of smoking to relieve craving for cigarettes as well as the sensory enjoyment of smoking (p = .005). Adherence and tolerability to lorcaserin and nicotine patch was good.
CONCLUSIONS
The combination of lorcaserin and nicotine patch was well tolerated, associated with a relatively high smoking abstinence rate, and effectively prevented weight gain associated with quitting smoking.
IMPLICATIONS
This report provides an important contribution to the literature because it details evidence of a medication combination-lorcaserin and nicotine-that is effective for smoking cessation and for ameliorating weight gain associated with smoking cessation. For many smokers, postcessation weight gain is a major obstacle to quitting, and this medication combination provides a suitable treatment option for these smokers.
CLINICAL TRIAL REGISTRATION
NCT02906644.",2020,There was an unexpected but strong association (p = .006) between a decrease in sensory enjoyment of smoking and successful quit outcome on this regimen.,"['Smoking Cessation Without Weight Gain', '61 adult daily smokers']","['lorcaserin versus placebo', 'lorcaserin', 'placebo plus nicotine patch', 'lorcaserin and nicotine patch', 'combination lorcaserin and nicotine patch', 'quit smoking using a combination of lorcaserin and nicotine patch', 'Combination Lorcaserin and Nicotine Patch', 'nicotine patch']","['sensory enjoyment of smoking and successful quit outcome', 'mean weight change', '4-week continuous smoking abstinence', 'weight change, ad libitum smoking, withdrawal symptoms, and ratings of cigarette reward', 'Adherence and tolerability', 'continuous smoking abstinence', 'weight gain']","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C2350948', 'cui_str': 'lorcaserin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",61.0,0.0300442,There was an unexpected but strong association (p = .006) between a decrease in sensory enjoyment of smoking and successful quit outcome on this regimen.,"[{'ForeName': 'Jed E', 'Initials': 'JE', 'LastName': 'Rose', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Division of Internal Medicine, Department of Medicine, Duke University, Durham, NC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz149']
712,31665279,Vacuum-formed retainer versus bonded retainer for dental stabilization in the mandible-a randomized controlled trial. Part I: retentive capacity 6 and 18 months after orthodontic treatment.,"BACKGROUND
Evidence concerning the most appropriate retention strategy after orthodontic treatment is still inconclusive.
OBJECTIVE
This trial compares the retentive capacity of vacuum-formed Essix C-retainers (VFR) and bonded cuspid-to-cuspid retainers (CTC) in the mandible 6 and 18 months after orthodontic treatment.
TRIAL DESIGN
A single-centre two-arm parallel-group randomized controlled trial.
METHODS
This study included 104 adolescent patients, computer-generated randomized with sequentially numbered, opaque, and sealed envelopes into two groups and stratified by gender (52 females and 52 males). The patients were treated with fixed appliances with and without tooth extractions in both jaws and were ready for debond. In the intervention arm, patients received a VFR (n = 52); in the active comparator arm, patients received a CTC (n = 52). Dental casts were obtained at debond (T1), after 6 months (T2), and after 18 months (T3). The casts were digitized. The retentive capacity was evaluated on digital three-dimensional models using Little's Irregularity Index (LII), overbite, overjet, arch length, and intermolar and intercanine width.
RESULTS
Baseline values were similar for both groups. Statistically significant increases were noted in LII and overbite, mainly between T1 and T2, but also between T1 and T3 in the VFR group (LII = 0.52 mm, P < 0.001, overbite = 0.51 mm, P < 0.001) and in the CTC group (LII = 0.45 mm P < 0.001, overbite = 0.36 mm, P < 0.001). There were no significant differences between groups. Overjet showed small variations during the observation periods but was overall stable within and between groups after 18 months. Arch length decreased slightly in both groups after 6 and 18 months. Intermolar and intercanine widths remained stable after debond.
LIMITATIONS
Patients, operator, and outcome assessor could not be blinded due to the study design.
CONCLUSIONS
VFR and CTC have the same retention capacity in the mandible after 6 and 18 months. Relapse mainly occurs during the first 6 months of retention, but the post-treatment changes are generally small. Shorter VFRs in the mandible do not cause negative vertical effects. Part-time wear regimen is not associated with increased relapse.
TRIAL REGISTRATION
NCT03070444.",2020,"Statistically significant increases were noted in LII and overbite, mainly between T1 and T2, but also between T1 and T3 in the VFR group (LII = 0.52 mm, P < 0.001, overbite = 0.51 mm, P < 0.001) and in the CTC group (LII = 0.45 mm P < 0.001, overbite = 0.36 mm, P < 0.001).","['104 adolescent patients, computer-generated randomized with sequentially numbered, opaque, and sealed envelopes into two groups and stratified by gender (52 females and 52 males']","['vacuum-formed Essix C-retainers (VFR) and bonded cuspid-to-cuspid retainers (CTC', 'CTC', 'fixed appliances with and without tooth extractions', 'Vacuum-formed retainer versus bonded retainer', 'VFR']","['Arch length', 'LII and overbite', 'Irregularity Index (LII), overbite, overjet, arch length, and intermolar and intercanine width', 'retentive capacity']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261286', 'cui_str': 'Opaque (qualifier value)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C4551580', 'cui_str': 'Retainer (attribute)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0010482', 'cui_str': 'Canine Tooth'}, {'cui': 'C0441421', 'cui_str': 'Permanent Retainer'}, {'cui': 'C0040440', 'cui_str': 'Tooth Extraction'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1305740', 'cui_str': 'Over Bite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0596028', 'cui_str': 'Overjet, Dental'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}]",104.0,0.196485,"Statistically significant increases were noted in LII and overbite, mainly between T1 and T2, but also between T1 and T3 in the VFR group (LII = 0.52 mm, P < 0.001, overbite = 0.51 mm, P < 0.001) and in the CTC group (LII = 0.45 mm P < 0.001, overbite = 0.36 mm, P < 0.001).","[{'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Krämer', 'Affiliation': 'Orthodontic Clinic, Public Dental Health, Region Gävleborg.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Sjöström', 'Affiliation': 'Oral and Maxillofacial Surgery, Department of Odontology, Umeå University, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hallman', 'Affiliation': 'Centre for Research and Development, Uppsala University, Region Gävleborg.'}, {'ForeName': 'Ingalill', 'Initials': 'I', 'LastName': 'Feldmann', 'Affiliation': 'Orthodontic Clinic, Public Dental Health, Region Gävleborg.'}]",European journal of orthodontics,['10.1093/ejo/cjz072']
713,30365470,Cold-Water Immersion Has No Effect on Muscle Stiffness After Exercise-Induced Muscle Damage.,"OBJECTIVE
To analyze the effect of cryotherapy on muscle stiffness after exercise-induced muscle damage.
DESIGN
A leg-to-leg comparison model.
SETTING
University research laboratory.
PARTICIPANTS
Thirty (30) untrained men (21.1 ± 1.6 years, 177.6 ± 6.4 cm, 75.9 ± 10.0 kg, and 15.9 ± 2.9% fat mass) with no history of lower-limb injury and no experience in resistance training.
INTERVENTION
All participants underwent a plyometric exercise program to induce muscle damage; however, randomly, one leg was assigned to a treatment condition and subjected twice to cold-water immersion of the lower limb at 10°C (±1°C) for 10 minutes, while the other leg was assigned to control.
MAIN OUTCOMES MEASURES
Longitudinal stiffness and passive transverse stiffness were evaluated on the soleus and gastrocnemius muscles at 4 moments: pre-exercise, immediately after exercise, 24 hours, and 72 hours after the damage protocol. Furthermore, pressure pain threshold (PPT) and maximal voluntary isometric contraction (MVIC) were also assessed in the same periods.
RESULTS
No significant differences between control and cryotherapy were observed in regard to MVIC (P = 0.529), passive longitudinal stiffness (P = 0.315), and passive transverse stiffness (P = 0.218). Only a significant decrease was observed in PPT on the soleus muscle in the cryotherapy compared with the control leg immediately after exercise (P = 0.040).
CONCLUSIONS
The results show that cryotherapy had no influence on muscle stiffness. However, cryotherapy had a positive effect on PPT immediately after exercise.",2020,"No significant differences between control and cryotherapy were observed in regard to MVIC (P = 0.529), passive longitudinal stiffness (P = 0.315), and passive transverse stiffness (P = 0.218).","['University research laboratory', 'Thirty (30) untrained men (21.1 ± 1.6 years, 177.6 ± 6.4 cm, 75.9 ± 10.0 kg, and 15.9 ± 2.9% fat mass) with no history of lower-limb injury and no experience in resistance training']","['cryotherapy', 'plyometric exercise program', 'Cold-Water Immersion']","['Furthermore, pressure pain threshold (PPT) and maximal voluntary isometric contraction (MVIC', 'soleus and gastrocnemius muscles at 4 moments: pre-exercise', 'muscle stiffness', 'passive longitudinal stiffness', 'Muscle Stiffness', 'passive transverse stiffness', 'PPT on the soleus muscle', 'Longitudinal stiffness and passive transverse stiffness']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0035168'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius Muscle'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0242694', 'cui_str': 'Soleus Muscle'}]",,0.0135538,"No significant differences between control and cryotherapy were observed in regard to MVIC (P = 0.529), passive longitudinal stiffness (P = 0.315), and passive transverse stiffness (P = 0.218).","[{'ForeName': 'João', 'Initials': 'J', 'LastName': 'Pinto', 'Affiliation': 'CESPU, Department of Physiotherapy, North Polytechnic Institute of Health, Paredes, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Rocha', 'Affiliation': 'CESPU, Department of Physiotherapy, North Polytechnic Institute of Health, Paredes, Portugal.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Torres', 'Affiliation': 'CESPU, Department of Physiotherapy, North Polytechnic Institute of Health, Paredes, Portugal.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000682']
714,16505753,Significance of patient-controlled sedation during colonoscopy. Results from a prospective randomized controlled study.,"BACKGROUND
In France, general anesthesia is given to more than 90% of patients undergoing colonoscopy although in several countries sedation is limited to intolerant patients. This study was carried out to determine whether Patient-Controlled Sedation (PCS) could provide a lighter sedation than general anesthesia adapted to the patient's individual requirement.
METHODS
Patients aged from 18 to 80 scheduled for elective colonoscopy were prospectively randomized to receive either standard sedation (control group) or patient-controlled-sedation (PCS). In the control group, patients received a continuous infusion of propofol. Patients in the PCS group were connected to an infusion pump containing propofol and self-administered 20-mg boluses as often as they required. An anesthetist was present throughout the procedure. Patient satisfaction measured on a visual analog scale four hours after colonoscopy was the main outcome criterion.
RESULTS
From December 2002 to September 2003, 402 patients underwent elective colonoscopy, 173 of them were eligible and were asked to participate in the study. Seventy-two gave their informed consent and were prospectively randomized. The patients' mean satisfaction scores were not statistically different between the two groups: 84.7 mm (PCS group) vs. 91.5 mm (control group); P = 0.24. Mean doses of propofol (60 mg vs. 248 mg; P <0.001), depth of sedation and time before discharge (1.75 hours vs. 4.45 hours) were significantly lower for patients in the PCS group; nine of them (25.7%) did not use the pump and had total colonoscopy without sedation. There were no statistically significant differences between the two groups regarding total duration of colonoscopy (19.4 min (PCS) vs. 18 min (control)) difficulty and therapeutic procedures (biopsy or polypectomy). Two weeks after the procedure, 96.5% of patients in the PCS group were willing to repeat the examination under the same conditions vs. 72.5% of patients in the control group (P = 0.03).
CONCLUSIONS
Our results demonstrate that need of sedation is widely overestimated in France. A subset of our patients is willing to consider colonoscopy without general anesthesia. For them, PCS with propofol is an effective and very well accepted form of sedation.",2005,"Mean doses of propofol (60 mg vs. 248 mg; P <0.001), depth of sedation and time before discharge (1.75 hours vs. 4.45 hours) were significantly lower for patients in the PCS group; nine of them (25.7%) did not use the pump and had total colonoscopy without sedation.","['From December 2002 to September 2003, 402 patients underwent elective colonoscopy, 173 of them were eligible and were asked to participate in the study', 'Patients aged from 18 to 80 scheduled for elective colonoscopy', 'patient-controlled sedation during colonoscopy', 'Seventy-two gave their informed consent and were prospectively randomized']","['propofol', 'standard sedation (control group) or patient-controlled-sedation (PCS', 'Patient-Controlled Sedation (PCS', 'PCS']","['visual analog scale', 'Patient satisfaction', 'mean satisfaction scores', 'total duration of colonoscopy', 'depth of sedation and time before discharge']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",,0.0330732,"Mean doses of propofol (60 mg vs. 248 mg; P <0.001), depth of sedation and time before discharge (1.75 hours vs. 4.45 hours) were significantly lower for patients in the PCS group; nine of them (25.7%) did not use the pump and had total colonoscopy without sedation.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Crepeau', 'Affiliation': ""Service d'Hépato-gastroentérologie, Hôtel-Dieu. thomas.crepeau@wanadoo""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Poincloux', 'Affiliation': ''}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Bonny', 'Affiliation': ''}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Lighetto', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Jaffeux', 'Affiliation': ''}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Artigue', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Walleckx', 'Affiliation': ''}, {'ForeName': 'Jean Etienne', 'Initials': 'JE', 'LastName': 'Bazin', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Dapoigny', 'Affiliation': ''}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Bommelaer', 'Affiliation': ''}]",Gastroenterologie clinique et biologique,[]
715,30361325,DUET: A Phase 2 Study Evaluating the Efficacy and Safety of Sparsentan in Patients with FSGS.,"BACKGROUND
We evaluated and compared the effects of sparsentan, a dual endothelin type A (ET A ) and angiotensin II type 1 receptor antagonist, with those of the angiotensin II type 1 receptor antagonist irbesartan in patients with primary FSGS.
METHODS
In this phase 2, randomized, double-blind, active-control Efficacy and Safety of Sparsentan (RE-021), a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients with Focal Segmental Glomerulosclerosis (FSGS): A Randomized, Double-blind, Active-Control, Dose-Escalation Study (DUET), patients aged 8-75 years with biopsy-proven FSGS, eGFR>30 ml/min per 1.73 m 2 , and urinary protein-to-creatinine ratio (UP/C) ≥1.0 g/g received sparsentan (200, 400, or 800 mg/d) or irbesartan (300 mg/d) for 8 weeks, followed by open-label sparsentan only. End points at week 8 were reduction from baseline in UP/C (primary) and proportion of patients achieving FSGS partial remission end point (FPRE) (UP/C: ≤1.5 g/g and >40% reduction [secondary]).
RESULTS
Of 109 patients randomized, 96 received study drugs and had baseline and week 8 UP/C measurements. Sparsentan-treated patients had greater reductions in UP/C than irbesartan-treated patients did when all doses (45% versus 19%; P =0.006) or the 400 and 800 mg doses (47% versus 19%; P =0.01) were pooled for analysis. The FSGS partial remission end point was achieved in 28% of sparsentan-treated and 9% of irbesartan-treated patients ( P =0.04). After 8 weeks of treatment, BP was reduced with sparsentan but not irbesartan, and eGFR was stable with both treatments. Overall, the incidence of adverse events was similar between groups. Hypotension and edema were more common among sparsentan-treated patients but did not result in study withdrawals.
CONCLUSIONS
Patients with FSGS achieved significantly greater reductions in proteinuria after 8 weeks of sparsentan versus irbesartan. Sparsentan was safe and well tolerated.",2018,"After 8 weeks of treatment, BP was reduced with sparsentan but not irbesartan, and eGFR was stable with both treatments.","['Patients with Focal Segmental Glomerulosclerosis (FSGS', 'Patients with FSGS', 'patients aged 8-75 years with biopsy-proven FSGS, eGFR>30 ml/min per 1.73 m 2 , and urinary protein-to-creatinine ratio (UP/C', '109 patients randomized, 96 received study drugs and had baseline and week 8 UP/C measurements', 'patients with primary FSGS']","['sparsentan', 'Sparsentan (RE-021), a Dual Endothelin Receptor and Angiotensin Receptor Blocker', 'irbesartan', 'DUET']","['safe and well tolerated', 'proteinuria', 'Hypotension and edema', 'BP', 'FSGS partial remission end point', 'incidence of adverse events', 'FSGS partial remission end point (FPRE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017668', 'cui_str': 'Glomerulonephritis, Focal Sclerosing'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0059285', 'cui_str': 'Endothelin Receptor'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C0288171', 'cui_str': 'irbesartan'}]","[{'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",109.0,0.251666,"After 8 weeks of treatment, BP was reduced with sparsentan but not irbesartan, and eGFR was stable with both treatments.","[{'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Trachtman', 'Affiliation': 'Division of Pediatric Nephrology, Department of Pediatrics, New York University School of Medicine, Langone Medical Center, New York, New York; howard.trachtman@nyumc.org radko.komers@retrophin.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nelson', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, University of Washington, Seattle, Washington.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Adler', 'Affiliation': 'Division of Nephrology and Hypertension, Los Angeles Biomedical Research Institute at Harbor-University of California, Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Kirk N', 'Initials': 'KN', 'LastName': 'Campbell', 'Affiliation': 'Division of Nephrology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Abanti', 'Initials': 'A', 'LastName': 'Chaudhuri', 'Affiliation': 'Division of Pediatric Nephrology, Stanford University, Palo Alto, California.'}, {'ForeName': 'Vimal Kumar', 'Initials': 'VK', 'LastName': 'Derebail', 'Affiliation': 'Division of Nephrology and Hypertension, University of North Carolina Kidney Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Gambaro', 'Affiliation': 'Division of Nephrology and Dialysis, Università Cattolica del Sacro Cuore, Fondazione Policlinico A. Gemelli, Rome, Italy.'}, {'ForeName': 'Loreto', 'Initials': 'L', 'LastName': 'Gesualdo', 'Affiliation': 'Nephrology Unit, Department of Emergency and Organ Transplantation (DETO), Azienda Ospedaliero Universitaria Policlinico di Bari, Bari, Italy.'}, {'ForeName': 'Debbie S', 'Initials': 'DS', 'LastName': 'Gipson', 'Affiliation': 'Division of Pediatric Nephrology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hogan', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Lieberman', 'Affiliation': ""Department of Pediatric Nephrology, Joseph M. Sanzari Children's Hospital, Hackensack University Medical Center, Hackensack, New Jersey.""}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Marder', 'Affiliation': 'Division of Transplant Research, Colorado Kidney Care, Denver, Colorado.'}, {'ForeName': 'Kevin Edward', 'Initials': 'KE', 'LastName': 'Meyers', 'Affiliation': ""Division of Nephrology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Mustafa', 'Affiliation': 'Department of Nephrology and Research Division, Arizona Kidney Disease and Hypertension Center, Phoenix, Arizona.'}, {'ForeName': 'Jai', 'Initials': 'J', 'LastName': 'Radhakrishnan', 'Affiliation': 'Division of Nephrology, Columbia University, New York, New York.'}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Srivastava', 'Affiliation': ""Children's Mercy Hospital, Kansas City, Missouri.""}, {'ForeName': 'Miganush', 'Initials': 'M', 'LastName': 'Stepanians', 'Affiliation': 'PROMETRIKA, LLC., Cambridge, Massachusetts.'}, {'ForeName': 'Vladimír', 'Initials': 'V', 'LastName': 'Tesar', 'Affiliation': 'Department of Nephrology, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Zhdanova', 'Affiliation': 'Division of Nephrology, New York University School of Medicine, New York, New York; and.'}, {'ForeName': 'Radko', 'Initials': 'R', 'LastName': 'Komers', 'Affiliation': 'Department of Research & Development, Retrophin, Inc., San Diego, California howard.trachtman@nyumc.org radko.komers@retrophin.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2018010091']
716,30380038,A Balanced Proinflammatory and Regulatory Cytokine Signature in Young African Children Is Associated With Lower Risk of Clinical Malaria.,"BACKGROUND
The effect of timing of exposure to first Plasmodium falciparum infections during early childhood on the induction of innate and adaptive cytokine responses and their contribution to the development of clinical malaria immunity is not well established.
METHODS
As part of a double-blind, randomized, placebo-controlled trial in Mozambique using monthly chemoprophylaxis with sulfadoxine-pyrimethamine plus artesunate to selectively control timing of malaria exposure during infancy, peripheral blood mononuclear cells collected from participants at age 2.5, 5.5, 10.5, 15, and 24 months were stimulated ex vivo with parasite schizont and erythrocyte lysates. Cytokine messenger RNA expressed in cell pellets and proteins secreted in supernatants were quantified by reverse-transcription quantitative polymerase chain reaction and multiplex flow cytometry, respectively. Children were followed up for clinical malaria from birth until 4 years of age.
RESULTS
Higher proinflammatory (interleukin [IL] 1, IL-6, tumor necrosis factor) and regulatory (IL-10) cytokine concentrations during the second year of life were associated with reduced incidence of clinical malaria up to 4 years of age, adjusting by chemoprophylaxis and prior malaria exposure. Significantly lower concentrations of antigen-specific T-helper 1 (IL-2, IL-12, interferon-γ) and T-helper 2 (IL-4, IL-5) cytokines by 2 years of age were measured in children undergoing chemoprophylaxis compared to children receiving placebo (P < .03).
CONCLUSIONS
Selective chemoprophylaxis altering early natural exposure to malaria blood stage antigens during infancy had a significant effect on T-helper lymphocyte cytokine production >1 year later. Importantly, a balanced proinflammatory and anti-inflammatory cytokine signature, probably by innate cells, around age 2 years was associated with protective clinical immunity during childhood.
CLINICAL TRIALS REGISTRATION
NCT00231452.",2019,"Significantly lower concentrations of antigen-specific TH1 (IL-2, IL-12, IFN-) and TH2 (IL-4, IL-5) cytokines by 2 years of age were measured in children under chemoprophylaxis compared to children receiving placebo (p<0.03).
","['malaria exposure during infancy, peripheral blood mononuclear cells collected at ages 2.5, 5.5, 10.5, 15 and 24 months were stimulated ex vivo with parasite schizont and erythrocyte lysates', 'young African children']","['sulfadoxine-pyrimethamine plus artesunate', 'placebo']","['concentrations of antigen-specific TH1 (IL-2, IL-12, IFN-\uf067) and TH2 (IL-4, IL-5) cytokines', 'TH lymphocyte cytokine production', 'pro-inflammatory (IL-1, IL-6, TNF) and regulatory (IL-10) cytokine concentrations']","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0231330', 'cui_str': 'Infancy - period'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0521066', 'cui_str': 'parasites'}, {'cui': 'C0562656', 'cui_str': 'Schizonts'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0700599', 'cui_str': 'Pyrimethamine / Sulfadoxine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0033268'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.290244,"Significantly lower concentrations of antigen-specific TH1 (IL-2, IL-12, IFN-) and TH2 (IL-4, IL-5) cytokines by 2 years of age were measured in children under chemoprophylaxis compared to children receiving placebo (p<0.03).
","[{'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Dobaño', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Augusto J', 'Initials': 'AJ', 'LastName': 'Nhabomba', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça, Maputo, Mozambique.'}, {'ForeName': 'Maria N', 'Initials': 'MN', 'LastName': 'Manaca', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça, Maputo, Mozambique.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Berthoud', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Aguilar', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Llorenç', 'Initials': 'L', 'LastName': 'Quintó', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Arnoldo', 'Initials': 'A', 'LastName': 'Barbosa', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Mauricio H', 'Initials': 'MH', 'LastName': 'Rodríguez', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Alfons', 'Initials': 'A', 'LastName': 'Jiménez', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Penny L', 'Initials': 'PL', 'LastName': 'Groves', 'Affiliation': 'Institució Catalana de Recerca i Estudis Avançats, Barcelona, Spain.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Santano', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Quique', 'Initials': 'Q', 'LastName': 'Bassat', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Aponte', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Guinovart', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Denise L', 'Initials': 'DL', 'LastName': 'Doolan', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Alonso', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy934']
717,17396084,Patient information for liver biopsy: impact of a video movie.,"AIMS
The information given to patients before a medical procedure is usually delivered verbally and in the form of a written document. Viewing a video movie about the procedure might be helpful in improving the quality of patient information and thus contributed to reduce patient anxiety. The aim of this prospective study on the methods used to deliver information to patients scheduled for liver biopsy was to determine, in comparison with standard information delivery, the impact on anxiety and understanding of additional information provided by a video movie.
METHODS
Patients included in this study were scheduled for liver biopsy. Three days before the procedure, a physician informed the patients about liver biopsy and gave them a written information document. After this standard information delivery, the patients were randomly assigned to two groups, to view or not a video movie illustrating liver biopsy and recalling the information provided in the information document. Anxiety was measured after the information visit and just before the biopsy procedure using Spielberger's self-administered STAI-Y questionnaire. Patient understanding of and satisfaction with the information received were evaluated respectively before and after the procedure.
RESULTS
Among the 67 patients retained for analysis, 33 viewed the information video and 34 did not. The level of anxiety measured at the information visit and before liver biopsy was similar in the two groups (38.8 and 37.4 with video versus 38.9 and 40.1 without video). The patients had an excellent understanding of the information received (12.3/14 with video; 12.7/14 without video) and were well satisfied with the information received.
CONCLUSION
The patients understood and were well satisfied with the information received about liver biopsy. Complementary information in the form of a video movie had no effect on patient anxiety.",2007,The level of anxiety measured at the information visit and before liver biopsy was similar in the two groups (38.8 and 37.4 with video versus 38.9 and 40.1 without video).,"['Patients included in this study were scheduled for liver biopsy', '67 patients retained for analysis, 33 viewed the information video and 34 did not']","['video movie', 'video movie illustrating liver biopsy and recalling the information provided in the information document']","['Anxiety', 'level of anxiety', 'patient anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver (procedure)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver (procedure)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",67.0,0.0364212,The level of anxiety measured at the information visit and before liver biopsy was similar in the two groups (38.8 and 37.4 with video versus 38.9 and 40.1 without video).,"[{'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Obled', 'Affiliation': ""Service d'Hépato-Gastroentérologie, CHU Nîmes, Cedex. stephane.obled@chu-nimes.fr""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Melki', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Coelho', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Coudeyre', 'Affiliation': ''}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Arpurt', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Pouderoux', 'Affiliation': ''}]",Gastroenterologie clinique et biologique,[]
718,16505756,Longitudinal quality of life study in patients with metastatic gastric cancer. Analysis modalities and clinical applicability of QoL in randomized phase II trial in a digestive oncology.,"OBJECTIVES
The aim of this study was to compare the longitudinal quality of life (QoL) between LV5FU2-irinotecan and LV5FU2 alone or LV5FU2-cisplatin in a randomized Phase II trial in patients with metastatic gastric adenocarcinoma.
METHODS
Among 134 eligible patients, QLQ-C30 scores were collected and described at each 2 monthly follow-up visit during 6 months. The frequencies of QLQ-C30 score improvement were calculated and mixed models for repeated measurements were applied with or without extreme poorest imputation for missing scores. The ""survival"" until definitive global health score (GHS) deterioration was estimated.
RESULTS
At the 3rd follow-up, patients with a stable or improved global health ranged from 11% in the LV5FU2-cisplatin arm to 18% in the LV5FU2-irinotecan arm. The irinotecan-based-therapy presented 14 to 15 scores with a better QoL. The time until definitive GHS deterioration was globally similar between treatment arms.
CONCLUSION
This study highlights a better impact of LV5FU2-irinotecan and the interest of QoL assessment in phase II trials to complement the risk-benefit judgement.",2005,"The irinotecan-based-therapy presented 14 to 15 scores with a better QoL. The time until definitive GHS deterioration was globally similar between treatment arms.
","['patients with metastatic gastric adenocarcinoma', '134 eligible patients', 'patients with metastatic gastric cancer']","['LV5FU2-irinotecan', 'LV5FU2-irinotecan and LV5FU2 alone or LV5FU2-cisplatin', 'LV5FU2-cisplatin']","['frequencies of QLQ-C30 score improvement', 'survival"" until definitive global health score (GHS) deterioration', 'time until definitive GHS deterioration', 'QLQ-C30 scores', 'global health', 'longitudinal quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3160888', 'cui_str': 'Metastatic gastric adenocarcinoma'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0278498', 'cui_str': 'Metastatic gastric cancer'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0034380'}]",134.0,0.0276214,"The irinotecan-based-therapy presented 14 to 15 scores with a better QoL. The time until definitive GHS deterioration was globally similar between treatment arms.
","[{'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Bonnetain', 'Affiliation': ""INSERM EMI 106 and Federation Francophone de Cancerologie Digestive, Faculty of Medicine, 7 Bd Jeanne d'Arc, BP 879000, 21079 Dijon cedex. FBonnetain@dijon.fnclcc.fr""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bouché', 'Affiliation': ''}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Conroy', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Arveux', 'Affiliation': ''}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Raoul', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Giovannini', 'Affiliation': ''}, {'ForeName': 'Pierre Luc', 'Initials': 'PL', 'LastName': 'Etienne', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Mitry', 'Affiliation': ''}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Seitz', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rougier', 'Affiliation': ''}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Girault', 'Affiliation': ''}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bedenne', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterologie clinique et biologique,[]
719,16505759,Comparative pilot study of repeated large volume paracentesis vs the combination on clonidine-spironolactone in the treatment of cirrhosis-associated refractory ascites.,"OBJECTIVES
To study the usefulness of the combination of clonidine--spironolactone in refractory ascites.
METHODS
Twenty cirrhotic patients with refractory ascites were randomly assigned to receive repeated large volume paracentesis plus intravenous albumin (group 1), or a combination of clonidine (0.075 mg twice daily) and spironolactone (200 to 400 mg daily) (group 2).
RESULTS
During the first hospitalisation,, the mean weight loss in group 1 was higher than in group 2 (12.4 +/- 3.2 versus 4.3 +/- 1.1 kg, P < or = 0.01). Mean stay in hospital was shorter in group 2 (20 +/- 1.5 versus 10 +/- 2.8 days; P < or = 0.01). Paracentesis did not induce changes in neuro-hormonal measurements. Oppositely, clonidine induced a decreased sympathetic activity, an increased glomerular filtration rate and a delayed reduction of the renin-aldosterone levels. During the follow-up in group 1, the number of rehospitalisations for ascites was higher than in group 2 (37 versus 3; P < or = 0.01), and the mean time to the first readmission was shorter (10 +/- 2.7 versus 23.7 +/- 5.6 days; P < or = 0.01). The total duration spent in hospital were similar in both groups.
CONCLUSION
Paracentesis is more effective for short-term treatment of ascites but clonidine-spironolactone association might provide better long-term control.",2005,"During the follow-up in group 1, the number of rehospitalisations for ascites was higher than in group 2 (37 versus 3; P < or = 0.01), and the mean time to the first readmission was shorter (10 +/-","['Twenty cirrhotic patients with refractory ascites', 'cirrhosis-associated refractory ascites']","['clonidine--spironolactone', 'clonidine', 'clonidine-spironolactone', 'large volume paracentesis plus intravenous albumin', 'spironolactone']","['total duration spent in hospital', 'neuro-hormonal measurements', 'number of rehospitalisations for ascites', 'mean time to the first readmission', 'mean weight loss', 'Mean stay in hospital', 'sympathetic activity', 'renin-aldosterone levels', 'glomerular filtration rate']","[{'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3532188', 'cui_str': 'Refractory ascites (disorder)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]",20.0,0.0206323,"During the follow-up in group 1, the number of rehospitalisations for ascites was higher than in group 2 (37 versus 3; P < or = 0.01), and the mean time to the first readmission was shorter (10 +/-","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lenaerts', 'Affiliation': 'University Department of Hepato-Gastroenterology, CHU de Charleroi, Charleroi, Belgium. anne.lenaerts@chu-charleroi.be'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Codden', 'Affiliation': ''}, {'ForeName': 'Jean-Pol', 'Initials': 'JP', 'LastName': 'Henry', 'Affiliation': ''}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Legros', 'Affiliation': ''}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'Ligny', 'Affiliation': ''}]",Gastroenterologie clinique et biologique,[]
720,30321084,Neuromuscular electrical stimulation combined with exercise decreases duration of mechanical ventilation in ICU patients: A randomized controlled trial.,"BACKGROUND
Early mobilization can be employed to minimize the duration of intensive care. However, a protocol combining neuromuscular electrical stimulation (NMES) with early mobilization has not yet been tested in ICU patients. Our aim was to assess the efficacy of NMES, exercise (EX), and combined therapy (NMES + EX) on duration of mechanical ventilation (MV) in critically ill patients.
METHODS
The participants in this randomized double-blind trial were prospectively recruited within 24 hours following admission to the intensive care unit of a tertiary hospital. Eligible patients had 18 years of age or older; MV for less than 72 hours; and no known neuromuscular disease. Computer-generated permuted block randomization was used to assign patients to NMES, EX, NMES + EX, or standard care (control group). The main endpoint was duration of MV. Clinical characteristics were also evaluated and intention to treat analysis was employed.
RESULTS
One hundred forty-four patients were assessed for eligibility to participate in the trial, 51 of whom were enrolled and randomly allocated into four groups: 11 patients in the NMES group, 13 in the EX group, 12 in the NMES + EX group, and 15 in the control group (CG). Duration of MV (days) was significantly shorter in the combined therapy (5.7 ± 1.1) and NMEN (9.0 ± 7.0) groups in comparison to CG (14.8 ± 5.4).
CONCLUSIONS
NMES + EX consisting of NMES and active EXs was well tolerated and resulted in shorter duration of MV in comparison to standard care or isolated therapy (NMES or EX alone).",2020,"Duration of MV (days) was significantly shorter in the combined therapy (5.7 ± 1.1) and NMEN (9.0 ± 7.0) groups in comparison to CG (14.8 ± 5.4).
","['Eligible patients had 18\xa0years of age or older', 'One hundred forty-four patients were assessed for eligibility to participate in the trial, 51 of whom were enrolled and randomly allocated into four groups: 11 patients in the NMES group, 13 in the EX group, 12 in the', 'critically ill patients', 'ICU patients']","['protocol combining neuromuscular electrical stimulation (NMES', 'Neuromuscular electrical stimulation combined with exercise', 'NMES\xa0+\xa0EX', 'NMES, exercise (EX), and combined therapy (NMES\xa0+\xa0EX', 'NMES, EX, NMES\xa0+\xa0EX, or standard care (control group']","['Duration of MV (days', 'duration of mechanical ventilation (MV', 'mechanical ventilation', 'shorter duration of MV', 'duration of MV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033972', 'cui_str': 'Psychotherapy, Multiple'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}]",144.0,0.212725,"Duration of MV (days) was significantly shorter in the combined therapy (5.7 ± 1.1) and NMEN (9.0 ± 7.0) groups in comparison to CG (14.8 ± 5.4).
","[{'ForeName': 'Francisco Valdez', 'Initials': 'FV', 'LastName': 'Dos Santos', 'Affiliation': 'Physical Therapy Department, University of Brasilia , Brasilia, Brazil.'}, {'ForeName': 'Gerson', 'Initials': 'G', 'LastName': 'Cipriano', 'Affiliation': 'Physical Therapy Department, University of Brasilia , Brasilia, Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Vieira', 'Affiliation': 'Physical Therapy Department, University of Brasilia , Brasilia, Brazil.'}, {'ForeName': 'Adriana M', 'Initials': 'AM', 'LastName': 'Güntzel Chiappa', 'Affiliation': 'Intensive Care Unit, Hospital de Clinicas de Porto Alegre , Porto Alegre, Brazil.'}, {'ForeName': 'Graziella B F', 'Initials': 'GBF', 'LastName': 'Cipriano', 'Affiliation': 'Physical Therapy Department, University of Brasilia , Brasilia, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Vieira', 'Affiliation': 'Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Julio G', 'Initials': 'JG', 'LastName': 'Zago', 'Affiliation': 'Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Mariah', 'Initials': 'M', 'LastName': 'Castilhos', 'Affiliation': 'Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Marianne L', 'Initials': 'ML', 'LastName': 'da Silva', 'Affiliation': 'Physical Therapy Department, University of Brasilia , Brasilia, Brazil.'}, {'ForeName': 'Gaspar R', 'Initials': 'GR', 'LastName': 'Chiappa', 'Affiliation': 'Physical Therapy Department, University of Brasilia , Brasilia, Brazil.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1490363']
721,16633299,Oxaliplatin combined with 5-FU in second line treatment of advanced pancreatic adenocarcinoma. Results of a phase II trial.,"BACKGROUND
The efficacy and benefit of second-line chemotherapy in advanced pancreatic adenocarcinoma has never been demonstrated although it is regularly used.
PATIENTS AND METHODS
A randomized phase II study evaluating oxaliplatin alone (OXA), infusional 5-fluorouracil alone (5-FU) and an oxaliplatin/infusional 5-FU combination (OXFU) in untreated advanced pancreatic adenocarcinoma has been conducted. In this trial, a second-line treatment with the OXFU regimen (OXA 130 mg/m2 2-h intravenous (i.v.) infusion combined with 5-FU (1000 mg/m2/day, continuous i.v., days 1-4), every 3 weeks) was offered to patients progressing after single agent treatment.
RESULTS
Eighteen out of 32 patients (12 males, median age 57 years) treated in the single agent arms received the OXFU combination in second-line treatment. WHO performance status was at least 2 in 61% of the patients. There was no objective response and 3 patients (17%) had a disease stabilisation. Median time to progression from the start of second-line treatment was 0.9 months. Median overall survival was 4.9 months from the start of front-line therapy and 1.3 months from the start of second-line therapy.
CONCLUSION
The results of this trial bring arguments to support a modest value of second-line chemotherapy for advanced pancreatic adenocarcinoma.",2006,There was no objective response and 3 patients (17%) had a disease stabilisation.,"['advanced pancreatic adenocarcinoma', 'untreated advanced pancreatic adenocarcinoma', 'Eighteen out of 32 patients (12 males, median age 57 years']","['second-line chemotherapy', 'OXFU regimen (OXA 130 mg/m2 2-h intravenous (i.v.) infusion combined with 5-FU', 'OXFU combination in second-line treatment', 'oxaliplatin alone (OXA), infusional 5-fluorouracil alone (5-FU) and an oxaliplatin/infusional 5-FU combination (OXFU', 'Oxaliplatin combined with 5-FU']","['disease stabilisation', 'WHO performance status', 'Median time to progression', 'Median overall survival']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",32.0,0.0326028,There was no objective response and 3 patients (17%) had a disease stabilisation.,"[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Mitry', 'Affiliation': 'CHU Ambroise Paré, Boulogne. emmanuel.mitry@apr.aphp.fr'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ducreux', 'Affiliation': ''}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Ould-Kaci', 'Affiliation': ''}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Boige', 'Affiliation': ''}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Seitz', 'Affiliation': ''}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Bugat', 'Affiliation': ''}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Breau', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bouché', 'Affiliation': ''}, {'ForeName': 'Pierre-Luc', 'Initials': 'PL', 'LastName': 'Etienne', 'Affiliation': ''}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Tigaud', 'Affiliation': ''}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Morvan', 'Affiliation': ''}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Cvitkovic', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rougier', 'Affiliation': ''}]",Gastroenterologie clinique et biologique,[]
722,30353262,Default mode network connectivity change corresponds to ketamine's delayed glutamatergic effects.,"Ketamine exerts rapid antidepressant effects peaking 24 h after a single infusion, which have been suggested to be reflected by both reduced functional connectivity (FC) within default mode network (DMN) and altered glutamatergic levels in the perigenual anterior cingulate cortex (pgACC) at 24 h. Understanding the interrelation and time point specificity of ketamine-induced changes of brain circuitry and metabolism is thus key to future therapeutic developments. We investigated the correlation of late glutamatergic changes with FC changes seeded from the posterior cingulate cortex (PCC) and tested the prediction of the latter by acute fractional amplitude of low-frequency fluctuations (fALFF). In a double-blind, randomized, placebo-controlled study of 61 healthy subjects, we compared effects of subanesthetic ketamine infusion (0.5 mg/kg over 40 min) on resting-state fMRI and MR-Spectroscopy at 7 T 1 h and 24 h post-infusion. FC decrease between PCC and dorsomedial prefrontal cortex (dmPFC) was found at 24 h post-infusion (but not 1 h) and this FC decrease correlated with glutamatergic changes at 24 h in pgACC. Acute increase in fALFF was found in ventral PCC at 1 h which was not observed at 24 h and inversely correlated with the reduced dPCC FC towards the dmPFC at 24 h. The correlation of metabolic and functional markers of delayed ketamine effects and their temporal specificity suggest a potential mechanistic relationship between glutamatergic modulation and reconfiguration of brain regions belonging to the DMN.",2020,Acute increase in fALFF was found in ventral PCC at 1 h which was not observed at 24 h and inversely correlated with the reduced dPCC FC towards the dmPFC at 24 h.,['61 healthy subjects'],"['Ketamine', 'ketamine', 'placebo', 'subanesthetic ketamine infusion']","['dPCC FC', 'glutamatergic changes', 'FC decrease between PCC and dorsomedial prefrontal cortex (dmPFC', 'Acute increase in fALFF']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",61.0,0.0851681,Acute increase in fALFF was found in ventral PCC at 1 h which was not observed at 24 h and inversely correlated with the reduced dPCC FC towards the dmPFC at 24 h.,"[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Clinical Affective Neuroimaging Laboratory, Leibniz Institute for Neurobiology, Magdeburg, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Woelfer', 'Affiliation': 'Clinical Affective Neuroimaging Laboratory, Leibniz Institute for Neurobiology, Magdeburg, Germany.'}, {'ForeName': 'Lejla', 'Initials': 'L', 'LastName': 'Colic', 'Affiliation': 'Clinical Affective Neuroimaging Laboratory, Leibniz Institute for Neurobiology, Magdeburg, Germany.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Safron', 'Affiliation': 'Department of Psychology, Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Catie', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'Department of Electrical Engineering and Computer Science, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Hans-Jochen', 'Initials': 'HJ', 'LastName': 'Heinze', 'Affiliation': 'Department of Neurology, Otto-von-Guericke-University, Magdeburg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Speck', 'Affiliation': 'Department Behavioral Neurology, Leibniz Institute for Neurobiology, Magdeburg, Germany.'}, {'ForeName': 'Helen S', 'Initials': 'HS', 'LastName': 'Mayberg', 'Affiliation': 'Department of Neurology and Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Bharat B', 'Initials': 'BB', 'LastName': 'Biswal', 'Affiliation': 'New Jersey Institute of Technology, Newark, NJ, USA.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Salvadore', 'Affiliation': 'Janssen Research and Development, Titusville, NJ, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fejtova', 'Affiliation': 'Center for Behavioral Brain Sciences (CBBS), Magdeburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'Clinical Affective Neuroimaging Laboratory, Leibniz Institute for Neurobiology, Magdeburg, Germany. martin.walter@uni-tuebingen.de.'}]",European archives of psychiatry and clinical neuroscience,['10.1007/s00406-018-0942-y']
723,18166880,Colorectal cancer screening program: cost effectiveness of systematic recall letters.,"OBJECTIVES
The French colorectal cancer screening program has planned a stepwise strategy for delivery of a fecal occult blood test kit (Hemocult II) with an initial medical phase followed by systematic mailing of the test. Our aim was to ascertain the cost effectiveness of another recall method.
METHODS
In the Bouches-du-Rhône administrative area, we conducted a cost effectiveness study comparing two second line delivery methods: mailing the test kit systematically to all non-responders to the initial medical phase (conventional strategy) and mailing the test kit to non-responders to the initial medical phase who requested a kit after receiving a recall letter (experimental strategy). After randomization, two groups were constituted among a sample of 10 930 persons.
RESULTS
The participation rate was significantly higher in the conventional strategy group than with the experimental strategy group (14.7% vs 8.3%; P<10(-5)). The mean cost of the conventional strategy test was 33.59 euros compared to only 18.50 euros with the experimental strategy (kit mailed only to persons who requested it).
CONCLUSION
These findings suggest that mailing a recall letter with a test order coupon can lead to substantial economy with a lost of participation of 6.4% at the test mailing phase. Better allocation of the spared cost (communication, information) might lead to increased participation, a hypothesis which should be tested further.",2007,"The mean cost of the conventional strategy test was 33.59 euros compared to only 18.50 euros with the experimental strategy (kit mailed only to persons who requested it).
",['10 930 persons'],"['systematic recall letters', 'Colorectal cancer screening program', 'initial medical phase (conventional strategy) and mailing the test kit to non-responders to the initial medical phase who requested a kit after receiving a recall letter (experimental strategy']","['mean cost of the conventional strategy test', 'participation rate']","[{'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1690540', 'cui_str': 'Kit'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",10930.0,0.0211889,"The mean cost of the conventional strategy test was 33.59 euros compared to only 18.50 euros with the experimental strategy (kit mailed only to persons who requested it).
","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Tifratene', 'Affiliation': 'Centre de coordination du dépistage des cancers dans les Bouches-du-Rhône (ARCADES), Centre hospitalier universitaire La Timone, Marseillle Cedex 5. arcades@cesdoria.com'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Eisinger', 'Affiliation': ''}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rinaldi', 'Affiliation': ''}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Didelot', 'Affiliation': ''}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Seitz', 'Affiliation': ''}]",Gastroenterologie clinique et biologique,[]
724,17541337,Routine practice HCV infection screening with saliva samples: multicentric study in an intravenous drug user population.,"OBJECTIVE
The purpose of this randomized multicentric study was to evaluate the diagnostic contribution of screening for HCV infection on saliva samples in day-to-day practice in the intravenous drug-user (IVDU) population.
METHODS
Between January and May 2004, 274 presumably HCV-negative IVDU were screened for HCV infection in 15 centers in France (median age 29 years). After centralized randomization, screening tests were performed on blood samples (arm A) or saliva samples (arm B). Screening tests were performed in 78 subjects (28%) had never been screened before and in 196 subjects (72%) who had had a negative HCV screening test on average 12 months prior to the beginning of the study. In the event of a positive saliva test for anti-HCV Ab, a serum test for anti-HCV Ab was performed. In the event of a positive serum test for anti-HCV Ab, PCR was performed on serum to measure HCV-RNA.
RESULTS
Fourteen individuals were positive for HCV RNA (7 in each arm). Six of these cases had not been detected before. In eight cases, the median time between the last negative screening test and study inclusion was 11 months (range 6-94 months).
CONCLUSIONS
Viremia tests were positive in 5% percent of the target population, although one-third of the individuals in arm A (blood samples) were not tested. The saliva test may be a useful alternative in the event of refusal of a blood test or when poor venous conditions compromise venous puncture. A confirmatory blood test still remains difficult to obtain in nearly half of patients.",2007,Screening tests were performed in 78 subjects (28%) had never been screened before and in 196 subjects (72%) who had had a negative HCV screening test on average 12 months prior to the beginning of the study.,"['78 subjects (28%) had never been screened before and in 196 subjects (72%) who had had a negative HCV screening test on average 12 months prior to the beginning of the study', 'Between January and May 2004, 274 presumably HCV-negative IVDU were screened for HCV infection in 15 centers in France (median age 29 years']",[],"['positive for HCV RNA', 'median time']","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242566', 'cui_str': 'Intravenous drug user (finding)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",14.0,0.027423,Screening tests were performed in 78 subjects (28%) had never been screened before and in 196 subjects (72%) who had had a negative HCV screening test on average 12 months prior to the beginning of the study.,"[{'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Lucidarme', 'Affiliation': ""Groupe Hospitalier de l'Institut Catholique de Lille, Hôpital Saint-Philibert, Lomme. lucidarme.damien@ghicl.net""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Decoster', 'Affiliation': ''}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Fremaux', 'Affiliation': ''}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Harbonnier', 'Affiliation': ''}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Jacob', 'Affiliation': ''}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Vosgien', 'Affiliation': ''}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Josse', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Villeger', 'Affiliation': ''}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Henrio', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Prouvost-Keller', 'Affiliation': ''}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Saccardy', 'Affiliation': ''}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Lemaire', 'Affiliation': ''}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Vazeille', 'Affiliation': ''}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Duchene', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Thuillier', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Colbeaux', 'Affiliation': ''}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Lefebvre', 'Affiliation': ''}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Forzy', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Filoche', 'Affiliation': ''}]",Gastroenterologie clinique et biologique,[]
725,16733374,"High dose daily interferon-alpha induction and secondary adjunction of ribavirin in treatment-naive patients with chronic hepatitis C. A multicentric, randomised, controlled trial.","OBJECTIVES
To evaluate in naive patients with chronic hepatitis C 1- the efficacy and safety of one month interferon alpha (IFN-alpha) induction regimen; 2- the potential virological benefit of a secondary adjunction of ribavirin among HCV RNA negative patients after 20 weeks of IFN therapy, with or without an initial 4-week IFN induction.
MATERIAL AND METHODS
151 naive HCV-RNA positive patients presenting with biopsy- proven chronic hepatitis C and elevated ALT were randomised in a 2: 1 ratio in two arms: IFN-alpha 3 MU thrice a week (tiw) for 24 weeks (non-induced patients); IFN-alpha 6 MU daily for two weeks, then 3 MU daily for two weeks then 3 MU tiw for 20 weeks (induced patients). At week 24, HCV-RNA negative patients were randomised to receive in addition or not ribavirin 1-1.2 g daily for 24 additional weeks. Induction efficacy was assessed on the early viral response (EVR) defined as undetectable HCV RNA at week 4 then week 20. Ribavirin efficacy was assessed on the proportion of maintained complete response until the end of follow-up, 24 weeks after discontinuation of treatment. Data were analysed on an intent-to-treat basis.
RESULTS
Efficacy of IFN-alpha induction: 104 patients were randomised to the non-induction group, 47 to the induction group. Gender, age, genotype distribution and HCV viral load at baseline did not differ significantly between the two groups. There was one treatment discontinuation because of adverse events in induced patients versus four in non-induced patients (P > 0.05). The 4 week EVR was significantly greater in induced patients in patients with HCV genotype 1, 4 or 5 (47% vs 12%, P=0.0002) only. There was no impact of induction in patients with HCV genotype 2 or 3. Efficacy of ribavirin: at week 24, 28 and 26 HCV-RNA negative patients were randomised to addition of ribavirin or not, respectively. Patients randomised to secondary additive ribavirin were more often HCV-RNA negative at the end of follow-up than patients treated with IFN-alpha alone: 18/28 (64%) vs 10/26 (39%); P=0.06. Among patients randomised to bitherapy, the relapse rate was significantly lower in patients with genotype 2 or 3 (0/12 vs 6/13, P=0.01) and not in those with genotype 1, 4 or 5 (5/11 vs 3/6, P=0.99).
CONCLUSION
A 4 week IFN-alpha induction significantly increases the EVR rate in patients with HCV genotype 1, 4 or 5. Late secondary adjunction of ribavirin to IFN-alpha for 6 months in HCV-RNA negative patients after 6 months of IFN-alpha significantly decreases the relapse rate in patients with HCV genotype 2 or 3, but not in patients with genotypes 1, 4 or 5.",2006,"A 4 week IFN-alpha induction significantly increases the EVR rate in patients with HCV genotype 1, 4 or 5.","['treatment-naive patients with chronic hepatitis C', '104 patients were randomised to the non-induction group, 47 to the induction group', '151 naive HCV-RNA positive patients presenting with biopsy- proven chronic hepatitis C and elevated ALT', 'naive patients with chronic hepatitis C', 'week 24, 28 and 26 HCV-RNA negative patients', 'patients with HCV genotype 2 or 3']","['IFN-alpha induction', 'interferon alpha (IFN-alpha) induction regimen', 'IFN-alpha alone', 'ribavirin', 'secondary additive ribavirin', 'interferon-alpha induction']","['relapse rate', 'Ribavirin efficacy', 'EVR rate', 'HCV-RNA negative', 'early viral response (EVR', 'Induction efficacy', 'adverse events', 'HCV viral load']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524910', 'cui_str': 'Hepatitis C, Chronic'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0442796', 'cui_str': 'Additive (qualifier value)'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1868902', 'cui_str': 'HCV viral load'}]",104.0,0.0566688,"A 4 week IFN-alpha induction significantly increases the EVR rate in patients with HCV genotype 1, 4 or 5.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Wartelle-Bladou', 'Affiliation': ""Centre Hospitalier du Pays d'Aix, Service d'Hépato-Gastroentérologie, Avenue des Tamaris, 13616 Aix en Provence Cedex. cwartelle@ch-aix.fr""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Arpurt', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Renou', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Pariente', 'Affiliation': ''}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Pillon', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Nalet', 'Affiliation': ''}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Picon', 'Affiliation': ''}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Glibert', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chousterman', 'Affiliation': ''}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Grasset', 'Affiliation': ''}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Morin', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bernard', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fischer', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ramdani', 'Affiliation': ''}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Lagier', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rotily', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterologie clinique et biologique,[]
726,16142002,Quality of life scale and impact of a topical treatment on symptoms of gastro-esophageal reflux without severe esophagitis.,"OBJECTIVE
Restoring a normal quality of life (QOL) should be the goal of treatments of gastro-esophageal reflux (GER) without severe esophagitis. In this analysis, carried out within the frame of a clinical study comparing a topical anti-inflammatory gel to a placebo, we assessed the relevance of the MOS SF-36 questionnaire in patients suffering from GER without severe esophagitis, and compared the scores of the studied patients to those of a representative sample of the French general population.
PATIENTS AND METHODS
The patients had to suffer from GER symptoms for at least 2 months, with no or mild (< or =grade 1) esophagitis endoscopy. They were randomized to be given a 4 week treatment either with a topical gel containing gaïazulene and dimeticone or a placebo gel. Patients were asked to complete a symptom diary during the study, which allowed the calculation of mean symptom scores. The MOS SF-36 questionnaire was administered at baseline (d0) and after 4 weeks of treatment (d28).
RESULTS
Two hundred and thirty three patients were enrolled in the study. At baseline, QOL scores were impaired in both groups. After 4 weeks of treatment: the treated patients displayed better improvement in all MOS SF-36 domains compared with the placebo group. The QOL profile in the treated group reached the level of the French reference population, while it remained impaired in the placebo group.
CONCLUSION
This analysis evidenced the relevancy of the MOS SF-36 questionnaire to assess the impact of GER without severe esophagitis on QOL. Moreover, it demonstrated the capacity of the studied topical treatment to restore a normal QOL to the patients.",2005,After 4 weeks of treatment: the treated patients displayed better improvement in all MOS SF-36 domains compared with the placebo group.,"['gastro-esophageal reflux (GER) without severe esophagitis', 'Two hundred and thirty three patients were enrolled in the study', 'patients suffering from GER without severe esophagitis, and compared the scores of the studied patients to those of a representative sample of the French general population']","['placebo', 'topical gel containing gaïazulene and dimeticone or a placebo gel']","['symptoms of gastro-esophageal reflux without severe esophagitis', 'Quality of life scale', 'MOS SF-36 domains', 'QOL profile', 'normal quality of life (QOL', 'QOL scores', 'MOS SF-36 questionnaire']","[{'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0230779', 'cui_str': 'Endoplasmic Reticulum, Granular'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1160728', 'cui_str': 'Topical Gel'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1113707', 'cui_str': 'dimeticone'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",233.0,0.10809,After 4 weeks of treatment: the treated patients displayed better improvement in all MOS SF-36 domains compared with the placebo group.,"[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Leplège', 'Affiliation': 'Université Picardie Jules Verne, UFR Philosophie, Sciences Humaines et Sociales, Chemin du Thil, 80025 Amiens, France. alain.leplege@u-picardie.fr'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Mackenzie-Schliacowsky', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Eacute Cosse', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ruszniewski', 'Affiliation': ''}]",Gastroenterologie clinique et biologique,[]
727,15523219,Predictive factors of alcohol relapse after orthotopic liver transplantation for alcoholic liver disease.,"OBJECTIVES
The objective of this prospective study was to determine whether sociological and/or alcohol-related behavioral factors could be predictive of relapse after orthotopic liver transplantation for alcoholic liver disease.
METHODS
Fifty-five liver-transplanted patients out of a series of 120 alcoholic cirrhotic patients were enrolled in a randomized prospective study. This study was initially designed to compare the 2 year survival in intent-to-transplant patients versus in-intent-to-use conventional treatment patients. For all patients, an identical questionnaire was completed at inclusion, and every 3 months for 5 years to collect data on alcohol-related behavior factors.
RESULTS
Fifty-one patients fulfilled the criteria for the study. The mean follow-up was 35.7 months (range: 1-86). Rate of alcohol relapse was 11% at one year and 30% at 2 years. Alcohol intake above 140 g a week was declared by 11% and 22% of patients at one and 2 years, respectively. The only variable leading to a significantly lower rate of relapse was abstinence for 6 months or more before liver transplantation (23% vs 79%, P=0.0003). This variable was also significant for patients whose alcohol intake was greater than 140 g per week (P=0.003) (adjusted relative risk=5.5; 95%CI=1.3-24.5; P=0.02). Multivariate analysis (Cox model) showed that abstinence for 6 months or more before liver transplantation was the unique predictive variable.
CONCLUSION
In this prospective study of 51 patients transplanted for alcoholic liver disease, abstinence before liver transplantation was the only predictive factor of alcohol relapse after liver transplantation.",2004,"Alcohol intake above 140 g a week was declared by 11% and 22% of patients at one and 2 years, respectively.","['Fifty-five liver-transplanted patients out of a series of 120 alcoholic cirrhotic patients', 'Fifty-one patients fulfilled the criteria for the study', 'alcoholic liver disease', '51 patients transplanted for alcoholic liver disease, abstinence before liver transplantation was the only predictive factor of alcohol relapse after liver transplantation']",['orthotopic liver transplantation'],"['alcohol intake', 'Alcohol intake', 'Rate of alcohol relapse', 'rate of relapse']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0687725', 'cui_str': 'Alcoholics'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0023896', 'cui_str': 'Alcoholic Liver Diseases'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0574893', 'cui_str': 'Orthotopic (qualifier value)'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",51.0,0.0240137,"Alcohol intake above 140 g a week was declared by 11% and 22% of patients at one and 2 years, respectively.","[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Miguet', 'Affiliation': 'Hôpital Jean Minjoz, Besançon. scoffre@club-internet.fr'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Monnet', 'Affiliation': ''}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Vanlemmens', 'Affiliation': ''}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Gache', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Messner', 'Affiliation': ''}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Hruskovsky', 'Affiliation': ''}, {'ForeName': 'Jean Marc', 'Initials': 'JM', 'LastName': 'Perarnau', 'Affiliation': ''}, {'ForeName': 'Georges-Philippe', 'Initials': 'GP', 'LastName': 'Pageaux', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Duvoux', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Minello', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Hillon', 'Affiliation': ''}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Bresson-Hadni', 'Affiliation': ''}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Mantion', 'Affiliation': ''}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Miguet', 'Affiliation': ''}]",Gastroenterologie clinique et biologique,[]
728,31524941,Association Between Low-Dose Rivaroxaban With or Without Aspirin and Ischemic Stroke Subtypes: A Secondary Analysis of the COMPASS Trial.,"Importance
The COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) randomized clinical trial was stopped early owing to the efficacy of low-dose rivaroxaban plus aspirin in preventing major cardiovascular events. The main reason for early trial termination was the effect of combination therapy on reducing ischemic strokes.
Objective
To analyze the association between low-dose rivaroxaban with or without aspirin and different ischemic stroke subtypes.
Design, Setting, and Participants
This is a secondary analysis of a multicenter, double-blind, randomized, placebo-controlled study that was performed in 33 countries from March 12, 2013, to May 10, 2016. Patients with stable atherosclerotic vascular disease were eligible, and a total of 27 395 participants were randomized and followed up to February 6, 2017. All first ischemic strokes and uncertain strokes that occurred by this date were adjudicated using TOAST (Trial of Org 10172 in Acute Stroke Treatment) criteria. The analysis of ischemic stroke subtypes was evaluated using an intention-to-treat principle. Statistical analysis was performed from March 12, 2013, to February 6, 2017.
Interventions
Participants received rivaroxaban (2.5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban (5 mg twice a day), or aspirin (100 mg once a day).
Main Outcomes and Measures
Risk of ischemic stroke subtypes during follow-up.
Results
A total of 291 patients (66 women; mean [SD] age, 69.4 [8.5] years; 43 [14.8%] had a previous nonlacunar stroke) experienced an ischemic stroke. During the study, 49 patients (16.8%) received a diagnosis of atrial fibrillation. Applying TOAST criteria, 59 strokes (20.3%) were cardioembolic, 54 strokes (18.6%) were secondary to greater than 50% stenosis of the ipsilateral internal carotid artery, 42 strokes (14.4%) had a negative evaluation that met criteria for embolic stroke of undetermined source, and 21 strokes (7.2%) were secondary to small vessel disease. There were significantly fewer cardioembolic strokes (hazard ratio [HR], 0.40 [95% CI, 0.20-0.78]; P = .005) and embolic strokes of undetermined source (HR, 0.30 [95% CI, 0.12-0.74]; P = .006) in the combination therapy group compared with the aspirin-only group. A trend for reduction in strokes secondary to small vessel disease (HR, 0.36 [95% CI, 0.12-1.14]; P = .07) was not statistically significant. No significant difference was observed between the 2 groups in strokes secondary to greater than 50% carotid artery stenosis (HR, 0.85 [95% CI, 0.45-1.60]; P = .61). Rivaroxaban, 5 mg, twice daily showed a trend for reducing cardioembolic strokes compared with aspirin (HR, 0.57 [95% CI, 0.31-1.03]; P = .06) but was not associated with reducing other stroke subtypes.
Conclusions and Relevance
For patients with systemic atherosclerosis, low-dose rivaroxaban plus aspirin was associated with large, significant reductions in cardioembolic strokes and embolic strokes of undetermined source. However, these results of exploratory analysis need to be independently confirmed before influencing clinical practice.
Trial Registration
ClinicalTrials.gov identifier: NCT01776424.",2020,"There were significantly fewer cardioembolic strokes (hazard ratio [HR], 0.40 [95% CI, 0.20-0.78]; P = .005) and embolic strokes of undetermined source (HR, 0.30","['33 countries from March 12, 2013, to May 10, 2016', '49 patients (16.8%) received a diagnosis of atrial fibrillation', 'patients with systemic atherosclerosis', 'Patients with stable atherosclerotic vascular disease were eligible, and a total of 27\u202f395 participants were randomized and followed up to February 6, 2017', '291 patients (66 women; mean [SD] age, 69.4 [8.5] years; 43 [14.8%] had a previous nonlacunar stroke) experienced an ischemic stroke', 'and Ischemic Stroke Subtypes']","['Rivaroxaban With or Without Aspirin', 'rivaroxaban', 'rivaroxaban with or without aspirin', 'placebo', 'TOAST', 'aspirin', 'Rivaroxaban', 'rivaroxaban plus aspirin']","['Measures\n\n\nRisk of ischemic stroke subtypes during follow-up', 'cardioembolic strokes', 'cardioembolic strokes and embolic strokes', 'embolic strokes', 'ischemic strokes']","[{'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517591', 'cui_str': '16.8 (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1531624', 'cui_str': 'Cardioembolic stroke'}, {'cui': 'C0262469', 'cui_str': 'Embolic stroke (disorder)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}]",59.0,0.590201,"There were significantly fewer cardioembolic strokes (hazard ratio [HR], 0.40 [95% CI, 0.20-0.78]; P = .005) and embolic strokes of undetermined source (HR, 0.30","[{'ForeName': 'Kanjana S', 'Initials': 'KS', 'LastName': 'Perera', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kelvin K H', 'Initials': 'KKH', 'LastName': 'Ng', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sumiti', 'Initials': 'S', 'LastName': 'Nayar', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Catanese', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Dyal', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Bosch', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA neurology,['10.1001/jamaneurol.2019.2984']
729,30256758,"The response of meteorin-like hormone and interleukin-4 in overweight women during exercise in temperate, warm and cold water.","Background Meteorin-like hormone (Metrnl) and interleukin-4 (IL-4) are protein molecules that stimulate the production of brown adipose tissue to improve diseases such as type 2 diabetes and obesity. The aim of this study was to investigate the response of Metrnl protein and IL-4 in overweight women during exercise in temperate, warm and cold water. Materials and methods Thirteen overweight young women (mean age 25.21 ± 3.27 years, body mass index 26.43 ± 1.34 kg/m2) were selected randomly and performed three sessions of interval exercise (40 min per session, 65% of maximum oxygen consumption) in non-consecutive days in temperate (24-25 °C), warm (36.5-37.5 °C) and cold (16.5-17.5 °C) water. Blood sampling was done immediately before and after exercise. Results The Metrnl level significantly increased after exercise in temperate and warm water (p = 0.0001) and significantly decreased in cold water (p = 0.0001). IL-4 level significantly increased after exercise in warm water (p = 0.003), while there was no significant change after exercise in temperate and cold water. Conclusions Exercise in warm water appears to stimulate and accumulate immune cells compared to temperate and cold water. This feature can be used to stimulate the production of hormones such as Metrnl and IL-4 to enhance brown fat, although more studies are needed in this regard.",2018,Results The Metrnl level significantly increased after exercise in temperate and warm water (p = 0.0001) and significantly decreased in cold water (p = 0.0001).,"['Thirteen overweight young women (mean age 25.21 ± 3.27 years, body mass index 26.43 ± 1.34 kg/m2', 'overweight women during exercise in temperate, warm and cold water']","['Metrnl protein and IL-4', ' Meteorin-like hormone (Metrnl) and interleukin-4 (IL-4', 'interval exercise (40 min per session, 65% of maximum oxygen consumption']","['IL-4 level', 'Metrnl level']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517501', 'cui_str': '1.34'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}]","[{'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",13.0,0.0366503,Results The Metrnl level significantly increased after exercise in temperate and warm water (p = 0.0001) and significantly decreased in cold water (p = 0.0001).,"[{'ForeName': 'Marziyeh', 'Initials': 'M', 'LastName': 'Saghebjoo', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Einaloo', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Mogharnasi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Ahmadabadi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Birjand, Birjand, Iran.'}]",Hormone molecular biology and clinical investigation,['10.1515/hmbci-2018-0027']
730,29979912,Physical therapist decision-making in managing plantar heel pain: cases from a pragmatic randomized clinical trial.,"INTRODUCTION
Plantar heel pain (PHP) is a common condition managed by physical therapists that can, at times, be difficult to treat. Management of PHP is complicated by a variety of pathoanatomic features associated with PHP in addition to several treatment approaches with varying efficacy. Although clinical guidelines and clinical trial data support a general approach to management, the current literature is limited in case-specific descriptions of PHP management that addresses unique combinations of pathoanatomical, physical, and psychosocial factors that are associated with PHP. Purpose : The purpose of this case series is to describe physical therapist decision-making of individualized multimodal treatment for PHP cases presenting with varied clinical presentations. Treatment incorporated clinical guidelines and recent evidence including a combination of manual therapy, patient education, stretching, resistance training, and neurodynamic interventions. A common clinical decision-making framework was used to progress individualized treatment from a focus on symptom modulation initially to increased load tolerance of involved tissues and graded activity. In each case, patients met their individual goals and demonstrated clinically meaningful improvements in pain, function, and global rating of change that were maintained at the 1-2-year follow-up. Implications : This case series provides details of physical therapist management of a variety of PHP clinical presentations that can be used to complement clinical practice guidelines in the management of PHP.",2020,"In each case, patients met their individual goals and demonstrated clinically meaningful improvements in pain, function, and global rating of change that were maintained at the 1-2-year follow-up.
","['managing plantar heel pain', 'PHP cases presenting with varied clinical presentations']",['Physical therapist decision-making'],"['pain, function, and global rating of change']","[{'cui': 'C0231786', 'cui_str': 'Plantar heel pain (finding)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapists'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0391922,"In each case, patients met their individual goals and demonstrated clinically meaningful improvements in pain, function, and global rating of change that were maintained at the 1-2-year follow-up.
","[{'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'McClinton', 'Affiliation': 'Doctor of Physical Therapy Program, Des Moines University , Des Moines, IA, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Heiderscheit', 'Affiliation': 'Departments of Orthopedics & Rehabilitation and Biomedical Engineering, and Doctor of Physical Therapy Program, University of Wisconsin-Madison , Madison, WI, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'McPoil', 'Affiliation': 'School of Physical Therapy, Regis University , Denver, CO, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Flynn', 'Affiliation': 'School of Physical Therapy, South College , Knoxville, TN, USA.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1490941']
731,29952687,Physiotherapists' experiences with a blended osteoarthritis intervention: a mixed methods study.,"INTRODUCTION
E-Exercise is an effective 12-week blended intervention consisting of around five face-to-face physiotherapy sessions and a web-based application for patients with hip/knee osteoarthritis. In order to facilitate effective implementation of e-Exercise, this study aims to identify physiotherapists' experiences and determinants related to the usage of e-Exercise. Methods : An explanatory sequential mixed methods design embedded in a randomized controlled trial comparing e-Exercise with usual physiotherapy in patients with hip/knee osteoarthritis. Usage of e-Exercise was based on recruitment rates of 123 physiotherapists allocated to e-Exercise and objective web-based application usage data. Experiences and determinants related to e-Exercise usage were investigated with a questionnaire and clarified with semi-structured interviews. Results : Of the 123 physiotherapists allocated to e-Exercise, 54 recruited more than one eligible patient, of whom 10 physiotherapists continued using e-Exercise after the study period. Physiotherapists had mixed experiences with e-Exercise. Determinants related to intervention usage were appropriateness, added value, time, workload, professional autonomy, environmental factors, and financial consequences. Physiotherapists recommended to improve the ability to tailor e-Exercise to the individual needs of the patient patients' individual needs. Discussion : Determinants related to the usage of e-Exercise provided valuable information for the implementation of e-Exercise on broader scale. Most importantly, the flexibility of e-Exercise needs to be improved. Next, there is a need for education on how to integrate an online program within physiotherapy.",2020,"Determinants related to intervention usage were appropriateness, added value, time, workload, professional autonomy, environmental factors, and financial consequences.","['patients with hip/knee osteoarthritis', '123 physiotherapists allocated to e-Exercise, 54 recruited more than one eligible patient, of whom 10 physiotherapists continued using e-Exercise after the study period']","['e-Exercise with usual physiotherapy', 'blended osteoarthritis intervention']","['added value, time, workload, professional autonomy, environmental factors, and financial consequences']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0085518', 'cui_str': 'Professional Autonomy'}]",,0.0450163,"Determinants related to intervention usage were appropriateness, added value, time, workload, professional autonomy, environmental factors, and financial consequences.","[{'ForeName': 'Corelien J J', 'Initials': 'CJJ', 'LastName': 'Kloek', 'Affiliation': 'School of Social and Behavioral Sciences, Tilburg University , Tilburg, The Netherlands.'}, {'ForeName': 'Daniël', 'Initials': 'D', 'LastName': 'Bossen', 'Affiliation': 'ACHIEVE Centre of Expertise, Faculty of Health, Amsterdam University of Applied Sciences , Amsterdam, The Netherlands.'}, {'ForeName': 'Herman J', 'Initials': 'HJ', 'LastName': 'de Vries', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL) , Utrecht, the Netherlands.'}, {'ForeName': 'Dinny H', 'Initials': 'DH', 'LastName': 'de Bakker', 'Affiliation': 'School of Social and Behavioral Sciences, Tilburg University , Tilburg, The Netherlands.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Veenhof', 'Affiliation': 'Department of Rehabilitation, Physical Therapy Science & Sports, Brain Center Rudolf Magnus, University Medical Center Utrecht , Utrecht, the Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Dekker', 'Affiliation': 'Department of Rehabilitation Medicine & Department of Psychiatry, EMGO Institute, VU University Medical Center Amsterdam , Amsterdam, the Netherlands.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1489926']
732,31570733,Apatinib Mesylate in the treatment of advanced progressed lung adenocarcinoma patients with EGFR-TKI resistance -A Multicenter Randomized Trial.,"Few pieces of evidence have been published on the use of Apatinib Mesylate (AM) against EGFR-TKI resistance in lung adenocarcinoma (LA) patients. Here, we investigate the clinical efficacy and safety of AM in the treatment of advanced progressed epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) resistant LA patients. We conducted a double-blind, randomized controlled trial in 68 patients admitted to 18 hospitals of Anhui province in China. The efficacy and safety of AM treatment were evaluated in terms of progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR), as well as related adverse events (AE). A literature knowledge database analysis and a pathway model reconstruction were performed to decipher the relevant mechanism may be involved. Our results showed that, compared to the control group, AM presented improved efficacy in PFS (P = 0.033), ORR (P < 0.001), and DCR (P < 0.001). No significant difference was observed between case and control group in terms of AE, and no drug-related death occurred. Pathway analysis supports that Apatinib can be repurposed for the treatment of LA. Our results suggested that AM could be a potential option for advanced progressed LA patients to combat EGFR-TKI resistance.",2019,"Our results showed that, compared to the control group, AM presented improved efficacy in PFS (P = 0.033), ORR (P < 0.001), and DCR (P < 0.001).","['68 patients admitted to 18 hospitals of Anhui province in China', 'lung adenocarcinoma (LA) patients', 'advanced progressed lung adenocarcinoma patients with EGFR-TKI resistance -A']","['AM', 'Apatinib Mesylate']","['efficacy in PFS', 'ORR', 'progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR), as well as related adverse events (AE', 'efficacy and safety', 'DCR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of Lung'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C4547969', 'cui_str': 'apatinib mesylate'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",68.0,0.0629498,"Our results showed that, compared to the control group, AM presented improved efficacy in PFS (P = 0.033), ORR (P < 0.001), and DCR (P < 0.001).","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Fang', 'Affiliation': ""Department of Respiratory, the People's Hospital of Tongling, Tongling, Anhui province, 244000, China. fangping1964@126.com.""}, {'ForeName': 'Liqin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory, Yijishan Hospital of Wannan Medical College, No. 2 Zheshan West Road, Wuhu, Anhui Province, 241000, China.'}, {'ForeName': 'Xianru', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory, Tongling Municipal Hospital, No. 2999 Changjiang West Road, Tongling, Anhui Province, 244099, China.'}, {'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ""Department of Respiratory, Anqing First People's Hospital, No. 42 Xiaosu Road, Anqing, Anhui Province, 246000, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Department of Respiratory, Xuancheng People's Hospital, No. 15 Huancheng North Road, Xuancheng, Anhui Province, 242000, China.""}, {'ForeName': 'Qi-An', 'Initials': 'QA', 'LastName': 'Jiang', 'Affiliation': 'Department of Respiratory, Anqing Municipal Hospital, No.172 Renmin Road, Yingjiang District, Anqing, Anhui Province, 246000, China.'}, {'ForeName': 'Mingbao', 'Initials': 'M', 'LastName': 'Zha', 'Affiliation': 'Department of Respiratory, Wuhu City Hospital of Traditional Chinese Medicine, No. 240 Jiuhua Middle Road, Jinghu District, Wuhu, Anhui Province, 2461002, China.'}, {'ForeName': 'Anastasia P', 'Initials': 'AP', 'LastName': 'Nesterova', 'Affiliation': 'Department of Biology Solution, Elsevier, 1150 18th St NW, Washington, DC 20036, USA.'}, {'ForeName': 'Hongbao', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Biology Solution, Elsevier, 1150 18th St NW, Washington, DC 20036, USA. caohon2010@gmail.com.'}]",Scientific reports,['10.1038/s41598-019-50350-6']
733,31504572,Reduction of inappropriate medication in older populations by electronic decision support (the PRIMA-eDS project): a survey of general practitioners' experiences.,"OBJECTIVE
We sought to investigate the experiences of general practitioners (GPs) with an electronic decision support tool to reduce inappropriate polypharmacy in older patients (the PRIMA-eDS [Polypharmacy in chronic diseases: Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support] tool) in a multinational sample of GPs and to quantify the findings from a prior qualitative study on the PRIMA-eDS-tool.
MATERIALS AND METHODS
Alongside the cluster randomized controlled PRIMA-eDS trial, a survey was conducted in all 5 participating study centers (Bolzano, Italy; Manchester, United Kingdom; Salzburg, Austria; Rostock, Germany; and Witten, Germany) between October 2016 and July 2017. Data were analyzed using descriptive statistics and chi-square tests.
RESULTS
Ninety-one (n = 160) percent of the 176 questionnaires were returned. Thirty-two percent of the respondents reported that they did not cease drugs because of the medication check. The 68% who had discontinued drugs comprise 57% who had stopped on average 1 drug and 11% who had stopped 2 drugs or more per patient. The PRIMA-eDS tool was found to be useful (69%) and the recommendations were found to help to increase awareness (86%). The greatest barrier to implementing deprescribing recommendations was the perceived necessity of the medication (69%). The majority of respondents (65%) would use the electronic medication check in routine practice if it was part of the electronic health record.
CONCLUSIONS
GPs generally viewed the PRIMA-eDS medication check as useful and as informative. Recommendations were not always followed due to various reasons. Many GPs would use the medication check if integrated into the electronic health record.",2019,The PRIMA-eDS tool was found to be useful (69%) and the recommendations were found to help to increase awareness (86%).,"['all 5 participating study centers (Bolzano, Italy; Manchester, United Kingdom; Salzburg, Austria; Rostock, Germany; and Witten, Germany) between October 2016 and July 2017', 'The 68% who had discontinued drugs comprise 57% who had stopped on average 1 drug and 11% who had stopped 2 drugs or more per patient', 'Ninety-one (n\u2009=\u2009160) percent of the 176 questionnaires were returned', 'older patients (the PRIMA-eDS [Polypharmacy in chronic diseases']",['general practitioners (GPs) with an electronic decision support tool'],[],"[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2922974', 'cui_str': 'Polymedication'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}]","[{'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}]",[],,0.0298842,The PRIMA-eDS tool was found to be useful (69%) and the recommendations were found to help to increase awareness (86%).,"[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Rieckert', 'Affiliation': 'Department of Human Medicine, Institute of General Practice and Family Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Anne-Lisa', 'Initials': 'AL', 'LastName': 'Teichmann', 'Affiliation': 'Department of Human Medicine, Institute of General Practice and Family Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Drewelow', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Kriechmayr', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Piccoliori', 'Affiliation': 'South Tyrolean Academy for General Practice, Bolzano, Italy.'}, {'ForeName': 'Adrine', 'Initials': 'A', 'LastName': 'Woodham', 'Affiliation': 'Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Sönnichsen', 'Affiliation': 'Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz104']
734,30015546,The immediate and 1-week effects of mid-thoracic thrust manipulation on lower extremity passive range of motion.,"BACKGROUND
Research suggests that spinal manipulation may effect motion. Less clear is whether this effect is limited to localized responses or may involve generalizable changes. Objective : To determine whether Mid-thoracic manipulation (MTM) would result in a significant change in the lower extremity passive straight leg raise (PSLR) range of motion immediately and after 1 week. Methods : Twenty-three healthy subjects were randomly assigned in a double-blinded study. An experimental group received MTM and a control group received a sham intervention. PSLR measurements were taken prior to, immediately after, and one week after the intervention. Results : Mixed model repeated measure analysis of variance was used to determine that there was a significant interaction between MTM and time ( F (2, 21) = 3.84, p < 0.05). Post hoc tests revealed a significant difference between the pretest to immediate posttest values ( p < 0.05, SE = 1.47). PSLR in the MTM group increased 10.3° while the sham group increased 1.9°. Difference was non-significant between pretest and 1-week follow-up ( p = 0.129, SE = 2.46). Conclusions : MTM may immediately increase lower extremity passive range of motion, but the effect was lost by the 1-week follow-up. This supports evolving research suggesting that spinal manipulation may have a generalized but transient physiological effect.",2020,"Post hoc tests revealed a significant difference between the pretest to immediate posttest values (p < 0.05, SE = 1.47).",['Twenty-three healthy subjects'],"['mid-thoracic thrust manipulation', 'Mid-thoracic manipulation (MTM', 'MTM', 'sham intervention']","['extremity passive range of motion', 'PSLR', 'lower extremity passive range of motion']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0079991', 'cui_str': 'Passive Range of Motion'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",23.0,0.0855578,"Post hoc tests revealed a significant difference between the pretest to immediate posttest values (p < 0.05, SE = 1.47).","[{'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Sueki', 'Affiliation': 'Department of Physical Therapy, Azusa Pacific University , Azusa, CA, USA.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Almaria', 'Affiliation': 'Peak Sports Medicine and Rehabilitation , Phoenix, AZ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bender', 'Affiliation': 'Performax Elite , Burbank, CA, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'McConnell', 'Affiliation': 'Healthcare Partners , Torrance, CA, USA.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1492056']
735,29985724,Effects of kinesio taping on neuromuscular performance and pain of individuals affected by patellofemoral pain: A randomized controlled trial.,"Patellofemoral pain (PFP) is one of the most frequent musculoskeletal dysfunctions in the knee and its treatment is controversial. This study analyzed the effects of Kinesio Taping (KT) immediately and 72 hours after its application on the electromyographic (EMG) activity of the vastus medialis oblique (VMO) muscle, on the isokinetic performance of the quadriceps femoris and on the pain of subjects with PFP. Fifty-four participants were divided into three groups and performed one of the following protocols: (1) control group (CG)-remained at rest; (2) KT tension group (TG)-KT application with tension in the VMO region; and (3) KT without tension group (WTG)-KT application without tension in the same region. VMO and vastus lateralis (VL) EMG activity (RMS and onset), isokinetic performance and pain intensity were evaluated at three moments: before KT application, immediately after and 72 hours after. A mixed model ANOVA was used for statistical analysis with a significance level of 5% ( p ≤ 0.05). No differences between the evaluated groups were found in relation to EMG variables and isokinetic performance. A reduction in pain intensity was found in the WTG in comparison to CG, after 72 hours. KT does not alter EMG parameters nor the isokinetic performance of subjects with PFP. However, we noticed reduced pain in the group submitted to the technique without tension 72 hours after its application.",2020,"A reduction in pain intensity was found in the WTG in comparison to CG, after 72 hours.","['individuals affected by patellofemoral pain', 'subjects with PFP', 'Fifty-four participants']","['kinesio taping', 'Kinesio Taping (KT', 'control group (CG)-remained at rest; (2) KT tension group (TG)-KT application with tension in the VMO region; and (3) KT without tension group (WTG)-KT application without tension in the same region']","['neuromuscular performance and pain', 'Patellofemoral pain (PFP', 'pain', 'relation to EMG variables and isokinetic performance', 'electromyographic (EMG) activity of the vastus medialis oblique (VMO) muscle', 'pain intensity', 'VMO and vastus lateralis (VL) EMG activity (RMS and onset), isokinetic performance and pain intensity', 'isokinetic performance']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0224445', 'cui_str': 'Vastus Medialis'}, {'cui': 'C0205315', 'cui_str': 'Oblique (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",54.0,0.0187951,"A reduction in pain intensity was found in the WTG in comparison to CG, after 72 hours.","[{'ForeName': 'Samara Alencar', 'Initials': 'SA', 'LastName': 'Melo', 'Affiliation': 'Department of Physiotherapy, Federal University of Rio Grande do Norte (UFRN) , Natal, Brazil.'}, {'ForeName': 'Liane de Brito', 'Initials': 'LB', 'LastName': 'Macedo', 'Affiliation': 'Department of Physiotherapy, Federal University of Rio Grande do Norte (UFRN) , Natal, Brazil.'}, {'ForeName': 'Daniel Tezoni', 'Initials': 'DT', 'LastName': 'Borges', 'Affiliation': 'Department of Physiotherapy, Federal University of Rio Grande do Norte (UFRN) , Natal, Brazil.'}, {'ForeName': 'Jamilson Simões', 'Initials': 'JS', 'LastName': 'Brasileiro', 'Affiliation': 'Department of Physiotherapy, Federal University of Rio Grande do Norte (UFRN) , Natal, Brazil.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1492657']
736,29907079,A Comparison of Different Intensities of Patient Navigation After Abnormal Mammography.,"Background . Patient navigation is a practice strategy to address barriers to timely diagnosis and treatment of cancer. The aim of this study was to examine the effectiveness of varying intensities of patient navigation and timely diagnostic resolution after abnormal mammography. Method . This is a secondary analysis of a subset of women with an abnormal screening or diagnostic mammogram who participated in the ""patient navigation in medically underserved areas"" 5-year randomized trial. We compared timely diagnostic resolution in women assigned to different intensities of patient navigation including, full navigation intervention, no contact with navigators, or limited contact with navigators. Results . The sample included 1,725 women with abnormal mammogram results. Women who interacted with patient navigators had significantly fewer days to diagnostic resolution after abnormal mammography compared with women who did not interact with patient navigators. Discussion . Results from our study suggest that even limited contact with navigators encourages women to seek more timely diagnostic resolution after an abnormal mammogram, which may offer a low-cost practice strategy to improve timely diagnosis for disadvantaged and underserved women.",2019,"Women who interacted with patient navigators had significantly fewer days to diagnostic resolution after abnormal mammography compared with women who did not interact with patient navigators.
","['1,725 women with abnormal mammogram results', 'disadvantaged and underserved women', 'women with an abnormal screening or diagnostic mammogram who participated in the ""patient navigation in medically underserved areas"" 5-year randomized trial']","['Patient Navigation', 'full navigation intervention, no contact with navigators, or limited contact with navigators']",['diagnostic resolution'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0262365', 'cui_str': 'Mammography abnormal (finding)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0411881', 'cui_str': 'Mammogram - symptomatic (procedure)'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}, {'cui': 'C0025112', 'cui_str': 'Medically Underserved Area'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",1725.0,0.0861541,"Women who interacted with patient navigators had significantly fewer days to diagnostic resolution after abnormal mammography compared with women who did not interact with patient navigators.
","[{'ForeName': 'Anne Elizabeth', 'Initials': 'AE', 'LastName': 'Glassgow', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Yamile', 'Initials': 'Y', 'LastName': 'Molina', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Sage', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Campbell', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Darnell', 'Affiliation': 'Loyola University, Maywood, IL, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Calhoun', 'Affiliation': 'University of Arizona, Tucson, AZ, USA.'}]",Health promotion practice,['10.1177/1524839918782168']
737,29748721,Impact of acute dynamic exercise on radial artery low-flow mediated constriction in humans.,"PURPOSE
A ""low-flow mediated constriction"" (L-FMC) is evoked in the radial artery by the inflation of an ipsilateral wrist cuff to a supra-systolic pressure. We sought to test the hypothesis that the radial artery L-FMC response is augmented immediately following acute dynamic leg exercise in young healthy individuals.
METHODS
Ten healthy and recreationally active men (23 ± 4 years) undertook a 30-min trial of incremental dynamic leg cycling exercise (10 min at 50, 100 and 150 W) and a 30-min time control trial (seated rest). Trials were randomly assigned and performed on separate days. Radial artery characteristics (diameter, blood flow and shear rate) were assessed throughout each trial, with L-FMC and flow-mediated vasodilatation (FMD) assessments conducted prior to and immediately following (10 min) trials.
RESULTS
Dynamic leg cycling exercise increased radial artery blood flow, along with mean, retrograde and anterograde shear rate (P < 0.05). Blood flow profiles were unchanged during the time control trial (P > 0.05). Following exercise L-FMC was increased (mean [SD]; - 5.6 [3.3] vs. - 10.1 [3.8] %, P < 0.05), while it was not different in the time control condition (- 8.1 [3.2] vs. - 6.7 [3.4] %, P > 0.05). FMD was not different following either the exercise or time control trials (P > 0.05), but the composite end-point of L-FMC + FMD was enhanced post-exercise (P < 0.05).
CONCLUSIONS
Dynamic exercise with a large muscle mass acutely augments the vasoconstrictor response of the radial artery in response to a reduction in blood flow (L-FMC) in young healthy individuals. The time course of this post-exercise response and the underlying vasoregulatory mechanisms require elucidation.",2018,"FMD was not different following either the exercise or time control trials (P > 0.05), but the composite end-point of L-FMC + FMD was enhanced post-exercise (P < 0.05).
","['Ten healthy and recreationally active men (23\u2009±\u20094\xa0years) undertook a 30-min trial of', 'humans', 'young healthy individuals']","['acute dynamic exercise', 'low-flow mediated constriction"" (L-FMC', 'incremental dynamic leg cycling exercise', 'Dynamic exercise']","['FMD', 'radial artery blood flow', 'blood flow (L-FMC', 'Radial artery characteristics (diameter, blood flow and shear rate', 'Blood flow profiles', 'mean, retrograde and anterograde shear rate']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0009813', 'cui_str': 'Constriction'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction (qualifier value)'}]",10.0,0.0944705,"FMD was not different following either the exercise or time control trials (P > 0.05), but the composite end-point of L-FMC + FMD was enhanced post-exercise (P < 0.05).
","[{'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Elliott', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Alsalahi', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Edgbaston, Birmingham, UK.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Fisher', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Edgbaston, Birmingham, UK. j.p.fisher@bham.ac.uk.'}]",European journal of applied physiology,['10.1007/s00421-018-3876-1']
738,29794257,"Integrated training (practicing, peer clinical training and OSCE assessment): a ladder to promote learning and training.","Introduction The teaching-learning process plays an effective role in training nursing students. Devising novel methods can lead to achievement of educational objectives as well as promotion of the clinical and practical training. The present study is aimed to determine the effect of integrated training, including practicing, peer clinical training and objective structured clinical examination (OSCE) assessment. Methods The interventional study was conducted on 58 freshman students. Two groups underwent a five-stage educational process; so that, all the students were trained and practiced in the skills lab, and their practical skills were investigated via the OSCE test. Afterwards, for clinical training in hospital, they were randomly divided into two groups of routine training (n = 26) and the peer-learning method (n = 32). Subsequently, in order to investigate the outcomes of the process, the OSCE test scores of the two training groups were compared both before and after the apprenticeship course. Results Scores of all the students were increased significantly at the end of the semester, but in terms of the total score of the clinical skills (14.79 ± 1.52 vs. 18.52 ± 0.84), the difference was insignificant (p = 0.29). Conclusion Training clinical skills along with OSCE practice and assessment can improve the nursing students' learning as well as their practical and clinical performance. Improvement of the students' performance can lead to high-quality care nursing.",2018,"Results Scores of all the students were increased significantly at the end of the semester, but in terms of the total score of the clinical skills (14.79 ± 1.52 vs. 18.52 ± 0.84), the difference was insignificant (p = 0.29).","['58 freshman students', 'training nursing students']","['routine training', 'Integrated training (practicing, peer clinical training and OSCE assessment): a ladder to promote learning and training', 'integrated training, including practicing, peer clinical training and objective structured clinical examination (OSCE) assessment']","['OSCE test scores', 'total score of the clinical skills']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336762', 'cui_str': 'Ladder, device (physical object)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008973', 'cui_str': 'Clinical Skill'}]",58.0,0.014928,"Results Scores of all the students were increased significantly at the end of the semester, but in terms of the total score of the clinical skills (14.79 ± 1.52 vs. 18.52 ± 0.84), the difference was insignificant (p = 0.29).","[{'ForeName': 'Mahlegha', 'Initials': 'M', 'LastName': 'Dehghan', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Fatemeh Ghaedi', 'Initials': 'FG', 'LastName': 'Heidari', 'Affiliation': 'School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Karzari', 'Affiliation': 'Kerman branch of Azad University, Kerman, Iran.'}, {'ForeName': 'Parvin Mangolian', 'Initials': 'PM', 'LastName': 'Shahrbabaki', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2017-0222']
739,29984622,Doubly robust weighted log-rank tests and Renyi-type tests under non-random treatment assignment and dependent censoring.,"The log-rank test is widely used to test difference in event time distribution between treatment groups. However, if subjects are not randomly assigned to treatment groups, which is often the case in observation studies, the log-rank test is not asymptotically correct for detecting group survival difference due to the imbalance of confounding variables between groups. We develop a class of modified weighted log-rank tests and Renyi-type tests for two-sample survival comparison under non-random treatment assignment. The new tests can also account for non-random censoring that depends on baseline covariates. The proposed methods involve building working models for treatment assignment, cause-specific hazard of dependent censoring, and the time to event. We prove that, when either the models for treatment assignment and dependent censoring or the model for the event time is true, the new tests are asymptotically correct, i.e. being doubly robust. Numerical experiments demonstrate the tests' double-robustness property in finite samples of realistic sizes, and also show that the doubly robust log-rank test is at least as powerful as the regular log-rank test when the treatment assignment is random and there is no dependent censoring. An application to a kidney transplant data set illustrates the utility of the proposed methods.",2019,We develop a class of modified weighted log-rank tests and Renyi-type tests for two-sample survival comparison under non-random treatment assignment.,[],[],[],[],[],[],,0.0344978,We develop a class of modified weighted log-rank tests and Renyi-type tests for two-sample survival comparison under non-random treatment assignment.,"[{'ForeName': 'Chenxi', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, Michigan State University, East Lansing, MI, USA.'}]",Statistical methods in medical research,['10.1177/0962280218785926']
740,31650314,Evaluation of effect of warm local anesthetics on pain perception during dental injections in children: a split-mouth randomized clinical trial.,"OBJECTIVES
The present study evaluates the efficacy of warm local anesthetic (37 °C) administration and injections of local anesthetics at room temperature (21 °C) in reducing pain during injections in children undergoing dental procedures.
MATERIALS AND METHODS
Enrolled for this split-mouth randomized clinical study were 100 children aged 5-8 years. Within the random crossover design selected for the study, each patient was randomly assigned to receive either a body or room temperature local anesthesia in the first session and the other local anesthesia on the second session. During the injection, the Wong-Baker Faces Pain Rating Scale was used as a subjective measure of discomfort, and heart rate as an objective measure. The Face, Legs, Arms, Cry, and Consolability (FLACC) scale was used to record the child's pain, based on the perception of the dental assistant. The data were analyzed using a Wilcoxon sign rank test and a paired t test.
RESULTS
Based on the score of the Wong-Baker Faces Pain Rating Scale, the FLACC scale, and heart rate, the sensation of pain during dental injection in both girls and boys is statistically significantly lower at body temperature than at room temperature (p < 0.05).
CONCLUSIONS
It was determined that the application of local anesthetic at body temperature reduces dental injection pain significantly when compared with local anesthetics administered at room temperature.
CLINICAL RELEVANCE
The successful management of dental injection pain is an important issue during dental procedures in children. Accordingly, warming the local anesthesia prior to use in children can be recommended to clinicians.",2020,"It was determined that the application of local anesthetic at body temperature reduces dental injection pain significantly when compared with local anesthetics administered at room temperature.
","['children', 'children undergoing dental procedures', '100 children aged 5-8 years']","['warm local anesthetics', 'body or room temperature local anesthesia', 'warm local anesthetic (37 °C) administration and injections of local anesthetics at room temperature (21 °C']","['Face, Legs, Arms, Cry, and Consolability (FLACC) scale', 'dental injection pain', 'subjective measure of discomfort, and heart rate', 'pain', 'pain perception', 'score of the Wong-Baker Faces Pain Rating Scale, the FLACC scale, and heart rate, the sensation of pain', 'Wong-Baker Faces Pain Rating Scale']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0222045'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0015468', 'cui_str': 'Face Pain'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}]",100.0,0.0334838,"It was determined that the application of local anesthetic at body temperature reduces dental injection pain significantly when compared with local anesthetics administered at room temperature.
","[{'ForeName': 'Hüsniye', 'Initials': 'H', 'LastName': 'Gümüş', 'Affiliation': 'Faculty of Dentistry, Department of Pediatric Dentistry, Erciyes University, Kayseri, Turkey. husniyegumus@yahoo.com.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Aydinbelge', 'Affiliation': 'Faculty of Dentistry, Department of Pediatric Dentistry, Erciyes University, Kayseri, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-019-03086-6']
741,31650315,"Effectiveness of a reciprocating single file, single cone endodontic treatment approach: a randomized controlled pragmatic clinical trial.","OBJECTIVES
To compare the root filling quality, the sealer extrusion, and the healing rates of apical lesions addressed via two endodontic treatment approaches. The hypothesis tested was that both techniques present similar apical periodontitis healing results.
MATERIALS AND METHODS
This study was a parallel-design, pragmatic, and randomized clinical trial. One hundred twenty anterior teeth with necrotic pulps and apical periodontitis were randomly allocated to be either instrumented with hand files and obturated with the lateral compaction technique or instrumented with a single file in a reciprocating movement and obturated with a single-cone technique. The root canal filling quality, the occurrence of sealer extrusion, and apical periodontitis healing were the outcomes of interest. Data were analyzed through chi-square analysis, and the odds ratio for healing was adjusted using a logistic regression model (α = 0.05).
RESULTS
No significant differences were observed between the endodontic techniques regarding the root filling quality or sealer extrusion. Six months after treatment, both endodontic techniques presented equivalent results regarding apical periodontitis healing. The healing rate was affected only by the periapical status at baseline.
CONCLUSIONS
The obturation of the root canal of the anterior teeth using reciprocating file-matched single cones presented a similar quality to that obtained with manual instrumentation followed by the lateral condensation technique. Similar healing rates of apical lesions were also observed.
CLINICAL RELEVANCE
For treating anterior teeth with apical periodontitis, a reciprocating single-file, single-treatment protocol was as effective as a traditional protocol combining hand instrumentation and the lateral compaction obturation technique.",2020,No significant differences were observed between the endodontic techniques regarding the root filling quality or sealer extrusion.,"['For treating anterior teeth with apical periodontitis', 'One hundred twenty anterior teeth with necrotic pulps and apical periodontitis']",['instrumented with hand files and obturated with the lateral compaction technique or instrumented with a single file in a reciprocating movement and obturated with a single-cone technique'],"['healing rates of apical lesions', 'root canal filling quality, the occurrence of sealer extrusion, and apical periodontitis healing', 'root filling quality or sealer extrusion', 'apical periodontitis healing', 'healing rate', 'odds ratio for healing']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0031030', 'cui_str': 'Periodontitis, Apical'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0180853', 'cui_str': 'File, device (physical object)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0393983', 'cui_str': 'Cerebellar Herniation'}]","[{'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0035848', 'cui_str': 'Endodontic Obturation'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0449942', 'cui_str': 'Sealer (attribute)'}, {'cui': 'C0443213', 'cui_str': 'Extrusion (qualifier value)'}, {'cui': 'C0031030', 'cui_str': 'Periodontitis, Apical'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",120.0,0.082917,No significant differences were observed between the endodontic techniques regarding the root filling quality or sealer extrusion.,"[{'ForeName': 'Fabricio Eneas Diniz', 'Initials': 'FED', 'LastName': 'de Figueiredo', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Sergipe, Rua Cláudio Batista s/n, Sanatorio, Bairro Sanatório, Aracaju, SE, CEP 49060-100, Brazil. fabricioeneas@hotmail.com.'}, {'ForeName': 'Laila F', 'Initials': 'LF', 'LastName': 'Lima', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Sergipe, Rua Cláudio Batista s/n, Sanatorio, Aracaju, SE, 49060-100, Brazil.'}, {'ForeName': 'Ludmila S', 'Initials': 'LS', 'LastName': 'Oliveira', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Sergipe, Rua Cláudio Batista s/n, Sanatorio, Aracaju, SE, 49060-100, Brazil.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Dentistry, Federal University of Sergipe, Rua Cláudio Batista s/n, Sanatorio, Aracaju, SE, 49060-100, Brazil.'}, {'ForeName': 'Marcos B', 'Initials': 'MB', 'LastName': 'Correa', 'Affiliation': 'Department of Restorative Dentistry and Dental Materials, Federal University of Pelotas, 457, Gonçalves Chaves St. 5th floor, Pelotas, RS, 96015-560, Brazil.'}, {'ForeName': 'Manoel', 'Initials': 'M', 'LastName': 'Brito-Junior', 'Affiliation': 'Department of Dentistry, State University of Montes Claros, Av. Dr. Ruy Braga, s/n, Vila Mauriceia, Montes Claros, MG, 39401-089, Brazil.'}, {'ForeName': 'André L', 'Initials': 'AL', 'LastName': 'Faria-E-Silva', 'Affiliation': 'Department of Dentistry, Federal University of Sergipe, Rua Cláudio Batista s/n, Sanatorio, Aracaju, SE, 49060-100, Brazil.'}]",Clinical oral investigations,['10.1007/s00784-019-03077-7']
742,31647280,Virtual grocery shopping and cookie consumption following intranasal insulin or placebo application.,"Insulin receptors are present in brain areas that are involved in the control of hunger and satiety, and intranasal insulin is assumed to have an anorexigenic effect. This known influence of insulin on satiety encouraged us to investigate the effect of intranasal insulin on feeding-related behaviors. The aim of the current study was to explore the influence of 40 IU of intranasal insulin on the grocery shopping behavior and cookie consumption in a group of 30 healthy young men, using a crossover randomized double-blind design. Using a virtual mock supermarket, we tested whether the intranasal administration of insulin influences purchase behavior in comparison to a placebo or control condition. The participants also provided hedonic ratings of food pictures, as well as their subjective feeling of hunger. We calculated an objective measure of hunger from the amount of cookies eaten. In contradiction to our hypotheses, no significant differences regarding ratings, calorie content of purchased food products, and cookie consumption were found between the treatment conditions. Our conclusion is that 40 IU intranasal insulin had no influence on the evaluation of pictured foods in healthy young men in our task. Acknowledging that previous studies have found effects for intranasal insulin and food cue processing, we suggest that future research should focus on chemosensory stimulation or cognitive tasks in behavioral experiments and carefully consider the doses of intranasal insulin. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Our conclusion is that 40 IU intranasal insulin had no influence on the evaluation of pictured foods in healthy young men in our task.,"['30 healthy young men', 'healthy young men']","['intranasal insulin', 'placebo', 'intranasal insulin or placebo application']","['ratings, calorie content of purchased food products, and cookie consumption', 'hedonic ratings of food pictures, as well as their subjective feeling of hunger']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C3853210', 'cui_str': 'Cookie (substance)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}]",2019.0,0.228854,Our conclusion is that 40 IU intranasal insulin had no influence on the evaluation of pictured foods in healthy young men in our task.,"[{'ForeName': 'Rea', 'Initials': 'R', 'LastName': 'Rodriguez-Raecke', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Sommer', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology.'}, {'ForeName': 'Yvonne Felicitas', 'Initials': 'YF', 'LastName': 'Brünner', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology.'}, {'ForeName': 'Franziska Sonja', 'Initials': 'FS', 'LastName': 'Müschenich', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Sijben', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000330']
743,31266353,Sustained responses to lasmiditan: Results from post-hoc analyses of two Phase 3 randomized clinical trials for acute treatment of migraine.,"BACKGROUND
Sustained pain freedom is an important attribute of acute migraine therapies for patients and physicians. Here we report efficacy of the centrally penetrant, highly selective, 5-HT 1F agonist lasmiditan on sustained pain freedom and other outcomes at 24 and 48 hours post-dose.
STUDY DESIGN AND METHODS
Data from the similarly designed, Phase 3, double-blind studies SAMURAI (NCT02439320) and SPARTAN (NCT02605174) were pooled to more precisely estimate efficacy effects in these post-hoc analyses. In both studies, inclusion criteria were 3-8 migraine attacks per month and Migraine Disability Assessment Score of ≥ 11 (at least moderate disability). Patients were randomized equally to lasmiditan 200 mg, 100 mg, 50 mg (50 mg only in SPARTAN), or to placebo. The study drug was to be taken within 4 hours of onset of pain for non-improving headache of at least moderate severity. Sustained pain freedom was defined as being pain free at 2 hours and at the given time point (24 or 48 hours) post-dose without use of additional study drug or migraine medications. Sustained responses were assessed similarly for most bothersome symptom-free, total migraine-free, and disability-free outcomes. For comparisons with previously published data on other acute medications, an additional endpoint of modified sustained pain freedom at 24 hours was defined as being pain free at 2 hours and no moderate-to-severe headache at 24 hours post-dose without use of additional study drug or migraine medications.
RESULTS
Significantly higher proportions of patients treated with lasmiditan versus placebo achieved headache pain freedom at 2 hours post-dose: 200 mg: 35.6%; 100 mg: 29.9%; 50 mg: 28.6%; placebo: 18.3% (all p < 0.001). Sustained pain freedom was significantly higher in patients treated with lasmiditan versus placebo at 24 hours: 200 mg: 21.2%; 100 mg: 16.9%; 50 mg: 17.4%; placebo: 10.3% (all p < 0.01); and at 48 hours: 200 mg: 18.4%; 100 mg: 15.2%; 50 mg: 14.9%; placebo: 9.6% (all p < 0.05). Similar sustained benefits of lasmiditan versus placebo at 24 and 48 hours were noted for most bothersome symptom-free, total migraine-free and disability-free responses. Modified sustained pain freedom at 24 hours was also observed in significantly higher proportions of lasmiditan-treated patients versus placebo: 200 mg: 27.0%; 100 mg: 21.7%; 50 mg: 21.7%; placebo: 12.9% (all p < 0.01).
CONCLUSION
Sustained responses at 24 and 48 hours were noted in significantly more patients treated with lasmiditan versus placebo for several efficacy outcomes including pain freedom, most bothersome symptom-free, total migraine-free and disability-free responses.
CLINICALTRIALS.GOV IDENTIFIER NUMBERS
SAMURAI: NCT02439320; SPARTAN: NCT02605174.",2019,Sustained pain freedom was significantly higher in patients treated with lasmiditan versus placebo at 24 hours: 200 mg: 21.2%; 100 mg: 16.9%; 50 mg: 17.4%; placebo: 10.3% (all p < 0.01); and at 48 hours: 200 mg: 18.4%; 100 mg: 15.2%; 50 mg: 14.9%; placebo: 9.6% (all p < 0.05).,['patients and physicians'],"['SAMURAI', 'placebo', 'lasmiditan 200 mg, 100\u2009mg, 50\u2009mg (50\u2009mg only in SPARTAN), or to placebo', 'centrally penetrant, highly selective, 5-HT 1F agonist lasmiditan', 'lasmiditan versus placebo']","['bothersome symptom-free, total migraine-free, and disability-free outcomes', 'bothersome symptom-free, total migraine-free and disability-free responses', 'pain freedom, most bothersome symptom-free, total migraine-free and disability-free responses', 'headache pain freedom', 'Sustained pain freedom', 'Modified sustained pain freedom']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}]",,0.283391,Sustained pain freedom was significantly higher in patients treated with lasmiditan versus placebo at 24 hours: 200 mg: 21.2%; 100 mg: 16.9%; 50 mg: 17.4%; placebo: 10.3% (all p < 0.01); and at 48 hours: 200 mg: 18.4%; 100 mg: 15.2%; 50 mg: 14.9%; placebo: 9.6% (all p < 0.05).,"[{'ForeName': 'Erin Gautier', 'Initials': 'EG', 'LastName': 'Doty', 'Affiliation': 'Lilly USA, LLC, Indianapolis, IN, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krege', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Covance Chiltern, Princeton, NJ, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Raskin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Rashmi B', 'Initials': 'RB', 'LastName': 'Halker Singh', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Kalidas', 'Affiliation': 'Division of Headache Medicine, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419859313']
744,31498121,"A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Teprenone in Patients with Alzheimer's Disease.","BACKGROUND
Teprenone (geranylgeranylacetone), an anti-ulcer agent, has been reported to inhibit amyloid-β increase, senile plaque formation, and neuronal degeneration, and improve memory in mouse models of Alzheimer's disease (AD).
OBJECTIVE
We conducted a randomized, double-blind, placebo-controlled study to ascertain teprenone's therapeutic ability for AD.
METHODS
Patients with mild to moderate AD, with a Mini-Mental State Examination (MMSE) score of 13 to 26, were randomly allocated into two groups depending on the administered drug: donepezil + placebo (placebo group) and donepezil + teprenone (teprenone group). The primary and secondary endpoints included changes in scores of the Japanese version of the AD Assessment Scale-cognitive subscale (ADAS-J cog) and other evaluations, respectively, including MMSE scores, during a 12-month period after the first administration.
RESULTS
Forty-two and thirty-seven patients were allocated to the teprenone and placebo groups, respectively. ADAS-J cog score changes were not different between groups (placebo, 0.6±0.8; teprenone, 0.4±0.8; p = 0.861). However, MMSE scores significantly improved in the teprenone group (placebo, - 1.2±0.5; teprenone, 0.2±0.5; p = 0.044). Subgroup analysis considering the severity of medial temporal area atrophy revealed that this improvement by teprenone was significant in patients with mild (p = 0.013) but not with severe atrophy (p = 0.611). Adverse events were observed in 17.8 and 10.4% of patients in the placebo and teprenone group, respectively.
CONCLUSION
Teprenone may be effective for AD when administered before atrophy progression in the medial temporal areas.
TRIAL REGISTRATION
UMIN ID: UMIN000016843.",2019,"ADAS-J cog score changes were not different between groups (placebo, 0.6±0.8; teprenone, 0.4±0.8; p = 0.861).","[""Patients with Alzheimer's Disease"", 'Forty-two and thirty-seven patients', 'Patients with mild to moderate AD, with a Mini-Mental State Examination (MMSE) score of 13 to 26']","['Placebo', 'teprenone and placebo', 'Teprenone (geranylgeranylacetone', 'Teprenone', 'placebo', 'donepezil\u200a+ \u200aplacebo (placebo group) and donepezil\u200a+\u200ateprenone (teprenone group']","['changes in scores of the Japanese version of the AD Assessment Scale-cognitive subscale (ADAS-J cog) and other evaluations, respectively, including MMSE scores', 'ADAS-J cog score changes', 'Adverse events', 'severity of medial temporal area atrophy', 'MMSE scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061231', 'cui_str': 'teprenone'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}]",79.0,0.658891,"ADAS-J cog score changes were not different between groups (placebo, 0.6±0.8; teprenone, 0.4±0.8; p = 0.861).","[{'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Yokoyama', 'Affiliation': 'Division of Neurosurgery, Nanpuh Hospital, Kagoshima, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Yoshinaga', 'Affiliation': 'Division of Clinical Application, Nanpuh Hospital, Kagoshima, Japan.'}, {'ForeName': 'Juntaro', 'Initials': 'J', 'LastName': 'Matsuzaki', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokai University School of Medicine, Isehara, Kanagawa, Japan.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190305']
745,31498125,"Differential Effects of Physical Exercise, Cognitive Training, and Mindfulness Practice on Serum BDNF Levels in Healthy Older Adults: A Randomized Controlled Intervention Study.","Previous studies have indicated that an active lifestyle is associated with better brain health and a longer life, compared to a more sedentary lifestyle. These studies, both on human and animal subjects, have typically focused on a single activity, usually physical exercise, but other activities have received an increasing interest. One proposed mechanism is that physical exercise increases levels of brain-derived neurotrophic factor (BDNF) in the brain. For the first time, the long-term effects on serum BDNF levels were compared in persons who engaged in either physical exercise training, cognitive training, or mindfulness practice during 5 weeks, and compared with an active control group. Two cohorts of healthy older individuals, one from the Boston area in the US and one from the Växjö area in Sweden, participated. A total of 146 participants were randomly assigned to one of the four groups. All interventions were structurally similar, using interactive, computer-based software that directed participants to carry out specified activities for 35 minutes/day, 5 days per week for 5 weeks. Blood samples were obtained at baseline and soon after the completion of the 5-week long intervention program, and serum BDNF levels were measured using a commercially available ELISA. Only the group that underwent cognitive training increased their serum BDNF levels after 5 weeks of training (F1,74 = 4.22, p = 0.044, partial η2 = 0.054), corresponding to an average 10% increase. These results strongly suggest that cognitive training can exert beneficial effects on brain health in an older adult population.",2019,"Only the group that underwent cognitive training increased their serum BDNF levels after 5 weeks of training (F1,74 = 4.22, p = 0.044, partial η2 = 0.054), corresponding to an average 10% increase.","['Healthy Older Adults', 'healthy older individuals, one from the Boston area in the US and one from the Växjö area in Sweden, participated', 'older adult population', 'A total of 146 participants']","['cognitive training', 'Physical Exercise, Cognitive Training, and Mindfulness Practice', 'physical exercise training, cognitive training']","['Serum BDNF Levels', 'serum BDNF levels', 'Blood samples', 'brain health']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",146.0,0.0188457,"Only the group that underwent cognitive training increased their serum BDNF levels after 5 weeks of training (F1,74 = 4.22, p = 0.044, partial η2 = 0.054), corresponding to an average 10% increase.","[{'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Ledreux', 'Affiliation': 'Knoebel Institute for Healthy Aging, University of Denver, Denver, CO, USA.'}, {'ForeName': 'Krister', 'Initials': 'K', 'LastName': 'Håkansson', 'Affiliation': 'Theme Aging, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Carlsson', 'Affiliation': 'Department of Psychology, Linnaeus University, Växjö, Sweden.'}, {'ForeName': 'Mhretab', 'Initials': 'M', 'LastName': 'Kidane', 'Affiliation': 'Department of Computer Science and Media Technology, Linnaeus University, Växjö, Sweden.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Columbo', 'Affiliation': 'Department of Neurosciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Terjestam', 'Affiliation': 'Department of Psychology, Linnaeus University, Växjö, Sweden.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Ryan', 'Affiliation': ""Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Tusch', 'Affiliation': ""Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Winblad', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'Daffner', 'Affiliation': ""Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ann-Charlotte', 'Initials': 'AC', 'LastName': 'Granholm', 'Affiliation': 'Knoebel Institute for Healthy Aging, University of Denver, Denver, CO, USA.'}, {'ForeName': 'Abdul Kadir H', 'Initials': 'AKH', 'LastName': 'Mohammed', 'Affiliation': 'Department of Psychology, Linnaeus University, Växjö, Sweden.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190756']
746,29721606,The effects of different durations of static stretching within a comprehensive warm-up on voluntary and evoked contractile properties.,"Evidence for performance decrements following prolonged static stretching (SS) has led to a paradigm shift in stretching routines within a warm-up. Rather than SS, dynamic stretching (DS) and dynamic activity (DA) have replaced SS within warm-up routines. The objective of the present study was to compare the effect of differing lower limb SS durations (30 [SS30s], 60 [SS60s] or 120 s [SS120s] of SS per muscle group or no-stretch control) within a comprehensive warm-up protocol consisting of aerobic activity, DS and DA. Sixteen male participants completed the four stretching conditions in a randomized order, after a 5-min low-intensity (cycle) warm-up and before a DS/DA component on separate days. Tests included passive hip and knee ranges of motion (ROM), maximum voluntary knee extensor/flexor force, force produced at 100 ms (F100), vertical jump height and evoked knee extensor contractile properties. For hip flexion (hamstrings) ROM, SS120s provided the largest increase (5.6-11.7%) followed by SS60s (4.3-11.4%), control (4.4-10.6%) and SS30s (3.6-11.1%). For knee flexion (quadriceps) ROM, SS30s provided the largest increase (9.3-18.2%) followed by SS120s (6.5-16.3%), SS60s (7.2-15.2%) and control (6.3-15.2%). There were decreases in quadriceps F100 following SS in SS120s (29.6%) only. There were increases in vertical jump performance in the control (6.2%), SS60s (4.6%) and SS30s (3.3%). While 120 s SS per muscle increased ROM, even within a comprehensive warm-up routine, it also elicited notable performance decrements. However, moderate durations of SS were observed to improve ROM whilst either having negligible or beneficial (but not detrimental) effects on specific aspects of athletic performance.",2018,"There were increases in vertical jump performance in the control (6.2%), SS60s (4.6%) and SS30s (3.3%).",['Sixteen male participants'],"['lower limb SS durations (30 [SS30s], 60 [SS60s] or 120\xa0s [SS120s] of SS per muscle group or no-stretch control) within a comprehensive warm-up protocol consisting of aerobic activity, DS and DA', 'prolonged static stretching (SS', 'static stretching', 'SS, dynamic stretching (DS) and dynamic activity (DA', 'hip flexion']","['SS60s', 'vertical jump performance', 'passive hip and knee ranges of motion (ROM), maximum voluntary knee extensor/flexor force, force produced at 100\xa0ms (F100), vertical jump height and evoked knee extensor contractile properties', 'moderate durations of SS', 'quadriceps F100']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C1720869', 'cui_str': 'Dynamic Stretching'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0576094', 'cui_str': 'Knee range of motion'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0060601', 'cui_str': 'FM100'}]",16.0,0.0184784,"There were increases in vertical jump performance in the control (6.2%), SS60s (4.6%) and SS30s (3.3%).","[{'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Reid', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, NF, A1M 3L8, Canada.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Greene', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, NF, A1M 3L8, Canada.""}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Young', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, NF, A1M 3L8, Canada.""}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Hodgson', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, NF, A1M 3L8, Canada.""}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Blazevich', 'Affiliation': 'Centre for Exercise and Sports Science Research, Edith Cowan University, Joondalup Campus, 270 Joondalup Drive, Joondalup, WA, Australia.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Behm', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, NF, A1M 3L8, Canada. dbehm@mun.ca.""}]",European journal of applied physiology,['10.1007/s00421-018-3874-3']
747,29725755,"Moderately heavy exercise produces lower cardiovascular, RPE, and discomfort compared to lower load exercise with and without blood flow restriction.","PURPOSE
To determine the acute cardiovascular and perceptual responses of low-load exercise with or without blood flow restriction and compare those responses to that of moderately heavy exercise.
METHODS
Twenty-two participants completed unilateral elbow flexion exercise with a moderately heavy-load- [70% one-repetition maximum (1RM); 70/0] and with three low-load conditions (15% 1RM) in combination with 0% (15/0), 40%, (15/40) and 80% (15/80) arterial occlusion pressure. Participants exercised until failure (or until 90 repetitions per set). The cardiovascular response (arterial occlusion) was measured pre and post exercise and the perceptual responses [ratings of perceived exertion (RPE) and discomfort] were determined before and after each set of exercise.
RESULTS
For arterial occlusion pressure, the lower-load conditions had greater change from pre to post compared to 70/00 (e.g., 15/80: 44 vs. 70/0: 34 mmHg). RPE was highest across the sets for the 15/80 condition with the other conditions having similar RPE (e.g., set 4: median rating of 17.2 for 15/80 vs. ~ 15.5 for other conditions). Ratings of discomfort were also greatest for the 15/80 condition (15/80 > 15/40 > 15/0 > 70/0). Exercise volume within the 15/0 and 15/40 conditions were similar but were significantly greater than that observed with the 15/80 and 70/0 conditions.
CONCLUSION
Low-load exercise to volitional failure results in a greater cardiovascular response to that of moderately heavy-load exercise. When high pressure is applied to low load exercise, there is a reduction in exercise volume but an elevated perceptual response that may be an important consideration when applying this stimulus in practice.",2018,"The cardiovascular response (arterial occlusion) was measured pre and post exercise and the perceptual responses [ratings of perceived exertion (RPE) and discomfort] were determined before and after each set of exercise.
","['Twenty-two participants completed', 'with a moderately heavy-load- [70% one-repetition maximum (1RM); 70/0] and with three low-load conditions (15% 1RM) in combination with 0% (15/0), 40%, (15/40) and 80% (15/80) arterial occlusion pressure']","['Low-load exercise', 'Moderately heavy exercise', 'low-load exercise with or without blood flow restriction', 'moderately heavy exercise', 'unilateral elbow flexion exercise']","['cardiovascular response (arterial occlusion', 'perceptual responses [ratings of perceived exertion (RPE) and discomfort', 'Exercise volume', 'Ratings of discomfort', 'cardiovascular, RPE, and discomfort', 'RPE']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery (disorder)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}]","[{'cui': 'C0264995', 'cui_str': 'Occlusion of artery (disorder)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}]",22.0,0.145183,"The cardiovascular response (arterial occlusion) was measured pre and post exercise and the perceptual responses [ratings of perceived exertion (RPE) and discomfort] were determined before and after each set of exercise.
","[{'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Bell', 'Affiliation': 'Department of Health, Exercise Science, and Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, P.O. Box 1848, University, MS, 38677, USA.'}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Buckner', 'Affiliation': 'Department of Health, Exercise Science, and Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, P.O. Box 1848, University, MS, 38677, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Jessee', 'Affiliation': 'Department of Health, Exercise Science, and Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, P.O. Box 1848, University, MS, 38677, USA.'}, {'ForeName': 'J Grant', 'Initials': 'JG', 'LastName': 'Mouser', 'Affiliation': 'Department of Health, Exercise Science, and Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, P.O. Box 1848, University, MS, 38677, USA.'}, {'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'Mattocks', 'Affiliation': 'Department of Health, Exercise Science, and Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, P.O. Box 1848, University, MS, 38677, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Dankel', 'Affiliation': 'Department of Health, Exercise Science, and Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, P.O. Box 1848, University, MS, 38677, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Health, Exercise Science, and Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, P.O. Box 1848, University, MS, 38677, USA.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Loenneke', 'Affiliation': 'Department of Health, Exercise Science, and Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, P.O. Box 1848, University, MS, 38677, USA. jploenne@olemiss.edu.'}]",European journal of applied physiology,['10.1007/s00421-018-3877-0']
748,29284111,Digoxin Benefit Varies by Risk of Heart Failure Hospitalization: Applying the Tufts MC HF Risk Model.,"BACKGROUND
Digoxin has been shown to reduce heart failure hospitalizations with a neutral effect on mortality. It is unknown whether there is heterogeneity of treatment effect for digitalis therapy according to predicted risk of heart failure hospitalization.
METHODS AND RESULTS
We conducted a post hoc analysis of the Digitalis Investigator Group (DIG) studies, randomized controlled trials of digoxin vs placebo in participants with heart failure and left ventricular ejection fraction ≤45% (main DIG study, n = 6800) or >45% (ancillary DIG study, n = 988). Using a previously derived multistate model to risk-stratify DIG study participants, we determined the differential treatment effect on hospitalization and mortality outcomes. There was a 13% absolute reduction in the risk of any heart failure hospitalizations (39% vs 52%; odds ratio 0.58; 95% confidence interval 0.47-0.71) in the digoxin vs placebo arms in the highest-risk quartile, compared with a 3% absolute risk reduction for any heart failure hospitalization (17% vs 20%; odds ratio 0.84; 95% confidence interval, 0.66-1.08) in the lowest-risk quartile. There were 12 fewer total all-cause hospitalizations per 100 person-years in the highest-risk quartile compared with an increase of 8 hospitalizations per 100 person-years in the lowest-risk quartile. There was neutral effect of digoxin on mortality in all risk quartiles and no interaction between baseline risk and the effect of digoxin on mortality (P = .94).
CONCLUSIONS
Participants in the DIG study at higher risk of hospitalization as identified by a multistate model were considerably more likely to benefit from digoxin therapy to reduce heart failure hospitalization.",2018,"There was neutral effect of digoxin on mortality in all risk quartiles and no interaction between baseline risk and the effect of digoxin on mortality (P = .94).
","['participants with heart failure and left ventricular ejection fraction ≤45% (main DIG study, n\xa0']","['placebo', 'Digoxin', 'digoxin vs placebo', 'digoxin', 'digoxin therapy']","['hospitalization and mortality outcomes', 'heart failure hospitalization', 'risk of any heart failure hospitalizations']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C3181833', 'cui_str': 'Dig(dhd)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.273566,"There was neutral effect of digoxin on mortality in all risk quartiles and no interaction between baseline risk and the effect of digoxin on mortality (P = .94).
","[{'ForeName': 'Jenica N', 'Initials': 'JN', 'LastName': 'Upshaw', 'Affiliation': 'The CardioVascular Center, Tufts Medical Center, Boston, Mass. Electronic address: jupshaw@tuftsmedicalcenter.org.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'van Klaveren', 'Affiliation': 'The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Mass; The Medical Statistics Department, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Marvin A', 'Initials': 'MA', 'LastName': 'Konstam', 'Affiliation': 'The CardioVascular Center, Tufts Medical Center, Boston, Mass.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kent', 'Affiliation': 'The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Mass.'}]",The American journal of medicine,['10.1016/j.amjmed.2017.12.010']
749,31876673,Heavy Resistance Training in Breast Cancer Patients Undergoing Adjuvant Therapy.,"BACKGROUND AND PURPOSE
Adjuvant breast cancer therapy may reduce maximal muscle strength, muscle mass, and functional performance. Although maximal strength training (MST) has the potential to counteract this debilitating outcome and is shown to be superior to low- and moderate-intensity strength training, it is unknown if it can elicit effective adaptations in patients suffering treatment-induced adverse side effects.
METHODS
Fifty-five newly diagnosed stage I to III breast cancer patients (49 ± 7 yr) scheduled for adjuvant therapy were randomized to MST or a control group. The MST group performed 4 × 4 repetitions of dynamic leg press at approximately 90% of one-repetition maximum (1RM) twice a week for 12 wk.
RESULTS
In the MST group, improvements in 1RM (20% ± 8%; P < 0.001) were accompanied by improved walking economy (9% ± 8%) and increased time to exhaustion during incremental walking (9% ± 8%; both P < 0.01). Moreover, the MST group increased 6-min walking distance (6MWD; 10% ± 7%), and chair rising (30% ± 20%) and stair climbing performance (12% ± 7%; all P < 0.001). All MST-induced improvements were different from the control group (P < 0.01) which reduced their 1RM (9% ± 5%), walking economy (4% ± 4%), time to exhaustion (10% ± 8%), 6MWD (5% ± 5%), chair rising performance (12% ± 12%), and stair climbing performance (6% ± 8%; all P < 0.01). Finally, although MST maintained estimated quadriceps femoris muscle mass, a decrease was observed in the control group (7% ± 10%; P < 0.001). The change in 1RM correlated with the change in walking economy (r = 0.754), time to exhaustion (r = 0.793), 6MWD (r = 0.807), chair rising performance (r = 0.808), and stair climbing performance (r = 0.754; all P < 0.001).
CONCLUSIONS
Lower-extremity MST effectively increases lower-extremity maximal muscle strength in breast cancer patients undergoing adjuvant therapy and results in improved work economy, functional performance, and maintenance of muscle mass. These results advocate that MST should be considered in breast cancer treatment.",2020,"Lower extremity MST effectively increases lower extremity maximal muscle strength in breast cancer patients undergoing adjuvant therapy and results in improved work economy, functional performance, and maintenance of muscle mass.","['Fifty-five newly diagnosed stage', 'Breast Cancer Patients Undergoing Adjuvant Therapy', 'breast cancer patients undergoing', 'patients suffering treatment-induced adverse side effects', 'I-III breast cancer patients (49±7 years) scheduled for adjuvant therapy']","['adjuvant therapy', 'MST', 'maximal strength training (MST', 'Heavy Resistance Training']","['1RM', '6 minutes walking distance (6MWD; 10±7%), and chair rising', 'work economy, functional performance, and maintenance of muscle mass', 'quadriceps femoris muscle mass', 'change in 1RM', 'time to exhaustion', 'maximal muscle strength, muscle mass, and functional performance', 'time to exhaustion (10±8%), 6MWD (5±5%), chair rising performance', 'walking economy', 'stair climbing performance', 'time to exhaustion (r=0.793), 6MWD (r=0.807), chair rising performance (r=0.808), and stair climbing performance', 'extremity maximal muscle strength']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C3853978'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1290942', 'cui_str': 'Stair Navigation'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}]",55.0,0.0130742,"Lower extremity MST effectively increases lower extremity maximal muscle strength in breast cancer patients undergoing adjuvant therapy and results in improved work economy, functional performance, and maintenance of muscle mass.","[{'ForeName': 'Rūdolfs', 'Initials': 'R', 'LastName': 'Cešeiko', 'Affiliation': 'Department of Rehabilitation, Rīga Stradiņš University, Rīga, LATVIA.'}, {'ForeName': 'Simon Nørskov', 'Initials': 'SN', 'LastName': 'Thomsen', 'Affiliation': 'Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, DENMARK.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Tomsone', 'Affiliation': 'Department of Rehabilitation, Rīga Stradiņš University, Rīga, LATVIA.'}, {'ForeName': 'Jānis', 'Initials': 'J', 'LastName': 'Eglītis', 'Affiliation': 'The Oncology Centre of Latvia, Rīga, LATVIA.'}, {'ForeName': 'Aivars', 'Initials': 'A', 'LastName': 'Vētra', 'Affiliation': 'Department of Rehabilitation, Rīga Stradiņš University, Rīga, LATVIA.'}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Srebnijs', 'Affiliation': 'Faculty of Medicine, University of Latvia, Rīga, LATVIA.'}, {'ForeName': 'Mihails', 'Initials': 'M', 'LastName': 'Timofejevs', 'Affiliation': 'The Oncology Centre of Latvia, Rīga, LATVIA.'}, {'ForeName': 'Egīls', 'Initials': 'E', 'LastName': 'Purmalis', 'Affiliation': 'The Oncology Centre of Latvia, Rīga, LATVIA.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Rīga Stradiņš University, Rīga, LATVIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002260']
750,31501226,"Heart Rate Variability and Cardiac Autonomic Dysfunction: Prevalence, Risk Factors, and Relationship to Arterial Stiffness in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study.","OBJECTIVE
To determine whether prior type 2 diabetes (T2D) treatment or glycemic control over time are independently associated with heart rate variability (HRV) and whether the presence of cardiac autonomic dysfunction is associated with arterial stiffness in young adults with youth-onset T2D enrolled in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study.
RESEARCH DESIGN AND METHODS
Heartbeats over 10 min were measured to derive the normal R-Rs (NN intervals). Outcomes included the standard deviation of the NN intervals (SDNN), the root mean square differences of successive NN intervals (RMSSD), percent of NN beats that differ by more than 50 ms (PNN50), and the low-frequency (LF) power domain, high-frequency (HF) power domain, and their ratio (LF:HF). Autonomic dysfunction was defined as ≥3 of 5 abnormal HRV indices compared with obese controls from a separate study.
RESULTS
A total of 397 TODAY participants were evaluated 7 years after randomization. TODAY participants had reduced HRV (SDNN 58.1 ± 29.6 ms vs. controls 67.1 ± 25.4 ms; P < 0.0001) with parasympathetic loss (RMSSD 53.2 ± 36.7 ms vs. controls 67.9 ± 35.2 ms; P < 0.0001) with sympathetic overdrive (LF:HF ratio 1.4 ± 1.7 vs. controls 1.0 ± 1.1; P < 0.0001). Cardiac autonomic dysfunction was present in 8% of TODAY participants, and these participants had greater pulse wave velocity compared with those without dysfunction ( P = 0.0001). HRV did not differ by randomized treatment, but higher hemoglobin A1c (HbA 1c ) over time was independently associated with lower SDNN and RMSSD and higher LF:HF ratio after adjustment for age, race-ethnicity, sex, and BMI.
CONCLUSIONS
Young adults with youth-onset T2D show evidence of cardiac autonomic dysfunction with both parasympathetic and sympathetic impairments that are associated with higher HbA 1c .",2019,TODAY participants had reduced HRV (SDNN; 57.9 ± 29.6 ms vs. controls 67.1 ± 25.4 ms; P < 0.0001) with parasympathetic loss (RMSSD; 53.0 ± 36.6 ms vs. controls 67.9 ± 35.2 ms; P < 0.0001) with sympathetic overdrive (LF:HF ratio; 1.4 ± 1.7 vs. controls 1.0 ± 1.1; P < 0.0001).,"['A total of 397 TODAY participants were evaluated 7 years after randomization', 'Young adults with youth-onset T2D', 'young adults with youth-onset T2D enrolled in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study']","['LF', 'prior type 2 diabetes (T2D) treatment or glycemic control']","['HF ratio', 'Autonomic dysfunction', 'heart rate variability (HRV', 'parasympathetic loss', 'HRV', 'standard deviation of the NN intervals (SDNN), the root mean square differences of successive NN intervals (RMSSD), percent of NN beats that differ by more than 50 ms (PNN50), and the low-frequency (LF) power domain, high-frequency (HF) power domain, and their ratio (LF:HF', 'Heart Rate Variability and Cardiac Autonomic Dysfunction', 'Cardiac autonomic dysfunction', 'hemoglobin A1c (HbA 1c ) over time']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1145628', 'cui_str': 'Central Autonomic Nervous System Diseases'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",397.0,0.0563142,TODAY participants had reduced HRV (SDNN; 57.9 ± 29.6 ms vs. controls 67.1 ± 25.4 ms; P < 0.0001) with parasympathetic loss (RMSSD; 53.0 ± 36.6 ms vs. controls 67.9 ± 35.2 ms; P < 0.0001) with sympathetic overdrive (LF:HF ratio; 1.4 ± 1.7 vs. controls 1.0 ± 1.1; P < 0.0001).,"[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'El Ghormli', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, MD elghorml@bsc.gwu.edu.'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Vajravelu', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Fida', 'Initials': 'F', 'LastName': 'Bacha', 'Affiliation': ""Texas Children's Hospital, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Farrell', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Gidding', 'Affiliation': 'FH Foundation, Pasadena, CA.'}, {'ForeName': 'Lorraine E', 'Initials': 'LE', 'LastName': 'Levitt Katz', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Jeanie B', 'Initials': 'JB', 'LastName': 'Tryggestad', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Neil H', 'Initials': 'NH', 'LastName': 'White', 'Affiliation': 'Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Urbina', 'Affiliation': ""Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH.""}]",Diabetes care,['10.2337/dc19-0993']
751,29509592,Impact of Trabectedin Interruption and Subsequent Rechallenge on Progression in Patients With Advanced Soft Tissue Sarcoma: Long-term Follow-up of the T-DIS trial.,"OBJECTIVE
To assess the impact of trabectedin rechallenge.
PATIENTS AND METHODS
In the T-DIS trial (NCT0130309), after the 6 initial cycles of trabectedin, patients who were free from progressive disease (PD) were randomly assigned either to continuous treatment with trabectedin (C arm) or therapy interruption (I arm). Patients randomized in the interruption arm were allowed to restart trabectedin in case of PD. Herein we report an update of the impact of trabectedin discontinuation after subsequent rechallenge.
RESULTS
From February 2011 to March 2013, 27 and 26 nonprogressive patients were randomized to C and I arm, respectively. Twenty-two of 26 patients in I arm and 25 of 27 patients in C arm received 7 cycles and more. After randomization, the median number of cycles was similar in both arms (C arm: 5 cycles [range, 1 to 34]; I arm: 6 cycles [range, 1 to 48], P=0.96). After a median follow-up from randomization of 35.3 months, continuous treatment with trabectedin was associated with a significant improvement in progression-free survival compared with the rechallenge arm (5.3 vs. 3.5 mo, P=0.019). The observed difference in median overall survival from the seventh cycle did not meet the level of significance (26.0 vs. 14.9 mo, P=0.14). The safety profile was similar in both arms. Mean time spent without symptoms and toxicity (Q-TWIST) was higher in the C arm, but the difference did not reach the level of significance.
CONCLUSIONS
We have demonstrated that trabectedin retains its activity when patients are rechallenged on progression after a treatment break.",2018,"Mean time spent without symptoms and toxicity (Q-TWIST) was higher in the C arm, but the difference did not reach the level of significance.
","['27 and 26 nonprogressive patients', 'Patients With Advanced Soft Tissue Sarcoma', 'patients who were free from progressive disease (PD']","['continuous treatment with trabectedin (C arm) or therapy interruption', 'Trabectedin Interruption and Subsequent Rechallenge']","['Mean time spent without symptoms and toxicity (Q-TWIST', 'median number of cycles', 'progression-free survival', 'safety profile', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0040480', 'cui_str': 'Musculoskeletal torsion (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.255558,"Mean time spent without symptoms and toxicity (Q-TWIST) was higher in the C arm, but the difference did not reach the level of significance.
","[{'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Kotecki', 'Affiliation': '*Medical Oncology Department ‡Methodology and Biostatistics Unit #Clinical Research Unit, Centre Oscar Lambret ∥Medical Oncology, Institut Claudius Regaud, Cedex †Medical Oncology Department, Villejuif §Medical Oncology Department, Centre Léon Bérard, Lyon ¶Medical Oncology Department, Institut Paoli Calmette, Marseille, France.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Le Cesne', 'Affiliation': ''}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Tresch-Bruneel', 'Affiliation': ''}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Chevreau', 'Affiliation': ''}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Bertucci', 'Affiliation': ''}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Bogart', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Mir', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pautier', 'Affiliation': ''}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Decoupigny', 'Affiliation': ''}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Clisant', 'Affiliation': ''}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Penel', 'Affiliation': ''}]",American journal of clinical oncology,['10.1097/COC.0000000000000430']
752,31915906,β 2 adrenergic interaction and cardiac autonomic function: effects of aerobic training in overweight/obese individuals.,"PURPOSE
To verify the influence of different volumes and intensities of aerobic exercise on cardiac autonomic function (CAF) through heart rate variability (HRV) analysis as well the influence of β2 adrenergic receptor (ADRB2) variants in overweight/obese individuals.
METHODS
70 physically inactive adults were randomly allocated into the following 16-week training: 1-high-intensity interval training (HIIT) (n = 25, 1 × 4 min bout at 85-95%HR peak, 3×/week), 4-HIIT (n = 26, 4 × 4 min bouts at 85-95%HR peak, interspersed with 3 min of recovery at 50-70%HR peak, 3×/week), and moderate continuous training (MCT) (n = 19, 30 min at 60-70%HR peak, 5×/week). Before and after the exercise training, anthropometric, BP, cardiorespiratory fitness, and HRV measures were evaluated. R-R intervals recorded for 10 min in a supine position at pre- and post-intervention were used to analyze HRV in the plot-Poincare indexes (SD1, SD2), and frequency-domain (LF, HF, LF/HF). Full blood samples were used for genotyping.
RESULTS
4-HIIT and MCT showed positive outcomes for almost all variables while 1-HIIT had a positive influence only on SBP and SD2 index. No associations were observed between isolated ADRB2 variants and changes in HRV. In the analysis of the interaction genotypes, all groups responded positively for the SD1 index of HRV and only the H1 (GG and CC) and H2 (GG and CG + GG) groups presented increases in the RMSSD index. Furthermore, there was an increase in the LF index only in the H3 (CC and AA + AG) and H4 (AA + AG and CG + GG) groups.
CONCLUSIONS
ADRB2 variants and aerobic exercise training are important interacting variables to improve autonomic function and other health variables outcomes in overweight or obese individuals.",2020,"RESULTS
4-HIIT and MCT showed positive outcomes for almost all variables while 1-HIIT had a positive influence only on SBP and SD2 index.","['overweight/obese individuals', 'overweight or obese individuals', '70 physically inactive adults']","['training: 1-high-intensity interval training (HIIT) (n\u2009=\u200925, 1\u2009×\u20094\xa0min bout at 85-95%HR peak, 3×/week), 4-HIIT (n\u2009=\u200926, 4', 'aerobic exercise', 'aerobic training', 'aerobic exercise training', 'moderate continuous training (MCT']","['SBP and SD2 index', 'cardiac autonomic function (CAF', 'anthropometric, BP, cardiorespiratory fitness, and HRV measures', 'SD1 index of HRV', 'HRV', 'RMSSD index', 'LF index']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1861380', 'cui_str': 'Syndactyly, Type I'}]",70.0,0.0413567,"RESULTS
4-HIIT and MCT showed positive outcomes for almost all variables while 1-HIIT had a positive influence only on SBP and SD2 index.","[{'ForeName': 'Jhennyfer Aline Lima', 'Initials': 'JAL', 'LastName': 'Rodrigues', 'Affiliation': 'School of Nursing of Ribeirão Preto, University of São Paulo (USP), Bandeirantes Avenue 3900, Ribeirão Preto, SP, 14040-907, Brazil. jhennyrodrigues@usp.br.'}, {'ForeName': 'Gustavo Duarte', 'Initials': 'GD', 'LastName': 'Ferrari', 'Affiliation': 'Department of Physics and Chemistry, Faculty of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo (USP), Bandeirantes Avenue 3900, Ribeirão Preto, SP, 14040-903, Brazil.'}, {'ForeName': 'Átila Alexandre', 'Initials': 'ÁA', 'LastName': 'Trapé', 'Affiliation': 'School of Nursing of Ribeirão Preto, University of São Paulo (USP), Bandeirantes Avenue 3900, Ribeirão Preto, SP, 14040-907, Brazil.'}, {'ForeName': 'Vitor Nolasco', 'Initials': 'VN', 'LastName': 'de Moraes', 'Affiliation': 'Ribeirão Preto Medical School, Department of Medical Clinic, University of São Paulo (USP), Bandeirantes Avenue 3900, Ribeirão Preto, SP, 14040-907, Brazil.'}, {'ForeName': 'Thiago Correa Porto', 'Initials': 'TCP', 'LastName': 'Gonçalves', 'Affiliation': 'Ribeirão Preto Medical School, Department of Medical Clinic, University of São Paulo (USP), Bandeirantes Avenue 3900, Ribeirão Preto, SP, 14040-907, Brazil.'}, {'ForeName': 'Simone Sakagute', 'Initials': 'SS', 'LastName': 'Tavares', 'Affiliation': 'Department of Physics and Chemistry, Faculty of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo (USP), Bandeirantes Avenue 3900, Ribeirão Preto, SP, 14040-903, Brazil.'}, {'ForeName': 'Arnt Erik', 'Initials': 'AE', 'LastName': 'Tjønna', 'Affiliation': 'K.G. Jebsen Center of Exercise in Medicine at Department of Circulation and Medical Imaging, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Hugo Celso Dutra', 'Initials': 'HCD', 'LastName': 'de Souza', 'Affiliation': 'Ribeirão Preto Medical School, Exercise Physiology Laboratory, Department of Health Science, University of São Paulo (USP), Bandeirantes Avenue, 3900Vila Monte Alegre, Ribeirão Preto, SP, 14049-900, Brazil.'}, {'ForeName': 'Carlos Roberto Bueno', 'Initials': 'CRB', 'LastName': 'Júnior', 'Affiliation': 'School of Nursing of Ribeirão Preto, University of São Paulo (USP), Bandeirantes Avenue 3900, Ribeirão Preto, SP, 14040-907, Brazil.'}]",European journal of applied physiology,['10.1007/s00421-020-04301-z']
753,30096441,An Automated Intervention Did Not Improve Adherence to Oral Oncolytic Agents While Managing Symptoms: Results From a Two-Arm Randomized Controlled Trial.,"CONTEXT
An increasing number of oral cancer treatments require patient adherence and symptom self-management.
OBJECTIVES
The report presents the effects of a medication reminder and symptom management intervention directed at patients initiating new oral oncolytic agents.
METHODS
Patients (N = 272) were recruited at six comprehensive cancer centers, interviewed over the telephone after oral agent initiation, and randomized to either standard care or a medication reminder and symptom management intervention. In the intervention arm, the automated system called patients daily to remind them about taking their medications and weekly to assess 18 symptoms and refer patients to a printed Medication Management and Symptom Management Toolkit. Severity of 18 symptoms was also assessed during telephone interviews at Week 4 (midintervention), Week 8 (postintervention), and Week 12 (follow-up). Adherence was measured using the relative dose intensity, the ratio of dose taken by patient out of dose prescribed by the oncologist, and assessed using pill counts at Weeks 4, 8, and 12 and prescribing information from medical records.
RESULTS
The relative dose intensity was high and did not differ by trial arm. Symptom severity was significantly lower (P < 0.01) in the experimental arm at Week 8 but not at Weeks 4 or 12.
CONCLUSION
Adherence may be less of a problem than originally anticipated, and intervention was not efficacious possibly because of already high rates of patient adherence to oral oncolytic medication during first 12 weeks. Longer follow-up in future research may identify subgroups of patients who need interventions to sustain adherence.",2018,"Symptom severity was significantly lower (P < 0.01) in the experimental arm at Week 8 but not at Weeks 4 or 12.
","['Patients (N\xa0=\xa0272) were recruited at six comprehensive cancer centers, interviewed over the']","['telephone after oral agent initiation, and randomized to either standard care or a medication reminder and symptom management intervention', 'automated system called patients daily to remind them about taking their medications and weekly to assess 18 symptoms and refer patients to a printed Medication Management and Symptom Management Toolkit']","['Symptom severity', 'Adherence', 'Adherence to Oral Oncolytic Agents']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0557033', 'cui_str': 'Reminding (procedure)'}, {'cui': 'C1290952', 'cui_str': 'Taking medication (observable entity)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]",272.0,0.0555065,"Symptom severity was significantly lower (P < 0.01) in the experimental arm at Week 8 but not at Weeks 4 or 12.
","[{'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Sikorskii', 'Affiliation': 'Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Given', 'Affiliation': 'Michigan State University, East Lansing, Michigan, USA. Electronic address: givenc@msu.edu.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Given', 'Affiliation': 'Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vachon', 'Affiliation': 'Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Krauss', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rosenzweig', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McCorkle', 'Affiliation': 'Yale University, Orange, Connecticut, USA.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Champion', 'Affiliation': 'Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Asish', 'Initials': 'A', 'LastName': 'Banik', 'Affiliation': 'Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'Atreyee', 'Initials': 'A', 'LastName': 'Majumder', 'Affiliation': 'Michigan State University, East Lansing, Michigan, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2018.07.021']
754,31628698,"Efficacy and safety of cariprazine in bipolar I depression: A double-blind, placebo-controlled phase 3 study.","OBJECTIVE
To assess the efficacy, safety, and tolerability of cariprazine in the treatment of the depressed phase of bipolar I disorder in adults (NCT02670538).
METHODS
In this phase 3 double-blind placebo-controlled study, adult patients with bipolar I disorder according to the Diagnostic and Statistical Manual - 5th Edition criteria and a current depressive episode were randomized to placebo (n = 167), cariprazine 1.5 mg/day (n = 168) or cariprazine 3.0 mg/day (n = 158). Efficacy parameters were changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) total scores (primary) and Clinical Global Impressions - Severity (CGI-S) scores (secondary) from baseline to Week 6 compared to placebo. A mixed-model for repeated measures was used to estimate the least-squares mean differences (LSMD); P-values were adjusted for multiplicity. Adverse events (AEs), laboratory results, vital signs, and suicide risk were monitored.
RESULTS
Cariprazine 1.5 mg/day significantly reduced depressive symptoms on the primary (MADRS LSMD = -2.5; adjusted P = .0417) and secondary (CGI-S LSMD = -0.3; adjusted P = .0417) efficacy parameters vs placebo; differences were not statistically significant for cariprazine 3.0 mg/day. Common treatment-emergent AEs (≥5% in either cariprazine group and at least twice the incidence of placebo) were akathisia, restlessness, nausea, and fatigue. Mean metabolic parameter changes were low and generally comparable among groups; mean weight increases were ≤0.5 kg for all groups.
CONCLUSIONS
Cariprazine 1.5 mg/day significantly reduced depressive symptoms in adults with bipolar I depression compared to placebo, but differences were not significant for cariprazine 3.0 mg/day. The safety and tolerability profiles were similar to previous studies of cariprazine.",2020,"Mean metabolic parameter changes were low and generally comparable among groups; mean weight increases were ≤0.5 kg for all groups.
","['adult patients with bipolar I disorder according to the Diagnostic and Statistical Manual - 5 th Edition criteria and a current depressive episode', 'bipolar I depression']","['placebo', 'cariprazine 1.5 mg/day[d', 'Cariprazine', 'cariprazine']","['depressive symptoms', 'safety and tolerability profiles', 'Mean metabolic parameter changes', 'akathisia, restlessness, nausea, and fatigue', 'mean weight increases', 'Montgomery-Åsberg Depression Rating Scale (MADRS) total scores (primary) and Clinical Global Impressions - Severity (CGI-S) scores', 'Adverse events (AEs), laboratory results, vital signs, and suicide risk', 'Efficacy and safety', 'efficacy, safety, and tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder (disorder)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4056789', 'cui_str': 'cariprazine 1.5 MG'}, {'cui': 'C2936870', 'cui_str': 'cariprazine'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0542200', 'cui_str': 'Restlessness (phenothiazine)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518766'}, {'cui': 'C0563664', 'cui_str': 'Suicide risk'}]",,0.20525,"Mean metabolic parameter changes were low and generally comparable among groups; mean weight increases were ≤0.5 kg for all groups.
","[{'ForeName': 'Willie R', 'Initials': 'WR', 'LastName': 'Earley', 'Affiliation': 'Department of Clinical Development, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Maria V', 'Initials': 'MV', 'LastName': 'Burgess', 'Affiliation': 'Department of Clinical Development, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Khan', 'Affiliation': 'Department of Clinical Development, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Ludmyla', 'Initials': 'L', 'LastName': 'Rekeda', 'Affiliation': 'Department of Biostatistics, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine and V.A. Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Tohen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychiatry, Case Western Reserve School of Medicine, Cleveland, OH, USA.'}]",Bipolar disorders,['10.1111/bdi.12852']
755,29484198,Physical therapy and deep brain stimulation in Parkinson's Disease: protocol for a pilot randomized controlled trial.,"Background
Subthalamic nucleus deep brain stimulation (STN-DBS) reduces tremor, muscle stiffness, and bradykinesia in people with Parkinson's Disease (PD). Walking speed, known to be reduced in PD, typically improves after surgery; however, other important aspects of gait may not improve. Furthermore, balance may worsen and falls may increase after STN-DBS. Thus, interventions to improve balance and gait could reduce morbidity and improve quality of life following STN-DBS. Physical therapy (PT) effectively improves balance and gait in people with PD, but studies on the effects of PT have not been extended to those treated with STN-DBS. As such, the efficacy, safety, and feasibility of PT in this population remain to be determined. The purpose of this pilot study is to address these unmet needs. We hypothesize that PT designed to target balance and gait impairment will be effective, safe, and feasible in this population.
Methods/design
Participants with PD treated with STN-DBS will be randomly assigned to either a PT or control group. Participants assigned to PT will complete an 8-week, twice-weekly PT program consisting of exercises designed to improve balance and gait. Control group participants will receive the current standard of care following STN-DBS, which does not include prescription of PT. The primary aim is to assess preliminary efficacy of PT on balance (Balance Evaluation Systems Test). A secondary aim is to assess efficacy of PT on gait (GAITRite instrumented walkway). Participants will be assessed OFF medication/OFF stimulation and ON medication/ON stimulation at baseline and at 8 and 12 weeks after baseline. Adverse events will be measured over the duration of the study, and adherence to PT will be measured to determine feasibility.
Discussion
To our knowledge, this will be the first study to explore the preliminary efficacy, safety, and feasibility of PT for individuals with PD with STN-DBS. If the study suggests potential efficacy, then this would justify larger trials to test effectiveness and safety of PT for those with PD with STN-DBS.
Trial registration
NCT03181282 (clinicaltrials.gov). Registered on 7 June 2017.",2018,"Background
Subthalamic nucleus deep brain stimulation (STN-DBS) reduces tremor, muscle stiffness, and bradykinesia in people with Parkinson's Disease (PD).","[""Parkinson's Disease"", 'individuals with PD with STN-DBS', 'people with PD', 'Participants with PD treated with STN-DBS', ""people with Parkinson's Disease (PD""]","['PT', 'Physical therapy (PT', 'Physical therapy and deep brain stimulation', '\n\n\nSubthalamic nucleus deep brain stimulation (STN-DBS']","['balance and gait', 'Adverse events', 'efficacy, safety, and feasibility of PT', 'OFF medication/OFF stimulation and ON medication/ON stimulation', 'quality of life']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}, {'cui': 'C0152355', 'cui_str': 'Nucleus Subthalamicus'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0034380'}]",,0.0750635,"Background
Subthalamic nucleus deep brain stimulation (STN-DBS) reduces tremor, muscle stiffness, and bradykinesia in people with Parkinson's Disease (PD).","[{'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Duncan', 'Affiliation': '1Program in Physical Therapy, Washington University School of Medicine in Saint Louis, Campus Box 8502, 4444 Forest Park Blvd, St. Louis, MO 63108 USA.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Van Dillen', 'Affiliation': '1Program in Physical Therapy, Washington University School of Medicine in Saint Louis, Campus Box 8502, 4444 Forest Park Blvd, St. Louis, MO 63108 USA.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Garbutt', 'Affiliation': '4Department of Medicine, Washington University School of Medicine in Saint Louis, St. Louis, MO USA.'}, {'ForeName': 'Gammon M', 'Initials': 'GM', 'LastName': 'Earhart', 'Affiliation': '1Program in Physical Therapy, Washington University School of Medicine in Saint Louis, Campus Box 8502, 4444 Forest Park Blvd, St. Louis, MO 63108 USA.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Perlmutter', 'Affiliation': '1Program in Physical Therapy, Washington University School of Medicine in Saint Louis, Campus Box 8502, 4444 Forest Park Blvd, St. Louis, MO 63108 USA.'}]",Pilot and feasibility studies,['10.1186/s40814-018-0243-2']
756,29406520,"Pre-treatment microbial Prevotella-to-Bacteroides ratio, determines body fat loss success during a 6-month randomized controlled diet intervention.",This corrects the article DOI: 10.1038/ijo.2017.220.,2018,This corrects the article DOI: 10.1038/ijo.2017.220.,[],['Pre-treatment microbial Prevotella-to-Bacteroides ratio'],[],[],"[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242946', 'cui_str': 'Prevotella'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",[],,0.0212005,This corrects the article DOI: 10.1038/ijo.2017.220.,"[{'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': ''}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Roager', 'Affiliation': ''}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Larsen', 'Affiliation': ''}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Poulsen', 'Affiliation': ''}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Licht', 'Affiliation': ''}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Bahl', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zohar', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': ''}]",International journal of obesity (2005),['10.1038/ijo.2018.1']
757,28742409,"The effects of vitamin D and evening primrose oil co-supplementation on lipid profiles and biomarkers of oxidative stress in vitamin D-deficient women with polycystic ovary syndrome: A randomized, double-blind, placebo-controlled trial.","PURPOSE OF THE STUDY
There was inconsistent evidence about the benefit of vitamin D plus evening primrose oil (EPO) supplement intake on lipid profiles and reduced oxidative stress among women with polycystic ovary syndrome (PCOS). The current study was performed to evaluate the effects of vitamin D plus EPO supplementation on lipid profiles and biomarkers of oxidative stress in vitamin D-deficient women with PCOS.
MATERIALS AND METHODS
This randomized, double-blind, placebo-controlled trial was performed among 60 vitamin D-deficient women with PCOS. Participants were randomly assigned into two groups to receive either 1000 IU vitamin D3 plus 1000 mg EPO (n = 30) or placebo (n = 30) for 12 weeks. Metabolic profiles were quantified at baseline and after the 12-week intervention.
RESULTS
Compared with the placebo group, women in vitamin D and EPO co-supplementation group had significant increases in serum 25-hydroxyvitamin D (25(OH)D) (+10.7 ± 8.4 vs. -0.5 ± 1.6 ng/mL, p < 0.001) and plasma total glutathione (GSH) (+62.7 ± 58.0 vs. -0.7 ± 122.7 µmol/L, p = 0.01), while there were significant decreases in triglycerides (-7.3 ± 23.8 vs. +6.9 ± 26.3 mg/dL, p = 0.03), very low-density lipoprotein (VLDL) cholesterol levels (-1.5 ± 4.7 vs. +1.4 ± 5.3 mg/dL, p = 0.03), total/high-density lipoprotein cholesterol ratio (-0.3 ± 0.4 vs. -0.02 ± 0.4, p = 0.02), and malondialdehyde (MDA) concentration (-0.4 ± 0.4 vs. +0.5 ± 1.8 µmol/L, p = 0.008).
CONCLUSION
Overall, vitamin D and EPO co-supplementation for 12 weeks among vitamin D-deficient women with PCOS significantly improved triglycerides, VLDL cholesterol, GSH, and MDA levels.",2018,There was inconsistent evidence about the benefit of vitamin D plus evening primrose oil (EPO) supplement intake on lipid profiles and reduced oxidative stress among women with polycystic ovary syndrome (PCOS).,"['vitamin D-deficient women with polycystic ovary syndrome', 'vitamin D-deficient women with PCOS', '60 vitamin D-deficient women with PCOS', 'women with polycystic ovary syndrome (PCOS']","['placebo', 'vitamin D and evening primrose oil co-supplementation', 'vitamin D plus evening primrose oil (EPO) supplement intake', 'vitamin D plus EPO supplementation', '1000 IU vitamin D3 plus 1000 mg EPO']","['triglycerides', 'serum 25-hydroxyvitamin D (25(OH)D', 'low-density lipoprotein (VLDL) cholesterol levels', 'malondialdehyde (MDA) concentration', 'Overall, vitamin D and EPO co-supplementation', 'triglycerides, VLDL cholesterol, GSH, and MDA levels', 'Metabolic profiles', 'lipid profiles and reduced oxidative stress', 'total/high-density lipoprotein cholesterol ratio', 'lipid profiles and biomarkers of oxidative stress', 'plasma total glutathione (GSH']","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0700602', 'cui_str': 'Oenothera biennis oil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}]",,0.759904,There was inconsistent evidence about the benefit of vitamin D plus evening primrose oil (EPO) supplement intake on lipid profiles and reduced oxidative stress among women with polycystic ovary syndrome (PCOS).,"[{'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Nasri', 'Affiliation': 'a Endocrinology and Metabolism Research Center, Department of Gynecology and Obstetrics , School of Medicine, Arak University of Medical Sciences , Arak , Iran.'}, {'ForeName': 'Sedighe', 'Initials': 'S', 'LastName': 'Akrami', 'Affiliation': 'a Endocrinology and Metabolism Research Center, Department of Gynecology and Obstetrics , School of Medicine, Arak University of Medical Sciences , Arak , Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'b Department of Gynecology and Obstetrics, School of Medicine , Iran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Taghizadeh', 'Affiliation': 'c Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences , Kashan , I.R . Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Behfar', 'Affiliation': 'c Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences , Kashan , I.R . Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mazandaranian', 'Affiliation': 'c Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences , Kashan , I.R . Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Kheiry', 'Affiliation': 'c Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences , Kashan , I.R . Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Memarzadeh', 'Affiliation': 'd Barij Medicinal Plants Research Center , Kashan , I.R . Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'c Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences , Kashan , I.R . Iran.'}]",Endocrine research,['10.1080/07435800.2017.1346661']
758,29196304,Long-Term Clinical Outcomes after Early Initiation of RRT in Critically Ill Patients with AKI.,"Whether earlier initiation of RRT in critically ill patients with AKI can improve outcomes remains debated. We examined follow-up data from a large clinical trial to prospectively investigate the long-term outcomes associated with the timing of RRT initiation in such patients. We extended the follow-up of patients in the Early Versus Delayed Initiation of RRT in Critically Ill Patients with AKI (ELAIN) Trial from 90 days to 1 year after randomization for 230 (99.6%) patients. The primary outcome was a composite of major adverse kidney events (persistent renal dysfunction, dialysis dependence, and mortality) at 1 year. Secondary outcomes included inflammatory markers. Overall, 72 of 111 (64.9%) and 106 of 119 (89.1%) patients met the primary outcome in the early (stage 2 AKI) and delayed (stage 3 AKI) initiation groups, respectively (odds ratio [OR] with early initiation, 0.23; 95% confidence interval [95% CI], 0.11 to 0.45; P < 0.001). The early initiation group had a 1-year all-cause mortality rate (56 of 111 [50.2%]) significantly lower than that of the delayed initiation group (83 of 119 [69.8%]; absolute difference, -19.6%; 95% CI, -32.0% to -7.2%; P <0.01). After 1 year, 16 of 55 (29.1%) and 23 of 36 (63.9%) surviving patients in the early and delayed groups, respectively, failed to recover renal function (absolute difference, -34.8%; 95% CI, -54.6% to -15.0%; P =0.001). In conclusion, early initiation of RRT in these critically ill patients with AKI significantly reduced the occurrence of major adverse kidney events, reduced mortality, and enhanced renal recovery at 1 year.",2018,"The early initiation group had a 1-year all-cause mortality rate (56 of 111 [50.2%]) significantly lower than that of the delayed initiation group (83 of 119 [69.8%]; absolute difference, -19.6%; 95% CI, -32.0% to -7.2%; P <0.01).","['Critically Ill Patients with AKI', 'Critically Ill Patients with AKI (ELAIN) Trial from 90 days to 1 year after randomization for 230 (99.6%) patients', 'critically ill patients with AKI']",['RRT'],"['renal function', 'occurrence of major adverse kidney events, reduced mortality, and enhanced renal recovery', '1-year all-cause mortality rate', 'inflammatory markers', 'composite of major adverse kidney events (persistent renal dysfunction, dialysis dependence, and mortality']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",[],"[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}]",,0.277284,"The early initiation group had a 1-year all-cause mortality rate (56 of 111 [50.2%]) significantly lower than that of the delayed initiation group (83 of 119 [69.8%]; absolute difference, -19.6%; 95% CI, -32.0% to -7.2%; P <0.01).","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Meersch', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine and.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Küllmar', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine and.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schmidt', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine and.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Gerss', 'Affiliation': 'Institute of Biostatistics and Clinical Research, University Hospital of Münster, Muenster, Germany.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Weinhage', 'Affiliation': 'Department of Pediatric Rheumatology and Immunology, University Hospital Münster, Muenster, Germany; and.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Margraf', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine and.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ermert', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine and.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kellum', 'Affiliation': 'Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine and zarbock@uni-muenster.de.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2017060694']
759,31522546,"Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial.","INTRODUCTION
Non-invasive vagus nerve stimulation (nVNS; gammaCore®) has the potential to prevent migraine days in patients with migraine on the basis of mechanistic rationale and pilot clinical data.
METHODS
This multicentre study included a 4-week run-in period, a 12-week double-blind period of randomised treatment with nVNS or sham, and a 24-week open-label period of nVNS. Patients were to administer two 120-second stimulations bilaterally to the neck three times daily (6-8 hours apart).
RESULTS
Of 477 enrolled patients, 332 comprised the intent-to-treat (ITT) population. Mean reductions in migraine days per month (primary outcome) were 2.26 for nVNS (n = 165; baseline, 7.9 days) and 1.80 for sham (n = 167; baseline, 8.1 days) ( p = 0.15). Results were similar across other outcomes. Upon observation of suboptimal adherence rates, post hoc analysis of patients with ≥ 67% adherence per month demonstrated significant differences between nVNS (n = 138) and sham (n = 140) for outcomes including reduction in migraine days (2.27 vs. 1.53; p = 0.043); therapeutic gains were greater in patients with aura than in those without aura. Most nVNS device-related adverse events were mild and transient, with application site discomfort being the most common.
CONCLUSIONS
Preventive nVNS treatment in episodic migraine was not superior to sham stimulation in the ITT population. The ""sham"" device inadvertently provided a level of active vagus nerve stimulation. Post hoc analysis showed significant effects of nVNS in treatment-adherent patients. Study identification and registration: PREMIUM; NCT02378844; https://clinicaltrials.gov/ct2/show/NCT02378844.",2019,"Mean reductions in migraine days per month (primary outcome) were 2.26 for nVNS (n = 165; baseline, 7.9 days) and 1.80 for sham (n = 167; baseline, 8.1 days)","['477 enrolled patients', 'patients with migraine', 'episodic migraine']","['invasive vagus nerve stimulation (nVNS', 'nVNS', 'Non-invasive vagus nerve stimulation (nVNS; gammaCore®']","['therapeutic gains', 'episodic migraine']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}]",477.0,0.392219,"Mean reductions in migraine days per month (primary outcome) were 2.26 for nVNS (n = 165; baseline, 7.9 days) and 1.80 for sham (n = 167; baseline, 8.1 days)","[{'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Faculty of Medicine, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK.""}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mohammad Al-Mahdi', 'Initials': 'MA', 'LastName': 'Al-Karagholi', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Sinclair', 'Affiliation': 'Metabolic Neurology, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Dimos', 'Initials': 'D', 'LastName': 'Mitsikostas', 'Affiliation': '1st Neurology Department, Aeginition Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Magis', 'Affiliation': 'Neurology Department and Pain Clinic, CHR East Belgium, Liège, Belgium.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pozo-Rosich', 'Affiliation': ""Headache Unit, Neurology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Irimia Sieira', 'Affiliation': 'Clinica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Miguel Ja', 'Initials': 'MJ', 'LastName': 'Làinez', 'Affiliation': 'Catholic University of Valencia, University Clinic Hospital, Valencia, Spain.'}, {'ForeName': 'Charly', 'Initials': 'C', 'LastName': 'Gaul', 'Affiliation': 'Migraine and Headache Clinic, Königstein, Germany.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Silver', 'Affiliation': 'The Walton Centre, Liverpool, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hoffmann', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK.""}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Marin', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Liebler', 'Affiliation': 'electroCore, Inc., Basking Ridge, New Jersey, USA.'}, {'ForeName': 'Michel D', 'Initials': 'MD', 'LastName': 'Ferrari', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419876920']
760,29532078,Comparison of Surgical and Medical Therapy for Type 2 Diabetes in Severely Obese Adolescents.,"Importance
Because of the substantial increase in the occurrence of type 2 diabetes in the pediatric population and the medical complications of this condition, therapies are urgently needed that will achieve better glycemic control than standard medical management.
Objective
To compare glycemic control in cohorts of severely obese adolescents with type 2 diabetes undergoing medical and surgical interventions.
Design, Setting, and Participants
A secondary analysis of data collected by the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) consortia was performed. Teen-LABS enrolled 242 adolescents (≤19 years of age) from March 1, 2007, through December 31, 2011. TODAY randomized 699 participants (aged 10-17 years) from July 24, 2004, through February 25, 2009. Data analysis was performed from July 6, 2015, to June 24, 2017. Anthropometric, clinical, and laboratory data from adolescents with severe obesity and type 2 diabetes who underwent treatment with metabolic or bariatric surgery in the Teen-LABS study or medical therapy in the TODAY study were compared.
Interventions
Teen-LABS participants underwent a primary bariatric surgical procedure; TODAY participants were randomized to receive metformin therapy alone or in combination with rosiglitazone or an intensive lifestyle intervention; insulin therapy was given in cases of progression of disease.
Main Outcomes and Measures
Glycemic control, body mass index, prevalence of elevated blood pressure, dyslipidemia, abnormal kidney function, and clinical adverse events were measured.
Results
Data from 30 participants from Teen-LABS (mean [SD] age at baseline, 16.9 [1.3] years; 21 [70%] female; 18 [66%] white) and 63 from TODAY (mean [SD] age at baseline, 15.3 [1.3] years; 28 [44%] female; 45 [71%] white) were analyzed. During 2 years, mean hemoglobin A1c concentration decreased from 6.8% (95% CI, 6.4%-7.3%) to 5.5% (95% CI, 4.7% -6.3%) in Teen-LABS and increased from 6.4% (95% CI, 6.1%-6.7%) to 7.8% (95% CI, 7.2%-8.3%) in TODAY. Compared with baseline, the body mass index decreased by 29% (95% CI, 24%-34%) in Teen-LABS and increased by 3.7% (95% CI, 0.8%-6.7%) in TODAY. Twenty-three percent of Teen-LABS participants required a subsequent operation during the 2-year follow-up.
Conclusions and Relevance
Compared with medical therapy, surgical treatment of severely obese adolescents with type 2 diabetes was associated with better glycemic control, reduced weight, and improvement of other comorbidities. These data support the need for a well-designed, prospective controlled study to define the role of surgery for adolescents with type 2 diabetes, including health and surgical outcomes.",2018,"Compared with baseline, the body mass index decreased by 29% (95% CI, 24%-34%) in Teen-LABS and increased by 3.7% (95% CI, 0.8%-6.7%) in TODAY.","['severely obese adolescents with type 2 diabetes', 'Interventions\n\n\nTeen-LABS participants underwent a primary bariatric surgical procedure; TODAY participants', 'Type 2 Diabetes in Severely Obese Adolescents', '699 participants (aged 10-17 years) from July 24, 2004, through February 25, 2009', 'adolescents with severe obesity and type 2 diabetes who underwent treatment with metabolic or bariatric surgery in the Teen-LABS study or medical therapy in the TODAY study were compared', 'cohorts of severely obese adolescents with type 2 diabetes undergoing medical and surgical interventions', '30 participants from Teen-LABS (mean [SD] age at baseline, 16.9 [1.3] years; 21 [70%] female; 18 [66%] white) and 63 from TODAY (mean [SD] age at baseline, 15.3 [1.3] years; 28 [44%] female; 45 [71%] white) were analyzed', 'adolescents with type 2 diabetes', 'Teen-LABS enrolled 242 adolescents (≤19 years of age) from March 1, 2007, through December 31, 2011']","['metformin therapy alone or in combination with rosiglitazone or an intensive lifestyle intervention; insulin therapy', 'Bariatric Surgery (Teen-LABS', 'Surgical and Medical Therapy']","['body mass index', 'Measures\n\n\nGlycemic control, body mass index, prevalence of elevated blood pressure, dyslipidemia, abnormal kidney function, and clinical adverse events', 'mean hemoglobin A1c concentration']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0549433', 'cui_str': 'Surgical intervention'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517578', 'cui_str': '15.3'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",699.0,0.0702868,"Compared with baseline, the body mass index decreased by 29% (95% CI, 24%-34%) in Teen-LABS and increased by 3.7% (95% CI, 0.8%-6.7%) in TODAY.","[{'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Inge', 'Affiliation': ""Department of Pediatric Surgery, Children's Hospital Colorado, University of Colorado, Denver, Aurora.""}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Department of Pediatrics, Joslin Diabetes Center, Boston, Massachusetts.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Jenkins', 'Affiliation': ""Department of Pediatrics and Surgery, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Marsha D', 'Initials': 'MD', 'LastName': 'Marcus', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Natasha I', 'Initials': 'NI', 'LastName': 'Leibel', 'Affiliation': 'Department of Pediatrics, Columbia University, New York, New York.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Brandt', 'Affiliation': ""Michael E. Debakey Department of Surgery, Texas Children's Hospital, Baylor College of Medicine, Houston.""}, {'ForeName': 'Morey', 'Initials': 'M', 'LastName': 'Haymond', 'Affiliation': ""Michael E. Debakey Department of Surgery, Texas Children's Hospital, Baylor College of Medicine, Houston.""}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Urbina', 'Affiliation': ""Department of Pediatrics and Surgery, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Lawrence M', 'Initials': 'LM', 'LastName': 'Dolan', 'Affiliation': ""Department of Pediatrics and Surgery, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Zeitler', 'Affiliation': ""Department of Pediatrics, Children's Hospital Colorado, University of Colorado, Denver, Aurora.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA pediatrics,['10.1001/jamapediatrics.2017.5763']
761,28822559,Antibiotic therapy for prevention of fistula in-ano after incision and drainage of simple perianal abscess: A randomized single blind clinical trial.,"BACKGROUND
Much controversy exists regarding the role of antibiotics in the development of fistula in-ano after incision and drainage. We evaluated the role of postoperative antibiotics in the prevention of fistula in-ano after incision and drainage of perianal abscess.
METHODS
In a randomized single blind clinical trial study, 307 patients were randomly selected from those referring for incision and drainage of perianal abscess at Shahid Faghihi Hospital, Shiraz, Iran, during September 2013 to September 2014. Patients were allocated randomly either to receive 7 days of oral metronidazole and ciprofloxacin in addition to their standard care or to only receive standard care without any antibiotics after they were discharged from the hospital. Patients were followed for 3 months and final results were evaluated. The study was registered at the clinical trial registry (www.irct.ir; Irct201311049936n7).
RESULTS
Seven patients were lost to follow-up. Those who used prophylactic antibiotics (n = 155) had significantly lower rates of fistula formation compared with those who did not use any medication (n = 144; P < .001). Men had higher rates of fistula formation (P = .002). Patients who used more cigarettes had higher rates of fistula development (P = .001). In the univariate analysis, only postoperative antibiotic use showed a protective role against fistula formation (odds ratio = 0.426; confidence interval, 0.206-0.881). In the regression analysis postoperative antibiotic use remained protective against fistula development (odds ratio = 0.371; confidence interval, 0.196-0.703), furthermore male sex presented as a risk factor for developing fistula in-ano (odds ratio = 3.11; confidence interval, 1.31-7.38).
CONCLUSION
Postoperative prophylactic antibiotic therapy including ciprofloxacin and metronidazole play an important role in preventing fistula in-ano formation. Considering the complications of fistula in-ano formation and the minor side effects of antibiotic therapy, based on our results, a 7-10 course of postoperative antibiotics is advised after incision and drainage of perianal abscess.",2017,Those who used prophylactic antibiotics (n = 155) had significantly lower rates of fistula formation compared with those who did not use any medication (n = 144; P < .001).,"['307 patients were randomly selected from those referring for incision and drainage of perianal abscess at Shahid Faghihi Hospital, Shiraz, Iran, during September 2013 to September 2014', 'fistula in-ano after incision and drainage of simple perianal abscess']","['Antibiotic therapy', 'prophylactic antibiotics', 'oral metronidazole and ciprofloxacin in addition to their standard care or to only receive standard care without any antibiotics', 'ciprofloxacin and metronidazole']","['rates of fistula formation', 'rates of fistula development', 'protective role against fistula formation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0193043', 'cui_str': 'Incision and drainage of perianal abscess (procedure)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0205929', 'cui_str': 'Anal Fistula'}, {'cui': 'C0152277', 'cui_str': 'Incision AND drainage (procedure)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0031019', 'cui_str': 'Perianal abscess (disorder)'}]","[{'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C3871468', 'cui_str': 'ciprofloxacin and metronidazole'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0035820', 'cui_str': 'Role'}]",307.0,0.0937157,Those who used prophylactic antibiotics (n = 155) had significantly lower rates of fistula formation compared with those who did not use any medication (n = 144; P < .001).,"[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ghahramani', 'Affiliation': 'Department of surgery, Colorectal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Minaie', 'Affiliation': 'Department of surgery, Colorectal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Arasteh', 'Affiliation': 'Non communicable Disease Research Center, Fasa University of Medical Sciences, Fasa, Iran; MPH Department, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: Peyman.arasteh@yahoo.com.'}, {'ForeName': 'Seyed Vahid', 'Initials': 'SV', 'LastName': 'Hosseini', 'Affiliation': 'Department of surgery, Colorectal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Izadpanah', 'Affiliation': 'Department of Surgery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali Mohammad', 'Initials': 'AM', 'LastName': 'Bananzadeh', 'Affiliation': 'Department of surgery, Colorectal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mahboobe', 'Initials': 'M', 'LastName': 'Ahmadbeigi', 'Affiliation': 'Post Graduate Dental Student, Student Research Committee, Department of Pediatrics, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Hooshanginejad', 'Affiliation': 'Department of Surgery, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Surgery,['10.1016/j.surg.2017.07.001']
762,29229589,"The Effect of Group Support Psychotherapy Delivered by Trained Lay Health Workers for Depression Treatment Among People with HIV in Uganda: Protocol of a Pragmatic, Cluster Randomized Trial.","BACKGROUND
There is limited information on the effectiveness of task shifting of mental health services in populations with HIV.
OBJECTIVE
This trial aims to evaluate the effectiveness of group support psychotherapy delivered by trained lay health workers to persons living with HIV (PLWH) with depression in primary care.
METHODS
Thirty eligible primary care health centers across three districts were randomly allocated to have their lay health workers trained to deliver group support psychotherapy (intervention arm) or group HIV education and treatment as usual (control arm) to PLWH with depression. Treated PLWH will be evaluated at baseline, after the end of treatment, and at 6-month intervals thereafter for 2 years. Primary outcomes will be the difference in follow-up proportions of participants with Mini International Neuropsychiatric Interview criteria for major depression and difference in follow-up function scores of participants in the intervention and control arms 6 months after the end of treatment. Secondary outcomes will include measures of self-esteem, posttraumatic stress symptoms, social support, stigma, adherence to antiretroviral therapy, viral load, and number of disability days, asset possession indices, and cost-effectiveness data. Primary and secondary outcomes as well as subgroup analyses will be conducted at the individual level using multilevel random effects regression analyses adjusting for clustering in health centers. A process evaluation using mixed methods to assess acceptability, feasibility, fidelity, causal mediating processes, and contextual influences in the trial will be conducted.
RESULTS
The trial has been approved by the Makerere College of Health Sciences School of Health Sciences Research Ethics Committee, the AIDS Support Organization, and the Uganda National Council of Science and Technology. A data and safety monitoring board has been put in place to monitor trial progress. A total of 1140 persons living with HIV have been recruited to the trial. An analysis of baseline and 6-month data is in progress. The results of this trial will not only be presented at national and international conferences but also submitted for publication in peer-reviewed journals and as a report to the funding agencies.
CONCLUSIONS
This cluster randomized trial will provide critical evidence to support culturally sensitive group-based psychotherapy for depression treatment in sub-Saharan Africa. Process evaluation outcomes will provide contextual information that health care and public health stakeholders can use to guide implementation decisions for their particular setting.
TRIAL REGISTRATION
Pan African Clinical Trials Registry (PACTR): 201608001738234; http://www.pactr.org/ATMWeb/ appmanager/atm/atmregistry?dar=true&tNo=PACTR201608001738234 (Archived by WebCite at http://www.webcitation.org/ 6vUAgAQlj).",2017,Primary outcomes will be the difference in follow-up proportions of participants with Mini International Neuropsychiatric Interview criteria for major depression and difference in follow-up function scores of participants in the intervention and control arms 6 months after the end of treatment.,"['populations with HIV', 'People with HIV in Uganda', 'persons living with HIV (PLWH) with depression in primary care', '1140 persons living with HIV have been recruited to the trial', 'Thirty eligible primary care health centers across three districts', 'Trained Lay Health Workers for Depression Treatment']","['health workers trained to deliver group support psychotherapy (intervention arm) or group HIV education and treatment as usual (control arm) to PLWH with depression', 'Group Support Psychotherapy', 'group support psychotherapy']","['acceptability, feasibility, fidelity, causal mediating processes, and contextual influences', 'follow-up proportions of participants with Mini International Neuropsychiatric Interview criteria for major depression and difference in follow-up function scores', 'measures of self-esteem, posttraumatic stress symptoms, social support, stigma, adherence to antiretroviral therapy, viral load, and number of disability days, asset possession indices, and cost-effectiveness data']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517539', 'cui_str': 'One thousand one hundred and forty'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}, {'cui': 'C0037438'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",30.0,0.247091,Primary outcomes will be the difference in follow-up proportions of participants with Mini International Neuropsychiatric Interview criteria for major depression and difference in follow-up function scores of participants in the intervention and control arms 6 months after the end of treatment.,"[{'ForeName': 'Etheldreda', 'Initials': 'E', 'LastName': 'Nakimuli-Mpungu', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Seggane', 'Initials': 'S', 'LastName': 'Musisi', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Kizito', 'Initials': 'K', 'LastName': 'Wamala', 'Affiliation': 'Department of Psychology, Center for Victims of Torture, Gulu, Uganda.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Okello', 'Affiliation': 'Department of Mental Health, Faculty of Medicine, Gulu University, Gulu, Uganda.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Ndyanabangi', 'Affiliation': 'Mental Health Program, Ministry of Health of Uganda, Kampala, Uganda.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Mojtabai', 'Affiliation': ""Department of Mental Health, Bloomberg's School of Public Health, Johns Hopkins University, Baltimore, MD, United States.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Nachega', 'Affiliation': 'Department of Epidemiology, Pittsburg Graduate School of Public Health, University of Pittsburg, Pittsburgh, PA, United States.'}, {'ForeName': 'Ofir', 'Initials': 'O', 'LastName': 'Harari', 'Affiliation': 'MTEK Sciences Inc, Vancouver, BC, Canada.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Mills', 'Affiliation': 'Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada.'}]",JMIR research protocols,['10.2196/resprot.8925']
763,28980870,"Comparison of myo-inositol and metformin on mental health parameters and biomarkers of oxidative stress in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.","INTRODUCTION
Data on comparison of myo-inositol and metformin on mental health parameters and biomarkers of oxidative stress in subjects with polycystic ovary syndrome (PCOS) are scarce. This purpose of this study was to compare of myo-inositol and metformin on mental health parameters and biomarkers of oxidative stress in subjects with PCOS.
METHODS
This randomized controlled trial was conducted among 60 subjects diagnosed with PCOS according to the Rotterdam criteria. Subjects were randomly assigned into two groups to intake either myo-inositol (n = 30) or metformin (n = 30) for 12 weeks. Parameters of mental health were recorded at baseline and after the 12-week intervention. Fasting blood samples were obtained at baseline and the end of the study to determine biomarkers of biomarkers of oxidative stress.
RESULTS
After the 12-week intervention, changes in beck depression inventory total score (-1.0 ± 1.7 vs. -0.3 ± 0.7, p = 0.03), general health questionnaire scores (-1.7 ± 2.9 vs. -0.5 ± 1.2, p = 0.02), depression anxiety and stress scale scores (-3.9 ± 6.4 vs. -0.9 ± 1.9, p = 0.01) and plasma total antioxidant capacity (TAC) concentrations (+106.1 ± 69.6 vs. +2.1 ± 132.4 mmol/L, p < 0.001) in the myo-inositol group were significantly different from the changes in these indicators in the metformin group. Myo-inositol supplementation for 12 weeks among patients with PCOS did not affect plasma glutathione and malondialdehyde levels.
CONCLUSIONS
Overall, our data supported that myo-inositol supplementation for 12 weeks among patients with PCOS had favorable effects on parameters of mental health and plasma TAC levels.",2018,"After the 12-week intervention, changes in beck depression inventory total score (-1.0 ± 1.7 vs. -0.3 ± 0.7, p = 0.03), general health questionnaire scores (-1.7 ± 2.9 vs. -0.5 ± 1.2, p = 0.02), depression anxiety and stress scale scores (-3.9 ± 6.4 vs. -0.9 ± 1.9, p = 0.01) and plasma total antioxidant capacity (TAC) concentrations (+106.1 ± 69.6 vs. +2.1 ± 132.4 mmol/L, p < 0.001) in the myo-inositol group were significantly different from the changes in these indicators in the metformin group.","['subjects with polycystic ovary syndrome (PCOS', 'women with polycystic ovary syndrome', '60 subjects diagnosed with PCOS according to the Rotterdam criteria', 'subjects with PCOS']","['placebo', 'metformin', 'Myo-inositol supplementation', 'myo-inositol and metformin', 'intake either myo-inositol (n\u2009=\u200930) or metformin']","['mental health parameters and biomarkers of oxidative stress', 'beck depression inventory total score', 'plasma total antioxidant capacity (TAC) concentrations', 'general health questionnaire scores', 'mental health', 'depression anxiety and stress scale scores', 'Fasting blood samples', 'mental health and plasma TAC levels', 'plasma glutathione and malondialdehyde levels']","[{'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}]",60.0,0.130252,"After the 12-week intervention, changes in beck depression inventory total score (-1.0 ± 1.7 vs. -0.3 ± 0.7, p = 0.03), general health questionnaire scores (-1.7 ± 2.9 vs. -0.5 ± 1.2, p = 0.02), depression anxiety and stress scale scores (-3.9 ± 6.4 vs. -0.9 ± 1.9, p = 0.01) and plasma total antioxidant capacity (TAC) concentrations (+106.1 ± 69.6 vs. +2.1 ± 132.4 mmol/L, p < 0.001) in the myo-inositol group were significantly different from the changes in these indicators in the metformin group.","[{'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Jamilian', 'Affiliation': 'a Department of Psychiatry , Arak University of Medical Sciences , Arak , Iran.'}, {'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Jamilian', 'Affiliation': 'b Endocrinology and Metabolism Research Center, Department of Gynecology and Obstetrics , School of Medicine, Arak University of Medical Sciences , Arak , Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Foroozanfard', 'Affiliation': 'c Department of Gynecology and Obstetrics, School of Medicine , Kashan University of Medical Sciences , Kashan , Iran.'}, {'ForeName': 'Faraneh', 'Initials': 'F', 'LastName': 'Afshar Ebrahimi', 'Affiliation': 'c Department of Gynecology and Obstetrics, School of Medicine , Kashan University of Medical Sciences , Kashan , Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'd Research Center for Biochemistry and Nutrition in Metabolic Diseases , Kashan University of Medical Sciences , Kashan , Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'd Research Center for Biochemistry and Nutrition in Metabolic Diseases , Kashan University of Medical Sciences , Kashan , Iran.'}]",Journal of psychosomatic obstetrics and gynaecology,['10.1080/0167482X.2017.1383381']
764,31773882,Efficacy of a povidone-iodine foam dressing (Betafoam) on diabetic foot ulcer.,"This study aimed to assess the efficacy of a new povidone-iodine (PVP-I) foam dressing (Betafoam) vs foam dressing (Medifoam) for the management of diabetic foot ulcers. This study was conducted between March 2016 and September 2017 at 10 sites in Korea. A total of 71 patients (aged ≥19 years) with type 1/2 diabetes and early-phase diabetic foot ulcers (Wagener classification grade 1/2) were randomised to treatment with PVP-I foam dressing or foam dressing for 8 weeks. Wound healing, wound infection, patient satisfaction, and adverse events (AEs) were assessed. The PVP-I foam and foam dressing groups were comparable in the proportion of patients with complete wound healing within 8 weeks (44.4% vs 42.3%, P = .9191), mean (±SD) number of days to complete healing (31.00 ± 15.07 vs 33.27 ± 12.60 days; P = .6541), and infection rates (11.1% vs 11.4%; P = 1.0000). Median satisfaction score (scored from 0 to 10) at the final visit was also comparable between groups (10 vs 9, P = .2889). There was no significant difference in AE incidence (27.8% vs 17.1%, P = .2836), and none of the reported AEs had a causal relationship with the dressings. The results of this study suggest that PVP-I foam dressing has wound-healing efficacy comparable with foam dressing, with no notable safety concerns. This study was funded by Mundipharma Korea Ltd and registered at ClinicalTrials.gov (identifier NCT02732886).",2020,"There was no significant difference in AE incidence (27.8% vs 17.1%, P = .2836), and none of the reported AEs had a causal relationship with the dressings.","['diabetic foot ulcers', 'diabetic foot ulcer', 'March 2016 and September 2017 at 10 sites in Korea', '71 patients (aged ≥19\u2009years) with type 1/2 diabetes and early-phase diabetic foot ulcers (Wagener classification grade 1/2']","['povidone-iodine foam dressing (Betafoam', 'PVP-I foam dressing or foam dressing for 8\u2009weeks', 'new povidone-iodine (PVP-I) foam dressing (Betafoam) vs foam dressing (Medifoam']","['Wound healing, wound infection, patient satisfaction, and adverse events (AEs', 'Median satisfaction score', 'infection rates', 'AE incidence', 'mean (±SD) number of days to complete healing', 'complete wound healing']","[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C3164124', 'cui_str': 'Foam dressing'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",71.0,0.0926451,"There was no significant difference in AE incidence (27.8% vs 17.1%, P = .2836), and none of the reported AEs had a causal relationship with the dressings.","[{'ForeName': 'Heui C', 'Initials': 'HC', 'LastName': 'Gwak', 'Affiliation': 'Department of Orthopedic Surgery, Busan Paik Hospital, Inje University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Seung H', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Orthopaedic Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jinwoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sejin', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, KangBuk Samsung Hospital, SungKyunKwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ki-Sun', 'Initials': 'KS', 'LastName': 'Sung', 'Affiliation': 'Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hak-Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Korea University Guro Hospital, Seoul, South Korea.'}, {'ForeName': 'Dongil', 'Initials': 'D', 'LastName': 'Chun', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, Soonchunhyang University Seoul Hospital, Seoul, South Korea.'}, {'ForeName': 'Kyungmin', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University Bundang Hospital, Kyungki, South Korea.'}, {'ForeName': 'Jae-Hoon', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, the Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Kyunghee', 'Initials': 'K', 'LastName': 'Kwak', 'Affiliation': 'Department of Medical Affairs, Mundipharma Korea Ltd, Seoul, South Korea.'}, {'ForeName': 'Hyung-Jin', 'Initials': 'HJ', 'LastName': 'Chung', 'Affiliation': 'Department of Orthopaedics, Inje University Sanggye Paik Hospital, Seoul, South Korea.'}]",International wound journal,['10.1111/iwj.13236']
765,23735680,"Vaccination of volunteers with low-dose, live-attenuated, dengue viruses leads to serotype-specific immunologic and virologic profiles.","There are currently no vaccines or therapeutics to prevent dengue disease which ranges in severity from asymptomatic infections to life-threatening illness. The National Institute of Allergy and Infectious Diseases (NIAID) Division of Intramural Research has developed live, attenuated vaccines to each of the four dengue serotypes (DENV-1-DENV-4). Two doses (10PFU and 1000PFU) of three monovalent vaccines were tested in human clinical trials to compare safety and immunogenicity profiles. DEN4Δ30 had been tested previously at multiple doses. The three dengue vaccine candidates tested (DEN1Δ30, DEN2/4Δ30, and DEN3Δ30/31) were very infectious, each with a human infectious dose 50%≤ 10PFU. Further, infectivity rates ranged from 90 to 100% regardless of dose, excepting DEN2/4Δ30 which dropped from 100% at the 1000PFU dose to 60% at the 10PFU dose. Mean geometric peak antibody titers did not differ significantly between doses for DEN1Δ30 (92 ± 19 vs. 214 ± 97, p=0.08); however, significant differences were observed between the 10PFU and 1000PFU doses for DEN2/4Δ30, 19 ± 9 vs. 102 ± 25 (p=0.001), and DEN3Δ30/31, 119 ± 135 vs. 50 ± 50 (p=0.046). No differences in the incidences of rash, neutropenia, or viremia were observed between doses for any vaccines, though the mean peak titer of viremia for DEN1Δ30 was higher at the 1000PFU dose (0.5 ± 0 vs. 1.1 ± 0.1, p=0.007). These data demonstrate that a target dose of 1000PFU for inclusion of each dengue serotype into a tetravalent vaccine is likely to be safe and generate a balanced immune response for all serotypes.",2013,"No differences in the incidences of rash, neutropenia, or viremia were observed between doses for any vaccines, though the mean peak titer of viremia for DEN1Δ30 was higher at the 1000PFU dose (0.5 ± 0 vs. 1.1 ± 0.1, p=0.007).",[],[],"['incidences of rash, neutropenia, or viremia', 'Mean geometric peak antibody titers', 'infectivity rates', 'mean peak titer of viremia for DEN1Δ30']",[],[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0030657', 'cui_str': 'infectivity'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.0662892,"No differences in the incidences of rash, neutropenia, or viremia were observed between doses for any vaccines, though the mean peak titer of viremia for DEN1Δ30 was higher at the 1000PFU dose (0.5 ± 0 vs. 1.1 ± 0.1, p=0.007).","[{'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'Lindow', 'Affiliation': 'University of Vermont College of Medicine, Vaccine Testing Center and Unit of Infectious Diseases, 95 Carrigan Drive, Stafford Hall 110, Burlington, VT, USA.'}, {'ForeName': 'Anna P', 'Initials': 'AP', 'LastName': 'Durbin', 'Affiliation': ''}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Whitehead', 'Affiliation': ''}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Pierce', 'Affiliation': ''}, {'ForeName': 'Marya P', 'Initials': 'MP', 'LastName': 'Carmolli', 'Affiliation': ''}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2013.05.075']
766,31851001,Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial.,"BACKGROUND
There is limited evidence for the use of postoperative antibiotics for simple appendicitis (SA) in children. Our aim was to conduct a prospective double-blinded randomized controlled trial to investigate this after a laparoscopic appendicectomy.
METHODS
Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution. Patients were randomized intraoperatively to receive either 2 postoperative intravenous doses of placebo or antibiotics (Abx). All patients received a dose of Abx at induction of anesthesia. Primary outcome was the incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation. Data are reported as number of cases (%), median (range), relative risk, and analyzed using Mann Whitney U test, Chi-square test, as appropriate, a P-value ≤0.05 was considered significant.
RESULTS
A total of 304 patients were randomized. Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis. One hundred twenty-two patients received placebo and 121 Intravenous Abx. There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7). There was also no difference in the preoperative blood results. A total of 9 WIs occurred: 8/122 (6.6%) placebo versus 1/121 (0.8%) Abx, P = 0.01 [relative risk for WI 1.83 (95% confidence interval: 1.145-2.201)]. There were no intra-abdominal abscess in either groups.
CONCLUSIONS
This prospective randomized double blinded randomized controlled trial has revealed a significant decrease in WI rates by giving 2 postoperative intravenous doses of Abx, suggesting postoperative Abx are of benefit in SA.",2019,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","['simple appendicitis (SA) in children', '304 patients were randomized', 'One hundred twenty-two patients received', 'Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis', 'Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution']","['Laparoscopic Appendicectomy', 'placebo or antibiotics (Abx', 'placebo', 'laparoscopic appendicectomy']","['intra-abdominal abscess', 'WI rates', 'postoperative length of stay in a hospital', 'incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation']","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0243001', 'cui_str': 'Abscess, Intra-Abdominal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",243.0,0.816238,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mennie', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Panabokke', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Sharman Tan', 'Initials': 'ST', 'LastName': 'Tanny', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pacilli', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ferguson', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Ramesh M', 'Initials': 'RM', 'LastName': 'Nataraja', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}]",Annals of surgery,['10.1097/SLA.0000000000003732']
767,28877862,Effectiveness of a Web-Based Tailored Intervention With Virtual Assistants Promoting the Acceptability of HPV Vaccination Among Mothers of Invited Girls: Randomized Controlled Trial.,"BACKGROUND
In 2010, the human papillomavirus (HPV) vaccination was introduced in the Dutch National Immunization Program for 12-year-old girls, aiming to reduce the incidence of cervical cancer in women. HPV vaccination uptake turned out to be lower than expected: 61% versus 70%, respectively. Mothers were shown to play the most important role in the immunization decision about this vaccination. They had also expressed their need for interactive personal information about the HPV vaccination over and above the existing universal general information. To improve the effectiveness of the existing education about the HPV vaccination, we systematically developed a Web-based tailored intervention with virtual assistants providing mothers of girls to be invited with tailored feedback on their decision making about the HPV vaccination.
OBJECTIVE
The aim of this study was to evaluate the effectiveness of the Web-based tailored intervention for promoting HPV vaccination acceptance by means of a randomized controlled trial (RCT).
METHODS
Mothers were recruited via the Dutch vaccination register (Praeventis) (n=36,000) and three Web-based panels (n=2483). Those who gave informed consent (N=8062) were randomly assigned to the control (n=4067) or intervention condition (n=3995). HPV vaccination uptake, as registered by Praeventis once the HPV vaccination round was completed, was used as the primary outcome. Secondary outcomes were differential scores across conditions between baseline (before the provided access to the new tailored intervention) and follow-up (just before the first vaccination) regarding the mothers' degree of informed decision making (IDM), decisional conflict, and critical determinants of HPV vaccination uptake among which are intention, attitude, risk perception, and outcome beliefs.
RESULTS
Intention-to-treat analysis (N=8062) showed a significant positive effect of the intervention on IDM, decisional conflict, and nearly all determinants of HPV vaccination uptake (P<.001). No effect was found on uptake (P=.60). This may be attributed to the overall high uptake rates in both conditions. Mothers evaluated the intervention as highly positive, including the website as well as the virtual assistants that were used to deliver the tailored feedback.
CONCLUSIONS
This computer-tailored intervention has the potential to improve HPV vaccination acceptability and IDM and to decrease decisional conflict among mothers of invited girls. Implications for future research are discussed.
TRIAL REGISTRATION
Trialregister.nl NTR4935; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4935 (Archived by WebCite at http://www.webcitation.org/6srT7l9EM).",2017,This computer-tailored intervention has the potential to improve HPV vaccination acceptability and IDM and to decrease decisional conflict among mothers of invited girls.,"['Mothers were recruited via the Dutch vaccination register (Praeventis) (n=36,000) and three Web-based panels (n=2483', 'Mothers of Invited Girls', 'mothers of invited girls']",['Web-based tailored intervention'],"['HPV vaccination acceptability and IDM', 'decisional conflict', 'HPV vaccination uptake', 'IDM, decisional conflict, and nearly all determinants of HPV vaccination uptake', ""mothers' degree of informed decision making (IDM), decisional conflict, and critical determinants of HPV vaccination uptake among which are intention, attitude, risk perception, and outcome beliefs"", 'Vaccination', 'Acceptability of HPV']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",,0.0895052,This computer-tailored intervention has the potential to improve HPV vaccination acceptability and IDM and to decrease decisional conflict among mothers of invited girls.,"[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Pot', 'Affiliation': 'Netherlands Organization for Applied Scientific Research (TNO), Child Health, Leiden, Netherlands.'}, {'ForeName': 'Theo Gwm', 'Initials': 'TG', 'LastName': 'Paulussen', 'Affiliation': 'Netherlands Organization for Applied Scientific Research (TNO), Child Health, Leiden, Netherlands.'}, {'ForeName': 'Robert Ac', 'Initials': 'RA', 'LastName': 'Ruiter', 'Affiliation': 'Department of Work and Social Psychology, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Eekhout', 'Affiliation': 'Netherlands Organization for Applied Scientific Research (TNO), Child Health, Leiden, Netherlands.'}, {'ForeName': 'Hester E', 'Initials': 'HE', 'LastName': 'de Melker', 'Affiliation': 'National Institute for Public Health and the Environment (RIVM), Centre for Infectious Disease Control, Bilthoven, Netherlands.'}, {'ForeName': 'Maxine Ea', 'Initials': 'ME', 'LastName': 'Spoelstra', 'Affiliation': 'Department of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Hilde M', 'Initials': 'HM', 'LastName': 'van Keulen', 'Affiliation': 'Netherlands Organization for Applied Scientific Research (TNO), Child Health, Leiden, Netherlands.'}]",Journal of medical Internet research,['10.2196/jmir.7449']
768,28820855,Resistance exercise order does not affect the magnitude and duration of post-exercise blood pressure in older women.,"The aim of this study was to compare the effects of two resistance exercise order on post-exercise blood pressure (BP) in trained, non-hypertensive older women. Sixteen women (68.3 ± 3.3 years, 63.5 ± 11.6 kg, 157.5 ± 5.1 cm) performed two sessions witheight exercises (3 sets of 8-12 repetitions) in distinct orders (from multi- to single-joint exercises [MS] or from single- to multi-joint exercises [SM]) and a control session, without exercise. Blood pressure and heart rate were obtained pre and post-sessions (60 min). Post-exercise hypotension was observed for systolic and mean BP in both the MS session (systolic BP: -6.9 mmHg, mean BP: -3.3 mmHg, P< 0.05) and SM session (systolic BP: -4.6 mmHg; mean BP: -1.1 mmHg). Post-exercise heart rate was higher than pre-session values until 30 min of recovery in both training sessions. Furthermore, systolic and mean blood pressure, and heart rate were lower than the values obtained in the control session (30 to 60 min and 0 min, respectively; P<0.05). There were no differences between the SM and MS sessions in any variable or at any moment. In conclusion, resistance exercise order does not interfere in the magnitude and duration of post-exercise hypotension in trained, non-hypertensive older women.",2017,There were no differences between the SM and MS sessions in any variable or at any moment.,"['Sixteen women (68.3 ± 3.3 years, 63.5 ± 11.6 kg, 157.5 ± 5.1 cm) performed two', 'trained, non-hypertensive older women', 'older women', 'hypertensive older women']","['resistance exercise order on post-exercise blood pressure (BP', 'Resistance exercise', 'sessions witheight exercises (3 sets of 8-12 repetitions) in distinct orders (from multi- to single-joint exercises [MS] or from single- to multi-joint exercises [SM]) and a control session, without exercise']","['Post-exercise heart rate', 'Furthermore, systolic and mean blood pressure, and heart rate', 'Blood pressure and heart rate', 'magnitude and duration of post-exercise blood pressure', 'systolic and mean BP']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0338416,There were no differences between the SM and MS sessions in any variable or at any moment.,"[{'ForeName': 'Crisieli M', 'Initials': 'CM', 'LastName': 'Tomeleri', 'Affiliation': 'a Metabolism, Nutrition, and Exercise Laboratory. Londrina State University. Londrina, Brazil. b Department of Physical Education, Federal University of Vale do São Francisco, Petrolina, Brazil. c Department of Physical Education, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil. d Department of Physical Education, Faculty of Physical Education and Sport, State University of Londrina, Londrina, PR, Brazil.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': ''}, {'ForeName': 'Mariana F', 'Initials': 'MF', 'LastName': 'Souza', 'Affiliation': ''}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Gerage', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Marcori', 'Affiliation': ''}, {'ForeName': 'Kessi Cassiane', 'Initials': 'KC', 'LastName': 'Iarosz', 'Affiliation': ''}, {'ForeName': 'Crivaldo Gomes', 'Initials': 'CG', 'LastName': 'Cardoso-Júnior', 'Affiliation': ''}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002177']
769,31581959,The effects of omega-3 fatty acids on neuropsychological functioning and brain morphology in mid-life adults: a randomized clinical trial.,"BACKGROUND
The diet of most adults is low in fish and, therefore, provides limited quantities of the long-chain, omega-3 fatty acids (LCn-3FAs), eicosapentaenoic and docosahexaenoic acids (EPA, DHA). Since these compounds serve important roles in the brain, we sought to determine if healthy adults with low-LCn-3FA consumption would exhibit improvements in neuropsychological performance and parallel changes in brain morphology following repletion through fish oil supplementation.
METHODS
In a randomized, controlled trial, 271 mid-life adults (30-54 years of age, 118 men, 153 women) consuming ⩽300 mg/day of LCn-3FAs received 18 weeks of supplementation with fish oil capsules (1400 mg/day of EPA and DHA) or matching placebo. All participants completed a neuropsychological test battery examining four cognitive domains: psychomotor speed, executive function, learning/episodic memory, and fluid intelligence. A subset of 122 underwent neuroimaging before and after supplementation to measure whole-brain and subcortical tissue volumes.
RESULTS
Capsule adherence was over 95%, participant blinding was verified, and red blood cell EPA and DHA levels increased as expected. Supplementation did not affect performance in any of the four cognitive domains. Exploratory analyses revealed that, compared to placebo, fish oil supplementation improved executive function in participants with low-baseline DHA levels. No changes were observed in any indicator of brain morphology.
CONCLUSIONS
In healthy mid-life adults reporting low-dietary intake, supplementation with LCn-3FAs in moderate dose for moderate duration did not affect neuropsychological performance or brain morphology. Whether salutary effects occur in individuals with particularly low-DHA exposure requires further study.",2020,"Exploratory analyses revealed that, compared to placebo, fish oil supplementation improved executive function in participants with low-baseline DHA levels.","['individuals with particularly low-DHA', 'mid-life adults', '271 mid-life adults (30-54 years of age, 118 men, 153 women) consuming ⩽300 mg/day of LCn-3FAs received 18 weeks of', 'healthy adults with low-LCn-3FA consumption', 'participants with low-baseline DHA levels']","['placebo, fish oil supplementation', 'supplementation with fish oil capsules (1400 mg/day of EPA and DHA) or matching placebo', 'omega-3 fatty acids']","['neuropsychological functioning and brain morphology', 'neuropsychological test battery examining four cognitive domains: psychomotor speed, executive function, learning/episodic memory, and fluid intelligence', 'red blood cell EPA and DHA levels', 'executive function', 'Capsule adherence']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]",271.0,0.572238,"Exploratory analyses revealed that, compared to placebo, fish oil supplementation improved executive function in participants with low-baseline DHA levels.","[{'ForeName': 'Regina L', 'Initials': 'RL', 'LastName': 'Leckie', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Lehman', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Gianaros', 'Affiliation': 'Psychology Department, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Kirk I', 'Initials': 'KI', 'LastName': 'Erickson', 'Affiliation': 'Psychology Department, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'University of Pittsburgh School of Nursing, Pittsburgh, PA, USA.'}, {'ForeName': 'Dora C H', 'Initials': 'DCH', 'LastName': 'Kuan', 'Affiliation': 'Psychology Department, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Manuck', 'Affiliation': 'Psychology Department, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Ryan', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Jeffrey K', 'Initials': 'JK', 'LastName': 'Yao', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Muldoon', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}]",Psychological medicine,['10.1017/S0033291719002617']
770,28550194,Risk of Severe Hypoglycemia in Type 1 Diabetes Over 30 Years of Follow-up in the DCCT/EDIC Study.,"OBJECTIVE
During the Diabetes Control and Complications Trial (DCCT), intensive diabetes therapy achieving a mean HbA 1c of ∼7% was associated with a threefold increase in the rate of severe hypoglycemia (defined as requiring assistance) compared with conventional diabetes therapy with a mean HbA 1c of 9% (61.2 vs. 18.7 per 100 patient-years). After ∼30 years of follow-up, we investigated the rates of severe hypoglycemia in the DCCT/Epidemiology of Diabetes Inverventions and Complications (EDIC) cohort.
RESEARCH DESIGN AND METHODS
Rates of severe hypoglycemia were reported quarterly during DCCT and annually during EDIC (i.e., patient recall of episodes in the preceding 3 months). Risk factors influencing the rate of severe hypoglycemia over time were investigated.
RESULTS
One-half of the DCCT/EDIC cohort reported episodes of severe hypoglycemia. During EDIC, rates of severe hypoglycemia fell in the former DCCT intensive treatment group but rose in the former conventional treatment group, resulting in similar rates (36.6 vs. 40.8 episodes per 100 patient-years, respectively) with a relative risk of 1.12 (95% CI 0.91-1.37). A preceding episode of severe hypoglycemia was the most powerful predictor of subsequent episodes. Entry into the DCCT study as an adolescent was associated with an increased risk of severe hypoglycemia, whereas insulin pump use was associated with a lower risk. Severe hypoglycemia rates increased with lower HbA 1c similarly among participants in both treatment groups.
CONCLUSIONS
Rates of severe hypoglycemia have equilibrated over time between the two DCCT/EDIC treatment groups in association with advancing duration of diabetes and similar HbA 1c levels. Severe hypoglycemia persists and remains a challenge for patients with type 1 diabetes across their life span.",2017,"During EDIC, rates of severe hypoglycemia fell in the former DCCT intensive treatment group but rose in the former conventional treatment group, resulting in similar rates (36.6 vs. 40.8 episodes per 100 patient-years, respectively) with a relative risk of 1.12 (95% CI 0.91-1.37).","['Rates of severe hypoglycemia were reported quarterly during DCCT and annually during EDIC (i.e., patient recall of episodes in the preceding 3 months', 'patients with type 1 diabetes across their life span']",[],"['Severe hypoglycemia', 'rates of severe hypoglycemia', 'rate of severe hypoglycemia', 'Severe hypoglycemia rates', 'episodes of severe hypoglycemia', 'rates of severe hypoglycemia fell', 'severe hypoglycemia', 'risk of severe hypoglycemia']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0870809', 'cui_str': 'Lifespan'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0342283,"During EDIC, rates of severe hypoglycemia fell in the former DCCT intensive treatment group but rose in the former conventional treatment group, resulting in similar rates (36.6 vs. 40.8 episodes per 100 patient-years, respectively) with a relative risk of 1.12 (95% CI 0.91-1.37).","[{'ForeName': 'Rose A', 'Initials': 'RA', 'LastName': 'Gubitosi-Klug', 'Affiliation': 'Case Western Reserve University, Cleveland, OH rose.gubitosi-klug@case.edu.'}, {'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'Braffett', 'Affiliation': 'George Washington University, Rockville, MD.'}, {'ForeName': 'Neil H', 'Initials': 'NH', 'LastName': 'White', 'Affiliation': 'Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Sherwin', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': 'F John', 'Initials': 'FJ', 'LastName': 'Service', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Lachin', 'Affiliation': 'George Washington University, Rockville, MD.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Tamborlane', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc16-2723']
771,21829138,"The cDNA-derived investigational human parainfluenza virus type 3 vaccine rcp45 is well tolerated, infectious, and immunogenic in infants and young children.","BACKGROUND
Human parainfluenza virus type 3 (HPIV3) is an important yet underappreciated cause of lower respiratory tract illness in children, and a licensed vaccine is not yet available.
METHODS
A live-attenuated investigational HPIV3 vaccine virus designated rcp45 was derived from cDNA by using reverse genetics. rcp45 is genetically similar to the biologically derived cp45 vaccine virus and contains all of the known attenuating mutations of cp45, but has the advantage of a short, well-characterized passage history. We evaluated the tolerability, infectivity, and immunogenicity of 2 intranasal doses of rcp45 administered 4 to 10 weeks apart in a placebo-controlled, double-blind trial. A total of 45 infants and children between 6 and 36 months of age participated in this study. Tolerability and antibody responses to vaccine or placebo were assessed in all recipients. Infectivity was assessed by quantitation of vaccine virus shedding in a subset of vaccinated children.
RESULTS
rcp45 was well tolerated and highly infectious in HPIV3-seronegative children. A second dose of vaccine administered 4 to 10 weeks after the first dose was restricted in replication and did not boost serum antibody responses. The stability of 9 cp45 mutations, including the 6 major attenuating mutations, was examined and confirmed for viral isolates from 10 children.
CONCLUSIONS
The level of attenuation and immunogenicity of cDNA-derived rcp45 is comparable to what was previously observed with the biologically derived cp45 vaccine, and preliminary data suggest that the attenuating mutations in this vaccine virus are genetically stable. Continued clinical development of rcp45 is warranted.",2011,"rcp45 is genetically similar to the biologically derived cp45 vaccine virus and contains all of the known attenuating mutations of cp45, but has the advantage of a short, well-characterized passage history.","['45 infants and children between 6 and 36 months of age participated in this study', 'infants and young children']","['vaccine or placebo', 'rcp45', 'vaccine']","['tolerability, infectivity, and immunogenicity', 'tolerated and highly infectious', 'Tolerability and antibody responses']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030657', 'cui_str': 'infectivity'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}]",45.0,0.222302,"rcp45 is genetically similar to the biologically derived cp45 vaccine virus and contains all of the known attenuating mutations of cp45, but has the advantage of a short, well-characterized passage history.","[{'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Karron', 'Affiliation': 'Center for Immunization Research, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. rkarron@jhsph.edu'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Bhagvanji', 'Initials': 'B', 'LastName': 'Thumar', 'Affiliation': ''}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Surman', 'Affiliation': ''}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Schmidt', 'Affiliation': ''}]",The Pediatric infectious disease journal,['10.1097/INF.0b013e31822ea24f']
772,28277699,Harnessing the placebo effect: Exploring the influence of physician characteristics on placebo response.,"OBJECTIVE
Research on placebo/nocebo effects suggests that expectations can influence treatment outcomes, but placebo/nocebo effects are not always evident. This research demonstrates that a provider's social behavior moderates the effect of expectations on physiological outcomes.
METHODS
After inducing an allergic reaction in participants through a histamine skin prick test, a health care provider administered a cream with no active ingredients and set either positive expectations (cream will reduce reaction) or negative expectations (cream will increase reaction). The provider demonstrated either high or low warmth, or either high or low competence.
RESULTS
The impact of expectations on allergic response was enhanced when the provider acted both warmer and more competent and negated when the provider acted colder and less competent.
CONCLUSION
This study suggests that placebo effects should be construed not as a nuisance variable with mysterious impact but instead as a psychological phenomenon that can be understood and harnessed to improve treatment outcomes. (PsycINFO Database Record",2017,"The impact of expectations on allergic response was enhanced when the provider acted both warmer and more competent and negated when the provider acted colder and less competent.
","['participants through a histamine skin prick test, a health care provider administered a']","['cream with no active ingredients and set either positive expectations (cream will reduce reaction) or negative expectations (cream', 'placebo']",['allergic response'],"[{'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0430561', 'cui_str': 'Prick test (procedure)'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.287479,"The impact of expectations on allergic response was enhanced when the provider acted both warmer and more competent and negated when the provider acted colder and less competent.
","[{'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Howe', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'J Parker', 'Initials': 'JP', 'LastName': 'Goyer', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'Alia J', 'Initials': 'AJ', 'LastName': 'Crum', 'Affiliation': 'Department of Psychology, Stanford University.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000499']
773,31578889,Individualized Neurofeedback Training May Help Achieve Long-Term Improvement of Working Memory in Children With ADHD.,"Background . Children with attention deficit hyperactivity disorder (ADHD) may suffer from working memory deficits, which can adversely affect their academic performance. Neurofeedback training may enhance working memory and provide a solution to this problem. Aim . To investigate the effect of frequency-neurofeedback on working memory in children with ADHD and to check if the effect is long-lasting. Method . Forty-eight children with ADHD (aged 6-12 years) were randomly assigned either to a neurofeedback with training parameters chosen to take into account each child's peak alpha frequency (PAF) or to a waiting list control group. Each trained child underwent 19-channel electroencephalography (EEG). All children had average intelligence and none were receiving treatment, such as medications, for ADHD. Prior to the training, MOXO and n-back tests were performed. Next, neurofeedback training sessions with frequency bands for theta and beta ranges determined using each child's PAF were carried out for 10 weeks. Training parameters were set to increase amplitudes in the low beta range and to decrease amplitudes in the theta and high beta frequency ranges. The n-back test was performed again right after the training and then a year later. Results . During the first n-back test, children from both groups responded correctly to more than 43% of the stimuli. During the second test, children from the waiting list responded correctly to an average of 49% of the stimuli, while children who underwent the neurofeedback training were correct, on average, 69% of the time (significant difference, P < .001). During the third n-back test a year later, children from the waiting list responded correctly to 53% of the stimuli, while those who underwent the neurofeedback training responded correctly to nearly 71%. Conclusion . This study found a statistically significant improvement in a measure of working memory in children who did 10 to 12 sessions of neurofeedback training with training frequency ranges for theta and beta defined according to each child's PAF. The beneficial effects were still present a year after training.",2020,This study found a statistically significant improvement in a measure of working memory in children who did 10 to 12 sessions of neurofeedback training with training frequency ranges for theta and beta defined according to each child's PAF.,"['Children with attention deficit hyperactivity disorder (ADHD', 'children with ADHD', 'children who did 10 to 12 sessions of', 'Children With ADHD', 'Forty-eight children with ADHD (aged 6-12 years']","[""neurofeedback with training parameters chosen to take into account each child's peak alpha frequency (PAF) or to a waiting list control group"", 'Individualized Neurofeedback Training', 'Neurofeedback training', 'neurofeedback training', 'frequency-neurofeedback', '19-channel electroencephalography (EEG']",['working memory'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}]",48.0,0.0191063,This study found a statistically significant improvement in a measure of working memory in children who did 10 to 12 sessions of neurofeedback training with training frequency ranges for theta and beta defined according to each child's PAF.,"[{'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Dobrakowski', 'Affiliation': 'Humanitas University in Sosnowiec, Psychology Institute, Sosnowiec, Poland.'}, {'ForeName': 'Grażyna', 'Initials': 'G', 'LastName': 'Łebecka', 'Affiliation': 'Humanitas University in Sosnowiec, Psychology Institute, Sosnowiec, Poland.'}]",Clinical EEG and neuroscience,['10.1177/1550059419879020']
774,32492138,No effect of resveratrol supplementation after 6 months on insulin sensitivity in overweight adults: a randomized trial.,"BACKGROUND
Effects of resveratrol on metabolic health have been studied in several short-term human clinical trials, with conflicting results. Next to dose, the duration of the clinical trials may explain the lack of effect in some studies, but long-term studies are still limited.
OBJECTIVES
The objective of this study was to investigate the effects of 6-mo resveratrol supplementation on metabolic health outcome parameters.
METHODS
Forty-one overweight men and women (BMI: 27-35 kg/m2; aged 40-70 y) completed the study. In this parallel-group, double-blind clinical trial, participants were randomized to receive either 150 mg/d of resveratrol (n = 20) or placebo (n = 21) for 6 mo. The primary outcome of the study was insulin sensitivity, using the Matsuda index. Secondary outcome measures were intrahepatic lipid (IHL) content, body composition, resting energy metabolism, blood pressure, plasma markers, physical performance, quality of life, and quality of sleep. Postintervention differences between the resveratrol and placebo arms were evaluated by ANCOVA adjusting for corresponding preintervention variables.
RESULTS
Preintervention, no differences were observed between the 2 treatment arms. Insulin sensitivity was not affected after 6 mo of resveratrol treatment (adjusted mean Matsuda index: 5.18 ± 0.35 in the resveratrol arm compared with 5.50 ± 0.34 in the placebo arm), although there was a significant difference in postintervention glycated hemoglobin (HbA1c) between the arms (P = 0.007). The adjusted means showed that postintervention HbA1c was lower on resveratrol (35.8 ± 0.43 mmol/mol) compared with placebo (37.6 ± 0.44 mmol/mol). No postintervention differences were found in IHL, body composition, blood pressure, energy metabolism, physical performance, or quality of life and sleep between treatment arms.
CONCLUSIONS
After 6 mo of resveratrol supplementation, insulin sensitivity was unaffected in the resveratrol arm compared with the placebo arm. Nonetheless, HbA1c was lower in overweight men and women in the resveratrol arm. This trial was registered at Clinicaltrials.gov as NCT02565979.",2020,"No postintervention differences were found in IHL, body composition, blood pressure, energy metabolism, physical performance, or quality of life and sleep between treatment arms.
","['overweight adults', 'Forty-one overweight men and women', 'BMI: 27-35 kg/m2; aged 40-70 y) completed the study']","['6-mo resveratrol supplementation', 'placebo', 'resveratrol supplementation']","['insulin sensitivity, using the Matsuda index', 'metabolic health outcome parameters', 'postintervention glycated hemoglobin (HbA1c', 'postintervention HbA1c', 'insulin sensitivity', 'IHL, body composition, blood pressure, energy metabolism, physical performance, or quality of life and sleep', 'Insulin sensitivity', 'intrahepatic lipid (IHL) content, body composition, resting energy metabolism, blood pressure, plasma markers, physical performance, quality of life, and quality of sleep']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",41.0,0.562601,"No postintervention differences were found in IHL, body composition, blood pressure, energy metabolism, physical performance, or quality of life and sleep between treatment arms.
","[{'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'de Ligt', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Bergman', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Rodrigo Mancilla', 'Initials': 'RM', 'LastName': 'Fuentes', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Essers', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Moonen-Kornips', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Havekes', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Vera B', 'Initials': 'VB', 'LastName': 'Schrauwen-Hinderling', 'Affiliation': 'Department of Radiology and Nuclear Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa125']
775,28317086,Process Evaluation of a Randomized Controlled Trial of Group Support Psychotherapy for Depression Treatment Among People with HIV/AIDS in Northern Uganda.,"We describe the process evaluation for a randomized controlled trial that compared group support psychotherapy (GSP) with group HIV education for treatment of depression among people with HIV. Process data were obtained using mixed methods. Variables evaluated were indicators of feasibility and acceptability; causal mediating processes and contextual influences. GSP was feasible and acceptable. Potential mediating variables between GSP and reduction of depression were improved emotional and social support, better coping strategies, and pursuit of livelihoods. Culturally sensitive intervention content facilitated intervention delivery. These data complement the trial outcomes, and may provide a contextualized description of how GSP treats depression.",2017,"Potential mediating variables between GSP and reduction of depression were improved emotional and social support, better coping strategies, and pursuit of livelihoods.","['people with HIV', 'People with HIV/AIDS in Northern Uganda']","['Group Support Psychotherapy', 'psychotherapy (GSP) with group HIV education', 'GSP']","['feasibility and acceptability; causal mediating processes and contextual influences', 'emotional and social support, better coping strategies, and pursuit of livelihoods']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0037438'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}]",,0.120552,"Potential mediating variables between GSP and reduction of depression were improved emotional and social support, better coping strategies, and pursuit of livelihoods.","[{'ForeName': 'Etheldreda', 'Initials': 'E', 'LastName': 'Nakimuli-Mpungu', 'Affiliation': 'College of Health Sciences, Makerere University, Kampala, Uganda. ethelmpungu@yahoo.com.'}, {'ForeName': 'Kizito', 'Initials': 'K', 'LastName': 'Wamala', 'Affiliation': 'Center for Victims of Torture, Gulu, Uganda.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Okello', 'Affiliation': 'Department of Psychiatry, Gulu University, Gulu, Uganda.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Ndyanabangi', 'Affiliation': 'Ministry of Health of Uganda, Kampala, Uganda.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Kanters', 'Affiliation': 'Precision Health Economics, Vancouver, Canada.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Mojtabai', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Jean B', 'Initials': 'JB', 'LastName': 'Nachega', 'Affiliation': 'Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mills', 'Affiliation': 'Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Seggane', 'Initials': 'S', 'LastName': 'Musisi', 'Affiliation': 'College of Health Sciences, Makerere University, Kampala, Uganda.'}]",Community mental health journal,['10.1007/s10597-017-0129-4']
776,28142296,"Probiotic supplementation and the effects on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.","The aim of the current study was to assess the effects of probiotic supplementation on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome (PCOS). In a randomized, double-blind, placebo-controlled trial, 60 women with PCOS were randomized to receive probiotic capsule (n = 30) or placebo (n = 30) for 12 weeks. Consumption of probiotic supplements resulted in a significant reduction in weight (-0.5 ± 0.4 vs. +0.1 ± 1.0 kg, p = 0.004) and BMI (-0.2 ± 0.2 vs. +0.03 ± 0.4 kg/m 2 , p = 0.004) compared with the placebo. In addition, compared with the placebo, probiotic administration was associated with a significant decrease in fasting plasma glucose (-2.4 ± 8.4 vs. +2.1 ± 7.0 mg/dL, p = 0.02), serum insulin concentrations (-2.0 ± 5.8 vs. +1.6 ± 5.0 μIU/mL, p = 0.01), homoeostasis model of assessment-insulin resistance (-0.5 ± 1.4 vs. +0.3 ± 1.1, p = 0.01), homoeostatic model assessment-beta cell function (-7.5 ± 22.3 vs. +6.3 ± 21.7, p = 0.01), serum triglycerides (-13.3 ± 51.3 vs. +13.6 ± 37.1 mg/dL, p= 0.02) and a significant increase in quantitative insulin sensitivity check index (QUICKI) (+0.006 ± 0.01 vs. -0.005 ± 0.02, p = 0.01). When we adjusted the analysis for baseline values of biochemical parameters, age and baseline BMI, except for QUICKI (p = 0.08), other findings did not alter. We found that probiotic supplementation among PCOS women for 12 weeks had favourable effects on weight loss, markers of insulin resistance, triglycerides and VLDL-cholesterol concentrations.",2017,"In addition, compared with the placebo, probiotic administration was associated with a significant decrease in fasting plasma glucose (-2.4 ± 8.4 vs. +2.1 ± 7.0 mg/dL, p = 0.02), serum insulin concentrations (-2.0 ± 5.8 vs. +1.6 ± 5.0 μIU/mL, p = 0.01), homoeostasis model of assessment-insulin resistance (-0.5 ± 1.4 vs. +0.3 ± 1.1, p = 0.01), homoeostatic model assessment-beta cell function (-7.5 ± 22.3 vs. +6.3 ± 21.7, p = 0.01), serum triglycerides (-13.3 ± 51.3 vs. +13.6 ± 37.1 mg/dL, p= 0.02) and a significant increase in quantitative insulin sensitivity check index (QUICKI) (+0.006 ± 0.01 vs. -0.005 ± 0.02, p = 0.01).","['women with polycystic ovary syndrome', 'women with polycystic ovary syndrome (PCOS', '60 women with PCOS']","['placebo', 'Probiotic supplementation', 'probiotic supplementation', 'probiotic supplements', 'probiotic capsule']","['serum insulin concentrations', 'BMI', 'quantitative insulin sensitivity check index (QUICKI', 'weight loss, glycaemia and lipid profiles', 'weight', 'weight loss, markers of insulin resistance, triglycerides and VLDL-cholesterol concentrations', 'serum triglycerides', 'homoeostatic model assessment-beta cell function', 'homoeostasis model of assessment-insulin resistance', 'fasting plasma glucose']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",60.0,0.744294,"In addition, compared with the placebo, probiotic administration was associated with a significant decrease in fasting plasma glucose (-2.4 ± 8.4 vs. +2.1 ± 7.0 mg/dL, p = 0.02), serum insulin concentrations (-2.0 ± 5.8 vs. +1.6 ± 5.0 μIU/mL, p = 0.01), homoeostasis model of assessment-insulin resistance (-0.5 ± 1.4 vs. +0.3 ± 1.1, p = 0.01), homoeostatic model assessment-beta cell function (-7.5 ± 22.3 vs. +6.3 ± 21.7, p = 0.01), serum triglycerides (-13.3 ± 51.3 vs. +13.6 ± 37.1 mg/dL, p= 0.02) and a significant increase in quantitative insulin sensitivity check index (QUICKI) (+0.006 ± 0.01 vs. -0.005 ± 0.02, p = 0.01).","[{'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Ahmadi', 'Affiliation': 'a Department of Gynecology and Obstetrics, School of Medicine , Iran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Jamilian', 'Affiliation': 'c Endocrinology and Metabolism Research Center, Department of Gynecology and Obstetrics, School of Medicine , Arak University of Medical Sciences , Arak , Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karamali', 'Affiliation': 'a Department of Gynecology and Obstetrics, School of Medicine , Iran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tajabadi-Ebrahimi', 'Affiliation': 'd Science Department, Science Faculty , Islamic Azad University, Tehran Central branch , Tehran , Iran.'}, {'ForeName': 'Parvaneh', 'Initials': 'P', 'LastName': 'Jafari', 'Affiliation': 'e Department of Microbiology, Science Faculty , Islamic Azad University, Arak branch , Arak , Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Taghizadeh', 'Affiliation': 'f Research Center for Biochemistry and Nutrition in Metabolic Diseases , Kashan University of Medical Sciences , Kashan , Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Memarzadeh', 'Affiliation': 'g Barij Medicinal Plants Research Center , Kashan , Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'f Research Center for Biochemistry and Nutrition in Metabolic Diseases , Kashan University of Medical Sciences , Kashan , Iran.'}]","Human fertility (Cambridge, England)",['10.1080/14647273.2017.1283446']
777,28209296,Best time to assess complete clinical response after chemoradiotherapy in squamous cell carcinoma of the anus (ACT II): a post-hoc analysis of randomised controlled phase 3 trial.,"BACKGROUND
Guidelines for anal cancer recommend assessment of response at 6-12 weeks after starting treatment. Using data from the ACT II trial, we determined the optimum timepoint to assess clinical tumour response after chemoradiotherapy.
METHODS
The previously reported ACT II trial was a phase 3 randomised trial of patients of any age with newly diagnosed, histologically confirmed, squamous cell carcinoma of the anus without metastatic disease from 59 centres in the UK. We randomly assigned patients (by minimisation) to receive either intravenous mitomycin (one dose of 12 mg/m 2 on day 1) or intravenous cisplatin (one dose of 60 mg/m 2 on days 1 and 29), with intravenous fluorouracil (one dose of 1000 mg/m 2 per day on days 1-4 and 29-32) and radiotherapy (50·4 Gy in 28 daily fractions); and also did a second randomisation after initial therapy to maintenance chemotherapy (fluorouracil and cisplatin) or no maintenance chemotherapy. The primary outcome was complete clinical response (the absence of primary and nodal tumour by clinical examination), in addition to overall survival and progression-free survival from time of randomisation. In this post-hoc analysis, we analysed complete clinical response at three timepoints: 11 weeks from the start of chemoradiotherapy (assessment 1), 18 weeks from the start of chemoradiotherapy (assessment 2), and 26 weeks from the start of chemoradiotherapy (assessment 3) as well as the overall and progression-free survival estimates of patients with complete clinical response or without complete clinical response at each assessment. We analysed both the overall trial population and a subgroup of patients who had attended each of the three assessments by modified intention-to-treat. This study is registered at controlled-trials.com, ISRCTN 26715889.
FINDINGS
We enrolled 940 patients from June 4, 2001, until Dec 16, 2008. Complete clinical response was achieved in 492 (52%) of 940 patients at assessment 1 (11 weeks), 665 (71%) of patients at assessment 2 (18 weeks), and 730 (78%) of patients at assessment 3 (26 weeks). 691 patients attended all three assessments and in this subgroup, complete clinical response was reported in 441 (64%) patients at assessment 1, 556 (80%) at assessment 2, and 590 (85%) at assessments 3. 151 (72%) of the 209 patients who had not had a complete clinical response at assessment 1 had a complete clinical response by assessment 3. In the overall trial population of 940 patients, 5 year overall survival in patients who had a clinical response at assessments 1, 2, 3 was 83% (95% CI 79-86), 84% (81-87), and 87% (84-89), respectively and was 72% (66-78), 59% (49-67), and 46% (37-55) for patients who did not have a complete clinical response at assessments 1, 2, 3, respectively. In the subgroup of 691 patients, 5 year overall survival in patients who had a clinical response at assessment 1, 2, 3 was 85% (81-88), 86% (82-88), and 87% (84-90), respectively, and was 75% (68-80), 61% (50-70), and 48% (36-58) for patients who did not have a complete clinical response at assessment 1, 2, 3, respectively. Similarly, progression-free survival in both the overall trial population and the subgroup was longer in patients who had a complete clinical response, compared with patients who did not have a complete clinical response, at all three assessments.
INTERPRETATION
Many patients who do not have a complete clinical response when assessed at 11 weeks after commencing chemoradiotherapy do in fact respond by 26 weeks, and the earlier assessment could lead to some patients having unnecessary surgery. Our data suggests that the optimum time for assessment of complete clinical response after chemoradiotherapy for patients with squamous cell carcinoma of the anus is 26 weeks from starting chemoradiotherapy. We suggest that guidelines should be revised to indicate that later assessment is acceptable.
FUNDING
Cancer Research UK.",2017,"Complete clinical response was achieved in 492 (52%) of 940 patients at assessment 1 (11 weeks), 665 (71%) of patients at assessment 2 (18 weeks), and 730 (78%) of patients at assessment 3 (26 weeks).","['patients with squamous cell carcinoma', 'We enrolled 940 patients from June 4, 2001, until Dec 16, 2008', 'patients of any age with newly diagnosed, histologically confirmed, squamous cell carcinoma of the anus without metastatic disease from 59 centres in the UK', '691 patients', 'squamous cell carcinoma of the anus (ACT II', 'overall trial population and a subgroup of patients who had attended each of the three assessments by modified intention-to-treat']","['radiotherapy (50·4 Gy in 28 daily fractions); and also did a second randomisation after initial therapy to maintenance chemotherapy (fluorouracil and cisplatin) or no maintenance chemotherapy', 'intravenous fluorouracil', 'intravenous cisplatin', 'intravenous mitomycin']","['complete clinical response', 'complete clinical response (the absence of primary and nodal tumour by clinical examination), in addition to overall survival and progression-free survival', 'progression-free survival', 'Complete clinical response', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C4517905', 'cui_str': '940'}, {'cui': 'C1720302', 'cui_str': 'Until'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0003461', 'cui_str': 'Anus'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0481504', 'cui_str': 'Maintenance Chemotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",940.0,0.460988,"Complete clinical response was achieved in 492 (52%) of 940 patients at assessment 1 (11 weeks), 665 (71%) of patients at assessment 2 (18 weeks), and 730 (78%) of patients at assessment 3 (26 weeks).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Glynne-Jones', 'Affiliation': 'Mount Vernon Centre for Cancer Treatment, Northwood, Leeds, UK. Electronic address: rob.glynnejones@nhs.net.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sebag-Montefiore', 'Affiliation': 'University of Leeds, Leeds Cancer Centre, Leeds, UK.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Meadows', 'Affiliation': 'Cancer Research UK and University College London Cancer Trials Centre, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Rubina', 'Initials': 'R', 'LastName': 'Begum', 'Affiliation': 'Cancer Research UK and University College London Cancer Trials Centre, London, UK.'}, {'ForeName': 'Fawzi', 'Initials': 'F', 'LastName': 'Adab', 'Affiliation': 'North Staffordshire Royal Infirmary, Stoke, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Benstead', 'Affiliation': 'Cheltenham General Hospital, Cheltenham, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Harte', 'Affiliation': 'Belfast City Hospital Cancer Centre, Belfast, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Northampton General Hospital, Northampton, UK.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Beare', 'Affiliation': 'Cancer Research UK and University College London Cancer Trials Centre, London, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'Cancer Research UK and University College London Cancer Trials Centre, London, UK.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Kadalayil', 'Affiliation': 'Faculty of Natural and Environmental Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(17)30071-2']
778,31905097,"Effectiveness of Cervical Spine High-Velocity, Low-Amplitude Thrust Added to Behavioral Education, Soft Tissue Mobilization, and Exercise for People With Temporomandibular Disorder With Myalgia: A Randomized Clinical Trial.","OBJECTIVE
To determine the immediate and short-term effects of adding cervical spine high-velocity, low-amplitude thrust (HVLAT) to behavioral education, soft tissue mobilization, and a home exercise program on pain and dysfunction for people with a primary complaint of temporomandibular disorder (TMD) with myalgia.
DESIGN
Randomized clinical trial.
METHODS
Fifty individuals with TMD were randomly assigned to receive cervical HVLAT or sham manipulation for 4 visits over 4 weeks. Participants in both groups received other treatments, including standardized behavioral education, soft tissue mobilization, and a home exercise program. Primary outcomes included maximal mouth opening, the numeric pain-rating scale, the Jaw Functional Limitation Scale (JFLS), the Tampa Scale of Kinesiophobia for TMD (TSK-TMD), and a global rating of change (GROC). Self-report and objective measurements were taken at baseline, immediately after initial treatment, and follow-ups of 1 week and 4 weeks. A 2-by-4 mixed-model analysis of variance was used, with intervention group as the between-subjects factor and time as the within-subject factor. Separate analyses of variance were performed for dependent variables, and the hypothesis of interest was the group-by-time interaction.
RESULTS
There was no significant interaction for maximal mouth opening, the numeric pain-rating scale, or secondary measures. There were significant 2-way interactions for the JFLS ( d = 0.60) and TSK-TMD ( d = 0.80). The HVLAT group had lower fear at 4 weeks and improved jaw function earlier (1 week). The GROC favored the HVLAT group, with significant differences in successful outcomes noted immediately after baseline treatment (thrust, 6/25; sham, 0/25) and at 4 weeks (thrust, 17/25; sham, 10/25).
CONCLUSION
Both groups improved over time; however, differences between groups were small. There were significant differences between groups for the JFLS, TSK-TMD, and GROC. The additive clinical effect of cervical HVLAT to standard care remains unclear for treating TMD. J Orthop Sports Phys Ther 2020;50(8):455-465. Epub 6 Jan 2020. doi:10.2519/jospt.2020.9175 .",2020,Significant 2-way interactions were noted in JFLS (d=0.60) and TSK-TMD (d=0.80).,"['Individuals With Temporomandibular Disorder (TMD) With Myalgia', 'individuals with a primary complaint of temporomandibular disorder (TMD) with myalgia', 'Fifty individuals with TMD (n=50']","['cervical HVLAT or sham manipulation', 'Cervical Spine High Velocity Low Amplitude Thrust Added to Behavioral Education, Soft Tissue Mobilization, and Exercise', 'HVLAT', 'standardized behavioral education, soft tissue mobilization, and a HEP', 'cervical spine high velocity low amplitude thrust (HVLAT) added to behavioral education, soft tissue mobilization, and a home exercise program (HEP', 'JFLS']","['JFLS, TSK-TMD, and GROC', 'TSK-TMD), and Global Rating of Change (GROC', 'lower fear at 4-weeks and improved jaw function', 'pain and dysfunction', 'maximal mouth opening (MMO), Numeric Pain Rating Scale (NPRS), Jaw Functional Limitation Scale (JFLS), Tampa Scale of Kinesiophobia', 'successful outcomes', 'GROC']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0686940', 'cui_str': 'Soft tissue mobilization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449198', 'cui_str': 'HEP (body structure)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",50.0,0.0853835,Significant 2-way interactions were noted in JFLS (d=0.60) and TSK-TMD (d=0.80).,"[{'ForeName': 'Breanna', 'Initials': 'B', 'LastName': 'Reynolds', 'Affiliation': ''}, {'ForeName': 'Emilio J', 'Initials': 'EJ', 'LastName': 'Puentedura', 'Affiliation': ''}, {'ForeName': 'Morey J', 'Initials': 'MJ', 'LastName': 'Kolber', 'Affiliation': ''}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cleland', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2020.9175']
779,28162999,"Health-related quality of life with adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): secondary outcomes of a multinational, randomised, double-blind, phase 3 trial.","BACKGROUND
The EORTC 18071 phase 3 trial compared adjuvant ipilimumab with placebo in patients with stage III melanoma. The primary endpoint, recurrence-free survival, was significantly longer in the ipilimumab group than in the placebo group. Investigator-reported toxic effects of ipilimumab consisted mainly of skin, gastrointestinal, endocrine, and hepatic immune-related adverse events. Adjuvant treatment with ipilimumab in this setting was approved in October, 2014, by the US Food and Drug Administration based on the results of the primary outcome of this trial. Here, we report the results of the secondary endpoint, health-related quality of life (HRQoL), of this trial.
METHODS
EORTC 18071 was a multinational, double-blind, randomised, phase 3 trial in patients with stage III cutaneous melanoma (excluding lymph node metastasis ≤1 mm or in-transit metastasis) in 19 countries worldwide. Participants were randomly assigned (1:1) centrally by an interactive voice response system, to receive either ipilimumab 10 mg/kg or placebo every 3 weeks for four doses, then every 3 months for up to 3 years. Using a minimisation technique, randomisation was stratified by disease stage and geographical region. HRQoL was assessed with the EORTC QLQ-C30 quality-of-life instrument at baseline, weeks 4, 7, 10, and 24, and every 12 weeks thereafter up to 2 years, irrespective of disease progression. Results were summarised by timepoint and in a longitudinal manner in the intention-to-treat population. Two summary scores were calculated for each HRQoL scale: the average score reported during induction (ipilimumab or placebo at a dose of 10 mg/kg, administered as one single dose at the start of days 1, 22, 43, and 64-ie, four doses in 3 weeks), and the average score reported after induction. A predefined threshold of a 10 point difference between arms was considered clinically relevant. The primary HRQoL endpoint was the global health scale, with the predefined hypothesis of no clinically relevant differences after induction between groups. This trial is registered with EudraCT, number 2007-001974-10, and ClinicalTrials.gov, number NCT00636168.
FINDINGS
Between July 10, 2008, and Aug 1, 2011, 951 patients were randomly assigned to treatment: 475 in the ipilimumab group and 476 in the placebo group. Compliance with completing the HRQoL questionnaire was 893 (94%) of 951 patients at baseline, 693 (75%) of 924 at week 24, and 354 (51%) of 697 at week 108. Patient mean global health scores during (77·32 [SD 17·36] vs 72·96 [17·82]; p=0·00011) and after induction (76·48 [17·52] vs 72·32 [18·60]; p=0·00067) were statistically significantly different between groups but were not clinically relevant. Mean global health scores differed most between the groups at week 7 (77 [SD 19] in the placebo group vs 72 [22] in the ipilimumab group) and week 10 (77 [20] vs 70 [23]). Mean HRQoL scores differed by more than 10 points at week 10 between treatment groups for diarrhoea (7·67 [SD 17·05] for placebo vs 18·17 [28·35] for ipilimumab) and insomnia (15·17 [22·53] vs 25·60 [29·19]).
INTERPRETATION
Despite increased toxicity, which led to treatment discontinuation for most patients during the induction phase of ipilimumab administration, overall HRQoL, as measured by the EORTC QLQ-C30, was similar between groups, as no clinically relevant differences (10 points or more) in global health status scores were observed during or after induction. Clinically relevant deterioration for some symptoms was observed at week 10, but after induction, no clinically relevant differences remained. Together with the primary analysis, results from this trial show that treatment with ipilimumab results in longer recurrence-free survival compared with that for treatment with placebo, with little impairment in HRQoL despite grade 3-4 investigator-reported adverse events.
FUNDING
Bristol-Myers Squibb.",2017,"The primary endpoint, recurrence-free survival, was significantly longer in the ipilimumab group than in the placebo group.","['patients with stage III melanoma', 'patients with stage III cutaneous melanoma (excluding lymph node metastasis ≤1 mm or in-transit metastasis) in 19 countries worldwide', 'Between July 10, 2008, and Aug 1, 2011, 951 patients were randomly assigned to treatment: 475 in the ipilimumab group and 476 in the']","['placebo', 'ipilimumab', 'ipilimumab 10 mg/kg or placebo', 'adjuvant ipilimumab versus placebo', 'induction (ipilimumab or placebo']","['global health status scores', 'health-related quality of life (HRQoL', 'Patient mean global health scores', 'global health scale', 'toxicity', 'Mean HRQoL scores', 'recurrence-free survival', 'Mean global health scores', 'longer recurrence-free survival', 'EORTC QLQ-C30 quality-of-life instrument']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517786', 'cui_str': '475 (qualifier value)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]",951.0,0.769247,"The primary endpoint, recurrence-free survival, was significantly longer in the ipilimumab group than in the placebo group.","[{'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Coens', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: corneel.coens@eortc.be.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'IOV-IRCCS, Melanoma Oncology Unit, Padova, Italy.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'University of Zürich Hospital, Zürich, Switzerland.'}, {'ForeName': 'Jedd D', 'Initials': 'JD', 'LastName': 'Wolchok', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'The Angeles Clinic and Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori Fondazione ""G. Pascale"", Naples, Italy.'}, {'ForeName': 'Jon M', 'Initials': 'JM', 'LastName': 'Richards', 'Affiliation': 'Oncology Specialists S C, Park Ridge, IL, USA.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'Assistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Saint-Louis, Paris.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Ferraresi', 'Affiliation': 'Istituti Fisioterapici Ospitalieri, Rome, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Smylie', 'Affiliation': 'Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Weber', 'Affiliation': 'H Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maio', 'Affiliation': 'University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bottomley', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Srividya', 'Initials': 'S', 'LastName': 'Kotapati', 'Affiliation': 'Bristol-Myers Squibb, Wallingford, CT, USA.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'de Pril', 'Affiliation': ""Bristol-Myers Squibb, Braine-l'Alleud, Belgium.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Testori', 'Affiliation': 'European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Gustave Roussy Cancer Campus Grand Paris, Villejuif, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(17)30015-3']
780,27841024,"Effect of exercise intensity on postprandial lipemia, markers of oxidative stress, and endothelial function after a high-fat meal.","The aim of this study was to compare the effects of 2 different exercise intensities on postprandial lipemia, oxidative stress markers, and endothelial function after a high-fat meal (HFM). Eleven young men completed 2-day trials in 3 conditions: rest, moderate-intensity exercise (MI-Exercise) and heavy-intensity exercise (HI-Exercise). Subjects performed an exercise bout or no exercise (Rest) on the evening of day 1. On the morning of day 2, an HFM was provided. Blood was sampled at fasting (0 h) and every hour from 1 to 5 h during the postprandial period for triacylglycerol (TAG), thiobarbituric acid reactive substance (TBARS), and nitrite/nitrate (NOx) concentrations. Flow-mediated dilatation (FMD) was also analyzed. TAG concentrations were reduced in exercise conditions compared with Rest during the postprandial period (P < 0.004). TAG incremental area under the curve (iAUC) was smaller after HI-Exercise compared with Rest (P = 0.012). TBARS concentrations were reduced in MI-Exercise compared with Rest (P < 0.041). FMD was higher in exercise conditions than Rest at 0 h (P < 0.02) and NOx concentrations were enhanced in MI-Exercise compared with Rest at 0 h (P < 0.01). These results suggest that acute exercise can reduce lipemia after an HFM. However, HI-Exercise showed to be more effective in reducing iAUC TAG, which might suggest higher protection against postprandial TAG enhancement. Conversely, MI-Exercise can be beneficial to attenuate the susceptibility of oxidative damage induced by an HFM and to increase endothelial function in the fasted state compared with Rest.",2016,FMD was higher in exercise conditions than Rest at 0 h (P < 0.02) and NOx concentrations were enhanced in MI-Exercise compared with Rest at 0 h (P < 0.01).,['Eleven young men completed 2-day trials in 3 conditions'],"['rest, moderate-intensity exercise (MI-Exercise) and heavy-intensity exercise (HI-Exercise', 'exercise intensity', 'exercise bout or no exercise (Rest']","['FMD', 'TAG concentrations', 'triacylglycerol (TAG), thiobarbituric acid reactive substance (TBARS), and nitrite/nitrate (NOx) concentrations', 'endothelial function', 'postprandial lipemia, oxidative stress markers, and endothelial function', 'TAG incremental area under the curve (iAUC', 'NOx concentrations', 'postprandial lipemia, markers of oxidative stress, and endothelial function', 'TBARS concentrations', 'Flow-mediated dilatation (FMD']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1706412', 'cui_str': 'Lipemia'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]",11.0,0.0455644,FMD was higher in exercise conditions than Rest at 0 h (P < 0.02) and NOx concentrations were enhanced in MI-Exercise compared with Rest at 0 h (P < 0.01).,"[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Lopes Krüger', 'Affiliation': 'a Program of Human Movement Sciences, Faculty of Physical Education, Physiotherapy and Dance (ESEFID), Federal University of Rio Grande do Sul (UFRGS), 750 Felizardo Street, Porto Alegre, Rio Grande do Sul 90690-200, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Costa Teixeira', 'Affiliation': 'a Program of Human Movement Sciences, Faculty of Physical Education, Physiotherapy and Dance (ESEFID), Federal University of Rio Grande do Sul (UFRGS), 750 Felizardo Street, Porto Alegre, Rio Grande do Sul 90690-200, Brazil.'}, {'ForeName': 'Juliano', 'Initials': 'J', 'LastName': 'Boufleur Farinha', 'Affiliation': 'a Program of Human Movement Sciences, Faculty of Physical Education, Physiotherapy and Dance (ESEFID), Federal University of Rio Grande do Sul (UFRGS), 750 Felizardo Street, Porto Alegre, Rio Grande do Sul 90690-200, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Cauduro Oliveira Macedo', 'Affiliation': 'a Program of Human Movement Sciences, Faculty of Physical Education, Physiotherapy and Dance (ESEFID), Federal University of Rio Grande do Sul (UFRGS), 750 Felizardo Street, Porto Alegre, Rio Grande do Sul 90690-200, Brazil.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pinto Boeno', 'Affiliation': 'a Program of Human Movement Sciences, Faculty of Physical Education, Physiotherapy and Dance (ESEFID), Federal University of Rio Grande do Sul (UFRGS), 750 Felizardo Street, Porto Alegre, Rio Grande do Sul 90690-200, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Rech', 'Affiliation': 'a Program of Human Movement Sciences, Faculty of Physical Education, Physiotherapy and Dance (ESEFID), Federal University of Rio Grande do Sul (UFRGS), 750 Felizardo Street, Porto Alegre, Rio Grande do Sul 90690-200, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'a Program of Human Movement Sciences, Faculty of Physical Education, Physiotherapy and Dance (ESEFID), Federal University of Rio Grande do Sul (UFRGS), 750 Felizardo Street, Porto Alegre, Rio Grande do Sul 90690-200, Brazil.'}, {'ForeName': 'Ronei', 'Initials': 'R', 'LastName': 'Silveira Pinto', 'Affiliation': 'a Program of Human Movement Sciences, Faculty of Physical Education, Physiotherapy and Dance (ESEFID), Federal University of Rio Grande do Sul (UFRGS), 750 Felizardo Street, Porto Alegre, Rio Grande do Sul 90690-200, Brazil.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Reischak-Oliveira', 'Affiliation': 'a Program of Human Movement Sciences, Faculty of Physical Education, Physiotherapy and Dance (ESEFID), Federal University of Rio Grande do Sul (UFRGS), 750 Felizardo Street, Porto Alegre, Rio Grande do Sul 90690-200, Brazil.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",[]
781,28139405,"Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial.","BACKGROUND
Bendamustine plus rituximab is a standard of care for the management of patients with relapsed or refractory chronic lymphocytic leukaemia. New therapies are needed to improve clinically relevant outcomes in these patients. We assessed the efficacy and safety of adding idelalisib, a first-in-class targeted phosphoinositide-3-kinase δ inhibitor, to bendamustine plus rituximab in this population.
METHODS
For this international, multicentre, double-blind, placebo-controlled trial, adult patients (≥18 years) with relapsed or refractory chronic lymphocytic leukaemia requiring treatment who had measurable lymphadenopathy by CT or MRI and disease progression within 36 months since their last previous therapy were enrolled. Patients were randomly assigned (1:1) by a central interactive web response system to receive bendamustine plus rituximab for a maximum of six cycles (bendamustine: 70 mg/m 2 intravenously on days 1 and 2 for six 28-day cycles; rituximab: 375 mg/m 2 on day 1 of cycle 1, and 500 mg/m 2 on day 1 of cycles 2-6) in addition to either twice-daily oral idelalisib (150 mg) or placebo until disease progression or intolerable study drug-related toxicity. Randomisation was stratified by high-risk features (IGHV, del[17p], or TP53 mutation) and refractory versus relapsed disease. The primary endpoint was progression-free survival assessed by an independent review committee in the intention-to-treat population. This trial is ongoing and is registered with ClinicalTrials.gov, number NCT01569295.
FINDINGS
Between June 26, 2012, and Aug 21, 2014, 416 patients were enrolled and randomly assigned to the idelalisib (n=207) and placebo (n=209) groups. At a median follow-up of 14 months (IQR 7-18), median progression-free survival was 20·8 months (95% CI 16·6-26·4) in the idelalisib group and 11·1 months (8·9-11·1) in the placebo group (hazard ratio [HR] 0·33, 95% CI 0·25-0·44; p<0·0001). The most frequent grade 3 or worse adverse events in the idelalisib group were neutropenia (124 [60%] of 207 patients) and febrile neutropenia (48 [23%]), whereas in the placebo group they were neutropenia (99 [47%] of 209) and thrombocytopenia (27 [13%]). An increased risk of infection was reported in the idelalisib group compared with the placebo group (grade ≥3 infections and infestations: 80 [39%] of 207 vs 52 [25%] of 209). Serious adverse events, including febrile neutropenia, pneumonia, and pyrexia, were more common in the idelalisib group (140 [68%] of 207 patients) than in the placebo group (92 [44%] of 209). Treatment-emergent adverse events leading to death occurred in 23 (11%) patients in the idelalisib group and 15 (7%) in the placebo group, including six deaths from infections in the idelalisib group and three from infections in the placebo group.
INTERPRETATION
Idelalisib in combination with bendamustine plus rituximab improved progression-free survival compared with bendamustine plus rituximab alone in patients with relapsed or refractory chronic lymphocytic leukaemia. However, careful attention needs to be paid to management of serious adverse events and infections associated with this regimen during treatment selection.
FUNDING
Gilead Sciences Inc.",2017,"Serious adverse events, including febrile neutropenia, pneumonia, and pyrexia, were more common in the idelalisib group (140 [68%] of 207 patients) than in the placebo group (92 [44%] of 209).","['adult patients (≥18 years) with relapsed or refractory chronic lymphocytic leukaemia requiring treatment who had measurable lymphadenopathy by CT or MRI and disease progression within 36 months since their last previous therapy were enrolled', 'Between June 26, 2012, and Aug 21, 2014, 416 patients', 'patients with relapsed or refractory chronic lymphocytic leukaemia']","['Bendamustine plus rituximab', 'bendamustine plus rituximab', 'placebo', 'bendamustine and rituximab', 'idelalisib', 'central interactive web response system to receive bendamustine plus rituximab for a maximum of six cycles (bendamustine: 70 mg/m 2 intravenously on days 1 and 2 for six 28-day cycles; rituximab', 'Idelalisib or placebo']","['febrile neutropenia', 'death', 'median progression-free survival', 'adverse events', 'progression-free survival', 'febrile neutropenia, pneumonia, and pyrexia', 'neutropenia', 'efficacy and safety', 'risk of infection', 'six deaths from infections', 'thrombocytopenia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0497156', 'cui_str': 'Adenopathy'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2698692', 'cui_str': 'idelalisib'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",416.0,0.729882,"Serious adverse events, including febrile neutropenia, pneumonia, and pyrexia, were more common in the idelalisib group (140 [68%] of 207 patients) than in the placebo group (92 [44%] of 209).","[{'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': 'Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: zeleneta@mskcc.org.'}, {'ForeName': 'Jacqueline C', 'Initials': 'JC', 'LastName': 'Barrientos', 'Affiliation': 'Hofstra Northwell School of Medicine, Hofstra University, New Hyde Park, NY, USA.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Brown', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Coiffier', 'Affiliation': 'Department of Haematology, Centre Hospitalier Lyon Sud, Pierre-Bénite, France.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Delgado', 'Affiliation': 'Department of Haematology, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Miklós', 'Initials': 'M', 'LastName': 'Egyed', 'Affiliation': 'Department of Haematology, Somogy County Kaposi Mór Hospital, Kaposvar, Hungary.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Division of Experimental Oncology and Department of Onco-Haematology, IRCCS Ospedale San Raffaele and Università Vita-Salute San Raffaele, Milan, Italy.'}, {'ForeName': 'Árpád', 'Initials': 'Á', 'LastName': 'Illés', 'Affiliation': 'Department of Haematology, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Jurczak', 'Affiliation': 'Department of Haematology, Jagiellonian University, Krakow, Poland.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Marlton', 'Affiliation': 'Department of Haematology, Princess Alexandra Hospital, University of Queensland, School of Medicine, Brisbane, Australia.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Montillo', 'Affiliation': 'Department of Haematology, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morschhauser', 'Affiliation': 'CHRU Lille, Unité GRITA, Department of Haematology, Université de Lille, Lille, France.'}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Pristupa', 'Affiliation': 'Department of Haematology, Ryazan Regional Clinical Hospital, Ryazan, Russia.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Department of Haematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Poland.'}, {'ForeName': 'Jeff P', 'Initials': 'JP', 'LastName': 'Sharman', 'Affiliation': 'US Oncology Research, Willamette Valley Cancer Institute and Research Center, Eugene, OR, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': 'North Shore Hospital, Takapuna, Auckland, New Zealand.'}, {'ForeName': 'Lukáš', 'Initials': 'L', 'LastName': 'Smolej', 'Affiliation': '4th Department of Internal Medicine-Haematology, University Hospital and Charles University in Prague, Faculty of Medicine in Hradec Králové, Hradec Králové, Czech Republic.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Adeboye H', 'Initials': 'AH', 'LastName': 'Adewoye', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Lyndah K', 'Initials': 'LK', 'LastName': 'Dreiling', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Yeonhee', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""Department of Haematology/Oncology, St James's University Hospital, Leeds, UK.""}]",The Lancet. Oncology,['10.1016/S1470-2045(16)30671-4']
782,31905383,"Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study.","BACKGROUND
The 2-drug regimen dolutegravir (DTG) + lamivudine (3TC) is indicated for treatment-naive adults with human immunodeficiency virus type 1 (HIV-1). We present efficacy and safety of switching to DTG/3TC in virologically suppressed individuals.
METHODS
TANGO is an open-label, multicenter, phase 3 study that randomized adults (1:1, stratified by baseline third agent class) with HIV-1 RNA <50 copies/mL to switch to once-daily fixed-dose DTG/3TC or remain on a tenofovir alafenamide (TAF)-based regimen. The primary end point was proportion of participants with HIV-1 RNA ≥50 copies/mL at week 48 (US Food and Drug Administration Snapshot algorithm) in the intention-to-treat-exposed population (4% noninferiority margin).
RESULTS
743 adults were enrolled; 741 received ≥1 dose of study drug (DTG/3TC, N = 369; TAF-based regimen, N = 372). At week 48, proportion of participants with HIV-1 RNA ≥50 copies/mL receiving DTG/3TC was 0.3% (1/369) vs 0.5% (2/372) with a TAF-based regimen (adjusted treatment difference [95% confidence interval], -0.3 [-1.2 to .7]), meeting noninferiority criteria. No participants receiving DTG/3TC and 1 receiving a TAF-based regimen met confirmed virologic withdrawal criteria, with no emergent resistance at failure. Drug-related grade ≥2 adverse events and withdrawals due to adverse events occurred in 17 (4.6%) and 13 (3.5%) participants with DTG/3TC and 3 (0.8%) and 2 (0.5%) with a TAF-based regimen, respectively.
CONCLUSIONS
DTG/3TC was noninferior in maintaining virologic suppression vs a TAF-based regimen at week 48, with no virologic failure or emergent resistance reported with DTG/3TC, supporting it as a simplification strategy for virologically suppressed people with HIV-1.
CLINICAL TRIALS REGISTRATION
NCT03446573.",2020,"At Week 48, proportion of participants with HIV-1 RNA ≥50 copies/mL treated with DTG/3TC was 0.3% (1/369) vs 0.5% (2/372) with a TAF-based regimen (adjusted treatment difference [95% CI], -0.3 [","['naive adults with HIV-1', 'virologically suppressed individuals', '743 adults were enrolled and 741 received ≥1 dose of study drug (DTG/3TC, N=369; TAF-based regimen, N=372', 'Adults']","['2-drug regimen (2DR) dolutegravir (DTG) + lamivudine (3TC', 'HIV-1', 'Fixed-Dose Two-Drug Regimen', 'HIV-1 RNA <50 copies/mL to switch to a once-daily DTG/3TC fixed-dose combination or remain on a tenofovir alafenamide (TAF)-based regimen', 'Tenofovir Alafenamide-Based Three- or Four-Drug Regimen', 'Switching to Dolutegravir/Lamivudine', 'DTG/3TC']","['virologic withdrawal criteria', 'Efficacy and Safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",743.0,0.17917,"At Week 48, proportion of participants with HIV-1 RNA ≥50 copies/mL treated with DTG/3TC was 0.3% (1/369) vs 0.5% (2/372) with a TAF-based regimen (adjusted treatment difference [95% CI], -0.3 [","[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'van Wyk', 'Affiliation': 'ViiV Healthcare, Brentford, United Kingdom.'}, {'ForeName': 'Faïza', 'Initials': 'F', 'LastName': 'Ajana', 'Affiliation': 'Centre Hospitalier de Tourcoing, Tourcoing, France.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Bisshop', 'Affiliation': 'Holdsworth House Medical Brisbane, Queensland, Australia.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'De Wit', 'Affiliation': 'CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Olayemi', 'Initials': 'O', 'LastName': 'Osiyemi', 'Affiliation': 'Triple O Research Institute PA, West Palm Beach, Florida, USA.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Portilla Sogorb', 'Affiliation': 'Hospital General Universitario de Alicante, Alicante, Spain.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Routy', 'Affiliation': 'McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wyen', 'Affiliation': 'Praxis am Ebertplatz, Cologne, Germany.'}, {'ForeName': 'Mounir', 'Initials': 'M', 'LastName': 'Ait-Khaled', 'Affiliation': 'ViiV Healthcare, Brentford, United Kingdom.'}, {'ForeName': 'Maria Claudia', 'Initials': 'MC', 'LastName': 'Nascimento', 'Affiliation': 'ViiV Healthcare, Brentford, United Kingdom.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Pappa', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Ruolan', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'GlaxoSmithKline, Stockley Park, United Kingdom.'}, {'ForeName': 'Allan R', 'Initials': 'AR', 'LastName': 'Tenorio', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Wynne', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aboud', 'Affiliation': 'ViiV Healthcare, Brentford, United Kingdom.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Gartland', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Smith', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, North Carolina, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1243']
783,26908742,A 12-Month-Interval Dosing Study in Adults Indicates That a Single Dose of the National Institute of Allergy and Infectious Diseases Tetravalent Dengue Vaccine Induces a Robust Neutralizing Antibody Response.,"UNLABELLED
The ideal dengue vaccine will provide protection against all serotypes of dengue virus and will be economical and uncomplicated in its administration. To determine the ability of a single dose of the live attenuated tetravalent dengue vaccine TV003 to induce a suitable neutralizing antibody response, a placebo-controlled clinical trial was performed in 48 healthy adults who received 2 doses of vaccine or placebo administered 12 months apart. Evaluation of safety, vaccine viremia, and neutralizing antibody response after each dose indicated that the first dose of vaccine was capable of preventing infection with the second dose, thus indicating that multiple doses are unnecessary.
CLINICAL TRIALS REGISTRATION
NCT01782300.",2016,"Evaluation of safety, vaccine viremia, and neutralizing antibody response after each dose indicated that the first dose of vaccine was capable of preventing infection with the second dose, thus indicating that multiple doses are unnecessary.
",['48 healthy adults who received 2 doses of'],"['vaccine or placebo', 'placebo']","['safety, vaccine viremia, and neutralizing antibody response']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}]",48.0,0.164951,"Evaluation of safety, vaccine viremia, and neutralizing antibody response after each dose indicated that the first dose of vaccine was capable of preventing infection with the second dose, thus indicating that multiple doses are unnecessary.
","[{'ForeName': 'Anna P', 'Initials': 'AP', 'LastName': 'Durbin', 'Affiliation': 'Center for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Pierce', 'Affiliation': 'Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Marya P', 'Initials': 'MP', 'LastName': 'Carmolli', 'Affiliation': 'Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Cecilia M', 'Initials': 'CM', 'LastName': 'Tibery', 'Affiliation': 'Center for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.'}, {'ForeName': 'Palmtama L', 'Initials': 'PL', 'LastName': 'Grier', 'Affiliation': 'Center for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.'}, {'ForeName': 'Noreen', 'Initials': 'N', 'LastName': 'Hynes', 'Affiliation': 'Center for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Opert', 'Affiliation': 'Center for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.'}, {'ForeName': 'Adrienne P', 'Initials': 'AP', 'LastName': 'Jarvis', 'Affiliation': 'Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Beulah P', 'Initials': 'BP', 'LastName': 'Sabundayo', 'Affiliation': 'Center for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'McElvany', 'Affiliation': 'Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Eli A', 'Initials': 'EA', 'LastName': 'Sendra', 'Affiliation': 'Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Larsson', 'Affiliation': 'Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jo', 'Affiliation': 'Center for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.'}, {'ForeName': 'Janece M', 'Initials': 'JM', 'LastName': 'Lovchik', 'Affiliation': 'Center for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Luke', 'Affiliation': 'Laboratory of Infectious Diseases, National Institutes of Allergy and Infectious Diseases, Bethesda, Maryland.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Walsh', 'Affiliation': 'Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Ellen A', 'Initials': 'EA', 'LastName': 'Fraser', 'Affiliation': 'Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Kanta', 'Initials': 'K', 'LastName': 'Subbarao', 'Affiliation': 'Laboratory of Infectious Diseases, National Institutes of Allergy and Infectious Diseases, Bethesda, Maryland.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Whitehead', 'Affiliation': 'Laboratory of Infectious Diseases, National Institutes of Allergy and Infectious Diseases, Bethesda, Maryland.'}]",The Journal of infectious diseases,['10.1093/infdis/jiw067']
784,32414381,Results of caring and reaching for health (CARE): a cluster-randomized controlled trial assessing a worksite wellness intervention for child care staff.,"BACKGROUND
Child care workers are among the lowest paid US workers and experience a wide array of health concerns. The physical and mental demands of their job and the lack of employer-provided health-insurance increase health risks. The Caring and Reaching for Health (CARE) study evaluated a 6-month Healthy Lifestyles intervention targeting child care workers' physical activity (primary outcome), other health behaviors, and their workplace health environment.
METHODS
Eligible child care centers, defined as being in operation for at least 2 years and employing at least four staff, were enrolled into CARE's cluster-randomized trial. Centers and their child care staff were randomly assigned to either the Healthy Lifestyles (HL) intervention arm or the Healthy Finances (HF) attention control arm using a block randomization approach. Intervention components were delivered through in-person workshops, center-level displays, informational magazines, director coaching, electronic messaging, and an interactive website. Outcome measures were collected during center visits at baseline and immediately post-intervention by trained data collectors blinded to center arm assignment. Workers' physical activity was assessed with accelerometers, worn for 7 days. Secondary outcome measures included biometric assessments of health and fitness, web-based surveys about health behaviors, and an environmental audit of workplace supports for health. Multi-level linear mixed models assessed worker- and center-level changes in these outcomes.
RESULTS
Participants included 553 child care workers representing 56 centers (HL = 250 staff/28 centers, HF = 303 staff/28 centers). At 6 months, moderate-to-vigorous physical activity declined slightly in both arms (- 1.3 min/day, 95% CI: - 3.0, 0.3 in HL; - 1.9 min/day, 95% CI: - 3.3, - 0.5 in HF), but there was no significant group by time interaction. Several secondary outcomes for other health behaviors and workplace health environment showed improvements in favor of the intervention arm, yet differences did not remain statistically significant after adjustment for multiple comparisons.
CONCLUSIONS
While the Healthy Lifestyles intervention did not improve health behaviors or the workplace health environment, results confirmed the pressing need to focus on the health of child care workers. Future interventions should focus on prevalent health issues (e.g., weight, stress), include both high-tech and high-touch intervention strategies, and address work conditions or other social determinants of health (e.g. wages) as a means of improving the health of these essential workers.
TRIAL REGISTRATION
Care2BWell: Worksite Wellness for Child Care (NCT02381938).",2020,"CONCLUSIONS
While the Healthy Lifestyles intervention did not improve health behaviors or the workplace health environment","['Centers and their child care staff', ""Eligible child care centers, defined as being in operation for at least 2 years and employing at least four staff, were enrolled into CARE's cluster-randomized trial"", 'child care staff', 'Participants included 553 child care workers representing 56 centers (HL\u2009=\u2009250 staff/28 centers, HF\u2009=\u2009303 staff/28 centers']","[""Healthy Lifestyles intervention targeting child care workers' physical activity (primary outcome), other health behaviors, and their workplace health environment"", 'Healthy Lifestyles (HL) intervention arm or the Healthy Finances (HF) attention control arm using a block randomization approach', 'worksite wellness intervention']","['biometric assessments of health and fitness, web-based surveys about health behaviors, and an environmental audit of workplace supports for health', ""Workers' physical activity"", 'moderate-to-vigorous physical activity', 'health behaviors']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0376243', 'cui_str': 'finances'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.0874431,"CONCLUSIONS
While the Healthy Lifestyles intervention did not improve health behaviors or the workplace health environment","[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Linnan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB 7440, Chapel Hill, North Carolina, 27599-7440, USA. linnan@email.unc.edu.'}, {'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Vaughn', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Falon T', 'Initials': 'FT', 'LastName': 'Smith', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Westgate', 'Affiliation': 'Department of Biostatistics, College of Public Heath, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Hales', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Arandia', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB 7440, Chapel Hill, North Carolina, 27599-7440, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Neshteruk', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-00968-x']
785,31403944,Exercise Training in Amnestic Mild Cognitive Impairment: A One-Year Randomized Controlled Trial.,"BACKGROUND
The current evidence is inconclusive to support the benefits of aerobic exercise training (AET) for preventing neurocognitive decline in patients with amnestic mild cognitive impairment (aMCI).
OBJECTIVE
To examine the effect of a progressive, moderate-to-high intensity AET program on memory and executive function, brain volume, and cortical amyloid-β (Aβ) plaque deposition in aMCI patients.
METHODS
This is a proof-of-concept trial that randomized 70 aMCI patients to 12 months of AET or stretching and toning (SAT, active control) interventions. Primary neuropsychological outcomes were assessed by using the California Verbal Learning Test-second edition (CVLT-II) and the Delis-Kaplan Executive Function System (D-KEFS). Secondary outcomes were the global and hippocampal brain volumes and the mean cortical and precuneus Aβ deposition.
RESULTS
Baseline cognitive scores were similar between the groups. Memory and executive function performance improved over time but did not differ between the AET and SAT groups. Brain volume decreased and precuneus Aβ plaque deposition increased over time but did not differ between the groups. Cardiorespiratory fitness was significantly improved in the AET compared with SAT group. In amyloid positive patients, AET was associated with reduced hippocampal atrophy when compared with the SAT group.
CONCLUSION
The AET and SAT groups both showed evidence of slightly improved neuropsychological scores in previously sedentary aMCI patients. However, these interventions did not prevent brain atrophy or increases in cortical Aβ deposition over 12 months. In amyloid positive patients, AET reduced hippocampal atrophy when compared with the SAT group.",2019,Brain volume decreased and precuneus,"['aMCI patients', 'Amnestic Mild Cognitive Impairment', 'patients with amnestic mild cognitive impairment (aMCI']","['Exercise Training', 'aerobic exercise training (AET', 'AET or stretching and toning (SAT, active control) interventions']","['global and hippocampal brain volumes and the mean cortical and precuneus', 'reduced hippocampal atrophy', 'California Verbal Learning Test-second edition (CVLT-II) and the Delis-Kaplan Executive Function System (D-KEFS', 'memory and executive function, brain volume, and cortical amyloid-β (Aβ) plaque deposition', 'hippocampal atrophy', 'Memory and executive function performance', 'plaque deposition', 'neuropsychological scores', 'Cardiorespiratory fitness', 'cortical Aβ deposition', 'Brain volume decreased and precuneus']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0629582', 'cui_str': 'AETS'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0589055', 'cui_str': 'TOMAL'}, {'cui': 'C0441795', 'cui_str': 'Second edition (qualifier value)'}, {'cui': 'C4505413', 'cui_str': 'Delis-Kaplan Executive Function System'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",70.0,0.124384,Brain volume decreased and precuneus,"[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tarumi', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Rossetti', 'Affiliation': 'Departments of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Binu P', 'Initials': 'BP', 'LastName': 'Thomas', 'Affiliation': 'Departments of Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Harris', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Benjamin Y', 'Initials': 'BY', 'LastName': 'Tseng', 'Affiliation': 'Department of Health and Kinesiology, The University of Texas at Tyler, Tyler, TX, USA.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Turner', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Ciwen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'German', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Martin-Cook', 'Affiliation': 'Departments of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Stowe', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Kyle B', 'Initials': 'KB', 'LastName': 'Womack', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Mathews', 'Affiliation': 'Departments of Radiology, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Diana R', 'Initials': 'DR', 'LastName': 'Kerwin', 'Affiliation': ""Institute for Texas Alzheimer's and Memory Disorders, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hynan', 'Affiliation': 'Departments of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Diaz-Arrastia', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Hanzhang', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Departments of Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'C Munro', 'Initials': 'CM', 'LastName': 'Cullum', 'Affiliation': 'Departments of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-181175']
786,31907323,Cautionary study on the effects of pay for performance on quality of care: a pilot randomised controlled trial using standardised patients.,"BACKGROUND
Due to the difficulty of studying incentives in practice, there is limited empirical evidence of the full-impact pay-for-performance (P4P) incentive systems.
OBJECTIVE
To evaluate the impact of P4P in a controlled, simulated environment.
DESIGN
We employed a simulation-based randomised controlled trial with three standardised patients to assess advanced practice providers' performance. Each patient reflected one of the following: (A) indicated for P4P screenings, (B) too young for P4P screenings, or (C) indicated for P4P screenings, but screenings are unrelated to the reason for the visit. Indication was determined by the 2016 Centers for Medicare and Medicaid Services quality measures.
INTERVENTION
The P4P group was paid $150 and received a bonus of $10 for meeting each of five outcome measures (breast cancer, colorectal cancer, pneumococcal, tobacco use and depression screenings) for each of the three cases (max $300). The control group received $200.
SETTING
Learning resource centre.
PARTICIPANTS
35 advanced practice primary care providers (physician assistants and nurse practitioners) and 105 standardised patient encounters.
MEASUREMENTS
Adherence to incentivised outcome measures, interpersonal communication skills, standards of care, and misuse.
RESULTS
The Type a patient was more likely to receive indicated P4P screenings in the P4P group (3.82 out of 5 P4P vs 2.94 control, p=0.02), however, received lower overall standards of care under P4P (31.88 P4P vs 37.06 control, p=0.027). The Type b patient was more likely to be prescribed screenings not indicated, but highlighted by P4P: breast cancer screening (47% P4P vs 0% control, p<0.01) and colorectal cancer screening (24% P4P vs 0% control, p=0.03). The P4P group over-reported completion of incentivised measures resulting in overpayment (average of $9.02 per patient).
LIMITATIONS
A small sample size and limited variability in patient panel limit the generalisability of findings.
CONCLUSIONS
Our findings caution the adoption of P4P by highlighting the unintended consequences of the incentive system.",2020,"The Type a patient was more likely to receive indicated P4P screenings in the P4P group (3.82 out of 5 P4P vs 2.94 control, p=0.02), however, received lower overall standards of care under P4P (31.88 P4P vs 37.06 control, p=0.027).","[""three standardised patients to assess advanced practice providers' performance"", '35 advanced practice primary care providers (physician assistants and nurse practitioners) and 105 standardised patient encounters.\nMEASUREMENTS', 'Learning resource centre']",[],"['quality of care', 'P4P screenings', 'interpersonal communication skills, standards of care, and misuse', 'colorectal cancer screening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0031833', 'cui_str': ""Physicians' Extenders""}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],"[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]",35.0,0.114741,"The Type a patient was more likely to receive indicated P4P screenings in the P4P group (3.82 out of 5 P4P vs 2.94 control, p=0.02), however, received lower overall standards of care under P4P (31.88 P4P vs 37.06 control, p=0.027).","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Green', 'Affiliation': 'College of Health Solutions, Arizona State University, Tempe, Arizona, USA ellen.green@asu.edu.'}, {'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Peterson', 'Affiliation': 'Mayo Clinic Scottsdale, Scottsdale, Arizona, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Markiewicz', 'Affiliation': 'Mayo Clinic Scottsdale, Scottsdale, Arizona, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': ""O'Brien"", 'Affiliation': 'College of Health Solutions, Arizona State University, Tempe, Arizona, USA.'}, {'ForeName': 'Noel M', 'Initials': 'NM', 'LastName': 'Arring', 'Affiliation': 'Department of Systems, Population and Leadership, University of Michigan, Ann Arbor, Michigan, USA.'}]",BMJ quality & safety,['10.1136/bmjqs-2019-010260']
787,31566239,"Association of Tobacco Use During Pregnancy, Perceived Stress, and Depression Among Alaska Native Women Participants in the Healthy Pregnancies Project.","INTRODUCTION
In general population samples, higher levels of stress and depression have been associated with increased prevalence of smoking in pregnancy. Little is known about the association of prenatal tobacco use, stress, and depression among American Indian or Alaska Native (AI/AN) women.
METHODS
The Healthy Pregnancies Project is a cluster-randomized controlled trial, evaluating a community-level intervention compared with usual care, for reducing tobacco use during pregnancy and postpartum among AN women in 16 villages in western Alaska. This cross-sectional study analyzed baseline data from enrolled pregnant women. Baseline measures included the self-reported, 7-day, point-prevalence current use of any tobacco, Perceived Stress Scale (PSS), and the Center for Epidemiological Studies-Depression (CES-D). Generalized estimating equations (GEE) analyses adjusted for village, participant age, and gestational age.
RESULTS
Participants (N = 352) were on average (SD) 25.8 (5.0) years of age and at 26.8 (9.8) weeks gestation. 66.5% were current tobacco users, of which 77% used Iqmik, a homemade form of smokeless tobacco. Compared with nonusers, tobacco users reported lower PSS score (p = .020) and less clinical levels of depression (CES-D ≥ 16) (18.1% vs. 9.3%, p = .21). Findings were not accounted for by nicotine dependence severity or self-reported tobacco use before pregnancy.
CONCLUSIONS
In this sample of pregnant AN women, tobacco users report less stress and clinical levels of depression than nonusers. A potential challenge with tobacco treatment for pregnant AN women is to provide alternative ways of deescalating stress and affect management instead of using tobacco.
IMPLICATIONS
This study contributes novel information on the association of tobacco use, perceived stress, and depression among Alaska Native women enrolled in a clinical trial to promote healthy pregnancies. Most prior studies addressing this topic were conducted among general population samples of pregnant women who smoked cigarettes. Little is known about these associations with prenatal smokeless tobacco, or among American Indian or Alaska Native women. The results are contrary to findings reported previously, because current tobacco use was associated with less stress and depression than nonuse. The study findings have implications for cessation treatment for this tobacco-use disparity group.",2020,"Compared with non-users, tobacco users reported lower PSS score (p=0.020) and less clinical levels of depression (CES-D ≥16) (18.1% vs. 9.3%, p=0.21).","['Alaska Native Women Participants in the Healthy Pregnancies Project', 'during pregnancy and postpartum among AN women in 16 villages in western Alaska', 'pregnant AN women', 'American Indian or Alaska Native women', 'Alaska Native women enrolled in a clinical trial to promote healthy pregnancies', 'Participants (N=352) were on average (SD) 25.8 (5.0) years of age and at 26.8 (9.8) weeks gestation', 'enrolled pregnant women', 'pregnant women who smoked cigarettes', 'American Indian or Alaska Native (AI/AN) women']","['community-level intervention compared with usual care, for reducing tobacco use']","['PSS score', 'clinical levels of depression', 'stress and depression', 'self-reported, 7-day, point-prevalence current use of any tobacco, Perceived Stress Scale (PSS), and the Center for Epidemiological Studies-Depression (CES-D']","[{'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0001905', 'cui_str': 'Alaska'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C1515945', 'cui_str': 'American Indian or Alaska native (racial group)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0002783', 'cui_str': 'Epidemiological Studies'}]",,0.059071,"Compared with non-users, tobacco users reported lower PSS score (p=0.020) and less clinical levels of depression (CES-D ≥16) (18.1% vs. 9.3%, p=0.21).","[{'ForeName': 'Christi A', 'Initials': 'CA', 'LastName': 'Patten', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Harry A', 'Initials': 'HA', 'LastName': 'Lando', 'Affiliation': 'University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Desnoyers', 'Affiliation': 'Yukon-Kuskokwim Health Corporation, Bethel, AK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Klejka', 'Affiliation': 'Yukon-Kuskokwim Health Corporation, Bethel, AK.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Decker', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Bock', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Hughes', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Alexie', 'Affiliation': 'Yukon-Kuskokwim Health Corporation, Bethel, AK.'}, {'ForeName': 'Rahnia', 'Initials': 'R', 'LastName': 'Boyer', 'Affiliation': 'Yukon-Kuskokwim Health Corporation, Bethel, AK.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Burhansstipanov', 'Affiliation': 'Native American Cancer Initiatives, Inc., Pine, CO.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz189']
788,31561326,Feasibility of supplemental robot-assisted knee flexion exercise following total knee arthroplasty.,"BACKGROUND
The Hybrid Assistive Limb (HAL) is a robotic exoskeleton designed to support impaired limbs.
OBJECTIVE
We aimed to evaluate whether active exercise using a single-joint HAL (HAL-SJ) following total knee arthroplasty can facilitate the recovery of knee flexion.
METHODS
Twenty-two patients who underwent total knee arthroplasty were randomly allocated to the HAL-SJ group (n= 12) or conventional physical therapy (CPT) group (n= 10). On postoperative day 5, patients performed active knee flexion exercises either with or without HAL-SJ assistance every second day. Outcome measures included active and passive knee flexion range of motion (ROM), muscle strength, and pain intensity, as assessed by the visual analog scale, and were assessed on postoperative days 5 (pre-treatment) and 10 (post-treatment). Active ROM was measured at 6 months postoperatively; further long-term follow-up was performed by telephone interview.
RESULTS
Both groups showed significant improvement between postoperative days 5 and 10 in all outcome measures. Improvements in active ROM (p< 0.01), passive ROM (p< 0.01), muscle strength (p< 0.01), and pain (p< 0.01) were significantly greater in the HAL-SJ group than in the CPT group. Long-term outcomes were also significantly better in the HAL-SJ group.
CONCLUSIONS
HAL therapy enables patients to perform painless active movements and facilitates the recovery of knee function.",2020,"Improvements in active ROM (p< 0.01), passive ROM (p< 0.01), muscle strength (p< 0.01), and pain (p< 0.01) were significantly greater in the HAL-SJ group than in the CPT group.","['total knee arthroplasty', 'Twenty-two patients who underwent total knee arthroplasty']","['HAL-SJ', 'Hybrid Assistive Limb (HAL', 'active knee flexion exercises either with or without HAL-SJ assistance', 'supplemental robot-assisted knee flexion exercise', 'HAL therapy', 'conventional physical therapy (CPT', 'active exercise using a single-joint HAL (HAL-SJ', 'CPT']","['Active ROM', 'passive ROM', 'pain', 'active and passive knee flexion range of motion (ROM), muscle strength, and pain intensity, as assessed by the visual analog scale', 'muscle strength', 'active ROM']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0419117', 'cui_str': 'Active exercise (regime/therapy)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",22.0,0.0458674,"Improvements in active ROM (p< 0.01), passive ROM (p< 0.01), muscle strength (p< 0.01), and pain (p< 0.01) were significantly greater in the HAL-SJ group than in the CPT group.","[{'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Kotani', 'Affiliation': 'Department of Neurosurgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Morishita', 'Affiliation': 'Department of Neurosurgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Saita', 'Affiliation': 'Department of Neurosurgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kamada', 'Affiliation': 'Department of Rehabilitation Medicine, Fukuoka University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Maeyama', 'Affiliation': 'Department of Orthopedic Surgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Abe', 'Affiliation': 'Department of Neurosurgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Takuaki', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Orthopedic Surgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Etsuji', 'Initials': 'E', 'LastName': 'Shiota', 'Affiliation': 'Department of Rehabilitation Medicine, Fukuoka University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Tooru', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Neurosurgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181482']
789,31873098,Characterizing the temporal Dynamics of Melatonin and Cortisol Changes in Response to Nocturnal Light Exposure.,"We studied the dynamics of melatonin suppression and changes in cortisol levels in humans in response to light exposure at night using high-frequency blood sampling. Twenty-one young healthy participants were randomized to receive either intermittent bright (~9,500 lux) light (IBL), continuous bright light (CBL) or continuous dim (~1 lux) light (VDL) for 6.5 h during the biological night (n = 7 per condition). Melatonin suppression occurred rapidly within the first 5 min and continued until the end of each IBL stimuli (t 1/2 = ~13 min). Melatonin recovery occurred more slowly between IBL stimuli (half-maximal recovery rate of ~46 min). Mean melatonin suppression (~40%) and recovery (~50%) were similar across IBL stimuli. Suppression dynamics under CBL were also rapid (t 1/2 = ~18 min), with no recovery until the light exposure ended. There was a significant linear increase of cortisol levels between the start and end of each IBL stimulus. Under CBL conditions cortisol showed trimodal changes with an initial linear activating phase, followed by an exponential inhibitory phase, and a final exponential recovery phase. These results show that light exposure at night affects circadian driven hormones differently and that outcomes are influenced by the duration and pattern of light exposure.",2019,Mean melatonin suppression (~40%) and recovery (~50%) were similar across IBL stimuli.,"['Twenty-one young healthy participants', 'humans in response to light exposure at night using high-frequency blood sampling']","['intermittent bright (~9,500\u2009lux) light (IBL), continuous bright light (CBL) or continuous dim (~1\u2009lux) light (VDL']","['Melatonin suppression', 'Melatonin recovery', 'cortisol levels', 'Mean melatonin suppression']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0423899', 'cui_str': 'Gifted (observable entity)'}, {'cui': 'C0560137', 'cui_str': 'lux (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",21.0,0.0173523,Mean melatonin suppression (~40%) and recovery (~50%) were similar across IBL stimuli.,"[{'ForeName': 'Shadab A', 'Initials': 'SA', 'LastName': 'Rahman', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital, Boston, MA, USA. sarahman@rics.bwh.harvard.edu.""}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Wright', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Czeisler', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Gronfier', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital, Boston, MA, USA.""}]",Scientific reports,['10.1038/s41598-019-54806-7']
790,27838347,"Features of the bronchial bacterial microbiome associated with atopy, asthma, and responsiveness to inhaled corticosteroid treatment.","BACKGROUND
Compositional differences in the bronchial bacterial microbiota have been associated with asthma, but it remains unclear whether the findings are attributable to asthma, to aeroallergen sensitization, or to inhaled corticosteroid treatment.
OBJECTIVES
We sought to compare the bronchial bacterial microbiota in adults with steroid-naive atopic asthma, subjects with atopy but no asthma, and nonatopic healthy control subjects and to determine relationships of the bronchial microbiota to phenotypic features of asthma.
METHODS
Bacterial communities in protected bronchial brushings from 42 atopic asthmatic subjects, 21 subjects with atopy but no asthma, and 21 healthy control subjects were profiled by using 16S rRNA gene sequencing. Bacterial composition and community-level functions inferred from sequence profiles were analyzed for between-group differences. Associations with clinical and inflammatory variables were examined, including markers of type 2-related inflammation and change in airway hyperresponsiveness after 6 weeks of fluticasone treatment.
RESULTS
The bronchial microbiome differed significantly among the 3 groups. Asthmatic subjects were uniquely enriched in members of the Haemophilus, Neisseria, Fusobacterium, and Porphyromonas species and the Sphingomonodaceae family and depleted in members of the Mogibacteriaceae family and Lactobacillales order. Asthma-associated differences in predicted bacterial functions included involvement of amino acid and short-chain fatty acid metabolism pathways. Subjects with type 2-high asthma harbored significantly lower bronchial bacterial burden. Distinct changes in specific microbiota members were seen after fluticasone treatment. Steroid responsiveness was linked to differences in baseline compositional and functional features of the bacterial microbiome.
CONCLUSION
Even in subjects with mild steroid-naive asthma, differences in the bronchial microbiome are associated with immunologic and clinical features of the disease. The specific differences identified suggest possible microbiome targets for future approaches to asthma treatment or prevention.",2017,"Asthmatic subjects were uniquely enriched in members of the Haemophilus, Neisseria, Fusobacterium, and Porphyromonas species and the Sphingomonodaceae family and depleted in members of the Mogibacteriaceae family and Lactobacillales order.","['Asthmatic subjects were uniquely enriched in members of the Haemophilus, Neisseria, Fusobacterium, and Porphyromonas species and the Sphingomonodaceae family and depleted in members of the Mogibacteriaceae family and Lactobacillales order', 'Bacterial communities in protected bronchial brushings from 42 atopic asthmatic subjects, 21 subjects with atopy but no asthma, and 21 healthy control subjects were profiled by using 16S rRNA gene sequencing', 'Subjects with type 2-high asthma', 'adults with steroid-naive atopic asthma, subjects with atopy but no asthma, and nonatopic healthy control subjects', 'subjects with mild steroid-naive asthma']",['fluticasone'],"['Steroid responsiveness', 'airway hyperresponsiveness', 'bronchial bacterial burden', 'bronchial microbiome', 'bronchial bacterial microbiota', 'Bacterial composition and community-level functions']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0018479', 'cui_str': 'Hemophilus'}, {'cui': 'C0027571', 'cui_str': 'Neisseria'}, {'cui': 'C0016878', 'cui_str': 'Sphaerophorus'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205039', 'cui_str': 'Bronchial (qualifier value)'}, {'cui': 'C0392707', 'cui_str': 'Atopy (disorder)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035899', 'cui_str': 'Ribosomal RNA Genes'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma (disorder)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}]","[{'cui': 'C0082607', 'cui_str': 'fluticasone'}]","[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0205039', 'cui_str': 'Bronchial (qualifier value)'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",42.0,0.0200773,"Asthmatic subjects were uniquely enriched in members of the Haemophilus, Neisseria, Fusobacterium, and Porphyromonas species and the Sphingomonodaceae family and depleted in members of the Mogibacteriaceae family and Lactobacillales order.","[{'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Durack', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, University of California, San Francisco, Calif.'}, {'ForeName': 'Susan V', 'Initials': 'SV', 'LastName': 'Lynch', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, University of California, San Francisco, Calif.'}, {'ForeName': 'Snehal', 'Initials': 'S', 'LastName': 'Nariya', 'Affiliation': 'Division of Pulmonary & Critical Care Medicine, University of Michigan, Ann Arbor, Mich.'}, {'ForeName': 'Nirav R', 'Initials': 'NR', 'LastName': 'Bhakta', 'Affiliation': 'Department of Medicine, University of California, San Francisco, Calif.'}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Beigelman', 'Affiliation': 'Division of Pediatrics, Washington University School of Medicine, St Louis, Mo.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Division of Pediatrics, Washington University School of Medicine, St Louis, Mo; Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St Louis, Mo.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Dyer', 'Affiliation': 'Department of Public Health Sciences, Penn State University, Hershey, Pa.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Department of Medicine, Brigham & Women's Hospital, Boston, Mass.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kraft', 'Affiliation': 'Health Sciences, University of Arizona, Tucson, Ariz.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Martin', 'Affiliation': 'Department of Medicine, National Jewish Hospital, Denver, Colo.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Mauger', 'Affiliation': 'Department of Public Health Sciences, Penn State University, Hershey, Pa.'}, {'ForeName': 'Sharon R', 'Initials': 'SR', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Medicine, Northwestern University, Chicago, Ill.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Sharp-King', 'Affiliation': 'Department of Public Health Sciences, Penn State University, Hershey, Pa.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'White', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, Ill.'}, {'ForeName': 'Prescott G', 'Initials': 'PG', 'LastName': 'Woodruff', 'Affiliation': 'Department of Medicine, University of California, San Francisco, Calif.'}, {'ForeName': 'Pedro C', 'Initials': 'PC', 'LastName': 'Avila', 'Affiliation': 'Department of Medicine, Northwestern University, Chicago, Ill.'}, {'ForeName': 'Loren C', 'Initials': 'LC', 'LastName': 'Denlinger', 'Affiliation': 'Department of Medicine, University of Wisconsin-Madison, Madison, Wis.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Holguin', 'Affiliation': 'University of Pittsburgh Asthma Institute at UPMC/UPSOM, Pittsburgh, Pa.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Lazarus', 'Affiliation': 'Department of Medicine, University of California, San Francisco, Calif.'}, {'ForeName': 'Njira', 'Initials': 'N', 'LastName': 'Lugogo', 'Affiliation': 'Duke Asthma, Allergy & Airway Center, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Moore', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Peters', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Que', 'Affiliation': 'Duke Asthma, Allergy & Airway Center, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, Northwestern University, Chicago, Ill.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Sorkness', 'Affiliation': 'Department of Medicine, University of Wisconsin-Madison, Madison, Wis.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'Department of Medicine, National Jewish Hospital, Denver, Colo.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Wenzel', 'Affiliation': 'University of Pittsburgh Asthma Institute at UPMC/UPSOM, Pittsburgh, Pa.'}, {'ForeName': 'Homer A', 'Initials': 'HA', 'LastName': 'Boushey', 'Affiliation': 'Department of Medicine, University of California, San Francisco, Calif. Electronic address: homer.boushey@ucsf.edu.'}, {'ForeName': 'Yvonne J', 'Initials': 'YJ', 'LastName': 'Huang', 'Affiliation': 'Division of Pulmonary & Critical Care Medicine, University of Michigan, Ann Arbor, Mich.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2016.08.055']
791,31907662,Comparison of indocyanine green and carbon nanoparticles in endoscopic techniques for central lymph nodes dissection in patients with papillary thyroid cancer.,"BACKGROUND
Injection of carbon nanoparticle (CN) into the thyroid gland is used to stain CLNs in endoscopic surgery of patients with papillary thyroid cancer (PTC). The black-dye technique facilitates the central lymph nodes (CLNs) harvest and parathyroid protection, but improper handling of CN during injection leads to unwanted staining of surrounding tissues and increases the difficulty in anatomical identification. Therefore, a new method is needed to overcome this problem.
METHODS
Forty-eight patients with PTC underwent endoscopic thyroidectomy via breast approach. Patients were randomized into the indocyanine green (ICG) group (Group ICG; n = 23) and CN group (Group CN; n = 25). After thyroid gland exposure, ICG was injected into the thyroid lobes. Fluorescent CLNs were identified and dissected in Group ICG. In Group CN, CN was used instead. Black dyed CLNs were harvested. The following was compared between groups: demographic characteristics, surgical time, drainage amount, hospital stay duration, number of CLNs harvested, frequency of postoperative hoarseness and hypothyroidism, and surgical cost.
RESULTS
Group ICG showed decreased hypoparathyroidism frequency than Group CN (1/23 vs. 7/25, p = 0.028) and more harvested CLNs (4.6 ± 1.0 vs. 3.8 ± 1.2, p = 0.020). There was no difference between drainage amount, hospital stay duration, and frequency of postoperative hoarseness. The cost of Group ICG was less than that of Group CN (p = 0).
CONCLUSION
Injection of ICG into the thyroid gland using fluorescence imaging in endoscopic surgery in patients with PTC is safer and more effective in identifying CLNs than injection with CN. This novel method can lead to improved identification and subsequent harvesting of CLNs.",2020,"There was no difference between drainage amount, hospital stay duration, and frequency of postoperative hoarseness.","['patients with PTC', 'patients with papillary thyroid cancer (PTC', 'Forty-eight patients with PTC underwent', 'patients with papillary thyroid cancer']","['endoscopic thyroidectomy via breast approach', 'ICG', 'indocyanine green (ICG) group (Group ICG; n\u2009=\u200923) and CN', 'indocyanine green and carbon nanoparticles', 'carbon nanoparticle (CN']","['hypoparathyroidism frequency', 'drainage amount, hospital stay duration, and frequency of postoperative hoarseness', 'demographic characteristics, surgical time, drainage amount, hospital stay duration, number of CLNs harvested, frequency of postoperative hoarseness and hypothyroidism, and surgical cost']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015491', 'cui_str': 'factor IX'}, {'cui': 'C0238463', 'cui_str': 'Thyroid Cancer, Papillary'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}]","[{'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}]","[{'cui': 'C0020626', 'cui_str': 'Hypoparathyroidism'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2609422', 'cui_str': 'Hypothyroidism (SMQ)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",48.0,0.0219087,"There was no difference between drainage amount, hospital stay duration, and frequency of postoperative hoarseness.","[{'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Breast Surgery, Yinzhou Hospital of Ningbo University Medical College, Ningbo, 315040, Zhejiang, China.'}, {'ForeName': 'Jia-Gen', 'Initials': 'JG', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid and Breast Surgery, Yinzhou Hospital of Ningbo University Medical College, Ningbo, 315040, Zhejiang, China. zmz78121@126.com.'}, {'ForeName': 'Song-Ze', 'Initials': 'SZ', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Breast Surgery, Yinzhou Hospital of Ningbo University Medical College, Ningbo, 315040, Zhejiang, China.'}, {'ForeName': 'Gun', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Pathology, Yinzhou Hospital of Ningbo University Medical College, Ningbo, Zhejiang, China.'}]",Surgical endoscopy,['10.1007/s00464-019-07326-4']
792,31874985,Neural and behavioral changes driven by observationally-induced hypoalgesia.,"Observing successful pain treatment in others can induce anticipatory neural processes that, in turn, relieve pain. Previous studies have suggested that social learning and observation influence placebo hypoalgesia. Here, we used electroencephalography (EEG) to determine the neurophysiological changes associated with pain relief acquired through the observation. Thirty-one participants observed a demonstrator undergo painful heat stimulations paired with a ""control"" cream and non-painful ones paired with a ""treatment"" cream, which actually were both Vanicreams. After their observation, the participants then received the same creams and stimulations. We found that the treatment cream led to lower self-reported pain intensity ratings than the control cream. Anticipatory treatment cues elicited smaller P2 in electrodes F1, Fz, FC1, and FCz than the control condition. The P2 component localization indicated a higher current density in the right middle frontal gyrus, a region associated with attentional engagement. In placebo responders, the sensorimotor cortex activity captured in electrodes C3, Cz, and C4 indicated that hypoalgesia was positively correlated with resting state peak alpha frequency (PAF). These results suggest that observationally-induced placebo hypoalgesia may be driven by anticipatory mechanisms that modulate frontal attentional processes. Furthermore, resting state PAF could serve as a predictor of observationally-induced hypoalgesia.",2019,"Anticipatory treatment cues elicited smaller P2 in electrodes F1, Fz, FC1, and FCz than the control condition.",[],"['control"" cream and non-painful ones paired with a ""treatment"" cream']","['resting state peak alpha frequency (PAF', 'pain intensity ratings', 'sensorimotor cortex activity', 'electrodes F1, Fz, FC1, and FCz']",[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3499125', 'cui_str': 'Sensory Motor Cortex'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",31.0,0.0375226,"Anticipatory treatment cues elicited smaller P2 in electrodes F1, Fz, FC1, and FCz than the control condition.","[{'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Raghuraman', 'Affiliation': 'Department of Pain and Translational Symptom Sciences University of Maryland School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pain and Translational Symptom Sciences University of Maryland School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Lieven A', 'Initials': 'LA', 'LastName': 'Schenk', 'Affiliation': 'Social Neuroscience Lab, Max Planck Society, Berlin, Germany.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Furman', 'Affiliation': 'Department of Neural Pain Sciences University of Maryland School of Dentistry, Baltimore, MD, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tricou', 'Affiliation': 'Department of Neural Pain Sciences University of Maryland School of Dentistry, Baltimore, MD, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Seminowicz', 'Affiliation': 'Department of Neural Pain Sciences University of Maryland School of Dentistry, Baltimore, MD, USA.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain and Translational Symptom Sciences University of Maryland School of Nursing, Baltimore, MD, USA. colloca@umaryland.edu.'}]",Scientific reports,['10.1038/s41598-019-56188-2']
793,27222459,"The effectiveness of manual-guided, problem-solving-based self-learning programme for family caregivers of people with recent-onset psychosis: A randomised controlled trial with 6-month follow-up.","BACKGROUND
Family intervention for psychotic disorders is an integral part of psychiatric treatment with positive effects on patients' mental state and relapse rate. However, the effect of such family-based intervention on caregivers' psychological distress and well-being, especially in non-Western countries, has received comparatively much less attention.
OBJECTIVES
To test the effects of guided problem-solving-based manual-guided self-learning programme for family caregivers of adults with recent-onset psychosis over a 6-month period of follow-up, when compared with those in usual family support service.
DESIGN
A single-centre randomised controlled trial, which was registered at ClinicalTrials.gov (NCT02391649), with a repeated-measures, two-arm (parallel-group) design.
SETTINGS
One main psychiatric outpatient clinic in the New Territories of Hong Kong.
PARTICIPANTS
A random sample of 116 family caregiverss of adult outpatients with recent-onset psychosis.
METHODS
Following pre-test measurement, caregivers were assigned randomly to one of two study groups: a 5-month self-help, problem-solving-based manual-guided self-learning (or bibliotherapy) programme (in addition to usual care), or usual family support service only. Varieties of patient and caregiver health outcomes were assessed and compared at baseline and at 1-week and 6-month post-intervention.
RESULTS
One hundred and eleven (96%) caregivers completed the 6-month follow-up (two post-tests); 55 of them (95%) completed ≥4 modules and attended ≥2 review sessions (i.e., 75% of the intervention). The family participants' mean age was about 38 years and over 64% of them were female and patient's parent or spouse. Multivariate analyses of variance indicated that the manual-guided self-learning group reported significantly greater improvements than the usual care group in family burden [F(1,110)=6.21, p=0.006] and caregiving experience [F(1,110)=6.88, p=0.0004], and patients' psychotic symptoms [F(1,110)=6.25, p=0.0003], functioning [F(1,110)=7.01, p=0.0005] and number of hospitalisations [F(1,110)=5.71, p=0.005] over 6-month follow-up.
CONCLUSIONS
Problem-solving-based, manual-guided self-learning programme for family caregivers of adults with recent-onset psychosis can be an effective self-help programme and provide medium-term benefits to patients' and caregivers' mental health and duration of patients' re-hospitalisations.",2016,"Multivariate analyses of variance indicated that the manual-guided self-learning group reported significantly greater improvements than the usual care group in family burden [F(1,110)=6.21, p=0.006] and caregiving experience [F(1,110)=6.88, p=0.0004], and patients' psychotic symptoms [F(1,110)=6.25, p=0.0003], functioning [F(1,110)=7.01, p=0.0005] and number of hospitalisations [F(1,110)=5.71, p=0.005] over 6-month follow-up.
","['family caregivers of adults with recent-onset psychosis', 'family caregivers of adults with recent-onset psychosis over a 6-month period of follow-up, when compared with those in usual family support service', 'One main psychiatric outpatient clinic in the New Territories of Hong Kong', 'family caregivers of people with recent-onset psychosis', 'One hundred and eleven (96%) caregivers completed the 6-month follow-up (two post-tests); 55 of them (95%) completed ≥4 modules and attended ≥2 review sessions (i.e., 75% of the intervention', ""The family participants' mean age was about 38 years and over 64% of them were female and patient's parent or spouse"", 'A random sample of 116 family caregiverss of adult outpatients with recent-onset psychosis']","['guided problem-solving-based manual-guided self-learning programme', 'manual-guided, problem-solving-based self-learning programme', '5-month self-help, problem-solving-based manual-guided self-learning (or bibliotherapy) programme (in addition to usual care), or usual family support service only', 'Problem-solving-based, manual-guided self-learning programme']","[""patients' psychotic symptoms"", 'caregiving experience', ""caregivers' psychological distress"", 'number of hospitalisations']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0150232', 'cui_str': 'Family support (regime/therapy)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0524613', 'cui_str': 'New Territories'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3874886', 'cui_str': 'Is about (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0162409', 'cui_str': 'Married Persons'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0005365', 'cui_str': 'Bibliotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0150232', 'cui_str': 'Family support (regime/therapy)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",116.0,0.0983606,"Multivariate analyses of variance indicated that the manual-guided self-learning group reported significantly greater improvements than the usual care group in family burden [F(1,110)=6.21, p=0.006] and caregiving experience [F(1,110)=6.88, p=0.0004], and patients' psychotic symptoms [F(1,110)=6.25, p=0.0003], functioning [F(1,110)=7.01, p=0.0005] and number of hospitalisations [F(1,110)=5.71, p=0.005] over 6-month follow-up.
","[{'ForeName': 'Wai Tong', 'Initials': 'WT', 'LastName': 'Chien', 'Affiliation': 'School of Nursing, Faculty of Health and Social Sciences, The Hong Kong Polytechnic University, Hong Kong Special Administrative Region. Electronic address: wai.tong.chien@polyu.edu.hk.'}, {'ForeName': 'Annie L K', 'Initials': 'AL', 'LastName': 'Yip', 'Affiliation': 'School of Nursing, Faculty of Health and Social Sciences, The Hong Kong Polytechnic University, Hong Kong Special Administrative Region. Electronic address: annie.l.k.yip@polyu.edu.hk.'}, {'ForeName': 'Justina Y W', 'Initials': 'JY', 'LastName': 'Liu', 'Affiliation': 'School of Nursing, Faculty of Health and Social Sciences, The Hong Kong Polytechnic University, Hong Kong Special Administrative Region. Electronic address: justina.liu@polyu.edu.hk.'}, {'ForeName': 'Terry W', 'Initials': 'TW', 'LastName': 'McMaster', 'Affiliation': 'Department of Psychiatry, University of Alberta, Canada. Electronic address: cecilskchu@gmail.com.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2016.03.018']
794,32414331,"Patient information, communication and competence empowerment in oncology (PIKKO) - evaluation of a supportive care intervention for overall oncological patients. Study protocol of a non-randomized controlled trial.","BACKGROUND
Cancer patients have to undergo a difficult medical therapy and are also confronted with various psychological, social and economic problems. Support is available from many providers, but patients often gain no access to it. Accordingly, there is a need for a single point of contact that can provide advice, information and assistance. In the state of Saarland, Germany, a supportive new consulting and information path (PIKKO) for all types of cancer is currently evaluated by the German Cancer Society, the Cancer Society of the Saarland, three statutory health insurances and the Jena University Hospital. PIKKO is designed to improve quality of life, self-efficacy, health literacy and patient satisfaction and to reduce psychological distress, related health care costs and the days of inability to work. This methodical work presents the process and analysis planning of this evaluation.
METHODS
The study population includes all cancer types, both new and existing diseases. PIKKO (with patient navigator, oncological knowledge database, specialized oncological counseling) is evaluated within a controlled, non-randomized, comparative, multicenter, longitudinal design. In addition to patient surveys, data from statutory health insurances and utilization data from the web database are collected, and interviews with patient navigators and doctors are carried out. Patients are assigned to a control (usual care) or an intervention group (u. c. + PIKKO). Primary outcome is the health related quality of life (SF-12) six months after baseline. Secondary outcomes are self-efficacy (GSE), psychological distress such as depression (PHQ-9) or anxiety (GAD-7), health literacy (HLS-EU-Q47) and patient satisfaction in health care (Qualiskope-A). Furthermore, the time course of direct costs of medical care (e.g. work disability days) and usage data of the intervention modules are analyzed. Among other statistical procedures, we use t-tests, univariate tests and growth curve models.
DISCUSSION
If PIKKO proves to be effective, recommendations can be made to health organizations, which should lead to the concept being rolled out throughout Germany and included into oncological guidelines. We expect PIKKO to be a useful addition to usual cancer care, helping to improve the quality of life of cancer patients and reduce healthcare costs.
TRIAL REGISTRATION
This study was retrospectively registered in the German Clinical Trial Register under DRKS00016703 (21.02.2019, the reason for the delay was the prioritization of the study management in the first year to establish the new approach into practice). https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00016703.",2020,"PIKKO is designed to improve quality of life, self-efficacy, health literacy and patient satisfaction and to reduce psychological distress, related health care costs and the days of inability to work.","['Cancer patients', 'overall oncological patients']",['supportive care intervention'],"['quality of life, self-efficacy, health literacy and patient satisfaction', 'health related quality of life (SF-12', 'self-efficacy (GSE), psychological distress such as depression (PHQ-9) or anxiety (GAD-7), health literacy (HLS-EU-Q47) and patient satisfaction in health care (Qualiskope-A']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]","[{'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",,0.0946291,"PIKKO is designed to improve quality of life, self-efficacy, health literacy and patient satisfaction and to reduce psychological distress, related health care costs and the days of inability to work.","[{'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Schneider', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany. nico.schneider@med.uni-jena.de.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bäcker', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Brenk-Franz', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Keinki', 'Affiliation': 'German Cancer Society, Kuno-Fischer-Strasse 8, 14057, Berlin, Germany.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Hübner', 'Affiliation': 'Department of Hematology and Medical Oncology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Brandt', 'Affiliation': 'IKK Südwest, Berliner Promenade 1, 66111, Saarbrücken, Germany.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'von der Winkel', 'Affiliation': 'IKK Südwest, Berliner Promenade 1, 66111, Saarbrücken, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Hager', 'Affiliation': 'ze:roPraxen, Bodelschwinghstrasse 10/3, 68723, Schwetzingen, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Strauss', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Altmann', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany.'}]",BMC medical research methodology,['10.1186/s12874-020-01002-1']
795,32492302,"Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children.","BACKGROUND
Rituximab added to chemotherapy prolongs survival among adults with B-cell cancer. Data on its efficacy and safety in children with high-grade, mature B-cell non-Hodgkin's lymphoma are limited.
METHODS
We conducted an open-label, international, randomized, phase 3 trial involving patients younger than 18 years of age with high-risk, mature B-cell non-Hodgkin's lymphoma (stage III with an elevated lactate dehydrogenase level or stage IV) or acute leukemia to compare the addition of six doses of rituximab to standard lymphomes malins B (LMB) chemotherapy with standard LMB chemotherapy alone. The primary end point was event-free survival. Overall survival and toxic effects were also assessed.
RESULTS
Analyses were based on 328 patients who underwent randomization (164 patients per group); 85.7% of the patients had Burkitt's lymphoma. The median follow-up was 39.9 months. Events were observed in 10 patients in the rituximab-chemotherapy group and in 28 in the chemotherapy group. Event-free survival at 3 years was 93.9% (95% confidence interval [CI], 89.1 to 96.7) in the rituximab-chemotherapy group and 82.3% (95% CI, 75.7 to 87.5) in the chemotherapy group (hazard ratio for primary refractory disease or first occurrence of progression, relapse after response, death from any cause, or second cancer, 0.32; 95% CI, 0.15 to 0.66; one-sided P = 0.00096, which reached the significance level required for this analysis). Eight patients in the rituximab-chemotherapy group died (4 deaths were disease-related, 3 were treatment-related, and 1 was from a second cancer), as did 20 in the chemotherapy group (17 deaths were disease-related, and 3 were treatment-related) (hazard ratio, 0.36; 95% CI, 0.16 to 0.82). The incidence of acute adverse events of grade 4 or higher after prephase treatment was 33.3% in the rituximab-chemotherapy group and 24.2% in the chemotherapy group (P = 0.07); events were related mainly to febrile neutropenia and infection. Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion.
CONCLUSIONS
Rituximab added to standard LMB chemotherapy markedly prolonged event-free survival and overall survival among children and adolescents with high-grade, high-risk, mature B-cell non-Hodgkin's lymphoma and was associated with a higher incidence of hypogammaglobulinemia and, potentially, more episodes of infection. (Funded by the Clinical Research Hospital Program of the French Ministry of Health and others; ClinicalTrials.gov number, NCT01516580.).",2020,"Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion.
","['adults with B-cell cancer', ""children with high-grade, mature B-cell non-Hodgkin's lymphoma"", ""328 patients who underwent randomization (164 patients per group); 85.7% of the patients had Burkitt's lymphoma"", ""High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children"", ""patients younger than 18 years of age with high-risk, mature B-cell non-Hodgkin's lymphoma (stage III with an elevated lactate dehydrogenase level or stage IV) or acute leukemia to compare the addition of six doses of rituximab to standard lymphomes malins B ""]","['standard LMB chemotherapy', 'Rituximab', 'LMB) chemotherapy with standard LMB chemotherapy alone', 'rituximab-chemotherapy']","['Event-free survival', 'efficacy and safety', 'incidence of acute adverse events', 'febrile neutropenia and infection', 'prolonged event-free survival and overall survival', 'event-free survival', 'Overall survival and toxic effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0006413', 'cui_str': 'Burkitt lymphoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0151754', 'cui_str': '[D]Lactic acid dehydrogenase raised'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",328.0,0.163524,"Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion.
","[{'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Minard-Colin', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Aupérin', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Pillon', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'G A Amos', 'Initials': 'GAA', 'LastName': 'Burke', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Barkauskas', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Rafael F', 'Initials': 'RF', 'LastName': 'Delgado', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Uyttebroeck', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bollard', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'József', 'Initials': 'J', 'LastName': 'Zsiros', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Csoka', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Bernarda', 'Initials': 'B', 'LastName': 'Kazanowska', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Alan K', 'Initials': 'AK', 'LastName': 'Chiang', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Rodney R', 'Initials': 'RR', 'LastName': 'Miles', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wotherspoon', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Adamson', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Vassal', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Patte', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Gross', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915315']
796,32492577,Associations Between Food Insecurity and Parental Feeding Behaviors of Toddlers.,"OBJECTIVE
We examined associations between household food insecurity status and parental feeding behavior, weight perception, and child weight status in a diverse sample of young children.
METHODS
Cross-sectional analysis of 2-year-old children in Greenlight, a cluster randomized trial to prevent childhood obesity. The exposure was food insecurity, defined as a positive response to a validated screen. Outcomes were parent feeding behaviors/beliefs measured by the Child Feeding Questionnaire and child weight status. t tests and linear regression were used to assess associations between food insecurity and each outcome. We adjusted for child sex, race/ethnicity, parent education, employment, site, number of children in the home, and Special Supplemental Nutrition Program for Women, Infants, and Children status.
RESULTS
Five hundred three households (37%) were food insecure. After adjusting for covariates, parents from insecure households reported more pressuring feeding behaviors (mean factor score 3.2 compared to food secure parents mean factor score 2.9, P = .01) and were more worried about their child becoming overweight (mean factor score 2.3 vs 2.0; P = .02). No differences were observed in monitoring or restrictive feeding behaviors. After adjusting for covariates, there was no difference in weight status or prevalence of overweight/obesity of children or parents based on household food insecurity status.
CONCLUSIONS
Parents from food insecure households reported more pressuring feeding behaviors. This finding underscores the need to address food insecurity and potentially prevent harmful effects on child feeding. Parents in food insecure households might benefit from linkage with resources and education to develop healthier feeding behaviors.",2020,"After adjusting for covariates, parents from insecure households reported more pressuring feeding behaviors (mean factor score 3.2 compared to food secure parents mean factor score 2.9, p=0.01) and were more worried about their child becoming overweight (mean factor score 2.3 vs 2.0; p=0.02).","['503 households (37%) were food insecure', '2-year old children in Greenlight, a cluster randomized trial to prevent childhood obesity', 'Toddlers']",[],"['pressuring feeding behaviors', 'monitoring or restrictive feeding behaviors', 'weight status or prevalence of overweight/obesity', 'feeding behaviors/beliefs measured by the Child Feeding Questionnaire and child weight status']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}]",[],"[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",503.0,0.0299764,"After adjusting for covariates, parents from insecure households reported more pressuring feeding behaviors (mean factor score 3.2 compared to food secure parents mean factor score 2.9, p=0.01) and were more worried about their child becoming overweight (mean factor score 2.3 vs 2.0; p=0.02).","[{'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Orr', 'Affiliation': 'Division of General Pediatrics and Adolescent Medicine, Department of Pediatrics, University of North Carolina at Chapel (CJ Orr and KB Flower), Chapel Hill, NC. Electronic address: colin_orr@med.unc.edu.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Ravanbakht', 'Affiliation': 'Department of Pediatrics and Duke Center for Childhood Obesity Research, Duke University School of Medicine (S Ravanbakht and EM Perrin), Durham, NC.'}, {'ForeName': 'Kori B', 'Initials': 'KB', 'LastName': 'Flower', 'Affiliation': 'Division of General Pediatrics and Adolescent Medicine, Department of Pediatrics, University of North Carolina at Chapel (CJ Orr and KB Flower), Chapel Hill, NC.'}, {'ForeName': 'H Shonna', 'Initials': 'HS', 'LastName': 'Yin', 'Affiliation': 'Department of Pediatrics and Department of Population Health, New York University School of Medicine (HS Yin) New York, NY.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Rothman', 'Affiliation': 'Division of General and Internal Medicine, Department of Medicine, Vanderbilt University Medical Center (RL Rothman), Nashville, Tenn; Center for Health Services Research, Vanderbilt University Medical Center (RL Rothman), Nashville, Tenn.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Sanders', 'Affiliation': 'General Pediatrics, Department of Pediatrics, Stanford University of School of Medicine (LM Sanders), Stanford, Calif.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Delamater', 'Affiliation': 'Mailman Center for Child Development, University of Miami Miller School of Medicine (A Delamater), Miami, Fla.'}, {'ForeName': 'Eliana M', 'Initials': 'EM', 'LastName': 'Perrin', 'Affiliation': 'Department of Pediatrics and Duke Center for Childhood Obesity Research, Duke University School of Medicine (S Ravanbakht and EM Perrin), Durham, NC.'}]",Academic pediatrics,['10.1016/j.acap.2020.05.020']
797,26308780,Sustainability of improvements in medication adherence through a mobile health intervention.,"Context-Very few patient-centered, theory-guided programs for medication adherence and blood pressure control have been conducted in kidney transplant recipients. Objective-To evaluate preliminary indications of sustainability of improved blood pressure in kidney transplant recipients 12 months after completion of a 3-month randomized controlled trial of a mobile health pilot program to improve blood pressure and medication adherence. Participants and Design-A total of 18 of the 19 trial participants were contacted and all consented to inclusion in the retrospective analysis of their medical records showing their clinic-recorded systolic blood pressures at 3, 6, and 12 months following participation in the 3-month trial of a medical regimen self-management intervention. Results-A significant group difference in systolic blood pressure was observed longitudinally, indicating that the intervention group, as compared with the standard-care group, exhibited lower clinic-measured systolic blood pressures at the 12-month posttrial follow-up visit (P= .01). At 12-month follow-up, success in establishing and sustaining control of systolic blood pressure (<131 mm Hg) was greater in the intervention group (50%) than in the control group (11%). Conclusion-Patients in the intervention group continued to exhibit lower systolic blood pressure than did patients in the control group 12 months after the trial ended, suggesting that the intervention may have a durable impact on blood pressure control that most likely reflects sustained medication adherence. These findings will aid in the development of an adequately powered randomized controlled trial to address the sustainable impact of the intervention program on medication adherence and blood pressure control.",2015,"A significant group difference in systolic blood pressure was observed longitudinally, indicating that the intervention group, as compared with the standard-care group, exhibited lower clinic-measured systolic blood pressures at the 12-month posttrial follow-up visit (P= .01).","['kidney transplant recipients', 'kidney transplant recipients 12 months after completion', 'Participants and Design-A total of 18 of the 19 trial participants were contacted and all consented to inclusion in the retrospective analysis of their medical records showing their clinic-recorded systolic blood pressures at 3, 6, and 12 months following participation in the 3-month trial of a medical regimen self-management intervention']",['mobile health pilot program'],"['systolic blood pressure', 'medication adherence and blood pressure control', 'systolic blood pressures', 'blood pressure control', 'blood pressure and medication adherence', 'blood pressure']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0025102', 'cui_str': 'Medical Records'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0504428,"A significant group difference in systolic blood pressure was observed longitudinally, indicating that the intervention group, as compared with the standard-care group, exhibited lower clinic-measured systolic blood pressures at the 12-month posttrial follow-up visit (P= .01).","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'McGillicuddy', 'Affiliation': 'Medical University of South Carolina (JWM, DT, MM, SP, PKB, KDC, LS, AF, BB-J, FAT), College of Charleston (LS, AF), Charleston, South Carolina.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Taber', 'Affiliation': 'Medical University of South Carolina (JWM, DT, MM, SP, PKB, KDC, LS, AF, BB-J, FAT), College of Charleston (LS, AF), Charleston, South Carolina.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'Medical University of South Carolina (JWM, DT, MM, SP, PKB, KDC, LS, AF, BB-J, FAT), College of Charleston (LS, AF), Charleston, South Carolina.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Medical University of South Carolina (JWM, DT, MM, SP, PKB, KDC, LS, AF, BB-J, FAT), College of Charleston (LS, AF), Charleston, South Carolina.'}, {'ForeName': 'Prabhakar K', 'Initials': 'PK', 'LastName': 'Baliga', 'Affiliation': 'Medical University of South Carolina (JWM, DT, MM, SP, PKB, KDC, LS, AF, BB-J, FAT), College of Charleston (LS, AF), Charleston, South Carolina.'}, {'ForeName': 'Kenneth D', 'Initials': 'KD', 'LastName': 'Chavin', 'Affiliation': 'Medical University of South Carolina (JWM, DT, MM, SP, PKB, KDC, LS, AF, BB-J, FAT), College of Charleston (LS, AF), Charleston, South Carolina.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Sox', 'Affiliation': 'Medical University of South Carolina (JWM, DT, MM, SP, PKB, KDC, LS, AF, BB-J, FAT), College of Charleston (LS, AF), Charleston, South Carolina.'}, {'ForeName': 'April P', 'Initials': 'AP', 'LastName': 'Favela', 'Affiliation': 'Medical University of South Carolina (JWM, DT, MM, SP, PKB, KDC, LS, AF, BB-J, FAT), College of Charleston (LS, AF), Charleston, South Carolina.'}, {'ForeName': 'Brenda M', 'Initials': 'BM', 'LastName': 'Brunner-Jackson', 'Affiliation': 'Medical University of South Carolina (JWM, DT, MM, SP, PKB, KDC, LS, AF, BB-J, FAT), College of Charleston (LS, AF), Charleston, South Carolina.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Treiber', 'Affiliation': 'Medical University of South Carolina (JWM, DT, MM, SP, PKB, KDC, LS, AF, BB-J, FAT), College of Charleston (LS, AF), Charleston, South Carolina.'}]","Progress in transplantation (Aliso Viejo, Calif.)",['10.7182/pit2015975']
798,26432671,Statin Use and Adrenal Aldosterone Production in Hypertensive and Diabetic Subjects.,"BACKGROUND
Statins substantially reduce cardiovascular mortality and appear to have beneficial effects independent of their lipid-lowering properties. We evaluated the hypothesis that statin use may modulate the secretion of aldosterone, a well-known contributor to cardiovascular disease.
METHODS AND RESULTS
We measured adrenal hormones in 2 intervention studies. In study 1 in hypertensive subjects, aldosterone was analyzed at baseline and after angiotensin II stimulation on both high- and low-sodium diets (1122 observations, 15% on statins for >3 months). Statin users had 33% lower aldosterone levels in adjusted models (P<0.001). Cortisol was not modified by statins. In secondary analyses, the lowest aldosterone levels were seen with lipophilic statins and with higher doses. Statin users had lower blood pressure and reduced salt sensitivity of blood pressure (both P<0.001). In study 2, aldosterone was measured in diabetic patients on a high-sodium diet, before and after angiotensin II stimulation (143 observations, 79% statin users). Again, statin users had 26% lower aldosterone levels (P=0.006), particularly those using lipophilic statins. Ex vivo studies in rat adrenal glomerulosa cells confirmed that lipophilic statins acutely inhibited aldosterone, but not corticosterone, in response to different secretagogues.
CONCLUSIONS
Statin use among hypertensive and diabetic subjects was associated with lower aldosterone secretion in response to angiotensin II and a low-sodium diet in 2 human intervention studies. This effect appeared to be most pronounced with lipophilic statins and higher doses. Future studies to evaluate whether aldosterone inhibition may partially explain the robust cardioprotective effects of statins are warranted.",2015,"Again, statin users had 26% lower aldosterone levels (P=0.006), particularly those using lipophilic statins.","['diabetic patients', 'hypertensive and diabetic subjects', 'Hypertensive and Diabetic Subjects', 'hypertensive subjects']","['angiotensin II stimulation on both high- and low-sodium diets', 'aldosterone', 'Statin', 'lipophilic statins']","['blood pressure and reduced salt sensitivity of blood pressure', 'Adrenal Aldosterone Production', 'lowest aldosterone levels', 'cardiovascular mortality', 'aldosterone levels']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012169', 'cui_str': 'Diet, Low-Salt'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0033268'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.017302,"Again, statin users had 26% lower aldosterone levels (P=0.006), particularly those using lipophilic statins.","[{'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Baudrand', 'Affiliation': ""From Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (R.B., L.H.P., A.V., A.E.G., T.M.Y., J.W., G.K.A., G.H.W.); Department of Endocrinology, School Of Medicine, Pontificia Universidad Catolica De Chile, Santiago, Chile (R.B.); Hospital Clinico, Facultad Medicina Universidad de Chile, Santiago, Chile and Tufts Medical Center, Tufts University School of Medicine, Boston, MA (P.A.V.); Centre Investigation Clinique, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Universite Paris Descartes, Paris, France (X.J.); and Cardiovascular Genetics Research, University of Utah School of Medicine Salt Lake City (P.N.H.). rbaudran@uc.cl gwilliams@partners.org.""}, {'ForeName': 'Luminita H', 'Initials': 'LH', 'LastName': 'Pojoga', 'Affiliation': ""From Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (R.B., L.H.P., A.V., A.E.G., T.M.Y., J.W., G.K.A., G.H.W.); Department of Endocrinology, School Of Medicine, Pontificia Universidad Catolica De Chile, Santiago, Chile (R.B.); Hospital Clinico, Facultad Medicina Universidad de Chile, Santiago, Chile and Tufts Medical Center, Tufts University School of Medicine, Boston, MA (P.A.V.); Centre Investigation Clinique, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Universite Paris Descartes, Paris, France (X.J.); and Cardiovascular Genetics Research, University of Utah School of Medicine Salt Lake City (P.N.H.).""}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Vaidya', 'Affiliation': ""From Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (R.B., L.H.P., A.V., A.E.G., T.M.Y., J.W., G.K.A., G.H.W.); Department of Endocrinology, School Of Medicine, Pontificia Universidad Catolica De Chile, Santiago, Chile (R.B.); Hospital Clinico, Facultad Medicina Universidad de Chile, Santiago, Chile and Tufts Medical Center, Tufts University School of Medicine, Boston, MA (P.A.V.); Centre Investigation Clinique, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Universite Paris Descartes, Paris, France (X.J.); and Cardiovascular Genetics Research, University of Utah School of Medicine Salt Lake City (P.N.H.).""}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Garza', 'Affiliation': ""From Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (R.B., L.H.P., A.V., A.E.G., T.M.Y., J.W., G.K.A., G.H.W.); Department of Endocrinology, School Of Medicine, Pontificia Universidad Catolica De Chile, Santiago, Chile (R.B.); Hospital Clinico, Facultad Medicina Universidad de Chile, Santiago, Chile and Tufts Medical Center, Tufts University School of Medicine, Boston, MA (P.A.V.); Centre Investigation Clinique, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Universite Paris Descartes, Paris, France (X.J.); and Cardiovascular Genetics Research, University of Utah School of Medicine Salt Lake City (P.N.H.).""}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Vöhringer', 'Affiliation': ""From Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (R.B., L.H.P., A.V., A.E.G., T.M.Y., J.W., G.K.A., G.H.W.); Department of Endocrinology, School Of Medicine, Pontificia Universidad Catolica De Chile, Santiago, Chile (R.B.); Hospital Clinico, Facultad Medicina Universidad de Chile, Santiago, Chile and Tufts Medical Center, Tufts University School of Medicine, Boston, MA (P.A.V.); Centre Investigation Clinique, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Universite Paris Descartes, Paris, France (X.J.); and Cardiovascular Genetics Research, University of Utah School of Medicine Salt Lake City (P.N.H.).""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Jeunemaitre', 'Affiliation': ""From Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (R.B., L.H.P., A.V., A.E.G., T.M.Y., J.W., G.K.A., G.H.W.); Department of Endocrinology, School Of Medicine, Pontificia Universidad Catolica De Chile, Santiago, Chile (R.B.); Hospital Clinico, Facultad Medicina Universidad de Chile, Santiago, Chile and Tufts Medical Center, Tufts University School of Medicine, Boston, MA (P.A.V.); Centre Investigation Clinique, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Universite Paris Descartes, Paris, France (X.J.); and Cardiovascular Genetics Research, University of Utah School of Medicine Salt Lake City (P.N.H.).""}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Hopkins', 'Affiliation': ""From Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (R.B., L.H.P., A.V., A.E.G., T.M.Y., J.W., G.K.A., G.H.W.); Department of Endocrinology, School Of Medicine, Pontificia Universidad Catolica De Chile, Santiago, Chile (R.B.); Hospital Clinico, Facultad Medicina Universidad de Chile, Santiago, Chile and Tufts Medical Center, Tufts University School of Medicine, Boston, MA (P.A.V.); Centre Investigation Clinique, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Universite Paris Descartes, Paris, France (X.J.); and Cardiovascular Genetics Research, University of Utah School of Medicine Salt Lake City (P.N.H.).""}, {'ForeName': 'Tham M', 'Initials': 'TM', 'LastName': 'Yao', 'Affiliation': ""From Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (R.B., L.H.P., A.V., A.E.G., T.M.Y., J.W., G.K.A., G.H.W.); Department of Endocrinology, School Of Medicine, Pontificia Universidad Catolica De Chile, Santiago, Chile (R.B.); Hospital Clinico, Facultad Medicina Universidad de Chile, Santiago, Chile and Tufts Medical Center, Tufts University School of Medicine, Boston, MA (P.A.V.); Centre Investigation Clinique, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Universite Paris Descartes, Paris, France (X.J.); and Cardiovascular Genetics Research, University of Utah School of Medicine Salt Lake City (P.N.H.).""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': ""From Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (R.B., L.H.P., A.V., A.E.G., T.M.Y., J.W., G.K.A., G.H.W.); Department of Endocrinology, School Of Medicine, Pontificia Universidad Catolica De Chile, Santiago, Chile (R.B.); Hospital Clinico, Facultad Medicina Universidad de Chile, Santiago, Chile and Tufts Medical Center, Tufts University School of Medicine, Boston, MA (P.A.V.); Centre Investigation Clinique, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Universite Paris Descartes, Paris, France (X.J.); and Cardiovascular Genetics Research, University of Utah School of Medicine Salt Lake City (P.N.H.).""}, {'ForeName': 'Gail K', 'Initials': 'GK', 'LastName': 'Adler', 'Affiliation': ""From Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (R.B., L.H.P., A.V., A.E.G., T.M.Y., J.W., G.K.A., G.H.W.); Department of Endocrinology, School Of Medicine, Pontificia Universidad Catolica De Chile, Santiago, Chile (R.B.); Hospital Clinico, Facultad Medicina Universidad de Chile, Santiago, Chile and Tufts Medical Center, Tufts University School of Medicine, Boston, MA (P.A.V.); Centre Investigation Clinique, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Universite Paris Descartes, Paris, France (X.J.); and Cardiovascular Genetics Research, University of Utah School of Medicine Salt Lake City (P.N.H.).""}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Williams', 'Affiliation': ""From Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (R.B., L.H.P., A.V., A.E.G., T.M.Y., J.W., G.K.A., G.H.W.); Department of Endocrinology, School Of Medicine, Pontificia Universidad Catolica De Chile, Santiago, Chile (R.B.); Hospital Clinico, Facultad Medicina Universidad de Chile, Santiago, Chile and Tufts Medical Center, Tufts University School of Medicine, Boston, MA (P.A.V.); Centre Investigation Clinique, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Universite Paris Descartes, Paris, France (X.J.); and Cardiovascular Genetics Research, University of Utah School of Medicine Salt Lake City (P.N.H.). rbaudran@uc.cl gwilliams@partners.org.""}]",Circulation,['10.1161/CIRCULATIONAHA.115.016759']
799,31540607,Effects of access barriers and medication acceptability on buprenorphine-naloxone treatment utilization over 2 years: Results from a multisite randomized trial of adults with opioid use disorder.,"BACKGROUND
Nationwide efforts seek to address the opioid epidemic by increasing access to medications for opioid use disorder (OUD), particularly with buprenorphine. A poorly understood challenge is that among individuals with OUD who do receive buprenorphine, many do not adhere to the pharmacotherapy long enough to achieve sustained benefits. We aimed to identify factors associated with buprenorphine treatment utilization over time.
METHODS
We used random-intercept modeling to identify factors associated with buprenorphine treatment utilization over 2 years after first follow-up by 789 individuals with OUD who had participated in a multi-site randomized clinical trial of buprenorphine compared to methadone. Key predictors were participants' reports of buprenorphine treatment accessibility and acceptability (assessed at first follow-up) and their interaction effects, controlling for baseline randomization status, sociodemographics, and other covariates.
RESULTS
Approximately 9.3-11.2% of participants utilized buprenorphine treatment over the 2 years of follow-up. Interaction effects indicated that individuals who perceived buprenorphine to be both accessible and acceptable were most likely to use buprenorphine during follow-up, controlling for other factors. In contrast, individuals who perceived buprenorphine to be unacceptable were least likely to use buprenorphine, regardless the level of perceived access to the medication. Buprenorphine treatment utilization was also negatively associated with Hispanic ethnicity, West coast context, and cumulative months receiving methadone treatment and incarceration during follow-up.
CONCLUSIONS
To engage more individuals with OUD in long-term treatment with buprenorphine, interventions should target buprenorphine treatment acceptability, in addition to increasing buprenorphine access, and tailor efforts to meet the needs of vulnerable populations.
TRIAL REGISTRATION
The START Follow-up Study on ClinicalTrials.gov (NCT01592461).",2019,"Interaction effects indicated that individuals who perceived buprenorphine to be both accessible and acceptable were most likely to use buprenorphine during follow-up, controlling for other factors.","['over 2\u202fyears after first follow-up by 789 individuals with OUD who had participated in a multi-site randomized clinical trial of', 'individuals with OUD', 'adults with opioid use disorder', '2\u202fyears']","['methadone', 'buprenorphine-naloxone', 'buprenorphine', 'Buprenorphine', 'buprenorphine treatment utilization']",['Interaction effects'],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042153', 'cui_str': 'use'}]","[{'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",789.0,0.0456768,"Interaction effects indicated that individuals who perceived buprenorphine to be both accessible and acceptable were most likely to use buprenorphine during follow-up, controlling for other factors.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Evans', 'Affiliation': 'Department of Health Promotion and Policy, School of Public Health and Health Sciences, University of Massachusetts Amherst, 312 Arnold House, 715 North Pleasant St. Amherst, MA 01003, USA. Electronic address: eaevans@umass.edu.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Yoo', 'Affiliation': 'UCLA Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior, 11075 Santa Monica Blvd. Ste 200, Los Angeles, CA 90024. USA. Electronic address: cyoo5@ucla.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'UCLA Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior, 11075 Santa Monica Blvd. Ste 200, Los Angeles, CA 90024. USA. Electronic address: yhuang@ucla.edu.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Saxon', 'Affiliation': 'Veterans Affairs Puget Sound Health Care System, 1660 S Columbian Way, Seattle, WA 98108, USA. Electronic address: Andrew.Saxon@va.gov.'}, {'ForeName': 'Yih-Ing', 'Initials': 'YI', 'LastName': 'Hser', 'Affiliation': 'UCLA Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior, 11075 Santa Monica Blvd. Ste 200, Los Angeles, CA 90024. USA. Electronic address: yhser@ucla.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.08.002']
800,32419378,An oral health optimized diet reduces the load of potential cariogenic and periodontal bacterial species in the supragingival oral plaque: A randomized controlled pilot study.,"This study aimed to investigate the effects of an oral health optimized diet on the composition of the supragingival oral plaque in a randomized controlled trial. Participants of the standard diet group (n = 5) had a diet high in processed carbohydrates and did not change their dietary behavior during the observation. The healthy diet group (n = 9) had to change the diet after 2 weeks from a diet high in processed carbohydrates to a diet low in carbohydrates, rich in omega-3 fatty acids, rich in vitamins C and D, antioxidants and fiber for 4 weeks. Saliva and supragingival plaque samples were taken at the end of week two and eight of the observation period to investigate the composition of microbiota in saliva and supragingival plaque. Data were subjected to an exploratory analysis to identify significant differences. Statistically significant differences were only found in the healthy diet group between the baseline (week 2) and the final sample (week 8) for specific species in plaque and saliva samples. A reduction of the total counts of Streptococcus mitis group, Granulicatella adiacens, Actinomyces spp., and Fusobacterium spp. was found in plaque samples of the healthy diet group. In saliva samples of the healthy diet group, the total counts of Actinomyces spp. and Capnocytophaga spp. decreased. A diet low in carbohydrates, rich in omega-3 fatty acids, rich in vitamins C and D, and rich in fiber reduced Streptococcus mitis group, Granulicatella adiacens, Actinomyces spp., and Fusobacterium spp. in the supragingival plaque.",2020,"A reduction of the total counts of Streptococcus mitis group, Granulicatella adiacens, Actinomyces spp., and Fusobacterium spp. was found in plaque samples of the healthy diet group.",[],"['diet high in processed carbohydrates', 'diet high in processed carbohydrates to a diet low in carbohydrates, rich in omega-3 fatty acids, rich in vitamins C and D, antioxidants and fiber for 4\xa0weeks', 'oral health optimized diet']",['total counts of Actinomyces spp'],[],"[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0001250', 'cui_str': 'Actinomyces'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}]",,0.0238515,"A reduction of the total counts of Streptococcus mitis group, Granulicatella adiacens, Actinomyces spp., and Fusobacterium spp. was found in plaque samples of the healthy diet group.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tennert', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Reinmuth', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Bremer', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al-Ahmad', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Lamprini', 'Initials': 'L', 'LastName': 'Karygianni', 'Affiliation': 'Clinic of Preventive Dentistry, Periodontology and Cariology, Center of Dental Medicine, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Hellwig', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Vach', 'Affiliation': 'Department of Medical Biometry and Statistics, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Ratka-Krüger', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Wittmer', 'Affiliation': 'Department of Microbiology and Hygiene, Institute of Medical Microbiology and Hygiene, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Johan Peter', 'Initials': 'JP', 'LastName': 'Woelber', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}]",MicrobiologyOpen,['10.1002/mbo3.1056']
801,32419491,Short- and Midterm Adherence to Platelet P2Y12 Receptor Inhibitors After Percutaneous Coronary Intervention With Drug-Eluting Stents.,"INTRODUCTION/OBJECTIVES
In patients who have undergone recent percutaneous coronary intervention (PCI), poor adhesion to antiplatelet agents may increase the risk of stent thrombosis and death. We aimed to investigate the adherence to different P2Y12 receptor inhibitors after PCI with drug-eluting stent in stable and unstable patients and to evaluate the factors associated with low adherence.
METHOD
In a prospective study conducted between 2014 and 2018, the 8-item Morisky scale was applied at 30 days and 6 months post-PCI to measure P2Y12 receptor inhibitors adherence. Also, we describe the characteristics of patients using different platelet receptor P2Y12 inhibitors. Regression models were used to identify predictors of poor adherence.
RESULTS
A total of 214 patients were included (65 ± 12 years, 81% man, 61% acute coronary syndromes). Patients in the clopidogrel group were older than those in the prasugrel (68 ± 12 vs 59 ± 11 years, P < .01, respectively) or ticagrelor group (68 ± 12 vs 62 ± 12 years, P < .01). Patients with low/moderate adherence at 30 days and 6 months represented, respectively, 19.8% and 27.5% of our sample. Current smokers and preexisting cardiovascular disease at presentation were associated with lower adherence at 30 days.
CONCLUSIONS
We found substantial rates of moderate and low adherence to P2Y12 receptor inhibitors early after PCI. Current smokers and preexisting cardiovascular disease at presentation were associated with a lower likelihood of adherence. These results highlight the need of monitoring adherence to medical treatment after PCI.",2020,"Patients in the clopidogrel group were older than those in the prasugrel (68 ± 12 vs 59 ± 11 years, P < .01, respectively) or ticagrelor group (68 ± 12 vs 62 ± 12 years, P < .01).","['A total of 214 patients were included (65 ± 12 years, 81% man, 61% acute coronary syndromes', 'patients who have undergone recent percutaneous coronary intervention (PCI']","['Percutaneous Coronary Intervention With Drug-Eluting Stents', 'Platelet P2Y12 Receptor Inhibitors', 'clopidogrel', 'ticagrelor']",['risk of stent thrombosis and death'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",214.0,0.0204004,"Patients in the clopidogrel group were older than those in the prasugrel (68 ± 12 vs 59 ± 11 years, P < .01, respectively) or ticagrelor group (68 ± 12 vs 62 ± 12 years, P < .01).","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Morita', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Wajngarten', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Katz', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Miguel Morita', 'Initials': 'MM', 'LastName': 'Fernandes-Silva', 'Affiliation': 'Department of Internal Medicine, Universidade Federal do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Caixeta', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Franken', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Lemos', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Antonio E', 'Initials': 'AE', 'LastName': 'Pesaro', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420926667']
802,32419594,Stromal Cell-Derived Factor-1 Plasmid Treatment for Patients With Peripheral Artery Disease (STOP-PAD) Trial: Six-Month Results.,"Purpose: To present the 6-month results of the S tromal Cell-Derived Factor-1 Plasmid T reatment f o r P atients with P eripheral A rtery D isease (STOP-PAD) trial. The trial was an attempt to alter the course of chronic limb-threatening ischemia (CLTI) with a biological agent vs placebo after successful arterial revascularization at or below the knee. Materials and Methods: The multicenter, randomized, double-blinded, placebo-controlled, phase 2B STOP-PAD trial ( ClinicalTrials.gov identifier NCT02544204) randomized 109 patients (mean age 71 years; 68 men) with Rutherford category 5 or 6 CLTI and evidence of persistent impaired forefoot perfusion following recent successful revascularization to 8- (n=34) or 16-mg (n=36) intramuscular injections of a non-viral DNA plasmid-based treatment vs placebo (n=34). The primary efficacy outcome was the 6-month wound healing score evaluated by an independent wound core laboratory; the primary safety endpoint was major adverse limb events (MALE), a composite of major amputation plus clinically-driven target lesion revascularization at 6 months. Results: Only one-third of the patients had complete wound healing at 6 months in the placebo (31%), 8-mg injection (33%), and 16-mg injection (33%) groups. In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups). During the 6-month period, 6 patients (6%) died, and 24 patients (23%) had an amputation [only 4 (4%) major]. Conclusion: Combining revascularization and biological therapy failed to improve outcomes in CLTI at 6 months. STOP-PAD has provided insights for future trials to evaluate biological therapy.",2020,"In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups).","['109 patients (mean age 71 years; 68 men) with Rutherford category 5 or 6 CLTI and evidence of persistent impaired forefoot perfusion following recent successful revascularization to 8- (n=34) or', '16-mg (n=36', 'Patients With Peripheral Artery Disease']","['Stromal Cell-Derived Factor-1 Plasmid Treatment', 'intramuscular injections of a non-viral DNA plasmid-based treatment vs placebo', 'S tromal Cell-Derived Factor-1 Plasmid T reatment', 'biological agent vs placebo', 'placebo']","['toe-brachial index', '6-month wound healing score evaluated by an independent wound core laboratory; the primary safety endpoint was major adverse limb events (MALE), a composite of major amputation plus clinically-driven target lesion revascularization at 6 months', 'complete wound healing', 'rates of MALE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}]","[{'cui': 'C0218504', 'cui_str': 'CXCL12 Chemokine'}, {'cui': 'C0032136', 'cui_str': 'Plasmid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0012939', 'cui_str': 'Viral DNA'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]","[{'cui': 'C2116889', 'cui_str': 'Toe brachial index'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",109.0,0.510948,"In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups).","[{'ForeName': 'Tarek A', 'Initials': 'TA', 'LastName': 'Hammad', 'Affiliation': 'Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rundback', 'Affiliation': 'Interventional Institute, Holy Name Medical Center, Teaneck, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bunte', 'Affiliation': ""Saint Luke's Mid America Heart Institute, St Luke's Hospital and University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA.""}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'BayCare Physician Partners, Clearwater, FL, USA.'}, {'ForeName': 'Parag D', 'Initials': 'PD', 'LastName': 'Patel', 'Affiliation': 'BayCare Physician Partners, Clearwater, FL, USA.'}, {'ForeName': 'Saihari', 'Initials': 'S', 'LastName': 'Sadanandan', 'Affiliation': ""St Joseph's Hospital, Tampa, FL, USA.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fitzgerald', 'Affiliation': 'Juventas Therapeutics, Cleveland, OH, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pastore', 'Affiliation': 'Juventas Therapeutics, Cleveland, OH, USA.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kashyap', 'Affiliation': 'Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Christ Hospital, Cincinnati, OH, USA.'}, {'ForeName': 'Mehdi H', 'Initials': 'MH', 'LastName': 'Shishehbor', 'Affiliation': 'Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602820919951']
803,31551097,Neurobiological mechanisms of social cognition treatment in high-functioning adults with autism spectrum disorder.,"BACKGROUND
The promise of precision medicine for autism spectrum disorder (ASD) hinges on developing neuroscience-informed individualized interventions. Taking an important step in this direction, we investigated neuroplasticity in response to an ecologically-valid, computer-based social-cognitive training (SCOTT).
METHODS
In an active control group design, 48 adults with ASD were randomly assigned to a 3-month SCOTT or non-social computer training. Participants completed behavioral tasks, a functional and structural magnetic resonance imaging session before and after the training period.
RESULTS
The SCOTT group showed social-cognitive improvements on close and distant generalization tasks. The improvements scaled with reductions in functional activity and increases in cortical thickness in prefrontal regions.
CONCLUSION
In sum, we provide evidence for the sensitivity of neuroscientific methods to reflect training-induced social-cognitive improvements in adults with ASD. These results encourage the use of neuroimaging data to describe and quantify treatment-related changes more broadly.",2020,"The improvements scaled with reductions in functional activity and increases in cortical thickness in prefrontal regions.
","['48 adults with ASD', 'high-functioning adults with autism spectrum disorder', 'adults with ASD', 'autism spectrum disorder (ASD']","['3-month SCOTT or non-social computer training', 'social cognition treatment']","['social-cognitive improvements on close and distant generalization tasks', 'cortical thickness in prefrontal regions', 'functional activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0017324', 'cui_str': 'Generalization'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",48.0,0.040454,"The improvements scaled with reductions in functional activity and increases in cortical thickness in prefrontal regions.
","[{'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Rosenblau', 'Affiliation': ""Cluster of Excellence 'Languages of Emotion', Freie Universität Berlin, Berlin14195, Germany.""}, {'ForeName': 'Garret', 'Initials': 'G', 'LastName': ""O'Connell"", 'Affiliation': 'Berlin School of Mind and Brain, Institute of Psychology, Humboldt-Universität zu Berlin, Unter den Linden 6, 10099, Berlin, Germany.'}, {'ForeName': 'Hauke R', 'Initials': 'HR', 'LastName': 'Heekeren', 'Affiliation': ""Cluster of Excellence 'Languages of Emotion', Freie Universität Berlin, Berlin14195, Germany.""}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Dziobek', 'Affiliation': ""Cluster of Excellence 'Languages of Emotion', Freie Universität Berlin, Berlin14195, Germany.""}]",Psychological medicine,['10.1017/S0033291719002472']
804,32065601,Effect of No Prehydration vs Sodium Bicarbonate Prehydration Prior to Contrast-Enhanced Computed Tomography in the Prevention of Postcontrast Acute Kidney Injury in Adults With Chronic Kidney Disease: The Kompas Randomized Clinical Trial.,"Importance
Prevention of postcontrast acute kidney injury in patients with stage 3 chronic kidney disease (CKD) by means of prehydration has been standard care for years. However, evidence for the need for prehydration in this group is limited.
Objective
To assess the renal safety of omitting prophylactic prehydration prior to iodine-based contrast media administration in patients with stage 3 CKD.
Design, Setting, and Participants
The Kompas trial was a multicenter, noninferiority, randomized clinical trial conducted at 6 hospitals in the Netherlands in which 523 patients with stage 3 CKD were randomized in a 1:1 ratio to receive no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate administered in a 1-hour infusion before undergoing elective contrast-enhanced computed tomography from April 2013 through September 2016. Final follow-up was completed in September 2017. Data were analyzed from January 2018 to June 2019.
Interventions
In total, 262 patients were allocated to the no prehydration group and 261 were allocated to receive prehydration. Analysis on the primary end point was available in 505 patients (96.6%).
Main Outcomes and Measures
The primary end point was the mean relative increase in serum creatinine level 2 to 5 days after contrast administration compared with baseline (noninferiority margin of less than 10% increase in serum creatinine level). Secondary outcomes included the incidence of postcontrast acute kidney injury 2 to 5 days after contrast administration, mean relative increase in creatinine level 7 to 14 days after contrast administration, incidences of acute heart failure and renal failure requiring dialysis, and health care costs.
Results
Of 554 patients randomized, 523 were included in the intention-to-treat analysis. The median (interquartile range) age was 74 (67-79) years; 336 (64.2%) were men and 187 (35.8%) were women. The mean (SD) relative increase in creatinine level 2 to 5 days after contrast administration compared with baseline was 3.0% (10.5) in the no prehydration group vs 3.5% (10.3) in the prehydration group (mean difference, 0.5; 95% CI, -1.3 to 2.3; P < .001 for noninferiority). Postcontrast acute kidney injury occurred in 11 patients (2.1%), including 7 of 262 (2.7%) in the no prehydration group and 4 of 261 (1.5%) in the prehydration group, which resulted in a relative risk of 1.7 (95% CI, 0.5-5.9; P = .36). None of the patients required dialysis or developed acute heart failure. Subgroup analyses showed no evidence of statistical interactions between treatment arms and predefined subgroups. Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001). Other health care costs were similar.
Conclusions and Relevance
Among patients with stage 3 CKD undergoing contrast-enhanced computed tomography, withholding prehydration did not compromise patient safety. The findings of this study support the option of not giving prehydration as a safe and cost-efficient measure.
Trial Registration
Netherlands Trial Register Identifier: NTR3764.",2020,Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001).,"['6 hospitals in the Netherlands in which 523 patients with stage 3 CKD', '262 patients', 'patients with stage', 'The median (interquartile range) age was 74 (67-79) years; 336 (64.2%) were men and 187 (35.8%) were women', 'patients with stage 3 CKD', 'patients with stage 3 chronic kidney disease (CKD', 'Adults With Chronic Kidney Disease', '554 patients randomized', 'Data were analyzed from January 2018 to June 2019']","['prehydration', 'no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate', 'omitting prophylactic prehydration prior to iodine-based contrast media administration', 'Contrast-Enhanced Computed Tomography', 'No Prehydration vs Sodium Bicarbonate Prehydration']","['incidence of postcontrast acute kidney injury 2 to 5 days after contrast administration, mean relative increase in creatinine level 7 to 14 days after contrast administration, incidences of acute heart failure and renal failure requiring dialysis, and health care costs', 'Postcontrast acute kidney injury', 'Mean hydration costs', 'serum creatinine level', 'mean (SD) relative increase in creatinine level', 'renal safety', 'safe and cost-efficient measure', 'acute heart failure']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009924', 'cui_str': 'Contrast Agents'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442799', 'cui_str': 'Efficient (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",262.0,0.201305,Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001).,"[{'ForeName': 'Rohit J', 'Initials': 'RJ', 'LastName': 'Timal', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Kooiman', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Yvo W J', 'Initials': 'YWJ', 'LastName': 'Sijpkens', 'Affiliation': 'Department of Internal Medicine, Haaglanden Medisch Centrum Bronovo, The Hague, the Netherlands.'}, {'ForeName': 'Jean-Paul P M', 'Initials': 'JPM', 'LastName': 'de Vries', 'Affiliation': 'Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Iris J A M', 'Initials': 'IJAM', 'LastName': 'Verberk-Jonkers', 'Affiliation': 'Department of Internal Medicine, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Harald F H', 'Initials': 'HFH', 'LastName': 'Brulez', 'Affiliation': 'Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'van Buren', 'Affiliation': 'Department of Internal Medicine, Haga Teaching Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Aart J', 'Initials': 'AJ', 'LastName': 'van der Molen', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Cannegieter', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Wilbert B', 'Initials': 'WB', 'LastName': 'van den Hout', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Ton J', 'Initials': 'TJ', 'LastName': 'Rabelink', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Menno V', 'Initials': 'MV', 'LastName': 'Huisman', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.7428']
805,32424502,Is there an association between perceived social support and cardiovascular health behaviours in people with severe mental illnesses?,"PURPOSE
People with severe mental illnesses (SMI) have an increased risk of cardiovascular disease (CVD). Research in the general population suggests that social support may protect against increased CVD morbidity and mortality; however, this may not apply to those with SMI. We aimed to explore the association between perceived social support and attendance at primary care nurse CVD risk reduction clinic appointments and CVD risk-reducing behaviours in an SMI population with elevated CVD risk factors.
METHODS
We used longitudinal and cross-sectional data from a randomised controlled trial on 326 adults with SMI recruited via 76 general practices in England. Multilevel regression analysis estimated the effect of perceived social support on attendance at CVD risk reduction clinic appointments over 6 months, and adherence to CVD medication, physical activity, diet, smoking and alcohol use at baseline, adjusted by age, sex, ethnicity, deprivation, psychiatric diagnosis and employment.
RESULTS
Perceived social support predicted greater appointment attendance in unadjusted (IRR = 1.005; 1.000-1.010; p = 0.05) but not adjusted analysis (IRR = 1.003; 0.998-1.009; p = 0.25). Perceived social support was associated with greater adherence to medication; for each 1% increase in social support, there was a 4.2% increase in medication adherence (OR = 1.042; 1.015-1.070; p = 0.002). No association was found between greater perceived social support and greater physical activity, lower sedentary behaviour, healthier diet, lower alcohol use or being a non-smoker.
CONCLUSIONS
Social support may be an important facilitator for CVD medication adherence and is potentially important for primary care appointment attendance; however, alternative strategies might be needed to help people with SMI engage in physical activity, healthier diets and to reduce their smoking and alcohol use.",2020,"No association was found between greater perceived social support and greater physical activity, lower sedentary behaviour, healthier diet, lower alcohol use or being a non-smoker.
CONCLUSIONS
Social support may be an important facilitator for CVD medication adherence and is potentially important for primary care appointment attendance; however, alternative strategies might be needed to help people with SMI engage in physical activity, healthier diets and to reduce their smoking and alcohol use.","['SMI population with elevated CVD risk factors', '326 adults with SMI recruited via 76 general practices in England', 'People with severe mental illnesses (SMI', 'people with severe mental illnesses']",[],"['CVD morbidity and mortality', 'appointment attendance', 'adherence to CVD medication, physical activity, diet, smoking and alcohol use at baseline, adjusted by age, sex, ethnicity, deprivation, psychiatric diagnosis and employment', 'social support and greater physical activity, lower sedentary behaviour, healthier diet', 'risk of cardiovascular disease (CVD', 'social support', 'medication adherence']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0376338', 'cui_str': 'Psychiatric Diagnosis'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",326.0,0.0483254,"No association was found between greater perceived social support and greater physical activity, lower sedentary behaviour, healthier diet, lower alcohol use or being a non-smoker.
CONCLUSIONS
Social support may be an important facilitator for CVD medication adherence and is potentially important for primary care appointment attendance; however, alternative strategies might be needed to help people with SMI engage in physical activity, healthier diets and to reduce their smoking and alcohol use.","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Burton', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 6th floor, 149 Tottenham Court Road, London, W1T 7NF, UK. a.burton@ucl.ac.uk.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Walters', 'Affiliation': 'Department of Primary Care and Population Health, University College London, UCL Medical School (Royal Free Campus), Upper Third Floor, Rowland Hill Street, London, NW3 2PF, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Department of Primary Care and Population Health, University College London, UCL Medical School (Royal Free Campus), Upper Third Floor, Rowland Hill Street, London, NW3 2PF, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 6th floor, 149 Tottenham Court Road, London, W1T 7NF, UK.'}]",Social psychiatry and psychiatric epidemiology,['10.1007/s00127-020-01879-9']
806,32421168,Effect of Patient Portal Reminders Sent by a Health Care System on Influenza Vaccination Rates: A Randomized Clinical Trial.,"Importance
Influenza vaccination rates across the US are low. Because few practices send patient reminders for influenza vaccination, a scalable patient reminder system is needed.
Objective
To evaluate the effect of patient reminders sent via a health care system's electronic health record patient portal on influenza vaccination rates.
Design, Setting, and Participants
This pragmatic, 4-arm randomized clinical trial was performed from October 1, 2018, to March 31, 2019, across the UCLA (University of California, Los Angeles) health care system. A total of 164 205 patients in 52 primary care practices who had used the patient portal within 12 months were included.
Interventions
Patients due for an influenza vaccine were sent a letter via the patient portal of the health care system reminding them about the importance of influenza vaccination, safety of the vaccine, and morbidity associated with influenza. Patients were randomized within primary care practices to 1 of 4 study groups (no reminder [n = 41 070] vs 1 reminder [n = 41 055], 2 reminders [n = 41 046], or 3 reminders [n = 41 034]).
Main Outcomes and Measures
The primary outcome was receipt of 1 or more influenza vaccines as documented in the electronic health record, which was supplemented with influenza vaccination data from external sources (eg, pharmacies). Secondary outcomes were influenza vaccination rates among subgroups and influenza vaccinations self-reported by patients in reply to the portal-based query as having been received elsewhere.
Results
A total of 164 205 patients (mean [SD] age, 46.2 [19.6] years; 95 779 [58.3%] female) were randomly allocated to 1 of the 4 study arms. In the primary analysis across all ages and not including patient self-reported vaccinations in reply to portal reminders, influenza vaccination rates were 37.5% for those receiving no reminders, 38.0% for those receiving 1 reminder (P = .008 vs no reminder), 38.2% for those receiving 2 reminders (P = .03 vs no reminder), and 38.2% for those receiving 3 reminders (P = .02 vs no reminder). In the secondary analysis not including patient self-reported vaccinations, among adults aged 18 to 64 years (vaccination rates: 32.0% in the control group, 32.8% in the 1-reminder group, 32.8% in the 2-reminder group, and 32.8% in the 3-reminder group; P = .001), male patients (vaccination rates: 37.3% vs 38.3%, 38.6%, and 38.8%; P = .001), non-Hispanic patients (vaccination rates: 37.6% vs 38.2%, 38.3%, and 38.2%; P = .004), and those who were not vaccinated in the prior 2 years (vaccination rates: 15.3% vs 15.9%, 16.3%, and 16.1%; P < .001), vaccination rates were higher in the portal reminder groups than in the control group; the findings in these 3 subgroups mirrored the findings in the entire population. When self-reported vaccinations received elsewhere were included, influenza vaccination rates were 1.4 to 2.9 percentage points higher in the portal reminder groups, with a dose-response effect (0 reminders: 15 537 [37.8%]; 1 reminder: 16 097 [39.2%]; 2 reminders: 16 426 [40.0%]; and 3 reminders: 16 714 [40.7%]; P < .001).
Conclusions and Relevance
Generic patient portal reminders were effective in minimally increasing influenza vaccination rates, but more intensive or more targeted patient motivational strategies appear to be needed.
Trial Registration
ClinicalTrials.gov Identifier: NCT03666026.",2020,"Conclusions and Relevance
Generic patient portal reminders were effective in minimally increasing influenza vaccination rates, but more intensive or more targeted patient motivational strategies appear to be needed.
","['October 1, 2018, to March 31, 2019, across the UCLA (University of California, Los Angeles) health care system', 'A total of 164\u202f205 patients (mean [SD] age, 46.2 [19.6] years; 95 779 [58.3%] female', '164 205 patients in 52 primary care practices who had used the patient portal within 12 months were included']","['no reminder [n\u2009=\u200941 070] vs 1 reminder [n\u2009=\u200941 055], 2 reminders [n\u2009=\u200941 046], or 3 reminders [n\u2009=\u200941 034']","['Influenza Vaccination Rates', 'influenza vaccination data from external sources (eg, pharmacies', 'influenza vaccination rates', 'patient self-reported vaccinations in reply to portal reminders, influenza vaccination rates', 'vaccination rates', 'receipt of 1 or more influenza vaccines', 'influenza vaccination rates among subgroups and influenza vaccinations self-reported by patients in reply to the portal-based query as having been received elsewhere']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4277550', 'cui_str': 'Patient Portal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",164205.0,0.190866,"Conclusions and Relevance
Generic patient portal reminders were effective in minimally increasing influenza vaccination rates, but more intensive or more targeted patient motivational strategies appear to be needed.
","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Szilagyi', 'Affiliation': ""Department of Pediatrics, UCLA (University of California, Los Angeles) Mattel Children's Hospital, UCLA.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Albertin', 'Affiliation': ""Department of Pediatrics, UCLA (University of California, Los Angeles) Mattel Children's Hospital, UCLA.""}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Casillas', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, UCLA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Valderrama', 'Affiliation': ""Department of Pediatrics, UCLA (University of California, Los Angeles) Mattel Children's Hospital, UCLA.""}, {'ForeName': 'O Kenrik', 'Initials': 'OK', 'LastName': 'Duru', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, UCLA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Ong', 'Affiliation': 'Department of Medicine, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Vangala', 'Affiliation': 'Department of Medicine Statistics Core, David Geffen School of Medicine, UCLA.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Department of Medicine Statistics Core, David Geffen School of Medicine, UCLA.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Rand', 'Affiliation': 'Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Sharon G', 'Initials': 'SG', 'LastName': 'Humiston', 'Affiliation': ""Department of Pediatrics, Children's Mercy, Kansas City, Missouri.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Evans', 'Affiliation': 'Department of Information Services and Solutions, UCLA Health System, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sloyan', 'Affiliation': 'Department of Information Services and Solutions, UCLA Health System, Los Angeles, California.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Lerner', 'Affiliation': ""Department of Pediatrics, UCLA (University of California, Los Angeles) Mattel Children's Hospital, UCLA.""}]",JAMA internal medicine,['10.1001/jamainternmed.2020.1602']
807,32418164,"Personalized Cognitive Counseling Reduces Drinking Expectancy Among Men Who Have Sex with Men and Transgender Women in Lima, Peru: A Pilot Randomized Controlled Trial.","Personalized cognitive counseling (PCC) is an evidence-based intervention designed to modify HIV-related risk behavior. We assessed the impact of PCC on sexual behavior, drinking expectancy, and incidence of sexually transmitted infections (STIs) in a 6-month randomized controlled trial among 153 HIV-uninfected men who have sex with men (MSM) and transgender women (TW) in Peru. Study retention was ≥ 90%, with three HIV infections (3 Control) and 19 cases of GC/CT (10 Control, 9 PCC) at 6 months. There was a decline in condomless receptive anal intercourse in the Control (0.74, 95% CI 0.60-0.91; p < 0.01) and PCC arms (0.72, 0.55-0.94; p = 0.02) at 6-month follow-up. There was a decrease in drinking expectancy at 6 months among participants endorsing alcohol use in the PCC arm (0.89, 0.83-0.96; p < 0.01), versus no change in the Control arm (0.98, 0.92-1.04; p = 0.54). PCC was efficacious in reducing drinking expectancy and HIV risk among MSM and TW in Peru.",2020,"There was a decline in condomless receptive anal intercourse in the Control (0.74, 95% CI 0.60-0.91; p < 0.01) and PCC arms (0.72, 0.55-0.94; p = 0.02) at 6-month follow-up.","['Who Have Sex with Men and Transgender Women in Lima, Peru', '153 HIV-uninfected men who have sex with men (MSM) and transgender women (TW) in Peru', 'Men']","['Personalized Cognitive Counseling', 'PCC', 'Personalized cognitive counseling (PCC']","['sexual behavior, drinking expectancy, and incidence of sexually transmitted infections (STIs', 'drinking expectancy', 'condomless receptive anal intercourse', 'Drinking Expectancy', 'drinking expectancy and HIV risk']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",153.0,0.085945,"There was a decline in condomless receptive anal intercourse in the Control (0.74, 95% CI 0.60-0.91; p < 0.01) and PCC arms (0.72, 0.55-0.94; p = 0.02) at 6-month follow-up.","[{'ForeName': 'R Colby', 'Initials': 'RC', 'LastName': 'Passaro', 'Affiliation': 'Department of Emergency Medicine, Los Angeles County + University of Southern California Medical Center, Los Angeles, CA, USA. ryan.c.passaro@vanderbilt.edu.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Chávez-Gomez', 'Affiliation': 'Asociación Civil Via Libre, Lima, Peru.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Castañeda-Huaripata', 'Affiliation': 'Asociación Civil Via Libre, Lima, Peru.'}, {'ForeName': 'Williams', 'Initials': 'W', 'LastName': 'Gonzales-Saavedra', 'Affiliation': 'Asociación Civil Via Libre, Lima, Peru.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Beymer', 'Affiliation': 'Department of Community Health Sciences, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Eddy R', 'Initials': 'ER', 'LastName': 'Segura', 'Affiliation': 'South American Program in HIV Prevention Research, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Nanclares', 'Affiliation': 'Alliance Health Project, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dilley', 'Affiliation': 'Department of Psychiatry, University of California San Francisco School of Medicine, San Francisco, CA, USA.'}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Cabello', 'Affiliation': 'Asociación Civil Via Libre, Lima, Peru.'}, {'ForeName': 'Jesse L', 'Initials': 'JL', 'LastName': 'Clark', 'Affiliation': 'South American Program in HIV Prevention Research, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02882-6']
808,32100445,Effect of training provided to patients with chronic obstructive pulmonary disease on drug management.,"AIM
Wrong use of an inhaler arising from a lack of knowledge can negatively affect treatment management. Therefore, this study was performed with the aim of determining the effects on treatment management of inhaler training carried out under the leadership of a nurse in individuals with medium and advanced stage chronic obstructive pulmonary disease (COPD).
METHODS
This was an experimentally designed pre-test post-test study with a control group. Participants were interviewed four times in 1 year. The experimental group performed inhaler training. A Patient Description and Follow-Up Form, an Inhaler Drug Use Skill Chart, the Morisky eight-item Medication Adherence Scale, the COPD Assessment Test, and the St. George Respiration Questionnaire were used to collect data. Data analysis was performed by SPSS, using nonparametric tests.
RESULTS
Although there was no significant difference between the groups, a reduction in hospital visits and admissions because of attacks was seen in the experimental group (p = .239, p = .492). It was found there was a greater increase in the correct use of the inhaler in the experimental group than in the control group, and that correct use of the handihaler increased significantly (p = .008). Also, the increases in adherence to treatment (p = .006) and quality of life (p = .010) in the experimental group were significantly different from the control group. In the control group, the annual decline in forced expiratory volume in 1 s increased significantly (p = .016).
CONCLUSIONS
It was seen that long-term inhaler training given by nurses at regular intervals made a significant contribution to treatment management.",2020,"In the control group, the annual decline in forced expiratory volume in 1 s increased significantly (p = .016).
","['patients with chronic obstructive pulmonary disease on drug management', 'individuals with medium and advanced stage chronic obstructive pulmonary disease (COPD']",[],"['hospital visits and admissions because of attacks', 'correct use', 'quality of life', 'annual decline in forced expiratory volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]",[],"[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034380'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}]",,0.0208525,"In the control group, the annual decline in forced expiratory volume in 1 s increased significantly (p = .016).
","[{'ForeName': 'Sevda', 'Initials': 'S', 'LastName': 'Efil', 'Affiliation': 'Nursing Department, Faculty of Health Sciences, Çanakkale Onsekiz Mart University, Çanakkale, Turkey.'}, {'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Enç', 'Affiliation': 'Department of Internal Diseases Nursing, Cerrahpasa Florence Nightingale Faculty of Nursing, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Turhan', 'Initials': 'T', 'LastName': 'Ece', 'Affiliation': 'Department of Chest Diseases, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12333']
809,32417564,Sham Surgery Studies in Orthopaedic Surgery May Just Be a Sham: A Systematic Review of Randomized Placebo-Controlled Trials.,"PURPOSE
To determine the limitations of randomized sham surgery-controlled trials in orthopaedic sports medicine and fidelity of the trials' conclusions.
METHODS
Randomized placebo surgery-controlled trials in orthopaedic sports medicine were included in this Preferred Reporting Items for Systematic Reviews and Meta-Analyses-guided systematic review. Several aspects of investigation design and conduct were analyzed: genetic analysis for propensity to placebo response, equipoise of informed consent process, geography of trial subjects, percentage of eligible subjects willing to be randomized, changes from protocol publication to results publication, and perioperative complications.
RESULTS
Seven sham surgery-controlled trials (845 subjects [370 knees, 449 shoulders, 26 elbows]; 5 from Europe, 1 from North America, and 1 from Australia; all superiority model, efficacy design) were analyzed. There were consistent methodologic deficiencies across studies. No studies reported genetic analysis of susceptibility to placebo response. Three studies (43%) were underpowered. Crossover rates ranged from 8% to 36%, which led to un-blinding in up to 100% of subjects. There were low enrollment rates of eligible subjects (up to 57% refused randomization). Follow-up was short term (2 years or less in all but one study). Complication rates ranged from 0% to 12.5%, with complications occurring in both groups (no significant difference between groups in any study).
CONCLUSIONS
Randomized sham-controlled studies in orthopaedic sports medicine have significant methodologic deficiencies that may invalidate their conclusions. Randomized trial design (with or without placebo control) may be optimized through the inclusion of per-protocol analysis, blinding index, equivalence or noninferiority trial design, and a nontreatment group.
LEVEL OF EVIDENCE
Level II Systematic Review of Level II studies.",2020,"Complication rates ranged from 0% to 12.5% with complications occurring in both groups (no significant difference between groups in any study).
","['orthopedic sports medicine', 'Seven sham surgery-controlled trials (845 subjects [370 knees, 449 shoulders, 26 elbows]; five Europe, one North America, one Australia', 'Orthopedic Surgery']","['Placebo', 'placebo']",['Complication rates'],"[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}]",845.0,0.715691,"Complication rates ranged from 0% to 12.5% with complications occurring in both groups (no significant difference between groups in any study).
","[{'ForeName': 'Kyle R', 'Initials': 'KR', 'LastName': 'Sochacki', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, Houston, Texas, U.S.A.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Mather', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University School of Medicine, Durham, North Carolina, U.S.A.'}, {'ForeName': 'Benedict U', 'Initials': 'BU', 'LastName': 'Nwachukwu', 'Affiliation': 'Hospital for Special Surgery, New York, New York, U.S.A.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dong', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, Houston, Texas, U.S.A.'}, {'ForeName': 'Shane J', 'Initials': 'SJ', 'LastName': 'Nho', 'Affiliation': 'Section of Young Adult Hip Surgery, Division of Sports Medicine, Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Cote', 'Affiliation': 'UConn Musculoskeletal Institute at UConn Health, Farmington, Connecticut, U.S.A.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Harris', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, Houston, Texas, U.S.A.. Electronic address: joshuaharrismd@gmail.com.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.05.001']
810,31775515,Self-efficacy and response-efficacy: critical components of sexual and reproductive health interventions targeting condom use intention among American Indian adolescents.,"The Respecting the Circle of Life (RCL) intervention is a comprehensive, skills-based sexual/reproductive health program shown to be effective for reducing sexual risk among American Indian (AI) adolescents (13-19 years of age). This paper seeks to identify critical program components of the RCL intervention for replication of impacts on condom use intention (CUI) when scaling to additional communities. RCL was tested among AI adolescents through a cluster randomized controlled trial (N = 267) embedded in an 8-day basketball camp. Data were collected at baseline, immediately post-camp, at 6 and 12 months post-camp. Previously established predictors of CUI that were statistically significantly impacted by RCL at the post-camp time point were tested as mediators of RCL impact on CUI. Condom use self-efficacy and response efficacy fully mediated the effect of RCL on CUI. The indirect path through condom use self-efficacy had the greatest effect on CUI, explaining 79% of the direct effect. When stratified by gender, there was only evidence of mediation among girls. Results indicate condom use self-efficacy and response efficacy are critical components of the RCL intervention for AI girls, and sexual/reproductive health programs should include practical skills training to improve these constructs to maximize intervention impact on CUI.",2020,"The Respecting the Circle of Life (RCL) intervention is a comprehensive, skills-based sexual/reproductive health program shown to be effective for reducing sexual risk among American Indian (AI) adolescents (13-19 years of age).","['American Indian (AI) adolescents (13-19 years of age', 'American Indian adolescents']","['RCL intervention', 'RCL', 'sexual and reproductive health interventions']",[],"[{'cui': 'C0002460', 'cui_str': 'American Indians'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0242667', 'cui_str': 'Reproductive Health'}]",[],,0.0257323,"The Respecting the Circle of Life (RCL) intervention is a comprehensive, skills-based sexual/reproductive health program shown to be effective for reducing sexual risk among American Indian (AI) adolescents (13-19 years of age).","[{'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Rosenstock', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Chambers', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Angelita', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, Johns Hopkins University Bloomberg School of Public Health, Whiteriver, USA.'}, {'ForeName': 'Novalene', 'Initials': 'N', 'LastName': 'Goklish', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, Johns Hopkins University Bloomberg School of Public Health, Whiteriver, USA.'}, {'ForeName': 'Francene', 'Initials': 'F', 'LastName': 'Larzelere', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, Johns Hopkins University Bloomberg School of Public Health, Whiteriver, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Tingey', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, USA.'}]",AIDS care,['10.1080/09540121.2019.1695726']
811,25173802,Modulation of dendritic cell innate and adaptive immune functions by oral and sublingual immunotherapy.,"Sublingual (SLIT) and oral immunotherapy (OIT) are promising treatments for food allergy, but underlying mechanisms are poorly understood. Dendritic cells (DCs) induce and maintain Th2-type allergen-specific T cells, and also regulate innate immunity through their expression of Toll-like receptors (TLRs). We examined how SLIT and OIT influenced DC innate and adaptive immune responses in children with IgE-mediated cow's milk (CM) allergy. SLIT, but not OIT, decreased TLR-induced IL-6 secretion by myeloid DCs (mDCs). SLIT and OIT altered mDC IL-10 secretion, a potent inhibitor of FcεRI-dependent pro-inflammatory responses. OIT uniquely augmented IFN-α and decreased IL-6 secretion by plasmacytoid DCs (pDCs), which was associated with reduced TLR-induced IL-13 release in pDC-T cell co-cultures. Both SLIT and OIT decreased Th2 cytokine secretion to CM in pDC-T, but not mDC-T, co-cultures. Therefore, SLIT and OIT exert unique effects on DC-driven innate and adaptive immune responses, which may inhibit allergic inflammation and promote tolerance.",2014,"OIT uniquely augmented IFN-α and decreased IL-6 secretion by plasmacytoid DCs (pDCs), which was associated with reduced TLR-induced IL-13 release in pDC-T cell co-cultures.","[""children with IgE-mediated cow's milk (CM) allergy""]","['Sublingual (SLIT) and oral immunotherapy (OIT', 'sublingual immunotherapy']","['DC innate and adaptive immune responses', 'TLR-induced IL-6 secretion by myeloid DCs (mDCs', 'Dendritic cells (DCs) induce and maintain Th2-type allergen-specific T cells', 'IL-6 secretion', 'SLIT and OIT altered mDC IL-10 secretion']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0266815', 'cui_str': ""Cow's milk protein sensitivity (disorder)""}]","[{'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}]","[{'cui': 'C1749719', 'cui_str': 'Adaptive Immune Response'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0439677', 'cui_str': 'Myeloid (qualifier value)'}, {'cui': 'C0011306', 'cui_str': 'Dendritic Cells'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0184904', 'cui_str': 'Slitting (procedure)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.0656557,"OIT uniquely augmented IFN-α and decreased IL-6 secretion by plasmacytoid DCs (pDCs), which was associated with reduced TLR-induced IL-13 release in pDC-T cell co-cultures.","[{'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Frischmeyer-Guerrerio', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: pguerrerio@jhmi.edu.'}, {'ForeName': 'Corinne A', 'Initials': 'CA', 'LastName': 'Keet', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: ckeet1@jhmi.edu.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Guerrerio', 'Affiliation': 'Division of Gastroenterology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: aguerrerio@jhmi.edu.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Chichester', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: kchiches@jhmi.edu.'}, {'ForeName': 'Anja P', 'Initials': 'AP', 'LastName': 'Bieneman', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: abienema@jhmi.edu.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hamilton', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: rhamilto@jhmi.edu.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wood', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: rwood@jhmi.edu.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Schroeder', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: schray@jhmi.edu.'}]","Clinical immunology (Orlando, Fla.)",['10.1016/j.clim.2014.08.006']
812,25801652,"Robust and Balanced Immune Responses to All 4 Dengue Virus Serotypes Following Administration of a Single Dose of a Live Attenuated Tetravalent Dengue Vaccine to Healthy, Flavivirus-Naive Adults.","BACKGROUND
The 4 serotypes of dengue virus, DENV-1-4, are the leading cause of arboviral disease globally. The ideal dengue vaccine would provide protection against all serotypes after a single dose.
METHODS
Two randomized, placebo-controlled trials were performed with 168 flavivirus-naive adults to demonstrate the safety and immunogenicity of a live attenuated tetravalent dengue vaccine (TV003), compared with those of a second tetravalent vaccine with an enhanced DENV-2 component (TV005), and to evaluate the benefit of a booster dose at 6 months. Safety data, viremia, and neutralizing antibody titers were evaluated.
RESULTS
A single dose of TV005 elicited a tetravalent response in 90% of vaccinees by 3 months after vaccination and a trivalent response in 98%. Compared with TV003, the higher-dose DENV-2 component increased the observed frequency of immunogenicity to DENV-2 in the TV005 trial. Both the first and second doses were well tolerated. Neither vaccine viremia, rash, nor a significant antibody boost were observed following a second dose.
CONCLUSIONS
A single subcutaneous dose of TV005 dengue vaccine is safe and induces a tetravalent antibody response at an unprecedented frequency among vaccinees. A second dose has limited benefit and appears to be unnecessary. Studies to confirm these findings and assess vaccine efficacy will now move to populations in regions where DENV transmission is endemic.
CLINICAL TRIALS REGISTRATION
NCT01072786 and NCT01436422.",2015,"Neither vaccine viremia, rash, nor a significant antibody boost were observed following a second dose.
","['168 flavivirus-naive adults', 'Healthy, Flavivirus-Naive Adults']","['TV005 dengue vaccine', 'placebo', 'live attenuated tetravalent dengue vaccine (TV003), compared with those of a second tetravalent vaccine with an enhanced DENV-2 component (TV005']","['tolerated', 'tetravalent antibody response', 'Safety data, viremia, and neutralizing antibody titers', 'safety and immunogenicity']","[{'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016215', 'cui_str': 'Arbovirus, Group B'}]","[{'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.183736,"Neither vaccine viremia, rash, nor a significant antibody boost were observed following a second dose.
","[{'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Anna P', 'Initials': 'AP', 'LastName': 'Durbin', 'Affiliation': 'Center for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.'}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Pierce', 'Affiliation': 'Department of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Marya P', 'Initials': 'MP', 'LastName': 'Carmolli', 'Affiliation': 'Department of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Cecilia M', 'Initials': 'CM', 'LastName': 'Tibery', 'Affiliation': 'Center for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.'}, {'ForeName': 'Palmtama L', 'Initials': 'PL', 'LastName': 'Grier', 'Affiliation': 'Center for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.'}, {'ForeName': 'Noreen', 'Initials': 'N', 'LastName': 'Hynes', 'Affiliation': 'Center for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.'}, {'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Diehl', 'Affiliation': 'Department of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Elwood', 'Affiliation': 'Center for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.'}, {'ForeName': 'Adrienne P', 'Initials': 'AP', 'LastName': 'Jarvis', 'Affiliation': 'Department of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Beulah P', 'Initials': 'BP', 'LastName': 'Sabundayo', 'Affiliation': 'Center for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Lyon', 'Affiliation': 'Department of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Larsson', 'Affiliation': 'Department of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jo', 'Affiliation': 'Center for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.'}, {'ForeName': 'Janece M', 'Initials': 'JM', 'LastName': 'Lovchik', 'Affiliation': 'Center for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Luke', 'Affiliation': 'National Institutes of Allergy and Infectious Diseases, Bethesda, Maryland.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Walsh', 'Affiliation': 'Department of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Ellen A', 'Initials': 'EA', 'LastName': 'Fraser', 'Affiliation': 'Department of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.'}, {'ForeName': 'Kanta', 'Initials': 'K', 'LastName': 'Subbarao', 'Affiliation': 'National Institutes of Allergy and Infectious Diseases, Bethesda, Maryland.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Whitehead', 'Affiliation': 'National Institutes of Allergy and Infectious Diseases, Bethesda, Maryland.'}]",The Journal of infectious diseases,['10.1093/infdis/jiv082']
813,32006099,Lunge exercises with blood-flow restriction induces post-activation potentiation and improves vertical jump performance.,"PURPOSE
This study examined the post-activation potentiation effects of body-weight lunge exercises with blood-flow restriction on jump performance. Eighteen anaerobically trained men took part in this study across 3 weeks.
METHODS
During the first week, participants were familiarised with the lunge exercises with blood-flow restriction and the drop-jump protocol. In the second and third week, participants were randomly allocated to complete body-weight lunges (three sets of eight repetitions) either with or without blood-flow restriction (occlusion set at 130% of systolic blood pressure) to induce post-activation potentiation. Drop-jump performance was assessed between blood-flow conditions, and prior to, and at the third, sixth, ninth, twelfth and fifteenth minute following each lunge exercise. Relationships between mechanical contributors of jump performance and final jump performance were examined via Pearson correlation coefficients.
RESULTS
Lunges with blood-flow restriction significantly improved jump height (~ 4.5% ± 0.8%), flight time (~ 3.4% ± 0.3%) and power (~ 4.1% ± 0.3%) within 6-15 min post-exercise (p < 0.05) with the magnitude of effect between blood-flow conditions, moderate-large (0.54-1.16). No significant changes (p > 0.05) were found in jump performance measures following lunge exercises without blood-flow restriction. Significant correlations (p < 0.05) between mechanical contributors of jump performance and jump performance highlighted the potential of blood-flow restriction to enhance stretch-shortening cycle mechanics in the current study.
CONCLUSION
Lunge exercises with blood-flow restriction improved subsequent jump performance in anaerobically trained men. The use of blood-flow restriction may be a practical alternative to heavy resistance training equipment during warm-up protocols.",2020,No significant changes (p > 0.05) were found in jump performance measures following lunge exercises without blood-flow restriction.,"['anaerobically trained men', 'Eighteen anaerobically trained men took part in this study across 3 weeks']","['body-weight lunge exercises with blood-flow restriction', 'Lunge exercises with blood-flow restriction']","['subsequent jump performance', 'jump height', 'jump performance measures', 'jump performance', 'vertical jump performance', 'flight time']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",18.0,0.0107829,No significant changes (p > 0.05) were found in jump performance measures following lunge exercises without blood-flow restriction.,"[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Doma', 'Affiliation': 'James Cook University, Townsville, QLD, Australia. kenji.doma@jcu.edu.au.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Leicht', 'Affiliation': 'James Cook University, Townsville, QLD, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Boullosa', 'Affiliation': 'INISA, Federal University of Mato Grosso do Sul, Campo Grande, Brazil.'}, {'ForeName': 'Carl T', 'Initials': 'CT', 'LastName': 'Woods', 'Affiliation': 'Institute for health and sport, Victoria University, Melbourne, Australia.'}]",European journal of applied physiology,['10.1007/s00421-020-04308-6']
814,32063041,SUPPORT-AF II: Supporting Use of Anticoagulants Through Provider Profiling of Oral Anticoagulant Therapy for Atrial Fibrillation: A Cluster-Randomized Study of Electronic Profiling and Messaging Combined With Academic Detailing for Providers Making Decisions About Anticoagulation in Patients With Atrial Fibrillation.,"BACKGROUND
Previous provider-directed electronic messaging interventions have not by themselves improved anticoagulation use in patients with atrial fibrillation. Direct engagement with providers using academic detailing coupled with electronic messaging may overcome the limitations of the prior interventions.
METHODS AND RESULTS
We randomized outpatient providers affiliated with our health system in a 2.5:1 ratio to our electronic profiling/messaging combined with academic detailing intervention. In the intervention, we emailed providers monthly reports of their anticoagulation percentage relative to peers for atrial fibrillation patients with elevated stroke risk (CHA 2 DS 2 -VASc ≥2). We also sent electronic medical record-based messages shortly before an appointment with an anticoagulation-eligible but untreated atrial fibrillation patient. Providers had the option to send responses with explanations for prescribing decisions. We also offered to meet with intervention providers using an academic detailing approach developed based on knowledge gaps discussed in provider focus groups. To assess feasibility, we tracked provider review of our messages. To assess effectiveness, we measured the change in anticoagulation for patients of intervention providers relative to controls. We identified 85 intervention and 34 control providers taking care of 3591 and 1908 patients, respectively; 33 intervention providers participated in academic detailing. More than 80% of intervention providers read our emails, and 98% of the time a provider reviewed our in-basket messages. Replies to messages identified patient refusal as the most common reason for patients not being on anticoagulation (11.2%). For the group of patients not on anticoagulation at baseline assigned to an intervention versus control provider, the adjusted percent increase in the use of anticoagulation over 6 months was 5.2% versus 7.4%, respectively ( P =0.21).
CONCLUSIONS
Our electronic messaging and academic detailing intervention was feasible but did not increase anticoagulation use. Patient-directed interventions or provider interventions targeting patients declining anticoagulation may be necessary to raise the rate of anticoagulation. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03583008.",2020,"We identified 85 intervention and 34 control providers taking care of 3591 and 1908 patients, respectively; 33 intervention providers participated in academic detailing.","['atrial fibrillation patients with elevated stroke risk (CHA 2 DS 2 -VASc ≥2', 'We randomized outpatient providers affiliated with our health system in a 2.5:1 ratio to our electronic profiling/messaging combined with academic detailing intervention', '34 control providers taking care of 3591 and 1908 patients, respectively; 33 intervention providers participated in academic detailing', 'Patients With Atrial Fibrillation', 'patients with atrial fibrillation', 'Atrial Fibrillation', 'patients of intervention providers relative to controls']","['SUPPORT-AF II', 'Electronic Profiling and Messaging Combined With Academic Detailing for Providers Making Decisions']",[],"[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]",[],,0.098147,"We identified 85 intervention and 34 control providers taking care of 3591 and 1908 patients, respectively; 33 intervention providers participated in academic detailing.","[{'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'University of Massachusetts Memorial Health Care, Worcester (A.K., A.A, E.A., R.E., D.D.M.).'}, {'ForeName': 'Azraa', 'Initials': 'A', 'LastName': 'Amroze', 'Affiliation': 'University of Massachusetts Memorial Health Care, Worcester (A.K., A.A, E.A., R.E., D.D.M.).'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Vakil', 'Affiliation': ""Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, OH (F.V.).""}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Crawford', 'Affiliation': 'University of Massachusetts Medical School, Worcester (A.K., S.C., J.M., E.A., S.J., R.E., A.L., S.N., A.N., K.M.M., J.S.S., D.D.M.).'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Der', 'Affiliation': 'Northeastern University, Boston, MA (J.D., J.S.S.).'}, {'ForeName': 'Jomol', 'Initials': 'J', 'LastName': 'Mathew', 'Affiliation': 'University of Massachusetts Medical School, Worcester (A.K., S.C., J.M., E.A., S.J., R.E., A.L., S.N., A.N., K.M.M., J.S.S., D.D.M.).'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Alper', 'Affiliation': 'University of Massachusetts Memorial Health Care, Worcester (A.K., A.A, E.A., R.E., D.D.M.).'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Yogaratnam', 'Affiliation': 'Mass College of Pharmacy and Health Sciences, Worcester, MA (D.Y., D.B.).'}, {'ForeName': 'Saud', 'Initials': 'S', 'LastName': 'Javed', 'Affiliation': 'University of Massachusetts Medical School, Worcester (A.K., S.C., J.M., E.A., S.J., R.E., A.L., S.N., A.N., K.M.M., J.S.S., D.D.M.).'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Elhag', 'Affiliation': 'University of Massachusetts Memorial Health Care, Worcester (A.K., A.A, E.A., R.E., D.D.M.).'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'University of Massachusetts Medical School, Worcester (A.K., S.C., J.M., E.A., S.J., R.E., A.L., S.N., A.N., K.M.M., J.S.S., D.D.M.).'}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Narayanan', 'Affiliation': 'University of Massachusetts Medical School, Worcester (A.K., S.C., J.M., E.A., S.J., R.E., A.L., S.N., A.N., K.M.M., J.S.S., D.D.M.).'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Bartlett', 'Affiliation': 'Mass College of Pharmacy and Health Sciences, Worcester, MA (D.Y., D.B.).'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Nagy', 'Affiliation': 'University of Massachusetts Medical School, Worcester (A.K., S.C., J.M., E.A., S.J., R.E., A.L., S.N., A.N., K.M.M., J.S.S., D.D.M.).'}, {'ForeName': 'Bevin Kathleen', 'Initials': 'BK', 'LastName': 'Shagoury', 'Affiliation': ""The National Resource Center for Academic Detailing, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA (B.K.S., M.A.F.).""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Fischer', 'Affiliation': ""The National Resource Center for Academic Detailing, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA (B.K.S., M.A.F.).""}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mazor', 'Affiliation': 'University of Massachusetts Medical School, Worcester (A.K., S.C., J.M., E.A., S.J., R.E., A.L., S.N., A.N., K.M.M., J.S.S., D.D.M.).'}, {'ForeName': 'Jane S', 'Initials': 'JS', 'LastName': 'Saczynski', 'Affiliation': 'University of Massachusetts Medical School, Worcester (A.K., S.C., J.M., E.A., S.J., R.E., A.L., S.N., A.N., K.M.M., J.S.S., D.D.M.).'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Ashburner', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston (J.M.A.).'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (R.L.).'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'McManus', 'Affiliation': 'University of Massachusetts Memorial Health Care, Worcester (A.K., A.A, E.A., R.E., D.D.M.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.005871']
815,31517512,"An Intervention to Reduce Hypoglycemia Fear in Parents of Young Kids with Type 1 Diabetes Through Video-Based Telemedicine (REDCHiP): Trial Design, Feasibility, and Acceptability.","Background: Fear of hypoglycemia (FH) is common in parents of young children with type 1 diabetes (T1D) and problematically linked to maladaptive behaviors to avoid low blood glucose, parenting stress, and burnout. This study examined the feasibility and acceptability of a novel group-based telemedicine intervention to reduce FH in parents of young children with T1D. Materials and Methods: Forty-three families of a young child with T1D (1-6 years of age; diagnosed with T1D for at least 6 months) enrolled in the study and 36 completed the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention. We assessed intervention feasibility with rates of attrition, intervention attendance, and fidelity to the treatment manual. We assessed acceptability with treatment satisfaction surveys and qualitative interviews (from a subset of completers; n = 10) about intervention acceptability, facilitators, and challenges. Results: Study attrition was 21%, including long-term follow-up (16% before or during the treatment phase). On average, parents attended 94% of intervention sessions and fidelity to the treatment manual was 89%. Intervention completers reported high satisfaction with the treatment groups (89% average satisfaction rating). Parent-reported positive influencers of the REDCHiP intervention were increased knowledge, fear awareness, coping strategies, confidence, behavioral parenting strategies, and support, whereas intervention challenges included feeling fearful or overwhelmed, family stress, lack of trust, and difficulty connecting with other group members. Conclusions: The REDCHiP intervention demonstrated initial feasibility and acceptability. Next steps include determining the intervention's impact on objective parent and child outcomes (e.g., glycemic control, parental FH, and parental stress/distress) as well as large-scale efficacy testing.",2020,"Parent-reported positive influencers of the REDCHiP intervention were increased knowledge, fear awareness, coping strategies, confidence, behavioral parenting strategies, and support; whereas intervention challenges included feeling fearful or overwhelmed, family stress, lack of trust, and difficulty connecting with other group members.
","['parents of young children with type 1 diabetes (T1D', 'Parents of Young Kids with Type 1 Diabetes via', 'parents of young children with T1D.\nMETHODS\n\n\nForty-three families of a young child with T1D (1-6 years old; diagnosed with T1D for at least 6 months) enrolled in the study and 36 completed the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention']","['REDCHiP intervention', 'Video-Based Telemedicine (REDCHIP', 'novel group-based telemedicine intervention']","['feeling fearful or overwhelmed, family stress, lack of trust, and difficulty connecting', 'Hypoglycemia Fear', 'knowledge, fear awareness, coping strategies, confidence, behavioral parenting strategies, and support', 'objective parent and child outcomes (e.g., glycemic control, parental FH, parental stress/distress) as well as large-scale efficacy testing', 'initial feasibility and acceptability', 'feasibility and acceptability']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0577730', 'cui_str': 'Family tension (finding)'}, {'cui': 'C3875092', 'cui_str': 'Lack of trust'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",43.0,0.0234171,"Parent-reported positive influencers of the REDCHiP intervention were increased knowledge, fear awareness, coping strategies, confidence, behavioral parenting strategies, and support; whereas intervention challenges included feeling fearful or overwhelmed, family stress, lack of trust, and difficulty connecting with other group members.
","[{'ForeName': 'Arwen M', 'Initials': 'AM', 'LastName': 'Marker', 'Affiliation': 'Clinical Child Psychology Program, University of Kansas, Lawrence, Kansas.'}, {'ForeName': 'Alexandra D', 'Initials': 'AD', 'LastName': 'Monzon', 'Affiliation': 'Clinical Child Psychology Program, University of Kansas, Lawrence, Kansas.'}, {'ForeName': 'Eve-Lynn', 'Initials': 'EL', 'LastName': 'Nelson', 'Affiliation': ""Center for Children's Healthy Lifestyles and Nutrition, Children's Mercy Kansas City, Kansas City, Missouri.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Clements', 'Affiliation': ""Center for Children's Healthy Lifestyles and Nutrition, Children's Mercy Kansas City, Kansas City, Missouri.""}, {'ForeName': 'Susana R', 'Initials': 'SR', 'LastName': 'Patton', 'Affiliation': ""Center for Children's Healthy Lifestyles and Nutrition, Children's Mercy Kansas City, Kansas City, Missouri.""}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0244']
816,23329850,"A single dose of any of four different live attenuated tetravalent dengue vaccines is safe and immunogenic in flavivirus-naive adults: a randomized, double-blind clinical trial.","BACKGROUND
Dengue virus (DENV) causes hundreds of millions of infections annually. Four dengue serotypes exist, and previous infection with one serotype increases the likelihood of severe disease with a second, heterotypic DENV infection.
METHODS
In a randomized, placebo-controlled study, the safety and immunogenicity of 4 different admixtures of a live attenuated tetravalent (LATV) dengue vaccine were evaluated in 113 flavivirus-naive adults. Serum neutralizing antibody levels to all 4 dengue viruses were measured on days 0, 28, 42, and 180.
RESULTS
A single dose of each LATV admixture induced a trivalent or better neutralizing antibody response in 75%-90% of vaccinees. There was no significant difference in the incidence of adverse events between vaccinees and placebo-recipients other than rash. A trivalent or better response correlated with rash and with non-black race (P < .0001). Black race was significantly associated with a reduced incidence of vaccine viremia.
CONCLUSIONS
TV003 induced a trivalent or greater antibody response in 90% of flavivirus-naive vaccinees and is a promising candidate for the prevention of dengue. Race was identified as a factor influencing the infectivity of the LATV viruses, reflecting observations of the effect of race on disease severity in natural dengue infection.",2013,There was no significant difference in the incidence of adverse events between vaccinees and placebo-recipients other than rash.,"['113 flavivirus-naive adults', 'flavivirus-naive adults']","['4 different admixtures of a live attenuated tetravalent (LATV) dengue vaccine', 'placebo']","['Serum neutralizing antibody levels', 'safety and immunogenicity', 'incidence of adverse events', 'antibody response', 'neutralizing antibody response']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016215', 'cui_str': 'Arbovirus, Group B'}]","[{'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}]",,0.388905,There was no significant difference in the incidence of adverse events between vaccinees and placebo-recipients other than rash.,"[{'ForeName': 'Anna P', 'Initials': 'AP', 'LastName': 'Durbin', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 624 N Broadway, Rm 217, Baltimore, MD 21205, USA. adurbin@jhsph.edu'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': ''}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Pierce', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Elwood', 'Affiliation': ''}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Larsson', 'Affiliation': ''}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'Lindow', 'Affiliation': ''}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Tibery', 'Affiliation': ''}, {'ForeName': 'Beulah P', 'Initials': 'BP', 'LastName': 'Sabundayo', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shaffer', 'Affiliation': ''}, {'ForeName': 'Kawsar R', 'Initials': 'KR', 'LastName': 'Talaat', 'Affiliation': ''}, {'ForeName': 'Noreen A', 'Initials': 'NA', 'LastName': 'Hynes', 'Affiliation': ''}, {'ForeName': 'Kimberli', 'Initials': 'K', 'LastName': 'Wanionek', 'Affiliation': ''}, {'ForeName': 'Marya P', 'Initials': 'MP', 'LastName': 'Carmolli', 'Affiliation': ''}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Luke', 'Affiliation': ''}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Kanta', 'Initials': 'K', 'LastName': 'Subbarao', 'Affiliation': ''}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Whitehead', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jis936']
817,24189371,Durable antibody responses following one dose of the bivalent human papillomavirus L1 virus-like particle vaccine in the Costa Rica Vaccine Trial.,"The Costa Rica HPV16/18 Vaccine Trial (CVT) showed that four-year vaccine efficacy against 12-month HPV16/18 persistent infection was similarly high among women who received one, two, or the recommended three doses of the bivalent HPV16/18 L1 virus-like particle (VLP) vaccine. Live-attenuated viral vaccines, but not simple-subunit vaccines, usually induce durable lifelong antibody responses after a single dose. It is unclear whether noninfectious VLP vaccines behave more like live-virus or simple-subunit vaccines in this regard. To explore the likelihood that efficacy will persist longer term, we investigated the magnitude and durability of antibodies to this vaccine by measuring HPV16- and HPV18-specific antibodies by VLP-ELISA using serum from enrollment, vaccination, and annual visits through four years in four vaccinated groups; one-dose (n = 78), two-doses separated by one month (n = 140), two doses separated by six months (n = 52), and three scheduled doses (n = 120, randomly selected). We also tested enrollment sera from n = 113 HPV16- or HPV18 L1-seropositive women prevaccination, presumably from natural infection. At four years, 100% of women in all groups remained HPV16/18 seropositive; both HPV16/18 geometric mean titers (GMT) among the extended two-dose group were non-inferior to the three-dose group, and ELISA titers were highly correlated with neutralization titers in all groups. Compared with the natural infection group, HPV16/18 GMTs were, respectively, at least 24 and 14 times higher among the two-dose and 9 and 5 times higher among one-dose vaccinees. Antibody levels following one-dose remained stable from month 6 through month 48. Results raise the possibility that even a single dose of HPV VLPs will induce long-term protection.",2013,"At four years, 100% of women in all groups remained HPV16/18 seropositive; both HPV16/18 geometric mean titers (GMT) among the extended two-dose group were non-inferior to the three-dose group, and ELISA titers were highly correlated with neutralization titers in all groups.",['n = 113'],['bivalent HPV16/18 L1 virus-like particle (VLP) vaccine'],"['Antibody levels', 'ELISA titers', 'Durable antibody responses', 'HPV16/18 geometric mean titers (GMT']",[],"[{'cui': 'C2936379', 'cui_str': 'Vaccines, Virus-Like Particle'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",140.0,0.0578844,"At four years, 100% of women in all groups remained HPV16/18 seropositive; both HPV16/18 geometric mean titers (GMT) among the extended two-dose group were non-inferior to the three-dose group, and ELISA titers were highly correlated with neutralization titers in all groups.","[{'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Safaeian', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, Infections and Immunoepidemiology Branch, National Cancer Institute, 9609 Medical Center Drive, Rm 6-E224, MSC 9767, Bethesda, MD 20892. safaeianm@mail.nih.gov.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Porras', 'Affiliation': ''}, {'ForeName': 'Yuanji', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Kreimer', 'Affiliation': ''}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Schiller', 'Affiliation': ''}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Gonzalez', 'Affiliation': ''}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Lowy', 'Affiliation': ''}, {'ForeName': 'Sholom', 'Initials': 'S', 'LastName': 'Wacholder', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Schiffman', 'Affiliation': ''}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Rodriguez', 'Affiliation': ''}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Herrero', 'Affiliation': ''}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Kemp', 'Affiliation': ''}, {'ForeName': 'Gloriana', 'Initials': 'G', 'LastName': 'Shelton', 'Affiliation': ''}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Quint', 'Affiliation': ''}, {'ForeName': 'Leen-Jan', 'Initials': 'LJ', 'LastName': 'van Doorn', 'Affiliation': ''}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hildesheim', 'Affiliation': ''}, {'ForeName': 'Ligia A', 'Initials': 'LA', 'LastName': 'Pinto', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-13-0203']
818,32427228,Squeeze bottle versus syringe nasal saline irrigation for persistent allergic rhinitis - a randomized controlled trial.,"BACKGROUND
Nasal irrigation is widely used as an adjunctive treatment for allergic rhinitis. There is little evidence regarding the efficacy of the devices used in this procedure. The objective of this study was to evaluate the efficacy of the squeeze bottle nasal saline irrigation in persistent allergic rhinitis patients compared with a syringe.
METHODOLOGY
We included patients between 18- and 60-years old presenting with persistent allergic rhinitis. All patients were instructed to perform nasal irrigation twice daily for four weeks. The patients were randomly assigned to use either the squeeze bottle nasal irrigation or a syringe for nasal irrigation. Symptoms score, physical examination results, satisfaction scores and adverse events were collected.
RESULTS
There were 116 patients enrolled in the study, 58 of whom used the squeeze bottle nasal irrigation system and 58 of whom used a syringe. During a four-week follow-up, improvements in patients' nasal symptom scores for rhinitis symptoms were significantly greater in the group treated with the squeeze bottle. However, the physical examination score was no statistically significant difference. No adverse events were reported. The overall satisfaction scores for both devices were excellent.
CONCLUSIONS
This study supports the regular use of nasal irrigation with a positive-pressure device, particularly a squeeze bottle, as an effective adjunctive treatment for allergic rhinitis. It is effective for reducing allergic rhinitis symptoms and can be used by patients with good compliance and minimal side effects.",2020,"During a four-week follow-up, improvements in patients' nasal symptom scores for rhinitis symptoms were significantly greater in the group treated with the squeeze bottle.","['allergic rhinitis', '116 patients enrolled in the study, 58 of whom used the squeeze bottle nasal irrigation system and 58 of whom used a syringe', 'persistent allergic rhinitis patients', 'patients between 18- and 60-years old presenting with persistent allergic rhinitis']","['squeeze bottle nasal irrigation or a syringe for nasal irrigation', 'Squeeze bottle versus syringe nasal saline irrigation', 'squeeze bottle nasal saline irrigation']","[""patients' nasal symptom scores for rhinitis symptoms"", 'allergic rhinitis symptoms', 'adverse events', 'physical examination score', 'Symptoms score, physical examination results, satisfaction scores and adverse events', 'overall satisfaction scores']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",116.0,0.0416316,"During a four-week follow-up, improvements in patients' nasal symptom scores for rhinitis symptoms were significantly greater in the group treated with the squeeze bottle.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Piromchai', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kasemsiri', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Reechaipichitkul', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}]",Rhinology,['10.4193/Rhin19.308']
819,31541718,Changes in Pain-Related Fear and Pain When Avoidance Behavior is no Longer Effective.,"Avoidance is considered key in the development of chronic pain. However, little is known about how avoidance behavior subsequently affects pain-related fear and pain. We investigated this using a robotic arm reaching avoidance task. In a between-subjects design both Experimental Group (n = 30) and Yoked Control Group (n = 30) participants perform either of 3 movement trajectories (T1-T3) to reach a target location. During acquisition, only participants of the Experimental Group could partially or fully avoid a painful electrocutaneous stimulus by choosing the intermediate trajectory (T2; 50% reinforcement) or the longest trajectory (T3; 0% reinforcement) versus the shortest trajectory (T1: 100% reinforcement). After acquisition, contingencies changed (all trajectories 50% reinforced), and the acquired avoidance behavior no longer effectively prevented pain from occurring. The Yoked Control Group received the same reinforcement schedule as the Experimental Group irrespective of their behavior. When avoidance behavior became ineffective for the Experimental Group, pain-related fear increased for the previously safe(r) trajectories (T2 and T3) and remained the same for T1, whereas pain threshold and tolerance declined. For the Yoked Group, pain-related fear increased for all trajectories. The Experimental Group persisted in emitting avoidance behavior following the contingency change, albeit at a lower frequency than during acquisition. PERSPECTIVE: Results indicate participants become more afraid of and sensitive to pain, when previously acquired avoidance is no longer effective. Also, participants continue to show avoidance behavior despite it being not adaptive anymore. These findings suggest that ineffective avoidance may play role in the maintenance and development of chronic pain.",2020,"When avoidance behaviour became ineffective for the Experimental Group, pain-related fear increased for the previously safe(r) trajectories (T2 and T3) and remained the same for T1, whereas pain threshold and tolerance declined.",[],[],"['pain-related fear and pain', 'pain-related fear', 'pain', 'emitting avoidance behaviour']",[],[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0178494', 'cui_str': 'Avoidance Behavior'}]",,0.0424807,"When avoidance behaviour became ineffective for the Experimental Group, pain-related fear increased for the previously safe(r) trajectories (T2 and T3) and remained the same for T1, whereas pain threshold and tolerance declined.","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'van Vliet', 'Affiliation': 'Research Group Health Psychology, KU Leuven, Leuven, Belgium; Experimental Health Psychology, Maastricht University, Maastricht, The Netherlands. Electronic address: christine.vanvliet@kuleuven.be.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Meulders', 'Affiliation': 'Research Group Health Psychology, KU Leuven, Leuven, Belgium; Experimental Health Psychology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Linda M G', 'Initials': 'LMG', 'LastName': 'Vancleef', 'Affiliation': 'Experimental Health Psychology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Meyers', 'Affiliation': 'Research Group Health Psychology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Johan W S', 'Initials': 'JWS', 'LastName': 'Vlaeyen', 'Affiliation': 'Research Group Health Psychology, KU Leuven, Leuven, Belgium; Experimental Health Psychology, Maastricht University, Maastricht, The Netherlands.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.09.002']
820,31993658,A Pilot Randomized Controlled Trial of Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women.,"INTRODUCTION
The majority of women who smoke cigarettes report that concern about weight gain is a barrier to quitting. We developed an intervention incorporating distress tolerance, appetite awareness, and mindful eating skills to target concerns about post-cessation weight gain and emotional eating (DT-W). In the current study, we conducted a pilot randomized controlled trial of DT-W versus a smoking health education (HE) intervention.
METHODS
Participants (N = 69 adult female, weight-concerned smokers) were recruited in cohorts of 4-11. Cohorts were randomized to DT-W or HE. DT-W and HE were matched on format (single individual session followed by eight group sessions), inclusion of cognitive behavioral therapy for smoking cessation (CBT) content, and pharmacotherapy (nicotine patches). Follow-up assessments occurred at 1-, 3-, and 6-months post-treatment.
RESULTS
The recruitment goal was met; 61 of the 69 participants attended at least one group session. There were no significant differences between DT-W and HE in the number of group sessions attended (DT-W adjusted M = 5.09, HE adjusted M = 5.03, p = .92), ratings of treatment effectiveness or usefulness of skills, or retention at 6-month follow-up (79% in DT-W vs. 78% in HE) (ps > .05), but comprehension ratings were lower in DT-W than in HE (p = .02).
CONCLUSIONS
Overall, these results suggest that the study procedures and interventions were feasible and acceptable, but changes to the DT-W intervention content to improve comprehension should be considered prior to conducting a fully powered trial.
IMPLICATIONS
A distress tolerance-based treatment targeting fear of weight gain after smoking cessation and post-cessation emotional eating was feasible and acceptable relative to a smoking HE comparison condition, but changes should be considered before conducting a larger trial. Continued innovation in treatment development for weight-concerned smokers is needed.",2020,"There were no significant differences between DT-W and HE in the number of group sessions attended (DT-W adjusted M = 5.09, HE adjusted M = 5.03, p = .92), ratings of treatment effectiveness or usefulness of skills, or retention at 6-month follow-up (79% in DT-W vs. 78% in HE)","['Smoking Cessation Among Women', 'Participants (N = 69 adult female, weight-concerned smokers']","['Distress Tolerance Treatment', 'DT-W vs. a smoking health education (HE) intervention', 'cognitive-behavioral therapy for smoking cessation (CBT) content, and pharmacotherapy (nicotine patches']","['DT-W and HE', 'distress tolerance, appetite awareness, and mindful eating skills to target concerns about post-cessation weight gain and emotional eating (DT-W', 'ratings of treatment effectiveness or usefulness of skills, or retention', 'comprehension ratings']","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0971308', 'cui_str': 'DT-W(IV)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0018701'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}]","[{'cui': 'C0971308', 'cui_str': 'DT-W(IV)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",69.0,0.0749398,"There were no significant differences between DT-W and HE in the number of group sessions attended (DT-W adjusted M = 5.09, HE adjusted M = 5.03, p = .92), ratings of treatment effectiveness or usefulness of skills, or retention at 6-month follow-up (79% in DT-W vs. 78% in HE)","[{'ForeName': 'Erika Litvin', 'Initials': 'EL', 'LastName': 'Bloom', 'Affiliation': 'Departments of Psychiatry and Human Behavior and Medicine, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Ramsey', 'Affiliation': 'Departments of Psychiatry and Human Behavior and Medicine, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Abrantes', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hunt', 'Affiliation': 'Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Molino', 'Affiliation': 'Department of Orthopaedics, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Brown', 'Affiliation': 'University of Texas at Austin School of Nursing, Austin, TX.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa026']
821,32493213,Comparison of gastric insufflation using LMA-supreme and I-gel versus tracheal intubation in laparoscopic gynecological surgery by ultrasound: a randomized observational trial.,"BACKGROUND
The application of bedside ultrasound to evaluate gastric content and volume can assist in determining aspiration risk. Applying positive pressure ventilation via supraglottic airway devices (SAD) can result in a degree of gastric insufflation. This study assessed and compared the antral cross-sectional area (CSA) in patients undergoing laparoscopic gynecological surgery when managed with different SAD.
METHODS
One hundred American Society of Anesthesiologists I or II female patients were assessed for inclusion in this study and divided into three groups of different ventilation devices. Patients were randomly allocated into three groups to receive LMA-Supreme (Group S), I-gel (Group I) or tracheal tube (Group T). The primary outcome was the antral cross-sectional area and secondary outcomes included haemodynamic parameters and postoperative morbidity such as sore throat, hoarseness, dry throat, nausea and vomiting.
RESULTS
The antral CSA was not significantly different among three groups before induction (P = 0.451), after induction (P = 0.456) and at the end of surgery (P = 0.195). The haemodynamic variables were significantly higher in the tracheal tube group than in the LMA-Supreme and I-gel groups after insertion (P < 0.0001) and after removal (P < 0.01). Sore throat was detected in none in the I-gel group compare to two patients (6.7%) in the LMA-Supreme group and fifteen patients (50%) in the tracheal tube group. Hoareness was detected in one (3.3%) in the I-gel group compare to two patients (6.7%) in the LMA-Supreme group and eleven patients (36.7%) in the tracheal tube group.
CONCLUSIONS
The SADs do not cause obvious gastric insufflation. Thus, LMA-Supreme and I-gel can be widely used as alternative to endotracheal intubation for the short laparoscopic gynecological surgery.
TRIAL REGISTRATION
This trial was registered at the Chinese Clinical Trial Registry (ChiCTR1800018212, data of registration, September 2018).",2020,The haemodynamic variables were significantly higher in the tracheal tube group than in the LMA-Supreme and I-gel groups after insertion (P < 0.0001) and after removal (P < 0.01).,"['One hundred American Society of Anesthesiologists', 'laparoscopic gynecological surgery by ultrasound', 'I or II female patients', 'patients undergoing laparoscopic gynecological surgery when managed with different SAD']","['LMA-Supreme (Group S), I-gel (Group I) or tracheal tube', 'positive pressure ventilation via supraglottic airway devices (SAD', 'LMA-supreme and I-gel versus tracheal intubation']","['antral cross-sectional area and secondary outcomes included haemodynamic parameters and postoperative morbidity such as sore throat, hoarseness, dry throat, nausea and vomiting', 'haemodynamic variables', 'Hoareness', 'Sore throat', 'antral CSA']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C1260970', 'cui_str': 'Tracheal tube'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0235234', 'cui_str': 'Pharyngeal dryness'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",100.0,0.131033,The haemodynamic variables were significantly higher in the tracheal tube group than in the LMA-Supreme and I-gel groups after insertion (P < 0.0001) and after removal (P < 0.01).,"[{'ForeName': 'Qiuping', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, No.218 Jixi Road, Hefei, 230022, Anhui Province, People's Republic of China.""}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, No.218 Jixi Road, Hefei, 230022, Anhui Province, People's Republic of China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, No.218 Jixi Road, Hefei, 230022, Anhui Province, People's Republic of China.""}, {'ForeName': 'Gordon Tin Chun', 'Initials': 'GTC', 'LastName': 'Wong', 'Affiliation': ""Department of Anesthesiology, The University of Hong Kong, Hong Kong SAR, People's Republic of China.""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, No.218 Jixi Road, Hefei, 230022, Anhui Province, People's Republic of China. luyao-mz@163.com.""}]",BMC anesthesiology,['10.1186/s12871-020-01057-z']
822,32423247,Effect of Nasal Steroids on Nasal Obstruction in Septal Deviation: A Double-Blind Randomized Controlled Trial.,"Objective: This study sought to prospectively determine the effect of intranasal steroids versus placebo on nasal obstruction in septal deviation. Methods: This was a single-center randomized placebo-controlled double-blind trial with crossover in which all study participants received 6 weeks of therapy with Nasacort (Chattem, Inc.) and with Ayr saline spray (B.F. Ascher). Participants were randomized to one of two groups with a 2-week washout period between drugs. Nasal Obstruction Symptom Evaluation (NOSE) scores were collected at baseline and after each study drug. A subset of patients subsequently underwent surgical intervention after both drugs and additional NOSE scores were collected postoperatively. Results: Forty-two patients completed both study drugs with NOSE scores collected. Thirty-two patients underwent surgery and postoperative NOSE scores were collected. There was no significant difference in baseline demographics between the groups. There was no significant difference in mean NOSE scores in either group from baseline to the completion of the first and second study drugs. There was no difference in the change in mean NOSE score from baseline to postsaline (-3.9) versus baseline to poststeroid (-5.8, p = 0.60). Surgery resulted in a significant change in NOSE score at all postoperative time points (mean of -50, range of -47.2 to -53.6). Conclusions: We found no significant effect of intranasal steroids on nasal obstruction as compared with placebo. Surgery, however, was associated with significant sustained improvement in nasal obstruction. These data suggest that in patients with nasal obstruction due to a fixed cause, medical therapy with intranasal steroids is unlikely to be beneficial.",2020,There was no significant difference in mean NOSE scores in either group from baseline to the completion of the first and second study drugs.,"['Nasal Obstruction in Septal Deviation', 'patients with nasal obstruction', 'Results: Forty-two patients completed both study drugs with NOSE scores collected']","['intranasal steroids', 'intranasal steroids versus placebo', 'Nasal Steroids', 'therapy with Nasacort (Chattem, Inc.) and with Ayr saline spray (B.F. Ascher', 'placebo']","['mean NOSE scores', 'mean NOSE score', 'NOSE score', 'baseline demographics', 'Nasal Obstruction Symptom Evaluation (NOSE) scores', 'nasal obstruction', 'postoperative NOSE scores']","[{'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0549397', 'cui_str': 'Deviated nasal septum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0594040', 'cui_str': 'Nasacort'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C3494438', 'cui_str': 'Symptom Evaluation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",42.0,0.347848,There was no significant difference in mean NOSE scores in either group from baseline to the completion of the first and second study drugs.,"[{'ForeName': 'Shannon F', 'Initials': 'SF', 'LastName': 'Rudy', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Cherian', 'Initials': 'C', 'LastName': 'Kandathil', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Spataro', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Sami P', 'Initials': 'SP', 'LastName': 'Moubayed', 'Affiliation': 'Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Montreal, Montréal, Canada.'}, {'ForeName': 'Sam P', 'Initials': 'SP', 'LastName': 'Most', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, USA.'}]",Facial plastic surgery & aesthetic medicine,['10.1089/fpsam.2020.0150']
823,32422066,Effect of Acupuncture for Postprandial Distress Syndrome: A Randomized Clinical Trial.,"BACKGROUND
Postprandial distress syndrome (PDS) is the most common subtype of functional dyspepsia. Acupuncture is commonly used to treat PDS, but its effect is uncertain because of the poor quality of prior studies.
OBJECTIVE
To assess the efficacy of acupuncture versus sham acupuncture in patients with PDS.
DESIGN
Multicenter, 2-group, randomized clinical trial. (ISRCTN registry number: ISRCTN12511434).
SETTING
5 tertiary hospitals in China.
PARTICIPANTS
Chinese patients aged 18 to 65 years meeting Rome IV criteria for PDS.
INTERVENTION
12 sessions of acupuncture or sham acupuncture over 4 weeks.
MEASUREMENTS
The 2 primary outcomes were the response rate based on overall treatment effect and the elimination rate of all 3 cardinal symptoms: postprandial fullness, upper abdominal bloating, and early satiation after 4 weeks of treatment. Participants were followed until week 16.
RESULTS
Among the 278 randomly assigned participants, 228 (82%) completed outcome measurements at week 16. The estimated response rate from generalized linear mixed models at week 4 was 83.0% in the acupuncture group versus 51.6% in the sham acupuncture group (difference, 31.4 percentage points [95% CI, 20.3 to 42.5 percentage points]; P < 0.001). The estimated elimination rate of all 3 cardinal symptoms was 27.8% in the acupuncture group versus 17.3% in the sham acupuncture group (difference, 10.5 percentage points [CI, 0.08 to 20.9 percentage points]; P = 0.034). The efficacy of acupuncture was maintained during the 12-week posttreatment follow-up. There were no serious adverse events.
LIMITATION
Lack of objective outcomes and daily measurement, high dropout rate, and inability to blind acupuncturists.
CONCLUSION
Among patients with PDS, acupuncture resulted in increased response rate and elimination rate of all 3 cardinal symptoms compared with sham acupuncture, with sustained efficacy over 12 weeks in patients who received thrice-weekly acupuncture for 4 weeks.
PRIMARY FUNDING SOURCE
Beijing Municipal Science and Technology Commission.",2020,"The estimated response rate from generalized linear mixed models at week 4 was 83.0% in the acupuncture group versus 51.6% in the sham acupuncture group (difference, 31.4 percentage points [95% CI, 20.3 to 42.5 percentage points]; ","['5 tertiary hospitals in China', 'Chinese patients aged 18 to 65 years meeting Rome IV criteria for PDS', 'patients with PDS', 'Postprandial Distress Syndrome', '278 randomly assigned participants, 228 (82%) completed outcome measurements at week 16']","['acupuncture', 'acupuncture versus sham acupuncture', 'acupuncture or sham acupuncture', 'Acupuncture', 'sham acupuncture']","['response rate based on overall treatment effect and the elimination rate of all 3 cardinal symptoms: postprandial fullness, upper abdominal bloating, and early satiation', 'elimination rate of all 3 cardinal symptoms', 'response rate and elimination rate']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0326926', 'cui_str': 'Cardinalis cardinalis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}]",278.0,0.617612,"The estimated response rate from generalized linear mixed models at week 4 was 83.0% in the acupuncture group versus 51.6% in the sham acupuncture group (difference, 31.4 percentage points [95% CI, 20.3 to 42.5 percentage points]; ","[{'ForeName': 'Jing-Wen', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).'}, {'ForeName': 'Shi-Yan', 'Initials': 'SY', 'LastName': 'Yan', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China (S.Y.).'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China (Y.W., J.T.).'}, {'ForeName': 'Jing-Jie', 'Initials': 'JJ', 'LastName': 'Zhao', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University, Beijing, China (J.Z., Y.D.).'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China (Y.W., J.T.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (J.W.).'}, {'ForeName': 'Guang-Xia', 'Initials': 'GX', 'LastName': 'Shi', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China (H.H.).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Huguosi Hospital of Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China (W.Z.).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University, Beijing, China (J.Z., Y.D.).'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, and Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China (C.L.).'}]",Annals of internal medicine,['10.7326/M19-2880']
824,32115392,Clinical pharmacists in diabetes management: What do minority patients with uncontrolled diabetes have to say?,"OBJECTIVE
Clinical pharmacist support for patients with type 2 diabetes mellitus (T2DM) can optimize patient outcomes and medication adherence. However, there is limited understanding of what pharmacist roles patients perceive as most helpful in T2DM management interventions. This study describes experiences of minority patients with uncontrolled T2DM in terms of perceived pharmacist helpfulness and specific roles found to be most helpful within diabetes management.
DESIGN
A secondary analysis of a 2-year randomized, crossover trial was conducted.
SETTING AND PARTICIPANTS
This study included 244 African American and Hispanic adults with uncontrolled T2DM who received clinical pharmacist support within a team-based model.
OUTCOME MEASURES
The patients completed a mixed-methods survey regarding their experience with the intervention that included a general helpfulness rating on a 10-point unipolar Likert scale and described the support qualitatively, including their perception of the pharmacist roles. Thematic analysis guided coding of the responses.
RESULTS
One hundred forty-seven (60%) patients completed the survey and had at least 1 encounter with a clinical pharmacist. Of these, 108 (74%) were African American, 39 (27%) were Hispanic, and 101 (69%) were women. The median rating of clinical pharmacist helpfulness was 10 (very helpful). Only 10 (7%) participants rated pharmacist helpfulness as 1 (not at all helpful). ""Medication education and management"" was the most frequently perceived supportive role of the clinical pharmacists, followed by ""non-medication-related patient education,"" ""social support,"" and ""care coordination."" Miscommunication related to scheduling was the most common reason cited for not meeting with the clinical pharmacist.
CONCLUSION
This sample of minority patients with uncontrolled T2DM recognized many roles outlined within the American Pharmacists Association Medication Therapy Management framework. Patient experiences with clinical pharmacist T2DM support are crucial for developing effective programs, maximizing patient engagement, satisfying patient needs, and ensuring that a program's intended purpose aligns with the patient perspective.",2020,"Medication education and management"" was the most frequently perceived supportive role of the clinical pharmacists, followed by ""non-medication-related patient education,"" ""social support,"" and ""care coordination.""","['minority patients with uncontrolled T2DM', '108 (74%) were African American, 39 (27%) were Hispanic, and 101 (69%) were women', 'minority patients with uncontrolled diabetes', '244 African American and Hispanic adults with uncontrolled T2DM who received clinical pharmacist support within a team-based model', 'One hundred forty-seven (60%) patients completed the survey and had at least 1 encounter with a clinical pharmacist', 'patients with type 2 diabetes mellitus (T2DM']",[],"['pharmacist helpfulness', 'median rating of clinical pharmacist helpfulness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1449564', 'cui_str': 'Clinical Pharmacists'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1449564', 'cui_str': 'Clinical Pharmacists'}]",244.0,0.0432504,"Medication education and management"" was the most frequently perceived supportive role of the clinical pharmacists, followed by ""non-medication-related patient education,"" ""social support,"" and ""care coordination.""","[{'ForeName': 'Nadia A', 'Initials': 'NA', 'LastName': 'Nabulsi', 'Affiliation': ''}, {'ForeName': 'Connie H', 'Initials': 'CH', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Tilton', 'Affiliation': ''}, {'ForeName': 'Ben S', 'Initials': 'BS', 'LastName': 'Gerber', 'Affiliation': ''}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Sharp', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2020.01.024']
825,32083653,Intraoperative localization of cardiac conduction tissue regions using real-time fibre-optic confocal microscopy: first in human trial.,"OBJECTIVES
The aim of this study was to evaluate the feasibility and safety of fibre-optic confocal microscopy (FCM) using fluorescein sodium dye for the intraoperative location of conduction tissue regions during paediatric heart surgery.
METHODS
The pilot study included 6 patients undergoing elective surgery for the closure of isolated secundum atrial septal defect aged 30 days to 21 years. FCM imaging was integrated within the normal intraoperative protocol for atrial septal defect repair. Fluorescein sodium dye was applied on the arrested heart. FCM images were acquired at the atrioventricular node region, sinus node region and right ventricle (RV). Total imaging time was limited to 3 min. Any adverse events related to the study were recorded and analysed. Subjects received standard postoperative care. Trained reviewers (n = 9) classified, de-identified and randomized FCM images (n = 60) recorded from the patients as presenting striated, reticulated or indistinguishable microstructures. The reliability of reviewer agreement was assessed using Fleiss' kappa.
RESULTS
The FCM imaging instruments were integrated effectively into the cardiac surgery operating room. All adverse events found in the study were deemed expected and not related to FCM imaging. Reticulated myocardial microstructures were found during FCM imaging at atrioventricular node and sinus node regions, while striated microstructures were observed in RV. Reliability of agreement of reviewers classifying the FCM images was high (Fleiss' kappa: 0.822).
CONCLUSIONS
FCM using fluorescein sodium dye was found to be safe for use during paediatric heart surgery. The study demonstrates the potential for FCM to be effective in identifying conduction tissue regions during congenital heart surgery.
CLINICAL TRIAL REGISTRATION NUMBER
NCT03189134.",2020,"Reliability of agreement of reviewers classifying the FCM images was high (Fleiss' kappa: 0.822).
","['6 patients undergoing elective surgery for the closure of isolated secundum atrial septal defect aged 30\u2009days to 21\u2009years', 'paediatric heart surgery']","['real-time fibre-optic confocal microscopy', 'fibre-optic confocal microscopy (FCM) using fluorescein sodium dye', 'FCM', 'FCM using fluorescein sodium dye', 'standard postoperative care', 'Fluorescein sodium dye']","['Reticulated myocardial microstructures', 'Total imaging time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0344724', 'cui_str': 'Atrial septal defect within oval fossa (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0242842', 'cui_str': 'Microscopy, Confocal'}, {'cui': 'C0147866', 'cui_str': 'fluorescein sodium'}, {'cui': 'C0013343', 'cui_str': 'Dyes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",6.0,0.039689,"Reliability of agreement of reviewers classifying the FCM images was high (Fleiss' kappa: 0.822).
","[{'ForeName': 'Aditya K', 'Initials': 'AK', 'LastName': 'Kaza', 'Affiliation': ""Department of Cardiac Surgery, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Mondal', 'Affiliation': ""Department of Cardiac Surgery, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Breanna', 'Initials': 'B', 'LastName': 'Piekarski', 'Affiliation': ""Department of Cardiac Surgery, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Sachse', 'Affiliation': 'Department of Biomedical Engineering, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hitchcock', 'Affiliation': 'Department of Biomedical Engineering, University of Utah, Salt Lake City, UT, USA.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezaa040']
826,31402745,Relational Savoring Reduces Physiological Reactivity and Enhances Psychological Agency in Older Adults.,"The benefits of savoring interventions for improving mental health have recently been demonstrated with older adults. Using a randomized controlled design involving N = 63 adults (aged 60-90 years), we explore whether relational savoring, a targeted intervention in which participants savor (intensify and prolong) positive emotions associated with the connection experienced with another person, particularly those involving the provision of safe haven/secure base attachment care, is associated with a state of lower cardiovascular reactivity (lower heart rate) during its enactment, as well as greater agency and lower passivity in a post-savoring advice-giving task. We compare all outcomes to participants randomized to a control condition utilized in prior investigations of relational savoring. Results suggest that relational savoring results in lower reactivity and greater agency and passivity. Although preliminary and obtained within a small sample, these findings provide early evidence of the potential of this approach with this population.",2020,Results suggest that relational savoring results in lower reactivity and greater agency and passivity.,"['older adults', 'N = 63 adults (aged 60-90 years', 'Older Adults']","['relational savoring, a targeted intervention in which participants savor (intensify and prolong) positive emotions associated with the connection experienced with another person, particularly those involving the provision of safe haven/secure base attachment care', 'savoring interventions', 'Relational Savoring']",['lower reactivity and greater agency and passivity'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0185023', 'cui_str': 'pexy'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",63.0,0.0767086,Results suggest that relational savoring results in lower reactivity and greater agency and passivity.,"[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Borelli', 'Affiliation': 'University of California, Irvine, USA.'}, {'ForeName': 'David Kyle', 'Initials': 'DK', 'LastName': 'Bond', 'Affiliation': 'University of California, Irvine, USA.'}, {'ForeName': 'Schuyler', 'Initials': 'S', 'LastName': 'Fox', 'Affiliation': 'Pomona College, Claremont, CA, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Horn-Mallers', 'Affiliation': 'California State University, Fullerton, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464819866972']
827,32423446,A music- and game-based oral health education for visually impaired school children; multilevel analysis of a cluster randomized controlled trial.,"BACKGROUND
Visually impaired children encounter some challenges for their oral health. We aimed to compare the effectiveness of oral health education using Audio Tactile Performance (ATP) technique alone, ATP combined with oral health education for mothers, and ATP along with art package on the oral health status of visually impaired children.
MATERIALS AND METHODS
This cluster, randomized trial, included visually impaired children from preschool to 10th grade (32 classes, n = 200), in Tehran, Iran, in 2018-2019. A questionnaire was filled out through face to face interviews at baseline regarding age, gender, status of visual impairment, and place of residence. The Simplified Oral Hygiene Index (OHI-S) and Bleeding on Probing (BOP) were examined afterward. Classes were randomly assigned to three groups through simple randomization: 1. Art group (ATP, game-based, and music-based education (11 classes, n = 66); 2. Mothers group (children received ATP and their mothers received education by telephone (10 classes, n = 73); and 3. Control group (children received ATP (11 classes, n = 61). Children received reinforcement after 1 and 2 weeks. Follow-up oral examinations were performed after 1 and 2 months by a blind calibrated examiner. Descriptive statistics were performed using Chi-Square, and ANOVA tests by SPSS (version 22). In analytic statistics, two-level mixed-effects models for BOP and OHI-S were fitted using the Statistical Analysis Software (SAS) version 9.4. Both models fitted with the grouping variable and time (baseline, 1, and 2 months after interventions) as the fixed effects.
RESULTS
The mean age (SD) of the children was 12.29 (3.45) years (range: 6-17). Male children (67%) more than female children (33%) participated in the study. Also, 35.5% were blind, and 12% resided at the dormitory. The art and mothers groups had no statistically significant difference compared with the control group, in terms of OHI-S (P = 0.92, and 0.39, respectively) and BOP (OR = 0.64, and 0.66, respectively). The time effect was statistically significant in both BOP and OHI-S models (P < 0.0001).
CONCLUSIONS
ATP technique is an effective method to improve the oral health status of visually impaired school children. Oral health promotion programs can be done using this method to tackle oral hygiene problems in visually impaired children.
TRIAL REGISTRATION
(https://www.irct.ir/trial/34676: Nov 29th, 2018).",2020,"The art and mothers groups had no statistically significant difference compared with the control group, in terms of OHI-S (P = 0.92, and 0.39, respectively) and BOP (OR = 0.64, and 0.66, respectively).","['included visually impaired children from preschool to 10th grade (32 classes, n\u2009=\u2009200), in Tehran, Iran, in 2018-2019', 'visually impaired children', 'Mothers group (children received', 'mothers, and ATP along with art package on the oral health status of visually impaired children', 'Male children (67%) more than female children (33%) participated in the study', 'The mean age (SD) of the children was 12.29 (3.45) years', 'visually impaired school children']","['ATP', 'oral health education using Audio Tactile Performance (ATP) technique alone, ATP combined with oral health education', 'music- and game-based oral health education']","['OHI-S', 'BOP', 'BOP and OHI-S models', 'oral health status', 'Simplified Oral Hygiene Index (OHI-S) and Bleeding on Probing (BOP', 'BOP and OHI-S']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0029165', 'cui_str': 'Oral Hygiene Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}]",,0.0972671,"The art and mothers groups had no statistically significant difference compared with the control group, in terms of OHI-S (P = 0.92, and 0.39, respectively) and BOP (OR = 0.64, and 0.66, respectively).","[{'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Sharififard', 'Affiliation': 'Research Center for Caries Prevention, Dentistry Research Institute, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Katayoun', 'Initials': 'K', 'LastName': 'Sargeran', 'Affiliation': 'Research Center for Caries Prevention, Dentistry Research Institute, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran. k-sargeran@tums.ac.ir.'}, {'ForeName': 'Mahdia', 'Initials': 'M', 'LastName': 'Gholami', 'Affiliation': 'Research Center for Caries Prevention, Dentistry Research Institute, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Zayeri', 'Affiliation': 'Proteomics Research Center and Department of Biostatistics, Faculty of Paramedical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",BMC oral health,['10.1186/s12903-020-01131-5']
828,31305878,Association of Screen Time and Depression in Adolescence.,"Importance
Increases in screen time have been found to be associated with increases in depressive symptoms. However, longitudinal studies are lacking.
Objective
To repeatedly measure the association between screen time and depression to test 3 explanatory hypotheses: displacement, upward social comparison, and reinforcing spirals.
Design, Setting, and Participants
This secondary analysis used data from a randomized clinical trial assessing the 4-year efficacy of a personality-targeted drug and alcohol prevention intervention. This study assessed screen time and depression throughout 4 years, using an annual survey in a sample of adolescents who entered the seventh grade in 31 schools in the Greater Montreal area. Data were collected from September 2012 to September 2018. Analysis began and ended in December 2018.
Main Outcomes and Measures
Independent variables were social media, television, video gaming, and computer use. Symptoms of depression was the outcome, measured using the Brief Symptoms Inventory. Exercise and self-esteem were assessed to test displacement and upward social comparison hypothesis.
Results
A total of 3826 adolescents (1798 girls [47%]; mean [SD] age, 12.7 [0.5] years) were included. In general, depression symptoms increased yearly (year 1 mean [SD], 4.29 [5.10] points; year 4 mean [SD], 5.45 [5.93] points). Multilevel models, which included random intercepts at the school and individual level estimated between-person and within-person associations between screen time and depression. Significant between-person associations showed that for every increased hour spent using social media, adolescents showed a 0.64-unit increase in depressive symptoms (95% CI, 0.32-0.51). Similar between-level associations were reported for computer use (0.69; 95% CI, 0.47-0.91). Significant within-person associations revealed that a further 1-hour increase in social media use in a given year was associated with a further 0.41-unit increase in depressive symptoms in that same year. A similar within-person association was found for television (0.18; 95% CI, 0.09-0.27). Significant between-person and within-person associations between screen time and exercise and self-esteem supported upward social comparison and not displacement hypothesis. Furthermore, a significant interaction between the between-person and within-person associations concerning social media and self-esteem supported reinforcing spirals hypothesis.
Conclusions and Relevance
Time-varying associations between social media, television, and depression were found, which appeared to be more explained by upward social comparison and reinforcing spirals hypotheses than by the displacement hypothesis. Both screen time modes should be taken into account when developing preventive measures and when advising parents.",2019,Significant between-person and within-person associations between screen time and exercise and self-esteem supported upward social comparison and not displacement hypothesis.,"['adolescents who entered the seventh grade in 31 schools in the Greater Montreal area', '3826 adolescents (1798 girls [47%]; mean [SD] age, 12.7 [0.5] years) were included']",['personality-targeted drug and alcohol prevention intervention'],"['Exercise and self-esteem', 'depressive symptoms', 'social media use', 'social media, television, video gaming, and computer use']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205441', 'cui_str': 'Seventh (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517546', 'cui_str': '12.7 (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0009622', 'cui_str': 'Computers'}]",3826.0,0.0313868,Significant between-person and within-person associations between screen time and exercise and self-esteem supported upward social comparison and not displacement hypothesis.,"[{'ForeName': 'Elroy', 'Initials': 'E', 'LastName': 'Boers', 'Affiliation': 'Department of Psychiatry, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Afzali', 'Affiliation': 'Department of Psychiatry, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Newton', 'Affiliation': 'University of New South Wales Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Conrod', 'Affiliation': 'Department of Psychiatry, University of Montreal, Montreal, Quebec, Canada.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.1759']
829,32421521,Efficacy of Laryngeal Tube versus Bag Mask Ventilation by Inexperienced Providers.,"INTRODUCTION
Bag mask ventilation (BMV) and extraglottic devices (EGDs) are two common methods of providing rescue ventilation. BMV can be difficult to perform effectively, especially for inexperienced providers and in patients with difficult airway characteristics. There is some evidence that the laryngeal tube (LT) can be successfully placed by inexperienced providers to provide effective ventilation. However, it is unclear whether ventilation provided by LT is superior to that of BMV, especially in the hands of inexperienced airway providers. Therefore, we aimed to compare ventilation efficacy of inexperienced airway providers with BMV versus LT by primarily measuring tidal volumes and secondarily measuring peak pressures on a simulated model.
METHODS
We performed a crossover study first year emergency medicine residents and third and fourth year medical students. After a brief instructional video followed by hands on practice, participants performed both techniques in random order on a simulated model for two minutes each. Returned tidal volumes and peak pressures were measured.
RESULTS
Twenty participants were enrolled and 1200 breaths were measured, 600 per technique. The median ventilation volumes were 194 milliliters (mL) for BMV, and 387 mL for the laryngeal tube, with a median absolute difference of 170 mL (95% confidence interval [CI] 157-182 mL) (mean difference 148 mL [95% CI, 138-158 mL], p<0.001). The median ventilation peak pressures were 23 centimeters of water (cm H 2 O) for BMV, and 30 cm H 2 O for the laryngeal tube, with a median absolute difference of 7 cm H 2 O (95% CI, 6-8 cm H2O) (mean difference 8 cm H 2 O [95% CI, 7-9 cm H 2 O], p<0.001).
CONCLUSION
Inexperienced airway providers were able to provide higher ventilation volumes and peak pressures with the LT when compared to BMV in a manikin model. Inexperienced providers should consider using an LT when providing rescue ventilations in obtunded or hypoventilating patients without intact airway reflexes. Further study is required to understand whether these findings are generalizable to live patients.",2020,Inexperienced airway providers were able to provide higher ventilation volumes and peak pressures with the LT when compared to BMV in a manikin model.,"['year emergency medicine residents and third and fourth year medical students', 'Twenty participants were enrolled and 1200 breaths were measured, 600 per technique']","['BMV', 'Laryngeal Tube versus Bag Mask Ventilation', 'Bag mask ventilation (BMV) and extraglottic devices (EGDs', 'BMV versus LT']","['median ventilation volumes', 'median ventilation peak pressures', 'Returned tidal volumes and peak pressures', 'ventilation efficacy']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",20.0,0.113979,Inexperienced airway providers were able to provide higher ventilation volumes and peak pressures with the LT when compared to BMV in a manikin model.,"[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hart', 'Affiliation': 'Hennepin Healthcare, Department of Emergency Medicine, Minneapolis, Minnesota.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Driver', 'Affiliation': 'Hennepin Healthcare, Department of Emergency Medicine, Minneapolis, Minnesota.'}, {'ForeName': 'Gautham', 'Initials': 'G', 'LastName': 'Kartha', 'Affiliation': 'Hennepin Healthcare, Department of Emergency Medicine, Minneapolis, Minnesota.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Reardon', 'Affiliation': 'Hennepin Healthcare, Department of Emergency Medicine, Minneapolis, Minnesota.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Miner', 'Affiliation': 'Hennepin Healthcare, Department of Emergency Medicine, Minneapolis, Minnesota.'}]",The western journal of emergency medicine,['10.5811/westjem.2020.3.45844']
830,32423348,Associations Between Dietary Patterns and Subclinical Cardiac Injury: An Observational Analysis From the DASH Trial.,"BACKGROUND
The DASH diet has been found to lower blood pressure (BP) and low-density lipoprotein cholesterol levels.
OBJECTIVE
To compare diets rich in fruits and vegetables with a typical American diet in their effects on cardiovascular injury in middle-aged adults without known preexisting cardiovascular disease (CVD).
DESIGN
Observational study based on a 3-group, parallel-design, randomized trial conducted in the United States from 1994 to 1996. (ClinicalTrials.gov: NCT00000544).
SETTING
3 of the 4 original clinical trial centers.
PARTICIPANTS
326 of the original 459 trial participants with available stored specimens.
INTERVENTION
Participants were randomly assigned to 8 weeks of monitored feeding with a control diet typical of what many Americans eat; a diet rich in fruits and vegetables but otherwise similar to the control diet; or the DASH diet, which is rich in fruits, vegetables, low-fat dairy, and fiber and has low levels of saturated fat and cholesterol. Weight was kept constant throughout feeding.
MEASUREMENTS
Biomarkers collected at baseline and 8 weeks: high-sensitivity cardiac troponin I (hs-cTnI), N -terminal pro-B-type natriuretic peptide (NT-proBNP), and high-sensitivity C-reactive protein (hs-CRP).
RESULTS
The mean age of participants was 45.2 years, 48% were women, 49% were black, and mean baseline BP was 131/85 mm Hg. Compared with the control diet, the fruit-and-vegetable diet reduced hs-cTnI levels by 0.5 ng/L (95% CI, -0.9 to -0.2 ng/L) and NT-proBNP levels by 0.3 pg/mL (CI, -0.5 to -0.1 pg/mL). Compared with the control diet, the DASH diet reduced hs-cTnI levels by 0.5 ng/L (CI, -0.9 to -0.1 ng/L) and NT-proBNP levels by 0.3 pg/mL (CI, -0.5 to -0.04 pg/mL). Levels of hs-CRP did not differ among diets. None of the markers differed between the fruit-and-vegetable and DASH diets.
LIMITATION
Short duration, missing specimens, and an inability to isolate the effects of specific foods or micronutrients.
CONCLUSION
Diets rich in fruits and vegetables given over 8 weeks were associated with lower levels of markers for subclinical cardiac damage and strain in adults without preexisting CVD.
PRIMARY FUNDING SOURCE
National Institutes of Health, National Heart, Lung, and Blood Institute.",2020,"Diets rich in fruits and vegetables given over 8 weeks were associated with lower levels of markers for subclinical cardiac damage and strain in adults without preexisting CVD.
","['middle-aged adults without known preexisting cardiovascular disease (CVD', '3 of the 4 original clinical trial centers', '326 of the original 459 trial participants with available stored specimens', 'United States from 1994 to 1996', 'The mean age of participants was 45.2 years, 48% were women, 49% were black, and mean baseline BP was 131/85 mm Hg', 'adults without preexisting CVD']","['diets rich in fruits and vegetables with a typical American diet', 'control diet typical of what many Americans eat; a diet rich in fruits and vegetables but otherwise similar to the control diet; or the DASH diet']","['blood pressure (BP) and low-density lipoprotein cholesterol levels', 'cardiovascular injury', 'NT-proBNP levels', 'hs-cTnI levels', 'Weight', 'Levels of hs-CRP', 'high-sensitivity cardiac troponin']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0560570', 'cui_str': 'Cardiovascular injury'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}]",,0.0964925,"Diets rich in fruits and vegetables given over 8 weeks were associated with lower levels of markers for subclinical cardiac damage and strain in adults without preexisting CVD.
","[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (S.P.J., K.J.M.).'}, {'ForeName': 'Lara C', 'Initials': 'LC', 'LastName': 'Kovell', 'Affiliation': 'University of Massachusetts Medical School, Worcester, Massachusetts (L.C.K.).'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland (L.J.A., E.R.M.).'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland (L.J.A., E.R.M.).'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': ""Harvard T.H. Chan School of Public Health, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts (F.M.S.).""}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Christenson', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland (R.H.C., H.R.).'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Rebuck', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland (R.H.C., H.R.).'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Chang', 'Affiliation': 'Geisinger Health System, Danville, Pennsylvania (A.R.C.).'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (S.P.J., K.J.M.).'}]",Annals of internal medicine,['10.7326/M20-0336']
831,32423576,"Effect of tranexamic acid on blood loss after reverse total shoulder arthroplasty according to the administration method: a prospective, multicenter, randomized, controlled study.","BACKGROUND
The ideal method of administering tranexamic acid (TXA) for reverse total shoulder arthroplasty (RTSA) remains unknown. We aimed to evaluate TXA efficacy according to 3 administration methods after RTSA.
METHODS
Overall, 102 patients who underwent RTSA using a single implant between September 2016 and November 2018 were randomized to the following groups according to the TXA administration method: intravenous (n = 34; 1 g + 0.9% normal saline 100 mL), topical (n = 33; 2 g + 0.9% normal saline 50 mL), and combined groups (n = 34). Patients were enrolled in 4 tertial referral hospitals for prospective multicenter studies. The primary outcome was a hemoglobin decrease in 24 hours postoperatively; secondary outcomes were total drain volume, transfusion rate, and calculated total blood loss.
RESULTS
Demographic data, including preoperative hemoglobin levels, were not different among the 3 groups, but the average age was higher in the combined group (P = .038). Hemoglobin decrease (1.8 ± 1.1 vs. 1.8 ± 1.0 vs. 2.0 ± 1.1 g/dL, P = .769), total drain volume (209.2 ± 147.6 vs. 167.2 ± 102.0 vs. 166.0 ± 118.7, P = .270), and total blood loss (701.1 ± 352.3 vs. 656.5 ± 285.6 vs. 699.0 ± 248.7 mL, P = .810) were not significantly different among the 3 groups (all P > .05). The transfusion rate was higher in the intravenous group (n = 4), whereas only 1 patient had transfusion in the topical group and none in the combined group, although the difference was not statistically significant (P = .084).
CONCLUSION
Blood loss did not differ among TXA administration methods after RTSA. However, considering the risk of complication in intravenous TXA, topical TXA after RTSA may be safer, even for patients with normal risk for venous thromboembolic complication.",2020,"RESULTS
Demographic data, including preoperative hemoglobin levels, were not different among the 3 groups, but the average age was higher in the combined group (P = .038).","['patients with normal risk for venous thromboembolic complication', '102 patients who underwent RTSA using a single implant between September 2016 and November 2018', 'Patients were enrolled in 4 tertial referral hospitals for prospective multicenter studies']","['TXA administration method: intravenous (n = 34; 1 g + 0.9% normal saline 100 mL), topical (n = 33; 2 g + 0.9% normal saline', 'tranexamic acid (TXA', 'tranexamic acid']","['total blood loss', 'TXA efficacy', 'preoperative hemoglobin levels', 'transfusion rate', 'hemoglobin decrease', 'total drain volume', 'Hemoglobin decrease', 'total drain volume, transfusion rate, and calculated total blood loss', 'transfusion', 'blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4728044', 'cui_str': 'Reverse prosthetic total arthroplasty of shoulder'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439166', 'cui_str': '% normal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.139374,"RESULTS
Demographic data, including preoperative hemoglobin levels, were not different among the 3 groups, but the average age was higher in the combined group (P = .038).","[{'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Yoon', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Bundang Jesaeng General Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Yang Soo', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': ""Catholic University College of Medicine, Seoul St. Mary's Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Sang Jin', 'Initials': 'SJ', 'LastName': 'Shin', 'Affiliation': 'Ewha Womans University College of Medicine, Ewha Womans University Seoul Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Chul', 'Initials': 'JC', 'LastName': 'Yoo', 'Affiliation': 'Sungkyunkwan University College of Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Joo Han', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea. Electronic address: ohjh1@snu.ac.kr.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.02.013']
832,31693129,Phase III Randomized Trial of Bisphosphonates as Adjuvant Therapy in Breast Cancer: S0307.,"BACKGROUND
Adjuvant bisphosphonates, when given in a low-estrogen environment, can decrease breast cancer recurrence and death. Treatment guidelines include recommendations for adjuvant bisphosphonates in postmenopausal patients. SWOG/Alliance/Canadian Cancer Trials Group/ECOG-ACRIN/NRG Oncology study S0307 compared the efficacy of three bisphosphonates in early-stage breast cancer.
METHODS
Patients with stage I-III breast cancer were randomly assigned to 3 years of intravenous zoledronic acid, oral clodronate, or oral ibandronate. The primary endpoint was disease-free survival (DFS) with overall survival as a secondary outcome. All statistical tests were two-sided.
RESULTS
A total of 6097 patients enrolled. Median age was 52.7 years. Prior to being randomly assigned, 73.2% patients indicated preference for oral vs intravenous formulation. DFS did not differ across arms in a log-rank test (P = .49); 5-year DFS was 88.3% (zoledronic acid: 95% confidence interval [CI] = 86.9% to 89.6%), 87.6% (clodronate: 95% CI = 86.1% to 88.9%), and 87.4% (ibandronate: 95% CI = 85.6% to 88.9%). Additionally, 5-year overall survival did not differ between arms (log rank P = .50) and was 92.6% (zoledronic acid: 95% CI = 91.4% to 93.6%), 92.4% (clodronate: 95% CI = 91.2% to 93.5%), and 92.9% (ibandronate: 95% CI = 91.5% to 94.1%). Bone as first site of recurrence did not differ between arms (P = .93). Analyses based on age and tumor subtypes showed no treatment differences. Grade 3/4 toxicity was 8.8% (zoledronic acid), 8.3% (clodronate), and 10.5% (ibandronate). Osteonecrosis of the jaw was highest for zoledronic acid (1.26%) compared with clodronate (0.36%) and ibandronate (0.77%).
CONCLUSIONS
We found no evidence of differences in efficacy by type of bisphosphonate, either in overall analysis or subgroups. Despite an increased rate of osteonecrosis of the jaw with zoledronic acid, overall toxicity grade differed little across arms. Given that patients expressed preference for oral formulation, efforts to make oral agents available in the United States should be considered.",2020,"Osteonecrosis of the Jaw (ONJ) was highest for zoledronic acid (1.26%), compared to clodronate (0.36%) and ibandronate (0.77%).
","['Patients with stage I-III breast cancer', '6,097 patients enrolled', 'breast cancer', 'Median age was 52.7 years', 'early stage breast cancer', 'postmenopausal patients']","['clodronate', 'bisphosphonate', 'zoledronic acid', 'intravenous zoledronic acid, oral clodronate, or oral ibandronate', 'bisphosphonates']","['Osteonecrosis of the Jaw (ONJ', 'breast cancer recurrence and death', 'Grade 3/4 toxicity', 'disease-free survival (DFS) with overall survival (OS', 'DFS', '5-year', 'rate of ONJ with zoledronic acid, overall toxicity grade']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}]","[{'cui': 'C0162357', 'cui_str': 'Clodronate'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0379199', 'cui_str': 'Ibandronate'}]","[{'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}]",,0.212636,"Osteonecrosis of the Jaw (ONJ) was highest for zoledronic acid (1.26%), compared to clodronate (0.36%) and ibandronate (0.77%).
","[{'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Barlow', 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'Alexander H G', 'Initials': 'AHG', 'LastName': 'Paterson', 'Affiliation': 'Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Jieling L', 'Initials': 'JL', 'LastName': ""M'iao"", 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'Danika L', 'Initials': 'DL', 'LastName': 'Lew', 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'Alison T', 'Initials': 'AT', 'LastName': 'Stopeck', 'Affiliation': 'Stony Brook Cancer Center, Stony Brook University Cancer Center, Stony Brook, NY.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'University of Michigan, Ann Arbor, MI (DFH, CHVP); Columbia University, New York, NY.'}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': ''}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Schubert', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Van Poznak', 'Affiliation': ''}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Dees', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Ingle', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Carla I', 'Initials': 'CI', 'LastName': 'Falkson', 'Affiliation': 'University of Alabama, Birmingham, AL.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Elias', 'Affiliation': 'University of Colorado, Denver, CO.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Messino', 'Affiliation': 'Cancer Care of WNC, Greenville, NC.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Margolis', 'Affiliation': 'Beaumont NCORP/William Beaumont Hospital, Royal Oak, MI.'}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Wichita NCORP, Wichita, KS.'}, {'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Chew', 'Affiliation': 'University of California at Davis, Sacramento, CA.'}, {'ForeName': 'Kim Z', 'Initials': 'KZ', 'LastName': 'Dammann', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Abrams', 'Affiliation': 'Cancer Therapy and Evaluation Program, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Livingston', 'Affiliation': 'University of Arizona, Tucson, AZ.'}, {'ForeName': 'Gabriel N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djz215']
833,32073608,Twice as High Diet-Induced Thermogenesis After Breakfast vs Dinner On High-Calorie as Well as Low-Calorie Meals.,"BACKGROUND
The question of whether there is daytime time variation in diet-induced thermogenesis (DIT) has not been clearly answered. Moreover, it is unclear whether a potential diurnal variation in DIT is preserved during hypocaloric nutrition.
OBJECTIVE
We hypothesized that DIT varies depending on the time of day and explored whether this physiological regulation is preserved after low-calorie compared with high-calorie intake.
DESIGN
Under blinded conditions, 16 normal-weight men twice underwent a 3-day in-laboratory, randomized, crossover study. Volunteers consumed a predetermined low-calorie breakfast (11% of individual daily kilocalorie requirement) and high-calorie dinner (69%) in one condition and vice versa in the other. DIT was measured by indirect calorimetry, parameters of glucose metabolism were determined, and hunger and appetite for sweets were rated on a scale.
RESULTS
Identical calorie consumption led to a 2.5-times higher DIT increase in the morning than in the evening after high-calorie and low-calorie meals (P < .001). The food-induced increase of blood glucose and insulin concentrations was diminished after breakfast compared with dinner (P < .001). Low-calorie breakfast increased feelings of hunger (P < .001), specifically appetite for sweets (P = .007), in the course of the day.
CONCLUSIONS
DIT is clearly higher in the morning than in the evening, irrespective of the consumed calorie amount; that is, this physiological rhythmicity is preserved during hypocaloric nutrition. Extensive breakfasting should therefore be preferred over large dinner meals to prevent obesity and high blood glucose peaks even under conditions of a hypocaloric diet.",2020,"Low-calorie breakfast increased feelings of hunger (P < .001), specifically appetite for sweets (P = .007), in the course of the day.
",['16 normal-weight men twice underwent a 3-day in-laboratory'],"['Low-calorie breakfast', 'High Diet-Induced Thermogenesis', 'Breakfast vs Dinner']","['blood glucose and insulin concentrations', 'appetite for sweets', 'hunger and appetite for sweets', 'feelings of hunger']","[{'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",,0.0978093,"Low-calorie breakfast increased feelings of hunger (P < .001), specifically appetite for sweets (P = .007), in the course of the day.
","[{'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Richter', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Lubeck, Lubeck, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Herzog', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Lubeck, Lubeck, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Janka', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Lubeck, Lubeck, Germany.'}, {'ForeName': 'Thalke', 'Initials': 'T', 'LastName': 'Baumann', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Lubeck, Lubeck, Germany.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Kistenmacher', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Lubeck, Lubeck, Germany.'}, {'ForeName': 'Kerstin M', 'Initials': 'KM', 'LastName': 'Oltmanns', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Lubeck, Lubeck, Germany.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz311']
834,31536112,"Exercise for Smoking Cessation in Postmenopausal Women: A Randomized, Controlled Trial.","BACKGROUND
Postmenopausal smokers have difficulty quitting smoking and experience considerable weight gain with smoking cessation. We examined whether adjunctive smoking treatment with exercise, compared to a relaxation control condition, could improve cigarette abstinence, decrease cigarettes smoked per day (CPD), and ameliorate changes in body mass index (BMI) in postmenopausal smokers.
METHODS
Women (N = 301) signed informed consent and were randomized to treatment at two sites (Universities of Connecticut and Minnesota). We randomized groups of participants to a comprehensive group treatment program that included 12 weeks of varenicline and either a moderate exercise or relaxation component for 6 months. Participants were followed for a year after medication treatment.
RESULTS
Overall, 17.3% of patients reported carbon monoxide-verified continuous abstinence for the 9- to 12-week period, and 11.6% reported prolonged abstinence at 1 year, with no significant differences between treatment conditions. CPD reported at study visits showed significant main effects for time in weeks, for site, and for treatment. The Exercise condition reported smoking fewer CPD over time, and that advantage widened over time. In terms of BMI, significant effects for time in weeks, and for the interaction of Week × Treatment condition, reflected gradually increasing BMI in these women over time, but with the increase in BMI slower in the Exercise condition.
CONCLUSIONS
Exercise, compared to relaxation, was associated with a reduced BMI and CPD in postmenopausal women, but did not increase end of treatment or prolonged abstinence. Further research is needed to devise exercise programs that increase smoking cessation rates in postmenopausal women.
IMPLICATIONS
This study adds to the literature on the effectiveness of a moderate exercise intervention compared to a relaxation control condition as an adjunctive treatment for smoking cessation in postmenopausal women. Our exercise program did not increase end of treatment or prolonged abstinence rates in postmenopausal women; however, there was a beneficial effect on smoking reduction and reduced body mass index. Additional research is needed to devise exercise programs that increase smoking cessation rates in postmenopausal women.",2020,"CPD reported at study visits showed significant main effects for time in weeks, for site, and for treatment.","['Postmenopausal smokers', 'Women ', 'postmenopausal smokers', 'postmenopausal women', 'Post-Menopausal Women']","['moderate exercise intervention', 'relaxation control condition', 'Exercise', 'varenicline and either a moderate exercise or relaxation component']","['carbon monoxide-verified continuous abstinence', 'prolonged abstinence', 'BMI', 'smoking cessation rates', 'prolonged abstinence rates', 'BMI and CPD', 'BMI slower', 'cigarette abstinence, decrease cigarettes smoked per day (CPD) and ameliorate changes in body mass index (BMI']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke (substance)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0292739,"CPD reported at study visits showed significant main effects for time in weeks, for site, and for treatment.","[{'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Oncken', 'Affiliation': 'Department of Medicine, UConn School of Medicine, Farmington, CT.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Litt', 'Affiliation': 'Department of Behavioral Sciences, UConn School of Dental Medicine, Farmington, CT.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kenny', 'Affiliation': 'Department of Medicine, UConn School of Medicine, Farmington, CT.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Lando', 'Affiliation': 'Department of Epidemiology, University of Minnesota, Minneapolis, MN (Lando).'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine, University of Arizona, Tuscon, AZ.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Dornelas', 'Affiliation': 'Department of Medicine, UConn School of Medicine, Farmington, CT.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz176']
835,32493211,"Dural sac cross-sectional area is a highly effective parameter for spinal anesthesia in geriatric patients undergoing transurethral resection of the prostate: a prospective, double blinded, randomized study.","BACKGROUND
Spinal anesthesia is optimal choice for transurethral resection of the prostate (TURP), but the sensory block should not cross the T10 level. With advancing age, the sensory blockade level increases after spinal injection in some patients with spinal canal stenosis. We optimize the dose of spinal anesthesia according to the decreased ratio of the dural sac cross-sectional area (DSCSA), the purpose of this study is to hypothesis that if DSCSA is an effective parameter to modify the dosage of spinal anesthetics to achieve a T10 blockade in geriatric patients undergoing TURP.
METHODS
Sixty geriatric patients schedule for TURP surgery were enrolled in this study. All subjects were randomized divided into two groups, the ultrasound (group U) and the control (group C) groups, patient receive either a dose of 2 ml of 0.5% isobaric bupivacaine in group C, or a modified dose of 0.5% isobaric bupivacaine in group U. We measured the sagittal anteroposterior diameter (D) of the dural sac at the L3-4 level with ultrasound, and calculated the approximate DSCSA (A) according to the following formula: A = π(D/2) 2 , ( π = 3.14). The modified dosage of bupivacaine was adjusted according to the decreased ratio of the DSCSA.
RESULTS
The cephalad spread of the sensory blockade level was significantly lower (P < 0.001) in group U (T10, range T7-T12) compared with group C (T3, range T2-T9). The dosage of bupivacaine was significantly decreased in group U compared with group C (P < 0.001). The regression times of the two segments were delay in group U compared with group C (P < 0.001). The maximal decrease in MAP was significantly higher in the group C than in group U after spinal injection (P < 0.001), without any modifications HR in either group. Eight patients in group C and two patients in group U required ephedrine (P = 0.038).
CONCLUSIONS
The DSCSA is a highly effective parameter for spinal anesthesia in geriatric patients undergoing TURP, a modified dose of local anesthetic is a critical factor for controlling the sensory level.
TRIAL REGISTRATION
This study was registered in the Chinese Clinical Trial Registry (Registration number: ChiCTR1800015566).on 8, April, 2018.",2020,"The cephalad spread of the sensory blockade level was significantly lower (P < 0.001) in group U (T10, range T7-T12) compared with group C (T3, range T2-T9).","['Sixty geriatric patients schedule for TURP surgery were enrolled in this study', 'geriatric patients undergoing transurethral resection of the prostate', 'geriatric patients undergoing TURP', 'geriatric patients undergoing', 'patients with spinal canal stenosis']","['TURP', 'bupivacaine', 'DSCSA', 'modified dose of 0.5% isobaric bupivacaine', 'patient receive either a dose of 2\u2009ml of 0.5% isobaric bupivacaine', 'spinal anesthesia', 'ephedrine']","['sagittal anteroposterior diameter (D) of the dural sac', 'cephalad spread of the sensory blockade level', 'maximal decrease in MAP']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1861329', 'cui_str': 'Spinal canal stenosis'}]","[{'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}]","[{'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",60.0,0.0363662,"The cephalad spread of the sensory blockade level was significantly lower (P < 0.001) in group U (T10, range T7-T12) compared with group C (T3, range T2-T9).","[{'ForeName': 'Wei Bing', 'Initials': 'WB', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Affiliated AnQing Hospitals of Anhui Medical University, 352th, Renming Road, AnQing, 246003, AnHui province, China. w2bwang@sina.com.'}, {'ForeName': 'Ai Jiao', 'Initials': 'AJ', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, The Affiliated AnQing Hospitals of Anhui Medical University, 352th, Renming Road, AnQing, 246003, AnHui province, China.'}, {'ForeName': 'Hong Ping', 'Initials': 'HP', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, The Affiliated AnQing Hospitals of Anhui Medical University, 352th, Renming Road, AnQing, 246003, AnHui province, China.'}, {'ForeName': 'Jing Chun', 'Initials': 'JC', 'LastName': 'Dong', 'Affiliation': 'Department of Anesthesiology, The Affiliated AnQing Hospitals of Anhui Medical University, 352th, Renming Road, AnQing, 246003, AnHui province, China.'}, {'ForeName': 'Huang', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, The Affiliated AnQing Hospitals of Anhui Medical University, 352th, Renming Road, AnQing, 246003, AnHui province, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01059-x']
836,30055710,"Impact of the Out-of-School Nutrition and Physical Activity (OSNAP) Group Randomized Controlled Trial on Children's Food, Beverage, and Calorie Consumption among Snacks Served.","BACKGROUND
Afterschool interventions have been found to improve the nutritional quality of snacks served. However, there is limited evidence on how these interventions affect children's snacking behaviors.
OBJECTIVE
Our aim was to determine the impact of an afterschool intervention focused at the school district, site, family, and child levels on dietary consumption of foods and beverages served at snack.
DESIGN
This was a secondary analysis of a group-randomized controlled trial.
PARTICIPANTS/SETTING
Data were collected from 400 children at 20 afterschool sites in Boston, MA before (fall 2010) and after (spring 2011) intervention implementation.
INTERVENTION
The Out-of-School Nutrition and Physical Activity intervention aimed to promote fruits, vegetables, whole grains, and water, while limiting sugary drinks and trans fats. Researchers worked with district foodservice staff to change snack foods and beverages. Teams of afterschool staff participated in three 3-hour learning collaborative sessions to build skills and created action plans for changing site practices. The intervention included family and child nutrition education.
MAIN OUTCOME MEASURES
Research assistants observed dietary snack consumption using a validated measure on 2 days per site at baseline and follow-up.
STATISTICAL ANALYSES PERFORMED
This study used multivariable regression models, accounting for clustering of observations, to assess the intervention effect, and conducted post-hoc stratified analyses by foodservice type.
RESULTS
Children in intervention sites had greater decreases in consumption of juice (-0.61 oz/snack, 95% CI -1.11 to -0.12), beverage calories (-29.1 kcal/snack, 95% CI -40.2 to 18.0), foods with trans fats (-0.12 servings/snack, 95% CI -0.19 to -0.04), total calories (-47.7 kcal/snack, 95% CI -68.2 to -27.2), and increases in consumption of whole grains (0.10 servings/snack, 95% CI 0.02 to 0.18) compared to controls. In post-hoc analyses, sites with on-site foodservice had significant improvements for all outcomes (P<0.001), with no effect for sites with satellite foodservice.
CONCLUSIONS
Results demonstrate that an afterschool intervention can improve children's dietary snack consumption, particularly at sites with on-site foodservice.",2018,"RESULTS
Children in intervention sites had greater decreases in consumption of juice (-0.61 oz/snack, 95% CI -1.11 to -0.12), beverage calories (-29.1 kcal/snack, 95% CI -40.2 to 18.0), foods with trans fats (-0.12 servings/snack, 95%","['Data were collected from 400 children at 20 afterschool sites in Boston, MA before (fall 2010) and after (spring 2011) intervention implementation']","['Out-of-School Nutrition and Physical Activity (OSNAP', 'Physical Activity intervention aimed to promote fruits, vegetables, whole grains, and water, while limiting sugary drinks and trans fats', 'afterschool intervention']","['dietary snack consumption', 'total calories', 'consumption of whole grains', 'beverage calories', 'consumption of juice', ""children's dietary snack consumption""]","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}]","[{'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C1268568', 'cui_str': 'Juice'}]",400.0,0.102318,"RESULTS
Children in intervention sites had greater decreases in consumption of juice (-0.61 oz/snack, 95% CI -1.11 to -0.12), beverage calories (-29.1 kcal/snack, 95% CI -40.2 to 18.0), foods with trans fats (-0.12 servings/snack, 95%","[{'ForeName': 'Rebekka M', 'Initials': 'RM', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Giles', 'Affiliation': ''}, {'ForeName': 'Angie L', 'Initials': 'AL', 'LastName': 'Cradock', 'Affiliation': ''}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Emmons', 'Affiliation': ''}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Okechukwu', 'Affiliation': ''}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Kenney', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Thayer', 'Affiliation': ''}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Gortmaker', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2018.04.011']
837,31521161,Effect of play-based family-centered psychomotor/psychosocial stimulation on the development of severely acutely malnourished children under six in a low-income setting: a randomized controlled trial.,"BACKGROUND
The World Health Organization (WHO) recommends incorporating psychosocial stimulation into the management of severe acute malnutrition (SAM). However, there is little evidence about the effectiveness of these interventions for SAM children, particularly when serious food shortages and lack of a balanced diet prevail. The objective of this study was to examine whether family-based psychomotor/psychosocial stimulation in a low-income setting improves the development, linear growth, and nutritional outcomes in children with SAM.
METHOD
Children with SAM (N = 339) admitted for treatment to the Jimma University Specialized Hospital, Ethiopia, were randomized to a control (n = 170) or intervention (n = 169) group. Both groups received routine medical care and nutritional treatment at the hospital. The intervention group additionally received play-based psychomotor/psychosocial stimulation during their hospital stay, and at home for 6 months after being discharged from hospital. The fine motor (FM) and gross motor (GM) functions, language (LA) and personal-social (PS) skills of the children were assessed using adapted Denver II, the social-emotional (SE) behavior was assessed using adapted Ages and Stages Questionnaires: Social-Emotional, and the linear growth and nutritional status were determined through anthropometric assessments. All outcomes were assessed before the intervention, upon discharge from hospital, and 6 months after discharge (as end-line). The overtime changes of these outcomes measured in both groups were compared using Generalized Estimating Equations.
RESULTS
The intervention group improved significantly on GM during hospital follow-up by 0.88 points (p < 0.001, effect size = 0.26 SD), and on FM functions during the home follow-up by 1.09 points (p = 0.001, effect size = 0.22 SD). Both young and older children benefited similarly from the treatment. The intervention did not contribute significantly to linear growth and nutritional outcomes.
CONCLUSION
Psychomotor/psychosocial stimulation of SAM children enhances improvement in gross motor functions when combined with standard nutrient-rich diets, but it can enhance the fine motor functions even when such standard dietary care is not available.
TRIAL REGISTRATION
The trial was retrospectively registered on 30 January 2017 at the US National Institute of Health (ClinicalTrials.gov) # NCT03036176 .",2019,"The intervention group improved significantly on GM during hospital follow-up by 0.88 points (p < 0.001, effect size = 0.26 SD), and on FM functions during the home follow-up by 1.09 points (p = 0.001, effect size = 0.22 SD).","['children with SAM', '30 January 2017 at the US National Institute of Health (ClinicalTrials.gov) # NCT03036176 ', 'severe acute malnutrition (SAM', 'severely acutely malnourished children under six in a low-income setting', 'Children with SAM (N\u2009=\u2009339) admitted for treatment to the Jimma University Specialized Hospital, Ethiopia']","['routine medical care and nutritional treatment', 'play-based family-centered psychomotor/psychosocial stimulation', 'family-based psychomotor/psychosocial stimulation', 'play-based psychomotor/psychosocial stimulation']","['fine motor (FM) and gross motor (GM) functions, language (LA) and personal-social (PS) skills of the children were assessed using adapted Denver II, the social-emotional (SE) behavior', 'linear growth and nutritional outcomes', 'GM during hospital follow', 'FM functions', 'Social-Emotional, and the linear growth and nutritional status']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}]",,0.0356973,"The intervention group improved significantly on GM during hospital follow-up by 0.88 points (p < 0.001, effect size = 0.26 SD), and on FM functions during the home follow-up by 1.09 points (p = 0.001, effect size = 0.22 SD).","[{'ForeName': 'Teklu Gemechu', 'Initials': 'TG', 'LastName': 'Abessa', 'Affiliation': 'Department of Special Needs and Inclusive Education, College of Behavioral Sciences and Education, Jimma University, Jimma, Ethiopia. teklugem@yahoo.com.'}, {'ForeName': 'Berhanu Nigussie', 'Initials': 'BN', 'LastName': 'Worku', 'Affiliation': 'REVAL Rehabilitation Research Center, Biomedical Research Institute, Faculty of Rehabilitation Sciences and Physiotherapy, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Mekitie', 'Initials': 'M', 'LastName': 'Wondafrash', 'Affiliation': 'Department of Population and Family Health, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Tsinuel', 'Initials': 'T', 'LastName': 'Girma', 'Affiliation': 'Department of Pediatrics and Child Health, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Valy', 'Affiliation': 'Department of Healthcare, PXL University College, Hasselt, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lemmens', 'Affiliation': 'Department of Healthcare, PXL University College, Hasselt, Belgium.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Bruckers', 'Affiliation': 'I-Biostat, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kolsteren', 'Affiliation': 'Department of Food Safety and Food Quality, University of Gent, Ghent, Belgium.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Granitzer', 'Affiliation': 'REVAL Rehabilitation Research Center, Biomedical Research Institute, Faculty of Rehabilitation Sciences and Physiotherapy, Hasselt University, Hasselt, Belgium.'}]",BMC pediatrics,['10.1186/s12887-019-1696-z']
838,21284444,Observer variability in the interpretation of HER2/neu immunohistochemical expression with unaided and computer-aided digital microscopy.,"CONTEXT
Observer variability in digital microscopy and the effect of computer-aided digital microscopy are underexamined areas in need of further research, considering the increasing use and future role of digital imaging in pathology. A reduction in observer variability using computer aids could enhance the statistical power of studies designed to determine the utility of new biomarkers and accelerate their incorporation in clinical practice.
OBJECTIVES
To quantify interobserver and intraobserver variability in immunohistochemical analysis of HER2/neu with digital microscopy and computer-aided digital microscopy, and to test the hypothesis that observer agreement in the quantitative assessment of HER2/neu immunohistochemical expression is increased with the use of computer-aided microscopy.
DESIGN
A set of 335 digital microscopy images extracted from 64 breast cancer tissue slides stained with a HER2 antibody, were read by 14 observers in 2 reading modes: the unaided mode and the computer-aided mode. In the unaided mode, HER2 images were displayed on a calibrated color monitor with no other information, whereas in the computer-aided mode, observers were shown a HER2 image along with a corresponding feature plot showing computer-extracted values of membrane staining intensity and membrane completeness for the particular image under examination and, at the same time, mean feature values of the different HER2 categories. In both modes, observers were asked to provide a continuous score of HER2 expression.
RESULTS
Agreement analysis performed on the output of the study showed significant improvement in both interobserver and intraobserver agreement when the computer-aided reading mode was used to evaluate preselected image fields.
CONCLUSION
The role of computer-aided digital microscopy in reducing observer variability in immunohistochemistry is promising.",2011,"RESULTS
Agreement analysis performed on the output of the study showed significant improvement in both interobserver and intraobserver agreement when the computer-aided reading mode was used to evaluate preselected image fields.
",['64 breast cancer tissue slides stained with a HER2 antibody'],['HER2/neu with digital microscopy and computer-aided digital microscopy'],['HER2/neu immunohistochemical expression'],"[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}]",335.0,0.0147704,"RESULTS
Agreement analysis performed on the output of the study showed significant improvement in both interobserver and intraobserver agreement when the computer-aided reading mode was used to evaluate preselected image fields.
","[{'ForeName': 'Marios A', 'Initials': 'MA', 'LastName': 'Gavrielides', 'Affiliation': 'Division of Imaging and Applied Mathematics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland 20993, USA. marios.gavrielides@fda.hhs.gov'}, {'ForeName': 'Brandon D', 'Initials': 'BD', 'LastName': 'Gallas', 'Affiliation': ''}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Lenz', 'Affiliation': ''}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Badano', 'Affiliation': ''}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Hewitt', 'Affiliation': ''}]",Archives of pathology & laboratory medicine,['10.1043/1543-2165-135.2.233']
839,31536116,Parents' Self-efficacy for Tobacco Exposure Protection and Smoking Abstinence Mediate Treatment Effects on Child Cotinine at 12-Month Follow-up: Mediation Results from the Kids Safe and Smokefree Trial.,"INTRODUCTION
Compared with the general smoking population, low-income smokers face elevated challenges to success in evidence-based smoking cessation treatment. Moreover, their children bear increased disease burden. Understanding behavioral mechanisms related to successful reduction of child tobacco smoke exposure (TSE) could inform future smoking interventions in vulnerable, underserved populations.
METHODS
Smoking parents were recruited from pediatric clinics in low-income communities and randomized into a multilevel intervention including a pediatric clinic intervention framed in best clinical practice guidelines (""Ask, Advise, Refer"" [AAR]) plus individualized telephone counseling (AAR + counseling), or AAR + control. Mediation analysis included treatment condition (independent variable), 12-month child cotinine (TSE biomarker, criterion), and four mediators: 3-month end-of-treatment self-efficacy to protect children from TSE and smoking urge coping skills, and 12-month perceived program (intra-treatment) support and bioverified smoking abstinence. Analyses controlled for baseline nicotine dependence, depressive symptoms, child age, and presence of other residential smokers.
RESULTS
Participants (n = 327) included 83% women and 83% African Americans. Multilevel AAR + counseling was associated with significantly higher levels of all four mediators (ps < .05). Baseline nicotine dependence (p < .05), 3-month self-efficacy (p < .05) and 12-month bioverified smoking abstinence (p < .001) related significantly to 12-month child cotinine outcome. The indirect effects of AAR + counseling intervention on cotinine via self-efficacy for child TSE protection and smoking abstinence (ps < .05) suggested mediation through these pathways.
CONCLUSIONS
Compared with AAR + control, multilevel AAR + counseling improved all putative mediators. Findings suggest that fostering TSE protection self-efficacy during intervention and encouraging parental smoking abstinence may be key to promoting long-term child TSE-reduction in populations of smokers with elevated challenges to quitting smoking.
IMPLICATIONS
Pediatric harm reduction interventions to protect children of smokers from tobacco smoke have emerged to address tobacco-related health disparities in underserved populations. Low-income smokers experience greater tobacco-related disease burden and more difficulty with smoking behavior change in standard evidence-based interventions than the general population of smokers. Therefore, improving knowledge about putative behavioral mechanisms of smoking behavior change that results in lower child exposure risk could inform future intervention improvements.",2020,Multilevel AAR+counseling was associated with significantly higher levels of all four mediators (p's<.05).,"['Smoking parents were recruited from pediatric clinics in low-income communities and randomized into a', 'Participants (n=327) included 83% women and 83% African Americans', 'child cotinine at 12-month follow-up']","['AAR+counseling intervention', 'child tobacco smoke exposure (TSE', 'multilevel intervention including a pediatric clinic intervention framed in best clinical practice guidelines (""Ask, Advise, Refer [AAR]) plus individualized telephone counseling (AAR+counseling), or AAR+control']","['12-month child cotinine (TSE biomarker, criterion), and four mediators: 3-month end-of-treatment self-efficacy to protect children from TSE and smoking urge coping skills, and 12-month perceived program (intra-treatment) support and bioverified smoking abstinence', 'cotinine via self-efficacy for child TSE protection and smoking abstinence', 'Baseline nicotine dependence (p<.05), 3-month self-efficacy (p<.05) and 12-month bioverified smoking abstinence']","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke (substance)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0282451', 'cui_str': 'Clinical Practice Guideline'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}]",,0.0130209,Multilevel AAR+counseling was associated with significantly higher levels of all four mediators (p's<.05).,"[{'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Collins', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, PA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Lepore', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, PA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Winickoff', 'Affiliation': 'Department of Pediatrics, Harvard Medical School, Massachusetts General Hospital for Children, Boston MA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Sosnowski', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz175']
840,31907860,"Is tailored therapy based on antibiotic susceptibility effective ? a multicenter, open-label, randomized trial.","An effective eradication therapy of Helicobacter pylori (H. pylori) should be used for the first time. In this study, we assessed whether tailored therapy based on antibiotic susceptibility testing is more effective than traditional therapy. We also evaluated the factors that cause treatment failure in high-resistance areas. For this multicenter trial, we recruited 467 H. pylori-positive patients. The patients were randomly assigned to receive tailored triple therapy (TATT), tailored bismuth-containing quadruple therapy (TABQT), or traditional bismuth-containing quadruple therapy (TRBQT). For the TATT and TABQT groups, antibiotic selection proceeded via susceptibility testing using an agar-dilution test. The patients in the TRBQT group were given amoxicillin, clarithromycin, esomeprazole, and bismuth. Successful eradication was defined as a negative 13 C-urea breath test at least eight weeks after the treatment ended. Susceptibility testing was conducted using an agar-dilution test. The eradication rate was examined via intention-to-treat (ITT) and per-protocol (PP) analyses. The clarithromycin, levofloxacin, and metronidazole resistance rates were 26.12%, 28.69%, and 96.79%, respectively. Resistance against amoxicillin and furazolidone was rare. The eradication rates for TATT, TRBQT, and TABQT were 67.32%, 63.69%, and 85.99% in the ITT analysis (P 0.001) and 74.64%, 68.49%, and 91.22% in the PP analysis (P 0.001), respectively. The efficacy of TABQT was affected by clarithromycin resistance, and bismuth exerted a direct influence on TATT failure. TABQT was the most efficacious regimen for use in high-resistance regions, especially among clarithromycin-susceptible patients.",2020,"TABQT was the most efficacious regimen for use in high-resistance regions, especially among clarithromycin-susceptible patients.",['467 H. pylori-positive patients'],"['tailored triple therapy (TATT), tailored bismuth-containing quadruple therapy (TABQT), or traditional bismuth-containing quadruple therapy (TRBQT', 'amoxicillin, clarithromycin, esomeprazole, and bismuth', 'clarithromycin', 'TABQT', 'amoxicillin and furazolidone', 'clarithromycin, levofloxacin']","['metronidazole resistance rates', 'eradication rate', 'eradication rates for TATT, TRBQT, and TABQT', 'Successful eradication']","[{'cui': 'C4517784', 'cui_str': '467 (qualifier value)'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0016855', 'cui_str': 'Furazolidone'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",,0.0365362,"TABQT was the most efficacious regimen for use in high-resistance regions, especially among clarithromycin-susceptible patients.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Wenzhou Central Hospital, Wenzhou, 325000, China.'}, {'ForeName': 'Zhengchao', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': ""The People's Hospital of Ruian, Wenzhou, 325000, China.""}, {'ForeName': 'Dingsai', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': ""The Second People's Hospital of Cangnan, Wenzhou, 325802, China.""}, {'ForeName': 'Ningmin', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Zhiyuan Inspection Medical Institute, Hangzhou, 310009, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'Zhiyuan Inspection Medical Institute, Hangzhou, 310009, China.'}, {'ForeName': 'Lang', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': ""The First People's Hospital of Cangnan, Wenzhou, 325800, China.""}, {'ForeName': 'Zhencheng', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': ""The First People's Hospital of Pingyang, Wenzhou, 325400, China.""}, {'ForeName': 'Qingjie', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Wenzhou Central Hospital, Wenzhou, 325000, China.'}, {'ForeName': 'Jiansheng', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325000, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Infectious Disease Prevention and Control, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing, 102206, China. zhangjianzhong@icdc.cn.'}, {'ForeName': 'Youming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, 310003, China. zlym@zju.edu.cn.'}]",Frontiers of medicine,['10.1007/s11684-019-0706-8']
841,32429977,The effect of oxytocin vaginal gel on vaginal atrophy in postmenopausal women: a randomized controlled trial.,"BACKGROUND
Around 90% of postmenopausal women are suffering from vaginal atrophy. This study aimed to evaluate the effect of oxytocin vaginal gel on vaginal atrophy among postmenopausal women.
METHODS
This was a randomized controlled trial that was conducted on 96 postmenopausal women who suffered from vaginal atrophy. The inclusion criteria were: literate women, age 40-60, at least 1 year passed from their last menstrual period or the level of FSH > 40 IU, monogamous women with the sexual relationship. Women in the intervention group, requested to use one applicator of 400 IU oxytocin gel per night and women in the placebo group used placebo each night. The subjective symptoms of vaginal atrophy, vaginal PH, maturation index were measured before and after the intervention.
RESULTS
The number of superficial cells was increased significantly in the oxytocin group compared to placebo (38.7 ± 7.18 vs. 3.69 ± 2.76, p = 0.0001), while the number of parabasal cells was decreased significantly in the oxytocin compared to placebo after the intervention. The improvement of the maturation index was more dominant in the oxytocin group (increased from 7.76 ± 4.68 to 52.48 ± 7.54) in comparison to the placebo group (increased from 8.58 ± 4.35 to 13.25 ± 5.06). The PH of the vagina decreased significantly in the oxytocin group in comparison to the placebo group (p = 0.0001). After 8 weeks, 88.6 and 7.1% of women in the oxytocin and placebo groups did not show the severe symptoms of vaginal atrophy (p = 0.001).
CONCLUSION
The results of this study showed that eight- week intervention with oxytocin vaginal gel (400 IU) could significantly improve the vaginal maturation index, subjective symptoms of vaginal atrophy and reduce the PH of the vagina. Using this medication in women who have a contraindication for hormone therapy is recommended.
TRIAL REGISTRATION
IRCT20160602028220N2.",2020,"The number of superficial cells was increased significantly in the oxytocin group compared to placebo (38.7 ± 7.18 vs. 3.69 ± 2.76, p = 0.0001), while the number of parabasal cells was decreased significantly in the oxytocin compared to placebo after the intervention.","['96 postmenopausal women who suffered from vaginal atrophy', 'women who have a contraindication for hormone therapy is recommended', 'The inclusion criteria were: literate women, age 40-60, at least 1 year passed from their last menstrual period or the level of FSH\u2009>\u200940\u2009IU, monogamous women with the sexual relationship', 'postmenopausal women', 'postmenopausal women are suffering from vaginal atrophy']","['placebo', 'oxytocin vaginal gel', 'oxytocin', 'oxytocin gel per night and women in the placebo']","['maturation index', 'vaginal maturation index, subjective symptoms of vaginal atrophy and reduce the PH of the vagina', 'vaginal atrophy', 'severe symptoms of vaginal atrophy', 'number of superficial cells', 'number of parabasal cells', 'subjective symptoms of vaginal atrophy, vaginal PH, maturation index', 'PH of the vagina']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0241616', 'cui_str': 'Atrophy of vagina'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0425932', 'cui_str': 'Date of last menstrual period'}, {'cui': 'C0558125', 'cui_str': 'Monogamous'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0042257', 'cui_str': 'Vaginal gel'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0241616', 'cui_str': 'Atrophy of vagina'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}]",96.0,0.337173,"The number of superficial cells was increased significantly in the oxytocin group compared to placebo (38.7 ± 7.18 vs. 3.69 ± 2.76, p = 0.0001), while the number of parabasal cells was decreased significantly in the oxytocin compared to placebo after the intervention.","[{'ForeName': 'Ilnaz', 'Initials': 'I', 'LastName': 'Zohrabi', 'Affiliation': 'Menopause Andropause Research Center, Midwifery Department, Nursing & Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Abedi', 'Affiliation': 'Menopause Andropause Research Center, Midwifery Department, Nursing & Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran. parvinabdei@ymail.com.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'Menopause Andropause Research Center, Midwifery Department, Nursing & Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Maraghi', 'Affiliation': 'Department of Biostatistics and Epidemiology, Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Shakiba Maram', 'Affiliation': 'Pharmaceutics Department, Nanotechnology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Houshmand', 'Affiliation': 'Department of Pharmacology, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}]",BMC women's health,['10.1186/s12905-020-00935-5']
842,31411650,Concerns About Potential Bias in a Randomized Clinical Trial of Integrated Prolonged Exposure Therapy vs Seeking Safety Integrated Coping Skills Therapy.,,2019,,[],[],[],[],[],[],,0.0271737,,"[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Najavits', 'Affiliation': 'Treatment Innovations, Newton Centre, Massachusetts.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.2226']
843,31411645,Concerns About Potential Bias in a Randomized Clinical Trial of Integrated Prolonged Exposure Therapy vs Seeking Safety Integrated Coping Skills Therapy-Reply.,,2019,,[],[],[],[],[],[],,0.0258844,,"[{'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'National Center for PTSD, VA Medical Center, White River Junction, Vermont.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.2229']
844,32429917,Reducing cardiometabolic risk in adults with a low socioeconomic position: protocol of the Supreme Nudge parallel cluster-randomised controlled supermarket trial.,"BACKGROUND
Unhealthy lifestyle behaviours such as unhealthy dietary intake and insufficient physical activity (PA) tend to cluster in adults with a low socioeconomic position (SEP), putting them at high cardiometabolic disease risk. Educational approaches aiming to improve lifestyle behaviours show limited effect in this population. Using environmental and context-specific interventions may create opportunities for sustainable behaviour change. In this study protocol, we describe the design of a real-life supermarket trial combining nudging, pricing and a mobile PA app with the aim to improve lifestyle behaviours and lower cardiometabolic disease risk in adults with a low SEP.
METHODS
The Supreme Nudge trial includes nudging and pricing strategies cluster-randomised on the supermarket level, with: i) control group receiving no intervention; ii) group 1 receiving healthy food nudges (e.g., product placement or promotion); iii) group 2 receiving nudges and pricing strategies (taxing of unhealthy foods and subsidizing healthy foods). In collaboration with a Dutch supermarket chain we will select nine stores located in low SEP neighbourhoods, with the nearest competitor store at > 1 km distance and managed by a committed store manager. Across the clusters, a personalized mobile coaching app targeting walking behaviour will be randomised at the individual level, with: i) control group; ii) a group receiving the mobile PA app. All participants (target n = 1485) should be Dutch-speaking, aged 45-75 years with a low SEP and purchase more than half of their household grocery shopping at the selected supermarkets. Participants will be recruited via advertisements and mail-invitations followed by community-outreach methods. Primary outcomes are changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake after 12 months follow-up. Secondary outcomes are changes in diastolic blood pressure, blood lipid markers, waist circumference, steps per day, and behavioural factors including healthy food purchasing, food decision style, social cognitive factors related to nudges and to walking behaviours and customer satisfaction after 12 months follow-up. The trial will be reflexively monitored to support current and future implementation.
DISCUSSION
The findings can guide future research and public health policies on reducing lifestyle-related health inequalities, and contribute to a supermarket-based health promotion intervention implementation roadmap.
TRIAL REGISTRATION
Dutch Trial Register ID NL7064, 30th of May, 2018.",2020,"Primary outcomes are changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake after 12 months follow-up.","['adults with a low socioeconomic position', 'The Supreme Nudge trial includes nudging and pricing strategies cluster-randomised on the supermarket level, with: i', 'adults with a low SEP', 'All participants (target n\xa0=\u20091485) should be Dutch-speaking, aged 45-75\u2009years with a low SEP and purchase more than half of their household grocery shopping at the selected supermarkets', 'Participants will be recruited via advertisements and mail-invitations followed by community-outreach methods', 'adults with a low socioeconomic position (SEP), putting them at high cardiometabolic disease risk']","['control group receiving no intervention; ii) group 1 receiving healthy food nudges (e.g., product placement or promotion); iii) group 2 receiving nudges and pricing strategies (taxing of unhealthy foods and subsidizing healthy foods']","['changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake', 'changes in diastolic blood pressure, blood lipid markers, waist circumference, steps per day, and behavioural factors including healthy food purchasing, food decision style, social cognitive factors related to nudges and to walking behaviours and customer satisfaction', 'cardiometabolic risk', 'lifestyle behaviours']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033118', 'cui_str': 'Pricing'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0282110', 'cui_str': 'Community Outreach'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0033118', 'cui_str': 'Pricing'}, {'cui': 'C0039371', 'cui_str': 'Tax'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009827', 'cui_str': 'Consumer Satisfaction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]",,0.122374,"Primary outcomes are changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake after 12 months follow-up.","[{'ForeName': 'Josine M', 'Initials': 'JM', 'LastName': 'Stuber', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands. j.stuber@amsterdamumc.nl.'}, {'ForeName': 'Joreintje D', 'Initials': 'JD', 'LastName': 'Mackenbach', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Femke E', 'Initials': 'FE', 'LastName': 'de Boer', 'Affiliation': 'Department of Social, Health and Organizational Psychology, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'de Bruijn', 'Affiliation': 'Amsterdam School of Communication Research ASCoR, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Gillebaart', 'Affiliation': 'Department of Social, Health and Organizational Psychology, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Marjolein C', 'Initials': 'MC', 'LastName': 'Harbers', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Jody C', 'Initials': 'JC', 'LastName': 'Hoenink', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Michel C A', 'Initials': 'MCA', 'LastName': 'Klein', 'Affiliation': 'Social AI group, department of Computer Science, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cédric N H', 'Initials': 'CNH', 'LastName': 'Middel', 'Affiliation': 'Athena Institute, Faculty of Science, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Yvonne T', 'Initials': 'YT', 'LastName': 'van der Schouw', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Tjerk Jan', 'Initials': 'TJ', 'LastName': 'Schuitmaker-Warnaar', 'Affiliation': 'Athena Institute, Faculty of Science, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Velema', 'Affiliation': 'Netherlands Nutrition Centre (Voedingscentrum), The Hague, The Netherlands.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Vos', 'Affiliation': 'Amsterdam School of Communication Research ASCoR, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Wilma E', 'Initials': 'WE', 'LastName': 'Waterlander', 'Affiliation': 'Department of Public Health, Amsterdam Public Health research institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Lakerveld', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Joline W J', 'Initials': 'JWJ', 'LastName': 'Beulens', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}]",Nutrition journal,['10.1186/s12937-020-00562-8']
845,18176356,Pertinence of a pre-colonoscopy consultation for routine information delivery.,"AIM OF THE STUDY
The purpose of this study was to determine whether patients have a better level of information about colonoscopy and are more satisfied with medical care when they attend a dedicated consultation with a gastroenterologist prior to the procedure.
METHODS
We conducted a prospective study which compared ""exposed"" (E) and ""non exposed"" (NE) patients. In group E, information about colonoscopy was delivered by a gastroenterologist during a special consultation at least 24 hours before the procedure. In group NE, information was delivered in the usual manner. The patients' level of information was measured after colonoscopy and 3 months later.
RESULTS
Thirteen patients were included in group E and 18 in group NE. The level of information was better in group E, 5.2 +/- 2.1 versus 3.3 +/- 2.1 (P<0.04), as was satisfaction with medical care, 24.9 +/- 4.6 versus 23.0 +/- 5.1 (P<0.03). The differences in information levels remained at 3 months.
CONCLUSION
The information delivered during a dedicated precolonoscopy consultation increases assimilation of knowledge concerning the procedure and the patient's satisfaction with medical care.",2007,"The level of information was better in group E, 5.2 +/-",['Thirteen patients were included in group E and 18 in group NE'],"['exposed"" (E) and ""non exposed"" (NE', 'precolonoscopy consultation']","['level of information', 'information levels']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441839', 'cui_str': 'Group E (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",13.0,0.0515696,"The level of information was better in group E, 5.2 +/-","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vignally', 'Affiliation': 'Laboratoire de santé publique, Faculté de médecine, Marseille. pascal.vignally@ap-hm.tr'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Gentile', 'Affiliation': ''}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Grimaud', 'Affiliation': ''}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Ousset', 'Affiliation': ''}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Vitton', 'Affiliation': ''}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Sambuc', 'Affiliation': ''}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Grimaud', 'Affiliation': ''}]",Gastroenterologie clinique et biologique,[]
846,31567287,"CORR Insights®: Does Robotic-assisted TKA Result in Better Outcome Scores or Long-Term Survivorship Than Conventional TKA? A Randomized, Controlled Trial.",,2020,,[],['CORR Insights®'],[],[],[],[],,0.24247,,"[{'ForeName': 'Lawrence D', 'Initials': 'LD', 'LastName': 'Dorr', 'Affiliation': 'L. D. Dorr, Dorr Institute for Research and Education, Pasadena, CA, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000969']
847,31843945,Efficacy and Safety of Dapagliflozin in the Elderly: Analysis From the DECLARE-TIMI 58 Study.,"OBJECTIVE
Data regarding the effects of sodium-glucose cotransporter 2 inhibitors in the elderly (age ≥65 years) and very elderly (age ≥75 years) are limited.
RESEARCH DESIGN AND METHODS
The Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 assessed cardiac and renal outcomes of dapagliflozin versus placebo in patients with type 2 diabetes. Efficacy and safety outcomes were studied within age subgroups for treatment effect and age-based treatment interaction.
RESULTS
Of the 17,160 patients, 9,253 were <65 years of age, 6,811 ≥65 to <75 years, and 1,096 ≥75 years. Dapagliflozin reduced the composite of cardiovascular death or hospitalization for heart failure consistently, with a hazard ratio (HR) of 0.88 (95% CI 0.72, 1.07), 0.77 (0.63, 0.94), and 0.94 (0.65, 1.36) in age-groups <65, ≥65 to <75, and ≥75 years, respectively (interaction P value 0.5277). Overall, dapagliflozin did not significantly decrease the rates of major adverse cardiovascular events, with HR 0.93 (95% CI 0.81, 1.08), 0.97 (0.83, 1.13), and 0.84 (0.61, 1.15) in age-groups <65, ≥65 to <75, and ≥75 years, respectively (interaction P value 0.7352). The relative risk reduction for the secondary prespecified cardiorenal composite outcome ranged from 18% to 28% in the different age-groups with no heterogeneity. Major hypoglycemia was less frequent with dapagliflozin versus placebo, with HR 0.97 (95% CI 0.58, 1.64), 0.50 (0.29, 0.84), and 0.68 (0.29, 1.57) in age-groups <65, ≥65 to <75, and ≥75 years, respectively (interaction P value 0.2107). Safety outcomes, including fractures, volume depletion, cancer, urinary tract infections, and amputations were balanced with dapagliflozin versus placebo, and acute kidney injury was reduced, all regardless of age. Genital infections that were serious or led to discontinuation of the study drug and diabetic ketoacidosis were uncommon, yet more frequent with dapagliflozin versus placebo, without heterogeneity (interaction P values 0.1058 and 0.8433, respectively).
CONCLUSIONS
The overall efficacy and safety of dapagliflozin are consistent regardless of age.",2020,"Major hypoglycemia was less frequent with dapagliflozin versus placebo, with HR 0.97","['elderly (age ≥65 years) and very elderly (age ≥75 years', ' 9,253 were <65 years of age, 6,811 ≥65 to <75 years, and 1,096 ≥75 years', 'Elderly', 'patients with type 2 diabetes', '17,160 patients']","['Dapagliflozin', 'sodium-glucose cotransporter 2 inhibitors', 'dapagliflozin', 'dapagliflozin versus placebo']","['composite of cardiovascular death or hospitalization for heart failure', 'Cardiovascular Events', 'Efficacy and safety outcomes', 'rates of major adverse cardiovascular events', 'Major hypoglycemia', 'Safety outcomes, including fractures, volume depletion, cancer, urinary tract infections, and amputations were balanced with dapagliflozin versus placebo, and acute kidney injury', 'relative risk reduction', 'overall efficacy and safety', 'Efficacy and Safety']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0646415,"Major hypoglycemia was less frequent with dapagliflozin versus placebo, with HR 0.97","[{'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel avivit@hadassah.org.il.'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Rozenberg', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Yanuv', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Goodrich', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, U.K.'}, {'ForeName': 'Ingrid A M', 'Initials': 'IAM', 'LastName': 'Gause-Nilsson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fredriksson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Johansson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}]",Diabetes care,['10.2337/dc19-1476']
848,31631481,Outcomes of single vs double surgeon for bilateral mastectomies.,,2020,,[],[],[],[],[],[],,0.372915,,"[{'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Schlegel', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Arsalan', 'Initials': 'A', 'LastName': 'Salamat', 'Affiliation': ""Division of Surgical Oncology, Department of Surgery, Magee-Women's Hospital, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Tane', 'Affiliation': ""Division of Surgical Oncology, Department of Surgery, Magee-Women's Hospital, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Joanna S', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': ""Division of Surgical Oncology, Department of Surgery, Magee-Women's Hospital, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Johnson', 'Affiliation': ""Division of Surgical Oncology, Department of Surgery, Magee-Women's Hospital, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Atilla', 'Initials': 'A', 'LastName': 'Soran', 'Affiliation': ""Division of Surgical Oncology, Department of Surgery, Magee-Women's Hospital, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.""}]",The breast journal,['10.1111/tbj.13664']
849,31883874,The addition of a humidifier device to a circuit and its impact on home ventilator performance: a bench study.,"INTRODUCTION AND OBJECTIVES
Humidification and non-invasive ventilation are frequently used together, despite the lack of precise recommendations regarding this practice. We aimed to analyse the impact of active external and built-in humidifiers on the performance of home ventilators, focusing on their pressurization efficacy and their behaviour under different inspiratory efforts.
METHODS
We designed a bench study of a lung simulator programmed to emulate mechanical conditions similar to those experienced by real respiratory patients and to simulate three different levels of inspiratory effort: five different commonly used home NIV devices and active humidifiers attached to the latter (internal or ""built-in"") or to the circuit (external). To test ventilator pressurization under different humidification and effort settings, pressure-time products in the first 300ms and 500ms of the respiratory cycle were calculated in the 45 situations simulated. Inferential statistical analysis was performed.
RESULTS
A significant reduction of PTP 300 and PTP 500 was observed with the external humidifier in three of the devices. The same pattern was noted for another device with an internal humidifier, and only one device showed no significant changes. This impact on pressurization was commonly higher under high inspiratory effort.
CONCLUSIONS
These results indicate the need to monitor pressure changes in the use of external humidification devices in some home NIV ventilators.",2020,A significant reduction of PTP 300 and PTP 500 was observed with the external humidifier in three of the devices.,[],"['home NIV devices and active humidifiers attached to the latter (internal or ""built-in"") or to the circuit (external']",[],[],"[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0181232', 'cui_str': 'Humidifiers'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}]",[],,0.0317588,A significant reduction of PTP 300 and PTP 500 was observed with the external humidifier in three of the devices.,"[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Collada-Carrasco', 'Affiliation': 'Hospital Universitario Doce De Octubre, Madrid, Spain. Electronic address: javiercollada91@gmail.com.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lamolda-Puyol', 'Affiliation': 'Hospital Parc Taulí De Sabadell, Barcelona, Spain. Electronic address: clalmolda@tauli.cat.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Luján', 'Affiliation': 'Hospital Parc Taulí De Sabadell, Barcelona, Spain. Electronic address: mlujan@tauli.cat.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Castaño-Menéndez', 'Affiliation': 'Hospital Universitario Doce De Octubre, Madrid, Spain. Electronic address: albacm1991@gmail.com.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Jiménez-Gómez', 'Affiliation': 'Hospital Universitario Doce De Octubre, Madrid, Spain. Electronic address: migueljimenezgomez@gmail.com.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Hernández-Voth', 'Affiliation': 'Hospital Universitario Doce De Octubre, Madrid, Spain. Electronic address: anahvoth@gmail.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sayas-Catalán', 'Affiliation': 'Hospital Universitario Doce De Octubre, Madrid, Spain. Electronic address: jsayascat@gmail.com.'}]",Pulmonology,['10.1016/j.pulmoe.2019.11.004']
850,32432448,Game-based versus multilateral approach: effects of a 12-week program on motor skill acquisition and physical fitness development in soccer school children.,"BACKGROUND
The purpose of this study was to investigate the effects of a 12-week-game-based training versus a traditional multilateral approach on motor skills acquisition and physical fitness, in a group of U9 children playing soccer.
METHODS
Forty children aged 9 or younger (U9) recruited from a local soccer school were assigned in a 1:1 ratio to a game-based training program (GB) or a multilateral training (MA) approach. The training programs lasted 12 weeks, and players were tested at baseline and at the end of the program (12-week follow-up). The outcomes were: standing long jump test, shuttle dribble test, 10×5 shuttle run test and Mini-Cooper test.
RESULTS
Within-group comparisons showed statistically-significant improvements in both of the groups: standing long lump (P<0.0001), shuttle dribble test (P<0.0001), shuttle run test (P<0.0001) and Mini-Cooper test (P<0.0001). Furthermore, the MA group showed better performance in the shuttle run test after 12 weeks of training compared to the GB group (P=0.0002; +8%).
CONCLUSIONS
A multilateral approach promotes physical development in U9 soccer players without affecting learning of-soccer skills. Therefore, a multilateral approach should be included in soccer training programs to ensure an optimal development in young soccer players.",2020,"Furthermore, the MA group showed better performance in the shuttle run test after 12 weeks of training compared to the GB group (p= 0.0002; +8%).
","['U9 soccer players without affecting learning of soccer skills', '40 Children 9 years old or younger (U9) recruited from a local soccer school', 'soccer school children', 'young soccer players', 'U9 children playing soccer']","['12-week- game-based training versus a traditional multilateral approach', 'game-based training program (GB) or a multilateral training (MA) approach']","['shuttle dribble test', 'motor skill acquisition and physical fitness development', 'motor skills acquisition and physical fitness', 'standing long jump test, shuttle dribble test, 10x5 shuttle run test and Mini-Cooper test', 'standing long lump']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0013132', 'cui_str': 'Dribbling from mouth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0335912', 'cui_str': 'Cooper'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",40.0,0.020152,"Furthermore, the MA group showed better performance in the shuttle run test after 12 weeks of training compared to the GB group (p= 0.0002; +8%).
","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Abate Daga', 'Affiliation': 'Department of Medical Sciences, University of Turin, Turin, Italy - federico.abatedaga@unito.it.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Baseggio', 'Affiliation': 'Department of Medical Sciences, School of Exercise and Sport Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Gollin', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Beratto', 'Affiliation': 'Department of Medical Sciences, School of Exercise and Sport Sciences, University of Turin, Turin, Italy.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10726-6']
851,31519167,Effects of dietary intervention on vitamin B 12 status and cognitive level of 18-month-old toddlers in high-poverty areas: a cluster-randomized controlled trial.,"BACKGROUND
The local diet in high-poverty areas in China is mainly vegetarian, and children may be more vulnerable to vitamin B 12 deficiency.
OBJECTIVE
The aims of this study were to explore the vitamin B 12 status of toddlers living in high-poverty areas of China and to observe the effects of different complementary foods on the vitamin B 12 status and cognitive level of these toddlers.
METHODS
The study was nested within a cluster-randomized controlled trial implemented in 60 administrative villages (clusters) of Xichou County in which infants aged 6 months old were randomized to receive 50 g/d of pork (meat group), an equi-caloric fortified cereal supplement (fortified cereal group) or local cereal supplement (local cereal group) for one year. At 18 months, a subsample of the 180 toddlers (60 from each group) was randomly tested for serum vitamin B 12 and total homocysteine (tHcy) levels, and their neurodevelopment was evaluated.
RESULTS
The median serum concentrations of vitamin B 12 and tHcy were 360.0 pg/mL and 8.2 μmol/L, respectively, in children aged 18 months. Serum vitamin B 12 concentrations less than 300 pg/mL were found in 62 (34.4%) children, and concentrations less than 200 pg/mL were found in 30 (16.7%) children. The median vitamin B 12 concentration was significantly different among the three groups (P < 0.001). The highest vitamin B 12 level was demonstrated in the fortified cereal group (509.5 pg/mL), followed by the meat group (338.0 pg/mL) and the local cereal group (241.0 pg/mL). Vitamin B 12 concentration was positively correlated with the cognitive score (P < 0.001) and the fine motor score (P = 0.023) of the Bayley Scales of Infant Development, 3rd Edition (BSID III) screening test. Compared to the local cereal group, children in the meat group had higher cognitive scores (P < 0.05).
CONCLUSION
In poor rural areas of China, vitamin B 12 deficiency in toddlers was common due to low dietary vitamin B 12 intake. Fortified cereal and meat could help improve the vitamin B 12 status of children and might improve their cognitive levels.
TRIAL REGISTRATION
The larger trial in which this study was nested was registered at clinical trials.gov as NCT00726102 . It was registered on July 31, 2008.",2019,"Compared to the local cereal group, children in the meat group had higher cognitive scores (P < 0.05).
","['At 18\u2009months, a subsample of the 180 toddlers (60 from each group', 'vitamin B 12 status and cognitive level of 18-month-old toddlers in high-poverty areas', '60 administrative villages (clusters) of Xichou County in which infants aged 6\u2009months old', 'B 12 status of toddlers living in high-poverty areas of China']","['50\u2009g/d of pork (meat group), an equi-caloric fortified cereal supplement (fortified cereal group) or local cereal supplement (local cereal group', 'Fortified cereal and meat', 'vitamin', 'dietary intervention']","['fine motor score', 'median serum concentrations of vitamin B 12 and tHcy', 'serum vitamin B 12 and total homocysteine (tHcy) levels', 'cognitive score', 'higher cognitive scores', 'Bayley Scales of Infant Development, 3rd Edition (BSID III) screening test', 'median vitamin B 12 concentration', 'Serum vitamin B 12 concentrations less']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032855', 'cui_str': 'Poverty Areas'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0452867', 'cui_str': 'Pork'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0007757', 'cui_str': 'Cereal Grain'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}]","[{'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}]",60.0,0.1209,"Compared to the local cereal group, children in the meat group had higher cognitive scores (P < 0.05).
","[{'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Sheng', 'Affiliation': ""Department of Children and Adolescents Health Care, Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute for Pediatric Research, MOE-Shanghai Key Laboratory of Children's Environmental Health, No.1665, Kongjiang Road, Yangpu District, Shanghai, 200092, China.""}, {'ForeName': 'Junli', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Children and Adolescents Health Care, Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute for Pediatric Research, MOE-Shanghai Key Laboratory of Children's Environmental Health, No.1665, Kongjiang Road, Yangpu District, Shanghai, 200092, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Department of Children and Adolescents Health Care, Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute for Pediatric Research, MOE-Shanghai Key Laboratory of Children's Environmental Health, No.1665, Kongjiang Road, Yangpu District, Shanghai, 200092, China.""}, {'ForeName': 'Fengxiu', 'Initials': 'F', 'LastName': 'Ouyang', 'Affiliation': ""Ministry of Education and Shanghai Key Laboratory of Children's Environmental Health, Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, No.1665, Kongjiang Road, Yangpu District, Shanghai, 200092, China.""}, {'ForeName': 'Jingqiu', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Shanghai Institute for Pediatric Research, Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Key Laboratory of Pediatric Gastroenterology and Nutrition, No.1665, Kongjiang Road, Yangpu District, Shanghai, 200092, China. majingqiu@xinhuamed.com.cn.'}]",BMC pediatrics,['10.1186/s12887-019-1716-z']
852,31927698,Real-World Data and Randomised Controlled Trials: The Salford Lung Study.,"Traditional efficacy double-blind randomised controlled trials (DBRCTs) measure the benefit a treatment produces under near-ideal test conditions in highly selected patient populations; however, the behaviour of patients and investigators in such trials is highly controlled, highly compliant and adherent, and non-representative of routine clinical practice. Pragmatic effectiveness trials measure the benefit a treatment produces in patients in everyday ""real-world"" practice. Ideally, effectiveness trials should recruit patients as similar as possible to those who will ultimately be prescribed the medicine, and create freedom within the study design to allow normal behaviours of patients and healthcare professionals (HCPs) to be expressed. The Salford Lung Study (SLS) was a world-first, prospective, phase III, pragmatic randomised controlled trial (RCT) programme in patients with chronic obstructive pulmonary disease and asthma to evaluate the effectiveness of a pre-licensed medication (fluticasone furoate/vilanterol) in real-world practice using electronic health records and through collaboratively engaging general practitioners and community pharmacists in clinical research. The real-world aspect of SLS was unique, requiring careful planning and attention to the goals of maximising the external validity of the trials while maintaining scientific rigour and securing suitable electronic processes for proper interpretation of safety data. Key learnings from SLS that may inform the design of future pragmatic effectiveness RCTs include: (1) ensuring the trial setting and operational infrastructure are aligned with routine clinical care; (2) recruiting a broad patient population with characteristics as close as possible to patients in routine clinical practice, to maximise the generalisability and applicability of trial results; (3) ensuring that patients and HCPs are suitably engaged in the trial, to maximise the chances of successful trial delivery; and (4) careful study design, incorporating outcomes of value to patients, HCPs, policymakers and payers, and using pre-planned analyses to address scientifically valid research hypotheses to ensure robustness of the trial data.",2020,"Traditional efficacy double-blind randomised controlled trials (DBRCTs) measure the benefit a treatment produces under near-ideal test conditions in highly selected patient populations; however, the behaviour of patients and investigators in such trials is highly controlled, highly compliant and adherent, and non-representative of routine clinical practice.","['patients with chronic obstructive pulmonary disease and asthma', 'highly selected patient populations', 'patients in everyday ""real-world"" practice']",['pre-licensed medication (fluticasone furoate/vilanterol'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}]",[],,0.228398,"Traditional efficacy double-blind randomised controlled trials (DBRCTs) measure the benefit a treatment produces under near-ideal test conditions in highly selected patient populations; however, the behaviour of patients and investigators in such trials is highly controlled, highly compliant and adherent, and non-representative of routine clinical practice.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Leather', 'Affiliation': 'Global Respiratory Franchise, GlaxoSmithKline plc., Brentford, Middlesex, UK. david.a.leather@gsk.com.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Community and Primary Health Care, Faculty of Health, Plymouth University, Plymouth, UK.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Woodcock', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre, The University of Manchester and Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre, The University of Manchester and Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Jacques', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline plc., Uxbridge, Middlesex, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}]",Advances in therapy,['10.1007/s12325-019-01192-1']
853,31631788,Effects of Varied Surgical Simulation Training Schedules on Motor-Skill Acquisition.,"There have been many studies to evaluate the effect of training schedules on retention; however, these usually compare only 2 drastically different schedules, massed and distributed, and they have tended to look at declarative knowledge tasks. This study examined learning on a laparoscopic surgery simulator using a set of procedural or perceptual-motor tasks with some declarative elements. The study used distributed, massed, and 2 hybrid-training schedules that are neither distributed nor massed. To evaluate the training schedules, 23 participants with no previous laparoscopic experience were recruited and randomly assigned to 1 of the 4 training schedules. They performed 3 laparoscopic training tasks in eight 30-minute learning sessions. We compared how task time decreased with each schedule in a between-participants design. We found participants in all groups demonstrated a decrease in task completion time as the number of training sessions increased; however, there were no statistically significant differences in participants' improvement on task completion time between the 4 different training schedule groups, which suggested that time on task is more important for learning these tasks than the training schedule.",2020,"We found participants in all groups demonstrated a decrease in task completion time as the number of training sessions increased; however, there were no statistically significant differences in participants' improvement on task completion time between the 4 different training schedule groups, which suggested that time on task is more important for learning these tasks than the training schedule.",['23 participants with no previous laparoscopic experience'],['Varied Surgical Simulation Training'],"['task completion time', 'Motor-Skill Acquisition']","[{'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",23.0,0.0260604,"We found participants in all groups demonstrated a decrease in task completion time as the number of training sessions increased; however, there were no statistically significant differences in participants' improvement on task completion time between the 4 different training schedule groups, which suggested that time on task is more important for learning these tasks than the training schedule.","[{'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Ritter', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Martin K-C', 'Initials': 'MK', 'LastName': 'Yeh', 'Affiliation': 'The Pennsylvania State University-Brandywine, Media, PA, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Ka-Chun', 'Initials': 'KC', 'LastName': 'Siu', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Oleynikov', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, USA.'}]",Surgical innovation,['10.1177/1553350619881591']
854,32014293,"Comparing the effectiveness of simulation as adjuncts to standardized lectures, on the identification and reporting of intimidation during surgical clerkship: A mixed method randomized controlled trial.","BACKGROUND
Intimidation constitutes a learning barrier for undergraduates and its reporting rate to authorities remains suboptimal.
METHODS
A randomized controlled trial was conducted to evaluate the effectiveness of three interventions designed to increase reporting by undergraduates during their surgical rotation. As adjuncts to a standardized lecture, participants were assigned to a simulated intimidation scenario, a video of intimidation events, or a control group. Surveys were completed before the interventions, and at the end of the rotation.
RESULTS
Of the 119 included participants, 17.6% reported that they had been intimidated during their previous rotation as compared to 37.0% after the surgical rotation. There were no statistically significant differences in the reporting of intimidation between the groups. However, 65.5% of all participants declared feeling more at ease to report intimidation, yet the reporting rate remained low.
CONCLUSION
Intimidation during clerkship persists as a frequent problem although the best method to increase its reporting remains unclear.",2020,There were no statistically significant differences in the reporting of intimidation between the groups.,['Of the 119 included participants'],[],[],"[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],[],119.0,0.109104,There were no statistically significant differences in the reporting of intimidation between the groups.,"[{'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Thivierge-Southidara', 'Affiliation': 'Faculty of Medicine, Université de Montréal, Canada; Faculty of Medicine, Université Laval, Canada. Electronic address: maureen.thivierge-southidara@umontreal.ca.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Rodriguez-Qizilbash', 'Affiliation': 'Faculty of Medicine, Université de Montréal, Canada; Faculty of Medicine, McGill University, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vincelette', 'Affiliation': 'School of Nursing, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Canada; Research Centre Charles-Le-Moyne-Saguenay-Lac-Saint-Jean sur les innovations en santé, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Dubrowski', 'Affiliation': ""Canada Research Chair in HealthCare Simulation, Ontario Tech University, Faculty of Health Sciences, Canada; Department of Education and CHUM Academy, Centre Hospitalier de l'Université de Montréal, Canada.""}, {'ForeName': 'Kerianne', 'Initials': 'K', 'LastName': 'Boulva', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Canada; Department of Surgery, Centre Hospitalier de l'Université de Montréal, Canada.""}, {'ForeName': 'Ramses', 'Initials': 'R', 'LastName': 'Wassef', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Canada; Department of Surgery, Centre Hospitalier de l'Université de Montréal, Canada.""}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Godbout', 'Affiliation': 'Faculty of Medicine, Université de Montréal, Canada; Department of Surgery, Hôpital Notre-Dame de Montréal, Canada.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Patocskai', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Canada; Department of Surgery, Centre Hospitalier de l'Université de Montréal, Canada.""}]",American journal of surgery,['10.1016/j.amjsurg.2020.01.025']
855,32427675,Allogenic Fecal Microbiota Transplantation in Patients With Nonalcoholic Fatty Liver Disease Improves Abnormal Small Intestinal Permeability: A Randomized Control Trial.,"INTRODUCTION
Nonalcoholic fatty liver disease (NAFLD) is an obesity-related disorder that is rapidly increasing in incidence and is considered the hepatic manifestation of the metabolic syndrome. The gut microbiome plays a role in metabolism and maintaining gut barrier integrity. Studies have found differences in the microbiota between NAFLD and healthy patients and increased intestinal permeability in patients with NAFLD. Fecal microbiota transplantation (FMT) can be used to alter the gut microbiome. It was hypothesized that an FMT from a thin and healthy donor given to patients with NAFLD would improve insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability.
METHODS
Twenty-one patients with NAFLD were recruited and randomized in a ratio of 3:1 to either an allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum. IR was calculated by HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability was tested using the lactulose:mannitol urine test. Additional markers of metabolic syndrome and the gut microbiota were examined. Patient visits occurred at baseline, 2, 6 weeks, and 6 months post-FMT.
RESULTS
There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT. Allogenic FMT patients with elevated small intestinal permeability (>0.025 lactulose:mannitol, n = 7) at baseline had a significant reduction 6 weeks after allogenic FMT.
DISCUSSION
FMT did not improve IR as measured by HOMA-IR or hepatic PDFF but did have the potential to reduce small intestinal permeability in patients with NAFLD.",2020,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"['Patients With Nonalcoholic Fatty Liver Disease Improves', 'patients with NAFLD', 'Twenty-one patients with NAFLD', 'Abnormal Small Intestinal Permeability']","['Allogenic Fecal Microbiota Transplantation', 'Fecal microbiota transplantation (FMT', 'allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum', 'FMT', 'allogenic or autologous FMT', 'Allogenic FMT']","['HOMA-IR or hepatic PDFF', 'Patient visits', 'intestinal permeability', 'insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability', 'small intestinal permeability', 'HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",21.0,0.0335215,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Craven', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nair Parvathy', 'Affiliation': ""Division of Infectious Disease, St. Joseph's Health Care, London, Ontario, Canada.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Beaton', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Silverman', 'Affiliation': 'Program in Computational Biology and Bioinformatics, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Qumosani', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hramiak', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hegele', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Tisha', 'Initials': 'T', 'LastName': 'Joy', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Meddings', 'Affiliation': 'Department of Medicine, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Urquhart', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Harvie', 'Affiliation': 'The Canadian Centre for Microbiome and Probiotic Research, London, Ontario, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McKenzie', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Reid', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Burton', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000661']
856,32119591,"Immunogenicity and safety of lyophilized and liquid dengue tetravalent vaccine candidate formulations in healthy adults: a randomized, phase 2 clinical trial.","Takeda has developed a live-attenuated dengue tetravalent vaccine candidate (TAK-003) which has been shown to be immunogenic with acceptable reactogenicity in phase 1 trials. In agreement with World Health Organization prequalification requirements for dengue vaccines, Takeda has manufactured a lyophilized formulation of TAK-003 that allows stable storage at +2°C to +8°C. This randomized, double-blind, phase 2 study (NCT02193087) was performed in 1002 healthy dengue-naïve adults, 18-49 years of age, across seven centers in the USA to compare the safety and immunogenicity of one or two doses of a lyophilized TAK-003 formulation with the liquid TAK-003 formulation used in previous phase 1 studies. The primary objective was to show immunologic equivalence in terms of geometric mean titers (GMT) of neutralizing antibodies to the four dengue serotypes one month after one dose of the lyophilized and liquid formulations. Secondary assessments were of safety and seropositivity rates, including after a second dose. The primary endpoint was not met, because immunologic equivalence after one dose was only shown for the DENV-2 serotype. Nonetheless, GMTs and seropositivity rates to all four serotypes were achieved with all formulations after two doses and are in line with what was observed in previous studies. Additionally, in view of the acceptable reactogenicity, with no vaccine-related serious adverse events reported, these data support continuing further clinical development of the lyophilized TAK-003 formulation.",2020,"Nonetheless, GMTs and seropositivity rates to all four serotypes were achieved with all formulations after two doses and are in line with what was observed in previous studies.","['1002 healthy dengue-naïve adults, 18-49\xa0years of age, across seven centers in the USA', 'healthy adults']","['lyophilized and liquid dengue tetravalent vaccine candidate formulations', 'lyophilized TAK-003 formulation with the liquid TAK-003 formulation']","['Immunogenicity and safety', 'safety and seropositivity rates', 'geometric mean titers (GMT) of neutralizing antibodies', 'immunologic equivalence', 'GMTs and seropositivity rates', 'safety and immunogenicity']","[{'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0312539', 'cui_str': 'Immunologic equivalence, function (observable entity)'}]",1002.0,0.159282,"Nonetheless, GMTs and seropositivity rates to all four serotypes were achieved with all formulations after two doses and are in line with what was observed in previous studies.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Turner', 'Affiliation': 'Advanced Clinical Research , Meridian, ID, USA.'}, {'ForeName': 'Athanasia', 'Initials': 'A', 'LastName': 'Papadimitriou', 'Affiliation': 'Takeda Pharmaceuticals International AG , Zurich, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Winkle', 'Affiliation': 'Anaheim Clinical Trials , Anaheim, CA, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Segall', 'Affiliation': 'Clinical Research Atlanta , Stockbridge, GA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Levin', 'Affiliation': 'Clinical Research Center of Nevada , Las Vegas, NV, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Doust', 'Affiliation': 'Hope Research Institute , Phoenix, AZ, USA.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'Johnson County Clin-Trials , Lenexa, KS, USA.'}, {'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Lucksinger', 'Affiliation': 'Tekton Research , Austin, TX, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fierro', 'Affiliation': 'Johnson County Clin-Trials , Lenexa, KS, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Pickrell', 'Affiliation': 'Tekton Research , Austin, TX, USA.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Raanan', 'Affiliation': 'Takeda Vaccines Inc ., Cambridge, MA, USA.'}, {'ForeName': 'Vianney', 'Initials': 'V', 'LastName': 'Tricou', 'Affiliation': 'Takeda Pharmaceuticals International AG , Zurich, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Borkowski', 'Affiliation': 'Takeda Pharmaceuticals International AG , Zurich, Switzerland.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'Takeda Vaccines Inc ., Cambridge, MA, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1727697']
857,31521794,"Evaluating the Effects of Acupuncture Using a Dental Pain Model in Healthy Subjects - A Randomized, Cross-Over Trial.","Acupuncture is a complementary and nonpharmacological intervention that can be effective for the management of chronic pain in addition to or instead of medication. Various animal models for neuropathic pain, inflammatory pain, cancer-related pain, and visceral pain already exist in acupuncture research. We used a newly validated human pain model and examined whether acupuncture can influence experimentally induced dental pain. For this study, we compared the impact of manual acupuncture (real acupuncture), manual stimulation of a needle inserted at nonacupuncture points (sham acupuncture) and no acupuncture on experimentally induced dental pain in 35 healthy men who were randomized to different sequences of all 3 interventions in a within-subject design. BORG CR10 pain ratings and autonomic responses (electrodermal activity and heart rate variability) were investigated. An initial mixed model with repeated measures included preintervention pain ratings and the trial sequence as covariates. The results showed that acupuncture was effective in reducing pain intensity when compared to no acupuncture (β = -.708, P = .002), corresponding to a medium Cohen's d effect size of .56. The comparison to the sham acupuncture revealed no statistically significant difference. No differences in autonomic responses between real and sham acupuncture were found during the intervention procedures. PERSPECTIVE: This study established a dental pain model for acupuncture research and provided evidence that experimentally induced dental pain can be influenced by either real acupuncture or manual stimulation of needles at nonacupuncture points. The data do not support that acupoint specificity is a significant factor in reducing experimental pain.",2020,"The results showed that acupuncture was effective in reducing pain intensity when compared to no acupuncture (β =-0.708, p = 0.002), corresponding to a medium Cohen's d effect size of 0.56.","['healthy subjects', 'thirty-five healthy men']","['manual acupuncture (real acupuncture), manual stimulation of a needle inserted at non-acupuncture points (sham acupuncture) and no acupuncture', 'acupuncture', 'Acupuncture']","['BORG CR10 pain ratings and autonomic responses (electrodermal activity and heart rate variability', 'preintervention pain ratings', 'autonomic responses', 'pain intensity', 'dental pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}]",35.0,0.186861,"The results showed that acupuncture was effective in reducing pain intensity when compared to no acupuncture (β =-0.708, p = 0.002), corresponding to a medium Cohen's d effect size of 0.56.","[{'ForeName': 'Nuno M P', 'Initials': 'NMP', 'LastName': 'de Matos', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University of Zurich and University Hospital Zurich, Zurich, Switzerland; Clinic of Cranio-Maxillofacial and Oral Surgery, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pach', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University of Zurich and University Hospital Zurich, Zurich, Switzerland; Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany. Electronic address: daniel.pach@uzh.ch.'}, {'ForeName': 'Jing Jing', 'Initials': 'JJ', 'LastName': 'Xing', 'Affiliation': 'First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Barth', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Lara Elena', 'Initials': 'LE', 'LastName': 'Beyer', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Xuemin', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kern', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Nenad', 'Initials': 'N', 'LastName': 'Lukic', 'Affiliation': 'Clinic of Cranio-Maxillofacial and Oral Surgery, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Dominik A', 'Initials': 'DA', 'LastName': 'Ettlin', 'Affiliation': 'Clinic of Cranio-Maxillofacial and Oral Surgery, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Brügger', 'Affiliation': 'Clinic of Cranio-Maxillofacial and Oral Surgery, Center of Dental Medicine, University of Zurich, Zurich, Switzerland; Institute for Biomedical Engineering, ETH Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Witt', 'Affiliation': 'Institute for Complementary and Integrative Medicine, University of Zurich and University Hospital Zurich, Zurich, Switzerland; Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany; Center for Integrative Medicine, University of Maryland School of Medicine Baltimore, Baltimore, Maryland.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.08.013']
858,31524140,The effect of a 4-week core strengthening program on determinants of wrestling performance in junior Greco-Roman wrestlers: A randomized controlled trial.,"BACKGROUND
Core-strength is vital for Greco-Roman wrestling, although studies have yet to establish the effectives of core-specific training in this sport.
OBJECTIVE
To examine the effect of core-specific strength training on determinants of Greco-Roman wrestling performance in elite junior athletes.
METHODS
Twenty state-level, junior, Greco-Roman wrestlers were randomized into a core-specific training group (COR; n= 12) and a control group (CON; n= 8). The COR group undertook a 4-week, core-specific training program concurrently with their typical training program, whilst the CON group completed 4 weeks of typical training only. Both groups completed overhead medicine ball throw (OMBT), Suplexes, bridges and medicine ball chest throw (MBCT) prior to and following the intervention.
RESULTS
The COR group demonstrated significantly greater improvement in bridges (p= 0.037; F= 5.046) and OMBT (p< 0.001; F= 26.43) than the CON group, with moderate to large between-group effect sizes (ES = 0.79-2.35). In addition, the effect size calculations were moderate-to-large (0.79-0.87) for Suplex and MBCT, with measures for the COR group greater than the CON group.
CONCLUSION
Accordingly, core-specific training programs should be combined with wrestling-specific conditioning programs to improve back and hip extensor performance in junior Greco-Roman wrestlers.",2020,"The COR group demonstrated significantly greater improvement in bridges (p= 0.037; F= 5.046) and OMBT (p< 0.001; F= 26.43) than the CON group, with moderate to large between-group effect sizes (ES = 0.79-2.35).","['Twenty state-level, junior', 'junior Greco-Roman wrestlers', 'elite junior athletes']","['core-specific strength training', '4-week core strengthening program', 'overhead medicine ball throw (OMBT), Suplexes, bridges and medicine ball chest throw (MBCT', 'core-specific training program concurrently with their typical training program, whilst the CON group completed 4 weeks of typical training only', 'CON']","['bridges', 'OMBT']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0560512', 'cui_str': 'Does throw (finding)'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1720467', 'cui_str': 'Only'}]","[{'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}]",20.0,0.0227928,"The COR group demonstrated significantly greater improvement in bridges (p= 0.037; F= 5.046) and OMBT (p< 0.001; F= 26.43) than the CON group, with moderate to large between-group effect sizes (ES = 0.79-2.35).","[{'ForeName': 'Vahid Valipour', 'Initials': 'VV', 'LastName': 'Dehnou', 'Affiliation': 'Sport Sciences Department, Faculty of Literature and Human Sciences, Lorestan University, Lorestan Province, Iran.'}, {'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Azadi', 'Affiliation': 'Sport Sciences Department, Faculty of Literature and Human Sciences, Lorestan University, Lorestan Province, Iran.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gahreman', 'Affiliation': 'College of Health and Human Sciences, Charles Darwin University, Darwin, Australia.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Doma', 'Affiliation': 'Sport and Exercise Science, College of Healthcare Sciences, James Cook University, Townsville, Australia.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181328']
859,32429848,A randomized trial of mail and email recruitment strategies for a physician survey on clinical trial accrual.,"BACKGROUND
Patient participation in cancer clinical trials is suboptimal. A challenge to capturing physicians' insights about trials has been low response to surveys. We conducted a study using varying combinations of mail and email to recruit a nationally representative sample of medical, surgical, and radiation oncologists to complete a survey on trial accrual.
METHODS
We randomly assigned eligible physicians identified from the American Medical Association MasterFile (n = 13,251) to mail- or email-based recruitment strategies. Mail-based recruitment included a survey packet with: (1) cover letter describing the survey and inviting participation; (2) paper copy of the survey and postage-paid return envelope; and (3) a web link for completing the survey online. Email-based recruitment included an e-mail describing the survey and inviting participation, along with the web link to the survey, and a reminder postcard 2 weeks later.
RESULTS
Response was higher for mail-based (11.8, 95% CI 11.0-12.6%) vs. email-based (4.5, 95% CI 4.0-5.0%) recruitment. In email-based recruitment, only one-quarter of recipients opened the email, and even fewer clicked on the link to complete the survey. Most physicians in mail-based recruitment responded after the first invitation (362 of 770 responders, 47.0%). A higher proportion of responders vs. non-responders were young (ages 25-44 years), men, and radiation or surgical (vs. medical) oncologists.
CONCLUSIONS
Most physicians assigned to mail-based recruitment actually completed the survey online via the link provided in the cover letter, and those in email-based recruitment did not respond until they received a reminder postcard by mail. Providing the option to return a paper survey or complete it online may have further increased participation in the mail-based group, and future studies should examine how combinations of delivery mode and return options affect physicians' response to surveys.",2020,"RESULTS
Response was higher for mail-based (11.8, 95% CI 11.0-12.6%) vs. email-based (4.5, 95% CI 4.0-5.0%) recruitment.","['A higher proportion of responders vs. non-responders were young (ages 25-44\u2009years), men, and radiation or surgical (vs. medical) oncologists']","['Mail-based recruitment included a survey packet with: (1) cover letter describing the survey and inviting participation; (2) paper copy of the survey and postage-paid return envelope; and (3) a web link for completing the survey online', 'mail and email recruitment strategies', 'American Medical Association MasterFile (n\u2009=\u200913,251) to mail- or email-based recruitment strategies']",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1641805', 'cui_str': 'Packet - unit of product usage'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0002461', 'cui_str': 'AMA - American Medical Association'}]",[],,0.0660322,"RESULTS
Response was higher for mail-based (11.8, 95% CI 11.0-12.6%) vs. email-based (4.5, 95% CI 4.0-5.0%) recruitment.","[{'ForeName': 'Caitlin C', 'Initials': 'CC', 'LastName': 'Murphy', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA. caitlin.murphy@utsouthwestern.edu.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Craddock Lee', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Geiger', 'Affiliation': 'Healthcare Delivery Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Cox', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Chul', 'Initials': 'C', 'LastName': 'Ahn', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Rasmi', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Halm', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'McCallister', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Celette Sugg', 'Initials': 'CS', 'LastName': 'Skinner', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}]",BMC medical research methodology,['10.1186/s12874-020-01014-x']
860,32107012,Training with cognitive load improves performance under similar conditions in a real surgical task.,"BACKGROUND
Enhancing cognitive load while performing a bimanual surgical task affects performance. Whether repeated training under this condition could benefit performance in an operating room was tested using a virtual reality simulator with cognitive load applied through two-digit math multiplication questions.
METHOD
11 subjects were randomized to Control, VR and VR + CL groups. After a pre-test, VR and VR + CL groups repeated the peg transfer task 150 times over 15 sessions with cognitive load applied only for the last 100 trials. After training, all groups took a post-test and two weeks later the retention test with and without cognitive load and the transfer task on a pig intestine of 150 cm long under cognitive load.
RESULTS AND CONCLUSION
Mixed ANOVA analysis showed significant differences between the control and VR and VR + CL groups (p = 0.013, p = 0.009) but no differences between the VR + CL and the VR groups (p = 1.0). GOALS bimanual dexterity score on transfer test show that VR + CL group outperformed both Control and VR groups (p = 0.016, p = 0.03). Training under cognitive load benefitted performance on an actual surgical task under similar conditions.",2020,"GOALS bimanual dexterity score on transfer test show that VR + CL group outperformed both Control and VR groups (p = 0.016, p = 0.03).",['11 subjects'],"['Control, VR and VR\xa0+\xa0CL', 'retention test with and without cognitive load and the transfer task on a pig intestine of 150\xa0cm long under cognitive load', 'VR\xa0+\xa0CL']",[],[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0039005', 'cui_str': 'Pigs'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",[],11.0,0.0101945,"GOALS bimanual dexterity score on transfer test show that VR + CL group outperformed both Control and VR groups (p = 0.016, p = 0.03).","[{'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Sankaranarayanan', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA. Electronic address: ganesh.sankaranarayanan@bswhealth.org.'}, {'ForeName': 'Coleman A', 'Initials': 'CA', 'LastName': 'Odlozil', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA.'}, {'ForeName': 'Katerina O', 'Initials': 'KO', 'LastName': 'Wells', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Leeds', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA.'}, {'ForeName': 'Sanket', 'Initials': 'S', 'LastName': 'Chauhan', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Fleshman', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Jones', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Suvranu', 'Initials': 'S', 'LastName': 'De', 'Affiliation': 'Center for Modeling, Simulation, and Imaging in Medicine, Rensselaer Polytechnic Institute, Troy, NY, USA.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.02.002']
861,32434470,"GlideScope® versus C-MAC®(D) videolaryngoscope versus Macintosh laryngoscope for double lumen endotracheal intubation in patients with predicted normal airways: a randomized, controlled, prospective trial.","BACKGROUND
The double lumen endotracheal tube (DLT) is the most widely-used device for single lung ventilation in current thoracic anesthesia practice. In recent years, the routine application of the videolaryngoscope for single lumen endotracheal intubation has increased; nevertheless there are few studies of the use of the videolaryngoscope for DLT. We wondered whether there were benefits to using the videolaryngoscope for DLT placement in patients with predicted normal airways. Therefore, this study was designed to compare the performances of the GlideScope®, the C-MAC®(D) videolaryngoscope and the Macintosh laryngoscope in DLT intubation.
METHODS
This was a randomized, controlled, prospective study. We randomly allocated 90 adult patients with predicted normal airways into three groups. All patients underwent routine anesthesia using different laryngoscopes according to group allocation. We compared DLT insertion times, first-pass success rates, numerical rating scales (NRS) of DLT delivery and DLT insertion, Cormack-Lehane degrees (C/L), hemodynamic changes and incidences of intubation complications. All outcomes were analyzed using SPSS13.0.
RESULTS
Compared with the GlideScope, the Macintosh gave shorter times for DLT insertion (median: 96 (IQR: 51 [min-max: 62-376] s vs 73 (26 [48-419] s, p = 0.003); however, there was no difference between the Macintosh and C-MAC(D) (p = 0.610). The Macintosh had a significantly higher successful first attempt rate than did the GlideScope or C-MAC(D) (p = 0.001, p = 0.028, respectively). NRS of DLT delivery and insertion were significantly lower in the Macintosh than in the others (p < 0.001). However, the C/L degree in the Macintosh was significantly higher than in the others (p < 0.001). The incidences of oral bleeding, hoarseness, sore throat and dental trauma were low in all groups (p > 0.05). There were no significant differences in DLT misplacement, fiberoptic time or hemodynamic changes among the groups.
CONCLUSIONS
Compared with the Macintosh laryngoscope, the GlideScope® and C-MAC®(D) videolaryngoscopes may not be recommended as the first choice for routine DLT intubation in patients with predicted normal airways.
TRIAL REGISTRATION
The study was prospectively registered at the Chinese Clinical Trial Registry (no. ChiCTR1900025718); principal investigator: Z.L.H.; date of registration: September 6, 2019.",2020,The Macintosh had a significantly higher successful first attempt rate than did the GlideScope or C-MAC(D),"['90 adult patients with predicted normal airways into three groups', 'patients with predicted normal airways']","['C-MAC®(D', 'routine anesthesia', 'GlideScope® versus C-MAC®(D) videolaryngoscope versus Macintosh laryngoscope', 'double lumen endotracheal tube (DLT']","['incidences of oral bleeding, hoarseness, sore throat and dental trauma', 'DLT misplacement, fiberoptic time or hemodynamic changes', 'DLT insertion times, first-pass success rates, numerical rating scales (NRS) of DLT delivery and DLT insertion, Cormack-Lehane degrees (C/L), hemodynamic changes and incidences of intubation complications', 'NRS of DLT delivery and insertion', 'successful first attempt rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0029163', 'cui_str': 'Bleeding from mouth'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C1301685', 'cui_str': 'Dental trauma'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0444693', 'cui_str': 'First pass'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1504364', 'cui_str': 'Intubation complication'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",90.0,0.0618911,The Macintosh had a significantly higher successful first attempt rate than did the GlideScope or C-MAC(D),"[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.'}, {'ForeName': 'Renlong', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.'}, {'ForeName': 'Zhixing', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Hang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.'}, {'ForeName': 'Shanjuan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China. Shanjuanwang@shsmu.edu.cn.'}, {'ForeName': 'Zhenling', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China. Zhenlinghuang@shsmu.edu.cn.'}]",BMC anesthesiology,['10.1186/s12871-020-01012-y']
862,32429839,Sevoflurane versus PRopofol combined with Remifentanil anesthesia Impact on postoperative Neurologic function in supratentorial Gliomas (SPRING): protocol for a randomized controlled trial.,"BACKGROUND
Patients with intracranial tumors are more sensitive to anesthetics than the general population and are therefore more susceptible to postoperative neurologic and neurocognitive dysfunction. Sevoflurane or propofol combined with remifentanil are widely used general anesthetic regimens for craniotomy, with neither regimen shown to be superior to the other in terms of neuroprotective efficacy and anesthesia quality. There is no evidence regarding the variable effects on postoperative neurologic and neurocognitive functional outcome under these two general anesthetic regimens. This trial will compare inhalational sevoflurane or intravenous propofol combined with remifentanil anesthesia in patients with supratentorial gliomas and test the hypothesis that postoperative neurologic function is equally affected between the two regimens.
METHODS
This is a prospective, single-center, randomized parallel arm equivalent clinical trial, which is approved by China Ethics Committee of Registering Clinical Trials (ChiECRCT-20,160,051). Patients with supratentorial gliomas diagnosed by magnetic resonance imaging will be eligible for the trial. Written informed consent will be obtained before randomly assigning each subject to either the sevoflurane-remifentanil or propofol-remifentanil group for anesthesia maintenance to achieve an equal-desired depth of anesthesia. Intraoperative intervention and monitoring will follow a standard anesthetic management protocol. All of the physiological parameters and other medications administered during the intervention will be recorded. The primary outcome will be neurologic function change assessed by National Institute of Health Stroke Scale (NIHSS) within 4 h after general anesthesia when observer's assessment of alertness/sedation (OAA/S) reaches 4. Secondary outcomes will include NIHSS and modified NIHSS change 1 and 2 days after general anesthesia, hemodynamic stability, intraoperative brain relaxation, quality of anesthesia emergence, quality of anesthesia recovery, postoperative cognitive function, postoperative pain, postoperative neurologic complications, as well as perioperative medical expense.
DISCUSSION
This randomized equivalency trial will primarily compare the impacts of sevoflurane-remifentanil and propofol-remifentanil anesthesia on short-term postoperative neurologic function in patients with supratentorial gliomas undergoing craniotomy. The exclusion criteria are strict to ensure that the groups are comparable in all aspects. Repeated and routine neurologic evaluations after operation are always important to evaluate neurosurgical patients' recovery and any newly presenting complications. The results of this trial would help specifically to interpret anesthetic residual effects on postoperative outcomes, and perhaps would help the anesthesiologist to select the optimal anesthetic regimen to minimize its impact on neurologic function in this specific patient population.
TRIAL REGISTRATION
The study was registered and approved by the Chinese Clinical Trial Registry (Chinese Clinical Trial Registry, ChiCTR-IOR-16009177). Principle investigator: Nan Lin (email address: linnan127@gmail.com) and Ruquan Han (email address: hanrq666@aliyun.com) Date of Registration: September 8th, 2016. Country of recruitment: China.",2020,The primary outcome will be neurologic function change assessed by National Institute of Health Stroke Scale (NIHSS) within 4 h after general anesthesia when observer's assessment of alertness/sedation (OAA/S) reaches 4.,"['patients with supratentorial gliomas', 'patients with supratentorial gliomas undergoing craniotomy', 'supratentorial Gliomas (SPRING', 'Patients with supratentorial gliomas diagnosed by', 'Patients with intracranial tumors']","['Intraoperative intervention', 'propofol combined with remifentanil anesthesia', 'hanrq666@aliyun.com', 'Sevoflurane', 'inhalational sevoflurane', 'Remifentanil anesthesia', 'sevoflurane-remifentanil or propofol-remifentanil', 'magnetic resonance imaging', 'sevoflurane-remifentanil and propofol-remifentanil anesthesia', 'Lin (email address: linnan127@gmail.com) and Ruquan Han (email address', 'PRopofol', 'Sevoflurane or propofol combined with remifentanil']","['postoperative Neurologic function', ""neurologic function change assessed by National Institute of Health Stroke Scale (NIHSS) within 4\u2009h after general anesthesia when observer's assessment of alertness/sedation (OAA/S) reaches 4"", 'postoperative neurologic function', 'postoperative neurologic and neurocognitive functional outcome', 'NIHSS and modified NIHSS change 1 and 2 days after general anesthesia, hemodynamic stability, intraoperative brain relaxation, quality of anesthesia emergence, quality of anesthesia recovery, postoperative cognitive function, postoperative pain, postoperative neurologic complications, as well as perioperative medical expense']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1527390', 'cui_str': 'Intracranial tumor'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0574448', 'cui_str': 'Lingala language'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0641339', 'cui_str': 'hexaaquanickel(II) chlorate'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]",,0.123406,The primary outcome will be neurologic function change assessed by National Institute of Health Stroke Scale (NIHSS) within 4 h after general anesthesia when observer's assessment of alertness/sedation (OAA/S) reaches 4.,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China. linnan127@gmail.com.'}, {'ForeName': 'Ruquan', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China. Hanrq666@aliyun.com.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Bebawy', 'Affiliation': 'Departments of Anesthesiology & Neurological Surgery, Northwestern University Feinberg School of Medicine, 251 E. Huron St., F5-704, Chicago, IL, 60611, USA.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Xiaoyuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Manyu', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Lanyi', 'Initials': 'L', 'LastName': 'Nie', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01035-5']
863,32434495,Effect of sevoflurane and propofol on tourniquet-induced endothelial damage: a pilot randomized controlled trial for knee-ligament surgery.,"BACKGROUND
The glycocalyx layer is a key structure in the endothelium. Tourniquet-induced ischemic periods are used during orthopedic surgery, and the reactive oxygen species generated after ischemia-reperfusion may mediate the shedding of the glycocalyx. Here, we describe the effects of tourniquet-induced ischemia-reperfusion and compare the effects of sevoflurane and propofol on the release of endothelial biomarkers after ischemia-reperfusion in knee-ligament surgery.
METHODS
This pilot, single-center, blinded, randomized, controlled trial included 16 healthy patients. After spinal anesthesia, hypnosis was achieved with sevoflurane or propofol according to randomization. During the perioperative period, five venous blood samples were collected for quantification of syndecan-1, heparan sulfate, and thrombomodulin from blood serum by using ELISA assays kits. Sample size calculation was performed to detect a 25% change in the mean concentration of syndecan-1 with an alpha of 0.05 and power of 80%.
RESULTS
For our primary outcome, a two-way ANOVA with post-hoc Bonferroni correction analysis showed no differences in syndecan-1 concentrations between the sevoflurane and propofol groups at any time point. In the sevoflurane group, we noted an increase in syndecan-1 concentrations 90 min after tourniquet release in the sevoflurane group from 34.6 ± 24.4 ng/mL to 47.9 ± 29.8 ng/mL (Wilcoxon test, p < 0.01) that was not observed in patients randomized to the propofol group. The two-way ANOVA showed no intergroup differences in heparan sulfate and thrombomodulin levels.
CONCLUSIONS
Superficial endothelial damage without alterations in the cell layer integrity was observed after tourniquet knee-ligament surgery. There was no elevation in serum endothelial biomarkers in the propofol group patients. Sevoflurane did not show the protective effect observed in in vitro and in vivo studies.
TRIAL REGISTRATION
The trial was registered in www.clinicaltrials.gov (ref: NCT03772054, Registered 11 December 2018).",2020,"In the sevoflurane group, we noted an increase in syndecan-1 concentrations 90 min after tourniquet release in the sevoflurane group from 34.6 ± 24.4 ng/mL to 47.9 ± 29.8 ng/mL (Wilcoxon test, p < 0.01) that was not observed in patients randomized to the propofol group.","['16 healthy patients', 'knee-ligament surgery']","['sevoflurane and propofol', 'tourniquet-induced ischemia-reperfusion', 'sevoflurane', 'propofol', 'sevoflurane or propofol', 'Sevoflurane']","['syndecan-1 concentrations 90\u2009min after tourniquet release', 'endothelial biomarkers', 'cell layer integrity', 'syndecan-1 concentrations', 'serum endothelial biomarkers', 'heparan sulfate and thrombomodulin levels', 'tourniquet-induced endothelial damage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0412803', 'cui_str': 'Tourniquet release'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019143', 'cui_str': 'Heparan sulfate'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010957', 'cui_str': 'Damage'}]",16.0,0.215818,"In the sevoflurane group, we noted an increase in syndecan-1 concentrations 90 min after tourniquet release in the sevoflurane group from 34.6 ± 24.4 ng/mL to 47.9 ± 29.8 ng/mL (Wilcoxon test, p < 0.01) that was not observed in patients randomized to the propofol group.","[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Maldonado', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine. Hospital Clínico de la Universidad de Chile. Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Morales', 'Affiliation': 'Program of Cellular and Molecular Biology, Institute of Biomedical Sciences (ICBM), Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Gutiérrez', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine. Hospital Clínico de la Universidad de Chile. Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Maximiliano', 'Initials': 'M', 'LastName': 'Barahona', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Cerda', 'Affiliation': 'Program of Cellular and Molecular Biology, Institute of Biomedical Sciences (ICBM), Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Cáceres', 'Affiliation': 'Program of Cellular and Molecular Biology, Institute of Biomedical Sciences (ICBM), Faculty of Medicine, Universidad de Chile, Santiago, Chile. monicacaceres@med.uchile.cl.'}]",BMC anesthesiology,['10.1186/s12871-020-01030-w']
864,32434884,HIV RNA Rebound in Seminal Plasma after Antiretroviral Treatment Interruption.,"If strategies currently in development succeed in eradicating HIV reservoirs in peripheral blood and lymphoid tissues, residual sources of virus may remain in anatomic compartments. Paired blood and semen samples were collected from 12 individuals enrolled in a randomized, double-blind, placebo-controlled therapeutic vaccine clinical trial in people with HIV (PWH) who began antiretroviral therapy (ART) during acute or early infection (ClinicalTrials registration no. NCT01859325). After the week 56 visit (postintervention), all participants interrupted ART. At the first available time points after viral rebound, we sequenced HIV-1 env (C2-V3), gag (p24), and pol (reverse transcriptase) regions amplified from cell-free HIV RNA in blood and seminal plasma using the MiSeq Illumina platform. Comprehensive sequence and phylogenetic analyses were performed to evaluate viral population structure, compartmentalization, and viral diversity in blood and seminal plasma. Compared to that in blood, HIV RNA rebound in semen occurred significantly later (median of 66 versus 42 days post-ART interruption, P < 0.01) and reached lower levels (median 164 versus 16,090 copies/ml, P < 0.01). Three of five participants with available sequencing data presented compartmentalized viral rebound between blood and semen in one HIV coding region. Despite early ART initiation, HIV RNA molecular diversity was higher in semen than in blood in all three coding regions for most participants. Higher HIV RNA molecular diversity in the genital tract (compared to that in blood plasma) and evidence of compartmentalization illustrate the distinct evolutionary dynamics between these two compartments after ART interruption. Future research should evaluate whether the genital compartment might contribute to viral rebound in some PWH interrupting ART. IMPORTANCE To cure HIV, we likely need to target the reservoirs in all anatomic compartments. Here, we used sophisticated statistical and phylogenetic methods to analyze blood and semen samples collected from 12 persons with HIV who began antiretroviral therapy (ART) during very early HIV infection and who interrupted their ART as part of a clinical trial. First, we found that HIV RNA rebound in semen occurred significantly later and reached lower levels than in blood. Second, we found that the virus in semen was genetically different in some participants compared to that in blood. Finally, we found increased HIV RNA molecular diversity in semen compared to that in blood in almost all study participants. These data suggest that the HIV RNA populations emerging from the genital compartment after ART interruption might not be the same as those emerging from blood plasma. Future research should evaluate whether the genital compartment might contribute to viral rebound in some people with HIV (PWH) interrupting ART.",2020,"Despite early ART initiation, HIV RNA molecular diversity was higher in semen compared to blood in all three coding regions for most participants.","['clinical trial in people with HIV (PWH) who began ART during acute or early infection (NCT01859325', '12 individuals enrolled', '12 persons with HIV who began antiretroviral therapy (ART) during very early HIV-infection and who interrupted their ART as part of a clinical trial']","['placebo-controlled therapeutic vaccine', 'antiretroviral therapy (ART']","['sequenced HIV-1 env ( C2-V3 ), gag (p24), and pol ( reverse transcriptase) regions amplified from cell-free HIV RNA in blood and seminal plasma', 'viral population structure, compartmentalization and viral diversity in blood and seminal plasma', 'HIV RNA rebound in semen', 'blood, HIV RNA rebound in semen', 'HIV RNA molecular diversity']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042210', 'cui_str': 'Vaccine'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0017343', 'cui_str': 'ENV gene'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0035379', 'cui_str': 'RNA-directed DNA polymerase'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0242499', 'cui_str': 'Seminal plasma'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0877595', 'cui_str': 'HIV RNA rebound'}]",5.0,0.115519,"Despite early ART initiation, HIV RNA molecular diversity was higher in semen compared to blood in all three coding regions for most participants.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gianella', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA gianella@ucsd.edu.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Chaillon', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Tae-Wook', 'Initials': 'TW', 'LastName': 'Chun', 'Affiliation': 'National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Maryland, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Sneller', 'Affiliation': 'National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Maryland, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ignacio', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Milenka V', 'Initials': 'MV', 'LastName': 'Vargas-Meneses', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Caballero', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Ellis', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Kovacs', 'Affiliation': 'Maple Leaf Medical Clinic, Toronto, Ontario, Canada.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Benko', 'Affiliation': 'Maple Leaf Medical Clinic, Toronto, Ontario, Canada.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Huibner', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Kaul', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}]",Journal of virology,['10.1128/JVI.00415-20']
865,31834099,"No Influence of Low-, Medium-, or High-Dose Tyrosine on Exercise in a Warm Environment.","PURPOSE
Tyrosine administration may counter exercise fatigue in a warm environment, but the typical dose is inconclusive, with little known about higher doses. We explored how three tyrosine doses influenced the circulating ratio of tyrosine/amino acids competing for brain uptake and hypothesized that a medium and high dose would enhance exercise performance in a warm environment.
METHODS
Eight recreationally trained, non-heat-acclimated male individuals (mean ± SD age, 23 ± 4 yr; stature, 181 ± 7 cm; body mass, 76.1 ± 5.9 kg; peak oxygen uptake, 4.1 ± 0.5 L·min) performed a peak oxygen uptake test, two familiarization trials, then four experimental trials in a randomized order separated by 7 d. Before exercise, subjects drank 2 × 300 mL sugar-free drinks delivering 0 (PLA), 150 (LOW), 300 (MED), or 400 (HIGH) mg·kg body mass tyrosine in a double-blind fashion. Subjects performed a 60-min constant intensity cycling then a simulated time trial in 30°C and 60% relative humidity.
RESULTS
Time trial performance (P = 0.579) was not influenced by tyrosine ingestion. The plasma ratio of tyrosine/∑(free-tryptophan, leucine, isoleucine, valine, phenylalanine, methionine), a key determinant of brain tyrosine influx, increased relative to PLA (P < 0.001). The increase was similar (P > 0.05) in MED (7.7-fold) and HIGH (8.2-fold), and greater than that in LOW (5.3-fold; P < 0.05). No differences existed between trials in core and skin temperature, heart rate, RPE, or thermal sensation (P > 0.05).
CONCLUSION
Exercise performance in a warm environment was not influenced by tyrosine availability in recreationally trained male individuals. The results provide novel data informing future studies, on the tyrosine dose maximizing the circulating ratio of tyrosine/amino acids competing for brain uptake.",2020,"No differences existed between trials in core and skin temperature, heart rate, RPE, or thermal sensation (P > 0.05).
","['recreationally trained male individuals', 'Eight recreationally trained, non-heat-acclimated male individuals (mean ± SD age, 23 ± 4 yr; stature, 181 ± 7 cm; body mass, 76.1 ± 5.9 kg; peak oxygen uptake, 4.1 ± 0.5 L·min) performed a peak oxygen uptake test, two familiarization trials']","['Low-, Medium-, or High-Dose Tyrosine', 'subjects drank 2 × 300 mL sugar-free drinks delivering 0 (PLA), 150 (LOW), 300 (MED), or 400 (HIGH) mg·kg body mass tyrosine in a double-blind fashion']","['core and skin temperature, heart rate, RPE, or thermal sensation', 'plasma ratio of tyrosine/∑(free-tryptophan, leucine, isoleucine, valine, phenylalanine, methionine), a key determinant of brain tyrosine influx']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0022192', 'cui_str': 'Isoleucine'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}]",8.0,0.149914,"No differences existed between trials in core and skin temperature, heart rate, RPE, or thermal sensation (P > 0.05).
","[{'ForeName': 'Les', 'Initials': 'L', 'LastName': 'Tumilty', 'Affiliation': 'Institute of Biological, Environmental and Rural Sciences, Aberystwyth University, Wales, UNITED KINGDOM.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Gregory', 'Affiliation': ''}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Beckmann', 'Affiliation': ''}, {'ForeName': 'Rhys', 'Initials': 'R', 'LastName': 'Thatcher', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002245']
866,32077140,The effects of meclizine on motion sickness revisited.,"AIMS
Antihistamines make up the first line of treatments against motion-sickness. Still, their efficacy and specific mechanism have come into question. The aim of this study was to investigate the effect of meclizine on motion-sensitivity.
METHODS
This study was carried out as a triple-blinded randomized trial involving 12 healthy subjects who were exposed to (i) vestibular (VES), (ii) visual (VIS) and (iii) visual-vestibular (VIS+VES) stimulations in the roll plane. Subjects were divided into 2 groups by stratified randomization, receiving either meclizine or a placebo. Stimulations were carried out before, and after, drug administration, presented at 2 intensity levels of 14 and 28°/s 2 . Eye movements were tracked, and torsional slow-phase velocities, amplitudes and nystagmus beats were retrieved. Subjects initially graded for their motion-sickness susceptibility.
RESULTS
Susceptibility had no effect on intervention outcome. Despite large variations, repeated ANOVAS showed that meclizine led to a relative increase in torsional velocity compared to placebo during vestibular stimulation for both intensities: 2.36 (7.65) from -0.01 (4.17) during low intensities, and 2.61 (6.67) from -3.49 (4.76) during high. The visual-vestibular stimuli yielded a decrease during low acceleration, -0.40 (3.87) from 3.75 (5.62), but increased during high, 3.88 (6.51) from -3.88 (8.55).
CONCLUSIONS
Meclizine had an inhibitory effect on eye movement reflexes for low accelerations during VIS+VES trials. This indicates that meclizine may not primarily work through sensory-specific mechanisms, but rather on a more central level. Practically, meclizine shows promise in targeting motion-sickness evoked by everyday activities, but its use may be counterproductive in high-acceleration environments.",2020,"CONCLUSIONS
Meclizine had an inhibitory effect on eye movement reflexes for low accelerations during VIS+VES trials.","['12 healthy subjects who were exposed to i) vestibular (VES), ii) visual (VIS), and iii) visual-vestibular (VIS+VES) stimulations in the roll plane', 'Subjects initially graded their motion-sickness susceptibility']","['placebo', 'Meclizine or a placebo', 'Meclizine']","['eye movement reflexes', 'torsional slow-phase velocities, amplitudes and nystagmus beats', 'torsional velocity', 'motion-sensitivity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0026603', 'cui_str': 'Motion Sickness'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025039', 'cui_str': 'meclozine'}]","[{'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0450425', 'cui_str': 'Torsional (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus, Pathologic'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",12.0,0.132329,"CONCLUSIONS
Meclizine had an inhibitory effect on eye movement reflexes for low accelerations during VIS+VES trials.","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Wibble', 'Affiliation': 'Department of Clinical Neuroscience, Division of Ophthalmology and Vision, Marianne Bernadotte Centre, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Engström', 'Affiliation': 'Department of Clinical Neuroscience, Division of Ophthalmology and Vision, Marianne Bernadotte Centre, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Verrecchia', 'Affiliation': 'Department of Clinical Neuroscience, Division of Ophthalmology and Vision, Marianne Bernadotte Centre, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Pansell', 'Affiliation': 'Department of Clinical Neuroscience, Division of Ophthalmology and Vision, Marianne Bernadotte Centre, Karolinska Institutet, Stockholm, Sweden.'}]",British journal of clinical pharmacology,['10.1111/bcp.14257']
867,32493267,Effectiveness of a progressive resistance exercise program for industrial workers during breaks on perceived fatigue control: a cluster randomized controlled trial.,"BACKGROUND
There is strong evidence that physical exercise in the workplace is effective for reducing workers' musculoskeletal complaints. Studies with industrial workers and studies on progressive resistance exercises during breaks are scarce. Our aim was to evaluate the effects of a resistance exercise program on perceived fatigue control among industrial workers.
METHODS
204 employees from the dairy industry were allocated to two groups, the intervention group (IG) (n = 98) and the control group (CG) (n = 106). The primary outcome measures were perceived fatigue control and maximum muscle strength, measured through the Need for Recovery Scale and one-repetition maximum contraction (1-RM), respectively. Secondary outcome measures were musculoskeletal complaints, physical activity level, perceived risk factors, physical fitness (BMI, vital signs, and body fat percentage), and workers´ productivity. All outcomes were assessed at baseline and then again after 4 months. The IG performed resistance exercises using progressively greater loads while the CG performed general exercise using elastic bands. The exercise protocols were performed three times per week for 20 min. An intention-to-treat analysis was performed using the mixed linear model. Results were considered significant when p < 0.05.
RESULTS
The IG did not show to be superior to the CG, although both groups improved perceived fatigue control and muscle strength after the resistance physical exercise program in the worplace. There was also no significant difference between the groups for musculoskeletal complaints and other secondary variables analyzed. However, both groups showed significant improvements between baseline and after 4 months of intervention for all evaluated outcomes (p < 0.05).
CONCLUSION
The implementation of a progressive resistance exercise program during work breaks for perceived fatigue control was no more effective than exercises using elastic bands. However, resistance exercises during work breaks presented better results on all measured outcomes regardless of the exercise protocol used.
TRIAL REGISTRATION
U.S. National Institutes of Health, ClinicalTrials.gov Identifier: NCT02172053. Registered 19 June 2014.",2020,"The IG did not show to be superior to the CG, although both groups improved perceived fatigue control and muscle strength after the resistance physical exercise program in the worplace.","[""workers' musculoskeletal complaints"", 'industrial workers during breaks on perceived fatigue control', 'industrial workers', '204 employees from the dairy industry']","['control group (CG', 'resistance exercise program', 'progressive resistance exercise program', 'physical exercise']","['fatigue control and maximum muscle strength, measured through the Need for Recovery Scale and one-repetition maximum contraction (1-RM', 'musculoskeletal complaints', 'fatigue control and muscle strength', 'progressive resistance exercises', 'musculoskeletal complaints, physical activity level, perceived risk factors, physical fitness (BMI, vital signs, and body fat percentage), and workers´ productivity']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C4279966', 'cui_str': 'Dairy Industry'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",204.0,0.0894599,"The IG did not show to be superior to the CG, although both groups improved perceived fatigue control and muscle strength after the resistance physical exercise program in the worplace.","[{'ForeName': 'Hélio Gustavo', 'Initials': 'HG', 'LastName': 'Santos', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), Rua Cesário Galeno, 448/475 Tatuapé, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Luciana Dias', 'Initials': 'LD', 'LastName': 'Chiavegato', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), Rua Cesário Galeno, 448/475 Tatuapé, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Daniela Pereira', 'Initials': 'DP', 'LastName': 'Valentim', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), Rua Cesário Galeno, 448/475 Tatuapé, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Rosimeire Simprini', 'Initials': 'RS', 'LastName': 'Padula', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), Rua Cesário Galeno, 448/475 Tatuapé, São Paulo, 03071-000, Brazil. rosimeire.padula@unicid.edu.br.'}]",BMC public health,['10.1186/s12889-020-08994-x']
868,31883336,Pilot Randomized Controlled Trial of Web-Delivered Acceptance and Commitment Therapy Versus Smokefree.gov for Smokers With Bipolar Disorder.,"INTRODUCTION
Smokers with bipolar disorder (BD) are less successful at quitting than the general population. In this study, we evaluated in a pilot randomized controlled trial a novel, targeted, web-based intervention for smokers with BD based on acceptance and commitment therapy (ACT) and designed for reach and disseminability.
AIMS AND METHODS
Daily smokers (n = 51) with bipolar I or II disorder were recruited from four US sites and randomly assigned to one of two web-based smoking cessation interventions-ACT-based WebQuit Plus (n = 25) or Smokefree.gov (n = 26) over a 10-week treatment period. All participants received nicotine patch for 8 weeks. Key outcomes were trial design feasibility, intervention acceptability, and cessation at end of treatment and 1-month follow-up.
RESULTS
We screened 119 to enroll 51 participants (target sample size = 60) over 24 months. The most common reason for ineligibility was the inability to attend study appointments. Retention was 73% at end of treatment and 80% at follow-up, with no differences by arm. The mean number of logins was twice as high for WebQuit Plus (10.3 vs. 5.3). The usefulness of program skills was rated higher for WebQuit Plus (75% vs. 29%). Biochemically confirmed, 7-day abstinence at end of treatment was 12% in WebQuit Plus versus 8% in Smokefree.gov (odds ratio = 1.46, 95% confidence interval = 0.21 to 9.97). At follow-up, abstinence rates were 8% in both arms.
CONCLUSIONS
Trial design produced favorable retention rates, although alternative recruitment methods will be needed for a larger trial. At end of treatment, acceptability and estimated effect size of WebQuit Plus relative to Smokefree.gov were promising and support continued program refinement and evaluation.
IMPLICATIONS
In this first randomized controlled trial of a targeted intervention for smokers with BD, we found that the ACT-based WebQuit Plus intervention, delivered in combination with the nicotine patch, had promising acceptability and cessation outcomes relative to Smokefree.gov. The observed signals for acceptability and cessation suggest that the WebQuit Plus program should be refined based on participant feedback and evaluated in a larger trial. Feasibility findings from this study also provide direction for refining trial procedures to enhance the recruitment of smokers with BD.",2020,Usefulness of program skills was rated higher for WebQuit,"['Smokers With Bipolar Disorder', 'smokers with BD based on acceptance and commitment therapy (ACT) and designed for reach and disseminability', 'We screened 119 to enroll 51 participants (target sample size=60) over 24 months', 'smokers with bipolar disorder', 'Smokers with bipolar disorder (BD', 'Daily smokers (n=51) with bipolar I or II disorder']","['nicotine patch', 'ACT-based WebQuit Plus intervention, delivered in combination with nicotine patch', 'Web-Delivered Acceptance and Commitment Therapy Versus Smokefree.gov', 'smoking cessation interventions-ACT-based WebQuit Plus (n=25) or Smokefree.gov']","['feasibility, intervention acceptability, and cessation at end-of-treatment and 1-month follow-up', 'acceptability and estimated effect size of WebQuit', 'abstinence rates', 'Retention', 'Mean number of logins']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",51.0,0.223883,Usefulness of program skills was rated higher for WebQuit,"[{'ForeName': 'Jaimee L', 'Initials': 'JL', 'LastName': 'Heffner', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Kelly', 'Affiliation': 'Edith Nourse Rogers Memorial VA Medical Center, Bedford, MA.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Waxmonsky', 'Affiliation': 'Department of Family Medicine, University of Colorado Anschutz Medical Center, Aurora, CO.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mattocks', 'Affiliation': 'VA Central Western Massachusetts Healthcare System, Leeds, MA.'}, {'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Serfozo', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Bricker', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Mull', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Noreen L', 'Initials': 'NL', 'LastName': 'Watson', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ostacher', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz242']
869,32493276,The effect of intraoperative lidocaine infusion on opioid consumption and pain after totally extraperitoneal laparoscopic inguinal hernioplasty: a randomized controlled trial.,"BACKGROUND
As a component of multimodal analgesia, the administration of systemic lidocaine is a well-known technique. We aimed to evaluate the efficacy of lidocaine infusion on postoperative pain-related outcomes in patients undergoing totally extraperitoneal (TEP) laparoscopies inguinal hernioplasty.
METHODS
In this randomized controlled double-blind study, we recruited 64 patients to receive either lidocaine 2% (intravenous bolus 1.5 mg. kg - 1 followed by an infusion of 2 mg. kg - 1 . h - 1 ), or an equal volume of normal saline. The infusion was initiated just before the induction of anesthesia and discontinued after tracheal extubation. The primary outcome of the study was postoperative morphine equivalent consumption up to 24 h after surgery. Secondary outcomes included postoperative pain scores, nausea/vomiting (PONV), sedation, quality of recovery (scores based on QoR-40 questionnaire), patient satisfaction, and the incidence of chronic pain.
RESULTS
The median (IQR) cumulative postoperative morphine equivalent consumption in the first 24 h was 0 (0-1) mg in the lidocaine group and 4 [1-8] mg in the saline group (p < 0.001). Postoperative pain intensity at rest and during movement at various time points in the first 24 h were significantly lower in the lidocaine group compared with the saline group (p < 0.05). Fewer patients reported PONV in the lidocaine group than in the saline group (p < 0.05). Median QoR scores at 24 h after surgery were significantly better in the lidocaine group (194 (194-196) than saline group 184 (183-186) (p < 0.001). Patients receiving lidocaine were more satisfied with postoperative analgesia than those receiving saline (p = 0.02). No difference was detected in terms of postoperative sedation and chronic pain after surgery.
CONCLUSIONS
Intraoperative lidocaine infusion for laparoscopic TEP inguinal hernioplasty reduces opioid consumption, pain intensity, PONV and improves the quality of recovery and patient satisfaction.
TRIAL REGISTRATION
ClinicalTrials.gov- NCT02601651. Date of registration: November 10, 2015.",2020,Median QoR scores at 24 h after surgery were significantly better in the lidocaine group (194 (194-196) than saline group 184 (183-186) (p < 0.001).,"['patients undergoing totally extraperitoneal (TEP) laparoscopies inguinal hernioplasty', '64 patients to receive either', 'after totally extraperitoneal laparoscopic inguinal hernioplasty']","['lidocaine infusion', 'lidocaine', 'intraoperative lidocaine infusion', 'lidocaine 2% (intravenous bolus 1.5\u2009mg']","['postoperative morphine equivalent consumption', 'satisfied with postoperative analgesia', 'postoperative pain scores, nausea/vomiting (PONV), sedation, quality of recovery (scores based on QoR-40 questionnaire), patient satisfaction, and the incidence of chronic pain', 'median (IQR) cumulative postoperative morphine', 'postoperative pain-related outcomes', 'PONV', 'opioid consumption, pain intensity, PONV and improves the quality of recovery and patient satisfaction', 'Median QoR scores', 'opioid consumption and pain', 'Postoperative pain intensity', 'equivalent consumption', 'postoperative sedation and chronic pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4284593', 'cui_str': 'Inguinal hernioplasty'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.699271,Median QoR scores at 24 h after surgery were significantly better in the lidocaine group (194 (194-196) than saline group 184 (183-186) (p < 0.001).,"[{'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Ghimire', 'Affiliation': 'Department of Anesthesiology, Nepal Mediciti Hospital, Lalitpur, Nepal.'}, {'ForeName': 'Asish', 'Initials': 'A', 'LastName': 'Subedi', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, BP Koirala Institute of Health Sciences, Dharan, Nepal. asishsubedi19@gmail.com.'}, {'ForeName': 'Balkrishna', 'Initials': 'B', 'LastName': 'Bhattarai', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, BP Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Birendra Prasad', 'Initials': 'BP', 'LastName': 'Sah', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, BP Koirala Institute of Health Sciences, Dharan, Nepal.'}]",BMC anesthesiology,['10.1186/s12871-020-01054-2']
870,32127350,Impact of Social Support on Colorectal Cancer Screening among Adult Hispanics/Latinos: A Randomized Community-based Study in Central Pennsylvania.,"In the United States, the five-year survival rate of colorectal cancer for Latinos is lower than it is for White, non-Latinos. Differences in survival are due, in part, to Latinos being diagnosed at a later stage. An ethnic gap in the use of colorectal cancer screening contributes to the difference in survival. We developed, implemented, and evaluated a targeted colorectal cancer screening intervention to increase colorectal cancer screening uptake by sex, ethnicity, and geography. We measured actual colorectal cancer screening uptake in both arms as a method to determine completion rates. We used a randomized, community-based, participatory design to test the impact of social support (intervention) on completion of a provider-recommended, take-home fecal immunochemical test (FIT) kit screening test among average-risk, urban, and rural Pennsylvania Latino adults age 50 and older not currently adherent to national colorectal cancer screening guidelines ( n = 264). Participants in each arm attended a community-based educational program offered at eight sites. Among the 264 participants, 154 (58%) returned a completed usable FIT kit screening test. A higher return rate was observed among participants in the social support arm (66.0%) compared with the control (47.2%). Participants in the social support arm were statistically significant 2.67 times as likely to return a completed FIT kit. Of these, 27 (17.5%) had a positive FIT kit screening test result. The results of this study suggest that social support is an effective method to increase colorectal cancer screening rates among Latinos. Future studies should examine dissemination and implementation of community-based strategies among Latinos that include social support.",2020,A higher return rate was observed among participants in the social support arm (66.0%) compared to the control (47.2%).,"['average-risk, urban and rural Pennsylvania Latino adults age 50 and older not currently adherent to national CRC screening guidelines (n=264', '264 participants, 154 (58%) returned a completed usable FIT kit screening test', 'Latinos', 'Adult Hispanics']","['social support (intervention', 'Social Support', 'CRC screening intervention', 'provider-recommended, take-home fecal immunochemical test (FIT) kit screening test']","['survival', 'CRC screening rates', 'return rate', 'actual CRC screening uptake']","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}]","[{'cui': 'C0037438'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",264.0,0.0226142,A higher return rate was observed among participants in the social support arm (66.0%) compared to the control (47.2%).,"[{'ForeName': 'Oralia G', 'Initials': 'OG', 'LastName': 'Dominic', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania. Dr.Oralia@gmail.com.'}, {'ForeName': 'Vern', 'Initials': 'V', 'LastName': 'Chinchilli', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Wasserman', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Curry', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Kambic', 'Affiliation': 'Kambic Family Clinic, Steelton, Pennsylvania.'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Caicedo', 'Affiliation': 'Pinnacle Health System, Harrisburg, Pennsylvania.'}, {'ForeName': 'Amelie G', 'Initials': 'AG', 'LastName': 'Ramirez', 'Affiliation': 'Institute for Health Promotion Research, Health Disparities Research, UT Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ochoa', 'Affiliation': 'Department of Spanish, Italian and Portuguese, College of Health and Human Development, The Pennsylvania State University, State College, Pennsylvania.'}, {'ForeName': 'Eugene J', 'Initials': 'EJ', 'LastName': 'Lengerich', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0333']
871,30189000,Engaging hospital patients in the medication reconciliation process using tablet computers.,"Objective
Unintentional medication discrepancies contribute to preventable adverse drug events in patients. Patient engagement in medication safety beyond verbal participation in medication reconciliation is limited. We conducted a pilot study to determine whether patients' use of an electronic home medication review tool could improve medication safety during hospitalization.
Materials and Methods
Patients were randomized to use a tool before or after hospital admission medication reconciliation to review and modify their home medication list. We assessed the quantity, potential severity, and potential harm of patients' and clinicians' medication changes. We also surveyed clinicians to assess the tool's usefulness.
Results
Of 76 patients approached, 65 (86%) participated. Forty-eight (74%) made changes to their home medication list [before: 29 (81%), after: 19 (66%), p = .170]. Before group participants identified 57 changes that clinicians subsequently missed on admission medication reconciliation. Thirty-nine (74%) had a significant or greater potential severity, and 19 (36%) had a greater than 50-50 chance of harm. After group patients identified 68 additional changes to their reconciled medication lists. Fifty-one (75%) had a significant or greater potential severity, and 33 (49%) had a greater than 50-50 chance of harm. Clinicians reported believing that the tool would save time, and patients would supply useful information.
Discussion
The results demonstrate a high willingness of patients to engage in medication reconciliation, and show that patients were able to identify important medication discrepancies and often changes that clinicians missed.
Conclusion
Engaging patients in admission medication reconciliation using an electronic home medication review tool may improve medication safety during hospitalization.",2018,"The results demonstrate a high willingness of patients to engage in medication reconciliation, and show that patients were able to identify important medication discrepancies and often changes that clinicians missed.
","['76 patients approached, 65 (86%) participated', 'patients']",[],"['admission medication reconciliation', 'medication safety', 'potential severity', ""quantity, potential severity, and potential harm of patients' and clinicians' medication changes""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",[],"[{'cui': 'C2317067', 'cui_str': 'Medication Reconciliation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}]",76.0,0.0266847,"The results demonstrate a high willingness of patients to engage in medication reconciliation, and show that patients were able to identify important medication discrepancies and often changes that clinicians missed.
","[{'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Prey', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Polubriaginof', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}, {'ForeName': 'Lisa V', 'Initials': 'LV', 'LastName': 'Grossman', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Masterson Creber', 'Affiliation': 'School of Nursing, Columbia University, New York, New York, USA.'}, {'ForeName': 'Demetra', 'Initials': 'D', 'LastName': 'Tsapepas', 'Affiliation': 'Value Institute at NewYork-Presbyterian Hospital, New York, New York, USA.'}, {'ForeName': 'Rimma', 'Initials': 'R', 'LastName': 'Perotte', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Qian', 'Affiliation': 'Department of Biostatistics, Columbia University, New York, New York, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Restaino', 'Affiliation': 'Value Institute at NewYork-Presbyterian Hospital, New York, New York, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Bakken', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hripcsak', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Efird', 'Affiliation': 'Value Institute at NewYork-Presbyterian Hospital, New York, New York, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Underwood', 'Affiliation': 'Value Institute at NewYork-Presbyterian Hospital, New York, New York, USA.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Vawdrey', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocy115']
872,31515507,Impact of low-intensity resistance and whole-body vibration training on aortic hemodynamics and vascular function in postmenopausal women.,"To examine the effects of low-intensity resistance exercise training (LIRET) and whole-body vibration training (WBVT) with an external weighted vest on arterial stiffness, wave reflection, brachial flow-mediated dilation (FMD), and physical performance in postmenopausal women. Thirty-three postmenopausal women were stratified by age, body mass index (BMI), and maximal voluntary contraction (MVC) (age, 65 ± 4 years; BMI, 23.3 ± 2.6 kg/m 2 ; MVC, 17.4 ± 2.6 kg) and randomized into LIRET, WBVT, or a nonexercising control group for 12 weeks. Arterial stiffness, augmentation index (AIx), augmented pressure (AP), brachial FMD, gait speed and leg strength were measured at baseline and 12 weeks. WBVT induced improvements in pulse pressure amplification (PPA) (0.04 ± 0.02) compared to control (P = 0.048) and in wave reflection indices [AIx (-4.3 ± 1.4%) and AP (-2.9 ± 1.3 mmHg)] compared to LIRET (P = 0.039 and 0.048, respectively). WBVT (3.8 ± 1.4%) and LIRET (5.0 ± 1.5%) induced similar improvements in FMD compared to control (P = 0.029 and 0.008, respectively). WBVT and LIRET elicited similar increases in leg strength (P = 0.001 and 0.019, respectively), compared to no improvement in the control group. LIRET significantly increased gait speed compared to WBVT (P = 0.043). Although both WBVT and LIRET increased brachial artery FMD (systemic effect), WBVT seemed to be more efficacious in improving wave reflection and cardiac pulsatile load. Interestingly, LIRET elicited a significant improvement in gait speed. Both modalities seem effective in improving systemic endothelial function and muscle strength in postmenopausal women.",2019,"WBVT and LIRET elicited similar increases in leg strength (P = 0.001 and 0.019, respectively), compared to no improvement in the control group.","['Thirty-three postmenopausal women were stratified by age, body mass index (BMI), and maximal voluntary contraction (MVC) (age, 65\u2009±\u20094 years; BMI, 23.3\u2009±\u20092.6\u2009kg/m 2 ; MVC, 17.4\u2009±\u20092.6\u2009kg) and randomized into', 'postmenopausal women']","['WBVT and LIRET', 'LIRET, WBVT, or a nonexercising control', 'WBVT', 'low-intensity resistance and whole-body vibration training', 'low-intensity resistance exercise training (LIRET) and whole-body vibration training (WBVT) with an external weighted vest']","['FMD', 'wave reflection indices', 'systemic endothelial function and muscle strength', 'brachial artery FMD (systemic effect), WBVT', 'aortic hemodynamics and vascular function', 'gait speed', 'arterial stiffness, wave reflection, brachial flow-mediated dilation (FMD), and physical performance', 'pulse pressure amplification (PPA', 'leg strength', 'WBVT', 'Arterial stiffness, augmentation index (AIx), augmented pressure (AP), brachial FMD, gait speed and leg strength']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0453884', 'cui_str': 'Waistcoat'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C2607857'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",33.0,0.0185631,"WBVT and LIRET elicited similar increases in leg strength (P = 0.001 and 0.019, respectively), compared to no improvement in the control group.","[{'ForeName': 'Salvador J', 'Initials': 'SJ', 'LastName': 'Jaime', 'Affiliation': 'University of Wisconsin-La Crosse, 1900 Pine St, La Crosse, WI, 54601, USA. sjaime@uwlax.edu.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Maharaj', 'Affiliation': 'Texas Tech University, 2500 Broadway, Lubbock, TX, 79409, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Alvarez-Alvarado', 'Affiliation': 'Florida State University, 1114W Call St, Tallahassee, FL, 32306, USA.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Figueroa', 'Affiliation': 'Texas Tech University, 2500 Broadway, Lubbock, TX, 79409, USA.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0328-1']
873,32493290,Pre-application of dentin bonding agent prevents discoloration caused by mineral trioxide aggregate.,"BACKGROUND
To evaluate tooth discoloration by newly developed calcium silicate-based materials, and to examine the pre-application of dentin bonding agent (DBA) for preventing discoloration caused by mineral trioxide aggregate (MTA).
METHODS
The roots of 50 premolars were randomly divided into five groups (n = 10) and cavities were prepared from resected root surfaces. MTA was placed in the cavities of teeth belonging to the ProRoot MTA (MTA) and RetroMTA (RMTA) groups. For teeth belonging to the ProRoot + DBA (MTA-B) and RetroMTA + DBA (RMTA-B) groups, DBA was first applied to the cavities prior to the addition of MTA. Teeth in the control group were restored with composite resin only (i.e., without MTA). After 12 weeks, MTA was removed from the MTA and RMTA groups and bleaching agents were applied for 3 additional weeks. Color assessments were recorded at baseline, and 1, 4, and 12 weeks, as well as after bleaching. A one-way ANOVA was performed to assess the differences between the two types of MTAs and color changes following DBA pre-application in each MTA group. A p-value of < 0.05 was considered indicative of statistical significance.
RESULTS
Following 12 weeks of MTA treatment, there was a significant difference between the discoloration in the MTA and RMTA groups (p < 0.05). However, no significant difference was observed between the RMTA and RMTA-B groups (p > 0.05). Following bleaching, the color changes (ΔE values) of the MTA group were not significantly different from those of the MTA-B group (p > 0.05). The difference of ΔE between the RMTA group after internal bleaching and the RMTA-B group was also not significant (p > 0.05).
CONCLUSIONS
RetroMTA caused significantly less discoloration than ProRoot MTA. Pre-application of DBA reduced discoloration caused by ProRoot MTA. MTA discoloration was improved equally well between DBA pre-application and post-bleaching.",2020,"However, no significant difference was observed between the RMTA and RMTA-B groups (p > 0.05).",['50 premolars'],"['MTA', 'RetroMTA']","['discoloration', 'MTA discoloration']","[{'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C4310582', 'cui_str': 'RetroMTA'}]","[{'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}]",50.0,0.0141938,"However, no significant difference was observed between the RMTA and RMTA-B groups (p > 0.05).","[{'ForeName': 'Yoo-Lim', 'Initials': 'YL', 'LastName': 'Choi', 'Affiliation': 'Department of Conservative Dentistry, College of Medicine, Ewha Womans University, 1071, Anyangcheon-ro, Yangcheon-gu, Seoul, 07985, South Korea.'}, {'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': 'Department of Conservative Dentistry, College of Medicine, Ewha Womans University, 1071, Anyangcheon-ro, Yangcheon-gu, Seoul, 07985, South Korea.'}, {'ForeName': 'Bom Sahn', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Department of Nuclear Medicine, College of Medicine, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Jin-Woo', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, College of Medicine, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Yemi', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, College of Medicine, Ewha Womans University, 1071, Anyangcheon-ro, Yangcheon-gu, Seoul, 07985, South Korea. yemis@ewha.ac.kr.'}]",BMC oral health,['10.1186/s12903-020-01151-1']
874,32191021,Are currently available biomarkers useful to discriminate CSU patients not controlled by low dose omalizumab maintenance therapy?,"Summary
In patients with Chronic Spontaneous Urticaria (CSU), low dose omalizumab maintenance therapy is effective in about one half of complete, fast responders to the drug. Omalizumab 150 mg/month was given as maintenance therapy to 21 patients with a history of severe CSU showing a complete (UAS7=0) response to the dose of 300 mg/month. After 2 months of such regimen, patients were divided into controlled (n=14; UAS7=0) and not controlled (n=7; UAS7 greater-than 10) and ESR, CRP, total IgE, and D-dimer were measured. The two groups did not differ in any of the biomarkers considered, nor in disease duration or in pre-treatment UAS7 score. The study confirms that it is possible to halve the dose of omalizumab without any loss of efficacy in a subgroup of patients with CSU but that none of the currently available biomarkers is able to predict which patients will lose disease control following omalizumab dose reduction.",2020,"The two groups did not differ in any of the biomarkers considered, nor in disease duration or in pre-treatment UAS7 score.",['patients with chronic spontaneous urticaria (CSU'],"['omalizumab maintenance therapy', 'Omalizumab']",['disease duration or in pre-treatment UAS7 score'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria (disorder)'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",21.0,0.0185876,"The two groups did not differ in any of the biomarkers considered, nor in disease duration or in pre-treatment UAS7 score.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Asero', 'Affiliation': 'Allergology clinic, Clinica San Carlo, Paderno Dugnano, Milan, Italy.'}]",European annals of allergy and clinical immunology,['10.23822/EurAnnACI.1764-1489.139']
875,31985516,Results of the NRG Oncology/RTOG 0848 Adjuvant Chemotherapy Question-Erlotinib+Gemcitabine for Resected Cancer of the Pancreatic Head: A Phase II Randomized Clinical Trial.,"PURPOSE
NRG/RTOG 0848 was designed to determine whether adjuvant radiation with fluoropyrimidine sensitization improved survival following gemcitabine-based adjuvant chemotherapy for patients with resected pancreatic head adenocarcinoma. In step 1 of this protocol, patients were randomized to adjuvant gemcitabine versus the combination of gemcitabine and erlotinib. This manuscript reports the final analysis of these step 1 data.
METHODS
Eligibility-within 10 weeks of curative intent pancreaticoduodenectomy with postoperative CA19-9<180. Gemcitabine arm-6 cycles of gemcitabine. Gemcitabine+erlotinib arm-gemcitabine and erlotinib 100 mg/d. Two hundred deaths provided 90% power (1-sided α=0.15) to detect the hypothesized OS signal (hazard ratio=0.72) in favor of the arm 2.
RESULTS
From November 17, 2009 to February 28, 2014, 163 patients were randomized and evaluable for arm 1 and 159 for arm 2. Median age was 63 (39 to 86) years. CA19-9 ≤90 in 93%. Arm 1: 32 patients (20%) grade 4 and 2 (1%) grade 5 adverse events; arm 2, 27 (17%) grade 4 and 3 (2%) grade 5. GI adverse events, arm 1: 22% grade ≥3 and arm 2: 28%, (P=0.22). The median follow-up (surviving patients) was 42.5 months (min-max: <1 to 75). With 203 deaths, the median and 3-year OS (95% confidence interval) are 29.9 months (21.7, 33.4) and 39% (30, 45) for arm 1 and 28.1 months (20.7, 30.9) and 39% (31, 47) for arm 2 (log-rank P=0.62). Hazard ratio (95% confidence interval) comparing OS of arm 2 to arm 1 is 1.04 (0.79, 1.38).
CONCLUSIONS
The addition of adjuvant erlotinib to gemcitabine did not provide a signal for increased OS in this trial.",2020,"GI adverse events, arm 1: 22% grade ≥3 and arm 2: 28%, (P=0.22).","['Resected Cancer of the Pancreatic Head', 'From November 17, 2009 to February 28, 2014, 163 patients were randomized and evaluable for arm 1 and 159 for arm 2', 'Median age was 63 (39 to 86) years', 'patients with resected pancreatic head adenocarcinoma', 'Eligibility-within 10 weeks of curative intent pancreaticoduodenectomy with postoperative CA19-9<180']","['Gemcitabine', 'fluoropyrimidine', 'gemcitabine and erlotinib', 'Adjuvant Chemotherapy Question-Erlotinib+Gemcitabine', 'gemcitabine-based adjuvant chemotherapy', 'gemcitabine', 'Gemcitabine+erlotinib arm-gemcitabine and erlotinib']","['median and 3-year OS', 'survival', 'Hazard ratio', 'hypothesized OS signal']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",163.0,0.114886,"GI adverse events, arm 1: 22% grade ≥3 and arm 2: 28%, (P=0.22).","[{'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Abrams', 'Affiliation': 'Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Winter', 'Affiliation': 'NRG Oncology Statistics and Data Management Center.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Safran', 'Affiliation': 'Rhode Island Hospital.'}, {'ForeName': 'Karyn A', 'Initials': 'KA', 'LastName': 'Goodman', 'Affiliation': 'University of Colorado Cancer Center, Denver, CO.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Regine', 'Affiliation': 'University of Maryland/Greenebaum Cancer Center, Baltimore, MD.'}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Berger', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Gillin', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Philip', 'Affiliation': 'Wayne State University/Karmanos Cancer Institute, Detroit, MI.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Lowy', 'Affiliation': 'UC San Diego Moores Cancer Center, San Diego.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Wu', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'DiPetrillo', 'Affiliation': 'Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Corn', 'Affiliation': 'Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Samantha A', 'Initials': 'SA', 'LastName': 'Seaward', 'Affiliation': 'Department of Radiation Oncology.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Haddock', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Suisui', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'USC/Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Yixing', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'University of Maryland/Greenebaum Cancer Center, Baltimore, MD.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Fisher', 'Affiliation': 'London Regional Cancer Program, London, ON, Canada.'}, {'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Katz', 'Affiliation': 'University of Rochester, Rochester, NY.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Spartanburg Regional Medical Center, Spartanburg, SC.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Willett', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Crane', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York.'}]",American journal of clinical oncology,['10.1097/COC.0000000000000633']
876,31473505,A diet of U.S. military food rations alters gut microbiota composition and does not increase intestinal permeability.,"Interactions between gut microbes and dietary components modulate intestinal permeability (IP) and inflammation. Recent studies have reported altered fecal microbiota composition together with increased IP and inflammation in individuals consuming military food rations in austere environments, but could not isolate effects of the diet from environmental factors. To determine how the U.S. Meal, Ready-to-Eat food ration affects fecal microbiota composition, IP and inflammation, 60 adults (95% male,18-61 years) were randomized to consume their usual ad libitum diet for 31 days (CON) or a strictly controlled Meal, Ready-to-Eat-only diet for 21 days followed by their usual diet for 10 days (MRE). In both groups, fecal microbiota composition was measured before, during (INT, days 1-21) and after the intervention period. IP and inflammation [high-sensitivity C-reactive protein (hsCRP)] were measured on days 0, 10, 21 and 31. Longitudinal changes in fecal microbiota composition differed between groups (P=.005), and fecal samples collected from MRE during INT were identified with 88% accuracy using random forest models. The genera making the strongest contribution to that prediction accuracy included multiple lactic acid bacteria (Lactobacillus, Lactococcus, Leuconostoc), which demonstrated lower relative abundance in MRE, and several genera known to dominate the ileal microbiota (Streptococcus, Veillonella, Clostridium), the latter two demonstrating higher relative abundance in MRE. IP and hsCRP were both lower (34% and 41%, respectively) in MRE relative to CON on day 21 (P<.05) but did not differ otherwise. Findings demonstrate that a Meal, Ready-to-Eat ration diet alters fecal microbiota composition and does not increase IP or inflammation.",2019,"IP and hsCRP were both lower (34% and 41%, respectively) in MRE relative to CON on day 21 (P<.05) but did not differ otherwise.","['60 adults (95% male,18-61 years']","['IP and inflammation [high-sensitivity C-reactive protein (hsCRP', 'consume their usual ad libitum diet for 31 days (CON) or a strictly controlled Meal, Ready-to-Eat-only diet for 21 days followed by their usual diet for 10 days (MRE']","['intestinal permeability', 'IP or inflammation', 'fecal microbiota composition']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1720467', 'cui_str': 'Only'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",60.0,0.0290759,"IP and hsCRP were both lower (34% and 41%, respectively) in MRE relative to CON on day 21 (P<.05) but did not differ otherwise.","[{'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Karl', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, 10 General Greene Ave, Natick, MA 01760, USA. Electronic address: James.p.karl.civ@mail.mil.'}, {'ForeName': 'Nicholes J', 'Initials': 'NJ', 'LastName': 'Armstrong', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, 10 General Greene Ave, Natick, MA 01760, USA. Electronic address: Nicholes.j.armstrong.civ@mail.mil.'}, {'ForeName': 'Holly L', 'Initials': 'HL', 'LastName': 'McClung', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, 10 General Greene Ave, Natick, MA 01760, USA. Electronic address: holly.l.mcclung.civ@mail.mil.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Player', 'Affiliation': 'Johns Hopkins University Applied Physics Laboratory, 11100 Johns Hopkins Rd, Laurel, MD 20723, USA. Electronic address: Robert.player@jhuapl.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Rood', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, USA. Electronic address: Jennifer.rood@pbrc.edu.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Racicot', 'Affiliation': 'Combat Feeding Directorate, U.S. Army Combat Capabilities Development Command-Soldier Center, 15 General Greene Ave, Natick, MA 01760, USA. Electronic address: Kenneth.racicot.civ@mail.mil.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Soares', 'Affiliation': 'Soldier Performance Optimization Directorate, U.S. Army Combat Capabilities Development Command-Soldier Center, 15 General Greene Ave, Natick, MA 01760, USA. Electronic address: Jason.w.soares.civ@mail.mil.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Montain', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, 10 General Greene Ave, Natick, MA 01760, USA. Electronic address: scott.j.montain.civ@mail.mil.'}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2019.108217']
877,29741754,Probiotics to Prevent Respiratory Infections in Nursing Homes: A Pilot Randomized Controlled Trial.,"OBJECTIVES
To assess the feasibility of conducting a large clinical trial to evaluate the effectiveness of probiotics to reduce influenza and other respiratory virus infections in residents of long-term and chronic care facilities (LTCFs).
DESIGN
Randomized, double-blind, placebo-controlled pilot trial.
SETTING
Fourteen nursing homes in Hamilton and surrounding region, Ontario, Canada.
PARTICIPANTS
Nursing home residents aged 65 and older (N=209). Those who were taking immunosuppressives (steroids or other immunosuppressives) or had a hematological malignancy, structural heart disease, or gastroesophageal or intestinal injury and others at high risk of an endovascular infection were excluded.
INTERVENTION
Participants were randomized to receive study probiotics-2 capsules of Lactobacillus rhamnosus GG (estimated 10 billion colony forming units of L. rhamnosus GG per capsule) or placebo (calcium carbonate) daily for 6 months.
MEASUREMENTS
Laboratory-confirmed respiratory viral infections.
RESULTS
One hundred ninety-six individuals were included in the analysis: 100 in the probiotics group and 96 in the placebo group. Laboratory-confirmed respiratory viral infections were observed in 14 (15.0%) residents in the probiotic group and 21 (22.9%) in the placebo group (hazard ratio=0.65, 95% confidence interval=0.32-1.31).
CONCLUSION
A larger trial is warranted to determine whether probiotics reduce influenza and other respiratory virus infections in residents of LTCFs.",2018,"Laboratory-confirmed respiratory viral infections were observed in 14 (15.0%) residents in the probiotic group and 21 (22.9%) in the placebo group (hazard ratio=0.65, 95% confidence interval=0.32-1.31).
","['Nursing home residents aged 65 and older (N=209', 'Nursing Homes', 'Fourteen nursing homes in Hamilton and surrounding region, Ontario, Canada', 'residents of LTCFs', 'residents of long-term and chronic care facilities (LTCFs', 'One hundred ninety-six individuals were included in the analysis: 100 in the probiotics group and 96 in the placebo group', 'Those who were taking immunosuppressives (steroids or other immunosuppressives) or had a hematological malignancy, structural heart disease, or gastroesophageal or intestinal injury and others at high risk of an endovascular infection were excluded']","['placebo (calcium carbonate', 'Probiotics', 'placebo', 'probiotics-2 capsules of Lactobacillus rhamnosus GG']",['Laboratory-confirmed respiratory viral infections'],"[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0042769', 'cui_str': 'Viral Infections'}]",196.0,0.705765,"Laboratory-confirmed respiratory viral infections were observed in 14 (15.0%) residents in the probiotic group and 21 (22.9%) in the placebo group (hazard ratio=0.65, 95% confidence interval=0.32-1.31).
","[{'ForeName': 'Biao', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Hylwka', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Smieja', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Surrette', 'Affiliation': 'Department of Biochemistry and Biomedical Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Dawn M E', 'Initials': 'DME', 'LastName': 'Bowdish', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Loeb', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15396']
878,31504390,Effect of verbal and written information on pain perception in patients undergoing fixed orthodontic treatment: a randomized controlled trial.,"BACKGROUND
Pain can discourage patients from seeking orthodontic treatment or compromise their compliance during therapy.
OBJECTIVES
To determine the effects of verbal and written information on orthodontic pain after fixed appliance placement.
TRIAL DESIGN
Two-arm parallel design randomized controlled trial.
METHODS
Healthy adolescents with permanent dentition enrolled for orthodontic treatment were assigned to the study or control group using computer-generated random lists and allocation concealment with sealed envelopes. Participants completed baseline questionnaires to assess anxiety (State-Trait Anxiety Inventory Trait Version, Form X-2) and somatosensory amplification (Somatosensory Amplification Scale). Brackets were placed in the maxillary arch, from first molar to first molar, and an Australian archwire 0.012 inch was used for alignment. General verbal information on orthodontic treatment was given to all patients by the same clinician. Participants included in the study group received also detailed verbal instructions on orthodontic pain together with a take-home information leaflet by another clinician. Outcome included assessments of pain intensity with a Numerical Rating Scale (NRS) on the day of appliance placement (Day 1, bedtime) and twice a day for the following 6 days (Day 2 to Day 7, morning, bedtime), and analgesic consumption. Participants, statistician, and clinicians who gave general verbal information on orthodontic treatment and instructions about how to score pain intensity were blinded to group assignment.
RESULTS
Sixty patients were assigned to the study (n = 30, mean age: 15.4 ± 1.3 years) or control group (n = 30, mean age: 14.7 ± 3.2 years). At baseline, no significant between-group differences were present in terms of anxiety and somatosensory amplification. Orthodontic pain scores were significantly lower in the study group compared with the control one, at bedtime on Day 1 (P < 0.05) and in the morning of Day 2 (P < 0.01). No significant between-group differences were found in following measurements. Overall, analgesic consumption was significantly lower in study compared with the control (P < 0.01).
CONCLUSION
A combination of verbal and written information on orthodontic pain after placement of fixed appliances reduced patient's self-reported pain in the early stages.
REGISTRATION
This study was not registered.",2020,"A combination of verbal and written information on orthodontic pain after placement of fixed appliances reduced patient's self-reported pain in the early stages.
","['patients undergoing fixed orthodontic treatment', ""orthodontic pain after placement of fixed appliances reduced patient's self-reported pain in the early stages"", 'Sixty patients were assigned to the study (n = 30, mean age: 15.4 ± 1.3 years) or control group (n = 30, mean age: 14.7 ± 3.2 years', 'Participants, statistician, and clinicians who gave general verbal information on orthodontic treatment and instructions about how to score pain intensity', 'Healthy adolescents with permanent dentition enrolled for orthodontic treatment']","['control group using computer-generated random lists and allocation concealment with sealed envelopes', 'detailed verbal instructions on orthodontic pain together with a take-home information leaflet by another clinician', 'verbal and written information']","['pain intensity with a Numerical Rating Scale (NRS) on the day of appliance placement (Day 1, bedtime) and twice a day for the following 6 days (Day 2 to Day 7, morning, bedtime), and analgesic consumption', 'anxiety and somatosensory amplification', 'General verbal information', 'pain perception', 'anxiety (State-Trait Anxiety Inventory Trait Version, Form X-2) and somatosensory amplification (Somatosensory Amplification Scale', 'Overall, analgesic consumption', 'Orthodontic pain scores', 'orthodontic pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0441421', 'cui_str': 'Permanent Retainer'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517579', 'cui_str': '15.4 (qualifier value)'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0334957', 'cui_str': 'Statistician (occupation)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent (finding)'}, {'cui': 'C0348070', 'cui_str': 'Dentition, Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0243112'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.194287,"A combination of verbal and written information on orthodontic pain after placement of fixed appliances reduced patient's self-reported pain in the early stages.
","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Montebugnoli', 'Affiliation': ""Department of Neurosciences, Reproductive Sciences and Oral Sciences, Section of Orthodontics, University of Naples 'Federico II'.""}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Incerti Parenti', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM), Section of Orthodontics, University of Bologna, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': ""D'Antò"", 'Affiliation': ""Department of Neurosciences, Reproductive Sciences and Oral Sciences, Section of Orthodontics, University of Naples 'Federico II'.""}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Alessandri-Bonetti', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM), Section of Orthodontics, University of Bologna, Italy.'}, {'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Michelotti', 'Affiliation': ""Department of Neurosciences, Reproductive Sciences and Oral Sciences, Section of Orthodontics, University of Naples 'Federico II'.""}]",European journal of orthodontics,['10.1093/ejo/cjz068']
879,15854463,[Effect of enucleation of hysteromyoma by laparoscopic surgery on protein oxidation and lipid hyperoxidation].,"OBJECTIVE
To evaluate the effect of laparoscopic surgery on and lipid hyperoxidation in patients with hysteromyoma.
METHODS
Forty patients with hysteromyoma were randomly divided into 2 equal groups: laparoscopy group and laparotomy group. The plasma advanced oxidation protein products (AOPP), malondialdehyde (MDA), antioxidant activity (AOA), and glutathione peroxidase (GPx) activity were measured before operation, just after operation (5 minutes after deflation) and 24 hours after operation.
RESULTS
(1) In the laparoscopy group, the levels of AOPP and MDA were (50.20 +/- 9.23) micromol/L and (1.85 +/- 0.19) micromol/L before operation, increased significantly just after operation [(68.75 +/- 12.69) micromol/L and (2.52 +/- 0.55) micromol/L respectively, both P < 0.01], and recovered to the normal level 24 hour postoperatively [(49.70 +/- 9.92) micromol/L and (2.05 +/- 0.68) micromol/L respectively, both P > 0.05]. The levels of GPx and AOA decreased significantly just after operation [(0.29 +/- 0.09) U/ml vs. (0.62 +/- 0.27) U/mL and (0.90 +/- 0.24) mmol/L vs. (1.41 +/- 0.39) mmol/L respectively, both P < 0.01], and the GPx level recovered 24 hours after operation [(0.52 +/- 0.06) U/mL, P > 0.05], however, the AOA level was still lower [(1.00 +/- 0.31) mmol/L, P < 0.01]. In the laparotomy group, the levels of plasma AOPP and MDA level slightly increased just after operation in comparison with those before operation [(53.39 +/- 9.86) micromol/L vs. (52.30 +/- 7.10) micromol/L and (2.09 +/- 0.51) micromol/L vs. (1.83 +/- 0.64) micromol/L respectively, both P > 0.05] and continued to increase 24 hours after operation [(63.40 +/- 15.5) micromol/L, P < 0.05, and (2.42 +/- 0.44) micromol/L, P < 0.01]; the GPx and AOA levels decreased a little just after operation [(0.51 +/- 0.17) U/mL vs. (0.57 +/- 0.21) U/mL and (1.20 +/- 0.46) mmol/L vs. (1.33 +/- 0.37) mmol/L, both P > 0.05] and continued to decrease 24 hours after operation [(0.35 +/- 0.19) U/mL and (0.92 +/- 0.22) mmol/L respectively, both P < 0.01]. Compared with those of the laparotomy group, the plasma AOPP and MDA levels of the laparoscopy group were both significantly lower (P < 0.01 and P < 0.05), and the GPx level was significantly higher (P < 0.01) 24 hours after operation, however, the AOA level was not significantly different (P > 0.05).
CONCLUSION
Laparoscopic surgery is better than laparotomy. Protein oxidation and lipid hyperoxidation occur during the laparoscopic surgery, however, disappeared after operation. Free radicals are generated by the end of laparoscopic procedure, possibly as a result of an ischemia-reperfusion phenomenon induced by the inflation and deflation of the pneumoperitoneum. AOPP and MDA are induced during laparoscopic procedure and then return to the normal levels finally.",2005,"In the laparotomy group, the levels of plasma AOPP and MDA level slightly increased just after operation in comparison with those before operation [(53.39 +/-","['Forty patients with hysteromyoma', 'patients with hysteromyoma']","['Laparoscopic surgery', 'laparoscopy group and laparotomy group', 'enucleation of hysteromyoma by laparoscopic surgery', 'laparoscopic surgery']","['plasma AOPP and MDA levels', 'GPx level', 'AOPP and MDA', 'Protein oxidation and lipid hyperoxidation', 'plasma advanced oxidation protein products (AOPP), malondialdehyde (MDA), antioxidant activity (AOA), and glutathione peroxidase (GPx) activity', 'protein oxidation and lipid hyperoxidation', 'levels of plasma AOPP and MDA level', 'AOA level', 'levels of GPx and AOA', 'levels of AOPP and MDA', 'GPx and AOA levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2747862', 'cui_str': 'Hysteromyoma'}]","[{'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C2747862', 'cui_str': 'Hysteromyoma'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1976991', 'cui_str': 'AOPPs'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}]",40.0,0.0170033,"In the laparotomy group, the levels of plasma AOPP and MDA level slightly increased just after operation in comparison with those before operation [(53.39 +/-","[{'ForeName': 'Guang-liang', 'Initials': 'GL', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Nanfang Hospital, Guangzhou 510515, China.'}, {'ForeName': 'Wei-qun', 'Initials': 'WQ', 'LastName': 'Wen', 'Affiliation': ''}, {'ForeName': 'Fu-qi', 'Initials': 'FQ', 'LastName': 'Xing', 'Affiliation': ''}]",Zhonghua yi xue za zhi,[]
880,31504798,"Smoking Cessation in the ITALUNG Lung Cancer Screening: What Does ""Teachable Moment"" Mean?","BACKGROUND
Changes in smoking habits and predictors of smoking cessation were examined in the randomized ITALUNG lung cancer screening trial.
METHODS
In three centers, eligible smokers or ex-smokers (55-69 years, ≥20 pack-years in the last 10 years) were randomized to receive annual invitation for low-dose computed tomography for 4 years or usual care. At invitation, subjects received written information for a free smoking cessation program. Quitting outcome was assessed at year 4.
RESULTS
Among participants who completed baseline assessments and year 4 screening, higher quitting (20.8% vs. 16.7%, p = .029) and lower relapse (6.41% vs. 7.56%, p = .50) rates were observed in the active screening group as compared to the usual-care control group. Corresponding figures in the intention-to-treat analysis were as follows: 16.04% versus 14.64% (p = .059) and 4.88% versus 6.43% (p = .26). Quitting smoking was significantly associated to male gender, lower pack-years, and having pulmonary nodules at baseline. Center-specific analyses showed a threefold statistically significant higher probability to quit associated with participating in the smoking cessation program. A subsample of smokers of the scan group from one center showed higher quitting rates over 12-month follow-up as compared to matched controls from the general population who underwent the same smoking cessation program.
CONCLUSIONS
Consistently with previous reports, in the ITALUNG trial, screened subjects showed significantly higher quit rates than controls, and higher quit rates were associated with both the presence of pulmonary nodules and participating in a smoking cessation program. Maximal effect on quitting outcome was observed with the participation in the smoking cessation program.
IMPLICATIONS
Participating in lung cancer screening promotes smoking cessation. An effective ""teachable moment"" may be achieved when the smoking cessation intervention is structured as integral part of the screening clinical visits and conducted by a dedicated team of health care professionals. Standardized guidelines for smoking cessation interventions in lung cancer screening are needed.",2020,Center-specific analyses showed a three-fold statistically significant higher probability to quit associated with participating in the smoking cessation program.,"['eligible smokers or ex-smokers (55-69 years, ≥ 20 pack-years in the last 10 years', 'Participating in lung cancer screening promotes smoking cessation', 'lung cancer screening']",['annual invitation for low-dose computed tomography for 4 years or usual care'],"['Quitting outcome', 'quit rates', 'quitting rates', 'Smoking cessation', 'Quitting smoking', 'quitting outcome', 'lower relapse']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4555205', 'cui_str': 'Ex-Smokers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.0174261,Center-specific analyses showed a three-fold statistically significant higher probability to quit associated with participating in the smoking cessation program.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pistelli', 'Affiliation': 'Pulmonary Unit, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Ferruccio', 'Initials': 'F', 'LastName': 'Aquilini', 'Affiliation': 'Pulmonary Unit, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Falaschi', 'Affiliation': '2nd Radiodiagnostic Unit, Department of Diagnostic Imaging, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Donella', 'Initials': 'D', 'LastName': 'Puliti', 'Affiliation': 'Clinical Epidemiology Unit, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ocello', 'Affiliation': 'Clinical Epidemiology Unit, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lopes Pegna', 'Affiliation': 'Formerly Pneumonology Department, University Hospital Careggi, Florence, Italy.'}, {'ForeName': 'Francesca Maria', 'Initials': 'FM', 'LastName': 'Carozzi', 'Affiliation': 'Cancer Prevention Regional Laboratory, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Picozzi', 'Affiliation': 'Clinical Breast Unit, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy, Florence, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Zappa', 'Affiliation': 'Clinical Epidemiology Unit, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mascalchi', 'Affiliation': 'Formerly Clinical Epidemiology Unit, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Paci', 'Affiliation': 'Clinical Epidemiology Unit, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Carrozzi', 'Affiliation': 'Pulmonary Unit, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz148']
881,31476161,"Clinical Benefits of Antioxidative Supplement Twendee X for Mild Cognitive Impairment: A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Prospective Interventional Study.","Oxidative stress is part of the entire pathological process that underlies the development of Alzheimer's disease (AD), including the mild cognitive impairment (MCI) stage. Twendee X (TwX) is a supplement containing a strong antioxidative mix of eight antioxidants, which has been shown to have a clinical and therapeutic benefit in AD model mice. Here, we conducted a multicenter, randomized, double-blind, and placebo-controlled prospective interventional study to evaluate the efficacy of TwX in mitigating MCI. The primary outcomes were differences in Mini-Mental State Examination (MMSE) and Hasegawa Dementia Scale-revised (HDS-R) scores between baseline and six months for placebo and TwX groups. Seventy-eight subjects with MCI were randomized into placebo (n = 37) and TwX (n = 41) groups. MMSE scores at six months differed significantly between the TwX and placebo groups (p = 0.018), and HDS-R scores for the TwX group exhibited a significant improvement at six months relative to baseline (p = 0.025). The TwX group did not show any change in affective or activities of daily living scores at six months. The present study indicates that strong antioxidative supplement TwX is clinical beneficial for cognitive function in subjects with MCI.",2019,"MMSE scores at six months differed significantly between the TwX and placebo groups (p = 0.018), and HDS-R scores for the TwX group exhibited a significant improvement at six months relative to baseline (p = 0.025).","['Seventy-eight subjects with MCI', 'Mild Cognitive Impairment', 'subjects with MCI']","['Antioxidative Supplement Twendee X', 'TwX and placebo', 'placebo', 'Twendee X (TwX', 'TwX', 'Placebo']","['Mini-Mental State Examination (MMSE) and Hasegawa Dementia Scale-revised (HDS-R) scores', 'MMSE scores', 'HDS-R scores', 'affective or activities of daily living scores']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}]",78.0,0.543298,"MMSE scores at six months differed significantly between the TwX and placebo groups (p = 0.018), and HDS-R scores for the TwX group exhibited a significant improvement at six months relative to baseline (p = 0.025).","[{'ForeName': 'Koh', 'Initials': 'K', 'LastName': 'Tadokoro', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Morihara', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Ohta', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Nozomi', 'Initials': 'N', 'LastName': 'Hishikawa', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Kawano', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Sasaki', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Namiko', 'Initials': 'N', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Nomura', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Nakano', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Mami', 'Initials': 'M', 'LastName': 'Takemoto', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}, {'ForeName': 'Setsuko', 'Initials': 'S', 'LastName': 'Ueno', 'Affiliation': 'Department of Neurology, Kurashiki Heisei Hospital, Kurashiki, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Wakutani', 'Affiliation': 'Department of Neurology, Kurashiki Heisei Hospital, Kurashiki, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Takao', 'Affiliation': 'Department of Neurology, Kurashiki Heisei Hospital, Kurashiki, Japan.'}, {'ForeName': 'Nobutoshi', 'Initials': 'N', 'LastName': 'Morimoto', 'Affiliation': 'Department of Neurology, Kagawa Prefectural Central Hospital, Takamatsu, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Kutoku', 'Affiliation': 'Department of Neurology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Yoshihide', 'Initials': 'Y', 'LastName': 'Sunada', 'Affiliation': 'Department of Neurology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Katsushi', 'Initials': 'K', 'LastName': 'Taomoto', 'Affiliation': 'Department of Neurosurgery, Ohnishi Neurological Center, Akashi, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Manabe', 'Affiliation': 'Department of Neurology, National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Deguchi', 'Affiliation': 'Department of Neurology, Okayama City Hospital, Okayama, Japan.'}, {'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Higashi', 'Affiliation': 'Department of Neurology, Himeji Central Hospital, Himeji, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Inufusa', 'Affiliation': 'Division of Anti-Oxidant Research, Life Science Research Center, Gifu University, Gifu, Japan.'}, {'ForeName': 'Fukka', 'Initials': 'F', 'LastName': 'You', 'Affiliation': 'Division of Anaerobe Research, Life Science Research Center, Gifu University, Gifu, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Louis Pasteur Center for Medical Research, Kyoto, Japan.'}, {'ForeName': 'Markus Matuschka', 'Initials': 'MM', 'LastName': 'von Greiffenclau', 'Affiliation': 'European Medical Foundation, TIMA Est., Balzers, Liechtenstein.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190644']
882,32436655,"Novel, digital, chest drainage system in cardiac surgery.","BACKGROUND
A new, self-contained, digital, continuous pump-driven chest drainage system is compared in a randomized control trial to a traditional wall-suction system in cardiac surgery.
METHODS
One hundred and twenty adult elective cardiac patients undergoing coronary artery bypass graft and/or valve surgery were randomized to the study or control group. Both groups had similar pre/intra-operative demographics: age 67.8 vs 67.0 years, Euroscore 2.3 vs 2.2, and body surface area 1.92 vs 1.91 m 2 . Additionally, a satisfaction assessment score (0-10) was performed by 52 staff members.
RESULTS
Given homogenous intra-operative variables, total chest-tube drainage was comparable among groups (566 vs 640 mL; ns), but the study group showed more efficient fluid collection during the early postoperative phase due to continuous suction (P = .01). Blood, cell saver transfusions and postoperative hemoglobin values were similar in both groups. The study group experienced drain removal after 29.8 vs 38.4 hours in the control group (ns). Seven crossovers from the Study to the Control group were registered but no patient had drain-related complications. The Personnel Satisfaction Assessment scored above 5 for all questions asked.
CONCLUSIONS
The new, digital, chest drainage system showed better early drainage of the chest cavity and was as reliable as conventional systems. Quicker drain removal might impact on intensive care unit (ICU) stay and reduce costs. Additional advantages are portable size, battery operation, patient mobility, noiseless function, digital indications and alarms. The satisfaction assessment of the new system by the staff revealed a higher score when compared to the traditional wall suction chest drainage system.",2020,"The new, digital, chest drainage system showed better early drainage of the chest cavity and was as reliable as conventional systems.","['Both groups had similar pre/intra-operative demographics: age 67.8 vs 67.0 years, Euroscore 2.3 vs 2.2, and body surface area 1.92 vs 1.91 m 2 ', 'and/or valve surgery', 'One hundred and twenty adult elective cardiac patients undergoing', 'cardiac surgery']",['coronary artery bypass graft'],"['drain-related complications', 'drain removal', 'Blood, cell saver transfusions and postoperative hemoglobin values', 'total chest-tube drainage', 'intensive care unit (ICU) stay and reduce costs', 'satisfaction assessment score', 'efficient fluid collection']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3164744', 'cui_str': 'European system for cardiac operative risk evaluation'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0600644', 'cui_str': 'Collection'}]",120.0,0.0347734,"The new, digital, chest drainage system showed better early drainage of the chest cavity and was as reliable as conventional systems.","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Barozzi', 'Affiliation': 'Division of Cardiac Surgery, University of Verona, Verona, Italy.'}, {'ForeName': 'Livio San', 'Initials': 'LS', 'LastName': 'Biagio', 'Affiliation': 'Division of Cardiac Surgery, University of Verona, Verona, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Meneguzzi', 'Affiliation': 'Division of Cardiac Surgery, University of Verona, Verona, Italy.'}, {'ForeName': 'Delphine S', 'Initials': 'DS', 'LastName': 'Courvoisier', 'Affiliation': 'Quality of Care Unit, University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Beat H', 'Initials': 'BH', 'LastName': 'Walpoth', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Faggian', 'Affiliation': 'Division of Cardiac Surgery, University of Verona, Verona, Italy.'}]",Journal of cardiac surgery,['10.1111/jocs.14629']
883,31882288,Temporal Summation in Chronic Pelvic Pain.,"OBJECTIVE
This study sought to characterize central sensitization further among women with chronic pelvic pain by identifying temporal summation using a cotton-tipped applicator test that can be used at the bedside.
METHOD
A total of 36 women (18 with chronic pain and allodynia; 18 without pain) were recruited. Both groups were randomly assigned to receive 3 strokes of a benign stimulus on the abdomen at differing frequencies: 10, 30, or 100 seconds. Each group included 6 women. Pain was assessed using a rating scale of 1 to 10. Data were analyzed using the multivariate approach to repeated measures analysis of variance.
RESULTS
The pattern of pain scores differed significantly between women with and without chronic pain (P = 0.002). Women with chronic pelvic pain and allodynia showed a statistically significant increase in pain with successive strokes of the cotton-tipped applicator (P = 0.012 for stroke 1 vs. 2, P = 0.026 for stroke 2 vs. 3, and P = 0.005 for stroke 1 vs. 3).
CONCLUSION
Women with chronic pelvic pain and allodynia showed significant worsening of pain with successive strokes of a cotton-tipped applicator. This finding indicates that pain wind-up and central sensitization are present in women with chronic pelvic pain and allodynia. Identification of summation is further evidence of neuroplasticity, which is helpful in innovative therapies for chronic pelvic pain.",2020,"Women with chronic pelvic pain and allodynia showed a statistically significant increase in pain with successive strokes of the Q-tip (P = 0.012 for stroke 1 vs. 2, P = 0.026 for stroke 2 vs. 3, and P = 0.005 for stroke 1 vs. 3).
","['chronic pelvic pain', 'women with chronic pelvic pain and allodynia', 'women with chronic pelvic pain', 'Chronic Pelvic Pain', '36 women (18 with chronic pain and allodynia; 18 without pain']",[],"['pain with successive strokes of the Q-tip', 'chronic pelvic pain and allodynia', 'Pain', 'pattern of pain scores']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C1286321', 'cui_str': 'Pattern of pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",36.0,0.0823387,"Women with chronic pelvic pain and allodynia showed a statistically significant increase in pain with successive strokes of the Q-tip (P = 0.012 for stroke 1 vs. 2, P = 0.026 for stroke 2 vs. 3, and P = 0.005 for stroke 1 vs. 3).
","[{'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Thompson', 'Affiliation': 'Department of Obstetrics and Gynecology, Cumming School of Medicine, University of Calgary, Calgary, AB.'}, {'ForeName': 'Selphee', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Obstetrics and Gynecology, Cumming School of Medicine, University of Calgary, Calgary, AB.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Jarrell', 'Affiliation': 'Department of Obstetrics and Gynecology, Cumming School of Medicine, University of Calgary, Calgary, AB. Electronic address: john.jarrell@ahs.ca.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2019.09.012']
884,31495655,"Efficacy of RehaCom cognitive rehabilitation software in activities of daily living, attention and response control in chronic stroke patients.","BACKGROUND
Our world is unfortunately facing a huge number of stroke. Attention, response control and activities of daily living (ADL) are important cognitive functions affected by stroke. In line with this explanation, we aimed to investigate the effect of RehaCom rehabilitation software on ADL, attention and response control in chronic stroke patients with damage to middle and anterior cerebral arteries.
METHOD
For selecting participants, among chronic stroke patients who referred to our special rehabilitation clinic for patients with stroke, fifty patients selected. Participants were assigned to control (n = 25) and experimental (n = 25) groups. The experimental group was compared with the control group before and after using RehaCom (ten 45-min sessions in five weeks).
RESULTS
There is a significant enhancement in ADL, attention and response control scores in the experimental group compared with the control group. In fact, treatment with RehaCom significantly improved the score of all studied variables in chronic stroke patients.
CONCLUSIONS
In conclusion, RehaCom cognitive rehabilitation software has improvement effect on ADL, attention and response control in patients with chronic stroke. Our study reveals a new information about the efficacy of computerized training in the rehabilitation of stroke patients.",2020,"There is a significant enhancement in ADL, attention and response control scores in the experimental group compared with the control group.","['stroke patients', 'patients with chronic stroke', 'For selecting participants, among chronic stroke patients who referred to our special rehabilitation clinic for patients with stroke, fifty patients selected', 'chronic stroke patients', 'chronic stroke patients with damage to middle and anterior cerebral arteries']","['RehaCom rehabilitation software', 'RehaCom cognitive rehabilitation software', 'computerized training', 'RehaCom']","['ADL, attention and response control scores', 'Attention, response control and activities of daily living (ADL', 'ADL, attention and response control', 'activities of daily living, attention and response control']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic (environment)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3816723', 'cui_str': '50 (qualifier value)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0149561', 'cui_str': 'Anterior Cerebral Artery'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",50.0,0.0263718,"There is a significant enhancement in ADL, attention and response control scores in the experimental group compared with the control group.","[{'ForeName': 'Saboora', 'Initials': 'S', 'LastName': 'Veisi-Pirkoohi', 'Affiliation': 'Department of Psychology, Faculty of Medicine, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Hassani-Abharian', 'Affiliation': 'Institute for Cognitive Science Studies (ICSS), Tehran, Iran.'}, {'ForeName': 'Rouzbeh', 'Initials': 'R', 'LastName': 'Kazemi', 'Affiliation': 'TABASOM Rehabilitation Center for Stroke Patients, Tehran, Iran.'}, {'ForeName': 'Salar', 'Initials': 'S', 'LastName': 'Vaseghi', 'Affiliation': 'Cognitive and Neuroscience Research Center (CNRC), Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Zarrindast', 'Affiliation': 'Department of Pharmacology School of Medicine, Tehran University of Medical Sciences, Tehran, Iran; Department of Neuroendocrinology, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Nasehi', 'Affiliation': 'Cognitive and Neuroscience Research Center (CNRC), Tehran Medical Sciences, Islamic Azad University, Tehran, Iran. Electronic address: Nasehi@iricss.org.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2019.08.114']
885,31495658,"""Sequential multimodality stimulation"" for post-stroke-hemineglect: Feasibility and outcome in a pilot randomized controlled trial.","OBJECTIVE
To test the feasibility and efficacy of multimodality stimulation combined with motor tasking as a corrective strategy for hemineglect following right hemispheric ischemic strokes.
MATERIAL AND METHODS
A prospective randomized controlled single blinded clinical trial was conducted over eighteen months from January 2017. All patients with right hemispheric ischemic strokes were screened for hemineglect and those fulfilling criteria were recruited and randomized. Patients under the therapy group (TG) received the intervention based on a structured protocol in addition to standard physiotherapy. The control group (CG) received standard physiotherapy alone. NIHSS, mRS and Neuropsychological test scores were recorded at different time points. The primary outcome measures (neuropsychological test scores) were compared between the two groups (Student's t-test to find out the difference in outcome measures) at one and three months post-stroke.
RESULTS
Of the 14 patients recruited, data from 12 were available for analysis, 5 patients in TG and 7 in CG. There was a trend for better hemineglect and functional outcomes in TG.
CONCLUSION
Multimodality stimulation, in addition to standard physiotherapy, is feasible and potentially results in better neurocognitive and functional recovery following right hemispheric ischemic strokes. However, larger studies are warranted to prove these preliminary observations beyond doubt.",2020,"There was a trend for better hemineglect and functional outcomes in TG.
CONCLUSION
Multimodality stimulation, in addition to standard physiotherapy, is feasible and potentially results in better neurocognitive and functional recovery following right hemispheric ischemic strokes.","['All patients with right hemispheric ischemic strokes were screened for hemineglect and those fulfilling criteria were recruited and randomized', '14 patients recruited', 'eighteen months from January 2017']","['standard physiotherapy alone', 'multimodality stimulation combined with motor tasking', 'Sequential multimodality stimulation', 'intervention based on a structured protocol in addition to standard physiotherapy']","['NIHSS, mRS and Neuropsychological']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",[],,0.191936,"There was a trend for better hemineglect and functional outcomes in TG.
CONCLUSION
Multimodality stimulation, in addition to standard physiotherapy, is feasible and potentially results in better neurocognitive and functional recovery following right hemispheric ischemic strokes.","[{'ForeName': 'Sajith', 'Initials': 'S', 'LastName': 'Sukumaran', 'Affiliation': 'Comprehensive Stroke Care Centre, Department of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, India. Electronic address: sajith@sctimst.ac.in.'}, {'ForeName': 'Sesh', 'Initials': 'S', 'LastName': 'Sivadasan', 'Affiliation': 'Comprehensive Stroke Care Centre, Department of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, India.'}, {'ForeName': 'Parthan T', 'Initials': 'PT', 'LastName': 'Sakunthala', 'Affiliation': 'Comprehensive Stroke Care Centre, Department of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, India.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Tandon', 'Affiliation': 'Comprehensive Stroke Care Centre, Department of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, India.'}, {'ForeName': 'Sankara P', 'Initials': 'SP', 'LastName': 'Sarma', 'Affiliation': 'Department of Biostatistics, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, India.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2019.08.112']
886,32103423,Using conceptual change theory to help preservice teachers understand dyslexia.,"Recently, many states passed laws requiring pre- and in-service teachers to receive professional development in dyslexia awareness. Even though misconceptions regarding dyslexia are widespread, there is a paucity of research on how to effectively remove misconceptions and replace them with accurate knowledge. The purpose of this study was to determine whether a researcher-created refutation text grounded in conceptual change theory could produce significant conceptual change in preservice teacher knowledge of dyslexia when compared with a control text about dyslexia (Dyslexia Basics, International Dyslexia Association; IDA, 2018). A sample of preservice teachers (n = 97) was randomly assigned to either the Dyslexia Basics text (n = 48) or the refutation text (n = 49). A one-way repeated ANOVA was used to identify if growth rates from pretest to posttest were differential across conditions. Results suggest that while both texts affect conceptions, the refutation text outperformed the Dyslexia Basics text (n = 97), η 2 = 0.33. Effects were maintained at a delayed posttest (n = 75), η 2 = 0.175. Interaction effects suggested that the amount of reading coursework did not moderate conceptual change. Implications for facilitating conceptual change of dyslexia will be discussed.",2020,"Results suggest that while both texts affect conceptions, the refutation text outperformed the Dyslexia Basics text (n = 97), η 2 = 0.33.",['A sample of preservice teachers (n\u2009=\u200997'],['Dyslexia Basics text (n\u2009=\u200948) or the refutation text'],[],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}]","[{'cui': 'C0476254', 'cui_str': 'Reading Disorder'}, {'cui': 'C3541382', 'cui_str': 'Text'}]",[],,0.0231927,"Results suggest that while both texts affect conceptions, the refutation text outperformed the Dyslexia Basics text (n = 97), η 2 = 0.33.","[{'ForeName': 'Tiffany K', 'Initials': 'TK', 'LastName': 'Peltier', 'Affiliation': 'Department of Educational Psychology, University of Oklahoma, Norman, OK, 73019-2041, USA. tpeltier@ou.edu.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Heddy', 'Affiliation': 'Department of Educational Psychology, University of Oklahoma, Norman, OK, 73019-2041, USA.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Peltier', 'Affiliation': 'Department of Educational Psychology, University of Oklahoma, Norman, OK, 73019-2041, USA.'}]",Annals of dyslexia,['10.1007/s11881-020-00192-z']
887,30848783,Reasons for hospitalization and risk of mortality in patients with atrial fibrillation treated with dabigatran or warfarin in the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial.,"AIMS
Hospitalizations are common among patients with atrial fibrillation. This article aimed to analyse the causes and consequences of hospitalizations occurring during the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial.
METHODS AND RESULTS
The RE-LY database was used to evaluate predictors of hospitalization using multivariate regression modelling. The relationship between hospitalization and subsequent major adverse cardiac events was evaluated in a time dependent Cox proportional-hazard modelling. Of the 18 113 patients in RE-LY, 7200 (39.8%) were hospitalized at least once during a mean follow-up of 2 years. First hospitalization rates were 2312 (39.5%) for dabigatran etexilate (DE) 110, 2430 (41.6%) for DE 150, and 42.6% (N = 2458) for warfarin. Hospitalization was associated with post-discharge death [absolute event rate 9.1% vs. 2.2%; adjusted hazard ratio (HR) 3.6, 95% confidence interval (CI) 3.2-4.0, P < 0.0001], vascular death (adjusted HR 2.9, 95% CI 2.5-3.3, P < 0.0001), and sudden cardiac death (adjusted HR 2.3; 95% CI 1.8-2.9, P < 0.0001). Cardiovascular hospitalization was also associated with an increased risk of post-discharge death (adjusted HR 2.8, 95% CI 2.5-3.2, P < 0.0001), vascular death (adjusted HR 2.8, 95% CI 2.4-3.2, P < 0.0001), and sudden cardiac death (adjusted HR 2.1, 95% CI 1.6-2.7, P < 0.0001) compared with patients not hospitalized for any cardiovascular reason.
CONCLUSION
Hospitalizations are associated an increased risk of with death and cardiovascular death in patients with atrial fibrillation.",2019,"First hospitalization rates were 2312 (39.5%) for dabigatran etexilate (DE) 110, 2430 (41.6%) for DE 150, and 42.6% (N = 2458) for warfarin.","['Of the 18\u2009113 patients in RE-LY, 7200 (39.8%) were hospitalized at least once during a mean follow-up of 2\u2009years', 'patients with atrial fibrillation', 'patients with atrial fibrillation treated with']","['dabigatran or warfarin', 'warfarin']","['vascular death', 'First hospitalization rates', 'risk of post-discharge death', 'hospitalization and subsequent major adverse cardiac events', 'Cardiovascular hospitalization', 'risk of with death and cardiovascular death', 'sudden cardiac death', 'hospitalization and risk of mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0085298', 'cui_str': 'Sudden Cardiac Death'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",18113.0,0.33727,"First hospitalization rates were 2312 (39.5%) for dabigatran etexilate (DE) 110, 2430 (41.6%) for DE 150, and 42.6% (N = 2458) for warfarin.","[{'ForeName': 'Aiman', 'Initials': 'A', 'LastName': 'Alak', 'Affiliation': 'Department of Medicine, McMaster University, Population Health Research Institute (PHRI), 30 Birge St., Hamilton, Ontario, Canada.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Department of Cardiology, J.W. Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Fräßdorf', 'Affiliation': 'Boehringer Ingelheim GmbH & Co, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Reilly', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ezekowitz', 'Affiliation': 'Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Department of Medicine, McMaster University, Population Health Research Institute (PHRI), 30 Birge St., Hamilton, Ontario, Canada.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Faculty of Medicine, Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Department of Medicine, McMaster University, Population Health Research Institute (PHRI), 30 Birge St., Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Department of Medicine, McMaster University, Population Health Research Institute (PHRI), 30 Birge St., Hamilton, Ontario, Canada.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz021']
888,31502662,Selective Sebaceous Gland Electrothermolysis Using a Single Microneedle Radiofrequency Device for Acne Patients: A Prospective Randomized Controlled Study.,"BACKGROUND AND OBJECTIVES
The selective electrothermolysis of the sebaceous glands was suggested as a novel therapeutic option for facial acne. However, there has been no randomized controlled trial to evaluate the effectiveness and safety of the monopolar radiofrequency (RF) device using single microneedle with proximal insulation. The objective of the study was to evaluate the efficacy and tolerability of intralesional electrothermolysis using monopolar RF device and proximally-insulated single microneedle in acne patients.
STUDY DESIGN/MATERIALS AND METHODS
The prospective randomized controlled clinical trial was performed to treat moderate-to-severe facial acne. Subjects randomized to the treatment group received three treatments at 4-week intervals with an RF device, whereas the control group received micro-needling and extraction. For efficacy evaluation, reduction rate of acne lesions were evaluated by two independent physicians.
RESULTS
Sixty-three patients completed the study and the results showed statistically significant improvement of inflammatory acne at 12 weeks. The number of inflammatory lesions was significantly reduced at 12 weeks (20.86 vs. -5.13; P = 0.03) compared with controls.
CONCLUSIONS
Selective sebaceous gland electrothermolysis can be a safe and effective method of achieving consistent improvement in acne. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.",2020,"The number of inflammatory lesions was significantly reduced at 12 weeks (20.86 vs. -5.13; P = 0.03) compared with controls.
","['Acne Patients', '2019', 'acne patients', 'moderate-to-severe facial acne']","['Selective Sebaceous Gland Electrothermolysis Using a Single Microneedle Radiofrequency Device', 'intralesional electrothermolysis', 'control group received micro-needling and extraction', 'monopolar RF device and proximally-insulated single microneedle', 'monopolar radiofrequency (RF) device']","['number of inflammatory lesions', 'inflammatory acne', 'efficacy and tolerability', 'reduction rate of acne lesions']","[{'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0036505', 'cui_str': 'Sebaceous Glands'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C1998083', 'cui_str': 'Inflammatory acne'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",63.0,0.0501248,"The number of inflammatory lesions was significantly reduced at 12 weeks (20.86 vs. -5.13; P = 0.03) compared with controls.
","[{'ForeName': 'Ga Ram', 'Initials': 'GR', 'LastName': 'Ahn', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Min', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Su Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kapsok', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Beom Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}]",Lasers in surgery and medicine,['10.1002/lsm.23152']
889,31494273,Effects of Oxytocin on Placebo and Nocebo Effects in a Pain Conditioning Paradigm: A Randomized Controlled Trial.,"Oxytocin has been shown to increase trust, decrease anxiety, and affect learning as has been observed in conditioning paradigms. Trust, anxiety, and learning are important factors that influence placebo effects. In this study, we investigated whether oxytocin can increase placebo analgesia, decrease nocebo hyperalgesia, and influence extinction processes of both. Eighty male volunteers were assigned to a 40 IU of oxytocin nasal spray group, or to a placebo control group. Placebo analgesia and nocebo hyperalgesia were induced by a conditioning procedure in combination with verbal suggestions. The results demonstrate that the conditioning procedure successfully elicited significant placebo analgesia and nocebo hyperalgesia responses (P < .001). Furthermore, extinction was observed (P < .001), although placebo and nocebo responses did not return to baseline and remained significant. Oxytocin did not influence placebo analgesia or nocebo hyperalgesia and had no effect on extinction. This study provides support against the placebo-boosting effects of oxytocin and was the first one to demonstrate that it also did not influence nocebo effects or extinction processes, however, these results pertain to only a male sample. As managing placebo and nocebo effects has widespread clinical implications, further research should investigate other neurobiological or behavioral pathways to boost placebo and decrease nocebo effects. PERSPECTIVE: The present study demonstrated that placebo analgesia and nocebo hyperalgesia can be successfully induced by conditioning and verbal suggestions. We could not confirm the hypothesis that oxytocin affects either of these phenomena. Other pharmacological agents and behavioral manipulations for increasing placebo and decreasing nocebo effects should be investigated.",2020,"Furthermore, extinction was observed (p < .001), although placebo and nocebo responses did not return to baseline and remained significant.","['Eighty male volunteers', 'a pain conditioning paradigm']","['Placebo', 'oxytocin nasal spray', 'oxytocin', 'placebo', 'Oxytocin', 'placebo control group']","['placebo analgesia and nocebo hyperalgesia responses', 'nocebo hyperalgesia', 'extinction']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]",80.0,0.345239,"Furthermore, extinction was observed (p < .001), although placebo and nocebo responses did not return to baseline and remained significant.","[{'ForeName': 'Aleksandrina', 'Initials': 'A', 'LastName': 'Skvortsova', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, The Netherlands; Leiden Institute for Brain and Cognition, Leiden, The Netherlands. Electronic address: a.skvortsova@fsw.leidenuniv.nl.'}, {'ForeName': 'Dieuwke S', 'Initials': 'DS', 'LastName': 'Veldhuijzen', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, The Netherlands; Leiden Institute for Brain and Cognition, Leiden, The Netherlands.'}, {'ForeName': 'Henriët', 'Initials': 'H', 'LastName': 'van Middendorp', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, The Netherlands; Leiden Institute for Brain and Cognition, Leiden, The Netherlands.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain Translational Symptoms Science, School of Nursing and Department of Anaesthesiology, Medicine, University of Maryland Baltimore, Baltimore, Maryland.'}, {'ForeName': 'Andrea W M', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, The Netherlands; Leiden Institute for Brain and Cognition, Leiden, The Netherlands; Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.08.010']
890,31494275,Therapy Habituation at 12 Months: Spinal Cord Stimulation Versus Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome Type I and II.,"The ACCURATE randomized, controlled trial compared outcomes of dorsal root ganglion (DRG) stimulation versus tonic spinal cord stimulation (SCS) in 152 subjects with chronic lower extremity pain due to complex regional pain syndrome (CRPS) type I or II. This ACCURATE substudy was designed to evaluate whether therapy habituation occurs with DRG stimulation as compared to SCS through 12-months. A modified intention-to-treat analysis was performed to assess percentage pain relief (PPR) and responder rates at follow-up visits (end-of-trial, 1, 3, 6, 9, 12-months postpermanent implant) for all subjects that completed trial stimulation (DRG:N = 73, SCS:N = 72). For both groups, mean PPR was significantly greater at end-of-trial (DRG = 82.2%, SCS =0 77.0%) than all other follow-ups. Following permanent DRG system implantation, none of the time points were significantly different from one another in PPR (range = 69.3-73.9%). For the SCS group, PPR at 9-months (58.3%) and 12-months (57.9%) was significantly less than at 1-month (66.9%). The responder rate also decreased for the SCS group from 1-month (68.1%) to 12-months (61.1%). After stratifying by diagnosis, it was found that only the CRPS-I population had diminishing pain relief with SCS. DRG stimulation resulted in more stable pain relief through 12-months, while tonic SCS demonstrated therapy habituation at 9- and 12-months. Trial Registration: The ACCURATE study was registered at ClinicalTrials.gov with Identifier NCT01923285. PERSPECTIVE: This article reports on an ACCURATE substudy, which found that long-term therapy habituation occurred at 12-months with SCS, but not DRG stimulation, in patients with CRPS. The underlying mechanisms of action for these results remain unclear, although several lines of inquiry are proposed.",2020,"For the SCS group, PPR at 9-months (58.3%) and 12-months (57.9%) was significantly less than at 1-month (66.9%).","['152 subjects with chronic lower extremity pain due to complex regional pain syndrome (CRPS) type I or II', 'patients with CRPS']","['dorsal root ganglion (DRG) stimulation versus tonic spinal cord stimulation (SCS', 'DRG stimulation', 'Spinal Cord Stimulation Versus Dorsal Root Ganglion Stimulation']","['percentage pain relief (PPR) and responder rates', 'Complex Regional Pain', 'therapy habituation', 'mean PPR', 'responder rate', 'stable pain relief', 'pain relief with SCS']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0034931', 'cui_str': 'CRPS Type I'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0017070', 'cui_str': 'Dorsal Root Ganglia'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0394477', 'cui_str': 'Spinal Cord Stimulation'}, {'cui': 'C0011928', 'cui_str': 'DRG'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]",152.0,0.0632925,"For the SCS group, PPR at 9-months (58.3%) and 12-months (57.9%) was significantly less than at 1-month (66.9%).","[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Levy', 'Affiliation': 'Marcus Neuroscience Institute, Boca Raton, Florida.'}, {'ForeName': 'Nagy', 'Initials': 'N', 'LastName': 'Mekhail', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kramer', 'Affiliation': 'Volta Research and University of Illinois College of Medicine, Chicago, Illinois.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Poree', 'Affiliation': 'University of California at San Francisco, California.'}, {'ForeName': 'Kasra', 'Initials': 'K', 'LastName': 'Amirdelfan', 'Affiliation': 'IPM Medical Group, Inc., Walnut Creek, California.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Grigsby', 'Affiliation': 'Neurovations, Napa, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Staats', 'Affiliation': 'Premier Pain Center, Shrewsbury Township, New Jersey.'}, {'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Burton', 'Affiliation': 'Abbott Neuromodulation, Plano, Texas.'}, {'ForeName': 'Abram H', 'Initials': 'AH', 'LastName': 'Burgher', 'Affiliation': 'HOPE Research - TPC, Phoenix, Arizona.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Scowcroft', 'Affiliation': 'Pain Management Associates, Independence, Missouri.'}, {'ForeName': 'Stan', 'Initials': 'S', 'LastName': 'Golovac', 'Affiliation': 'Florida Pain, Merritt Island, Florida.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Kapural', 'Affiliation': 'Carolinas Pain Institute, Winston-Salem, North Carolina.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Paicius', 'Affiliation': 'Newport Beach Headache and Pain, Newport Beach, California.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Pope', 'Affiliation': 'Evolve Restorative Center, Santa Rosa, California.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Samuel', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'William Porter', 'Initials': 'WP', 'LastName': 'McRoberts', 'Affiliation': 'Holy Cross Hospital, Ft. Lauderdale, Florida.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schaufele', 'Affiliation': 'Drug Studies America, Marietta, Georgia.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Kent', 'Affiliation': 'Abbott Neuromodulation, Plano, Texas. Electronic address: alex.kent@abbott.com.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Raza', 'Affiliation': 'Abbott Neuromodulation, Plano, Texas.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Deer', 'Affiliation': 'Spine and Nerve Center of the Virginias, Charleston, West Virginia.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.08.005']
891,15243316,Effect of an oral bulking agent and a rectal laxative administered alone or in combination for the treatment of constipation.,"OBJECTIVES
The aim of the present study was to search for a synergetic action between psyllium and a defecation-inducing drug, Eductyl, for symptom relief in patients suffering from chronic constipation.
METHODS
Twenty healthy volunteers and 20 patients complaining of chronic constipation were included in a randomized crossover study. The study was divided into four 2-weeks periods: pre-inclusion and three periods of treatment with psyllium, Eductyl, and Eductyl + psyllium respectively. Colonic transit time was determined at the end of each period of treatment. During each of the four periods, a self-administered questionnaire was used to assess symptoms of constipation.
RESULTS
For constipated patients, treatment with Eductyl and Eductyl-psyllium improved clinical symptoms of constipation: increased stool frequency, resulted in fewer hard stools and less sensation of incomplete evacuation and less straining to defecate. The improvement was associated with a decrease in total and segmental colonic transit time. The Eductyl-psyllium combination did not exhibit any synergetic effect.
CONCLUSION
Treatment with Eductyl alone is more efficient than with psyllium alone in providing symptom relief. Combination with psyllium is not synergetic.",2004,"treatment with Eductyl and Eductyl-psyllium improved clinical symptoms of constipation: increased stool frequency, resulted in fewer hard stools and less sensation of incomplete evacuation and less straining to defecate.","['patients suffering from chronic constipation', 'Twenty healthy volunteers and 20 patients complaining of chronic constipation']","['Eductyl and Eductyl-psyllium', 'oral bulking agent and a rectal laxative administered alone or in combination']","['total and segmental colonic transit time', 'stool frequency', 'Colonic transit time', 'symptoms of constipation', 'clinical symptoms of constipation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation (disorder)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0033979', 'cui_str': 'Psyllium'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",20.0,0.0212342,"treatment with Eductyl and Eductyl-psyllium improved clinical symptoms of constipation: increased stool frequency, resulted in fewer hard stools and less sensation of incomplete evacuation and less straining to defecate.","[{'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Bouchoucha', 'Affiliation': 'Hôpital Broussais, Laboratoire de physiologie digestive, 96, rue Didot 75014 Paris. michel.bouchoucha@brs.ap-hop-paris.fr'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Faye', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Savarieau', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Arsac', 'Affiliation': ''}]",Gastroenterologie clinique et biologique,[]
892,31831868,Effect of a Dual PPAR α/γ agonist on Insulin Sensitivity in Patients of Type 2 Diabetes with Hypertriglyceridemia- Randomized double-blind placebo-controlled trial.,"Saroglitazar is a dual PPAR-α/γ agonist approved for the treatment of diabetic dyslipidemia. In addition to reduction in atherogenic lipids, it may also contribute to improvement in insulin sensitivity through PPAR-α/γ agonism, which remains unexplored. We conducted a randomized, double-blind, placebo-controlled trial in treatment-naive T2DM individuals with serum triglyceride >150 mg/dL. Participants were randomized to receive either saroglitazar 4 mg or placebo (1:1) daily for 4 months (n = 30). Insulin sensitivity (SI clamp ) was studied using hyperinsulinemic-euglycemic clamp at baseline and at 4 months. We observed a significant reduction in TG (p = 0.001), HbA1c (p = 0.019) and fasting plasma glucose (p = 0.019) and significant increase in HDL-C levels (p < 0.01) with saroglitazar compared to placebo. Further, patients on saroglitazar had a greater improvement in SI clamp (p = 0.026) with the effect persisting despite adjusting for baseline weight, TG, HDL-C and HbA1c (p = 0.002). This was accompanied with significant increase in HOMA-β (p = 0.01) in the saroglitazar group and change in HOMA-β showed a trend towards significance with SI clamp (r = 0.503, p = 0.056). However, change in SI clamp did not significantly correlate with reduction in HbA1c and TG. We conclude that saroglitazar effectively reduces hypertriglyceridemia and improves insulin sensitivity along with β-cell function by reduction in gluco-lipotoxicity and possibly directly through PPAR-γ agonism in patients ofT2DM with hypertriglyceridemia.",2019,"We observed a significant reduction in TG (p = 0.001), HbA1c (p = 0.019) and fasting plasma glucose (p = 0.019) and significant increase in HDL-C levels (p < 0.01) with saroglitazar compared to placebo.","['Patients of Type 2 Diabetes with Hypertriglyceridemia', 'treatment-naive T2DM\xa0individuals with serum triglyceride\u2009>150\u2009mg/dL. Participants']","['Dual PPAR α/γ agonist', 'saroglitazar 4\u2009mg or placebo', 'placebo']","['hypertriglyceridemia and improves insulin sensitivity', 'atherogenic lipids', 'TG', 'fasting plasma glucose', 'HOMA-β', 'HbA1c and TG', 'Insulin Sensitivity', 'SI clamp', 'Insulin sensitivity (SI clamp ', 'HDL-C levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0166418', 'cui_str': 'Peroxisome Proliferator-Activated Receptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3852920'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.425016,"We observed a significant reduction in TG (p = 0.001), HbA1c (p = 0.019) and fasting plasma glucose (p = 0.019) and significant increase in HDL-C levels (p < 0.01) with saroglitazar compared to placebo.","[{'ForeName': 'Nimisha', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Department of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}, {'ForeName': 'Shobhit', 'Initials': 'S', 'LastName': 'Bhansali', 'Affiliation': 'Diabetes Research and Training Center and Division of Endocrinology, Department of Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Anura V', 'Initials': 'AV', 'LastName': 'Kurpad', 'Affiliation': ""Department of Physiology, St. John's Medical College, Bengaluru, India.""}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Hawkins', 'Affiliation': 'Diabetes Research and Training Center and Division of Endocrinology, Department of Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Akhilesh', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Psychiatry, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Department of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}, {'ForeName': 'Ashu', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012, India. ashuendo@gmail.com.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Bhansali', 'Affiliation': 'Department of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012, India. anilbhansaliendocrine@gmail.com.'}]",Scientific reports,['10.1038/s41598-019-55466-3']
893,31831801,"A randomised clinical trial to evaluate the safety, fit, comfort of a novel N95 mask in children.","Children are more vulnerable to the risks of air pollution, including susceptibility to acquiring chronic diseases in their developing lungs. Despite these, there are no specific masks designed for and tested in children that are available to protect our young from the common particulate air pollutants today. We evaluated safety, fit and comfort of a specially designed paediatric N95 mask with an optional micro ventilator (micro fan, MF) in healthy children aged 7-14 years, in a randomized, two-period crossover design. The subjects' cardiorespiratory physiological measurements were assessed in different states of physical activity under different interventions (mask without and with MF). A total of 106 subjects were recruited between July-August 2016. The use of the mask without MF increased the End-Tidal CO 2 (ETCO 2 ) and Fractional concentration of Inspired CO 2 (FICO 2 ) at rest and on mild exertion, as expected. The use of the mask with MF brought FICO 2 levels comparably closer to baseline levels without the mask for both activities. The mask, with or without the MF, was found to be well fitting, comfortable and safe for use in children at rest and on mild exertion. The N95 mask tested offers a promising start for more studies in the paediatric population.",2019,"The mask, with or without the MF, was found to be well fitting, comfortable and safe for use in children at rest and on mild exertion.","['healthy children aged 7-14 years', 'children', 'A total of 106 subjects were recruited between July-August 2016']","['paediatric N95 mask with an optional micro ventilator (micro fan, MF']",['End-Tidal CO 2 (ETCO 2 ) and Fractional concentration of Inspired CO 2 (FICO 2 ) at rest and on mild exertion'],"[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0429406', 'cui_str': 'Pattern ERG N95'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0441039', 'cui_str': 'Fan (physical object)'}]","[{'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}]",106.0,0.0405321,"The mask, with or without the MF, was found to be well fitting, comfortable and safe for use in children at rest and on mild exertion.","[{'ForeName': 'Daniel Yam Thiam', 'Initials': 'DYT', 'LastName': 'Goh', 'Affiliation': 'Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore. daniel_goh@nuhs.edu.sg.'}, {'ForeName': 'Meng Wai', 'Initials': 'MW', 'LastName': 'Mun', 'Affiliation': 'Innosparks Pte Ltd, Singapore, Singapore.'}, {'ForeName': 'Wei Liang Jerome', 'Initials': 'WLJ', 'LastName': 'Lee', 'Affiliation': 'Innosparks Pte Ltd, Singapore, Singapore.'}, {'ForeName': 'Oon Hoe', 'Initials': 'OH', 'LastName': 'Teoh', 'Affiliation': ""Department of Paediatrics, KK Women's and Children's Hospital, Singapore, Singapore.""}, {'ForeName': 'Dimple D', 'Initials': 'DD', 'LastName': 'Rajgor', 'Affiliation': 'Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}]",Scientific reports,['10.1038/s41598-019-55451-w']
894,31831865,Safety and efficacy of risedronate for patients with esophageal varices and liver cirrhosis: a non-randomized clinical trial.,"Despite the high prevalence of osteoporosis in liver cirrhosis, the indication of bisphosphonates for patients with esophageal varices has been avoided due to risk of digestive mucosal damage. Therefore, this study aimed to evaluate the safety profile of risedronate treatment for patients with osteoporosis, liver cirrhosis and esophageal varices with low risk of bleeding. A total of 120 patients were allocated into two groups according to their bone mineral density measured by dual-energy X-ray absorptiometry. In the intervention group, 57 subjects with osteoporosis received oral risedronate at 35 mg weekly plus daily calcium and vitamin D supplementation. In the control group, 63 subjects with osteopenia received only calcium and vitamin D. The groups received the treatment for one year and underwent surveillance endoscopies at six and 12 months, as well as a control dual-energy X-ray absorptiometry after a 12-month follow-up. The study received Institutional Review Board approval. The groups had not only comparable Model for End-stage Liver Disease score and esophageal varices degree, but also similar incidence of digestive adverse effects. A significant improvement was achieved in the intervention group in the lumbar spine T score (p < 0.001). The results suggest that risedronate may be safely used in liver cirrhosis and esophageal varices with low bleeding risk under endoscopic surveillance, thus allowing bone mass recovery.",2019,A significant improvement was achieved in the intervention group in the lumbar spine T score (p < 0.001).,"['patients with esophageal varices and liver cirrhosis', 'patients with esophageal varices', 'A total of 120 patients', 'patients with osteoporosis, liver cirrhosis and esophageal varices with low risk of bleeding', '57 subjects with osteoporosis received', '63 subjects with osteopenia received only', 'liver cirrhosis and esophageal varices with low bleeding risk under endoscopic surveillance']","['oral risedronate at 35\u2009mg weekly plus daily calcium and vitamin D supplementation', 'calcium and vitamin D', 'risedronate']","['Safety and efficacy', 'Model for End-stage Liver Disease score and esophageal varices degree', 'lumbar spine T score', 'digestive adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014867', 'cui_str': 'Esophageal Varices'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4048785', 'cui_str': 'MELD score'}, {'cui': 'C0014867', 'cui_str': 'Esophageal Varices'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",63.0,0.0374779,A significant improvement was achieved in the intervention group in the lumbar spine T score (p < 0.001).,"[{'ForeName': 'Talles Bazeia', 'Initials': 'TB', 'LastName': 'Lima', 'Affiliation': 'Internal Medicine Department, Gastroenterology Division - São Paulo State University (UNESP), Botucatu Medical School, São Paulo, Brazil.'}, {'ForeName': 'Lívia Alves Amaral', 'Initials': 'LAA', 'LastName': 'Santos', 'Affiliation': 'Internal Medicine Department, Gastroenterology Division - São Paulo State University (UNESP), Botucatu Medical School, São Paulo, Brazil.'}, {'ForeName': 'Hélio Rubens de Carvalho', 'Initials': 'HRC', 'LastName': 'Nunes', 'Affiliation': 'Public Health Department, São Paulo State University (UNESP), Botucatu Medical School, São Paulo, Brazil.'}, {'ForeName': 'Giovanni Faria', 'Initials': 'GF', 'LastName': 'Silva', 'Affiliation': 'Internal Medicine Department, Gastroenterology Division - São Paulo State University (UNESP), Botucatu Medical School, São Paulo, Brazil.'}, {'ForeName': 'Carlos Antonio', 'Initials': 'CA', 'LastName': 'Caramori', 'Affiliation': 'Internal Medicine Department, Gastroenterology Division - São Paulo State University (UNESP), Botucatu Medical School, São Paulo, Brazil.'}, {'ForeName': 'Xingshun', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'General Hospital of Shenyang Military Command, Liaoning, Sheng, China.'}, {'ForeName': 'Fernando Gomes', 'Initials': 'FG', 'LastName': 'Romeiro', 'Affiliation': 'Internal Medicine Department, Gastroenterology Division - São Paulo State University (UNESP), Botucatu Medical School, São Paulo, Brazil. fernando.romeiro@unesp.br.'}]",Scientific reports,['10.1038/s41598-019-55603-y']
895,32069516,Effect of postdose fasting duration on hetrombopag olamine pharmacokinetics and pharmacodynamics in healthy volunteers.,"AIMS
Hetrombopag olamine is a novel small-molecule, nonpeptide thrombopoietin receptor agonist developed for immune thrombocytopenia treatment. This study aims to determine the safety and the effect of fasting duration after administration of hetrombopag on pharmacokinetics and pharmacodynamics in Chinese healthy subjects.
METHODS
A randomized, open-label, single-dose, 3-period crossover, self-control trial was conducted. 15 eligible subjects were enrolled and received hetrombopag 7.5 mg at day 1 of each period followed by a standard meal 4 hours postdose (treatment A/fasting condition), or a high-calorie, high-fat meal 1 hour postdose (treatment B), or a high-calorie, high-fat meal 2 hours postdose (treatment C). The plasma concentrations of hetrombopag were determined by validated liquid chromatography-tandem mass spectrometry, platelet counts were quantified by blood test. Analysis was performed using a mixed model, including treatment, period as fixed effects and participant as a random effect.
RESULTS
Compared with treatment A, peak concentration and area under concentration-time curve extrapolated to infinity decreased by 56 and 74.6%, and 44 and 61% in treatments B and C, respectively. The mean platelet number on day 6 increased by 15.8, 6.96 and 10.26%, respectively, in treatments A, B and C in comparison with baseline platelet level. No severe adverse events happened in any of the 3 treatments.
CONCLUSION
Hetrombopag was well tolerated in healthy male subjects under fasted/fed conditions. The shorter fasting duration resulted in lower hetrombopag exposure, corresponding to a lower level of platelet elevation. Therefore, we recommended oral administration of hetrombopag on an empty stomach (fasting condition) or at least 2 hours before a meal to achieve maximum bioavailability.",2020,"The mean platelet number on day 6 increase by 15.8%, 6.96% and 10.26% respectively in treatment A, B and C in comparison with baseline platelet level.","['Chinese healthy subjects', 'healthy male subjects', '15 eligible subjects', 'Healthy Volunteers']","['hetrombopag', 'hetrombopag 7.5 mg at day 1 of each period followed by a standard meal 4 h post-dose (treatment A/fasting condition), or a high-calorie, high-fat meals 1 h post-dose (treatment B), or a high-calorie, high-fat meals 2 h post-dose (treatment C', 'Post-dose Fasting Duration']","['plasma concentrations of hetrombopag', 'severe adverse events', 'shorter fasting duration', 'mean platelet number', 'C max and AUC 0-∞']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C4505753', 'cui_str': '5-(3-(2-(1-(bicyclo(4.2.0)octa-1,3,5-trien-3-yl)-3-methyl-5-oxo-1H-pyrazol-4(5H)-ylidene)hydrazinyl)-2-hydroxyphenyl)furan-2-carboxylic acid'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0444664', 'cui_str': 'Standard meal (finding)'}, {'cui': 'C0439568', 'cui_str': 'Post-dose (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4505753', 'cui_str': '5-(3-(2-(1-(bicyclo(4.2.0)octa-1,3,5-trien-3-yl)-3-methyl-5-oxo-1H-pyrazol-4(5H)-ylidene)hydrazinyl)-2-hydroxyphenyl)furan-2-carboxylic acid'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032181', 'cui_str': 'Blood Platelet Number'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",15.0,0.0406373,"The mean platelet number on day 6 increase by 15.8%, 6.96% and 10.26% respectively in treatment A, B and C in comparison with baseline platelet level.","[{'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan China.'}, {'ForeName': 'Ranglang', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan China.'}, {'ForeName': 'Xingfei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan China.'}, {'ForeName': 'Honghui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan China.'}, {'ForeName': 'Chengxian', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan China.'}, {'ForeName': 'Yanfei', 'Initials': 'Y', 'LastName': 'Tai', 'Affiliation': 'Department of Clinical Research, Jiangsu Hengrui Medicine Co., LTD., Shanghai, China.'}, {'ForeName': 'Yancong', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Clinical Research, Jiangsu Hengrui Medicine Co., LTD., Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan China.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Zou', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan China.'}]",British journal of clinical pharmacology,['10.1111/bcp.14259']
896,31493287,Extended prophylaxis of venous thromboembolism with betrixaban in acutely ill medical patients with and without cancer: insights from the APEX trial.,"Acutely ill medical patients with cancer are at increased risk of venous thromboembolism (VTE). Thromboprophylaxis is recommended in the presence of cancer, but its safety is not known. The aim of this study was to assess the efficacy and safety of extended prophylaxis with betrixaban in cancer patients enrolled in the APEX trial. APEX was a randomized, double-blind trial comparing oral betrixaban 80 mg qd administered for 35-42 days with subcutaneous enoxaparin 40 mg qd administered for 10 ± 4 days. Patients with acute medical illness and a history of cancer or active cancer were eligible for inclusion. Primary efficacy outcome was VTE (composite of symptomatic VTE and asymptomatic proximal deep vein thrombosis); primary safety outcome was major bleeding. Of 7513 patients enrolled in the APEX trial, 959 patients (12.8%), 499 randomized to betrixaban and 460 to enoxaparin, had cancer. The primary efficacy outcome occurred in 5.7% of cancer patients treated with betrixaban and in 6.2% treated with enoxaparin (p = 0.95). No significant interaction according to the presence or absence of cancer was observed (p = 0.36). Major bleeding events occurred in 0.8% of patients in the betrixaban group and in 0% in the enoxaparin group (p = 0.13), with no significant interaction (p = 0.07). The composite of major and clinically relevant non-major bleeds was similar between the two groups (2.9% and 2.0%, respectively, RR 1.43, 95% CI 0.63-3.27). Betrixaban was similarly effective in the reduction of VTE among subjects with and without cancer. The incidence of major bleeding was similarly low.",2020,"Major bleeding events occurred in 0.8% of patients in the betrixaban group and in 0% in the enoxaparin group (p = 0.13), with no significant interaction (p = 0.07).","['7513 patients enrolled in the APEX trial, 959 patients (12.8%), 499 randomized to betrixaban and 460 to enoxaparin, had cancer', 'Patients with acute medical illness and a history of cancer or active cancer were eligible for inclusion', 'cancer patients enrolled in the APEX trial', 'subjects with and without cancer', 'Acutely ill medical patients with cancer', 'acutely ill medical patients with and without cancer']","['subcutaneous enoxaparin', 'Thromboprophylaxis', 'enoxaparin', 'betrixaban', 'Betrixaban', 'oral betrixaban']","['VTE (composite of symptomatic VTE and asymptomatic proximal deep vein thrombosis); primary safety outcome was major bleeding', 'presence or absence of cancer', 'composite of major and clinically relevant non-major bleeds', 'risk of venous thromboembolism (VTE', 'efficacy and safety', 'Major bleeding events', 'incidence of major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C2698385', 'cui_str': 'betrixaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0455471', 'cui_str': 'H/O: malignant neoplasm'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C2698385', 'cui_str': 'betrixaban'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",499.0,0.165677,"Major bleeding events occurred in 0.8% of patients in the betrixaban group and in 0% in the enoxaparin group (p = 0.13), with no significant interaction (p = 0.07).","[{'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ageno', 'Affiliation': 'Department of Medicine and Surgery, University of Insubria, via Guicciardini 9, 21100, Varese, Italy. walter.ageno@uninsubria.it.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke University and Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Megan K', 'Initials': 'MK', 'LastName': 'Yee', 'Affiliation': 'Boston Clinical Research Institute, Newton, MA, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hernandez', 'Affiliation': 'Duke University and Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Hull', 'Affiliation': 'Division of Cardiology, R.A.H Faculty of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Division of Cardiovascular Medicine, Harvard Medical School, Brigham and Women's Hospital, Boston, USA.""}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Boston Clinical Research Institute, Newton, MA, USA.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Cohen', 'Affiliation': ""Department of Haematological Medicine, Guy's and St Thomas' Hospitals, London, UK.""}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-019-01943-5']
897,31473510,Temporal changes in postprandial blood transcriptomes reveal subject-specific pattern of expression of innate immunity genes after a high-fat meal.,"White blood cells are among the first responders to dietary components and their metabolites absorbed from the gut. The objective of this study was to determine the whole blood transcriptome response to high-fat challenge meals. A total of 45 fasting and postprandial (3-h and 6-h) whole blood transcriptomes from 5 subjects in a crossover intervention trial of a high-fat meal supplemented with placebo, blueberry powder or docosahexaenoic acid (DHA) were analyzed using RNA sequencing. Select target genes were validated by quantitative reverse-transcription polymerase chain reaction in 180 samples from 20 subjects. The largest contributor to variance was the subject (13,856 genes differentially expressed), followed by the subject on a specific day (2276 genes), followed by the subject's postprandial response (651 genes). After determining the nonsignificance of individual dietary treatments (blueberry, DHA, placebo), treatments were used as replicates to examine postprandial responses to a high-fat meal. The universal postprandial response (95 genes) was associated with lipid utilization, fatty acid beta-oxidation and circadian rhythms. Subject-specific postprandial responses were enriched for genes involved in the innate immune response, particularly those of pattern recognition receptors and their downstream signaling components. Genes involved in innate immune responses are differentially expressed in a subject-specific and time-dependent manner in response to the high-fat meals. These genes can serve as biomarkers to assess individual responsiveness to a high-fat diet in inducing postprandial inflammation. Furthermore, the dynamic temporal change in gene expression in postprandial blood suggests that monitoring these genes at multiple time points is necessary to reveal responders to dietary intervention.",2019,"Subject-specific postprandial responses were enriched for genes involved in the innate immune response, particularly those of pattern recognition receptors and their downstream signaling components.",[],"['45 fasting and postprandial (3-h and 6-h) whole blood transcriptomes', 'placebo, blueberry powder or docosahexaenoic acid (DHA', 'individual dietary treatments (blueberry, DHA, placebo']","['lipid utilization, fatty acid beta-oxidation and circadian rhythms', 'universal postprandial response']",[],"[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}, {'cui': 'C3178810', 'cui_str': 'Transcriptome'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0950037', 'cui_str': 'Blueberries'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0008810', 'cui_str': 'Nycthemeral Rhythm'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}]",,0.0144234,"Subject-specific postprandial responses were enriched for genes involved in the innate immune response, particularly those of pattern recognition receptors and their downstream signaling components.","[{'ForeName': 'Danielle G', 'Initials': 'DG', 'LastName': 'Lemay', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616; Department of Nutrition, University of California-Davis, One Shields Avenue, Davis, CA, 95616; Genome Center, University of California-Davis, 451 Health Sciences Dr., Davis, CA 95616. Electronic address: Danielle.Lemay@usda.gov.'}, {'ForeName': 'Shurong', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616. Electronic address: Shurong.Huang@usda.gov.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616; Department of Nutrition, University of California-Davis, One Shields Avenue, Davis, CA, 95616. Electronic address: Liping.Huang@usda.gov.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Alkan', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616. Electronic address: Zeynep.Alkan@usda.gov.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kirschke', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616. Electronic address: Catherine.Kirschke@usda.gov.'}, {'ForeName': 'Dustin J', 'Initials': 'DJ', 'LastName': 'Burnett', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616; Department of Nutrition, University of California-Davis, One Shields Avenue, Davis, CA, 95616. Electronic address: Dustin.Burnett@usda.gov.'}, {'ForeName': 'Yining E', 'Initials': 'YE', 'LastName': 'Wang', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616. Electronic address: yewang@ucdavis.edu.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Hwang', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616; Department of Nutrition, University of California-Davis, One Shields Avenue, Davis, CA, 95616. Electronic address: dhhwang@ucdavis.edu.'}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2019.06.007']
898,31462766,Reward related ventral striatal activity and differential response to sertraline versus placebo in depressed individuals.,"Medications to treat major depressive disorder (MDD) are not equally effective across patients. Given that neural response to rewards is altered in MDD and given that reward-related circuitry is modulated by dopamine and serotonin, we examined, for the first time, whether reward-related neural activity moderated response to sertraline, an antidepressant medication that targets these neurotransmitters. A total of 222 unmedicated adults with MDD randomized to receive sertraline (n = 110) or placebo (n = 112) in the Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study completed demographic and clinical assessments, and pretreatment functional magnetic resonance imaging while performing a reward task. We tested whether an index of reward system function in the ventral striatum (VS), a key reward circuitry region, moderated differential response to sertraline versus placebo, assessed with the Hamilton Rating Scale for Depression (HSRD) over 8 weeks. We observed a significant moderation effect of the reward index, reflecting the temporal dynamics of VS activity, on week-8 depression levels (Fs ≥ 9.67, ps ≤ 0.002). Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms. Thus, a more abnormal pattern of pretreatment VS dynamic response to reward expectancy (expected outcome value) and prediction error (difference between expected and actual outcome), likely reflecting serotonergic and dopaminergic deficits, was associated with better response to sertraline than placebo. Pretreatment measures of reward-related VS activity may serve as objective neural markers to advance efforts to personalize interventions by guiding individual-level choice of antidepressant treatment.",2020,"Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms.","['depressed individuals', '222 unmedicated adults with MDD randomized to receive']","['placebo (n\u2009=\u2009112) in the Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study completed demographic and clinical assessments, and pretreatment functional magnetic resonance imaging while performing a reward task', 'sertraline', 'placebo', 'sertraline versus placebo']","['Hamilton Rating Scale for Depression (HSRD', 'depression symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",222.0,0.129786,"Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms.","[{'ForeName': 'Tsafrir', 'Initials': 'T', 'LastName': 'Greenberg', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA. greenbergt@upmc.edu.'}, {'ForeName': 'Jay C', 'Initials': 'JC', 'LastName': 'Fournier', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Richelle', 'Initials': 'R', 'LastName': 'Stiffler', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Chase', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Almeida', 'Affiliation': 'Department of Psychiatry, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Aslam', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Marisa S', 'Initials': 'MS', 'LastName': 'Toups', 'Affiliation': 'Department of Psychiatry, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Carmody', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Benji', 'Initials': 'B', 'LastName': 'Kurian', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Peltier', 'Affiliation': 'Functional MRI Laboratory, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Oquendo', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Parsey', 'Affiliation': 'Departments of Psychiatry and Behavioral Science & Radiology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Weissman', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Madhukar', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Molecular psychiatry,['10.1038/s41380-019-0490-5']
899,31474116,Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus.,"BACKGROUND
Patients with type 2 diabetes mellitus (T2DM) are at increased risk of developing heart failure. Sodium-glucose cotransporter-2 inhibitors reduce the risk of hospitalization for heart failure (HHF) in patients with T2DM. We aimed to develop and validate a practical clinical risk score for HHF in patients with T2DM and assess whether this score can identify high-risk patients with T2DM who have the greatest reduction in risk for HHF with a sodium-glucose cotransporter-2 inhibitor.
METHODS
We developed a clinical risk score for HHF in 8212 patients with T2DM in the placebo arm of SAVOR-TIMI 53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients With Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53). Candidate variables were assessed using multivariable Cox regression, and independent clinical risk indicators achieving statistical significance of P <0.001 were included in the risk score. We externally validated the score in 8578 patients with T2DM in the placebo arm of DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58). The relative and absolute risk reductions in HHF with the sodium-glucose cotransporter-2 inhibitor dapagliflozin were assessed by baseline HHF risk.
RESULTS
Five clinical variables were independent risk predictors of HHF: prior heart failure, history of atrial fibrillation, coronary artery disease, estimated glomerular filtration rate, and urine albumin-to-creatinine ratio. A simple integer-based score (0-7 points) using these predictors identified a >20-fold gradient of HHF risk ( P for trend <0.001) in both the derivation and validation cohorts, with C indices of 0.81 and 0.78, respectively. Although relative risk reductions with dapagliflozin were similar for patients across the risk scores (25%-34%), absolute risk reductions were greater in those at higher baseline risk (1-sided P for trend=0.04), with high-risk (2 points) and very-high-risk (≥3 points) patients having 1.5% and 2.7% absolute reductions in Kaplan-Meier estimates of HHF risk at 4 years, respectively.
CONCLUSIONS
Risk stratification using a novel clinical risk score for HHF in patients with T2DM identifies patients at higher risk for HHF who derive greater absolute benefit from sodium-glucose cotransporter-2 inhibition.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01107886 and NCT01730534.",2019,"Although relative risk reductions with dapagliflozin were similar for patients across the risk scores (25%-34%), absolute risk reductions were greater in those at higher baseline risk (1-sided P for trend=0.04), with high-risk (2 points) and very-high-risk (≥3 points) patients having 1.5% and 2.7% absolute reductions in Kaplan-Meier estimates of HHF risk at 4 years, respectively.
","['Patients', 'patients with T2DM', '8578 patients with T2DM in the placebo arm of DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58', 'risk patients with T2DM who have the greatest reduction in risk for HHF with a sodium-glucose cotransporter-2 inhibitor', 'Patients With Type 2 Diabetes Mellitus', 'Patients with type 2 diabetes mellitus (T2DM', '8212 patients with T2DM in the placebo arm of SAVOR-TIMI 53']","['dapagliflozin', 'Sodium-Glucose Cotransporter-2 Inhibitors', 'Saxagliptin', 'Sodium-glucose cotransporter-2 inhibitors']","['HHF: prior heart failure, history of atrial fibrillation, coronary artery disease, estimated glomerular filtration rate, and urine albumin-to-creatinine ratio', 'risk of hospitalization for heart failure (HHF', 'absolute risk reductions', 'HHF risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}]","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0729790', 'cui_str': 'H/O: atrial fibrillation'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C3811844'}, {'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",,0.0836097,"Although relative risk reductions with dapagliflozin were similar for patients across the risk scores (25%-34%), absolute risk reductions were greater in those at higher baseline risk (1-sided P for trend=0.04), with high-risk (2 points) and very-high-risk (≥3 points) patients having 1.5% and 2.7% absolute reductions in Kaplan-Meier estimates of HHF risk at 4 years, respectively.
","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Berg', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Hadassah Hebrew University Hospital, Jerusalem, Israel (O.M., I.R.).'}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Canada (L.A.L.).""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas (D.K.M.).'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'University of Liverpool, United Kingdom (J.P.H.W.).'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden (P.J., P.A.J., A.M.L.).'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Johansson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden (P.J., P.A.J., A.M.L.).'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden (P.J., P.A.J., A.M.L.).'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Hadassah Hebrew University Hospital, Jerusalem, Israel (O.M., I.R.).'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}]",Circulation,['10.1161/CIRCULATIONAHA.119.042685']
900,31489717,Cardiovascular disease risk among rural residents living with diabetes and prediabetes: A cluster randomized trial.,"OBJECTIVE
Diabetes is a major health problem that is closely linked with cardiovascular disease (CVD), the leading cause of death in the United States. The purpose of this analysis was to determine the effect of a culturally relevant diabetes health promotion program on diabetes knowledge and self-reported self-care behaviors.
DESIGN
A cluster randomized controlled trial was conducted in 12 rural church settings. Seven churches were randomized to the intervention group and five to the control group.
SAMPLE
The sample included 146 African American participants diagnosed with diabetes and prediabetes.
INTERVENTION
The intervention group participants (n = 75) received the diabetes health program, and those in the control group (n = 71) group received a publicly available diabetes health brochure.
MEASURES
Data were collected about diabetes knowledge, self-care activities, fatalism, and social support.
RESULTS
Linear mixed model was the statistical test used to analyze group differences. Compared with the control group, the intervention group showed significant changes from pretest to posttest for diabetes knowledge and behaviors associated with diet and blood glucose testing.
CONCLUSION
Health promotion programs implemented by public health nurses among rural groups at increased risk for developing CVD can facilitate understanding about strategies to reduce disease risk.",2020,"Compared with the control group, the intervention group showed significant changes from pretest to posttest for diabetes knowledge and behaviors associated with diet and blood glucose testing.
","['12 rural church settings', 'rural residents living with diabetes and prediabetes', '146 African American participants diagnosed with diabetes and prediabetes', 'Seven churches']","['culturally relevant diabetes health promotion program', 'diabetes health program, and those in the control group (n\xa0=\xa071) group received a publicly available diabetes health brochure']","['diabetes knowledge, self-care activities, fatalism, and social support', 'diabetes knowledge and behaviors associated with diet and blood glucose testing', 'Cardiovascular disease risk']","[{'cui': 'C0562324', 'cui_str': 'Church (environment)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0037438'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",146.0,0.0355645,"Compared with the control group, the intervention group showed significant changes from pretest to posttest for diabetes knowledge and behaviors associated with diet and blood glucose testing.
","[{'ForeName': 'Laurie S', 'Initials': 'LS', 'LastName': 'Abbott', 'Affiliation': 'College of Nursing, Florida State University, Tallahassee, Florida.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Slate', 'Affiliation': 'Department of Statistics, Florida State University, Tallahassee, Florida.'}, {'ForeName': 'Lucinda J', 'Initials': 'LJ', 'LastName': 'Graven', 'Affiliation': 'College of Nursing, Florida State University, Tallahassee, Florida.'}]","Public health nursing (Boston, Mass.)",['10.1111/phn.12659']
901,31483377,Impact of early antiretroviral treatment on sexual behaviour in the INSIGHT Strategic Timing of Anti-Retroviral Treatment (START) Trial.,"BACKGROUND
Antiretroviral treatment (ART) reduces HIV infectiousness, but the effect of early ART on sexual behaviour is unclear.
METHODS
We assessed, within the START randomised trial that enrolled HIV-positive adults with CD4>500/mm, the effect of early (immediate) versus deferred ART on: (i) condomless sex with HIV-serodifferent partners (CLS-D); (ii) all condomless sex (CLS); (iii) HIV transmission-risk-sex (CLS-D-HIV-risk, defined as CLS-D and: not on ART or started ART < 6 months ago or viral load(VL)>200c/mL or no VL in past 6 months), during two year follow-up. Month-12 CLS-D (2010-2014) was the primary outcome.
RESULTS
Among 2562 MSM, there was no difference between immediate and deferred arms in CLS-D at month 12 [12.6% versus 13.1%; difference (95% CI): -0.4% (-3.1%, 2.2%), p = 0.75] or month 24, or in CLS. Among 2010 heterosexual men and women, CLS-D at month 12 tended to be higher in the immediate versus deferred arm [10.8% versus 8.3%; difference:2.5% (-0.1%, 5.2%), p = 0.062]; the difference was greater at month 24 [9.3% versus 5.6%; difference:3.7%(1.0%, 6.4%), p = 0.007], at which time CLS was higher in the immediate arm [20.7% versus 15.7%, p = 0.013]. CLS-D-HIV-risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2% versus 11.0%; difference: -10.7% (-12.5%, -8.9%), p < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8%, -5.3%), p < 0.001], due to viral suppression on ART.
CONCLUSIONS
A strategy of early ART had no effect on condomless sex with HIV-serodifferent partners among MSM, but resulted in modestly higher prevalence among heterosexuals. However, among MSM and heterosexuals, early ART resulted in a substantial reduction in HIV-transmission-risk-sex, to a very low absolute level.",2019,"CLS-D-HIV-risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2% versus 11.0%; difference: -10.7% (-12.5%, -8.9%), p < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8%, -5.3%), p < 0.001], due to viral suppression on ART.
","['2010 heterosexual men', 'enrolled HIV-positive adults with CD4>500/mm, the effect of early (immediate) versus']","['deferred ART on: (i) condomless sex with HIV-serodifferent partners (CLS-D); (ii) all condomless sex (CLS); (iii) HIV transmission-risk-sex (CLS-D-HIV-risk, defined as CLS-D and: not on ART or started ART\u200a<\u200a6 months ago or viral load(VL)>200c/mL or no VL']","['CLS-D-HIV-risk', 'sexual behaviour', 'time CLS']","[{'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",2562.0,0.322822,"CLS-D-HIV-risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2% versus 11.0%; difference: -10.7% (-12.5%, -8.9%), p < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8%, -5.3%), p < 0.001], due to viral suppression on ART.
","[{'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Lampe', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Rodger', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Burman', 'Affiliation': 'Denver Public Health, University of Colorado Health Sciences Center, Denver CO, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Grulich', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Friedland', 'Affiliation': 'Departments of Medicine and Epidemiology, Yale School of Medicine, New Haven CT United States.'}, {'ForeName': 'Wafaa El', 'Initials': 'WE', 'LastName': 'Sadr', 'Affiliation': 'Columbia University, New York, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Neaton', 'Affiliation': 'University of Minnesota, Minnesota, United States.'}, {'ForeName': 'Giulio M', 'Initials': 'GM', 'LastName': 'Corbelli', 'Affiliation': 'European AIDS Treatment Group, Bruxelles, Belgium.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Emery', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jean Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Université de Paris Diderot, Paris, France.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Gatell', 'Affiliation': 'University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gerstoft', 'Affiliation': 'Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kiat', 'Initials': 'K', 'LastName': 'Ruxrungtham', 'Affiliation': 'Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Monica Barbosa de', 'Initials': 'MB', 'LastName': 'Souza', 'Affiliation': 'Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Phillips', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002359']
902,31483451,Effects of Individual Placement and Support Supplemented With Cognitive Remediation and Work-Focused Social Skills Training for People With Severe Mental Illness: A Randomized Clinical Trial.,"Importance
Individual placement and support (IPS) seems to be an effective vocational intervention for people with severe mental illness, but its effects have not yet been shown in the Danish welfare model. Also, effects may be enhanced by adding cognitive remediation and work-focused social skills training (IPS with enhancements [IPSE]).
Objectives
To investigate the effects of IPS vs IPSE vs service as usual (SAU) on a population of individuals with severe mental illness in Denmark.
Design, Setting, and Participants
This was an investigator-initiated, 3-group, parallel, assessor-blinded randomized clinical trial that used early-intervention teams or community mental health services in 3 Danish cities to recruit participants with severe mental illness. Participants were randomly assigned to receive IPS, IPSE, or SAU from November 2012 to February 2016, and follow-up continued until August 2017.
Interventions
Participants allocated to the IPS intervention received vocational support per the principles of the IPS model. Participants in the IPSE arm received cognitive remediation and social skills training in addition to IPS. The group receiving SAU received vocational rehabilitation at the Danish job centers.
Main Outcomes and Measures
The primary outcome was the number of hours in competitive employment or education during the 18-month follow-up. Secondary outcomes included intergroup differences in employment or education at any point during follow-up; time to employment or education; and cognitive and social functioning, self-esteem, and self-efficacy.
Results
Of the 720 included participants (mean [SD] age, 32.8 [9.9] years; 276 [38.3%] women), 243 received IPS, 238 received IPSE, and 239 received SAU. Most participants (551 [76.5%]) were diagnosed with a schizophrenia spectrum disorder. During the 18-month follow-up, the IPSE group worked or studied a mean (SD) of 488.1 (735.6) hours, compared with 340.8 (573.8) hours in the group receiving SAU (success-rate difference [SRD], 0.151 [95% CI, 0.01-0.295]; P = .016). The mean (SD) in the IPS group was 411 (656.9) (SRD, 0.127 [95% CI, -0.017 to 0.276]; P = .004). There was no difference between IPS and IPSE in any vocational outcomes, and the 3 groups showed no differences in any nonvocational outcomes, except that the IPS and IPSE groups were more satisfied with the services received than the group receiving SAU (IPS vs SAU: SRD, 0.310 [95% CI, 0.167-0.445]); IPSE vs SAU: SRD, 0.341 [95% CI, 0.187-0.478]).
Conclusions and Relevance
Compared with SAU, IPS and IPSE seem to be viable routes to increase employment and education rates in people with severe mental illness in Denmark, but no additional effects were observed by enhancing IPS.
Trial Registration
ClinicalTrials.gov identifier: NCT01722344.",2019,"There was no difference between IPS and IPSE in any vocational outcomes, and the 3 groups showed no differences in any nonvocational outcomes, except that the IPS and IPSE groups were more satisfied with the services received than the group receiving SAU (IPS vs SAU:","['individuals with severe mental illness in Denmark', 'Most participants (551 [76.5%]) were diagnosed with a schizophrenia spectrum disorder', 'People With Severe Mental Illness', 'people with severe mental illness', '3 Danish cities to recruit participants with severe mental illness']","['SAU (IPS vs SAU', 'IPS intervention received vocational support per the principles of the IPS model', 'cognitive remediation and social skills training', 'Individual placement and support (IPS', 'SAU, IPS and IPSE', 'vocational rehabilitation', 'IPS, IPSE, or SAU', 'Individual Placement and Support Supplemented With Cognitive Remediation and Work-Focused Social Skills Training', 'IPS vs IPSE vs service as usual (SAU', 'IPSE', 'early-intervention teams or community mental health services']","['employment or education at any point during follow-up; time to employment or education; and cognitive and social functioning, self-esteem, and self-efficacy.\nResults', 'employment and education rates', 'IPS and IPSE', 'number of hours in competitive employment or education during the 18-month follow-up']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0150777', 'cui_str': 'Social skills training (procedure)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0034996', 'cui_str': 'Vocational rehabilitation (regime/therapy)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0242687', 'cui_str': 'Early Intervention'}, {'cui': 'C0009475', 'cui_str': 'Community Mental Health Services'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.188686,"There was no difference between IPS and IPSE in any vocational outcomes, and the 3 groups showed no differences in any nonvocational outcomes, except that the IPS and IPSE groups were more satisfied with the services received than the group receiving SAU (IPS vs SAU:","[{'ForeName': 'Thomas Nordahl', 'Initials': 'TN', 'LastName': 'Christensen', 'Affiliation': 'Mental Health Centre Copenhagen, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Iben Gammelgård', 'Initials': 'IG', 'LastName': 'Wallstrøm', 'Affiliation': 'Research Unit of Psychiatry, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Elsebeth', 'Initials': 'E', 'LastName': 'Stenager', 'Affiliation': 'Research Unit Psychiatry, Department of Regional Health Services, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Anders Bo', 'Initials': 'AB', 'LastName': 'Bojesen', 'Affiliation': 'Research Unit, Mental Health Centre Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Nordentoft', 'Affiliation': 'Mental Health Centre Copenhagen, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lene Falgaard', 'Initials': 'LF', 'LastName': 'Eplov', 'Affiliation': 'Research Unit, Mental Health Centre Copenhagen, Copenhagen, Denmark.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.2291']
903,31764959,Efficacy and Safety of Lanabecestat for Treatment of Early and Mild Alzheimer Disease: The AMARANTH and DAYBREAK-ALZ Randomized Clinical Trials.,"Importance
Alzheimer disease (AD) is a neurodegenerative disorder characterized by cognitive deterioration and impaired activities of daily living. Current treatments provide only minor symptomatic improvements with limited benefit duration. Lanabecestat, a brain-permeable inhibitor of human beta-site amyloid precursor protein-cleaving enzyme 1 (BACE1/β-secretase), was developed to modify the clinical course of AD by slowing disease progression.
Objective
To assess whether lanabecestat slows the progression of AD compared with placebo in patients with early AD (mild cognitive impairment) and mild AD dementia.
Design, Setting, and Participants
AMARANTH (first patient visit on September 30, 2014; last patient visit on October 4, 2018) and DAYBREAK-ALZ (first patient visit on July 1, 2016; last patient visit on September 28, 2018) were randomized, placebo-controlled, phase 2/3 and phase 3 clinical trials lasting 104 weeks and 78 weeks, respectively. AMARANTH and DAYBREAK-ALZ were multicenter, global, double-blind studies conducted at 257 and 251 centers, respectively, located in 15 and 18 countries or territories, respectively. A population-based sample of men and women aged 55 to 85 years who met National Institute on Aging-Alzheimer's Association criteria for early AD or mild AD dementia was screened using cognitive assessments, and the presence of amyloid was confirmed. Patients were excluded for unstable medical conditions or medication use, significant cerebrovascular pathologic findings, or a history of vitiligo and/or current evidence of postinflammatory hypopigmentation. AMARANTH screened 6871 patients; 2218 (32.3%) were randomized, and 539 patients completed the study. DAYBREAK-ALZ screened 5706 patients; 1722 (30.2%) were randomized, and 76 patients completed the study.
Interventions
Patients were randomized (1:1:1) to once-daily oral doses of lanabecestat (20 mg), lanabecestat (50 mg), or placebo.
Main Outcomes and Measures
The primary outcome measure was change from baseline on the 13-item Alzheimer Disease Assessment Scale-cognitive subscale. Secondary outcomes included Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory, Clinical Dementia Rating, Functional Activities Questionnaire, Mini-Mental State Examination, and Neuropsychiatric Inventory. Efficacy analyses were conducted on the intent-to-treat population.
Results
Among 2218 AMARANTH patients, the mean (SD) age was 71.3 (7.1) years, and 1177 of 2218 (53.1%) were women. Among 1722 DAYBREAK-ALZ patients, the mean (SD) age was 72.3 (7.0) years, and 1023 of 1722 (59.4%) were women. Both studies were terminated early after futility analysis. There were no consistent, reproducible dose-related findings on primary or secondary efficacy measures. Psychiatric adverse events, weight loss, and hair color changes were reported in a higher percentage of patients receiving lanabecestat than placebo.
Conclusions and Relevance
Treatment with lanabecestat was well tolerated and did not slow cognitive or functional decline.
Trial Registration
ClinicalTrials.gov identifiers: NCT02245737 and NCT02783573.",2020,"Psychiatric adverse events, weight loss, and hair color changes were reported in a higher percentage of patients receiving lanabecestat than placebo.
","['Among 1722 DAYBREAK-ALZ patients, the mean (SD) age was 72.3 (7.0) years, and 1023 of 1722 (59.4%) were women', 'AMARANTH screened 6871 patients; 2218 (32.3%) were randomized, and 539 patients completed the study', 'Among 2218 AMARANTH patients, the mean (SD) age was 71.3 (7.1) years, and 1177 of 2218 (53.1%) were women', '5706 patients; 1722 (30.2%) were randomized, and 76 patients completed the study', '257 and 251 centers, respectively, located in 15 and 18 countries or territories, respectively', 'Patients were excluded for unstable medical conditions or medication use, significant cerebrovascular pathologic findings, or a history of vitiligo and/or current evidence of postinflammatory hypopigmentation', 'patients with early AD (mild cognitive impairment) and mild AD dementia', 'Early and Mild Alzheimer Disease', ""A population-based sample of men and women aged 55 to 85 years who met National Institute on Aging-Alzheimer's Association criteria for early AD or mild AD dementia""]","['placebo', 'lanabecestat (20 mg), lanabecestat (50 mg), or placebo', 'Lanabecestat', 'lanabecestat']","['13-item Alzheimer Disease Assessment Scale-cognitive subscale', 'Efficacy and Safety', ""Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory, Clinical Dementia Rating, Functional Activities Questionnaire, Mini-Mental State Examination, and Neuropsychiatric Inventory"", 'Psychiatric adverse events, weight loss, and hair color changes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0002406', 'cui_str': 'Amaranth Dye'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0333612', 'cui_str': 'Postinflammatory hypopigmentation (morphologic abnormality)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1955974', 'cui_str': 'National Institute on Aging'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451074', 'cui_str': 'Dementia Rating Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0474378', 'cui_str': 'Hair color change (finding)'}]",539.0,0.552879,"Psychiatric adverse events, weight loss, and hair color changes were reported in a higher percentage of patients receiving lanabecestat than placebo.
","[{'ForeName': 'Alette M', 'Initials': 'AM', 'LastName': 'Wessels', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Pierre N', 'Initials': 'PN', 'LastName': 'Tariot', 'Affiliation': ""Banner Alzheimer's Institute, University of Arizona College of Medicine, Phoenix.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Zimmer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Selzler', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Sonja M', 'Initials': 'SM', 'LastName': 'Bragg', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Andersen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Landry', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Krull', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'AnnCatherine M', 'Initials': 'AM', 'LastName': 'Downing', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Willis', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Shcherbinin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Mullen', 'Affiliation': 'AstraZeneca, Waltham, Massachusetts, and Gaithersburg, Maryland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Barker', 'Affiliation': 'AstraZeneca, Waltham, Massachusetts, and Gaithersburg, Maryland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Schumi', 'Affiliation': 'AstraZeneca, Waltham, Massachusetts, and Gaithersburg, Maryland.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Shering', 'Affiliation': 'AstraZeneca, Waltham, Massachusetts, and Gaithersburg, Maryland.'}, {'ForeName': 'Brandy R', 'Initials': 'BR', 'LastName': 'Matthews', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Stern', 'Affiliation': ""Alzheimer's Disease Center, Boston University School of Medicine, Boston, Massachusetts.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Unités Mixtes de Recherche Institut National de la Santé et de la Recherche Médicale 1027, Université Toulouse III-Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Toronto Memory Program, Toronto, Ontario, Canada.'}, {'ForeName': 'Emer', 'Initials': 'E', 'LastName': 'MacSweeney', 'Affiliation': 'Re:Cognition Health, London, United Kingdom.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Boada', 'Affiliation': 'Research Center and Memory Clinic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociències Aplicades, Barcelona-Universitat Internacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Sims', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}]",JAMA neurology,['10.1001/jamaneurol.2019.3988']
904,31486890,A randomized double-blind controlled trial to assess the benefits of amisulpride and olanzapine combination treatment versus each monotherapy in acutely ill schizophrenia patients (COMBINE): methods and design.,"This report presents the rationale and design of a multi-center clinical trial that examines the efficacy and safety of antipsychotic combination treatment in acutely ill schizophrenia patients compared to antipsychotic monotherapy. Antipsychotic combination treatment is common in clinical practice worldwide, despite clinical guidelines generally not recommending such practice due to lacking evidence for its efficacy and safety. Olanzapine has a related chemical structure and comparable receptor-binding profile as clozapine, which demonstrated superior efficacy in combination studies, but has a more unfavorable side-effect profile compared to olanzapine. Amisulpride and olanzapine have shown promising therapeutic efficacy in meta-analyses in monotherapy for people with schizophrenia. Combining amisulpride and olanzapine, complementary receptor-binding properties may enhance efficacy and possibly reduce (or at least not augment) side effects due to the different receptor profiles and metabolization pathways. Accordingly, we hypothesize that patients treated with amisulpride plus olanzapine show greater improvement on the Positive and Negative Syndrome Scale total score after 8 weeks versus either monotherapy. A randomized, double-blind controlled trial is performed at 16 German centers comparing flexibly dosed monotherapy of oral amisulpride (400-800 mg/day), and olanzapine (10-20 mg/day) and amisulpride-olanzapine co-treatment. Sample size was calculated to be n = 101 per treatment arm, assuming an effect size of 0.500 and a two-sided alpha = 0.025 and beta = 0.90. Recruitment for this trial started in June 2012. Until December 2018, 328 patients have been randomized. Trial conduct has been extended to reach the projected sample size. Publication of the study results is expected in 2019 informing an evidence-based recommendation regarding specific antipsychotic combination treatment.",2020,"Olanzapine has a related chemical structure and comparable receptor-binding profile as clozapine, which demonstrated superior efficacy in combination studies, but has a more unfavorable side-effect profile compared to olanzapine.","['n', 'acutely ill schizophrenia patients', 'Until December 2018, 328 patients have been randomized', '16 German centers comparing', 'people with schizophrenia']","['amisulpride and olanzapine combination treatment', 'amisulpride plus olanzapine', 'Olanzapine', 'flexibly dosed monotherapy of oral amisulpride', 'olanzapine', 'amisulpride and olanzapine', 'antipsychotic combination treatment', 'Amisulpride and olanzapine', 'amisulpride-olanzapine co-treatment', 'antipsychotic monotherapy', 'Antipsychotic combination']",['Positive and Negative Syndrome Scale total score'],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",328.0,0.249677,"Olanzapine has a related chemical structure and comparable receptor-binding profile as clozapine, which demonstrated superior efficacy in combination studies, but has a more unfavorable side-effect profile compared to olanzapine.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmidt-Kraepelin', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, LVR-Clinic Düsseldorf, Heinrich-Heine-University Duesseldorf, Bergische Landstraße 2, 40629, Duesseldorf, Germany. Christian.Schmidt-Kraepelin@lvr.de.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Feyerabend', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, LVR-Clinic Düsseldorf, Heinrich-Heine-University Duesseldorf, Bergische Landstraße 2, 40629, Duesseldorf, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Engelke', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, LVR-Clinic Düsseldorf, Heinrich-Heine-University Duesseldorf, Bergische Landstraße 2, 40629, Duesseldorf, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Riesbeck', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, LVR-Clinic Düsseldorf, Heinrich-Heine-University Duesseldorf, Bergische Landstraße 2, 40629, Duesseldorf, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Meisenzahl-Lechner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, LVR-Clinic Düsseldorf, Heinrich-Heine-University Duesseldorf, Bergische Landstraße 2, 40629, Duesseldorf, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Gaebel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, LVR-Clinic Düsseldorf, Heinrich-Heine-University Duesseldorf, Bergische Landstraße 2, 40629, Duesseldorf, Germany.'}, {'ForeName': 'Pablo-Emilio', 'Initials': 'PE', 'LastName': 'Verde', 'Affiliation': 'Coordination Center for Clinical Trials, Medical Faculty, Heinrich-Heine-University, Duesseldorf, Germany.'}, {'ForeName': 'Henrike', 'Initials': 'H', 'LastName': 'Kolbe', 'Affiliation': 'Coordination Center for Clinical Trials, Medical Faculty, Heinrich-Heine-University, Duesseldorf, Germany.'}, {'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': 'Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Leucht', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Heres', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kluge', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Makiol', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Neff', 'Affiliation': 'LVR-Klinikum Langenfeld, Langenfeld, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lange', 'Affiliation': 'LVR-Klinikum Langenfeld, Langenfeld, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Englisch', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty Mannheim, Central Institute of Mental Health, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Zink', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty Mannheim, Central Institute of Mental Health, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Langguth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Timm', 'Initials': 'T', 'LastName': 'Poeppl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Reske', 'Affiliation': 'LVR-Klinikum Köln, Cologne, Germany.'}, {'ForeName': 'Euphrosyne', 'Initials': 'E', 'LastName': 'Gouzoulis-Mayfrank', 'Affiliation': 'LVR-Klinikum Köln, Cologne, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Gründer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty Mannheim, Central Institute of Mental Health, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Alkomiet', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Klinikum der Universität München, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Brockhaus-Dumke', 'Affiliation': 'Department of Psychiatry and Psychotherapy 1 und 2, Rheinhessen-Fachklinik Alzey, Academic Hospital of the University of Mainz, Alzey, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Jäger', 'Affiliation': 'Department of Psychiatry II, Bezirkskrankenhaus Günzburg, Ulm University, Günzburg, Germany.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Baumgärtner', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Bezirkskrankenhaus Augsburg, University Augsburg, Augsburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wobrock', 'Affiliation': 'Department of Psychiatry and Psychotherapy, County Hospitals Darmstadt-Dieburg, Groß-Umstadt, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Cordes', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, LVR-Clinic Düsseldorf, Heinrich-Heine-University Duesseldorf, Bergische Landstraße 2, 40629, Duesseldorf, Germany.'}]",European archives of psychiatry and clinical neuroscience,['10.1007/s00406-019-01063-4']
905,32434001,Platelet activation and placenta-mediated adverse pregnancy outcomes: an ancillary study to the Effects of Aspirin in Gestation and Reproduction trial.,"BACKGROUND
Platelet activation may play a role in the pathophysiology of placenta-mediated obstetrical complications, as evidenced by the efficacy of aspirin in preventing preeclampsia, but published data regarding the relationship between biomarkers for platelet activation and adverse obstetrical outcomes are sparse. In particular, it is unknown whether prepregnancy biomarkers of platelet activation are associated with adverse pregnancy outcomes.
OBJECTIVE
This study aimed to determine the following: (1) whether maternal plasma concentrations of platelet factor 4 are associated with risk of placenta-mediated adverse obstetrical outcomes, and (2) whether these associations are modified by low-dose aspirin.
STUDY DESIGN
This ancillary study included measurement of platelet factor 4 among 1185 of 1228 women of reproductive age enrolled in the Effects of Aspirin in Gestation and Reproduction trial with available plasma samples, with relevant outcomes assessed among 584 women with pregnancies lasting at least 20 weeks' gestation. We measured platelet factor 4 in plasma samples obtained at the prepregnancy study visit (before randomization to low-dose aspirin or placebo), 12 weeks' gestation, and 28 weeks' gestation. The primary outcome was a composite of hypertensive disorders of pregnancy, placental abruption, and small-for-gestational-age infant. We estimated the relative risks (RRs) and 95% confidence intervals (CIs) for the association between platelet factor 4 and the composite and individual outcomes at each time point using log-binomial regression that was weighted to account for potential selection bias and adjusted for age, body mass index, education, income, and smoking. To evaluate the potential effect modification of aspirin, we stratified the analyses by aspirin treatment assignment.
RESULTS
During follow-up, 95 women experienced the composite adverse obstetrical outcome, with 57 cases of hypertensive disorders of pregnancy, 35 of small for gestational age, and 6 of placental abruption. Overall, prepregnancy platelet factor 4 was positively associated with the composite outcome (third tertile vs first tertile; relative risk, 2.36; 95% confidence interval, 1.38-4.03) and with hypertensive disorders of pregnancy (third tertile vs first tertile; relative risk, 2.14; 95% confidence interval, 1.08-4.23). In analyses stratified by treatment group, associations were stronger in the placebo group (third tertile vs first tertile; relative risk, 3.36; 95% confidence interval, 1.42-7.93) than in the aspirin group (third tertile vs first tertile; relative risk, 1.78; 95% confidence interval, 0.90-3.50).
CONCLUSION
High concentrations of platelet factor 4 before pregnancy are associated with increased risk of placenta-mediated adverse pregnancy outcomes, particularly for hypertensive disorders of pregnancy. Aspirin may mitigate the increased risk of these outcomes among women with higher plasma concentrations of preconception platelet factor 4, but low-dose aspirin nonresponders may require higher doses of aspirin or alternate therapies to achieve obstetrical risk reduction.",2020,"In analyses stratified by treatment group, associations were stronger in the placebo (tertile 3 vs. tertile 1 RR 3.36, 95% CI 1.42, 7.93) versus the aspirin group (tertile 3 vs. tertile 1 RR 1.78, 95% CI 0.90, 3.50).
","[""1,185 of the 1,228 reproductive-age women enrolled in the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial with available plasma samples, with relevant outcomes assessed among 584 women with pregnancies lasting at least 20 weeks' gestation"", '95 women experienced the composite adverse obstetric outcome, with 57 cases of hypertensive disorders of pregnancy, 35 of small-for-gestational age (SGA), and 6 of placental abruption']","['Aspirin', 'aspirin', 'aspirin or placebo']","['composite of hypertensive disorders of pregnancy, placental abruption, and small-for-gestational age neonate', 'hypertensive disorders of pregnancy', 'Platelet activation and placenta-mediated adverse pregnancy outcomes']","[{'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0000832', 'cui_str': 'Placental abruption'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0000832', 'cui_str': 'Placental abruption'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}]",584.0,0.178718,"In analyses stratified by treatment group, associations were stronger in the placebo (tertile 3 vs. tertile 1 RR 3.36, 95% CI 1.42, 7.93) versus the aspirin group (tertile 3 vs. tertile 1 RR 1.78, 95% CI 0.90, 3.50).
","[{'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Theilen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, UT; Women and Newborns Clinical Program, Intermountain Healthcare, Salt Lake City, UT. Electronic address: lauren.theilen@hsc.utah.edu.'}, {'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Campbell', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, UT; Women and Newborns Clinical Program, Intermountain Healthcare, Salt Lake City, UT.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'Purdue-Smithe', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Jeannie G', 'Initials': 'JG', 'LastName': 'Radoc', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, UT; Women and Newborns Clinical Program, Intermountain Healthcare, Salt Lake City, UT.'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.026']
906,32494981,Comparison of S-1-cisplatin every 5 weeks with capecitabine-cisplatin every 3 weeks for HER2-negative gastric cancer (recurrent after S-1 adjuvant therapy or chemotherapy-naïve advanced): pooled analysis of HERBIS-2 (OGSG 1103) and HERBIS-4A (OGSG 1105) trials.,"BACKGROUND
We previously reported the HERBIS-4A phase II trial comparing S-1 plus cisplatin (SP) with capecitabine plus cisplatin (XP) in chemotherapy-naïve patients with HER2-negative advanced gastric cancer (GC). We performed a pooled analysis of HERBIS-4A and HERBIS-2, the phase II trial comparing SP with XP in HER2-negative recurrent GC patients with a recurrence-free interval after S-1 adjuvant therapy of ≥ 6 months.
PATIENTS AND METHODS
Patients were randomly assigned to receive either SP [S-1 (40-60 mg twice daily for 21 days) plus cisplatin (60 mg/m 2 on day 8), every 5 weeks] or XP [capecitabine (1000 mg/m 2 twice daily for 14 days) plus cisplatin (80 mg/m 2 on day 1), every 3 weeks].
RESULTS
In the pooled analysis, SP (n = 44-50) showed a longer progression-free survival [6.4 versus 5.1 months; hazard ratio (HR), 0.666; P = 0.062], overall survival (14.8 versus 10.6 months; HR, 0.695; P = 0.099), and time to treatment failure (4.6 versus 3.6 months; HR, 0.668; P = 0.045) as well as a higher disease control rate (86.4% versus 68.1%, P = 0.149) compared with XP (n = 47-51). A significant survival advantage for SP over XP was apparent in patients with a performance status of 0, a differentiated-type tumor histology, or a primary tumor localization to the upper portion of the stomach.
CONCLUSION
Our pooled analysis supports the use of SP in the first-line setting for patients with HER2-negative advanced or recurrent GC with a recurrence-free interval of ≥ 6 months.
CLINICAL TRIAL REGISTRATION
The HERBIS-2 trial was registered with UMIN-CTR as UMIN000006105.",2020,"A significant survival advantage for SP over XP was apparent in patients with a performance status of 0, a differentiated-type tumor histology, or a primary tumor localization to the upper portion of the stomach.
","['HER2-negative recurrent GC patients with a recurrence-free interval after S-1 adjuvant therapy of\u2009≥\u20096\xa0months', 'Patients', 'chemotherapy-naïve patients with HER2-negative advanced gastric cancer (GC', 'HER2-negative gastric cancer (recurrent after S-1 adjuvant therapy or chemotherapy-naïve advanced', 'patients with HER2-negative advanced or recurrent GC with a recurrence-free interval of\u2009≥\u20096\xa0months']","['S-1 plus cisplatin (SP) with\xa0capecitabine plus cisplatin (XP', 'XP', 'S-1-cisplatin', 'capecitabine-cisplatin', 'SP [S-1', 'cisplatin', 'XP [capecitabine']","['time to treatment failure', 'longer progression-free survival', 'overall survival', 'disease control rate']","[{'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0278502', 'cui_str': 'Gastric cancer recurrent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.153097,"A significant survival advantage for SP over XP was apparent in patients with a performance status of 0, a differentiated-type tumor histology, or a primary tumor localization to the upper portion of the stomach.
","[{'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Kawakami', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Kindai University, 377-2 Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan. kawakami_h@med.kindai.ac.jp.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Surgery, Osaka Prefectural General Medical Center, Osaka-shi, Japan.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Gastroenterological Surgery, Higashiosaka City Medical Center, Higashiosaka, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Akamaru', 'Affiliation': 'Department of Surgery, Ikeda Municipal Hospital, Ikeda, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Surgery, Yao Municipal Hospital, Yao, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Endo', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Kindai University, Osaka-sayama, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': 'Department of Surgery, Sakai City Medical Center, Sakai, Japan.'}, {'ForeName': 'Youichi', 'Initials': 'Y', 'LastName': 'Makari', 'Affiliation': 'Department of Medical Oncology, Kindai University Nara Hospital, Ikoma, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'Cancer Center, Izumi City General Hospital, Izumi, Japan.'}, {'ForeName': 'Toshimasa', 'Initials': 'T', 'LastName': 'Tsujinaka', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Kurokawa', 'Affiliation': 'Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Taroh', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of clinical oncology,['10.1007/s10147-020-01711-z']
907,32097267,Effects of Specific Exercise Therapy on Adolescent Patients with Idiopathic Scoliosis: A Prospective Controlled Cohort Study.,"STUDY DESIGN
A prospective controlled cohort study.
OBJECTIVE
To explore the interventional effect of exercise therapy on idiopathic scoliosis (IS) and identify an optimal intervention window.
SUMMARY OF BACKGROUND DATA
Early conservative treatment is helpful for IS. In addition to bracing, current evidence suggests that exercise can play an important role.
METHODS
We included 99 patients with IS who were treated at the Guangdong Xinmiao Scoliosis Center from August 2013 to September 2017. The inclusion criteria were: 1) new IS diagnosis, 2) Cobb angle 10-25°, 3) Risser 0-3 grade, 4) only treated with the Xinmiao treatment system (XTS; >3 days/week, >1 h/day), and 5) follow-up longer than 1 year. Patients were divided into three age groups: A: <10 years (n = 29); B: 10-12 years (n = 24); and C: 13-15 years (n = 46). The percentages of curve improvement (Cobb angle decrease ≥5°), stability (Cobb angle change × ±5°), and progression (Cobb angle increase ≥5°) were compared.
RESULTS
The groups showed significant differences for major curve correction, Risser sign, first referral, and final follow-up of the main curve (all p < 0.05). The major curve in group A decreased significantly by 6.8° (44% correction), compared to 3.1° (18% correction) and 1.5° (9% correction) in groups B and C, respectively. In group A, 69.0% (20/29) had curve improvement, 27.6% (8/29) stabilized and 3.4% (1/29) progressed. In group B, 45.8% (11/24) improved, 50% (12/24) stabilized, and 4.2% (1/24) progressed. In group C, 26.1% (12/46) improved, 63.0% (29/46) stabilized, and 10.9% (5/46) progressed. There was also a significant difference in final Risser grade among the groups (p < 0.05).
CONCLUSION
For IS patients with Cobb angles between 10° and 25°, our exercise protocol can effectively control or improve curve progression. Younger patients with a lower Risser grade are most likely to respond.
LEVEL OF EVIDENCE
2.",2020,"The groups showed significant differences for major curve correction, Risser sign, first referral, and final follow-up of the main curve (all p < 0.05).","['Adolescent Patients with Idiopathic Scoliosis', '99 patients with IS who were treated at the Guangdong Xinmiao Scoliosis Center from August 2013 to September 2017', 'Younger patients with a lower Risser grade']","['exercise therapy', 'Specific Exercise Therapy']","['final Risser grade', 'major curve correction, Risser sign, first referral, and final follow-up of the main curve', 'percentages of curve improvement (Cobb angle decrease ≥5°), stability (Cobb angle change × ±5°), and progression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0595995', 'cui_str': 'Idiopathic scoliosis (disorder)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle (observable entity)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",99.0,0.0375908,"The groups showed significant differences for major curve correction, Risser sign, first referral, and final follow-up of the main curve (all p < 0.05).","[{'ForeName': 'Delong', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Spine Surgery, the 1st Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Sizhe', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Primary and Secondary School Health Care Center of Zhongshan City, Guangdong, China.'}, {'ForeName': 'Xuexiang', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of sports and Arts, Guangzhou Sport University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jingfan', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Spine Center, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Xuan', 'Affiliation': 'Xinmiao Scoliosis Prevention Center of Guangdong Province, Guangzhou, Guangdong, China.'}, {'ForeName': 'Junlin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Spine Center, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zifang', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Spine Surgery, the 1st Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}]",Spine,['10.1097/BRS.0000000000003451']
908,32437568,Association of motivations and barriers with participation and performance in a pedometer-based intervention.,"BACKGROUND
A randomized trial of a pedometer-based intervention with weekly activity goals led to increased walking among dialysis patients. However, the association of participant-expressed motivations and barriers to participation and performance in such an intervention has not been determined.
METHODS
Thirty dialysis patients were randomized to a 12-week pedometer-based intervention with weekly step goals. Participants were asked about motivations and barriers to the increasing activity via weekly semi-scripted telephone interviews. We examined the association of these motivations and barriers with achieving weekly goals, reaching overall targets and increasing steps through multivariable linear and logistic regression analyses adjusted for age, sex, body mass index, dialysis modality and baseline steps.
RESULTS
The most common motivations were desire to maintain/improve functional ability (30%) and activity (30%). The most common barriers were health-related (33%). Motivation to maintain/improve functional ability was associated with achieving weekly goals 17.9% more often [95% confidence interval (CI) 1.7-34.2] and with a greater increase in steps (1524 steps; 95% CI 61-2989) than those lacking this motivation. Experiencing a health-related barrier was not associated with the decreased achievement of weekly goals but was associated with lower odds of reaching overall targets (odds ratio = 0.06; 95% CI 0.01-0.53) and a smaller increase in steps (-1640 steps, 95% CI -3244 to -36). No patients who reported weather/environmental barriers or safety concerns reached overall targets.
CONCLUSIONS
Participants who express a desire to maintain/improve functional ability may be particularly suited for activity interventions. Health-related setbacks should be met with revised goals. Reporting environmental or safety concerns may merit lowering overall targets.",2020,Motivation to maintain/improve functional ability was associated with achieving weekly goals 17.9% more often [95% confidence interval (CI) 1.7-34.2] and with a greater increase in steps (1524 steps; 95% CI 61-2989) than those lacking this motivation.,"['dialysis patients', 'Thirty dialysis patients']",[],"['Motivation to maintain/improve functional ability', 'functional ability']","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}]",[],"[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.0511484,Motivation to maintain/improve functional ability was associated with achieving weekly goals 17.9% more often [95% confidence interval (CI) 1.7-34.2] and with a greater increase in steps (1524 steps; 95% CI 61-2989) than those lacking this motivation.,"[{'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Sheshadri', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Piyawan', 'Initials': 'P', 'LastName': 'Kittiskulnam', 'Affiliation': 'Department of Medicine-Division of Nephrology, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Delgado', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sudore', 'Affiliation': 'Department of Medicine, Division of Nephrology, San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Lai', 'Affiliation': 'Department of Medicine, Division of Gastroenterology/Hepatology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Johansen', 'Affiliation': 'Division of Nephrology, Hennepin County Medical Center, Minneapolis, MN, USA.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa047']
909,32013589,Impact of visual and auditory deprivation on speech perception and production in adults.,"Speech perception relies on auditory and visual cues and there are strong links between speech perception and production. We aimed to evaluate the role of auditory and visual modalities on speech perception and production in adults with impaired hearing or sight versus those with normal hearing and sight. We examined speech perception and production of three isolated vowels (/i/, /y/, /u/), which were selected based on their different auditory and visual perceptual saliencies, in 12 deaf adults who used one or two cochlear implants (CIs), 14 congenitally blind adults, and 16 adults with normal sight and hearing. The results showed that the deaf adults who used a CI had worse vowel identification and discrimination perception and they also produced vowels that were less typical or precise than other participants. They had different tongue positions in speech production, which possibly partly explains the poorer quality of their spoken vowels. Blind individuals had larger lip openings and smaller lip protrusions for the rounded vowel and unrounded vowels, compared to the other participants, but they still produced vowels that were similar to those produced by the adults with normal sight and hearing. In summary, the deaf adults, even though they used CIs, had greater difficulty in producing accurate vowel targets than the blind adults, whereas the blind adults were still able to produce accurate vowel targets, even though they used different articulatory strategies.",2020,"Blind individuals had larger lip openings and smaller lip protrusions for the rounded vowel and unrounded vowels, compared to the other participants, but they still produced vowels that were similar to those produced by the adults with normal sight and hearing.","['adults', 'adults with impaired hearing or sight versus those with normal hearing and sight', '12 deaf adults who used one or two cochlear implants (CIs), 14 congenitally blind adults, and 16 adults with normal sight and hearing']","['visual and auditory deprivation', 'auditory and visual modalities']","['auditory and visual cues', 'vowel identification and discrimination perception', 'larger lip openings and smaller lip protrusions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1384666', 'cui_str': 'Hypoacusis'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0009199', 'cui_str': 'Auditory Prosthesis'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0333056', 'cui_str': 'Protrusion (morphologic abnormality)'}]",16.0,0.020714,"Blind individuals had larger lip openings and smaller lip protrusions for the rounded vowel and unrounded vowels, compared to the other participants, but they still produced vowels that were similar to those produced by the adults with normal sight and hearing.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Turgeon', 'Affiliation': 'Department of Linguistic, UQAM , Montréal, Canada.'}, {'ForeName': 'Paméla', 'Initials': 'P', 'LastName': 'Trudeau-Fisette', 'Affiliation': 'Department of Linguistic, UQAM , Montréal, Canada.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Lepore', 'Affiliation': 'Department of Psychology, Université de Montréal , Montréal, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lippé', 'Affiliation': 'Department of Psychology, Université de Montréal , Montréal, Canada.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Ménard', 'Affiliation': 'Department of Linguistic, UQAM , Montréal, Canada.'}]",Clinical linguistics & phonetics,['10.1080/02699206.2020.1719207']
910,31453119,"Tualang honey ameliorates viral load, CD4 counts and improves quality of life in asymptomatic human immunodeficiency virus infected patients.","This is the first study to report on the effects of honey in asymptomatic HIV positive subjects in ameliorating CD4 count, viral load (VL) and quality of life (QOL). It is a randomized, controlled, open labelled study, comparing the effects of Tualang honey (TH) administration for six months at three different doses: 20 g (THL), 40 g (THI) or 60 g (THH) daily compared with control (no administered treatment, THC). Only asymptomatic HIV positive subjects (n=95) having CD4 count 250-600 cell/ml, not on antiretrovirals were enrolled. Blood, (together with QOL questionnaires administration) were investigated at baseline, three and six months (CD4 cell count) while VL was determined only at baseline and six months. Significant reductions in CD4 counts in THL and THC groups (p= 0.003 for both) were seen with no significant reductions in the CD4 counts in THI and THH groups (p=0.447 and 0.053 respectively). There was improvement in VL in THC and THI (130% and 32% respectively) and reductions in THL and THH (26% and 8% respectively). Within and between group analyses for VL indicated significant differences between THL and THH compared to THC. In addition, significant improvement in QOL of groups which received TH was noted. TH has the potential to improve the QOL (physical and psychological) and CD4 counts. There was a trend of lower VL in asymptomatic HIV subjects following TH administration thus supporting the possible role of TH in boosting the immune system by improving CD4 counts, causing VL reductions in HIV positive subjects.",2019,Significant reductions in CD4 counts in THL and THC groups (p= 0.003 for both) were seen with no significant reductions in the CD4 counts in THI and THH groups (p=0.447 and 0.053 respectively).,"['asymptomatic HIV positive subjects', 'Only asymptomatic HIV positive subjects (n=95) having CD4 count 250-600 cell/ml, not on antiretrovirals were enrolled', 'HIV positive subjects', 'asymptomatic human immunodeficiency virus infected patients']","['20 g (THL), 40 g (THI) or 60 g (THH) daily compared with control (no administered treatment, THC', 'Tualang honey (TH']","['QOL (physical and psychological) and CD4 counts', 'THL and THH', 'VL in THC and THI', 'CD4 counts', 'quality of life', 'QOL', 'ameliorating CD4 count, viral load (VL) and quality of life (QOL']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0019906', 'cui_str': 'Honey'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0034380'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",600.0,0.0405834,Significant reductions in CD4 counts in THL and THC groups (p= 0.003 for both) were seen with no significant reductions in the CD4 counts in THI and THH groups (p=0.447 and 0.053 respectively).,"[{'ForeName': 'Wan Nazirah', 'Initials': 'WN', 'LastName': 'Wan Yusuf', 'Affiliation': 'Pharmacology Department, School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan, Malaysia.'}, {'ForeName': 'Wan Mohd Zahiruddin', 'Initials': 'WMZ', 'LastName': 'Wan Mohammad', 'Affiliation': 'Biostatistics Unit, School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan, Malaysia.'}, {'ForeName': 'Siew Hua', 'Initials': 'SH', 'LastName': 'Gan', 'Affiliation': 'School of Pharmacy, Building 2, Level 5, Room 40 (2-5-40), Monash University Malaysia, Jalan Lagoon Selatan, 47500, Bandar Sunway, Selangor Darul Ehsan, Malaysia.'}, {'ForeName': 'Mahiran', 'Initials': 'M', 'LastName': 'Mustafa', 'Affiliation': 'Infectious Disease Unit, Department of Medicine, Raja Perempuan Zainab II Hospital, 15586, Kota Bharu, Kelantan, Malaysia.'}, {'ForeName': 'Che Badariah', 'Initials': 'CB', 'LastName': 'Abd Aziz', 'Affiliation': 'Physiology Department, School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan, Malaysia.'}, {'ForeName': 'Siti Amrah', 'Initials': 'SA', 'LastName': 'Sulaiman', 'Affiliation': 'Pharmacology Department, School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan, Malaysia.'}]",Journal of traditional and complementary medicine,['10.1016/j.jtcme.2018.05.003']
911,32441386,Different freezing time of superficial liquid nitrogen cryotherapy in treatment of recalcitrant alopecia areata: Randomized clinical trial.,"Recalcitrant alopecia areata is not uncommon in clinical practice and some patients experienced either treatment failure or recurrence with most of the conventional therapies. Several studies have evaluated the efficacy of cryotherapy in the treatment of alopecia areata with controversial results. This study aimed to optimize the ideal timing of liquid nitrogen cryospraying to achieve the most favorable results. A total of 75 patients with recalcitrant alopecia areata were treated with superficial cryotherapy, two freeze-thaw cycles, each consisted of 3 to 5, 8 to 10, and 13 to 15 seconds in group A, B, and C, respectively. Good to moderate improvement was achieved in 65.2%, 76%, and 76.2% in groups A, B, and C, respectively, with no statistically significant difference. However, the mean percentage of improvement was significantly higher in group B and C compared to group A (P-value < .05 for each). Superficial liquid nitrogen cryotherapy is an effective therapeutic modality for recalcitrant alopecia areata. Moreover, using 8 to 10 seconds dual freeze-thaw cycles is the optimum timing.",2020,"However, the mean percentage of improvement was significantly higher in group B and C compared to group A (p value <0.05 for each).","['75 patients with recalcitrant alopecia areata', 'recalcitrant alopecia areata']","['Superficial liquid nitrogen cryotherapy', 'superficial liquid nitrogen cryotherapy', 'cryotherapy', 'superficial cryotherapy']","['Recalcitrant alopecia areata', 'mean percentage of improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0260055', 'cui_str': 'Liquid nitrogen'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",75.0,0.0145758,"However, the mean percentage of improvement was significantly higher in group B and C compared to group A (p value <0.05 for each).","[{'ForeName': 'Amira A', 'Initials': 'AA', 'LastName': 'Abdel Motaleb', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Assiut University, Asyut, Egypt.'}, {'ForeName': 'Doaa S', 'Initials': 'DS', 'LastName': 'Sayed', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Assiut University, Asyut, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13640']
912,31450969,A randomized trial of telemedicine for migraine management.,"OBJECTIVE
To determine whether synchronous video-based telemedicine visits with specialists are feasible and to evaluate clinical effectiveness, patient perceptions, and other benefits of telemedicine visits for follow-up migraine care in a tertiary headache center.
DESIGN
A one-year, randomized clinical trial.
RESULTS
Fifty patients were screened and 45 entered the study (43 women, two men). Out of 96 scheduled visits, 89 were successfully conducted using telemedicine. Eighteen patients (out of 22) in the telemedicine cohort and 12 patients (out of 23) in the in-office cohort completed the study. In this small study, clinical outcomes, namely improvement in MIDAS, number of headache days, and average severity at 12 months for participants in the telemedicine group, were not different from those in the in-office group. Convenience was rated higher and visit times were shorter in the telemedicine group.
CONCLUSIONS
In this cohort of patients with severe migraine-related disability, telemedicine was a feasible mode of treatment and an effective alternative to in-office visits for follow-up migraine care. Physician productivity could be higher with telemedicine, and patients may get better access because of its convenience.
TRIAL REGISTRATION
This study is listed on ClinicalTrials.gov (NCT01706003).",2019,"Convenience was rated higher and visit times were shorter in the telemedicine group.
","['Fifty patients were screened and 45 entered the study (43 women, two men', 'Eighteen patients (out of 22) in the telemedicine cohort and 12 patients (out of 23) in the in-office cohort completed the study']","['synchronous video-based telemedicine visits', 'telemedicine']","['MIDAS, number of headache days, and average severity', 'Physician productivity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",89.0,0.0901954,"Convenience was rated higher and visit times were shorter in the telemedicine group.
","[{'ForeName': 'Deborah I', 'Initials': 'DI', 'LastName': 'Friedman', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Balaraman', 'Initials': 'B', 'LastName': 'Rajan', 'Affiliation': 'College of Business and Economics, California State University East Bay, Hayward, CA, USA.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Seidmann', 'Affiliation': 'Simon Business School, University of Rochester, Rochester, NY, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419868250']
913,31444080,Extended depth-of-focus toric intraocular lens targeted for binocular emmetropia or slight myopia in the nondominant eye: Visual and refractive clinical outcomes.,"PURPOSE
To compare the visual and refractive outcomes with a diffractive toric extended depth-of-focus (EDOF) intraocular lens (IOL) when both eyes are targeted for emmetropia and the nondominant eye is targeted for slight myopia.
SETTING
Three clinical practices, United States.
DESIGN
Prospective case series.
METHODS
Patients having routine cataract surgery with bilateral Tecnis Symfony toric EDOF IOL implantation were assigned to 1 of 2 groups. In 1 group, the nondominant eye was targeted for -0.50 diopter (D) (mini-monovision). Assessments included uncorrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (4 m), intermediate (66 cm), and near (40 cm) and the postoperative residual refractive error.
RESULTS
Forty patients were enrolled in each group, with 1 dropout. The mean postoperative residual refractive astigmatism was 0.25 D in both groups, with no statistically significant difference. The mean residual refractive astigmatism was 0.50 D or lower in 92% of eyes (72/78) in the mini-monovision group and 95% of eyes (74/78) in the emmetropia group 3 months postoperatively. The mini-monovision group had slightly worse uncorrected visual acuity at 4 m than the emmetropia group (0.16 versus 0.09; P = .002) but better uncorrected acuity at 40 cm (0.25 versus 0.34; P < .001). Binocular uncorrected acuity was not statistically significantly different between groups at 4 m (-0.03 versus -0.01; P = .33) or 66 cm (0.06 versus 0.04; P = .34) but was statistically significant at 40 cm (0.25 versus 0.19; P = .03).
CONCLUSIONS
The EDOF toric IOL provided functional distance, intermediate, and near vision. A slight monovision approach appears to improve near visual acuity.",2019,The mini-monovision group had slightly worse uncorrected visual acuity at 4 m than the emmetropia group (0.16 versus 0.09; P = .002) but better uncorrected acuity at 40 cm (0.25 versus 0.34; P < .001).,"['Forty patients were enrolled in each group, with 1 dropout', 'Patients having routine cataract surgery with bilateral Tecnis Symfony toric EDOF IOL implantation', 'Three clinical practices, United States']",['diffractive toric extended depth-of-focus (EDOF) intraocular lens (IOL'],"['uncorrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (4\xa0m), intermediate (66\xa0cm), and near (40\xa0cm) and the postoperative residual refractive error', 'near visual acuity', 'Binocular uncorrected acuity', 'mean postoperative residual refractive astigmatism', 'mean residual refractive astigmatism', 'uncorrected visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0034951', 'cui_str': 'Refractive Disorders'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}]",40.0,0.200625,The mini-monovision group had slightly worse uncorrected visual acuity at 4 m than the emmetropia group (0.16 versus 0.09; P = .002) but better uncorrected acuity at 40 cm (0.25 versus 0.34; P < .001).,"[{'ForeName': 'Helga P', 'Initials': 'HP', 'LastName': 'Sandoval', 'Affiliation': 'Carolina Eyecare Physicians, LLC, Mt. Pleasant, South Carolina, USA. Electronic address: helga.sandoval@carolinaeyecare.com.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lane', 'Affiliation': 'Associated Eye Care, Stillwater, Minnesota, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Slade', 'Affiliation': 'Slade & Baker Vision, Houston, Texas, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Potvin', 'Affiliation': 'Science in Vision, Akron, New York, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Donnenfeld', 'Affiliation': 'Ophthalmic Consultants of Long Island, Garden City, New York, USA.'}, {'ForeName': 'Kerry D', 'Initials': 'KD', 'LastName': 'Solomon', 'Affiliation': 'Carolina Eyecare Physicians, LLC, Mt. Pleasant, South Carolina, USA.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2019.05.019']
914,31444082,An objective scatter index cutoff point as a powerful objective criterion for preoperative nuclear cataract decision-making based on ROC analysis.,"PURPOSE
To assess the correlation between clinical cataract surgery indication and the objective scatter index (OSI) by defining the optimal OSI cutoff point in the surgery scheduling.
SETTING
Ophthalmology service, Consorcio Hospital General Universitario, Valencia, Spain.
DESIGN
Prospective triple-masked randomized single-center study.
METHODS
Patients with cataractous eyes were recruited, and those with anterior segment disease, abnormal posterior pole, and/or previous ocular surgery were excluded. The principle of double-pass aberrometry was used by the main investigator to determine an OSI, after measuring subjective refraction and corrected distance visual acuity (CDVA), and then slitlamp evaluation was carried out by an independent researcher. The surgical decision was based on the current protocol according to the European guidelines. Correlation between the surgical decision, CDVA, and OSI were analyzed and an OSI discriminative value was calculated, implementing a receiver operating characteristic (ROC) curve.
RESULTS
The study comprised 106 eyes (73 patients). The analysis established an inverse linear correlation between OSI and CDVA (r = -0.455, P < .0001). The comparison of the mean OSI between the surgical group (7.05 ± 4.65 [SD]) and the nonsurgical group (2.92 ± 1.88), revealed statistically significant differences (P = 5.04 × 10 -9 ). The OSI score 3.2 was determined as the optimal cutoff value to discriminate surgical treatment (sensitivity 80%, specificity 84%).
CONCLUSIONS
An optimal OSI value, according to an ROC curve calculation, was capable of providing clinicians with a powerful criterion for preoperative decision-making, thus suggesting an end to the subjectivity implicit in the cataract surgery decision-making process.",2019,"The OSI score 3.2 was determined as the optimal cutoff value to discriminate surgical treatment (sensitivity 80%, specificity 84%).
","['Patients with cataractous eyes were recruited, and those with anterior segment disease, abnormal posterior pole, and/or previous ocular surgery were excluded', 'Ophthalmology service, Consorcio Hospital General Universitario, Valencia, Spain', '106 eyes (73 patients']",[],"['surgical decision, CDVA, and OSI', 'mean OSI', 'objective scatter index (OSI', 'OSI score', 'OSI discriminative value']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0348014', 'cui_str': 'Anterior segment (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0444576', 'cui_str': 'Posterior pole (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0587689', 'cui_str': 'Ophthalmology service (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],"[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439742', 'cui_str': 'Scattered (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",73.0,0.0506894,"The OSI score 3.2 was determined as the optimal cutoff value to discriminate surgical treatment (sensitivity 80%, specificity 84%).
","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Monferrer-Adsuara', 'Affiliation': 'Department of Ophthalmology, Consorcio Hospital General Universitario de Valencia, Valencia, Spain. Electronic address: clara_cma@hotmail.com.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Mata-Moret', 'Affiliation': 'Department of Ophthalmology, Consorcio Hospital General Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Castro-Navarro', 'Affiliation': 'Department of Ophthalmology, Consorcio Hospital General Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Hernández-Garfella', 'Affiliation': 'Department of Ophthalmology, Consorcio Hospital General Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Gracia-García', 'Affiliation': 'Department of Ophthalmology, Consorcio Hospital General Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ortiz-Salvador', 'Affiliation': 'Department of Ophthalmology, Consorcio Hospital General Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Remolí-Sargues', 'Affiliation': 'Department of Ophthalmology, Consorcio Hospital General Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Cervera-Taulet', 'Affiliation': 'Department of Ophthalmology, Consorcio Hospital General Universitario de Valencia, Valencia, Spain.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2019.05.029']
915,31463925,"Isometric handgrip training reduces blood pressure and wave reflections in East Asian, non-medicated, middle-aged and older adults: a randomized control trial.","PURPOSE
The aim of this study was to investigate the effects of isometric handgrip (IHG) training on central and peripheral blood pressure (BP) and wave reflections in East Asian non-medicated middle-aged and older adults.
METHODS
Twenty-two men and women (mean age 65 ± 11 years) who were not actively involved in regular resistance or endurance training were randomly assigned to a group that did IHG and a control (CON) group. The IHG training was comprised of four unilateral 2-min isometric contractions at 30% of maximal voluntary contraction using a programmed handgrip dynamometer with 1-min rest periods for 5 days per week for 8 weeks.
RESULTS
Baseline central systolic BP (cSBP), brachial systolic BP (bSBP), brachial diastolic BP (bDBP), and the augmentation index (AIx) (via an automated applanation tonometric system) did not differ significantly between the groups. Compared to baseline, cSBP, bSBP, bDBP, and AIx decreased significantly after the 8-week study period in the IHG group (P < 0.05). No significant changes in central and peripheral BP and AIx were observed in the CON group.
CONCLUSIONS
These results suggest that IHG training could reduce central and peripheral BP and wave reflections in East Asian non-medicated middle-aged and older adults.",2020,"No significant changes in central and peripheral BP and AIx were observed in the CON group.
","['East Asian, non-medicated, middle-aged and older adults', 'Twenty-two men and women (mean age 65\u2009±\u200911\xa0years) who were not actively involved in regular resistance or endurance training', 'East Asian non-medicated middle-aged and older adults']","['did IHG and a control (CON', 'IHG training', 'CON', 'isometric handgrip (IHG) training', 'Isometric handgrip training']","['cSBP, bSBP, bDBP, and AIx', 'central and peripheral BP and AIx', 'central and peripheral BP and wave reflections', 'central and peripheral blood pressure (BP) and wave reflections', 'blood pressure and wave reflections', 'Baseline central systolic BP (cSBP), brachial systolic BP (bSBP), brachial diastolic BP (bDBP), and the augmentation index (AIx) (via an automated applanation tonometric system']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0999177', 'cui_str': 'Genus Aix (organism)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",22.0,0.0303594,"No significant changes in central and peripheral BP and AIx were observed in the CON group.
","[{'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Okamoto', 'Affiliation': 'Department of Exercise Physiology, Nippon Sport Science University, 7-1-1, Fukasawa, Setagaya-ku, Tokyo, 158-8508, Japan. tokamoto@nittai.ac.jp.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Exercise Physiology, Nippon Sport Science University, 7-1-1, Fukasawa, Setagaya-ku, Tokyo, 158-8508, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Kobayashi', 'Affiliation': 'Center for Fundamental Education, Teikyo University of Science, Tokyo, Japan.'}]",Aging clinical and experimental research,['10.1007/s40520-019-01330-3']
916,31433108,Randomized Trial of 3 Techniques of Perineal Skin Closure During Second-Degree Perineal Laceration Repair.,"INTRODUCTION
Perineal lacerations during childbirth are common, and suturing the perineal skin during repair has been associated with increased postpartum pain. This study sought to test the hypothesis that no difference in postpartum perineal pain exists between 3 methods of skin closure for second-degree repair: suture, no suture, and surgical glue.
METHODS
A single-blind randomized controlled trial of women after vaginal birth who had a second-degree perineal laceration was conducted at a tertiary care teaching hospital from August 2014 to April 2017. Women were randomized to perineal skin closure with suture, no suture, or surgical glue using a 1:1:1 allocation. Pain was assessed using the short-form McGill Pain Questionnaire, a 100-mm visual analog scale (VAS), and Present Pain Index (PPI) at one day, 2 weeks, 6 weeks, and 3 months postpartum. Wound healing was assessed at 6 weeks using the Redness, Edema, Ecchymosis, Drainage, Approximation (REEDA) scale. Pain scores were compared across groups using a chi-square test, Mann-Whitney U test, or analysis of variance where appropriate.
RESULTS
A total of 35 women were randomized: 14 received suture, 11 had no suture, and 10 received surgical glue for perineal skin repair. Demographic characteristics were similar between groups. At 2 weeks postpartum, women with suture had higher median pain scores on the short-form McGill Pain Questionnaire (15.0 suture vs 2.0 glue vs 2.0 no suture, P = .03) and VAS (50.0 suture vs 3.0 glue vs 7.0 no suture, P = .02). Significant differences in pain were not seen on the PPI. At 3 months, women in the suture group had higher median pain scores on the short-form McGill Pain Questionnaire compared with surgical glue (1.0 vs 0, P = .04). Wound healing was similar across groups (REEDA score: 0 suture vs 1.0 no suture, vs 0 surgical glue, P = .24).
DISCUSSION
Compared with no suture and surgical glue, suturing the perineal skin was associated with the highest postpartum pain scores.",2019,"At 3 months, women in the suture group had higher median pain scores on the short-form McGill Pain Questionnaire compared with surgical glue (1.0 vs 0, P = .04).","['women after vaginal birth who had a second-degree perineal laceration was conducted at a tertiary care teaching hospital from August 2014 to April 2017', '35 women were randomized: 14 received']","['perineal skin closure with suture, no suture, or surgical glue using a 1:1:1 allocation', 'suture, 11 had no suture, and 10 received surgical glue for perineal skin repair', 'Perineal Skin Closure', 'skin closure for second-degree repair: suture, no suture, and surgical glue']","['McGill Pain Questionnaire', 'Demographic characteristics', 'short-form McGill Pain Questionnaire, a 100-mm visual analog scale (VAS), and Present Pain Index (PPI', 'pain', 'Redness, Edema, Ecchymosis, Drainage, Approximation (REEDA) scale', 'highest postpartum pain scores', 'median pain scores', 'Wound healing', 'Pain scores', 'VAS', 'Pain']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0269870', 'cui_str': 'Second degree perineal laceration (disorder)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]","[{'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0017780', 'cui_str': 'Glues'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0443298', 'cui_str': 'Second degree (qualifier value)'}]","[{'cui': 'C0024985', 'cui_str': 'McGill Pain Questionnaire'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire (assessment scale)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0222045'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0848200', 'cui_str': 'Afterbirth pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",35.0,0.144383,"At 3 months, women in the suture group had higher median pain scores on the short-form McGill Pain Questionnaire compared with surgical glue (1.0 vs 0, P = .04).","[{'ForeName': 'Carolyn W', 'Initials': 'CW', 'LastName': 'Swenson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Lisa Kane', 'Initials': 'LK', 'LastName': 'Low', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Kowalk', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Dee E', 'Initials': 'DE', 'LastName': 'Fenner', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.'}]",Journal of midwifery & women's health,['10.1111/jmwh.13020']
917,32495016,Postoperative comparison of laparoscopic radical resection and open abdominal radical hysterectomy for cervical cancer patient.,"PURPOSE
There are limited data regarding postoperative complications and autoimmune reactions caused by surgery in early-stage cervical cancer patients who underwent laparoscopic radical resection (LRR). This study aimed to investigate the therapeutic effect of LRR of cervical cancer patients and its effect on cytokines.
METHODS
168 patients with cervical cancer were enrolled. The patients were divided into open group and laparoscopic group according to the random number table method, with 84 cases in each group. The surgical-related indexes and the incidence of complications of the two groups were observed, and the IFN-γ, TNF, and IL-1/2/4/6/8/10/12 levels in peripheral blood were compared before and after surgery in both groups.
RESULTS
The operation time of the patients in the laparoscopic group was significantly shorter than that in the open group (119.56 ± 45.26 vs. 206.36 ± 54.39, P < 0.01). The intraoperative blood loss in the laparoscopic group was significantly less than that in the open group (155.29 ± 57.58 vs. 529.58 ± 162.4, P < 0.01). The postoperative visual analog scale (VAS) score was also significantly lower than that in the open group (3.65 ± 0.88 vs. 6.32 ± 1.12, P < 0.01). There was no significant difference in the incidence of complications between the two groups. The degree of inflammatory cytokines changes caused by LRR was less than that of open radical surgery (P < 0.001).
CONCLUSIONS
LRR surgery has less stress on patients with early cervical cancer than open surgery within 5 days after surgery, which has certain reference value for early cervical cancer treatment.",2020,"The degree of inflammatory cytokines changes caused by LRR was less than that of open radical surgery (P < 0.001).
","['168 patients with cervical cancer were enrolled', 'early-stage cervical cancer patients who underwent', 'cervical cancer patient', 'cervical cancer patients', 'patients with early cervical cancer']","['laparoscopic radical resection and open abdominal radical hysterectomy', 'laparoscopic', 'laparoscopic radical resection (LRR', 'LRR surgery']","['IFN-γ, TNF, and IL-1/2/4/6/8/10/12 levels in peripheral blood', 'degree of inflammatory cytokines changes', 'postoperative visual analog scale (VAS) score', 'intraoperative blood loss', 'incidence of complications', 'operation time']","[{'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",168.0,0.0199014,"The degree of inflammatory cytokines changes caused by LRR was less than that of open radical surgery (P < 0.001).
","[{'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Dong', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Dehong', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China. yinianwuji212@163.com.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China. hcfy98@126.com.""}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05606-2']
918,10768307,"Effectiveness, tolerability, and safety of topiramate in children with partial-onset seizures. Topiramate YP Study Group.","PURPOSE
Children with partial-onset seizures, with or without secondary generalization, participating in a double-blind, placebo-controlled trial of topiramate (TPM) as adjunctive therapy were eligible to participate in an open-label, long-term extension study.
METHODS
A total of 83 children (mean age, 9 years) continued long-term open-label TPM therapy in which the dosages of TPM and concomitant antiepileptic drugs (AEDs) were adjusted according to clinical response (mean TPM dosage, 9 mg/kg/day).
RESULTS
Seizure frequency over the last 3 months of therapy was reduced > or =50% in 57% of children; 14% of children were seizure-free > or =6 months at the last visit. During treatment periods up to 2 1/2 years (mean, 15 months), 6% of children discontinued because of treatment-emergent adverse events; 13% discontinued because of inadequate seizure control.
CONCLUSIONS
From these findings, TPM is well tolerated and provides long-term seizure control in children with partial-onset seizures.",2000,"RESULTS
Seizure frequency over the last 3 months of therapy was reduced > or =50% in 57% of children; 14% of children were seizure-free > or =6 months at the last visit.","['Children with partial-onset seizures, with or without secondary generalization, participating in a double-blind', 'children with partial-onset seizures', '83 children (mean age, 9 years) continued long-term open-label TPM therapy in which the dosages of TPM and concomitant antiepileptic drugs (AEDs) were adjusted according to clinical response (mean TPM dosage, 9 mg/kg/day']","['placebo', 'Topiramate', 'TPM', 'topiramate', 'topiramate (TPM']","['Effectiveness, tolerability, and safety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0017324', 'cui_str': 'Generalization'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0651569', 'cui_str': ""9-(1'-hydroxy-2'-(hydroxymethyl)ethoxy)methylguanine""}, {'cui': 'C0439418', 'cui_str': 'kg/day'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",83.0,0.0432732,"RESULTS
Seizure frequency over the last 3 months of therapy was reduced > or =50% in 57% of children; 14% of children were seizure-free > or =6 months at the last visit.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ritter', 'Affiliation': 'Minnesota Epilepsy Group, P.A., St. Paul 55102, USA.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Glauser', 'Affiliation': ''}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Elterman', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wyllie', 'Affiliation': ''}]",Epilepsia,[]
919,31092823,"Concentration and avidity of antibodies to different circumsporozoite epitopes correlate with RTS,S/AS01E malaria vaccine efficacy.","RTS,S/AS01E has been tested in a phase 3 malaria vaccine study with partial efficacy in African children and infants. In a cohort of 1028 subjects from one low (Bagomoyo) and two high (Nanoro, Kintampo) malaria transmission sites, we analysed IgG plasma/serum concentration and avidity to CSP (NANP-repeat and C-terminal domains) after a 3-dose vaccination against time to clinical malaria events during 12-months. Here we report that RTS,S/AS01E induces substantial increases in IgG levels from pre- to post-vaccination (p < 0.001), higher in NANP than C-terminus (2855 vs 1297 proportional change between means), and higher concentrations and avidities in children than infants (p < 0.001). Baseline CSP IgG levels are elevated in malaria cases than controls (p < 0.001). Both, IgG magnitude to NANP (hazard ratio [95% confidence interval] 0.61 [0.48-0.76]) and avidity to C-terminus (0.07 [0.05-0.90]) post-vaccination are significantly associated with vaccine efficacy. IgG avidity to the C-terminus emerges as a significant contributor to RTS,S/AS01E-mediated protection.",2019,Baseline CSP IgG levels are elevated in malaria cases than controls (p < 0.001).,"['1028 subjects from one low (Bagomoyo) and two high (Nanoro, Kintampo) malaria transmission sites, we analysed IgG plasma/serum concentration and avidity to CSP (NANP-repeat and C-terminal domains) after a 3-dose vaccination against time to clinical malaria events during 12-months', 'African children and infants']",['NANP'],"['Baseline CSP IgG levels', 'IgG levels', 'Concentration and avidity of antibodies']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0521124', 'cui_str': 'Against (qualifier value)'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",1028.0,0.124564,Baseline CSP IgG levels are elevated in malaria cases than controls (p < 0.001).,"[{'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Dobaño', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain. carlota.dobano@isglobal.org.'}, {'ForeName': 'Hèctor', 'Initials': 'H', 'LastName': 'Sanz', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Sorgho', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé, BP 218, Nanoro, Burkina Faso.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dosoo', 'Affiliation': 'Kintampo Health Research Centre, P.O. Box 200, Kintampo, Brong-Ahafo, Ghana.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Mpina', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, P.O. Box 74, Bagamoyo, Tanzania.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Ubillos', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Aguilar', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Ford', 'Affiliation': 'IAVI - Human Immunology Laboratory, Imperial College, 369 Fulham Road, London, SW10 9NH, UK.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Díez-Padrisa', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Nana Aba', 'Initials': 'NA', 'LastName': 'Williams', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Aintzane', 'Initials': 'A', 'LastName': 'Ayestaran', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Ousmane', 'Initials': 'O', 'LastName': 'Traore', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé, BP 218, Nanoro, Burkina Faso.'}, {'ForeName': 'Augusto J', 'Initials': 'AJ', 'LastName': 'Nhabomba', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Rua 12, Cambeve, Vila de Manhiça, CP 1929, Maputo, Mozambique.'}, {'ForeName': 'Chenjerai', 'Initials': 'C', 'LastName': 'Jairoce', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Rua 12, Cambeve, Vila de Manhiça, CP 1929, Maputo, Mozambique.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Waitumbi', 'Affiliation': 'US Army Medical Research Directorate-Kenya, Walter Reed Army Institute of Research/Kenya Medical Research Institute, Box 54, Kisumu, 40100, Kenya.'}, {'ForeName': 'Selidji Todagbe', 'Initials': 'ST', 'LastName': 'Agnandji', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné (CERMEL), BP 242, Lambaréné, Gabon.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kariuki', 'Affiliation': 'Kenya Medical Research Institute/Centre for Global Health, P.O. Box 54840 00200, Kisumu, Siaya, Nairobi, Kenya.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Abdulla', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, P.O. Box 74, Bagamoyo, Tanzania.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Aponte', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mordmüller', 'Affiliation': 'Institute of Tropical Medicine and German Center for Infection Research, University of Tübingen, Wilhelmstraße 27, 72074, Tübingen, Germany.'}, {'ForeName': 'Kwaku Poku', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Centre, P.O. Box 200, Kintampo, Brong-Ahafo, Ghana.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Owusu-Agyei', 'Affiliation': 'Kintampo Health Research Centre, P.O. Box 200, Kintampo, Brong-Ahafo, Ghana.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé, BP 218, Nanoro, Burkina Faso.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Campo', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Moncunill', 'Affiliation': 'ISGlobal, Hospital Clínic - Universitat de Barcelona, Rosselló 153, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Gyan', 'Affiliation': 'Kintampo Health Research Centre, P.O. Box 200, Kintampo, Brong-Ahafo, Ghana.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'Valim', 'Affiliation': 'Department of Osteopathic Medical Specialties, Michigan State University, 909 Fee Road, Room B 309 West Fee Hall, East Lansing, MI, 48824, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Daubenberger', 'Affiliation': 'Swiss Tropical and Public Health Institute, Socinstrasse 57, 4002, Basel, Switzerland.'}]",Nature communications,['10.1038/s41467-019-10195-z']
920,31465307,"Inspiratory Muscle Training After Heart Valve Replacement Surgery Improves Inspiratory Muscle Strength, Lung Function, and Functional Capacity: A RANDOMIZED CONTROLLED TRIAL.","PURPOSE
The aim of this study was to analyze the effects of inspiratory muscle training (IMT) as a therapeutic strategy after heart valve replacement surgery (HVRS).
METHODS
A double-blind, randomized, clinical trial that included patients undergoing elective HVRS, without post-operative complications, were allocated to 2 groups: IMT group (IMT-G) and IMT placebo group (IMT-PG). The IMT started 3 d after surgery and was performed twice daily for 4 wk. Lung function, maximum inspiratory pressure (MIP) as a measure of inspiratory muscle strength, functional capacity, and quality of life were assessed pre-operatively and at the end of training.
RESULTS
The IMT-G recovered pre-operative MIP and lung function values after 4 wk of training. This group also increased the distance walked during the 6-min walk test (6MWD). In the IMT-PG, the values of MIP were below those found pre-operatively, with impairment of lung function and lower 6MWD in the final evaluation. At the end of IMT, MIP was correlated with the 6MWD and with the spirometry variables.
CONCLUSIONS
IMT performed for 4 wk after HVRS was effective in restoring the values of inspiratory muscle strength and lung function to the pre-operative level and increasing the functional capacity assessed by the 6MWD. Furthermore, an association between lung function and functional capacity was observed, demonstrating the clinical relevance of the use of IMT in the rehabilitation process of these patients.",2019,"In the IMT-PG, the values of MIP were below those found pre-operatively, with impairment of lung function and lower 6MWD in the final evaluation.","['heart valve replacement surgery (HVRS', 'patients undergoing elective HVRS, without post-operative complications']","['Inspiratory Muscle Training', 'inspiratory muscle training (IMT', 'IMT', 'IMT group (IMT-G) and IMT placebo']","['lung function and lower 6MWD', 'lung function and functional capacity', 'inspiratory muscle strength, functional capacity, and quality of life', 'Inspiratory Muscle Strength, Lung Function, and Functional Capacity', 'Lung function, maximum inspiratory pressure (MIP', 'distance walked during the 6-min walk test (6MWD', 'values of MIP', 'inspiratory muscle strength and lung function', 'IMT-G recovered pre-operative MIP and lung function values']","[{'cui': 'C0190173', 'cui_str': 'Heart valve replacement (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0034380'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",,0.0252196,"In the IMT-PG, the values of MIP were below those found pre-operatively, with impairment of lung function and lower 6MWD in the final evaluation.","[{'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Cargnin', 'Affiliation': 'Programa de Pós-graduação em Ciências da Saúde, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil (Ms Cargnin and Dr Dal Lago); Programa de Pós-graduação em Ciências da Reabilitação (UFCSPA), Porto Alegre, Brazil (Drs Karsten and Dal Lago); Departamento de Fisioterapia, Universidade do Estado de Santa Catarina (UDESC), Florianópolis, Brazil (Dr Karsten); Programa de Pós-graduação em Fisioterapia (UDESC), Florianópolis, Brazil (Dr Karsten); Faculdade de Medicina, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil (Dr Guaragna); and Departamento de Fisioterapia (UFCSPA), Porto Alegre, Brazil (Dr Dal Lago).'}, {'ForeName': 'Marlus', 'Initials': 'M', 'LastName': 'Karsten', 'Affiliation': ''}, {'ForeName': 'João Carlos Vieira da Costa', 'Initials': 'JCVDC', 'LastName': 'Guaragna', 'Affiliation': ''}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Dal Lago', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000409']
921,31465308,"""Let's Boogie"": FEASIBILITY OF A DANCE INTERVENTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE.","PURPOSE
Exercise is an effective treatment for individuals with chronic obstructive pulmonary disease (COPD); however, lack of adherence to exercise programs is a common barrier. Innovative approaches to exercise are needed to increase patient engagement and adherence. Dance has been shown to benefit populations with neurological conditions. The aim of our study was to investigate the feasibility of a dance intervention in individuals with COPD.
METHODS
Twenty individuals with COPD participated in a 1-hr dance class delivered twice a week for 8 wk. The primary outcome measure of the study was the feasibility determined by enrollment rate, attendance rate, adverse events, and participant satisfaction. Secondary outcomes included functional capacity, balance, anxiety and depression, steps count, and health-related quality of life.
RESULTS
Of the 47 individuals approached, 37 (79%) were interested in the program and 23 (49%) consented to participate and 20 completed the program with no adverse events and a mean attendance rate of 78%. The mean age ± SD of the participants was 73.4 ± 7.6 yr and 70% were females. Participant satisfaction with the program was high and significant improvements were achieved in the 6-min walk test (P = .03), Balance Evaluation Systems Test (BESTest) (P < .01), Chronic Respiratory Disease Questionnaire (P = .001), and the Activities-specific Balance Confidence scale (P = .007).
CONCLUSION
Dance is an enjoyable, safe, and feasible way to exercise for those with COPD. This pilot study will inform the design of a larger randomized controlled trial to determine effectiveness of dance on exercise capacity, balance, and quality of life for people with COPD.",2019,"Participant satisfaction with the program was high and significant improvements were achieved in the 6-min walk test (P = .03), Balance Evaluation Systems Test (BESTest) (P < .01), Chronic Respiratory Disease Questionnaire (P = .001), and the Activities-specific Balance Confidence scale (P = .007).
","['people with COPD', 'Twenty individuals with COPD participated in a 1-hr dance class delivered twice a week for 8 wk', 'individuals with chronic obstructive pulmonary disease (COPD', 'individuals with COPD', 'The mean age ± SD of the participants was 73.4 ± 7.6 yr and 70% were females']",['dance intervention'],"['feasibility determined by enrollment rate, attendance rate, adverse events, and participant satisfaction', 'functional capacity, balance, anxiety and depression, steps count, and health-related quality of life', 'Activities-specific Balance Confidence scale', '6-min walk test', 'Balance Evaluation Systems Test (BESTest', 'mean attendance rate', 'Chronic Respiratory Disease Questionnaire', 'exercise capacity, balance, and quality of life']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}]","[{'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C2733457', 'cui_str': 'ABC (activities-specific balance confidence) scale'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3164900', 'cui_str': 'Chronic respiratory disease questionnaire (assessment scale)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",20.0,0.0792223,"Participant satisfaction with the program was high and significant improvements were achieved in the 6-min walk test (P = .03), Balance Evaluation Systems Test (BESTest) (P < .01), Chronic Respiratory Disease Questionnaire (P = .001), and the Activities-specific Balance Confidence scale (P = .007).
","[{'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Wshah', 'Affiliation': 'Respiratory Medicine, West Park Healthcare Centre, Toronto, Ontario, Canada (Drs Goldstein, and Brooks, Mr Wshah, and Ms Butler); Rehabilitation Sciences Institute (Drs Patterson, Goldstein, and Brooks and Mr Wshah) and Departments of Physical Therapy (Ms Butler and Drs Patterson, Goldstein, and Brooks) and Medicine (Dr Goldstein), University of Toronto, Toronto, Ontario, Canada; School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada (Dr Brooks).'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Butler', 'Affiliation': ''}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Patterson', 'Affiliation': ''}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Goldstein', 'Affiliation': ''}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Brooks', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000428']
922,31440874,Exploration of Intervention Strategies to Reduce Public Stigma Associated with Gambling Disorder.,"Stigma associated with gambling disorder is complex, and is a key obstacle that prevents sufferers from seeking early help for their condition. However, little research has addressed how best to reduce gambling stigma. This study explored the effectiveness of video intervention styles, that have been used to reduce public stigma for conditions such as mental illness and substance use disorders. This was done to determine which would be most suitable, considering the unique characteristics of gambling disorder. An online survey of 164 people living in Australia was conducted which examined attitudes toward gamblers experiencing problems before and after an intervention. Participants were randomly allocated to one of three interventions (contact, education, advocacy) or a control video. The study found that each intervention was associated with changes to different components of stigma. Importantly, the education intervention increased labelling, but reduced stereotype endorsement and anger. Advocacy also reduced anger, attributions of character flaws, and anticipated discrimination and recoverability. While these interventions were generally effective at reducing stigma, the contact intervention was mixed, effectively intervening for some aspects of stigma, but increasing stigma on others. No single intervention reduced all aspects of stigma, suggesting that a complementary approach utilising specific elements of each intervention style could be used to deliver relevant information and effectively reduce stigma. Taken together, this suggests that research should be conducted into comprehensive, combined interventions, that include aspects of all three intervention styles, in an attempt to reduce more aspects of stigma simultaneously.",2020,"While these interventions were generally effective at reducing stigma, the contact intervention was mixed, effectively intervening for some aspects of stigma, but increasing stigma on others.",['164 people living in Australia was conducted which examined attitudes toward gamblers experiencing problems before and after an intervention'],"['video intervention styles', 'three interventions (contact, education, advocacy) or a control video']","['anger, attributions of character flaws, and anticipated discrimination and recoverability', 'stereotype endorsement and anger']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}]",164.0,0.0317752,"While these interventions were generally effective at reducing stigma, the contact intervention was mixed, effectively intervening for some aspects of stigma, but increasing stigma on others.","[{'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Brown', 'Affiliation': 'School of Health, Medical and Applied Sciences, CQUniversity, Rockhampton, QLD, 4701, Australia.'}, {'ForeName': 'Alex M T', 'Initials': 'AMT', 'LastName': 'Russell', 'Affiliation': 'Experimental Gambling Research Laboratory, School of Health, Medical and Applied Sciences, CQUniversity, Level 6, 400 Kent St, Sydney, NSW, 2000, Australia. a.m.russell@cqu.edu.au.'}]",Journal of gambling studies,['10.1007/s10899-019-09888-3']
923,10768306,Nonfocal generalized tonic-clonic seizures: response during long-term topiramate treatment. Topiramate YTC/YTCE Study Group.,"PURPOSE
A total of 131 adults and children (mean age, 27 years; range, 3-59 years) with generalized tonic-clonic seizures (GTCS) of nonfocal origin resistant to other antiepileptic drugs (AEDs) were treated with open-label topiramate (TPM) after completing double-blind placebo-controlled trials.
RESULTS
The mean duration of open-label TPM treatment was 387 days (range, 14-909 days); the mean TPM dose was 7 mg/kg/day (range, 1-16 mg/kg/day). At the last study visit, the frequency of GTCS was reduced > or =50% from baseline in 63% of patients and by > or =75% in 44%. Among patients treated > or =6 months, 16% were GTCS free > or =6 months despite a pretreatment seizure frequency of one GTCS/week (median). Treatment with TPM was being continued in 82% of patients (n = 107) at the last visit. During treatment periods of up to 2.5 years, 11 (8%) patients discontinued TPM because of adverse events and seven (5%) because of inadequate seizure control.
CONCLUSIONS
TPM therapy was well tolerated, and seizure control was maintained with long-term, open-label therapy in patients with GTCS, leading to prolonged seizure-free intervals in some patients with seizures previously resistant to AED therapy.",2000,"At the last study visit, the frequency of GTCS was reduced > or =50% from baseline in 63% of patients and by > or =75% in 44%.","['131 adults and children (mean age, 27 years; range, 3-59 years) with generalized tonic-clonic seizures (GTCS) of nonfocal origin resistant to other antiepileptic drugs (AEDs) were treated with']","['placebo', 'TPM therapy', 'open-label topiramate (TPM', 'TPM', 'Topiramate YTC/YTCE']","['tolerated, and seizure control', 'frequency of GTCS', 'mean duration of open-label TPM treatment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0494475', 'cui_str': 'Generalized Tonic-Clonic Seizures'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C3653913', 'cui_str': 'Other antiepileptics in ATC'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",131.0,0.0319559,"At the last study visit, the frequency of GTCS was reduced > or =50% from baseline in 63% of patients and by > or =75% in 44%.","[{'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Montouris', 'Affiliation': 'The Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, Missouri 63017, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Biton', 'Affiliation': ''}, {'ForeName': 'W E', 'Initials': 'WE', 'LastName': 'Rosenfeld', 'Affiliation': ''}]",Epilepsia,[]
924,31919973,Effect of an intervention on the congruence of nurses' and patients' perceptions of patient-centred care: A pre-test post-test study.,"AIMS AND OBJECTIVES
To evaluate measurement invariance of the Individualized Care Scale (ICS) across patients and nurses, and assess the degree of congruence in nurses' and patients' perceptions on patient-centredness and the impact of an intervention there on.
METHODS
A pre-post intervention study design with an expert by experience intervention was conducted in 2016 to 2017. Nurses (n = 138) and patients (n = 199) of two hospital departments in Belgium were surveyed. Patient-centredness was measured using the ICS (ICS-Nurse and ICS-Patient). Measurement invariance was evaluated by conducting multiple-group confirmatory factor analysis. Unpaired t tests and difference in difference analysis were used to evaluate the degree of congruence in nurses' and patients' perceptions on patient-centredness and assess pre-post changes in nurses' and patients' scores, respectively. SQUIRE guidelines were followed to report the study.
RESULTS
There was no evidence of measurement non-invariance. Nurses perceived the individuality of care more positively than patients both before and after the implementation of the intervention. Pre-post changes in nurses' and patients' scores were not statistically significant.
CONCLUSION
There is a significant gap between the perceptions of nurses and patients regarding the support and provision of individual care: nurses consider provided care as more individualized than patients do. To orient nurses' perspectives more towards their patients' perspective, multicomponent interventions are needed. Researchers and hospital managers may use the ICS to evaluate interventions that have the ability to close the gap in nurses' and patients' perceptions of patient-centredness. Embedding experts by experience in the professionals' team has the potential to foster patient-centredness but needs to focus on patients and nurses equally.",2020,"Pre-post changes in nurses' and patients' scores were not statistically significant.
","['2016 to 2017', 'Nurses (n = 138) and patients (n = 199) of two hospital departments in Belgium were surveyed', ""nurses' and patients' perceptions of patient-centred care""]",['Individualized Care Scale (ICS'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019961', 'cui_str': 'Hospital Departments'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[{'cui': 'C0222045'}],[],,0.0247697,"Pre-post changes in nurses' and patients' scores were not statistically significant.
","[{'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Castro', 'Affiliation': 'Faculty of Social Sciences, KU Leuven-University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Van Regenmortel', 'Affiliation': 'Faculty of Social Sciences, KU Leuven-University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Vanhaecht', 'Affiliation': 'Department of Public Health & Primary Care, Institute for Healthcare Policy, KU Leuven-University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Sermeus', 'Affiliation': 'Department of Public Health & Primary Care, Institute for Healthcare Policy, KU Leuven-University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Carlotte', 'Initials': 'C', 'LastName': 'Kiekens', 'Affiliation': 'Department of Development and Regeneration, KU Leuven-University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Claes', 'Affiliation': 'Faculty of Medicine, Laboratory of Nephrology, Department of Microbiology & Immunology, KU Leuven-University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Luk', 'Initials': 'L', 'LastName': 'Bruyneel', 'Affiliation': 'Department of Public Health & Primary Care, Institute for Healthcare Policy, KU Leuven-University of Leuven, Leuven, Belgium.'}]",Journal of evaluation in clinical practice,['10.1111/jep.13348']
925,31451521,"Effect of Intermittent Versus Continuous Low-Dose Aspirin on Nasal Epithelium Gene Expression in Current Smokers: A Randomized, Double-Blinded Trial.","A chemopreventive effect of aspirin (ASA) on lung cancer risk is supported by epidemiologic and preclinical studies. We conducted a randomized, double-blinded study in current heavy smokers to compare modulating effects of intermittent versus continuous low-dose ASA on nasal epithelium gene expression and arachidonic acid (ARA) metabolism. Fifty-four participants were randomized to intermittent (ASA 81 mg daily for one week/placebo for one week) or continuous (ASA 81 mg daily) for 12 weeks. Low-dose ASA suppressed urinary prostaglandin E2 metabolite (PGEM; change of -4.55 ± 11.52 from baseline 15.44 ± 13.79 ng/mg creatinine for arms combined, P = 0.02), a surrogate of COX-mediated ARA metabolism, but had minimal effects on nasal gene expression of nasal or bronchial gene-expression signatures associated with smoking, lung cancer, and chronic obstructive pulmonary disease. Suppression of urinary PGEM correlated with favorable changes in a smoking-associated gene signature ( P < 0.01). Gene set enrichment analysis (GSEA) showed that ASA intervention led to 1,079 enriched gene sets from the Canonical Pathways within the Molecular Signatures Database. In conclusion, low-dose ASA had minimal effects on known carcinogenesis gene signatures in nasal epithelium of current smokers but results in wide-ranging genomic changes in the nasal epithelium, demonstrating utility of nasal brushings as a surrogate to measure gene-expression responses to chemoprevention. PGEM may serve as a marker for smoking-associated gene-expression changes and systemic inflammation. Future studies should focus on NSAIDs or agent combinations with broader inhibition of pro-inflammatory ARA metabolism to shift gene signatures in an anti-carcinogenic direction.",2019,Gene set enrichment analysis (GESA) showed that ASA intervention led to 1079 enriched gene sets from the Canonical Pathways within the Molecular Signatures Database.,"['Fifty-four participants were randomized to intermittent ', 'current heavy smokers', 'current smokers']","['intermittent versus continuous low dose ASA', 'aspirin (ASA', 'placebo', 'intermittent versus continuous low dose aspirin', 'ASA intervention', 'ASA']","['nasal epithelium gene expression', 'lung cancer risk', 'Suppression of urinary PGEM', 'urinary prostaglandin E2 metabolite (PGEM', 'nasal epithelium gene expression and arachidonic acid (ARA) metabolism']","[{'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0857118', 'cui_str': 'Heavy smoker'}, {'cui': 'C3241966'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0599331', 'cui_str': 'Nasal Epithelium'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",54.0,0.22044,Gene set enrichment analysis (GESA) showed that ASA intervention led to 1079 enriched gene sets from the Canonical Pathways within the Molecular Signatures Database.,"[{'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Garland', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona. lgarland@azcc.arizona.edu.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Guillen-Rodriguez', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Chiu-Hsieh', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yozwiak', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Hao Helen', 'Initials': 'HH', 'LastName': 'Zhang', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Alberts', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Davis', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Szabo', 'Affiliation': 'Division of Cancer Prevention, NCI/NIH, Boston, Massachusetts.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Merenstein', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Lel', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Hanqiao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Avrum E', 'Initials': 'AE', 'LastName': 'Spira', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Beane', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Wojtowicz', 'Affiliation': 'Division of Cancer Prevention, NCI/NIH, Boston, Massachusetts.'}, {'ForeName': 'H-H Sherry', 'Initials': 'HS', 'LastName': 'Chow', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0036']
926,32439603,The effects of imaginary eating on visual food cue reactivity: An event-related potential study.,"Previous research has demonstrated that imagining consumption of a specific type of food helps individuals to consume less of that food. The present event-related potential study aimed at investigating the underlying neural correlates of this appetite-reducing strategy. A total of 86 women (mean age = 23.65 years) were randomly assigned to one of three imagination conditions. In each condition, they listened to a guided imagery script that either described the eating of 30 colorful button-shaped chocolates (M&Ms), the sorting of 30 M&Ms by color, or the sorting of 30 marbles by color. Subsequently to the imagery task, the participants were presented with images of M&Ms and marbles while their electroencephalogram and craving ratings were recorded. The results showed that imaginary eating did not reduce the appetitive value of M&M pictures. The M&M sorting group reported enhanced craving and showed increased late positivity toward M&M pictures (300-600 ms after picture onset) compared to the two other groups. The present findings indicate that the imagined handling of food increases food cue reactivity and that imaginary eating is not a reliable method to reduce appetite.",2020,The results showed that imaginary eating did not reduce the appetitive value of M&M pictures.,['86 women (mean age\u202f=\u202f23.65 years'],['imaginary eating'],"['enhanced craving', 'appetitive value of M&M pictures', 'visual food cue reactivity', 'electroencephalogram and craving ratings', 'late positivity toward M&M pictures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",86.0,0.0227251,The results showed that imaginary eating did not reduce the appetitive value of M&M pictures.,"[{'ForeName': 'Saša', 'Initials': 'S', 'LastName': 'Zorjan', 'Affiliation': 'Clinical Psychology, University of Graz, BioTechMed, Graz, Austria; Department of Psychology, Faculty of Arts, University of Maribor, Slovenia.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Schwab', 'Affiliation': 'Clinical Psychology, University of Graz, BioTechMed, Graz, Austria.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schienle', 'Affiliation': 'Clinical Psychology, University of Graz, BioTechMed, Graz, Austria. Electronic address: anne.schienle@uni-graz.at.'}]",Appetite,['10.1016/j.appet.2020.104743']
927,31381020,Association of High-Dose Vitamin D Supplementation During Pregnancy With the Risk of Enamel Defects in Offspring: A 6-Year Follow-up of a Randomized Clinical Trial.,"Importance
Enamel defects of developmental origin affect up to 38% of schoolchildren and is recognized as a global public health challenge. The impaired enamel formation results in pain owing to hypersensitivity, posteruptive breakdowns, rapid caries progression, and extractions in some cases. The etiology is unknown; therefore, prevention is currently not possible.
Objective
To assess the association of a high-dose vitamin D supplementation in pregnant women with enamel defects and caries in their offspring.
Design, Setting, and Participants
Post hoc analysis of a double-blind, single-center, randomized clinical trial, the Copenhagen Prospective Studies on Asthma in Childhood 2010 cohort (COPSAC2010). Enrollment began March 2009 and included 623 women recruited at 24 weeks of pregnancy and 588 of their children. A dental examination was completed at age 6 years in 496 of 588 children (84%). Data were analyzed in 2018.
Intervention
High-dose vitamin D3 (2400 IU/d; N = 315) or matching placebo tablets (N = 308) from pregnancy week 24 to 1 week post partum. In addition, all women received 400 IU/d of vitamin D3 as part of standard care.
Main Outcomes and Measures
Enamel defect was defined as having at least 1 molar affected by demarcated opacity, enamel breakdown, and/or atypical restoration. Caries was defined as decayed, missing, or filled surfaces in both the deciduous and permanent dentitions (World Health Organization standard).
Results
The risk of enamel defects in the permanent dentition was lower in the offspring of mothers who received high-dose vitamin D supplementation during pregnancy compared with standard dose (15.1% [n = 26 of 172] vs 27.5% [n = 44 of 160]; odds ratio, 0.47; 95% CI, 0.27-0.81). A similar association was observed for the deciduous dentition (8.6% [n = 21 of 244] vs 15.9% [n = 40 of 252]; odds ratio, 0.50; 95% CI, 0.28-0.87). There was no association between supplementation and caries.
Conclusions and Relevance
High-dose vitamin D supplementation during pregnancy was associated with approximately 50% reduced odds of enamel defects in the offspring. This suggests prenatal vitamin D supplementation as a preventive intervention for enamel defects, with a clinically important association with dental health.
Trial Registration
ClinicalTrials.gov identifier: NCT00856947.",2019,"The risk of enamel defects in the permanent dentition was lower in the offspring of mothers who received high-dose vitamin D supplementation during pregnancy compared with standard dose (15.1% [n = 26 of 172] vs 27.5% [n = 44 of 160]; odds ratio, 0.47; 95% CI, 0.27-0.81).","['Offspring', 'A dental examination was completed at age 6 years in 496 of 588 children (84', 'Enrollment began March 2009 and included 623 women recruited at 24 weeks of pregnancy and 588 of their children', 'pregnant women with enamel defects and caries in their offspring']","['vitamin D supplementation', 'vitamin D3', 'High-Dose Vitamin D Supplementation', 'Intervention\n\n\nHigh-dose vitamin D3', 'matching placebo tablets', 'prenatal vitamin D supplementation']","['risk of enamel defects', 'deciduous dentition', 'Measures\n\n\nEnamel defect was defined as having at least 1 molar affected by demarcated opacity, enamel breakdown, and/or atypical restoration']","[{'cui': 'C0750862', 'cui_str': 'Dental examination'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0772413', 'cui_str': 'Prenatal vitamin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C1265876', 'cui_str': 'Abnormally opaque structure (morphologic abnormality)'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}]",623.0,0.505528,"The risk of enamel defects in the permanent dentition was lower in the offspring of mothers who received high-dose vitamin D supplementation during pregnancy compared with standard dose (15.1% [n = 26 of 172] vs 27.5% [n = 44 of 160]; odds ratio, 0.47; 95% CI, 0.27-0.81).","[{'ForeName': 'Pia Elisabeth', 'Initials': 'PE', 'LastName': 'Nørrisgaard', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Haubek', 'Affiliation': 'Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kühnisch', 'Affiliation': 'Department of Operative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-Universität München, München, Germany.'}, {'ForeName': 'Bo Lund', 'Initials': 'BL', 'LastName': 'Chawes', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Stokholm', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Bønnelykke', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Bisgaard', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte, Denmark.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.2545']
928,10768304,Topiramate as add-on therapy: pooled analysis of randomized controlled trials in adults.,"PURPOSE
Six double-blind, placebo-controlled trials were conducted with topiramate (TPM) initiated as adjunctive therapy in adults with treatment-resistant partial-onset seizures with or without secondary generalization.
METHODS
Because protocols and study populations were similar, data from the studies were pooled and analyzed for 527 patients treated with TPM and 216 treated with placebo.
RESULTS
Seizures were reduced > or =50% in 43% of TPM-treated patients and in 12% of placebo-treated patients (p < 0.001); 5% of TPM-treated patients, but no placebo-treated patients, were seizure free during 11-19 weeks of double-blind treatment (p < 0.001). The therapeutic effect was consistent regardless of seizure type, age, gender, baseline seizure rate, or concomitant antiepileptic drug (AED). With 100 mg/day TPM as a starting dosage and weekly dosage increments of 100-200 mg/day added to maximally tolerated dosages of AEDs, the most common treatment-emergent adverse events (TEAEs) were dizziness, somnolence, fatigue, psychomotor slowing, nervousness, paresthesia, ataxia, memory difficulty and speech problems. These central nervous system effects were generally mild to moderate in severity, usually occurred early in treatment, often during titration, and resolved with continued treatment. Other notable TEAEs were weight loss and, in a small percentage of patients, renal calculi.",2000,"RESULTS
Seizures were reduced > or =50% in 43% of TPM-treated patients and in 12% of placebo-treated patients (p < 0.001); 5% of TPM-treated patients, but no placebo-treated patients, were seizure free during 11-19 weeks of double-blind treatment (p < 0.001).","['adults with treatment-resistant partial-onset seizures with or without secondary generalization', 'Because protocols and study populations were similar, data from the studies were pooled and analyzed for 527 patients treated with TPM and 216 treated with', 'adults']","['Topiramate', 'placebo', 'topiramate (TPM']","['seizure free', 'dizziness, somnolence, fatigue, psychomotor slowing, nervousness, paresthesia, ataxia, memory difficulty and speech problems', 'Seizures', 'weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0017324', 'cui_str': 'Generalization'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C4517805', 'cui_str': 'Five hundred and twenty-seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}]","[{'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0004134', 'cui_str': 'Dyssynergia'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0395016', 'cui_str': 'Speech problem (finding)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.416205,"RESULTS
Seizures were reduced > or =50% in 43% of TPM-treated patients and in 12% of placebo-treated patients (p < 0.001); 5% of TPM-treated patients, but no placebo-treated patients, were seizure free during 11-19 weeks of double-blind treatment (p < 0.001).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Reife', 'Affiliation': 'The R. W. Johnson Pharmaceutical Research Institute, Raritan, New Jersey 08869-0602, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pledger', 'Affiliation': ''}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Wu', 'Affiliation': ''}]",Epilepsia,[]
929,31427204,"Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomised, controlled, phase 3 trial.","BACKGROUND
In the ongoing phase 3 CheckMate 214 trial, nivolumab plus ipilimumab showed superior efficacy over sunitinib in patients with previously untreated intermediate-risk or poor-risk advanced renal cell carcinoma, with a manageable safety profile. In this study, we aimed to assess efficacy and safety after extended follow-up to inform the long-term clinical benefit of nivolumab plus ipilimumab versus sunitinib in this setting.
METHODS
In the phase 3, randomised, controlled CheckMate 214 trial, patients aged 18 years and older with previously untreated, advanced, or metastatic histologically confirmed renal cell carcinoma with a clear-cell component were recruited from 175 hospitals and cancer centres in 28 countries. Patients were categorised by International Metastatic Renal Cell Carcinoma Database Consortium risk status into favourable-risk, intermediate-risk, and poor-risk subgroups and randomly assigned (1:1) to open-label nivolumab (3 mg/kg intravenously) plus ipilimumab (1 mg/kg intravenously) every 3 weeks for four doses, followed by nivolumab (3 mg/kg intravenously) every 2 weeks; or sunitinib (50 mg orally) once daily for 4 weeks (6-week cycle). Randomisation was done through an interactive voice response system, with a block size of four and stratified by risk status and geographical region. The co-primary endpoints for the trial were overall survival, progression-free survival per independent radiology review committee (IRRC), and objective responses per IRRC in intermediate-risk or poor-risk patients. Secondary endpoints were overall survival, progression-free survival per IRRC, and objective responses per IRRC in the intention-to-treat population, and adverse events in all treated patients. In this Article, we report overall survival, investigator-assessed progression-free survival, investigator-assessed objective response, characterisation of response, and safety after extended follow-up. Efficacy outcomes were assessed in all randomly assigned patients; safety was assessed in all treated patients. This study is registered with ClinicalTrials.gov, number NCT02231749, and is ongoing but now closed to recruitment.
FINDINGS
Between Oct 16, 2014, and Feb 23, 2016, of 1390 patients screened, 1096 (79%) eligible patients were randomly assigned to nivolumab plus ipilimumab or sunitinib (550 vs 546 in the intention-to-treat population; 425 vs 422 intermediate-risk or poor-risk patients, and 125 vs 124 favourable-risk patients). With extended follow-up (median follow-up 32·4 months [IQR 13·4-36·3]), in intermediate-risk or poor-risk patients, results for the three co-primary efficacy endpoints showed that nivolumab plus ipilimumab continued to be superior to sunitinib in terms of overall survival (median not reached [95% CI 35·6-not estimable] vs 26·6 months [22·1-33·4]; hazard ratio [HR] 0·66 [95% CI 0·54-0·80], p<0·0001), progression-free survival (median 8·2 months [95% CI 6·9-10·0] vs 8·3 months [7·0-8·8]; HR 0·77 [95% CI 0·65-0·90], p=0·0014), and the proportion of patients achieving an objective response (178 [42%] of 425 vs 124 [29%] of 422; p=0·0001). Similarly, in intention-to-treat patients, nivolumab and ipilimumab showed improved efficacy compared with sunitinib in terms of overall survival (median not reached [95% CI not estimable] vs 37·9 months [32·2-not estimable]; HR 0·71 [95% CI 0·59-0·86], p=0·0003), progression-free survival (median 9·7 months [95% CI 8·1-11·1] vs 9·7 months [8·3-11·1]; HR 0·85 [95% CI 0·73-0·98], p=0·027), and the proportion of patients achieving an objective response (227 [41%] of 550 vs 186 [34%] of 546 p=0·015). In all treated patients, the most common grade 3-4 treatment-related adverse events in the nivolumab and ipilimumab group were increased lipase (57 [10%] of 547), increased amylase (31 [6%]), and increased alanine aminotransferase (28 [5%]), whereas in the sunitinib group they were hypertension (90 [17%] of 535), fatigue (51 [10%]), and palmar-plantar erythrodysaesthesia (49 [9%]). Eight deaths in the nivolumab plus ipilimumab group and four deaths in the sunitinib group were reported as treatment-related.
INTERPRETATION
The results suggest that the superior efficacy of nivolumab plus ipilimumab over sunitinib was maintained in intermediate-risk or poor-risk and intention-to-treat patients with extended follow-up, and show the long-term benefits of nivolumab plus ipilimumab in patients with previously untreated advanced renal cell carcinoma across all risk categories.
FUNDING
Bristol-Myers Squibb and ONO Pharmaceutical.",2019,"HR 0·77 [95% CI 0·65-0·90], p=0·0014), and the proportion of patients achieving an objective response (178 [42%] of 425 vs 124 [29%] of 422; p=0·0001).","['patients aged 18 years and older with previously untreated, advanced, or metastatic histologically confirmed renal cell carcinoma with a clear-cell component were recruited from 175 hospitals and cancer centres in 28 countries', 'Patients were categorised by International Metastatic Renal Cell Carcinoma Database Consortium risk status into favourable-risk, intermediate-risk, and poor-risk subgroups and randomly assigned (1:1) to', 'advanced renal cell carcinoma', 'patients with previously untreated advanced renal cell carcinoma across all risk categories', 'Between Oct 16, 2014, and Feb 23, 2016, of 1390 patients screened, 1096 (79%) eligible patients', 'patients with previously untreated intermediate-risk or poor-risk advanced renal cell carcinoma']","['nivolumab plus ipilimumab or sunitinib', 'Nivolumab plus ipilimumab versus sunitinib', 'open-label nivolumab (3 mg/kg intravenously) plus ipilimumab', 'sunitinib', 'nivolumab plus ipilimumab']","['Efficacy outcomes', 'fatigue', 'alanine aminotransferase', 'overall survival, progression-free survival per independent radiology review committee (IRRC), and objective responses per IRRC in intermediate-risk or poor-risk patients', 'overall survival', 'adverse events', 'increased amylase', 'progression-free survival', 'overall survival, progression-free survival per IRRC, and objective responses per IRRC in the intention-to-treat population, and adverse events', 'progression-free survival ', 'efficacy', 'efficacy and safety', 'hypertension', 'palmar-plantar erythrodysaesthesia', 'proportion of patients achieving an objective response', 'overall survival, investigator-assessed progression-free survival, investigator-assessed objective response, characterisation of response, and safety', 'lipase']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517571', 'cui_str': '1390 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0034599', 'cui_str': 'Radiology'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0201883', 'cui_str': 'Amylase measurement (procedure)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1184147', 'cui_str': 'Palmar (qualifier value)'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}]",1390.0,0.285576,"HR 0·77 [95% CI 0·65-0·90], p=0·0014), and the proportion of patients achieving an objective response (178 [42%] of 425 vs 124 [29%] of 422; p=0·0001).","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: motzerr@mskcc.org.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Department of Hematology and Medical Oncology, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Osvaldo', 'Initials': 'O', 'LastName': 'Arén Frontera', 'Affiliation': 'Department of Medical Oncology, Centro de Invetigación Clínica Bradford Hill, Santiago, Chile.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Hammers', 'Affiliation': 'Department of Oncology and Urology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Department of Oncology and Urology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Salman', 'Affiliation': 'Department of Medical Oncology, Fundación Arturo López Pérez, Santiago, Chile.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Beuselinck', 'Affiliation': 'Department of Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Levine Cancer Institute, Atrium Healthcare, Charlotte, NC, USA.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Department of Medical Oncology, IRCCS San Matteo University Hospital Foundation, Pavia, Italy.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Neiman', 'Affiliation': 'Department of Oncology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel; Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Department of Oncology, Ospedale San Donato, Azienda USL Toscana Sud-Est, IstitutoToscanoTumori, Arezzo, Italy.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Tykodi', 'Affiliation': 'Department of Medicine, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Barthélémy', 'Affiliation': 'Department of Medical Oncology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Raya', 'Initials': 'R', 'LastName': 'Leibowitz-Amit', 'Affiliation': 'Oncology Department, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Department of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Sjoukje F', 'Initials': 'SF', 'LastName': 'Oosting', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Redman', 'Affiliation': 'Department of Internal Medicine, Division of Hematology and Oncology, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.'}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Department of Oncology, Palacky University, and University Hospital Olomouc, Olomouc, Czech Republic.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Department of Genitourinary Oncology, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, Royal Free National Health Service Trust, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nathan', 'Affiliation': 'Department of Cancer Services: Oncology, Mount Vernon Cancer Centre, Northwood, Middlesex, UK.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Department of Medical Oncology, Service de Cancérologie Médicale Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pook', 'Affiliation': 'Department of Oncology, Monash Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Department of Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Department of Urology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Department of Medical Oncology, Westmead Hospital and Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Daniel Y C', 'Initials': 'DYC', 'LastName': 'Heng', 'Affiliation': 'Department of Oncology, Tom Baker Cancer Center, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Kollmannsberger', 'Affiliation': 'Department of Medicine, British Columbia Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Harrison', 'Affiliation': 'Division of Medical Oncology, Duke Cancer Institute, Durham, NC, USA.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Department of Urology, Niigata University, Niigata, Japan.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Duran', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Interdisciplinary Genitourinary Oncology at the West-German Cancer Center, Clinic for Internal Medicine (Tumor Research) and Clinic for Urology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Sabeen', 'Initials': 'S', 'LastName': 'Mekan', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30413-9']
930,31422028,Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis.,"BACKGROUND
Phase 3 clinical data has shown higher proportions of patients with objective response, longer response duration, and longer overall survival with nivolumab versus docetaxel in patients with previously treated advanced non-small-cell lung cancer (NSCLC). We aimed to evaluate the long-term benefit of nivolumab and the effect of response and disease control on subsequent survival.
METHODS
We pooled data from four clinical studies of nivolumab in patients with previously treated NSCLC (CheckMate 017, 057, 063, and 003) to evaluate survival outcomes. Trials of nivolumab in the second-line or later setting with at least 4 years follow-up were included. Comparisons of nivolumab versus docetaxel included all randomised patients from the phase 3 CheckMate 017 and 057 studies. We did landmark analyses by response status at 6 months to determine post-landmark survival outcomes. We excluded patients who did not have a radiographic tumour assessment at 6 months. Safety analyses included all patients who received at least one dose of nivolumab.
FINDINGS
Across all four studies, 4-year overall survival with nivolumab was 14% (95% CI 11-17) for all patients (n=664), 19% (15-24) for those with at least 1% PD-L1 expression, and 11% (7-16) for those with less than 1% PD-L1 expression. In CheckMate 017 and 057, 4-year overall survival was 14% (95% CI 11-18) in patients treated with nivolumab, compared with 5% (3-7) in patients treated with docetaxel. Survival subsequent to response at 6 months on nivolumab or docetaxel was longer than after progressive disease at 6 months, with hazard ratios for overall survival of 0·18 (95% 0·12-0·27) for nivolumab and 0·43 (0·29-0·65) for docetaxel; for stable disease versus progressive disease, hazard ratios were 0·52 (0·37-0·71) for nivolumab and 0·80 (0·61-1·04) for docetaxel. Long-term data did not show any new safety signals.
INTERPRETATION
Patients with advanced NSCLC treated with nivolumab achieved a greater duration of response compared with patients treated with docetaxel, which was associated with a long-term survival advantage.
FUNDING
Bristol-Myers Squibb.",2019,"Survival subsequent to response at 6 months on nivolumab or docetaxel was longer than after progressive disease at 6 months, with hazard ratios for overall survival of 0·18 (95% 0·12-0·27) for nivolumab and 0·43 (0·29-0·65) for docetaxel; for stable disease versus progressive disease, hazard ratios were 0·52","['patients with previously treated advanced non-small-cell lung cancer (NSCLC', 'patients from the phase 3 CheckMate 017 and 057 studies', 'patients who did not have a radiographic tumour assessment at 6 months', 'patients with previously treated advanced non-small-cell lung cancer', 'patients who received at least one dose of nivolumab', 'patients with previously treated NSCLC (CheckMate 017, 057, 063, and 003', 'Trials of nivolumab in the second-line or later setting with at least 4 years follow-up were included']","['docetaxel', 'nivolumab versus docetaxel', 'nivolumab or docetaxel', 'nivolumab']","['survival outcomes', 'duration of response', '4-year overall survival with nivolumab', '4-year overall survival', 'Survival subsequent to response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]",664.0,0.50406,"Survival subsequent to response at 6 months on nivolumab or docetaxel was longer than after progressive disease at 6 months, with hazard ratios for overall survival of 0·18 (95% 0·12-0·27) for nivolumab and 0·43 (0·29-0·65) for docetaxel; for stable disease versus progressive disease, hazard ratios were 0·52","[{'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA. Electronic address: scott.antonia@duke.edu.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Borghaei', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'De Castro Carpeño', 'Affiliation': 'Centro Integral Oncológico Clara Campal, Madrid, Spain.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pluzanski', 'Affiliation': 'Klinika Nowotworow Pluca i Klatki Piersiowej, Centrum Onkologii-Instytut Im Marii Sklodowskiej-Curie, Warsaw, Poland.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Burgio', 'Affiliation': 'Medical Oncology Unit, Istituto Scientifico Romagnolo Per lo Studio e la Cura dei Tumori (IRST) IRCSS, Meldola, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Garassino', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Laura Q M', 'Initials': 'LQM', 'LastName': 'Chow', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Gettinger', 'Affiliation': 'Yale Cancer Center, New Haven, CT, USA.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Crinò', 'Affiliation': 'Medical Oncology Unit, Istituto Scientifico Romagnolo Per lo Studio e la Cura dei Tumori (IRST) IRCSS, Meldola, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Institut Gustave Roussy, Department of Medical Oncology, Thoracic Group, Villejuif, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Butts', 'Affiliation': 'Department of Oncology, Division of Medical Oncology, Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Drilon', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wojcik-Tomaszewska', 'Affiliation': 'Wojewodzkie Centrum Onkologii, Gdańsk, Poland.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Otterson', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Penrod', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brahmer', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30407-3']
931,32139102,Does negative pressure wound therapy with irrigation improve clinical outcomes? A randomized clinical trial in patients with diabetic foot infections.,"AIM
To compare the efficacy of Negative Pressure Wound Therapy (NPWT) with and without irrigation with 0.1% polyhexanide-betaine.
METHODS
We randomized 150 subjects in a 16-week RCT to compare healing in patients with diabetic foot infections. NPWT delivered at 125 mm Hg continuous pressure. NPWT-I were administered at 30 cc per hour.
RESULTS
There were no differences clinical treatment or outcomes: wound area after surgery (18.5 ± 19.0 vs. 13.4 ± 11.1 cm2, p = 0.50), duration of antibiotics (39.7 ± 21.0 vs. 38.0 ± 24.6 days, p = 0.40), number of surgeries (2.3 ± 0.67 vs. 2.2 ± 0.59, p = 0.85), duration of NPWT (148.1 ± 170.4 vs. 114.5 ± 135.1 h, p = 0.06), healed wounds (58.7% vs. 60.0%, p = 0.86), time to healing (56.3 ± 31.7 vs. 50.7 ± 27.8, p = 0.53), length of stay (13.8 ± 6.4 vs. 14.5 ± 11.2 days, p = 0.42), re-infection (20.0% vs. 22.7%, p = 0.69, and re-hospitalization (17.3% vs. 18.7, p = 0.83).
CONCLUSIONS
The addition of irrigation to NPWT did not change clinical outcomes in patients with diabetic foot infections.
CLINICAL TRIAL NUMBER
NCT02463487, ClinicalTrials.gov.",2020,There were no differences clinical treatment or outcomes: wound area after surgery (18.5 ± ,"['150 subjects in a 16-week', 'patients with diabetic foot infections']","['Negative Pressure Wound Therapy (NPWT', 'NPWT', 'RCT']","['number of surgeries', 'healed wounds', 're-hospitalization', 'length of stay', 'time to healing', 'duration of NPWT', 're-infection', 'duration of antibiotics', 'outcomes: wound area after surgery (18.5\xa0±']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0744130', 'cui_str': 'Diabetic foot infection'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1265679', 'cui_str': 'Wound, healed'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}]",150.0,0.201532,There were no differences clinical treatment or outcomes: wound area after surgery (18.5 ± ,"[{'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Lavery', 'Affiliation': 'Department of Plastic Surgery, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75219, USA. Electronic address: larry.lavery@utsouthwestern.edu.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Davis', 'Affiliation': 'Department of Plastic Surgery, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75219, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'La Fontaine', 'Affiliation': 'Department of Plastic Surgery, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75219, USA.'}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Farrar', 'Affiliation': 'Department of Immunology and Molecular Biology, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75219, USA.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Bhavan', 'Affiliation': 'Department of Internal Medicine, Infectious Disease University of Texas Southwestern Medical 5323 Harry Hines Blvd, Dallas, 75219, Texas, USA.'}, {'ForeName': 'Orhan K', 'Initials': 'OK', 'LastName': 'Oz', 'Affiliation': 'Department of Radiology, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75219, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Crisologo', 'Affiliation': 'Department of Plastic Surgery, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75219, USA; Department of Surgery, University of Cincinnati Medical Center, 231 Albert Sabin Way, ML 0513, Cincinnati, OH 45267, USA. Electronic address: crisolpa@ucmail.uc.edu.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.02.044']
932,32134436,Effects of Cataract Surgery on Melatonin Secretion in Adults 60 Years and Older: A Randomized Clinical Trial.,"Importance
Cataract surgery, which increases perception of light, may increase melatonin secretion. Melatonin secretion has been associated with depression, diabetes, cognitive impairment, and breast cancer. To date, no evidence from a randomized clinical trial exists to support this cataract surgery hypothesis.
Objective
To determine whether cataract surgery modifies the melatonin secretion at 3 months after cataract surgery in 169 adult patients.
Design, Setting, and Participants
A parallel-group randomized clinical trial was conducted at a single referral center from July 1, 2014, to June 30, 2017. Data were analyzed from January 1, 2018, to March 31, 2019. Patients were aged 60 years or older, had no history of cataract surgery, and had cataracts with grade 2 or higher nuclear opacifications based on the Lens Opacities Classification System III. Analyses were based on intention to treat.
Interventions
Patients were randomized 1:1:1:1 to receive cataract surgery using artificial clear intraocular lens (IOL) or yellow IOL. Group 1 received prompt surgery with clear IOL, group 2, prompt surgery with yellow IOL, group 3, delayed surgery with clear IOL, and group 4, delayed surgery with yellow IOL. The intervention group consisted of groups 1 and 2, and the control group consisted of groups 3 and 4.
Main Outcomes and Measures
Urinary melatonin excretion in the intervention group was measured at 3 months after surgery, and urinary melatonin excretion in the control group was measured before delayed surgery.
Results
Of the 169 randomized patients, 97 were men (57.4%). The mean (SD) age was 75.7 (6.7) years. Mean urinary melatonin excretion was calculated as standardized urinary concentration, the ratio of urinary concentration to urinary creatinine concentration (nanograms per milligram of creatinine), in the intervention group after cataract surgery. Mean urinary melatonin excretion was significantly higher than in the control group (adjusted mean difference of creatinine concentration, 0.159 log ng/mg, 95% CI, 0.045-0.273; P = .007) independent of baseline urinary melatonin excretion and potential confounders. Subgroup analysis comparing group 1 with group 3 revealed that concentration of urinary melatonin excretion in patients who received clear IOLs was higher than the control group by creatinine concentration 0.212 log ng/mg (95% CI of the difference, 0.058-0.365; P = .008). However, the difference between patients in group 2 and group 4 was not significant (adjusted mean difference for creatinine excretion, 0.083 log ng/mg, 95% CI, -0.087 to 0.253; P = .33). The difference of concentration of mean urinary melatonin excretion between patients in group 1 and those in group 2 was not significant (95% CI of the difference for creatinine concentration, -0.19 to 0.40 log ng/mg; P = .48).
Conclusions and Relevance
The findings in this study support the hypothesis that cataract surgery increases melatonin secretion. The effect of clear IOLs vs yellow IOLs on these outcomes was not shown to be different.
Trial Registration
UMIN-CTR Identifier: UMIN000014559.",2020,"Mean urinary melatonin excretion was significantly higher than in the control group (adjusted mean difference of creatinine concentration, 0.159 log ng/mg, 95% CI, 0.045-0.273; P = .007) independent of baseline urinary melatonin excretion and potential confounders.","['169 randomized patients, 97 were men (57.4', 'Patients were aged 60 years or older, had no history of cataract surgery, and had cataracts with grade 2 or higher nuclear opacifications based on the Lens Opacities Classification System III', 'Adults 60 Years and Older', '169 adult patients']","['cataract surgery using artificial clear intraocular lens (IOL) or yellow IOL', 'cataract surgery', 'prompt surgery with clear IOL, group 2, prompt surgery with yellow IOL, group 3, delayed surgery with clear IOL, and group 4, delayed surgery with yellow IOL', 'Melatonin secretion', 'Cataract Surgery']","['Melatonin Secretion', 'concentration of urinary melatonin excretion', 'melatonin secretion', 'Measures\n\n\nUrinary melatonin excretion', 'creatinine excretion', 'urinary melatonin excretion', 'Mean urinary melatonin excretion', 'concentration of mean urinary melatonin excretion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449584', 'cui_str': 'Opacification (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C0221205', 'cui_str': 'Yellow color (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",169.0,0.200729,"Mean urinary melatonin excretion was significantly higher than in the control group (adjusted mean difference of creatinine concentration, 0.159 log ng/mg, 95% CI, 0.045-0.273; P = .007) independent of baseline urinary melatonin excretion and potential confounders.","[{'ForeName': 'Tomo', 'Initials': 'T', 'LastName': 'Nishi', 'Affiliation': 'Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Saeki', 'Affiliation': 'Department of Epidemiology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Kimie', 'Initials': 'K', 'LastName': 'Miyata', 'Affiliation': 'Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Tadanobu', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Kurumatani', 'Affiliation': 'Department of Epidemiology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Obayashi', 'Affiliation': 'Department of Epidemiology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Nahoko', 'Initials': 'N', 'LastName': 'Ogata', 'Affiliation': 'Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.0206']
933,31804580,Randomized Trial of Mindfulness-Based Stress Reduction in Cardiac Patients Eligible for Cardiac Rehabilitation.,"Currently, exercise-based cardiac rehabilitation (CR) is the only recommended secondary prevention strategy for cardiac patients that attempts to tackle stress and psychosocial wellbeing, but it is under-utilized and lacks a comprehensive curriculum for this purpose; hence there is a critical gap to address psychosocial needs of cardiac patients after an event. Mindfulness-based stress reduction (MBSR) has shown benefits in the general population but its role in cardiac patients is not clear. We conducted a pilot randomized controlled trial (RCT) of MBSR in CR-eligible cardiac patients during their initial year of recovery. Patients were allocated 2:1 (intervention:control) to an 8-week MBSR group intervention or usual care. Standard measures of depression, anxiety, perceived stress, health related quality of life (HRQOL), blood pressure, biomarkers (lipids, HbA1c, CRP) and 24-hour Holter monitoring were obtained at baseline, 3- and 9-months post-randomization. Sub-group analyses were performed for participants with at least mild depression (PHQ-9 ≥ 5). 47 patients [mean age 58.6 years; 38% female; 77% white] were enrolled in 2 cohorts. 87% of MBSR patients completed the intervention; study retention was >95% at each follow-up visit. At 3 months, compared to controls, MBSR patients showed improvements in depression [p = 0.01] and anxiety [p = 0.04] with a similar trend in HRQOL [p = 0.06]. The MBSR group showed greater improvement or less worsening of most CV risk factors, with an attenuation of treatment effects at 9 months. Participants with at PHQ-9 scores ≥5 at baseline showed greater improvement in psychosocial and CV outcomes, that persisted at 9 months. MBSR is a safe and well received secondary prevention strategy. This pilot RCT provides preliminary evidence of MBSR's potential to improve short term psychosocial well-being in cardiac patients during their first year of recovery.",2019,This pilot RCT provides preliminary evidence of MBSR's potential to improve short term psychosocial well-being in cardiac patients during their first year of recovery.,"['Cardiac Patients Eligible for Cardiac Rehabilitation', 'participants with at least mild depression (PHQ-9\u2009≥\u20095', 'CR-eligible cardiac patients during their initial year of recovery', '47 patients [mean age 58.6 years; 38% female; 77% white']","['MBSR group intervention or usual care', 'MBSR', 'Mindfulness-Based Stress Reduction', 'Mindfulness-based stress reduction (MBSR', 'exercise-based cardiac rehabilitation (CR']","['depression, anxiety, perceived stress, health related quality of life (HRQOL), blood pressure, biomarkers (lipids, HbA1c, CRP) and 24-hour Holter monitoring', 'worsening of most CV risk factors', 'depression', 'psychosocial and CV outcomes', 'anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0588006', 'cui_str': 'Mild depression (disorder)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0013801', 'cui_str': 'Monitoring, Holter'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",47.0,0.0623392,This pilot RCT provides preliminary evidence of MBSR's potential to improve short term psychosocial well-being in cardiac patients during their first year of recovery.,"[{'ForeName': 'Prabhjot S', 'Initials': 'PS', 'LastName': 'Nijjar', 'Affiliation': 'Cardiovascular Division, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA. nijja003@umn.edu.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Connett', 'Affiliation': 'Biostatistics, Epidemiology and Research Design (BERD), University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lindquist', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'Biostatistics, Epidemiology and Research Design (BERD), University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Burt', 'Affiliation': 'Cardiac Rehabilitation, Fairview Health Services, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Pergolski', 'Affiliation': 'Cardiac Rehabilitation, Fairview Health Services, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Wolfe', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Balaji', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Chandiramani', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Kreitzer', 'Affiliation': 'Earl E Bakken Center for Spirituality & Healing, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Everson-Rose', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}]",Scientific reports,['10.1038/s41598-019-54932-2']
934,32139110,"Metabolome and microbiome alterations related to short-term feeding of a micronutrient-fortified, high-quality legume protein-based food product to stunted school age children: A randomized controlled pilot trial.","BACKGROUND & AIMS
Stunting in children is a comorbid condition in undernutrition that may be ameliorated by the provision of high-quality foods that provide protein and micronutrients. Addressing this problem in lower social economic environments requires, in part, affordable and scalable food-based solutions with efficacious food products. Towards this end, biochemical/metabolic indicators for fast-throughput screening of foods and their components are desired. A highly acceptable and economical micronutrient-fortified food product with different levels of legume protein was provided to stunted Indian children for one month, to determine change in their linear growth and explore associated biochemical, metabolomic and microbiome indicators.
METHODS
A randomized controlled pilot trial was conducted with 100 stunted children (6-10 years of age) to elucidate metabolic and microbiome-based biomarkers associated with linear growth. They were randomized into 4 groups receiving 6, 8, 10 or 12 g of legume-based protein for one month. Anthropometry, blood biochemistry, aminoacidomics, acylcarnitomics and fecal microbiome were measured before and after feeding.
RESULTS
No significant differences were observed between groups in height, height-for-age Z-score (HAZ) or BMI-for-age Z-score (BAZ); however, 38 serum metabolites were altered significantly (Bonferroni adjusted P < 0.1) in response to the interventions. IGF-1 (Insulin like Growth Factor-1) was positively (ρ > 0.2, P = 0.02), while serine and ornithine (ρ < -0.2, P = 0.08) were negatively associated with change in height. Leucine, isoleucine and valine positively correlated (P = 0.011, 0.023 and 0.007 respectively) with change in BAZ. Three Operational Taxonomic Units belonging to Bacteroidetes and Firmicutes (VIP score > 1.5) were significantly correlated with change in height.
CONCLUSIONS
In this pilot trial, a number of fasting serum metabolomic and fecal microbiome signatures were associated with linear growth after a short-term dietary intervention. The alterations of these markers should be validated in long-term dietary intervention trials as potential screening indicators towards the development of food products that favor growth. This trial was registered at www.ctri.nic.in as CTRI/2016/12/007564.",2020,"No significant differences were observed between groups in height, height-for-age Z-score (HAZ) or BMI-for-age Z-score (BAZ); however, 38 serum metabolites were altered significantly (Bonferroni adjusted P < 0.1) in response to the interventions.","['100 stunted children (6-10 years of age) to elucidate metabolic and microbiome-based biomarkers associated with linear growth', 'stunted school age children']","['micronutrient-fortified, high-quality legume protein-based food product', 'IGF-1']","['Insulin like Growth Factor-1', 'Anthropometry, blood biochemistry, aminoacidomics, acylcarnitomics and fecal microbiome', 'height, height-for-age Z-score (HAZ) or BMI-for-age Z-score (BAZ']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0453184', 'cui_str': 'Legumes'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005768'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",100.0,0.0752519,"No significant differences were observed between groups in height, height-for-age Z-score (HAZ) or BMI-for-age Z-score (BAZ); however, 38 serum metabolites were altered significantly (Bonferroni adjusted P < 0.1) in response to the interventions.","[{'ForeName': 'Aneesia', 'Initials': 'A', 'LastName': 'Varkey', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, St. John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Devi', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, St. John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Arpita', 'Initials': 'A', 'LastName': 'Mukhopadhyay', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, St. John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Namrata G', 'Initials': 'NG', 'LastName': 'Kamat', 'Affiliation': ""Division of Epidemiology, Biostatistics and Population Health, St. John's Research Institute, St. John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pauline', 'Affiliation': ""Department of Physiology, St. John's Medical College, St. John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Madan', 'Initials': 'M', 'LastName': 'Dharmar', 'Affiliation': 'Betty Irene Moore School of Nursing and the Department of Pediatrics, University of California, Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Roberta R', 'Initials': 'RR', 'LastName': 'Holt', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA.'}, {'ForeName': 'Lindsay H', 'Initials': 'LH', 'LastName': 'Allen', 'Affiliation': 'United States Department of Agriculture, Agricultural Research Service, Western Human Nutrition Research Center, Davis, CA, USA.'}, {'ForeName': 'Tinku', 'Initials': 'T', 'LastName': 'Thomas', 'Affiliation': ""Department of Biostatistics, St. John's Medical College, St. John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Carl L', 'Initials': 'CL', 'LastName': 'Keen', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA. Electronic address: clkeen@ucdavis.edu.'}, {'ForeName': 'Anura V', 'Initials': 'AV', 'LastName': 'Kurpad', 'Affiliation': ""Department of Physiology, St. John's Medical College, St. John's National Academy of Health Sciences, Bangalore, India. Electronic address: a.kurpad@sjri.res.in.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.02.018']
935,31424391,Self and Informant Memory Reports in FINGER: Associations with Two-Year Cognitive Change.,"BACKGROUND
Subjective memory complaints (SMCs) may be the first sign of cognitive decline in aging.
OBJECTIVE
To examine whether SMCs reported by oneself and informant predict cognitive change over 2 years among at-risk elderly people, and to determine the relationship of different types of SMCs (prospective and retrospective memory complaints) and change in cognitive function.
METHODS
This investigation is part of the FINGER project, which is a multicenter randomized controlled trial aiming at preventing cognitive decline in cognitively healthy older adults with increased risk of dementia. A subsample of 303 control-group participants (aged 60-80 years) and their informants (n = 261) rated the frequency of SMCs, using the Prospective and Retrospective Memory Questionnaire (PRMQ). Cognitive performance was measured at baseline and at 1- and 2-year follow-up visits using a neuropsychological test battery.
RESULTS
Participants who reported more SMCs improved less in global cognition, executive function, and memory during the subsequent 2 years in the fully-adjusted analyses. Self-reported retrospective memory problems predicted less improvement in all cognitive domains, whereas prospective memory problems did not. Informant-reported memory problems were not linked to subsequent change in cognition.
CONCLUSION
Our results indicate that self-reported SMCs, measured with PRMQ, predict future cognitive change in several cognitive domains. By contrast, reports by informants were not linked to changes in cognition. Among cognitively healthy at-risk elderly individuals, the persons themselves observe more easily problems relevant for their future cognitive trajectories than their informants.",2019,"RESULTS
Participants who reported more SMCs improved less in global cognition, executive function, and memory during the subsequent 2 years in the fully-adjusted analyses.","['cognitively healthy older adults with increased risk of dementia', 'cognitively healthy at-risk elderly individuals', 'A subsample of 303 control-group participants (aged 60-80 years) and their informants (n\u200a=\u200a261) rated the frequency of SMCs, using the Prospective and Retrospective Memory Questionnaire (PRMQ', 'FINGER']",['SMCs'],"['global cognition, executive function, and memory', 'Cognitive performance']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0218107,"RESULTS
Participants who reported more SMCs improved less in global cognition, executive function, and memory during the subsequent 2 years in the fully-adjusted analyses.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vaskivuo', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hokkanen', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Tuomo', 'Initials': 'T', 'LastName': 'Hänninen', 'Affiliation': 'Neurocenter/ Neurology, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Antikainen', 'Affiliation': 'University of Oulu, Center for Life Course Health Research, Oulu, Finland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bäckman', 'Affiliation': 'Aging Research Center, Karolinska Institutet-Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Laatikainen', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Paajanen', 'Affiliation': 'Finnish Institute of Occupational Health, Helsinki, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Stigsdotter-Neely', 'Affiliation': 'Department of Psychology, Umeå University, Umeå, Sweden and Department of Social and Psychological Sciences, Karlstad University, Karlstad, Sweden.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Strandberg', 'Affiliation': 'University of Oulu, Center for Life Course Health Research, Oulu, Finland.'}, {'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Tuomilehto', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Hilkka', 'Initials': 'H', 'LastName': 'Soininen', 'Affiliation': 'Neurocenter/ Neurology, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Kivipelto', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Tiia', 'Initials': 'T', 'LastName': 'Ngandu', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190133']
936,32139550,Substantial and sustained improvement of serrated polyp detection after a simple educational intervention: results from a prospective controlled trial.,"OBJECTIVE
Serrated polyps (SPs) are an important cause of postcolonoscopy colorectal cancers (PCCRCs), which is likely the result of suboptimal SP detection during colonoscopy. We assessed the long-term effect of a simple educational intervention focusing on optimising SP detection.
DESIGN
An educational intervention, consisting of two 45 min training sessions (held 3 years apart) on serrated polyp detection, was given to endoscopists from 9 Dutch hospitals. Hundred randomly selected and untrained endoscopists from other hospitals were selected as control group. Our primary outcome measure was the proximal SP detection rate (PSPDR) in trained versus untrained endoscopists who participated in our faecal immunochemical test (FIT)-based population screening programme.
RESULTS
Seventeen trained and 100 untrained endoscopists were included, who performed 11 305 and 51 039 colonoscopies, respectively. At baseline, PSPDR was equal between the groups (9.3% vs 9.3%). After training, the PSPDR of trained endoscopists gradually increased to 15.6% in 2018. This was significantly higher than the PSPDR of untrained endoscopists, which remained stable around 10% (p=0.018). All below-average (ie, PSPDR ≤6%) endoscopists at baseline improved their PSPDR after training session 1, as did 57% of endoscopists with average PSPDR (6%-12%) at baseline. The second training session further improved the PSPDR in 44% of endoscopists with average PSPDR after the first training.
CONCLUSION
A simple educational intervention was associated with substantial long-term improvement of PSPDR in a prospective controlled trial within FIT-based population screening. Widespread implementation of such interventions might be an easy way to improve SP detection, which may ultimately result in fewer PCCRCs.
TRIAL REGISTRATION NUMBER
NCT03902899.",2020,"The second training session further improved the PSPDR in 44% of endoscopists with average PSPDR after the first training.
","['Seventeen trained and 100 untrained endoscopists were included, who performed 11\u2009305 and 51\u2009039 colonoscopies, respectively', 'Hundred randomly selected and untrained endoscopists from other hospitals were selected as control group']",['simple educational intervention'],"['PSPDR of trained endoscopists', 'proximal SP detection rate (PSPDR', 'PSPDR']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}]",0.0,0.0346153,"The second training session further improved the PSPDR in 44% of endoscopists with average PSPDR after the first training.
","[{'ForeName': 'Arne G C', 'Initials': 'AGC', 'LastName': 'Bleijenberg', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Monique E', 'Initials': 'ME', 'LastName': 'van Leerdam', 'Affiliation': 'Department of Gastroenterology and Hepatology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Bargeman', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Jan Jacob', 'Initials': 'JJ', 'LastName': 'Koornstra', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Yasmijn J', 'Initials': 'YJ', 'LastName': 'van Herwaarden', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Manon Cw', 'Initials': 'MC', 'LastName': 'Spaander', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Sanduleanu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Barbara A J', 'Initials': 'BAJ', 'LastName': 'Bastiaansen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Schoon', 'Affiliation': 'Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Lelyveld', 'Affiliation': 'Department of Gastroenterology and Hepatology, Saint Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Dekker', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands e.dekker@amsterdamumc.nl.'}, {'ForeName': 'Joep E G', 'Initials': 'JEG', 'LastName': 'IJspeert', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",Gut,['10.1136/gutjnl-2019-319804']
937,31424399,An Indoor Therapeutic Garden for Behavioral Symptoms in Alzheimer's Disease: A Randomized Controlled Trial.,"BACKGROUND
Behavioral and psychological symptoms of dementia (BPSD) affect 60-90% of patients with Alzheimer's disease (AD).
OBJECTIVE
To determine if environmental therapy is an effective strategy to reduce BPSD, we tested 163 patients with AD with Neuropsychiatric Inventory (NPI) before and after 6 months of an indoor therapeutic garden (TG) or standard environment.
METHODS
A single-blind randomized controlled trial on AD patients with BPSD. Participants were randomized to an indoor TG (N = 82), or standard environment (control, N = 81) for 6 months.
PRIMARY OUTCOME
change in the NPI score from baseline (T0) to end of treatment (T1).
SECONDARY OUTCOMES
change in use of quetiapine, cognition, activities of daily living, salivary cortisol, blood pressure from T0 to T1.
RESULTS
NPI score significantly ameliorated (TG versus control: -31.8 points), quetiapine dosage (-150 mg), blood pressure (-2.6 mm Hg), and salivary cortisol (-6.4 to -2.1 Nmol/l) were significantly reduced, the Mini-Mental State Examination significantly improved (1.8 points) in the TG versus control arm at T1 (p < 0.001). No adverse events were reported.
CONCLUSION
The indoor TG seems safe and may reduce BPSD, medication intake, and cortisol levels in AD.",2019,"NPI score significantly ameliorated (TG versus control: -31.8 points), quetiapine dosage (-150 mg), blood pressure (-2.6 mm Hg), and salivary cortisol (-6.4 to -2.1 Nmol/l) were significantly reduced, the Mini-Mental State Examination significantly improved (1.8 points) in the TG versus control arm at T1 (p < 0.001).","[""patients with Alzheimer's disease (AD"", ""Alzheimer's Disease"", '163 patients with AD with Neuropsychiatric Inventory (NPI) before and after 6 months of an indoor therapeutic garden (TG) or standard environment', 'AD patients with BPSD']","['quetiapine', 'indoor TG (N\u200a=\u200a82), or standard environment (control, N\u200a=\u200a81) for 6 months']","['salivary cortisol', 'adverse events', 'NPI score from baseline (T0) to end of treatment (T1', 'BPSD, medication intake, and cortisol levels', 'quetiapine, cognition, activities of daily living, salivary cortisol, blood pressure from T0 to T1', 'blood pressure', 'NPI score', 'Mini-Mental State Examination']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4019428', 'cui_str': 'Gardens'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1868717', 'cui_str': 'BPSD'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1868717', 'cui_str': 'BPSD'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}]",,0.281332,"NPI score significantly ameliorated (TG versus control: -31.8 points), quetiapine dosage (-150 mg), blood pressure (-2.6 mm Hg), and salivary cortisol (-6.4 to -2.1 Nmol/l) were significantly reduced, the Mini-Mental State Examination significantly improved (1.8 points) in the TG versus control arm at T1 (p < 0.001).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedrinolla', 'Affiliation': 'Department of Neuroscience, Biomedicine, and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tamburin', 'Affiliation': 'Department of Neuroscience, Biomedicine, and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Brasioli', 'Affiliation': 'Monsignor Mazzali Foundation, Mantua, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Sollima', 'Affiliation': 'Department of Clinical and Experimental Sciences, University Health and Wealth of Brescia, Brescia, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fonte', 'Affiliation': 'Department of Neuroscience, Biomedicine, and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'Muti', 'Affiliation': 'Monsignor Mazzali Foundation, Mantua, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Department of Neuroscience, Biomedicine, and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Schena', 'Affiliation': 'Department of Neuroscience, Biomedicine, and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Venturelli', 'Affiliation': 'Department of Neuroscience, Biomedicine, and Movement Sciences, University of Verona, Verona, Italy.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190394']
938,32438138,External pop-out versus classic technique for delivery of the fetal head during elective cesarean section: A randomized clinical trial.,"OBJECTIVE
This study aims to compare two techniques (External pop-out versus classic technique) for delivery of the fetal head during elective cesarean section (CS).The potential clinical predictors associated with unintended uterine incision extension during fetal head delivery among women delivered by elective CS were also assessed.
METHODS
A randomized clinical trial conducted at a tertiary University hospital between February 2017 and January 2019. Participants were randomly assigned to the classic head delivery technique (group I) or external Pop-out (EPO) technique (group II). The primary outcome was the incidence of unintended uterine incision extension during elective CS. A logistic regression model was utilized to examine the association between patient's characteristics and the occurrence of unintended uterine incision extension.
RESULTS
Participants in both groups (455 women in each group) had similar demographic characteristics. The EPO group had a significantly lower incidence of uterine incision extension than the classic group (p = 0.006). The operative time was significantly shorter in the EPO group (p = 0.000), which was also significantly easier than the classic technique (p = 0.001). The high body mass index (p = 0.004), previous delivery by CS (p = 0.010), high birth weight (p = 0.001) and the classic technique for head delivery (p = 0.002) were significant predictors for uterine incision tears.
CONCLUSIONS
EPO technique is an easy technique for fetal head delivery during elective CS with a lower risk of uterine incision extension and shorter operative time.",2020,The EPO group had a significantlylower incidence of uterine incision extension than the classic group(p = 0.006).,"['fetal head during elective cesarean section', 'Participants in both groups (455 women in each group) had similar demographic characteristics', 'tertiary University hospital betweenFebruary 2017 andJanuary 2019']","['External pop-out versus classic technique', 'EPO', 'techniques (External pop-out versus classic technique', 'classic head delivery technique (group I) or external Pop-out (EPO) technique']","['incidence of unintendeduterine incision extension during elective CS', 'high birth weight', 'operative time', 'high body mass index', 'uterine incision extension', 'classic technique for head delivery']","[{'cui': 'C0231117', 'cui_str': 'Fetal head structure'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0441843', 'cui_str': 'Group I'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0349482', 'cui_str': 'High birth weight'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",,0.0981983,The EPO group had a significantlylower incidence of uterine incision extension than the classic group(p = 0.006).,"[{'ForeName': 'Ali M El', 'Initials': 'AME', 'LastName': 'Saman', 'Affiliation': ""Department of Obstetrics & Gynecology, Woman's Health Hospital, Faculty of Medicine, Assiut University, Egypt.""}, {'ForeName': 'Mohamed Ashraf', 'Initials': 'MA', 'LastName': 'Mohamed', 'Affiliation': 'Department of Obstetrics & Gynecology, Luxor International Hospital, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abbas', 'Affiliation': ""Department of Obstetrics & Gynecology, Woman's Health Hospital, Faculty of Medicine, Assiut University, Egypt. Electronic address: ahmedabbas@aun.edu.eg.""}, {'ForeName': 'Alshymaa H', 'Initials': 'AH', 'LastName': 'Eleraky', 'Affiliation': ""Department of Obstetrics & Gynecology, Woman's Health Hospital, Faculty of Medicine, Assiut University, Egypt.""}, {'ForeName': 'Mohammed K', 'Initials': 'MK', 'LastName': 'Ali', 'Affiliation': ""Department of Obstetrics & Gynecology, Woman's Health Hospital, Faculty of Medicine, Assiut University, Egypt.""}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101806']
939,10768308,Topiramate in Lennox-Gastaut syndrome: open-label treatment of patients completing a randomized controlled trial. Topiramate YL Study Group.,"PURPOSE
The response to topiramate (TPM) as long-term adjunctive therapy was evaluated in patients with Lennox-Gastaut syndrome (LGS) in a long-term, open-label extension to a double-blind, placebo-controlled trial.
METHODS
In 97 patients with LGS (mean age, 11 years), dosages of TPM and concomitant antiepileptic drugs (AEDs) were adjusted to optimal clinical response (mean TPM dosage, 10 mg/kg/day).
RESULTS
For those patients who had completed 6 months of TPM therapy, drop attacks were reduced > or =50% in 55% of patients; 15% of patients had no drop attacks for > or =6 months at the last visit. After treatment up to 3+ years, 71% of patients who started open-label TPM were continuing therapy at the last visit.
CONCLUSIONS
During long-term therapy, TPM is effective and well tolerated in controlling the treatment-resistant drop attacks and seizures associated with LGS.",2000,"During long-term therapy, TPM is effective and well tolerated in controlling the treatment-resistant drop attacks and seizures associated with LGS.","['Lennox-Gastaut syndrome', '97 patients with LGS (mean age, 11 years), dosages of TPM and concomitant antiepileptic drugs (AEDs) were adjusted to optimal clinical response (mean TPM dosage, 10 mg/kg/day', 'patients with Lennox-Gastaut syndrome (LGS']","['Topiramate', 'placebo', 'TPM', 'topiramate (TPM']",[],"[{'cui': 'C0238111', 'cui_str': 'Lennox-Gastaut syndrome (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],97.0,0.0303707,"During long-term therapy, TPM is effective and well tolerated in controlling the treatment-resistant drop attacks and seizures associated with LGS.","[{'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Glauser', 'Affiliation': ""Children's Comprehensive Epilepsy Program, Children's Hospital Medical Center, Cincinnati, Ohio 45229, USA.""}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Levisohn', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ritter', 'Affiliation': ''}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Sachdeo', 'Affiliation': ''}]",Epilepsia,[]
940,32141724,Early- Versus Adult-Onset Schizophrenia as a Predictor of Response to Neuroscience-Informed Cognitive Training.,"BACKGROUND
Developmental stages characterized by greater neural plasticity might be critical periods during which the effects of cognitive training (CT) could theoretically be maximized. However, experiencing a first episode of schizophrenia during childhood or adolescence (ie, early-onset schizophrenia [EOS]) may reduce the brain's ability to benefit from CT. This study examined the effects of EOS versus onset at > 18 years of age (ie, adult-onset schizophrenia [AOS]) as a predictor of response to CT and the relationship between duration of illness and cognitive improvements.
METHODS
This study is a secondary analysis of data from 2 randomized trials that examined the cognitive effects of neuroscience-informed auditory training (AT) exercises in 84 outpatients with schizophrenia (26 EOS, 58 AOS, recruited between 2004 and 2014).
RESULTS
There was a significant effect of time in all cognitive domains (F > 10.22, P < .002). The effect of EOS was significant only for verbal learning and memory (F = 5.79, P = .018). AOS increased the mean change score by 5.70 points in this domain, whereas EOS showed no change (t = -2.280, P = .025). However, the difference between AOS and EOS was no longer statistically significant after control for multiple comparisons. Shorter duration of illness was associated with greater improvement in problem solving in the AOS group (r = -0.27, P = .040).
CONCLUSIONS
Auditory training is effective in improving cognition in both EOS and AOS. Treatment effects in all cognitive domains were similar, with the exception of verbal learning and memory. This result requires replication. Cognitive training provided earlier in the course of the illness results in greater improvements in executive functions.
TRIAL REGISTRATION
ClinicalTrials.gov identifiers: NCT00312962, NCT00694889.",2020,"There was a significant effect of time in all cognitive domains (F > 10.22, P < .002).","['84 outpatients with schizophrenia (26 EOS, 58 AOS, recruited between 2004 and 2014', 'versus onset at > 18 years of age (ie, adult-onset schizophrenia [AOS']","['Cognitive training', 'Auditory training', 'neuroscience-informed auditory training (AT) exercises', 'EOS', 'cognitive training (CT', 'Early']","['time in all cognitive domains', 'verbal learning and memory', 'Shorter duration of illness', 'problem solving', 'mean change score', 'AOS and EOS']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",84.0,0.0583286,"There was a significant effect of time in all cognitive domains (F > 10.22, P < .002).","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Puig', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, Hospital Clínic Barcelona, Villarroel 170, 08036-Spain. opuig@clinic.ub.es.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Loewy', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, California, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Miley', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Ramsay', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Cameron S', 'Initials': 'CS', 'LastName': 'Carter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, Davis, California, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Ragland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, Davis, California, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Niendam', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, Davis, California, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.18m12369']
941,32103514,"Dexamethasone on postoperative gastrointestinal motility: A placebo-controlled, double-blinded, randomized controlled trial.","BACKGROUND AND AIM
Following abdominal surgery, patients usually experience a transient episode of impaired gastrointestinal motility. This study aimed to determine whether a single preoperative dose of dexamethasone can promote the recovery of gastrointestinal function in patients following elective gastrointestinal surgery.
METHODS
In this single-center, two-arm, parallel, randomized controlled trial, we studied 126 patients (aged 18-80 years) who underwent elective open or laparoscopic bowel surgery for malignant or benign pathology. At the induction of anesthesia, a treatment group (n = 64) received a single dose of 8-mg intravenous dexamethasone, and a control group (n = 62) received normal saline.
RESULTS
Intravenous administration of 8-mg dexamethasone significantly decreased the time to return of flatus by an average of approximately 8 h (P < 0.05). Abdominal distension was significantly reduced on the third day after surgery in the dexamethasone group (P < 0.05), and the time to tolerance of a liquid diet was shorter in the dexamethasone group (P < 0.01). There were no significant differences in other secondary outcomes, including postoperative pain, complication rates, length of hospital stay, or time to first defecation, between the two groups.
CONCLUSIONS
A single intravenous dose of 8-mg dexamethasone at induction of anesthesia significantly decreases the time to return of flatus, improves abdominal distension at 72 h, and promotes tolerance of a liquid diet. Although further studies are required to confirm our results, we recommend that dexamethasone should be used more widely in gastrointestinal surgery.",2020,Abdominal distension was significantly reduced on the third day after surgery in the dexamethasone group (p<0.05) and the time to tolerance of a liquid diet was shorter in the dexamethasone group (p<0.01).,"['for malignant or benign pathology', '126 patients (aged 18-80 years) who underwent', 'patients following elective gastrointestinal surgery']","['Dexamethasone', 'placebo', 'dexamethasone', 'elective open or laparoscopic bowel surgery', 'normal saline']","['time to return of flatus', 'postoperative pain, complication rates, length of hospital stay, or time to first defecation', 'Abdominal distension', 'time to return of flatus, improves abdominal distension', 'time to tolerance of a liquid diet', 'postoperative gastrointestinal motility']","[{'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal Surgical Procedure'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0017184', 'cui_str': 'Gastrointestinal Motility'}]",126.0,0.420909,Abdominal distension was significantly reduced on the third day after surgery in the dexamethasone group (p<0.05) and the time to tolerance of a liquid diet was shorter in the dexamethasone group (p<0.01).,"[{'ForeName': 'Yuezhi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Chenyang', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Lian', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Yuehan', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Wenhai', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Changkun', 'Initials': 'C', 'LastName': 'Du', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Leping', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Tian', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Changqing', 'Initials': 'C', 'LastName': 'Jing', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15020']
942,32103645,Can Current Recommendations on Sun Exposure Sufficiently Increase Serum Vitamin D Level?: One-Month Randomized Clinical Trial.,"BACKGROUND
Lack of sunlight exposure is the primary reason for the worldwide epidemic of vitamin D deficiency. Although recommended sunlight exposure guidelines exist, there is no evidence regarding whether current guidelines are optimal for increasing vitamin D levels among individuals with vitamin D deficiency.
METHODS
Sixty Korean adults aged 20-49 years with serum 25-hydroxyvitamin D (25[OH]D) levels of < 20 ng/mL were randomly assigned to three groups: sunlight exposure (n = 20), vitamin D supplementation groups (n = 20), and daily living (n = 20) for 1 month. The sunlight exposure group had sunlight exposure on 20% to 30% of their body surface areas for 30-60 minutes per day, 3 times a week during the summer season. Vitamin D supplementation was prescribed with 800 IU/day of vitamin D. The serum levels of 25(OH)D were measured at baseline and at 1-month follow-up examinations.
RESULTS
The largest change in serum 25(OH)D was observed among the vitamin D supplementation group (+3.5 ng/mL, P < 0.001). The sunlight exposure group showed a slight increase in serum 25(OH)D level, but the absolute increase was less than one-third that of the vitamin D supplementation group (+0.9 ng/mL, P = 0.043). Only two participants in the sunlight exposure reached serum concentrations of 25(OH)D ≥ 20 ng/mL at follow-up. The daily living group showed no difference in vitamin D levels (-0.7 ng/mL, P = 0.516).
CONCLUSION
Sunlight exposure was not sufficient to overcome vitamin D insufficiency or deficiency in the current study subjects. Effectiveness of current sunlight exposure guidelines among various populations should be reassessed in larger clinical studies.
TRIAL REGISTRATION
Clinical Research Information Service Identifier: KCT0002671.",2020,"The daily living group showed no difference in vitamin D levels (-0.7 ng/mL, P = 0.516).
","['Sixty Korean adults aged 20-49 years with serum 25-hydroxyvitamin D (25[OH]D) levels of < 20 ng/mL', 'individuals with vitamin D deficiency']","['vitamin D supplementation', 'current sunlight exposure guidelines', 'sunlight exposure', 'Vitamin D supplementation', 'vitamin D']","['serum 25(OH)D level', 'serum concentrations of 25(OH)D ≥', 'serum 25(OH)D', 'serum levels of 25(OH)D', 'vitamin D levels']","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]",60.0,0.147966,"The daily living group showed no difference in vitamin D levels (-0.7 ng/mL, P = 0.516).
","[{'ForeName': 'Yu Mi', 'Initials': 'YM', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.'}, {'ForeName': 'Se A', 'Initials': 'SA', 'LastName': 'Kim', 'Affiliation': 'Department of Biomedical Science, Kyungpook National University Graduate School, Daegu, Korea.'}, {'ForeName': 'Duk Hee', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.'}]",Journal of Korean medical science,['10.3346/jkms.2020.35.e50']
943,32496604,Response of preterm infants with transient hypothyroxinaemia of prematurity to the thyrotropin-releasing hormone stimulation test is characterized by a delayed decrease in thyroid-stimulating hormone after the peak.,"OBJECTIVES
We evaluated the response to the thyrotropin-releasing hormone (TRH) stimulation test in very low-birth weight (VLBW) infants to elucidate the aetiology of transient hypothyroxinaemia of prematurity (THOP).
DESIGN AND METHODS
We performed TRH stimulation tests on 43 VLBW infants. Subjects were divided into two groups; a THOP group (N = 11; basal TSH < 15 mU/L and basal FT4 ≤ 0.8 ng/dL) and a non-THOP group (N = 32; basal TSH < 15 mU/L and basal FT4 > 0.8 ng/dL). Basal FT4 and FT3 were measured before, and TSH (0, 30, 60, 90, 120 and 180 minutes) was measured after, the administration of TRH (7 µg/kg). We calculated the ratio of TSH 180 minutes to THS 0 minute as the primary outcome. We also collected data on T3 and rT3 in this study.
RESULTS
In both groups, TSH 30 minutes values were the highest. However, the ratios of TSH 180 minutes to THS 0 minutes in the non-THOP group and the THOP group were (median [IQR]) 1.3 [1.0-1.7] and 3.0 [1.5-5.3] (P < .01). No significant differences were observed in T3 (1.0 [0.8-1.3] and 0.7 [0.4-0.7] ng/mL, P = .06). However, in the THOP group, rT3 was significantly lower than that of the non-THOP group (168.0 [148.1-197.0] and 92.9 [74.7-101.6] pg/mL, P < .01).
CONCLUSIONS
The delayed decrease in the TSH concentration after the peak for the TRH tests and decreased levels of rT3 suggest that the main aetiology for THOP is suppression at the level of the hypothalamus, but not inactivation of peripheral thyroid hormone metabolism.",2020,"No significant differences were observed in T3 (1.0 [0.8-1.3] and 0.7 [0.4-0.7] ng/mL, p=0.06).","['preterm infants with transient hypothyroxinemia of prematurity', 'very low birth weight (VLBW) infants', '43 VLBW infants']","['basal TSH < 15 mU/L and basal FT4 ≤ 0.8 ng/dL) and a Non-THOP group (N=32; basal TSH', 'THOP', 'thyrotropin-releasing hormone (TRH) stimulation test', 'basal FT4']","['Basal FT4 and FT3', 'rT3', 'TSH concentration']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C3827793', 'cui_str': 'Transient hypothyroxinaemia of prematurity'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0439342', 'cui_str': 'mU/L'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C3827793', 'cui_str': 'Transient hypothyroxinaemia of prematurity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040162', 'cui_str': 'Thyrotropin-Releasing Hormone'}, {'cui': 'C0201780', 'cui_str': 'Stimulation test'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",43.0,0.0682753,"No significant differences were observed in T3 (1.0 [0.8-1.3] and 0.7 [0.4-0.7] ng/mL, p=0.06).","[{'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kogoro', 'Initials': 'K', 'LastName': 'Iwanaga', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsukura', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Fusako', 'Initials': 'F', 'LastName': 'Niwa', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Takita', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Kawai', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]",Clinical endocrinology,['10.1111/cen.14260']
944,32506922,Exploratory Analysis of the Impact of an mHealth Medication Adherence Intervention on Tacrolimus Trough Concentration Variability: Post Hoc Results of a Randomized Controlled Trial.,"BACKGROUND
Medication nonadherence is a leading cause of late allograft loss in kidney transplantation (KT). Tacrolimus trough coefficient of variation (CV), measured using the coefficient of variation, is strongly correlated with acute rejection, graft function, and graft loss.
OBJECTIVE
The objective of this study was to determine if this mobile health (mHealth) intervention aimed at improving medication adherence in a nonadherent KT population would affect high intrapatient tacrolimus variability.
METHODS
A 6-month, prospective, parallel-arm, randomized controlled clinical trial was conducted to determine the effects of an mHealth intervention on tacrolimus CV. Intervention arm participants utilized an electronic medication tray and an mHealth app to monitor home-based adherence. Tailored motivational reinforcement messages were delivered to promote competence for adherence. Tacrolimus CV was measured using a 12-month rolling average, assessed at monthly intervals (6-month intervention period and 6 months after completion of the study); 80 were included, 40 in each arm.
RESULTS
At baseline, tacrolimus CV was similar between arms (37% ± 15% intervention, 37% ± 13% control, P = 0.894). Patients randomized to the intervention had a significant reduction in mean 12-month tacrolimus CVs ( P = 0.046) and a significant improvement in the proportion achieving low tacrolimus CV (tacrolimus CV < 40%; P = 0.001), as compared with the control arm.
CONCLUSION AND RELEVANCE
High tacrolimus CV is a risk factor for acute rejection and graft loss; these results offer the potential promise of improved medication adherence and clinical outcomes through the use of innovative technology.",2020,"Patients randomized to the intervention had a significant reduction in mean 12-month tacrolimus CVs ( P = 0.046) and a significant improvement in the proportion achieving low tacrolimus CV (tacrolimus CV < 40%; P = 0.001), as compared with the control arm. ",['kidney transplantation (KT'],"['mHealth intervention', 'mHealth Medication Adherence Intervention', 'tacrolimus CV', 'Tacrolimus CV', 'electronic medication tray and an mHealth app to monitor home-based adherence']","['proportion achieving low tacrolimus CV', 'Tacrolimus trough coefficient of variation (CV', 'tacrolimus CV', 'mean 12-month tacrolimus CVs', 'acute rejection, graft function, and graft loss']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008509', 'cui_str': 'Sampling of chorionic villus'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}]",,0.159573,"Patients randomized to the intervention had a significant reduction in mean 12-month tacrolimus CVs ( P = 0.046) and a significant improvement in the proportion achieving low tacrolimus CV (tacrolimus CV < 40%; P = 0.001), as compared with the control arm. ","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'McGillicuddy', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Chandler', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Luke R', 'Initials': 'LR', 'LastName': 'Sox', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Taber', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}]",The Annals of pharmacotherapy,['10.1177/1060028020931806']
945,31511629,The effect of surface electromyography biofeedback on the activity of extensor and dorsiflexor muscles in elderly adults: a randomized trial.,"Surface electromyography-biofeedback (sEMG-B) is a technique employed for the rehabilitation of patients with neurological pathologies, such as stroke-derived hemiplegia; however, little is known about its effectiveness in the rehabilitation of the extension and flexion of several muscular groups in elderly patients after a stroke. Therefore, this research was focused on determining the effectiveness of sEMG-B in the muscles responsible for the extension of the hand and the dorsiflexion of the foot in post-stroke elderly subjects. Forty subjects with stroke-derived hemiplegia were randomly divided into intervention or control groups. The intervention consisted of 12 sEMG-B sessions. The control group underwent 12 weeks (24 sessions) of conventional physiotherapy. Muscle activity test and functionality (Barthel index) were determined. Attending to the results obtained, the intervention group showed a higher increase in the average EMG activity of the extensor muscle of the hand and in the dorsal flexion of the foot than the control group (p < 0.001 in both cases), which was associated with an increase in the patients' Barthel index score (p = 0.006); In addition, Fugl-Meyer test revealed higher effectiveness in the lower limb (p = 0.007). Thus, the sEMG-B seems to be more effective than conventional physiotherapy, and the use of this technology may be essential for improving muscular disorders in elderly patients with physical disabilities resulting from a stroke.",2019,"Attending to the results obtained, the intervention group showed a higher increase in the average EMG activity of the extensor muscle of the hand and in the dorsal flexion of the foot than the control group (p < 0.001 in both cases), which was associated with an increase in the patients' Barthel index score (p = 0.006); In addition, Fugl-Meyer test revealed higher effectiveness in the lower limb (p = 0.007).","['elderly adults', 'patients with neurological pathologies', 'Forty subjects with stroke-derived hemiplegia', 'post-stroke elderly subjects', 'elderly patients after a stroke', 'elderly patients with physical disabilities resulting from a stroke']","['surface electromyography biofeedback', 'Surface electromyography-biofeedback (sEMG-B', 'conventional physiotherapy']","['average EMG activity of the extensor muscle of the hand and in the dorsal flexion of the foot', ""patients' Barthel index score"", 'activity of extensor and dorsiflexor muscles', 'Muscle activity test and functionality (Barthel index']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap (finding)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0430815', 'cui_str': 'Surface Electromyography'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",40.0,0.0233435,"Attending to the results obtained, the intervention group showed a higher increase in the average EMG activity of the extensor muscle of the hand and in the dorsal flexion of the foot than the control group (p < 0.001 in both cases), which was associated with an increase in the patients' Barthel index score (p = 0.006); In addition, Fugl-Meyer test revealed higher effectiveness in the lower limb (p = 0.007).","[{'ForeName': 'Ana Belén', 'Initials': 'AB', 'LastName': 'Gámez', 'Affiliation': 'Physiotherapy Service, ""Sagrado Corazón"" Hospital, Malaga, Spain.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Hernandez Morante', 'Affiliation': 'Faculty of Health and Life Sciences, Catholic University of Murcia, Murcia, Spain. jjhernandez@ucam.edu.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Martínez Gil', 'Affiliation': 'Physiotherapy Service, Arrixaca Hospital, Murcia, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Esparza', 'Affiliation': 'International Chair of Cineanthropometry, Catholic University of Murcia, Murcia, Spain.'}, {'ForeName': 'Carlos Manuel', 'Initials': 'CM', 'LastName': 'Martínez', 'Affiliation': 'IMIB - Experimental Pathology Service, Arrixaca Hospital, Murcia, Spain.'}]",Scientific reports,['10.1038/s41598-019-49720-x']
946,31411498,"Greater Suppression of Glucagon, Lipolysis, and Ketogenesis with Insulin Glargine U300 as Compared with Glargine U100 in Type 1 Diabetes Mellitus.","The aim of this study was to establish the effects of clinical doses of Gla-300 versus Gla-100 on suppression of glucagon, lipolysis, and ketogenesis in type 1 diabetes mellitus (T1DM). Eighteen persons with T1DM (age 40 ± 12 years, diabetes duration 26 ± 12 years, body mass index 23.4 ± 2 kg/m 2 , A1C 7.19% ± 0.52% [55 ± 6 mmol/mol]) were studied after 3 months of titration with Gla-300 and Gla-100 (randomized, crossover design) with a 24-h euglycemic clamp (s.c. injection of individual insulin daily doses used by subjects for previous 2 weeks, Gla-300 0.35 ± 0.08 and Gla-100 0.28 ± 0.07 U/kg). Gla-300 resulted in (1) less increase in insulin concentration for 0-12 h, but greater insulin concentration in 12-24 h (no differences for 24 h); (2) greater glucagon suppression; (3) greater prehepatic insulin-to-glucagon molar ratio, primarily in 12-24 h (ratio 1.78, 90% confidence intervals [CIs] 1.5-2.1); and (4) lower 24-h free fatty acid (0.81; 90% CI 0.73-0.89), glycerol (0.78; 90% CI 0.65-0.94), and β-hydroxybutyrate (0.72; 90% CI 0.58-0.90). Over the 24 h postinjection, as compared with Gla-100, clinical doses of Gla-300 exhibit greater suppressive effects on glucagon, lipolysis, and ketogenesis, whereas the effects on glucose metabolism are equivalent.",2020,"Gla-300 resulted in 1) less increase in insulin concentration over 0-12 h, but greater insulin concentration in 12-24 h (no differences over 24 h); 2) greater glucagon suppression; 3) greater prehepatic insulin-to-glucagon molar ratio, primarily in 12-24 h (ratio 1.78, 90%CIs 1.5;2.1); and 4) lower 24 h FFA (0.81; 90%CI 0.73;0.89), glycerol (0.78; 90%CI 0.65;0.94) and -hydroxybutyrate (0.72; 90%CI 0.58;0.90).","['Eighteen persons with T1DM [age 40±12 yrs, diabetes duration 26±12 yrs, BMI 23.4±2 kg/m2, A1C 7.19±0.52 % (55±6 mmol/mol']","['Gla-300 vs Gla-100', 'Gla-300 0.35±0.08 and Gla-100']","['insulin concentration', 'glucagon suppression; 3) greater prehepatic insulin-to-glucagon molar ratio', 'suppression of glucagon, lipolysis and ketogenesis in T1DM', 'glucagon, lipolysis and ketogenesis']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}]","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}]",18.0,0.0237564,"Gla-300 resulted in 1) less increase in insulin concentration over 0-12 h, but greater insulin concentration in 12-24 h (no differences over 24 h); 2) greater glucagon suppression; 3) greater prehepatic insulin-to-glucagon molar ratio, primarily in 12-24 h (ratio 1.78, 90%CIs 1.5;2.1); and 4) lower 24 h FFA (0.81; 90%CI 0.73;0.89), glycerol (0.78; 90%CI 0.65;0.94) and -hydroxybutyrate (0.72; 90%CI 0.58;0.90).","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Lucidi', 'Affiliation': 'Section of Endocrinology & Metabolism, Department of Medicine, Perugia University School of Medicine, Perugia, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Porcellati', 'Affiliation': 'Section of Endocrinology & Metabolism, Department of Medicine, Perugia University School of Medicine, Perugia, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Cioli', 'Affiliation': 'Section of Endocrinology & Metabolism, Department of Medicine, Perugia University School of Medicine, Perugia, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Candeloro', 'Affiliation': 'Section of Endocrinology & Metabolism, Department of Medicine, Perugia University School of Medicine, Perugia, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Marinelli Andreoli', 'Affiliation': 'Section of Endocrinology & Metabolism, Department of Medicine, Perugia University School of Medicine, Perugia, Italy.'}, {'ForeName': 'Geremia B', 'Initials': 'GB', 'LastName': 'Bolli', 'Affiliation': 'Section of Endocrinology & Metabolism, Department of Medicine, Perugia University School of Medicine, Perugia, Italy.'}, {'ForeName': 'Carmine G', 'Initials': 'CG', 'LastName': 'Fanelli', 'Affiliation': 'Section of Endocrinology & Metabolism, Department of Medicine, Perugia University School of Medicine, Perugia, Italy.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0231']
947,32506228,Alteration of Streptococcus salivarius in Buccal Mucosa of Oral Lichen Planus and Controlled Clinical Trial in OLP Treatment.,"Oral lichen planus (OLP) is a T cell-mediated common chronic inflammatory mucosal disease, with limited therapies available for long-term use. Previous study showed that ratio of genus Streptococcus decreased significantly in OLP patients when compared with controls. Buccal cotton swab samples of 43 OLP patients and 48 healthy individuals were collected for real-time quantitative polymerase chain reaction (RT-PCR) to investigate relative abundance alteration of Streptococcus salivarius in OLP lesions. Bacterial supernatants of S. salivarius ATCC® BAA-2593™ were collected by centrifugation and added to HSC-3 cells, and quantitative analysis of expression of IL-1β, IL-6, IL-8, and TNF-α in the HSC-3 cells was determined by RT-PCR. Then, a randomized, non-blinded, controlled study was conducted. Forty patients with symptomatic OLP were randomly allocated into two groups and received topical treatment of 0.1% triamcinolone acetonide dental paste (group A) and S. salivarius K12 lozenge (group B), respectively, for 4 weeks. Sign scores, visual analogue scale (VAS), and adverse reactions were recorded. Relative abundance of S. salivarius in the OLP group was lower than that of control group (P < 0.05). After treated with 0.1% supernatants of S. salivarius ATCC® BAA-2593™, the expression level of IL-6 in the HSC-3 cells significantly reduced (P < 0.001), while IL-1β, IL-8, and TNF- α showed a decreasing tendency (P > 0.05). There was significant reduction in sign scores and VAS scores in both groups after the 4-week treatment, with no significant difference between two groups. No adverse reaction was observed. S. salivarius might maintain local immune balance by inhibiting the NF-κB pathway. Topical application of Streptococcus salivarius K12 seemed to be effective in treatment of symptomatic OLP, especially with promising potential in long-term use. More detailed clinical studies with long follow-up period and standardized usage/dosage are expected to acquire definite conclusions.",2020,Relative abundance of S. salivarius in the OLP group was lower than that of control group (P < 0.05).,"['Forty patients with symptomatic OLP', '43 OLP patients and 48 healthy individuals']","['Oral lichen planus (OLP', 'Streptococcus salivarius', 'topical treatment of 0.1% triamcinolone acetonide dental paste (group A) and S. salivarius K12 lozenge']","['expression level of IL-6 in the HSC-3 cells', 'adverse reaction', 'ratio of genus Streptococcus', 'sign scores and VAS scores', 'Sign scores, visual analogue scale (VAS), and adverse reactions', 'Relative abundance of S. salivarius']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0318179', 'cui_str': 'Streptococcus salivarius'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C4706462', 'cui_str': 'Dental paste'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",40.0,0.0766109,Relative abundance of S. salivarius in the OLP group was lower than that of control group (P < 0.05).,"[{'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Oral Medicine, Shanghai Engineering Research Center of Tooth Restoration and Regeneration, School & Hospital of Stomatology, Tongji University, Middle Yanchang Road 399, Shanghai, People's Republic of China, 200072.""}, {'ForeName': 'Fangyang', 'Initials': 'F', 'LastName': 'Shao', 'Affiliation': ""Department of Oral Medicine, Shanghai Engineering Research Center of Tooth Restoration and Regeneration, School & Hospital of Stomatology, Tongji University, Middle Yanchang Road 399, Shanghai, People's Republic of China, 200072.""}, {'ForeName': 'Saiwei', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': ""Department of Oral Medicine, Shanghai Engineering Research Center of Tooth Restoration and Regeneration, School & Hospital of Stomatology, Tongji University, Middle Yanchang Road 399, Shanghai, People's Republic of China, 200072.""}, {'ForeName': 'Zhengwu', 'Initials': 'Z', 'LastName': 'Tan', 'Affiliation': ""Department of Oral Medicine, Shanghai Engineering Research Center of Tooth Restoration and Regeneration, School & Hospital of Stomatology, Tongji University, Middle Yanchang Road 399, Shanghai, People's Republic of China, 200072.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Oral Medicine, Shanghai Engineering Research Center of Tooth Restoration and Regeneration, School & Hospital of Stomatology, Tongji University, Middle Yanchang Road 399, Shanghai, People's Republic of China, 200072. drheyuan@tongji.edu.cn.""}]",Probiotics and antimicrobial proteins,['10.1007/s12602-020-09664-5']
948,32507424,Mindfulness training for healthcare professional students: A waitlist controlled pilot study on psychological and work-relevant outcomes.,"OBJECTIVES
To fill gaps in the literature on the effects of mindfulness for healthcare professionals (HCPs), the current pragmatic trial investigated feasibility, acceptability, and effectiveness of Mindfulness for Interdisciplinary Healthcare Professional (MIHP) students on stress and work-relevant outcomes in the absence of offering school-based incentives.
DESIGN
A partially randomized waitlist-controlled design (intention-to-treat sample: 22 in the mindfulness group, 26 in the control group) was employed.
INTERVENTION
MIHP is an eight-week intervention that incorporates meditation training, yoga, and discussion on the application of mindfulness principles to stressors commonly faced by HCPs and students.
MAIN OUTCOME MEASURES
Domains of feasibility and acceptability; Maslach Burnout Inventory and other validated measures of psychological functioning; cognitive task performance on the Trail Making Test A & B; and the Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire.
RESULTS
Results supported the feasibility and acceptability of MIHP but found randomization to be unacceptable. Small to large effects were found for MIHP, relative to the control group, on outcomes of burnout, perceived stress, mindfulness, and activity impairment. No effect of MIHP was found on cognitive performance or work productivity outcomes.
CONCLUSIONS
Preferential group allocation improved retention relative to randomization in the absence of school-based incentives. Results suggest that MIHP is feasible and acceptable and may have benefit for improving mindfulness and reducing burnout, stress, and activity impairment. Cognitive performance, work absenteeism, and work impairment did not change following MIHP. Results support future investigations into the effects of participant compensation on MIHP's dissemination and effectiveness.",2020,"Small to large effects were found for MIHP, relative to the control group, on outcomes of burnout, perceived stress, mindfulness, and activity impairment.",['healthcare professional students'],"['MIHP', 'Mindfulness training']","['Cognitive performance, work absenteeism, and work impairment', 'cognitive performance or work productivity outcomes', 'Domains of feasibility and acceptability; Maslach Burnout Inventory and other validated measures of psychological functioning; cognitive task performance on the Trail Making Test A & B; and the Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire', 'feasibility and acceptability of MIHP', 'outcomes of burnout, perceived stress, mindfulness, and activity impairment']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.0305863,"Small to large effects were found for MIHP, relative to the control group, on outcomes of burnout, perceived stress, mindfulness, and activity impairment.","[{'ForeName': 'Sarah Ellen', 'Initials': 'SE', 'LastName': 'Braun', 'Affiliation': 'Virginia Commonwealth University, Department of Psychology, United States; Charleston Consortium Psychology Internship Program, United States. Electronic address: braunse2@vcu.edu.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Dow', 'Affiliation': 'Virginia Commonwealth University, Department of Internal Medicine, United States.'}, {'ForeName': 'Ashlee', 'Initials': 'A', 'LastName': 'Loughan', 'Affiliation': 'Virginia Commonwealth University, Department of Neurology, United States.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Mladen', 'Affiliation': 'Virginia Commonwealth University, Department of Psychology, United States.'}, {'ForeName': 'MaryKate', 'Initials': 'M', 'LastName': 'Crawford', 'Affiliation': 'Virginia Commonwealth University, Department of Psychology, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Rybarczyk', 'Affiliation': 'Virginia Commonwealth University, Department of Psychology, United States.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Kinser', 'Affiliation': 'Virginia Commonwealth University, School of Nursing, United States.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102405']
949,32507430,Effects of ear and body acupressure on labor pain and duration of labor active phase: A randomized controlled trial.,"OBJECTIVES
This study sought to compare the effects of multi-point ear and body acupressure on labor pain and the duration of labor active phase.
DESIGN
Three-armed randomized controlled trial.
SETTING
Kowsar Hospital, Qazvin, Iran.
INTERVENTION
Participants in the body acupressure group received acupressure on GB21, GB30, BL32, LI4, and SP6 points, each for two minutes, at cervical dilation of four, six, and eight centimeters. For participants in the ear acupressure group, adhesive auriculotherapy-specific Vaccaria seeds were attached to their auricles on the zero, genitalia, Shen Men, thalamic, and uterine 1 and 2 acupoints. The seeds were compressed every thirty minutes, each time for thirty seconds. Participants in the control group received routine care services.
MAIN OUTCOME MEASURES
Labor pain intensity was assessed using a visual analogue scale at cervical dilation of four and ten centimeters.
RESULTS
While there was no significant difference between mean scores of pain among three groups, mean score of labor pain in both acupressure groups was significantly less than that in the control group (P < 0.001). However, the difference between the acupressure groups was not statistically significant (P = 0.12). Moreover, the duration of labor active phase in the ear acupressure group was significantly less than those in the body acupressure and the control groups (P < 0.001).
CONCLUSION
Ear acupressure was significantly effective in reducing labor pain and shortening labor active phase. However, body acupressure solely reduces labor pain. Therefore, ear acupressure can be used to reduce labor pain and shorten labor active phase.",2020,"While there was no significant difference between mean scores of pain among three groups, mean score of labor pain in both acupressure groups was significantly less than that in the control group (P < 0.001).","['Kowsar Hospital, Qazvin, Iran']","['routine care services', 'Ear acupressure', 'ear and body acupressure', 'multi-point ear and body acupressure', 'Participants in the body acupressure group received acupressure']","['duration of labor active phase', 'labor pain and shortening labor active phase', 'labor pain and duration of labor active phase', 'mean score of labor pain', 'mean scores of pain', 'labor pain', 'labor pain and the duration of labor active phase', 'Labor pain intensity', 'visual analogue scale at cervical dilation of four and ten centimeters']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0475210', 'cui_str': 'cm'}]",,0.0415952,"While there was no significant difference between mean scores of pain among three groups, mean score of labor pain in both acupressure groups was significantly less than that in the control group (P < 0.001).","[{'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Alimoradi', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: Zainabalimoradi@yahoo.com.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Kazemi', 'Affiliation': 'Mother and Child Care Research Center, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: Faridehkazemi21@yahoo.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Gorji', 'Affiliation': 'Velayat Clinical & Educational Center, Qazvin University of Medical Science, Qazvin, Iran. Electronic address: maryam.gorji580@gmail.com.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Valiani', 'Affiliation': 'Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: valiani@nm.mui.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102413']
950,32507432,"The beneficial effects of therapeutic craniofacial massage on quality of life, mental health and menopausal symptoms and body image: A randomized controlled clinical trial.","OBJECTIVE
The objective of this study was to determine the effect of massage in the craniofacial area in menopausal women after the treatment and one month after its completion, and to measure its influence on quality of life in relation to symptoms of menopause, mental health, and body image perception.
DESIGN
50 participants with menopause, aged 45-65 years, participated in a single-blind randomized controlled trial. Participants were randomly assigned to two groups: craniofacial massage group (CMG), who received massage treatment (n = 25), and control group (CG), without treatment (n = 25). Prior to randomization, all participants provided demographic and clinical information. Quality of life, mental health and body image perception were evaluated at three time points: at the beginning of the study, at the end, and one month after finishing the treatment.
RESULTS
A repeated-measures multivariate analysis of variance (RM-MANOVA) was used to determine if mean scores in the criteria differed significantly between time points within subjects. The results obtained indicate that the cranial massage techniques had a large, positive between-subjects effect on our three criteria (Wilks Λ = .83, F( 3, 44 ) = 3.04, p. <.05; Partial η = .17; ƒ = .45) as well as a large, positive between-within subjects effect (Wilks Λ = .64, F( 6, 41 ) = 3.91, p. <.01; Partial η = .36; ƒ = .76). In short, our treatment improved participants' mental health, partially ameliorated the decrease in scores on the Menopause Rating Scale and stopped the decrease in Body Image perception's scores.
CONCLUSIONS
The craniofacial massage protocol, applied to the craniofacial sphere, constitutes a complementary and valid therapy-based therapeutic option for clinicians in the treatment of different symptoms that occur in the climacteric period.",2020,"In short, our treatment improved participants' mental health, partially ameliorated the decrease in scores on the Menopause Rating Scale and stopped the decrease in Body Image perception's scores.
","['menopausal women', '50 participants with menopause, aged 45-65 years']","['therapeutic craniofacial massage', 'craniofacial massage group (CMG), who received massage treatment']","[""participants' mental health"", 'quality of life, mental health and menopausal symptoms and body image', ""Body Image perception's scores"", 'Menopause Rating Scale', 'Quality of life, mental health and body image perception', 'quality of life in relation to symptoms of menopause, mental health, and body image perception']","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",50.0,0.0713743,"In short, our treatment improved participants' mental health, partially ameliorated the decrease in scores on the Menopause Rating Scale and stopped the decrease in Body Image perception's scores.
","[{'ForeName': 'Gemma V', 'Initials': 'GV', 'LastName': 'Espí-López', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, 46010 Valencia, Spain. Electronic address: gemma.espi@uv.es.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Monzani', 'Affiliation': 'Ivey Business School at Western University, Canada. Electronic address: lmonzani@ivey.ca.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gabaldón-García', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, 46010 Valencia, Spain. Electronic address: elenagabaldongarcia@gmail.com.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Zurriaga', 'Affiliation': 'University Research Institute of Human Resources Psychology, Organizational Development and Quality of Work Life (IDOCAL), University of Valencia, Spain. Electronic address: Rosario.Zurriaga@uv.es.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102415']
951,32507434,The effects of acupressure on the symptoms severity and function status and electrodiagnostic findings in patients with carpal tunnel syndrome.,"OBJECTIVE
This study aimed to evaluate the effects of acupressure on the symptoms severity, function status and electrodiagnostic findings in patients with Carpal tunnel syndrome (CTS).
DESIGN
This double blind, randomized, controlled clinical trial study was conducted on 57 patients with CTS that selected through convenience sampling. The patients were randomly assigned to three groups, including (1) acupressure; (2) placebo acupressure; and (3) control.
SETTING
The study was conducted in the medical centers affiliated to Semnan University of Medical Sciences, Iran.
INTERVENTION
The intervention groups received acupressure or placebo for one month. The control group received only routine cares (splints and analgesics) with no additional intervention.
PRIMARY OUTCOMES
The severity of symptoms and hand function were evaluated by the Boston Carpal Tunnel Syndrome Questionnaire, and electrodiagnostic findings, including Nerve Conduction Velocity (NCV), Distal Sensory Latency (DSL), and Distal Motor Latency (DML) were measured by Electromyography device before and after the intervention.
RESULTS
The results showed significant differences in the mean severity of symptoms, hand function, NCV, DSL, and DML before and after the intervention in the acupressure group (P < 0.05). Significant differences were also observed between the means difference in severity of symptoms, hand function, and NCV, DSL, and DML before and after the intervention in the three groups (P < 0.05).
CONCLUSION
According to the results, acupressure was effective in reducing the severity of clinical symptoms, improving the hand function, and improving the electrodiagnostic findings. Therefore, the application of acupressure can be recommended for improving clinical symptoms of patients with CTS.",2020,"The results showed significant differences in the mean severity of symptoms, hand function, NCV, DSL, and DML before and after the intervention in the acupressure group (P < 0.05).","['medical centers affiliated to Semnan University of Medical Sciences, Iran', '57 patients with CTS that selected through convenience sampling', 'patients with CTS', 'patients with Carpal tunnel syndrome (CTS', 'patients with carpal tunnel syndrome']","['routine cares (splints and analgesics) with no additional intervention', 'acupressure or placebo', 'acupressure; (2) placebo acupressure; and (3) control', 'acupressure']","['severity of clinical symptoms, improving the hand function, and improving the electrodiagnostic findings', 'mean severity of symptoms, hand function, NCV, DSL, and DML', 'Boston Carpal Tunnel Syndrome Questionnaire, and electrodiagnostic findings, including Nerve Conduction Velocity (NCV), Distal Sensory Latency (DSL), and Distal Motor Latency (DML', 'severity of symptoms, hand function, and NCV, DSL, and DML', 'severity of symptoms and hand function']","[{'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0429381', 'cui_str': 'Nerve conduction velocity'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",57.0,0.0170938,"The results showed significant differences in the mean severity of symptoms, hand function, NCV, DSL, and DML before and after the intervention in the acupressure group (P < 0.05).","[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Asgari', 'Affiliation': 'Nursing Care Research Center, Semnan University of Medical Sciences, Semnan, Iran; Department of Nursing, Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Saeideh Sadat', 'Initials': 'SS', 'LastName': 'Mosaviinejad', 'Affiliation': 'Student Research Committee, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Abbasali', 'Initials': 'A', 'LastName': 'Ebrahimian', 'Affiliation': 'Nursing Care Research Center, Semnan University of Medical Sciences, Semnan, Iran; Department of Nursing, Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Aminianfar', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran; Department of Physiotherapy, School of Rehabilitation Sciences, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Raheb', 'Initials': 'R', 'LastName': 'Ghorbani', 'Affiliation': 'Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran; Department of Epidemiology and Biostatistics, Faculty of Medicine, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Babamohamadi', 'Affiliation': 'Nursing Care Research Center, Semnan University of Medical Sciences, Semnan, Iran; Department of Nursing, Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: babamohamadi@semums.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102420']
952,32505171,The effect of 1% glucose loading on metabolism in the elderly patients during remifentanil-induced anesthesia: a randomized controlled trial.,"BACKGROUND
Previous studies showed that remifentanil-induced anesthesia can inhibit surgical stress response in non-diabetic adult patients and that low-dose glucose loading during anesthesia may attenuate fat catabolism. However, little is known about the influence of glucose loading on metabolism in elderly patients, whose condition may be influenced by decreased basal metabolism and increased insulin resistance. We hypothesized that, in elderly patients, intraoperative low glucose infusion may attenuate the catabolism of fat without causing harmful hyperglycemia during remifentanil-induced anesthesia.
METHODS
Elderly, non-diabetic patients scheduled to undergo elective surgery were enrolled and randomized to receive no glucose (0G group) or low-dose glucose infusion (0.1 g/kg/hr. for 1 h followed by 0.05 g/kg/hr. for 1 h; LG group) during surgery. Glucose, adrenocorticotropic hormone (ACTH), 3-methylhistidine (3-MH), insulin, cortisol, free fatty acid (FFA), creatinine (Cr), and ketone body levels were measured pre-anesthesia, 1 h post-glucose infusion, at the end of surgery, and on the following morning.
RESULTS
A total of 31 patients (aged 75-85) were included (0G, n = 16; LG, n = 15). ACTH levels during anesthesia decreased significantly in both groups. In the LG group, glucose levels increased significantly after glucose loading but hyperglycemia was not observed. During surgery, ketone bodies and FFA were significantly lower in the LG group than the 0G group. There were no significant differences in insulin, Cr, 3-MH, and 3-MH/Cr between the two groups.
CONCLUSION
Remifentanil-induced anesthesia inhibited surgical stress response in elderly patients. Intraoperative low-dose glucose infusion attenuated catabolism of fat without inducing hyperglycemia.
TRIAL REGISTRATION
This study has been registered with the University hospital Medical Information Network Center (http://www.umin.ac.jp/english/).
TRIAL REGISTRATION NUMBER
UMIN000016189. The initial registration date: January 12th 2015.",2020,"There were no significant differences in insulin, Cr, 3-MH, and 3-MH/Cr between the two groups.
","['31 patients (aged 75-85', 'elderly patients during remifentanil-induced anesthesia', 'Elderly, non-diabetic patients scheduled to undergo elective surgery', 'elderly patients', 'non-diabetic adult patients']","['Remifentanil-induced anesthesia', 'remifentanil-induced anesthesia', 'no glucose (0G group) or low-dose glucose infusion', 'glucose loading']","['Glucose, adrenocorticotropic hormone (ACTH), 3-methylhistidine (3-MH), insulin, cortisol, free fatty acid (FFA), creatinine (Cr), and ketone body levels', 'insulin, Cr, 3-MH, and 3-MH/Cr', 'glucose levels', 'ACTH levels during anesthesia', 'surgical stress response', 'hyperglycemia', 'ketone bodies and FFA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0047600', 'cui_str': '3-methyl histidine'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",31.0,0.0680124,"There were no significant differences in insulin, Cr, 3-MH, and 3-MH/Cr between the two groups.
","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Fukuta', 'Affiliation': 'Department of Anesthesiology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8503, Japan. kouhei_f_1983@yahoo.co.jp.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Kasai', 'Affiliation': 'Department of Anesthesiology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8503, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Niki', 'Affiliation': 'Department of Anesthesiology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8503, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Anesthesiology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8503, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Kawanishi', 'Affiliation': 'Department of Anesthesiology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8503, Japan.'}, {'ForeName': 'Nami', 'Initials': 'N', 'LastName': 'Kakuta', 'Affiliation': 'Department of Anesthesiology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8503, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Sakai', 'Affiliation': 'Department of Anesthesiology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8503, Japan.'}, {'ForeName': 'Yasuo M', 'Initials': 'YM', 'LastName': 'Tsutsumi', 'Affiliation': 'Department of Anesthesiology and Critical Care, Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi Minami, Hiroshima, 774-8551, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Anesthesiology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8503, Japan.'}]",BMC anesthesiology,['10.1186/s12871-020-01061-3']
953,32505177,Effects of dexmedetomidine on stress hormones in patients undergoing cardiac valve replacement: a randomized controlled trial.,"BACKGROUND
Stress response always occurs in cardiac valve replacement patients undergoing cardiopulmonary bypass (CPB).
METHODS
60 patients undergoing cardiac valve replacement were recruited and randomized into control and Dex groups. Dex group received 1.0 μg·kg-1 of Dex for 10 min intravenously before anesthesia, followed by 0.5 μg·kg-1·h-1 of Dex, steadily administered throughout the procedure. And controlled group received the identical velocity of saline as Dex group. Plasma level of cortisol (Cor), epinephrine (E), norepinephrine (NE), and serotonin (5-HT) were evaluated at four timepoints: Before administration (T0), sawn sternum (T1), end of extracorporeal circulation (T2), and 24 h post operation (T3). General data of operation and recovery such as heart rate (HR), mean arterial pressure (MAP), intraoperative bispectral index (BIS), and hospitalization time in the intensive care unit (ICU) were also compared.
RESULTS
Increase of Cor, E, NE, and 5-HT for the Dex group was significant lesser than that in the control group (P < 0.05), and ICU hospitalization time and ventilator support time was significantly shorter in the Dex group. The proportion of patients discharged from the hospital with better prognosis was significantly higher than that in the control group, while there were no significant differences in hospitalization costs and vasoactive drugs use between the two groups.
CONCLUSIONS
Dex reduces plasma Cor, E and NE elevations in patients after CPB, alleviates the stress reaction of the body, shortens the hospitalization time and ventilator support time in ICU, and plays a positive role in the rehabilitation of patients undergoing cardiac valve replacement.
TRIAL REGISTRATION
China Clinical Trial Registry (No. ChiCTR-IPR-17010954) March 22rd, 2017.",2020,"Dex reduces plasma Cor, E and NE elevations in patients after CPB, alleviates the stress reaction of the body, shortens the hospitalization time and ventilator support time in ICU, and plays a positive role in the rehabilitation of patients undergoing cardiac valve replacement.
","['cardiac valve replacement patients undergoing cardiopulmonary bypass (CPB', 'patients undergoing cardiac valve replacement', '60 patients undergoing cardiac valve replacement']","['1.0\u2009μg·kg-1 of Dex', 'dexmedetomidine', 'Dex']","['heart rate (HR), mean arterial pressure (MAP), intraoperative bispectral index (BIS), and hospitalization time in the intensive care unit (ICU', 'Cor, E, NE, and 5-HT', 'proportion of patients discharged from the hospital with better prognosis', 'ICU hospitalization time and ventilator support time', 'Plasma level of cortisol (Cor), epinephrine (E), norepinephrine (NE), and serotonin (5-HT', 'hospitalization costs and vasoactive drugs use', 'plasma Cor, E and NE elevations', 'stress hormones']","[{'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]",60.0,0.070869,"Dex reduces plasma Cor, E and NE elevations in patients after CPB, alleviates the stress reaction of the body, shortens the hospitalization time and ventilator support time in ICU, and plays a positive role in the rehabilitation of patients undergoing cardiac valve replacement.
","[{'ForeName': 'Hanhua', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, No. 149 Dalian Road, Huichuan District, Zunyi, 563003, Guizhou Province, China.'}, {'ForeName': 'Jinqing', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, Third Affiliated Hospital of Zunyi Medical University, Zunyi, 563003, Guizhou Province, China.'}, {'ForeName': 'Jiamei', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, No. 149 Dalian Road, Huichuan District, Zunyi, 563003, Guizhou Province, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, No. 149 Dalian Road, Huichuan District, Zunyi, 563003, Guizhou Province, China.'}, {'ForeName': 'Huijun', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, No. 149 Dalian Road, Huichuan District, Zunyi, 563003, Guizhou Province, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, No. 149 Dalian Road, Huichuan District, Zunyi, 563003, Guizhou Province, China. zhzmcc@sina.com.'}]",BMC anesthesiology,['10.1186/s12871-020-00993-0']
954,32513111,Effect of caudal ketamine on minimum local anesthetic concentration of ropivacaine in children: a prospective randomized trial.,"BACKGROUND
Caudal ketamine has been shown to provide an effective and prolonged post-operative analgesia with few adverse effects. However, the effect of caudal ketamine on the minimum local anesthetic concentration (MLAC) of ropivacaine for intra-operative analgesia is unclear.
METHODS
One hundred and sixty-nine children were randomized to five groups: Group C (caudal ropivacaine only), Group K 0.25 (caudal ropivacaine plus 0.25 mg/kg ketamine), Group K 0.5 (caudal ropivacaine plus 0.5 mg/kg ketamine), Group K 0.75 (caudal ropivacaine plus 0.75 mg/kg ketamine), and Group K 1.0 (caudal ropivacaine plus 1.0 mg/kg ketamine). The primary outcome was the MLAC values of ropivacaine with/without ketamine for caudal block.
RESULTS
The MLAC values of ropivacaine were 0.128% (0.028%) in the control group, 0.112% (0.021%) in Group K 0.25 , 0.112% (0.018%) in Group K 0.5 , 0.110% (0.019%) in Group K 0.75 , and 0.110% (0.020%) in Group K 1.0 . There were no significant differences among the five groups for the MLAC values (p = 0.11). During the post-operative period the mean durations of analgesia were 270, 381, 430, 494, and 591 min in the control, K 0.25 , K 0. 5 , K 0.75 , and K 1.0 groups respectively, which shown that control group is significantly different from all ketamine groups. Also there were significant differences between K 0.25 and K 0.75 groups, and between K 1.0 groups and the other ketamine groups.
CONCLUSIONS
Adding caudal ketamine to ropivacaine prolong the duration of post-operative analgesia; however, it does not decrease the MLAC of caudal ropivacaine for intra-operative analgesia in children.
CLINICAL TRIAL REGISTRATION
ChiCTR-TRC-13003492. Registered on 13 August 2013.",2020,There were no significant differences among the five groups for the MLAC values (p = 0.11).,"['One hundred and sixty-nine children', 'children']","['Group C (caudal ropivacaine only), Group K 0.25 (caudal ropivacaine plus 0.25\u2009mg/kg ketamine), Group K 0.5 (caudal ropivacaine plus 0.5\u2009mg/kg ketamine), Group K 0.75 (caudal ropivacaine plus 0.75\u2009mg/kg ketamine), and Group K 1.0 (caudal ropivacaine plus 1.0\u2009mg/kg ketamine', 'ropivacaine', 'caudal ketamine']","['MLAC values of ropivacaine with/without ketamine for caudal block', 'mean durations of analgesia', 'MLAC values of ropivacaine', 'duration of post-operative analgesia', 'minimum local anesthetic concentration', 'MLAC values']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0441845', 'cui_str': 'Group K'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4068882', 'cui_str': '0.75'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",169.0,0.0585345,There were no significant differences among the five groups for the MLAC values (p = 0.11).,"[{'ForeName': 'Huai-Zhen', 'Initials': 'HZ', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, 9# Jinsui Road, Guangzhou, 510623, China.""}, {'ForeName': 'Ling-Yu', 'Initials': 'LY', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, 9# Jinsui Road, Guangzhou, 510623, China.""}, {'ForeName': 'Hui-Hong', 'Initials': 'HH', 'LastName': 'Liang', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, 9# Jinsui Road, Guangzhou, 510623, China.""}, {'ForeName': 'Yan-Ting', 'Initials': 'YT', 'LastName': 'Fan', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, 9# Jinsui Road, Guangzhou, 510623, China.""}, {'ForeName': 'Xing-Rong', 'Initials': 'XR', 'LastName': 'Song', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, 9# Jinsui Road, Guangzhou, 510623, China.""}, {'ForeName': 'Ying-Jun', 'Initials': 'YJ', 'LastName': 'She', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, 9# Jinsui Road, Guangzhou, 510623, China. yjsheh@yeah.net.""}]",BMC anesthesiology,['10.1186/s12871-020-01058-y']
955,31982885,Cardiac Inotropes Offer Protection of Renal Function in Patients with Kidney Transplantation.,"INTRODUCTION
Impaired cardiac function is one of the most concomitant symptoms in patients with kidney failure after long-term dialysis. In addition, the preservation of adequate perfusion pressure to the graft plays a significant role in the intraoperative management during kidney transplantation, but the use of positive inotropic drugs in kidney transplant patients has been studied less. We investigated the protective effects of renal function by means of cardiac inotropes in kidney transplant patients.
METHODS
Eighty-nine patients that received kidney transplantation between April 2014 and December 2016 at Qilu Hospital were included and randomly divided into the treatment group receiving levosimendan and a control group. All kidney recipients received ABO-compatible donors. A poor outcome was defined as one of the following: delayed graft function, graft hemorrhage, or nephrectomy.
RESULTS
The treatment group had a better composite outcome and the level of neutrophil gelatinase-associated lipocalin was also lower than in the control group.
CONCLUSION
Inotropic drugs may play a protective role in renal function in kidney transplantation.",2020,"The treatment group had a better composite outcome and the level of neutrophil gelatinase-associated lipocalin was also lower than in the control group.
","['kidney transplant patients', 'kidney transplantation', 'Patients with Kidney Transplantation', 'Eighty-nine patients that received kidney transplantation between April 2014 and December 2016 at Qilu Hospital', 'patients with kidney failure after long-term dialysis']","['levosimendan and a control group', 'Cardiac Inotropes']","['delayed graft function, graft hemorrhage, or nephrectomy', 'level of neutrophil gelatinase-associated lipocalin']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1566590', 'cui_str': 'Delayed Graft Function'}, {'cui': 'C1407122', 'cui_str': 'Graft haemorrhage'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}]",,0.0316889,"The treatment group had a better composite outcome and the level of neutrophil gelatinase-associated lipocalin was also lower than in the control group.
","[{'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Guo', 'Affiliation': 'Department of Surgery and Transplantation, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Zehua', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Urology Surgery, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Laurine M', 'Initials': 'LM', 'LastName': 'Bow', 'Affiliation': 'Transplant Immunology Laboratory, Hartford Hospital, Hartford, Connecticut, USA.'}, {'ForeName': 'Xianquan', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Department of Surgery and Transplantation, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Luwei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Surgery and Transplantation, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Wanhua', 'Initials': 'W', 'LastName': 'Xian', 'Affiliation': 'Department of Surgery and Transplantation, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Huaibin', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Surgery and Transplantation, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Surgery and Transplantation, Qilu Hospital, Shandong University, Jinan, China, juntian63@sina.com.'}]",Kidney & blood pressure research,['10.1159/000504543']
956,32034876,A Hands-On Organ-Slicing Activity to Teach the Cross-Sectional Anatomy.,"The presentation of pre-sliced specimens is a frequently used method in the laboratory teaching of cross-sectional anatomy. In the present study, a new teaching method based on a hands-on slicing activity was introduced into the teaching of brain, heart, and liver cross-sectional anatomy. A randomized, controlled trial was performed. A total of 182 third-year medical students were randomized into a control group taught with the prosection mode (pre-sliced organ viewing) and an experimental group taught with the dissection mode (hands-on organ slicing). These teaching methods were assessed by testing the students' knowledge of cross-sectional specimens and cross-sectional radiological images, and analyzing students' feedback. Using a specimen test on three organs (brain, heart, and liver), significant differences were observed in the mean scores of the control and experimental groups: for brain 59.6% (±14.2) vs. 70.1% (±15.5), (P < 0.001, Cohen's d = 0.17); for heart: 57.6% (±12.5) vs. 75.6% (±15.3), (P < 0.001, d = 0.30); and for liver: 60.4% (±14.5) vs. 81.7% (±14.2), (P < 0.001, d = 0.46). In a cross-sectional radiological image test, better performance was also found in the experimental group (P < 0.001). The mean scores of the control vs. experimental groups were as follows: for brain imaging 63.9% (±15.1) vs. 71.1% (±16.1); for heart imaging 64.7% (±14.5) vs. 75.2% (±15.5); and for liver imaging 61.1% (±15.5) vs. 81.2% (±14.6), respectively. The effect sizes (Cohen's d) were 0.05, 0.23, and 0.52, respectively. Students in the lower tertile benefited the most from the slicing experiences. Students' feedback was generally positive. Hands-on slicing activity can increase the effectiveness of anatomy teaching and increase students' ability to interpret radiological images.",2020,"In a cross-sectional radiological image test, better performance was also found in the experimental group (P < 0.001).",['A total of 182 third-year medical students'],['control group taught with the prosection mode (pre-sliced organ viewing) and an experimental group taught with the dissection mode (hands-on organ slicing'],['mean scores'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0196539,"In a cross-sectional radiological image test, better performance was also found in the experimental group (P < 0.001).","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Anatomy, Nanjing Medical University, Nanjing, People's Republic of China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Anatomy, Nanjing Medical University, Nanjing, People's Republic of China.""}, {'ForeName': 'Yizhi', 'Initials': 'Y', 'LastName': 'Zuo', 'Affiliation': ""Department of Anatomy, Nanjing Medical University, Nanjing, People's Republic of China.""}]",Anatomical sciences education,['10.1002/ase.1947']
957,32493434,Community-based program to increase use of hearing conservation practices among farm and rural youth: a cluster randomized trial of effectiveness.,"BACKGROUND
Noise exposure and associated hearing loss affects an estimated 2 million farm youth who are exposed as farm residents, farm family workers, hired workers, children of migrant or seasonal workers, and farm visitors. Risk factors for farm youth include frequent exposure to high farm noise; farm work from an early age, and exposure to high recreational noise (e.g., firearms, ATVs, and personal listening devices).
METHODS
This study compared the effectiveness of two interventions and control. The programs included a community-based interactive youth educational program alone (Group A), a community-based interactive youth educational program followed by an Internet-based booster (Group B), and a no-interaction control (Group C). The study used a cluster randomized control design, with equal allocation ratio to each cluster, without blinding. Inclusion criteria included enrollment in grade 4, parental consent, English speaking, and attending a community-based educational event included in the cluster sampling. A total of 1979 youth were enrolled at 36 sites distributed across the 3 study arms in the following distribution: N = 662 in 13 sites (Group A), N = 680 in 12 sites (Group B), and N = 637 in 11 sites (Group C).
RESULTS
Comparison with pre-intervention data showed no difference in intent to use hearing conservation strategies in experimental groups. However, knowledge and attitudes toward hearing conservation were improved in the groups receiving the Internet-based booster. Participants reported frequent exposure to sources of hazardous noise (e.g., loud sporting events, firecrackers, personal listening devices).
CONCLUSIONS
It is feasible and acceptable to incorporate hearing health education into an already existing system designed to deliver health and safety educational programming to farm and rural youth. The program was adopted by the partner agency for dissemination to up to 100,000 youth annually. Results of this study inform future intervention studies, interventions aimed at farm youth, and interventions to increase use of hearing conservation strategies, as well as offer a base for developing programs for non-English speaking children.
TRIAL REGISTRATION
Clinicaltrials.gov registration CT02472821. Date of trial registration: 06/09/2015 (retrospectively registered).",2020,It is feasible and acceptable to incorporate hearing health education into an already existing system designed to deliver health and safety educational programming to farm and rural youth.,"['hearing conservation practices among farm and rural youth', 'A total of 1979 youth were enrolled at 36 sites distributed across the 3 study arms in the following distribution: N\xa0=\u2009662 in 13 sites (Group A), N\xa0=\u2009680 in 12 sites (Group B), and N\xa0', '2 million farm youth who are exposed as farm residents, farm family workers, hired workers, children of migrant or seasonal workers, and farm visitors', 'Inclusion criteria included enrollment in grade 4, parental consent, English speaking, and attending a community-based educational event included in the cluster sampling']","['Community-based program', 'community-based interactive youth educational program alone (Group A), a community-based interactive youth educational program followed by an Internet-based booster (Group B), and a no-interaction control']","['knowledge and attitudes toward hearing conservation', 'frequent exposure to sources of hazardous noise (e.g., loud sporting events, firecrackers, personal listening devices']","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0557759', 'cui_str': 'Farming environment'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026093', 'cui_str': 'Migrant'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0600634', 'cui_str': 'Parental Consent'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0336696', 'cui_str': 'Firecracker'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",,0.0391096,It is feasible and acceptable to incorporate hearing health education into an already existing system designed to deliver health and safety educational programming to farm and rural youth.,"[{'ForeName': 'Marjorie C', 'Initials': 'MC', 'LastName': 'McCullagh', 'Affiliation': 'School of Nursing, University of Michigan, 400 North Ingalls Street, Ann Arbor, MI, 48109-5482, USA. mcculla@umich.edu.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, University of Michigan, 400 North Ingalls Street, Ann Arbor, MI, 48109-5482, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Cohen', 'Affiliation': 'School of Nursing, University of Michigan, 400 North Ingalls Street, Ann Arbor, MI, 48109-5482, USA.'}]",BMC public health,['10.1186/s12889-020-08972-3']
958,32500212,Subjective features of the psilocybin experience that may account for its self-administration by humans: a double-blind comparison of psilocybin and dextromethorphan.,"RATIONALE
Although both psilocybin and dextromethorphan (DXM) produce psychedelic-like subjective effects, rates of non-medical use of psilocybin are consistently greater than DXM.
OBJECTIVE
New data are presented from a study of psilocybin and DXM relevant to understanding the features of psilocybin subjective effects that may account for its higher rates of non-medical use.
METHODS
Single, acute oral doses of psilocybin (10, 20, 30 mg/70 kg), DXM (400 mg/70 kg), and placebo were administered under double-blind conditions to 20 healthy participants with histories of hallucinogen use.
RESULTS
High doses of both drugs produced similar time courses and increases in participant ratings of peak overall drug effect strength. Nine subjective effect domains are proposed to be related to the reinforcing effects of psilocybin: liking, visual effects, positive mood, insight, positive social effects, increased awareness of beauty (both visual and music), awe/amazement, meaningfulness, and mystical experience. For most ratings, (1) psilocybin and DXM both produced effects significantly greater than placebo; (2) psilocybin showed dose-related increases; 3, DXM was never significantly higher than psilocybin; (4) the two highest psilocybin doses were significantly greater than DXM. These differences were consistent with two measures of desire to take the drug condition again.
CONCLUSIONS
This analysis provides new information about domains of psilocybin subjective effects proposed to be related to its reinforcing effects (alternatively described as the ""motivation"" to use). Observed differences on these domains between psilocybin and DXM are consistent with the relative rates of non-medical use of psilocybin and DXM.",2020,"For most ratings, (1) psilocybin and DXM both produced effects significantly greater than placebo; (2) psilocybin showed dose-related increases; 3, DXM was never significantly higher than psilocybin; (4) the two highest psilocybin doses were significantly greater than DXM.",['20 healthy participants with histories of hallucinogen use'],"['psilocybin and dextromethorphan', 'psilocybin and dextromethorphan (DXM', 'psilocybin', 'DXM', 'placebo']","['visual effects, positive mood, insight, positive social effects, increased awareness of beauty (both visual and music), awe/amazement, meaningfulness, and mystical experience', 'participant ratings of peak overall drug effect strength', 'DXM']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0018533', 'cui_str': 'Hallucinogen'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0004898', 'cui_str': 'Beauty'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}]",20.0,0.150916,"For most ratings, (1) psilocybin and DXM both produced effects significantly greater than placebo; (2) psilocybin showed dose-related increases; 3, DXM was never significantly higher than psilocybin; (4) the two highest psilocybin doses were significantly greater than DXM.","[{'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Carbonaro', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD, 21224-6823, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Johnson', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD, 21224-6823, USA.'}, {'ForeName': 'Roland R', 'Initials': 'RR', 'LastName': 'Griffiths', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD, 21224-6823, USA. rgriff@jhmi.edu.'}]",Psychopharmacology,['10.1007/s00213-020-05533-9']
959,32497605,The duration of intrapartum supplemental oxygen administration and umbilical cord oxygen content.,"BACKGROUND
Maternal oxygen (O 2 ) administration is a commonly performed intrauterine resuscitation technique though to improve fetal oxygenation. However, hyperoxygenation is known to be harmful in both neonates and adults. Currently, there are no formal recommendations on whether a certain dose or duration of O 2 may be most helpful in improving umbilical cord gases or neonatal outcomes.
OBJECTIVE
We tested the hypothesis that prolonged supplemental O 2 exposure during labor is associated with increased umbilical cord O 2 concentrations.
STUDY DESIGN
This was a planned secondary analysis of a randomized noninferiority trial comparing O 2 with room air in laboring patients. Patients were randomized to receive either 10 L/min O 2 or room air at any point during active labor when they developed a category II fetal heart tracing that would otherwise require resuscitation. The primary outcome variable for this analysis was partial pressure of O 2 in the umbilical vein. The secondary outcome variable was partial pressure of O 2 in the umbilical artery. These outcome variables were compared between patients with short durations of O 2 exposure and those with long durations of O 2 exposure, defined as <75th percentile and ≥75th percentile of duration, respectively. The outcomes were also compared among the groups that received room air, O 2 for short durations, and O 2 for long durations.
RESULTS
Among the 99 patients with paired and validated cord gases who were included in this analysis, the partial pressure of O 2 in the umbilical vein was significantly lower in patients who received O 2 supplementation for longer durations than in those who received O 2 for shorter durations (median interquartile range 25.5 [21.5-33] vs 32.5 [26.5-37.5] mm Hg; P<.03). There was no difference in the partial pressure of O 2 in the umbilical artery or other cord gases between the short and long duration O 2 supplementation groups. Other methods of intrauterine resuscitation were similar between the short and long duration O 2 supplementation groups. There was no difference in the partial pressure of O 2 in the umbilical artery or in the umbilical vein when the room air, short duration O 2 supplementation, and long duration O 2 supplementation groups were compared.
CONCLUSION
Longer durations of O 2 exposure are not associated with a higher partial pressure of O 2 in the umbilical cord. In fact, patients with longer durations of O 2 exposure had lower partial pressure of O 2 in the umbilical vein, suggesting impaired placental O 2 transfer with prolonged O 2 exposure.",2020,"There was no difference in UA or UV pO 2 when compared between RA, short duration O 2 , and long duration O 2 groups.
",['laboring patients'],[],"['umbilical vein (UV) pO 2 ', 'duration of intrapartum supplemental oxygen administration and umbilical cord oxygen content', 'UA pO 2 or other cord gases', 'umbilical artery (UA) pO 2 ']","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0041637', 'cui_str': 'Structure of umbilical vein'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0523806', 'cui_str': 'Oxygen measurement'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0041632', 'cui_str': 'Structure of umbilical artery'}]",99.0,0.283401,"There was no difference in UA or UV pO 2 when compared between RA, short duration O 2 , and long duration O 2 groups.
","[{'ForeName': 'Virginia Y', 'Initials': 'VY', 'LastName': 'Watkins', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO. Electronic address: Watkinsv@wustl.edu.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Martin', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Department of Obstetrics and Gynecology, Dell Medical School, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Methodius G', 'Initials': 'MG', 'LastName': 'Tuuli', 'Affiliation': 'Department of Obstetrics and Gynecology, Indiana University, Bloomington, IN.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Obstetrics and Gynecology, Dell Medical School, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Raghuraman', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.056']
960,32502876,Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study.,"BACKGROUND
Brentuximab vedotin was approved for adult patients with CD30-expressing cutaneous T-cell lymphoma treated with prior systemic therapy based on improved response rates and progression-free survival with brentuximab vedotin (1.8 mg/kg once every 3 weeks; ≤16 cycles) versus physician's choice (methotrexate/bexarotene; ≤48 weeks) in the phase III ALCANZA study. Quality of life (QoL) in ALCANZA patients was also examined.
METHODS
QoL measures in ALCANZA were based on the Skindex-29, Functional Assessment of Cancer Therapy-General (FACT-G) and European QoL 5-dimension (EQ-5D) questionnaires.
RESULTS
Mean maximum reduction from the baseline Skindex-29 symptom domain score (key secondary end-point) was greater with brentuximab vedotin than physician's choice (-27.96 versus -8.62); the difference, -18.9 (95% confidence interval -26.6, -11.2; adjusted p < 0.001), exceeded the study-defined minimally important difference (9.0-12.3). Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus -2.29). EQ-5D changes were also comparable between arms. Among brentuximab vedotin-treated patients with peripheral neuropathy (PN), mean maximum reduction in Skindex-29 symptom domain was -35.54 versus -11.11 in patients without PN. PN had no meaningful effect on FACT-G and EQ-5D QoL scores.
CONCLUSIONS
In summary, brentuximab vedotin produced superior reductions in symptom burden compared with physician's choice, without adversely impacting QoL. QoL was unaffected by the presence of PN in brentuximab vedotin-treated patients.
CLINICAL TRIAL REGISTRATION
NCT01578499.",2020,Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus -2.29).,"['patients with relapsed/refractory cutaneous T-cell lymphoma', 'adult patients with CD30-expressing\xa0cutaneous T-cell lymphoma treated with prior']","[""physician's choice (methotrexate/bexarotene"", 'Cancer Therapy-General', 'European QoL 5-dimension', 'systemic therapy']","['quality of life', 'Skindex-29 symptom domain', 'FACT-G and EQ-5D QoL scores', 'Quality of life (QoL', 'EQ-5D changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0079773', 'cui_str': 'Cutaneous T-cell lymphoma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0054950', 'cui_str': 'Lymphocyte antigen CD30'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0765273', 'cui_str': 'bexarotene'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.118026,Mean changes from baseline to end-of-treatment visit total FACT-G scores were similar with brentuximab vedotin and physician's choice (0.15 versus -2.29).,"[{'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Universitäts Spital Zürich, Rämistrasse 100, Zürich 8091, Switzerland. Electronic address: reinhard.dummer@usz.ch.'}, {'ForeName': 'Henry M', 'Initials': 'HM', 'LastName': 'Prince', 'Affiliation': ""Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Melbourne, Victoria 8066, Australia. Electronic address: miles.prince@petermac.org.""}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Whittaker', 'Affiliation': 'Division of Genetics and Molecular Medicine, Faculty of Life Sciences and Medicine, Kings College London & Guys and St Thomas NHS Foundation Trust, London, UK. Electronic address: sean.whittaker@gstt.nhs.uk.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Horwitz', 'Affiliation': 'Memorial Hospital, 1275 York Avenue, Between 67th and 68th Streets, New York, NY 10065, USA. Electronic address: horwitzs@MSKCC.ORG.'}, {'ForeName': 'Youn H', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Stanford Clinical Cancer Center, 875 Blake Wilbur Drive, Stanford, CA 94305, USA. Electronic address: younkim@stanford.edu.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Scarisbrick', 'Affiliation': 'Nuffield House, Dermatology - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Birmingham B15 2TH, UK. Electronic address: Julia.Scarisbrick@uhb.nhs.uk.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Quaglino', 'Affiliation': 'University of Turin, Turin, Italy. Electronic address: Pietro.quaglino@unito.it.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'Institute of Hematology ""Seràgnoli"", University of Bologna, Via Massarenti 9, Bologna 40138, Italy. Electronic address: pierluigi.zinzani@unibo.it.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Wolter', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium. Electronic address: pascalwolter@hotmail.com.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Eradat', 'Affiliation': 'Hematology Oncology, UCLA Lymphoma Program, Bone Marrow Transplant Program, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: Heradat@mednet.ucla.edu.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Pinter-Brown', 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California, Irvine, CA, USA. Electronic address: lpinterb@uci.edu.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Sanches', 'Affiliation': 'Division of Clinical Dermatology, Hospital Das Clinicas, FMUSP, Department of Dermatology, University of Sao Paulo Medical School, Brazil. Electronic address: jasanchesjr@gmail.com.'}, {'ForeName': 'Pablo L', 'Initials': 'PL', 'LastName': 'Ortiz-Romero', 'Affiliation': 'University Hospital 12 de Octubre, Institute i+12, Medical School, Universidad Complutense, Madrid, Spain. Electronic address: portiz.hdoc@salud.madrid.org.'}, {'ForeName': 'Oleg E', 'Initials': 'OE', 'LastName': 'Akilov', 'Affiliation': 'University of Pittsburgh School of Medicine, Biomedical Science Tower, Room E1157, 200 Lothrop Street, Pittsburgh, PA 15261-2109, USA. Electronic address: akilovoe@upmc.edu.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Geskin', 'Affiliation': 'Department of Dermatology, Columbia University and CUMC, 161 Fort Washington Ave, 12th Floor, New York, NY 10032, USA. Electronic address: ljg2145@cumc.columbia.edu.'}, {'ForeName': 'Auris', 'Initials': 'A', 'LastName': 'Huen', 'Affiliation': 'University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Box 1452, Houston, TX, USA. Electronic address: aohuen@mdanderson.org.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Walewski', 'Affiliation': 'Maria Sklodowska-Curie National Research Institute of Oncology, 5 WK Roentgen Str, Warszawa 02-781, Poland. Electronic address: jan.walewski@coi.pl.'}, {'ForeName': 'Yinghui', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: ywang@seagen.com.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lisano', 'Affiliation': 'Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: jlisano@seagen.com.'}, {'ForeName': 'Akshara', 'Initials': 'A', 'LastName': 'Richhariya', 'Affiliation': 'Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: arichhariya@seagen.com.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Feliciano', 'Affiliation': 'Seattle Genetics, Inc., Bothell, WA, USA. Electronic address: felicianojoseph1@gmail.com.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: Yanyan.Zhu@takeda.com.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Bunn', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: Veronica.Bunn@takeda.com.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Little', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: meredith.little@takeda.com.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Zagadailov', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: erin.zagadailov@gmail.com.'}, {'ForeName': 'Mehul R', 'Initials': 'MR', 'LastName': 'Dalal', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA. Electronic address: mehul.dalal@takeda.com.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Duvic', 'Affiliation': 'University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Box 1452, Houston, TX, USA. Electronic address: mduvic@mdanderson.org.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.010']
961,32504715,Rehabilitation Posture Does Not Affect the Outcome of Arthroscopically Treated Acromioclavicular Dislocation.,"PURPOSE
To assess the effect of the patient's posture (erect or supine) during rehabilitation sessions on pain, function, and the coracoclavicular (CC) distance after arthroscopic treatment of acromioclavicular joint dislocation.
METHODS
Sixty patients with acute type III or V acromioclavicular dislocation injuries were randomly allocated into 2 groups according to their posture during the rehabilitation phase: supine rehabilitation group (SRG) or erect rehabilitation group (ERG). Arthroscopic stabilization with a suspensory fixation device was used in all patients. The visual analog scale (VAS) score was assessed on the first postoperative day and at 1, 3, and 6 months postoperatively. The Constant-Murley score (CMS) was recorded preoperatively and at 3, 6, 12, and 24 months postoperatively. The CC distance was assessed preoperatively; on the first postoperative day; and at 6, 12, and 24 months postoperatively.
RESULTS
No significant differences were found between the 2 groups in terms of the VAS score, CMS, and CC distance changes. A significant improvement over the follow-up phase was identified in the VAS score and CMS in both groups. The CC distance in both groups was significantly reduced from preoperatively (29.34 mm in the ERG and 28.65 mm in the SRG) to the first postoperative day (10.44 mm and 10.11 mm, respectively). However, a statistically significant re-widening of the CC distance (P < .001) occurred within the first 6 months after surgery (13.55 mm in the ERG and 13.50 mm in the SRG) and at 12 months (15.51 mm and 15.80 mm, respectively).
CONCLUSIONS
The patient's posture during early postoperative rehabilitation does not affect the CC distance changes.
LEVEL OF EVIDENCE
Level I, randomized prospective comparative study.",2020,"No significant differences were found between the two groups in terms of the VAS, CMS scores, and CC distance changes.","['Sixty patients with acute AC dislocation injury types, III and V']","['Arthroscopic stabilization with a suspensory fixation device', ""patient's posture (erect or supine"", 'posture during the rehabilitation phase (Supine Rehabilitation Group; SRG, or Erect Rehabilitation Group; ERG']","['coracoclavicular (CC) distance', 'Constant-Murley Score (CMS', 'CC distance', 'Visual Analogue Scale (VAS', 'coracoclavicular distance changes', 'VAS, CMS scores, and CC distance changes', 'pain, function and the CC (Coracoclavicular) distance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0449499', 'cui_str': 'Type of injury'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0441254', 'cui_str': 'Fixation device'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",60.0,0.018762,"No significant differences were found between the two groups in terms of the VAS, CMS scores, and CC distance changes.","[{'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Gameel', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Abdelghafar', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Tarek Mohamed', 'Initials': 'TM', 'LastName': 'Ghandour', 'Affiliation': 'Orthopedic Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt. Electronic address: tarekghndr@yahoo.com.'}, {'ForeName': 'Begad M', 'Initials': 'BM', 'LastName': 'Samy Abbas', 'Affiliation': 'Physical Medicine, Rheumatology and Rehabilitation Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.05.043']
962,32511726,Intra-Individual Variability in Sleep Schedule: Effects of an Internet-Based Cognitive-Behavioral Therapy for Insomnia Program and its Relation with Symptom Remission.,"STUDY OBJECTIVES
Sleep schedule consistency is fundamental to cognitive behavioral therapy for insomnia (CBT-I), although there is limited evidence suggesting whether it predicts treatment response. This analysis tested whether: (1) an Internet-based CBT-I program affects intra-individual variability (IIV) in sleep schedule, and (2) sleep schedule IIV predicts insomnia symptom remission.
METHODS
This secondary analysis compares participants (N=303) randomized to an Internet-based CBT-I program (SHUTi - Sleep Healthy Using the Internet) or Internet-based patient education (PE). Participants reported daily bedtimes and rising times on ten online sleep diaries collected over two weeks at baseline and nine-week post-intervention assessment. Participants completed the Insomnia Severity Index (ISI) at post-assessment and six-month follow-up; symptom remission was defined by ISI<8. Mixed effects location scale modeling was used to examine the effect of SHUTi on bedtime and rising time IIV; a novel two-staged analysis examined the effect of bedtime and rising time IIV on insomnia symptom remission.
RESULTS
At post-assessment, SHUTi participants reported about 30% less bedtime and 32% less rising time variability compared to PE (ps<.03). Bedtime and rising time IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps>.18), nor did sleep schedule IIV moderate treatment response (ps>.12).
CONCLUSIONS
Findings demonstrate that an Internet-delivered CBT-I program can effectively increase users' sleep schedule consistency relative to an educational control. This consistency, however, was not related to treatment outcome when defined by insomnia symptom remission, suggesting that enforcing rigid sleep schedules for patients may not be necessary for treatment success.",2020,"IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps>.18), nor did sleep schedule IIV moderate treatment response (ps>.12).
",[],"['Internet-based CBT-I program (SHUTi - Sleep Healthy Using the Internet) or Internet-based patient education (PE', 'Internet-Based Cognitive-Behavioral Therapy', 'SHUTi']","['daily bedtimes and rising times on ten online sleep diaries', 'insomnia symptom remission', 'rising time variability', 'Insomnia Severity Index (ISI', 'symptom remission', 'Bedtime and rising time']",[],"[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]",303.0,0.0636908,"IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps>.18), nor did sleep schedule IIV moderate treatment response (ps>.12).
","[{'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Shaffer', 'Affiliation': 'University of Virginia, Center for Behavioral Health and Technology, Charlottesville, VA, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'University of Chicago, Department of Public Health Sciences, Chicago, IL, USA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Morin', 'Affiliation': 'Laval University, Department of Psychology, Québec, QC, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Ingersoll', 'Affiliation': 'University of Virginia, Center for Behavioral Health and Technology, Charlottesville, VA, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Thorndike', 'Affiliation': 'Pear Therapeutics, Inc, [department n/a], Boston, MA, USA.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Ritterband', 'Affiliation': 'University of Virginia, Center for Behavioral Health and Technology, Charlottesville, VA, USA.'}]",Sleep,['10.1093/sleep/zsaa115']
963,32511774,Dietary sodium intake and cortisol measurements.,"OBJECTIVES
To assess the influence of a dietary sodium intake intervention on cortisol measurements within the general population.
DESIGN
Cross-over intervention.
PATIENTS
Six hundred thirty adults without known Cushing syndrome, cardiovascular or renal disease completed a restricted dietary sodium diet (10 mmol/d, 230 mg/d) followed by cross-over to a liberalized dietary sodium diet (200 mmol/d, 4600 mg/d). Twenty-four-hour urine collection and biochemical investigations were performed at the end of each dietary intervention.
RESULTS
Mean 24-hour urinary free cortisol increased with liberalized sodium intake when compared with restricted sodium intake (178.0 ± 89.7 vs 121.3 ± 65.6 nmol/d, P < .001). Nearly all participants (84%) had an increase in the urinary free cortisol following liberalized sodium intake. This translated to a substantial difference in the proportion of participants exceeding categorical thresholds of urinary cortisol on liberalized vs restricted sodium intake: 62% vs 27% for 138 nmol/d (50 mcg/d), 46% vs 17% for 166 nmol/d (60 mcg/d), 32% vs 10% for 193 nmol/d (70 mcg/d), 23% vs 6% for 221 nmol/d (80 mcg/d), 17% vs 4% for 248 nmol/d (90 mcg/d). In parallel, there was a small decrease in morning total serum cortisol with liberalized sodium intake (303.0 ± 117.3 vs 326.4 ± 162.5 nmol/L, P < .001).
CONCLUSIONS
Increased dietary sodium intake increases urinary free cortisol excretion and may increase the risk for false-positive results. Variations in dietary sodium intake may influence the interpretations of cortisol measurements performed to evaluate for hypercortisolism.",2020,"Mean 24-hour urinary free cortisol increased with liberalized sodium intake when compared with restricted sodium intake (178.0 ± 89.7 vs. 121.3 ± 65.6 nmol/day, p<0.001).","['630 adults without known Cushing syndrome, cardiovascular or renal disease completed a']","['restricted dietary sodium diet (10 mmol/day, 230 mg/day) followed by cross-over to a liberalized dietary sodium diet', 'dietary sodium intake intervention']","['Mean 24-hour urinary free cortisol', 'Dietary Sodium Intake and Cortisol Measurements', 'morning total serum cortisol', 'urinary free cortisol', 'cortisol measurements']","[{'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0010481', 'cui_str': ""Cushing's syndrome""}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0037570', 'cui_str': 'Dietary Sodium'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439433', 'cui_str': 'mmol/24h'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}]",630.0,0.0210742,"Mean 24-hour urinary free cortisol increased with liberalized sodium intake when compared with restricted sodium intake (178.0 ± 89.7 vs. 121.3 ± 65.6 nmol/day, p<0.001).","[{'ForeName': 'Angela X', 'Initials': 'AX', 'LastName': 'Chen', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Andrea V', 'Initials': 'AV', 'LastName': 'Haas', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Williams', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Vaidya', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}]",Clinical endocrinology,['10.1111/cen.14262']
964,32517582,Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source: NAVIGATE-ESUS Trial.,"BACKGROUND AND PURPOSE
Risks, sites, and predictors of major bleeding during antithrombotic therapies have not been well defined for patients with recent embolic stroke of undetermined source.
METHODS
Exploratory analysis of major bleeds defined by International Society of Thrombosis and Hemostasis criteria occurring among 7213 participants in international NAVIGATE (New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial) embolic stroke of undetermined source randomized trial comparing rivaroxaban 15 mg daily with aspirin 100 mg daily.
RESULTS
During a median follow-up of 11 months, 85 major bleeds occurred. The most frequent site was gastrointestinal (38%), followed by intracranial (29%). Assignment to rivaroxaban (hazard ratio [HR], 2.7 [95% CI, 1.7-4.3]), East Asia region (HR, 2.5 [95% CI, 1.6-3.9]), systolic blood pressure ≥160 mm Hg (HR, 2.2 [95% CI, 1.2-3.8]), and reduced estimated glomerular filtration rate (HR, 1.2 per 10 mL/min per 1.73 m 2 decrease, [95% CI, 1.0-1.3]) were independently associated with presence of major bleeds. Five (6%) were fatal. Among 15 patients with intracerebral hemorrhage, 2 (13%) were fatal. There was no evidence of an early high-risk period following initiation of rivaroxaban. The annualized rate of intracerebral hemorrhage was 6-fold higher among East Asian participants (0.67%) versus all other regions (0.11%; HR, 6.3 [95% CI, 2.2-18.0]). Distribution of bleeding sites was similar for rivaroxaban and aspirin.
CONCLUSIONS
Among embolic stroke of undetermined source patients participating in an international randomized trial, independent predictors of major bleeding were assignment to rivaroxaban, East Asia region, increased systolic blood pressure, and impaired renal function. East Asia as a region was strongly associated with risk of intracerebral hemorrhage. Estimated glomerular filtration rate should be a consideration for stratifying bleeding risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02313909.",2020,"The annualized rate of intracerebral hemorrhage was 6-fold higher among East Asian participants (0.67%) versus all other regions (0.11%; HR, 6.3 [95% CI, 2.2-18.0]).","['Patients With Embolic Strokes of Undetermined Source', 'patients with recent embolic stroke of undetermined source', 'Exploratory analysis of major bleeds defined by International Society of Thrombosis and Hemostasis criteria occurring among 7213 participants in international NAVIGATE (New Approach Rivaroxaban Inhibition of Factor Xa in a Global trial) embolic stroke', '15 patients with intracerebral hemorrhage, 2 (13%) were fatal']","['rivaroxaban', 'rivaroxaban 15 mg daily with aspirin 100 mg daily']","['annualized rate of intracerebral hemorrhage', 'systolic blood pressure, and impaired renal function', 'systolic blood pressure', 'glomerular filtration rate', 'Distribution of bleeding sites']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0015520', 'cui_str': 'Coagulation factor Xa'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0262469', 'cui_str': 'Embolic stroke'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3247999', 'cui_str': 'rivaroxaban 15 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1124475', 'cui_str': 'Aspirin 100 MG'}]","[{'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",15.0,0.431584,"The annualized rate of intracerebral hemorrhage was 6-fold higher among East Asian participants (0.67%) versus all other regions (0.11%; HR, 6.3 [95% CI, 2.2-18.0]).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mikulík', 'Affiliation': ""International Clinical Research Center and Neurology Department, St. Anne's University Hospital and Masaryk University Brno, Czech Republic (R.M.).""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Eckstein', 'Affiliation': 'Department of Internal Medicine, University Hospital Basel, Switzerland (J.E.).'}, {'ForeName': 'Lesly A', 'Initials': 'LA', 'LastName': 'Pearce', 'Affiliation': 'Biostatistics Consultant, Minot, ND (L.A.P.).'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany (H.M.).'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Rudilosso', 'Affiliation': 'Comprehensive Stroke Center, Department of Neuroscience (S.R.), Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'Veroníca V', 'Initials': 'VV', 'LastName': 'Olavarría', 'Affiliation': 'Department of Neurology and Psychiatry, Faculty of Medicine, Universidad del Desarrollo, Clínica Alemana de Santiago, Santiago, Chile (V.V.O.).'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'McMaster University/Population Health Research Institute, Hamilton Health Sciences, ON, Canada (A.S., S.J.C., R.G.H.).'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Chamorro', 'Affiliation': 'Comprehensive Stroke Center, Department of Neuroscience (A.C.), Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Martí-Fàbregas', 'Affiliation': 'Hospital de La Santa Creu Isant Pau, Barcelona, Spain (J.M.-F.).'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Veltkamp', 'Affiliation': 'Imperial College London, United Kingdom (R.V.).'}, {'ForeName': 'Şerefnur', 'Initials': 'Ş', 'LastName': 'Öztürk', 'Affiliation': 'Department of Neurology, Selcuk University Faculty of Medicine, Turkey (S.O.).'}, {'ForeName': 'Turgut', 'Initials': 'T', 'LastName': 'Tatlisumak', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Sweden (T.T.).'}, {'ForeName': 'W Frank', 'Initials': 'WF', 'LastName': 'Peacock', 'Affiliation': 'Baylor College of Medicine, Houston, TX (W.F.P.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Pharmaceuticals Clinical Development Thrombosis, Bayer U.S. LLC, Whippany, NJ (S.D.B.).'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'McMaster University/Population Health Research Institute, Hamilton Health Sciences, ON, Canada (A.S., S.J.C., R.G.H.).'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'McMaster University/Population Health Research Institute, Hamilton Health Sciences, ON, Canada (A.S., S.J.C., R.G.H.).'}]",Stroke,['10.1161/STROKEAHA.119.027995']
965,32525222,Effects of bilateral transcranial direct current stimulation on working memory and global cognition in older patients with remitted major depression: A pilot randomized clinical trial.,"OBJECTIVES
To assess the effects of a 10-day course of bilateral anodal transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on working memory and global cognition in elderly participants with remitted major depressive disorder at 14 days (primary outcome) and 90 days (secondary outcome) post intervention.
DESIGN
Randomized double blind controlled trial (clinicaltrials.gov # NCT02212366).
SETTING
Community dwelling outpatient setting.
PARTICIPANTS
Sixty or older with previous single or recurrent episodes of major depression currently in full remission.
INTERVENTION
A 10 day course of active or sham bilateral DLPFC anodal tDCS.
MEASUREMENTS
(a) Working memory assessed by a computerized N back task, and (b) global cognition assessed by a standard paper and pencil neuropsychological test battery.
RESULTS
Thirty-three participants, (mean (SD) age = 66. 5 (5.7) year) were enrolled, out of which 18 (mean (SD) age = 66. 3 (5.8) year) were randomized to active tDCS and 15 (mean (SD) age = 66. 7 (5.8) years) to sham tDCS. All randomized participants except one from the sham group -completed the tDCS course. There were no differences between the groups on working memory performance or global cognition at 14 or 90 days post intervention. Both groups showed promising changes in working memory and global cognition over time.
CONCLUSIONS
tDCS was well tolerated in older patients with remitted MDD, however, as compared to the sham group, it did not improve working memory or global cognition. Future studies should investigate tDCS with alternative parameters to enhance cognition in this population.",2020,There were no differences between the groups on working memory performance or global cognition at 14 or 90 days post intervention.,"['elderly participants with remitted major depressive disorder at 14\u2009days (primary outcome) and 90\u2009days (secondary outcome) post intervention', 'Thirty-three participants, (mean (SD) age\xa0', 'Community dwelling outpatient setting', 'older patients with remitted MDD', '60 or older with previous single or recurrent episodes of major depression currently in full remission', 'Older Patients with Remitted Major Depression', '5 (5.7) year) were enrolled, out of which 18 (mean (SD) age\xa0=\xa066']","['Bilateral Transcranial Direct Current Stimulation', 'active or sham bilateral DLPFC anodal tDCS', 'tDCS', 'bilateral anodal transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC', 'active tDCS']","['working memory performance or global cognition', 'working memory or global cognition', '1) working memory assessed by a computerized N back task, and 2) global cognition assessed by a standard paper and pencil neuropsychological test battery', 'Working Memory and Global Cognition', 'working memory and global cognition']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}]",,0.222182,There were no differences between the groups on working memory performance or global cognition at 14 or 90 days post intervention.,"[{'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Judah', 'Initials': 'J', 'LastName': 'Batist', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Ghazala', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Reza M', 'Initials': 'RM', 'LastName': 'Zomorrodi', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Brooks', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Goodman', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}]",International journal of geriatric psychiatry,['10.1002/gps.5361']
966,31527700,Effectiveness of hypnosis for pain management and promotion of health-related quality-of-life among people with haemophilia: a randomised controlled pilot trial.,"Joint deterioration and associated chronic pain are common among people with haemophilia (PWH), having an impact on quality-of-life. Though non-pharmacological strategies are recommended, psychological interventions to promote pain control and quality-of-life have scarcely been tested in haemophilia. This randomised controlled pilot trial aimed to assess feasibility, acceptability and effectiveness of hypnosis for pain management and promotion of health-related quality-of-life (HRQoL) among PWH. Twenty adults were randomised either to four weekly hypnosis sessions plus treatment-as-usual (experimental group; EG) or treatment-as-usual only (control group; CG). Participants completed sociodemographic and clinical assessment, measures of pain, HRQoL and emotional distress before (T1) and after (T2) intervention. Changes were analysed by calculating the differences between T1 and T2, and the groups were compared through independent-sample t tests (or chi-squared). Retention rates (90%) and analysis of patient satisfaction showed good acceptability and feasibility of the intervention. The EG (n = 8) had a higher reduction on pain interference than the CG (n = 10) (d = -0.267). A higher improvement on HRQoL (EQ-5D index: d = 0.334; EQ-5D VAS: d = 1.437) and a tendency towards better haemophilia-related quality-of-life (A36-Hemofilia QoL) were also evident in the EG. This is the first study showing the effectiveness of hypnosis to reduce pain interference and promote HRQoL among PWH.",2019,The EG (n = 8) had a higher reduction on pain interference than the CG (n = 10) (d = -0.267).,"['people with haemophilia', 'people with haemophilia (PWH', 'Twenty adults']","['hypnosis', 'hypnosis sessions plus treatment-as-usual (experimental group; EG) or treatment-as-usual only (control group; CG']","['sociodemographic and clinical assessment, measures of pain, HRQoL and emotional distress', 'pain management and promotion of health-related quality-of-life (HRQoL', 'HRQoL (EQ-5D index', 'Retention rates', 'haemophilia-related quality-of-life (A36-Hemofilia QoL', 'pain interference']","[{'cui': 'C1321589', 'cui_str': 'Hemophilia - specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3888013', 'cui_str': 'Hypnotism'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1321589', 'cui_str': 'Hemophilia - specialty'}]",20.0,0.0895966,The EG (n = 8) had a higher reduction on pain interference than the CG (n = 10) (d = -0.267).,"[{'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'Paredes', 'Affiliation': 'Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal.'}, {'ForeName': 'Patrício', 'Initials': 'P', 'LastName': 'Costa', 'Affiliation': 'Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Fernandes', 'Affiliation': 'Centre of Hemophilia, Department of Transfusion Medicine and Blood Bank, São João University Hospital Centre, Porto, Portugal.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Lopes', 'Affiliation': 'Centre of Hemophilia, Department of Transfusion Medicine and Blood Bank, São João University Hospital Centre, Porto, Portugal.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Carvalho', 'Affiliation': 'Centre of Hemophilia, Department of Transfusion Medicine and Blood Bank, São João University Hospital Centre, Porto, Portugal.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Almeida', 'Affiliation': 'Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal.'}, {'ForeName': 'Patrícia Ribeiro', 'Initials': 'PR', 'LastName': 'Pinto', 'Affiliation': 'Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal. patipinto@med.uminho.pt.'}]",Scientific reports,['10.1038/s41598-019-49827-1']
967,32493335,Alogliptin after acute coronary syndrome in patients with type 2 diabetes: a renal function stratified analysis of the EXAMINE trial.,"BACKGROUND
The EXAMINE trial tested the efficacy and safety of alogliptin, an inhibitor of dipeptidyl peptidase 4, compared with placebo in 5380 patients with type 2 diabetes and a recent acute coronary syndrome. Because alogliptin is cleared by the kidney, patients were stratified according to screening renal function within two independently randomized strata: (1) estimated glomerular filtration rate (eGFR) ≥ 60 ml/min/1.73m 2 and (2) eGFR < 60 ml/min/1.73m 2 . We aim to assess the efficacy and safety of alogliptin vs. placebo according to the renal function strata.
METHODS
Cox-proportional hazard models with an interaction term by renal function strata were used. The primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke.
RESULTS
Patient characteristics were balanced within each renal function strata. In total, 3946 patients were randomized within the eGFR ≥ 60 stratum, and 1434 patients within the eGFR < 60 stratum. The effect of alogliptin was modified by the renal function strata.
PRIMARY OUTCOME
eGFR ≥ 60 HR = 0.81, 95%CI, 0.65-0.99, and eGFR < 60 HR = 1.20, 95%CI, 0.95-1.53; interaction p = 0.014. Cardiovascular death: eGFR ≥ 60 HR = 0.61, 95%CI, 0.42-0.88, and eGFR < 60 HR = 1.16, 95%CI, 0.82-1.65; interaction p = 0.013. Non-fatal MI: eGFR ≥ 60 HR = 0.86, 95%CI, 0.66-1.13, and eGFR < 60 HR = 1.48, 95%CI, 1.07-2.06; interaction p = 0.013.
CONCLUSIONS
Alogliptin may benefit patients with eGFR ≥ 60, but may be detrimental to patients with eGFR < 60 ml/min/1.73m 2 . These hypothesis-generating findings require further validation to assess the potential benefit and risk of alogliptin across the renal function spectrum among patients with type 2 diabetes and a recent acute coronary syndrome.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT00968708.",2020,"Cardiovascular death: eGFR ≥ 60 HR = 0.61, 95%CI, 0.42-0.88, and eGFR < 60 HR = 1.16, 95%CI, 0.82-1.65; interaction p = 0.013. Non-fatal MI: eGFR ≥ 60 HR = 0.86, 95%CI, 0.66-1.13, and eGFR < 60 HR = 1.48, 95%CI, 1.07-2.06; interaction p = 0.013.
","['5380 patients with type 2 diabetes and a recent acute coronary syndrome', '3946 patients were randomized within the eGFR ≥\u200960 stratum, and 1434 patients within the eGFR <\u200960 stratum', 'patients with type 2 diabetes and a recent acute coronary syndrome', 'patients with type 2 diabetes']","['alogliptin', 'eGFR', 'alogliptin vs. placebo', 'Alogliptin', 'placebo']","['efficacy and safety', 'composite of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke', 'glomerular filtration rate (eGFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C1958126', 'cui_str': 'alogliptin'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",5380.0,0.140347,"Cardiovascular death: eGFR ≥ 60 HR = 0.61, 95%CI, 0.42-0.88, and eGFR < 60 HR = 1.16, 95%CI, 0.82-1.65; interaction p = 0.013. Non-fatal MI: eGFR ≥ 60 HR = 0.86, 95%CI, 0.66-1.13, and eGFR < 60 HR = 1.48, 95%CI, 1.07-2.06; interaction p = 0.013.
","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France, CHRU de Nancy, Inserm U1116, Nancy, France, FCRIN INI-CRCT, Nancy, France. j.ferreira@chru-nancy.fr.""}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Mehta', 'Affiliation': 'Cytel Corportation, Cambridge, MA, USA.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Division of Cardiology, McGill University Health Centre, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France, CHRU de Nancy, Inserm U1116, Nancy, France, FCRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France, CHRU de Nancy, Inserm U1116, Nancy, France, FCRIN INI-CRCT, Nancy, France.""}]",BMC medicine,['10.1186/s12916-020-01616-8']
968,32144789,Potential strategy for assessing QT/QTc interval for drugs that produce rapid changes in heart rate: Electrocardiographic assessment of the effects of intravenous remimazolam on cardiac repolarization.,"AIMS
Remimazolam is a new, ultra-short-acting benzodiazepine developed for intravenous (IV) use during procedural sedation and in general anaesthesia. Two trials were conducted to characterize its effects on cardiac repolarization.
METHODS
A thorough QT/QTc (TQT) study assessed electrocardiography effects of therapeutic and supratherapeutic doses of remimazolam and midazolam. To investigate whether RR-QT hysteresis effects due to rapid heart rate changes might have confounded the QTc assessments in the TQT trial, a second trial used continuous IV remimazolam infusion to achieve stable heart rates during periods of stable remimazolam plasma concentration.
RESULTS
During the TQT, both compounds produced a 10-20-beats/min increase in heart rate within 30 seconds, persisting for 5-10 minutes. Within 30 seconds, the upper bound of the 2-sided 90% confidence interval for the placebo-corrected change from baseline for QTcI (ΔΔQTcI) exceeded 10 ms for both doses of remimazolam (ΔΔQTcI 7.2 [3.2, 11.2] ms for the 10 mg dose and 10.4 [6.5, 14.3] ms for the 20 mg dose) as well as for the 7.5-mg dose of midazolam (8.2 [4.4, 12.1] ms). At 2 minutes after IV bolus, the upper bound of the 2-sided 90% confidence interval for ΔΔQTcI exceeded 10 ms only for the remimazolam 20-mg dose (6.3 [2.3, 10.2] ms). During the second study, during periods of stable heart rate, remimazolam had no clinically significant effect on QTc (peak ΔΔQTcI 3.4 [-1.1, 7.6] ms).
CONCLUSION
Remimazolam does not prolong cardiac repolarization (QTc). The methods reported here may allow assessment of the QTc effects of other drugs given by IV bolus.",2020,Remimazolam does not prolong cardiac repolarization (QTc).,[],"['midazolam', 'remimazolam and midazolam', 'QT/QTc', 'remimazolam', 'benzodiazepine', 'Remimazolam']","['cardiac repolarization', 'QTc', 'cardiac repolarization (QTc', 'heart rate']",[],"[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C3179470', 'cui_str': 'remimazolam'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.0724755,Remimazolam does not prolong cardiac repolarization (QTc).,"[{'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Kleiman', 'Affiliation': 'eResearch Technology, Philadelphia, PA, USA.'}, {'ForeName': 'Borje', 'Initials': 'B', 'LastName': 'Darpo', 'Affiliation': 'eResearch Technology, Philadelphia, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thorn', 'Affiliation': 'Statistical Resources, Chapel Hill, NC, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stoehr', 'Affiliation': 'Paion Germany GmbH, Aachen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schippers', 'Affiliation': 'Paion Germany GmbH, Aachen, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.14270']
969,32498755,Effects of slow- v. fast-digested protein supplementation combined with mixed power training on muscle function and functional capacities in older men.,"Ageing leads to a progressive loss of muscle function (MF) and quality (MQ: muscle strength (MS)/lean muscle mass (LM)). Power training and protein (PROT) supplementation have been proposed as efficient interventions to improve MF and MQ. Discrepancies between results appear to be mainly related to the type and/or dose of proteins used. The present study aimed at determining whether or not mixed power training (MPT) combined with fast-digested PROT (F-PROT) leads to greater improvements in MF and MQ in elderly men than MPT combined with slow-digested PROT (S-PROT) or MPT alone. Sixty elderly men (age 69 (sd 7) years; BMI 18-30 kg/m2) were randomised into three groups: (1) placebo + MPT (PLA; n 19); (2) F-PROT + MPT (n 21) and (3) S-PROT + MPT (n 20) completed the intervention. LM, handgrip and knee extensor MS and MQ, functional capacity, serum metabolic markers, skeletal muscle characteristics, dietary intake and total energy expenditure were measured. The interventions consisted in 12 weeks of MPT (3 times/week; 1 h/session) combined with a supplement (30 g:10 g per meal) of F-PROT (whey) or S-PROT (casein) or a placebo. No difference was observed among groups for age, BMI, number of steps and dietary intake pre- and post-intervention. All groups improved significantly their LM, lower limb MS/MQ, functional capacity, muscle characteristics and serum parameters following the MPT. Importantly, no difference between groups was observed following the MPT. Altogether, adding 30 g PROT/d to MPT, regardless of the type, does not provide additional benefits to MPT alone in older men ingesting an adequate (i.e. above RDA) amount of protein per d.",2020,"No difference was observed among groups for age, BMI, number of steps and dietary intake pre- and post-intervention.","['Sixty elderly men (Age:69±7years; BMI:18-30kg.m-2', 'elderly men than MPT combined with slow-digested PROT (S-PROT) or MPT alone']","['MPT (3-times/week;1h/session) combined with a supplement (30g: 10g per meal) of F-PROT (whey) or S-PROT (casein) or a Placebo', 'Placebo+MPT (PLA; n=19); 2) F-PROT+MPT', 'S-PROT+MPT', 'not mixed power training (MPT) combined with fast-digested PROT (F-PROT', 'Power training and protein (PROT) supplementation']","['LM, and lower limb MS/MQ, functional capacity, muscle characteristics and serum parameters', 'LM, handgrip and knee extensor MS and MQ, functional capacity, serum metabolic markers, skeletal muscle characteristics, dietary intake and total energy expenditure']","[{'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}]",60.0,0.0199228,"No difference was observed among groups for age, BMI, number of steps and dietary intake pre- and post-intervention.","[{'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Dulac', 'Affiliation': 'Département de Biologie, Faculté des sciences, Université du Québec à Montréal, Montréal, QC, Canada, H2X 1Y4.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Pion', 'Affiliation': 'Département de Biologie, Faculté des sciences, Université du Québec à Montréal, Montréal, QC, Canada, H2X 1Y4.'}, {'ForeName': 'F C', 'Initials': 'FC', 'LastName': 'Lemieux', 'Affiliation': ""Département des sciences de l'activité physique, Faculté des sciences, Université du Québec à Montréal, Montréal, QC, Canada, H2X 1Y4.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pinheiro Carvalho', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada, H3W 1W6.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'El Hajj Boutros', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada, H3W 1W6.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bélanger', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada, H3W 1W6.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gaudreau', 'Affiliation': 'Department of Medicine, University of Montreal, Montréal, QC, Canada, H3G 2M1.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chevalier', 'Affiliation': 'Department of Medicine, McGill University Health Centre-Research Institute, McGill University, Montréal, QC, Canada, H3H 2L9.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Morais', 'Affiliation': 'Department of Medicine, McGill University Health Centre-Research Institute, McGill University, Montréal, QC, Canada, H3H 2L9.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Noirez', 'Affiliation': ""Département des sciences de l'activité physique, Faculté des sciences, Université du Québec à Montréal, Montréal, QC, Canada, H2X 1Y4.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gouspillou', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada, H3W 1W6.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aubertin-Leheudre', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada, H3W 1W6.""}]",The British journal of nutrition,['10.1017/S0007114520001932']
970,32497219,The effect of metformin vs placebo on sex hormones in CCTG MA.32.,"BACKGROUND
Metformin has been associated with lower breast cancer risk and improved outcomes in observational studies. Multiple biologic mechanisms have been proposed, including a recent report of altered sex hormones (SHs). We evaluated the effect of metformin on SHs in MA.32, a phase III trial of nondiabetic BC subjects randomized to metformin or placebo.
METHODS
We studied the subgroup of post-menopausal hormone receptor negative BC subjects not receiving endocrine treatment who provided fasting blood at baseline and at 6 months after randomization. Sex hormone binding globulin (SHBG), bioavailable testosterone (BT) and estradiol levels were assayed using ECLIA (electrochemiluminescense immunoassay). Change from baseline to 6 months between study arms was compared using Wilcoxon sum rank tests and regression models.
RESULTS
312 women were eligible (141 metformin vs 171 placebo); the majority of subjects in each arm had T1/2, N0, HER2 negative BC and had received (neo)adjuvant chemotherapy. Mean age ± SD was 58.1±6.9 vs 57.5±7.9 years, mean BMI was 27.3±5.2 vs 28.9±6.4 kg/m2 for metformin vs placebo respectively. Median estradiol decreased between baseline and 6 months on metformin vs placebo (-5.7 vs 0 pmol/L; p < 0.001) in univariable analysis and after controlling for baseline BMI and BMI change (p < 0.001). There was no change in SHBG or BT.
CONCLUSION
Metformin lowered estradiol levels, independent of BMI. This observation suggests a new metformin effect that has potential relevance to estrogen sensitive cancers.",2020,"There was no change in SHBG or BT.
","['subgroup of post-menopausal hormone receptor negative BC subjects not receiving endocrine treatment who provided fasting blood at baseline and at 6 months after randomization', '312 women were eligible (141 metformin vs 171 placebo); the majority of subjects in each arm had T1/2, N0, HER2 negative BC and had received (neo)adjuvant chemotherapy', 'nondiabetic BC subjects']","['Metformin', 'metformin or placebo', 'metformin', 'metformin vs placebo', 'placebo']","['estradiol levels', 'Sex hormone binding globulin (SHBG), bioavailable testosterone (BT) and estradiol levels', 'Median estradiol', 'SHBG or BT', 'Mean age ± SD', 'mean BMI', 'baseline BMI and BMI change']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0370051', 'cui_str': 'Bioavailable testosterone'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",312.0,0.209572,"There was no change in SHBG or BT.
","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Pimentel', 'Affiliation': 'Vall d`Hebron Institute of Oncology (VHIO), Barcelona, Spain.'}, {'ForeName': 'Bingshu E', 'Initials': 'BE', 'LastName': 'Chen', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University - Cancer Research Institute, Kingston ON, Canada.""}, {'ForeName': 'Ana Elisa', 'Initials': 'AE', 'LastName': 'Lohmann', 'Affiliation': 'University of Western Ontario, ON Canada.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Ennis', 'Affiliation': 'Applied Statistician, 9227, Kennedy Road, Markham; ON, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ligibel', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Shepherd', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University - Cancer Research Institute, Kingston ON, Canada.""}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': 'Herbert Irving Cancer Center, Columbia University, New York, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Whelan', 'Affiliation': 'Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton ON, Canada.'}, {'ForeName': 'Vuk', 'Initials': 'V', 'LastName': 'Stambolic', 'Affiliation': 'University Health Network, Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Mayer', 'Affiliation': 'Vanderbilt University, Vanderbilt - Ingram Cancer Center, Nashville TN, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Hobday', 'Affiliation': 'Mayo Clinic, Rochester, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lemieux', 'Affiliation': 'CHA-Hopital Du St-Sacrement, Hopital Enfant Jesus Site, Quebec City, Canada.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh PA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'BCCA - Vancouver Cancer Centre, Vancouver BC, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rea', 'Affiliation': 'Institute of Cancer Research, Clinical Trials and Statistics Unit, Sutton, UK.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Rabaglio', 'Affiliation': 'IBCSG Coordinating Centre, Bern, Switzerland.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ellard', 'Affiliation': 'BCCA - Cancer Centre for the Southern Interior, Kelowna BC, Canada.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Mates', 'Affiliation': 'Cancer Centre of Southeastern Ontario, Kingston ON, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bedard', 'Affiliation': 'University Health Network, Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Pitre', 'Affiliation': 'Health Sciences North, Sudbury ON, Canada.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Vandenberg', 'Affiliation': 'London Regional Cancer Program, London ON, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Jo Dowling', 'Affiliation': 'University Health Network, Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Parulekar', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University - Cancer Research Institute, Kingston ON, Canada.""}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Goodwin', 'Affiliation': 'Lunenfeld Tanenbaum Research Institute at Mount Sinai Hospital, University of Toronto, Canada.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djaa082']
971,32506233,Does acute stress influence the Pavlovian-to-instrumental transfer effect? Implications for substance use disorders.,"RATIONAL
The ability of conditioned stimuli to affect instrumental responding is a robust finding from animal as well as human research and is assumed as a key factor regarding the development and maintenance of addictive behaviour.
OBJECTIVES
While it is well known that stress is an important factor for relapse after treatment, little is known about the impact of stress on conditioned substance-associated stimuli and their influence on instrumental responding.
METHODS
We administered in the present study a Pavlovian-to-instrumental transfer (PIT) paradigm with stimuli associated with smoking- and chocolate-related rewards using points in a token economy to light to moderate smokers who also indicated to like eating chocolate. After completion of the first two phases of the PIT paradigm (i.e. Pavlovian training and instrumental trainings), participants were randomly allocated to the socially evaluated cold pressor test or a control condition before the final phase of the PIT paradigm, the transfer phase, was administered.
RESULTS
The presentation of a smoking-related stimulus enhanced instrumental responding for a smoking-related reward (i.e. 'smoking-PIT' effect) and presentation of a chocolate-related stimulus for a chocolate-related reward (i.e. 'chocolate-PIT' effect) in participants aware of the experimental contingencies as indicated by expectancy ratings. However, acute stress did not change (i.e. neither enhanced nor attenuated) the 'smoking-PIT' effect or the 'chocolate-PIT' effect, and no overall effect of acute stress on tobacco choice was observed in aware participants.
CONCLUSIONS
The established role of stress in addiction appears not to be driven by an augmenting effect on the ability of drug stimuli to promote drug-seeking.",2020,"However, acute stress did not change (i.e. neither enhanced nor attenuated) the 'smoking-PIT' effect or the 'chocolate-PIT' effect, and no overall effect of acute stress on tobacco choice was observed in aware participants.
",[],"['PIT paradigm (i.e. Pavlovian training and instrumental trainings', 'socially evaluated cold pressor test', 'Pavlovian-to-instrumental transfer (PIT) paradigm with stimuli associated with smoking- and chocolate-related rewards using points']","['acute stress', 'tobacco choice']",[],"[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]",,0.0217592,"However, acute stress did not change (i.e. neither enhanced nor attenuated) the 'smoking-PIT' effect or the 'chocolate-PIT' effect, and no overall effect of acute stress on tobacco choice was observed in aware participants.
","[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Steins-Loeber', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Otto-Friedrich-University of Bamberg, Markusplatz 3, 96047, Bamberg, Germany. sabine.steins-loeber@uni-bamberg.de.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lörsch', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Otto-Friedrich-University of Bamberg, Markusplatz 3, 96047, Bamberg, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'van der Velde', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Otto-Friedrich-University of Bamberg, Markusplatz 3, 96047, Bamberg, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Müller', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Brand', 'Affiliation': 'Department of General Psychology: Cognition, University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Duka', 'Affiliation': 'Sussex Addiction Research and Intervention Centre, School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Ruhr University Bochum, Bochum, Germany.'}]",Psychopharmacology,['10.1007/s00213-020-05534-8']
972,32507421,"Efficacy of the plantago major L. syrup on radiation induced oral mucositis in head and neck cancer patients: A randomized, double blind, placebo-controlled clinical trial.","INTRODUCTION
Oral mucositis is a complication of radiation therapy in cancer patients. We designed a trial to evaluate efficacy of plantago major on symptoms of radiation induced mucositis in cancer patients.
METHODS
In this randomized double blind, placebo-controlled trial 23 patients received plantago major syrup as intervention group and 23 patients received placebo syrup as control group for 7 weeks. Outcome measures were severity of mucositis according to WHO scale and severity of patients' pain assessed by visual analogue scale.
RESULTS
Severity of mucositis were significantly lower in intervention group compared to placebo group (p value<0.05). Also patients in intervention group experienced significantly less pain compared to placebo group during radiotherapy period (p value<0.05) CONCLUSION: Plantago major L syrup was effective on the reduction of the symptoms of radiation induced mucositis in patients with head and neck cancers.",2020,"RESULTS
Severity of mucositis were significantly lower in intervention group compared to placebo group (p value<0.05).","['head and neck cancer patients', 'cancer patients', 'patients with head and neck cancers']","['placebo syrup', 'plantago major syrup', 'plantago major L. syrup', 'Plantago major L syrup', 'placebo']","['Severity of mucositis', ""severity of mucositis according to WHO scale and severity of patients' pain assessed by visual analogue scale"", 'oral mucositis', 'pain']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C3488573', 'cui_str': 'Plantago major extract'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]",,0.29297,"RESULTS
Severity of mucositis were significantly lower in intervention group compared to placebo group (p value<0.05).","[{'ForeName': 'Gholamreza Mohammad', 'Initials': 'GM', 'LastName': 'Soltani', 'Affiliation': 'Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Arak, Iran. Electronic address: Gsoltani@arakmu.ac.ir.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Hemati', 'Affiliation': 'Department of Radiation Oncology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: hematti@med.mui.ac.ir.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Sarvizadeh', 'Affiliation': 'Department of Radiation Oncology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: sarvizadeh83@arakmu.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamalinejad', 'Affiliation': 'School of Pharmacy, Shahid Beheshti University of Medical Science, Tehran, Iran. Electronic address: mkamalinejad@sbmu.ac.ir.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Tafazoli', 'Affiliation': 'Department of Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: Stud4469948004@sums.ac.ir.'}, {'ForeName': 'Seied AmirHossein', 'Initials': 'SA', 'LastName': 'Latifi', 'Affiliation': 'Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Arak, Iran. Electronic address: Sah.latifi@arakmu.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102397']
973,32510734,"Azithromycin and COVID-19: Prompt early use at first signs of this infection in adults and children, an approach worthy of consideration.","The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19. Initial enthusiasm for the combination of hydroxychloroquine and azithromycin has abated. However, as a result of positive clinical experience with azithromycin used alone during the first few days of the flu-like illness caused by this coronavirus, we recommend formal clinical trials using azithromycin early in the course of a COVID-19 infection. There is one clinical trial initiated, the individually randomized, telemedicine-based, ""Azithromycin for COVID-19 Treatment in Outpatients Nationwide"" based at the University of California San Francisco. This placebo-controlled trial is designed to determine the efficacy of a single 1.2-g dose of oral azithromycin to prevent COVID-19 patient progression to hospitalization. We recommend formal clinical trials of azithromycin in its prepackaged form at the first sign of COVID-19 infection in adults and children, using an initial adult dose of 500 mg followed by 250 mg per day for 4 days, a total cumulative dose of 1.5 g, and for children 5 to 18 years of age, 10 mg/kg on the first day followed by 5 mg/kg for 4 days.",2020,The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19.,"['Adults and Children', 'Outpatients Nationwide (ACTION)"" based at the University of California San Francisco', 'adults and children']","['hydroxychloroquine and azithromycin', 'telemedicine-based, ""Azithromycin', 'Azithromycin', 'azithromycin', 'placebo']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0479328,The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schwartz', 'Affiliation': 'Professor of Dermatology and Pathology, Rutgers University New Jersey Medical School, Newark, New Jersy, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Suskind', 'Affiliation': 'Professor of Pediatrics and Founding Dean Emeritus, California University of Science of Medicine, San Bernardino, California, USA.'}]",Dermatologic therapy,['10.1111/dth.13785']
974,32506227,"The efficacy in treatment of facial melasma with thulium 1927-nm fractional laser-assisted topical tranexamic acid delivery: a split-face, double-blind, randomized controlled pilot study.","This split-face, double-blind, randomized controlled study examines the efficacy of fractional thulium laser (FTL)-assisted delivery of topical tranexamic acid (TXA) compared with FTL alone as a treatment option for melasma. Forty-six adults with Fitzpatrick skin types III-V and recalcitrant melasma underwent four weekly treatments with fractional 1927-nm thulium laser on both sides of the face. Immediately after treatment, TXA was applied to one side of the face and normal saline solution (NSS) to the contralateral side as control under occlusion. Melanin index (MI), modified MASI (mMASI), and patients' self-assessed improvement scores were measured at baseline, 1 week, 4 weeks, and 3- and 6 months after the final treatment and were examined statistically with a paired sample t test with significance set at p ≤ 0.05. The majority of the participants (95.7%, n = 44) were female with Fitzpatrick skin type IV (82.6%) and a mean age of 48.0 ± 10.0 years. Twenty-nine individuals were able to be followed up until the 6-month assessment. Significant improvement from baseline was seen in both the MI and mMASI scores for both the TXA and control sides at 3 months, with no statistically significant difference between sides. By the 6th month, significant differences in MI and mMASI scores from baseline were still noted, except in the MI for controls. The patients' self-assessment showed similar patterns. No serious adverse events were reported for either group. A regimen of FTL-assisted delivery of TXA over a 4-week period is a safe and effective treatment option for melasma, producing significant improvement up to 3 months. Results further would suggest a repeat regimen every 3 months could be useful for treatment of recalcitrant melasma.",2020,"Significant improvement from baseline was seen in both the MI and mMASI scores for both the TXA and control sides at 3 months, with no statistically significant difference between sides.","['participants (95.7%, n = 44) were female with Fitzpatrick skin type IV (82.6%) and a mean age of 48.0 ± 10.0 years', 'facial melasma with thulium 1927-nm', 'melasma', 'Forty-six adults with Fitzpatrick skin types III-V and recalcitrant melasma', 'Twenty-nine individuals']","['fractional 1927-nm thulium laser', 'TXA', 'fractional thulium laser (FTL)-assisted delivery of topical tranexamic acid (TXA', 'fractional laser-assisted topical tranexamic acid delivery', 'normal saline solution (NSS', 'FTL alone', 'FTL']","['MI and mMASI scores', 'serious adverse events', ""Melanin index (MI), modified MASI (mMASI), and patients' self-assessed improvement scores""]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441732', 'cui_str': 'Type 4'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0877233', 'cui_str': 'Assisted delivery'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",46.0,0.0463113,"Significant improvement from baseline was seen in both the MI and mMASI scores for both the TXA and control sides at 3 months, with no statistically significant difference between sides.","[{'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, 2 Pran-nok Road, Bangkok, 10700, Thailand. rungsima.wan@mahidol.ac.th.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Sy-Alvarado', 'Affiliation': 'Section of Dermatology, Department of Medicine, Philippine General Hospital, University of the Philippines, Manila, Philippines.'}, {'ForeName': 'Poramin', 'Initials': 'P', 'LastName': 'Patthamalai', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, 2 Pran-nok Road, Bangkok, 10700, Thailand.'}, {'ForeName': 'Thanya', 'Initials': 'T', 'LastName': 'Techapichetvanich', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, 2 Pran-nok Road, Bangkok, 10700, Thailand.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Eimpunth', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, 2 Pran-nok Road, Bangkok, 10700, Thailand.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, 2 Pran-nok Road, Bangkok, 10700, Thailand.'}]",Lasers in medical science,['10.1007/s10103-020-03045-8']
975,32514794,"Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study.","INTRODUCTION
Many commercially available glucagon products for treatment of severe hypoglycaemia require cumbersome reconstitution and potentially intimidating injection during an emergency. Nasal glucagon (NG) is a novel drug-device combination product consisting of a single-use dosing device that delivers glucagon dry powder through nasal administration. The present study assessed whether 3 mg NG was non-inferior to 1 mg intramuscular glucagon (IMG) in adults with type 1 diabetes.
METHODS
This randomised, open-label, two-period, crossover trial was conducted at two clinical sites. Hypoglycaemia (plasma glucose [PG] target of < 3.3 mmol/l (60 mg/dl) was induced by an intravenous insulin infusion. Glucagon preparations were given by study staff. Treatment success was defined as an increase in PG to ≥ 3.9 mmol/l (70 mg/dl) or an increase of ≥ 1.1 mmol/l (20 mg/dl) from the PG nadir within 30 min of receiving glucagon.
RESULTS
Of the 66 participants included in the primary efficacy analysis who received both NG and IMG, 100% achieved treatment success, thus demonstrating non-inferiority of NG to IMG. All participants achieved treatment success within 25 min with the mean time to treatment success of 11.4 min (NG) and 9.9 min (IMG). No serious adverse events occurred. Forty-eight treatment-emergent adverse events (TEAEs) occurred after NG and 51 after IMG. Most TEAEs were mild and transient.
CONCLUSION
Nasal glucagon was as efficacious and well tolerated as IMG for the treatment of insulin-induced hypoglycaemia in adults and will be as useful as IMG as a rescue treatment for severe hypoglycaemia.
TRIAL REGISTRATION
NCT03339453, ClinicalTrials.gov.",2020,All participants achieved treatment success within 25 min with the mean time to treatment success of 11.4 min (NG) and 9.9 min (IMG).,"['adults with type 1 diabetes', 'Adults With Type 1 Diabetes']","['Insulin-Induced Hypoglycaemia', 'Glucagon preparations', 'Glucagon', 'Nasal glucagon', 'intramuscular glucagon (IMG', 'Nasal glucagon (NG']",['Hypoglycaemia (plasma glucose [PG'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",,0.229767,All participants achieved treatment success within 25 min with the mean time to treatment success of 11.4 min (NG) and 9.9 min (IMG).,"[{'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'Suico', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA. suico_jeffrey_gideon@lilly.com.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Hövelmann', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Shen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Bergman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sherr', 'Affiliation': 'Endocrinology, Department of Pediatrics (Endocrinology), Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Frier', 'Affiliation': ""The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil, Mainz, Germany.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00845-7']
976,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE
Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended.
METHOD
To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website.
RESULTS
Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
CONCLUSION
Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177']
977,32522156,Efficacy of electrical stimulation on epidural anesthesia for cesarean section: a randomized controlled trial.,"BACKGROUND
Loss of resistance (LOR) technique is a widely used method to identify the epidural space. However, cases of inadequate epidural anesthesia in cesarean section were frequently reported. Also, the success rate of epidural anesthesia with LOR technique varied depending on the proficiency of the practitioner. The purpose of this study was to assess the efficacy and safety of electrical stimulation to identify epidural spaces in cesarean section for novices or clinicians with recent gap in experience.
METHODS
Pregnant women scheduled for elective cesarean section were randomly allocated to two groups. Groups were classified based on the methods used for identifying the epidural space: the LOR group (group L) and the LOR with epidural electrical stimulation group (group E). Clinicians with less than 10 epidural cesarean section experiences in the recent year performed epidural anesthesia for cesarean section. In the group E, a RegionalStim® conductive catheter was inserted through the Tuohy needle, and the guidewire passing through the catheter was connected to a peripheral nerve stimulator. The intensity of the stimulation was gradually increased from 0.25 mA to 1.5 mA until paresthesia was elicited and radiated. We assessed the success of epidural anesthesia (complete success, partial success or failure). Other clinical parameters including maternal satisfaction, time required for epidural anesthesia, neonatal Apgar scores, pain scores and adverse events were compared between the two groups.
RESULTS
Except for 6 patients who withdrew consent, 54 patients were enrolled in this study (28 for the group L and 26 for the group E). The demographic data showed no difference between the two groups. There was no adverse event resulted from electrical stimulation. The group E showed higher rate of complete success, sensitivity in finding epidural space and maternal satisfaction compared to the group L (21/26 vs. 15/28, p = 0.034, 0.96 vs. 0.68, p = 0.012 and 4.04 vs. 3.39, p = 0.02, respectively). The other clinical parameters showed no differences between the two groups.
CONCLUSION
In addition to the conventional LOR technique, identifying epidural spaces using electrical stimulation led to better outcomes without additional risks for novices as well as clinicians with recent gap in experience.
TRIAL REGISTRATION
This study was retrospectively registered in the ClinicalTrials.gov Registry (NCT03443466) on February 23, 2018.",2020,"The group E showed higher rate of complete success, sensitivity in finding epidural space and maternal satisfaction compared to the group L (21/26 vs. 15/28, p = 0.034, 0.96 vs. 0.68, p = 0.012 and 4.04 vs. 3.39, p = 0.02, respectively).","['Clinicians with less than 10 epidural cesarean section experiences in the recent year performed epidural anesthesia for cesarean section', '6 patients who withdrew consent, 54 patients were enrolled in this study (28 for the group L and 26 for the group E', 'cesarean section for novices or clinicians with recent gap in experience', 'epidural anesthesia for cesarean section', 'Pregnant women scheduled for elective cesarean section']","['electrical stimulation', 'conventional LOR technique', 'LOR with epidural electrical stimulation']","['higher rate of complete success, sensitivity in finding epidural space and maternal satisfaction', 'success of epidural anesthesia (complete success, partial success or failure', 'efficacy and safety', 'intensity of the stimulation', 'maternal satisfaction, time required for epidural anesthesia, neonatal Apgar scores, pain scores and adverse events']","[{'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441846', 'cui_str': 'Group L'}, {'cui': 'C0441839', 'cui_str': 'Group E'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0587268', 'cui_str': 'Loss of resistance technique'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0014537', 'cui_str': 'Structure of epidural space'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",54.0,0.087104,"The group E showed higher rate of complete success, sensitivity in finding epidural space and maternal satisfaction compared to the group L (21/26 vs. 15/28, p = 0.034, 0.96 vs. 0.68, p = 0.012 and 4.04 vs. 3.39, p = 0.02, respectively).","[{'ForeName': 'Young Sung', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, 148 Gurodong-ro, Guro-gu, Seoul, 08308, South Korea.'}, {'ForeName': 'Hyo Sung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, 148 Gurodong-ro, Guro-gu, Seoul, 08308, South Korea.'}, {'ForeName': 'Hyerim', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, 148 Gurodong-ro, Guro-gu, Seoul, 08308, South Korea.'}, {'ForeName': 'Chung Hun', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, 148 Gurodong-ro, Guro-gu, Seoul, 08308, South Korea.'}, {'ForeName': 'Mi Kyoung', 'Initials': 'MK', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, 148 Gurodong-ro, Guro-gu, Seoul, 08308, South Korea.'}, {'ForeName': 'Sang Sik', 'Initials': 'SS', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, 148 Gurodong-ro, Guro-gu, Seoul, 08308, South Korea. clonidine@empal.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01063-1']
978,31326680,Design and rationale of a pragmatic trial integrating routine screening for atrial fibrillation at primary care visits: The VITAL-AF trial.,"Given the preventable morbidity and mortality associated with atrial fibrillation (AF), increased awareness of undiagnosed AF, and advances in mobile electrocardiogram (ECG) technology, there is a critical need to assess the effectiveness of using such technology to routinely screen for AF in clinical practice. VITAL-AF is a pragmatic trial that will test whether screening for AF using a single-lead handheld ECG in individuals 65 years or older during primary care visits will lead to an increased rate of AF detection. The study is a cluster-randomized trial, with 8 primary care practices randomized to AF screening and 8 primary care practices randomized to usual care. We anticipate studying approximately 16,000 patients in each arm. During the 1-year enrollment period, practice medical assistants will screen eligible patients who agree to participate during office visits using a single-lead ECG device. Automated screening results are documented in the electronic health record, and patients can discuss screening results with their provider during the scheduled visit. All single-lead ECGs are overread by a cardiologist. Screen-detected AF is managed at the discretion of the patient's physician. The primary study end point is incident AF during the screening period. Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start. Outcomes are ascertained based on electronic health record documentation and are manually adjudicated. The results of this pragmatic trial may help identify a model for widespread adoption of AF screening as part of routine clinical practice.",2019,"Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start.","['atrial fibrillation at primary care visits', '16,000 patients in each arm', 'individuals 65 years or older during primary care visits', 'eligible patients who agree to participate during office visits using a single-lead ECG device']",['AF screening'],"['new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage']","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0028900', 'cui_str': 'Office Visits'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",,0.0527347,"Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start.","[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Ashburner', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Atlas', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'McManus', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School, Worcester, MA.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Ana T', 'Initials': 'AT', 'LastName': 'Trisini Lipsanopoulos', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Leila H', 'Initials': 'LH', 'LastName': 'Borowsky', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Wyliena', 'Initials': 'W', 'LastName': 'Guan', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Ellinor', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Singer', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Lubitz', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA. Electronic address: slubitz@mgh.harvard.edu.'}]",American heart journal,['10.1016/j.ahj.2019.06.011']
979,32500717,Impact of Acamprosate on Chronic Tinnitus: A Randomized-Controlled Trial.,"OBJECTIVES
Tinnitus is a common and distressing otologic symptom, with various probable pathophysiologic mechanisms, such as an imbalance between excitatory and inhibitory mechanisms. Acamprosate, generally used to treat alcoholism, is a glutaminergic antagonist and GABA agonist suggested for treating tinnitus. Thus, we aimed to evaluate the efficacy and safety of acamprosate in the treatment of tinnitus.
METHODS
The current randomized-controlled trial study included 20 subjects with chronic tinnitus. After performing psycho-acoustic, psychometric and electrophysiological evaluations, all studied tinnitus subjects were randomly divided into two groups of acamprosate and placebo. The first group received oral acamprosate (two tablets of 333 mg/d, three times a day), whereas the second group was given placebo treatment (two tablets, three times a day). After the first 30 days, all evaluations were repeated for the studied groups just in the same manner before the study. Subsequently, the final results of each evaluation were compared together with the baseline values.
RESULTS
Nine studied subjects randomly received acamprosate, whereas eleven others received a placebo. There was no significant improvement in the psycho-acoustic tests, except a decrease was observed in the pitch match of tinnitus ( P = .039). For those subjects who were receiving acamprosate, a significant reduction was observed in tinnitus handicap inventory ( P = .006), tinnitus questionnaire scores ( P = .007), and the visual analog scores ( P = .007) compared to the placebo group. There was a significant reduction in Action Potential latency ( P = .048) as well as an increase in the amplitude of distortion product otoacoustic emissions at 4 kHz ( P = .048).
CONCLUSIONS
The study results indicated a subjective relief of tinnitus as well as some degree of the electrophysiological improvement at the level of the cochlear and the distal portion of the auditory nerve among the subjects who received the acamprosate.
CLINICAL TRIAL REGISTRATION CODE
IRCT2013121115751N1.",2020,"There was no significant improvement in the psycho-acoustic tests, except a decrease was observed in the pitch match of tinnitus ( P = .039).","['20 subjects with chronic tinnitus', 'Chronic Tinnitus']","['Acamprosate', 'oral acamprosate', 'acamprosate and placebo', 'acamprosate', 'placebo']","['pitch match of tinnitus', 'Action Potential latency', 'tinnitus questionnaire scores', 'amplitude of distortion product otoacoustic emissions', 'subjective relief of tinnitus', 'psycho-acoustic tests', 'efficacy and safety', 'tinnitus handicap inventory', 'visual analog scores']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}]","[{'cui': 'C0284941', 'cui_str': 'acamprosate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0001272', 'cui_str': 'Action Potentials'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0162525', 'cui_str': 'Spontaneous Otoacoustic Emissions'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",20.0,0.0489289,"There was no significant improvement in the psycho-acoustic tests, except a decrease was observed in the pitch match of tinnitus ( P = .039).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Farhadi', 'Affiliation': 'ENT and Head & Neck Research Center and Department, the Five Senses Health Institute, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Mahdi', 'Initials': 'MM', 'LastName': 'Salem', 'Affiliation': 'ENT and Head & Neck Research Center and Department, the Five Senses Health Institute, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alimohamad', 'Initials': 'A', 'LastName': 'Asghari', 'Affiliation': 'Skull Base Research Center, Rasoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Daneshi', 'Affiliation': 'ENT and Head & Neck Research Center and Department, the Five Senses Health Institute, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mirsalehi', 'Affiliation': 'ENT and Head & Neck Research Center and Department, the Five Senses Health Institute, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Mahmoudian', 'Affiliation': 'ENT and Head & Neck Research Center and Department, the Five Senses Health Institute, Iran University of Medical Sciences, Tehran, Iran.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489420930773']
980,32500725,Evaluation of the Switch From Amiodarone to Dronedarone in Patients With Atrial Fibrillation: Results of the ARTEMIS AF Studies.,"BACKGROUND
Switching between antiarrhythmic drugs is timed to minimize arrhythmia recurrence and adverse reactions. Dronedarone and amiodarone have similar electrophysiological profiles; however, little is known about the optimal timing of switching, given the long half-life of amiodarone.
METHODS
The ARTEMIS atrial fibrillation (AF) Loading and Long-term studies evaluated switching patients with paroxysmal/persistent AF from amiodarone to dronedarone. Patients were randomized based on the timing of the switch: immediate, after a 2-week, or after a 4-week washout of amiodarone. Patients who did not convert to sinus rhythm after amiodarone loading underwent electrical cardioversion. The primary objectives were, for the Loading study, to evaluate recurrence of AF ≤60 days; and for the Long-term study, to profile the pharmacokinetics of dronedarone and its metabolite according to different timings of dronedarone initiation.
RESULTS
In ARTEMIS AF Loading, 176 were randomized (planned 768) after a 28 ± 2 days load of oral amiodarone. Atrial fibrillation recurrence trended less in the immediate switch versus 4-week washout group (hazard ratio [HR] = 0.65 [97.5% CI: 0.34-1.23]; P = .14) and in the 2-week washout versus the 4-week washout group (HR = 0.75 [97.5% CI: 0.41-1.37]; P = .32). In ARTEMIS AF Long-term, 108 patients were randomized (planned 105). Pharmacokinetic analyses (n = 97) showed no significant differences for dronedarone/SR35021 exposures in the 3 groups.
CONCLUSION
The trial was terminated early due to poor recruitment and so our findings are limited by low numbers. However, immediate switching from amiodarone to dronedarone appeared to be well tolerated and safe.",2020,"Pharmacokinetic analyses (n = 97) showed no significant differences for dronedarone/SR35021 exposures in the 3 groups.
","['108 patients were randomized (planned 105', 'Patients With Atrial Fibrillation', 'Patients who did not convert to sinus rhythm after amiodarone loading underwent electrical cardioversion', 'patients with paroxysmal/persistent AF from']","['dronedarone', 'amiodarone to dronedarone', 'amiodarone', 'Dronedarone', 'Amiodarone']","['Atrial fibrillation recurrence', 'tolerated and safe']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C0766326', 'cui_str': 'dronedarone'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",108.0,0.0279373,"Pharmacokinetic analyses (n = 97) showed no significant differences for dronedarone/SR35021 exposures in the 3 groups.
","[{'ForeName': 'Gerald V', 'Initials': 'GV', 'LastName': 'Naccarelli', 'Affiliation': 'Division of Cardiology, Heart and Vascular Institute, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Camm', 'Affiliation': ""Cardiology Clinical Academic Group Molecular & Clinical Sciences Institute, St George's University of London, London, UK.""}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Le Heuzey', 'Affiliation': 'Hôpital Européen Georges Pompidou, Université Paris V René Descartes, Paris, France.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Lombardi', 'Affiliation': 'Cardiologia, Fondazione IRCCS Ospedale Maggiore Policlinico, Milan, Italy.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Tamargo', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Medicine, CIBERCV, University Complutense, Madrid, Spain.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Martinez', 'Affiliation': 'Sanofi, Montpellier, France.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Naditch-Brûlé', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420926874']
981,32512380,Continuous Wound Infiltration With Ropivacaine After Mastectomy: A Randomized Controlled Trial.,"BACKGROUND
To evaluate the efficacy of continuous wound infiltration with ropivacaine to reduce acute postoperative pain in patients undergoing mastectomy for carcinoma of the breast.
MATERIALS AND METHODS
A randomized, double-blind, placebo-controlled trial was conducted. One hundred fifty patients were randomly assigned to receive continuous ropivacaine (0.2%) (group A, n = 74) or saline solution (0.9%) (group B, n = 76) at 10 mL/h for 48 h through a multilumen catheter placed during the surgical procedure. Postoperative morphine consumption and visual analog scale (VAS) pain scores were recorded. A quality of life score (Quality of life questionnaire Core 30) and a VAS score were obtained at 1, 3, and 6 mo after surgery.
RESULTS
The difference in mean morphine consumption between the two groups was close to significance during the first 48 h postsurgery (P = 0.056; 10.8 ± 16.5 versus 4.8 ± 10.4 mg). At day 1, patients in the ropivacaine-infusion group had lower morphine consumption than the control group (P = 0.0026). The link between local ropivacaine infiltration and a decrease in mean postoperative VAS scores reached significance for the first 24 h postsurgery (P = 0.039). No significant difference was found between the two arms for VAS pain scores (P = 0.36) or for quality of life (overall QLQ-C30 score, P = 0.09) at 1, 3, or 6 mo.
CONCLUSIONS
Continuous wound infiltration with ropivacaine is efficacious in reducing postoperative pain. Quality of life and chronic pain at 1, 3, and 6 mo were not improved by ropivacaine wound infiltration.",2020,"No significant difference was found between the two arms for VAS pain scores (P = 0.36) or for quality of life (overall QLQ-C30 score, P = 0.09) at 1, 3, or 6 mo.
","['patients undergoing mastectomy for carcinoma of the breast', 'One hundred fifty patients']","['ropivacaine-infusion', 'ropivacaine', 'Mastectomy', 'saline solution', 'continuous ropivacaine', 'Ropivacaine', 'placebo']","['Quality of life and chronic pain', 'acute postoperative pain', 'A quality of life score (Quality of life questionnaire Core 30) and a VAS score', 'postoperative pain', 'mean morphine consumption', 'mean postoperative VAS scores', 'morphine consumption', 'quality of life (overall QLQ-C30 score', 'VAS pain scores', 'Postoperative morphine consumption and visual analog scale (VAS) pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0238033', 'cui_str': 'Carcinoma of male breast'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",150.0,0.396965,"No significant difference was found between the two arms for VAS pain scores (P = 0.36) or for quality of life (overall QLQ-C30 score, P = 0.09) at 1, 3, or 6 mo.
","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Beguinot', 'Affiliation': ""Département d'oncologie, Médipôle Hôpital Mutualiste Lyon Villeurbanne, Villeurbanne, France.""}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Monrigal', 'Affiliation': 'Département de Chirurgie Sénologique, Montpellier Institut du Sein, Clinique Clémentville, Montpellier, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Kwiatkowski', 'Affiliation': 'Délégation Recherche Clinique & Innovation, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.'}, {'ForeName': 'Angeline', 'Initials': 'A', 'LastName': 'Ginzac', 'Affiliation': ""Délégation Recherche Clinique & Innovation, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France; Université Clermont Auvergne, Centre Jean Perrin, INSERM, U1240 Imagerie Moléculaire et Stratégies Théranostiques, Clermont-Ferrand, France; Centre d'Investigation Clinique, UMR501, Clermont-Ferrand, France. Electronic address: Angeline.ginzac@clermont.unicancer.fr.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Joly', 'Affiliation': ""Département d'anesthésie-réanimation, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Gayraud', 'Affiliation': ""Département d'anesthésie-réanimation, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Le Bouedec', 'Affiliation': 'Département de Chirurgie Oncologique, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gimbergues', 'Affiliation': 'Département de Chirurgie Oncologique, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.006']
982,32512477,"Effect of a maximal exercise test on serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium in athletes.","AIM
This study aims to determine the changes induced by a maximal exercise test until exhaustion on the serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr) in athletes (AG) and sedentary students (SG).
METHODS
Fifty subjects participated in the study divided into two groups. In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students. Both groups performed an exercise test until exhaustion, starting at 8 or 10 km/h respectively, and increasing the speed at 1 km/h every 400 m. Serum and urine samples were obtained from all participants before and after the test.
RESULTS
Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG. Comparing the pre and post-test values, corrected or non-corrected for hemoconcentration in serum and for creatinine in urine, AG showed a decrease in serum Mg (p < 0.05), in serum P (p < 0.01) and in urinary Sr (p < 0.01) while an increase was observed in urinary P (p < 0.05) and in urinary Rb (p < 0.05).
CONCLUSIONS
It can be concluded that a treadmill test until exhaustion leads to changes in serum and urinary concentrations of minerals in both AG and SG males. This may reflect an adaptive response of the body to overcome the physical stress and, in some cases, to avoid loss of these elements.",2020,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","['athletes', 'athletes (AG) and sedentary students (SG', 'In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students', 'Fifty subjects participated in the study divided into two groups']",['maximal exercise test'],"['urinary Rb', 'serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr', 'urinary Sr', 'serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0035930', 'cui_str': 'Rubidium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0038467', 'cui_str': 'Strontium'}]",25.0,0.0207851,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: diegomun@unex.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Grijota', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: fgrijota@gmail.com.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: jsiquier@alumnos.unex.es.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro-Román', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: vtororom@alumnos.unex.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: ignbs.1991@gmail.com.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: mmaynar@unex.es.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126572']
983,32518499,Risk factors for mortality among Tanzanian infants and children.,"Background
During the era of the Millennium Development Goals, under 5 mortality rates decreased significantly worldwide; however, reductions were not equally distributed. Children in sub-Saharan Africa still account for more than 50% of the world's annual childhood deaths among children under 5 years of age. Understanding upstream risk factors for mortality among children may reduce the large burden of childhood mortality in sub-Saharan Africa. Our objective was to identify risk factors for mortality among infants and children in Tanzania.
Methods
We conducted a secondary analysis of data pooled from two randomized-controlled micronutrient supplementation trials. A total of 4787 infants were enrolled in the two trials ( n = 2387 HIV-exposed and n = 2400 HIV-unexposed). Predictors of mortality were assessed using unadjusted and adjusted hazard ratios (aHRs).
Results
There were 307 total deaths, 262 (11%) among children who were HIV-exposed and 45 (2%) among children who were HIV-unexposed ( P < 0.001). The most common cause of death was respiratory diseases ( n = 109, 35.5%). Causes of death did not significantly differ between HIV-exposed and HIV-unexposed children. In adjusted regression analyses, children with birth weight <2500 g (aHR 1.75, 95% CI 1.21-2.54), Apgar score of ≤7 at 5 min (aHR 2.16, 95% CI 1.29-3.62), or who were HIV-exposed but not infected (aHR 3.35, 95% CI 2.12-5.28) or HIV-infected (aHR 27.56, 95% CI 17.43-43.58) had greater risk of mortality.
Conclusions
Infection with HIV, low birthweight, or low Apgar scores were associated with higher mortality risk. Early identification and modification of determinants of mortality among infants and children may be the first step to reducing such deaths.",2020,Causes of death did not significantly differ between HIV-exposed and HIV-unexposed children.,"['Tanzanian infants and children', 'infants and children', 'A total of 4787 infants were enrolled in the two trials ( n = 2387', 'infants and children in Tanzania']",[],"['Apgar score', 'risk of mortality', 'Causes of death']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]",[],"[{'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}]",4787.0,0.364443,Causes of death did not significantly differ between HIV-exposed and HIV-unexposed children.,"[{'ForeName': 'Rodrick R', 'Initials': 'RR', 'LastName': 'Kisenge', 'Affiliation': 'Department of Paediatrics and Child Health, Muhimbili University of Health and Allied Sciences, P.O. Box 65001, Dar es Salaam, Tanzania.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rees', 'Affiliation': ""Division of Emergency Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA USA.""}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Lauer', 'Affiliation': ""Clinical Research Centre, Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Boston, MA USA.""}, {'ForeName': 'Enju', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': ""Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, MA USA.""}, {'ForeName': 'Wafaie W', 'Initials': 'WW', 'LastName': 'Fawzi', 'Affiliation': 'Department of Global Health and Population, Harvard School of Public Health, Boston, MA USA.'}, {'ForeName': 'Karim P', 'Initials': 'KP', 'LastName': 'Manji', 'Affiliation': 'Department of Paediatrics and Child Health, Muhimbili University of Health and Allied Sciences, P.O. Box 65001, Dar es Salaam, Tanzania.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': 'Department of Paediatrics and Child Health, Muhimbili University of Health and Allied Sciences, P.O. Box 65001, Dar es Salaam, Tanzania.'}]",Tropical medicine and health,['10.1186/s41182-020-00233-8']
984,32532280,Monetary incentives and peer referral in promoting digital network-based secondary distribution of HIV self-testing among men who have sex with men in China: study protocol for a three-arm randomized controlled trial.,"BACKGROUND
Human immunodeficiency virus (HIV) testing is a crucial strategy for HIV prevention. HIV testing rates remain low among men who have sex with men (MSM) in China. Digital network-based secondary distribution is considered as an effective model to enhance HIV self-testing (HIVST) among key populations. Digital platforms provide opportunities for testers to apply for HIVST kits by themselves, and secondary distribution allows them to apply for multiple kits to deliver to their sexual partners or members within their social network. We describe a three-arm randomized controlled trial to examine the effect of monetary incentives and peer referral in promoting digital network-based secondary distribution of HIVST among MSM in China.
METHODS
Three hundred MSM in China will be enrolled through a digital platform for data collection. The eligibility criteria include being biological male, 18 years of age or over, ever having had sex with another man, being able to apply for kits via the online platform, and being willing to provide personal telephone number for follow-up. Eligible participants will be randomly allocated into one of the three arms: standard secondary distribution arm, secondary distribution with monetary incentives arm, and secondary distribution with monetary incentives plus peer referral arm. Participants (defined as ""index"") will distribute actual HIV self-test kits to members within their social network (defined as ""alter"") or share referral links to encourage alters to apply HIV self-test kits by themselves. All index participants will be requested to complete a baseline survey and a 3-month follow-up survey. Both indexes and alters will complete a survey upon returning the results by taking a photo of the used kits with the unique identification number.
DISCUSSION
HIV testing rates remain suboptimal among MSM in China. Innovative interventions are needed to further expand the uptake of HIV testing among key populations. The findings of the trial can provide scientific evidence and experience on promoting secondary distribution of HIVST to reach key populations who have not yet been covered by existing testing services.
TRIAL REGISTRATION
The study was registered in the Chinese Clinical Trial Registry (ChiCTR1900025433) on 26, August 2019, http://www.chictr.org.cn/showproj.aspx?proj=42001. Prospectively registered.",2020,"We describe a three-arm randomized controlled trial to examine the effect of monetary incentives and peer referral in promoting digital network-based secondary distribution of HIVST among MSM in China.
","['men who have sex with men (MSM) in China', 'men who have sex with men in China', 'The eligibility criteria include being biological male, 18\u2009years of age or over, ever having had sex with another man, being able to apply for kits via the online platform, and being willing to provide personal telephone number for follow-up', 'Eligible participants']","['standard secondary distribution arm, secondary distribution with monetary incentives arm, and secondary distribution with monetary incentives plus peer referral arm', 'monetary incentives and peer referral']",[],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]",[],,0.157662,"We describe a three-arm randomized controlled trial to examine the effect of monetary incentives and peer referral in promoting digital network-based secondary distribution of HIVST among MSM in China.
","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Zhuhai Xutong Voluntary Services Center, Zhuhai, China.'}, {'ForeName': 'Shanzi', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Wencan', 'Initials': 'W', 'LastName': 'Dai', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Guangquan', 'Initials': 'G', 'LastName': 'Shen', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Yongjie', 'Initials': 'Y', 'LastName': 'Sha', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China. weiming_tang@med.unc.edu.'}]",BMC public health,['10.1186/s12889-020-09048-y']
985,32538466,"Limited effectiveness of four oral antifungal drugs (fluconazole, griseofulvin, itraconazole and terbinafine) in the current epidemic of altered dermatophytosis in India: results of a randomized pragmatic trial.","BACKGROUND
Dermatophytic infections have undergone unprecedented changes in India in the recent past. Clinical trials to find out the effectiveness of the four main oral antifungal drugs are lacking.
OBJECTIVES
We tested the effectiveness of oral fluconazole, griseofulvin, itraconazole and terbinafine in chronic and chronic relapsing tinea corporis, tinea cruris and tinea faciei in an investigator-initiated, randomized, pragmatic trial.
METHODS
Two hundred patients with microscopy-confirmed tinea were allocated to four groups (50 patients in each group): fluconazole 5 mg kg -1 per day, griseofulvin 10 mg kg -1 per day, itraconazole 5 mg kg -1 per day and terbinafine 7·5 mg kg -1 per day. Allocation was performed by concealed block randomization and the patients were treated for 8 weeks or until cure. Effectiveness was calculated based on intention-to-treat analysis. The trial was registered with the Clinical Trials Registry India (CTRI/2017/04/008281).
RESULTS
At 4 weeks, all drugs were similarly ineffective, with cure rates being 8% or less (P = 0·42). At 8 weeks, the numbers of patients cured were as follows: fluconazole 21 (42%), griseofulvin seven (14%), itraconazole 33 (66%) and terbinafine 14 (28%) (P < 0·001). Itraconazole was superior to fluconazole, griseofulvin and terbinafine (adjusted P ≤ 0·048). Relapse rates after 4 and 8 weeks of cure with the four treatments were not different (P ≥ 0·42). Numbers needed to treat (vs. griseofulvin), calculated on the basis of cure rates at 8 weeks, were as follows: fluconazole 4, itraconazole 2 and terbinafine 8.
CONCLUSIONS
The results show limited effectiveness of all four antifungal drugs. In view of cure rates and the number needed to treat, itraconazole is the most effective drug, followed by fluconazole (daily), terbinafine and then griseofulvin, in chronic and chronic relapsing dermatophytosis in India. What is already known about this topic? Oral antifungal drugs are considered to have a high cure rate in tinea corporis, tinea cruris and tinea faciei. Unprecedented changes have been noticed in the last few years in India in the morphology, course and treatment responsiveness of tinea; however, data about the effectiveness of oral antifungals are lacking. What does this study add? Our results show limited effectiveness of four oral antifungal drugs (fluconazole, griseofulvin, itraconazole and terbinafine) in the current epidemic of altered dermatophytosis in India. Among the four drugs tested, oral itraconazole is the most effective. Linked Comment: Elewski. Br J Dermatol 2020; 183:798-799.",2020,Relapse rates after 4 and 8 weeks of cure with the four treatments were not different (P ≥ 0·42).,"['altered dermatophytosis in India', 'Two hundred patients with microscopy-confirmed tinea']","['fluconazole, griseofulvin, itraconazole and terbinafine', 'fluconazole 5 mg kg -1 per day, griseofulvin 10 mg kg -1 per day, itraconazole', 'fluconazole', 'terbinafine', 'itraconazole', 'griseofulvin', 'Itraconazole', 'oral antifungal drugs (fluconazole, griseofulvin, itraconazole and terbinafine', 'fluconazole, griseofulvin and terbinafine', 'terbinafine 7·5']","['cure rates', 'Effectiveness', 'Relapse rates']","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011636', 'cui_str': 'Dermatophytosis'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0040247', 'cui_str': 'Tinea infection'}]","[{'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0018242', 'cui_str': 'Griseofulvin'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0076110', 'cui_str': 'terbinafine'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003308', 'cui_str': 'Antifungal-containing product'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",200.0,0.0387624,Relapse rates after 4 and 8 weeks of cure with the four treatments were not different (P ≥ 0·42).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Chandra', 'Affiliation': 'Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'V N', 'Initials': 'VN', 'LastName': 'Anchan', 'Affiliation': 'Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Verma', 'Affiliation': 'Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Tilak', 'Affiliation': 'Department of Microbiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}]",The British journal of dermatology,['10.1111/bjd.19146']
986,32493372,Comparison of intrathecal morphine with continuous patient-controlled epidural anesthesia versus intrathecal morphine alone for post-cesarean section analgesia: a randomized controlled trial.,"BACKGROUND
Several neuraxial techniques have demonstrated effective post-cesarean section analgesia. According to previous reports, it is likely that patient-controlled epidural analgesia (PCEA) without opioids is inferior to intrathecal morphine (IM) alone for post-cesarean section analgesia. However, little is known whether adding PCEA to IM is effective or not. The aim of this study was to compare post-cesarean section analgesia between IM with PCEA and IM alone.
METHODS
Fifty patients undergoing elective cesarean section were enrolled in this prospective randomized study. Patients were randomized to one of two groups: IM group and IM + PCEA group. All patients received spinal anesthesia with 12 mg of 0.5% hyperbaric bupivacaine, 10 μg of fentanyl, and 150 μg of morphine. Patients in IM + PCEA group received epidural catheterization through Th11-12 or Th12-L1 before spinal anesthesia and PCEA (basal 0.167% levobupivacaine infusion rate of 6 mL/h, bolus dose of 3 mL in lockout interval of 30 min) was commenced at the end of surgery. A numerical rating scale (NRS) at rest and on movement at 4,8,12,24,48 h after the intrathecal administration of morphine were recorded. In addition, we recorded the incidence of delayed ambulation and the number of patients who requested rescue analgesics. We examined NRS using Bonferroni's multiple comparison test following repeated measures analysis of variance; p < 0.05 was considered as statistically significant.
RESULTS
Twenty-three patients in each group were finally analyzed. Mean NRS at rest was significantly higher in IM group than in IM + PCEA group at 4 (2.7 vs 0.6), 8 (2.2 vs 0.6), and 12 h (2.5 vs 0.7), and NRS during mobilization was significantly higher in IM group than in IM + PCEA group at 4 (4.9 vs 1.5), 8 (4.8 vs 1.9), 12 (4.9 vs 2), and 24 h (5.7 vs 3.5). The number of patients who required rescue analgesics during the first 24 h was significantly higher in IM group compared to IM + PCEA group. No significant difference was observed between the groups in incidence of delayed ambulation.
CONCLUSIONS
The combined use of PCEA with IM provided better post-cesarean section analgesia compared to IM alone.
TRIAL REGISTRATION
UMIN-CTR (Registration No. UMIN000032475). Registered 6 May 2018 - Retrospectively registered.",2020,The number of patients who required rescue analgesics during the first 24 h was significantly higher in IM group compared to IM + PCEA group.,"['Fifty patients undergoing elective cesarean section', 'post-cesarean section analgesia']","['PCEA and IM alone', 'PCEA', 'IM group and IM\u2009+\u2009PCEA', 'morphine', 'intrathecal morphine alone', 'epidural catheterization through Th11-12 or Th12-L1 before spinal anesthesia and PCEA (basal 0.167% levobupivacaine', 'intrathecal morphine', 'IM\u2009+\u2009PCEA', 'spinal anesthesia with 12\u2009mg of 0.5% hyperbaric bupivacaine']","['numerical rating scale (NRS', 'Mean NRS at rest', 'incidence of delayed ambulation', 'NRS during mobilization', 'delayed ambulation and the number of patients who requested rescue analgesics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",50.0,0.0935582,The number of patients who required rescue analgesics during the first 24 h was significantly higher in IM group compared to IM + PCEA group.,"[{'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Sato', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan. iwasakih@asahikawa-med.ac.jp.'}, {'ForeName': 'Sarah Kyuragi', 'Initials': 'SK', 'LastName': 'Luthe', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Iida', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Kanda', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan.'}]",BMC anesthesiology,['10.1186/s12871-020-01050-6']
987,32193166,Add a comment … how fitspiration and body positive captions attached to social media images influence the mood and body esteem of young female Instagram users.,"Social media content can negatively influence body esteem in young women by reinforcing beliefs that to be considered attractive, people must look a certain way. The current study examines how text associated with attractive social media images impacts on female users' mood and feelings about their own body. Female participants (N = 109) aged between 18 and 25 years were randomly allocated to one of three conditions in which they viewed the same fitspiration-style images from Instagram. However, the captions associated with each image were experimentally manipulated to reflect either a fitspiration, body positive, or neutral theme. Images associated with fitspiration captions encouraging observers to improve their personal fitness led to increased negative mood. When body-positive captions encouraging the self-acceptance of appearance or highlighting the unrealistic nature of social media content were viewed with the same images, no increase in negative affect was observed, and participants reported greater body esteem post exposure. The findings provide partial support for the idea that body positive comments accompanying images on Instagram may have some protective value for female body esteem. Captions may play an important part in observers' reactions to social media images, beyond the influence of the images alone.",2020,"Captions may play an important part in observers' reactions to social media images, beyond the influence of the images alone.","['Female participants (N = 109) aged between 18 and 25 years', 'young female Instagram users', ""female users' mood and feelings about their own body"", 'young women']",[],"['body esteem', 'mood and body esteem']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0026516', 'cui_str': 'Mood'}]",109.0,0.0163805,"Captions may play an important part in observers' reactions to social media images, beyond the influence of the images alone.","[{'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Davies', 'Affiliation': 'Department of Psychology, King Henry Building, University of Portsmouth, Portsmouth, PO1 2DY. United Kingdom. Electronic address: Bryony.Davies@port.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Turner', 'Affiliation': 'Department of Psychology, King Henry Building, University of Portsmouth, Portsmouth, PO1 2DY. United Kingdom. Electronic address: Mark.Turner@port.ac.uk.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Udell', 'Affiliation': 'Department of Psychology, King Henry Building, University of Portsmouth, Portsmouth, PO1 2DY. United Kingdom. Electronic address: Julie.Udell@port.ac.uk.'}]",Body image,['10.1016/j.bodyim.2020.02.009']
988,31409915,Add-on ezetimibe treatment to low-dose statins vs medium-intensity statin monotherapy in coronary artery disease patients with poorly controlled dyslipidemia.,"Although ezetimibe has potential value as an add-on therapy to statins, it is not established whether the addition of ezetimibe to statin therapy is more effective than double-dose statin monotherapy. We conducted a crossover design study. Twenty-one coronary artery disease (CAD) patients whose lipid profiles had not achieved Japanese guideline recommendations (JAS 2017), despite receiving low-dose statin therapy, were divided into two groups. Group A received ezetimibe 10 mg in addition to the baseline dose of statin for the first 3 months and was then switched to monotherapy with a double dose of statin for the next 3 months. Group B first received a double dose of statin for 3 months and was then switched to ezetimibe 10 mg in addition to a baseline dose of statin for the next 3 months. Compared with the baseline, double-dose statin therapy reduced low-density lipoprotein (LDL)-cholesterol (from 118 ± 22 to 104 ± 15 mg/dL, P < 0.05) and malondialdehyde-modified LDL (MDA-LDL) (from 142 ± 35 to 126 ± 24 U/L, P < 0.05) but did not lower high-sensitivity C-reactive protein (hsCRP) (3.02 ± 0.47 and 2.98 ± 0.41 log [ng/ml]). The addition of ezetimibe to a baseline dose of statin further reduced LDL-cholesterol (to 89 ± 15, P < 0.0001) and MDA-LDL (to 114 ± 22 U/L, P < 0.001) and reduced hsCRP (to 2.78 ± 0.38 log (ng/ml), P < 0.05). The changes in the levels of MDA-LDL (R = 0.548, P = 0.010) and hsCRP (R = 0.473, P < 0.05) were significantly correlated with the change in the LDL-cholesterol level after the addition of ezetimibe. Add-on ezetimibe treatment appears superior to double-dose statin therapy in CAD patients with poorly controlled dyslipidemia in terms of reductions in LDL-cholesterol level, lipid peroxidation, and inflammation.",2019,"The changes in the levels of MDA-LDL (R = 0.548, P = 0.010) and hsCRP (R = 0.473, P < 0.05) were significantly correlated with the change in the LDL-cholesterol level after the addition of ezetimibe.","['Twenty-one coronary artery disease (CAD) patients whose lipid profiles had not achieved Japanese guideline recommendations (JAS 2017), despite receiving low-dose statin therapy', 'coronary artery disease patients with poorly controlled dyslipidemia', 'CAD patients with poorly controlled dyslipidemia']","['ezetimibe 10\u2009mg in addition to the baseline dose of statin', 'ezetimibe', 'statins vs medium-intensity statin monotherapy', 'ezetimibe 10\u2009mg in addition to a baseline dose of statin']","['reduced hsCRP', 'levels of MDA-LDL', 'malondialdehyde-modified LDL (MDA-LDL', 'high-sensitivity C-reactive protein (hsCRP', 'low-density lipoprotein (LDL)-cholesterol', 'LDL-cholesterol', 'hsCRP', 'MDA-LDL', 'LDL-cholesterol level, lipid peroxidation, and inflammation', 'LDL-cholesterol level']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}]","[{'cui': 'C1593702', 'cui_str': 'ezetimibe 10 MG [Zetia]'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",21.0,0.154215,"The changes in the levels of MDA-LDL (R = 0.548, P = 0.010) and hsCRP (R = 0.473, P < 0.05) were significantly correlated with the change in the LDL-cholesterol level after the addition of ezetimibe.","[{'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan. masakuma@dokkyomed.ac.jp.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan.'}, {'ForeName': 'Ryouta', 'Initials': 'R', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Yazawa', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan.'}, {'ForeName': 'Taiki', 'Initials': 'T', 'LastName': 'Masuyama', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Hirose', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan.'}, {'ForeName': 'Ryutaro', 'Initials': 'R', 'LastName': 'Waku', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Hasumi', 'Affiliation': 'Department of Internal Medicine, Nishiyamado-Keiwa Hospital, 3247-1 Kounosu, Naka, Ibaraki, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Numao', 'Affiliation': 'Department of Internal Medicine, Mori Hospital, 674 Imaichi, Nikkou, Tochigi, Japan.'}, {'ForeName': 'Shichiro', 'Initials': 'S', 'LastName': 'Abe', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan.'}, {'ForeName': 'Teruo', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0308-5']
989,32499125,Effect of Acupuncture in Patients With Irritable Bowel Syndrome: A Randomized Controlled Trial.,"OBJECTIVE
To evaluate the effect and safety of acupuncture for the treatment of irritable bowel syndrome (IBS) through comparisons with those of polyethylene glycol (PEG) 4000 and pinaverium bromide.
PATIENTS AND METHODS
This multicenter randomized controlled trial was conducted at 7 hospitals in China and enrolled participants who met the Rome III diagnostic criteria for IBS between May 3, 2015, and June 29, 2018. Participants were first stratified into constipation-predominant or diarrhea-predominant IBS group. Participants in each group were randomly assigned in a 2:1 ratio to receive acupuncture (18 sessions) or PEG 4000 (20 g/d, for IBS-C)/pinaverium bromide (150 mg/d, for IBS-D) over a 6-week period, followed by a 12-week follow-up. The primary outcome was change in total IBS-Symptom Severity Score from baseline to week 6.
RESULTS
Of 531 patients with IBS who were randomized, 519 (344 in the acupuncture group and 175 in the PEG 4000/ pinaverium bromide group) were included in the full analysis set. From baseline to 6 weeks, the total IBS-Symptom Severity Score decreased by 123.51 (95% CI, 116.61 to 130.42) in the acupuncture group and 94.73 (95% CI, 85.03 to 104.43) in the PEG 4000/pinaverium bromide group. The between-group difference was 28.78 (95% CI, 16.84 to 40.72; P<.001). No participant experienced severe adverse effects.
CONCLUSION
Acupuncture may be more effective than PEG 4000 or pinaverium bromide for the treatment of IBS, with effects lasting up to 12 weeks.
TRIAL REGISTRATION
Chinese Clinical Trials Register, ChiCTR-IOR-15006259.",2020,"From baseline to 6 weeks, the total IBS-Symptom Severity Score decreased by 123.51 (95% CI, 116.61 to 130.42) in the acupuncture group and 94.73 (95% CI, 85.03 to 104.43) in the PEG 4000/pinaverium bromide group.","['irritable bowel syndrome (IBS', 'Patients With Irritable Bowel Syndrome', 'Participants were first stratified into constipation-predominant or diarrhea-predominant IBS group', '7 hospitals in China and enrolled participants who met the Rome III diagnostic criteria for IBS between May 3, 2015, and June 29, 2018', '531 patients with IBS who were randomized, 519 (344 in the acupuncture group and 175 in the PEG 4000/ pinaverium bromide group) were included in the full analysis set']","['acupuncture', 'polyethylene glycol (PEG) 4000 and pinaverium bromide', 'Acupuncture', 'acupuncture (18 sessions) or PEG 4000 (20 g/d, for IBS-C)/pinaverium bromide']","['total IBS-Symptom Severity Score', 'severe adverse effects']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0137073', 'cui_str': 'Pinaverium bromide'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0137073', 'cui_str': 'Pinaverium bromide'}, {'cui': 'C0032479', 'cui_str': 'polyethylene glycol 4000'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0006222', 'cui_str': 'bromides'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",531.0,0.308207,"From baseline to 6 weeks, the total IBS-Symptom Severity Score decreased by 123.51 (95% CI, 116.61 to 130.42) in the acupuncture group and 94.73 (95% CI, 85.03 to 104.43) in the PEG 4000/pinaverium bromide group.","[{'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Pei', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Geng', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Shuyang Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Shuyang Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Rongrong', 'Initials': 'R', 'LastName': 'Shen', 'Affiliation': 'Nantong Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Nantong Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': 'Wuxi Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'Wuxi Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Nanjing Hospital of Chinese Medicine affiliated to Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Affiliated Hospital of Jiangsu University, Zhenjiang, China.'}, {'ForeName': 'Yanye', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Affiliated Hospital of Jiangsu University, Zhenjiang, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'Affiliated Hospital of Jiangsu University, Zhenjiang, China; Kunshan Hospital of Traditional Chinese Medicine, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Shengjie', 'Initials': 'S', 'LastName': 'Weng', 'Affiliation': 'Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Ju', 'Affiliation': 'Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Nanjing University of Chinese Medicine, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China. Electronic address: shenghong999@163.com.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Nanjing, China. Electronic address: 377201634@qq.com.'}]",Mayo Clinic proceedings,['10.1016/j.mayocp.2020.01.042']
990,32505019,"Indentation marks, skin temperature and comfort of two cervical collars: A single-blinded randomized controlled trial in healthy volunteers.","BACKGROUND
Collar-related pressure ulcers (CRPU) are a problem in trauma patients with a suspicion of cervical cord injury patients. Indentation marks (IM), skin temperature (T sk ) and comfort could play a role in the development of CRPU. Two comparable cervical collars are the Stifneck® and Philadelphia®. However, the differences between them remain unclear.
AIM
To determine and compare occurrence and severity of IM, T sk and comfort of the Stifneck® and Philadelphia® in immobilized healthy adults.
METHODS
This single-blinded randomized controlled trial compared two groups of immobilized participants in supine position for 20 min.
RESULTS
All participants (n = 60) generated IM in at least one location in the observed area. Total occurrence was higher in the Stifneck®-group (n = 95 versus n = 69; p = .002). T sk increased significantly with 1.0 °C in the Stifneck®-group and 1.3 °C in the Philadelphia®-group (p = .024). Comfort was rated 3 on a scale of 5 (p = .506).
CONCLUSION
The occurrence of IM in both groups was high. In comparison to the Stifneck®, fewer and less severe IM were observed from the Philadelphia®. The T sk increased significantly with both collars; however, no clinical difference in increase of T sk between them was found. The results emphasize the need for a better design of cervical collars regarding CRPU.",2020,Total occurrence was higher in the Stifneck®-group,"['immobilized healthy adults', 'trauma patients with a suspicion of cervical cord injury patients', 'healthy volunteers', 'participants in supine position for 20\xa0min']","['immobilized', 'Collar-related pressure ulcers (CRPU']","['Indentation marks (IM), skin temperature (T sk ) and comfort', 'T sk', 'severe IM', 'Total occurrence', 'Indentation marks, skin temperature and comfort of two cervical collars']","[{'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0457846', 'cui_str': 'Segment of cervical spinal cord'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}]","[{'cui': 'C0332467', 'cui_str': 'Indentation'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}]",,0.152707,Total occurrence was higher in the Stifneck®-group,"[{'ForeName': 'J P L', 'Initials': 'JPL', 'LastName': 'Leenen', 'Affiliation': 'Department of Surgery, Isala, Dr. van Heesweg 2, 8025 AB Zwolle, The Netherlands. Electronic address: j.p.l.leenen@isala.nl.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Ham', 'Affiliation': 'Emergency Department, University Medical Center Utrecht, University of Applied Science, Institute of Nursing Studies, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands. Electronic address: w.h.ham@umcutrecht.nl.'}, {'ForeName': 'L P H', 'Initials': 'LPH', 'LastName': 'Leenen', 'Affiliation': 'Department of Traumatology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands. Electronic address: l.p.h.leenen@umcutrecht.nl.'}]",International emergency nursing,['10.1016/j.ienj.2020.100878']
991,32507436,"Efficacy and safety of Euiiyin-tang in Korean women with obesity: A randomized, double-blind, placebo-controlled, multicenter trial.","BACKGROUND
Obesity is a global health problem and its incidence is on the rise. Euiiyin-tang is an herbal medicinal formula that is often used in the clinical treatment of obesity. The purpose of the present study was to evaluate the efficacy and safety of Euiiyin-tang in obesity treatment.
METHODS
A randomized, double-blind, placebo-controlled, multicenter trial was conducted. Participants with obesity were randomly assigned to receive Euiiyin-tang or placebo 3 times daily for 12-weeks. The primary outcome was weight reduction between the baseline and 12 weeks. The secondary outcomes included the rate of weight loss compared to baseline, and changes in body mass index, lipid profiles, and questionnaires related to the quality of life and diet. Safety factors, such as vital signs and laboratory parameters, were also measured.
RESULTS
A total of 149 participants were randomly distributed to either the Euiiyin-tang group (n = 76) or the placebo group (n = 73). Weight reduction in the Euiiyin-tang group was significantly greater than that in the placebo group (2.50 kg in the Euiiyin-tang group vs. 0.82 kg in the placebo group). The participant response rates of ≥3% weight loss compared to baseline was 36.8 % in the Euiiyin-tang group and 17.8 % in the placebo group. Body mass index, waist circumference, and hip circumference showed a greater change in the Euiiyin-tang group than in the placebo group (1.00, 3.23, and 2.00 in the Euiiyin-tang group vs. 0.33, 1.96, and 0.86 in the placebo group). Questionnaires, lipid profiles, and safety factors did not show significant differences between groups.
CONCLUSION
The results of this study suggest that Euiiyin-tang has beneficial effects on weight loss.
TRIAL REGISTRATION
Clinicaltrials.gov NCT01724099.",2020,"Body mass index, waist circumference, and hip circumference showed a greater change in the Euiiyin-tang group than in the placebo group (1.00, 3.23, and 2.00 in the Euiiyin-tang group vs. 0.33, 1.96, and 0.86 in the placebo group).","['Korean women with obesity', 'Participants with obesity', 'A total of 149 participants']","['Euiiyin-tang or placebo', 'Euiiyin-tang', 'placebo']","['response rates of ≥3% weight loss', 'Efficacy and safety', 'Body mass index, waist circumference, and hip circumference', 'efficacy and safety', 'weight loss', 'rate of weight loss compared to baseline, and changes in body mass index, lipid profiles, and questionnaires related to the quality of life and diet', 'Weight reduction', 'weight reduction', 'Questionnaires, lipid profiles, and safety factors']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191071', 'cui_str': '149'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",149.0,0.597809,"Body mass index, waist circumference, and hip circumference showed a greater change in the Euiiyin-tang group than in the placebo group (1.00, 3.23, and 2.00 in the Euiiyin-tang group vs. 0.33, 1.96, and 0.86 in the placebo group).","[{'ForeName': 'Chunhoo', 'Initials': 'C', 'LastName': 'Cheon', 'Affiliation': 'Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, Kyungheedae-ro 26, Dongdaemun-gu, Seoul 02447, Republic of Korea. Electronic address: hreedom35@gmail.com.'}, {'ForeName': 'Yun-Kyung', 'Initials': 'YK', 'LastName': 'Song', 'Affiliation': 'Department of Korean Medicine Rehabilitation, College of Korean Medicine, Gachon University, 1342 Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea. Electronic address: lyricsong@naver.com.'}, {'ForeName': 'Seong-Gyu', 'Initials': 'SG', 'LastName': 'Ko', 'Affiliation': 'Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, Kyungheedae-ro 26, Dongdaemun-gu, Seoul 02447, Republic of Korea. Electronic address: epiko@khu.ac.kr.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102423']
992,32507439,"Effects of garlic powder supplementation on insulin resistance, oxidative stress, and body composition in patients with non-alcoholic fatty liver disease: A randomized controlled clinical trial.","BACKGROUND
Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. Insulin resistance, oxidative stress, and obesity are major contributors to NAFLD pathogenesis. The effects of garlic powder supplementation on these risk factors in patients with NAFLD was investigated.
METHODS
In this 12-wk, randomized controlled clinical trial, ninety patients with NAFLD were randomly assigned to two groups. The treatment group received four tablets of garlic (each coated tablet contained 400 mg garlic powder) daily and the control group received four tablets of placebo (each coated tablet contained 400 mg starch).
RESULTS
A significant decrease was seen in the treatment group compared to the control group in waist circumference (P = 0.001), body fat percent (P < 0.001), serum concentration of fasting blood sugar (P = 0.01), insulin (P < 0.001), homeostatic model assessment for insulin resistance (P < 0.001), and malondialdehyde (P < 0.001), as well as significant increase in skeletal muscle mass (P = 0.002), serum concentration of superoxide dismutase (P < 0.001), and total antioxidant capacity (P < 0.001).
CONCLUSION
Garlic powder supplementation improved risk factors of NAFLD. Further studies are needed to determine the effects of garlic on hepatic features in patients with NAFLD. The study protocol was registered at Iranian clinical trials website under code IRCT20170206032417N4.",2020,"A significant decrease was seen in the treatment group compared to the control group in waist circumference (P = 0.001), body fat percent (P < 0.001), serum concentration of fasting blood sugar (P = 0.01), insulin (P < 0.001), homeostatic model assessment for insulin resistance (P < 0.001), and malondialdehyde (P < 0.001), as well as significant increase in skeletal muscle mass (P = 0.002), serum concentration of superoxide dismutase (P < 0.001), and total antioxidant capacity (P < 0.001).
","['patients with NAFLD', 'patients with NAFLD was investigated', 'ninety patients with NAFLD', 'patients with non-alcoholic fatty liver disease']","['placebo', 'Garlic powder supplementation', 'garlic powder supplementation', 'garlic']","['insulin resistance, oxidative stress, and body composition', 'waist circumference', 'risk factors of NAFLD', 'serum concentration of superoxide dismutase', 'serum concentration of fasting blood sugar', 'skeletal muscle mass', 'homeostatic model assessment for insulin resistance', 'total antioxidant capacity', 'Insulin resistance, oxidative stress, and obesity', 'body fat percent']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1119842', 'cui_str': 'GARLIC POWDER'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0331590', 'cui_str': 'Allium ameloprasum'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",90.0,0.430577,"A significant decrease was seen in the treatment group compared to the control group in waist circumference (P = 0.001), body fat percent (P < 0.001), serum concentration of fasting blood sugar (P = 0.01), insulin (P < 0.001), homeostatic model assessment for insulin resistance (P < 0.001), and malondialdehyde (P < 0.001), as well as significant increase in skeletal muscle mass (P = 0.002), serum concentration of superoxide dismutase (P < 0.001), and total antioxidant capacity (P < 0.001).
","[{'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Sangouni', 'Affiliation': 'Student Research Committee, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohammad Hosseini Azar', 'Affiliation': 'Gastroenterology and Hepatology Subdivision of Internal Medicine, Imam Khomeini Hospital, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alizadeh', 'Affiliation': 'Food and Beverages Safety Research Center, Urmia University of Medical Sciences, Urmia, Iran; Department of Nutrition, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran. Electronic address: alizadeh.m@umsu.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102428']
993,32507443,"Effects of dry needling on pain, pressure pain threshold and psychological distress in patients with mild to moderate hip osteoarthritis: Secondary analysis of a randomized controlled trial.","OBJECTIVE
To determine the changes produced by dry needling in active myofascial trigger points in hip muscles compared to a sham needling on pain intensity, main pain area, pressure pain threshold and psychological distress in patients with hip osteoarthritis.
DESIGN
Secondary analysis of a single-centre, randomized, double-blinded, clinical trial.
INTERVENTION
30 participants with mild to moderate hip osteoarthritis were randomly assigned to DN group (n = 15) or sham DN group (n = 15). DN group received three sessions of penetrating DN, and sham DN group received three sessions of non-penetrating DN in hip muscles.
MAIN OUTCOME MEASURES
Pain intensity (Visual Analogue Scale), main pain area (body chart), pressure pain threshold (algometry), psychological distress (Hospital Anxiety and Depression Scale) and self-reported improvement (Global Rate of Change) were measured before and after treatment.
RESULTS
DN group showed statistically significant improvements with large effect sizes for pain intensity (p < 0.001; E.S: 2.7), pressure pain thresholds (p < 0.05; E.S: 1.3-1.8) and psychological distress (p = 0.002; E.S: 1.5) compared to sham DN group. The DN group described a self-reported improvement categorised as quite a bit, great or very great deal better (n = 12, 80%). No statistically significant differences were found between baseline and postintervention in the sham DN group in any variable (p > 0.05).
CONCLUSIONS
Three sessions of dry needling were more effective than sham dry needling for improving pain intensity, pressure pain threshold and psychological distress in patients with mild to moderate hip osteoarthritis in the short term.",2020,"CONCLUSIONS
Three sessions of dry needling were more effective than sham dry needling for improving pain intensity, pressure pain threshold and psychological distress in patients with mild to moderate hip osteoarthritis in the short term.","['30 participants with mild to moderate hip osteoarthritis', 'patients with hip osteoarthritis', 'patients with mild to moderate hip osteoarthritis']","['penetrating DN, and sham DN group received three sessions of non-penetrating DN in hip muscles', 'dry needling', 'sham DN', 'sham needling']","['Pain intensity (Visual Analogue Scale), main pain area (body chart), pressure pain threshold (algometry), psychological distress (Hospital Anxiety and Depression Scale) and self-reported improvement (Global Rate of Change', 'pain intensity, main pain area, pressure pain threshold and psychological distress', 'pain, pressure pain threshold and psychological distress', 'pain intensity, pressure pain threshold and psychological distress', 'pain intensity', 'pressure pain thresholds', 'psychological distress']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",30.0,0.401098,"CONCLUSIONS
Three sessions of dry needling were more effective than sham dry needling for improving pain intensity, pressure pain threshold and psychological distress in patients with mild to moderate hip osteoarthritis in the short term.","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ceballos-Laita', 'Affiliation': 'Department of Surgery, Ophtalmology and Physiotherapy, University of Valladolid.c/Universidad s/n 42004, Soria, Spain. Electronic address: luis.ceballos@uva.es.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Jiménez-Del-Barrio', 'Affiliation': 'Department of Surgery, Ophtalmology and Physiotherapy, University of Valladolid.c/Universidad s/n 42004, Soria, Spain. Electronic address: Sandra.jimenez.barrio@uva.es.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Marín-Zurdo', 'Affiliation': 'ID_ERGO Research group, I3A, Department: Design and Manufacturing Engineering. University of Zaragoza, Spain. Electronic address: jjmarin@unizar.es.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Moreno-Calvo', 'Affiliation': 'ID_ERGO Research group, I3A, Department: Design and Manufacturing Engineering. University of Zaragoza, Spain. Electronic address: alexmor1993@hotmail.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Marín-Boné', 'Affiliation': 'ID_ERGO Research group, I3A, Department: Design and Manufacturing Engineering. University of Zaragoza, Spain. Electronic address: javiermar1993@gmail.com.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Albarova-Corral', 'Affiliation': 'Department of Physiatrist and Nursey, Faculty of Health Sciencies, University of Zaragoza, c/Domingo Miral s/n, 50010, Zaragoza, Spain. Electronic address: isabelalbarova@gmail.com.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Estébanez-de-Miguel', 'Affiliation': 'Department of Physiatrist and Nursey, Faculty of Health Sciencies, University of Zaragoza, c/Domingo Miral s/n, 50010, Zaragoza, Spain. Electronic address: elesteba@unizar.es.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102443']
994,32507446,"A pilot study of the effect of curcumin on epigenetic changes and DNA damage among patients with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled, clinical trial.","BACKGROUND
The enhancement of oxidative stress in non-alcoholic fatty liver disease (NAFLD) patients may cause mutation in DNA by deamination of cytosine to 5-hydroxyuracil or uracil. This study aimed to discover the effects of curcumin on NAFLD progress, DNA damage caused by oxidative stress, and promoter methylation of mismatch repair enzymes.
MATERIAL AND METHODS
in this study, 54 NAFLD patients were randomly devided into two groups, according to a double blind parallel design either phytosomal curcumin (250 mg/day) or placebo for 8 weeks. Fasting blood samples and anthropometric measures were taken twice, once at the baseline and once at the end of the study. Promoter methylation and 8-hydroxy-2' -deoxyguanosine (8-OHdG) concentration as DNA damage mediator were measured by restriction enzymes and enzyme-linked immunosorbent assay, respectively.
RESULT
Analysis was performed on 44 patients. According to our between groups analysis, curcumin significantly reduced the methylation in MutL homolog 1 (MLH1) and MutS homolog 2 (MSH2) promoter regions. The within-group comparison revealed that anthropometric variables significantly decreased. However, the result of the between groups comparison indicated no significant changes in the anthropometric variables except for BMI. Liver enzymes and 8-OHdG did not significantly change at the end of the study, neither in curcumin group nor in placebo group.
CONCLUSION
Curcumin might be able to reduce the risk of mismatch base pair in DNA among the NAFLD patients. However, it did not change the DNA damage mediator and liver enzymes. For confirming these results, more studies with longer duration, more numbers of examined genes, higher dose of curcumin, and larger sample size are required.",2020,"Liver enzymes and 8-OHdG did not significantly change at the end of the study, neither in curcumin group nor in placebo group.
","['44 patients', '54 NAFLD patients', 'non-alcoholic fatty liver disease (NAFLD) patients', 'patients with non-alcoholic fatty liver disease']","['curcumin', 'phytosomal curcumin', 'placebo']","['DNA damage mediator and liver enzymes', 'Fasting blood samples and anthropometric measures', 'Liver enzymes and 8-OHdG', 'epigenetic changes and DNA damage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C1516924', 'cui_str': 'Epigenetic Process'}]",54.0,0.27031,"Liver enzymes and 8-OHdG did not significantly change at the end of the study, neither in curcumin group nor in placebo group.
","[{'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Hariri', 'Affiliation': 'Noncommunicable Diseases Research Center, Neyshabur University of Medical Sciences, Neyshabur, Iran. Electronic address: Haririm1@nums.ac.ir.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Gholami', 'Affiliation': 'Noncommunicable Diseases Research Center, Neyshabur University of Medical Sciences, Neyshabur, Iran; Department of Epidemiology & Biostatistics, School of Public Health, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Mirhafez', 'Affiliation': 'Noncommunicable Diseases Research Center, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bidkhori', 'Affiliation': 'Noncommunicable Diseases Research Center, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Amirhosein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran; School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102447']
995,32514040,A registered replication study on oxytocin and trust.,"In an influential paper, Kosfeld et al. (2005) showed that intranasal administration of oxytocin (OT) increases the transfers made by investors in the trust game-suggesting that OT increases trust in strangers. Subsequent studies investigating the role of OT in the trust game found inconclusive effects on the trusting behaviour of investors but these studies deviated from the Kosfeld et al. study in an important way-they did not implement minimal social contact (MSC) between the investors and the trustees in the trust game. Here, we performed a large double-blind and placebo-controlled replication study of the effects of OT on trusting behaviour that yields a power of more than 95% and implements an MSC condition as well as a no-social-contact (NoC) condition. We find no effect of OT on trusting behaviour in the MSC condition. Exploratory post hoc analyses suggest that OT may increase trust in individuals with a low disposition to trust in the NoC condition, but this finding requires confirmation in future research. PROTOCOL REGISTRATION: The stage 1 protocol for this Registered Report was accepted in principle on 19 October 2018. The protocol, as accepted by the journal, can be found at https://doi.org/10.6084/m9.figshare.11980368.",2020,"Exploratory post hoc analyses suggest that OT may increase trust in individuals with a low disposition to trust in the NoC condition, but this finding requires confirmation in future research.",[],"['OT', 'oxytocin', 'oxytocin (OT', 'placebo']",[],[],"[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0573493,"Exploratory post hoc analyses suggest that OT may increase trust in individuals with a low disposition to trust in the NoC condition, but this finding requires confirmation in future research.","[{'ForeName': 'Carolyn H', 'Initials': 'CH', 'LastName': 'Declerck', 'Affiliation': 'Faculty of Business and Economics, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Boone', 'Affiliation': 'Faculty of Business and Economics, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Pauwels', 'Affiliation': 'Faculty of Business and Economics, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Bodo', 'Initials': 'B', 'LastName': 'Vogt', 'Affiliation': 'Chair in Empirical Economics and Health Economics, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Fehr', 'Affiliation': 'Laboratory for Social and Neural Systems Research, Department of Economics, University of Zurich, Zurich, Switzerland. ernst.fehr@econ.uzh.ch.'}]",Nature human behaviour,['10.1038/s41562-020-0878-x']
996,32526502,The effect of rumination and distraction on auditory hallucinatory experiences: An analogue experimental study.,"BACKGROUND AND OBJECTIVES
The cognitive model of voices suggests that negative appraisals of hallucinatory experiences result in responses, such as rumination, which maintain voice-hearing. Our principal aim was to investigate the effect of rumination on the frequency of voice-hearing.
METHODS
A two-group randomised experimental design was employed using a non-clinical sample. A total of 106 participants completed baseline measures of trait rumination, hallucination-proneness, mood and state negative affect, and were presented with a voice-hearing paradigm. False feedback designed to cause a negative interpretation of auditory intrusions was provided and participants were randomly allocated to either a distraction or rumination condition. Participants performed the auditory task for a second time, and the total number of false alarms and distress scores were compared between groups.
RESULTS
A Mann-Whitney U test revealed that the manipulation of rumination was successful (p = 0.007). We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores.
LIMITATIONS
Findings largely relate to a female undergraduate psychology sample.
CONCLUSION
Results of this non-clinical study do not support the hypothesis that rumination leads to an increase in the frequency of voice-hearing on a laboratory task.",2020,"We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores.
","['106 participants completed baseline measures of trait rumination, hallucination-proneness, mood and state negative affect, and were presented with a voice-hearing paradigm', 'auditory hallucinatory experiences', 'female undergraduate psychology sample']","['distraction or rumination condition', 'rumination and distraction']","['distress', 'auditory task', 'total number of false alarms and distress scores', 'frequency of voice-hearing']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]",106.0,0.0413272,"We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores.
","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hartley', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Pennine Care NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Morrison', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Bucci', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK. Electronic address: sandra.bucci@manchester.ac.uk.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101592']
997,32527511,Initial testing of a computer-based simulation training module to support clinicians' acquisition of CBT skills for substance use disorder treatment.,"Cognitive behavioral therapy (CBT) is one of the most common and effective treatments for substance use disorders (SUD); however, effective delivery of CBT depends on a wide variety of nuanced skills that require practice to master. We created a computer-based simulation training system to support the development of necessary skills for student trainees to be able to apply CBT effectively for clients with SUDs. CBT: Introducing Cognitive Behavioral Therapy is an interactive, role-play simulation that provides opportunities for clinician trainees to hone their skills through repeated practice and real-time feedback before application in a clinical setting. This is the first study that tests whether such a simulation improves trainee skills for the treatment of clients with SUDs. Graduate students (N = 65; social work, clinical psychology) completed standardized patient (SP) interviews, were randomized to the simulation training program or manual comparison condition (Project MATCH manual), and completed SP interviews three months post-baseline. Using general linear models, results indicated a significant time x group effect, with students assigned to the simulation training program showing greater improvement in ""extensiveness"" and ""skillfulness"" ratings across three skill categories: general agenda setting (p = .03), explaining CBT concepts (p = .007), and understanding of CBT concepts (p = .001). However, manual comparison participants showed greater improvement than simulation trainees in ""assessing primary drug use"" (p range = .013-.024). No changes in extensiveness or skillfulness of motivational interviewing (MI) style were observed. This pilot test of CBT: Introducing Cognitive Behavioral Therapy offers support for use of this novel technology as a potential approach to scale up CBT training for students, and perhaps clinicians, counseling people with SUDs.",2020,"However, manual comparison participants showed greater improvement than simulation trainees in ""assessing primary drug use"" (p range = .013-.024).","['students, and perhaps clinicians, counseling people with SUDs', 'clients with SUDs', 'Graduate students (N\xa0=\xa065; social work, clinical psychology) completed standardized patient (SP) interviews']","['Cognitive behavioral therapy (CBT', 'CBT', 'simulation training program or manual comparison condition (Project MATCH manual), and completed SP interviews three months post-baseline']","['extensiveness or skillfulness of motivational interviewing (MI) style', 'extensiveness"" and ""skillfulness"" ratings', 'trainee skills']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0033912', 'cui_str': 'Clinical Psychology'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0439795', 'cui_str': 'Extensiveness'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]",65.0,0.013923,"However, manual comparison participants showed greater improvement than simulation trainees in ""assessing primary drug use"" (p range = .013-.024).","[{'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'Binghamton University, College of Community and Public Affairs, PO Box 6000, Binghamton, NY 13902, United States of America. Electronic address: nmastrol@binghamton.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Humm', 'Affiliation': 'SIMmersion, LLC, 8681 Robert Fulton Drive #E, Columbia, MD 21046, United States of America.'}, {'ForeName': 'Callon M', 'Initials': 'CM', 'LastName': 'Williams', 'Affiliation': 'Binghamton University, College of Community and Public Affairs, PO Box 6000, Binghamton, NY 13902, United States of America.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Kiluk', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, Temple Medical Center, 40 Temple St., Suite 6C, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Hoadley', 'Affiliation': 'Brown University, Center for Alcohol and Addiction Studies, School of Public Health, Box G S-121-5, Providence, RI 02912, United States of America.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Magill', 'Affiliation': 'Brown University, Center for Alcohol and Addiction Studies, School of Public Health, Box G S-121-5, Providence, RI 02912, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108014']
998,32542854,Efficacy and safety of tadalafil vs tamsulosin in lower urinary tract symptoms (LUTS) as a result of benign prostate hyperplasia (BPH)-open label randomised controlled study.,"INTRODUCTION & AIM
Several newer medications have emerged for the management of lower urinary tract symptoms secondary to benign prostate hyperplasia (BPH). The efficacy/safety of PDE-5 inhibitors (Tadalafil 5 mg) in BPH-lower urinary tract symptoms (LUTS) has been sparingly assessed in the published English literature as compared with their established role in erectile dysfunction. We aim to assess the efficacy/safety of tadalafil vs tamsulosin in symptomatic patients of BPH in a tertiary care teaching institution.
METHODS
After obtaining an informed written consent and institutional ethics clearance, 100 patients of BPH with an IPSS score of more than 7, without any complications of the disease were computer randomised to receive therapy with either tamsulosin 0.4 mg or tadalafil 5 mg once daily for a period of 2 months. They were evaluated for its efficacy (IPSS, Peak flow rate, IIEF-5, quality of life index [QOL] and PVR) and safety (side effect profile) with monthly visit assessments for 2 months. Data were analysed statistically using ANOVA and unpaired t-tests.The protocol was registered with the CTRI/2018/03/012825.
RESULTS
Patients in both groups were comparable on basis of their demographic data, renal function, PSA and baseline efficacy parameters. Significant improvements were visualised amongst/within both groups for IPSS, however the intergroup improvement was not significant (P = .096). Similar trends were seen with peak flow rate and PVR with intergroup improvement differences not being significant (P = .552 and P = .131, respectively).Improvements in QOL index were more significant in the tamsulosin group (mean difference -2.3 vs -3.06 P = .010).The adverse effects were minor and were managed symptomatically without any drug discontinuity.
CONCLUSIONS
In summary, therefore, we may conclude that that once daily monotherapy with tadalafil 5 mg or tamsulosin 0.4 mg was equally efficacious in the management of moderate to severely bothersome LUTS in majority of patients as a result of BPH. The role of Tadalafil monotherapy in BPH patients with predominant storage LUTS merits further evaluation with larger trials.",2020,"Significant improvements were visualised amongst/within both groups for IPSS, however the intergroup improvement was not significant (P = .096).","['BPH patients with predominant storage LUTS', 'symptomatic patients of BPH in a tertiary care teaching institution', '100 patients of BPH with an IPSS score of more than 7, without any complications of the disease']","['tamsulosin', 'Tadalafil monotherapy', 'tadalafil', 'tamsulosin 0.4\xa0mg or tadalafil', 'tadalafil vs tamsulosin', 'PDE-5 inhibitors (Tadalafil']","['demographic data, renal function, PSA and baseline efficacy parameters', 'efficacy (IPSS, Peak flow rate, IIEF-5, quality of life index [QOL] and PVR) and safety (side effect profile', 'Efficacy and safety', 'QOL index', 'efficacy/safety', 'peak flow rate and PVR']","[{'cui': 'C1704272', 'cui_str': 'Benign prostatic hyperplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C1318700', 'cui_str': 'Phosphodiesterase 5 inhibitor'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0729283', 'cui_str': 'Peak flow rate (respiratory)'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0242852', 'cui_str': 'Proliferative vitreoretinopathy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0394427,"Significant improvements were visualised amongst/within both groups for IPSS, however the intergroup improvement was not significant (P = .096).","[{'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery (Urology), University College of Medical Sciences (University of Delhi) & GTB Hospital, Delhi, India.'}, {'ForeName': 'Aravind', 'Initials': 'A', 'LastName': 'Tk', 'Affiliation': 'Department of Surgery (Urology), University College of Medical Sciences (University of Delhi) & GTB Hospital, Delhi, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Surgery (Urology), University College of Medical Sciences (University of Delhi) & GTB Hospital, Delhi, India.'}]",International journal of clinical practice,['10.1111/ijcp.13530']
999,32535407,An investigation of the impact of social exclusion on attachment to possessions and saving behaviors.,"BACKGROUND AND OBJECTIVES
Hoarding disorder (HD) is a debilitating mental illness characterized by extreme difficulty parting with possessions and clutter that can result in dangerous living conditions. One hypothesis about why individuals with HD save possessions is that they possess a pathological attachment to their belongings, which may serve to compensate for unfulfilling interpersonal relationships. However, there is a dearth of empirical work examining this. The current study examined the impact of an experimental manipulation of social exclusion on attachment to possessions and saving behaviors in a sample of individuals with elevated hoarding symptoms.
METHODS
Participants (n = 117) were selected for scoring above the non-clinical mean on a measure of hoarding symptoms. Participants were randomized to either be included or excluded in a game of Cyberball. They completed a behavioral discarding task and object attachment measure before and after completion of the game.
RESULTS
Study condition was unrelated to in vivo attachment to possessions and saving behaviors during the discarding task. However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task.
LIMITATIONS
Limitations include the use of a non-clinical and homogeneous sample.
CONCLUSIONS
Taken together, individuals prone to feelings of rejection may be at risk for developing HD as they may use possessions to cope with interpersonal stress. Results will be discussed in light of implications for theoretical models and potential treatment targets in HD.",2020,"However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task.
","['individuals with elevated hoarding symptoms', 'Participants (n\xa0=\xa0117']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],[],117.0,0.034374,"However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task.
","[{'ForeName': 'Brittany M', 'Initials': 'BM', 'LastName': 'Mathes', 'Affiliation': 'Florida State University, United States.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Florida State University, United States. Electronic address: schmidt@psy.fsu.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101588']
1000,32506421,Author response to: Comment on: Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT).,,2020,,['proctological surgery'],"['ropivacaine', 'placebo']",[],"[{'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.573461,,"[{'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Steinemann', 'Affiliation': 'Clarunis, Pelvic Floor Unit, University Centre for Gastrointestinal and Liver Diseases, St Clara Hospital and University Hospital Basle, Basle, Switzerland.'}]",The British journal of surgery,['10.1002/bjs.11744']
1001,32506458,Comment on: Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT).,,2020,,['proctological surgery'],"['ropivacaine', 'placebo']",[],"[{'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.651947,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Parello', 'Affiliation': 'Proctology Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCSS.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ratto', 'Affiliation': 'Proctology Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCSS.'}]",The British journal of surgery,['10.1002/bjs.11745']
1002,32520718,Dose-Response Relationship of a Web-Based Tailored Intervention Promoting Human Papillomavirus Vaccination: Process Evaluation of a Randomized Controlled Trial.,"BACKGROUND
In the Netherlands, human papillomavirus (HPV) vaccination uptake remains low. To improve informed decision making (IDM) and HPV vaccination acceptability, we systematically developed an interactive, web-based tailored intervention to which mothers of Dutch girls were invited to participate.
OBJECTIVE
The aim of this study was to provide insight into the intervention's working mechanisms by evaluating (1) program use, (2) program acceptability, and (3) the relationship of program use with program acceptability and intervention effects (ie, dose-response relationship).
METHODS
Only mothers from the intervention arm of a randomized controlled trial that assessed the effectiveness of the web-based, tailored intervention were included in this study. They were invited to visit the website of the web-based intervention between baseline (January 2015, just before access to the intervention) and follow up (March 2015, prior to the first HPV vaccination). Indicators for program use were time of website use (ie, duration of intervention exposure) and completeness (ie, proportion of all available web pages visited). HPV vaccination uptake registered by Praeventis was used as the primary outcome. Secondary outcomes were IDM, decisional conflict, and social-psychological determinants of HPV vaccination uptake.
RESULTS
Among the 3995 invited mothers, 2509 (62.80%) logged on to the website, 2239 of whom (89.24%) visited at least one page of the intervention components. On average, mothers spent 21.39 minutes (SD 12.41) on the website and completed 50.04% (SD 26.18%) of the website components. Participants rated the website 7.64 (SD 1.39) on a 10-point scale. Program acceptability was significantly associated with completeness (β=4.36, P<.001), but not with time of website use (β=-.07, P=.77). Intention-to-treat analysis (N=3995) showed a significant positive effect of completeness on all outcome measures (all P<.003; Bonferroni-corrected α=.05/15 factors), including on HPV vaccination uptake. Time of website use had a significant positive effect on all outcomes (all P<.003), except for uptake (P=.20), risk perception when not vaccinated (P=.14), subjective norms (P=.03), and habit (P=.01).
CONCLUSIONS
Program use and acceptability of the intervention were adequate. Completeness was positively associated with acceptability. Furthermore, positive effects (ie, dose-response effects) were found for completeness and time of website use on the mothers' IDM, decisional conflict, and almost all of the social-psychological determinants of HPV vaccination acceptability. In addition, the extent to which mothers completed the intervention had a positive impact on their daughters' vaccination uptake. This indicates that the web-based, tailored intervention fits well with the mothers' needs, and that completeness of use is essential for improving HPV vaccination uptake, acceptability, and IDM. Program use should therefore be promoted.
TRIAL REGISTRATION
Netherlands Trial Register NTR4795; https://www.trialregister.nl/trial/4795.",2020,"Time of website use had a significant positive effect on all outcomes (P's <.003), except for uptake (P = .195), risk perception when not vaccinated (P = .144), subjective norms (P = .032), and habit (P = .013).
","['mothers of Dutch girls to-be-invited', '3995 invited mothers, 2509 mothers (62.80%) logged in', '2239 mothers (89.24%) visited at least one page of the intervention components']",[],"['decision-making (IDM), decisional conflict, and social psychological determinants of HPV vaccination uptake', 'Program acceptability', 'risk perception', 'HPV vaccination uptake', 'HPV vaccination uptake, acceptability, and IDM', 'completeness and time of website use on the mothers IDM, decisional conflict, and almost all of the social-psychological determinants of HPV vaccination acceptability', 'subjective norms']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",[],"[{'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}]",3995.0,0.0847614,"Time of website use had a significant positive effect on all outcomes (P's <.003), except for uptake (P = .195), risk perception when not vaccinated (P = .144), subjective norms (P = .032), and habit (P = .013).
","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Pot', 'Affiliation': 'Child Health, Netherlands Organization for Applied Scientific Research (TNO), Leiden, Netherlands.'}, {'ForeName': 'Theo Gwm', 'Initials': 'TG', 'LastName': 'Paulussen', 'Affiliation': 'Child Health, Netherlands Organization for Applied Scientific Research (TNO), Leiden, Netherlands.'}, {'ForeName': 'Robert Ac', 'Initials': 'RA', 'LastName': 'Ruiter', 'Affiliation': 'Department of Work and Social Psychology, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Mollema', 'Affiliation': 'National Institute for Public Health and the Environment (RIVM), Centre for Infectious Disease Control, Bilthoven, Netherlands.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Hofstra', 'Affiliation': 'Child Health, Netherlands Organization for Applied Scientific Research (TNO), Leiden, Netherlands.'}, {'ForeName': 'Hilde M', 'Initials': 'HM', 'LastName': 'Van Keulen', 'Affiliation': 'Child Health, Netherlands Organization for Applied Scientific Research (TNO), Leiden, Netherlands.'}]",Journal of medical Internet research,['10.2196/14822']
1003,32532267,Efficacy of nano-carbonate apatite dentifrice in relief from dentine hypersensitivity following non-surgical periodontal therapy: a randomized controlled trial.,"BACKGROUND
Dentine hypersensitivity (DH) could occur or intensify after non-surgical periodontal therapy because of the exposure of dentine tubules, but currently no gold standard exists to treat DH. It has been demonstrated that nano-sized particles presented potential for dentine tubules blocking and remineralization. This randomized controlled trial aimed to investigate the efficacy of dentifrice containing nano-carbonate apatite (n-CAP) in reducing dentine hypersensitivity (DH) after non-surgical periodontal therapy.
METHODS
48 periodontitis patients with DH were included in this clinical trial. After non-surgical periodontal therapy, patients included were randomized to test and control group and the respective dentifrices were applied at chairside, after which they were instructed to brush teeth with the allocated dentifrices twice a day at home. Periodontal parameters were recorded at baseline and the last follow-up. DH was measured by air-blast test and recorded by visual analogue scale (VAS) and Schiff sensitivity scale at baseline, after polishing (0 week) and 2/4/6 weeks.
RESULTS
45 participants completed the follow-up. Periodontal parameters were improved and comparable between groups. Significant reduction in DH was observed in both groups at all time-points compared to baseline in terms of VAS and Schiff score. The test group achieved significantly greater relief from hypersensitivity compared with the control group after 4-week at-home use (for change of VAS, test group: 2.27 ± 2.47 versus control group: 1.68 ± 2.24, p = 0.036; for change of Schiff, test group: 0.94 ± 0.92 versus control group: 0.61 ± 0.83, p < 0.001). The 6-week results showed borderline significance between groups in terms of change of Schiff (p = 0.027) and no significance in terms of change of VAS (p = 0.256).
CONCLUSIONS
Home-use of n-CAP based dentifrice had some benefit on alleviation of DH following non-surgical periodontal therapy after 4 weeks compared to the control product.
TRIAL REGISTRATION
Chinese Clinical Trials Registry (No. ChiCTR-IPR-17011678, http://www.chictr.org.cn/, registered 16 June, 2017).",2020,Significant reduction in DH was observed in both groups at all time-points compared to baseline in terms of VAS and Schiff score.,"['48 periodontitis patients with DH', '45 participants completed the follow-up', 'dentine hypersensitivity following non-surgical periodontal therapy']","['nano-carbonate apatite dentifrice', 'dentifrice containing nano-carbonate apatite (n-CAP']","['DH', 'dentine hypersensitivity (DH', 'alleviation of DH', 'relief from hypersensitivity', 'change of VAS', 'Periodontal parameters', 'visual analogue scale (VAS) and Schiff sensitivity scale', 'change of Schiff']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0054675', 'cui_str': 'Carbapatite'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",48.0,0.0479244,Significant reduction in DH was observed in both groups at all time-points compared to baseline in terms of VAS and Schiff score.,"[{'ForeName': 'Pei-Hui', 'Initials': 'PH', 'LastName': 'Ding', 'Affiliation': 'Department of Periodontology, Affiliated Hospital of Stomatology, School of Medicine, Hangzhou, China.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dai', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Zhejiang University School of Stomatology, Hangzhou, China.'}, {'ForeName': 'Hua-Jiao', 'Initials': 'HJ', 'LastName': 'Hu', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Zhejiang University School of Stomatology, Hangzhou, China.'}, {'ForeName': 'Jia-Ping', 'Initials': 'JP', 'LastName': 'Huang', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Zhejiang University School of Stomatology, Hangzhou, China.'}, {'ForeName': 'Jia-Mei', 'Initials': 'JM', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Zhejiang University School of Stomatology, Hangzhou, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Zhejiang University School of Stomatology, Hangzhou, China. chenlili_1030@zju.edu.cn.'}]",BMC oral health,['10.1186/s12903-020-01157-9']
1004,32537887,Secondary analyses to assess the profound effects of empagliflozin on endothelial function in patients with type 2 diabetes and established cardiovascular diseases: The placebo-controlled double-blind randomized effect of empagliflozin on endothelial function in cardiovascular high risk diabetes mellitus: Multi-center placebo-controlled double-blind randomized trial.,"AIMS/INTRODUCTION
Recent clinical trials on sodium-glucose cotransporter 2 inhibitors showed improved outcomes in patients with type 2 diabetes at a high risk of cardiovascular events. However, the underlying effects on endothelial function remain unclear.
MATERIALS AND METHODS
The effect of empagliflozin on endothelial function in cardiovascular high risk diabetes mellitus: Multi-center placebo-controlled double-blind randomized (EMBLEM) trial in patients with type 2 diabetes and cardiovascular disease showed empagliflozin treatment for 24 weeks had no effect on peripheral endothelial function measured by reactive hyperemia peripheral arterial tonometry. This post-hoc analysis of the EMBLEM trial included a detailed evaluation of the effects of empagliflozin on peripheral endothelial function in order to elucidate the clinical characteristics of responders or non-responders to treatment.
RESULTS
Of the 47 patients randomized into the empagliflozin group, 21 (44.7%) showed an increase in the reactive hyperemia index (RHI) after 24 weeks of intervention, with no apparent difference in the clinical characteristics between patients whose RHI either increased (at least >0) or did not increase. There was also no obvious difference between the treatment groups in the proportion of patients who had a clinically meaningful change (≥15%) in log-transformed RHI. No correlation was found between changes in RHI and clinical variables, such as vital signs and laboratory parameters.
CONCLUSIONS
Treatment with empagliflozin for 24 weeks in patients with type 2 diabetes and cardiovascular disease did not affect peripheral endothelial function, and was not related to changes in clinical variables, including glycemic parameters. These findings suggest that the actions of sodium-glucose cotransporter 2 inhibitors other than direct improvement in peripheral endothelial function were responsible, at least in the early phase, for the clinical benefits found in recent cardiovascular outcome trials.",2020,"No correlation was found between changes in RHI and clinical variables, such as vital signs and laboratory parameters.
","['cardiovascular high risk diabetes mellitus', 'patients with type\xa02 diabetes and cardiovascular disease showed', 'patients with type\xa02 diabetes and established cardiovascular diseases', 'patients with type\xa02 diabetes at a high risk of cardiovascular events']","['Multi-center placebo', 'empagliflozin', 'placebo']","['endothelial function', 'reactive hyperemia peripheral arterial tonometry', 'peripheral endothelial function', 'reactive hyperemia index (RHI', 'RHI and clinical variables, such as vital signs and laboratory parameters']","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",47.0,0.253742,"No correlation was found between changes in RHI and clinical variables, such as vital signs and laboratory parameters.
","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Shimabukuro', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Noritaka', 'Initials': 'N', 'LastName': 'Machii', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Teragawa', 'Affiliation': 'Department of Cardiovascular Medicine, JR Hiroshima Hospital, Hiroshima, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Kosuke R', 'Initials': 'KR', 'LastName': 'Shima', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Takamura', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Taguchi', 'Affiliation': 'Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Hisauchi', 'Affiliation': 'Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Matsuzawa', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Minako', 'Initials': 'M', 'LastName': 'Yamaoka-Tojo', 'Affiliation': 'Department of Rehabilitation, Kitasato University School of Allied Health Sciences, Sagamihara, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, University of the Ryukyus, Nishihara, Japan.'}, {'ForeName': 'Yukihito', 'Initials': 'Y', 'LastName': 'Higashi', 'Affiliation': 'Department of Cardiovascular Regeneration and Medicine, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13289']
1005,32527195,Expiratory Muscle Strength Training in patients After Total Laryngectomy; A Feasibility Pilot Study.,"OBJECTIVES
Expiratory muscle strength training (EMST) is a threshold based device-driven treatment for improving expiratory pressure. EMST proved to be effective in different patient groups to improve cough function. To date, EMST has not been tested in the total laryngectomy population (TL).
METHODS
This prospective, randomized case-series study examined feasibility, safety, and compliance of EMST in a group of TL participants and its effects on pulmonary function, physical exertion, fatigue, and vocal functioning. Ten TL participants were included in the study to perform a 4 till 8 weeks of EMST. Objective and subjective outcome measures included manometry, spirometry, cardio pulmonary exercise testing (CPET), voice recordings, and patient reported outcome measures. Group means were reported and estimates of the effect are shown with a 95% confidence interval, using single sample t-tests.
RESULTS
Nine participants completed the full study protocol. Compliance to the training program was high. All were able to perform the training, although it requires adjustments of the device and skills of the participants. Maximum expiratory pressure (MEP) and vocal functioning in loudness improved over time. After EMST no changes were seen in other objective and subjective outcomes.
CONCLUSIONS
EMST appears to be feasible and safe after total laryngectomy. MEP improved over time but no improvement in the clinically relevant outcome measures were seen in this sample of relatively fit participants. Further investigation of the training in a larger group of participants who report specifically pulmonary complaints is recommended to investigate if the increase in MEP results in clinical benefits.
LEVEL OF EVIDENCE
4.",2020,"After EMST no changes were seen in other objective and subjective outcomes.
","['patients', 'Ten TL participants were included in the study to perform a 4 till 8\u2009weeks of EMST']","['Expiratory Muscle Strength Training', 'MEP', 'Expiratory muscle strength training (EMST', 'EMST']","['Maximum expiratory pressure (MEP) and vocal functioning in loudness improved over time', 'pulmonary function, physical exertion, fatigue, and vocal functioning', 'cough function', 'manometry, spirometry, cardio pulmonary exercise testing (CPET), voice recordings, and patient reported outcome measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0189231', 'cui_str': 'Total laryngectomy'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}]","[{'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C1532868', 'cui_str': 'Vocal function'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}]",10.0,0.0790339,"After EMST no changes were seen in other objective and subjective outcomes.
","[{'ForeName': 'Klaske E', 'Initials': 'KE', 'LastName': 'van Sluis', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Anne F', 'Initials': 'AF', 'LastName': 'Kornman', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Wim G', 'Initials': 'WG', 'LastName': 'Groen', 'Affiliation': 'Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Michiel W M', 'Initials': 'MWM', 'LastName': 'van den Brekel', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Lisette', 'Initials': 'L', 'LastName': 'van der Molen', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Bari', 'Initials': 'B', 'LastName': 'Hoffman-Ruddy', 'Affiliation': 'School of Communication Sciences and Disorders, University of Central Florida, Orlando, FL, USA.'}, {'ForeName': 'Martijn M', 'Initials': 'MM', 'LastName': 'Stuiver', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Noord-Holland, The Netherlands.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489420931889']
1006,32532483,Beta Testing of a Gestational Diabetes Risk Reduction Intervention for American Indian and Alaska Native Teens.,"INTRODUCTION
American Indian and Alaska Native (AIAN) girls have double the risk of obesity, pregnancy, and gestational diabetes mellitus (GDM) than the general U.S.
POPULATION
The purpose of this study was to beta test Stopping GDM (SGDM), a GDM risk reduction intervention for at-risk AIAN teens, before beginning a randomized controlled trial.
METHOD
A sample of 11 AIAN mothers and daughters were recruited through an urban Indian health program. Daughters were at risk of GDM as assessed by a BMI ≥ 85th percentile. Pre- and posttest online questionnaires evaluated the online intervention (e-book and video).
RESULTS
Mean pre- to posttest knowledge increased for mothers and daughters on diabetes prevention, reproductive health, and GDM knowledge. Daughters demonstrated an increased self-efficacy for healthy living and pregnancy planning. Satisfaction for the e-book, video, and online survey was moderately high to very high.
DISCUSSION
The SGDM intervention is feasible and acceptable in AIAN mother-daughter dyads. These findings informed the SGDM intervention and the randomized controlled trial evaluation protocol.",2020,"Mean pre- to posttest knowledge increased for mothers and daughters on diabetes prevention, reproductive health, and GDM knowledge.","['A sample of 11 AIAN mothers and daughters were recruited through an urban Indian health program', 'American Indian and Alaska Native Teens']","['SGDM intervention', 'Stopping GDM (SGDM), a GDM risk reduction intervention', 'Gestational Diabetes Risk Reduction Intervention']","['diabetes prevention, reproductive health, and GDM knowledge', 'self-efficacy']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",11.0,0.0333475,"Mean pre- to posttest knowledge increased for mothers and daughters on diabetes prevention, reproductive health, and GDM knowledge.","[{'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ''}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Stotz', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Yesenia', 'Initials': 'Y', 'LastName': 'Garcia-Reyes', 'Affiliation': ''}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': ''}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Stein', 'Affiliation': ''}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Charron-Prochownik', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2020.04.005']
1007,32539506,"In MRSA bacteremia, adding a β-lactam to usual care did not improve a composite outcome at 90 days.","SOURCE CITATION
Tong SY, Lye DC, Yahav D, et al. Effect of vancomycin or daptomycin with vs without an antistaphylococcal β-lactam on mortality, bacteremia, relapse, or treatment failure in patients with MRSA bacteremia: a randomized clinical trial. JAMA. 2020;323:527-37. 32044943.",2020,"Effect of vancomycin or daptomycin with vs without an antistaphylococcal β-lactam on mortality, bacteremia, relapse, or treatment failure in patients with MRSA bacteremia: a randomized clinical trial. ",['patients with MRSA bacteremia'],['vancomycin or daptomycin'],"['mortality, bacteremia, relapse, or treatment failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040349', 'cui_str': 'Bacteremia due to Methicillin resistant Staphylococcus aureus'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0057144', 'cui_str': 'Daptomycin'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}]",,0.0665675,"Effect of vancomycin or daptomycin with vs without an antistaphylococcal β-lactam on mortality, bacteremia, relapse, or treatment failure in patients with MRSA bacteremia: a randomized clinical trial. ","[{'ForeName': 'Eleftheria', 'Initials': 'E', 'LastName': 'Atalla', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA (E.A., E.M.).'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Mylonakis', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA (E.A., E.M.).'}]",Annals of internal medicine,['10.7326/ACPJ202006160-067']
1008,32539655,Effects of a high-intensity psychosocial intervention among child-parent units in pediatric oncology.,"AIM
To compare the efficacy of a high-intensity psychosocial intervention with standardized usual care in countering psychosocial complexity among child-parent units in a pediatric oncology setting.
METHODS
Two hundred pediatric oncology patients and their parents were recruited from Italian hospitals. A total of 81 child-parent units were assigned to the high-intensity psychosocial intervention and 119 child-parent units to standardized usual care. Psychosocial factors were assessed before and 1 year after intervention to measure efficacy.
RESULTS
More improvements over time were observed in the high-intensity intervention group of child-parent units compared to the standard intervention group.
CONCLUSION
An intensive, structured, and tailored high-intensity intervention positively affects the psychosocial factors of child-parent units. Patients and families should have access to intensive psychosocial support throughout the cancer trajectory.",2020,"RESULTS
More improvements over time were observed in the high-intensity intervention group of child-parent units compared to the standard intervention group.
","['81 child-parent units', 'child-parent units in pediatric oncology', 'Two hundred pediatric oncology patients and their parents were recruited from Italian hospitals', 'child-parent units in a pediatric oncology setting']","['high-intensity psychosocial intervention', 'high-intensity psychosocial intervention with standardized usual care', 'high-intensity psychosocial intervention and 119 child-parent units to standardized usual care']",['Psychosocial factors'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}]",200.0,0.0358755,"RESULTS
More improvements over time were observed in the high-intensity intervention group of child-parent units compared to the standard intervention group.
","[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Zucchetti', 'Affiliation': 'Pediatric Oncology Division, Azienda Ospedaliera-Universitaria Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Ambrogio', 'Affiliation': 'Pediatric Division, ASL CN 1, Savigliano, Cuneo, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Bertolotti', 'Affiliation': 'Pediatric Oncology Division, Azienda Ospedaliera-Universitaria Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Besenzon', 'Affiliation': 'Pediatric Division, ASL CN 1, Savigliano, Cuneo, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Borghino', 'Affiliation': 'Pediatric Division, ASL CN 1, Savigliano, Cuneo, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Candela', 'Affiliation': 'University of Turin, Turin, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Galletto', 'Affiliation': 'Pediatric Division, ASL CN 1, Savigliano, Cuneo, Italy.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Fagioli', 'Affiliation': 'Pediatric Oncology Division, Azienda Ospedaliera-Universitaria Città della Salute e della Scienza, Turin, Italy.'}]",Tumori,['10.1177/0300891620926226']
1009,32540321,Perioperative Dexamethasone Is Associated With Higher Short-Term Mortality in Reconstructive Head and Neck Cancer Surgery.,"PURPOSE
Studies of the effects of perioperative dexamethasone (DEX) during oncologic surgery are scarce. The first aim of the present study was to clarify whether perioperative DEX affects the short-term mortality in patients with head and neck cancer (HNC). The second aim was to analyze the causes of death and predictors affecting long-term mortality.
PATIENTS AND METHODS
The present prospective, double-blind randomized, controlled study included patients with HNC who had undergone microvascular reconstruction from 2008 through 2013. The patients were randomized into 2 groups: the receipt of perioperative DEX for 3 days (study group) or no DEX (control group). The patients' data and cause of death were registered until the end of 2017. The primary cause of death was used in the analyses.
RESULTS
A total of 93 patients were included in the present study: 51 in the DEX group (study group) and 42 in the NON-DEX group (control group). Altogether 38 patients died during a median follow-up period of 5.3 years. During the first year, more deaths had occurred in the DEX group than in the NON-DEX group: at 1 month, 4% versus 0%; at 6 months, 14% versus 0%; and at 12 months, 22% versus 5% (P = .043). The overall survival rate for all patients was 59%. HNC was the primary cause of death for most of the patients who died. On univariate analysis, the deceased patients had more advanced disease (higher T classification, P = .002; higher stage, P = .008), a greater need for a gastrostoma (P = .002), more often received postoperative chemotherapy (P = .005), and more often had locoregional (P = .025) or distal (P < .001) metastases. In the multivariate Cox model, the most important long-term predictors of death were the presence of distant metastases (P < .001), a Charlson comorbidity index (CCI) of 5 to 9 (P < .001), and the use of perioperative DEX (P = .004).
CONCLUSIONS
The use of perioperative DEX was associated with higher short-term mortality after reconstructive HNC surgery. The most important long-term predictors of death were the receipt of DEX, the presence of distant metastases, and a CCI of 5 to 9. These findings do not encourage the routine use of perioperative DEX for these patients.",2020,"On univariate analysis, the deceased patients had more advanced disease (higher T classification, P = .002; higher stage, P = .008), a greater need for a gastrostoma (P = .002), more often received postoperative chemotherapy (P = .005), and more often had locoregional (P = .025) or distal (P < .001) metastases.","['A total of 93 patients were included in the present study: 51 in the DEX group (study group) and 42 in the NON-DEX group (control group', 'patients with HNC who had undergone microvascular reconstruction from 2008 through 2013', 'Reconstructive Head and Neck Cancer Surgery', 'patients with head and neck cancer (HNC']","['perioperative DEX', 'DEX', 'no DEX', 'Perioperative Dexamethasone', 'perioperative dexamethasone (DEX']","['overall survival rate', 'death', 'deaths', 'Charlson comorbidity index (CCI', 'advanced disease']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",93.0,0.0680807,"On univariate analysis, the deceased patients had more advanced disease (higher T classification, P = .002; higher stage, P = .008), a greater need for a gastrostoma (P = .002), more often received postoperative chemotherapy (P = .005), and more often had locoregional (P = .025) or distal (P < .001) metastases.","[{'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Kainulainen', 'Affiliation': 'Consultant, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland. Electronic address: satu.kainulainen@hus.fi.'}, {'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Aro', 'Affiliation': 'Consultant, Department of Otorhinolaryngology-Head and Neck Surgery, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Koivusalo', 'Affiliation': 'Consultant and Docent, Department of Anesthesia and Intensive Care Unit, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Wilkman', 'Affiliation': 'Consultant, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Risto P', 'Initials': 'RP', 'LastName': 'Roine', 'Affiliation': 'Professor Emeritus, Department of Health and Social Management, University of Eastern Finland, Kuopio; and Professor Emeritus, Group Administration, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Aronen', 'Affiliation': 'Biostatistics Consultant, Department of Public Health, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jyrki', 'Initials': 'J', 'LastName': 'Törnwall', 'Affiliation': 'Docent, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Lassus', 'Affiliation': 'Department Head and Docent, Department of Plastic Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.004']
1010,32541882,Understanding how a community-based intervention for people with spinal cord injury in Bangladesh was delivered as part of a randomised controlled trial: a process evaluation.,"DESIGN
Mixed methods study SETTING: Community, Bangladesh OBJECTIVES: To understand how a community-based intervention for people with spinal cord injury (SCI) in Bangladesh was delivered as part of a randomised controlled trial and to gauge the perceptions of participants and healthcare professionals to the intervention.
METHODS
A community-based intervention was administered to 204 participants as part of a large randomised controlled trial (called the CIVIC trial). Case-managers followed-up participants with regular telephone calls and home visits over the first 2 years after discharge. The following data were collected alongside the trial: (i) chart audit of telephone calls and home visits (ii) recordings of 20 telephone calls (iii) interviews with 14 Intervention participants and four healthcare professionals including three case-managers.
RESULTS
Participants received the target number of telephone calls and home visits. Pressure injuries were identified as a problem during at least one telephone call by 43% of participants. Participants and case-managers valued regular telephone calls and home visits, and believed that calls and visits prevented complications and alleviated social isolation. Participants trusted case-managers and were confident in the care and advice provided. Case-managers expressed concerns that people with SCI in Bangladesh face many problems impacting on well-being and motivation stemming from poverty, limited employment opportunities, societal attitudes and inaccessible environments.
CONCLUSION
A community-based intervention involving regular telephone calls and home visits was administered as intended and was well received by the recipients of the care. Nonetheless, people with SCI in Bangladesh face economic and social problems which cannot be fully addressed by this type of intervention alone.",2020,A community-based intervention involving regular telephone calls and home visits was administered as intended and was well received by the recipients of the care.,"['people with spinal cord injury in Bangladesh', '204 participants as part of a large randomised controlled trial (called the CIVIC trial', 'people with spinal cord injury (SCI) in Bangladesh']","['community-based intervention', 'telephone calls and home visits (ii) recordings of 20 telephone calls (iii) interviews with 14 Intervention participants and four healthcare professionals including three case-managers']",['Pressure injuries'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0687694', 'cui_str': 'Case manager'}]","[{'cui': 'C0332679', 'cui_str': 'Crushing injury'}]",204.0,0.0864356,A community-based intervention involving regular telephone calls and home visits was administered as intended and was well received by the recipients of the care.,"[{'ForeName': 'Hueiming', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Mohammad Sohrab', 'Initials': 'MS', 'LastName': 'Hossain', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Kolling Institute, Sydney Medical School/Northern, University of Sydney, St Leonards, NSW, Australia.'}, {'ForeName': 'Md Shofiqul', 'Initials': 'MS', 'LastName': 'Islam', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Md Akhlasur', 'Initials': 'MA', 'LastName': 'Rahman', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Punam D', 'Initials': 'PD', 'LastName': 'Costa', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Herbert', 'Affiliation': 'Neuroscience Research Australia, Barker Street, Randwick, NSW, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Cameron', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Kolling Institute, Sydney Medical School/Northern, University of Sydney, St Leonards, NSW, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Muldoon', 'Affiliation': 'Muldoon Rehabilitation, 72 Liscreevin Road, Lisnarick, Co Fermanagh, BT, Northern Ireland, Northern Ireland.'}, {'ForeName': 'Harvinder S', 'Initials': 'HS', 'LastName': 'Chhabra', 'Affiliation': 'Indian Spinal Injuries Centre, Sector C, Vasant Kunj, New Delhi, India.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Fin', 'Initials': 'F', 'LastName': 'Biering-Sorensen', 'Affiliation': 'Clinic for Spinal Cord Injuries, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Ducharme', 'Affiliation': 'Boston Medical Centre and Boston University School of Medicine, 725 Albany street, Boston, MA, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Taylor', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Harvey', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Kolling Institute, Sydney Medical School/Northern, University of Sydney, St Leonards, NSW, Australia. l.harvey@usyd.edu.au.'}]",Spinal cord,['10.1038/s41393-020-0495-6']
1011,32546648,Predictive Value of Molecular Subtypes in Premenopausal Women with Hormone Receptor-positive Early Breast Cancer: Results from the ABCSG Trial 5.,"PURPOSE
To assess the predictive value of molecular breast cancer subtypes in premenopausal patients with hormone receptor-positive early breast cancer who received adjuvant endocrine treatment or chemotherapy.
EXPERIMENTAL DESIGN
Molecular breast cancer subtypes were centrally assessed on whole tumor sections by IHC in patients of the Austrian Breast and Colorectal Cancer Study Group Trial 5 who had received either 5 years of tamoxifen/3 years of goserelin or six cycles of cyclophosphamide, methotrexate, and fluorouracil (CMF). Luminal A disease was defined as Ki67 <20% and luminal B as Ki67 ≥20%. The luminal B/HER2-positive subtype displayed 3+ HER2-IHC or amplification by ISH. Recurrence-free survival (RFS) and overall survival (OS) were analyzed using Cox models adjusted for clinical and pathologic factors.
RESULTS
185 (38%), 244 (50%), and 59 (12%) of 488 tumors were classified as luminal A, luminal B/HER2-negative and luminal B/HER2-positive, respectively. Luminal B subtypes were associated with poor outcome. Patients with luminal B tumors had a significantly shorter RFS [adjusted HR for recurrence: 2.22; 95% confidence interval (CI), 1.41-3.49; P = 0.001] and OS (adjusted HR for death: 3.51; 95% CI, 1.80-6.87; P < 0.001). No interaction between molecular subtypes and treatment was observed (test for interaction: P = 0.84 for RFS; P = 0.69 for OS).
CONCLUSIONS
Determination of molecular subtypes by IHC is an independent prognostic factor for recurrence and death in premenopausal women with early-stage, hormone receptor-positive breast cancer but is not predictive for outcome of adjuvant treatment with tamoxifen/goserelin or CMF. See related commentary by Hunter et al., p. 5543 .",2020,"Patients with Luminal B tumors had a significantly shorter RFS (adjusted hazard ratio [HR] for recurrence: 2.22, 95% confidence interval [CI] 1.41-3.49, P = 0.001) and OS (adjusted HR for death: 3.51, 95% CI 1.80-6.87, P < 0.001).","['premenopausal hormone receptor-positive early breast cancer patients who received', 'premenopausal women with hormone receptor-positive early breast cancer', 'Trial 5 who had received either 5 years of tamoxifen/3 years of goserelin or six cycles of', 'premenopausal women with early-stage, hormone receptor-positive breast cancer', 'Molecular breast cancer subtypes were centrally assessed on whole tumor sections by immunohistochemistry (IHC) in patients of the Austrian Breast and Colorectal Cancer Study Group (ABCSG']","['tamoxifen/goserelin or CMF', 'adjuvant endocrine treatment or chemotherapy', 'cyclophosphamide, methotrexate, and fluorouracil (CMF']","['Luminal A disease', 'Recurrence-free survival (RFS) and overall survival (OS', 'shorter RFS']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0337795', 'cui_str': 'Austrians'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",488.0,0.183225,"Patients with Luminal B tumors had a significantly shorter RFS (adjusted hazard ratio [HR] for recurrence: 2.22, 95% confidence interval [CI] 1.41-3.49, P = 0.001) and OS (adjusted HR for death: 3.51, 95% CI 1.80-6.87, P < 0.001).","[{'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Bago-Horvath', 'Affiliation': 'Department of Pathology, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Margaretha', 'Initials': 'M', 'LastName': 'Rudas', 'Affiliation': 'Institute of Cancer Research, Department of Medicine I, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Singer', 'Affiliation': 'Department of Gynecology, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'III Medical Department, Salzburg Cancer Research Institute, Cancer Cluster Salzburg, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Balic', 'Affiliation': 'Department of Internal Medicine, Division of Oncology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Sigurd F', 'Initials': 'SF', 'LastName': 'Lax', 'Affiliation': 'Department of Pathology, Hospital Graz II, Graz, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Kwasny', 'Affiliation': 'Department of Surgery, Hospital Wiener Neustadt, Wiener Neustadt, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hulla', 'Affiliation': 'Department of Pathology, Hospital Wiener Neustadt, Wiener Neustadt, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Comprehensive Cancer Center, Medical University Vienna, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Filipits', 'Affiliation': 'Institute of Cancer Research, Department of Medicine I, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria. martin.filipits@meduniwien.ac.at.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0673']
1012,32540277,High blood pressure responders show largest increase in heartbeat perception accuracy after post-learning stress following a cardiac interoceptive learning task.,"Mental disorders with physical symptoms, e.g. somatic symptom disorder, are characterized by altered interoceptive accuracy (IAc), which can be explained by individual differences in interoceptive learning (IL). We investigated if stress facilitates IL. Seventy-three healthy participants performed a heartbeat counting task (HCT: T1) and a heartbeat perception training (HBPT). After exposure to a socially-evaluated cold pressor stress test (SECPT; n = 48) or a control condition (n = 25), two more HCTs were performed (T2: 30 min after SECPT; T3: 24 h later). After the HBPT, all participants showed an increase in IAc. We separated the stress group into high vs. low systolic blood pressures (SBP) responders (n = 24 each), with high SBP responders showing the largest IAc increases. Only SBP, but not cortisol responsiveness significantly predicted IAc increase from T1 to T2. Our results indicate that post-learning autonomic stress response facilitates IL, whereas the HPA axis response may be less important for this effect.",2020,"Only SBP, but not cortisol responsiveness significantly predicted IAc increase from T1 to T2.","['Seventy-three healthy participants', 'Mental disorders with physical symptoms, e.g. somatic symptom disorder']","['heartbeat counting task (HCT: T1) and a heartbeat perception training (HBPT', 'SECPT']","['HPA axis response', 'IAc', 'systolic blood pressures (SBP) responders', 'heartbeat perception accuracy']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4087321', 'cui_str': 'Somatic symptom disorder'}]","[{'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",73.0,0.014762,"Only SBP, but not cortisol responsiveness significantly predicted IAc increase from T1 to T2.","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Schenk', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Jean T M', 'Initials': 'JTM', 'LastName': 'Fischbach', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Müller', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Vögele', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Witthöft', 'Affiliation': 'Division of Clinical Psychology, Department of Psychology, Johannes Gutenberg University of Mainz, Mainz, Germany.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Van Diest', 'Affiliation': 'Department of Health Psychology, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schulz', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg. Electronic address: andre.schulz@uni.lu.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107919']
1013,32541365,Multicenter visual outcomes comparison of 2 trifocal presbyopia-correcting IOLs: 6-month postoperative results.,"PURPOSE
To clinically evaluate visual performance of the AcrySof IQ PanOptix TFNT00 and AT LISA tri 839MP intraocular lenses (IOLs) in binocular visual acuity (VA) and to characterize low-contrast visual performance at 6 months postimplantation.
SETTING
Multicenter, 15 sites.
DESIGN
Prospective, parallel-group, randomized, double-masked, postmarketing clinical study.
METHODS
Binocular uncorrected distance (UDVA, 4 m), intermediate (UIVA, 60 cm), and near (UNVA, 40 cm) visual acuities and binocular defocus curves were evaluated under photopic lighting conditions. Photopic and mesopic contrast sensitivities with and without glare were assessed.
RESULTS
The study included 182 subjects (62% women; mean age, 66 ± 9.4 years) who were implanted bilaterally with the TFNT00 IOL (n = 93) or 839MP IOL (n = 89), and binocular VA was evaluated 4 to 6 months (120-180 days) postimplantation. The TFNT00 IOL group showed superior visual outcomes compared with the 839MP IOL group in binocular UIVA (P = .001) and UNVA (P = .003) and noninferior outcomes in UDVA (95% CI, -0.023 to 0.041; upper limit <0.1 logarithm of the minimum angle of resolution [logMAR] [margin of noninferiority]). Mean defocus curve from 0.00 to -3.00 diopter (D) ranged from 0.1 to 0.0 logMAR for both IOLs; better mean VA values (logMAR) were observed in the TFNT00 IOL group between -1.50 and -2.50 D compared with those of the 839MP IOL group. Contrast sensitivity values were similar between the 2 groups in all conditions.
CONCLUSIONS
The results of this study showed improved visual performance at near and intermediate distances with the TFNT00 IOL compared with that of the 839MP IOL.",2020,"The TFNT00 group showed superior visual outcomes compared with the 839MP group in binocular UIVA (P=0.001), UNVA (P=0.003) and noninferior outcomes in UDVA (95% CI, -0.023 to 0.041; upper limit <0.1 logMAR [logarithm of the minimum angle of resolution] [margin of noninferiority]).","['study included182 subjects (62% female; mean age, 66±9.4 years) who were implanted bilaterally with the TFNT00 IOL (n=93) or 839MP IOL (n=89), and binocular VA was evaluated 4 to 6 months (120-180 days) post-implantation', 'Multicenter, 15 sites']","['PURPOS', 'AcrySof IQ PanOptix TFNT00 and AT LISA tri 839MP intraocular lenses (IOLs', '2 trifocal presbyopia-correcting intraocular lenses']","['UNVA', 'mean VA values (logMAR', 'visual performance', 'superior visual outcomes', 'Contrast sensitivity values', 'binocular UIVA', 'Binocular uncorrected distance (UDVA, 4 m), intermediate (UIVA, 60 cm), near (UNVA, 40 cm) VAs, and binocular defocus curves', 'Photopic and mesopic contrast sensitivity with and without glare']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0033075', 'cui_str': 'Presbyopia'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0278215', 'cui_str': 'Glare'}]",,0.0929871,"The TFNT00 group showed superior visual outcomes compared with the 839MP group in binocular UIVA (P=0.001), UNVA (P=0.003) and noninferior outcomes in UDVA (95% CI, -0.023 to 0.041; upper limit <0.1 logMAR [logarithm of the minimum angle of resolution] [margin of noninferiority]).","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lapid-Gortzak', 'Affiliation': 'From the Department of Ophthalmology, Amsterdam University Medical Centers (Lapid-Gortzak), Amsterdam, Netherlands; Vision Eye Institute (Bhatt), Melbourne, Victoria, Australia; Instituto Nacional de Investigacion en Oftalmologia (Sanchez), Medellin-Antioquia, Colombia; Valles Oftalmologia Recerca (Guarro), Barcelona, Spain; Hospital Oftalmologico de Brasilia (Hida), Brasilia, Brazil; Personal Eyes (Bala), Sydney, New South Wales, Australia; Eye Clinic (Nosé), São Paulo, Brazil; Fundacion Oftalmologica Nacional, Universidad del Rosario (Alvira), Bogota, Colombia; Alcon Vision LLC (Martinez), Fort Worth, Texas, USA.'}, {'ForeName': 'Uday', 'Initials': 'U', 'LastName': 'Bhatt', 'Affiliation': ''}, {'ForeName': 'Juan Gonzalo', 'Initials': 'JG', 'LastName': 'Sanchez', 'Affiliation': ''}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Guarro', 'Affiliation': ''}, {'ForeName': 'Wilson Takashi', 'Initials': 'WT', 'LastName': 'Hida', 'Affiliation': ''}, {'ForeName': 'Chandra', 'Initials': 'C', 'LastName': 'Bala', 'Affiliation': ''}, {'ForeName': 'Ricardo Menon', 'Initials': 'RM', 'LastName': 'Nosé', 'Affiliation': ''}, {'ForeName': 'Francisco Jose', 'Initials': 'FJ', 'LastName': 'Rodriguez Alvira', 'Affiliation': ''}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000274']
1014,32534972,"Comparison of Clinical Performance of VectorFlow and Palindrome Symmetric-Tip Dialysis Catheters: A Multicenter, Randomized Trial.","PURPOSE
To compare clinical performance of 2 widely used symmetric-tip hemodialysis catheters.
MATERIALS AND METHODS
Patients with end-stage renal disease initiating or resuming hemodialysis were randomized to receive an Arrow-Clark VectorFlow (n = 50) or Palindrome catheter (n = 50). Primary outcome was 90-d primary unassisted catheter patency. Secondary outcomes were Kt/V ([dialyzer urea clearance × total treatment time]/total volume of urea distribution), urea reduction ratio (URR), and effective blood flow (Q B ).
RESULTS
Primary unassisted patency rates with the VectorFlow catheter at 30, 60, and 90 d were 95.5% ± 3.3, 87.2% ± 7.3, and 80.6% ± 9.8, respectively, compared with 89.1% ± 6.2, 79.4% ± 10.0, and 71.5% ± 12.6 with the Palindrome catheter (P = .20). Patients with VectorFlow catheters had a mean Kt/V of 1.5 at 30-, 60-, and 90-day time points, significantly higher than the mean Kt/V of 1.3 among those with Palindrome catheters (P = .0003). URRs were not significantly different between catheters. Catheter Q B rates exceeded National Kidney Foundation-recommended thresholds of 300 mL/min at all time points for both catheters and were similar for both catheters (median, 373 mL/min). Catheter failure, ie, poor flow rate requiring guide-wire exchange or removal, within the 90-day primary outcome occurred in 3 VectorFlow subjects and 5 Palindrome subjects (P = .72). Infection rates were similar, with 0.98 infections per 1,000 catheter days for VectorFlow catheters compared with 2.62 per 1,000 catheter days for Palindrome catheters (P = .44).
CONCLUSIONS
The 90-day primary patency rates of Palindrome and VectorFlow catheters were not significantly different, and both achieved sustained high Q B through 90 day follow-up. However, dialysis adequacy based on Kt/V was consistently better with the VectorFlow catheter versus the Palindrome.",2020,"Catheter Q B rates exceeded National Kidney Foundation-recommended thresholds of 300 mL/min at all time points for both catheters and were similar for both catheters (median, 373 mL/min).",['Patients with end-stage renal disease initiating or resuming hemodialysis'],"['VectorFlow catheters', 'VectorFlow catheter versus the Palindrome', 'Arrow-Clark VectorFlow (n\xa0= 50) or Palindrome catheter', 'VectorFlow and Palindrome Symmetric-Tip Dialysis Catheters']","['Kt/V ([dialyzer urea clearance', '90-day primary patency rates of Palindrome and VectorFlow catheters', 'patency rates', '90-d primary unassisted catheter patency', 'Infection rates', 'Catheter failure, ie, poor flow rate requiring guide-wire exchange or removal', 'urea distribution), urea reduction ratio (URR), and effective blood flow (Q B ', 'URRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0336721', 'cui_str': 'Arrow'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0179747', 'cui_str': 'Dialysis catheter'}]","[{'cui': 'C0429662', 'cui_str': 'kt/V'}, {'cui': 'C1318428', 'cui_str': 'Urea clearance measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0429664', 'cui_str': 'Urea reduction ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",,0.066622,"Catheter Q B rates exceeded National Kidney Foundation-recommended thresholds of 300 mL/min at all time points for both catheters and were similar for both catheters (median, 373 mL/min).","[{'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Nadolski', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104. Electronic address: gregory.nadolski@pennmedicine.upenn.edu.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Redmond', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Shin', 'Affiliation': 'Penn State Health Radiology, Hershey, Pennsylvania.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Shamimi-Noori', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Ansar', 'Initials': 'A', 'LastName': 'Vance', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hammelman', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Timothy W I', 'Initials': 'TWI', 'LastName': 'Clark', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Cohen', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rudnick', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2020.02.001']
1015,32552366,Enhancing agency for health providers and pregnant women experiencing intimate partner violence in South Africa.,"Global policy frameworks call for strengthening the role of health systems to address intimate partner violence (IPV) and support women's agency, yet the evidence of health system responses remains slender in low- and middle-income countries (LMICs). In South Africa, 25-35% of pregnant women experience IPV, posing long-term health risks. We utilised agency as a theoretical construct, applying qualitative methods to investigate health professionals' experiences of a randomised controlled trial intervention to address IPV in pregnant women in five antenatal clinics (ANC) in Johannesburg (2011-2016). In-depth interviews ( n = 16) were supplemented by participant observation, debriefing and field notes. Health providers viewed the intervention as enhancing health promotion agency and advancing help-seeking agency for IPV-exposed patients. Intervention nurses reported their own self-efficacy improved , and their relational and collective agency expanded . On-going supervision, mentorship and feedback were essential to establish the knowledge and skill-building necessary for providers to improve self-efficacy in intervention delivery. Integrating mental health services into primary ANC services is recommended. Findings offer insight into the untapped potential for LMIC health settings to become transformative, gender-responsive social systems, for patients and health professionals, in ways that advance women's agency, health, human rights and SDGs.",2020,"Findings offer insight into the untapped potential for LMIC health settings to become transformative, gender-responsive social systems, for patients and health professionals, in ways that advance women's agency, health, human rights and SDGs.","['pregnant women in five antenatal clinics (ANC) in Johannesburg (2011-2016', 'health providers and pregnant women experiencing intimate partner violence in South Africa']",[],[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}]",[],[],,0.0228113,"Findings offer insight into the untapped potential for LMIC health settings to become transformative, gender-responsive social systems, for patients and health professionals, in ways that advance women's agency, health, human rights and SDGs.","[{'ForeName': 'Courtenay', 'Initials': 'C', 'LastName': 'Sprague', 'Affiliation': 'Department of Conflict Resolution, Human Security & Global Governance, McCormack Graduate School of Policy and Global Studies, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Nataly', 'Initials': 'N', 'LastName': 'Woollett', 'Affiliation': 'School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Hatcher', 'Affiliation': 'School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}]",Global public health,['10.1080/17441692.2020.1780290']
1016,32532631,Lower donor site morbidity and higher patient satisfaction with epidermal grafting in comparison to split thickness skin grafting: A randomized controlled trial (EPIGRAAFT Trial).,"BACKGROUND
Split thickness skin grafting (SSG) is an important modality for wound coverage; however, it leads to donor site morbidity. Epidermal grafting (EG) is a promising option for autologous skin grafting which offers minimal donor site morbidity, though it is not known if EG is an effective clinical alternative for SSG. This study compared the efficacy of EG as an alternative to SSG in terms of wound healing outcomes, donor site morbidity, patient satisfaction and adverse events.
METHODS
EPIGRAAFT is a Phase 2, randomized, open-label trial with two parallel groups: EG and SSG. Patients referred for skin grafting with a healthy granulating wound bed were included. The co-primary endpoints were the proportion of wounds healed and donor site healing time. The secondary endpoints include donor site morbidity measured using Vancouver Scar Scale, mean time for complete wound healing, patient satisfaction assessed using a validated skin grafting questionnaire and incidence of adverse events.
RESULTS
Of the 61 patients screened, 44 patients were randomized. There was no difference in the proportion of wounds healed at 6 weeks (p=0.366) and 3 months(p=0.24) as well as the mean time for wound healing (p=0.12). EG resulted in lower donor site morbidity (p=0.001), faster donor site healing time (EG: 4.86 days vs. SSG: 21.32 days) (p<0.0001), and higher overall satisfaction (p<0.001). There were no adverse events reported.
CONCLUSION
This study demonstrated that EG has superior donor site outcomes with faster donor site healing and lower morbidity compared to SSG, while having comparable wound healing outcomes. Patients receiving EG also experienced higher donor site satisfaction compared to SSG. ClinicalTrials.gov identifier: NCT02535481.",2020,"EG resulted in lower donor site morbidity (p=0.001), faster donor site healing time (EG: 4.86 days vs. SSG: 21.32 days) (p<0.0001), and higher overall satisfaction (p<0.001).","['Patients referred for skin grafting with a healthy granulating wound bed were included', '61 patients screened, 44 patients were randomized']","['Split thickness skin grafting (SSG', 'split thickness skin grafting', 'Epidermal grafting (EG']","['overall satisfaction', 'mean time for wound healing', 'lower donor site morbidity', 'faster donor site healing time', 'proportion of wounds healed and donor site healing time', 'higher donor site satisfaction', 'wound healing outcomes, donor site morbidity, patient satisfaction and adverse events', 'donor site morbidity measured using Vancouver Scar Scale, mean time for complete wound healing, patient satisfaction assessed using a validated skin grafting questionnaire and incidence of adverse events', 'proportion of wounds healed', 'Lower donor site morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0037297', 'cui_str': 'Grafting to skin'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0439061', 'cui_str': 'Split thickness skin graft (procedure)'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0037297', 'cui_str': 'Grafting to skin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",44.0,0.0865935,"EG resulted in lower donor site morbidity (p=0.001), faster donor site healing time (EG: 4.86 days vs. SSG: 21.32 days) (p<0.0001), and higher overall satisfaction (p<0.001).","[{'ForeName': 'Muholan', 'Initials': 'M', 'LastName': 'Kanapathy', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, United Kingdom; Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Bystrzonowski', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, United Kingdom.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Hachach-Haram', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, United Kingdom.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Twyman', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, United Kingdom.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Becker', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore; Institute of Medical Biology, A*Star, Immunos, Biomedical Grove, Singapore.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Richards', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, United Kingdom; Faculty of Health and Medical Sciences, University of Western Australia. Electronic address: toby.richards@uwa.edu.au.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Mosahebi', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, United Kingdom; Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, United Kingdom.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2020.03.006']
1017,32534376,Fatty acid desaturation in red blood cell membranes of patients with type 2 diabetes is improved by zinc supplementation.,"BACKGROUND/OBJECTIVE
Membrane flexibility can be a determining factor in pathophysiological mechanisms of type 2 diabetes (T2D). As a cofactor of delta-5 desaturase (D5D) and delta-6 desaturase (D6D), and gene expression regulator, zinc may play a role modulating membrane flexibility by increasing membrane polyunsaturated fatty acids (PUFA) abundance. The objective of this study was to evaluate the effect of a 24-month zinc supplementation (30 mg elemental zinc) on membrane fatty acid composition in patients with T2D.
SUBJECTS/METHODS
Sixty patients with T2D were evaluated. Thirty were randomly assigned to the zinc supplemented group and thirty to the placebo group. Fatty acid composition in red blood cell (RBC) membranes was determined by gas chromatography. Expression of gene encoding for D5D (FADS1), and D6D (FADS2) were evaluated in peripheral blood mononuclear cells by real-time polymerase chain reaction.
RESULTS
After 24 months of supplementation, a greater abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA was found (p = 0.001, p = 0.007, p = 0.033, p = 0.048, respectively). The unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index was increased in the zinc supplemented group at month 24 (p = 0.003 and p = 0.000, respectively). FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
CONCLUSIONS
Supplementation with 30 mg/d elemental zinc during 24 months in patients with T2D had an effect on the composition of RBC membranes increasing PUFA abundance and in turn, improving membrane flexibility. This effect may be mediated by induction of D5D gene expression.",2020,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","['patients with T2D', 'Sixty patients with T2D were evaluated', 'patients with type 2 diabetes']","['Fatty acid desaturation', 'zinc supplementation (30\u202fmg elemental zinc', 'placebo']","['membrane flexibility', 'Expression of gene encoding for D5D (FADS1), and D6D (FADS2', 'Fatty acid composition in red blood cell (RBC) membranes', 'abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA', 'FADS1 gene', 'unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index', 'membrane fatty acid composition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0057338', 'cui_str': 'delta-5 fatty acid desaturase'}, {'cui': 'C0065017', 'cui_str': 'Linoleoyl-CoA desaturase'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0050877', 'cui_str': 'adrenic acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.126956,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","[{'ForeName': 'María Catalina', 'Initials': 'MC', 'LastName': 'Hernández', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rojas', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Carrasco', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basfi-Fer', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Valenzuela', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Codoceo', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Inostroza', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruz', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile. Electronic address: mruz@med.uchile.cl.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126571']
1018,32541288,Cost of Elective Labor Induction Compared With Expectant Management in Nulliparous Women.,"OBJECTIVE
To compare the actual health-system cost of elective labor induction at 39 weeks of gestation with expectant management.
METHODS
This was an economic analysis of patients enrolled in the five Utah hospitals participating in a multicenter randomized trial of elective labor induction at 39 weeks of gestation compared with expectant management in low-risk nulliparous women. The entire trial enrolled more than 6,000 patients. For this subset, 1,201 had cost data available. The primary outcome was relative direct health care costs of maternal and neonatal care from a health system perspective. Secondary outcomes included the costs of each phase of maternal and neonatal care. Direct health system costs of maternal and neonatal care were measured using advanced costing analytics from the time of randomization at 38 weeks of gestation until exit from the study up to 8 weeks postpartum. Costs in each randomization arm were compared using generalized linear models and reported as the relative cost of induction compared with expectant management. With a fixed sample size, we had adequate power to detect a 7.3% or greater difference in overall costs.
RESULTS
The total cost of elective induction was no different than expectant management (mean difference +4.7%; 95% CI -2.1% to +12.0%; P=.18). Maternal outpatient antenatal care costs were 47.0% lower in the induction arm (95% CI -58.3% to -32.6%; P<.001). Maternal inpatient intrapartum and delivery care costs, conversely, were 16.9% higher among women undergoing labor induction (95% CI +5.5% to +29.5%; P=.003). Maternal inpatient postpartum care, maternal outpatient care after discharge, neonatal hospital care, and neonatal care after discharge did not differ between arms.
CONCLUSION
Total costs of elective labor induction and expectant management did not differ significantly. These results challenge the assumption that elective induction of labor leads to significant cost escalation.",2020,Maternal outpatient antenatal care costs were 47.0% lower in the induction arm (95% CI -58.3% to -32.6%; P<.001).,"['low-risk nulliparous women', 'patients enrolled in the five Utah hospitals participating', '6,000 patients', 'Nulliparous Women']","['Expectant Management', 'elective labor induction', 'expectant management']","['Maternal outpatient antenatal care costs', 'total cost of elective induction', 'Maternal inpatient postpartum care, maternal outpatient care after discharge, neonatal hospital care, and neonatal care after discharge', 'costs of each phase of maternal and neonatal care', 'overall costs', 'Cost of Elective Labor Induction', 'relative direct health care costs of maternal and neonatal care from a health system perspective', 'Maternal inpatient intrapartum and delivery care costs']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042124', 'cui_str': 'Utah'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C1171257', 'cui_str': 'Delivery care'}]",,0.122938,Maternal outpatient antenatal care costs were 47.0% lower in the induction arm (95% CI -58.3% to -32.6%; P<.001).,"[{'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Einerson', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and the Division of Epidemiology, Department of Internal Medicine, University of Utah Health, Intermountain Healthcare, and the IDEAS Center, VA Salt Lake City Healthcare System, Salt Lake City, Utah; George Washington University Biostatistics Center, Washington, DC; the Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'Grecio', 'Initials': 'G', 'LastName': 'Sandoval', 'Affiliation': ''}, {'ForeName': 'M Sean', 'Initials': 'MS', 'LastName': 'Esplin', 'Affiliation': ''}, {'ForeName': 'D Ware', 'Initials': 'DW', 'LastName': 'Branch', 'Affiliation': ''}, {'ForeName': 'Torri D', 'Initials': 'TD', 'LastName': 'Metz', 'Affiliation': ''}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': ''}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Varner', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003930']
1019,32534578,"Rationale and design of an investigator-initiated, multicenter, prospective open-label, randomized trial to evaluate the effect of ipragliflozin on endothelial dysfunction in type 2 diabetes and chronic kidney disease: the PROCEED trial.","BACKGROUND
Type 2 diabetes (T2D) is associated with renal impairment and vascular endothelial dysfunction. Therefore, this pathological connection is an important therapeutic target. Recent cardiovascular and renal outcome trials demonstrated that sodium glucose cotransporter 2 inhibitors (SGLT2is) consistently reduced the risks of cardiovascular and renal events and mortality in patients with T2D and various other background risks including chronic kidney disease (CKD). However, the precise mechanisms by which SGLT2is accords these therapeutic benefits remain uncertain. It is also unknown whether these SGLT2is-associated benefits are associated with the amelioration of endothelial dysfunction in patients with T2D and CKD.
METHODS
The PROCEED trial is an investigator-initiated, prospective, multicenter, open-label, randomized-controlled trial. The target sample size is 110 subjects. After they furnish informed consent and their endothelial dysfunction is confirmed from their decreased reactive hyperemia indices (RHI), eligible participants with T2D (HbA1c, 6.0-9.0%) and established CKD (30 mL/min/1.73 m 2 ≤ estimated glomerular filtration ratio [eGFR] < 60 and/or ≥ urine albumin-to-creatinine ratio 30 mg/g Cr) will be randomized (1:1) to receive either 50 mg ipragliflozin daily or continuation of background treatment (non-SGLT2i). The primary endpoint is the change in RHI from baseline after 24 weeks. To compare the treatment effects between groups, the baseline-adjusted means and their 95% confidence intervals will be estimated by analysis of covariance adjusted for HbA1c (< 7.0% or ≥ 7.0%), age (< 70 y or ≥ 70 y), RHI (< 1.67 or ≥ 1.67), eGFR (< 45 mL/min/1.73 m 2 or ≥ 45 mL/min/1.73 m 2 ), and smoking status. Prespecified responder analyses will be also conducted to determine the proportions of patients with clinically meaningful changes in RHI at 24 weeks.
DISCUSSION
PROCEED is the first trial to examine the effects of ipragliflozin on endothelial dysfunction in patients with T2D and CKD. This ongoing trial will establish whether endothelial dysfunction is a therapeutic target of SGLT2is in this population. It will also provide deep insights into the potential mechanisms by which SGLT2is reduced the risks of cardiovascular and renal events in recent outcome trials. Trial registration Unique Trial Number, jRCTs071190054 (https://jrct.niph.go.jp/en-latest-detail/jRCTs071190054).",2020,"After they furnish informed consent and their endothelial dysfunction is confirmed from their decreased reactive hyperemia indices (RHI), eligible participants with T2D (HbA1c, 6.0-9.0%) and established CKD (30 mL","['110 subjects', 'patients with T2D and various other background risks including chronic kidney disease (CKD', 'type 2 diabetes and chronic kidney disease', 'patients with T2D and CKD']","['ipragliflozin daily or continuation of background treatment (non-SGLT2i', 'sodium glucose cotransporter 2 inhibitors (SGLT2is', 'ipragliflozin']","['glomerular filtration ratio [eGFR', 'change in RHI', 'and/or\u2009≥\u2009urine albumin-to-creatinine ratio 30', 'reactive hyperemia indices', 'risks of cardiovascular and renal events and mortality', 'endothelial dysfunction']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}]",,0.113996,"After they furnish informed consent and their endothelial dysfunction is confirmed from their decreased reactive hyperemia indices (RHI), eligible participants with T2D (HbA1c, 6.0-9.0%) and established CKD (30 mL","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan. tanakaa2@cc.saga-u.ac.jp.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Shimabukuro', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'Diabetes Center, Ohta Nishinouchi Hospital, Koriyama, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kurozumi', 'Affiliation': 'Wakamatsu Hospital of the University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Torimoto', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Hirai', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan. node@cc.saga-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular diabetology,['10.1186/s12933-020-01065-w']
1020,32534584,Effect of continuous intraoperative infusion of methoxamine on renal function in elderly patients undergoing gastrointestinal tumor surgery: a randomized controlled trial.,"BACKGROUND
Acute renal injury (AKI) caused by hypotension often occurs in elderly patients after gastrointestinal tumor surgery. Although vasoactive drugs can increase effective filtration pressure, they may increase renal vascular resistance and reduce renal blood flow. The effect of methoxamine on renal function is not clear.
METHODS
After obtaining written informed consent, 180 elderly patients undergoing elective gastrointestinal tumor surgery were randomly allocated into two groups: M group (continuous infusion of methoxamine at 2 μg/kg/min) and N group (continuous infusion of normal saline). The patients' mean arterial pressure was maintained within 20% of baseline by a continuous infusion of methoxamine or normal saline. Maintenance fluid was kept at 5 mL/kg/h. According to Kidney disease improve global outcome (KDIGO) guidelines, creatinine was measured at 1, 2 and 7 days after operation, and urine volume at 6, 12 and 24 h after operation was measured to evaluate the occurrence of AKI. 162 patients were included in the final data analysis.
RESULTS
Significant differences in the incidence of postoperative Acute kidney injury (M group: 7.5%; N group: 18.3%; P < 0.05), the frequency of hypotension (M group: 1 [1-3]; N group: 3 [1-5]; P < 0.05), and the duration of intraoperative hypotension (M group: 2[0-10]; N group: 10 [5-16]; P < 0.05) were identified between the groups. Multivariate logistic regression analyses demonstrated that preoperative creatinine and the frequency of intraoperative hypotension were the common factors leading to the occurrence of postoperative AKI. The results of Cox multivariate analysis showed that age and AKI were independent risk factors for 30-day death.
CONCLUSION
Compared with the intraoperative continuous infusion of placebo and methoxamine, continuous infusion of 2 μg/kg/min methoxamine reduced the incidence of postoperative AKI and other clinical complications in elderly patients undergoing gastrointestinal surgery by raising blood pressure and improved the prognosis of patients.
TRIAL REGISTRATION
Trial registration: Chinese Clinical Trial Registry, ChiCTR1900020536, registered 7 January, 2019.",2020,"RESULTS
Significant differences in the incidence of postoperative Acute kidney injury (M group: 7.5%; N group: 18.3%; P < 0.05), the frequency of hypotension (M group: 1 [1-3]; N group: 3 [1-5]; P < 0.05), and the duration of intraoperative hypotension (M group: 2[0-10]; N group: 10 [5-16]; P < 0.05) were identified between the groups.","['elderly patients after gastrointestinal tumor surgery', 'elderly patients undergoing gastrointestinal tumor surgery', 'elderly patients undergoing gastrointestinal surgery', '180 elderly patients undergoing elective gastrointestinal tumor surgery', '162 patients were included in the final data analysis']","['placebo and methoxamine', 'M group (continuous infusion of methoxamine at 2\u2009μg/kg/min) and N group (continuous infusion of normal saline', 'methoxamine or normal saline', 'continuous intraoperative infusion of methoxamine', 'methoxamine']","['renal function', 'incidence of postoperative AKI', 'renal vascular resistance and reduce renal blood flow', 'frequency of hypotension', 'effective filtration pressure', 'mean arterial pressure', 'global outcome (KDIGO) guidelines, creatinine', 'duration of intraoperative hypotension', 'occurrence of AKI', 'incidence of postoperative Acute kidney injury']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017185', 'cui_str': 'Neoplasm of gastrointestinal tract'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025681', 'cui_str': 'Methoxamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C1278442', 'cui_str': 'Continuous infusion of normal saline'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0042380', 'cui_str': 'Vascular resistance, function'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035070', 'cui_str': 'Circulation, Renal'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",162.0,0.272553,"RESULTS
Significant differences in the incidence of postoperative Acute kidney injury (M group: 7.5%; N group: 18.3%; P < 0.05), the frequency of hypotension (M group: 1 [1-3]; N group: 3 [1-5]; P < 0.05), and the duration of intraoperative hypotension (M group: 2[0-10]; N group: 10 [5-16]; P < 0.05) were identified between the groups.","[{'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University, Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Xuzhou Medical University and Department of Oncology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Hanbing', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University, Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University, Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University, Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University, Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China.'}, {'ForeName': 'Dunyi', 'Initials': 'D', 'LastName': 'Qi', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University, Key Laboratory of Anesthesia and Analgesia, Xuzhou Medical University, Xuzhou, Jangsu, China. qdy6808@163.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01064-0']
1021,32536111,Hemodynamics in young athletes following high-intensity interval or moderate-intensity continuous training.,"BACKGROUND
The present study aimed to investigate the effects of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) on blood pressure (BP) and parameters of arterial stiffness in young athletes.
METHODS
Seventeen rowers (aged 15±1.3 years) were randomized into an intervention group (IG, N.=10) and the control group (CG, N.=7). During an 8-week intervention period, the IG completed a HIIT on the rowing ergometer twice-weekly (2×4×2 min at ≈95% of maximum heart rate [HRmax], 60 s rest) in addition to the regular rowing training (3×/week MICT 70-90 min, ≈70% HRmax). The CG completed the regular normal rowing training and, instead of the HIIT units, two additional MICT units (70-90 min, ≈70% HRmax). Before and after the intervention period, hemodynamic parameters were recorded non-invasively in both groups.
RESULTS
After the intervention period, there was a significant decrease in peripheral systolic (P=0.01) and diastolic (P=0.05) BP, as well as in central systolic (P=0.05) and diastolic BP (P=0.03) in the IG. Furthermore, pulse wave velocity (PWV) (P=0.05) was significantly reduced. Analysis of intervention effects revealed significant between-group differences in central diastolic BP (P=0.05), in augmentation pressure (P=0.02), and in augmentation index (P=0.006) favoring IG. The CG showed no significant changes in the respected parameters throughout the intervention.
CONCLUSIONS
Already in adolescent athletes, a HIIT intervention has beneficial effects on peripheral and central BP as well as on PWV, augmentation pressure, and augmentation index.",2020,"Analysis of intervention effects revealed significant between-group differences in central diastolic BP (p = 0.05), in augmentation pressure (p = 0.02), and in augmentation index (p = 0.006) favoring IG.","['young athletes', 'adolescent athletes', '17 rowers (aged 16±1.4 years', 'young athletes following high-intensity interval or moderate-intensity continuous training']","['control group (CG', 'HIIT intervention', 'HIIT versus moderate-intensity continuous training (MICT', 'regular rowing training']","['central diastolic BP', 'augmentation pressure', 'diastolic BP', 'central systolic', 'pulse wave velocity', 'diastolic', 'augmentation index', 'blood pressure (BP) and parameters of arterial stiffness', 'peripheral systolic', 'hemodynamic parameters']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",,0.0222633,"Analysis of intervention effects revealed significant between-group differences in central diastolic BP (p = 0.05), in augmentation pressure (p = 0.02), and in augmentation index (p = 0.006) favoring IG.","[{'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Ketelhut', 'Affiliation': 'Institute of Sports Science, Martin-Luther-University Halle-Wittenberg, Halle, Germany - sascha.ketelhut@gmail.com.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Kirchenberger', 'Affiliation': 'Medical Center Berlin, Berlin, Germany.'}, {'ForeName': 'Reinhard G', 'Initials': 'RG', 'LastName': 'Ketelhut', 'Affiliation': 'Medical Center Berlin, Berlin, Germany.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10814-4']
1022,32544854,Effect of ZNF804A gene polymorphism (rs1344706) on the plasticity of the functional coupling between the right dorsolateral prefrontal cortex and the contralateral hippocampal formation.,"ZNF804A has now been recognized as a schizophrenia risk gene by multiple genome-wide association studies with its intronic polymorphism rs1344706 being reported as the first genome-wide significant risk variant for schizophrenia. Although the functional impact of this gene is still unknown, rs1344706's contribution to the functional coupling between the right dorsolateral prefrontal cortex (DLPFC) and the contralateral hippocampal formation (HF) has been reported by several studies. The current study tested whether the right DLPFC-left HF functional coupling showed plasticity during cognitive training (Study I) and whether rs1344706 affected the plasticity (Study II). In Study I, we conducted a randomized controlled trial with 30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group). All subjects were scanned using fMRI before and after the training. Analyses of resting-state and task-state fMRI data consistently showed that the adaptive memory span training significantly strengthened the right DLPFC-left HF functional coupling. In Study II, we conducted a genetic association study with 101 subjects (combining the data from the training group in Study I with those from an additional subsequent sample of 71 subjects who received the same training and fMRI scans). Results showed that rs1344706 was significantly associated with training-induced changes in functional coupling. Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes. These findings expanded our current understanding of the functional impact of the schizophrenia risk variant of ZNF804A gene and suggested that the ZNF804A gene could be used as a prospective target for future antipsychotic drugs and clinical research.",2020,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"['101 subjects (combining the data from the training group in Study', '71 subjects who received the same training and fMRI scans', '30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group']","['ZNF804A', 'ZNF804A gene polymorphism (rs1344706']",['functional coupling'],"[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}]",101.0,0.0118036,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"[{'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiongying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qiumei', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China; School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Boqi', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Yu-Tao', 'Initials': 'YT', 'LastName': 'Xiang', 'Affiliation': 'Faculty of Health Sciences, University of Macau, Avenida da Universidade, Taipa, Macau, PR China.'}, {'ForeName': 'Chuanyue', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dong', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Chuansheng', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, CA 92697, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China. Electronic address: lijundp@bnu.edu.cn.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102279']
1023,32549100,Effects of Lidocaine Oropharyngeal Spray Applied Before Endotracheal Intubation on QT Dispersion in Patients Undergoing Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Study.,"OBJECTIVE
To investigate the effects of lidocaine oropharyngeal spray applied before endotracheal intubation on hemodynamic responses and electrocardiographic parameters in patients undergoing coronary artery bypass grafting.
METHODS
A total of 60 patients who underwent coronary artery bypass grafting surgery were included in this prospective randomized controlled study. Patients were randomly divided into two groups, the topical lidocaine group (administration of 10% lidocaine oropharyngeal spray, five minutes before laryngoscopy and endotracheal intubation) and the control group. Both groups were compared with each other in terms of main hemodynamic parameters including mean arterial pressure and heart rate, as well as P and QT wave dispersion durations, before and after endotracheal intubation.
RESULTS
The groups were similar in terms of age, gender, and other demographics and basic clinical characteristics. There was a statistically significant difference between the groups in terms of QT dispersion durations after laryngoscopy and endotracheal intubation. The increase in QT dispersion duration was not statistically significant in the topical lidocaine group, whereas the increase in QT dispersion duration was statistically significant in the control group. When the groups were compared in terms of P wave dispersion durations, there were significant decreases in both groups, but there was no significant difference between the groups.
CONCLUSION
Our study revealed that the topical lidocaine administration before endotracheal intubation prevented increase of QT dispersion duration in patients undergoing coronary artery bypass grafting.
TRIAL REGISTRATION
NCT03304431.",2020,There was a statistically significant difference between the groups in terms of QT dispersion durations after laryngoscopy and endotracheal intubation.,"['60 patients who underwent', 'patients undergoing coronary artery bypass grafting', 'Patients Undergoing Coronary Artery Bypass Grafting']","['Lidocaine Oropharyngeal Spray Applied Before Endotracheal Intubation', 'endotracheal intubation', 'lidocaine oropharyngeal spray, five minutes before laryngoscopy and endotracheal intubation', 'lidocaine', 'topical lidocaine', 'coronary artery bypass grafting surgery', 'lidocaine oropharyngeal spray']","['QT dispersion durations', 'hemodynamic responses and electrocardiographic parameters', 'mean arterial pressure and heart rate, as well as P and QT wave dispersion durations', 'QT Dispersion', 'QT dispersion duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]",60.0,0.0257983,There was a statistically significant difference between the groups in terms of QT dispersion durations after laryngoscopy and endotracheal intubation.,"[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Bilgi', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Velioglu', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Hamit', 'Initials': 'H', 'LastName': 'Yoldas', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Cosgun', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Yuksel', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Karagoz', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Isa', 'Initials': 'I', 'LastName': 'Yildiz', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Abdulhamit', 'Initials': 'A', 'LastName': 'Es', 'Affiliation': 'Abant Izzet Baysal University Faculty of Economics and Administrative Sciences Bolu Turkey Abant Izzet Baysal University Faculty of Economics and Administrative Sciences, Bolu, Turkey.'}, {'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Caliskan', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Kemalettin', 'Initials': 'K', 'LastName': 'Erdem', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Demirhan', 'Affiliation': 'Abant Izzet Baysal University Medical School Bolu Turkey Abant Izzet Baysal University Medical School, Bolu, Turkey.'}]",Brazilian journal of cardiovascular surgery,['10.21470/1678-9741-2019-0112']
1024,32552857,"The OPTIMIZE patient- and family-centered, primary care-based deprescribing intervention for older adults with dementia or mild cognitive impairment and multiple chronic conditions: study protocol for a pragmatic cluster randomized controlled trial.","BACKGROUND
Most individuals with dementia or mild cognitive impairment (MCI) have multiple chronic conditions (MCC). The combination leads to multiple medications and complex medication regimens and is associated with increased risk for significant treatment burden, adverse drug events, cognitive changes, hospitalization, and mortality. Optimizing medications through deprescribing (the process of reducing or stopping the use of inappropriate medications or medications unlikely to be beneficial) may improve outcomes for MCC patients with dementia or MCI.
METHODS
With input from patients, family members, and clinicians, we developed and piloted a patient-centered, pragmatic intervention (OPTIMIZE) to educate and activate patients, family members, and primary care clinicians about deprescribing as part of optimal medication management for older adults with dementia or MCI and MCC. The clinic-based intervention targets patients on 5 or more medications, their family members, and their primary care clinicians using a pragmatic, cluster-randomized design at Kaiser Permanente Colorado. The intervention has two components: a patient/ family component focused on education and activation about the potential value of deprescribing, and a clinician component focused on increasing clinician awareness about options and processes for deprescribing. Primary outcomes are total number of chronic medications and total number of potentially inappropriate medications (PIMs). We estimate that approximately 2400 patients across 9 clinics will receive the intervention. A comparable number of patients from 9 other clinics will serve as wait-list controls. We have > 80% power to detect an average decrease of - 0.70 (< 1 medication). Secondary outcomes include the number of PIM starts, dose reductions for selected PIMs (benzodiazepines, opiates, and antipsychotics), rates of adverse drug events (falls, hemorrhagic events, and hypoglycemic events), ability to perform activities of daily living, and skilled nursing facility, hospital, and emergency department admissions.
DISCUSSION
The OPTIMIZE trial will examine whether a primary care-based, patient- and family-centered intervention educating patients, family members, and clinicians about deprescribing reduces numbers of chronic medications and PIMs for older adults with dementia or MCI and MCC.
TRIAL REGISTRATION
NCT03984396. Registered on 13 June 2019.",2020,"The combination leads to multiple medications and complex medication regimens and is associated with increased risk for significant treatment burden, adverse drug events, cognitive changes, hospitalization, and mortality.","['approximately 2400 patients across 9 clinics will receive the intervention', 'older adults with dementia or mild cognitive impairment and multiple chronic conditions', 'individuals with dementia or mild cognitive impairment (MCI) have multiple chronic conditions (MCC', 'MCC patients with dementia or MCI', 'With input from patients, family members, and clinicians', 'The clinic-based intervention targets patients on 5 or more medications, their family members, and their primary care clinicians using a pragmatic, cluster-randomized design at Kaiser Permanente Colorado', 'older adults with dementia or MCI and MCC']","['primary care clinicians about deprescribing as part of optimal medication management', 'primary care-based deprescribing intervention']","['adverse drug events, cognitive changes, hospitalization, and mortality', 'number of PIM starts, dose reductions for selected PIMs (benzodiazepines, opiates, and antipsychotics), rates of adverse drug events (falls, hemorrhagic events, and hypoglycemic events), ability to perform activities of daily living, and skilled nursing facility, hospital, and emergency department admissions', 'total number of chronic medications and total number of potentially inappropriate medications (PIMs']","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0037265', 'cui_str': 'Skilled nursing facility'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.0361616,"The combination leads to multiple medications and complex medication regimens and is associated with increased risk for significant treatment burden, adverse drug events, cognitive changes, hospitalization, and mortality.","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Bayliss', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA. Elizabeth.Bayliss@kp.org.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Shetterly', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Drace', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Norton', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Green', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Reeve', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, UniSA: Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Weffald', 'Affiliation': 'Department of Clinical Pharmacy, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wright', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Maciejewski', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham, Veterans Affairs Medical Center, Durham, NC, USA.'}, {'ForeName': 'O C', 'Initials': 'OC', 'LastName': 'Sheehan', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Wolff', 'Affiliation': 'School of Public Health, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Gleason', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maiyani', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Du Vall', 'Affiliation': 'Department of Clinical Pharmacy, Kaiser Permanente Colorado, Aurora, CO, USA.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Boyd', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",Trials,['10.1186/s13063-020-04482-0']
1025,32550713,Ischemic preconditioning improves performance and accelerates the heart rate recovery.,"BACKGROUND
Previous studies have assessed the effects of ischemic preconditioning (IPC) on exercise performance and physiological variables, such as lactate and muscle deoxygenation. In this study, we verified the IPC effects on performance and heart rate during and immediately after a maximal incremental cycling test (ICT).
METHODS
Eighteen recreationally trained cyclists (28±4 years) were allocated to one of three groups: IPC, SHAM and Control. After the first visit to familiarization, cyclists attended the laboratory on two separate occasions to perform an ICT: in the 1st visit they performed the reference test (baseline), and in 2nd the test ischemic preconditioning (2 cycles of 5-min occlusion [at 50 mm Hg above systolic arterial pressure]/ 5-min reperfusion), SHAM (identical to ischemic preconditioning, but at 20 mm Hg) or control (no occlusion) interventions (post intervention). During the ICT, heart rate, power output and perceived exertion were measured and the heart rate was monitored throughout the recovery.
RESULTS
Only ischemic preconditioning group improved performance time by 4.9±4.0% and decreased heart rate at submaximal point during ICT, of 170±8 to 166±8 bpm (P<0.05). Also, IPC promoted faster heart rate recovery, mainly on first minute (from 151±9 to 145±8 bpm; P<0.05), compared to baseline. No differences for other parameters were found.
CONCLUSIONS
Two cycles of five minutes of ischemia were relevant to produce positive effects on performance and alter the heart rate during and soon after ICT.",2020,"Also, IPC promoted faster heart rate recovery, mainly on first minute (from 151 ± 9 to 145 ± 8 bpm; p<0.05), compared to baseline.",['Eighteen recreationally trained cyclists (28 ± 4 years'],"['ischemic preconditioning (IPC', 'IPC, SHAM and Control', 'Ischemic preconditioning', 'SHAM (identical to ischemic preconditioning, but at 20 mm Hg) or control (no occlusion) interventions', 'IPC']","['heart rate, power output and perceived exertion', 'performance time', 'heart rate', 'heart rate recovery', 'heart rate and performance']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",18.0,0.164322,"Also, IPC promoted faster heart rate recovery, mainly on first minute (from 151 ± 9 to 145 ± 8 bpm; p<0.05), compared to baseline.","[{'ForeName': 'Rhaí A', 'Initials': 'RA', 'LastName': 'Arriel', 'Affiliation': 'Department of Physiology, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Meireles', 'Affiliation': 'Department of Physiology, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Hohl', 'Affiliation': 'Department of Physiology, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Moacir', 'Initials': 'M', 'LastName': 'Marocolo', 'Affiliation': 'Department of Physiology, Federal University of Juiz de Fora, Juiz de Fora, Brazil - isamjf@gmail.com.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10822-3']
1026,32554999,Hip Resurfacing Compared with 28-mm Metal-on-Metal Total Hip Replacement: A Randomized Study with 15 Years of Follow-up.,"BACKGROUND
Bone stock conservation, hip anatomy preservation, and greater stability are among the promoted advantages of hip resurfacing (HR). However, the disappointing failure of some implants nearly led to its abandonment. The aim of this study was to compare clinical scores and revision and complication rates after HR with those after total hip arthroplasty (THA).
METHODS
Two hundred and three hips were randomized to 28-mm metal-on-metal (MoM) THA (99 hips) or to HR (104 hips). Main outcome measures compared between groups were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, the revision rate, and the complication rates. The radiographic findings were also assessed.
RESULTS
After a mean follow-up of 15 years (range, 14 to 16 years), 9 (4.4%) of the 203 patients were lost to follow-up and 15 (7.4%) had died. The Kaplan-Meier survivorship, with revision for any reason as the end point, was 89.2% (95% confidence interval [CI], 82.3% to 96.1%) for HR and 94.2% (95% CI, 89.3% to 99.1%) for THA (p = 0.292). The reasons for revision included infection (3 patients), recurrent dislocation (1 patient), and adverse reaction to metal debris (ARMD) (1 patient) in the THA group and ARMD (2 patients) and femoral head loosening (7 patients) in the HR group. With aseptic revision as the end point, the Kaplan-Meier survivorship was significantly higher in the THA group (97.4% versus 89.2%; p = 0.033). No dislocation occurred in the HR group compared with 4 in the THA group (p = 0.058). Both groups achieved a similar mean WOMAC score (10.7 in the HR group and 8.8 in the THA group; p = 0.749), Forgotten Joint Score (87.1 and 85.3, respectively; p = 0.410), University of California Los Angeles (UCLA) activity score (6.3 and 6.4, respectively; p = 0.189), and overall joint perception (p = 0.251).
CONCLUSIONS
The specific HR and MoM 28-mm THA implants used in this study showed good long-term survival and function. The overall rates of complications and revisions were similar in both groups but were of different types. As it provides better femoral bone preservation and biomechanical reconstruction, HR may continue to have a role in selected patients when performed by experienced surgeons and using validated implants.
LEVEL OF EVIDENCE
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"With aseptic revision as the end point, the Kaplan-Meier survivorship was significantly higher in the THA group (97.4% versus 89.2%; p = 0.033).","['Two hundred and three hips', '15 Years of Follow-up']","['THA', '28-mm metal-on-metal (MoM', '28-mm Metal-on-Metal Total Hip Replacement', 'Hip Resurfacing', 'total hip arthroplasty (THA']","['University of California Los Angeles (UCLA) activity score', 'overall rates of complications and revisions', 'mean WOMAC score', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, the revision rate, and the complication rates', 'recurrent dislocation (1 patient), and adverse reaction to metal debris (ARMD', 'Kaplan-Meier survivorship', 'clinical scores and revision and complication rates', 'died', 'good long-term survival and function', 'overall joint perception', 'Forgotten Joint Score', 'No dislocation']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}]","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0158100', 'cui_str': 'Recurrent dislocation of joint'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C4759288', 'cui_str': 'Forgotten Joint Score'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}]",203.0,0.128028,"With aseptic revision as the end point, the Kaplan-Meier survivorship was significantly higher in the THA group (97.4% versus 89.2%; p = 0.033).","[{'ForeName': 'Pascal-André', 'Initials': 'PA', 'LastName': 'Vendittoli', 'Affiliation': 'Surgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, Montréal, Québec, Canada.'}, {'ForeName': 'Maged', 'Initials': 'M', 'LastName': 'Shahin', 'Affiliation': 'Surgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, Montréal, Québec, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Rivière', 'Affiliation': 'MSK Lab-Imperial College London, London, United Kingdom.'}, {'ForeName': 'Alain Guy', 'Initials': 'AG', 'LastName': 'Roy', 'Affiliation': 'Surgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, Montréal, Québec, Canada.'}, {'ForeName': 'Janie', 'Initials': 'J', 'LastName': 'Barry', 'Affiliation': 'Surgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, Montréal, Québec, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lavigne', 'Affiliation': 'Surgery Department, Hôpital Maisonneuve-Rosemont, Montreal University, Montréal, Québec, Canada.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00030']
1027,32546045,The Effect of Ibuprofen Dosing Interval on Post-Tonsillectomy Outcomes in Children: A Quality Improvement Study.,"OBJECTIVE
In this Quality Improvement (QI project) it was hypothesized that an increase in dosing intervals for postoperative analgesia when alternating Ibuprofen and Acetaminophen would reduce post-tonsillectomy hemorrhage (PTH) rates for those undergoing tonsillectomies with or without adenoidectomy, while maintaining the standard of postoperative analgesia and reducing visits to the Emergency Room (ER) for reasons other than PTH. Data was collected from 353 children. Utilizing run chart analysis, it was determined that patients experiencing the 4-hour dosing interval had lower rates of PTH, fewer ER visits, and no increase in postoperative phone calls from caregivers.
PATIENTS AND METHODS
Patients were treated with standing Acetaminophen 15 mg/kg q6h and Ibuprofen 10 mg/kg q6h for postoperative analgesia from July of 2017 until January of 2018. Starting January of 2018 through November of 2018, the dosage interval was lengthened 1 hour. Data relating to PTH, ER visits for reasons other than bleeding, and phone calls from caregivers was collected.
RESULTS
Run charts were used to assess outcomes regarding PTH, postoperative visits to the ER for reasons other than PTH, and phone calls from caregivers. Our results suggest that a standing protocol of alternating Acetaminophen and Ibuprofen given every 4 hours improves the post-tonsillectomy hemorrhage rate without increasing ER visits or calls about pain.
CONCLUSIONS
This data shows promise in reducing PTH and ER visits with a longer dose interval when alternating Acetaminophen and Ibuprofen for postoperative analgesia in tonsillectomy patients. A randomized clinical trial should be carried out to further validate these claims.",2020,"Utilizing run chart analysis, it was determined that patients experiencing the 4-hour dosing interval had lower rates of PTH, fewer ER visits, and no increase in postoperative phone calls from caregivers.
","['Patients were treated with', 'Children', '353 children', 'tonsillectomy patients']","['Acetaminophen and Ibuprofen', 'standing Acetaminophen 15\u2009mg/kg q6h and Ibuprofen 10\u2009mg/kg q6h for postoperative analgesia', 'Ibuprofen and Acetaminophen', 'Ibuprofen']","['Quality Improvement (QI project', 'post-tonsillectomy hemorrhage (PTH) rates', 'rates of PTH, fewer ER visits', 'post-tonsillectomy hemorrhage rate', 'postoperative phone calls']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585325', 'cui_str': 'Every six hours'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",353.0,0.116173,"Utilizing run chart analysis, it was determined that patients experiencing the 4-hour dosing interval had lower rates of PTH, fewer ER visits, and no increase in postoperative phone calls from caregivers.
","[{'ForeName': 'Grayson', 'Initials': 'G', 'LastName': 'Mast', 'Affiliation': 'School of Medicine, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Krysta', 'Initials': 'K', 'LastName': 'Henderson', 'Affiliation': 'West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Michele M', 'Initials': 'MM', 'LastName': 'Carr', 'Affiliation': 'Department of Otolaryngology, University at Buffalo, Buffalo, NY, USA.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489420934843']
1028,32546128,Videolaryngoscopy versus direct laryngoscopy for double-lumen endotracheal tube intubation in thoracic surgery - a randomised controlled clinical trial.,"BACKGROUND
Double-lumen tube (DLT) intubation is necessary for thoracic surgery and other operations with the need for lung separation. However, DLT insertion is complex and might result in airway trauma. A new videolaryngoscopy (GVL) with a thin blade might improve the intubation time and reduce complexity as well as iatrogenic airway complications compared to conventional direct laryngoscopy (DL) for DLT intubation.
METHODS
A randomised, controlled trial was conducted in 70 patients undergoing elective thoracic surgery using DLT for lung separation. Primary endpoint was time to successful intubation. The secondary endpoints of this study were number of intubation attempts, the assessment of difficulty, any complications during DLT intubation and the incidence of objective trauma of the oropharynx and supraglottic space and intubation-related subjective symptoms.
RESULTS
65 patients were included (DL group [n = 31], GVL group [n = 34]). Median intubation time (25th-75th percentiles) in GVL group was 93 s (63-160) versus 74 (58-94) in DL group [p = 0.044]. GVL resulted in significantly improved visualisation of the larynx (Cormack and Lehane grade of 1 in GVL group was 97% vs. 74% in DL Group [p = 0.008]). Endoscopic examinations revealed significant differences in GVL group compared to DL group showing less red-blooded vocal cord [p = 0.004], vocal cord haematoma [p = 0.022] and vocal cord haemorrhage [p = 0.002]. No significant differences regarding the postoperative subjective symptoms of airway were found.
CONCLUSIONS
Videolaryngoscopy using the GlideScope®-Titanium shortly prolongs DLT intubation duration compared to direct laryngoscopy but improves the view. Objective intubation trauma but not subjective complaints are reduced.
TRIAL REGISTRATION
German Clinical Trial Register DRKS00020978, retrospectively registered on 09. March 2020.",2020,"Endoscopic examinations revealed significant differences in GVL group compared to DL group showing less red-blooded vocal cord [p = 0.004], vocal cord haematoma [p = 0.022] and vocal cord haemorrhage [p = 0.002].","['70 patients undergoing elective thoracic surgery using DLT for lung separation', '65 patients were included (DL group [n\u200a\u2009=\u2009\u200a31], GVL group [n\u200a\u2009=\u2009\u200a34']","['conventional direct laryngoscopy (DL', 'Double-lumen tube (DLT) intubation', 'Videolaryngoscopy versus direct laryngoscopy for double-lumen endotracheal tube intubation', 'videolaryngoscopy (GVL', 'GVL']","['postoperative subjective symptoms of airway', 'number of intubation attempts, the assessment of difficulty, any complications during DLT intubation and the incidence of objective trauma of the oropharynx and supraglottic space and intubation-related subjective symptoms', 'vocal cord haematoma', 'Median intubation time', 'DLT intubation duration', 'time to successful intubation', 'visualisation of the larynx (Cormack and Lehane grade', 'vocal cord haemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0441299', 'cui_str': 'Double lumen tube'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600554', 'cui_str': 'Graft-vs-Leukemia Effect'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}, {'cui': 'C0600554', 'cui_str': 'Graft-vs-Leukemia Effect'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441299', 'cui_str': 'Double lumen tube'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0225574', 'cui_str': 'Structure of supraglottic space'}, {'cui': 'C0344369', 'cui_str': 'Vocal cord hematoma'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0456719', 'cui_str': 'Cormack and Lehane grade'}]",70.0,0.326676,"Endoscopic examinations revealed significant differences in GVL group compared to DL group showing less red-blooded vocal cord [p = 0.004], vocal cord haematoma [p = 0.022] and vocal cord haemorrhage [p = 0.002].","[{'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Risse', 'Affiliation': 'Center of Emergency Medicine, University Hospital Essen, Hufelandstrasse 55, 45122, Essen, Germany. joachim.risse@uk-essen.de.'}, {'ForeName': 'Ann-Kristin', 'Initials': 'AK', 'LastName': 'Schubert', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg, Baldingerstraße, 35033, Marburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wiesmann', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg, Baldingerstraße, 35033, Marburg, Germany.'}, {'ForeName': 'Ansgar', 'Initials': 'A', 'LastName': 'Huelshoff', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg, Baldingerstraße, 35033, Marburg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stay', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg, Baldingerstraße, 35033, Marburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zentgraf', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg, Baldingerstraße, 35033, Marburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kirschbaum', 'Affiliation': 'Visceral, Thoracic and Vascular Surgery Clinic, University Hospital Giessen and Marburg GmbH, Baldingerstraße, 35033, Marburg, Germany.'}, {'ForeName': 'Hinnerk', 'Initials': 'H', 'LastName': 'Wulf', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg, Baldingerstraße, 35033, Marburg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Feldmann', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg, Baldingerstraße, 35033, Marburg, Germany.'}, {'ForeName': 'Karl Matteo', 'Initials': 'KM', 'LastName': 'Meggiolaro', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg, Baldingerstraße, 35033, Marburg, Germany.'}]",BMC anesthesiology,['10.1186/s12871-020-01067-x']
1029,32552828,Conversion of I-gel to definitive airway in a cervical immobilized manikin: Aintree intubation catheter vs long endotracheal tube.,"BACKGROUND
After prehospital insertion of i-gel, a popular supraglottic airway (SGA), fiberoptic-guided intubation through i-gel is often required to switch the i-gel to a definitive airway for anticipated difficult airway. The Aintree intubation catheter (AIC) was developed for this purpose yet it requires many procedural steps during which maintenance of adequate ventilation is difficult. We custom-made a long endotracheal tube (LET) which may facilitate this procedure and compared the efficacy of the AIC and LET in a cervical immobilized manikin.
METHODS
In this 2 × 2 crossover manikin-based trial, 20 anaesthesiologists and residents performed both methods in random order. Total intubation time, fiberoptic time, and procedure time were recorded. The ease of insertion, procedure failure rate, difficulty score, and participants' preference were recorded.
RESULTS
Total intubation time was significantly shorter for the LET than the AIC group (70.8 ± 16.4 s vs 94.0 ± 28.4 s, P = 0.001). The procedure time was significantly shorter in the LET group (51.9 ± 13.8 s vs 76.5 ± 25.4 s, P < 0.001). The ease of insertion score was lower, i.e., easier, in the AIC than the LET group (2.0 [1.0-2.75] vs 1.0 [1.0-1.0], P < 0.001). Fiberoptic time (19.0 ± 6.9 s vs 17.5 ± 12.3 s) and subjective difficulty (4.0 [3.0-6.0] vs 4.0 [3.0-5.75]) were similar between groups. Fourteen participants preferred the LET method (70%) due to its fewer procedural steps.
CONCLUSIONS
LET resulted in a shorter intubation time than the AIC during fiberoptic-guided intubation through the i-gel, possibly due to the less procedural steps compared to AIC.
TRIAL REGISTRATION
NCT03645174 (ClinicalTrials.gov, Aug 22, 2018).",2020,"RESULTS
Total intubation time was significantly shorter for the LET than the AIC group (70.8 ± 16.4 s vs 94.0 ± 28.4 s, P = 0.001).",[],"['custom-made a long endotracheal tube (LET', 'LET', 'Aintree intubation catheter (AIC']","['Fiberoptic time', 'procedure time', 'subjective difficulty', 'Total intubation time', 'shorter intubation time', 'ease of insertion score', 'Total intubation time, fiberoptic time, and procedure time']",[],"[{'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.129802,"RESULTS
Total intubation time was significantly shorter for the LET than the AIC group (70.8 ± 16.4 s vs 94.0 ± 28.4 s, P = 0.001).","[{'ForeName': 'Yun Jeong', 'Initials': 'YJ', 'LastName': 'Chae', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, South Korea.'}, {'ForeName': 'Heirim', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Office of Biostatics, Ajou Research Institute for Innovative Medicine, Ajou University Medical Center, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, South Korea.'}, {'ForeName': 'Bokyeong', 'Initials': 'B', 'LastName': 'Jun', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, South Korea.'}, {'ForeName': 'In Kyong', 'Initials': 'IK', 'LastName': 'Yi', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, South Korea. lyrin01@gmail.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01069-9']
1030,32556709,Comparing Effectiveness of HRV-Biofeedback and Mindfulness for Workplace Stress Reduction: A Randomized Controlled Trial.,"Psychophysiological disorders due to work-related stress continue to be highly costly for health systems and approaches for cost-effective and easily accessible interventions are much needed. Both heart rate variability-biofeedback (HRV-Bfb) and mindfulness-based interventions (MBI) have been empirically shown to reduce stress. This study compares these two interventions in the work context to a wait-list-control-group (WLC). In this three-armed randomized controlled trial (RCT), 69 healthy adults employed in the same organization were randomized to participate in HRV-Bfb, MBI or the WLC. Participants were assessed for psychophysiological parameters of stress (stress perception, coping, HRV parameters and cortisol) and stress related symptoms (depressive symptoms, psychological wellbeing, mindfulness and self-compassion). Participants trained using either HRV-Bfb or MBI for 6 weeks on a daily basis. Outcomes were assessed at baseline, after the intervention and at follow-up 12 weeks later. Results did not show any statistically significant differences between HRV-Bfb and MBI groups, and neither of the intervention groups (IGs) differed from the WLC. Findings suggest an overall reduction in stress for all groups, including the WLC, with mostly small to medium effect sizes. However, it is important to note that participants with higher baseline stress levels might benefit more from mindfulness and biofeedback-based stress reduction interventions. The results have to be interpreted with caution due to the relatively small sample size. MBI might have a slightly stronger effect on stress reduction in comparison to HRV-Bfb, as suggested by the effect sizes. This study highlights issues and challenges of the implementation of such interventions in corporate health management.",2020,"Findings suggest an overall reduction in stress for all groups, including the WLC, with mostly small to medium effect sizes.","['69 healthy adults employed in the same organization', 'Workplace Stress Reduction']","['HRV-Biofeedback and Mindfulness', 'HRV-Bfb, MBI or the WLC', 'HRV-Bfb or MBI', 'biofeedback (HRV-Bfb) and mindfulness-based interventions (MBI', 'wait-list-control-group (WLC']","['psychophysiological parameters of stress (stress perception, coping, HRV parameters and cortisol) and stress related symptoms (depressive symptoms, psychological wellbeing, mindfulness and self-compassion']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",69.0,0.0342822,"Findings suggest an overall reduction in stress for all groups, including the WLC, with mostly small to medium effect sizes.","[{'ForeName': 'Amelie Edith', 'Initials': 'AE', 'LastName': 'Brinkmann', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Tuebingen, 72070, Tübingen, Germany. amelie.brinkmann@uni-tuebingen.de.'}, {'ForeName': 'Sophia Antonia', 'Initials': 'SA', 'LastName': 'Press', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Tuebingen, 72070, Tübingen, Germany.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Helmert', 'Affiliation': 'ARCIM Institute for Academic Research in Complementary and Integrative Medicine, 70794, Filderstadt, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Tuebingen, 72070, Tübingen, Germany.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Khazan', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vagedes', 'Affiliation': 'ARCIM Institute for Academic Research in Complementary and Integrative Medicine, 70794, Filderstadt, Germany. j.vagedes@arcim-institute.de.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-020-09477-w']
1031,32573956,"Safety and Pharmacokinetics of High-Dose TAS-303 in Healthy Japanese Volunteers: A Single-Center, Single-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multiple-Ascending-Dose Study.","Preclinical data of TAS-303 (4-piperidinyl 2,2-diphenyl-2-[propoxy-1,1,2,2,3,3,3-d 7 ] acetate hydrochloride), a noradrenaline reuptake inhibitor, show that it increases urethral contraction in rats and may therefore benefit stress urinary incontinence patients. In this single-blind, randomized, placebo-controlled, parallel-group, multiple-ascending-dose phase 1 study, we evaluated the safety and tolerability of once-daily TAS-303 8, 10, 12, 15, or 18 mg administered for 16 days in healthy subjects. In addition, we investigated the pharmacokinetics and inhibitory effect of TAS-303 on hepatic cytochrome P450 (CYP) 3A activity. Rates of adverse events, adverse drug reactions, and pharmacokinetic parameters of TAS-303 were evaluated. Fifty subjects were randomized: 7 subjects each were assigned to receive TAS-303 8-18 mg, and 3 subjects each were assigned to receive placebo at each dose. The overall incidences of adverse events and adverse drug reactions in all subjects administered TAS-303 (n = 35) was 25.7% and 2.9%, respectively, and those for the placebo groups (n = 15) were 46.7% and 0%, respectively. No deaths or serious adverse events occurred. TAS-303 displayed a dose-proportional pharmacokinetic profile across doses of 8-18 mg over the 16-day multiple administration period, and TAS-303 might inhibit hepatic CYP3A activity within this dose range. TAS-303 at a dose of 8-18 mg was confirmed to be safe and tolerable.",2020,"The overall incidences of adverse events and adverse drug reactions in all subjects administered TAS-303 (n = 35) was 25.7% and 2.9%, respectively, and those for the placebo groups (n = 15) were 46.7% and 0%, respectively.","['healthy subjects', 'Healthy Japanese Volunteers', 'stress urinary incontinence patients', 'Fifty subjects were randomized: 7 subjects each']","['Placebo', 'TAS-303', 'TAS-303 (4-piperidinyl 2,2-diphenyl-2-[propoxy-1,1,2,2,3,3,3-d 7 ] acetate hydrochloride', 'High-Dose TAS-303', 'placebo']","['hepatic cytochrome P450 (CYP) 3A activity', 'deaths or serious adverse events', 'hepatic CYP3A activity', 'safety and tolerability', 'safe and tolerable', 'adverse events and adverse drug reactions', 'urethral contraction', 'Rates of adverse events, adverse drug reactions, and pharmacokinetic parameters of TAS-303', 'Safety and Pharmacokinetics']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}, {'cui': 'C0058372', 'cui_str': 'Diphenyl'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}]",50.0,0.251432,"The overall incidences of adverse events and adverse drug reactions in all subjects administered TAS-303 (n = 35) was 25.7% and 2.9%, respectively, and those for the placebo groups (n = 15) were 46.7% and 0%, respectively.","[{'ForeName': 'Ryuzo', 'Initials': 'R', 'LastName': 'Hanada', 'Affiliation': 'SOUSEIKAI Sumida Hospital, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.801']
1032,32546239,A prospective longitudinal study on the microbiota composition in amyotrophic lateral sclerosis.,"BACKGROUND
A connection between amyotrophic lateral sclerosis (ALS) and altered gut microbiota composition has previously been reported in animal models. This work is the first prospective longitudinal study addressing the microbiota composition in ALS patients and the impact of a probiotic supplementation on the gut microbiota and disease progression.
METHODS
Fifty patients and 50 matched controls were enrolled. The microbial profile of stool samples from patients and controls was analyzed via PCR-Denaturing Gradient Gel Electrophoresis, and the main microbial groups quantified via qPCR. The whole microbiota was then analyzed via next generation sequencing after amplification of the V3-V4 region of 16S rDNA. Patients were then randomized to receive probiotic treatment or placebo and followed up for 6 months with ALSFRS-R, BMI, and FVC%.
RESULTS
The results demonstrate that the gut microbiota of ALS patients is characterized by some differences with respect to controls, regardless of the disability degree. Moreover, the gut microbiota composition changes during the course of the disease as demonstrated by the significant decrease in the number of observed operational taxonomic unit during the follow-up. Interestingly, an unbalance between potentially protective microbial groups, such as Bacteroidetes, and other with potential neurotoxic or pro-inflammatory activity, such as Cyanobacteria, has been shown. The 6-month probiotic treatment influenced the gut microbial composition; however, it did not bring the biodiversity of intestinal microbiota of patients closer to that of control subjects and no influence on the progression of the disease measured by ALSFRS-R was demonstrated.
CONCLUSIONS
Our study poses the bases for larger clinical studies to characterize the microbiota changes as a novel ALS biomarker and to test new microbial strategy to ameliorate the health status of the gut.
TRIAL REGISTRATION
CE 107/14, approved by the Ethics Committee of the ""Maggiore della Carità"" University Hospital, Italy.",2020,"The 6-month probiotic treatment influenced the gut microbial composition; however, it did not bring the biodiversity of intestinal microbiota of patients closer to that of control subjects and no influence on the progression of the disease measured by ALSFRS-R was demonstrated.
","['Fifty patients and 50 matched controls were enrolled', 'amyotrophic lateral sclerosis', 'ALS patients']","['probiotic supplementation', 'probiotic treatment or placebo']","['gut microbial composition', 'gut microbiota composition changes', 'biodiversity of intestinal microbiota']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0282469', 'cui_str': 'Biological Diversity'}]",50.0,0.0171276,"The 6-month probiotic treatment influenced the gut microbial composition; however, it did not bring the biodiversity of intestinal microbiota of patients closer to that of control subjects and no influence on the progression of the disease measured by ALSFRS-R was demonstrated.
","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Di Gioia', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, Bologna, Italy.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bozzi Cionci', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, Bologna, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Baffoni', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, Bologna, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Amoruso', 'Affiliation': 'BIOLAB RESEARCH srl, via E. Mattei 3, 28100, Novara, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pane', 'Affiliation': 'BIOLAB RESEARCH srl, via E. Mattei 3, 28100, Novara, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Mogna', 'Affiliation': 'BIOLAB RESEARCH srl, via E. Mattei 3, 28100, Novara, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gaggìa', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, Bologna, Italy.'}, {'ForeName': 'Maria Ausiliatrice', 'Initials': 'MA', 'LastName': 'Lucenti', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Bersano', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cantello', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'De Marchi', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Mazzini', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy. letizia.mazzini@uniupo.it.'}]",BMC medicine,['10.1186/s12916-020-01607-9']
1033,32556710,Resolution of Hydronephrosis in Children with Dysfunctional Voiding After Biofeedback Therapy: A Randomized Clinical Trial.,"We assessed efficacy of biofeedback therapy and home pelvic floor muscle exercises in children with dysfunctional voiding (DV) associated with mild to moderate hydronephrosis. This prospective study comprised fifty seven children (21 boys, 36 girls; mean age 8.9 ± 2.6) with DV and mild to moderate hydronephrosis. Children were randomly allocated into two treatment groups including control group who underwent standard urotherapy and case group who received biofeedback therapy in addition to standard urotherapy. A 99mTc diethylenetriamine pentaacetic acid (99mDTPA) scan, voiding cystoureterography, kidney and bladder ultrasounds, voiding diary and uroflowmetry with electromyography (EMG) were performed in all study participants at the baseline. Children with evidence of complete obstruction in DTPA scan and vesicoureteral reflux were excluded from enrollment. A complete voiding diary, kidney and bladder ultrasounds and uroflowmetry/EMG were also performed 6 months and 1 year after completion of the treatment. We noted a more significant decline in anteroposterior pelvic diameter in case group compared to control group (P < 0.05). The mean maximal urine flow rate prior to treatment was 16.5 ± 2.6 and 16.1 ± 3 ml/s in case and control groups, respectively. This finding increased significantly 1 year after the treatment in case group compared to controls (25 ± 7.2 ml/s vs. 18.4 ± 5.9 ml/s, respectively; P < 0.001). Improvement of various parameters in voiding diary was also more significant in the case group. Biofeedback therapy can effectively resolve non-refluxing and non-obstructive hydronephrosis in children with DV.",2020,Biofeedback therapy can effectively resolve non-refluxing and non-obstructive hydronephrosis in children with DV.,"['Children with Dysfunctional Voiding', 'Children with evidence of complete obstruction in DTPA scan and vesicoureteral reflux', 'children with dysfunctional voiding (DV) associated with mild to moderate hydronephrosis', 'children with DV', 'fifty seven children (21 boys, 36 girls; mean age 8.9\u2009±\u20092.6) with DV and mild to moderate hydronephrosis']","['control group who underwent standard urotherapy and case group who received biofeedback therapy in addition to standard urotherapy', 'Biofeedback Therapy', 'Biofeedback therapy', 'biofeedback therapy and home pelvic floor muscle exercises']","['mean maximal urine flow rate', 'Resolution of Hydronephrosis', 'voiding diary', 'voiding diary, kidney and bladder ultrasounds and uroflowmetry/EMG', '99mTc diethylenetriamine pentaacetic acid (99mDTPA) scan, voiding cystoureterography, kidney and bladder ultrasounds, voiding diary and uroflowmetry with electromyography (EMG', 'anteroposterior pelvic diameter']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0403659', 'cui_str': 'Dysfunctional voiding'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0013254', 'cui_str': 'Pentetic acid'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0042580', 'cui_str': 'Vesicoureteric reflux'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517633', 'cui_str': '2.6'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0855956', 'cui_str': 'Ultrasound bladder'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1692878', 'cui_str': '99mTc(HYNICtide)(tricine)(TPPTS)'}, {'cui': 'C0013254', 'cui_str': 'Pentetic acid'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",57.0,0.0344376,Biofeedback therapy can effectively resolve non-refluxing and non-obstructive hydronephrosis in children with DV.,"[{'ForeName': 'Seyedeh-Sanam', 'Initials': 'SS', 'LastName': 'Ladi-Seyedian', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, No. 62, Dr. Qarib St, Keshavarz Blvd, 4194 33151, Tehran, Iran.""}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Sharifi-Rad', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, No. 62, Dr. Qarib St, Keshavarz Blvd, 4194 33151, Tehran, Iran.""}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Amini', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, No. 62, Dr. Qarib St, Keshavarz Blvd, 4194 33151, Tehran, Iran.""}, {'ForeName': 'Abdol-Mohammad', 'Initials': 'AM', 'LastName': 'Kajbafzadeh', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, No. 62, Dr. Qarib St, Keshavarz Blvd, 4194 33151, Tehran, Iran. kajbafzd@sina.tums.ac.ir.""}]",Applied psychophysiology and biofeedback,['10.1007/s10484-020-09474-z']
1034,32554291,Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial.,"OBJECTIVES
Pregnancy hypertension is associated with 7.1% of maternal deaths in India. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.
STUDY DESIGN
The Indian Community-Level Interventions for Pre-eclampsia (CLIP) open-label cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka. The CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4 h) or non-urgently (<24 h), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of mHealth-guided CHW-provided contacts.
MAIN OUTCOME MEASURES
20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.
RESULTS
All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up. The primary outcome did not differ between intervention and control arms (adjusted odds ratio (aOR) 0.92 [95% confidence interval 0.74, 1.15]; p = 0.47; intraclass correlation coefficient 0.013). There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals. Compared with intervention arm women without CLIP contacts, those with ≥8 contacts suffered fewer stillbirths (aOR 0.19 [0.10, 0.35]; p < 0.001), at the probable expense of survivable neonatal morbidity (aOR 1.39 [0.97, 1.99]; p = 0.072).
CONCLUSIONS
As implemented, solely community-level interventions focussed on pre-eclampsia did not improve outcomes in northwest Karnataka.",2020,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","['All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up', 'pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka', 'pre-eclampsia (CLIP) in India']","['CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4\xa0h) or non-urgently', 'task-sharing care', 'Community level interventions', 'methyldopa']","['safety and evaluation of the intensity of mHealth-guided CHW-provided contacts', 'survivable neonatal morbidity', 'composite of maternal, fetal, and newborn mortality and major morbidity']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0025741', 'cui_str': 'Methyldopa'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.32665,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","[{'ForeName': 'Mrutunjaya B', 'Initials': 'MB', 'LastName': 'Bellad', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India. Electronic address: mbbellad@hotmail.com.""}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Ashalata A', 'Initials': 'AA', 'LastName': 'Mallapur', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Umesh S', 'Initials': 'US', 'LastName': 'Charantimath', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Geetanjali M', 'Initials': 'GM', 'LastName': 'Katageri', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Umesh Y', 'Initials': 'UY', 'LastName': 'Ramadurg', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Global Affairs, 1020 Walnut Street, Thomas Jefferson University, Philadelphia 19107, USA.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Narayan V', 'Initials': 'NV', 'LastName': 'Honnungar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Chandrashekhar', 'Initials': 'C', 'LastName': 'Karadiguddi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Avinash J', 'Initials': 'AJ', 'LastName': 'Kavi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Bhalachandra S', 'Initials': 'BS', 'LastName': 'Kodkany', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Amit P', 'Initials': 'AP', 'LastName': 'Revankar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada; Aga Khan University, Stadium Road, P.O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.008']
1035,32584168,"The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study. A Randomized, Double-Blind, Multicenter Clinical Trial.","Rationale: In the IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial, fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) significantly reduced exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations. Objectives: To understand whether inhaled corticosteroid (ICS) withdrawal affected IMPACT results, given direct transition from prior maintenance medication to study medication at randomization. Methods: Exacerbations and change from baseline in trough FEV 1 and St. George's Respiratory Questionnaire results were analyzed by prior ICS use. Exacerbations were also analyzed while excluding data from the first 30 days. Measurements and Main Results: FF/UMEC/VI significantly reduced the annual moderate/severe exacerbation rate compared with UMEC/VI in prior ICS users (29% reduction; P < 0.001), but only a numerical reduction was seen among prior ICS nonusers (12% reduction; P = 0.115). To minimize impact from ICS withdrawal, in an analysis excluding the first 30 days, FF/UMEC/VI continued to significantly reduce the annual on-treatment moderate/severe exacerbation rate (19%; P < 0.001) compared with UMEC/VI. The benefit of FF/UMEC/VI compared with UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users, 35% reduction; P < 0.001; non-ICS users, 35% reduction; P = 0.018), and overall when excluding the first 30 days (29%; P < 0.001). Improvements from baseline with FF/UMEC/VI compared with UMEC/VI were also maintained throughout the study for both trough FEV 1 and St. George's Respiratory Questionnaire, regardless of prior ICS use. Conclusions: These data support the important treatment effects of FF/UMEC/VI combination therapy on exacerbation reduction, lung function, and quality of life that do not appear to be related to abrupt ICS withdrawal.Clinical trial registered with www.clinicaltrials.gov (NCT02164513).",2020,"Benefit of FF/UMEC/VI versus UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users: 35% reduction, p<0.001; non-ICS users: 35% reduction, p=0.018) and overall when excluding the first 30 days (29%, p<0.001).",['patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations'],"['inhaled corticosteroid (ICS', 'FF/UMEC/VI versus UMEC', 'fluticasone furoate/umeclidinium/ vilanterol (FF/UMEC/VI', 'ICS Withdrawal and Baseline Inhaled Treatment']","['severe exacerbation rates', ""trough forced expiratory volume in 1 second (FEV 1 ) and St George's Respiratory Questionnaire (SGRQ"", 'annual moderate/severe exacerbation rate', 'exacerbation reduction, lung function and quality of life', 'severe exacerbation rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.74081,"Benefit of FF/UMEC/VI versus UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users: 35% reduction, p<0.001; non-ICS users: 35% reduction, p=0.018) and overall when excluding the first 30 days (29%, p<0.001).","[{'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Pulmonary and Critical Care Medicine, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'Development, Research and Development, and.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline, Collegeville, Pennsylvania.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lettis', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline, Collegeville, Pennsylvania.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'Medical Department, Pulmonary Section, Herlev-Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'Global Medical Affairs, GlaxoSmithKline, Brentford, Middlesex, United Kingdom.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom; and.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201912-2478OC']
1036,32579811,Effects of Allopurinol on the Progression of Chronic Kidney Disease.,"BACKGROUND
Elevated serum urate levels are associated with progression of chronic kidney disease. Whether urate-lowering treatment with allopurinol can attenuate the decline of the estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease who are at risk for progression is not known.
METHODS
In this randomized, controlled trial, we randomly assigned adults with stage 3 or 4 chronic kidney disease and no history of gout who had a urinary albumin:creatinine ratio of 265 or higher (with albumin measured in milligrams and creatinine in grams) or an eGFR decrease of at least 3.0 ml per minute per 1.73 m 2 of body-surface area in the preceding year to receive allopurinol (100 to 300 mg daily) or placebo. The primary outcome was the change in eGFR from randomization to week 104, calculated with the Chronic Kidney Disease Epidemiology Collaboration creatinine equation.
RESULTS
Enrollment was stopped because of slow recruitment after 369 of 620 intended patients were randomly assigned to receive allopurinol (185 patients) or placebo (184 patients). Three patients per group withdrew immediately after randomization. The remaining 363 patients (mean eGFR, 31.7 ml per minute per 1.73 m 2 ; median urine albumin:creatinine ratio, 716.9; mean serum urate level, 8.2 mg per deciliter) were included in the assessment of the primary outcome. The change in eGFR did not differ significantly between the allopurinol group and the placebo group (-3.33 ml per minute per 1.73 m 2 per year [95% confidence interval {CI}, -4.11 to -2.55] and -3.23 ml per minute per 1.73 m 2 per year [95% CI, -3.98 to -2.47], respectively; mean difference, -0.10 ml per minute per 1.73 m 2 per year [95% CI, -1.18 to 0.97]; P = 0.85). Serious adverse events were reported in 84 of 182 patients (46%) in the allopurinol group and in 79 of 181 patients (44%) in the placebo group.
CONCLUSIONS
In patients with chronic kidney disease and a high risk of progression, urate-lowering treatment with allopurinol did not slow the decline in eGFR as compared with placebo. (Funded by the National Health and Medical Research Council of Australia and the Health Research Council of New Zealand; CKD-FIX Australian New Zealand Clinical Trials Registry number, ACTRN12611000791932.).",2020,"The change in eGFR did not differ significantly between the allopurinol group and the placebo group (-3.33 ml per minute per 1.73 m 2 per year [95% confidence interval {CI}, -4.11 to -2.55] and","['patients with chronic kidney disease who are at risk for progression is not known', 'patients with chronic kidney disease and a high risk of progression, urate-lowering treatment with', 'The remaining 363 patients (mean eGFR, 31.7 ml per minute per 1.73 m 2 ; median urine albumin:creatinine ratio, 716.9; mean serum urate level, 8.2 mg per deciliter', 'Enrollment was stopped because of slow recruitment after 369 of 620 intended patients', 'randomly assigned adults with stage 3 or 4 chronic kidney disease and no history of gout who had a urinary albumin:creatinine ratio of 265 or higher (with albumin measured in milligrams and creatinine in grams) or an eGFR decrease of at least 3.0 ml per minute per 1.73 m 2 of body-surface area in the preceding year to receive']","['placebo', 'allopurinol', 'Allopurinol']","['Chronic Kidney Disease Epidemiology Collaboration creatinine equation', 'glomerular filtration rate (eGFR', 'change in eGFR', 'Progression of Chronic Kidney Disease', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439673', 'cui_str': 'Unknown'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C4708784', 'cui_str': '31.7'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0439241', 'cui_str': 'dL'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C4552444', 'cui_str': 'Estimated glomerular filtration rate decreased'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",620.0,0.744268,"The change in eGFR did not differ significantly between the allopurinol group and the placebo group (-3.33 ml per minute per 1.73 m 2 per year [95% confidence interval {CI}, -4.11 to -2.55] and","[{'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Badve', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Pascoe', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Anushree', 'Initials': 'A', 'LastName': 'Tiku', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Boudville', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Fiona G', 'Initials': 'FG', 'LastName': 'Brown', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cass', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dalbeth', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Richard O', 'Initials': 'RO', 'LastName': 'Day', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Janak R', 'Initials': 'JR', 'LastName': 'de Zoysa', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Douglas', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Faull', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Harris', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Graham R D', 'Initials': 'GRD', 'LastName': 'Jones', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kanellis', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Suetonia C', 'Initials': 'SC', 'LastName': 'Palmer', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Gopala K', 'Initials': 'GK', 'LastName': 'Rangan', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reidlinger', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Robison', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Walker', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Walters', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': ""From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915833']
1037,32470710,Adjuvant therapy with pegylated interferon-alfa2b vs observation in stage II B/C patients with ulcerated primary: Results of the European Organisation for Research and Treatment of Cancer 18081 randomised trial.,"BACKGROUND
Subgroup analyses of two large EORTC adjuvant interferon-alpha2b (IFNα-2b) vs observation randomised trials demonstrated that a treatment benefit was observed only in patients with an ulcerated melanoma without palpable nodes (hazard ratio [HR] for recurrence-free survival [RFS] was 0.69). This was confirmed by a meta-analysis of 15 adjuvant IFN trials (HR: 0.79).
PATIENTS AND METHODS
In the EORTC 18081 trial, sentinel node-negative stage II patients with an ulcerated primary melanoma were 1:1 randomised between pegylated (PEG)-IFNα-2b at 3 μg/kg/week subcutaneously and observation, for 2 years, or until disease recurrence or unacceptable toxicity in spite of dose adjustments to maintain an Eastern Cooperative Oncology Group performance status of 0 or 1. Main end-point was RFS. Secondary end-points included distant metastasis-free survival (DMFS), overall survival, and safety (EudraCT Number: 2009-010273-20).
RESULTS
Between February 2013 and January 2017, only 112 patients were randomised, 56 in each arm. The trial was stopped early for lack of recruitment. At a 3.4-year median follow-up, the estimated HR for the PEG-IFNα-2b group compared with the observation group regarding RFS was 0.66 (95% confidence interval [CI]: 0.32-1.37), and the 3-year RFS rate was 80.0% (95% CI: 65.7-88.8%) and 72.9% (95% CI: 58.3-83.0%), respectively. DMFS was prolonged: HR: 0.39 (95% CI: 0.15-0.97), and the 3-year DMFS rate was 90.6% (95% CI: 78.9-96.0%) vs 76.4% (95% CI: 62.1-85.9%). One patient in the PEG-IFNα-2b group died compared with 4 in the observation group. Fifty-four patients started PEG-IFNα-2b treatment, 16 (29%) completed 2 years of treatment, 2 (4%) stopped due to recurrence, 23 (43%) due to toxicity and 14 (25%) due to other reasons.
CONCLUSIONS
The EORTC 18081 PEG-IFNα-2b randomised trial, observed a similar HR (0.69) for RFS as the previous EORTC trials (0.69). In countries without access to new drugs, adjuvant (PEG)-IFNα-2b treatment is an option for patients with ulcerated melanomas without palpable nodes.",2020,"At a 3.4-year median follow-up, the estimated HR for the PEG-IFNα-2b group compared with the observation group regarding RFS was 0.66 (95% confidence interval [CI]: 0.32-1.37), and the 3-year RFS rate was 80.0% (95% CI: 65.7-88.8%) and 72.9% (95% CI: 58.3-83.0%), respectively.","['only 112 patients were randomised, 56 in each arm', 'stage II B/C patients with ulcerated primary', 'sentinel node-negative stage II patients with an ulcerated primary melanoma', 'patients with ulcerated melanomas without palpable nodes', 'Between February 2013 and January 2017']","['adjuvant (PEG)-IFNα-2b treatment', 'pegylated interferon-alfa2b vs observation', 'pegylated (PEG)-IFNα-2b']","['distant metastasis-free survival (DMFS), overall survival, and safety (EudraCT Number: 2009-010273-20', '3-year RFS rate', 'DMFS', 'toxicity', '3-year DMFS rate']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0522499', 'cui_str': 'Palpable'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.689158,"At a 3.4-year median follow-up, the estimated HR for the PEG-IFNα-2b group compared with the observation group regarding RFS was 0.66 (95% confidence interval [CI]: 0.32-1.37), and the 3-year RFS rate was 80.0% (95% CI: 65.7-88.8%) and 72.9% (95% CI: 58.3-83.0%), respectively.","[{'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Prinses Maxima Centrum, Utrecht, the Netherlands. Electronic address: alexander.eggermont@prinsesmaximacentrum.nl.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland. Electronic address: piotr.rutkowski@pib-nio.pl.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'CHU de Bordeaux, Groupe Hospitalier Saint-André, Hopital Saint-André, Bordeaux, France. Electronic address: caroline.dutriaux@chu-bordeaux.fr.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Hofman-Wellenhof', 'Affiliation': 'Medical University of Graz, Graz, Austria. Electronic address: rainer.hofmann@medunigraz.at.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dziewulski', 'Affiliation': 'Mid Essex Hospitals, Broomfield Hospital, Broomfield, United Kingdom. Electronic address: peter.dziewulski@meht.nhs.uk.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Marples', 'Affiliation': ""Leeds Teaching Hospitals NHS Trust, St. James's University Hospital, Leeds, United Kingdom. Electronic address: maria.marples@nhs.net.""}, {'ForeName': 'Floren', 'Initials': 'F', 'LastName': 'Grange', 'Affiliation': 'CHU de Reims, Hôpital Robert Debré, Reims, France. Electronic address: fgrange@chu-reims.fr.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lok', 'Affiliation': 'CHU Amiens, Hopital Sud, Amiens, France. Electronic address: lok.catherine@chu-amiens.fr.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Pennachioli', 'Affiliation': 'Istituto Europeo di Oncologia, Milan, Italy. Electronic address: elisabetta.pennacchioli@ieo.it.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy, Villejuif & Paris-Saclay University, Saint-Aubin, France. Electronic address: caroline.robert@gustaveroussy.fr.'}, {'ForeName': 'Alexander C J', 'Initials': 'ACJ', 'LastName': 'van Akkooi', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands. Electronic address: a.v.akkooi@nki.nl.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': 'Odense University Hospital, Odense, Denmark. Electronic address: lars.bastholt@rsyd.dk.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Minisini', 'Affiliation': 'Azienda Sanitaria Universitaria Del Friuli Centrale, Udine, Italy. Electronic address: alessandro.minisini@asufc.sanita.fvg.it.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Marshall', 'Affiliation': 'St Helens & Knowsley NHS Trust, Whiston Hospital, Prescot, United Kingdom. Electronic address: emarshall@nhs.net.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Salès', 'Affiliation': 'Institut Jules Bordet-Hopital Universitaire ULB, Brussels, Belgium. Electronic address: fsales@bordet.be.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Assistance Publique, Hopitaux de Marseille, Hôpital de La Timone (APHM), Marseille, France. Electronic address: jean-jacques.grob@ap-hm.fr.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bechter', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Campus Gasthuisberg, Leuven, Belgium. Electronic address: oliver.bechter@uzleuven.be.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen & German Cancer Consortium, Heidelberg, Germany. Electronic address: dirk.schadendorf@uk-essen.de.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: sandrine.marreaud@eortc.org.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: michal.kicinski@eortc.org.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium. Electronic address: stefan.suciu@eortc.org.'}, {'ForeName': 'Alessandro A E', 'Initials': 'AAE', 'LastName': 'Testori', 'Affiliation': 'Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. Electronic address: A.Testori@smatteo.pv.it.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.015']
1038,32544067,The effect of hole size on failure loads of the distal humerus fenestration in Outerbridge-Kashiwagi arthroplasty: A biomechanical study.,"OBJECTIVE
The aim of this study was to biomechanically assess the effect of humeral-fenestration size in the Outerbridge-Kashiwagi arthroplasty on the ultimate failure load of the distal humerus in a synthetic bone model.
METHODS
We biomechanically tested the influence of different humeral-fenestration sizes on the failure load of the distal humerus in Outerbridge-Kashiwagi arthroplasty. A total of 50 synthetic humerus models were divided into 5 groups based on the fenestration size: 10 mm, 12 mm, 15 mm, 18 mm, and 20 mm. All the samples were randomly assigned to receive either axial or anteroposterior (AP) loading and then loaded to failure at a rate of 2 mm/min on a material testing machine. The data regarding ultimate failure loads under the axial and AP loading were analyzed.
RESULTS
Under the AP loading, the mean ultimate failure loads of the 18 mm and 20 mm groups were lower than those of the other groups. Under the axial loading, the mean ultimate failure load of the 10 mm group was significantly greater than that of the 15 mm, 18 mm, and 20 mm groups. Additionally, the ultimate failure load of the 20 mm group was significantly lower than that of the 12 mm, 15 mm, and 18 mm groups.
CONCLUSION
The distal humeral fenestrations with a size greater than 18 mm may offer poor biomechanical properties in the Outerbridge-Kashiwagi ulnohumeral arthroplasty.",2020,"Under the AP loading, the mean ultimate failure loads of the 18 mm and 20 mm groups were lower than those of the other groups.","['50 synthetic humerus models', 'Outerbridge-Kashiwagi arthroplasty']","['hole size', 'axial or anteroposterior (AP) loading']","['mean ultimate failure loads', 'ultimate failure load']","[{'cui': 'C0020164', 'cui_str': 'Bone structure of humerus'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]","[{'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205131', 'cui_str': 'Axial'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",50.0,0.0468683,"Under the AP loading, the mean ultimate failure loads of the 18 mm and 20 mm groups were lower than those of the other groups.","[{'ForeName': 'Chih-Kai', 'Initials': 'CK', 'LastName': 'Hong', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, School of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Kai-Lan', 'Initials': 'KL', 'LastName': 'Hsu', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, School of Medicine, National Cheng Kung University, Tainan, Taiwan;Department of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Fa-Chuan', 'Initials': 'FC', 'LastName': 'Kuan', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, School of Medicine, National Cheng Kung University, Tainan, Taiwan;Department of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Chi-Hsiu', 'Initials': 'CH', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, National Cheng Kung University Hospital, School of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Ping-Hui', 'Initials': 'PH', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Chi-Mei Medical Center, Tainan, Taiwan.'}, {'ForeName': 'Wei-Ren', 'Initials': 'WR', 'LastName': 'Su', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan;Skeleton Materials and Bio-compatibility Core Lab, Research Center of Clinical Medicine, National Cheng Kung University Hospital, College of Medicine,National Cheng Kung University, Tainan, Taiwan.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.03.59']
1039,32554067,Dexmedetomidine Provides Fewer Respiratory Events Compared With Propofol and Fentanyl During Third Molar Surgery: A Randomized Clinical Trial.,"PURPOSE
Propofol and fentanyl can cause airway obstruction and respiratory depression when used together for intravenous sedation. This study investigated whether dexmedetomidine and midazolam would decrease respiratory events requiring intervention during deep sedation compared with propofol, fentanyl, and midazolam.
PATIENTS AND METHODS
A prospective, randomized, double-blinded, controlled trial was designed to assess 2 intravenous treatment groups during third molar surgery. Patients were randomized into 2 groups. The control group (group P) received 0.8 μg/kg of fentanyl followed by propofol infusion at 125 μg/kg per minute over a 10-minute period with intraoperative boluses of 0.1 μg/kg. The study group (group D) received dexmedetomidine bolus infusion of 1 μg/kg over a 10-minute period followed by maintenance infusion at 0.5 μg/kg per hour. Both groups were given 0.03 mg/kg of midazolam before infusion. Scorers, masked to group, viewed the procedure remotely and evaluated the primary outcome variable of respiratory events requiring intervention. Secondary outcome variables evaluated by the scorers included the Behavioral Pain Scale for non-intubated patients at initial injection, cooperation score at 5 and 15 minutes, and time to ambulation and discharge. Patient satisfaction and hemodynamic stability were measured. The difference between groups regarding the occurrence of respiratory events was tested using the Fisher exact test, and mixed-effects models were used to compare repeated vital signs.
RESULTS
The sample was composed of 141 patients randomly assigned to either group P (n = 67) or group D (n = 74). No statistically significant differences in the distribution of study variables were found between groups at baseline. A statistically significant difference in respiratory events requiring deliberate intervention existed between group P (25.4%) and group D (2.7%) (P < .0001). No statistically significant difference was found between groups for Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction.
CONCLUSIONS
Using dexmedetomidine and midazolam for outpatient surgery resulted in fewer respiratory events requiring deliberate intervention compared with propofol, fentanyl, and midazolam. Ambulation and discharge times were not prolonged using dexmedetomidine.",2020,"No statistically significant difference was found between groups for Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction.
",['141 patients randomly assigned to either group P (n\xa0=\xa067) or group D'],"['dexmedetomidine bolus infusion of 1\xa0μg/kg over a 10-minute period followed by maintenance infusion', 'Dexmedetomidine', 'Propofol and Fentanyl', 'Propofol and fentanyl', 'fentanyl followed by propofol infusion', 'propofol, fentanyl, and midazolam', 'dexmedetomidine and midazolam', 'midazolam', 'dexmedetomidine']","['occurrence of respiratory events', 'Respiratory Events', 'respiratory events', 'Patient satisfaction and hemodynamic stability', 'Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction', 'Behavioral Pain Scale for non-intubated patients at initial injection, cooperation score at 5 and 15\xa0minutes, and time to ambulation and discharge', 'Ambulation and discharge times']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441849', 'cui_str': 'Group P'}, {'cui': 'C0441838', 'cui_str': 'Group D'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}]",141.0,0.396816,"No statistically significant difference was found between groups for Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction.
","[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Nolan', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY. Electronic address: PNOLAN@montefiore.org.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Delgadillo', 'Affiliation': 'Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Youssef', 'Affiliation': 'Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Freeman', 'Affiliation': 'Professor of Biomedical Science, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Former Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Chehrehsa', 'Affiliation': 'Former Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.015']
1040,32554068,Does the Low-Intensity Laser Protocol Affect Tissue Healing After Third Molar Removal?,"PURPOSE
Studies have shown that laser therapy is a recommended therapy for improving the postoperative period in patients undergoing extraction of the third molars; however, there is still no definition regarding the best protocol to be used. The aim of this study was to measure and compare periodontal tissue healing using 2 different laser protocols.
MATERIALS AND METHODS
A double-blinded, randomized, prospective study with patients submitted to inferior third molar extraction was performed, with the sample divided into 3 groups according to the laser application protocol and followed for 6 months: group I, 10 J/cm 2 ; group II, 30 J/cm 2 ; and group III, sham. The primary variable was probing depth, and the secondary variables were trismus, facial edema, and pain.
RESULTS
The sample was composed of 57 patients: 19 in group I, 20 in group II, and 18 in group III. Analysis of the variables showed statistically significant differences between both groups that received laser therapy, with values of 1.46 for edema control on the third day and 0.54 on the seventh day in group I (P = .017) and 1.26 and 0.52, respectively, in group II (P = .001) compared with 0.59 and 0.49, respectively, in the sham group (P = .702), as well as a statistically significant difference for the 10-J/cm 2 laser protocol for probing depth, with values of 7.58 mm preoperatively and 9.09 mm after 6 months (P = .013).
CONCLUSIONS
The use of the low-intensity laser as adjuvant therapy after third molar extraction was more effective in the group undergoing the 10-J/cm 2 laser protocol for improving periodontal tissue healing and in both laser therapy groups for reducing facial edema.",2020,"Analysis of the variables showed statistically significant differences between both groups that received laser therapy, with values of 1.46 for edema control on the third day and 0.54 on the seventh day in group","['patients submitted to inferior third molar extraction', 'patients undergoing extraction of the third molars']","['laser therapy', 'low-intensity laser']","['periodontal tissue healing', 'facial edema', 'trismus, facial edema, and pain', 'Tissue Healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C3873737', 'cui_str': 'Low-intensity laser'}]","[{'cui': 'C0031104', 'cui_str': 'Structure of gum and supporting structure of tooth'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0542571', 'cui_str': 'Edema of face'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",57.0,0.0358131,"Analysis of the variables showed statistically significant differences between both groups that received laser therapy, with values of 1.46 for edema control on the third day and 0.54 on the seventh day in group","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Bianchi de Moraes', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil.'}, {'ForeName': 'Rúbia', 'Initials': 'R', 'LastName': 'Gomes de Oliveira', 'Affiliation': 'MS Student, Oral and Maxillofacial Surgery Area, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil.'}, {'ForeName': 'Fernando Vagner', 'Initials': 'FV', 'LastName': 'Raldi', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil.'}, {'ForeName': 'Rodrigo Dias', 'Initials': 'RD', 'LastName': 'Nascimento', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil.'}, {'ForeName': 'Mauro Pedrine', 'Initials': 'MP', 'LastName': 'Santamaria', 'Affiliation': 'Assistant Professor, Division of Periodontics, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil.'}, {'ForeName': 'Fábio Ricardo', 'Initials': 'FR', 'LastName': 'Loureiro Sato', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Diagnosis and Surgery, State University of São Paulo (UNESP), College of Dentistry, São José dos Campos, Brazil. Electronic address: fabio.sato@ict.unesp.br.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.018']
1041,32569854,Improving imagery rescripting treatments: Comparing an active versus passive approach.,"BACKGROUND AND OBJECTIVES
In imagery rescripting (ImRs), aversive mental images are modified to reduce symptoms in a variety of psychological disorders. However, uniform guidelines on how to optimally implement ImRs do currently not exist. It remains unclear whether therapists should stimulate patients to imagine themselves to actively intervene within the new image, or whether they may imagine helpers to change the situation. We aimed to compare these two variants of ImRs within an analogue experimental setting.
METHODS
After having watched an aversive film, one-hundred participants were randomly assigned to active ImRs (ImRs-A), passive ImRs (ImRs-P), imagery rehearsal (IRE), or no-intervention control (NIC). Participants were either instructed to rescript the film by imagining themselves intervening in the new script (ImRs-A) or encouraged to imagine helpers to intervene in the imagined situation (ImRs-P).
RESULTS
Both ImRs increased mastery and elicited less distress than IRE with ImRs-P being experienced as less distressing than ImRs-A. Only ImRs-A led to a stronger increase in positive affect than IRE, whereas groups did not differ with respect to negative affect and self-efficacy. Conditions did not differ regarding the number of film-related intrusive memories.
LIMITATIONS
As a convenience sample was investigated, results cannot be generalized to clinical samples.
CONCLUSION
Even though differences regarding symptomatic outcome could not be detected, ImRs-P was experienced as less distressing than ImRs-A. Results suggest that both ImRs lead to different processes during the intervention than mere exposure. Compared to IRE, ImRs increases mastery with ImRs-A and ImRs-P being equally effective.",2020,"Both ImRs increased mastery and elicited less distress than IRE with ImRs-P being experienced as less distressing than ImRs-A. Only ImRs-A led to a stronger increase in positive affect than IRE, whereas groups did not differ with respect to negative affect and self-efficacy.","['After having watched an aversive film, one-hundred participants']","['active ImRs (ImRs-A), passive ImRs (ImRs-P), imagery rehearsal (IRE), or no-intervention control (NIC', 'instructed to rescript the film by imagining themselves intervening in the new script (ImRs-A) or encouraged to imagine helpers to intervene in the imagined situation (ImRs-P']",['number of film-related intrusive memories'],"[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1704608', 'cui_str': 'Film'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories'}]",100.0,0.0317839,"Both ImRs increased mastery and elicited less distress than IRE with ImRs-P being experienced as less distressing than ImRs-A. Only ImRs-A led to a stronger increase in positive affect than IRE, whereas groups did not differ with respect to negative affect and self-efficacy.","[{'ForeName': 'Marena', 'Initials': 'M', 'LastName': 'Siegesleitner', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Strohm', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Wittekind', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ehring', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Kunze', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany. Electronic address: anna.kunze@psy.lmu.de.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101578']
1042,32575919,Gamification in Physical Education: Evaluation of Impact on Motivation and Academic Performance within Higher Education.,"Gamification is an innovative pedagogical approach to addressing problems related to social behaviour, student motivation and academic performance at different educational stages. Therefore, this research aimed to analyse its impact on the motivations and academic performances of university students. The research was carried out in the training of future teachers specialising in physical education during two academic courses. In total, 127 students participated in the study, divided into a gamified experimental group ( n = 62) and a control group ( n = 65). The participants completed a questionnaire to assess motivation in physical education before and after the intervention and performed a final exam to assess academic performance. The results indicated an increase in external regulation in the experimental group only. Furthermore, this group achieved significantly better academic performance. The findings of this study suggest that gamified implementation is beneficial for academic performance at the university stage, even though intrinsic motivation does not change. Furthermore, the nature of rewards or punishments, as characteristic of this pedagogical approach, could play an important role in the expected results, since external regulation increased significantly after the intervention.",2020,"Gamification is an innovative pedagogical approach to addressing problems related to social behaviour, student motivation and academic performance at different educational stages.","['127 students participated in the study, divided into a gamified experimental group ( n = 62) and a control group ( n = 65', 'university students']",[],"['academic performance', 'Motivation and Academic Performance', 'external regulation']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041740', 'cui_str': 'University'}]",[],"[{'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",127.0,0.0193045,"Gamification is an innovative pedagogical approach to addressing problems related to social behaviour, student motivation and academic performance at different educational stages.","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ferriz-Valero', 'Affiliation': 'Department of General and Specifics Didactics, University of Alicante, 03690 San Vicente del Raspeig, Spain.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Østerlie', 'Affiliation': 'Research Group DiTePES: Digital Technology in Physical Education and Sports, NTNU-Norwegian University of Science and Technology, NO-7491 Trondheim, Norway.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'García Martínez', 'Affiliation': 'Department of General and Specifics Didactics, University of Alicante, 03690 San Vicente del Raspeig, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'García-Jaén', 'Affiliation': 'Department of General and Specifics Didactics, University of Alicante, 03690 San Vicente del Raspeig, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124465']
1043,32442384,Cycling reduces blood glucose excursions after an oral glucose tolerance test in pregnant women: a randomized crossover trial.,"The aim of this study was to evaluate the effect of an acute bout of cycling immediately after oral glucose intake on glucose metabolism in pregnant women at risk for gestational diabetes mellitus (GDM). Fifteen pregnant women with BMI ≥ 27 kg/m 2 were enrolled in a randomized crossover controlled study and underwent two oral glucose tolerance tests (OGTTs) ingesting 75 g of glucose followed by either 20 min of stationary cycling at moderate intensity (65%-75% maximal heart rate) or rest. Using continuous glucose monitors, glucose was measured up to 48 h after the OGTT. Glucose, insulin, and C-peptide were determined at baseline and after 1 and 2 h. One hour after glucose intake, mean blood glucose was significantly lower after cycling compared with rest ( p = 0.002). Similarly, mean glucose peak level was significantly lower after cycling compared with after rest ( p = 0.039). Lower levels of insulin and C-peptide were observed after 1 h ( p < 0.01). Differences in glucose measurements after 2 h and up to 48 h were not statistically different. We found that 20 min of cycling at moderate intensity after glucose intake reduced blood glucose excursions in pregnant women at risk for GDM. ClinicalTrials.gov Identifier: NCT03644238. Novelty Bullets In pregnant women, we found that cycling after glucose intake resulted in significantly lower glucose levels compared with rest. The exercise intervention studied is feasible for pregnant women and could be readily used to reduce glucose excursions.",2020,"One hour after glucose intake, mean blood glucose was significantly lower after cycling compared to rest (p=0.002).","['pregnant women at risk for GDM. Novelty Bullets: •', 'pregnant women at risk for gestational diabetes mellitus (GDM', 'Fifteen pregnant women with BMI ≥ 27kg/m2', 'pregnant women']","['oral glucose tolerance tests (OGTTs) ingesting 75-gram glucose followed by either 20 minutes of stationary cycling', 'exercise intervention', 'oral glucose intake']","['Glucose, insulin and C-peptide', 'blood glucose excursions', 'glucose measurements', 'glucose levels', 'mean blood glucose', 'glucose metabolism', 'mean glucose peak level', 'Lower levels of insulin and C-peptide']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0336699', 'cui_str': 'Bullet'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439835', 'cui_str': 'Stationary'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556133', 'cui_str': 'Glucose intake'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",15.0,0.0364558,"One hour after glucose intake, mean blood glucose was significantly lower after cycling compared to rest (p=0.002).","[{'ForeName': 'Mette Bisgaard', 'Initials': 'MB', 'LastName': 'Andersen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N., Denmark.'}, {'ForeName': 'Per Glud', 'Initials': 'PG', 'LastName': 'Ovesen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N., Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Daugaard', 'Affiliation': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N., Denmark.'}, {'ForeName': 'Eva Bjerre', 'Initials': 'EB', 'LastName': 'Ostenfeld', 'Affiliation': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N., Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Fuglsang', 'Affiliation': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N., Denmark.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0020']
1044,32442673,Salivary oxytocin after oxytocin administration: Examining the moderating role of childhood trauma.,"Although oxytocin administration influences behavior, its effects on peripheral oxytocin concentrations are mixed and derived from studies on healthy subjects. Additionally, trauma attenuates the behavioral effects of oxytocin, but it is unknown whether it also influences its effect on peripheral circulation. This study examined whether salivary oxytocin increased after oxytocin administration and whether trauma attenuated this effect. We conducted a randomized, double-blind, placebo-controlled, within-subjects study in 100 male adolescents living in residential youth care facilities. Participants self-administered intranasally 24 IU of oxytocin and placebo (one week later) and provided a saliva sample before and 15 min after administration. Salivary oxytocin increased significantly after oxytocin administration, but this effect might be inflated by exogenous oxytocin reaching the throat. Trauma did not moderate this effect. Our findings suggest that trauma did not attenuate the effect of oxytocin administration on salivary oxytocin, but more robust methodologies are recommended to draw more solid conclusions.",2020,Trauma did not moderate this effect.,"['100 male adolescents living in residential youth care facilities', 'healthy subjects']","['oxytocin', 'salivary oxytocin', 'Salivary oxytocin', 'oxytocin and placebo', 'placebo']","['Salivary oxytocin', 'peripheral oxytocin concentrations']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",100.0,0.442201,Trauma did not moderate this effect.,"[{'ForeName': 'Iro', 'Initials': 'I', 'LastName': 'Fragkaki', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR, Nijmegen, the Netherlands. Electronic address: i.fragkaki@pwo.ru.nl.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Glennon', 'Affiliation': 'Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Cima', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR, Nijmegen, the Netherlands.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107903']
1045,32445247,Benefits of extracorporeal shock waves for keloid treatment: A pilot study.,"Keloids are fibroproliferative skin disorders characterized by the progressive deposition of collagen. Recently, extracorporeal shock wave therapy (ESWT) has been used to treat pathologic scars. Herein, we conducted a study to compare the efficacy of intralesional injections (ILIs) of triamcinolone acetonide (TA) used alone, or in combination with ESWT for keloids. Forty patients were randomized equally into two groups in this 12-week comparative clinical trial. Group A was treated with TA ILIs and ESWT, and group B was treated with TA ILIs alone. At week 12, both groups showed acceptable improvements in nearly all dimensions evaluated, and these improvements were statistically more significant in group A. Group A showed a higher mean percentage reduction in lesion length, width, and height and in the Vancouver Scar Scale score than group B (all P < .05). More patients in group A than in group B had scores of ≥4, which indicated improvements that were good or excellent, on the patient global assessment and investigator global assessment. No serious adverse events occurred. This study suggests that ESWT could be a new, effective and acceptable adjuvant treatment option for keloids.",2020,"More patients in group A than in group B had scores of ≥4, which indicated improvements that were good or excellent, on the PGA and IGA.",['Forty patients'],"['TA ILIs and ESWT', 'extracorporeal shock wave therapy (ESWT', 'intralesional injections (ILIs) of triamcinolone acetonide (TA', 'ESWT', 'TA ILIs alone', 'extracorporeal shock waves for keloid treatment']","['lesion length, width, and height and in the VSS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0021490', 'cui_str': 'Intralesional injection'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0022548', 'cui_str': 'Keloid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0138915,"More patients in group A than in group B had scores of ≥4, which indicated improvements that were good or excellent, on the PGA and IGA.","[{'ForeName': 'Dong Hee', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Seok Hyun', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Dermatology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Ho Seok', 'Initials': 'HS', 'LastName': 'Suh', 'Affiliation': 'Department of Dermatology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Yu Sung', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': 'Department of Dermatology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}]",Dermatologic therapy,['10.1111/dth.13653']
1046,32447602,Reduction of fat free mass index and phase angle is a risk factor for development digital ulcers in systemic sclerosis patients.,"INTRODUCTION/OBJECTIVES
This study aims to evaluate the role of fat free mass index (FFMI) and phase angle (PhA) as markers to predict occurrence of new digital ulcers in systemic sclerosis (SSc) patients.
METHODS
Body composition evaluation from bioelectrical impedance and clinical assessment were performed in SSc patients at enrollment and after 12 months follow-up.
RESULTS
Seventy-nine SSc patients (67 female) with a mean age of 53 ± 13 years were enrolled. In SSc patients with a digital ulcers history, FFMI value is lower (p < 0.05) and phase angle (PhA) value is higher (p < 0.01) than SSc patients without a digital ulcers history. After 12 months of follow-up, 30 patients (38%) presented at least one new episode of digital ulcers. Patients with reduced FFMI had a relative risk of 6.7 for new digital ulcers (CI 2.1-21.8, p < 0.001). Patients with reduced PhA had a relative risk of 10.1 for new digital ulcers (CI 3.5-29.5, p < 0.0001). In multivariate analysis, FFMI and PhA were associated with major vascular complication (digital ulcers, pulmonary arterial hypertension, and scleroderma renal crisis). FFMI loss, assessed as delta between follow-up and baseline, is higher in SSc with short duration (≤ 3 years) than SSc patients with long duration [0.4 (0-0.50) vs - 0.10 (- 0.2-0)].
CONCLUSION
In SSc patients, reduction of the FFMI and PhA represents after 12 months a risk factor for development of new digital ulcers and major vascular complication. Key Points • Fat free mass index represents a risk factor for development of digital ulcers • Phase angle represents a risk factor for development of digital ulcers • Body compositions in systemic sclerosis are a marker of activity disease.",2020,"In SSc patients with a digital ulcers history, FFMI value is lower (p < 0.05) and phase angle (PhA) value is higher (p < 0.01) than SSc patients without a digital ulcers history.","['systemic sclerosis (SSc) patients', 'SSc patients at enrollment and after 12\xa0months follow-up', 'Seventy-nine SSc patients (67 female) with a mean age of 53\u2009±\u200913\xa0years were enrolled', 'systemic sclerosis patients']",[],"['FFMI value', 'new digital ulcers', 'major vascular complication (digital ulcers, pulmonary arterial hypertension, and scleroderma renal crisis', 'FFMI loss']","[{'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3267035', 'cui_str': 'Digital ulcer'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C1262147', 'cui_str': 'Scleroderma renal crisis'}]",79.0,0.0320459,"In SSc patients with a digital ulcers history, FFMI value is lower (p < 0.05) and phase angle (PhA) value is higher (p < 0.01) than SSc patients without a digital ulcers history.","[{'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Rosato', 'Affiliation': ""Department of Translational and Precision Medicine-Scleroderma Unit, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy. edoardo.rosato@uniroma1.it.""}, {'ForeName': 'Antonietta', 'Initials': 'A', 'LastName': 'Gigante', 'Affiliation': ""Department of Translational and Precision Medicine-Scleroderma Unit, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Iacolare', 'Affiliation': ""Department of Translational and Precision Medicine-Scleroderma Unit, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.""}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Villa', 'Affiliation': ""Department of Translational and Precision Medicine-Scleroderma Unit, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.""}, {'ForeName': 'Maria Ludovica', 'Initials': 'ML', 'LastName': 'Gasperini', 'Affiliation': ""Department of Translational and Precision Medicine-Scleroderma Unit, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.""}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Muscaritoli', 'Affiliation': ""Department of Translational and Precision Medicine-Scleroderma Unit, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.""}]",Clinical rheumatology,['10.1007/s10067-020-05141-0']
1047,32459643,Adherence to Blended or Face-to-Face Smoking Cessation Treatment and Predictors of Adherence: Randomized Controlled Trial.,"BACKGROUND
Blended face-to-face and web-based treatment is a promising way to deliver smoking cessation treatment. Since adherence has been shown to be an indicator of treatment acceptability and a determinant for effectiveness, we explored and compared adherence and predictors of adherence to blended and face-to-face alone smoking cessation treatments with similar content and intensity.
OBJECTIVE
The objectives of this study were (1) to compare adherence to a blended smoking cessation treatment with adherence to a face-to-face treatment; (2) to compare adherence within the blended treatment to its face-to-face mode and web mode; and (3) to determine baseline predictors of adherence to both treatments as well as (4) the predictors to both modes of the blended treatment.
METHODS
We calculated the total duration of treatment exposure for patients (N=292) of a Dutch outpatient smoking cessation clinic who were randomly assigned either to the blended smoking cessation treatment (n=130) or to a face-to-face treatment with identical components (n=162). For both treatments (blended and face-to-face) and for the two modes of delivery within the blended treatment (face-to-face vs web mode), adherence levels (ie, treatment time) were compared and the predictors of adherence were identified within 33 demographic, smoking-related, and health-related patient characteristics.
RESULTS
We found no significant difference in adherence between the blended and the face-to-face treatments. Participants in the blended treatment group spent an average of 246 minutes in treatment (median 106.7% of intended treatment time, IQR 150%-355%) and participants in the face-to-face group spent 238 minutes (median 103.3% of intended treatment time, IQR 150%-330%). Within the blended group, adherence to the face-to-face mode was twice as high as that to the web mode. Participants in the blended group spent an average of 198 minutes (SD 120) in face-to-face mode (152% of the intended treatment time) and 75 minutes (SD 53) in web mode (75% of the intended treatment time). Higher age was the only characteristic consistently found to uniquely predict higher adherence in both the blended and face-to-face groups. For the face-to-face group, more social support for smoking cessation was also predictive of higher adherence. The variability in adherence explained by these predictors was rather low (blended R 2 =0.049; face-to-face R 2 =0.076). Within the blended group, living without children predicted higher adherence to the face-to-face mode (R 2 =0.034), independent of age. Higher adherence to the web mode of the blended treatment was predicted by a combination of an extrinsic motivation to quit, a less negative attitude toward quitting, and less health complaints (R 2 =0.164).
CONCLUSIONS
This study represents one of the first attempts to thoroughly compare adherence and predictors of adherence of a blended smoking cessation treatment to an equivalent face-to-face treatment. Interestingly, although the overall adherence to both treatments appeared to be high, adherence within the blended treatment was much higher for the face-to-face mode than for the web mode. This supports the idea that in blended treatment, one mode of delivery can compensate for the weaknesses of the other. Higher age was found to be a common predictor of adherence to the treatments. The low variance in adherence predicted by the characteristics examined in this study suggests that other variables such as provider-related health system factors and time-varying patient characteristics should be explored in future research.
TRIAL REGISTRATION
Netherlands Trial Register NTR5113; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5113.",2020,"Within BSCT, adherence to the face-to-face mode was twice as high as to the web-mode.",['patients (N=292) of a Dutch outpatient smoking cessation clinic'],"['blended smoking cessation treatment (BSCT, N=162) or to a face-to-face treatment with identical ingredients', 'Blended Treatment with Face-To-Face Treatment', 'BSCT', 'blended smoking cessation treatment (BSCT) with adherence to a face-to-face treatment (F2F']","['adherence', 'adherence levels', 'negative attitude toward quitting and less health complaints']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1262620', 'cui_str': 'Negative attitude'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]",,0.0203694,"Within BSCT, adherence to the face-to-face mode was twice as high as to the web-mode.","[{'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Siemer', 'Affiliation': 'Technology, Health & Care Research Group, Saxion University of Applied Sciences, Enschede, Netherlands.'}, {'ForeName': 'Marjolein G J', 'Initials': 'MGJ', 'LastName': 'Brusse-Keizer', 'Affiliation': 'Medical School Twente, Medisch Spectrum Twente, Enschede, Netherlands.'}, {'ForeName': 'Marloes G', 'Initials': 'MG', 'LastName': 'Postel', 'Affiliation': 'Department of Psychology, Health & Technology, University of Twente, Enschede, Netherlands.'}, {'ForeName': 'Somaya', 'Initials': 'S', 'LastName': 'Ben Allouch', 'Affiliation': 'Digital Life Research Group, Amsterdam University of Applied Science, Amsterdam, Netherlands.'}, {'ForeName': 'Robbert', 'Initials': 'R', 'LastName': 'Sanderman', 'Affiliation': 'Department of Psychology, Health & Technology, University of Twente, Enschede, Netherlands.'}, {'ForeName': 'Marcel E', 'Initials': 'ME', 'LastName': 'Pieterse', 'Affiliation': 'Centre for eHealth and Well-being Research, University of Twente, Enschede, Netherlands.'}]",Journal of medical Internet research,['10.2196/17207']
1048,32459987,Client memory and learning of treatment contents: An experimental study of intervention strategies and relationship to outcome in a brief treatment for procrastination.,"BACKGROUND AND OBJECTIVES
Client memory and learning is limited for psychological treatment contents. This study investigated different approaches to support client memory and learning of treatment contents and the relationship between memory and learning of treatment contents and outcome.
METHODS
Adult participants (n = 428) were recruited through Amazon's Mechanical Turk and randomized to complete one of three versions of a one-session procrastination intervention. Two versions of the intervention included different amounts of memory support strategy types from the Memory Support Intervention. A control version did not include any types of memory support. Memory and learning of treatment contents were assessed immediately after the intervention and one week later. Procrastination and two mechanisms of procrastination (impulsiveness and self-efficacy) were assessed at baseline and one week after the intervention.
RESULTS
Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention. Greater memory and learning of treatment contents predicted improvement in mechanisms of procrastination, but not procrastination itself.
LIMITATIONS
The mean level of procrastination in this study was lower than in other treatment studies of procrastination.
CONCLUSIONS
Results partially support the rationale for the Memory Support Intervention that improving client memory and learning of treatment contents can improve outcome. Findings suggest that the Memory Support Intervention may be simplified to include fewer strategies without compromising efficacy.",2020,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.",['Adult participants (n\xa0=\xa0428'],"[""Amazon's Mechanical Turk""]","['Memory and learning of treatment contents', 'procrastination (impulsiveness and self-efficacy', 'mean level of procrastination', 'Client memory and learning of treatment contents']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517775', 'cui_str': '428'}]","[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0871142', 'cui_str': 'Procrastination'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]",428.0,0.032357,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.","[{'ForeName': 'Garret G', 'Initials': 'GG', 'LastName': 'Zieve', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Woodworth', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'University of California, Berkeley, United States. Electronic address: aharvey@berkeley.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101579']
1049,32460816,"Efficacy of neoadjuvant endocrine therapy compared with neoadjuvant chemotherapy in pre-menopausal patients with oestrogen receptor-positive and HER2-negative, lymph node-positive breast cancer.","INTRODUCTION
Neoadjuvant endocrine therapy (NET) has demonstrated efficacy in post-menopausal patients with hormone-responsive breast cancer. This trial was designed to compare the efficacy of neoadjuvant chemotherapy (NCT) with NET in pre-menopausal breast cancer.
PATIENTS AND METHODS
In this prospective, randomised, phase III study, oestrogen receptor (ER)-positive, HER2-negative, and lymph node-positive pre-menopausal breast cancer patients were recruited from 7 hospitals in South Korea. Enrolled patients were randomly assigned (1:1) to receive 24 weeks of either NCT or NET with goserelin and tamoxifen. The primary purpose was to evaluate the non-inferiority of NET compared to NCT using clinical response, assessed by MRI. Besides, pathological complete response rate (pCR), changes in Ki-67 expression, breast conservation surgery (BCS) rate, and quality of life were included as secondary endpoints.
RESULTS
A total of 187 patients were assigned to receive NCT (n = 95) or NET (n = 92), and 87 patients in each group completed treatments. More NCT patients had complete response or partial response than NET patients using MRI (NCT 83.7% vs. NET 52.9%, 95% CI 17.6-44.0, p < 0.001) and callipers (NCT 83.9% vs. NET 71.3%, 95% CI 0.4-24.9, p = 0.046). Three NCT patients (3.4%) and one NET patient (1.2%) showed pCR (p < 0.005). No difference existed in the conversion rate of BCS (13.8% for NCT vs. 11.5% for NET, p = 0.531) and Ki-67 change (p = 0.114) between the two groups. Nineteen NCT patients had treatment-related grade 3 or worse events compared with none in the NET group.
CONCLUSIONS
Better clinical responses were observed in pre-menopausal patients after 24 weeks of NCT compared to those observed after NET.
TRIAL REGISTRATION
Clinicaltrials.gov, NCT01622361. Registration June 19, 2012.",2020,"More NCT patients had complete response or partial response than NET patients using MRI (NCT 83.7% vs. NET 52.9%, 95% CI 17.6-44.0, p < 0.001) and callipers (NCT 83.9% vs. NET 71.3%, 95% CI 0.4-24.9, p = 0.046).","['pre-menopausal patients with oestrogen receptor-positive and HER2-negative, lymph node-positive breast cancer', 'post-menopausal patients with hormone-responsive breast cancer', 'lymph node-positive pre-menopausal breast cancer patients were recruited from 7 hospitals in South Korea', 'A total of 187 patients']","['NCT or NET with goserelin and tamoxifen', 'NCT', 'Neoadjuvant endocrine therapy (NET', 'NET', 'neoadjuvant endocrine therapy', 'neoadjuvant chemotherapy (NCT) with NET', 'neoadjuvant chemotherapy']","['Ki-67 change', 'pathological complete response rate (pCR), changes in Ki-67 expression, breast conservation surgery (BCS) rate, and quality of life', 'conversion rate of BCS', 'complete response or partial response']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517618', 'cui_str': '187'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}]",187.0,0.239105,"More NCT patients had complete response or partial response than NET patients using MRI (NCT 83.7% vs. NET 52.9%, 95% CI 17.6-44.0, p < 0.001) and callipers (NCT 83.9% vs. NET 71.3%, 95% CI 0.4-24.9, p = 0.046).","[{'ForeName': 'Hee Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, 88 Olympic ro 43 gil, song pa gu, Seoul, 138-736, South Korea.'}, {'ForeName': 'Woo Chul', 'Initials': 'WC', 'LastName': 'Noh', 'Affiliation': 'Department of Surgery, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, South Korea.'}, {'ForeName': 'Eun Sook', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Center for Breast Cancer, Research and Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Yong Sik', 'Initials': 'YS', 'LastName': 'Jung', 'Affiliation': 'Department of Surgery, School of Medicine, Ajou University, Suwon, South Korea.'}, {'ForeName': 'Lee Su', 'Initials': 'LS', 'LastName': 'Kim', 'Affiliation': 'Division of Breast and Endocrine Surgery, Hallym Sacred Heart Hospital, College of Medicine, Hallyum University, Anyang, South Korea.'}, {'ForeName': 'Wonshik', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Department of Surgery and Cancer Research Institute, College of Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Seok Jin', 'Initials': 'SJ', 'LastName': 'Nam', 'Affiliation': 'Department of Surgery, Samsung Medical Center, School of Medicine, Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Gyung -Yub', 'Initials': 'G-', 'LastName': 'Gong', 'Affiliation': 'Department of Pathology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hwa Jung', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Preventive Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Sei Hyun', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, 88 Olympic ro 43 gil, song pa gu, Seoul, 138-736, South Korea. ahnsh@amc.seoul.kr.'}]",Breast cancer research : BCR,['10.1186/s13058-020-01288-5']
1050,32482611,Aluminium salt-based antiperspirant coated prosthesis liners do not suppress local sweating during moderate intensity exercise in hot and temperate conditions.,"OBJECTIVE
To determine whether coating prosthesis liners with a 5% aluminium zirconium tetrachlorohydrate antiperspirant solution (AZCH) reduces local sweating on the thigh.
DESIGN
Double-blinded counter-balanced crossover design METHODS: Fourteen able-bodied participants (age: 28±5 y; body mass: 73.9±7.9kg, height: 1.73±0.09m; peak oxygen consumption [VO 2peak ]: 50.7±9.1 mlO 2 ⋅kg -1 ⋅min -1 ) simultaneously wore a prosthesis liner on each leg, one treated with AZCH and one untreated, for four days prior to running at 50% of VO 2peak for 60min in a temperate (23.7±0.7°C and 42.2±2.6% relative humidity) or hot (34.0±1.6°C and 40.8±6.1% relative humidity) environment. Rectal temperature (T re ) and whole-body sweat rates (WBSR) were measured to characterize thermal strain. Local sweat rate (LSR) was measured bilaterally underneath the liners, continuously, and heat-activated-sweat gland density (HASGD) was measured bilaterally every 15min.
RESULTS
In temperate condition, the mean change in T re was 1.2±0.4°C and WBSR was 723±129g⋅h -1 , whereas in the hot condition, change in T re was 1.2±0.5°C and WBSR was 911±231g⋅h -1 . In the temperate condition, AZCH treatment did not alter LSR (treated: 0.50±0.17 mg·cm -2 min -1 , untreated: 0.50±0.17 mg·cm -2 min -1 ; P=0.87) or HASGD (treated: 54±14 glands·cm -2 , untreated 55±14 glands·cm -2 ; P=0.38). In the hot condition, AZCH treatment paradoxically increased LSR (treated: 0.88±0.38 mg·cm -2 min -1 , untreated: 0.74±0.28 mg·cm -2 min -1 ; P=0.04) but not HASGD (treated: 52±17 glands·cm -2 , untreated: 48±19 glands·cm -2 ; P=0.77).
CONCLUSION
These results indicate coating prosthesis liners with 5% AZCH is ineffective at reducing local sweating.",2020,"untreated: 0.74±0.28 mg·cm -2 min -1 ; P=0.04) but not HASGD (treated: 52±17 glands·cm -2 , untreated: 48±19 glands·cm -2 ; P=0.77).
CONCLUSION
","['Fourteen able-bodied participants (age: 28±5 y; body mass: 73.9±7.9kg, height: 1.73±0.09m; peak oxygen consumption [VO 2peak ]: 50.7±9.1']","['HASGD', 'Aluminium salt-based antiperspirant coated prosthesis liners', 'coating prosthesis liners with a 5% aluminium zirconium tetrachlorohydrate antiperspirant solution (AZCH', 'AZCH']","['Local sweat rate (LSR', 'LSR', 'Rectal temperature (T re ) and whole-body sweat rates (WBSR', 'local sweating']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]","[{'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0701858', 'cui_str': 'Antiperspirants'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0181663', 'cui_str': 'Liner'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0043506', 'cui_str': 'Zirconium'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0257472', 'cui_str': '(5)AZCH'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]",,0.0908167,"untreated: 0.74±0.28 mg·cm -2 min -1 ; P=0.04) but not HASGD (treated: 52±17 glands·cm -2 , untreated: 48±19 glands·cm -2 ; P=0.77).
CONCLUSION
","[{'ForeName': 'Nathan B', 'Initials': 'NB', 'LastName': 'Morris', 'Affiliation': 'Thermal Ergonomics Laboratory, Faculty of Health Sciences, University of Sydney, Australia; Department of Nutrition, Exercise and Sports, Section for Integrative Physiology, University of Copenhagen, Denmark. Electronic address: nathan.morris@sydney.edu.au.'}, {'ForeName': 'Ollie', 'Initials': 'O', 'LastName': 'Jay', 'Affiliation': 'Thermal Ergonomics Laboratory, Faculty of Health Sciences, University of Sydney, Australia; Charles Perkins Centre, University of Sydney, Australia.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.05.012']
1051,32552691,Modified-ramped position: a new position for intubation of obese females: a randomized controlled pilot study.,"BACKGROUND
Endotracheal intubation requires optimum position of the head and neck. In obese females, the usual ramped position might not provide adequate intubating conditions. We hypothesized that a new position, termed modified-ramped position, during induction of anesthesia would facilitate endotracheal intubation through bringing the breasts away from the laryngoscope and would also improve the laryngeal visualization.
METHODS
Sixty obese female patients scheduled for general anesthesia were randomly assigned into either ramped or modified-ramped position during induction of anesthesia. In the ramped position (n = 30), the patient head and shoulders were elevated to achieve alignment of the sternal notch and the external auditory meatus; while in the modified-ramped position (n = 30), the patient shoulders were elevated using a special pillow, and the head was extended to the most possible range. Our primary outcome was the incidence of failed laryngoscopic insertion in the oral cavity (the need for patient repositioning). Other outcomes included time till vocal cord visualization, time till successful endotracheal intubation, difficulty of the mask ventilation, and Cormack-Lehane grade for laryngeal view.
RESULTS
Fourteen patients (47%) in ramped group required repositioning to facilitate introduction of the laryngoscope in the oral cavity in comparison to one patient (3%) in the modified-ramped position (p < 0.001). Modified-ramped position showed lower incidence of difficult mask ventilation, shorter time for glottic visualization, and shorter time for endotracheal tube insertion compared to the ramped position. The Cormack-Lehane grade was better in the modified-ramped position.
CONCLUSION
Modified-ramped position provided better intubating conditions, improved the laryngeal view, and eliminated the need for repositioning of obese female patients during insertion of the laryngoscope compared to ramped position.
CLINICAL TRIAL REGISTRATION
Identifier: NCT03640442. Date: August 2018.",2020,"RESULTS
Fourteen patients (47%) in ramped group required repositioning to facilitate introduction of the laryngoscope in the oral cavity in comparison to one patient (3%) in the modified-ramped position (p < 0.001).","['obese females', 'obese female patients', 'Sixty obese female patients scheduled for general anesthesia']","['ramped or modified-ramped position during induction of anesthesia', 'Modified-ramped position']","['time till vocal cord visualization, time till successful endotracheal intubation, difficulty of the mask ventilation, and Cormack-Lehane grade for laryngeal view', 'incidence of failed laryngoscopic insertion in the oral cavity (the need for patient repositioning', 'incidence of difficult mask ventilation, shorter time for glottic visualization, and shorter time for endotracheal tube insertion']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C2362912', 'cui_str': 'Patient Moving and Lifting'}, {'cui': 'C4706398', 'cui_str': 'Difficult mask ventilation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}]",60.0,0.0652977,"RESULTS
Fourteen patients (47%) in ramped group required repositioning to facilitate introduction of the laryngoscope in the oral cavity in comparison to one patient (3%) in the modified-ramped position (p < 0.001).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasanin', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt. ahmedmohamedhasanin@gmail.com.'}, {'ForeName': 'Hager', 'Initials': 'H', 'LastName': 'Tarek', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Maha M A', 'Initials': 'MMA', 'LastName': 'Mostafa', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Amany', 'Initials': 'A', 'LastName': 'Arafa', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Ahmed G', 'Initials': 'AG', 'LastName': 'Safina', 'Affiliation': 'Department of surgery, Cairo university, Giza, Egypt.'}, {'ForeName': 'Mona H', 'Initials': 'MH', 'LastName': 'Elsherbiny', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Hosny', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Gado', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Almenesey', 'Affiliation': 'Department of anesthesia and critical care medicine, Beni suef university, Beni suef, Egypt.'}, {'ForeName': 'Ghada Adel', 'Initials': 'GA', 'LastName': 'Hamden', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Mahmoud', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Amin', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Giza, Egypt.'}]",BMC anesthesiology,['10.1186/s12871-020-01070-2']
1052,32559759,Short-term nicotine deprivation alters dorsal anterior cingulate glutamate concentration and concomitant cingulate-cortical functional connectivity.,"Most cigarette smokers who wish to quit too often relapse within the first few days of abstinence, primarily due to the aversive aspects of the nicotine withdrawal syndrome (NWS), which remains poorly understood. Considerable research has suggested that the dorsal anterior cingulate cortex (dACC) plays a key role in nicotine dependence, with its functional connections between other brain regions altered as a function of trait addiction and state withdrawal. The flow of information between dACC and fronto-striatal regions is secured through different pathways, the vast majority of which are glutamatergic. As such, we investigated dACC activity using resting state functional connectivity (rsFC) with functional magnetic resonance imaging (fMRI) and glutamate (Glu) concentration with magnetic resonance spectroscopy (MRS). We also investigated the changes in adenosine levels in plasma during withdrawal as a surrogate for brain adenosine, which plays a role in fine-tuning synaptic glutamate transmission. Using a double-blind, placebo-controlled, randomized crossover design, nontreatment seeking smoking participants (N = 30) completed two imaging sessions, one while nicotine sated and another after 36 h nicotine abstinence. We observed reduced dACC Glu (P = 0.029) along with a significant reduction in plasma adenosine (P = 0.03) and adenosine monophosphate (AMP; P < 0.0001) concentrations during nicotine withdrawal in comparison with nicotine sated state. This withdrawal state manipulation also led to an increase in rsFC strength (P < 0.05) between dACC and several frontal cortical regions, including left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG). Moreover, the state-trait changes in dACC Glu and rsFC strength between the dACC and both SFG and MFG were positively correlated (P = 0.012, and P = 0.007, respectively). Finally, the change in circuit strength between dACC and LSFG was negatively correlated with the change in withdrawal symptom manifestations as measured by the Wisconsin Smoking Withdrawal Scale (P = 0.04) and Tobacco Craving Questionnaire (P = 0.014). These multimodal imaging-behavioral findings reveal the complex cascade of changes induced by acute nicotine deprivation and call for further investigation into the potential utility of adenosine- and glutamate-signaling as novel therapeutic targets to treat the NWS.",2020,"This withdrawal state manipulation also led to an increase in rsFC strength (P < 0.05) between dACC and several frontal cortical regions, including left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG).",['nontreatment seeking smoking participants (N\u2009=\u200930) completed two'],"['placebo', 'Short-term nicotine deprivation', 'imaging sessions, one while nicotine sated and another after 36\u2009h nicotine abstinence', 'functional magnetic resonance imaging (fMRI) and glutamate (Glu) concentration with magnetic resonance spectroscopy (MRS']","['plasma adenosine', 'left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG', 'Wisconsin Smoking Withdrawal Scale', 'dACC Glu', 'dACC Glu and rsFC strength', 'rsFC strength', 'withdrawal symptom manifestations', 'circuit strength', 'Tobacco Craving Questionnaire']","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0152296', 'cui_str': 'Structure of superior frontal gyrus'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152297', 'cui_str': 'Structure of middle frontal gyrus'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0275209,"This withdrawal state manipulation also led to an increase in rsFC strength (P < 0.05) between dACC and several frontal cortical regions, including left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG).","[{'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Abulseoud', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA. osama.abulseoud@nih.gov.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ross', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Hyung Wook', 'Initials': 'HW', 'LastName': 'Nam', 'Affiliation': 'Department of Pharmacology, Toxicology and Neuroscience, LSU Health Sciences Center, Shreveport, LA, USA.'}, {'ForeName': 'Elisabeth C', 'Initials': 'EC', 'LastName': 'Caparelli', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tennekoon', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Schleyer', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Castillo', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fedota', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Stein', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0741-9']
1053,32563858,Capitalizing on cross-language similarities in intervention with bilingual children.,"PURPOSE
This study examined the effects of a vocabulary intervention for bilingual children that was conducted in children's first language, Spanish, and included explicit instruction on cognates. We measured effects in terms of change from pre- to post-intervention in Spanish as well as associations with the non-target language, English.
METHOD
Participants were 12 Spanish-English bilingual children, aged 6-8 years, with and without Developmental Language Disorder. Children completed the intervention in pairs (one child with DLD and a typically developing peer) for 70-minute sessions, 3 days a week, for four weeks. Intervention targeted 32 words (16 cognates, 16 non-cognates) using four storybooks (8 words/book) and interactive activities that highlighted similarities across languages. Pre- and post-intervention measures in Spanish and English included tasks of word definition and cognate facilitation.
RESULTS
As a group, children showed improvement in definition quality and cognate naming in Spanish. There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD. All children showed positive cross-language correlations on post-intervention measures.
CONCLUSIONS
Bilingual children, with and without DLD, have the capacity to improve in their awareness and use of cognates. Explicit teaching of cognates can be an effective tool for building vocabulary skills. Children with DLD may need additional time and support to apply their knowledge of cognates to vocabulary learning.",2020,"There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD.","[""bilingual children that was conducted in children's first language, Spanish, and included explicit instruction on cognates"", 'Children with DLD', 'Participants were 12 Spanish-English bilingual children, aged 6-8 years, with and without Developmental Language Disorder', 'Spanish and English']",['vocabulary intervention'],"['included tasks of word definition and cognate facilitation', 'definition quality and cognate naming', 'positive cross-language correlations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0557073', 'cui_str': 'First language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023014', 'cui_str': 'Developmental language disorder'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",,0.0437372,"There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD.","[{'ForeName': 'Quynh', 'Initials': 'Q', 'LastName': 'Dam', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States; University of California San Diego, 9500 Gilman Dr, La Jolla, CA 92093, United States. Electronic address: qdam@sdsu.edu.'}, {'ForeName': 'Giang T', 'Initials': 'GT', 'LastName': 'Pham', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: gpham@sdsu.edu.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Pruitt-Lord', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: spruitt@sdsu.edu.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Limon-Hernandez', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: jlimon-hernandez@sdsu.edu.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Goodwiler', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: cgoodwiler@sdsu.edu.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106004']
1054,32572652,Ticagrelor Versus Clopidogrel in Patients with Late or Very Late Stent Thrombosis.,"PURPOSE
To compare the effect of ticagrelor with clopidogrel in reducing the risk of ischemic cardiovascular events in patients with late or very late stent thrombosis (LST/VLST) after primary percutaneous coronary intervention (PCI).
METHODS
A total of 4538 patients with acute coronary syndrome were screened for angiographically determined LST/VLST. Two hundred and forty-one patients were included in the analysis and grouped according to ticagrelor (n = 81) or clopidogrel (n = 160) at discharge. The clinical outcome was major adverse cardiovascular events (MACE) defined as death, myocardial infarction (MI), ischemic stroke, and revascularization during the 1-yr follow-up period.
RESULTS
After propensity score matching, 65 pairs were generated. The incidence of MACE was significantly lower in the ticagrelor group compared with the clopidogrel group (9.3% vs. 21.5%, log-rank p = 0.048). However, no difference was observed in event rates of death, MI, ischemic stroke, and revascularization between the ticagrelor group and the clopidogrel group.
CONCLUSION
Following successful primary PCI, patients with LST/VLST who received ticagrelor had fewer ischemic cardiovascular events at 1-yr follow-up, compared with those who received clopidogrel.",2020,"However, no difference was observed in event rates of death, MI, ischemic stroke, and revascularization between the ticagrelor group and the clopidogrel group.
","['patients with late or very late stent thrombosis (LST/VLST) after primary percutaneous coronary intervention (PCI', 'n\u2009=\u2009160) at discharge', 'Patients with Late or Very Late Stent Thrombosis', 'Two hundred and forty-one patients were included in the analysis and grouped according to ticagrelor (n\u2009=\u200981) or', '4538 patients with acute coronary syndrome']","['ticagrelor with clopidogrel', 'Ticagrelor Versus Clopidogrel', 'clopidogrel', 'ticagrelor']","['incidence of MACE', 'event rates of death, MI, ischemic stroke, and revascularization', 'ischemic cardiovascular events', 'major adverse cardiovascular events (MACE) defined as death, myocardial infarction (MI), ischemic stroke, and revascularization during the 1-yr follow-up period']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",4538.0,0.0802211,"However, no difference was observed in event rates of death, MI, ischemic stroke, and revascularization between the ticagrelor group and the clopidogrel group.
","[{'ForeName': 'Jinying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhaoxue', 'Initials': 'Z', 'LastName': 'Sheng', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiannan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Runzhen', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. hbyanfuwai2018@163.com.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-07021-w']
1055,32574801,Emotion generation and regulation following an intrusion induction: Implications for taboo or autogenous obsessions.,"BACKGROUND AND OBJECTIVES
Research demonstrates that autogenous (AO) and reactive obsessions (RO) differ in obsessional content; however, no experimental research has examined differences in emotion generation and regulation. Characterizing this taxonomy with respect to emotion generation and regulation could refine conceptualizations of obsessionality and optimize clinical interventions.
METHODS
Seventy undergraduates were randomly assigned to imagine a personally-relevant AO or RO. Subsequently, emotional reactivity was assessed. Participants then rated their emotion regulation efforts and the degree to which the intrusion violated their values.
RESULTS
Broadly aligning with expectations, bootstrapped linear regression models indicated that AOs led to a significant increase in self-conscious emotions (guilt, shame, and embarrassment), and these effects were stronger for those whose values were more severely threatened by the intrusion. A conditional process analysis revealed that the relationship between the AO condition and emotion regulation difficulties was explained by an increase in negative emotional reactivity, and the strength of this effect depended upon the degree of conflict with participants' values.
LIMITATIONS
The use of an analogue sample, and minimal emotional reactivity in the RO condition, threaten the ecological and external validity of the study.
CONCLUSIONS
The current study employed a novel experimental design demonstrating a meaningful relationship between AOs and both emotional activation and regulation. Results highlight the relevance of self-conscious emotions to the conceptualization of AOs and the utility of addressing them in the context of exposure therapy.",2020,"Broadly aligning with expectations, bootstrapped linear regression models indicated that AOs led to a significant increase in self-conscious emotions (guilt, shame, and embarrassment), and these effects were stronger for those whose values were more severely threatened by the intrusion.","['taboo or autogenous obsessions', 'Seventy undergraduates']",['imagine a personally-relevant AO or RO'],"['negative emotional reactivity', 'self-conscious emotions (guilt, shame, and embarrassment', 'AO condition and emotion regulation difficulties', 'emotional reactivity']","[{'cui': 'C0039227', 'cui_str': 'Taboo'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0679112', 'cui_str': 'Embarrassment'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",70.0,0.0314195,"Broadly aligning with expectations, bootstrapped linear regression models indicated that AOs led to a significant increase in self-conscious emotions (guilt, shame, and embarrassment), and these effects were stronger for those whose values were more severely threatened by the intrusion.","[{'ForeName': 'Noah Chase', 'Initials': 'NC', 'LastName': 'Berman', 'Affiliation': 'College of the Holy Cross, Department of Psychology, 1 College St, Worcester, MA, 01610, USA. Electronic address: nberman@holycross.edu.'}, {'ForeName': 'Jumi', 'Initials': 'J', 'LastName': 'Hayaki', 'Affiliation': 'College of the Holy Cross, Department of Psychology, 1 College St, Worcester, MA, 01610, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Szkutak', 'Affiliation': 'College of the Holy Cross, Department of Psychology, 1 College St, Worcester, MA, 01610, USA.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101593']
1056,32444994,"""BAX602"" in Preventing Surgical Adhesion after Extracorporeal Ventricular Assist Device Implantation for Refractory Congestive Heart Failure: Study Protocol for a Multicenter Randomized Clinical Trial.","BACKGROUND
The high surgical risk in redo cardiac surgery is largely attributed to adhesions around the epicardium and the great vessels. BAX602 is an adhesion prevention reagent composed of two synthetic polyethylene glycols. Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery. The present study aims to evaluate the safety and effectiveness of BAX602 spray in patients undergoing extracorporeal ventricular assist device implantation surgery to treat refractory congestive heart failure.
METHODS AND DESIGN
This investigator-initiated, multicenter, pivotal, two-arm, open-label, randomized trial will include a total of 30 patients. The primary outcome measure is the severity of adhesions, which will be evaluated during re-sternotomy surgery performed 2-12 weeks after the primary extracorporeal ventricular assist device implantation surgery. The adhesion severity will be evaluated at five predefined sites using a four-grade adhesion evaluation score (0 = no adhesion; 1 = filmy and avascular adhesion; 2 = dense/vascular adhesion; 3 = cohesive adhesion). This measure will be summarized in two ways to evaluate the effect of BAX602: (1) the total score of the severity of adhesions at all five sites (ranging from 0 to 15), and (2) the total number of sites with dense/vascular or cohesive adhesions (ranging from 0 to 5).
ETHICS AND DISSEMINATION
The study findings will be disseminated at regional, national, and international conferences and through peer-reviewed scientific journals.
TRIAL REGISTRATION
The trial was registered in the UMIN Clinical Trials Registry (UMIN-CTR: UMIN000038998) on 6 January 2020.",2020,Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery.,"['Refractory Congestive Heart Failure', '30 patients', 'patients undergoing']","['Extracorporeal Ventricular Assist Device Implantation', 'BAX602 spray', 'BAX602', 'extracorporeal ventricular assist device implantation surgery']","['safety and effectiveness', 'severity of adhesions, which will be evaluated during re-sternotomy surgery', 'adhesion severity']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0397128', 'cui_str': 'Implantation of ventricular assist device'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",30.0,0.202345,Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery.,"[{'ForeName': 'Satsuki', 'Initials': 'S', 'LastName': 'Fukushima', 'Affiliation': 'Department of Cardiac Surgery, National Cerebral and Cardiovascular Center, 6-1 Kishibeshimmachi, Suita, Osaka, 564-8565, Japan. s.fukushima@ncvc.go.jp.'}, {'ForeName': 'Koko', 'Initials': 'K', 'LastName': 'Asakura', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Hamasaki', 'Affiliation': 'The Biostatistics Center and Department of Biostatistics and Bioinformatics, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Onda', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of Transplant Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shiose', 'Affiliation': 'Department of Cardiovascular Surgery, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiac Surgery, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Norihide', 'Initials': 'N', 'LastName': 'Fukushima', 'Affiliation': 'Department of Transplant Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of Cardiac Surgery, National Cerebral and Cardiovascular Center, 6-1 Kishibeshimmachi, Suita, Osaka, 564-8565, Japan.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-06990-2']
1057,32446280,Does performance-based financing curb stock-outs of essential medicines? Results from a randomised controlled trial in Cameroon.,"OBJECTIVE
In 2011, the government of Cameroon launched its performance-based financing (PBF) scheme. Our study examined the effects of the PBF intervention on the availability of essential medicines (EM).
METHODS
Randomised control trial whereby PBF and three distinct comparison groups were randomised in a total of 205 health facilities across three regions. Baseline data were collected between March and May 2012 and endline data 36 months later. We defined availability of multiple EM groups by assessing stock-outs for at least one day over the 30 days prior to the survey date and estimated changes attributable to PBF using a series of difference-in-difference regression models, adjusted for relevant facility-level covariates. Data were analysed stratified by region and area to assess effect heterogeneity.
RESULTS
Our estimates suggest that PBF intervention had no effect on the stock-outs of antenatal care drugs (P = 0.160), vaccines (P = 0.396), integrated management of childhood illness drugs (P = 0.681) and labour and delivery drugs (P = 0.589). However, the intervention was associated with a significant reduction of 34% in stock-outs of family planning medicines (P = 0.028). We observed effect heterogeneity across regions and areas, with significant decreases in stock-outs of family planning products in North-West region (P = 0.065) and in rural areas (P = 0.043).
CONCLUSIONS
The PBF intervention in Cameroon had limited effects on the reduction of EMs stock-outs. These poor results were likely the consequence of partial implementation failure, ranging from disruption and discontinuation of services to limited facility autonomy in managing decision-making and considerable delay in performance payment.",2020,"We observed effect heterogeneity across regions and areas, with significant decreases in stock-outs of family planning products in North-West region (p = 0.065) and in rural areas (p = 0.043).
",['205 health facilities across three regions'],"['PBF intervention', 'PBF']","['stock-outs of antenatal care drugs', 'stock-outs of family planning products']","[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243097', 'cui_str': 'financing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0453908', 'cui_str': 'Stocking'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}]",,0.070051,"We observed effect heterogeneity across regions and areas, with significant decreases in stock-outs of family planning products in North-West region (p = 0.065) and in rural areas (p = 0.043).
","[{'ForeName': 'Isidore', 'Initials': 'I', 'LastName': 'Sieleunou', 'Affiliation': 'University of Montreal Public Health Research Institute, Montreal, QC, Canada.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'De Allegri', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Roland Enok Bonong', 'Affiliation': 'School of Public Health, University of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Samiratou', 'Initials': 'S', 'LastName': 'Ouédraogo', 'Affiliation': 'Institut National de Santé Publique du Québec, Montréal, QC, Canada.'}, {'ForeName': 'Valéry', 'Initials': 'V', 'LastName': 'Ridde', 'Affiliation': 'School of Public Health, University of Montreal, Montreal, QC, Canada.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13447']
1058,32449678,Arterial stiffness and kidney disease progression in the systolic blood pressure intervention trial
.,"AIMS
Arterial stiffness increases with both advancing age and chronic kidney disease (CKD) and may contribute to kidney function decline, but evidence is inconsistent. We hypothesized that greater baseline arterial stiffness (assessed as pulse pressure (PP) and carotid-femoral pulse-wave velocity CFPWV)) was independently associated with kidney disease progression over the follow-up period (3.8 years) in the Systolic Blood Pressure Intervention Trial (SPRINT).
MATERIALS AND METHODS
8,815 SPRINT participants were included in the analysis of PP. 592 adults who participated in a SPRINT ancillary study that measured CFPWV were included in subgroup analyses. Cox proportional hazards analysis was used to examine the association between PP and time to kidney disease progression endpoints: (A) incident estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m 2 in non-CKD participants at baseline; (B) 50% decline in eGFR, initiation of dialysis, or transplant in those with baseline CKD. Mixed model analyses examined the association of baseline PP/CFPWV with follow-up eGFR.
RESULTS AND CONCLUSION
Mean ± SD age was 68 ± 10 years, baseline PP was 62 ± 14 mmHg, and CFPWV was 10.8 ± 2.7 m/s. In the fully adjusted model, PP ≥ median was associated with an increased hazard of kidney disease progression endpoints (HR: 1.93 (1.43 - 2.61)). The association remained significant in individuals without (2.05 (1.47 - 2.87)) but not with baseline CKD (1.28 (0.55 - 2.65)). In fully adjusted models, higher baseline PP associated with eGFR decline (p < 0.0001 (all, CKD, non-CKD)), but baseline CFPWV did not. Among older adults at high risk for cardiovascular events, baseline PP was associated with kidney disease progression.",2020,The association remained significant in individuals without (2.05 (1.47 - 2.87)) but not with baseline CKD (1.28 (0.55 - 2.65)).,"['8,815 SPRINT participants were included in the analysis of PP', 'SD age was 68\xa0±\xa010 years, baseline PP was 62\xa0±', '592 adults who participated in a SPRINT ancillary study that measured CFPWV were included in subgroup analyses', 'older adults']",[],"['Mean\xa0±', 'Arterial stiffness and kidney disease progression', 'baseline arterial stiffness', 'glomerular filtration rate (eGFR', 'pulse pressure (PP) and carotid-femoral pulse-wave velocity CFPWV', 'hazard of kidney disease progression endpoints', 'eGFR decline', 'kidney disease progression']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",8815.0,0.068225,The association remained significant in individuals without (2.05 (1.47 - 2.87)) but not with baseline CKD (1.28 (0.55 - 2.65)).,"[{'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Nowak', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jovanovich', 'Affiliation': ''}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'You', 'Affiliation': ''}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': ''}, {'ForeName': 'Monique E', 'Initials': 'ME', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Glasser', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lash', 'Affiliation': ''}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Simmons', 'Affiliation': ''}, {'ForeName': 'Addison', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weiner', 'Affiliation': ''}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': ''}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': ''}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Supiano', 'Affiliation': ''}]",Clinical nephrology,['10.5414/CN109982']
1059,32448788,Effects of a multifactorial ecosustainable isocaloric diet on liver fat in patients with type 2 diabetes: randomized clinical trial.,"INTRODUCTION
Treatment options for non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes (T2D) are still a matter of debate. We compared the effects of a diet including different components versus a proven beneficial diet rich in monounsaturated fatty acids (MUFAs) on liver fat in T2D.
RESEARCH DESIGN AND METHODS
According to a parallel design, 49 individuals with T2D, overweight/obese, with high waist circumference, 35-75 years-old, in satisfactory blood glucose control with diet or drugs not affecting liver fat content, were randomly assigned to an 8-week isocaloric intervention with a MUFA diet (n=26) or a multifactorial diet rich in fiber, MUFA, n-6 and n-3 polyunsaturated fatty acids, polyphenols, and vitamins D, E, and C (n=23). Before and after the intervention, liver fat content was evaluated by proton magnetic resonance spectroscopy ( 1 H-MRS). 1 H-MRS complete data were available for n=21 (MUFA diet) and n=18 (multifactorial diet) participants.
RESULTS
Adherence to dietary interventions was optimal. No significant differences between groups in body weight reduction, plasma glycated hemoglobin, insulin, glucose, lipids and liver enzymes were observed. Liver fat significantly decreased after both the multifactorial diet (9.18%±7.78% vs 5.22%±4.80%, p = 0.003) and the MUFA diet (9.47%±8.89% vs 8.07%±8.52%, p = 0.027) with a statistically significant difference between changes either in absolute terms (-4.0%±4.5% vs -1.4%±2.7%, p=0.035) or percent (-40%±33% vs -19%±25%, p=0.030).
CONCLUSIONS
An isocaloric multifactorial diet including several beneficial dietary components induced a clinically relevant reduction of liver fat in patients with T2D, more pronounced than that induced by simply replacing saturated fat with MUFA. This suggests that the 'optimal diet' for NAFLD treatment in T2D should be based on synergic actions of different dietary components on multiple pathophysiological pathways.
TRIAL REGISTRATION NUMBER
NCT03380416.",2020,"No significant differences between groups in body weight reduction, plasma glycated hemoglobin, insulin, glucose, lipids and liver enzymes were observed.","['49 individuals with T2D, overweight/obese, with high waist circumference, 35-75\u2009years-old, in satisfactory blood glucose control with diet or drugs not affecting liver fat content', 'patients with T2D', 'patients with type 2 diabetes', 'patients with type 2 diabetes (T2D']","['isocaloric intervention with a MUFA diet (n=26) or a multifactorial diet rich in fiber, MUFA, n-6 and n-3 polyunsaturated fatty acids, polyphenols, and vitamins D, E, and C', 'multifactorial ecosustainable isocaloric diet', 'diet including different components versus a proven beneficial diet rich in monounsaturated fatty acids (MUFAs']","['liver fat', 'MUFA diet', 'Liver fat', 'body weight reduction, plasma glycated hemoglobin, insulin, glucose, lipids and liver enzymes', 'liver fat content']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0456369', 'cui_str': 'Proven'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",49.0,0.0243611,"No significant differences between groups in body weight reduction, plasma glycated hemoglobin, insulin, glucose, lipids and liver enzymes were observed.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Della Pepa', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Vetrani', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Brancato', 'Affiliation': 'IRCCS SDN, Napoli, Campania, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Monti', 'Affiliation': 'Institute of Biostructure and Bioimaging, National Research Council, Napoli, Campania, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Annuzzi', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Lombardi', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Izzo', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Tommasone', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cipriano', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Clemente', 'Affiliation': 'Institute for Research on Population and Social Policies, National Research Council, Fisciano, Italy.'}, {'ForeName': 'Peppino', 'Initials': 'P', 'LastName': 'Mirabelli', 'Affiliation': 'IRCCS SDN, Napoli, Campania, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Mancini', 'Affiliation': 'Institute of Biostructure and Bioimaging, National Research Council, Napoli, Campania, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Salvatore', 'Affiliation': 'IRCCS SDN, Napoli, Campania, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Riccardi', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}, {'ForeName': 'Angela Albarosa', 'Initials': 'AA', 'LastName': 'Rivellese', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy rivelles@unina.it.'}, {'ForeName': 'Lutgarda', 'Initials': 'L', 'LastName': 'Bozzetto', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II School of Medicine and Surgery, Napoli, Campania, Italy.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001342']
1060,32451660,Ovarian stimulation after dehydroepiandrosterone supplementation in poor ovarian reserve: a randomized clinical trial.,"OBJECTIVE
This study aimed at improving fertility rates among infertile women with poor ovarian reserve.
METHODS
This was a randomized clinical trial conducted in the outpatient clinic of a tertiary hospital. We recruited infertile women with poor ovarian reserve. The study population was divided into 2 groups, each of 25 participants. Both had induction of ovulation for three consecutive cycles. Study group took DHEA supplementation 25 mg/8 h for two consecutive cycles before induction of ovulation. Both groups were compared for outcomes of induction. Baseline ovarian reserve tests and antral follicle count (AFC) were done for both groups before induction of ovulation. The study group repeated these baseline tests after DHEA treatment to compare ovarian reserve before and after DHEA supplementation. Outcome measures were the number of mature follicles at the time of ovulation, the number of gonadotrophin ampoules needed for induction of ovulation, the duration of ovarian stimulation, E2 level at the day of HCG injection.
RESULTS
The study group baseline investigations after DHEA treatment showed a statistically significant improvement compared to the control group. The outcomes of induction of ovulation in the study group showed a statistically better response than the control group.
CONCLUSION
DHEA may help many poor responders so better considered for poor responder patients.
TRIAL REGISTRATION NUMBER
PACTR201911829230395.",2020,"The outcomes of induction of ovulation in the study group showed a statistically better response than the control group.
","['poor ovarian reserve', 'outpatient clinic of a tertiary hospital', 'infertile women with poor ovarian reserve']","['DHEA supplementation', 'dehydroepiandrosterone supplementation']","['Ovarian stimulation', 'Baseline ovarian reserve tests and antral follicle count (AFC', 'induction of ovulation', 'fertility rates', 'number of mature follicles at the time of ovulation, the number of gonadotrophin ampoules needed for induction of ovulation, the duration of ovarian stimulation, E2 level at the day of HCG injection']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0029967', 'cui_str': 'Ovulation induction'}, {'cui': 'C0015912', 'cui_str': 'Fertility Rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600225', 'cui_str': 'Vesicular ovarian follicle structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0179031', 'cui_str': 'Ampule'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",,0.167646,"The outcomes of induction of ovulation in the study group showed a statistically better response than the control group.
","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elprince', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, 41111, Egypt. prince.ma939@yahoo.com.'}, {'ForeName': 'Eman A', 'Initials': 'EA', 'LastName': 'Kishk', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, 41111, Egypt.'}, {'ForeName': 'Ola M', 'Initials': 'OM', 'LastName': 'Metawie', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, 41111, Egypt.'}, {'ForeName': 'Magda M', 'Initials': 'MM', 'LastName': 'Albiely', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, 41111, Egypt.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05603-5']
1061,32452549,Lanadelumab demonstrates rapid and sustained prevention of hereditary angioedema attacks.,"BACKGROUND
Lanadelumab demonstrated efficacy in preventing hereditary angioedema (HAE) attacks in the phase 3 HELP Study.
OBJECTIVE
To assess time to onset of effect and long-term efficacy of lanadelumab, based on exploratory findings from the HELP Study.
METHODS
Eligible patients with HAE type I/II received lanadelumab 150 mg every 4 weeks (q4wks), 300 mg q4wks, 300 mg q2wks, or placebo. Ad hoc analyses evaluated day 0-69 findings using a Poisson regression model accounting for overdispersion. Least-squares mean monthly HAE attack rate for lanadelumab was compared with placebo. Intrapatient comparisons for days 0-69 versus steady state (days 70-182) used a paired t test for continuous endpoints or Kappa statistics for categorical endpoints.
RESULTS
One hundred twenty-five patients were randomized and treated. During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) vs placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs 1.66) and moderate/severe attacks (0.31-0.48 vs 1.33, all P ≤ .001). More patients receiving lanadelumab vs placebo were attack free (37.9%-48.1% vs 7.3%) and responders (85.7%-100% vs 26.8%). During steady state, the efficacy of lanadelumab vs placebo was similar or improved vs days 0-69. Intrapatient differences were significant with lanadelumab 300 mg q4wks for select outcomes. Lanadelumab efficacy was durable-HAE attack rate was consistently lower vs placebo, from the first 2 weeks of treatment through study end. Treatment emergent adverse events were comparable during days 0-69 and 70-182.
CONCLUSION
Protection with lanadelumab started from the first dose and continued throughout the entire study period.",2020,"During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) versus placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs. 1.66) and moderate/severe attacks (0.31-0.48 vs. 1.33, all P ≤ 0.001).","['125 patients', 'Eligible patients with HAE type I/II received']","['placebo', 'Lanadelumab', 'lanadelumab', 'lanadelumab 150 mg every 4 weeks (q4wks), 300 mg q4wks, 300 mg q2wks, or placebo', 'lanadelumab versus placebo']","['durable-HAE attack rate', 'mean monthly attack rate', 'attacks requiring acute treatment', 'HAE attack rate', 'moderate/severe attacks', 'attack free']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4505508', 'cui_str': 'lanadelumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",125.0,0.120587,"During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) versus placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs. 1.66) and moderate/severe attacks (0.31-0.48 vs. 1.33, all P ≤ 0.001).","[{'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Riedl', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Maurer', 'Affiliation': 'Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Division of Immunology/Allergy Section, Department of Internal Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Aleena', 'Initials': 'A', 'LastName': 'Banerji', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hilary J', 'Initials': 'HJ', 'LastName': 'Longhurst', 'Affiliation': ""Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge and University College London Hospitals, London, UK.""}, {'ForeName': 'H Henry', 'Initials': 'HH', 'LastName': 'Li', 'Affiliation': 'Institute for Asthma and Allergy, P.C., Chevy Chase, MD, USA.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': 'Shire, a Takeda company, Lexington, MA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hao', 'Affiliation': 'Shire, a Takeda company, Lexington, MA, USA.'}, {'ForeName': 'Salomé', 'Initials': 'S', 'LastName': 'Juethner', 'Affiliation': 'Shire, a Takeda company, Lexington, MA, USA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Lumry', 'Affiliation': 'Allergy and Asthma Research Associates, Dallas, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Allergy,['10.1111/all.14416']
1062,32454417,Induction chemotherapy followed by cisplatin or cetuximab concomitant to radiotherapy for laryngeal/hypopharyngeal cancer: Long-term results of the TREMPLIN randomised GORTEC trial.,"BACKGROUND
In Europe, induction chemotherapy (ICT) followed by radiotherapy is preferred to conventional chemoradiotherapy to avoid total laryngectomy in patients with laryngeal/hypopharyngeal cancer. In comparison with conventional radiotherapy, bioradiotherapy with cetuximab significantly improves locoregional control rates (LCRs) and overall survival (OS) without any increase in unmanageable toxicity.
METHODS
Patients included had untreated non-metastatic stage III-IV laryngeal/hypopharyngeal invasive squamous cell carcinoma. Good responders after three cycles of docetaxel-cisplatin-5-fluorouracil (TPF)-ICT (docetaxel and cisplatin, 75 mg/m 2 each on day 1, and 5-fluorouracil, 750 mg/m 2 /day on days 1-5) every 3 weeks were randomised to receive radiotherapy (70 Gy) with concurrent cisplatin (100 mg/m 2 /day on days 1, 22 and 43 of radiotherapy) or cetuximab (400 mg/m 2 of loading dose, 250 mg/m 2 /week during radiotherapy). The primary end-point was larynx preservation. The secondary end-points were laryngo-oesophageal dysfunction-free survival (LEDFS), LCR and OS.
RESULTS
A total of 153 patients were enrolled. Among 126 TPF-ICT responders, 116 were randomised to receive either cisplatin (n = 60) or cetuximab (n = 56). The median follow-up was 77.5 months. Five-year OS rates were 66.6% (95% confidence interval [CI]: 0.54-0.79) versus 66.9% (95% CI: 0.54-0.79) (p = 0.9), respectively. Five-year LCRs were 79.8% (95% CI: 69.5-90.0) versus 67.8% (95% CI: 55.1-80.5%) (p = 0.18). Five-year LEDFS was 62.2% (95% CI: 49.7-74.8%) versus 56.2% (95% CI: 43.0-69.4) (p = 0.38). Late grade III/IV salivary gland and laryngeal toxicity occurred in 10.3% versus 9.8% and 6.8% versus 11.8% of patients receiving cisplatin-radiotherapy versus cetuximab, respectively.
CONCLUSIONS
No significant difference in LEDFS was observed between the two arms. TPF-ICT followed by conventional chemoradiotherapy or cetuximab was feasible, and long-term toxicity was not statistically different between the two arms. LEDFS appears as a relevant end-point.",2020,"In comparison with conventional radiotherapy, bioradiotherapy with cetuximab significantly improves locoregional control rates (LCRs) and overall survival (OS) without any increase in unmanageable toxicity.
","['Patients included had untreated non-metastatic stage III-IV laryngeal/hypopharyngeal invasive squamous cell carcinoma', '126 TPF-ICT responders', 'laryngeal/hypopharyngeal cancer', '153 patients were enrolled', 'patients with laryngeal/hypopharyngeal cancer']","['radiotherapy (70\xa0Gy) with concurrent cisplatin', 'cisplatin-radiotherapy', 'radiotherapy', 'LEDFS', 'cetuximab', 'conventional chemoradiotherapy', 'induction chemotherapy (ICT', 'Induction chemotherapy followed by cisplatin or cetuximab concomitant to radiotherapy', 'cisplatin', 'conventional radiotherapy, bioradiotherapy with cetuximab', 'TPF)-ICT (docetaxel and cisplatin', '5-fluorouracil, 750\xa0mg/m 2', 'docetaxel-cisplatin-5-fluorouracil', 'TPF-ICT followed by conventional chemoradiotherapy or cetuximab']","['laryngo-oesophageal dysfunction-free survival (LEDFS), LCR\xa0and OS', 'LEDFS', 'locoregional control rates (LCRs) and overall survival (OS', 'larynx preservation', 'unmanageable toxicity', 'Late grade III/IV salivary gland and laryngeal toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0153398', 'cui_str': 'Malignant tumor of hypopharynx'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4517868', 'cui_str': '750'}]","[{'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0036098', 'cui_str': 'Salivary gland structure'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}]",153.0,0.178683,"In comparison with conventional radiotherapy, bioradiotherapy with cetuximab significantly improves locoregional control rates (LCRs) and overall survival (OS) without any increase in unmanageable toxicity.
","[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Janoray', 'Affiliation': 'Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D\'Oncologie et de Radiothérapie, Tours, France; Université François Rabelais de Tours, France; EA 7505, ""Education Ethique Santé"", EES, Tours, France. Electronic address: guillaume.janoray@yahoo.fr.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Clinique Sainte Catherine, Avignon, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sire', 'Affiliation': 'Centre Hospitalier de Lorient, Lorient, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Geoffrois', 'Affiliation': 'Institut de Cancérologie de Lorraine, Vandoeuvre Lès Nancy, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'de Raucourt', 'Affiliation': 'Centre François Baclesse, Caen, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Bardet', 'Affiliation': 'Centre René Gauducheau, Nantes, France.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Calais', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Garaud', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France.""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Calais', 'Affiliation': ""Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique D'Oncologie et de Radiothérapie, Tours, France; Université François Rabelais de Tours, France.""}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.009']
1063,32456979,A 4-week endurance training program improves tolerance to mental exertion in untrained individuals.,"OBJECTIVES
The aim of this study was to investigate whether 4 weeks of endurance training could improve tolerance to mental exertion in untrained participants.
DESIGN
Longitudinal training study.
METHODS
Twenty untrained young adults (14 F, 6 M; 27.6±6.2 years) completed a 4-week training protocol in a randomised and counterbalanced order. Baseline and follow-up assessment were conducted over three sessions in the week preceding and following the training period. During session 1, participants completed an incremental maximal ramp test. During sessions 2 and 3 participants completed a 15min cycling time trial preceded by either a mental exertion or control conditions. Following baseline assessments, participants were randomised into a physical training or placebo group that completed the training intervention thrice weekly over four weeks.
RESULTS
The physical training resulted in increase in VO 2 peak relative to the placebo group (p=0.003). Linear Mixed Models utilising the control condition time trial performance as a covariate found the physical training group increased their time trial distance following the mental exertion condition to a greater extent than the placebo group (p=0.03). RPE during the time trial and perceptual measures of mental exertion did not significantly change between groups (all p>0.10) although interaction effects were observed when considering the RPE-power output relationship during the time trial.
CONCLUSIONS
Four weeks of endurance training increased tolerance to mental exertion in untrained participants during a subsequent physical performance, but not during prolonged cognitive performance. This finding suggests that the ability to tolerate mental exertion is trainable in at least some contexts and highlights the far-reaching benefits of endurance training.",2020,The physical training resulted in increase in VO 2 peak relative to the placebo group (p=0.003).,"['Twenty untrained young adults (14 F, 6 M; 27.6±6.2 years) completed a', 'untrained individuals', 'untrained participants']","['4-week training protocol', 'endurance training program', 'physical training or placebo', 'mental exertion or control conditions', 'physical training', 'endurance training', 'placebo']","['VO 2 peak relative', 'mental exertion', 'time trial distance', 'tolerance to mental exertion']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",20.0,0.233526,The physical training resulted in increase in VO 2 peak relative to the placebo group (p=0.003).,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Filipas', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy. Electronic address: luca.filipas@unimi.it.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, ACT 2617, Australia; Discipline of Sport and Exercise Science, Faculty of Health, University of Canberra, ACT 2617, Australia.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Northey', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, ACT 2617, Australia; Discipline of Sport and Exercise Science, Faculty of Health, University of Canberra, ACT 2617, Australia.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'La Torre', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy; IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Keegan', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, ACT 2617, Australia; Discipline of Sport and Exercise Science, Faculty of Health, University of Canberra, ACT 2617, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Rattray', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, ACT 2617, Australia; Discipline of Sport and Exercise Science, Faculty of Health, University of Canberra, ACT 2617, Australia.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.04.020']
1064,32559656,Can theory of mind be improved? Positive expectations cause better theory of mind performance in a community sample.,"BACKGROUND AND OBJECTIVES
Theory of Mind (ToM) deficits are present in several mental disorders and closely related to problems in social functioning and lower quality of life. While several trainings are aimed at improving ToM performance, it is unknown whether positive expectations on a persons' ToM performance might cause better ToM achievement.
METHODS
Participants (n = 131) first completed a mock ToM test and were then randomly assigned to either receive standardized positive, negative or no feedback on their ToM performance. Secondly, their expectations on their own ToM performance were assessed. Thirdly, ToM was assessed using the Movie Task for the Assessment of Social Cognition (MASC).
RESULTS
Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance.
LIMITATIONS
In the present exploratory study, the effect of positive expectations on ToM performance was assessed in a community sample. Thus, the study should be replicated in a clinical sample for more in-depth results.
CONCLUSIONS
ToM performance could be enhanced by inducing positive expectations on one's ToM performance, whereas negative feedback had no effect. The present study suggest that interventions that focus on strengthening positive expectations on one's ToM performance could enhance the efficacy of present ToM training methods.",2020,"RESULTS
Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance.
",['Participants (n\xa0'],"['standardized positive, negative or no feedback on their ToM performance']","['Movie Task for the Assessment of Social Cognition (MASC', 'enhanced ToM performance', 'ToM performance']",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}]","[{'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}]",131.0,0.0319971,"RESULTS
Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance.
","[{'ForeName': 'Laura M-L', 'Initials': 'LM', 'LastName': 'Dorn', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University, Marburg, Germany. Electronic address: laura.dorn@staff.uni-marburg.de.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University, Marburg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mehl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Philipps-University, Marburg, Germany; Department of Social Work and Health, Frankfurt University of Applied Sciences, Germany.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101577']
1065,32567339,The Effects of Lipid-Lowering Therapy on Serum Eicosapentaenoic Acid to Arachidonic Acid Ratio: An HIJ-PROPER Sub-Analysis.,"BACKGROUND
Controversy remains regarding the influence of lipid-lowering therapy on the eicosapentaenoic acid/arachidonic acid ratio.
OBJECTIVE
This study aimed to clarify the effects of lipid-lowering therapy on the eicosapentaenoic acid/arachidonic acid ratio in patients with acute coronary syndrome (ACS).
METHODS
This was a post hoc sub-analysis of the Heart Institute of Japan-PRoper level of lipid-lowering with pitavastatin and ezetimibe in ACS study. We compared the eicosapentaenoic acid/arachidonic acid ratio changes from baseline to the 3-month follow-up after contemporary lipid-lowering therapy with pitavastatin + ezetimibe therapy and pitavastatin mono-therapy.
RESULTS
Among patients with ACS and dyslipidemia, the eicosapentaenoic acid/arachidonic acid increased significantly in the pitavastatin mono-therapy group (0.40 ± 0.26 to 0.46 ± 0.34, P < .0001) but did not increase in the pitavastatin + ezetimibe group (0.37 ± 0.22 to 0.38 ± 0.27, P = .18). When the analysis was limited to patients who received 2 mg/day of pitavastatin during the follow-up period, these trends in changes of the eicosapentaenoic acid/arachidonic acid ratio remained unchanged. Multivariate analysis showed that ezetimibe use ( P = .005; β = 0.09), ST-elevation myocardial infarction ( P = .04; β = -0.01), and baseline low-density lipoprotein cholesterol (LDL-C) level ( P = .0003; β = 0.12) were independent predictors of the percentage change in the eicosapentaenoic acid/arachidonic acid ratio. These trends were similar even when the analysis was limited to patients who did not take statins at enrollment.
CONCLUSION
Standard lipid-lowering therapy with pitavastatin mono-therapy improved the eicosapentaenoic acid/arachidonic acid ratio for patients with ACS. Intensive lipid-lowering therapy with pitavastatin + ezetimibe did not improve the eicosapentaenoic acid/arachidonic acid ratio, although LDL-C decreased significantly. Inhibition of the improvement in the eicosapentaenoic acid/arachidonic acid ratio by adding ezetimibe may affect cardiovascular disease prognosis.",2020,"Among patients with ACS and dyslipidemia, the eicosapentaenoic acid/arachidonic acid increased significantly in the pitavastatin mono-therapy group (0.40 ± 0.26 to 0.46 ± 0.34, P < .0001) but did not increase in the pitavastatin + ezetimibe group (0.37 ± 0.22 to 0.38 ± 0.27, P = .18).","['patients with ACS', 'patients with acute coronary syndrome (ACS']","['pitavastatin', 'eicosapentaenoic acid/arachidonic acid', 'pitavastatin mono-therapy', 'ezetimibe', 'eicosapentaenoic acid/arachidonic acid ratio', 'Lipid-Lowering Therapy', 'lipid-lowering therapy', 'pitavastatin and ezetimibe', 'pitavastatin + ezetimibe therapy and pitavastatin mono-therapy', 'pitavastatin + ezetimibe']","['eicosapentaenoic acid/arachidonic acid', 'baseline low-density lipoprotein cholesterol (LDL-C) level', 'eicosapentaenoic acid/arachidonic acid ratio, although LDL-C', 'eicosapentaenoic acid/arachidonic acid ratio', 'Serum Eicosapentaenoic Acid to Arachidonic Acid Ratio', 'ST-elevation myocardial infarction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}]",,0.0782305,"Among patients with ACS and dyslipidemia, the eicosapentaenoic acid/arachidonic acid increased significantly in the pitavastatin mono-therapy group (0.40 ± 0.26 to 0.46 ± 0.34, P < .0001) but did not increase in the pitavastatin + ezetimibe group (0.37 ± 0.22 to 0.38 ± 0.27, P = .18).","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, 13131Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, 13131Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Erisa', 'Initials': 'E', 'LastName': 'Kawada-Watanabe', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, 13131Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Otsuki', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, 13131Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Sekiguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, 13131Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, 13131Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, 13131Tokyo Women's Medical University, Tokyo, Japan.""}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420931621']
1066,32576090,Telemedicine Cognitive Behavioral Therapy for Anxiety After Stroke: Proof-of-Concept Randomized Controlled Trial.,"BACKGROUND AND PURPOSE
Disabling anxiety affects a quarter of stroke survivors but access to treatment is poor. We developed a telemedicine model for delivering guided self-help cognitive behavioral therapy (CBT) for anxiety after stroke (TASK-CBT). We aimed to evaluate the feasibility of TASK-CBT in a randomized controlled trial workflow that enabled all trial procedures to be carried out remotely. In addition, we explored the feasibility of wrist-worn actigraphy sensor as a way of measuring objective outcomes in this clinical trial.
METHODS
We recruited adult community-based stroke patients (n=27) and randomly allocated them to TASK-CBT (n=14) or relaxation therapy (TASK-Relax), an active comparator (n=13).
RESULTS
In our sample (mean age 65 [±10]; 56% men; 63% stroke, 37% transient ischemic attacks), remote self-enrolment, electronic signature, intervention delivery, and automated follow-up were feasible. All participants completed all TASK-CBT sessions (14/14). Lower levels of anxiety were observed in TASK-CBT when compared with TASK-Relax at both weeks 6 and 20. Mean actigraphy sensor wearing-time was 33 days (±15).
CONCLUSIONS
Our preliminary feasibility data from the current study support a larger definitive clinical trial and the use of wrist-worn actigraphy sensor in anxious stroke survivors. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03439813.",2020,Lower levels of anxiety were observed in TASK-CBT when compared with TASK-Relax at both weeks 6 and 20.,"['anxious stroke survivors', 'In our sample (mean age 65 [±10]; 56% men; 63% stroke, 37% transient ischemic attacks), remote self-enrolment, electronic signature, intervention delivery, and automated follow-up were feasible', 'adult community-based stroke patients (n=27']","['telemedicine model for delivering guided self-help cognitive behavioral therapy (CBT', 'Telemedicine Cognitive Behavioral Therapy', 'TASK-CBT', 'relaxation therapy (TASK-Relax), an active comparator (n=13', 'wrist-worn actigraphy sensor']","['Mean actigraphy sensor wearing-time', 'Lower levels of anxiety', 'Anxiety']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C2733435', 'cui_str': 'Guided self-help cognitive behavioral therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.157782,Lower levels of anxiety were observed in TASK-CBT when compared with TASK-Relax at both weeks 6 and 20.,"[{'ForeName': 'Ho-Yan Yvonne', 'Initials': 'HY', 'LastName': 'Chun', 'Affiliation': 'Centre for Clinical Brain Sciences (H.Y.Y.C., A.J.C., M.S.D., G.E.M., W.N.W.), University of Edinburgh, UK.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Carson', 'Affiliation': 'Centre for Clinical Brain Sciences (H.Y.Y.C., A.J.C., M.S.D., G.E.M., W.N.W.), University of Edinburgh, UK.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Tsanas', 'Affiliation': 'Centre for Medical Informatics, Usher Institute (A.T.), University of Edinburgh, UK.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Dennis', 'Affiliation': 'Centre for Clinical Brain Sciences (H.Y.Y.C., A.J.C., M.S.D., G.E.M., W.N.W.), University of Edinburgh, UK.'}, {'ForeName': 'Gillian E', 'Initials': 'GE', 'LastName': 'Mead', 'Affiliation': 'Centre for Clinical Brain Sciences (H.Y.Y.C., A.J.C., M.S.D., G.E.M., W.N.W.), University of Edinburgh, UK.'}, {'ForeName': 'Clementina', 'Initials': 'C', 'LastName': 'Calabria', 'Affiliation': 'Royal Infirmary of Edinburgh (C.C.), National Health Service Lothian, Edinburgh, UK.'}, {'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'Whiteley', 'Affiliation': 'Centre for Clinical Brain Sciences (H.Y.Y.C., A.J.C., M.S.D., G.E.M., W.N.W.), University of Edinburgh, UK.'}]",Stroke,['10.1161/STROKEAHA.120.029042']
1067,32576151,Intravenous lidocaine to prevent endothelial dysfunction after major abdominal surgery: a randomized controlled pilot trial.,"BACKGROUND
Major abdominal surgery is associated with endothelial glycocalyx disruption. The anti-inflammatory effects of lidocaine were recently associated with endothelial barrier protection.
METHODS
This was a single-centre, parallel group, randomized, controlled, double blind, pilot trial. Forty adult patients scheduled for major abdominal surgery were included between December 2016 and March 2017 in the setting of a University Hospital in Brussels (Belgium); reasons for non-inclusion were planned liver resection and conditions associated to increased risk of local anesthetics systemic toxicity. Patients were randomized to receive either lidocaine by continuous intravenous administration or an equivalent volume of 0.9% saline. The primary endpoint was the postoperative syndecan-1 concentration (difference between groups). Near-infrared spectroscopy of the thenar eminence in association with the vascular occlusion test, and contemporary analysis of flow-mediated dilation of the brachial artery were the secondary outcomes, along with haemodynamic data. Blood samples and data were collected before surgery (T0), and at 1-3 h (T1) and 24 h (T2) post-surgery.
RESULTS
Syndecan-1 concentration increased significantly post-surgery (P < 0.001), but without any difference between groups. The near-infrared spectroscopy-derived and flow-mediated dilation-derived variables showed minor changes unrelated to group assignment. Compared with the placebo group, the intervention group had a significantly lower peri-operative mean arterial pressure and cardiac index, despite equally conducted goal-directed haemodynamic management. Postoperative lactate concentrations were similar between groups.
CONCLUSIONS
Lidocaine failed to have any effect on endothelial function. Since in comparisons to other types of clinical situations, syndecan-1 was only slightly upregulated, endothelial dysfunction after major abdominal surgery might be overestimated.
TRIAL REGISTRATION
« ISRCTN Registry » identifier: ISRCTN63417725. Date: 15/06/2020. Retrospectively registered.",2020,"Compared with the placebo group, the intervention group had a significantly lower peri-operative mean arterial pressure and cardiac index, despite equally conducted goal-directed haemodynamic management.","['after major abdominal surgery', 'Forty adult patients scheduled for major abdominal surgery were included between December 2016 and March 2017 in the setting of a University Hospital in Brussels (Belgium); reasons for non-inclusion were planned liver resection and conditions associated to increased']","['Intravenous lidocaine', 'Lidocaine', 'lidocaine by continuous intravenous administration or an equivalent volume of 0.9% saline', 'lidocaine', 'placebo']","['endothelial function', 'peri-operative mean arterial pressure and cardiac index', 'Postoperative lactate concentrations', 'Syndecan-1 concentration', 'postoperative syndecan-1 concentration', 'risk of local anesthetics systemic toxicity', 'endothelial dysfunction']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4761262', 'cui_str': 'Local anaesthetic systemic toxicity'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}]",40.0,0.615618,"Compared with the placebo group, the intervention group had a significantly lower peri-operative mean arterial pressure and cardiac index, despite equally conducted goal-directed haemodynamic management.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pustetto', 'Affiliation': 'Department of Anesthesiology, Centre Hospitalier Universitaire Grenoble-Alpes, Boulevard de la Chantourne, 38700, Grenoble, France. marco.pustetto@gmail.com.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Goldsztejn', 'Affiliation': 'Department of Anesthesiology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Touihri', 'Affiliation': 'Department of Anesthesiology, CHIREC Hospital group, Brussels, Belgium.'}, {'ForeName': 'Edgard', 'Initials': 'E', 'LastName': 'Engelman', 'Affiliation': 'Department of Anesthesiology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Ickx', 'Affiliation': 'Department of Anesthesiology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Van Obbergh', 'Affiliation': 'Department of Anesthesiology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}]",BMC anesthesiology,['10.1186/s12871-020-01075-x']
1068,32445952,"Low-Fat, High-Fiber Diet Reduces Markers of Inflammation and Dysbiosis and Improves Quality of Life in Patients With Ulcerative Colitis.","BACKGROUND & AIMS
A high-fat diet has been associated with an increased risk of ulcerative colitis (UC). We studied the effects of a low-fat, high-fiber diet (LFD) vs an improved standard American diet (iSAD, included higher quantities of fruits, vegetables, and fiber than a typical SAD). We collected data on quality of life, markers of inflammation, and fecal markers of intestinal dysbiosis in patients with UC.
METHODS
We analyzed data from a parallel-group, cross-over study of 17 patients with UC in remission or with mild disease (with a flare within the past 18 mo), from February 25, 2015, through September 11, 2018. Participants were assigned randomly to 2 groups and received a LFD (10% of calories from fat) or an iSAD (35%-40% of calories from fat) for the first 4-week period, followed by a 2-week washout period, and then switched to the other diet for 4 weeks. All diets were catered and delivered to patients' homes, and each participant served as her or his own control. Serum and stool samples were collected at baseline and week 4 of each diet and analyzed for markers of inflammation. We performed 16s ribosomal RNA sequencing and untargeted and targeted metabolomic analyses on stool samples. The primary outcome was quality of life, which was measured by the short inflammatory bowel disease (IBD) questionnaire at baseline and week 4 of the diets. Secondary outcomes included changes in the Short-Form 36 health survey, partial Mayo score, markers of inflammation, microbiome and metabolome analysis, and adherence to the diet.
RESULTS
Participants' baseline diets were unhealthier than either study diet. All patients remained in remission throughout the study period. Compared with baseline, the iSAD and LFD each increased quality of life, based on the short IBD questionnaire and Short-Form 36 health survey scores (baseline short IBD questionnaire score, 4.98; iSAD, 5.55; LFD, 5.77; baseline vs iSAD, P = .02; baseline vs LFD, P = .001). Serum amyloid A decreased significantly from 7.99 mg/L at baseline to 4.50 mg/L after LFD (P = .02), but did not decrease significantly compared with iSAD (7.20 mg/L; iSAD vs LFD, P = .07). The serum level of C-reactive protein decreased numerically from 3.23 mg/L at baseline to 2.51 mg/L after LFD (P = .07). The relative abundance of Actinobacteria in fecal samples decreased from 13.69% at baseline to 7.82% after LFD (P = .017), whereas the relative abundance of Bacteroidetes increased from 14.6% at baseline to 24.02% on LFD (P = .015). The relative abundance of Faecalibacterium prausnitzii was higher after 4 weeks on the LFD (7.20%) compared with iSAD (5.37%; P = .04). Fecal levels of acetate (an anti-inflammatory metabolite) increased from a relative abundance of 40.37 at baseline to 42.52 on the iSAD and 53.98 on the LFD (baseline vs LFD, P = .05; iSAD vs LFD, P = .09). The fecal level of tryptophan decreased from a relative abundance of 1.33 at baseline to 1.08 on the iSAD (P = .43), but increased to a relative abundance of 2.27 on the LFD (baseline vs LFD, P = .04; iSAD vs LFD, P = .08); fecal levels of lauric acid decreased after LFD (baseline, 203.4; iSAD, 381.4; LFD, 29.91; baseline vs LFD, P = .04; iSAD vs LFD, P = .02).
CONCLUSIONS
In a cross-over study of patients with UC in remission, we found that a catered LFD or iSAD were each well tolerated and increased quality of life. However, the LFD decreased markers of inflammation and reduced intestinal dysbiosis in fecal samples. Dietary interventions therefore might benefit patients with UC in remission. ClinicalTrials.gov no: NCT04147598.",2020,"Compared to baseline, the iSAD and LFD each increased quality of life, based on the short IBD questionnaire and short-form 36 health survey scores (baseline short IBD questionnaire score, 4.98; iSAD, 5.55; LFD, 5.77; baseline vs iSAD P=.02; baseline vs LFD P=.001).","['patients with UC in remission', '17 patients with UC in remission or mild disease (with a flare within the last 18 months), from February 25, 2015 through September 11, 2018', 'Patients', 'patients with UC']","['Low-fat, High-fiber Diet', 'low-fat, high-fiber diet (LFD) vs an improved standard American diet (iSAD', 'LFD (10% of calories from fat) or an iSAD']","['relative abundance of Bacteroidetes', 'quality of life, based on the short IBD questionnaire and short-form 36 health survey scores (baseline short IBD questionnaire score', 'Serum amyloid', 'LFD decreased markers of inflammation and reduced intestinal dysbiosis', 'quality of life, markers of inflammation, and fecal markers of intestinal dysbiosis', 'Serum and stool samples', 'risk of ulcerative colitis (UC', 'Inflammation and Dysbiosis and Improves Quality of Life', 'changes in short-form 36 health survey, partial Mayo score, markers of inflammation, microbiome and metabolome analysis, and adherence to the diet', 'Serum level of C-reactive protein', 'Relative abundance of Actinobacteria in fecal samples', 'Relative abundance of Faecalibacterium prausnitzii', 'quality of life, which was measured by the short inflammatory bowel disease (IBD) questionnaire', 'Fecal levels of acetate (an anti-inflammatory metabolite', 'Fecal level of tryptophan', 'fecal levels of lauric acid', 'tolerated and increased quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3697010', 'cui_str': 'Ulcerative colitis in remission'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0301568', 'cui_str': 'High residue diet'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0301568', 'cui_str': 'High residue diet'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C4287543', 'cui_str': 'Intestinal dysbiosis'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1550661', 'cui_str': 'Stool specimen'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C3658208', 'cui_str': 'Dysbiosis'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0600148', 'cui_str': 'Class Actinobacteria'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0317558', 'cui_str': 'Faecalibacterium prausnitzii'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0023139', 'cui_str': 'Lauric acid'}]",17.0,0.0684843,"Compared to baseline, the iSAD and LFD each increased quality of life, based on the short IBD questionnaire and short-form 36 health survey scores (baseline short IBD questionnaire score, 4.98; iSAD, 5.55; LFD, 5.77; baseline vs iSAD P=.02; baseline vs LFD P=.001).","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fritsch', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida; Department of Microbiology and Immunology, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garces', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Quintero', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Pignac-Kobinger', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Santander', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Fernández', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Yuguang J', 'Initials': 'YJ', 'LastName': 'Ban', 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Deukwoo', 'Initials': 'D', 'LastName': 'Kwon', 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami-Leonard Miller School of Medicine, Miami, Florida; Division of Biostatistics, Department of Public Health Sciences, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Phillips', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Knight', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Mao', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St Paul, Minnesota.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Santaolalla', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Xi S', 'Initials': 'XS', 'LastName': 'Chen', 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami-Leonard Miller School of Medicine, Miami, Florida; Division of Biostatistics, Department of Public Health Sciences, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Mukil', 'Initials': 'M', 'LastName': 'Maruthamuthu', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Solis', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Oriana M', 'Initials': 'OM', 'LastName': 'Damas', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Kerman', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Amar R', 'Initials': 'AR', 'LastName': 'Deshpande', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St Paul, Minnesota.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Abreu', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida; Department of Microbiology and Immunology, University of Miami-Leonard Miller School of Medicine, Miami, Florida. Electronic address: Mabreu1@med.miami.edu.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.05.026']
1069,32458080,"Effectiveness of a combined 308-nm excimer lamp and topical mid-potent steroid treatment for facial vitiligo: a preliminary, randomized double-blinded controlled study.","Facial vitiligo has considerable psychological and emotional impacts. Though topical corticosteroids are the mainstay treatment, adverse reactions are a concern for prolonged use. Additionally, 308-nm excimer lamps have been widely used in vitiligo. This study aimed to assess the effectiveness of a combined 308-nm excimer lamp and topical steroid therapy compared with the lamp alone for treating facial vitiligo. Symmetrical, nonsegmental facial vitiligo subjects were recruited. All facial lesions were irradiated with a 308-nm excimer lamp twice weekly for a total of 24 sessions. The lesions on each side of the face were randomly allocated to have topical mometasone furoate cream or the cream base alone applied once daily for 12 weeks. Clinical improvement was evaluated by a blinded dermatologist and the participants. A total of sixteen sides of the face were assessed in the study. By the 12th week, 87.5% of the lesions treated with the combination regimen and 50% of the lesions treated with monotherapy showed good to excellent repigmentation. From the subjects' perspectives, there were significant differences between both treatments at week 4 and week 8 (p = 0.05) but not at week 12. No serious adverse effects were reported. A combination of excimer lamp therapy and once-daily application of topical mometasone cream was effective and could accelerate the treatment outcomes without serious adverse reactions. This may be an alternative regimen for treating facial vitiligo.",2020,No serious adverse effects were reported.,"['treating facial vitiligo', 'facial vitiligo', 'Symmetrical, nonsegmental facial vitiligo subjects']","['excimer lamp therapy', 'monotherapy', 'topical mometasone furoate cream', 'lamp alone', 'combined 308-nm excimer lamp and topical steroid therapy', '308-nm excimer lamp', 'combined 308-nm excimer lamp and topical mid-potent steroid treatment', 'topical mometasone cream']",['serious adverse effects'],"[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}]","[{'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0667581,No serious adverse effects were reported.,"[{'ForeName': 'Premjit', 'Initials': 'P', 'LastName': 'Juntongjin', 'Affiliation': 'Division of Dermatology, Chulabhorn International College of Medicine, Thammasat University, 10th Floor, Cooperative Learning Center, Piyachart2 Building, 99 Moo 18, Phaholyothin Road, Klong Luang, Pathum Thani, 12120, Thailand. premjitvp@yahoo.com.'}, {'ForeName': 'Nuttanit', 'Initials': 'N', 'LastName': 'Toncharoenphong', 'Affiliation': 'Division of Dermatology, Chulabhorn International College of Medicine, Thammasat University, 10th Floor, Cooperative Learning Center, Piyachart2 Building, 99 Moo 18, Phaholyothin Road, Klong Luang, Pathum Thani, 12120, Thailand.'}]",Lasers in medical science,['10.1007/s10103-020-03048-5']
1070,32461038,The Negative Impact of Psychotropic Drug Use on Quality of Life in Nursing Home Patients at Different Stages of Dementia: Cross-Sectional Analyses from the COSMOS Trial.,"OBJECTIVES
The quality of life (QoL) in nursing home (NH) patients with dementia is threatened by neuropsychiatric symptoms. This may trigger the use of psychotropic drugs, yet it is unknown if this practice improves the QoL. We investigated the association between the number of psychotropic drugs and QoL at different stages of dementia, adjusted for neuropsychiatric symptoms.
DESIGN
Cross-sectional analysis of baseline data from the COSMOS study, a multicenter, cluster-randomized, single-blinded, controlled trial.
SETTING AND PARTICIPATION
Four hundred thirty-one patients (aged ≥65 years) with and without dementia from 33 Norwegian NHs comprising 67 wards.
MEASURES
QoL assessed by Quality of Life in Late Stage Dementia (QUALID) and Quality of Life in Dementia (QUALIDEM), neuropsychiatric symptoms by Neuropsychiatric Inventory-Nursing Home version, and cognition by Mini-Mental State Examination.
RESULTS
At least 1 psychotropic drug was prescribed to 71% of the 431 participants included in the final sample. We estimated the trend in mean QoL scores over the number of psychotropic drugs in patients with clinical significant neuropsychiatric symptom load. QoL assessed by QUALID and QUALIDEM decreased by increasing number of psychotropic drugs (P < .001). No psychotropic drugs (mean QUALID score 20 ± 0.5, mean QUALIDEM score 40 ± 8.1) compared to ≥3 psychotropic drug (mean QUALID score 25 ± 7.8, mean QUALIDEM score 33 ± 8.0). This association was evident in mild, moderate, and severe dementia but absent in people without dementia. Use of antidepressant agents in mild and moderate dementia was associated with increased QoL compared with no use of antidepressant agents.
CONCLUSIONS AND IMPLICATIONS
Overall, our findings suggest that psychotropic drugs might pose a threat to QoL in NH patients at all stages of dementia, possibly with the exception of use of antidepressant agents in mild to moderate dementia. This underlines the need for updated knowledge on psychopharmacologic treatment and implementation of procedures for maintaining QoL in dementia care facilities.",2020,QoL assessed by QUALID and QUALIDEM decreased by increasing number of psychotropic drugs (P < .001).,"['nursing home (NH) patients with dementia is threatened by neuropsychiatric symptoms', 'Nursing Home Patients at Different Stages of Dementia', 'patients with clinical significant neuropsychiatric symptom load', 'Four hundred thirty-one patients (aged ≥65\xa0years) with and without dementia from 33 Norwegian NHs comprising 67 wards', '431 participants included in the final sample']",[],"['number of psychotropic drugs', 'quality of life (QoL', 'Quality of Life', 'Quality of Life in Late Stage Dementia (QUALID) and Quality of Life in Dementia (QUALIDEM), neuropsychiatric symptoms by Neuropsychiatric Inventory-Nursing Home version, and cognition by Mini-Mental State Examination', 'mean QoL scores']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",431.0,0.1136,QoL assessed by QUALID and QUALIDEM decreased by increasing number of psychotropic drugs (P < .001).,"[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Ito', 'Affiliation': 'School of Medicine, Tohoku University, Sendai, Japan.'}, {'ForeName': 'Line Iden', 'Initials': 'LI', 'LastName': 'Berge', 'Affiliation': 'Department of Global Public Health and Primary Care, Center for Elderly and Nursing Home Medicine, University of Bergen, Bergen, Norway; NKS Olaviken Gerontopsychiatric Hospital, Bergen, Norway.'}, {'ForeName': 'Bettina S', 'Initials': 'BS', 'LastName': 'Husebo', 'Affiliation': 'Department of Global Public Health and Primary Care, Center for Elderly and Nursing Home Medicine, University of Bergen, Bergen, Norway; Neuro-SysMed, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Nouchi', 'Affiliation': 'Department of Cognitive Health Science, Institute of Development, Aging and Cancer, Tohoku University, Sendai, Japan.'}, {'ForeName': 'Reidun K N M', 'Initials': 'RKNM', 'LastName': 'Sandvik', 'Affiliation': 'Department of Global Public Health and Primary Care, Center for Elderly and Nursing Home Medicine, University of Bergen, Bergen, Norway; Faculty of Health and Social Sciences, Department of Nursing, Western Norway University of Applied Sciences, Bergen, Norway. Electronic address: rks@hvl.no.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.03.028']
1071,32464527,Community-level interventions for pre-eclampsia (CLIP) in Mozambique: A cluster randomised controlled trial.,"OBJECTIVES
Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.
STUDY DESIGN
The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of CLIP contacts.
MAIN OUTCOME MEASURES
20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.
RESULTS
15,013 women (15,123 pregnancies) were recruited in intervention (N = 7930; 2·0% loss to follow-up (LTFU)) and control (N = 7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40). Compared with intervention arm women without CLIP contacts, those with ≥8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p = 0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p = 0·033).
INTERPRETATION
As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial.
FUNDING
The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","['pre-eclampsia (CLIP) in Mozambique', 'pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces', '15,013 women (15,123 pregnancies']","['CLIP intervention', 'task-sharing care', 'CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently', 'Community-level interventions', 'Mozambique Community-Level Interventions']","['maternal outcomes', 'composite of maternal, fetal, and newborn mortality and major morbidity', 'safety and evaluation of the intensity of CLIP contacts']","[{'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",15013.0,0.295538,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","[{'ForeName': 'Esperança', 'Initials': 'E', 'LastName': 'Sevene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique. Electronic address: esperanca.sevene@manhica.net.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Khátia', 'Initials': 'K', 'LastName': 'Munguambe', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Charfudin', 'Initials': 'C', 'LastName': 'Sacoor', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Anifa', 'Initials': 'A', 'LastName': 'Vala', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Salésio', 'Initials': 'S', 'LastName': 'Macuacua', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Direcção Provincial de Saúde, Ministério da Saúde, Av. Eduardo Mondlane n(o) 1008, CP 264 Maputo, Mozambique.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Boene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Orvalho', 'Initials': 'O', 'LastName': 'Augusto', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Cassimo', 'Initials': 'C', 'LastName': 'Bique', 'Affiliation': 'Departamento de Ginecologia e Obstetrícia, Hospital Central de Maputo, Av. Agostinho Neto n(o) 167, CP 1164 Maputo, Mozambique.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Eusébio', 'Initials': 'E', 'LastName': 'Macete', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Instituto Nacional de Saúde, Ministério da Saúde, Distrito de Marracuene, Estrada Nacional N(o) 1, Maputo, Mozambique.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Sidat', 'Affiliation': 'Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Corssino', 'Initials': 'C', 'LastName': 'Tchavana', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.006']
1072,32470312,Neuromuscular electrical stimulation and protein during bed rest increases CD11b + skeletal muscle macrophages but does not correspond to muscle size or insulin sensitivity.,"With this cohort, we previously demonstrated preservation of thigh lean tissue with neuromuscular electrical stimulation combined with protein supplementation (NMES+PRO) treatment during bed rest in healthy older adults. Because macrophage polarization plays a significant role in the repair and maintenance of muscle size and insulin sensitivity, we hypothesized that muscle macrophages would be induced by NMES+PRO and would correspond to an increase in lean mass and an attenuated insulin resistance response altered by bed rest. Older adults (60-80 years old; body mass index < 30 kg/m 2 ) underwent 5 days of bed rest and were randomized to either thrice daily treatment of NMES+PRO ( n = 8) or CON ( n = 8). Lean mass, insulin sensitivity, and markers of muscle macrophages, inflammation, and connective tissue were determined before and after bed rest. Glucose intolerance and insulin resistance occurred after bed rest but there was not a treatment effect ( p > 0.10). Proinflammatory-like macrophages (CD11b + , CD206 - ) increased ( p < 0.05) with NMES+PRO treatment and was different than CON. Minor changes in noncontractile tissue were observed. However, changes in muscle macrophages or extracellular matrix were not related to the preservation of thigh lean mass or insulin resistance. Daily NMES+PRO treatment during bed rest induced a muscle proinflammatory-like macrophage response and was unrelated to muscle size or metabolic function. This study is listed as clinical trial NCT02566590. Novelty Neuromuscular electrical stimulation combined with protein supplementation (NMES+PRO) increased proinflammatory-like macrophages and extracellular matrix content in older adults after bed rest. NMES+PRO changes in macrophages and noncontractile tissue macrophages were not related to muscle size preservation or insulin sensitivity.",2020,"Pro-inflammatory-like macrophages (CD11b+,CD206-) increased (p<0.05) with NMES+PRO treatment and was different than CON.","['Older adults (60-80y; BMI <30 kg/m2) underwent 5-days of bed rest', 'healthy older adults', 'older adults after bed rest']","['NMES+PRO', 'NMES+PRO(n=8) or CON', 'Daily NMES+PRO', 'neuromuscular electrical stimulation combined with protein supplementation (NMES+PRO', 'Neuromuscular electrical stimulation combined with protein supplementation (NMES+PRO']","['insulin resistance response', 'Lean mass, insulin sensitivity, and markers of muscle macrophages, inflammation and connective tissue', 'Glucose intolerance and insulin resistance', 'Pro-inflammatory-like macrophages (CD11b+,CD206', 'Novelty Bullets •']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0336699', 'cui_str': 'Bullet'}]",,0.065583,"Pro-inflammatory-like macrophages (CD11b+,CD206-) increased (p<0.05) with NMES+PRO treatment and was different than CON.","[{'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Reidy', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT 84018, USA.'}, {'ForeName': 'Logan T', 'Initials': 'LT', 'LastName': 'Edvalson', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT 84018, USA.'}, {'ForeName': 'Alec I', 'Initials': 'AI', 'LastName': 'McKenzie', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT 84018, USA.'}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Petrocelli', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT 84018, USA.'}, {'ForeName': 'Ziad S', 'Initials': 'ZS', 'LastName': 'Mahmassani', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT 84018, USA.'}, {'ForeName': 'Micah J', 'Initials': 'MJ', 'LastName': 'Drummond', 'Affiliation': 'Department of Physical Therapy and Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT 84018, USA.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0064']
1073,32484441,Facebook as a Novel Tool for Continuous Professional Education on Dementia: Pilot Randomized Controlled Trial.,"BACKGROUND
Social network sites (SNSs) are widely exploited in health education and communication by the general public, including patients with various conditions. Nevertheless, there is an absence of evidence evaluating SNSs in connecting health professionals for professional purposes.
OBJECTIVE
This pilot randomized controlled trial was designed to evaluate the feasibility of an intervention aiming to investigate the effects of a continuous professional education program utilizing Facebook to obtain knowledge on dementia and care for patients with dementia.
METHODS
Eighty health professionals from Hong Kong were recruited for participation in the study and randomized at a 1:1 ratio by a block randomization method to the intervention group (n=40) and control group (n=40). The intervention was an 8-week educational program developed to deliver updated knowledge on dementia care from a multidisciplinary perspective, either by Facebook (intervention group) or by email (control group) from October 2018 to January 2019. The primary outcomes were the effects of the intervention, measured by differences in the means of changes in pre- and postintervention scores of knowledge assessments from the 25-item Dementia Knowledge Assessment Scale (DKAS) and formative evaluation of 20 multiple choice questions. Other outcome measurements included participant compliance, participant engagement in Facebook, satisfaction, and self-perceived uses of Facebook for continuing professional education programs.
RESULTS
Significantly more intervention group participants (n=35) completed the study than the control group (n=25) (P<.001). The overall retention rate was 75% (60/80). The mean of changes in scores in the intervention group were significant in all assessments (P<.001). A significant difference in the mean of changes in scores between the two groups was identified in the DKAS subscale Communication and Behavior (95% CI 0.4-3.3, P=.02). There was no significant difference in the total DKAS scores, scores of other DKAS subscales, and multiple choice questions. Participant compliance was significantly higher in the intervention group than in the control group (P<.001). The mean numbers of participants accessing the learning materials were 31.5 (SD 3.9) and 17.6 (SD 5.2) in the intervention and control group, respectively. Polls attracted the highest level of participant engagement, followed by videos. Intervention group participants scored significantly higher in favoring the use of Facebook for the continuing education program (P=.03). Overall, participants were satisfied with the interventions (mean score 4 of a total of 5, SD 0.6).
CONCLUSIONS
The significantly higher retention rate, together with the high levels of participant compliance and engagement, demonstrate that Facebook is a promising tool for professional education. Education delivered through Facebook was significantly more effective at improving participants' knowledge of how people with dementia communicate and behave. Participants demonstrated positive attitudes toward utilizing Facebook for professional learning. These findings provide evidence for the feasibility of using Facebook as an intervention delivery tool in a manner that can be rolled out into practical settings.",2020,Intervention group participants scored significantly higher in favoring the use of Facebook for the continuing education program (P=.03).,"['Eighty health professionals from Hong Kong were recruited for participation in the study and randomized at a 1:1 ratio by a block randomization method to the intervention group (n=40) and control group (n=40', 'patients with dementia', 'Continuous Professional Education on Dementia', 'patients with various conditions']","['8-week educational program developed to deliver updated knowledge on dementia care from a multidisciplinary perspective, either by Facebook (intervention group) or by email (control group', 'continuous professional education program utilizing Facebook', 'Facebook']","['total DKAS scores, scores of other DKAS subscales, and multiple choice questions', 'mean numbers of participants accessing the learning materials', 'mean of changes in scores', 'means of changes in pre- and postintervention scores of knowledge assessments from the 25-item Dementia Knowledge Assessment Scale (DKAS) and formative evaluation of 20 multiple choice questions', 'participant compliance, participant engagement in Facebook, satisfaction, and self-perceived uses of Facebook for continuing professional education programs', 'DKAS subscale Communication and Behavior', 'overall retention rate', 'Participant compliance']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.081195,Intervention group participants scored significantly higher in favoring the use of Facebook for the continuing education program (P=.03).,"[{'ForeName': 'Windy Sy', 'Initials': 'WS', 'LastName': 'Chan', 'Affiliation': 'School of Health Sciences, Caritas Institute of Higher Education, New Territories, China (Hong Kong).'}, {'ForeName': 'Angela Ym', 'Initials': 'AY', 'LastName': 'Leung', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Kowloon, China (Hong Kong).'}]",Journal of medical Internet research,['10.2196/16772']
1074,32487065,Effects of an mHealth voice message service (mMitra) on maternal health knowledge and practices of low-income women in India: findings from a pseudo-randomized controlled trial.,"BACKGROUND
Mobile Health (mHealth) is becoming an important tool to improve health outcomes in maternal, newborn and child health (MNCH). Studies of mHealth interventions, have demonstrated their effectiveness in improving uptake of recommended maternal services such as antenatal visits. However, evidence of impact on maternal health outcomes is still limited.
METHODS
A pseudo-randomized controlled trial (single blind) was conducted to assess the impact of a voice-message based maternal intervention on maternal health knowledge, attitudes, practices and outcomes over time: Pregnancy (baseline/Time 1); Post-partum (Time 2) and when the infant turned one year old (Time 3). Women assigned to the mMitra intervention arm received gestational age- and stage-based educational voice messages via mobile phone in Hindi and Marathi, while those assigned to the control group did not. Both groups received standard care.
RESULTS
Two thousand sixteen women were enrolled. Interviews were conducted with 1516 women in the intervention group and 500 women in the control group at baseline and post-partum. The intervention group performed significantly better than controls on four maternal health practice indicators: receiving the tetanus toxoid injection (OR: 1.6, 95% Confidence Interval (CI): 1.05-2.4, p = 0.028), consulting a doctor if spotting or bleeding (OR: 1.72, 95%CI: 1.07-2.75, p = 0.025), saving money for delivery expenses (OR: 1.79, 95%CI: 1.38-2.33, p = 0.0001), and delivering in hospital (OR: 2.5, 95%CI: 1.49-4.35, p = 0.001). The control group performed significantly better than the intervention group on two practice indicators: resting regularly during pregnancy (OR: 0.7, 95%CI: 0.54-0.88, p = 0.002) and having at-home deliveries attended by a skilled birth attendant (OR: 0.46, 95%CI: 0.23-0.91, p = 0.027). Both groups' knowledge improved from Time 1 to Time 2. Only one knowledge indicator, on seeking medical care during pregnancy, was statistically increased in the intervention group compared to controls. Anemia status at or near the time of delivery was unable to be assessed due to missing data from maternal health cards.
CONCLUSIONS
This study provides evidence that in low-resource settings, mobile voice messages providing tailored and timed information about pregnancy can positively impact maternal health care practices proven to improve maternal health outcomes. Additional research is needed to assess whether voice messaging can motivate behavior change better than text messaging, particularly in low literacy settings.
TRIAL REGISTRATION
The mMitra impact evaluation is registered with ISRCTN under Registration # 88968111, assigned on 6 September 2018 (See https://www.isrctn.com/ISRCTN88968111).",2020,"The control group performed significantly better than the intervention group on two practice indicators: resting regularly during pregnancy (OR: 0.7, 95%CI: 0.54-0.88, p = 0.002) and having at-home deliveries attended by a skilled birth attendant (OR: 0.46, 95%CI: 0.23-0.91, p = 0.027).","['low-income women in India', '1516 women in the intervention group and 500 women in the control group at baseline and post-partum', 'Two thousand sixteen women were enrolled']","['mMitra intervention arm received gestational age- and stage-based educational voice messages via mobile phone in Hindi and Marathi', 'standard care', 'mHealth voice message service (mMitra', 'tetanus toxoid injection', 'voice-message based maternal intervention']","['consulting a doctor if spotting or bleeding', 'maternal health knowledge and practices', 'maternal health knowledge, attitudes, practices and outcomes over time', 'maternal health outcomes', 'saving money for delivery expenses', 'Anemia status']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0019547', 'cui_str': 'Hindi language'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",2016.0,0.207524,"The control group performed significantly better than the intervention group on two practice indicators: resting regularly during pregnancy (OR: 0.7, 95%CI: 0.54-0.88, p = 0.002) and having at-home deliveries attended by a skilled birth attendant (OR: 0.46, 95%CI: 0.23-0.91, p = 0.027).","[{'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Murthy', 'Affiliation': 'Foundation for Research in Health Systems, #G-1, Brigade Business Suites, 10th Main, Jayanagar 2nd Block, Bengaluru, 560011, India.'}, {'ForeName': 'Subhashini', 'Initials': 'S', 'LastName': 'Chandrasekharan', 'Affiliation': 'HealthEnabled, Unit D11 Westlake Square, Westlake Drive, Westlake, Cape Town, 7945, South Africa.'}, {'ForeName': 'Muthu Perumal', 'Initials': 'MP', 'LastName': 'Prakash', 'Affiliation': 'Foundation for Research in Health Systems, G2, 5/26 Pillayar Kovil Street, Medavakkam, Chennai, 600100, India.'}, {'ForeName': 'Aakash', 'Initials': 'A', 'LastName': 'Ganju', 'Affiliation': 'Saat Health, 1103, Glencroft, Hiranandani Gardens, Powai, Mumbai, 400076, India.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Peter', 'Affiliation': 'Johnson & Johnson, 241 Main Road, Retreat, Cape Town, 7945, South Africa.'}, {'ForeName': 'Nadi', 'Initials': 'N', 'LastName': 'Kaonga', 'Affiliation': 'HealthEnabled, Unit D11 Westlake Square, Westlake Drive, Westlake, Cape Town, 7945, South Africa.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Mechael', 'Affiliation': 'HealthEnabled, Unit D11 Westlake Square, Westlake Drive, Westlake, Cape Town, 7945, South Africa. pmechael@gmail.com.'}]",BMC public health,['10.1186/s12889-020-08965-2']
1075,32580710,"Fasting in diabetes treatment (FIT) trial: study protocol for a randomised, controlled, assessor-blinded intervention trial on the effects of intermittent use of a fasting-mimicking diet in patients with type 2 diabetes.","BACKGROUND
Caloric restriction is an effective way to treat Type 2 diabetes (T2D). However, chronic and severe restriction of food intake is difficult to sustain and is known to promote slower metabolism. Intermittent and frequent fasting can exert similar metabolic effects, but may be even more challenging for most patients. A fasting-mimicking diet (FMD) is low in calories, sugars and proteins, but includes relatively high levels of plant based complex carbohydrates and healthy fats. The metabolic effects of such a diet mimic the benefits of water-only fasting. The effects of a FMD applied periodically in T2D patients are still unknown. The Fasting In diabetes Treatment (FIT) trial was designed to determine the effect of intermittent use (5 consecutive days a month during a year) of a FMD in T2D patients on metabolic parameters and T2D medication use compared to usual care.
METHODS
One hundred T2D patients from general practices in the Netherlands with a BMI ≥ 27 kg/m 2 , treated with lifestyle advice only or lifestyle advice plus metformin, will be randomised to receive the FMD plus usual care or usual care only. Primary outcomes are HbA1c and T2D medication dosage. Secondary outcomes are anthropometrics, blood pressure, plasma lipid profiles, quality of life, treatment satisfaction, metabolomics, microbiome composition, MRI data including cardiac function, fat distribution and ectopic fat storage, cost-effectiveness, and feasibility in clinical practice.
DISCUSSION
This study will establish whether monthly 5-day cycles of a FMD during a year improve metabolic parameters and/or reduce the need for medication in T2D. Furthermore, additional health benefits and the feasibility in clinical practice will be measured and a cost-effectiveness evaluation will be performed.
TRIAL REGISTRATION
The trial was registered on ClinicalTrials.gov. Identifier: NCT03811587. Registered 21th of January, 2019; retrospectively registered.",2020,This study will establish whether monthly 5-day cycles of a FMD during a year improve metabolic parameters and/or reduce the need for medication in T2D.,"['T2D patients from general practices in the Netherlands with a BMI\u2009≥\u200927\u2009kg/m 2 , treated with', 'T2D patients', 'One hundred', 'patients with type 2 diabetes']","['fasting-mimicking diet', 'lifestyle advice only or lifestyle advice plus metformin', 'FMD plus usual care or usual care only', 'FMD']","['anthropometrics, blood pressure, plasma lipid profiles, quality of life, treatment satisfaction, metabolomics, microbiome composition, MRI data including cardiac function, fat distribution and ectopic fat storage, cost-effectiveness, and feasibility in clinical practice', 'HbA1c and T2D medication dosage', 'Fasting']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",100.0,0.101727,This study will establish whether monthly 5-day cycles of a FMD during a year improve metabolic parameters and/or reduce the need for medication in T2D.,"[{'ForeName': 'Elske L', 'Initials': 'EL', 'LastName': 'van den Burg', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands. e.l.van_den_burg@lumc.nl.'}, {'ForeName': 'Marjolein P', 'Initials': 'MP', 'LastName': 'Schoonakker', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Petra G', 'Initials': 'PG', 'LastName': 'van Peet', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'M Elske', 'Initials': 'ME', 'LastName': 'van den Akker-van Marle', 'Affiliation': 'Department of Biomedical Data Sciences, Medical Decision Making, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Willems van Dijk', 'Affiliation': 'Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Valter D', 'Initials': 'VD', 'LastName': 'Longo', 'Affiliation': 'FIRC Institute of Molecular Oncology, Milan, Italy.'}, {'ForeName': 'Hildo J', 'Initials': 'HJ', 'LastName': 'Lamb', 'Affiliation': 'Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Mattijs E', 'Initials': 'ME', 'LastName': 'Numans', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Pijl', 'Affiliation': 'Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}]",BMC endocrine disorders,['10.1186/s12902-020-00576-7']
1076,32586079,Effect of Tai Chi exercise with the same frequency and different exercise duration on the bone mineral density of older women.,"BACKGROUND
This study compared the effect of Tai Chi with the same frequency and different session duration on the bone mineral density (BMD) of older women.
METHODS
Healthy older women aged 55-70 years were randomly divided into the short-time group (N.=17), long-time group (N.=18), and control group (N.=17). The BMD of L2-4 and the proximal femur were measured at baseline and after 48 weeks of intervention.
RESULTS
From 0 to 48 weeks, the respective BMD values of L2-4 and the femoral neck in the short-time and long-time groups increased by 8.8% and 7.5% (P<0.01) and 8.8% and 12.7% (P<0.01), while the BMD of the greater trochanter in the control group decreased by 3.0% (P<0.05). After 48 weeks, the BMD of L2-4 and the femoral neck was greater in the short-time and long-time groups than the control group (P<0.001).
CONCLUSIONS
Tai Chi for 30 or 60 minutes five times weekly for 48 weeks improves the BMD of L2-4 and the femoral neck in older women but does not affect the BMD of the greater trochanter and Ward's triangle. Increasing the exercise duration does not increase the effect of Tai Chi on BMD.",2020,"After 48 weeks, the BMD of L2-4 and the femoral neck was greater in the short-time and long-time groups than the control group (P<0.001).
","['older women', 'Healthy older women aged 55-70 years']","['Tai Chi', 'Tai Chi exercise']","['BMD of L2-4 and the femoral neck', 'BMD of the greater trochanter', 'BMD of L2-4 and the proximal femur', 'bone mineral density (BMD', 'respective BMD values of L2-4 and the femoral neck']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0223865', 'cui_str': 'Structure of greater trochanter of femur'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0408978,"After 48 weeks, the BMD of L2-4 and the femoral neck was greater in the short-time and long-time groups than the control group (P<0.001).
","[{'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Ba', 'Affiliation': '- 380320557@qq.com.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10940-X']
1077,32584620,Evaluation of the Effectiveness of Psychoeducation Given to Children with Parental Psychiatric Disorders.,"This study was aimed to determine the effectiveness of psychoeducation program which was developed to improve the coping skills and to increase the psychological resistance of 12-18 years children/adolescents whose parents' have psychiatric disorders. The study was carried out between May 2018 - November 2019 with children of patients who applied to the outpatient clinic and inpatient treatment at Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine Department of Psychiatry. Total of 40 children (experiment = 20 and control = 20), participated in the study. Data were collected using Personal Information Form, Adolescent Psychological Resilience Scale and Kidcope. The mean age of the children/adolescents in the experimental group was 14.05 ± 1.90, 50% was male and the mean age of the control group was 15.35 ± 2.08, and 55% were male. It was determined that the mean duration of psychiatric disorders were 11.50 ± 6.39 years and 40% of the psychiatric diagnosis was schizophrenia in the experimental group, and the mean duration psychiatric disorders were 6.10 ± 5.16 years and 30% of the psychiatric diagnosis was a depression in the control group. After psychoeducation, the total scores of scales in the experimental group showed an increase compared to the control group and a significant difference in a statistical context. It was found that children/adolescents participating in the psychoeducation program had increased psychological resilience levels and improved coping skills. This result shows that the psychoeducation program for children/adolescents with psychiatric disorders in their parents is effective.",2020,It was found that children/adolescents participating in the psychoeducation program had increased psychological resilience levels and improved coping skills.,"['mean age of the children/adolescents in the experimental group was 14.05\u2009±\u20091.90, 50% was male and the mean age of the control group was 15.35\u2009±\u20092.08, and 55% were male', 'May 2018 - November 2019 with children of patients who applied to the outpatient clinic and inpatient treatment at Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine Department of Psychiatry', 'Children with Parental Psychiatric Disorders', ""12-18 years children/adolescents whose parents' have psychiatric disorders"", 'children/adolescents with psychiatric disorders', 'Total of 40 children (experiment = 20 and control = 20), participated in the study']","['Psychoeducation', 'psychoeducation program']","['total scores of scales', 'coping skills', 'mean duration psychiatric disorders', 'mean duration of psychiatric disorders', 'psychological resistance', 'psychological resilience levels and improved coping skills']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517626', 'cui_str': '2.08'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",40.0,0.0221932,It was found that children/adolescents participating in the psychoeducation program had increased psychological resilience levels and improved coping skills.,"[{'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Küçük', 'Affiliation': 'Department of Mental Health and Psychiatric Nursing, Florence Nightingale Faculty of Nursing, Istanbul University - Cerrahpasa, Şişli-Istanbul, Turkey.'}, {'ForeName': 'Hülya', 'Initials': 'H', 'LastName': 'Bilgin', 'Affiliation': 'Department of Mental Health and Psychiatric Nursing, Florence Nightingale Faculty of Nursing, Istanbul University - Cerrahpasa, Şişli-Istanbul, Turkey.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Çömez Ikican', 'Affiliation': 'Department of Mental Health and Psychiatric Nursing, Institute of Graduate Education, Istanbul University - Cerrahpasa, Avcılar-Istanbul, Turkey.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Kaçar', 'Affiliation': 'Department of Psychiatry, Cerrahpasa Faculty of Medicine, Istanbul University - Cerrahpasa, Kocamustafapaşa-İstanbul, Turkey.'}, {'ForeName': 'Muhammed Tayyip', 'Initials': 'MT', 'LastName': 'Kadak', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Cerrahpasa Faculty of Medicine, Istanbul University - Cerrahpasa, Kocamustafapaşa-İstanbul, Turkey.'}, {'ForeName': 'Ömer Faruk', 'Initials': 'ÖF', 'LastName': 'Demirel', 'Affiliation': 'Department of Psychiatry, Cerrahpasa Faculty of Medicine, Istanbul University - Cerrahpasa, Kocamustafapaşa-İstanbul, Turkey.'}, {'ForeName': 'Vahdi', 'Initials': 'V', 'LastName': 'Çoban', 'Affiliation': 'Department of Psychiatry, Cerrahpasa Faculty of Medicine, Istanbul University - Cerrahpasa, Kocamustafapaşa-İstanbul, Turkey.'}, {'ForeName': 'Fatma Yasemin', 'Initials': 'FY', 'LastName': 'Kutlu', 'Affiliation': 'Department of Mental Health and Psychiatric Nursing, Florence Nightingale Faculty of Nursing, Istanbul University - Cerrahpasa, Şişli-Istanbul, Turkey.'}, {'ForeName': 'Cana', 'Initials': 'C', 'LastName': 'Aksoy Poyraz', 'Affiliation': 'Department of Psychiatry, Cerrahpasa Faculty of Medicine, Istanbul University - Cerrahpasa, Kocamustafapaşa-İstanbul, Turkey.'}, {'ForeName': 'Sevim', 'Initials': 'S', 'LastName': 'Buzlu', 'Affiliation': 'Department of Mental Health and Psychiatric Nursing, Florence Nightingale Faculty of Nursing, Istanbul University - Cerrahpasa, Şişli-Istanbul, Turkey.'}, {'ForeName': 'Alaattin', 'Initials': 'A', 'LastName': 'Duran', 'Affiliation': 'Department of Psychiatry, Cerrahpasa Faculty of Medicine, Istanbul University - Cerrahpasa, Kocamustafapaşa-İstanbul, Turkey.'}]",Issues in mental health nursing,['10.1080/01612840.2020.1756010']
1078,32590831,Long-Axis In-Plane Approach Versus Short-Axis Out-of-Plane Approach for Ultrasound-Guided Central Venous Catheterization in Pediatric Patients: A Randomized Controlled Trial.,"OBJECTIVES
The aim of this study was to compare the occurrence of posterior wall puncture between the long-axis in-plane and the short-axis out-of-plane approaches in a randomized controlled trial of pediatric patients who underwent cardiovascular surgery under general anesthesia.
DESIGN
Prospective randomized controlled trial.
SETTING
Operating room of Osaka Women's and Children's Hospital.
PATIENTS
Pediatric patients less than 5 years old who underwent cardiovascular surgery.
INTERVENTIONS
Ultrasound-guided central venous catheterization using the long-axis in-plane approach and short-axis out-of-plane approach.
MEASUREMENTS AND MAIN RESULTS
The occurrence of posterior wall puncture was compared between the long-axis in-plane and short-axis out-of-plane approaches for ultrasound-guided central venous catheterization. Patients were randomly allocated to a long-axis group or a short-axis group and underwent ultrasound-guided central venous catheterization in the internal jugular vein using either the long-axis in-plane approach (long-axis group) or the short-axis out-of-plane approach (short-axis group). After exclusion, 97 patients were allocated to the long-axis (n = 49) or short-axis (n = 48) groups. Posterior wall puncture rates were 8.2% (4/49) and 39.6% (19/48) in the long-axis and short-axis groups, respectively (relative risk, 0.21; 95% CI, 0.076-0.56; p = 0.0003). First attempt success rates were 67.3% (33/49) and 64.6% (31/48) in the long-axis and short-axis groups, respectively (relative risk, 1.04; 95% CI, 0.78-1.39; p = 0.77). Overall success rates within 20 minutes were 93.9% (46/49) and 93.8% (45/48) in the long-axis and short-axis groups, respectively (relative risk, 0.99; 95% CI, 0.90-1.11; p = 0.98).
CONCLUSIONS
The long-axis in-plane approach for ultrasound-guided central venous catheterization is a useful technique for avoiding posterior wall puncture in pediatric patients, compared with the short-axis out-of-plane approach.",2020,"Posterior wall puncture rates were 8.2% (4/49) and 39.6% (19/48) in the long-axis and short-axis groups, respectively (relative risk, 0.21; 95% CI, 0.076-0.56; p = 0.0003).","['97 patients were allocated to the long-axis (n = 49) or short-axis (n = 48) groups', ""Operating room of Osaka Women's and Children's Hospital"", 'pediatric patients', 'Pediatric Patients', 'pediatric patients who underwent cardiovascular surgery under general anesthesia', 'Pediatric patients less than 5 years old who underwent cardiovascular surgery']","['long-axis group or a short-axis group and underwent ultrasound-guided central venous catheterization in the internal jugular vein using either the long-axis in-plane approach (long-axis group) or the short-axis out-of-plane approach (short-axis group', 'Plane Approach Versus Short-Axis Out-of-Plane Approach for Ultrasound-Guided Central Venous Catheterization', 'Ultrasound-guided central venous catheterization using the long-axis in-plane approach and short-axis out-of-plane approach', 'ultrasound-guided central venous catheterization']","['occurrence of posterior wall puncture', 'success rates', 'Overall success rates', 'Posterior wall puncture rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0522488', 'cui_str': 'Short axis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0038897', 'cui_str': 'Cardiovascular surgical procedure'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0522488', 'cui_str': 'Short axis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0007435', 'cui_str': 'Central venous catheterisation'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",97.0,0.0729776,"Posterior wall puncture rates were 8.2% (4/49) and 39.6% (19/48) in the long-axis and short-axis groups, respectively (relative risk, 0.21; 95% CI, 0.076-0.56; p = 0.0003).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takeshita', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Tachibana', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Nakajima', 'Affiliation': 'Department of Anesthesiology, Kansai Medical University Hospital, Hirakata, Osaka, Japan.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Nagai', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Fujiwara', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Hamaba', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Matsuura', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Shime', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Institute of Biomedical & Health Sciences, Hiroshima University, Minami-ku, Hiroshima, Japan.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002476']
1079,32592633,Effects of Multiple-Dose Administration of Aprocitentan on the Pharmacokinetics of Rosuvastatin.,"Aprocitentan is an investigational, orally active, dual, endothelin receptor antagonist that targets a novel pathway in the treatment of difficult-to-control (resistant) hypertension. The drug-drug interaction potential of aprocitentan on the breast cancer resistance protein (BCRP) transporter substrate rosuvastatin was investigated in this single-center, open-label, single-sequence study. Twenty healthy male subjects received a single dose of 10-mg rosuvastatin on days 1 and 13 followed by pharmacokinetic and tolerability assessments for up to 120 hours. From day 5 to day 17, subjects received 25 mg of aprocitentan once daily. Seventeen of 20 enrolled subjects completed the treatment. At steady state, aprocitentan did not affect the pharmacokinetics of rosuvastatin in a clinically relevant way. The maximum plasma concentration was increased by 40% with a 90% confidence interval of 1.19 to 1.65. However, the ratio of the geometric means for both area under the plasma concentration-time curve from time 0 to time t and area under the plasma concentration-time curve from time 0 to infinity was close to 1 with the 90% confidence interval within a reference interval of 0.80 to 1.25. Adverse events leading to study discontinuation were reported in 2 subjects. Overall, the combination of rosuvastatin and aprocitentan was well tolerated. Based on these data, aprocitentan does not affect BCRP and can be administered concomitantly with drugs dependent on BCRP transport.",2020,The maximum plasma concentration was increased by 40% with a 90% confidence interval of 1.19 to 1.65.,"['Seventeen of 20 enrolled subjects completed the treatment', 'Twenty healthy male subjects']","['10-mg rosuvastatin', 'rosuvastatin', 'Rosuvastatin']","['maximum plasma concentration', 'tolerated']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",20.0,0.0227631,The maximum plasma concentration was increased by 40% with a 90% confidence interval of 1.19 to 1.65.,"[{'ForeName': 'Patricia N', 'Initials': 'PN', 'LastName': 'Sidharta', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.815']
1080,32600745,The effect of residual bone height and membrane thickness on sinus membrane perforation in crestal sinus grafting: A prospective clinical study.,"This study sought to determine the rate of sinus membrane perforation in patients undergoing crestal sinus grafting, as well as the effect of Schneiderian membrane thickness and residual bone height (RBH) on membrane perforation, using cone beam computed tomography. The study included 25 patients undergoing 44 crestal sinus grafting procedures. The sites for crestal sinus grafting were divided into a control group (RBH≥5mm) and a test group (RBH<5mm). All sinus grafting procedures were also categorised based on membrane thickness: group A (<1mm), group B (1-2mm), and group C (≥2mm). The rate of membrane perforation was 18.2%. The median RBH measurement was 5.59mm. No statistically significant difference in membrane perforation rate was found between the test and control groups (P=0.262). The median thickness of the Schneiderian membrane was 1.35mm. There was no statistically significant difference in membrane perforation among the three membrane thickness groups (P=0.431). No significant correlation between RBH and membrane perforation was observed, although clinical observation indicated that there was a tendency for an increased membrane perforation rate in the presence of a RBH<5mm. The perforation rate was found to be at its highest when the membrane was thinner than 1mm.",2020,No statistically significant difference in membrane perforation rate was found between the test and control groups (P=0.262).,"['crestal sinus grafting', 'patients undergoing crestal sinus grafting', '25 patients undergoing 44 crestal sinus grafting procedures']",['residual bone height and membrane thickness'],"['membrane perforation', 'membrane perforation rate', 'rate of membrane perforation', 'median RBH measurement', 'median thickness of the Schneiderian membrane', 'RBH and membrane perforation', 'perforation rate', 'rate of sinus membrane perforation']","[{'cui': 'C2236586', 'cui_str': 'Sinus augmentation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C4704901', 'cui_str': 'Schneiderian Membrane'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}]",25.0,0.0144395,No statistically significant difference in membrane perforation rate was found between the test and control groups (P=0.262).,"[{'ForeName': 'D Uçar', 'Initials': 'DU', 'LastName': 'Boyacıgil', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Mamak Oral and Dental Health Hospital, Ankara, Turkey.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Er', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Ç', 'Initials': 'Ç', 'LastName': 'Karaca', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hacettepe University, Ankara, Turkey. Electronic address: cigdem.karaca@hacettepe.edu.tr.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Koç', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hacettepe University, Ankara, Turkey.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2020.05.018']
1081,31389889,"Does Robotic-assisted TKA Result in Better Outcome Scores or Long-Term Survivorship Than Conventional TKA? A Randomized, Controlled Trial.","BACKGROUND
Robotic-assisted TKA was introduced to enhance the precision of bone preparation and component alignment with the goal of improving the clinical results and survivorship of TKA. Although numerous reports suggest that bone preparation and knee component alignment may be improved using robotic assistance, no long-term randomized trials of robotic-assisted TKA have shown whether this results in improved clinical function or survivorship of the TKA.
QUESTIONS/PURPOSES
In this randomized trial, we compared robotic-assisted TKA to manual-alignment techniques at long-term follow-up in terms of (1) functional results based on Knee Society, WOMAC, and UCLA Activity scores; (2) numerous radiographic parameters, including component and limb alignment; (3) Kaplan-Meier survivorship; and (4) complications specific to robotic-assistance, including pin-tract infection, peroneal nerve palsy, pin-site fracture, or patellar complications.
METHODS
This study was a registered prospective, randomized, controlled trial. From January 2002 to February 2008, one surgeon performed 975 robotic-assisted TKAs in 850 patients and 990 conventional TKAs in 849 patients. Among these patients 1406 patients were eligible for participation in this study based on prespecified inclusion criteria. Of those, 100% (1406) patients agreed to participate and were randomized, with 700 patients (750 knees) receiving robotic-assisted TKA and 706 patients (766 knees) receiving conventional TKA. Of those, 96% (674 patients) in the robotic-assisted TKA group and 95% (674 patients) in the conventional TKA group were available for follow-up at a mean of 13 (± 5) years. In both groups, no patient older than 65 years was randomized because we anticipated long-term follow-up. We evaluated 674 patients (724 knees) in each group for clinical and radiographic outcomes, and we examined Kaplan-Meier survivorship for the endpoint of aseptic loosening or revision. Clinical evaluation was performed using the original Knee Society knee score, the WOMAC score, and the UCLA activity score preoperatively and at latest follow-up visit. We also assessed loosening (defined as change in the position of the components) using plain radiographs, osteolysis using CT scans at the latest follow-up visit, and component, and limb alignment on mechanical axis radiographs.To minimize the chance of type-2 error and increase the power of our study, we assumed the difference in the Knee Society score to be 5 points to match the MCID of the Knee Society with power of 0.99, which revealed that a total of 628 patients would be needed in each group.
RESULTS
Clinical parameters at the latest follow-up including the Knee Society knee scores (93 ± 5 points in the robotic-assisted TKA group versus 92 ± 6 points in the conventional TKA group [95% confidence interval 90 to 98]; p = 0.321) and Knee Society knee function scores (83 ± 7 points in the robotic-assisted TKA group versus 85 ± 6 points in the conventional TKA group [95% CI 75 to 88]; p = 0.992), WOMAC scores (18 ± 14 points in the robotic-assisted TKA group versus 19 ± 15 points in the conventional TKA group [95% CI 16 to 22]; p = 0.981), range of knee motion (125 ± 6° in the robotic-assisted TKA group versus 128 ± 7° in the conventional TKA group [95% CI 121 to 135]; p = 0.321), and UCLA patient activity scores (7 points versus 7 points in each group [95% CI 5 to 10]; p = 1.000) were not different between the two groups at a mean of 13 years' follow-up. Radiographic parameters such as the femorotibial angle (mean 2° ± 2° valgus in the robotic-assisted TKA group versus 3° ± 3° valgus in the conventional TKA group [95% CI 1 to 5]; p = 0.897), femoral component position (coronal plane: mean 98° in the robotic-assisted TKA group versus 97° in the conventional TKA group [95% CI 96 to 99]; p = 0.953; sagittal plane: mean 3° in the robotic-assisted TKA group versus 2° in the conventional TKA group [95% CI 1 to 4]; p = 0.612) and tibial component position (coronal plane: mean 90° in the robotic-assisted TKA group versus 89° in the conventional TKA group [95% CI 87 to 92]; p = 0.721; sagittal plane: 87° in the robotic-assisted TKA group versus 86° in the conventional TKA group [95% CI 84 to 89]; p = 0.792), joint line (16 mm in the robotic-assisted TKA group versus 16 mm in the conventional TKA group [95% CI 14 to 18]; p = 0.512), and posterior femoral condylar offset (24 mm in the robotic-assisted TKA group versus 24 mm in the conventional TKA group [95% CI 21 to 27 ]; p = 0.817) also were not different between the two groups (p > 0.05). The aseptic loosening rate was 2% in each group, and this was not different between the two groups. With the endpoint of revision or aseptic loosening of the components, Kaplan-Meier survivorship of the TKA components was 98% in both groups (95% CI 94 to 100) at 15 years (p = 0.972). There were no between-group differences in terms of the frequency with which complications occurred. In each group, 2% of knees (15) had a superficial infection treated with intravenous antibiotics for 2 weeks. No deep infection occurred in these knees. In the conventional TKA group, 0.8% of knees (six) had a motion limitation (< 60°).
CONCLUSIONS
At a minimum follow-up of 10 years, we found no differences between robotic-assisted TKA and conventional TKA in terms of functional outcome scores, aseptic loosening, overall survivorship, and complications. Considering the additional time and expense associated with robotic-assisted TKA, we cannot recommend its widespread use.
LEVEL OF EVIDENCE
Level I, therapeutic study.",2020,"At a minimum follow-up of 10 years, we found no differences between robotic-assisted TKA and conventional TKA in terms of functional outcome scores, aseptic loosening, overall survivorship, and complications.","['Of those, 100% (1406) patients agreed to participate and were randomized, with 700 patients (750 knees) receiving', 'and 706 patients (766 knees) receiving', 'in 850 patients and 990 conventional TKAs in 849 patients', 'patients 1406 patients were eligible for participation in this study based on prespecified inclusion criteria', '674 patients (724 knees) in each group for clinical and radiographic outcomes, and we examined Kaplan-Meier survivorship for the endpoint of aseptic loosening or revision']","['conventional TKA', 'tibial component position (coronal plane: mean', 'intravenous antibiotics', '975 robotic-assisted TKAs', 'Robotic-assisted TKA', 'robotic-assisted TKA']","['posterior femoral condylar offset', 'revision or aseptic loosening of the components, Kaplan-Meier survivorship of the TKA components', 'original Knee Society knee score, the WOMAC score, and the UCLA activity score', 'UCLA patient activity scores', 'aseptic loosening rate', 'Knee Society, WOMAC, and UCLA Activity scores; (2) numerous radiographic parameters, including component and limb alignment; (3) Kaplan-Meier survivorship; and (4) complications specific to robotic-assistance, including pin-tract infection, peroneal nerve palsy, pin-site fracture, or patellar complications', 'WOMAC scores', 'femoral component position', 'Knee Society knee scores', 'range of knee motion', 'Knee Society knee function scores', 'functional outcome scores, aseptic loosening, overall survivorship, and complications', 'deep infection']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C4517916', 'cui_str': '990'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C4517911', 'cui_str': '975'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0232920', 'cui_str': 'Sterile'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0270810', 'cui_str': 'Peroneal nerve palsy'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0449434', 'cui_str': 'Femoral component'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",1406.0,0.114253,"At a minimum follow-up of 10 years, we found no differences between robotic-assisted TKA and conventional TKA in terms of functional outcome scores, aseptic loosening, overall survivorship, and complications.","[{'ForeName': 'Young-Hoo', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Y.-H. Kim, The Joint Replacement Center, Seoul Metropolitan SeoNam Hospital, Seoul, Republic of Korea S.-H. Yoon, The Joint Replacement Center, Lee Chun Teck Hospital, Suwon, Seoul, Republic of Korea J.-W. Park, The Joint Replacement Center, Ewha Womans University Ewha Seoul Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sung-Hwan', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': ''}, {'ForeName': 'Jang-Won', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000916']
1082,32608120,Effect of recorded maternal voice on emergence agitation in children undergoing bilateral ophthalmic surgery: A randomised controlled trial.,"AIM
This study was designed to investigate whether the playing-back of the recorded maternal voice through the headphones to children undergoing bilateral ophthalmic surgery has clinical effects on the incidence of emergence agitation, and the anaesthesia recovery course.
METHODS
In this prospective, blinded and randomised study, 127 children, aged 2-8 years and undergoing bilateral ophthalmic surgery were randomly allocated to one of the two groups: group T (treatment group, listening to recorded mother's voice via headphones) or group C (control group, wearing headphones without auditory stimuli). The primary outcome was the incidence of emergence agitation, and the secondary outcomes were the awakening time, and the post-anaesthesia care unit (PACU) stay time.
RESULTS
Children in the group of listening recorded mother's voice exhibited significantly low incidence of emergence agitation compared with those in the control group (32.8 vs. 55.6%; odds ratio (95% confidence interval): 0.39(0.19-0.80); P = 0.010). The awakening time was shorter in group T as compared to that in group C (22.9 (10.4) vs. 27.3 (13.7); P = 0.048). As results, the group T had significantly less PACU stay time with early discharge than the group C did (29.7 (12.1) vs. 34.8 (14.1); P = 0.031).
CONCLUSIONS
Recorded mother's voice is an efficient method to reduce emergence agitation in children undergoing bilateral ophthalmic surgery with sevoflurane anaesthesia. Also, patients woke faster and PACU stay time was shorter in the mother's voice group as compared with the control group.",2020,The awakening time was shorter in group T as compared to that in group C (22.9 (10.4) vs. 27.3 (13.7); P = 0.048).,"['children undergoing bilateral ophthalmic surgery', '127 children, aged 2-8\u2009years and undergoing bilateral ophthalmic surgery', 'children undergoing bilateral ophthalmic surgery with sevoflurane anaesthesia']","[""group T (treatment group, listening to recorded mother's voice via headphones) or group C (control group, wearing headphones without auditory stimuli"", 'recorded maternal voice']","['awakening time, and the post-anaesthesia care unit (PACU) stay time', 'emergence agitation', 'awakening time', 'PACU stay time with early discharge', 'PACU stay time', 'incidence of emergence agitation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0441067', 'cui_str': 'Earphones'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}]","[{'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",127.0,0.285404,The awakening time was shorter in group T as compared to that in group C (22.9 (10.4) vs. 27.3 (13.7); P = 0.048).,"[{'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Ma-Zhong', 'Initials': 'MZ', 'LastName': 'Zhang', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Zhe-Zhe', 'Initials': 'ZZ', 'LastName': 'Peng', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Pei-Pei', 'Initials': 'PP', 'LastName': 'Liu', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Yan-Ting', 'Initials': 'YT', 'LastName': 'Wang', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Ji-Jian', 'Initials': 'JJ', 'LastName': 'Zheng', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Jun-Zheng', 'Initials': 'JZ', 'LastName': 'Wu', 'Affiliation': ""Department of Anaesthesia and Paediatrics, Cincinnati Children's Hospital Medical Centre, Cincinnati, Ohio, United States.""}]",Journal of paediatrics and child health,['10.1111/jpc.14948']
1083,32609011,Renin and Survival in Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock. A Clinical Trial.,"Rationale: Exogenous angiotensin II increases mean arterial pressure in patients with catecholamine-resistant vasodilatory shock (CRVS). We hypothesized that renin concentrations may identify patients most likely to benefit from such therapy. Objectives: To test the kinetic changes in renin concentrations and their prognostic value in patients with CRVS. Methods: We analyzed serum samples from patients enrolled in the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) trial for renin, angiotensin I, and angiotensin II concentrations before the start of administration of angiotensin II or placebo and after 3 hours. Measurements and Main Results: Baseline serum renin concentration (normal range, 2.13-58.78 pg/ml) was above the upper limits of normal in 194 of 255 (76%) study patients with a median renin concentration of 172.7 pg/ml (interquartile range [IQR], 60.7 to 440.6 pg/ml), approximately threefold higher than the upper limit of normal. Renin concentrations correlated positively with angiotensin I/II ratios ( r = 0.39; P < 0.001). At 3 hours after initiation of angiotensin II therapy, there was a 54.3% reduction (IQR, 37.9% to 66.5% reduction) in renin concentration compared with a 14.1% reduction (IQR, 37.6% reduction to 5.1% increase) with placebo ( P < 0.0001). In patients with renin concentrations above the study population median, angiotensin II significantly reduced 28-day mortality to 28 of 55 (50.9%) patients compared with 51 of 73 patients (69.9%) treated with placebo (unstratified hazard ratio, 0.56; 95% confidence interval, 0.35 to 0.88; P = 0.012) ( P = 0.048 for the interaction). Conclusions: The serum renin concentration is markedly elevated in CRVS and may identify patients for whom treatment with angiotensin II has a beneficial effect on clinical outcomes.Clinical trial registered with www.clinicaltrials.gov (NCT02338843).",2020,Renin levels correlated positively with angiotensin I/angiotensin II ratios (r =.39; P<0.001).,"['CRVS patients', 'patients with catecholamine-resistant vasodilatory shock (CRVS', 'Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock', 'patients enrolled in the Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) trial for renin, angiotensin I, and angiotensin II levels prior to the start of administration of']","['placebo', 'angiotensin', 'angiotensin II therapy', 'angiotensin II or placebo']","['renin levels', 'Renin and Survival', 'Renin levels', 'renin concentration', 'Baseline serum renin concentration', '28-day mortality', 'mean arterial pressure', 'median renin concentration', 'Serum renin concentration']","[{'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003006', 'cui_str': 'Angiotensin I'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.111806,Renin levels correlated positively with angiotensin I/angiotensin II ratios (r =.39; P<0.001).,"[{'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Centre for Integrated Critical Care, Department of Medicine & Radiology, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lui G', 'Initials': 'LG', 'LastName': 'Forni', 'Affiliation': 'Intensive Care Unit, Royal Surrey Hospital Foundation Trust, Guildford, United Kingdom.'}, {'ForeName': 'Laurence W', 'Initials': 'LW', 'LastName': 'Busse', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, and.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'McCurdy', 'Affiliation': 'Division of Pulmonary & Critical Care Medicine, School of Medicine, University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Kealy R', 'Initials': 'KR', 'LastName': 'Ham', 'Affiliation': 'Department of Critical Care, Regions Hospital, University of Minnesota, St. Paul, Minnesota.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boldt', 'Affiliation': 'Division of Critical Care, Department of Anesthesiology and Perioperative Medicine, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'Division of Intensive Care Medicine, Department of Perioperative, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Department of Anesthesiology, Section on Critical Care Medicine, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Albertson', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, School of Medicine, University of California-Davis, Northern California Health System, Mather, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tumlin', 'Affiliation': 'Renal Division, Department of Medicine, Emory University Medical Center, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Storey', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, California.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Handisides', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, California.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Tidmarsh', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, California.'}, {'ForeName': 'Lakhmir S', 'Initials': 'LS', 'LastName': 'Chawla', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, California.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""Department of Critical Care, Guy's & St. Thomas' Hospital, King's College London, London, United Kingdom.""}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201911-2172OC']
1084,32609069,Comparison of two forced-air warming devices during foot and ankle surgery: a randomised controlled trial.,"Inadvertent perioperative hypothermia is a frequent problem associated with surgical patients which can have significant consequences during surgery and in the immediate postoperative period. We compared 35 randomised patients using over vs. under body forced air heating. There were no statistically significant differences between some demographic and surgical parameters such as: age, weight, height, body mass index, length of anaesthesia and operation. Statistically significant differences were found between the patient's admission to the operating room and 30 minutes and the end of the procedure on the under body patients group. This study analyses a uniform population of patients (Foot and Ankle Surgery) previously not studied and supports the use of under body blankets.",2020,"There were no statistically significant differences between some demographic and surgical parameters such as: age, weight, height, body mass index, length of anaesthesia and operation.","['35 randomised patients using over vs. under body forced air heating', 'during foot and ankle surgery']",['two forced-air warming device'],"['age, weight, height, body mass index, length of anaesthesia and operation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0188412', 'cui_str': 'Operative procedure on ankle'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",35.0,0.0509046,"There were no statistically significant differences between some demographic and surgical parameters such as: age, weight, height, body mass index, length of anaesthesia and operation.","[{'ForeName': 'Jorge Javier Del', 'Initials': 'JJD', 'LastName': 'Vecchio', 'Affiliation': 'Head Foot and Ankle Section, Orthopaedics Department, Hospital Universitario - Fundación Favaloro, Ciudad Autónoma de Buenos Aires (CABA), Argentina.'}, {'ForeName': 'Lucas Nicolás', 'Initials': 'LN', 'LastName': 'Chemes', 'Affiliation': 'Department of Kinesiology and Physiatry, Universidad Favaloro, Buenos Aires, Argentina.'}, {'ForeName': 'Mauricio Esteban', 'Initials': 'ME', 'LastName': 'Ghioldi', 'Affiliation': 'Department of Kinesiology and Physiatry, Universidad Favaloro, Buenos Aires, Argentina.'}, {'ForeName': 'Eric Daniel', 'Initials': 'ED', 'LastName': 'Dealbera', 'Affiliation': 'Foot and Ankle Section, Fundación Favaloro - Hospital Universitario, Buenos Aires, Argentina.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Daniel Morgillo', 'Affiliation': 'Foot and Ankle Surgery and Limb Salvage Fellowship, Foot and Ankle Section, Fundación Favaloro - Hospital Universitario, Buenos Aires, Argentina.'}]",Journal of perioperative practice,['10.1177/1750458920927286']
1085,32571327,Twelve months of exercise training did not halt abdominal aortic calcification in patients with CKD - a sub-study of RENEXC-a randomized controlled trial.,"BACKGROUND
Arteriosclerosis is prevalent in patients with chronic kidney disease (CKD). Our aims were to investigate (1) the effects of 12 months of either balance- or strength- both in combination with endurance training on abdominal aortic calcification (AAC); on some lipids and calcific- and inflammatory markers; and (2) the relationships between the change in AAC score and these markers in non-dialysis dependent patients with CKD stages 3 to 5.
METHODS
One hundred twelve patients (mean age 67 ± 13 years), who completed 12 months of exercise training; comprising either balance- or strength training, both in combination with endurance training; with a measured glomerular filtration rate (mGFR) 22.6 ± 8 mL/min/1.73m 2 , were included in this study. AAC was evaluated with lateral lumbar X-ray using the scoring system described by Kauppila. Plasma fetuin-A, fibroblast growth factor 23 (FGF23) and interleukin 6 (IL6) were measured with Enzyme-linked immunosorbent assay (ELISA) kits.
RESULTS
After 12 months of exercise training, the AAC score increased significantly in both groups; mGFR and lipoprotein (a) decreased significantly in both groups; parathyroid hormone (PTH) and 1,25(OH) 2 D 3 increased significantly only in the strength group; fetuin-A increased significantly only in the balance group. Plasma triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, FGF23, phosphate, calcium, IL6, C-reactive protein (CRP), albumin were unchanged. The increase in AAC score was positively related to ageing and the levels of baseline triglycerides and lipoprotein (a).
CONCLUSIONS
Exercise training did not prevent the progression of AAC; it might have contributed to the reduced levels of lipoprotein (a) and unchanged levels of calcific- and inflammatory markers in these patients with non-dialysis dependent CKD. Hypertriglyceridemia, high levels of lipoprotein (a) and ageing emerged as longitudinal predictors of vascular calcification in these patients.
TRIAL REGISTRATION
NCT02041156 at www.ClinicalTrials.gov. Date of registration: January 20, 2014. Retrospectively registered.",2020,"After 12 months of exercise training, the AAC score increased significantly in both groups; mGFR and lipoprotein (a) decreased significantly in both groups; parathyroid hormone (PTH) and 1,25(OH) 2 D 3 increased significantly only in the strength group; fetuin-A increased significantly only in the balance group.","['One hundred twelve patients (mean age 67\u2009±\u200913\u2009years), who completed 12\u2009months of exercise training; comprising either balance- or strength training, both in combination with endurance training; with a measured glomerular filtration rate (mGFR) 22.6\u2009±\u20098\u2009mL/min/1.73m 2 , were included in this study', 'patients with chronic kidney disease (CKD', 'patients with CKD - a sub-study of']","['exercise training', 'balance- or strength- both in combination with endurance training', 'Exercise training', 'RENEXC']","['levels of baseline triglycerides\xa0and lipoprotein (a', 'Plasma triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, FGF23, phosphate, calcium, IL6, C-reactive protein (CRP), albumin', 'Hypertriglyceridemia, high levels of lipoprotein (a', 'parathyroid hormone (PTH) and 1,25(OH) 2 D 3', 'abdominal aortic calcification', 'Plasma fetuin-A, fibroblast growth factor 23 (FGF23) and interleukin 6 (IL6', 'AAC score', 'progression of AAC', 'abdominal aortic calcification (AAC']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C3272931', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1096249', 'cui_str': 'Aortic calcification'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0051477', 'cui_str': 'Alpha>2< hS glycoprotein'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.0882903,"After 12 months of exercise training, the AAC score increased significantly in both groups; mGFR and lipoprotein (a) decreased significantly in both groups; parathyroid hormone (PTH) and 1,25(OH) 2 D 3 increased significantly only in the strength group; fetuin-A increased significantly only in the balance group.","[{'ForeName': 'Yunan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Clinical Sciences Lund, Nephrology, Lund, Sweden, Lund University, Skåne University Hospital, Alwallhuset Barngatan 2A, 121 85, Lund, Sweden.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hellberg', 'Affiliation': 'Department of Clinical Sciences Lund, Nephrology, Lund, Sweden, Lund University, Skåne University Hospital, Alwallhuset Barngatan 2A, 121 85, Lund, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hellmark', 'Affiliation': 'Department of Clinical Sciences Lund, Nephrology, Lund, Sweden, Lund University, Skåne University Hospital, Alwallhuset Barngatan 2A, 121 85, Lund, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Höglund', 'Affiliation': 'Department of Laboratory Medicine, Division of Clinical Chemistry & Pharmacology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Clyne', 'Affiliation': 'Department of Clinical Sciences Lund, Nephrology, Lund, Sweden, Lund University, Skåne University Hospital, Alwallhuset Barngatan 2A, 121 85, Lund, Sweden. Naomi.Clyne@med.lu.se.'}]",BMC nephrology,['10.1186/s12882-020-01881-y']
1086,32579779,Comparison of preincisional and postincisional parasternal intercostal block on postoperative pain in cardiac surgery.,"BACKGROUND
The optimum cardiac surgical pain management has known to maintain hemodynamic stability and, reduces respiratory and cardiovascular complications. Postoperative parasternal intercostal block has shown to reduce postoperative analgesic consumption after cardiac surgery. Therefore, this study sought to investigate the effectiveness of the preoperative ultrasound guided parasternal block in reducing postoperative pain after cardiac surgery.
METHODS
This was a randomized, prospective, interventional, single blind study comprised of 90 adult patients scheduled for cardiac surgery involving sternotomy. Preoperatively and postoperatively, 0.25% bupivacaine administered in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under ultrasound guidance and direct vision, respectively. Postoperative pain was rated according to visual analogue scale. Secondary outcomes included intraoperative and postoperative fentanyl consumptions, dosages of rescue medications, and time to extubation.
MAIN RESULTS
There was no significant differences in visual analogue score visual analogue score at all time points till 24 hours postoperatively. Intraoperative fentanyl requirements (microgram/kg) before cardiopulmonary bypass was significantly lower in pre-incisional group than the post-incisional group (0.16 ± 0.43 vs 0.68 ± 0.72; P = .0001). Furthermore, there were no significant difference in total fentanyl requirement (7.20 ± 2.66 vs 8.37 ± 3.13; P = .06) and tramadol requirement (0.02 ± 0.15 vs 0.07 ± 0.26; P = .28) within first 24 hours. However, time to extubation was significantly higher in the preoperative group (P = .02).
CONCLUSIONS
Preoperative and postoperative parasternal intercostal block provide comparable pain relief during the postoperative period.",2020,Intraoperative fentanyl requirements (microgram/kg) before cardiopulmonary bypass was significantly lower in pre-incisional group than the post-incisional group (0.16 ± 0.43 vs 0.68 ± 0.72;,"['90 adult patients scheduled for cardiac surgery involving sternotomy', 'cardiac surgery']","['preoperative ultrasound guided parasternal block', 'bupivacaine', 'preincisional and postincisional parasternal intercostal block']","['visual analogue score visual analogue score', 'Intraoperative fentanyl requirements', 'total fentanyl requirement', 'pain relief', 'time to extubation', 'postoperative pain', 'postoperative analgesic consumption', 'intraoperative and postoperative fentanyl consumptions, dosages of rescue medications, and time to extubation', 'Postoperative pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442146', 'cui_str': 'Parasternal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",90.0,0.116657,Intraoperative fentanyl requirements (microgram/kg) before cardiopulmonary bypass was significantly lower in pre-incisional group than the post-incisional group (0.16 ± 0.43 vs 0.68 ± 0.72;,"[{'ForeName': 'Sri Rama Ananta Nagabhushanam', 'Initials': 'SRAN', 'LastName': 'Padala', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Ashok Shankar', 'Initials': 'AS', 'LastName': 'Badhe', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Satyen', 'Initials': 'S', 'LastName': 'Parida', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Ajay Kumar', 'Initials': 'AK', 'LastName': 'Jha', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}]",Journal of cardiac surgery,['10.1111/jocs.14651']
1087,32446145,Thyroid hormones ratio is a major prognostic marker in advanced metastatic colorectal cancer: Results from the phase III randomised CORRECT trial.,"BACKGROUND
Free triiodothyronine (FT3)/free thyroxine (FT4) ratio is an index estimating the peripheral activity of thyroid hormones. In a previous experience, we identified a prognostic role for FT3/FT4 ratio in chemorefractory patients treated with regorafenib. Therefore, we planned this post hoc analysis of the phase III CORRECT trial of regorafenib versus placebo.
METHODS
Seven hundred fifty-eight out of 760 randomised patients (503 in the regorafenib and 255 in the placebo arm) were evaluable for the present analyses, based on availability of FT3 and FT4 baseline values. Co-primary objectives were to explore the predictive role of FT3/FT4 ratio in patients treated with regorafenib compared with placebo and to validate the prognostic value of FT3/FT4 ratio in the CORRECT trial.
RESULTS
For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively. Hazard ratio (HR) for OS was 0.40 (p < 0.0001) when comparing intermediate versus low and 0.32 (p < 0.0001) when comparing high versus low FT3/FT4 ratio. In the placebo arm, median OS was 3.3, 5.6 and 7.7 months, in the three subgroups. HR for OS was 0.47 (p < 0.0001) when comparing intermediate versus low and 0.33 (p < 0.0001) when comparing high versus low. FT3/FT4 ratio retained its association with OS in the multivariate model in both arms.
CONCLUSIONS
While rejecting the predictive effect of baseline FT3/FT4 ratio, present data strengthen the prognostic role of the ratio, pave the way for direct clinical application, underline the need for a better biological understanding and suggest possible therapeutic implications for thyroid hormones.",2020,"For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively.","['Seven hundred fifty-eight out of 760 randomised patients (503 in the regorafenib and 255 in the', 'advanced metastatic colorectal cancer']","['regorafenib', 'regorafenib versus placebo', 'Thyroid hormones ratio', 'triiodothyronine (FT3)/free thyroxine ', 'placebo']","['Hazard ratio (HR) for OS', 'median OS', 'median overall survival (OS', 'availability of FT3 and FT4 baseline values', 'FT3/FT4 ratio']","[{'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",760.0,0.121696,"For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pasqualetti', 'Affiliation': 'Department of Clinical & Experimental Medicine, Geriatrics Unit, University of Pisa, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Schirripa', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Dochy', 'Affiliation': 'Bayer Healthcare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Fassan', 'Affiliation': 'Department of Medicine (DIMED), Surgical Pathology & Cytopathology Unit, University of Padua, Padua, Italy.'}, {'ForeName': 'Pina', 'Initials': 'P', 'LastName': 'Ziranu', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Puzzoni', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Scartozzi', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Alberti', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Monzani', 'Affiliation': 'Department of Clinical & Experimental Medicine, Geriatrics Unit, University of Pisa, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy. Electronic address: fotios.loupakis@iov.veneto.it.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.023']
1088,32446304,Effectivity of benzydamine hydrochloride gargle to reduce propofol consumption in endoscopic retrograde cholangiopancreatography procedure: a randomized controlled trial.,"BACKGROUND
Endoscopic Retrograde Cholangiopancreatography (ERCP) is a complex endoscopic procedure that requires moderate to deep sedation. Propofol is the sedative agent of choice for sedation in ERCP due to its fast distribution and fast elimination time without a cumulative effect after infusion, resulting in shorter recovery time. Benzydamine hydrochloride is a topical non-steroidal anti-inflammatory drug that has analgesic, local anesthetic, and anti-inflammatory effects that have been known to be effective in reducing postoperative sore throat. Combination of propofol and topical analgesic may provide adequate sedation and reduce propofol consumption. This study aimed to determine the effectivity of benzydamine hydrochloride gargling in reducing propofol consumption in the ERCP procedure.
METHODS
This study was a single-blind randomized controlled trial for patients undergoing ERCP procedures at Cipto Mangunkusumo Hospital from August to September 2018. A total of 72 subjects were recruited consecutively and randomly assigned into two groups. The first group received 15 mL of 0.15% benzydamine hydrochloride mouthwash prior to the procedure, whereas the second group received 15 mL of water mouthwash. Additional propofol was administered when patient moved or Ramsay Sedation Scale rose above 4. Cumulative propofol consumption per kg body weight per minute and incidence of postoperative sore throat were recorded in each group. Incidence of desaturation, postoperative nausea vomitting, and dysphagia were also recorded. Data analysis was performed with Statistical Package for the Social Sciences.
RESULTS
Cumulative propofol consumption per minute per kg body weight in the benzydamine hydrochloride group was 152.7 (91.9-238.8) mcg/kg/minute, while in the control group was 200.05 (114.4-380.2) mcg/kg/ minute (p = < 0.001). The incidence of sore throat on the 0th, 2nd, and 4th hour for the benzydamine hydrochloride group was 11.4, 11.4, and 5.7%, while in the control group was 50, 52.8, and 36.1% (p = < 0.001, < 0.001, 0.003). Desaturation was found in control group whereas none in benzydamine hydrochloride group. Complaints of nausea and vomiting were comparable in both groups.
CONCLUSION
Benzydamine hydrochloride gargling was effective in reducing cumulative propofol consumption in the ERCP procedure.
TRIAL REGISTRATION
Study was registered retrospectively in ClinicalTrials.gov with NCT04167592 on November 8th 2019.",2020,"Complaints of nausea and vomiting were comparable in both groups.
","['endoscopic retrograde cholangiopancreatography procedure', 'A total of 72 subjects', 'patients undergoing ERCP procedures at Cipto Mangunkusumo Hospital from August to September 2018']","['Benzydamine hydrochloride', '15\u2009mL of 0.15% benzydamine hydrochloride', 'propofol', 'propofol and topical analgesic', 'Endoscopic Retrograde Cholangiopancreatography (ERCP', 'benzydamine hydrochloride', 'Propofol', '15\u2009mL of water mouthwash', 'benzydamine hydrochloride gargle']","['Incidence of desaturation, postoperative nausea vomitting, and dysphagia', 'Cumulative propofol consumption per minute per kg body weight', 'cumulative propofol consumption', 'Desaturation', 'Complaints of nausea and vomiting', 'Cumulative propofol consumption per kg body weight per minute and incidence of postoperative sore throat', 'propofol consumption', 'incidence of sore throat']","[{'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0282070', 'cui_str': 'Benzydamine hydrochloride'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}]",72.0,0.100761,"Complaints of nausea and vomiting were comparable in both groups.
","[{'ForeName': 'Adhrie', 'Initials': 'A', 'LastName': 'Sugiarto', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo General Hospital, Pangeran Diponegoro Street No. 71, Jakarta, Indonesia. adhrie@gmail.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Kapuangan', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo General Hospital, Pangeran Diponegoro Street No. 71, Jakarta, Indonesia.'}, {'ForeName': 'Aida Rosita', 'Initials': 'AR', 'LastName': 'Tantri', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo General Hospital, Pangeran Diponegoro Street No. 71, Jakarta, Indonesia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chrisnata', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo General Hospital, Pangeran Diponegoro Street No. 71, Jakarta, Indonesia.'}]",BMC anesthesiology,['10.1186/s12871-020-00996-x']
1089,32447545,Improvement in Function after Lasmiditan Treatment: Post Hoc Analysis of Data from Phase 3 Studies.,"INTRODUCTION
Migraine is associated with substantial functional impairment and affects many aspects of daily life.
METHODS
Using data from SAMURAI and SPARTAN (double-blind, placebo-controlled, phase 3 studies) and GLADIATOR (an open-label, phase 3 study enrolling patients who had completed SAMURAI or SPARTAN), we assessed the effects of lasmiditan on migraine-related functional disability at multiple time points from 0.5 to 48 h post dose by asking patients to rate how much the migraine was interfering with normal activities. Pooled data from SAMURAI and SPARTAN (SAMURAI + SPARTAN) and data from GLADIATOR were analyzed using the intention-to-treat populations.
RESULTS
For SPARTAN + SAMURAI, significantly more patients who received lasmiditan at any dose versus placebo reported freedom from migraine-related functional disability at every timepoint from 2 h post dose, and this difference persisted to 48 h (p < 0.05). Significant differences from placebo in freedom from migraine-related functional disability commenced at 1 h post dose for lasmiditan 200 mg, 1.5 h for lasmiditan 100 mg, and 2 h for lasmiditan 50 mg. Findings from GLADIATOR supported those from SAMURAI + SPARTAN.
CONCLUSION
All doses of lasmiditan resulted in an improvement in migraine-related functional disability that persisted to 48 h. In SAMURAI + SPARTAN, a significant difference from placebo was observed as early as 1 h post dose. TRIAL REGISTRATION AT CLINICALTRIALS.GOV: SAMURAI (NCT02439320), SPARTAN (NCT02605174), and GLADIATOR (NCT02565186).",2020,"Significant differences from placebo in freedom from migraine-related functional disability commenced at 1 h post dose for lasmiditan 200 mg, 1.5 h for lasmiditan 100 mg, and 2 h for lasmiditan 50 mg.",[],['placebo'],['migraine-related functional disability'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.259392,"Significant differences from placebo in freedom from migraine-related functional disability commenced at 1 h post dose for lasmiditan 200 mg, 1.5 h for lasmiditan 100 mg, and 2 h for lasmiditan 50 mg.","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': 'StudyMetrix Research, St. Peters, MO, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krege', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Suchitrita S', 'Initials': 'SS', 'LastName': 'Rathmann', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sherie A', 'Initials': 'SA', 'LastName': 'Dowsett', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hake', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Emel S M', 'Initials': 'ESM', 'LastName': 'Nery', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Brandy R', 'Initials': 'BR', 'LastName': 'Matthews', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Erin G', 'Initials': 'EG', 'LastName': 'Doty', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA. doty_erin_gautier@lilly.com.'}]",Neurology and therapy,['10.1007/s40120-020-00185-5']
1090,32453396,"Effects of coadministration of DHA and vitamin E on spermatogram, seminal oxidative stress, and sperm phospholipids in asthenozoospermic men: a randomized controlled trial.","BACKGROUND
It is unknown which compounds in spermatozoa or seminal plasma may be involved in the regulation of sperm motility.
OBJECTIVES
The aim of this study was to investigate the effects of DHA (22:6n-3), vitamin E, and their probable interactions in men with asthenozoospermia.
METHODS
A factorial, randomized, double-blind, placebo-controlled trial was conducted in infertility clinics in Tehran, Iran. The participants were idiopathic asthenozoospermic men aged 20-45 y, with normal endocrine function. Their concentration of spermatozoa and percentage of morphologically normal spermatozoa were equal to or above the lower reference limits, according to the fifth edition of the WHO guideline. Out of 717 men referred to the infertility clinics, 180 asthenozoospermic men were randomly assigned to 1 of 4 groups according to stratified blocked randomization by age and sperm concentration. Participants took daily 465 mg DHA plus 600 IU vitamin E (DE), 465 mg DHA plus placebo (DP), 600 IU vitamin E plus placebo (EP), or both placebo capsules (PP) for 12 wk. Sperm characteristics, oxidative stress of seminal plasma, serum and sperm membrane fatty acids, dietary intakes, anthropometric measurements, and physical activity were measured at baseline and after 12 wk.
RESULTS
After the intervention, mean ± SD sperm progressive motility was greater in the DE group (27.9 ± 2.8) than in the DP (25.7 ± 3.4), EP (26.1 ± 2.8), and PP (25.8 ± 2.6) groups (P < 0.05). Sperm count (P = 0.001) and concentration (P = 0.044) increased significantly in the DE group compared with the other 3 groups, whereas other semen parameters were not significantly different between the groups after the intervention. Serum concentrations of n-3 PUFAs were significantly higher in the DE and DP groups than in the EP and PP groups.
CONCLUSIONS
Combined DHA and vitamin E supplements led to increased sperm motility; however, no significant changes occurred in sperm morphology and vitality in asthenozoospermic men.This trial was registered at clinicaltrials.gov as NCT01846325.",2020,"Serum concentrations of n-3 PUFAs were significantly higher in the DE and DP groups than in the EP and PP groups.
","['participants were idiopathic asthenozoospermic men aged 20-45 y, with normal endocrine function', '717 men referred to the infertility clinics, 180 asthenozoospermic men', 'infertility clinics in Tehran, Iran', 'men with asthenozoospermia', 'asthenozoospermic men']","['DHA and vitamin E', 'DHA (22:6n-3), vitamin E', 'DHA and vitamin E supplements', 'DHA plus 600 IU vitamin E (DE), 465 mg DHA plus placebo (DP), 600 IU vitamin E plus placebo (EP), or both placebo capsules (PP', 'placebo']","['Sperm characteristics, oxidative stress of seminal plasma, serum and sperm membrane fatty acids, dietary intakes, anthropometric measurements, and physical activity', 'sperm motility', 'Sperm count', 'Serum concentrations of n-3 PUFAs', 'spermatogram, seminal oxidative stress, and sperm phospholipids', 'mean\xa0±\xa0SD sperm progressive motility', 'sperm morphology and vitality']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0678896', 'cui_str': 'Endocrine function'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3715200', 'cui_str': 'Infertility clinic'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0403823', 'cui_str': 'Asthenospermia'}]","[{'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C3661607', 'cui_str': 'Vitamin E supplement'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0242499', 'cui_str': 'Seminal plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037848', 'cui_str': 'Motility of spermatozoa'}, {'cui': 'C0037842', 'cui_str': 'Sperm count'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0428011', 'cui_str': 'Sperm morphology'}]",717.0,0.607753,"Serum concentrations of n-3 PUFAs were significantly higher in the DE and DP groups than in the EP and PP groups.
","[{'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Eslamian', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Amirjannati', 'Affiliation': 'Department of Andrology and Embryology, Reproductive Biotechnology Research Center, Avicenna Research Institute, ACECR, Tehran, Iran.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Noori', 'Affiliation': ""Division of Nephrology, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Andrology and Embryology, Reproductive Biotechnology Research Center, Avicenna Research Institute, ACECR, Tehran, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa124']
1091,32457513,A mobile-based educational intervention on sexo-marital life in Iranian men with spinal cord injury: a randomized controlled trial.,"STUDY DESIGN
A randomized controlled trial.
OBJECTIVE
To assess the effectiveness of a mobile-based educational intervention on sexo-marital life in Iranian men with spinal cord injury (SCI).
SETTING
Foundation of Martyrs and Veterans Affairs', ""Spinal Cord Injury Association"", and the ""Protection Center of Spinal Cord Disables"".
METHODS
Participants were men with SCI aged at least 18 years old. The effectiveness of a mobile App was evaluated on 70 married men with SCI. Sexual adjustment, sexual satisfaction, marital adjustment, and marital satisfaction were assessed by valid and reliable questionnaires at baseline, 4 and 8 weeks after the intervention.
RESULTS
The between-group mean difference (95% CI) of sexual adjustment (4.2, CI: 3.6-4.8) after 4 weeks as well as 8 weeks (8.6, CI: 7.6-9.5) after baseline was significant (P < 0.001). The between-group mean difference (95% CI) of sexual satisfaction (6.9, CI: 8-11.2) after 4 weeks as well as 8 weeks (16.4, CI: 14.1-18.7) after baseline was significant (P < 0.001). There were significant increases in all the domains of marital satisfaction's between-group mean differences after 4 weeks as well as 8 weeks after baseline (P < 0.001). Repeated measures ANOVA showed there was no statistically significant increase in marital adjustment's between-group mean difference (95% CI) after 4 weeks (-0.1, CI: -0.1- 0, P < 0.16) as well as 8 weeks (0.4, CI: -0.3-1.1, P < 0.25) after baseline.
CONCLUSION
The application-based educational intervention showed the positive effect of education on sexo-marital life in men with SCI. We recommend the rehabilitation team's healthcare providers embrace this educational strategy for individuals with SCI.",2020,There were significant increases in all the domains of marital satisfaction's between-group mean differences after 4 weeks as well as 8 weeks after baseline (P < 0.001).,"['Iranian men with spinal cord injury', 'Iranian men with spinal cord injury (SCI', 'Participants were men with SCI aged at least 18 years old', 'individuals with SCI', '70 married men with SCI', 'men with SCI']","['mobile App', 'mobile-based educational intervention']","['sexo-marital life', ""marital satisfaction's"", ""marital adjustment's"", 'Sexual adjustment, sexual satisfaction, marital adjustment, and marital satisfaction', 'sexual satisfaction']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}]",70.0,0.352686,There were significant increases in all the domains of marital satisfaction's between-group mean differences after 4 weeks as well as 8 weeks after baseline (P < 0.001).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Zarei', 'Affiliation': 'Department of Health Education & Health Promotion, Faculty of Medical Sciences, Tarbiat Modares University (TMU), Tehran, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Rashedi', 'Affiliation': 'Department of Reproductive Health, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Tavousi', 'Affiliation': 'Health Metrics Research Center, Iranian Institute for Health Sciences Research, ACECR, Tehran, Iran.'}, {'ForeName': 'Ali Asghar', 'Initials': 'AA', 'LastName': 'Haeri-Mehrizi', 'Affiliation': 'Health Metrics Research Center, Iranian Institute for Health Sciences Research, ACECR, Tehran, Iran.'}, {'ForeName': 'Raziyeh', 'Initials': 'R', 'LastName': 'Maasoumi', 'Affiliation': 'Department of Reproductive Health, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran. r_masoumi@sina.tums.ac.ir.'}]",Spinal cord,['10.1038/s41393-020-0489-4']
1092,32462856,"Effects of essential amino acid supplementation on pain in the elderly with hip fractures: a pilot, double-blind, placebo-controlled, randomised clinical trial.",,2020,,['elderly with hip fractures'],"['essential amino acid supplementation', 'placebo']",['pain'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}]","[{'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.620566,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rondanelli', 'Affiliation': 'IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Guido', 'Affiliation': 'Epidemiology Unit, Agency for Health Protection of Milan, Milan, Italy.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Faliva', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gasparri', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Peroni', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Iannello', 'Affiliation': ""General Management, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', Pavia, Italy.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nichetti', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Naso', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Infantino', 'Affiliation': 'University of Bari, Department of Biomedical Science and Human Oncology, Bari, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Spadaccini', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Perna', 'Affiliation': 'University of Bahrain, Department of Biology, College of Science, Sakhir Campus, Kingdom of Bahrain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Aquilani', 'Affiliation': 'Department of Biology and Biotechnology University of Pavia.'}]",Journal of biological regulators and homeostatic agents,['10.23812/19-452-L-46']
1093,32466187,Effect of Different Running Exercise Modalities on Post-Exercise Oxidative Stress Markers in Trained Athletes.,"The aim of this study was to examine the effect of running exercise modality on oxidative stress. Thirteen endurance athletes (age: 21.46 ± 0.66 years) performed three different running exercise modalities (Continuous running exercise (CR): continuous running exercise at 75% of VO 2max for 25 min; intermittent running exercise #1 (15/15): intermittent running protocol, 15 s running at 75% of VO 2max , 15 s passive recovery, performed for 50 min; intermittent running exercise #2 (30/30): intermittent running protocol, 30 s running at 75% of VO 2max , 30 s passive recovery, performed for 50 min) in a randomized order. Blood samples were drawn at rest and immediately after each running exercise and assessed for malondialdehyde (MDA), advanced oxidation protein products (AOPP), superoxide dismutase(SOD), and glutathione peroxidase (GPX) activities. MDA increased by 55% following 30/30 exercise ( p < 0.01), while it remained unchanged with CR and15/15 exercise. SOD increased after CR (+13.9%, p < 0.05), and also remained unchanged after 15/15 ( p > 0.05) and decreased after 30/30 (-19.7% p < 0.05). GPX and AOPP did not change after exercise in all experimental sessions ( p > 0.05). In conclusion, 30/30 intermittent running induced higher lipid damages than the 15/15 and CR exercise. 15/15 intermittent exercise promoted a better balance between free radicals production and antioxidant defense compared to continuous exercise and intermittent 30/30 exercise.",2020,"MDA increased by 55% following 30/30 exercise ( p < 0.01), while it remained unchanged with CR and15/15 exercise.","['Thirteen endurance athletes (age: 21.46 ± 0.66 years', 'Trained Athletes']","['running exercise modalities (Continuous running exercise (CR): continuous running exercise at 75% of VO 2max for 25 min; intermittent running exercise #1 (15/15): intermittent running protocol, 15 s running at 75% of VO 2max , 15 s passive recovery, performed for 50 min; intermittent running exercise #2 (30/30): intermittent running protocol, 30 s running at 75% of VO 2max', 'Different Running Exercise Modalities', 'running exercise modality']","['SOD', 'oxidative stress', 'malondialdehyde (MDA), advanced oxidation protein products (AOPP), superoxide dismutase(SOD), and glutathione peroxidase (GPX) activities', 'GPX and AOPP', 'MDA', 'lipid damages', 'Post-Exercise Oxidative Stress Markers']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C1976991', 'cui_str': 'Advanced oxidation protein products'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",13.0,0.0473095,"MDA increased by 55% following 30/30 exercise ( p < 0.01), while it remained unchanged with CR and15/15 exercise.","[{'ForeName': 'Wajdi', 'Initials': 'W', 'LastName': 'Souissi', 'Affiliation': 'Research Laboratory: Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Bouzid', 'Affiliation': 'Research Laboratory: Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Farjallah', 'Affiliation': 'Research Laboratory: Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Lobna', 'Initials': 'L', 'LastName': 'Ben Mahmoud', 'Affiliation': 'Pharmacology Department, Faculty of Medicine, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Mariem', 'Initials': 'M', 'LastName': 'Boudaya', 'Affiliation': 'Biochemistry Laboratory, CHU HediChaker, University of Sfax, Sfax 3000, Tunisia.'}, {'ForeName': 'Florian A', 'Initials': 'FA', 'LastName': 'Engel', 'Affiliation': 'Institute of Sport and Sport Science, Heidelberg University, 69120 Heidelberg, Germany.'}, {'ForeName': 'Zouheir', 'Initials': 'Z', 'LastName': 'Sahnoun', 'Affiliation': 'Pharmacology Department, Faculty of Medicine, University of Sfax, Sfax 3000, Tunisia.'}]",International journal of environmental research and public health,['10.3390/ijerph17103729']
1094,32472141,"A Prospective Cohort Study to Evaluate the Impact of Diet, Exercise, and Lifestyle on Fertility: Design and Baseline Characteristics.","Diet, lifestyle, and psychosocial factors might influence fertility for men and women, although evidence is mixed, and couple-based approaches are needed for assessing associations with reproductive outcomes. The Impact of Diet, Exercise, and Lifestyle (IDEAL) on Fertility Study is a prospective cohort with contemporaneous detailed follow-up of female partners of men enrolled in the Folic Acid and Zinc Supplementation Trial studying couples seeking infertility treatment (2016-2019). Follow-up of men continued for 6 months, while female partners were followed for 9 months while attempting pregnancy and throughout any resulting pregnancy (up to 18 months). Longitudinal data on diet, physical activity (including measurement via wearable device), sleep, and stress were captured at multiple study visits during this follow-up. A subset of women (IDEALplus) also completed daily journals and a body fat assessment via dual-energy x-ray absorptiometry. IDEAL enrolled 920 women, and IDEALPlus enrolled 218. We demonstrated the ability to enroll women in a prospective cohort study contemporaneous to a partner-enrolled randomized trial. In combination with data collected on male partners, IDEAL data facilitates a couple-based approach to understanding associations between lifestyle factors and infertility treatment outcomes. We describe in detail the study design, recruitment, data collection, lessons learned, and baseline characteristics.",2020,"In combination with data collected on male partners, IDEAL data facilitates a couple-based approach to understanding associations between lifestyle factors and infertility treatment outcomes.","['female partners of men enrolled in the', 'male partners', 'men and women', '920 women were enrolled in IDEAL and 218 in IDEALPlus', 'Trial studying couples seeking infertility treatment (2016-2019']","['Diet, Exercise, and Lifestyle on Fertility', 'Diet, Exercise, and Lifestyle', 'Folic Acid and Zinc Supplementation']","['diet, physical activity (including measurement via Fitbit), sleep, and stress']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0200070', 'cui_str': 'Infertility therapy'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",920.0,0.0272319,"In combination with data collected on male partners, IDEAL data facilitates a couple-based approach to understanding associations between lifestyle factors and infertility treatment outcomes.","[{'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': ''}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Johnstone', 'Affiliation': ''}, {'ForeName': 'Keewan', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Mudsar', 'Initials': 'M', 'LastName': 'Ahmad', 'Affiliation': ''}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Salmon', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': ''}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Chaney', 'Affiliation': ''}, {'ForeName': 'Ginny', 'Initials': 'G', 'LastName': 'Ryan', 'Affiliation': ''}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Hotaling', 'Affiliation': ''}, {'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'Purdue-Smithe', 'Affiliation': ''}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Clemons', 'Affiliation': ''}]",American journal of epidemiology,['10.1093/aje/kwaa073']
1095,32473084,"A randomized, single-blinded, vehicle-controlled study of a topical active blend in the treatment of androgenetic alopecia.","Αndrogenetic alopecia (AGA) is the most common hair disorder, affecting approximately 50% of men and women. A topical lotion that contains two patented formulas (Redensyl and Sepicontrol A5), has been introduced as an alternative approach to standard therapies for AGA. Forty-four patients with AGA were randomized either to apply the active lotion or the vehicle, twice daily for 24 weeks. Subjects were evaluated at 0, 12, and 24 weeks by clinical examination, photographic documentation, quality of life evaluation (DLQI), and trichogram (anagen-to-telogen ratio). Forty-one patients, 18 males and 23 females, completed the study. Among patients receiving active treatment (n = 26), 7.7% had great improvement, 73.1% had moderate improvement, and 19.2% remained stable. The median self-assessment score increased from 4 at baseline to 6 at 24 weeks (P < .001), while the DLQI improved from 4 to 3, respectively (P < .001). The median anagen-to-telogen ratio increased from 2.25 to 4.00 to 6.02 at weeks 0, 12, and 24, respectively. No significant adverse events were reported. This new topical active blend is effective in the treatment of AGA, with high degree of patients' satisfaction, improvement of quality of life, and an excellent safety profile. Thus, it may represent a useful alternative therapeutic approach for AGA.",2020,"The median self-assessment score increased from 4 at baseline to 6 at 24 weeks (p<0.001), while the DLQI improved from 4 to 3, respectively (p<0.001).","['Forty-four patients with AGA', 'Forty-one patients, 18 males and 23 females', 'androgenetic alopecia']",['active lotion'],"['median self-assessment score', 'DLQI', 'clinical examination, photographic documentation, quality of life evaluation (DLQI), and trichogram (anagen to telogen ratio', 'adverse events', 'median anagen to telogen ratio']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0071561', 'cui_str': 'polyethylene glycol-glutaminase-asparaginase'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0519989', 'cui_str': 'Hair pluck test'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",44.0,0.0689808,"The median self-assessment score increased from 4 at baseline to 6 at 24 weeks (p<0.001), while the DLQI improved from 4 to 3, respectively (p<0.001).","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Katoulis', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Aikaterini I', 'Initials': 'AI', 'LastName': 'Liakou', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Koumaki', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Efstratios', 'Initials': 'E', 'LastName': 'Vakirlis', 'Affiliation': 'Department of Dermatology and Venereology, Aristotle University of Thessaloniki, Skin and Venereal Diseases Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Andreas G', 'Initials': 'AG', 'LastName': 'Tsantes', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Despina', 'Initials': 'D', 'LastName': 'Mortaki', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Bozi', 'Affiliation': 'Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, ""Attikon"" General University Hospital, Athens, Greece.'}, {'ForeName': 'Demetrios', 'Initials': 'D', 'LastName': 'Ioannides', 'Affiliation': 'Department of Dermatology and Venereology, Aristotle University of Thessaloniki, Skin and Venereal Diseases Hospital, Thessaloniki, Greece.'}]",Dermatologic therapy,['10.1111/dth.13734']
1096,32473649,"The propofol-sparing effect of intravenous lidocaine in elderly patients undergoing colonoscopy: a randomized, double-blinded, controlled study.","BACKGROUND
Propofol provides a prominent sedation effect in colonoscopy. However, anesthesia and sedation induced with propofol in the elderly might result in cardiopulmonary complications, especially when it is combined with opoids in the regimen. This study aimed to test the hypothesis that the addition of intravenous lidocaine to propofol-based sedation could decrease the overall propofol requirement in elderly patients during colonoscopy while the procedural sedation satisfaction and the hemodynamic stability were not compromised.
METHODS
Ninety-two patients undergoing colonoscopy were randomly enrolled into lidocaine+propofol (L + P) group or normal saline+propofol (NS + P) groups. Subjects received intravenous bolus of 1.5 mg/kg lidocaine followed by 4 mg kg - 1 h - 1 lidocaine continuous infusion in L + P group or equivalent volumes of normal saline for boluses and infusion in NS + P group. Anesthesia was induced with 2.5 μg sufentanil followed by injection of 1.2 mg kg - 1 propofol in all patients. A single supplemental bolus of 0.6 mg kg - 1 propofol was administered whenever MOAA/S score > 1 or had body movement during the colonoscopy. The recorded primary endpoints included: the total amount of propofol administered during entire procedure, the supplemental amount of propofol after induction, and the frequencies of boluses of supplemental propofol.
RESULTS
A total of 79 patients were included in the final analysis. Compared with NS + P group, the total amounts of propofol (induction plus supplemental) were no significant differences in L + P group; however, the required supplemental propofol was less (69.9 ± 39.2 mg vs. 51.5 ± 38.6 mg) (P = 0.039); the average frequencies of boluses of supplemental propofol given after induction were lower (2.1 ± 1.1 vs. 1.4 ± 0.9) (P = 0.003); the calculated ""unit propofol"" infusion rate was lower (0.18 ± 0.05 vs. 0.14 ± 0.04 mg kg - 1 min - 1 ) (P = 0.002).
CONCLUSIONS
The addition of intravenous lidocaine to propofol-based sedation resulted in a remarked reduction of supplemental propofol in the elderly during colonoscopy.
TRIAL REGISTRATION
The present clinical trial was registered at http://www.chictr.org.cn on 11th March 2019 (registration No. ChiCTR1900021818).",2020,"Compared with NS + P group, the total amounts of propofol (induction plus supplemental) were no significant differences in L + P group; however, the required supplemental propofol was less (69.9 ± 39.2 mg vs. 51.5 ± 38.6 mg) (P = 0.039); the average frequencies of boluses of supplemental propofol given after induction were lower (2.1 ± 1.1 vs. 1.4 ± 0.9) (P = 0.003); the calculated ""unit propofol"" infusion rate was lower (0.18 ± 0.05 vs. 0.14 ± 0.04 mg kg - 1 min - 1 ) (P = 0.002).
","['elderly patients during colonoscopy', 'A total of 79 patients were included in the final analysis', 'Ninety-two patients undergoing colonoscopy', 'elderly patients undergoing colonoscopy']","['lidocaine+propofol (L\u2009+\u2009P) group or normal saline+propofol (NS\u2009+\u2009P', 'lidocaine', 'intravenous lidocaine', 'propofol-based sedation', 'intravenous bolus of 1.5\u2009mg/kg lidocaine', 'lidocaine continuous infusion in L\u2009+\u2009P group or equivalent volumes of normal saline for boluses and infusion in NS\u2009+\u2009P group', 'Propofol', 'propofol']","['calculated ""unit propofol"" infusion rate', 'overall propofol requirement', 'total amount of propofol administered during entire procedure, the supplemental amount of propofol after induction, and the frequencies of boluses of supplemental propofol', 'total amounts of propofol']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",79.0,0.134813,"Compared with NS + P group, the total amounts of propofol (induction plus supplemental) were no significant differences in L + P group; however, the required supplemental propofol was less (69.9 ± 39.2 mg vs. 51.5 ± 38.6 mg) (P = 0.039); the average frequencies of boluses of supplemental propofol given after induction were lower (2.1 ± 1.1 vs. 1.4 ± 0.9) (P = 0.003); the calculated ""unit propofol"" infusion rate was lower (0.18 ± 0.05 vs. 0.14 ± 0.04 mg kg - 1 min - 1 ) (P = 0.002).
","[{'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China.""}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China.""}, {'ForeName': 'Qingxia', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China.""}, {'ForeName': 'Junzheng', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesia and Pediatrics, Cincinnati Children Hospital Medical Center, Cincinnati, OH, USA.'}, {'ForeName': 'Wangning', 'Initials': 'W', 'LastName': 'Shangguan', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China. sgwning@163.com.""}]",BMC anesthesiology,['10.1186/s12871-020-01049-z']
1097,32488378,Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: baseline results in a cluster preference randomised controlled trial.,"PURPOSE
The main aim of this paper is to present baseline demographic and clinical characteristics and HRQOL in the two groups of the Patient Concerns Inventory (PCI) trial. The baseline PCI data will also be described.
METHODS
This is a pragmatic cluster preference randomised control trial with 15 consultant clusters from two sites either 'using' (n = 8) or 'not using' (n = 7) the PCI at a clinic for all of their trial patients. The PCI is a 56-item prompt list that helps patients raise concerns that otherwise might be missed. Eligibility was head and neck cancer patients treated with curative intent (all sites, stage of disease, treatments).
RESULTS
From 511 patients first identified as eligible when screening for the multi-disciplinary tumour board meetings, 288 attended a first routine outpatient baseline study clinic after completion of their treatment, median (IQR) of 103 (71-162) days. At baseline, the two trial groups were similar in demographic and clinical characteristics as well as in HRQOL measures apart from differences in tumour location, tumour staging and mode of treatment. These exceptions were cluster (consultant) related to Maxillofacial and ENT consultants seeing different types of cases. Consultation times were similar, with PCI group times taking about 1 min longer on average (95% CL for the difference between means was from - 0.7 to + 2.2 min).
CONCLUSION
Using the PCI in routine post-treatment head and neck cancer clinics do not elongate consultations. Recruitment has finished but 12-month follow-up is still ongoing.",2020,"At baseline, the two trial groups were similar in demographic and clinical characteristics as well as in HRQOL measures apart from differences in tumour location, tumour staging and mode of treatment.","['Eligibility was head and neck cancer patients treated with curative intent (all sites, stage of disease, treatments', 'head and neck cancer patients', ""15 consultant clusters from two sites either 'using' (n\u2009=\u20098) or 'not using' (n\u2009=\u20097) the PCI at a clinic for all of their trial patients"", '511 patients first identified as eligible when screening for the multi-disciplinary tumour board meetings, 288 attended a first routine outpatient baseline study clinic after completion of their treatment, median (IQR) of 103 (71-162) days']",[],"['Consultation times', 'Improving quality of life']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],"[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",511.0,0.201374,"At baseline, the two trial groups were similar in demographic and clinical characteristics as well as in HRQOL measures apart from differences in tumour location, tumour staging and mode of treatment.","[{'ForeName': 'Simon N', 'Initials': 'SN', 'LastName': 'Rogers', 'Affiliation': 'Faculty of Health and Social Care, Edge Hill University, Ormskirk, L39 4QP, UK. simonn.rogers@aintree.nhs.uk.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Allmark', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'Fazilet', 'Initials': 'F', 'LastName': 'Bekiroglu', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Rhiannon Tudor', 'Initials': 'RT', 'LastName': 'Edwards', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation (CHEME), School of Healthcare Sciences, College of Health and Behavioural Sciences (CoHaBS), Ardudwy Building, Normal Site, Bangor University, Bangor, UK.'}, {'ForeName': 'Gillon', 'Initials': 'G', 'LastName': 'Fabbroni', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Flavel', 'Affiliation': ', Guildford, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Highet', 'Affiliation': 'Liverpool Head and Neck Clinical Trials, Clinical Sciences Building, University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Michael W S', 'Initials': 'MWS', 'LastName': 'Ho', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'Gerald M', 'Initials': 'GM', 'LastName': 'Humphris', 'Affiliation': 'School of Medicine, Medical and Biological Sciences, North Haugh, St Andrews, UK.'}, {'ForeName': 'Terry M', 'Initials': 'TM', 'LastName': 'Jones', 'Affiliation': 'Liverpool Head and Neck Centre, University of Liverpool, Cancer Research Centre, 200 London Road, Liverpool, L3 9GA, UK.'}, {'ForeName': 'Owais', 'Initials': 'O', 'LastName': 'Khattak', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Lancaster', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Loh', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Lowe', 'Affiliation': 'Astraglobe Ltd, Congleton, Cheshire, UK.'}, {'ForeName': 'Cher', 'Initials': 'C', 'LastName': 'Lowies', 'Affiliation': 'Liverpool Head and Neck Clinical Trials, Clinical Sciences Building, University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Macareavy', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moor', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Ong', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Prasai', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Roland', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Cherith', 'Initials': 'C', 'LastName': 'Semple', 'Affiliation': 'Institute of Nursing and Health Research, Ulster University, Shore Road, Newtownabbey, Co. Antrim, BT37 0QB, UK.'}, {'ForeName': 'Llinos Haf', 'Initials': 'LH', 'LastName': 'Spencer', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation (CHEME), School of Healthcare Sciences, College of Health and Behavioural Sciences (CoHaBS), Ardudwy Building, Normal Site, Bangor University, Bangor, UK.'}, {'ForeName': 'Sank', 'Initials': 'S', 'LastName': 'Tandon', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Oral and Maxillofacial Surgery Department, Bristol University, Lower Maudlin Street, Bristol, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Schache', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Shaw', 'Affiliation': 'Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Kanatas', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06077-6']
1098,32683644,"Efficacy and Safety of Intravenously Administered Tramadol in Patients with Moderate to Severe Pain Following Bunionectomy: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study.","INTRODUCTION
This study is part of the registrational program for intravenously administered (IV) tramadol in the USA and compared the analgesic benefit and tolerability of two doses of IV tramadol (50 mg and 25 mg) to placebo in adult patients undergoing bunionectomy, an orthopedic surgical model.
METHODS
This was a phase 3, multicenter, double-blind, three-arm, randomized, placebo-controlled, multiple-dose, parallel-group trial to evaluate IV tramadol in the management of postoperative pain following bunionectomy. Eligible patients were randomized (1:1:1 ratio) to IV tramadol 50 mg, 25 mg, or placebo. Primary endpoint was summary of pain intensity differences over 48 h (SPID48). Key secondary endpoints included SPID24, total consumption of rescue analgesia, and patient global assessment of efficacy (PGA). Safety assessments included treatment emergent adverse events (TEAEs), clinical laboratory tests, vital signs, and electrocardiograms (ECGs). Assessment of the dose-response was an important objective of the study.
RESULTS
The study established a dose response, with IV tramadol 50 mg demonstrating statistically significant benefit (p < 0.05) over placebo for primary and all key secondary efficacy endpoints, whereas tramadol 25 mg demonstrated intermediate results between the 50 mg and placebo arms. IV tramadol 50 mg was well tolerated; most common TEAEs were nausea and vomiting; and there were no meaningful differences among treatments for vital signs, ECG, and laboratory assessments. The largest proportion of patients completed tramadol 50 mg (98.6%) compared to tramadol 25 mg (91.8%) and placebo (88.2%).
CONCLUSION
IV tramadol 50 mg was effective and well tolerated as treatment for postoperative pain following bunionectomy surgery, while IV tramadol 25 mg, although well tolerated, was judged an ineffective dose for the treatment of pain in this setting. IV tramadol 50 mg was further developed in the registrational program for the USA.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT03290378.",2020,"mg was well tolerated; most common TEAEs were nausea and vomiting; and there were no meaningful differences among treatments for vital signs, ECG, and laboratory assessments.","['adult patients undergoing bunionectomy, an orthopedic surgical model', 'Eligible patients', 'Patients with Moderate to Severe Pain', 'postoperative pain following bunionectomy']","['Bunionectomy', 'Placebo', 'IV tramadol', 'Tramadol', 'tramadol', 'tramadol 50\xa0mg, 25\xa0mg, or placebo', 'placebo']","['Efficacy and Safety', 'nausea and vomiting', 'treatment emergent adverse events (TEAEs), clinical laboratory tests, vital signs, and electrocardiograms (ECGs', 'SPID24, total consumption of rescue analgesia, and patient global assessment of efficacy (PGA', 'effective and well tolerated', 'pain intensity differences over 48\xa0h (SPID48']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1542057', 'cui_str': 'Silver bunionectomy'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0887962', 'cui_str': 'Models, Surgical'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]","[{'cui': 'C1542057', 'cui_str': 'Silver bunionectomy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.495008,"mg was well tolerated; most common TEAEs were nausea and vomiting; and there were no meaningful differences among treatments for vital signs, ECG, and laboratory assessments.","[{'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Singla', 'Affiliation': 'Lotus Clinical Research, Pasadena, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pollak', 'Affiliation': 'Evolution Research Group, New Providence, NJ, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gottlieb', 'Affiliation': 'Chesapeake Research Group, Pasadena, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leiman', 'Affiliation': 'HD Research, Bellaire, TX, USA.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Minkowitz', 'Affiliation': 'HD Research, Bellaire, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zimmerman', 'Affiliation': 'Trovare Clinical Research, Bakersfield, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harnett', 'Affiliation': 'Avenue Therapeutics, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'Avenue Therapeutics, New York, NY, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Avenue Therapeutics, New York, NY, USA. llu@avenuetx.com.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Reines', 'Affiliation': 'Avenue Therapeutics, New York, NY, USA.'}]",Pain and therapy,['10.1007/s40122-020-00184-2']
1099,32568651,Theophylline as an Add-On to Thrombolytic Therapy in Acute Ischemic Stroke: A Randomized Placebo-Controlled Trial.,"BACKGROUND AND PURPOSE
Delayed recanalization increases the risk of infarct growth and poor clinical outcome in acute ischemic stroke. The vasoactive agent theophylline has shown neuroprotective effects in animal stroke models but inconclusive results in case series and randomized clinical trials. The primary objective of this study was to evaluate whether theophylline, as an add-on to thrombolytic therapy, is safe and effective in acute ischemic stroke patients.
METHODS
The TEA-Stroke trial (The Theophylline in Acute Ischemic Stroke) was an investigator-initiated 2-center, proof-of-concept, phase II clinical study with a randomized, double-blinded, placebo-controlled design. The main inclusion criteria were magnetic resonance imaging-verified acute ischemic stroke, moderate to severe neurological deficit (National Institutes of Health Stroke Scale score of ≥4), and treatment with thrombolysis within 4.5 hours of onset. Participants were randomly assigned in the ratio 1:1 to either 220 mg of intravenous theophylline or placebo. The co-primary outcomes were early clinical improvement on the National Institutes of Health Stroke Scale score and infarct growth on magnetic resonance imaging at 24-hour follow-up.
RESULTS
Theophylline as an add-on to thrombolytic therapy improved the National Institutes of Health Stroke Scale score at 24 hours by mean 4.7 points (SD, 5.6) compared with an improvement of 1.3 points (SD, 7.5) in the control group ( P =0.044). Mean infarct growth was 141.6% (SD, 126.5) and 104.1% (SD, 62.5) in the theophylline and control groups, respectively ( P =0.146). Functional independence at 90 days was 61% in the theophylline group and 58% in the control group ( P =0.802).
CONCLUSIONS
This proof-of-concept trial investigated theophylline administration as an add-on to thrombolytic therapy in acute ischemic stroke. The co-primary end points early clinical improvement and infarct growth at 24-hour follow-up were not significantly different after post hoc correction for multiplicity (Bonferroni technique). The small study size precludes a conclusion as to whether theophylline has a neuroprotective effect but provides a promising clinical signal that may support a future clinical trial. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: EudraCT number 2013-001989-42.",2020,The co-primary end points early clinical improvement and infarct growth at 24-hour follow-up were not significantly different after post hoc correction for multiplicity (Bonferroni technique).,"['acute ischemic stroke', 'acute ischemic stroke patients', 'Acute Ischemic Stroke', 'acute ischemic stroke, moderate to severe neurological deficit (National Institutes of Health Stroke Scale score of ≥4), and treatment with thrombolysis within 4.5 hours of onset']","['Placebo', 'vasoactive agent theophylline', 'Theophylline', 'theophylline or placebo', 'theophylline', 'placebo']","['Mean infarct growth', 'Functional independence', 'National Institutes of Health Stroke Scale score and infarct growth on magnetic resonance imaging at 24-hour follow-up', 'infarct growth', 'National Institutes of Health Stroke Scale score']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0039771', 'cui_str': 'Theophylline'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.545742,The co-primary end points early clinical improvement and infarct growth at 24-hour follow-up were not significantly different after post hoc correction for multiplicity (Bonferroni technique).,"[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Modrau', 'Affiliation': 'Departments of Neurology (B.M., F.W.B.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Grethe', 'Initials': 'G', 'LastName': 'Andersen', 'Affiliation': 'Departments of Neurology (G.A., N.H.), Aarhus University Hospital, Denmark.'}, {'ForeName': 'Irene Klærke', 'Initials': 'IK', 'LastName': 'Mikkelsen', 'Affiliation': 'Centre of Functionally Integrative Neuroscience, Aarhus University, Denmark (I.K.M., A.N., M.B.H., K.M., L.Ø.).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Nielsen', 'Affiliation': 'Centre of Functionally Integrative Neuroscience, Aarhus University, Denmark (I.K.M., A.N., M.B.H., K.M., L.Ø.).'}, {'ForeName': 'Mikkel Bo', 'Initials': 'MB', 'LastName': 'Hansen', 'Affiliation': 'Centre of Functionally Integrative Neuroscience, Aarhus University, Denmark (I.K.M., A.N., M.B.H., K.M., L.Ø.).'}, {'ForeName': 'Martin Berg', 'Initials': 'MB', 'LastName': 'Johansen', 'Affiliation': 'Unit of Clinical Biostatistics (M.B.J.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Helle Wulf', 'Initials': 'HW', 'LastName': 'Eskildsen', 'Affiliation': 'Neuroradiology (H.W.E., J.P.P., Y.Y.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Jan Plougmann', 'Initials': 'JP', 'LastName': 'Povlsen', 'Affiliation': 'Neuroradiology (H.W.E., J.P.P., Y.Y.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Yavarian', 'Affiliation': 'Neuroradiology (H.W.E., J.P.P., Y.Y.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mouridsen', 'Affiliation': 'Centre of Functionally Integrative Neuroscience, Aarhus University, Denmark (I.K.M., A.N., M.B.H., K.M., L.Ø.).'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Neuroradiology (L.Ø.), Aarhus University Hospital, Denmark.'}, {'ForeName': 'Flemming Winther', 'Initials': 'FW', 'LastName': 'Bach', 'Affiliation': 'Departments of Neurology (B.M., F.W.B.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Hjort', 'Affiliation': 'Departments of Neurology (G.A., N.H.), Aarhus University Hospital, Denmark.'}]",Stroke,['10.1161/STROKEAHA.119.027446']
1100,32576229,"Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials.","BACKGROUND
Migraine clinical profile may change with age, making it necessary to verify that migraine treatments are equally safe and effective in older patients. These analyses evaluated the effects of patient age on the pharmacokinetics (PK), efficacy, and safety of galcanezumab for prevention of migraine.
METHODS
Analyses included efficacy data from three double-blind phase 3 clinical trials: two 6-month studies in episodic migraine (EVOLVE-1, EVOLVE-2: N = 1773) and one 3-month study in chronic migraine (REGAIN:N = 1113). Patients were randomized 2:1:1 to placebo, galcanezumab 120 mg, or galcanezumab 240 mg. Safety and PK data included additional phase 2 and phase 3 trials for a larger sample size of patients > 60 years (range = 18-65 for all studies). Subgroup analyses assessed efficacy measures, adverse event (AE) occurrence, and cardiovascular measurement changes by patient age group. Galcanezumab PK were evaluated using a population analysis approach, where age was examined as a potential covariate on apparent clearance (CL/F) and apparent volume of distribution (V/F) of galcanezumab.
RESULTS
Numbers of baseline monthly migraine headache days were similar across age groups. There were no statistically significant treatment-by-age group interactions for any efficacy measures, except in episodic migraine studies where older patients appeared to have a larger reduction than younger patients in the number of monthly migraine headache days with acute medication use. Age (18-65) had a minimal effect on CL/F, and no effect on V/F. Galcanezumab-treated patients ≥60 years experienced no clinically meaningful increases in blood pressure and no increased frequency in treatment-emergent AEs, discontinuations due to AEs, serious adverse events (SAEs) overall, or cardiovascular SAEs, compared to age-matched placebo-treated patients.
CONCLUSIONS
Age (up to 65 years) does not affect efficacy in migraine prevention and has no clinically meaningful influence on galcanezumab PK to warrant dose adjustment. Furthermore, older galcanezumab-treated patients experienced no increases in frequency of AEs or increases in blood pressure compared with age-matched placebo-treated patients.
TRIAL REGISTRATIONS
EVOLVE-1 (NCT02614183, registered 23 November 2015), EVOLVE-2 (NCT02614196, 23 November 2015), REGAIN (NCT02614261, 23 November 2015), ART-01 (NCT01625988, 20 June 2012, ), I5Q-MC-CGAB (NCT02163993, 12 June 2014, ), I5Q-MC-CGAJ (NCT02614287, 23 November 2015, ), all retrospectively registered.",2020,"There were no statistically significant treatment-by-age group interactions for any efficacy measures, except in episodic migraine studies where older patients appeared to have a larger reduction than younger patients in the number of monthly migraine headache days with acute medication use.","['adult patients with migraine', 'episodic migraine (EVOLVE-1, EVOLVE-2: N\xa0=\u20091773) and one 3-month study in chronic migraine (REGAIN:N\xa0=\u20091113', 'larger sample size of patients >\u200960\u2009years (range\u2009=\u200918-65 for all studies', 'older patients']","['galcanezumab', 'Galcanezumab PK', 'placebo, galcanezumab 120\u2009mg, or galcanezumab 240\u2009mg']","['pharmacokinetics (PK), efficacy, and safety', 'blood pressure', 'frequency in treatment-emergent AEs, discontinuations due to AEs, serious adverse events (SAEs) overall, or cardiovascular SAEs', 'pharmacokinetics, efficacy, and safety', 'efficacy measures, adverse event (AE) occurrence, and cardiovascular measurement changes', 'frequency of AEs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.113351,"There were no statistically significant treatment-by-age group interactions for any efficacy measures, except in episodic migraine studies where older patients appeared to have a larger reduction than younger patients in the number of monthly migraine headache days with acute medication use.","[{'ForeName': 'Virginia L', 'Initials': 'VL', 'LastName': 'Stauffer', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA. vstauffer@lilly.com.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Turner', 'Affiliation': 'Center for Headache Care and Research, Island Neurological Associates, a division of ProHEALTHcare Associates, Plainview, NY, USA.'}, {'ForeName': 'Phebe', 'Initials': 'P', 'LastName': 'Kemmer', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Kielbasa', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Day', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Port', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Quinlan', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Camporeale', 'Affiliation': 'Eli Lilly Italia, Sesto Fiorentino, Italy.'}]",The journal of headache and pain,['10.1186/s10194-020-01148-9']
1101,32445052,"PPARγ activation by pioglitazone does not suppress cravings for alcohol, and is associated with a risk of myopathy in treatment seeking alcohol dependent patients: a randomized controlled proof of principle study.","RATIONALE
Proinflammatory processes have been implicated in alcohol addiction, craving, and relapse, while studies in experimental animals have suggested that activation of peroxisome proliferator-activated receptor gamma (PPARγ) inhibits proinflammatory signaling. Accordingly, it is hypothesized that medications with PPARγ activity may have therapeutic potential in alcohol dependence.
OBJECTIVES
We conducted a double-blind, placebo-controlled mechanistic proof of principle study in alcohol-dependent inpatients to investigate the effect of pioglitazone on alcohol craving.
METHODS
Participants were treated for withdrawal, if needed, and then randomized to pioglitazone (target dose 45 mg/day) or placebo. Once at target dose, they completed two experimental manipulations: guided imagery, which used personalized auditory scripts to induce alcohol cravings, and a low-dose challenge with i.v. lipopolysaccharide (LPS; 0.8 ng/kg) or placebo, on two separate sessions, in counterbalanced order. Behavioral and endocrine responses as well as CSF levels of proinflammatory cytokines were evaluated.
RESULTS
The study was prematurely terminated after randomization of 16 subjects, following an independent review that established a high risk of myopathy in the active treatment group. Analysis of those who completed the study indicated that pioglitazone was associated with elevated, rather than suppressed alcohol cravings in response to alcohol-associated stimuli. LPS did not induce cravings for alcohol and thus did not lend itself to evaluating pioglitazone effects; however, pioglitazone increased the neuroendocrine stress response to LPS. CSF levels of IL-6, TNF-α, or MCP-1 were unaffected by pioglitazone treatment.
CONCLUSIONS
Both safety and efficacy biomarker data suggest that pioglitazone lacks potential as a medication for the treatment of alcohol dependence.
CLINICAL TRIAL REGISTRATION
NCT01631630.",2020,"CSF levels of IL-6, TNF-α, or MCP-1 were unaffected by pioglitazone treatment.
",['Participants'],"['pioglitazone', 'LPS', 'lipopolysaccharide', 'placebo']","['alcohol cravings', 'CSF levels of proinflammatory cytokines', 'Behavioral and endocrine responses', 'CSF levels of IL-6, TNF-α, or MCP-1']",[],"[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}]",,0.162741,"CSF levels of IL-6, TNF-α, or MCP-1 were unaffected by pioglitazone treatment.
","[{'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Schwandt', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, 10 Center Drive, CRC 1-5330, Bethesda, MD, 20892, USA. melanies@mail.nih.gov.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Diazgranados', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, 10 Center Drive, CRC 1-5330, Bethesda, MD, 20892, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Umhau', 'Affiliation': 'Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration, Washington, DC, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Kwako', 'Affiliation': 'Division of Treatment and Recovery Research, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'George', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, 10 Center Drive, CRC 1-5330, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Center for Social and Affective Neuroscience, Linköping University, Linköping, Sweden.'}]",Psychopharmacology,['10.1007/s00213-020-05540-w']
1102,32446170,"Independent and combined effect of home-based progressive resistance training and nutritional supplementation on muscle strength, muscle mass and physical function in dynapenic older adults with low protein intake: A randomized controlled trial.","BACKGROUND
With the aging phenomenon, there is growing interest in developing effective strategies to counteract dynapenia, the age-related loss of muscle strength. The positive effect of progressive resistance training on muscle strength is well known, however, the effect of nutritional supplementation or its synergistic effect along with exercise on muscle strength is not a consensus in the literature, especially in populations with low protein intake.
METHODS
We analyzed the muscle strength (handgrip strength and sit-to-stand test), muscle mass, body mass index, insulin resistance, and physical function (gait speed, timed up & go test, and single-leg-stance test) of 69 dynapenic older adults with low protein intake, before and after the intervention period of three months. The participants were randomly allocated into four groups: resistance training, supplementation, resistance training plus supplementation, and control.
RESULTS
There was a significant group x time interaction on the following outcome measures: handgrip strength (p < 0.001), gait speed (p = 0.023), and sit-to-stand test (p < 0.001). Considering the outcomes that showed a significant difference between and within groups, only the resistance training group and the resistance training plus supplementation group showed a large effect size in handgrip strength, gait speed, and sit-to-stand test, whereas the supplementation group showed a moderate effect size in gait speed. After the intervention period, there was no difference between the resistance training and the resistance training plus supplementation groups.
CONCLUSION
This study reinforces the value of resistance training in improving muscle strength. The nutritional supplementation added no further benefits in this specific population. Registration number at the Brazilian registry of clinical trials: RBR-4HRQJF.",2020,"There was a significant group x time interaction on the following outcome measures: handgrip strength (p < 0.001), gait speed (p = 0.023), and sit-to-stand test (","['dynapenic older adults with low protein intake', '69 dynapenic older adults with low protein intake, before and after the intervention period of three months']","['home-based progressive resistance training and nutritional supplementation', 'progressive resistance training', 'resistance training, supplementation, resistance training plus supplementation, and control']","['muscle strength (handgrip strength and sit-to-stand test), muscle mass, body mass index, insulin resistance, and physical function (gait speed, timed up & go test, and single-leg-stance test', 'gait speed', 'sit-to-stand test ', 'muscle strength, muscle mass and physical function', 'handgrip strength', 'moderate effect size in gait speed', 'handgrip strength, gait speed, and sit-to-stand test']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082119', 'cui_str': 'Three months'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.0382378,"There was a significant group x time interaction on the following outcome measures: handgrip strength (p < 0.001), gait speed (p = 0.023), and sit-to-stand test (","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'de Carvalho Bastone', 'Affiliation': 'Postgraduate Program in Reabilitation and Functional Performance, Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: ale.bastone@gmail.com.'}, {'ForeName': 'Luciana Neri', 'Initials': 'LN', 'LastName': 'Nobre', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: lunerinobre@yahoo.com.br.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'de Souza Moreira', 'Affiliation': 'Postgraduate Program in Public Health - Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil. Electronic address: onurbsm@yahoo.com.br.'}, {'ForeName': 'Iramaya Francielle', 'Initials': 'IF', 'LastName': 'Rosa', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: iramayafranciellerosa@hotmail.com.'}, {'ForeName': 'Gabrielle Bemfica', 'Initials': 'GB', 'LastName': 'Ferreira', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: gabi_bferreira@hotmail.com.'}, {'ForeName': 'Dayane Deyse Lee', 'Initials': 'DDL', 'LastName': 'Santos', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: dayanedls@hotmail.com.'}, {'ForeName': 'Nancy Krysna Sancha Silva', 'Initials': 'NKSS', 'LastName': 'Monteiro', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: krysnancymonteiro@gmail.com.'}, {'ForeName': 'Michelle Dullya', 'Initials': 'MD', 'LastName': 'Alves', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: mih.dullya@gmail.com.'}, {'ForeName': 'Rômulo Amaral', 'Initials': 'RA', 'LastName': 'Gandra', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: romulogandra@yahoo.com.br.'}, {'ForeName': 'Elane Marinho', 'Initials': 'EM', 'LastName': 'de Lira', 'Affiliation': 'Postgraduate Program in Reabilitation and Functional Performance, Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: e.lira.fisio@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104098']
1103,32446172,Effects of 'participatory group-based care management' on wellbeing of older people living alone: a randomized controlled trial.,"BACKGROUND AND OBJECTIVES
More knowledge is needed of the effectiveness of complex interventions that aim to promote the wellbeing of older people. This study examines the effects of 'participatory group-based care management' conducted among community-dwelling older adults living alone in Central and Eastern Finland. The intervention aimed to promote wellbeing and quality of life (QoL) using a needs-based and participatory approach.
METHODS
The study was carried out as a randomized control trial (intervention group n = 185, control group n = 207). In this article, baseline and 6-month follow-up surveys were used. QoL (WHOQOL-Bref instrument), loneliness (Revised UCLA Loneliness Scale; single-item question), and trust (two items of generalized trust and six items of institutional trust) were used as outcome measurements, and generalized estimating equations (GEE) modeling as the analysis method. Both per-protocol and intention-to-treat analyses were applied.
RESULTS
According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline. Additionally, the intervention enhanced trust in other people and some dimensions of institutional trust. The intention-to-treat analysis did not result in any significant effects on QoL or loneliness, but some small positive changes in institutional trust were found.
CONCLUSIONS
Based on some evidence of small positive effects, the intervention may be beneficial in alleviating loneliness and enhancing trust among older people living alone. Because of the contradictory results, more research is needed to examine the complexity of 'participatory group-based care management´ from the perspective of process evaluation.",2020,"According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline.","['older people', 'community-dwelling older adults living alone in Central and Eastern Finland', 'older people living alone']",['participatory group-based care management'],"['QoL or loneliness', 'wellbeing and quality of life (QoL', 'QoL. Loneliness', 'QoL (WHOQOL-Bref instrument), loneliness (Revised UCLA Loneliness Scale; single-item question), and trust (two items of generalized trust and six items of institutional trust']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439044', 'cui_str': 'Lives alone'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0856593,"According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline.","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Ristolainen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Kannasoja', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Tiilikainen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hakala', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Närhi', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Rissanen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104095']
1104,32454078,Situated food safety behavior.,"Previous studies indicate that many consumers eat rare hamburgers and that information about microbiological hazards related to undercooked meat does not necessarily lead to changed behavior. With this study we aim to investigate whether consumers' willingness to eat hamburgers, both risky and safe, depends on the situation where they are confronted with the food. A representative sample of 1046 Norwegian consumers participated in a web experiment. Participants were randomly divided into four groups. Each group was told to imagine a specific eating situation (at their friend's place, at home, at a restaurant abroad, at a domestic restaurant). Four pictures of hamburgers (rare, medium rare, medium, well-done) were presented in randomized order, and participants rated their intentions to eat each hamburger. Situated risk perception was measured as the stated likelihood of food poisoning from consuming hamburgers in eight different situations. The results show that both risk perception and risk taking vary depending on the situation. In general, participants perceive their own home to be the safest place to consume a hamburger, but they are significantly more likely to consume an undercooked hamburger when at a friend's place. These findings indicate that situations play an important role for consumers' likelihood of eating unsafe food, and that risk taking does not always follow risk perception. That risk taking is elevated in situations that may have social consequences should be taken into consideration when developing food safety strategies.",2020,"These findings indicate that situations play an important role for consumers' likelihood of eating unsafe food, and that risk taking does not always follow risk perception.",['1046 Norwegian consumers participated in a web experiment'],[],['Situated risk perception'],"[{'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",1046.0,0.0220725,"These findings indicate that situations play an important role for consumers' likelihood of eating unsafe food, and that risk taking does not always follow risk perception.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Veflen', 'Affiliation': 'BI Norwegian Business School, Norway; Nofima, Norway. Electronic address: nina.veflen@bi.no.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Røssvoll', 'Affiliation': 'Nofima, Norway.'}, {'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Langsrud', 'Affiliation': 'Nofima, Norway.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Scholderer', 'Affiliation': 'NMBU, Norwegian University of Life Sciences, Norway; University of Zürich, Switzerland.'}]",Appetite,['10.1016/j.appet.2020.104751']
1105,32457012,Metoclopramide Reduces Fluoroscopy and Procedure Time during Gastrojejunostomy Tube Placement: A Placebo-Controlled Trial.,"PURPOSE
To determine whether a single 10-mg intravenous dose of the promotility agent metoclopramide reduces the fluoroscopy time, radiation dose, and procedure time required for gastrojejunostomy (GJ) tube placement.
METHODS
This prospective, randomized, double-blind, placebo-controlled trial enrolled consecutive patients who underwent primary GJ tube placement at a single institution from April 10, 2018, to October 3, 2019. Exclusion criteria included age less than 18 years, inability to obtain consent, metoclopramide allergy or contraindication, and altered pyloric anatomy. Average fluoroscopy times, radiation doses, and procedure times were compared using t-tests. The full study protocol can be found at www.clinicaltrials.gov (NCT03331965).
RESULTS
Of 110 participants randomized 1:1, 45 received metoclopramide and 51 received placebo and underwent GJ tube placement (38 females and 58 males; mean age, 55 ± 18 years). Demographics of the metoclopramide and placebo groups were similar. The fluoroscopy time required to advance a guide wire through the pylorus averaged 1.6 minutes (range, 0.3-10.1 minutes) in the metoclopramide group versus 4.1 minutes (range, 0.2-27.3 minutes) in the placebo group (P = .002). Total procedure fluoroscopy time averaged 5.8 minutes (range, 1.5-16.2 minutes) for the metoclopramide group versus 8.8 minutes (range, 2.8-29.7 minutes) for the placebo group (P = .002). Air kerma averaged 91 mGy (range, 13-354 mGy) for the metoclopramide group versus 130 mGy (range, 24-525 mGy) for the placebo group (P = .04). Total procedure time averaged 16.4 minutes (range, 8-51 minutes) for the metoclopramide group versus 19.9 minutes (range, 6-53 minutes) for the placebo group (P = .04). There were no drug-related adverse events and no significant differences in procedure-related complications.
CONCLUSIONS
A single dose of metoclopramide reduced fluoroscopy time by 34%, radiation dose by 30%, and procedure time by 17% during GJ tube placement.",2020,"Air kerma averaged 91 mGy (range, 13-354 mGy) for the metoclopramide group versus 130 mGy (range, 24-525 mGy) for the placebo group (P = .04).","['consecutive patients who underwent primary GJ tube placement at a single institution from April 10, 2018, to October 3, 2019', '110 participants randomized 1:1, 45 received', 'Exclusion criteria included age less than 18 years, inability to obtain consent, metoclopramide allergy or contraindication, and altered pyloric anatomy', '38 females and 58 males; mean age, 55 ± 18 years']","['metoclopramide and placebo', 'Placebo', 'Metoclopramide', 'metoclopramide', 'GJ tube placement', 'placebo']","['procedure-related complications', 'fluoroscopy time, radiation dose, and procedure time required for gastrojejunostomy (GJ) tube placement', 'Total procedure time', 'Average fluoroscopy times, radiation doses, and procedure times', 'fluoroscopy time', 'Total procedure fluoroscopy time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3880870', 'cui_str': 'Gastrojejunostomy tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1532670', 'cui_str': 'Obtaining consent'}, {'cui': 'C0570599', 'cui_str': 'Allergy to metoclopramide'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034196', 'cui_str': 'Pyloric structure of stomach'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3880870', 'cui_str': 'Gastrojejunostomy tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3880870', 'cui_str': 'Gastrojejunostomy tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",110.0,0.369738,"Air kerma averaged 91 mGy (range, 13-354 mGy) for the metoclopramide group versus 130 mGy (range, 24-525 mGy) for the placebo group (P = .04).","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'DuRocher', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Tony P', 'Initials': 'TP', 'LastName': 'Smith', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gazda', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Olivas', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Whited', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Langston', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Martin', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'Charles Y', 'Initials': 'CY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ronald', 'Affiliation': 'Department of Radiology, Division of Vascular & Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Road, Durham, NC 27710. Electronic address: james.ronald@duke.edu.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2020.02.028']
1106,32457075,Cholinergic Modulation of Binocular Vision.,"The endogenous neurotransmitter acetylcholine (ACh) is known to affect the excitatory/inhibitory (E/I) balance of primate visual cortex, enhancing feedforward thalamocortical gain while suppressing corticocortical synapses. Recent advances in the study of the human visual system suggest that ACh is a likely component underlying interocular interactions. However, our understanding of its precise role in binocular processes is currently lacking. Here we use binocular rivalry as a probe of interocular dynamics to determine ACh's effects, via the acetylcholinesterase inhibitor (AChEI) donepezil, on the binocular visual system. A total of 23 subjects (13 male) completed two crossover experimental sessions where binocular rivalry measurements were obtained before and after taking either donepezil (5 mg) or a placebo (lactose) pill. We report that enhanced cholinergic potentiation attenuates perceptual suppression during binocular rivalry, reducing the overall rate of interocular competition while enhancing the visibility of superimposition mixed percepts. Considering recent evidence that perceptual suppression during binocular rivalry is causally modulated by the inhibitory neurotransmitter GABA, our results suggest that cholinergic activity counteracts the effect of GABA with regards to interocular dynamics and may modulate the inhibitory drive within the visual cortex. SIGNIFICANCE STATEMENT Our research demonstrates that the cholinergic system is implicated in modulating binocular interactions in the human visual cortex. Potentiating the transmission of acetylcholine (ACh) via the cholinergic drug donepezil reduces the extent to which the eyes compete for perceptual dominance when presented two separate, incongruent images.",2020,"Increasing the potentiation of acetylcholine via the cholinergic drug donepezil reduces the extent to which the eyes compete for perceptual dominance when presented two separate, incongruent images.",['23 Subjects (13 male'],"['placebo (lactose) pill', 'acetylcholinesterase inhibitor (AChEI) donepezil ', 'acetylcholine', 'donepezil']",['binocular rivalry measurements'],"[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0001046', 'cui_str': 'Acetylcholinesterase inhibitor'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",23.0,0.0594407,"Increasing the potentiation of acetylcholine via the cholinergic drug donepezil reduces the extent to which the eyes compete for perceptual dominance when presented two separate, incongruent images.","[{'ForeName': 'Yasha', 'Initials': 'Y', 'LastName': 'Sheynin', 'Affiliation': 'McGill Vision Research, McGill University, Montréal, Quebec H3G 1A4, Canada.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Rosa-Neto', 'Affiliation': 'Douglas Mental Health University Institute, McGill University, Montréal, Quebec H4H 1R3, Canada.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Hess', 'Affiliation': 'McGill Vision Research, McGill University, Montréal, Quebec H3G 1A4, Canada robert.hess@mcgill.ca elvire.vaucher@umontreal.ca.'}, {'ForeName': 'Elvire', 'Initials': 'E', 'LastName': 'Vaucher', 'Affiliation': ""Laboratoire de Neurobiologie de la Cognition Visuelle, École d'Optométrie, Université de Montréal, Montréal, Quebec H3T 1P1, Canada robert.hess@mcgill.ca elvire.vaucher@umontreal.ca.""}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.2484-19.2020']
1107,32460699,"Dexmedetomidine for prevention of postoperative pulmonary complications in patients after oral and maxillofacial surgery with fibular free flap reconstruction:a prospective, double-blind, randomized, placebo-controlled trial.","BACKGROUND
Postoperative pulmonary complications (PPCs) are common and significant problems for oral and maxillofacial surgery patients. Dexmedetomidine (DEX), an α 2 -adrenoreceptor agonist, has been proven having lung protection effects. However, since now, there has not been final conclusion about whether DEX can reduce the incidence of PPCs. We hypothesize that, in oral and maxillofacial surgery with fibular free flap reconstruction patients, DEX may decrease the incidence of PPCs.
METHODS
This was a prospective, double-blind, randomized, placebo-controlled, single-centered trial with two parallel arms. A total of 160 patients at intermediate-to-high risk of PPCs undergoing oral and maxillofacial surgery with fibular free flap reconstruction and tracheotomy were enrolled and randomized to receive continuous infusion of either DEX or placebo (normal saline). 0.4 μg/kg of DEX was given over 10mins as an initial dose followed by a maintaining dose of 0.4 μg/kg/h till the second day morning after surgery. At the same time, the normal saline was administered a similar quantity. The primary outcome was the incidence of PPCs according to Clavien-Dindo score within 7 days after surgery.
RESULTS
The two groups had similar characteristics at baseline. 18(22.5%) of 80 patients administered DEX, and 32(40.0%) of 80 patient administered placebo experienced PPCs within the first 7 days after surgery (relative risk [RR] 0.563,95% confidence interval [CI] 0.346-0.916; P = 0.017). In the first 7 days after surgery, the DEX group had a lower incidence of PPCs and a better postoperative survival probability (Log-rank test, P = 0.019), and was less prone to occur PPCs (Cox regression, P = 0.025, HR = 0.516). When the total dose of DEX was more than 328 μg, the patients were unlikely to have PPCs (ROC curve, AUC = 0.614, P = 0.009).
CONCLUSIONS
For patients undergoing oral and maxillofacial surgery with fibular free flap reconstruction and tracheotomy who were at intermediate or high risk of developing PPCs, continuous infusion of DEX could decrease the occurrence of PPCs during the first 7 days after surgery and shorten the length of hospital stay after surgery, but did not increase the prevalence of bradycardia or hypotension.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, www.chictr.org.cn, number: ChiCTR1800016153; Registered on May 15, 2018.",2020,"In the first 7 days after surgery, the DEX group had a lower incidence of PPCs and a better postoperative survival probability (Log-rank test, P = 0.019), and was less prone to occur PPCs (Cox regression, P = 0.025, HR = 0.516).","['160 patients at intermediate-to-high risk of PPCs undergoing oral and maxillofacial surgery with fibular free flap reconstruction and tracheotomy', 'number', 'patients after oral and maxillofacial surgery with fibular free flap reconstruction']","['DEX or placebo (normal saline', 'DEX', 'Dexmedetomidine', 'Dexmedetomidine (DEX', 'maxillofacial surgery with fibular free flap reconstruction and tracheotomy', 'placebo']","['postoperative pulmonary complications', 'incidence of PPCs according to Clavien-Dindo score', 'length of hospital stay', 'occurrence of PPCs', 'prevalence of bradycardia or hypotension', 'incidence of PPCs', 'postoperative survival probability']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0016068', 'cui_str': 'Bone structure of fibula'}, {'cui': 'C0411582', 'cui_str': 'Reconstruction with free flap'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0016068', 'cui_str': 'Bone structure of fibula'}, {'cui': 'C0411582', 'cui_str': 'Reconstruction with free flap'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",160.0,0.736349,"In the first 7 days after surgery, the DEX group had a lower incidence of PPCs and a better postoperative survival probability (Log-rank test, P = 0.019), and was less prone to occur PPCs (Cox regression, P = 0.025, HR = 0.516).","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Peking University Third Hospital, Beijing, 100191, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Critical Care Medicine, Peking University Third Hospital, Beijing, 100191, China. 3917798@qq.com.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Peking University Hospital of Stomatology, Beijing, 100081, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, Peking University Hospital of Stomatology, Beijing, 100081, China.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Peking University Hospital of Stomatology, Beijing, 100081, China. kqyangxudong@163.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01045-3']
1108,32466746,Infraclavicular nerve block reduces postoperative pain after distal radial fracture fixation: a randomized controlled trial.,"BACKGROUND
It is unclear whether regional anesthesia with infraclavicular nerve block or general anesthesia provides better postoperative analgesia after distal radial fracture fixation, especially when combined with regular postoperative analgesic medications. The aim of this study was to compare the postoperative analgesic effects of regional versus general anesthesia.
METHODS
In this prospective, observer blinded, randomized controlled trial, 52 patients undergoing distal radial fracture fixation received either general anesthesia (n = 26) or regional anesthesia (infraclavicular nerve block, n = 26). Numerical rating scale pain scores, analgesic consumption, patient satisfaction, adverse effects, upper limb functional scores (Patient-Rated Wrist Evaluation, QuickDASH), health related quality of life (SF12v2), and psychological status were evaluated after surgery.
RESULT
Regional anesthesia was associated with significantly lower pain scores both at rest and with movement on arrival to the post-anesthetic care unit; and at 1, 2, 24 and 48 h after surgery (p ≤ 0.001 at rest and with movement). Morphine consumption in the post-anesthetic care unit was significantly lower in the regional anesthesia group (p<0.001). There were no differences in oral analgesic consumption. Regional anesthesia was associated with lower incidences of nausea (p = 0.004), and vomiting (p = 0.050). Patient satisfaction was higher in the regional anesthesia group (p = 0.003). There were no long-term differences in pain scores and other patient outcomes.
CONCLUSION
Regional anesthesia with ultrasound guided infraclavicular nerve block was associated with better acute pain relief after distal radial fracture fixation, and may be preferred over general anesthesia.
TRIAL REGISTRATION
Before subject enrollment, the study was registered at ClinicalTrials.gov (NCT03048214) on 9th February 2017.",2020,"Regional anesthesia with ultrasound guided infraclavicular nerve block was associated with better acute pain relief after distal radial fracture fixation, and may be preferred over general anesthesia.
","['after distal radial fracture fixation', '52 patients undergoing distal radial fracture fixation received either']","['Regional anesthesia with ultrasound guided infraclavicular nerve block', 'general anesthesia (n\u2009=\u200926) or regional anesthesia (infraclavicular nerve block, n\u2009=\u200926', 'Infraclavicular nerve block']","['Patient satisfaction', 'pain scores', 'postoperative pain', 'Numerical rating scale pain scores, analgesic consumption, patient satisfaction, adverse effects, upper limb functional scores (Patient-Rated Wrist Evaluation, QuickDASH), health related quality of life (SF12v2), and psychological status', 'vomiting', 'acute pain relief', 'oral analgesic consumption', 'Morphine consumption', 'nausea', 'postoperative analgesic effects']","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0230108', 'cui_str': 'Infraclavicular region structure'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",52.0,0.47479,"Regional anesthesia with ultrasound guided infraclavicular nerve block was associated with better acute pain relief after distal radial fracture fixation, and may be preferred over general anesthesia.
","[{'ForeName': 'Stanley S', 'Initials': 'SS', 'LastName': 'Wong', 'Affiliation': 'Laboratory and Clinical Research Institute for Pain, Department of Anaesthesiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Queen Mary Hospital, Room 424, Block K, 102, Pokfulam Road, Hong Kong SAR, China. wongstan@hku.hk.'}, {'ForeName': 'Wing S', 'Initials': 'WS', 'LastName': 'Chan', 'Affiliation': 'Laboratory and Clinical Research Institute for Pain, Department of Anaesthesiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Queen Mary Hospital, Room 424, Block K, 102, Pokfulam Road, Hong Kong SAR, China.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fang', 'Affiliation': 'Department of Orthopaedics and Traumatology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chi W', 'Initials': 'CW', 'LastName': 'Chan', 'Affiliation': 'Department of Anaesthesiology, Queen Mary Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Tak W', 'Initials': 'TW', 'LastName': 'Lau', 'Affiliation': 'Department of Orthopaedics and Traumatology, Queen Mary Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Leung', 'Affiliation': 'Department of Orthopaedics and Traumatology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chi W', 'Initials': 'CW', 'LastName': 'Cheung', 'Affiliation': 'Laboratory and Clinical Research Institute for Pain, Department of Anaesthesiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Queen Mary Hospital, Room 424, Block K, 102, Pokfulam Road, Hong Kong SAR, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01044-4']
1109,32590520,"Radiographical Comparison of Superior and Inferior Gluteal Vessels in ""Jackknife"" Versus Prone Positions: A Prospective, Self-Controlled Trial.","BACKGROUND
Mortality after gluteal augmentation with fat transfer techniques is extremely high. Placement of fat subcutaneously versus in the gluteal musculature, or both, are considerably debated. The purpose of this study was to radiographically show the anatomical difference in live subjects in different procedural positions: the flexed or ""Jack-knife"" versus prone positions.
METHODS
A total of ten females underwent Computerized Tomography (CT) scanning of the pelvis with venous phase run-off in both the ""Jack-knife"" and prone positions. A CT specialized radiologist then reviewed images and measured distances from the inferior and superior gluteal veins (IGV and SGV, respectively) to the skin and muscle. Three-dimensional (3D) imaging and analysis were also performed.
RESULTS
Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions. 3D modeling showed a significant reduction in the volume and SGV and IGV diameters when in the ""Jack-knife"" position.
CONCLUSIONS
When placed in the ""Jack-knife"" position for gluteal augmentation with fat transfer, extreme caution should be taken with the injecting cannula as the underlying muscle is only 2-3 centimeters deep. 3D analysis showed narrowed and reduced volume of gluteal vasculature when in the ""Jack-knife"" position; a possible indication of torsion or stretch on the vessel around the pelvic rim that could cause vein avulsion injury from the pressurized fat within the piriform space.",2020,"RESULTS
Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions.","['Jackknife"" Versus Prone Positions']","['Computerized Tomography (CT) scanning', 'flexed or ""Jack-knife"" versus prone positions']","['volume of gluteal vasculature', 'volume and SGV and IGV diameters']","[{'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",10.0,0.0267786,"RESULTS
Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions.","[{'ForeName': 'Connor W', 'Initials': 'CW', 'LastName': 'Barnes', 'Affiliation': ''}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Ford', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Harrington', 'Affiliation': ''}, {'ForeName': 'Rajendra P', 'Initials': 'RP', 'LastName': 'Kedar', 'Affiliation': ''}, {'ForeName': 'Thanh Q', 'Initials': 'TQ', 'LastName': 'Tran', 'Affiliation': ''}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Karlnoski', 'Affiliation': ''}, {'ForeName': 'Summer J', 'Initials': 'SJ', 'LastName': 'Decker', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Smith', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007151']
1110,32598257,"Selinexor (KPT-330), an Oral Selective Inhibitor of Nuclear Export (SINE) Compound, in Combination with FOLFOX in Patients with Metastatic Colorectal Cancer (mCRC) - Final Results of the Phase I Trial SENTINEL.","BACKGROUND
Selinexor is an oral Selective Inhibitor of Nuclear Export compound that specifically blocks Chromosomal Region Maintenance protein 1.
OBJECTIVE
To evaluate the safety and tolerability of escalating doses of selinexor plus 5-fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) in metastatic colorectal cancer (mCRC) patients.
METHODS
In this multicenter phase I trial, mCRC patients, eligible for oxaliplatin-based treatment, were enrolled to receive oral selinexor on days 1, 3, and 8 plus mFOLFOX6 every two weeks. Primary endpoint was the maximum tolerated dose. Secondary endpoints were toxicity, overall response rate, progression free survival, and overall survival.
RESULTS
Overall, 10 patients were enrolled, who had prior treatment with oxaliplatin (6/10), irinotecan (8/10), bevacizumab (6/10) or anti-EGFR therapy (5/10). Four consecutive patients received 40 mg selinexor plus mFOLFOX6. All four experienced dose-limiting toxicities and withdrew from the study after a median of two cycles. Thus, this dose level was regarded as toxic and no further patients were evaluated at this dose. Six patients were enrolled with 20 mg selinexor plus mFOLFOX6. Despite better tolerability, four patients withdrew (patient wish) after the first cycle and only two patients continued until disease progression. Most commonly reported treatment emergent adverse events were nausea (80%), diarrhea (70%), vomiting (60%), fatigue (60%), anorexia (40%), and impaired vision (40%). Due to the short treatment exposure, no relevant clinical activity was observed.
CONCLUSION
In patients with metastatic colorectal cancer, selinexor on this dose schedule plus mFOLFOX6 was not tolerable. Other dosing schedules or combinations may be evaluated. Clinical trial identifier NCT02384850.",2020,"Secondary endpoints were toxicity, overall response rate, progression free survival, and overall survival.
","['patients with metastatic colorectal cancer', 'mCRC patients, eligible for oxaliplatin-based treatment', 'metastatic colorectal cancer (mCRC) patients', '10 patients were enrolled, who had prior treatment with', 'Six patients were enrolled with 20 mg', 'Patients with Metastatic Colorectal Cancer (mCRC']","['40 mg selinexor plus mFOLFOX6', 'oxaliplatin', 'Selinexor (KPT-330), an Oral Selective Inhibitor of Nuclear Export ', 'bevacizumab (6/10) or anti-EGFR therapy', 'selinexor plus 5-fluorouracil, leucovorin and oxaliplatin (mFOLFOX6', 'selinexor plus mFOLFOX6', 'FOLFOX', 'irinotecan', 'oral selinexor']","['diarrhea', 'anorexia', 'fatigue', 'toxicity, overall response rate, progression free survival, and overall survival', 'safety and tolerability', 'vomiting', 'nausea', 'maximum tolerated dose', 'impaired vision']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C3852671', 'cui_str': 'Selinexor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C3640806', 'cui_str': 'KPT-330'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0887840', 'cui_str': 'Nuclear Export'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C3665347', 'cui_str': 'Visual impairment'}]",4.0,0.0785983,"Secondary endpoints were toxicity, overall response rate, progression free survival, and overall survival.
","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Nilsson', 'Affiliation': 'II. Medical Clinic and Polyclinic, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'II. Medical Clinic and Polyclinic, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rolfo', 'Affiliation': 'Phase I- Early Clinical Trials Unit, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Kranich', 'Affiliation': 'GSO Global Clinical Research B.V., Amsterdam, Netherlands.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mann', 'Affiliation': 'II. Medical Clinic and Polyclinic, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Papadimitriou', 'Affiliation': 'Phase I- Early Clinical Trials Unit, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Theile', 'Affiliation': 'GSO Gesellschaft für Studienmanagement und Onkologie mbH, Hamburg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Amberg', 'Affiliation': 'GSO Gesellschaft für Studienmanagement und Onkologie mbH, Hamburg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'II. Medical Clinic and Polyclinic, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Current cancer drug targets,['10.2174/1568009620666200628105727']
1111,32604401,Using prefrontal transcranial direct current stimulation (tDCS) to enhance proactive cognitive control in schizophrenia.,"The goal of this study was to use transcranial direct current stimulation (tDCS) to examine the role of the prefrontal cortex (PFC) in neural oscillatory activity associated with proactive cognitive control in schizophrenia. To do so, we tested the impact of PFC-targeted tDCS on behavioral and electrophysiological markers of proactive cognitive control engagement in individuals with schizophrenia. Using a within-participants, double-blinded, sham-controlled crossover design, we recorded EEG while participants with schizophrenia completed a proactive cognitive control task (the Dot Pattern Expectancy (DPX) Task), after receiving 20 min of active prefrontal stimulation at 2 mA or sham stimulation. We hypothesized that active stimulation would enhance proactive cognitive control, leading to changes in behavioral performance on the DPX task and in activity in the gamma frequency band during key periods of the task designed to tax proactive cognitive control. The results showed significant changes in the pattern of error rates and increases in EEG gamma power as a function of tDCS condition (active or sham), that were indicative of enhanced proactive cognitive control. These findings, considered alongside our previous work in healthy adults, provides novel support for the role gamma oscillations in proactive cognitive control and they suggest that frontal tDCS may be a promising approach to enhance proactive cognitive control in schizophrenia.",2020,"The results showed significant changes in the pattern of error rates and increases in EEG gamma power as a function of tDCS condition (active or sham), that were indicative of enhanced proactive cognitive control.","['healthy adults', 'schizophrenia', 'individuals with schizophrenia', 'participants with schizophrenia completed a']","['transcranial direct current stimulation (tDCS', 'proactive cognitive control task (the Dot Pattern Expectancy (DPX) Task), after receiving 20\u2009min of active prefrontal stimulation at 2\u2009mA or sham stimulation', 'PFC-targeted tDCS', 'prefrontal transcranial direct current stimulation (tDCS']",['pattern of error rates and increases in EEG gamma power'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]","[{'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]",,0.0402734,"The results showed significant changes in the pattern of error rates and increases in EEG gamma power as a function of tDCS condition (active or sham), that were indicative of enhanced proactive cognitive control.","[{'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Boudewyn', 'Affiliation': 'University of California, Santa Cruz, CA, USA. mboudewyn@ucsc.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Scangos', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Charan', 'Initials': 'C', 'LastName': 'Ranganath', 'Affiliation': 'University of California, Davis, CA, USA.'}, {'ForeName': 'Cameron S', 'Initials': 'CS', 'LastName': 'Carter', 'Affiliation': 'University of California, Davis, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0750-8']
1112,32611284,Alteplase for Acute Ischemic Stroke in Patients Aged >80 Years: Pooled Analyses of Individual Patient Data.,"BACKGROUND/PURPOSE
Expert guidelines specify no upper age limit for alteplase for thrombolysis of acute ischemic stroke (AIS) but, until recently, European regulatory criteria restricted its use to patients aged 18 to 80 years. We performed pooled analyses of randomized controlled trial (RCT) and registry data to evaluate the benefit-risk profile of alteplase for AIS among patients aged >80 years to support a regulatory application to lift the upper age restriction.
METHODS
Individual patient data were evaluated from 7 randomized trials of alteplase (0.9 mg/kg) versus placebo or open control for AIS, and the European SITS-UTMOST registry database. Clinical outcomes, including good functional outcome (score 0-1, modified Rankin Scale day 90 or Oxford Handicap Score day 180), were evaluated in the full RCT and registry populations, and specified age-based subgroups (≤80 or >80 years) who met existing European regulatory criteria for alteplase, excluding upper age restriction.
RESULTS
Regardless of treatment allocation, 90-day mortality was lower among RCT patients aged ≤80 versus >80 years who otherwise met existing European regulatory criteria (246/2405 [10.2%] versus 307/1028 [29.9%], respectively). Among patients aged >80 years, alteplase versus placebo was associated with a higher proportion of good stroke outcome (modified Rankin Scale score 0-1; 99/518 [19.1%] versus 67/510 [13.1%]; P =0.0109) and similar 90-day mortality (153/518 [29.5%] versus 154/510 [30.2%]; P =0.8382). The odds of a good stroke outcome following alteplase allocation in the full RCT population were independent of age ( P =0.7383). Good stroke outcome was reported for almost half (4821/11 169 [43.2%]) of the patients who received alteplase in routine practice. Outcomes in routine practice supported those achieved in RCTs.
CONCLUSIONS
Alteplase for AIS has a positive benefit-risk profile among patients aged >80 years when administered according to other regulatory criteria. Alteplase for AIS should be evaluated on an individual benefit-risk basis.",2020,"Among patients aged >80 years, alteplase versus placebo was associated with a higher proportion of good stroke outcome (modified Rankin Scale score 0-1; 99/518 [19.1%] versus 67/510 [13.1%]; P =0.0109) and similar 90-day mortality (153/518 [29.5%] versus 154/510 [30.2%]; P =0.8382).","['Individual patient data', 'patients aged >80 years', 'patients aged 18 to 80 years', 'Patients Aged']","['Alteplase', 'alteplase', 'placebo']","['good functional outcome', 'good stroke outcome (modified Rankin Scale score', '90-day mortality', 'Good stroke outcome']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.126515,"Among patients aged >80 years, alteplase versus placebo was associated with a higher proportion of good stroke outcome (modified Rankin Scale score 0-1; 99/518 [19.1%] versus 67/510 [13.1%]; P =0.0109) and similar 90-day mortality (153/518 [29.5%] versus 154/510 [30.2%]; P =0.8382).","[{'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Bluhmki', 'Affiliation': 'ADB Building, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany and Hochschule Biberach, University of Applied Sciences, Germany (E.B.).'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Danays', 'Affiliation': 'The Medical Department, Boehringer Ingelheim France SAS, Reims (T.D.).'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Biegert', 'Affiliation': 'The Biostatistics and Data Sciences Corp, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany (G.B.).'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Hacke', 'Affiliation': 'The Department of Neurology, University of Heidelberg, Germany (W.H.).'}, {'ForeName': 'Kennedy R', 'Initials': 'KR', 'LastName': 'Lees', 'Affiliation': 'The School of Medicine, Dentistry & Nursing, University of Glasgow, United Kingdom (K.R.L.).'}]",Stroke,['10.1161/STROKEAHA.119.028396']
1113,32622394,"Ambulatory management of primary spontaneous pneumothorax: an open-label, randomised controlled trial.","BACKGROUND
Primary spontaneous pneumothorax occurs in otherwise healthy young patients. Optimal management is not defined and often results in prolonged hospitalisation. Data on efficacy of ambulatory options are poor. We aimed to describe the duration of hospitalisation and safety of ambulatory management compared with standard care.
METHODS
In this open-label, randomised controlled trial, adults (aged 16-55 years) with symptomatic primary spontaneous pneumothorax were recruited from 24 UK hospitals during a period of 3 years. Patients were randomly assigned (1:1) to treatment with either an ambulatory device or standard guideline-based management (aspiration, standard chest tube insertion, or both). The primary outcome was total length of hospital stay including re-admission up to 30 days after randomisation. Patients with available data were included in the primary analysis and all assigned patients were included in the safety analysis. The trial was prospectively registered with the International Standard Randomised Clinical Trials Number, ISRCTN79151659.
FINDINGS
Of 776 patients screened between July, 2015, and March, 2019, 236 (30%) were randomly assigned to ambulatory care (n=117) and standard care (n=119). At day 30, the median hospitalisation was significantly shorter in the 114 patients with available data who received ambulatory treatment (0 days [IQR 0-3]) than in the 113 with available data who received standard care (4 days [IQR 0-8]; p<0·0001; median difference 2 days [95% CI 1-3]). 110 (47%) of 236 patients had adverse events, including 64 (55%) of 117 patients in the ambulatory care arm and 46 (39%) of 119 in the standard care arm. All 14 serious adverse events occurred in patients who received ambulatory care, eight (57%) of which were related to the intervention, including an enlarging pneumothorax, asymptomatic pulmonary oedema, and the device malfunctioning, leaking, or dislodging.
INTERPRETATION
Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events. This data suggests that primary spontaneous pneumothorax can be managed for outpatients, using ambulatory devices in those who require intervention.
FUNDING
UK National Institute for Health Research.",2020,"INTERPRETATION
Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events.","['Patients with available data were included in the primary analysis and all assigned patients were included in the safety analysis', '110 (47%) of 236 patients had adverse events, including 64 (55%) of 117 patients in the ambulatory care arm and 46 (39%) of 119 in the standard care arm', '776 patients screened between July, 2015, and March, 2019, 236 (30%) were randomly assigned to ambulatory care (n=117) and standard care (n=119', 'primary spontaneous pneumothorax', 'adults (aged 16-55 years) with symptomatic primary spontaneous pneumothorax were recruited from 24 UK hospitals during a period of 3 years', 'otherwise healthy young patients']","['ambulatory device or standard guideline-based management (aspiration, standard chest tube insertion, or both', 'ambulatory management compared with standard care']","['duration of hospitalisation including re-admissions', 'total length of hospital stay including re-admission', 'adverse events', 'median hospitalisation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1868193', 'cui_str': 'Primary spontaneous pneumothorax'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0189476', 'cui_str': 'Insertion of pleural tube drain'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.148264,"INTERPRETATION
Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events.","[{'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'Hallifax', 'Affiliation': 'Oxford Centre for Respiratory Medicine, University of Oxford, Oxford, UK. Electronic address: robert.hallifax@ndm.ox.ac.uk.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'McKeown', 'Affiliation': 'Royal Berkshire National Health Service (NHS) Foundation Trust, Reading, UK.'}, {'ForeName': 'Parthipan', 'Initials': 'P', 'LastName': 'Sivakumar', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Fairbairn', 'Affiliation': 'Queen Margaret Hospital, NHS Fife, Dunfermline, UK.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Peter', 'Affiliation': 'Royal United Hospitals Bath NHS Foundation Trust, Bath, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Leitch', 'Affiliation': 'Western General Hospital, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Knight', 'Affiliation': 'West Hertfordshire Hospitals NHS Trust, Watford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Stanton', 'Affiliation': 'Great Western Hospital NHS Foundation Trust, Swindon, UK.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Ijaz', 'Affiliation': 'University Hospitals of Morecambe Bay NHS Foundation Trust, Lancaster, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Marciniak', 'Affiliation': 'Department of Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cameron', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Amrithraj', 'Initials': 'A', 'LastName': 'Bhatta', 'Affiliation': 'Blackpool Fylde and Wyre Hospitals NHS Foundation Trust, Blackpool, UK.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Blyth', 'Affiliation': 'Queen Elizabeth University Hospital, Glasgow, UK; Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Reddy', 'Affiliation': 'Kettering General Hospital, Kettering, UK.'}, {'ForeName': 'Marie-Clare', 'Initials': 'MC', 'LastName': 'Harris', 'Affiliation': 'Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Maddekar', 'Affiliation': 'University Hospitals of North Midlands, Stoke-on-Trent, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'West', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Laskawiec-Szkonter', 'Affiliation': 'Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Corcoran', 'Affiliation': 'University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gerry', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Corran', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Harvey', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Miller', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Najib M', 'Initials': 'NM', 'LastName': 'Rahman', 'Affiliation': 'Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31043-6']
1114,32631651,A semiautomatic segmentation method for interstitial needles in intraoperative 3D transvaginal ultrasound images for high-dose-rate gynecologic brachytherapy of vaginal tumors.,"PURPOSE
The purpose of this study was to evaluate the use of a semiautomatic algorithm to simultaneously segment multiple high-dose-rate (HDR) gynecologic interstitial brachytherapy (ISBT) needles in three-dimensional (3D) transvaginal ultrasound (TVUS) images, with the aim of providing a clinically useful tool for intraoperative implant assessment.
METHODS AND MATERIALS
A needle segmentation algorithm previously developed for HDR prostate brachytherapy was adapted and extended to 3D TVUS images from gynecologic ISBT patients with vaginal tumors. Two patients were used for refining/validating the modified algorithm and five patients (8-12 needles/patient) were reserved as an unseen test data set. The images were filtered to enhance needle edges, using intensity peaks to generate feature points, and leveraged the randomized 3D Hough transform to identify candidate needle trajectories. Algorithmic segmentations were compared against manual segmentations and calculated dwell positions were evaluated.
RESULTS
All 50 test data set needles were successfully segmented with 96% of algorithmically segmented needles having angular differences <3° compared with manually segmented needles and the maximum Euclidean distance was <2.1 mm. The median distance between corresponding dwell positions was 0.77 mm with 86% of needles having maximum differences <3 mm. The mean segmentation time using the algorithm was <30 s/patient.
CONCLUSIONS
We successfully segmented multiple needles simultaneously in intraoperative 3D TVUS images from gynecologic HDR-ISBT patients with vaginal tumors and demonstrated the robustness of the algorithmic approach to image artifacts. This method provided accurate segmentations within a clinically efficient timeframe, providing the potential to be translated into intraoperative clinical use for implant assessment.",2020,All 50 test data set needles were successfully segmented with 96% of algorithmically segmented needles having angular differences <3° compared with manually segmented needles and the maximum Euclidean distance was <2.1 mm.,"['gynecologic HDR-ISBT patients with vaginal tumors', 'vaginal tumors', 'gynecologic ISBT patients with vaginal tumors']",['semiautomatic algorithm to simultaneously segment multiple high-dose-rate (HDR) gynecologic interstitial brachytherapy (ISBT) needles'],"['median distance', 'mean segmentation time']","[{'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1881237', 'cui_str': 'Interstitial brachytherapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042258', 'cui_str': 'Neoplasm of vagina'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C1881237', 'cui_str': 'Interstitial brachytherapy'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.027857,All 50 test data set needles were successfully segmented with 96% of algorithmically segmented needles having angular differences <3° compared with manually segmented needles and the maximum Euclidean distance was <2.1 mm.,"[{'ForeName': 'Jessica Robin', 'Initials': 'JR', 'LastName': 'Rodgers', 'Affiliation': 'School of Biomedical Engineering, The University of Western Ontario, London, Ontario, Canada; Robarts Research Institute, The University of Western Ontario, London, Ontario, Canada. Electronic address: jrodge23@uwo.ca.'}, {'ForeName': 'William Thomas', 'Initials': 'WT', 'LastName': 'Hrinivich', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Surry', 'Affiliation': 'Department of Medical Physics, London Regional Cancer Program, London, Ontario, Canada.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Velker', 'Affiliation': 'Department of Radiation Oncology, London Regional Cancer Program, London, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Radiation Oncology, London Regional Cancer Program, London, Ontario, Canada.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Fenster', 'Affiliation': 'School of Biomedical Engineering, The University of Western Ontario, London, Ontario, Canada; Robarts Research Institute, The University of Western Ontario, London, Ontario, Canada.'}]",Brachytherapy,['10.1016/j.brachy.2020.05.006']
1115,32638409,Dietary macronutrient regulation of acyl and desacyl ghrelin concentrations in children with Prader-Willi syndrome (PWS).,"BACKGROUND
The effects of dietary macronutrients on orexigenic and anorexigenic hormones in children are poorly understood.
OBJECTIVE
To explore effects of varying dietary macronutrients on appetite-regulating hormones [acyl ghrelin (AG) and desacyl ghrelin (DAG), glucagon-like peptide 1 (GLP-1), peptide tyrosine tyrosine (PYY) and insulin] in children with PWS and healthy children (HC).
DESIGN
Randomized, cross-over experiments compared two test diets [high protein-low carbohydrate (HP-LC) and high protein-low fat (HP-LF)] to a STANDARD meal (55% carbohydrate, 30% fat, 15% protein). Experiment 1 included ten children with PWS (median age 6.63 years; BMI z 1.05); experiment 2 had seven HC (median age 12.54 years; BMI z 0.95). Blood samples were collected at baseline and at 60-minute intervals for 4 hours. Independent linear mixed models were adjusted for age, sex and BMI z-score.
RESULTS
Fasting and post-prandial AG and DAG concentrations are elevated in PWS children; the ratio of AG/DAG is normal. Food consumption reduced AG and DAG concentrations in both PWS and HC. GLP-1 levels were higher in PWS after the HP-LC and HP-LF meals than the STANDARD meal (P = .02-0.04). The fasting proinsulin to insulin ratio (0.08 vs 0.05) was higher in children with PWS (P = .05) than in HC. Average appetite scores in HC declined after all three meals (P = .02) but were lower after the HP-LC and HP-LF meals than the STANDARD meal.
CONCLUSION
Altered processing of proinsulin and increased GLP-1 secretion in children with PWS after a high protein meal intake might enhance satiety and reduce energy intake.",2020,GLP-1 levels were higher in PWS after the HP-LC and HP-LF meals than the STANDARD meal (p = 0.02- 0.04).,"['children with PWS', 'children with Prader-Willi syndrome (PWS', 'children with PWS and healthy children (HC', 'Experiment 1 included ten children with PWS (median age 6.63y; BMI z 1.05); experiment 2 had seven HC (median age 12.54y; BMI z 0.95']","['varying dietary macronutrients', 'diets [High Protein-Low Carbohydrate (HP-LC) and High Protein-Low Fat (HP-LF', 'dietary macronutrients']","['Fasting and post-prandial AG and DAG concentrations', 'Blood samples', 'GLP-1 levels', 'GLP-1 secretion', 'fasting proinsulin to insulin ratio', 'Average appetite scores in HC', 'AG and DAG concentrations', 'satiety and reduce energy intake', 'appetite-regulating hormones [acyl ghrelin (AG) and desacyl ghrelin (DAG), glucagon-like peptide\xa01 (GLP-1), peptide tyrosine tyrosine (PYY), and insulin']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032897', 'cui_str': 'Prader-Willi syndrome'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4068754', 'cui_str': '1.05'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0011967', 'cui_str': '1,2,5,6-Dianhydrogalactitol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0033362', 'cui_str': 'Proinsulin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0965048', 'cui_str': 'ghrelin, des-n-octanoyl'}, {'cui': 'C0077599', 'cui_str': 'tyrosyltyrosine'}]",10.0,0.035134,GLP-1 levels were higher in PWS after the HP-LC and HP-LF meals than the STANDARD meal (p = 0.02- 0.04).,"[{'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Alsaif', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AL, Canada.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Pakseresht', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AL, Canada.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Mackenzie', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AL, Canada.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Gaylinn', 'Affiliation': 'Division of Endocrinology, Department of Medicine, School of Medicine, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Michael O', 'Initials': 'MO', 'LastName': 'Thorner', 'Affiliation': 'Division of Endocrinology, Department of Medicine, School of Medicine, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Freemark', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Field', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AL, Canada.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Prado', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AL, Canada.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Haqq', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AL, Canada.'}]",Clinical endocrinology,['10.1111/cen.14279']
1116,32640940,Impact of Goal-Directed Therapy on Delayed Ischemia After Aneurysmal Subarachnoid Hemorrhage: Randomized Controlled Trial.,"BACKGROUND AND PURPOSE
Delayed cerebral ischemia (DCI) is the most important cause for a poor clinical outcome after a subarachnoid hemorrhage. The aim of this study was to assess whether goal-directed hemodynamic therapy (GDHT), as compared to standard clinical care, reduces the rate of DCI after subarachnoid hemorrhage.
METHODS
We conducted a prospective randomized controlled trial. Patients >18 years of age with an aneurysmal subarachnoid hemorrhage were enrolled and randomly assigned to standard therapy or GDHT. Advanced hemodynamic monitoring and predefined GDHT algorithms were applied in the GDHT group. The primary end point was the occurrence of DCI. Functional outcome was assessed using the Glasgow Outcome Scale (GOS) 3 months after discharge.
RESULTS
In total, 108 patients were randomized to the control (n=54) or GDHT group (n=54). The primary outcome (DCI) occurred in 13% of the GDHT group and in 32% of the control group patients (odds ratio, 0.324 [95% CI, 0.11-0.86]; P =0.021). Even after adjustment for confounding parameters, GDHT was found to be superior to standard therapy (hazard ratio, 2.84 [95% CI, 1.18-6.86]; P =0.02). The GOS was assessed 3 months after discharge in 107 patients; it showed more patients with a low disability (GOS 5, minor or no deficits) than patients with higher deficits (GOS 1-4) in the GDHT group compared with the control group (GOS 5, 66% versus 44%; GOS 1-4, 34% versus 56%; P =0.025). There was no significant difference in mortality between the groups.
CONCLUSIONS
GDHT reduced the rate of DCI after subarachnoid hemorrhage with a better functional outcome (GOS=5) 3 months after discharge. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01832389.",2020,"Even after adjustment for confounding parameters, GDHT was found to be superior to standard therapy (hazard ratio, 2.84 [95% CI, 1.18-6.86]; P =0.02).","['108 patients', 'After Aneurysmal Subarachnoid Hemorrhage', 'Patients >18 years of age with an aneurysmal subarachnoid hemorrhage']","['standard therapy or GDHT', 'GDHT', 'goal-directed hemodynamic therapy (GDHT', 'Goal-Directed Therapy']","['rate of DCI after subarachnoid hemorrhage', 'GOS', 'Glasgow Outcome Scale (GOS', 'occurrence of DCI', 'mortality', 'Delayed Ischemia']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}]","[{'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",108.0,0.182296,"Even after adjustment for confounding parameters, GDHT was found to be superior to standard therapy (hazard ratio, 2.84 [95% CI, 1.18-6.86]; P =0.02).","[{'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Anetsberger', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gempt', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Blobner', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Ringel', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Bogdanski', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heim', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schneider', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Yu-Mi', 'Initials': 'YM', 'LastName': 'Ryang', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wostrack', 'Affiliation': 'Department of Neurosurgery (J.G., F.R., B.M., Y.-M.R., M.W.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Ehrhardt', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Jungwirth', 'Affiliation': 'Department of Anesthesiology (A.A., M.B., R.B., M.H., G.S., S.S., J.S., J.M., M.E., B.J.), Klinikum rechts der Isar, Technical University Munich, Germany.'}]",Stroke,['10.1161/STROKEAHA.120.029279']
1117,32648409,"Use of biophysical treatment for the management of mild anxiety, depression and stress: a randomized controlled trial.",,2020,,"['mild anxiety, depression and stress']",['biophysical treatment'],[],"[{'cui': 'C0231401', 'cui_str': 'Mild anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0005553', 'cui_str': 'Biophysics'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0959965,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Foletti', 'Affiliation': 'Clinical Biophysics International Research Group, Lugano, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Baron', 'Affiliation': 'Clinical Biophysics International Research Group, Lugano, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Berchialla', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Francone', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Malandrone', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ostacoli', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Carletto', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Italy.'}]",Journal of biological regulators and homeostatic agents,['10.23812/20-132-L-57']
1118,32646379,90 days impacts of remote ischemic preconditioning on patients undergoing open total aortic arch replacement: a post-hoc analysis of previous trial.,"BACKGROUND
In the previous randomized controlled trial by our research group, we evaluated the effect of remote ischemic preconditioning (RIPC) in 130 patients (65 per arm) on acute kidney injury (AKI) within 7 days of open total aortic arch replacement. Significantly fewer RIPC-treated patients than sham-treated patients developed postoperative AKI, and, epically, RIPC significantly reduced serious AKI (stage II-III). However, the long-term effect of RIPC in patients undergoing open total aortic arch replacement is unclear.
METHODS
This study was a post-hoc analysis. We aimed to assess the roles of RIPC in major adverse kidney events (MAKE), defined as consisting persistent renal dysfunction, renal replacement therapy and mortality, within 90 days after surgery in patients receiving open total aortic arch replacement.
RESULTS
In this 90-day follow-up study, data were available for all study participants. We found that RIPC failed to improve the presence of MAKE within 90 days after surgery (RIPC: 7 of 65[10.8%]) vs sham: 15 of 65[23.1%]; P = 0.061). In those patients who developed AKI after surgery, we found that the rate of MAKE within 90 days after surgery differed between the RIPC group and the sham group (RIPC: 4 of 36[11.2%]; sham: 14 of 48[29.2%]; P = 0.046).
CONCLUSIONS
At 90 days after open total aortic arch replacement, we failed to find a difference between the renoprotective effects of RIPC and sham treatment. The effectiveness or ineffectiveness of RIPC should be further investigated in a large randomized sham-controlled trial.
TRIAL REGISTRATION
This study was approved by the Ethics Committee of Fuwai Hospital (No. 2016-835) and our previous study was registered at clinicaltrials.gov before patient enrollment ( NCT03141385 ; principal investigator: G.W.; date of registration: March 5, 2017).",2020,"Significantly fewer RIPC-treated patients than sham-treated patients developed postoperative AKI, and, epically, RIPC significantly reduced serious AKI (stage II-III).","['130 patients (65 per arm) on acute kidney injury (AKI) within 7\u2009days of open total aortic arch replacement', 'patients undergoing open total aortic arch replacement', 'patients receiving open total aortic arch replacement']","['remote ischemic preconditioning', 'RIPC', 'remote ischemic preconditioning (RIPC']",['postoperative AKI'],"[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3697092', 'cui_str': 'Aortic arch replacement'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]",,0.491524,"Significantly fewer RIPC-treated patients than sham-treated patients developed postoperative AKI, and, epically, RIPC significantly reduced serious AKI (stage II-III).","[{'ForeName': 'Yimeng', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Belishi road 167, Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Guyan', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Belishi road 167, Xicheng District, Beijing, 100037, China. guyanwang2006@163.com.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lijing', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Belishi road 167, Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Congya', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Belishi road 167, Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Xiying', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Belishi road 167, Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Guiyu', 'Initials': 'G', 'LastName': 'Lei', 'Affiliation': 'Department of Anesthesiology, Beijng Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang, Dongcheng District, Beijing, 100730, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01085-9']
1119,32646428,"Daily consumption of one teaspoon of trehalose can help maintain glucose homeostasis: a double-blind, randomized controlled trial conducted in healthy volunteers.","BACKGROUND
Trehalose is a natural disaccharide that is widely distributed. A previous study has shown that daily consumption of 10 g of trehalose improves glucose tolerance in individuals with signs of metabolic syndrome. In the present study, we determined whether a lower dose (3.3 g/day) of trehalose improves glucose tolerance in healthy Japanese volunteers.
METHODS
This was a randomized, double-blind, placebo-controlled study of healthy Japanese participants (n = 50). Each consumed 3.3 g of trehalose (n = 25) or sucrose (n = 25) daily for 78 days. Their body compositions were assessed following 0, 4, 8, and 12 weeks; and serum biochemical parameters were assayed and oral 75-g glucose tolerance tests were performed at baseline and after 12 weeks.
RESULTS
There were similar changes in body composition and serum biochemistry consistent with established seasonal variations in both groups, but there were no differences in any of these parameters between the two groups. However, whereas after 12 weeks of sucrose consumption, the plasma glucose concentration 2 h after a 75-g glucose load was significantly higher than the fasting concentration, after 12 weeks of trehalose consumption the fasting and 2-h plasma glucose concentrations were similar. Furthermore, an analysis of the participants with relatively high postprandial blood glucose showed that the plasma glucose concentration 2 h after a 75-g glucose load was significantly lower in the trehalose group than in the sucrose group.
CONCLUSIONS
Our findings suggest that trehalose helps lower postprandial blood glucose in healthy humans with higher postprandial glucose levels within the normal range, and may therefore contribute to the prevention of pathologies that are predisposed to by postprandial hyperglycemia,, even if the daily intake of trehalose is only 3.3 g, an amount that is easily incorporated into a meal.
TRIAL REGISTRATION
UMIN, UMIN000033536 . Registered 27 July 2018.",2020,"There were similar changes in body composition and serum biochemistry consistent with established seasonal variations in both groups, but there were no differences in any of these parameters between the two groups.","['healthy Japanese participants (n\u2009=\u200950', 'healthy humans', 'healthy volunteers', 'individuals with signs of metabolic syndrome', 'healthy Japanese volunteers']","['trehalose', 'trehalose (n\u2009=\u200925) or sucrose', 'placebo']","['glucose tolerance', 'postprandial blood glucose', 'serum biochemical parameters', 'plasma glucose concentration', 'fasting and 2-h plasma glucose concentrations', 'body composition and serum biochemistry']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0040815', 'cui_str': 'Trehalose'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}]",,0.132141,"There were similar changes in body composition and serum biochemistry consistent with established seasonal variations in both groups, but there were no differences in any of these parameters between the two groups.","[{'ForeName': 'Chiyo', 'Initials': 'C', 'LastName': 'Yoshizane', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan. chiyo.yoshizane@hb.nagase.co.jp.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Mizote', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Arai', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Norie', 'Initials': 'N', 'LastName': 'Arai', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Rieko', 'Initials': 'R', 'LastName': 'Ogawa', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Endo', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Mitsuzumi', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}, {'ForeName': 'Shimpei', 'Initials': 'S', 'LastName': 'Ushio', 'Affiliation': 'Hayashibara Co. Ltd., 675 Fujisaki, Naka-ku, Okayama, 702-8006, Japan.'}]",Nutrition journal,['10.1186/s12937-020-00586-0']
1120,32475294,Sixth-year follow-up of the effects of recreational activities found to eliminate the symptoms of social phobia and shyness.,"BACKGROUND
The lack of 6-year follow-up studies that test the effect of recreational activities in the recovery of social phobia and shyness symptoms is the reason to conduct this study.
AIM
The purpose is to follow the effect of the 12-week recreational activity program found to eliminate social phobia and shyness symptoms after the completion of university studies in its sixth year.
METHODS
At the end of the 12-week recreational activity program that treats the symptoms of social phobia and shyness in university prep school students, 83 students who participated in the posttest both from intervention and control groups were invited to the study. In the sixth-year follow-up study, a total of 51 voluntary students - 32 from the intervention group and 19 from the control group - were administered the Liebowitz Social Anxiety Scale, the Shyness Scale and the Coopersmith Self-Esteem Inventory.
RESULTS
When the pretests and the sixth-year scores are compared, it is seen that it still has an improving effect on social phobia and shyness; when the posttests and the sixth-year tests are compared, no difference is seen regarding social phobia whereas it is seen that recovery still continues regarding the symptoms of shyness, and a decrease is seen in self-esteem.
DISCUSSION
While the improving effect of recreational activities on shyness and social phobia symptoms still continues, their effect on self-esteem decreases.
CONCLUSION
It is suggested that recreational activities should be included in the programs at universities regarding personal and professional development, and the reasons for the decrease in self-esteem scores should be determined through more detailed studies.",2020,"When the pretests and the sixth-year scores are compared, it is seen that it still has an improving effect on social phobia and shyness; when the posttests and the sixth-year tests are compared, no difference is seen regarding social phobia whereas it is seen that recovery still continues regarding the symptoms of shyness, and a decrease is seen in self-esteem.
","['university prep school students, 83 students who participated in the posttest both from intervention and control groups were invited to the study']","['recreational activities', 'recreational activity program']","['Liebowitz Social Anxiety Scale', 'social phobia and shyness symptoms']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0037020', 'cui_str': 'Shyness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",83.0,0.0164186,"When the pretests and the sixth-year scores are compared, it is seen that it still has an improving effect on social phobia and shyness; when the posttests and the sixth-year tests are compared, no difference is seen regarding social phobia whereas it is seen that recovery still continues regarding the symptoms of shyness, and a decrease is seen in self-esteem.
","[{'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Karagün', 'Affiliation': 'Faculty of Sports Science, Department of Recreation, Kocaeli University, Kocaeli, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Yildiz', 'Affiliation': 'Faculty of Medicine, Department of Psychiatry, Kocaeli University, Kocaeli, Turkey.'}, {'ForeName': 'Çiğdem', 'Initials': 'Ç', 'LastName': 'Çağlayan', 'Affiliation': 'Faculty of Medicine, Department of Public Health, Kocaeli University, Kocaeli, Turkey.'}, {'ForeName': 'Zekiye', 'Initials': 'Z', 'LastName': 'Başaran', 'Affiliation': 'Faculty of Sports Sciences, Kocaeli University, Kocaeli, Turkey.'}]",The International journal of social psychiatry,['10.1177/0020764020924702']
1121,32476465,Comparison of Anticoagulants for Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: A Pilot Study.,"BACKGROUND
Direct-acting oral anticoagulants are indicated for the treatment of nonvalvular atrial fibrillation, but their use in patients after undergoing cardiac surgery is poorly defined despite a high prevalence of postoperative atrial fibrillation in this population.
METHODS
Patients diagnosed with postoperative atrial fibrillation were prospectively randomized to warfarin or apixaban. Safety, efficacy, and economic outcomes were evaluated until their 4- to 6-week postoperative appointment.
RESULTS
While this pilot study was not powered to determine a difference in safety or efficacy, adverse event rates were similar to the published literature. It was noted that a patient's course of therapy when utilizing apixaban was significantly less costly than warfarin when including medication, bridging, and laboratory expenses.
CONCLUSION
Apixaban and warfarin both appeared to be safe and effective for anticoagulation throughout the duration of this pilot study in treating postoperative atrial fibrillation after coronary artery bypass grafting. Apixaban was associated with significantly less expense when bridging and monitoring costs were included in addition to medication expense.",2020,"RESULTS
While this pilot study was not powered to determine a difference in safety or efficacy","['Patients diagnosed with postoperative atrial fibrillation', 'patients after undergoing cardiac surgery']","['warfarin or apixaban', 'Coronary Artery Bypass Grafting', 'Anticoagulants', 'warfarin', 'Apixaban and warfarin', 'Apixaban']","['adverse event rates', 'safety or efficacy', 'Safety, efficacy, and economic outcomes', 'Postoperative Atrial Fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",,0.119252,"RESULTS
While this pilot study was not powered to determine a difference in safety or efficacy","[{'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Chapin', 'Affiliation': 'Pharmacy Services, 23506Sanford Health, Fargo, ND, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Leedahl', 'Affiliation': 'Pharmacy Services, 23506Sanford Health, Fargo, ND, USA.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Brown', 'Affiliation': '12281University of North Dakota School of Medicine and Health Sciences, Grand Forks, ND, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Pasek', 'Affiliation': '12281University of North Dakota School of Medicine and Health Sciences, Grand Forks, ND, USA.'}, {'ForeName': 'Mitchell G', 'Initials': 'MG', 'LastName': 'Sand', 'Affiliation': '12281University of North Dakota School of Medicine and Health Sciences, Grand Forks, ND, USA.'}, {'ForeName': 'Maari L', 'Initials': 'ML', 'LastName': 'Loy', 'Affiliation': 'Pharmacy Services, 275292Essentia Health, Fargo, ND, USA.'}, {'ForeName': 'Cornelius M', 'Initials': 'CM', 'LastName': 'Dyke', 'Affiliation': '12281University of North Dakota School of Medicine and Health Sciences, Grand Forks, ND, USA.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420929483']
1122,32479794,"Tepotinib plus gefitinib in patients with EGFR-mutant non-small-cell lung cancer with MET overexpression or MET amplification and acquired resistance to previous EGFR inhibitor (INSIGHT study): an open-label, phase 1b/2, multicentre, randomised trial.","BACKGROUND
We evaluated the efficacy and safety of tepotinib, a potent and highly selective oral MET inhibitor, plus gefitinib in patients with epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) with MET overexpression (immunohistochemistry [IHC]2+ or IHC3+) or MET amplification having acquired resistance to EGFR inhibition.
METHODS
In this open-label, phase 1b/2, multicentre, randomised trial (the INSIGHT study), we enrolled adult patients (≥18 years) with advanced or metastatic NSCLC, and Eastern Cooperative Oncology Group performance status of 0 or 1, from academic medical centres and community clinics in six Asian countries. In phase 1b, patients received oral tepotinib 300 mg or 500 mg plus gefitinib 250 mg once daily. In phase 2, patients with EGFR-mutant, T790M-negative NSCLC MET overexpression or MET amplification were randomly assigned (initially in a 1:1 ratio and then 2:1 following a protocol amendment) to tepotinib plus gefitinib at the recommended phase 2 dose or to standard platinum doublet chemotherapy. Randomisation was done centrally via an interactive voice-response system. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival (OS) and safety. Subgroup analyses were preplanned in patients with high MET overexpression (IHC3+) or MET amplification (mean gene copy number ≥5 or MET to centromere of chromosome 7 ratio ≥2). Efficacy and patient characteristics were assessed on an intention-to-treat basis and safety was assessed for all patients who received at least one dose of study medication. Low recruitment led to early termination of phase 2, so all analyses are considered to be exploratory. This study is registered with ClinicalTrials.gov, NCT01982955, and the European Union Drug Regulating Authorities Clinical Trials Database, Eudra-CT 2016-001604-28.
FINDINGS
From Dec 23, 2013, to May 25, 2017, 18 patients were enrolled in phase 1b (n=6 in the 300 mg tepotinib group; n=12 in the 500 mg tepotinib group) and 55 patients in phase 2 (n=31 in the tepotinib plus gefitinib group; n=24 in the chemotherapy group). No dose-limiting toxicities were observed in phase 1b, so tepotinib 500 mg was used as the recommended phase 2 dose. In phase 2, survival outcomes were similar between groups: median PFS was 4·9 months in the tepotinib plus gefitinib group (90% CI 3·9-6·9) versus 4·4 months in the chemotherapy group (90% CI 4·2-6·8; hazard ratio [HR] 0·67, 90% CI 0·35-1·28). Median OS was 17·3 months in the tepotinib plus gefitinib group (12·1-37·3) versus 18·7 months in the chemotherapy group (15·9-20·7; HR 0·69, 0·34-1·41). PFS and OS were longer with tepotinib plus gefitinib than with chemotherapy in patients with high (IHC3+) MET overexpression (n=34; median PFS 8·3 months [4·1-16·6] vs 4·4 months [4·1-6·8]; HR 0·35, 0·17-0·74; median OS 37·3 months [90% CI 24·2-37·3] vs 17·9 months [12·0-20·7]; HR 0·33, 0·14-0·76) or MET amplification (n=19; median PFS 16·6 months [8·3-not estimable] vs 4·2 months [1·4-7·0]; HR 0·13, 0·04-0·43; median OS 37·3 months [90% CI not estimable] vs 13·1 months [3·25-not estimable]; HR 0·08, 0·01-0·51). The most frequent treatment-related grade 3 or worse adverse events were increased amylase (5 [16%] of 31 patients) and lipase (4 [13%]) concentrations in the tepotinib plus gefitinib group and anaemia (7 [30%] of 23 patients) and decreased neutrophil count (3 [13%]) in the chemotherapy group.
INTERPRETATION
Despite early study termination, in a preplanned subgroup analysis, our findings suggest improved anti activity for tepotinib plus gefitinib compared with standard chemotherapy in patients with EGFR-mutant NSCLC and MET amplification, warranting further exploration.
FUNDING
Merck KGaA.",2020,"In phase 2, survival outcomes were similar between groups: median PFS was 4·9 months in the tepotinib plus gefitinib group (90% CI 3·9-6·9) versus 4·4 months in the chemotherapy group (90% CI 4·2-6·8; hazard ratio","['From Dec 23, 2013, to May 25, 2017, 18 patients were enrolled in phase 1b (n=6 in the 300 mg tepotinib group', 'patients with epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) with MET overexpression (immunohistochemistry [IHC]2+ or IHC3+) or MET amplification having acquired resistance to EGFR inhibition', 'patients with EGFR-mutant non-small-cell lung cancer with MET overexpression or MET amplification and acquired resistance to previous EGFR inhibitor (INSIGHT study', 'n=12 in the 500 mg tepotinib group) and 55 patients in phase 2 (n=31 in the tepotinib plus gefitinib group', 'patients with EGFR-mutant, T790M-negative NSCLC MET overexpression or MET amplification', 'n=24 in the chemotherapy group', 'enrolled adult patients (≥18 years) with advanced or metastatic NSCLC, and Eastern Cooperative Oncology Group performance status of 0 or 1, from academic medical centres and community clinics in six Asian countries']","['Tepotinib plus gefitinib', 'standard chemotherapy', 'oral tepotinib 300 mg or 500 mg plus gefitinib', 'tepotinib plus gefitinib at the recommended phase 2 dose or to standard platinum doublet chemotherapy']","['investigator-assessed progression-free survival (PFS', 'anti activity', 'Median OS', 'neutrophil count', 'median PFS', 'anaemia', 'intention-to-treat basis and safety', 'adverse events', 'PFS and OS', 'No dose-limiting toxicities', 'overall survival (OS) and safety', 'survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0587907', 'cui_str': 'Community clinic'}, {'cui': 'C0454705', 'cui_str': 'Asian country'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",18.0,0.166598,"In phase 2, survival outcomes were similar between groups: median PFS was 4·9 months in the tepotinib plus gefitinib group (90% CI 3·9-6·9) versus 4·4 months in the chemotherapy group (90% CI 4·2-6·8; hazard ratio","[{'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China. Electronic address: syylwu@live.cn.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Province Cancer Hospital, Changchun, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Chest Hospital, Shanghai, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Ross Andrew', 'Initials': 'RA', 'LastName': 'Soo', 'Affiliation': 'National University Cancer Institute, Singapore.'}, {'ForeName': 'Sang-We', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Sir Run Run Shaw Hospital, Zhejiang Medical University, Zhejiang, China.'}, {'ForeName': 'Yuh-Min', 'Initials': 'YM', 'LastName': 'Chen', 'Affiliation': 'Department of Chest Medicine, Taipei Veteran General Hospital and School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Chih-Feng', 'Initials': 'CF', 'LastName': 'Chian', 'Affiliation': 'Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Affiliated Hospital of Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Daniel Shao Weng', 'Initials': 'DSW', 'LastName': 'Tan', 'Affiliation': 'National Cancer Center, Singapore.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Bruns', 'Affiliation': 'Biostatistics, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Straub', 'Affiliation': 'Translational Medicine, Department of Clinical Biomarkers and Companion Diagnostics, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Johne', 'Affiliation': 'Global Clinical Development, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Scheele', 'Affiliation': 'Global Clinical Development, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'James Chih-Hsin', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30154-5']
1123,32304283,Efficacy and safety of metformin and sitagliptin-based dual and triple therapy in elderly Chinese patients with type 2 diabetes: Subgroup analysis of STRATEGY study.,"AIMS/INTRODUCTION
To assess the efficacy and safety of metformin/sitagliptin-based dual/triple therapy in elderly Chinese patients with type 2 diabetes mellitus.
MATERIALS AND METHODS
This subgroup analysis included individuals aged ≥65 years from the STRATEGY study, a two-stage study in which type 2 diabetes mellitus patients with unsatisfactory glycemic control on metformin were first treated with the dual combination of metformin and sitagliptin for 16 weeks (n = 681), and then, if glycemic control had not been achieved, were treated with a third add-on oral antihyperglycemic drug for another 24 weeks (n = 291). The efficacy end-point was change in glycated hemoglobin (HbA1c) in each stage, and the safety end-point was adverse events with a focus on hypoglycemia.
RESULTS
At week 16, the change in HbA1c was -0.81% from baseline, and the percentages of patients who achieved HbA1c targets of <7% and <7.5% were 44.9 and 67.2%, respectively. After 24 weeks, a further average HbA1c reduction of -0.60% was observed with specific reductions of -0.70% with glimepiride, -0.63% with gliclazide, -0.51% with repaglinide and -0.45% with acarbose. The proportions of patients who achieved HbA1c targets of <7% and <7.5% were 65.4 and 81.3%, respectively, over the entire study. The rates of drug-related adverse events and hypoglycemia were, respectively, 4.1 and 4.3% in the dual therapy stage, and 5.2% and 7.1% in the triple therapy stage, without occurrence of severe hypoglycemia.
CONCLUSIONS
In elderly Chinese type 2 diabetes mellitus patients, metformin/sitagliptin-based dual and triple oral therapy can provide clinically meaningful glycemic control and is generally well tolerated with a low incidence of hypoglycemia.",2020,"The rates of drug-related adverse events and hypoglycemia were, respectively, 4.1 and 4.3% in the dual therapy stage, and 5.2% and 7.1% in the triple therapy stage, without occurrence of severe hypoglycemia.
","['elderly Chinese type\xa02 diabetes mellitus patients', 'individuals aged ≥65\xa0years from the STRATEGY study, a two-stage study in which type\xa02 diabetes mellitus patients with unsatisfactory glycemic control on metformin were first treated with the dual combination of', 'elderly Chinese patients with type\xa02 diabetes mellitus', 'elderly Chinese patients with type\xa02 diabetes']","['gliclazide', 'repaglinide', 'metformin and sitagliptin-based dual and triple therapy', 'acarbose', 'metformin and sitagliptin', 'metformin/sitagliptin-based dual and triple oral therapy', 'glimepiride', 'metformin/sitagliptin-based dual/triple therapy']","['Efficacy and safety', 'efficacy and safety', 'rates of drug-related adverse events and hypoglycemia', 'change in HbA1c', 'glycated hemoglobin (HbA1c']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439856', 'cui_str': 'Unsatisfactory'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C1952576', 'cui_str': 'metformin and sitagliptin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0406655,"The rates of drug-related adverse events and hypoglycemia were, respectively, 4.1 and 4.3% in the dual therapy stage, and 5.2% and 7.1% in the triple therapy stage, without occurrence of severe hypoglycemia.
","[{'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Engel', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Longyi', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yao', 'Affiliation': 'Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Guojuan', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'MSD China Holding Co., Ltd., Shanghai, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'MSD China Holding Co., Ltd., Shanghai, China.'}, {'ForeName': 'Ruya', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'MSD China Holding Co., Ltd., Shanghai, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'MSD R&D (China) Co., Ltd., Beijing, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Weng', 'Affiliation': 'Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Qiuhe', 'Initials': 'Q', 'LastName': 'Ji', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}]",Journal of diabetes investigation,['10.1111/jdi.13277']
1124,31810730,A personalized behavioral intervention implementing mHealth technologies for older adults: A pilot feasibility study.,"Sedentary behavior has been associated with adverse health outcomes such as disturbed sleep in older adults. We conducted a single-group pretest and posttest study to evaluate the feasibility of a personalized behavioral intervention program using mobile health technology in improving physical activity and sleep in older adults. The four-week intervention included: personalized physical activity training, real-time physical activity self-monitoring, interactive prompts and feedback with a smartwatch, phone consultation with an exercise trainer and research team members, and weekly financial incentives for achieving weekly physical activity goals. Eight cognitively intact older adults were recruited and completed the study. Findings suggested that the intervention was feasible in this sample of older adults and provided favorable changes in levels of physical activity during the intervention and at post-intervention. Future studies will include a fully powered trial to evaluate the efficacy of this intervention in sedentary older adults.",2020,Findings suggested that the intervention was feasible in this sample of older adults and provided favorable changes in levels of physical activity during the intervention and at post-intervention.,"['Eight cognitively intact older adults', 'sedentary older adults', 'older adults']","['personalized behavioral intervention implementing mHealth technologies', 'personalized behavioral intervention program using mobile health technology', 'personalized physical activity training, real-time physical activity self-monitoring, interactive prompts and feedback with a smartwatch, phone consultation with an exercise trainer and research team members, and weekly financial incentives for achieving weekly physical activity goals']","['levels of physical activity', 'physical activity and sleep']","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",,0.0171957,Findings suggested that the intervention was feasible in this sample of older adults and provided favorable changes in levels of physical activity during the intervention and at post-intervention.,"[{'ForeName': 'Junxin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Johns Hopkins School of Nursing, 525 North Wolfe Street, Baltimore, MD 21205, United States. Electronic address: jli248@jhu.edu.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Hodgson', 'Affiliation': 'University of Pennsylvania School of Nursing, United States.'}, {'ForeName': 'M Melanie', 'Initials': 'MM', 'LastName': 'Lyons', 'Affiliation': 'University of Pennsylvania School of Nursing, United States; The Ohio State University College of Medicine, United States.'}, {'ForeName': 'Ker-Cheng', 'Initials': 'KC', 'LastName': 'Chen', 'Affiliation': 'University of Pennsylvania School of Medicine, United States.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'University of Minnesota School of Nursing, United States.'}, {'ForeName': 'Nalaka S', 'Initials': 'NS', 'LastName': 'Gooneratne', 'Affiliation': 'University of Pennsylvania School of Medicine, United States.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2019.11.011']
1125,28715932,The Association of Socioeconomic Conditions and Readiness to Learn New Ways of Performing Daily Activities in Older Adults With Functional Difficulties.,"Behavioral interventions for older adults can reduce difficulties in performing daily activities, hospitalizations, and mortality risk. The success of behavior change interventions, however, can be affected by a participant's readiness to adopt changes. This study evaluates whether socioeconomic conditions, particularly financial strain affording food, are associated with readiness to change. We conducted a cross-sectional, descriptive study of baseline data from disabled older adults ( N = 147) participating in an intervention to reduce physical disability. Readiness to change score was rated at the start of the intervention by interventionists as either pre-action (precontemplation = 1, contemplation = 2, preparation = 3) or action (=4). Participants reporting high financial strain affording food were more likely to have high readiness at the start of intervention; the association of this specific socioeconomic condition with readiness may be an important consideration in implementing interventions to reduce disability.",2019,Participants reporting high financial strain affording food were more likely to have high readiness at the start of intervention; the association of this specific socioeconomic condition with readiness may be an important consideration in implementing interventions to reduce disability.,"['disabled older adults ( N = 147) participating in an intervention to reduce physical disability', 'older adults', 'Older Adults With Functional Difficulties']",['Behavioral interventions'],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]",[],147.0,0.0165898,Participants reporting high financial strain affording food were more likely to have high readiness at the start of intervention; the association of this specific socioeconomic condition with readiness may be an important consideration in implementing interventions to reduce disability.,"[{'ForeName': 'Kelly T', 'Initials': 'KT', 'LastName': 'Gleason', 'Affiliation': '1 School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': '1 School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Szanton', 'Affiliation': '1 School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464817721110']
1126,32586077,Postactivation potentiation effects of Back Squat and Barbell Hip Thrust exercise on vertical jump and sprinting performance.,"BACKGROUND
This study aimed to determine and compare the post-activation potentiation (PAP) effects of the Back Squat (SQ-PAP) and Hip Thrust (HT-PAP) exercises in terms of vertical jump height (VJ), 20-yard dash and 40-yard dash time in physically active university students. Considering the Force-vector theory, it was hypothesized that HT-PAP would induce greater potentiation for 40-yard dash than SQ-PAP whereas SQ-PAP would induce greater potentiation for 20-yard dash and VJ than HT-PAP.
METHODS
Seventeen kinesiology and exercise science students (8 male and 9 female) who resistance train at least 3 times/week (age, 21.71±1.49 years; body mass, 75.58±11.89 kg; height, 173.98±11.88 cm and training experience 5.47±2.00 years) joined this study. They performed three experimental sessions namely; baseline (BL), SQ-PAP loading session and HT-PAP loading session with 48 hours interval with a randomized open crossover study design. BL session was also accepted as control and familiarization session. SQ-PAP and HT-PAP exercises were performed roughly at 90% of 1 Repetition maximum (1 RM) of the subjects with three repetitions. Subjects were tested for vertical jump height (VJ), 20-yard dash and 40-yard dash time before and 8 minutes after each PAP loading exercise.
RESULTS
Statistical analysis revealed that the potentiation effects of SQ-PAP and HT-PAP exercises on VJ height, 20-yard and 40-yard dash were similar that none of the loading exercises with 8 min rest interval had any increasing or detrimental performance effect on VJ (P=0.923), 20-yard dash (P=0.133) as well 40-yard dash time (P=0.570).
CONCLUSIONS
These findings demonstrate that none of the loading protocols with above mentioned exercises have any detrimental or improving effects on VJ height, 20-yard dash and 40-yard dash time for physically active university students who joined this study. Although no acute potentiation effect has been found, this study also shows that SQ-PAP, HT-PAP exercises can be used interchangeably and safely to avoid training monotony during longer training periods for chronic adaptations.",2020,"These findings demonstrate that none of the loading protocols with above mentioned exercises have any detrimental or improving effects on VJ height, 20-yard dash and 40-yard dash time for physically active university students who joined this study.","['physically active university students', 'Seventeen kinesiology and exercise science students (8 male and 9 female) who resistance train at least 3 times/week (age, 21.71± 1.49 years; body mass, 75.58± 11.89 kg; height,173.98± 11.88 cm and training experience 5.47±2.00 years) joined this study']","['Back Squat and Barbell Hip Thrust exercise', 'Back Squat (SQ-PAP) and Hip Thrust (HT-PAP) exercises']","['vertical jump height (VJ), 20-yard dash and 40-yard dash time', 'vertical jump and sprinting performance', 'VJ height, 20-yard dash and 40-yard dash time', 'VJ height, 20-yard and 40-yard dash', 'SQ-PAP and HT-PAP exercises', 'vertical jump height (VJ), 20-yard dash and 40- yard dash time']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0456698', 'cui_str': 'times/week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439205', 'cui_str': 'yd'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0202927,"These findings demonstrate that none of the loading protocols with above mentioned exercises have any detrimental or improving effects on VJ height, 20-yard dash and 40-yard dash time for physically active university students who joined this study.","[{'ForeName': 'Ozan', 'Initials': 'O', 'LastName': 'Atalağ', 'Affiliation': 'Department of Kinesiology and Exercise Sciences, University of Hawaii, Hilo, HI, USA - ozan@hawaii.edu.'}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Kurt', 'Affiliation': 'Department of Coaching Education, School of Kirkpinar Physical Education and Sports, Trakya University, Edirne, Turkey.'}, {'ForeName': 'Evelin', 'Initials': 'E', 'LastName': 'Solyomvari', 'Affiliation': 'Department of Kinesiology and Exercise Sciences, University of Hawaii, Hilo, HI, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Sands', 'Affiliation': 'Department of Kinesiology and Exercise Sciences, University of Hawaii, Hilo, HI, USA.'}, {'ForeName': 'Ciera', 'Initials': 'C', 'LastName': 'Cline', 'Affiliation': 'Department of Kinesiology and Exercise Sciences, University of Hawaii, Hilo, HI, USA.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10888-0']
1127,32586078,Repetitions in reserve vs. maximum effort resistance training programs in youth female athletes.,"BACKGROUND
This study aimed to analyze and compare the effects of two different resistance training programs.
METHODS
Fourteen under-17 youth female basketball players were randomly assigned to repetitions in reserve (RIR, N.=7) or maximum effort (RM, N.=7) resistance training programs. The programs consisted of 3-4 sets of 4 exercises x 7-10 repetitions with 2 min of passive recovery between sets and exercises, twice a week for a period of 8 weeks. The RIR group was instructed to perform the exercises with 3 repetitions remaining (rate of perceived exertion [RPE] =7). The physical assessment included jumping, agility, and sprinting tests. Moreover, the maximum strength (one maximum-repetition [1-RM]) and muscle power output at 60% 1RM were assessed for back-squat and bench-press exercises.
RESULTS
The within-group analysis showed improvements in all tests for both groups (RIR=1.3-43.9%; RM=1.3-17.2%). Between-group analyses showed a significant interaction effect (group x time) on 1-RM bench-press (F=8.07, P<0.05, η2p=0.40), favoring RIR group.
CONCLUSIONS
This study reports for the first time that the use of RIR-based RPE resistance training protocol promotes improvements in high-intensity actions (sprinting, jumping, and cutting), muscle power output, and maximum strength, particularly in youth athletes. Considering the advantages of non-failure training, RIR training may be a suitable in-season training strategy. However, more studies are needed to confirm whether the training-induced benefits of this novel training strategy are significantly better as compared to other approaches.",2020,"Between-group analyses showed a substantially better performance of the RER group in the countermovement jump (ES = 0.80), V-cut (ES = 0.72), T-test (ES = 1.39), and in the averagepower bench-press (ES = 0.60), and 1RM bench-press (ES = 0.60, p < 0.05).","['Fourteen under-17 youth female basketball players', 'youth athletes', 'youth female athletes']","['maximum effort (RM, n = 7) resistance training programs', 'RIR-based RPE resistance training protocol', 'RIR training']","['physical assessment included jumping, agility, and sprinting tests', '1-RM bench-press', 'high-intensity actions (sprinting, jumping, and cutting), muscle power output, and maximum strength', 'maximum strength (one maximum-repetition [1-RM]) and muscle power output']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",7.0,0.0492495,"Between-group analyses showed a substantially better performance of the RER group in the countermovement jump (ES = 0.80), V-cut (ES = 0.72), T-test (ES = 1.39), and in the averagepower bench-press (ES = 0.60), and 1RM bench-press (ES = 0.60, p < 0.05).","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Arede', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), University of Trás-os-Montes and Alto Douro, Vila Real, Portugal - jorge_arede@hotmail.com.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Vaz', 'Affiliation': 'University of Trás-os-Montes and Alto Douro, Vila Real, Portugal.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gonzalo-Skok', 'Affiliation': 'Faculty of Health Sciences, University of San Jorge, Zaragoza, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Balsalobre-Fernandéz', 'Affiliation': 'Department of Physical Education, Sport and Human Movement, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Varela-Olalla', 'Affiliation': 'Department of Physical Education, Sport and Human Movement, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Madruga-Parera', 'Affiliation': 'University School of Health and Sport (EUSES), University of Girona, Girona, Spain.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Leite', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), University of Trás-os-Montes and Alto Douro, Vila Real, Portugal.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10907-1']
1128,32589939,Combination of Rigid and Nonrigid Fixation Versus Nonrigid Fixation for Bilateral Mandibular Fractures: A Multicenter Randomized Controlled Trial.,"PURPOSE
We aimed to compare complication rates and functional outcomes in patients with bilateral mandibular fractures treated with different degrees of internal fixation rigidity.
PATIENTS AND METHODS
This international, multicenter randomized controlled trial included adults with bilateral mandibular fractures located at either the angle and body, angle and symphysis, or body and symphysis. Patients were treated with either a combination of rigid fixation for the anterior fracture and nonrigid fixation for the posterior fracture (mixed fixation) or nonrigid fixation for both fractures. The primary outcome was complications within 6 weeks after surgery. Secondary outcomes were complications within 3 months, Helkimo dysfunction index, and mandibular mobility at 6 weeks and 3 months after surgery.
RESULTS
Of the 315 patients enrolled, 158 were randomized to the mixed fixation group and 157 to the nonrigid fixation group. The overall complication rate at 6 weeks in the intention-to-treat population was 9.6% (95% confidence interval [CI], 5.3% to 15.6%) in the mixed fixation group and 7.8% (95% CI, 4.0% to 13.5%) in the nonrigid fixation group. With an unadjusted odds ratio of 1.25 (95% CI, 0.51 to 3.17), there were no statistically significant differences in complication rates between the 2 groups (P = .591). A multivariable model for complication risk at 6 weeks found no significant differences between treatment groups, but patients with moderate or severe displacement had a higher complication rate than those with no or minimal displacement (adjusted odds ratio, 4.58; 95% CI, 1.16 to 18.06; P = .030). There were no significant between-group differences in complication rates at 3 months. Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received.
CONCLUSIONS
A combination of rigid and nonrigid fixation in patients with bilateral mandibular fracture has similar complication rates and functional outcomes to nonrigid fixation for both fractures.",2020,"Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received.
","['patients with bilateral mandibular fractures treated with different degrees of internal fixation rigidity', 'adults with bilateral mandibular fractures located at either the angle and body, angle and symphysis, or body and symphysis', 'patients with bilateral mandibular fracture', '315 patients enrolled', 'Bilateral Mandibular Fractures']","['rigid fixation for the anterior fracture and nonrigid fixation for the posterior fracture (mixed fixation) or nonrigid fixation', 'nonrigid fixation group', 'rigid and nonrigid fixation', 'Rigid and Nonrigid Fixation Versus Nonrigid Fixation']","['complication rates', 'Helkimo dysfunction index and mandibular mobility index', 'complication risk', 'overall complication rate', 'complications within 6\xa0weeks after surgery', 'complication rate', 'complications within 3\xa0months, Helkimo dysfunction index, and mandibular mobility', 'complication rates and functional outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0224520', 'cui_str': 'Symphysis structure'}]","[{'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",315.0,0.151617,"Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received.
","[{'ForeName': 'Vivesh', 'Initials': 'V', 'LastName': 'Rughubar', 'Affiliation': 'Head, Clinical Unit, Maxillofacial and Oral Surgery, Department of Oral and Maxillofacial Surgery, King Edward VIII Hospital, Durban, South Africa.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Vares', 'Affiliation': 'Professor, Head, and Chair of Surgical Dentistry & Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.'}, {'ForeName': 'Priyadeshni', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Dentist, Department of Oral and Maxillofacial Surgery, King Edward VIII Hospital, Durban, South Africa.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Filipsky', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Creanga', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Emergency County Hospital, Constanta, Romania.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Iqbal', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Hospital Sungai Buloh, Selangor, Malaysia.'}, {'ForeName': 'Moustafa', 'Initials': 'M', 'LastName': 'Alkhalil', 'Affiliation': 'Head, Department Oral and Maxillofacial Surgery and CranioMaxilloFacial Surgery/Head and Neck Surgery Department, Hamad Medical, Doha, Qatar.'}, {'ForeName': 'Eeva', 'Initials': 'E', 'LastName': 'Kormi', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Päijät-Häme Central Hospital, Päijät-Häme Joint Authority of Health and Wellbeing, Lahti, Finland (currently), and, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Hanken', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Asklepios Hospital North, Faculty of Medicine, Semmelweis University Campus Hamburg, Hamburg, Germany (currently), and Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alvaro Rivero', 'Initials': 'AR', 'LastName': 'Calle', 'Affiliation': 'Consultant, Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, University Hospital 12 Octubre de Madrid, Madrid, Spain.'}, {'ForeName': 'Wenko', 'Initials': 'W', 'LastName': 'Smolka', 'Affiliation': 'Senior Surgeon, Department of Oral & Maxillofacial Surgery, Ludwig Maximilian University, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Turner', 'Affiliation': 'Chief of Oral and Maxillofacial Surgery, Division of Oral and Maxillofacial Surgery, Mount Sinai Hospital, New York City, NY.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Csáki', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Ministry of Defense Health Centre, Budapest, Hungary.'}, {'ForeName': 'Gregorio', 'Initials': 'G', 'LastName': 'Sánchez-Aniceto', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, University Hospital 12 Octubre de Madrid, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pérez', 'Affiliation': 'Associate Professor and Program Director, Department of Oral and Maxillofacial Surgery, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Carl-Peter', 'Initials': 'CP', 'LastName': 'Cornelius', 'Affiliation': 'Associate Professor, Ludwig-Maximilians University, Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie, Munich, Germany.'}, {'ForeName': 'Belal', 'Initials': 'B', 'LastName': 'Alani', 'Affiliation': 'Specialist, CranioMaxilloFacial Surgery/Head and Neck Surgery Department, Hamad Medical, Doha, Qatar.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vlad', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Emergency County Hospital, Constanta, Romania.'}, {'ForeName': 'Risto', 'Initials': 'R', 'LastName': 'Kontio', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Ellis', 'Affiliation': 'Professor and Chair of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, The University of Texas Health Science Center at San Antonio, San Antonio, TX. Electronic address: ellise3@uthscsa.edu.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.012']
1129,32597287,Immediate effects of plantar vibration stimuli during static upright posture following total hip arthroplasty in females.,"PURPOSE
Proprioceptive function of the lower limbs deteriorates in patients following total hip arthroplasty. Patients show poor balance and rely more on visual information than proprioceptive information. Plantar vibration stimuli can mechanically enhance somatosensory input from the plantar cutaneous mechanoreceptors, thereby improving static balance. Plantar vibration stimuli may improve static balance in patients after total hip arthroplasty. This is the first study to investigate whether plantar vibration stimuli affects static balance during the early phase following total hip arthroplasty.
MATERIALS AND METHODS
In this cross-over design study, 16 female patients (aged 65.1 ± 11.0 years) received plantar vibration stimuli for 2 minutes or the sham interventions after total hip arthroplasty in a randomized order on different days. The foot centre of pressure was measured for the total path length, mediolateral path length, and anteroposterior path length directions before and immediately after the interventions in the static standing position both with eyes open and closed. Patients were instructed to minimize body sway when standing.
RESULTS
A significant increase was observed in the centre of pressure parameters in the eyes closed condition than in the eyes open condition. The centre of pressure parameters for the eyes closed condition was significantly decreased after vibration interventions than that before intervention.
CONCLUSIONS
This study supports the view that plantar vibration stimuli can change static balance in patients in the early phase after total hip arthroplasty temporarily by up-weighting sensory information. These stimuli may serve as a treatment option for influencing balance following total hip arthroplasty.",2020,The centre of pressure parameters for the eyes closed condition was significantly decreased after vibration interventions than that before intervention.,"['total hip arthroplasty in females', '16 female patients (aged 65.1\u2009±\u200911.0\u2009years) received', 'patients after total hip arthroplasty', 'patients following total hip arthroplasty', 'patients in the early phase after total hip arthroplasty temporarily by up-weighting sensory information', 'total hip arthroplasty']","['plantar vibration stimuli during static upright posture', 'plantar vibration stimuli for 2\u2009minutes or the sham interventions after total hip arthroplasty', 'Plantar vibration stimuli', 'plantar vibration stimuli']","['centre of pressure parameters', 'static balance', 'total path length, mediolateral path length, and anteroposterior path length directions']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}]","[{'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0439755', 'cui_str': 'Directions'}]",16.0,0.0128333,The centre of pressure parameters for the eyes closed condition was significantly decreased after vibration interventions than that before intervention.,"[{'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Oku', 'Affiliation': 'Nara Medical University Graduate School, Kashihara, Nara, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Kawahara', 'Affiliation': 'Division of Rehabilitation, Hanna Central Hospital, Ikoma, Nara, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Sugioka', 'Affiliation': 'Division of Rehabilitation, Hanna Central Hospital, Ikoma, Nara, Japan.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Orthopaedic Surgery, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Hoshiba', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Tokorozawa, Saitama, Japan.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Hirose', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Tokorozawa, Saitama, Japan.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Kumai', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Tokorozawa, Saitama, Japan.'}]",Somatosensory & motor research,['10.1080/08990220.2020.1784129']
1130,32593779,Aspirin for the prevention of placenta-mediated complications in pregnant women with chronic hypertension.,"Chronic hypertension affects 1-5% of women of childbearing age. During pregnancy, chronic hypertension is associated with an increased risk of vascular disease such as superimposed preeclampsia (PE), intrauterine growth retardation (IUGR), placental abruption, and preterm delivery. These serious and frequent pathologies, specific to pregnancy, carry a particularly high risk of maternal complications (HELLP syndrome, eclampsia, maternal death) and perinatal complications (perinatal death, neurological disorders). To date, there is no curative treatment of vascular complications of chronic hypertension during pregnancy. The only effective treatment, once the complications are established, is usually stopping the pregnancy and delivering the placenta. Some recommendations suggest the use of low dose aspirin in the prevention of these complications. Although the efficacy of low-dose aspirin is assumed in patients with previous preeclampsia, few studies have evaluated its efficacy in patients with chronic hypertension. Controlled prospective studies using very low doses of aspirin (less than 100 mg) and started after 15 weeks of gestation do not seem conclusive. The objective of this work is first to detail the complications of chronic hypertension during pregnancy, then to analyze the studies which evaluated the interest of low dose aspirin in prevention of the placental vascular complications of the pregnancy in patients with chronic hypertension. We also propose an update on the European and North American national recommendations for the prevention of preeclampsia by low dose aspirin in the high-risk population of patients with chronic hypertension. Finally we present the CHASAP (Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy) trial (NCT04356326), a multicentric prospective randomized double-blind superiority trial, which will compare, in pregnant women with chronic hypertension, the efficacy of low dose aspirin (150 mg/day) with a placebo, in the prevention of maternal-fetal morbidity and mortality (preeclampsia, placental abruption, IUGR, perinatal death, maternal death, and preterm delivery).",2020,"a multicentric prospective randomized double-blind superiority trial, which will compare, in pregnant women with chronic hypertension, the efficacy of low dose aspirin (150 mg/day) with a placebo, in the prevention of maternal-fetal morbidity and mortality (preeclampsia, placental abruption, IUGR, perinatal death, maternal death, and preterm delivery).","['pregnant women with chronic hypertension', 'patients with previous preeclampsia', '150\u2009mg/day) with a', 'patients with chronic hypertension']","['aspirin', 'placebo']","['Chronic hypertension', 'maternal-fetal morbidity and mortality (preeclampsia, placental abruption, IUGR, perinatal death, maternal death, and preterm delivery']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0000832', 'cui_str': 'Placental abruption'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]",,0.0912185,"a multicentric prospective randomized double-blind superiority trial, which will compare, in pregnant women with chronic hypertension, the efficacy of low dose aspirin (150 mg/day) with a placebo, in the prevention of maternal-fetal morbidity and mortality (preeclampsia, placental abruption, IUGR, perinatal death, maternal death, and preterm delivery).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lecarpentier', 'Affiliation': 'University Paris Est Créteil and CHI Créteil, Créteil, France; Department of Obstetrics Gynecology and Reproductive Medicine, University Paris Est Créteil, Centre Hospitalier Inter-Communal de Créteil, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Haddad', 'Affiliation': 'University Paris Est Créteil and CHI Créteil, Créteil, France; Department of Obstetrics Gynecology and Reproductive Medicine, University Paris Est Créteil, Centre Hospitalier Inter-Communal de Créteil, France. Electronic address: Bassam.Haddad@chicreteil.fr.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101845']
1131,31834239,"Effect of Intravenous Aminocaproid Acid on Blood Loss and Transfusion Requirements After Bilateral Varus Rotational Osteotomy: A Double-blind, Placebo-controlled Randomized Trial.","BACKGROUND
ε-Aminocaproic acid (EACA) is an antifibrinolytic agent that has been shown to decrease blood loss and transfusion requirements in several populations undergoing various surgical procedures. However, the efficacy of EACA has not been assessed in pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies. The purpose of this study was to assess the efficacy of intravenous EACA in reducing calculated intraoperative blood loss and transfusions in this population.
METHODS
Patients aged 18 years or younger were eligible. Patients were randomized to receive EACA or placebo (saline), and randomization was stratified based on sex and whether or not additional soft tissue or osseous procedures were performed. On the basis of retrospective data, the calculated sample size was 12 patients per arm to detect a difference of 250-mL blood loss. The primary outcome was calculated intraoperative blood loss. Secondary outcomes included transfusion requirements, 24-hour drain output, length of stay, and incidence of complications.
RESULTS
The mean age of patients in this study was 8 years (SD: 2.4 y). There were no differences in age, sex, height, weight, type of anesthesia, operative time, and associated procedures between the EACA and placebo groups (P>0.05). Preoperative hematocrit was lower in the EACA group (37.1 vs. 40.0, P=0.04). Calculated intraoperative blood loss was 536 mL in the EACA group and 628 mL in the placebo group (P=0.45). Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68). Total 24-hour drain output was 72.5 mL in the EACA group and 103.3 mL in the placebo group (P=0.37). Length of stay was similar between both groups, and there were no drug or placebo-related complications in either group.
CONCLUSIONS
There was no difference in blood loss or transfusion requirements associated with EACA compared with placebo; however, this study is underpowered to detect smaller differences in blood loss. Additional studies with larger sample sizes are needed to confirm these findings and further elucidate the indications for antifibrinolytic agents in pediatric patients.
LEVEL OF EVIDENCE
Level I.",2019,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"['several populations undergoing various surgical procedures', 'pediatric patients', 'After Bilateral Varus Rotational Osteotomy', 'Patients aged 18 years or younger were eligible', 'pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies']","['Placebo', 'ε-Aminocaproic acid (EACA', 'EACA', 'EACA or placebo (saline', 'Intravenous Aminocaproid Acid', 'placebo']","['Length of stay', 'blood loss or transfusion requirements', 'Total 24-hour drain output', 'Preoperative hematocrit', '250-mL blood loss', 'Blood Loss and Transfusion Requirements', 'blood loss and transfusion requirements', 'Transfusions', 'calculated intraoperative blood loss', 'transfusion requirements, 24-hour drain output, length of stay, and incidence of complications', 'blood loss', 'Calculated intraoperative blood loss']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0407433', 'cui_str': 'Rotational osteotomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000608', 'cui_str': '6-Aminocaproic Acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.423115,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"[{'ForeName': 'Ishaan', 'Initials': 'I', 'LastName': 'Swarup', 'Affiliation': ""Division of Pediatric Orthopaedic Surgery, University of California, San Francisco, UCSF Benioff Children's Hospital Oakland, Oakland, CA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Healthcare Research Institute.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Edmonds', 'Affiliation': 'Division of Anesthesiology.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dodwell', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scher', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001480']
1132,32602616,Safety and Efficacy of Budesonide for Liver Transplant Immune Suppression: Results of a Pilot Phase 2a Trial.,"Despite adverse effects like hyperglycemia, new-onset diabetes after transplant (NODAT), and infectious complications, corticosteroid use remains an important part of liver transplantation (LT) immune suppression. Budesonide, a synthetic corticosteroid, undergoes extensive first-pass hepatic metabolism with only 10% systemic bioavailability, providing an opportunity for an improved toxicity-therapeutic ratio. Although effective in the treatment of autoimmune hepatitis, the effects of budesonide for LT immune suppression are unknown. We conducted a single-center phase 2a trial to study the safety and efficacy of budesonide immunosuppressive therapy. From July 2017 to November 2018, 20 patients undergoing a first LT received budesonide tapering doses (from 9 to 3 mg) for 12 weeks. Patients were compared with matched control patients who received prednisone from the same time period. Additionally, both groups received calcineurin inhibitors and mycophenolate mofetil. Outcome measures at week 24 included rates of biopsy-proven acute cellular rejection (ACR), NODAT (hemoglobin A1c >6.4%), and infectious complications. In the budesonide arm, 1 patient developed ACR at week 5 and was removed from the study. Another patient stopped the study drug at week 8 due to persistent nausea. Rates of ACR were similar between the budesonide and control groups (5% versus 5%, P = 1.00). Three patients in the control group developed NODAT versus none in the budesonide group (15% versus 0%; P = 0.23). There were 6 infections in the control group compared with none in the budesonide group (30% versus 0; P = 0.02). These pilot data suggest that budesonide has the potential to be a safe and effective alternative to prednisone for LT immune suppression while reducing steroid-induced infections and NODAT. Randomized controlled trials are required to validate these findings.",2020,"Rates of ACR were similar between budesonide and control groups (5% vs 5%, p=1.00).","['Liver Transplant Immune Suppression', 'From July 2017 to November 2018, twenty subjects undergoing first LT received']","['prednisone', 'Budesonide', 'budesonide immunosuppressive therapy', 'budesonide', 'calcineurin inhibitors and mycophenolate']","['rates of biopsy proven Acute Cellular Rejection (ACR), NODAT (Glycated Hemoglobin > 6.4) and infectious complications', 'Safety and Efficacy', 'safety and efficacy', 'toxicity-therapeutic ratio', 'Rates of ACR']","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}]","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0877453', 'cui_str': 'Acute cellular rejection'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0678793', 'cui_str': 'Therapeutic Index'}]",20.0,0.0575914,"Rates of ACR were similar between budesonide and control groups (5% vs 5%, p=1.00).","[{'ForeName': 'Khurram', 'Initials': 'K', 'LastName': 'Bari', 'Affiliation': 'Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Shimul A', 'Initials': 'SA', 'LastName': 'Shah', 'Affiliation': 'Division of, Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Tiffany E', 'Initials': 'TE', 'LastName': 'Kaiser', 'Affiliation': 'Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Cohen', 'Affiliation': 'Transplant Surgery, Department of Surgery, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Anwar', 'Affiliation': 'Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kleesattel', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Sherman', 'Affiliation': 'Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25837']
1133,32487236,"A randomized, crossover comparison of ketamine and electroconvulsive therapy for treatment of major depressive episodes: a Canadian biomarker integration network in depression (CAN-BIND) study protocol.","BACKGROUND
Recent evidence underscores the utility of rapid-acting antidepressant interventions, such as ketamine, in alleviating symptoms of major depressive episodes (MDE). However, to date, there have been limited head-to-head comparisons of intravenous (IV) ketamine infusions with other antidepressant treatment strategies in large randomized trials. This study protocol describes an ongoing multi-centre, prospective, randomized, crossover, non-inferiority trial comparing acute treatment of individuals meeting diagnostic criteria for a major depressive episode (MDE) with ketamine and electroconvulsive therapy (ECT) on efficacy, speed of therapeutic effects, side effects, and health care resource utilization. A secondary aim is to compare a 6-month maintenance strategy for ketamine responders to standard of care ECT maintenance. Finally, through the measurement of clinical, cognitive, neuroimaging, and molecular markers we aim to establish predictors and moderators of treatment response as well as treatment-elicited effects on these outcomes.
METHODS
Across four participating Canadian institutions, 240 patients with major depressive disorder or bipolar disorder experiencing a MDE are randomized (1:1) to a course of ECT or racemic IV ketamine (0.5 mg/kg) administered 3 times/week for 3 or 4 weeks. Non-responders (< 50% improvement in Montgomery-Åsberg Depression Rating Scale [MADRS] scores) crossover to receive the alternate treatment. Responders during the randomization or crossover phases then enter the 6-month maintenance phase during which time they receive clinical assessments at identical intervals regardless of treatment arm. ECT maintenance follows standard of care while ketamine maintenance involves: weekly infusions for 1 month, then bi-weekly infusions for 2 months, and finally monthly infusions for 3 months (returning to bi-weekly in case of relapse). The primary outcome measure is change in MADRS scores after randomized treatment as assessed by raters blind to treatment modality.
DISCUSSION
This multi-centre study will help identify molecular, imaging, and clinical characteristics of patients with treatment-resistant and/or severe MDEs who would benefit most from either type of therapeutic strategy. In addition to informing clinical practice and influencing health care delivery, this trial will add to the robust platform and database of CAN-BIND studies for future research and biomarker discovery.
TRIAL REGISTRATION
ClinicalTrials.gov identifier NCT03674671. Registered September 17, 2018.",2020,Non-responders (< 50% improvement in Montgomery-Åsberg Depression Rating Scale [MADRS] scores),"['individuals meeting diagnostic criteria for a major depressive episode (MDE) with', 'major depressive episodes', 'patients with treatment-resistant and/or severe MDEs who would benefit most from either type of therapeutic strategy', '240 patients with major depressive disorder or bipolar disorder experiencing a MDE']","['ketamine and electroconvulsive therapy', 'ketamine and electroconvulsive therapy (ECT', 'ketamine', 'ECT or racemic IV ketamine']","['Montgomery-Åsberg Depression Rating Scale [MADRS] scores', 'change in MADRS scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0047006', 'cui_str': 'Methylenedioxyethylamphetamine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",240.0,0.221186,Non-responders (< 50% improvement in Montgomery-Åsberg Depression Rating Scale [MADRS] scores),"[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Phillips', 'Affiliation': ""The Royal's Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada. Jennifer.Phillips@theroyal.ca.""}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Jaworska', 'Affiliation': ""The Royal's Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kamler', 'Affiliation': ""The Royal's Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada.""}, {'ForeName': 'Venkat', 'Initials': 'V', 'LastName': 'Bhat', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Blier', 'Affiliation': 'Montfort Hospital, 713 Montreal Rd, Ottawa, ON, K1K 0T2, Canada.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Foster', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hassel', 'Affiliation': 'Department of Psychiatry and Mathison Centre for Mental Health Research and Education, Cumming School of Medicine, University of Calgary, 3330 Hospital Dr NW, Calgary, AB, T2N 4N1, Canada.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Ho', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McMurray', 'Affiliation': 'Department of Psychiatry, University of Ottawa, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada.'}, {'ForeName': 'Roumen', 'Initials': 'R', 'LastName': 'Milev', 'Affiliation': ""Department of Psychiatry, Queen's University, Providence Care Hospital, 752 King Street West, Postal Bag 603, Kingston, ON, K7L 7X3, Canada.""}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Moazamigoudarzi', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Franca M', 'Initials': 'FM', 'LastName': 'Placenza', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Richard-Devantoy', 'Affiliation': 'McGill University, 845 Rue Sherbrooke O, Montréal, QC, H3A 0G4, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Rotzinger', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Turecki', 'Affiliation': 'McGill University, 845 Rue Sherbrooke O, Montréal, QC, H3A 0G4, Canada.'}, {'ForeName': 'Gustavo H', 'Initials': 'GH', 'LastName': 'Vazquez', 'Affiliation': ""Department of Psychiatry, Queen's University, Providence Care Hospital, 752 King Street West, Postal Bag 603, Kingston, ON, K7L 7X3, Canada.""}, {'ForeName': 'Sidney H', 'Initials': 'SH', 'LastName': 'Kennedy', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blier', 'Affiliation': ""The Royal's Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC psychiatry,['10.1186/s12888-020-02672-3']
1134,32590151,Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial.,"BACKGROUND
Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation to treat patients with symptomatic drug-refractory atrial fibrillation (AF).
OBJECTIVE
The purpose of this study was to assess the safety and efficacy of PVI using the cryoballoon catheter to treat patients with persistent AF.
METHODS
STOP Persistent AF (ClinicalTrials.gov Identifier: NCT03012841) was a prospective, multicenter, single-arm, Food and Drug Administration-regulated trial designed to evaluate the safety and efficacy of PVI-only cryoballoon ablation for drug-refractory persistent AF (continuous episodes <6 months). The primary efficacy endpoint was 12-month freedom from ≥30 seconds of AF, atrial flutter (AFL), or atrial tachycardia (AT) after a 90-day blanking period. The prespecified performance goals were set at >40% and <13% for the primary efficacy and safety endpoints, respectively. Secondary endpoints assessed quality of life using the AFEQT (Atrial Fibrillation Effect on Quality of Life) and SF (Short Form)-12 questionnaires.
RESULTS
Of 186 total enrollments, 165 subjects (70% male; age 65 ± 9 years; left atrial diameter 4.2 ± 0.6 cm; body mass index 31 ± 6) were treated at 25 sites in the United States, Canada, and Japan. Total procedural, left atrial dwell, and fluoroscopy times were 121 ± 46 minutes, 102 ± 41 minutes, and 19 ± 16 minutes, respectively. At 12 months, the primary efficacy endpoint was 54.8% (95% confidence [CI] 46.7%-62.1%) freedom from AF, AFL, or AT. There was 1 primary safety event, translating to a rate of 0.6% (95% CI 0.1%-4.4%). AFEQT and SF-12 assessments demonstrated significant improvements from baseline to 12 months postablation (P <.001).
CONCLUSION
The STOP Persistent AF trial demonstrated cryoballoon ablation to be safe and effective in treating patients with drug-refractory persistent AF characterized by continuous AF episodes <6 months.",2020,"AFEQT and SF-12 assessments demonstrated significant improvements from baseline to 12 months post ablation (P<0.001).
","['Persistent Atrial Fibrillation', 'patients with symptomatic drug-refractory atrial fibrillation (AF', 'Of 186 total enrollments, 165 subjects (70% male, 65±9 years, left atrial diameter 4.2±0.6 cm, body mass index 31±6) were treated at 25 sites in the United States, Canada, and Japan']","['Cryoballoon Ablation of Pulmonary Veins', 'Pulmonary vein isolation (PVI', 'PVI-only cryoballoon ablation for drug-refractory persistent AF', 'PVI']","['Total procedure, left atrial dwell, and fluoroscopy times', 'safety and efficacy', 'quality of life using the AFEQT and SF-12 questionnaires', '12-month freedom from ≥30 sec of AF, atrial flutter (AFL), or atrial tachycardia (AT']","[{'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}]",,0.0320406,"AFEQT and SF-12 assessments demonstrated significant improvements from baseline to 12 months post ablation (P<0.001).
","[{'ForeName': 'Wilber W', 'Initials': 'WW', 'LastName': 'Su', 'Affiliation': 'Banner University Medical Center Phoenix, Phoenix, Arizona.'}, {'ForeName': 'Vivek Y', 'Initials': 'VY', 'LastName': 'Reddy', 'Affiliation': 'Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Kabir', 'Initials': 'K', 'LastName': 'Bhasin', 'Affiliation': 'Northwell Health-Lenox Hill Heart and Lung, New York, New York.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Champagne', 'Affiliation': 'Institut Universitaire de Cardiologie et du Pneumologie de Quebec, Quebec, Canada.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Sangrigoli', 'Affiliation': 'Doylestown Cardiology Associates, Doylestown, Pennsylvania.'}, {'ForeName': 'Kendra M', 'Initials': 'KM', 'LastName': 'Braegelmann', 'Affiliation': 'Medtronic, Inc., Minneapolis, Minnesota.'}, {'ForeName': 'Fred J', 'Initials': 'FJ', 'LastName': 'Kueffer', 'Affiliation': 'Medtronic, Inc., Minneapolis, Minnesota.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': 'Royal Jubilee Hospital, Victoria, Canada.'}, {'ForeName': 'Sanjaya K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': ""Saint Luke's Health System, Kansas City, Missouri.""}, {'ForeName': 'Teiichi', 'Initials': 'T', 'LastName': 'Yamane', 'Affiliation': 'Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Calkins', 'Affiliation': 'Johns Hopkins Medical Institutions, Baltimore, Maryland. Electronic address: hcalkins@jhmi.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Heart rhythm,['10.1016/j.hrthm.2020.06.020']
1135,32593287,High-flow nasal cannula improves clinical efficacy of airway management in patients undergoing awake craniotomy.,"BACKGROUND
Awake craniotomy requires specific sedation procedure in an awake patient who should be able to cooperate during the intraoperative neurological assessment. Currently, limited number of literatures on the application of high-flow nasal cannula (HFNC) in the anesthetic management for awake craniotomy has been reported. Hence, we carried out a prospective study to assess the safety and efficacy of humidified high-flow nasal cannula (HFNC) airway management in the patients undergoing awake craniotomy.
METHODS
Sixty-five patients who underwent awake craniotomy were randomly assigned to use HFNC with oxygen flow rate at 40 L/min or 60 L/min, or nasopharynx airway (NPA) device in the anesthetic management. Data regarding airway management, intraoperative blood gas analysis, intracranial pressure, gastric antral volume, and adverse events were collected and analyzed.
RESULTS
Patients using HFNC with oxygen flow rate at 40 or 60 L/min presented less airway obstruction and injuries. Patients with HFNC 60 L/min maintained longer awake time than the patients with NPA. While the intraoperative PaO 2 and SPO 2 were not significantly different between the HFNC and NPA groups, HFNC patients achieved higher PaO 2 /FiO 2 than patients with NPA. There were no differences in Brain Relaxation Score and gastric antral volume among the three groups as well as before and after operation in any of the three groups.
CONCLUSION
HFNC was safe and effective for the patients during awake craniotomy.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, CHiCTR1800016621 . Date of Registration: 12 June 2018.",2020,"There were no differences in Brain Relaxation Score and gastric antral volume among the three groups as well as before and after operation in any of the three groups.
","['Sixty-five patients who underwent awake craniotomy', 'patients undergoing awake craniotomy']","['humidified high-flow nasal cannula (HFNC) airway management', 'HFNC with oxygen flow rate at 40\u2009L/min or 60\u2009L/min, or nasopharynx airway (NPA) device', 'HFNC', 'High-flow nasal cannula']","['Brain Relaxation Score and gastric antral volume', 'safety and efficacy', 'intraoperative blood gas analysis, intracranial pressure, gastric antral volume, and adverse events', 'oxygen flow rate', 'airway obstruction and injuries']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001883', 'cui_str': 'Respiratory obstruction'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",65.0,0.0784692,"There were no differences in Brain Relaxation Score and gastric antral volume among the three groups as well as before and after operation in any of the three groups.
","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yi', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, No.12 Wulumuqi Zhong Road, Shanghai, 200040, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Shanghai Jiahui International Hospital, Shanghai, 200000, China.'}, {'ForeName': 'Zhoujing', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, No.12 Wulumuqi Zhong Road, Shanghai, 200040, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, No.12 Wulumuqi Zhong Road, Shanghai, 200040, China.'}, {'ForeName': 'Xiaobing', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, No.12 Wulumuqi Zhong Road, Shanghai, 200040, China.'}, {'ForeName': 'Huahua', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, No.12 Wulumuqi Zhong Road, Shanghai, 200040, China. ghhmzk@sina.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01073-z']
1136,32600327,Experimental pain and fatigue induced by excessive chewing.,"BACKGROUND
The study was aiming to optimize excessive gum chewing as an experimental model to induce jaw muscle pain and fatigue similar to those in painful TMDs with durations that would allow immediate investigations of jaw-motor function. Further, if any sex differences would be detected in the expression of pain.
METHODS
This randomized, double blinded study included 31 healthy participants of both sexes. A standardized chewing protocol of either 40- or 60-min of chewing was used with a wash-out period of 1 week. Subjective fatigue, pain characteristics and functional measures were assessed. For statistical analyses, Wilcoxon Signed Rank test, Mann-Whitney Rank Sum test and Friedman's ANOVA with Tukey post-hoc test were used.
RESULTS
High subjective fatigue scores that lasted up to 20 min after the end of the trial were significantly induced both in the 40- and 60-min chewing trials (P < 0.001*). Significant but mild pain was induced only in the 60-min trial (P = 0.004*) and only in men (P = 0.04*). Also, the induced pain area was significantly bigger in the 60-min trial (P = 0.009*). However, this increase in pain and pain area did not last to the first 10-min follow-up. There were no significant differences neither between the 40- and 60-min chewing trials, except regarding the pain area (P = 0.008*), nor between the sexes.
CONCLUSION
Taken together, excessive chewing in its current form does not seem to be a proper pain experimental model. The model needs further adjustments in order to mimic TMD-pain especially in women and to prolong the pain duration.",2020,"There were no significant differences neither between the 40- and 60-min chewing trials, except regarding the pain area (P = 0.008*), nor between the sexes.
",['31 healthy participants of both sexes'],[],"['pain and pain area', 'Subjective fatigue, pain characteristics and functional measures', 'subjective fatigue scores', 'induced pain area', 'Experimental pain and fatigue', 'expression of pain', 'pain area', 'mild pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1286315', 'cui_str': 'Characteristic of pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}]",31.0,0.0680313,"There were no significant differences neither between the 40- and 60-min chewing trials, except regarding the pain area (P = 0.008*), nor between the sexes.
","[{'ForeName': 'Samaa', 'Initials': 'S', 'LastName': 'Al Sayegh', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, Box 4046, SE-141 04, Huddinge, Sweden. samaa.al.sayegh@ki.se.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Vasilatou', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, Box 4046, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, Box 4046, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Ceva', 'Initials': 'C', 'LastName': 'Al Barwari', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, Box 4046, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Fredriksson', 'Affiliation': 'Department of Clinical Oral Physiology at the Eastman Institute, Folktandvården Stockholms län AB, SE-113 24, Stockholm, Sweden.'}, {'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Grigoriadis', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, Box 4046, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Christidis', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, Box 4046, SE-141 04, Huddinge, Sweden.'}]",BMC oral health,['10.1186/s12903-020-01161-z']
1137,32603494,Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone.,"OBJECTIVE
Somapacitan is a long-acting, reversible albumin-binding growth hormone (GH) derivative in development. This study aimed to evaluate the safety and efficacy of once-weekly somapacitan versus daily GH over 52 weeks in Japanese patients with adult growth hormone deficiency (AGHD).
DESIGN
Phase 3, multicentre, randomized, parallel-group, open-label, active-controlled trial (NCT03075644).
PATIENTS
Previously GH-treated Japanese patients with AGHD were randomized 3:1 to somapacitan (n = 46) or daily GH (n = 16) for 20 weeks' dose titration and 32 weeks' fixed-dose treatment.
MEASUREMENTS
Primary endpoint was the incidence of adverse events (AEs). Secondary endpoints included change from baseline to week 52 in visceral, subcutaneous and total adipose tissue (VAT, SAT and TAT).
RESULTS
Mean (SD) prescribed doses after titration were 1.780 (1.058) mg/week for somapacitan and 0.197 (0.083) mg/day for daily GH. Rate of AEs per 100 patient-years was similar between arms (somapacitan, 312.7; daily GH, 309.8). Four AEs in the somapacitan arm were serious; none were considered treatment-related. Mean insulin-like growth factor-I standard deviation score (IGF-I SDS) was maintained from baseline in both arms. No significant differences were observed between arms for change from baseline to week 52 in VAT, SAT or TAT (estimated difference, somapacitan - daily GH [95% CI]: -1.74 [-18.13; 14.66], -11.53 [-35.54; 12.48] and - 12.85 [-47.31; 21.62] cm 2 , respectively).
CONCLUSIONS
Treatment in both groups was well tolerated, with no unexpected safety findings. Impact on adipose tissue was similar to somapacitan and daily GH in patients with AGHD. A short visual summary of our work is available at https://bit.ly/3946YNF.",2020,"No significant differences were observed between arms for change from baseline to week 52 in VAT, SAT or TAT (estimated difference, somapacitan - daily GH [95% CI]:","['Patients Previously GH-treated Japanese patients with AGHD', 'Japanese patients with adult growth hormone deficiency (AGHD', 'previously treated adults with growth hormone deficiency', 'patients with AGHD', '21.62']","['once-weekly somapacitan versus daily GH', 'somapacitan or daily growth hormone', 'daily GH', 'somapacitan']","['I standard deviation score (IGF-I SDS', 'VAT, SAT or TAT', 'adipose tissue', 'change from baseline to week\xa052 in visceral, subcutaneous and total adipose tissue (VAT, SAT and TAT', 'safety and efficacy', 'incidence of adverse events (AEs', 'Mean insulin-like growth factor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1720505', 'cui_str': 'Adult growth hormone deficiency'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency'}]","[{'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}]","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0017375', 'cui_str': 'TAT gene'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}]",,0.297851,"No significant differences were observed between arms for change from baseline to week 52 in VAT, SAT or TAT (estimated difference, somapacitan - daily GH [95% CI]:","[{'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Otsuka', 'Affiliation': 'Department of General Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Tahara', 'Affiliation': 'Department of Neurosurgery, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'CMR Development Division, Novo Nordisk Pharma Ltd., Tokyo, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Højby Rasmussen', 'Affiliation': 'Global Development, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Takano', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Kitasato University, Sagamihara, Japan.'}]",Clinical endocrinology,['10.1111/cen.14273']
1138,32604939,"Effects of Manual Therapy on Fatigue, Pain, and Psychological Aspects in Women with Fibromyalgia.","Fibromyalgia is a condition characterised by chronic widespread muscle pain and fatigue, sleep disturbances, cognitive disorders, and mood disturbance. The purpose of this study was to determine the effectiveness of a manual therapy technique performed with moderate digital pressure in women with fibromyalgia ( n = 24). In this randomised, controlled trial, the participants were randomly assigned to the experimental group or placebo group. The experimental group was assisted with manual therapy sessions based on connective tissue massage, whereas the placebo group was ""treated"" with ultrasound sessions performed without conductive gel and with the machine turned off as the placebo. Fatigue severity scale (FSS), visual analogical scale (VAS), Pittsburgh sleep quality index (PSQI), and profile of mood states (POMS-29) were completed before and after the intervention. In the experimental group (manual therapy), significant results were obtained on a VAS scale, referring to the neck pain in patients with fibromyalgia ( p < 0.001). Correlations showed a relationship between fatigue and sleep variables ( R = 0.411; p = 0.046) and pain variables with the POMS anger-hostility subscale ( R = 0.436; p = 0.033). Although the size of the sample could be a limitation, the study concluded that the application of manual therapy in fibromyalgia patients performed with moderate pressure for 15 min on the posterior cervical musculature decreased the perception of pain, muscle fatigue, and the state of tension-anxiety.",2020,"In the experimental group (manual therapy), significant results were obtained on a VAS scale, referring to the neck pain in patients with fibromyalgia ( p < 0.001).","['Women with Fibromyalgia', 'fibromyalgia patients', 'women with fibromyalgia ( n = 24']","['Manual Therapy', 'manual therapy technique', 'placebo group was ""treated"" with ultrasound sessions performed without conductive gel and with the machine turned off as the placebo', 'placebo']","['VAS scale, referring to the neck pain', 'fatigue and sleep variables', 'pain variables with the POMS anger-hostility subscale', 'perception of pain, muscle fatigue, and the state of tension-anxiety', 'Fatigue, Pain, and Psychological Aspects', 'Fatigue severity scale (FSS), visual analogical scale (VAS), Pittsburgh sleep quality index (PSQI), and profile of mood states (POMS-29']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",,0.0398758,"In the experimental group (manual therapy), significant results were obtained on a VAS scale, referring to the neck pain in patients with fibromyalgia ( p < 0.001).","[{'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Nadal-Nicolás', 'Affiliation': 'Faculty of Medicine, Miguel Hernández University of Elche, 03202 Elche, Spain.'}, {'ForeName': 'Jacobo Ángel', 'Initials': 'JÁ', 'LastName': 'Rubio-Arias', 'Affiliation': 'Department of Health and Human Performance, Faculty of Physical Activity and Sport Science, Polytechnic University of Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Martínez-Olcina', 'Affiliation': 'Faculty of Health Sciences, University of Alicante, 03690 Alicante, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Reche-García', 'Affiliation': 'Faculty of Nursing, Catholic University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Hernández-García', 'Affiliation': 'Faculty of Health Sciences, University of Alicante, 03690 Alicante, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Martínez-Rodríguez', 'Affiliation': 'Faculty of Sciences, Department of Analytical Chemistry, Nutrition and Food Sciences, University of Alicante, 03690 Alicante, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124611']
1139,32623140,Emotion self-regulation training in major depressive disorder using simultaneous real-time fMRI and EEG neurofeedback.,"Simultaneous real-time fMRI and EEG neurofeedback (rtfMRI-EEG-nf) is an emerging neuromodulation approach, that enables simultaneous volitional regulation of both hemodynamic (BOLD fMRI) and electrophysiological (EEG) brain activities. Here we report the first application of rtfMRI-EEG-nf for emotion self-regulation training in patients with major depressive disorder (MDD). In this proof-of-concept study, MDD patients in the experimental group (n = 16) used rtfMRI-EEG-nf during a happy emotion induction task to simultaneously upregulate two fMRI and two EEG activity measures relevant to MDD. The target measures included BOLD activities of the left amygdala (LA) and left rostral anterior cingulate cortex (rACC), and frontal EEG asymmetries in the alpha band (FAA, [7.5-12.5] Hz) and high-beta band (FBA, [21-30] Hz). MDD patients in the control group (n = 8) were provided with sham feedback signals. An advanced procedure for improved real-time EEG-fMRI artifact correction was implemented. The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC. Average individual FAA changes during the rtfMRI-EEG-nf task positively correlated with depression and anhedonia severities, and negatively correlated with after-vs-before changes in depressed mood ratings. Temporal correlations between the FAA and FBA time courses and the LA BOLD activity were significantly enhanced during the rtfMRI-EEG-nf task. The experimental group participants reported significant mood improvements after the training. Our results suggest that the rtfMRI-EEG-nf may have potential for treatment of MDD.",2020,"The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC.",['patients with major depressive disorder (MDD'],"['Emotion self-regulation training', 'rtfMRI-EEG-nf for emotion self-regulation training']","['BOLD activities of the left amygdala (LA) and left rostral anterior cingulate cortex (rACC), and frontal EEG asymmetries in the alpha band (FAA, [7.5-12.5] Hz) and high-beta band (FBA, [21-30] Hz', 'Average individual FAA changes', 'depression and anhedonia severities', 'LA BOLD activity', 'fMRI connectivity', 'LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0060441', 'cui_str': 'flavone acetic acid'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",,0.014664,"The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC.","[{'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Zotev', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA. Electronic address: vzotev@laureateinstitute.org.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Mayeli', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA; Electrical and Computer Engineering, University of Oklahoma, Tulsa, OK, USA.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Misaki', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Bodurka', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA; Stephenson School of Biomedical Engineering, University of Oklahoma, Norman, OK, USA. Electronic address: jbodurka@laureateinstitute.org.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102331']
1140,32631366,Prompting consumers to make healthier food choices in hospitals: a cluster randomised controlled trial.,"BACKGROUND
Hospitals in the UK offer snacks for sale to patients, staff and visitors. Despite the NHS's health promoting role, and tightening of regulations around which foods can be sold in hospitals, many snacks purchased in this setting are unhealthy. The present project tests the effectiveness of theory-based point of purchase prompts (PPPs; a form of cognitive nudge) designed to make it cognitively easier for consumers to compare available products and choose healthier options.
METHODS
Hospital shops in Scotland (n = 30) were recruited into a cluster randomised controlled trial to test whether a PPP could reduce the average calorie, fat and/or sugar content of purchased snacks. Inclusion criteria stated that eligible sites; sold food; were located in a hospital; and were accessible to staff, patients and visitors. The PPP intervention was a theory-based sign (tailored to the available range in each location) designed to cognitively simplify healthier snack choices by facilitating cross-product comparison. Shops were randomised to display PPPs (intervention; n = 15) or not (control; n = 15) using block randomisation controlling for shop size. Data on all snacks purchased from participating shops were obtained from retailers for a 12-week baseline and 12-week follow-up period. Primary outcomes were the average calorie (kcals), fat(g) and sugar(g) content of snacks purchased each day. Secondary outcomes were the average customer spend per item purchased (£,p) and the total number of snacks purchased daily. Shop staff were not blinded to group assignment but data providers were. Data were analysed using mixed effects multi-level regression models.
RESULTS
Data from > 1 million snack purchases were analysed. Snacks purchased from intervention sites were on average significantly lower in calorie (γ = - 1.84, p < .001) and sugar (γ = - 0.18, p = .030) at follow up relative to baseline but only the reduction in calories was significantly different to control. Average spend per item also reduced significantly in intervention (but not control) sites (γ = - 0.89, p < .001). The intervention had no effect on the fat content of snacks or the number of snacks sold.
CONCLUSIONS
Simple, theory-based point of purchase prompts can produce small but statistically significant reductions in the energy content of snack purchases from hospital shops.
TRIAL REGISTRATION
Retrospectively registered (8/Oct/2018) with ISRCTN (ID: ISRCTN90365793 ).",2020,"Snacks purchased from intervention sites were on average significantly lower in calorie (γ = - 1.84, p < .001) and sugar (γ = - 0.18, p = .030) at follow up relative to baseline but only the reduction in calories was significantly different to control.","['hospitals', 'Hospital shops in Scotland (n\u2009=\u200930']","['display PPPs (intervention; n\u2009=\u200915) or not (control; n\u2009=\u200915) using block randomisation controlling for shop size', 'PPP', 'PPP intervention', 'theory-based point of purchase prompts (PPPs']","['average customer spend per item purchased (£,p) and the total number of snacks purchased daily', 'average calorie (kcals), fat(g) and sugar(g) content of snacks purchased each day', 'fat content of snacks or the number of snacks sold']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019987', 'cui_str': 'Hospital Shop'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041472', 'cui_str': 'Murine typhus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0031106', 'cui_str': 'Aggressive periodontitis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C2742135', 'cui_str': 'SELL protein, human'}]",30.0,0.0862335,"Snacks purchased from intervention sites were on average significantly lower in calorie (γ = - 1.84, p < .001) and sugar (γ = - 0.18, p = .030) at follow up relative to baseline but only the reduction in calories was significantly different to control.","[{'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Allan', 'Affiliation': 'Health Psychology, Institute of Applied Health Sciences, Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK, Scotland. j.allan@abdn.ac.uk.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Powell', 'Affiliation': 'Health Psychology, Institute of Applied Health Sciences, Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK, Scotland.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-00990-z']
1141,32648203,Letter to the Editor Regarding Efficacy and Safety of Diclofenac and Capsaicin Gel in Patients with Acute Back/Neck Pain: A Multicenter Randomized Controlled Study.,,2020,,"['Neck Pain', 'Patients with Acute Back']",['Diclofenac and Capsaicin Gel'],[],"[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]",[],,0.0469216,,"[{'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Schwartz', 'Affiliation': 'Department of Anesthesiology, Mount Sinai Medical Center of Florida, Miami, FL, USA. rubenschwartz@yahoo.com.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Urits', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Viswanath', 'Affiliation': 'Valley Anesthesiology and Pain Consultants, Envision Physician Services, Phoenix, AZ, USA.'}]",Pain and therapy,['10.1007/s40122-020-00181-5']
1142,32648204,Author's Response to: 'Letter to the Editor Regarding Efficacy and Safety of Diclofenac and Capsaicin Gel in Patients with Acute Back/Neck Pain: A Multicenter Randomized Controlled Study'.,,2020,,"['Neck Pain', 'Patients with Acute Back']",['Diclofenac and Capsaicin Gel'],[],"[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]",[],,0.0419255,,"[{'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Weiser', 'Affiliation': 'Consumer Health Care, Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lange', 'Affiliation': 'Consumer Health Care, Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany. robert1.lange@sanofi.com.'}]",Pain and therapy,['10.1007/s40122-020-00182-4']
1143,32649896,Flapless Piezotome Crest Split Achieves Comparable Outcomes to Autologous Onlay Grafts With Significant Less Patient Morbidity and Complications-A Randomized Clinical Study.,"PURPOSE
In the management of the narrow alveolar ridge, the flapless piezotome crest split (FPCS) technique with horizontal distraction was introduced as an alternative to lateral alveolar ridge augmentation using autologous bone block grafting (ABBG). The study purpose was to measure and compare the alveolar crest width and complications between FPCS and ABBG.
MATERIALS AND METHODS
We implemented a nonblinded, randomized clinical trial. The sample included patients requiring lateral alveolar ridge augmentation before implant insertion. The predictor variable was lateral alveolar ridge augmentation performed using ABBG (control group) or FPCS using an ultrasonic surgical device (Piezotome II or Piezotome CUBE; Acteon, Norwich, UK) and specific crest split working tips (test group). The primary outcome variable was the overall coronal crest width achieved after completed healing measured at 6 months using 3-dimensional imaging studies. Other study variables included the postoperative morbidity, staged using the Universal Pain Assessment Scale, complications, and surgery duration. Descriptive and bivariate statistics were computed using SPSS, version 22.0 (IBM Corp, Armonk, NY), and P ≤ .05 was considered to indicate statistical significance.
RESULTS
The sample included 567 patients treated with ABBG (56.1% female; age, 64.1 ± 20.2 years) and 562 treated with FPCS (57.2% female; age, 62.3 ± 18.2 years). The baseline crest width in the control and test groups was 2.1 ± 0.5 mm and 1.9 ± 0.4 mm, respectively. The final crest width achieved with ABBG and FPCS was 5.8 ± 0.8 mm and 6.5 ± 0.7 mm, respectively (P > .05). Statistically significant differences (P < .05) were found between the ABBG and FPCS groups in the postoperative complication rate, morbidity, and operative time, all in favor of FPCS.
CONCLUSIONS
FPCS seems to be a significantly less traumatic alternative to buccal onlay grafting with autologous bone blocks, providing a comparable or better net gain in the alveolar crest width with a significantly shorter operative time and less postoperative morbidity.",2020,"Statistically significant differences (P < .05) were found between the ABBG and FPCS groups in the postoperative complication rate, morbidity, and operative time, all in favor of FPCS.
","['567 patients treated with ABBG (56.1% female; age, 64.1\xa0±\xa020.2\xa0years) and 562 treated with FPCS (57.2% female; age, 62.3\xa0±\xa018.2\xa0years', 'patients requiring lateral alveolar ridge augmentation before implant insertion']","['Flapless Piezotome Crest Split', 'ABBG (control group) or FPCS', 'ultrasonic surgical device (Piezotome II or Piezotome CUBE', 'Autologous Onlay Grafts']","['postoperative morbidity, staged using the Universal Pain Assessment Scale, complications, and surgery duration', 'final crest width achieved with ABBG and FPCS', 'postoperative complication rate, morbidity, and operative time', 'alveolar crest width and complications', 'postoperative morbidity', 'baseline crest width', 'overall coronal crest width achieved after completed healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517642', 'cui_str': '20.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0002387', 'cui_str': 'Augmentation of alveolar ridge'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",567.0,0.067806,"Statistically significant differences (P < .05) were found between the ABBG and FPCS groups in the postoperative complication rate, morbidity, and operative time, all in favor of FPCS.
","[{'ForeName': 'Ziad Tarek', 'Initials': 'ZT', 'LastName': 'Mahmoud', 'Affiliation': 'Lecturer, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Alexandria University, Alexandria, Egypt. Electronic address: drziadtmahmoud@gmail.com.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Wainwright', 'Affiliation': 'Visiting Professor, Faculty of Dentistry, University of Seville, Seville, Spain.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Troedhan', 'Affiliation': 'Visiting Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Alexandria University, Alexandria, Egypt; and Visiting Professor, Institute for Oral and Maxillofacial Surgery and Dentistry, General Hospital ""Krankenhaus Hietzing"" of the City of Vienna, Vienna, Austria.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.06.008']
1144,32649925,"Antipsychotic medication versus psychological intervention versus a combination of both in adolescents with first-episode psychosis (MAPS): a multicentre, three-arm, randomised controlled pilot and feasibility study.","BACKGROUND
Evidence for the effectiveness of treatments in early-onset psychosis is sparse. Current guidance for the treatment of early-onset psychosis is mostly extrapolated from trials in adult populations. The UK National Institute for Health and Care Excellence has recommended evaluation of the clinical effectiveness and cost-effectiveness of antipsychotic drugs versus psychological intervention (cognitive behavioural therapy [CBT] and family intervention) versus the combination of these treatments for early-onset psychosis. The aim of this study was to establish the feasibility of a randomised controlled trial of antipsychotic monotherapy, psychological intervention monotherapy, and antipsychotics plus psychological intervention in adolescents with first-episode psychosis.
METHODS
We did a multicentre pilot and feasibility trial according to a randomised, single-blind, three-arm, controlled design. We recruited participants from seven UK National Health Service Trust sites. Participants were aged 14-18 years; help-seeking; had presented with first-episode psychosis in the past year; were under the care of a psychiatrist; were showing current psychotic symptoms; and met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service. Participants were assigned (1:1:1) to antipsychotics, psychological intervention (CBT with optional family intervention), or antipsychotics plus psychological intervention. Randomisation was via a web-based randomisation system, with permuted blocks of random size, stratified by centre and family contact. CBT incorporated up to 26 sessions over 6 months plus up to four booster sessions, and family intervention incorporated up to six sessions over 6 months. Choice and dose of antipsychotic were at the discretion of the treating consultant psychiatrist. Participants were followed up for a maximum of 12 months. The primary outcome was feasibility (ie, data on trial referral and recruitment, session attendance or medication adherence, retention, and treatment acceptability) and the proposed primary efficacy outcome was total score on the Positive and Negative Syndrome Scale (PANSS) at 6 months. Primary outcomes were analysed by intention to treat. Safety outcomes were reported according to as-treated status, for all patients who had received at least one session of CBT or family intervention, or at least one dose of antipsychotics. The study was prospectively registered with ISRCTN, ISRCTN80567433.
FINDINGS
Of 101 patients referred to the study, 61 patients (mean age 16·3 years [SD 1·3]) were recruited from April 10, 2017, to Oct 31, 2018, 18 of whom were randomly assigned to psychological intervention, 22 to antipsychotics, and 21 to antipsychotics plus psychological intervention. The trial recruitment rate was 68% of our target sample size of 90 participants. The study had a low referral to recruitment ratio (around 2:1), a high rate of retention (51 [84%] participants retained at the 6-month primary endpoint), a high rate of adherence to psychological intervention (defined as six or more sessions of CBT; in 32 [82%] of 39 participants in the monotherapy and combined groups), and a moderate rate of adherence to antipsychotic medication (defined as at least 6 consecutive weeks of exposure to antipsychotics; in 28 [65%] of 43 participants in the monotherapy and combined groups). Mean scores for PANSS total at the 6-month primary endpoint were 68·6 (SD 17·3) for antipsychotic monotherapy (6·2 points lower than at randomisation), 59·8 (13·7) for psychological intervention (13·1 points lower than at randomisation), and 62·0 (15·9) for antipsychotics plus psychological intervention (13·9 points lower than at randomisation). A good clinical response at 6 months (defined as ≥50% improvement in PANSS total score) was achieved in four (22%) of 18 patients receiving antipsychotic monotherapy, five (31%) of 16 receiving psychological intervention, and five (29%) of 17 receiving antipsychotics plus psychological intervention. In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment. No serious adverse events were considered to be related to participation in the trial.
INTERPRETATION
This trial is the first to show that a head-to-head clinical trial comparing psychological intervention, antipsychotics, and their combination is safe in young people with first-episode psychosis. However, the feasibility of a larger trial is unclear because of site-specific recruitment challenges, and amendments to trial design would be needed for an adequately powered clinical and cost-effectiveness trial that provides robust evidence.
FUNDING
National Institute for Health Research.",2020,"In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment.","['101 patients referred to the study, 61 patients (mean age 16·3 years [SD 1·3]) were recruited from April 10, 2017, to Oct 31, 2018, 18 of whom were randomly assigned to psychological intervention, 22 to antipsychotics, and 21 to', 'young people with first-episode psychosis', 'adolescents with first-episode psychosis (MAPS', 'participants from seven UK National Health Service Trust sites', 'adolescents with first-episode psychosis', 'Participants were aged 14-18 years; help-seeking; had presented with first-episode psychosis in the past year; were under the care of a psychiatrist; were showing current psychotic symptoms; and met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service', 'The study had a low referral to recruitment ratio (around 2:1), a high rate of retention (51 [84%] participants retained at the 6-month primary endpoint), a high rate of adherence to psychological intervention (defined as six or more sessions of CBT; in 32 [82%] of 39 participants in the monotherapy and combined groups), and a moderate rate of adherence to antipsychotic medication (defined as at least 6 consecutive weeks of exposure to antipsychotics; in 28 [65%] of 43 participants in the monotherapy and combined groups', 'early-onset psychosis']","['CBT', 'antipsychotics, psychological intervention (CBT with optional family intervention), or antipsychotics plus psychological intervention', 'antipsychotic drugs versus psychological intervention (cognitive behavioural therapy [CBT', 'antipsychotic monotherapy', 'Antipsychotic medication versus psychological intervention', 'antipsychotic monotherapy, psychological intervention monotherapy, and antipsychotics plus psychological intervention', 'antipsychotics plus psychological intervention']","['feasibility (ie, data on trial referral and recruitment, session attendance or medication adherence, retention, and treatment acceptability) and the proposed primary efficacy outcome was total score on the Positive and Negative Syndrome Scale (PANSS', 'serious adverse events', 'PANSS total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0011251', 'cui_str': 'Delusional disorder'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",61.0,0.11201,"In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment.","[{'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Morrison', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, UK; Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, UK. Electronic address: anthony.p.morrison@manchester.ac.uk.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Pyle', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, UK; Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Maughan', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Johns', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Broome', 'Affiliation': ""Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK; Institute for Mental Health and Centre for Human Brain Health, School of Psychology, University of Birmingham, Birmingham, UK; Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, UK; Early Intervention in Psychosis Service, Lancashire and South Cumbria NHS Foundation Trust, Chorley, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fowler', 'Affiliation': 'Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Aberdeen, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'The Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh Medical School, Edinburgh, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shiers', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hollis', 'Affiliation': 'National Institute for Health Research (NIHR) MindTech MedTech Co-operative and NIHR Nottingham Biomedical Research Centre, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'James', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30248-0']
1145,32652969,Effect of vaccine reminder and tracker bracelets on routine childhood immunization coverage and timeliness in urban Pakistan (2017-18): a randomized controlled trial.,"BACKGROUND
Inability to track children's vaccination history coupled with parents' lack of awareness of vaccination due dates compounds the problem of low immunization coverage and timeliness in developing countries. We evaluated the impact of two types of silicone immunization reminder bracelets for children in improving immunization coverage and timeliness of Pentavalent-3 and the Measles-1 vaccines.
METHODS
Children < 3 months were enrolled in either of the 2 intervention groups (Alma Sana Bracelet Group and Star Bracelet Group) or the Control group. Children in the intervention groups were provided the two different bracelets at the time of recruitment. Each time the child visited the immunization center, a hole was perforated in the silicone bracelet to denote vaccine administration. Each child was followed up till administration of Measles-1 vaccine or till 12 months of age (if they did not come to the center for vaccination). Data was analyzed using the intention-to-treat population between groups. The unadjusted and adjusted Risk Ratios (RR) and 95% confidence interval (CI) for Pentavalent-3 and Measles-1 coverage at 12 months of age were estimated through bivariate and multivariate analysis. Time-to-Pentavalent-3 and Measles-1 immunization curves were calculated using the Kaplan-Meier method.
RESULTS
A total of 1,445 children were enrolled in the study between July 19, 2017 and October 10, 2017. Baseline characteristics among the three groups were similar. Up-to-date coverage for the Pentavalent-3 /Measles-1 vaccine at 12 months of age was 84.6%/72.0%, 85.4%/70.5% and 83.0%/68.5% in Alma Sana Bracelet group, Star Bracelet group and Control group respectively but the differences were not statistically significant. In the multivariate analysis, neither the Alma Sana bracelet (adjusted RR = 1.01; 95% CI: 0.96-1.06), (adjusted RR: 1.05; 95% CI: 0.97-1.13) nor the Star bracelet (adjusted RR = 1.01; 95% CI: 0.96-1.06) (adjusted RR: 1.03; 95% CI: 0.95-1.11) was significantly associated with Pentavalent-3 vaccination or Measles-1 vaccination.
CONCLUSION
Although we did not observe any significant impact of the bracelets on improved immunization coverage and timeliness, our findings add to the existing literature on innovative, low cost reminders for health and make several suggestions for enhancing practical implementation of these tools.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03310762 . Retrospectively Registered on October 16, 2017.",2020,"In the multivariate analysis, neither the Alma Sana bracelet (adjusted RR = 1.01; 95% CI: 0.96-1.06), (adjusted RR: 1.05; 95% CI: 0.97-1.13) nor the Star bracelet (adjusted RR = 1.01; 95% CI: 0.96-1.06) (adjusted RR: 1.03; 95% CI: 0.95-1.11) was significantly associated with Pentavalent-3 vaccination or Measles-1 vaccination.
","['Children <\u20093\u2009months were enrolled in either of the 2', 'routine childhood immunization coverage and timeliness in urban Pakistan (2017-18', '1,445 children were enrolled in the study between July 19, 2017 and October 10, 2017']","['intervention groups (Alma Sana Bracelet Group and Star Bracelet Group) or the Control group', 'vaccine reminder and tracker bracelets']","['unadjusted and adjusted Risk Ratios (RR) and 95% confidence interval (CI) for Pentavalent-3 and Measles-1 coverage', 'Star bracelet', 'Time-to-Pentavalent-3 and Measles-1 immunization curves']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0857209', 'cui_str': 'Routine childhood immunization'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0075451', 'cui_str': 'succinyl-trialanine-4-nitroanilide'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",1445.0,0.179193,"In the multivariate analysis, neither the Alma Sana bracelet (adjusted RR = 1.01; 95% CI: 0.96-1.06), (adjusted RR: 1.05; 95% CI: 0.97-1.13) nor the Star bracelet (adjusted RR = 1.01; 95% CI: 0.96-1.06) (adjusted RR: 1.03; 95% CI: 0.95-1.11) was significantly associated with Pentavalent-3 vaccination or Measles-1 vaccination.
","[{'ForeName': 'Danya Arif', 'Initials': 'DA', 'LastName': 'Siddiqi', 'Affiliation': 'IRD Global, 15 Beach Road #02-01, Singapore, 189677, Singapore. danya.arif@ird.global.'}, {'ForeName': 'Rozina Feroz', 'Initials': 'RF', 'LastName': 'Ali', 'Affiliation': 'IRD Pakistan, 4th Floor Woodcraft Building, Korangi Creek, Karachi, 75190, Pakistan.'}, {'ForeName': 'Mehr', 'Initials': 'M', 'LastName': 'Munir', 'Affiliation': 'IRD Pakistan, 4th Floor Woodcraft Building, Korangi Creek, Karachi, 75190, Pakistan.'}, {'ForeName': 'Mubarak Taighoon', 'Initials': 'MT', 'LastName': 'Shah', 'Affiliation': 'IRD Pakistan, 4th Floor Woodcraft Building, Korangi Creek, Karachi, 75190, Pakistan.'}, {'ForeName': 'Aamir Javed', 'Initials': 'AJ', 'LastName': 'Khan', 'Affiliation': 'IRD Global, 15 Beach Road #02-01, Singapore, 189677, Singapore.'}, {'ForeName': 'Subhash', 'Initials': 'S', 'LastName': 'Chandir', 'Affiliation': 'IRD Global, 15 Beach Road #02-01, Singapore, 189677, Singapore.'}]",BMC public health,['10.1186/s12889-020-09088-4']
1146,32660261,Scapular exercise combined with cognitive functional therapy is more effective at reducing chronic neck pain and kinesiophobia than scapular exercise alone: a randomized controlled trial.,"OBJECTIVE
The aim of this study was to compare the effectiveness of scapular exercises alone and combined with cognitive functional therapy in treating patients with chronic neck pain and scapular downward rotation impairment.
DESIGN
Single-blind randomized controlled trial.
SETTING
Outpatient.
SUBJECTS
A total of 72 patients (20-45 years old) with chronic neck pain were studied.
INTERVENTION
Allocation was undertaken into three groups: scapular exercise ( n = 24), scapular exercise with cognitive functional therapy ( n = 24) and control ( n = 24) groups. Each programme lasted three times a week for six weeks.
MAIN OUTCOMES
The primary outcome measure was pain intensity measured by the visual analogue scale scores. The secondary outcome measures included kinesiophobia and muscles activity.
RESULTS
Statistically significant differences in pain intensity were found when multidisciplinary physiotherapy group including a cognitive functional approach was compared with the scapular exercise alone group at six weeks (effect size (95% CI) = -2.56 (-3.32 to -1.80); P = 0.019). Regarding kinesiophobia, a significant between-group difference was observed at six-week (effect size (95% CI) = -2.20 (-2.92 to -1.49); P = 0.005), with the superiority of effect in multidisciplinary physiotherapy group. A significant between-group differences was observed in muscle activity. Also, there were significant between-group differences favouring experimental groups versus control.
CONCLUSION
A group-based multidisciplinary rehabilitation programme including scapular exercise plus cognitive functional therapy was superior to group-based scapular exercise alone for improving pain intensity, kinesiophobia and muscle activation in participants with chronic neck pain.",2020,"A group-based multidisciplinary rehabilitation programme including scapular exercise plus cognitive functional therapy was superior to group-based scapular exercise alone for improving pain intensity, kinesiophobia and muscle activation in participants with chronic neck pain.","['participants with chronic neck pain', 'A total of 72 patients (20-45\u2009years old) with chronic neck pain were studied', 'patients with chronic neck pain and scapular downward rotation impairment', 'Outpatient']","['scapular exercise alone', 'scapular exercise plus cognitive functional therapy was superior to group-based scapular exercise alone', 'Scapular exercise combined with cognitive functional therapy', 'scapular exercises alone and combined with cognitive functional therapy', 'scapular exercise ( n \u2009=\u200924), scapular exercise with cognitive functional therapy']","['pain intensity, kinesiophobia and muscle activation', 'muscle activity', 'pain intensity', 'chronic neck pain and kinesiophobia', 'kinesiophobia and muscles activity', 'pain intensity measured by the visual analogue scale scores']","[{'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205104', 'cui_str': 'Down'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",72.0,0.138117,"A group-based multidisciplinary rehabilitation programme including scapular exercise plus cognitive functional therapy was superior to group-based scapular exercise alone for improving pain intensity, kinesiophobia and muscle activation in participants with chronic neck pain.","[{'ForeName': 'Norollah', 'Initials': 'N', 'LastName': 'Javdaneh', 'Affiliation': 'Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Republic of Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Republic of Iran.'}, {'ForeName': 'Sadredin', 'Initials': 'S', 'LastName': 'Shojaedin', 'Affiliation': 'Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Republic of Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Hadadnezhad', 'Affiliation': 'Department of Biomechanics and Sport injuries, Kharazmi University, Tehran, Republic of Iran.'}]",Clinical rehabilitation,['10.1177/0269215520941910']
1147,32660762,Differences in intermediate vision: monofocal intraocular lenses vs. monofocal extended depth of focus intraocular lenses.,"PURPOSE
The purpose of this study was to analyse whether an extended depth of focus (EDOF) monofocal intraocular lens (IOL) (TECNIS Eyhance™, Johnson&Johnson Surgical Vision, Inc., Santa Ana, CA) provides better intermediate visual acuity (VA) than another monofocal IOL (TECNIS 1-piece™, Johnson&Johnson Surgical Vision, Inc., Santa Ana, CA) from the same platform.
METHODS
Randomised prospective observational study. Patients who required cataract surgery in both eyes were included. Patients in one group were implanted with Tecnis 1-piece IOL and those in the other group with Eyhance EDOF monofocal IOL. One month after surgery in the second eye, we assessed the corrected intermediate VA (66 cm) and obtained defocus curves. We also explored the correlation of: high-order and spherical aberrations with intermediate VA, pupil size with intermediate VA and age with intermediate VA.
RESULTS
We analysed 30 patients (60 eyes), 15 patients in the TECNIS 1-piece group and 15 in the Eyhance group. Both groups achieved a far VA of 0.00 logMAR. In contrast, for intermediate vision, VA was better with the Eyhance EDOF monofocal IOLs (0.16 ± 0.12 LogMAR), the difference being statistically significant (p < 0.001). In addition, binocular intermediate VA was found to be significantly correlated with corneal (6 mm) RMS high-order aberrations (ρ 0.476) and Z 4 0 (ρ 0.483) with the Eyhance IOL.
CONCLUSIONS
The new EDOF monofocal IOL (Eyhance) offers sufficient depth of focus to provide patients with comfortable vision without impairing far vision.",2020,"In addition, binocular intermediate VA was found to be significantly correlated with corneal (6 mm) RMS high-order aberrations (ρ 0.476) and Z 4 0 (ρ 0.483) with the Eyhance IOL.
","['patients with comfortable vision without impairing far vision', '30 patients (60 eyes), 15 patients in the TECNIS 1-piece group and 15 in the Eyhance group', 'Patients who required cataract surgery in both eyes were included']","['extended depth of focus (EDOF) monofocal intraocular lens (IOL) (TECNIS Eyhance™, Johnson&Johnson Surgical Vision, Inc., Santa Ana, CA']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0003243', 'cui_str': 'Antinuclear antibody'}]",[],30.0,0.0222864,"In addition, binocular intermediate VA was found to be significantly correlated with corneal (6 mm) RMS high-order aberrations (ρ 0.476) and Z 4 0 (ρ 0.483) with the Eyhance IOL.
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'de Luis Eguileor', 'Affiliation': 'Hospital Universitario Cruces, Barakaldo, España. Electronic address: beatrizdeluis@gmail.com.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Martínez-Indart', 'Affiliation': 'Biocruces Bizkaia Health Research Institute, Barakaldo, España.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Martínez Alday', 'Affiliation': 'Hospital Universitario Cruces, Barakaldo, España.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sacristán Egüén', 'Affiliation': 'Hospital Universitario Cruces, Barakaldo, España.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cuadros Sánchez', 'Affiliation': 'Hospital Universitario Cruces, Barakaldo, España.'}]",Archivos de la Sociedad Espanola de Oftalmologia,['10.1016/j.oftal.2020.06.009']
1148,32665410,Education Research: Online Alzheimer education for high school and college students: A randomized controlled trial.,"OBJECTIVE
Alzheimer disease (AD) risk factors are present throughout the lifespan. This randomized controlled trial evaluated the effectiveness of various online education strategies concerning AD risk reduction and brain health in younger populations.
METHOD
High school and college students were recruited via social media (Facebook and Instagram) to join AlzU.org, an evidence-based education portal, and were randomized to 1 of 4 courses: highly interactive webinar lessons narrated by actor Seth Rogen (celebrity webinar) or a physician (doctor webinar), minimally interactive video lessons with Seth Rogen (celebrity video), or minimally interactive video lessons (control). Surveys were administered at baseline and postcourse. The primary outcome was change in knowledge of AD risk reduction assessed by pre vs post lesson quiz scores. Secondary outcomes included change in awareness of AD research, hopefulness about AD, interest in pursuing health care, willingness to volunteer, and likelihood of recommending AlzU.org.
RESULT
A total of 721 participants joined. A total of 281 (38.9%) completed the course. Among college students, quiz score improvements were greater in celebrity webinar and celebrity video vs doctor webinar and control. Among high school students, no differences were found in quiz scores. In both groups, celebrity webinar, celebrity video, and doctor webinar resulted in greater improvements in awareness that nutrition and exercise may reduce AD risk vs controls. Among college students, celebrity webinar and celebrity video group participants felt more hopeful about the future of AD and more likely to recommend AlzU.org vs doctor webinar and control participants. Among college students, celebrity webinar, celebrity video, and doctor webinar participants were more willing to volunteer for AD causes and pursue health care careers vs controls.
CONCLUSION
Online education involving a celebrity may be an effective strategy for educating college students about AD risk reduction strategies. Further studies are warranted in high school students.",2020,"Among college students, quiz score improvements were greater in celebrity webinar and celebrity video vs doctor webinar and control.","['721 participants joined', 'high school and college students', 'college students, celebrity webinar, celebrity video, and doctor webinar participants', 'younger populations', 'High school and college students were recruited via social media (Facebook and Instagram) to join AlzU.org, an evidence-based education portal']","['various online education strategies concerning AD risk reduction', 'interactive webinar lessons narrated by actor Seth Rogen (celebrity webinar) or a physician (doctor webinar), minimally interactive video lessons with Seth Rogen (celebrity video), or minimally interactive video lessons (control']","['knowledge of AD risk reduction assessed by pre vs post lesson quiz scores', 'quiz score improvements', 'quiz scores', 'celebrity webinar and celebrity video vs doctor webinar and control', 'change in awareness of AD research, hopefulness about AD, interest in pursuing health care, willingness to volunteer, and likelihood of recommending AlzU.org']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015621', 'cui_str': 'Famous Persons'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205054', 'cui_str': 'Portal'}]","[{'cui': 'C4505477', 'cui_str': 'Online Education'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0015621', 'cui_str': 'Famous Persons'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015621', 'cui_str': 'Famous Persons'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",721.0,0.102402,"Among college students, quiz score improvements were greater in celebrity webinar and celebrity video vs doctor webinar and control.","[{'ForeName': 'Nabeel', 'Initials': 'N', 'LastName': 'Saif', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Kellyann', 'Initials': 'K', 'LastName': 'Niotis', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Moises', 'Initials': 'M', 'LastName': 'Dominguez', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Hodes', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Woodbury', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Amini', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sadek', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Scheyer', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Caesar', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Hollie', 'Initials': 'H', 'LastName': 'Hristov', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Newman', 'Initials': 'N', 'LastName': 'Knowlton', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Isaacson', 'Affiliation': 'From the Department of Neurology (N.S., K.N., M.D., G.S., H.H., M.M., R.S.I.), Weill Cornell Medicine & New York-Presbyterian, New York; Pacific Brain Health Center (J.F.H.), Pacific Neuroscience Institute, Los Angeles, CA; Harvard Medical School (M.W.), Boston, MA; Mailman School of Public Health (Y.A.), Columbia University, New York, NY; School of Law (O.S.) and College of Letters and Science (P.L.), University of California Los Angeles; Loyola School of Medicine (E.C.), Chicago, IL; and Biostatistics (N.K.), Pentara Corporation, Salt Lake City, UT. rii9004@med.cornell.edu.'}]",Neurology,['10.1212/WNL.0000000000009859']
1149,32671481,Efficacy of denosumab co-administered with vitamin D and Ca by baseline vitamin D status.,"INTRODUCTION
In anti-osteoporosis drug trials, vitamin D and calcium (Ca) are common supplements; however, the optimal dose of each is unclear. Using data from the randomized, double-blind, placebo-controlled DIRECT trial, we assessed whether baseline serum 25-hydroxy vitamin D (25[OH]D) level influences the efficacy of denosumab co-administered with vitamin D and Ca.
MATERIALS AND METHODS
In this prespecified sub-analysis, subjects with primary osteoporosis who received denosumab or placebo, plus vitamin D (≥ 400 IU/day) and Ca (≥ 600 mg/day), were classified as 25(OH)D deficient (< 20 ng/mL), insufficient (≥ 20 to < 30 ng/mL), and sufficient (≥ 30 ng/mL). Study endpoints included absolute serum 25(OH)D level at baseline, 12 months, and 24 months; change in serum 25(OH)D and bone mineral density (BMD) status from baseline; and incidence of new vertebral fractures at 24 months.
RESULTS
In 475 denosumab-treated and 481 placebo-treated subjects, proportions with deficient/insufficient/sufficient 25(OH)D at baseline were 53.1%/37.1%/9.9% and 50.9%/42.0%/7.1%, respectively. Supplementation significantly increased mean serum 25(OH)D levels; at 24 months, mean levels were > 30 ng/mL (sufficient) in both treatment groups. Increase in BMD over time was higher in the denosumab group vs. placebo group in all three vitamin D status groups. At month 24, denosumab-treated subjects with deficient/insufficient baseline 25(OH)D had a significantly lower risk of new vertebral fracture vs. placebo-treated subjects.
CONCLUSION
Among DIRECT trial subjects supplemented with ≥ 400 IU/day of vitamin D and ≥ 600 mg/day of Ca, baseline 25(OH)D sufficiency may not influence the efficacy of denosumab in increasing BMD or preventing vertebral fractures.",2020,Increase in BMD over time was higher in the denosumab group vs. placebo group in all three vitamin D status groups.,['30'],"['vitamin D and calcium (Ca', 'denosumab or placebo, plus vitamin D', 'denosumab co-administered with vitamin D and Ca', 'vitamin D and\u2009≥', 'denosumab', 'denosumab co-administered with vitamin D and Ca by baseline vitamin D status', 'placebo']","['serum 25(OH)D and bone mineral density (BMD) status from baseline; and incidence of new vertebral fractures', 'mean serum 25(OH)D levels', 'absolute serum 25(OH)D level', 'risk of new vertebral fracture', 'BMD over time', 'baseline serum 25-hydroxy vitamin D (25[OH]D) level influences the efficacy']",[],"[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.404153,Increase in BMD over time was higher in the denosumab group vs. placebo group in all three vitamin D status groups.,"[{'ForeName': 'Toshitsugu', 'Initials': 'T', 'LastName': 'Sugimoto', 'Affiliation': 'Eikokai Ono Hospital, Tenjincho 973, Ono City, Hyogo, 675-1316, Japan. sugimoto@med.shimane-u.ac.jp.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Fujii Memorial Institute of Medical Sciences, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Hosoi', 'Affiliation': 'Kenkoin Clinic, Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Shiraki', 'Affiliation': 'Research Institute and Practice for Involutional Diseases, Nagano, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Medical Science Department, Medical Affairs Division, Daiichi Sankyo Co. Ltd, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Okubo', 'Affiliation': 'Biostatistics & Data Management Department, R&D Division, Daiichi Sankyo Co. Ltd, Tokyo, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Takami', 'Affiliation': 'Development Function, R&D Division, Daiichi Sankyo Co. Ltd, Tokyo, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Touto Sangenjaya Rehabilitation Hospital, Tokyo, Japan.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-020-01119-9']
1150,31811480,"Efficacy of oral administration of cystine and theanine in colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery: a multi-institutional, randomized, double-blinded, placebo-controlled, phase II trial (JORTC-CAM03).","PURPOSE
Capecitabine-based adjuvant chemotherapy for colorectal cancer patients often causes adverse events (AEs), such as diarrhea, stomatitis, anorexia, and hand-foot syndrome (HFS). Cystine and theanine were reported to attenuate some chemotherapy-associated AEs, and hence are also expected to attenuate capecitabine-induced AEs. Therefore, we aimed to investigate the safety and efficacy of cystine/theanine treatment in colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery.
METHODS
A total of 100 colorectal cancer patients treated with capecitabine as an adjuvant chemotherapy after surgery were randomly allocated into the cystine/theanine group (n = 52) or the placebo group (n = 48). The primary endpoint was incidence rate of diarrhea of grade 1 or higher in accordance with the Common Terminology Criteria for AEs (CTCAE) v.4.0, Japanese Clinical Oncology Group (JCOG) version. The secondary endpoints included incidence rates of other AEs (CTCAE v.4.0-JCOG), as well as the incidence rate of HFS according to the HFS grading scale.
RESULTS
There were no significant differences in capecitabine-induced AEs between the two groups. However, the incidence rate of diarrhea of grade 1 or higher tended to be lower in the cystine/theanine group than the placebo group (18.4% vs. 28.9%, p = 0.169) as well as the incidence rate of HFS of grade 1 or higher (CTCAE v.4.0-JCOG or HFS grading scale) (67.4% vs. 77.8%, p = 0.185, 67.3% vs. 80.0%, p = 0.124, respectively).
CONCLUSION
This trial demonstrated that cystine/theanine treatment of colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery is safe and has the tendency to reduce the incidence rate of diarrhea or HFS.
TRIAL REGISTRATION
UMIN000024784.",2020,There were no significant differences in capecitabine-induced AEs between the two groups.,"['100 colorectal cancer patients treated with', 'colorectal cancer patients undergoing', 'as an adjuvant chemotherapy after surgery', 'colorectal cancer patients', 'colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery']","['Cystine and theanine', 'capecitabine-based adjuvant chemotherapy', 'cystine/theanine treatment', 'capecitabine', 'Capecitabine-based adjuvant chemotherapy', 'cystine and theanine', 'cystine/theanine', 'placebo']","['incidence rate of diarrhea of grade 1 or higher in accordance with the Common Terminology Criteria for AEs (CTCAE', 'incidence rate of diarrhea', 'safety and efficacy', 'incidence rates of other AEs (CTCAE v.4.0-JCOG), as well as the incidence rate of HFS according to the HFS grading scale', 'incidence rate of HFS of grade 1 or higher (CTCAE v.4.0-JCOG or HFS grading scale']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0010682', 'cui_str': 'Cystine'}, {'cui': 'C0076380', 'cui_str': 'theanine'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0028275', 'cui_str': 'Terminology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1274034', 'cui_str': 'Clinical oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",100.0,0.573596,There were no significant differences in capecitabine-induced AEs between the two groups.,"[{'ForeName': 'Reo', 'Initials': 'R', 'LastName': 'Hamaguchi', 'Affiliation': 'Department of Palliative Medicine, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan. reo-h@nifty.com.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Gastroenterological Surgery, Sendai City Medical Center, Sendai Open Hospital, Sendai, Miyagi, Japan.'}, {'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Miyata', 'Affiliation': 'Department of Gastroenterological Surgery, Iwate Prefectural Central Hospital, Morioka, Iwate, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Colorectal Surgery, Tohoku Rosai Hospital, Sendai, Miyagi, Japan.'}, {'ForeName': 'Koh', 'Initials': 'K', 'LastName': 'Miura', 'Affiliation': 'Department of Surgery, Miyagi Cancer Center, Sendai, Miyagi, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Oshio', 'Affiliation': 'Department of Surgery, Sendai Medical Center, Sendai, Miyagi, Japan.'}, {'ForeName': 'Hisatsugu', 'Initials': 'H', 'LastName': 'Ohori', 'Affiliation': 'Department of Clinical Oncology, Ishinomaki Red Cross Hospital, Ishinomaki, Miyagi, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Ariyoshi', 'Affiliation': 'JORTC Data Center, Tokyo, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Oyamada', 'Affiliation': 'JORTC Data Center, Tokyo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwase', 'Affiliation': 'Department of Palliative Medicine, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05205-1']
1151,31823057,Benefits of using the Brief Pain Inventory in patients with cancer pain: an intervention study conducted in Swedish hospitals.,"PURPOSE
The prevalence of cancer pain is too high. There is a need for improvement of pain management in cancer care. The aim of this study was to explore whether the use of the multidimensional pain assessment questionnaire Brief Pain Inventory (BPI) could improve pain relief in hospitalized patients with cancer.
METHODS
A controlled intervention study was performed at two hospitals in western Sweden, 264 patients were included, 132 formed a control group and 132 an intervention group. All participants completed the BPI and the Edmonton Symptom Assessment Scale (ESAS) at baseline. Only the researcher had access to questionnaires from the control group. The completed forms from the intervention group were presented to the patients' care team. A follow-up took place after 2-5 days when patients in both groups rated the scales a second time.
RESULTS
In the intervention group, significant differences in all measured items of the BPI were found at follow-up compared with baseline. Symptoms rated with the ESAS also decreased significantly, except shortness of breath. At follow-up, a significant increase in regular use of paracetamol, anti-neuropathic pain drugs and opioids was found, as well as elevated doses of fixed-schedule opioids. In the control group, differences between baseline and follow-up were significant regarding average pain and worst pain over the past 24 h.
CONCLUSION
Presenting the patient-reported BPI to the care team helped them to focus on patients' pain, identify pain mechanisms and adjust analgesics accordingly. A possible explanation for the results is changes in the medication prescribed.",2020,"In the control group, differences between baseline and follow-up were significant regarding average pain and worst pain over the past 24 h.
CONCLUSION
Presenting the patient-reported BPI to the care team helped them to focus on patients' pain, identify pain mechanisms and adjust analgesics accordingly.","['patients with cancer pain', 'two hospitals in western Sweden, 264 patients were included, 132 formed a control group and 132 an intervention group', 'hospitalized patients with cancer', 'Swedish hospitals']","['Brief Pain Inventory', 'multidimensional pain assessment questionnaire Brief Pain Inventory (BPI']","['regular use of paracetamol, anti-neuropathic pain drugs and opioids', 'pain relief', 'BPI', 'average pain and worst pain', 'except shortness of breath', 'BPI and the Edmonton Symptom Assessment Scale (ESAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",264.0,0.0362389,"In the control group, differences between baseline and follow-up were significant regarding average pain and worst pain over the past 24 h.
CONCLUSION
Presenting the patient-reported BPI to the care team helped them to focus on patients' pain, identify pain mechanisms and adjust analgesics accordingly.","[{'ForeName': 'Viveka', 'Initials': 'V', 'LastName': 'Andersson', 'Affiliation': 'The Sahlgrenska Academy, Institute of Health and Care Sciences, University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden. viveka.andersson@regionhalland.se.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bergman', 'Affiliation': 'Primary Health Care Unit, Department of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden.'}, {'ForeName': 'Ingela', 'Initials': 'I', 'LastName': 'Henoch', 'Affiliation': 'The Sahlgrenska Academy, Institute of Health and Care Sciences, University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Simonsson', 'Affiliation': 'Department of Surgery, Hallands Hospital Halmstad, Lasarettsvägen, 302 42, Halmstad, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ahlberg', 'Affiliation': 'The Sahlgrenska Academy, Institute of Health and Care Sciences, University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05200-6']
1152,32602373,The effects of small-needle-knife therapy on pain and mobility from knee osteoarthritis: a pilot randomized-controlled study.,"OBJECTIVE
To investigate the effect of small needle-knife therapy in people with painful knee osteoarthritis.
DESIGN
Pilot randomised, controlled trial.
SETTING
Rehabilitation hospital.
SUBJECTS
In-patients with osteo-arthritis of the knee.
INTERVENTIONS
Either 1 to 3 small needle-knife treatments over seven days or oral Celecoxib. All patients stayed in hospital three weeks, receiving the same mobility-focused rehabilitation.
MEASURES
Oxford Knee Score (OKS), gait speed and kinematics were recorded at baseline, at three weeks (discharge) and at three-months (OKS only). Withdrawal from the study, and adverse events associated with the small needle knife therapy were recorded.
RESULTS
83 patients were randomized: 44 into the control group, of whom 10 were lost by three weeks and 12 at 3 months; 39 into the experimental group of whom eight were lost at three weeks and three months. The mean (SE) OKS scores at baseline were Control 35.86 (1.05), Exp 38.38 (0.99); at three weeks 26.64 (0.97) and 21.94 (1.23); and at three months 25.83 (0.91) and 20.48 (1.14) The mean (SE) gait speed at baseline was 1.07 (0.03) m/sec (Control) and 0.98 (0.03), and at three weeks was 1.14 (0.03) and 1.12 (0.03) ( P < 0.05). Linear mixed model statistical analysis showed that the improvements in the experimental group were statistically significant for total OKS score at discharge and three months.
CONCLUSIONS
Small needle-knife therapy added to standard therapy for patients with knee osteoarthritis, was acceptable, safe and reduced pain and improved global function on the Oxford Knee Score. Further research is warranted.",2020,"Linear mixed model statistical analysis showed that the improvements in the experimental group were statistically significant for total OKS score at discharge and three months.
","['Rehabilitation hospital', 'people with painful knee osteoarthritis', 'In-patients with osteo-arthritis of the knee', 'knee osteoarthritis', '83 patients', 'patients with knee osteoarthritis']","['small needle-knife therapy', 'small needle knife therapy', 'Celecoxib', 'small-needle-knife therapy', 'Small needle-knife therapy']","['pain and mobility', 'Oxford Knee Score (OKS), gait speed and kinematics', 'mean (SE) OKS scores', 'total OKS score', 'mean (SE) gait speed', 'safe and reduced pain and improved global function']","[{'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0240111', 'cui_str': 'Arthritis of knee'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0181464', 'cui_str': 'Needle knife'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",83.0,0.0422692,"Linear mixed model statistical analysis showed that the improvements in the experimental group were statistically significant for total OKS score at discharge and three months.
","[{'ForeName': 'Junchen', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'The Department of Orthopaedics, the Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui Province, China.'}, {'ForeName': 'Zhiwen', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'The Department of Orthopaedics, the Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui Province, China.'}, {'ForeName': 'Yaomeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Centre for Movement and Occupational Rehabilitation Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Lawrie', 'Affiliation': 'Centre for Movement and Occupational Rehabilitation Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Esser', 'Affiliation': 'Centre for Movement and Occupational Rehabilitation Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Hooshang', 'Initials': 'H', 'LastName': 'Izadi', 'Affiliation': 'Centre for Movement and Occupational Rehabilitation Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dawes', 'Affiliation': 'Centre for Movement and Occupational Rehabilitation Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Zhidao', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': 'Centre for Movement and Occupational Rehabilitation Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The Department of Orthopaedics, the Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui Province, China.'}, {'ForeName': 'Yingzong', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'The Department of Orthopaedics, the Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui Province, China.'}, {'ForeName': 'Xingfu', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'The Department of Orthopaedics, the Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui Province, China.'}, {'ForeName': 'Derick T', 'Initials': 'DT', 'LastName': 'Wade', 'Affiliation': 'Centre for Movement and Occupational Rehabilitation Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}]",Clinical rehabilitation,['10.1177/0269215520938852']
1153,32599644,The Effects of Performing Mental Exertion during Cycling Exercise on Fatigue Indices.,"This study investigated the effect of performing prolonged mental exertion during submaximal cycling exercise on exercise tolerance and fatigue. Participants performed 5 experimental sessions. Session 1: determination of cycling peak power output. Sessions 2 and 3: cycling to exhaustion at 65% peak power output with mental exertion or watching a movie. Sessions 4 and 5: cycling for 45 min at 65% peak power output with mental exertion or while watching a movie. During sessions 2-5, rate of perceived exertion and heart rate were recorded while cycling and cortisol and prolactin concentrations, psychomotor vigilance task performance, and maximal voluntary contraction were measured pre-and post-sessions. During sessions 2 and 3, time to exhaustion was reduced ( p <0.01) and rate of perceived exertion was increased ( p <0.01) in session 2 compared to 3. Cortisol, prolactin and heart rate increased and psychomotor vigilance task and maximal voluntary contraction decreased from pre-to post-sessions with no difference between sessions. Cortisol, prolactin and rate of perceived exertion were higher ( p <0.03) in session 4 than 5. Heart rate increased and maximal voluntary contraction decreased from pre-to post-sessions with no difference between sessions. Prolonged mental exertion during cycling exercise reduces exercise tolerance, which appears to be mediated psychologically rather than physiologically.",2020,"Cortisol, prolactin and rate of perceived exertion were higher ( p <0.03) in session 4 than 5.",[],"['Performing Mental Exertion during Cycling Exercise', 'Sessions 2 and 3: cycling to exhaustion at 65% peak power output with mental exertion or watching a movie', 'Sessions 4 and 5: cycling for 45 min at 65% peak power output with mental exertion or while watching a movie', 'performing prolonged mental exertion during submaximal cycling exercise']","['Cortisol, prolactin and heart rate increased and psychomotor vigilance task and maximal voluntary contraction', 'rate of perceived exertion and heart rate', 'Heart rate increased and maximal voluntary contraction', 'cycling and cortisol and prolactin concentrations, psychomotor vigilance task performance, and maximal voluntary contraction', 'time to exhaustion', 'exercise tolerance and fatigue', 'rate of perceived exertion', 'Cortisol, prolactin and rate of perceived exertion', 'Fatigue Indices']",[],"[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0531489,"Cortisol, prolactin and rate of perceived exertion were higher ( p <0.03) in session 4 than 5.","[{'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Barzegarpoor', 'Affiliation': 'Sport Sciences and Health, Shahid Beheshti University, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Amoozi', 'Affiliation': 'Sport Sciences and Health, Shahid Beheshti University, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rajabi', 'Affiliation': 'Sport sciences, Kharazmi University, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Button', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, Canada.""}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Fayazmilani', 'Affiliation': 'Sport Sciences and Health, Shahid Beheshti University, Tehran, Iran (the Islamic Republic of).'}]",International journal of sports medicine,['10.1055/a-1179-8326']
1154,32627420,"A Randomized, Double-Blind Study Comparing Pharmacokinetics and Pharmacodynamics of Proposed Biosimilar ABP 798 With Rituximab Reference Product in Subjects With Moderate to Severe Rheumatoid Arthritis.","ABP 798 is a proposed biosimilar to rituximab reference product (RP), an anti-CD20 monoclonal antibody. Pharmacokinetics (PK), pharmacodynamics (PD), and safety results from the comparative clinical study that evaluated the PK, PD, safety, efficacy, and immunogenicity of ABP 798 versus rituximab RP are presented here. Subjects with moderate to severe rheumatoid arthritis (RA) received 2 doses of ABP 798, United States-sourced RP (rituximab US) or European Union-sourced RP (rituximab EU), each consisting of two 1000-mg infusions 2 weeks apart. For the second dose (week 24), ABP 798- and rituximab EU-treated subjects received the same treatment; rituximab US-treated subjects transitioned to ABP 798. End points included area under the serum concentration-time curve from time 0 extrapolated to infinity and maximum observed serum concentration following the second infusion of the first dose (PK) and percentage of subjects with complete CD19+ cell depletion days 1-33 (PD). Primary analysis established PK similarity between ABP 798 and rituximab RP based on 90% confidence intervals of the adjusted geometric mean ratios being within a prespecified equivalence margin of 0.8 and 1.25. Complete CD19+ B-cell depletion on day 3 among groups confirmed PD similarity. These findings demonstrated PK/PD similarity between ABP 798 and rituximab RP in subjects with moderate to severe RA.",2020,Primary analysis established PK similarity between ABP 798 and rituximab RP based on 90% confidence intervals of the adjusted geometric mean ratios being within a prespecified equivalence margin of 0.8 and 1.25.,"['Subjects With Moderate to Severe Rheumatoid Arthritis', 'subjects with moderate to severe RA', 'Subjects with moderate to severe rheumatoid arthritis (RA']","['ABP 798, United States-sourced RP (rituximab US) or European Union-sourced RP (rituximab EU']","['PK, PD, safety, efficacy, and immunogenicity', 'Complete CD19+ B-cell depletion', 'area under the serum concentration-time curve', 'Pharmacokinetics (PK), pharmacodynamics (PD), and safety']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0001239', 'cui_str': 'Actin-binding protein'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0015179', 'cui_str': 'European Community'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.0433337,Primary analysis established PK similarity between ABP 798 and rituximab RP based on 90% confidence intervals of the adjusted geometric mean ratios being within a prespecified equivalence margin of 0.8 and 1.25.,"[{'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Burmester', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Clinical R&D, Biosimilars, Amgen Inc., Thousand Oaks, California, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chow', 'Affiliation': 'Clinical Pharmacology M&S, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Gessner', 'Affiliation': 'Clinical Immunology, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Clinical R&D, Biosimilars, Amgen Inc., Thousand Oaks, California, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, Dallas, Texas, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.845']
1155,32632661,Correction to: No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial.,"On request from the Editors, the authors would like to clarify the following: the patient cohorts in the publications ""No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial"".",2020,"On request from the Editors, the authors would like to clarify the following: the patient cohorts in the publications ""No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial"".","['percutaneous palliation of malignant hilar biliary obstruction', 'malignant hilar biliary obstruction']",[],[],"[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0400979', 'cui_str': 'Obstruction of biliary tree'}]",[],[],,0.0447173,"On request from the Editors, the authors would like to clarify the following: the patient cohorts in the publications ""No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial"".","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Dhondt', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium. elisabeth.dhondt@uzgent.be.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vanlangenhove', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Geboes', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Vandenabeele', 'Affiliation': 'Department of Gastroenterology, Saint-Joseph Clinic Bornem and Willebroek, Bornem, Belgium.'}, {'ForeName': 'Lien', 'Initials': 'L', 'LastName': 'Van Cauwenberghe', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Defreyne', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}]",European radiology,['10.1007/s00330-020-07029-8']
1156,32636043,Early Mobilization After Volar Locking Plate Osteosynthesis of Distal Radial Fractures in Older Patients-A Randomized Controlled Trial.,"PURPOSE
To investigate if early mobilization after open reduction internal fixation of distal radius fractures improved the functional outcome. We hypothesized that early mobilization would lead to improved patient-reported outcome. Second, we aimed to assess whether early mobilization increased the risk of postoperative implant loosening or breakage.
METHODS
All included patients were treated with a volar locking plate. After surgery, patients were randomized to either early mobilization (E-MOB) with a removable orthosis (wrist lacer) and daily wrist exercises or to late mobilization (L-MOB) with a standard dorsal plaster cast for 2 weeks and, after that, a removable orthosis and exercises. We measured all patients at 4 weeks and at 3, 6, and 12 months after surgery. At each postoperative visit, we measured range of motion and grip strength and patients filled out the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Radiographic implant loosening or breakage was assessed 14 days after surgery.
RESULTS
A total of 47 patients were allocated to E-MOB and 48 to L-MOB. The DASH score improved substantially throughout the follow-up period with no significant differences between the 2 groups at any time point. Implant loosening and fracture redisplacement was observed in 1 patient in the E-MOB group. Range of motion and grip strength were similar between the 2 groups at all time points.
CONCLUSIONS
Early mobilization after surgical treatment of distal radius fractures does not lead to improved patient-reported outcome.
TYPE OF STUDY/LEVEL OF EVIDENCE
Therapeutic I.",2020,The DASH score improved substantially throughout the follow-up period with no significant differences between the 2 groups at any time point.,"['47 patients', 'Older Patients']","['Volar Locking Plate Osteosynthesis', 'early mobilization (E-MOB) with a removable orthosis (wrist lacer) and daily wrist exercises or to late mobilization (L-MOB) with a standard dorsal plaster cast', 'volar locking plate']","['range of motion and grip strength and patients filled out the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire', 'Implant loosening and fracture redisplacement', 'Early Mobilization', 'Radiographic implant loosening or breakage', 'DASH score', 'Range of motion and grip strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C4727954', 'cui_str': 'Plate osteosynthesis'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0454328', 'cui_str': 'Wrist exercises'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0032159', 'cui_str': 'Plaster cast'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",47.0,0.0688753,The DASH score improved substantially throughout the follow-up period with no significant differences between the 2 groups at any time point.,"[{'ForeName': 'Thomas Juul', 'Initials': 'TJ', 'LastName': 'Sørensen', 'Affiliation': 'Department of Orthopedic Surgery, Zealand University Hospital, Køge.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Ohrt-Nissen', 'Affiliation': 'Department of Orthopedic Surgery, Zealand University Hospital, Køge. Electronic address: ohrtnissen@gmail.com.'}, {'ForeName': 'Kecia V', 'Initials': 'KV', 'LastName': 'Ardensø', 'Affiliation': 'Department of Occupational and Physiotherapy, Zealand University Hospital, Køge.'}, {'ForeName': 'Gunnar H', 'Initials': 'GH', 'LastName': 'Laier', 'Affiliation': 'Production, Research and Innovation, Region Zealand, Denmark.'}, {'ForeName': 'Susanne K', 'Initials': 'SK', 'LastName': 'Mallet', 'Affiliation': 'Department of Orthopedic Surgery, Zealand University Hospital, Køge.'}]",The Journal of hand surgery,['10.1016/j.jhsa.2020.05.009']
1157,32640945,High-Sensitivity Cardiac Troponin T for Risk Stratification in Patients With Embolic Stroke of Undetermined Source.,"BACKGROUND AND PURPOSE
Optimal secondary prevention for patients with embolic stroke of undetermined source (ESUS) remains unknown. We aimed to assess whether high-sensitivity cardiac troponin T (hs-cTnT) levels are associated with major vascular events and whether hs-cTnT may identify patients who benefit from anticoagulation following ESUS.
METHODS
Data were obtained from the biomarker substudy of the NAVIGATE ESUS trial, a randomized controlled trial testing the efficacy of rivaroxaban versus aspirin for secondary stroke prevention in ESUS. Patients were dichotomized at the hs-cTnT upper reference limit (14 ng/L, Gen V, Roche Diagnostics). Cox proportional hazard models were computed to explore the association between hs-cTnT, the combined cardiovascular end point (recurrent stroke, myocardial infarction, systemic embolism, cardiovascular death), and recurrent ischemic stroke.
RESULTS
Among 1337 patients enrolled at 111 participating centers in 18 countries (mean age 67±9 years, 61% male), hs-cTnT was detectable in 95% and at/above the upper reference limit in 21%. During a median follow-up of 11 months, the combined cardiovascular end point occurred in 68 patients (5.0%/y, rivaroxaban 28 events, aspirin 40 events; hazard ratio, 0.67 [95% CI, 0.41-1.1]), and recurrent ischemic stroke occurred in 50 patients (4.0%/y, rivaroxaban 16 events, aspirin 34 events, hazard ratio 0.45 [95% CI, 0.25-0.81]). Annualized combined cardiovascular end point rates were 8.2% (9.5% rivaroxaban, 7.0% aspirin) for those above hs-cTnT upper reference limit and 4.8% (3.1% rivaroxaban, 6.6% aspirin) below with a significant treatment modification ( P =0.04). Annualized ischemic stroke rates were 4.7% above hs-cTnT upper reference limit and 3.9% below, with no suggestion of an interaction between hs-cTnT and treatment ( P =0.3).
CONCLUSIONS
In patients with ESUS, hs-cTnT was associated with increased cardiovascular event rates. While fewer recurrent strokes occurred in patients receiving rivaroxaban, outcomes were not stratified by hs-cTn results. Our findings support using hs-cTnT for cardiovascular risk stratification but not for decision-making regarding anticoagulation therapy in patients with ESUS. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02313909.",2020,"In patients with ESUS, hs-cTnT was associated with increased cardiovascular event rates.","['secondary stroke prevention in ESUS', '1337 patients enrolled at 111 participating centers in 18 countries (mean age 67±9 years, 61% male), hs-cTnT was detectable in 95% and at/above the upper reference limit in 21', 'patients with ESUS', 'patients with embolic stroke of undetermined source (ESUS', 'patients who benefit from anticoagulation following ESUS', 'Patients With Embolic Stroke of Undetermined Source']","['rivaroxaban', 'High-Sensitivity Cardiac Troponin T', 'rivaroxaban versus aspirin']","['combined cardiovascular end point (recurrent stroke, myocardial infarction, systemic embolism, cardiovascular death), and recurrent ischemic stroke', 'cardiovascular event rates', 'Annualized combined cardiovascular end point rates', 'recurrent strokes', 'recurrent ischemic stroke', 'Annualized ischemic stroke rates']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",1337.0,0.250989,"In patients with ESUS, hs-cTnT was associated with increased cardiovascular event rates.","[{'ForeName': 'Jan F', 'Initials': 'JF', 'LastName': 'Scheitz', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Germany (J.F.S., C.H.N., M.E.).'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Pare', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada (G.P.).'}, {'ForeName': 'Lesly A', 'Initials': 'LA', 'LastName': 'Pearce', 'Affiliation': 'Biostatistics Consultant, Minot, ND (L.A.P.).'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany (H.M., T.K.).'}, {'ForeName': 'W Frank', 'Initials': 'WF', 'LastName': 'Peacock', 'Affiliation': 'Baylor College of Medicine, Houston, TX (W.F.P.).'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Czlonkowska', 'Affiliation': '2nd Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland (A.C.).'}, {'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine (Neurology), Population Health Research Institute, McMaster University, Hamilton Health Sciences, Canada (M.S., A.S.).'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Nolte', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Germany (J.F.S., C.H.N., M.E.).'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'Department of Medicine (Neurology), Population Health Research Institute, McMaster University, Hamilton Health Sciences, Canada (M.S., A.S.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Research & Development, Pharmaceuticals, Bayer U.S., LLC, Whippany (S.D.B.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Krahn', 'Affiliation': 'Bayer AG, Wuppertal, Germany (H.M., T.K.).'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Germany (J.F.S., C.H.N., M.E.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.120.029628']
1158,32640956,Comparison of the Effects of Fenugreek Vaginal Cream and Ultra Low- Dose Estrogen on Atrophic Vaginitis.,"INTRODUCTION
Atrophic vaginitis is a common problem in postmenopausal women and results from decreased levels of blood estrogen. It is associated with symptoms of itching, burning, dyspareunia, and postmenopausal bleeding. The present study evaluated the effects of fenugreek extract on atrophic vaginitis.
MATERIALS AND METHODS
This randomized controlled clinical trial was performed on 60 postmenopausal women in Ardabil, Iran, in 2018. The participants were selected using block randomization with the allocation ratio 1:1. Those in the intervention group received 0.5g (the applicator filled to the half-full mark) fenugreek vaginal cream 5% twice a week for 12 weeks. The control group received conjugated estrogens vaginal cream at the dose of 0.625 mg (the applicator filled to the half-full mark) containing 0.3 mg of conjugated estrogens. Atrophic vaginitis was evaluated before and after the treatment through clinical examination, clinical signs, and measurement of Vaginal Maturation Index (VMI).
FINDINGS
After the 12-week intervention and modification of the baseline score, the mean (standard error) score for atrophic vaginitis signs was 3.100 (1.43-4.75). This difference was statistically significant in intragroup comparison and in favor of the control group in intergroup comparison (p=0.001). VMI was less than 49% in 86.7% and 46.7% of the participants in the intervention and control groups, respectively. This was a significant difference in favor of the control group (p=0.001).
CONCLUSION
The results of this study showed that total fenugreek extract could be effective in treating signs of atrophic vaginitis, but it was not as effective as ultra-low-dose estrogen.",2020,This difference was statistically significant in intragroup comparison and in favor of the control group in intergroup comparison (p=0.001).,"['Atrophic Vaginitis', '60 postmenopausal women in Ardabil, Iran, in 2018', 'postmenopausal women']","['Fenugreek Vaginal Cream and Ultra Low-Dose Estrogen', 'conjugated estrogens vaginal cream at the dose of 0.625 mg (the applicator filled to the half-full mark) containing 0.3 mg of conjugated estrogens', 'fenugreek extract']","['vaginal maturation index (VMI', 'mean (standard error) score for atrophic vaginitis signs', 'atrophic vaginitis', 'VMI', 'symptoms of itching, burning, dyspareunia, and postmenopausal bleeding', 'Atrophic vaginitis']","[{'cui': 'C0156409', 'cui_str': 'Postmenopausal atrophic vaginitis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0060207', 'cui_str': 'Fenugreek'}, {'cui': 'C0042238', 'cui_str': 'Vaginal cream'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0014938', 'cui_str': 'Estrogens, Conjugated (USP)'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517467', 'cui_str': '0.625'}, {'cui': 'C0179108', 'cui_str': 'Applicator'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0156409', 'cui_str': 'Postmenopausal atrophic vaginitis'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]",60.0,0.0493959,This difference was statistically significant in intragroup comparison and in favor of the control group in intergroup comparison (p=0.001).,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Safary', 'Affiliation': 'School of Nursing and Midwifery, Tabriz University of Medical Science, Tabriz, Iran.'}, {'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Hakimi', 'Affiliation': 'School of Nursing and Midwifery, Research Center of Psychiatry and Behavioral Science, Tabriz University of Medical Science, Tabriz, Iran.'}, {'ForeName': 'Noushin', 'Initials': 'N', 'LastName': 'Mobaraki-Asl', 'Affiliation': 'School of Medicine, Ardabil University of Medical Science, Ardabil, Iran.'}, {'ForeName': 'Paria', 'Initials': 'P', 'LastName': 'Amiri', 'Affiliation': 'School of Nursing and Midwifery, Tabriz University of Medical Science, Tabriz, Iran.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Tvassoli', 'Affiliation': 'School of Medicine, Ardabil University of Medical Science, Ardabil, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Delazar', 'Affiliation': 'School of Pharmacy, Tabriz University of Medical Science, Tabriz, Iran.'}]",Current drug delivery,['10.2174/1567201817666200708112655']
1159,32652064,Validation of an enhanced recovery after surgery protocol in gynecologic surgery: an Italian randomized study.,"BACKGROUND
The enhanced recovery after surgery concept, which was introduced 20 years ago, is based on a multimodal approach to improve the functional rehabilitation of patients after surgery.
OBJECTIVE
This study aimed to validate an enhanced recovery after surgery protocol in gynecologic surgery for both benign and malignant diseases (endometrial cancer and advanced ovarian cancer) and to measure the adherence to the enhanced recovery after surgery protocol items in a randomized trial setting.
STUDY DESIGN
In this trial (NCT03347409), we randomly assigned patients to undergo standard perioperative care or enhanced recovery after surgery protocol. The primary outcome is a shorter length of stay in favor of the enhanced recovery after surgery protocol. Secondary outcomes include measurement of adherence to the enhanced recovery after surgery protocol items: comparison of postoperative pain, vomiting, and nausea; anesthesiologic and surgical complications up to 30 days after surgery; rate of readmissions; the time to event in hours for bowel movements, flatus, drinking, hunger, eating, and walking; and the quality of recovery using a validated questionnaire (QoR-15). Finally, we explored the length of stay in the prespecified subgroups at randomization, based on the type of surgical access and gynecologic disease.
RESULTS
A total of 168 women were available for analysis: 85 women (50.6%) were assigned to the standard perioperative care group, and 83 women (49.4%) were assigned to the enhanced recovery after surgery protocol group. The 2 groups were similar for age, body mass index, comorbidities, anesthesiological risk, smoking habits, surgical access, and complexity of surgical procedures. Seventy-two patients (42.9%) underwent surgery for benign disease, 48 (28.6%) for endometrial cancer, and 48 (28.6%) for ovarian cancer. Women in the enhanced recovery after surgery protocol group had a shorter length of stay (median: 2 [interquartile range, 2-3] vs 4 [interquartile range, 4-7] days; P<.001). A decreased rate of postoperative complications was noted for the enhanced recovery after surgery protocol group, as well as an earlier time to occur for all the events. Mean adherence to protocol items was 84.8% (95% confidence interval, 79.7-89.8), and we registered a better satisfaction in the enhanced recovery after surgery protocol group. The shortening of the length of stay was confirmed also in the prespecified subgroup analysis.
CONCLUSION
Application of the enhanced recovery after surgery protocol in gynecologic surgery translated to a shorter length of stay regardless of surgical access and type of gynecologic disease. Adherence to the enhanced recovery after surgery protocol items in the setting of a randomized trial was high.",2020,"The two groups were similar for age, BMI, comorbidities, anesthesiological risk, smoking habits, surgical access and complexity of surgical procedures.","['gynecological surgery', 'gynecological surgery both for benign and malignant disease (endometrial cancer and advanced ovarian cancer', 'A total of 168 women were available for analysis, of them 85 (50.6%) underwent standard perioperative care while 83 (49.4%) were assigned to']","['ERAS protocol', 'standard perioperative care or ERAS protocol', 'ERAS', 'surgery (ERAS) protocol']","['shortening of the length of stay', 'Mean adherence to protocol items', 'shorter length of stay in favor of ERAS', 'shorter length of stay, regardless of surgical access and type of gynecological disease', 'measurement of adherence to ERAS items, comparison of postoperative pain, vomiting and nausea, anesthesiological and surgical complications up to thirty days after surgery, rate of readmissions, the time-to-event in hours for bowel movements, flatus, drink, hunger, eating and walking and lastly the quality of recovery using a validated questionnaire (QoR 15', 'shorter length of stay', 'rate of postoperative complications']","[{'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0017411', 'cui_str': 'Disorder of female genital organs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",168.0,0.160542,"The two groups were similar for age, BMI, comorbidities, anesthesiological risk, smoking habits, surgical access and complexity of surgical procedures.","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ferrari', 'Affiliation': 'Department of Obstetrics and Gynecology, Spedali Civili, Brescia, Italy. Electronic address: f.ferrari.obgyn@gmail.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Forte', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Sbalzer', 'Affiliation': 'Department of Anesthesia, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Zizioli', 'Affiliation': 'Department of Obstetrics and Gynecology, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Mauri', 'Affiliation': 'Department of Obstetrics and Gynecology, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Maggi', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Sartori', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Odicino', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.07.003']
1160,32660350,The Possession of High Status Strengthens the Status Motive.,"The current research tested whether the possession of high status, compared with the possession of low status, makes individuals desire having high status even more. Five studies (total N = 6,426), four of which were preregistered, supported this hypothesis. Individuals with higher status in their social groups or who were randomly assigned to a high-status condition were more motivated to have high status than were individuals with low status. Furthermore, upper-class individuals had a stronger status motive than working-class individuals, in part, due to their high status. High-status individuals had a stronger status motive, in part, because they were more confident in their ability to achieve (or retain) high status, but not because of other possible mechanisms (e.g., task self-efficacy). These findings provide a possible explanation for why status hierarchies are so stable and why inequality rises in social collectives over time.",2020,These findings provide a possible explanation for why status hierarchies are so stable and why inequality rises in social collectives over time.,['Individuals with higher status in their social groups'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0687744', 'cui_str': 'Social group'}]",[],[],,0.0120696,These findings provide a possible explanation for why status hierarchies are so stable and why inequality rises in social collectives over time.,"[{'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'University of California, Berkeley, USA.'}, {'ForeName': 'John Angus D', 'Initials': 'JAD', 'LastName': 'Hildreth', 'Affiliation': 'Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Daron L', 'Initials': 'DL', 'LastName': 'Sharps', 'Affiliation': 'University of California, Berkeley, USA.'}]",Personality & social psychology bulletin,['10.1177/0146167220937544']
1161,32666831,Methodologies for pragmatic and efficient assessment of benefits and harms: Application to the SOCRATES trial.,"BACKGROUND/AIMS
Standard approaches to trial design and analyses can be inefficient and non-pragmatic. Failure to consider a range of outcomes impedes evidence-based interpretation and reduces power. Traditional approaches synthesizing information obtained from separate analysis of each outcome fail to incorporate associations between outcomes and recognize the cumulative nature of outcomes in individual patients, suffer from competing risk complexities during interpretation, and since efficacy and safety analyses are often conducted on different populations, generalizability is unclear. Pragmatic and efficient approaches to trial design and analyses are needed.
METHODS
Approaches providing a pragmatic assessment of benefits and harms of interventions, summarizing outcomes experienced by patients, and providing sample size efficiencies are described. Ordinal outcomes recognize finer gradations of patient responses. Desirability of outcome ranking is an ordinal outcome combining benefits and harms within patients. Analysis of desirability of outcome ranking can be based on rank-based methodologies including the desirability of outcome ranking probability, the win ratio, and the proportion in favor of treatment. Partial credit analyses, involving grading the levels of the desirability of outcome ranking outcome similar to an academic test, provides an alternative approach. The methodologies are demonstrated using the acute stroke or transient ischemic attack treated with aspirin or ticagrelor and patient outcomes study (SOCRATES; NCT01994720), a randomized clinical trial.
RESULTS
Two 5-level ordinal outcomes were developed for SOCRATES. The first was based on a modified Rankin scale. The odds ratio is 0.86 (95% confidence interval = 0.75, 0.99; p = 0.04) indicating that the odds of worse stroke categorization for a trial participant assigned to ticagrelor is 0.86 times that of a trial participant assigned to aspirin. The 5-level desirability of outcome ranking outcome incorporated and prioritized survival; the number of strokes, myocardial infarction, and major bleeding events; and whether a stroke event was disabling. The desirability of outcome ranking probability and win ratio are 0.504 (95% confidence interval = 0.499, 0.508; p = 0.10) and 1.11 (95% confidence interval = 0.98, 1.26; p = 0.10), respectively, implying that the probability of a more desirable result with ticagrelor is 50.4% and that a more desirable result occurs 1.11 times more frequently on ticagrelor versus aspirin.
CONCLUSION
Ordinal outcomes can improve efficiency through required pre-specification, careful construction, and analyses. Greater pragmatism can be obtained by composing outcomes within patients. Desirability of outcome ranking provides a global assessment of the benefits and harms that more closely reflect the experience of patients. The desirability of outcome ranking probability, the proportion in favor of treatment, the win ratio, and partial credit can more optimally inform patient treatment, enhance the understanding of the totality of intervention effects on patients, and potentially provide efficiencies over standard analyses. The methods provide the infrastructure for incorporating patient values and estimating personalized effects.",2020,"The odds ratio is 0.86 (95% confidence interval = 0.75, 0.99; p = 0.04) indicating that the odds of worse stroke categorization for a trial participant assigned to ticagrelor is 0.86 times that of a trial participant assigned to aspirin.",[],"['aspirin', 'aspirin or ticagrelor', 'ticagrelor']","['prioritized survival; the number of strokes, myocardial infarction, and major bleeding events; and whether a stroke event was disabling']",[],"[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.138628,"The odds ratio is 0.86 (95% confidence interval = 0.75, 0.99; p = 0.04) indicating that the odds of worse stroke categorization for a trial participant assigned to ticagrelor is 0.86 times that of a trial participant assigned to aspirin.","[{'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Evans', 'Affiliation': 'Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knutsson', 'Affiliation': 'AstraZeneca, Research and Development, Gothenburg, Sweden.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': 'Department of Neurology and Stroke Centre, Bichat Hospital, Paris University, Paris, France.'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'Stanford Stroke Center, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Denison', 'Affiliation': 'AstraZeneca, Research and Development, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ladenvall', 'Affiliation': 'AstraZeneca, Research and Development, Gothenburg, Sweden.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Jonasson', 'Affiliation': 'AstraZeneca, Research and Development, Gothenburg, Sweden.'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Minematsu', 'Affiliation': 'National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': ""Stroke Unit, Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Ks Lawrence', 'Initials': 'KL', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine & Therapeutics, Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Dean's Office, Dell Medical School, University of Texas at Austin, Austin, TX, USA.""}]","Clinical trials (London, England)",['10.1177/1740774520941441']
1162,32679239,Low Prognostic Value of Novel Nocturnal Metrics in Patients With OSA and High Cardiovascular Event Risk: Post Hoc Analyses of the SAVE Study.,"BACKGROUND
Traditional methods for the quantification of OSA severity may not encapsulate potential relationships between hypoxemia in OSA and cardiovascular risk.
RESEARCH QUESTION
Do novel nocturnal oxygen saturation (Spo 2 ) metrics have prognostic value in patients with OSA and high cardiovascular event risk?
STUDY DESIGN AND METHODS
We conducted post hoc analyses of the Sleep Apnea Cardiovascular Endpoints (SAVE) trial. In 2687 individuals, Cox proportional hazards models that were stratified for treatment allocation were used to determine the associations between clinical characteristics, pulse oximetry-derived metrics that were designed to quantify sustained and episodic features of hypoxemia, and cardiovascular outcomes. Metrics included oxygen desaturation index, time <90% Spo 2 , average Spo 2 for the entire recording (mean Spo 2 ), average Spo 2 during desaturation events (desaturation Spo 2 ), average baseline Spo 2 interpolated across episodic desaturation events (baseline Spo 2 ), episodic desaturation event duration and desaturation/resaturation-time ratio, and mean and SD of pulse rate.
RESULTS
Neither apnea-hypopnea index, oxygen desaturation index, nor any of the novel Spo 2 metrics were associated with the primary SAVE composite cardiovascular outcome. Mean and baseline Spo 2 were associated with heart failure (hazard ratio [HR], 0.81; 95% CI, 0.69-0.95; P = .009; and HR, 0.78; 95% CI, 0.67-0.90; P = .001, respectively) and myocardial infarction (HR, 0.86; 95% CI, 0.77-0.95; P = .003; and HR, 0.81; 95% CI, 0.73-0.90; P < .001, respectively). Desaturation duration and desaturation/resaturation time ratio, with established risk factors, predicted future heart failure (area under the curve, 0.86; 95% CI, 0.79-0.93).
INTERPRETATION
Apnea-hypopnea index and oxygen desaturation index were not associated with cardiovascular outcomes. In contrast, the pattern of oxygen desaturation was associated with heart failure and myocardial infarction. However, concomitant risk factors remained the predominant determinants for secondary cardiovascular events and thus deserve the most intensive management.",2020,"Neither AHI, ODI nor any of the novel SpO 2 metrics were associated with the primary SAVE composite CV outcome.","['patients with OSA and high cardiovascular event risk', 'patients with obstructive sleep apnea and high cardiovascular event risk']",['novel nocturnal oxygen saturation metrics'],"['oxygen desaturation index, time <90% oxygen saturation (SpO 2 ), average SpO 2 for the entire recording (mean SpO 2 ); average SpO 2 during desaturation events (desaturation SpO 2 ); average baseline SpO 2 interpolated across episodic desaturation events (baseline SpO 2 ); episodic desaturation event duration and desaturation/resaturation-time ratio; mean and standard deviation of pulse rate', 'heart failure', 'myocardial infarction', 'Desaturation duration and desaturation/resaturation-time ratio, with established risk factors, predicted future heart failure', 'heart failure and myocardial infarction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273410', 'cui_str': 'Cardiovascular event risk'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1264675', 'cui_str': 'Time ratio'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0016884', 'cui_str': 'Future'}]",,0.0539802,"Neither AHI, ODI nor any of the novel SpO 2 metrics were associated with the primary SAVE composite CV outcome.","[{'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Linz', 'Affiliation': 'Heart Rhythm Disorders (CHRD), South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia; Department of Cardiology, Maastricht University Medical Centre, Maastricht, Cardiovascular Research Institute Maastricht (CARIM), University Maastricht, Maastricht, The Netherlands; Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands. Electronic address: dominik.linz@mumc.nl.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Loffler', 'Affiliation': 'Adelaide Institute for Sleep Health (AISH), College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Prashanthan', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': 'Heart Rhythm Disorders (CHRD), South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Catcheside', 'Affiliation': 'Adelaide Institute for Sleep Health (AISH), College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Neurology Department, Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': 'George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'WeiWei', 'Initials': 'W', 'LastName': 'Quan', 'Affiliation': 'George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Department of Cardiology, Rui Jin Hospital and Institute of Cardiovascular Diseases, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Barnes', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.""}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'Adelaide Institute for Sleep Health (AISH), College of Medicine and Public Health, Flinders University, Adelaide, Australia; Sleep Health Service, Respiratory and Sleep Services, Southern Adelaide Local Health Network, Adelaide, Australia.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Baumert', 'Affiliation': 'School of Electrical and Electronic Engineering, University of Adelaide, Adelaide, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2020.06.072']
1163,32680812,The effect of manual lymphatic drainage on patient recovery after orthognathic surgery-A qualitative and 3-dimensional facial analysis.,"OBJECTIVE
The aim of this study was to investigate the effect of manual lymphatic drainage (MLD) on postoperative facial swelling and pain.
STUDY DESIGN
A randomized, single-center, prospective, 2-arm clinical trial with blinded endpoint assessment was set up. Patients were enrolled from the Maxillofacial Department of the Ghent University Hospital (Belgium) between January 2015 and March 2018. Both the intervention group (n = 13) and the control group (n = 13) received the same postoperative care; in addition, the intervention group underwent 6 sessions of MLD after orthognathic surgery. Three-dimensional facial scans were performed and questionnaires administered on postoperative days 3, 7, 14, 30, 90, and 180. A linear mixed model was performed, and statistical significance was assumed at the 5% level.
RESULTS
In total, 26 patients (mean age 29 years; range 16-57 years) were included for statistical analysis. A faster decrease in swelling in the intervention group was observed on 3-dimensional scans. Furthermore, patients receiving MLD reported reduction in swelling and pain within the first month after surgery. However, no statistically significant difference could be detected in these observations (P > .05).
CONCLUSIONS
Within the limitations of this study, no statistically significant difference could be found between patients treated with or without MLD after orthognathic surgery with regard to swelling and pain.",2020,A faster decrease in swelling in the intervention group was observed on 3-dimensional scans.,"['Patients were enrolled from the Maxillofacial Department of the Ghent University Hospital (Belgium) between January 2015 and March 2018', '26 patients (mean age 29 years; range 16-57 years']","['manual lymphatic drainage', 'manual lymphatic drainage (MLD', 'MLD']","['swelling', 'swelling and pain', 'postoperative facial swelling and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}]","[{'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}]",26.0,0.0811295,A faster decrease in swelling in the intervention group was observed on 3-dimensional scans.,"[{'ForeName': 'Fréderic E G', 'Initials': 'FEG', 'LastName': 'Van de Velde', 'Affiliation': 'Department of Orthodontics, Oral Health Sciences, Ghent University, Ghent University Hospital, Ghent, Belgium. Electronic address: Frederic.vandevelde@ugent.be.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Ortega-Castrillon', 'Affiliation': 'Department of Electrical Engineering, ESAT/PSI, KU Leuven, Heverlee, Belgium; Medical Imaging Research Center, MIRC, UZ Leuven, Leuven, Belgium.'}, {'ForeName': 'Laurent A M', 'Initials': 'LAM', 'LastName': 'Thierens', 'Affiliation': 'Department of Orthodontics, Oral Health Sciences, Ghent University, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Claes', 'Affiliation': ""Department of Electrical Engineering, ESAT/PSI, KU Leuven, Heverlee, Belgium; Medical Imaging Research Center, MIRC, UZ Leuven, Leuven, Belgium; Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Guy A M', 'Initials': 'GAM', 'LastName': 'De Pauw', 'Affiliation': 'Department of Orthodontics, Oral Health Sciences, Ghent University, Ghent University Hospital, Ghent, Belgium.'}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2020.05.017']
1164,32616559,Provider visual attention on a respiratory function monitor during neonatal resuscitation.,"BACKGROUND
A respiratory function monitor (RFM) provides real-time positive pressure ventilation feedback. Whether providers use RFM during neonatal resuscitation is unknown.
METHODS
Ancillary study to the MONITOR(NCT03256578) randomised controlled trial. Neonatal resuscitation leaders at two centres wore eye-tracking glasses, and visual attention (VA) patterns were compared between RFM-visible and RFM-masked groups.
RESULTS
14 resuscitations (6 RFM-visible, 8 RFM-masked) were analysed. The median total gaze duration on the RFM was significantly higher with a visible RFM (29% vs 1%, p<0.01), while median total gaze duration on other physical objects was significantly lower with a visible RFM (3% vs 8%, p=0.02). Median total gaze duration on the infant was lower with RFM visible, although not statistically significantly (29% vs 46%, p=0.05).
CONCLUSION
Providers' VA patterns differed during neonatal resuscitation when the RFM was visible, emphasising the importance of studying the impact of additional delivery room technology on providers' behaviour.",2020,"Median total gaze duration on the infant was lower with RFM visible, although not statistically significantly (29% vs 46%, p=0.05).
",['neonatal resuscitation'],['Provider visual attention'],"['median total gaze duration on other physical objects', 'Median total gaze duration', 'median total gaze duration on the RFM']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]",,0.061549,"Median total gaze duration on the infant was lower with RFM visible, although not statistically significantly (29% vs 46%, p=0.05).
","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Herrick', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA herrickh@email.chop.edu.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Weinberg', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cecarelli', 'Affiliation': 'Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Fishman', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Newman', 'Affiliation': ""Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'den Boer', 'Affiliation': 'Neonatology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Martherus', 'Affiliation': 'Neonatology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Trixie A', 'Initials': 'TA', 'LastName': 'Katz', 'Affiliation': 'Neonatology, Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Nadkarni', 'Affiliation': ""Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Arjan B', 'Initials': 'AB', 'LastName': 'Te Pas', 'Affiliation': 'Neonatology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Foglia', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2020-319291']
1165,32618165,"The use of ozone therapy for treatment of periodontal disease: a split-mouth, randomized, controlled clinical trial.","Periodontal treatment has the aim to reduce oral infection and prevent the progression of the disease. The potential benefits of new therapy with Ozonline® for periodontal treatment, include improved patient compliance and an easier access to periodontal pocket. The objective of this study was to explore the efficacy of Ozonline® in the treatment of chronic periodontitis in adult patients. A randomized controlled split-mouth study was carried out in ten patients (5 men and 5 women age 42-73 mean 55 ±7) with a diagnosis of chronic periodontitis. None of these patients received any surgical or non-surgical periodontal therapy and demonstrated radiographic evidence of moderate bone loss. The mouth has been divided into upper right and left quadrants. The upper and lower right quadrants were treated with ultrasonic scaler, the left quadrants with ultrasonic scaler with ozonated water (Ozonline®). 10 microbiological samples were collected from upper left quadrants and 10 from upper right quadrants from each patient. Microbiological samples were collected from the sites of the patients at baseline and at the 7th day. 20 localized chronic periodontitis sites were selected (10 in left quadrants and 10 in right quadrants). After the treatment with Ozonline®, a remarkable decrease in bacteria amount, both for some species and for the total count was observed in the left quadrants respect to right ones. Specifically, T. forsythia and T. denticola were eradicated whereas Total Bacteria Loading and Fusobacterium nucleatum showed a reduction of 38% and 55%, respect to right quadrants. Our study demonstrated the efficacy of the Ozonline® in the management of moderate to severe chronic periodontitis. .",2020,"After the treatment with Ozonline®, a remarkable decrease in bacteria amount, both for some species and for the total count was observed in the left quadrants respect to right ones.","['chronic periodontitis in adult patients', 'ten patients (5 men and 5 women age 42-73 mean 55 ±7) with a diagnosis of chronic periodontitis']","['ultrasonic scaler, the left quadrants with ultrasonic scaler with ozonated water (Ozonline®', 'Ozonline®', 'ozone therapy']","['total count', 'bacteria amount']","[{'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0183103', 'cui_str': 'Dental ultrasonic scaler'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C4727847', 'cui_str': 'Ozone therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",20.0,0.0173597,"After the treatment with Ozonline®, a remarkable decrease in bacteria amount, both for some species and for the total count was observed in the left quadrants respect to right ones.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Piva', 'Affiliation': 'Private Practice, Ferrara, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Avantaggiato', 'Affiliation': 'Private Practice, Ferrara, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Candotto', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences University of Milan, 20122 Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pellati', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicina, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Moreo', 'Affiliation': 'Department of Medicine and Surgery, Centre of Neuroscience of Milan, University of Milan-Bicocca, 20900 Milan, Italy.'}]",Journal of biological regulators and homeostatic agents,[]
1166,32627589,"Effectiveness of social media (Facebook), targeted mailing, and in-person solicitation for the recruitment of young adult in a diabetes self-management clinical trial.","BACKGROUND/AIMS
Research is needed to identify promising recruitment strategies to reach and engage diverse young adults in diabetes clinical research. The aim of this study was to examine the relative strengths and weaknesses of three recruitment strategies used in a diabetes self-management clinical trial: social media advertising (Facebook), targeted mailing, and in-person solicitation of clinic patients.
METHODS
Strategies were compared in terms of (1) cost-effectiveness (i.e. cost of recruitment/number of enrolled participants), (2) ability to yield participants who would not otherwise be reached by alternative strategies, and (3) likelihood of participants recruited through each strategy to adhere to study procedures. We further explored the appeal (overall and among age and gender subgroups) of social media advertisement features.
RESULTS
In-person recruitment of clinic patients was overall the most cost-effective strategy. However, differences in demographic, clinical, and psychosocial characteristics of participants recruited via different strategies suggest that the combination of these approaches yielded a more diverse sample than would any one strategy alone. Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies.
CONCLUSIONS
Ultimately, the utility of a recruitment strategy is defined by its ability to effectively attract people representative of the target population who are willing to enroll in and complete the study. Leveraging a variety of recruitment strategies appears to produce a more representative sample of young adults, including those who are less engaged in diabetes care.",2020,"Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies.
","['to yield participants who would not otherwise be reached by alternative strategies, and (3) likelihood of participants recruited through each strategy to adhere to study procedures']","['social media (Facebook), targeted mailing, and in-person solicitation']","['cost-effectiveness (i.e. cost of recruitment/number of enrolled participants), (2) ability']","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",3.0,0.147519,"Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies.
","[{'ForeName': 'Sarah-Jeanne', 'Initials': 'SJ', 'LastName': 'Salvy', 'Affiliation': 'Research Center for Health Equity, Cedars-Sinai Medical Center, West Hollywood, CA, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Carandang', 'Affiliation': 'University of California at San Diego, San Diego, CA, USA.'}, {'ForeName': 'Cheryl Lp', 'Initials': 'CL', 'LastName': 'Vigen', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Concha-Chavez', 'Affiliation': 'Northern Arizona University, Phoenix, AZ, USA.'}, {'ForeName': 'Paola A', 'Initials': 'PA', 'LastName': 'Sequeira', 'Affiliation': 'Los Angeles Department of Health Services, Los Angeles, CA, USA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Blanchard', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Diaz', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Pyatak', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520933362']
1167,32623343,"""Sushi roll"" technique for precise total tongue functional reconstruction using a pre-sutured femoral anterolateral myocutaneous flap.","OBJECTIVES
Reconstruction of the total tongue after cancer resection remains one of the challenges in head and neck surgery. Inadequate reconstruction after subtotal or total glossectomy defects leads to poor quality of life. The aim of this study was to explore an economical, practical and effective flap design for functional tongue reconstruction.
MATERIAL AND METHODS
Sixty patients were randomly divided into two groups, namely, a ""Sushi roll"" technique group (30 patients) and a conventional surgery group (30 patients). Then, the patients underwent total or subtotal tongue reconstruction. Swallowing function, speech intelligibility, cosmetic results, and quality of life were assessed with the appropriate scales. Outcomes were analysed, and a p-value <0.05 was considered significant.
RESULTS
The perioperative recovery of the ""Sushi roll"" group was superior to that of the conventional group. Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
CONCLUSION
The innovative ""Sushi roll"" anterolateral thigh myocutaneous flap approach for total tongue reconstruction creates a free neotongue tip with adequate volume and protuberance and causes minimal damage to the donor site, producing acceptable swallowing function and speech intelligibility.",2020,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","['head and neck surgery', 'Sixty patients']","['Sushi roll"" technique group', 'conventional surgery', 'Sushi roll"" technique', 'subtotal tongue reconstruction']","['speech intelligibility', 'swallowing function', 'Swallowing function, speech intelligibility, cosmetic results, and quality of life', 'perioperative recovery', 'cosmetic results']","[{'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0399188', 'cui_str': 'Tongue reconstruction'}]","[{'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0201308,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: drzhouxi0504@csu.edu.cn.'}, {'ForeName': 'Zhi-Jing', 'Initials': 'ZJ', 'LastName': 'He', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yu-Xiong', 'Initials': 'YX', 'LastName': 'Su', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, Faculty of Dentistry, the University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhao Jian', 'Initials': 'ZJ', 'LastName': 'Gong', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Han Jiang', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104866']
1168,32628922,"Incidence and Outcome of Uveitic Glaucoma in Eyes With Intermediate, Posterior, or Panuveitis Followed up to 10 Years After Randomization to Fluocinolone Acetonide Implant or Systemic Therapy.","PURPOSE
To evaluate long-term risk and outcomes of glaucoma in eyes with intermediate, posterior, and panuveitis managed with systemic or fluocinolone acetonide (0.59 mg, ""implant"") therapy.
DESIGN
Prospective Follow-up of the Multicenter Uveitis Steroid Treatment (MUST) Clinical Trial Cohort.
METHODS
Patients with intermediate, posterior, or panuveitis randomized to implant or systemic therapy (corticosteroid plus immunosuppression in >90%) were followed prospectively for glaucoma incidence and outcome.
RESULTS
Among 405 uveitic at-risk eyes of 232 patients (median follow-up = 6.9 years), 40% (79/196) of eyes assigned and treated with implant and 8% (17/209) of eyes assigned and treated with systemic therapy (censoring eyes receiving an implant on implantation) developed glaucoma (hazard ratio [HR] = 5.9, 95% confidence interval [CI] 3.2, 10.8; P < .001). Adjustment for intraocular pressure (IOP) elevation during follow-up only partially mitigated the association of implant treatment with glaucoma incidence: HR = 3.1 (95% CI 1.6, 6.0); P = .001. Among 112 eyes of 83 patients developing glaucoma, the 5-year cumulative incidence following diagnosis of sustained (2 or more consecutive visits) worsening of mean deviation by ≥6 dB was 20% (95% CI 12%, 33%); 5-year cumulative incidence of sustained worsening of cup-to-disc ratio by ≥0.2 was 26% (95% CI 17%, 39%).
CONCLUSIONS
The implant has substantially higher risk of glaucoma than systemic therapy, a difference not entirely explained by posttreatment IOP elevation. Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management, some glaucoma worsened. Uveitis cases should be monitored carefully for IOP elevation and glaucoma indefinitely.",2020,"Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management some glaucoma worsened.","['eyes with intermediate, posterior, and panuveitis managed with systemic or', '112 eyes of 83 patients developing glaucoma', 'Multicenter Uveitis Steroid Treatment (MUST', ' Patients with intermediate, posterior or panuveitis randomized to', 'eyes with intermediate, posterior or panuveitis followed up to 10 years after randomization to']","['systemic therapy', 'implant or systemic therapy (corticosteroid plus immunosuppression', 'fluocinolone acetonide', 'fluocinolone acetonide implant or systemic therapy']","['IOP elevation', 'sustained worsening of cup-to-disc ratio', 'uveitic glaucoma']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0030343', 'cui_str': 'Panuveitis'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0016298', 'cui_str': 'fluocinolone acetonide'}]","[{'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0423471', 'cui_str': 'Optic cup/disc ratio'}, {'cui': 'C1281939', 'cui_str': 'Uveitic glaucoma'}]",83.0,0.167216,"Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management some glaucoma worsened.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Kempen', 'Affiliation': 'Department of Ophthalmology, Massachusetts Eye and Ear, Boston, Massachusetts, USA; Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts, USA; The MyungSung Christian Medical Center (MCM) Eye Unit, MCM General Hospital and MyungSung Medical School, Addis Ababa, Ethiopia. Electronic address: john_kempen@meei.harvard.edu.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Van Natta', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Friedman', 'Affiliation': 'Department of Ophthalmology, Massachusetts Eye and Ear, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Altaweel', 'Affiliation': 'Fundus Photograph Reading Center, Department of Ophthalmology and Visual Sciences, University of Wisconsin, Madison, Wisconsin, USA.'}, {'ForeName': 'Husam', 'Initials': 'H', 'LastName': 'Ansari', 'Affiliation': 'Ophthalmology Consultants of Boston, Boston, Massachusetts, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dunn', 'Affiliation': 'Mid-Atlantic Retina, Philadelphia, Pennsylvania, USA; The Wills Eye Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Elner', 'Affiliation': 'The Kellogg Eye Center, Department of Ophthalmology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Janet T', 'Initials': 'JT', 'LastName': 'Holbrook', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Lyndell L', 'Initials': 'LL', 'LastName': 'Lim', 'Affiliation': 'The Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Biostatistics, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Jabs', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; The Johns Hopkins University School of Medicine Wilmer Eye Institute, Baltimore, Maryland, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.038']
1169,32630541,Brief Psychological Intervention Through Mobile App and Conference Calls for the Prevention of Depression in Non-Professional Caregivers: A Pilot Study.,"Despite its potential, no intervention aimed at non-professional caregivers administered through a smartphone app has been proven to prevent depression. The objective of this pilot study was to evaluate the efficacy and feasibility of an indicated depression-prevention intervention for non-professional caregivers administered through an app with the addition of conference-call contact. The intervention was administered to 31 caregivers (Mean age = 54.0 years, 93.5% women). An independent evaluation determined the incidence of depression, depressive symptoms, risk of developing depression, and the variables in the theoretical model (positive environmental reinforcement, negative automatic thoughts) at the pre-intervention and post-intervention, as well as the one- and three-month follow-ups. The incidence of depression at 3 months of follow-up was 6.5%. There was a significant reduction in depressive symptoms ( p < 0.001) and in the risk of developing depression ( p < 0.001) at the post-intervention and at the one- and three-month follow-ups. The model's variables improved significantly after the intervention and were associated with post-intervention depressive symptoms. The intervention was more effective in caregivers who had a lower level of depressive symptoms at the pre-intervention. Adherence and satisfaction with the intervention were high. The results encourage future research using a randomized controlled clinical trial.",2020,There was a significant reduction in depressive symptoms ( p < 0.001) and in the risk of developing depression ( p < 0.001) at the post-intervention and at the one- and three-month follow-ups.,"['Non-Professional Caregivers', '31 caregivers (Mean age = 54.0 years, 93.5% women', 'non-professional caregivers administered through an app with the addition of conference-call contact']","['depression-prevention intervention', 'Brief Psychological Intervention Through Mobile App and Conference Calls']","['incidence of depression, depressive symptoms, risk of developing depression', 'Adherence and satisfaction', 'depressive symptoms', 'incidence of depression', 'efficacy and feasibility', 'risk of developing depression']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0575702,There was a significant reduction in depressive symptoms ( p < 0.001) and in the risk of developing depression ( p < 0.001) at the post-intervention and at the one- and three-month follow-ups.,"[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Otero', 'Affiliation': 'Department of Psychology, University of A Coruña, 15071 A Coruña, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Hita', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}, {'ForeName': 'Ángela J', 'Initials': 'ÁJ', 'LastName': 'Torres', 'Affiliation': 'Department of Psychiatry, Radiology and Public Health, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}, {'ForeName': 'Fernando L', 'Initials': 'FL', 'LastName': 'Vázquez', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124578']
1170,32635883,Preconditioning Effect of Remifentanil Versus Fentanyl in Prevalence of Early Graft Dysfunction in Patients After Liver Transplant: A Randomized Clinical Trial.,"OBJECTIVES
One of the most prevalent complications of orthotopic liver transplant is primary graft dysfunction. Recent studies have shown the preconditioning effect of remifentanil on animal livers but not human livers. Here, we compared the preconditioning effects of remifentanil and fentanyl in orthotopic liver transplant in human patients.
MATERIALS AND METHODS
In this double-blind clinical trial, 100 patients who underwent liver transplant from deceased donors were randomly allocated into 2 groups. Patients in the remifentanil group received remifentanil infusion, and those in the fentanyl group received fentanyl infusion during maintenance of anesthesia. Serum aminotransferase levels, prothrombin time (international normalized ratio), partial thrombin time, arterial blood gas levels, and renal function tests were evaluated over 7 days posttransplant. Intensive care unit stay and hospitalization were also recorded.
RESULTS
The median peak alanine aminotransferase level during 7 days after transplant was 2100 U/L (interquartile range, 1230-3220) in the remifentanil group and 3815 U/L (interquartile range, 2385-5675) in the fentanyl group (P = .048). Metabolic acidosis, renal state, prothrombin time (international normalized ratio), and partial thrombin time were similar in both groups (P > .05). Durations of stay in the intensive care unit and hospital were not significantly different between the 2 groups (P = .75 and P = .23, respectively). Overall, the clinical outcomes were similar in the remifentanil and fentanyl groups (P > .05).
CONCLUSIONS
We found that remifentanil and fentanyl were not different with regard to their preconditioning effects and graft protection in orthotopic liver transplant recipients.",2020,"Durations of stay in the intensive care unit and hospital were not significantly different between the 2 groups (P = .75 and P = .23, respectively).","['100 patients who underwent liver transplant from deceased donors', 'Patients', 'After Liver Transplant', 'orthotopic liver transplant in human patients', 'orthotopic liver transplant recipients']","['Remifentanil Versus Fentanyl', 'remifentanil infusion', 'fentanyl infusion', 'remifentanil', 'remifentanil and fentanyl']","['Metabolic acidosis, renal state, prothrombin time (international normalized ratio), and partial thrombin time', 'median peak alanine aminotransferase level', 'Intensive care unit stay and hospitalization', 'Durations of stay in the intensive care unit and hospital', 'Serum aminotransferase levels, prothrombin time (international normalized ratio), partial thrombin time, arterial blood gas levels, and renal function tests', 'Prevalence of Early Graft Dysfunction']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0400447', 'cui_str': 'Orthotopic liver transplant'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0677634', 'cui_str': 'Reptilase time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1167870', 'cui_str': 'Transplant dysfunction'}]",100.0,0.0598673,"Durations of stay in the intensive care unit and hospital were not significantly different between the 2 groups (P = .75 and P = .23, respectively).","[{'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Jowkar', 'Affiliation': 'From the Department of Anesthesia, Nemazee Hospital, Shiraz, Fars, Iran.'}, {'ForeName': 'Mohammad Bagher', 'Initials': 'MB', 'LastName': 'Khosravi', 'Affiliation': ''}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Sahmeddini', 'Affiliation': ''}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Eghbal', 'Affiliation': ''}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Samadi', 'Affiliation': ''}]",Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation,['10.6002/ect.2019.0014']
1171,32641226,Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.,"The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in the PARADIGM-HF study had New York Heart Association (NYHA) functional class IV symptoms. Accordingly, data that informed the use of S/V among patients with advanced HF were limited. The LIFE (LCZ696 in Hospitalized Advanced Heart Failure) study was a 24-week prospective, multicenter, double-blinded, double-dummy, active comparator trial that compared the safety, efficacy, and tolerability of S/V with those of valsartan in patients with advanced HFrEF. The trial planned to randomize 400 patients ≥18 years of age with advanced HF, defined as an EF ≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/ml), and ≥1 objective finding of advanced HF. Following a 3- to 7-day open label run-in period with S/V (24 mg/26 mg twice daily), patients were randomized 1:1 to S/V titrated to 97 mg/103 mg twice daily versus 160 mg of V twice daily. The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints included clinical outcomes and safety and tolerability. Because of the COVID-19 pandemic, enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis consists of the first 335 randomized patients whose clinical follow-up examination results were not severely impacted by COVID-19. (Entresto [LCZ696] in Advanced Heart Failure [LIFE STUDY] [HFN-LIFE]; NCT02816736).",2020,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"['400 patients\xa0≥18 years of age with advanced HF, defined as an EF\xa0≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP]\xa0≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP]\xa0≥800 pg/ml), and\xa0≥1 objective finding of advanced HF', 'patients with advanced HF', 'Failure With Reduced Ejection Fraction', 'Heart\xa0Failure', 'Advanced Heart\xa0Failure [LIFE STUDY', 'HF patients with a reduced ejection fraction (HFrEF', 'Advanced Heart', 'patients with advanced HFrEF']","['Entresto [LCZ696', 'valsartan', 'Angiotensin II Receptor Blocker Neprilysin Inhibitor', 'Angiotensin-Converting Enzyme Inhibitor', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'LIFE (LCZ696']","['mortality and heart failure (HF) hospitalization', 'proportional change from baseline in the area under the curve for NT-proBNP levels', 'Global Mortality and Morbidity', 'safety, efficacy, and tolerability', 'clinical outcomes and safety and tolerability']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4033616', 'cui_str': 'Entresto'}, {'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",335.0,0.331951,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri. Electronic address: dmann@wustl.edu.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Vader', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Mahr', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Selma F', 'Initials': 'SF', 'LastName': 'Mohammed', 'Affiliation': 'MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Nisha A', 'Initials': 'NA', 'LastName': 'Gilotra', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eiran Z', 'Initials': 'EZ', 'LastName': 'Gorodeski', 'Affiliation': 'Department of Medicine, Harrington Heart and Vascular Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Baltimore, Maryland.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2020.05.005']
1172,32646746,Physiological factors determining downhill vs uphill running endurance performance.,"OBJECTIVES
Recent studies investigated the determinants of trail running performance (i.e., combining uphill (UR) and downhill running sections (DR)), while the possible specific physiological factors specifically determining UR vs DR performances (i.e., isolating UR and DR) remain presently unknown. This study aims to determine the cardiorespiratory responses to outdoor DR vs UR time-trial and explore the determinants of DR and UR performance in highly trained runners.
DESIGN
Randomized controlled trial.
METHODS
Ten male highly-trained endurance athletes completed 5-km DR and UR time-trials (average grade: ±8%) and were tested for maximal oxygen uptake, lower limb extensor maximal strength, local muscle endurance, leg musculotendinous stiffness, vertical jump ability, explosivity/agility and sprint velocity. Predictors of DR and UR performance were investigated using correlation and commonality regression analyses.
RESULTS
Running velocity was higher in DR vs UR time-trial (20.4±1.0 vs 12.0±0.5km·h -1 , p<0.05) with similar average heart rate (95±2% vs 94±2% maximal heart rate; p>0.05) despite lower average V̇O 2 (85±8% vs 89±7% V̇O 2max ; p<0.05). Velocity at V̇O 2max (vV̇O 2max ) body mass index (BMI) and maximal extensor strength were significant predictors of UR performance (r 2 =0.94) whereas vV̇O 2max , leg musculotendinous stiffness and maximal extensor strength were significant predictors of DR performance (r 2 =0.84).
CONCLUSIONS
Five-km UR and DR running performances are both well explained by three independent predictors. If two predictors are shared between UR and DR performances (vV̇O 2max and maximal strength), their relative contribution is different and, importantly, the third predictor appears very specific to the exercise modality (BMI for UR vs leg musculotendinous stiffness for DR).",2020,"(vV̇O 2max ) body mass index (BMI) and maximal extensor strength were significant predictors of UR performance (r 2 =0.94) whereas vV̇O 2max , leg musculotendinous stiffness and maximal extensor strength were significant predictors of DR performance (r 2 =0.84).
","['Ten male highly-trained endurance athletes completed 5-km DR and UR time-trials (average grade: ±8%) and were tested for', 'highly trained runners']",['combining uphill (UR) and downhill running sections (DR'],"['UR and DR running performances', 'Running velocity', 'vV̇O 2max ) body mass index (BMI) and maximal extensor strength', 'vV̇O 2max , leg musculotendinous stiffness and maximal extensor strength', 'UR and DR performances (vV̇O 2max and maximal strength', 'Velocity at V̇O 2max', 'average heart rate', 'UR performance', 'DR and UR performance', 'maximal oxygen uptake, lower limb extensor maximal strength, local muscle endurance, leg musculotendinous stiffness, vertical jump ability, explosivity/agility and sprint velocity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035953', 'cui_str': 'Running'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",10.0,0.0353636,"(vV̇O 2max ) body mass index (BMI) and maximal extensor strength were significant predictors of UR performance (r 2 =0.94) whereas vV̇O 2max , leg musculotendinous stiffness and maximal extensor strength were significant predictors of DR performance (r 2 =0.84).
","[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Lemire', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University of Strasbourg, Faculty of Sport Sciences, France. Electronic address: marcel.lemire@unistra.fr.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Hureau', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University of Strasbourg, Faculty of Sport Sciences, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Favret', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University of Strasbourg, Faculty of Sport Sciences, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Geny', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University Hospitals of Strasbourg, Physiology and Functional Explorations Department, Civil Hospital, France.'}, {'ForeName': 'Blah Y L', 'Initials': 'BYL', 'LastName': 'Kouassi', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University of Strasbourg, Faculty of Sport Sciences, France.'}, {'ForeName': 'Mourad', 'Initials': 'M', 'LastName': 'Boukhari', 'Affiliation': 'University of Strasbourg, Faculty of Sport Sciences, France.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Lonsdorfer', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University Hospitals of Strasbourg, Physiology and Functional Explorations Department, Civil Hospital, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Remetter', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University Hospitals of Strasbourg, Physiology and Functional Explorations Department, Civil Hospital, France.'}, {'ForeName': 'Stéphane P', 'Initials': 'SP', 'LastName': 'Dufour', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Translational Medicine Federation (FMTS), UR 3072, France; University of Strasbourg, Faculty of Sport Sciences, France.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.06.004']
1173,32653248,Modifying bowling kinematics in cricket pace bowlers with exercise-based injury prevention: A cluster-randomised controlled trial.,"OBJECTIVES
Undesirable bowling kinematics can increase the risk of low back injury. This study investigated if an exercise-based injury prevention program (IPP) could modify bowling kinematics in community-level adolescent pace bowlers.
DESIGN
Cluster-randomised controlled trial.
METHODS
Pace bowlers from eight cricket organisations were cluster-randomised into an intervention or control group. At baseline and follow-up sessions biomechanical bowling data were collected. Between sessions, the intervention group completed an eight-week IPP while the control continued their normal cricket activity. Treatment effects (95% CI) were estimated with linear mixed models.
RESULTS
There were significant treatment effects favouring the intervention group for shoulder counter-rotation (-3.8°; -7.2° to -0.3°) and lateral trunk flexion relative to the pelvis (-2.2°; -4.0° to -0.5°). Shoulder counter-rotation also increased in the control group by 2.2° (Cohen's d=0.22). There were no effects of the intervention on: lateral trunk flexion at front foot contact (FFC) (1.2°; -2.5° to 4.8°), lateral trunk flexion at ball release (BR) (-0.5°; -3.0° to 2.0°), pelvis rotation at FFC (0.9°; -4.0° to 2.2°), pelvis rotation at BR (-1.1°; -5.7° to 3.6°), front hip angle at FFC (1.6°; -3.6° to 6.7°), front hip angle at BR (-1.6°; -5.0° to 1.9°), front knee angle at FFC (-1.1°; -4.5° to 2.3°), front knee angle at BR (1.7°; -5.6° to 9.1°), or ball velocity (1.1kmh -1 ; -7.5kmh -1 to 9.7kmh -1 ).
CONCLUSIONS
The IPP maintained shoulder counter-rotation and lateral trunk flexion relative to the pelvis in the intervention group and this could attenuate injury risk. No treatment effects were observed for lower-limb kinematics.",2020,There were significant treatment effects favouring the intervention group for shoulder counter-rotation (-3.8°; -7.2° to -0.3°) and lateral trunk flexion relative to the pelvis (-2.2°; -4.0° to -0.5°).,['Pace bowlers from eight cricket organisations were cluster-randomised into an intervention or control group'],"['exercise-based injury prevention', 'exercise-based injury prevention program (IPP']","['lateral trunk flexion relative to the pelvis', 'Shoulder counter-rotation', 'lower-limb kinematics', 'pelvis rotation at FFC', 'pelvis rotation at BR ', 'lateral trunk flexion at ball release (BR', 'shoulder counter-rotation', 'lateral trunk flexion at front foot contact (FFC']","[{'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0018288', 'cui_str': 'Cricket'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",,0.0439172,There were significant treatment effects favouring the intervention group for shoulder counter-rotation (-3.8°; -7.2° to -0.3°) and lateral trunk flexion relative to the pelvis (-2.2°; -4.0° to -0.5°).,"[{'ForeName': 'Mitchell R L', 'Initials': 'MRL', 'LastName': 'Forrest', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Perth, WA, Australia; Murdoch Applied Sports Science Laboratory, Murdoch University, Perth, WA, Australia.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Hebert', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Perth, WA, Australia; Faculty of Kinesiology, University of New Brunswick, Fredericton, NB, Canada.'}, {'ForeName': 'Brendan R', 'Initials': 'BR', 'LastName': 'Scott', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Perth, WA, Australia; Murdoch Applied Sports Science Laboratory, Murdoch University, Perth, WA, Australia.'}, {'ForeName': 'Alasdair R', 'Initials': 'AR', 'LastName': 'Dempsey', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Perth, WA, Australia; Murdoch Applied Sports Science Laboratory, Murdoch University, Perth, WA, Australia.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.06.014']
1174,32655024,"The Effects of Nano-curcumin on Metabolic Status in Patients With Diabetes on Hemodialysis, a Randomized, Double Blind, Placebo-controlled Trial.","INTRODUCTION
This study evaluated the effects of nano-curcumin intake on metabolic status in patients with diabetes on hemodialysis (HD).
METHODS
This randomized, double-blind, placebo-controlled clinical trial was performed on 60 patients with diabetes on HD. Participants were randomly divided into two groups to take either 80 mg/d nano-curcumin (n = 30) or placebo (n = 30) for 12 weeks.
RESULTS
Nano-curcumin significantly decreased fasting plasma glucose (β = -19.68 mg/dL, 95% CI: -33.48 to -5.88; P < .05) and serum insulin levels (β = -1.70 μIU/mL, 95% CI: -2.96 to -0.44; P < .05) when compared with patients who received placebo. Nanocurcumin treatment was associated with a significant reduction in triglycerides (β = -16.13 mg/dL, 95% CI: -31.51 to -0.75; P < .05), VLDL-cholesterol (β = -3.22 mg/dL, 95% CI: -6.30 to -0.15; P < .05), total cholesterol (β = -17.83 mg/dL, 95% CI: -29.22 to -6.45; P < .05), LDL-cholesterol (β = -15.20 mg/dL, 95% CI: -25.53 to -4.87; P < .05), and total-cholesterol/HDL-cholesterol ratio (β = -1.15, 95% CI: -0.2.10 to -0.21; P < .05) when compared with the placebo. Nanocurcumin also resulted in a significant reduction of serum high sensitivity CRP (β = -0.78 mg/L, 95% CI: -1.41 to -0.15; P < .05), and plasma malondialdehyde (β = -0.25 μmol/L, 95% CI: -0.45 to -0.04; P < .05); but also with a significant increase in plasma total antioxidant capacity (β = 52.43 mmol/L; 95% CI: 4.52 to 100.35; P < .05) and total nitrite levels (β = 3.62 μmol/L, 95% CI: 2.17 to 5.08; P < .001) when compared with placebo.
CONCLUSION
Nano-curcumin intake for 12 weeks had beneficial effects on metabolic profile in patients with diabetes on HD.",2020,"RESULTS
Nano-curcumin significantly decreased fasting plasma glucose (β = -19.68 mg/dL, 95% CI: -33.48 to -5.88; P < .05) and serum insulin levels (β = -1.70 μIU/mL, 95% CI: -2.96 to -0.44; P","['patients with diabetes on HD', '60 patients with diabetes on HD', 'Patients With Diabetes on Hemodialysis', 'patients with diabetes on hemodialysis (HD']","['80 mg/d nano-curcumin', 'Placebo', 'Nanocurcumin', 'Nano-curcumin', 'Nano-curcumin intake', 'nano-curcumin intake', 'placebo']","['plasma total antioxidant capacity', 'triglycerides ', 'total nitrite levels', 'total cholesterol', 'metabolic status', 'VLDL-cholesterol', 'Metabolic Status', 'total-cholesterol/HDL-cholesterol ratio', 'plasma malondialdehyde', 'LDL-cholesterol', 'serum high sensitivity CRP', 'metabolic profile', 'serum insulin levels', 'fasting plasma glucose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0580333', 'cui_str': 'Urine nitrite'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",60.0,0.295549,"RESULTS
Nano-curcumin significantly decreased fasting plasma glucose (β = -19.68 mg/dL, 95% CI: -33.48 to -5.88; P < .05) and serum insulin levels (β = -1.70 μIU/mL, 95% CI: -2.96 to -0.44; P","[{'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Shafabakhsh', 'Affiliation': ''}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': ''}, {'ForeName': 'Zeljko', 'Initials': 'Z', 'LastName': 'Reiner', 'Affiliation': ''}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Soleimani', 'Affiliation': ''}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': ''}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. r.shafabakhsh@gmail.com.'}]",Iranian journal of kidney diseases,[]
1175,31705570,Two-dimensional speckle-tracking strain detects subclinical cardiotoxicity in older patients treated for acute myeloid leukemia.,"BACKGROUND
Patients with acute myeloid leukemia (AML) are surviving longer. There are no data on changes in myocardial mechanics from standard of care low-dose anthracycline-based induction chemotherapy in older patients with AML. The aim of this study was to demonstrate the potential utility of strain imaging in detecting early changes in left ventricular function in this patient population after induction chemotherapy.
METHODS
Thirty two patients enrolled in the ECOG-ACRIN E2906 study (cytarabine and daunorubicin vs clofarabine [Genzyme/Sanofi]) from 2011 to 2014 were evaluated retrospectively. Two-dimensional transthoracic echocardiography (TTE) imaging with Doppler and two-dimensional speckle-tracking echocardiography (2DSTE) using EchoInsight software (Epsilon imaging) were performed before and after induction chemotherapy.
RESULTS
Eighteen patients received cytarabine and daunorubicin (7 + 3) and 14 received clofarabine. The clofarabine group was older than the 7 + 3 cohort (67.8 ± 4.0 vs 63.7 ± 3.8, P = .007). There were no other significant differences in cardiac risk factors between groups. The 7 + 3 group had a decrease in average peak systolic global longitudinal (-19.1 ± 2.8 to -17.2 ± 3.0, P = .01) and circumferential strain (-29.4 ± 6.3 to -23.9 ± 4.3, P = .011). These changes were not demonstrated in the clofarabine group and were not associated with a decline in left ventricular ejection fraction (LVEF).
CONCLUSIONS
In older AML patients, standard cytarabine and daunorubicin chemotherapy causes early changes in global longitudinal and circumferential strain not seen with clofarabine therapy. These findings demonstrate subclinical left ventricular dysfunction after exposure to low cumulative doses of anthracycline-based induction chemotherapy and may help us better identify those patients at risk for adverse long-term cardiovascular outcomes.",2019,"These changes were not demonstrated in the clofarabine group and were not associated with a decline in left ventricular ejection fraction (LVEF).
","['Patients with acute myeloid leukemia (AML', 'older patients with AML', 'two patients enrolled in the ECOG-ACRIN E2906 study', 'patient population after induction chemotherapy', 'Thirty', 'older patients treated for acute myeloid leukemia']","['anthracycline-based induction chemotherapy', 'cytarabine and daunorubicin', 'Two-dimensional speckle-tracking strain', 'clofarabine', 'Two-dimensional transthoracic echocardiography (TTE) imaging with Doppler and two-dimensional speckle-tracking echocardiography (2DSTE) using EchoInsight software (Epsilon imaging', 'cytarabine and daunorubicin vs clofarabine [Genzyme/Sanofi', 'standard cytarabine and daunorubicin chemotherapy', 'clofarabine therapy', 'strain imaging']","['myocardial mechanics', 'average peak systolic global longitudinal', 'circumferential strain', 'cardiac risk factors', 'left ventricular ejection fraction (LVEF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}]","[{'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0092777', 'cui_str': 'clofarabine'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0113456', 'cui_str': ""di(1,N(6)-ethenoadenosine)-5',5'''-P(1),P(4)-tetraphosphate""}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}]",32.0,0.0385403,"These changes were not demonstrated in the clofarabine group and were not associated with a decline in left ventricular ejection fraction (LVEF).
","[{'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Cascino', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Woo Bin', 'Initials': 'WB', 'LastName': 'Voss', 'Affiliation': 'Department of Cardiology, North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Canaani', 'Affiliation': 'Hematology Division, Chaim Sheba Medical Center, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Furiasse', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Rademaker', 'Affiliation': 'Department of Preventative Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Ky', 'Affiliation': 'Division of Cardiovascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Selina', 'Initials': 'S', 'LastName': 'Luger', 'Affiliation': 'Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Altman', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Foran', 'Affiliation': 'Division of Hematology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Litzow', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Tallman', 'Affiliation': 'Division of Hematologic Oncology, Sloan Kettering Memorial Cancer Center, New York, New York.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Rigolin', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Nausheen', 'Initials': 'N', 'LastName': 'Akhter', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}]","Echocardiography (Mount Kisco, N.Y.)",['10.1111/echo.14518']
1176,32666576,Clinical and cost effectiveness of a multi-professional medication reviews in care homes (CAREMED).,"OBJECTIVES
With 70% of care home residents experiencing a medication error every day in the UK, better multi-professional working between medical practitioners, pharmacists and care homes was recommended. The aim of this study was to determine the effectiveness (falls reduction) and cost-effectiveness, of a multi-professional medication review (MPMR) service in care homes for older people.
METHOD
A total of care homes in the East of England were cluster randomised to 'usual care' or two multi-professional (General practitioner, clinical pharmacist and care homes staff) medication reviews during the 12-month trial period. Target recruitment was 900 residents with 10% assumed loss to follow-up. Co-primary outcome measures were number of falls and potentially inappropriate prescribing assessed by the Screening Tool of Older Persons Prescriptions.
KEY FINDINGS
A total of 826 care home residents were recruited with 324 lost to follow-up for at least one primary outcome measure. The mean number of falls per resident per annum was 3.3 for intervention and 3.0 for control (P = 0.947). Each resident was found to be prescribed 0.69 (intervention) and 0.85 (control) potentially inappropriate medicines after 12 months (P = 0.046). No significant difference identified in emergency hospital admissions or deaths. Estimated unadjusted incremental mean cost per resident was £374.26 higher in the intervention group.
CONCLUSIONS
In line with other medication review based interventions in care homes, two MPMRs improved medication appropriateness but failed to demonstrate improvements in clinical outcomes. From a health system perspective costs where estimated to increase overall and therefore a different model of medicines management is required.",2020,Each resident was found to be prescribed 0.69 (intervention) and 0.85 (control) potentially inappropriate medicines after 12 months (P = 0.046).,"['826 care home residents were recruited with 324 lost to follow-up for at least one primary outcome measure', '900 residents with 10% assumed loss to follow-up', 'care homes for older people', ""A total of care homes in the East of England were cluster randomised to 'usual care' or two multi-professional (General practitioner, clinical pharmacist and care homes staff) medication"", 'With 70% of care home residents experiencing a medication error every day in the UK, better multi-professional working between medical practitioners, pharmacists and care homes']","['multi-professional medication review (MPMR) service', 'multi-professional medication']","['mean number of falls per resident per annum', 'effectiveness (falls reduction) and cost-effectiveness', 'emergency hospital admissions or deaths', 'number of falls and potentially inappropriate prescribing assessed by the Screening Tool of Older Persons Prescriptions']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C1449564', 'cui_str': 'Clinical pharmacist'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1306754', 'cui_str': 'Medical practitioner'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0184673', 'cui_str': 'Emergency hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2936303', 'cui_str': 'Inappropriate Prescribing'}, {'cui': 'C4305312', 'cui_str': ""STOPP - Screening Tool of Older Person's Prescriptions""}]",900.0,0.0886087,Each resident was found to be prescribed 0.69 (intervention) and 0.85 (control) potentially inappropriate medicines after 12 months (P = 0.046).,"[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Desborough', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norfolk, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norfolk, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Houghton', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norfolk, UK.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Sach', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norfolk, UK.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Shaw', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Viveca', 'Initials': 'V', 'LastName': 'Kirthisingha', 'Affiliation': 'Cambridge and Peterborough NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Holland', 'Affiliation': 'Leicester Medical School, George Davies Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Wright', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norfolk, UK.'}]",The International journal of pharmacy practice,['10.1111/ijpp.12656']
1177,32673573,"Comparison of Surgical Drain Placement With Use of Kinesiologic Tape on Postoperative Pain, Swelling, and Trismus in Impacted Mandibular Third Molar Surgery.","PURPOSE
The aim of this prospective study was to compare the effects of a surgical tube drain with kinesiologic tape (KT) application on postoperative complications such as trismus, swelling, and pain after impacted third molar surgery.
PATIENTS AND METHODS
This single-center, randomized study included 90 patients divided into 3 groups. After impacted third molar removal, 30 patients were treated with a tube drain (drain group), 30 patients were treated with KT application (KT group), and 30 patients were treated with a routine surgical operation and no extra procedure (control group).
RESULTS
A total of 29 male and 61 female patients were included. Mouth opening was greatest in the drain group over a period of 7 days. Patients in the control group had more pain than those in the drain and KT groups. No statistically significant difference was found in terms of pain and swelling between the drain and KT groups over the 7-day period of the study. The tube drain was found to improve patients' quality-of-life compared with the KT and control groups.
CONCLUSIONS
Although the effects of a tube drain and KT in terms of pain and swelling were similar, the tube drain was more effective in reducing postoperative complications.",2020,No statistically significant difference was found in terms of pain and swelling between the drain and KT groups over the 7-day period of the study.,"['90 patients divided into 3 groups', 'A total of 29 male and 61 female patients were included']","['Surgical Drain Placement', 'Kinesiologic Tape', 'tube drain and KT', 'KT application', 'surgical tube drain with kinesiologic tape (KT) application', 'tube drain', 'routine surgical operation and no extra procedure (control group']","['Postoperative Pain, Swelling, and Trismus', ""patients' quality of life"", 'postoperative complications such as trismus, swelling, and pain', 'pain and swelling', 'postoperative complications', 'pain', 'Mouth opening']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2607832', 'cui_str': 'Surgical drain'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}]",90.0,0.0266718,No statistically significant difference was found in terms of pain and swelling between the drain and KT groups over the 7-day period of the study.,"[{'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Menziletoglu', 'Affiliation': 'Assistant Professor, Faculty of Dentistry, Oral and Maxillofacial Surgery, Necmettin Erbakan University, Konya, Turkey. Electronic address: drdilekmenziletoglu@gmail.com.'}, {'ForeName': 'Arif Yigit', 'Initials': 'AY', 'LastName': 'Guler', 'Affiliation': 'Research Assistant, Faculty of Dentistry, Oral and Maxillofacial Surgery, Necmettin Erbakan University, Konya, Turkey.'}, {'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Basturk', 'Affiliation': 'Research Assistant, Faculty of Dentistry, Oral and Maxillofacial Surgery, Necmettin Erbakan University, Konya, Turkey.'}, {'ForeName': 'Bozkurt Kubilay', 'Initials': 'BK', 'LastName': 'Isik', 'Affiliation': 'Professor and Department Head, Faculty of Dentistry, Oral and Maxillofacial Surgery, Necmettin Erbakan University, Konya, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.06.023']
1178,33065552,Effect of ticagrelor versus clopidogrel on platelet reactivity measured by thrombelastography in patients with minor stroke or TIA.,"In this study, we tested the effect of ticagrelor versus clopidogrel on platelet reactivity in patients with minor stroke or transient ischemic attack (TIA). A pre-specified subgroup analysis of a randomized controlled trial was conducted. Platelet reactivity was assessed by thrombelastography (TEG) platelet mapping. Patients were divided into carriers and non-carriers according to the carrier status of CYP2C19 loss-of-function (LOF) alleles. The primary outcome was the proportion of patients with high on-treatment platelet reactivity (HOPR) (defined as maximum amplitude induced by adenosine diphosphate > 47mm) at 90±7 days. Clinical outcomes within 90±7 days were followed up. Among 339 patients, 170 were randomized to ticagrelor/aspirin and 169 to clopidogrel/aspirin. Compared with clopidogrel/aspirin, the proportion of HOPR at 90±7 days in ticagrelor/aspirin was significantly lower (12.2% versus 30.0%, P < 0.001). Ticagrelor/aspirin had a lower proportion of HOPR among carriers (11.0% versus 35.6%, P < 0.001), but not among non-carriers (13.5% versus 22.4%, P = 0.17). Ticagrelor was superior to clopidogrel in inhibiting platelet reactivity measured by TEG platelet mapping among patients with acute minor stroke or TIA, particularly in carriers of the CYP2C19 LOF alleles. Large randomised controlled trials are needed to confirm our findings.",2020,"Ticagrelor was superior to clopidogrel in inhibiting platelet reactivity measured by TEG platelet mapping among patients with acute minor stroke or TIA, particularly in carriers of the CYP2C19 LOF alleles.","['patients with minor stroke or TIA', 'patients with minor stroke or transient ischemic attack (TIA', 'Patients were divided into carriers and non-carriers according to the carrier status of CYP2C19 loss-of-function (LOF) alleles', '339 patients, 170 were randomized to']","['Ticagrelor', 'clopidogrel/aspirin', 'Ticagrelor/aspirin', 'ticagrelor/aspirin', 'clopidogrel', 'ticagrelor versus clopidogrel', 'ticagrelor']","['HOPR', 'proportion of patients with high on-treatment platelet reactivity (HOPR', 'Platelet reactivity', 'proportion of HOPR', 'platelet reactivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0449439', 'cui_str': 'Carrier status'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C4517599', 'cui_str': '170'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",339.0,0.0541763,"Ticagrelor was superior to clopidogrel in inhibiting platelet reactivity measured by TEG platelet mapping among patients with acute minor stroke or TIA, particularly in carriers of the CYP2C19 LOF alleles.","[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Weiqi', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuesong', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}]",Aging,['10.18632/aging.103452']
1179,33066338,"Effect of a Short-Time Probiotic Supplementation on the Abundance of the Main Constituents of the Gut Microbiota of Term Newborns Delivered by Cesarean Section-A Randomized, Prospective, Controlled Clinical Trial.","The gut microbiota plays a pivotal role in the maintenance of human health. Numerous factors, including the mode of delivery, impact early gut colonization in newborns. Recent research focuses on the use of probiotics in the prevention of gut dysbiosis in newborns delivered by cesarean section (CS). The objective of this study was to determine whether a probiotic supplement given to newborns delivered by CS during their stay in the maternity ward alters the pattern of early gut colonization by lactic acid bacteria versus potential pathogens. A prospective, randomized trial was conducted. In total, 150 newborns, born at 38-40 weeks gestational age and delivered by CS, were included in the study. They were randomized into the intervention group, supplemented orally with a probiotic containing Bifidobacterium breve PB04 and Lactobacillus rhamnosus KL53A, and the control group. Stool samples were obtained on days 5 and 6 of life and after one month of life and were analyzed for the presence and abundance of the main groups of bacteria. An application of two probiotic bacteria during the first days of life after CS resulted in quick and abundant colonization by days 5 and 6, with high populations of L. rhamnosus and B. breve . The applied bacterial strains were present in the majority of neonates one month after. The supplementation of term neonates delivered by cesarean section immediately after birth with a mixture of L. rhamnosus and B. breve enriched the gut microbiota composition with lactic acid bacteria.",2020,Recent research focuses on the use of probiotics in the prevention of gut dysbiosis in newborns delivered by cesarean section (CS).,"['In total, 150 newborns, born at 38-40 weeks gestational age and delivered by CS, were included in the study', 'newborns delivered by cesarean section (CS', 'newborns']","['probiotic supplement', 'Short-Time Probiotic Supplementation', 'cesarean section immediately after birth with a mixture of', 'probiotic containing Bifidobacterium breve PB04 and Lactobacillus rhamnosus KL53A, and the control group', 'L. rhamnosus and B']",['quick and abundant colonization'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}]",150.0,0.035509,Recent research focuses on the use of probiotics in the prevention of gut dysbiosis in newborns delivered by cesarean section (CS).,"[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Hurkala', 'Affiliation': 'Neonatology Clinic, University Hospital, Medical College, Jagiellonian University, Kopernika 23 Str, 31-501 Kraków, Poland.'}, {'ForeName': 'Ryszard', 'Initials': 'R', 'LastName': 'Lauterbach', 'Affiliation': 'Neonatology Clinic, University Hospital, Medical College, Jagiellonian University, Kopernika 23 Str, 31-501 Kraków, Poland.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Radziszewska', 'Affiliation': 'Neonatology Clinic, University Hospital, Medical College, Jagiellonian University, Kopernika 23 Str, 31-501 Kraków, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Strus', 'Affiliation': 'Chair of Microbiology, Medical College, Jagiellonian University, Kraków, Czysta 18 Str, 31-121 Kraków, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Heczko', 'Affiliation': 'Chair of Microbiology, Medical College, Jagiellonian University, Kraków, Czysta 18 Str, 31-121 Kraków, Poland.'}]",Nutrients,['10.3390/nu12103128']
1180,33066348,An Acute Application of Cerebellar Transcranial Direct Current Stimulation Does Not Improve Motor Performance in Parkinson's Disease.,"Transcranial direct current stimulation of the cerebellum (c-tDCS) improves motor performance in young and old adults. Based on the cerebellar involvement in Parkinson's disease (PD), c-tDCS could have potential to improve motor function in PD. The purpose was to determine the effects of c-tDCS on motor performance in PD while participants were on medications. The study was a randomized, double-blind, SHAM-controlled, between-subjects design. Twenty-two participants with PD were allocated to either a c-tDCS group or a SHAM group. All participants completed one experimental session and performed two motor tasks with their most affected hand in a Baseline condition (no stimulation) and an Experimental condition. The motor tasks were a visuomotor isometric precision grip task (PGT) and a rapid arm movement task (AMT). The primary dependent variables were force error and endpoint error in the PGT and AMT, respectively. There were no significant differences in force error or endpoint error in the Experimental condition between the c-tDCS and SHAM groups. These results indicate that an acute application of c-tDCS does not enhance motor performance in hand and arm tasks in PD. Longer-term c-tDCS application over multiple days may be needed to enhance motor function in PD.",2020,There were no significant differences in force error or endpoint error in the Experimental condition between the c-tDCS and SHAM groups.,"[""Parkinson's Disease"", 'Twenty-two participants with PD', 'young and old adults']","['SHAM', 'Transcranial direct current stimulation of the cerebellum (c-tDCS', 'c-tDCS', 'Cerebellar Transcranial Direct Current Stimulation']","['Motor Performance', 'visuomotor isometric precision grip task (PGT) and a rapid arm movement task (AMT', 'force error and endpoint error', 'motor performance']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",22.0,0.189365,There were no significant differences in force error or endpoint error in the Experimental condition between the c-tDCS and SHAM groups.,"[{'ForeName': 'Lidio', 'Initials': 'L', 'LastName': 'Lima de Albuquerque', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Pantovic', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Mitchel', 'Initials': 'M', 'LastName': 'Clingo', 'Affiliation': 'School of Medicine, University of Nevada Las Vegas, Las Vegas, NV 89102, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Jalene', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Merrill', 'Initials': 'M', 'LastName': 'Landers', 'Affiliation': 'Department of Physical Therapy, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Zoltan', 'Initials': 'Z', 'LastName': 'Mari', 'Affiliation': 'Movement Disorders Program, Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV 89106, USA.'}, {'ForeName': 'Brach', 'Initials': 'B', 'LastName': 'Poston', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.'}]",Brain sciences,['10.3390/brainsci10100735']
1181,33066469,Chemically Activated Cooling Vest's Effect on Cooling Rate Following Exercise-Induced Hyperthermia: A Randomized Counter-Balanced Crossover Study.,"Background and objectives: Exertional heat stroke (EHS) is a potentially lethal, hyperthermic condition that warrants immediate cooling to optimize the patient outcome. The study aimed to examine if a portable cooling vest meets the established cooling criteria (0.15 °C·min -1 or greater) for EHS treatment. It was hypothesized that a cooling vest will not meet the established cooling criteria for EHS treatment. Materials and Methods: Fourteen recreationally active participants (mean ± SD; male, n = 8; age, 25 ± 4 years; body mass, 86.7 ± 10.5 kg; body fat, 16.5 ± 5.2%; body surface area, 2.06 ± 0.15 m 2 . female, n = 6; 22 ± 2 years; 61.3 ± 6.7 kg; 22.8 ± 4.4%; 1.66 ± 0.11 m 2 ) exercised on a motorized treadmill in a hot climatic chamber (ambient temperature 39.8 ± 1.9 °C, relative humidity 37.4 ± 6.9%) until they reached rectal temperature (T RE ) >39 °C (mean T RE , 39.59 ± 0.38 °C). Following exercise, participants were cooled using either a cooling vest (VEST) or passive rest (PASS) in the climatic chamber until T RE reached 38.25 °C. Trials were assigned using randomized, counter-balanced crossover design. Results: There was a main effect of cooling modality type on cooling rates (F[1, 24] = 10.46, p < 0.01, η 2 p = 0.30), with a greater cooling rate observed in VEST (0.06 ± 0.02 °C·min -1 ) than PASS (0.04 ± 0.01 °C·min -1 ) (MD = 0.02, 95% CI = [0.01, 0.03]). There were also main effects of sex (F[1, 24] = 5.97, p = 0.02, η 2 p = 0.20) and cooling modality type (F[1, 24] = 4.38, p = 0.047, η 2 p = 0.15) on cooling duration, with a faster cooling time in female (26.9 min) than male participants (42.2 min) (MD = 15.3 min, 95% CI = [2.4, 28.2]) and faster cooling duration in VEST than PASS (MD = 13.1 min, 95% CI = [0.2, 26.0]). An increased body mass was associated with a decreased cooling rate in PASS (r = -0.580, p = 0.03); however, this association was not significant in vest (r = -0.252, p = 0.39). Conclusions: Although VEST exhibited a greater cooling capacity than PASS, VEST was far below an acceptable cooling rate for EHS treatment. VEST should not replace immediate whole-body cold-water immersion when EHS is suspected.",2020,"There was a main effect of cooling modality type on cooling rates (F[1, 24] = 10.46, p < 0.01, η 2 p = 0.30), with a greater cooling rate observed in VEST (0.06 ± 0.02","['female, n = 6; 22 ± 2 years; 61.3 ± 6.7 kg; 22.8 ± 4.4%; 1.66 ± 0.11 m 2 ) exercised on a', 'Fourteen recreationally active participants (mean ± SD; male, n = 8; age, 25 ± 4 years; body mass, 86.7 ± 10.5 kg; body fat, 16.5 ± 5.2%; body surface area, 2.06 ± 0.15 m 2 ']","['VEST', '°C·min -1 ', 'cooling vest (VEST) or passive rest (PASS', 'Exercise-Induced Hyperthermia', 'motorized treadmill in a hot climatic chamber']","['cooling rate', 'cooling rates', 'faster cooling duration', 'cooling rate in PASS', 'Cooling Rate', 'faster cooling time in female', 'cooling capacity', 'cooling duration', 'body mass']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C4517510', 'cui_str': '1.66'}, {'cui': 'C4517425', 'cui_str': '0.11'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C4068886', 'cui_str': '0.15'}]","[{'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0444519', 'cui_str': 'Hot'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",,0.144512,"There was a main effect of cooling modality type on cooling rates (F[1, 24] = 10.46, p < 0.01, η 2 p = 0.30), with a greater cooling rate observed in VEST (0.06 ± 0.02","[{'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Hosokawa', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Saitama 359-1192, Japan.'}, {'ForeName': 'Luke N', 'Initials': 'LN', 'LastName': 'Belval', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX 75231, USA.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Adams', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC 27412, USA.'}, {'ForeName': 'Lesley W', 'Initials': 'LW', 'LastName': 'Vandermark', 'Affiliation': 'Department of Health, Human Performance, and Recreation, University of Arkansas, Fayetteville, AR 72701, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Casa', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, CT 06269, USA.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56100539']
1182,33066593,Exercise Intensity May Not Moderate the Acute Effects of Functional Circuit Training on Cognitive Function: A Randomized Crossover Trial.,"Functional circuit training (FCT) has been demonstrated to acutely enhance cognitive performance (CP). However, the moderators of this observation are unknown. This study aimed to elucidate the role of exercise intensity. According to an a priori sample size calculation, n = 24 healthy participants (26 ± 3 years, 13 females), in randomized order, performed a single 15-min bout of FCT with low (20-39% of the heart rate reserve/HRR), moderate (40-59% HRR) or high intensity (maximal effort). Immediately pre- and post-workout, CP was measured by use of the Digit Span test, Stroop test and Trail Making test. Non-parametric data analyses did not reveal significant differences between conditions ( p > 0.05) although parameter-free 95% confidence intervals showed pre-post improvements in some outcomes at moderate and high intensity only. The effort level does not seem to be a major effect modifier regarding short-term increases in CP following HCT in young active adults.",2020,The effort level does not seem to be a major effect modifier regarding short-term increases in CP following HCT in young active adults.,"['24 healthy participants (26 ± 3 years, 13 females', 'young active adults']","['Functional Circuit Training', 'Functional circuit training (FCT']",['Cognitive Function'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",24.0,0.0300091,The effort level does not seem to be a major effect modifier regarding short-term increases in CP following HCT in young active adults.,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wilke', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt, 60488 Frankfurt am Main, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Royé', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt, 60488 Frankfurt am Main, Germany.'}]",Brain sciences,['10.3390/brainsci10100738']
1183,33068669,"The effect of transcranial direct current stimulation (tDCS) on food craving, reward and appetite in a healthy population.","The ability to control hedonic appetite is associated with executive functioning, originating in the prefrontal cortex (PFC). These rewarding components of food can override homeostatic mechanisms, potentiating obesogenic behaviours. Indeed, those susceptible to overconsumption appear to have PFC hypo-activation. Transcranial direct current stimulation (tDCS) over the dorsolateral PFC (DLPFC) has been shown to reduce food craving and consumption, potentially via attenuating this reward response. We examined the effects of stimulation on food reward and craving using a healthy-weight cohort. This study is amongst the first to explore the effects of tDCS on explicit and implicit components of reward for different food categories. Twenty-one healthy-weight participants (24 ± 7 years, 22.8 ± 2.3 kg m -2 ) completed two sessions involving double-blind, randomised and counterbalanced anodal or sham tDCS over the right DLPFC, at 2 mA for 20 min. Food craving (Food Craving Questionnaire-State), reward (Leeds Food Preference Questionnaire), and subjective appetite (100 mm visual analogue scales) were measured pre- and post-tDCS. Eating behaviour trait susceptibility was assessed using the Three Factor Eating Questionnaire-Short Form, Control of Eating Questionnaire, and Food Craving Questionnaire-Trait-reduced. Stimulation did not alter food craving, reward or appetite in healthy-weight participants who displayed low susceptibility to overconsumption, with low trait craving, good craving control, and low uncontrolled eating and emotional eating behaviour. Implicit and explicit reward were reliable measures of hedonic appetite, suggesting these are robust targets for future tDCS research. These findings suggest that applying tDCS over the DLPFC does not change food reward response in individuals not at risk for overconsumption, and future work should focus on those at risk of overconsumption who may be more responsive to the effects of tDCS on hedonic appetite.",2020,"Stimulation did not alter food craving, reward or appetite in healthy-weight participants who displayed low susceptibility to overconsumption, with low trait craving, good craving control, and low uncontrolled eating and emotional eating behaviour.","['healthy-weight cohort', 'healthy population', 'Twenty-one healthy-weight participants (24 ± 7 years, 22.8 ± 2.3 kg·m -2 ', 'healthy-weight participants who displayed low susceptibility to overconsumption, with low trait craving, good craving control, and low uncontrolled eating and emotional eating behaviour']","['Transcranial direct current stimulation (tDCS', 'dorsolateral PFC (DLPFC', 'transcranial direct current stimulation (tDCS', 'counterbalanced anodal or sham tDCS', 'tDCS']","['food reward and craving', 'Factor Eating Questionnaire-Short Form, Control of Eating Questionnaire, and Food Craving Questionnaire-Trait-reduced', 'Food craving (Food Craving Questionnaire-State), reward (Leeds Food Preference Questionnaire), and subjective appetite (100 mm visual analogue scales', 'hedonic appetite', 'food craving, reward and appetite', 'Eating behaviour trait susceptibility', 'food craving, reward or appetite']","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C2983598', 'cui_str': 'Dorsolateral'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]",21.0,0.0334459,"Stimulation did not alter food craving, reward or appetite in healthy-weight participants who displayed low susceptibility to overconsumption, with low trait craving, good craving control, and low uncontrolled eating and emotional eating behaviour.","[{'ForeName': 'Jordan D', 'Initials': 'JD', 'LastName': 'Beaumont', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, LS18 5HD, UK. Electronic address: j.beaumont@leedstrinity.ac.uk.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Davis', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, LS18 5HD, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Dalton', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, LS18 5HD, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nowicky', 'Affiliation': 'Centre for Cognitive Neuroscience, Department of Clinical Sciences, College of Health and Life Sciences, Brunel University London, Uxbridge, UB8 3PH, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Russell', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, LS18 5HD, UK.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Barwood', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, LS18 5HD, UK.'}]",Appetite,['10.1016/j.appet.2020.105004']
1184,32622225,The impact of adult trauma triage training on decision-making skills and accuracy of triage decision at emergency departments in Malaysia: A randomized control trial.,"INTRODUCTION
Patients who visit emergency departments need to undergo a precise assessment to determine their priority and accurate triage category to ensure they receive the right treatment.
AIM
To identify the effect of triage training on the skills and accuracy of triage decisions for adult trauma patients.
METHOD
A randomized controlled trial design was conducted in ten emergency department of public hospitals. A total of 143 registered nurses and medical officer assistants who performed triage roles were recruited for the control group (n = 74) and the intervention group (n = 69). The skill and accuracy of triage decisions were measured two weeks and four weeks after the intervention group were exposed to the intervention.
RESULTS
There was a significant effect on the skill of triage decision-making between the control and the intervention group p < 0.001, η 2 partial = 0.31. Concerning the accuracy of triage decisions, the effect was significantly different between the control group and the intervention group p < 0.001, η 2 partial = 0.66 across time.
CONCLUSION
The triage training improved the skills of the participants and the accuracy of triage decision-making across time.",2020,"There was a significant effect on the skill of triage decision-making between the control and the intervention group p < 0.001, η 2 partial = 0.31.","['emergency departments in Malaysia', 'Patients who visit emergency departments', 'ten emergency department of public hospitals', '143 registered nurses and medical officer assistants who performed triage roles were recruited for the control group (n\xa0=\xa074) and the intervention group (n\xa0=\xa069', 'adult trauma patients']","['triage training', 'adult trauma triage training']","['skill and accuracy of triage decisions', 'skill of triage decision-making']","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0557516', 'cui_str': 'Medical officer'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",143.0,0.0515258,"There was a significant effect on the skill of triage decision-making between the control and the intervention group p < 0.001, η 2 partial = 0.31.","[{'ForeName': 'Siti Aishah', 'Initials': 'SA', 'LastName': 'Ghazali', 'Affiliation': 'School of Health Sciences, Health Campus, Universiti Sains Malaysia, Kelantan, Malaysia; Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Electronic address: schah@usm.my.'}, {'ForeName': 'Khatijah Lim', 'Initials': 'KL', 'LastName': 'Abdullah', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Electronic address: katlim@um.edu.my.'}, {'ForeName': 'Foong Ming', 'Initials': 'FM', 'LastName': 'Moy', 'Affiliation': 'Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Electronic address: moyfm@ummc.edu.my.'}, {'ForeName': 'Rashidi', 'Initials': 'R', 'LastName': 'Ahmad', 'Affiliation': 'Department of Emergency Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Electronic address: rashidi@ummc.edu.my.'}, {'ForeName': 'Emni Omar Daw', 'Initials': 'EOD', 'LastName': 'Hussin', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.'}]",International emergency nursing,['10.1016/j.ienj.2020.100889']
1185,32628115,Evaluation of Adaptive Feedback in a Smartphone-Based Game on Health Care Providers' Learning Gain: Randomized Controlled Trial.,"BACKGROUND
Although smartphone-based emergency care training is more affordable than traditional avenues of training, it is still in its infancy, remains poorly implemented, and its current implementation modes tend to be invariant to the evolving learning needs of the intended users. In resource-limited settings, the use of such platforms coupled with gamified approaches remains largely unexplored, despite the lack of traditional training opportunities, and high mortality rates in these settings.
OBJECTIVE
The primary aim of this randomized experiment is to determine the effectiveness of offering adaptive versus standard feedback, on the learning gains of clinicians, through the use of a smartphone-based game that assessed their management of a simulated medical emergency. A secondary aim is to examine the effects of learner characteristics and learning spacing with repeated use of the game on the secondary outcome of individualized normalized learning gain.
METHODS
The experiment is aimed at clinicians who provide bedside neonatal care in low-income settings. Data were captured through an Android app installed on the study participants' personal phones. The intervention, which was based on successful attempts at a learning task, included adaptive feedback provided within the app to the experimental arm, whereas the control arm received standardized feedback. The primary end point was completion of the second learning session. Of the 572 participants enrolled between February 2019 and July 2019, 247 (43.2%) reached the primary end point. The primary outcome was standardized relative change in learning gains between the study arms as measured by the Morris G effect size. The secondary outcomes were the participants individualized normalized learning gains.
RESULTS
The effect of adaptive feedback on care providers' learning gain was found to be g=0.09 (95% CI -0.31 to 0.46; P=.47). In exploratory analysis, using normalized learning gains, when subject-treatment interaction and differential time effect was controlled for, this effect increased significantly to 0.644 (95% CI 0.35 to 0.94; P<.001) with immediate repetition, which is a moderate learning effect, but reduced significantly by 0.28 after a week. The overall learning change from the app use in both arms was large and may have obscured a direct effect of feedback.
CONCLUSIONS
There is a considerable learning gain between the first two rounds of learning with both forms of feedback and a small added benefit of adaptive feedback after controlling for learner differences. We suggest that linking the adaptive feedback provided to care providers to how they space their repeat learning session(s) may yield higher learning gains. Future work might explore in more depth the feedback content, in particular whether or not explanatory feedback (why answers were wrong) enhances learning more than reflective feedback (information about what the right answers are).
TRIAL REGISTRATION
Pan African Clinical Trial Registry (PACTR) 201901783811130; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5836.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.2196/13034.",2020,"The primary aim of this randomized experiment is to determine the effectiveness of offering adaptive versus standard feedback, on the learning gains of clinicians, through the use of a smartphone-based game that assessed their management of a simulated medical emergency.","[""Health Care Providers' Learning Gain"", '572 participants enrolled between February 2019 and July 2019, 247 (43.2%) reached the primary end point']","['adaptive feedback', 'smartphone-based emergency care training']","['overall learning change', 'learning gain', ""care providers' learning gain"", 'completion of the second learning session', 'individualized normalized learning gains', 'standardized relative change in learning gains']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",572.0,0.0972468,"The primary aim of this randomized experiment is to determine the effectiveness of offering adaptive versus standard feedback, on the learning gains of clinicians, through the use of a smartphone-based game that assessed their management of a simulated medical emergency.","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Tuti', 'Affiliation': 'Kellogg College, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Winters', 'Affiliation': 'Kellogg College, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Edgcombe', 'Affiliation': 'Nuffield Division of Anaesthetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Muinga', 'Affiliation': 'KEMRI-Wellcome Trust Research Programme, Nairobi, Kenya.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Wanyama', 'Affiliation': 'KEMRI-Wellcome Trust Research Programme, Nairobi, Kenya.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'English', 'Affiliation': 'KEMRI-Wellcome Trust Research Programme, Nairobi, Kenya.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Paton', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}]",Journal of medical Internet research,['10.2196/17100']
1186,32628117,"Use of an Unguided, Web-Based Distress Self-Management Program After Breast Cancer Diagnosis: Sub-Analysis of CaringGuidance Pilot Study.","BACKGROUND
Unguided, web-based psychoeducational interventions are gaining interest as a way to reach patients while reducing pressure on clinical resources. However, there has been little research on how patients with cancer use these interventions.
OBJECTIVE
The objective of this analysis was to evaluate how women newly diagnosed with breast cancer used the unguided web-based, psychoeducational distress self-management program CaringGuidance After Breast Cancer Diagnosis while enrolled in a pilot feasibility study.
METHODS
Women with stage 0 to II breast cancer diagnosed within the prior three months were recruited from clinics primarily in the Northeastern United States for participation in a 12-week pilot study of CaringGuidance plus usual care versus usual care alone. Usage prompts included sets of emails sent weekly for 12 weeks; standardized congratulatory emails after every two hours of program use, and informative emails for each cognitive-behavioral exercise. Individual user activity on the site was automatically tracked by an analytics system and recorded directly in the CaringGuidance database.
RESULTS
Complete usage data were available for 54 subjects. Ninety-eight percent of the intervention group logged into CaringGuidance independently at least once. Thirty-eight (70%) logged in during all three months, 15 (28%) were intermittent users, and one (2%) was a non-user. Users (n=53) averaged 15.6 (SD 9.85) logins. Mean logins were greatest in month 1 (7.26, SD 4.02) and declined in months 2 (4.32, SD 3.66) and month 3 (4.02, SD 3.82). Eleven (21%) used CaringGuidance with both the frequency and activity level intended at study outset, 9 (17%) exceeded intended frequency and activity (high-high users), and 10 (19%) were below expected usage on both login frequency and activity (low-low users). Low-low users and high-high users differed significantly (P<.001) in the total number of views and unique views of all program components. Change in depressive symptoms and the number of sessions (r=.351) and logins (r=.348) between study months 1 and 2 were significantly correlated (P=.018, .019). Higher baseline distress was associated with more unique views of program resources (r=.281, P=.043). Change in intrusive/avoidant thoughts from baseline to month 3, and the number of users' unique exercise views were negatively correlated (r=-.319, P=.035) so that more unique exercise views, equated with greater decline in intrusive/avoidant thoughts from baseline to month 3.
CONCLUSIONS
These findings favor the hypothesis that the key ingredient is not the amount of program use, but each user's self-selected activity within the program. More research is needed on the ideal ways to maintain use, and capture and define engagement and enactment of behaviors by people with cancer accessing unguided, self-management web-based programs.",2020,"Higher baseline distress was associated with more unique views of program resources (r=.281, P=.043).","['Women with stage 0 to II breast cancer diagnosed within the prior three months were recruited from clinics primarily in the Northeastern United States for participation in a 12-week pilot study of', 'After Breast Cancer Diagnosis', 'women newly diagnosed with breast cancer', 'patients with cancer']","['unguided web-based, psychoeducational distress self-management program CaringGuidance', 'CaringGuidance plus usual care versus usual care alone', 'Unguided, Web-Based Distress Self-Management Program']","['Mean logins', 'Change in depressive symptoms', 'frequency and activity level', ""number of users' unique exercise views""]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441763', 'cui_str': 'Stage 0'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0678222', 'cui_str': 'Carcinoma of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449911', 'cui_str': 'View'}]",,0.0408537,"Higher baseline distress was associated with more unique views of program resources (r=.281, P=.043).","[{'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Lally', 'Affiliation': 'College of Nursing, Fred & Pamela Buffett Cancer Center, University of Nebraska Medical Center, Omaha, NE, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kupzyk', 'Affiliation': 'College of Nursing, University of Nebraska Medical Center, Omaha, NE, United States.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': 'Center for Computational Research, Roswell Park Cancer Center, Buffalo, NY, United States.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Berry', 'Affiliation': 'School of Nursing, University of Washington, Seattle, WA, United States.'}]",Journal of medical Internet research,['10.2196/19734']
1187,32623977,Sex Differences in Blood Pressure-Lowering Therapy and Outcomes Following Intracerebral Hemorrhage: Results From ATACH-2.,"BACKGROUND AND PURPOSE
Evidence regarding sex differences in clinical outcomes and treatment effect following intracerebral hemorrhage is limited. Using the ATACH-2 trial (Antihypertensive Treatment in Intracerebral Hemorrhage-2) data, we explored whether sex disparities exist in outcomes and response to intensive blood pressure (BP)-lowering therapy.
METHODS
Eligible intracerebral hemorrhage subjects were randomly assigned to intensive (target systolic BP, 110-139 mm Hg) or standard (140-179 mm Hg) BP-lowering therapy within 4.5 hours after onset. Relative risk of death or disability corresponding to the modified Rankin Scale score of 4 to 6 was calculated, and interaction between sex and treatment was explored.
RESULTS
In total, 380 women and 620 men were included. Women were older, more prescribed antihypertensive drugs before onset, and had more lobar intracerebral hemorrhage than men. Hematoma expansion was observed less in women. After multivariable adjustment, the relative risk of death or disability in women was 1.19 (95% CI, 1.02-1.37, P =0.023). The relative risk of death or disability between intensive versus standard BP-lowering therapy was 0.91 (95% CI, 0.74-1.13) in women versus 1.13 (95% CI, 0.92-1.39) in men ( P for interaction=0.11), with inconclusive Gail-Simmon test ( P =0.16).
CONCLUSIONS
Women had a higher risk of death or disability following intracerebral hemorrhage. The benefit of intensive BP-lowering therapy in women is inconclusive, consistent with the overall results of ATACH-2. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01176565.",2020,"The relative risk of death or disability between intensive versus standard BP-lowering therapy was 0.91 (95% CI, 0.74-1.13) in women versus 1.13 (95% CI, 0.92-1.39) in men (","['Eligible intracerebral hemorrhage subjects', '380 women and 620 men were included', 'Women were older, more prescribed antihypertensive drugs before onset, and had more lobar intracerebral hemorrhage than men']","['intensive BP-lowering therapy', 'Hg) BP-lowering therapy']","['Hematoma expansion', 'risk of death or disability', 'relative risk of death or disability', 'Relative risk of death or disability corresponding to the modified Rankin Scale score']","[{'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",380.0,0.38882,"The relative risk of death or disability between intensive versus standard BP-lowering therapy was 0.91 (95% CI, 0.74-1.13) in women versus 1.13 (95% CI, 0.92-1.39) in men (","[{'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Fukuda-Doi', 'Affiliation': 'Department of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., K.T.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Center for Advancing Clinical and Translational Sciences (M.F.-D., H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Koga', 'Affiliation': 'Department of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., K.T.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., V.L.D.-M.).'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Durkalski-Mauldin', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., V.L.D.-M.).'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenat Qureshi Stroke Institute, St. Cloud, MN (A.I.Q.).'}, {'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'Department of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., K.T.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Okazaki', 'Affiliation': 'Department of Neurology (S. Okazaki), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Miwa', 'Affiliation': 'Department of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., K.T.), National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Center Clinical Research Institute, Fukuoka, Japan (Y.O.).'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'Department of Strokology, Stroke Center, St. Marianna University Toyoko Hospital, Kawasaki, Japan (T.U.).'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Okuda', 'Affiliation': 'Department of Neurology, National Hospital Organization Nagoya Medical Center, Japan (S. Okuda).'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Nakahara', 'Affiliation': 'Department of Neurology, Keio University School of Medicine, Tokyo, Japan (M.F.-D., J.N., N.S., K.T.).'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': 'Department of Neurology, Keio University School of Medicine, Tokyo, Japan (M.F.-D., J.N., N.S., K.T.).'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., K.T.), National Cerebral and Cardiovascular Center, Suita, Japan.'}]",Stroke,['10.1161/STROKEAHA.120.029770']
1188,32624004,Effects of a physical activity program from diagnosis on cardiorespiratory fitness in children with cancer: a national non-randomized controlled trial.,"BACKGROUND
Children with cancer experience impaired cardiorespiratory fitness and physical function during and after treatment restricting their possibilities to engage in social activities including sport, leisure activities, and school. The objectives were to determine the effects of classmate-supported, controlled, supervised, in-hospital, physical activity program to preserve cardiorespiratory fitness and physical function from time of diagnosis in children with cancer.
METHODS
National non-randomized controlled trial including schoolchildren aged 6-18 years at diagnosis treated with chemo-/radiotherapy. We included 120 of 128 eligible patients (94%) in the intervention group (62.5% boys, 11.2 ± 3.1 years) from East Denmark and 58 patients in the control group (57% boys, 11.0 ± 3.2 years) from West Denmark. Eight children from the control group withdrew from participation. The groups were comparable in anthropometrics and cancer diagnoses (p > 0.05). The intervention consisted of (i) supervised in-hospital physical activity from diagnosis and throughout intensive treatment, (ii) 90-min general educational session on cancer and therapy in the child's school class, and (iii) selection of two classmates as ambassadors who took turns to support the child's physical training during the daytime. The primary outcome was cardiorespiratory fitness (VO 2 peak, mL/min/kg) at 6 months after diagnosis (sex, age, diagnosis adjusted). Secondary outcomes were sit-to-stand, timed-up-and-go, handgrip strength, and balance test scores.
RESULTS
Ambassadors were identified for all, and 2542 individual and 621 group training sessions were held. VO 2 peak deteriorated over time in the control group (- 0.17 [95% CI - 0.32 to - 0.02] per week, p = 0.02), but not in the intervention group (p = 0.14). At 6 months from diagnosis, VO 2 peak was higher in the intervention group (29.6 ± 5.6 mL/kg/min) than in the control group (22.1 ± 5.6 mL/kg/min) (p = 0.01), and the intervention group had a better physical function at 3 and 6 months (p < 0.0001).
CONCLUSIONS
Peer-supported, supervised, in-hospital, physical activity is safe and feasible in children with cancer during treatment. Further, the results suggest that the intervention might mitigate impairments in cardiorespiratory fitness during treatment in children with cancer.
TRIAL REGISTRATION
The study was prospectively registered on the 11 January 2013. Clinicaltrial.gov NCT01772849 and NCT01772862 .",2020,"At 6 months from diagnosis, VO 2 peak was higher in the intervention group (29.6 ± 5.6 mL/kg/min) than in the control group (22.1 ± 5.6 mL/kg/min) (p = 0.01), and the intervention group had a better physical function at 3 and 6 months (p < 0.0001).
","['11 January 2013', 'children with cancer', 'children with cancer during treatment', 'Children with cancer experience', '120 of 128 eligible patients (94%) in the intervention group (62.5% boys, 11.2\u2009±\u20093.1\u2009years) from East Denmark and 58 patients in the control group (57% boys, 11.0\u2009±\u20093.2\u2009years) from West Denmark', 'schoolchildren aged 6-18\u2009years at diagnosis treated with']","[""intervention consisted of (i) supervised in-hospital physical activity from diagnosis and throughout intensive treatment, (ii) 90-min general educational session on cancer and therapy in the child's school class, and (iii) selection of two classmates as ambassadors who took turns to support the child's physical training"", 'physical activity program', 'chemo-/radiotherapy']","['physical function', 'VO 2 peak', 'cardiorespiratory fitness (VO 2 peak, mL/min/kg', 'VO 2 peak deteriorated over time', 'sit-to-stand, timed-up-and-go, handgrip strength, and balance test scores', 'anthropometrics and cancer diagnoses', 'cardiorespiratory fitness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",8.0,0.0404822,"At 6 months from diagnosis, VO 2 peak was higher in the intervention group (29.6 ± 5.6 mL/kg/min) than in the control group (22.1 ± 5.6 mL/kg/min) (p = 0.01), and the intervention group had a better physical function at 3 and 6 months (p < 0.0001).
","[{'ForeName': 'Martin Kaj Fridh', 'Initials': 'MKF', 'LastName': 'Nielsen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, The Juliane Marie Center, University Hospital of Copenhagen (Rigshospitalet), Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Jesper Frank', 'Initials': 'JF', 'LastName': 'Christensen', 'Affiliation': 'Center for Inflammation and Metabolism/Center for Physical Activity (CIM/CFAS), University Hospital (Rigshospitalet), Copenhagen, Denmark.'}, {'ForeName': 'Thomas Leth', 'Initials': 'TL', 'LastName': 'Frandsen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, The Juliane Marie Center, University Hospital of Copenhagen (Rigshospitalet), Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Troels', 'Initials': 'T', 'LastName': 'Thorsteinsson', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, The Juliane Marie Center, University Hospital of Copenhagen (Rigshospitalet), Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Lars Bo', 'Initials': 'LB', 'LastName': 'Andersen', 'Affiliation': 'Department of Sports Medicine, Norwegian School for Sports Sciences, Oslo, Norway.'}, {'ForeName': 'Karl Bang', 'Initials': 'KB', 'LastName': 'Christensen', 'Affiliation': 'Department of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peder Skov', 'Initials': 'PS', 'LastName': 'Wehner', 'Affiliation': ""Department of Pediatric Hematology and Oncology, H.C. Andersen Children's Hospital, Odense University Hospital, Odense, Denmark.""}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hasle', 'Affiliation': 'Pediatrics and Adolescent Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Lis Ørgaard', 'Initials': 'LØ', 'LastName': 'Adamsen', 'Affiliation': 'Faculty of Health Science, Department of Public Health, Institute for Clinical Medicine, The University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Schmiegelow', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, The Juliane Marie Center, University Hospital of Copenhagen (Rigshospitalet), Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Hanne Bækgaard', 'Initials': 'HB', 'LastName': 'Larsen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, The Juliane Marie Center, University Hospital of Copenhagen (Rigshospitalet), Blegdamsvej 9, DK-2100, Copenhagen, Denmark. hanne.baekgaard.larsen@regionh.dk.'}]",BMC medicine,['10.1186/s12916-020-01634-6']
1189,32629446,Phase III Randomized Study of Induction Chemotherapy Followed by Definitive Radiotherapy + Cetuximab Versus Chemoradiotherapy in Squamous Cell Carcinoma of Head and Neck: The INTERCEPTOR-GONO Study (NCT00999700).,"OBJECTIVES
Induction chemotherapy followed by cetuximab and RT (IBRT) (Arm A) was compared to cisplatin/RT (CRT) (Arm B) in a randomized phase III study.
PATIENTS AND METHODS
Naïve patients with stage III-IVa, histologically proven locally advanced head and neck cancer (LASCCHN) were eligible. Arm A (IBRT): 3 TPF induction followed by cetuximab-RT (equivalent daily dose 2 Gy up to 70 Gy); Arm B: 3 cisplatin concurrent with the same RT scheduling. Due to slow accrual and incomplete data collection a futility analysis was performed.
RESULTS
236/282 patients were evaluable. Therefore, no formal analyses can be made between the two arms. OS was 45.2/53.6 months in Arm A/B. Complete responses were achieved in 64% of patients in both arms. Neutropenia and skin toxicity were significantly worse in Arm A and body weight loss was significantly worse in Arm B. Compliance with the planned drug administration was higher in Arm B (p = 0.0008).
CONCLUSION
The study suggests that IBRT and CRT have similar efficacy, activity and toxicity.",2020,OS was 45.2/53.6 months in Arm A/B. Complete responses were achieved in 64% of patients in both arms.,"['236/282 patients were evaluable', 'Naïve patients with stage III-IVa, histologically proven locally advanced head and neck cancer (LASCCHN) were eligible', 'Squamous Cell Carcinoma of Head and Neck']","['cisplatin/RT (CRT', 'cetuximab and RT (IBRT', 'IBRT and CRT', 'Induction Chemotherapy Followed by Definitive Radiotherapy + Cetuximab Versus Chemoradiotherapy', 'cetuximab-RT']","['body weight loss', 'efficacy, activity and toxicity', 'OS', 'Neutropenia and skin toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}]",,0.0219668,OS was 45.2/53.6 months in Arm A/B. Complete responses were achieved in 64% of patients in both arms.,"[{'ForeName': 'Marco Carlo', 'Initials': 'MC', 'LastName': 'Merlano', 'Affiliation': 'Medical Oncology, St. Croce & Carle University Teaching Hospital and ARCO Foundation, Cuneo, Italy.'}, {'ForeName': 'Nerina', 'Initials': 'N', 'LastName': 'Denaro', 'Affiliation': 'Medical Oncology, St. Croce & Carle University Teaching Hospital and ARCO Foundation, Cuneo, Italy, nerinadenaro@hotmail.com.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Vecchio', 'Affiliation': 'Medical Oncology, IRCCS San Martino, IST National Cancer Institute and University of Genova, Genova, Italy.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Head and Neck Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, University of Milan, Milan, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Curcio', 'Affiliation': 'Trials Office, Medical Oncology, St. Croce & Carle University Teaching Hospital, Cuneo, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Benasso', 'Affiliation': 'Medical Oncology, San Paolo General Hospital, Savona, Italy.'}, {'ForeName': 'Almalina', 'Initials': 'A', 'LastName': 'Bagicalupo', 'Affiliation': 'Radiation Oncology, San Martino Hospital, Genova, Italy.'}, {'ForeName': 'Gianmauro', 'Initials': 'G', 'LastName': 'Numico', 'Affiliation': 'Medical Oncology, SS Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy.'}, {'ForeName': 'Elvio', 'Initials': 'E', 'LastName': 'Russi', 'Affiliation': 'Radiation Oncology, St. Croce & Carle University Teaching Hospital, Cuneo, Italy.'}, {'ForeName': 'Renzo', 'Initials': 'R', 'LastName': ""Corvo'"", 'Affiliation': 'Medical Oncology, IRCCS San Martino, IST National Cancer Institute and University of Genova, Genova, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bruzzi', 'Affiliation': 'Statistic Unit, Genova University, Genova, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Oncology,['10.1159/000507733']
1190,32631243,Effects of a work stress intervention on healthcare use and treatment compared to treatment as usual: a randomised controlled trial in Swedish primary healthcare.,"BACKGROUND
Work stress is an increasing burden in society. Identifying early symptoms of work stress in primary healthcare (PHC) could result in earlier and better-targeted care. The Work Stress Questionnaire (WSQ) was developed in PHC for this task. We aimed to evaluate whether the use of the WSQ, in combination with physicians' feedback, resulted in differences in healthcare visits and treatment compared to treatment as usual (TAU) in patients reporting high stress. Our hypothesis was that patients receiving the intervention would generate more visits to rehabilitation providers during follow-up compared to TAU.
METHODS
A two-armed randomised controlled trial was conducted at seven primary healthcare centres (PHCCs) in Region Västra Götaland, Sweden. One group received the WSQ intervention, and the controls received TAU. Employed, not sick-listed persons aged 18-64 years who sought care for mental or physical health complaints at the PHCCs participated. Register data on healthcare visits and treatments 12 months prior to inclusion and 12 months after were obtained and analysed with Fisher's exact test together with questionnaire data (WSQ and background features).
RESULTS
A total of 271 participants were included in the study, 132 intervention and 139 controls. Visits to psychologists/psychotherapists were higher among intervention participants with high stress (20%, n = 87) during follow-up compared to corresponding controls (7%, n = 97) (p < 0.05). Collaborative care measures were more common among the stressed intervention participants (23%) post-inclusion compared to the stressed controls (11%) (p < 0.05). The amount of received cognitive behavioural therapy (CBT) was higher among the stressed intervention group (16%) than among controls (10%) during follow-up.
CONCLUSIONS
The intervention group that used the WSQ with physicians' feedback had an increased number of rehabilitative measures and treatment more in line with established guidelines compared to treatment as usual. Findings of the study indicate that the WSQ can assist in identifying work stress in primary healthcare and contribute to physicians' recommendations of suitable rehabilitative measures at an earlier stage compared to treatment as usual.
TRIAL REGISTRATION
ClinicalTrials.gov. Identifier: NCT02480855 . Registered 20 May 2015.",2020,Collaborative care measures were more common among the stressed intervention participants (23%) post-inclusion compared to the stressed controls (11%) (p < 0.05).,"['sick-listed persons aged 18-64\u2009years who sought care for mental or physical health complaints at the PHCCs participated', 'patients reporting high stress', 'A two-armed randomised controlled trial was conducted at seven primary healthcare centres (PHCCs) in Region Västra Götaland, Sweden', 'Swedish primary healthcare', 'A total of 271 participants were included in the study, 132 intervention and 139 controls']","['WSQ intervention, and the controls received TAU', 'work stress intervention', 'WSQ', 'cognitive behavioural therapy (CBT', ""WSQ with physicians' feedback""]","['Work Stress Questionnaire (WSQ', 'number of rehabilitative measures']","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C5191072', 'cui_str': '139'}]","[{'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",271.0,0.106091,Collaborative care measures were more common among the stressed intervention participants (23%) post-inclusion compared to the stressed controls (11%) (p < 0.05).,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Sandheimer', 'Affiliation': 'School of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Christine.sandheimer@gu.se.'}, {'ForeName': 'Tove', 'Initials': 'T', 'LastName': 'Hedenrud', 'Affiliation': 'School of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Gunnel', 'Initials': 'G', 'LastName': 'Hensing', 'Affiliation': 'School of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Holmgren', 'Affiliation': 'Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",BMC family practice,['10.1186/s12875-020-01210-0']
1191,32631301,"The clinical effect of dexmedetomidine combined with parecoxib sodium on sedation, antianxiety and prevention of intubation stress in patients undergoing functional endoscopic sinus surgery: a randomised controlled trial.","BACKGROUND
To investigate the effect of intravenous injection of dexmedetomidine combined with parecoxib sodium on sedation and anxiety and stress response of tracheal intubation in patients undergoing functional endoscopic sinus surgery.
METHODS
One hundred twenty patients undergoing endoscopic sinus surgery were randomly divided into four groups: group DP, group D, group P and group N. The blood pressure (BP), heart rate (HR), blood oxygen saturation (SPO2), EEG, bispectral index (BIS), Ramsay sedation score and state anxiety questionnaire (SAI) were recorded before administration (T0), 10 min (T1), 20 min (T2) and 30 min (T3) after administration. After 30 min, endotracheal intubation was performed after anesthesia induction. The BP, HR, SPO2 were recorded 1 min before intubation (T4), intubation (T5), 3 min (T6) after intubation, 5 min (T7) after intubation, and blood samples were collected from patients before administration and after intubation 2 min to detect serum cortisol (Cor), adrenalin (E) norepinephrine (NE) and blood glucose (BS).
RESULTS
There was no significant difference in Ramsay sedation score before anesthesia, but the Ramsay sedation score in group D、DP was significantly higher than that in group P and group N, the BIS, BP, HR and anxiety scores were significantly lower than those in the group P and group N (p < 0.05). There was no significant difference in Ramsay sedation score, BIS value, anxiety score and BP, HR between group D and group DP (p > 0.05). Compared with T4, there was no significant difference in BIS and BP, HR in group D, group DP and group P (p > 0.05), but the BIS, BP and HR in group N were significantly higher than T4, (p < 0.05). Three minutes after intubation there was no statistical difference in the changes of Cor, E, NE and BS values compared with before intubation in group P and group DP (p > 0.05), but the changes of Cor, E, NE and BS values were significantly lower than that in group N (p < 0.05). Compared with T0, the values of NE, E, Cor, BS decreased in group D, DP and P at T4, group DP decreased more significantly than group D (p < 0.05). while the NE, E, Cor, BS of T6 are at the same level as the base value. In group N, the NE, E, Cor, BS of T4 were at the same level of T0, but significantly higher at T6.And at T6, NE and E in group D, P and N were significantly different from those in group DP (p < 0.05).
CONCLUSION
Preoperative intravenous infusion of dexmedetomidine combined with parecoxib sodium by functional nasal endoscopy can not only calm and resist anxiety, but also better prevent stress response of endotracheal intubation, which is a safe and effective way of preoperative medication.
TRIAL REGISTRATION
ChiCTR-OPN-17010444 . Prospectively registered on 16 January 2017.",2020,"Compared with T0, the values of NE, E, Cor, BS decreased in group D, DP and P at T4, group DP decreased more significantly than group D (p < 0.05).","['Prospectively registered on 16 January 2017', 'patients undergoing functional endoscopic sinus surgery', 'One hundred twenty patients undergoing endoscopic sinus surgery']","['endotracheal intubation', 'dexmedetomidine', 'parecoxib sodium']","['BIS and BP, HR', 'BIS, BP and HR', 'sedation, antianxiety and prevention of intubation stress', 'Ramsay sedation score, BIS value, anxiety score and BP, HR', 'BIS, BP, HR and anxiety scores', 'serum cortisol (Cor), adrenalin (E) norepinephrine (NE) and blood glucose (BS', 'sedation and anxiety and stress response', 'values of NE, E, Cor, BS', 'BP, HR, SPO2', 'changes of Cor, E, NE and BS values', 'blood pressure (BP), heart rate (HR), blood oxygen saturation (SPO2), EEG, bispectral index (BIS), Ramsay sedation score and state anxiety questionnaire (SAI', 'Ramsay sedation score']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0915144', 'cui_str': 'Parecoxib sodium'}]","[{'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",120.0,0.034208,"Compared with T0, the values of NE, E, Cor, BS decreased in group D, DP and P at T4, group DP decreased more significantly than group D (p < 0.05).","[{'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Jinan University, No. 601 West Huangpu Avenue, Tianhe District, Guangzhou City, 510632, Guangdong Province, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': ""Department of Anesthesiology, the Affiliated Hospital of Guangdong Medical University, No. 57 South People's Avenue, Xiashan District, Zhanjiang City, 524001, Guangdong Province, China.""}, {'ForeName': 'Jinxian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, the Affiliated Hospital of Guangdong Medical University, No. 57 South People's Avenue, Xiashan District, Zhanjiang City, 524001, Guangdong Province, China.""}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, the Affiliated Hospital of Guangdong Medical University, No. 57 South People's Avenue, Xiashan District, Zhanjiang City, 524001, Guangdong Province, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Anesthesiology, the Affiliated Hospital of Guangdong Medical University, No. 57 South People's Avenue, Xiashan District, Zhanjiang City, 524001, Guangdong Province, China.""}, {'ForeName': 'Liangqing', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, the Affiliated Hospital of Guangdong Medical University, No. 57 South People's Avenue, Xiashan District, Zhanjiang City, 524001, Guangdong Province, China. gu7450210@163.com.""}]",BMC anesthesiology,['10.1186/s12871-020-01080-0']
1192,32634847,Hemostatic Adaptations to High Intensity Interval Training in Healthy Adult Men.,"Regular exercise is theorized to reduce cardiovascular risk by attenuating coagulation and augmenting fibrinolysis. However, these adaptations have not been consistently observed during traditional exercise programs. The purpose of this study was to examine hemostatic adaptations in healthy men following four (4W) and eight (8W) weeks of high intensity interval training. Twenty-one men (age=25±1 y; body mass index=26.5±6.4 kg/m 2 ) completed eight weeks, three days/week of high intensity interval training on a cycle ergometer. Activated partial thromboplastin time, prothrombin time, and plasma concentrations of thrombin-antithrombin III, fibrinogen, tissue plasminogen activator, and plasminogen activator inhibitor-1 were assessed at baseline (BL), 4W, and 8W. Repeated measures ANOVA were used to determine potential effects of training. There were no significant changes observed for activated partial thromboplastin time (BL=43.3±5.5, 4W=43.2±5.1, 8W=44.2±6.4 s); prothrombin time (BL=13.2±0.9, 4W=13.0±0.6, 8W=13.1±0.8 s); thrombin-antithrombin III (BL=6.0±2.3, 4W=5.8±2.3, 8W=5.6±3.1 ng/mL); tissue plasminogen activator (BL=9.7±3.3, 4W=9.4±3.2, 8W=8.7±2.8 ng/mL); and plasminogen activator inhibitor-1 (BL=19.0±17.5, 4W=19.3±17.0, 8W=18.9±18.9 ng/mL) (all p>0.05). Fibrinogen was significantly lower at 4W (238.6±70.3 mg/dL) compared to BL (285.0±82.1 mg/dL; p<0.05) and 8W (285.3±83.2 mg/dL; p<0.05). These findings indicate that eight weeks of high intensity interval training does not influence coagulation potential and/or stimulate fibrinolysis.",2020,"There were no significant changes observed for activated partial thromboplastin time (BL=43.3±5.5, 4W=43.2±5.1, 8W=44.2±6.4 s); prothrombin time (BL=13.2±0.9, 4W=13.0±0.6, 8W=13.1±0.8 s); thrombin-antithrombin III (BL=6.0±2.3, 4W=5.8±2.3, 8W=5.6±3.1 ng/mL); tissue plasminogen activator (BL=9.7±3.3, 4W=9.4±3.2, 8W=8.7±2.8 ng/mL); and plasminogen activator inhibitor-1 (BL=19.0±17.5, 4W=19.3±17.0, 8W=18.9±18.9 ng/mL) (all p>0.05).","['Twenty-one men (age=25±1\u2009y; body mass index=26.5±6.4\u2009kg/m 2 ', 'Healthy Adult Men', 'healthy men following four (4W) and eight (8W) weeks of high intensity interval training']","['High Intensity Interval Training', 'high intensity interval training on a cycle ergometer', 'Regular exercise']","['activated partial thromboplastin time', 'hemostatic adaptations', 'tissue plasminogen activator', 'plasminogen activator inhibitor-1', 'prothrombin time', 'Activated partial thromboplastin time, prothrombin time, and plasma concentrations of thrombin-antithrombin III, fibrinogen, tissue plasminogen activator, and plasminogen activator inhibitor-1', 'coagulation potential and/or stimulate fibrinolysis', 'thrombin-antithrombin III', 'Fibrinogen']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}]","[{'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}]",21.0,0.0755851,"There were no significant changes observed for activated partial thromboplastin time (BL=43.3±5.5, 4W=43.2±5.1, 8W=44.2±6.4 s); prothrombin time (BL=13.2±0.9, 4W=13.0±0.6, 8W=13.1±0.8 s); thrombin-antithrombin III (BL=6.0±2.3, 4W=5.8±2.3, 8W=5.6±3.1 ng/mL); tissue plasminogen activator (BL=9.7±3.3, 4W=9.4±3.2, 8W=8.7±2.8 ng/mL); and plasminogen activator inhibitor-1 (BL=19.0±17.5, 4W=19.3±17.0, 8W=18.9±18.9 ng/mL) (all p>0.05).","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Sackett', 'Affiliation': 'Integrative Exercise Physiology Laboratory, Ball State University, Muncie, United States.'}, {'ForeName': 'Dan P', 'Initials': 'DP', 'LastName': 'Farrell', 'Affiliation': 'Integrative Exercise Physiology Laboratory, Ball State University, Muncie, United States.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Nagelkirk', 'Affiliation': 'Integrative Exercise Physiology Laboratory, Ball State University, Muncie, United States.'}]",International journal of sports medicine,['10.1055/a-1165-2040']
1193,32634052,A randomized controlled trial to compare group motivational interviewing to very brief advice for the effectiveness of a workplace smoking cessation counseling intervention.,"BACKGROUND
Studies show that smokers have a lower work performance due to time spent smoking, increased fatigue perception and are more absent from work due to smoking-related diseases. The workplace could represent an important location to promote smoking cessation.
METHODS
This study is a multi-center, controlled trial for smoking cessation counseling at the participants' workplace, where 656 randomized participants received four sessions of group motivational interviewing or four sessions of very brief advice and were followed up for 52 weeks.
RESULTS
The Continuous Quit Rate (CQR) was higher for the smoking cessation counseling group than for the very brief advice group during weeks 9 to 12 (17.5% vs. 3.6%) weeks 9 to 24 (13.4% vs. 3.4%) and weeks 9 to 52 (10.3% vs. 3.1%).
CONCLUSIONS
This study demonstrated that motivational interviewing is an efficacious smoking cessation approach for smokers at their workplace. The short-term and long-term cessation rate of the intervention of the smoking cessation counseling group exceeded that of very brief advice.",2020,The Continuous Quit Rate (CQR) was higher for the smoking cessation counseling group than for the very brief advice group during weeks 9 to 12 (17.5% vs. 3.6%) weeks,['smokers at their workplace'],"['workplace smoking cessation counseling intervention', 'motivational interviewing', 'smoking cessation counseling']",['Continuous Quit Rate (CQR'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}]",656.0,0.0260156,The Continuous Quit Rate (CQR) was higher for the smoking cessation counseling group than for the very brief advice group during weeks 9 to 12 (17.5% vs. 3.6%) weeks,"[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Caponnetto', 'Affiliation': '""Centro per la Prevenzione e Cura del Tabagismo - CPCT"", Center of Excellence for the acceleration of Harm Reduction - CoEHAR, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Maglia', 'Affiliation': '""Centro per la Prevenzione e Cura del Tabagismo - CPCT"", Center of Excellence for the acceleration of Harm Reduction - CoEHAR, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Floresta', 'Affiliation': 'Health and Safety Manager of Eurospin Sicily and Calabria, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Ledda', 'Affiliation': 'Occupational Medicine, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Ermanno', 'Initials': 'E', 'LastName': 'Vitale', 'Affiliation': 'Occupational Medicine, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Polosa', 'Affiliation': '""Centro per la Prevenzione e Cura del Tabagismo - CPCT"", Center of Excellence for the acceleration of Harm Reduction - CoEHAR, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Venerando', 'Initials': 'V', 'LastName': 'Rapisarda', 'Affiliation': 'Occupational Medicine, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}]",Journal of addictive diseases,['10.1080/10550887.2020.1782564']
1194,32645162,Patterns of Antiretroviral Therapy Use and Immunologic Profiles at Enrollment in the REPRIEVE Trial.,"BACKGROUND
Patterns of antiretroviral therapy (ART) use and immunologic correlates vary globally, and contemporary trends are not well described.
METHODS
The REPRIEVE trial (Randomized Trial to Prevent Vascular Events in HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk. ART use was summarized within Global Burden of Disease (GBD) super-regions, with adjusted linear and logistic regression analyses examining associations with immune parameters and key demographics.
RESULTS
A total of 7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers. The median CD4 T-cell count was 620/µL (interquartile range, 447-826/ µ L), and the median duration of prior ART use, 9.5 years (5.3-14.8) years. The most common ART regimens were nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI) plus nonnucleoside reverse-transcriptase inhibitor (43%), NRTI plus integrase strand transfer inhibitor (25%), and NRTI plus protease inhibitor (19%). Entry ART varied by GBD region, with shifts during the trial enrollment period. In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
CONCLUSIONS
There were substantial variations in ART use by geographic region and over time, likely reflecting the local availability of specific medications, changes in treatment guidelines and provider/patient preferences. The analyses of CD4 cell counts and CD4/CD8 ratios may provide valuable insights regarding immune correlates and outcomes in people living with HIV.
CLINICAL TRIALS REGISTRATION
NCT02344290.",2020,"In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
","['HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk', 'people living with HIV', '7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers']",['nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI)\u2005plus nonnucleoside reverse-transcriptase inhibitor'],"['GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts', 'entry CD4 cell count and CD4/CD8 ratio', 'median CD4 T-cell count']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}]","[{'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0028630', 'cui_str': 'Nucleotide'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C4277729', 'cui_str': 'Global Burden of Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",7770.0,0.18883,"In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
","[{'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Fichtenbaum', 'Affiliation': 'Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Leon-Cruz', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Carlos D', 'Initials': 'CD', 'LastName': 'Malvestutto', 'Affiliation': 'Division of Infectious Diseases, Ohio State University Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Kileel', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Van Schalkwyk', 'Affiliation': 'Family Centre for Research with Ubuntu, Division of Adult Infectious Diseases, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Nagalingeswaran', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': 'Infectious Diseases Medical Centre, Voluntary Health Services, Chennai, India.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Hospital Clinic and University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Breno Riegel', 'Initials': 'BR', 'LastName': 'Santos', 'Affiliation': 'Infectious Diseases Service, Hospital Nossa, Senhora da Conceição/GHC, Porto Alegre, Brazil.'}, {'ForeName': 'Yvetot', 'Initials': 'Y', 'LastName': 'Joseph', 'Affiliation': 'Les Centres GHESKIO, Port-au-Prince, Haiti.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Siminski', 'Affiliation': 'Frontier Science and Technology Foundation, Amherst, Massachusetts, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Melbourne', 'Affiliation': 'HIV Medical Sciences, Gilead Sciences, Foster City, California, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Sponseller', 'Affiliation': 'Kowa Pharmaceuticals America, Montgomery, Alabama, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung and Blood Institute, Baltimore, Maryland, USA.'}, {'ForeName': 'Gerald S', 'Initials': 'GS', 'LastName': 'Bloomfield', 'Affiliation': 'Department of Medicine, Duke Global Health Institute and Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, University of California-Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiaa259']
1195,32654395,A pilot randomized controlled trial comparing online versus face-to-face delivery of an aphasia communication partner training program for student healthcare professionals.,"BACKGROUND
Training conversation partners of people with aphasia who use facilitative communication strategies is one method that can improve access to healthcare for people with aphasia. However, the efficacy of communication partner training (CPT) has been investigated almost exclusively in the context of face-to-face (F2F) delivery. Online training may offer more cost-effective and accessible options to a wider range of conversation partners, including student healthcare professionals.
AIMS
To conduct a pilot randomized controlled trial with student healthcare professionals comparing (1) an online aphasia CPT program, (2) a F2F CPT program and (3) no program (control group) on outcomes relating to attitudes and knowledge of aphasia.
METHODS & PROCEDURES
A 45-min introductory aphasia CPT program was developed using the theories and techniques of Supported Conversations for Adults with Aphasia (SCA)™. A total of 30 first-year undergraduates studying occupational therapy at The University of Sydney were randomly allocated to one of three conditions: online CPT delivery, F2F delivery or delayed training control (no program). Outcomes measures included pre-post-testing with the Aphasia Attitudes, Strategies and Knowledge (AASK) survey.
OUTCOMES & RESULTS
A significant difference existed for the AASK survey pre-post-change scores between the online, F2F and control groups (χ 2 (2) = 20.038, p = 0.000). Post-hoc analysis revealed that, compared with the control (Ctrl) group, participants in both the online and F2F groups had significantly higher knowledge of aphasia (Online versus Ctrl: p = 0.000; F2F versus control: p = 0.002), knowledge of facilitative strategies (Online versus Ctrl: p = 0.000; F2F versus Ctrl: p = 0.002), and positive attitudes towards aphasia (Online versus Ctrl: p = 0.031; F2F versus Ctrl: p = 0.032). No significant difference was observed between the online and F2F groups for the Total or any subtotals (p = 1.000).
CONCLUSIONS AND IMPLICATIONS
The results from this pilot randomized controlled trial indicate that online delivery of the 45-min introductory CPT is equally as efficacious as F2F delivery, and thus may be a viable mode of delivery for future aphasia CPT programs. These pilot results pave the way for a larger study that will comprehensively evaluate the efficacy of an online aphasia CPT program for improving attitudes, knowledge and skills in a broad range of student healthcare professionals. What this paper adds What is already known on this subject The efficacy of F2F CPT for aphasia is well established. Online delivery of CPT programs may offer more cost-effective and accessible services when compared with F2F approaches; however, there is a need to explore the efficacy of online programs. What this paper adds to existing knowledge The 45-min online aphasia CPT program was found to be efficacious for improving student healthcare professionals' knowledge and attitudes towards aphasia and communication, and produced equally successful outcomes when compared with F2F delivery. This is the first study to report the efficacy of an online CPT program that is aligned with SCA for use with student healthcare professionals that also uses a self-report outcome measure with validated psychometric properties. What are the potential or actual clinical implications of this work? Online CPT programs may be useful in both clinical and education contexts to support improved efficiency of services and to enhance communication environments for people with aphasia in healthcare contexts.",2020,"No significant difference was observed between the online and F2F groups for the Total or any subtotals (p = 1.000).
","['student healthcare professionals', 'Adults with Aphasia (SCA)™', 'A total of 30 first-year undergraduates studying occupational therapy at The University of Sydney', 'people with aphasia in healthcare contexts']","['online aphasia CPT program', 'online CPT delivery, F2F delivery or delayed training control (no program', 'student healthcare professionals comparing (1) an online aphasia CPT program, (2) a F2F CPT program and (3) no program (control group', 'Online training', 'aphasia communication partner training program', 'online CPT program', 'communication partner training (CPT']","['knowledge of aphasia', 'knowledge of facilitative strategies', 'positive attitudes towards aphasia', 'pre-post-testing with the Aphasia Attitudes, Strategies and Knowledge (AASK) survey']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0449255', 'cui_str': 'Context'}]","[{'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",30.0,0.0452615,"No significant difference was observed between the online and F2F groups for the Total or any subtotals (p = 1.000).
","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Power', 'Affiliation': 'University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Falkenberg', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barnes', 'Affiliation': 'Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Elbourn', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Attard', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Togher', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}]",International journal of language & communication disorders,['10.1111/1460-6984.12556']
1196,32652548,Comment on: The LAPOP trial of laparoscopic or open distal pancreatectomy.,,2020,,[],['laparoscopic or open distal pancreatectomy'],[],[],"[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy'}]",[],,0.0272785,,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ""Department of Biliary Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': ""Department of Biliary Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Peng', 'Affiliation': ""Department of Biliary Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}]",The British journal of surgery,['10.1002/bjs.11776']
1197,32654663,Hypophosphatemia after high-dose iron repletion with ferric carboxymaltose and ferric derisomaltose-the randomized controlled HOMe aFers study.,"BACKGROUND
In patients with iron deficiency anemia, ferric carboxymaltose (FCM) and ferric derisomaltose (FDI) allow high-dose iron repletion. While FCM is reported to induce hypophosphatemia, the frequency of hypophosphatemia after an equivalent dosage of FDI had not been assessed prospectively.
METHODS
In the prospective, single-center, double-blind HOMe aFers study, 26 women with iron deficiency anemia (hemoglobin < 12 g/dL plus either plasma ferritin ≤ 100 ng/mL or a plasma ferritin ≤ 300 ng/mL and transferrin saturation (TSAT) ≤ 30%) were randomized to a single intravenous infusion of 20 mg/kg body weight (up to a maximum of 1000 mg) FCM or FDI. The primary endpoint was the incidence of hypophosphatemia (plasma phosphorus levels < 2.0 mg/dL at day 1, day 7 ± 2, and/or day 35 ± 2 after the infusion). In order to investigate potential skeletal and cardiovascular implications, we assessed changes in other components of mineral and bone metabolism, left ventricular function, and arrhythmias.
RESULTS
Hypophosphatemia occurred more frequently in women treated with FCM (9 out of 12 [75%]) than in those treated with FDI (1 out of 13 [8%]; p = 0.001). Within 24 h after iron supplementation, women in the FCM group had significant higher plasma intact FGF23 (p < 0.001) and lower plasma 1.25-dihydroxyvitamin D (p < 0.001). As an indicator of urinary phosphorus losses, urinary fractional phosphorus excretion was higher in the FCM group (p = 0.021 at day 7 ± 2 after iron supplementation). We did not observe differences in skeletal and cardiovascular markers, potentially because of the limited number of participants.
CONCLUSIONS
While both FCM and FDI provide efficient iron repletion in participants with iron deficiency anemia, FCM induced hypophosphatemia more often than FDI.
TRIAL REGISTRATION
Clinical Trials.gov NCT02905539. Registered on 8 September 2016. 2015-004808-36 (EudraCT Number) U1111-1176-4563 (WHO Universal Trial Number) DRKS00010766 (Deutsches Register Klinischer Studien).",2020,"RESULTS
Hypophosphatemia occurred more frequently in women treated with FCM (9 out of 12 [75%]) than in those treated with FDI (1 out of 13 [8%]; p = 0.001).","['participants with iron deficiency anemia, FCM induced hypophosphatemia more often than FDI', 'U1111-1176-4563 ', '2015-004808-36 (EudraCT Number', '26 women with iron deficiency anemia (hemoglobin <\u200912\u2009g/dL plus either plasma ferritin ≤\u2009100\u2009ng/mL or a plasma ferritin ≤\u2009300\u2009ng/mL and transferrin saturation (TSAT)\u2009≤\u200930', 'patients with iron deficiency anemia, ferric carboxymaltose (FCM) and ferric derisomaltose (FDI) allow high-dose iron repletion']","['FCM', 'single intravenous infusion of 20\u2009mg/kg body weight (up to a maximum of 1000\u2009mg) FCM or FDI', 'ferric carboxymaltose', 'FCM and FDI']","['plasma intact FGF23', 'incidence of hypophosphatemia (plasma phosphorus levels', 'Hypophosphatemia', 'lower plasma 1.25-dihydroxyvitamin D', 'skeletal and cardiovascular markers', 'mineral and bone metabolism, left ventricular function, and arrhythmias', 'urinary phosphorus losses, urinary fractional phosphorus excretion']","[{'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1318183', 'cui_str': '12G'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}]","[{'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0560741', 'cui_str': 'mg/kg body weight'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C3272931', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0012328', 'cui_str': 'Dihydroxyvitamins D'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C1977907', 'cui_str': 'Fractional excretion of phosphate'}]",26.0,0.501746,"RESULTS
Hypophosphatemia occurred more frequently in women treated with FCM (9 out of 12 [75%]) than in those treated with FDI (1 out of 13 [8%]; p = 0.001).","[{'ForeName': 'I E', 'Initials': 'IE', 'LastName': 'Emrich', 'Affiliation': 'Internal Medicine III-Cardiology, Angiology and Intensive Care Medicine, Saarland University Medical Center, Homburg, Germany. insa.emrich@uks.eu.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lizzi', 'Affiliation': 'Internal Medicine IV-Nephrology and Hypertension, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Siegel', 'Affiliation': 'Internal Medicine IV-Nephrology and Hypertension, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Seiler-Mussler', 'Affiliation': 'Internal Medicine IV-Nephrology and Hypertension, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ukena', 'Affiliation': 'Internal Medicine III-Cardiology, Angiology and Intensive Care Medicine, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kaddu-Mulindwa', 'Affiliation': 'Internal Medicine I-Hematology and Oncology, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': ""D'Amelio"", 'Affiliation': 'Internal Medicine IV-Nephrology and Hypertension, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wagenpfeil', 'Affiliation': 'Institute for Medical Biometry, Epidemiology and Medical Informatics, University Medical Center, Saarland University, Campus Homburg, Homburg, Germany.'}, {'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Brandenburg', 'Affiliation': 'Department of Cardiology and Nephrology, Rhein-Maas Klinikum, Würselen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Internal Medicine III-Cardiology, Angiology and Intensive Care Medicine, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fliser', 'Affiliation': 'Internal Medicine IV-Nephrology and Hypertension, Saarland University Medical Center, Homburg, Germany.'}, {'ForeName': 'G H', 'Initials': 'GH', 'LastName': 'Heine', 'Affiliation': 'Internal Medicine IV-Nephrology and Hypertension, Saarland University Medical Center, Homburg, Germany. gunnar.heine@uks.eu.'}]",BMC medicine,['10.1186/s12916-020-01643-5']
1198,32659480,Effectiveness of a physiologic voice therapy program based on different semioccluded vocal tract exercises in subjects with behavioral dysphonia: A randomized controlled trial.,"PURPOSE
The present study aimed to assess the effectiveness of a physiologic voice therapy program based on different semioccluded vocal tract exercises in subjects with behavioral dysphonia.
METHODS
Thirty-four participants with behavioral dysphonia were randomly assigned to one of two treatment groups: 1) voice treatment with physiologic voice therapy plus vocal hygiene program (n=20), and 2) vocal hygiene program only (n=14). Laryngoscopic assessment was performed in all subjects. Before and after voice therapy, participants underwent aerodynamic, electroglottographic, and acoustic assessment. The Voice Handicap Index (VHI), Voice symptom scale (VoiSs), Vocal tract discomfort scale (VTDS), and self-assessment of resonant voice quality were also performed. The treatment included eight voice therapy sessions. For the experimental group, the exercises consisted of a sequence of seven phonatory tasks performed with four different semioccluded vocal tract exercises (SOVTE). Comparison for all variables were performed between experimental group and control group.
RESULTS
Wilcoxon test showed significant improvements for experimental group for VHI, VoiSs, VTDS (decrease), and self-perception of resonant voice quality (increase). Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
CONCLUSION
Physiologic voice therapy based on semioccluded vocal tract exercises seems to be an effective tool to improve voice in subjects diagnosed with behavioral dysphonia. Apparently, most changes should be expected in variables related to physical and functional aspects compared to objective variables. Subglottic pressure and phonation threshold pressure seem to be the most change-sensitive parameters and they may reflect a reduction in phonatory effort reported by patients after voice therapy.",2020,"Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
","['subjects diagnosed with behavioral dysphonia', 'Thirty-four participants with behavioral dysphonia', 'subjects with behavioral dysphonia']","['physiologic voice therapy program', 'phonatory tasks performed with four different semioccluded vocal tract exercises (SOVTE', 'voice treatment with physiologic voice therapy plus vocal hygiene program (n=20), and 2) vocal hygiene program', 'Physiologic voice therapy']","['VHI, VoiSs, VTDS (decrease), and self-perception of resonant voice quality (increase', 'Subglottic pressure and phonation threshold pressure', 'Laryngoscopic assessment', 'Voice Handicap Index (VHI), Voice symptom scale (VoiSs), Vocal tract discomfort scale (VTDS), and self-assessment of resonant voice quality', 'subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]","[{'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0577554', 'cui_str': 'Resonant'}, {'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0234833', 'cui_str': 'Subglottic pressure'}, {'cui': 'C0031577', 'cui_str': 'Laryngeal voice function'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]",34.0,0.0112718,"Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Guzman', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de los Andes, Chile; Department of Otolaryngology, Las Condes Clinic, Santiago, Chile. Electronic address: guzmann.marcoa@gmail.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Bertucci', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: terebertucci@gmail.com.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Pacheco', 'Affiliation': 'Department of Otolaryngology, Las Condes Clinic, Av. Estoril 850, Santiago, Chile. Electronic address: cpachecob@clinicalascondes.cl.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Leiva', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad Pedro de Valdivia, Vicuña Mackena 44, Santiago, Chile. Electronic address: fernando.leiva.solari@gmail.com.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Quintana', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: quintana.b.felipe@gmail.com.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Ansaldi', 'Affiliation': 'Facultad de Ciencias de la Salud, Universidad de las Américas, Santiago, Chile. Electronic address: romina.ansaldi@gmail.com.'}, {'ForeName': 'Camilo', 'Initials': 'C', 'LastName': 'Quezada', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: cequezad@uc.cl.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Department of Otolaryngology, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: daniel.uchile@gmail.com.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106023']
1199,32675598,"Postoperative Single-shot Epidural Fentanyl and Bupivacaine for Postoperative Analgesia After Lumbar Decompression: A Prospective, Double-blind Randomized Study.","STUDY DESIGN
Randomized clinical trial.
OBJECTIVE
To evaluate the efficacy of the postoperative single-shot bolus of epidural Fentanyl and Bupivicaine in providing pain relief postlumbar decompression surgery.
SUMMARY OF BACKGROUND DATA
Despite lumbar decompression's success in alleviating symptoms of sciatica, radiculopathy, and neurogenic claudication, transient back and buttock pain has been a common complaint postoperatively. Providing good postoperative pain alleviation predicts patient's quality of recovery.
METHODS
We performed a randomized, double-blinded, clinical trial. Forty-five patients scheduled for lumbar decompression for a year's period who were randomly assigned to receive a postoperative bolus of 10-mL solution of 50 mcg of Fentanyl, 0.125% Bupivacaine, and 0.9% saline solution via an intraoperatively placed epidural catheter immediately after wound closure, before dressing application. Facial pain scale scores (from 0 to 10) were measured at three time points after surgery (fully awake at recovery room, transfer to ward, first postoperative day). Postoperative need for oral analgesics, time to independent ambulation, associated adverse events, and time to hospital discharge were also evaluated.
RESULTS
Pain scores were noted to be significantly lower at all time points in the epidural group (P < 0.001). In turn, they also received less on-demand oral pain medications than those in the control group (P = 0.000). The mean time to ambulation was 0.09 days in the epidural group and 0.91 days in the decompression-alone group (P = 0.000). Criteria for hospital discharge were usually met on Day 0 in the epidural and Day 1 in the control group (P = 0.000). Within the study period, only one infection was noted in the epidural group which necessitated additional lumbar spine surgery (4.3%). No adverse events or complications related to Fentanyl use were observed.
CONCLUSIONS
A postoperative bolus of Fentanyl and Bupivacaine is effective in reducing early postoperative pain without the related complications of opiod administration.
LEVEL OF EVIDENCE
2.",2020,"RESULTS
Pain scores were noted to be significantly lower at all time points in the epidural group (P < 0.001).","[""Forty-five patients scheduled for lumbar decompression for a year's period""]","['Postoperative Single-shot Epidural Fentanyl and Bupivacaine', 'Fentanyl and Bupivacaine', 'epidural Fentanyl and Bupivicaine', 'postoperative bolus of 10-mL solution of 50 mcg of Fentanyl, 0.125% Bupivacaine, and 0.9% saline solution']","['mean time to ambulation', 'Facial pain scale scores', 'Postoperative Analgesia', 'Postoperative need for oral analgesics, time to independent ambulation, associated adverse events, and time to hospital discharge', 'demand oral pain medications', 'early postoperative pain', 'additional lumbar spine surgery', 'Criteria for hospital discharge', 'Pain scores']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C4517427', 'cui_str': '0.125'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0221776', 'cui_str': 'Painful mouth'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0408578', 'cui_str': 'Operation on lumbar spine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",45.0,0.505371,"RESULTS
Pain scores were noted to be significantly lower at all time points in the epidural group (P < 0.001).","[{'ForeName': 'Mannuel Feliciano B', 'Initials': 'MFB', 'LastName': 'Alican', 'Affiliation': ""Institute of Orthopedics and Sports Medicine, St. Luke's Medical Center, Quezon City, Philippines.""}, {'ForeName': 'Mario R', 'Initials': 'MR', 'LastName': 'Ver', 'Affiliation': ""Institute of Orthopedics and Sports Medicine, St. Luke's Medical Center, Quezon City, Philippines.""}, {'ForeName': 'Miguel Rafael D', 'Initials': 'MRD', 'LastName': 'Ramos', 'Affiliation': ""Institute of Orthopedics and Sports Medicine, St. Luke's Medical Center, Quezon City, Philippines.""}, {'ForeName': 'Lulu Joan C', 'Initials': 'LJC', 'LastName': 'Mamaril', 'Affiliation': ""Department of Anesthesiology, St. Luke's Medical Center, Quezon City, Philippines.""}]",Spine,['10.1097/BRS.0000000000003449']
1200,32675599,"The Titanium-coated PEEK Cage Maintains Better Bone Fusion With the Endplate Than the PEEK Cage 6 Months After PLIF Surgery: A Multicenter, Prospective, Randomized Study.","STUDY DESIGN
A multicenter, randomized, open-label, parallel-group trial.
OBJECTIVE
To investigate interbody bone fusion rates in titanium-coated polyetheretherketone (TiPEEK) and polyetheretherketone (PEEK) cages after posterior lumbar interbody fusion (PLIF) surgery.
SUMMARY OF BACKGROUND DATA
Previous clinical studies have not revealed any significant difference in bone fusion rates between TiPEEK and PEEK cages.
METHODS
During one-level PLIF surgery, 149 patients (84 men, 65 women, mean age 67 yr) were randomly allocated to use either a TiPEEK cage (n = 69) or PEEK cage (n = 80). Blinded radiographic evaluations were performed using computed tomography and assessed by modified intention-to-treat analysis in 149 cases and per-protocol analysis in 143 cases who were followed for 12 months. Clinical outcomes were assessed using the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and the Oswestry Disability Index.
RESULTS
The interbody union rate at 12 months after surgery was 45% owing to a very strict definition of bone fusion. The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted modified intention-to-treat analysis and were significantly higher at 6 months in the unadjusted per-protocol analysis. Binary logistic regression analysis adjusted for sex, age, body mass index, bone mineral density, and surgical level showed that using a TiPEEK cage (odds ratio, 2.27; 95% confidence interval: 1.09-4.74; P = 0.03) was independently associated with bone fusion at 6 months after surgery. Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and Oswestry Disability Index results improved postoperatively in both groups.
CONCLUSION
Using the TiPEEK cage for PLIF enabled the maintenance of better bone fusion to the endplate than using the PEEK cage at 6 months after the surgery. Our findings suggest the possibility of an earlier return to rigorous work or sports by the use of TiPEEK cage.
LEVEL OF EVIDENCE
1.",2020,The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted modified intention-to-treat analysis and were significantly higher at 6 months in the unadjusted per-protocol analysis.,"['149 patients (84 men, 65 women, mean age 67 yr']","['titanium-coated polyetheretherketone (TiPEEK) and polyetheretherketone (PEEK) cages', 'TiPEEK cage (n\u200a=\u200a69) or PEEK cage']","['interbody union rate', 'rates of bone fusion', 'Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and Oswestry Disability Index', 'Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and the Oswestry Disability Index', 'bone fusion rates']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0337189', 'cui_str': 'Cage'}]","[{'cui': 'C0185364', 'cui_str': 'Osteoplasty'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",149.0,0.0990922,The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted modified intention-to-treat analysis and were significantly higher at 6 months in the unadjusted per-protocol analysis.,"[{'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ushirozako', 'Affiliation': 'Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Ebata', 'Initials': 'E', 'LastName': 'Shigeto', 'Affiliation': 'Department of Orthopedic Surgery, University of Yamanashi, Chuo, Yamanashi, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Ohba', 'Affiliation': 'Department of Orthopedic Surgery, University of Yamanashi, Chuo, Yamanashi, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Oba', 'Affiliation': 'Department of Orthopedic Surgery, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Mukaiyama', 'Affiliation': 'Department of Orthopedic Surgery, North Alps Medical Center Azumi Hospital, Kita Azumi, Nagano, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Shimizu', 'Affiliation': 'Department of Orthopedic Surgery, Narita Memorial Hospital, Aichi, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yamato', 'Affiliation': 'Department of Orthopedic Surgery and Division of Geriatric Musculoskeletal Health, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Ide', 'Affiliation': 'Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Shibata', 'Affiliation': 'Department of Community Health and Preventive Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Ojima', 'Affiliation': 'Department of Community Health and Preventive Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takahashi', 'Affiliation': 'Department of Orthopedic Surgery, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Haro', 'Affiliation': 'Department of Orthopedic Surgery, University of Yamanashi, Chuo, Yamanashi, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}]",Spine,['10.1097/BRS.0000000000003464']
1201,32675601,Prosthesis in Anterior Cervical Herniated Disc Approach Does Not Prevent Radiologic Adjacent Segment Degeneration.,"STUDY DESIGN
Retrospective analysis using data from RCTs.
OBJECTIVE
This study aimed to report on the incidence of radiological adjacent segment degeneration (ASD) in patients with cervical radiculopathy due to a herniated disc that were randomized to receive cervical arthroplasty or arthrodesis.
SUMMARY OF BACKGROUND DATA
Cervical disc prostheses were introduced to prevent ASD in the postsurgical follow-up. However, it is still a controversial issue.
METHODS
Two hundred fifty-three patients were included in two randomized, double-blinded trials comparing anterior cervical discectomy with arthroplasty (ACDA), with intervertebral cage (ACDF), or without intervertebral cage (ACD) for one-level disc herniation. Neutral lateral radiographs were obtained preoperatively, at 1- and 2-year follow-up after surgery. Radiological ASD was evaluated on X-ray and defined by a decrease in disc height and the presence of anterior osteophyte formation on both the superior and the inferior level in relation to the target level.
RESULTS
Radiological ASD was present in 34% of patients at baseline and increased to 59% at 2-year follow-up in the arthrodesis groups (ACD and ACDF combined), and to 56% in the arthroplasty group. Progression of radiological ASD was present in 29% of patients in the arthrodesis group and in 31% of patients in the arthroplasty group for 2-year follow-up.
CONCLUSIONS
Radiological ASD occurs in a similar manner in patients who were subjected to arthrodesis in cervical radiculopathy and in patients who received arthroplasty to maintain motion. Current data tend to indicate that the advantage of cervical prosthesis in preventing radiological ASD is absent.
LEVEL OF EVIDENCE
2.",2020,"Progression of radiological ASD was present in 29% of patients in the arthrodesis group and in 31% of patients in the arthroplasty group for 2-year follow-up.
","['Two hundred fifty-three patients', 'patients with cervical radiculopathy due to a herniated disc']","['anterior cervical discectomy with arthroplasty (ACDA), with intervertebral cage (ACDF), or without intervertebral cage (ACD', 'cervical arthroplasty or arthrodesis']","['disc height', 'Progression of radiological ASD', 'Radiological ASD']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0742186', 'cui_str': 'Cervical radiculopathy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0442106', 'cui_str': 'Intervertebral'}, {'cui': 'C0337189', 'cui_str': 'Cage'}, {'cui': 'C0002873', 'cui_str': 'Anemia of chronic disease'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0003881', 'cui_str': 'Arthrodesis'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C3888829', 'cui_str': 'Adjacent segment degeneration'}]",253.0,0.151115,"Progression of radiological ASD was present in 29% of patients in the arthrodesis group and in 31% of patients in the arthroplasty group for 2-year follow-up.
","[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Donk', 'Affiliation': 'Department of Orthopaedic Surgery, Via Sana Clinics, Mill, The Netherlands.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Arts', 'Affiliation': 'Department of Neurosurgery, Haaglanden Medical Centre, The Hague, The Netherlands.'}, {'ForeName': 'Ronald H M A', 'Initials': 'RHMA', 'LastName': 'Bartels', 'Affiliation': 'Department of Neurosurgery, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Carmen L A', 'Initials': 'CLA', 'LastName': 'Vleggeert-Lankamp', 'Affiliation': 'Department of Neurosurgery, Leiden University Medical Centre, Leiden, The Netherlands.'}]",Spine,['10.1097/BRS.0000000000003453']
1202,32677987,Establishing cross-systems collaborations for implementation: protocol for a longitudinal mixed methods study.,"BACKGROUND
Cross-system interventions can help integrate services across different service delivery systems but require organizations to establish strong collaborative relationships for implementation. Contingency theory suggests that the effectiveness of different collaborative strategies (i.e. specific ways organizations align operations and services) varies by context. This paper describes a study of different strategies for fostering collaboration between child welfare and substance abuse treatment agencies and the conditions under which they are effective for implementation. We also describe the development and piloting of the Collaborating Across Systems for Program Implementation (CASPI) tool-a decision-making guide intended to help researchers and organizational leaders identify and use appropriate collaborative strategies for their context.
METHODS/DESIGN
This multisite longitudinal, mixed methods study, leverages a naturally occurring implementation initiative -- in up to 17 Ohio counties -- to implement Ohio START (Sobriety Treatment and Reducing Trauma). START is a child welfare model that requires strong collaboration with local substance use treatment organizations to promote integrated services. During the first two years, we will identify collaborative strategies associated with improved START implementation (penetration and fidelity) and service delivery outcomes (timeliness), given system, and organizational features. We will conduct a convergent mixed methods study drawing on worker surveys, agency documents, administrative data, formal partner agreements, and group interviews. Data will be integrated and analyzed using Qualitative Comparative Analysis (QCA). To develop the CASPI, an expert panel comprised of implementation experts, and community stakeholders will convene to synthesize our findings and develop contents (including a decision tree). During the final year of the study, we will assess the acceptability, appropriateness, and feasibility of the CASPI in a randomized vignette experiment, and a pilot-test with 3 child welfare agencies that have not yet implemented START.
DISCUSSION
Our results will lay the groundwork for a larger controlled trial that will test the CASPI's effectiveness for supporting effective and efficient implementation of cross-system interventions like START. The CASPI is expected to help leaders and researchers select and use collaboration strategies tailored to their context and be applicable in a wide range of settings including rural communities. Our work also advances system-level implementation strategies.
TRIAL REGISTRATION
NCT03931005 , Registered April 29, 2019.",2020,"During the first two years, we will identify collaborative strategies associated with improved START implementation (penetration and fidelity) and service delivery outcomes (timeliness), given system, and organizational features.",['leverages a naturally occurring implementation initiative -- in up to 17 Ohio counties -- to implement Ohio START (Sobriety Treatment and Reducing Trauma'],[],"['START implementation (penetration and fidelity) and service delivery outcomes (timeliness), given system, and organizational features']","[{'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]",[],"[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",,0.0363623,"During the first two years, we will identify collaborative strategies associated with improved START implementation (penetration and fidelity) and service delivery outcomes (timeliness), given system, and organizational features.","[{'ForeName': 'Alicia C', 'Initials': 'AC', 'LastName': 'Bunger', 'Affiliation': 'College of Social Work, The Ohio State University, 1947 College Road, Columbus, OH, 43210, USA. Bunger.5@osu.edu.'}, {'ForeName': 'Emmeline', 'Initials': 'E', 'LastName': 'Chuang', 'Affiliation': 'School of Social Welfare, University of California Berkeley, 120 Haviland Hall, Berkeley, CA, 94720, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Girth', 'Affiliation': 'John Glenn College of Public Affairs, The Ohio State University, 1810 College Road, Columbus, OH, 43210, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lancaster', 'Affiliation': 'College of Public Health, The Ohio State University, 1841 Neil Avenue, Columbus, OH, 43210, USA.'}, {'ForeName': 'Fawn', 'Initials': 'F', 'LastName': 'Gadel', 'Affiliation': 'Public Children Services Association of Ohio (PCSAO), 37 West Broad Street, Suite 1100, Columbus, OH, 43215, USA.'}, {'ForeName': 'Marla', 'Initials': 'M', 'LastName': 'Himmeger', 'Affiliation': 'Public Children Services Association of Ohio (PCSAO), 37 West Broad Street, Suite 1100, Columbus, OH, 43215, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Saldana', 'Affiliation': 'Oregon Social Learning Center, 10 Shelton McMurphey Blvd., Eugene, OR, 97405, USA.'}, {'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Powell', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Aarons', 'Affiliation': 'UC San Diego, Department of Psychiatry, 9500 Gilman Drive (0812), La Jolla, San Diego, CA, 92093, USA.'}]",Implementation science : IS,['10.1186/s13012-020-01016-9']
1203,32673233,Efficacy of a Guided Web-Based Self-Management Intervention for Depression or Dysthymia: Randomized Controlled Trial With a 12-Month Follow-Up Using an Active Control Condition.,"BACKGROUND
An increasing number of studies suggest that web-based interventions for patients with depression can reduce their symptoms and are expected to fill currently existing treatment gaps. However, evidence for their efficacy has mainly been derived from comparisons with wait-list or treatment as usual controls. In particular, designs using wait-list controls are unlikely to induce hope and may even have nocebo effects, making it difficult to draw conclusions about the intervention's efficacy. Studies using active controls are rare and have not yielded conclusive results.
OBJECTIVE
The main objective of this study is to assess the acute and long-term antidepressant efficacy of a 6-week, guided, web-based self-management intervention building on the principles of cognitive behavioral therapy (iFightDepression tool) for patients with depression compared with web-based progressive muscle relaxation as an active control condition.
METHODS
A total of 348 patients with mild-to-moderate depressive symptoms or dysthymia (according to the Mini International Neuropsychiatric Interview) were recruited online and randomly assigned to 1 of the 2 intervention arms. Acute antidepressant effects after 6 weeks and long-term effects at 3-, 6-, and 12-month follow-up were studied using the Inventory of Depressive Symptomatology-self-rating as a primary outcome parameter and change in quality of life (Short Form 12) and user satisfaction (client satisfaction questionnaire) as secondary outcome parameters. Treatment effects were assessed using mixed model analyses.
RESULTS
Over the entire observation period, a greater reduction in symptoms of depression (P=.01) and a greater improvement of life quality (P<.001) was found in the intervention group compared with the active control group. Separate tests for each time point revealed significant effects on depressive symptoms at the 3-month follow-up (d=0.281; 95% CI 0.069 to 0.493), but not after 6 weeks (main outcome:d=0.192; 95% CI -0.020 to 0.404) and 6 and 12 months. The intervention was significantly superior to the control condition with respect to user satisfaction (25.31 vs 21.97; t 259 =5.804; P<.01).
CONCLUSIONS
The fact that antidepressant effects have been found for a guided self-management tool in comparison with an active control strengthens the evidence base for the efficacy of web-based interventions. The antidepressant effect became most prominent at the 3-month follow-up. After 6 weeks of intervention, significant positive effects were observed on life quality but not on depressive symptoms. Although the effect size of such web-based interventions on symptoms of depression might be smaller than that suggested by earlier studies using wait-list control conditions, they can be a cost-effective addition to antidepressants and face-to-face psychotherapy.
TRIAL REGISTRATION
International Clinical Trials Registry Platform ICTRP080-15-09032015; https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00009323.",2020,"Over the entire observation period, a greater reduction in symptoms of depression (P=.01) and a greater improvement of life quality (P<.001) was found in the intervention group compared with the active control group.","['patients with depression', '348 patients with mild-to-moderate depressive symptoms or dysthymia (according to the Mini International Neuropsychiatric Interview', 'patients with depression compared with web-based progressive muscle relaxation as an active control condition', 'Depression or Dysthymia']","['Guided Web-Based Self-Management Intervention', 'cognitive behavioral therapy (iFightDepression tool']","['Acute antidepressant effects', 'symptoms of depression', 'life quality', 'quality of life (Short Form 12) and user satisfaction (client satisfaction questionnaire', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",348.0,0.133249,"Over the entire observation period, a greater reduction in symptoms of depression (P=.01) and a greater improvement of life quality (P<.001) was found in the intervention group compared with the active control group.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Oehler', 'Affiliation': 'German Depression Foundation, Leipzig, Germany.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Görges', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Rogalla', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rummel-Kluge', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hegerl', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Goethe-Universität Frankfurt, Frankfurt, Germany.'}]",Journal of medical Internet research,['10.2196/15361']
1204,32686996,"Effects of two exercise programmes on joint position sense, dynamic balance and countermovement jump in male amateur football players. A randomised controlled trial.","Introduction : The injury prevention and warm-up exercises programmes improve physical performance and injury ratio, but it is poorly investigated in amateur football. Objectives : To assess the effects of two warm-up multi-station programmes (IAI-Programme and FIFA11+) through JPS, LSDT and CMJ. Study design: Randomised controlled trial. Methods : 36 football players were randomised into 2 groups: IAI-Programme (n = 18) and FIFA11+ (n = 18) and performed the intervention protocol for 6 weeks. JPS, LSDT and CMJ were measured at baseline, after 6, 10 and 18 weeks (from baseline). The inter-group and intra-group differences were assessed by repeated-measures analysis of variance test (ANOVA). Results : Significant differences between groups were found after 18 weeks in the absolute angular error (-2.18[-4.33,-0.047], d = 0.69, p < 0.05) of the JPS and in the CMJ (p = 0.001, ŋ 2 p=,0.298) in favour of IAI-Programme when compared to FIFA11 +. No significant differences between groups were found in the LSDT. There were also intra-group differences observed in the LSDT in both groups. Conclusions : IAI-Programme can provide sensitive benefits with respect to the proprioceptive ability of knee flexion and CMJ than FIFA11 +. Both IAI-Programme and FIFA11+ present improvements in the dynamic postural control measured by the LSDT.",2020,"RESULTS
Significant differences between groups were found after 18 weeks in the absolute angular error (-2.18[-4.33,-0.047], d = 0.69, p < 0.05) of the JPS and in the CMJ (p = 0.001, ŋ 2 p=,0.298) in favour of IAI-Programme when compared to FIFA11 +.","['36 football players', 'male amateur football players']","['IAI-Programme (n\xa0=\xa018) and FIFA11', 'JPS, LSDT and CMJ', 'exercise programmes']","['dynamic postural control', 'absolute angular error', 'JPS, LSDT and CMJ', 'joint position sense, dynamic balance and countermovement jump', 'physical performance and injury ratio']","[{'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0345893', 'cui_str': 'Juvenile polyposis syndrome'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0345893', 'cui_str': 'Juvenile polyposis syndrome'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.082265,"RESULTS
Significant differences between groups were found after 18 weeks in the absolute angular error (-2.18[-4.33,-0.047], d = 0.69, p < 0.05) of the JPS and in the CMJ (p = 0.001, ŋ 2 p=,0.298) in favour of IAI-Programme when compared to FIFA11 +.","[{'ForeName': 'Marcos J', 'Initials': 'MJ', 'LastName': 'Navarro-Santana', 'Affiliation': 'Health and Rehabilitation Center San Fernando (Centro Médico Rehabilitación San Fernando) , Madrid, Spain.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Asín-Izquierdo', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, University of Alcalá , Madrid, Spain.'}, {'ForeName': 'Guido F', 'Initials': 'GF', 'LastName': 'Gómez-Chiguano', 'Affiliation': 'Podiatry University Clinic, Complutense University of Madrid , Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Albert-Lucena', 'Affiliation': 'Mutua Universal , Madrid, Spain.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Plaza-Manzano', 'Affiliation': 'Department of Radiology, Rehabilitation and Physiotherapy, Complutense University of Madrid , Madrid, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Pérez-Silvestre', 'Affiliation': 'Centre for Sports Medicine, Spanish Agency for Health Protection in Sports (AEPSAD in its Spanish acronym) , Madrid, Spain.'}]",Journal of sports sciences,['10.1080/02640414.2020.1794472']
1205,33066130,"Designing an Effective Front-of-Package Warning Label for Food and Drinks High in Added Sugar, Sodium, or Saturated Fat in Colombia: An Online Experiment.","Policies to require warnings on the front of food and drinks high in nutrients of concern (e.g., added sugar, sodium, or saturated fat) are becoming increasingly common as an obesity prevention strategy. Colombia, a country with growing prevalence of obesity, is considering implementing a similar policy. The objective of this study was to assess perceptions and reactions to different warning designs. We conducted a randomized experiment in an online panel of adults age > 18y ( n = 1997). Participants were randomized to view one of four labels: a control label (barcode), an octagon warning, a circle warning, and a triangle warning. Participants viewed their randomly assigned label on a series of products and answered questions (continuous outcomes ranged from 1-4). Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions, p < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions, p < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions, p < 0.001). Relative to the control, warnings performed similarly across education levels, suggesting this policy would be equitable in Colombia. Looking at differences by warning type, the pattern of results suggested that the octagon warnings performed best. After viewing all label types, 49% of participants selected the octagon warning as the one that most discouraged them from consuming products high in nutrients of concern, while 21% and 27% selected the circle and triangle warning. Colombian policymakers should consider the octagon warning as part of a front-of-package labeling policy to help consumers identify and reduce consumption of foods and drinks high in nutrients of concern.",2020,"Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions, p < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions, p < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions, p < 0.001).",['online panel of adults age '],"['control label (barcode), an octagon warning, a circle warning, and a triangle warning']",['message effectiveness'],"[{'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0350172,"Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions, p < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions, p < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions, p < 0.001).","[{'ForeName': 'Lindsey Smith', 'Initials': 'LS', 'LastName': 'Taillie', 'Affiliation': 'Carolina Population Center and Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, Lineberger Comprehensive Cancer Center, Carolina Population Center, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Luis Fernando', 'Initials': 'LF', 'LastName': 'Gómez', 'Affiliation': 'Facultad de Medicina, Pontificia Universidad Javeriana, 110231 Bogotá, Colombia.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Higgins', 'Affiliation': 'Carolina Population Center, University of North Carolina, Chapel Hill, NC 27516, USA.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Bercholz', 'Affiliation': 'Carolina Population Center, University of North Carolina, Chapel Hill, NC 27516, USA.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Murukutla', 'Affiliation': 'Vital Strategies, New York, NY 27599, USA.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Mora-Plazas', 'Affiliation': 'Departamento de Nutrición Humana, Universidad Nacional de Colombia, 11001 Bogotá, Colombia.'}]",Nutrients,['10.3390/nu12103124']
1206,33066237,"Efficacy and Patient Tolerability Profiles of Probiotic Solution with Bisacodyl Versus Conventional Cleansing Solution for Bowel Preparation: A Prospective, Randomized, Controlled Trial.","Although adequate bowel preparation is essential in screening colonoscopy, patient intolerability to bowel cleansing agents is problematic. Recently, a probiotic mixture solution with bisacodyl emerged to improve patient tolerability. We investigated the efficacy, safety, and patient tolerability profiles of probiotics with bisacodyl versus conventional polyethylene glycol (PEG) solution for bowel preparation for screening colonoscopies in healthy patients in this prospective, randomized, case-control study. In total, 385 volunteers were randomly assigned to receive 2 L of water + 200 mL of probiotic solution (case group, n = 195) or 4 L of PEG solution (control group, n = 190). The efficacy of the bowel cleansing was evaluated using the Ottawa scale system, polyp detection rate, and adenoma detection rate, and the patient tolerability profiles were assessed using a questionnaire. The demographics were not significantly different between groups. When the Ottawa score for each bowel segment was stratified into an adequate vs. inadequate level (Ottawa score ≤ 3 vs. >3), there were no statistical differences between groups in each segment of the colon. There were no significant differences in the polyp and adenoma detection rates between groups (38.42% vs. 32.42, p = 0.30; 25.79% vs. 18.97%, p = 0.11). The case group showed significantly fewer events than the control group, especially nausea, vomiting, and abdominal bloating events. Regarding the overall satisfaction grade, the case group reported significantly more ""average"" scores (95% vs. 44%, p < 0.001) and were more willing to use the same agents again (90.26% vs. 61.85%, p < 0.001). As patient compliance with bowel preparation agents is associated with an adequate level of bowel cleansing, a probiotic solution with bisacodyl might be a new bowel preparation candidate, especially in patients who show a poor compliance with conventional bowel preparation agents.",2020,"There were no significant differences in the polyp and adenoma detection rates between groups (38.42% vs. 32.42, p = 0.30; 25.79% vs. 18.97%, p = 0.11).","['patients who show a poor compliance with conventional bowel preparation agents', '385 volunteers', 'Bowel Preparation', 'healthy patients']","['Probiotic Solution with Bisacodyl Versus Conventional Cleansing Solution', '2 L of water + 200 mL of probiotic solution (case group, n = 195) or 4 L of PEG solution', 'probiotics with bisacodyl versus conventional polyethylene glycol (PEG) solution']","['patient tolerability', 'nausea, vomiting, and abdominal bloating events', 'Ottawa scale system, polyp detection rate, and adenoma detection rate, and the patient tolerability profiles', 'efficacy, safety, and patient tolerability profiles', 'polyp and adenoma detection rates', 'average"" scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0005632', 'cui_str': 'Bisacodyl'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",385.0,0.0465274,"There were no significant differences in the polyp and adenoma detection rates between groups (38.42% vs. 32.42, p = 0.30; 25.79% vs. 18.97%, p = 0.11).","[{'ForeName': 'Youn I', 'Initials': 'YI', 'LastName': 'Choi', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Jong-Joon', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Jun-Won', 'Initials': 'JW', 'LastName': 'Chung', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Kyoung Oh', 'Initials': 'KO', 'LastName': 'Kim', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Yoon Jae', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Jung Ho', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Dong Kyun', 'Initials': 'DK', 'LastName': 'Park', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}, {'ForeName': 'Kwang An', 'Initials': 'KA', 'LastName': 'Kwon', 'Affiliation': 'Gil Medical Center, Department of Gastroenterology, Gachon University College of Medicine, 405-760 1198 Guwol dong, Namdong-gu, Incheon 21565, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9103286']
1207,33066334,"A Randomized, Double-Blinded, Placebo-Controlled, Clinical Study of the Effects of a Nutraceutical Combination (LEVELIP DUO ® ) on LDL Cholesterol Levels and Lipid Pattern in Subjects with Sub-Optimal Blood Cholesterol Levels (NATCOL Study).","Phytosterols and red yeast rice are largely studied cholesterol-lowering nutraceuticals, respectively inhibiting the bowel absorption and liver synthesis of cholesterol. Our aim was to test the effect of combined nutraceutical-containing phytosterols and red yeast rice vs. a placebo on the lipid profile. We performed a parallel arms, double-blind, placebo-controlled clinical trial, randomizing 88 moderately hypercholesterolemic subjects to treatment with a combined nutraceutical containing phytosterols (800 mg) and red yeast rice, standardized to contain 5 mg of monacolins from Monascus purpureus , with added niacin (27 mg) and policosanols (10 mg) (LEVELIP DUO ® ) , or placebo. The mean LDL-Cholesterol (LDL-C) change at Week 8 was -32.5 ± 30.2 mg/dL (-19.8%) in the combined nutraceutical group and 2.5 ± 19.4 mg/dL (2.3%) in the placebo group. The estimated between-group difference of -39.2 mg/dL (95% CI: -48.6; -29.8) indicates a statistically significant difference between treatments in favor of the combined nutraceutical ( p < 0.0001). Total Cholesterol (TC), non-HDL cholesterol (non-HDL-C), Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C improved in a similar way in the combined nutraceutical group only. No significant changes in other clinical and laboratory parameters were observed. In conclusion, the tested combined nutraceutical was well tolerated, while significantly reducing the plasma levels of LDL-C, TC, non-HDL-C, ApoB, TC/HDL-C and LDL-C/HDL-C ratios in mildly hypercholesterolemic patients. Trial registration (ClinicalTrials.gov): NCT03739242.",2020,"Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C improved in a similar way in the combined nutraceutical group only.","['mildly hypercholesterolemic patients', 'Subjects with Sub-Optimal Blood Cholesterol Levels (NATCOL Study', '88 moderately hypercholesterolemic subjects']","['Nutraceutical Combination (LEVELIP DUO ® ', 'combined nutraceutical containing phytosterols (800 mg) and red yeast rice, standardized to contain 5 mg of monacolins from Monascus purpureus , with added niacin (27 mg) and policosanols (10 mg) (LEVELIP DUO ® ) , or placebo', 'combined nutraceutical-containing phytosterols and red yeast rice vs. a placebo', 'placebo', 'Placebo']","['plasma levels of LDL-C, TC, non-HDL-C, ApoB, TC/HDL-C and LDL-C/HDL-C ratios', 'Total Cholesterol (TC), non-HDL cholesterol (non-HDL-C', 'lipid profile', 'Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C', 'mean LDL-Cholesterol (LDL-C) change', 'LDL Cholesterol Levels and Lipid Pattern']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0763533', 'cui_str': 'red yeast rice'}, {'cui': 'C0997449', 'cui_str': 'Monascus purpureus'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0215278', 'cui_str': 'policosanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",88.0,0.389198,"Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C improved in a similar way in the combined nutraceutical group only.","[{'ForeName': 'Arrigo F G', 'Initials': 'AFG', 'LastName': 'Cicero', 'Affiliation': 'Medical an Surgery Sciences Department, Dyslipidemia and Atherosclerosis Research Unit, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': ""D'Addato"", 'Affiliation': 'Medical an Surgery Sciences Department, Dyslipidemia and Atherosclerosis Research Unit, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Borghi', 'Affiliation': 'Medical an Surgery Sciences Department, Dyslipidemia and Atherosclerosis Research Unit, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.'}]",Nutrients,['10.3390/nu12103127']
1208,33068037,Safety and Efficacy of Omaveloxolone in Friedreich Ataxia (MOXIe Study).,"OBJECTIVE
Friedreich ataxia (FA) is a progressive genetic neurodegenerative disorder with no approved treatment. Omaveloxolone, an Nrf2 activator, improves mitochondrial function, restores redox balance, and reduces inflammation in models of FA. We investigated the safety and efficacy of omaveloxolone in patients with FA.
METHODS
We conducted an international, double-blind, randomized, placebo-controlled, parallel-group, registrational phase 2 trial at 11 institutions in the United States, Europe, and Australia (NCT02255435, EudraCT2015-002762-23). Eligible patients, 16 to 40 years of age with genetically confirmed FA and baseline modified Friedreich's Ataxia Rating Scale (mFARS) scores between 20 and 80, were randomized 1:1 to placebo or 150mg per day of omaveloxolone. The primary outcome was change from baseline in the mFARS score in those treated with omaveloxolone compared with those on placebo at 48 weeks.
RESULTS
One hundred fifty-five patients were screened, and 103 were randomly assigned to receive omaveloxolone (n = 51) or placebo (n = 52), with 40 omaveloxolone patients and 42 placebo patients analyzed in the full analysis set. Changes from baseline in mFARS scores in omaveloxolone (-1.55 ± 0.69) and placebo (0.85 ± 0.64) patients showed a difference between treatment groups of -2.40 ± 0.96 (p = 0.014). Transient reversible increases in aminotransferase levels were observed with omaveloxolone without increases in total bilirubin or other signs of liver injury. Headache, nausea, and fatigue were also more common among patients receiving omaveloxolone.
INTERPRETATION
In the MOXIe trial, omaveloxolone significantly improved neurological function compared to placebo and was generally safe and well tolerated. It represents a potential therapeutic agent in FA. ANN NEUROL 2020.",2020,Transient reversible increases in aminotransferase levels were observed with omaveloxolone without increases in total bilirubin or other signs of liver injury.,"['patients with FRDA', '155 patients were screened and 103', ""Eligible patients, 16 to 40\u2009years of age with genetically confirmed FRDA and baseline modified Friedreich's Ataxia Rating Scale (mFARS) scores between 20 and 80"", '11 institutions in the United States, Europe, and Australia (NCT02255435, EudraCT2015-002762-23']","['omaveloxolone patients and 42 placebo', 'placebo', 'Omaveloxolone', 'omaveloxolone']","['mFARS scores', 'total bilirubin', 'Safety and Efficacy', 'safety and efficacy', 'Headache, nausea, and fatigue', 'safe and well tolerated', 'mitochondrial function, restores redox balance', 'aminotransferase levels', 'mFARS score', 'neurological function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016719', 'cui_str': ""Friedreich's ataxia""}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016719', 'cui_str': ""Friedreich's ataxia""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",155.0,0.684078,Transient reversible increases in aminotransferase levels were observed with omaveloxolone without increases in total bilirubin or other signs of liver injury.,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lynch', 'Affiliation': ""Division of Neurology, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Melanie P', 'Initials': 'MP', 'LastName': 'Chin', 'Affiliation': 'Reata Pharmaceuticals, Dallas, TX, USA.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Delatycki', 'Affiliation': ""Victorian Clinical Genetics Services, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Subramony', 'Affiliation': 'Department of Neurology, McKnight Brain Institute, University of Florida Health System, Gainesville, FL, USA.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Corti', 'Affiliation': 'Department of Pediatrics, University of Florida Health System, Gainesville, FL, USA.'}, {'ForeName': 'J Chad', 'Initials': 'JC', 'LastName': 'Hoyle', 'Affiliation': 'Department of Neurology, Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Boesch', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Nachbauer', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Mariotti', 'Affiliation': 'Istituto di Ricovero e Cura a Carattere Scientifico-Carlo Besta Neurological Institute, Milan, Italy.'}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Mathews', 'Affiliation': 'Department of Neurology, University of Iowa Carver College of Medicine, Iowa City, IA, USA.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Giunti', 'Affiliation': 'University College London Hospital, London, United Kingdom.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wilmot', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Zesiewicz', 'Affiliation': 'Department of Neurology, University of South Florida Ataxia Research Center, Tampa, FL, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Perlman', 'Affiliation': 'Department of Neurology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Angie', 'Initials': 'A', 'LastName': 'Goldsberry', 'Affiliation': 'Reata Pharmaceuticals, Dallas, TX, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': ""O'Grady"", 'Affiliation': 'Reata Pharmaceuticals, Dallas, TX, USA.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Meyer', 'Affiliation': 'Reata Pharmaceuticals, Dallas, TX, USA.'}]",Annals of neurology,['10.1002/ana.25934']
1209,33068631,"Recovery of reward function in problematic substance users using a combination of robotics, electrophysiology, and TMS.","BACKGROUND
Theoretical and empirical work suggest that addictive drugs potentiate dopaminergic reinforcement learning signals and disrupt the reward function of its neural targets, including the anterior midcingulate cortex (aMCC) and the basal ganglia. Here, we aim to use prefrontal 10-Hz TMS to enhance aMCC reward activity and reward learning by the basal ganglia in problematic substance users.
METHODS
22 problematic substance users were randomized into an Active and SHAM (coil flipped) TMS group. We recorded the reward positivity-an electrophysiological signal believed to index sensitivity of the aMCC to rewards-while participants engaged in 4 blocks (100 trials per block) of a reward-based choice task. A robotic arm positioned a TMS coil over a prefrontal cortex target, and 50 pulses were delivered at 10-Hz before every 10 trials of blocks 2-4 (1500 pulses, 400 trials). Participants then completed a decision-making task that is diagnostic of striatal dopamine dysfunction.
RESULTS
The present study revealed three main findings. First, both groups failed to elicit a reward positivity during the first two task blocks. Second, applying robot-assisted TMS enhanced the amplitude of the reward positivity in the Active group, but not the SHAM group, across the last two task blocks. Third, the Active group performed relatively better at reward-based learning than the SHAM group.
CONCLUSION
These results demonstrate that 10-Hz TMS is successful in modulating the reward function of the aMCC and basal ganglia in problematic substance users, which may have utility in the treatment of reward-related neural dysfunction commonly associated with substance use disorders.",2020,"Second, applying robot-assisted TMS enhanced the amplitude of the reward positivity in the Active group, but not the SHAM group, across the last two task blocks.","['22 problematic substance users', 'problematic substance users']","['10-Hz', 'TMS', 'robotics, electrophysiology, and TMS', 'Active and SHAM (coil flipped', 'robot-assisted TMS', 'prefrontal 10-Hz TMS']",['amplitude of the reward positivity'],"[{'cui': 'C0338666', 'cui_str': 'Misuses drugs'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0013865', 'cui_str': 'Electrophysiology'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}]",,0.128632,"Second, applying robot-assisted TMS enhanced the amplitude of the reward positivity in the Active group, but not the SHAM group, across the last two task blocks.","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Biernacki', 'Affiliation': 'Center for Molecular and Behavioral Neuroscience, Rutgers University-Newark, Newark, NJ 07102, United States of America.'}, {'ForeName': 'Mei-Heng', 'Initials': 'MH', 'LastName': 'Lin', 'Affiliation': 'Center for Molecular and Behavioral Neuroscience, Rutgers University-Newark, Newark, NJ 07102, United States of America.'}, {'ForeName': 'Travis E', 'Initials': 'TE', 'LastName': 'Baker', 'Affiliation': 'Center for Molecular and Behavioral Neuroscience, Rutgers University-Newark, Newark, NJ 07102, United States of America. Electronic address: travis.e.baker@rutgers.edu.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.08.008']
1210,33068667,"Mindfulness, mood, and food: The mediating role of positive affect.","With rates of overweight and obesity rising worldwide, it is important to examine psychological factors associated with food intake. Previous research has shown that mindfulness may serve as a protective factor against overconsumption of food. Some studies have posited that mindfulness addresses unhealthy eating by promoting the increased awareness of, and decreased responsiveness to, internal emotional cues. The present study investigated the effects of a brief mindfulness induction on positive and negative affect and subsequent energy intake in a sample of undergraduate students (N = 126). After exposure to a negative mood induction, 63 participants were randomly assigned to a brief mindfulness intervention, while the remaining participants listened to a news article. Subsequently all participants were offered healthful and unhealthful snack foods. Although there was not a significant between-group difference in intake, a multiple mediation model indicated that positive affect, but not negative affect, significantly mediated the association between condition and food intake. Relative to controls, those in the experimental condition reported higher positive affect after the mindfulness induction, which in turn reduced their energy intake. Further exploratory analyses indicated that positive affect in the experimental group was associated with reduced consumption of unhealthful food. These findings provide insight into how mindfulness-based interventions may target unhealthy eating behaviors.",2020,"Although there was not a significant between-group difference in intake, a multiple mediation model indicated that positive affect, but not negative affect, significantly mediated the association between condition and food intake.","['63 participants', 'a sample of undergraduate students (N = 126']","['brief mindfulness intervention, while the remaining participants listened to a news article']","['positive and negative affect and subsequent energy intake', 'Mindfulness, Mood, and Food']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0282425', 'cui_str': 'News'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",63.0,0.0206694,"Although there was not a significant between-group difference in intake, a multiple mediation model indicated that positive affect, but not negative affect, significantly mediated the association between condition and food intake.","[{'ForeName': 'Ti', 'Initials': 'T', 'LastName': 'Hsu', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa, Iowa City, U.S.A. Electronic address: ti-hsu@uiowa.edu.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Forestell', 'Affiliation': 'Department of Psychological Sciences, William & Mary, P.O. Box 8795, Williamsburg, VA, 23187-8795, USA. Electronic address: caforestell@wm.edu.'}]",Appetite,['10.1016/j.appet.2020.105001']
1211,32598468,Electronically Monitored Nicotine Gum Use Before and After Smoking Lapses: Relationship With Lapse and Relapse.,"INTRODUCTION
Greater use of nicotine replacement therapy (NRT) is related to smoking cessation success, but the causal direction is unclear. This study characterized the relationship between NRT use and smoking lapse and relapse.
METHODS
Participants (N = 416 smokers; 57% female, 85% White) were recruited from primary care for a smoking cessation factorial experiment and analyzed if abstaining ≥1 day in the first 2 weeks post-target quit day (TQD). Participants were randomized to counseling and 8 versus 26 weeks of nicotine patch plus nicotine gum post-TQD. Participants carried electronic dispensers that timestamped each gum use. Participants who lapsed (smoked after abstaining) within 6 weeks post-TQD were matched with nonlapsers (n = 146 pairs) on multiple variables. We compared lapsers' versus matched nonlapsers' gum use in the 5 days before and after the lapsers' first lapse.
RESULTS
By week 6 post-TQD, 63% of participants lapsed. Compared with nonlapsers, lapsers used less gum 1 and 2 days pre-""lapse"" and on the 5 days post-lapse. Lapsers used less gum during the 5 days post-lapse than the 5 days pre-lapse. Univariate survival analyses with lapsers showed greater gum use during both pre- and post-lapse periods predicted longer latency to relapse in the first 6 weeks.
CONCLUSIONS
In a smoking cessation attempt using nicotine patch plus gum, lapsers versus matched nonlapsers used less gum immediately preceding and following their first lapse. Lower mean gum use before and after lapses predicted a more rapid escalation to relapse. Decreased nicotine gum use both precedes and follows returns to smoking during cessation attempts.
IMPLICATIONS
This research examined electronically monitored nicotine gum use collected in real time and found that among smokers engaged in a quit attempt, lapsers (vs. matched nonlapsers) tended to decrease their gum use 1-2 days prior to lapsing and to further decrease their gum use from pre- to post-lapse. Decreased gum use pre-lapse may signal heightened lapse risk in 1-2 days, with lower level of gum use predicting a more precipitous course of relapse. These results encourage further exploration of objective measures of smoking medication use patterns to examine their signaling properties and to inform understanding of cessation failure.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov NCT01120704.",2020,"In a smoking cessation attempt using nicotine patch plus gum, lapsers versus matched non-lapsers used less gum immediately preceding and following their first lapse.","['Participants who lapsed (smoked after abstaining) within 6 weeks post-TQD were matched with non-lapsers (n=146 pairs) on multiple variables', 'Participants (N=416 smokers; 57% female, 85% White) were recruited from primary care for a smoking cessation factorial experiment and analyzed if abstaining ≥1 day in the first 2 weeks post-target quit day (TQD']","['nicotine replacement therapy (NRT', 'nicotine patch plus nicotine gum post-TQD', 'nicotine patch plus gum, lapsers versus matched non-lapsers']",['Univariate survival analyses'],"[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}]",416.0,0.00852757,"In a smoking cessation attempt using nicotine patch plus gum, lapsers versus matched non-lapsers used less gum immediately preceding and following their first lapse.","[{'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Schlam', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Stevens S', 'Initials': 'SS', 'LastName': 'Smith', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Bolt', 'Affiliation': 'Department of Educational Psychology, University of Wisconsin-Madison, Madison, WI.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'McCarthy', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Cook', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Hayes-Birchler', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Fiore', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa116']
1212,32672570,Outcomes of the Shunt Tube Exposure Prevention Study: A Randomized Clinical Trial.,"PURPOSE
To compare the long-term safety and efficacy of amniotic membrane-umbilical cord (AM-UC) and pericardium patch grafts in reducing glaucoma shunt tube exposure.
DESIGN
Multicenter, prospective, randomized clinical trial.
PARTICIPANTS
Adults with uncontrolled glaucoma undergoing glaucoma drainage device (GDD) implantation.
METHODS
Patients were randomized to receive GDD with either AM-UC or pericardium patch grafts to cover GDD tubes. Patients were followed up clinically with anterior segment (AS) OCT to assess patch graft stability and host-tissue integration prospectively.
MAIN OUTCOME MEASURES
Tube exposure, graft thinning, and graft-related complications.
RESULTS
A total of 81 eyes of 81 patients (50 women, 31 men) with a mean age of 67±13 years underwent GGD implantation using Baerveldt (n = 72) or Ahmed valve (n = 9). Tubes were inserted in the anterior chamber (n = 71), sulcus (n = 6), or pars plana (n = 4). Tube ligation was performed with Baerveldt GDD along with fenestration (n = 51) or orphan trabeculectomy (n = 21). Tubes were covered with AM-UC (n = 41) or pericardium (n = 40). The mean follow-up time was 29±8 months (range, 13-40 months). Tube exposure occurred in 1 eye (2%) in the AM-UC group at 3 months and in 2 eyes (5%) in the pericardium group at 2 and 6 months (P = 0.54). Sequential AS OCT showed better host-tissue integration and significantly less graft thinning in the AM-UC group. Early graft thinning (≤3 months) occurred in 5 eyes (12%) in the AM-UC group and in 17 eyes (43%) in the pericardium group (P = 0.002). Late thinning occurred in 2 eyes (5%) and 11 eyes (28%) in the AM-UC and pericardium groups, respectively (P = 0.007). Graft translucency and cosmetic appearance of the AM-UC graft were superior to those of the pericardium graft. No evidence of graft rejection or infection was associated with the patch grafts in either group.
CONCLUSIONS
Amniotic membrane-umbilical cord grafts are well tolerated and offer an alternative to pericardium for safe and stable tube shunt coverage. Its high-tensile strength, low immunogenicity, and excellent host-tissue integration significantly reduced graft thinning.",2019,Graft translucency and cosmetic appearance of the AM-UC graft were superior to those of the pericardium graft.,"['Adults with uncontrolled glaucoma undergoing glaucoma drainage device (GDD) implantation', 'Patients', 'A total of 81 eyes of 81 patients (50 women, 31 men) with a mean age of 67±13 years underwent GGD implantation using Baerveldt (n\xa0= 72) or Ahmed valve (n']","['amniotic membrane-umbilical cord (AM-UC) and pericardium patch grafts', 'AM-UC', 'Tube ligation was performed with Baerveldt GDD along with fenestration (n\xa0= 51) or orphan trabeculectomy', 'GDD with either AM-UC or pericardium patch grafts to cover GDD tubes']","['graft rejection or infection', 'Tube exposure, graft thinning, and graft-related complications', 'graft thinning', 'Tube exposure', 'Early graft thinning', 'host-tissue integration', 'Late thinning', 'Graft translucency and cosmetic appearance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0181041', 'cui_str': 'Glaucoma drainage device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}]","[{'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0031050', 'cui_str': 'Pericardial sac structure'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0181041', 'cui_str': 'Glaucoma drainage device'}, {'cui': 'C0015825', 'cui_str': 'Inner ear fenestration'}, {'cui': 'C0242299', 'cui_str': 'Orphan'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0439844', 'cui_str': 'Covered'}]","[{'cui': 'C0018129', 'cui_str': 'Graft rejection'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",81.0,0.0452362,Graft translucency and cosmetic appearance of the AM-UC graft were superior to those of the pericardium graft.,"[{'ForeName': 'Hosam', 'Initials': 'H', 'LastName': 'Sheha', 'Affiliation': 'Department of Ophthalmology, Manhattan Eye, Ear & Throat Hospital, New York, New York; Hofstra Northwell Zucker School of Medicine, Hempstead, New York; Herbert Wertheim College of Medicine, Florida International University, Miami, Florida. Electronic address: hsheha@northwell.edu.'}, {'ForeName': 'Celso', 'Initials': 'C', 'LastName': 'Tello', 'Affiliation': 'Department of Ophthalmology, Manhattan Eye, Ear & Throat Hospital, New York, New York; Hofstra Northwell Zucker School of Medicine, Hempstead, New York.'}, {'ForeName': 'Lama A', 'Initials': 'LA', 'LastName': 'Al-Aswad', 'Affiliation': 'Harkness Eye Institute, Columbia University, New York, New York.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Sayed', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Lee', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: rlee@med.miami.edu.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2019.08.003']
1213,32678434,The effect of iron dosing schedules on plasma hepcidin and iron absorption in Kenyan infants.,"BACKGROUND
In adults, oral iron doses increase plasma hepcidin (PHep) for 24 h, but not for 48 h, and there is a circadian increase in PHep over the day. Because high PHep decreases fractional iron absorption (FIA), alternate day iron dosing in the morning may be preferable to consecutive day dosing. Whether these effects occur in infants is uncertain.
OBJECTIVE
Using stable iron isotopes in Kenyan infants, we compared FIA from morning and afternoon doses and from consecutive, alternate (every second day) and every third day iron doses.
METHODS
In prospective studies, we measured and compared FIA and the PHep response from 1) meals fortified with a 12-mg iron micronutrient powder given in the morning or afternoon (n = 22); 2) the same given on consecutive or alternate days (n = 21); and 3) a 12-mg iron supplement given on alternate days or every third day (n = 24).
RESULTS
In total, 65.7% of infants were anemic. In study 1, PHep did not differ between morning and afternoon (P = 0.072), and geometric mean FIA[-SD, +SD](%) did not differ between the morning and afternoon doses [15.9 (8.9, 28.6) and 16.1 (8.7, 29.8), P = 0.877]. In study 2, PHep was increased 24 h after oral iron (P = 0.014), and mean FIA [±SD](%) from the baseline dose [23.3 (10.9)] was greater than that from the consecutive day dose (at 24 h) [20.1 (10.4); P = 0.042] but did not differ from the alternate day dose (at 48 h) [20.9 (13.4); P = 0.145]. In study 3, PHep was not increased 48 and 72 h after oral iron (P = 0.384), and the geometric mean FIA[-SD, +SD](%) from doses given at baseline, alternate days, and every third day did not differ [12.7 (7.3, 21.9), 13.8 (7.8, 24.2), and 14.8 (8.8, 24.8), respectively; P = 0.080].
CONCLUSIONS
In Kenyan infants given 12 mg oral iron, morning and afternoon doses are comparably absorbed, dosing on consecutive days increases PHep and modestly decreases iron absorption compared with alternate day dosing, and dosing on alternate days or every third day does not increase PHep or decrease absorption. This trial was registered at clinicaltrials.gov as NCT02989311 and NCT03617575.",2020,"In study 3, PHep was not increased 48 and 72 h after oral iron (P = 0.384), and the geometric mean FIA[-SD, +SD](%) from doses given at baseline, alternate days, and every third day did not differ [12.7 (7.3, 21.9), 13.8 (7.8, 24.2), and 14.8 (8.8, 24.8), respectively; P = 0.080].
",['Kenyan infants'],[],"['geometric mean FIA[-SD, +SD', 'iron absorption', 'mean FIA [±SD', 'PHep or decrease absorption', 'plasma hepcidin and iron absorption', 'fractional iron absorption (FIA']","[{'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}]",,0.224107,"In study 3, PHep was not increased 48 and 72 h after oral iron (P = 0.384), and the geometric mean FIA[-SD, +SD](%) from doses given at baseline, alternate days, and every third day did not differ [12.7 (7.3, 21.9), 13.8 (7.8, 24.2), and 14.8 (8.8, 24.8), respectively; P = 0.080].
","[{'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Uyoga', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Mikulic', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Paganini', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Mwasi', 'Affiliation': 'Pediatric Department, Msambweni County Referral Hospital, Msambweni, Kenya.'}, {'ForeName': 'Nicole U', 'Initials': 'NU', 'LastName': 'Stoffel', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Zeder', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Karanja', 'Affiliation': 'Public and Community Health Department, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Zimmermann', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa174']
1214,32673222,The Effects of Telemonitoring on Patient Compliance With Self-Management Recommendations and Outcomes of the Innovative Telemonitoring Enhanced Care Program for Chronic Heart Failure: Randomized Controlled Trial.,"BACKGROUND
Telemonitoring enables care providers to remotely support outpatients in self-managing chronic heart failure (CHF), but the objective assessment of patient compliance with self-management recommendations has seldom been studied.
OBJECTIVE
This study aimed to evaluate patient compliance with self-management recommendations of an innovative telemonitoring enhanced care program for CHF (ITEC-CHF).
METHODS
We conducted a multicenter randomized controlled trial with a 6-month follow-up. The ITEC-CHF program comprised the provision of Bluetooth-enabled scales linked to a call center and nurse care services to assist participants with weight monitoring compliance. Compliance was defined a priori as weighing at least 4 days per week, analyzed objectively from weight recordings on the scales. The intention-to-treat principle was used to perform the analysis.
RESULTS
A total of 184 participants (141/184, 76.6% male), with a mean age of 70.1 (SD 12.3) years, were randomized to receive either ITEC-CHF (n=91) or usual care (control; n=93), of which 67 ITEC-CHF and 81 control participants completed the intervention. For the compliance criterion of weighing at least 4 days per week, the proportion of compliant participants in the ITEC-CHF group was not significantly higher than that in the control group (ITEC-CHF: 67/91, 74% vs control: 56/91, 60%; P=.06). However, the proportion of ITEC-CHF participants achieving the stricter compliance standard of at least 6 days a week was significantly higher than that in the control group (ITEC-CHF: 41/91, 45% vs control: 23/93, 25%; P=.005).
CONCLUSIONS
ITEC-CHF improved participant compliance with weight monitoring, although the withdrawal rate was high. Telemonitoring is a promising method for supporting both patients and clinicians in the management of CHF. However, further refinements are required to optimize this model of care.
TRIAL REGISTRATION
Australian New Zealand Clinical Trial Registry ACTRN12614000916640; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366691.",2020,"A total of 184 participants (141/184, 76.6% male), with a mean age of 70.1 (SD 12.3) years, were randomized to receive either ITEC-CHF (n=91) or usual care (control; n=93), of which 67 ITEC-CHF and 81 control participants completed the intervention.","['Chronic Heart Failure', 'A total of 184 participants (141/184, 76.6% male), with a mean age of 70.1 (SD 12.3) years']","['Innovative Telemonitoring Enhanced Care Program', 'ITEC-CHF', 'Telemonitoring']",['withdrawal rate'],"[{'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]",184.0,0.0472483,"A total of 184 participants (141/184, 76.6% male), with a mean age of 70.1 (SD 12.3) years, were randomized to receive either ITEC-CHF (n=91) or usual care (control; n=93), of which 67 ITEC-CHF and 81 control participants completed the intervention.","[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'RECOVER Injury Research Centre, Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Jayasena', 'Affiliation': 'The Australian e-Health Research Centre, Commonwealth Scientific & Industrial Research Organisation Health & Biosecurity, Melbourne, Australia.'}, {'ForeName': 'Sheau Huey', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Australia Faculty of Health Sciences, Curtin University, Perth, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Dowling', 'Affiliation': 'Department of Community Health, Peninsula Health, Melbourne, Australia.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Layland', 'Affiliation': 'Department of Cardiology, Peninsula Health, Melbourne, Australia.'}, {'ForeName': 'Norm', 'Initials': 'N', 'LastName': 'Good', 'Affiliation': 'RECOVER Injury Research Centre, Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Mohanraj', 'Initials': 'M', 'LastName': 'Karunanithi', 'Affiliation': 'RECOVER Injury Research Centre, Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Edwards', 'Affiliation': 'Department of Community Health, Peninsula Health, Melbourne, Australia.'}]",Journal of medical Internet research,['10.2196/17559']
1215,32673226,Effectiveness of a Transdiagnostic Guided Internet-Delivered Protocol for Emotional Disorders Versus Treatment as Usual in Specialized Care: Randomized Controlled Trial.,"BACKGROUND
Anxiety disorders and depression (emotional disorders) are highly prevalent mental disorders. Extensive empirical evidence supports the efficacy of cognitive behavioral therapy (CBT) for the treatment of these disorders. However, there are still some barriers related to their dissemination and implementation, which make it difficult for patients to receive these treatments, especially in public health care settings where resources are limited. Recent advances in improving CBT dissemination encompass different perspectives. One is the transdiagnostic approach, which offers treatment protocols that can be used for a range of emotional disorders. Another approach is the use of the internet to reach a larger number of people who could benefit from CBT.
OBJECTIVE
This study aimed to analyze the effectiveness and acceptability of a transdiagnostic internet-delivered protocol (EmotionRegulation) with human and automated guidance in patients from public specialized mental health care settings.
METHODS
A 2-armed randomized controlled trial (RCT) was conducted to compare the effectiveness of EmotionRegulation with treatment as usual (TAU) in specialized mental health care. In all, 214 participants were randomly assigned to receive either EmotionRegulation (n=106) or TAU (n=108). Measurement assessments were conducted at pre- and postintervention and at a 3-month follow-up.
RESULTS
The results revealed the superiority of EmotionRegulation over TAU on measures of depression (d=0.41), anxiety (d=0.35), and health-related quality of life (d=-0.45) at posttreatment, and these gains were maintained at the 3-month follow-up. Furthermore, the results for expectations and opinions showed that EmotionRegulation was well accepted by participants.
CONCLUSIONS
EmotionRegulation was more effective than TAU for the treatment of emotional disorders in the Spanish public mental health system. The implications of this RCT, limitations, and suggestions for future research are discussed.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02345668; https://clinicaltrials.gov/ct2/show/NCT02345668.",2020,"The results revealed the superiority of EmotionRegulation over TAU on measures of depression (d=0.41), anxiety (d=0.35), and health-related quality of life (d=-0.45) at posttreatment, and these gains were maintained at the 3-month follow-up.","['214 participants', 'specialized mental health care', 'Emotional Disorders Versus Treatment as Usual in Specialized Care', 'patients from public specialized mental health care settings']","['Transdiagnostic Guided Internet-Delivered Protocol', 'transdiagnostic internet-delivered protocol (EmotionRegulation) with human and automated guidance', 'EmotionRegulation', 'TAU', 'EmotionRegulation with treatment as usual (TAU', 'cognitive behavioral therapy (CBT']","['superiority of EmotionRegulation over TAU on measures of depression (d=0.41), anxiety (d=0.35), and health-related quality of life', 'effectiveness and acceptability']","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",214.0,0.109225,"The results revealed the superiority of EmotionRegulation over TAU on measures of depression (d=0.41), anxiety (d=0.35), and health-related quality of life (d=-0.45) at posttreatment, and these gains were maintained at the 3-month follow-up.","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'González-Robles', 'Affiliation': 'Department of Basic and Clinical Psychology, and Psychobiology, Universitat Jaume I, Castellón de la Plana, Spain.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Díaz-García', 'Affiliation': 'Department of Basic and Clinical Psychology, and Psychobiology, Universitat Jaume I, Castellón de la Plana, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Department of Basic and Clinical Psychology, and Psychobiology, Universitat Jaume I, Castellón de la Plana, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Roca', 'Affiliation': 'Department of Personality, Assessment, and Clinical Psychology, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Josep Antoni', 'Initials': 'JA', 'LastName': 'Ramos-Quiroga', 'Affiliation': ""Department of Psychiatry, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'Department of Basic and Clinical Psychology, and Psychobiology, Universitat Jaume I, Castellón de la Plana, Spain.'}]",Journal of medical Internet research,['10.2196/18220']
1216,32673228,Evaluating the Impact of the Grading and Assessment of Predictive Tools Framework on Clinicians and Health Care Professionals' Decisions in Selecting Clinical Predictive Tools: Randomized Controlled Trial.,"BACKGROUND
While selecting predictive tools for implementation in clinical practice or for recommendation in clinical guidelines, clinicians and health care professionals are challenged with an overwhelming number of tools. Many of these tools have never been implemented or evaluated for comparative effectiveness. To overcome this challenge, the authors developed and validated an evidence-based framework for grading and assessment of predictive tools (the GRASP framework). This framework was based on the critical appraisal of the published evidence on such tools.
OBJECTIVE
The aim of the study was to examine the impact of using the GRASP framework on clinicians' and health care professionals' decisions in selecting clinical predictive tools.
METHODS
A controlled experiment was conducted through a web-based survey. Participants were randomized to either review the derivation publications, such as studies describing the development of the predictive tools, on common traumatic brain injury predictive tools (control group) or to review an evidence-based summary, where each tool had been graded and assessed using the GRASP framework (intervention group). Participants in both groups were asked to select the best tool based on the greatest validation or implementation. A wide group of international clinicians and health care professionals were invited to participate in the survey. Task completion time, rate of correct decisions, rate of objective versus subjective decisions, and level of decisional conflict were measured.
RESULTS
We received a total of 194 valid responses. In comparison with not using GRASP, using the framework significantly increased correct decisions by 64%, from 53.7% to 88.1% (88.1/53.7=1.64; t 193 =8.53; P<.001); increased objective decision making by 32%, from 62% (3.11/5) to 82% (4.10/5; t 189 =9.24; P<.001); decreased subjective decision making based on guessing by 20%, from 49% (2.48/5) to 39% (1.98/5; t 188 =-5.47; P<.001); and decreased prior knowledge or experience by 8%, from 71% (3.55/5) to 65% (3.27/5; t 187 =-2.99; P=.003). Using GRASP significantly decreased decisional conflict and increased the confidence and satisfaction of participants with their decisions by 11%, from 71% (3.55/5) to 79% (3.96/5; t 188 =4.27; P<.001), and by 13%, from 70% (3.54/5) to 79% (3.99/5; t 188 =4.89; P<.001), respectively. Using GRASP decreased the task completion time, on the 90th percentile, by 52%, from 12.4 to 6.4 min (t 193 =-0.87; P=.38). The average System Usability Scale of the GRASP framework was very good: 72.5% and 88% (108/122) of the participants found the GRASP useful.
CONCLUSIONS
Using GRASP has positively supported and significantly improved evidence-based decision making. It has increased the accuracy and efficiency of selecting predictive tools. GRASP is not meant to be prescriptive; it represents a high-level approach and an effective, evidence-based, and comprehensive yet simple and feasible method to evaluate, compare, and select clinical predictive tools.",2020,"In comparison with not using GRASP, using the framework significantly increased correct decisions by 64%, from 53.7% to 88.1% (88.1/53.7=1.64; t 193 =8.53; P<.001); increased objective decision making by 32%, from 62% (3.11/5) to 82% (4.10/5; t 189 =9.24; P<.001); decreased subjective decision making based on guessing by 20%, from 49% (2.48/5) to 39% (1.98/5; t 188 =-5.47; P<.001); and decreased prior knowledge or experience by 8%, from 71% (3.55/5) to 65% (3.27/5; t 187 =-2.99; P=.003).",[],['GRASP framework'],"['Task completion time, rate of correct decisions, rate of objective versus subjective decisions, and level of decisional conflict', 'correct decisions', 'task completion time', 'prior knowledge or experience', 'objective decision making', 'average System Usability Scale of the GRASP framework', 'decisional conflict', 'confidence and satisfaction']",[],"[{'cui': 'C0220843', 'cui_str': 'Grasp'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",194.0,0.087758,"In comparison with not using GRASP, using the framework significantly increased correct decisions by 64%, from 53.7% to 88.1% (88.1/53.7=1.64; t 193 =8.53; P<.001); increased objective decision making by 32%, from 62% (3.11/5) to 82% (4.10/5; t 189 =9.24; P<.001); decreased subjective decision making based on guessing by 20%, from 49% (2.48/5) to 39% (1.98/5; t 188 =-5.47; P<.001); and decreased prior knowledge or experience by 8%, from 71% (3.55/5) to 65% (3.27/5; t 187 =-2.99; P=.003).","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Khalifa', 'Affiliation': 'Centre for Health Informatics, Australian Institute of Health Innovation, Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Magrabi', 'Affiliation': 'Centre for Health Informatics, Australian Institute of Health Innovation, Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Gallego Luxan', 'Affiliation': 'Centre for Big Data Research in Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}]",Journal of medical Internet research,['10.2196/15770']
1217,32679403,"Commentary on Liu, K. et al. (2018). 'Handgrip exercise reduces peripherally-inserted central catheter-related venous thrombosis in patients with solid cancers: A randomized controlled trial'.",,2020,,['patients with solid cancers'],['Handgrip exercise reduces peripherally-inserted central catheter-related venous thrombosis'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}]",[],,0.162369,,"[{'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Ying', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China. Electronic address: yanpingying0116@126.com.'}, {'ForeName': 'Jianpeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103691']
1218,32679405,A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311.,"PURPOSE
Understanding the role of transoral surgery in oropharyngeal cancer (OPC) requires prospective, randomized multi-institutional data. Meticulous evaluation of surgeon expertise and surgical quality assurance (QA) will be critical to the validity of such trials. We describe a novel surgeon credentialing and QA process developed to support the ECOG-ACRIN Cancer Research Group E3311 (E3311) and report outcomes related to QA.
PATIENTS AND METHODS
E3311 was a phase II randomized clinical trial of transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC. In order to be credentialed to accrue to this trial, surgeons were required to demonstrate active hospital credentials and technique-specific surgical expertise with ≥20 cases of transoral resection for OPC. In addition, 10 paired operative and surgical pathology reports from the preceding 24 months were reviewed by an expert panel. Ongoing QA required <10% rate of positive margins, low oropharyngeal bleeding rates, and accrual of at least one patient per 12 months. Otherwise surgeons were placed on hold and not permitted to accrue until re-credentialed using a new series of transoral resections.
RESULTS
120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers. During QA on E3311, positive final pathologic margins were reported in 19 (3.8%) patients. Grade III/IV and grade V oropharyngeal bleeding was reported in 29 (5.9%) and 1 (0.2%) of patients.
CONCLUSIONS
We provide proof of concept that a comprehensive credentialing process can support multicenter transoral head and neck surgical oncology trials, with low incidence of positive margins and *grade III/V oropharyngeal bleeding.",2020,"RESULTS
120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","['120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers', 'oropharyngeal cancer (OPC']","['surgeon expertise and surgical quality assurance (QA', 'transoral surgery', 'transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC']","['positive final pathologic margins', 'positive margins, low oropharyngeal bleeding rates', 'Grade III/IV and grade V oropharyngeal bleeding']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0010298', 'cui_str': 'Credentialing'}, {'cui': 'C0030768', 'cui_str': 'Peer review'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",120.0,0.0606723,"RESULTS
120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States. Electronic address: Ferrisrl@upmc.edu.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Flamand', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'F Christopher', 'Initials': 'FC', 'LastName': 'Holsinger', 'Affiliation': 'Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Weinstein', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Joaquin J', 'Initials': 'JJ', 'LastName': 'Garcia', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Hinni', 'Affiliation': 'Mayo Clinic in Arizona, Phoenix, AZ, United States.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Gross', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Erich M', 'Initials': 'EM', 'LastName': 'Sturgis', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Umamaheswar', 'Initials': 'U', 'LastName': 'Duvvuri', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Méndez', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ridge', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Magnuson', 'Affiliation': 'Florida Hospital Orlando, Celebration, FL, United States.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Higgins', 'Affiliation': 'ECOG-ACRIN Cancer Research Group, Boston, MA, United States.'}, {'ForeName': 'Mihir R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Russel B', 'Initials': 'RB', 'LastName': 'Smith', 'Affiliation': 'University of Nebraska, Omaha, NE, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Karakla', 'Affiliation': 'Sentara Norfolk General Hospital, Norfolk, VA, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Kupferman', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Malone', 'Affiliation': 'UPMC Pinnacle Cancer Center, Harrisburg, PA, United States.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Judson', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Richmon', 'Affiliation': 'Massachusetts Eye and Ear, Harvard University, Boston, MA, United States.'}, {'ForeName': 'Jay O', 'Initials': 'JO', 'LastName': 'Boyle', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Bayon', 'Affiliation': 'University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Bert W', 'Initials': 'BW', 'LastName': ""O'Malley"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Enver', 'Initials': 'E', 'LastName': 'Ozer', 'Affiliation': 'The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Giovana R', 'Initials': 'GR', 'LastName': 'Thomas', 'Affiliation': 'University of Miami Leonard Miller School of Medicine, Miami, FL, United States.'}, {'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Koch', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'R Bryan', 'Initials': 'RB', 'LastName': 'Bell', 'Affiliation': 'Providence Cancer Institute, Portland, OR, United States.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'Elin R', 'Initials': 'ER', 'LastName': 'Sigurdson', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104797']
1219,32680781,Evaluating trajectories of statin adherence after a motivational interviewing intervention.,"OBJECTIVE
The objective of the current study was to compare postintervention adherence trajectories with preintervention trajectories for those receiving a telephonic motivational interviewing (MoI) intervention to determine predictors associated with each distinct postintervention trajectory and any association between pre- and postintervention trajectories.
DESIGN
Retrospective study design using group-based trajectory modeling.
SETTINGS AND PARTICIPANTS
A telephonic MoI intervention was conducted by trained student pharmacists to improve statin adherence in a Medicare Advantage plan. Four preintervention adherence trajectories were previously identified: rapid decline (RD), gradual decline (GD), gaps in adherence (GA), and adherent and were used to customize the MoI intervention. Patients from the 3 nonadherent preintervention trajectories were randomized to control or intervention groups and were followed for 6 months from the date of MoI intervention.
OUTCOME MEASURES
Group-based trajectory modeling was performed to identify 3 relevant postintervention trajectories. Descriptive statistics were used to assess differences in pre- and postintervention adherence trajectories. Multinomial logistic regression was conducted to determine predictors associated with each identified postintervention trajectory.
RESULTS
There were 152 intervention patients and 304 randomly selected controls. The prominent postintervention trajectories that were identified differed from the preintervention trajectories and were (1) GD (17.2%), (2) adherent (61.9%), and (3) discontinuation (20.9%). Among the intervention group, more patients in the GA preintervention trajectory (58.65%) moved to the adherent trajectory postintervention than those in the RD and GD preintervention trajectories. Furthermore, the predictors associated with the postintervention trajectories included MoI intervention, prescriber specialty, presence of diabetes, presence of congestive heart failure, Centers for Medicare & Medicaid Services risk score, and preintervention trajectories.
CONCLUSION
The postintervention adherence trajectory patterns differed from the preintervention trajectory patterns with many patients moving into an adherent trajectory especially among those receiving the intervention.",2020,"Among the intervention group, more patients in the GA preintervention trajectory (58.65%) moved to the adherent trajectory postintervention than those in the RD and GD preintervention trajectories.","['152 intervention patients and 304 randomly selected controls', 'Patients from the 3 nonadherent preintervention trajectories']",['telephonic motivational interviewing (MoI) intervention'],"['MoI intervention, prescriber specialty, presence of diabetes, presence of congestive heart failure, Centers for Medicare & Medicaid Services risk score, and preintervention trajectories', 'rapid decline (RD), gradual decline (GD), gaps in adherence (GA), and adherent', 'statin adherence']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]",,0.0167063,"Among the intervention group, more patients in the GA preintervention trajectory (58.65%) moved to the adherent trajectory postintervention than those in the RD and GD preintervention trajectories.","[{'ForeName': 'Rutugandha', 'Initials': 'R', 'LastName': 'Paranjpe', 'Affiliation': ''}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Vadhariya', 'Affiliation': ''}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'E James', 'Initials': 'EJ', 'LastName': 'Essien', 'Affiliation': ''}, {'ForeName': 'Tara W', 'Initials': 'TW', 'LastName': 'Esse', 'Affiliation': ''}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Gallardo', 'Affiliation': ''}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Serna', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Abughosh', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2020.06.011']
1220,32680782,Patient outcomes from implementing an enhanced services pharmacy network.,"OBJECTIVE
To evaluate the effect of implementing a network of community pharmacies on medication adherence, health service utilization, and health care spending.
DESIGN
Quasi-experimental difference-in-difference analysis with a nonequivalent control group.
SETTING AND PARTICIPANTS
Eligible Medicaid-enrolled patients in North Carolina were attributed to intervention pharmacies between March 2015 and December 2016. A control group was propensity score-matched. Interventions consisted of enhanced services and a more intensive, comprehensive initial pharmacy assessment (CIPA).
OUTCOME MEASURES
Outcomes included hospitalizations; emergency department (ED) visits; health care spending for total medical, inpatient, outpatient, and ED services; and adherence to renin-angiotensin system antagonists (RASA), statins, noninsulin diabetes medications (NIDM), and multiple medications for chronic conditions (MMCC).
RESULTS
There were 31,509 patients who met eligibility criteria and were attributed to a participating pharmacy. Of these, 3897 received a CIPA. Before matching, patients attributed to participating pharmacies had greater Medicaid enrollment through aged, blind, or disabled status (49.2% vs. 31.5%, P < 0.001); greater case management (10.3% vs. 7%, P < 0.001); and worse rates of chronic disease (P < 0.001). Successful matching removed these differences. Adherence to RASA medications and MMCC increased by 9.5% and 10.3% (P < 0.05), respectively. Adherence did not change for statins and NIDM. The analysis also revealed a slower decline in average total medical spending of 5.7% (P < 0.01) relative to the control group over the same period, owed to a 9.6% (P < 0.001) slower decline in outpatient spending. ED utilization also decreased more slowly relative to controls by 4.8% (P < 0.05) following the intervention.
CONCLUSION
The pharmacy intervention resulted in a statistically significant improvement in medication adherence to RASA and multiple chronic medications, but did not change or may have worsened utilization and spending outcomes. More research is needed to explore patient selection and variation in implementation and heterogeneity of treatment effects when evaluating pharmacy interventions.",2020,"The pharmacy intervention resulted in a statistically significant improvement in medication adherence to RASA and multiple chronic medications, but did not change or may have worsened utilization and spending outcomes.","['Eligible Medicaid-enrolled patients in North Carolina were attributed to intervention pharmacies between March 2015 and December 2016', '31,509 patients who met eligibility criteria and were attributed to a participating pharmacy']","['CIPA', 'enhanced services and a more intensive, comprehensive initial pharmacy assessment (CIPA']","['medication adherence to RASA and multiple chronic medications', 'ED utilization', 'rates of chronic disease', 'average total medical spending', 'hospitalizations; emergency department (ED) visits; health care spending for total medical, inpatient, outpatient, and ED services; and adherence to renin-angiotensin system antagonists (RASA), statins, noninsulin diabetes medications (NIDM), and multiple medications for chronic conditions (MMCC', 'Adherence to RASA medications and MMCC', 'Adherence']","[{'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",31509.0,0.0527363,"The pharmacy intervention resulted in a statistically significant improvement in medication adherence to RASA and multiple chronic medications, but did not change or may have worsened utilization and spending outcomes.","[{'ForeName': 'Benjamin Y', 'Initials': 'BY', 'LastName': 'Urick', 'Affiliation': ''}, {'ForeName': 'Troy K', 'Initials': 'TK', 'LastName': 'Trygstad', 'Affiliation': ''}, {'ForeName': 'Joel F', 'Initials': 'JF', 'LastName': 'Farley', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2020.05.009']
1221,32687185,A multi-institutional randomized phase III trial comparing anatomical segmentectomy and wedge resection for clinical stage IA non-small cell lung cancer in high-risk operable patients: Japan Clinical Oncology Group Study JCOG1909 (ANSWER study).,"Anatomical segmentectomy or wedge resection is recommended for high-risk operable patients with clinical stage IA non-small cell lung cancer in guidelines of the National Comprehensive Cancer Network and the Japanese Lung Cancer Society. However, there is no clear evidence comparing the sublobar resections. The less invasive and more generally performed is wedge resection but anatomical segmentectomy may have better survival benefits than wedge resection owing to its superiority in locoregional control. In April 2020, we have initiated a randomized phase III trial in Japan to confirm the superiority of anatomical segmentectomy over wedge resection in high-risk operable patients with clinical stage IA non-small cell lung cancer. We plan to enroll a total of 370 patients from 47 institutions over a period of 5 years. The primary endpoint is overall survival; the secondary endpoints are adverse events, postoperative respiratory function, relapse-free survival, proportion of local recurrence, operative time and blood loss.",2020,"In April 2020, we have initiated a randomized phase III trial in Japan to confirm the superiority of anatomical segmentectomy over wedge resection in high-risk operable patients with clinical stage IA non-small cell lung cancer.","['high-risk operable patients', 'high-risk operable patients with clinical stage IA non-small cell lung cancer', 'high-risk operable patients with clinical stage IA non-small cell lung cancer in guidelines of the National Comprehensive Cancer Network and the Japanese Lung Cancer Society', '370 patients from 47 institutions over a period of 5\xa0years']","['anatomical segmentectomy over wedge resection', 'anatomical segmentectomy and wedge resection', 'Anatomical segmentectomy or wedge resection']","['overall survival', 'survival benefits', 'adverse events, postoperative respiratory function, relapse-free survival, proportion of local recurrence, operative time and blood loss']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0024885', 'cui_str': 'Partial mastectomy'}, {'cui': 'C0184909', 'cui_str': 'Wedge resection - action'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",370.0,0.203473,"In April 2020, we have initiated a randomized phase III trial in Japan to confirm the superiority of anatomical segmentectomy over wedge resection in high-risk operable patients with clinical stage IA non-small cell lung cancer.","[{'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Shimoyama', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Tsutani', 'Affiliation': 'Department of Surgical Oncology, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Wakabayashi', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shun-Ichi', 'Initials': 'SI', 'LastName': 'Watanabe', 'Affiliation': 'Division of Thoracic Surgery, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa107']
1222,32682696,Electronic Decision Support for Management of CKD in Primary Care: A Pragmatic Randomized Trial.,"RATIONALE & OBJECTIVE
Most adults with chronic kidney disease (CKD) in the United States are cared for by primary care providers (PCPs). We evaluated the feasibility and preliminary effectiveness of an electronic clinical decision support system (eCDSS) within the electronic health record with or without pharmacist follow-up to improve the management of CKD in primary care.
STUDY DESIGN
Pragmatic cluster-randomized trial.
SETTING & PARTICIPANTS
524 adults with confirmed creatinine-based estimated glomerular filtration rates of 30 to 59mL/min/1.73m 2 cared for by 80 PCPs at the University of California San Francisco. Electronic health record data were used for patient identification, intervention deployment, and outcomes ascertainment.
INTERVENTIONS
Each PCP's eligible patients were randomly assigned as a group into 1 of 3 treatment arms: (1) usual care; (2) eCDSS: testing of creatinine, cystatin C, and urinary albumin-creatinine ratio with individually tailored guidance for PCPs on blood pressure, potassium, and proteinuria management, cardiovascular risk reduction, and patient education; or (3) eCDSS plus pharmacist counseling (eCDSS-PLUS).
OUTCOMES
The primary clinical outcome was change in blood pressure over 12 months. Secondary outcomes were PCP awareness of CKD and use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and statin therapy.
RESULTS
All 80 eligible PCPs participated. Mean patient age was 70 years, 47% were nonwhite, and mean estimated glomerular filtration rate was 56±0.6mL/min/1.73m 2 . Among patients receiving eCDSS with or without pharmacist counseling (n=336), 178 (53%) completed laboratory measurements and 138 (41%) had laboratory measurements followed by a PCP visit with eCDSS deployment. eCDSS was opened by the PCP for 102 (74%) patients, with at least 1 suggested order signed for 83 of these 102 (81%). Changes in systolic blood pressure were-2.1±1.5mm Hg with usual care, -2.8±1.8mm Hg with eCDSS, and -1.1±1.1 with eCDSS-PLUS (P=0.7). PCP awareness of CKD was 16% with usual care, 26% with eCDSS, and 32% for eCDSS-PLUS (P=0.09). In as-treated analyses, PCP awareness of CKD was significantly greater with eCDSS and eCDSS-PLUS (73% and 69%) versus usual care (47%; P=0.002).
LIMITATIONS
Recruitment of smaller than intended sample size and limited uptake of the testing component of the intervention.
CONCLUSIONS
Although we were unable to demonstrate the effectiveness of eCDSS to lower blood pressure and uptake of the eCDSS was limited by low testing rates, eCDSS use was high when laboratory measurements were available and was associated with higher PCP awareness of CKD.
FUNDING
Grants from government (National Institutes of Health) and not-for-profit (American Heart Association) entities.
TRIAL REGISTRATION
Registered at ClinicalTrials.gov with study number NCT02925962.",2020,"PCP awareness of CKD was 16% with usual care, 26% with eCDSS, and 32% for eCDSS -PLUS (p=0.09).","[' 524 adults with confirmed eGFRCr 30-59 mL/min/1.73m 2 cared for by 80 PCPs at the University of California San Francisco', 'Mean patient age was 70, 47% were non-white, mean eGFRcr was 56 +/-0.6', 'Primary Care', 'All 80 eligible PCPs participated', 'patients receiving eCDSS with or without pharmacist counseling (n=336), 178 (53%) completed labs and 138 (41%) had labs followed by a PCP visit with eCDSS deployment', 'adults with chronic kidney disease (CKD) in the U.S. are cared for by primary care providers (PCP']","['eCDSS', 'electronic clinical decision support system (eCDSS', 'usual care, 2) eCDSS: testing of creatinine, cystatin C and urinary albumin-to-creatinine ratio with individually tailored guidance for PCPs on blood pressure, potassium and proteinuria management, cardiovascular risk-reduction, and patient education, or 3) eCDSS plus pharmacist counseling (eCDSS-PLUS']","['blood pressure', 'blood pressure, and uptake of the eCDSS', 'PCP awareness of CKD', 'systolic blood pressure', 'PCP awareness of CKD as well as use of ACEi/ARB and statin']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]",524.0,0.0628094,"PCP awareness of CKD was 16% with usual care, 26% with eCDSS, and 32% for eCDSS -PLUS (p=0.09).","[{'ForeName': 'Carmen A', 'Initials': 'CA', 'LastName': 'Peralta', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA; The Kidney Health Research Collaborative, University of California San Francisco, San Francisco, CA; Cricket Health, Inc, San Francisco, CA. Electronic address: carmenalicia.peralta@ucsf.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Livaudais-Toman', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA; Multiethnic Health Equity Research Center, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Stebbins', 'Affiliation': 'Department of Clinical PharmacyUniversity of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Lowell', 'Initials': 'L', 'LastName': 'Lo', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA; Multiethnic Health Equity Research Center, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Scherzer', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA; The Kidney Health Research Collaborative, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Leah S', 'Initials': 'LS', 'LastName': 'Karliner', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA; Multiethnic Health Equity Research Center, University of California San Francisco, San Francisco, CA.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2020.05.013']
1223,32682735,Effect of an Informative Video on Anxiety and Hemodynamic Parameters in Patients Requiring Mandibular Third Molar Extraction: A Randomized Clinical Trial.,"PURPOSE
The purpose was to determine the effect of watching an informative video about mandibular third molar (M3M) removal on patient anxiety and hemodynamic parameters.
PATIENTS AND METHODS
A randomized controlled clinical trial was carried out in healthy patients (aged between 18 and 40 years) requiring M3M extraction under local anesthesia. Patients with previous tooth extractions, psychiatric disorders, or cardiac problems or patients undergoing anxiolytic or antidepressant drug treatment were excluded. Participants were randomized into 2 groups according to whether they watched an informative video about the surgical procedure (video group) or not (control group). The primary outcome variable was the difference between groups regarding patient anxiety assessed with the State-Trait Anxiety Inventory (STAI) and the Modified Dental Anxiety Scale (MDAS). The secondary outcome variables were hemodynamic parameters recorded during different moments of the surgical procedure. Descriptive, bivariate, and multivariate analyses were performed, and a repeated-measures mixed model was generated. Statistical significance was considered for P < .05.
RESULTS
Fifty patients referred for M3M extraction met the inclusion criteria. The final data analysis was based on 47 patients: 25 from the video group and 22 controls. The bivariate analysis showed the video group to have a significant decrease in anxiety as measured by the MDAS (P = .006; 95% confidence interval [CI], -4.1 to -0.7) and STAI-State (P = .003; 95% CI, -13.7 to -0.7). A significantly lower heart rate was likewise found in the video group (χ 2 = 4.30, df = 1, P = .038). The linear regression analysis adjusting for the STAI-Trait also showed lower dental anxiety measured by the MDAS in the video group (P = .023; 95% CI, 0.32 to 4.14).
CONCLUSIONS
Providing preoperative information through an informative video about M3M removal significantly reduces patient anxiety and heart rate during the surgical procedure.",2020,"A significantly lower heart rate was likewise found in the video group (χ 2 = 4.30, df = 1, P = .038).","['47 patients: 25 from the video group and 22 controls', 'Patients Requiring Mandibular Third Molar Extraction', 'Fifty patients referred for M3M extraction met the inclusion criteria', 'healthy patients (aged between 18 and 40\xa0years) requiring M3M extraction under local anesthesia', 'Patients with previous tooth extractions, psychiatric disorders, or cardiac problems or patients undergoing anxiolytic or antidepressant drug treatment were excluded']","['informative video about the surgical procedure (video group) or not (control group', 'watching an informative video about mandibular third molar (M3M) removal', 'Informative Video']","['patient anxiety and heart rate', 'anxiety', 'hemodynamic parameters recorded during different moments of the surgical procedure', 'Anxiety and Hemodynamic Parameters', 'dental anxiety', 'heart rate', 'patient anxiety assessed with the State-Trait Anxiety Inventory (STAI) and the Modified Dental Anxiety Scale (MDAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",50.0,0.095681,"A significantly lower heart rate was likewise found in the video group (χ 2 = 4.30, df = 1, P = .038).","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Toledano-Serrabona', 'Affiliation': 'Fellow of the Master Degree of Oral Surgery and Implantology, School of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Sánchez-Torres', 'Affiliation': 'Associate Professor of Oral Surgery, Master Degree Program in Oral Surgery and Implantology, School of Medicine and Health Sciences, University of Barcelona; and Researcher at IDIBELL (Bellvitge Biomedical Research Institute), Barcelona, Spain.'}, {'ForeName': 'Octavi', 'Initials': 'O', 'LastName': 'Camps-Font', 'Affiliation': 'Associate Professor of Oral Surgery, Master Degree Program in Oral Surgery and Implantology, School of Medicine and Health Sciences, University of Barcelona; and Researcher at IDIBELL (Bellvitge Biomedical Research Institute), Barcelona, Spain.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Figueiredo', 'Affiliation': 'Lecturer in Oral Surgery and Coordinator of the Master Degree Program in Oral Surgery and Implantology, School of Medicine and Health Sciences, University of Barcelona; and Researcher at IDIBELL (Bellvitge Biomedical Research Institute), Barcelona, Spain. Electronic address: ruipfigueiredo@hotmail.com.'}, {'ForeName': 'Cosme', 'Initials': 'C', 'LastName': 'Gay-Escoda', 'Affiliation': 'Chairman and Professor of Oral and Maxillofacial Surgery, School of Medicine and Health Sciences, University of Barcelona; Director of the Master Degree Program in Oral Surgery and Implantology, EFHRE International University/FUCSO (Fundacio Catalana per a la Salut Oral); Coordinator/Researcher at IDIBELL (Bellvitge Biomedical Research Institute); and Head of the Oral Surgery, Implantology and Maxillofacial Surgery Department, Teknon Medical Center, Barcelona, Spain.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Valmaseda-Castellón', 'Affiliation': 'Senior Lecturer in Oral Surgery and Director of the Master Degree Program in Oral Surgery and Implantology, School of Medicine and Health Sciences, University of Barcelona; and Researcher at IDIBELL (Bellvitge Biomedical Research Institute), Barcelona, Spain.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.06.024']
1224,33065990,Socio-Demographic Characteristics and Body Weight Perceptions of Study Participants Benefitting Most from the Feel4Diabetes Program Based on Their Anthropometric and Glycaemic Profile Changes.,"The Feel4Diabetes program was comprised of a community-based screening and a two-year intervention phase aiming to prevent type 2 diabetes (T2D) in families at risk for diabetes across Europe. The current work aimed to identify the socio-demographic characteristics and body weight perceptions of participants who benefitted the most, achieving at least a 5% reduction in body weight, waist circumference and glycaemic indices (fasting plasma glucose, insulin, glycosylated haemoglobin levels), over two-year period. Following a two-stage screening procedure, 2294 high-risk parents were randomly allocated to standard care or more intensive intervention. The participants who benefitted most were living in Southern (OR 2.39-3.67, p < 0.001) and Eastern Europe (OR 1.55-2.47, p < 0.05), received more intensive intervention (OR 1.53-1.90, p = 0.002) and were younger (<40 years old) adults (OR 1.48-1.51, p < 0.05). Furthermore, individuals with tertiary education (OR 2.06, p < 0.001), who were unemployed (OR 1.62-1.68, p < 0.05) and perceived their body weight to be higher than normal (OR 1.58-3.00, p < 0.05) were more likely to benefit from the program. Lastly, males were more likely to show improvements in their glycaemic profiles compared to females (OR 1.40, p = 0.024). These findings point out the regions in Europe and the sociodemographic profile of individuals that benefitted the most in the current study, highlighting the need to prioritise regions in greater need for such interventions and also tailor future interventions to the characteristics and perceptions of the target populations.",2020,"The participants who benefitted most were living in Southern (OR 2.39-3.67, p < 0.001) and Eastern Europe (OR 1.55-2.47, p < 0.05), received more intensive intervention (OR 1.53-1.90, p = 0.002) and were younger (<40 years old) adults (OR 1.48-1.51, p < 0.05).",['2294 high-risk parents'],"['standard care or more intensive intervention', 'Feel4Diabetes Program']","['glycaemic profiles', 'body weight, waist circumference and glycaemic indices (fasting plasma glucose, insulin, glycosylated haemoglobin levels', 'body weight', 'Socio-Demographic Characteristics and Body Weight Perceptions']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",2294.0,0.0350729,"The participants who benefitted most were living in Southern (OR 2.39-3.67, p < 0.001) and Eastern Europe (OR 1.55-2.47, p < 0.05), received more intensive intervention (OR 1.53-1.90, p = 0.002) and were younger (<40 years old) adults (OR 1.48-1.51, p < 0.05).","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Moschonis', 'Affiliation': 'Department of Dietetics, Nutrition and Sport, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, VIC 3086, Australia.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Karatzi', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': 'Kyriaki', 'Initials': 'K', 'LastName': 'Apergi', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Liatis', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, 11527 Athens, Greece.'}, {'ForeName': 'Jemina', 'Initials': 'J', 'LastName': 'Kivelä', 'Affiliation': 'Department of Public Health Solutions, Finnish Institute for Health and Welfare, 00271 Helsinki, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wikström', 'Affiliation': 'Department of Public Health Solutions, Finnish Institute for Health and Welfare, 00271 Helsinki, Finland.'}, {'ForeName': 'Alelí M', 'Initials': 'AM', 'LastName': 'Ayala-Marín', 'Affiliation': 'Growth, Exercise, Nutrition and Development (GENUD) Research Group, Instituto Agroalimentario de Aragón (IA2), Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Mateo-Gallego', 'Affiliation': 'Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Kaloyan', 'Initials': 'K', 'LastName': 'Tsochev', 'Affiliation': 'Department of Paediatrics, Medical University Varna, 9002 Varna, Bulgaria.'}, {'ForeName': 'Nevena', 'Initials': 'N', 'LastName': 'Chakarova', 'Affiliation': 'Clinical Center of Endocrinology, Department of Diabetology, Medical University Sofia, 1431 Sofia, Bulgaria.'}, {'ForeName': 'Emese', 'Initials': 'E', 'LastName': 'Antal', 'Affiliation': 'Hungarian Society of Nutrition, 1088 Budapest, Hungary.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Rurik', 'Affiliation': 'Hungarian Society of Nutrition, 1088 Budapest, Hungary.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Iotova', 'Affiliation': 'Department of Paediatrics, Medical University Varna, 9002 Varna, Bulgaria.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Cardon', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, 9000 Gent, Belgium.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Lindstrom', 'Affiliation': 'Department of Public Health Solutions, Finnish Institute for Health and Welfare, 00271 Helsinki, Finland.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Moreno', 'Affiliation': 'Growth, Exercise, Nutrition and Development (GENUD) Research Group, Instituto Agroalimentario de Aragón (IA2), Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Makrilakis', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, 11527 Athens, Greece.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 17671 Athens, Greece.'}]",Nutrients,['10.3390/nu12103117']
1225,33066009,Choline Intake as Supplement or as a Component of Eggs Increases Plasma Choline and Reduces Interleukin-6 without Modifying Plasma Cholesterol in Participants with Metabolic Syndrome.,"Metabolic syndrome (MetS) is characterized by low-grade inflammation and insulin resistance, which increase the risk of heart disease. Eggs have numerous nutrients including choline, carotenoids, and fat-soluble vitamins that may protect against these conditions. Egg phosphatidylcholine (PC) is a major contributor of dietary choline in the American diet. However, uncertainty remains regarding eggs due to their high concentration of cholesterol. In this study, we evaluated the effect of two sources of choline, whole eggs (a source of PC) and a choline supplement (choline bitartrate, CB), on plasma lipids, glucose, insulin resistance, and inflammatory biomarkers. We recruited 23 subjects with MetS to participate in this randomized cross-over intervention. After a 2-week washout, with no choline intake, participants were randomly allocated to consume three eggs/day or CB (~400 mg choline/d for both) for 4 weeks. After a 3-week washout period, they were allocated to the alternate treatment. Dietary records indicated higher concentrations of vitamin E and selenium during the egg period ( p < 0.01). Interestingly, there were no changes in plasma total, low density lipoprotein (LDL)- or high density lipoprotein (HDL)-cholesterol, triglycerides, or glucose, compared either to baseline or between treatments. In contrast, interleukin-6 was reduced, with both sources of choline compared to baseline, while eggs also had an effect on lowering C-reactive protein, insulin, and insulin resistance compared to baseline. This study demonstrates that in a MetS population, intake of three eggs per day does not increase plasma LDL cholesterol, and has additional benefits on biomarkers of disease compared to a choline supplement, possibly due to the presence of other antioxidants in eggs.",2020,Dietary records indicated higher concentrations of vitamin E and selenium during the egg period ( p < 0.01).,"['Participants with Metabolic Syndrome', '23 subjects with MetS to participate in this randomized cross-over intervention']","['Egg phosphatidylcholine (PC', 'CB', 'choline, whole eggs (a source of PC) and a choline supplement (choline bitartrate, CB']","['concentrations of vitamin E and selenium', 'Metabolic syndrome (MetS', 'lowering C-reactive protein, insulin, and insulin resistance', 'plasma total, low density lipoprotein (LDL)- or high density lipoprotein (HDL)-cholesterol, triglycerides, or glucose', 'plasma lipids, glucose, insulin resistance, and inflammatory biomarkers', 'plasma LDL cholesterol']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C1959616', 'cui_str': 'Lecithin'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0008408', 'cui_str': 'Choline bitartrate'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1278149', 'cui_str': 'Plasma LDL cholesterol measurement'}]",23.0,0.0838643,Dietary records indicated higher concentrations of vitamin E and selenium during the egg period ( p < 0.01).,"[{'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'DiBella', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Minu S', 'Initials': 'MS', 'LastName': 'Thomas', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Alyousef', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Millar', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Blesso', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Malysheva', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Caudill', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Maria Luz', 'Initials': 'ML', 'LastName': 'Fernandez', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, CT 06269, USA.'}]",Nutrients,['10.3390/nu12103120']
1226,33066040,Effect of a Nutritional Support System (Diet and Supplements) for Improving Gross Motor Function in Cerebral Palsy: An Exploratory Randomized Controlled Clinical Trial.,"BACKGROUND
Most patients with cerebral palsy (CP) do not respond to physical therapy due to deterioration in their nutritional status, secondary to gastrointestinal disorders and the catabolic state of the disease itself. However, basic treatments only contemplate the energy requirements and do not consider supplementation with glutamine, zinc, selenium, colecalciferol, spirulina, omega 3 or even vegetal proteins.
OBJECTIVE
In this study, we determined the effect of using a nutritional support system (NSS): diet and supplements, on the gross motor function in children with CP with spastic diparesic and Gross Motor Function Classification System III (GMFCS III).
METHODS
An exploratory study was performed. Thirty patients (from 4 to 12 years old) were randomly assigned to: (1) dietary surveillance (FG), (2) deworming and WHO diet (CG), or (3) deworming and the NSS (IG). Gross motor function was evaluated using the gross motor function measure (GMFM) scale.
RESULTS
The IG-treated group presented a significant improvement in standing and walking parameters analyzed in the GMFM compared with FG and CG groups. Fifty percent of the IG-treated patients managed to walk, while in the other groups, no patients were able to walk.
CONCLUSIONS
The NSS used in the present work improves gross motor function and promotes walking in patients with CP.",2020,The IG-treated group presented a significant improvement in standing and walking parameters analyzed in the GMFM compared with FG and CG groups.,"['patients with cerebral palsy (CP', 'Thirty patients (from 4 to 12 years old', 'Cerebral Palsy', 'children with CP with spastic diparesic and Gross Motor Function Classification System III (GMFCS III', 'patients with CP']","['Nutritional Support System (Diet and Supplements', 'dietary surveillance (FG), (2) deworming and WHO diet (CG), or (3) deworming and the NSS (IG', 'nutritional support system (NSS): diet and supplements']","['standing and walking parameters', 'gross motor function measure (GMFM) scale', 'Gross motor function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0199859', 'cui_str': 'Deworming'}]","[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",30.0,0.017051,The IG-treated group presented a significant improvement in standing and walking parameters analyzed in the GMFM compared with FG and CG groups.,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Leal-Martínez', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Franco', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Peña-Ruiz', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Castro-Silva', 'Affiliation': 'Departamento de Terapia Física, Centro de Rehabilitación e Inclusión Infantil Teletón (CRIT), Tlalnepantla de Baz 54010, Mexico.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Escudero-Espinosa', 'Affiliation': 'Departamento de Terapia Física, Centro de Rehabilitación e Inclusión Infantil Teletón (CRIT), Tlalnepantla de Baz 54010, Mexico.'}, {'ForeName': 'Oscar G', 'Initials': 'OG', 'LastName': 'Rolón-Lacarrier', 'Affiliation': 'Departamento de Investigación y Enseñanza, Centro de Rehabilitación e Inclusión Infantil Teletón (CRIT), Tlalnepantla de Baz 54010, Mexico.'}, {'ForeName': 'Mardia', 'Initials': 'M', 'LastName': 'López-Alarcón', 'Affiliation': 'Unidad de Investigación Médica en Nutrición, Hospital de Pediatría CMN siglo XXI, Ciudad de Mexico 06720, Mexico.'}, {'ForeName': 'Ximena', 'Initials': 'X', 'LastName': 'De León', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Linares-Eslava', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ibarra', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud (CICSA), FCS, Universidad Anáhuac México Norte, Huixquilucan 52786, Mexico.'}]","Foods (Basel, Switzerland)",['10.3390/foods9101449']
1227,31228190,Genetic variation at the coronary artery disease risk locus GUCY1A3 modifies cardiovascular disease prevention effects of aspirin.,"AIMS
Efficacy of aspirin in primary prevention of cardiovascular disease (CVD) may be influenced by a common allele in guanylate cyclase GUCY1A3, which has been shown to modify platelet function and increase CVD risk.
METHODS AND RESULTS
We investigated whether homozygotes of the GUCY1A3 rs7692387 risk (G) allele benefited from aspirin in two long-term, randomized placebo-controlled trials of aspirin in primary CVD prevention: the Women's Genome Health Study (WGHS, N = 23 294) and a myocardial infarction (MI, N = 550) and stroke (N = 382) case-control set from the Physician's Health Study (PHS, N = 22 071). Bleeding risk was evaluated in the WGHS. In the placebo group of the WGHS, the GUCY1A3 risk (G) allele was confirmed to increase CVD risk [hazard ratio 1.38; 95% confidence interval (CI) 1.08-1.78; P = 0.01]. Random-effects meta-analysis of the WGHS and PHS revealed that aspirin reduced CVD events among risk allele homozygotes [G/G: odds ratio (OR) 0.79; 95% CI 0.65-0.97; P = 0.03] but increased CVD events among non-risk allele carriers (e.g. G/A: OR 1.39; 95% CI 1.03-1.87; P = 0.03) thus implying an interaction between genotype stratum and aspirin intake (Pinteraction = 0.01). Bleeding associated with aspirin increased in all genotype groups, with higher risks in heterozygotes.
CONCLUSION
In two randomized placebo-controlled trials in the setting of primary prevention, aspirin reduced the incidence of CVD events in individuals homozygous for the GUCY1A3 risk (G) allele, whereas heterozygote individuals had more events when taking aspirin.",2019,"Bleeding associated with aspirin increased in all genotype groups, with higher risks in heterozygotes.
","['individuals homozygous for the GUCY1A3 risk (G) allele, whereas heterozygote individuals', ""primary CVD prevention: the Women's Genome Health Study (WGHS, N\u2009"", ""23\xa0294) and a myocardial infarction (MI, N\u2009=\u2009550) and stroke (N\u2009=\u2009382) case-control set from the Physician's Health Study (PHS, N\u2009=\u200922\xa0071""]","['placebo', 'aspirin']","['incidence of CVD events', 'CVD risk', 'CVD events', 'Bleeding risk']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C1519418', 'cui_str': 'GUCY1A3 protein, human'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0019425', 'cui_str': 'Heterozygote'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C0007328', 'cui_str': 'Case Control Studies'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.283633,"Bleeding associated with aspirin increased in all genotype groups, with higher risks in heterozygotes.
","[{'ForeName': 'Kathryn T', 'Initials': 'KT', 'LastName': 'Hall', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Kessler', 'Affiliation': 'Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V., Partner Site Munich Heart Alliance, Lazarettstrasse 36, 80636 Munich, Germany.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Dani', 'Initials': 'D', 'LastName': 'Passow', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Howard D', 'Initials': 'HD', 'LastName': 'Sesso', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Robert Y L', 'Initials': 'RYL', 'LastName': 'Zee', 'Affiliation': 'Department of Pediatric Dentistry, Tufts University School of Dental Medicine, Boston, MA, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Chasman', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02146, USA.""}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V., Partner Site Munich Heart Alliance, Lazarettstrasse 36, 80636 Munich, Germany.'}]",European heart journal,['10.1093/eurheartj/ehz384']
1228,33084335,Increased Intestinal Permeability in Older Subjects Impacts the Beneficial Effects of Dietary Polyphenols by Modulating Their Bioavailability.,"Polyphenols have great potential in regulating intestinal health and ameliorating pathological conditions related to increased intestinal permeability (IP). However, the efficacy of dietary interventions with these phytochemicals may significantly be influenced by interindividual variability factors affecting their bioavailability and consequent biological activity. In the present study, urine samples collected from older subjects undergoing a crossover intervention trial with polyphenol-rich foods were subjected to metabolomics analysis for investigating the impact of increased IP on the bioavailability of polyphenols. Interestingly, urinary levels of phase II and microbiota-derived metabolites were significantly different between subjects with healthier intestinal barrier integrity and those with increased IP disruption. Our results support that this IP-dependent impaired bioavailability of polyphenols could be attributed to disturbances in the gut microbial metabolism and phase II methylation processes. Furthermore, we also observed that microbiota-derived metabolites could be largely responsible for the biological activity elicited by dietary polyphenols against age-related disrupted IP.",2020,"Interestingly, urinary levels of phase II and microbiota-derived metabolites were significantly different between subjects with healthier intestinal barrier integrity and those with increased IP disruption.","['Older Subjects', 'older subjects undergoing a crossover intervention trial with']","['Polyphenols', 'Dietary Polyphenols', 'polyphenol-rich foods']","['Intestinal Permeability', 'urinary levels of phase II and microbiota-derived metabolites']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0453861', 'cui_str': 'Rich food'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0234876,"Interestingly, urinary levels of phase II and microbiota-derived metabolites were significantly different between subjects with healthier intestinal barrier integrity and those with increased IP disruption.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hidalgo-Liberona', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, Food Technology Reference Net (XaRTA), Nutrition and Food Safety Research Institute (INSA), Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'González-Domínguez', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, Food Technology Reference Net (XaRTA), Nutrition and Food Safety Research Institute (INSA), Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Vegas', 'Affiliation': 'CIBER Fragilidad y Envejecimiento Saludable (CIBERfes), Instituto de Salud Carlos III, 28029 Barcelona, Spain.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Riso', 'Affiliation': 'Università degli Studi di Milano, Department of Food, Environmental and Nutritional Sciences (DeFENS), 20133 Milano, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': ""Del Bo'"", 'Affiliation': 'Università degli Studi di Milano, Department of Food, Environmental and Nutritional Sciences (DeFENS), 20133 Milano, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Bernardi', 'Affiliation': 'Università degli Studi di Milano, Department of Food, Environmental and Nutritional Sciences (DeFENS), 20133 Milano, Italy.'}, {'ForeName': 'Gregorio', 'Initials': 'G', 'LastName': 'Peron', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, Food Technology Reference Net (XaRTA), Nutrition and Food Safety Research Institute (INSA), Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Guglielmetti', 'Affiliation': 'Università degli Studi di Milano, Department of Food, Environmental and Nutritional Sciences (DeFENS), 20133 Milano, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Gargari', 'Affiliation': 'Università degli Studi di Milano, Department of Food, Environmental and Nutritional Sciences (DeFENS), 20133 Milano, Italy.'}, {'ForeName': 'Paul Antony', 'Initials': 'PA', 'LastName': 'Kroon', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, NR4 7UQ Norwich, United Kingdom.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cherubini', 'Affiliation': ""Geriatria, Accettazione Geriatrica e Centro di Ricerca per l'Invecchiamento, IRCCS INRCA, 60127 Ancona, Italy.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Andrés-Lacueva', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, Food Technology Reference Net (XaRTA), Nutrition and Food Safety Research Institute (INSA), Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}]",Journal of agricultural and food chemistry,['10.1021/acs.jafc.0c04976']
1229,33079959,Homologous and heterologous re-challenge with Salmonella Typhi and Salmonella Paratyphi A in a randomised controlled human infection model.,"Enteric fever is a systemic infection caused by Salmonella Typhi or Paratyphi A. In many endemic areas, these serovars co-circulate and can cause multiple infection-episodes in childhood. Prior exposure is thought to confer partial, but incomplete, protection against subsequent attacks of enteric fever. Empirical data to support this hypothesis are limited, and there are few studies describing the occurrence of heterologous-protection between these closely related serovars. We performed a challenge-re-challenge study using a controlled human infection model (CHIM) to investigate the extent of infection-derived immunity to Salmonella Typhi or Paratyphi A infection. We recruited healthy volunteers into two groups: naïve volunteers with no prior exposure to Salmonella Typhi/Paratyphi A and volunteers previously-exposed to Salmonella Typhi or Paratyphi A in earlier CHIM studies. Within each group, participants were randomised 1:1 to oral challenge with either Salmonella Typhi (104 CFU) or Paratyphi A (103 CFU). The primary objective was to compare the attack rate between naïve and previously challenged individuals, defined as the proportion of participants per group meeting the diagnostic criteria of temperature of ≥38°C persisting for ≥12 hours and/or S. Typhi/Paratyphi bacteraemia up to day 14 post challenge. The attack-rate in participants who underwent homologous re-challenge with Salmonella Typhi was reduced compared with challenged naïve controls, although this reduction was not statistically significant (12/27[44%] vs. 12/19[63%]; Relative risk 0.70; 95% CI 0.41-1.21; p = 0.24). Homologous re-challenge with Salmonella Paratyphi A also resulted in a lower attack-rate than was seen in challenged naïve controls (3/12[25%] vs. 10/18[56%]; RR0.45; 95% CI 0.16-1.30; p = 0.14). Evidence of protection was supported by a post hoc analysis in which previous exposure was associated with an approximately 36% and 57% reduced risk of typhoid or paratyphoid disease respectively on re-challenge. Individuals who did not develop enteric fever on primary exposure were significantly more likely to be protected on re-challenge, compared with individuals who developed disease on primary exposure. Heterologous re-challenge with Salmonella Typhi or Salmonella Paratyphi A was not associated with a reduced attack rate following challenge. Within the context of the model, prior exposure was not associated with reduced disease severity, altered microbiological profile or boosting of humoral immune responses. We conclude that prior Salmonella Typhi and Paratyphi A exposure may confer partial but incomplete protection against subsequent infection, but with a comparable clinical and microbiological phenotype. There is no demonstrable cross-protection between these serovars, consistent with the co-circulation of Salmonella Typhi and Paratyphi A. Collectively, these data are consistent with surveillance and modelling studies that indicate multiple infections can occur in high transmission settings, supporting the need for vaccines to reduce the burden of disease in childhood and achieve disease control. Trial registration NCT02192008; clinicaltrials.gov.",2020,"The attack-rate in participants who underwent homologous re-challenge with Salmonella Typhi was reduced compared with challenged naïve controls, although this reduction was not statistically significant (12/27[44%] vs. 12/19[63%]; Relative risk 0.70; 95% CI 0.41-1.21; p = 0.24).",['healthy volunteers into two groups: naïve volunteers with no prior exposure to Salmonella Typhi/Paratyphi A and volunteers previously-exposed to Salmonella Typhi or Paratyphi A in earlier CHIM studies'],"['Salmonella Typhi (104 CFU) or Paratyphi A (103 CFU', 'Salmonella Typhi or Salmonella Paratyphi', 'Salmonella Typhi and Salmonella Paratyphi']","['lower attack-rate', 'attack rate', 'attack-rate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C2732504', 'cui_str': 'Exposure to Salmonella'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0036125', 'cui_str': 'Salmonella Typhi'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036125', 'cui_str': 'Salmonella Typhi'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0036115', 'cui_str': 'Salmonella Paratyphi C'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",,0.0655881,"The attack-rate in participants who underwent homologous re-challenge with Salmonella Typhi was reduced compared with challenged naïve controls, although this reduction was not statistically significant (12/27[44%] vs. 12/19[63%]; Relative risk 0.70; 95% CI 0.41-1.21; p = 0.24).","[{'ForeName': 'Malick M', 'Initials': 'MM', 'LastName': 'Gibani', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Sonu', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Norman', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Blackwell', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Thomaides-Brears', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Christoph J', 'Initials': 'CJ', 'LastName': 'Blohmke', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Hazel C', 'Initials': 'HC', 'LastName': 'Dobinson', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Baker', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Yama F', 'Initials': 'YF', 'LastName': 'Mujadidi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Plested', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Preciado-Llanes', 'Affiliation': 'Institute for Infection and Global Health, University of Liverpool, United Kingdom.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Napolitani', 'Affiliation': 'Medical Research Council Human Immunology Unit, Radcliffe Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Simmons', 'Affiliation': 'Medical Research Council Human Immunology Unit, Radcliffe Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Melita A', 'Initials': 'MA', 'LastName': 'Gordon', 'Affiliation': 'Institute for Infection and Global Health, University of Liverpool, United Kingdom.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Angus', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Darton', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Cerundulo', 'Affiliation': 'Medical Research Council Human Immunology Unit, Radcliffe Department of Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, United Kingdom.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008783']
1230,33080291,Effects of nicotine on pupil size and performance during multiple-object tracking in non-nicotine users.,"Nicotine has been commonly used in pyschopharmacological studies, showing its benefits as a pharmacological stimulant on cognitive performance. In the current study, we investigated the effects of 2 mg (Experiment 1) and 4 mg (Experiment 2) of nicotine on performance on a multiple-object-tracking task. Participants were young non-smoking adults with no pre-existing attentional deficits. Nicotine and placebo were administered through nicotine and nicotine-free taste-matched chewing gum, respectively. Additionally, we compared pupil size between nicotine and placebo conditions in both experiments. Although we found that pupil size was considerably smaller in the nicotine conditions, nicotine administration did not appear to facilitate behavioural performance. We speculate that nicotine might enhance performance only for certain cognitive functions, and only for specific populations, such as nicotine-deprived smokers.",2020,"Although we found that pupil size was considerably smaller in the nicotine conditions, nicotine administration did not appear to facilitate behavioural performance.","['Participants were young non-smoking adults with no pre-existing attentional deficits', 'non-nicotine users']","['nicotine', 'Nicotine', 'nicotine and nicotine-free taste-matched chewing gum', 'Nicotine and placebo']","['behavioural performance', 'pupil size and performance during multiple-object tracking', 'pupil size']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4302494', 'cui_str': 'Nicotine user'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]",,0.0190549,"Although we found that pupil size was considerably smaller in the nicotine conditions, nicotine administration did not appear to facilitate behavioural performance.","[{'ForeName': 'I K', 'Initials': 'IK', 'LastName': 'Wardhani', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway; Department of Experimental Psychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS Groningen, the Netherlands; Department of Experimental Psychology, Ghent University, Henri Dunantlaan 2, 9000 Ghent, Belgium. Electronic address: intankusuma.wardhani@ugent.be.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mathôt', 'Affiliation': 'Department of Experimental Psychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS Groningen, the Netherlands.'}, {'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Boehler', 'Affiliation': 'Department of Experimental Psychology, Ghent University, Henri Dunantlaan 2, 9000 Ghent, Belgium.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Laeng', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.09.005']
1231,33080294,The effects of an internet-based mindfulness meditation intervention on electrophysiological markers of attention.,"Evidence suggests that mindfulness meditation training has the potential to train aspects of attention. However, the neurophysiological mechanisms underpinning the attentional benefits from mindfulness remain unclear. This randomized controlled trial examined changes in electrophysiological markers of attention before and after completion of a 6-week internet-based mindfulness intervention. EEG and ERP data were collected from 64 generally healthy, mildly stressed older adults. Participants were randomized to an internet-based mindfulness-based stress reduction course (IMMI), an internet-based health and wellness education course, or a waitlist control condition. Attentional N2 and P3 evoked potentials were derived from active and passive auditory oddball paradigms. Participants in the IMMI group showed significantly greater differences in P3 peak-trough amplitude between the active and passive oddball paradigms at endpoint relative to controls. There were no significant relationships between the intervention and N2 potentials. Our data demonstrate a measurable increase in attentional control when discriminating or directing attention away from auditory stimuli for older adult participants who received mindfulness training. These findings lend support to the use of the P3 as a neurophysiological measure of meditation engagement and intervention efficacy.",2020,Participants in the IMMI group showed significantly greater differences in P3 peak-trough amplitude between the active and passive oddball paradigms at endpoint relative to controls.,"['64 generally healthy, mildly stressed older adults']","['internet-based mindfulness meditation intervention', 'mindfulness meditation training', 'internet-based mindfulness-based stress reduction course (IMMI), an internet-based health and wellness education course, or a wait list control condition', '6-week internet-based mindfulness intervention']","['attentional control', 'P3 peak-trough amplitude', 'Attentional N2 and P3 evoked potentials']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]",64.0,0.0204774,Participants in the IMMI group showed significantly greater differences in P3 peak-trough amplitude between the active and passive oddball paradigms at endpoint relative to controls.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Klee', 'Affiliation': 'Oregon Health & Science University, Department of Neurology, United States of America. Electronic address: klee@ohsu.edu.'}, {'ForeName': 'Dana Dharmakaya', 'Initials': 'DD', 'LastName': 'Colgan', 'Affiliation': 'Oregon Health & Science University, Department of Neurology, United States of America.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hanes', 'Affiliation': 'National University of Natural Medicine, United States of America.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Oken', 'Affiliation': 'Oregon Health & Science University, Department of Neurology, United States of America; Oregon Health & Science University, Departments of Behavioral Neuroscience and Biomedical Engineering, United States of America.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.10.002']
1232,33080740,The effect of preoperative intravenous lidocaine on postoperative pain following hysteroscopy: A randomized controlled trial.,"BACKGROUND
The use of hysteroscopy for the diagnosis and treatment of uterine and endometrial abnormalities is often associated with postoperative pain. This randomized controlled trial aimed to assess the efficacy of preoperative intravenous (IV) lidocaine in reducing pain after hysteroscopy.
METHODS
In total, 138 patients undergoing elective hysteroscopy at the CHA Bundang Medical Center, Seongnam, Korea were randomly assigned to a control group (n = 69) or a lidocaine group (n = 69), which received normal saline or IV lidocaine at 1.5 mg/kg, respectively. The primary outcome was the incidence of postoperative pain.
RESULTS
The incidence of pain was significantly lower in the IV lidocaine group than in the control group at the post-anesthesia care unit (27.3% vs 68.2%, P < .001). The visual analog scale (0-10) score (median [interquartile range]) was lower in the IV lidocaine group than in the control group (0 [0-2]) vs 2 [0-4]), P < .001). The use of rescue analgesics and postoperative nausea and vomiting were similar between the 2 groups. This study demonstrated that administering 1.5 mg/kg of preoperative IV lidocaine can be a simple method to reduce incidence of pain after hysteroscopy.
CONCLUSION
Preoperative bolus administration of 1.5 mg/kg of IV lidocaine may be used to decrease incidence of pain after hysteroscopy under general anesthesia.",2020,"The incidence of pain was significantly lower in the IV lidocaine group than in the control group at the post-anesthesia care unit (27.3% vs 68.2%, P < .001).","['following hysteroscopy', '138 patients undergoing elective hysteroscopy at the CHA Bundang Medical Center, Seongnam, Korea']","['normal saline or IV lidocaine', 'preoperative intravenous (IV) lidocaine', 'lidocaine']","['visual analog scale', 'postoperative nausea and vomiting', 'incidence of pain', 'incidence of postoperative pain', 'postoperative pain', 'pain']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0574369', 'cui_str': 'Chamorro language'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",138.0,0.190699,"The incidence of pain was significantly lower in the IV lidocaine group than in the control group at the post-anesthesia care unit (27.3% vs 68.2%, P < .001).","[{'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University, Seongnam.'}, {'ForeName': 'Seunghoon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University, Seongnam.'}, {'ForeName': 'Heungwoo', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University, Seongnam.'}, {'ForeName': 'Hyeon Chul', 'Initials': 'HC', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, CHA Bundang Medical Center, CHA University, Seongnam.'}, {'ForeName': 'Chunghyun', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, CHA Bundang Medical Center, CHA University, Seongnam.'}, {'ForeName': 'Jong Yeop', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, Korea.'}]",Medicine,['10.1097/MD.0000000000022751']
1233,33080746,Neuromuscular electrical stimulation in early rehabilitation of patients with postoperative complications after cardiovascular surgery: A randomized controlled trial.,"BACKGROUND
To evaluate the effectiveness of neuromuscular electrical stimulation (NMES) in early rehabilitation of patients with postoperative complications after cardiovascular surgery.
METHODS
37 patients (25 men and 12 women) aged 45 to 70 years with postoperative complications after cardiovascular surgery were included in the study. Eighteen patients underwent NMES daily since postoperative day 3 until discharge in addition to standard rehabilitation program (NMES group), and 19 patients underwent standard rehabilitation program only (non-NMES group). The primary outcome was the knee extensors strength at discharge in NMES group and in control. Secondary outcomes were the handgrip strength, knee flexor strength, and cross-sectional area (CSA) of the quadriceps femoris in groups at discharge.
RESULTS
Baseline characteristics were not different between the groups. Knee extensors strength at discharge was significantly higher in the NMES group (28.1 [23.8; 36.2] kg on the right and 27.45 [22.3; 33.1] kg on the left) than in the non-NMES group (22.3 [20.1; 27.1] and 22.5 [20.1; 25.9] kg, respectively; P < .001). Handgrip strength, knee flexor strength, quadriceps CSA, and 6 minute walk distance at discharge in the groups had no significant difference.
CONCLUSIONS
This pilot study shows a beneficial effect of NMES on muscle strength in patients with complications after cardiovascular surgery. The use of NMES showed no effect on strength of non-stimulated muscle, quadriceps CSA, and distance of 6-minute walk test at discharge.Further blind randomized controlled trials should be performed with emphasis on the effectiveness of NEMS in increasing muscle strength and structure in these patients.",2020,Knee extensors strength at discharge was significantly higher in the NMES group (28.1 [23.8; 36.2] kg on the right and 27.45,"['37 patients (25 men and 12 women) aged 45 to 70 years with postoperative complications after cardiovascular surgery were included in the study', 'Eighteen patients underwent NMES daily since postoperative day 3 until discharge in addition to standard rehabilitation program (NMES group), and 19 patients underwent', 'patients with complications after cardiovascular surgery', 'patients with postoperative complications after cardiovascular surgery']","['NMES', 'Neuromuscular electrical stimulation', 'neuromuscular electrical stimulation (NMES', 'NEMS', 'standard rehabilitation program']","['handgrip strength, knee flexor strength, and cross-sectional area (CSA) of the quadriceps femoris in groups at discharge', 'muscle strength', 'Knee extensors strength at discharge', 'strength of non-stimulated muscle, quadriceps CSA, and distance of 6-minute walk test at discharge', 'Handgrip strength, knee flexor strength, quadriceps CSA, and 6 minute walk distance at discharge', 'knee extensors strength at discharge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0038897', 'cui_str': 'Cardiovascular surgical procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",18.0,0.182019,Knee extensors strength at discharge was significantly higher in the NMES group (28.1 [23.8; 36.2] kg on the right and 27.45,"[{'ForeName': 'Alexey Nikolaevich', 'Initials': 'AN', 'LastName': 'Sumin', 'Affiliation': ''}, {'ForeName': 'Pavel Alexandrovich', 'Initials': 'PA', 'LastName': 'Oleinik', 'Affiliation': ''}, {'ForeName': 'Andrey Viktorovich', 'Initials': 'AV', 'LastName': 'Bezdenezhnykh', 'Affiliation': ''}, {'ForeName': 'Anna Valeryvena', 'Initials': 'AV', 'LastName': 'Ivanova', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022769']
1234,33080765,Effects of Thrower's Ten exercises on upper extremity performance: A randomized controlled study.,"OBJECTIVES
The Thrower's Ten Exercise program is an exercise program especially designed to improve the strength, power and endurance of the shoulder complex. The aim of this study was to investigate the effects of the Thrower's Ten exercises on the upper extremity performance in healthy sedentary individuals.
METHODS
36 healthy sedentary individuals completed this study conducted with a randomized controlled design. The subjects were divided into 2 groups: exercise and control. The exercise group received a training of the Thrower's Ten exercises of 50-minute sessions 3 times a week for a duration of 8 weeks. Before and after the study, the subjects were tested for dynamic balance on the upper extremity with the Upper Limp Y balance test and for explosive power with the medicine ball throw test. Moreover, the strength of the shoulder internal and external rotator muscles was measured with an isokinetic dynamometer at a speed of 60°/second. The study was registered on the Clinical Trials website by the number NCT04162886.
RESULTS
A comparison between the groups showed significant differences in terms of dynamic balance and explosive power (P < .05), but not in terms of isokinetic muscle strength and body composition (P > .05). On the other hand, comparisons of the dynamic equilibrium, explosive power and isokinetic muscle strength parameters within the exercise group returned statistically different results (P < .05).
CONCLUSIONS
The Thrower's Ten exercises represent an effective method to improve the balance on the upper extremity, explosive power and isokinetic strength in healthy sedentary individuals.",2020,"A comparison between the groups showed significant differences in terms of dynamic balance and explosive power (P < .05), but not in terms of isokinetic muscle strength and body composition (P > .05).","['healthy sedentary individuals', '36 healthy sedentary individuals']",['exercise and control'],"['dynamic balance and explosive power', 'dynamic equilibrium, explosive power and isokinetic muscle strength parameters', 'upper extremity performance', 'strength of the shoulder internal and external rotator muscles', 'isokinetic muscle strength and body composition']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0015330', 'cui_str': 'Explosive device'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0224320', 'cui_str': 'Structure of rotator muscle'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",36.0,0.0170843,"A comparison between the groups showed significant differences in terms of dynamic balance and explosive power (P < .05), but not in terms of isokinetic muscle strength and body composition (P > .05).","[{'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Gokalp', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Eastern Mediterranean University, Famagusta, North Cyprus, 99628, via Mersin-10, Turkey.'}, {'ForeName': 'Berkiye', 'Initials': 'B', 'LastName': 'Kirmizigil', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022837']
1235,33080806,Rehabilitation Improves Mitochondrial Energetics in Progressive Multiple Sclerosis: The Significant Role of Robot-Assisted Gait Training and of the Personalized Intensity.,"Abnormal levels of pyruvate and lactate were reported in multiple sclerosis (MS). We studied the response of markers of mitochondrial function to rehabilitation in relation to type, intensity and endurance performance in severely disabled MS patients. Forty-six progressive MS patients were randomized to receive 12 walking sessions of robot-assisted gait training (RAGT, n = 23) or conventional overground therapy (CT, n = 23). Ten healthy subjects were also studied. Blood samples were collected to determine lactate, pyruvate, and glutathione levels and lactate/pyruvate ratio pre-post rehabilitation. In vivo muscle metabolism and endurance walking capacity were assessed by resting muscle oxygen consumption (rmVO 2 ) using near-infrared spectroscopy and by six-minute walking distance (6MWD), respectively. The levels of mitochondrial biomarkers and rmVO 2 , altered at baseline with respect to healthy subjects, improved after rehabilitation in the whole population. In the two groups, an enhanced response was observed after RAGT compared to CT for lactate ( p = 0.012), glutathione (<0.001), lactate/pyruvate ratio ( p = 0.08) and rmVO 2 ( p = 0.07). Metabolic biomarkers and 6MWD improvements were exclusively correlated with a training speed markedly below individual gait speed. In severely disabled MS patients, rehabilitation rebalanced altered serum metabolic and muscle parameters, with RAGT being more effective than CT. A determinable slow training speed was associated with better metabolic and functional recovery. Trial Registration: ClinicalTrials.gov NCT02421731.",2020,"The levels of mitochondrial biomarkers and rmVO 2 , altered at baseline with respect to healthy subjects, improved after rehabilitation in the whole population.","['Progressive Multiple Sclerosis', 'Ten healthy subjects', 'Forty-six progressive MS patients', 'severely disabled MS patients']","['12 walking sessions of robot-assisted gait training (RAGT, n = 23) or conventional overground therapy', 'Robot-Assisted Gait Training', 'Rehabilitation']","['lactate/pyruvate ratio', 'metabolic and functional recovery', 'lactate, pyruvate, and glutathione levels and lactate/pyruvate ratio pre-post rehabilitation', 'Metabolic biomarkers and 6MWD improvements', 'Abnormal levels of pyruvate and lactate', 'enhanced response']","[{'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0428617', 'cui_str': 'Lactate/pyruvate ratio measurement'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",10.0,0.0175828,"The levels of mitochondrial biomarkers and rmVO 2 , altered at baseline with respect to healthy subjects, improved after rehabilitation in the whole population.","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Manfredini', 'Affiliation': 'Department of Neuroscience and rehabilitation, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Straudi', 'Affiliation': 'Department of Neuroscience/Rehabilitation, Unit of Rehabilitation Medicine, University Hospital of Ferrara, 44124 Ferrara, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lamberti', 'Affiliation': 'Department of Neuroscience and rehabilitation, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Patergnani', 'Affiliation': 'Department of Medical Sciences, Laboratory for Technologies of Advanced Therapies (LTTA), University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tisato', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Secchiero', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bernardi', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ziliotto', 'Affiliation': 'School of Medicine and Surgery, University of Milano-Bicocca, 20900 Monza, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Marchetti', 'Affiliation': 'Department of Neuroscience and rehabilitation, University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Basaglia', 'Affiliation': 'Department of Neuroscience/Rehabilitation, Unit of Rehabilitation Medicine, University Hospital of Ferrara, 44124 Ferrara, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Bonora', 'Affiliation': 'Department of Medical Sciences, Laboratory for Technologies of Advanced Therapies (LTTA), University of Ferrara, 44121 Ferrara, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pinton', 'Affiliation': 'Department of Medical Sciences, Laboratory for Technologies of Advanced Therapies (LTTA), University of Ferrara, 44121 Ferrara, Italy.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics10100834']
1236,33081531,Effect of Empagliflozin on the Clinical Stability of Patients with Heart Failure and a Reduced Ejection Fraction: The EMPEROR-Reduced Trial.,"Background: Empagliflozin reduces the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure and a reduced ejection fraction, with or without diabetes, but additional data are needed about the effect of the drug on inpatient and outpatient events that reflect worsening heart failure. Methods: We randomly assigned 3730 patients with class II-IV heart failure with an ejection fraction of ≤40% to double-blind treatment with placebo or empagliflozin (10 mg once daily), in addition to recommended treatments for heart failure, for a median of 16 months. We prospectively collected information on inpatient and outpatient events reflecting worsening heart failure and prespecified their analysis in individual and composite endpoints. Results: Empagliflozin reduced the combined risk of death, hospitalization for heart failure or an emergent/urgent heart failure visit requiring intravenous treatment (415 vs 519 patients; empagliflozin vs placebo, respectively; hazard ratio 0.76, 95% CI: 0.67-0.87), P <0.0001. This benefit reached statistical significance at 12 days after randomization. Empagliflozin reduced the total number of heart failure hospitalizations that required intensive care (hazard ratio 0.67, 95% CI 0.50-0.90, P=0.008) and that required a vasopressor or positive inotropic drug or mechanical or surgical intervention (hazard ratio 0.64, 95% CI: 0.47-0.87, P=0.005). As compared with placebo, fewer patients in the empagliflozin group reported intensification of diuretics (297 vs 414), hazard ratio 0.67, 95% CI: 0.56-0.78, P<0.0001. Additionally, patients assigned to empagliflozin were 20-40% more likely to experience an improvement in NYHA functional class and were 20-40% less likely to experience worsening of NYHA functional class, with statistically significant effects that were apparent 28 days after randomization and maintained during long-term follow-up. The risk of any inpatient or outpatient worsening heart failure event in the placebo group was high (48.1 per 100 patient-years of follow-up), and it was reduced by empagliflozin (hazard ratio 0.70, 95% CI: 0.63-0.78), P<0.0001. Conclusions: In patients with heart failure and a reduced ejection fraction, empagliflozin reduced the risk and total number of inpatient and outpatient worsening heart failure events, with benefits seen early after initiation of treatment and sustained for the duration of double-blind therapy. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03057977.",2020,"Empagliflozin reduced the combined risk of death, hospitalization for heart failure or an emergent/urgent heart failure visit requiring intravenous treatment (415 vs 519 patients; empagliflozin vs placebo, respectively; hazard ratio 0.76, 95% CI: 0.67-0.87), P <0.0001.","['patients with heart failure and a reduced ejection fraction', '3730 patients with class II-IV heart failure with an ejection fraction of ≤40% to double-blind treatment with', 'patients with heart failure and a reduced ejection fraction, with or without diabetes', 'Patients with Heart Failure and a Reduced Ejection Fraction']","['empagliflozin', 'placebo or empagliflozin', 'placebo', 'Empagliflozin', 'empagliflozin vs placebo']","['NYHA functional class', 'risk of any inpatient or outpatient worsening heart failure event', 'combined risk of death, hospitalization for heart failure or an emergent/urgent heart failure visit requiring intravenous treatment', 'intensification of diuretics', 'risk and total number of inpatient and outpatient worsening heart failure events', 'total number of heart failure hospitalizations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",3730.0,0.565204,"Empagliflozin reduced the combined risk of death, hospitalization for heart failure or an emergent/urgent heart failure visit requiring intravenous treatment (415 vs 519 patients; empagliflozin vs placebo, respectively; hazard ratio 0.76, 95% CI: 0.67-0.87), P <0.0001.","[{'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': ''}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK), and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi School of Medicine, Jackson, MS.'}, {'ForeName': 'Gerasimos S', 'Initials': 'GS', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens, Greece.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'Université de Lorraine, Inserm INI-CRCT, CHRU, Nancy, France.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London UK.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Carson', 'Affiliation': 'Washington DC Veterans Affairs Medical Center, Washington DC.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiology, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Doehner', 'Affiliation': 'Department of Cardiology (CVK), and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Haass', 'Affiliation': 'Theresienkrankenhaus and St.Hedwig-Klinik, Mannheim, Germany.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Komajda', 'Affiliation': 'Department of Cardiology, Hospital Saint Joseph, Paris, France.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Miller', 'Affiliation': 'University of Florida, Jacksonville, FL.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Pehrson', 'Affiliation': 'Department of Cardiology, University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California, San Diego, CA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH and Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Waheed', 'Initials': 'W', 'LastName': 'Jamal', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Zeller', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schnaidt', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Université de Lorraine, Inserm INI-CRCT, CHRU, Nancy, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.051783']
1237,33081849,Safety and efficacy of antiviral combination therapy in symptomatic patients of Covid-19 infection - a randomised controlled trial (SEV-COVID Trial): A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES
1. To compare the safety and efficacy of Hydroxychloroquine with Ribavirin and standard treatment in patients with non-severe COVID-19 infection 2. To compare the safety and efficacy of standard treatment, Lopinavir-ritonavir with Ribavarin, and Hydroxychloroquine with Ribavirin in patients with severe COVID-19 infection TRIAL DESIGN: The study is an Open label, Parallel arm design, stratified randomised controlled trial. Patients will be categorised as non-severe or severe based on predefined criteria. Those who satisfy all inclusion criteria and no exclusion criteria in the respective categories, will be randomly assigned to one of the three treatment groups in a ratio of 1:1 in the non-severe category and 1:1:1 in the severe category.
PARTICIPANTS
The trial will be undertaken in a tertiary care center of the country where both Covid and non-Covid patients are getting treated. All patients who are confirmed positive and admitted will be screened for the eligibility criteria and will be enrolled in the study after a written informed consent. Patients will be categorised as non-severe or severe based on predefined criteria.
INCLUSION CRITERIA (ALL REQUIRED)
1. Age ≥18 years at time of participation in the study 2. Laboratory (RT-PCR) confirmed infection with SARS-CoV-2 3. Symptomatic (severe or non-severe) Covid-19 disease 4. Willingness of study participant to accept randomization to any assigned treatment arm EXCLUSION CRITERIA: 1. Use of medications that are contraindicated with Lopinavir/Ritonavir, Hydroxychloroquine/Chloroquine, or Ribavirin and that cannot be replaced or stopped 2. Patient already on antiretroviral therapy with Lopinavir-Ritonavir based regimen or on Hydroxychloroquine/Chloroquine or on Ribavirin 3. Any known contraindication to test drugs such as retinopathy and QT prolongation 4. Known allergic reaction or inability to take orally of Lopinavir-ritonavir, Hydroxychloroquine/ Chloroquine, Ribavarin 5. Pregnant or breastfeeding females 6. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within 30 days prior to participation in the present study or want to participate after enrolment INTERVENTION AND COMPARATOR: Two therapeutic interventions for non-severe category and three for severe category as described below NON-SEVERE TREATMENT ARMS (NS-GROUP): Treatment Arm Drug A Standard Treatment (ST NS ) B Hydroxychloroquine 400 mg twice on first day followed by 400 mg per oral daily for 10 days + Ribavirin (1.2 g orally as a loading dose followed by 600mg orally every 12 hours) for 10 days + Standard Treatment (ST NS ) Standard Treatment for non-severe cases (STNS): Strict Isolation, Standard Precautions (Hand hygiene, Cough Etiquette, Wear surgical mask), Hydration, Proper Nutrition, Supportive Pharmacotherapy (Antipyretic, Antiallergic, Cough Suppressant), Treatment of Comorbid Diseases, Oseltamivir (75 mg BD) for patients who are tested positive for H1N1.
SEVERE GROUP TREATMENT ARMS (S-GROUP)
Treatment Arm Drug A Standard Treatment (ST s ) B Hydroxychloroquine 400mg BD on day1 followed by 400 mg once daily + Ribavirin (1.2 g orally as a loading dose followed by 600mg orally every 12 hours) for 10 days + Standard Treatment (ST s ) C Lopinavir(200mg) + Ritonavir (50mg) two tablets twice daily+ Ribavirin (1.2g orally as a loading dose followed by 600mg orally every 12 hours) for 10 days + Standard Treatment (ST s ) 6 Standard Treatment for severe patients (STs): Strict Isolation, Standard Precautions (Hand hygiene, Cough Etiquette, Wear surgical mask), Fluid Therapy, Supportive Pharmacotherapy (Antipyretic, Antiallergic, Cough Suppressant), Oxygen supplementation (As required), Invasive ventilation (As required), Antibiotic agents for other associated infections (according to 2019 ATS/IDSA guidelines for non-ICU and ICU patients), Vasopressor support, Renal-replacement therapy, Treatment of Comorbid Diseases, Oseltamivir (75 mg BD) for patients who are tested positive for H1N1.
MAIN OUTCOMES
Primary endpoints: (1) Time to Clinical recovery (TTCR) defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, oxygen saturation, and alleviation of cough, sustained for at least 72 hours. (2) Time to SARS-CoV-2 RT-PCR negative in upper respiratory tract specimen, time to laboratory recovery of each organ involvement. Secondary Endpoints: All causes mortality, Frequency of respiratory progression (defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support), time to defervescence (in those with fever at enrolment), frequency of requirement for supplemental oxygen or non-invasive ventilation, frequency of requirement for mechanical ventilation, frequency of serious adverse events as per DAIDS table grade of severity. Outcomes are monitored for 28 days from the time of enrolment into the study OR until the patient is discharged or death whichever is longer.
RANDOMIZATION
The randomization will be done using a secured central computer-based randomization using a secure website using a central, computer-based randomisation program in a ratio of 1:1 in the non-severe category and 1:1:1 in the severe category.
BLINDING (MASKING)
This is an open labelled study i.e. Study assigned treatment will be known to the research team, the investigators and participants.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
Since it is an exploratory trial as COVID-19 being a new disease, all patients who came under the purview of the inclusion criteria within the study period (5 months duration of the recruitment period of the total 6 months duration of the study i.e. from the month of June, 2020 to October 2020) and who have consented for the study will be included.
TRIAL STATUS
Protocol version:1.0 Recruitment start: June 3 rd , 2020 (Ongoing) Recruitment finish (expected): October 31 st , 2020 TRIAL REGISTRATION: Clinical Trial Registry of India (CTRI): CTRI/2020/06/025575 . Registration on 03 June 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.",2020,Laboratory (RT-PCR) confirmed infection with SARS-CoV-2 3.,"['patients with non-severe COVID-19 infection 2', 'Age ≥18 years at time of participation in the study 2', 'patients with severe COVID-19 infection', 'patients who came under the purview of the inclusion criteria within the study period (5 months duration of the recruitment period of the total 6 months duration of the study i.e. from the month of June, 2020 to October 2020) and who have consented for the study will be included', '03 June 2020', 'Pregnant or breastfeeding females 6', 'symptomatic patients of Covid-19 infection - a randomised controlled trial (SEV-COVID Trial', 'All patients who are confirmed positive and admitted will be screened for the eligibility criteria and will be enrolled in the study after a written informed consent', 'patients who are tested positive for H1N1', 'non-severe cases (STNS']","['antiviral combination therapy', 'B Hydroxychloroquine', 'Hydroxychloroquine/Chloroquine', 'Lopinavir-ritonavir with Ribavarin, and Hydroxychloroquine with Ribavirin', 'Fluid Therapy, Supportive Pharmacotherapy (Antipyretic, Antiallergic, Cough Suppressant), Oxygen supplementation (As required), Invasive ventilation (As required), Antibiotic agents for other associated infections (according to 2019 ATS/IDSA guidelines for non-ICU and ICU patients), Vasopressor support, Renal-replacement therapy, Treatment of Comorbid Diseases, Oseltamivir', 'Hydroxychloroquine with Ribavirin', 'Hydroxychloroquine', ' Ribavirin', 'Ribavirin 3', 'Ritonavir', 'Ribavirin', 'Lopinavir/Ritonavir, Hydroxychloroquine/Chloroquine, or Ribavirin', 'daily+ Ribavirin', 'Lopinavir-Ritonavir', 'Drug A Standard Treatment (ST NS ', 'Lopinavir-ritonavir, Hydroxychloroquine/ Chloroquine, Ribavarin 5']","['Safety and efficacy', 'safety and efficacy', 'mortality, Frequency of respiratory progression', '1) Time to Clinical recovery (TTCR) defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, oxygen saturation, and alleviation of cough, sustained for at least 72 hours']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0436313', 'cui_str': 'Supportive pharmacotherapy'}, {'cui': 'C0003419', 'cui_str': 'Antipyretic Agents'}, {'cui': 'C0282555', 'cui_str': 'Antiallergy Agents'}, {'cui': 'C0003449', 'cui_str': 'Antitussive agent'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0558288', 'cui_str': 'As required'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C1292423', 'cui_str': '72 hours'}]",,0.180975,Laboratory (RT-PCR) confirmed infection with SARS-CoV-2 3.,"[{'ForeName': 'Prasan Kumar', 'Initials': 'PK', 'LastName': 'Panda', 'Affiliation': 'General Medicine, AIIMS Rishikesh, Rishikesh, India. prasan.med@aiimsrishikesh.edu.in.'}, {'ForeName': 'Arkapal', 'Initials': 'A', 'LastName': 'Bandyopadhyay', 'Affiliation': 'Department of Pharmacology, AIIMS Rishikesh, Rishikesh, India.'}, {'ForeName': 'Budha Charan', 'Initials': 'BC', 'LastName': 'Singh', 'Affiliation': 'Department of Medicine, AIIMS Rishikesh, Rishikesh, India.'}, {'ForeName': 'Bikram', 'Initials': 'B', 'LastName': 'Moirangthem', 'Affiliation': 'Department of Medicine, AIIMS Rishikesh, Rishikesh, India.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Chikara', 'Affiliation': 'Department of Pharmacology, AIIMS Rishikesh, Rishikesh, India.'}, {'ForeName': 'Sarama', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Biochemistry, AIIMS Rishikesh, Rishikesh, India.'}, {'ForeName': 'Yogesh Arvind', 'Initials': 'YA', 'LastName': 'Bahurupi', 'Affiliation': 'Community and Family Medicine, AIIMS Rishikesh, Rishikesh, India.'}]",Trials,['10.1186/s13063-020-04774-5']
1238,33066601,Acute Effects of Self-Selected Music Intervention on Golf Performance and Anxiety Level in Collegiate Golfers: A Crossover Study.,"Music has been reported as a positive intervention for improving psychophysiological conditions and exercise performance. However, the effects of music intervention on golf performance in association with psychophysiological responses have not been well examined in the literature. The purpose of the study was to investigate the acute effects of self-selected music intervention on golf swing and putting performance, heart rate (HR), HR variability (HRV), and anxiety. Twenty collegiate golfers voluntarily participated in this study (age = 20.2 ± 1.4 years, height = 171.7 ± 8.0 cm, body weight = 69.5 ± 14.6 kg, golf experience = 7.5 ± 2.1 years). A cross-over and within-subject design was used in this study. Participants performed a non-music trial (T1), pre-exercise music trial (T2), and simultaneous music trial (T3) in a randomized order with 48-72 h apart. The participants were attached to a HR monitor to record the HR and HRV during the measurement. The golf swing and putting performance was assessed by using the Golfzon golf simulator system. The state-trait anxiety inventory-state questionnaire (STAI-S) was used to evaluate anxiety state. All measurements were taken during baseline (phase one) and after resting or music intervention (phase two). Repeated measurement of analysis of variance (ANOVA) and Cohen's effect size (ES) were used for statistical analyses. The results show no significant differences in golf swing and putting performance ( p > 0.05). However, significant decrease in STAI-S score was found in T2 ( p = 0.047, ES = 0.32). A significant increase in the standard deviation of normal R-R interval (SDNN), low-frequency power spectrum (LF), standard deviation of along the line-of-identity (SD2) in T2 and T3 were observed ( p < 0.05). In conclusion, a single pre-exercise or simultaneous self-selected music intervention contributes minor effects to golf performance in collegiate golfers. The positive benefits of self-selected music intervention on the psychological condition and cardia-related modulation while practicing golf is warranted.",2020,"A significant increase in the standard deviation of normal R-R interval (SDNN), low-frequency power spectrum (LF), standard deviation of along the line-of-identity (SD2) in T2 and T3 were observed ( p < 0.05).","['Twenty collegiate golfers voluntarily participated in this study (age = 20.2 ± 1.4 years, height = 171.7 ± 8.0 cm, body weight = 69.5 ± 14.6 kg, golf experience = 7.5 ± 2.1 years', 'Collegiate Golfers']","['Self-Selected Music Intervention', 'self-selected music intervention', 'music intervention']","['STAI-S score', 'golf swing and putting performance', 'standard deviation of normal R-R interval (SDNN), low-frequency power spectrum (LF), standard deviation of along the line-of-identity (SD2', 'Golf Performance and Anxiety Level', 'golf swing and putting performance, heart rate (HR), HR variability (HRV), and anxiety', 'state-trait anxiety inventory-state questionnaire (STAI-S']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517642', 'cui_str': '20.2'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018041', 'cui_str': 'Golfing'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4068876', 'cui_str': '2.1'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018041', 'cui_str': 'Golfing'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0512171,"A significant increase in the standard deviation of normal R-R interval (SDNN), low-frequency power spectrum (LF), standard deviation of along the line-of-identity (SD2) in T2 and T3 were observed ( p < 0.05).","[{'ForeName': 'Hung-Tsung', 'Initials': 'HT', 'LastName': 'Wang', 'Affiliation': 'Graduate Institute of Sports Training, University of Taipei, Taipei 11153, Taiwan.'}, {'ForeName': 'Hsia-Ling', 'Initials': 'HL', 'LastName': 'Tai', 'Affiliation': 'Department of Physical Education, University of Taipei, Taipei 10048, Taiwan.'}, {'ForeName': 'Chia-Chen', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Graduate Institute of Sports Training, University of Taipei, Taipei 11153, Taiwan.'}, {'ForeName': 'Yung-Sheng', 'Initials': 'YS', 'LastName': 'Chen', 'Affiliation': 'Department of Exercise and Health Sciences, University of Taipei, Taipei 11153, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17207478']
1239,33067856,"Evaluating the effectiveness of the smartphone app, Drink Less, compared with the NHS alcohol advice webpage, for the reduction of alcohol consumption among hazardous and harmful adult drinkers in the UK at six-month follow-up: protocol for a randomised controlled trial.","BACKGROUND AND AIMS
Digital interventions are effective for reducing alcohol consumption but evidence is limited regarding smartphone apps. Drink Less is a theory- and evidence-informed app to help people reduce their alcohol consumption that has been refined in terms of its content and design for usability across the socio-demographic spectrum. We aim to evaluate the effectiveness and cost-effectiveness of recommending Drink Less at reducing alcohol consumption compared with usual digital care.
DESIGN
Two-arm individually randomised controlled trial.
SETTING
Online trial in the UK.
PARTICIPANTS
Hazardous or harmful drinkers (Alcohol Use Disorders Identification Test [AUDIT] score >=8) aged 18+ who want to drink less alcohol (n=5,562). Participants will be recruited from July 2020 to May 2022 using multiple strategies with a focus on remote digital methods.
INTERVENTION AND COMPARATOR
Participants will be randomised to receive either an email recommending that they use Drink Less (intervention) or view the NHS webpage on alcohol advice (comparator).
MEASUREMENTS
The primary outcome is change in self-reported weekly alcohol consumption, assessed using the extended AUDIT-Consumption, between baseline and 6-month follow-up. Secondary outcomes include change in self-reported weekly alcohol consumption assessed at 1 and 3-month follow-ups, and the proportion of hazardous drinkers; alcohol-related problems and injury; health-related quality of life; and use of health services assessed at 6-month follow-up. Effectiveness will be examined with adjusted regression models, adjusting for baseline alcohol consumption and using an intention-to-treat approach. A mixed-methods process evaluation will assess engagement, acceptability and mechanism of action. Economic evaluations will be conducted using both a short- and longer-term time horizon.
COMMENTS
This study will establish the effectiveness and cost-effectiveness of the Drink Less app at reducing alcohol consumption among hazardous and harmful adult drinkers and will be the first randomised controlled trial of an alcohol reduction app for the general population in the UK. This study will inform the decision on whether it is worth investing resources in large-scale implementation.",2020,"Secondary outcomes include change in self-reported weekly alcohol consumption assessed at 1 and 3-month follow-ups, and the proportion of hazardous drinkers; alcohol-related problems and injury; health-related quality of life; and use of health services assessed at 6-month follow-up.","['Participants will be recruited from July 2020 to May 2022 using multiple strategies with a focus on remote digital methods', 'Hazardous or harmful drinkers (Alcohol Use Disorders Identification Test [AUDIT] score >=8) aged 18+ who want to drink less alcohol (n=5,562', 'hazardous and harmful adult drinkers']",['email recommending that they use Drink Less (intervention) or view the NHS webpage on alcohol advice (comparator'],"['alcohol consumption', 'effectiveness and cost-effectiveness', 'change in self-reported weekly alcohol consumption assessed at 1 and 3-month follow-ups, and the proportion of hazardous drinkers; alcohol-related problems and injury; health-related quality of life; and use of health services', 'change in self-reported weekly alcohol consumption, assessed using the extended AUDIT-Consumption']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C2732658', 'cui_str': 'Alcohol use disorders identification test score'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.143132,"Secondary outcomes include change in self-reported weekly alcohol consumption assessed at 1 and 3-month follow-ups, and the proportion of hazardous drinkers; alcohol-related problems and injury; health-related quality of life; and use of health services assessed at 6-month follow-up.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Garnett', 'Affiliation': 'University College London, Gower Street, London, WC1E 6BT.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Oldham', 'Affiliation': 'University College London, Gower Street, London, WC1E 6BT.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Angus', 'Affiliation': 'University of Sheffield, Western Bank, Sheffield, S10 2TN.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Beard', 'Affiliation': 'University College London, Gower Street, London, WC1E 6BT.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Burton', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Field', 'Affiliation': 'University of Sheffield, Western Bank, Sheffield, S10 2TN.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Greaves', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hickman', 'Affiliation': 'University of Bristol, Beacon House, Queens Road, Bristol, BS8 1QU.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kaner', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, NE1 7RU.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Loebenberg', 'Affiliation': 'University College London, Gower Street, London, WC1E 6BT.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Michie', 'Affiliation': 'University College London, Gower Street, London, WC1E 6BT.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Munafò', 'Affiliation': 'University of Bristol, Beacon House, Queens Road, Bristol, BS8 1QU.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pizzo', 'Affiliation': 'University College London, Gower Street, London, WC1E 6BT.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'University College London, Gower Street, London, WC1E 6BT.'}]","Addiction (Abingdon, England)",['10.1111/add.15287']
1240,33068901,"Facilitating Activity and Self-management for people with Arthritic knee, hip or lower back pain (FASA): A cluster randomised controlled trial.","BACKGROUND
Chronic musculoskeletal pain including osteoarthritis (OA) can significantly limit the functional independence of individuals. The spine and hip and knee are predominantly affected; management guidelines for each recommend exercise and education to support self-management.
OBJECTIVES
This study investigated the effectiveness of a generic exercise and self-management intervention for people over-50 with hip/knee OA and/or lower back pain compared to continued GP management.
DESIGN
Single blind, cluster randomised controlled trial.
METHOD
Participants who had previously consulted with hip/knee OA and/or chronic lower back pain were recruited from 45 GP practices in SW England. Practices were randomly allocated to receive continued GP care (control) or continued GP care and a 6-week group exercise and self-management intervention facilitated by a physiotherapist and located in a community-based physiotherapy department. The primary outcome measure was the Dysfunction Index of the Short Musculoskeletal Functional Assessment (DI-SMFA) measured at six month post-rehabilitation.
RESULTS
349 participants were recruited and allocated to the intervention (n = 170) or control (n = 179) arms; the attrition rate was 13% at the 6 month primary end-point. One minor adverse event in the intervention group that required no medical input was reported. Intervention arm participants reported better function at 6 months compared with continued GP management alone (-3.01 difference in DI-SMFA [95%CI -5.25, -0.76], p = 0.01).
CONCLUSIONS
A generic exercise and self-management intervention resulted in statistically significant changes in function after six-months compared with GP management alone, but clinical significance of these findings is less clear. This may be an effective way of managing group interventions for lower limb OA and chronic lower back pain.",2020,"A generic exercise and self-management intervention resulted in statistically significant changes in function after six-months compared with GP management alone, but clinical significance of these findings is less clear.","['people with Arthritic knee, hip or lower back pain (FASA', 'people over-50 with hip/knee OA and/or lower back pain', '349 participants', 'Participants who had previously consulted with hip/knee OA and/or chronic lower back pain were recruited from 45\xa0GP practices in SW England', 'Chronic musculoskeletal pain including osteoarthritis (OA']","['generic exercise and self-management intervention', 'continued GP care (control) or continued GP care and a 6-week group exercise and self-management intervention facilitated by a physiotherapist and located in a community-based physiotherapy department', 'continued GP management alone']","['Dysfunction Index of the Short Musculoskeletal Functional Assessment (DI-SMFA', 'attrition rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0587975', 'cui_str': 'Physiotherapy department'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",349.0,0.105192,"A generic exercise and self-management intervention resulted in statistically significant changes in function after six-months compared with GP management alone, but clinical significance of these findings is less clear.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Walsh', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK. Electronic address: Nicola.walsh@uwe.ac.uk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Phillips', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': ""Lang'o"", 'Initials': 'L', 'LastName': 'Odondi', 'Affiliation': 'Division of Cardiovascular Medicine, University of Nottingham, UK.'}, {'ForeName': 'Shea', 'Initials': 'S', 'LastName': 'Palmer', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Cramp', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Pollock', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Hurley', 'Affiliation': ""Faculty for Health, Social Care and Education. St George's University of London & Kingston University, UK.""}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102271']
1241,33073298,"Combination Treatment with Human Adipose Tissue Stem Cell-derived Exosomes and Fractional CO2 Laser for Acne Scars: A 12-week Prospective, Double-blind, Randomized, Split-face Study.","A variety of applications of human adipose tissue stem cell-derived exosomes have been suggested as novel cell-free therapeutic strategies in the regenerative and aesthetic medical fields. This study evaluated the clinical efficacy and safety of adipose tissue stem cell-derived exosomes as an adjuvant therapy after application of fractional CO2 laser for acne scars. A 12-week prospective, double-blind, randomized, split-face trial was performed. A total of 25 patients received 3 consecutive treatment sessions of fractional CO2 laser to the whole face, with a follow-up evaluation. Post-laser treatment regimens were applied; for each patient, one side of the face was treated with adipose tissue stem cell-derived exosomes gel and the other side was treated with control gel. Adipose tissue stem cell-derived exosomes-treated sides had achieved a significantly greater improvement than the control sides at the final follow-up visit (percentage reduction in échelle d'évaluation clinique des cicatrices d'acné scores: 32.5 vs 19.9%, p < 0.01). Treatment-related erythema was milder, and post-treatment downtime was shorter on the applications of human adipose tissue stem cell-derived exosomes-treated side. In conclusion, the combined use of this novel material with resurfacing devices would provide synergistic effects on both the efficacy and safety of atrophic acne scar treatments.",2020,"Adipose tissue stem cell-derived exosomes-treated sides had achieved a significantly greater improvement than the control sides at the final follow-up visit (percentage reduction in échelle d'évaluation clinique des cicatrices d'acné (ECCA) scores: 32.5 vs 19.9%, p < 0.01).","['acne scars', 'Acne Scars', '25 patients']","['fractional CO2 laser', 'Human Adipose Tissue Stem Cell-derived Exosomes and Fractional CO2 Laser', 'adipose tissue stem cell-derived exosomes gel and the other side was treated with control gel', 'adipose tissue stem cell-derived exosomes']",['Adipose tissue stem cell'],"[{'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C2350332', 'cui_str': 'Exosomes'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}]",25.0,0.0249087,"Adipose tissue stem cell-derived exosomes-treated sides had achieved a significantly greater improvement than the control sides at the final follow-up visit (percentage reduction in échelle d'évaluation clinique des cicatrices d'acné (ECCA) scores: 32.5 vs 19.9%, p < 0.01).","[{'ForeName': 'Hyuck Hoon', 'Initials': 'HH', 'LastName': 'Kwon', 'Affiliation': 'Oaro Dermatology Institute, Seoul, Korea.'}, {'ForeName': 'Steven Hoseong', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Byung Cheol', 'Initials': 'BC', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Kui Young', 'Initials': 'KY', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Jae Yoon', 'Initials': 'JY', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'Youin', 'Initials': 'Y', 'LastName': 'Bae', 'Affiliation': ''}, {'ForeName': 'Gyeong-Hun', 'Initials': 'GH', 'LastName': 'Park', 'Affiliation': ''}]",Acta dermato-venereologica,['10.2340/00015555-3666']
1242,33074590,"Efficacy and safety of linagliptin as add-on therapy to insulin in Chinese patients with type 2 diabetes mellitus: A randomized, double-blind, placebo-controlled trial.","This 24-week, double-blind, placebo-controlled, phase III trial evaluated the efficacy and safety of linagliptin in 206 Chinese patients with inadequately controlled (glycated haemoglobin [HbA1c] 7.5%-10.0%) type 2 diabetes mellitus (T2DM) receiving insulin (basal or premixed) ± metformin. Patients were randomized (1:1) to receive linagliptin 5 mg/d or placebo. The decrease from baseline in HbA1c (primary endpoint) was greater with linagliptin than with placebo (-0.61% vs. -0.20%, adjusted mean difference -0.40%; P = 0.0016). Linagliptin demonstrated significantly greater improvement in 2-hour postprandial glucose (-1.77 mmol/L [-31.95 mg/dL]; P < 0.001), and a numerical reduction in fasting plasma glucose (-0.34 mmol/L [-6.2 mg/dL]; P = 0.2241) versus placebo. Proportionally more patients on linagliptin achieved a HbA1c reduction of ≥0.5% versus those on placebo (odds ratio 2.293, P < 0.01). Adverse events in both groups were similar, with no new safety findings or clinically relevant changes in body weight. Among investigator-defined hypoglycaemic events (linagliptin: 17.3%; placebo: 12.7%; odds ratio 1.48, P = 0.337), none were severe. In Chinese patients with T2DM, linagliptin add-on to insulin improved glycaemic control and was well tolerated, without increased risk of hypoglycaemia or weight gain.",2020,"Linagliptin demonstrated significantly greater improvement in 2-hour postprandial glucose (-31.95 mg/dL; P <0.001), and a numerical reduction in fasting plasma glucose (-6.2 mg/dL; P = 0.2241) versus placebo.","['206 Chinese patients with inadequately controlled (glycated hemoglobin [HbA1c] 7.5-10.0%) type 2 diabetes mellitus (T2DM) receiving', 'Chinese patients with type 2 diabetes mellitus', 'Chinese patients with']","['linagliptin 5 mg/day or placebo', 'T2DM, linagliptin', 'Linagliptin', 'placebo', 'linagliptin', 'insulin (basal or premixed) ± metformin']","['2-hour postprandial glucose', 'efficacy and safety', 'Adverse events', 'hypoglycemic events', 'Efficacy and safety', 'body weight', 'fasting plasma glucose']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3153993', 'cui_str': 'Linagliptin 5 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",206.0,0.519777,"Linagliptin demonstrated significantly greater improvement in 2-hour postprandial glucose (-31.95 mg/dL; P <0.001), and a numerical reduction in fasting plasma glucose (-6.2 mg/dL; P = 0.2241) versus placebo.","[{'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""China-Japan Friendship Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Xiangjin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fujian, People's Republic of China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Lei', 'Affiliation': ""Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Nanjing First Hospital, Nanjing Medical University, Nanjing, People's Republic of China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Shengjing Hospital of China Medical University Endocrinology, Liaoning, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': ""Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, People's Republic of China.""}, {'ForeName': 'Binqi', 'Initials': 'B', 'LastName': 'Ye', 'Affiliation': ""Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, People's Republic of China.""}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': ""Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, People's Republic of China.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meinicke', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14231']
1243,33069784,"Rationale and design of a multicenter, randomized, patients-blinded two-stage clinical trial on effects of endothelial function test in patients with non-obstructive coronary artery disease (ENDOFIND).","Abnormal peripheral and coronary endothelial function has been associated with increased risk of major adverse cardiovascular events (MACE) in cross-sectional retrospective and observational studies. However, prognostic value of routine clinical evaluation, diagnosis and treatment of endothelial dysfunction on incident MACE in patients with non-obstructive coronary artery disease (NOCAD) remains unknown. Endothelial Function Guided Management in Patients with NOCAD (ENDOFIND) is a multicenter, randomized, patients-blinded, parallel-controlled, two-stage clinical trial evaluating the impact of routine clinical peripheral endothelial function testing on initiation and/or intensification of cardiovascular preventive therapies in Stage I, and on the risk of MACE in Stage II in patients with NOCAD. One thousand participants with NOCAD on clinically indicated coronary computed tomography or invasive angiography will be enrolled and randomized 1:1, after baseline peripheral endothelial function evaluation, to either endothelial function guided treatment group or standard of care control group. In Stage I, patients will be followed for 12 months and primary outcome will be the proportion of patients receiving prescriptions for cardiovascular evidence-based lipid, blood pressure and glucose lowering medications at the clinic visit immediately after endothelial function evaluation. Secondary outcomes are change in endothelial function measured as reactive hyperemia index and patients' adherence to evidence-based medications in 12 months. Study will be extended into Stage II where sample size and follow up duration will be reevaluated to ensure statistical power, and primary outcome will be incident MACE. ENDOFIND is proof-of-concept clinical trial of a disruptive endothelial function guided clinical intervention with potential benefits to NOCAD patients. CONDENSED ABSTRACT: ENDOFIND is a proof-of-concept clinical trial of a disruptive endothelial function guided clinical intervention with potential benefits to patients with no obstructive coronary artery disease (NOCAD). It is a multicenter, randomized, patients-blinded, parallel controlled two-stage clinical trial to evaluate the impact of routine clinical peripheral endothelial function testing on initiation and/or intensification of cardiovascular disease preventive therapies in Stage I, and on the risk of MACE in Stage II.",2020,Abnormal peripheral and coronary endothelial function has been associated with increased risk of major adverse cardiovascular events (MACE) in cross-sectional retrospective and observational studies.,"['One thousand participants with NOCAD on clinically indicated coronary computed tomography or invasive angiography', 'Patients with NOCAD', 'patients with non-obstructive coronary artery disease (NOCAD', 'patients with no obstructive coronary artery disease (NOCAD', 'patients with non-obstructive coronary artery disease (ENDOFIND', 'NOCAD patients', 'patients with NOCAD']","['endothelial function test', 'endothelial function guided treatment group or standard of care control group']","['proportion of patients receiving prescriptions for cardiovascular evidence-based lipid, blood pressure and glucose lowering medications', ""change in endothelial function measured as reactive hyperemia index and patients' adherence to evidence-based medications""]","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",1000.0,0.232493,Abnormal peripheral and coronary endothelial function has been associated with increased risk of major adverse cardiovascular events (MACE) in cross-sectional retrospective and observational studies.,"[{'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Vascular Medicine Center, Peking University Shougang Hospital, Beijing, PR China; Vascular Health Research Center of Peking University Health Science Center(VHRC-PKUHSC), Beijing, PR China.'}, {'ForeName': 'Gaoqiang', 'Initials': 'G', 'LastName': 'Xie', 'Affiliation': 'Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, PR China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Vascular Medicine Center, Peking University Shougang Hospital, Beijing, PR China.'}, {'ForeName': 'Jinbo', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Vascular Medicine Center, Peking University Shougang Hospital, Beijing, PR China; Vascular Health Research Center of Peking University Health Science Center(VHRC-PKUHSC), Beijing, PR China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Vascular Medicine Center, Peking University Shougang Hospital, Beijing, PR China.'}, {'ForeName': 'Michel T', 'Initials': 'MT', 'LastName': 'Corban', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Lerman', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Vascular Health Research Center of Peking University Health Science Center(VHRC-PKUHSC), Beijing, PR China; Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, PR China. Electronic address: wuyf@bjmu.edu.cn.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Vascular Medicine Center, Peking University Shougang Hospital, Beijing, PR China; Vascular Health Research Center of Peking University Health Science Center(VHRC-PKUHSC), Beijing, PR China; Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, PR China; Key Laboratory of Molecular Cardiovascular Sciences (Peking University), Ministry of Education, Beijing, PR China. Electronic address: dr.hongyuwang@foxmail.com.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.10.033']
1244,33070009,A trial of buspirone for anxiety in Parkinson's disease: Safety and tolerability.,"INTRODUCTION
In Parkinson's disease (PD), anxiety is common, associated with lower health-related quality of life, and undertreated. The primary objective of this study was to determine the tolerability of buspirone for the treatment of anxiety in PD.
METHODS
Individuals with PD and clinically significant anxiety were randomized 4:1 to flexible dosage buspirone or placebo for 12 weeks. Treatment was initiated at 7.5 mg twice daily and titrated based on response and tolerability to an optimal dosage (maximum 30 mg twice daily). The primary outcome was the proportion of participants who failed to complete the study on study drug. Secondary outcomes included adverse events, dosage reductions, motor function, dyskinesias, and anxiety.
RESULTS
A total of 21 participants enrolled, 4 were randomized to placebo and 17 to buspirone (mean (SD) age 65.5 (9.8), 76.5% male, 88% on concomitant antidepressant or anxiolytic). In the buspirone group, 7 (41%) failed to complete the study on drug, 5 due to intolerability. The median buspirone dosage was 7.5 mg twice daily. No serious adverse events occurred. A total of 9 (53%) buspirone participants experienced adverse events consistent with worsened motor function. In the buspirone group, mean (SD) improvement from baseline to week 12 in Hamilton Anxiety Rating Scale was -3.9 (3.8) and Parkinson Anxiety Scale -7.1 (6.4).
CONCLUSION
Tolerability concerns do not support moving immediately forward with a large-scale efficacy trial. However, concomitant anxiolytics may have affected tolerability and a signal of efficacy was seen suggesting that future studies of buspirone monotherapy be considered.",2020,"In the buspirone group, mean (SD) improvement from baseline to week 12 in Hamilton Anxiety Rating Scale was -3.9 (3.8) and Parkinson Anxiety Scale -7.1 (6.4).
","[""Parkinson's disease"", 'Individuals with PD and clinically significant anxiety', 'mean (SD) age 65.5 (9.8), 76.5% male, 88% on concomitant antidepressant or anxiolytic', 'A total of 21 participants enrolled, 4 were randomized to']","['flexible dosage buspirone or placebo', 'placebo', 'buspirone']","['Parkinson Anxiety Scale', 'adverse events', 'tolerability', 'Hamilton Anxiety Rating Scale', 'adverse events, dosage reductions, motor function, dyskinesias, and anxiety']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]",21.0,0.0671081,"In the buspirone group, mean (SD) improvement from baseline to week 12 in Hamilton Anxiety Rating Scale was -3.9 (3.8) and Parkinson Anxiety Scale -7.1 (6.4).
","[{'ForeName': 'Ruth B', 'Initials': 'RB', 'LastName': 'Schneider', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Blvd, Box MIND, Rochester, NY, 14642, USA. Electronic address: ruth_schneider@urmc.rochester.edu.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Auinger', 'Affiliation': 'Center for Health and Technology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Blvd, Box 694, Rochester, NY, USA. Electronic address: peggy.auinger@chet.rochester.edu.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Tarolli', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Blvd, Box MIND, Rochester, NY, 14642, USA. Electronic address: christopher_tarolli@urmc.rochester.edu.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Iourinets', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 919 Westfall Rd, Building C, Suite 100, Rochester, NY, 14618, USA. Electronic address: jiourine@u.rochester.edu.'}, {'ForeName': 'María Cristina', 'Initials': 'MC', 'LastName': 'Gil-Díaz', 'Affiliation': 'Department of Neuroscience, University of Rochester, 500 Joseph C. Wilson Blvd, Rochester, NY, 14627, USA. Electronic address: mgildiaz@u.rochester.edu.'}, {'ForeName': 'Irene H', 'Initials': 'IH', 'LastName': 'Richard', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 919 Westfall Rd, Building C, Suite 100, Rochester, NY, 14618, USA. Electronic address: irene_richard@urmc.rochester.edu.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.10.020']
1245,33070045,Effects of a light therapy intervention on diurnal salivary cortisol in fatigued cancer survivors: A secondary analysis of a randomized controlled trial.,"OBJECTIVE
Altered diurnal cortisol rhythms are a potential mechanism through which symptoms of fatigue are maintained in post-treatment cancer survivors. Exposure to early morning bright light may target this underlying dysregulation, resulting in improved diurnal cortisol patterns, subsequently improving symptoms of fatigue. This research investigates the effects of a 4-week light therapy intervention on the diurnal cortisol slopes and output in fatigued cancer survivors.
METHODS
Post-treatment adult cancer survivors who met diagnostic criteria for cancer-related fatigue were randomly assigned to receive either a bright white light (BWL) or dim red light (DRL) device, used daily for 30 min over four consecutive weeks. Assessments of fatigue and salivary cortisol were collected at baseline and post-intervention. Cortisol was sampled four times per day (waking, noon, 5 pm, bedtime) for three days at each timepoint. Diurnal cortisol slopes and total cortisol output were calculated at baseline and post-intervention. Linear mixed models were used to analyze the data.
RESULTS
Seventy-seven participants were included in this analysis (BWL n = 40; DRL n = 37). Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01, Cohen's d = 0.57) and increased total cortisol output (B = 9.58, p = .03, Cohen's d = 0.49) from baseline to post-intervention, indicating only a moderate effect of time. Neither diurnal cortisol slopes nor total cortisol output mediated the relationship between the light therapy intervention and fatigue levels.
CONCLUSION
Though the results of this trial are promising for light therapy as an effective intervention to reduce fatigue in cancer survivors, this does not appear to be achieved through alterations in neuroendocrine function. ClinicalTrials.gov registration #: NCT01780623.",2020,"Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01,","['Seventy-seven participants', 'cancer survivors', 'Post-treatment adult cancer survivors who met diagnostic criteria for cancer-related fatigue', 'fatigued cancer survivors']","['light therapy intervention', 'bright white light (BWL) or dim red light (DRL) device']","['diurnal cortisol slopes nor total cortisol output', 'Diurnal cortisol slopes and total cortisol output', 'total cortisol output', 'steepness in cortisol slope', 'fatigue and salivary cortisol', 'diurnal salivary cortisol', 'diurnal cortisol slopes']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",77.0,0.241495,"Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01,","[{'ForeName': 'Jillian A', 'Initials': 'JA', 'LastName': 'Johnson', 'Affiliation': 'Department of Biobehavioral Health, Pennsylvania State University, State College, PA, USA. Electronic address: jaj53@psu.edu.'}, {'ForeName': 'Utkarsh', 'Initials': 'U', 'LastName': 'Subnis', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Electronic address: utkarsh.subnis@ucalgary.ca.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Carlson', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Psychology, University of Calgary, Calgary, AB, Canada. Electronic address: lcarlso@ucalgary.ca.'}, {'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Garland', 'Affiliation': ""Departments of Psychology and Oncology, Memorial University, St. John's, Newfoundland, Canada. Electronic address: sheila.garland@mun.ca.""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Santos-Iglesias', 'Affiliation': 'Department of Psychology, Cape Breton University, Sydney, NS, Canada. Electronic address: pablo_santos@cbu.ca.'}, {'ForeName': 'Katherine-Ann L', 'Initials': 'KL', 'LastName': 'Piedalue', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Electronic address: klpiedal@ucalgary.ca.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Deleemans', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Division of Medical Science, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Electronic address: julie.deleemans@ucalgary.ca.'}, {'ForeName': 'Tavis S', 'Initials': 'TS', 'LastName': 'Campbell', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Psychology, University of Calgary, Calgary, AB, Canada. Electronic address: t.s.campbell@ucalgary.ca.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110266']
1246,33070053,"Combination of gefitinib and olaparib versus gefitinib alone in EGFR mutant non-small-cell lung cancer (NSCLC): A multicenter, randomized phase II study (GOAL).","OBJECTIVES
Progression-free survival (PFS) and response rate to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) varies in patients with non-small-cell lung cancer (NSCLC) driven byEGFR mutations, suggesting that other genetic alterations may influence oncogene addiction. Low BRCA1 mRNA levels correlate with longer PFS in erlotinib-treated EGFR-mutant NSCLC patients. Since the poly (ADP-ribose) polymerase (PARP) inhibitor, olaparib, may attenuate and/or prevent BRCA1 expression, the addition of olaparib to gefitinib could improve outcome in EGFR-mutant advanced NSCLC.
MATERIALS AND METHODS
GOAL was a multicenter, randomized phase IB/II study performed in two countries, Spain and Mexico. Eligible patients were 18 years or older, treatment-naïve, pathologically confirmed stage IV NSCLC, with centrally confirmed EGFR mutations and measurable disease. Patients were randomly allocated (1:1) to receive gefitinib 250 mg daily or gefitinib 250 mg daily plus olaparib 200 mg three times daily in 28-day cycles. The primary endpoint was PFS. Secondary endpoints included overall survival (OS), response rate, safety and tolerability.
RESULTS
Between September 2013, and July 2016, 182 patients underwent randomization, 91 received gefitinib and 91 received gefitinib plus olaparib. There were no differences in gender, age, smoking status, performance status, presence of bone and brain metastases or type ofEGFR mutation. Median PFS was 10.9 months (95 % CI 9.3-13.3) in the gefitinib arm and 12.8 months (95 % CI 9.1-14.7) in the gefitinib plus olaparib arm (HR 1.38, 95 % CI 1.00-1.92; p = 0.124). The most common adverse events were anemia, 78 % in gefitinib plus olaparib group, 38 % in gefitinib arm, diarrhea, 65 % and 60 %, and fatigue, 40 % and 32 %, respectively.
CONCLUSIONS
The gefitinib plus olaparib combination did not provide significant benefit over gefitinib alone. The combination's safety profile showed an increase in hematological and gastrointestinal toxicity, compared to gefitinib alone, however, no relevant adverse events were noted.",2020,"The combination's safety profile showed an increase in hematological and gastrointestinal toxicity, compared to gefitinib alone, however, no relevant adverse events were noted.","['182 patients underwent randomization, 91 received', 'Between September 2013, and July 2016', 'patients with non-small-cell lung cancer (NSCLC) driven byEGFR mutations', 'two countries, Spain and Mexico', 'EGFR mutant non-small-cell lung cancer (NSCLC', 'Eligible patients were 18 years or older, treatment-naïve, pathologically confirmed stage IV NSCLC, with centrally confirmed EGFR mutations and measurable disease']","['gefitinib 250\u202fmg daily or gefitinib 250\u202fmg daily plus olaparib 200\u202fmg three times daily in 28-day cycles', 'epidermal growth factor receptor', 'EGFR) tyrosine kinase inhibitors (TKIs', 'gefitinib', 'gefitinib plus olaparib', 'gefitinib and olaparib versus gefitinib alone']","['diarrhea', 'Median PFS', 'hematological and gastrointestinal toxicity', 'PFS', 'overall survival (OS), response rate, safety and tolerability', 'gender, age, smoking status, performance status, presence of bone and brain metastases or type ofEGFR mutation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1176914', 'cui_str': 'gefitinib 250 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",182.0,0.184564,"The combination's safety profile showed an increase in hematological and gastrointestinal toxicity, compared to gefitinib alone, however, no relevant adverse events were noted.","[{'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Garcia-Campelo', 'Affiliation': 'University Hospital A Coruña (XXIAC-SERGAS), A Coruña, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Arrieta', 'Affiliation': 'Instituto Nacional de Cancerología, Mexico City, Mexico.'}, {'ForeName': 'Bartomeu', 'Initials': 'B', 'LastName': 'Massuti', 'Affiliation': 'Alicante University Hospital, Alicante, Spain.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodriguez-Abreu', 'Affiliation': 'Hospital Universitario Insular De Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Ana Laura Ortega', 'Initials': 'ALO', 'LastName': 'Granados', 'Affiliation': 'Complejo Hospitalario de Jaén, Jaén, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Lianes', 'Affiliation': 'Hospital de Mataró, Mataró, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bosch-Barrera', 'Affiliation': 'Catalan Institute of Oncology (ICO) and Girona Biomedical Research Institute (IDIBGi), Girona, Spain.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Insa', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Dómine', 'Affiliation': 'Hospital Universitario Fundación Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Reguart', 'Affiliation': ""Hospital Clínic Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Guirado', 'Affiliation': 'Hospital General de Elche, Elche, Alicante, Spain.'}, {'ForeName': 'María Ángeles', 'Initials': 'MÁ', 'LastName': 'Sala', 'Affiliation': 'Hospital Universitario de Basurto, Bilbao, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Vázquez-Estevez', 'Affiliation': 'Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Reyes Bernabé', 'Initials': 'RB', 'LastName': 'Caro', 'Affiliation': 'Hospital Virgen Del Rocio, Sevilla, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Drozdowskyj', 'Affiliation': 'Germans Trias i Pujol Research Institute and Hospital (IGTP), Badalona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Verdú', 'Affiliation': 'Spanish Lung Cancer Group Office, Barcelona, Spain.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Karachaliou', 'Affiliation': 'Laboratory of Oncology/Pangaea Oncology, Quiron Dexeus University Hospital, Barcelona, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Molina-Vila', 'Affiliation': 'Laboratory of Oncology/Pangaea Oncology, Quiron Dexeus University Hospital, Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': 'Germans Trias i Pujol Research Institute and Hospital (IGTP), Badalona, Spain. Electronic address: rrosell@iconcologia.net.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.09.018']
1247,33070057,Salivary measurement and mindfulness-based modulation of prescription opioid cue-reactivity.,"BACKGROUND
Chronic pain patients on long-term opioid therapy (LTOT) may be at elevated risk for developing conditioned opioid cue-reactivity as their prescribed dosing schedules simultaneously function as fixed reinforcement schedules. Since opioids are typically consumed orally during LTOT, it stands to reason that opioid cue exposure might elicit conditioned salivary responses. However, no study has examined salivary cue-reactivity among opioid users during in-vivo exposure to their own prescription opioid medication.
METHODS
Two samples (N = 68, N = 39) of chronic pain patients on LTOT were recruited from primary care and specialty care clinics. Study 1 aimed to determine whether chronic pain patients receiving LTOT exhibited salivary cue-reactivity to their prescribed opioid. Study 2 was a pilot study that aimed to assess the effects of behavioral treatment on chronic pain patients' salivary cue-reactivity.
RESULTS
In Study 1, exposure to the patient's own prescribed opioid resulted in significantly greater increases in salivation and cue-elicited craving than exposure to a neutral cue. In Study 2 participants who were randomized to an 8-week Mindfulness-Oriented Recovery Enhancement intervention evidenced significantly greater decreases in opioid cue-reactivity than participants in an active control condition as evidenced by both reduced salivation and craving ratings.
CONCLUSIONS
Study findings demonstrate salivation may serve as a useful, objective index of opioid cue-reactivity. With further refinement of this task, conditioned salivary response could be used to identify especially vulnerable patients, who then could be targeted with a personalized medicine approach for selective and intensive prevention/treatment interventions to preempt escalation of opioid use to opioid misuse and OUD.",2020,"In Study 2 participants who were randomized to an 8-week Mindfulness-Oriented Recovery Enhancement intervention evidenced significantly greater decreases in opioid cue-reactivity than participants in an active control condition as evidenced by both reduced salivation and craving ratings.
","['chronic pain patients receiving LTOT exhibited salivary cue-reactivity to their prescribed opioid', 'Chronic pain patients on long-term', ""chronic pain patients' salivary cue-reactivity"", 'Two samples (N = 68, N = 39) of chronic pain patients on LTOT were recruited from primary care and specialty care clinics']","['8-week Mindfulness-Oriented Recovery Enhancement intervention', 'behavioral treatment', 'opioid therapy (LTOT']","['salivation and cue-elicited craving', 'opioid cue-reactivity', 'salivation and craving ratings']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0036104', 'cui_str': 'Salivary secretion'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",2.0,0.0378235,"In Study 2 participants who were randomized to an 8-week Mindfulness-Oriented Recovery Enhancement intervention evidenced significantly greater decreases in opioid cue-reactivity than participants in an active control condition as evidenced by both reduced salivation and craving ratings.
","[{'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Hanley', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah, United States; College of Social Work, University of Utah, United States.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Garland', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah, United States; College of Social Work, University of Utah, United States; Salt Lake City Veterans Administration Medical Center, United States. Electronic address: eric.garland@socwk.utah.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108351']
1248,33077817,Enhanced physical and cognitive performance in active duty Airmen: evidence from a randomized multimodal physical fitness and nutritional intervention.,"Achieving military mission objectives requires high levels of performance from Airmen who operate under extreme physical and cognitive demands. Thus, there is a critical need to establish scientific interventions to enhance physical fitness and cognitive performance-promoting the resilience of Airmen and aiding in mission success. We therefore conducted a comprehensive, 12-week randomized controlled trial in active-duty Air Force Airmen (n = 148) to compare the efficacy of a multimodal intervention comprised of high-intensity interval aerobic fitness and strength training paired with a novel nutritional supplement [comprised of β-hydroxy β-methylbutyrate (HMB), lutein, phospholipids, DHA and selected micronutrients including B12 and folic acid] to high-intensity interval aerobic fitness and strength training paired with a standard of care placebo beverage. The exercise intervention alone improved several dimensions of physical fitness [strength and endurance (+ 8.3%), power (+ 0.85%), mobility and stability (+ 22%), heart rate (- 1.1%) and lean muscle mass (+ 1.4%)] and cognitive function [(episodic memory (+ 9.5%), processing efficiency (+ 7.5%), executive function reaction time (- 4.8%) and fluid intelligence accuracy (+ 19.5%)]. Relative to exercise training alone, the multimodal fitness and nutritional intervention further improved working memory (+ 9.0%), fluid intelligence reaction time (- 7.7%), processing efficiency (+ 1.8%), heart rate (- 2.4%) and lean muscle mass (+ 1.5%). These findings establish the efficacy of a multimodal intervention that incorporates aerobic fitness and strength training with a novel nutritional supplement to enhance military performance objectives and to provide optimal exercise training and nutritional support for the modern warfighter.",2020,"Relative to exercise training alone, the multimodal fitness and nutritional intervention further improved working memory (+ 9.0%), fluid intelligence reaction time (- 7.7%), processing efficiency (+ 1.8%), heart rate (- 2.4%) and lean muscle mass (+ 1.5%).","['active duty Airmen', 'active-duty Air Force Airmen (n\u2009=\u2009148']","['multimodal intervention comprised of high-intensity interval aerobic fitness and strength training paired with a novel nutritional supplement [comprised of β-hydroxy β-methylbutyrate (HMB), lutein, phospholipids, DHA and selected micronutrients including B12 and folic acid']","['lean muscle mass', 'processing efficiency', 'executive function reaction time', 'cognitive function [(episodic memory', 'fluid intelligence reaction time', 'fluid intelligence accuracy', 'mobility and stability', 'working memory', 'heart rate', 'several dimensions of physical fitness [strength and endurance', 'Enhanced physical and cognitive performance']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4521691', 'cui_str': 'US Military enlisted E2'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0233174,"Relative to exercise training alone, the multimodal fitness and nutritional intervention further improved working memory (+ 9.0%), fluid intelligence reaction time (- 7.7%), processing efficiency (+ 1.8%), heart rate (- 2.4%) and lean muscle mass (+ 1.5%).","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Zwilling', 'Affiliation': 'Decision Neuroscience Laboratory, University of Illinois, 405 North Mathews Avenue, Urbana, IL, 61801, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Strang', 'Affiliation': 'Applied Neuroscience Branch, Wright Patterson Air Force Base, Dayton, OH, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Anderson', 'Affiliation': 'Decision Neuroscience Laboratory, University of Illinois, 405 North Mathews Avenue, Urbana, IL, 61801, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Jurcsisn', 'Affiliation': 'Applied Neuroscience Branch, Wright Patterson Air Force Base, Dayton, OH, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': 'Applied Neuroscience Branch, Wright Patterson Air Force Base, Dayton, OH, USA.'}, {'ForeName': 'Tapas', 'Initials': 'T', 'LastName': 'Das', 'Affiliation': 'Discovery Research, Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Kuchan', 'Affiliation': 'Discovery Research, Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Aron K', 'Initials': 'AK', 'LastName': 'Barbey', 'Affiliation': 'Decision Neuroscience Laboratory, University of Illinois, 405 North Mathews Avenue, Urbana, IL, 61801, USA. barbey@illinois.edu.'}]",Scientific reports,['10.1038/s41598-020-74140-7']
1249,33077839,Adjuvant chemotherapy after radical nephroureterectomy improves the survival outcome of high-risk upper tract urothelial carcinoma patients with cardiovascular comorbidity.,"This prospective randomized comparative trial study aimed to evaluate the therapeutic outcomes of radical nephroureterectomy and adjuvant chemotherapy (ACT) used in combination in high risk upper tract urothelial carcinoma (UTUC) patients with cardiovascular comorbidity. Based on the inclusion criteria of high-risk UTUC in EAU guidelines (updated in 2014), all eligible patients treated in our hospital from January 2014 to March 2018 were included, and cases with late disease, renal dysfunction, severe cardiopulmonary disease or other malignant tumors were excluded. The cases were randomized into two groups based on treatment regimen. Multivariate analyses were performed to analyze the influencing factors of survival outcome in the enrolled patients. The Cox proportional-hazards model and the Kaplan-Meier method were employed to assess progression free survival (PFS), overall survival (OS) and cancer specific survival (CSS). In addition, the potential adverse effects of chemotherapy were actively monitored. A total of 176 high-risk UTUC individuals with cardiovascular comorbidity were enrolled and evaluated in this study. Median follow-up durations were 30 months (range 6-54) in the RNU (n = 82) group and 36 months (range 6-54) in the RNU + ACT (n = 94) group. Multivariable analysis indicated that peri-operative cardiovascular events risk grade was independent prognostic factor for OS. Tumor size was independent prognostic factor for PFS and CSS. BMI and lymphovacular invasion were significant predictors of PFS. Clinical stage, lymph node involvement, and tumor grade were significant predictors of PFS, OS and CSS in these patients. Especially, chemotherapy was helpful in improving PFS [P < 0.001, HR = 6.327 (5.115-7.793)], OS [P = 0.013, HR = 2.336 (1.956-2.883)] and CSS [P = 0.008, HR = 3.073 (2.533-3.738)]. Kaplan-Meier analysis demonstrated that the oncologic outcomes of RNU treated high-risk UTUC patients were improved much significantly by ACT, including PFS [P = 0.0033, HR = 3.78 (3.13-4.55)], OS [P = 0.0397, HR = 1.39 (1.01-1.75)] and CSS [P = 0.0255, HR = 1.26 (1.07-1.45)]. Further analysis of the lymph node positive subgroup showed that the median time of oncologic events was enhanced in RNU + ACT treated individuals in comparison with the RNU group, including PFS (11.4 months vs. 31.9 months, P = 0.0018), OS (26.8 months vs. 36.3 months, P = 0.0255) and CSS (28.2 months vs. 39.3 months, P = 0.0197). In the T3/4 cohort, significantly increased median PFS (13.9 months vs. 36.3 months, P = 0.0217), OS (20.6 months vs. 32.2 months, P = 0.0183) and CSS (21.9 months vs. 38.4 months, P = 0.0226) were obtained in the combination group. Additionally, no severe adverse events (over grade 4) associated with chemotherapy were detected in the RNU + ACT group. In conclusion, ACT after radical surgery has statistically significant therapeutic effects on PFS, OS and CSS in high-risk UTUC patients with cardiovascular comorbidity.",2020,"In the T3/4 cohort, significantly increased median PFS (13.9 months vs. 36.3 months, P = 0.0217), OS (20.6 months vs. 32.2 months, P = 0.0183) and CSS (21.9 months vs. 38.4 months, P = 0.0226) were obtained in the combination group.","['eligible patients treated in our hospital from January 2014 to March 2018 were included, and cases with late disease, renal dysfunction, severe cardiopulmonary disease or other malignant tumors were excluded', 'high-risk upper tract urothelial carcinoma patients with cardiovascular comorbidity', '176 high-risk UTUC individuals with cardiovascular comorbidity', 'high-risk UTUC patients with cardiovascular comorbidity', 'high risk upper tract urothelial carcinoma (UTUC) patients with cardiovascular comorbidity']","['radical nephroureterectomy and adjuvant chemotherapy (ACT', 'Adjuvant chemotherapy', 'radical nephroureterectomy']","['median time of oncologic events', 'survival outcome', 'BMI and lymphovacular invasion', 'progression free survival (PFS), overall survival (OS) and cancer specific survival (CSS', 'severe adverse events', 'OS', 'PFS', 'CSS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034072', 'cui_str': 'Cor pulmonale'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0027732', 'cui_str': 'Nephroureterectomy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",176.0,0.0418238,"In the T3/4 cohort, significantly increased median PFS (13.9 months vs. 36.3 months, P = 0.0217), OS (20.6 months vs. 32.2 months, P = 0.0183) and CSS (21.9 months vs. 38.4 months, P = 0.0226) were obtained in the combination group.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China. luoyonganzhen@163.com.""}, {'ForeName': 'Bingfu', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China.""}, {'ForeName': 'Dechao', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China.""}, {'ForeName': 'Yili', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China.""}, {'ForeName': 'Mingchuan', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China.""}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China.""}, {'ForeName': 'Yunhua', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China.""}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Hou', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China.""}, {'ForeName': 'Yongguang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Anzhenli Street, Chaoyang District, Beijing, 100029, People's Republic of China.""}]",Scientific reports,['10.1038/s41598-020-74940-x']
1250,33079152,Effect of Vericiguat vs Placebo on Quality of Life in Patients With Heart Failure and Preserved Ejection Fraction: The VITALITY-HFpEF Randomized Clinical Trial.,"Importance
Patients with heart failure and preserved ejection fraction (HFpEF) are at high risk of mortality, hospitalizations, and reduced functional capacity and quality of life.
Objective
To assess the efficacy of the oral soluble guanylate cyclase stimulator vericiguat on the physical limitation score (PLS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Design, Setting, and Participants
Phase 2b randomized, double-blind, placebo-controlled, multicenter trial of 789 patients with chronic HFpEF and left ventricular ejection fraction 45% or higher with New York Heart Association class II-III symptoms, within 6 months of a recent decompensation (HF hospitalization or intravenous diuretics for HF without hospitalization), and with elevated natriuretic peptides, enrolled at 167 sites in 21 countries from June 15, 2018, through March 27, 2019; follow-up was completed on November 4, 2019.
Interventions
Patients were randomized to receive vericiguat, up-titrated to 15-mg (n = 264) or 10-mg (n = 263) daily oral dosages, compared with placebo (n = 262) and randomized 1:1:1.
Main Outcomes and Measures
The primary outcome was change in the KCCQ PLS (range, 0-100; higher values indicate better functioning) after 24 weeks of treatment. The secondary outcome was 6-minute walking distance from baseline to 24 weeks.
Results
Among 789 randomized patients, the mean age was 72.7 (SD, 9.4) years; 385 (49%) were female; mean EF was 56%; and median N-terminal pro-brain natriuretic peptide level was 1403 pg/mL; 761 (96.5%) completed the trial. The baseline and 24-week KCCQ PLS means for the 15-mg/d vericiguat, 10-mg/d vericiguat, and placebo groups were 60.0 and 68.3, 57.3 and 69.0, and 59.0 and 67.1, respectively, and the least-squares mean changes were 5.5, 6.4, and 6.9, respectively. The least-squares mean difference in scores between the 15-mg/d vericiguat and placebo groups was -1.5 (95% CI, -5.5 to 2.5; P = .47) and between the 10-mg/d vericiguat and placebo groups was -0.5 (95% CI, -4.6 to 3.5; P = .80). The baseline and 24-week 6-minute walking distance mean scores in the 15-mg/d vericiguat, 10-mg/d vericiguat, and placebo groups were 295.0 m and 311.8m , 292.1 m and 318.3 m, and 295.8 m and 311.4 m, and the least-squares mean changes were 5.0 m, 8.7 m, and 10.5 m, respectively. The least-squares mean difference between the 15-mg/d vericiguat and placebo groups was -5.5 m (95% CI, -19.7 m to 8.8 m; P = .45) and between the 10-mg/d vericiguat and placebo groups was -1.8 m (95% CI, -16.2 m to 12.6 m; P = .81), respectively. The proportions of patients who experienced symptomatic hypotension were 6.4% in the 15-mg/d vericiguat group, 4.2% in the 10-mg/d vericiguat group, and 3.4% in the placebo group; those with syncope were 1.5%, 0.8%, and 0.4%, respectively.
Conclusions and Relevance
Among patients with HFpEF and recent decompensation, 24-week treatment with vericiguat at either 15-mg/d or 10-mg/d dosages compared with placebo did not improve the physical limitation score of the KCCQ.
Trial Registration
ClinicalTrials.gov Identifier: NCT03547583.",2020,"The baseline and 24-week 6-minute walking distance mean scores in the 15-mg/d vericiguat, 10-mg/d vericiguat, and placebo groups were 295.0 m and 311.8m , 292.1 m and 318.3 m, and 295.8 m and 311.4 m, and the least-squares mean changes were 5.0 m, 8.7 m, and 10.5 m, respectively.","['patients with HFpEF and recent decompensation', 'Importance\n\n\nPatients with heart failure and preserved ejection fraction (HFpEF', '789 randomized patients', 'Patients With Heart Failure and Preserved Ejection Fraction', 'mean age was 72.7 (SD, 9.4) years; 385 (49%) were female; mean EF was 56%; and median N-terminal pro-brain natriuretic peptide level was 1403 pg/mL; 761 (96.5%) completed the trial', '789 patients with chronic HFpEF and left ventricular ejection fraction 45% or higher with New York Heart Association class II-III symptoms, within 6 months of a recent decompensation (HF hospitalization or intravenous diuretics for HF without hospitalization), and with elevated natriuretic peptides, enrolled at 167 sites in 21 countries from June 15, 2018, through March 27, 2019; follow-up was completed on November 4, 2019']","['vericiguat, up-titrated to 15-mg (n\u2009=\u2009264) or 10-mg (n\u2009=\u2009263) daily oral dosages, compared with placebo', 'placebo', 'oral soluble guanylate cyclase stimulator vericiguat', 'Vericiguat vs Placebo']","['physical limitation score', 'Quality of Life', '6-minute walking distance mean scores', 'KCCQ PLS', 'symptomatic hypotension', '6-minute walking distance', 'physical limitation score (PLS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1533071', 'cui_str': 'N terminal pro-brain natriuretic peptide level'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C4517907', 'cui_str': '96.5'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1097411', 'cui_str': 'Nitric Oxide Receptors'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",789.0,0.376166,"The baseline and 24-week 6-minute walking distance mean scores in the 15-mg/d vericiguat, 10-mg/d vericiguat, and placebo groups were 295.0 m and 311.8m , 292.1 m and 318.3 m, and 295.8 m and 311.4 m, and the least-squares mean changes were 5.0 m, 8.7 m, and 10.5 m, respectively.","[{'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Division of Cardiology, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre of Singapore, Duke-National University of Singapore, Singapore.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ezekowitz', 'Affiliation': 'Division of Cardiology, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Charité University Medicine and German Heart Center, Berlin, Germany.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Lilin', 'Initials': 'L', 'LastName': 'She', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Vanja', 'Initials': 'V', 'LastName': 'Vlajnic', 'Affiliation': 'Bayer US, Whippany, New Jersey.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Carvalho', 'Affiliation': 'Bayer SA-Brazil, São Paulo, Brazil.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Bamber', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Blaustein', 'Affiliation': 'Merck & Co Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'University of Mississippi Medical Center, Jackson.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.15922']
1251,33079154,Effect of Praliciguat on Peak Rate of Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction: The CAPACITY HFpEF Randomized Clinical Trial.,"Importance
Heart failure with preserved ejection fraction (HFpEF) is often characterized by nitric oxide deficiency.
Objective
To evaluate the efficacy and adverse effects of praliciguat, an oral soluble guanylate cyclase stimulator, in patients with HFpEF.
Design, Setting, and Participants
CAPACITY HFpEF was a randomized, double-blind, placebo-controlled, phase 2 trial. Fifty-nine sites enrolled 196 patients with heart failure and an ejection fraction of at least 40%, impaired peak rate of oxygen consumption (peak V̇o2), and at least 2 conditions associated with nitric oxide deficiency (diabetes, hypertension, obesity, or advanced age). The trial randomized patients to 1 of 3 praliciguat dose groups or a placebo group, but was refocused early to a comparison of the 40-mg praliciguat dose vs placebo. Participants were enrolled from November 15, 2017, to April 30, 2019, with final follow-up on August 19, 2019.
Interventions
Patients were randomized to receive 12 weeks of treatment with 40 mg of praliciguat daily (n = 91) or placebo (n = 90).
Main Outcomes and Measures
The primary efficacy end point was the change from baseline in peak V̇o2 in patients who completed at least 8 weeks of assigned dosing. Secondary end points included the change from baseline in 6-minute walk test distance and in ventilatory efficiency (ventilation/carbon dioxide production slope). The primary adverse event end point was the incidence of treatment-emergent adverse events (TEAEs).
Results
Among 181 patients (mean [SD] age, 70 [9] years; 75 [41%] women), 155 (86%) completed the trial. In the placebo (n = 78) and praliciguat (n = 65) groups, changes in peak V̇o2 were 0.04 mL/kg/min (95% CI, -0.49 to 0.56) and -0.26 mL/kg/min (95% CI, -0.83 to 0.31), respectively; the placebo-adjusted least-squares between-group difference in mean change from baseline was -0.30 mL/kg/min ([95% CI, -0.95 to 0.35]; P = .37). None of the 3 prespecified secondary end points were statistically significant. In the placebo and praliciguat groups, changes in 6-minute walk test distance were 58.1 m (95% CI, 26.1-90.1) and 41.4 m (95% CI, 8.2-74.5), respectively; the placebo-adjusted least-squares between-group difference in mean change from baseline was -16.7 m (95% CI, -47.4 to 13.9). In the placebo and praliciguat groups, the placebo-adjusted least-squares between-group difference in mean change in ventilation/carbon dioxide production slope was -0.3 (95% CI, -1.6 to 1.0). There were more dizziness (9.9% vs 1.1%), hypotension (8.8% vs 0%), and headache (11% vs 6.7%) TEAEs with praliciguat compared with placebo. The frequency of serious TEAEs was similar between the groups (10% in the praliciguat group and 11% in the placebo group).
Conclusions and Relevance
Among patients with HFpEF, the soluble guanylate cyclase stimulator praliciguat, compared with placebo, did not significantly improve peak V̇o2 from baseline to week 12. These findings do not support the use of praliciguat in patients with HFpEF.
Trial Registration
ClinicalTrials.gov Identifier: NCT03254485.",2020,"In the placebo and praliciguat groups, changes in 6-minute walk test distance were 58.1 m (95% CI, 26.1-90.1) and 41.4 m (95% CI, 8.2-74.5), respectively; the placebo-adjusted least-squares between-group difference in mean change from baseline was -16.7 m (95% CI, -47.4 to 13.9).","['Patients With Heart Failure With Preserved Ejection Fraction', 'Fifty-nine sites enrolled 196 patients with heart failure and an ejection fraction of at least 40%, impaired peak rate of oxygen consumption (peak V̇o2), and at least 2 conditions associated with nitric oxide deficiency (diabetes, hypertension, obesity, or advanced age', '70 [9] years; 75 [41%] women), 155 (86%) completed the trial', 'Participants were enrolled from November 15, 2017, to April 30, 2019, with final follow-up on August 19, 2019', 'patients with HFpEF', '181 patients (mean [SD] age']","['preserved ejection fraction (HFpEF', '40-mg praliciguat dose vs placebo', 'HFpEF', 'placebo', 'Praliciguat']","['headache', 'hypotension', '6-minute walk test distance', '6-minute walk test distance and in ventilatory efficiency (ventilation/carbon dioxide production slope', 'dizziness', 'mean change in ventilation/carbon dioxide production slope', 'incidence of treatment-emergent adverse events (TEAEs', 'Peak Rate of Oxygen Consumption', 'frequency of serious TEAEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",196.0,0.757863,"In the placebo and praliciguat groups, changes in 6-minute walk test distance were 58.1 m (95% CI, 26.1-90.1) and 41.4 m (95% CI, 8.2-74.5), respectively; the placebo-adjusted least-squares between-group difference in mean change from baseline was -16.7 m (95% CI, -47.4 to 13.9).","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Udelson', 'Affiliation': 'Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina and the RHJ Department of Veterans Affairs Medical Center, Charleston.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Burnett', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Division of Cardiology, University Health Network, Mount Sinai Hospital, Toronto, Ontario.'}, {'ForeName': 'Jelena P', 'Initials': 'JP', 'LastName': 'Seferovic', 'Affiliation': 'Cyclerion Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Phebe', 'Initials': 'P', 'LastName': 'Wilson', 'Affiliation': 'Cyclerion Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mittleman', 'Affiliation': 'Ironwood Pharmaceuticals, Cambridge, Massachusetts.'}, {'ForeName': 'Albert T', 'Initials': 'AT', 'LastName': 'Profy', 'Affiliation': 'Cyclerion Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Marvin A', 'Initials': 'MA', 'LastName': 'Konstam', 'Affiliation': 'Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, Massachusetts.'}]",JAMA,['10.1001/jama.2020.16641']
1252,33087178,Efficacy of an online cognitive behavioral therapy program developed for healthcare workers during the COVID-19 pandemic: the REduction of STress (REST) study protocol for a randomized controlled trial.,"BACKGROUND
The acknowledgment of the mental health toll of the COVID-19 epidemic in healthcare workers has increased considerably as the disease evolved into a pandemic status. Indeed, high prevalence rates of depression, sleep disorders, and post-traumatic stress disorder (PTSD) have been reported in Chinese healthcare workers during the epidemic peak. Symptoms of psychological distress are expected to be long-lasting and have a systemic impact on healthcare systems, warranting the need for evidence-based psychological treatments aiming at relieving immediate stress and preventing the onset of psychological disorders in this population. In the current COVID-19 context, internet-based interventions have the potential to circumvent the pitfalls of face-to-face formats and provide the flexibility required to facilitate accessibility to healthcare workers. Online cognitive behavioral therapy (CBT) in particular has proved to be effective in treating and preventing a number of stress-related disorders in populations other than healthcare workers. The aim of our randomized controlled trial study protocol is to evaluate the efficacy of the 'My Health too' CBT program-a program we have developed for healthcare workers facing the pandemic-on immediate perceived stress and on the emergence of psychiatric disorders at 3- and 6-month follow-up compared to an active control group (i.e., bibliotherapy).
METHODS
Powered for superiority testing, this six-site open trial involves the random assignment of 120 healthcare workers with stress levels > 16 on the Perceived Stress Scale (PSS-10) to either the 7-session online CBT program or bibliotherapy. The primary outcome is the decrease of PSS-10 scores at 8 weeks. Secondary outcomes include depression, insomnia, and PTSD symptoms; self-reported resilience and rumination; and credibility and satisfaction. Assessments are scheduled at pretreatment, mid-treatment (at 4 weeks), end of active treatment (at 8 weeks), and at 3-month and 6-month follow-up.
DISCUSSION
This is the first study assessing the efficacy and the acceptability of a brief online CBT program specifically developed for healthcare workers. Given the potential short- and long-term consequences of the COVID-19 pandemic on healthcare workers' mental health, but also on healthcare systems, our findings can significantly impact clinical practice and management of the ongoing, and probably long-lasting, health crisis.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04362358 , registered on April 24, 2020.",2020,"Given the potential short- and long-term consequences of the COVID-19 pandemic on healthcare workers' mental health, but also on healthcare systems, our findings can significantly impact clinical practice and management of the ongoing, and probably long-lasting, health crisis.
","['healthcare workers during the COVID-19 pandemic', 'healthcare workers', '120 healthcare workers with stress levels >\u200916 on the Perceived Stress Scale (PSS-10) to either the']","['Online cognitive behavioral therapy (CBT', 'online CBT program', '7-session online CBT program or bibliotherapy', 'online cognitive behavioral therapy program']","['depression, insomnia, and PTSD symptoms; self-reported resilience and rumination; and credibility and satisfaction', 'decrease of PSS-10 scores']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0005365', 'cui_str': 'Bibliotherapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0580722,"Given the potential short- and long-term consequences of the COVID-19 pandemic on healthcare workers' mental health, but also on healthcare systems, our findings can significantly impact clinical practice and management of the ongoing, and probably long-lasting, health crisis.
","[{'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Weiner', 'Affiliation': ""Pôle de Psychiatrie, Santé Mentale et Addictologie, Hôpitaux Universitaires de Strasbourg, 1 place de l'hôpital, 67000, Strasbourg, France. weiner.l@gmail.com.""}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Berna', 'Affiliation': ""Pôle de Psychiatrie, Santé Mentale et Addictologie, Hôpitaux Universitaires de Strasbourg, 1 place de l'hôpital, 67000, Strasbourg, France.""}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Nourry', 'Affiliation': 'Faculté de Médecine, Université de Strasbourg, Strasbourg, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Severac', 'Affiliation': 'Département de Santé Publique, GMRC, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Vidailhet', 'Affiliation': ""Pôle de Psychiatrie, Santé Mentale et Addictologie, Hôpitaux Universitaires de Strasbourg, 1 place de l'hôpital, 67000, Strasbourg, France.""}, {'ForeName': 'Amaury C', 'Initials': 'AC', 'LastName': 'Mengin', 'Affiliation': ""Pôle de Psychiatrie, Santé Mentale et Addictologie, Hôpitaux Universitaires de Strasbourg, 1 place de l'hôpital, 67000, Strasbourg, France.""}]",Trials,['10.1186/s13063-020-04772-7']
1253,33087584,Music Can Reduce the Need for Pharmacologic Conscious Sedation During Invasive Coronary Angiography.,"OBJECTIVES
Opiates and benzodiazepines are commonly used during invasive coronary angiography (ICA) to address pain and anxiety. In the United States (US), these medications are used in more than 90% of such cases. The utility of these medications during ICA has not been addressed by the scientific societies. The goals of this study were to evaluate the impact of music on the use of opiates and benzodiazepines and levels of pain and anxiety in patients undergoing ICA.
METHODS
In this prospective pilot study, a total of 72 subjects undergoing elective ICA were randomized to receive planned pharmacologic standard conscious sedation (SCS), including opiates and/or benzodiazepines pre-ICA vs music plus opiates and/or benzodiazepines as needed. Pain and anxiety levels, as well as use of SCS medications, were monitored during the periprocedural period.
RESULTS
Baseline characteristics, including rates of anxiety, depression, and other psychiatric disorders, were similar between the SCS and music groups. The levels of pain and anxiety were relatively low and similar between the two cohorts during the peri-ICA period. There was a trend toward less frequent use of SCS medications in the music group (62.2% in the SCS group vs 40.0% in the music group; P=.06) and significantly less use of midazolam per case in the music group (0.68 mg in the SCS group vs 0.37 mg in the music group; P=.048). SCS medication use also differed significantly between the two operators.
CONCLUSIONS
Listening to patient-selected music during the peri-ICA period may reduce the need for pharmacologic conscious sedation without adversely affecting pain and anxiety levels.",2020,There was a trend toward less frequent use of SCS medications in the music group (62.2% in the SCS group vs 40.0% in the music group; P=.06) and significantly less use of midazolam per case in the music group (0.68 mg in the SCS group vs 0.37 mg in the music group; P=.048).,"['72 subjects undergoing elective ICA', 'patients undergoing ICA']","['benzodiazepines', 'planned pharmacologic standard conscious sedation (SCS), including opiates and/or benzodiazepines pre-ICA vs music plus opiates and/or benzodiazepines', 'invasive coronary angiography (ICA', 'SCS', 'midazolam']","['pain and anxiety', 'pain and anxiety levels', 'Pain and anxiety levels', 'SCS medications', 'rates of anxiety, depression, and other psychiatric disorders', 'Pharmacologic Conscious Sedation', 'levels of pain and anxiety']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",72.0,0.0630958,There was a trend toward less frequent use of SCS medications in the music group (62.2% in the SCS group vs 40.0% in the music group; P=.06) and significantly less use of midazolam per case in the music group (0.68 mg in the SCS group vs 0.37 mg in the music group; P=.048).,"[{'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Ebrahimi', 'Affiliation': 'Veterans Affairs Greater Los Angeles Healthcare System, 11301 Wilshire Blvd, mail code 111E, Los Angeles, CA 90073 USA. Ebrahimi@ucla.edu.'}, {'ForeName': 'A Laurie', 'Initials': 'AL', 'LastName': 'Shroyer', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dennis', 'Affiliation': ''}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Currier', 'Affiliation': ''}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Lendvai Wischik', 'Affiliation': ''}]",The Journal of invasive cardiology,[]
1254,32682770,A Randomized Trial of Initiation of Chronic Noninvasive Mechanical Ventilation at Home vs In-Hospital in Patients With Neuromuscular Disease and Thoracic Cage Disorder: The Dutch Homerun Trial.,"BACKGROUND
There is an increasing demand for home mechanical ventilation (HMV) in patients with chronic respiratory insufficiency. At present, noninvasive ventilation is exclusively initiated in a clinical setting at all four centers for HMV in the Netherlands. In addition to its high societal costs and patient discomfort, commencing HMV is often delayed because of a lack of hospital bed capacity.
RESEARCH QUESTION
Is HMV initiation at home, using a telemonitoring approach, noninferior to in-hospital initiation in a nationwide study?
STUDY DESIGN AND METHODS
We conducted a nationwide, randomized controlled noninferiority trial, in which every HMV center recruited 24 patients (home [n = 12] vs hospital [n = 12]) with a neuromuscular disease or thoracic cage disorder, all with an indication to start HMV. Change in arterial CO 2 (Paco 2 ) over a 6-month period was considered the primary outcome, and quality of life and costs were assessed as secondary outcomes.
RESULTS
A total of 96 patients were randomized, most of them diagnosed with neuromuscular disease. We found a significant improvement in Paco 2 within both groups (home: from 6.1 to 5.6 kPa [P < .01]; hospital: from 6.3 to 5.6 kPa [P < .01]), with no significant differences between groups. Health-related quality of life showed significant improvement on various subscales; however, no significant differences were observed between the home and hospital groups. From a societal perspective, a cost reduction of more than €3,200 ($3,793) per patient was evident in the home group.
INTERPRETATION
This nationwide, multicenter study shows that HMV initiation at home is noninferior to hospital initiation, as it shows the same improvement in gas exchange and health-related quality of life. In fact, from a patient's perspective, it might even be a more attractive approach. In addition, starting at home saves over €3,200 ($3,793) per patient over a 6-month period.
TRIAL REGISTRY
ClinicalTrials.gov; No.: NCT03203577; URL: www.clinicaltrials.gov.",2020,"Health-Related Quality of life (HRQoL) showed significant improvement on various subscales; however, no significant differences were observed between the home and hospital groups.","['patients with Neuromuscular Disease and thoracic cage disorder', '96 patients', 'patients with chronic respiratory insufficiency', '24 patients (home (n=12) vs hospital (n=12)) with a neuromuscular disease (NMD) or thoracic cage disorder, all with an indication to start HMV']","['chronic non-invasive mechanical ventilation', 'Home Mechanical Ventilation (HMV']","['PaCO₂', 'quality of life and costs', 'Change of arterial carbon dioxide (PaCO₂', 'Health-Related Quality of life (HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027868', 'cui_str': 'Myoneural disorder'}, {'cui': 'C0222762', 'cui_str': 'Thoracic cage structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1998122', 'cui_str': 'Chronic respiratory insufficiency'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",96.0,0.19593,"Health-Related Quality of life (HRQoL) showed significant improvement on various subscales; however, no significant differences were observed between the home and hospital groups.","[{'ForeName': 'Ries J M', 'Initials': 'RJM', 'LastName': 'van den Biggelaar', 'Affiliation': 'Department of Pulmonary Diseases/Department of Intensive Care Medicine and Home Mechanical Ventilation, Erasmus Medical Center Rotterdam, The Netherlands. Electronic address: r.vandenbiggelaar@erasmusmc.nl.'}, {'ForeName': 'Anda', 'Initials': 'A', 'LastName': 'Hazenberg', 'Affiliation': 'Department of Pulmonary Diseases/Home Mechanical Ventilation, University of Groningen, University Medical Center Groningen, the Netherlands; Groningen Research Institute for Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Nicolle A M', 'Initials': 'NAM', 'LastName': 'Cobben', 'Affiliation': 'Department of Pulmonary Diseases/Home Mechanical Ventilation, University Medical Center Maastricht, the Netherlands.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gaytant', 'Affiliation': 'Department of Pulmonary Diseases/Home Mechanical Ventilation, University Medical Center Utrecht, the Netherlands.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Wijkstra', 'Affiliation': 'Department of Pulmonary Diseases/Home Mechanical Ventilation, University of Groningen, University Medical Center Groningen, the Netherlands; Groningen Research Institute for Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, the Netherlands.'}]",Chest,['10.1016/j.chest.2020.07.007']
1255,33066103,Transcutaneous Spinal Cord Stimulation Enhances Quadriceps Motor Evoked Potential in Healthy Participants: A Double-Blind Randomized Controlled Study.,"Transcutaneous electrical spinal cord stimulation (tSCS) is a non-invasive technique for neuromodulation and has therapeutic potential for motor rehabilitation following spinal cord injury. The main aim of the present study is to quantify the effect of a single session of tSCS on lower limb motor evoked potentials (MEPs) in healthy participants. A double-blind, sham-controlled, randomized, crossover, clinical trial was carried out in 15 participants. Two 10-min sessions of tSCS (active-tSCS and sham-tSCS) were applied at the T11-T12 vertebral level. Quadriceps (Q) and tibialis anterior (TA) muscle MEPs were recorded at baseline, during and after tSCS. Q and TA isometric maximal voluntary contraction was also recorded. A significant increase of the Q-MEP amplitude was observed during active-tSCS (1.96 ± 0.3 mV) when compared from baseline (1.40 ± 0.2 mV; p = 0.01) and when compared to sham-tSCS at the same time-point (1.13 ± 0.3 mV; p = 0.03). No significant modulation was identified for TA-MEP amplitude or for Q and TA isometric maximal voluntary isometric strength. In conclusion, tSCS applied over the T11-T12 vertebral level increased Q-MEP but not TA-MEP compared to sham stimulation. The specific neuromodulatory effect of tSCS on Q-MEP may reflect optimal excitation of this motor response at the interneuronal or motoneuronal level.",2020,No significant modulation was identified for TA-MEP amplitude or for Q and TA isometric maximal voluntary isometric strength.,"['15 participants', 'healthy participants', 'Healthy Participants']","['tSCS', 'Transcutaneous Spinal Cord Stimulation', 'tSCS (active-tSCS and sham-tSCS', 'Transcutaneous electrical spinal cord stimulation (tSCS']","['TA-MEP amplitude or for Q and TA isometric maximal voluntary isometric strength', 'Q-MEP amplitude', 'lower limb motor evoked potentials (MEPs', 'T11-T12 vertebral level increased Q-MEP', 'Q and TA isometric maximal voluntary contraction', 'Quadriceps (Q) and tibialis anterior (TA) muscle MEPs']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0054967', 'cui_str': 'Lymphocyte antigen CD6'}, {'cui': 'C0446409', 'cui_str': 'Vertebral level'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",15.0,0.247662,No significant modulation was identified for TA-MEP amplitude or for Q and TA isometric maximal voluntary isometric strength.,"[{'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Megía-García', 'Affiliation': 'Biomechanical and Technical Aids Unit, National Hospital for Paraplegia, SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Serrano-Muñoz', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha University, 45071 Toledo, Spain.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Sensorimotor Function Group, National Hospital for Paraplegia, SESCAM, 45071 Toledo, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Avendaño-Coy', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha University, 45071 Toledo, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Comino-Suárez', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha University, 45071 Toledo, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Gómez-Soriano', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha University, 45071 Toledo, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9103275']
1256,33069063,Reliability of ultrasound measurement for isolated control of the transversus abdominis muscle during abdominal hollowing: A secondary analysis.,"Ultrasonography (US) measurements of the transversus abdominis muscle (TrA) during abdominal hollowing (AH) are conducted at the maximum AH, which would be unable to evaluate isolated control of the TrA to the internal or external oblique muscles (outer muscles). The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US. The datasets of two follow-ups were analyzed with 1-week interval of a wait-and-see control group comprising 20 participants with LBP in a randomized controlled trial. The primary measures were; % change in the thickness of the TrA at 1 cm lateral to the muscle-fascia junction of the TrA, and changes in horizontal distance of the superior edge of the TrA fascia. The measurement time points were immediately before AH during resting and when outer muscle thickness above 1 cm lateral to the muscle-fascia junction of the TrA increased by 10%. Consequently, five repetitions were required to obtain a stable mean value and good reliability (intraclass correlation coefficient [ICC] (1,5) = 0.65-0.68 for the % change, and 0.84-0.88 for the change in horizontal distance; ICC (2,5) = 0.82 for the % change, and 0.93 for the change in horizontal distance).",2020,The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US.,[],"['ICC', 'Ultrasonography (US) measurements of the transversus abdominis muscle (TrA) during abdominal hollowing (AH']","['thickness of the TrA at 1\xa0cm lateral to the muscle-fascia junction of the TrA, and changes in horizontal distance of the superior edge of the TrA fascia']",[],"[{'cui': 'C0242349', 'cui_str': 'Immunocytochemical procedure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}]",20.0,0.0294516,The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US.,"[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takasaki', 'Affiliation': 'Department of Physical Therapy, Saitama Prefectural University, Koshigaya, Saitama, Japan. Electronic address: physical.therapy.takasaki@gmail.com.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Kawazoe', 'Affiliation': 'Department of Physical Therapy, Saitama Prefectural University, Koshigaya, Saitama, Japan.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2020.102476']
1257,33069106,Brief mindfulness training for smoking cessation in Chinese women in workplaces: A pilot randomized controlled trial.,"INTRODUCTION
Mindfulness training (MT) has shown preliminary efficacy as a behavioral treatment for smoking cessation. We examined the effect of a brief-MT intervention on smoking cessation for Chinese women in workplaces in Hong Kong, China.
METHODS
In this pilot randomized controlled trial, 213 daily smokers were recruited from workplaces and computer-randomized into the intervention (n = 114) or control (n = 99) groups. Participants in both groups received a self-help booklet. Participants in the intervention group additionally attended 2 sessions of a brief-MT workshop. The primary outcome was self-reported 7-day point-prevalence abstinence (PPA) at 6 months. Secondary outcomes were biochemically validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/mL) and smoking reduction at 6 months. Analyses were done by intention to treat. We conducted a post-trial qualitative evaluation on participants in the intervention group (n = 14). Data were analyzed thematically.
RESULTS
At 6-month follow-up, self-reported 7-day PPA were similar between the intervention and control groups (18.4% vs. 21.2%; P = 0.61). Very few participated in biochemical validation (n = 17), and validated abstinence and smoking reduction rates showed no significant difference (5.3% vs. 11.1%, P = 0.12 and 20.2% vs. 20.2%, P = 1.00, respectively). A posteriori analysis showed that brief-MT participants who were psychologically engaged with the intervention had greater 6-month PPA. Qualitative evaluation showed brief-MT reduced stress but its effectiveness was restrained by the insufficient home practice.
CONCLUSIONS
This pilot trial on a brief-MT intervention for smoking cessation on Chinese women in workplaces showed feasibility, but improving compliance is needed to maximize the efficacy in future fully powered trials.",2020,"At 6-month follow-up, self-reported 7-day PPA were similar between the intervention and control groups (18.4% vs. 21.2%; P = 0.61).","['Chinese women in workplaces', 'participants in the intervention group (n\xa0=\xa014', 'Chinese women in workplaces in Hong Kong, China', '213 daily smokers were recruited from workplaces and computer-randomized into the intervention (n\xa0=\xa0114) or control (n\xa0=\xa099) groups']","['self-help booklet', 'Mindfulness training (MT', 'MT intervention', 'brief-MT intervention', 'Brief mindfulness training']","['validated abstinence and smoking reduction rates', 'smoking reduction', '6-month PPA', 'smoking cessation', '7-day PPA', 'self-reported 7-day point-prevalence abstinence (PPA', 'salivary cotinine']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}]",213.0,0.102459,"At 6-month follow-up, self-reported 7-day PPA were similar between the intervention and control groups (18.4% vs. 21.2%; P = 0.61).","[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Tzu Tsun', 'Initials': 'TT', 'LastName': 'Luk', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Oi Sze', 'Initials': 'OS', 'LastName': 'Lau', 'Affiliation': 'The Lok Sin Tong Benevolent Society Kowloon, Hong Kong SAR, China.'}, {'ForeName': 'Yi Nam', 'Initials': 'YN', 'LastName': 'Suen', 'Affiliation': 'Department of Psychiatry, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Jung Jae', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'William Ho-Cheung', 'Initials': 'WH', 'LastName': 'Li', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Jojo Yan Yan', 'Initials': 'JYY', 'LastName': 'Kwok', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China. Electronic address: mpwang@hku.hk.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106677']
1258,33069109,Behavioral modification decreases approach bias in young adults with internet gaming disorder.,"BACKGROUND
One of the key symptoms of Internet gaming disorder is the impulsive pursuit of Internet games, which causes individuals with this disorder to have a tendency to approach gaming cues. Dual processing theory states that this approach bias is caused by the suppression of reflective processing and the hyperactivity of impulsive processing. Therefore, reverse modification training for approach bias can suppress impulsive processing, thereby reducing or treating the disorder.
METHOD
In this study, 48 individuals with Internet gaming disorder were selected and randomly assigned to the following two groups: the experimental group and the control group. The 24 participants in the experimental group received a 4-day stimulus-response compatibility (SRC) approach bias modification treatment, whereas the 24 participants in the control group received a corresponding SRC pseudomodification training.
RESULTS
The approach response time of both groups to the gaming cues was significantly shorter than that to the neutral cues at baseline. After the modification, the response time of the experimental group to the gaming cues significantly increased, whereas the scores for Internet gaming disorder severity, anxiety level and craving significantly decreased. However, the control group subjects did not show these effects.
CONCLUSION
The current results imply that individuals with Internet gaming disorder show approach bias toward Internet gaming cues, and SRC reverse modification training can significantly correct this bias and therefore have therapeutic effects to some extent.",2020,"After the modification, the response time of the experimental group to the gaming cues significantly increased, whereas the scores for Internet gaming disorder severity, anxiety level and craving significantly decreased.","['young adults with internet gaming disorder', 'individuals with Internet gaming disorder', '48 individuals with Internet gaming disorder']","['4-day stimulus-response compatibility (SRC) approach bias modification treatment', 'corresponding SRC pseudomodification training', 'Behavioral modification']","['scores for Internet gaming disorder severity, anxiety level and craving', 'response time', 'gaming cues']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4760905', 'cui_str': 'Internet gaming disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4760905', 'cui_str': 'Internet gaming disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",48.0,0.0253849,"After the modification, the response time of the experimental group to the gaming cues significantly increased, whereas the scores for Internet gaming disorder severity, anxiety level and craving significantly decreased.","[{'ForeName': 'Jinbo', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China. Electronic address: hjb@mail.ccnu.edu.cn.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Pan', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Nie', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Suqing', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106686']
1259,33069121,Add-on memantine may improve cognitive functions and attenuate inflammation in middle- to old-aged bipolar II disorder patients.,"OBJECTIVES
Chronic inflammation and neuroprogression underlie bipolar disorder (BP) and associated cognitive deficits. Memantine (MM) exerts neuroprotective effects by reducing neuroinflammation. Therefore, we investigated whether add-on low-dose MM (5 mg/day) in BP-II patients may improve cognition and inflammation.
METHODS
We combined two 12-week randomized, double-blind, placebo-controlled studies (NCT01188148 and NCT03039842) for analysis. Each participant was allocated to the MM or placebo group. Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1 (TGF-β1), and brain-derived neurotrophic factor (BDNF)] were evaluated at baseline and endpoint. A subgroup analysis of middle- to old-aged BP-II patients was also performed.
RESULTS
We recruited 155 BP-II patients (23 of which were middle- to old-aged) for the MM group and 170 patients (20 of which were middle- to old-aged) for the placebo group. Add-on MM did not result in significant improvements in cognitive functions in all BP-II patients, but a group difference in TNF-α levels was found in the MM group (P=0.04). Specifically, in middle- to old-aged BP-II patients, there was a significant time and group interaction effect on omission T-scores, hit reaction time T-scores, and hit reaction time standard error T-scores on continuous performance tests (CPTs) in the MM group (P=0.007, 0.02, and 0.01, respectively), and a decrease in plasma TNF-α levels (P=0.04).
LIMITATIONS
The sample size of middle- to old-aged BP-II patients were limited.
CONCLUSION
Add-on MM may attenuate inflammation in BP-II and improve cognition in middle- to old-aged BP-II patients.",2020,"Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1","['155 BP-II patients (23 of which were middle- to old-aged) for the MM group and 170 patients (20 of which were middle- to old-aged) for the placebo group', 'sample size of middle- to old-aged BP-II patients were limited', 'middle- to old-aged bipolar II disorder patients']","['MM or placebo', 'placebo', 'Memantine (MM', 'memantine']","['TGF-β1), and brain-derived neurotrophic factor (BDNF', 'omission T-scores, hit reaction time T-scores, and hit reaction time standard error T-scores on continuous performance tests (CPTs', 'TNF-α levels', 'cognition and inflammation', 'cognitive functions', 'plasma TNF-α levels', 'Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1']","[{'cui': 'C0236788', 'cui_str': 'Bipolar II disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}]",,0.407349,"Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1","[{'ForeName': 'Ru-Band', 'Initials': 'RB', 'LastName': 'Lu', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Yanjiao Furen Hospital, Hebei, China.'}, {'ForeName': 'Tzu-Yun', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan. Electronic address: wangty@mail.ncku.edu.tw.'}, {'ForeName': 'Sheng-Yu', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Yun-Hsuan', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychology, Asia University, Taichung, Taiwan; Department of Medical Research, China Medical University Hospital, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Shiou-Lan', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Lipid Science and Aging Research Center, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Tsung-Yu', 'Initials': 'TY', 'LastName': 'Tsai', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Po See', 'Initials': 'PS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'San-Yuan', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Nian-Sheng', 'Initials': 'NS', 'LastName': 'Tzeng', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Student Counseling Center, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'I Hui', 'Initials': 'IH', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Kao Chin', 'Initials': 'KC', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yen Kuang', 'Initials': 'YK', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Psychiatry, Tainan Hospital, Ministry of Health and Welfare, Tainan, Taiwan.'}, {'ForeName': 'Jau-Shyong', 'Initials': 'JS', 'LastName': 'Hong', 'Affiliation': 'Neurobiology Laboratory, NIH/NIEHS, Research Triangle Park, NC, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.003']
1260,33074110,Breathing exercises and pranayamas to decrease perceived exertion during breath-holding while locked-down due to COVID-19 online randomized study.,"AIM
to compare anulom vilom pranayama (AVP), kapal bhati pranayama (KBP), diaphragmatic breathing exercises (DBE), and pursed-lip breathing (PLB) for breath holding time (BHT) and rating of perceived exertion (RPE). Methods- Participants were assessed for BHT and RPE, before training on any one intervention using online platforms, for one week during lockdown from COVID-19.15 participants in each group total N = 60 at- (α - 0.05), (1- β - 0.90) & (effect size - 0.55); were analysed. Results - AVP & DBE decreased RPE (p < 0.000). KBP & PLB did not decrease RPE as compared to AVP & DBE (p. > 0.05). DBE increased BHT more than KBP & PLB interventions (p < 0.05), but not more than AVP (p > 0.05). One-way ANOVA of four interventions revealed significant variation for RPE change (p < 0.05), for AVP. Conclusions - AVP reduces RPE maximally during breath-holding, whereas DPE increases BHT more.",2020,KBP & PLB did not decrease RPE as compared to AVP & DBE,['60\xa0at'],"['Breathing exercises and pranayamas to decrease perceived exertion during breath-holding while locked', 'AVP & DBE']","['RPE', 'anulom vilom pranayama (AVP), kapal bhati pranayama (KBP), diaphragmatic breathing exercises (DBE), and pursed-lip breathing (PLB) for breath holding time (BHT) and rating of perceived exertion (RPE', 'RPE change', 'DBE increased BHT']",[],"[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0454509', 'cui_str': 'Diaphragmatic breathing exercises'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0454509', 'cui_str': 'Diaphragmatic breathing exercises'}, {'cui': 'C0425465', 'cui_str': 'Pursed-lip breathing'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0686435,KBP & PLB did not decrease RPE as compared to AVP & DBE,"[{'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Shukla', 'Affiliation': 'AP-III, AIPT, 9711113097, India. Electronic address: mailmayankshukla@gmail.com.'}, {'ForeName': 'Diksha', 'Initials': 'D', 'LastName': 'Chauhan', 'Affiliation': 'BPT Interns, AIPT, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Raj', 'Affiliation': 'BPT Interns, AIPT, India.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101248']
1261,33074143,Ketamine Alters Electrophysiological Responses to Emotional Faces in Major Depressive Disorder.,"BACKGROUND
The glutamatergic modulator ketamine rapidly reduces depressive symptoms in individuals with treatment-resistant major depressive disorder (MDD). However, ketamine's effects on emotional processing biases remain largely unknown, and understanding these processes may help elucidate ketamine's mechanism of action.
METHODS
Magnetoencephalography (MEG) was used to investigate ketamine's effects on early visual responses to affective stimuli in individuals with MDD (n=31) and healthy volunteers (HVs; n=24). Participants were enrolled in a double-blind, placebo-controlled, crossover clinical trial and were assessed at baseline and after subanesthetic-dose ketamine and placebo-saline infusions. During MEG recording, participants completed an emotional evaluation task in which they indicated the sex or emotional valence (happy-neutral or sad-angry) of facial stimuli. Source-localized event-related field (ERF) M100 and M170 amplitudes and latencies were extracted from regions of interest. Linear fixed effects models examined interactions between diagnosis, stimulus valence, and drug session for behavioral and MEG data.
RESULTS
In baseline behavioral analyses, MDD participants exhibited higher accuracy for sad-angry than happy-neutral faces, and HVs responded faster to happy-neutral than sad-angry faces. In the MEG post-infusion analyses, calcarine M100 amplitudes were larger in MDD than HV participants post-placebo but became more similar post-ketamine. Finally, fusiform M170 amplitudes were associated with antidepressant response in MDD participants.
LIMITATIONS
The modest sample size and the need to collapse across responses to happy and neutral faces to increase statistical power limit the generalizability of the findings.
CONCLUSIONS
Ketamine rapidly altered emotional stimulus processing in MDD, laying the groundwork for future investigations of biomarkers of antidepressant treatment response.
CLINICAL TRIAL
Clinicaltrials.gov, NCT#00088699.",2020,"In the MEG post-infusion analyses, calcarine M100 amplitudes were larger in MDD than HV participants post-placebo but became more similar post-ketamine.","['individuals with MDD (n=31) and healthy volunteers (HVs; n=24', 'Major Depressive Disorder', 'individuals with treatment-resistant major depressive disorder (MDD']","[""ketamine's"", 'Ketamine', 'glutamatergic modulator ketamine', 'ketamine', 'Magnetoencephalography (MEG', 'ketamine and placebo-saline infusions', 'placebo']","['Source-localized event-related field (ERF) M100 and M170 amplitudes and latencies', 'sex or emotional valence (happy-neutral or sad-angry) of facial stimuli', 'depressive symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.464333,"In the MEG post-infusion analyses, calcarine M100 amplitudes were larger in MDD than HV participants post-placebo but became more similar post-ketamine.","[{'ForeName': 'Nancy B', 'Initials': 'NB', 'LastName': 'Lundin', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA;; Department of Psychological and Brain Sciences and Program in Neuroscience, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Sepe-Forrest', 'Affiliation': 'Department of Psychological and Brain Sciences and Program in Neuroscience, Indiana University, Bloomington, IN, USA;; Magnetoencephalography Core Facility, National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Gilbert', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Frederick W', 'Initials': 'FW', 'LastName': 'Carver', 'Affiliation': 'Magnetoencephalography Core Facility, National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Maura L', 'Initials': 'ML', 'LastName': 'Furey', 'Affiliation': 'Janssen Pharmaceuticals of Johnson and Johnson Inc., San Diego, CA, United States.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA;; Magnetoencephalography Core Facility, National Institute of Mental Health, Bethesda, MD, USA;. Electronic address: nugenta@mail.nih.gov.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.007']
1262,33070154,"The effects of inhibition of fatty acid amide hydrolase (FAAH) by JNJ-42165279 in social anxiety disorder: a double-blind, randomized, placebo-controlled proof-of-concept study.","JNJ-42165279 is a selective inhibitor of fatty acid amide hydrolase (FAAH), the enzyme responsible for the degradation of fatty acid amides (FAA) including anandamide (AEA), palmitoylethanolamide (PEA), and N-oleoylethanolamide (OEA). We assessed the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of treatment with JNJ-42165279 in subjects with social anxiety disorder (SAD). This was a multicenter, double-blind, placebo-controlled study randomizing subjects to 12 weeks of treatment with either JNJ-42165279 (25 mg daily) or placebo (PBO). The primary endpoint was the change in the Liebowitz Social Anxiety Scale (LSAS) total score from baseline to end of study. Secondary endpoints included the Hamilton Anxiety Scale (HAM-A), Hamilton Depression Rating Scale (HDRS 17 ), and the Clinical Global Impression-Improvement (CGI-I). Samples were collected for plasma concentration of AEA, PEA, OEA, and JNJ-42165279. A total of 149 subjects were enrolled with a mean baseline LSAS total score of 102.6 (SD 16.84). The mean change from baseline (SD) in LSAS total score at week 12 was numerically greater for JNJ-42165279: -29.4 (27.47) compared to PBO: -22.4 (23.57) but not significant. The percentage of subjects with ≥30% improvement from baseline in the LSAS total score was significantly higher for JNJ-42165279 (42.4%) compared to PBO (23.6%) (p value = 0.04). The percentage of subjects with a CGI-I score of much or very much improved was also significantly higher for JNJ-42165279 (44.1%) than for PBO (23.6%) (p value = 0.02). The drug was well tolerated. JNJ-42165279 appears to elicit an anxiolytic effect in subjects with SAD although trough concentrations with 25 mg once daily appeared to be insufficient to completely inhibit FAAH activity which may have led to suboptimal efficacy. ClinicalTrials.gov Identifier: NCT02432703.",2020,The percentage of subjects with ≥30% improvement from baseline in the LSAS total score was significantly higher for JNJ-42165279 (42.4%) compared to PBO (23.6%) (p value = 0.04).,"['A total of 149 subjects were enrolled with a mean baseline LSAS total score of 102.6 (SD 16.84', 'social anxiety disorder', 'subjects with social anxiety disorder (SAD', 'subjects with SAD']","['placebo', 'JNJ-42165279', 'fatty acid amide hydrolase (FAAH', 'placebo (PBO']","['Liebowitz Social Anxiety Scale (LSAS) total score', 'anxiolytic effect', 'efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics', 'tolerated', 'plasma concentration of AEA, PEA, OEA, and JNJ-42165279', 'LSAS total score', 'Hamilton Anxiety Scale (HAM-A), Hamilton Depression Rating Scale (HDRS 17 ), and the Clinical Global Impression-Improvement (CGI-I', 'mean change from baseline (SD) in LSAS total score']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C5139852', 'cui_str': 'JNJ-42165279'}, {'cui': 'C0531004', 'cui_str': 'fatty acid amide hydrolase'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3179404', 'cui_str': 'Anti-Anxiety Effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002482', 'cui_str': 'Amide'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0211726', 'cui_str': 'anandamide'}, {'cui': 'C0069964', 'cui_str': 'palmidrol'}, {'cui': 'C1454896', 'cui_str': 'oleoylethanolamide'}, {'cui': 'C5139852', 'cui_str': 'JNJ-42165279'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",149.0,0.0684413,The percentage of subjects with ≥30% improvement from baseline in the LSAS total score was significantly higher for JNJ-42165279 (42.4%) compared to PBO (23.6%) (p value = 0.04).,"[{'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Schmidt', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium. mschmid4@its.jnj.com.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Liebowitz', 'Affiliation': 'The Medical Research Network, New York, NY, USA.'}, {'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Stein', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Grunfeld', 'Affiliation': 'Peninsula Therapeutic & Research Group, Frankston, VIC, Australia.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Van Hove', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'W Kyle', 'Initials': 'WK', 'LastName': 'Simmons', 'Affiliation': 'Janssen Research & Development, La Jolla, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Der Ark', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Palmer', 'Affiliation': 'Janssen Research & Development, La Jolla, CA, USA.'}, {'ForeName': 'Ziad S', 'Initials': 'ZS', 'LastName': 'Saad', 'Affiliation': 'Janssen Research & Development, La Jolla, CA, USA.'}, {'ForeName': 'Darrel J', 'Initials': 'DJ', 'LastName': 'Pemberton', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Van Nueten', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Janssen Research & Development, La Jolla, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00888-1']
1263,33076411,Winter Exercise and Speleotherapy for Allergy and Asthma: A Randomized Controlled Clinical Trial.,"(1) Background: The prevalence of allergic respiratory diseases is still rising and efforts towards holistic treatments should be made. Although speleotherapy is widely applied in Europe to treat chronic airway diseases, the existing scientific evidence is rather low. Recreational winter exercise has been shown to improve allergic airway inflammation, but little is known about the combined effects of speleotherapy and recreational winter exercise. (2) Methods: In this clinical study we investigated the effects of winter exercise and speleotherapy on adults with allergic rhinitis and/or asthma. The speleotherapy group (n = 23) participated in a ten-day combined winter exercise and speleotherapy program and the exercise group (n = 18) joined a full-day winter sports program. The effects on allergic airway inflammation, quality of life, spirometry and cardiorespiratory fitness were assessed. (3) Results: No significant effects were found for fractional exhaled nitric oxide or nasal nitric oxide. Quality of life ( p < 0.001 time effect) and allergic symptoms ( p < 0.001 time effect) were improved in the speleotherapy and in the exercise group. (4) Conclusions: Winter exercise alone and winter exercise in combination with speleotherapy improve quality of life and allergic symptoms in adults with allergic rhinitis and/or asthma. Further studies are required to investigate the specific effects of speleotherapy. To our knowledge, this is the first investigation examining speleotherapy in combination with winter exercise. Recreational outdoor winter exercise and speleotherapy may be recommended for highly functioning patients with good disease control.",2020,Quality of life ( p < 0.001 time effect) and allergic symptoms ( p < 0.001 time effect) were improved in the speleotherapy and in the exercise group.,"['adults with allergic rhinitis and/or asthma', 'group (n = 23) participated in a ten', 'highly functioning patients with good disease control', 'Allergy and Asthma']","['Winter exercise alone and winter exercise in combination with speleotherapy', 'Winter Exercise and Speleotherapy', 'winter exercise and speleotherapy', 'Recreational outdoor winter exercise and speleotherapy', 'Recreational winter exercise', 'day combined winter exercise and speleotherapy program and the exercise group (n = 18) joined a full-day winter sports program', 'speleotherapy']","['fractional exhaled nitric oxide or nasal nitric oxide', 'allergic symptoms', 'Quality of life', 'allergic airway inflammation, quality of life, spirometry and cardiorespiratory fitness', 'quality of life and allergic symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0339510', 'cui_str': 'Vitelliform dystrophy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2350293', 'cui_str': 'Speleotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",23.0,0.0253318,Quality of life ( p < 0.001 time effect) and allergic symptoms ( p < 0.001 time effect) were improved in the speleotherapy and in the exercise group.,"[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Freidl', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Huber', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Braunschmid', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Romodow', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pichler', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Weisböck-Erdheim', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Mayr', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Hartl', 'Affiliation': 'Institute of Ecomedicine, Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}]",Journal of clinical medicine,['10.3390/jcm9103311']
1264,33078599,The post-progression survival of patients with recurrent or persistent ovarian clear cell carcinoma: results from a randomized phase III study in JGOG3017/GCIG.,"OBJECTIVE
In this study we sought to investigate the clinical factors that affect post-progression survival (PPS) in patients with recurrent or persistent clear cell carcinoma (CCC). We utilized the JGOG3017/Gynecological Cancer InterGroup data to compare paclitaxel plus carboplatin (TC) and irinotecan plus cisplatin (CPT-P) in the treatment of stages I to IV CCC.
METHODS
We enrolled 166 patients with recurrent or persistent CCC and assessed the impact of variables, including platinum sensitivity, treatment arm, crossover chemotherapy, primary stage, residual tumor at primary surgery, performance status, ethnicity, and tumor reduction surgery at recurrence on the median of PPS in patients with recurrent or persistent CCC.
RESULTS
A total of 77 patients received TC, and 89 patients received CPT-P. The median PPS for patients with platinum-resistant disease was 10.9 months, compared with 18.8 months for patients with platinum-sensitive disease (hazard ratio [HR]=1.88; 95% confidence interval [CI]=1.30-2.72; log-rank p<0.001). In the multivariate analysis, the platinum sensitivity (resistant vs. sensitivity; HR=1.60; p=0.027) and primary stage (p=0.009) were identified as independent predictors of prognosis factors for PPS in recurrent or persistent CCC.
CONCLUSIONS
Our findings revealed that platinum sensitivity and primary stage are clinical factors that significantly affect PPS in patients with recurrent or persistent CCC as well as other histologic subtypes of ovarian cancer. PPS in patients with recurrent CCC should establish the basis for future clinical trials in this population.",2020,"In the multivariate analysis, the platinum sensitivity (resistant vs. sensitivity; HR=1.60; p=0.027) and primary stage (p=0.009) were identified as independent predictors of prognosis factors for PPS in recurrent or persistent CCC.
","['patients with recurrent CCC', 'patients with recurrent or persistent clear cell carcinoma (CCC', '77 patients received TC, and 89 patients received', 'patients with recurrent or persistent CCC', '166 patients with recurrent or persistent CCC and assessed the impact of variables, including platinum sensitivity, treatment arm, crossover chemotherapy, primary stage, residual tumor at primary surgery, performance status, ethnicity, and tumor reduction surgery at recurrence on the median of PPS in patients with recurrent or persistent CCC', 'patients with recurrent or persistent ovarian clear cell carcinoma']","['paclitaxel plus carboplatin (TC) and irinotecan plus cisplatin (CPT-P', 'CPT-P', 'JGOG3017/GCIG']","['progression survival (PPS', 'median PPS', 'platinum sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0206681', 'cui_str': 'Clear cell adenocarcinoma'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3544205', 'cui_str': 'Ovarian clear cell carcinoma'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",166.0,0.0744463,"In the multivariate analysis, the platinum sensitivity (resistant vs. sensitivity; HR=1.60; p=0.027) and primary stage (p=0.009) were identified as independent predictors of prognosis factors for PPS in recurrent or persistent CCC.
","[{'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kondo', 'Affiliation': 'Department of Obstetrics and Gynecology, Mie University School of medicine, Tsu, Japan. eijikon@clin.medic.mie-u.ac.jp.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Tabata', 'Affiliation': ""Department of Obstetrics and Gynecology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': 'Department of Obstetrics and Gynecology, St. Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Aoki', 'Affiliation': 'Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Yahata', 'Affiliation': 'Department of Obstetrics and Gynecology, Kyushu University School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Kotera', 'Affiliation': 'Division of Clinical Research, Global Clinical Research Coordinating Center, Kitasato University, Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Tokuyama', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Obstetrics and Gynecology, Saitama Medical University International Medical Center, Hidaka, Japan.'}, {'ForeName': 'Eizo', 'Initials': 'E', 'LastName': 'Kimura', 'Affiliation': 'Department of Obstetrics and Gynecology, Kosei General Hospital, Kutchan, Japan.'}, {'ForeName': 'Fumitoshi', 'Initials': 'F', 'LastName': 'Terauchi', 'Affiliation': 'Department of Obstetrics and Gynecology, Tokyo Medical University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Sumi', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka City University School of Medicine, Osaka, Japan.'}, {'ForeName': 'Aikou', 'Initials': 'A', 'LastName': 'Okamoto', 'Affiliation': 'Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Yaegashi', 'Affiliation': 'Department of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Enomoto', 'Affiliation': 'Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, Morioka, Japan.'}]",Journal of gynecologic oncology,['10.3802/jgo.2020.31.e94']
1265,33078600,Olaparib and bevacizumab in front-line maintenance of ovarian cancer: an over reliance in unpowered subgroup analysis of the PAOLA-1 trial?,,2020,,['ovarian cancer'],['Olaparib and bevacizumab'],[],"[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]",[],,0.211095,,"[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Paulino', 'Affiliation': 'Brazilian National Cancer Institute and Grupo Oncoclínicas, Rio de Janeiro, Brazil. dudupaulino@globo.com.'}, {'ForeName': 'Andreia Cristina', 'Initials': 'AC', 'LastName': 'de Melo', 'Affiliation': 'Brazilian National Cancer Institute and Grupo Oncoclínicas, Rio de Janeiro, Brazil.'}]",Journal of gynecologic oncology,['10.3802/jgo.2020.31.e95']
1266,33078615,"Ingestion of Fecal Bacteria along Multiple Pathways by Young Children in Rural Bangladesh Participating in a Cluster-Randomized Trial of Water, Sanitation, and Hygiene Interventions (WASH Benefits).","Quantifying the contribution of individual exposure pathways to a child's total ingestion of fecal matter could help prioritize interventions to reduce environmental enteropathy and diarrhea. This study used data on fecal contamination of drinking water, food, soil, hands, and objects and second-by-second data on children's contacts with these environmental reservoirs in rural Bangladesh to assess the relative contribution of different pathways to children's ingestion of fecal indicator bacteria and if ingestion decreased with the water, sanitation, and hygiene interventions implemented in the WASH Benefits Trial. Our model estimated that rural Bangladeshi children <36 months old consume 3.6-4.9 log 10 most probable number E. coli /day. Among children <6 months, placing objects in the mouth accounted for 60% of E. coli ingested. For children 6-35 months old, mouthing their own hands, direct soil ingestion, and ingestion of contaminated food were the primary pathways of E. coli ingestion. The amount of E. coli ingested by children and the predominant pathways of E. coli ingestion were unchanged by the water, sanitation, and hygiene interventions. These results highlight contaminated soil, children's hands, food, and objects as primary pathways of E. coli ingestion and emphasize the value of intervening along these pathways.",2020,"The amount of E. coli ingested by children and the predominant pathways of E. coli ingestion were unchanged by the water, sanitation, and hygiene interventions.","[""children's contacts with these environmental reservoirs in rural Bangladesh"", 'Young Children in Rural Bangladesh', 'rural Bangladeshi children <36 months old consume 3.6-4.9 log 10 most probable number E. coli /day']",[],"['fecal contamination of drinking water, food, soil, hands, and objects and second']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0442537', 'cui_str': 'Reservoir'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],"[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",,0.0323596,"The amount of E. coli ingested by children and the predominant pathways of E. coli ingestion were unchanged by the water, sanitation, and hygiene interventions.","[{'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Kwong', 'Affiliation': 'Woods Institute for the Environment, Stanford University, Stanford, California 94305, United States.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Ercumen', 'Affiliation': 'Department of Forestry and Environmental Resources, North Carolina State University, Raleigh, North Carolina 27695, United States.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Pickering', 'Affiliation': 'Department of Civil and Environmental Engineering, Tufts University, Medford, Massachusetts 02155, United States.'}, {'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Arsenault', 'Affiliation': 'Program in International Community Nutrition, University of California, Davis, California 95616, United States.'}, {'ForeName': 'Mahfuza', 'Initials': 'M', 'LastName': 'Islam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1000, Bangladesh.'}, {'ForeName': 'Sarker M', 'Initials': 'SM', 'LastName': 'Parvez', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1000, Bangladesh.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Unicomb', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1000, Bangladesh.'}, {'ForeName': 'Mahbubur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1000, Bangladesh.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Woods Institute for the Environment, Stanford University, Stanford, California 94305, United States.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Woods Institute for the Environment, Stanford University, Stanford, California 94305, United States.'}]",Environmental science & technology,['10.1021/acs.est.0c02606']
1267,33078961,System providing automated feedback improves task learning outcomes during child restraint system (CRS) installations.,"OBJECTIVES
The objective was to build and test an automated, interactive educational system to teach adults how to install a child restraint system (CRS) into a vehicle seat.
METHODS
The automated feedback system (AFS) consisted of a mockup vehicle fixture, convertible CRS, and doll. Sensors were implemented into the equipment so that forward-facing (FF) CRS installation errors could be detected. An interactive display monitor guided users through the CRS installation process and alerted them when steps were done incorrectly. Sixty adult volunteers were recruited and randomized into either the treatment group or the control group. The treatment group used the AFS to guide them through a practice installation. The control group also completed a practice installation using the same equipment fixture without the feedback feature turned on; they only had standard printed instruction manuals to guide their tasks. Then, participants from both groups completed a second CRS installation in a real vehicle with standard instruction manuals only. The frequencies and types of errors in all the installations were evaluated by a Child Passenger Safety Technician (CPST). Error rates were compared between the treatment and control groups using lower-tailed t-tests and Pearson's chi-square tests. Error rates were evaluated considering minor and serious errors together and also considering serious errors alone.
RESULTS
Compared to the control group, participants who trained with the AFS exhibited fewer overall errors (minor and serious) in their fixture installations (p < 0.0001) as well as their follow-up vehicle installations (p < 0.0001). Specifically, participants in the treatment group had fewer errors in choosing an installation method, locking the seat belt (SB), tightening the SB or lower anchors (LA), and tightening the harness (p = 0.0002, p = 0.0003, p = 0.0084, and p = 0.0098, respectively, compared to control group during follow-up vehicle installations). The treatment group also performed significantly better than the control group when only serious errors were considered.
CONCLUSIONS
An automated feedback system is an effective way to teach basic CRS installation skills to users.",2020,"Compared to the control group, participants who trained with the AFS exhibited fewer overall errors (minor and serious) in their fixture installations (p < 0.0001) as well as their follow-up vehicle installations (p < 0.0001).","['Sixty adult volunteers', 'child restraint system (CRS) installations']","['System providing automated feedback', 'practice installation using the same equipment fixture without the feedback feature turned on; they only had standard printed instruction manuals to guide their tasks']","['overall errors', 'Error rates', 'errors in choosing an installation method, locking the seat belt (SB), tightening the SB or lower anchors (LA), and tightening the harness', 'task learning outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C2718030', 'cui_str': 'Child Restraint Systems'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0036498', 'cui_str': 'Seat belt'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C3873748', 'cui_str': 'Harness'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.0470091,"Compared to the control group, participants who trained with the AFS exhibited fewer overall errors (minor and serious) in their fixture installations (p < 0.0001) as well as their follow-up vehicle installations (p < 0.0001).","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Mansfield', 'Affiliation': 'Injury Biomechanics Research Center, School of Health and Rehabilitation Sciences, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Bolte', 'Affiliation': 'Injury Biomechanics Research Center, School of Health and Rehabilitation Sciences, The Ohio State University, Columbus, Ohio.'}]",Traffic injury prevention,['10.1080/15389588.2020.1829607']
1268,33075444,Fostering infant food texture acceptance: A pilot intervention promoting food texture introduction between 8 and 15 months.,"Healthy infant feeding practices form the basis of healthy eating behaviour later in life. The effect of providing parents with recommendations on textured food introduction between 8 and 15 months on children's experience with and acceptance of textured foods was studied. Sixty parent/child dyads were randomly assigned to a control group (CG) receiving current French recommendations and an intervention group (IG) receiving a brochure with supplementary advice, tips and monthly counselling on food texture introduction. After the intervention, parents completed self-report measures about the introduction of 188 food items, including purees, soft/small pieces, hard/large pieces and double textures. Children's acceptance of eight textured foods was assessed in a laboratory setting. Parents in the IG introduced more soft/small food pieces (P = 0.004) but not more complex textures (P = 0.15). There was no group difference in children acceptance for any of the textured foods offered in the laboratory. Independent of their study group, children's exposure to texture was associated with birth order, self-feeding with fingers, low gagging frequency and seldom use of commercial baby foods. Higher acceptance was associated with higher exposure to food pieces but not to pureed foods (either smooth or rough) and with children's eating behavioural traits (high food enjoyment, high food responsiveness and low food fussiness). This pilot intervention demonstrated that providing information can be effective in promoting the introduction of small and soft food pieces, but the most effective way to influence the introduction of more challenging textures (hard pieces and double texture) is uncertain. Further research should focus on the identification of barriers to complex texture introduction and on how building on this knowledge for a population-based public health intervention.",2020,Parents in the IG introduced more soft/small food pieces (P = 0.004) but not more complex textures (P = 0.15).,"['Healthy infant feeding practices form the basis of healthy eating behaviour later in life', 'Sixty parent/child dyads']","['control group (CG) receiving current French recommendations and an intervention group (IG) receiving a brochure with supplementary advice, tips and monthly counselling on food texture introduction']","['soft/small food pieces', 'children acceptance']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0449582', 'cui_str': 'With texture'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",,0.0391997,Parents in the IG introduced more soft/small food pieces (P = 0.004) but not more complex textures (P = 0.15).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tournier', 'Affiliation': ""UMR Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France. Electronic address: carole.tournier@inrae.fr.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bernad', 'Affiliation': ""UMR Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Madrelle', 'Affiliation': ""UMR Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Delarue', 'Affiliation': 'UMR SayFood, Université Paris-Saclay, INRAE, AgroParisTech, F-91300, Massy, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cuvelier', 'Affiliation': 'UMR SayFood, Université Paris-Saclay, INRAE, AgroParisTech, F-91300, Massy, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schwartz', 'Affiliation': ""UMR Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nicklaus', 'Affiliation': ""UMR Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}]",Appetite,['10.1016/j.appet.2020.104989']
1269,33075592,Quantifying regional variations in components of acute stroke unit (ASU) care in the international HeadPoST study.,"OBJECTIVE
Access to acute stroke unit (ASU) care is known to vary worldwide. We aimed to quantify regional variations in the various components of ASU care.
METHOD
Secondary analysis of the Head Positioning in acute Stroke Trial (HeadPoST), an international, multicentre, cluster crossover trial of head-up versus head-down positioning in 11,093 acute stroke patients at 114 hospitals in 9 countries. Patients characteristics and 11 standard components of processes of care were described according to ASU admission within and across four economically-defined regional groups (Australia/UK, China [includes Taiwan], India/Sri Lanka, and South America [Brazil/Chile/Colombia]). Variations in process of ASU care estimates were obtained in hierarchical mixed models, with adjustment for study design and potential patient- and hospital-level confounders.
RESULTS
Of 11,086 patients included in analyses, 59.7% (n = 6620) had an ASU admission. In China, India/Sri Lanka and South America, ASU patients were older, had greater neurological severity and more premorbid conditions than non-ASU patients. ASU patients were more likely to receive reperfusion therapy and multidisciplinary care within regions, but the components of care varied across regions. With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12-0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy).
CONCLUSION
There is significant variation in the components of stroke care across economically-defined regions of the world. Ongoing efforts are required to reduce disparities and optimise health outcomes, especially in resource poor areas.
CLINICAL TRIAL REGISTRATION
HeadPoST is registered at ClinicalTrials.gov (NCT02162017).",2020,"With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12-0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy).
","['Patients characteristics and 11 standard components of processes of care were described according to ASU admission within and across four economically-defined regional groups (Australia/UK, China [includes Taiwan], India/Sri Lanka, and South America', 'Secondary analysis of the Head Positioning in acute Stroke Trial ', '11,093 acute stroke patients at 114 hospitals in 9 countries', 'Of 11,086 patients included in analyses, 59.7% (n\xa0=\xa06620) had an ASU admission']","['HeadPoST', 'head-up versus head-down positioning']",['probability of receiving reperfusion therapy'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0582540', 'cui_str': 'Head position finding'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1293898', 'cui_str': 'Head up'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]",,0.177773,"With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12-0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy).
","[{'ForeName': 'Menglu', 'Initials': 'M', 'LastName': 'Ouyang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, Shenyang First People's Hospital, Shenyang, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Pablo M', 'Initials': 'PM', 'LastName': 'Lavados', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurologia y Psiquiatria, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Chile.'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; Faculty of Health and Wellbeing, University of Central Lancashire, Preston, Lancashire, UK.'}, {'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Olavarría', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurologia y Psiquiatria, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Chile.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Muñoz-Venturelli', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; Centro de Estudios Clínicos, Instituto de Ciencias e Innovación en Medicina, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': ""Nursing Research Institute, St Vincent's Health Network Sydney, St Vincent's Hospital, Melbourne and Australian Catholic University, Sydney, Australia.""}, {'ForeName': 'Caroline L', 'Initials': 'CL', 'LastName': 'Watkins', 'Affiliation': 'Faculty of Health and Wellbeing, University of Central Lancashire, Preston, Lancashire, UK.'}, {'ForeName': 'Octavio M', 'Initials': 'OM', 'LastName': 'Pontes-Neto', 'Affiliation': 'Stroke Service - Neurology Division, Department of Neuroscience and Behavioral Sciences, Ribeirão Preto Medical School, University of Sao Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Tsong-Hai', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Stroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Alejandro M', 'Initials': 'AM', 'LastName': 'Brunser', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurologia y Psiquiatria, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Chile.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, China; Centro de Estudios Clínicos, Instituto de Ciencias e Innovación en Medicina, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile; Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, Australia; Heart Health Research Center, Beijing, China. Electronic address: canderson@georgeinstitute.org.au.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117187']
1270,33075644,Additive effectiveness and feasibility of a theory-driven instant assessment and feedback system in brief cannabis intervention: A randomised controlled trial.,"Assessment and personalised feedback are important components of brief interventions (BIs) for cannabis use. A key outcome is to increase motivation to change during this short interaction. The diversity of available assessments and time burden scoring them pose a challenge for routine use in clinical practice. An instant assessment and feedback (iAx) system was developed to administer assessments informed by bioSocial Cognitive Theory, that were instantly scored and benchmarked against clinical norms, to provide patient feedback and guide treatment planning. This study evaluated the feasibility and additive effectiveness of the iAx on motivation to change cannabis use, when compared to treatment as usual (TAU), in a single-session BI. A randomised controlled trial was conducted in a public hospital alcohol and drug outpatient clinic. Eighty-seven cannabis users (M age = 26.41; 66% male) were assigned to the BI utilising the iAx (iAx; n = 44) or to the standard BI (TAU; n = 43). Patients completed pre- and post-BI assessments of motivation to change and a post-BI measure of treatment satisfaction. Practitioners completed a feedback survey. Patients receiving iAx reported a significantly greater increase in motivation to change from pre- to post-BI compared to patients receiving TAU (d = 0.49, p = .03). Treatment satisfaction was high across both conditions, with no significant difference between groups (p = .57). Practitioners also reported a high level of satisfaction with the iAx system. In summary, findings support the feasibility and additive effectiveness of the iAx to enhance patient motivation during cannabis BI.",2020,"Treatment satisfaction was high across both conditions, with no significant difference between groups (p = .57).","['Eighty-seven cannabis users (M age \xa0=\xa026.41; 66% male', 'brief cannabis intervention', 'public hospital alcohol and drug outpatient clinic']",['theory-driven instant assessment and feedback system'],"['Treatment satisfaction', 'motivation']","[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",87.0,0.0509742,"Treatment satisfaction was high across both conditions, with no significant difference between groups (p = .57).","[{'ForeName': 'Zoë E', 'Initials': 'ZE', 'LastName': 'Papinczak', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD 4072, Australia; School of Psychology, The University of Queensland, Brisbane, QLD 4072, Australia.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Connor', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD 4072, Australia; Discipline of Psychiatry, School of Medicine, The University of Queensland, Brisbane, QLD 4029, Australia; Alcohol and Drug Assessment Unit, Princess Alexandra Hospital, Brisbane, QLD 4102, Australia.'}, {'ForeName': 'Gerald F X', 'Initials': 'GFX', 'LastName': 'Feeney', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD 4072, Australia; Alcohol and Drug Assessment Unit, Princess Alexandra Hospital, Brisbane, QLD 4102, Australia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gullo', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD 4072, Australia; Alcohol and Drug Assessment Unit, Princess Alexandra Hospital, Brisbane, QLD 4102, Australia. Electronic address: m.gullo@uq.edu.au.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106690']
1271,33091438,The placebo effect in breath holding: a preliminary behavioral investigation.,"PURPOSE
This study seeks to evaluate effects of expectations and conditioning on dry breath holding.
METHODS
Sixty healthy volunteers were subdivided into 3 groups and were tested across 4 breath holding trials. Participants of the Control group (C) did not undergo any manipulation. Participants of the placebo (P) and nocebo (N) groups were told that they would inhale O2 (actually sham O2) or CO2 (actually sham CO2) along with opposite information that this would enhance or worsen their breath holding time, respectively. Opposite conditioning paradigms based on false visual feedback were employed to reinforce participants' positive (placebo) and negative (nocebo) beliefs.
RESULTS
The P group showed the greater increase in breath holding time from baseline to the last trial (p = 0.0001) and the longest breath holding time in the last trial compared to the C group (p = 0.02) and the N group (p = 0.0001). Additionally, in the last trial the P group showed a greater decrease in peripheral oxygen saturation (SpO2) as compared to the C group (p = 0.04) and the N group (p = 0.001). Heart rate (HR) was accelerated in the N group during breath holding (in comparison to the P group [p = 0.04] and C group [p = 0.04]).
CONCLUSIONS
Psychological components can affect behavioral and physiological parameters in breath holding. This study may inform future research about the role of placebo and nocebo effects for conditions in which critical functions are at play.",2020,The P group showed the greater increase in breath holding time from baseline to the last trial (p = 0.0001) and the longest breath holding time in the last trial compared to the C group (p = 0.02) and the N group (p = 0.0001).,['Sixty healthy volunteers'],"['placebo', 'placebo (P) and nocebo (N) groups were told that they would inhale O2 (actually sham O2) or CO2 (actually sham CO2']","['breath holding time', 'longest breath holding time', 'peripheral oxygen saturation (SpO2', 'Heart rate (HR']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]","[{'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",60.0,0.145215,The P group showed the greater increase in breath holding time from baseline to the last trial (p = 0.0001) and the longest breath holding time in the last trial compared to the C group (p = 0.02) and the N group (p = 0.0001).,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Piedimonte', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy.'}, {'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Barbiani', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Benedetti', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy; Medicine & Physiology of Hypoxia, Plateau Rosa Laboratories, Breuil-Cervinia, Italy, Zermatt, Switzerland.'}, {'ForeName': 'Denisa Adina', 'Initials': 'DA', 'LastName': 'Zamfira', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Carlino', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy. Electronic address: elisa.carlino@unito.it.'}]",Neuroscience letters,['10.1016/j.neulet.2020.135434']
1272,33091586,Cognitive behavioral therapy for insomnia to enhance cognitive function and reduce the rate of Aβ deposition in older adults with symptoms of insomnia: A single-site randomized pilot clinical trial protocol.,"Lifestyle interventions to increase exercise and improve diet have been the focus of recent clinical trials to potentially prevent Alzheimer's disease (AD). However, despite the strong links between sleep disruptions, cognitive decline, and AD, sleep enhancement has yet to be targeted as a lifestyle intervention to prevent AD. A recent meta-analysis suggests that approximately 15% of AD may be prevented by an efficacious intervention aimed to reduce sleep disturbances and sleep disorders. Chronic insomnia is the most frequent sleep disorder occurring in at least 40% of older adults. Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD) and demonstrate decline in cognitive function at long-term follow-up. AD is characterized by the accumulation of amyloid-β (Aβ) plaques and tau tangles in the brain, and growing evidence shows impaired sleep contributes to the accumulation of Aβ. An intervention aimed at improving insomnia may be a critical opportunity for primary prevention to slow cognitive decline and potentially delay the onset of AD. Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious treatment for insomnia, but the use of CBT-I to improve cognitive function and potentially reduce the rate of Aβ accumulation has never been examined. Therefore, the objective of the proposed study is to examine the efficacy of CBT-I on improving cognitive function in older adults with symptoms of insomnia. An exploratory aim is to assess the effect of CBT-I on rate of Aβ accumulation.",2020,Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD),"[""Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD"", 'older adults with symptoms of insomnia']","['CBT-I', 'Cognitive behavioral therapy']","['rate of Aβ deposition', 'Chronic insomnia', 'cognitive function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0637426,Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD),"[{'ForeName': 'Catherine F', 'Initials': 'CF', 'LastName': 'Siengsukon', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America. Electronic address: csiengsukon@kumc.edu.'}, {'ForeName': 'Eryen', 'Initials': 'E', 'LastName': 'Nelson', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Cierra', 'Initials': 'C', 'LastName': 'Williams-Cooke', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ludwig', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Eber Silveira', 'Initials': 'ES', 'LastName': 'Beck', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, United States of America.""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Mahnken', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, United States of America; Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, KS, United States of America.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Stevens', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Drerup', 'Affiliation': 'Sleep Disorders Clinic, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Department of Biomedical and Health Informatics, University of Missouri - Kansas City School of Medicine, Kansas City, MO, United States of America.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Burns', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106190']
1273,33091587,Safer use of antipsychotics in youth (SUAY) pragmatic trial protocol.,"BACKGROUND
Programs such as the Pediatric Access Line in Washington state have shown decreases in antipsychotic medication use by youth with non-psychotic disorders. Program outcomes have been studied with observational designs. This manuscript describes the protocol for Targeted and Safer Use of Antipsychotics in Youth (SUAY), a randomized controlled trial of psychiatrist review of prescriptions and facilitated access to psychosocial care. The aim of the intervention is to reduce the number of person-days of antipsychotic use among participants.
METHODS
Recruitment occurs at 4 health systems. Targeted enrollment is 800 youth aged 3-17 years. Clinicians are block randomized to intervention versus usual care prior to the study. Youth are nested within the arm of the prescribing clinician. Clinicians in the intervention group receive an EHR-based best practice alert with options to expedite access to psychosocial care and all medication orders are reviewed by a child and adolescent psychiatrist with feedback provided to the prescriber. The primary outcome is person-days of antipsychotic medication use in the 6 months following the initial order. All randomized individuals contribute data regardless of their level of participation (including declining all services).
DISCUSSION
The trial has been approved by the institutional review boards at each of the 4 sites. The intervention has 4 novel design features including automated recruitment using a best practice alert, psychiatrist medication order review and consultation, telephone navigation to psychosocial care, and telemental health visits. Recruitment began in March of 2018 and will be completed in June 2020. Follow-up will be completed December 31, 2020.
TRIAL REGISTRATION
Clinicaltrials.gov, NCT03448575.",2020,"The intervention has 4 novel design features including automated recruitment using a best practice alert, psychiatrist medication order review and consultation, telephone navigation to psychosocial care, and telemental health visits.","['Youth (SUAY', '800 youth aged 3-17\u202fyears', 'Recruitment occurs at 4 health systems', 'youth with non-psychotic disorders', 'participants']","['EHR-based best practice alert with options to expedite access to psychosocial care', 'antipsychotics']",['person-days of antipsychotic medication use'],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1455743', 'cui_str': 'Psychosocial assessment'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0803332,"The intervention has 4 novel design features including automated recruitment using a best practice alert, psychiatrist medication order review and consultation, telephone navigation to psychosocial care, and telemental health visits.","[{'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Penfold', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA. Electronic address: Robert.B.Penfold@kp.org.'}, {'ForeName': 'Ella E', 'Initials': 'EE', 'LastName': 'Thompson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hilt', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Kelleher', 'Affiliation': ""Nationwide Children's Hospital, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Schwartz', 'Affiliation': ""Nationwide Children's Hospital, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Beck', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Denver, CO, USA.'}, {'ForeName': 'Gregory N', 'Initials': 'GN', 'LastName': 'Clarke', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, Portland, OR, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Ralston', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Hartzler', 'Affiliation': 'Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R Yates', 'Initials': 'RY', 'LastName': 'Coley', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Akosile', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Benedetto', 'Initials': 'B', 'LastName': 'Vitiello', 'Affiliation': 'Dipartimento di Scienze della Sanità Pubblica e Pediatriche, University of Turin, Turin, Italy.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Simon', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106184']
1274,33091589,Treatment of comorbid sleep disorders and posttraumatic stress disorder in active duty military: Design and methodology of a randomized clinical trial.,"Many individuals with posttraumatic stress disorder (PTSD) also suffer from insomnia and nightmares, which may be symptoms of PTSD or constitute partially independent comorbid disorders. Sleep disturbances are resistant to current treatments for PTSD, and those suffering from PTSD, insomnia, and nightmares have worse PTSD treatment outcomes. In addition, insomnia and nightmares are risk factors for depression, substance abuse, anxiety, and suicide. Cognitive-Behavioral Therapy for Insomnia and Nightmares (CBT-I&N) and Cognitive Processing Therapy (CPT) for PTSD are first line treatments of these conditions. CPT does not typically address insomnia or nightmares, and CBT-I&N does not typically address other symptoms of PTSD. There are limited scientific data on how best to provide these therapies to individuals suffering with all three disorders. This project aims to inform the most effective way to treat individuals suffering from PTSD, insomnia, and nightmares, potentially changing the standard of care. U.S. military personnel and recently discharged Veterans who served in support of combat operations following 9/11 aged 18-65 with PTSD, insomnia, and nightmares (N = 222) will be randomly assigned to one of the following 18-session individual treatment conditions delivered over 12-weeks: (1) 6 sessions of CBT-I&N followed by 12 sessions of CPT; (2) 12 sessions of CPT followed by 6 sessions of CBT-I&N; or (3) 12 sessions of CPT followed by an additional 6 sessions of CPT. All participants will be assessed at baseline, during treatment, and at 1-week, 1-month, 3-months, and 6-months posttreatment. The primary outcome will be PTSD symptom severity.",2020,Cognitive-Behavioral Therapy for Insomnia and Nightmares (CBT-I&N) and Cognitive Processing Therapy (CPT) for PTSD are first line treatments of these conditions.,"['individuals with posttraumatic stress disorder (PTSD', 'individuals suffering with all three disorders', 'comorbid sleep disorders and posttraumatic stress disorder in active duty military', 'U.S. military personnel and recently discharged Veterans who served in support of combat operations following 9/11 aged 18-65 with PTSD, insomnia, and nightmares (N\u202f=\u202f222']","['18-session individual treatment conditions delivered over 12-weeks', 'Cognitive-Behavioral Therapy', 'Cognitive Processing Therapy (CPT', 'CPT']","['Sleep disturbances', 'PTSD symptom severity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",222.0,0.0167908,Cognitive-Behavioral Therapy for Insomnia and Nightmares (CBT-I&N) and Cognitive Processing Therapy (CPT) for PTSD are first line treatments of these conditions.,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX 76203-5017, USA. Electronic address: DanielJTaylor@arizona.edu.'}, {'ForeName': 'Kristi E', 'Initials': 'KE', 'LastName': 'Pruiksma', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA. Electronic address: Pruiksma@uthscsa.edu.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA. Electronic address: Mintz@uthscsa.edu.'}, {'ForeName': 'Danica C', 'Initials': 'DC', 'LastName': 'Slavish', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX 76203-5017, USA. Electronic address: Danica.Slavish@unt.edu.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Wardle-Pinkston', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX 76203-5017, USA. Electronic address: swpinkston@email.arizona.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Tyler', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA. Electronic address: TylerH@uthscsa.edu.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA. Electronic address: Dondanville@uthscsa.edu.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA. Electronic address: Youngs1@uthscsa.edu.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Scullin', 'Affiliation': 'Department of Psychology and Neuroscience, Baylor University, One Bear Place 97334, Waco, TX 76798, USA. Electronic address: Michael_Scullin@baylor.edu.'}, {'ForeName': 'Karin L', 'Initials': 'KL', 'LastName': 'Nicholson', 'Affiliation': 'Carl R. Darnall Army Medical Center, 36065 Santa Fe Ave., Fort Hood, TX 76544, USA. Electronic address: Karin.L.Nicholson.mil@mail.mil.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'Massachusetts Veterans Epidemiological Research and Information Center, VA Boston Healthcare System, 150 Hungtington Ave., Boston, MA 02130, USA; Department of Psychiatry, Boston University School of Medicine, 72 East Concord St., Boston, MA 02118, USA; Department of Psychological and Brain Sciences, Boston University, 64 Cummington Mall, Boston, MA 02215, USA. Electronic address: LitzB@bu.edu.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Dietch', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX 76203-5017, USA. Electronic address: Jessica.Dietch@va.gov.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Williamson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 1121 West Chapel Hill Street, Suite 201, Durham, NC 27701, USA; Durham VA Health Care System, Durham, NC, USA. Electronic address: douglas.williamson@duke.edu.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Keane', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, 72 East Concord St., Boston, MA 02118, USA; Behavioral Science Division, National Center for PTSD, VA Boston Healthcare System, 150 South Huntington Ave., Boston, MA 02130, USA. Electronic address: Terry.Keane@va.gov.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA; Research and Development Service, South Texas Veterans Health Care System, 7400 Merton Minter, San Antonio, TX 78229, USA; Department of Psychology, University of Texas at San Antonio, 1 UTSA Circle, San Antonio, TX 78249, USA. Electronic address: Petersona3@uthscsa.edu.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Resick', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 1121 West Chapel Hill Street, Suite 201, Durham, NC 27701, USA. Electronic address: Patricia.Resick@duke.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106186']
1275,33091614,Acute and chronic effects of high-intensity interval and moderate-intensity continuous exercise on heart rate and its variability after recent myocardial infarction: A randomized controlled trial.,"BACKGROUND
Resting heart rate (HR) and HR variability (HRV) are known to predict mortality in patients after myocardial infarction (MI).
OBJECTIVE
We assessed acute and chronic effects of high-intensity interval training (HIIT) versus moderate-intensity continuous exercise (MICE) on HR and HRV in individuals after acute ST-segment elevation MI (STEMI).
METHODS
Participants within 7 weeks after MI were randomly assigned to HIIT or MICE groups for a 9-week intervention. HR and the power spectrum of HRV were measured pre- and post-intervention by using orthostatic challenge and during sleep to assess chronic effects. Sleep measurements were performed at night after HIIT, MICE or no training to assess acute effects. Mixed models assessed time*group interaction for differences in chronic and acute effects, adjusted for beta-blocker dose and number of training sessions.
RESULTS
Overall, 34 of 37 and 35 of 36 participants in the HIIT and MICE groups completed the study. We found a trend for an acute increase in HR of 2.5 bpm (4%, P=0.023) during sleep after HIIT. We found a trend for a chronic decrease in HR during supine and standing position as well as during sleep in the MICE group but a trend for an increase in HR during supine and standing position in the HIIT group. Low- and high-frequency power (LF, HF) of the standing segment increased from pre- to post-intervention in the MICE group but decreased in the HIIT group (group*time interaction P=0.005 and P=0.026, respectively).
CONCLUSION
HR during sleep tended to be increased acutely during the night after HIIT but not after MICE as compared with controls. Chronic effects on resting HR, HF and LF tended to be more beneficial after MICE than HIIT in individuals with recent STEMI.",2020,"Chronic effects on resting HR, HF and LF tended to be more beneficial after MICE than HIIT in individuals with recent STEMI.","['patients after myocardial infarction (MI', 'Participants within 7 weeks after MI', 'individuals after acute ST-segment elevation MI (STEMI']","['HIIT or MICE', 'high-intensity interval training (HIIT) versus moderate-intensity continuous exercise (MICE', 'high-intensity interval and moderate-intensity continuous exercise']","['Low- and high-frequency power (LF, HF) of the standing segment', 'heart rate', 'heart rate (HR) and HR variability (HRV', 'Sleep measurements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]",,0.112169,"Chronic effects on resting HR, HF and LF tended to be more beneficial after MICE than HIIT in individuals with recent STEMI.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Eser', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland. Electronic address: prisca.eser@insel.ch.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jaeger', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland; Department of Sport, Exercise and Health, Medical Faculty, University of Basel, 4052 Basel, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Marcin', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Herzig', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland; Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Bern University Hospital and University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'L D', 'Initials': 'LD', 'LastName': 'Trachsel', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.09.008']
1276,33092591,Salbutamol use in relation to maintenance bronchodilator efficacy in COPD: a prospective subgroup analysis of the EMAX trial.,"BACKGROUND
Short-acting β 2 -agonist (SABA) bronchodilators help alleviate symptoms in chronic obstructive pulmonary disease (COPD) and may be a useful marker of symptom severity. This analysis investigated whether SABA use impacts treatment differences between maintenance dual- and mono-bronchodilators in patients with COPD.
METHODS
The Early MAXimisation of bronchodilation for improving COPD stability (EMAX) trial randomised symptomatic patients with low exacerbation risk not receiving inhaled corticosteroids 1:1:1 to once-daily umeclidinium/vilanterol 62.5/25 μg, once-daily umeclidinium 62.5 μg or twice-daily salmeterol 50 μg for 24 weeks. Pre-specified subgroup analyses stratified patients by median baseline SABA use (low, < 1.5 puffs/day; high, ≥1.5 puffs/day) to examine change from baseline in trough forced expiratory volume in 1 s (FEV 1 ), change in symptoms (Transition Dyspnoea Index [TDI], Evaluating Respiratory Symptoms-COPD [E-RS]), daily SABA use and exacerbation risk. A post hoc analysis used fractional polynomial modelling with continuous transformations of baseline SABA use covariates.
RESULTS
At baseline, patients in the high SABA use subgroup (mean: 3.91 puffs/day, n = 1212) had more severe airflow limitation, were more symptomatic and had worse health status versus patients in the low SABA use subgroup (0.39 puffs/day, n = 1206). Patients treated with umeclidinium/vilanterol versus umeclidinium demonstrated statistically significant improvements in trough FEV 1 at Week 24 in both SABA subgroups (59-74 mL; p < 0.001); however, only low SABA users demonstrated significant improvements in TDI (high: 0.27 [p = 0.241]; low: 0.49 [p = 0.025]) and E-RS (high: 0.48 [p = 0.138]; low: 0.60 [p = 0.034]) scores. By contrast, significant reductions in mean SABA puffs/day with umeclidinium/vilanterol versus umeclidinium were observed only in high SABA users (high: - 0.56 [p < 0.001]; low: - 0.10 [p = 0.132]). Similar findings were observed when comparing umeclidinium/vilanterol and salmeterol. Fractional polynomial modelling showed baseline SABA use ≥4 puffs/day resulted in smaller incremental symptom improvements with umeclidinium/vilanterol versus umeclidinium compared with baseline SABA use < 4 puffs/day.
CONCLUSIONS
In high SABA users, there may be a smaller difference in treatment response between dual- and mono-bronchodilator therapy; the reasons for this require further investigation. SABA use may be a confounding factor in bronchodilator trials and in high SABA users; changes in SABA use may be considered a robust symptom outcome.
FUNDING
GlaxoSmithKline (study number 201749 [NCT03034915]).",2020,"Patients treated with umeclidinium/vilanterol versus umeclidinium demonstrated statistically significant improvements in trough FEV 1 at Week 24 in both SABA subgroups (59-74 mL; p < 0.001); however, only low SABA users demonstrated significant improvements in TDI (high: 0.27 [p = 0.241]; low: 0.49 [p = 0.025]) and E-RS (high: 0.48 [p = 0.138]; low: 0.60 [p = 0.034]) scores.","['symptomatic patients with low exacerbation risk not receiving inhaled corticosteroids 1:1:1 to once-daily umeclidinium/vilanterol 62.5/25', 'chronic obstructive pulmonary disease (COPD', 'patients with COPD', 'COPD']","['SABA', 'agonist (SABA) bronchodilators', 'Salbutamol', 'umeclidinium 62.5\u2009μg or twice-daily salmeterol', 'umeclidinium/vilanterol versus umeclidinium']","['severe airflow limitation', 'TDI', 'trough FEV', 'mean SABA puffs/day with umeclidinium/vilanterol versus umeclidinium', 'change in symptoms (Transition Dyspnoea Index [TDI], Evaluating Respiratory Symptoms-COPD [E-RS]), daily SABA use and exacerbation risk', 'health status']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",,0.389575,"Patients treated with umeclidinium/vilanterol versus umeclidinium demonstrated statistically significant improvements in trough FEV 1 at Week 24 in both SABA subgroups (59-74 mL; p < 0.001); however, only low SABA users demonstrated significant improvements in TDI (high: 0.27 [p = 0.241]; low: 0.49 [p = 0.025]) and E-RS (high: 0.48 [p = 0.138]; low: 0.60 [p = 0.034]) scores.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'Centre de Pneumologie, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Québec, QC, Canada. Francois.Maltais@fmed.ulaval.ca.'}, {'ForeName': 'I P', 'Initials': 'IP', 'LastName': 'Naya', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany.'}, {'ForeName': 'I H', 'Initials': 'IH', 'LastName': 'Boucot', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Jones', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bjermer', 'Affiliation': 'Respiratory Medicine and Allergology, Lund University, Lund, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tombs', 'Affiliation': 'Precise Approach Ltd, contingent worker on assignment at GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Compton', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'Respiratory Clinical Sciences, GSK, Collegeville, PA, USA.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Kerwin', 'Affiliation': 'Clinical Research Institute of Southern Oregon, Medford, OR, USA.'}]",Respiratory research,['10.1186/s12931-020-01451-8']
1277,33074299,Intraocular Pressure Decrease Does Not Affect Blood Flow Rate of Ophthalmic Artery in Ocular Hypertension.,"Purpose
To investigate if decrease of IOP affects the volumetric blood flow rate in the ophthalmic artery (OA) in patients with previously untreated ocular hypertension.
Methods
Subjects with untreated ocular hypertension (n = 30; mean age 67 ± 8 years; 14 females) underwent ophthalmologic examination and a 3-Tesla magnetic resonance imaging investigation. The magnetic resonance imaging included three-dimensional high-resolution phase-contrast magnetic resonance imaging to measure the OA blood flow rate. The subjects received latanoprost once daily in the eye with higher pressure, the untreated eye served as control. The same measurements were repeated approximately 1 week later.
Results
The mean OA blood flow rate before and after treatment was 12.4 ± 4.4 and 12.4 ± 4.6 mL/min in the treated eye (mean ± SD; P = 0.92) and 13.5 ± 5.2 and 13.4 ± 4.1 mL/min in the control eye (P = 0.92). There was no significant difference between the treated and control eye regarding blood flow rate before (P = 0.13) or after treatment (P = 0.18), or change in blood flow rate after treatment (0.1 ± 3.1 vs. -0.1 ± 4.0 mL/min, P = 0.84). Latanoprost decreased the IOP by 7.2 ± 3.1 mm Hg in the treated eye (P < 0.01).
Conclusions
The results indicate that a significant lowering of IOP does not affect the blood flow rate of the OA in ocular hypertension subjects. The ability to maintain blood supply to the eye independent of the IOP could be a protective mechanism in preserving vision in subjects with ocular hypertension.",2020,"There was no significant difference between the treated and control eye regarding blood flow rate before (P = 0.13) or after treatment (P = 0.18), or change in blood flow rate after treatment (0.1 ± 3.1 vs. -0.1 ± 4.0 mL/min, P = 0.84).","['Methods\n\n\nSubjects with untreated ocular hypertension (n = 30; mean age 67 ± 8 years; 14 females) underwent', 'subjects with ocular hypertension', 'ocular hypertension subjects', 'patients with previously untreated ocular hypertension']","['Latanoprost', 'ophthalmic artery (OA', 'ophthalmologic examination and a 3-Tesla magnetic resonance imaging investigation', 'latanoprost']","['Blood Flow Rate', 'mean OA blood flow rate', 'OA blood flow rate', 'blood flow rate', 'IOP']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0029078', 'cui_str': 'Structure of ophthalmic artery'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0029078', 'cui_str': 'Structure of ophthalmic artery'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}]",,0.0319675,"There was no significant difference between the treated and control eye regarding blood flow rate before (P = 0.13) or after treatment (P = 0.18), or change in blood flow rate after treatment (0.1 ± 3.1 vs. -0.1 ± 4.0 mL/min, P = 0.84).","[{'ForeName': 'Gauti', 'Initials': 'G', 'LastName': 'Jóhannesson', 'Affiliation': 'Department of Clinical Sciences, Ophthalmology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Qvarlander', 'Affiliation': 'Department of Radiation Sciences, Biomedical Engineering, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Wåhlin', 'Affiliation': 'Department of Radiation Sciences, Biomedical Engineering, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Ambarki', 'Affiliation': 'Department of Radiation Sciences, Biomedical Engineering, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Hallberg', 'Affiliation': 'Centre for Biomedical Engineering and Physics, Umeå University, Umeå Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Eklund', 'Affiliation': 'Department of Radiation Sciences, Biomedical Engineering, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lindén', 'Affiliation': 'Department of Clinical Sciences, Ophthalmology, Umeå University, Umeå, Sweden.'}]",Investigative ophthalmology & visual science,['10.1167/iovs.61.12.17']
1278,33070354,"Adherence to and acceptability of three alcohol-free, antiseptic oral rinses: A community-based pilot randomized controlled trial among pregnant women in rural Nepal.","OBJECTIVES
Antiseptic oral rinses have been evaluated as interventions to reduce the risk of adverse pregnancy outcomes associated with periodontal disease in pregnant women. Oral rinse use is not common in Nepal or other countries in South Asia, where the prevalence of adverse pregnancy outcomes is high. Understanding whether pregnant women in rural communities in this region would incorporate rinse use into their daily teeth cleaning routine is an important prerequisite to future research on this topic in South Asia.
METHODS
We conducted a community-based pilot randomized controlled trial of three alcohol-free, antiseptic oral rinses among pregnant women <22 weeks pregnant in rural Nepal with the aim of assessing rinse acceptability, adherence, and effect on clinical periodontal measures. At baseline, participants underwent a clinical periodontal examination, and then were classified as healthy or having at least mild gingivitis (≥1 site with probing depth (PD) 3 mm and bleeding on probing (BOP) or ≥4 mm (PD)). Participants were stratified by periodontal status and randomized within each exposure category to chlorhexidine (CHX) (0.12%), cetylpyridinium chloride (CPC) (0.05%), salt and water (NaCl), or control (no rinse). Rinse participants were followed weekly for 12 weeks, and all participants underwent a second periodontal examination and answered a questionnaire.
RESULTS
Pregnant women in the rural Terai region of Nepal showed high adherence to (mean weekly rinse use: 185 mL (standard deviation: 66 mL)) a recommended 210 mL and acceptability of all three rinses. Participants reported greater frequency of tooth brushing with toothpaste and improvements in other recommended oral hygiene behaviours. CHX significantly reduced rates of gingivitis (defined as a participant with BOP ≥ 10% of sites) and the extent of BOP (gingivitis at the end of follow-up for CHX vs control: RR 0.37, 95% CI: 0.16, 0.84). CPC and NaCl rinse groups had rates of gingivitis and extent of BOP similar to the control group (gingivitis at the end of follow-up for CPC: RR 0.81, 95% CI: 0.47, 1.38; NaCl: RR 0.92, 95% CI: 0.55, 1.56).
CONCLUSIONS
Adherence to and acceptability of three alcohol-free, antiseptic oral rinses were high among pregnant women in rural Nepal. Among participants with mild gingivitis at baseline, CHX rinse was most effective at reducing signs of disease compared to the control group. Oral rinse should be considered as a supplement to current oral self-care routines for pregnant women in settings where rinse use is uncommon and access to oral health services is limited.",2020,"CPC and NaCl rinse groups had rates of gingivitis and extent of BOP similar to the control group (gingivitis at the end of follow-up for CPC: RR 0.81, 95% CI: 0.47, 1.38; NaCl: RR 0.92, 95% CI: 0.55, 1.56).
","['participants with mild gingivitis', 'Pregnant women in the rural Terai region of Nepal', 'pregnant women in rural communities', 'pregnant women', 'pregnant women in rural Nepal', 'participants underwent a clinical periodontal examination, and then were classified as healthy or having at least mild gingivitis (≥1 site with probing depth (PD) 3\xa0mm and bleeding on probing (BOP) or ≥4\xa0mm (PD', 'pregnant women <22\xa0weeks pregnant in rural Nepal']","['chlorhexidine (CHX', 'alcohol-free, antiseptic oral rinses', 'cetylpyridinium chloride (CPC) (0.05%), salt and water (NaCl), or control (no rinse', 'CPC and NaCl rinse', 'CHX']","['BOP (gingivitis', 'rates of gingivitis and extent of BOP', 'frequency of tooth brushing', 'rates of gingivitis']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0007907', 'cui_str': 'Cetylpyridinium chloride'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}]",3.0,0.121734,"CPC and NaCl rinse groups had rates of gingivitis and extent of BOP similar to the control group (gingivitis at the end of follow-up for CPC: RR 0.81, 95% CI: 0.47, 1.38; NaCl: RR 0.92, 95% CI: 0.55, 1.56).
","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Erchick', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Nitin K', 'Initials': 'NK', 'LastName': 'Agrawal', 'Affiliation': 'Department of Dentistry, Institute of Medicine, Tribhuhvan University, Kathmandu, Nepal.'}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'Nepal Nutrition Intervention Project - Sarlahi (NNIPS), Kathmandu, Nepal.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'LeClerq', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Reynolds', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, University of Maryland School of Dentistry, Baltimore, MD, USA.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Mullany', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",Community dentistry and oral epidemiology,['10.1111/cdoe.12562']
1279,33069970,Labor neuraxial analgesia and breastfeeding: An updated systematic review.,"INTRODUCTION
There have been numerous reports studying the effect of neuraxial analgesia on breastfeeding success, but the results are inconsistent.
METHODS
We performed a literature search in various databases for studies comparing neuraxial analgesia to non-neuraxial or no analgesia. Outcomes were the percentage of women breastfeeding fully or mixed with formula. Where possible, nulliparous parturients were analyzed separately. We conducted an analysis excluding studies of serious and critical risk of bias. Odds ratios and 95% confidence intervals were calculated.
RESULTS
We included 15 studies (13 observational studies, 1 secondary analysis of a randomized controlled trial, 1 case-control study) with 16,112 participants. Overall, there were 6 studies that found no difference between groups, 6 studies that showed a significantly lower incidence of breastfeeding in the neuraxial group and 3 studies finding mixed results (at some time-points statistically significant and at some time-point statistically non-significant results). In nulliparous only studies, 2 found no difference between study groups, 1 found a lower breastfeeding rate in the neuraxial group and 3 studies showed mixed results. Excluding studies with a serious and critical risk of bias, 1 study found no difference between study groups, 3 studies found a decrease of breastfeeding rates in the neuraxial group, and 1 study showed mixed results.
DISCUSSION
In our review we found a high disparity in results. One reason is probably the high potential of confounding (immediate skin to skin placement, maternity leave etc.). Education programs and breastfeeding support are likely more important in determining long term breastfeeding success.",2020,"Overall, there were 6 studies that found no difference between groups, 6 studies that showed a significantly lower incidence of breastfeeding in the neuraxial group and 3 studies finding mixed results (at some time-points statistically significant and at some time-point statistically non-significant results).","['nulliparous parturients', '15 studies (13 observational studies, 1 secondary analysis of a randomized controlled trial, 1 case-control study) with 16,112 participants']",['Labor neuraxial analgesia and breastfeeding'],"['breastfeeding rates', 'incidence of breastfeeding', 'breastfeeding rate']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007328', 'cui_str': 'Case Control Studies'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",16112.0,0.0676764,"Overall, there were 6 studies that found no difference between groups, 6 studies that showed a significantly lower incidence of breastfeeding in the neuraxial group and 3 studies finding mixed results (at some time-points statistically significant and at some time-point statistically non-significant results).","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Heesen', 'Affiliation': 'Faculty of Medicine, University of Zurich, Winterthurerstrasse 190, 8057 Zurich, Switzerland. Electronic address: heesenphilip99@gmail.com.'}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Halpern', 'Affiliation': 'Department of Anesthesia, University of Toronto and Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada. Electronic address: stephen.halpern@sunnybrook.ca.'}, {'ForeName': 'Yaakov', 'Initials': 'Y', 'LastName': 'Beilin', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, and Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, 1468 Madison Avenue, New York, NY 10029, USA. Electronic address: yaakov.beilin@mountsinai.org.'}, {'ForeName': 'Paola A', 'Initials': 'PA', 'LastName': 'Mauri', 'Affiliation': ""School of Midwifery, Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Via della Commenda 19, 20122 Milano, Italy; Department of Mother Child and Newborn Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Italy. Electronic address: paola.mauri@unimi.it.""}, {'ForeName': 'Leonid A', 'Initials': 'LA', 'LastName': 'Eidelman', 'Affiliation': 'Department of Anesthesia, Rabin Medical Center, Beilinson Hospital, Zeev Jabutinskiy Rd 39, Petah Tikva 49100, Israel. Electronic address: leidelman@clalit.org.il.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heesen', 'Affiliation': 'Department of Anesthesia, Kantonsspital Baden, Im Ergel 1, 5404 Baden, Switzerland. Electronic address: michael.heesen@ksb.ch.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Orbach-Zinger', 'Affiliation': 'Department of Anesthesia, Rabin Medical Center, Beilinson Hospital, Zeev Jabutinskiy Rd 39, Petah Tikva 49100, Israel. Electronic address: sharonorbach@yahoo.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110105']
1280,33069972,Efficacy of prothrombin complex concentrate for reversal of major bleeding due to rivaroxaban: A pilot randomized controlled trial.,,2020,,[],"['rivaroxaban', 'prothrombin complex concentrate']",[],[],"[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C4048712', 'cui_str': 'factor IX complex'}]",[],,0.158675,,"[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Shadvar', 'Affiliation': 'Department of Anesthesiology and intensive care medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Pariya', 'Initials': 'P', 'LastName': 'Sadaghi', 'Affiliation': 'Department of Anesthesiology and intensive care medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Hamishekar', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Mahmoodpoor', 'Affiliation': 'Department of Anesthesiology and intensive care medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: amahmoodpoor@yahoo.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110093']
1281,33076952,A comparison of the effects and usability of two exoskeletal robots with and without robotic actuation for upper extremity rehabilitation among patients with stroke: a single-blinded randomised controlled pilot study.,"BACKGROUND
Robotic rehabilitation of stroke survivors with upper extremity dysfunction may yield different outcomes depending on the robot type. Considering that excessive dependence on assistive force by robotic actuators may interfere with the patient's active learning and participation, we hypothesised that the use of an active-assistive robot with robotic actuators does not lead to a more meaningful difference with respect to upper extremity rehabilitation than the use of a passive robot without robotic actuators. Accordingly, we aimed to evaluate the differences in the clinical and kinematic outcomes between active-assistive and passive robotic rehabilitation among stroke survivors.
METHODS
In this single-blinded randomised controlled pilot trial, we assigned 20 stroke survivors with upper extremity dysfunction (Medical Research Council scale score, 3 or 4) to the active-assistive robotic intervention (ACT) and passive robotic intervention (PSV) groups in a 1:1 ratio and administered 20 sessions of 30-min robotic intervention (5 days/week, 4 weeks). The primary (Wolf Motor Function Test [WMFT]-score and -time: measures activity), and secondary (Fugl-Meyer Assessment [FMA] and Stroke Impact Scale [SIS] scores: measure impairment and participation, respectively; kinematic outcomes) outcome measures were determined at baseline, after 2 and 4 weeks of the intervention, and 4 weeks after the end of the intervention. Furthermore, we evaluated the usability of the robots through interviews with patients, therapists, and physiatrists.
RESULTS
In both the groups, the WMFT-score and -time improved over the course of the intervention. Time had a significant effect on the WMFT-score and -time, FMA-UE, FMA-prox, and SIS-strength; group × time interaction had a significant effect on SIS-function and SIS-social participation (all, p < 0.05). The PSV group showed better improvement in participation and smoothness than the ACT group. In contrast, the ACT group exhibited better improvement in mean speed.
CONCLUSIONS
There were no differences between the two groups regarding the impairment and activity domains. However, the PSV robots were more beneficial than ACT robots regarding participation and smoothness. Considering the high cost and complexity of ACT robots, PSV robots might be more suitable for rehabilitation in stroke survivors capable of voluntary movement. Trial registration The trial was registered retrospectively on 14 March 2018 at ClinicalTrials.gov (NCT03465267).",2020,"Time had a significant effect on the WMFT-score and -time, FMA-UE, FMA-prox, and SIS-strength; group × time interaction had a significant effect on SIS-function and SIS-social participation (all, p < 0.05).","['stroke survivors with upper extremity dysfunction', '20 stroke survivors with upper extremity dysfunction (Medical Research Council scale score, 3 or 4) to the', 'patients with stroke']","['active-assistive robotic intervention (ACT) and passive robotic intervention (PSV) groups in a 1:1 ratio and administered 20 sessions of 30-min robotic intervention', 'exoskeletal robots with and without robotic actuation', 'active-assistive and passive robotic rehabilitation', 'ACT']","['WMFT]-score and -time: measures activity), and secondary (Fugl-Meyer Assessment [FMA] and Stroke Impact Scale [SIS] scores: measure impairment and participation, respectively; kinematic outcomes) outcome measures', 'WMFT-score and -time, FMA-UE, FMA-prox, and SIS-strength', 'SIS-function and SIS-social participation', 'mean speed', 'WMFT-score and -time']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1698635', 'cui_str': 'Upper extremity dysfunction'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C4319628', 'cui_str': 'Actuation'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",,0.113419,"Time had a significant effect on the WMFT-score and -time, FMA-UE, FMA-prox, and SIS-strength; group × time interaction had a significant effect on SIS-function and SIS-social participation (all, p < 0.05).","[{'ForeName': 'Jin Ho', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, 58, Samgaksan-ro, Gangbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Gyulee', 'Initials': 'G', 'LastName': 'Park', 'Affiliation': 'Translational Research Program for Rehabilitation Robots, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Ha Yeon', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Translational Research Program for Rehabilitation Robots, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Yeong', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, 58, Samgaksan-ro, Gangbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Yeajin', 'Initials': 'Y', 'LastName': 'Ham', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, 58, Samgaksan-ro, Gangbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Donghwan', 'Initials': 'D', 'LastName': 'Hwang', 'Affiliation': 'Translational Research Program for Rehabilitation Robots, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Suncheol', 'Initials': 'S', 'LastName': 'Kwon', 'Affiliation': 'Translational Research Program for Rehabilitation Robots, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Joon-Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, 58, Samgaksan-ro, Gangbuk-gu, Seoul, Republic of Korea. asfreelyas@gmail.com.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00763-6']
1282,33078435,The effect of daily aerobic cycling exercise on sleep quality during inpatient cannabis withdrawal: A randomised controlled trial.,"Sleep disturbance is a common symptom encountered by cannabis-dependent individuals abstaining from cannabis use. In the present study, we investigated the effect of daily aerobic cycling exercise versus control stretching on sleep quality during inpatient cannabis withdrawal in treatment-seeking dependent cannabis users. The protocol incorporated three consecutive phases: a 4-Day (4-Night) (at-home) 'Baseline' phase, a 6-Day (5-Night) 'Treatment' phase (within a 7-Day inpatient hospital stay) and a 3-Day (4-Night) (at-home) 'Post-Treatment' phase. Participants performed 35 min of monitored activity per day during the Treatment phase. The intervention group (n = 19) cycled at ~60% aerobic capacity (VO 2max ), while the control group (n = 12) performed a stretching routine. Objective sleep quality was measured nightly throughout the study using wrist actigraphy ratings of subjective sleep quality were also recorded during the Treatment phase. There were no group differences in sleep measures during the Baseline phase (all p > .05). Objective sleep onset latency increased from the Baseline to the Treatment phase in the control (stretching) group (p = .042). In contrast, the Cycling group exhibited improvements in sleep duration (p = .008) and sleep efficiency (p = .023) during the Treatment phase compared to the Baseline phase. Cycling also increased sleep duration (p = .005), decreased average wake bout (p = .040) and tended to increase sleep efficiency (p = .051) compared to stretching during the Treatment phase. Subjective sleep quality ratings did not differ between groups (p > .10). These preliminary findings suggest that moderate-intensity aerobic exercise may attenuate the sleep disturbances associated with cannabis withdrawal.",2020,"Cycling also increased sleep duration (p = .005), decreased average wake bout (p = .040) and tended to increase sleep efficiency (p = .051) compared to stretching during the Treatment phase.","['inpatient cannabis withdrawal in treatment-seeking dependent cannabis users', 'inpatient cannabis withdrawal']","['daily aerobic cycling exercise versus control stretching', 'intervention group (n\xa0=\xa019) cycled at ~60% aerobic capacity (VO 2max ), while the control group (n\xa0=\xa012) performed a stretching routine', 'daily aerobic cycling exercise']","['sleep efficiency', 'Subjective sleep quality ratings', 'subjective sleep quality', 'average wake bout', 'sleep measures', 'sleep duration', 'sleep disturbances', 'Sleep disturbance', 'Objective sleep onset latency', 'sleep quality', 'Objective sleep quality']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C3840212', 'cui_str': 'Cannabis withdrawal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}]",,0.0265146,"Cycling also increased sleep duration (p = .005), decreased average wake bout (p = .040) and tended to increase sleep efficiency (p = .051) compared to stretching during the Treatment phase.","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McCartney', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Ashling D', 'Initials': 'AD', 'LastName': 'Isik', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kieron', 'Initials': 'K', 'LastName': 'Rooney', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Exercise and Sport Science, Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jonathon C', 'Initials': 'JC', 'LastName': 'Arnold', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Delwyn J', 'Initials': 'DJ', 'LastName': 'Bartlett', 'Affiliation': 'Woolcock Institute of Medical Research, Glebe, NSW, Australia.'}, {'ForeName': 'Bridin', 'Initials': 'B', 'LastName': 'Murnion', 'Affiliation': 'Drug and Alcohol Services, Central Coast Local Health District, Gosford, NSW, Australia.'}, {'ForeName': 'Elisha', 'Initials': 'E', 'LastName': 'Richards', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Arkell', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Addiction Medicine, Central Clinical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Iain S', 'Initials': 'IS', 'LastName': 'McGregor', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, NSW, Australia.'}]",Journal of sleep research,['10.1111/jsr.13211']
1283,33075067,"Anthelminthic treatment receipt and its predictors in Lake Victoria fishing communities, Uganda: Intervention coverage results from the LaVIISWA cluster randomised trial.","BACKGROUND
Mass drug administration (MDA) is a cornerstone of control of parasitic helminths. In schistosomiasis-endemic areas with >50% of school-aged children infected, community-wide MDA with praziquantel is recommended by the World Health Organisation (WHO), with target coverage of >75%. Using data from a cluster-randomised trial of MDA treatment strategies, we aimed to describe the proportion of eligible residents who received MDA and predictors of treatment receipt, and to assess associations with helminth prevalence.
METHODS
In the Koome islands of Lake Victoria, Uganda, where baseline schistosomiasis prevalence (by single stool sample, Kato Katz) was 52% overall (all ages) and 67% among school-aged children, we conducted a cluster-randomised trial of community-wide, intensive MDA (quarterly single-dose praziquantel 40mg/kg; triple-dose albendazole 400mg) versus standard, Uganda government intervention (annual single-dose praziquantel 40mg/kg; 6-monthly single-dose albendazole). Twenty-six fishing villages were randomised, 13 per trial arm, for four years. At each treatment round, praziquantel treatment and the first dose of albendazole treatment were directly observed by the study team, registers of village residents were updated and the proportion receiving treatment among those eligible recorded.
RESULTS
During the four-year MDA, at each treatment round an average of 13,382 people were registered in the 26 villages (7,153 and 6,229 in standard and intensive intervention villages, respectively). Overall, the proportion of those eligible receiving praziquantel was lower than for albendazole (60% versus 65%), particularly in the standard arm (61% versus 71%) compared to the intensive arm (60% versus 62%). Albendazole receipt was lower when given concurrently with praziquantel. Absence was the commonest reason for non-receipt of treatment (81% albendazole, 77% praziquantel), followed by refusal (14% albendazole, 18% praziquantel). Proportions receiving treatment were lowest among school-aged children, but did not differ by sex. Longitudinal analysis of a subgroup of residents who did not move during the study period found that persistent non-receipt of treatment in this subgroup was rare. Refusal to receive treatment was highest among adults and more common among females.
CONCLUSION
In schistosomiasis high-risk communities, a combination of approaches to increasing treatment coverage, such as extended periods of treatment delivery, and the provision of incentives, may be required to achieve WHO targets.",2020,"Absence was the commonest reason for non-receipt of treatment (81% albendazole, 77% praziquantel), followed by refusal (14% albendazole, 18% praziquantel).","['Twenty-six fishing villages', '13,382 people were registered in the 26 villages (7,153 and 6,229 in standard and intensive intervention villages, respectively']","['MDA', 'Albendazole', 'albendazole, 18% praziquantel', 'albendazole 400mg) versus standard, Uganda government intervention (annual single-dose praziquantel 40mg/kg; 6-monthly single-dose albendazole', 'albendazole', 'praziquantel']",[],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],,0.133095,"Absence was the commonest reason for non-receipt of treatment (81% albendazole, 77% praziquantel), followed by refusal (14% albendazole, 18% praziquantel).","[{'ForeName': 'Hellen', 'Initials': 'H', 'LastName': 'Akurut', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Sanya', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lubyayi', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Nampijja', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Kizza', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kaweesa', 'Affiliation': 'Vector Control Division, Uganda Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kizindo', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Sewankambo', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Nsubuga', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Edridah', 'Initials': 'E', 'LastName': 'Tukahebwa', 'Affiliation': 'Vector Control Division, Uganda Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Narcis B', 'Initials': 'NB', 'LastName': 'Kabatereine', 'Affiliation': 'Vector Control Division, Uganda Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Elliott', 'Affiliation': 'Immunomodulation and Vaccines Programme, MRC/UVRI and LSHTM Uganda Research Unit Entebbe, Uganda.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008718']
1284,33075159,Drug treatments for managing cystic fibrosis-related diabetes.,"BACKGROUND
The Cystic Fibrosis Foundation recommends both short-term and long-acting insulin therapy when cystic fibrosis-related diabetes (CFRD) has been diagnosed. Diagnosis is based on: an elevated fasting blood glucose level greater than 6.94 mmol/L (125 mg/dL); or oral glucose tolerance tests greater than 11.11 mmol/L (200 mg/dL) at two hours; or symptomatic diabetes for random glucose levels greater than 11.11 mmol/L (200 mg/dL); or glycated hemoglobin levels of at least 6.5%. This is an update of a previously published review.
OBJECTIVES
To establish the effectiveness of insulin and oral agents for managing diabetes in people with cystic fibrosis in relation to blood sugar levels, lung function and weight management.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also handsearched abstracts from pulmonary symposia and the North American Cystic Fibrosis Conferences. Date of most recent register search: 10 September 2020. We searched online trials registries; date of most recent searches: 21 March 2020.
SELECTION CRITERIA
Randomized controlled trials comparing all methods of pharmacological diabetes therapy in people with diagnosed CFRD.
DATA COLLECTION AND ANALYSIS
Two authors independently extracted data and assessed the risk of bias in the included studies. Authors also used GRADE to assess the quality of the evidence.
MAIN RESULTS
The searches identified 29 trials (45 references). Four included trials provide results: one short-term single-center cross-over trial (seven adults) comparing insulin with oral repaglinide and no medication in adults with CFRD and normal fasting glucose; one long-term multicenter trial (61 adults with CFRD) comparing insulin with oral repaglinide and placebo; one long-term multicenter trial (67 adults) comparing insulin with oral repaglinide; and one 12-week single-center cross-over trial (20 adults) comparing the long-acting insulin glargine to short-term neutral protamine Hagedorn insulin. Two ongoing trials of newly approved incretin mimics have been noted for possible future inclusion. Downgrading of the quality of the evidence was mainly due to risks of bias across all domains, but particularly due to concerns surrounding allocation concealment and selective reporting. There were also some concerns due to imprecision from small sample sizes and low event rates. Finally, there may be some bias due to the amounts of insulin and repaglinide given not being comparable. Data from one trial comparing insulin to placebo (39 participants) did not show any difference between groups for the primary outcomes of blood glucose levels (very low-quality evidence), lung function (low-quality evidence) or nutritional status (low-quality evidence). Similarly, no differences between groups were seen for the secondary outcomes of number of hypoglycemic episodes (low-quality evidence), secondary infection complications or quality of life (QoL). These results were mirrored in the narrative reports for the second trial in this comparison (seven participants). Data from the one-year trial comparing repaglinide to placebo (38 participants), showed no differences between groups for the primary outcomes of blood glucose levels (very low-quality evidence), lung function (low-quality evidence) and nutritional status (low-quality evidence). Also, no differences were seen between groups for the secondary outcomes of number of hypoglycemic episodes (low-quality evidence), secondary infection complications or QoL. These findings were mirrored in the narrative reports for the second trial (n = 7) in this comparison. Three trials compared insulin to repaglinide (119 participants). Data from one trial (n = 67) showed no difference in blood glucose levels at either 12 months (high-quality evidence) or 24 months; narrative reports from one trial (45 participants) reported no difference between groups, but the second trial (7 participants) reported a beneficial effect of insulin over repaglinide. Two trials (112 participants) found no difference between insulin and repaglinide in lung function or nutritional status (moderate-quality evidence). Two trials (56 participants) reported no difference in the number of hypoglycemic episodes (low-quality evidence). One trial (45 participants) reported no difference between groups in secondary infections and cystic fibrosis QoL. The single trial comparing glargine to neutral protamine Hagedorn insulin did not report directly on the review's primary outcomes, but did report no differences between groups in post-prandial glucose values and weight; neither group reported infectious complications. There was no difference in episodes of hypoglycemia (very low-quality evidence) and while there was no difference reported in QoL, all participants opted to continue treatment with glargine after the trial was completed. Mortality was not reported by any trial in any comparison, but death was not given as a reason for withdrawal in any trial.
AUTHORS' CONCLUSIONS
This review has not found any conclusive evidence that any agent has a distinct advantage over another in controlling hyperglycemia or the clinical outcomes associated with CFRD. Given the treatment burden already experienced by people with cystic fibrosis, oral therapy may be a viable treatment option. While some cystic fibrosis centers use oral medications to help control diabetes, the Cystic Fibrosis Foundation (USA) clinical practice guidelines support the use of insulin therapy and this remains the most widely-used treatment method. Randomized controlled trials specifically related to controlling diabetes and its impact on the course of pulmonary disease process in cystic fibrosis continue to be a high priority. Specifically, investigators should evaluate adherence to different therapies and also whether there is benefit in using additional hypoglycemic agents as well as the newly approved incretin mimics. Agents that potentiate insulin action, especially agents with additional anti-inflammatory potential should also be further investigated as adjuvant therapy to insulin.",2020,"Data from one trial comparing insulin to placebo (39 participants) did not show any difference between groups for the primary outcomes of blood glucose levels (very low-quality evidence), lung function (low-quality evidence) or nutritional status (low-quality evidence).","['people with diagnosed CFRD', '119 participants', 'in adults with CFRD and normal fasting glucose; one long-term multicenter trial (61 adults with CFRD) comparing', 'people with cystic fibrosis', 'managing cystic fibrosis-related diabetes', 'cystic fibrosis-related diabetes (CFRD']","['glargine', 'insulin and oral agents', 'insulin with oral repaglinide', 'pharmacological diabetes therapy', 'repaglinide', 'insulin with oral repaglinide and no medication', 'insulin with oral repaglinide and placebo', 'placebo', 'insulin and repaglinide', 'long-acting insulin glargine to short-term neutral protamine Hagedorn insulin', 'repaglinide to placebo']","['blood glucose levels (very low-quality evidence), lung function (low-quality evidence) and nutritional status (low-quality evidence', 'infectious complications', 'Mortality', 'number of hypoglycemic episodes (low-quality evidence), secondary infection complications or QoL', 'glycated hemoglobin levels', 'episodes of hypoglycemia', 'blood glucose levels', 'elevated fasting blood glucose level', 'blood glucose levels (very low-quality evidence), lung function (low-quality evidence) or nutritional status (low-quality evidence', 'beneficial effect of insulin over repaglinide', 'lung function or nutritional status (moderate-quality evidence', 'number of hypoglycemic episodes (low-quality evidence', 'secondary infections and cystic fibrosis QoL', 'oral glucose tolerance tests', 'number of hypoglycemic episodes (low-quality evidence), secondary infection complications or quality of life (QoL']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2242728', 'cui_str': 'Cystic fibrosis related diabetes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0304870', 'cui_str': 'Long-acting insulin'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021658', 'cui_str': 'insulin, isophane'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0442886', 'cui_str': 'Secondary infection'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",61.0,0.164958,"Data from one trial comparing insulin to placebo (39 participants) did not show any difference between groups for the primary outcomes of blood glucose levels (very low-quality evidence), lung function (low-quality evidence) or nutritional status (low-quality evidence).","[{'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Onady', 'Affiliation': 'Boonshoft School of Medicine, Wright State University, Dayton, Ohio, USA.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Stolfi', 'Affiliation': ""Department of Pediatrics, Children's Medical Center, Dayton, Ohio, USA.""}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004730.pub5']
1285,33075711,The effect of dry needling on gastrocnemius muscle stiffness and strength in participants with latent trigger points.,"Abnormal muscle stiffness is a potential complication after injury and identifying interventions that modify muscle stiffness may be useful to promote recovery. The purpose of this study was to identify the short-term effects of dry needling (DN) on resting and contracted gastrocnemius muscle stiffness and strength of the triceps surae in individuals with latent myofascial trigger points (MTrPs). In this randomized controlled trial, 52 individuals received two DN treatment sessions to latent MTrPs and 50 individuals received two sham needling sessions. Resting and contracted muscle stiffness were assessed both at the treatment site and a standardized central site in the medial gastrocnemius head immediately post-treatment and one week after the last session. There were significant group by time interactions for resting muscle stiffness at the site of the MTrP (p = .03), but not at the central site (p = .29). Post-needling between group comparison indicated that the DN group had significantly lower resting muscle stiffness at the site of the MTrP than the sham group after adjusting for baseline differences. There were no significant between group differences in contracted muscle stiffness or muscle strength. Identifying strategies that can reduce aberrant muscle stiffness may help to guide management of individuals with neuromuscular pain-related conditions. Level of evidence: Therapy, level 2.",2020,"There were significant group by time interactions for resting muscle stiffness at the site of the MTrP (p = .03), but not at the central site (p = .29).","['participants with latent trigger points', '52 individuals received two DN treatment sessions to latent MTrPs and 50 individuals received two', 'individuals with latent myofascial trigger points (MTrPs', 'individuals with neuromuscular pain-related conditions']","['sham needling sessions', 'dry needling', 'dry needling (DN']","['resting muscle stiffness', 'contracted muscle stiffness or muscle strength', 'gastrocnemius muscle stiffness and strength', 'Level of evidence', 'Resting and contracted muscle stiffness', 'time interactions for resting muscle stiffness']","[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1405031', 'cui_str': 'Neuromuscular pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",52.0,0.067405,"There were significant group by time interactions for resting muscle stiffness at the site of the MTrP (p = .03), but not at the central site (p = .29).","[{'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Albin', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Koppenhaver', 'Affiliation': 'Baylor University Doctoral Program in Physical Therapy, Waco, TX, United States.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'MacDonald', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Capoccia', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ngo', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Phippen', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pineda', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wendlandt', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Hoffman', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2020.102479']
1286,33076273,Effect of New Zealand Blackcurrant Extract on Isometric Contraction-Induced Fatigue and Recovery: Potential Muscle-Fiber Specific Effects.,"New Zealand blackcurrant (NZBC) extract has shown performance-enhancing effects during cycling, running and sport climbing. We examined effects of NZBC extract on (1) voluntary and twitch force of the quadriceps femoris muscles during repeated isometric contraction-induced fatigue, (2) twitch force during recovery and (3) muscle fiber-specific effects. Familiarized recreationally active males (n = 12, age: 24 ± 5 yrs; height: 180 ± 5 cm; body mass: 89 ± 11 kg) performed sixteen, 5-s voluntary maximal isometric contractions (iMVC) separated by 3-s rest. Twitch force was recorded before, during the 3-s rests and 5-min recovery. Supplementation consisted of 7-days intake of NZBC extract (600 mg∙day -1 containing 210 mg anthocyanin) in a double-blind, randomized, placebo-controlled crossover design with a 14-days washout. NZBC extract allowed for greater force in the first quartile of the iMVCs. Twitch force at baseline was 12% higher with NZBC extract ( p = 0.05). However, there was no effect of NZBC for twitch force during the 16-iMVCs and recovery. Based on the maximum post-activation potentiation during the placebo 16-iMVCs, four subjects were classified of having a predominant type I or II muscle fiber typology. In type II, NZBC extract provided a trend for increased MVC force (~14%) in the first quartile and for type I in the fourth quartile (~10%). In type I, NZBC extract seemed to have higher twitch forces during the fatiguing exercise protocol and recovery, indicating increased fatigue resistance. New Zealand blackcurrant extract affects force during repeated maximal isometric contractions. Future work on mechanisms by NZBC extract for muscle fiber-specific fatigue-induced force responses is warranted.",2020,Twitch force at baseline was 12% higher with NZBC extract ( p = 0.05).,"['Familiarized recreationally active males (n = 12, age: 24 ± 5 yrs; height: 180 ± 5 cm; body mass: 89 ± 11 kg) performed sixteen']","['New Zealand blackcurrant (NZBC) extract', 'NZBC', 'placebo', 'NZBC extract', 'New Zealand Blackcurrant Extract', 'NZBC extract (600 mg∙day -1 containing 210 mg anthocyanin', '5-s voluntary maximal isometric contractions (iMVC) separated by 3-s rest']","['twitch forces', 'fatigue resistance', 'Twitch force', 'fatigue, (2) twitch force during recovery and (3) muscle fiber-specific effects', 'MVC force']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",4.0,0.172571,Twitch force at baseline was 12% higher with NZBC extract ( p = 0.05).,"[{'ForeName': 'Mark E T', 'Initials': 'MET', 'LastName': 'Willems', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Bradley', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Sam D', 'Initials': 'SD', 'LastName': 'Blacker', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Perkins', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}]","Sports (Basel, Switzerland)",['10.3390/sports8100135']
1287,33080411,The effect of dietary nitrate on exercise capacity in chronic kidney disease: a randomized controlled pilot study.,"BACKGROUND
Chronic Kidney Disease (CKD) patients exhibit a reduced exercise capacity that impacts quality of life. Dietary nitrate supplementation has been shown to have favorable effects on exercise capacity in disease populations by reducing the oxygen cost of exercise. This study investigated whether dietary nitrates would acutely improve exercise capacity in CKD patients.
METHODS AND RESULTS
In this randomized, double-blinded crossover study, 12 Stage 3-4 CKD patients (Mean ± SEM: Age, 60 ± 5yrs; eGFR, 50.3 ± 4.6 ml/min/1.73 m 2 ) received an acute dose of 12.6 mmol of dietary nitrate in the form of concentrated beetroot juice (BRJ) and a nitrate depleted placebo (PLA). Skeletal muscle mitochondrial oxidative function was assessed using near-infrared spectroscopy. Cardiopulmonary exercise testing was performed on a cycle ergometer, with intensity increased by 25 W every 3 min until volitional fatigue. Plasma nitric oxide (NO) metabolites (NOm; nitrate, nitrite, low molecular weight S-nitrosothiols, and metal bound NO) were determined by gas-phase chemiluminescence. Plasma NOm values were significantly increased following BRJ (BRJ vs. PLA: 1074.4 ± 120.4 μM vs. 28.4 ± 6.6 μM, p < 0.001). Total work performed (44.4 ± 10.6 vs 39.6 ± 9.9 kJ, p = 0.03) and total exercise time (674 ± 85 vs 627 ± 86s, p = 0.04) were significantly greater following BRJ. Oxygen consumption at the ventilatory threshold was also improved by BRJ (0.90 ± 0.08 vs. 0.74 ± 0.06 L/min, p = 0.04). These changes occurred in the absence of improved skeletal muscle mitochondrial oxidative capacity (p = 0.52) and VO 2peak (p = 0.35).
CONCLUSIONS
Our findings demonstrate that inorganic nitrate can acutely improve exercise capacity in CKD patients. The effects of chronic nitrate supplementation on CKD related exercise intolerance should be investigated in future studies.",2020,"These changes occurred in the absence of improved skeletal muscle mitochondrial oxidative capacity (p=0.52) and VO 2peak (p=0.35).
","['12 Stage 3-4 CKD patients (Mean±SEM: Age, 60 ± 5yrs; eGFR, 50.3 ± 4.6ml/min/1.73m 2 ) received an', 'Chronic Kidney Disease (CKD) patients', 'CKD patients', 'chronic kidney disease']","['chronic nitrate supplementation', 'dietary nitrate', 'acute dose of 12.6 mmol of dietary nitrate in the form of concentrated beetroot juice (BRJ) and a nitrate depleted placebo (PLA', 'BRJ (BRJ vs. PLA', 'dietary nitrates', 'Dietary nitrate supplementation', 'inorganic nitrate']","['total exercise time', 'Oxygen consumption', 'skeletal muscle mitochondrial oxidative capacity', 'Plasma NOm values', 'Plasma Nitric Oxide (NO) metabolites (NOm; nitrate, nitrite, low molecular weight S-nitrosothiols, and metal bound', 'exercise capacity', 'Skeletal muscle mitochondrial oxidative function']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0429931', 'cui_str': 'Total exercise time'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0141313', 'cui_str': 'S-Nitrosothiol'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.142506,"These changes occurred in the absence of improved skeletal muscle mitochondrial oxidative capacity (p=0.52) and VO 2peak (p=0.35).
","[{'ForeName': 'Meghan G', 'Initials': 'MG', 'LastName': 'Ramick', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA; Department of Kinesiology, West Chester University, West Chester, PA, USA.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Kirkman', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA; Department of Kinesiology and Health Sciences, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Stock', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Bryce J', 'Initials': 'BJ', 'LastName': 'Muth', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA; School of Health Sciences, Stockton University, Stockton, NJ, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Chirinos', 'Affiliation': 'Division of Cardiovascular Medicine. Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Paschalis-Thomas', 'Initials': 'PT', 'LastName': 'Doulias', 'Affiliation': ""Laboratory of Biochemistry, Department of Chemistry, School of Sciences, University of Ioannina, Ioannina, 45110, Greece; Children's Hospital of Philadelphia Research Institute, Philadelphia, PA, USA.""}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Ischiropoulos', 'Affiliation': ""Laboratory of Biochemistry, Department of Chemistry, School of Sciences, University of Ioannina, Ioannina, 45110, Greece; Children's Hospital of Philadelphia Research Institute, Philadelphia, PA, USA.""}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA. Electronic address: dge@udel.edu.'}]",Nitric oxide : biology and chemistry,['10.1016/j.niox.2020.10.002']
1288,33080415,Prevention of hypotension during elective cesarean section with a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion. Α double-blinded randomized controlled trial.,"BACKGROUND
Spinal anesthesia for cesarean section can be complicated by hypotension, with untoward effects for both the mother and fetus. Frequently used phenylephrine can lead to baroreceptor-mediated reflex bradycardia. The aim of the present study was to compare a fixed-rate prophylactic norepinephrine infusion to a fixed-rate prophylactic phenylephrine infusion during elective cesarean section under combined spinal-epidural anesthesia.
MATERIALS AND METHODS
Eighty-two parturients were randomized to either norepinephrine 4 μg/min or phenylephrine 50 μg/min fixed-rate infusions, starting simultaneously with the administration of the subarachnoid solution. The primary endpoint was the incidence of maternal bradycardia. Maternal hemodynamics at specific timepoints, the incidence of hypotension or hypertension, the requirement for ephedrine or atropine bolus administration as well as the acid-base status and Apgar score of the neonate were recorded.
RESULTS
The incidence of bradycardia as well as the requirement for atropine administration was lower in the norepinephrine group (4.8% vs. 31.7%, p = 0.004 and 2.4% vs. 24.3%, p = 0.01, respectively). Fetal pH, and fetal blood glucose concentration were higher in the norepinephrine group (p = 0.027 and 0.019, respectively). No difference in the occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores was demonstrated.
CONCLUSIONS
A fixed-rate infusion of norepinephrine is as effective in the management of hypotension during regional anesthesia for cesarean section as a fixed-rate infusion of phenylephrine, with the avoidance of phenylephrine-induced bradycardia. The more favourable neonatal acid-base profile of noradrenaline might be due to better maintenance of placental blood flow in the noradrenaline group due to its beta action, while the higher fetal glucose concentration in the same group might result from a catecholamine-stimulated glucose metabolism increase and a β-receptor mediated insulin decrease.",2020,"No difference in the occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores was demonstrated.
","['Eighty-two parturients', 'hypotension during elective cesarean section with a']","['norepinephrine', 'fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine', 'norepinephrine 4 μg/min or phenylephrine 50 μg/min fixed-rate infusions, starting simultaneously with the administration of the subarachnoid solution', 'phenylephrine', 'phenylephrine infusion']","['Maternal hemodynamics', 'incidence of hypotension or hypertension', 'incidence of bradycardia', 'occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores', 'fetal glucose concentration', 'Fetal pH, and fetal blood glucose concentration', 'incidence of maternal bradycardia', 'placental blood flow']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",82.0,0.245385,"No difference in the occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores was demonstrated.
","[{'ForeName': 'Kassiani', 'Initials': 'K', 'LastName': 'Theodoraki', 'Affiliation': '1st Department of Anesthesiology, Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece. Electronic address: ktheodoraki@hotmail.com.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Hadzilia', 'Affiliation': 'Department of Anesthesiology, Alexandra General Hospital of Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Valsamidis', 'Affiliation': 'Department of Anesthesiology, Alexandra General Hospital of Athens, Greece.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Stamatakis', 'Affiliation': 'Department of Anesthesiology, Alexandra General Hospital of Athens, Greece.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.10.006']
1289,33080924,The Effects of Strength and Conditioning in Physical Education on Athletic Motor Skill Competencies and Psychological Attributes of Secondary School Children: A Pilot Study.,"Leading global physical activity guidelines advocate that young children need to engage in activities that strengthen musculoskeletal tissues and improve movement skill competency. The purpose of this study was to examine the effects of delivering strength and conditioning as part of the physical education curriculum on athletic motor skill competencies (AMSC), physical performance, and psychosocial factors. Forty-six school children aged 11-14 were included in the study, and sub-divided firstly by sex and then into intervention and control groups. Intervention groups received nine lessons of strength and conditioning based activities over a six-week period, while the control groups continued with traditional physical education curricula. The resistance training skills battery (RTSB) and tuck jump assessment (TJA) assessed AMSC. Standing long jump distance assessed lower limb strength, and online surveys examined motivation, physical self-efficacy and self-esteem. Male and female intervention groups significantly improved RTSB ( p > 0.05) whereas no changes were observed in the control groups. No changes were observed in the intervention groups TJA and only trivial and small non-significant changes in standing long jump performance. Significant increases in motivation of the male intervention group occurred. Strength and conditioning integrated in physical education can improve AMSC in short-term interventions.",2020,No changes were observed in the intervention groups TJA and only trivial and small non-significant changes in standing long jump performance.,"['young children', 'Forty-six school children aged 11-14 were included in the study, and sub-divided firstly by sex and then into intervention and control groups', 'Secondary School Children']","['Strength and Conditioning in Physical Education', 'nine lessons of strength and conditioning based activities over a six-week period, while the control groups continued with traditional physical education curricula']","['Standing long jump distance assessed lower limb strength, and online surveys examined motivation, physical self-efficacy and self-esteem', 'standing long jump performance', 'resistance training skills battery (RTSB) and tuck jump assessment (TJA) assessed AMSC', 'motivation', 'RTSB', 'athletic motor skill competencies (AMSC), physical performance, and psychosocial factors']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1279901', 'cui_str': 'Firstly'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}]",46.0,0.013785,No changes were observed in the intervention groups TJA and only trivial and small non-significant changes in standing long jump performance.,"[{'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Pullen', 'Affiliation': 'Youth Physical Development Centre, Cardiff Metropolitan University, Cyncoed Campus, Cardiff CF23 6XB, Wales, UK.'}, {'ForeName': 'Jon L', 'Initials': 'JL', 'LastName': 'Oliver', 'Affiliation': 'Youth Physical Development Centre, Cardiff Metropolitan University, Cyncoed Campus, Cardiff CF23 6XB, Wales, UK.'}, {'ForeName': 'Rhodri S', 'Initials': 'RS', 'LastName': 'Lloyd', 'Affiliation': 'Youth Physical Development Centre, Cardiff Metropolitan University, Cyncoed Campus, Cardiff CF23 6XB, Wales, UK.'}, {'ForeName': 'Camilla J', 'Initials': 'CJ', 'LastName': 'Knight', 'Affiliation': 'Welsh Institute of Performance Science, Sport Wales, Sophia Gardens, Cardiff CF11 9SW, Wales, UK.'}]","Sports (Basel, Switzerland)",['10.3390/sports8100138']
1290,33081069,"Effectiveness of a Multicomponent Treatment for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): A Pragmatic Randomized Controlled Trial.","A recent study (FIBROWALK has supported the effectiveness of a multicomponent treatment based on pain neuroscience education (PNE), exercise therapy (TE), cognitive behavioral therapy (CBT), and mindfulness in patients with fibromyalgia. The aim of the present RCT was: (a) to analyze the effectiveness of a 12-week multicomponent treatment (nature activity therapy for fibromyalgia, NAT-FM) based on the same therapeutic components described above plus nature exposure to maximize improvements in functional impairment (primary outcome), as well as pain, fatigue, anxiety-depression, physical functioning, positive and negative affect, self-esteem, and perceived stress (secondary outcomes), and kinesiophobia, pain catastrophizing thoughts, personal perceived competence, and cognitive emotion regulation (process variables) compared with treatment as usual (TAU); (b) to preliminarily assess the effects of the nature-based activities included (yoga, Nordic walking, nature photography, and Shinrin Yoku); and (c) to examine whether the positive effects of TAU + NAT-FM on primary and secondary outcomes at post-treatment were mediated through baseline to six-week changes in process variables. A total of 169 FM patients were randomized into two study arms: TAU + NAT-FM vs. TAU alone. Data were collected at baseline, at six-week of treatment, at post-treatment, and throughout treatment by ecological momentary assessment (EMA). Using an intention to treat (ITT) approach, linear mixed-effects models and mediational models through path analyses were computed. Overall, TAU + NAT-FM was significantly more effective than TAU at posttreatment for the primary and secondary outcomes evaluated, as well as for the process variables. Moderate-to-large effect sizes were achieved at six-weeks for functional impairment, anxiety, kinesiophobia, perceived competence, and positive reappraisal. The number needed to treat (NNT) was 3 (95%CI = 1.6-3.2). The nature activities yielded an improvement in affective valence, arousal, dominance, fatigue, pain, stress, and self-efficacy. Kinesiophobia and perceived competence were the mediators that could explain a significant part of the improvements obtained with TAU + NAT-FM treatment. TAU + NAT-FM is an effective co-adjuvant multicomponent treatment for improving FM-related symptoms.",2020,"Moderate-to-large effect sizes were achieved at six-weeks for functional impairment, anxiety, kinesiophobia, perceived competence, and positive reappraisal.","['169 FM patients', 'patients with fibromyalgia']","['Multicomponent Treatment', 'exercise therapy (TE), cognitive behavioral therapy (CBT', 'multicomponent treatment (nature activity therapy', 'TAU + NAT-FM vs. TAU alone', 'TAU + NAT-FM']","['Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM', 'pain, fatigue, anxiety-depression, physical functioning, positive and negative affect, self-esteem, and perceived stress (secondary outcomes), and kinesiophobia, pain catastrophizing thoughts, personal perceived competence, and cognitive emotion regulation (process variables', 'number needed to treat (NNT', 'affective valence, arousal, dominance, fatigue, pain, stress, and self-efficacy', 'usual (TAU']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0150123', 'cui_str': 'Activity care'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0067787', 'cui_str': 'N-acetyltalosaminuronic acid'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0067787', 'cui_str': 'N-acetyltalosaminuronic acid'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]",169.0,0.0817792,"Moderate-to-large effect sizes were achieved at six-weeks for functional impairment, anxiety, kinesiophobia, perceived competence, and positive reappraisal.","[{'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Serrat', 'Affiliation': ""Unitat d'Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain.""}, {'ForeName': 'Míriam', 'Initials': 'M', 'LastName': 'Almirall', 'Affiliation': ""Unitat d'Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Musté', 'Affiliation': ""Unitat d'Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain.""}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Sanabria-Mazo', 'Affiliation': ""Stress and Health Research Group, Departament de Psicologia Bàsica, Evolutiva i de l'Educació, Universitat Autònoma de Barcelona, 08193 Bellaterra, Spain.""}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Feliu-Soler', 'Affiliation': ""Stress and Health Research Group, Departament de Psicologia Bàsica, Evolutiva i de l'Educació, Universitat Autònoma de Barcelona, 08193 Bellaterra, Spain.""}, {'ForeName': 'Jorge L', 'Initials': 'JL', 'LastName': 'Méndez-Ulrich', 'Affiliation': 'Research Group on Socioeducative Interventions in Childhood and Youth (GRISIJ), Department of Methods of Research and Diagnosis in Education, Faculty on Education, University of Barcelona, 08007 Barcelona, Spain.'}, {'ForeName': 'Juan V', 'Initials': 'JV', 'LastName': 'Luciano', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Catalonia, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Sanz', 'Affiliation': ""Stress and Health Research Group, Departament de Psicologia Bàsica, Evolutiva i de l'Educació, Universitat Autònoma de Barcelona, 08193 Bellaterra, Spain.""}]",Journal of clinical medicine,['10.3390/jcm9103348']
1291,33082244,"Effects of Low-Fat, Mediterranean, or Low-Carbohydrate Weight Loss Diets on Serum Urate and Cardiometabolic Risk Factors: A Secondary Analysis of the Dietary Intervention Randomized Controlled Trial (DIRECT).","OBJECTIVE
Weight loss diets may reduce serum urate (SU) by lowering insulin resistance while providing cardiometabolic benefits, something urate-lowering drugs have not shown in trials. We aimed to examine the effects of weight loss diets on SU and cardiometabolic risk factors.
RESEARCH DESIGN AND METHODS
This secondary study of the Dietary Intervention Randomized Controlled Trial (DIRECT) used stored samples from 235 participants with moderate obesity randomly assigned to low-fat, restricted-calorie ( n = 85); Mediterranean, restricted-calorie ( n = 76); or low-carbohydrate, non-restricted-calorie ( n = 74) diets. We examined SU changes at 6 and 24 months overall and among those with hyperuricemia (SU ≥416 μmol/L), a relevant subgroup at risk for gout.
RESULTS
Among all participants, average SU decreases were 48 μmol/L at 6 months and 18 μmol/L at 24 months, with no differences between diets ( P > 0.05). Body weight, HDL cholesterol (HDL-C), total cholesterol:HDL-C ratio, triglycerides, and insulin concentrations also improved in all three groups ( P < 0.05 at 6 months). Adjusting for covariates, changes in weight and fasting plasma insulin concentrations remained associated with SU changes ( P < 0.05). SU reductions among those with hyperuricemia were 113, 119, and 143 μmol/L at 6 months for low-fat, Mediterranean, and low-carbohydrate diets (all P for within-group comparison < 0.001; P > 0.05 for between-group comparisons) and 65, 77, and 83 μmol/L, respectively, at 24 months (all P for within-group comparison < 0.01; P > 0.05 for between-group comparisons).
CONCLUSIONS
Nonpurine-focused weight loss diets may simultaneously improve SU and cardiovascular risk factors likely mediated by reducing adiposity and insulin resistance. These dietary options could provide personalized pathways to suit patient comorbidity and preferences for adherence.",2020,"Adjusting for covariates, changes in weight and fasting plasma insulin concentrations remained associated with SU changes ( P < 0.05).","['235 participants with moderate obesity randomly assigned to low-fat, restricted-calorie ( n = 85']","['Mediterranean, restricted-calorie ( n = 76); or low-carbohydrate, non-restricted-calorie ( n = 74) diets', 'weight loss diets', 'Low-Fat, Mediterranean, or Low-Carbohydrate Weight Loss Diets']","['adiposity and insulin resistance', 'weight and fasting plasma insulin concentrations', 'Serum Urate and Cardiometabolic Risk Factors', 'Body weight, HDL cholesterol (HDL-C), total cholesterol:HDL-C ratio, triglycerides, and insulin concentrations', 'average SU decreases', 'SU reductions']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",235.0,0.0512083,"Adjusting for covariates, changes in weight and fasting plasma insulin concentrations remained associated with SU changes ( P < 0.05).","[{'ForeName': 'Chio', 'Initials': 'C', 'LastName': 'Yokose', 'Affiliation': 'Clinical Epidemiology Program, Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'McCormick', 'Affiliation': 'Clinical Epidemiology Program, Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Sharan K', 'Initials': 'SK', 'LastName': 'Rai', 'Affiliation': 'Arthritis Research Canada, Richmond, British Columbia, Canada.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Lu', 'Affiliation': 'Arthritis Research Canada, Richmond, British Columbia, Canada.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Curhan', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Schwarzfuchs', 'Affiliation': 'Department of Emergency Medicine, Soroka University Medical Center, and Faculty of Health, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'S. Daniel Abraham Center for Health and Nutrition, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Hyon K', 'Initials': 'HK', 'LastName': 'Choi', 'Affiliation': 'Clinical Epidemiology Program, Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Boston, MA hchoi@mgh.harvard.edu.'}]",Diabetes care,['10.2337/dc20-1002']
1292,33093783,The effect of the walk-bike on quality of life and exercise capacity in patients with idiopathic pulmonary fibrosis: a feasibility study.,"Idiopathic pulmonary fibrosis (IPF) is characterized by progressive loss of pulmonary function and exercise capacity, leading to loss of quality of life and often social isolation. A new walking aid, the walk-bike, showed an improvement in exercise performance in COPD patients. Aims of this pilot study were to evaluate feasibility of a homebased walk-bike intervention study in IPF patients and to explore the effect of the walk-bike on quality of life (QoL) and exercise capacity. Twenty-three patients with IPF were included in a randomized multicenter crossover study with 8 weeks of standard care and 8 weeks of walk-bike use at home. Ten patients completed both study phases. Study barriers included reluctance to participate and external factors (e.g. weather and road conditions) that hampered adherence. Patients' satisfaction and experience with the walk-bike varied greatly. After training with the walk-bike, health-related QoL (St. George's Respiratory and King's Brief Interstitial Lung Disease questionnaires) demonstrated a tendency towards improvement, exercise capacity did not. A clinically important difference was found between 6-minute walk test with the walk-bike and the standard test; median (range) respectively 602 m (358-684) and 486 m (382-510). Conclusions: Due to practical barriers a larger study with the walk-bike in patients with IPF seems not feasible. Individual patients may benefit from the use of a walk-bike as it improved action radius and showed a tendency towards improvement in QoL. No effect on exercise capacity was observed. (Sarcoidosis Vasc Diffuse Lung Dis 2020; 37 (2): 192-202) .",2020,A clinically important difference was found between 6-minute walk test with the walk-bike and the standard test; median (range) respectively 602 m (358-684) and 486 m (382-510).,"['Twenty-three patients with IPF', 'patients with idiopathic pulmonary fibrosis', 'COPD patients', 'IPF patients', 'Idiopathic pulmonary fibrosis (IPF']","['homebased walk-bike intervention', 'walk-bike']","['exercise capacity', 'quality of life (QoL) and exercise capacity', 'exercise performance', 'quality of life and exercise capacity']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",23.0,0.0227786,A clinically important difference was found between 6-minute walk test with the walk-bike and the standard test; median (range) respectively 602 m (358-684) and 486 m (382-510).,"[{'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Wapenaar', 'Affiliation': 'Department of Respiratory Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bendstrup', 'Affiliation': 'Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Molina-Molina', 'Affiliation': 'ILD Unit, Hospital de Bellvitge-IDIBELL, University of Barcelona, Spain.'}, {'ForeName': 'Maarten K N', 'Initials': 'MKN', 'LastName': 'Stessel', 'Affiliation': 'Department of Respiratory Diseases, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Huremovic', 'Affiliation': 'Department of Respiratory Diseases, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Bakker', 'Affiliation': 'Division Clinical Methods and Public Health, Academic Medical Center, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Kardys', 'Affiliation': 'Department of Cardiology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Joachim G J V', 'Initials': 'JGJV', 'LastName': 'Aerts', 'Affiliation': 'Department of Respiratory Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Marlies S', 'Initials': 'MS', 'LastName': 'Wijsenbeek', 'Affiliation': 'Department of Respiratory Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.'}]","Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG",['10.36141/svdld.v37i2.9433']
1293,33095682,"Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance), a Neoadjuvant Phase III Trial of Paclitaxel-Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer.","PURPOSE
CALGB 40601 assessed whether dual versus single human epidermal growth factor receptor 2 (HER2) -targeting drugs added to neoadjuvant chemotherapy increased pathologic complete response (pCR). Here, we report relapse-free survival (RFS), overall survival (OS), and gene expression signatures that predict pCR and survival.
PATIENTS AND METHODS
Three hundred five women with untreated stage II and III HER2-positive breast cancer were randomly assigned to receive weekly paclitaxel combined with trastuzumab plus lapatinib (THL), trastuzumab (TH), or lapatinib (TL). The primary end point was pCR, and secondary end points included RFS, OS, and gene expression analyses. mRNA sequencing was performed on 264 pretreatment samples.
RESULTS
One hundred eighteen patients were randomly allocated to THL, 120 to TH, and 67 to TL. At more than 7 years of follow-up, THL had significantly better RFS and OS than did TH (RFS hazard ratio, 0.32; 95% CI, 0.14 to 0.71; P = .005; OS hazard ratio, 0.34; 95% CI, 0.12 to 0.94; P = .037), with no difference between TH and TL. Of 688 previously described gene expression signatures, significant associations were found in 215 with pCR, 45 with RFS, and only 22 with both pCR and RFS (3.2%). Specifically, eight immune signatures were significantly correlated with a higher pCR rate and better RFS. Among patients with residual disease, the immunoglobulin G signature was an independent, good prognostic factor, whereas the HER2-enriched signature, which was associated with a higher pCR rate, showed a significantly shorter RFS.
CONCLUSION
In CALGB 40601, dual HER2-targeting resulted in significant RFS and OS benefits. Integration of intrinsic subtype and immune signatures allowed for the prediction of pCR and RFS, both overall and within the residual disease group. These approaches may provide means for rational escalation and de-escalation treatment strategies in HER2-positive breast cancer.",2020,"OS hazard ratio, 0.34; 95% CI, 0.12 to 0.94; P = .037), with no difference between TH and TL.","['Three hundred five women with untreated stage II and III HER2-positive breast cancer', 'HER2-positive breast cancer', 'One hundred eighteen patients', 'HER2-Positive Breast Cancer']","['Paclitaxel-Trastuzumab With or Without Lapatinib', 'THL', 'paclitaxel combined with trastuzumab plus lapatinib (THL), trastuzumab (TH), or lapatinib (TL']","['relapse-free survival (RFS), overall survival (OS), and gene expression signatures that predict pCR and survival', 'pathologic complete response (pCR', 'pCR, and secondary end points included RFS, OS, and gene expression analyses', 'pCR rate', 'pCR rate and better RFS', 'RFS and OS', 'Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1956267', 'cui_str': 'Transcriptome Profiles'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0017428', 'cui_str': 'Genome'}]",305.0,0.0737803,"OS hazard ratio, 0.34; 95% CI, 0.12 to 0.94; P = .037), with no difference between TH and TL.","[{'ForeName': 'Aranzazu', 'Initials': 'A', 'LastName': 'Fernandez-Martinez', 'Affiliation': 'Lineberger Comprehensive Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Ian E', 'Initials': 'IE', 'LastName': 'Krop', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hillman', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Mei-Yin', 'Initials': 'MY', 'LastName': 'Polley', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Parker', 'Affiliation': 'Lineberger Comprehensive Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Huebner', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Hoadley', 'Affiliation': 'Lineberger Comprehensive Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shepherd', 'Affiliation': 'Lineberger Comprehensive Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Tolaney', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'N Lynn', 'Initials': 'NL', 'LastName': 'Henry', 'Affiliation': 'University of Michigan Rogel Cancer Center, Ann Arbor, MI.'}, {'ForeName': 'Chau', 'Initials': 'C', 'LastName': 'Dang', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Lyndsay', 'Initials': 'L', 'LastName': 'Harris', 'Affiliation': 'National Cancer Institute, Cancer Diagnostics Program, Bethesda, MD.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Berry', 'Affiliation': 'Division of Biostatistics, MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Olwen', 'Initials': 'O', 'LastName': 'Hahn', 'Affiliation': 'Alliance Protocol Operations Office, University of Chicago, Chicago, IL.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Hudis', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Winer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Partridge', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Perou', 'Affiliation': 'Lineberger Comprehensive Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': 'Lineberger Comprehensive Center, University of North Carolina, Chapel Hill, NC.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01276']
1294,33096333,Effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): Results of a pragmatic randomized controlled trial.,"BACKGROUND
Major Depressive Disorder (MDD) has a major impact on public health. Reduction of depression burden in general population is of greatest importance and might be achieved by implementation of depression prevention measures into routine care. We evaluate an online prevention measure as part of a national project aiming to reduce depression in the occupational group of green professions.
METHODS
This two-armed pragmatic RCT (n = 360) evaluates the effectiveness of a tailored internet-based intervention (IMI) program compared to enhanced treatment as usual. The IMI program entailed access to one of six guided IMIs each focusing on different symptom areas (depressive mood with optional comorbid diabetes, perceived stress, insomnia, panic and agoraphobia and harmful alcohol consumption). Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5). Primary outcome was depressive symptom severity (QIDS-SR16) at 9-weeks post-treatment (T1). Various secondary outcomes were assessed at T1.
RESULTS
A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033). Categorical analysis indicated a reduced risk of potential MDD with NNTB=28.11. Adherence to the IMI program at T1 was exceptionally low.
LIMITATIONS
Results are limited to green professions and representativeness might be restricted by self-selection of participants.
CONCLUSION
Depression burden in green professions can be reduced by this online prevention measure. Yet, short-term effectiveness is restricted by low adherence rates.
TRIAL REGISTRATION
German Clinical Trial Registration: DRKS00014000. Registered: 09 April 2018.",2020,"A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033).","['green professions (PROD-A', 'Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5', 'Major Depressive Disorder (MDD']","['guided internet-based interventions', 'tailored internet-based intervention (IMI) program']","['stress, insomnia, panic and agoraphobia and harmful alcohol consumption', 'risk of potential MDD', 'depressive symptom severity (QIDS-SR16', 'depression reduction']","[{'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0070319', 'cui_str': 'Cytochrome p450 CYP2B1 enzyme'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.107642,"A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033).","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Braun', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany. Electronic address: lina.braun@uni-ulm.de.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Titzler', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany; GET.ON Institute, Berlin, Germany.'}, {'ForeName': 'Yannik', 'Initials': 'Y', 'LastName': 'Terhorst', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany; Department of Research Methods, Institute of Psychology and Education, University of Ulm, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Freund', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Janika', 'Initials': 'J', 'LastName': 'Thielecke', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany; GET.ON Institute, Berlin, Germany; Department of Clinical, Neuro- & Developmental Psychology, VU University Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.066']
1295,33096356,"Adjunct high-frequency transcranial random noise stimulation over the lateral prefrontal cortex improves negative symptoms of schizophrenia: A randomized, double-blind, sham-controlled pilot study.","High-frequency transcranial random noise stimulation (hf-tRNS) is a non-invasive neuromodulatory technique capable of increasing human cortex excitability. There were only published case reports on the use of hf-tRNS targeting the lateral prefrontal cortex in treating negative symptoms of schizophrenia, thus necessitating systematic investigation. We designed a randomized, double-blind, sham-controlled trial in a cohort of stabilized schizophrenia patients to examine the efficacy of add-on hf-tRNS (100-640 Hz; 2 mA; 20 min) using a high definition 4 × 1 electrode montage (anode AF3, cathodes AF4, F2, F6, and FC4) in treating negative symptoms (ClinicalTrials.gov ID: NCT04038788). Participants received either active hf-tRNS or sham twice daily for 5 consecutive weekdays. Primary outcome measure was the change over time in the Positive and Negative Syndrome Scale Factor Score for Negative Symptoms (PANSS-FSNS), which was measured at baseline, after 10-session stimulation, and at one-week and one-month follow-ups. Among 36 randomized patients, 35 (97.2%) completed the trial. Intention-to-treat analysis showed a significantly greater decrease in PANSS-FSNS score after active (-17.11%) than after sham stimulation (-1.68%), with a large effect size (Cohen's d = 2.16, p < 0.001). The beneficial effect lasted for up to one month. In secondary-outcome analyses, the authors observed improvements with hf-tRNS of disorganization symptoms, unawareness of negative symptoms, subjective response to taking antipsychotics, and antipsychotic-induced extrapyramidal symptoms. No effects were observed on the neurocognitive performance and other outcome measures. Overall, hf-tRNS was safe and efficacious in improving negative symptoms. Our promising findings should be confirmed in a larger sample of patients with predominant negative symptoms.",2020,No effects were observed on the neurocognitive performance and other outcome measures.,"['stabilized schizophrenia patients', '36 randomized patients, 35 (97.2%) completed the trial', 'schizophrenia']","['High-frequency transcranial random noise stimulation (hf-tRNS', 'Adjunct high-frequency transcranial random noise stimulation', 'active hf-tRNS']","['PANSS-FSNS score', 'disorganization symptoms, unawareness of negative symptoms, subjective response to taking antipsychotics, and antipsychotic-induced extrapyramidal symptoms', 'change over time in the Positive and Negative Syndrome Scale Factor Score for Negative Symptoms (PANSS-FSNS', 'neurocognitive performance']","[{'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517910', 'cui_str': '97.2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0041657', 'cui_str': 'Loss of consciousness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",36.0,0.528973,No effects were observed on the neurocognitive performance and other outcome measures.,"[{'ForeName': 'Chuan-Chia', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Yen-Yue', 'Initials': 'YY', 'LastName': 'Lin', 'Affiliation': 'Department of Emergency Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Department of Emergency Medicine, Taoyuan Armed Forces General Hospital, Taoyuan, Taiwan; Department of Life Sciences, National Central University, Taoyuan, Taiwan.'}, {'ForeName': 'Nian-Sheng', 'Initials': 'NS', 'LastName': 'Tzeng', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chen', 'Initials': 'YC', 'LastName': 'Kao', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Department of Psychiatry, Tri-Service General Hospital Songshan Branch, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Hsin-An', 'Initials': 'HA', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan. Electronic address: chang.ha@mail.ndmctsgh.edu.tw.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.008']
1296,33096362,Simulation strategies to increase nursing student clinical competence in safe medication administration practices: A quasi-experimental study.,"BACKGROUND
Nursing student medication errors often result from deficits in knowledge and application of fundamental safe administration practices. Factors such as high faculty-student ratios and legal restrictions have decreased clinical learning opportunities for nursing students to practice safe medication administration in the clinical setting. Evidence suggests that use of a structured medication safety enhancement (MSE) simulation program can significantly improve student knowledge and competency in safe medication administration.
PURPOSE
To examine the effects of an educational strategy using a MSE simulation program with integrated technology on the medication administration knowledge, competency, and confidence levels of undergraduate nursing students.
METHODS
This quasi-experimental replication study designed and implemented medication simulations enhanced by integrated information technologies in an undergraduate-nursing curriculum. Third-year BSN students (n = 83) were randomized into intervention or control groups. Control groups participated in standard training while the intervention group received additional clinical simulation experience and debriefing sessions focused on medication safety practices. Participant knowledge was measured using pre/post Medication Safety Knowledge Assessment (MSKA) and competency was evaluated using the Medication Safety Critical Element Checklist (MSCEC).
RESULTS
The MSKA and MSCEC were analyzed using two-sided independent t-tests. Post-test knowledge scores increased in both groups but results were not statistically significant (α = 0. 05). Students who received the medication safetfy enhancement intervention performed significantly better in a subsequent simulation than students who did not have prior simulation experience (p < .001).
CONCLUSION
Findings suggest that educators should consider high fidelity simulation as an evidence-based teaching strategy to engage students in understanding and implementing medication safety practices in the clinical setting.",2020,"Students who received the medication safetfy enhancement intervention performed significantly better in a subsequent simulation than students who did not have prior simulation experience (p < .001).
","['undergraduate-nursing curriculum', 'Third-year BSN students (n\xa0=\xa083', 'undergraduate nursing students']",['standard training while the intervention group received additional clinical simulation experience and debriefing sessions'],"['Post-test knowledge scores', 'Medication Safety Critical Element Checklist (MSCEC']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1098180', 'cui_str': 'bis((di-n-butyl 3,6-dioxaheptanoato)tin)'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",83.0,0.0131788,"Students who received the medication safetfy enhancement intervention performed significantly better in a subsequent simulation than students who did not have prior simulation experience (p < .001).
","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Craig', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA. Electronic address: sjw5y@virginia.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Kastello', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA. Electronic address: jck9e@virginia.edu.'}, {'ForeName': 'Bethany J', 'Initials': 'BJ', 'LastName': 'Cieslowski', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA. Electronic address: bjc6h@virginia.edu.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Rovnyak', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA.'}]",Nurse education today,['10.1016/j.nedt.2020.104605']
1297,33096392,Tocolysis compared with no tocolysis in women with threatened preterm birth and ruptured membranes: A propensity score analysis.,"INTRODUCTION
In women with preterm ruptured membranes and contractions, the administration of tocolysis is controversial. This study compares tocolysis with no tocolysis in women with threatened preterm birth and ruptured membranes.
OBJECTIVE
To compare tocolysis with no tocolysis in women with threatened preterm birth and ruptured membranes.
STUDY DESIGN
Data from the APOSTEL III RCT was combined with data from the National Maternity Hospital, Dublin. In the APOSTEL III trial, women with threatened preterm birth were randomized to atosiban or nifedipine. Patient data from Ireland were obtained from a cohort of women with threatened preterm birth with ruptured membranes. The Irish women received no tocolytic treatment. Only women with ruptured membranes and contractions were selected. We studied women with singleton or twin pregnancies and a gestational age between 25 +0 and 33 +6 weeks. Propensity score matching was performed to create comparable groups. Primary outcome was a composite adverse neonatal outcome. Secondary outcomes were individual components of the primary outcome, as well as neonatal intensive care unit (NICU) admission, gestational age at delivery, prolongation of pregnancy and mode of delivery.
RESULTS
153 women from the Apostel III trial were compared with 51 eligible women of the Irish cohort. We could match 46 women who received tocolysis and 46 women who received no tocolysis. All women had ruptured membranes. Maternal age, BMI, parity and gestational age at study entry were comparable between the groups after matching. There were no statistically significant differences in neonatal composite outcome (9.6 % in the tocolysis group versus 18 % in the control group, OR 0.46, 95 % CI 0.13-1.63). We found a lower incidence of NICU admission in the tocolysis group (63 %) than in the control group (94 %; OR 0.11, 95 % CI 0.03-0.41), which could be explained by differences in national admission policies. There were no statistically significant differences between tocolysis and no tocolysis in any of the other outcomes including sepsis, gestational age at delivery and time to delivery.
CONCLUSION
In this propensity score analysis of women with threatened preterm birth and ruptured membranes, tocolytic therapy did not alter composite adverse neonatal outcome or time to delivery.",2020,"There were no statistically significant differences between tocolysis and no tocolysis in any of the other outcomes including sepsis, gestational age at delivery and time to delivery.
","['women with threatened preterm birth with ruptured membranes', 'women with singleton or twin pregnancies and a gestational age between 25 +0 and 33 +6 weeks', 'women with threatened preterm birth and ruptured membranes', 'All women had ruptured membranes', '153 women from the Apostel III trial were compared with 51 eligible women of the Irish cohort', 'Data from the APOSTEL III RCT was combined with data from the National Maternity Hospital, Dublin', '46 women who received tocolysis and 46 women who received', 'women with threatened preterm birth']","['Tocolysis', 'tocolysis with no tocolysis', 'nifedipine', 'no tocolysis']","['sepsis, gestational age at delivery and time to delivery', 'neonatal intensive care unit (NICU) admission, gestational age at delivery, prolongation of pregnancy and mode of delivery', 'neonatal composite outcome', 'NICU admission', 'composite adverse neonatal outcome']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0233308', 'cui_str': 'Spontaneous rupture of fetal membranes'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1553352', 'cui_str': 'Irish Gaelic language'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0020010', 'cui_str': 'Maternity Hospitals'}, {'cui': 'C0454777', 'cui_str': 'Dublin'}, {'cui': 'C0040348', 'cui_str': 'Tocolysis'}]","[{'cui': 'C0040348', 'cui_str': 'Tocolysis'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}]","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",153.0,0.295046,"There were no statistically significant differences between tocolysis and no tocolysis in any of the other outcomes including sepsis, gestational age at delivery and time to delivery.
","[{'ForeName': 'T M S', 'Initials': 'TMS', 'LastName': 'van Winden', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roos', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'T A J', 'Initials': 'TAJ', 'LastName': 'Nijman', 'Affiliation': 'Leiden University Medical Centre, Department of Obstetrics and Gynecology, Leiden, the Netherlands.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Kleinrouweler', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Olaru', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Ireland.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'McAuliffe', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Ireland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pajkrt', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Oudijk', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands. Electronic address: m.a.oudijk@amsterdamumc.nl.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.10.015']
1298,33097092,Gemcitabine as adjuvant chemotherapy in patients with high-risk early breast cancer-results from the randomized phase III SUCCESS-A trial.,"BACKGROUND
When chemotherapy is indicated in patients with early breast cancer, regimens that contain anthracyclines and taxanes are established standard treatments. Gemcitabine has shown promising effects on the response and prognosis in patients with metastatic breast cancer. The SUCCESS-A trial (NCT02181101) examined the addition of gemcitabine to a standard chemotherapy regimen in high-risk early breast cancer patients.
METHODS
A total of 3754 patients with at least one of the following characteristics were randomly assigned to one of the two treatment arms: nodal positivity, tumor grade 3, age ≤ 35 years, tumor larger than 2 cm, or negative hormone receptor status. The treatment arms received either three cycles of 5-fluorouracil, epirubicin, and cyclophosphamide, followed by three cycles of docetaxel (FEC → Doc); or three cycles of FEC followed by three cycles of docetaxel and gemcitabine (FEC → Doc/Gem). The primary study aim was disease-free survival (DFS), and the main secondary objectives were overall survival (OS) and safety.
RESULTS
No differences were observed in the 5-year DFS or OS between FEC → Doc and FEC → Doc/Gem. The hazard ratio was 0.93 (95% CI, 0.78 to 1.12; P = 0.47) for DFS and 0.94 (95% CI, 0.74 to 1.19; P = 0.60) for OS. For patients treated with FEC → Doc and FEC → Doc/Gem, the 5-year probabilities of DFS were 86.6% and 87.2%, and the 5-year probabilities of OS were 92.8% and 92.5%, respectively.
CONCLUSION
Adding gemcitabine to a standard chemotherapy does not improve the outcomes in patients with high-risk early breast cancer and should therefore not be included in the adjuvant treatment setting.
TRIAL REGISTRATION
Clinicaltrials.gov NCT02181101 and EU Clinical Trials Register EudraCT 2005-000490-21. Registered September 2005.",2020,"The hazard ratio was 0.93 (95% CI, 0.78 to 1.12; P = 0.47) for DFS and 0.94","['patients with early breast cancer', 'patients with high-risk early breast cancer', 'patients with metastatic breast cancer', 'high-risk early breast cancer patients', '3754 patients with at least one of the following characteristics']","['5-fluorouracil, epirubicin, and cyclophosphamide', 'gemcitabine', 'docetaxel and gemcitabine (FEC\u2009→\u2009Doc/Gem', 'docetaxel (FEC\u2009→\u2009Doc', 'Gemcitabine', 'EudraCT']","['disease-free survival (DFS', '5-year probabilities of DFS', '5-year probabilities of OS', '5-year DFS or OS', 'hazard ratio', 'overall survival (OS) and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0060133', 'cui_str': 'FEC protocol'}, {'cui': 'C0011710', 'cui_str': 'desoxycorticosterone'}, {'cui': 'C0445501', 'cui_str': 'Gem'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",3754.0,0.130094,"The hazard ratio was 0.93 (95% CI, 0.78 to 1.12; P = 0.47) for DFS and 0.94","[{'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'de Gregorio', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany. amelie.degregorio@uniklinik-ulm.de.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Häberle', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich-Alexander-University of Erlangen-Nuremberg, Comprehensive Cancer Center EMN, Erlangen, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich-Alexander-University of Erlangen-Nuremberg, Comprehensive Cancer Center EMN, Erlangen, Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Department of Gynecology, University Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Schrader', 'Affiliation': 'Gynecologic-Oncological Practice, Hannover, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Lorenz', 'Affiliation': 'Gynecologic Practice Dr. Lorenz, N. Hecker, Dr. Kreiss-Sender, Braunschweig, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Forstbauer', 'Affiliation': 'Hemato-Oncological Practice Dres Forstbauer and Ziske, Troisdorf, Germany.'}, {'ForeName': 'Thomas W P', 'Initials': 'TWP', 'LastName': 'Friedl', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Emanuel', 'Initials': 'E', 'LastName': 'Bauer', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'de Gregorio', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Deniz', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Visnja', 'Initials': 'V', 'LastName': 'Fink', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Bekes', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Andergassen', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, Division of Gynecologic Oncology and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Tesch', 'Affiliation': 'Department of Oncology, Onkologie Bethanien, Frankfurt, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Sara Y', 'Initials': 'SY', 'LastName': 'Brucker', 'Affiliation': 'Department of Gynecology and Obstetrics, Tübingen University Hospital, Tübingen, Germany.'}, {'ForeName': 'Jens-Uwe', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Department of Gynecology and Breast Center, Charité University Hospital Campus Charité-Mitte, Berlin, Germany.'}, {'ForeName': 'Tanja N', 'Initials': 'TN', 'LastName': 'Fehm', 'Affiliation': 'Department of Gynecology and Obstetrics, Düsseldorf University Hospital, Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Heinrich', 'Affiliation': 'Department of Gynecologic Oncology, Schwerpunktpraxis für Gynäkologische Onkologie, Fürstenwalde, Germany.'}, {'ForeName': 'Krisztian', 'Initials': 'K', 'LastName': 'Lato', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Matthias W', 'Initials': 'MW', 'LastName': 'Beckmann', 'Affiliation': 'Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich-Alexander-University of Erlangen-Nuremberg, Comprehensive Cancer Center EMN, Erlangen, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Rack', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Janni', 'Affiliation': 'Department of Gynecology and Obstetrics, Ulm University Hospital, Prittwitzstrasse 43, 89075, Ulm, Germany.'}]",Breast cancer research : BCR,['10.1186/s13058-020-01348-w']
1299,33097097,NIATx-TI versus typical product training on e-health technology implementation: a clustered randomized controlled trial study protocol.,"BACKGROUND
Substance use disorders (SUDs) lead to tens-of-thousands of overdose deaths and other forms of preventable deaths in the USA each year. This results in over $500 billion per year in societal and economic costs as well as a considerable amount of grief for loved ones of affected individuals. Despite these health and societal consequences, only a small percentage of people seek treatment for SUDs, and the majority of those that seek help fail to achieve long-term sobriety. E-health applications in healthcare have proven to be effective at sustaining treatment and reaching patients traditional treatment pathways would have missed. However, e-health adoption and sustainment rates in healthcare are poor, especially in the SUD treatment sector. Implementation engineering can address this gap in the e-health field by augmenting existing implementation models, which explain organizational and individual e-health behaviors retrospectively, with prospective resources that can guide implementation.
METHODS
This cluster randomized control trial is designed to test two implementation strategies at adopting an evidence-based mobile e-health technology for SUD treatment. The proposed e-health implementation model is the Network for the Improvement of Addiction Treatment-Technology Implementation (NIATx-TI) Framework. This project, based in Iowa, will compare a control condition (using a typical software product training approach that includes in-person staff training followed by access to on-line support) to software implementation utilizing NIATx-TI, which includes change management training, followed by coaching on how to implement and use the mobile application. While e-health spans many modalities and health disciplines, this project will focus on implementing the Addiction Comprehensive Health Enhancement Support System (A-CHESS), an evidence-based SUD treatment recovery app framework. This trial will be conducted in Iowa at 46 organizational sites within 12 SUD treatment agencies. The control arm consists of 23 individual treatment sites based at five organizations, and the intervention arm consists of 23 individual SUD treatment sites based at seven organizations DISCUSSION: This study addresses an issue of substantial public health significance: enhancing the uptake of the growing inventory of patient-centered evidence-based addiction treatment e-health technologies.
TRIAL REGISTRATION
ClinicalTrials.gov , NCT03954184 . Posted 17 May 2019.",2020,This cluster randomized control trial is designed to test two implementation strategies at adopting an evidence-based mobile e-health technology for SUD treatment.,['Iowa at 46 organizational sites within 12 SUD treatment agencies'],['NIATx-TI versus typical product training'],[],"[{'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0436354,This cluster randomized control trial is designed to test two implementation strategies at adopting an evidence-based mobile e-health technology for SUD treatment.,"[{'ForeName': 'Veronica M', 'Initials': 'VM', 'LastName': 'White', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA. vmwhite@wisc.edu.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Molfenter', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Gustafson', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Horst', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Greller', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Gustafson', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'Jee-Seon', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Educational Psychology, University of Wisconsin-Madison, Educational Sciences, 1025 West Johnson St, Madison, WI, 53706-1706, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Preuss', 'Affiliation': 'Division of Behavioral Health, Iowa Department of Public Health, Lucas State Office Building, 321 E. 12th Street, Des Moines, IA, 50319-0075, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Cody', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'Praan', 'Initials': 'P', 'LastName': 'Pisitthakarm', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Toy', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave, Madison, WI, 53706, USA.'}]",Implementation science : IS,['10.1186/s13012-020-01053-4']
1300,33098212,Timing of CGM initiation in pediatric diabetes: The CGM TIME Trial.,"OBJECTIVE
To determine whether timing of CGM initiation offering low glucose suspend (LGS) affects CGM adherence in children and youth starting insulin pump therapy.
METHODS
A 5-site RCT of pump-naïve subjects (aged 5-18 years) with type 1 diabetes (T1D) for at least 1 year compared simultaneous pump and CGM initiation offering LGS vs standard pump therapy with CGM initiation delayed for 6 months. Primary outcome was CGM adherence (hours per 28 days) (MiniMed™ Paradigm™ Veo™ system; CareLink Pro™ software) over 6 months after CGM initiation. Secondary outcome HbA1c was measured centrally. Linear mixed-models and ordinary least squares models were fitted to estimate effect of intervention, and covariates baseline age, T1D duration, HbA1c, gender, ethnicity, hypoglycemia history, clinical site, and association between CGM adherence and HbA1c.
RESULTS
The trial randomized 144/152 (95%) eligible subjects. Baseline mean age was 11.5 ± 3.3(SD) years, T1D duration 3.4 ± 3.1 years, and HbA1c 7.9 ± 0.9%. Six months after CGM initiation, adjusted mean difference in CGM adherence was 62.4 hours per 28 days greater in the Simultaneous Group compared to Delayed Group (P = .007). There was no difference in mean HbA1c at 6 months. However, for each 100 hours of CGM use per 28-day period, HbA1c was 0.39% (95% CI 0.10%-0.69%) lower. Higher CGM adherence was associated with reduced time with glucose >10 mmol/L (P < .001).
CONCLUSION
CGM adherence was higher after 6 months when initiated at same time as pump therapy compared to starting CGM 6 months after pump therapy. Greater CGM adherence was associated with improved HbA1c.",2020,"Higher CGM adherence was associated with reduced time with glucose >10 mmol/L (p<0.001).
","['children and youth starting insulin pump therapy', 'A 5-site RCT of pump-naïve subjects (aged 5-18\u2009years) with type 1 diabetes (T1D) for at least 1 year compared']","['CGM initiation offering low glucose suspend (LGS', 'simultaneous pump and CGM initiation offering LGS vs. standard pump therapy with CGM initiation delayed for 6 months']","['Higher CGM adherence', 'Greater CGM adherence', 'CGM adherence (hours per 28\u2009days) (MiniMed™ Paradigm™ Veo™ system; CareLink™ Pro software', 'CGM adherence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}]","[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0860801', 'cui_str': 'Glucose low'}, {'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0037585', 'cui_str': 'Software'}]",,0.218352,"Higher CGM adherence was associated with reduced time with glucose >10 mmol/L (p<0.001).
","[{'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Lawson', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Kate C', 'Initials': 'KC', 'LastName': 'Verbeeten', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Jennilea M', 'Initials': 'JM', 'LastName': 'Courtney', 'Affiliation': 'Clinical Research Unit, CHEO Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Brenda J', 'Initials': 'BJ', 'LastName': 'Bradley', 'Affiliation': 'Clinical Research Unit, CHEO Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McAssey', 'Affiliation': ""Department of Pediatrics, McMaster Children's Hospital, Hamilton, Ontario, Canada.""}, {'ForeName': 'Cheril', 'Initials': 'C', 'LastName': 'Clarson', 'Affiliation': ""Department of Pediatrics, Children's Hospital, London Health Sciences Centre, Lawson Health Research Institute, London, Ontario, Canada.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kirsch', 'Affiliation': 'Department of Pediatrics, Markham-Stouffville Hospital, Markham, Ontario, Canada.'}, {'ForeName': 'Jacqueline R', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Farid H', 'Initials': 'FH', 'LastName': 'Mahmud', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Cooper', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Clinical Research Unit, CHEO Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Clinical Research Unit, CHEO Research Institute, Ottawa, Ontario, Canada.'}]",Pediatric diabetes,['10.1111/pedi.13144']
1301,33085094,"A single, clinically relevant dose of the GABA B agonist baclofen impairs visuomotor learning.","KEY POINTS
Baclofen is a GABA B agonist prescribed as a treatment for spasticity in stroke, brain injury and multiple sclerosis patients, who are often undergoing concurrent motor rehabilitation. Decreasing GABAergic inhibition is a key feature of motor learning and so there is a possibility that GABA agonist drugs, such as baclofen, could impair these processes, potentially impacting rehabilitation. Here, we examined the effect of 10 mg of baclofen, in 20 young healthy individuals, and found that the drug impaired retention of visuomotor learning with no significant effect on motor sequence learning. Overall baclofen did not alter transcranial magnetic stimulation-measured GABA B inhibition, although the change in GABA B inhibition correlated with aspects of visuomotor learning retention. Further work is needed to investigate whether taking baclofen impacts motor rehabilitation in patients.
ABSTRACT
The GABA B agonist baclofen is taken daily as a treatment for spasticity by millions of stroke, brain injury and multiple sclerosis patients, many of whom are also undergoing motor rehabilitation. However, decreases in GABA are suggested to be a key feature of human motor learning, which raises questions about whether drugs increasing GABAergic activity may impair motor learning and rehabilitation. In this double-blind, placebo-controlled study, we investigated whether a single 10 mg dose of the GABA B agonist baclofen impaired motor sequence learning and visuomotor learning in 20 young healthy participants of both sexes. Participants trained on visuomotor and sequence learning tasks using their right hand. Transcranial magnetic stimulation (TMS) measures of corticospinal excitability, GABA A (short-interval intracortical inhibition , 2.5 ms) and GABA B (long-interval intracortical inhibition , 150 ms) receptor activation were recorded from left M1. Behaviourally, baclofen caused a significant reduction of visuomotor aftereffect (F 1,137.8 = 6.133, P = 0.014) and retention (F 1,130.7 = 4.138, P = 0.044), with no significant changes to sequence learning. There were no overall changes to TMS measured GABAergic inhibition with this low dose of baclofen. This result confirms the causal importance of GABA B inhibition in mediating visuomotor learning and suggests that chronic baclofen use could negatively impact aspects of motor rehabilitation.",2020,"Behaviourally, baclofen caused a significant reduction of visuomotor aftereffect (F(1,137.8) = 6.133, p = 0.014) and retention (F(1,130.7) =","['20 young healthy individuals', '20 young healthy participants of both sexes', 'patients']","['Baclofen', 'placebo', 'GABA B agonist baclofen', 'Transcranial magnetic stimulation (TMS']","['visuomotor aftereffect', 'sequence learning', 'visuomotor learning', 'Overall baclofen', 'motor sequence learning', 'TMS-measured GABA B inhibition', 'corticospinal excitability, GABA A (SICI 2.5ms ) and GABA B (LICI 150ms ) receptor activation', 'motor sequence learning and visuomotor learning']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]",20.0,0.0721447,"Behaviourally, baclofen caused a significant reduction of visuomotor aftereffect (F(1,137.8) = 6.133, p = 0.014) and retention (F(1,130.7) =","[{'ForeName': 'Ainslie', 'Initials': 'A', 'LastName': 'Johnstone', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Grigoras', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Petitet', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Liliana P', 'Initials': 'LP', 'LastName': 'Capitão', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Charlotte J', 'Initials': 'CJ', 'LastName': 'Stagg', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}]",The Journal of physiology,['10.1113/JP280378']
1302,33085123,VVI pacing with normal QRS duration and ventricular function: MOST trial findings relevant to leadless pacemakers.,"BACKGROUND
Leadless pacemakers (LPs) provide ventricular pacing without the risks associated with transvenous leads and device pockets. LPs are appealing for patients who need pacing, but do not need defibrillator or cardiac resynchronization therapy. Most implanted LPs provide right ventricular pacing without atrioventricular synchrony (VVIR mode). The Mode Selection Trial in Sinus Node Dysfunction (MOST) showed similar outcomes in patients randomized to dual-chamber (DDDR) versus ventricular pacing (VVIR). We compared outcomes by pacing mode in LP-eligible patients from MOST.
METHODS
Patients enrolled in the MOST study with an left ventricular ejection fraction (LVEF) >35%, QRS duration (QRSd) <120 ms and no history of ventricular arrhythmias or prior implantable cardioverter defibrillators were included (LP-eligible population). Cox proportional hazards models were used to test the association between pacing mode and death, stroke or heart failure (HF) hospitalization and atrial fibrillation (AF).
RESULTS
Of the 2010 patients enrolled in MOST, 1284 patients (64%) met inclusion criteria. Baseline characteristics were well balanced across included patients randomized to DDDR (N = 630) and VVIR (N = 654). Over 4 years of follow-up, there was no association between pacing mode and death, stroke or HF hospitalization (VVIR HR 1.28 [0.92-1.75]). VVIR pacing was associated with higher risk of AF (HR 1.32 [1.08-1.61], P = .007), particularly in patients with no history of AF (HR 2.38 [1.52-3.85], P < .001).
CONCLUSION
In patients without reduced LVEF or prolonged QRSd who would be eligible for LP, DDDR, and VVIR pacing demonstrated similar rates of death, stroke or HF hospitalization; however, VVIR pacing significantly increased the risk of AF development.",2020,"VVIR pacing was associated with higher risk of AF (HR 1.32 [1.08-1.61], p = 0.007), particularly in patients with no history of AF (HR 2.38 [1.52-3.85], p<0.001).
","['2,010 patients enrolled in MOST, 1,284 patients (64%) met inclusion criteria', 'LP-eligible patients from MOST', 'Patients enrolled in the MOST study with an LVEF >35%, QRSd <120ms and no history of ventricular arrhythmias or prior implantable cardioverter defibrillators were included (LP-eligible population']","['dual chamber (DDDR) vs ventricular pacing (VVIR', 'VVI Pacing']","['pacing mode and death, stroke or heart failure hospitalization', 'rates of death, stroke or heart failure hospitalization', 'pacing mode and death, stroke or heart failure hospitalization and atrial fibrillation (AF', 'LVEF or prolonged QRS duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0428908', 'cui_str': 'Sinus node dysfunction'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}]","[{'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0429025', 'cui_str': 'QRS complex duration'}]",2010.0,0.0306833,"VVIR pacing was associated with higher risk of AF (HR 1.32 [1.08-1.61], p = 0.007), particularly in patients with no history of AF (HR 2.38 [1.52-3.85], p<0.001).
","[{'ForeName': 'Zak', 'Initials': 'Z', 'LastName': 'Loring', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'North', 'Affiliation': 'Department of Statistics, North Carolina State University, Raleigh, North Carolina.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Hellkamp', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Atwater', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Camille G', 'Initials': 'CG', 'LastName': 'Frazier-Mills', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Jackson', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Pokorney', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Gervasio A', 'Initials': 'GA', 'LastName': 'Lamas', 'Affiliation': 'Division of Cardiology, Mount Sinai Medical Center, Miami Beach, Florida.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Piccini', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.14100']
1303,33080378,Study protocol for a randomized controlled trial of mindfulness-based relapse prevention for opioid use disorders.,"The opioid misuse epidemic has reached a crisis level in the United States. Though mindfulness-based relapse prevention (MBRP) has been shown as effective in treating substance use disorders, there is limited research on its application to opioid use disorders specifically, and there is a need to understand the underlying mechanisms. This paper outlines a protocol for a randomized controlled trial of MBRP for opioid use disorders. MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. We will recruit 240 participants who have completed opioid use disorder treatment, and randomize them to an 8-week MBRP group intervention or treatment as usual (TAU) control group. The TAU control group will complete the intervention after 8 weeks. Assessments will take place at baseline, 8 weeks, and 16 weeks. The primary outcome is frequency of opioid use. The secondary outcomes include craving and withdrawal symptoms, time to first opioid use, adherence to medication-assisted treatment plans, perceived stress, quality of life, posttraumatic stress symptoms, and chronic pain. We will also examine the following potential moderators and correlates of intervention outcomes: comorbid diagnoses, life events history, and MBRP intervention adherence. In addition, we will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect. This study will contribute to the evidence base regarding MBRP's efficacy in reducing opioid use, as well as contribute to the understanding of the causal mechanisms and factors that modify treatment outcome for MBRP for substance use disorders.",2020,"The secondary outcomes include craving and withdrawal symptoms, time to first opioid use, adherence to medication-assisted treatment plans, perceived stress, quality of life, posttraumatic stress symptoms, and chronic pain.","['240 participants who have completed opioid use disorder treatment, and randomize them to an 8-week']","['MBRP', 'mindfulness-based relapse prevention (MBRP', 'MBRP group intervention or treatment as usual (TAU) control group']","['craving and withdrawal symptoms, time to first opioid use, adherence to medication-assisted treatment plans, perceived stress, quality of life, posttraumatic stress symptoms, and chronic pain', 'frequency of opioid use', 'emotion regulation skills, executive functioning skills, savoring, and positive and negative affect']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",240.0,0.0377418,"The secondary outcomes include craving and withdrawal symptoms, time to first opioid use, adherence to medication-assisted treatment plans, perceived stress, quality of life, posttraumatic stress symptoms, and chronic pain.","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Zinzow', 'Affiliation': 'Department of Psychology, Clemson University, Clemson, SC 29634, USA. Electronic address: hzinzow@clemson.edu.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC 29634, USA.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Rennert', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC 29634, USA.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Snehal', 'Initials': 'S', 'LastName': 'Lopes', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC 29634, USA.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Karyn', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC 29634, USA.'}, {'ForeName': 'Meenu', 'Initials': 'M', 'LastName': 'Jindal', 'Affiliation': 'Department of Internal Medicine, Prisma Health System, Greenville, SC, 29605, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Stam', 'Affiliation': 'Office of Sponsored Programs, Prisma Health System, Greenville, SC 29605, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mclain', 'Affiliation': 'The Phoenix Center, 1400 Cleveland St., Greenville, SC 29602, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106182']
1304,33080379,Decídetexto: Mobile cessation support for Latino smokers. Study protocol for a randomized clinical trial.,"INTRODUCTION
Latinos, the largest minority group in the U.S., experience tobacco-related disparities, including limited access to cessation resources. Evidence supports the efficacy of mobile interventions for smoking cessation, which may be greater among Latinos, the highest users of text messaging.
OBJECTIVES
To describe the methodology of a randomized clinical trial to evaluate the impact of Decídetexto, a culturally appropriate mobile smoking cessation intervention versus standard care on smoking abstinence (cotinine-verified 7-day point prevalence abstinence) at Month 6 among Latino smokers.
METHODS
Latino smokers (N = 618) will be randomized to one of two conditions: 1) Decídetexto or 2) standard of care. Decídetexto is a mobile smoking cessation intervention (available in English and Spanish) that incorporates three integrated components: 1) a tablet-based software that collects smoking-related information to develop an individualized quit plan, 2) a 24-week text messaging counseling program with interactive capabilities, and 3) pharmacotherapy support. Decídetexto follows the Social Cognitive Theory as theoretical framework. Standard of care consists of printed smoking cessation materials along with referral to telephone quitline. Participants in both groups are given access to free pharmacotherapy (nicotine patches or gum) by calling study phone number. Promotores de Salud will rely on community-based approaches and clinical settings to recruit smokers into the study. All participants will complete follow-up assessments at Week 12 and Month 6.
DISCUSSION
If successful, Decídetexto will be ready to be implemented in different community- and clinic-based settings to reduce tobacco-related disparities.",2020,"Evidence supports the efficacy of mobile interventions for smoking cessation, which may be greater among Latinos, the highest users of text messaging.
","['Latino smokers', 'latino smokers', 'Latino smokers (N\u202f=\u202f618']","['Decídetexto or 2) standard of care', 'Decídetexto', 'pharmacotherapy (nicotine patches or gum', 'Decídetexto, a culturally appropriate mobile smoking cessation intervention versus standard care on smoking abstinence (cotinine-verified 7-day point prevalence abstinence']",[],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",[],618.0,0.0411656,"Evidence supports the efficacy of mobile interventions for smoking cessation, which may be greater among Latinos, the highest users of text messaging.
","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Cartujano-Barrera', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, United States of America. Electronic address: Francisco_Cartujano@URMC.Rochester.edu.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Arana-Chicas', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, United States of America.'}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, Children's Mercy Kansas City, Kansas City, MO, United States of America.""}, {'ForeName': 'Lisa Sanderson', 'Initials': 'LS', 'LastName': 'Cox', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Diaz', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Ellerbeck', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Kristi D', 'Initials': 'KD', 'LastName': 'Graves', 'Affiliation': 'Department of Oncology, Georgetown University, Washington, D.C., United States of America.'}, {'ForeName': 'Chinwe', 'Initials': 'C', 'LastName': 'Ogedegbe', 'Affiliation': 'Emergency and Trauma Center, Hackensack University Medical Center, Hackensack, NJ, United States of America.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Cupertino', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106188']
1305,33080839,Vitamin D Status Impacts Genital Mucosal Immunity and Markers of HIV-1 Susceptibility in Women.,"While vitamin D insufficiency is known to impact a multitude of health outcomes, including HIV-1, little is known about the role of vitamin D-mediated immune regulation in the female reproductive tract (FRT). We performed a pilot clinical study of 20 women with circulating 25(OH)D levels <62.5 nmol/L. Participants were randomized into either weekly or daily high-dose oral vitamin D supplementation groups. In addition to serum vitamin D levels, genital mucosal endpoints, including soluble mediators, immune cell populations, gene expression, and ex vivo HIV-1 infection, were assessed. While systemic vitamin D levels showed a significant increase following supplementation, these changes translated into modest effects on the cervicovaginal factors studied. Paradoxically, post-supplementation vitamin D levels were decreased in cervicovaginal fluids. Given the strong correlation between vitamin D status and HIV-1 infection and the widespread nature of vitamin D deficiency, further understanding of the role of vitamin D immunoregulation in the female reproductive tract is important.",2020,"While systemic vitamin D levels showed a significant increase following supplementation, these changes translated into modest effects on the cervicovaginal factors studied.","['Women', '20 women with circulating 25(OH)D levels <62.5 nmol/L. Participants']",['daily high-dose oral vitamin D supplementation'],"['post-supplementation vitamin D levels', 'serum vitamin D levels, genital mucosal endpoints, including soluble mediators, immune cell populations, gene expression, and ex vivo HIV-1 infection', 'Vitamin D Status Impacts Genital Mucosal Immunity and Markers of HIV-1 Susceptibility']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0302837', 'cui_str': 'Vitamin supplement agent'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0282558', 'cui_str': 'Mucosal Immunity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]",20.0,0.15141,"While systemic vitamin D levels showed a significant increase following supplementation, these changes translated into modest effects on the cervicovaginal factors studied.","[{'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Anderson', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Thurman', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Neelima', 'Initials': 'N', 'LastName': 'Chandra', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Jackson', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Asin', 'Affiliation': 'V.A. Medical Center, White River Junction, VT 05009, USA.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Rollenhagen', 'Affiliation': 'V.A. Medical Center, White River Junction, VT 05009, USA.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Ghosh', 'Affiliation': 'Milken Institute School of Public Health and Health Services, George Washington University, Washington, DC 20052, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'Milken Institute School of Public Health and Health Services, George Washington University, Washington, DC 20052, USA.'}, {'ForeName': 'Nikolas C', 'Initials': 'NC', 'LastName': 'Vann', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Meredith R', 'Initials': 'MR', 'LastName': 'Clark', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}, {'ForeName': 'Gustavo F', 'Initials': 'GF', 'LastName': 'Doncel', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk, VA 23507, USA.'}]",Nutrients,['10.3390/nu12103176']
1306,33080863,Effects of Combining High-Definition Transcranial Direct Current Stimulation with Short-Foot Exercise on Chronic Ankle Instability: A Pilot Randomized and Double-Blinded Study.,"(1) Background: Balance decline is highly prevalent in people suffering from chronic ankle instability (CAI). The control of balance depends upon multiple neurophysiologic systems including the activation of cortical brain regions (e.g., the primary sensorimotor cortex). The excitability of this region, however, is diminished in people with CAI. In this pilot double-blinded randomized controlled trial, we tested the effects of high-definition transcranial direct current stimulation (HD-tDCS) designed to facilitate the excitability of M1 and S1 in combination with short-foot exercise (SFE) training on proprioception and dynamic balance performance in individuals with CAI. (2) Methods: Thirty young adults completed baseline assessments including the Active Movement Extent Discrimination Apparatus (AMEDA), Joint Position Reproduction (JPR) test, Y-balance test, and the Sensory Organization Test (SOT). They were then randomized to receive a four-week intervention of SFE in combination with tDCS (i.e., HD-tDCS+SFE) or sham (i.e., control) stimulation. Baseline assessments were repeated once-weekly throughout the intervention and during a two-week follow-up period. (3) Results: Twenty-eight participants completed this study. Blinding procedures were successful and no adverse events were reported. As compared to the control group, the HD-tDCS+SFE group exhibited significant improvements in the JPR test, the Y balance test, and the SOT at different time points. No group by time interaction was observed in AMEDA test performance. (4) Conclusions: HD-tDCS combined with SFE may improve dynamic balance and proprioception in CAI. Larger, more definitive trials with extended follow-up are warranted.",2020,"As compared to the control group, the HD-tDCS+SFE group exhibited significant improvements in the JPR test, the Y balance test, and the SOT at different time points.","['people with CAI', 'individuals with CAI', 'Thirty young adults', 'Chronic Ankle Instability', 'people suffering from chronic ankle instability (CAI']","['SFE in combination with tDCS (i.e., HD-tDCS+SFE) or sham (i.e., control) stimulation', 'HD-tDCS+SFE', 'Combining High-Definition Transcranial Direct Current Stimulation with Short-Foot Exercise', 'SFE', 'short-foot exercise (SFE) training', 'high-definition transcranial direct current stimulation (HD-tDCS']","['successful and no adverse events', 'JPR test, the Y balance test, and the SOT', 'dynamic balance and proprioception in CAI', 'Active Movement Extent Discrimination Apparatus (AMEDA), Joint Position Reproduction (JPR) test, Y-balance test, and the Sensory Organization Test (SOT', 'proprioception and dynamic balance performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0576226', 'cui_str': 'Short foot'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C0454370', 'cui_str': 'Foot exercises'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1963761', 'cui_str': 'No adverse event'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C4720873', 'cui_str': 'Sensory organization test'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0231481', 'cui_str': 'Active movement'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}]",30.0,0.261914,"As compared to the control group, the HD-tDCS+SFE group exhibited significant improvements in the JPR test, the Y balance test, and the SOT at different time points.","[{'ForeName': 'Yuanbo', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Keyi', 'Initials': 'K', 'LastName': 'Yin', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhuang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'The Hinda and Arthur Marcus Institute for Aging Research, Hebrew Senior Life, Boston, MA 02131, USA.'}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The Hinda and Arthur Marcus Institute for Aging Research, Hebrew Senior Life, Boston, MA 02131, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}]",Brain sciences,['10.3390/brainsci10100749']
1307,33081783,Relationships between accelerometry and general compensatory movements of the upper limb after stroke.,"BACKGROUND
Standardized assessments are used in rehabilitation clinics after stroke to measure restoration versus compensatory movements of the upper limb. Accelerometry is an emerging tool that can bridge the gap between in- and out-of-clinic assessments of the upper limb, but is limited in that it currently does not capture the quality of a person's movement, an important concept to assess compensation versus restoration. The purpose of this analysis was to characterize how accelerometer variables may reflect upper limb compensatory movement patterns after stroke.
METHODS
This study was a secondary analysis of an existing data set from a Phase II, single-blind, randomized, parallel dose-response trial (NCT0114369). Sources of data utilized were: (1) a compensatory movement score derived from video analysis of the Action Research Arm Test (ARAT), and (2) calculated accelerometer variables quantifying time, magnitude and variability of upper limb movement from the same time point during study participation for both in-clinic and out-of-clinic recording periods.
RESULTS
Participants had chronic upper limb paresis of mild to moderate severity. Compensatory movement scores varied across the sample, with a mean of 73.7 ± 33.6 and range from 11.5 to 188. Moderate correlations were observed between the compensatory movement score and each accelerometer variable. Accelerometer variables measured out-of-clinic had stronger relationships with compensatory movements, compared with accelerometer variables in-clinic. Variables quantifying time, magnitude, and variability of upper limb movement out-of-clinic had relationships to the compensatory movement score.
CONCLUSIONS
Accelerometry is a tool that, while measuring movement quantity, can also reflect the use of general compensatory movement patterns of the upper limb in persons with chronic stroke. Individuals who move their limbs more in daily life with respect to time and variability tend to move with less movement compensations and more typical movement patterns. Likewise, individuals who move their paretic limbs less and their non-paretic limb more in daily life tend to move with more movement compensations at all joints in the paretic limb and less typical movement patterns.",2020,Individuals who move their limbs more in daily life with respect to time and variability tend to move with less movement compensations and more typical movement patterns.,['persons with chronic stroke'],[],['Compensatory movement scores'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]",[],"[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0394398,Individuals who move their limbs more in daily life with respect to time and variability tend to move with less movement compensations and more typical movement patterns.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Barth', 'Affiliation': 'Washington University School of Medicine, Program in Physical Therapy, St. Louis, MO, USA.'}, {'ForeName': 'Joeseph W', 'Initials': 'JW', 'LastName': 'Klaesner', 'Affiliation': 'Washington University School of Medicine, Program in Physical Therapy, St. Louis, MO, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Lang', 'Affiliation': 'Washington University School of Medicine, Program in Physical Therapy, St. Louis, MO, USA. langc@wustl.edu.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00773-4']
1308,33081817,Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan.,"BACKGROUND
There is an urgent need for treatments that can shorten hospitalization and lower the risk of secondary infection and death in patients with corona disease. The ProPac-COVID trial evaluates whether combination therapy with macrolide azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy, and pre-emptive treatment of supra-infections can shorten hospitalization duration and reduce the risk of non-invasive ventilation, treatment in the intensive care unit, and death in patients with acute hospital admission and a positive test for 2019-nCoV and symptoms of COVID-19 disease.
METHODS
The ProPAC-COVID is a multi-center, randomized, placebo-controlled, double-blinded clinical trial. The primary outcome is number of days spent alive and out of hospital within 14 days from randomization. Randomization will be in blocks of unknown size, and the final allocation will be stratified for age, site of recruitment, and whether the patient has any chronic lung diseases. Data is analyzed using intention-to-treat (ITT) principles, and main analyses will also be subject to modified ITT analysis and per protocol analysis.
DISCUSSION
This paper describes the detailed statistical analysis plan for the evaluation of primary and secondary endpoints of the ProPAC-COVID study. Enrolment of patients to the ProPAC-COVID study is still ongoing. The purpose of this paper is to provide primary publication of study results to prevent selective reporting of outcomes, data-driven analysis, and to increase transparency.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04322396 . Registered on 26 March 2020.",2020,"BACKGROUND
There is an urgent need for treatments that can shorten hospitalization and lower the risk of secondary infection and death in patients with corona disease.","['hospitalized patients with COVID-19 (ProPAC-COVID', 'patients with corona disease', 'patients with acute hospital admission and a positive test for 2019-nCoV and symptoms of COVID-19 disease']","['azithromycin and hydroxychloroquine', 'placebo', 'macrolide azithromycin and hydroxychloroquine']",['number of days spent alive and out of hospital'],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0033518', 'cui_str': 'PROPAC'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003240', 'cui_str': 'Macrolide antibiotic product'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",,0.301302,"BACKGROUND
There is an urgent need for treatments that can shorten hospitalization and lower the risk of secondary infection and death in patients with corona disease.","[{'ForeName': 'Pradeesh', 'Initials': 'P', 'LastName': 'Sivapalan', 'Affiliation': 'Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark. Pradeesh.s@dadlnet.dk.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Amager and Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Therese Sophie', 'Initials': 'TS', 'LastName': 'Lappere', 'Affiliation': 'Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Josefin Viktoria', 'Initials': 'JV', 'LastName': 'Eklöf', 'Affiliation': 'Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Saher Burhan', 'Initials': 'SB', 'LastName': 'Shaker', 'Affiliation': 'Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Uffe Christian Steinholtz', 'Initials': 'UCS', 'LastName': 'Bødtger', 'Affiliation': 'Næstved, Slagelse and Ringsted Hospitals, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Browatzki', 'Affiliation': 'Nordsjællands Hospital Hillerød, University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Christian Niels', 'Initials': 'CN', 'LastName': 'Meyer', 'Affiliation': 'Zeeland University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Ulla Møller', 'Initials': 'UM', 'LastName': 'Weinreich', 'Affiliation': 'Aalborg University Hospital, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Christian B', 'Initials': 'CB', 'LastName': 'Laursen', 'Affiliation': 'Odense University Hospital, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Biering-Sørensen', 'Affiliation': 'Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip Krag', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens D', 'Initials': 'JD', 'LastName': 'Lundgren', 'Affiliation': 'Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens-Ulrik Stæhr', 'Initials': 'JS', 'LastName': 'Jensen', 'Affiliation': 'Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",Trials,['10.1186/s13063-020-04795-0']
1309,33082342,A pragmatic randomized controlled trial reports lack of efficacy of hydroxychloroquine on coronavirus disease 2019 viral kinetics.,"Here, we randomized 53 patients hospitalized with coronavirus disease 2019 (COVID-19) to hydroxychloroquine therapy (at a dose of 400 mg twice daily for seven days) in addition to standard care or standard care alone (ClinicalTrials.gov Identifier, NCT04316377). All severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive patients 18 years of age or older were eligible for study inclusion if they had moderately severe COVID-19 at admission. Treatment with hydroxychloroquine did not result in a significantly greater rate of decline in SARS-CoV-2 oropharyngeal viral load compared to standard care alone during the first five days. Our results suggest no important antiviral effect of hydroxychloroquine in humans infected with SARS-CoV-2.",2020,Treatment with hydroxychloroquine did not result in a significantly greater rate of decline in SARS-CoV-2 oropharyngeal viral load compared to standard care alone during the first five days.,"['53 patients hospitalized with coronavirus disease 2019 (COVID-19) to', 'All severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', 'coronavirus disease 2019 viral kinetics', 'positive patients 18 years of age or older were eligible for study inclusion if they had moderately severe COVID-19 at admission']","['hydroxychloroquine', 'hydroxychloroquine therapy (at a dose of 400\u2009mg twice daily for seven days) in addition to standard care or standard care alone']",['rate of decline in SARS-CoV-2 oropharyngeal viral load'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C5190549', 'cui_str': 'Hydroxychloroquine therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",53.0,0.292815,Treatment with hydroxychloroquine did not result in a significantly greater rate of decline in SARS-CoV-2 oropharyngeal viral load compared to standard care alone during the first five days.,"[{'ForeName': 'Magnus Nakrem', 'Initials': 'MN', 'LastName': 'Lyngbakken', 'Affiliation': 'Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Jan-Erik', 'Initials': 'JE', 'LastName': 'Berdal', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Eskesen', 'Affiliation': 'Department of Infectious Diseases, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Kvale', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Inge Christoffer', 'Initials': 'IC', 'LastName': 'Olsen', 'Affiliation': 'Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Corina Silvia', 'Initials': 'CS', 'LastName': 'Rueegg', 'Affiliation': 'Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anbjørg', 'Initials': 'A', 'LastName': 'Rangberg', 'Affiliation': 'Center for Laboratory Medicine, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Christine Monceyron', 'Initials': 'CM', 'LastName': 'Jonassen', 'Affiliation': 'Center for Laboratory Medicine, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Omland', 'Affiliation': 'Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Røsjø', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway. helge.rosjo@medisin.uio.no.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Dalgard', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}]",Nature communications,['10.1038/s41467-020-19056-6']
1310,33085861,Anti-Siglec-8 Antibody for Eosinophilic Gastritis and Duodenitis.,"BACKGROUND
Eosinophilic gastritis and duodenitis are characterized by gastrointestinal mucosal eosinophilia, chronic symptoms, impaired quality of life, and a lack of adequate treatments. Mast-cell activity may contribute to the pathogenesis of the conditions. AK002 (lirentelimab) is an anti-Siglec-8 antibody that depletes eosinophils and inhibits mast cells and that has shown potential in animal models as a treatment for eosinophilic gastritis and duodenitis.
METHODS
In this phase 2 trial, we randomly assigned adults who had symptomatic eosinophilic gastritis, eosinophilic duodenitis, or both conditions in a 1:1:1 ratio to receive four monthly infusions of low-dose AK002, high-dose AK002, or placebo. The primary end point was the change in gastrointestinal eosinophil count from baseline to 2 weeks after the final dose; to maximize statistical power, we evaluated this end point in the placebo group as compared with the combined AK002 group. Secondary end points were treatment response (>30% reduction in total symptom score and >75% reduction in gastrointestinal eosinophil count) and the change in total symptom score.
RESULTS
Of the 65 patients who underwent randomization, 43 were assigned to receive AK002 and 22 were assigned to receive placebo. The mean percentage change in gastrointestinal eosinophil count was -86% in the combined AK002 group, as compared with 9% in the placebo group (least-squares mean difference, -98 percentage points; 95% confidence interval [CI], -121 to -76; P<0.001). Treatment response occurred in 63% of the patients who received AK002 and in 5% of the patients who received placebo (difference, 58 percentage points; 95% CI, 36 to 74; P<0.001). The mean change in total symptom score was -48% with AK002 and -22% with placebo (least-squares mean difference, -26 percentage points; 95% CI, -44 to -9; P = 0.004). Adverse events associated with AK002 were similar to those with placebo, with the exception of higher percentages of patients having mild-to-moderate infusion-related reactions with AK002 (60% in the combined AK002 group and 23% in the placebo group).
CONCLUSIONS
In patients with eosinophilic gastritis or duodenitis, AK002 reduced gastrointestinal eosinophils and symptoms. Infusion-related reactions were more common with AK002 than with placebo. (Funded by Allakos; ENIGMA ClinicalTrials.gov number, NCT03496571.).",2020,"Treatment response occurred in 63% of the patients who received AK002 and in 5% of the patients who received placebo (difference, 58 percentage points; 95% CI, 36 to 74; P<0.001).","['adults who had symptomatic eosinophilic gastritis, eosinophilic duodenitis, or both conditions in a 1:1:1 ratio to receive four monthly infusions of', '65 patients who underwent randomization']","['placebo', 'low-dose AK002, high-dose AK002, or placebo']","['gastrointestinal eosinophil count', 'total symptom score', 'gastrointestinal eosinophils and symptoms', 'mean change in total symptom score', 'change in gastrointestinal eosinophil count', 'Treatment response']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0267154', 'cui_str': 'Eosinophilic gastritis'}, {'cui': 'C4305493', 'cui_str': 'Eosinophilic duodenitis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.46767,"Treatment response occurred in 63% of the patients who received AK002 and in 5% of the patients who received placebo (difference, 58 percentage points; 95% CI, 36 to 74; P<0.001).","[{'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Peterson', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Murray', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Gary W', 'Initials': 'GW', 'LastName': 'Falk', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Gonsalves', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Mirna', 'Initials': 'M', 'LastName': 'Chehade', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Genta', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Leung', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Paneez', 'Initials': 'P', 'LastName': 'Khoury', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Klion', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Hazan', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vaezi', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Bledsoe', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Sandy R', 'Initials': 'SR', 'LastName': 'Durrani', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Shaw', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Chang', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Bhupinder', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Amol P', 'Initials': 'AP', 'LastName': 'Kamboj', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Henrik S', 'Initials': 'HS', 'LastName': 'Rasmussen', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Rothenberg', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Hirano', 'Affiliation': ""From the University of North Carolina, Chapel Hill (E.S.D.); the University of Utah, Salt Lake City (K.A.P.); Mayo Clinic Rochester, Rochester, MN (J.A.M., A.C.B.); the University of Pennsylvania Perelman School of Medicine, Philadelphia (G.W.F.); Northwestern University, Chicago (N.G., I.H.); the Icahn School of Medicine at Mount Sinai, New York (M.C.); Baylor College of Medicine, Houston (R.M.G.); Tufts University, Boston (J.L.); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (P.K., A.D.K.); Ventura Clinical Trials, Ventura (S.H.), and Allakos, Redwood City (C.S., A.T.C., B.S., A.P.K., H.S.R.) - both in California; Vanderbilt University, Nashville (M.V.); the Division of Allergy and Immunology, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati (S.R.D., M.E.R.); and Pharma Data Associates, Piscataway, NJ (C.W.).""}]",The New England journal of medicine,['10.1056/NEJMoa2012047']
1311,33099054,"A randomised controlled trial of metacognitive training for psychosis, depression, and belief flexibility.","BACKGROUND
Metacognitive training (MCT) has been shown to be effective in reducing psychotic symptoms, including delusions. However, less is known on whether MCT, or its specific modules, are effective in ameliorating reasoning biases e.g. belief flexibility. As inflexibility in appraisal has been associated with psychosis and major depressive disorder (MDD), this study examined the efficacy of a 4-session MCT on delusions, depression, and belief flexibility, in two clinical groups (Psychosis and Depression).
METHODS
This study adopted a single-blind randomised controlled design, with patients with schizophrenia spectrum disorders (and delusions) and patients with MDD being randomised, respectively, into the MCT condition or a treatment-as-usual (TAU) condition. The MCT intervention consisted of specific modules targeting belief flexibility. Participants were assessed before and after treatment, and at 1- and 6-month follow-ups.
RESULTS
Among the 113 participants, 27 patients with psychosis and 29 patients with MDD attended MCT. There were significant improvements in psychotic symptoms, especially delusions, for the Psychosis group, and in depressive symptoms for the MDD group. Symptom improvements following MCT were of large effect sizes, were significantly greater than TAU, and persisted at 6-month. Belief flexibility also improved in both groups, although changes were smaller in size and were not significantly greater than TAU.
LIMITATIONS
An active control condition was not included.
CONCLUSIONS
This study demonstrated large and stable symptom reductions in delusions and depression, and smaller (yet stable) improvement in belief flexibility across groups, following a 4-session MCT, carrying implications for transdiagnostic process-based interventions and their mechanisms of change.",2020,"There were significant improvements in psychotic symptoms, especially delusions, for the Psychosis group, and in depressive symptoms for the MDD group.","['patients with schizophrenia spectrum disorders (and delusions) and patients with MDD being randomised, respectively, into the MCT condition or a treatment-as-usual (TAU) condition', '113 participants, 27 patients with psychosis and 29 patients with MDD attended MCT']","['MCT', 'Metacognitive training (MCT', 'metacognitive training']","['Belief flexibility', 'depressive symptoms', 'psychotic symptoms, especially delusions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}]",27.0,0.0534335,"There were significant improvements in psychotic symptoms, especially delusions, for the Psychosis group, and in depressive symptoms for the MDD group.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Ho-Wai So', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR. Electronic address: shwso@psy.cuhk.edu.hk.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Hoi-Kei Chan', 'Affiliation': 'Alice Ho Miu Ling Nethersole Hospital, 11 Chuen On Road, Tai Po, N.T., Hong Kong SAR.'}, {'ForeName': 'Cheris', 'Initials': 'C', 'LastName': 'Kit-Wa Wong', 'Affiliation': 'Tai Po Hospital, 9 Chuen On Road, Tai Po, N.T., Hong Kong SAR.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Wing-Ka Ching', 'Affiliation': 'Castle Peak Hospital, 15 Tsing Chung Koon Road, Tuen Mun, Hong Kong SAR.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Sze-Wai Lee', 'Affiliation': 'Castle Peak Hospital, 15 Tsing Chung Koon Road, Tuen Mun, Hong Kong SAR.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Chi-Wing Wong', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Kin-Hei Chung', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Alyse Yu', 'Initials': 'AY', 'LastName': 'Hung', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Oi-Yin Wong', 'Affiliation': 'Castle Peak Hospital, 15 Tsing Chung Koon Road, Tuen Mun, Hong Kong SAR.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sau-Man Chan', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong, Tai Po Hospital, 9 Chuen On Road, Tai Po, N.T., Hong Kong SAR.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.126']
1312,33099083,Selfhood triumvirate: From phenomenology to brain activity and back again.,"Recently, a three-dimensional construct model for complex experiential Selfhood has been proposed (Fingelkurts, Fingelkurts, & Kallio-Tamminen, 2016b,c). According to this model, three specific subnets (or modules) of the brain self-referential network (SRN) are responsible for the manifestation of three aspects/features of the subjective sense of Selfhood. Follow up multiple studies established a tight relation between alterations in the functional integrity of the triad of SRN modules and related to them three aspects/features of the sense of self; however, the causality of this relation is yet to be shown. In this article we approached the question of causality by exploring functional integrity within the three SRN modules that are thought to underlie the three phenomenal components of Selfhood while these components were manipulated mentally by experienced meditators in a controlled and independent manner. Participants were requested, in a block-randomised manner, to mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG). This EEG-data was complemented by first-person phenomenological reports and standardised questionnaires which focused on subjective contents of three aspects of Selfhood. The results of the study strengthen the case for a direct causative relationship between three phenomenological aspects of Selfhood and related to them three modules of the brain SRN. Furthermore, the putative integrative model of the dynamic interrelations among three modules of the SRN has been proposed.",2020,"Participants were requested, in a block-randomised manner, to mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG).",[],"['mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG']",[],[],"[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013081', 'cui_str': 'Down-regulation'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",[],,0.0183146,"Participants were requested, in a block-randomised manner, to mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG).","[{'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Fingelkurts', 'Affiliation': 'BM-Science - Brain and Mind Technologies Research Centre, Espoo, Finland. Electronic address: andrew.fingelkurts@bm-science.com.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Fingelkurts', 'Affiliation': 'BM-Science - Brain and Mind Technologies Research Centre, Espoo, Finland.'}, {'ForeName': 'Tarja', 'Initials': 'T', 'LastName': 'Kallio-Tamminen', 'Affiliation': 'Physics Foundations Society and Society for Natural Philosophy, Helsinki, Finland.'}]",Consciousness and cognition,['10.1016/j.concog.2020.103031']
1313,33099092,Back foot influence on dorsiflexion using three different positions of the weight bearing lunge test.,"OBJECTIVES
To determine whether back foot (BF) position influences dorsiflexion range of motion (DFROM) during three different positions of the weight bearing lunge test (WBLT).
DESIGN
Randomised, repeated measures design.
SETTING
Sports clubs.
PARTICIPANTS
52 athletes participating in cutting and pivoting sports.
MAIN OUTCOME MEASURES
DFROM was obtained using a WBLT in three different BF positions: BF heel in full contact with the floor, BF heel raised off the floor and BF was non weight bearing (NWB). All measurements were obtained using three methods: inclinometer at the tibial tuberosity, toe to wall distance and goniometer angle from the lateral malleolus to the fibula head. Differences between testing positions were determined using a repeated measures one-way ANOVA and reliability analysis was performed using the Intraclass Correlation Coefficient (ICC).
RESULTS
DFROM was statistically significantly different for all three positions of the WBLT for each measurement technique (P < .001). These results were associated with large effect sizes for all BF positions and measurement techniques. Reliability ICC values were excellent for all measurements (ICC 0.94-0.99).
CONCLUSIONS
Results show that DFROM differs depending upon the position of the BF during the WBLT. Further research is needed to establish the reproducibility of these three BF positions due to the variability observed.",2020,"RESULTS
DFROM was statistically significantly different for all three positions of the WBLT for each measurement technique (P < .001).","['Sports clubs', '52 athletes participating in cutting and pivoting sports']",[],"['BF positions: BF heel in full contact with the floor, BF heel raised off the floor and BF was non weight bearing (NWB', 'DFROM', 'back foot (BF) position influences dorsiflexion range of motion (DFROM', 'Reliability ICC values']","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}]",[],"[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0445100', 'cui_str': 'Non-weight-bearing'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",52.0,0.0302354,"RESULTS
DFROM was statistically significantly different for all three positions of the WBLT for each measurement technique (P < .001).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Cady', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Oxstalls Campus, Oxstalls Lane, Gloucester, GL2 9HW, UK; School of Life and Medical Sciences, University of Hertfordshire, College Lane, Hatfield, Hertfordshire, AL10 9AB, UK. Electronic address: k.cady2@herts.ac.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Ste Croix', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Oxstalls Campus, Oxstalls Lane, Gloucester, GL2 9HW, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Deighan', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Oxstalls Campus, Oxstalls Lane, Gloucester, GL2 9HW, UK.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.10.005']
1314,33099227,Effect of growth hormone treatment on circulating levels of NT-proBNP in patients with ischemic heart failure.,"AIMS
Growth hormone (GH) therapy in heart failure (HF) is controversial. We investigated the cardiovascular effects of GH in patients with chronic HF due to ischemic heart disease.
METHODS
In a double-blind, placebo-controlled trial, we randomly assigned 37 patients (mean age 66 years; 95% male) with ischemic HF (ejection fraction [EF] < 40%) to a 9-month treatment with either recombinant human GH (1.4 mg every other day) or placebo, with subsequent 3-month treatment-free follow-up. The primary outcome was change in left ventricular (LV) end-systolic volume measured by cardiac magnetic resonance (CMR). Secondary outcomes comprised changes in cardiac structure and EF. Prespecified tertiary outcomes included changes in New York Heat Association (NYHA) functional class and quality of life (QoL), as well as levels of insulin-like growth factor-1 (IGF-1) and N-terminal pro-brain natriuretic peptide (NT-proBNP).
RESULTS
No changes in cardiac structure or systolic function were identified in either treatment group; nor did GH treatment affect QoL or functional class. In the GH group, circulating levels of IGF-1 doubled from baseline (+105%; p < 0.001) and NT-proBNP levels halved (-48%; p < 0.001) during the treatment period, with subsequently a partial return of both towards baseline levels. No changes in IGF-1 or NT-proBNP were observed in the placebo group at any time during the study.
CONCLUSION
In patients with chronic ischemic HF, nine months of GH treatment was associated with significant increases in levels of IGF-1 and reductions in levels of NT-proBNP, but did not affect cardiac structure, systolic function or functional capacity.",2020,No changes in cardiac structure or systolic function were identified in either treatment group; nor did GH treatment affect QoL or functional class.,"['patients with chronic HF due to ischemic heart disease', 'heart failure (HF', 'patients with ischemic heart failure', '37 patients (mean age 66\xa0years; 95% male) with ischemic HF']","['growth hormone treatment', 'GH', 'recombinant human GH', 'placebo', 'Growth hormone (GH) therapy']","['circulating levels of IGF-1', 'circulating levels of NT-proBNP', 'changes in cardiac structure and EF', 'changes in New York Heat Association (NYHA) functional class and quality of life (QoL), as well as levels of insulin-like growth factor-1 (IGF-1) and N-terminal pro-brain natriuretic peptide (NT-proBNP', 'IGF-1 or NT-proBNP', 'NT-proBNP levels', 'change in left ventricular (LV) end-systolic volume measured by cardiac magnetic resonance (CMR', 'cardiac structure or systolic function', 'cardiac structure, systolic function or functional capacity', 'levels of IGF-1 and reductions in levels of NT-proBNP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1533071', 'cui_str': 'N terminal pro-brain natriuretic peptide level'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",37.0,0.265861,No changes in cardiac structure or systolic function were identified in either treatment group; nor did GH treatment affect QoL or functional class.,"[{'ForeName': 'Kristjan', 'Initials': 'K', 'LastName': 'Karason', 'Affiliation': 'Departments of Cardiology and Transplantation, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Electronic address: kristjan.karason@gu.se.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Bobbio', 'Affiliation': 'Departments of Cardiology and Transplantation, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Polte', 'Affiliation': 'Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Departments of Clinical Physiology and Radiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Entela', 'Initials': 'E', 'LastName': 'Bollano', 'Affiliation': 'Departments of Cardiology and Transplantation, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Peterson', 'Affiliation': 'Department of Medicine, Lidköping Hospital, Lidköping, Sweden.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cittadini', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Caidahl', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institute (KI), Stockholm, Sweden.'}, {'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Hjalmarson', 'Affiliation': 'Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Bengt-Åke', 'Initials': 'BÅ', 'LastName': 'Bengtsson', 'Affiliation': 'Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ekelund', 'Affiliation': 'Centre of Registers Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Jörgen', 'Initials': 'J', 'LastName': 'Isgaard', 'Affiliation': 'Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101359']
1315,33075160,Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis.,"BACKGROUND
Postoperative nausea and vomiting (PONV) is a common adverse effect of anaesthesia and surgery. Up to 80% of patients may be affected. These outcomes are a major cause of patient dissatisfaction and may lead to prolonged hospital stay and higher costs of care along with more severe complications. Many antiemetic drugs are available for prophylaxis. They have various mechanisms of action and side effects, but there is still uncertainty about which drugs are most effective with the fewest side effects.
OBJECTIVES
• To compare the efficacy and safety of different prophylactic pharmacologic interventions (antiemetic drugs) against no treatment, against placebo, or against each other (as monotherapy or combination prophylaxis) for prevention of postoperative nausea and vomiting in adults undergoing any type of surgery under general anaesthesia • To generate a clinically useful ranking of antiemetic drugs (monotherapy and combination prophylaxis) based on efficacy and safety • To identify the best dose or dose range of antiemetic drugs in terms of efficacy and safety SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), ClinicalTrials.gov, and reference lists of relevant systematic reviews. The first search was performed in November 2017 and was updated in April 2020. In the update of the search, 39 eligible studies were found that were not included in the analysis (listed as awaiting classification).
SELECTION CRITERIA
Randomized controlled trials (RCTs) comparing effectiveness or side effects of single antiemetic drugs in any dose or combination against each other or against an inactive control in adults undergoing any type of surgery under general anaesthesia. All antiemetic drugs belonged to one of the following substance classes: 5-HT₃ receptor antagonists, D₂ receptor antagonists, NK₁ receptor antagonists, corticosteroids, antihistamines, and anticholinergics. No language restrictions were applied. Abstract publications were excluded.
DATA COLLECTION AND ANALYSIS
A review team of 11 authors independently assessed trials for inclusion and risk of bias and subsequently extracted data. We performed pair-wise meta-analyses for drugs of direct interest (amisulpride, aprepitant, casopitant, dexamethasone, dimenhydrinate, dolasetron, droperidol, fosaprepitant, granisetron, haloperidol, meclizine, methylprednisolone, metoclopramide, ondansetron, palonosetron, perphenazine, promethazine, ramosetron, rolapitant, scopolamine, and tropisetron) compared to placebo (inactive control). We performed network meta-analyses (NMAs) to estimate the relative effects and ranking (with placebo as reference) of all available single drugs and combinations. Primary outcomes were vomiting within 24 hours postoperatively, serious adverse events (SAEs), and any adverse event (AE). Secondary outcomes were drug class-specific side effects (e.g. headache), mortality, early and late vomiting, nausea, and complete response. We performed subgroup network meta-analysis with dose of drugs as a moderator variable using dose ranges based on previous consensus recommendations. We assessed certainty of evidence of NMA treatment effects for all primary outcomes and drug class-specific side effects according to GRADE (CINeMA, Confidence in Network Meta-Analysis). We restricted GRADE assessment to single drugs of direct interest compared to placebo.
MAIN RESULTS
We included 585 studies (97,516 randomized participants). Most of these studies were small (median sample size of 100); they were published between 1965 and 2017 and were primarily conducted in Asia (51%), Europe (25%), and North America (16%). Mean age of the overall population was 42 years. Most participants were women (83%), had American Society of Anesthesiologists (ASA) physical status I and II (70%), received perioperative opioids (88%), and underwent gynaecologic (32%) or gastrointestinal surgery (19%) under general anaesthesia using volatile anaesthetics (88%). In this review, 44 single drugs and 51 drug combinations were compared. Most studies investigated only single drugs (72%) and included an inactive control arm (66%). The three most investigated single drugs in this review were ondansetron (246 studies), dexamethasone (120 studies), and droperidol (97 studies). Almost all studies (89%) reported at least one efficacy outcome relevant for this review. However, only 56% reported at least one relevant safety outcome. Altogether, 157 studies (27%) were assessed as having overall low risk of bias, 101 studies (17%) overall high risk of bias, and 327 studies (56%) overall unclear risk of bias. Vomiting within 24 hours postoperatively Relative effects from NMA for vomiting within 24 hours (282 RCTs, 50,812 participants, 28 single drugs, and 36 drug combinations) suggest that 29 out of 36 drug combinations and 10 out of 28 single drugs showed a clinically important benefit (defined as the upper end of the 95% confidence interval (CI) below a risk ratio (RR) of 0.8) compared to placebo. Combinations of drugs were generally more effective than single drugs in preventing vomiting. However, single NK₁ receptor antagonists showed treatment effects similar to most of the drug combinations. High-certainty evidence suggests that the following single drugs reduce vomiting (ordered by decreasing efficacy): aprepitant (RR 0.26, 95% CI 0.18 to 0.38, high certainty, rank 3/28 of single drugs); ramosetron (RR 0.44, 95% CI 0.32 to 0.59, high certainty, rank 5/28); granisetron (RR 0.45, 95% CI 0.38 to 0.54, high certainty, rank 6/28); dexamethasone (RR 0.51, 95% CI 0.44 to 0.57, high certainty, rank 8/28); and ondansetron (RR 0.55, 95% CI 0.51 to 0.60, high certainty, rank 13/28). Moderate-certainty evidence suggests that the following single drugs probably reduce vomiting: fosaprepitant (RR 0.06, 95% CI 0.02 to 0.21, moderate certainty, rank 1/28) and droperidol (RR 0.61, 95% CI 0.54 to 0.69, moderate certainty, rank 20/28). Recommended and high doses of granisetron, dexamethasone, ondansetron, and droperidol showed clinically important benefit, but low doses showed no clinically important benefit. Aprepitant was used mainly at high doses, ramosetron at recommended doses, and fosaprepitant at doses of 150 mg (with no dose recommendation available). Frequency of SAEs Twenty-eight RCTs were included in the NMA for SAEs (10,766 participants, 13 single drugs, and eight drug combinations). The certainty of evidence for SAEs when using one of the best and most reliable anti-vomiting drugs (aprepitant, ramosetron, granisetron, dexamethasone, ondansetron, and droperidol compared to placebo) ranged from very low to low. Droperidol (RR 0.88, 95% CI 0.08 to 9.71, low certainty, rank 6/13) may reduce SAEs. We are uncertain about the effects of aprepitant (RR 1.39, 95% CI 0.26 to 7.36, very low certainty, rank 11/13), ramosetron (RR 0.89, 95% CI 0.05 to 15.74, very low certainty, rank 7/13), granisetron (RR 1.21, 95% CI 0.11 to 13.15, very low certainty, rank 10/13), dexamethasone (RR 1.16, 95% CI 0.28 to 4.85, very low certainty, rank 9/13), and ondansetron (RR 1.62, 95% CI 0.32 to 8.10, very low certainty, rank 12/13). No studies reporting SAEs were available for fosaprepitant. Frequency of any AE Sixty-one RCTs were included in the NMA for any AE (19,423 participants, 15 single drugs, and 11 drug combinations). The certainty of evidence for any AE when using one of the best and most reliable anti-vomiting drugs (aprepitant, ramosetron, granisetron, dexamethasone, ondansetron, and droperidol compared to placebo) ranged from very low to moderate. Granisetron (RR 0.92, 95% CI 0.80 to 1.05, moderate certainty, rank 7/15) probably has no or little effect on any AE. Dexamethasone (RR 0.77, 95% CI 0.55 to 1.08, low certainty, rank 2/15) and droperidol (RR 0.89, 95% CI 0.81 to 0.98, low certainty, rank 6/15) may reduce any AE. Ondansetron (RR 0.95, 95% CI 0.88 to 1.01, low certainty, rank 9/15) may have little or no effect on any AE. We are uncertain about the effects of aprepitant (RR 0.87, 95% CI 0.78 to 0.97, very low certainty, rank 3/15) and ramosetron (RR 1.00, 95% CI 0.65 to 1.54, very low certainty, rank 11/15) on any AE. No studies reporting any AE were available for fosaprepitant. Class-specific side effects For class-specific side effects (headache, constipation, wound infection, extrapyramidal symptoms, sedation, arrhythmia, and QT prolongation) of relevant substances, the certainty of evidence for the best and most reliable anti-vomiting drugs mostly ranged from very low to low. Exceptions were that ondansetron probably increases headache (RR 1.16, 95% CI 1.06 to 1.28, moderate certainty, rank 18/23) and probably reduces sedation (RR 0.87, 95% CI 0.79 to 0.96, moderate certainty, rank 5/24) compared to placebo. The latter effect is limited to recommended and high doses of ondansetron. Droperidol probably reduces headache (RR 0.76, 95% CI 0.67 to 0.86, moderate certainty, rank 5/23) compared to placebo. We have high-certainty evidence that dexamethasone (RR 1.00, 95% CI 0.91 to 1.09, high certainty, rank 16/24) has no effect on sedation compared to placebo. No studies assessed substance class-specific side effects for fosaprepitant. Direction and magnitude of network effect estimates together with level of evidence certainty are graphically summarized for all pre-defined GRADE-relevant outcomes and all drugs of direct interest compared to placebo in http://doi.org/10.5281/zenodo.4066353.
AUTHORS' CONCLUSIONS
We found high-certainty evidence that five single drugs (aprepitant, ramosetron, granisetron, dexamethasone, and ondansetron) reduce vomiting, and moderate-certainty evidence that two other single drugs (fosaprepitant and droperidol) probably reduce vomiting, compared to placebo. Four of the six substance classes (5-HT₃ receptor antagonists, D₂ receptor antagonists, NK₁ receptor antagonists, and corticosteroids) were thus represented by at least one drug with important benefit for prevention of vomiting. Combinations of drugs were generally more effective than the corresponding single drugs in preventing vomiting. NK₁ receptor antagonists were the most effective drug class and had comparable efficacy to most of the drug combinations. 5-HT₃ receptor antagonists were the best studied substance class. For most of the single drugs of direct interest, we found only very low to low certainty evidence for safety outcomes such as occurrence of SAEs, any AE, and substance class-specific side effects. Recommended and high doses of granisetron, dexamethasone, ondansetron, and droperidol were more effective than low doses for prevention of vomiting. Dose dependency of side effects was rarely found due to the limited number of studies, except for the less sedating effect of recommended and high doses of ondansetron. The results of the review are transferable mainly to patients at higher risk of nausea and vomiting (i.e. healthy women undergoing inhalational anaesthesia and receiving perioperative opioids). Overall study quality was limited, but certainty assessments of effect estimates consider this limitation. No further efficacy studies are needed as there is evidence of moderate to high certainty for seven single drugs with relevant benefit for prevention of vomiting. However, additional studies are needed to investigate potential side effects of these drugs and to examine higher-risk patient populations (e.g. individuals with diabetes and heart disease).",2020,"Droperidol probably reduces headache (RR 0.76, 95% CI 0.67 to 0.86, moderate certainty, rank 5/23) compared to placebo.","['585 studies (97,516 randomized participants', 'small (median sample size of 100); they were published between 1965 and 2017 and were primarily conducted in Asia (51%), Europe (25%), and North America (16', 'adults undergoing any type of surgery under general anaesthesia', 'adults after general anaesthesia', 'Frequency of any AE Sixty-one RCTs were included in the NMA for any AE (19,423 participants, 15 single drugs, and 11 drug combinations', '39 eligible studies were found that were not included in the analysis (listed as awaiting classification', 'healthy women undergoing inhalational anaesthesia and receiving perioperative opioids', 'adults undergoing any type of surgery under general anaesthesia •', 'Most participants were women (83%), had American Society of Anesthesiologists (ASA) physical status']","['placebo (inactive control', 'granisetron', 'Dexamethasone', 'perioperative opioids', 'droperidol', 'gastrointestinal surgery (19%) under general anaesthesia using volatile anaesthetics', 'dexamethasone', 'placebo', 'Granisetron', 'direct interest (amisulpride, aprepitant, casopitant, dexamethasone, dimenhydrinate, dolasetron, droperidol, fosaprepitant, granisetron, haloperidol, meclizine, methylprednisolone, metoclopramide, ondansetron, palonosetron, perphenazine, promethazine, ramosetron, rolapitant, scopolamine, and tropisetron', 'antiemetic drugs (monotherapy and combination prophylaxis', 'Droperidol', 'ramosetron, granisetron, dexamethasone, ondansetron, and droperidol', 'placebo, or against each other (as monotherapy or combination prophylaxis', 'prophylactic pharmacologic interventions (antiemetic drugs', 'ramosetron', 'NMA', 'Ondansetron', 'ramosetron, granisetron, dexamethasone, and ondansetron', 'ondansetron', 'granisetron, dexamethasone, ondansetron, and droperidol']","['reduce SAEs', 'headache', 'Vomiting', 'postoperative nausea and vomiting', 'vomiting within 24 hours postoperatively, serious adverse events (SAEs), and any adverse event (AE', 'efficacy and safety', 'nausea and vomiting', 'sedation', 'drug class-specific side effects (e.g. headache), mortality, early and late vomiting, nausea, and complete response', 'vomiting', 'efficacy and safety •', 'headache, constipation, wound infection, extrapyramidal symptoms, sedation, arrhythmia, and QT prolongation']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0069477', 'cui_str': 'NG-Monomethyl-L-Arginine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013162', 'cui_str': 'Drug Combinations'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0061863', 'cui_str': 'Granisetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013136', 'cui_str': 'Droperidol'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C2347566', 'cui_str': 'casopitant'}, {'cui': 'C0012381', 'cui_str': 'Dimenhydrinate'}, {'cui': 'C0209210', 'cui_str': 'Dolasetron'}, {'cui': 'C2349941', 'cui_str': 'fosaprepitant'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0025039', 'cui_str': 'Meclizine'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0031184', 'cui_str': 'Perphenazine'}, {'cui': 'C0033405', 'cui_str': 'Promethazine'}, {'cui': 'C0526950', 'cui_str': 'ramosetron'}, {'cui': 'C3273719', 'cui_str': 'rolapitant'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0063322', 'cui_str': 'tropisetron'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0069477', 'cui_str': 'NG-Monomethyl-L-Arginine'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}]",97516.0,0.375643,"Droperidol probably reduces headache (RR 0.76, 95% CI 0.67 to 0.86, moderate certainty, rank 5/23) compared to placebo.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Weibel', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Gerta', 'Initials': 'G', 'LastName': 'Rücker', 'Affiliation': 'Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center - University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Leopold Hj', 'Initials': 'LH', 'LastName': 'Eberhart', 'Affiliation': 'Department of Anaesthesiology & Intensive Care Medicine, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Nathan L', 'Initials': 'NL', 'LastName': 'Pace', 'Affiliation': 'Department of Anesthesiology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Hartl', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Olivia L', 'Initials': 'OL', 'LastName': 'Jordan', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Mayer', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Riemer', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Maximilian S', 'Initials': 'MS', 'LastName': 'Schaefer', 'Affiliation': 'Department of Anaesthesiology, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Raj', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Insa', 'Initials': 'I', 'LastName': 'Backhaus', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Helf', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schlesinger', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kienbaum', 'Affiliation': 'Department of Anaesthesiology, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kranke', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012859.pub2']
1316,33076229,"A Randomized Controlled Trial Testing the Effectiveness of Coping with Cancer in the Kitchen, a Nutrition Education Program for Cancer Survivors.","Following a diet rich in whole grains, vegetables, fruit, and beans may reduce cancer incidence and mortality. The aim of this study was to investigate the effect of Coping with Cancer in the Kitchen (CCK), an 8 week in-person program offering education, culinary demonstrations and food tasting, and psychosocial group support, compared to receiving CCK printed materials by mail on knowledge, confidence, and skills in implementing a plant-based diet. A total of 54 adult cancer survivors were randomly assigned to intervention ( n = 26) and control groups ( n = 27) with assessments at baseline, 9, and 15 weeks via self-administered survey. The response rate was 91% at 9 weeks and 58% at 15 weeks. The majority of our study participants were female breast cancer survivors (58%) who had overweight or obesity (65%). Compared with the control, there were significant ( p < 0.05) increases in intervention participants' knowledge about a plant-based diet at weeks 9 and 15, reductions in perceived barriers to eating more fruits and vegetables at week 9, and enhanced confidence and skills in preparing a plant-based diet at week 15. There was a significant reduction in processed meat intake but changes in other food groups and psychosocial measures were modest. Participation in CCK in person increased knowledge, skills, and confidence and reduced barriers to adopting a plant-based diet. Positive trends in intake of plant-based foods and quality of life warrant further investigation in larger-scale studies and diverse populations.",2020,"Compared with the control, there were significant ( p < 0.05) increases in intervention participants' knowledge about a plant-based diet at weeks 9 and 15, reductions in perceived barriers to eating more fruits and vegetables at week 9, and enhanced confidence and skills in preparing a plant-based diet at week 15.","['Cancer Survivors', 'participants were female breast cancer survivors (58%) who had overweight or obesity (65', '54 adult cancer survivors']",['Coping with Cancer in the Kitchen (CCK'],"['processed meat intake', 'response rate', 'cancer incidence and mortality']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0557653', 'cui_str': 'Kitchen'}]","[{'cui': 'C0556213', 'cui_str': 'Processed meat intake'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",54.0,0.0413395,"Compared with the control, there were significant ( p < 0.05) increases in intervention participants' knowledge about a plant-based diet at weeks 9 and 15, reductions in perceived barriers to eating more fruits and vegetables at week 9, and enhanced confidence and skills in preparing a plant-based diet at week 15.","[{'ForeName': 'Melissa Farmer', 'Initials': 'MF', 'LastName': 'Miller', 'Affiliation': 'Department of Public Health, College of Health Sciences, Arcadia University, Glenside, PA 19038, USA.'}, {'ForeName': 'Zhongyu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Habedank', 'Affiliation': 'American Institute for Cancer Research, Arlington, VA 22209, USA.'}]",Nutrients,['10.3390/nu12103144']
1317,33076263,Carbohydrate-Induced Insulin Signaling Activates Focal Adhesion Kinase: A Nutrient and Mechanotransduction Crossroads.,"Research has suggested that nutrient, exercise, and metabolism-related proteins interact to regulate mammalian target of rapamycin complex one (mTOR) post-exercise and their interactions needs clarification. In a double-blind, cross-over, repeated measures design, ten participants completed four sets to failure at 70% of 1-repitition maximum (1-RM) with 45 s rest on angled leg press with or without pre-exercise maltodextrin (2 g/kg) after a 3 h fast. Vastus lateralis biopsies were collected at baseline before supplementation and 1 h post-exercise to analyze Focal Adhesion Kinase (FAK), ribosomal protein S6 kinase beta-1 (p70S6K), insulin receptor substrate 1 (IRS-1), phosphatidylinositol 3-kinase (PI3K), and 5' AMP-activated protein kinase (AMPK) activation. FAK and IRS-1 activity were only elevated 1 h post-exercise with carbohydrate ingestion ( p < 0.05). PI3K and p70S6K activation were both elevated after exercise in both conditions ( p < 0.05). However, AMPK activity did not change from baseline in both conditions ( p > 0.05). We conclude that FAK does not induce mTOR activation through PI3K crosstalk in response to exercise alone. In addition, FAK may not be regulated by AMPK catalytic activity, but this needs further research. Interestingly, carbohydrate-induced insulin signaling appears to activate FAK at the level of IRS-1 but did not enhance mTOR activity 1 h post-exercise greater than the placebo condition. Future research should investigate these interactions under different conditions and within different time frames to clearly understand the interactions between these signaling molecules.",2020,FAK and IRS-1 activity were only elevated 1 h post-exercise with carbohydrate ingestion ( p < 0.05).,[],"['FAK', 'Carbohydrate-Induced Insulin Signaling Activates Focal Adhesion Kinase', '1-repitition maximum (1-RM) with 45 s rest on angled leg press with or without pre-exercise maltodextrin']","['AMPK activity', 'mTOR activity', 'PI3K and p70S6K activation', 'Focal Adhesion Kinase (FAK), ribosomal protein S6 kinase beta-1 (p70S6K), insulin receptor substrate 1 (IRS-1), phosphatidylinositol 3-kinase', ""PI3K), and 5' AMP-activated protein kinase (AMPK) activation"", 'FAK and IRS-1 activity']",[],"[{'cui': 'C0059239', 'cui_str': 'Endogenous Substrate pp120'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C2350345', 'cui_str': 'AMP-Activated Protein Kinase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0293060', 'cui_str': 'FKBP12-Rapamycin Associated Protein'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0044602', 'cui_str': '1-phosphatidylinositol 3-kinase'}, {'cui': 'C1136240', 'cui_str': 'p70 S6 Kinase'}, {'cui': 'C0059239', 'cui_str': 'Endogenous Substrate pp120'}, {'cui': 'C2827383', 'cui_str': 'ribosomal protein S6 kinase beta 1'}, {'cui': 'C0123658', 'cui_str': 'Insulin Receptor Substrate-1'}]",10.0,0.113269,FAK and IRS-1 activity were only elevated 1 h post-exercise with carbohydrate ingestion ( p < 0.05).,"[{'ForeName': 'Dylan T', 'Initials': 'DT', 'LastName': 'Wilburn', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Waco, TX 76706, USA.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Machek', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Waco, TX 76706, USA.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Cardaci', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Waco, TX 76706, USA.'}, {'ForeName': 'Darryn S', 'Initials': 'DS', 'LastName': 'Willoughby', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Waco, TX 76706, USA.'}]",Nutrients,['10.3390/nu12103145']
1318,33084088,Cerebral effects of glucagon-like peptide-1 receptor blockade before and after Roux-en-Y gastric bypass surgery in obese women: A proof-of-concept resting-state functional MRI study.,"AIM
To assess the effects of Roux-en-Y gastric bypass surgery (RYGB)-related changes in glucagon-like peptide-1 (GLP-1) on cerebral resting-state functioning in obese women.
MATERIALS AND METHODS
In nine obese females aged 40-54 years in the fasted state, we studied the effects of RYGB and GLP-1 on five a priori selected networks implicated in food- and reward-related processes as well as environment monitoring (default mode, right frontoparietal, basal ganglia, insula/anterior cingulate and anterior cingulate/orbitofrontal networks).
RESULTS
Before surgery, GLP-1 receptor blockade (using exendin9-39) was associated with increased right caudate nucleus (basal ganglia network) and decreased right middle frontal (right frontoparietal network) connectivity compared with placebo. RYGB resulted in decreased right orbitofrontal (insula/anterior cingulate network) connectivity. In the default mode network, after surgery, GLP-1 receptor blockade had a larger effect on connectivity in this region than GLP-1 receptor blockade before RYGB (all P FWE < .05). Results remained similar after correction for changes in body weight. Default mode and right frontoparietal network connectivity changes were related to changes in body mass index and food scores after RYGB.
CONCLUSIONS
These findings suggest GLP-1 involvement in resting-state networks related to food and reward processes and monitoring of the internal and external environment, pointing to a potential role for GLP-1-induced changes in resting-state connectivity in RYGB-mediated weight loss and appetite control.",2020,"Default mode and right frontoparietal network connectivity changes were related to changes in BMI and food scores after RYGB.
","['obese women', '9 middle-aged obese females']","['GLP-1 receptor blockade', 'Roux-en-Y Gastric Bypass', 'Roux-en-Y Gastric Bypass (RYGB', 'RYGB', 'placebo']","['BMI and food scores', 'right caudate nucleus (basal ganglia network) and decreased right middle frontal (right frontoparietal network) connectivity', 'body weight', 'right orbitofrontal (insula/anterior cingulate network) connectivity', 'glucagon-like peptide-1']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C0378073', 'cui_str': 'GLP-1R Receptor'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0007461', 'cui_str': 'Caudate nucleus structure'}, {'cui': 'C0004781', 'cui_str': 'Basal ganglion structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",,0.0226995,"Default mode and right frontoparietal network connectivity changes were related to changes in BMI and food scores after RYGB.
","[{'ForeName': 'Eelco', 'Initials': 'E', 'LastName': 'van Duinkerken', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Bernardes', 'Affiliation': 'Departament of Psychology, Pontifícia Universidade Católica do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Liselotte', 'Initials': 'L', 'LastName': 'van Bloemendaal', 'Affiliation': 'Amsterdam Diabetes Center/Department of Internal Medicine, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Dick J', 'Initials': 'DJ', 'LastName': 'Veltman', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Barkhof', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Mograbi', 'Affiliation': 'Departament of Psychology, Pontifícia Universidade Católica do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Victor E A', 'Initials': 'VEA', 'LastName': 'Gerdes', 'Affiliation': 'Department of Internal Medicine, Spaarne Gasthuis, Hoofddorp, the Netherlands.'}, {'ForeName': 'Carolyn F', 'Initials': 'CF', 'LastName': 'Deacon', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research and Department of Biomedical Sciences, Panum Institute, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research and Department of Biomedical Sciences, Panum Institute, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Madeleine L', 'Initials': 'ML', 'LastName': 'Drent', 'Affiliation': 'Amsterdam Diabetes Center/Department of Internal Medicine, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Diamant', 'Affiliation': 'Amsterdam Diabetes Center/Department of Internal Medicine, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ten Kulve', 'Affiliation': 'Amsterdam Diabetes Center/Department of Internal Medicine, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Ijzerman', 'Affiliation': 'Amsterdam Diabetes Center/Department of Internal Medicine, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14233']
1319,33085088,Minimally invasive parathyroidectomy guided by intraoperative parathyroid hormone monitoring (IOPTH) and preoperative imaging versus bilateral neck exploration for primary hyperparathyroidism in adults.,"BACKGROUND
Bilateral neck exploration (BNE) is the traditional approach to sporadic primary hyperparathyroidism. With the availability of the preoperative imaging techniques and intraoperative parathyroid hormone assays, minimally invasive parathyroidectomy (MIP) is fast becoming the favoured surgical approach.
OBJECTIVES
To assess the effects of minimally invasive parathyroidectomy (MIP) guided by preoperative imaging and intraoperative parathyroid hormone monitoring versus bilateral neck exploration (BNE) for the surgical management of primary hyperparathyroidism.
SEARCH METHODS
We searched CENTRAL, MEDLINE, WHO ICTRP and ClinicalTrials.gov. The date of the last search of all databases was 21 October 2019. There were no language restrictions applied.
SELECTION CRITERIA
We included randomised controlled trials comparing MIP to BNE for the treatment of sporadic primary hyperparathyroidism in persons undergoing surgery for the first time.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened titles and abstracts for relevance. Two review authors independently screened for inclusion, extracted data and carried out risk of bias assessment. The content expert senior author resolved conflicts. We assessed studies for overall certainty of the evidence using the GRADE instrument. We conducted meta-analyses using a random-effects model and performed statistical analyses according to the guidelines in the latest version of the Cochrane Handbook for Systematic Reviews of Interventions.
MAIN RESULTS
We identified five eligible studies, all conducted in European university hospitals. They included 266 adults, 136 participants were randomised to MIP and 130 participants to BNE. Data were available for all participants post-surgery up to one year, with the exception of missing data for two participants in the MIP group and for one participant in the BNE group at one year. Nine participants in the MIP group and 11 participants in the BNE group had missing data at five years. No study had a low risk of bias in all risk of bias domains. The risk ratio (RR) for success rate (eucalcaemia) at six months in the MIP group compared to the BNE group was 0.98 (95% confidence interval (CI) 0.94 to 1.03; P = 0.43; 5 studies, 266 participants; very low-certainty evidence). A total of 132/136 (97.1%) participants in the MIP group compared with 129/130 (99.2%) participants in the BNE group were judged as operative success. At five years, the RR was 0.94 (95% CI 0.83 to 1.08; P = 0.38; 1 study, 77 participants; very low-certainty evidence). A total of 34/38 (89.5%) participants in the MIP group compared with 37/39 (94.9%) participants in the BNE group were judged as operative success. The RR for the total incidence of perioperative adverse events was 0.50, in favour of MIP (95% CI 0.33 to 0.76; P = 0.001; 5 studies, 236 participants; low-certainty evidence). Perioperative adverse events occurred in 23/136 (16.9%) participants in the MIP group compared with 44/130 (33.9%) participants in the BNE group. The 95% prediction interval ranged between 0.25 and 0.99. These adverse events included symptomatic hypocalcaemia, vocal cord palsy, bleeding, fever and infection. Fifteen of 104 (14.4%) participants experienced symptomatic hypocalcaemia in the MIP group compared with 26/98 (26.5%) participants in the BNE group. The RR for this event comparing MIP with BNE at two days was 0.54 (95% CI 0.32 to 0.92; P = 0.02; 4 studies, 202 participants). Statistical significance was lost in sensitivity analyses, with a 95% prediction interval ranging between 0.17 and 1.74. Five out of 133 (3.8%) participants in the MIP group experienced vocal cord paralysis compared with 2/128 (1.6%) participants in the BNE group. The RR for this event was 1.87 (95% CI 0.47 to 7.51; P = 0.38; 5 studies, 261 participants). The 95% prediction interval ranged between 0.20 and 17.87. The effect on all-cause mortality was not explicitly reported and could not be adequately assessed (very low-certainty evidence). There was no clear difference for health-related quality of life between the treatment groups in two studies, but studies did not report numerical data (very low-certainty evidence). There was a possible treatment benefit for MIP compared to BNE in terms of cosmetic satisfaction (very low-certainty evidence). The mean difference (MD) for duration of surgery comparing BNE with MIP was in favour of the MIP group (-18 minutes, 95% CI -31 to -6; P = 0.004; 3 studies, 171 participants; very low-certainty evidence). The 95% prediction interval ranged between -162 minutes and 126 minutes. The studies did not report length of hospital stay. Four studies reported intraoperative conversion rate from MIP to open procedure information. Out of 115 included participants, there were 24 incidences of conversion, amounting to a conversion rate of 20.8%.
AUTHORS' CONCLUSIONS
The success rates of MIP and BNE at six months were comparable. There were similar results at five years, but these were only based on one study. The incidence of perioperative symptomatic hypocalcaemia was lower in the MIP compared to the BNE group, whereas the incidence of vocal cord paralysis tended to be higher. Our systematic review did not provide clear evidence for the superiority of MIP over BNE. However, it was limited by low-certainty to very low-certainty evidence.",2020,There was a possible treatment benefit for MIP compared to BNE in terms of cosmetic satisfaction (very low-certainty evidence).,"['Nine participants in the MIP group and 11 participants in the BNE group had missing data at five years', 'They included 266 adults, 136 participants were randomised to MIP and 130 participants to BNE', 'primary hyperparathyroidism in adults', 'persons undergoing surgery for the first time']","['MIP to BNE', 'Minimally invasive parathyroidectomy guided by intraoperative parathyroid hormone monitoring (IOPTH) and preoperative imaging versus bilateral neck exploration', 'Bilateral neck exploration (BNE', 'minimally invasive parathyroidectomy (MIP) guided by preoperative imaging and intraoperative parathyroid hormone monitoring versus bilateral neck exploration (BNE']","['total incidence of perioperative adverse events', 'vocal cord paralysis', 'operative success', 'risk ratio (RR) for success rate (eucalcaemia', 'health-related quality of life', 'cosmetic satisfaction', 'success rates of MIP and BNE', 'symptomatic hypocalcaemia', 'Perioperative adverse events', 'symptomatic hypocalcaemia, vocal cord palsy, bleeding, fever and infection', 'perioperative symptomatic hypocalcaemia']","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1096695', 'cui_str': 'Neck exploration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0221002', 'cui_str': 'Primary hyperparathyroidism'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1096695', 'cui_str': 'Neck exploration'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042928', 'cui_str': 'Vocal cord paralysis'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1096695', 'cui_str': 'Neck exploration'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",136.0,0.208146,There was a possible treatment benefit for MIP compared to BNE in terms of cosmetic satisfaction (very low-certainty evidence).,"[{'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Ahmadieh', 'Affiliation': 'Department of Internal Medicine, Beirut Arab University, Beirut, Lebanon.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Kreidieh', 'Affiliation': ""Department of Medicine, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston MA, Massachusetts, USA.""}, {'ForeName': 'Elie A', 'Initials': 'EA', 'LastName': 'Akl', 'Affiliation': 'Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'El-Hajj Fuleihan', 'Affiliation': 'Department of Internal Medicine, Calcium Metabolism and Osteoporosis Program, WHO Collaborating Center for Metabolic Bone Disorders, Division of Endocrinology, American University of Beirut Medical Centre, Beirut, Lebanon.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010787.pub2']
1320,33080728,Uniportal versus multiportal thoracoscopic lobectomy: Ergonomic evaluation and perioperative outcomes from a randomized and controlled trial.,"BACKGROUND
To compare perioperative outcomes and surgeon physical and mental stress when performing lobectomy through uniportal and multiportal video-assisted thoracoscopic surgery (VATS) on patients with non-small-cell lung cancer (NSCLC).
METHODS
Patients aged 41 to 73 years with resectable NSCLC were randomly assigned via a computer-generated randomisation sequence to receive either uniportal VATS (UVATS) or multiportal VATS (MVATS) lobectomy and lymphadenectomy between December 2015 and October 2016. Overall, we randomly assigned 35 patients to the UVATS and 34 to the MVATS group. Patients and the investigators undertaking interventions, assessing short-term outcomes, performing ergonomic evaluations, and analyzing data were not masked to group assignment.
RESULTS
Patient demographics of the 2 groups were comparable. The ergonomic evaluation considered eye blink rate and the NASA Task Load Index (NASA-TLX), better results were observed in UVATS than in MVATS. The operative time, number of lymph nodes harvested, chest tube duration, length of hospital stay, and lung function were not significantly different between the groups. Compared with MVATS lobectomy, UVATS lobectomy was associated with less intraoperative blood loss and less volume of total drainage in the 24 hours. No conversion, no reoperation, and no in-hospital mortality occurred in either group.
CONCLUSIONS
UVATS lobectomy is a safe and programmable technique with some better perioperative outcomes and ergonomic results than MVATS. Further studies based on large numbers of patients and with long-term follow-up are required to confirm its benefits towards patients.
TRIAL REGISTRATION
ClinicalTrials.gov ID:NCT02462356. Registered May 27, 2015.",2020,"Compared with MVATS lobectomy, UVATS lobectomy was associated with less intraoperative blood loss and less volume of total drainage in the 24 hours.","['Patients aged 41 to 73 years with resectable NSCLC', 'patients with non-small-cell lung cancer (NSCLC']","['uniportal VATS (UVATS) or multiportal VATS (MVATS) lobectomy and lymphadenectomy', 'MVATS lobectomy, UVATS lobectomy', 'lobectomy through uniportal and multiportal video-assisted thoracoscopic surgery (VATS', 'Uniportal versus multiportal thoracoscopic lobectomy', 'UVATS lobectomy']","['eye blink rate and the NASA Task Load Index (NASA-TLX', 'hospital mortality', 'intraoperative blood loss and less volume of total drainage', 'operative time, number of lymph nodes harvested, chest tube duration, length of hospital stay, and lung function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C4304660', 'cui_str': 'Uniportal VATS - video assisted thoracoscopic surgery'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C0242776', 'cui_str': 'National Aeronautics and Space Administration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",35.0,0.0965214,"Compared with MVATS lobectomy, UVATS lobectomy was associated with less intraoperative blood loss and less volume of total drainage in the 24 hours.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Department of Thoracic Surgery, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, China.'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Junqiang', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022719']
1321,33080730,Effects of positive dispatcher encouragement on the maintenance of bystander cardiopulmonary resuscitation quality.,"BACKGROUND
Implementation of dispatcher-assisted cardiopulmonary resuscitation (DACPR) has increased the likelihood of bystander CPR upon cardiac arrest. However, the quality of CPR has been found to be very low. In this study, we aimed to compare CPR quality between the current DACPR practices and the interventional instruction of adding verbal encouragement from the dispatcher.
METHODS
In this randomized controlled trial, we recruited adult (age ≥18) laypersons who were non-health care providers and had never received any previous verified CPR training. They were randomly selected to perform DACPR using metronome sounds (mDACPR) as per the standard protocol, or DACPR with metronome sounds along with human encouragement (mheDACPR). The ratio of accurate compression rate, depth, and complete release for each CPR phase was examined.
RESULTS
Sixty nine records (34, mDACPR; 35, mheDACPR) were taken. The median proportion of accurate chest compression rate was initially 29.5% with mDACPR, and significantly increased to 71% after 2 minutes of CPR administration (P = .046). However, the median ratio of accurate chest compression depth was 61.5% in the first phase, and significantly decreased to 0% in the last phase (P < .001). In contrast, for the mheDACPR group, a high accurate compression rate was maintained throughout the 2 minutes of CPR administration (91%, 100%, 100%, 100%).
CONCLUSION
To maintain the quality of CPR administered by bystanders, continuous feedback and repeated human encouragement should be provided during DACPR. Active dispatcher intervention reduces the time required to reach an appropriate CPR rate and allows for the maintenance of accurate compression rates.",2020,Active dispatcher intervention reduces the time required to reach an appropriate CPR rate and allows for the maintenance of accurate compression rates.,['recruited adult (age ≥18) laypersons who were non-health care providers and had never received any previous verified CPR training'],"['dispatcher-assisted cardiopulmonary resuscitation (DACPR', 'DACPR using metronome sounds (mDACPR) as per the standard protocol, or DACPR with metronome sounds along with human encouragement (mheDACPR', 'positive dispatcher encouragement', 'Active dispatcher intervention']","['accurate compression rate', 'median proportion of accurate chest compression rate', 'median ratio of accurate chest compression depth', 'bystander cardiopulmonary resuscitation quality', 'ratio of accurate compression rate, depth, and complete release', 'time required to reach an appropriate CPR rate', 'CPR quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]",,0.0236743,Active dispatcher intervention reduces the time required to reach an appropriate CPR rate and allows for the maintenance of accurate compression rates.,"[{'ForeName': 'Bo Na', 'Initials': 'BN', 'LastName': 'Hwang', 'Affiliation': 'Emergency Medicine Research Foundation, Seoul.'}, {'ForeName': 'Eun Hae', 'Initials': 'EH', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Hang A', 'Initials': 'HA', 'LastName': 'Park', 'Affiliation': 'Department of Emergency Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Ju Ok', 'Initials': 'JO', 'LastName': 'Park', 'Affiliation': 'Department of Emergency Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Choung Ah', 'Initials': 'CA', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Gyeonggi-do, Korea.'}]",Medicine,['10.1097/MD.0000000000022728']
1322,33080734,Will purposely seeking detect more colorectal polyps than routine performing during colonoscopy?,"BACKGROUND & GOALS
We observed that the number of colorectal polyps found intraoperatively was often higher than that encountered preoperatively during elective colonoscopic polypectomy. To evaluate whether more polyps can be detected when they are purposely sought than when they are routinely examined during colonoscopy.
MATERIALS AND METHODS
Patients undergoing colonoscopy were randomized into groups A and B. Before colonoscopy was performed, endoscopists were instructed to seek polyps for group A purposely but not for group B. Polypectomy was electively completed. In groups A and B, the cases of elective polypectomy were named groups AR and BR, including groups AR-1 and BR-1, during the first colonoscopy and groups AR-2 and BR-2 during the second colonoscopy for polypectomy, respectively. The following data were calculated: the number of polyps detected (NPD) and the polyp detection rate (PDR) in all cases and the number of polyps missed (NPM) and partial polyp miss rate (PPMR) in the cases of colorectal polyps.
RESULTS
A total of 419 cases were included in group A, 421 in group B, 43 in group AR, and 35 in group BR. No significant differences in PDR were found between groups A and B and in PPMR between groups AR-1 and BR-1 (P > .05), although PPMR in group AR-1 was higher than in group AR-2 (P < .05), similar results were found in PPMR between groups BR-1 and BR-2 (P < .05).
CONCLUSION
Purposely seeking for colorectal polyps did not result in more polyps detected compared with routine colonoscopy.",2020,"No significant differences in PDR were found between groups A and B and in PPMR between groups AR-1 and BR-1 (P > .05), although PPMR in group AR-1 was higher than in group AR-2 (P < .05), similar results were found in PPMR between groups BR-1 and BR-2 (P < .05).
","['Patients undergoing colonoscopy', 'A total of 419 cases were included in group A, 421 in group B, 43 in group AR, and 35 in group BR']",[],"['PPMR in group AR-1', 'number of polyps missed (NPM) and partial polyp miss rate (PPMR', 'number of polyps detected (NPD) and the polyp detection rate (PDR', 'PDR', 'PPMR between groups BR-1 and BR-2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0103931', 'cui_str': 'AR-1'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",419.0,0.0195262,"No significant differences in PDR were found between groups A and B and in PPMR between groups AR-1 and BR-1 (P > .05), although PPMR in group AR-1 was higher than in group AR-2 (P < .05), similar results were found in PPMR between groups BR-1 and BR-2 (P < .05).
","[{'ForeName': 'Yanliu', 'Initials': 'Y', 'LastName': 'Chu', 'Affiliation': 'Department of Hepatology and Gastroenterology, Chinese PLA General Hospital, Beijing.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Shuyi', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Qinfu', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Qiao', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Zhenhe', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Heye', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yue', 'Affiliation': 'Department of Gastroenterology, Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, Weihai, Shandong Province, China.'}, {'ForeName': 'Enqiang', 'Initials': 'E', 'LastName': 'Linghu', 'Affiliation': 'Department of Hepatology and Gastroenterology, Chinese PLA General Hospital, Beijing.'}]",Medicine,['10.1097/MD.0000000000022738']
1323,33081715,The MIPAM trial: a 12-week intervention with motivational interviewing and physical activity monitoring to enhance the daily amount of physical activity in community-dwelling older adults - a study protocol for a randomized controlled trial.,"BACKGROUND
Physical Activity Monitors (PAMs) have been shown to effectively enhance level of physical activity (PA) in older adults. Motivational interviewing is a person-centred model where participants are guided using self-reflection and counselling, and addresses the behavioural and psychological aspects of why people initiate health behaviour change by prompting increases in motivation and self-efficacy. The addition of motivational interviewing to PA interventions may increase the effectiveness of PAMs for older adults.
METHODS
This motivational interviewing and PA monitoring trial is designed as an investigator-blinded, two arm parallel group, randomized controlled superiority trial with primary endpoint after 12 weeks of intervention. The intervention group will receive a PAM-based intervention and motivational interviewing and the control group will only receive the PAM-based intervention. The primary outcome is PA, objectively measured as the average daily number of steps throughout the intervention period. Secondary outcome measures include self-reported PA health-related quality of life, loneliness, self-efficacy for exercise, outcome expectancy for exercise, and social relations. The outcomes will be analysed with a linear regression model investigating between-group differences, adjusted for baseline scores. Following the intention to treat principle, multiple imputation will be performed to handle missing values.
DISCUSSION
A moderate effect of daily PA measured using PAMs is expected in this superiority RCT investigating the effect of adding motivational interviewing to a PAM intervention. According to the World Health Organization, walking and cycling are key activities in regular PA and should be promoted. To increase the general public health and lower the burden of inactivity in older adults, cost-beneficial solutions should be investigated further. If this RCT shows that motivational interviewing can enhance the effect of PAM-based interventions, it might be included as an add-on intervention when appropriate. No matter what the results of this study will be, the conclusions will be relevant for clinicians as the dependence on technology is increasing, especially in relation to public health promotion.
TRIAL REGISTRATION
NCT03906162 , April 1, 2019.",2020,"Secondary outcome measures include self-reported PA health-related quality of life, loneliness, self-efficacy for exercise, outcome expectancy for exercise, and social relations.","['older adults', 'community-dwelling older adults']","['Physical Activity Monitors (PAMs', 'motivational interviewing and physical activity monitoring to enhance the daily amount of physical activity', 'Motivational interviewing', 'PAM-based intervention and motivational interviewing and the control group will only receive the PAM-based intervention', 'motivational interviewing to PA interventions']","['general public health', 'PA, objectively measured as the average daily number of steps', 'self-reported PA health-related quality of life, loneliness, self-efficacy for exercise, outcome expectancy for exercise, and social relations']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2931826', 'cui_str': 'Potassium aggravated myotonia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0699643,"Secondary outcome measures include self-reported PA health-related quality of life, loneliness, self-efficacy for exercise, outcome expectancy for exercise, and social relations.","[{'ForeName': 'Rasmus Tolstrup', 'Initials': 'RT', 'LastName': 'Larsen', 'Affiliation': 'Department of Public Health, Section of Social Medicine, University of Copenhagen, Copenhagen, Denmark. rala@sund.ku.dk.'}, {'ForeName': 'Christoffer Bruun', 'Initials': 'CB', 'LastName': 'Korfitsen', 'Affiliation': 'Department of Public Health, Section of Social Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Carsten Bogh', 'Initials': 'CB', 'LastName': 'Juhl', 'Affiliation': 'Research Unit of Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Henning Boje', 'Initials': 'HB', 'LastName': 'Andersen', 'Affiliation': 'Technical University of Denmark, DTU Management Engineering Inst, Lyngby, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Christensen', 'Affiliation': 'Department of Occupational- and Physiotherapy, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Langberg', 'Affiliation': 'Department of Public Health, Section for Health Services Research, University of Copenhagen, Copenhagen, Denmark.'}]",BMC geriatrics,['10.1186/s12877-020-01815-1']
1324,33082191,(Rad 8)Caffeine prophylaxis to improve intermittent hypoxaemia in infants born late preterm: a randomised controlled dosage trial (Latte Dosage Trial).,"INTRODUCTION
Infants born late preterm (34+0 to 36+6 weeks' gestational age) have frequent episodes of intermittent hypoxaemia compared with term infants. Caffeine citrate reduces apnoea and intermittent hypoxaemia and improves long-term neurodevelopmental outcomes in infants born very preterm and may have similar effects in late preterm infants. Clearance of caffeine citrate increases with gestational age and late preterm infants are likely to need a higher dose than very preterm infants. Our aim is to determine the most effective and best-tolerated dose of caffeine citrate to reduce transient intermittent hypoxaemia events in late preterm infants.
METHODS AND ANALYSIS
A phase IIB, double-blind, five-arm, parallel, randomised controlled trial to compare the effect of four doses of oral caffeine citrate versus placebo on the frequency of intermittent hypoxaemia. Late preterm infants will be enrolled within 72 hours of birth and randomised to receive 5, 10, 15 or 20 mg/kg/day caffeine citrate or matching placebo daily until term corrected age. The frequency of intermittent hypoxaemia (events/hour where oxygen saturation concentration is ≥10% below baseline for ≤2 min) will be assessed with overnight oximetry at baseline, 2 weeks after randomisation (primary outcome) and at term corrected age. Growth will be measured at these timepoints, and effects on feeding and sleeping will be assessed by parental report. Data will be analysed using generalised linear mixed models.
ETHICS AND DISSEMINATION
This trial has been approved by the Health and Disability Ethics Committees of New Zealand (reference 18/NTA/129) and the local institutional research review committees. Findings will be disseminated to peer-reviewed journals to clinicians and researchers at local and international conferences and to the public. The findings of the trial will inform the design of a large multicentre trial of prophylactic caffeine in late preterm infants, by indicating the most appropriate dose to use and providing information on feasibility.
TRIAL REGISTRATION NUMBER
ACTRN12618001745235; Pre-results.",2020,Caffeine citrate reduces apnoea and intermittent hypoxaemia and improves long-term neurodevelopmental outcomes in infants born very preterm and may have similar effects in late preterm infants.,"['Late preterm infants', 'late preterm infants', 'infants born late preterm', 'infants born very preterm']","['8)Caffeine prophylaxis', 'Caffeine citrate', 'caffeine citrate or matching placebo', 'oral caffeine citrate versus placebo', 'caffeine citrate', 'prophylactic caffeine']","['intermittent hypoxaemia', 'frequency of intermittent hypoxaemia (events/hour where oxygen saturation concentration', 'apnoea and intermittent hypoxaemia and improves long-term neurodevelopmental outcomes', 'frequency of intermittent hypoxaemia', 'transient intermittent hypoxaemia events']","[{'cui': 'C3898619', 'cui_str': 'Late preterm infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0054436', 'cui_str': 'Caffeine citrate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040704', 'cui_str': 'Transients'}]",,0.496593,Caffeine citrate reduces apnoea and intermittent hypoxaemia and improves long-term neurodevelopmental outcomes in infants born very preterm and may have similar effects in late preterm infants.,"[{'ForeName': 'Elizabeth Anne', 'Initials': 'EA', 'LastName': 'Oliphant', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand e.oliphant@auckland.ac.nz.'}, {'ForeName': 'Christopher J D', 'Initials': 'CJD', 'LastName': 'McKinlay', 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'McNamara', 'Affiliation': ""Paediatrics Respiratory Services, Starship Children's Health, Auckland District Health Board, Auckland, New Zealand.""}, {'ForeName': 'Jane Marie', 'Initials': 'JM', 'LastName': 'Alsweiler', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}]",BMJ open,['10.1136/bmjopen-2020-038271']
1325,33085647,"Repetitive transcranial magnetic stimulation of the cerebellum improves ataxia and cerebello-fronto plasticity in multiple system atrophy: a randomized, double-blind, sham-controlled and TMS-EEG study.","Cerebellar ataxia is the predominant motor feature of multiple system atrophy cerebellar subtype (MSA-C). Although repetitive transcranial magnetic stimulation (TMS) of the cerebellum is growingly applied in MSA, the mechanism is unknown. We examined dynamic connectivity changes of 20 patients with MSA and 25 healthy controls using TMS combined with electroencephalography. Observations that significantly decreased dynamic cerebello-frontal connectivity in patients have inspired attempts to modulate cerebellar connectivity in order to benefit MSA. We further explore the therapeutic potential of a 10-day treatment of cerebellar intermittent theta burst stimulation (iTBS) in MSA by a randomized, double-blind, sham-controlled trial. The functional reorganization of cerebellar networks was investigated after the end of treatment in active and sham groups. The severity of the symptoms was evaluated using the Scale for Assessment and Rating of Ataxia scores. Patients treated with active stimulation showed an improvement of cerebello-frontal connectivity and balance functions, as revealed by a significant decrease in the ataxia scores (P < 0.01). Importantly, the neural activity of frontal connectivity from 80 to 100 ms after a single TMS was significantly related to the severity of the disease. Our study provides new proof that cerebellar iTBS improves motor imbalance in MSA by acting on cerebello-cortical plasticity.",2020,"Patients treated with active stimulation showed an improvement of cerebello-frontal connectivity and balance functions, as revealed by a significant decrease in the ataxia scores (P < 0.01).","['20 patients with MSA and 25 healthy controls using', 'multiple system atrophy']","['repetitive transcranial magnetic stimulation (TMS', 'Repetitive transcranial magnetic stimulation', 'cerebellar intermittent theta burst stimulation (iTBS', 'TMS combined with electroencephalography']","['ataxia scores', 'functional reorganization of cerebellar networks', 'Scale for Assessment and Rating of Ataxia scores', 'neural activity of frontal connectivity', 'cerebello-frontal connectivity and balance functions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000294', 'cui_str': 'Mesna'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0393571', 'cui_str': 'Multiple system atrophy'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.100909,"Patients treated with active stimulation showed an improvement of cerebello-frontal connectivity and balance functions, as revealed by a significant decrease in the ataxia scores (P < 0.01).","[{'ForeName': 'Penghui', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Siran', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Suobin', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}]",Aging,['10.18632/aging.103946']
1326,33086239,Greater Conditioned Pain Modulation Is Associated With Enhanced Morphine Analgesia in Healthy Individuals and Patients with Chronic Low Back Pain.,"OBJECTIVES
Conditioned pain modulation (CPM) protocols index magnitude of descending pain inhibition. This study evaluated whether degree of CPM, controlling for CPM expectancy confounds, was associated with analgesic and subjective responses to morphine, and whether chronic pain status or sex moderated these effects.
METHODS
Participants included 92 individuals with chronic low back pain (CLBP) and 99 healthy controls, none using daily opioid analgesics. In a crossover design, participants attended two identical laboratory sessions during which they received either intravenous morphine (0.08▒mg/kg) or saline placebo before undergoing evoked pain assessment. In each session, participants engaged in ischemic forearm and heat pain tasks, and a CPM protocol combining ischemic pain (conditioning stimulus) and heat pain (test stimulus). Placebo-controlled morphine outcomes were derived as differences in pain and subjective effects across drug conditions.
RESULTS
In hierarchical regressions controlling for CPM expectancies, greater placebo condition CPM was associated with less subjective morphine unpleasantness (P=0.001) and greater morphine analgesia (P's<0.05) on both the ischemic pain task (VAS Pain Intensity and Unpleasantness) and heat pain task (VAS Pain Intensity, McGill Pain Questionnaire-Sensory and Present Pain Intensity [PPI] subscales). There was no moderation by sex or CLBP status, except for the ischemic PPI outcome for which a significant 2-way interaction (P<0.05) was noted, with men showing a stronger positive relationship between CPM and morphine analgesia than women.
DISCUSSION
Result suggest that CPM might predict analgesic and subjective responses to opioid administration. Further evaluation of CPM as an element of precision pain medicine algorithms may be warranted.",2020,"In hierarchical regressions controlling for CPM expectancies, greater placebo condition CPM was associated with less subjective morphine unpleasantness (P=0.001) and greater morphine analgesia (P's<0.05) on both the ischemic pain task (VAS Pain Intensity and Unpleasantness) and heat pain task (VAS Pain Intensity, McGill Pain Questionnaire-Sensory and Present Pain Intensity [PPI] subscales).","['Healthy Individuals and Patients with Chronic Low Back Pain', 'Participants included 92 individuals with chronic low back pain (CLBP) and 99 healthy controls, none using daily opioid analgesics']","['saline placebo', 'intravenous morphine', 'Placebo-controlled morphine', 'morphine', 'CPM protocol combining ischemic pain (conditioning stimulus) and heat pain (test stimulus', 'Morphine Analgesia']","['pain and subjective effects', 'subjective morphine unpleasantness', 'ischemic pain task (VAS Pain Intensity and Unpleasantness) and heat pain task (VAS Pain Intensity, McGill Pain Questionnaire-Sensory and Present Pain Intensity [PPI] subscales', 'ischemic PPI outcome']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445114', 'cui_str': 'None used'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",92.0,0.20887,"In hierarchical regressions controlling for CPM expectancies, greater placebo condition CPM was associated with less subjective morphine unpleasantness (P=0.001) and greater morphine analgesia (P's<0.05) on both the ischemic pain task (VAS Pain Intensity and Unpleasantness) and heat pain task (VAS Pain Intensity, McGill Pain Questionnaire-Sensory and Present Pain Intensity [PPI] subscales).","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bruehl', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, OH, USA.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Stone', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Rajnish', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Asokumar', 'Initials': 'A', 'LastName': 'Buvanendran', 'Affiliation': 'Department of Anesthesiology, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Chont', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Burns', 'Affiliation': 'Department of Behavioral Science, Rush University, Chicago, IL, USA.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000887']
1327,33086512,Use of Metabolomic Profiling to Understand Variability in Adiposity Changes Following an Intentional Weight Loss Intervention in Older Adults.,"Inter-individual response to dietary interventions remains a major challenge to successful weight loss among older adults. This study applied metabolomics technology to identify small molecule signatures associated with a loss of fat mass and overall weight in a cohort of older adults on a nutritionally complete, high-protein diet. A total of 102 unique metabolites were measured using liquid chromatography-mass spectrometry (LC-MS) for 38 adults aged 65-80 years randomized to dietary intervention and 36 controls. Metabolite values were analyzed in both baseline plasma samples and samples collected following the six-month dietary intervention to consider both metabolites that could predict the response to diet and those that changed in response to diet or weight loss.Eight metabolites changed over the intervention at a nominally significant level: D-pantothenic acid, L-methionine, nicotinate, aniline, melatonin, deoxycarnitine, 6-deoxy-L-galactose, and 10-hydroxydecanoate. Within the intervention group, there was broad variation in the achieved weight-loss and dual-energy x-ray absorptiometry (DXA)-defined changes in total fat and visceral adipose tissue (VAT) mass. Change in the VAT mass was significantly associated with the baseline abundance of α-aminoadipate ( p = 0.0007) and an additional mass spectrometry peak that may represent D-fructose, myo-inositol, mannose, α-D-glucose, allose, D-galactose, D-tagatose, or L-sorbose ( p = 0.0001). This hypothesis-generating study reflects the potential of metabolomic biomarkers for the development of personalized dietary interventions.",2020,"Eight metabolites changed over the intervention at a nominally significant level: D-pantothenic acid, L-methionine, nicotinate, aniline, melatonin, deoxycarnitine, 6-deoxy-L-galactose, and 10-hydroxydecanoate.","['older adults', '38 adults aged 65-80 years randomized to', 'Older Adults']","['liquid chromatography-mass spectrometry (LC-MS', 'Intentional Weight Loss Intervention', 'dietary intervention']","['weight-loss and dual-energy x-ray absorptiometry (DXA)-defined changes in total fat and visceral adipose tissue (VAT) mass', 'Metabolite values']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0008565', 'cui_str': 'Liquid chromatography measurement'}, {'cui': 'C0037813', 'cui_str': 'Mass spectrometry measurement'}, {'cui': 'C1563041', 'cui_str': 'Intentional weight loss'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",38.0,0.03014,"Eight metabolites changed over the intervention at a nominally significant level: D-pantothenic acid, L-methionine, nicotinate, aniline, melatonin, deoxycarnitine, 6-deoxy-L-galactose, and 10-hydroxydecanoate.","[{'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Quillen', 'Affiliation': 'Internal Medicine, Section on Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': ""O'Brien Cox"", 'Affiliation': 'Proteomics and Metabolomics Shared Resource, Comprehensive Cancer Center, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Furdui', 'Affiliation': 'Internal Medicine, Section on Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Jingyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Internal Medicine, Section on Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Internal Medicine, Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Hanzhi', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Internal Medicine, Section on Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Beavers', 'Affiliation': 'Health and Exercise Science, Wake Forest University, Winston-Salem, NC 27109, USA.'}]",Nutrients,['10.3390/nu12103188']
1328,33087156,Getting to implementation: a protocol for a Hybrid III stepped wedge cluster randomized evaluation of using data-driven implementation strategies to improve cirrhosis care for Veterans.,"BACKGROUND
Cirrhosis is a rapidly increasing cause of global mortality. To improve cirrhosis care, the Veterans Health Administration (VHA) developed the Hepatic Innovation Team (HIT) Collaborative to support VA Medical Centers (VAMCs) to deliver evidence-based cirrhosis care. This randomized HIT program evaluation aims to develop and assess a novel approach for choosing and applying implementation strategies to improve the quality of cirrhosis care.
METHODS
Evaluation aims are to (1) empirically determine which combinations of implementation strategies are associated with successful implementation of evidence-based practices (EBPs) for Veterans with cirrhosis, (2) manualize these ""data-driven"" implementation strategies, and (3) assess the effectiveness of data-driven implementation strategies in increasing cirrhosis EBP uptake. Aim 1 will include an online survey of all VAMCs' use of 73 implementations strategies to improve cirrhosis care, as defined by the Expert Recommendations for Implementing Change taxonomy. Traditional statistical as well as configurational comparative methods will both be employed to determine which combinations of implementation strategies are associated with site-level adherence to EBPs for cirrhosis. In aim 2, semi-structured interviews with high-performing VAMCs will be conducted to operationalize successful implementation strategies for cirrhosis care. These data will be used to inform the creation of a step-by-step guide to tailoring and applying the implementation strategies identified in aim 1. In aim 3, this manualized implementation intervention will be assessed using a hybrid type III stepped-wedge cluster randomized design. This evaluation will be conducted in 12 VAMCs, with four VAMCs crossing from control to intervention every 6 months, in order to assess the effectiveness of using data-driven implementation strategies to improve guideline-concordant cirrhosis care.
DISCUSSION
Successful completion of this innovative evaluation will establish the feasibility of using early evaluation data to inform a manualized, user-friendly implementation intervention for VAMCs with opportunities to improve care. This evaluation will provide implementation support tools that can be applied to enhance the implementation of other evidence-based practices.
TRIAL REGISTRATION
This project was registered at ClinicalTrials.Gov ( NCT04178096 ) on 4/29/20.",2020,"Successful completion of this innovative evaluation will establish the feasibility of using early evaluation data to inform a manualized, user-friendly implementation intervention for VAMCs with opportunities to improve care.",['Veterans'],[],[],"[{'cui': 'C0042610', 'cui_str': 'Veterans'}]",[],[],,0.109469,"Successful completion of this innovative evaluation will establish the feasibility of using early evaluation data to inform a manualized, user-friendly implementation intervention for VAMCs with opportunities to improve care.","[{'ForeName': 'Shari S', 'Initials': 'SS', 'LastName': 'Rogal', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Research Office Building (151R), University Drive C, Pittsburgh, PA, 15240, USA. Shari.Rogal@va.gov.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Yakovchenko', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, Edith Nourse Rogers Memorial VA Hospital, Bedford, MA, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Morgan', 'Affiliation': 'Gastroenterology Section, VA Long Beach Healthcare System, Long Beach, CA, USA.'}, {'ForeName': 'Jasmohan S', 'Initials': 'JS', 'LastName': 'Bajaj', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Veterans Affairs, Sierra Pacific Veterans Integrated Service Network, Pharmacy Benefits Management, Mather, CA, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Park', 'Affiliation': 'Office of Healthcare Transformation, Veterans Engineering Resource Center, Washington, DC, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Beste', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, VA Puget Sound Healthcare System, Seattle, WA, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Miech', 'Affiliation': 'Department of Veterans Affairs, Roudebush VA Medical Center, HSR&D Center for Health Information & Communication, VA PRIS-M QUERI, Indianapolis, IN, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Lamorte', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Research Office Building (151R), University Drive C, Pittsburgh, PA, 15240, USA.'}, {'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Neely', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Research Office Building (151R), University Drive C, Pittsburgh, PA, 15240, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Gibson', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Research Office Building (151R), University Drive C, Pittsburgh, PA, 15240, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Malone', 'Affiliation': 'Duke University, Durham, NC, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Chartier', 'Affiliation': 'HIV, Hepatitis and Related Conditions Programs, Office of Specialty Care Services, Veterans Health Administration, Washington, DC, USA.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Taddei', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Garcia-Tsao', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Powell', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Dominitz', 'Affiliation': 'Gastroenterology Section, VA Puget Sound Health Care System, Seattle, WA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ross', 'Affiliation': 'HIV, Hepatitis and Related Conditions Programs, Office of Specialty Care Services, Veterans Health Administration, Washington, DC, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Chinman', 'Affiliation': 'Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Research Office Building (151R), University Drive C, Pittsburgh, PA, 15240, USA.'}]",Implementation science : IS,['10.1186/s13012-020-01050-7']
1329,33106665,Precision medicine treatment in acute myeloid leukemia using prospective genomic profiling: feasibility and preliminary efficacy of the Beat AML Master Trial.,"Acute myeloid leukemia (AML) is the most common diagnosed leukemia. In older adults, AML confers an adverse outcome 1,2 . AML originates from a dominant mutation, then acquires collaborative transformative mutations leading to myeloid transformation and clinical/biological heterogeneity. Currently, AML treatment is initiated rapidly, precluding the ability to consider the mutational profile of a patient's leukemia for treatment decisions. Untreated patients with AML ≥ 60 years were prospectively enrolled on the ongoing Beat AML trial (ClinicalTrials.gov NCT03013998), which aims to provide cytogenetic and mutational data within 7 days (d) from sample receipt and before treatment selection, followed by treatment assignment to a sub-study based on the dominant clone. A total of 487 patients with suspected AML were enrolled; 395 were eligible. Median age was 72 years (range 60-92 years; 38% ≥75 years); 374 patients (94.7%) had genetic and cytogenetic analysis completed within 7 d and were centrally assigned to a Beat AML sub-study; 224 (56.7%) were enrolled on a Beat AML sub-study. The remaining 171 patients elected standard of care (SOC) (103), investigational therapy (28) or palliative care (40); 9 died before treatment assignment. Demographic, laboratory and molecular characteristics were not significantly different between patients on the Beat AML sub-studies and those receiving SOC (induction with cytarabine + daunorubicin (7 + 3 or equivalent) or hypomethylation agent). Thirty-day mortality was less frequent and overall survival was significantly longer for patients enrolled on the Beat AML sub-studies versus those who elected SOC. A precision medicine therapy strategy in AML is feasible within 7 d, allowing patients and physicians to rapidly incorporate genomic data into treatment decisions without increasing early death or adversely impacting overall survival.",2020,Thirty-day mortality was less frequent and overall survival was significantly longer for patients enrolled on the Beat AML sub-studies versus those who elected SOC.,"['acute myeloid leukemia', 'Untreated patients with AML\u2009≥\u200960 years', '487 patients with suspected AML were enrolled; 395 were eligible', 'Acute myeloid leukemia (AML', 'Median age was 72 years (range 60-92 years; 38% ≥75 years); 374 patients (94.7%) had genetic and cytogenetic analysis completed within 7\u2009d and were centrally assigned to a Beat AML sub-study; 224 (56.7%) were enrolled on a Beat AML sub-study', '171 patients elected standard of care (SOC) (103), investigational therapy (28) or palliative care (40); 9 died before treatment assignment']","['cytarabine\u2009+\u2009daunorubicin', 'Precision medicine treatment']","['Demographic, laboratory and molecular characteristics', 'overall survival']","[{'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0752095', 'cui_str': 'Cytogenetic analysis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0949266', 'cui_str': 'Investigational Therapies'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C2718059', 'cui_str': 'P Health'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",487.0,0.168831,Thirty-day mortality was less frequent and overall survival was significantly longer for patients enrolled on the Beat AML sub-studies versus those who elected SOC.,"[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Burd', 'Affiliation': 'The Leukemia & Lymphoma Society, Rye Brook, NY, USA.'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Levine', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Ruppert', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Alice S', 'Initials': 'AS', 'LastName': 'Mims', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Borate', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Eytan M', 'Initials': 'EM', 'LastName': 'Stein', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Prapti', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Baer', 'Affiliation': 'University of Maryland Medical Center, Baltimore, MD, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stock', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Deininger', 'Affiliation': 'The University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Blum', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Schiller', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Olin', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Litzow', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Foran', 'Affiliation': 'Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Tara L', 'Initials': 'TL', 'LastName': 'Lin', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Ball', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boyiadzis', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Traer', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Olatoyosi', 'Initials': 'O', 'LastName': 'Odenike', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Arellano', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Walker', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Vu H', 'Initials': 'VH', 'LastName': 'Duong', 'Affiliation': 'University of Maryland Medical Center, Baltimore, MD, USA.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Kovacsovics', 'Affiliation': 'The University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Collins', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Abigail B', 'Initials': 'AB', 'LastName': 'Shoben', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Nyla A', 'Initials': 'NA', 'LastName': 'Heerema', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Foster', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Jo-Anne', 'Initials': 'JA', 'LastName': 'Vergilio', 'Affiliation': 'Foundation Medicine, Cambridge, MA, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Brennan', 'Affiliation': 'Foundation Medicine, Cambridge, MA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Vietz', 'Affiliation': 'Foundation Medicine, Cambridge, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Severson', 'Affiliation': 'Foundation Medicine, Cambridge, MA, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Rosenberg', 'Affiliation': 'The Leukemia & Lymphoma Society, Rye Brook, NY, USA.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Marcus', 'Affiliation': 'The Leukemia & Lymphoma Society, Rye Brook, NY, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Yocum', 'Affiliation': 'The Leukemia & Lymphoma Society, Rye Brook, NY, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Stefanos', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Druker', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'The Ohio State University, Columbus, OH, USA. John.Byrd@osumc.edu.'}]",Nature medicine,['10.1038/s41591-020-1089-8']
1330,33090368,Neuromagnetic Amygdala Response to Pain-Related Fear as a Brain Signature of Fibromyalgia.,"INTRODUCTION
Fibromyalgia (FM) is a chronic pain condition characterized by impaired emotional regulation. This study explored the brain response to pain-related fear as a potential brain signature of FM.
METHODS
We used a conditioned fear task and magnetoencephalography to record pain-related fear responses in patients with FM. Two blocks of 30 fear responses were collected to compute the response strength in the first block and the strength difference between the first and second blocks (fear habituation). These measurements were investigated for their clinical relevance and compared with measurements obtained from healthy controls and patients with chronic migraine (CM), a different chronic pain condition often comorbid with FM.
RESULTS
Pain-related fear clearly activated the bilateral amygdala and anterior insula in patients with FM (n = 52), patients with CM (n = 50), and the controls (n = 30); the response strength in the first block was consistent across groups. However, fear habituation in the right amygdala decreased in the FM group (vs. CM and control groups, both p ≤ 0.001, no difference between CM and control groups). At the 3-month follow-up, the patients with FM reporting < 30% improvement in pain severity (n = 15) after pregabalin treatment exhibited lower fear habituation in the left amygdala at baseline (vs. ≥ 30% improvement, n = 22, p = 0.019). Receiver operating characteristic analysis confirmed that amygdala fear habituation is a suitable predictor of diagnosis and treatment outcomes of FM (area under the curve > 0.7).
CONCLUSIONS
Amygdala activation to pain-related fear is maladaptive and linked to treatment outcomes in patients with FM. Because the aberrant amygdala response was not observed in the CM group, this response is a potential brain signature of FM.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier, NCT02747940.",2020,"RESULTS
Pain-related fear clearly activated the bilateral amygdala and anterior insula in patients with FM (n = 52), patients with CM (n = 50), and the controls (n = 30); the response strength in the first block was consistent across groups.","['healthy controls and patients with chronic migraine (CM), a different chronic pain condition often comorbid with FM', 'patients with FM']",['conditioned fear task and magnetoencephalography'],"['fear habituation in the right amygdala', 'response strength', 'fear habituation', 'aberrant amygdala response', 'pain severity']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0711474,"RESULTS
Pain-related fear clearly activated the bilateral amygdala and anterior insula in patients with FM (n = 52), patients with CM (n = 50), and the controls (n = 30); the response strength in the first block was consistent across groups.","[{'ForeName': 'Fu-Jung', 'Initials': 'FJ', 'LastName': 'Hsiao', 'Affiliation': 'Brain Research Center, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Ta', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'Brain Research Center, National Yang-Ming University, Taipei, Taiwan. wtchen@vghtpe.gov.tw.'}, {'ForeName': 'Yu-Chieh', 'Initials': 'YC', 'LastName': 'Ko', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hung-Yu', 'Initials': 'HY', 'LastName': 'Liu', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yen-Feng', 'Initials': 'YF', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Pin', 'Initials': 'SP', 'LastName': 'Chen', 'Affiliation': 'Brain Research Center, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Kuan-Lin', 'Initials': 'KL', 'LastName': 'Lai', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Yi', 'Initials': 'HY', 'LastName': 'Lin', 'Affiliation': 'Department of Allergy, Immunology and Rheumatology, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Coppola', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome Polo Pontino, Latina, Italy.'}, {'ForeName': 'Shuu-Jiun', 'Initials': 'SJ', 'LastName': 'Wang', 'Affiliation': 'Brain Research Center, National Yang-Ming University, Taipei, Taiwan. sjwang@vghtpe.gov.tw.'}]",Pain and therapy,['10.1007/s40122-020-00206-z']
1331,33086137,Effect of resin coating on highly viscous glass ionomer cements: A dynamic analysis.,"OBJECTIVES
This study determined the effects of self-adhesive resin coatings on viscoelastic properties of highly viscous glass ionomer cements (HVGICs) using dynamic mechanical analysis.
MATERIALS AND METHODS
The HVGICs evaluated were Zirconomer [ZR] (Shofu), Equia Forte [EQ] (GC) and Riva [RV] (SDI). Sixty specimens (12mm x 2mm x 2mm) of each material were fabricated using customized Teflon molds. After initial set, the specimens were removed from their molds, finished, measured and randomly divided into 3 groups of 20. Half the specimens in each group were left uncoated while the remaining half was covered with the respective manufacturers' resin coating. The specimens were subsequently conditioned in distilled water, artificial saliva or citric acid at 37°C for 7 days. The uncoated and coated specimens (n=10) were then subjected to dynamic mechanical testing in flexure mode at 37°C with a frequency of 0.1 to 10Hz. Storage modulus, loss modulus and loss tangent data were subjected to normality testing and statistical analysis using one-way ANOVA/Scheffe's post-hoc test and Ttest at significance level p<0.05.
RESULTS
Mean storage modulus ranged from 1.39 ± 0.36 to 10.80 ± 0.86 GPa while mean loss modulus varied from 0.13 ± 0.03 to 0.70 ± 0.14 GPa after conditioning in the different mediums. Values for loss tangent ranged from 39.4 ± 7.75 to 213.2 ± 20.11 (x10 -3 ). Significant differences in visco-elastic properties were observed between mediums and materials. When conditioned in distilled water and artificial saliva,storage modulus was significantly improved when ZR, EQ and RV were uncoated. Significantly higher values were, however, observed with resin coating when the materials were exposed to citric acid.
CONCLUSION
The visco-elastic properties of HVGICs were influenced by both resin coating and chemical environment.",2020,"When conditioned in distilled water and artificial saliva,storage modulus was significantly improved when ZR, EQ and RV were uncoated.",['highly viscous glass ionomer cements'],"['resin coating', 'self-adhesive resin coatings', 'distilled water, artificial saliva or citric acid']","['ZR, EQ and RV', 'Storage modulus, loss modulus and loss tangent data', 'visco-elastic properties', 'Zirconomer [ZR] (Shofu), Equia Forte [EQ] (GC) and Riva [RV] (SDI']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}]","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036088', 'cui_str': 'Artificial saliva'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}]","[{'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",,0.033953,"When conditioned in distilled water and artificial saliva,storage modulus was significantly improved when ZR, EQ and RV were uncoated.","[{'ForeName': 'A U', 'Initials': 'AU', 'LastName': 'Yap', 'Affiliation': 'Department of Dentistry, Ng Teng Fong General Hospital, National University Health System, Singapore; Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya, Malaysia; Faculty of Dentistry, National University of Singapore, Singapore; Duke-NUS Medical School, Singapore; National Dental Research Institute Singapore, National Dental Centre Singapore, Singapore.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Ong', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya, Malaysia.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Yahya', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya, Malaysia. Electronic address: nazlin@um.edu.my.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.104120']
1332,33086144,Behavioral activation with mindfulness in treating subthreshold depression in primary care: A cost-utility and cost-effectiveness analysis alongside a randomized controlled trial.,"This study aimed to assess the cost-utility and cost-effectiveness of group-based behavioral activation with mindfulness (BAM) versus care as usual (CAU) for treating subthreshold depression in primary care. Adults aged 18 years or older with subthreshold depression were randomized into two arms and were followed up for 12 months. BAM group was provided with eight 2-h weekly treatment by trained allied healthcare workers. CAU group could access to usual medical care but did not receive extra interventions. The health service cost in the past 12 months was self-reported by the participants. Quality-adjusted Life Years (QALYs) and clinical outcome (incidence of major depressive disorder progression) were measured. Willingness-to-pay ratio for cost-utility analysis (CUA) and cost-effectiveness analysis (CEA) was US$50,000 per QALY and US$20,000 per prevented major depression case, respectively. These ratios were used in the cost-effective acceptability curve analyses to estimate the probability of cost-effectiveness of the estimated incremental cost effectiveness ratios (ICER) of BAM versus CAU. A total of 115 and 116 participants were included in the BAM group and CAU respectively. The estimated CUA ICER was US5,979 per QALY and had a probability of 0.93 that BAM was cost-effective when compared to CAU. Furthermore, when compared to CAU, BAM was cost-effective in preventing progression of major depression: the estimated CEA ICER was US$1046 per preventable case of major progression with a probability of 0.99 to be cost-effective. Group-based BAM is considered as a cost-effective alternative treatment for treating subthreshold depression by preventing major depressive disorder.",2020,"The estimated CUA ICER was US5,979 per QALY and had a probability of 0.93 that BAM was cost-effective when compared to CAU.","['A total of 115 and 116 participants were included in the BAM group and CAU respectively', 'primary care', 'Adults aged 18 years or older with subthreshold depression']","['group-based behavioral activation with mindfulness (BAM) versus care as usual (CAU', 'CAU', 'BAM']","['estimated CUA ICER', 'health service cost', 'Quality-adjusted Life Years (QALYs) and clinical outcome (incidence of major depressive disorder progression', 'Willingness-to-pay ratio for cost-utility analysis (CUA) and cost-effectiveness analysis (CEA', 'cost-utility and cost-effectiveness']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C3853052', 'cui_str': 'Cost-Utility Analysis'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}]",,0.0462248,"The estimated CUA ICER was US5,979 per QALY and had a probability of 0.93 that BAM was cost-effective when compared to CAU.","[{'ForeName': 'Yuying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong SAR, China; School of Public Health, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Samuel Y S', 'Initials': 'SYS', 'LastName': 'Wong', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Dexing', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Cynthia H J', 'Initials': 'CHJ', 'LastName': 'Chen', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Benjamin H K', 'Initials': 'BHK', 'LastName': 'Yip', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong SAR, China. Electronic address: benyip@cuhk.edu.hk.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.006']
1333,33086145,Bifrontal high-frequency transcranial random noise stimulation is not effective as an add-on treatment in depression.,"BACKGROUND
Depressive disorders are linked to dysfunction in prefrontal cortical areas. Hence, non-invasive neurostimulation of the prefrontal cortex has demonstrated antidepressant efficacy. In the present study, we investigated the efficacy of high frequency transcranial random noise stimulation (hf-tRNS) as an add-on treatment for depression in a sham-controlled randomized trial.
METHODS
Forty in-patients with depression were randomized and treated with real or sham hf-tRNS (100-650 Hz) with 0 mA offset. The electrodes were mounted over the left and right dorsolateral prefrontal cortex. The Hamilton Depression Rating Scale (primary outcome), the Major Depression Inventory, the Clinical Global Impression scale and the Global Assessment of Functioning scale were used for assessment at baseline, after 3 weeks of intervention (end of treatment), and 9 weeks after intervention. Safety parameters included cognitive functioning and reported side-effects.
RESULTS
Comparison of real and sham treatment at the planned interim analysis showed an amelioration of symptoms in both groups for all outcomes with numeric but not statistically significant superiority of the sham arm for the primary outcome. Thus, the study was terminated prematurely after an interim analysis. There were no systematic differences with respect to safety parameters.
LIMITATIONS
The negative finding might be related to the specific stimulation parameters used in this study.
CONCLUSIONS
Our study suggests that prefrontal hf-tRNS is safe but not effective as an add-on treatment of depression. The challenge for future studies employing transcranial electric stimulation remains to identify effective stimulation parameters for the treatment of depression.",2020,"The Hamilton Depression Rating Scale (primary outcome), the Major Depression Inventory, the Clinical Global Impression scale and the Global Assessment of Functioning scale were used for assessment at baseline, after 3 weeks of intervention (end of treatment), and 9 weeks after intervention.",['Forty in-patients with depression'],"['transcranial electric stimulation', 'real or sham hf-tRNS', 'high frequency transcranial random noise stimulation (hf-tRNS']","['Hamilton Depression Rating Scale (primary outcome), the Major Depression Inventory, the Clinical Global Impression scale and the Global Assessment of Functioning scale', 'cognitive functioning and reported side-effects', 'amelioration of symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0424188,"The Hamilton Depression Rating Scale (primary outcome), the Major Depression Inventory, the Clinical Global Impression scale and the Global Assessment of Functioning scale were used for assessment at baseline, after 3 weeks of intervention (end of treatment), and 9 weeks after intervention.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schecklmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany. Electronic address: martin.schecklmann@medbo.de.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Nejati', 'Affiliation': 'Department of Psychology, Shahid Beheshti University, Iran.'}, {'ForeName': 'Timm B', 'Initials': 'TB', 'LastName': 'Poeppl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, RWTH Aachen University, Germany.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Peytard', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Rupprecht', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Wetter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Langguth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Kreuzer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.011']
1334,33086156,Model and approach for assessing implementation context and fidelity in the HEALing Communities Study.,"BACKGROUND
In response to the U.S. opioid epidemic, the HEALing (Helping to End Addiction Long-term SM ) Communities Study (HCS) is a multisite, wait-listed, community-level cluster-randomized trial that aims to test the novel Communities That HEAL (CTH) intervention, in 67 communities. CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths. We present the rationale for and adaptation of the RE-AIM/PRISM framework and methodological approach used to capture the CTH implementation context and to evaluate implementation fidelity.
METHODS
HCS measures key domains of the internal and external CTH implementation context with repeated annual surveys and qualitative interviews with community coalition members and key stakeholders. Core constructs of fidelity include dosage, adherence, quality, and program differentiation-the adaptation of the CTH intervention to fit each community's needs. Fidelity measures include a monthly CTH checklist, collation of artifacts produced during CTH activities, coalition and workgroup attendance, and coalition meeting minutes. Training and technical assistance delivered by the research sites to the communities are tracked monthly.
DISCUSSION
To help attenuate the nation's opioid epidemic, the adoption of EBPs must be increased in communities. The HCS represents one of the largest and most complex implementation research experiments yet conducted. Our systematic examination of implementation context and fidelity will significantly advance understanding of how to best evaluate community-level implementation of EBPs and assess relations among implementation context, fidelity, and intervention impact.",2020,"CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths.",[],"['CTH intervention', 'HEAL (CTH) intervention', 'CTH']","['monthly CTH checklist, collation of artifacts produced during CTH activities, coalition and workgroup attendance, and coalition meeting minutes']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.0247065,"CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths.","[{'ForeName': 'Hannah K', 'Initials': 'HK', 'LastName': 'Knudsen', 'Affiliation': 'Department of Behavioral Science and Center on Drug and Alcohol Research, University of Kentucky, 845 Angliana Avenue, Room 204, Lexington, KY, 40508, USA. Electronic address: hannah.knudsen@uky.edu.'}, {'ForeName': 'Mari-Lynn', 'Initials': 'ML', 'LastName': 'Drainoni', 'Affiliation': 'Section of Infectious Diseases and Evans Center for Implementation and Improvement Sciences, Department of Medicine, Boston University School of Medicine, Department of Health Law, Policy and Management, Boston University School of Public Health, 801 Massachusetts Avenue, Room 2014, Boston, MA, 02118, USA. Electronic address: drainoni@bu.edu.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Gilbert', 'Affiliation': 'Social Intervention Group, Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA. Electronic address: lg123@columbia.edu.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Huerta', 'Affiliation': 'College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 530, Columbus, OH, 43210, USA. Electronic address: timothy.huerta@osumc.edu.'}, {'ForeName': 'Carrie B', 'Initials': 'CB', 'LastName': 'Oser', 'Affiliation': 'Department of Sociology and Center on Drug and Alcohol Research, University of Kentucky, 1531 Patterson Office Tower, Lexington, KY, 40506, USA. Electronic address: carrie.oser@uky.edu.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Aldrich', 'Affiliation': 'CATALYST, the Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research, College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 530, Columbus, OH, 43210, USA. Electronic address: alison.aldrich@osumc.edu.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Drive, Box 120, New York, NY, 10032, USA. Electronic address: anc2002@cumc.columbia.edu.'}, {'ForeName': 'Erika L', 'Initials': 'EL', 'LastName': 'Crable', 'Affiliation': 'Evans Center for Implementation and Improvement Sciences, Department of Medicine, Boston University School of Medicine, Department of Health Law, Policy and Management, Boston University School of Public Health, 801 Massachusetts Avenue, Room 2030, Boston, MA, 02118, USA. Electronic address: ecrable@bu.edu.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Garner', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. Electronic address: bgarner@rti.org.'}, {'ForeName': 'LaShawn M', 'Initials': 'LM', 'LastName': 'Glasgow', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. Electronic address: lglasgow@rti.org.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Goddard-Eckrich', 'Affiliation': 'Social Intervention Group, Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA. Electronic address: dg2121@columbia.edu.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Marks', 'Affiliation': 'Department of Behavioral Science, University of Kentucky, 1100 Veterans Drive, Medical Behavioral Science Building Room 108, Lexington, KY, 40536, USA. Electronic address: katie.marks@uky.edu.'}, {'ForeName': 'Ann Scheck', 'Initials': 'AS', 'LastName': 'McAlearney', 'Affiliation': 'Department of Family and Community Medicine and CATALYST, the Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research, College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 530, Columbus, OH, 43210, USA. Electronic address: ann.mcalearney@osumc.edu.'}, {'ForeName': 'Emmanuel A', 'Initials': 'EA', 'LastName': 'Oga', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. Electronic address: eoga@rti.org.'}, {'ForeName': 'Ariel L', 'Initials': 'AL', 'LastName': 'Scalise', 'Affiliation': 'Department of Infectious Disease, Boston Medical Center, 801 Massachusetts Avenue, Boston, MA, 02118, USA. Electronic address: ariel.scalise@bmc.org.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Walker', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 520, Columbus, OH, 43210, USA. Electronic address: daniel.walker@osumc.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108330']
1335,33086159,Using artificial intelligence tools in answering important clinical questions: The KEYNOTE-183 multiple myeloma experience.,"The phase III, randomized, active-controlled, multicenter, open-label KEYNOTE-183 study (NCT02576977) evaluating pomalidomide and low dose dexamethasone (standard-of-care [SOC]) with or without pembrolizumab in patients with refractory or relapsed and refractory multiple myeloma (rrMM) was placed on full clinical hold by the US FDA on July 03, 2017 due to an imbalance in the number of deaths between arms. Clinically-led subgroup analyses are typically used to shed light on clinical findings. However, this approach is not always successful. We propose a systematic approach using the artificial intelligence tools to identifying risk factors and subgroups contributing to the overall death (prognostic) or to the excess death observed in the pembrolizumab plus SOC arm (predictive) of the KEYNOTE-183 study. In KEYNOTE-183, with a data cutoff date of June 02, 2017, we identified plasmacytoma as a prognostic factor, and ECOG performance status as a predictive factor of death. In addition, a qualitative interaction was observed between ECOG performance status and the treatment arm. The subsequent subgroup analysis based on ECOG performance status confirmed that more deaths were associated with pembrolizumab plus SOC versus SOC alone in patients with ECOG performance status 1.",2020,The subsequent subgroup analysis based on ECOG performance status confirmed that more deaths were associated with pembrolizumab plus SOC versus SOC alone in patients with ECOG performance status 1.,['patients with refractory or relapsed and refractory multiple myeloma (rrMM'],['dexamethasone (standard-of-care [SOC]) with or without pembrolizumab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]",[],,0.0440892,The subsequent subgroup analysis based on ECOG performance status confirmed that more deaths were associated with pembrolizumab plus SOC versus SOC alone in patients with ECOG performance status 1.,"[{'ForeName': 'Jason J Z', 'Initials': 'JJZ', 'LastName': 'Liao', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA. Electronic address: a4statistics@gmail.com.'}, {'ForeName': 'Mohammed Z H', 'Initials': 'MZH', 'LastName': 'Farooqui', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marinello', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hartzel', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Keaven', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Junshui', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Gause', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106179']
1336,33087406,A Cognitive Aid for Neonatal Epinephrine Dosing.,"OBJECTIVES
Errors are common when preparing epinephrine for neonatal resuscitation. Epinephrine is available in two concentrations (1 mg/mL and 1 mg/10 mL) and requires weight-based calculations, which increases the risk of dosing errors. We developed a printed cognitive aid to assist with dose preparation. We hypothesized that the cognitive aid would result in a 25% difference in errors in preparing the dose of epinephrine during simulated neonatal resuscitation.
METHODS
Nurses ( N = 100) in a large academic and community hospital were randomly assigned to calculate the intended dose and prepare epinephrine for neonatal resuscitation with or without the cognitive aid. Scenarios were video recorded and timed. Secondary outcomes included errors in the written intended dose, errors in choosing the correct epinephrine concentration, and time required to prepare the final dose. Proportions were compared by using Fisher's exact test. Variables influencing dosing errors were investigated by using logistic regression.
RESULTS
Using the cognitive aid significantly decreased the proportion of doses prepared incorrectly (24% vs 50%; P = .01). The aid also decreased errors in choosing the correct epinephrine concentration (12% vs 44%; P < .001), but there was no difference in the written intended dose or the time to prepare the dose. Years of experience, self-perceived math comfort, and anxiety were not predictive of dosing errors.
CONCLUSIONS
A simple cognitive aid decreased epinephrine dosing errors during simulated neonatal resuscitation but did not improve efficiency. Despite the effectiveness of the cognitive aid, errors were not completely eliminated. This is a serious safety risk for newborns and requires additional interventions.",2020,Using the cognitive aid significantly decreased the proportion of doses prepared incorrectly (24% vs 50%; P = .01).,['Nurses ( N = 100) in a large academic and community hospital'],"['epinephrine', 'Epinephrine', 'epinephrine for neonatal resuscitation with or without the cognitive aid']","['Years of experience, self-perceived math comfort, and anxiety', 'errors in the written intended dose, errors in choosing the correct epinephrine concentration, and time required to prepare the final dose', 'correct epinephrine concentration']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}]",,0.0443206,Using the cognitive aid significantly decreased the proportion of doses prepared incorrectly (24% vs 50%; P = .01).,"[{'ForeName': 'Kate D', 'Initials': 'KD', 'LastName': 'Brune', 'Affiliation': 'Department of Pediatrics, St Joseph Mercy Hospital, Ann Arbor, Michigan.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Bhatt-Mehta', 'Affiliation': 'Department of Clinical Pharmacy, College of Pharmacy and.'}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Rooney', 'Affiliation': 'Department of Learning Health Sciences, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Adams', 'Affiliation': ""Department of Pediatrics, Ascension St John Children's Hospital, Detroit, Michigan; and.""}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Weiner', 'Affiliation': ""Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Michigan Medicine, University of Michigan and C.S. Mott Children's Hospital, Ann Arbor, Michigan gweiner@med.umich.edu.""}]",Hospital pediatrics,['10.1542/hpeds.2020-000299']
1337,33089408,Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal ® ) in glioma patients in China.,"BACKGROUND
Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20-100 mg) of generic temozolomide in the form of TOZ039 and Temodal ® capsules administered to brain tumor patients.
STUDY DESIGN
An open-label, randomized, two-phase, two-period, crossover pharmacokinetic study was performed in a single institution. The reference and test drugs were prescribed at a dose of 150 mg/m 2 daily from days 1 to 5 of a 28-day cycle in the first phase; in the second phase, either a 150- or 200-mg/m 2 dose was prescribed, depending on patient tolerance. On days 1 and 2 of each phase, a fixed 200-mg dose was administered either as ten 20-mg capsules in the first cycle or two 100-mg capsules in the second cycle. Drug administration in the first two days was randomized, i.e., if TOZ309 was administered on day 1, Temodal ® was administered on day 2, and vice versa. The rest of the prescribed dose was administered in the form of Temodal ® and spread equally over days 3-5. Blood samples were obtained for pharmacokinetic evaluation on days 1 and 2. Bioequivalence was demonstrated if the geometric means ratio of the three main pharmacokinetic parameters (mean maximum plasma concentration (C max ), area under the concentration-time curve (AUC) 0-t, AUC 0-∞ ) fell within the equivalence boundary of 80-125%.
RESULTS
Twenty-nine glioblastoma multiforme or anaplastic astrocytoma patients were enrolled and dosed with the test and reference formulations under fasting conditions. The 90% confidence interval of the geometric means ratio for C max (91.08%, 106.18%), AUC 0-t (98.62%,102.18%), and AUC 0-∞ (98.65%, 102.21%) was well within the 80%-125% range for the 20-mg capsule, as was the C max (90.49%, 113.32%), AUC 0-t (99.89%, 104.63%) and AUC 0-∞ (99.99%, 104.67%) for the 100-mg capsule drug product. Additionally, all the secondary pharmacokinetic parameters were not significantly different. After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression. Adverse events were reported in 82.8% (24/29) patients, and treatment emergent adverse events were reported in 72.4% (21/29) patients.
CONCLUSION
It can be concluded that 20-mg and 100-mg capsules of TOZ309 are bioequivalent to Temodal ® capsules of the same strength under fasting conditions.
TRIAL REGISTRATION
https://www.chinadrugtrials.org.cn/index.html , CTR2017 0122.",2020,"After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression.","['Twenty-nine glioblastoma multiforme or anaplastic astrocytoma patients', 'glioma patients in China', 'patients with primary brain tumors']","['Temozolomide', 'generic temozolomide', 'TOZ309', '20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal ® ']","['Adverse events', 'adverse events', 'no mortality', 'severe adverse events', 'adverse effect (life-threatening seizures', 'geometric means ratio of the three main pharmacokinetic parameters (mean maximum plasma concentration (C max ), area under the concentration-time curve (AUC) 0-t, AUC 0-∞ ) fell', 'AUC 0-t', 'geometric means ratio for C max']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0334579', 'cui_str': 'Astrocytoma, anaplastic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0750974', 'cui_str': 'Primary Brain Neoplasms'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1248697', 'cui_str': 'temozolomide Oral Capsule'}, {'cui': 'C4082706', 'cui_str': 'Temodal'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.0671231,"After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression.","[{'ForeName': 'Chaoying', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Pharmacy Phase I Clinical Trial Center, National Clinical Research Center for Geriatric Diseases, Xuanwu Hospital of Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Qingtang', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Neurosurgery, National Clinical Research Center for Geriatric Diseases, Xuanwu Hospital of Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Geriatrics, National Clinical Research Center for Geriatric Diseases, Xuanwu Hospital of Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'TOT Biopharm Ltd, Suzhou, 215024, China.'}, {'ForeName': 'Xiaobao', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'TOT Biopharm Ltd, Suzhou, 215024, China.'}, {'ForeName': 'Xinxia', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'TOT Biopharm Ltd, Suzhou, 215024, China.'}, {'ForeName': 'Guoguang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurosurgery, National Clinical Research Center for Geriatric Diseases, Xuanwu Hospital of Capital Medical University, Beijing, 100053, China. ggzhao@xwhosp.org.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy Phase I Clinical Trial Center, National Clinical Research Center for Geriatric Diseases, Xuanwu Hospital of Capital Medical University, Beijing, 100053, China. zhanglan@xwhosp.org.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04175-0']
1338,33091585,Identification of undiagnosed atrial fibrillation patients using a machine learning risk prediction algorithm and diagnostic testing (PULsE-AI): Study protocol for a randomised controlled trial.,"Atrial fibrillation (AF) is associated with an increased risk of stroke, enhanced stroke severity, and other comorbidities. However, AF is often asymptomatic, and frequently remains undiagnosed until complications occur. Current screening approaches for AF lack either cost-effectiveness or diagnostic sensitivity; thus, there is interest in tools that could be used for population screening. An AF risk prediction algorithm, developed using machine learning from a UK dataset of 2,994,837 patients, was found to be more effective than existing models at identifying patients at risk of AF. Therefore, the aim of the trial is to assess the effectiveness of this risk prediction algorithm combined with diagnostic testing for the identification of AF in a real-world primary care setting. Eligible participants (aged ≥30 years and without an existing AF diagnosis) registered at participating UK general practices will be randomised into intervention and control arms. Intervention arm participants identified at highest risk of developing AF (algorithm risk score ≥ 7.4%) will be invited for a 12‑lead electrocardiogram (ECG) followed by two-weeks of home-based ECG monitoring with a KardiaMobile device. Control arm participants will be used for comparison and will be managed routinely. The primary outcome is the number of AF diagnoses in the intervention arm compared with the control arm during the research window. If the trial is successful, there is potential for the risk prediction algorithm to be implemented throughout primary care for narrowing the population considered at highest risk for AF who could benefit from more intensive screening for AF. Trial Registration: NCT04045639.",2020,"An AF risk prediction algorithm, developed using machine learning from a UK dataset of 2,994,837 patients, was found to be more effective than existing models at identifying patients at risk of AF.","['Eligible participants (aged ≥30\u202fyears and without an existing AF diagnosis) registered at participating UK general practices', 'undiagnosed atrial fibrillation patients']","['12‑lead electrocardiogram (ECG) followed by two-weeks of home-based ECG monitoring with a KardiaMobile device', 'machine learning risk prediction algorithm and diagnostic testing (PULsE-AI']",['number of AF diagnoses'],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.124353,"An AF risk prediction algorithm, developed using machine learning from a UK dataset of 2,994,837 patients, was found to be more effective than existing models at identifying patients at risk of AF.","[{'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Hill', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Nathan.Hill@bms.com.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Arden', 'Affiliation': 'Park Surgery, Chandlers Ford, Hampshire, UK. Electronic address: chrisarden@nhs.net.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Beresford-Hulme', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: l.m.beresford91@googlemail.com.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Camm', 'Affiliation': ""Cardiology Clinical Academic Group, Molecular & Clinical Sciences Research Institute, St. George's University of London, London, UK. Electronic address: jcamm@sgul.ac.uk.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clifton', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, UK. Electronic address: davidc@robots.ox.ac.uk.'}, {'ForeName': 'D Wyn', 'Initials': 'DW', 'LastName': 'Davies', 'Affiliation': ""St Mary's Hospital, London, UK.""}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Farooqui', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Usman.Farooqui@bms.com.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gordon', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: jason.gordon@heor.co.uk.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Groves', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: lara.groves@heor.co.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hurst', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: michael.hurst@heor.co.uk.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lawton', 'Affiliation': 'School of Medicine, Keele University, Staffordshire, UK. Electronic address: s.a.lawton@keele.ac.uk.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lister', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Steven.Lister@bms.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mallen', 'Affiliation': 'School of Medicine, Keele University, Staffordshire, UK. Electronic address: c.d.mallen@keele.ac.uk.'}, {'ForeName': 'Anne-Celine', 'Initials': 'AC', 'LastName': 'Martin', 'Affiliation': 'Université de Paris, Innovative Therapies in Haemostasis, INSERM, Hôpital Européen Georges Pompidou, Service de Cardiologie, 20 rue Leblanc, Paris, France.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'McEwan', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: phil.mcewan@heor.co.uk.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Pollock', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Kevin.Pollock@bms.com.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rogers', 'Affiliation': 'PHASTAR, London, UK. Electronic address: jennifer.rogers@phastar.com.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Sandler', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Belinda.Sandler@bms.com.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Sugrue', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: daniel.sugrue@heor.co.uk.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Cohen', 'Affiliation': ""Department of Haematological Medicine, Guys and St Thomas' NHS Foundation Trust, King's College London, London, UK. Electronic address: alexander.cohen@kcl.ac.uk.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106191']
1339,33091807,Modality effects in verbal working memory updating: Transcranial direct current stimulation over human inferior frontal gyrus and posterior parietal cortex.,"Verbal working memory (VWM) involves visual and auditory verbal information. Neuroimaging studies have shown significant modality effects for VWM in the left posterior parietal cortex (PPC). The left inferior frontal gyrus (IFG) is more sensitive to auditory and phonological information. However, much less is known about the effects of transcranial direct current stimulation (tDCS) over the left PPC and IFG on different sensory modalities of VWM (auditory vs. visual). Therefore, the present study aimed to examine whether tDCS over the left PPC and IFG affects visual and auditory VWM updating performance using a single-blind design. Fifty-one healthy participants were randomly assigned to three tDCS groups (left PPC/left IFG/sham) and were asked to complete both the visual and auditory letter 3-back tasks. Results showed that stimulating the left PPC enhanced the response efficiency of visual, but not auditory, VWM compared with the sham condition. Anodal stimulation to the left IFG improved the response efficiency of both tasks. The present study revealed a modality effect of VWM in the left PPC, while the left IFG had a causal role in VWM updating of different sensory modalities.",2020,"Results showed that stimulating the left PPC enhanced the response efficiency of visual, but not auditory, VWM compared with the sham condition.",['Fifty-one healthy participants'],"['tDCS', 'tDCS groups (left PPC/left IFG/sham) and were asked to complete both the visual and auditory letter 3-back tasks', 'transcranial direct current stimulation (tDCS']","['response efficiency of visual', 'Verbal working memory (VWM) involves visual and auditory verbal information']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456856', 'cui_str': 'Left posterior'}, {'cui': 'C0030560', 'cui_str': 'Parietal lobe structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0152298', 'cui_str': 'Structure of inferior frontal gyrus'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]",51.0,0.031288,"Results showed that stimulating the left PPC enhanced the response efficiency of visual, but not auditory, VWM compared with the sham condition.","[{'ForeName': 'Rongjuan', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China.""}, {'ForeName': 'Yangmei', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China.""}, {'ForeName': 'Ziyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China.""}, {'ForeName': 'Xuqun', 'Initials': 'X', 'LastName': 'You', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China. Electronic address: youxuqun@snnu.edu.cn.""}]",Brain and cognition,['10.1016/j.bandc.2020.105630']
1340,33091844,Operationalizing and selecting outcome measures for the HEALing Communities Study.,"BACKGROUND
The Helping to End Addiction Long-term SM (HEALing) Communities Study (HCS) is a multisite, parallel-group, cluster randomized wait-list controlled trial evaluating the impact of the Communities That HEAL intervention to reduce opioid overdose deaths and associated adverse outcomes. This paper presents the approach used to define and align administrative data across the four research sites to measure key study outcomes.
METHODS
Priority was given to using administrative data and established data collection infrastructure to ensure reliable, timely, and sustainable measures and to harmonize study outcomes across the HCS sites.
RESULTS
The research teams established multiple data use agreements and developed technical specifications for more than 80 study measures. The primary outcome, number of opioid overdose deaths, will be measured from death certificate data. Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths: (1) number of naloxone units distributed in HCS communities; (2) number of unique HCS residents receiving Food and Drug Administration-approved buprenorphine products for treatment of opioid use disorder; and (3) number of HCS residents with new incidents of high-risk opioid prescribing.
CONCLUSIONS
The HCS has already made an impact on existing data capacity in the four states. In addition to providing data needed to measure study outcomes, the HCS will provide methodology and tools to facilitate data-driven responses to the opioid epidemic, and establish a central repository for community-level longitudinal data to help researchers and public health practitioners study and understand different aspects of the Communities That HEAL framework.",2020,Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths:,[],"['buprenorphine', 'HEAL intervention']","['support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths', 'number of opioid overdose deaths, will be measured from death certificate data']",[],"[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C0011066', 'cui_str': 'Death certificate'}]",,0.102551,Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths:,"[{'ForeName': 'Svetla', 'Initials': 'S', 'LastName': 'Slavova', 'Affiliation': 'Department of Biostatistics, University of Kentucky, Healthy Kentucky Research Building RB2, Suite 260, 760 Press Avenue, Lexington, KY, 40536, USA. Electronic address: ssslav2@email.uky.edu.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'LaRochelle', 'Affiliation': 'Clinical Addiction Research and Education Unit, Section of General Internal Medicine, Department of Medicine, Boston University School of Medicine and Boston Medical Center, 801 Massachusetts Avenue, 2nd Floor, Boston, MA, 02218, USA. Electronic address: marc.larochelle@bmc.org.'}, {'ForeName': 'Elisabeth D', 'Initials': 'ED', 'LastName': 'Root', 'Affiliation': 'Department of Geography and Division of Epidemiology, The Ohio State University, and Translational Data Analytics Institute Columbus, The Ohio State University, 1036 Derby Hall, 154 N. Oval Mall, Columbus, OH, 43210, USA. Electronic address: root.145@osu.edu.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Room 1059, Miami, FL, 33136, USA. Electronic address: dfeaster@med.miami.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Villani', 'Affiliation': 'National Institutes of Health, National Institute on Drug Abuse, 3WFN, MSC 6025, 301 North Stonestreet Avenue, Bethesda, MD, 20892, USA. Electronic address: jennifer.villani@nih.gov.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Knott', 'Affiliation': 'Social, Statistical and Environment Sciences Survey Research Division, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA. Electronic address: cknott@rti.org.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Talbert', 'Affiliation': 'Division of Biomedical Informatics, University of Kentucky College of Medicine, 267 Healthy Kentucky Research Building, 760 Press Avenue, Lexington, KY, 40536, USA. Electronic address: jeff.talbert@uky.edu.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mack', 'Affiliation': 'Ohio Colleges of Medicine Government Resource Center, The Ohio State University Wexner Medical Center, 150 Pressey Hall, 1070 Carmack Road, Columbus, OH, 43210, USA. Electronic address: Aimee.mack@osumc.edu.'}, {'ForeName': 'Dushka', 'Initials': 'D', 'LastName': 'Crane', 'Affiliation': 'Ohio Colleges of Medicine Government Resource Center, The Ohio State University Wexner Medical Center, 150 Pressey Hall, 1070 Carmack Road, Columbus, OH, 43210, USA. Electronic address: Dushka.crane@osumc.edu.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Bernson', 'Affiliation': 'Massachusetts Department of Public Health, 250 Washington Street, Boston, MA, 02108, USA. Electronic address: Dana.Bernson@mass.gov.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Booth', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, 6110 Executive Blvd, Suite 900, Rockville, MD, 20852, USA. Electronic address: abooth@rti.org.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Walsh', 'Affiliation': 'Department of Behavioral Science and Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Avenue, Lexington, KY, 40508, USA. Electronic address: sharon.walsh@uky.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108328']
1341,33091856,"Efficacy of cinnamon patch treatment for alleviating symptoms of overactive bladder: A double-blind, randomized, placebo-controlled trial.","BACKGROUND
Current treatments for overactive bladder (OAB) have limited efficacy, low persistence and a high rate of adverse events commonly leading to treatment cessation in clinical practice. Clinicians in Asia commonly use traditional Chinese medicine as an alternative for OAB treatment despite it having uncertain efficacy and safety. To evaluate the efficacy and safety of cinnamon patch (CP) treatment for alleviating symptoms of OAB, a double-blind randomized, placebo-controlled trial was conducted in the present study.
MATERIALS AND METHODS
In this 6-week randomized clinical trial conducted in an outpatient setting, 66 subjects diagnosed as having OAB were enrolled and treated with a placebo (n=33) or CP (n=33). The OAB symptom score (OABSS) was selected as the primary end point, and a patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume were selected as secondary end points. Statistical analyses were performed with IBM SPSS Statistics 20. Groups were compared using an independent sample t-test, Fisher exact test, and Chi-squared test.
RESULTS
In total, 66 participants (40 women and 26 men), 60.35 ± 12.77 years of age, were included in the intention-to-treat analyses. Baseline characteristics were comparable between the CP (n ==33) and placebo (n ==33) groups. Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60).
CONCLUSIONS
Compared to a placebo, treatment with CP might be considered an effective and safe complementary therapy for OAB. Further studies employing a positive control, different dosage forms, larger sample sizes, and longer treatment periods are warranted.",2020,"Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60).
","['66 subjects diagnosed as having OAB were enrolled and treated with a', 'overactive bladder (OAB', 'n=33) or CP (n=33', '66 participants (40 women and 26 men), 60.35 ± 12.77 years of age, were included in the\xa0intention-to-treat analyses']","['placebo', 'cinnamon patch (CP', 'cinnamon patch treatment', 'CP']","['OAB symptom score (OABSS', 'efficacy and safety', 'patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume', 'alleviating symptoms of overactive bladder', 'OABSS scores', 'USS scores', 'PPBC scores']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0008802', 'cui_str': 'Cinnamomum verum'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008802', 'cui_str': 'Cinnamomum verum'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}]",66.0,0.50229,"Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60).
","[{'ForeName': 'Lih-Lian', 'Initials': 'LL', 'LastName': 'Chen', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; Department of Traditional Chinese Medicine, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan.'}, {'ForeName': 'Yuh-Chiang', 'Initials': 'YC', 'LastName': 'Shen', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; National Taipei University of Nursing and Health Sciences, 365 Mingde Road, Taipei 11219, Taiwan; National Research Institute of Chinese Medicine, Ministry of Health and Welfare, 155-1 Linong Street, Sec. 2, Taipei 11221, Taiwan.'}, {'ForeName': 'Chih-Chun', 'Initials': 'CC', 'LastName': 'Ke', 'Affiliation': 'Department of Urology, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan.'}, {'ForeName': 'Zuha', 'Initials': 'Z', 'LastName': 'Imtiyaz', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan.'}, {'ForeName': 'Hui-I', 'Initials': 'HI', 'LastName': 'Chen', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan.'}, {'ForeName': 'Chin-Hsien', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Traditional Chinese Medicine, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan; Department of Cosmetic Science, Chang Gung University of Science and Technology, 261 Wenhua 1st road, Taoyuan City 33303, Taiwan.'}, {'ForeName': 'Mei-Hsien', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; Graduate Institute of Pharmacognosy, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; Center for Reproductive Medicine & Sciences, Taipei Medical University Hospital, 252 Wuxing Street, Taipei 11031, Taiwan. Electronic address: lmh@tmu.edu.tw.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153380']
1342,33091857,"A standardized polyphenol mixture extracted from poplar-type propolis for remission of symptoms of uncomplicated upper respiratory tract infection (URTI): A monocentric, randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND
The most common symptoms of mild upper respiratory tract infections (URTIs) are sore throat, muffled dysphonia, and swelling and redness of the throat, which result from the inflammation process following acute bacterial or viral infection.
HYPOTHESIS/PURPOSE
As propolis is a natural resinous substance traditionally used to maintain oral cavity and upper respiratory tract health due to its antimicrobial and anti-inflammatory properties, the aim of this study is to evaluate the efficacy of an oral spray based on poplar-type propolis extract with a known and standardized polyphenol content, on the remission of the symptoms associated with mild uncomplicated URTIs.
STUDY DESIGN
A monocentric, randomized, double-blind, placebo-controlled clinical trial was performed.
METHODS
This study was conducted in 122 healthy adults who had perceived mild upper respiratory tract infections. Participants, randomly assigned to receive either propolis oral spray (N = 58) or placebo (N = 64), underwent four visits (baseline = t0, after 3 days = t1 and after 5 days = t2 and after a follow-up of 15 days = t3) in an outpatient setting. Propolis oral spray total polyphenol content was 15 mg/ml. The dosage was 2-4 sprays, corresponding to 12-24 mg of polyphenols, three times for five days. The duration of the study was 8 weeks.
RESULTS
After 3 days of treatment, 83% of subjects treated with propolis oral spray had remission of symptoms, while 72% of subjects in the placebo group had at least one remaining symptom. After five days, all subjects had recovered from all symptoms. This means that resolution from mild uncomplicated URTIs took place two days earlier, instead of taking place in five days as recorded in the control group. There was no relationship between the ingestion of propolis oral spray or placebo and adverse reactions.
CONCLUSION
Propolis oral spray can be used to improve both bacterial and viral uncomplicated URTI symptoms in a smaller number of days without the use of pharmacological treatment, leading to a prompt symptom resolution.",2020,"There was no relationship between the ingestion of propolis oral spray or placebo and adverse reactions.
","['uncomplicated upper respiratory tract infection (URTI', '122 healthy adults who had perceived mild upper respiratory tract infections']","['propolis oral spray (N\xa0=\xa058) or placebo', 'standardized polyphenol mixture extracted from poplar-type propolis', 'placebo']",['remission of symptoms'],"[{'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C1154184', 'cui_str': 'Oral spray'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0522458', 'cui_str': 'Populus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",122.0,0.301597,"There was no relationship between the ingestion of propolis oral spray or placebo and adverse reactions.
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Esposito', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.'}, {'ForeName': 'Emanuele Ugo', 'Initials': 'EU', 'LastName': 'Garzarella', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Bocchino', 'Affiliation': 'Samnium Medical Soc. Cooperative, 82100 Benevento, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""D'Avino"", 'Affiliation': 'Department of Internal Medicine, Hospital Cardarelli, Via Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Caruso', 'Affiliation': 'Department of Internal Medicine, Hospital Cardarelli, Via Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Antonio Riccardo', 'Initials': 'AR', 'LastName': 'Buonomo', 'Affiliation': 'Department of Clinical Medicine and Surgery - Section of Infectious Diseases, University of Naples Federico II, via Sergio Pansini 5, 80131 Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': 'Applied Statistic Unit, Department of Earth and Environmental Sciences, University of Pavia, viale Taramelli 24, 27100 Pavia, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Galeotti', 'Affiliation': 'Department of Life Sciences, University of Modena and Reggio Emilia, Via Campi 213/D, 41121 Modena, Italy.'}, {'ForeName': 'Gian Carlo', 'Initials': 'GC', 'LastName': 'Tenore', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Zaccaria', 'Affiliation': 'B Natural R&D Unit, via Gran Sasso 33, 20011 Corbetta (MI), Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Daglia', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy; International Research Center for Food Nutrition and Safety, Jiangsu University, Zhenjiang 212013, China. Electronic address: maria.daglia@unina.it.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153368']
1343,33109241,Sex differences in fatigability after ischemic preconditioning of non-exercising limbs.,"BACKGROUND
Ischemic preconditioning (IPC) is suggested to decrease fatigability in some individuals but not others. Sex differences in response to IPC may account for this variability and few studies systematically investigated the effects of IPC in men and women. The goal of this study was to determine if time to task failure, perception of pain, and neuromuscular mechanisms of fatigability were altered by IPC in men and women.
METHODS
Ten women (29 ± 5 years old) and 10 men (28 ± 6 years old) performed isometric contractions with the plantar flexor muscles of the dominant leg at 20% of maximal voluntary contraction until task failure. We used a repeated measures design where each individual performed 3 randomized and counterbalanced test sessions: (A) IPC session, cuff inflation and deflation (5 min each repeated 3 times) performed before the exercise by inflating cuffs to the non-dominant leg and arm; (B) sham session, cuffs were inflated for a short period (1 min); and (C) control session, no cuffs were involved.
RESULTS
Compared with control, IPC increased time to task failure in men (mean difference, 5 min; confidence interval (CI) of mean difference, 2.2; 7.8 min; P = 0.01) but not women (mean difference, - 0.6 min; CI of mean difference, - 3.5; 2.4 min; P = 0.51). In men, but not women, the IPC-induced increase in time to task failure was associated with lower response to pressure pain (r = - 0.79). IPC further exposed sex differences in arterial pressure during fatiguing contractions (session × sex: P < 0.05). Voluntary activation, estimated with the twitch interpolation technique, and presynaptic inhibition of leg Ia afferents were not altered after IPC for men and women. The tested variables were not altered with sham.
CONCLUSIONS
The ergogenic effect of IPC on time to task failure was observed only in men and it was associated with reductions in the perception of pain. This pilot data suggest the previously reported inter-individual variability in exercise-induced fatigability after IPC could be a consequence of the sex and individual response to pain.",2020,"Compared with control, IPC increased time to task failure in men (mean difference, 5 min; confidence interval (CI) of mean difference, 2.2; 7.8 min; P = 0.01) but not women (mean difference, - 0.6 min; CI of mean difference, - 3.5; 2.4 min; P = 0.51).","['men and women', 'Ten women (29 ± 5\u2009years old) and 10 men (28 ± 6\u2009years old) performed']","['IPC', 'isometric contractions with the plantar flexor muscles of the dominant leg at 20% of maximal voluntary contraction until task failure', 'Ischemic preconditioning (IPC']","['Voluntary activation, estimated with the twitch interpolation technique, and presynaptic inhibition of leg Ia afferents', 'time to task failure', 'arterial pressure', 'IPC increased time to task failure', 'perception of pain', 'pressure pain', 'time to task failure, perception of pain, and neuromuscular mechanisms of fatigability']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}]",10.0,0.117824,"Compared with control, IPC increased time to task failure in men (mean difference, 5 min; confidence interval (CI) of mean difference, 2.2; 7.8 min; P = 0.01) but not women (mean difference, - 0.6 min; CI of mean difference, - 3.5; 2.4 min; P = 0.51).","[{'ForeName': 'Hugo M', 'Initials': 'HM', 'LastName': 'Pereira', 'Affiliation': 'Department of Health and Exercise Science, University of Oklahoma, 1401 Asp Ave, Norman, OK, 73019, USA. hugomax@ou.edu.'}, {'ForeName': 'Felipe F', 'Initials': 'FF', 'LastName': 'de Lima', 'Affiliation': 'Biomedical Engineering Laboratory/EPUSP, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Bruno M', 'Initials': 'BM', 'LastName': 'Silva', 'Affiliation': 'Department of Physiology, Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'André F', 'Initials': 'AF', 'LastName': 'Kohn', 'Affiliation': 'Biomedical Engineering Laboratory/EPUSP, University of São Paulo, São Paulo, SP, Brazil.'}]",Biology of sex differences,['10.1186/s13293-020-00338-z']
1344,33109244,Assessment of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES
In this study, we investigate the effect of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in patients with COVID-19.
TRIAL DESIGN
The current study is a single-center, randomized, double-blind, placebo-controlled clinical trial with parallel groups.
PARTICIPANTS
The inclusion criteria include male and female patients≥18 years of age, with a confirmed diagnosis of SARS-CoV-2 infection via polymerase chain reaction (PCR) and/or antibody test and with written informed consent to participate in this trial. The exclusion criteria include regular use of any other supplement, severe and critical COVID-19 pneumonia, pregnancy and breastfeeding. This study is being conducted at Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.
INTERVENTION AND COMPARATOR
Patients are randomly assigned to four groups. The first group (A) will take one capsule containing 5 mg of boron compounds twice a day for two weeks. The second group (B) will take one capsule containing 200 mg oleoylethanolamide twice a day for two weeks. The third group (C) will take one capsule containing 5 mg boron compounds with 200 mg oleoylethanolamide twice a day for two weeks, and the fourth group (D) does not receive any additional treatment other than routine treatments. Boron-containing compounds and oleoylethanolamide capsules will be synthesized at Nutrition Research Center of Tabriz University of Medical Sciences.
MAIN OUTCOMES
The primary end point of this study is to investigate the recovery rate of clinical symptoms, including fever, dry cough, and fatigue, as well as preclinical features, including complete blood count (CBC), the erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) profiles within two weeks of randomization.
RANDOMISATION
Patients are randomized into four equal groups in a parallel design (allocation ratio 1:1). A randomized block procedure is used to divide subjects into one of four treatment blocks (A, B, C, and D) by a computer-generated allocation schedule.
BLINDING (MASKING)
The participants and investigators (enrolling, assessing, and analyzing) are blinded to the intervention assignments until the end of the study and data analysis.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
The calculated total sample size is 40 patients, with 10 patients in each group.
TRIAL STATUS
The protocol is Version 1.0, May 17, 2020. Recruitment began May 19, 2020, and is anticipated to be completed by October 19, 2020.
TRIAL REGISTRATION
This clinical trial has been registered by the title of ""Assessment of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in Patients with COVID-19: A double-blind randomized placebo-controlled clinical trial"" in the Iranian Registry of Clinical Trials (IRCT). The registration number is "" IRCT20090609002017N35 "", https://www.irct.ir/trial/48058 . The registration date is 17 May 2020.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","['Patients with COVID-19', 'patients with COVID-19', 'The inclusion criteria include male and female patients≥18 years of age, with a confirmed diagnosis of SARS-CoV-2 infection via polymerase chain reaction (PCR) and/or antibody test and with written informed consent to participate in this trial', '40 patients, with 10 patients in each group', 'Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran']","['oleoylethanolamide', 'placebo', 'oleoylethanolamide supplementation', 'boron-containing compounds and oleoylethanolamide supplementation']","['recovery rate of clinical symptoms, including fever, dry cough, and fatigue, as well as preclinical features, including complete blood count (CBC), the erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) profiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0580327', 'cui_str': 'Antibody studies'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C1454896', 'cui_str': 'oleoylethanolamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006030', 'cui_str': 'Boron'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205198', 'cui_str': 'Compound'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0850149', 'cui_str': 'Dry cough'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",,0.452636,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","[{'ForeName': 'Helda', 'Initials': 'H', 'LastName': 'Tutunchi', 'Affiliation': 'Department of Clinical Nutrition, Nutrition Research Center, School of Nutrition & Food Sciences, Tabriz University of Medical Sciences, Tabriz, 5166614711, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mobasseri', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Pourmoradian', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Soleimanzadeh', 'Affiliation': 'Department of Applied Chemistry, Faculty of Chemistry, University of Tabriz, Tabriz, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Kafil', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Akbari', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Monshikarimi', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Department of Clinical Nutrition, Nutrition Research Center, School of Nutrition & Food Sciences, Tabriz University of Medical Sciences, Tabriz, 5166614711, Iran. ostadrahimi@tbzmed.ac.ir.'}]",Trials,['10.1186/s13063-020-04820-2']
1345,33109246,Evaluation of the efficacy and safety of favipiravir and interferon compared to lopinavir/ritonavir and interferon in moderately ill patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES
We will evaluate the efficacy and safety of favipiravir and interferon beta-1a compared to lopinavir/ritonavir and interferon beta-1a in patients with confirmed COVID-19, who are moderately ill.
TRIAL DESIGN
This is a phase 3, single-center, randomized, open-label, controlled trial with a parallel-group design carried out at Shahid Mohammadi Hospital, Bandar Abbas, Iran.
PARTICIPANTS
All patients with age ≥ 20 years admitted at the Severe Acute Respiratory Syndrome Departments of the Shahid Mohammadi Hospital, Bandar Abbas, Iran, will be screened for the following criteria.
INCLUSION CRITERIA
1. Confirmed diagnosis of infection with SARS-CoV-2 using polymerase chain reaction and/or antibody tests. 2. Moderate COVID-19 pneumonia (via computed tomography and/or X-ray imaging), requiring hospitalization. 3. Hospitalized ≤ 48 h. 4. Signing informed consent and willingness of the participant to accept randomization to any assigned treatment arm.
EXCLUSION CRITERIA
1. Underlying conditions, including chronic hepatitis, cirrhosis, cholestatic liver diseases, cholecystitis, peptic ulcers, acute and chronic renal failure, and peptic ulcers. 2. Severe and critical COVID-19 pneumonia. 3. History of allergy to favipiravir, lopinavir/ritonavir, and interferon beta-1a. 4. Pregnancy and breastfeeding.
INTERVENTION AND COMPARATOR
Intervention group: favipiravir (Zhejiang Hisun, China) with interferon beta-1a (CinnaGen, Iran). This group will receive 1600 mg favipiravir twice a day for the first day and 600 mg twice a day for the following 4 days with five doses of 44 mcg interferon beta-1a every other day.
CONTROL GROUP
lopinavir/ritonavir (Heterd Company, India) with interferon beta-1a (CinnaGen, Iran). This group will receive 200/50 mg lopinavir/ritonavir twice a day for 7 days with five doses of 44 mcg interferon beta-1a every other day. Other supportive and routine care will be the same in both groups.
MAIN OUTCOMES
The primary outcome of the trial is the viral load of SARS-CoV-2 in the nasopharyngeal samples assessed by RT-PCR after 7 days of randomization as well as clinical improvement of fever and O 2 saturation within 7 days of randomization. The secondary outcomes are the length of hospital stay and the incidence of serious adverse drug reactions within 7 days of randomization.
RANDOMIZATION
Eligible patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 10 patients). A web-based system will be used to generate random numbers for the allocation sequence. Each number relates to one of the study arms.
BLINDING (MASKING)
This is an open-label trial without blinding and placebo control.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)
A total of 60 patients will be randomized into two groups (30 patients in the intervention group and 30 patients in the control group).
TRIAL STATUS
The trial protocol is version 1.0, 22 July 2020. Recruitment began on 25 July 2020 and is anticipated to be completed by 25 September 2020.
TRIAL REGISTRATION
Iranian Registry of Clinical Trials (IRCT) IRCT20200506047323N3 . Registered on 22 July 2020.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.",2020,"History of allergy to favipiravir, lopinavir/ritonavir, and interferon beta-1a.","['60 patients', 'Shahid Mohammadi Hospital, Bandar Abbas, Iran', 'patients with confirmed COVID-19, who are moderately ill', 'All patients with age\u2009≥\u200920\u2009years admitted at the Severe Acute Respiratory Syndrome Departments of the Shahid Mohammadi Hospital, Bandar Abbas, Iran, will be screened for the following criteria', 'moderately ill patients with COVID-19']","['lopinavir/ritonavir and interferon', 'favipiravir and interferon', 'GROUP\n\n\nlopinavir/ritonavir', 'lopinavir/ritonavir', 'Intervention group: favipiravir (Zhejiang Hisun, China) with interferon beta-1a (CinnaGen, Iran', 'placebo', 'favipiravir, lopinavir/ritonavir, and interferon beta-1a']","['chronic hepatitis, cirrhosis, cholestatic liver diseases, cholecystitis, peptic ulcers, acute and chronic renal failure, and peptic ulcers', 'length of hospital stay and the incidence of serious adverse drug reactions', 'viral load of SARS-CoV-2 in the nasopharyngeal samples assessed by RT-PCR', 'clinical improvement of fever and O 2 saturation', 'Severe and critical COVID-19 pneumonia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1175175', 'cui_str': 'Severe acute respiratory syndrome'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019189', 'cui_str': 'Chronic hepatitis'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0860204', 'cui_str': 'Cholestatic liver disease'}, {'cui': 'C0008325', 'cui_str': 'Cholecystitis'}, {'cui': 'C0030920', 'cui_str': 'Peptic ulcer'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",60.0,0.170662,"History of allergy to favipiravir, lopinavir/ritonavir, and interferon beta-1a.","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hassaniazad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bazram', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Hassanipour', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fathalipour', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. M.fathalipour@hums.ac.ir.'}]",Trials,['10.1186/s13063-020-04747-8']
1346,33111647,Ethnoracial differences in treatment-seeking veterans with substance use disorders and co-occurring PTSD: Presenting characteristics and response to integrated exposure-based treatment.,"OBJECTIVE
Substance use disorders (SUD) and posttraumatic stress disorder (PTSD) frequently co-occur. While previous research has examined ethnoracial differences among individuals with either SUD or PTSD, little research to date has focused on individuals with co-occurring SUD/PTSD. The current study addresses this gap in the literature.
METHOD
Participants were 79 military veterans (91% male; 38% African American [AA] and 62% White) with current SUD/PTSD who were randomized to receive Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE) or Relapse Prevention (RP). Primary outcomes included substance use and self-reported and clinician-rated PTSD symptoms.
RESULTS
At baseline, AA participants were significantly older, reported greater substance and alcohol use, and tended to report higher PTSD severity than White participants. AA participants evidenced greater decreases in substance and alcohol use during treatment, but greater increases in substance and alcohol use during follow-up as compared to White participants. All participants decreased alcohol consumption during treatment; however, AA participants in the COPE condition and White participants in the RP condition evidenced the steepest decreases in average number of drinks per drinking day (DDD) during treatment. Additionally, White participants receiving RP reported greater increases in DDD during follow-up compared to AA participants.
CONCLUSION
Overall, integrated treatment for co-occurring SUD/PTSD was effective for both AA and White participants; however, some important differences emerged by ethnoracial group. Findings suggest that greater attention to race and ethnicity is warranted to better understand the needs of diverse patients with SUD/PTSD and to optimize treatment outcomes.",2020,"All participants decreased alcohol consumption during treatment; however, AA participants in the COPE condition and White participants in the RP condition evidenced the steepest decreases in average number of drinks per drinking day (DDD) during treatment.","['individuals with either SUD or PTSD', 'treatment-seeking veterans with substance use disorders and co-occurring PTSD', 'Participants were 79 military veterans (91% male; 38% African American [AA] and 62% White) with current SUD/PTSD']",['PTSD and Substance Use Disorders using Prolonged Exposure (COPE) or Relapse Prevention (RP'],"['DDD', 'substance and alcohol use', 'substance use and self-reported and clinician-rated PTSD symptoms', 'alcohol consumption']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",91.0,0.0208936,"All participants decreased alcohol consumption during treatment; however, AA participants in the COPE condition and White participants in the RP condition evidenced the steepest decreases in average number of drinks per drinking day (DDD) during treatment.","[{'ForeName': 'Delisa G', 'Initials': 'DG', 'LastName': 'Brown', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Jarnecke', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Therese K', 'Initials': 'TK', 'LastName': 'Killeen', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}]",Journal of ethnicity in substance abuse,['10.1080/15332640.2020.1836699']
1347,33118716,Randomized controlled trial comparing embryonic quality in rFSH versus hMG in the IVF protocol with GnRH Antagonist.,"OBJECTIVE
The aim of the present study is to investigate embryo quality (score) after controlled ovarian stimulation for IVF using rFSH or hMG with the GnRH antagonist protocol.
METHODS
Open, randomized, single center study. The patients were randomized to receive rFSH or hMG according to randomized cards inside a black envelope with the name of the respective treatment following a computer generated list (85 patients were allocated to rFSH group and 83 patients to hMG group). Inclusion criteria were patients with IVF indication and normal ovarian reserve. Embryo evaluation was performed on day three, after fertilization based on the Graduated Embryo Score (GES).
RESULTS
There were no relevant differences in demographic characteristics. There was no difference in pregnancy rates with 27 (31%) and 25 (30.1%) pregnancies for rFSH and hMG, respectively (p=0.87). The total embryo score was the same for both groups, but the best embryo score was significant higher for the rFSH group (77.33±34.0 x 65.07±33.2 p=0.03). The total number of embryos was statistical different, also in favor of the rFSH group (4.17±3.1 x 3.26±2.4 p=0.04).
CONCLUSION
The total embryo score was the same for both groups, but the best embryo score was significantly higher for the rFSH group. Moreover, rFSH was associated with an increased number of embryos.",2020,"The total embryo score was the same for both groups, but the best embryo score was significant higher for the rFSH group (77.33±34.0 x 65.07±33.2 p=0.03).",['Inclusion criteria were patients with IVF indication and normal ovarian reserve'],"['rFSH versus hMG', 'rFSH or hMG', 'rFSH']","['total embryo score', 'pregnancy rates', 'number of embryos', 'total number of embryos', 'embryo score', 'embryo quality (score', 'Graduated Embryo Score (GES', 'best embryo score']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}]","[{'cui': 'C0025326', 'cui_str': 'human menopausal gonadotrophin'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",85.0,0.163386,"The total embryo score was the same for both groups, but the best embryo score was significant higher for the rFSH group (77.33±34.0 x 65.07±33.2 p=0.03).","[{'ForeName': 'Rita de Cassia Borges', 'Initials': 'RCB', 'LastName': 'Chapon', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Programa de Pós-Graduação em Medicina: Ginecologia e Obstetrícia. Obstetrics and Gynecology Department, Porto Alegre, RS, State, Brazil.'}, {'ForeName': 'Vanessa Krebs', 'Initials': 'VK', 'LastName': 'Genro', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Programa de Pós-Graduação em Medicina: Ginecologia e Obstetrícia. Obstetrics and Gynecology Department, Porto Alegre, RS, State, Brazil.'}, {'ForeName': 'Carlos Augusto Bastos de', 'Initials': 'CAB', 'LastName': 'Souza', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Programa de Pós-Graduação em Medicina: Ginecologia e Obstetrícia. Obstetrics and Gynecology Department, Porto Alegre, RS, State, Brazil.'}, {'ForeName': 'João Sabino', 'Initials': 'JS', 'LastName': 'Cunha-Filho', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Programa de Pós-Graduação em Medicina: Ginecologia e Obstetrícia. Obstetrics and Gynecology Department, Porto Alegre, RS, State, Brazil.'}]",JBRA assisted reproduction,['10.5935/1518-0557.20200064']
1348,33118727,Comparison between the Effects of Bretschneider's HTK Solution and Cold Blood Cardioplegia on Systemic Endothelial Functions in Patients who Undergo Coronary Artery Bypass Surgery: a Prospective Randomized and Controlled Trial.,"OBJECTIVE
To investigate the effects of Bretschneider's histidine-tryptophan-ketoglutarate (HTK) solution and cold blood cardioplegia on systemic endothelial functions.
METHODS
A total of 50 patients who underwent isolated coronary artery bypass surgery between March 2018 and May 2018 were randomly divided into two groups - group 1 (Bretschneider's HTK solution, n=25) and group 2 (cold blood cardioplegia, n=25). Data related to the indicators of endothelial dysfunction were recorded. Flow-mediated dilation was measured together with the assessment of the values of endothelin-1, von Willebrand factor, and asymmetric dimethylarginine to identify endothelial dysfunction. Then, the two groups were compared regarding these values.
RESULTS
The most significant result of our study was that the endothelin-1 level was significantly higher in group 2 than in group 1 (P<0.001). The value of flow-mediated dilation was found to increase to a lesser degree on the postoperative days compared to the value at the day of admission in group 1 (P=0.002 and P=0.030, respectively).
CONCLUSION
Cardiopulmonary bypass leads to endothelial dysfunction. Our results revealed that Bretschneider's HTK solution causes less severe endothelial injury than cold blood cardioplegia.",2020,"The value of flow-mediated dilation was found to increase to a lesser degree on the postoperative days compared to the value at the day of admission in group 1 (P=0.002 and P=0.030, respectively).
","['Patients who Undergo Coronary Artery Bypass Surgery', '50 patients who underwent isolated coronary artery bypass surgery between March 2018 and May 2018']","[""Bretschneider's HTK solution"", ""Bretschneider's histidine-tryptophan-ketoglutarate (HTK) solution and cold blood cardioplegia"", ""Bretschneider's HTK Solution and Cold Blood Cardioplegia"", "" group 1 (Bretschneider's HTK solution, n=25) and group 2 (cold blood cardioplegia""]","['Flow-mediated dilation', 'Systemic Endothelial Functions', 'endothelin-1 level', 'endothelial dysfunction', 'value of flow-mediated dilation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0054039', 'cui_str': 'Bretschneider cardioplegic solution'}, {'cui': 'C0019602', 'cui_str': 'Histidine'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",50.0,0.0289154,"The value of flow-mediated dilation was found to increase to a lesser degree on the postoperative days compared to the value at the day of admission in group 1 (P=0.002 and P=0.030, respectively).
","[{'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Mercan', 'Affiliation': 'Konya Training and Research Hospital Department of Cardiovascular Surgery Konya Turkey Department of Cardiovascular Surgery, Konya Training and Research Hospital, Konya, Turkey.'}, {'ForeName': 'Yuksel', 'Initials': 'Y', 'LastName': 'Dereli', 'Affiliation': 'Necmettin Erbakan University Meram Faculty of Medicine Department of Cardiovascular Surgery Konya Turkey Department of Cardiovascular Surgery, Necmettin Erbakan University, Meram Faculty of Medicine, Konya, Turkey.'}, {'ForeName': 'Cemile', 'Initials': 'C', 'LastName': 'Topcu', 'Affiliation': 'Necmettin Erbakan University Meram Faculty of Medicine Department of Biochemistry Konya Turkey Department of Biochemistry, Necmettin Erbakan University, Meram Faculty of Medicine, Konya, Turkey.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Tanyeli', 'Affiliation': 'Necmettin Erbakan University Meram Faculty of Medicine Department of Cardiovascular Surgery Konya Turkey Department of Cardiovascular Surgery, Necmettin Erbakan University, Meram Faculty of Medicine, Konya, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Isik', 'Affiliation': 'Necmettin Erbakan University Meram Faculty of Medicine Department of Cardiovascular Surgery Konya Turkey Department of Cardiovascular Surgery, Necmettin Erbakan University, Meram Faculty of Medicine, Konya, Turkey.'}, {'ForeName': 'Niyazi', 'Initials': 'N', 'LastName': 'Gormus', 'Affiliation': 'Necmettin Erbakan University Meram Faculty of Medicine Department of Cardiovascular Surgery Konya Turkey Department of Cardiovascular Surgery, Necmettin Erbakan University, Meram Faculty of Medicine, Konya, Turkey.'}, {'ForeName': 'Elifnur Yildirim', 'Initials': 'EY', 'LastName': 'Ozturk', 'Affiliation': 'Necmettin Erbakan University Meram Faculty of Medicine Department of Public Health Konya Turkey Department of Public Health, Necmettin Erbakan University, Meram Faculty of Medicine, Konya, Turkey.'}]",Brazilian journal of cardiovascular surgery,['10.21470/1678-9741-2019-0327']
1349,33091192,INEXAS: A Phase 2 Randomized Trial of On-demand Inhaled Interferon Beta-1a in Severe Asthmatics.,"BACKGROUND
Upper respiratory tract infections (URTIs) are important triggers for asthma exacerbations. We hypothesized that inhalation of the anti-viral cytokine, interferon (IFN)-β, during URTI, could prevent these exacerbations.
OBJECTIVE
To evaluate the efficacy of on-demand inhaled IFN-β1a (AZD9412) to prevent severe asthma exacerbations following symptomatic URTI.
METHODS
This was a randomized, double-blind, placebo-controlled trial in which patients with severe asthma (GINA 4-5; n = 121) reporting URTI symptoms were randomized to 14 days of once-daily nebulized AZD9412 or placebo. The primary endpoint was severe exacerbations during treatment. Secondary endpoints included 6-item asthma control questionnaire (ACQ-6) and lung function. Exploratory biomarkers included IFN-response markers in serum and sputum, blood leucocyte counts and serum inflammatory cytokines.
RESULTS
Following a pre-planned interim analysis, the trial was terminated early due to an unexpectedly low exacerbation rate. Asthma worsenings were generally mild and tended to peak at randomization, possibly contributing to the lack of benefit of AZD9412 on other asthma endpoints. Numerically, AZD9412 did not reduce severe exacerbation rate, ACQ-6, asthma symptom scores or reliever medication use. AZD9412 improved lung function (morning peak expiratory flow; mPEF) by 19.7 L/min. Exploratory post hoc analyses indicated a greater mPEF improvement by AZD9412 in patients with high blood eosinophils (>0.3 × 10 9 /L) at screening and low serum interleukin-18 relative change at pre-treatment baseline. Pharmacodynamic effect of AZD9412 was confirmed using IFN-response markers.
CONCLUSIONS & CLINICAL RELEVANCE
Colds did not have the impact on asthma patients that was expected and, due to the low exacerbation rate, the trial was stopped early. On-demand AZD9412 treatment did not numerically reduce the number of exacerbations, but did attenuate URTI-induced worsening of mPEF. Severe asthma patients with high blood eosinophils or low serum interleukin-18 response are potential subgroups for further investigation of inhaled IFN-β1a.",2020,"We hypothesised that inhalation of the anti-viral cytokine, interferon (IFN)-β, during URTI, could prevent these exacerbations.",['Severe Asthmatics'],['INEXAS'],[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]",[],[],,0.0925001,"We hypothesised that inhalation of the anti-viral cytokine, interferon (IFN)-β, during URTI, could prevent these exacerbations.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McCrae', 'Affiliation': 'Translational Science and Experimental Medicine, Research and Early Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Olsson', 'Affiliation': 'Early Biometrics and Statistical Innovation, Data Science and AI, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Gustafson', 'Affiliation': 'BioPharmaceutical Medical, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Malmgren', 'Affiliation': 'Early Respiratory & Immunology Projects Department, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Aurell', 'Affiliation': 'Early Respiratory & Immunology Clinical Development, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Fagerås', 'Affiliation': 'BioPharmaceutical Medical, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Da Silva', 'Affiliation': 'Early Respiratory & Immunology Clinical Development, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Cavallin', 'Affiliation': 'Translational Science and Experimental Medicine, Early Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Paraskos', 'Affiliation': 'Point of Care Diagnostics, Precision Medicine, Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Karlsson', 'Affiliation': 'Translational Science and Experimental Medicine, Early Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Wingren', 'Affiliation': 'Translational Science and Experimental Medicine, Research and Early Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Monk', 'Affiliation': 'Synairgen Research Ltd, Southampton University Hospital, Southampton, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Marsden', 'Affiliation': 'Synairgen Research Ltd, Southampton University Hospital, Southampton, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Harrison', 'Affiliation': 'Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham City Hospital, Nottingham, UK.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13765']
1350,33091681,Concreteness of thoughts and images during suppression and expression of worry.,"The avoidance theory of worry (Borkovec, Alcaine, & Behar, 2004) posits that the verbal-linguistic (versus imagery-based) nature of worry elicits abstract (versus concrete) processing, which inhibits affective responding and generates a host of negative consequences. Although suppression of worrisome thinking is maladaptive (Purdon, 1999), expression of worry using vivid imagery may increase concreteness of worrisome thinking and facilitate more adaptive emotional responding. The present study examined whether the valence, content, and expression of mentation impacts concreteness of thought. Participants (N = 62) were randomly assigned to verbalize their thoughts while engaging in either verbal-linguistic- or imagery-based mentation about both worrisome and neutral topics. Participants were also randomly assigned to engage in a 5-min period of suppressing or expressing the target stimuli before engaging in 5-min of freely expressing the targets. Verbalizations of mental content were coded for level of abstractness/concreteness. For neutral stimuli, imagery-based mentation led to greater concreteness than did verbal-linguistic mentation; however, for worrisome stimuli, imagery-based mentation did not enhance concreteness. In addition, for neutral (but not worrisome) stimuli, an initial period of suppression was associated with increased concreteness during subsequent expression. Imagery-based mentation about worrisome stimuli may not enhance concreteness; moreover, unlike suppression of neutral stimuli, suppression of worrisome stimuli may maintain, rather than ameliorate, abstractness of thought.",2020,"For neutral stimuli, imagery-based mentation led to greater concreteness than did verbal-linguistic mentation; however, for worrisome stimuli, imagery-based mentation did not enhance concreteness.",['Participants (N\xa0=\xa062'],"['verbalize their thoughts while engaging in either verbal-linguistic- or imagery-based mentation about both worrisome and neutral topics', 'Imagery-based mentation about worrisome stimuli']",['Concreteness of thoughts and images during suppression and expression of worry'],[],"[{'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0233481', 'cui_str': 'Worried'}]",62.0,0.0172364,"For neutral stimuli, imagery-based mentation led to greater concreteness than did verbal-linguistic mentation; however, for worrisome stimuli, imagery-based mentation did not enhance concreteness.","[{'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Jendrusina', 'Affiliation': 'University of Illinois at Chicago, USA; VA Ann Arbor Healthcare System, USA. Electronic address: alexanderjendrusina@gmail.com.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Stevens', 'Affiliation': 'University of Illinois at Chicago, USA.'}, {'ForeName': 'Erica R', 'Initials': 'ER', 'LastName': 'Nahin', 'Affiliation': 'University of Miami, USA.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Legrand', 'Affiliation': 'University of Vermont, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Behar', 'Affiliation': 'City University of New York - Hunter College, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103754']
1351,33091687,Facial emotion recognition in borderline patients is unaffected by acute psychosocial stress.,"Borderline Personality Disorder (BPD) is characterized by difficulties in social cognition and social interactions, which exacerbate under stress. A previous study found better facial emotion recognition (FER) in patients with personality disorders and healthy controls (HC) after stress. We recently reported that emotional empathy scores, i.e. the emotional response to another person's emotional state, were significantly lower in BPD patients than in HC after psychosocial stress. Cognitive empathy scores remained unaltered. The present study aims to further investigate the effect of psychosocial stress induced by the Trier Social Stress Test (TSST) on FER as part of social cognition in patients with BPD. We randomized 43 women with BPD and 46 female HC to either the TSST or a placebo condition. Afterwards, participants were asked in an emotion recognition test to identify emotions in faces showing anger or sadness at low and high intensity. Both groups recognized emotions better at high intensity compared with low intensity. There was no effect of stress on FER performance and we found no difference between groups. This is in line with prior research on social cognition in BPD patients demonstrating that the ability to understand another person's perspective might be unaffected by acute stress.",2020,Cognitive empathy scores remained unaltered.,"['43 women with BPD and 46 female HC to either the TSST or a placebo condition', 'borderline patients', 'patients with personality disorders and healthy controls (HC) after stress', 'patients with BPD', 'Borderline Personality Disorder (BPD', 'BPD patients']",['Trier Social Stress Test (TSST'],"['Cognitive empathy scores', 'FER performance', 'Facial emotion recognition', 'facial emotion recognition (FER']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031212', 'cui_str': 'Personality disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",43.0,0.0136793,Cognitive empathy scores remained unaltered.,"[{'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Graumann', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schulze', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Freie Universität Berlin, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Institute of Cognitive Neuroscience, Department of Cognitive Psychology, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health (BIH), Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany. Electronic address: katja.wingenfeld@charite.de.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.007']
1352,33091706,Methylene blue reduces incidence of early postoperative cognitive disorders in elderly patients undergoing major non-cardiac surgery: An open-label randomized controlled clinical trial.,"STUDY OBJECTIVE
The purpose of the present study was to investigate whether methylene blue (MB) could reduce the incidences of postoperative delirium (POD) and early postoperative cognitive dysfunction (POCD) in elderly patients undergoing major non-cardiac surgery.
DESIGN
Prospective, randomized, open-label clinical trial.
SETTING
University-affiliated hospital.
PATIENTS
Two hundred and forty-eight elderly patients scheduled for non-cardiac surgery.
INTERVENTIONS
Elderly patients undergoing non-cardiac major surgery were randomly assigned to MB group (n = 124), who receiving intravenous infusion of 2 mg/kg MB within 60 min immediately after anesthetic induction, or control group (n = 124), who receiving equal volume saline in the same way.
MEASUREMENTS
All patients were evaluated with delirium and neuropsychological batteries before and after surgery, as well as perioperative adverse events. Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.
MAIN RESULTS
There were total 39 cases(15.7%)experienced POD. The incidence of POD in MB group was significantly less than that in control group (7.3% vs. 24.2%, OR = 0.24, 95%CI: 0.11-0.53, p < 0.001). The incidence of early POCD at postoperative 7th day in MB group was also less than that in control group (16.1% vs. 40.2%, OR = 0.30, 95% CI: 0.16-0.57, p < 0.001). The adverse events were comparable in both groups. In addition, there was no significant correlation between POD/POCD and levels of SOD or HCY.
CONCLUSION
We conclude that intraoperative intravenous 2 mg/kg MB could significantly reduce the incidences of POD and early POCD in elderly surgical patients, while not remarkably increase incidence of perioperative adverse events, suggesting MB may be clinically effective and safe for prevention of early postoperative neurocognitive disorders.",2020,"Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.
","['Two hundred and forty-eight elderly patients scheduled for non-cardiac surgery', 'elderly patients undergoing major non-cardiac surgery', 'elderly surgical patients', 'University-affiliated hospital', 'Elderly patients undergoing non-cardiac major surgery']","['methylene blue (MB', 'Methylene blue', 'intravenous infusion of 2\xa0mg/kg\xa0MB within 60\xa0min immediately after anesthetic induction, or control group (n\xa0=\xa0124), who receiving equal volume saline', 'MB']","['POD/POCD and levels of SOD or HCY', 'incidences of POD and early POCD', 'incidence of early POCD', 'postoperative delirium (POD) and early postoperative cognitive dysfunction (POCD', 'incidence of POD', 'delirium and neuropsychological batteries', 'adverse events', 'perioperative adverse events', 'Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY', 'early postoperative cognitive disorders']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C4721773', 'cui_str': 'Postoperative cognitive dysfunction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0451331', 'cui_str': 'Neuropsychological battery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]",248.0,0.0572685,"Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.
","[{'ForeName': 'Yixu', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Anesthesiology, Shanghai Cancer Center, Fudan University, Shanghai 200032, PR China.'}, {'ForeName': 'Ruijing', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Shitong', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychiatry, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Shanghai Cancer Center, Fudan University, Shanghai 200032, PR China; Department of Oncology, Shanghai Medical College, Fudan University,Shanghai 200032, PR China. Electronic address: snapzhang@aliyun.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110108']
1353,33091760,The social curse: Evidence for a moderating effect of shared social identity on contagious stress reactions.,"Contagious stress describes the transmission of a stress response from a distressed individual (target) to an uninvolved observer. Building on social identity theory, we hypothesize that a shared social identity between the observer and the target as compared to a personal identity increases the likelihood of contagious endocrine and psychological stress responses. Participants underwent the experiment in groups of four or five individuals. After experimentally inducing either a shared social identity or a personal identity, one participant in each group (N target = 27) was randomly chosen to undergo the Trier Social Stress Test (TSST), while being observed by the rest of the group (N observer = 89). Salivary cortisol and psychological stress responses were assessed repeatedly during the experiment. As predicted, the likelihood of cortisol stress reactions was significantly higher in the social identity condition (25 %) as compared to the personal identity condition (7 %). No effect of our manipulation on psychological stress responses was found. We also tested whether observers' trait empathy moderates contagious stress and found no support for this moderation.",2020,"As predicted, the likelihood of cortisol stress reactions was significantly higher in the social identity condition (25 %) as compared to the personal identity condition (7 %).",[],['Trier Social Stress Test (TSST'],"['Salivary cortisol and psychological stress responses', 'psychological stress responses', 'likelihood of cortisol stress reactions']",[],"[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0016664', 'cui_str': 'Stress fracture'}]",,0.00992355,"As predicted, the likelihood of cortisol stress reactions was significantly higher in the social identity condition (25 %) as compared to the personal identity condition (7 %).","[{'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Schury', 'Affiliation': 'Justus-Liebig-University Giessen, Germany. Electronic address: Valerie.A.Schury@psychol.uni-giessen.de.'}, {'ForeName': 'Urs M', 'Initials': 'UM', 'LastName': 'Nater', 'Affiliation': 'University of Vienna, Austria.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Häusser', 'Affiliation': 'Justus-Liebig-University Giessen, Germany.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104896']
1354,33092632,"""Early transfusion of convalescent plasma in older patients with COVID-19 to prevent disease progression: A structured summary of a study protocol for a randomised controlled trial"".","OBJECTIVES
The primary objective is to demonstrate that COVID-19 convalescent plasma (CCP) prevents progression to severe pneumonia in elderly COVID-19 pneumonia patients with chronic comorbidities. Secondary objectives are to demonstrate that CCP decreases the viral load in nasopharyngeal swabs and increases the anti-SARS-CoV-2 antibody titre in recipients.
TRIAL DESIGN
This is a randomized, open-label, parallel group, phase II/III study with a superiority framework. The trial starts with a screening phase II designed with two-tailed alpha=0.2. In case of positive results, the trial will proceed in a formally comparative phase III (alpha=0.05).
PARTICIPANTS
Adult patients with confirmed or suspected COVID-19 who are at risk according to CDC definition are eligible. Inclusion criteria are all the following: age ≥ 65; pneumonia at CT scan; PaO2/FiO2 ≥300 mmHg; presence of one or more comorbidities; signed informed consent. Exclusion criteria are one of the following: age < 65; PaO2/FiO2 < 300 mmHg; pending cardiopulmonary arrest; refusal to blood product transfusions; severe IgA deficiency; any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion. The trial is being conducted at three reference COVID-19 centres in the middle of Italy.
INTERVENTION AND COMPARATOR
Intervention: COVID-19 Convalescent Plasma (CCP) in addition to standard therapy. Patients receive three doses (200 ml/day on 3 consecutive days) of ABO matched CCP. Comparator: Standard therapy MAIN OUTCOMES: A. Primary outcome for Phase II: Proportion of patients without progression in severity of pulmonary disease, defined as worsening of 2 points in the ordinal scale of WHO by day 14. B. Primary outcome for Phase III: Proportion of patients without progression in severity of pulmonary disease, defined as worsening of 2 points in the ordinal scale of WHO by day 14. Secondary outcomes for Phase III: Decreased viral load on nasopharyngeal swab at days 6, 9 and 14; Decreased viremia at days 6 and 9; Increased antibody titer against SARS-CoV2 at days 30 and 60; Proportion of patients with negative of SARS-CoV2 nasopharyngeal swab at day 30; Length of hospital stay; Mortality rate at day 28; Total plasma related adverse event (day 60); Total non-plasma related adverse events (day 60); Severe adverse events (SAE) (day 60).
RANDOMISATION
Treatment allocation is randomized with a ratio 1:1 in both phase II and phase III. Randomization sequences will be generated at Fondazione Policlinico Gemelli IRCCS through the RedCap web application. Randomized stratification is performed according to age (under/over 80 years), and sex.
BLINDING (MASKING)
None, this is an open-label trial.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
Phase II: 114 patients (57 per arm). Phase III: 182 patients (91 per arm) TRIAL STATUS: The trial recruitment started on May 27, 2020. The anticipated date of recruitment completion is April 30, 2021. The protocol version is 2 (May 10, 2020).
TRIAL REGISTRATION
The trial has been registered on ClinicalTrials.gov (May 5, 2020). The Identifier number is NCT04374526 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Decreased viral load on nasopharyngeal swab at days 6, 9 and 14; Decreased viremia at days 6 and 9; Increased antibody titer against SARS-CoV2 at days 30 and 60; Proportion of patients with negative of SARS-CoV2 nasopharyngeal swab at day 30; Length of hospital stay; Mortality rate at day 28; Total plasma related adverse event (day 60); Total non-plasma related adverse events (day 60); Severe adverse events (SAE) (day 60).
","['older patients with COVID-19 to prevent disease progression', 'Exclusion criteria are one of the following: age < 65; PaO2/FiO2 < 300 mmHg; pending cardiopulmonary arrest; refusal to blood product transfusions; severe IgA deficiency; any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion', 'elderly COVID-19 pneumonia patients with chronic comorbidities', 'age (under/over 80 years), and sex', 'Phase III: 182 patients (91 per arm', 'Inclusion criteria are all the following: age ≥ 65; pneumonia at CT scan; PaO2/FiO2 ≥300 mmHg; presence of one or more comorbidities; signed informed consent', 'Adult patients with confirmed or suspected COVID-19 who are at risk according to CDC definition are eligible']","['Comparator', 'COVID-19 convalescent plasma (CCP', 'CCP']","['Phase II: Proportion of patients without progression in severity of pulmonary disease, defined as worsening of 2 points in the ordinal scale of WHO', 'viral load in nasopharyngeal swabs and increases the anti-SARS-CoV-2 antibody titre', 'COVID-19 Convalescent Plasma (CCP', 'viremia', 'hospital stay; Mortality rate', 'Phase III: Proportion of patients without progression in severity of pulmonary disease, defined as worsening of 2 points in the ordinal scale of WHO', 'antibody titer against SARS-CoV2']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0600228', 'cui_str': 'Cardiorespiratory arrest'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0162538', 'cui_str': 'Immunoglobulin A deficiency'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439070', 'cui_str': 'III'}]",,0.130479,"Decreased viral load on nasopharyngeal swab at days 6, 9 and 14; Decreased viremia at days 6 and 9; Increased antibody titer against SARS-CoV2 at days 30 and 60; Proportion of patients with negative of SARS-CoV2 nasopharyngeal swab at day 30; Length of hospital stay; Mortality rate at day 28; Total plasma related adverse event (day 60); Total non-plasma related adverse events (day 60); Severe adverse events (SAE) (day 60).
","[{'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Teofili', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. luciana.teofili@unicatt.it.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Landolfi', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Cingolani', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Antinori', 'Affiliation': 'Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Vecchiet', 'Affiliation': 'Presidio Ospedaliero S.S. Annunziata, ASL Lanciano -Vasto-Chieti, Università di Chieti, Chieti, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Sanguinetti', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gasbarrini', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Pasciuto', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Orlando', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Lamonica', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}]",Trials,['10.1186/s13063-020-04821-1']
1355,33092653,The clinical effect of Nano micelles containing curcumin as a therapeutic supplement in patients with COVID-19 and the immune responses balance changes following treatment: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES
To investigates the effectiveness of curcumin-containing Nanomicelles as a therapeutic supplement in the treatment of patients with COVID-19 and its effect on immune responses balance changes following treatment.
TRIAL DESIGN
This study is conducted as a prospective, placebo-controlled with parallel group, single-center randomized clinical trial on COVID-19 patients.
PARTICIPANTS
Patients are selected from the COVID-19 ward of Shahid Mohammadi Hospital in Bandar Abbas, Iran.
INCLUSION CRITERIA
1. Real time PCR-approved positive COVID-19 test. 2. Both gender 3. Age between 18 and 75 years 4. Signing a written consent 5. Lack of participation in other clinical trials Exclusion criteria: 1. Pregnancy or lactation 2. Allergy to turmeric or curcumin 3. Smoking 4. Patient connected to the ventilator 5. SaO2 less than 90% or PaO2 less than 8 kPa 6. Having comorbidities (such as severe renal failure, Glomerular filtration rate less than 30 ml/min, liver failure, Congestive heart failure, or Chronic obstructive pulmonary disease) 7. History of gallstones 8. History of gastritis or active gastrointestinal ulcer INTERVENTION AND COMPARATOR: In addition to the routine standard treatments for COVID-19, in the intervention group, 40mg nanomicelles containing curcumin (SinaCurcumin Capsule, Exir Nano Sina Company, Iran), four times per day (after breakfast, lunch, dinner and before bedtime) and in the placebo group as the control group, capsules with the same appearance and characteristics (Placebo capsules, Exir Nano Sina Company, Iran) are prescribed for two weeks.
MAIN OUTCOMES
The effectiveness of Nano micelles containing curcumin treatment will be evaluated as daily clinical examinations of patients in both groups and, on days 0, 7 and 14, complete clinical symptoms and laboratory findings including peripheral blood and serum parameters such as inflammatory markers will be measured and recorded. Moreover, in order to evaluate the balance of immune responses changes following treatments, serum level of IFN-γ, IL-17, Il-4 and TGF-β serum cytokines will be measured in both groups at time points of 0, 7 and 14 days post treatment. Gene expression of t-bet, GATA-3, FoxP3 and ROR- γT will also be measured at mentioned time points to assess the shift of T helper1, T helper2, T regulatory and T helper 17 immune responses following treatment.
RANDOMISATION
Randomized trials will be performed on 40 COVID-19 patients which will be randomized using encoded sealed boxes with computer generated random digits with 1:1 allocation ratio. In order to randomization, placebo and SinaCurcumin Capsules will be numbered first by computer generated random digits. SinaCurcumin and placebo will then be stored and numbered in sealed packages based on generated random numbers. Finally, according to the order in which patients enter the study, packages are given to patients based on their number.
BLINDING (MASKING)
The present study will be blind for all patients, physicians and nurses, laboratory technicians and statisticians.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
A total of 40 patients will be included in the study, 20 of them will be randomly assigned to the intervention group and 20 to the placebo group.
TRIAL STATUS
This is Version 1.0 of protocol dated 21 May 2020. The recruitment was started June 24, 2020 and is expected to be completed by October 31, 2020.
TRIAL REGISTRATION
This present clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT) with the registration code of ""IRCT20200611047735N1"", https://www.irct.ir/trial/48843 . Dated: 19 June 2020.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Gene expression of t-bet, GATA-3, FoxP3 and ROR- γT will also be measured at mentioned time points to assess the shift of T helper1, T helper2, T regulatory and T helper 17 immune responses following treatment.
","['patients with COVID-19 and the immune responses balance changes following treatment', 'Having comorbidities (such as severe renal failure, Glomerular filtration rate less than 30 ml/min, liver failure, Congestive heart failure, or Chronic obstructive pulmonary disease) 7', '40 patients', 'all patients, physicians and nurses, laboratory technicians and statisticians', '40 COVID-19 patients', 'COVID-19 patients', 'Patients are selected from the COVID-19 ward of Shahid Mohammadi Hospital in Bandar Abbas, Iran', 'Age between 18 and 75 years 4']","['SinaCurcumin and placebo', 'placebo', 'curcumin-containing Nanomicelles', 'control group, capsules with the same appearance and characteristics (Placebo capsules, Exir Nano Sina Company, Iran', 'placebo and SinaCurcumin Capsules']","['Gene expression of t-bet, GATA-3, FoxP3 and ROR- γT', 'serum level of IFN-γ, IL-17, Il-4 and TGF-β serum cytokines']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0086517', 'cui_str': 'Laboratory technician'}, {'cui': 'C0334957', 'cui_str': 'Statistician'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C1307598', 'cui_str': 'GATA3 protein, human'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",40.0,0.354737,"Gene expression of t-bet, GATA-3, FoxP3 and ROR- γT will also be measured at mentioned time points to assess the shift of T helper1, T helper2, T regulatory and T helper 17 immune responses following treatment.
","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hassaniazad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Behnaz Rahnama', 'Initials': 'BR', 'LastName': 'Inchehsablagh', 'Affiliation': 'Student Research Committee, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Kamali', 'Affiliation': 'Student Research Committee, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Abdolali', 'Initials': 'A', 'LastName': 'Tousi', 'Affiliation': 'Student Research Committee, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Eftekhar', 'Affiliation': 'Endocrinology and Metabolism Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mahmoud Reza', 'Initials': 'MR', 'LastName': 'Jaafari', 'Affiliation': 'Nanotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fathalipour', 'Affiliation': 'Endocrinology and Metabolism Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Nikoofal-Sahlabadi', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Gouklani', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Hesam', 'Initials': 'H', 'LastName': 'Alizade', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Amin Reza', 'Initials': 'AR', 'LastName': 'Nikpoor', 'Affiliation': 'Molecular Medicine Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. nikpoora@hums.ac.ir.'}]",Trials,['10.1186/s13063-020-04824-y']
1356,33093056,Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial).,"OBJECTIVE
To investigate the effectiveness of using convalescent plasma to treat moderate coronavirus disease 2019 (covid-19) in adults in India.
DESIGN
Open label, parallel arm, phase II, multicentre, randomised controlled trial.
SETTING
39 public and private hospitals across India.
PARTICIPANTS
464 adults (≥18 years) admitted to hospital (screened 22 April to 14 July 2020) with confirmed moderate covid-19 (partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO 2 /FiO 2 ) ratio between 200 mm Hg and 300 mm Hg or a respiratory rate of more than 24/min with oxygen saturation 93% or less on room air): 235 were assigned to convalescent plasma with best standard of care (intervention arm) and 229 to best standard of care only (control arm).
INTERVENTIONS
Participants in the intervention arm received two doses of 200 mL convalescent plasma, transfused 24 hours apart. The presence and levels of neutralising antibodies were not measured a priori; stored samples were assayed at the end of the study.
MAIN OUTCOME MEASURE
Composite of progression to severe disease (PaO 2 /FiO 2 <100 mm Hg) or all cause mortality at 28 days post-enrolment.
RESULTS
Progression to severe disease or all cause mortality at 28 days after enrolment occurred in 44 (19%) participants in the intervention arm and 41 (18%) in the control arm (risk difference 0.008 (95% confidence interval -0.062 to 0.078); risk ratio 1.04, 95% confidence interval 0.71 to 1.54).
CONCLUSION
Convalescent plasma was not associated with a reduction in progression to severe covid-19 or all cause mortality. This trial has high generalisability and approximates convalescent plasma use in real life settings with limited laboratory capacity. A priori measurement of neutralising antibody titres in donors and participants might further clarify the role of convalescent plasma in the management of covid-19.
TRIAL REGISTRATION
Clinical Trial Registry of India CTRI/2020/04/024775.",2020,"CONCLUSION
Convalescent plasma was not associated with a reduction in progression to severe covid-19 or all cause mortality.","['moderate covid-19 in adults in India', '464 adults (≥18 years) admitted to hospital (screened 22 April to 14 July 2020) with confirmed moderate covid-19 (partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO 2 /FiO 2 ) ratio between 200 mm Hg and 300 mm Hg or a respiratory rate of more than 24/min with oxygen saturation 93% or less on room air): 235 were assigned to', 'moderate coronavirus disease 2019 (covid-19) in adults in India', '39 public and private hospitals across India']","['convalescent plasma with best standard of care (intervention arm) and 229 to best standard of care only (control arm', 'convalescent plasma']","['cause mortality', 'presence and levels of neutralising antibodies']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0033173', 'cui_str': 'Private hospital'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}]",464.0,0.327069,"CONCLUSION
Convalescent plasma was not associated with a reduction in progression to severe covid-19 or all cause mortality.","[{'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Clinical Trial and Health Systems Research Unit, Indian Council of Medical Research, V Ramalingaswamy Bhawan, PO Box 4911, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'Clinical Trial and Health Systems Research Unit, Indian Council of Medical Research, V Ramalingaswamy Bhawan, PO Box 4911, Ansari Nagar, New Delhi, 110029, India aparna.sinha.deb@icmr.gov.in.'}, {'ForeName': 'Gunjan', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Clinical Trial and Health Systems Research Unit, Indian Council of Medical Research, V Ramalingaswamy Bhawan, PO Box 4911, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Pranab', 'Initials': 'P', 'LastName': 'Chatterjee', 'Affiliation': 'Clinical Trial and Health Systems Research Unit, Indian Council of Medical Research, V Ramalingaswamy Bhawan, PO Box 4911, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Bhatnagar', 'Affiliation': 'ICMR School of Public Health, Indian Council of Medical Research - National Institute of Epidemiology, Chennai, Tamil, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Malhotra', 'Affiliation': 'Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.m3939']
1357,33093216,Effects of metformin on disease flares in patients with systemic lupus erythematosus: post hoc analyses from two randomised trials.,"OBJECTIVE
To confirm that metformin prevents flares in patients with SLE with low disease activity, we performed a post hoc analysis combining our previous two randomised trials.
METHODS
Post hoc analyses were performed on data from the open-labelled proof-of-concept trial (n=113, ChiCTR-TRC-12002419) and placebo-controlled 'Met Lupus' trial (n=140, NCT02741960) comparing the efficacy of metformin versus placebo/nil add-on to standard therapy in patients with SLE with low disease activity (SELENA-SLEDAI ≤4). The primary endpoint was defined by the SELENA-SLEDAI Flare Index at 12-month follow-up. A subgroup analysis was performed.
RESULTS
Overall, 201 eligible patients were included, with 99 allocated to metformin group and 102 allocated to the placebo/nil group. By 12 months of follow-up, 21 patients (21.2%) flared in the metformin group, as compared with 36 (35.3%) in the placebo/nil group (p=0.027, risk ratio=0.68, 95% CI 0.46 to 0.96). Subgroup analysis showed that patients with negative anti-dsDNA antibody and normal complement at baseline, and a disease duration <5 years with concomitant use of hydroxychloroquine had a better response to metformin.
CONCLUSION
Post hoc pooled analyses suggested that metformin reduced subsequent disease flares in patients with SLE with low disease activity, especially for serologically quiescent patients.",2020,The primary endpoint was defined by the SELENA-SLEDAI Flare Index at 12-month follow-up.,"['201 eligible patients were included, with 99 allocated to', 'patients with SLE with low disease activity', 'patients with SLE with low disease activity (SELENA-SLEDAI ≤4', 'patients with systemic lupus erythematosus', 'patients with SLE']","['hydroxychloroquine', 'metformin versus placebo/nil add-on to standard therapy', 'metformin', 'placebo', 'placebo/nil group']","['disease flares', 'subsequent disease flares', 'SELENA-SLEDAI Flare Index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442734', 'cui_str': 'Nil'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",201.0,0.230682,The primary endpoint was defined by the SELENA-SLEDAI Flare Index at 12-month follow-up.,"[{'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Shikai', 'Initials': 'S', 'LastName': 'Geng', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haiting', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Huijing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Wan', 'Affiliation': 'Rheumatology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Liangjing', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Teng', 'Affiliation': 'Pathology, Immunology, and Laboratory Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Morel', 'Affiliation': 'Pathology, Immunology, and Laboratory Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Rheumatology, Renji Hospital South Campus, Shanghai Jiaotong University School of Medicine, Shanghai, China ye_shuang2000@163.com.'}]",Lupus science & medicine,['10.1136/lupus-2020-000429']
1358,33095032,Cardiac and Kidney Benefits of Empagliflozin in Heart Failure Across the Spectrum of Kidney Function: Insights from the EMPEROR-Reduced Trial.,"Background: In EMPEROR-Reduced, empagliflozin reduced cardiovascular death or HF hospitalization, total HF hospitalizations, and slowed the progressive decline in kidney function in patients with HF and a reduced ejection fraction (HFrEF), with and without diabetes. We aim to study the effect of empagliflozin on cardiovascular and kidney outcomes across the spectrum of kidney function. Methods: In this pre-specified analysis, patients were categorized by the presence or absence of CKD at baseline (eGFR<60ml/min/1.73m 2 or UACR>300mg/g). The primary and key secondary outcomes were (1) a composite of cardiovascular death or HF hospitalization (primary outcome); (2) total HF hospitalizations, and (3) eGFR slope. The direct impact on kidney events was investigated by a prespecified composite kidney outcome (defined as a sustained profound decline in eGFR, chronic dialysis or transplant). The median follow-up was 16 months. Results: 3730 patients were randomized to empagliflozin or placebo, of whom 1978 (53%) had CKD. Empagliflozin reduced the primary outcome and total HF hospitalizations in patients with and without CKD: primary outcome HR=0.78 (95%CI=0.65-0.93) and HR=0.72 (95%CI=0.58-0.90), respectively; interaction P=0.63. Empagliflozin slowed the slope of eGFR decline by 1.11 (0.23-1.98) ml/min/1.73m 2 /year in patients with CKD and by 2.41 (1.49-3.32) ml/min/1.73m2/year in patients without CKD. The risk of the composite kidney outcome was reduced similarly in patients with and without CKD: HR=0.53 (95%CI=0.31-0.91) and HR=0.46 (95%CI=0.22-0.99), respectively. The effect of empagliflozin on the primary composite outcome and the key secondary outcomes was consistent across a broad range of baseline kidney function, measured by clinically relevant eGFR subgroups or by albuminuria, including patients with eGFR as low as 20 ml/min/1.73m 2 . Empagliflozin was well tolerated in CKD patients. Conclusions: In EMPEROR-reduced, empagliflozin had a beneficial effect on the key efficacy outcomes and slowed the rate of kidney function decline in patients with and without CKD and regardless of the severity of kidney impairment at baseline. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03057977.",2020,"In EMPEROR-Reduced, empagliflozin reduced cardiovascular death or HF hospitalization, total HF hospitalizations, and slowed the progressive decline in kidney function in patients with HF and a reduced ejection fraction (HFrEF), with and without diabetes.","['patients with and without CKD: primary outcome', 'CKD patients', '3730 patients']","['empagliflozin or placebo', 'Empagliflozin', 'empagliflozin', 'CKD']","['slope of eGFR decline', 'cardiovascular death or HF hospitalization, total HF hospitalizations', 'risk of the composite kidney outcome', 'kidney events', 'total HF hospitalizations', 'rate of kidney function decline', 'composite of cardiovascular death or HF hospitalization (primary outcome); (2) total HF hospitalizations, and (3) eGFR slope', 'broad range of baseline kidney function', 'cardiovascular and kidney outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",3730.0,0.23048,"In EMPEROR-Reduced, empagliflozin reduced cardiovascular death or HF hospitalization, total HF hospitalizations, and slowed the progressive decline in kidney function in patients with HF and a reduced ejection fraction (HFrEF), with and without diabetes.","[{'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM 1116, CHRU de Nancy, FCRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM 1116, CHRU de Nancy, FCRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Zeller', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK), and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi School of Medicine, Jackson, MS.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens, Greece.'}, {'ForeName': 'Sibylle Jenny', 'Initials': 'SJ', 'LastName': 'Hauske', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany; Vth Department of Medicine, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany; Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Egon', 'Initials': 'E', 'LastName': 'Pfarr', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Schnee', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Division of Nephrology, University Hospital, Würzburg, Germany.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas TX; Imperial College, London, UK.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.051685']
1359,33095849,Effect of Regional Citrate Anticoagulation vs Systemic Heparin Anticoagulation During Continuous Kidney Replacement Therapy on Dialysis Filter Life Span and Mortality Among Critically Ill Patients With Acute Kidney Injury: A Randomized Clinical Trial.,"Importance
Although current guidelines suggest the use of regional citrate anticoagulation (which involves the addition of a citrate solution to the blood before the filter of the extracorporeal dialysis circuit) as first-line treatment for continuous kidney replacement therapy in critically ill patients, the evidence for this recommendation is based on few clinical trials and meta-analyses.
Objective
To determine the effect of regional citrate anticoagulation, compared with systemic heparin anticoagulation, on filter life span and mortality.
Design, Setting, and Participants
A parallel-group, randomized multicenter clinical trial in 26 centers across Germany was conducted between March 2016 and December 2018 (final date of follow-up, January 21, 2020). The trial was terminated early after 596 critically ill patients with severe acute kidney injury or clinical indications for initiation of kidney replacement therapy had been enrolled.
Interventions
Patients were randomized to receive either regional citrate anticoagulation (n = 300), which consisted of a target ionized calcium level of 1.0 to 1.40 mg/dL, or systemic heparin anticoagulation (n = 296), which consisted of a target activated partial thromboplastin time of 45 to 60 seconds, for continuous kidney replacement therapy.
Main Outcomes and Measures
Coprimary outcomes were filter life span and 90-day mortality. Secondary end points included bleeding complications and new infections.
Results
Among 638 patients randomized, 596 (93.4%) (mean age, 67.5 years; 183 [30.7%] women) completed the trial. In the regional citrate group vs systemic heparin group, median filter life span was 47 hours (interquartile range [IQR], 19-70 hours) vs 26 hours (IQR, 12-51 hours) (difference, 15 hours [95% CI, 11 to 20 hours]; P < .001). Ninety-day all-cause mortality occurred in 150 of 300 patients vs 156 of 296 patients (Kaplan-Meier estimator percentages, 51.2% vs 53.6%; unadjusted difference, -2.4% [95% CI, -10.5% to 5.8%]; unadjusted hazard ratio, 0.91 [95% CI, 0.72 to 1.13]; unadjusted P = .38; adjusted difference, -6.1% [95% CI, -12.6% to 0.4%]; primary adjusted hazard ratio, 0.79 [95% CI, 0.63 to 1.004]; primary adjusted P = .054). Of 38 prespecified secondary end points, 34 showed no significant difference. Compared with the systemic heparin group, the regional citrate group had significantly fewer bleeding complications (15/300 [5.1%] vs 49/296 [16.9%]; difference, -11.8% [95% CI, -16.8% to -6.8%]; P < .001) and significantly more new infections (204/300 [68.0%] vs 164/296 [55.4%]; difference, 12.6% [95% CI, 4.9% to 20.3%]; P = .002).
Conclusions and Relevance
Among critically ill patients with acute kidney injury receiving continuous kidney replacement therapy, anticoagulation with regional citrate, compared with systemic heparin anticoagulation, resulted in significantly longer filter life span. The trial was terminated early and was therefore underpowered to reach conclusions about the effect of anticoagulation strategy on mortality.
Trial Registration
ClinicalTrials.gov Identifier: NCT02669589.",2020,"Ninety-day all-cause mortality occurred in 150 of 300 patients vs 156 of 296 patients (Kaplan-Meier estimator percentages, 51.2% vs 53.6%; unadjusted difference, -2.4% [95% CI, -10.5% to 5.8%]; unadjusted hazard ratio, 0.91","['Critically Ill Patients With Acute Kidney Injury', '26 centers across Germany was conducted between March 2016 and December 2018 (final date of follow-up, January 21, 2020', '638 patients randomized, 596 (93.4%) (mean age, 67.5 years; 183 [30.7%] women) completed the trial', 'critically ill patients with acute kidney injury receiving', 'critically ill patients', '596 critically ill patients with severe acute kidney injury or clinical indications for initiation of kidney replacement therapy had been enrolled']","['systemic heparin', 'regional citrate anticoagulation (n\u2009=\u2009300), which consisted of a target ionized calcium level of 1.0 to 1.40 mg/dL, or systemic heparin anticoagulation', 'continuous kidney replacement therapy, anticoagulation with regional citrate', 'systemic heparin anticoagulation', 'regional citrate anticoagulation', 'continuous kidney replacement therapy', 'Regional Citrate Anticoagulation vs Systemic Heparin Anticoagulation']","['bleeding complications and new infections', 'cause mortality', 'bleeding complications', 'filter life span and mortality', 'longer filter life span', 'median filter life span', 'Dialysis Filter Life Span and Mortality', 'mortality', 'filter life span and 90-day mortality', 'new infections']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0373561', 'cui_str': 'Calcium electrolyte'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439633', 'cui_str': 'New infection'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0870809', 'cui_str': 'Lifespan'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",638.0,0.468136,"Ninety-day all-cause mortality occurred in 150 of 300 patients vs 156 of 296 patients (Kaplan-Meier estimator percentages, 51.2% vs 53.6%; unadjusted difference, -2.4% [95% CI, -10.5% to 5.8%]; unadjusted hazard ratio, 0.91","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University of Münster, Münster, Germany.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Küllmar', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University of Münster, Münster, Germany.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Kindgen-Milles', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Wempe', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University of Münster, Münster, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Gerss', 'Affiliation': 'Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Brandenburger', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dimski', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Heinrich-Heine University of Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Bartosz', 'Initials': 'B', 'LastName': 'Tyczynski', 'Affiliation': 'Department of Nephrology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jahn', 'Affiliation': 'Department of Nephrology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Mülling', 'Affiliation': 'Department of Nephrology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Mehrländer', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rosenberger', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Marx', 'Affiliation': 'Department of Intensive Care Medicine, University of Aachen, Aachen, Germany.'}, {'ForeName': 'Tim Philipp', 'Initials': 'TP', 'LastName': 'Simon', 'Affiliation': 'Department of Intensive Care Medicine, University of Aachen, Aachen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Jaschinski', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Augsburg, Augsburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Deetjen', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Augsburg, Augsburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Putensen', 'Affiliation': 'University Hospital Bonn, Department of Anesthesiology and Intensive Care Medicine, Bonn, Germany.'}, {'ForeName': 'Jens-Christian', 'Initials': 'JC', 'LastName': 'Schewe', 'Affiliation': 'University Hospital Bonn, Department of Anesthesiology and Intensive Care Medicine, Bonn, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kluge', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Intensive Care, Hamburg, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Jarczak', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Intensive Care, Hamburg, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Slowinski', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bodenstein', 'Affiliation': 'Universitätsmedizin Mainz, Department of Anesthesiology, Mainz, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Meybohm', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wirtz', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Helios Klinikum Bad Saarow, Bad Saarow, Germany.'}, {'ForeName': 'Onnen', 'Initials': 'O', 'LastName': 'Moerer', 'Affiliation': 'Department of Anesthesiology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kortgen', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Bagshaw', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kellum', 'Affiliation': 'Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Meersch', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University of Münster, Münster, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.18618']
1360,33096271,Pain sensitivity and autonomic nervous system parameters as predictors of dry eye symptoms after LASIK.,"PURPOSE
Differences in pain processing and autonomic function among patients have been implicated in the development of chronic pain after surgery. This study was designed to evaluate whether pain and autonomic metrics predict severity of chronic dry eye (DE) symptoms after LASIK, as there is increasing evidence that DE symptoms may be manifestations of persistent post-operative ocular pain.
METHODS
Secondary analysis of prospective randomized clinical trial. Patients were treated with either pregabalin or placebo. As no significant differences in DE symptoms were detected by treatment allocation at six months, all participants were grouped together for the present analyses. Subjects were evaluated pre-LASIK with regard to evoked pain sensitivity (utilizing quantitative sensory testing), autonomic metrics and DE and ocular pain symptoms (via validated questionnaires). Measures of DE and ocular pain were assessed post-LASIK, and the Dry Eye Questionnaire 5 (DEQ5) score 6-months after surgery was the primary outcome of interest.
RESULTS
43 individuals were randomized to pregabalin (n = 21) or placebo (n = 22). 42 completed the 6-month visit. Several baseline autonomic metrics correlated with 6-month post-operative DEQ5 scores, including lower systolic (r -0.37, p = 0.02) and diastolic blood pressure (r -0.32, p = 0.04). Ocular pain at 6 months was also negatively correlated with blood pressure (r -0.31, p = 0.047). The presence of painful aftersensations was a significant predictor of chronic DE symptoms at 6 months (mean DEQ5 scores: 8.0 ± 1.9 versus 5.0 ± 5.0, p = 0.009).
CONCLUSIONS
Heightened parasympathetic tone and prolonged pain sensitivity measured prior to surgery predicted greater DE symptom severity 6 months after LASIK.
TRIAL REGISTRATION
NCT02701764.",2020,"Heightened parasympathetic tone and prolonged pain sensitivity measured prior to surgery predicted greater DE symptom severity 6 months after LASIK.
","['43 individuals', 'dry eye symptoms after LASIK']","['pregabalin', 'placebo', 'pregabalin or placebo']","['DE and ocular pain', 'Ocular pain', 'blood pressure', 'Heightened parasympathetic tone and prolonged pain sensitivity', 'lower systolic', 'evoked pain sensitivity (utilizing quantitative sensory testing), autonomic metrics and DE and ocular pain symptoms (via validated questionnaires', 'DE symptoms', 'chronic DE symptoms', 'Dry Eye Questionnaire 5 (DEQ5) score 6-months', 'diastolic blood pressure']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0151827', 'cui_str': 'Pain in eye'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",43.0,0.287792,"Heightened parasympathetic tone and prolonged pain sensitivity measured prior to surgery predicted greater DE symptom severity 6 months after LASIK.
","[{'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Levitt', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Galor', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami, Miami, FL, USA; Department of Ophthalmology, Miami Veterans Administration Medical Center, Miami, FL, USA. Electronic address: agalor@med.miami.edu.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Small', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Feuer', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Felix', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, University of Miami, Miami, FL, USA; Research Service, Miami Veterans Administration Medical Center, Miami, FL, USA.'}]",The ocular surface,['10.1016/j.jtos.2020.10.004']
1361,33096291,Augmenting exposure therapy with pre-extinction fear memory reactivation and deepened extinction: A randomized controlled trial.,"BACKGROUND
Pre-extinction fear memory reactivation (PE-FMR) and deepened extinction (DE) enhance long-term extinction of shock-conditioned fear, and may also enhance long-term extinction of naturally acquired fear. Preliminary data suggest that PE-FMR may additionally boost the speed of fear reduction during exposure therapy.
DESIGN
Randomized controlled trial, factorial design.
METHODS
Participants with elevated fears of either spiders or snakes were randomized to (1) exposure therapy alone (n = 41), (2) exposure therapy + PE-FMR (n = 42), (3) exposure therapy + DE (n = 41), or (4) exposure therapy + PE-FMR + DE (n = 42). Participants were assessed at baseline, post-treatment, and one-week follow-up on subjective and behavioral indices of phobia. Because treatment length was tailored to speed of fear reduction, survival analyses were used to examine the speed of fear reduction during treatment.
RESULTS
DE did not improve clinical outcomes at post-treatment or follow-up, whereas PE-FMR produced more rapid fear reduction and was able to achive equivalent outcomes even when the duration of exposure therapy (tailored to speed of fear reduction) was shortened by an average of 21%.
CONCLUSIONS
Data suggest that PE-FMR is a promising strategy for reducing the overall duration of exposure-based therapies.
CLINICAL TRIAL REGISTRATION
(clinicaltrials.gov)NCT02160470.",2020,"RESULTS
DE did not improve clinical outcomes at post-treatment or follow-up, whereas PE-FMR produced more rapid fear reduction and was able to achive equivalent outcomes even when the duration of exposure therapy (tailored to speed of fear reduction) was shortened by an average of 21%.
",['Participants with elevated fears of either spiders or snakes'],"['Augmenting exposure therapy with pre-extinction fear memory reactivation and deepened extinction', 'PE-FMR', 'exposure therapy alone (n\xa0=\xa041), (2) exposure therapy\xa0+\xa0PE-FMR (n\xa0=\xa042), (3) exposure therapy\xa0+\xa0DE (n\xa0=\xa041), or (4) exposure therapy\xa0+\xa0PE-FMR\xa0+\xa0DE']","['clinical outcomes', 'rapid fear reduction']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0037382', 'cui_str': 'Suborder Serpentes'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",42.0,0.0830397,"RESULTS
DE did not improve clinical outcomes at post-treatment or follow-up, whereas PE-FMR produced more rapid fear reduction and was able to achive equivalent outcomes even when the duration of exposure therapy (tailored to speed of fear reduction) was shortened by an average of 21%.
","[{'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Lancaster', 'Affiliation': 'Department of Psychology, University of Texas. 108 E. Dean Keeton Stop A8000. Austin, TX, USA; Department of Psychology, University of Nevada, Reno. 1664 N. Virginia Street, Mail Stop 0298. Reno, NV, USA. Electronic address: cynthialancaster@unr.edu.'}, {'ForeName': 'Marie-H', 'Initials': 'MH', 'LastName': 'Monfils', 'Affiliation': 'Department of Psychology, University of Texas. 108 E. Dean Keeton Stop A8000. Austin, TX, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Telch', 'Affiliation': 'Department of Psychology, University of Texas. 108 E. Dean Keeton Stop A8000. Austin, TX, USA. Electronic address: telch@austin.utexas.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103730']
1362,33096332,"The role of expressive suppression and cognitive reappraisal in cognitive behavioral therapy for social anxiety disorder: A study of self-report, subjective, and electrocortical measures.","BACKGROUND
Contemporary models of cognitive behavioral therapy (CBT) for social anxiety disorder (SAD) emphasize emotion dysregulation as a core impairment whose reduction may play a causal role in psychotherapy. The current study examined changes in use of emotion regulation strategies as possible mechanisms of change in CBT for SAD. Specifically, we examined changes in expressive suppression and cognitive reappraisal during CBT and whether these changes predict treatment outcome.
METHODS
Patients (n = 34; 13 females; Mean age = 28.36 (6.97)) were allocated to 16-20 sessions of CBT. An electrocortical measure of emotion regulation and a clinician-rated measure of SAD were administered monthly. Self-report measures of emotion regulation and social anxiety were administered weekly. Multilevel models were used to examine changes in emotion regulation during treatment and cross-lagged associations between emotion regulation and anxiety.
RESULTS
CBT led to decreased suppression frequency, increased reappraisal self-efficacy, and decreased unpleasantness for SAD-related pictures (ps < .05). At post-treatment, patients were equivalent to healthy controls in terms of suppression frequency and subjective reactivity to SAD-related stimuli. Gains were maintained at 3-months follow-up. Decreases in suppression frequency and electrocortical reactivity to SAD-related pictures predicted lower subsequent anxiety but not the other way around (ps < .05). Lower anxiety predicted greater subsequent increases in reappraisal self-efficacy.
LIMITATIONS
The lack of a control group precludes conclusions regarding mechanisms specificity.
CONCLUSIONS
Decreased frequency of suppression is a potential mechanism of change in CBT for SAD.",2020,"At post-treatment, patients were equivalent to healthy controls in terms of suppression frequency and subjective reactivity to SAD-related stimuli.","['Patients (n\xa0', 'social anxiety disorder', '34; 13 females; Mean age\xa0=\xa028.36 (6.97']","['cognitive behavioral therapy (CBT', 'expressive suppression and cognitive reappraisal in cognitive behavioral therapy']","['emotion regulation', 'emotion regulation and social anxiety', 'suppression frequency and electrocortical reactivity to SAD-related pictures predicted lower subsequent anxiety', 'suppression frequency, increased reappraisal self-efficacy, and decreased unpleasantness for SAD-related pictures', 'expressive suppression and cognitive reappraisal', 'reappraisal self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.0112977,"At post-treatment, patients were equivalent to healthy controls in terms of suppression frequency and subjective reactivity to SAD-related stimuli.","[{'ForeName': 'Yogev', 'Initials': 'Y', 'LastName': 'Kivity', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel. Electronic address: yogev.kivity@biu.ac.il.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Elizur', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Huppert', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.021']
1363,33115675,"Clinical Outcomes and Plasma Concentrations of Baloxavir Marboxil and Favipiravir in COVID-19 Patients: An Exploratory Randomized, Controlled Trial.","BACKGROUND
Effective antiviral drugs for COVID-19 are still lacking. This study aims to evaluate the clinical outcomes and plasma concentrations of baloxavir acid and favipiravir in COVID-19 patients.
METHODS
Favipiravir and baloxavir acid were evaluated for their antiviral activity against SARS-CoV-2 in vitro before the trial initiation. We conducted an exploratory trial with 3 arms involving hospitalized adult patients with COVID-19. Patients were randomized assigned in a 1:1:1 ratio into baloxavir marboxil group, favipiravir group, and control group. The primary outcome was the percentage of subjects with viral negative by Day 14 and the time from randomization to clinical improvement. Virus load reduction, blood drug concentration and clinical presentation were also observed. The trial was registered with Chinese Clinical Trial Registry (ChiCTR 2000029544).
RESULTS
Baloxavir acid showed antiviral activity in vitro with the half-maximal effective concentration (EC 50 ) of 5.48 μM comparable to arbidol and lopinavir, but favipiravir didn't demonstrate significant antiviral activity up to 100 μM. Thirty patients were enrolled. The percentage of patients who turned viral negative after 14-day treatment was 70%, 77%, and 100% in the baloxavir marboxil, favipiravir, and control group respectively, with the medians of time from randomization to clinical improvement was 14, 14 and 15 days, respectively. One reason for the lack of virological effect and clinical benefits may be due to insufficient concentrations of these drugs relative to their antiviral activities. One of the limitations of this study is the time from symptom onset to randomization, especially in the baloxavir marboxil and control groups, which is higher than the favipiravir group.
CONCLUSIONS
Our findings could not prove a benefit of addition of either baloxavir marboxil or favipiravir under the trial dosages to the existing standard treatment.",2020,"RESULTS
Baloxavir acid showed antiviral activity in vitro with the half-maximal effective concentration (EC 50 ) of 5.48 μM comparable to arbidol and lopinavir, but favipiravir didn't demonstrate significant antiviral activity up to 100 μM. Thirty patients were enrolled.","['hospitalized adult patients with COVID-19', 'COVID-19 Patients', 'COVID-19 patients', '100 μM. Thirty patients were enrolled']","['baloxavir marboxil group, favipiravir group, and control group']","['antiviral activity', 'percentage of patients who turned viral negative', 'Virus load reduction, blood drug concentration and clinical presentation', 'Plasma Concentrations of Baloxavir Marboxil and Favipiravir', 'percentage of subjects with viral negative']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C4688747', 'cui_str': 'Baloxavir marboxil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1261478', 'cui_str': 'Viral load'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018938', 'cui_str': 'Hematologic agent'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C4688747', 'cui_str': 'Baloxavir marboxil'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}]",,0.102533,"RESULTS
Baloxavir acid showed antiviral activity in vitro with the half-maximal effective concentration (EC 50 ) of 5.48 μM comparable to arbidol and lopinavir, but favipiravir didn't demonstrate significant antiviral activity up to 100 μM. Thirty patients were enrolled.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Hangping', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Xingjiang', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Junwei', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Kaijin', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Luo', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Lingjuan', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Qingwei', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Tingbo', 'Initials': 'T', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.'}, {'ForeName': 'Yunqing', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'State Key Laboratory for diagnosis and treatment of infectious diseases, Key Laboratory for Drug Evaluation and Clinical Research of Zhejiang Province, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China. Electronic address: qiuyq@zju.edu.cn.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105631']
1364,33118193,The implications of noncompliance for randomized trials with partial nesting due to group treatment.,"Analyses of trials of group administered treatments require an identifier for therapy group to account for clustering by group. All patients randomized to receive the group administered treatment could be assigned an intended group identifier following randomization. Alternatively, an actual group could be based on those patients that comply with group therapy. We investigate the implications for intention-to-treat (ITT) analyses of using either the intended or actual group to adjust for the clustering effect. We also consider causal models using the actual group. A simulation study showed that ITT estimates based on random effects models or GEE with an exchangeable correlation matrix performed much better when using the intended group than the actual group. OLS with robust standard errors performed well with both. Most compliance average causal effect (CACE) models performed well. While practical constraints of the clinical setting may determine the choice between an intended or actual group analyses, it is desirable to record both. An ITT analysis using mixed models can then be fitted using the intended group with data generation assumptions checked by a causal model using the actual group. Where an ITT analysis is based on the actual group, worse outcome for never-takers than compliers may allow one to infer that some estimators are biased toward no treatment effect. The work here is motivated and illustrated by a trial of a group therapy, but also has relevance to trials with treatment related clustering due to therapist examples of which include physical and talking therapies or surgery.",2020,OLS with robust standard errors performed well with both.,[],[],[],[],[],[],,0.0313269,OLS with robust standard errors performed well with both.,"[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Centre for Biostatistics, Division of Population Health, School of Health Sciences, University of Manchester, Manchester, UK.'}]",Statistics in medicine,['10.1002/sim.8778']
1365,33124984,Effects of a Mobile and Web App (Thought Spot) on Mental Health Help-Seeking Among College and University Students: Randomized Controlled Trial.,"BACKGROUND
Mental health disorders are the most prevalent health issues among postsecondary students, yet few solutions to this emerging crisis exist. While mobile health technologies are touted as promising solutions for the unmet mental health needs of these students, the efficacy of these tools remains unclear. In response to these gaps, this study evaluates Thought Spot, a mobile and web app created through participatory design research.
OBJECTIVE
The goal of the research is to examine the impact of Thought Spot on mental health and wellness help-seeking intentions, behaviors, attitudes, self-stigma, and self-efficacy among postsecondary students in Canada.
METHODS
A 2-armed randomized controlled trial involving students from three postsecondary institutions was conducted. Students were eligible if they were aged 17 to 29 years, enrolled in full-time or part-time studies, functionally competent in English, and had access to a compatible digital device. The usual care group received a mental health services information pamphlet. The intervention group received the Thought Spot app on their digital device. Thought Spot is a standalone app that allows users to add, review, and search crowdsourced information about nearby mental health and wellness services. Users can also track their mood on the app. Outcomes were self-assessed through questionnaires collected at baseline and 3 and 6 months. The primary outcome was change in formal help-seeking intentions from baseline to 6 months, measured by the General Help-Seeking Questionnaire. A mixed-effects model was used to compare the impact of usual care and intervention on the primary outcome (formal help-seeking intentions). Secondary outcomes included changes in informal help-seeking intentions and help-seeking behaviors, help-seeking attitudes, self-stigma, and self-efficacy.
RESULTS
A total of 481 students were randomized into two groups: 240 to usual care, and 241 to the intervention group. There were no significant differences in help-seeking intentions between the usual care and intervention groups over 6 months (F 2,877 =0.85; P=.43, f=0.04). Both groups demonstrated similar increases in formal help-seeking intentions at 3 and 6 months (F 2,877 =23.52; P<.001, f=0.21). Compared with males, females sought more help from formal resources (OR 1.86; 95% CI 1.22 to 2.83, P=.001). Females were less likely to seek help from informal sources than males (OR 0.80; 95% CI 0.22 to 0.73, P<.001).
CONCLUSIONS
Prompting postsecondary students about mental health and help-seeking appears to increase help-seeking intentions. mHealth interventions may be as effective as information pamphlets in increasing formal help-seeking but may confer a small advantage in driving help-seeking from informal sources. Although there is enthusiasm, developers and health policy experts should exercise caution and thoroughly evaluate these types of digital tools. Future studies should explore the cost-effectiveness of digital interventions and develop strategies for improving their efficacy.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03412461; https://clinicaltrials.gov/ct2/show/NCT03412461.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.2196/resprot.6446.",2020,"Compared with males, females sought more help from formal resources (OR 1.86; 95% CI 1.22 to 2.83, P=.001).","['students from three postsecondary institutions was conducted', 'A total of 481 students', 'Students were eligible if they were aged 17 to 29 years, enrolled in full-time or part-time studies, functionally competent in English, and had access to a compatible digital device', 'postsecondary students in Canada', 'Mental Health Help-Seeking Among College and University Students']","['mental health services information pamphlet', 'Mobile and Web App (Thought Spot', 'Thought Spot app on their digital device']","['help-seeking intentions', 'formal help-seeking intentions', 'change in formal help-seeking intentions from baseline to 6 months, measured by the General Help-Seeking Questionnaire', 'changes in informal help-seeking intentions and help-seeking behaviors, help-seeking attitudes, self-stigma, and self-efficacy']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0682294', 'cui_str': 'Part-time employment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683301', 'cui_str': 'Help-Seeking Behavior'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",481.0,0.160705,"Compared with males, females sought more help from formal resources (OR 1.86; 95% CI 1.22 to 2.83, P=.001).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wiljer', 'Affiliation': 'UHN Digital, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lo', 'Affiliation': 'UHN Digital, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Sanches', 'Affiliation': 'Krembil Centre for Neuroinformatics, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Hollenberg', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Alexxa', 'Initials': 'A', 'LastName': 'Abi-Jaoudé', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Chaim', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Cleverley', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Wanrudee', 'Initials': 'W', 'LastName': 'Isaranuwatchai', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Levinson', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Robb', 'Affiliation': 'Health and Wellness, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Howard W', 'Initials': 'HW', 'LastName': 'Wong', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Aristotle', 'Initials': 'A', 'LastName': 'Voineskos', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}]",Journal of medical Internet research,['10.2196/20790']
1366,33124987,Effectiveness of a Peer-Led Web-Based Intervention to Improve General Self-Efficacy in Using Dating Apps Among Young Adults: Randomized Clustered Trial.,"BACKGROUND
Online dating apps are popular platforms for seeking romance and sexual relationships among young adults. As mobile apps can easily gain access to a pool of strangers (""new friends"") at any time and place, it leads to heightened sexual health risks and privacy concerns.
OBJECTIVE
This study aimed to evaluate the effectiveness of a peer-led web-based intervention for online dating apps to prepare Chinese college students so that they have better self-efficacy when using dating apps.
METHODS
An open clustered randomized controlled trial was conducted among students from three colleges (The University of Hong Kong, Hang Seng University of Hong Kong, and Yijin Programme of Vocational Training College) in Hong Kong. Students aged 17 to 27 years who attended common core curriculum or general education were randomized into intervention and control groups. The intervention material, developed with high peer engagement, included four short videos, an interactive scenario game, and a risk assessment tool. An existing website promoting physical activities and healthy living was used as a control. Using the information, motivation, and behavioral skills (IMB) approach to design the evaluation, questionnaires covering participants' sociodemographics and dating app characteristics, as well as the general self-efficacy scale (GSE) as the primary outcome and the risk propensity scale (RPS) as the secondary outcome were administered before, immediately after, and at 1 month after the intervention. Intention-to-treat analysis was adopted, and between-group differences were assessed using the Mann-Whitney U test. A post-hoc multiple linear regression model was used to examine the correlates of the GSE and RPS.
RESULTS
A total of 578 eligible participants (290 in the intervention group and 288 in the control group) participated in the study with 36 lost to follow-up. There were more female participants (318/542, 58.7%) than male participants in the sample, reflecting the distribution of college students. Over half of the participants (286/542, 52.8%) reported the following reasons for using dating apps: being curious (170/498, 34.1%), trying to make new friends (158/498, 31.7%), and finding friends with similar interests (121/498, 24.3%). Overall, the participants in the intervention group reported favorable experiences when compared with the finding in the control group. There was significant improvement in the GSE score and reduction in the RPS score (P<.001) in the intervention group. University of Hong Kong students were more susceptible to risk reduction after the intervention when compared with students from the other two institutions.
CONCLUSIONS
The online intervention was effective in improving general self-efficacy and reducing risk tendency among young students. Future work is needed to determine if this approach is cost-effective and such behavioral change is sustainable.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03685643; https://clinicaltrials.gov/ct2/show/NCT03685643.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.1186/s13063-018-3167-5.",2020,"University of Hong Kong students were more susceptible to risk reduction after the intervention when compared with students from the other two institutions.
","['Young Adults', 'young adults', '578 eligible participants (290 in the intervention group and 288 in the control group) participated in the study with 36 lost to follow-up', 'female participants (318/542, 58.7%) than male participants in the sample, reflecting the distribution of college students', 'young students', 'Chinese college students', 'students from three colleges (The University of Hong Kong, Hang Seng University of Hong Kong, and Yijin Programme of Vocational Training College) in Hong Kong', 'Students aged 17 to 27 years who attended common core curriculum or general education']","['peer-led web-based intervention', 'Peer-Led Web-Based Intervention']","['GSE score', 'general self-efficacy', 'RPS score', 'risk reduction', 'risk propensity scale (RPS']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0544691', 'cui_str': 'Hanging'}, {'cui': 'C0204116', 'cui_str': 'Vocational training'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",578.0,0.0906271,"University of Hong Kong students were more susceptible to risk reduction after the intervention when compared with students from the other two institutions.
","[{'ForeName': 'William Cw', 'Initials': 'WC', 'LastName': 'Wong', 'Affiliation': 'Department of General Practice, University of Hong Kong-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Wai Han', 'Initials': 'WH', 'LastName': 'Sun', 'Affiliation': 'Sticky Rice Love Ltd., Hong Kong, China.'}, {'ForeName': 'Shu Ming Cheryl', 'Initials': 'SMC', 'LastName': 'Chia', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina at Chapel Hill - Project China, Guangzhou, China.'}, {'ForeName': 'William Ph', 'Initials': 'WP', 'LastName': 'Mak', 'Affiliation': 'Vocational Training Council, Hong Kong, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Communication, Faculty of Social Sciences, University of Macau, Macau, Macao.'}, {'ForeName': 'Kitty Wai Ying', 'Initials': 'KWY', 'LastName': 'Choi', 'Affiliation': 'Sticky Rice Love Ltd., Hong Kong, China.'}, {'ForeName': 'Stephanie Tsz Hei', 'Initials': 'STH', 'LastName': 'Lau', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Eric Yuk Fai', 'Initials': 'EYF', 'LastName': 'Wan', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong, Hong Kong, China.'}]",Journal of medical Internet research,['10.2196/16378']
1367,33124989,"A Mobile App, KhunLook, to Support Thai Parents and Caregivers With Child Health Supervision: Development, Validation, and Acceptability Study.","BACKGROUND
In Thailand, children born in government hospitals receive a maternal and child health handbook (MCHH). However, when a new MCHH edition is released, those with the previous editions do not have access to the updated information. A mobile app is an appealing platform to fill this gap. We developed a mobile app called ""KhunLook"" as an interactive electronic MCHH intended to assist parents in child health supervision.
OBJECTIVE
This study describes the user requirements and development of the KhunLook mobile app, validity of parents' growth assessments, and parents' evaluation of feasibility and acceptability of the app.
METHODS
Phase 1 was a qualitative study using individual interviews. The interview data were used to revise the prototype. In phase 2, parents were randomly assigned to assess their children's growth with the app or the MCHH. The outcomes were compared to those of the physician's assessment, and congruence was determined. In phase 3, parents evaluated the feasibility and acceptability of the app in comparison to the MCHH through a web-based survey.
RESULTS
Four health care providers and 8 parents participated in phase 1. Two themes were identified: (1) the mobile app potentially counters parents' infrequent use of the MCHH with accuracy, attractiveness, convenience, and simplicity, and (2) health supervision needs to be standard, up-to-date, and understandable. KhunLook was publicly launched with a family page and 7 key features: growth and nutrition, development, immunizations, oral health, reminders for the next appointment, memories, and health advice. In phase 2, 56 parents participated in the growth parameter assessments; 34 were in the App group and 22 in the MCHH group. The outcomes of the growth parameter assessments between parents and physicians in both the App and MCHH groups were not significantly different. The congruence proportions were higher in the App group for weight and head circumference, but the differences were not statistically significant. In phase 3, 356 parents from all over Thailand participated in a web-based survey. Parents rated the app feasibility as ""very easy to easy"" to use at higher proportions than the MCHH in all health assessment domains (growth, development, and immunizations) and ease-of-use domains with statistical significance (P<.001). The KhunLook app received a significantly higher mean score (8.59/10) than the MCHH (7.6/10) (P<.001). Most parents (317/356, 89.0%) preferred the app over MCHH. Further, 93.5% (333/356) of the parents stated that they would continue to use the app and 96.9% (345/356) would recommend others to use it.
CONCLUSIONS
KhunLook, a Thai mobile app for child health supervision, was developed, validated for growth assessments, and was well accepted for ease-of-use by parents. Further studies should be conducted with a large scale of users, and the impact of this app on health behaviors and health outcomes must be evaluated.",2020,The outcomes of the growth parameter assessments between parents and physicians in both the App and MCHH groups were not significantly different.,"['356 parents from all over Thailand participated in a web-based survey', '56 parents participated in the growth parameter assessments; 34 were in the App group and 22 in the MCHH group', 'In Thailand, children born in government hospitals receive a maternal and child health handbook (MCHH']",[],"['MCHH with accuracy, attractiveness, convenience, and simplicity, and (2) health supervision needs', 'weight and head circumference', 'feasibility and acceptability']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0596654', 'cui_str': 'Handbooks'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0337960', 'cui_str': 'Government hospital'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0596654', 'cui_str': 'Handbooks'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C1454365', 'cui_str': 'Simplicity (adhesive)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",356.0,0.0284046,The outcomes of the growth parameter assessments between parents and physicians in both the App and MCHH groups were not significantly different.,"[{'ForeName': 'Rosawan', 'Initials': 'R', 'LastName': 'Areemit', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Pagakrong', 'Initials': 'P', 'LastName': 'Lumbiganon', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Chanyut', 'Initials': 'C', 'LastName': 'Suphakunpinyo', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Arunee', 'Initials': 'A', 'LastName': 'Jetsrisuparb', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Sumitr', 'Initials': 'S', 'LastName': 'Sutra', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kunwadee', 'Initials': 'K', 'LastName': 'Sripanidkulchai', 'Affiliation': 'Department of Computer Engineering, Faculty of Engineering, Chulalongkorn University, Bangkok, Thailand.'}]",JMIR mHealth and uHealth,['10.2196/15116']
1368,33093598,Population pharmacokinetics of levodopa gel infusion in Parkinson's disease: effects of entacapone infusion and genetic polymorphism.,"Levodopa-entacapone-carbidopa intestinal gel (LECIG) provides continuous drug delivery through intrajejunal infusion. The aim of this study was to characterize the population pharmacokinetics of levodopa following LECIG and levodopa-carbidopa intestinal gel (LCIG) infusion to investigate suitable translation of dose from LCIG to LECIG treatment, and the impact of common variations in the dopa-decarboxylase (DDC) and catechol-O-methyltransferase (COMT) genes on levodopa pharmacokinetics. A non-linear mixed-effects model of levodopa pharmacokinetics was developed using plasma concentration data from a double-blind, cross-over study of LCIG compared with LECIG in patients with advanced Parkinson's disease (n = 11). All patients were genotyped for rs4680 (polymorphism of the COMT gene), rs921451 and rs3837091 (polymorphisms of the DDC gene). The final model was a one compartment model with a high fixed absorption rate constant, and a first order elimination, with estimated apparent clearances (CL/F), of 27.9 L/h/70 kg for LCIG versus 17.5 L/h/70 kg for LECIG, and apparent volume of distribution of 74.4 L/70 kg. Our results thus suggest that the continuous maintenance dose of LECIG, on a population level, should be decreased by approximately 35%, to achieve similar drug exposure as with LCIG. An effect from entacapone was identified on all individuals, regardless of COMT rs4680 genotype. The individuals with higher DDC and COMT enzyme activity showed tendencies towards higher levodopa CL/F. The simultaneous administration of entacapone to LCIG administration results in a 36.5% lower apparent levodopa clearance, and there is a need for lower continuous maintenance doses, regardless of patients' COMT genotype.",2020,"The individuals with higher DDC and COMT enzyme activity showed tendencies towards higher levodopa CL/F. The simultaneous administration of entacapone to LCIG administration results in a 36.5% lower apparent levodopa clearance, and there is a need for lower continuous maintenance doses, regardless of patients' COMT genotype.","[""Parkinson's disease"", ""patients with advanced Parkinson's disease (n\u2009=\u200911""]","['levodopa following LECIG and levodopa-carbidopa intestinal gel (LCIG', 'entacapone', 'Levodopa-entacapone-carbidopa intestinal gel (LECIG', 'levodopa gel infusion', 'LECIG', 'levodopa pharmacokinetics']",['levodopa clearance'],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0165921', 'cui_str': 'entacapone'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.0927242,"The individuals with higher DDC and COMT enzyme activity showed tendencies towards higher levodopa CL/F. The simultaneous administration of entacapone to LCIG administration results in a 36.5% lower apparent levodopa clearance, and there is a need for lower continuous maintenance doses, regardless of patients' COMT genotype.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Senek', 'Affiliation': 'Department of Neuroscience, Neurology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Nyholm', 'Affiliation': 'Department of Neuroscience, Neurology, Uppsala University, Uppsala, Sweden. dag.nyholm@neuro.uu.se.'}, {'ForeName': 'E I', 'Initials': 'EI', 'LastName': 'Nielsen', 'Affiliation': 'Department of Pharmacy, Uppsala University, Uppsala, Sweden.'}]",Scientific reports,['10.1038/s41598-020-75052-2']
1369,33096028,Diagnostic value of parameters from a spot urine sample for renal potassium loss in hypokalemia.,"BACKGROUND
We assessed the value of 1) a spot urine test for diagnosing hypokalemia caused by renal potassium loss, and 2) actual 24-hour urine potassium excretion (24 hUK-actual) for diagnosing hypokalemia caused by renal potassium loss in patients treated with potassium supplementation. The study population was from Southwest China.
METHODS
Patients with hypokalemia were divided into 2 groups: hypokalemia caused by renal potassium loss (n = 67) and hypokalemia caused by extrarenal potassium loss (n = 63). Urine potassium concentration (UK), urine creatinine concentration (UCr), urine potassium-creatinine ratio (UK/UCr), fractional excretion of potassium (FEK), transtubular potassium concentration gradient (TTKG), and 24-h urine potassium excretion (24 hUK-calculated) were derived from spot urine samples collected on admission, before initiation of therapy. Patients received intravenous potassium chloride 0.4 or 0.6 g/h. 24 hUK-actual was detected in patients whose serum potassium did not return to normal after 24 h of therapy.
RESULTS
Patients with hypokalemia caused by renal potassium loss had significantly higher UK, UK/UCr, FEK, TTKG and 24 hUK-calculated compared to patients with hypokalemia caused by extrarenal potassium loss (P < 0.05). FEK predicted renal potassium loss in hypokalemia with high accuracy at a cut-off of 9.29% (sensitivity, 80.6%; specificity, 85.7%). The area under the curve for 24 hUK-actual in predicting renal potassium loss in patients with hypokalemia treated with low or high-dose potassium chloride infusion were 0.939 or 0.956, respectively. On the spot urine test, FEK showed the highest correlation with 24 hUK-actual during low or high dose potassium chloride infusion (r = 0.831, p < 0.001 or r = 0.764, p < 0.001).
CONCLUSIONS
FEK from a spot urine sample represents a convenient and reliable parameter to predict renal potassium loss in patients with hypokalemia.",2020,"On the spot urine test, FEK showed the highest correlation with 24 hUK-actual during low or high dose potassium chloride infusion (r=0.831, p<0.001 or r=0.764, p<0.001).
","['Patients with hypokalemia were divided into 2 groups: hypokalemia caused by renal potassium loss (n=67) and hypokalemia caused by extrarenal potassium loss (n=63', 'hypokalemia', 'The study population was from Southwest China', 'patients with hypokalemia', 'patients with hypokalemia treated with low or high-dose']","['potassium chloride infusion', 'intravenous potassium chloride', 'potassium supplementation']","['renal potassium loss', 'Urine potassium concentration (UK), urine creatinine concentration (UCr), urine potassium-creatinine ratio (UK/UCr), fractional excretion of potassium (FEK), transtubular potassium concentration gradient (TTKG), and 24-h urine potassium excretion (24 hUK-calculated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0032825', 'cui_str': 'Potassium Chloride'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0360652', 'cui_str': 'Potassium-containing product in parenteral dose form'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0561938', 'cui_str': 'Potassium supplementation'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0202195', 'cui_str': 'Potassium measurement, urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1318439', 'cui_str': 'Creatinine measurement, urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}]",,0.0248461,"On the spot urine test, FEK showed the highest correlation with 24 hUK-actual during low or high dose potassium chloride infusion (r=0.831, p<0.001 or r=0.764, p<0.001).
","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan, China. Electronic address: lijia0876@126.com.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan, China.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.10.024']
1370,33096225,Using virtual agents to increase physical activity in young children with the virtual fitness buddy ecosystem: Study protocol for a cluster randomized trial.,"BACKGROUND
Designing and implementing a truly self-determined physical activity (PA) intervention has required excessive amounts of labor and expenses that, until recently, have made it prohibitively costly to implement in the field at scale.
METHODS
Guided by self-determination theory, and harnessing the power of consumer-grade interactive technologies, we developed the Virtual Fitness Buddy (VFB) Ecosystem. Designed to foster intrinsic motivation toward adopting PA as a lifestyle change in 6-10-year-old children, the Ecosystem features a mixed-reality kiosk which houses a personalized virtual pet for each user. Each time a child visits the kiosk, the pet (a mid-sized dog) automatically detects its owner based on the data from a child's Fitbit, assists the child in setting daily PA goals and provides tailored feedback on the child's PA progress. The pet alerts parents in real-time by sending text messages and relaying the parents' response to the child, so that parents and children can remain connected about the child's PA progress even when they are physically apart. We aim to implement the kiosk in 12 after-school sites, plus use 12 additional sites as controls, where children can still set and view progress toward their PA goals without access to a virtual pet.
CONCLUSION
The VFB Ecosystem represents a new generation of technology-mediated health interventions for children to promote sustainable PA lifestyle changes. Because the VFB Ecosystem is a cost- and labor-effective solution that integrates consumer-grade technology with low barriers for continued use, it has the potential for rapid diffusion and widespread public health impact.",2020,"Each time a child visits the kiosk, the pet (a mid-sized dog) automatically detects its owner based on the data from a child's Fitbit, assists the child in setting daily PA goals and provides tailored feedback on the child's PA progress.","['young children with the virtual fitness buddy ecosystem', '6-10-year-old children']",['physical activity (PA) intervention'],['physical activity'],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0162358', 'cui_str': 'Ecologic Systems'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0209068,"Each time a child visits the kiosk, the pet (a mid-sized dog) automatically detects its owner based on the data from a child's Fitbit, assists the child in setting daily PA goals and provides tailored feedback on the child's PA progress.","[{'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Hahn', 'Affiliation': 'Department of Communication, University at Buffalo, State University of New York, United States. Electronic address: Lhahn2@buffalo.edu.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Schmidt', 'Affiliation': 'College of Education, University of Georgia, United States.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Rathbun', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of Georgia, United States.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Johnsen', 'Affiliation': 'College of Engineering, University of Georgia, United States.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Annesi', 'Affiliation': 'YMCA of Metro Atlanta, United States; School of Health Professions, University of Alabama at Birmingham, United States.'}, {'ForeName': 'Sun Joo Grace', 'Initials': 'SJG', 'LastName': 'Ahn', 'Affiliation': 'Grady College of Journalism & Mass Communication, University of Georgia, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106181']
1371,33096517,Bilateral ultrasound-guided erector spinae plane block in patients undergoing lumbar spinal fusion: A randomized controlled trial.,"STUDY OBJECTIVE
Spinal fusion surgery is associated with severe postoperative pain. We examined whether bilateral ultrasound-guided erector spinae plane block could alleviate postoperative pain in patients undergoing lumbar spinal fusion.
DESIGN
Blinded, randomized, controlled study.
SETTING
Tertiary university hospital, operating room, postoperative recovery room and ward.
PATIENTS
Sixty patients with American Society of Anesthesiologists grade I or II scheduled for lumbar spinal fusion surgery were randomized into the erector spinae plane block group (ESPB group) and the control group in a 1:1 ratio.
INTERVENTIONS
Pre-operative ultrasound-guided bilateral erector spinae plane block was performed in the ESPB group, while sham subcutaneous infiltration was performed in the control group.
MEASUREMENTS
The primary outcome was pain intensity at rest within 12 h postoperatively using the Numeric Rating Scale (NRS). Secondary outcomes included NRS pain scores at rest and on movement, postoperative opioid consumption and proportions of patients requiring opioid during the first 48 h after surgery.
MAIN RESULTS
The ESPB group (n = 30) showed significantly lower pain scores at rest at 4 h after surgery (estimated mean difference - 1.6, 95% confidence interval [CI] -2.4 to -0.8, p < 0.001), at 8 h (-1.3, 95% CI -1.9 to -0.6, p < 0.001), and at 12 h (-0.7, 95% CI -1.3 to -0.1, p = 0.023). The two groups showed similar pain scores at rest at 24 h after surgery (estimated mean difference - 0.2, 95% CI -0.8 to 0.5) and 48 h (-0.3, 95% CI -0.8 to 0.2). The ESPB group also showed significantly lower pain score on movement at 4 h after surgery (-1.5, 95% CI -2.5 to -0.6). The ESPB group showed a significantly smaller proportion of patients requiring sufentanil within 12 h after surgery (p = 0.020), and the group consumed significantly less sufentanil during that period (p = 0.042).
CONCLUSIONS
Bilateral ultrasound-guided erector spinae plane block improves postoperative analgesia in patients undergoing lumbar spinal fusion.",2020,"MAIN RESULTS
The ESPB group (n = 30) showed significantly lower pain scores at rest at 4 h after surgery (estimated mean difference - 1.6, 95% confidence interval [CI] -2.4 to -0.8, p < 0.001), at 8 h (-1.3, 95% CI -1.9 to -0.6, p < 0.001), and at 12 h (-0.7, 95% CI -1.3 to -0.1, p = 0.023).","['Sixty patients with American Society of Anesthesiologists grade I or II scheduled for lumbar spinal fusion surgery', 'patients undergoing lumbar spinal fusion', 'Tertiary university hospital, operating room, postoperative recovery room and ward']","['sufentanil', 'bilateral ultrasound-guided erector spinae plane block', 'Pre-operative ultrasound-guided bilateral erector spinae plane block', 'erector spinae plane block group (ESPB group) and the control group in a 1:1 ratio', 'ESPB', 'Bilateral ultrasound-guided erector spinae plane block']","['postoperative analgesia', 'pain intensity at rest within 12\xa0h postoperatively using the Numeric Rating Scale (NRS', 'smaller proportion of patients requiring sufentanil', 'pain score', 'pain scores', 'similar pain scores', 'NRS pain scores at rest and on movement, postoperative opioid consumption and proportions of patients requiring opioid during the first 48\xa0h after surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",60.0,0.356452,"MAIN RESULTS
The ESPB group (n = 30) showed significantly lower pain scores at rest at 4 h after surgery (estimated mean difference - 1.6, 95% confidence interval [CI] -2.4 to -0.8, p < 0.001), at 8 h (-1.3, 95% CI -1.9 to -0.6, p < 0.001), and at 12 h (-0.7, 95% CI -1.3 to -0.1, p = 0.023).","[{'ForeName': 'Qingfen', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yaqing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ren', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xizhe', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China. Electronic address: yifeng_65@163.com.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110090']
1372,33097384,Diabetes status modifies the efficacy of home-based kidney care for Zuni Indians in a randomized controlled trial.,"BACKGROUND
Home-Based Kidney Care (HBKC) is a pragmatic treatment approach that addresses patient preferences and cultural barriers to healthcare. We previously reported the results of a clinical trial of HBKC vs. usual care in a cohort of Zuni Indians in New Mexico. This study investigated the potential for differential efficacy of HBKC vs. usual care according to type 2 diabetes (T2DM) status.
METHODS
We analyzed the data from all individuals who participated in a randomized clinical trial that compared HBKC to usual care among patients with CKD, and assessed whether the effect of the HBKC intervention affected the subset of patients with T2DM differently than those individuals without T2DM. We used linear regression models to estimate the effect of HBKC on improvement in Patient Activation Measure (PAM) total scores within the groups of participants defined by T2DM status, and to compare the effects between these two groups. We used generalized estimating equations (GEE) to account for household clustering.
RESULTS
The original study enrolled 63 participants into the HBKC group, and 62 into the usual care. Ninety-eight of these individuals completed the 12-month intervention, 50 in the HBKC group and 48 in the usual care group. The present study compared the intervention effect in the 56 participants with T2DM (24 participants in the HBKC group and 32 in usual care) to the intervention effect in the 42 participants without T2DM (26 participants in the HBKC group and 16 in usual care). Those with T2DM who received the HBKC intervention experienced an average increase in PAM total scores of 16.0 points (95% Confidence Interval: 8.8-23.1) more than those with T2DM who were in the usual care group. For those without T2DM, the intervention had essentially no effect, with those who received the HBKC intervention having an average PAM total scores that was 1.4 points (95% C.I.: -12.4 to 9.6) lower than those who received usual care. There was a significantly different HBKC treatment effect by T2DM status (p = 0.02).
CONCLUSION
This secondary analysis suggests that the effectiveness of this HBKC intervention on increasing patient activation is most notable among those CKD patients who also have T2DM.",2020,Those with T2DM who received the HBKC intervention experienced an average increase in PAM total scores of 16.0 points (95% Confidence Interval: 8.8-23.1) more than those with T2DM who were in the usual care group.,"['Ninety-eight of these individuals completed the 12-month intervention, 50 in the HBKC group and 48 in the usual care group', '63 participants into the HBKC group, and 62 into the usual care', 'CKD patients who also have T2DM', '56 participants with T2DM (24 participants in the HBKC group and 32 in usual care) to the intervention effect in the 42 participants without T2DM (26 participants in the HBKC group and 16 in usual care']","['HBKC intervention', 'HBKC vs. usual care', 'HBKC', 'home-based kidney care', 'Home-Based Kidney Care (HBKC']","['average PAM total scores', 'Patient Activation Measure (PAM) total scores', 'patient activation', 'PAM total scores']","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}]",63.0,0.035233,Those with T2DM who received the HBKC intervention experienced an average increase in PAM total scores of 16.0 points (95% Confidence Interval: 8.8-23.1) more than those with T2DM who were in the usual care group.,"[{'ForeName': 'V Shane', 'Initials': 'VS', 'LastName': 'Pankratz', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA.'}, {'ForeName': 'E Eunice', 'Initials': 'EE', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Fares', 'Initials': 'F', 'LastName': 'Qeadan', 'Affiliation': 'Division of Public Health, Department of Family and Preventative Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Donica', 'Initials': 'D', 'LastName': 'Ghahate', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Bobelu', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Nelson', 'Affiliation': 'Chronic Kidney Disease Section, Phoenix Epidemiology and Clinical Research Branch, NIDDK, NIH, Phoenix, AZ, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Faber', 'Affiliation': 'Indian Health Service, Zuni Comprehensive Care Center, NM, USA.'}, {'ForeName': 'Vallabh O', 'Initials': 'VO', 'LastName': 'Shah', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA. Electronic address: vshah@salud.unm.edu.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107753']
1373,33098382,The Effect of N-Acetyl-Cysteine on NRF2 Antioxidant Gene Expression in Asthenoteratozoospermia Men: A Clinical Trial Study.,"Background
One of the important factor associated with male infertility is high production of reactive oxygen species (ROS). The main function of Nuclear factor erythroid 2-related factor 2 ( NRF2 ) is to activate the cellular antioxidant response by inducing the transcription of a wide array of genes that can combat the harmful effects of factors such as oxidative stress. The purpose of this study was to evaluate the effect of N-acetyl-L-cysteine (NAC), as an antioxidant drug, on NRF2 Gene Expression in Asthenoteratozoospermia Men.
Materials and Methods
In this randomized, blinded clinical trial study, included 50 infertile men with asthenoteratozoospermia, who received NAC (600 mg, three times daily). Sperm parameters analyzed according to the world health organization (WHO; 2010). Sperm DNA fragmentation, relative NRF2 expression, and seminal plasma level of antioxidant enzymes were measured by TUNEL assay, reverse transcription polymerase chain reaction (RT-PCR) and ELISA test, respectively.
Results
After NAC treatment, findings showed a significant increase in sperm concentration and motility compared to pre-treatment status, whereas the percentage of abnormal morphology and DNA fragmentation was significantly decreased (P<0.05). A significant improvement in expression of NRF2 gene and antioxidant enzyme levels were observed compared to pre-treatment by NAC (P<0.05). Significant correlations were observed between NRF2 mRNA expression level, specific sperm parameters and level of antioxidant enzymes (P<0.05).
Conclusion
The results demonstrated that NAC oral supplementation protected against oxidative stress by enhancing NRF2 expression. This could improve semen parameters quality parameters in asthenoteratozoospermia men (Registration number: IRCT20170830035998N4).",2020,A significant improvement in expression of NRF2 gene and antioxidant enzyme levels were observed compared to pre-treatment by NAC (P<0.05).,"['Asthenoteratozoospermia Men', '50 infertile men with asthenoteratozoospermia, who received']","['N-Acetyl-Cysteine', 'NAC', 'N-acetyl-L-cysteine (NAC']","['expression of NRF2 gene and antioxidant enzyme levels', 'oxidative stress', 'NRF2 mRNA expression level, specific sperm parameters and level of antioxidant enzymes', 'Antioxidant Gene Expression', 'Sperm DNA fragmentation, relative NRF2 expression, and seminal plasma level of antioxidant enzymes', 'sperm concentration and motility', 'percentage of abnormal morphology and DNA fragmentation']","[{'cui': 'C0403823', 'cui_str': 'Asthenospermia'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1565078', 'cui_str': 'NFE2L2 protein, human'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014440', 'cui_str': 'Enzyme measurement'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0242499', 'cui_str': 'Seminal plasma'}, {'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",50.0,0.128508,A significant improvement in expression of NRF2 gene and antioxidant enzyme levels were observed compared to pre-treatment by NAC (P<0.05).,"[{'ForeName': 'Rahil', 'Initials': 'R', 'LastName': 'Jannatifar', 'Affiliation': 'Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Parivar', 'Affiliation': 'Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Hayati Roodbari', 'Affiliation': 'Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Nasr-Esfahani', 'Affiliation': 'Department of Reproductive Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran. Electronic Address: mh.nasr-esfahani@royaninstitute.org.'}]",International journal of fertility & sterility,['10.22074/ijfs.2020.44411']
1374,33099015,"Intervention to promote physical activation and improve sleep and response feeding in infants for preventing obesity early in life, the baby-act trial: Rationale and design.","Infant obesity is increasing in the US, particularly among Hispanics. Rapid weight gain during infancy increases the risk of obesity later in life and could be prevented through multi-modal interventions addressing multiple risk factors through population-level programs.
OBJECTIVES
1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care.
METHODS
The lifestyle intervention focuses on age-appropriate infant physical activation, healthy sleep and sedentary patterns, and response feeding, by improving parenting skills delivered through a combination of technology (web-platform and text messages) and phone counseling. It is being tested among caregivers of infant participants of the Puerto Rico WIC program through a cluster-randomized controlled trial in 14 WIC clinics in San Juan starting in pregnancy until the infant is 12 months of age. The main outcome is infant rate of weight gain at 12 months; secondary outcomes include objectively measured hours of infant movement, sedentary behaviors and sleep, diet quality score and response feeding behaviors. We are also recording fees, time and personnel involved in the intervention development, maintenance and dissemination.
CONCLUSIONS
If successful, the intervention could be incorporated as a 'best practice' through WIC policy as a means to strengthen obesity prevention efforts to improve minority health and eliminate health disparities among Hispanics and possibly other at-risk groups beyond the childhood period. Clinicaltrials.gov registration: NCT03517891.",2020,"OBJECTIVES
1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care.
",['caregivers of infant participants of the Puerto Rico WIC program through a cluster-randomized controlled trial in 14 WIC clinics in San Juan starting in pregnancy until the infant is 12\u202fmonths of age'],"['healthy sleep and sedentary patterns, and response feeding, by improving parenting skills delivered through a combination of technology (web-platform and text messages) and phone counseling']","['infant rate of weight gain at 12\u202fmonths; secondary outcomes include objectively measured hours of infant movement, sedentary behaviors and sleep, diet quality score and response feeding behaviors', 'Rapid weight gain', 'healthy weight gain and specific behaviors (physical activity, sleep, diet']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C4277516', 'cui_str': 'Special Supplemental Nutrition Program for Women, Infants, and Children (U.S.)'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",14.0,0.0627379,"OBJECTIVES
1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Campos', 'Affiliation': 'Dental and Craniofacial Genomics Core, Endocrinology Section School of Medicine, University of Puerto Rico, San Juan 00936-5067, Puerto Rico. Electronic address: maribel.campos@upr.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pomeroy', 'Affiliation': 'Clinical Research Center, Marshfield Clinic Research Institute, Marshfield Clinic Health System, Marshfield, WI, USA. Electronic address: pomeroyj@marshfieldclinic.org.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Mays', 'Affiliation': 'Biomedical Informatics Core, Puerto Rico Clinical and Translational Research Consortium, San Juan, Puerto Rico. Electronic address: mary.mays@upr.edu.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lopez', 'Affiliation': 'Sports and Leisure Management program and Adapted Physical Education program, School of Education, Metropolitan University, San Juan Puerto Rico. Electronic address: lopeza1@suagm.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, Miami USA. Electronic address: cristina.palacios@fiu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106185']
1375,33099503,"Correction: Intensive Care Weaning (iCareWean) protocol on weaning from mechanical ventilation: a single-blinded multicentre randomised control trial comparing an open-loop decision support system and routine care, in the general intensive care unit.",,2020,,[],"['Intensive Care Weaning (iCareWean) protocol', 'Correction']",[],[],"[{'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",[],,0.132807,,[],BMJ open,['10.1136/bmjopen-2020-042145corr1']
1376,33099502,"Effects of infrapatellar fat pad preservation versus resection on clinical outcomes after total knee arthroplasty in patients with knee osteoarthritis (IPAKA): study protocol for a multicentre, randomised, controlled clinical trial.","INTRODUCTION
The infrapatellar fat pad (IPFP) is commonly resected during total knee arthroplasty (TKA) for better exposure. However, our previous studies have suggested that IPFP size was protective against, while IPFP signal intensity alteration was detrimental on knee symptoms and structural abnormalities. We hypothesise that an IPFP with normal qualities, rather than abnormal qualities, should be preserved during TKA. The aim of this study is to compare, over a 1-year period, the postoperative clinical outcomes of IPFP preservation versus resection after TKA in patients with normal or abnormal IPFP signal intensity alteration on MRI.
METHODS AND ANALYSIS
Three hundred and sixty people with end-stage knee osteoarthritis and on the waiting list for TKA will be recruited and identified as normal IPFP quality (signal intensity alteration score ≤1) or abnormal IPFP quality (signal intensity alteration score ≥2). Patients in each hospital will then be randomly allocated to IPFP resection group or preservation group. The primary outcomes are the summed score of self-reported Knee Injury and Osteoarthritis Outcome Score (KOOS), KOOS subscales assessing function in daily activities and function in sport and recreation. Secondary endpoints will be included: KOOS subscales (pain, symptoms and quality of life), Knee Society Score, 100 mm Visual Analogue Scale (VAS) Pain, timed up-and-go test, patellar tendon shortening, 100 mm VAS self-reported efficacy of reduced pain and increased quality of life, and Insall-Salvati index assessed on plain X-ray. Adverse events will be recorded. Intention-to-treat analyses will be used.
ETHICS AND DISSEMINATION
The study is approved by the local Medical Ethics Committee (Zhujiang Hospital Ethics Committee, reference number 2017-GJGBK-001) and will be conducted according to the principle of the Declaration of Helsinki (64th, 2013) and the Good Clinical Practice standard, and in compliance with the Medical Research Involving Human Subjects Act . Data will be published in peer-reviewed journals and presented at conferences, both nationally and internationally.
TRIAL REGISTRATION NUMBER
This trial was registered at Clinicaltrial.gov website on 19 October 2018 with identify number NCT03763448.",2020,The infrapatellar fat pad (IPFP) is commonly resected during total knee arthroplasty (TKA) for better exposure.,"['patients with normal or abnormal IPFP signal intensity alteration on MRI', 'patients with knee osteoarthritis (IPAKA', 'Three hundred and sixty people with end-stage knee osteoarthritis and on the waiting list for TKA']","['IPFP preservation versus resection after TKA', 'infrapatellar fat pad preservation versus resection', 'IPFP resection group or preservation group']","['normal IPFP quality (signal intensity alteration score ≤1) or abnormal IPFP quality (signal intensity alteration score ≥2', 'Adverse events', 'KOOS subscales (pain, symptoms and quality of life), Knee Society Score, 100\u2009mm Visual Analogue Scale (VAS) Pain, timed up-and-go test, patellar tendon shortening, 100\u2009mm VAS self-reported efficacy of reduced pain and increased quality of life, and Insall-Salvati index assessed on plain X-ray', 'summed score of self-reported Knee Injury and Osteoarthritis Outcome Score (KOOS), KOOS subscales assessing function in daily activities and function in sport and recreation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0224706', 'cui_str': 'Structure of infrapatellar fat pad'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0224706', 'cui_str': 'Structure of infrapatellar fat pad'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0224706', 'cui_str': 'Structure of infrapatellar fat pad'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}]",360.0,0.202602,The infrapatellar fat pad (IPFP) is commonly resected during total knee arthroplasty (TKA) for better exposure.,"[{'ForeName': 'Zhaohua', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Weiyu', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Department of Orthopaedics, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Jianhao', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Arthritis Clinical and Research Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Zongsheng', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Department of Orthopaedics, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Xifu', 'Initials': 'X', 'LastName': 'Shang', 'Affiliation': 'Department of Orthopaedic Surgery, Anhui Provincial Hospital, Hefei, China.'}, {'ForeName': 'Xisheng', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Science, Beijing, China.'}, {'ForeName': 'Zhengang', 'Initials': 'Z', 'LastName': 'Zha', 'Affiliation': 'Institute of Orthopaedic Diseases and Center for Joint Surgery and Sports Medicine, The First Affiliated Hospital, Jinan University, Guangzhou, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Orthopaedics, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Guanghua', 'Initials': 'G', 'LastName': 'Lei', 'Affiliation': 'Department of Orthopaedics, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute, Sydney, New South Wales, Australia.'}, {'ForeName': 'Changhai', 'Initials': 'C', 'LastName': 'Ding', 'Affiliation': 'Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, China Changhai.Ding@utas.edu.au.'}]",BMJ open,['10.1136/bmjopen-2020-043088']
1377,33103931,"The Safety of Medications used to Treat Peripheral Neuropathic Pain, Part 2 (Opioids, Cannabinoids and Other Drugs): review of Double-Blind, Placebo-Controlled, Randomized Clinical Trials.","INTRODUCTION
Peripheral neuropathic pain is a disabling condition for patients and a challenge for physicians. Although many drugs have been assessed in scientific studies, few have demonstrated clear clinical efficacy against neuropathic pain. Moreover, the paucity of data regarding their safety raises the question of the benefit-risk ratio when used in patients experiencing peripheral neuropathies.
AREAS COVERED
We conducted a review of double-blind, placebo-controlled, randomized clinical trials to assess the safety of medications used to treat peripheral neuropathic pain. This second review was focused on opioids, cannabinoids, and other medications. The aim was to provide an overview of the treatment-emergent adverse events (TEAEs) (≥10%) and the serious adverse effects described in clinical trials.
EXPERT OPINION
Opioids and cannabinoids had significantly more TEAEs than placebos. Locally administered analgesics, such as capsaicin, lidocaine, botulinum toxin A seemed to have the most acceptable safety with only local adverse effects. The results for NMDA antagonists were inconclusive since no safety report was available. Less than half of the studies included presented a good description of TEAEs that included a statistical comparison versus a placebo group. Major methodological improvements must be made to ameliorate the assessment of medication safety in future clinical trials.",2020,"Locally administered analgesics, such as capsaicin, lidocaine, botulinum toxin A seemed to have the most acceptable safety with only local adverse effects.",['patients experiencing peripheral neuropathies'],"['placebo', 'capsaicin, lidocaine, botulinum toxin']",['adverse effects'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.438243,"Locally administered analgesics, such as capsaicin, lidocaine, botulinum toxin A seemed to have the most acceptable safety with only local adverse effects.","[{'ForeName': 'Mélissa', 'Initials': 'M', 'LastName': 'Cuménal', 'Affiliation': 'Université Clermont Auvergne, INSERM U1107, NEURO-DOL , Clermont-Ferrand, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Selvy', 'Affiliation': 'Université Clermont Auvergne,CHU Clermont-Ferrand, INSERM U1107, NEURO-DOL , Clermont-Ferrand, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Kerckhove', 'Affiliation': 'Université Clermont Auvergne, CHU Clermont-Ferrand, INSERM U1107 NEURO-DOL, Institut Analgesia , Clermont-Ferrand, France.'}, {'ForeName': 'Célian', 'Initials': 'C', 'LastName': 'Bertin', 'Affiliation': 'Université Clermont Auvergne, CHU Clermont-Ferrand, INSERM U1107 NEURO-DOL, Institut Analgesia , Clermont-Ferrand, France.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Morez', 'Affiliation': 'Université Clermont Auvergne, INSERM U1107, NEURO-DOL , Clermont-Ferrand, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Courteix', 'Affiliation': 'Université Clermont Auvergne, INSERM U1107, NEURO-DOL , Clermont-Ferrand, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Busserolles', 'Affiliation': 'Université Clermont Auvergne, INSERM U1107, NEURO-DOL , Clermont-Ferrand, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Balayssac', 'Affiliation': 'Université Clermont Auvergne,CHU Clermont-Ferrand, INSERM U1107, NEURO-DOL , Clermont-Ferrand, France.'}]",Expert opinion on drug safety,['10.1080/14740338.2021.1842871']
1378,33106167,"Convalescent plasma transfusion therapy in severe COVID-19 patients- a safety, efficacy and dose response study: A structured summary of a study protocol of a phase II randomized controlled trial.","OBJECTIVES
General: To assess the safety, efficacy and dose response of convalescent plasma (CP) transfusion in severe COVID-19 patients Specific: a. To identify the appropriate effective dose of CP therapy in severe patients b. To identify the efficacy of the therapy with their end point based on clinical improvement within seven days of treatment or until discharge whichever is later and in-hospital mortality c. To assess the clinical improvement after CP transfusion in severe COVID-19 patients d. To assess the laboratory improvement after CP transfusion in severe COVID-19 patients TRIAL DESIGN: This is a multicentre, multi-arm phase II Randomised Controlled Trial.
PARTICIPANTS
Age and sex matched COVID-19 positive (by RT-PCR) severe cases will be enrolled in this trial. Severe case is defined by the World Health Organization (W.H.O) clinical case definition. The inclusion criteria are 1. Respiratory rate > 30 breaths/min; PLUS 2. Severe respiratory distress; or SpO2 ≤ 88% on room air or PaO2/FiO2≤ 300 mm of Hg, PLUS 3. Radiological (X-ray or CT scan) evidence of bilateral lung infiltrate, AND OR 4. Systolic BP < 90 mm of Hg or diastolic BP <60 mm of Hg. AND/OR 5. Criteria 1 to 4 AND or patient in ventilator support Patients' below18 years, pregnant and lactating women, previous history of allergic reaction to plasma, patients who have already received plasma from a different source will be excluded. Patients will be enrolled at Bangabandhu Sheikh Mujib Medical University (BSMMU) hospital, Dhaka medical college hospital (DMCH) and Mugda medical college hospital (MuMCH). Apheretic plasma will be collected at the transfusion medicine department of SHNIBPS hospital, ELISA antibody titre will be done at BSMMU and CMBT and neutralizing antibody titre will be checked in collaboration with the University of Oxford. Patients who have recovered from COVID-19 will be recruited as donors of CP. The recovery criteria are normality of body temperature for more than 3 days, resolution of respiratory symptoms, two consecutively negative results of sputum SARS-CoV-2 by RT-PCR assay (at least 24 hours apart) 22 to 35 days of post onset period, and neutralizing antibody titre ≥ 1:160.
INTERVENTION AND COMPARATOR
This RCT consists of three arms, a. standard care, b. standard care and 200 ml CP and c. standard care and 400 ml CP. Patients will receive plasma as a single transfusion. Intervention arms will be compared to the standard care arm.
MAIN OUTCOMES
The primary outcome will be time to clinical improvement within seven days of treatment or until discharge whichever is later and in-hospital mortality. The secondary outcome would be improvement of laboratory parameters after therapy (neutrophil, lymphocyte ratio, CRP, serum ferritin, SGPT, SGOT, serum creatinine and radiology), length of hospital stay, length of ICU stay, reduction in proportion of deaths, requirement of ventilator and duration of oxygen and ventilator support.
RANDOMISATION
Randomization will be done by someone not associated with the care or assessment of the patients by means of a computer generated random number table using an allocation ratio of 1:1:1.
BLINDING (MASKING)
This is an open level study; neither the physician nor the patients will be blinded. However, the primary and secondary outcome (oxygen saturations, PaO2/FiO2, BP, day specific laboratory tests) will be recorded using an objective automated method; the study staff will not be able to influence the recording of these data.
NUMBER TO BE RANDOMISED (SAMPLE SIZE)
No similar study has been performed previously. Therefore no data are available that could be used to generate a sample size calculation. This phase II study is required to provide some initial data on efficacy and safety that will allow design of a larger study. The trial will recruit 60 participants (20 in each arm).
TRIAL STATUS
Protocol version 1.4 dated May 5, 2020 and amended version 1.5, dated June 16, 2020. First case was recruited on May 27, 2020. By August 10, 2020, the trial had recruited one-third (21 out of 60) of the participants. The recruitment is expected to finish by October 31, 2020.
TRIAL REGISTRATION
Clinicaltrials.gov ID: NCT04403477 . Registered 26 May, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trial's website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.",2020,"The secondary outcome would be improvement of laboratory parameters after therapy (neutrophil, lymphocyte ratio, CRP, serum ferritin, SGPT, SGOT, serum creatinine and radiology), length of hospital stay, length of ICU stay, reduction in proportion of deaths, requirement of ventilator and duration of oxygen and ventilator support.
","['Age and sex matched COVID-19 positive (by RT-PCR) severe cases', 'Patients will be enrolled at Bangabandhu Sheikh Mujib Medical University (BSMMU) hospital, Dhaka medical college hospital (DMCH) and Mugda medical college hospital (MuMCH', 'severe COVID-19 patients Specific', 'First case was recruited on May 27, 2020', 'General', '60 participants (20 in each arm', 'By August 10, 2020, the trial had recruited one-third (21 out of 60) of the participants', 'pregnant and lactating women, previous history of allergic reaction to plasma, patients who have already received plasma from a different source will be excluded', 'severe COVID-19 patients d', 'Patients who have recovered from COVID-19 will be recruited as donors of CP', 'Protocol version 1.4 dated May 5, 2020 and amended version 1.5, dated June 16, 2020', 'severe patients']","['convalescent plasma (CP) transfusion', 'CP therapy']","['Respiratory rate > 30 breaths/min', 'NUMBER', 'Systolic BP', 'safety, efficacy', 'improvement of laboratory parameters after therapy (neutrophil, lymphocyte ratio, CRP, serum ferritin, SGPT, SGOT, serum creatinine and radiology), length of hospital stay, length of ICU stay, reduction in proportion of deaths, requirement of ventilator and duration of oxygen and ventilator support', 'oxygen saturations, PaO2/FiO2, BP, day specific laboratory tests', 'Severe respiratory distress', 'time to clinical improvement within seven days of treatment or until discharge whichever is later and in-hospital mortality']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0036828', 'cui_str': 'SGPT'}, {'cui': 'C0201899', 'cui_str': 'Aspartate aminotransferase measurement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",60.0,0.180842,"The secondary outcome would be improvement of laboratory parameters after therapy (neutrophil, lymphocyte ratio, CRP, serum ferritin, SGPT, SGOT, serum creatinine and radiology), length of hospital stay, length of ICU stay, reduction in proportion of deaths, requirement of ventilator and duration of oxygen and ventilator support.
","[{'ForeName': 'Fazle Rabbi', 'Initials': 'FR', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Internal Medicine, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh. rabbimedicine@bsmmu.edu.bd.'}, {'ForeName': 'Ashraful', 'Initials': 'A', 'LastName': 'Hoque', 'Affiliation': 'Department of Blood Transfusion, Sheikh Hasina National Institute of Burn and Plastic Surgery (SHNIBPS), Dhaka, Bangladesh.'}, {'ForeName': 'Forhad Uddin Hasan', 'Initials': 'FUH', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Medicine, Dhaka Medical College, Dhaka, Bangladesh.'}, {'ForeName': 'Md Ruhul', 'Initials': 'MR', 'LastName': 'Amin', 'Affiliation': 'Centre for Medical Biotechnology, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Abdur', 'Initials': 'A', 'LastName': 'Rahim', 'Affiliation': 'Kuwait Bangladesh Friendship Government Hospital, Dhaka, Bangladesh.'}, {'ForeName': 'M Mujibur', 'Initials': 'MM', 'LastName': 'Rahman', 'Affiliation': 'Department of Medicine, Dhaka Medical College, Dhaka, Bangladesh.'}, {'ForeName': 'Rubina', 'Initials': 'R', 'LastName': 'Yasmin', 'Affiliation': 'Department of Medicine, Mugda Medical College, Dhaka, Bangladesh.'}, {'ForeName': 'Md Robed', 'Initials': 'MR', 'LastName': 'Amin', 'Affiliation': 'Department of Medicine, Dhaka Medical College, Dhaka, Bangladesh.'}, {'ForeName': 'Md Titu', 'Initials': 'MT', 'LastName': 'Miah', 'Affiliation': 'Department of Medicine, Mugda Medical College, Dhaka, Bangladesh.'}, {'ForeName': 'Md Abul', 'Initials': 'MA', 'LastName': 'Kalam', 'Affiliation': 'Department of Blood Transfusion, Sheikh Hasina National Institute of Burn and Plastic Surgery (SHNIBPS), Dhaka, Bangladesh.'}, {'ForeName': 'Md Sayedur', 'Initials': 'MS', 'LastName': 'Rahman', 'Affiliation': 'Department of Internal Medicine, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh.'}]",Trials,['10.1186/s13063-020-04734-z']
1379,33106170,BCG revaccination of health workers in Brazil to improve innate immune responses against COVID-19: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES
The BCG vaccine, widely used in Brazil in new-borns, induces adjuvant protection for several diseases, including childhood virus infections. BCG activates monocytes and innate memory NK cells which are crucial for the antiviral immune response. Therefore, strategies to prevent COVID-19 in health workers (HW) should be carried out to prevent them becoming unwell so that they can continue to work during the pandemic. The hypothesis is that BCG will improve the innate immune response and prevent symptomatic infection or COVID-19 severity. The primary objective is to verify the effectiveness and safety of the BCG vaccine to prevent or reduce incidence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in the city of Goiânia (Brazil) among HW previously vaccinated with BCG and also its severity and mortality during the pandemic of the disease. Secondary objectives are to estimate the incidence of COVID-19 among these professionals and the innate immune response elicited to BCG.
TRIAL DESIGN
This a phase II trial for repositioning BCG as a preventive strategy against COVID-19. The trial is an open-label, parallel-group randomised clinical trial, comparing HW vaccinated with BCG and HW not vaccinated.
PARTICIPANTS
The trial will recruit 800 HW of Goiânia - Goiás, Brazil to reach a total of 400 HW included after comorbidities questioning and laboratorial evaluation. Eligibility criteria: Any HW presenting BCG vaccination scar with direct contact with suspected COVID-19 patients for at least 8 hours per week, whether in hospital beds, ICU, or in transportation or admission (nurses, doctors, physiotherapists, nutritionists, receptionists, etc.) who have negative IgM and IgG COVID-19 test. Participants with any of the following characteristics will be excluded: - Have had in the last fifteen days any signs or symptoms of virus infection, including COVID-19; - Have had fever in the last fifteen days; - Have been vaccinated fifteen days before the inclusion; - Have a history or confirmation of any immunosuppressive disease such as HIV, presented solid tumour in the last two years or autoimmune diseases; - Are under preventive medication with antibiotics, steroid anti-inflammatories, or chemotherapy; - Have less than 500 neutrophils per mL of blood; - Have previously been diagnosed with tuberculosis; - Are breastfeeding or pregnant; - Are younger than 18 years old; - Are participating as an investigator in this clinical trial.
INTERVENTION AND COMPARATOR
HW will be randomized into the BCG vaccinated group or the BCG unvaccinated control group. The BCG vaccinated group will receive in the right arm, intradermally, a one off dose of 0.1 mL corresponding to approximately 2 x10 5 to 8 x10 5 CFU of live, freeze-dried, attenuated BCG Moscow 361-I, Bacillus Calmette Guerin vaccine (Serum Institute of India PVT. LTD.). The unvaccinated control group will not be vaccinated. The HW allocated in both groups will be followed up at specific times points until 180 days post inclusion. The vaccinated and control groups will be compared according to COVID-19 related outcomes.
MAIN OUTCOMES
The primary outcomes are the incidence coefficient of infection by SARS-CoV-2 determined by RT-PCR of naso-oropharyngeal swab specimen or rapid lateral flow IgG and IgM test, and presence of general COVID-19 symptoms, disease severity and admission to hospital during the 180 days of follow up. The secondary outcome is the innate immune response elicited 15-20 days after vaccination.
RANDOMISATION
The vaccine vial contains approximately 10 doses. In order to optimize the vaccine use, the randomisation was performed in blocks of 20 participants using the platform randomization.com [ http://www.jerrydallal.com/random/permute.htm ]. The randomization was prepared before any HW inclusion. The results were printed and inserted in sealed envelopes that were numbered with BCG-001 to BCG-400. The printed results as well the envelopes had the same numbers. At the time of the randomisation, each participant that meets the inclusion criteria will receive a consecutive participant number [BCG-001-BCG-400]. The sealed envelope with the assigned number, blinded to the researchers, will be opened in front of the participant and the arm allocation will be known.
BLINDING (MASKING)
There is no masking for the participants or for the healthcare providers. The study will be blinded to the laboratory researchers and to those who will be evaluating the outcomes and performing the statistical analyses. In this case, only the participant identification number will be available.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
Four hundred heath workers will be randomised in two groups. Two hundred participants will be vaccinated, and 200 participants will not be vaccinated.
TRIAL STATUS
The protocol approved by the Brazilian Ethical Committee is the seventh version, number CAAE: 31783720.0.0000.5078. The trial has been recruiting since September 20 th , 2020. The clinical trial protocol was registered on August 5 th , 2020. It is estimated that recruitment will finish by March 2021.
TRIAL REGISTRATION
The protocol number was registered on August 5 th , 2020 at REBEC (Registro Brasileiro de Ensaios Clínicos). Register number: RBR-4kjqtg and WHO trial registration number UTN: U1111-1256-3892.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The primary outcomes are the incidence coefficient of infection by SARS-CoV-2 determined by RT-PCR of naso-oropharyngeal swab specimen or rapid lateral flow IgG and IgM test, and presence of general COVID-19 symptoms, disease severity and admission to hospital during the 180 days of follow up.","['Eligibility criteria: Any HW presenting BCG vaccination scar with direct contact with suspected COVID-19 patients for at least 8 hours per week, whether in hospital beds, ICU, or in transportation or admission (nurses, doctors, physiotherapists, nutritionists, receptionists, etc.) who have negative IgM and IgG COVID-19 test', 'Register number', 'Four hundred heath workers', 'Two hundred participants will be vaccinated, and 200 participants will not be vaccinated', 'severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in the city of Goiânia (Brazil) among HW previously vaccinated with', '20 participants using the platform randomization.com [ http://www.jerrydallal.com/random/permute.htm ', 'Participants with any of the following characteristics will be excluded: - Have had in the last fifteen days any signs or symptoms of virus infection, including COVID-19; - Have had fever in the last fifteen days; - Have been vaccinated fifteen days before the inclusion; - Have a history or confirmation of any immunosuppressive disease such as HIV, presented solid tumour in the last two years or autoimmune diseases; - Are under preventive medication with antibiotics, steroid anti-inflammatories, or chemotherapy; - Have less than 500 neutrophils per mL of blood; - Have previously been diagnosed with tuberculosis; - Are breastfeeding or pregnant; - Are younger than 18 years old; - Are participating as an investigator in this clinical trial', '800 HW of Goiânia - Goiás, Brazil to reach a total of 400 HW included after comorbidities questioning and laboratorial evaluation']","['BCG Moscow', 'BCG', 'BCG vaccine', 'UTN']","['incidence coefficient of infection by SARS-CoV-2 determined by RT-PCR of naso-oropharyngeal swab specimen or rapid lateral flow IgG and IgM test, and presence of general COVID-19 symptoms, disease severity and admission to hospital', 'innate immune response elicited 15-20 days after vaccination', 'innate immune responses against COVID-19']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0199804', 'cui_str': 'BCG vaccination'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0237083', 'cui_str': 'Nutritionist'}, {'cui': 'C0335245', 'cui_str': 'Receptionist (general)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0026580', 'cui_str': 'Moscow'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0074744', 'cui_str': 'sodium metabisulfite'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020969', 'cui_str': 'Innate Immunity'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",200.0,0.269915,"The primary outcomes are the incidence coefficient of infection by SARS-CoV-2 determined by RT-PCR of naso-oropharyngeal swab specimen or rapid lateral flow IgG and IgM test, and presence of general COVID-19 symptoms, disease severity and admission to hospital during the 180 days of follow up.","[{'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Junqueira-Kipnis', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil. ana_kipnis@ufg.br.'}, {'ForeName': 'Laura Raniere Borges', 'Initials': 'LRB', 'LastName': 'Dos Anjos', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Lília Cristina de Souza', 'Initials': 'LCS', 'LastName': 'Barbosa', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Adeliane Castro', 'Initials': 'AC', 'LastName': 'da Costa', 'Affiliation': 'Faculdade Estácio de Sá de Goiás - FESGO, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Kellen Christina Malheiros', 'Initials': 'KCM', 'LastName': 'Borges', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Amanda da Rocha Oliveira', 'Initials': 'ADRO', 'LastName': 'Cardoso', 'Affiliation': 'Faculty of Medicine, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Kaio Mota', 'Initials': 'KM', 'LastName': 'Ribeiro', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Sarah Brena Aparecida', 'Initials': 'SBA', 'LastName': 'Rosa', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Carine de Castro', 'Initials': 'CC', 'LastName': 'Souza', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Rogério Coutinho', 'Initials': 'RC', 'LastName': 'das Neves', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Guylherme', 'Initials': 'G', 'LastName': 'Saraiva', 'Affiliation': 'Faculty of Medicine, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Sueli Meira', 'Initials': 'SM', 'LastName': 'da Silva', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Erika Aparecida', 'Initials': 'EA', 'LastName': 'da Silveira', 'Affiliation': 'Faculty of Medicine, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Marcelo Fouad', 'Initials': 'MF', 'LastName': 'Rabahi', 'Affiliation': 'Faculty of Medicine, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Marcus Barreto', 'Initials': 'MB', 'LastName': 'Conte', 'Affiliation': 'Centro Universitário Arthur Sá Earp Neto. - UNIFASE- Petrópolis, Rio de Janeiro, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Kipnis', 'Affiliation': 'Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil.'}]",Trials,['10.1186/s13063-020-04822-0']
1380,33106171,Evaluation of the efficacy and safety of Melatonin in moderately ill patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES
We will evaluate the efficacy and safety of Melatonin, compared to the standard therapeutic regimen on clinical symptoms and serum inflammatory parameters in patients with confirmed COVID-19, who are moderately ill.
TRIAL DESIGN
This is a single-center, randomized, double-blind, placebo-controlled clinical trial with a parallel-group design conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran.
PARTICIPANTS
All patients admitted to Severe Acute Respiratory Syndrome Departments of Shahid Mohammadi Hospital, Bandar Abbas, Iran will be screened for the following criteria.
INCLUSION CRITERIA
1. Age ≥20 years 2. Confirmed SARS-CoV-2 diagnosis (positive polymerase chain reaction). 3. Moderate COVID-19 pneumonia (via computed tomography and or X-ray imaging), requiring hospitalization. 4. Hospitalized ≤48 hours. 5. Signing informed consent and willingness of the participant to accept randomization to any assigned treatment arm.
EXCLUSION CRITERIA
1. Underlying diseases, including chronic hypertension, diabetes mellitus, seizure, depression, chronic hepatitis, cirrhosis, and cholestatic liver diseases. 2. Severe and critical COVID-19 pneumonia. 3. Use of warfarin, corticosteroids, hormonal drugs, alcohol, other antiviral and investigational medicines, and illegal drugs (during the last 30 days). 4. History of known allergy to Melatonin. 5. Pregnancy and breastfeeding.
INTERVENTION AND COMPARATOR
Intervention group: The standard treatment regimen for COVID-19, according to the Iranian Ministry of Health and Medical Education's protocol, along with Melatonin capsules at a dose of 50 mg daily for a period of seven days.
CONTROL GROUP
The standard therapeutic regimen for COVID-19 along with Melatonin-like placebo capsules at a dose of one capsule daily for a period of seven days. Both Melatonin and placebo capsules were prepared at the Faculty of Pharmacy and Pharmaceutical Sciences, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
MAIN OUTCOMES
The primary outcomes are the recovery rate of clinical symptoms and oxygen saturation as well as improvement of serum inflammatory parameters, including C-reactive protein, tumor necrosis factor-alpha (TNF-ɑ), interleukin-1β (IL-1β), and IL-6 within seven days of randomization. The secondary outcomes are the time to improve clinical and paraclinical features along with the incidence of serious adverse drug reactions within seven days of randomization.
RANDOMIZATION
Included patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 10 patients). This randomization method ensures a balanced allocation between the arms during the study. A web-based system will generate random numbers for the allocation sequence and concealment of participants. Each number relates to one of the study arms.
BLINDING (MASKING)
All study participants, clinicians, nurses, research coordinators, and those analyzing the data are blinded to the group assignment.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)
A total of 60 patients randomized into two groups (30 in each group).
TRIAL STATUS
The trial protocol is Version 1.0, August 14, 2020. Recruitment began August 22, 2020, and is anticipated to be completed by November 30, 2020.
TRIAL REGISTRATION
The trial protocol has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is "" IRCT20200506047323N5 "". The registration date was 14 August 2020.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The primary outcomes are the recovery rate of clinical symptoms and oxygen saturation as well as improvement of serum inflammatory parameters, including C-reactive protein, tumor necrosis factor-alpha (TNF-ɑ), interleukin-1β (IL-1β), and IL-6 within seven days of randomization.","['Age ≥20 years 2', 'Shahid Mohammadi Hospital, Bandar Abbas, Iran', 'All patients admitted to Severe Acute Respiratory Syndrome Departments of Shahid Mohammadi Hospital, Bandar Abbas, Iran will be screened for the following criteria', '60 patients randomized into two groups (30 in each group', 'patients with confirmed COVID-19, who are moderately ill', 'moderately ill patients with COVID-19']","['Melatonin-like placebo', 'warfarin, corticosteroids, hormonal drugs, alcohol, other antiviral and investigational medicines, and illegal drugs', 'placebo', ""standard treatment regimen for COVID-19, according to the Iranian Ministry of Health and Medical Education's protocol, along with Melatonin capsules"", 'Melatonin and placebo', 'Melatonin', 'GROUP']","['recovery rate of clinical symptoms and oxygen saturation as well as improvement of serum inflammatory parameters, including C-reactive protein, tumor necrosis factor-alpha (TNF-ɑ), interleukin-1β (IL-1β), and IL-6 within seven days of randomization', 'time to improve clinical and paraclinical features along with the incidence of serious adverse drug reactions', 'efficacy and safety', 'clinical symptoms and serum inflammatory parameters', 'Severe and critical COVID-19 pneumonia']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1175175', 'cui_str': 'Severe acute respiratory syndrome'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3653892', 'cui_str': 'Other antivirals'}, {'cui': 'C0260205', 'cui_str': 'Investigative Medicine'}, {'cui': 'C0086190', 'cui_str': 'Drugs, Illegal'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",60.0,0.384965,"The primary outcomes are the recovery rate of clinical symptoms and oxygen saturation as well as improvement of serum inflammatory parameters, including C-reactive protein, tumor necrosis factor-alpha (TNF-ɑ), interleukin-1β (IL-1β), and IL-6 within seven days of randomization.","[{'ForeName': 'Ava', 'Initials': 'A', 'LastName': 'Ziaei', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Parivash', 'Initials': 'P', 'LastName': 'Davoodian', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Dadvand', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Safa', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Hassanipour', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Omidi', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Moein', 'Initials': 'M', 'LastName': 'Masjedi', 'Affiliation': 'Department of Pharmaceutics, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fahime', 'Initials': 'F', 'LastName': 'Mahmoudikia', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Rafiee', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fathalipour', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. M.fathalipour@hums.ac.ir.'}]",Trials,['10.1186/s13063-020-04737-w']
1381,33109252,"The efficacy of Siddha Medicine, Kabasura Kudineer (KSK) compared to Vitamin C & Zinc (CZ) supplementation in the management of asymptomatic COVID-19 cases: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES
The primary objectives of this study are to determine efficacy of Siddha medicine, Kabasura kudineer in reduction of SARS-CoV-2 viral load and reducing the onset of symptoms in asymptomatic COVID-19 when compared to Vitamin C and Zinc (CZ) supplementation. In addition, the trial will examine the changes in the immunological markers of the Siddha medicine against control. The secondary objectives of the trial are to evaluate the safety of the Siddha medicine and to document clinical profile of asymptomatic COVID-19 as per principles of Siddha system of Medicine.
TRIAL DESIGN
A single centre, open-label, parallel group (1:1 allocation ratio), exploratory randomized controlled trial.
PARTICIPANTS
Cases admitted at non-hospital settings designated as COVID Care Centre and managed by the State Government Stanley Medical College, Chennai, Tamil Nadu, India will be recruited. Eligible participants will be those tested positive for COVID-19 by Reverse Transcriptase Polymerase Chain reaction (RT-PCR) aged 18 to 55 years without any symptoms and co-morbidities like diabetes mellitus, hypertension and bronchial asthma. Those pregnant or lactating, with severe respiratory disease, already participating in COVID trials and with severe illness like malignancy will be excluded.
INTERVENTION AND COMPARATOR
Adopting traditional methods, decoction of Kabasura kudineer will be prepared by boiling 5g of KSK powder in 240 ml water and reduced to one-fourth (60ml) and filtered. The KSK group will receive a dose of 60ml decoction, orally in the morning and evening after food for 14 days. The control group will receive Vitamin C (60000 IU) and Zinc tablets (100mg) orally in the morning and evening respectively for 14 days.
MAIN OUTCOMES
The primary outcomes are the reduction in the SARS-CoV-2 load [as measured by cyclic threshold (CT) value of RT-PCR] from the baseline to that of seventh day of the treatment, prevention of progression of asymptomatic to symptomatic state (clinical symptoms like fever, cough and breathlessness) and changes in the immunity markers [Interleukins (IL) 6, IL10, IL2, Interferon gamma (IFNγ) and Tumor Necrosis Factor (TNF) alpha]. Clinical assessment of COVID-19 as per standard Siddha system of medicine principles and the occurrence of adverse effects will be documented as secondary outcomes.
RANDOMISATION
The assignment to the study or control group will be allocated in equal numbers through randomization using random number generation in Microsoft Excel by a statistician who is not involved in the trial. The allocation scheme will be made by an independent statistician using a sealed envelope. The participants will be allocated immediately after the eligibility assessment and informed consent procedures.
BLINDING (MASKING)
This study is unblinded. The investigators will be blinded to data analysis, which will be carried out by a statistician who is not involved in the trial.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
Sample size could not be calculated, as there is no prior trial on KSK. This trial will be a pilot trial. Hence, we intend to recruit 60 participants in total using a 1:1 allocation ratio, with 30 participants randomised into each arm.
TRIAL STATUS
Protocol version 2.0 dated 16 th May 2020. Recruitment is completed. The trial started recruitment on the 25 th May 2020. We anticipate study including data analysis will finish on November 2020. We also stated that protocol was submitted before the end of data collection TRIAL REGISTRATION: The study protocol was registered with clinical trial registry of India (CTRI) with CTRI/2020/05/025215 on 16 May 2020.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"Eligible participants will be those tested positive for COVID-19 by Reverse Transcriptase Polymerase Chain reaction (RT-PCR) aged 18 to 55 years without any symptoms and co-morbidities like diabetes mellitus, hypertension and bronchial asthma.","['Those pregnant or lactating, with severe respiratory disease, already participating in COVID trials and with severe illness like malignancy', 'asymptomatic COVID-19 cases', '60 participants in total using a 1:1 allocation ratio, with 30 participants randomised into each arm', 'Eligible participants will be those tested positive for COVID-19 by Reverse Transcriptase Polymerase Chain reaction (RT-PCR) aged 18 to 55 years without any symptoms and co-morbidities like diabetes mellitus, hypertension and bronchial asthma', 'Protocol version 2.0 dated 16 th May 2020', 'Cases admitted at non-hospital settings designated as COVID Care Centre and managed by the State Government Stanley Medical College, Chennai, Tamil Nadu, India will be recruited']","['Siddha Medicine, Kabasura Kudineer (KSK', 'Vitamin C', 'Zinc tablets', 'Vitamin C & Zinc (CZ) supplementation', '60ml decoction', 'Vitamin C and Zinc (CZ) supplementation', 'Siddha medicine, Kabasura kudineer']","['prevention of progression of asymptomatic to symptomatic state (clinical symptoms like fever, cough and breathlessness) and changes in the immunity markers [Interleukins (IL) 6, IL10, IL2, Interferon gamma (IFNγ) and Tumor Necrosis Factor (TNF) alpha', 'reduction in the SARS-CoV-2 load [as measured by cyclic threshold (CT) value of RT-PCR']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035204', 'cui_str': 'Disorder of respiratory system'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0038191', 'cui_str': 'Government, State'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0039285', 'cui_str': 'Tamil language'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0259995', 'cui_str': 'Siddha Medicine'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}]",,0.425945,"Eligible participants will be those tested positive for COVID-19 by Reverse Transcriptase Polymerase Chain reaction (RT-PCR) aged 18 to 55 years without any symptoms and co-morbidities like diabetes mellitus, hypertension and bronchial asthma.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Natarajan', 'Affiliation': 'Siddha Central Research Institute, Chennai, India. drnatarajan78@gmail.com.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anbarasi', 'Affiliation': 'Siddha Central Research Institute, Chennai, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sathiyarajeswaran', 'Affiliation': 'Siddha Central Research Institute, Chennai, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Manickam', 'Affiliation': 'ICMR-National Institute of Epidemiology, Chennai, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Geetha', 'Affiliation': 'Government Stanley Medical College, Chennai, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kathiravan', 'Affiliation': 'Government Stanley Medical College, Chennai, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Prathiba', 'Affiliation': 'Government Stanley Medical College, Chennai, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pitchiahkumar', 'Affiliation': 'State Licensing Authority (Indian Medicine), Chennai, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Parthiban', 'Affiliation': 'Department of Indian Medicine and Homeopathy, Government of Tamil Nadu, Chennai, India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kanakavalli', 'Affiliation': 'Central Council for Research in Siddha, Ministry of AYUSH, Chennai, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Balaji', 'Affiliation': 'Government Stanley Medical College, Chennai, India.'}]",Trials,['10.1186/s13063-020-04823-z']
1382,33119047,Effect of Vitamin D and ω-3 Fatty Acid Supplementation on Risk of Age-Related Macular Degeneration: An Ancillary Study of the VITAL Randomized Clinical Trial.,"Importance
Observational studies suggest that higher intake or blood levels of vitamin D and marine ω-3 fatty acids may be associated with lower risks of age-related macular degeneration (AMD). However, evidence from randomized trials is limited.
Objective
To evaluate whether daily supplementation with vitamin D3, marine ω-3 fatty acids, or both prevents the development or progression of AMD.
Design, Setting, and Participants
This was a prespecified ancillary study of the Vitamin D and Omega-3 Trial (VITAL), a nationwide, placebo-controlled, 2 × 2 factorial design randomized clinical trial of supplementation with vitamin D and marine ω-3 fatty acids for the primary prevention of cancer and cardiovascular disease. Participants included 25 871 men and women in the US. Randomization was from November 2011 to March 2014, and study pill-taking ended as planned on December 31, 2017.
Interventions
Vitamin D3 (cholecalciferol), 2000 IU per day, and marine ω-3 fatty acids, 1 g per day.
Main Outcomes and Measures
The primary end point was total AMD events, a composite of incident cases of AMD plus cases of progression to advanced AMD among participants with AMD at baseline, based on self-report confirmed by medical record review. Analyses were conducted using the intention-to-treat population.
Results
In total, 25 871 participants with a mean (SD) age of 67.1 (7.0) years were included in the trial. Of them, 50.6% were women, 71.3% were self-declared non-Hispanic White participants, and 20.2% were Black participants. During a median (range) of 5.3 (3.8-6.1) years of treatment and follow-up, 324 participants experienced an AMD event (285 incident AMD and 39 progression to advanced AMD). For vitamin D3, there were 163 events in the treated group and 161 in the placebo group (hazard ratio [HR], 1.02; 95% CI, 0.82-1.27). For ω-3 fatty acids, there were 157 events in the treated group and 167 in the placebo group (HR, 0.94; 95% CI, 0.76-1.17). In analyses of individual components for the primary end point, HRs comparing vitamin D3 groups were 1.09 (95% CI, 0.86-1.37) for incident AMD and 0.63 (95% CI, 0.33-1.21) for AMD progression. For ω-3 fatty acids, HRs were 0.93 (95% CI, 0.73-1.17) for incident AMD and 1.05 (95% CI, 0.56-1.97) for AMD progression.
Conclusion and Relevance
Neither vitamin D3 nor marine ω-3 fatty acid supplementation had a significant overall effect on AMD incidence or progression.
Trial Registration
ClinicalTrials.gov Identifier: NCT01782352.",2020,"Conclusion and Relevance
Neither vitamin D3 nor marine ω-3 fatty acid supplementation had a significant overall effect on AMD incidence or progression.
","['Participants included 25\u202f871 men and women in the US', 'Of them, 50.6% were women, 71.3% were self-declared non-Hispanic White participants, and 20.2% were Black participants', 'In total, 25\u202f871 participants with a mean (SD) age of 67.1 (7.0) years were included in the trial']","['supplementation with vitamin D and marine ω-3 fatty acids', 'placebo', 'Vitamin D and Omega-3 Trial (VITAL', 'Vitamin D and ω-3 Fatty Acid Supplementation', 'Vitamin D3 (cholecalciferol', 'vitamin D3, marine ω-3 fatty acids']","['total AMD events, a composite of incident cases of AMD plus cases of progression to advanced AMD', 'Risk of Age-Related Macular Degeneration', 'AMD incidence or progression']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0024437', 'cui_str': 'Degenerative disorder of macula'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",25871.0,0.55341,"Conclusion and Relevance
Neither vitamin D3 nor marine ω-3 fatty acid supplementation had a significant overall effect on AMD incidence or progression.
","[{'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Christen', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Chasman', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': 'Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Chunying', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Margarette', 'Initials': 'M', 'LastName': 'Haubourg', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Schaumberg', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.4409']
1383,33119048,Effect of Vocimagene Amiretrorepvec in Combination With Flucytosine vs Standard of Care on Survival Following Tumor Resection in Patients With Recurrent High-Grade Glioma: A Randomized Clinical Trial.,"Importance
New treatments are needed to improve the prognosis of patients with recurrent high-grade glioma.
Objective
To compare overall survival for patients receiving tumor resection followed by vocimagene amiretrorepvec (Toca 511) with flucytosine (Toca FC) vs standard of care (SOC).
Design, Setting, and Participants
A randomized, open-label phase 2/3 trial (TOCA 5) in 58 centers in the US, Canada, Israel, and South Korea, comparing posttumor resection treatment with Toca 511 followed by Toca FC vs a defined single choice of approved (SOC) therapies was conducted from November 30, 2015, to December 20, 2019. Patients received tumor resection for first or second recurrence of glioblastoma or anaplastic astrocytoma.
Interventions
Patients were randomized 1:1 to receive Toca 511/FC (n = 201) or SOC control (n = 202). For the Toca 511/FC group, patients received Toca 511 injected into the resection cavity wall at the time of surgery, followed by cycles of oral Toca FC 6 weeks after surgery. For the SOC control group, patients received investigators' choice of single therapy: lomustine, temozolomide, or bevacizumab.
Main Outcomes and Measures
The primary outcome was overall survival (OS) in time from randomization date to death due to any cause. Secondary outcomes reported in this study included safety, durable response rate (DRR), duration of DRR, durable clinical benefit rate, OS and DRR by IDH1 variant status, and 12-month OS.
Results
All 403 randomized patients (median [SD] age: 56 [11.46] years; 62.5% [252] men) were included in the efficacy analysis, and 400 patients were included in the safety analysis (3 patients on the SOC group did not receive resection). Final analysis included 271 deaths (141 deaths in the Toca 511/FC group and 130 deaths in the SOC control group). The median follow-up was 22.8 months. The median OS was 11.10 months for the Toca 511/FC group and 12.22 months for the control group (hazard ratio, 1.06; 95% CI 0.83, 1.35; P = .62). The secondary end points did not demonstrate statistically significant differences. The rates of adverse events were similar in the Toca 511/FC group and the SOC control group.
Conclusions and Relevance
Among patients who underwent tumor resection for first or second recurrence of glioblastoma or anaplastic astrocytoma, administration of Toca 511 and Toca FC, compared with SOC, did not improve overall survival or other efficacy end points.
Trial Registration
ClinicalTrials.gov Identifier: NCT02414165.",2020,"The rates of adverse events were similar in the Toca 511/FC group and the SOC control group.
","['271 deaths (141 deaths in the Toca 511/FC group and 130 deaths in the SOC control group', 'patients who underwent tumor resection for first or second recurrence of glioblastoma or anaplastic astrocytoma', 'With Recurrent High-Grade Glioma', 'Patients', 'patients with recurrent high-grade glioma', '58 centers in the US, Canada, Israel, and South Korea, comparing posttumor resection treatment with Toca 511 followed by Toca FC vs a defined single choice of approved (SOC) therapies was conducted from November 30, 2015, to December 20, 2019', 'All 403 randomized patients (median [SD] age: 56 [11.46] years; 62.5% [252] men) were included in the efficacy analysis, and 400 patients were included in the safety analysis (3 patients on the SOC group did not receive resection', 'patients receiving tumor resection followed by vocimagene amiretrorepvec (Toca 511) with']","['Flucytosine vs Standard of Care', 'flucytosine (Toca FC) vs standard of care (SOC', 'SOC control', 'single therapy: lomustine, temozolomide, or bevacizumab', 'Toca 511/FC']","['overall survival (OS', 'median OS', 'safety, durable response rate (DRR), duration of DRR, durable clinical benefit rate, OS and DRR by', 'rates of adverse events', 'overall survival']","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0334579', 'cui_str': 'Astrocytoma, anaplastic'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4722370', 'cui_str': 'Toca 511'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0016278', 'cui_str': 'Flucytosine'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",403.0,0.0964429,"The rates of adverse events were similar in the Toca 511/FC group and the SOC control group.
","[{'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Cloughesy', 'Affiliation': 'University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Petrecca', 'Affiliation': 'Montreal Neurological Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Walbert', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Butowski', 'Affiliation': 'University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Salacz', 'Affiliation': 'University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Perry', 'Affiliation': 'Sunnybrook Research Institute, Sunnybrook Hospital, Toronto, Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Damek', 'Affiliation': 'University of Colorado, Aurora, Colorado.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bota', 'Affiliation': 'University of California, Irvine, Irvine, California.'}, {'ForeName': 'Chetan', 'Initials': 'C', 'LastName': 'Bettegowda', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jay-Jiguang', 'Initials': 'JJ', 'LastName': 'Zhu', 'Affiliation': 'University of Texas Health Science Center, Houston, Texas.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Iwamoto', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Placantonakis', 'Affiliation': 'New York University Langone Medical Center, New York, New York.'}, {'ForeName': 'Lyndon', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Elder', 'Affiliation': 'Ohio State University, Columbus, Ohio.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kaptain', 'Affiliation': 'John Theurer Cancer Center, Hackensack University, Hackensack, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cachia', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Moshel', 'Affiliation': 'Overlook Medical Center, Summit, New Jersey.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Brem', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Piccioni', 'Affiliation': 'University of California San Diego, San Diego, California.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Landolfi', 'Affiliation': 'JFK Medical Center, Edison, New Jersey.'}, {'ForeName': 'Clark C', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Gruber', 'Affiliation': 'Formerly Tocagen Inc, San Diego, California.'}, {'ForeName': 'Aliz', 'Initials': 'A', 'LastName': 'Rao', 'Affiliation': 'Formerly Tocagen Inc, San Diego, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hogan', 'Affiliation': 'Formerly Tocagen Inc, San Diego, California.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Accomando', 'Affiliation': 'Formerly Tocagen Inc, San Diego, California.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Ostertag', 'Affiliation': 'Formerly Tocagen Inc, San Diego, California.'}, {'ForeName': 'Tiffany T', 'Initials': 'TT', 'LastName': 'Montellano', 'Affiliation': 'Formerly Tocagen Inc, San Diego, California.'}, {'ForeName': 'Thian', 'Initials': 'T', 'LastName': 'Kheoh', 'Affiliation': 'Formerly Tocagen Inc, San Diego, California.'}, {'ForeName': 'Fairooz', 'Initials': 'F', 'LastName': 'Kabbinavar', 'Affiliation': 'Formerly Tocagen Inc, San Diego, California.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Vogelbaum', 'Affiliation': 'Cleveland Clinic Foundation, Moffitt Cancer Center, Tampa, Florida.'}]",JAMA oncology,['10.1001/jamaoncol.2020.3161']
1384,33121501,Determinants of response to inhaled extrafine triple therapy in asthma: analyses of TRIMARAN and TRIGGER.,"BACKGROUND
A number of single-inhaler triple therapies are being developed for asthma, including the extrafine formulation of beclometasone dipropionate (BDP), formoterol fumarate (FF), and glycopyrronium (G). Given asthma is a heterogenous disease, we investigated whether the clinical response to the addition of the long-acting muscarinic antagonist component within inhaled triple therapy was impacted by a range of clinical characteristics.
METHODS
These were pre-specified and post-hoc sub-group analyses of TRIMARAN and TRIGGER, which were double-blind, 52-week studies comparing medium-strength (100/6/10 µg; TRIMARAN) and high-strength (200/6/10 µg; TRIGGER) BDP/FF/G with the respective BDP/FF strengths in adults with uncontrolled asthma and a history of ≥ 1 exacerbation. Co-primary endpoints were pre-dose forced expiratory volume in 1 s (FEV 1 ) at Week 26 and the rate of moderate-to-severe exacerbations over 52 weeks. Key secondary endpoints: peak FEV 1 at Week 26 and average morning peak expiratory flow over the first 26 weeks in each study, and severe exacerbation rate over 52 weeks (pooled data).
RESULTS
Baseline clinical characteristics (pre-specified analyses) had no consistent effect on the lung function improvements with BDP/FF/G. For the exacerbation endpoints, sub-groups with higher reversibility gained greatest relative benefit from BDP/FF/G versus BDP/FF. In post-hoc analyses with patients sub-grouped by screening blood eosinophil values, in TRIMARAN the greatest relative effect of BDP/FF/G versus BDP/FF on the lung function endpoints was in the ≤ 300 cells/µL group; in TRIGGER, eosinophil levels did not markedly influence the relative efficacy of BDP/FF/G versus BDP/FF. Eosinophil levels did not influence relative efficacy on moderate-to-severe or severe exacerbations.
CONCLUSION
Overall, the relative efficacy of extrafine BDP/FF/G versus BDP/FF was not influenced by a range of clinical characteristics. However, some patient sub-groups gained additional benefit from BDP/FF/G for certain endpoints. In particular, for exacerbations the relative efficacy of BDP/FF/G was greater in more reversible patients. Trial registration ClinicalTrials.gov: TRIMARAN, NCT02676076 (registered February 8, 2016, https://clinicaltrials.gov/ct2/show/NCT02676076?term=NCT02676076&draw=2&rank=1 ,); TRIGGER, NCT02676089 (registered February 8, 2016, https://clinicaltrials.gov/ct2/show/NCT02676089?term=NCT02676089&draw=2&rank=1 ).",2020,"For the exacerbation endpoints, sub-groups with higher reversibility gained greatest relative benefit from BDP/FF/G versus BDP/FF.","['asthma', 'adults with uncontrolled asthma and a history of\u2009≥\u20091 exacerbation']","['beclometasone dipropionate (BDP), formoterol fumarate (FF), and glycopyrronium (G', 'inhaled extrafine triple therapy', 'extrafine BDP/FF/G versus BDP/FF']","['rate of moderate-to-severe exacerbations', 'severe exacerbation rate', 'screening blood eosinophil values', 'peak FEV 1 at Week 26 and average morning peak expiratory flow', 'Eosinophil levels', 'pre-dose forced expiratory volume in 1\xa0s (FEV 1 ']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0004906', 'cui_str': 'Beclomethasone dipropionate'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}]",,0.568295,"For the exacerbation endpoints, sub-groups with higher reversibility gained greatest relative benefit from BDP/FF/G versus BDP/FF.","[{'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK. dsingh@meu.org.uk.'}, {'ForeName': 'Johann Christian', 'Initials': 'JC', 'LastName': 'Virchow', 'Affiliation': 'Zentrum Für Innere Medizin, Abteilung Für Pneumologie, Universitätsmedizin Rostock, Rostock, Germany.'}, {'ForeName': 'Giorgio Walter', 'Initials': 'GW', 'LastName': 'Canonica', 'Affiliation': 'Center of Personalized Medicine: Asthma and Allergy, Humanitas University and Research Hospital IRCCS, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vele', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Kots', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Georges', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Papi', 'Affiliation': 'Respiratory Medicine Unit, University of Ferrara, University Hospital S.Anna, Ferrara, Italy.'}]",Respiratory research,['10.1186/s12931-020-01558-y']
1385,33121536,Implementing a multilevel intervention to accelerate colorectal cancer screening and follow-up in federally qualified health centers using a stepped wedge design: a study protocol.,"BACKGROUND
Screening for colorectal cancer (CRC) not only detects disease early when treatment is more effective but also prevents cancer by finding and removing precancerous polyps. Because many of our nation's most disadvantaged and vulnerable individuals obtain health care at federally qualified health centers, these centers play a significant role in increasing CRC screening among the most vulnerable populations. Furthermore, the full benefits of cancer screenings must include timely and appropriate follow-up of abnormal results. Thus, the purpose of this study is to implement a multilevel intervention to increase rates of CRC screening, follow-up, and referral-to-care in federally qualified health centers, as well as simultaneously to observe and to gather information on the implementation process to improve the adoption, implementation, and sustainment of the intervention. The multilevel intervention will target three different levels of influences: organization, provider, and individual. It will have multiple components, including provider and staff education, provider reminder, provider assessment and feedback, patient reminder, and patient navigation.
METHODS
This study is a multilevel, three-phase, stepped wedge cluster randomized trial with four clusters of clinics from four different FQHC systems. In the first phase, there will be a 3-month waiting period during which no intervention components will be implemented. After the 3-month waiting period, we will randomize two clusters to cross from the control to the intervention and the remaining two clusters to follow 3 months later. All clusters will stay at the same phase for 9 months, followed by a 3-month transition period, and then cross over to the next phase.
DISCUSSION
There is a pressing need to reduce disparities in CRC outcomes, especially among racial/ethnic minority populations and among populations who live in poverty. Single-level interventions are often insufficient to lead to sustainable changes. Multilevel interventions, which target two or more levels of changes, are needed to address multilevel contextual influences simultaneously. Multilevel interventions with multiple components will affect not only the desired outcomes but also each other. How to take advantage of multilevel interventions and how to implement such interventions and evaluate their effectiveness are the ultimate goals of this study.
TRIAL REGISTRATION
This protocol is registered at clinicaltrials.gov ( NCT04514341 ) on 14 August 2020.",2020,"It will have multiple components, including provider and staff education, provider reminder, provider assessment and feedback, patient reminder, and patient navigation.
","['four clusters of clinics from four different FQHC systems', '14 August 2020']",['multilevel intervention'],[],"[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0284914,"It will have multiple components, including provider and staff education, provider reminder, provider assessment and feedback, patient reminder, and patient navigation.
","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Center for Asian Health Equity, University of Chicago, 5841\u2009S. Maryland Ave, MC1140, Chicago, IL, 60637, USA.'}, {'ForeName': 'Blasé', 'Initials': 'B', 'LastName': 'Polite', 'Affiliation': 'University of Chicago Medicine Hematology and Oncology, 5841\u2009S Maryland Ave, Chicago, IL, 60637, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Public Health Sciences, University of Chicago Biological Sciences, 5841\u2009S. Maryland Ave, Rm W-254, MC2000, Chicago, IL, 60637, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Liebovitz', 'Affiliation': 'Division of General Internal Medicine & Geriatrics, Feinberg School of Medicine, Northwestern University, 750\u2009N. Lake Shore Dr., 10th Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Fornessa', 'Initials': 'F', 'LastName': 'Randal', 'Affiliation': 'Center for Asian Health Equity, University of Chicago, 5841\u2009S. Maryland Ave, MC1140, Chicago, IL, 60637, USA.'}, {'ForeName': 'Manasi', 'Initials': 'M', 'LastName': 'Jayaprakash', 'Affiliation': 'Center for Asian Health Equity, University of Chicago, 5841\u2009S. Maryland Ave, MC1140, Chicago, IL, 60637, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Quinn', 'Affiliation': 'Department of Internal Medicine, Section of General Internal Medicine, University of Chicago, 5841\u2009S Maryland Ave, Chicago, IL, 60637, USA.'}, {'ForeName': 'Sang Mee', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Chicago Biological Sciences, 5841\u2009S. Maryland Ave, Rm W-254, MC2000, Chicago, IL, 60637, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lam', 'Affiliation': 'Center for Asian Health Equity, University of Chicago, 5841\u2009S. Maryland Ave, MC1140, Chicago, IL, 60637, USA. hvallina@medicine.bsd.uchicago.edu.'}]",Implementation science : IS,['10.1186/s13012-020-01045-4']
1386,33122421,Angiographic control versus ischaemia-driven management of patients undergoing percutaneous revascularisation of the unprotected left main coronary artery with second-generation drug-eluting stents: rationale and design of the PULSE trial.,"BACKGROUND
The role of planned angiographic control (PAC) over a conservative management driven by symptoms and ischaemia following percutaneous coronary intervention (PCI) of the unprotected left main (ULM) with second-generation drug-eluting stents remains controversial. PAC may timely detect intrastent restenosis, but it is still unclear if this translated into improved prognosis.
METHODS AND ANALYSIS
PULSE is a prospective, multicentre, open-label, randomised controlled trial. Consecutive patients treated with PCI on ULM will be included, and after the index revascularisation patients will be randomised to PAC strategy performed with CT coronary after 6 months versus a conservative symptoms and ischaemia-driven follow-up management. Follow-up will be for at least 18 months from randomisation. Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome. Secondary outcomes will include any unplanned target lesion revascularisation (TLR) and TLR driven by PAC. Safety endpoints embrace worsening of renal failure and bleeding events. A sample size of 550 patients (275 per group) is required to have a 80% chance of detecting, as significant at the 5% level, a 7.5% relative reduction in the primary outcome.
TRIAL REGISTRATION NUMBER
NCT04144881.",2020,"Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome.","['Consecutive patients treated with', 'patients undergoing percutaneous revascularisation of the unprotected left main coronary artery with second-generation drug-eluting stents']","['CT coronary', 'PCI', 'planned angiographic control (PAC', 'Angiographic control versus ischaemia-driven management']","['Major adverse cardiovascular events', 'renal failure and bleeding events', 'death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis', 'unplanned target lesion revascularisation (TLR) and TLR driven by PAC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",550.0,0.16451,"Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome.","[{'ForeName': 'Ovidio', 'Initials': 'O', 'LastName': 'De Filippo', 'Affiliation': 'Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy ovidio.defilippo@gmail.com.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bianco', 'Affiliation': 'Division of Cardiology, San Luigi Gonzaga University Hospital, Orbassano, Italy, Orbassano, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Tebaldi', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Iannaccone', 'Affiliation': 'Department of Cardiology, San Giovanni Bosco Hospital, ASL Città di Torino, Turin, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Gaido', 'Affiliation': 'Division of Cardiology, Maria Vittoria Hospital, Turin, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Guiducci', 'Affiliation': 'Cardiology Unit, Azienda USL-IRCCS Reggio Emilia, S. Maria Nuova Hospital, Reggio Emilia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Santarelli', 'Affiliation': 'Division of Cardiology, Department of Cardiovascular Diseases, AUSL Romagna, Degli Infermi Hospital, Rimini, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Zaccaro', 'Affiliation': 'Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Depaoli', 'Affiliation': 'University Radiodiagnostic Unit, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Vaudano', 'Affiliation': 'Radiology Unit, San Giovanni Bosco Hospital, Turin, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Quadri', 'Affiliation': 'Cardiology Unit, Infermi Hospital, Rivoli, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gagnor', 'Affiliation': 'Division of Cardiology, Maria Vittoria Hospital, Turin, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Boccuzzi', 'Affiliation': 'Department of Cardiology, San Giovanni Bosco Hospital, ASL Città di Torino, Turin, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Solitro', 'Affiliation': 'Radiology, San Luigi Gonzaga Hospital, University of Turin, Orbassano, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Cortese', 'Affiliation': 'Radiology, Maria Vittoria Hospital, Turin, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Guarnaccia', 'Affiliation': 'University Radiodiagnostic Unit, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Tore', 'Affiliation': 'University Radiodiagnostic Unit, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Veltri', 'Affiliation': 'Radiology Unit, San Luigi Gonzaga University Hospital, Orbassano, Italy, Turin, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Franchin', 'Affiliation': 'Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Angelini', 'Affiliation': 'Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Garbo', 'Affiliation': 'Department of Cardiology, San Giovanni Bosco Hospital, ASL Città di Torino, Turin, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Giammaria', 'Affiliation': 'Division of Cardiology, Maria Vittoria Hospital, Turin, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Varbella', 'Affiliation': 'Cardiology Unit, Infermi Hospital, Rivoli, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Marchisio', 'Affiliation': 'Radiology Unit, Infermi Hospital, Rivoli, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fonio', 'Affiliation': 'University Radiodiagnostic Unit, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Gaetano Maria', 'Initials': 'GM', 'LastName': 'De Ferrari', 'Affiliation': 'Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Cerrato', 'Affiliation': 'Interventional Cardiology Unit, San Luigi Gonzaga University Hospital, Orbassano and Rivoli Infermi Hospital, RIvoli, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': 'Division of Cardiology, Azienda Ospedaliero-Universitaria di Ferrara, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': ""D'Ascenzo"", 'Affiliation': 'Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}]",Open heart,['10.1136/openhrt-2020-001253']
1387,33125362,Effect of Whole-Brain and Intensity-Modulated Radiotherapy on Serum Levels of miR-21 and Prognosis for Lung Cancer Metastatic to the Brain.,"BACKGROUND The goal of the present study was to explore the influence of whole-brain radiotherapy (WBRT) and intensity-modulated radiotherapy (IMRT) on serum levels of miR-21 and prognosis for lung cancer that has metastasized to the brain. MATERIAL AND METHODS Two hundred patients with lung cancer metastatic to the brain were randomized, half to the control group and half to the observation group. The observation group received WBRT and reduced-field IMRT (WBRT+RF-IMRT) and the control group received conventional-field IMRT (CF-IMRT). The total effective rate after treatment was determined. Serum levels of miR-21 were measured before and after radiotherapy with reverse transcriptase-polymerase chain reaction. In addition, tumor marker levels were measured with enzyme-linked immunosorbent assay. The relationship between miR-21 levels and tumor marker levels was assessed with a Pearson correlation coefficient test. Five-year survival was estimated with Kaplan-Meier curves. RESULTS The total effective rate was higher in the observation group (86%) than in the control group (69%). Lower levels of miR-21 and tumor markers were seen in the observation group. Moreover, miR-21 levels were positively correlated with levels of tumor necrosis factor-a, neuron-specific enolase, SCC-Ag, and carcinoembryonic antigen. Low levels of miR-21 were associated with longer overall survival in patients with lung cancer metastatic to the brain. CONCLUSIONS WBRT+RF-IMRT is superior to CF-IMRT for lung cancer metastatic to the brain. MiR-21 may be a marker for prediction of the efficacy of radiotherapy in this disease setting.",2020,The total effective rate was higher in the observation group (86%) than in the control group (69%).,"['patients with lung cancer metastatic to the brain', 'Two hundred patients with lung cancer metastatic to the brain', 'Lung Cancer Metastatic to the Brain']","['conventional-field IMRT (CF-IMRT', 'WBRT+RF-IMRT', 'Whole-Brain and Intensity-Modulated Radiotherapy', 'whole-brain radiotherapy (WBRT) and intensity-modulated radiotherapy (IMRT', 'radiotherapy', 'WBRT and reduced-field IMRT (WBRT+RF-IMRT']","['Serum levels of miR-21', 'total effective rate', 'miR-21 levels', 'levels of tumor necrosis factor-a, neuron-specific enolase, SCC-Ag, and carcinoembryonic antigen', 'tumor marker levels', 'Lower levels of miR-21 and tumor markers', 'miR-21 levels and tumor marker levels', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0075091', 'cui_str': 'Squamous cell carcinoma antigen'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0474700', 'cui_str': 'Tumor marker measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",200.0,0.0544242,The total effective rate was higher in the observation group (86%) than in the control group (69%).,"[{'ForeName': 'Zhensheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Oncology, Jinan Hospital of Integrated Traditional Chinese and Western Medicine, Jinan, Shandong, China (mainland).'}, {'ForeName': 'Qiurong', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Lung Disease Division, Jinan Hospital of Integrated Traditional Chinese and Western Medicine, Jinan, Shandong, China (mainland).'}, {'ForeName': 'Mingjuan', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ""Department of Cardiology, Jinan People's Hospital, Jinan, Shandong, China (mainland).""}, {'ForeName': 'Zhongliang', 'Initials': 'Z', 'LastName': 'Qi', 'Affiliation': 'Department of Oncology, Jinan Hospital of Integrated Traditional Chinese and Western Medicine, Jinan, Shandong, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.924640']
1388,33125390,"Caregiver experience and perceived acceptability of a novel near point-of-care early infant HIV diagnostic test among caregivers enrolled in the PMTCT program, Myanmar: A qualitative study.","BACKGROUND
The majority of HIV infection among children occurs through mother-to-child transmission. HIV exposed infants are recommended to have virological testing at birth or 4-6 weeks of age but challenges with centralized laboratory-based testing in Myanmar result in low testing rates and delays in result communication and treatment initiation. Decentralized point-of-care (POC) testing when integrated in prevention of mother-to-child transmission of HIV (PMTCT) services, can be an alternative to increase coverage of early infant diagnosis (EID) and timely engagement in HIV treatment and care.
AIM
This paper aims to explore experiences of caregivers of HIV-exposed infants enrolled in the PMTCT program in Myanmar and the perceived acceptability of point-of-care EID testing compared to conventional centralised laboratory-based testing.
METHODS
This is a sub-study of the cluster randomised controlled stepped-wedge trial (Trial registration number: ACTRN12616000734460) that assessed the impact of near POC EID testing using Xpert HIV-1 Qual assay in four public hospitals in Myanmar. Caregivers of infants who were enrolled in the intervention phase of the main study, had been tested with both Xpert and standard of care tests and had received the results were eligible for this qualitative study. Semi-structured interviews were conducted with 23 caregivers. Interviews were audio recorded, transcribed verbatim and translated into English. Thematic data analysis was undertaken using NVivo 12 Software (QSR International).
RESULTS
The majority of caregivers were satisfied with the quality of care provided by PMTCT services. However, they encountered social and financial access barriers to attend the PMTCT clinic regularly. Mothers had concerns about community stigma from the disclosure of their HIV status and the potential consequences for their infants. While medical care at the PMTCT clinics was free, caregivers sometimes experienced financial difficulties associated with out-of-pocket expenses for childbirth and transportation. Some caregivers had to choose not to attend work (impacting their income) or the adult antiretroviral clinic in order to attend the paediatric PMTCT clinic appointment. The acceptability of the Xpert testing process was high among the caregiver participants and more than half received the Xpert result on the same day as testing. Short turnaround time of the near POC EID testing enabled the caregivers to find out their infants' HIV status quicker, thereby shortening the stressful waiting time for results.
CONCLUSION
Our study identified important access challenges facing caregivers of HIV exposed infants and high acceptability of near POC EID testing. Improving the retention rate in the PMTCT and EID programs necessitates careful attention of program managers and policy makers to these challenges, and POC EID represents a potential solution.",2020,"Improving the retention rate in the PMTCT and EID programs necessitates careful attention of program managers and policy makers to these challenges, and POC EID represents a potential solution.","['caregivers of HIV-exposed infants enrolled in the PMTCT program in Myanmar', 'caregivers enrolled in the PMTCT program, Myanmar', 'four public hospitals in Myanmar', 'Caregivers of infants who were enrolled in the intervention phase of the main study, had been tested with both Xpert and standard of care tests and had received the results were eligible for this qualitative study']","['Decentralized point-of-care (POC', 'conventional centralised laboratory-based testing']","['stressful waiting time', 'retention rate']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0949415', 'cui_str': 'Qualitative Research'}]","[{'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.0683998,"Improving the retention rate in the PMTCT and EID programs necessitates careful attention of program managers and policy makers to these challenges, and POC EID represents a potential solution.","[{'ForeName': 'Win Lei', 'Initials': 'WL', 'LastName': 'Yee', 'Affiliation': 'Burnet Institute, Yangon, Myanmar.'}, {'ForeName': 'Kyu Kyu', 'Initials': 'KK', 'LastName': 'Than', 'Affiliation': 'Burnet Institute, Yangon, Myanmar.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Mohamed', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Hla', 'Initials': 'H', 'LastName': 'Htay', 'Affiliation': 'Burnet Institute, Yangon, Myanmar.'}, {'ForeName': 'Htay Htay', 'Initials': 'HH', 'LastName': 'Tin', 'Affiliation': 'National Health Laboratory, Ministry of Health and Sports, Yangon, Myanmar.'}, {'ForeName': 'Win', 'Initials': 'W', 'LastName': 'Thein', 'Affiliation': 'National Health Laboratory, Ministry of Health and Sports, Yangon, Myanmar.'}, {'ForeName': 'Latt Latt', 'Initials': 'LL', 'LastName': 'Kyaw', 'Affiliation': 'National Health Laboratory, Ministry of Health and Sports, Yangon, Myanmar.'}, {'ForeName': 'Win Win', 'Initials': 'WW', 'LastName': 'Yee', 'Affiliation': 'National Health Laboratory, Ministry of Health and Sports, Yangon, Myanmar.'}, {'ForeName': 'Moe Myat', 'Initials': 'MM', 'LastName': 'Aye', 'Affiliation': 'National Health Laboratory, Ministry of Health and Sports, Yangon, Myanmar.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Badman', 'Affiliation': 'The Kirby Institute for Infection and Immunity in Society, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Vallely', 'Affiliation': 'The Kirby Institute for Infection and Immunity in Society, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Luchters', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kelly-Hanku', 'Affiliation': 'The Kirby Institute for Infection and Immunity in Society, UNSW Sydney, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0241245']
1389,33125399,Effects of music therapy as an adjunct to chest physiotherapy in children with cystic fibrosis: A randomized controlled trial.,"Airway clearance therapy (ACT) is considered an important approach to improve airway clearance in children with cystic fibrosis (CF). Daily ACT administration requires substantial commitments of time and energy that complicate ACT and reduce its benefits. It is crucial to establish ACT as a positive routine. Music therapy (MT) is an aspect of integrative strategies to ameliorate the psycho-emotional consequences of chronic diseases, and a MT intervention could help children with CF between the ages of 2 and 17 develop a positive response. The aim of this randomized controlled trial was to evaluate the effects of specifically composed and recorded instrumental music as an adjunct to ACT. We compared the use of specifically composed music (Treated Group, TG), music that the patient liked (Placebo Group, PG), and no music (Control Group, CG) during the usual ACT routine in children with CF aged from 2 to 17. The primary outcomes, i.e., enjoyment and perception of time, were evaluated via validated questionnaires. The secondary outcome, i.e., efficiency, was evaluated in terms of avoided healthcare resources. Enjoyment increased after the use of the specifically composed music (children +0.9 units/parents +1.7 units; p<0.05) compared to enjoyment with no music (0 units) and familiar music (+0.5 units). Perception of time was 11.1 min (±3.9) less than the actual time in the TG (p<0.05), 3.9 min (±4.2) more than the actual time in the PG and unchanged in the CG. The potential cost saving related to respiratory exacerbations was €6,704.87, while the cost increased to €33,524.35 in the CG and to €13,409.74 in the PG. In conclusion, the specifically composed, played and compiled instrumental recorded music is an effective adjunct to ACT to establish a positive response and is an efficient option in terms of avoided costs. Trial registered as ISRCTN11161411. ISRCTN registry (www.isrctn.com).",2020,"The potential cost saving related to respiratory exacerbations was €6,704.87, while the cost increased to €33,524.35 in the CG and to €13,409.74 in the PG.","['children with cystic fibrosis', 'children with CF aged from 2 to 17', 'children with cystic fibrosis (CF']","['music therapy', 'Airway clearance therapy (ACT', 'Music therapy (MT', 'specifically composed music (Treated Group, TG), music that the patient liked (Placebo Group, PG), and no music (Control Group, CG']","['Perception of time', 'enjoyment and perception of time', 'Enjoyment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]",,0.0895695,"The potential cost saving related to respiratory exacerbations was €6,704.87, while the cost increased to €33,524.35 in the CG and to €13,409.74 in the PG.","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Montero-Ruiz', 'Affiliation': 'Departamento de Farmacología y Pediatría, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga, Facultad de Medicina, Málaga, Spain.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Fuentes', 'Affiliation': 'Departamento de Farmacología y Pediatría, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga, Facultad de Medicina, Málaga, Spain.'}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Pérez Ruiz', 'Affiliation': 'Departamento de Farmacología y Pediatría, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga, Facultad de Medicina, Málaga, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'García-Agua Soler', 'Affiliation': 'Departamento de Farmacología y Pediatría, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga, Facultad de Medicina, Málaga, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Rius-Diaz', 'Affiliation': 'Departamento de Medicina Preventiva y Salud Pública, Universidad de Málaga, Facultad de Medicina, Málaga, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Caro Aguilera', 'Affiliation': 'Departamento de Farmacología y Pediatría, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga, Facultad de Medicina, Málaga, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Pérez Frías', 'Affiliation': 'Departamento de Farmacología y Pediatría, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga, Facultad de Medicina, Málaga, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Martín-Montañez', 'Affiliation': 'Departamento de Farmacología y Pediatría, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga, Facultad de Medicina, Málaga, Spain.'}]",PloS one,['10.1371/journal.pone.0241334']
1390,33125902,Postoperative hemorrhage following coblation tonsillectomy with and without suture: A randomized study in Chinese adults.,"PURPOSE
Coblation tonsillectomy (TE) increases gradually in China. Hemorrhage is the main complication after tonsillectomy. The conclusions of the studies about suture after tonsillectomy are conflicting. To compare the post-tonsillectomy hemorrhage (PTH) rates in patients who underwent coblation with vs. without suture.
MATERIALS AND METHODS
This was a randomized controlled study of adult patients who underwent coblation TE at our hospital between 01/2017 and 08/2019. The patients were randomized to TE with or without suture. The primary endpoint was the secondary PTH. The secondary endpoints included the primary PTH, grade of PTH, and incidence of PTH within 4 weeks post-TE.
RESULTS
There were no differences between the two groups regarding sex, age, disease course, and BMI (all P > 0.05). The occurrence of secondary PTH was lower in the suture group compared with the non-suture group (2.8% vs. 7.7%, P = 0.016). Compared with non-suture group, the incidence of PTH within 4 weeks (2.8% vs. 10.6%, P = 0.009) and the PTH degree (P = 0.02) were all significantly lower in the suture group.
CONCLUSION
Intraoperative suture reduces the secondary PTH in adult patients who underwent coblation tonsillectomy. The incidence of PTH within 4 weeks, PTH degree and pain might all improved for intraoperative suture.",2020,"The occurrence of secondary PTH was lower in the suture group compared with the non-suture group (2.8% vs. 7.7%, P = 0.016).","['Chinese adults', 'patients who underwent coblation with vs. without suture', 'adult patients who underwent coblation TE at our hospital between 01/2017 and 08/2019', 'adult patients who underwent coblation tonsillectomy']","['Coblation tonsillectomy (TE', 'TE with or without suture', 'coblation tonsillectomy with and without suture', 'Intraoperative suture']","['primary PTH, grade of PTH, and incidence of PTH within 4\xa0weeks post-TE', 'Postoperative hemorrhage', 'post-tonsillectomy hemorrhage (PTH) rates', 'incidence of PTH within 4\xa0weeks, PTH degree and pain', 'occurrence of secondary PTH', 'PTH degree', 'secondary PTH', 'incidence of PTH']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1960390', 'cui_str': 'Plasma mediated ablation tonsillectomy'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C1960390', 'cui_str': 'Plasma mediated ablation tonsillectomy'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C1279603', 'cui_str': 'Primary post tonsillectomy hemorrhage'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1279604', 'cui_str': 'Secondary post tonsillectomy hemorrhage'}]",,0.0848415,"The occurrence of secondary PTH was lower in the suture group compared with the non-suture group (2.8% vs. 7.7%, P = 0.016).","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Department of Otolaryngology, ShenZhen People's Hospital, Shenzhen, Guangdong, China. Electronic address: 13923457897@139.com.""}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Otolaryngology, 8th Medical Center, PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yanlu', 'Initials': 'Y', 'LastName': 'Lyu', 'Affiliation': ""Department of Otolaryngology, ShenZhen People's Hospital, Shenzhen, Guangdong, China.""}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102760']
1391,33125944,Avelumab-cetuximab-radiotherapy versus standards of care in locally advanced squamous-cell carcinoma of the head and neck: The safety phase of a randomised phase III trial GORTEC 2017-01 (REACH).,"BACKGROUND
Based on the hypothesis of synergistic effect of avelumab with cetuximab and radiotherapy, this new combination is tested in a randomised trial against two well-established standard of care (SOC) in locally advanced squamous-cell carcinoma of the head and neck (LA-SCCHN).
METHODS
This phase III trial comprises two cohorts of patients deemed fit to receive cisplatin (100 mg/m 2 Q3W) (cohort 1) or unfit to cisplatin (cohort 2). The SOC was Intensity Modulated Radiation Therapy (IMRT) with cisplatin in cohort 1 (arm A) and with weekly cetuximab in cohort 2 (arm D). In both cohorts, experimental arms (arms B and C) were IMRT with cetuximab and avelumab (10 mg/kg day 7 and every 2 weeks) followed by avelumab every two weeks for 12 months. A safety phase was planned among the first 41 patients in experimental arms by monitoring grade ≥IV adverse events (AEs) with an unacceptable rate of 35%.
RESULTS
Between September 2017 and August 2018, 82 patients with LA-SCCHN were randomised including 41 patients in experimental arms. All patients of experimental arms except one (arm C) received entire radiotherapy as planned. Most common grade ≥III AEs were mucositis, radio-dermatitis, and dysphagia. Grade ≥IV AEs occurred in 5/41 (12%) patients, all in arm C (no grade V). This rate was acceptable according to the hypotheses of the safety phase. In the SOC arms, grade ≥IV AEs occurred in 3/21 patients (14%) in arm A and 2/20 (10%) in arm D. One grade V haemorrhage occurred in arm A.
CONCLUSION
The avelumab-cetuximab-RT combination was tolerable for patients with LA-SCCHN, and the approval was given for continuing the trial without modification. CLINICALTRIAL.GOV: NCT02999087.",2020,"In the SOC arms, grade ≥IV AEs occurred in 3/21 patients (14%) in arm A and 2/20 (10%) in arm D. One grade V haemorrhage occurred in arm A.
CONCLUSION
","['locally advanced squamous-cell carcinoma of the head and neck (LA-SCCHN', 'Between September 2017 and August 2018, 82 patients with LA-SCCHN', 'locally advanced squamous-cell carcinoma of the head and neck']","['avelumab with cetuximab and radiotherapy', 'cisplatin', 'avelumab-cetuximab-RT combination', 'Avelumab-cetuximab-radiotherapy', 'SOC was Intensity Modulated Radiation Therapy (IMRT) with cisplatin', 'unfit to cisplatin', 'IMRT with cetuximab and avelumab', 'entire radiotherapy']","['Grade ≥IV AEs', 'mucositis, radio-dermatitis, and dysphagia', 'grade ≥IV AEs', 'grade V haemorrhage']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0439751', 'cui_str': 'Entire'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",82.0,0.0711299,"In the SOC arms, grade ≥IV AEs occurred in 3/21 patients (14%) in arm A and 2/20 (10%) in arm D. One grade V haemorrhage occurred in arm A.
CONCLUSION
","[{'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Aupérin', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Xushan', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Hopital Nord Franche-Comté de Montbéliard & CHRU de Besançon, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sire', 'Affiliation': 'Centre Hospitalier de Lorient, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Centre Guillaume le Conquérant, Le Havre, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Coutte', 'Affiliation': 'CHU, Amiens, France.'}, {'ForeName': 'Cedrik', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Miroir', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Liem', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Rolland', 'Affiliation': 'ICO Rene-Gauducheau, Nantes, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Even', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Nguyen', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saada', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Maillard', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Colin-Batailhou', 'Affiliation': 'GORTEC, Tours, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Centre Francois Baclesse, Caen, France.'}, {'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Guigay', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'CHUV Lausanne, Switzerland. Electronic address: jean.bourhis@chuv.ch.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.09.008']
1392,33126051,"More precise dosing of acenocoumarol for better control in patients aged above 80 years, a randomised controlled pilot study.","INTRODUCTION
Many elderly patients are confined to treatment with vitamin K antagonists (VKA) instead of direct oral anticoagulants (DOACs). However, quality of VKA treatment declines with age. This might be caused by the lower dose requirements with increasing age, which result in relatively large day-by-day VKA dose differences. Therefore, more precise dosing with smaller dose increments might improve quality of VKA treatment in the elderly.
METHODS
We randomised 80 elderly patients (≥80 years, using 0.5-2 mg acenocoumarol daily) to either conventional dosing with 1.0 mg acenocoumarol increments, or more precise dosing with 0.5 mg increments, to assess effect sizes and feasibility of a larger trial. We compared changes in the time in therapeutic range (TTR), INR variability and anticoagulation-related quality of life (measured with the PACT-Q) between treatment groups.
RESULTS
Overall, baseline TTR was 61.3 ± 19.2. After six study months, TTR had improved to 69.5 ± 19.7 in the precise dosing group versus 67.7 ± 21.2 in the conventional dosing group (absolute difference 3.4 (95% CI -6.7 to 13.6)). The between-groups difference in INR variability was not assessed because of baseline differences. PACT-Q convenience declined slightly with more precise dosing, compared with conventional dosing: 2.1/100 (95% CI 0.5-3.7). Satisfaction decreased equally in both groups with -6.4 ± 8.6/100. Four dosing errors occurred: three with precise and one with conventional dosing.
CONCLUSION
Although more precise dosing of acenocoumarol leads to a slightly higher TTR, this effect is too small to convey a relevant clinical benefit and could be abolished by the increased risk of medication errors.",2020,"PACT-Q convenience declined slightly with more precise dosing, compared with conventional dosing: 2.1/100 (95% CI 0.5-3.7).","['patients aged above 80\xa0years', '80 elderly patients (≥80\xa0years, using 0.5-2\xa0mg acenocoumarol daily) to either', 'Many elderly patients']","['conventional dosing with 1.0\xa0mg acenocoumarol', 'acenocoumarol', 'vitamin K antagonists (VKA']","['time in therapeutic range (TTR), INR variability and anticoagulation-related quality of life', 'Satisfaction', 'TTR', 'INR variability', 'quality of VKA treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0000956', 'cui_str': 'Acenocoumarol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0000956', 'cui_str': 'Acenocoumarol'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460097', 'cui_str': 'Within therapeutic range'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",80.0,0.0462563,"PACT-Q convenience declined slightly with more precise dosing, compared with conventional dosing: 2.1/100 (95% CI 0.5-3.7).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Piersma-Wichers', 'Affiliation': 'Department of Haematology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; Certe Thrombosis Service Groningen, Groningen, the Netherlands.'}, {'ForeName': 'J H A', 'Initials': 'JHA', 'LastName': 'van Miert', 'Affiliation': 'Department of Haematology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; Certe Thrombosis Service Groningen, Groningen, the Netherlands. Electronic address: j.h.a.van.miert@umcg.nl.'}, {'ForeName': 'N J G M', 'Initials': 'NJGM', 'LastName': 'Veeger', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Centre, Groningen, the Netherlands.'}, {'ForeName': 'H A M', 'Initials': 'HAM', 'LastName': 'Kooistra', 'Affiliation': 'Department of Haematology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Meijer', 'Affiliation': 'Department of Haematology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}]",Thrombosis research,['10.1016/j.thromres.2020.10.018']
1393,33126374,Clinical nursing pathway improves the nursing satisfaction in patients with acute cerebral hemorrhage: A randomized controlled trial protocol.,"BACKGROUND
Cerebral hemorrhage (CH) is a very common cerebrovascular disorder in clinical practice. More and more studies reported that proper nursing care could promote the rate of treatment, and improve the prognosis after treatment. Clinical nursing pathway (CNP) refers to original nursing mode with good quality, outstanding efficiency, and low treatment spending. Few articles have reported the effect of CNP in patients with acute CH. The program is in urgent need of convinced evidence to prove the reliability. Thus, we perform this randomized controlled trial protocol and hypothesize that CNP is associated with improved outcomes and nursing satisfaction, reduced adverse reactions in patients with acute CH.
METHOD
It is a single-center randomized controlled study to be conducted from October 2020 to October 2021. It was admitted via the Ethics Committee of the West China Hospital of Sichuan University (0038842/121). Eighty patients meet diagnostic standards for CH are included. The study group receives the clinical nursing path model. In the control group, patients receive the routine care before and after taking to the hospital. The main outcome contains the Barthel index score, the patient's degree of satisfaction about care, the length of hospital stay, and the risk of complications such as infection, bedsores and gastrointestinal function between the 2 groups. Six months after admission, the functional independence measure and Fugl Meyer score are recorded. All data are analyzed by the IBM SPSS Statistics, version 20 (IBM Corp., Armonk, NY edition).
RESULTS
Table 1 shows the clinical outcomes between groups.
CONCLUSION
CNP may improve the clinical outcomes for patients with acute CH and have a significant value in actual applications.
TRIAL REGISTRATION NUMBER
researchregistry6061.",2020,"The main outcome contains the Barthel index score, the patient's degree of satisfaction about care, the length of hospital stay, and the risk of complications such as infection, bedsores and gastrointestinal function between the 2 groups.","['patients with acute cerebral hemorrhage', 'Eighty patients meet diagnostic standards for CH are included', 'October 2020 to October 2021', 'patients with acute CH']",['CNP'],"['adverse reactions', 'functional independence measure and Fugl Meyer score', 'IBM SPSS Statistics, version 20 (IBM Corp., Armonk, NY edition', ""Barthel index score, the patient's degree of satisfaction about care, the length of hospital stay, and the risk of complications such as infection, bedsores and gastrointestinal function""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0238190', 'cui_str': 'Inclusion body myositis'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",80.0,0.0785752,"The main outcome contains the Barthel index score, the patient's degree of satisfaction about care, the length of hospital stay, and the risk of complications such as infection, bedsores and gastrointestinal function between the 2 groups.","[{'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Department of Neurological comprehensive ward.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': 'Department of Neurological comprehensive ward.'}, {'ForeName': 'Chaofeng', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': 'Department of Neurological comprehensive ward.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Nursing, West China Hospital of Sichuan University/West China Nursing College, Sichuan, China.'}]",Medicine,['10.1097/MD.0000000000022989']
1394,33126375,Comparison anterior minimally invasive oblique retroperitoneal approach and posterior transpedicular approach for debridement fusion in patients with lumbar vertebral osteomyelitis: A randomized controlled trial protocol.,"BACKGROUND
Pyogenic osteomyelitis of the spine usually occurs in patients over 55 years old with acute osteomyelitis. Surgical treatment and fixation can relieve pain, enhance spinal balance and nerve function, so that patients can walk as soon as possible. Different outcomes of surgical methods include anterior minimally invasive oblique retroperitoneal approach (ORA) and posterior transpedicular approach (PTA). While, there is no consensus on the best treatment for PVO. The goal of the protocol is to compare the clinical consequences between PTA and ORA for treating PVO.
METHOD
The experiment is a single-center randomized clinical research. This experiment was admitted by the Ethics Committee of the People's Hospital of Dayi County (Approval number: 1002-084). In all, 50 patients with lumbar vertebral osteomyelitis (LVO) who prepares surgical treatment will be included in the study. We contain adult patients (aged over 18 years) who accept debridement and spinal stabilization with LVO. Cases are removed if there is previous hardware placement, cases who are not confirmed by microbiology, or severe renal and liver dysfunction. The primary outcomes are intraoperative blood loss, operative time, hospital stay, primary failure and recurrence, and bone fusion. The secondary outcomes are postoperative pain score and physical recovery. SPSS Sample Power version 3.0 (IBM, Armonk, NY, USA) is used for data analysis.
RESULTS
Table 1 will show the outcomes in both groups.
CONCLUSION
This protocol may offer a reliable basis for the effectiveness of the two approaches in the treatment of PVO.
TRIAL REGISTRATION NUMBER
researchregistry6046.",2020,Different outcomes of surgical methods include anterior minimally invasive oblique retroperitoneal approach (ORA) and posterior transpedicular approach (PTA).,"['adult patients (aged over 18 years) who accept debridement and spinal stabilization with LVO', 'patients with lumbar vertebral osteomyelitis', 'patients over 55 years old with acute osteomyelitis', '50 patients with lumbar vertebral osteomyelitis (LVO) who prepares surgical treatment will be included in the study']","['surgical methods include anterior minimally invasive oblique retroperitoneal approach (ORA) and posterior transpedicular approach (PTA', 'Comparison anterior minimally invasive oblique retroperitoneal approach and posterior transpedicular approach', 'Surgical treatment and fixation']","['pain, enhance spinal balance and nerve function', 'SPSS Sample Power version 3.0 (IBM, Armonk, NY, USA', 'intraoperative blood loss, operative time, hospital stay, primary failure and recurrence, and bone fusion', 'postoperative pain score and physical recovery']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0158371', 'cui_str': 'Acute osteomyelitis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0205502', 'cui_str': 'Retroperitoneal approach'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0442371', 'cui_str': 'Transpedicular approach'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0238190', 'cui_str': 'Inclusion body myositis'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0185364', 'cui_str': 'Osteoplasty'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",50.0,0.145126,Different outcomes of surgical methods include anterior minimally invasive oblique retroperitoneal approach (ORA) and posterior transpedicular approach (PTA).,"[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopedics.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Wan', 'Affiliation': ""Department of Stomatology, The People's Hospital of Dayi County, Chengdu, Sichuan, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lv', 'Affiliation': 'Department of Orthopedics.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Orthopedics.'}, {'ForeName': 'Yangbin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics.'}]",Medicine,['10.1097/MD.0000000000022990']
1395,33126401,Exposure of Biomimetic Composite Materials to Acidic Challenges: Influence on Flexural Resistance and Elastic Modulus.,"Acidic conditions of the oral cavity, including soft drinks and cariogenic bacteria, represent a damage for restorative biomimetic composite materials. The aim of this study is to assess the influence of two different acidic challenges on the flexural strength and elastic modulus of five composites: x-tra fil (Group 1, XTF), GrandioSO x-tra (Group 2, GXT), Admira Fusion x-tra (Group 3, AFX), VisCalor bulk (Group 4, VCB), and Enamel Plus HRi (Group 5, EPH). Thirty samples for each group were randomly divided and assigned to three different treatments: storage in distilled water as the controls (subgroups 1a-5a), 3 weeks distilled water + 1 week Coca-Cola (subgroups 1b-5b), and 4 weeks Coca-Cola (subgroups 1c-5c). For each subgroup, the flexural strength and elastic modulus were measured using an Instron universal testing machine, and data were submitted to statistical analysis. Considering subgroups B, no material showed a significant difference in the flexural strength with the controls ( p > 0.05), whereas for subgroups C, only GXT and VCB showed significantly lower values ( p < 0.05). AFX reported the lowest flexural strength among the materials tested. As regards the elastic modulus, no material showed a significant variation after acidic storages when compared with the respective control ( p > 0.05). AFX and EPH reported the lowest elastic modulus compared to the other materials. All composites tested showed adequate flexural properties according to the standards, except for AFX. This biomimetic material, along with EPH, might be indicated for V class (cervical) restorations considering the lowest values of elasticity reported.",2020,"Considering subgroups B, no material showed a significant difference in the flexural strength with the controls ( p > 0.05), whereas for subgroups C, only GXT and VCB showed significantly lower values ( p < 0.05).",['Exposure of Biomimetic Composite Materials to Acidic Challenges'],"['AFX and EPH', 'AFX', 'tra fil (Group 1, XTF), GrandioSO x-tra (Group 2, GXT), Admira Fusion x-tra (Group 3, AFX), VisCalor bulk (Group 4, VCB), and Enamel Plus HRi']","['adequate flexural properties', 'lowest flexural strength', 'flexural strength', 'Flexural Resistance and Elastic Modulus', 'flexural strength and elastic modulus']","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0872312', 'cui_str': 'Bio-inspired Engineering'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0908506', 'cui_str': 'Eph Family Receptors'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C4085648', 'cui_str': 'Tagalog language'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1313391', 'cui_str': 'admira'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2350289', 'cui_str': 'Young Modulus'}]",,0.0159474,"Considering subgroups B, no material showed a significant difference in the flexural strength with the controls ( p > 0.05), whereas for subgroups C, only GXT and VCB showed significantly lower values ( p < 0.05).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Scribante', 'Affiliation': 'Department of Clinical, Surgical, Diagnostic and Paediatric Sciences-Section of Dentistry, University of Pavia, Piazzale Golgi 2, 27100 Pavia, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': 'Department of Clinical, Surgical, Diagnostic and Paediatric Sciences-Section of Dentistry, University of Pavia, Piazzale Golgi 2, 27100 Pavia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Scarantino', 'Affiliation': 'Department of Clinical, Surgical, Diagnostic and Paediatric Sciences-Section of Dentistry, University of Pavia, Piazzale Golgi 2, 27100 Pavia, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Dagna', 'Affiliation': 'Department of Clinical, Surgical, Diagnostic and Paediatric Sciences-Section of Dentistry, University of Pavia, Piazzale Golgi 2, 27100 Pavia, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Poggio', 'Affiliation': 'Department of Clinical, Surgical, Diagnostic and Paediatric Sciences-Section of Dentistry, University of Pavia, Piazzale Golgi 2, 27100 Pavia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colombo', 'Affiliation': 'Department of Clinical, Surgical, Diagnostic and Paediatric Sciences-Section of Dentistry, University of Pavia, Piazzale Golgi 2, 27100 Pavia, Italy.'}]","Biomimetics (Basel, Switzerland)",['10.3390/biomimetics5040056']
1396,33126534,"The Metabolic Effects of Cynara Supplementation in Overweight and Obese Class I Subjects with Newly Detected Impaired Fasting Glycemia: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial.","Impaired fasting glucose (IFG) is a condition that precedes diabetes and increases the risk of developing it. Studies support the hypoglycemic effect of Cynara scolymus (Cs) extracts due to the content of chlorogenic acid, which is a potent inhibitor of glucose 6-phosphate translocase and of dicaffeoylquinic acid derivatives that modulate the activity of alpha-glucosidase. Given this background, we investigated whether a new highly standardized Cs extract could improve glycemic control, insulin sensitivity and other metabolic parameters (total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) Triglycerides, Apolipo protein B (ApoB), Apolipo protein A (ApoA), waist circumference, visceral adipose tissue (VAT) by dual-energy X-ray absorptiometry (DXA) in overweight subjects with newly diagnosed IFG. Fifty-four subjects (females/males 26/28, mean ± SD age 51.5 ± 6.2) were randomly assigned to the supplemented group ( n = 27) and placebo ( n = 27). After multiple testing correction, statistically significant interactions between time and group were observed for the primary endpoint glycemia (β = 0.36, p < 0.0001) and for the secondary endpoints HDL (β = -0.10, p < 0.0001), total cholesterol/HDL (β = 0.27, p < 0.0001), LDL (β = 0.15, p = 0.005), LDL/HDL (β = 0.23, p = 0.001), insulin (β = 1.28, p = 0.04), glycated hemoglobin (β = 0.21, p = 0.0002), A1c-derived average glucose (β = 0.34, p = 0.0002), ApoB (β = 6.00, p = 0.01), ApoA (β = -4.50, p = 0.04), ApoB/ApoA (β = 0.08, p = 0.003), waist circumference (β = 1.89, p = 0.05), VATβ = 222.37, p = 0.005). In conclusion, these results confirm that Cs supplementation has a significant effect on metabolic parameters in IFG patients.",2020,"p = 0.04), glycated hemoglobin (β = 0.21, p = 0.0002), A1c-derived average glucose (β = 0.34, p = 0.0002), ApoB (β = 6.00, p = 0.01),","['Fifty-four subjects (females/males 26/28, mean ± SD age 51.5 ± 6.2', 'overweight subjects with newly diagnosed IFG', 'IFG patients', 'Overweight and Obese Class I Subjects with Newly Detected Impaired Fasting Glycemia']","['placebo', 'Placebo', 'Cynara Supplementation']","['total cholesterol/HDL', 'Impaired fasting glucose (IFG', 'waist circumference', 'primary endpoint glycemia', 'glycemic control, insulin sensitivity and other metabolic parameters (total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) Triglycerides, Apolipo protein B (ApoB), Apolipo protein A (ApoA), waist circumference, visceral adipose tissue (VAT) by dual-energy X-ray absorptiometry (DXA', 'metabolic parameters', 'glycated hemoglobin']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3853264', 'cui_str': 'Obese class I'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0771144', 'cui_str': 'Cynara Preparation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0377800', 'cui_str': 'protein B'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",54.0,0.147889,"p = 0.04), glycated hemoglobin (β = 0.21, p = 0.0002), A1c-derived average glucose (β = 0.34, p = 0.0002), ApoB (β = 6.00, p = 0.01),","[{'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Rondanelli', 'Affiliation': 'IRCCS Mondino Foundation, 27100 Pavia, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Riva', 'Affiliation': 'Research and Development Unit, Indena, 20139 Milan, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Petrangolini', 'Affiliation': 'Research and Development Unit, Indena, 20139 Milan, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Allegrini', 'Affiliation': 'Research and Development Unit, Indena, 20139 Milan, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Bernardinelli', 'Affiliation': 'Department of Brain and Behavioral Science, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Fazia', 'Affiliation': 'Department of Brain and Behavioral Science, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Peroni', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Gasparri', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Nichetti', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Milena Anna', 'Initials': 'MA', 'LastName': 'Faliva', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Naso', 'Affiliation': 'Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ""Istituto Santa Margherita"", University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Perna', 'Affiliation': 'Department of Biology, Sakhir Campus, College of Science, University of Bahrain, Sakheer P.O. Box 32038, Bahrain.'}]",Nutrients,['10.3390/nu12113298']
1397,33126555,"Impact of Physical Activity and Weight Loss on Fat Mass, Glucose Metabolism, and Inflammation in Older African Americans with Osteoarthritis.","(1) Background: There are currently very few interventions performed within a community setting that compare the effects of physical activity (PA) versus PA plus weight loss on cancer and chronic disease risk in older African Americans. Therefore, we investigated the impact of an 8 week (24 session) PA intervention compared to a PA plus weight loss intervention on fat mass, glucose metabolism, and markers of inflammation in older, overweight and obese African Americans. (2) Methods: Subjects were randomized to a PA ( n = 83) or PA plus weight loss ( n = 72) intervention that met three times weekly for 8 weeks. At baseline and post-intervention, anthropometrics, body composition, systemic inflammation (high-sensitivity C-reactive protein, tumor necrosis factor-α, and interleukin 6), fasting glucose, insulin and homeostasis model assessment-insulin resistance (HOMA-IR) were determined. (3) Results: Subjects had a mean age of 67 years (SD = 5.3) and were mostly women (88%). The PA plus weight loss group lost more total and visceral fat than the PA group (-4.0% vs. +0.6% and -4.1% vs. +3.7%, respectively, p < 0.01 for both). Changes in inflammation and glucose metabolism were similar between groups post-intervention. Within the PA plus weight loss group only, serum insulin and HOMA-IR decreased significantly. (4) Conclusions: PA combined with weight loss can decrease total and visceral fat mass and improve insulin sensitivity, confirming that these cancer- and chronic disease-related risk factors are influenced by relatively modest lifestyle changes in the short term.",2020,"At baseline and post-intervention, anthropometrics, body composition, systemic inflammation (high-sensitivity C-reactive protein, tumor necrosis factor-α, and interleukin 6), fasting glucose, insulin and homeostasis model assessment-insulin resistance (HOMA-IR) were determined.","['Older African Americans with Osteoarthritis', 'older, overweight and obese African Americans', 'Subjects had a mean age of 67 years (SD = 5.3) and were mostly women (88', 'older African Americans']","['Physical Activity and Weight Loss', 'PA', 'physical activity (PA) versus PA plus weight loss', 'PA plus weight loss intervention']","['anthropometrics, body composition, systemic inflammation (high-sensitivity C-reactive protein, tumor necrosis factor-α, and interleukin 6), fasting glucose, insulin and homeostasis model assessment-insulin resistance (HOMA-IR', 'inflammation and glucose metabolism', 'total and visceral fat mass and improve insulin sensitivity', 'total and visceral fat', 'serum insulin and HOMA-IR', 'Fat Mass, Glucose Metabolism, and Inflammation']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",,0.0259348,"At baseline and post-intervention, anthropometrics, body composition, systemic inflammation (high-sensitivity C-reactive protein, tumor necrosis factor-α, and interleukin 6), fasting glucose, insulin and homeostasis model assessment-insulin resistance (HOMA-IR) were determined.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McLeod', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Castellanos', 'Affiliation': 'Department of Medicine, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'DeMott', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Olender', 'Affiliation': 'Department of Medicine, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Fitzgibbon', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, USA.'}, {'ForeName': 'Giamila', 'Initials': 'G', 'LastName': 'Fantuzzi', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tussing-Humphreys', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL 60612, USA.'}]",Nutrients,['10.3390/nu12113299']
1398,33126692,Optimising Web-Based Computer-Tailored Physical Activity Interventions for Prostate Cancer Survivors: A Randomised Controlled Trial Examining the Impact of Website Architecture on User Engagement.,"BACKGROUND
Web-based computer-tailored interventions can assist prostate cancer survivors to become more physically active by providing personally relevant behaviour change support. This study aimed to explore how changing the website architecture (free choice vs. tunnelled) impacted engagement within a physical activity computer-tailored intervention targeting prostate cancer survivors.
METHODS
On a 2:2:1 ratio, 71 Australian prostate cancer survivors with local or locally advanced disease (mean age: 66.6 years ± 9.66) were randomised into either a free-choice (N = 27), tunnelled (N = 27) or minimal intervention control arm (N =17). The primary outcome was differences in usage of the physical activity self-monitoring and feedback modules between the two intervention arms. Differences in usage of other website components between the two intervention groups were explored as secondary outcomes. Further, secondary outcomes involving comparisons between all study groups (including the control) included usability, personal relevance, and behaviour change.
RESULTS
The average number of physical activity self-monitoring and feedback modules accessed was higher in the tunnelled arm (M 2.6 SD 1.3) compared to the free-choice arm (M 1.5 SD 1.4), p = 0.01. However, free-choice participants were significantly more likely to have engaged with the social support ( p = 0.008) and habit formation ( p = 0.003) 'once-off' modules compared to the standard tunnelled arm. There were no other between-group differences found for any other study outcomes.
CONCLUSION
This study indicated that website architecture influences behavioural engagement. Further research is needed to examine the impact of differential usage on mechanisms of action and behaviour change.",2020,"The average number of physical activity self-monitoring and feedback modules accessed was higher in the tunnelled arm (M 2.6 SD 1.3) compared to the free-choice arm (M 1.5 SD 1.4), p = 0.01.","['71 Australian prostate cancer survivors with local or locally advanced disease (mean age: 66.6 years ± 9.66', 'Prostate Cancer Survivors', 'prostate cancer survivors']","['Optimising Web-Based Computer-Tailored Physical Activity Interventions', 'physical activity computer-tailored intervention', 'minimal intervention control']","['habit formation', 'usage of the physical activity self-monitoring and feedback modules', 'usability, personal relevance, and behaviour change', 'average number of physical activity self-monitoring and feedback modules']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",71.0,0.0797526,"The average number of physical activity self-monitoring and feedback modules accessed was higher in the tunnelled arm (M 2.6 SD 1.3) compared to the free-choice arm (M 1.5 SD 1.4), p = 0.01.","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Finlay', 'Affiliation': ""The Freemasons Foundation Centre for Men's Health, School of Medicine, University of Adelaide, Adelaide 5000, SA, Australia.""}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Evans', 'Affiliation': ""The Freemasons Foundation Centre for Men's Health, School of Medicine, University of Adelaide, Adelaide 5000, SA, Australia.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Vincent', 'Affiliation': ""The Freemasons Foundation Centre for Men's Health, School of Medicine, University of Adelaide, Adelaide 5000, SA, Australia.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wittert', 'Affiliation': ""The Freemasons Foundation Centre for Men's Health, School of Medicine, University of Adelaide, Adelaide 5000, SA, Australia.""}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'Physical Activity Research Group, Appleton Institute, Central Queensland University, Rockhampton 4701, QLD, Australia.'}, {'ForeName': 'Camille E', 'Initials': 'CE', 'LastName': 'Short', 'Affiliation': ""The Freemasons Foundation Centre for Men's Health, School of Medicine, University of Adelaide, Adelaide 5000, SA, Australia.""}]",International journal of environmental research and public health,['10.3390/ijerph17217920']
1399,33127579,"Sonication of the anterior thalamus with MRI-Guided transcranial focused ultrasound (tFUS) alters pain thresholds in healthy adults: A double-blind, sham-controlled study.","BACKGROUND
Transcranial focused ultrasound (tFUS) is a noninvasive brain stimulation method that may modulate deep brain structures. This study investigates whether sonication of the right anterior thalamus would modulate thermal pain thresholds in healthy individuals.
METHODS
We enrolled 19 healthy individuals in this three-visit, double-blind, sham-controlled, crossover trial. Participants first underwent a structural MRI scan used solely for tFUS targeting. They then attended two identical experimental tFUS visits (counterbalanced by condition) at least one week apart. Within the MRI scanner, participants received two, 10-min sessions of either active or sham tFUS spread 10 min apart targeting the right anterior thalamus [fundamental frequency: 650 kHz, Pulse repetition frequency: 10 Hz, Pulse Width: 5 ms, Duty Cycle: 5%, Sonication Duration: 30s, Inter-Sonication Interval: 30 s, Number of Sonications: 10, ISPTA. 0 995 mW/cm2, ISPTA. 3 719 mW/cm2, Peak rarefactional pressure 0.72 MPa]. The primary outcome measure was quantitative sensory thresholding (QST), measuring sensory, pain, and tolerance thresholds to a thermal stimulus applied to the left forearm before and after right anterior thalamic tFUS.
RESULTS
The right anterior thalamus was accurately sonicated in 17 of the 19 subjects. Thermal pain sensitivity was significantly attenuated after active tFUS. The pre-post x active-sham interaction was significant (F(1,245.95) = 4.03, p = .046). This interaction indicates that in the sham stimulation condition, thermal pain thresholds decreased 1.08 °C (SE = 0.28) pre-post session, but only decreased .51 °C (SE = 0.30) pre-post session in the active stimulation group.
CONCLUSIONS
Two 10-min sessions of anterior thalamic tFUS induces antinociceptive effects in healthy individuals. Future studies should optimize the parameter space, dose and duration of this effect which may lead to multi-session tFUS interventions for pain disorders.",2020,"This interaction indicates that in the sham stimulation condition, thermal pain thresholds decreased 1.08ºC (SE=.28) pre-post session, but only decreased .51ºC","['Healthy Adults', '19 healthy individuals', 'healthy individuals']","['structural MRI scan', 'tFUS', 'active or sham tFUS spread 10 minutes apart targeting the right anterior thalamus [fundamental frequency: 650kHz, Pulse repetition frequency', 'MRI-Guided Transcranial Focused Ultrasound', 'Transcranial focused ultrasound (tFUS']","['right anterior thalamus', 'quantitative sensory thresholding (QST), measuring sensory, pain, and tolerance thresholds to a thermal stimulus applied to the left forearm before and after right anterior thalamic tFUS', 'Thermal pain sensitivity', 'antinociceptive effects', 'thermal pain thresholds']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0441997', 'cui_str': 'Right anterior'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0441997', 'cui_str': 'Right anterior'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",19.0,0.31872,"This interaction indicates that in the sham stimulation condition, thermal pain thresholds decreased 1.08ºC (SE=.28) pre-post session, but only decreased .51ºC","[{'ForeName': 'Bashar W', 'Initials': 'BW', 'LastName': 'Badran', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA. Electronic address: badran@musc.edu.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Caulfield', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Stomberg-Firestein', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Philipp M', 'Initials': 'PM', 'LastName': 'Summers', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Logan T', 'Initials': 'LT', 'LastName': 'Dowdle', 'Affiliation': 'Center for Magnetic Resonance Research, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Savoca', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Xingbao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Austelle', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'E Baron', 'Initials': 'EB', 'LastName': 'Short', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Borckardt', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Spivak', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bystritsky', 'Affiliation': 'BrainSonix Corporation, Sherman Oaks, CA, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.10.007']
1400,33127581,Transcutaneous auricular vagus nerve stimulation enhances learning of novel letter-sound relationships in adults.,"BACKGROUND
Reading is a critical skill in modern society but is significantly more difficult to acquire during adulthood. Many adults are required to learn a new orthography after this window closes for personal or vocational reasons and while many programs and training methods exist for learning to read in adulthood, none result in native-like fluency. Implantable cervical vagus nerve stimulation is capable of driving neural plasticity but is invasive and not practical as a reading intervention.
OBJECTIVE
The goal of the current study was to evaluate whether non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) is effective at enhancing novel orthography acquisition in young adults.
METHODS
We enrolled 37 typically developing participants and randomly assigned them to a computer control, device sham control, earlobe stimulation control, or experimental transcutaneous auricular stimulation (taVNS) group. Participants then learned novel letter-sound correspondences in Hebrew over five training lessons. Performance was assessed using three measures to evaluate various aspects of reading: Letter ID, Automaticity, and Decoding.
RESULTS
The taVNS group significantly outperformed the three control groups on both the Automaticity and Decoding tasks. There was no difference on the Letter ID task.
CONCLUSIONS
These results demonstrate, for the first time, that taVNS is capable of improving aspects of reading acquisition in adults. These findings have potential implications for a wide range of cognitive tasks.",2020,"Implantable cervical vagus nerve stimulation is capable of driving neural plasticity but is invasive and not practical as a reading intervention.
","['Adults', 'young adults']","['non-invasive transcutaneous auricular vagus nerve stimulation (taVNS', 'computer control, device sham control, earlobe stimulation control, or experimental transcutaneous auricular stimulation (taVNS) group', 'Transcutaneous Auricular Vagus Nerve Stimulation']","['reading: Letter ID, Automaticity, and Decoding', 'Letter ID task', 'Automaticity and Decoding tasks']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",37.0,0.0476777,"Implantable cervical vagus nerve stimulation is capable of driving neural plasticity but is invasive and not practical as a reading intervention.
","[{'ForeName': 'Vishal J', 'Initials': 'VJ', 'LastName': 'Thakkar', 'Affiliation': 'Department of Psychology, Texas Christian University, Fort Worth, TX, 76129, USA. Electronic address: vishalthakkar0415@gmail.com.'}, {'ForeName': 'Abby S', 'Initials': 'AS', 'LastName': 'Engelhart', 'Affiliation': 'Department of Psychology, Texas Christian University, Fort Worth, TX, 76129, USA. Electronic address: abby.mason@tcu.edu.'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Khodaparast', 'Affiliation': 'Nexeon MedSystems, Inc., Dallas, TX, 75231, USA. Electronic address: navid.khodaparast@sparkbiomedical.com.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Abadzi', 'Affiliation': 'Department of Psychology, University of Texas Arlington, Arlington, TX, 76019, USA. Electronic address: habadzi@gmail.com.'}, {'ForeName': 'Tracy M', 'Initials': 'TM', 'LastName': 'Centanni', 'Affiliation': 'Department of Psychology, Texas Christian University, Fort Worth, TX, 76129, USA. Electronic address: tmcentanni@gmail.com.'}]",Brain stimulation,['10.1016/j.brs.2020.10.012']
1401,33127637,Proactive telephone-based peer support for breastfeeding: a cross-sectional survey of women's experiences of receiving support in the RUBY randomised controlled trial.,"OBJECTIVE
The Ringing Up about Breastfeeding earlY (RUBY) randomised controlled trial (RCT) of proactive telephone-based peer support for breastfeeding found that infants of women allocated to the intervention were more likely to be receiving breast milk at 6 months of age than those receiving usual care. This study explores women's experiences of receiving the RUBY peer support intervention.
DESIGN
Cross-sectional survey.
SETTING
Women were recruited from the postnatal units of three tertiary hospitals in Melbourne, Australia.
PARTICIPANTS
Women allocated to receive telephone peer support in the RUBY RCT who completed a telephone interview at 6 months postpartum (501/574 (87%) in trial intervention arm) were invited to complete a postal survey on their experience of receiving support.
OUTCOMES
Experiences of support from the allocated peer, perceived helpfulness, topics discussed, overall satisfaction with the support and frequency and duration of contact were explored.
RESULTS
Surveys were sent between August 2013 and March 2016, and 72% (360/501) responded of whom 341 recalled receiving peer support. Women reported high levels of perceived helpfulness (79%) and overall satisfaction with the peer support (93%). Discussions included breastfeeding topics (milk supply, attachment), baby care, baby behaviour, and reassurance and emotional support. Women valued the practical and realistic support from another mother, as well as the proactive nature, continuity and accessibility of the support. The empathy, reassurance and encouragement provided helped the mothers to 'cope', to continue breast feeding and to feel empowered.
CONCLUSION
Most respondents were positive about their experience of receiving proactive telephone peer support for breastfeeding, further supporting the roll-out of this model as a strategy for increasing breastfeeding maintenance to 6 months. Recommendations include flexibility in the scheduling of calls according to individual need, and the use of text messages in conjunction with proactive calls, to enhance and facilitate communication between the peer and the mother.
TRIAL REGISTRATION NUMBER
ACTRN12612001024831.",2020,Women reported high levels of perceived helpfulness (79%) and overall satisfaction with the peer support (93%).,"['Surveys were sent between August 2013 and March 2016, and 72% (360/501) responded of whom 341 recalled receiving peer support', 'Women were recruited from the postnatal units of three tertiary hospitals in Melbourne, Australia', 'Women allocated to receive']","['proactive telephone-based peer support', 'Proactive telephone-based peer support for breastfeeding', 'telephone peer support in the RUBY RCT who completed a telephone interview']","['breastfeeding topics (milk supply, attachment), baby care, baby behaviour, and reassurance and emotional support', 'overall satisfaction', 'perceived helpfulness, topics discussed, overall satisfaction with the support and frequency and duration of contact']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0021272', 'cui_str': 'Infant care'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0204558', 'cui_str': 'Group reassurance'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",,0.0696554,Women reported high levels of perceived helpfulness (79%) and overall satisfaction with the peer support (93%).,"[{'ForeName': 'Fiona E', 'Initials': 'FE', 'LastName': 'McLardie-Hore', 'Affiliation': ""Midwifery and Maternity Services Research, Royal Women's Hospital, Parkville, Victoria, Australia Fiona.McLardieHore@thewomens.org.au.""}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'McLachlan', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Touran', 'Initials': 'T', 'LastName': 'Shafiei', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Della A', 'Initials': 'DA', 'LastName': 'Forster', 'Affiliation': ""Midwifery and Maternity Services Research, Royal Women's Hospital, Parkville, Victoria, Australia.""}]",BMJ open,['10.1136/bmjopen-2020-040412']
1402,33127945,Acute pain and side effects after tramadol in breast cancer patients: results of a prospective double-blind randomized study.,"The objective of this study was to evaluate the severity of acute pain and side effects in breast cancer patients postoperatively treated with two regimens of tramadol with paracetamol in a prospective double-blind study. Altogether 117 breast cancer patients who had axillary lymphadenectomy were randomized into two analgesic study groups and the analgesic treatment lasted 4 weeks. Stronger analgesia group received every 8 h 75/650 mg of tramadol with paracetamol, while weaker analgesia group received every 8 h 37.5/325 mg of tramadol with paracetamol. Patients with the higher dose of tramadol had less pain during the 1st and 4th week than patients with the lower dose. Frequency of nausea, vomiting, lymphedema or range of shoulder movement was not significantly different between the two groups of patients. Constipation was significantly more common in the group with stronger analgesia during the 2nd week in comparison to patients with weaker analgesia. The patients who were on 75/650 mg of tramadol with paracetamol had less pain in comparison to patients who were on 37.5/325 mg. Side effects were mild, but common in both groups of patients.",2020,"Frequency of nausea, vomiting, lymphedema or range of shoulder movement was not significantly different between the two groups of patients.","['breast cancer patients postoperatively treated with two regimens of', 'Altogether 117 breast cancer patients who had axillary lymphadenectomy', 'breast cancer patients']","['tramadol', 'tramadol with paracetamol', 'tramadol with paracetamol, while weaker analgesia group received every 8\xa0h 37.5/325\xa0mg of tramadol with paracetamol']","['Frequency of nausea, vomiting, lymphedema or range of shoulder movement', 'Constipation', 'Acute pain and side effects', 'acute pain and side effects', 'pain']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0427048', 'cui_str': 'Movement of shoulder'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",117.0,0.221722,"Frequency of nausea, vomiting, lymphedema or range of shoulder movement was not significantly different between the two groups of patients.","[{'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Besic', 'Affiliation': 'Department of Surgical Oncology, Institute of Oncology, Zaloska 2, 1000, Ljubljana, Slovenia. nbesic@onko-i.si.'}, {'ForeName': 'Jaka', 'Initials': 'J', 'LastName': 'Smrekar', 'Affiliation': 'Faculty of Mathematics and Physics, University of Ljubljana, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Branka', 'Initials': 'B', 'LastName': 'Strazisar', 'Affiliation': 'Department of Anesthesiology, Institute of Oncology, Zaloska 2, 1000, Ljubljana, Slovenia.'}]",Scientific reports,['10.1038/s41598-020-75961-2']
1403,33127947,Changes in peripheral immune populations during pregnancy and modulation by probiotics and ω-3 fatty acids.,"Allergic diseases have become a major health problem, partly due to reduced microbial stimulation and a decreased dietary ω-3/ω-6 long-chain polyunsaturated fatty acid ratio. Prenatal exposures have been reported to influence allergy development, possibly induced via changes in maternal immune regulation. In a randomized double-blind placebo-controlled multicenter allergy prevention trial (PROOM-3), pregnant women were recruited at gestational week 20, and randomized to four study groups, one receiving both L. reuteri oil drops and ω-3 PUFA capsules (n = 22), the second receiving ω-3 PUFA supplementation and placebo regarding L. reuteri (n = 21), the third receiving L. reuteri and placebo regarding ω-3 PUFA (n = 22) and the fourth group receiving placebo capsules and placebo oil drops (n = 23). In this substudy, supplemental and pregnancy-related effects on maternal peripheral immune cell populations during pregnancy were assessed by flow cytometry immune phenotyping at gestational week 20, 32 and 4 days after delivery. The numbers of activated and regulatory T (Treg) cells (CD45RA - Foxp3 ++ /CD45RA + Foxp3 + ) were reduced after delivery, with the lowest count in the L. reuteri supplemented group compared with the placebo group 4 days after delivery, while the ω-3 PUFA group did not differ from the placebo group. Several treatment-independent changes were observed during and after pregnancy in lymphocytes (CD4 + /8 + /19 + /56 + /45RA +/- ), CD14 + 16 +/- monocytes, and in subpopulations of T helper cells (Th) CD4 + CD45RA - Tbet + (Th1) and CD4 + CD45RA - RORC + (Th17) cells. In conclusion, probiotic supplementation to the mother during the second half of pregnancy resulted in immunomodulatory effects among activated and resting Treg cells. Furthermore, several systemic immune modifying effects of pregnancy were observed.",2020,"Several treatment-independent changes were observed during and after pregnancy in lymphocytes (CD4 + /8 + /19 + /56 + /45RA +/- ), CD14 + 16 +/- ",['pregnant women were recruited at gestational week 20'],"['CD14 + 16 ', 'probiotic supplementation', 'placebo', 'L. reuteri oil drops and ω-3 PUFA capsules', 'placebo capsules and placebo oil drops', 'ω-3 PUFA supplementation and placebo']","['monocytes, and in subpopulations of T helper cells (Th) CD4 + CD45RA - Tbet + (Th1) and CD4 + CD45RA - RORC + (Th17) cells', 'numbers of activated and regulatory T (Treg) cells (CD45RA - Foxp3 ++ /CD45RA + Foxp3 + ']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0018894', 'cui_str': 'Helper cell'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0108789', 'cui_str': 'Lymphocyte antigen CD45RA'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C2724208', 'cui_str': '++'}]",,0.341412,"Several treatment-independent changes were observed during and after pregnancy in lymphocytes (CD4 + /8 + /19 + /56 + /45RA +/- ), CD14 + 16 +/- ","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Forsberg', 'Affiliation': 'Division of Neuro and Inflammation Sciences, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden. annfo663@gmail.com.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Abrahamsson', 'Affiliation': 'Department of Paediatrics, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Nilsson', 'Affiliation': 'Department of Clinical and Experimental Medicine, Allergy Centre, Linköping University, Linköping, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ernerudh', 'Affiliation': 'Department of Clinical Immunology and Transfusion Medicine, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Duchén', 'Affiliation': 'Department of Paediatrics, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Jenmalm', 'Affiliation': 'Division of Neuro and Inflammation Sciences, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}]",Scientific reports,['10.1038/s41598-020-75312-1']
1404,33127948,A randomized controlled trial of resistance and balance exercise for sarcopenic patients aged 80-99 years.,"We compared a mixed exercise program (i.e., balance exercise plus resistance exercise) with resistance exercise in a single-blind, randomized controlled trial in a post-acute care unit. In total, 60 sarcopenic patients were randomly assigned to an intervention group (12-week mixed exercise) and a control group (12-week resistance exercise). The primary outcomes were the change of the Barthel Index and the number of fallers. The intervention group showed a mean increase of 9.5 points on the Barthel Index (95% confidence interval (CI) 3.9-15.1), while the control group showed a mean increase of 6.3 points (95% CI 2.3-10.4). The mixed exercise program provided a significant benefit over resistance exercise (adjusted mean difference of the change of Barthel Index: 6.8 points; 95% CI 1.4-12.1). The number of fallers was 13.3% and 23.3% in the intervention and control groups, respectively, but the difference was not significant (risk ratio (RR) 0.89, 95% CI 0.69-1.13, p = 0.506). In conclusion, compared with resistance exercise, the mixed exercise program appears to further improve the activities of daily living and physical performance in our study population. Under the monitoring of experienced physiotherapists, both exercise programs are feasible and safe for this population.",2020,"The intervention group showed a mean increase of 9.5 points on the Barthel Index (95% confidence interval (CI) 3.9-15.1), while the control group showed a mean increase of 6.3 points (95% CI 2.3-10.4).","['60 sarcopenic patients', 'sarcopenic patients aged 80-99\xa0years']","['control group (12-week resistance exercise', 'mixed exercise program', 'intervention group (12-week mixed exercise', 'resistance and balance exercise', 'resistance exercise, the mixed exercise program', 'mixed exercise program (i.e., balance exercise plus resistance exercise) with resistance exercise']","['number of fallers', 'change of the Barthel Index and the number of fallers', 'activities of daily living and physical performance', 'Barthel Index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",60.0,0.176726,"The intervention group showed a mean increase of 9.5 points on the Barthel Index (95% confidence interval (CI) 3.9-15.1), while the control group showed a mean increase of 6.3 points (95% CI 2.3-10.4).","[{'ForeName': 'Yuxiang', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Rehabilitation Medicine Center, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Chengdu, China.'}, {'ForeName': 'Renjie', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Rehabilitation Medicine Center, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Chengdu, China.'}, {'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Rehabilitation Medicine Center, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Chengdu, China.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Center of Gerontology and Geriatrics, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Chengdu, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Center of Gerontology and Geriatrics, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Chengdu, China. yangmier@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-75872-2']
1405,33127967,Preoperative communication with anesthetists via anesthesia service platform (ASP) helps alleviate patients' preoperative anxiety.,"Female gender has been identified as one of the risk factors closely linked to perioperative anxiety and a lower level of satisfaction. A successful preoperative anesthesia education may improve such negative outcomes. The aim of this study was to investigate whether preoperative anesthesia education via an Anesthesia Service Platform (ASP) could reduce the anxiety levels in female patients scheduled for laparoscopic cholecystectomy under general anesthesia, and accelerate rehabilitation. A total of 222 patients scheduled for elective laparoscopic cholecystectomy were randomly assigned to the control group and the ASP group. Patients' baseline and post-intervention psychological status was measured by the State-Trait Anxiety Inventory and General Well-Being Schedule. Pain management and recovery were assessed by VAS every 12 h for 48 h after surgery; length of stay (LOS) and postoperative analgesic consumption were also assessed. Patients in the control group experienced higher anxiety levels before surgery and had longer LOS than those in the ASP group. Patients in the ASP group had a higher general well-being score; however, they suffered more pain and consumed more analgesics after surgery. ASP is effective for preventing anxiety in female patients before laparoscopic cholecystectomy, improving patients' general well-being levels, and shortening their LOS, but negatively influences patients' postoperative pain levels.",2020,Patients' baseline and post-intervention psychological status was measured by the State-Trait Anxiety Inventory and General Well-Being Schedule.,"['female patients scheduled for laparoscopic cholecystectomy under general anesthesia, and accelerate rehabilitation', 'female patients before', '222 patients scheduled for elective laparoscopic cholecystectomy']","['laparoscopic cholecystectomy', 'ASP', 'Preoperative communication with anesthetists via anesthesia service platform (ASP', 'preoperative anesthesia education via an Anesthesia Service Platform (ASP']","['higher anxiety levels', 'anxiety levels', 'Pain management and recovery', 'length of stay (LOS) and postoperative analgesic consumption']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",222.0,0.02412,Patients' baseline and post-intervention psychological status was measured by the State-Trait Anxiety Inventory and General Well-Being Schedule.,"[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, People's Republic of China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Peng', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, People's Republic of China.""}, {'ForeName': 'Qiange', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, People's Republic of China.""}, {'ForeName': 'Meihan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ""Southwest Medical University, Luzhou, People's Republic of China.""}, {'ForeName': 'Guangxiang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""Department of Radiology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, People's Republic of China.""}, {'ForeName': 'Maohua', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, People's Republic of China. wangmaohua@swmu.edu.cn.""}]",Scientific reports,['10.1038/s41598-020-74697-3']
1406,33127971,Growth hormone alleviates oxidative stress and improves oocyte quality in Chinese women with polycystic ovary syndrome: a randomized controlled trial.,"Oxidative stress (OS) is associated with poor oocyte quality and in vitro fertilization and embryo transfer (IVF-ET) outcomes for patients with polycystic ovary syndrome (PCOS). Growth hormone (GH) can function to reduce OS in some types of cells. Therefore, this prospective randomized study investigated whether GH can significantly improve OS and oocyte quality in women with PCOS. This study enrolled 109 and 50 patients with and without PCOS (controls), respectively. The patients with PCOS were randomly assigned to receive treatment with GH (PCOS-T) or not (PCOS-C). The primary outcome included markers of OS in serum and FF, and secondary outcomes were mitochondrial function in granulosa cells (GCs) and IVF-ET outcomes. The PCOS groups showed higher basal serum total oxidant status (TOS) and OS index (OSI) levels. The follicle fluid (FF) TOS and OSI and GC apoptosis rate were significantly higher, whereas the GC mitochondrial membrane potential (MMP) was significantly lower in the PCOS-C group than in the PCOS-T and non-PCOS control groups (P < 0.05). Significantly more oocytes were fertilised and cleavage stage embryos were produced in the PCOS-T group than in the PCOS-C group (P < 0.05). GH also improved the rates of implantation and clinical pregnancy, but not significantly (P > 0.05). This study showed that GH alleviated the TOS and OSI level in FF and improved GC mitochondrial dysfunction and oocyte quality in patients with PCOS.Clinical Trial Registration Number: This project was prospectively registered on the Chinese Clinical Trial Registry on October 20, 2018. (ChiCTR1800019437) ( https://www.chictr.org.cn/edit.aspx?pid=28663&htm=4 ).",2020,Significantly more oocytes were fertilised and cleavage stage embryos were produced in the PCOS-T group than in the PCOS-C group (P < 0.05).,"['patients with polycystic ovary syndrome (PCOS', 'Chinese women with polycystic ovary syndrome', 'enrolled 109 and 50 patients with and without PCOS (controls), respectively', 'patients with PCOS', 'patients with PCOS.Clinical Trial Registration Number: This project was prospectively registered on the Chinese Clinical Trial Registry on October 20, 2018', 'women with PCOS']","['GH (PCOS-T) or not (PCOS-C', 'GH', 'Growth hormone alleviates oxidative stress', 'Growth hormone (GH']","['TOS and OSI level', 'rates of implantation and clinical pregnancy', 'basal serum total oxidant status (TOS) and OS index (OSI) levels', 'fertilised and cleavage stage embryos', 'GC mitochondrial dysfunction and oocyte quality', 'GC mitochondrial membrane potential (MMP', 'markers of OS in serum and FF, and secondary outcomes were mitochondrial function in granulosa cells (GCs) and IVF-ET outcomes', 'oocyte quality', 'follicle fluid (FF) TOS and OSI and GC apoptosis rate', 'Oxidative stress (OS', 'OS and oocyte quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1720920', 'cui_str': 'Mitochondrial Membrane Potential'}, {'cui': 'C0025251', 'cui_str': 'Transmembrane Potentials'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}]",,0.180794,Significantly more oocytes were fertilised and cleavage stage embryos were produced in the PCOS-T group than in the PCOS-C group (P < 0.05).,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Fan', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Jin', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Huili', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Deng', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Quan', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China. Weihuang64@163.com.""}]",Scientific reports,['10.1038/s41598-020-75107-4']
1407,33127993,Lithium modulates striatal reward anticipation and prediction error coding in healthy volunteers.,"Lithium is one of the most effective mood-stabilizing medications in bipolar disorder. This study was designed to test whether lithium administration may stabilize mood via effects on reward processing. It was hypothesized that lithium administration would modulate reward processing in the striatum and affect both anticipation and outcome computations. Thirty-seven healthy human participants (18 males, 33 with suitable fMRI data) received 11 (±1) days of lithium carbonate or placebo intervention (double-blind), after which they completed the monetary incentive delay task while fMRI data were collected. The monetary incentive delay task is a robust task with excellent test-retest reliability and is well suited to investigate different phases of reward processing within the caudate and nucleus accumbens. To test for correlations with prediction error signals a Rescorla-Wagner reinforcement-learning model was applied. Lithium administration enhanced activity in the caudate during reward anticipation compared to placebo. In contrast, lithium administration reduced caudate and nucleus accumbens activity during reward outcome. This latter effect seems related to learning as reward prediction errors showed a positive correlation with caudate and nucleus accumbens activity during placebo, which was absent after lithium administration. Lithium differentially modulates the anticipation relative to the learning of rewards. This suggests that lithium might reverse dampened reward anticipation while reducing overactive reward updating in patients with bipolar disorder. This specific effect of lithium suggests that a targeted modulation of reward learning may be a viable approach for novel interventions in bipolar disorder.",2020,Lithium administration enhanced activity in the caudate during reward anticipation compared to placebo.,"['patients with bipolar disorder', 'healthy volunteers', 'Thirty-seven healthy human participants (18 males, 33 with suitable fMRI data) received 11 (±1) days of']","['lithium', 'placebo', 'lithium carbonate or placebo intervention', 'Lithium']",['caudate and nucleus accumbens activity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085217', 'cui_str': 'Lithium Carbonate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",37.0,0.255793,Lithium administration enhanced activity in the caudate during reward anticipation compared to placebo.,"[{'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Volman', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK. volman.inge@gmail.com.'}, {'ForeName': 'Abbie', 'Initials': 'A', 'LastName': 'Pringle', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Verhagen', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging Neuroimaging (WIN), Centre for Functional MRI of the Brain (FMRIB), Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Browning', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Phil J', 'Initials': 'PJ', 'LastName': 'Cowen', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00895-2']
1408,33098483,Healthy Choices Intervention is Associated with Reductions in Stigma Among Youth Living with HIV in the United States (ATN 129).,"Considering the lack of validated stigma reduction interventions for youth living with HIV (YLWH), we evaluated effects of the Healthy Choices intervention on HIV-related stigma among YLWH. We analyzed data from the Adolescent Medicine Trials Network protocol 129, multi-site randomized controlled trial, applying latent growth curve modeling with two linear slopes estimating changes in Berger's Stigma Scale pre-intervention, 16, 28, and 52 weeks post-intervention, as well as the trajectory of stigma scores over the follow-up period (N = 183). Expected value for the growth intercept was statistically significant (B intercept = 2.53; 95% CI 2.32, 2.73; p < 0.001), as were differences in the change from baseline to 16-week follow-up (B intercept slope1 = - 0.02; 95% CI - 0.04, 0.01; p = 0.034). Expected value of the slope factor measuring growth over the follow-up period was non-significant suggesting that stigma scores were stable from 28 to 52 weeks. Our findings warrant replication and additional research comparing effects of this intervention to counterfactual controls.",2020,"Expected value for the growth intercept was statistically significant (B intercept = 2.53; 95% CI 2.32, 2.73; p < 0.001), as were differences in the change from baseline to 16-week follow-up (B intercept slope1 = - 0.02; 95% CI - 0.04, 0.01; p = 0.034).","['youth living with HIV (YLWH', 'Youth Living with HIV in the United States (ATN 129']",[],['stigma scores'],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4551504', 'cui_str': 'Tyrosinase-negative oculocutaneous albinism'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.106599,"Expected value for the growth intercept was statistically significant (B intercept = 2.53; 95% CI 2.32, 2.73; p < 0.001), as were differences in the change from baseline to 16-week follow-up (B intercept slope1 = - 0.02; 95% CI - 0.04, 0.01; p = 0.034).","[{'ForeName': 'Henna', 'Initials': 'H', 'LastName': 'Budhwani', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham (UAB), 330C Ryals Public Health Building, 1665 University Boulevard, Birmingham, AL, 35294, USA. budhwani@uab.edu.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Robles', 'Affiliation': 'School of Social Work, Rutgers University, New Brunswick, NJ, USA.'}, {'ForeName': 'Tyrel J', 'Initials': 'TJ', 'LastName': 'Starks', 'Affiliation': 'Department of Psychology, Hunter College of the City University of New York (CUNY), New York, NY, USA.'}, {'ForeName': 'Karen Kolmodin', 'Initials': 'KK', 'LastName': 'MacDonell', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, School of Medicine, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Dinaj', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, School of Medicine, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Naar', 'Affiliation': 'Center for Translational Behavioral Science, Florida State University College of Medicine, Tallahassee, FL, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03071-1']
1409,33098800,Effects of intensive versus standard blood pressure control on domain-specific cognitive function: a substudy of the SPRINT randomised controlled trial.,"BACKGROUND
Results from the Systolic Blood Pressure Intervention Trial (SPRINT) showed that intensive control of systolic blood pressure significantly reduced the occurrence of mild cognitive impairment, but not probable dementia. We investigated the effects of intensive lowering of systolic blood pressure on specific cognitive functions in a preplanned substudy of participants from SPRINT.
METHODS
SPRINT was an open-label, multicentre, randomised controlled trial undertaken at 102 sites, including academic medical centres, Veterans Affairs medical centres, hospitals, and independent clinics, in the USA and Puerto Rico. Participants were adults aged 50 years or older with systolic blood pressure higher than 130 mm Hg, but without diabetes, history of stroke, or dementia. Participants were randomly assigned (1:1) to a systolic blood pressure goal of less than 120 mm Hg (intensive treatment) versus less than 140 mm Hg (standard treatment). All major classes of antihypertensive agents were included. A subgroup of randomly assigned participants including, but not limited to, participants enrolled in an MRI substudy was then selected for a concurrent substudy of cognitive function (target 2800 participants). Each individual was assessed with a screening cognitive test battery and an extended cognitive test battery at baseline and biennially during the planned 4-year follow-up. The primary outcomes for this substudy were standardised composite scores for memory (Logical Memory I and II, Modified Rey-Osterrieth Complex Figure [immediate recall], and Hopkins Verbal Learning Test-Revised [delayed recall]) and processing speed (Trail Making Test and Digit Symbol Coding). SPRINT was registered with ClinicalTrials.gov, NCT01206062.
FINDINGS
From Nov 23, 2010, to Dec 28, 2012, 2921 participants (mean age 68·4 years [SD 8·6], 1080 [37%] women) who had been randomly assigned in SPRINT were enrolled in the substudy (1448 received intensive treatment and 1473 received standard treatment). SPRINT was terminated early due to benefit observed in the primary outcome (composite of cardiovascular events). After a median follow-up of 4·1 years (IQR 3·7-5·8), there was no between-group difference in memory, with an annual decline in mean standardised domain score of -0·005 (95% CI -0·010 to 0·001) in the intensive treatment group and -0·001 (-0·006 to 0·005) in the standard treatment group (between-group difference -0·004, 95% CI -0·012 to 0·004; p=0·33). Mean standardised processing speed domain scores declined more in the intensive treatment group (between-group difference -0·010, 95% CI -0·017 to -0·002; p=0·02), with an annual decline of -0·025 (-0·030 to -0·019) for the intensive treatment group and -0·015 (-0·021 to 0·009) for the standard treatment group.
INTERPRETATION
Intensive treatment to lower systolic blood pressure did not result in a clinically relevant difference compared with standard treatment in memory or processing speed in a subgroup of participants from SPRINT. The effect of blood pressure lowering might not be evident in specific domains of cognitive function, but instead distributed across multiple domains.
FUNDING
National Heart, Lung, and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute on Aging, National Institute of Neurological Disorders and Stroke, and the Alzheimer's Association.",2020,"Mean standardised processing speed domain scores declined more in the intensive treatment group (between-group difference -0·010, 95% CI -0·017 to -0·002; p=0·02), with an annual decline of -0·025 (-0·030 to -0·019) for the intensive treatment group and -0·015","['2921 participants (mean age 68·4 years [SD 8·6], 1080 [37%] women) who had been randomly assigned in SPRINT were enrolled in the substudy (1448 received intensive treatment and 1473 received standard treatment', 'Participants were adults aged 50 years or older with systolic blood pressure higher than 130 mm Hg, but without diabetes, history of stroke, or dementia', 'participants from SPRINT', '102 sites, including academic medical centres, Veterans Affairs medical centres, hospitals, and independent clinics, in the USA and Puerto Rico', 'participants enrolled in an MRI substudy was then selected for a concurrent substudy of cognitive function (target 2800 participants']","['systolic blood pressure goal of less than 120 mm Hg (intensive treatment', 'intensive lowering of systolic blood pressure', 'intensive versus standard blood pressure control']","['standardised composite scores for memory (Logical Memory I and II, Modified Rey-Osterrieth Complex Figure [immediate recall], and Hopkins Verbal Learning Test-Revised [delayed recall]) and processing speed (Trail Making Test and Digit Symbol Coding', 'Mean standardised processing speed domain scores', 'domain-specific cognitive function', 'systolic blood pressure']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5192768', 'cui_str': '1080'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4517680', 'cui_str': '2800'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4505408', 'cui_str': 'Rey-Osterrieth Complex Figure'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",2921.0,0.271982,"Mean standardised processing speed domain scores declined more in the intensive treatment group (between-group difference -0·010, 95% CI -0·017 to -0·002; p=0·02), with an annual decline of -0·025 (-0·030 to -0·019) for the intensive treatment group and -0·015","[{'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: srapp@wakehealth.edu.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Gaussoin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Bonnie C', 'Initials': 'BC', 'LastName': 'Sachs', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Chelune', 'Affiliation': 'Department of Neurology, University of Utah, School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Supiano', 'Affiliation': 'Department of Internal Medicine, University of Utah, School of Medicine, Salt Lake City, UT, USA; Veterans Affairs Salt Lake City Health Care System, Salt Lake City, UT, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Lerner', 'Affiliation': 'Department of Neurology, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Virginia G', 'Initials': 'VG', 'LastName': 'Wadley', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Valarie M', 'Initials': 'VM', 'LastName': 'Wilson', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Fine', 'Affiliation': 'Clinical Applications and Prevention Branch, National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Whittle', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA; Clement J Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Auchus', 'Affiliation': 'Department of Neurology, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Department of Internal Medicine, University of Utah, School of Medicine, Salt Lake City, UT, USA; Veterans Affairs Salt Lake City Health Care System, Salt Lake City, UT, USA.'}, {'ForeName': 'Dan R', 'Initials': 'DR', 'LastName': 'Berlowitz', 'Affiliation': 'Bedford Veterans Affairs Medical Center, Bedford, MA, USA; Department of Public Health, University of Massachusetts Lowell, Lowell, MA, USA.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Bress', 'Affiliation': 'Department of Population Health Sciences, University of Utah, School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Krousel-Wood', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA; Department of Medicine, Tulane University, New Orleans, LA, USA; Department of Epidemiology, Tulane University, New Orleans, LA, USA; Ochsner Health System, New Orleans, LA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Martindale-Adams', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Eliza C', 'Initials': 'EC', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Dena E', 'Initials': 'DE', 'LastName': 'Rifkin', 'Affiliation': 'Division of Nephrology-Hypertension, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Joni K', 'Initials': 'JK', 'LastName': 'Snyder', 'Affiliation': 'Clinical Applications and Prevention Branch, National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Tamariz', 'Affiliation': 'Miami Veterans Affairs Healthcare System, Miami, FL, USA; Division of Population Health and Computational Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Wolfgram', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA; Clement J Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}, {'ForeName': 'Maryjo L', 'Initials': 'ML', 'LastName': 'Cleveland', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Linda O', 'Initials': 'LO', 'LastName': 'Nichols', 'Affiliation': 'Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, TN, USA.'}, {'ForeName': 'Robert Nick', 'Initials': 'RN', 'LastName': 'Bryan', 'Affiliation': 'Department of Diagnostic Medicine, Dell Medical School, University of Texas, Austin, TX, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Reboussin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30319-7']
1410,33103603,High-Dose Glucagon Has Hemodynamic Effects Regardless of Cardiac Beta-Adrenoceptor Blockade: A Randomized Clinical Trial.,"Background Intravenous high-dose glucagon is a recommended antidote against beta-blocker poisonings, but clinical effects are unclear. We therefore investigated hemodynamic effects and safety of high-dose glucagon with and without concomitant beta-blockade. Methods and Results In a randomized crossover study, 10 healthy men received combinations of esmolol (1.25 mg/kg bolus+0.75 mg/kg/min infusion), glucagon (50 µg/kg), and identical volumes of saline placebo on 5 separate days in random order (saline+saline; esmolol+saline; esmolol+glucagon bolus; saline+glucagon infusion; saline+glucagon bolus). On individual days, esmolol/saline was infused from -15 to 30 minutes. Glucagon/saline was administered from 0 minutes as a 2-minute intravenous bolus or as a 30-minute infusion (same total glucagon dose). End points were hemodynamic and adverse effects of glucagon compared with saline. Compared with saline, glucagon bolus increased mean heart rate by 13.0 beats per minute (95% CI, 8.0-18.0; P <0.001), systolic blood pressure by 15.6 mm Hg (95% CI, 8.0-23.2; P =0.002), diastolic blood pressure by 9.4 mm Hg (95% CI, 6.3-12.6; P <0.001), and cardiac output by 18.0 % (95% CI, 9.7-26.9; P =0.003) at the 5-minute time point on days without beta-blockade. Similar effects of glucagon bolus occurred on days with beta-blockade and between 15 and 30 minutes during infusion. Hemodynamic effects of glucagon thus reflected pharmacologic glucagon plasma concentrations. Glucagon-induced nausea occurred in 80% of participants despite ondansetron pretreatment. Conclusions High-dose glucagon boluses had significant hemodynamic effects regardless of beta-blockade. A glucagon infusion had comparable and apparently longer-lasting effects compared with bolus, indicating that infusion may be preferable to bolus injections. Registration Information URL: https://www.clinicaltrials.gov; Unique identifier: NCT03533179.",2020,"Compared with saline, glucagon bolus increased mean heart rate by 13.0 beats per minute (95% CI, 8.0-18.0; P <0.001), systolic blood pressure by 15.6 mm ",['10 healthy men'],"['saline placebo', 'high-dose glucagon', 'esmolol/saline', 'glucagon', 'Glucagon/saline', 'saline, glucagon', 'Glucagon', 'esmolol (1.25\xa0mg/kg bolus+0.75\xa0mg/kg/min infusion), glucagon', 'ondansetron']","['pharmacologic glucagon plasma concentrations', 'cardiac output', 'mean heart rate', 'hemodynamic and adverse effects of glucagon', 'Glucagon-induced nausea', 'systolic blood pressure', 'diastolic blood pressure']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1320756', 'cui_str': 'mg/kg/min'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}]","[{'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0413602', 'cui_str': 'Glucagon adverse reaction'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",10.0,0.790041,"Compared with saline, glucagon bolus increased mean heart rate by 13.0 beats per minute (95% CI, 8.0-18.0; P <0.001), systolic blood pressure by 15.6 mm ","[{'ForeName': 'Kasper M', 'Initials': 'KM', 'LastName': 'Petersen', 'Affiliation': 'Department of Clinical Pharmacology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Bøgevig', 'Affiliation': 'Department of Clinical Pharmacology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Troels', 'Initials': 'T', 'LastName': 'Riis', 'Affiliation': 'Department of Clinical Pharmacology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Niklas W', 'Initials': 'NW', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Pharmacology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Kim P', 'Initials': 'KP', 'LastName': 'Dalhoff', 'Affiliation': 'Department of Clinical Pharmacology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Medicine Herlev HospitalUniversity of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Tonny S', 'Initials': 'TS', 'LastName': 'Petersen', 'Affiliation': 'Department of Clinical Pharmacology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}, {'ForeName': 'Mikkel B', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Department of Clinical Pharmacology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.016828']
1411,33099836,"The early and late efficacy of single-pass fractional carbondioxide laser, fractional radiofrequency, and their combination in acne scars: A prospective, split-face, single-blinded, controlled clinical study.","We investigated the effectiveness of fractional carbon dioxide laser (FCO 2 ) vs fractional radiofrequency (FRF) and FCO 2 vs FRF plus FCO 2 combination in the treatment of acne scars. Twenty-seven patients were included. Scar severity was scored with ""Echelle d'évaluation clinique des cicatrices d'acné"" (ECCA) by a dermatologist blinded to treatment. FCO 2 and FRF were administered to the right and left halves of the patients' faces, respectively, at the first three visits, once a month. At the fourth visit, FCO 2 was administered to both sides. Last evaluation was performed 6 months after the last treatment. Mean ECCA scores for both face halves decreased gradually at each visit compared with Visit-1; however, the effect size of decrease was higher in the right half of the face and in terms of gender differences was higher in women for both sides that the difference was more pronounced for the FRF side. There was no statistically significant change in the mean VAS patient satisfaction scores in the following visits compared with Visit-2 on both halves (P > .05). Side effects were similar; but lasted longer in the FCO 2 side. Both FCO 2 and FRF are effective treatment methods in the treatment of atrophic acne scars. Combining FCO 2 to FRF improves patient satisfaction. FRF may achieve better results in women compared with men. To our knowledge the study is unique prospective, controlled clinical study comparing the efficacy of FCO 2 and FRF plus FCO 2 combination treatments.",2020,There was no statistically significant change in the mean VAS patient satisfaction scores in the following visits compared to Visit-2 on both halves (p> 0.05).,"['atrophic acne scars', 'acne scars', 'Twenty-seven patients were included']","['single-pass fractional carbondioxide laser, fractional radiofrequency and their combination', 'FCO2 and FRF', 'FRF', 'fractional carbon dioxide laser (FCO2) vs. fractional radiofrequency (FRF) and FCO2 vs. FRF plus FCO2 combination', 'FCO2 and FRF plus FCO2']","['Mean ECCA scores', 'Scar severity', 'Side effects', 'mean VAS patient satisfaction scores']","[{'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0445262', 'cui_str': 'Single pass'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",27.0,0.0323366,There was no statistically significant change in the mean VAS patient satisfaction scores in the following visits compared to Visit-2 on both halves (p> 0.05).,"[{'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Kaçar', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Recep', 'Initials': 'R', 'LastName': 'Dursun', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Necmettin Erbakan University, Konya, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Akbay', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Şule', 'Initials': 'Ş', 'LastName': 'Gökşin', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Pamukkale University, Denizli, Turkey.'}]",Dermatologic therapy,['10.1111/dth.14444']
1412,33106183,"An investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a (the base therapeutic regimen) in moderate to severe COVID-19: A structured summary of a study protocol for a randomized controlled l trial.","OBJECTIVES
We will investigate the effectiveness of high dose Interferon Beta 1a, compared to low dose Interferon Beta 1a (the base therapeutic regimen) in COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed) with moderate to severe disease TRIAL DESIGN: This is a single center, open label, randomized, controlled, 2-arm parallel group (1:1 ratio), clinical trial.
PARTICIPANTS
The eligibility criteria in this study is: age ≥ 18 years, oxygen saturation (SPO2) ≤ 93% or respiratory rate ≥ 24, at least one of the following manifestation: radiation contactless body temperature ≥37.8, Cough, shortness of breath, nasal congestion/ discharge, myalgia/arthralgia, diarrhea/vomiting, headache or fatigue on admission. The onset of the symptoms should be acute (≤ 14 days). The exclusion criteria include refusal to participate, using drugs with potential interaction with lopinavir/ritonavir or interferon-β 1a, blood ALT/AST levels > 5 times the upper limit of normal on laboratory results, pregnant or lactating women, history of alcohol or drug addiction in the past 5 years, the patients who be intubated less than one hours after admission to hospital. This study will be undertaken at the Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences.
INTERVENTION AND COMPARATOR
COVID- 19 confirmed patients (using the RT-PCR test or CT scan) will be randomly assigned to one of two groups. The intervention group (Arms1) will be treated with lopinavir / ritonavir (Kaletra) + high dose Interferon-β 1a (Recigen) and the control group will be treated with lopinavir / ritonavir (Kaletra) + low dose Interferon-β 1a (Recigen) (the base therapeutic regimen). Both groups will receive standard care consisting of the necessary oxygen support, non-invasive, or invasive mechanical ventilation.
MAIN OUTCOMES
Primary outcome: Time to clinical improvement is our primary outcome measure. This is an improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever comes first.
SECONDARY OUTCOMES
mortality from the date of randomization until the last day of the study which will be the day all of the patients have had at least one of the following outcomes: 1) Improvement of two points on a seven-category ordinal scale. 2) Discharge from the hospital 3) Death. Improvement of SPO2 during the hospitalization, duration of hospitalization from date of randomization until the date of hospital discharge or death, whichever comes first. The incidence of new mechanical ventilation uses from the date of randomization until the last day of the study and the duration of it will be extracted. Please note that we are trying to add further secondary outcomes and this section of the protocol is still evolving.
RANDOMIZATION
Eligible patients with confirmed SARS-Cov-2 infections will be randomly assigned in a 1:1 ratio to two therapeutic arms using permuted, block-randomization to balance the number of patients allocated to each group. The permuted block (three or six patients per block) randomization sequence will be generated, using Package 'randomizeR' in R software version 3.6.1. and placed in individual sealed and opaque envelopes by the statistician. The investigator will enroll the patients and only then open envelopes to assign patients to the different treatment groups. This method of allocation concealment will result in minimum selection and confounding biases.
BLINDING (MASKING)
The present research is open-label (no masking) of patients and health care professionals who are undertaking outcome assessment of the primary outcome - time to clinical improvement.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
Of the 100 patients randomised, 50 patients will be assigned to receive high dose Interferon beta-1a plus lopinavir/ritonavir (Kaletra), 50 patients will be assigned to receive low dose Interferon beta 1a plus lopinavir/ritonavir (Kaletra).
TRIAL STATUS
Protocol version 1.2.1. Recruitment is finished, the start date of recruitment was on August 20 th 2020, and the end date was on September 4 th 2020. Last point of data collection will be the last day on which all of the 100 participants have had an outcome of clinical improvement or death, up to 14th days after hospitalization.
TRIAL REGISTRATION
This study was registered with National Institutes of Health Clinical trials ( www.clinicaltrials.gov ; identification number NCT04521400, https://clinicaltrials.gov/ct2/show/NCT04521400 , registered August 18, 2020 and first available online August 20, 2020).
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Improvement of SPO2 during the hospitalization, duration of hospitalization from date of randomization until the date of hospital discharge or death, whichever comes first.","['100 patients randomised', 'registered with National Institutes of Health Clinical trials ( www.clinicaltrials.gov ; identification number NCT04521400, https://clinicaltrials.gov/ct2/show/NCT04521400 , registered August 18, 2020 and first available online August 20, 2020', 'Eligible patients with confirmed SARS-Cov-2 infections', 'Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences', 'moderate to severe COVID-19', 'COVID-19 Confirmed Cases', ' 5 times the upper limit of normal on laboratory results, pregnant or lactating women, history of alcohol or drug addiction in the past 5 years, the patients who be intubated less than one hours after admission to hospital', 'The eligibility criteria in this study is: age ≥ 18 years, oxygen saturation (SPO2) ≤ 93% or respiratory rate ≥ 24, at least one of the following manifestation: radiation contactless body temperature ≥37.8, Cough, shortness of breath, nasal congestion/ discharge, myalgia/arthralgia, diarrhea/vomiting, headache or fatigue on admission', '50 patients']","['lopinavir/ritonavir or interferon-β 1a, blood ALT/AST levels', 'lopinavir / ritonavir (Kaletra) + high dose Interferon-β 1a (Recigen) and the control group will be treated with lopinavir / ritonavir (Kaletra) + low dose Interferon-β 1a (Recigen', 'Interferon beta-1a plus lopinavir/ritonavir (Kaletra', 'standard care consisting of the necessary oxygen support, non-invasive, or invasive mechanical ventilation', 'low dose Interferon beta 1a plus lopinavir/ritonavir (Kaletra']",[],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1300638', 'cui_str': 'Identification number'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1510472', 'cui_str': 'Drug dependence'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0457453', 'cui_str': 'On admission'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0939357', 'cui_str': 'Kaletra'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]",[],50.0,0.151389,"Improvement of SPO2 during the hospitalization, duration of hospitalization from date of randomization until the date of hospital discharge or death, whichever comes first.","[{'ForeName': 'Ilad', 'Initials': 'I', 'LastName': 'Alavi Darazam', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. ilad13@yahoo.com.'}, {'ForeName': 'Firouze', 'Initials': 'F', 'LastName': 'Hatami', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Mahdi', 'Initials': 'MM', 'LastName': 'Rabiei', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamad Amin', 'Initials': 'MA', 'LastName': 'Pourhoseingholi', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Moradi', 'Affiliation': 'Student Research Committee, Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Shokouhi', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Hajesmaeili', 'Affiliation': 'Anesthesiology Research Center Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Minoosh', 'Initials': 'M', 'LastName': 'Shabani', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Sina Naghibi', 'Initials': 'SSN', 'LastName': 'Irvani', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Trials,['10.1186/s13063-020-04812-2']
1413,33107132,Phase 1 trial for treatment of COVID-19 patients with pulmonary fibrosis using hESC-IMRCs.,,2020,,['COVID-19 patients with pulmonary fibrosis using hESC-IMRCs'],[],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}]",[],[],,0.0164588,,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Wuhan Jinyintan Hospital, Wuhan, China.'}, {'ForeName': 'Yuanqing', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Tianda', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Institute for Stem Cell and Regeneration, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Zhongwen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Gao', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Baojie', 'Initials': 'B', 'LastName': 'Guo', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hao', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xianguang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Wuhan Jinyintan Hospital, Wuhan, China.'}, {'ForeName': 'Baoyang', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}]",Cell proliferation,['10.1111/cpr.12944']
1414,33104444,Surgical prehabilitation using mobile health coaching in patients with obesity: A pilot study.,"Many patients spend months waiting for elective procedures, and many have significant modifiable risk factors that could contribute to an increased risk of perioperative morbidity and mortality. The minimal direct contact that usually occurs with healthcare professionals during this period represents a missed opportunity to improve patient health and surgical outcomes. Patients with obesity comprise a large proportion of the surgical workload but are under-represented in prehabilitation studies. Our study piloted a mobile phone based, multidisciplinary, prehabilitation programme for patients with obesity awaiting elective surgery. A total of 22 participants were recruited via the Wollongong Hospital pre-admissions clinic in New South Wales, Australia, and 18 completed the study. All received the study intervention of four text messages per week for six months. Questionnaires addressing the self-reported outcome measures were performed at the start and completion of the study. Forty percent of participants lost weight and 40% of smokers decreased their cigarette intake over the study. Sixty percent reported an overall improved health score. Over 80% of patients found the programme effective for themselves, and all recommended that it be made available to other patients. The cost was A$1.20 per patient per month. Our study showed improvement in some of the risk factors for perioperative morbidity and mortality. With improved methods to increase enrolment, our overall impression is that text message-based mobile health prehabilitation may be a feasible, cost-effective and worthwhile intervention for patients with obesity.",2020,"Over 80% of patients found the programme effective for themselves, and all recommended that it be made available to other patients.","['22 participants were recruited via the Wollongong Hospital pre-admissions clinic in New South Wales, Australia, and 18 completed the study', 'Patients with obesity comprise a large proportion of the surgical workload but are under-represented in prehabilitation studies', 'patients with obesity awaiting elective surgery', 'patients with obesity']",['Surgical prehabilitation using mobile health coaching'],"['cigarette intake', 'health score', 'perioperative morbidity and mortality']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0559269', 'cui_str': 'Pre-admission'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",22.0,0.050224,"Over 80% of patients found the programme effective for themselves, and all recommended that it be made available to other patients.","[{'ForeName': 'Kasia', 'Initials': 'K', 'LastName': 'Kulinski', 'Affiliation': 'Department of Anaesthesia, Prince of Wales Hospital, Randwick, Australia.'}, {'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Smith', 'Affiliation': 'Department of Anaesthesia, Wollongong Hospital, Wollongong, Australia.'}]",Anaesthesia and intensive care,['10.1177/0310057X20947731']
1415,33112463,"Efficacy and safety of a novel herbal solution for the treatment of androgenetic alopecia and comparison with 5% minoxidil: A double-blind, randomized controlled trial study.","FDA-approved drugs for the most common type of hair loss, androgenetic alopecia (AGA), present many side effects and disadvantages. However, herbal compounds are characterized by patient compliance, fewer side effects, and several mechanisms of action. The present study set to evaluate the effectiveness and safety of the topical herbal solution and to compare it with 5% minoxidil in men with AGA. A randomized, double-blind controlled trial was conducted from 28 November 2018 to 2 September 2019, in Sina Hospital, Tabriz, Iran. 24 healthy males (mean [SD] age 33.04 [5.81]) with mild to moderate AGA were selected from 44 volunteer participants. Participants were randomly assigned (1:1) into two groups. They received 1 ml of topical solutions at morning and evening intervals for 9 months. Primary outcomes consisted of measured hair diameters at baseline and repeated at weeks 12, 24, and 36. Furthermore, hair density was measured at baseline and week 36. The MTS + THS group was significantly superior to the MTS group after 36 weeks of therapy in the hair diameter improvement. At week 36, the mean hair diameter of the MTS + THS group significantly increased compared to the MTS group (P = .001). Hair density increased in both groups; however, only in the MTS + THS group, it was significant (P < .05). The findings established that the topical herbal solution has significant influence on patients with AGA and improvement of their quality of life. This solution can be considered a significant step towards the prevention and treatment of AGA. clinicaltrials.gov Identifier: NCT03753113.",2020,The MTS+THS group was significantly superior to the MTS group after 36 weeks of therapy in the hair diameter improvement.,"['November 28, 2018, to September 2, 2019, in Sina Hospital, Tabriz, Iran', 'men with AGA', '24 healthy males (mean (SD) age 33.04 (5.81)) with mild to moderate AGA were selected from 44 volunteer participants']","['novel herbal solution', 'topical herbal solution', 'MTS', 'minoxidil', 'MTS + THS']","['mean hair diameter', 'Furthermore, hair density', 'measured hair diameters', 'effectiveness and safety', 'Efficacy and safety', 'quality of life', 'Hair density']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0796074', 'cui_str': 'Deafness-dystonia-optic neuronopathy syndrome'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",24.0,0.29193,The MTS+THS group was significantly superior to the MTS group after 36 weeks of therapy in the hair diameter improvement.,"[{'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Masoud', 'Affiliation': 'Faculty of Pharmacy, Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamideh Azimi', 'Initials': 'HA', 'LastName': 'Alamdari', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Solmaz', 'Initials': 'S', 'LastName': 'Asnaashari', 'Affiliation': 'Biotechnology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Shokri', 'Affiliation': 'Faculty of Pharmacy, Biotechnology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Javadzadeh', 'Affiliation': 'Faculty of Pharmacy, Biotechnology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Dermatologic therapy,['10.1111/dth.14467']
1416,33108690,"Preventive interventions for children in organized team sport tackling aggression: Results from the pilot evaluation of ""Fairplayer.Sport"".","Current reviews revealed that there is a lack of effective programs and valuable effectiveness studies related to prevention of aggressive behavior and fostering of social competence in early adolescents participating in organized team sports (e.g., ball sports, such as soccer). Using a randomized controlled design, the present pilot study presents first results regarding the effectiveness of the preventive intervention program ""Fairplayer.Sport"" that was implemented with preadolescent soccer players (N = 145 preadolescents; aged 9-14 years; mean = 12.2 years) in organized team sport (13 soccer teams). Results revealed a reduction of aggressive behavior in the intervention groups compared to waiting-control groups (small effect size). This effect remained stable 3 months after program implementation. Implications for planning and implementing preventive intervention programs are discussed.",2020,Results revealed a reduction of aggressive behavior in the intervention groups compared to waiting-control groups (small effect size).,"['children in organized team sport tackling aggression', 'preadolescent soccer players (N = 145 preadolescents', 'aged 9-14 years; mean = 12.2 years) in organized team sport (13 soccer teams']",[],['aggressive behavior'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",[],"[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]",,0.0208526,Results revealed a reduction of aggressive behavior in the intervention groups compared to waiting-control groups (small effect size).,"[{'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Scheithauer', 'Affiliation': 'Department of Education and Psychology, Freie Universität Berlin, Habelschwerdter Allee 45, Berlin, 14195, Germany.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Leppin', 'Affiliation': 'Department of Psychology, Philipps-Universität Marburg, Gutenbergstraße 18, Marburg, 35032, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hess', 'Affiliation': 'Applied Developmental and Social Psychology, German University of Health and Sports, Franklinstraße 28-29, Berlin, 10587, Germany.'}]",New directions for child and adolescent development,['10.1002/cad.20380']
1417,33112720,"The alliance mediates outcome in cognitive-behavioral therapy for social anxiety disorder, but not in attention bias modification.","Objective: The aim of the current study was to examine changes in the therapeutic alliance and its role as a mediator of treatment outcome in cognitive behavioral therapy (CBT) for social anxiety disorder (SAD) compared to attention bias modification (ABM). Method: Patients were randomized to 16-20 sessions of CBT (n = 33) or 8 sessions of ABM (n = 17). Patient-rated alliance and self-reported social anxiety were measured weekly and evaluator-rated social anxiety was measured monthly. Results: Early alliance predicted greater subsequent anxiety reduction in CBT but not in ABM. The alliance increased and weekly improvements in alliance predicted weekly contemporaneous and subsequent decreases in anxiety only in CBT. Decreases in anxiety did not predict subsequent improvements in alliance. Both treatments were effective in reducing anxiety, but treatment effects were mediated by stronger early alliance and stronger cross-lagged effects of alliance on outcome in CBT compared to ABM. Conclusions: The results highlight the importance of the alliance in CBT for SAD. Further studies should examine the role of alliance alongside additional mediators to better understand differential mechanisms in CBT and ABM.",2020,"Both treatments were effective in reducing anxiety, but treatment effects were mediated by stronger early alliance and stronger cross-lagged effects of alliance on outcome in CBT compared to ABM. ",['social anxiety disorder (SAD'],"['CBT', 'ABM', 'cognitive behavioral therapy (CBT', 'cognitive-behavioral therapy']","['anxiety', 'social anxiety', 'subsequent anxiety reduction', 'Patient-rated alliance and self-reported social anxiety']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",,0.0198017,"Both treatments were effective in reducing anxiety, but treatment effects were mediated by stronger early alliance and stronger cross-lagged effects of alliance on outcome in CBT compared to ABM. ","[{'ForeName': 'Yogev', 'Initials': 'Y', 'LastName': 'Kivity', 'Affiliation': ''}, {'ForeName': 'Asher Y', 'Initials': 'AY', 'LastName': 'Strauss', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Elizur', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Huppert', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1836423']
1418,33115487,Immersive Virtual Environments and Wearable Haptic Devices in rehabilitation of children with neuromotor impairments: a single-blind randomized controlled crossover pilot study.,"BACKGROUND
The past decade has seen the emergence of rehabilitation treatments using virtual reality. One of the advantages in using this technology is the potential to create positive motivation, by means of engaging environments and tasks shaped in the form of serious games. The aim of this study is to determine the efficacy of immersive Virtual Environments and weaRable hAptic devices (VERA) for rehabilitation of upper limb in children with Cerebral Palsy (CP) and Developmental Dyspraxia (DD).
METHODS
A two period cross-over design was adopted for determining the differences between the proposed therapy and a conventional treatment. Eight children were randomized into two groups: one group received the VERA treatment in the first period and the manual therapy in the second period, and viceversa for the other group. Children were assessed at the beginning and the end of each period through both the Nine Hole Peg Test (9-HPT, primary outcome) and Kinesiological Measurements obtained during the performing of similar tasks in a real setting scenario (secondary outcomes).
RESULTS
All subjects, not depending from which group they come from, significantly improved in both the performance of the 9-HPT and in the parameters of the kinesiological measurements (movement error and smoothness). No statistically significant differences have been found between the two groups.
CONCLUSIONS
These findings suggest that immersive VE and wearable haptic devices is a viable alternative to conventional therapy for improving upper extremity function in children with neuromotor impairments. Trial registration ClinicalTrials, NCT03353623. Registered 27 November 2017-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03353623.",2020,"All subjects, not depending from which group they come from, significantly improved in both the performance of the 9-HPT and in the parameters of the kinesiological measurements (movement error and smoothness).","['children with Cerebral Palsy (CP) and Developmental Dyspraxia (DD', 'children with neuromotor impairments', 'Eight children']","['immersive Virtual Environments and weaRable hAptic devices (VERA', 'VERA', 'immersive VE and wearable haptic devices', 'Immersive Virtual Environments and Wearable Haptic Devices']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0011757', 'cui_str': 'Developmental coordination disorder'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",[],8.0,0.052256,"All subjects, not depending from which group they come from, significantly improved in both the performance of the 9-HPT and in the parameters of the kinesiological measurements (movement error and smoothness).","[{'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Bortone', 'Affiliation': 'Institute of Clinical Physiology (IFC), National Research Council (CNR), Pisa, Italy. ilariabortone@gmail.com.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Barsotti', 'Affiliation': ""PERCRO Laboratory, Scuola Superiore Sant'Anna, Pisa, Italy.""}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Leonardis', 'Affiliation': ""PERCRO Laboratory, Scuola Superiore Sant'Anna, Pisa, Italy.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Crecchi', 'Affiliation': 'Unit of Developmental Neurorehabilitation, Maternal and Child Department, Pisa University Hospital, Pisa, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tozzini', 'Affiliation': 'Unit of Developmental Neurorehabilitation, Maternal and Child Department, Pisa University Hospital, Pisa, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Bonfiglio', 'Affiliation': 'Unit of Developmental Neurorehabilitation, Maternal and Child Department, Pisa University Hospital, Pisa, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Frisoli', 'Affiliation': ""PERCRO Laboratory, Scuola Superiore Sant'Anna, Pisa, Italy.""}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00771-6']
1419,33116073,Influence of Scapula Training Exercises on Shoulder Joint Function After Surgery for Rotator Cuff Injury.,"BACKGROUND The aim of this study was to assess the clinical effectiveness of scapula training exercises on shoulder function after surgery for rotator cuff injury. MATERIAL AND METHODS Forty-six patients with rotator cuff injury after surgery were randomized into the experiment group or control group. Both groups were treated with conventional therapeutic exercise and physical therapy, and scapular training exercise was added to the experiment group. Patient status was evaluated by Constant-Murley scale (CMS), visual analogue scale (VAS), and the active range of motion (ROM) of the shoulder before and after 6 weeks and 12 weeks of treatment. RESULTS After 6 weeks and 12 weeks of treatment, all evaluations of the 2 groups were significantly improved as compared with those before treatment (P0.05). After 12 weeks of treatment, all items in the experimental group were significantly improved compared to the control group (P<0.05). CONCLUSIONS The combination of conventional rehabilitation interventions and scapular training exercise were an effective treatment of the shoulder dysfunction. Moreover, increased Scapula training exercise had better effect on the improvement of shoulder function.",2020,"After 6 weeks and 12 weeks of treatment, all evaluations of the 2 groups were significantly improved as compared with those before treatment (P0.05).","['Forty-six patients with rotator cuff injury after surgery', 'rotator cuff injury']","['scapula training exercises', 'Scapula Training Exercises', 'conventional therapeutic exercise and physical therapy, and scapular training exercise', 'conventional rehabilitation interventions and scapular training exercise']","['Shoulder Joint Function', 'shoulder function', 'Constant-Murley scale (CMS), visual analogue scale (VAS), and the active range of motion (ROM) of the shoulder']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0851122', 'cui_str': 'Injury of rotator cuff'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0036277', 'cui_str': 'Bone structure of scapula'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",46.0,0.0186742,"After 6 weeks and 12 weeks of treatment, all evaluations of the 2 groups were significantly improved as compared with those before treatment (P0.05).","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, Xuzhou Central Hospital/The Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Jingjie', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Rehabilitation Medicine, Xuzhou Central Hospital/The Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, Xuzhou Central Hospital/The Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Xiufang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, Xuzhou Central Hospital/The Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Xuzhou Central Hospital/The Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Xuzhou Central Hospital/The Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.925758']
1420,33116094,Effect of Infant Massage in Reduction of Neonatal Jaundice.,"Infant massage is a traditional practice for newborns in some parts of the world; its beneficial effects in reduction of jaundice in the neonates are a matter of investigation. This study aims to find out the effects of massage therapy in term neonates with neonatal jaundice receiving phototherapy compared with a control group. This randomized controlled trial (RCT) includes total 100 term newborns evenly divided into the massage group and control group after obtaining informed consent and was conducted in the Neonatal ward of the Sher-e-Bangla Medical College, Barisal, Bangladesh from 1st January 2018 to 30th June 2018. The massage group received both massage therapy and phototherapy for neonatal jaundice whereas the control group received only phototherapy. Data were collected and analyzed and results were prepared by student's 't' test for continuous variables and chi-square test for categorical variables and statistical significance was found if p value <0.05. Both the massage group and control group were comparable in birth weight, weight at admission, gestational age, sex ratio, mode of delivery and hospital stay (p>0.05). The defecation frequency was significantly more in massage group than control group and serum bilirubin levels were significantly lower in massage group than control group on day 3 onward (p<0.05). Infant massage is a safe, effective and economic practice, which can be an adjunct to phototherapy in the management of neonatal jaundice.",2020,"Both the massage group and control group were comparable in birth weight, weight at admission, gestational age, sex ratio, mode of delivery and hospital stay (p>0.05).","['term neonates with neonatal jaundice receiving phototherapy compared with a control group', 'total 100 term newborns evenly divided into the massage group and control group after obtaining informed consent and was conducted in the Neonatal ward of the Sher-e-Bangla Medical College, Barisal, Bangladesh from 1st January 2018 to 30th June 2018']","['massage therapy', 'control group received only phototherapy', 'Infant Massage', 'massage therapy and phototherapy', 'Infant massage']","['Neonatal Jaundice', 'serum bilirubin levels', 'defecation frequency']","[{'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0022353', 'cui_str': 'Neonatal jaundice'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0004981', 'cui_str': 'Bengali language'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0205435', 'cui_str': 'First'}]","[{'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0695595', 'cui_str': 'Infant massage'}]","[{'cui': 'C0022353', 'cui_str': 'Neonatal jaundice'}, {'cui': 'C0428441', 'cui_str': 'Serum bilirubin measurement'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",100.0,0.012086,"Both the massage group and control group were comparable in birth weight, weight at admission, gestational age, sex ratio, mode of delivery and hospital stay (p>0.05).","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Amin', 'Affiliation': 'Dr Tahsinul Amin, Associate Professor, Department of Neonatology, Sher-e-Bangla Medical College, Barisal, Bangladesh; E-mail: tahsinul_amin@yahoo.com.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Nur', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[]
1421,33116101,The Additive Effects of Midazolam in Sub Arachnoid Block in Elective Caesarian Section: A Randomized Control Trial.,"The incidence of visceral pain among caesarean section can be as high as 50% in sub arachnoid block (SAB) in spite adequate sensory block, which requires conversion to general anesthesia. Different types of adjuvant have been used to augment the effect of local anesthetics but their use is limited due to adverse effects. The effect of intrathecal midazolam along with hyperbaric bupivacaine in sub arachnoid block is less known. So this randomized, double blind study was conducted to evaluate the additive effect of 0.4ml midazolam to 0.5% 3ml bupivacaine on sub arachnoid block in scheduled elective caesarean section. This study demonstrated that the addition of intrathecal 0.4ml midazolam to spinal 0.5% bupivacaine kept all the characteristics of block unaffected, furthermore pain score VAS 3.4±1.3 in Group A and 1.8±1.22 in Group B which is statistically significant, the requirement of intraoperative analgesia and also increased the duration of postoperative analgesia that is 130.3±5.4 minute in Group A, 265.1±3.6 minute in Group B and also statistically significant. Therefore addition of 2.0mg midazolam with 0.5% bupivacaine significantly reduces the VAS score, reduces the intraoperative visceral pain and need of analgesia.",2020,"Therefore addition of 2.0mg midazolam with 0.5% bupivacaine significantly reduces the VAS score, reduces the intraoperative visceral pain and need of analgesia.","['scheduled elective caesarean section', 'Elective Caesarian Section']","['bupivacaine', 'hyperbaric bupivacaine', 'intrathecal 0.4ml midazolam', 'intrathecal midazolam', 'midazolam', 'Midazolam']","['furthermore pain score VAS', 'duration of postoperative analgesia', 'VAS score', 'visceral pain', 'intraoperative analgesia', 'intraoperative visceral pain and need of analgesia']","[{'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234245', 'cui_str': 'Visceral pain'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]",,0.39745,"Therefore addition of 2.0mg midazolam with 0.5% bupivacaine significantly reduces the VAS score, reduces the intraoperative visceral pain and need of analgesia.","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Alam', 'Affiliation': 'Professor Dr ABM Muksudul Alam, Professor of Anaesthesiology, Department of Anaesthesiology, Shaheed Suhrawardy Medical College (SSMC), Dhaka, Bangladesh.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Deeba', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Matin', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ivy', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Begum', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[]
1422,33124591,"A Randomized Controlled Trial to Compare the Efficacy, Safety and Tolerability of Asenapine versus Olanzapine in Management of Schizophrenia.","Objective
: Schizophrenia is a serious disease characterized by impairment in the perception or expression of reality, leading to occupational and social dysfunction. The use of antipsychotic medication is now universal in the first-line treatment of schizophrenia. This study was undertaken to compare the efficacy of asenapine with a standard atypical antipsychotic, olanzapine in treating this disease.
Methods
It was designed as a single blind, randomized, controlled, parallel group, single centre Phase IV trial of a newer atypical antipsychotic, asenapine versus existing standard atypical antipsychotic, olanzapine. Total 80 subjects were enrolled as per eligibility criteria.Each recruited subject received daily treatment with the trial medication (Olanzapine 10 mg or Asenapine 10 mg daily) for duration of 12 weeks. BPRS, CGI-S, CGI-I, Laboratory parameters and compliance was assessed and analyzed. Continuous variables were compared by t test and non-parametric data was analyzed by Mann-Whitney U test and Wilcoxon signed rank test. Likely categorical variables were analyzed by chi-square test or Fisher's exact test, as appropriate.
Results
The duration of schizophrenia at presentation was comparable in both the treatment groups. There was significant reduction of BPRS score between any two visits of each treatment groups. The decline in CGI-S and CGI-I scores was statistically significant ( p < 0.001) when compared between visits of any of the both treatment arms. Adherence to treatment was excellent for all patients.
Conclusion
Newer atypical antipsychotic asenapine is more effective than standard olanzapine in reducing the symptoms of schizophrenia in this study and further larger studies are to be done.",2020,The decline in CGI-S and CGI-I scores was statistically significant ( p < 0.001) when compared between visits of any of the both treatment arms.,['Total 80 subjects were enrolled as per eligibility criteria'],"['olanzapine', 'trial medication (Olanzapine 10 mg or Asenapine', 'Asenapine versus Olanzapine', 'atypical antipsychotic, asenapine versus existing standard atypical antipsychotic, olanzapine', 'asenapine', 'antipsychotic medication']","['BPRS score', 'Efficacy, Safety and Tolerability', 'decline in CGI-S and CGI-I scores', 'BPRS, CGI-S, CGI', 'duration of schizophrenia at presentation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0988260', 'cui_str': 'olanzapine 10 MG'}, {'cui': 'C2000088', 'cui_str': 'Asenapine'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]",80.0,0.0257721,The decline in CGI-S and CGI-I scores was statistically significant ( p < 0.001) when compared between visits of any of the both treatment arms.,"[{'ForeName': 'Arpita', 'Initials': 'A', 'LastName': 'Maitra', 'Affiliation': 'Department of Pharmacology, Burdwan Medical College, Burdwan, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Bhattacharyya', 'Affiliation': 'Department of Pharmacology, RG Kar Medical College, India.'}, {'ForeName': 'Sabyasachi', 'Initials': 'S', 'LastName': 'Mukhopadhyay', 'Affiliation': 'Department of Neonatology, AMRI Hospital, Kolkata, India.'}, {'ForeName': 'Asim Kumar', 'Initials': 'AK', 'LastName': 'Mallick', 'Affiliation': 'Department of Psychiatry, Burdwan Medical College, Burdwan, India.'}, {'ForeName': 'Supreeti', 'Initials': 'S', 'LastName': 'Biswas', 'Affiliation': 'Department of Pharmacology, Burdwan Medical College, Burdwan, India.'}, {'ForeName': 'Om Prakash', 'Initials': 'OP', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry, Burdwan Medical College, Burdwan, India.'}]",Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology,['10.9758/cpn.2020.18.4.587']
1423,33124599,"Corrigendum: A Pharmacogenomic-based Antidepressant Treatment for Patients with Major Depressive Disorder: Results from an 8-week, Randomized, Single-blinded Clinical Trial.",,2020,,['Patients with Major Depressive Disorder'],['Pharmacogenomic-based Antidepressant Treatment'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C1138555', 'cui_str': 'Pharmacogenomic specialist'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0941954,,"[{'ForeName': 'Changsu', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Department of Psychiatry, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sheng-Min', 'Initials': 'SM', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Won-Myong', 'Initials': 'WM', 'LastName': 'Bahk', 'Affiliation': 'Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Soo-Jung', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Ashwin A', 'Initials': 'AA', 'LastName': 'Patkar', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Prakash S', 'Initials': 'PS', 'LastName': 'Masand', 'Affiliation': 'Global Medical Education, New York, NY, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mandelli', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Psychiatric Section, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Chi-Un', 'Initials': 'CU', 'LastName': 'Pae', 'Affiliation': 'Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Serretti', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Psychiatric Section, University of Bologna, Bologna, Italy.'}]",Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology,['10.9758/cpn.2020.18.4.641']
1424,33125080,Relationship of IGF-1 and IGF Binding Proteins to Disease Severity and Glycemia in Non-Alcoholic Fatty Liver Disease.,"CONTEXT
GH and IGF-1 help regulate hepatic glucose and lipid metabolism, and reductions in these hormones may contribute to development of nonalcoholic fatty liver disease (NAFLD).
OBJECTIVE
To assess relationships between hepatic expression of IGF1 and IGF binding proteins (IGFBPs) and measures of glycemia and liver disease in adults with NAFLD. Secondarily to assess effects of GH releasing hormone (GHRH) on circulating IGFBPs.
DESIGN
Analysis of data from a randomized clinical trial of GHRH.
SETTING
Two US academic medical centers.
PARTICIPANTS
61 men and women 18-70yo with HIV-infection, ≥5% hepatic fat fraction, including 39 with RNA-Seq data from liver biopsy.
MAIN OUTCOME MEASURES
Hepatic steatosis, inflammation, and fibrosis by histopathology and measures of glucose homeostasis.
RESULTS
Hepatic IGF1 mRNA was significantly lower in individuals with higher steatosis and NAFLD Activity Score (NAS) and was inversely related to glucose parameters, independent of circulating IGF-1. Among the IGFBP's, IGFBP2 and IGFBP4 were lower and IGFBP6 and IGFBP7 (also known as IGFBP-related protein 1) higher with increasing steatosis. Hepatic IGFBP6 and IGFBP7 mRNA were positively associated with NAS. IGFBP7 mRNA increased with increasing fibrosis. Hepatic IGFBP1 mRNA was inversely associated with glycemia and insulin resistance, with opposite relationships present for IGFBP3 and IGFBP7. GHRH increased circulating IGFBP-1 and IGFBP-3, but decreased IGFBP-2 and IGFBP-6.
CONCLUSIONS
These data demonstrate novel relationships of IGF-1 and IGFBPs with NAFLD severity and glucose control, with divergent roles seen for different IGFBPs. Moreover, the data provide new information on the complex effects of GHRH on IGFBPs.",2020,"RESULTS
Hepatic IGF1 mRNA was significantly lower in individuals with higher steatosis and NAFLD Activity Score (NAS) and was inversely related to glucose parameters, independent of circulating IGF-1.","['61 men and women 18-70yo with HIV-infection, ≥5% hepatic fat fraction, including 39 with RNA-Seq data from liver biopsy', 'adults with NAFLD', 'Two US academic medical centers']",['GH releasing hormone (GHRH'],"['IGFBP6 and IGFBP7', 'IGFBP7 mRNA', 'glycemia and insulin resistance', 'IGFBP-2 and IGFBP-6', 'Hepatic IGFBP1 mRNA', 'Hepatic steatosis, inflammation, and fibrosis by histopathology and measures of glucose homeostasis', 'IGFBP2 and IGFBP4', 'NAFLD Activity Score (NAS', 'Hepatic IGF1 mRNA', 'Hepatic IGFBP6 and IGFBP7 mRNA', 'circulating IGFBP-1 and IGFBP-3']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4086963', 'cui_str': 'Complete Transcriptome Sequencing'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0123257', 'cui_str': 'Insulin-like growth factor binding protein 2'}, {'cui': 'C0169975', 'cui_str': 'IGFBP-6'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0071189', 'cui_str': 'IGFBP1 protein, human'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0243140', 'cui_str': 'histopathology'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C1295163', 'cui_str': 'Insulin-like growth factor binding protein 2 measurement'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0202220', 'cui_str': 'Somatomedin-C measurement'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}]",61.0,0.0286818,"RESULTS
Hepatic IGF1 mRNA was significantly lower in individuals with higher steatosis and NAFLD Activity Score (NAS) and was inversely related to glucose parameters, independent of circulating IGF-1.","[{'ForeName': 'Takara L', 'Initials': 'TL', 'LastName': 'Stanley', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Lindsay T', 'Initials': 'LT', 'LastName': 'Fourman', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Zheng', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Colin M', 'Initials': 'CM', 'LastName': 'McClure', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Meghan N', 'Initials': 'MN', 'LastName': 'Feldpausch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Torriani', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Corey', 'Affiliation': 'Liver Center, Gastroenterology Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Chung', 'Affiliation': 'Liver Center, Gastroenterology Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kleiner', 'Affiliation': 'Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Hadigan', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa792']
1425,33128903,Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study.,"BACKGROUND
Fostemsavir, a prodrug of the first-in-class attachment inhibitor, temsavir, is indicated for heavily treatment-experienced individuals with multidrug-resistant HIV-1. We previously reported superior efficacy of fostemsavir versus placebo in the randomised cohort of the BRIGHTE study after 8-day functional monotherapy (primary endpoint); here we report planned interim analyses through week 96.
METHODS
BRIGHTE (NCT02362503) is an ongoing multicentre, two-cohort, phase 3 trial, done at 108 centres in 22 countries. We enrolled heavily treatment-experienced adults (≥18 years) failing antiretroviral therapy (HIV-1 RNA ≥400 copies per mL) into two cohorts: the randomised cohort, in which patients with one or two fully active antiretrovirals remaining received oral fostemsavir (600 mg twice a day) or placebo in combination with their failing regimen for 8 days, followed by fostemsavir plus optimised background therapy; or the non-randomised cohort, in which patients with no remaining antiretroviral options received oral fostemsavir (600 mg twice a day) plus optimised background therapy from day 1. Endpoints for the week 96 interim analyses included the proportions of participants with plasma HIV-1 RNA of less than 40 copies per mL, changes from baseline in CD4 cell counts, and the frequency of adverse events, adverse events leading to discontinuation, and deaths. The intention-to-treat exposed population and the safety population both included all participants who received at least one dose of study treatment. The response rates (proportion of participants with HIV-1 RNA <40 copies per mL) in the intention-to-treat exposed population were calculated via snapshot analysis at weeks 24, 48, and 96.
FINDINGS
Between Feb 23, 2015, and Aug 11, 2016, 371 participants were enrolled and treated, of which 272 participants were in the randomised cohort and 99 in the non-randomised cohort. 320 (86%) of 371 reported a history of AIDS. In the randomised cohort, rates of virological suppression (HIV-1 RNA <40 copies per mL) increased from 53% (144 of 272) at week 24 to 60% (163 of 272) at week 96. Response rates in the non-randomised cohort were 37% (37 of 99) at week 24 and week 96. Mean increases in CD4 counts from baseline at week 96 were 205 cells per μL (SD 191) in the randomised cohort and 119 cells per μL (202) in the non-randomised cohort. Mean CD4/CD8 ratio increased from 0·20 at baseline to 0·44 at week 96 in the randomised cohort. Few adverse events led to discontinuation (26 [7%] of 371). 12 (4%) of 272 people in the randomised cohort and 17 (17%) of 99 in the non-randomised cohort died; the median baseline CD4 count for participants who died was 11 cells per μL.
INTERPRETATION
In heavily treatment-experienced individuals with advanced HIV-1 disease and limited treatment options, fostemsavir-based antiretroviral regimens were generally well tolerated and showed a distinctive trend of increasing virological and immunological response rates through 96 weeks; these findings support fostemsavir as a treatment option for this vulnerable population.
FUNDING
ViiV Healthcare.",2020,"In the randomised cohort, rates of virological suppression (HIV-1 RNA <40 copies per mL) increased from 53% (144 of 272) at week 24 to 60% (163 of 272) at week 96.","['heavily treatment-experienced individuals', 'heavily treatment-experienced individuals with multidrug-resistant HIV-1', '108 centres in 22 countries', 'enrolled heavily treatment-experienced adults (≥18 years) failing antiretroviral therapy (HIV-1 RNA ≥400 copies per mL) into two cohorts: the randomised cohort, in which patients with one or two fully active antiretrovirals remaining received', 'Between Feb 23, 2015, and Aug 11, 2016, 371 participants were enrolled and treated, of which 272 participants were in the randomised cohort and 99 in the non-randomised cohort', '320 (86%) of 371 reported a history of AIDS']","['HIV-1 attachment inhibitor prodrug fostemsavir', 'placebo in combination with their failing regimen for 8 days, followed by fostemsavir plus optimised background therapy', 'oral fostemsavir', 'oral fostemsavir (600 mg twice a day) plus optimised background therapy', 'fostemsavir versus placebo']","['CD4 counts', 'response rates', 'Safety and efficacy', 'Response rates', 'Mean CD4/CD8 ratio', 'median baseline CD4 count', 'proportions of participants with plasma HIV-1 RNA', 'rates of virological suppression', 'CD4 cell counts', 'frequency of adverse events, adverse events leading to discontinuation, and deaths']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0033262', 'cui_str': 'Drug Precursors'}, {'cui': 'C4519220', 'cui_str': 'fostemsavir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",272.0,0.540505,"In the randomised cohort, rates of virological suppression (HIV-1 RNA <40 copies per mL) increased from 53% (144 of 272) at week 24 to 60% (163 of 272) at week 96.","[{'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Lataillade', 'Affiliation': 'ViiV Healthcare, Branford, CT, USA. Electronic address: max.x.lataillade@viivhealthcare.com.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Lalezari', 'Affiliation': 'Quest Clinical Research, San Francisco, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kozal', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases Section, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Pialoux', 'Affiliation': 'Department of Infectious and Tropical Diseases, Hôpital Tenon, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cahn', 'Affiliation': 'Fundación Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': 'AIDS Research Consortium of Atlanta, Atlanta, GA, USA.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Department of Infectious Diseases, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Moreno', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, Alcalá University, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': 'STD and AIDS Clinical Research Laboratory, Infectious Diseases, Instituto de Pesquisa Clínica Evandro Chagas FIOCRUZ, Rio De Janeiro, Brazil.'}, {'ForeName': 'Ricardo S', 'Initials': 'RS', 'LastName': 'Diaz', 'Affiliation': 'Infectious Diseases Division, Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Castagna', 'Affiliation': 'Clinic of Infectious Diseases, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Princy N', 'Initials': 'PN', 'LastName': 'Kumar', 'Affiliation': 'Department of Medicine and Microbiology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Gulam H', 'Initials': 'GH', 'LastName': 'Latiff', 'Affiliation': 'Maxwell Centre, Durban, South Africa.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'De Jesus', 'Affiliation': 'Orlando Immunology Center, Orlando, FL, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'GlaxoSmithKline, Upper Providence Township, PA, USA.'}, {'ForeName': 'Shiven', 'Initials': 'S', 'LastName': 'Chabria', 'Affiliation': 'ViiV Healthcare, Branford, CT, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Gartland', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Pierce', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ackerman', 'Affiliation': 'ViiV Healthcare, Branford, CT, USA.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Llamoso', 'Affiliation': 'ViiV Healthcare, Branford, CT, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30240-X']
1426,33128906,A Bayesian averted infection framework for PrEP trials with low numbers of HIV infections: application to the results of the DISCOVER trial.,"Trials of candidate agents for HIV pre-exposure prophylaxis (PrEP) might randomly assign participants to be given a new PrEP agent or oral coformulated tenofovir disoproxil fumarate plus emtricitabine. This design presents unique challenges in interpretation. First, with two active arms, HIV incidence might be low. Second, the effectiveness of tenofovir disoproxil fumarate plus emtricitabine varies across populations; thus, similar HIV incidence between groups could be consistent with a wide range of effectiveness for the new PrEP. We propose a two-part approach to trial results. First, we use Bayesian methods to incorporate assumptions about the background incidence of HIV in the trial in the absence of PrEP, possibly augmented by external data. On the basis of the estimated background incidence, we estimate and compare the number of averted (or prevented) HIV infections in each of the two trial groups, calculating the averted infections ratio. We apply these methods to a completed trial of tenofovir alafenamide plus emtricitabine for PrEP. Our framework shows that leveraging external information to estimate averted infections and the averted infections ratio enhances the efficiency and interpretation of active-controlled PrEP trials.",2020,Our framework shows that leveraging external information to estimate averted infections and the averted infections ratio enhances the efficiency and interpretation of active-controlled PrEP trials.,[],"['PrEP agent or oral coformulated tenofovir disoproxil fumarate plus emtricitabine', 'HIV pre-exposure prophylaxis (PrEP', 'tenofovir disoproxil fumarate plus emtricitabine', 'tenofovir alafenamide plus emtricitabine']",['number of averted (or prevented) HIV infections'],[],"[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}]",,0.217817,Our framework shows that leveraging external information to estimate averted infections and the averted infections ratio enhances the efficiency and interpretation of active-controlled PrEP trials.,"[{'ForeName': 'David V', 'Initials': 'DV', 'LastName': 'Glidden', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA. Electronic address: david.glidden@ucsf.edu.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Stirrup', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Dunn', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, UK.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30192-2']
1427,33129157,Long-term outcomes of Prompt Mental Health Care: A randomized controlled trial.,"Prompt Mental Health Care (PMHC, Norwegian adaptation of Improving Access to Psychological Therapies) is found successful in alleviating symptoms of anxiety and depression. Here, we investigate whether improvement is maintained over time. A randomized controlled trial was conducted in two PMHC sites from November 2015 to August 2017, randomly assigning 681 adults with anxiety and/or mild to moderate depression (70:30 ratio: PMHC n = 463, TAU n = 218). Main outcomes were recovery rates and changes in symptoms of depression and anxiety from baseline to 12 months. Secondary outcomes were functional status, health-related quality of life, mental wellbeing and work participation. At 12 months after baseline the reliable recovery rate was 59.4% in PMHC and 36.6% in TAU, giving a between-group effect size of 0.51 (95%CI: 0.26, 0.77, p < 0.001). Differences in symptom change gave between-group effect sizes of -0.67 (95%CI: -0.99, -0.36, p < 0.001) for depression and -0.58 (95%CI: -0.91, -0.26, p < 0.001) for anxiety. PMHC was also at 12 months found more effective in improving functional status, health-related quality of life and mental wellbeing, but not work participation. In sum, substantial treatment effects of PMHC remain at 12 months follow-up, although results should be interpreted with caution due to risk of attrition bias.",2020,"PMHC was also at 12 months found more effective in improving functional status, health-related quality of life and mental wellbeing, but not work participation.","['two PMHC sites from November 2015 to August 2017, randomly assigning 681 adults with anxiety and/or mild to moderate depression (70:30 ratio: PMHC n\xa0=\xa0463, TAU n\xa0=\xa0218']","['PMHC', '95%CI', 'Prompt Mental Health Care']","['functional status, health-related quality of life, mental wellbeing and work participation', 'functional status, health-related quality of life and mental wellbeing', 'reliable recovery rate', 'anxiety', 'recovery rates and changes in symptoms of depression and anxiety']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C4517647', 'cui_str': '218'}]","[{'cui': 'C0184643', 'cui_str': 'Mental health care'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",681.0,0.216902,"PMHC was also at 12 months found more effective in improving functional status, health-related quality of life and mental wellbeing, but not work participation.","[{'ForeName': 'Solbjørg Makalani', 'Initials': 'SM', 'LastName': 'Myrtveit Sæther', 'Affiliation': 'Department of Health Promotion, Norwegian Institute of Public Health, Zander Kaaes Gate 7, 5015, Bergen, Norway. Electronic address: makalani@myrtveit.com.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Knapstad', 'Affiliation': 'Department of Health Promotion, Norwegian Institute of Public Health, Zander Kaaes Gate 7, 5015, Bergen, Norway; Department of Clinical Psychology, University of Bergen, Bergen, Norway. Electronic address: marit.knapstad@fhi.no.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Grey', 'Affiliation': 'Sussex Partnership NHS Foundation Trust, United Kingdom; School of Psychology, University of Sussex, United Kingdom. Electronic address: n.Grey@sussex.ac.uk.'}, {'ForeName': 'Marit Aase', 'Initials': 'MA', 'LastName': 'Rognerud', 'Affiliation': 'Health Section, Oslo Municipality, Oslo, Norway. Electronic address: marogner@outlook.com.'}, {'ForeName': 'Otto R F', 'Initials': 'ORF', 'LastName': 'Smith', 'Affiliation': 'Department of Health Promotion, Norwegian Institute of Public Health, Zander Kaaes Gate 7, 5015, Bergen, Norway. Electronic address: robert.smith@fhi.no.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103758']
1428,33129298,Transdiagnostic treatment of emotional disorders for women with multiple sclerosis: a randomized controlled trial.,"BACKGROUND
Multiple sclerosis (MS) is a chronic, unpredictable, neurodegenerative disease, significantly associated with psychological, behavioral, cognitive, and emotional consequences. MS is more common in females than males and frequently affects women during their reproductive years. Despite the frequent mental disorders, comorbidities, and emotional problems in People with MS (PwMS), these conditions are too often underdiagnosed and undertreated.
OBJECTIVE
This study aimed to examine the efficacy of a group format of the Unified Protocol (UP) for the Transdiagnostic treatment of depression and anxiety disorders in females with MS.
METHODS
In the present study, Sixty-four adult females diagnosed with MS were randomized to either the UP (n = 32) or treatment-as-usual conditions. The assessment protocol included semi-structured clinical interviews and self-reports evaluating diagnostic criteria, depression, anxiety and worry symptoms, emotional regulation, and affectivity.
RESULTS
Repeated measure analysis of variance (ANOVA) revealed that the UP significantly improved depression scores [Cohen's d = - 2.11, 95% CI (- 2.72, - 1.50)], anxiety scores [Cohen's d = - 3.34, 95% CI (- 4.01, - 2.58)], positive and negative affect scale (PANAS)-positive affect scores [Cohen's d = 1.46, 95% CI (1.46, 2.01)], PANAS-negative affect scores [Coen's d = - 2.21, 95% CI (- 2.84, - 1.60)], difficulties emotion regulation scale scores [Cohen's d = 1.40, 95% CI (- 0.87, - 0.03)], and Worry scale scores [Cohen's d = - 0.45, 95% CI (- 0.95, - 0.04)] at the end of treatment relative to compared to the control condition. Also, treatment gains were maintained at the three-month follow-up (p < 0.001).
CONCLUSION
The findings provide the support that the UP could be an additional efficient psychological treatment for females with MS. ISRCTN Number: ISRCTN95459505.",2020,"Also, treatment gains were maintained at the three-month follow-up (p < 0.001).
","['depression and anxiety disorders in females with MS', 'Sixty-four adult females diagnosed with MS', 'women with multiple sclerosis', 'females with MS', 'ISRCTN Number']","['Transdiagnostic treatment', 'Unified Protocol (UP']","['anxiety scores', 'semi-structured clinical interviews and self-reports evaluating diagnostic criteria, depression, anxiety and worry symptoms, emotional regulation, and affectivity', 'depression scores', 'difficulties emotion regulation scale scores', 'Worry scale scores']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",64.0,0.127564,"Also, treatment gains were maintained at the three-month follow-up (p < 0.001).
","[{'ForeName': 'Nabi', 'Initials': 'N', 'LastName': 'Nazari', 'Affiliation': 'Department of Psychology, Faculty of Human Sciences, Lorestan University, Khorramabad, Iran. Nazariirani@gmail.com.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Aligholipour', 'Affiliation': 'Department of Psychology, Islamic Azad University, Hamadan Branch, Hamadan, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Psychology, Faculty of Human Sciences, Lorestan University, Khorramabad, Iran.'}]",BMC women's health,['10.1186/s12905-020-01109-z']
1429,33129304,"Health-related quality of life in patients with inoperable malignant bowel obstruction: secondary outcome from a double-blind, parallel, placebo-controlled randomised trial of octreotide.","BACKGROUND
This analysis aims to evaluate health-related quality of life (HrQoL) (primary outcome for this analysis), nausea and vomiting, and pain in patients with inoperable malignant bowel obstruction (IMBO) due to cancer or its treatments randomised to standardised therapies plus octreotide or placebo over a maximum of 72 h in a double-blind clinical trial.
METHODS
Adults with IMBO and vomiting recruited through 12 services spanning inpatient, consultative and community settings in Australia were randomised to subcutaneous octreotide infusion or saline. HrQoL was measured at baseline and treatment cessation (EORTC QLQ-C15-PAL). Mean within-group paired differences between baseline and post-treatment scores were analysed using Wilcoxon Signed Rank test and between group differences estimated using linear mixed models, adjusted for baseline score, sex, age, time, and study arm.
RESULTS
One hundred six of the 112 randomised participants were included in the analysis (n = 52 octreotide, n = 54 placebo); 6 participants were excluded due to major protocol violations. Mean baseline HrQoL scores were low (octreotide 22.1, 95% CI 14.3, 29.9; placebo 31.5, 95% CI 22.3, 40.7). There was no statistically significant within-group improvement in the mean HrQoL scores in the octreotide (p = 0.21) or placebo groups (p = 0.78), although both groups reported reductions in mean nausea and vomiting (octreotide p < 0.01; placebo p = 0.02) and pain scores (octreotide p < 0.01; placebo p = 0.03). Although no statistically significant difference in changes in HrQoL scores between octreotide and placebo were seen, an adequately powered study is required to fully assess any differences in HrQoL scores.
CONCLUSION
The HrQoL of patients with IMBO and vomiting is poor. Further research to formally evaluate the effects of standard therapies for IMBO is therefore warranted.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry ACTRN12608000211369 (date registered 18/04/2008).",2020,"There was no statistically significant within-group improvement in the mean HrQoL scores in the octreotide (p = 0.21) or placebo groups (p = 0.78), although both groups reported reductions in mean nausea and vomiting (octreotide p < 0.01; placebo p = 0.02) and pain scores (octreotide p < 0.01; placebo p = 0.03).","['One hundred six of the 112 randomised participants were included in the analysis (n\xa0=\u200952 octreotide, n\xa0', '6 participants were excluded due to major protocol violations', 'patients with inoperable malignant bowel obstruction', 'Adults with IMBO and vomiting recruited through 12 services spanning inpatient, consultative and community settings in Australia', 'patients with inoperable malignant bowel obstruction (IMBO']","['octreotide or placebo', '54 placebo', 'subcutaneous octreotide infusion or saline', 'placebo', 'octreotide']","['health-related quality of life (HrQoL', 'HrQoL', 'Health-related quality of life', 'HrQoL scores', 'Mean baseline HrQoL scores', 'nausea and vomiting, and pain', 'pain scores', 'mean nausea and vomiting', 'mean HrQoL scores']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0021843', 'cui_str': 'Intestinal obstruction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",6.0,0.818085,"There was no statistically significant within-group improvement in the mean HrQoL scores in the octreotide (p = 0.21) or placebo groups (p = 0.78), although both groups reported reductions in mean nausea and vomiting (octreotide p < 0.01; placebo p = 0.02) and pain scores (octreotide p < 0.01; placebo p = 0.03).","[{'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'McCaffrey', 'Affiliation': 'Deakin Health Economics, Centre for Population Health Research, School of Health and Social Development, Deakin University, Geelong, Victoria, Australia. nikki.mccaffrey@deakin.edu.au.'}, {'ForeName': 'Tegan', 'Initials': 'T', 'LastName': 'Asser', 'Affiliation': 'School of Medicine, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Fazekas', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Muircroft', 'Affiliation': 'Southern Adelaide Palliative Services, Southern Adelaide Local Health Network, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Agar', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': 'Cancer & Palliative Care Network, Northern Sydney Local Health District, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Eckermann', 'Affiliation': 'Centre for Health Service Development, Australian Health Services Research Institute, University of Wollongong, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Joshi', 'Affiliation': 'Medical Oncology, Lyell McEwin Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Allcroft', 'Affiliation': 'Southern Adelaide Palliative Services, Southern Adelaide Local Health Network, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Sheehan', 'Affiliation': 'Calvary Heath Care, Kogarah, New South Wales, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology, Ultimo, New South Wales, Australia.'}]",BMC cancer,['10.1186/s12885-020-07549-y']
1430,33129314,"Effectiveness of a psycho-educational intervention for expecting parents to prevent postpartum parenting stress, depression and anxiety: a randomized controlled trial.","BACKGROUND
The first months postpartum can be challenging for parents, leading to elevated symptoms of parenting stress, depression and anxiety. In turn, distressed parents are at higher risk for providing suboptimal quality of caregiving. As psychoeducational interventions can be effective in reducing psychological distress, the goal of this randomized controlled trial was to examine the effectiveness of low-intensity universal psychoeducational program to prevent postpartum parenting stress, and to enhance parental well-being and caregiving quality.
METHOD
Between 26 and 34 weeks of pregnancy, 138 pregnant women and 96 partners were randomized to the intervention or a waitlist control group. The intervention consisted of a booklet, a video, a home visit, and a telephone call. Information was provided on (1) sensitive responsiveness, adapting to the parental role, and attending to own needs; (2) crying patterns; (3) feeding (arrangements); and (4) sleeping (arrangements). The primary outcome was parenting stress postpartum. Secondary outcomes were additional measures of distress (depression and anxiety), parental well-being, and caregiving quality.
RESULTS
Both groups showed a rise in distress after birth. No between-group differences were observed on parenting stress, nor on the secondary outcomes. The intervention was rated as useful and of added value by the parents.
CONCLUSION
This study offered no evidence that our universal prevention program was effective in decreasing parental distress or in increasing caregiving quality. However, parents found aspects of the intervention useful. More research is needed, including a longer period of follow-up as well as observational measures of parents' responsiveness.
TRIAL REGISTRATION
This trial has been registered on 15 September 2016 in the Netherlands National Trial Register, ID: NTR6065, https://www.trialregister.nl/trial/5782 .",2020,"No between-group differences were observed on parenting stress, nor on the secondary outcomes.","['138 pregnant women and 96 partners', 'Between 26 and 34\u2009weeks of pregnancy', '15 September 2016 in the Netherlands National Trial Register, ID: NTR6065, https://www.trialregister.nl/trial/5782 ']","['low-intensity universal psychoeducational program', 'psycho-educational intervention', 'waitlist control group']","['psychological distress', 'parenting stress', 'parental distress', 'postpartum parenting stress, depression and anxiety', 'additional measures of distress (depression and anxiety), parental well-being, and caregiving quality', 'parenting stress postpartum']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",138.0,0.132204,"No between-group differences were observed on parenting stress, nor on the secondary outcomes.","[{'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Missler', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Section of Clinical Psychology & Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands. m.a.missler@vu.nl.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'van Straten', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Section of Clinical Psychology & Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Denissen', 'Affiliation': 'Department of Developmental Psychology, Utrecht University, Heidelberglaan 1, 3584 CS, Utrecht, The Netherlands.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Donker', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Section of Clinical Psychology & Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Roseriet', 'Initials': 'R', 'LastName': 'Beijers', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR, Nijmegen, The Netherlands.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03341-9']
1431,33129356,Transdiagnostic treatment of emotional disorders in people with multiple sclerosis: randomized controlled trial.,"BACKGROUND
Multiple sclerosis (MS) is a neurodegenerative disease of the central nervous system. MS is significantly associated with a high rate of psychological, behavioral, and emotional consequences. Despite the frequent mental disorders, high rate of psychological comorbidities, and emotional problems in people with MS (PwMS), these conditions are often underdiagnosed and undertreated. This study aimed to examine the efficacy of a group format of the unified protocol for the transdiagnostic treatment of emotional disorders in adult PwMS associated with an emotional disorder.
METHODS
Seventy adult PwMS were randomized using an internet-based computer system to either the unified protocol (n = 35) or treatment as usual condition. The assessment protocol included semi-structured clinical interviews and self-reports evaluating diagnostic criteria, depression, anxiety and worry symptoms, emotional dysregulation, and affectivity.
RESULTS
The parametric test of analysis of covariance, followed the intent to treat analyses, revealed the unified protocol significantly changed depression symptoms (Cohen's d = 1.9), anxiety symptoms (Cohen's d = 2.16), worry symptoms (Cohen's d = 1.27), emotion dysregulation (Cohen's d = 0.44), positive affect (Cohen's d = 1.51), and negative affect (Cohen's d = 1.89) compared with the control group. The unified protocol also significantly improved outcome scores at the end of treatment relative to baseline (p < .001).
CONCLUSION
The findings support that the unified protocol could be an additional efficient psychological treatment for PwMS. Trial registration IRCT, number: IRCT20190711044173N1. Registered 31october 2019, https://en.irct.ir/user/trial/40779/view .",2020,"The unified protocol also significantly improved outcome scores at the end of treatment relative to baseline (p < .001).
","['people with multiple sclerosis', 'Seventy adult PwMS', 'emotional disorders in adult PwMS associated with an emotional disorder']","['internet-based computer system to either the unified protocol (n\u2009=\u200935) or treatment as usual condition', 'Transdiagnostic treatment']","['emotion dysregulation', 'semi-structured clinical interviews and self-reports evaluating diagnostic criteria, depression, anxiety and worry symptoms, emotional dysregulation, and affectivity', 'depression symptoms', 'anxiety symptoms', 'outcome scores', 'worry symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009612', 'cui_str': 'Computer Systems'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",70.0,0.119779,"The unified protocol also significantly improved outcome scores at the end of treatment relative to baseline (p < .001).
","[{'ForeName': 'Nabi', 'Initials': 'N', 'LastName': 'Nazari', 'Affiliation': 'Department of Psychology, Faculty of Human Sciences, Lorestan University, Khorramabad, Iran. Nazariirani@gmail.com.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Psychology, Faculty of Human Sciences, Lorestan University, Khorramabad, Iran.'}, {'ForeName': 'Ezatolah', 'Initials': 'E', 'LastName': 'Ghadampour', 'Affiliation': 'Department of Psychology, Faculty of Human Sciences, Lorestan University, Khorramabad, Iran.'}, {'ForeName': 'Davod', 'Initials': 'D', 'LastName': 'Mirzaeefar', 'Affiliation': 'Department of Psychology, Faculty of Human Sciences, Lorestan University, Khorramabad, Iran.'}]",BMC psychology,['10.1186/s40359-020-00480-8']
1432,33129455,The effects of prolonged exposure to hypoxia and Florida red tide (Karenia brevis) on the survival and activity of stone crabs.,"Florida red tides are harmful algae blooms caused by the dinoflagellate Karenia brevis, which occur along Florida's gulf coast almost annually. In recent years Florida red tide blooms have become more common, frequent, and intense. Florida's southwest coast, from Manatee to Collier County, has experienced repeated and prolonged K. brevis blooms since 2011 with the most recent bloom in 2017 lasting 17 months and resulting in both hypoxic and anoxic events. We therefore determined the survival and level of lethargy (e.g., lack of responsiveness or reduction in behavioral reactions) of sublegal stone crabs to K. brevis and hypoxia as both singular and simultaneous stressors. Crabs were randomly assigned to one of six treatments that included: 1) high concentration of toxic K. brevis (> 1 million cells L -1 ) maintained at normoxic levels (7.2 mg L -1 ± S.D. 0.47 dissolved oxygen), 2) moderate hypoxia (1.6 mg L -1 ± S.D. 0.42 dissolved oxygen) with no K. brevis, 3) moderate hypoxia (1.5 mg L -1 ± S.D. 0.43 dissolved oxygen) with a high concentration of K. brevis, 4) severe hypoxia with no K. brevis (0.69 mg L -1 ± S.D. 0.36 dissolved oxygen), 5) severe hypoxia (0.63 mg L -1 ± S.D. 0.40 dissolved oxygen) with a high concentration of K. brevis, and 6) a normoxic control (7.3 mg L -1 ± S.D. 0.61 dissolved oxygen) with no K. brevis. Survival and stone crab lethargy or responsiveness was monitored every 10-12 h for six days. Crabs simultaneously exposed to K. brevis and severe hypoxia exhibited a 43% decrease in survival and experienced increased lethargy within 24 h relative to the control (7% decrease in survival, no increase in lethargy). The increase in stress level and sluggish behavior during exposure to hypoxia was evident by a general lack of responsiveness or movement which indicates that nearshore populations of stone crabs are unlikely to emigrate away from such conditions suggesting that future harvests may be reduced following prolonged K. brevis blooms and hypoxic events.",2020,"Crabs simultaneously exposed to K. brevis and severe hypoxia exhibited a 43% decrease in survival and experienced increased lethargy within 24 h relative to the control (7% decrease in survival, no increase in lethargy).",[],"['prolonged exposure to hypoxia and Florida red tide (Karenia brevis', 'toxic K. brevis (> 1 million cells L -1 ) maintained at normoxic levels ']","['lethargy', 'stress level and sluggish behavior', 'survival', 'survival and level of lethargy', 'survival and activity of stone crabs', 'severe hypoxia', 'moderate hypoxia', 'Survival and stone crab lethargy or responsiveness']",[],"[{'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0599962', 'cui_str': 'Red Tide'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0022827', 'cui_str': 'L-Cells'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0998252', 'cui_str': 'Family Lithodidae'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.0519635,"Crabs simultaneously exposed to K. brevis and severe hypoxia exhibited a 43% decrease in survival and experienced increased lethargy within 24 h relative to the control (7% decrease in survival, no increase in lethargy).","[{'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Gravinese', 'Affiliation': 'Mote Marine Laboratory, Fisheries Ecology and Enhancement Program, 1600 Ken Thompson Parkway, Sarasota, FL 34236, United States; Florida Southern College, Department of Biological Sciences, 111 Lake Hollingsworth Drive, Lakeland, FL 33801, United States. Electronic address: pgravinese@mote.org.'}, {'ForeName': 'Mary Kate', 'Initials': 'MK', 'LastName': 'Munley', 'Affiliation': 'Department of Biological Sciences, University of New Hampshire, 38 Academic Way Durham, NH 03824, United States.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kahmann', 'Affiliation': 'Department of Biology, Thomas More University, 333 Thomas More Parkway Crestview Hills, KY 41017, United States.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Cole', 'Affiliation': 'Phytoplankton Ecology Program, Mote Marine Laboratory, 1600 Ken Thompson Parkway, Sarasota, FL 34236, United States.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Lovko', 'Affiliation': 'Phytoplankton Ecology Program, Mote Marine Laboratory, 1600 Ken Thompson Parkway, Sarasota, FL 34236, United States.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Blum', 'Affiliation': 'Ecotoxicology Program, Mote Marine Laboratory, 1600 Ken Thompson Parkway, Sarasota, FL 34236, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pierce', 'Affiliation': 'Ecotoxicology Program, Mote Marine Laboratory, 1600 Ken Thompson Parkway, Sarasota, FL 34236, United States.'}]",Harmful algae,['10.1016/j.hal.2020.101897']
1433,33129501,Three-year outcomes of the postapproval study of the AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation Trial.,"OBJECTIVES
The Cox Maze IV operation is commonly performed concomitant with other cardiac operations and effectively reduces the burden of atrial fibrillation. Prospective randomized trials have reported outcomes early and at 12 months, but only single-center late durability results are available. As part of the postapproval process for a bipolar radiofrequency ablation system, we sought to determine early and midterm outcomes of patients undergoing the Cox Maze IV operation.
METHODS
A prospective, multicenter, single-arm study of 363 patients (mean age, 70 years, 82% valve surgery) with nonparoxysmal atrial fibrillation (mean duration, 60 months, 94% Congestive heart failure, Hypertension, Age ≥ 75, Diabetes, Stroke, VAScular disease, Age 65-74, Sex category ≥2) undergoing concomitant Maze IV atrial fibrillation ablation at 40 sites with 70 surgeons was performed between June 2010 and October 2014. Compliance with the study lesion set was 94.5%, and 99% had left atrial appendage closure. Freedom from atrial fibrillation was determined by extended monitoring, with a 48-hour Holter monitor minimum.
RESULTS
There were no device-related complications. Freedom from atrial fibrillation off antiarrhythmic medications at 1, 2, and 3 years was 66%, 65%, and 64%, respectively, and including those using antiarrhythmics was 80%, 78%, and 76%, respectively. Warfarin was used in 49%, 44%, and 40%, respectively.
CONCLUSIONS
In patients with nonparoxysmal atrial fibrillation, compliance with the protocol was high, and freedom from atrial fibrillation off antiarrhythmics was high and sustained to 3 years. The safety and effectiveness of the system and Cox Maze IV procedure support the Class I guideline recommendation for concomitant atrial fibrillation ablation in patients undergoing cardiac surgery.",2020,There were no device-related complications.,"['patients undergoing cardiac surgery', '363 patients (mean age, 70\xa0years, 82% valve surgery) with nonparoxysmal atrial fibrillation (mean duration, 60\xa0months, 94% Congestive heart failure, Hypertension, Age', '≥\xa075, Diabetes, Stroke, VAScular disease, Age 65-74, Sex category ≥2) undergoing concomitant Maze IV atrial fibrillation ablation at 40 sites with 70 surgeons was performed between June 2010 and October 2014', 'patients with nonparoxysmal atrial fibrillation, compliance with the protocol was high, and freedom from atrial fibrillation off antiarrhythmics was high and sustained to 3\xa0years', 'patients undergoing the Cox Maze IV operation']","['AtriCure Bipolar Radiofrequency Ablation', 'Warfarin']","['left atrial appendage closure', 'burden of atrial fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0083355', 'cui_str': 'MAZE protocol'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C4759306', 'cui_str': 'Left atrial appendage closure'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",363.0,0.0391548,There were no device-related complications.,"[{'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'McCarthy', 'Affiliation': 'Division of Cardiac Surgery, Northwestern University Feinberg School of Medicine, Bluhm Cardiovascular Institute, Chicago, Ill. Electronic address: pmccart@nm.org.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Gerdisch', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Franciscan St Francis Heart Center, Indianapolis, Ind.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Philpott', 'Affiliation': 'Sentara Heart Hospital, Norfolk, Va.'}, {'ForeName': 'Glenn R', 'Initials': 'GR', 'LastName': 'Barnhart', 'Affiliation': 'Swedish Heart and Vascular Institute, Swedish Medical Center, Seattle, Wash.'}, {'ForeName': 'Albert L', 'Initials': 'AL', 'LastName': 'Waldo', 'Affiliation': 'Division of Cardiovascular Medicine, Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Shemin', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, School of Medicine at UCLA, Los Angeles, Calif.'}, {'ForeName': 'Adin-Cristian', 'Initials': 'AC', 'LastName': 'Andrei', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, Ill.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Gaynor', 'Affiliation': 'AtriCure, Inc, Mason, Ohio.'}, {'ForeName': 'Nfii', 'Initials': 'N', 'LastName': 'Ndikintum', 'Affiliation': 'AtriCure, Inc, Mason, Ohio.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Calkins', 'Affiliation': 'Division of Cardiology, Johns Hopkins Hospital, Baltimore, Md.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.09.099']
1434,33129628,Efficacy of a dyadic intervention to improve communication between patients with cancer and their caregivers: A randomized pilot trial.,"OBJECTIVE
Cancer-related communication is critical for patients' and caregivers' adaptation to illness. This randomized pilot study was conducted to test the feasibility, acceptability, and efficacy of a specific dyadic intervention to improve communication.
METHODS
A four weekly-session intervention was developed to reinforce cancer-related patient-caregiver communication. Patients receiving treatment for any diagnosed cancer, and their caregivers, were recruited from two oncology clinics in Belgium. Sixty-four patient-caregiver dyads were assigned randomly to intervention and waitlist groups. Cancer-related dyadic communication, dyadic coping and emotional distress were assessed at baseline and post-intervention.
RESULTS
The intervention attrition rate was 6 %. Linear mixed models were performed on 60 dyads. Significant two-way group × time interaction indicated improvement in participants' cancer-related dyadic communication frequency (β = -1.30; SE = .31; p = .004), self-efficacy (β = -10.03; SE = 3.90; p = .011) and dyadic coping (β = -5.93; SE = 2.73; p = .046) after the intervention.
CONCLUSION
These results indicate that the brief dyadic communication intervention is feasible and acceptable, and show preliminary evidence of efficacy.
PRACTICE IMPLICATIONS
Encouraging patients and caregivers to discuss personal cancer-related concerns may improve their ability to cope with the illness together.",2020,"This randomized pilot study was conducted to test the feasibility, acceptability, and efficacy of a specific dyadic intervention to improve communication.
","['Patients receiving treatment for any diagnosed cancer, and their caregivers, were recruited from two oncology clinics in Belgium', 'Sixty-four patient-caregiver dyads', 'patients with cancer and their caregivers']","['specific dyadic intervention', 'dyadic intervention', 'dyadic communication intervention']","[""participants' cancer-related dyadic communication frequency"", 'intervention attrition rate', 'Cancer-related dyadic communication, dyadic coping and emotional distress', 'dyadic coping', 'feasibility, acceptability, and efficacy', 'self-efficacy', 'reinforce cancer-related patient-caregiver communication']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",60.0,0.0387665,"This randomized pilot study was conducted to test the feasibility, acceptability, and efficacy of a specific dyadic intervention to improve communication.
","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Tiete', 'Affiliation': ""Université Libre de Bruxelles, Faculté des Sciences Psychologiques et de l'Education, 50 Avenue Franklin Roosevelt, Brussels, Belgium; Hôpital Erasme, Service de Psychologie, 808 Route de Lennik, Brussels, Belgium. Electronic address: julien.tiete@erasme.ulb.ac.be.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Delvaux', 'Affiliation': ""Université Libre de Bruxelles, Faculté des Sciences Psychologiques et de l'Education, 50 Avenue Franklin Roosevelt, Brussels, Belgium; Hôpital Erasme, Service de Psychologie, 808 Route de Lennik, Brussels, Belgium.""}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Liénard', 'Affiliation': 'Institut Jules Bordet, Clinique de Psycho-oncologie, 121 Boulevard de Waterloo, Brussels, Belgium.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Razavi', 'Affiliation': ""Université Libre de Bruxelles, Faculté des Sciences Psychologiques et de l'Education, 50 Avenue Franklin Roosevelt, Brussels, Belgium; Institut Jules Bordet, Clinique de Psycho-oncologie, 121 Boulevard de Waterloo, Brussels, Belgium.""}]",Patient education and counseling,['10.1016/j.pec.2020.08.024']
1435,33129630,Effect of nurse-led program on the exercise behavior of coronary artery patients: Pender's Health Promotion Model.,"OBJECTIVE
To determine the effect of nurse-led program based on Pender's Health Promotion Model on the exercise behaviors of coronary artery patients.
METHODS
The two-arm parallel, single-blind, randomized controlled trial was conducted with a total of 62 patients, intervention (n = 32) and control group (n = 30). Intervention group received a nurse-led program based on Pender's Health Promotion Model and routine follow-ups of control group continued. The health perception, perceived exercise self efficacy, perceived exercise benefits/barriers, exercise-related effect, exercise frequency and time were assessed at baseline, 4th, 8th and 12th weeks. The data were evaluated by frequency, percentage, median, mean and standard deviation, chi-square, Friedman and Mann Whitney U tests.
RESULTS
Health perception (62.6 ± 9.5; median:67.0; p < 0.001), perceived exercise benefit (105.8 ± 7.4; median:107.0; p < 0.001), perceived exercise self efficacy (71.2 ± 5.4; median: 71.5; p < 0.05), exercise-related effect (31.6 ± 6.0; median:34.0; p < 0.05), exercise frequency (4.8 ± 2.2; median:6.0 days/week; p < 0.05) and time (105.9 ± 53.6; median:130.0 min/week; p < 0.05) were higher and perceived barriers (43.1 ± 3.9; median: 42.0; p < 0.001) were lower in the intervention group at 12th week.
CONCLUSIONS
The nurse-led program has been shown to increase the exercise behavior in the intervention group.
PRACTICE IMPLICATIONS
Since it enables patients to gain and maintain exercise, it is highlighted the model to be integrated into clinical practice.",2020,"RESULTS
Health perception (62.6 ± 9.5; median:67.0; p < 0.001), perceived exercise benefit (105.8 ± 7.4; median:107.0; p < 0.001), perceived exercise self efficacy (71.2 ± 5.4; median: 71.5; p < 0.05), exercise-related effect (31.6 ± 6.0; median:34.0; p < 0.05), exercise frequency (4.8 ± 2.2; median:6.0 days/week; p < 0.05) and time (105.9 ± 53.6; median:130.0 min/week; p < 0.05) were higher and perceived barriers (43.1 ± 3.9; median: 42.0; p < 0.001) were lower in the intervention group at 12th week.
","['62 patients, intervention (n = 32) and control group (n = 30', 'coronary artery patients']","['nurse-led program', ""nurse-led program based on Pender's Health Promotion Model"", ""nurse-led program based on Pender's Health Promotion Model and routine follow-ups of control group continued""]","['health perception, perceived exercise self efficacy, perceived exercise benefits/barriers, exercise-related effect, exercise frequency and time', 'exercise behavior', 'exercise frequency', 'perceived exercise benefit', 'perceived exercise self efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0556455', 'cui_str': 'Frequency of exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",62.0,0.0357089,"RESULTS
Health perception (62.6 ± 9.5; median:67.0; p < 0.001), perceived exercise benefit (105.8 ± 7.4; median:107.0; p < 0.001), perceived exercise self efficacy (71.2 ± 5.4; median: 71.5; p < 0.05), exercise-related effect (31.6 ± 6.0; median:34.0; p < 0.05), exercise frequency (4.8 ± 2.2; median:6.0 days/week; p < 0.05) and time (105.9 ± 53.6; median:130.0 min/week; p < 0.05) were higher and perceived barriers (43.1 ± 3.9; median: 42.0; p < 0.001) were lower in the intervention group at 12th week.
","[{'ForeName': 'Tuğba', 'Initials': 'T', 'LastName': 'Karataş', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Nursing, 06490, Ankara, Turkey. Electronic address: tkarats@hotmail.com.'}, {'ForeName': 'Ülkü', 'Initials': 'Ü', 'LastName': 'Polat', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Nursing, 06490, Ankara, Turkey. Electronic address: ulku_gorgulu@yahoo.com.'}]",Patient education and counseling,['10.1016/j.pec.2020.10.003']
1436,33129656,"A prospective, up-down sequential allocation study investigating the effectiveness of vital capacity breaths using high-flow nasal oxygenation versus a tight-fitting face mask to pre-oxygenate term pregnant women.","BACKGROUND
The role of high flow nasal oxygenation (HFNO) for pre-oxygenation before obstetric general anaesthesia remains unclear. This study aimed to determine the number of vital capacity breaths using HFNO required to pre-oxygenate 90% of parturients to an end-tidal oxygen concentration fraction (F ET O 2 ) of ≥0.90 (termed EN90).
METHODS
Using up-down, sequential allocation trial design, volunteer term parturients undergoing caesarean delivery were investigated with HFNO with their mouths closed, followed by mouths open, and if F ET O 2 ≥0.90 was not achieved after a maximum of 20 vital capacity breaths, pre-oxygenation was attempted with a face mask. The primary outcome was the number of vital capacity breaths required using HFNO (mouth open and closed) to achieve EN90. Secondary outcomes included assessment of EN90 using mouth open versus mouth closed and face mask pre-oxygenation, maternal satisfaction and evaluation of fetal cardiotocography.
RESULTS
Twenty women at term were recruited. Successful pre-oxygenation occurred in 4 (20%), 3 (15%) and 14 (70%) women with HFNO mouth closed, HFNO mouth open, and via face mask respectively. At up to 20 vital capacity breaths, face mask pre-oxygenation was more successful at achieving EN90 compared with both HFNO with a closed (P=0.006) or open (P=0.001) mouth. Closed mouth HFNO did not outperform open-mouth pre-oxygenation.
CONCLUSION
Face mask pre-oxygenation is more effective at achieving EN90 compared to HFNO within a clinically acceptable number of vital capacity breaths. Further studies are needed to determine the role of HFNO in optimising the time before desaturation and for apnoeic oxygenation in term parturients.",2020,"Closed mouth HFNO did not outperform open-mouth pre-oxygenation.
CONCLUSION
Face mask pre-oxygenation is more effective at achieving EN90 compared to HFNO within a clinically acceptable number of vital capacity breaths.","['Twenty women at term were recruited', 'term pregnant women', 'volunteer term parturients undergoing caesarean delivery']","['high flow nasal oxygenation (HFNO', 'vital capacity breaths using high-flow nasal oxygenation versus a tight-fitting face mask to pre-oxygenate']","['assessment of EN90 using mouth open versus mouth closed and face mask pre-oxygenation, maternal satisfaction and evaluation of fetal cardiotocography', 'Successful pre-oxygenation', 'number of vital capacity breaths required using HFNO (mouth open and closed) to achieve EN90']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0007208', 'cui_str': 'CTG, Antepartum'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]",,0.0773586,"Closed mouth HFNO did not outperform open-mouth pre-oxygenation.
CONCLUSION
Face mask pre-oxygenation is more effective at achieving EN90 compared to HFNO within a clinically acceptable number of vital capacity breaths.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Al-Sulttan', 'Affiliation': 'Department of Anaesthesia, University College London NHS Trust, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bampoe', 'Affiliation': 'Department of Anaesthesia, University College London NHS Trust, London, UK; University College London, UK. Electronic address: S.bampoe@ucl.ac.uk.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Howle', 'Affiliation': 'Department of Anaesthesia, University College London NHS Trust, London, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Setty', 'Affiliation': 'Anaesthesia, Queens Medical Centre, Nottingham, UK; Anaesthesia & Intensive Care Medicine, University of Manchester Hospitals NHS Foundation Trust, Wythenshawe Hospital, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Columb', 'Affiliation': 'Department of Anaesthesia, University College London Hospitals NHS Trust, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'University College London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fernando', 'Affiliation': ""The Women's Wellness and Research Centre, Hamad Medical Corporation, Doha, Qatar.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Husain', 'Affiliation': 'Anaesthesia, Ashford & St Peters NHS Foundation Trust, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sultan', 'Affiliation': 'Stanford University School of Medicine, CA, USA.'}]",International journal of obstetric anesthesia,['10.1016/j.ijoa.2020.08.004']
1437,33129680,Compression Stocking With 100% Donning and Doffing Success: An Open Label Randomised Controlled Trial.,"OBJECTIVE
The aim of this study was to test whether an investigational two layer stocking exerting 27-29 mmHg pressure at the medial supramalleolar level, but without compression in the foot and heel, is easier to put on and take off than a standard stocking of the same compression class (23-32 mmHg), and also to assess the prevention of diurnal oedema with both types of stocking.
METHODS
This was an open label randomised controlled trial, which included 47 patients. All participants were at least 65 years of age and suffered from chronic venous disease class C3 - C6 in one leg. The primary end point was donning success; secondary endpoints were doffing success, prevention of diurnal oedema over one day, and the comfort of wearing the stocking. Patients were randomly allocated to one of two groups. Both types of compression stocking were compared in each group for ease of donning and doffing in the manner of a crossover study. Subsequently, patients wore the stocking type assigned to their group for a whole day to evaluate comfort and the effect on diurnal leg volume.
RESULTS
All participants were able to don the investigational stocking unaided, compared with 75% for the standard stocking (p < .001). Unaided removal success was 100% with the investigational stocking vs. 66% for the standard stocking (p < .001). There was no significant difference in leg volume reduction between the study groups after a day of wear. The investigational stocking was also rated as being more comfortable than the standard stocking (p < .001).
CONCLUSION
The investigational stocking, which has no compression in the foot or heel area, is significantly easier to don and doff, with no inferiority in oedema prevention, compared with a standard stocking of the same compression class.",2020,"The investigational stocking was also rated as being more comfortable than the standard stocking (p < .001).
","['47 patients', 'All participants were at least 65 years of age and suffered from chronic venous disease class C3 - C6 in one leg']",['Compression Stocking'],"['diurnal leg volume', 'Unaided removal success', 'leg volume reduction', 'success, prevention of diurnal oedema over one day, and the comfort of wearing the stocking']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235522', 'cui_str': 'Disorder of vein'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0038348', 'cui_str': 'Compression stocking'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439846', 'cui_str': 'Unaided'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0445269', 'cui_str': 'Socks'}]",,0.0746537,"The investigational stocking was also rated as being more comfortable than the standard stocking (p < .001).
","[{'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Buset', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fleischer', 'Affiliation': 'SIGVARIS AG, St. Gallen, Switzerland.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Kluge', 'Affiliation': 'SIGVARIS AG, St. Gallen, Switzerland.'}, {'ForeName': 'Nicole T', 'Initials': 'NT', 'LastName': 'Graf', 'Affiliation': 'Graf Biostatistics, Winterthur, Switzerland.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Mosti', 'Affiliation': 'Clinica MD Barbantini, Lucca, Italy.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Partsch', 'Affiliation': 'Professor Emeritus of Dermatology, Medical Faculty of the University of Vienna, Vienna, Austria.'}, {'ForeName': 'Corsin', 'Initials': 'C', 'LastName': 'Seeli', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Anzengruber', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Kockaert', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Hübner', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Hafner', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland. Electronic address: juerg.hafner@usz.ch.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.09.027']
1438,33129688,Anatomical characteristics associated with hypoattenuated leaflet thickening in low-risk patients undergoing transcatheter aortic valve replacement.,"BACKGROUND/PURPOSE
This sub-analysis of the prospective Low Risk TAVR (LRT) trial determined anatomical characteristics associated with hypoattenuated leaflet thickening (HALT), which may contribute to early transcatheter heart valve (THV) degeneration.
METHODS/MATERIALS
The LRT trial enrolled 200 low-risk patients between February 2016 and February 2018. All subjects underwent baseline and 30-day CT studies, analyzed by an independent core laboratory. Additional measurements, namely THV expansion, eccentricity, depth, and commissural alignment, were made by consensus of three independent readers. HALT was observed only in the Sapien 3 THV, so Evolut valves were excluded from this analysis.
RESULTS
In the LRT trial, 177 subjects received Sapien 3 THVs, of whom 167 (94.3%) had interpretable 30-day CTs and were eligible for this analysis. Twenty-six subjects had HALT (15.6%). Baseline characteristics were similar between groups. There was no difference in THV size implanted and baseline aortic-root geometry between groups. In patients who developed HALT, THV implantation depth was shallower than in patients who did not develop HALT (2.6 ± 1.1 mm HALT versus 3.3 ± 1.8 mm no-HALT, p = 0.03). There were more patients in the HALT group with commissural malalignment (40% vs. 28%; p = 0.25), but this did not reach statistical significance. In a univariable regression model, no predetermined variables were shown to independently predict the development of HALT.
CONCLUSIONS
This study did not find anatomical or THV implantation characteristics that predicted the development of HALT at 30 days. This study cannot exclude subtle effects or interaction between factors because of the small number of events.
SUMMARY
This sub-analysis of the prospective Low Risk TAVR trial found that hypoattenuated leaflet thickening (HALT) was associated with shallower transcatheter heart valve implantation. No predictors of HALT were found in a univariable regression analysis.",2020,"In patients who developed HALT, THV implantation depth was shallower than in patients who did not develop HALT (2.6 ± 1.1 mm HALT versus 3.3 ± 1.8 mm no-HALT, p = 0.03).","['177 subjects received Sapien 3 THVs, of whom 167 (94.3%) had interpretable 30-day CTs and were eligible for this analysis', 'low-risk patients undergoing transcatheter aortic valve replacement', '200 low-risk patients between February 2016 and February 2018']",['hypoattenuated leaflet thickening (HALT'],"['Additional measurements, namely THV expansion, eccentricity, depth, and commissural alignment', 'commissural malalignment', 'THV size implanted and baseline aortic-root geometry', 'HALT, THV implantation depth']","[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0205400', 'cui_str': 'Thickened'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C0449829', 'cui_str': 'Geometry'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",200.0,0.259272,"In patients who developed HALT, THV implantation depth was shallower than in patients who did not develop HALT (2.6 ± 1.1 mm HALT versus 3.3 ± 1.8 mm no-HALT, p = 0.03).","[{'ForeName': 'Jaffar M', 'Initials': 'JM', 'LastName': 'Khan', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America; Cardiovascular Branch, Division of Intramural Research, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD, United States of America.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Rogers', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America; Cardiovascular Branch, Division of Intramural Research, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD, United States of America.'}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Weissman', 'Affiliation': 'Department of Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Torguson', 'Affiliation': 'Department of Cardiovascular Research and Clinical Trials, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Rodriguez-Weisson', 'Affiliation': 'MedStar Health Research Institute, MedStar Washington Hospital Center, Washington, DC, United States of America.'}, {'ForeName': 'Chava', 'Initials': 'C', 'LastName': 'Chezar-Azerrad', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Greenspun', 'Affiliation': 'Georgetown University, Washington, DC, United States of America.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Department of Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Medvedofsky', 'Affiliation': 'MedStar Health Research Institute, MedStar Washington Hospital Center, Washington, DC, United States of America.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gordon', 'Affiliation': 'Division of Cardiology, The Miriam Hospital, Providence, RI, United States of America.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Ehsan', 'Affiliation': 'Division of Cardiothoracic Surgery, Lifespan Cardiovascular Institute, Providence, RI, United States of America.'}, {'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, The Valley Hospital, Ridgewood, NJ, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Goncalves', 'Affiliation': 'Cardiac Surgery Program, The Valley Hospital, Ridgewood, NJ, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Levitt', 'Affiliation': ""Department of Cardiology, Henrico Doctors' Hospital, Richmond, VA, United States of America.""}, {'ForeName': 'Chiwon', 'Initials': 'C', 'LastName': 'Hahn', 'Affiliation': ""Department of Cardiothoracic Surgery, Henrico Doctors' Hospital, Richmond, VA, United States of America.""}, {'ForeName': 'Puja', 'Initials': 'P', 'LastName': 'Parikh', 'Affiliation': 'Department of Medicine, Stony Brook Hospital, Stony Brook, NY, United States of America.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bilfinger', 'Affiliation': 'Department of Surgery, Stony Brook Hospital, Stony Brook, NY, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Butzel', 'Affiliation': 'Cardiovascular Service Line, Maine Medical Center, Portland, ME, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Buchanan', 'Affiliation': 'Cardiovascular Service Line, Maine Medical Center, Portland, ME, United States of America.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hanna', 'Affiliation': 'St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, OK, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garrett', 'Affiliation': 'St. John Clinic Cardiovascular Surgery, St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, OK, United States of America.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Shults', 'Affiliation': 'Department of Cardiac Surgery, MedStar Washington Hospital Center, Washington, DC, United States of America.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Buchbinder', 'Affiliation': 'Foundation for Cardiovascular Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Hector M', 'Initials': 'HM', 'LastName': 'Garcia-Garcia', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kolm', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.'}, {'ForeName': 'Lowell F', 'Initials': 'LF', 'LastName': 'Satler', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.'}, {'ForeName': 'Hayder', 'Initials': 'H', 'LastName': 'Hashim', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.'}, {'ForeName': 'Itsik', 'Initials': 'I', 'LastName': 'Ben-Dor', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.'}, {'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Asch', 'Affiliation': 'MedStar Health Research Institute, MedStar Washington Hospital Center, Washington, DC, United States of America.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America. Electronic address: ron.waksman@medstar.net.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2020.09.034']
1439,33129705,A Randomized Controlled Trial of Music for Pain Relief after Arthroplasty Surgery.,"PURPOSE
Effective pain management for patients undergoing orthopedic surgery, using pharmacological and nonpharmacological strategies, is essential. This pilot study evaluated music as an adjuvant therapy with prescribed analgesics to reduce acute pain and analgesic use among patients undergoing arthroplasty surgery.
DESIGN
Prospective randomized controlled trial of 50 participants scheduled for arthroplasty surgery at a large university-affiliated hospital.
METHODS
Participants were randomly assigned to treatment (music and analgesic medication; n = 25) or control (analgesic medication only; n = 25) groups. The intervention consisted of listening to self-selected music for 30 minutes, three times per day postoperatively in hospital and for 2 days postdischarge at home. Participants rated pain intensity and distress before and after music listening (treatment group) or meals (control group). Analgesic medication use was assessed via medical records in hospital and self-report logs postdischarge.
RESULTS
Forty-seven participants completed the study. Participants who listened to music after surgery reported significantly lower pain intensity and distress in hospital and postdischarge at home. There were no statistically significant differences in analgesic medication use after surgery between groups.
CONCLUSIONS
Study findings provide further evidence for the effectiveness of music listening, combined with analgesics, for reducing postsurgical pain, and extend the literature by examining music listening postdischarge. Music listening is an effective adjuvant pain management strategy. It is easy to administer, accessible, and affordable. Patient education is needed to encourage patients to continue to use music to reduce pain at home during the postoperative recovery period.",2020,Participants who listened to music after surgery reported significantly lower pain intensity and distress in hospital and postdischarge at home.,"['50 participants scheduled for arthroplasty surgery at a large university-affiliated hospital', 'patients undergoing orthopedic surgery', 'patients undergoing arthroplasty surgery', 'Participants', 'after Arthroplasty Surgery', 'Forty-seven participants completed the study']","['Music', 'Music listening', 'treatment (music and analgesic medication; n\xa0=\xa025) or control (analgesic medication only; n\xa0=\xa025) groups', 'music listening (treatment group) or meals (control group']","['pain intensity and distress', 'analgesic medication', 'Pain Relief', 'pain intensity and distress in hospital and postdischarge at home']","[{'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",50.0,0.294345,Participants who listened to music after surgery reported significantly lower pain intensity and distress in hospital and postdischarge at home.,"[{'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Laframboise-Otto', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, Florida. Electronic address: lafrajm@ufl.edu.'}, {'ForeName': 'MaryBeth', 'Initials': 'M', 'LastName': 'Horodyski', 'Affiliation': 'Department of Orthopedics & Rehabilitation, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Hari K', 'Initials': 'HK', 'LastName': 'Parvataneni', 'Affiliation': 'Department of Orthopedics & Rehabilitation, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Horgas', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, Florida.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2020.09.003']
1440,33129963,"Fosfomycin-trometamol (FT) or fluoroquinolone (FQ), as single-dose prophylaxis for transrectal ultrasound-guided prostate biopsy (TRUS-PB): a prospective cohort study.","OBJECTIVES
The increasing incidence of fluoroquinolones (FQ) resistance may lower its efficacy in preventing UTI following transrectal ultrasound-guided prostate biopsy (TRUS-PB). We assessed the efficacy and safety of FQ and fosfomycin-trometamol (FT) in patients undergoing TRUS-PB.
METHODS
Prospective observational study between April-2017 and June-2019, enrolling adults men undergoing TRUS-PB and receiving a single-dose of FQ (FQ-arm) or FT (FT-arm) for UTI prophylaxis as-per physician choice. The primary efficacy endpoint was self-reported TRUS-PB UTI. We assessed baseline factors associated with UTI with logistic regression.
RESULTS
222 men were enrolled, 141/222 (64%) received FQ and 81/222 (36%) FT. Median age was 67.6 years [IQR, 61.4-72.1] and Charlson score 3 [IQR, 3-5]. The overall incidence of self-reported TRUS-PB UTI was 12% (24/197, (95%CI, 8-17%)): 15% (17/116, (95%CI, 10-17%)) in FQ-arm, versus 9% (7/81, 95%CI (5-13%)) in FT-arm (RR = 0.55 (95%CI, 0.22-1.40), p-value = 0.209). No baseline characteristic was significantly associated with TRUS-PB UTI. Safety was similar between arms: the rate of reported adverse event was 31% (36/116, (95%CI, 25-37%) in FQ-arm versus 36% (28/81, (95%CI, 28-41%)) in FT-arm (RR = 1.17 (95%CI, 0.64-2.15), p = 0.602).
CONCLUSIONS
TRUS-PB UTI prophylaxis with FT and FQ have similar efficacy and safety. A randomized comparison of these two antibiotics is warranted.",2020,"Safety was similar between arms: the rate of reported adverse event was 31% (36/116, (95%CI, 25-37%) in FQ-arm versus 36% (28/81, (95%CI, 28-41%)) in FT-arm (RR = 1.17 (95%CI, 0.64-2.15), p = 0.602).
","['222 men were enrolled, 141/222 (64%) received FQ and 81/222 (36%) FT', 'patients undergoing TRUS-PB', 'Median age was 67.6 years [IQR, 61.4-72.1] and Charlson score 3 [IQR, 3-5', 'Prospective observational study between April-2017 and June-2019, enrolling adults men undergoing TRUS-PB and receiving a single-dose of FQ (FQ-arm) or FT (FT-arm) for UTI prophylaxis as-per physician choice']","['FQ and fosfomycin-trometamol (FT', 'transrectal ultrasound-guided prostate biopsy (TRUS-PB', 'Fosfomycin-trometamol (FT) or fluoroquinolone (FQ']","['Safety', 'incidence of fluoroquinolones (FQ) resistance', 'efficacy and safety', 'overall incidence of self-reported TRUS-PB UTI', 'rate of reported adverse event', 'self-reported TRUS-PB UTI']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C0041175', 'cui_str': 'Tromethamine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C0041175', 'cui_str': 'Tromethamine'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",222.0,0.0822809,"Safety was similar between arms: the rate of reported adverse event was 31% (36/116, (95%CI, 25-37%) in FQ-arm versus 36% (28/81, (95%CI, 28-41%)) in FT-arm (RR = 1.17 (95%CI, 0.64-2.15), p = 0.602).
","[{'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Delory', 'Affiliation': ""APHP, Infectious Diseases and Tropical medicine department, Saint-Louis Hospital, F-75010, Paris, France; Sorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie et de Santé Publique, IPLESP, F75012, Paris, France. Electronic address: delory.tristan@gmail.com.""}, {'ForeName': 'Annabelle', 'Initials': 'A', 'LastName': 'Goujon', 'Affiliation': 'APHP, Urology department, Saint-Louis Hospital, F-75010, Paris, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Masson-Lecomte', 'Affiliation': 'APHP, Urology department, Saint-Louis Hospital, F-75010, Paris, France; APHP, Microbiology department, Saint-Louis Hospital, F-75010, Paris, France; APHP, Pharmacy department, Saint-Louis Hospital, F-75010, Paris, France; Université de Paris.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Arias', 'Affiliation': 'APHP, Microbiology department, Saint-Louis Hospital, F-75010, Paris, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Laurancon-Fretar', 'Affiliation': 'APHP, Infectious Diseases and Tropical medicine department, Saint-Louis Hospital, F-75010, Paris, France.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Bercot', 'Affiliation': 'APHP, Microbiology department, Saint-Louis Hospital, F-75010, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Mongiat-Artus', 'Affiliation': 'APHP, Urology department, Saint-Louis Hospital, F-75010, Paris, France; APHP, Microbiology department, Saint-Louis Hospital, F-75010, Paris, France; APHP, Pharmacy department, Saint-Louis Hospital, F-75010, Paris, France; Université de Paris.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': ""APHP, Infectious Diseases and Tropical medicine department, Saint-Louis Hospital, F-75010, Paris, France; Sorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie et de Santé Publique, IPLESP, F75012, Paris, France; APHP, Urology department, Saint-Louis Hospital, F-75010, Paris, France; APHP, Microbiology department, Saint-Louis Hospital, F-75010, Paris, France; APHP, Pharmacy department, Saint-Louis Hospital, F-75010, Paris, France; Université de Paris.""}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Lafaurie', 'Affiliation': 'APHP, Infectious Diseases and Tropical medicine department, Saint-Louis Hospital, F-75010, Paris, France. Electronic address: matthieu.lafaurie@aphp.fr.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.10.065']
1441,33129989,Cardiovascular Safety and Efficacy of Vadadust for the Treatment of Anemia in Non-Dialysis Dependent CKD: Design and Baseline Characteristics.,"Current clinical practice guidelines for anemia management in non-dialysis dependent chronic kidney disease (NDD-CKD) recommend the use of erythropoiesis-stimulating agents (ESAs) as standard of care. Vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, stimulates endogenous erythropoietin production. The PRO2TECT program comprises two global, Phase 3, randomized, open-label, active-controlled, sponsor-blind clinical trials to evaluate safety and efficacy of vadadustat vs darbepoetin alfa in adult patients with anemia associated with NDD-CKD. Patients recruited into the ESA-untreated NDD-CKD trial (N=1751) had hemoglobin <10 g/dL and had not received an ESA within 8 weeks prior to inclusion in the study. Patients recruited into the ESA-treated NDD-CKD trial (N=1725) had hemoglobin between 8-11 g/dL (US) or 9-12 g/dL (non-US) and were actively treated with an ESA for anemia associated with CKD. Trial periods in both trials include 1) correction/conversion (weeks 0-23); 2) maintenance (weeks 24-52); 3) long-term treatment (week 53 to end of treatment); and 4) safety follow-up (end-of-treatment to 4 weeks later). The primary safety endpoint is time to first adjudicated major adverse cardiovascular event, defined as all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke, pooled across both trials. The primary efficacy endpoint in each trial is change in hemoglobin from baseline to primary evaluation period (weeks 24-36), comparing vadadustat vs darbepoetin alfa treatment groups. Demographics and baseline characteristics were similar among patients in both trials and broadly representative of the NDD-CKD population. These trials will help to evaluate the safety and efficacy of vadadustat for management of anemia associated with NDD-CKD.",2020,"The primary efficacy endpoint in each trial is change in hemoglobin from baseline to primary evaluation period (weeks 24-36), comparing vadadustat vs darbepoetin alfa treatment groups.","['Patients recruited into the ESA-treated NDD-CKD trial (N=1725) had hemoglobin between 8-11 g/dL (US) or 9-12 g/dL (non-US) and were actively treated with an ESA for anemia associated with CKD', 'adult patients with anemia associated with NDD-CKD', 'Anemia in Non-Dialysis Dependent CKD', 'Patients recruited into the ESA-untreated NDD-CKD trial (N=1751) had hemoglobin <10 g/dL and had not received an']","['vadadustat vs darbepoetin alfa', 'ESA', 'erythropoiesis-stimulating agents (ESAs']","['change in hemoglobin', 'time to first adjudicated major adverse cardiovascular event, defined as all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke', 'Cardiovascular Safety and Efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C1318183', 'cui_str': '12G'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C1318182', 'cui_str': '10G'}]","[{'cui': 'C4519730', 'cui_str': 'vadadustat'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1751.0,0.0657826,"The primary efficacy endpoint in each trial is change in hemoglobin from baseline to primary evaluation period (weeks 24-36), comparing vadadustat vs darbepoetin alfa treatment groups.","[{'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA. Electronic address: gchertow@stanford.edu.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Pergola', 'Affiliation': 'Renal Associates PA, San Antonio, TX.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Department of Medicine, Division of Nephrology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'U.S. Renal Care, Plano, TX.'}, {'ForeName': 'Youssef M K', 'Initials': 'YMK', 'LastName': 'Farag', 'Affiliation': 'Akebia Therapeutics, Inc, Cambridge, MA.'}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Jardine', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Koury', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Wenli', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Akebia Therapeutics, Inc, Cambridge, MA.'}, {'ForeName': 'Zeeshan', 'Initials': 'Z', 'LastName': 'Khawaja', 'Affiliation': 'Akebia Therapeutics, Inc, Cambridge, MA.'}, {'ForeName': 'Eldrin F', 'Initials': 'EF', 'LastName': 'Lewis', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Matsushita', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'McCullough', 'Affiliation': 'Baylor University Medical Center, Baylor Scott & White Heart and Vascular Hospital, Dallas, TX.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Parfrey', 'Affiliation': ""Department of Medicine, Memorial University, St John's, Newfoundland, Canada.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wittes', 'Affiliation': 'Unknown affiliation, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Walters', 'Affiliation': 'Unknown affiliation, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Tseng', 'Affiliation': 'Firma Clinical Research, Baltimore, MD.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Firma Clinical Research, Baltimore, MD.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sarnak', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA.'}, {'ForeName': 'Dennis L', 'Initials': 'DL', 'LastName': 'Vargo', 'Affiliation': 'Akebia Therapeutics, Inc, Cambridge, MA.'}, {'ForeName': 'Wolfgang C', 'Initials': 'WC', 'LastName': 'Winkelmayer', 'Affiliation': 'Section of Nephrology, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Kai-Uwe', 'Initials': 'KU', 'LastName': 'Eckardt', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}]",American heart journal,['10.1016/j.ahj.2020.10.068']
1442,33129990,Rationale and Design of the TAILOR-PCI Digital Study: Transitioning a Randomized Controlled Trial to a Digital Registry.,"Background/Introduction: TAILOR-PCI is the largest cardiovascular genotype-based randomized pragmatic trial (NCT#01742117) to evaluate the role of genotype-guided selection of oral P2Y 12 inhibitor therapy in improving ischemic outcomes after percutaneous coronary intervention (PCI). The trial has been extended from the original 12 to 24-month follow-up, using study coordinator-initiated telephone visits. TAILOR-PCI Digital Study tests the feasibility of extending the trial follow-up in a subset of patients for up to 24 months using state-of-the-art digital solutions. The rationale, design, and approach of extended digital study of patients recruited into a large, international, multi-center clinical trial has not been previously described. Methods: A total of 930 patients from U.S. and Canadian sites previously enrolled in the 5,302 patient TAILOR-PCI trial within 23 months of randomization are invited by mail to the Digital Study website (http://tailorpci.eurekaplatform.org) and by up to 2 recruiting telephone calls. Eureka, a direct-to-participant digital research platform, is used to consent and collect prospective data on patients for the digital study. Patients are asked to answer health-related surveys at fixed intervals using the Eureka mobile app and or desktop platform. The likelihood of patients enrolled in a randomized clinical trial transitioning to a registry using digital technology, the reasons for non-participation and engagement rates are evaluated. To capture hospitalizations, patients may optionally enable geofencing, a process that allows background location tracking and triggering of surveys if a hospital visit greater than 4 hours is detected. In addition, patients answer digital hospitalization surveys every month. Hospitalization data received from the Digital Study will be compared to data collected from study coordinator telephone visits during the same time frame. Conclusion: The TAILOR-PCI Digital Study evaluates the feasibility of transitioning a large multicenter randomized clinical trial to a digital registry. The study could provide evidence for the ability of digital technology to follow clinical trial patients and to ascertain trial-related events thus also building the foundation for conducting digital clinical trials. Such a digital approach may be especially pertinent in the era of COVID-19.",2020,The study could provide evidence for the ability of digital technology to follow clinical trial patients and to ascertain trial-related events thus also building the foundation for conducting digital clinical trials.,"['percutaneous coronary intervention (PCI', 'subset of patients for up to 24 months using state-of-the-art digital solutions', 'patients recruited into a large, international, multi-center clinical trial', '930 patients from U.S. and Canadian sites previously enrolled in the 5,302 patient TAILOR-PCI trial within 23 months of randomization are invited by mail to the Digital Study website (http://tailorpci.eurekaplatform.org) and by up to 2 recruiting telephone calls']",['/Introduction'],['ischemic outcomes'],"[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",[],"[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",930.0,0.0692651,The study could provide evidence for the ability of digital technology to follow clinical trial patients and to ascertain trial-related events thus also building the foundation for conducting digital clinical trials.,"[{'ForeName': 'Naveen L', 'Initials': 'NL', 'LastName': 'Pereira', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, 200 Frist Street, SW, Rochester, MN, 55905, United States of America. Electronic address: pereira.naveen@mayo.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Avram', 'Affiliation': 'University of California San Francisco, 505 Parnassus Ave, San Francisco, California, 94143, United States of America.'}, {'ForeName': 'Derek Y', 'Initials': 'DY', 'LastName': 'So', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Iturriaga', 'Affiliation': 'National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health(NIH), Bethesda, MD, United States of America.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, 200 Frist Street, SW, Rochester, MN, 55905, United States of America.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Lennon', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, 200 Frist Street, SW, Rochester, MN, 55905, United States of America.'}, {'ForeName': 'Vishakantha', 'Initials': 'V', 'LastName': 'Murthy', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, 200 Frist Street, SW, Rochester, MN, 55905, United States of America.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Geller', 'Affiliation': 'National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health(NIH), Bethesda, MD, United States of America.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""St. Michael's Hospital, University of Toronto, Toronto, and Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Charanjit', 'Initials': 'C', 'LastName': 'Rihal', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, 200 Frist Street, SW, Rochester, MN, 55905, United States of America.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': 'National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health(NIH), Bethesda, MD, United States of America.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Bailey', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, 200 Frist Street, SW, Rochester, MN, 55905, United States of America.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Pletcher', 'Affiliation': 'University of California San Francisco, 505 Parnassus Ave, San Francisco, California, 94143, United States of America.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Marcus', 'Affiliation': 'University of California San Francisco, 505 Parnassus Ave, San Francisco, California, 94143, United States of America.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Peter\xa0Munk\xa0Cardiac Centre, Toronto, Canada.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Olgin', 'Affiliation': 'University of California San Francisco, 505 Parnassus Ave, San Francisco, California, 94143, United States of America. Electronic address: Jeffrey.olgin@ucsf.edu.'}]",American heart journal,['10.1016/j.ahj.2020.10.069']
1443,33130034,Habitually inactive physically - a proposed procedure of counteracting cognitive decline in women with diminished insulin sensitivity through a high-intensity circuit training program.,"This study verified the impact of five weeks of high-intensity circuit training (HICT) on changes in concentration of exerkines in relation to cognitive functions. Sedentary women (n = 33; age=39±13 years) were randomly assigned into the HICT (n = 21) group or the control group (n = 12). The HICT group performed 15 training sessions; meanwhile, the control group performed the HICT twice, only at baseline and at the end of the experiment. Blood samples were collected before, 1 h and 24 h after the first and last HICT, to evaluate the concentration of exerkines: brain-derived neurotrophic factor (BDNF), irisin, fibroblast growth factor-21 (FGF-21), interleukin-6 (IL-6) and cathepsin B (CATB) using enzyme immunoassay method. Cognitive functions and quality of life were assessed using the Vienna Test System and the Short Form Health Survey. HICT induced improvement of cognitive function and quality of life, and these changes were accompanied by an increase of BDNF and shifts in CATB concentration. HICT program caused a decrease in FGF-21 concentration, which was modified by age and insulin sensitivity. The improvement of cognitive functions was more pronounced in females, who experienced a drop in FGF-21. In summary, HICT program, that can be performed during pandemic, enhanced cognitive functions and this response was related to changes in exerkines.",2020,"HICT induced improvement of cognitive function and quality of life, and these changes were accompanied by an increase of BDNF and shifts in CATB concentration.","['women with diminished insulin sensitivity through a high-intensity circuit training program', 'Sedentary women (n= 33; age=39±13 years']","['high-intensity circuit training (HICT', 'HICT', 'HICT program']","['cognitive function and quality of life', 'factor-21 (FGF-21), interleukin-6 (IL-6) and cathepsin B (CATB', 'cognitive functions', 'concentration of exerkines: brain-derived neurotrophic factor (BDNF), irisin, fibroblast growth', 'FGF-21 concentration', 'Cognitive functions and quality of life', 'BDNF and shifts in CATB concentration']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0699919', 'cui_str': 'Cathepsin B'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0016030', 'cui_str': 'Fibroblast'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]",,0.0217219,"HICT induced improvement of cognitive function and quality of life, and these changes were accompanied by an increase of BDNF and shifts in CATB concentration.","[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Micielska', 'Affiliation': 'Department of Physical Education and Lifelong Sports, Poznan University of Physical Education, Poznan 61-871, Poland; Department of Anatomy and Anthropology, Gdansk University of Physical Education and Sport, Gdansk 80-336, Poland.'}, {'ForeName': 'Jakub Antoni', 'Initials': 'JA', 'LastName': 'Kortas', 'Affiliation': 'Department of Sport, Gdansk University of Physical Education and Sport, Gdansk 80-336, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gmiat', 'Affiliation': 'Department of Physiology, Gdansk University of Physical Education and Sport, Gdansk 80-336, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Jaworska', 'Affiliation': 'Department of Physical Education and Lifelong Sports, Poznan University of Physical Education, Poznan 61-871, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Kozlowska', 'Affiliation': 'Department of Physiology, Gdansk University of Physical Education and Sport, Gdansk 80-336, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lysak-Radomska', 'Affiliation': 'Department of Occupation Therapy, Gdansk University of Physical Education and Sport, Gdansk 80-336, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Rodziewicz-Flis', 'Affiliation': 'Department of Physiotherapy, Gdansk University of Physical Education and Sport, Gdansk 80-336, Poland.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Zychowska', 'Affiliation': 'Institute of Physical Education, Department of Sport, Kazimierz Wielki University in Bydgoszcz, Bydgoszcz 85-064, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Ziemann', 'Affiliation': 'Department of Athletics, Strength and Conditioning, Poznan University of Physical Education, Poznan 61-871, Poland. Electronic address: ziemann@awf.poznan.pl.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113235']
1444,33130093,"Does intensity really matter regarding aerobic exercise reductions in wave reflection and central hemodynamics? Commentary on ""The effect of acute aerobic exercise on central arterial stiffness, wave reflection and hemodynamics in adults with diabetes: A randomized cross-over design"" by Way et al.",,2020,,['adults with diabetes'],['acute aerobic exercise'],"['central arterial stiffness, wave reflection and hemodynamics']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",,0.0689343,,"[{'ForeName': 'Wendell Arthur', 'Initials': 'WA', 'LastName': 'Lopes', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa 87020-900, Brazil; Postgraduate in Physical Education Program, Center of Health Sciences, State University of Maringa, Maringa 87020-900, Brazil; Research Group on Systemic Arterial Hypertension, Arterial Stiffness and Vascular Aging (GPHARV), Maringa, Parana 87020-900, Brazil.'}, {'ForeName': 'João Carlos', 'Initials': 'JC', 'LastName': 'Locatelli', 'Affiliation': 'Postgraduate in Physical Education Program, Center of Health Sciences, State University of Maringa, Maringa 87020-900, Brazil; Research Group on Systemic Arterial Hypertension, Arterial Stiffness and Vascular Aging (GPHARV), Maringa, Parana 87020-900, Brazil. Electronic address: joao17_carlos@hotmail.com.'}, {'ForeName': 'Caroline Ferraz', 'Initials': 'CF', 'LastName': 'Simões', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa 87020-900, Brazil; Postgraduate in Physical Education Program, Center of Health Sciences, State University of Maringa, Maringa 87020-900, Brazil; Research Group on Systemic Arterial Hypertension, Arterial Stiffness and Vascular Aging (GPHARV), Maringa, Parana 87020-900, Brazil.'}, {'ForeName': 'Rogério Toshiro Passos', 'Initials': 'RTP', 'LastName': 'Okawa', 'Affiliation': 'Research Group on Systemic Arterial Hypertension, Arterial Stiffness and Vascular Aging (GPHARV), Maringa, Parana 87020-900, Brazil; Department of Medicine, Center of Health Sciences, State University of Maringa, Maringa 87020-900, Brazil.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.10.008']
1445,33130104,"Evaluating Responses to Gluten Challenge: A Randomized, Double-Blind, 2-Dose Gluten Challenge Trial.","BACKGROUND & AIMS
Gluten challenge is used to diagnose celiac disease (CeD) and for clinical research. Sustained gluten exposure reliably induces histological changes but is burdensome. We investigated the relative abilities of multiple biomarkers to assess disease activity induced by two gluten doses, and aimed to identify biomarkers to supplement or replace histology.
METHODS
In this randomized, double-blind, 2-dose gluten-challenge trial conducted in two US centers (Boston, MA), 14 adults with biopsy-proven CeD were randomized to 3 g or 10 g gluten/day for 14 days. The study was powered to detect changes in villous height:crypt depth (Vh:Cd), and stopped at planned interim analysis on reaching this endpoint. Additional endpoints included gluten-specific cluster of differentiation (CD)4 T-cell analysis with human leukocyte antigen (HLA)-DQ2-gluten tetramers and enzyme-linked immune absorbent spot (ELISpot), gut-homing CD8 T cells, interleukin (IL)-2, symptoms, video capsule endoscopy (VCE), intraepithelial leukocytes (IELs), and tissue multiplex immunofluorescence.
RESULTS
All assessments showed changes with gluten challenge. However, time to maximal change, change magnitude, and gluten dose-response relationship varied. Vh:Cd, VCE enteropathy score, ELISpot, gut-homing CD8 T cells, IEL counts, and HLA-DQ2-restricted gluten-specific CD4 T cells showed significant changes from baseline only at 10 g gluten; symptoms were significant at 3 g. Symptoms and plasma IL-2 levels increased significantly or near significantly at both doses. IL-2 appeared to be the earliest, most sensitive marker of acute gluten exposure.
CONCLUSIONS
Modern biomarkers are sensitive and responsive to gluten exposure, potentially allowing less invasive, lower-dose, shorter-duration gluten ingestion. This work provides a preliminary framework for rational design of gluten challenge for CeD research.",2020,"gut-homing CD8 T cells, interleukin (IL)-2, symptoms, video capsule endoscopy (VCE), intraepithelial leukocytes (IELs), and tissue multiplex immunofluorescence.
","['two US centers (Boston, MA), 14 adults with biopsy-proven CeD']",[],"['plasma IL-2 levels', 'gut-homing CD8 T cells, interleukin (IL)-2, symptoms, video capsule endoscopy (VCE), intraepithelial leukocytes (IELs), and tissue multiplex immunofluorescence', 'Cd, VCE enteropathy score, ELISpot, gut-homing CD8 T cells, IEL counts, and HLA-DQ2-restricted gluten-specific CD4 T cells', 'villous height:crypt depth', 'histological changes', 'gluten-specific cluster of differentiation (CD)4 T-cell analysis with human leukocyte antigen (HLA)-DQ2-gluten tetramers and enzyme-linked immune absorbent spot (ELISpot']","[{'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0016318', 'cui_str': 'Fluorescent identification of anti-nuclear antibody'}, {'cui': 'C0021831', 'cui_str': 'Disorder of intestine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C3873692', 'cui_str': 'Absorbent'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1437174', 'cui_str': 'HLA-DQ2 antigen'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0019629', 'cui_str': 'Class I Histocompatibility Antigens'}]",14.0,0.325024,"gut-homing CD8 T cells, interleukin (IL)-2, symptoms, video capsule endoscopy (VCE), intraepithelial leukocytes (IELs), and tissue multiplex immunofluorescence.
","[{'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Leonard', 'Affiliation': 'Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, Massachusetts; Celiac Disease Research Program, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jocelyn A', 'Initials': 'JA', 'LastName': 'Silvester', 'Affiliation': ""Celiac Disease Research Program, Harvard Medical School, Boston, Massachusetts; Department of Pediatrics, Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Boston, Massachusetts; Celiac Center, Beth Israel Deaconess Medical Center, Boston, Massachusetts.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Leffler', 'Affiliation': 'Celiac Disease Research Program, Harvard Medical School, Boston, Massachusetts; Takeda Pharmaceuticals Inc. Co., Cambridge, Massachusetts.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Fasano', 'Affiliation': 'Center for Celiac Research and Treatment, Massachusetts General Hospital, Boston, Massachusetts; Celiac Disease Research Program, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ciarán P', 'Initials': 'CP', 'LastName': 'Kelly', 'Affiliation': 'Celiac Disease Research Program, Harvard Medical School, Boston, Massachusetts; Celiac Center, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Suzanne K', 'Initials': 'SK', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Goldsmith', 'Affiliation': ""Celiac Disease Research Program, Harvard Medical School, Boston, Massachusetts; Department of Pathology, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Greenblatt', 'Affiliation': 'Invicro, A Konica Minolta Company, Boston, Massachusetts.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Kwok', 'Affiliation': 'Benaroya Research Institute at Virginia Mason, Seattle, Washington.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'McAuliffe', 'Affiliation': 'Takeda Pharmaceuticals Inc. Co., Cambridge, Massachusetts.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Galinsky', 'Affiliation': 'Takeda Pharmaceuticals Inc. Co., Cambridge, Massachusetts.'}, {'ForeName': 'Jenifer', 'Initials': 'J', 'LastName': 'Siegelman', 'Affiliation': 'Takeda Pharmaceuticals Inc. Co., Cambridge, Massachusetts.'}, {'ForeName': 'I-Ting', 'Initials': 'IT', 'LastName': 'Chow', 'Affiliation': 'Benaroya Research Institute at Virginia Mason, Seattle, Washington.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Wagner', 'Affiliation': 'Takeda Pharmaceuticals Inc. Co., Cambridge, Massachusetts.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sapone', 'Affiliation': 'Takeda Pharmaceuticals Inc. Co., Cambridge, Massachusetts.'}, {'ForeName': 'Glennda', 'Initials': 'G', 'LastName': 'Smithson', 'Affiliation': 'Takeda Pharmaceuticals Inc. Co., Cambridge, Massachusetts. Electronic address: glennda.smithson@takeda.com.'}]",Gastroenterology,['10.1053/j.gastro.2020.10.040']
1446,33130107,Effects of Clinic-level Implementation of One Key Question® on Reproductive Health Counseling and Patient Satisfaction.,"OBJECTIVE
We evaluated the effect of clinic level implementation of the One Key Question (OKQ) intervention, including physician and staff training and workflow adjustments, on reproductive counseling and patient satisfaction in primary care and ob/gyn. Study Design We implemented the OKQ intervention in one primary care and one ob/gyn practice, while observing another primary care and ob/gyn practice that each provided usual care (control practices). We surveyed separate patient cohorts at two time points: 26 before and 33 after the primary care practice implemented OKQ, 38 before and 36 after the ob/gyn practice implemented OKQ, 26 and 37 at the primary care control practice, and 31 and 37 at the ob/gyn control practice. We used chi square tests to assess OKQ's effects on counseling rates and patient satisfaction, comparing intervention to control practices across time points.
RESULTS
In primary care, from before to after implementation, the intervention practice did not significantly increase reproductive counseling (69% to 76%, p=.58), but increased patient satisfaction (81% to 97%, p=.04) while the control practice demonstrated a decrease in patient satisfaction over the same time periods. In the ob/gyn clinics, no significant change in reproductive counseling or patient satisfaction was seen in the intervention practice, while the control practice demonstrated a decrease in patient satisfaction.
CONCLUSIONS
Implementing OKQ appears to increase patient satisfaction. Larger studies are needed to assess whether this clinic-level intervention may increase reproductive counseling.
IMPLICATIONS
Further studies of the impact of clinic-level implementation of OKQ are needed.",2020,"In the ob/gyn clinics, no significant change in reproductive counseling or patient satisfaction was seen in the intervention practice, while the control practice demonstrated a decrease in patient satisfaction.
","['surveyed separate patient cohorts at two time points: 26 before and 33 after the primary care practice implemented OKQ, 38 before and 36 after the ob/gyn practice implemented OKQ, 26 and 37 at the primary care control practice, and 31 and 37 at the ob/gyn control practice']","['OKQ intervention in one primary care and one ob/gyn practice, while observing another primary care and ob/gyn practice that each provided usual care (control practices']","['reproductive counseling or patient satisfaction', 'Reproductive Health Counseling and Patient Satisfaction', 'reproductive counseling', 'patient satisfaction']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0474170', 'cui_str': 'Reproductive education'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",,0.0306413,"In the ob/gyn clinics, no significant change in reproductive counseling or patient satisfaction was seen in the intervention practice, while the control practice demonstrated a decrease in patient satisfaction.
","[{'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'Pritzker School of Medicine, University of Chicago, 924 E 57th St, Ste #104 Chicago, IL 60637 USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'White VanGompel', 'Affiliation': 'Pritzker School of Medicine, University of Chicago, 924 E 57th St, Ste #104 Chicago, IL 60637 USA; Department of Family Medicine, University of Chicago, 5841 S Maryland Ave., Chicago, IL 60637 USA; NorthShore University HealthSystem (NSUHS) Research Institute, 1001 University Pl, Evanston, IL 60201 USA.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'NorthShore University HealthSystem (NSUHS) Research Institute, 1001 University Pl, Evanston, IL 60201 USA.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Guzman', 'Affiliation': 'Pritzker School of Medicine, University of Chicago, 924 E 57th St, Ste #104 Chicago, IL 60637 USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Carlock', 'Affiliation': 'NorthShore University HealthSystem (NSUHS) Research Institute, 1001 University Pl, Evanston, IL 60201 USA.'}, {'ForeName': 'Kellie', 'Initials': 'K', 'LastName': 'Schueler', 'Affiliation': 'Pritzker School of Medicine, University of Chicago, 924 E 57th St, Ste #104 Chicago, IL 60637 USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Stulberg', 'Affiliation': 'Pritzker School of Medicine, University of Chicago, 924 E 57th St, Ste #104 Chicago, IL 60637 USA; Department of Family Medicine, University of Chicago, 5841 S Maryland Ave., Chicago, IL 60637 USA. Electronic address: stulberg@uchicago.edu.'}]",Contraception,['10.1016/j.contraception.2020.10.018']
1447,33130139,Single versus double burr hole for drainage of chronic subdural haematoma: A randomized controlled Study.,,2020,,['chronic subdural haematoma'],[],[],"[{'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}]",[],[],,0.20227,,"[{'ForeName': 'Danjuma', 'Initials': 'D', 'LastName': 'Sale', 'Affiliation': 'Department of Surgery, College of Medicine, Kaduna State University, Kaduna Nigeria. Electronic address: doplass@yahoo.com.'}]",World neurosurgery,['10.1016/j.wneu.2020.10.140']
1448,33130147,Variability in Blood Eosinophil Counts in Patients with Eosinophilic Asthma.,"BACKGROUND
Blood eosinophil (EOS) counts are critical to the accurate identification of asthma phenotypes. However, there are few long-term data on intra-individual EOS count variability among patients with eosinophilic asthma.
OBJECTIVE
This post hoc analysis of two phase III clinical trials from the reslizumab BREATH program explored the variability of blood EOS counts in patients with eosinophilic asthma receiving placebo.
METHODS
Pooled data from study participants receiving placebo (previously randomized 1:1 to receive reslizumab or placebo) were analyzed for blood EOS count variability over 52 weeks. EOS counts were measured up to twice during screening, every 4 weeks from randomization to the end of treatment and at the 90-day follow-up visit.
RESULTS
Of 476 included patients, 31 (6.5%), 38 (8.0%), 55 (11.6%) and 352 (73.9%) patients had baseline blood EOS counts of <150 cells/μL, ≥150 to <300 cells/μL, ≥300 to <400 cells/μL and ≥400 cells/μL, respectively. Patients frequently shifted between EOS count categories during the 52-week treatment period, most often moving to the highest EOS category. Among patients in each of the lower three EOS categories, 27 to 56% of patients shifted to the ≥400 cells/μL category at some point during the treatment period.
CONCLUSION
Intra-individual variability in blood EOS count was high among eosinophilic asthma patients receiving placebo, with shifts to ≥400 cells/μL from lower categories frequently observed. Repeat determinations of blood EOS count may be important to ensure appropriate selection of therapy in patients with severe asthma.",2020,"CONCLUSION
Intra-individual variability in blood EOS count was high among eosinophilic asthma patients receiving placebo, with shifts to ≥400 cells/μL from lower categories frequently observed.","['Pooled data from study participants receiving', 'patients with eosinophilic asthma receiving placebo', 'patients with eosinophilic asthma', 'patients with severe asthma', 'Patients with Eosinophilic Asthma', 'eosinophilic asthma patients receiving']","['reslizumab BREATH program', 'reslizumab or placebo', 'placebo']","['EOS counts', 'blood EOS counts', 'Blood Eosinophil Counts', 'blood EOS count', 'blood EOS count variability', 'baseline blood EOS counts']","[{'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034068', 'cui_str': 'Eosinophilic asthma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}]","[{'cui': 'C1869620', 'cui_str': 'reslizumab'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",476.0,0.133089,"CONCLUSION
Intra-individual variability in blood EOS count was high among eosinophilic asthma patients receiving placebo, with shifts to ≥400 cells/μL from lower categories frequently observed.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'David Geffen School of Medicine at University of California, Los Angeles, CA, USA. Electronic address: jcorren@ucla.edu.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Du', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D Inc., West Chester, PA, USA.'}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Gubbi', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D Inc., West Chester, PA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Vanlandingham', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D Inc., West Chester, PA, USA.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.10.033']
1449,33130153,Cognitive Behavior Therapy Tailored to Anxiety Symptoms Improves Pediatric Functional Abdominal Pain Outcomes: A Randomized Clinical Trial.,"OBJECTIVES
To evaluate the feasibility of a stepped care model, and establish the effect of a tailored cognitive behavioral therapy (CBT), the Aim to Decrease Anxiety and Pain Treatment (ADAPT), compared with standard medical treatment as usual on pain-related outcomes and anxiety.
STUDY DESIGN
Eligible patients between the ages of 9 and 14 years with FAPD (n = 139) received enhanced usual care (EUC) during their medical visit to a gastroenterologist. Those that failed to respond to EUC were randomized to receive either a tailored CBT (ADAPT) plus TAU, or TAU only. ADAPT dose (4 sessions of pain management or 6 sessions of pain and anxiety management) was based on presence of clinically significant anxiety. Outcomes included feasibility, based on recruitment and retention rates. Response to ADAPT+TAU versus TAU on pain-related outcomes and anxiety measures was also investigated using a structural equation modeling (SEM) equivalent of a MANCOVA. Anxiety levels and ADAPT dose as moderators of treatment effects were also explored.
RESULTS
Based on recruitment and retention rates, stepped care was feasible. EUC was effective for only 8% of youth. Participants randomized to ADAPT+TAU showed significantly greater improvements in pain-related disability, but not pain levels, and greater improvements in anxiety symptoms compared with those randomized to TAU only. Anxiety and ADAPT treatment dose did not moderate the effect of treatment on disability nor pain.
CONCLUSIONS
Tailoring care based on patient need may be optimal for maximizing the use of limited psychotherapeutic resources while enhancing care.",2020,"Participants randomized to ADAPT+TAU showed significantly greater improvements in pain-related disability, but not pain levels, and greater improvements in anxiety symptoms compared with those randomized to TAU only.",['Eligible patients between the ages of 9 and 14 years with FAPD (n = 139) received'],"['tailored CBT (ADAPT) plus TAU, or TAU only', 'tailored cognitive behavioral therapy (CBT', 'ADAPT+TAU', 'Cognitive Behavior Therapy', 'ADAPT+TAU versus TAU', 'enhanced usual care (EUC', 'EUC']","['pain-related outcomes and anxiety measures', 'Pediatric Functional Abdominal Pain Outcomes', 'pain levels', 'anxiety symptoms', 'disability nor pain', 'feasibility, based on recruitment and retention rates', 'Anxiety levels', 'pain-related disability', 'Anxiety Symptoms', 'Anxiety and Pain Treatment (ADAPT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191072', 'cui_str': '139'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.0698022,"Participants randomized to ADAPT+TAU showed significantly greater improvements in pain-related disability, but not pain levels, and greater improvements in anxiety symptoms compared with those randomized to TAU only.","[{'ForeName': 'Natoshia', 'Initials': 'N', 'LastName': 'Cunningham', 'Affiliation': 'Department of Family Medicine, Michigan State University, Grand Rapids, Michigan. Electronic address: natoshia@msu.edu.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kalomiris', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peugh', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farrell', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Pentiuk', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mallon', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Le', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Moorman', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fussner', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Richa Aggarwal', 'Initials': 'RA', 'LastName': 'Dutta', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Kashikar-Zuck', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.10.060']
1450,33104176,Risk of Electrolyte Disorders in Acutely Ill Children Receiving Commercially Available Plasmalike Isotonic Fluids: A Randomized Clinical Trial.,"Importance
The use of isotonic fluid therapy is currently recommended in children, but there is limited evidence of optimal fluid therapy in acutely ill children.
Objective
To evaluate the risk for electrolyte disorders, including hyponatremia, hypernatremia, and hypokalemia, and the risk of fluid retention in acutely ill children receiving commercially available plasmalike isotonic fluid therapy.
Design, Setting, and Participants
This unblinded, randomized clinical pragmatic trial was conducted at the pediatric emergency department of Oulu University Hospital, Finland, from October 3, 2016, through April 15, 2019. Eligible study subjects (N = 614) were between 6 months and 12 years of age, required hospitalization due to an acute illness, and needed intravenous fluid therapy. Exclusion criteria included a plasma sodium concentration of less than 130 mmol/L or greater than 150 mmol/L on admission; a plasma potassium concentration of less than 3.0 mmol/L on admission; clinical need of fluid therapy with 10% glucose solution; a history of diabetes, diabetic ketoacidosis, or diabetes insipidus; a need for renal replacement therapy; severe liver disease; pediatric cancer requiring protocol-determined chemotherapy hydration; and inborn errors of metabolism. All outcomes and samples size were prespecified except those clearly marked as exploratory post hoc analyses. All analyses were intention to treat.
Interventions
Acutely ill children were randomized to receive commercially available plasmalike isotonic fluid therapy (140 mmol/L of sodium and 5 mmol/L potassium in 5% dextrose) or moderately hypotonic fluid therapy (80 mmol/L sodium and 20 mmol/L potassium in 5% dextrose).
Main Outcomes and Measures
The primary outcome was the proportion of children with any clinically significant electrolyte disorder, defined as hypokalemia less than 3.5 mmol/L, hypernatremia greater than 148 mmol/L, or hyponatremia less than 132 mmol/L during hospitalization due to acute illness. The main secondary outcomes were the proportion of children with severe hypokalemia and weight change.
Results
There were 614 total study subjects (mean [SD] age, 4.0 [3.1] years; 315 children were boys [51%] and all 614 were Finnish speaking [100%]). Clinically significant electrolyte disorder was more common in children receiving plasmalike isotonic fluid therapy (61 of 308 patients [20%]) compared with those receiving moderately hypotonic fluid therapy (9 of 306 patients [2.9%]; 95% CI of the difference, 12%-22%; P < .001). The risk of developing electrolyte disorder was 6.7-fold greater in children receiving isotonic fluid therapy. Hypokalemia developed in 57 patients (19%) and hypernatremia developed in 4 patients (1.3%) receiving plasmalike isotonic fluid therapy. Weight change was greater in children receiving isotonic, plasmalike fluid therapy compared with those receiving mildly hypotonic fluids (mean weight gain, 279 vs 195 g; 95% CI, 16-154 g; P = .02).
Conclusions and Relevance
In this randomized clinical trial, commercially available plasmalike isotonic fluid therapy markedly increased the risk for clinically significant electrolyte disorders, mostly due to hypokalemia, in acutely ill children compared with previously widely used moderately hypotonic fluid therapy containing 20 mmol/L of potassium.
Trial Registration
ClinicalTrials.gov identifier: NCT02926989.",2020,"Weight change was greater in children receiving isotonic, plasmalike fluid therapy compared with those receiving mildly hypotonic fluids (mean weight gain, 279 vs 195 g; 95% CI, 16-154 g; P = .02).
","['children receiving isotonic fluid therapy', 'acutely ill children', 'Exclusion criteria included a plasma sodium concentration of less than 130 mmol/L or greater than 150 mmol/L on admission; a plasma potassium concentration of less than 3.0 mmol/L on admission; clinical need of fluid therapy with 10% glucose solution; a history of diabetes, diabetic ketoacidosis, or diabetes insipidus; a need for renal replacement therapy; severe liver disease; pediatric cancer requiring protocol-determined chemotherapy hydration; and inborn errors of metabolism', 'Eligible study subjects (N\u2009=\u2009614) were between 6 months and 12 years of age, required hospitalization due to an acute illness, and needed intravenous fluid therapy', 'pediatric emergency department of Oulu University Hospital, Finland, from October 3, 2016, through April 15, 2019', 'Interventions\n\n\nAcutely ill children', 'Acutely Ill Children Receiving Commercially Available Plasmalike Isotonic Fluids', 'acutely ill children receiving commercially available plasmalike isotonic fluid therapy', '614 total study subjects (mean [SD] age, 4.0 [3.1] years; 315 children were boys [51%] and all 614 were Finnish speaking [100']","['isotonic fluid therapy', 'plasmalike isotonic fluid therapy', 'commercially available plasmalike isotonic fluid therapy (140 mmol/L of sodium and 5 mmol/L potassium in 5% dextrose) or moderately hypotonic fluid therapy (80 mmol/L sodium and 20 mmol/L potassium in 5% dextrose']","['proportion of children with severe hypokalemia and weight change', 'proportion of children with any clinically significant electrolyte disorder', 'hypernatremia', 'hypokalemia less', 'Hypokalemia', 'Weight change']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0858175', 'cui_str': 'Plasma sodium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0858155', 'cui_str': 'Plasma potassium'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0025521', 'cui_str': 'Inborn error of metabolism'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0985452', 'cui_str': 'Glucose 50 MG/ML'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0342579', 'cui_str': 'Electrolyte imbalance'}, {'cui': 'C0020488', 'cui_str': 'Hypernatremia'}]",315.0,0.349775,"Weight change was greater in children receiving isotonic, plasmalike fluid therapy compared with those receiving mildly hypotonic fluids (mean weight gain, 279 vs 195 g; 95% CI, 16-154 g; P = .02).
","[{'ForeName': 'Saara', 'Initials': 'S', 'LastName': 'Lehtiranta', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Honkila', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Merja', 'Initials': 'M', 'LastName': 'Kallio', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Niko', 'Initials': 'N', 'LastName': 'Paalanne', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Peltoniemi', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Tytti', 'Initials': 'T', 'LastName': 'Pokka', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Marjo', 'Initials': 'M', 'LastName': 'Renko', 'Affiliation': 'Research Unit of Pediatrics, Dermatology, Gynecology, and Obstetrics, Medical Research Center Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Tapiainen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Oulu University Hospital, Oulu, Finland.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.3383']
1451,33104189,Risk of Overcorrection in Rapid Intermittent Bolus vs Slow Continuous Infusion Therapies of Hypertonic Saline for Patients With Symptomatic Hyponatremia: The SALSA Randomized Clinical Trial.,"Importance
Few high-quality studies have clarified whether hypertonic saline is best administered as slow continuous infusion (SCI) therapy or rapid intermittent bolus (RIB) therapy for symptomatic severe hyponatremia.
Objective
To compare the risk of overcorrection in RIB and SCI with hypertonic saline in patients with symptomatic hyponatremia.
Design, Setting, and Participants
This prospective, investigator-initiated, multicenter, open-label, randomized clinical trial enrolled 178 patients older than 18 years with moderately severe to severe hyponatremia and glucose-corrected serum sodium (sNa) levels of 125 mmol/L or less. Recruitment took place from August 24, 2016, until August 21, 2019, across emergency departments and wards of 3 general hospitals in the Republic of Korea.
Interventions
Either RIB or SCI of hypertonic saline, 3%, for 24 to 48 hours stratified by the severity of clinical symptoms.
Main Outcome and Measures
The primary outcome was overcorrection at any given period, defined as increase in the sNa level by greater than 12 or 18 mmol/L within 24 or 48 hours, respectively. Secondary and post hoc outcomes included efficacy and safety of the treatment approaches. The sNa concentrations were measured every 6 hours for 2 days.
Results
The 178 patients (mean [SD] age, 73.1 [12.2] years; 80 (44.9%) male; mean [SD] sNa concentrations, 118.2 [5.0] mmol/L) were randomly assigned to the RIB group (n = 87) or the SCI group (n = 91). Overcorrection occurred in 15 of 87 (17.2%) and 22 of 91 (24.2%) patients in the RIB and SCI groups, respectively (absolute risk difference, -6.9% [95% CI, -18.8% to 4.9%]; P = .26). The RIB group showed lower incidence of relowering treatment than the SCI group (36 of 87 [41.4%] vs 52 of 91 [57.1%] patients, respectively; absolute risk difference, -15.8% [95% CI, -30.3% to -1.3%]; P = .04; number needed to treat, 6.3). Groups did not differ in terms of efficacy in increasing sNa concentrations nor improving symptoms, but RIB, when compared with SCI, showed better efficacy in achieving target correction rate within 1 hour (intention-to-treat analysis: 28 of 87 (32.2%) vs 16 of 91 (17.6%) patients, respectively; absolute risk difference, 14.6% [95% CI, 2%-27.2%]; P = .02; number needed to treat, 6.8; per-protocol analysis: 21 of 72 (29.2%) vs 12 of 73 (16.4%) patients, respectively; absolute risk difference, 12.7% [95% CI, -0.8% to 26.2%]; P = .07). The statistical significance of the intention-to-treat and per-protocol analyses were similar for all outcomes except for achieving the target correction rate within 1 hour.
Conclusions and Relevance
This randomized clinical trial found that both RIB and SIC therapies of hypertonic saline for treating hyponatremia were effective and safe, with no difference in the overcorrection risk. However, RIB had a lower incidence of therapeutic relowering treatment and tended to have a better efficacy in achieving sNa within 1 hour than SCI. RIB could be suggested as the preferred treatment of symptomatic hyponatremia, which is consistent with the current consensus guidelines.
Trial Registration
ClinicalTrials.org Identifier: NCT02887469.",2020,"The statistical significance of the intention-to-treat and per-protocol analyses were similar for all outcomes except for achieving the target correction rate within 1 hour.
","['178 patients older than 18 years with moderately severe to severe hyponatremia and glucose-corrected serum sodium (sNa) levels of 125 mmol/L or less', '178 patients (mean [SD] age, 73.1 [12.2] years; 80 (44.9%) male; mean [SD] sNa concentrations, 118.2 [5.0] mmol/L', 'Patients With Symptomatic Hyponatremia', 'Recruitment took place from August 24, 2016, until August 21, 2019, across emergency departments and wards of 3 general hospitals in the Republic of Korea', 'patients with symptomatic hyponatremia']","['SCI', 'slow continuous infusion (SCI) therapy or rapid intermittent bolus (RIB) therapy', 'Hypertonic Saline', 'hypertonic saline']","['overcorrection at any given period', 'efficacy and safety', 'lower incidence of relowering treatment', 'sNa level', 'sNa concentrations', 'Overcorrection', 'target correction rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0376252', 'cui_str': 'Shona language'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1301695', 'cui_str': 'Intermittent bolus'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}]","[{'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376252', 'cui_str': 'Shona language'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",178.0,0.323637,"The statistical significance of the intention-to-treat and per-protocol analyses were similar for all outcomes except for achieving the target correction rate within 1 hour.
","[{'ForeName': 'Seon Ha', 'Initials': 'SH', 'LastName': 'Baek', 'Affiliation': 'Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Republic of Korea.'}, {'ForeName': 'You Hwan', 'Initials': 'YH', 'LastName': 'Jo', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Soyeon', 'Initials': 'S', 'LastName': 'Ahn', 'Affiliation': 'Medical Research Collaborating Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Kristianne', 'Initials': 'K', 'LastName': 'Medina-Liabres', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Yun Kyu', 'Initials': 'YK', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Bok', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sejoong', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.5519']
1452,33107921,Effect of Electroacupuncture vs Sham Treatment on Change in Pain Severity Among Adults With Chronic Low Back Pain: A Randomized Clinical Trial.,"Importance
Chronic low back pain has high societal and personal impact but remains challenging to treat. Electroacupuncture has demonstrated superior analgesia compared with placebo in animal studies but has not been extensively studied in human chronic pain conditions.
Objective
To evaluate the treatment effect of real electroacupuncture vs placebo in pain and disability among adults with chronic low back pain and to explore psychophysical, affective, and demographic factors associated with response to electroacupuncture vs placebo in treating chronic low back pain.
Design, Setting, and Participants
This double-blind randomized clinical trial was conducted between August 2, 2016, and December 18, 2018, at a single center in Stanford, California. Primary outcomes were collected at approximately 2 weeks before and after intervention. Participants included English-speaking adults with at least 6 months of chronic low back pain, pain intensity of at least 4 on a scale of 0 to 10, and no radiculopathy. Data analyses for this intent-to-treat study were conducted from June 2019 to June 2020.
Interventions
Twelve sessions of real or placebo (sham) electroacupuncture administered twice a week over 6 weeks.
Main Outcomes and Measures
The main outcome was change in pain severity from baseline to 2 weeks after completion of treatment, measured by the National Institutes of Health PROMIS pain intensity scale. A secondary outcome was change in the Roland Morris Disability Questionnaire (RMDQ). Baseline factors potentially associated with these outcomes included psychophysical testing (ie, thermal temporal summation, conditioned pain modulation, pressure pain threshold), participant's self-report (ie, widespread pain, coping strategies, expectations, self-efficacy, and pain catastrophizing), and demographic characteristics (eg, age, sex, and race).
Results
A total of 121 adults were recruited to the study, among whom 59 participants (mean [SD] age, 46.8 [11.9] years; 36 [61.0%] women) were randomized to real electroacupuncture and 62 participants (mean [SD] age, 45.6 [12.8] years; 33 [53.2%] women) were randomized to sham electroacupuncture. At baseline, the mean (SD) PROMIS T-score was 50.49 (3.36) in the real electroacupuncture group and 51.71 (4.70) in the sham acupuncture group, and the mean (SD) RMDQ score was 10.16 (4.76) in the real electroacupuncture group and 10.03 (5.45) in the sham acupuncture group. After adjusting for baseline pain scores, there was no statistically significant difference between groups in change in T-scores 2 weeks after completion of treatment (real electroacupuncture: -4.33; 95% CI, -6.36 to -2.30; sham acupuncture: -2.90; 95% CI, -4.85 to -0.95; difference: -2.09; 95% CI, -4.27 to 0.09; P = .06). After adjusting for baseline RMDQ, there was a significantly greater reduction in RMDQ in the real electroacupuncture group (-2.77; 95% CI, -4.11 to -1.43) compared with the sham electroacupuncture group (-0.67; 95% CI, -1.88 to 0.55; difference: -2.11; 95% CI, -3.75 to -0.47; P = .01). Within the real electroacupuncture group, effective coping at baseline was associated with greater RMDQ reduction (r = -0.32; 95% CI, -0.54 to -0.05; P = .02), and White race was associated with worse outcomes in PROMIS score (β = 3.791; 95% CI, 0.616 to 6.965; P = .02) and RMDQ (β = 2.878; 95% CI, 0.506 to 5.250; P = .02).
Conclusions and Relevance
This randomized clinical trial found no statistically significant difference in change in PROMIS pain score in real electroacupuncture vs sham electroacupuncture. There was a statistically significant treatment effect for the secondary outcome of RMDQ compared with sham electroacupuncture. Effective coping skills and non-White race were associated with response to electroacupuncture.
Trial Registration
ClinicalTrials.gov Identifier: NCT02890810.",2020,"After adjusting for baseline RMDQ, there was a significantly greater reduction in RMDQ in the real electroacupuncture group (-2.77; 95% CI, -4.11 to -1.43) compared with the sham electroacupuncture group (-0.67; 95% CI, -1.88 to 0.55; difference: -2.11; 95% CI, -3.75 to -0.47; P = .01).","['and 62 participants (mean [SD] age, 45.6 [12.8] years; 33 [53.2%] women', 'A total of 121 adults were recruited to the study, among whom 59 participants (mean [SD] age, 46.8 [11.9] years; 36 [61.0%] women', 'Adults With Chronic Low Back Pain', 'Participants included English-speaking adults with at least 6 months of chronic low back pain, pain intensity of at least 4 on a scale of 0 to 10, and no radiculopathy', 'adults with chronic low back pain', 'August 2, 2016, and December 18, 2018, at a single center in Stanford, California']","['Electroacupuncture', 'sham electroacupuncture', 'electroacupuncture vs sham electroacupuncture', 'electroacupuncture', 'real electroacupuncture vs placebo', 'electroacupuncture vs placebo', 'real electroacupuncture', 'placebo', 'acupuncture', 'real or placebo (sham) electroacupuncture']","['mean (SD) PROMIS T-score', 'Pain Severity', 'National Institutes of Health PROMIS pain intensity scale', 'Roland Morris Disability Questionnaire (RMDQ', 'baseline pain scores', ""psychophysical testing (ie, thermal temporal summation, conditioned pain modulation, pressure pain threshold), participant's self-report (ie, widespread pain, coping strategies, expectations, self-efficacy, and pain catastrophizing), and demographic characteristics (eg, age, sex, and race"", 'pain and disability', 'mean (SD) RMDQ score', 'PROMIS pain score', 'RMDQ reduction', 'pain severity', 'RMDQ']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",121.0,0.721707,"After adjusting for baseline RMDQ, there was a significantly greater reduction in RMDQ in the real electroacupuncture group (-2.77; 95% CI, -4.11 to -1.43) compared with the sham electroacupuncture group (-0.67; 95% CI, -1.88 to 0.55; difference: -2.11; 95% CI, -3.75 to -0.47; P = .01).","[{'ForeName': 'Jiang-Ti', 'Initials': 'JT', 'LastName': 'Kong', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Chelcie', 'Initials': 'C', 'LastName': 'Puetz', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Department of Biomedical Data Science, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Haynes', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Eunyoung', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Randall S', 'Initials': 'RS', 'LastName': 'Stafford', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Manber', 'Affiliation': 'Department of Psychiatry, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Mackey', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.22787']
1453,33107945,Effect of Catheter Ablation With Vein of Marshall Ethanol Infusion vs Catheter Ablation Alone on Persistent Atrial Fibrillation: The VENUS Randomized Clinical Trial.,"Importance
Catheter ablation of persistent atrial fibrillation (AF) has limited success. Procedural strategies beyond pulmonary vein isolation have failed to consistently improve results. The vein of Marshall contains innervation and AF triggers that can be ablated by retrograde ethanol infusion.
Objective
To determine whether vein of Marshall ethanol infusion could improve ablation results in persistent AF when added to catheter ablation.
Design, Setting, and Participants
The Vein of Marshall Ethanol for Untreated Persistent AF (VENUS) trial was an investigator-initiated, National Institutes of Health-funded, randomized, single-blinded trial conducted in 12 centers in the United States. Patients (N = 350) with persistent AF referred for first ablation were enrolled from October 2013 through June 2018. Follow-up concluded in June 2019.
Interventions
Patients were randomly assigned to catheter ablation alone (n = 158) or catheter ablation combined with vein of Marshall ethanol infusion (n = 185) in a 1:1.15 ratio to accommodate for 15% technical vein of Marshall ethanol infusion failures.
Main Outcomes and Measures
The primary outcome was freedom from AF or atrial tachycardia for longer than 30 seconds after a single procedure, without antiarrhythmic drugs, at both 6 and 12 months. Outcome assessment was blinded to randomization treatment. There were 12 secondary outcomes, including AF burden, freedom from AF after multiple procedures, perimitral block, and others.
Results
Of the 343 randomized patients (mean [SD] age, 66.5 [9.7] years; 261 men), 316 (92.1%) completed the trial. Vein of Marshall ethanol was successfully delivered in 155 of 185 patients. At 6 and 12 months, the proportion of patients with freedom from AF/atrial tachycardia after a single procedure was 49.2% (91/185) in the catheter ablation combined with vein of Marshall ethanol infusion group compared with 38% (60/158) in the catheter ablation alone group (difference, 11.2% [95% CI, 0.8%-21.7%]; P = .04). Of the 12 secondary outcomes, 9 were not significantly different, but AF burden (zero burden in 78.3% vs 67.9%; difference, 10.4% [95% CI, 2.9%-17.9%]; P = .01), freedom from AF after multiple procedures (65.2% vs 53.8%; difference, 11.4% [95% CI, 0.6%-22.2%]; P = .04), and success achieving perimitral block (80.6% vs 51.3%; difference, 29.3% [95% CI, 19.3%-39.3%]; P < .001) were significantly improved in vein of Marshall-treated patients. Adverse events were similar between groups.
Conclusions and Relevance
Among patients with persistent AF, addition of vein of Marshall ethanol infusion to catheter ablation, compared with catheter ablation alone, increased the likelihood of remaining free of AF or atrial tachycardia at 6 and 12 months. Further research is needed to assess longer-term efficacy.
Trial Registration
ClinicalTrials.gov Identifier: NCT01898221.",2020,"At 6 and 12 months, the proportion of patients with freedom from AF/atrial tachycardia after a single procedure was 49.2% (91/185) in the catheter ablation combined with vein of Marshall ethanol infusion group compared with 38% (60/158) in the catheter ablation alone group (difference, 11.2% [95% CI, 0.8%-21.7%];","['343 randomized patients (mean [SD] age, 66.5 [9.7] years; 261 men), 316 (92.1%) completed the trial', 'Participants\n\n\nThe Vein of Marshall Ethanol for Untreated Persistent AF (VENUS) trial was an investigator-initiated, National Institutes of Health-funded, randomized, single-blinded trial conducted in 12 centers in the United States', 'patients with persistent AF', 'Persistent Atrial Fibrillation', 'persistent atrial fibrillation (AF', 'Patients (N\u2009=\u2009350) with persistent AF referred for first ablation were enrolled from October 2013 through June 2018']","['catheter ablation alone', 'Catheter Ablation Alone', 'Vein of Marshall Ethanol Infusion vs', 'Catheter Ablation', 'Vein of Marshall ethanol', 'catheter ablation alone (n\u2009=\u2009158) or catheter ablation combined with vein of Marshall ethanol infusion (n\u2009=\u2009185) in a 1:1.15 ratio to accommodate for 15% technical vein of Marshall ethanol infusion failures', 'catheter ablation combined with vein of Marshall ethanol infusion', 'vein of Marshall ethanol infusion']","['AF burden, freedom from AF after multiple procedures, perimitral block, and others', 'success achieving perimitral block', 'Adverse events', 'proportion of patients with freedom from AF/atrial tachycardia', 'likelihood of remaining free of AF or atrial tachycardia', 'freedom from AF or atrial tachycardia', 'AF burden']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",343.0,0.20786,"At 6 and 12 months, the proportion of patients with freedom from AF/atrial tachycardia after a single procedure was 49.2% (91/185) in the catheter ablation combined with vein of Marshall ethanol infusion group compared with 38% (60/158) in the catheter ablation alone group (difference, 11.2% [95% CI, 0.8%-21.7%];","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Valderrábano', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas.'}, {'ForeName': 'Leif E', 'Initials': 'LE', 'LastName': 'Peterson', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Swarup', 'Affiliation': 'Arizona Heart Rhythm Center, Phoenix.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Schurmann', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Makkar', 'Affiliation': 'Arizona Heart Rhythm Center, Phoenix.'}, {'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Doshi', 'Affiliation': 'Keck-USC University Hospital, University of Southern California, Los Angeles.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'DeLurgio', 'Affiliation': ""Emory St Joseph's Hospital, Emory University, Atlanta, Georgia.""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Athill', 'Affiliation': 'Sharp Memorial Hospital, San Diego, California.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Ellenbogen', 'Affiliation': 'Virginia Commonwealth University School of Medicine, Richmond.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Natale', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St David's Medical Center, Austin.""}, {'ForeName': 'Jayanthi', 'Initials': 'J', 'LastName': 'Koneru', 'Affiliation': 'Virginia Commonwealth University School of Medicine, Richmond.'}, {'ForeName': 'Amish S', 'Initials': 'AS', 'LastName': 'Dave', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas.'}, {'ForeName': 'Irakli', 'Initials': 'I', 'LastName': 'Giorgberidze', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Afshar', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Guthrie', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Bunge', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Morillo', 'Affiliation': 'Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Neal S', 'Initials': 'NS', 'LastName': 'Kleiman', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas.'}]",JAMA,['10.1001/jama.2020.16195']
1454,33105245,Preoperative dexamethasone for pain relief after total knee arthroplasty: A randomised controlled trial.,"BACKGROUND
Corticosteroids can reduce pain but the optimal dose and safety profiles are still uncertain.
OBJECTIVE
This study aimed to evaluate two different doses of dexamethasone for pain management and their side effects after total knee arthroplasty.
DESIGN
A prospective randomised, controlled trial.
SETTING
A tertiary teaching hospital in Hong Kong.
PATIENTS
One hundred and forty-six patients were randomly allocated to one of three study groups.
INTERVENTIONS
Before operation, patients in group D8, D16 and P received dexamethasone 8 mg, dexamethasone 16 mg and placebo (0.9% saline), respectively.
MAIN OUTCOME MEASURES
The primary outcome was postoperative pain score. Secondary outcomes were opioid consumption, physical parameters of the knees and side effects of dexamethasone.
RESULTS
Compared with placebo, group D16 patients had significantly less pain during maximal active flexion on postoperative day 3 [-1.3 (95% CI, -2.2 to -0.31), P = 0.005]. There was also a significant dose-dependent trend between pain scores and dexamethasone dose (P = 0.002). Compared with placebo, patients in group D16 consumed significantly less opioid [-6.4 mg (95% CI, -11.6 to -1.2), P = 0.025] and had stronger quadriceps power on the first three postoperative days (all P < 0.05). They also had significantly longer walking distance on postoperative day 1 [7.8 m ([95% CI, 0.85 to 14.7), P = 0.023] with less assistance during walking on the first two postoperative days (all P < 0.029) and significantly better quality-of-recovery scores on postoperative day 1 (P = 0.018). There were significant dose-dependent trends between all the above parameters and dexamethasone dose (all P < 0.05). No significant differences were found in the incidence of chronic pain or knee function 3, 6 and 12 months postoperatively.
CONCLUSION
Dexamethasone 16 mg given before total knee arthroplasty led to a reduction in postoperative pain, less opioid consumption, stronger quadriceps muscle power, better mobilisation and better overall quality-of-recovery after operation. No long-term improvement in reduction in pain and function of the knee was found.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT02767882.",2020,"Compared with placebo, group D16 patients had significantly less pain during maximal active flexion on postoperative day 3","['One hundred and forty-six patients', 'pain relief after total knee arthroplasty', 'A tertiary teaching hospital in Hong Kong', 'total knee arthroplasty']","['dexamethasone', 'Dexamethasone', 'placebo', 'dexamethasone 8\u200amg, dexamethasone 16\u200amg and placebo', 'Preoperative dexamethasone']","['longer walking distance', 'opioid consumption, physical parameters of the knees and side effects of dexamethasone', 'quality-of-recovery scores', 'pain', 'chronic pain or knee function', 'postoperative pain, less opioid consumption, stronger quadriceps muscle power, better mobilisation and better overall quality-of-recovery', 'pain and function of the knee', 'pain during maximal active flexion', 'pain scores', 'postoperative pain score']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",146.0,0.535529,"Compared with placebo, group D16 patients had significantly less pain during maximal active flexion on postoperative day 3","[{'ForeName': 'Timmy Chi Wing', 'Initials': 'TCW', 'LastName': 'Chan', 'Affiliation': 'From the Department of Anaesthesiology, Queen Mary Hospital (TCWC, AYFC), Department of Anaesthesiology, University of Hong Kong (CWC, SSCW, MGI), Department of Orthopaedics and Traumatology, Queen Mary Hospital (PKC, HF), Department of Orthopaedics and Traumatology, University of Hong Kong, Hong Kong, China (CHY, KYC).'}, {'ForeName': 'Chi Wai', 'Initials': 'CW', 'LastName': 'Cheung', 'Affiliation': ''}, {'ForeName': 'Stanley Sau Ching', 'Initials': 'SSC', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Arthur Yu Fai', 'Initials': 'AYF', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Irwin', 'Affiliation': ''}, {'ForeName': 'Ping Keung', 'Initials': 'PK', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Chun Hoi', 'Initials': 'CH', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Kwong Yuen', 'Initials': 'KY', 'LastName': 'Chiu', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001372']
1455,33105246,"Differential lung ventilation assessed by electrical impedance tomography in ultrasound-guided anterior suprascapular nerve block vs. interscalene brachial plexus block: A patient and assessor-blind, randomised controlled trial.","BACKGROUND
Ultrasound-guided interscalene brachial plexus block (ISB) is used to control pain after shoulder surgery. Though effective, drawbacks include phrenic nerve block and motor block of the hand. The ultrasound-guided anterior approach to perform suprascapular nerve block (SSNB) may provide a good alternative.
OBJECTIVE
To compare lung ventilation and diaphragmatic activity on the operated side in ISB and SSNB.
DESIGN
Randomised, controlled patient-blinded and assessor-blinded trial.
SETTING
Outpatient surgical clinic with recruitment from June 2017 to January 2018.
PATIENTS
Fifty-five outpatients scheduled for arthroscopic shoulder surgery were allocated randomly to receive SSNB or ISB. Technical problems with monitoring devices unrelated to the intervention led to exclusion of seven patients. The remaining 48 (n=24 in each group) were followed up for 24 h without drop-outs.
INTERVENTIONS
Patients received 10 ml of ropivacaine 1.0% wt/vol for both procedures.
OUTCOME MEASURES
Percentage lung ventilation on the operated side was the primary endpoint as assessed with electrical impedance tomography (EIT). Secondary endpoints were hemidiaphragmatic motion on the operated side, pain, opioid use, hand strength and numbness, and patient satisfaction.
RESULTS
Before regional anaesthesia, the lung on the operated side contributed a median [IQR] of 50 [42 to 56]% of the total lung ventilation. Postoperatively, it was 40 [3 to 50]% (SSNB) vs. 3 [1 to 13]% (ISB) for an adjusted difference of 23 (95% CI, 13 to 34)%, (P < 0.001). Hemidiaphragmatic motion was 1.90 (95% CI, 1.37 to 2.44 cm), (P < 0.001) lower in the ISB group compared with the SSNB group. Hand strength was 11.2 (95% CI 3.6 to 18.9), (P = 0.0024) kg greater for SSNB and numbness was observed in 0% (SSNB) vs. 46% (ISB) of patients, P < 0.001. Pain was low in the first 6 h after surgery in both groups with slightly, but not significantly, lower values for ISB. No meaningful or significant differences were found for opioid use or patient satisfaction.
CONCLUSION
An ultrasound-guided anterior approach to SSNB preserves ipsilateral lung ventilation and phrenic function better than a standard ISB.
TRIAL REGISTRATION
drks.de identifier: DRKS00011787.",2020,"Hand strength was 11.2 (95% CI 3.6 to 18.9), (P = 0.0024) kg greater for SSNB and numbness was observed in 0% (SSNB) vs. 46% (ISB) of patients, P < 0.001.","['Fifty-five outpatients scheduled for arthroscopic shoulder surgery', 'Outpatient surgical clinic with recruitment from June 2017 to January 2018']","['SSNB or ISB', 'Ultrasound-guided interscalene brachial plexus block (ISB', 'ultrasound-guided anterior approach to perform suprascapular nerve block (SSNB', 'Differential lung ventilation assessed by electrical impedance tomography in ultrasound-guided anterior suprascapular nerve block vs. interscalene brachial plexus block', 'ropivacaine 1.0%\u200awt/vol for both procedures']","['Hand strength', 'hemidiaphragmatic motion on the operated side, pain, opioid use, hand strength and numbness, and patient satisfaction', 'electrical impedance tomography (EIT', 'lung ventilation and diaphragmatic activity', 'Pain', 'ipsilateral lung ventilation and phrenic function', 'opioid use or patient satisfaction', 'Hemidiaphragmatic motion', 'SSNB and numbness']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0559305', 'cui_str': 'Differential lung ventilation'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0242959', 'cui_str': 'Hand Strength'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}]",55.0,0.14646,"Hand strength was 11.2 (95% CI 3.6 to 18.9), (P = 0.0024) kg greater for SSNB and numbness was observed in 0% (SSNB) vs. 46% (ISB) of patients, P < 0.001.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Petroff', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wiegel', 'Affiliation': ''}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Pech', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Salz', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mrongowius', 'Affiliation': ''}, {'ForeName': 'Andreas W', 'Initials': 'AW', 'LastName': 'Reske', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001367']
1456,33109233,Effect of body mass index on response to neo-adjuvant therapy in HER2-positive breast cancer: an exploratory analysis of the NeoALTTO trial.,"BACKGROUND
Obesity is a risk factor for breast cancer (BC) development, recurrence, and death. In view of this, we aimed to investigate the clinical value of obesity in BC patients treated with anti-HER2 therapies in the NeoALTTO trial, which randomized 455 patients to neo-adjuvant lapatinib, trastuzumab, or their combination plus paclitaxel.
METHODS
Patients were classified according to their basal body mass index (BMI) into underweight (< 18.5 kg/m 2 ), normal (≥ 18.5; < 25 kg/m 2 ), overweight (≥ 25; < 30 kg/m 2 ), and obese (≥ 30 kg/m 2 ) WHO categories. Univariate and multivariate logistic regression analyses were performed using BMI as a categorical variable. Pathological complete response (pCR) and event-free survival (EFS) were the NeoALTTO primary and secondary outcomes, respectively.
RESULTS
Among 454 patients analyzed, 14 (3%), 220 (48%), 137 (30%), and 83 (18%) were classified as underweight, normal weight, overweight, and obese, respectively; 231 (51%) and 223 (49%) had hormone receptor (HR)-positive and HR-negative primary tumors; 160 (35%) achieved pCR. In the overall patient population, no association was found between BMI groups and pCR, as we reported pCR rates of 57.1%, 35%, 30.7%, and 39.8% in underweight, normal weight, overweight, and obese cases, respectively. In contrast, in HR-positive tumors, overweight or obesity was generally associated with decreased likelihood of achieving a pCR independently of other clinical variables, including planned surgery, nodal status, and tumor size (odds ratio [OR] = 0.55, 95%CI 0.30-1.01, as compared to normal or underweight; p = 0.053); notably, no differential effect of BMI with respect to pCR was observed in HR-negative cases (odds ratio [OR] = 1.30, 95%CI 0.76-2.23, as compared to normal or underweight; p = 0.331), resulting in a statistically significant interaction between BMI and HR status (p = 0.036). There was no association between BMI and EFS neither in the overall nor in the HR-positive population, but this analysis was under-powered.
CONCLUSIONS
NeoALTTO patients overweight or obese at baseline and with HR-positive primary BC appeared less likely to achieve pCR after neo-adjuvant anti-HER2 therapies. This finding paves the way to future research in targeting the interplay between HER2/HR signaling and metabolism.",2020,"There was no association between BMI and EFS neither in the overall nor in the HR-positive population, but this analysis was under-powered.
","['Patients were classified according to their basal body mass index (BMI) into underweight (<\u200918.5\u2009kg/m 2 ), normal (≥\u200918.5; <\u200925\u2009kg/m 2 ), overweight (≥\u200925; <\u200930\u2009kg/m 2 ), and obese (≥\u200930\u2009kg/m 2 ) WHO categories', 'HER2-positive breast cancer', 'BC patients treated with', '455 patients to neo-adjuvant']","['anti-HER2 therapies', 'lapatinib, trastuzumab, or their combination plus paclitaxel', 'pCR', 'body mass index']","['planned surgery, nodal status, and tumor size', 'pCR', 'BMI and HR status', 'Pathological complete response (pCR) and event-free survival (EFS', 'BMI and EFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C3536735', 'cui_str': 'Basal Body'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0449443', 'cui_str': 'Receptor status'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",455.0,0.069468,"There was no association between BMI and EFS neither in the overall nor in the HR-positive population, but this analysis was under-powered.
","[{'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Di Cosimo', 'Affiliation': 'Biomarkers Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale dei Tumori, via G.A. Amadeo 42, 20133, Milano, Italy. serena.dicosimo@istitutotumori.mi.it.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Porcu', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Department of Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Agbor-Tarh', 'Affiliation': 'Frontier Science (Scotland) Ltd, Kincraig, UK.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'San Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Maria Alice', 'Initials': 'MA', 'LastName': 'Franzoi', 'Affiliation': ""Institut Jules Bordet and l'Universitè Libre de Bruxelles (U.LB), Brussels, Belgium.""}, {'ForeName': 'Maria Carmen', 'Initials': 'MC', 'LastName': 'De Santis', 'Affiliation': 'Radiation Oncology, Fondazione IRSCCS Istituto Nazionale dei Tumori, Milano, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'University of Ulm, Ulm, Germany.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Fumagalli', 'Affiliation': 'Breast International Group (BIG), Boulevard de Waterloo 76, 1000, Bruxelles, Belgium.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Oncology Clinical Development, Oncology Business Unit, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': ""Institut Jules Bordet and l'Universitè Libre de Bruxelles (U.LB), Brussels, Belgium.""}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Daidone', 'Affiliation': 'Biomarkers Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale dei Tumori, via G.A. Amadeo 42, 20133, Milano, Italy.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': ""Institut Jules Bordet and l'Universitè Libre de Bruxelles (U.LB), Brussels, Belgium.""}]",Breast cancer research : BCR,['10.1186/s13058-020-01356-w']
1457,33109663,Effects of oil-soluble versus water-soluble contrast media at hysterosalpingography on pregnancy outcomes in women with a low risk of tubal disease: study protocol for a randomised controlled trial.,"INTRODUCTION
In recent years, due to various factors, the rate of infertility in China has increased and now affects over 10% of women of reproductive age. Hysterosalpingography (HSG) is a common diagnostic procedure during fertility examinations. However, there is no consensus on the choice of contrast agents and their effects. As the largest multicentre, randomised controlled trial (H2Oil trial from the Netherlands) has shown that oil-soluble contrast at HSG can enhance fertility compared with water-soluble contrast, we propose this study to examine whether the use of oil-soluble contrast media results in increased rates of pregnancy in Chinese women undergoing HSG.
METHODS AND ANALYSIS
This study is a single-centre, randomised, controlled, parallel-group, superiority trial. Patients with low risk of tubal disease will be randomised to undergo HSG using iodinated oil injection (OSCM group, oil-soluble contrast media) or ioversol injection (WSCM group, water-soluble contrast media). To evaluate the potential superiority of the OSCM group, with 1:1 allocation ratio, 90% statistical power and a two-sided significance level of 5%, we have calculated a sample of 520 women per group to be enrolled, for a total of 1040 including 10% loss to follow-up or protocol variation. The primary outcome is the rate of ongoing pregnancy during 6 months after randomisation. The secondary outcomes will consist of thyroid function of patients and newborns, pain scores during HSG, rate of live birth, clinical pregnancies, miscarriages, ectopic pregnancy, time to ongoing pregnancy, time to live birth, cost calculations of the OSCM group/WSCM group, and assisted reproductive technology treatments between the two groups.
ETHICS AND DISSEMINATION
This protocol received authorisation from the Medical Research Ethics Committee of International Peace Maternity and Child Health Hospital on 18 January 2020 (approval no GKLW2020-02). The findings will be reported in peer-reviewed publications and presentations at international scientific meetings.
TRIAL REGISTRATION NUMBER
ChiCTR2000031612.",2020,"In recent years, due to various factors, the rate of infertility in China has increased and now affects over 10% of women of reproductive age.","['Patients with low risk of tubal disease', '520 women per group to be enrolled, for a total of 1040 including 10% loss to follow-up or protocol variation', 'women with a low risk of tubal disease', 'Chinese women undergoing HSG']","['oil-soluble versus water-soluble contrast media at hysterosalpingography', 'HSG using iodinated oil injection (OSCM group, oil-soluble contrast media) or ioversol injection (WSCM group, water-soluble contrast media', 'OSCM', 'Hysterosalpingography (HSG']","['rate of ongoing pregnancy', 'pregnancy outcomes', 'rates of pregnancy', 'thyroid function of patients and newborns, pain scores during HSG, rate of live birth, clinical pregnancies, miscarriages, ectopic pregnancy, time to ongoing pregnancy, time to live birth, cost calculations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0444757', 'cui_str': 'Water soluble contrast medium'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0063828', 'cui_str': 'ioversol'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0032987', 'cui_str': 'Ectopic pregnancy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}]",,0.288178,"In recent years, due to various factors, the rate of infertility in China has increased and now affects over 10% of women of reproductive age.","[{'ForeName': 'Guiling', 'Initials': 'G', 'LastName': 'Liang', 'Affiliation': 'Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Key Laboratory Embryo Original Diseases, Shanghai, China.'}, {'ForeName': 'Chenfeng', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhaoxia', 'Initials': 'Z', 'LastName': 'Qian', 'Affiliation': 'Shanghai Key Laboratory Embryo Original Diseases, Shanghai, China zhaoxiaqian@163.com zhangjian_sjtu@126.com.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China zhaoxiaqian@163.com zhangjian_sjtu@126.com.'}]",BMJ open,['10.1136/bmjopen-2020-039166']
1458,33112004,"Footbath as a safe, simple, and non-pharmacological method to improve sleep quality of menopausal women.","Due to the adverse effects of medication we decided to provide a safe, economic, and easy intervention to decrease sleep problems in menopausal women. This trial aimed to determine the effect of footbath on sleep disturbance in postmenopausal women. One hundred menopausal women were randomly stratified using a permuted block randomization procedure by Random Allocation Software, and assigned to one of two study groups: control (without intervention, n = 50) and intervention (footbath, n = 50). The footbath group was asked to lie their feet into the warm water for 20 min in a container with a depth of 10 cm one hour before the usual sleeping time for 6 weeks. To assess sleep quality, we used the Pittsburgh sleep quality index (PSQI). To evaluate severity of menopause symptoms, the Greene scale was applied. Before the intervention, 96% of the subjects in the footbath group and 94% in the control group were poor sleepers. The results of analysis of covariance showed significant improvement in sleep quality and decrease in severity of menopause signs in the footbath group compared to the control group. At the baseline, there was a statistically significant correlation between the severity of menopause signs and the global score of PSQI in all study individuals (p ≤ .001, r = .464). The present study findings showed that footbath intervention enhanced sleep quality in menopausal women. Thus, footbath as a safe, simple, and non-pharmacological application can improve quality of life in postmenopausal women and inhibit problems due to inadequate sleep quality.",2020,"At the baseline, there was a statistically significant correlation between the severity of menopause signs and the global score of PSQI in all study individuals (p ≤ .001,","['One hundred menopausal women', 'menopausal women', 'postmenopausal women']","['control (without intervention, n\u2009=\u200950) and intervention (footbath, n\u2009=\u200950', 'footbath', 'footbath intervention', 'Footbath']","['severity of menopause signs', 'sleep problems', 'severity of menopause signs and the global score of PSQI', 'sleep disturbance', 'quality of life', 'Pittsburgh sleep quality index (PSQI', 'sleep quality']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",100.0,0.0295432,"At the baseline, there was a statistically significant correlation between the severity of menopause signs and the global score of PSQI in all study individuals (p ≤ .001,","[{'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Aghamohammadi', 'Affiliation': 'Department of Nutrition, Khalkhal University of Medical sciences, Khalkhal, Iran.'}, {'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Salmani', 'Affiliation': 'Department of Midwifery, Khalkhal University of Medical sciences, Khalkhal, Iran.'}, {'ForeName': 'Reyhaneh', 'Initials': 'R', 'LastName': 'Ivanbagha', 'Affiliation': 'Department of Midwifery, Khalkhal University of Medical sciences, Khalkhal, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Effati Daryani', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Nasiri', 'Affiliation': 'Department of Medical-Surgical Nursing, Khalkhal University of Medical sciences, Khalkhal, Iran.'}]",Research in nursing & health,['10.1002/nur.22082']
1459,31700099,The shape of disposable diaper affects spontaneous movements of lower limbs in young infants.,"This study examined the characteristics of young infants' lower limb spontaneous movements based on differences in shape of diapers. Twenty-seven healthy infants (103 ± 16.3 days old) were enrolled in this study. We measured the spontaneous movements of their lower limbs in four conditions (Naked, wearing Normal type diapers, wearing Type A diapers, and wearing Type B diapers). The Normal diaper has a wider waist belt than the Type A diaper, and the Type B diaper has a narrower crotch area than the Type A diaper. We observed them in seven indices (the velocity of lower limb movements, the trajectory area of knee movement in the sagittal plane and the frontal plane, the distance between both knees and between side of abdomen and knee, and correlation of velocities between side of abdomen and knee and between left and right ankles). The results showed that the velocity of the lower limb movements in the Naked condition was higher than when wearing Normal diapers. The value for the trajectory area of knee movement in sagittal plane, which reflects the range of lower leg lifting movements and closeness of such movements to the trunk, for the Type B diaper condition was higher than that for the Normal diaper condition. This result indicates that the shape of the diaper affects the spontaneous movements of the lower limbs of young infants.",2019,The results showed that the velocity of the lower limb movements in the Naked condition was higher than when wearing Normal diapers.,"['Twenty-seven healthy infants (103\u2009±\u200916.3 days old', 'young infants']",[],['velocity of the lower limb movements'],"[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],"[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",27.0,0.0344084,The results showed that the velocity of the lower limb movements in the Naked condition was higher than when wearing Normal diapers.,"[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Gima', 'Affiliation': 'Child Developmental and Learning Research Center, Faculty of Regional Sciences, Tottori University, 4-101 Koyama-Minami, Tottori, 680-8551, Japan.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Teshima', 'Affiliation': 'Global Research & Development Division, Unicharm Corporation, 1531-7 Wadahama, Toyohama-cho, Kanonji, Kagawa, 769-1602, Japan.'}, {'ForeName': 'Etsuko', 'Initials': 'E', 'LastName': 'Tagami', 'Affiliation': 'Global Research & Development Division, Unicharm Corporation, 1531-7 Wadahama, Toyohama-cho, Kanonji, Kagawa, 769-1602, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Global Research & Development Division, Unicharm Corporation, 1531-7 Wadahama, Toyohama-cho, Kanonji, Kagawa, 769-1602, Japan.'}, {'ForeName': 'Hidenobu', 'Initials': 'H', 'LastName': 'Ohta', 'Affiliation': 'Department of Pyschophysiology, National Institute of Mental Health, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-higashi-cho, Kodaira, Tokyo, 187-8553, Japan. hideohta@med.akita-u.ac.jp.'}]",Scientific reports,['10.1038/s41598-019-52471-4']
1460,33118519,[Effect of ozone oil for prevention and treatment of sorafenib-induced hand-foot skin reactions: a randomized controlled trial].,"OBJECTIVE
To compare the effects of medical ozone oil and urea ointment for prevention and treatment of hand-foot skin reaction (HFSR) caused by sorafenib in patients with hepatocellular carcinoma (HCC).
METHODS
A total of 99 patients diagnosed with advanced HCC according to National Comprehensive Cancer Network (NCCN) who were scheduled to receive sorafenib treatment for the first time were enrolled in this study between April, 2018 and January, 2020. The patients were randomized into medical ozone oil group ( n =49) and urea ointment group (control group, n =49) for treatment with local application of 1 mL medical ozone oil (experimental group) and 10% urea ointment (2 g) on the palm and plantar skin (including the fingers and joints) for 12 weeks (3 times per day) starting at the beginning of sorafenib treatment, respectively. The patients were observed for occurrence of HFSR every 2 weeks for 14 weeks.
RESULTS
Eight patients were excluded for poor compliance or protocol violations, leaving a total of 91 patients for analysis, including 44 in medical ozone oil group and 47 in urea ointment group. Sixteen (36.4%) of patients in ozone oil group developed HFSR, a rate significantly lower than that in urea ointment group (57.4%; P < 0.05). The incidence of grade 2/3 HFSR was also lower in ozone oil group than in urea ointment group (15.9% [7/44] vs 27.7 [13/47]).
CONCLUSIONS
Medical ozone oil can significantly reduce the incidence and severity of HFSR to improve the quality of life of HCC patients receiving sorafenib treatment.",2020,"The incidence of grade 2/3 HFSR was also lower in ozone oil group than in urea ointment group (15.9% [7/44] vs 27.7 [13/47]).
","['99 patients diagnosed with advanced HCC according to National Comprehensive Cancer Network (NCCN) who were scheduled to receive sorafenib treatment for the first time were enrolled in this study between April, 2018 and January, 2020', 'Eight patients were excluded for poor compliance or protocol violations, leaving a total of 91 patients for analysis, including 44 in medical ozone oil group and 47 in urea ointment group', 'patients with hepatocellular carcinoma (HCC', 'induced hand-foot skin reactions']","['ozone oil', 'medical ozone oil and urea ointment', 'urea ointment group (control group, n =49) for treatment with local application of 1 mL medical ozone oil (experimental group) and 10% urea ointment (2 g) on the palm and plantar skin', 'sorafenib', 'medical ozone oil']","['quality of life', 'incidence of grade 2/3 HFSR', 'HFSR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]","[{'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",99.0,0.0335755,"The incidence of grade 2/3 HFSR was also lower in ozone oil group than in urea ointment group (15.9% [7/44] vs 27.7 [13/47]).
","[{'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Liver Cancer Center, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Yiyue', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Liver Cancer Center, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Liver Cancer Center, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Wencong', 'Initials': 'W', 'LastName': 'Dai', 'Affiliation': 'Liver Cancer Center, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Fan', 'Affiliation': 'Liver Cancer Center, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Xie', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'Cancer Center, Hospital of Integrated Traditional and Western Medicine, Southern Medical University, Guangzhou 510310, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'Liver Cancer Center, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Yan', 'Affiliation': 'Cancer Center, Hospital of Integrated Traditional and Western Medicine, Southern Medical University, Guangzhou 510310, China.'}, {'ForeName': 'Yabing', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Liver Cancer Center, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.'}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.12122/j.issn.1673-4254.2020.10.15']
1461,33118602,"Ingestion of a THC-Rich Cannabis Oil in People with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.","OBJECTIVE
To determine the benefit of a tetrahydrocannabinol (THC)-rich cannabis oil on symptoms and quality of life of fibromyalgia patients.
METHODS
A double-blind, randomized, placebo-controlled clinical trial was conducted for eight weeks to determine the benefit of a THC-rich cannabis oil (24.44 mg/mL of THC and 0.51 mg/mL of cannabidiol [CBD]) on symptoms and quality of life of 17 women with fibromyalgia, residents of a neighborhood with a low socioeconomic profile and a high incidence of violence in the city of Florianopolis, Brazil. The initial dose was one drop (∼1.22 mg of THC and 0.02 mg of CBD) a day with subsequent increases according to symptoms. The Fibromyalgia Impact Questionnaire (FIQ) was applied at pre- and postintervention moments and in five visits over eight weeks.
RESULTS
There were no significant differences on baseline FIQ score between groups. However, after the intervention, the cannabis group presented a significant decrease in FIQ score in comparison with the placebo group (P = 0.005) and in comparison with cannabis group baseline score. (P < 0.001). Analyzing isolated items on the FIQ, the cannabis group presented significant improvement on the ""feel good,"" ""pain,"" ""do work,"" and ""fatigue"" scores. The placebo group presented significant improvement on the ""depression"" score after intervention. There were no intolerable adverse effects.
CONCLUSIONS
Phytocannabinoids can be a low-cost and well-tolerated therapy to reduce symptoms and increase the quality of life of patients with fibromyalgia. Future studies are still needed to assess long-term benefits, and studies with different varieties of cannabinoids associated with a washout period must be done to enhance our knowledge of cannabis action in this health condition.",2020,"However, after the intervention, the cannabis group presented a significant decrease in FIQ score in comparison with the placebo group (P = 0.005) and in comparison with cannabis group baseline score.","['People with Fibromyalgia', 'fibromyalgia patients', '17 women with fibromyalgia, residents of a neighborhood with a low socioeconomic profile and a high incidence of violence in the city of Florianopolis, Brazil', 'patients with fibromyalgia']","['tetrahydrocannabinol (THC)-rich cannabis oil', 'cannabidiol [CBD', 'placebo', 'THC-rich cannabis oil (24.44\u2009mg/mL of THC', 'Placebo', 'THC-Rich Cannabis Oil']","['feel good,"" ""pain,"" ""do work,"" and ""fatigue"" scores', 'Fibromyalgia Impact Questionnaire (FIQ', 'baseline FIQ score', 'FIQ score', 'depression"" score', 'intolerable adverse effects', 'symptoms and quality of life', 'quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0556617', 'cui_str': 'Cannabis oil'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439294', 'cui_str': 'g/L'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",17.0,0.529243,"However, after the intervention, the cannabis group presented a significant decrease in FIQ score in comparison with the placebo group (P = 0.005) and in comparison with cannabis group baseline score.","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Chaves', 'Affiliation': 'Public Health School, Municipal Health Secretary, Florianopolis, Brazil.'}, {'ForeName': 'Paulo Cesar T', 'Initials': 'PCT', 'LastName': 'Bittencourt', 'Affiliation': 'Department of Internal Medicine, Federal University of Santa Catarina, Florianopolis, Brazil.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Pelegrini', 'Affiliation': 'Department of Physical Education, Santa Catarina State University, Florianopolis, Brazil.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa303']
1462,33113452,Using Machine Learning to Predict Suicide Attempts in Military Personnel.,"Identifying predictors of suicide attempts is critical in intervention and prevention efforts, yet finding predictors has proven difficult due to the low base rate and underpowered statistical approaches. The objective of the current study was to use machine learning to examine predictors of suicidal behaviors among high-risk suicidal Soldiers who received outpatient mental health services in a randomized controlled trial of Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT) compared to treatment as usual (TAU). Self-report measures of clinical and demographic variables, administered prior to the start of outpatient treatment to 152 participants with recent suicidal thoughts and/or behaviors were analyzed using machine learning software to identify the best combination of variables for predicting suicide attempts during or after treatment. Worst-point suicidal ideation, history of multiple suicide attempts, treatment group (i.e., BCBT or TAU), suicidogenic cognitions, and male sex were found, in combination, correctly classified 30.8% of patients who attempted suicide during the two-year follow-up period. This combination has higher sensitivity than many models that have previously been used to predict suicidal behavior. Overall, this study provides a combination of variables that can be assessed clinical to help identify high-risk suicidal individuals.",2020,"Worst-point suicidal ideation, history of multiple suicide attempts, treatment group (i.e., BCBT or TAU), suicidogenic cognitions, and male sex were found, in combination, correctly classified 30.8% of patients who attempted suicide during the two-year follow-up period.","['high-risk suicidal Soldiers who received outpatient mental health services', '152 participants with recent suicidal thoughts and/or behaviors', 'Military Personnel']","['Machine Learning', 'machine learning', 'Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT']",['suicidal behaviors'],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention'}]","[{'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}]",152.0,0.0395007,"Worst-point suicidal ideation, history of multiple suicide attempts, treatment group (i.e., BCBT or TAU), suicidogenic cognitions, and male sex were found, in combination, correctly classified 30.8% of patients who attempted suicide during the two-year follow-up period.","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Rozek', 'Affiliation': 'UCF RESTORES and Department of Psychology, University of Central Florida. Electronic address: david.rozek@ucf.edu.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Andres', 'Affiliation': 'Boston College, Boston, MA.'}, {'ForeName': 'Noelle B', 'Initials': 'NB', 'LastName': 'Smith', 'Affiliation': 'VA Northeast Program Evaluation Center, West Haven, CT, USA; Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Feea R', 'Initials': 'FR', 'LastName': 'Leifker', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Arne', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Jennings', 'Affiliation': 'Varen Technologies.'}, {'ForeName': 'Nate', 'Initials': 'N', 'LastName': 'Dartnell', 'Affiliation': 'MondoBrain.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'The Ohio State University Wexner Medical Center.'}, {'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Rudd', 'Affiliation': 'University of Memphis, Memphis, TN, USA.'}]",Psychiatry research,['10.1016/j.psychres.2020.113515']
1463,33113486,Integrating yoga with psychological group-treatment for mixed depression and anxiety in primary healthcare: An explorative pilot study.,"BACKGROUND AND PURPOSE
Yoga has shown promise as a treatment for depression and anxiety. The present pilot study investigated the feasibility of an eight-week grouptreatment integrating emotion-focused psychoeducation, compassion-focused therapy, and Virya yoga for depression and anxiety in primary healthcare.
MATERIALS AND METHODS
Patients seeking treatment for depression and anxiety in a primary healthcare centre completed either an integrative group-treatment (N = 14) or treatment as usual (TAU, N = 17). Outcome measures were analysed pre- and posttreatment. Correlations in the intervention group were investigated between treatment outcomes and amount of yoga practice between sessions.
RESULTS
Large within-group effect sizes on all outcome measures were found at posttreatment. Symptom reduction did not differ between groups (p = 0.155). Improvement in alexithymia correlated significantly (p < 0.05) with amount of yoga practice between sessions.
CONCLUSION
Integrating yoga with a psychological group-treatment is a somewhat feasible approach to treatment for depression and anxiety in primary healthcare.",2020,"Improvement in alexithymia correlated significantly (p < 0.05) with amount of yoga practice between sessions.
","['Patients seeking treatment for depression and anxiety in a primary healthcare centre completed either an', 'primary healthcare']","['integrative group-treatment (N\xa0=\xa014) or treatment as usual (TAU', 'eight-week grouptreatment integrating emotion-focused psychoeducation, compassion-focused therapy, and Virya yoga', 'Integrating yoga with psychological group-treatment']","['alexithymia', 'Symptom reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0320634,"Improvement in alexithymia correlated significantly (p < 0.05) with amount of yoga practice between sessions.
","[{'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Jonsson', 'Affiliation': 'Department of Psychology, Umeå University, 901 87, Umeå, Sweden. Electronic address: gustav@psykologiochutveckling.se.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Franzén', 'Affiliation': 'Department of Psychology, Umeå University, 901 87, Umeå, Sweden. Electronic address: lisa.franzen@regionvarmland.se.'}, {'ForeName': 'Markus B T', 'Initials': 'MBT', 'LastName': 'Nyström', 'Affiliation': 'Department of Psychology, Umeå University, 901 87, Umeå, Sweden. Electronic address: Markus.nystrom@umu.se.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Davis', 'Affiliation': 'Department of Psychology, Umeå University, 901 87, Umeå, Sweden. Electronic address: Paul.davis@umu.se.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101250']
1464,33115760,Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme.,"OBJECTIVES
This integrated analysis presents the safety profile of upadacitinib, a Janus kinase inhibitor, at 15 mg and 30 mg once daily in patients with moderately to severely active rheumatoid arthritis (RA).
METHODS
Treatment-emergent adverse events (TEAEs) and laboratory data from five randomised, placebo- or active-controlled phase III trials of upadacitinib for patients with RA were analysed and summarised. Exposure-adjusted event rates are shown for placebo (three trials; 12/14 weeks), methotrexate (two trials; mean exposure: 36 weeks), adalimumab (one trial; mean exposure: 42 weeks), upadacitinib 15 mg (five trials; mean exposure: 53 weeks) and upadacitinib 30 mg (four trials; mean exposure: 59 weeks).
RESULTS
3834 patients received one or more doses of upadacitinib 15 mg (n=2630) or 30 mg (n=1204), for a total of 4020.1 patient-years of exposure. Upper respiratory tract infection, nasopharyngitis and urinary tract infection were the most commonly reported TEAEs with upadacitinib. Rates of serious infection were similar between upadacitinib 15 mg and adalimumab but higher compared with methotrexate. Rates of herpes zoster and creatine phosphokinase (CPK) elevations were higher in both upadacitinib groups versus methotrexate and adalimumab, and rates of gastrointestinal perforations were higher with upadacitinib 30 mg. Rates of deaths, malignancies, adjudicated major adverse cardiovascular events (MACEs) and venous thromboembolic events (VTEs) were similar across treatment groups.
CONCLUSION
In the phase III clinical programme for RA, patients receiving upadacitinib had an increased risk of herpes zoster and CPK elevation versus adalimumab. Rates of malignancies, MACEs and VTEs were similar among patients receiving upadacitinib, methotrexate or adalimumab.
TRIAL REGISTRATION NUMBERS
SELECT-EARLY: NCT02706873; SELECT-NEXT: NCT02675426; SELECT-COMPARE: NCT02629159; SELECT-MONOTHERAPY: NCT02706951; SELECT-BEYOND: NCT02706847.",2020,"Rates of herpes zoster and creatine phosphokinase (CPK) elevations were higher in both upadacitinib groups versus methotrexate and adalimumab, and rates of gastrointestinal perforations were higher with upadacitinib 30 mg.","['rheumatoid arthritis', '3834 patients', 'patients with moderately to severely active rheumatoid arthritis (RA']","['methotrexate and adalimumab', 'methotrexate', 'methotrexate or adalimumab', 'upadacitinib', 'placebo', 'adalimumab']","['rates of gastrointestinal perforations', 'risk of herpes zoster and CPK elevation', 'Rates of malignancies, MACEs and VTEs', 'Rates of serious infection', 'Upper respiratory tract infection, nasopharyngitis and urinary tract infection', 'Rates of deaths, malignancies, adjudicated major adverse cardiovascular events (MACEs) and venous thromboembolic events (VTEs', 'Rates of herpes zoster and creatine phosphokinase (CPK) elevations']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0151664', 'cui_str': 'Gastrointestinal perforation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",3834.0,0.236005,"Rates of herpes zoster and creatine phosphokinase (CPK) elevations were higher in both upadacitinib groups versus methotrexate and adalimumab, and rates of gastrointestinal perforations were higher with upadacitinib 30 mg.","[{'ForeName': 'Stanley B', 'Initials': 'SB', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, Dallas, Texas, USA arthdoc@aol.com.'}, {'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'van Vollenhoven', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Winthrop', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Cristiano A F', 'Initials': 'CAF', 'LastName': 'Zerbini', 'Affiliation': 'Centro Universitario Central Paulista, São Paulo, Brazil.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'University of Occupational and Environmental Health Japan, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bessette', 'Affiliation': 'Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Khan', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hendrickson', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Jeffrey V', 'Initials': 'JV', 'LastName': 'Enejosa', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Gerd R', 'Initials': 'GR', 'LastName': 'Burmester', 'Affiliation': 'Charité Universitätsmedizin Berlin, Berlin, Germany.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-218510']
1465,33118053,Correction to: Assessing sleep-wake survival dynamics in relation to sleep quality in a placebo-controlled pharmacological intervention study with people with insomnia and healthy controls.,"In the first column of table 2, it says: 'REM Weibull scale, 1/ʎ'. NREM Weibull scale 1/ʎ, and Wake Weibull scale 1/ʎ.",2020,"In the first column of table 2, it says: 'REM Weibull scale, 1/ʎ'.",['people with insomnia and healthy controls'],['placebo-controlled pharmacological intervention'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0141234,"In the first column of table 2, it says: 'REM Weibull scale, 1/ʎ'.","[{'ForeName': 'Lieke W A', 'Initials': 'LWA', 'LastName': 'Hermans', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands. l.w.a.hermans@tue.nl.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Regis', 'Affiliation': 'Department of Mathematics and Computer Science, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Fonseca', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Overeem', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Tim R M', 'Initials': 'TRM', 'LastName': 'Leufkens', 'Affiliation': 'Philips Research, High Tech Campus 34, Eindhoven, The Netherlands.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Vermeeren', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, Maastricht, The Netherlands.'}, {'ForeName': 'Merel M', 'Initials': 'MM', 'LastName': 'van Gilst', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}]",Psychopharmacology,['10.1007/s00213-020-05675-w']
1466,32991872,Inaccurate Use of the Upper Extremity Fugl-Meyer Negatively Affects Upper Extremity Rehabilitation Trial Design: Findings From the ICARE Randomized Controlled Trial.,"OBJECTIVE
To determine the extent to which estimates of sample and effect size in stroke rehabilitation trials can be affected by simple summation of ordinal Upper Extremity Fugl-Meyer (UEFM) items compared with a Rasch-rescaled UEFM.
DESIGN
Rasch analysis of Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) phase III trial data, comparing 3 upper extremity (UE) motor treatments in stroke survivors enrolled 45.8±22.4 days poststroke. Participants underwent a structured UE motor training known as the Accelerated Skill Acquisition Program, usual and customary care, or dose-equivalent care. UEFM data from baseline, postintervention, and 6 and 12 months later were included for analysis.
SETTING
Outpatient stroke rehabilitation.
PARTICIPANTS
ICARE participants (N=361).
INTERVENTIONS
Not applicable.
MAIN OUTCOME MEASURES
Item difficulties, person abilities, and sample size.
RESULTS
Because of their ordinality, summed raw UEFM scores measured motor impairment inconsistently across different ranges of stroke severity relative to the rescaled UEFM. In the full ICARE sample, raw UEFM understated scores relative to the rescaled UEFM by 7.4 points for the most severely impaired, but overstated scores by up to 8.4 points toward the ceiling. As a result, 50.9% of all UEFM observations showed a residual error greater than 10% of the total UEFM score. Relative to the raw scores, the rescaled UEFM improved the effect size of change in motor impairment between baseline and 1 year (d=0.35). For a hypothetical 3-arm trial resembling ICARE, UEFM rescaling reduced the required sample size by 32% (n=108) compared with raw UEFM (n=159).
CONCLUSIONS
In UE rehabilitation trials, a rescaled UEFM potentially decreases sample size by one-third, decreasing costs, duration, and the number of subjects exposed to experimental risks. This benefit is obtained through increased measurement efficiency. Reductions in ceiling effects are also possible. These findings apply to ICARE-like trials. Confirmatory validation in another phase III trial is needed.",2020,"For a hypothetical 3-arm trial resembling ICARE, UEFM rescaling reduced the required sample size by 32% (n=108) compared with raw UEFM (n=159).
","['Outpatient stroke rehabilitation', 'ICARE participants (N=361', 'stroke survivors enrolled 45.8±22.4 days poststroke']","['raw UEFM', 'structured UE motor training known as the Accelerated Skill Acquisition Program, usual and customary care, or dose-equivalent care']","['Item difficulties, person abilities, and sample size']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0431070', 'cui_str': 'Assessment for rehabilitation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]","[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}]",,0.251887,"For a hypothetical 3-arm trial resembling ICARE, UEFM rescaling reduced the required sample size by 32% (n=108) compared with raw UEFM (n=159).
","[{'ForeName': 'Shashwati', 'Initials': 'S', 'LastName': 'Geed', 'Affiliation': 'Department of Rehabilitation Medicine, Center for Brain Plasticity and Recovery, Georgetown University and MedStar National Rehabilitation Hospital, Washington, DC. Electronic address: sg1075@georgetown.edu.'}, {'ForeName': 'Christianne J', 'Initials': 'CJ', 'LastName': 'Lane', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Monica A', 'Initials': 'MA', 'LastName': 'Nelsen', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Wolf', 'Affiliation': 'Department of Rehabilitation Medicine, Division of Physical Therapy, Emory School of Medicine, Atlanta, GA; Department of Medicine, Emory School of Medicine, Atlanta, GA; Department of Cell Biology, Emory School of Medicine, Atlanta, GA; Center for Visual and Neurocognitive Rehabilitation, Atlanta VA Health Services, Decatur, GA.'}, {'ForeName': 'Carolee J', 'Initials': 'CJ', 'LastName': 'Winstein', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, Herman Ostrow School of Dentistry, Keck School of Medicine, University of Southern California, Los Angeles, CA; Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Alexander W', 'Initials': 'AW', 'LastName': 'Dromerick', 'Affiliation': 'Department of Rehabilitation Medicine, Center for Brain Plasticity and Recovery, Georgetown University and MedStar National Rehabilitation Hospital, Washington, DC; Department of Neurology, Center for Brain Plasticity and Recovery, Georgetown University and MedStar National Rehabilitation Hospital, Washington, DC.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.08.019']
1467,33131222,A Continuous Quality Improvement Intervention to Improve Antenatal HIV Care Testing in Rural South Africa: Evaluation of Implementation in a Real-World Setting.,"BACKGROUND
We evaluated continuous quality improvement (CQI) targeting antenatal HIV care quality in rural South Africa using a stepped-wedge cluster-randomised controlled trial (Management and Optimisation of Nutrition, Antenatal, Reproductive, Child health, MONARCH) and an embedded process evaluation. Here, we present results of the process evaluation examining determinants of CQI practice and 'normalisation.'
METHODS
A team of CQI mentors supported public-sector health workers in seven primary care clinics to (1) identify root causes of poor HIV viral load (VL) monitoring among pregnant women living with HIV and repeat HIV testing among pregnant women not living with HIV, and (2) design and iteratively test their own solutions. We used a mixed methods evaluation with field notes from CQI mentors ('dose' and 'reach' of CQI, causes of poor HIV care testing rates, implemented change ideas); patient medical records (HIV care testing by clinic and time step); and semi-structured interviews with available health workers. We analysed field notes andsemi-structured interviews for determinants of CQI implementation and 'normalisation' using Normalisation Process Theory (NPT) and Tailored Implementation of Chronic Diseases (TICD) frameworks.
RESULTS
All interviewed health workers found the CQI mentors and methodology helpful for quality improvement. Total administered 'dose' was higher than planned but 'reach' was limited by resource constraints, particularly staffing shortages. Simple workable improvements to identified root causes were implemented, such as a patient tracking notebook and results filing system. VL monitoring improved over time, but not repeat HIV testing. Besides resource constraints, gaps in knowledge of guidelines, lack of leadership, poor clinical documentation, and data quality gaps reduced CQI implementation fidelity and normalisation.
CONCLUSION
While CQI holds promise, we identified several health system challenges. Priorities for policy makers include improving staffing and strategies to improve clinical documentation. Additional support with implementing clinical guidelines and improving routine data quality are needed. Normalising CQI may be challenging without concurrent health system improvements.",2020,"Simple workable improvements to identified root causes were implemented, such as a patient tracking notebook and results filing system.","['Rural South Africa', 'patient medical records (HIV care testing by clinic and time step); and semi-structured interviews with available health workers', 'A team of CQI mentors supported public-sector health workers in seven primary care clinics to (1) identify root causes of poor HIV viral load (VL) monitoring among pregnant women living with HIV and repeat HIV testing among pregnant women not living with HIV, and (2) design and iteratively test their own solutions', 'rural South Africa']","['continuous quality improvement (CQI', ""CQI implementation and 'normalisation' using Normalisation Process Theory (NPT""]",[],"[{'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",[],,0.0412597,"Simple workable improvements to identified root causes were implemented, such as a patient tracking notebook and results filing system.","[{'ForeName': 'H Manisha', 'Initials': 'HM', 'LastName': 'Yapa', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Dhlomo-Mphatswe', 'Affiliation': 'School of Clinical Medicine, Discipline of Obstetrics and Gynaecology, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Mosa', 'Initials': 'M', 'LastName': 'Moshabela', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Jan-Walter', 'Initials': 'JW', 'LastName': 'De Neve', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Faculty of Medicine and University Hospital, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Herbst', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Awachana', 'Initials': 'A', 'LastName': 'Jiamsakul', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Petoumenos', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Post', 'Affiliation': ""King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Deenan', 'Initials': 'D', 'LastName': 'Pillay', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}]",International journal of health policy and management,['10.34172/ijhpm.2020.178']
1468,33131248,Early progression of disease predicts shorter survival in MALT lymphoma patients receiving systemic treatment.,"Early progression of disease (POD) within two years from diagnosis is linked with poor overall survival (OS) in follicular lymphoma but its prognostic role is less clear in extranodal marginal zone B-cell lymphoma (EMZL). We sought to identify prognostic factors associated with early POD and to determine whether is associated with inferior OS. We analyzed the impact of early POD in the IELSG19 clinical trial dataset (training set of 401 patients randomly assigned to chlorambucil or rituximab or chlorambucil plus rituximab). Reproducibility was examined in a validation set of 287 patients who received systemic treatment. In both sets, we excluded from the analysis the patients who, within 24 months from treatment start, died without progression or were lost to follow-up without prior progression. OS was calculated from progression in patients with early POD and from 24 months after start of treatment in those without (reference group). Early POD was observed in 69 of the 384 (18%) evaluable patients of the IELSG19 study. Patients with high-risk MALT-IPI were more likely to have early POD (p=0.006). The 10-year OS rate was 64% in the early POD group and 85% in the reference group (HR= 2.42, 95%CI, 1.35-4.34; log-rank P=0.002). This prognostic impact was confirmed in the validation set, in which early POD was observed in 64 out of 224 (29%) evaluable patients with 10-year OS rate of 48% in the early POD group and 71% in the reference group (HR= 2.15, 95%CI, 1.19-3.90; log-rank P=0.009). In patients with EMZL who received front-line systemic treatment, early POD is associated with poorer survival and may represent a useful endpoint in future prospective clinical trials.",2020,Patients with high-risk MALT-IPI were more likely to have early POD (p=0.006).,"['287 patients who received systemic treatment', 'Patients with high-risk MALT-IPI', '401 patients randomly assigned to', 'MALT lymphoma patients receiving systemic treatment']",['chlorambucil or rituximab or chlorambucil plus rituximab'],"['Early POD', 'Early progression of disease (POD', 'Reproducibility', '10-year OS rate']","[{'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0024651', 'cui_str': 'Malt'}, {'cui': 'C0668760', 'cui_str': 'diinosine pentaphosphate'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0242647', 'cui_str': 'Mucosa-associated lymphoma'}]","[{'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",401.0,0.0634302,Patients with high-risk MALT-IPI were more likely to have early POD (p=0.006).,"[{'ForeName': '', 'Initials': '', 'LastName': 'Annarita Conconi', 'Affiliation': 'Division of Hematology, Ospedale degli Infermi, Biella, Italy;.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Catherine Thieblemont', 'Affiliation': 'Hemato-Oncology Department, Saint Louis Hospital, Paris, France;.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Luciano Cascione', 'Affiliation': 'Institute of Oncology Research, Bellinzona, Switzerland;.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Valter Torri', 'Affiliation': 'Clinical Research Methodology Laboratory, IRCCS Mario Negri Institute, Milan, Italy;.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Barbara Kiesewetter', 'Affiliation': 'Division of Oncology, Department of Internal Medicine I, Medical University of Vienna,Vienna,Austria;.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Gloria Margiotta Casaluci', 'Affiliation': 'Division of Hematology, Dept. of Translational Medicine, University of Eastern Piedmont,Novara,Italy;.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Gianluca Gaidano', 'Affiliation': 'Division of Hematology, Dept. of Translational Medicine, University of Eastern Piedmont,Novara,Italy;.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Markus Raderer', 'Affiliation': 'Division of Oncology, Department of Internal Medicine I, Medical University of Vienna,Vienna,Austria;.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Franco Cavalli', 'Affiliation': 'Institute of Oncology Research, Bellinzona, Switzerland;.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Armando Lopez Guillermo', 'Affiliation': 'Department of Hematology, Hospital Clinic, Barcelona, Spain;.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Peter W Johnson', 'Affiliation': 'Cancer Research UK Center, Southampton General Hospital, Southampton, United Kingdom;.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Emanuele Zucca', 'Affiliation': 'Division of Medical Oncology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}]",Haematologica,['10.3324/haematol.2019.237990']
1469,33131314,Factors Associated With Failure to Achieve the Intensive Blood Pressure Target in the Systolic Blood Pressure Intervention Trial (SPRINT).,"SPRINT (Systolic Blood Pressure Intervention Trial) found that randomization of nondiabetic participants at high cardiovascular risk to an intensive (systolic blood pressure [SBP] <120 mm Hg) versus standard (SBP <140 mm Hg) target resulted in 25% risk reduction in the first cardiovascular composite event (ie, cardiovascular death or nonfatal myocardial infarction, stroke, or hospitalization for heart failure) and a 27% risk reduction in all-cause mortality. In this post hoc analysis, we sought to determine the factors associated with failure to achieve the SBP target in 4678 SPRINT participants randomized to the intensive treatment group. Using a generalized estimating equation model, we assessed variables associated with failure to achieve the intensive SBP target as a repeated outcome collected during serial follow-up visits, including the occurrence of serious adverse events. In the multivariable model adjusted for baseline demographic, clinical, and laboratory variables, older age, higher SBP, underlying chronic kidney disease, higher number of antihypertensives, and moderate cognitive impairment at screening were associated with failure to achieve the intensive SBP target. Occurrence of a serious adverse event during the trial was associated with 20% higher odds of failure to achieve the SBP target. Participants of Hispanic ethnicity had 47% lower odds of failure to achieve the intensive SBP target relative to non-Hispanic Whites. Understanding barriers to achieving intensive SBP targets should allow clinicians to optimize management of hypertension in patients at high risk for cardiovascular disease.",2020,Participants of Hispanic ethnicity had 47% lower odds of failure to achieve the intensive SBP target relative to non-Hispanic Whites.,"['nondiabetic participants at high cardiovascular risk to an intensive (systolic blood pressure [SBP] <120 mm Hg', 'patients at high risk for cardiovascular disease']",[],"['cardiovascular composite event (ie, cardiovascular death or nonfatal myocardial infarction, stroke, or hospitalization for heart failure']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",[],"[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",4678.0,0.0459267,Participants of Hispanic ethnicity had 47% lower odds of failure to achieve the intensive SBP target relative to non-Hispanic Whites.,"[{'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Wang', 'Affiliation': 'From the Division of Nephrology, Department of Medicine, Stanford University, Palo Alto, CA.'}, {'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Stedman', 'Affiliation': 'From the Division of Nephrology, Department of Medicine, Stanford University, Palo Alto, CA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'From the Division of Nephrology, Department of Medicine, Stanford University, Palo Alto, CA.'}, {'ForeName': 'Tara I', 'Initials': 'TI', 'LastName': 'Chang', 'Affiliation': 'From the Division of Nephrology, Department of Medicine, Stanford University, Palo Alto, CA.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.16155']
1470,33131908,Dose-dependent reductions in plasma ceramides after anthocyanin supplementation are associated with improvements in plasma lipids and cholesterol efflux capacity in dyslipidemia: A randomized controlled trial.,"BACKGROUND & AIMS
Plasma ceramides have been identified as novel risk factors for metabolic and cardiovascular diseases. We aimed to evaluate the effects of dietary anthocyanins on plasma ceramides and to disentangle whether the alterations in ceramides could be related with those in other cardiometabolic risk factors in the dyslipidemia.
METHODS
In a randomized double-blinded placebo-controlled trial, 176 eligible dyslipidemia subjects were randomly assigned into four groups receiving placebo, 40, 80, or 320 mg/day anthocyanins, respectively for 12 weeks.
RESULTS
A total of 169 subjects completed the study. After 12-week intervention, dietary anthocyanins dose-dependently reduced plasma concentrations of all six ceramide species in the dyslipidemia subjects (all P trend values < 0.05). Specifically, 320 mg/day anthocyanins effectively lowered plasma N-palmitoylsphingosine (Cer 16:0, mean change: -28.3 ± 41.2 versus 2.9 ± 38.2, nmol/L, P = 0.018) and N-tetracosanoylsphingosine (Cer 24:0, mean change: -157.1 ± 493.9 versus 10.7 ± 439.9, nmol/L, P = 0.002) compared with the placebo. The declines in plasma Cer 16:0 and Cer 24:0 were significantly correlated with the decreases in plasma non-high-density lipoprotein cholesterol (nonHDL-C, Spearman's r = 0.32, P = 0.040 for Cer 16:0; Spearman's r = 0.35, P = 0.026 for Cer 24:0), apolipoprotein B (Spearman's r = 0.33, P = 0.031 for Cer 16:0; Spearman's r = 0.48, P = 0.002 for Cer 24:0), and total cholesterol (Spearman's r = 0.34, P = 0.026 for Cer 16:0; Spearman's r = 0.31, P = 0.042 for Cer 24:0) after 12-week 320 mg/day anthocyanin administration. Besides, we found that anthocyanins at 320 mg/day also markedly enhanced cholesterol efflux capacity in the dyslipidemia, the changes of which were positively associated with the reductions in Cer 16:0 (Spearman's r = 0.42, P = 0.006) independent of HDL-C and apolipoprotein A-I.
CONCLUSIONS
Reductions in plasma Cer 16:0 and Cer 18:0 after 12-week anthocyanin intervention were dose-dependently associated with improvements in plasma lipids and cholesterol efflux capacity in the dyslipidemia.
CLINICAL TRIAL REGISTRATION
The study was registered at ClinicalTrials.gov with the identifier No. NCT03415503.",2020,"After 12-week intervention, dietary anthocyanins dose-dependently reduced plasma concentrations of all six ceramide species in the dyslipidemia subjects (all P trend values < 0.05).","['169 subjects completed the study', '176 eligible dyslipidemia subjects']","['anthocyanins', 'anthocyanin supplementation', 'placebo', 'dietary anthocyanins']","['plasma lipids and cholesterol efflux capacity', 'total cholesterol', 'plasma concentrations', 'plasma non-high-density lipoprotein cholesterol', 'plasma lipids and cholesterol efflux capacity in dyslipidemia', 'plasma N-palmitoylsphingosine', 'apolipoprotein B', 'cholesterol efflux capacity', 'plasma Cer']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0386062', 'cui_str': 'N-palmitoylsphingosine'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0237504', 'cui_str': 'CER'}]",176.0,0.200688,"After 12-week intervention, dietary anthocyanins dose-dependently reduced plasma concentrations of all six ceramide species in the dyslipidemia subjects (all P trend values < 0.05).","[{'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zezhong', 'Initials': 'Z', 'LastName': 'Tian', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Kongyao', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Die', 'Initials': 'D', 'LastName': 'Fan', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xilin', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Provincial Key Laboratory of Food, Nutrition, and Health, Sun Yat-sen University, Guangzhou, Guangdong, China; Guangdong Engineering Technology Center of Nutrition Transformation, Sun Yat-sen University, Guangzhou, Guangdong, China. Electronic address: yangyan3@mail.sysu.edu.cn.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.014']
1471,33131909,The effect of a duodenal-jejunal bypass liner on lipid profile and blood concentrations of long chain polyunsaturated fatty acids.,"BACKGROUND & AIMS
Duodenal-jejunal bypass liners (DJBLs) prevent absorption in the proximal small intestine, the site of fatty acid absorption. We sought to investigate the effects of a DJBL on blood concentrations of essential fatty acids (EFAs) and bioactive polyunsaturated fatty acids (PUFAs).
METHODS
Sub-study of a multicentre, randomised, controlled trial with two treatment groups. Patients aged 18-65 years with type-2 diabetes mellitus and body mass index 30-50 kg/m 2 were randomised to receive a DJBL for 12 months or best medical therapy, diet and exercise. Whole plasma PUFA concentrations were determined at baseline, 10 days, 6 and 11.5 months; data were available for n = 70 patients per group.
RESULTS
Weight loss was significantly greater in the DJBL group compared to controls after 11.5 months: total body weight loss 11.3 ± 5.3% versus 6.0 ± 5.7% (mean difference [95% CI] = 5.27% [3.75, 6.80], p < 0.001). Absolute concentrations of both EFAs, linoleic acid and α-linolenic acid, and their bioactive derivatives, arachidonic acid, eicosapentaenoic acid, docosapentaenoic acid and docosahexaenoic acid, were significantly lower in the DJBL group than in the control group at 6 and 11.5 months follow-up. Total serum cholesterol, LDL-cholesterol and HDL-cholesterol were also significantly lower in the DJBL group.
CONCLUSION
One year of DJBL therapy is associated with superior weight loss and greater reductions in total serum cholesterol and LDL-cholesterol, but also depletion of EFAs and their longer chain derivatives. DJBL therapy may need to be offset by maintaining an adequate dietary intake of PUFAs or by supplementation.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier NCT02459561.",2020,"One year of DJBL therapy is associated with superior weight loss and greater reductions in total serum cholesterol and LDL-cholesterol, but also depletion of EFAs and their longer chain derivatives.","['70 patients per group', 'Patients aged 18-65 years with type-2 diabetes mellitus and body mass index 30-50\xa0kg/m 2']","['DJBL', 'DJBL for 12 months or best medical therapy, diet and exercise', 'Duodenal-jejunal bypass liners (DJBLs', 'duodenal-jejunal bypass liner']","['total serum cholesterol and LDL-cholesterol', 'total body weight loss', 'Total serum cholesterol, LDL-cholesterol and HDL-cholesterol', 'Whole plasma PUFA concentrations', 'superior weight loss', 'blood concentrations of essential fatty acids (EFAs) and bioactive polyunsaturated fatty acids (PUFAs', 'Absolute concentrations of both EFAs, linoleic acid and α-linolenic acid, and their bioactive derivatives, arachidonic acid, eicosapentaenoic acid, docosapentaenoic acid and docosahexaenoic acid', 'Weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3880361', 'cui_str': 'Duodenal-jejunal bypass liner'}]","[{'cui': 'C1445957', 'cui_str': 'Serum total cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0015686', 'cui_str': 'Fatty Acids, Essential'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]",,0.104392,"One year of DJBL therapy is associated with superior weight loss and greater reductions in total serum cholesterol and LDL-cholesterol, but also depletion of EFAs and their longer chain derivatives.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Glaysher', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK. Electronic address: michaelglaysher@me.com.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ward', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Madhawi', 'Initials': 'M', 'LastName': 'Aldhwayan', 'Affiliation': 'Imperial College London, London, UK; Department of Community Health Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Aruchuna', 'Initials': 'A', 'LastName': 'Ruban', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Christina Gabriele', 'Initials': 'CG', 'LastName': 'Prechtl', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Helena L', 'Initials': 'HL', 'LastName': 'Fisk', 'Affiliation': 'School of Human Development & Health, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Navpreet', 'Initials': 'N', 'LastName': 'Chhina', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Werd', 'Initials': 'W', 'LastName': 'Al-Najim', 'Affiliation': 'Imperial College London, London, UK; Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Klimowska-Nassar', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Johnson', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Emmanuela', 'Initials': 'E', 'LastName': 'Falaschetti', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Goldstone', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Alexander Dimitri', 'Initials': 'AD', 'LastName': 'Miras', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Byrne', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'School of Human Development & Health, Faculty of Medicine, University of Southampton, Southampton, UK; NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UK.'}, {'ForeName': 'Julian P', 'Initials': 'JP', 'LastName': 'Teare', 'Affiliation': 'Imperial College London, London, UK.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.026']
1472,33131927,Testing a best practices risk result format to communicate genetic risks.,"OBJECTIVE
To investigate the effect of a genetic report format using risk communication ""best-practices"" on risk perceptions, in part to reduce risk overestimates.
METHODS
Adults (N = 470) from the Coriell Personalized Medicine Collaborative (CPMC) were randomized to a 2 × 2 experimental design to receive a hypothetical ""personalized"" genetic risk result for leukemia (relative risk = 1.5 or 2.5) through either the standard CPMC report (N = 232) or an enriched report informed by best practices (N = 238). A one-time, online survey assessed numeracy and risk perceptions including ""feelings of risk"" and a numerical estimate.
RESULTS
Regardless of numeracy, participants who received the enriched report had fewer overestimates of their lifetime risk estimate (LRE; odds ratio = 0.19, p < .001) and lower feelings of risk on two of three measures (p < .001). Participants with higher numeracy scores had fewer overestimates of LRE (OR = 0.66, p < .001) and lower feelings of risk on two out of three measures (p ≤ .01); the interaction between numeracy and report format was non-significant.
CONCLUSION
The enriched report produced more accurate LRE and lower risk perceptions regardless of numeracy level, suggesting the enriched format was helpful to individuals irrespective of numeracy ability.
PRACTICE IMPLICATIONS
Best practice elements in risk reports may help individuals form more accurate risk perceptions.",2020,"Participants with higher numeracy scores had fewer overestimates of LRE (OR = 0.66, p < .001) and lower feelings of risk on two out of three measures (p ≤ .01); the interaction between numeracy and report format was non-significant.
CONCLUSION
",['Adults (N\u202f=\u202f470) from the Coriell Personalized Medicine Collaborative (CPMC'],"['genetic report format using risk communication ""best-practices', 'hypothetical ""personalized"" genetic risk result for leukemia (relative risk = 1.5 or 2.5) through either the standard CPMC report (N = 232) or an enriched report informed by best practices']","['overestimates of their lifetime risk estimate', 'LRE', 'feelings of risk"" and a numerical estimate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0700287', 'cui_str': 'Informing'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.0545622,"Participants with higher numeracy scores had fewer overestimates of LRE (OR = 0.66, p < .001) and lower feelings of risk on two out of three measures (p ≤ .01); the interaction between numeracy and report format was non-significant.
CONCLUSION
","[{'ForeName': 'Kyle W', 'Initials': 'KW', 'LastName': 'Davis', 'Affiliation': 'Lineagen, Inc., Salt Lake City, UT, USA; Social and Behavioral Research Branch, National Human Genome Research Institute, NIH, Bethesda, USA. Electronic address: kyle.walter.davis@gmail.com.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Roter', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Schmidlen', 'Affiliation': 'Geisinger, Genomic Medicine Institute, Danville, USA; Coriell Institute for Medical Research, Camden, USA.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Scheinfeldt', 'Affiliation': 'Coriell Institute for Medical Research, Camden, USA.'}, {'ForeName': 'William M P', 'Initials': 'WMP', 'LastName': 'Klein', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, NIH, Bethesda, USA; Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, USA; Behavioral Research Program, National Cancer Institute, NIH, Bethesda, USA.'}]",Patient education and counseling,['10.1016/j.pec.2020.10.021']
1473,33131932,The respiratory syncytial virus fusion protein-specific B cell receptor repertoire reshaped by post-fusion subunit vaccination.,"Respiratory syncytial virus (RSV) is the major cause of acute lower respiratory illness in children of less than 5 years of age which usually results in hospitalization or even in death. Vaccine development is hampered in consequence of a failed vaccine trial with fatalities in the 1960s. Even though research has been more focused on the RSV fusion protein in its pre-fusion conformation, maternal vaccination with post-fusion protein (post F) was considered as a promising vaccine strategy for passive immunization of babies, because post F preserves very potent neutralizing epitopes. We extensively analyzed post F-binding B cell receptor (BCR) repertoires of three vaccinees who received a post F-subunit vaccine in the context of a first-in-human, Phase 1, randomized, observer-blind, placebo-controlled clinical trial (ClinicalTrials.gov Identifier: NCT02298179). In order to compare the vaccine-induced BCR repertoires with BCR repertoires induced by natural infection, we also analyzed pre F- and post F-binding BCRs isolated from a healthy blood donor with relatively high F-binding memory B cell (MBC) frequencies. Analysis of the vaccine-induced repertoires revealed that preferentially V H 4-encoded BCRs were expanded in response to vaccination. Estimation of antigen-driven selection further demonstrated that expanded BCRs accumulated positively selected replacement mutations which substantiated the hypothesis that post F-vaccination induces diversification of V H 4-encoded BCRs in germinal centers. Comparison of the vaccine-induced BCR repertoires with clonally related pre and post F-binding BCRs of the healthy blood donor suggested that the vaccine expanded pre/post F cross-reactive MBCs. Interestingly, several vaccine-induced BCRs shared stereotypic VDJ gene junctions with known neutralizing Abs. Once expressed for functional characterization, the selected monoclonal Abs demonstrated the predicted neutralization activities in plaque reduction neutralization assays indicating that the post F-vaccine induced expansion of neutralizing BCRs.",2020,"Once expressed for functional characterization, the selected monoclonal Abs demonstrated the predicted neutralization activities in plaque reduction neutralization assays indicating that the post F-vaccine induced expansion of neutralizing BCRs.",['children of less than 5 years of age which usually results in hospitalization or even in death'],['placebo'],['BCR repertoires'],"[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034789', 'cui_str': 'B-cell antigen receptor'}]",,0.110245,"Once expressed for functional characterization, the selected monoclonal Abs demonstrated the predicted neutralization activities in plaque reduction neutralization assays indicating that the post F-vaccine induced expansion of neutralizing BCRs.","[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Schneikart', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy; Department of Life Sciences, University of Siena, Via Aldo Moro 2, 53100 Siena, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Tavarini', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: simona.x.tavarini@gsk.com.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Sammicheli', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: chiara.x.sammicheli@gsk.com.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Torricelli', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: giulia.x.torricelli@gsk.com.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Guidotti', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: silvia.x.guidotti@gsk.com.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Andreano', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy; Department of Life Sciences, University of Siena, Via Aldo Moro 2, 53100 Siena, Italy. Electronic address: e.andreano@toscanalifesciences.org.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Buricchi', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: francesca.x.buricchi@gsk.com.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': ""D'Oro"", 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: ugo.x.doro@gsk.com.'}, {'ForeName': 'Oretta', 'Initials': 'O', 'LastName': 'Finco', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: oretta.x.finco@gsk.com.'}, {'ForeName': 'Monia', 'Initials': 'M', 'LastName': 'Bardelli', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: monia.x.bardelli@gsk.com.'}]",Vaccine,['10.1016/j.vaccine.2020.10.062']
1474,33131933,Immunogenicity and safety of a modified three-dose priming and booster schedule for the Hantaan virus vaccine (Hantavax): A multi-center phase III clinical trial in healthy adults.,"BACKGROUND
Hemorrhagic fever with renal syndrome is a serious health problem in Eurasian countries. This study aimed to evaluate the immunogenicity and safety of formalin-inactivated Hantaan virus vaccine (Hantavax®) with a 3 + 1 vaccination schedule.
METHODS
A phase III, multi-center clinical trial was conducted to evaluate the immunogenicity and safety of Hantavax® (three primary doses and a booster dose schedule at 0, 1, 2 and 13 months) among healthy adults. Immune responses were assessed using the plaque reduction neutralizing antibody test (PRNT) and immunofluorescent antibody assay (IFA). Systemic and local adverse events were assessed.
RESULTS
A total of 320 healthy subjects aged ≥19 years were enrolled. Following three primary doses of Hantavax®, the seroconversion rate was 80.97% and 92.81% by PRNT and IFA, respectively. With booster administration, seropositive rates were 67.47% and 95.68% at one-month post-vaccination according to PRNT and IFA, respectively. Solicited local and systemic adverse events were reported in 30.50-42.81% and 16.67-33.75% during the three primary dose vaccination, while those were reported 36.57% and 21.36% after the booster doses. Both local and systemic adverse events did not increase with repeated vaccinations.
CONCLUSION
Hantavax® showed a high seroconversion rate after the three-dose priming, and additional dose administration with 11-month interval induced good booster effects. (ClinicalTrials.gov Identifier: NCT02553837).",2020,"Solicited local and systemic adverse events were reported in 30.50-42.81% and 16.67-33.75% during the three primary dose vaccination, while those were reported 36.57% and 21.36% after the booster doses.","['320 healthy subjects aged ≥19\xa0years were enrolled', 'healthy adults', 'Hantaan virus vaccine (Hantavax']","['Hantavax®', 'formalin-inactivated Hantaan virus vaccine (Hantavax®']","['seroconversion rate', 'Immunogenicity and safety', 'immunogenicity and safety', 'Systemic and local adverse events', 'plaque reduction neutralizing antibody test (PRNT) and immunofluorescent antibody assay (IFA', 'seropositive rates', 'Solicited local and systemic adverse events']","[{'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086384', 'cui_str': 'Hantaan virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0086384', 'cui_str': 'Hantaan virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0183489', 'cui_str': 'Immunofluorescent stain'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}]",320.0,0.109589,"Solicited local and systemic adverse events were reported in 30.50-42.81% and 16.67-33.75% during the three primary dose vaccination, while those were reported 36.57% and 21.36% after the booster doses.","[{'ForeName': 'Joon Young', 'Initials': 'JY', 'LastName': 'Song', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hye Won', 'Initials': 'HW', 'LastName': 'Jeong', 'Affiliation': 'Division of Infectious Diseases, Chungbuk National University College of Medicine, Cheongju, Chungcheongbuk-do, Republic of Korea.'}, {'ForeName': 'Jong Woo', 'Initials': 'JW', 'LastName': 'Yun', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Gangwon-do, Republic of Korea.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Infectious Disease, Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Heung Jeong', 'Initials': 'HJ', 'LastName': 'Woo', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Dongtan Sacred Heart Hospital , Hallym University College of Medicine, Hwasung, Republic of Korea.'}, {'ForeName': 'Joon-Yong', 'Initials': 'JY', 'LastName': 'Bae', 'Affiliation': 'Department of Microbiology, Institute for Viral Diseases, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Man-Seong', 'Initials': 'MS', 'LastName': 'Park', 'Affiliation': 'Department of Microbiology, Institute for Viral Diseases, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Won Suk', 'Initials': 'WS', 'LastName': 'Choi', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dae Won', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Yun', 'Initials': 'JY', 'LastName': 'Noh', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Jin', 'Initials': 'HJ', 'LastName': 'Cheong', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Woo Joo', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea. Electronic address: wjkim@korea.ac.kr.'}]",Vaccine,['10.1016/j.vaccine.2020.10.035']
1475,33132076,[Effect of a hemodialysis patient education on fluid control and dietary].,"INTRODUCTION
Most chronic hemodialysis patients do not adhere to diet and fluid restrictions, source of clinical complications in the medium and long term, in some cases fatal, this study was conducted to investigate the effect of the training program given to these patients on their adherence to diet and fluid restrictions.
MATERIALS AND METHODS
The study was conducted with 50 people, split into 2 groups, set up on a control group with 25 people. No education program has been set up, and the second group with 25 people assigned to the intervention having received an education program. Data were collected using the sociodemographic characteristics questionnaire, dialysis diet and fluid non-adherence questionnaire (DDFQ), and fluid control in hemodialysis patients scale (FCHPS).
RESULTS
The measurements made at the end of the education program revealed a statistically significant difference in favor of the intervention group in terms of the mean values for the patients interdialytic weight gain (kg), ultrafilration volume and diastolic blood pressure. Similarly, the means of the scores for the 4 items of the DDFQ questionnaire revealed a statistically significant difference in favor of the intervention group concerning: the frequency of non-adherence to the diet, the degree of non-adherence to the diet, the frequency of non-adherence to liquid restriction and the degree of non-adherence to liquid restriction.
CONCLUSION
This monocentric work shows that the establishment of an educational program has a positive impact on patients adherence to dietary measures and restriction of fluids.",2020,"The measurements made at the end of the education program revealed a statistically significant difference in favor of the intervention group in terms of the mean values for the patients interdialytic weight gain (kg), ultrafilration volume and diastolic blood pressure.","['50\xa0people, split into 2\xa0groups, set up on a control group with 25\xa0people', 'chronic hemodialysis patients']","['intervention having received an education program', 'hemodialysis patient education']","['frequency of non-adherence', 'interdialytic weight gain (kg), ultrafilration volume and diastolic blood pressure', 'sociodemographic characteristics questionnaire, dialysis diet and fluid non-adherence questionnaire (DDFQ), and fluid control in hemodialysis patients scale (FCHPS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0376405', 'cui_str': 'Noncompliance with treatment'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0336604', 'cui_str': 'Patient scale'}]",,0.0201552,"The measurements made at the end of the education program revealed a statistically significant difference in favor of the intervention group in terms of the mean values for the patients interdialytic weight gain (kg), ultrafilration volume and diastolic blood pressure.","[{'ForeName': 'Abderrahim', 'Initials': 'A', 'LastName': 'Nadri', 'Affiliation': 'Service de néphrologie, hémodialyse et transplantation rénale, CHU Mohamed VI, 40000 Marrakech, Maroc. Electronic address: abderrahimnadri@gmail.com.'}, {'ForeName': 'Ayoub', 'Initials': 'A', 'LastName': 'Khanoussi', 'Affiliation': 'Service de néphrologie, hémodialyse et transplantation rénale, CHU Mohamed VI, 40000 Marrakech, Maroc.'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Hssaine', 'Affiliation': 'Service de néphrologie, hémodialyse et transplantation rénale, CHU Mohamed VI, 40000 Marrakech, Maroc.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Chettati', 'Affiliation': 'Service de néphrologie, hémodialyse et transplantation rénale, CHU Mohamed VI, 40000 Marrakech, Maroc.'}, {'ForeName': 'Wafaa', 'Initials': 'W', 'LastName': 'Fadili', 'Affiliation': 'Service de néphrologie, hémodialyse et transplantation rénale, CHU Mohamed VI, 40000 Marrakech, Maroc.'}, {'ForeName': 'Inass', 'Initials': 'I', 'LastName': 'Laouad', 'Affiliation': 'Service de néphrologie, hémodialyse et transplantation rénale, CHU Mohamed VI, 40000 Marrakech, Maroc.'}]",Nephrologie & therapeutique,['10.1016/j.nephro.2020.03.011']
1476,33132077,Investigation of the efficacy of an online tool for improving the diagnosis of macular lesions imaged by optical coherence tomography.,"PURPOSE
Optical coherence tomography (OCT) is a non-invasive method for diagnosis and monitoring of retinal (typically, macular) conditions. The unfamiliar nature of OCT images can present considerable challenges for some community optometrists. The purpose of this research is to develop and assess the efficacy of a novel internet resource designed to assist optometrists in using OCT for diagnosis of macular disease and patient management.
METHODS
An online tool (OCTAID) has been designed to assist practitioners in the diagnosis of macular lesions detected by OCT. The effectiveness of OCTAID was evaluated in a randomised controlled trial comparing two groups of practitioners who underwent an online assessment (using clinical vignettes) based on OCT images, before (exam 1) and after (exam 2) an educational intervention. Participants' answers were validated against experts' classifications (the reference standard). OCTAID was randomly allocated as the educational intervention for one group with the control group receiving an intervention of standard OCT educational material. The participants were community optometrists.
RESULTS
Random allocation resulted in 53 optometrists receiving OCTAID and 65 receiving the control intervention. Both groups performed similarly at baseline with no significant difference in mean exam 1 scores (p = 0.21). The primary outcome measure was mean improvement in exam score between the two exam modules. Participants who received OCTAID improved their exam score significantly more than those who received conventional educational materials (p = 0.005).
CONCLUSION
Use of OCTAID is associated with an improvement in the combined skill of OCT scan recognition and patient management decisions.",2020,"Participants who received OCTAID improved their exam score significantly more than those who received conventional educational materials (p = 0.005).
","['two groups of practitioners who underwent an online assessment (using clinical vignettes) based on OCT images, before (exam 1) and after (exam 2) an educational intervention']","['Optical coherence tomography (OCT', 'control group receiving an intervention of standard OCT educational material']","['mean exam 1 scores', 'mean improvement in exam score']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0523589,"Participants who received OCTAID improved their exam score significantly more than those who received conventional educational materials (p = 0.005).
","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Grace', 'Affiliation': 'London South Bank University, UK; Institute of Optometry, London, UK. Electronic address: paul@graceandoneill.com.'}, {'ForeName': 'Bruce J W', 'Initials': 'BJW', 'LastName': 'Evans', 'Affiliation': 'London South Bank University, UK; Institute of Optometry, London, UK.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Edgar', 'Affiliation': 'Division of Optometry and Visual Sciences, School of Health Sciences, City, University of London, London, United Kingdom.'}, {'ForeName': 'Praveen J', 'Initials': 'PJ', 'LastName': 'Patel', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Dhanes', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Mahon', 'Affiliation': 'Ophthalmic Imaging Dept.,RVH, Belfast, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Blake', 'Affiliation': 'Optometrist, Bury St Edmunds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bennett', 'Affiliation': 'Optometrist, Brooks and Wardman, Nottingham, UK.'}]",Journal of optometry,['10.1016/j.optom.2020.07.006']
1477,33132080,Using hypnoanalysis and guided imagery to identify and manage emotional aspects of multiple sclerosis.,"BACKGROUND
To date, no studies have used hypnosis to examine and manage the potential emotional causes of multiple sclerosis (MS) in the scientific field; therefore, we decided to compare the effectiveness of hypnoanalysis and guided imagery for determining and manage these emotional causes.
METHODS
Fifteen participants with severe MS were included and assigned into 2 groups: hypnoanalysis and guided imagery. In the hypnoanalysis group, the participants underwent 10 hypnotic sessions to understand events related to the cause of the disease, which were restructured (the events were modified by adding the psychological resources that each involved person needed); in addition, other techniques were used to investigate the causes and solutions according to the participants' unconscious. The guided imagery group received 10 group sessions of body relaxation and guided imagery, which were recorded for practice at home. Outcome measures, namely, disability (the Expanded Disability Status Scale, EDSS), quality of life (QoL, measured with the SF-36) and number of relapses, were evaluated 4 months previous the intervention, at baseline, post-intervention, and 3 months later.
RESULTS
Hypnoanalysis revealed that stressful events and psychoemotional maladaptive patterns acted as causal, detonating, or aggravating factors of disease, and psychoemotional changes were the most frequent and varied solutions. No changes were observed in disability between the two groups. The guided imagery group showed an improvement in 2 subscales of QoL when compared with the hypnoanalysis group (which disappeared at the follow-up); this difference is probably due to the increased number of sessions and probably due to psychoemotional maladaptive patterns being more frequently mentioned than difficult circumstances in life and/or unsolved past events. However, the techniques used in hypnoanalysis were effective in understanding the potential emotional causes of MS, which showed high intra- and inter-participant consistency.
CONCLUSIONS
The daily use of guided imagery overcame the restructuring of negative past events to improve QoL in patients with MS.
TRIAL REGISTRATION
ACTRN12618002024224 (retrospectively registered).",2020,The guided imagery group showed an improvement in 2 subscales of QoL when compared with the hypnoanalysis group (which disappeared at the follow-up); this difference is probably due to the increased number of sessions and probably due to psychoemotional maladaptive patterns being more frequently mentioned than difficult circumstances in life and/or unsolved past events.,"['patients with MS', 'Fifteen participants with severe MS']","['hypnoanalysis and guided imagery', 'hypnotic sessions', 'guided imagery group received 10 group sessions of body relaxation and guided imagery, which were recorded for practice at home']","['disability', '2 subscales of QoL', 'stressful events and psychoemotional maladaptive patterns acted as causal, detonating, or aggravating factors of disease, and psychoemotional changes', 'namely, disability (the Expanded Disability Status Scale, EDSS), quality of life (QoL, measured with the SF-36) and number of relapses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",15.0,0.0248955,The guided imagery group showed an improvement in 2 subscales of QoL when compared with the hypnoanalysis group (which disappeared at the follow-up); this difference is probably due to the increased number of sessions and probably due to psychoemotional maladaptive patterns being more frequently mentioned than difficult circumstances in life and/or unsolved past events.,"[{'ForeName': 'Aniel Jessica Leticia', 'Initials': 'AJL', 'LastName': 'Brambila-Tapia', 'Affiliation': 'Departamento de Psicología Básica, Centro Universitario de Ciencias de la Salud (CUCS), Universidad de Guadalajara, Sierra Mojada #950, Guadalajara, Jalisco P.C. 44340, Mexico. Electronic address: aniel.brambila@academicos.udg.mx.'}, {'ForeName': 'Maria Margarita', 'Initials': 'MM', 'LastName': 'Gutiérrez-García', 'Affiliation': 'Centro Mexicano de Programación Neurolingüística (CMPNL), Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Ruiz-Sandoval', 'Affiliation': 'Departamento de Neurología, Hospital Civil de Guadalajara ""Fray Antonio Alcalde"", Guadalajara, Jalisco, Mexico; Departamento de Neurociencias, Centro Universitario de Ciencias de la Salud (CUCS), Universidad de Guadalajara, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vázquez-Vázquez', 'Affiliation': 'Centro Mexicano de Programación Neurolingüística (CMPNL), Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Ramírez-Martínez', 'Affiliation': 'Centro Mexicano de Programación Neurolingüística (CMPNL), Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Macias-Islas', 'Affiliation': 'Departamento de Neurociencias, Centro Universitario de Ciencias de la Salud (CUCS), Universidad de Guadalajara, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Mario Alberto', 'Initials': 'MA', 'LastName': 'Mireles-Ramírez', 'Affiliation': 'Unidad Médica de Alta Especialidad (UMAE), Hospital de Especialidades, Centro Médico Nacional de Occidente, IMSS, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Andrea Dayanara', 'Initials': 'AD', 'LastName': 'De-Santos-Fonseca', 'Affiliation': 'Maestría en Psicología de la Salud, Centro Universitario de Ciencias de la Salud (CUCS), Universidad de Guadalajara, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Palomera-Chávez', 'Affiliation': 'Departamento de Psicología Básica, Centro Universitario de Ciencias de la Salud (CUCS), Universidad de Guadalajara, Sierra Mojada #950, Guadalajara, Jalisco P.C. 44340, Mexico.'}, {'ForeName': 'Rosa Martha', 'Initials': 'RM', 'LastName': 'Meda-Lara', 'Affiliation': 'Departamento de Psicología Básica, Centro Universitario de Ciencias de la Salud (CUCS), Universidad de Guadalajara, Sierra Mojada #950, Guadalajara, Jalisco P.C. 44340, Mexico.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.10.002']
1478,33132093,"Is greater trochanteric pain after primary total hip replacement approach-related? A randomized, prospective comparison of anterior versus posterior approach.","BACKGROUND
Greater trochanteric pain (GTP) after total hip replacement is a common cause of residual lateral hip pain, regardless of the approach used. The goal of our study was to evaluate GTP after a direct anterior approach (DAA) compared to a posterior approach (PA) as well as the clinical outcomes of both approaches and answer the following: 1) What is the incidence of trochanteric pain after primary THA with two different surgical approaches? 2) What is the functional outcome of patients with GTP? 3) What proportion of patients with GTP resort to peritrochanteric injections?
HYPOTHESIS
Our hypothesis is that GTP is present with both approaches but satisfaction is lower with the PA.
PATIENTS AND METHODS
Fifty-five total hip arthroplasty patients were randomized in one of two surgical approaches: 27 patients underwent the anterior modified Hueter approach, while the other group of 28 patients were operated using the posterior approach. Study outcomes were Modified Harris Hip Score (MHHS), satisfaction score, pain when lying on the affected side, and requiring an injection. Hip offset, femur lateralization and leg lengthening were measured before and after surgery.
RESULTS
Forty-five patients were available for complete follow-up at a mean of 62 months (range: 48-74). The incidence of GTP was higher in the posterior approach (PA: 29% vs DAA 17%). Patients operated through a PA experienced more pain (24% of patients; VAS=mean 5.3) when lying on their operated side, compared to DAA patients (8% of patients; VAS=mean 2). However, MHHS, patient satisfaction with surgery, radiological assessment for hip offset, femur lateralization or leg lengthening, and injections required were similar for both approaches. Overall, satisfaction and functional outcome with surgery was significantly lower in GTP patients, regardless of the approach.
CONCLUSIONS
GTP impacts patient satisfaction and functional outcome in total hip arthroplasty patients. PA patients reported more trochanteric pain than DAA patients, which affected their clinical outcome.
LEVEL OF EVIDENCE
I.",2020,"Patients operated through a PA experienced more pain (24% of patients; VAS=mean 5.3) when lying on their operated side, compared to DAA patients (8% of patients; VAS=mean 2).","['patients with GTP', 'Fifty-five total hip arthroplasty patients were randomized in one of two surgical approaches: 27 patients underwent the anterior modified Hueter approach, while the other group of 28 patients were operated using the posterior approach', 'total hip arthroplasty patients']","['GTP', 'posterior approach (PA']","['Hip offset, femur lateralization and leg lengthening', 'trochanteric pain', 'MHHS, patient satisfaction with surgery, radiological assessment for hip offset, femur lateralization or leg lengthening', 'Modified Harris Hip Score (MHHS), satisfaction score, pain when lying on the affected side, and requiring an injection', 'Overall, satisfaction and functional outcome with surgery', 'incidence of GTP', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018353', 'cui_str': 'Guanosine triphosphate'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0449446', 'cui_str': 'Surgical approach'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach'}]","[{'cui': 'C0018353', 'cui_str': 'Guanosine triphosphate'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441592', 'cui_str': 'Surgical lengthening - action'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018353', 'cui_str': 'Guanosine triphosphate'}]",45.0,0.0554636,"Patients operated through a PA experienced more pain (24% of patients; VAS=mean 5.3) when lying on their operated side, compared to DAA patients (8% of patients; VAS=mean 2).","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Moerenhout', 'Affiliation': 'Orthopedic Surgery, Department of Surgery, Hôpital Sacré-Cœur de Montréal, 5400 boulevard Gouin O., H4J 1C5 Montréal, Québec, Canada; Department of Orthopaedics and Traumatology, Lausanne University Hospital, rue du Bugnon 46, CH-1011 Lausanne, Switzerland. Electronic address: kevin.moerenhout@chuv.ch.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Benoit', 'Affiliation': 'Orthopedic Surgery, Department of Surgery, Hôpital Sacré-Cœur de Montréal, 5400 boulevard Gouin O., H4J 1C5 Montréal, Québec, Canada.'}, {'ForeName': 'Henry S', 'Initials': 'HS', 'LastName': 'Gaspard', 'Affiliation': 'Orthopedic Surgery, Hull Hospital, 116, boulevard Lionel-Émond, J8Y 1W7 Gatineau, Québec, Canada.'}, {'ForeName': 'Dominique M', 'Initials': 'DM', 'LastName': 'Rouleau', 'Affiliation': 'Orthopedic Surgery, Department of Surgery, Hôpital Sacré-Cœur de Montréal, 5400 boulevard Gouin O., H4J 1C5 Montréal, Québec, Canada.'}, {'ForeName': 'G Yves', 'Initials': 'GY', 'LastName': 'Laflamme', 'Affiliation': 'Orthopedic Surgery, Department of Surgery, Hôpital Sacré-Cœur de Montréal, 5400 boulevard Gouin O., H4J 1C5 Montréal, Québec, Canada.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.08.011']
1479,33132094,Mid-term gender-specific differences in periprosthetic bone remodelling after implantation of a curved bone-preserving hip stem.,"BACKGROUND
The implant-specific periprosthetic bone remodelling in the proximal femur is considered to be an important factor influencing the long-term survival of cementless hip stems. Particularly data of gender-specific differences regarding bone-preserving stems are very rare in literature and mainly limited to short-term investigations. Therefore, we investigated at mid-term one arm of a prospective randomised study to evaluate if there is an influence of gender on implant-specific stress shielding after implantation of a curved bone preserving hip stem (Fitmore) 5 years postoperatively.
HYPOTHESIS
We hypothesised there will be no gender-specific differences in periprosthetic bone remodelling.
PATIENTS AND METHODS
A total of 20 female and 37 male patients underwent total hip arthroplasty using the Fitmore stem. Clinical, radiological as well as osteodensitometric examinations were performed preoperatively, 7 days and 3, 12 and 60 months postoperatively. Clinical data collection included the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the Harris Hip Score (HHS). Periprosthetic bone mineral density (BMD) was measured using Dual Energy X-ray Absorptiometry (DXA) and the periprosthetic bone was divided into 7 regions of interest (ROI) for analysis. The results at 3, 12 and 60 months were compared with the first postoperative measurement after 7 days to obtain a percentage change.
RESULTS
Periprosthetic BMD showed a decrease in all 7 ROIs for both groups 5 years postoperatively referred to the baseline value, except ROI 3 (0.8%, p=0.761), representing the distal lateral part of the stem, and ROI 5 (0.3%, p=0.688), representing the distal medial part of the stem in the male cohort. Significant gender differences were found in ROI 1 (-16.0% vs. -3.5%, p=0.016) and ROI 6 (-9.9% vs. -2.1%, p=0.04) in favour of the male patients. Clinical results showed no significant gender differences 5 years postoperatively with regard to WOMAC (mean 0.4 (±0.8, 0-3.3) in women vs. 0.3 (±0.8, 0-4.2) in men, p=0.76) and HHS (mean 93.0 (±9.7, 66.0-100.0) in women vs. 93.9 (±11.5, 53.0-100.0) in men, p=0.36).
CONCLUSION
Proximal stress shielding was observed independent of gender 5 years postoperatively. However, there was a significantly lower bone loss proximal lateral and medial below the calcar in male patients, indicating a more physiological load transfer. [ClinicalTrials.gov identifier: NCT03147131 (Study ID D.3067-244/10). Registered 10 May 2017 - retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03147131?term=Bieger&draw=2&rank=1] LEVEL OF EVIDENCE: IV; prospective study without control group.",2020,"RESULTS
Periprosthetic BMD showed a decrease in all 7 ROIs for both groups 5 years postoperatively referred to the baseline value, except ROI 3 (0.8%, p=0.761), representing the distal lateral part of the stem, and ROI 5 (0.3%, p=0.688), representing the distal medial part of the stem in the male cohort.","['20 female and 37 male patients underwent', 'male patients']","['total hip arthroplasty using the Fitmore stem', 'implant-specific stress shielding after implantation of a curved bone preserving hip stem (Fitmore) 5 years postoperatively', 'curved bone-preserving hip stem']","['Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the Harris Hip Score (HHS', 'ROI 1', 'HHS', 'Periprosthetic BMD', 'WOMAC', 'Periprosthetic bone mineral density (BMD']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",20.0,0.0574682,"RESULTS
Periprosthetic BMD showed a decrease in all 7 ROIs for both groups 5 years postoperatively referred to the baseline value, except ROI 3 (0.8%, p=0.761), representing the distal lateral part of the stem, and ROI 5 (0.3%, p=0.688), representing the distal medial part of the stem in the male cohort.","[{'ForeName': 'Julian Stefan', 'Initials': 'JS', 'LastName': 'Meyer', 'Affiliation': 'Department of orthopaedic surgery, University of Ulm, Oberer Eselsberg 45, 89081 Ulm, Germany; Department of orthopaedic surgery, Koenig-Ludwig-Haus, University of Wuerzburg, Brettreichstraße 11, 97074 Wuerzburg, Germany. Electronic address: jsmeyer@mail.de.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Freitag', 'Affiliation': 'Department of orthopaedic surgery, University of Ulm, Oberer Eselsberg 45, 89081 Ulm, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Reichel', 'Affiliation': 'Department of orthopaedic surgery, University of Ulm, Oberer Eselsberg 45, 89081 Ulm, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Bieger', 'Affiliation': 'Department of orthopaedic surgery, University of Ulm, Oberer Eselsberg 45, 89081 Ulm, Germany.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.04.023']
1480,33132112,Effect of health-promoting messages in television food commercials on adolescents' attitudes and consumption: A randomized intervention study.,"INTRODUCTION
The HAVISA plan is a Spanish government's policy for the promotion of healthy lifestyles via health messages in television food advertisements. This study evaluated the positive or negative impact (health halo effect) of health messages on food choices and predisposition towards healthy habits of Spanish adolescents.
METHODS
Randomized controlled study in 11-14 years old adolescents. The intervention group watched television advertisements for unhealthy foods with HAVISA health messages, while the control group watched the same advertisements without them. A self-administered questionnaire measured participants' attitudes towards the products advertised, to diet and physical activity, and recognition of messages. Afterwards they chose between fruit and unhealthy snacks. The differences between the two groups were then compared.
RESULTS
A total of 27.2% of the control group versus 29.6% of the intervention group chose fruit (p = 0.54). Both groups displayed high desire for (7.24 vs. 7.40, p = 0.29) and intention to consume (6.67 vs. 6.73, p = 0.63) the unhealthy products advertised. There were no differences in perceived healthiness of these foods (4.11 vs. 4.19, p = 0.74), or perceived importance of a healthy diet (3.17 vs. 3.12, p = 0.55) or physical activity (4.53 vs. 4.51, p = 0.73). Desire for vegetables (2.49 vs. 2.66, p = 0.08) and fruit (3.15 vs. 3.30, p = 0.09) were higher in the intervention group, but the differences were not significant. Only 47.6% of participants noticed the presence of health messages; of these, 31% correctly recalled their content.
CONCLUSION
HAVISA health messages changed neither the attitudes nor immediate eating behaviors of adolescents. There was no immediate healthy-lifestyle promoter or adverse health halo effect, probably due to the messages' low prominence. Further research should evaluate the long-term effect of repeated exposure to health messages.",2020,"Desire for vegetables (2.49 vs. 2.66, p = 0.08) and fruit (3.15 vs. 3.30, p = 0.09) were higher in the intervention group, but the differences were not significant.","['11-14 years old adolescents', ""adolescents' attitudes and consumption"", 'healthy habits of Spanish adolescents']","['health messages', 'intervention group watched television advertisements for unhealthy foods with HAVISA health messages, while the control group watched the same advertisements without them', 'health-promoting messages']","['Desire for vegetables', 'presence of health messages', 'physical activity']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0628519,"Desire for vegetables (2.49 vs. 2.66, p = 0.08) and fruit (3.15 vs. 3.30, p = 0.09) were higher in the intervention group, but the differences were not significant.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fernández-Escobar', 'Affiliation': 'Escuela Nacional de Sanidad, Instituto de Salud Carlos III. Calle Sinesio Delgado 10, 28029, Madrid, Spain. Electronic address: carlos.fe.es@gmail.com.'}, {'ForeName': 'Doris Xiomara', 'Initials': 'DX', 'LastName': 'Monroy-Parada', 'Affiliation': 'Escuela Nacional de Sanidad, Instituto de Salud Carlos III. Calle Sinesio Delgado 10, 28029, Madrid, Spain. Electronic address: doxiomonpa1@gmail.com.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ordaz Castillo', 'Affiliation': 'Escuela Nacional de Sanidad, Instituto de Salud Carlos III. Calle Sinesio Delgado 10, 28029, Madrid, Spain. Electronic address: eordaz@isciii.es.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lois', 'Affiliation': 'Social Psychology Department, Universidad Nacional de Educación a Distancia, Calle de Juan Del Rosal, 10, 28040, Madrid, Spain. Electronic address: davidlois@psi.uned.es.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Royo-Bordonada', 'Affiliation': 'Escuela Nacional de Sanidad, Instituto de Salud Carlos III. Calle Sinesio Delgado 10, 28029, Madrid, Spain. Electronic address: mroyo@isciii.es.'}]",Appetite,['10.1016/j.appet.2020.105014']
1481,33132156,Characterization of retinal microvasculature and its relations to cognitive function in older people after circuit resistance training.,"PURPOSE
To characterize the changes of retinal microvascular density and their relations to cognitive function in the healthy older people without known cognitive impairment after an 8-week high-speed circuit resistance training program (HSCT).
METHODS
Twenty cognitively normal older people were recruited and randomly assigned to either the HSCT group or control group (CON). Twelve subjects (age 70.8 ± 5.8 yrs) in the HSCT group trained three times per week for 8 weeks. Eight subjects in the CON group (age 71.8 ± 4.8 yrs) did not perform formal training. Both eyes of each subject were imaged using optical coherence tomography angiography (OCTA) at baseline and at 8-week follow-up. The densities of the retinal vascular network (RVN), superficial vascular plexus (SVP), and deep vascular plexus (DVP) were measured. In addition, their cognitive functions were tested using the NIH toolbox.
RESULTS
There were significant increases in pattern comparison processing speed (PAT, P = 0.02) and fluid composite score (FCS, P = 0.005) at the follow-up in the HSCT group. Although the vessel densities did not differ between visits in either group, the variation (i.e., change) in retinal vessel density of SVP was negatively related to the changes of FCS (r = -0.54, P = 0.007) and the List Sorting Working Memory test (r = -0.43, P = 0.039) in the HSCT group.
CONCLUSIONS
This is the first study to reveal that the individual response of the SVD was related to the improvement in the cognition in cognitively normal older people after HSCT.",2020,"There were significant increases in pattern comparison processing speed (PAT, P = 0.02) and fluid composite score (FCS, P = 0.005) at the follow-up in the HSCT group.","['Eight subjects in the CON group (age 71.8\xa0±\xa04.8\xa0yrs) did not perform formal training', 'healthy older people without known cognitive impairment after an 8-week high', 'cognitively normal older people after HSCT', 'Twenty cognitively normal older people', 'Twelve subjects (age 70.8\xa0±\xa05.8\xa0yrs) in the', 'older people after circuit resistance training']","['optical coherence tomography angiography (OCTA', 'HSCT group or control group (CON', 'speed circuit resistance training program (HSCT', 'HSCT']","['List Sorting Working Memory test', 'vessel densities', 'pattern comparison processing speed (PAT, P\xa0=\xa00.02) and fluid composite score', 'retinal vessel density of SVP', 'densities of the retinal vascular network (RVN), superficial vascular plexus (SVP), and deep vascular plexus (DVP']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4517796', 'cui_str': '5.8'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035330', 'cui_str': 'Structure of blood vessel of retina'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",20.0,0.0222647,"There were significant increases in pattern comparison processing speed (PAT, P = 0.02) and fluid composite score (FCS, P = 0.005) at the follow-up in the HSCT group.","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fang', 'Affiliation': 'Shenzhen Key Laboratory of Ophthalmology, Shenzhen Eye Hospital, Jinan University, Shenzhen, China; Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Keri', 'Initials': 'K', 'LastName': 'Strand', 'Affiliation': 'Department of Kinesiology and Sports Sciences, University of Miami, FL, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA; School of Ophthalmology and Optometry, Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Totillo', 'Affiliation': 'Department of Kinesiology and Sports Sciences, University of Miami, FL, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA; School of Ophthalmology and Optometry, Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Signorile', 'Affiliation': 'Department of Kinesiology and Sports Sciences, University of Miami, FL, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA; Department of Neurology, University of Miami Miller School of Medicine, Miami, FL, USA. Electronic address: hjiang@med.miami.edu.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA.'}]",Experimental gerontology,['10.1016/j.exger.2020.111114']
1482,33132228,Dabigatran vs. Aspirin for Secondary Prevention After Embolic Stroke of Undetermined Source - Japanese Subanalysis of the RE-SPECT ESUS Randomized Controlled Trial.,"BACKGROUND
The international Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate versus Acetylsalicylic Acid in Patients with Embolic Stroke of Undetermined Source (RE-SPECT ESUS) trial did not demonstrate superiority of dabigatran over aspirin for reduction of recurrent strokes in patients with embolic strokes of undetermined source (ESUS). Based on pre-defined subanalyses, the safety and efficacy of dabigatran vs. aspirin in Japanese patients was assessed.Methods and Results:ESUS patients were randomized to receive either dabigatran (150 or 110 mg twice daily) or aspirin (100 mg once daily). Of 5,390 patients randomized, 594 were Japanese. Most Japanese patients (99.8%) underwent brain magnetic resonance imaging for trial screening, compared to 76.8% of non-Japanese (P<0.0001). In the Japanese cohort, over a 19.4-month median follow-up period, recurrent stroke as the primary outcome occurred in 20/294 patients (4.3%/year) in the dabigatran group and 38/300 (8.3%/year) in the aspirin group (hazard ratio [HR], 0.55; 95% confidence interval [CI], 0.32-0.94). Major bleeding occurred in 12 patients (2.5%/year) and 17 patients (3.5%/year), respectively (HR, 0.72; 95% CI, 0.34-1.52). In contrast, in the non-Japanese cohort, recurrent stroke occurred in 4.1%/year and 4.3%/year, respectively, showing no apparent difference in recurrent stroke for dabigatran vs. aspirin (HR, 0.91; 95% CI, 0.74-1.14). The P-interaction for treatment and region did not reach statistical significance (P=0.09).
CONCLUSIONS
Dabigatran was putatively associated with a lower relative risk of recurrent stroke compared with aspirin in Japanese ESUS patients.",2020,"Major bleeding occurred in 12 patients (2.5%/year) and 17 patients (3.5%/year), respectively (HR, 0.72; 95% CI, 0.34-1.52).","['Japanese ESUS patients', 'Patients with Embolic Stroke of Undetermined Source (RE-SPECT ESUS', 'patients with embolic strokes of undetermined source (ESUS', '5,390 patients randomized, 594 were Japanese', 'Japanese patients']","['brain magnetic resonance imaging', 'dabigatran over aspirin', 'dabigatran', 'Oral Thrombin Inhibitor Dabigatran Etexilate versus Acetylsalicylic Acid', 'Dabigatran vs. Aspirin', 'aspirin', 'dabigatran vs. aspirin']","['Major bleeding', 'safety and efficacy', 'recurrent stroke']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}]",5390.0,0.374949,"Major bleeding occurred in 12 patients (2.5%/year) and 17 patients (3.5%/year), respectively (HR, 0.72; 95% CI, 0.34-1.52).","[{'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'National Cerebral and Cardiovascular Center.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'International University of Health and Welfare, Sanno Hospital and Sanno Medical Center.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Hagihara', 'Affiliation': 'Rinku General Medical Center.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kuwashiro', 'Affiliation': 'National Hospital Organization, Kyushu Medical Center.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Mori', 'Affiliation': 'Shonan Kamakura General Hospital.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kamiyama', 'Affiliation': 'Nakamura Memorial Hospital.'}, {'ForeName': 'Yasuhisa', 'Initials': 'Y', 'LastName': 'Urano', 'Affiliation': 'Nippon Boehringer Ingelheim Co, Ltd.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Taniguchi', 'Affiliation': 'Nippon Boehringer Ingelheim Co, Ltd.'}, {'ForeName': 'Kenma', 'Initials': 'K', 'LastName': 'Nozaki', 'Affiliation': 'Nippon Boehringer Ingelheim Co, Ltd.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cronin', 'Affiliation': 'Boehringer Ingelheim Ltd.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Grauer', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co KG.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'University Duisburg-Essen and University Hospital Essen.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-20-0563']
1483,33132302,Development and validation of a new prognostic score system for COVID-19.,"This study aimed to develop and validate a bedside risk analysis system for predicting the clinical severity and prognosis of patients with COVID-19. A total of 444 COVID-19 patients were included and were randomly assigned into two groups at a ratio of 2:1 as derivation and validation groups. The new scoring system comprised of eight variables, which included history of having malignant diseases, history of having diabetes mellitus, dyspnea, respiratory rate of >24 bpm, C-reactive protein (CRP) of >14 mg/L, white blood cell count of >8×10 9 /L, platelets count of <180×10 12 /L, and lymphocyte count of <1×10 9 /L. The sensitivity analysis revealed that this new score performed better than the sequential organ failure assessment (SOFA) score at the first day of admission. The receiver characteristic curve analysis revealed that this score predicted severe cases of COVID-19 infection at 0.831 (95% confidence interval: 0.783-0.879) and 0.798 (95% confidence interval: 0.727-0.869) of the area under the curve in the derivation and validation group. The proposed risk score system is a fairly reliable and robust tool for evaluating the severity and prognosis of patients with COVID-19. This may help to early identify severe patients with poor prognosis, who may require more intense interventions.",2020,The proposed risk score system is a fairly reliable and robust tool for evaluating the severity and prognosis of patients with COVID-19.,"['patients with COVID-19', '8×10 9', 'severe patients with poor prognosis', 'included history of having malignant diseases, history of having diabetes mellitus, dyspnea, respiratory rate of >24 bpm, C-reactive protein (CRP) of >14 mg/L, white blood cell count of ', 'A total of 444 COVID-19 patients']",[],"['COVID-19 infection', 'L, platelets count of <180×10 12 /L, and lymphocyte count', 'sequential organ failure assessment (SOFA) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",444.0,0.0435316,The proposed risk score system is a fairly reliable and robust tool for evaluating the severity and prognosis of patients with COVID-19.,"[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'Department of Pediatrics, the First Hospital of Jilin University, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Gastrointestinal, the First Hospital of Jilin University, China.'}, {'ForeName': 'Boqi', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of Radiology, China-Japan Union Hospital of Jilin University, China.'}, {'ForeName': 'Yingli', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal, the First Hospital of Jilin University, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal, the First Hospital of Jilin University, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal, the First Hospital of Jilin University, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal, the First Hospital of Jilin University, China.'}]",Japanese journal of infectious diseases,['10.7883/yoken.JJID.2020.718']
1484,33132344,"Visceral Fat-Reducing Effect and Safety of Continuous Consumption of Beverage Containing Resistant Maltodextrin: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial.","Obesity is regarded as a global concern with increasing prevalence, most notably in developed countries. Metabolic syndrome is a predictor of cardiovascular disease and type 2 diabetes mellitus and is defined as the accumulation of multiple risk factors caused by abdominal visceral obesity. Resistant maltodextrin (RMD) is a soluble dietary fiber that has been shown to reduce visceral fat in long-term clinical trials when continuously administered at 10 g, three times daily. Herein, we evaluated the effects of long-term consumption of 5 g RMD three times daily. A total of 140 healthy adults were randomly assigned to two intervention groups for a 12-wk randomized, double-blind, placebo-controlled, parallel-group trial. Participants ingested a test beverage containing 5 g RMD or a placebo beverage without RMD. Interviews, anthropometric measurements, physiological examination, blood tests, and urinalyses were conducted at baseline and every 4 wk during the trial. Computed tomography scans were performed at baseline and at the end of week 8 and 12. Results showed that abdominal visceral fat area (VFA) significantly decreased in the test group from 105.33±26.83 cm 2 at baseline to 101.15±24.33 cm 2 at week 12. Further, a significant difference was observed in the VFA between the test and control groups (p<0.05), confirming the function of continuous RMD consumption in reducing abdominal visceral fat. Furthermore, neither serious adverse events nor adverse clinical findings were observed in the blood or urine tests following consumption of RMD, suggesting that continuous consumption of RMD containing beverages is safe.",2020,"Furthermore, neither serious adverse events nor adverse clinical findings were observed in the blood or urine tests following consumption of RMD, suggesting that continuous consumption of RMD containing beverages is safe.",['140 healthy adults'],"['placebo beverage without RMD', 'Continuous Consumption of Beverage Containing Resistant Maltodextrin', 'placebo', 'Resistant maltodextrin (RMD', 'Placebo']","['abdominal visceral fat area (VFA', 'VFA', 'abdominal visceral fat', 'Interviews, anthropometric measurements, physiological examination, blood tests, and urinalyses']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}]",140.0,0.370621,"Furthermore, neither serious adverse events nor adverse clinical findings were observed in the blood or urine tests following consumption of RMD, suggesting that continuous consumption of RMD containing beverages is safe.","[{'ForeName': 'Machiko', 'Initials': 'M', 'LastName': 'Kitagawa', 'Affiliation': 'Matsutani Chemical Industry Co., Ltd.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Nakagawa', 'Affiliation': 'Coca-Cola (Japan) Co., Ltd.'}, {'ForeName': 'Takuto', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Coca-Cola Tokyo Research & Development Co., Ltd.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Kishimoto', 'Affiliation': 'Matsutani Chemical Industry Co., Ltd.'}, {'ForeName': 'Sumiko', 'Initials': 'S', 'LastName': 'Kanahori', 'Affiliation': 'Matsutani Chemical Industry Co., Ltd.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Hatakeyama', 'Affiliation': 'New Drug Research Center Inc.'}, {'ForeName': 'Shimpei', 'Initials': 'S', 'LastName': 'Tomita', 'Affiliation': 'New Drug Research Center Inc.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Fukuhara', 'Affiliation': 'Fukuhara Clinic.'}]",Journal of nutritional science and vitaminology,['10.3177/jnsv.66.417']
1485,33132345,Effects of Acute Grape Seed Extract Supplementation on Hemodynamics in Normal Body Weight and Obese Males.,"Recently, it has been reported that dietary supplementation with grape seed extract (GSE) ameliorates endothelial function and increase nitric oxide (NO) bioavailability. Thus, we investigated if elevated blood pressure and aortic stiffness (AoS) characterized in obese individuals are attenuated following acute GSE supplementation. Twenty men (obese=10; normal body weight (NBW)=10) participated in this study. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO), total peripheral resistance (TPR), and AoS were compared 2 h after ingestion of GSE or placebo (PL) on different days, 1 wk apart. Compared with the PL, GSE supplementation significantly decreased SBP (NBW: 103±4 vs. 99±3 mmHg; obese: 118±3 vs. 112±5 mmHg) and MAP (NBW: 75±2 vs. 72±2 mmHg; obese: 86±3 vs. 84±3 mmHg) in both groups, while there were no differences in HR, SV, DBP, TPR, and AoS. GSE supplementation significantly decreased CO in only obese group. In NBW group, TPR tended to be decreased, but there was no significant difference. Our study suggests that acute supplementation with GSE reduced both SBP and MAP via a reduction in CO in obese individuals and decreased peripheral vasoconstriction in NBW group.",2020,"In NBW group, TPR tended to be decreased, but there was no significant difference.","['Normal Body Weight and Obese Males', 'obese individuals', 'Twenty men (obese=10; normal body weight (NBW)=10) participated in this study']","['dietary supplementation with grape seed extract (GSE', 'GSE or placebo', 'PL, GSE supplementation', 'Acute Grape Seed Extract Supplementation', 'GSE']","['Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO), total peripheral resistance (TPR), and AoS', 'nitric oxide (NO) bioavailability', 'HR, SV, DBP, TPR, and AoS. GSE supplementation significantly decreased CO', 'elevated blood pressure and aortic stiffness (AoS', 'TPR', 'SBP (NBW', 'peripheral vasoconstriction']","[{'cui': 'C0421272', 'cui_str': 'Ideal body weight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0772454', 'cui_str': 'Grape Seed Extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0772454', 'cui_str': 'Grape Seed Extract'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0007166', 'cui_str': 'Decreased cardiac output'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0421272', 'cui_str': 'Ideal body weight'}, {'cui': 'C0235248', 'cui_str': 'Peripheral vasoconstriction'}]",20.0,0.106629,"In NBW group, TPR tended to be decreased, but there was no significant difference.","[{'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Dillon', 'Affiliation': 'Department of Kinesiology, California Baptist University.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Shariffi', 'Affiliation': 'Department of Kinesiology, California Baptist University.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Thompson', 'Affiliation': 'Department of Kinesiology, California Baptist University.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Steele', 'Affiliation': 'Department of Kinesiology, California Baptist University.'}, {'ForeName': 'Jong-Kyung', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Kinesiology, California Baptist University.'}]",Journal of nutritional science and vitaminology,['10.3177/jnsv.66.427']
1486,33132386,Comparative Evaluation of Two Hyaluronic Acid Gel Products for the Treatment of Interdental Papillary Defects.,"Objectives
The aim was to investigate the efficacy of single injections of two different hyaluronic acid products, Flex Barrier and Revident, in reducing the size of black triangles to treat Nordland-Tarnow Class I and II recessions.
Materials and Methods
Forty adult patients were recruited with at least two upper and two lower interdental papilla defects in the front region between canine teeth. According to the Nordland-Tarnow classification of papillary defects, both Class I and Class II recessions were included in the investigation. Patients were randomly assigned to experimental groups to receive single injections of two different hyaluronic acid products, either Flex Barrier or Revident. The untreated sites served as controls. Photographs were taken before and immediately after the treatment, and again after one week and one month. To determine the size of the black triangles, Image J software was used. For statistical analysis, a mixed-design ANOVA was applied.
Results
Both Flex Barrier and Revident significantly decreased the size of the treated defects immediately after the treatment and also one week later (p<0.001). The beneficial effect of Revident lasted longer than Flex Barrier as it remained significant even after one month in Revident-treated patients, however, not in the Flex Barrier-treated group. Furthermore, Nordland-Tarnow Class I lesions generally showed a greater improvement than Class II lesions.
Conclusion
In this proof-of-concept, randomized clinical trial we have demonstrated the clinical applicability of both Flex Barrier and Revident, although Revident gave longer-lasting improvements than Flex Barrier. Further trials are needed to optimize multiple-application protocols for treating gingival black triangles.",2020,Both Flex Barrier and Revident significantly decreased the size of the treated defects immediately after the treatment and also one week later (p<0.001).,"['Interdental Papillary Defects', 'Materials and Methods\n\n\nForty adult patients were recruited with at least two upper and two lower interdental papilla defects in the front region between canine teeth']","['Two Hyaluronic Acid Gel Products', 'hyaluronic acid products, Flex Barrier and Revident', 'hyaluronic acid products, either Flex Barrier or Revident']",[],"[{'cui': 'C0442104', 'cui_str': 'Interdental'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1185949', 'cui_str': 'Structure of interdental papilla of gingiva'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",[],40.0,0.0154253,Both Flex Barrier and Revident significantly decreased the size of the treated defects immediately after the treatment and also one week later (p<0.001).,"[{'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Mandel', 'Affiliation': '- University of Pécs, Medical School, Department of Dentistry, Oral and Maxillofacial Surgery, Pécs, Hungary.'}, {'ForeName': 'Sándor', 'Initials': 'S', 'LastName': 'Farkasdi', 'Affiliation': '- Semmelweis University, Faculty of Dentistry, Department of Oral Biology, Budapest, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Varga', 'Affiliation': '- Semmelweis University, Faculty of Dentistry, Department of Oral Biology, Budapest, Hungary.'}, {'ForeName': 'Ákos Károly', 'Initials': 'ÁK', 'LastName': 'Nagy', 'Affiliation': '- University of Pécs, Medical School, Department of Dentistry, Oral and Maxillofacial Surgery, Pécs, Hungary.'}]",Acta stomatologica Croatica,['10.15644/asc54/3/1']
1487,33132388,Evaluation of the Antibacterial Effects of Single and Combined use of Different Irrigation Solutions Against Intracanal Enterococcus Faecalis .,"Objectives
This study assessed the antibacterial activity of both separate and combined uses of 5.25% sodium hypochlorite (NaOCl), 2% chlorhexidine (CHX), 17% ethylenediaminetetraacetic acid (EDTA), 3% hydrogen peroxide (H 2 O 2 ), MTAD, SmearClear (SC) and 13.8% chlorine dioxide (ClO 2 ) irrigation solutions against Enterococcus faecalis.
Materials and Methods
Two hundred eighty single rooted human premolars were randomly grouped into 26 test and 2 control (negative and positive) groups and were incubated for 24 h with E. faecalis , except for the negative control group. The tested solutions were as follow: NaOCl; CHX; ClO 2 ; MTAD; SC; EDTA; H 2 O 2 ; NaOCl + CHX; NaOCl + MTAD; SC + NaOCl; EDTA + NaOCl; H 2 O 2 + NaOCl; ClO 2 + CHX; CHX + MTAD; SC + CHX; EDTA + CHX; CHX + H 2 O 2 ; ClO 2 + MTAD; SC + ClO 2 ; EDTA + ClO 2 ; ClO 2 + H 2 O 2 ; SC+MTAD; EDTA+MTAD; MTAD + H 2 O 2 ; SC + H 2 O 2; and EDTA + H 2 O 2. Optic density values were recorded at 0, 6, 12, 18, 24, 30, 36, 42 and 48 h and bacterial growth curve created for each solution.
Results
The CHX, MTAD and ClO 2 showed a high potential for the elimination of E. faecalis, both alone and in all combinations. The EDTA, H 2 O 2 , H 2 O 2 + EDTA, H 2 O 2 + NaOCl and SC + NaOCl groups showed less antibacterial activity than the other groups. The SC + CHX group showed the best antibacterial effect against E. faecalis .
Conclusion
The SC + CHX combination can be recommended as the most effective irrigation regimen against E. faecalis in persistent endodontic infections.",2020,"The CHX, MTAD and ClO 2 showed a high potential for the elimination of E. faecalis, both alone and in all combinations.",['Two hundred eighty single rooted human premolars'],"['SC + CHX', '5.25% sodium hypochlorite (NaOCl), 2% chlorhexidine (CHX), 17% ethylenediaminetetraacetic acid (EDTA), 3% hydrogen peroxide (H 2 O 2 ), MTAD, SmearClear (SC) and 13.8% chlorine dioxide (ClO 2 ) irrigation solutions', 'NaOCl + CHX; NaOCl + MTAD; SC + NaOCl; EDTA + NaOCl; H 2 O 2 + NaOCl; ClO 2 + CHX; CHX + MTAD; SC + CHX; EDTA + CHX; CHX + H']","['antibacterial effect against E. faecalis ', 'antibacterial activity', 'Optic density values']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C0055370', 'cui_str': 'chlorine dioxide'}, {'cui': 'C0122922', 'cui_str': 'Hypochlorite'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}]","[{'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",280.0,0.0515488,"The CHX, MTAD and ClO 2 showed a high potential for the elimination of E. faecalis, both alone and in all combinations.","[{'ForeName': 'Hatice Buyukozer', 'Initials': 'HB', 'LastName': 'Ozkan', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Alanya Alaaddin Keykubat University, Alanya, Antalya, Turkey.'}, {'ForeName': 'Funda Kont', 'Initials': 'FK', 'LastName': 'Cobankara', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Zafer', 'Initials': 'Z', 'LastName': 'Sayin', 'Affiliation': 'Department of Microbiology, Faculty of Veterinary Medicine, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Fusun', 'Initials': 'F', 'LastName': 'Ozer', 'Affiliation': 'Department of Preventive and Restorative Sciences, School of Dental Medicine University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Acta stomatologica Croatica,['10.15644/asc54/3/3']
1488,33104504,Patient-Preferred Prosthetic Ankle-Foot Alignment for Ramps and Level-Ground Walking.,"Patient preference of lower limb prosthesis behavior informally guides clinical decision making, and may become increasingly important for tuning new robotic prostheses. However, the processes for quantifying preference are still being developed, and the strengths and weaknesses of preference are not adequately understood. The present study sought to characterize the reliability (consistency) of patient preference of alignment during level-ground walking, and determine the patient-preferred ankle angle for ascent and descent of a 10° ramp, with implications for the design and control of robotic prostheses. Seven subjects with transtibial amputation walked over level ground, and ascended and descended a 10° ramp on a semi-active prosthetic ankle capable of unweighted repositioning in dorsiflexion and plantarflexion. Preferred ankle angle was measured with an adaptive forced-choice psychophysics paradigm, in which subjects walked on a randomized static ankle angle and reported whether they would prefer the ankle to be dorsiflexed or plantarflexed. Subjects had reliable preferences for alignment during level-ground walking, with deviations of 1.5° from preference resulting in an 84% response rate preferring changes toward the preference. Relative to level walking, subjects preferred 7.8° (SD: 4.8°) of dorsiflexion during ramp ascent, and 5.3° (SD: 3.8°) plantarflexion during ramp descent. As the ankle angle better matched the ramp angle, socket pressures and tibial progression (shank pitch) both more closely mirrored those during level walking. These findings provide baseline behaviors for prosthetic ankles capable of adapting to slopes based on patient preference, and provide strong evidence that people with transtibial amputation can finely perceive ankle alignment.",2020,"As the ankle angle better matched the ramp angle, socket pressures and tibial progression (shank pitch) both more closely mirrored those during level walking.","['Seven subjects with transtibial amputation walked over level ground, and ascended and descended a 10']",['° ramp on a semi-active prosthetic ankle capable of unweighted repositioning in dorsiflexion and plantarflexion'],['socket pressures and tibial progression (shank pitch'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}]","[{'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}]","[{'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444675', 'cui_str': 'Shank'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}]",7.0,0.036168,"As the ankle angle better matched the ramp angle, socket pressures and tibial progression (shank pitch) both more closely mirrored those during level walking.","[{'ForeName': 'Max K', 'Initials': 'MK', 'LastName': 'Shepherd', 'Affiliation': ''}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Simon', 'Affiliation': ''}, {'ForeName': 'Joey', 'Initials': 'J', 'LastName': 'Zisk', 'Affiliation': ''}, {'ForeName': 'Levi', 'Initials': 'L', 'LastName': 'Hargrove', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2020.3033711']
1489,33104519,Aerobic exercise induces tumor suppressor p16 INK4a expression of endothelial progenitor cells in human skeletal muscle.,"Aerobic exercise induces oxidative stress and DNA damage, nevertheless, lowers cancer incidence. It remains unclear how genetic stability is maintained under this condition. Here, we examined the dynamic change of the tumor suppressor p16 INK4a in cells of skeletal muscle among young men following 60-min of aerobic cycling at 70% maximal oxygen consumption (V̇O 2max ). Rg1 (5 mg, an immunostimulant ginsenoside) and placebo (PLA) were supplemented 1 h before exercise. Data from serial muscle biopsies shows unchanged p16 INK4a+ cells after exercise followed by a considerable increase (+21-fold) in vastus lateralis muscle 3 h later. This increase was due to the accumulation of endothelial progenitor cells (p16 INK4a+ /CD34 + ) surrounding myofibers and other infiltrated nucleated cells (p16 INK4a+ /CD34 - ) in necrotic myofibers. During the Rg1 trial, acute increases of p16 INK4a+ cells in the muscle occurred immediately after exercise (+3-fold) and reversed near baseline 3 h later. Rg1 also lowered IL-10 mRNA relative to PLA 3 h after exercise. Post-exercise increases in VEGF mRNA and CD163 + macrophages were similar for PLA and Rg1 trials. Conclusion: The marked increases in p16 INK4a protein expression of endothelial progenitor cells in skeletal muscle implicates a protective mechanism for maintaining genetic stability against aerobic exercise. Rg1 accelerates resolution of the exercise-induced stress response.",2020,"During the Rg1 trial, acute increases of p16 INK4a+ cells in the muscle occurred immediately after exercise (+3-fold) and reversed near baseline 3 h later.",['human skeletal muscle'],"['Aerobic exercise', 'placebo (PLA']","['accumulation of endothelial progenitor cells', 'oxidative stress and DNA damage, nevertheless, lowers cancer incidence', 'VEGF mRNA and CD163 + macrophages']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}]","[{'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0251113', 'cui_str': 'CD163 antigen'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}]",,0.0901994,"During the Rg1 trial, acute increases of p16 INK4a+ cells in the muscle occurred immediately after exercise (+3-fold) and reversed near baseline 3 h later.","[{'ForeName': 'Jinfu', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Laboratory of Regenerative Medicine in Sports Science, School of Physical Education and Sports Science, South China Normal University, Guangzhou, China.'}, {'ForeName': 'I-Shiung', 'Initials': 'IS', 'LastName': 'Cheng', 'Affiliation': 'Laboratory of Exercise Nutrition, National Taichung University of Education, Taichung, Taiwan.'}, {'ForeName': 'Suchada', 'Initials': 'S', 'LastName': 'Saovieng', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Wei-Horng', 'Initials': 'WH', 'LastName': 'Jean', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Chung-Lan', 'Initials': 'CL', 'LastName': 'Kao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital and National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yung-Yang', 'Initials': 'YY', 'LastName': 'Liu', 'Affiliation': 'Department of Chest Medicine, Taipei Veterans General Hospital and National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Yang', 'Initials': 'CY', 'LastName': 'Huang', 'Affiliation': 'Chinese Medicine, Hualien Tzu Chi Hospital, Tzu Chi Medical Foundation, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Tania Xu Yar', 'Initials': 'TXY', 'LastName': 'Lee', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Ivy', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, TX 78712, USA.'}, {'ForeName': 'Chia-Hua', 'Initials': 'CH', 'LastName': 'Kuo', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei, Taiwan.'}]",Aging,['10.18632/aging.103763']
1490,33112363,Effectiveness of Home-Based Mobile Guided Cardiac Rehabilitation as Alternative Strategy for Nonparticipation in Clinic-Based Cardiac Rehabilitation Among Elderly Patients in Europe: A Randomized Clinical Trial.,"Importance
Although nonparticipation in cardiac rehabilitation is known to increase cardiovascular mortality and hospital readmissions, more than half of patients with coronary artery disease in Europe are not participating in cardiac rehabilitation.
Objective
To assess whether a 6-month guided mobile cardiac rehabilitation (MCR) program is an effective therapy for elderly patients who decline participation in cardiac rehabilitation.
Design, Setting, and Participants
Patients were enrolled in this parallel multicenter randomized clinical trial from November 11, 2015, to January 3, 2018, and follow-up was completed on January 17, 2019, in a secondary care system with 6 cardiac institutions across 5 European countries. Researchers assessing primary outcome were masked for group assignment. A total of 4236 patients were identified with a recent diagnosis of acute coronary syndrome, coronary revascularization, or surgical or percutaneous treatment for valvular disease, or documented coronary artery disease, of whom 996 declined to start cardiac rehabilitation. Subsequently, 179 patients who met the inclusion and exclusion criteria consented to participate in the European Study on Effectiveness and Sustainability of Current Cardiac Rehabilitation Programmes in the Elderly trial. Data were analyzed from January 21 to October 11, 2019.
Interventions
Six months of home-based cardiac rehabilitation with telemonitoring and coaching based on motivational interviewing was used to stimulate patients to reach exercise goals. Control patients did not receive any form of cardiac rehabilitation throughout the study period.
Main Outcomes and Measures
The primary outcome parameter was peak oxygen uptake (Vo2peak) after 6 months.
Results
Among 179 patients randomized (145 male [81%]; median age, 72 [range, 65-87] years), 159 (89%) were eligible for primary end point analysis. Follow-up at 1 year was completed for 151 patients (84%). Peak oxygen uptake improved in the MCR group (n = 89) at 6 and 12 months (1.6 [95% CI, 0.9-2.4] mL/kg-1/min-1 and 1.2 [95% CI, 0.4-2.0] mL/kg-1/min-1, respectively), whereas there was no improvement in the control group (n = 90) (+0.2 [95% CI, -0.4 to 0.8] mL/kg-1/min-1 and +0.1 [95% CI, -0.5 to 0.7] mL/kg-1/min-1, respectively). Changes in Vo2peak were greater in the MCR vs control groups at 6 months (+1.2 [95% CI, 0.2 to 2.1] mL/kg-1/min-1) and 12 months (+0.9 [95% CI, 0.05 to 1.8] mL/kg-1/min-1). The incidence of adverse events was low and did not differ between the MCR and control groups.
Conclusions and Relevance
These results suggest that a 6-month home-based MCR program for patients 65 years or older with coronary artery disease or a valvular intervention was safe and beneficial in improving Vo2peak when compared with no cardiac rehabilitation.
Trial Registration
trialregister.nl Identifier: NL5168.",2020,"Peak oxygen uptake improved in the MCR group (n = 89) at 6 and 12 months (1.6 [95% CI, 0.9-2.4] mL/kg-1/min-1 and 1.2 [95% CI, 0.4-2.0] mL/kg-1/min-1, respectively), whereas there was no improvement in the control group (n = 90) (+0.2 [95% CI, -0.4 to 0.8] mL/kg-1/min-1 and +0.1 [95% CI, -0.5 to 0.7] mL/kg-1/min-1, respectively).","['Participants\n\n\nPatients were enrolled in this parallel multicenter randomized clinical trial from November 11, 2015, to January 3, 2018, and follow-up was completed on January 17, 2019, in a secondary care system with 6 cardiac institutions across 5 European countries', 'patients 65 years or older with coronary artery disease or a', '179 patients who met the inclusion and exclusion criteria consented to participate in the European Study on Effectiveness and Sustainability of Current Cardiac Rehabilitation Programmes in the Elderly trial', 'patients with coronary artery disease in Europe', '179 patients randomized (145 male [81%]; median age, 72 [range, 65-87] years), 159 (89%) were eligible for primary end point analysis', 'Elderly Patients in Europe', 'elderly patients who decline participation in cardiac rehabilitation', '4236 patients were identified with a recent diagnosis of acute coronary syndrome, coronary revascularization, or surgical or percutaneous treatment for valvular disease, or documented coronary artery disease, of whom 996 declined to start cardiac rehabilitation']","['Home-Based Mobile Guided Cardiac Rehabilitation', 'valvular intervention', 'telemonitoring and coaching based on motivational interviewing', 'guided mobile cardiac rehabilitation (MCR) program']","['Changes in Vo2peak', 'Peak oxygen uptake', 'cardiovascular mortality and hospital readmissions', 'peak oxygen uptake (Vo2peak', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026265', 'cui_str': 'Mitral valve disorder'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",4236.0,0.13279,"Peak oxygen uptake improved in the MCR group (n = 89) at 6 and 12 months (1.6 [95% CI, 0.9-2.4] mL/kg-1/min-1 and 1.2 [95% CI, 0.4-2.0] mL/kg-1/min-1, respectively), whereas there was no improvement in the control group (n = 90) (+0.2 [95% CI, -0.4 to 0.8] mL/kg-1/min-1 and +0.1 [95% CI, -0.5 to 0.7] mL/kg-1/min-1, respectively).","[{'ForeName': 'Johan A', 'Initials': 'JA', 'LastName': 'Snoek', 'Affiliation': 'Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Eva I', 'Initials': 'EI', 'LastName': 'Prescott', 'Affiliation': 'Department of Cardiology, Bispebjerg Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Astrid E', 'Initials': 'AE', 'LastName': 'van der Velde', 'Affiliation': 'Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Thijs M H', 'Initials': 'TMH', 'LastName': 'Eijsvogels', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Nicolai', 'Initials': 'N', 'LastName': 'Mikkelsen', 'Affiliation': 'Department of Cardiology, Bispebjerg Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Leonie F', 'Initials': 'LF', 'LastName': 'Prins', 'Affiliation': 'Diagram, Zwolle, the Netherlands.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Bruins', 'Affiliation': ''}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Meindersma', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'González-Juanatey', 'Affiliation': 'Department of Cardiology, Hospital Clínico Universitario de Santiago, Instituto de Investigación Sanitaria, CIBER CV, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Peña-Gil', 'Affiliation': 'Department of Cardiology, Hospital Clínico Universitario de Santiago, Instituto de Investigación Sanitaria, CIBER CV, Madrid, Spain.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'González-Salvado', 'Affiliation': 'Department of Cardiology, Hospital Clínico Universitario de Santiago, Instituto de Investigación Sanitaria, CIBER CV, Madrid, Spain.'}, {'ForeName': 'Feriel', 'Initials': 'F', 'LastName': 'Moatemri', 'Affiliation': 'Department of Cardiac Rehabilitation, Assistance Publique Hopitaux de Paris, Paris, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Iliou', 'Affiliation': 'Department of Cardiac Rehabilitation, Assistance Publique Hopitaux de Paris, Paris, France.'}, {'ForeName': 'Thimo', 'Initials': 'T', 'LastName': 'Marcin', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Prisca', 'Initials': 'P', 'LastName': 'Eser', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Arnoud W J', 'Initials': 'AWJ', 'LastName': ""Van't Hof"", 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands.'}, {'ForeName': 'Ed P', 'Initials': 'EP', 'LastName': 'de Kluiver', 'Affiliation': 'Isala Heart Center, Zwolle, the Netherlands.'}]",JAMA cardiology,['10.1001/jamacardio.2020.5218']
1491,33113253,Effects of including sprints during prolonged cycling on hormonal and muscular responses and recovery in elite cyclists.,"This study investigated the acute effects of including 30-second sprints during prolonged low-intensity cycling on muscular and hormonal responses and recovery in elite cyclists. Twelve male cyclists (VO 2max , 73.4 ± 4.0 mL/kg/min) completed a randomized crossover protocol, wherein 4 hours of cycling at 50% of VO 2max were performed with and without inclusion of three sets of 3 × 30 seconds maximal sprints (E&S vs E, work-matched). Muscle biopsies (m. vastus lateralis) and blood were sampled at Pre, immediately after (Post) and 3 hours after (3 h) finalizing sessions. E&S led to greater increases in mRNA levels compared with E for markers of fat metabolism (PDK4, Δ-Log2 fold change between E&S and E ± 95%CI Post; 2.1 ± 0.9, Δ3h; 1.3 ± 0.7) and angiogenesis (VEGFA, Δ3h; 0.3 ± 0.3), and greater changes in markers of muscle protein turnover (myostatin, ΔPost; -1.4 ± 1.2, Δ3h; -1.3 ± 1.3; MuRF1, ΔPost; 1.5 ± 1.2, all P < .05). E&S showed decreased mRNA levels for markers of ion transport at 3h (Na + -K + α1; -0.6 ± 0.6, CLC1; -1.0 ± 0.8 and NHE1; -0.3 ± 0.2, all P < .05) and blunted responses for a marker of mitochondrial biogenesis (PGC-1α, Post; -0.3 ± 0.3, 3h; -0.4 ± 0.3, P < .05) compared with E E&S and E showed similar endocrine responses, with exceptions of GH and SHBG, where E&S displayed lower responses at Post (GH; -4.1 ± 3.2 μg/L, SHBG; -2.2 ± 1.9 nmol/L, P < .05). Both E&S and E demonstrated complete recovery in isokinetic knee extension torque 24 hours after exercise. In conclusion, we demonstrate E&S to be an effective exercise protocol for elite cyclists, which potentially leads to beneficial adaptations in skeletal muscle without impairing muscle recovery 24 hours after exercise.",2020,E&S showed decreased mRNA levels for markers of ion transport at 3h,"['Twelve male cyclists (VO 2max , 73.4±4.0 mL·kg -1 ·min -1 ', 'elite cyclists']",['30-s sprints during prolonged low intensity cycling'],"['mRNA-levels', 'mRNA levels', 'μg·L -1 , SHBG']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}]",12.0,0.0755787,E&S showed decreased mRNA levels for markers of ion transport at 3h,"[{'ForeName': 'Nicki Winfield', 'Initials': 'NW', 'LastName': 'Almquist', 'Affiliation': 'Institute of Public Health and Sport Sciences, Inland Norway University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Ellefsen', 'Affiliation': 'Institute of Public Health and Sport Sciences, Inland Norway University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Sandbakk', 'Affiliation': 'Center for Elite Sports Research, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Bent R', 'Initials': 'BR', 'LastName': 'Rønnestad', 'Affiliation': 'Institute of Public Health and Sport Sciences, Inland Norway University of Applied Sciences, Lillehammer, Norway.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13865']
1492,33115543,Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES
Primary Objective: To evaluate the efficacy and safety of oral administration of imatinib combined with the Best Conventional Care (BCC) versus placebo plus BCC in hospitalized patients with COVID-19.
HYPOTHESIS
Addition of imatinib to the BCC will provide a superior clinical outcome for patients with COVID-19 compared with BCC plus placebo. This hypothesis is on the basis of 1) intralysosomal entrapment of imatinib will increase endosomal pH and effectively decrease SARS-CoV-2/cell fusion, 2) kinase inhibitory activity of imatinib will interfere with budding/release or replication of SARS-CoV-2, and 3) because of the critical role of mechanical ventilation in the care of patients with ARDS, imatinib will have a significant clinical impact for patients with critical COVID-19 infection in Intensive Care Unit (ICU).
TRIAL DESIGN
This is an individual patient-level randomized, double-blind, placebo-controlled, two-parallel arm phase 3 study to evaluate the safety and efficacy of imatinib for the treatment of hospitalized adults with COVID-19. Participants will be followed for up to 60 days from the start of study drug administration. This trial will be conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonization.
PARTICIPANTS
Inclusion Criteria: Patients may be included in the study only if they meet all of the following criteria: 1) Ability to understand and willingness to sign a written informed consent document. Informed consent must be obtained prior to participation in the study. For patients who are too unwell to provide consent such as patients on invasive ventilator or extracorporeal membrane oxygenation (ECMO), their Legally Authorized Representative (LAR) can sign the informed consent, 2) Hospitalized patients ≥18 years of age, 3) Positive reverse transcriptase-polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or bronchoalveolar lavage (BAL)) by Center for Disease Control or local laboratory within 7 days of randomization, 4) Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study.
EXCLUSION CRITERIA
Patients meeting any of the following criteria are not eligible for the study: 1) Patients receiving any other investigational agents in a clinical trial. Off-label use of agents such as hydroxychloroquine is not an exclusion criterion, 2) Pregnant or breastfeeding women, 3) Patients with significant liver or renal dysfunction at the time of screening as defined as: 3.1) Direct bilirubin >2.5 mg/dL, 3.2) AST, ALT, or alkaline phosphatase >5x upper limit of normal, 3.3) eGFR ≤30 mL/min or requiring renal replacement therapy, 4) Patients with significant hematologic disorder at screen as defined as: 4.1) Absolute neutrophil count (ANC) <500/μL, 4.2) Platelet <20,000/μL, 4.3) Hemoglobin <7 g/dL, 5) Uncontrolled underlying illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled active seizure disorder, or psychiatric illness/social situations that per site Principal Investigator's judgment would limit compliance with study requirements, 6) Known allergy to imatinib or its component products, 7) Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study. Both men and women of all races and ethnic groups are eligible for this trial. University of Maryland Medical Center, Baltimore, MD is the initiating site. The study may be opened in other centers on the basis of the accrual rate or the magnitude of the COVID-19 pandemic.
INTERVENTION AND COMPARATOR
Imatinib: All doses of imatinib should be administered with a meal and a large glass of water. Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing. In this study, patients with confirmed positive COVID-19 tests receive imatinib for a total of 14 days; 400 mg orally daily Days 1-14. Imatinib 400 mg tablets will be encapsulated using size 000 capsules and cellulose microcrystalline filler. For patients on ventilator or ECMO, imatinib will be given as oral suspension (40 mg/mL). To make the oral suspension, imatinib tablets will be crushed and mixed in Ora-sweet solution to yield a concentration of 40 mg/mL suspension by pharmacy. Additionally, in the absence of supportive microbiological testing results, we confirm that the in-use stability period for the prepared imatinib suspensions will be 24 hours at room temperature or 7 days at refrigerated conditions. The pharmacy staff will follow the American Society Health-System Pharmacists (ASHP) guidelines for handling hazardous drugs. Placebo: The matching placebo will be packaged by Investigational Drug Service Pharmacy at University of Maryland Medical Center. The placebos will be prepared using size 000 capsules and cellulose microcrystalline filler. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Concomitant Medications/supportive care: In both arms, patients can receive concomitant available local standard of care antipyretics, antibacterials, antivirals, antifungals and anti-inflammatory including hydroxychloroquine at the discretion of the treating physician as necessary. For other drug-drug interactions particularly with CYP P450, the treating physician should consider the risk and benefit of drug administration based on available information. Co-administration of off-label immunomodulatory treatments for COVID-19 including but not limited to corticosteroids, sarilumab, clazakizumab, tocilizumab, and anakinra will be allowed but may affect interpretability of study outcomes. The timing, dosing, and duration of these treatments will be meticulously collected, including any of these treatments that may be used for participants who experience progression of COVID-19 disease after study enrollment. Two analyses will be performed, the primary analysis will compare the primary endpoint in the two trial arms irrespective of any other treatment; the second analysis will be stratified for co-administration of immunomodulatory drugs.
MAIN OUTCOMES
The primary endpoint is the proportion of patients with a two-point improvement at Day 14 from baseline using the 8-category ordinal scale. The ordinal scale is an evaluation of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. The secondary endpoints include: All-cause mortality at Day 28, All-cause mortality at Day 60, Time to a 2-point clinical improvement difference over baseline, Duration of hospitalization, Duration of ECMO or invasive mechanical ventilation (for subjects who are on ECMO or mechanical ventilation at Day 1), Duration of ICU stay (for subjects who are in ICU at Day 1), Time to SARS-CoV-2 negative by RT-PCR, Proportion of patients with negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by RT-PCR on days 5, 10, 14, 21, and 28 after starting treatment, Proportion of subjects with serious adverse events, Proportion of subjects who discontinue study drug due to adverse events. The exploratory endpoints include: Determine the impact of treatment arms on IL-6 levels, Obtain blood/peripheral blood mononuclear cells (PBMCs) for storage to look at transcriptomics in severe disease, Association of major histocompatibility complex (MHC) with severity of illness, Mean change in the ordinal scale from baseline, Time to an improvement of one category from admission using an ordinal scale, Duration of hospitalization, Duration of new oxygen use, Number of oxygenation free days, Duration of new mechanical ventilation, Number of ventilator free days.
RANDOMIZATION
Eligible patients will be uniformly randomized in 1:1 ratio to receive either imatinib or placebo for 14 days. Both groups will receive the BCC. The randomized treatment allocations use stratified, permuted block randomization with a variable block size; blocks are generated using a validated random number generator. In order to balance the severity of the respiratory illness between the two arms, randomization will be stratified based on radiographic findings and oxygen requirements: 1) Severe disease: evidence of pneumonia on chest X-ray or CT scan OR chest auscultation (rales, crackles), and SpO 2 ≤92% on ambient air or PaO 2 /FiO 2 <300 mmHg, and requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device; 2) Critical disease: requires supplemental oxygen delivered by non-rebreather mask or high flow cannula OR use of invasive or non-invasive ventilation OR requiring treatment in an intensive care unit, use of vasopressors, extracorporeal life support, or renal replacement therapy.
BLINDING (MASKING)
The participants, caregivers, and the statistician are blinded to group assignment. The only people who are not blinded are Site Pharmacists. Blinding will be performed via a specific randomization process. Centralized, concealed randomization will be executed by the Primary Site's Pharmacist. Data on eligible consented cases will be submitted electronically on the appropriate on-study form to the pharmacy, where the patient is randomized to imatinib or placebo. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)
The trial is designed as a double-blind, two-parallel arm, randomized controlled trial with a uniform (1:1) allocation ratio to: Arm A) Imatinib or Arm B) Placebo. Patients in both arms will receive the BCC per local institutional standards at the discretion of the treating physician. Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20. The proportion in Arm A (imatinib treatment arm) is assumed to be 0.30 under the null hypothesis and 0.50 under the alternative hypothesis. The proportion in Arm B (placebo control arm) is 0.30. The test statistic used is the two-sided Fisher's Exact Test. The significance level of the test is targeted at 0.05. The significance level actually achieved by this design is α=0.0385. The power of the test is calculated using binomial enumeration of all possible outcomes. The primary analysis will be conducted using an intention to treat principle (ITT) for participants who at least receive one dose of study drug or placebo. The sample size is not inflated for dropouts. All patients will be evaluable irrespective of the clinical course of their disease.
TRIAL STATUS
Current protocol version is 1.2 from May 8, 2020. The recruitment started on June 15, 2020 and is ongoing. We originally anticipated that the trial would finish recruitment by mid 2021. We are aware of the enrollment requirement of approximately 200 patients, which is required to provide scientific integrity of the results. We are also aware of the fact that enrolling this number of patients in a single-site at University of Maryland Medical Center (UMMC) may take longer than expected, particularly taken into account other competing studies. For this reason, we are actively considering opening the protocol in other sites. After identification of other sites, we will fulfill all regulatory requirements before opening the protocol in other sites.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04394416 . First Posted: May 19, 2020; Last Update Posted: June 4, 2020. FDA has issued the ""Study May Proceed"" Letter for this clinical trial under the Investigational New Drug (IND) number 149239.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20.,"['Inclusion Criteria', 'patients who are too unwell to provide consent such as patients on invasive ventilator or extracorporeal membrane oxygenation (ECMO), their Legally Authorized Representative (LAR) can sign the informed consent, 2) Hospitalized patients ≥18 years of age, 3) Positive reverse transcriptase-polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or bronchoalveolar lavage (BAL)) by Center for Disease Control or local laboratory within 7 days of randomization, 4', 'Patients meeting any of the following criteria are not eligible for the study: 1) Patients receiving any other investigational agents in a clinical trial', 'hospitalized adults with COVID-19', 'hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death', 'patients having difficulty swallowing', 'participants who experience progression of COVID-19 disease after study enrollment', 'patients with COVID-19 compared with BCC plus', 'Hospitalized Adults with COVID-19', '4) Patients with significant hematologic disorder at screen as defined as: 4.1) Absolute neutrophil count (ANC) <500/μL, 4.2', 'hospitalized patients with COVID-19', 'Pregnant or breastfeeding women, 3) Patients with significant liver or renal dysfunction at the time of screening as defined as: 3.1', 'patients with critical COVID-19 infection in Intensive Care Unit (ICU']","['Concomitant Medications/supportive care', 'hydroxychloroquine', 'supplemental oxygen delivered by non-rebreather mask or high flow cannula OR use of invasive or non-invasive ventilation OR requiring treatment in an intensive care unit, use of vasopressors, extracorporeal life support, or renal replacement therapy', 'imatinib or placebo', 'placebo plus BCC', 'ECMO, placebo', 'imatinib combined with the Best Conventional Care (BCC', 'Imatinib 400 mg capsules and placebo', 'Imatinib', 'Imatinib or Arm B) Placebo', 'Imatinib 400', 'placebo', 'imatinib', 'Direct bilirubin', 'Placebo', 'placebos', 'Co']","['8-category ordinal scale', 'Safety and Efficacy', 'efficacy and safety', 'safety and efficacy', 'proportion of patients with a two-point improvement', 'IL-6 levels, Obtain blood/peripheral blood mononuclear cells (PBMCs) for storage to look at transcriptomics in severe disease, Association of major histocompatibility complex (MHC) with severity of illness, Mean change in the ordinal scale from baseline, Time to an improvement of one category from admission using an ordinal scale, Duration of hospitalization, Duration of new oxygen use, Number of oxygenation free days, Duration of new mechanical ventilation, Number of ventilator free days', ' All-cause mortality at Day 28, All-cause mortality at Day 60, Time to a 2-point clinical improvement difference over baseline, Duration of hospitalization, Duration of ECMO or invasive mechanical ventilation (for subjects who are on ECMO or mechanical ventilation at Day 1), Duration of ICU stay']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0857256', 'cui_str': 'Unwell'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C1535502', 'cui_str': 'Bronchoalveolar lavage'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0421203', 'cui_str': 'Home oxygen supply'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1960093', 'cui_str': 'Nonrebreather oxygen mask'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1331284', 'cui_str': 'imatinib 400 MG'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0201916', 'cui_str': 'Bilirubin, direct measurement'}]","[{'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0024518', 'cui_str': 'Major histocompatibility complex'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",1.0,0.286981,Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20.,"[{'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Emadi', 'Affiliation': 'University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, 22 South Greene Street, Room N9E06, Baltimore, Maryland, 21201, USA. aemadi@umm.edu.'}, {'ForeName': 'Joel V', 'Initials': 'JV', 'LastName': 'Chua', 'Affiliation': 'University of Maryland School of Medicine Department of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Talwani', 'Affiliation': 'University of Maryland School of Medicine Department of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Søren M', 'Initials': 'SM', 'LastName': 'Bentzen', 'Affiliation': 'University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, 22 South Greene Street, Room N9E06, Baltimore, Maryland, 21201, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Baddley', 'Affiliation': 'University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, 22 South Greene Street, Room N9E06, Baltimore, Maryland, 21201, USA.'}]",Trials,['10.1186/s13063-020-04819-9']
1493,33124789,"Effect of core training on speed, quickness and agility in young male football players.","BACKGROUND
Core training effectively improves sport performance. The purpose of this study was to determine the effect of core training on the performance measures of speed, agility and quickness of U19 male football players.
METHODS
A total of 24 young male football players were divided into 12 in the experimental group (aged 18.17±0.72) and 12 in the control group (aged 18.31±0.75). The experimental group performed 30-35 min core training three days a week for eight weeks while the control group continued their routine training. Measurements included a 40-meter sprint test for speed, a hexagon test for quickness and an agility-T test for agility. Pre-test measurements at the start of the study and post-test measurements after eight weeks were compared by an ANOVA 2×2. A significant level of P<0.05 was established.
RESULTS
In the experimental group, there were an improvement in quickness (pre: 17.27±3.24""; post: 16.79±3.09""; P=0.005, η2=0.53) and agility (pre: 12.86±1.17""; post: 12.38±1.12""; P=0.003, η2=0.56), but the speed did not change (pre: 6.14±0.57""; post: 6.00±0.45"", P=0.653).
CONCLUSIONS
The use of core training in combination with normal football training is shown to be effective in improving quickness and agility but not speed among young male football players after a period of eight weeks. So, it appears reasonable to include specific core training programs within football training.",2020,"In the experimental group, there were an improvement in quickness (pre: 17.27±3.24""; post: 16.79±3.09""; P=0.005, η2=0.53) and agility (pre: 12.86±1.17""; post: 12.38±1.12""; P=0.003, η2=0.56), but the speed did not change (pre: 6.14±0.57""; post: 6.00±0.45"", P=0.653).
","['young male football players', '24 young male football players were divided into 12 in the experimental group (aged 18.17±0.72) and 12 in the control group (aged 18.31±0.75', 'U19 male football players']","['core training in combination with normal football training', 'core training', 'control group continued their routine training']","['speed, quickness and agility', 'sport performance', '40-meter sprint test for speed, a hexagon test for quickness and an agility-T test for agility. Pre-test measurements']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",24.0,0.0408926,"In the experimental group, there were an improvement in quickness (pre: 17.27±3.24""; post: 16.79±3.09""; P=0.005, η2=0.53) and agility (pre: 12.86±1.17""; post: 12.38±1.12""; P=0.003, η2=0.56), but the speed did not change (pre: 6.14±0.57""; post: 6.00±0.45"", P=0.653).
","[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Doğanay', 'Affiliation': 'Department of Sport Performance and Condition, Kocaeli University, Kocaeli, Turkey - muratdoganay41@gmail.com.'}, {'ForeName': 'Bergün M', 'Initials': 'BM', 'LastName': 'Bingül', 'Affiliation': 'Department of Sport Performance and Condition, Kocaeli University, Kocaeli, Turkey.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Álvarez-García', 'Affiliation': 'Department of Nursing, University of Jaén, Jaén, Spain.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10999-X']
1494,33124791,"Effects of exercise training and statin on hemodynamic, biochemical, inflammatory and immune profile of people living with HIV: a randomized, double-blind, placebo-controlled trial.","BACKGROUND
The aim of this study is to evaluate the effect of exercise training (ET) and statins on the hemodynamic, biochemical, inflammatory and immune profile of people living with HIV (PLHIV).
METHODS
This was a randomized, double-blind, placebo-controlled clinical trial in which 83 PLHIV were assigned to either placebo (PL), statins (STA), placebo + ET (PLET), or statins + ET (STAET) groups. Volunteers assigned to STA and STAET groups were administered 10 mg of rosuvastatin, whereas the PL and PLET groups were administered a placebo. The PLET and STAET groups performed ET three times a week. Before and after the 12-week follow-up, volunteers underwent blood collection to assess the biochemical, inflammatory, and immune profile.
RESULTS
There were significant time x group interaction effects (P<0.05) for all variables except for diastolic blood pressure. The PLET and STAET groups had significantly (P<0.05) decreased systolic blood pressure, resting heart rate, fasting glucose, glycated hemoglobin, fasting insulin, homeostatic model assessment for insulin resistance, creatine kinase, lactate, and TNF-α levels, and increased adiponectin, CD4+, and CD8+ levels. There was also a significant group effect (P<0.05) for CK levels among the exercised (PLET and STAET) and STA groups. The latter had a significant increase in fasting glucose (P<0.05) and creatine kinase (P<0.05).
CONCLUSIONS
ET improved the hemodynamic, biochemical, inflammatory, and immune profile of PLHIV and this effect was not dependent on the use of statins.",2020,There were significant time x group interaction effects (P<0.05) for all variables except for diastolic blood pressure.,"['people living with HIV (PLHIV', 'people living with HIV', '83 PLHIV']","['exercise training (ET) and statins', 'STA', 'placebo (PL), statins (STA), placebo + ET (PLET), or statins + ET (STAET', 'rosuvastatin', 'placebo', 'exercise training and statin']","['CK levels', 'hemodynamic, biochemical, inflammatory and immune profile', 'systolic blood pressure, resting heart rate, fasting glucose, glycated hemoglobin, fasting insulin, homeostatic model assessment for insulin resistance, creatine kinase, lactate, and TNF-α levels, and increased adiponectin, CD4+, and CD8+ levels', 'hemodynamic, biochemical, inflammatory, and immune profile of PLHIV', 'fasting glucose (P<0.05) and creatine kinase (P<0.05', 'diastolic blood pressure']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",83.0,0.327068,There were significant time x group interaction effects (P<0.05) for all variables except for diastolic blood pressure.,"[{'ForeName': 'Hugo R', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'IMEPAC University Center, Araguari, Brazil - hugo.zanetti@hotmail.com.'}, {'ForeName': 'Edmar L', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Federal University of Triângulo Mineiro, Uberaba, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'IMEPAC University Center, Araguari, Brazil.'}, {'ForeName': 'Leandro T', 'Initials': 'LT', 'LastName': 'Lopes', 'Affiliation': 'Brazil University, Fernandópolis, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Mário L', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Federal University of Triângulo Mineiro, Uberaba, Brazil.'}, {'ForeName': 'Fernando F', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Federal University of Triângulo Mineiro, Uberaba, Brazil.'}, {'ForeName': 'Elmiro S', 'Initials': 'ES', 'LastName': 'Resende', 'Affiliation': 'Federal University of Uberlândia, Uberlândia, Brazil.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10838-7']
1495,33124792,Different types of functional training on the functionality and quality of life in postmenopausal women: a randomized and controlled trial.,"BACKGROUND
Physical exercise is widely recommended for improving physical fitness. However, the most effective training method in improving the daily life of postmenopausal women is not clear. Therefore, this study compares different ways of functional training, focused on the task, and directed to the physical abilities on the functionality and quality of life of the postmenopausal women.
METHODS
Forty-seven participants were randomly assigned into three groups: element-based functional training (EBFT); task-specific-based functional training (TSBFT); and the control group (CG). The intervention lasted fourteen weeks, with three weekly sessions stimulating several physical valences in the same session. The global functionality, functional reach, gait speed, handgrip strength, jumping ability, and quality of life before and after the intervention were evaluated.
RESULTS
A similar increase was detected in both experimental groups for the variables-analyzed when compared to the initial moment (P<0.05), except in the dynamic postural control (P>0.05), which showed no difference. However, in the tests of rising from the floor and handgrip strength, only the task-specific-based functional training showed difference over time (P<0.05).
CONCLUSIONS
Functional training protocols improve the performance in daily activities of postmenopausal women. However, task-specific-based functional training is more effective when compared to the control group in the analyzed variables.",2020,"The global functionality, functional reach, gait speed, handgrip strength, jumping ability, and quality of life before and after the intervention were evaluated.
","['Forty-seven participants', 'postmenopausal women']","['Physical exercise', 'functional training', 'element-based functional training (EBFT); task-specific-based functional training (TSBFT); and the control group (CG', 'Functional training protocols']","['functionality and quality of life', 'global functionality, functional reach, gait speed, handgrip strength, jumping ability, and quality of life']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",47.0,0.02356,"The global functionality, functional reach, gait speed, handgrip strength, jumping ability, and quality of life before and after the intervention were evaluated.
","[{'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Aragão-Santos', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe, São Cristóvão, Brazil - carlosaragao.18@gmail.com.'}, {'ForeName': 'Antônio G', 'Initials': 'AG', 'LastName': 'de Resende-Neto', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe, São Cristóvão, Brazil.'}, {'ForeName': 'Marzo E', 'Initials': 'ME', 'LastName': 'Da Silva-Grigoletto', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe, São Cristóvão, Brazil.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10995-2']
1496,33119572,Exploring Pasifika wellbeing: findings from a large cluster randomised controlled trial of a mobile health intervention programme.,"AIM
The primary objective of this study was to determine the effect of a mobile health (mHealth) intervention on the wellbeing of Pasifika peoples, and to explore factors associated with Pasifika wellbeing.
METHODS
The OL@-OR@ mHealth programme was a co-designed smartphone app. Culturally relevant data was collected to examine holistic health and wellbeing status, at baseline, and at 12 weeks (end of the trial). The concept of wellbeing was examined as part of a two-arm, cluster randomised trial, using only the Pasifika data: 389 (of 726) Pasifika adults were randomised to receive the mHealth intervention, while 405 (of 725) Pasifika adults were randomised to receive a control version of the intervention. Culturally relevant data was collected to examine holistic health and wellbeing status, at baseline, and at 12 weeks (end of the trial). The intervention effects and the association of demographic and behavioural relationships with wellbeing, was examined using logistic regression analyses.
RESULTS
Relative to baseline, there were significant differences between the intervention and control groups for the 'family/community' wellbeing, at the end of the 12-week trial. There were no significant differences observed for all other wellbeing domains for both groups. Based on our multivariate regression analyses, education and acculturation (assimilation and marginalisation) were identified as positively strong factors associated to Pasifika 'family and community' wellbeing.
CONCLUSION
Our study provides new insights on how Pasifika peoples' characteristics and behaviours align to wellbeing. Our findings point to 'family and community' as being the most important wellbeing factor for Pasifika peoples.",2020,"RESULTS
Relative to baseline, there were significant differences between the intervention and control groups for the 'family/community' wellbeing, at the end of the 12-week trial.",['Pasifika adults'],"['mobile health (mHealth) intervention', 'mobile health intervention programme', 'mHealth intervention']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0707487,"RESULTS
Relative to baseline, there were significant differences between the intervention and control groups for the 'family/community' wellbeing, at the end of the 12-week trial.","[{'ForeName': 'Ridvan', 'Initials': 'R', 'LastName': 'Firestone', 'Affiliation': 'Senior Research Officer/Co-Principal Investigator, Centre for Public Health Research, Massey University, Wellington.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Biostatistician, Centre for Public Health Research, Massey University, Wellington.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Dalhousie', 'Affiliation': 'Community Partner, The Fono, Auckland.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hughes', 'Affiliation': 'Community Coordinator, The Fono, Auckland.'}, {'ForeName': 'Tevita', 'Initials': 'T', 'LastName': 'Funaki', 'Affiliation': 'Chief Executive, Community Partner, The Fono, Auckland.'}, {'ForeName': 'Akarere', 'Initials': 'A', 'LastName': 'Henry', 'Affiliation': 'Chief Executive, Community Partner, South Waikato Pacific Islands Community Services, Tokoroa.'}, {'ForeName': 'Mereaumate', 'Initials': 'M', 'LastName': 'Vano', 'Affiliation': 'Community Coordinator, South Waikato Pacific Islands Community Services, Tokoroa.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Grey', 'Affiliation': 'Project Manager, National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland.'}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Schumacher', 'Affiliation': 'Project Coordinator, National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jull', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland; School of Nursing, University of Auckland, Auckland.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Whittaker', 'Affiliation': 'Associate Professor, School of Nursing, University of Auckland, Auckland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Te Morenga', 'Affiliation': 'Senior Lecturer/Co-Principal Investigator, School of Health, Faculty of Health, Victoria University of Wellington, Wellington.'}, {'ForeName': 'Cliona Ni', 'Initials': 'CN', 'LastName': 'Mhurchu', 'Affiliation': 'Professor/Co-Principal Investigator, National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland.'}]",The New Zealand medical journal,[]
1497,33119613,"Effect of disease duration in a randomized Phase III trial of rintatolimod, an immune modulator for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.","BACKGROUND
Rintatolimod is a selective TLR3 agonist, which has demonstrated clinical activity for ME/CFS in Phase II and Phase III double-blind, placebo-controlled, randomized, multi-site clinical trials.
METHODS AND FINDINGS
A hypothesis-based post-hoc analysis of the Intent to Treat (ITT) population diagnosed with ME/CFS from 12 independent clinical sites of a Phase III trial was performed to evaluate the effect of rintatolimod therapy based on disease duration. The clinical activity of rintatolimod was evaluated by exercise treadmill tolerance (ETT) using a modified Bruce protocol. The ITT population (n = 208) was divided into two subsets of symptom duration. Patients with symptom duration of 2-8 years were identified as the Target Subset (n = 75); the remainder (<2 year plus >8 year) were identified as the Non-Target Subset (n = 133). Placebo-adjusted percentage improvements in exercise duration and the vertical rise for the Target Subset (n = 75) were more than twice that of the ITT population. The Non-Target Subset (n = 133) failed to show any clinically significant ETT response to rintatolimod when compared to placebo. Within the Target Subset, 51.2% of rintatolimod-treated patients improved their exercise duration by ≥25% (p = 0.003) despite reduced statistical power from division of the original ITT population into two subsets.
CONCLUSION/SIGNIFICANCE
Analysis of ETT from a Phase III trial has identified within the ITT population, a subset of ME/CFS patients with ≥2 fold increased exercise response to rintatolimod. Substantial improvement in physical performance was seen for the majority (51.2%) of these severely debilitated patients who improved exercise duration by ≥25%. This magnitude of exercise improvement was associated with clinically significant enhancements in quality of life. The data indicate that ME/CFS patients have a relatively short disease duration window (<8 years) to expect a significant response to rintatolimod under the dosing conditions utilized in this Phase III clinical trial. These results may have direct relevance to the cognitive impairment and fatigue being experienced by patients clinically recovered from COVID-19 and free of detectable SARS-CoV-2.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT00215800.",2020,Substantial improvement in physical performance was seen for the majority (51.2%) of these severely debilitated patients who improved exercise duration by ≥25%.,"['A hypothesis-based post-hoc analysis of the Intent to Treat (ITT) population diagnosed with ME/CFS from 12 independent clinical sites of a Phase III trial', 'Myalgic Encephalomyelitis/Chronic Fatigue Syndrome', 'Patients with symptom duration of 2-8 years were identified as the Target Subset (n = 75); the remainder (<2 year plus >8 year) were identified as the Non-Target Subset (n = 133']","['rintatolimod therapy', 'rintatolimod', 'placebo', 'Placebo']","['exercise duration', 'exercise duration and the vertical rise', 'quality of life', 'physical performance']","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517563', 'cui_str': '133'}]","[{'cui': 'C1434913', 'cui_str': 'rintatolimod'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",75.0,0.0896146,Substantial improvement in physical performance was seen for the majority (51.2%) of these severely debilitated patients who improved exercise duration by ≥25%.,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strayer', 'Affiliation': 'AIM ImmunoTech Inc., Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Young', 'Affiliation': 'AIM ImmunoTech Inc., Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Mitchell', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, Tennessee, United States of America.'}]",PloS one,['10.1371/journal.pone.0240403']
1498,33119658,"An exercise-based educational and motivational intervention after surgery can improve behaviors, physical fitness and quality of life in bariatric patients.","INTRODUCTION
Unhealthy lifestyles may hinder bariatric surgery outcomes. This non-randomized controlled study aimed to evaluate the effects of an integrated post-operative exercise-based educational and motivational program in improving behaviors, quality of life, anthropometric features, cardiorespiratory and physical fitness in bariatric patients respect to the only surgical intervention.
METHODS
A group of adult sedentary bariatric patients chose to attend a 12-month exercise program integrated with diet education and motivational support, or to receive usual care. Dietary habits, binge eating disorder, physical activity, obesity-related quality of life, Body Mass Index, waist and hip circumference, VO2max, strength and flexibility were assessed at the start and at the end of the study in both groups.
RESULTS
On a total of 82 patients enrolled, follow-up measures were obtained from 28 (85.7% females, mean age 38.2±8.7) and 42 (71.4% females, mean age 40.2±9.5) patients included in the intervention and control group, respectively. All the behavioral and physical outcomes improved significantly in the participants to the intervention, while the control group showed lesser changes, especially regarding quality of life and physical fitness.
CONCLUSIONS
Notwithstanding the self-selection, these results suggest that a timely postoperative behavioral multidisciplinary program for bariatric patients may be effective in establishing healthy behaviors which can lead to better surgery outcomes.",2020,"All the behavioral and physical outcomes improved significantly in the participants to the intervention, while the control group showed lesser changes, especially regarding quality of life and physical fitness.
","['82 patients enrolled, follow-up measures were obtained from 28 (85.7% females, mean age 38.2±8.7) and 42 (71.4% females, mean age 40.2±9.5', 'bariatric patients', 'bariatric patients respect to the only surgical intervention', 'A group of adult sedentary bariatric patients']","['exercise-based educational and motivational intervention', 'exercise program integrated with diet education and motivational support, or to receive usual care', 'integrated post-operative exercise-based educational and motivational program']","['Dietary habits, binge eating disorder, physical activity, obesity-related quality of life, Body Mass Index, waist and hip circumference, VO2max, strength and flexibility', 'behavioral and physical outcomes', 'quality of life and physical fitness', 'behaviors, quality of life, anthropometric features, cardiorespiratory and physical fitness', 'behaviors, physical fitness and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",82.0,0.0258224,"All the behavioral and physical outcomes improved significantly in the participants to the intervention, while the control group showed lesser changes, especially regarding quality of life and physical fitness.
","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gallé', 'Affiliation': 'Department of Movement Sciences and Wellbeing, University of Naples ""Parthenope"", Naples, Italy.'}, {'ForeName': 'Gianpaolo', 'Initials': 'G', 'LastName': 'Marte', 'Affiliation': 'Evangelical Hospital ""Villa Betania"", Naples, Italy.'}, {'ForeName': 'Assunta', 'Initials': 'A', 'LastName': 'Cirella', 'Affiliation': 'Department of Movement Sciences and Wellbeing, University of Naples ""Parthenope"", Naples, Italy.'}, {'ForeName': 'Mirella', 'Initials': 'M', 'LastName': 'Di Dio', 'Affiliation': 'Department of Movement Sciences and Wellbeing, University of Naples ""Parthenope"", Naples, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Miele', 'Affiliation': 'Department of Movement Sciences and Wellbeing, University of Naples ""Parthenope"", Naples, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Ricchiuti', 'Affiliation': 'Department of Movement Sciences and Wellbeing, University of Naples ""Parthenope"", Naples, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Liguori', 'Affiliation': 'Department of Movement Sciences and Wellbeing, University of Naples ""Parthenope"", Naples, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Maida', 'Affiliation': 'Evangelical Hospital ""Villa Betania"", Naples, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Liguori', 'Affiliation': 'Department of Movement Sciences and Wellbeing, University of Naples ""Parthenope"", Naples, Italy.'}]",PloS one,['10.1371/journal.pone.0241336']
1499,33120207,Longitudinal interrelationships of mental health discrimination and stigma with housing and well-being outcomes in adults with mental illness and recent experience of homelessness.,"RATIONALE
Stigma and discrimination are negatively associated with social and health status. People who are homeless often experience systemic stigma and discrimination.
OBJECTIVE
In this study, we analyze the longitudinal interrelationships between the trajectories of housing (housing stability) and well-being outcomes (i.e., recovery, quality of life, and community functioning) and the trajectories of discrimination and stigma in a sample of adults with mental illness and recent experiences of homelessness in Toronto, Canada. We also examined the effect of the Housing First (HF) intervention on these interrelationships.
METHOD
The Group-Based Trajectory Model was used to estimate the interrelationship (or intersections) between discrimination and stigma with housing stability, recovery, quality of life, and community functioning in 274 participants of the At Home/Chez Soi, phase 2, Toronto site randomized trial over a two-year follow-up period.
RESULTS
Three distinct trajectory groups were observed for discrimination (Low,Moderate decrease, and moderate increase), stigma (Low, Moderate, and High), recovery (Low, Moderate, and High), and the quality of life (Low, Moderate, and High). Two-trajectory groups (Low and High) were identified for housing stability and community functioning. The analyses showed that the trajectory groups for discrimination and stigma are strongly and contemporaneously interrelated with thetrajectory groups for housing stability, recovery, quality of life, and community functioning ability. The HF intervention had a mitigating effect on the changes across select trajectory groups, particularly for members of the Low and High discrimination and stigma trajectories group.
CONCLUSION
Persistent mental health-related discrimination and stigma trajectories are longitudinally and contemporaneously interrelated with housing and well-being outcomes in persons experiencing mental illness and recent homelessness. These findings indicate the need for interventions and actions to reduce stigma toward thispopulation. Such interventions may improve housing stability, quality of life, mental health recovery, and community functioning.",2020,"The analyses showed that the trajectory groups for discrimination and stigma are strongly and contemporaneously interrelated with thetrajectory groups for housing stability, recovery, quality of life, and community functioning ability.","['274 participants of the At Home/Chez Soi, phase 2, Toronto site randomized trial over a two-year follow-up period', 'adults with mental illness and recent experiences of homelessness in Toronto, Canada', 'adults with mental illness and recent experience of homelessness', 'persons experiencing mental illness and recent homelessness', 'People who are homeless often experience systemic stigma and discrimination']","['Housing First (HF) intervention', 'HF intervention']","['trajectories of housing (housing stability) and well-being outcomes (i.e., recovery, quality of life, and community functioning) and the trajectories of discrimination and stigma', 'housing stability, recovery, quality of life, and community functioning ability', 'discrimination (Low,Moderate decrease, and moderate increase), stigma (Low, Moderate, and High), recovery (Low, Moderate, and High), and the quality of life (Low, Moderate, and High', 'housing stability, quality of life, mental health recovery, and community functioning']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0676803', 'cui_str': 'Styrene-oxide isomerase'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4505046', 'cui_str': 'Mental Health Recovery'}]",274.0,0.0382565,"The analyses showed that the trajectory groups for discrimination and stigma are strongly and contemporaneously interrelated with thetrajectory groups for housing stability, recovery, quality of life, and community functioning ability.","[{'ForeName': 'Cilia', 'Initials': 'C', 'LastName': 'Mejia-Lancheros', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada. Electronic address: Cilia.Mejia-Lancheros@unityhealth.to.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lachaud', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Woodhall-Melnik', 'Affiliation': 'Department of Social Sciences, Faculty of Arts, University of New Brunswick, Saint John, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': ""O'Campo"", 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Hwang', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada; Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Stergiopoulos', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.""}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113463']
1500,33120238,Classification of renal tumour using convolutional neural networks to detect oncocytoma.,"PURPOSE
To investigate the ability of convolutional neural networks (CNNs) to facilitate differentiation of oncocytoma from renal cell carcinoma (RCC) using non-invasive imaging technology.
METHODS
Data were collected from 369 patients between January 2015 and September 2018. True labelling of scans as benign or malignant was determined by subsequent histological findings post-surgery or ultrasound-guided percutaneous biopsy. The data included 20,000 2D CT images. Data were randomly divided into sets for training (70 %), validation (10 %) and independent testing (20 %, DataTest_1). A small dataset (DataTest_2) was used for additional validation of the training model. Data were divided into sets at the patient level, rather than by individual image. A modified version of the ResNet50V2 was used. Accuracy of detecting benign or malignant renal mass was evaluated by a 51 % majority vote of individual image classifications to determine the classification for each patient.
RESULTS
Test results from DataTest_1 indicate an area under the curve (AUC) of 0.973 with 93.3 % accuracy and 93.5 % specificity. Results from DataTest_2 indicate an AUC of 0.946 with 90.0 % accuracy and 98.0 % specificity when evaluation is performed image by image. There is no case in which multiple false negative images originate from the same patient. When evaluated with 51 % majority of scans for each patient, the accuracy rises to 100 % and the incidence of false negatives falls to zero.
CONCLUSION
CNNs and deep learning technology can classify renal tumour masses as oncocytoma with high accuracy. This diagnostic method could prevent overtreatment for patients with renal masses.",2020,True labelling of scans as benign or malignant was determined by subsequent histological findings post-surgery or ultrasound-guided percutaneous biopsy.,"['Data were collected from 369 patients between January 2015 and September 2018', 'patients with renal masses']","['convolutional neural networks (CNNs', 'CNNs and deep learning technology']","['Accuracy of detecting benign or malignant renal mass', 'accuracy rises', 'area under the curve (AUC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262613', 'cui_str': 'Renal mass'}]","[{'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0262613', 'cui_str': 'Renal mass'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",369.0,0.020162,True labelling of scans as benign or malignant was determined by subsequent histological findings post-surgery or ultrasound-guided percutaneous biopsy.,"[{'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Pedersen', 'Affiliation': 'Department of People and Technology (DPT), Roskilde University Universitetsvej 1, 4000, Roskilde, Denmark. Electronic address: mikkped@ruc.dk.'}, {'ForeName': 'Michael Brun', 'Initials': 'MB', 'LastName': 'Andersen', 'Affiliation': 'Department of Radiology, Herlev-Gentofte University Hospital, Herlev Ringvej 75, 2700, Herlev, Denmark. Electronic address: michael.brun.andersen@regionh.dk.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Christiansen', 'Affiliation': 'Department of People and Technology (DPT), Roskilde University Universitetsvej 1, 4000, Roskilde, Denmark. Electronic address: henning@ruc.dk.'}, {'ForeName': 'Nessn H', 'Initials': 'NH', 'LastName': 'Azawi', 'Affiliation': 'Department of Urology, Zealand University Hospital, Roskilde, Department of Clinical Medicine, Copenhagen University, Sygehusvej 10, 4000, Roskilde, Denmark. Electronic address: nesa@regionsjaelland.dk.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109343']
1501,33120301,"Analgesic efficacy of ketamine and magnesium after laparoscopic sleeve gastrectomy: A randomized, double-blind, placebo-controlled trial.","Background Ketamine and magnesium are antagonists of the N-methyl-d-aspartate receptor, and are valuable adjuvants for multimodal analgesia and opioid sparing. Data are limited regarding the opioid sparing efficacy of the combined intraoperative application of these agents in laparoscopic bariatric surgery. The objective of this study was to compare the postoperative opioid sparing properties of a single intraoperative dose of ketamine versus a combination of single doses of ketamine and magnesium after laparoscopic gastric sleeve resection in bariatric patients. Methods One hundred and twenty- six patients were randomly assigned to receive single boluses of ketamine alone 0.5 mg kg -1 IV (ketamine group); combined ketamine bolus of 0.5 mg kg -1 IV and magnesium 2 g IV (ketamine and magnesium group); or placebo. Opioid consumption at 24 h (in morphine equivalents); pain at rest; postoperative nausea and vomiting impact score; sedation scores; and trends of transcutaneous carbon-di-oxide values were analysed. Results The median (inter-quartile range [range]) morphine consumption at 24 h were 32 (24-47 [4.8-91]) mg in the ketamine group, 37 (18-53 [1-144]) mg in the ketamine and magnesium group, and 26 (21-36 [5-89]) mg in the control group and were not significantly different between the groups. There were no differences for all other outcomes examined. Conclusion Combined single intraoperative bolus doses of ketamine and magnesium did not result in postoperative opioid sparing after laparoscopic gastric sleeve resection.",2020,morphine consumption at 24 h were 32,"['after laparoscopic gastric sleeve resection', 'bariatric patients', 'Methods One hundred and twenty- six patients', 'after laparoscopic sleeve gastrectomy', 'consumption at 24\xa0h were 32']","[' Ketamine and magnesium', 'laparoscopic gastric sleeve resection', 'ketamine', 'ketamine alone 0.5\xa0mg\xa0kg -1 IV (ketamine group); combined ketamine bolus of 0.5\xa0mg\xa0kg -1 IV and magnesium 2\xa0g IV (ketamine and magnesium group); or placebo', 'placebo', 'ketamine and magnesium', 'morphine']","['Opioid consumption', 'nausea and vomiting impact score; sedation scores', 'transcutaneous carbon-di-oxide values', 'Analgesic efficacy', 'postoperative opioid sparing']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4758637', 'cui_str': 'Gastric sleeve'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4758637', 'cui_str': 'Gastric sleeve'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0030015', 'cui_str': 'Oxides'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}]",126.0,0.636448,morphine consumption at 24 h were 32,"[{'ForeName': 'Sanjib Das', 'Initials': 'SD', 'LastName': 'Adhikary', 'Affiliation': 'Penn State Hershey Medical Center, Department of Anesthesiology and Perioperative Medicine, Penn State College of Medicine, 500 University Drive, Hershey, PA 17033, United States of America. Electronic address: sadhikary@pennstatehealth.psu.edu.'}, {'ForeName': 'Venkatesan', 'Initials': 'V', 'LastName': 'Thiruvenkatarajan', 'Affiliation': 'The Queen Elizabeth Hospital, Department of Anaesthesia, The University of Adelaide, Woodville South, SA 5011, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McFadden', 'Affiliation': 'St. Claire Hospital, Department of Anesthesiology, 1000 Bower Hill Rd, Pittsburgh, PA 15243, United States of America.'}, {'ForeName': 'Wai Man', 'Initials': 'WM', 'LastName': 'Liu', 'Affiliation': 'Research School of Finance, Actuarial Studies and Statistics, Australian National University, Canberra ACT 0200, Australian Capital Territory, Australia.'}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Mets', 'Affiliation': 'Penn State Hershey Medical Center, Department of Anesthesiology and Perioperative Medicine, Penn State College of Medicine, 500 University Drive, Hershey, PA 17033, United States of America.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'Penn State Hershey Medical Center, Surgical Weight Loss Program, Penn State College of Medicine, 500 University Drive, Hershey, PA 17033, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110097']
1502,33120302,Ketamine vs. haloperidol for prevention of cognitive dysfunction and postoperative delirium: A phase IV multicentre randomised placebo-controlled double-blind clinical trial.,"STUDY OBJECTIVE
Delirium is frequently observed in the postoperative and intensive care unit (ICU) population. Due to the multifactorial origin of delirium and according to international guidelines (e.g., American Geriatrics Society; Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption (PADIS) guideline), there are several but no incontestable options for prevention and symptomatic treatment. The purpose of the Baden PRIDe (Prevention and Reduction of Incidence of postoperative Delirium) trial was to determine whether postoperative cognitive dysfunction and delirium could be prevented by the combination of possible preventive agents such as haloperidol and ketamine. In addition, pre- and postoperative levels of the biomarkers cortisol, neuron specific enolase (NSE) and S100β were measured to investigate their dynamics in delirious and non-delirious patients after surgery.
DESIGN
The Baden PRIDe Trial was an investigator-initiated, phase IV, two-centre, randomised, placebo-controlled, double-blind clinical trial.
SETTING
Perioperative care.
PATIENTS
182 adult patients that underwent elective or emergency surgery under general or combined (i.e., general and regional) anaesthesia.
INTERVENTIONS
Pre-anaesthetic, pharmacologic prevention of postoperative brain dysfunction with haloperidol, ketamine, and the combination of both vs. placebo.
MEASUREMENTS
Assessment of cognitive performance pre- and postoperatively with the MMSE, the DOS, the Nursing Delirium Screening Scale (Nu-DESC) or the Intensive Care Delirium Screening Checklist (ICDSC) during ICU stay.
MAIN RESULTS
None of the three study arms - haloperidol, ketamine, or both drugs combined - was significantly superior to placebo for prevention of postoperative brain dysfunction and delirium (P = 0.39). Measured levels of postoperative cortisol were significantly higher in delirious patients. S-100β levels were significantly higher in all postoperative outcome groups (cognitive impairment, delirium, no cognitive decline), whereas postoperative NSE levels declined in all groups.
CONCLUSIONS
The study results offer no possibility for a novel recommendation for prevention of postoperative cognitive decline including delirium. Perioperative S-100β trajectories in patients with cognitive deterioration suggest affection of glial cells in particular.
TRIAL REGISTRATION
ClinicalTrials.govNCT02433041; registered on April 7, 2015.",2020,"S-100β levels were significantly higher in all postoperative outcome groups (cognitive impairment, delirium, no cognitive decline), whereas postoperative NSE levels declined in all groups.
","['patients with cognitive deterioration suggest affection of glial cells in particular', '182 adult patients that underwent elective or emergency surgery under general or combined (i.e., general and regional) anaesthesia']","['haloperidol, ketamine', 'Ketamine vs. haloperidol', 'haloperidol and ketamine', 'placebo', 'haloperidol, ketamine, and the combination of both vs. placebo']","['pre- and postoperative levels of the biomarkers cortisol, neuron specific enolase (NSE) and S100β', 'cognitive dysfunction and postoperative delirium', 'postoperative NSE levels', 'cognitive performance pre- and postoperatively with the MMSE, the DOS, the Nursing Delirium Screening Scale (Nu-DESC) or the Intensive Care Delirium Screening Checklist (ICDSC) during ICU stay', 'Measured levels of postoperative cortisol', 'S-100β levels', 'postoperative brain dysfunction and delirium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0854193', 'cui_str': 'Cognitive deterioration'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",182.0,0.394449,"S-100β levels were significantly higher in all postoperative outcome groups (cognitive impairment, delirium, no cognitive decline), whereas postoperative NSE levels declined in all groups.
","[{'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Hollinger', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland; Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland. Electronic address: Alexa.Hollinger@usb.ch.'}, {'ForeName': 'Christoph A', 'Initials': 'CA', 'LastName': 'Rüst', 'Affiliation': 'Institute of Primary Care, University of Zurich, Pestalozzistrasse 24, 8091 Zurich, Switzerland. Electronic address: christoph.ruest@bluewin.ch.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Riegger', 'Affiliation': 'Department for Anesthesia, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: HarrietYvonne.Riegger@usb.ch.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Gysi', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: bianca.gysi@stud.unibas.ch.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Tran', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: fabian.tran@stud.unibas.ch.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Brügger', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: jonas.bruegger@stud.unibas.ch.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Huber', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: jan.huber@vtxmail.ch.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Toft', 'Affiliation': 'Department for Anaesthesia, Intensive Care and Emergency Medicine, See-Spital, Horgen and Kilchberg Branches, Asylstrasse 19, 8810 Horgen, Switzerland. Electronic address: Katharina.Toft@gmail.com.'}, {'ForeName': 'Madlen', 'Initials': 'M', 'LastName': 'Surbeck', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: madlen.surbeck@stud.unibas.ch.'}, {'ForeName': 'Hans-Ruedi', 'Initials': 'HR', 'LastName': 'Schmid', 'Affiliation': 'Central Laboratory, Cantonal Hospital Baden, Im Ergel 1, 5404 Baden, Switzerland. Electronic address: Hans-Ruedi.Schmid@ksb.ch.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Rentsch', 'Affiliation': 'Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland; Department of Clinical Chemistry and Laboratory Medicine, Petersgraben 4, 4031 Basel, Switzerland. Electronic address: Katharina.Rentsch@usb.ch.'}, {'ForeName': 'Luzius', 'Initials': 'L', 'LastName': 'Steiner', 'Affiliation': 'Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland; Department for Anesthesia, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: Luzius.Steiner@usb.ch.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siegemund', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland; Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland. Electronic address: Martin.Siegemund@usb.ch.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110099']
1503,33132623,Orthostatic retractor placement reduces operating time and post-operative inflammatory response during the learning curve of anterior approach THA.,"Introduction
Handheld retractor placement (HHRP) is prone to repetitive repositioning. This could lead to muscle damage especially during a procedure with a steep learning curve. In an attempt to minimize retractor repositioning during the learning curve of direct anterior approach (DAA) total hip arthroplasty (THA), we used a table mounted orthostatic retractor placement (ORP) device.
Purpose
To investigate whether ORP would reduce the extent of muscle damage, OR-time and post-operative inflammatory response.
Materials and methods
29 Patients were operated by 2 surgeons who randomly used HHRP or ORP during their learning curve of DAA THA. There were 14 patients in a control group who were operated by an experienced surgeon. Blood levels of Creatine Kinase (CK), C-Reactive Protein (CRP), Hemoglobin (Hb), Lactate Dehydrogenase (LDH) and Erythrocyte Sedimentation Rate (ESR) were measured at 1 h pre- and 24 and 48 h post-operatively.
Results
The mean OR-time was 67 and 50 min in the HHRP and ORP cohort, respectively (p < 0,001). Post-operative CRP levels were significantly higher in the HHRP cohort at 24 h (HHRP 60.64 mg/L (25.20-143.20); ORP 34.67 mg/L (9.30-71.20)) (p = 0.003) and 48 h post-operatively (HHRP 154.54 mg/L (65.90-369.00); ORP 81.60 mg/L (21.30-219.40) (p = 0.004). The post-operative Hb-levels were significantly lower in the HHRP cohort at 24 h (HHRP 11.11 g/dL (9.10-12.30); ORP 11.37 g/dL (8.80-14.00)) (p = 0.0008) and 48 h (HHRP 10.86 g/dL (9.50-12.00); ORP 11.25 g/dL (8.60-14.10)) (p = 0.03). Post-operative ESR levels were significantly higher in the HHRP cohort 48 h post-op (HHRP 45.21 mm/h (14.00-83.00); ORP 23.73 mm/h (2.00-73.00)) (p = 0.004). No significant differences were found for the CK and LDH levels at any time postoperatively. There were no complications in any group.
Conclusion
The use of an orthostatic retractor placement device allows for reducing the OR-time, post-operative blood loss and post-operative inflammatory response during the learning curve of DAA THA.",2020,Post-operative CRP levels were significantly higher in the HHRP cohort at 24 h (HHRP 60.64 mg/L (25.20-143.20); ORP 34.67 mg/L (9.30-71.20)),"['14 patients in a control group who were operated by an experienced surgeon', '29 Patients were operated by 2 surgeons who randomly used HHRP or ORP during their learning curve of DAA THA']","['Orthostatic retractor placement', 'table mounted orthostatic retractor placement (ORP) device', 'Introduction\n\n\nHandheld retractor placement (HHRP', 'ORP', 'orthostatic retractor placement device', 'direct anterior approach (DAA) total hip arthroplasty (THA']","['post-operative Hb-levels', 'Post-operative CRP levels', 'CK and LDH levels', 'Post-operative ESR levels', 'mean OR-time', 'Blood levels of Creatine Kinase (CK), C-Reactive Protein (CRP), Hemoglobin (Hb), Lactate Dehydrogenase (LDH) and Erythrocyte Sedimentation Rate (ESR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0183014', 'cui_str': 'Retractor'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0183014', 'cui_str': 'Retractor'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0181909', 'cui_str': 'Mount'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}]",29.0,0.0484692,Post-operative CRP levels were significantly higher in the HHRP cohort at 24 h (HHRP 60.64 mg/L (25.20-143.20); ORP 34.67 mg/L (9.30-71.20)),"[{'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Opsomer', 'Affiliation': 'Department of Orthopaedic Surgery, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Frans-Jozef', 'Initials': 'FJ', 'LastName': 'Vandeputte', 'Affiliation': 'Department of Orthopaedic Surgery, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Cigdem', 'Initials': 'C', 'LastName': 'Sarac', 'Affiliation': 'Department of Orthopaedic Surgery, Ziekenhuis Oost-Limburg, Genk, Belgium.'}]",Journal of orthopaedics,['10.1016/j.jor.2020.10.011']
1504,33132625,The influence of arthroscopy on the classification and treatment of tibial plateau fractures.,"Introduction
Arthroscopically-assisted reduction and percutaneous fixation of tibial plateau fractures is associated with fewer adverse events, better knee motion, and better Rasmussen functional scores compared to open reduction internal fixation in a number of non-randomized studies. The purpose of this study was to measure the influence of arthroscopy on the interobserver reliability in classification, treatment, and evaluation of intra-articular pathology and fracture reduction for fractures of the tibial plateau.
Methods
Surgeons were invited to participate in this online survey study. Surgeons were randomized at a 1:1 ratio to review eight cases of patients with tibial plateau fractures with either 1) knee radiographs alone or 2) radiographs and arthroscopic images. Multirater kappa was used to assess chance-corrected interobserver agreement.
Results
There was no difference in interobserver agreement between groups for classification, treatment choice, determination of intra-articular pathology, or evaluation of fracture reduction.
Conclusions
Arthroscopy may not influence classification, treatment choice, diagnosis of intra-articular pathology, or quality of fracture reduction. Future studies will be necessary to determine if arthroscopic-assisted fixation of tibial plateau fractures is generalizable to surgeons of different training backgrounds.",2020,"There was no difference in interobserver agreement between groups for classification, treatment choice, determination of intra-articular pathology, or evaluation of fracture reduction.
",['tibial plateau fractures'],"['Introduction\n\n\nArthroscopically-assisted reduction and percutaneous fixation of tibial plateau fractures', 'tibial plateau fractures with either 1) knee radiographs alone or 2) radiographs and arthroscopic images']",[],"[{'cui': 'C0262489', 'cui_str': 'Fracture of tibial plateau'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441551', 'cui_str': 'Percutaneous fixation of bone'}, {'cui': 'C0262489', 'cui_str': 'Fracture of tibial plateau'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",[],,0.0200608,"There was no difference in interobserver agreement between groups for classification, treatment choice, determination of intra-articular pathology, or evaluation of fracture reduction.
","[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Tatman', 'Affiliation': 'Department of Orthopaedic Surgery, University of Minnesota, 2512 South 7th Street, Suite R200, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Joost T P', 'Initials': 'JTP', 'LastName': 'Kortlever', 'Affiliation': 'Department of Surgery and Perioperative Care, Dell Medical School, The University of Texas at Austin, 1701 Trinity Street, Austin, TX, 78705, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Cunningham', 'Affiliation': 'Department of Orthopaedic Surgery, University of Minnesota, 2512 South 7th Street, Suite R200, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ring', 'Affiliation': 'Department of Surgery and Perioperative Care, Dell Medical School, The University of Texas at Austin, 1701 Trinity Street, Austin, TX, 78705, USA.'}, {'ForeName': 'Marc F', 'Initials': 'MF', 'LastName': 'Swiontkowski', 'Affiliation': 'Department of Orthopaedic Surgery, University of Minnesota, 2512 South 7th Street, Suite R200, Minneapolis, MN, 55455, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of orthopaedics,['10.1016/j.jor.2020.10.007']
1505,33132658,Impact of cap-assisted colonoscopy during transendoscopic enteral tubing: A randomized controlled trial.,"BACKGROUND
Colonic transendoscopic enteral tubing (TET) requires double cecal intubation, raising a common concern of how to save cecal intubation time and make the tube stable. We hypothesized that cap-assisted colonoscopy (CC) might reduce the second cecal intubation time and bring potential benefits during the TET procedure.
AIM
To investigate if CC can decrease the second cecal intubation time compared with regular colonoscopy (RC).
METHODS
This prospective multicenter, randomized controlled trial was performed at four centers. Subjects ≥ 7 years needing colonic TET were recruited from August 2018 to January 2020. All subjects were randomly assigned to two groups. The primary outcome was the second cecal intubation time. Secondary outcomes included success rate, insertion pain score, single clip fixation time, purpose and retention time of TET tube, length of TET tube inserted into the colon, and all procedure-related (serious) adverse events.
RESULTS
A total of 331 subjects were randomized to the RC ( n = 165) or CC ( n = 166) group. The median time of the second cecal intubation was significantly shorter for CC than RC (2.2 min vs 2.8 min, P < 0.001). In patients with constipation, the median time of second cecal intubation in the CC group ( n = 50) was shorter than that in the RC group ( n = 43) (2.6 min vs 3.8 min, P = 0.004). However, no difference was observed in the CC ( n = 42) and RC ( n = 46) groups of ulcerative colitis patients (2.0 min vs 2.5 min, P = 0.152). The insertion pain score during the procedure in CC ( n = 14) was lower than that in RC ( n = 19) in unsedated colonoscopy (3.8 ± 1.7 vs 5.4 ± 1.9; P = 0.015). Multivariate analysis revealed that only CC (odds ratio [OR]: 2.250, 95% confidence interval [CI]: 1.161-4.360; P = 0.016) was an independent factor affecting the second cecal intubation time in difficult colonoscopy. CC did not affect the colonic TET tube's retention time and length of the tube inserted into the colon. Moreover, multivariate analysis found that only endoscopic clip number (OR: 2.201, 95%CI: 1.541-3.143; P < 0.001) was an independent factor affecting the retention time. Multiple regression analysis showed that height (OR: 1.144, 95%CI: 1.027-1.275; P = 0.014) was the only independent factor influencing the length of TET tube inserted into the colon in adults.
CONCLUSION
CC for colonic TET procedure is a safe and less painful technique, which can reduce cecal intubation time.",2020,"Multivariate analysis revealed that only CC (odds ratio [OR]: 2.250, 95% confidence interval [CI]: 1.161-4.360; P = 0.016) was an independent factor affecting the second cecal intubation time in difficult colonoscopy.","['331 subjects', 'Subjects ≥ 7 years needing colonic TET were recruited from August 2018 to January 2020']","['cap-assisted colonoscopy', 'transendoscopic enteral tubing', 'CC', 'cap-assisted colonoscopy (CC', 'Colonic transendoscopic enteral tubing (TET', 'regular colonoscopy (RC']","['success rate, insertion pain score, single clip fixation time, purpose and retention time of TET tube, length of TET tube inserted into the colon, and all procedure-related (serious) adverse events', 'median time of the second cecal intubation', 'second cecal intubation time', 'median time of second cecal intubation', 'cecal intubation time', 'insertion pain score', ""colonic TET tube's retention time and length of the tube inserted into the colon""]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",331.0,0.0908734,"Multivariate analysis revealed that only CC (odds ratio [OR]: 2.250, 95% confidence interval [CI]: 1.161-4.360; P = 0.016) was an independent factor affecting the second cecal intubation time in difficult colonoscopy.","[{'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wen', 'Affiliation': 'Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, Jiangsu Province, China.'}, {'ForeName': 'Kang-Jian', 'Initials': 'KJ', 'LastName': 'Liu', 'Affiliation': 'Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, Jiangsu Province, China.'}, {'ForeName': 'Bo-Ta', 'Initials': 'BT', 'LastName': 'Cui', 'Affiliation': 'Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, Jiangsu Province, China.'}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, Jiangsu Province, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, Jiangsu Province, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhong', 'Affiliation': 'Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, Jiangsu Province, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, Jiangsu Province, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Tu', 'Affiliation': 'Department of Spleen and Stomach Diseases, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, Hubei Province, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou 510080, Guangdong Province, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou 510080, Guangdong Province, China.'}, {'ForeName': 'Wen-Hung', 'Initials': 'WH', 'LastName': 'Hsu', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Deng-Chyang', 'Initials': 'DC', 'LastName': 'Wu', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': ""Department of Gastroenterology, Zigong Fourth People's Hospital, Zigong 643000, Sichuan Province, China.""}, {'ForeName': 'Fa-Ming', 'Initials': 'FM', 'LastName': 'Zhang', 'Affiliation': 'Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, Jiangsu Province, China.'}]",World journal of gastroenterology,['10.3748/wjg.v26.i39.6098']
1506,33132924,"PEPSUI, a Psychoeducational Program for the Management of Suicidal Patients: A Qualitative Study From a Randomized Controlled Trial.","Background
Suicide prevention after a recent suicide attempt remains a major issue for clinicians. Indeed, these patients are at risk of new attempts and also less prone to interact with mental health services. As psychoeducation-based interventions are strongly recommended for patients with severe or chronic disorders and poor adherence, we developed the first French program of suicide psychoeducation (PEPSUI).
Methods
We started a large multicenter randomized controlled trial in outpatients who attempted suicide in the last year (i.e., current suicidal behavior disorder) to assess the feasibility, acceptability, and effectiveness of a 10-week psychoeducational program (PEPSUI group: scientific information on suicidal behavior, and third-wave cognitive behavioral therapies) compared with a 10-week relaxation program (control condition), in a naturalistic setting. Here, we present the qualitative part of this study. Participants in both groups completed a narrative interview with questions on their general impressions about the therapy process and outcomes, specific areas of change in their life since inclusion, and knowledge and perceptions about suicide and mental health services. Interviews were audiotaped, transcribed, and coded using inductive and deductive thematic analysis with a constant comparative approach. Participants were consecutively included until data saturation.
Results
The interviews of 18 patients (n=10 in the PEPSUI group, and n=8 in the relaxation group) were analyzed. Qualitative analyses revealed some common points, and many differences between groups that are relevant for suicide prevention. Patients in both groups were satisfied with the programs. Group modality and therapeutic alliance with the instructors were considered useful in both groups. Participation was related to improved perception of mental health units (particularly in the PEPSUI group). Both groups reported the acquisition of stress management skills and distress tolerance. Relaxation was an easy way to survive stress. Conversely, the PEPSUI program had deeper implications for daily life through effective positioning towards internal events (thoughts and emotions) as a consequence of mindfulness-derived practices, enhancement of value-based commitments, improvement of the meaning in life and internal locus of control, increased contact with the present moment, use of a matrix (a decision-making tool), and acquisition of scientific knowledge on suicidal behavior.
Conclusion
Through specific processes for targeting suicidal risk and reducing the stigma, the PEPSUI program may represent a promising intervention for suicide prevention.",2020,"Conversely, the PEPSUI program had deeper implications for daily life through effective positioning towards internal events (thoughts and emotions) as a consequence of mindfulness-derived practices, enhancement of value-based commitments, improvement of the meaning in life and internal locus of control, increased contact with the present moment, use of a matrix (a decision-making tool), and acquisition of scientific knowledge on suicidal behavior.
","['outpatients who attempted suicide in the last year (i.e., current suicidal behavior disorder', '18 patients (n=10 in the PEPSUI group, and n=8 in the relaxation group) were analyzed', 'Participants were consecutively included until data saturation', 'Suicidal Patients', 'patients with severe or chronic disorders and poor adherence']","['psychoeducational program (PEPSUI group: scientific information on suicidal behavior, and third-wave cognitive behavioral therapies) compared with a 10-week relaxation program (control condition']","['acquisition of stress management skills and distress tolerance', 'perception of mental health units']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",18.0,0.0560561,"Conversely, the PEPSUI program had deeper implications for daily life through effective positioning towards internal events (thoughts and emotions) as a consequence of mindfulness-derived practices, enhancement of value-based commitments, improvement of the meaning in life and internal locus of control, increased contact with the present moment, use of a matrix (a decision-making tool), and acquisition of scientific knowledge on suicidal behavior.
","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Henrion', 'Affiliation': 'CHU Montpellier, Lapeyronie Hospital, Department of Emergency Psychiatry and Post Acute Care, CHRU Montpellier, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Courtet', 'Affiliation': 'CHU Montpellier, Lapeyronie Hospital, Department of Emergency Psychiatry and Post Acute Care, CHRU Montpellier, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Arpon-Brand', 'Affiliation': 'CHU Montpellier, Lapeyronie Hospital, Department of Emergency Psychiatry and Post Acute Care, CHRU Montpellier, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Lafrancesca', 'Affiliation': 'CHU Montpellier, Lapeyronie Hospital, Department of Emergency Psychiatry and Post Acute Care, CHRU Montpellier, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Lacourt', 'Affiliation': 'CHU Montpellier, Lapeyronie Hospital, Department of Emergency Psychiatry and Post Acute Care, CHRU Montpellier, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Jaussent', 'Affiliation': 'INSERM U1061, Neuropsychiatry: Epidemiological and Clinical Research, Montpellier, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Guillaume', 'Affiliation': 'CHU Montpellier, Lapeyronie Hospital, Department of Emergency Psychiatry and Post Acute Care, CHRU Montpellier, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Olié', 'Affiliation': 'CHU Montpellier, Lapeyronie Hospital, Department of Emergency Psychiatry and Post Acute Care, CHRU Montpellier, France.'}, {'ForeName': 'Déborah', 'Initials': 'D', 'LastName': 'Ducasse', 'Affiliation': 'CHU Montpellier, Lapeyronie Hospital, Department of Emergency Psychiatry and Post Acute Care, CHRU Montpellier, France.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.500447']
1507,33132951,Effects of a Mindfulness Intervention Among Arab Teachers Are Mediated by Decentering: A Pilot Study.,"Although mindfulness-based interventions (MBIs) in education are widely spreading in the world, examination of mindfulness effects in Arab schools is still scarce. This pilot study aimed to fill this gap by examining the effects of an MBI among Arab teachers in Israel. This examination was conducted within the framework of the mindful self in school relationships (MSSR) model, which suggests that the positive effects of MBI on teachers' emotion regulation are mediated by decentering. The participants ( N = 39) were teachers from two Arab elementary schools in Israel, who underwent an MBI course (the MBI condition, N = 20) and another cognitive intervention (the control condition, N = 19). In a pre-post design, participants completed mindfulness, decentering, emotion regulation, and stress questionnaires. We hypothesized that (1) only in the MBI group, teachers' mindfulness, decentering, and emotional regulation will increase and stress will decrease, and (2) changes in teachers' decentering would mediate the associations of changes in teachers' mindfulness with changes in their emotion regulation. ANOVA analyses show that, only in the MBI condition, teachers showed an increase in three mindfulness subscales (acting with awareness, non-reactivity, and observance), in decentering, and in adaptive emotion regulation (reappraisal) and a decrease in stress. Furthermore, changes from pre-intervention to post-intervention in teachers' decentering mediated the associations of their pre-post changes in mindfulness with changes in emotion regulation. This study provides initial support to the feasibility and efficacy of MBI among Israeli Arab teachers and suggests decentering as a potential mediator of its effects in initial support of the MSSR model.",2020,"ANOVA analyses show that, only in the MBI condition, teachers showed an increase in three mindfulness subscales (acting with awareness, non-reactivity, and observance), in decentering, and in adaptive emotion regulation (reappraisal) and a decrease in stress.","['participants ( N = 39) were teachers from two Arab elementary schools in Israel, who underwent an MBI course (the MBI condition, N = 20) and another cognitive intervention (the control condition, N = 19', 'Arab teachers in Israel']","['mindfulness-based interventions (MBIs', 'MBI', 'Mindfulness Intervention']","['stress', 'three mindfulness subscales (acting with awareness, non-reactivity, and observance), in decentering, and in adaptive emotion regulation (reappraisal']","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",39.0,0.0164465,"ANOVA analyses show that, only in the MBI condition, teachers showed an increase in three mindfulness subscales (acting with awareness, non-reactivity, and observance), in decentering, and in adaptive emotion regulation (reappraisal) and a decrease in stress.","[{'ForeName': 'Aviva', 'Initials': 'A', 'LastName': 'Berkovich-Ohana', 'Affiliation': 'Department of Learning, Instruction and Teacher Education, Faculty of Education, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Lavy', 'Affiliation': 'Department of Leadership and Policy in Education, Faculty of Education, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Kholoud', 'Initials': 'K', 'LastName': 'Shanboor', 'Affiliation': 'Department of Learning, Instruction and Teacher Education, Faculty of Education, University of Haifa, Haifa, Israel.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.542986']
1508,33132963,Mediating Mechanisms of the Incredible Years Teacher Classroom Management Program.,"This study examined whether, and the extent to which, the Incredible Years Teacher Classroom Management program predicted positive development of children's emotional, behavioral, and social adjustment through changes in the child-teacher relationship. Using data from a longitudinal quasi-experimental intervention trial with a matched control condition, including 1,085 children (49.7% girls, mean age = 4.22 years; SD age = 0.88 years), the potential associations were tested by means of multilevel path modeling. The mediation model demonstrated that (1) children in the intervention condition achieved more favorable changes in the child-teacher relationship than the control condition; (2) changes in the child-teacher relationship were associated with changes in the target outcomes; and (3) the intervention effects were mediated via changes in the child-teacher relationship.",2020,The mediation model demonstrated that (1) children in the intervention condition achieved more favorable changes in the child-teacher relationship than the control condition; (2) changes in the child-teacher relationship were associated with changes in the target outcomes; and (3) the intervention effects were mediated via changes in the child-teacher relationship.,"['1,085 children (49.7% girls, mean age = 4.22 years; SD age = 0.88 years']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517484', 'cui_str': '0.88'}]",[],[],1085.0,0.0127648,The mediation model demonstrated that (1) children in the intervention condition achieved more favorable changes in the child-teacher relationship than the control condition; (2) changes in the child-teacher relationship were associated with changes in the target outcomes; and (3) the intervention effects were mediated via changes in the child-teacher relationship.,"[{'ForeName': 'Håvard Horndalen', 'Initials': 'HH', 'LastName': 'Tveit', 'Affiliation': 'The Regional Centre for Child and Youth Mental Health and Child Welfare - Central Norway, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'May Britt', 'Initials': 'MB', 'LastName': 'Drugli', 'Affiliation': 'The Regional Centre for Child and Youth Mental Health and Child Welfare - Central Norway, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Sturla', 'Initials': 'S', 'LastName': 'Fossum', 'Affiliation': 'The Regional Centre for Child and Youth Mental Health and Child Welfare - North, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Bjørn Helge', 'Initials': 'BH', 'LastName': 'Handegård', 'Affiliation': 'The Regional Centre for Child and Youth Mental Health and Child Welfare - North, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Klöckner', 'Affiliation': 'Department of Psychology, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Frode', 'Initials': 'F', 'LastName': 'Stenseng', 'Affiliation': 'Department of Education and Lifelong Learning, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.555442']
1509,33132968,The Development of Spatial Representation Through Teaching Block-Building in Kindergartners.,"This study investigated the effects of the teaching block-building intervention on overall spatial representation and its three sub-forms, namely linguistic, graphic and model representations, in kindergartners. Eighty-four children (39 girls and 45 boys), aged 5-6 years old, were randomly selected and equally divided into two groups, i.e., experimental group and control group. The experimental group received the intervention of teaching block-building for 14 weeks (45 min each time, once a week), while children in the control group freely played with blocks for the equivalent time. Children's spatial representation performances were measured in both pre- and post-tests by the Experimental Tasks of Spatial Representation for Children . The results showed that: (1) teaching block-building could promote not only the overall spatial representation but also all three sub-forms of spatial representations; (2) there was no gender differences regarding the effect of teaching block-building on neither the overall nor three sub-forms of spatial representations; (3) after the intervention, the diversity of children's choices regarding the use of sub-forms spatial representations was also promoted in the experimental group. In summary, these results contributed to a comprehensive and systematic understanding of the effects of teaching block-building on spatial representation among children in kindergartens.",2020,Children's spatial representation performances were measured in both pre- and post-tests by the Experimental Tasks of Spatial Representation for Children .,"['Eighty-four children (39 girls and 45 boys), aged 5-6 years old']",['teaching block-building intervention'],"[""Children's spatial representation performances"", 'overall spatial representation']","[{'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",84.0,0.0266356,Children's spatial representation performances were measured in both pre- and post-tests by the Experimental Tasks of Spatial Representation for Children .,"[{'ForeName': 'Liman', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': 'School of Education, South China Normal University, Guangzhou, China.'}, {'ForeName': 'Jiutong', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Advanced Innovation Center for Future Education, Faculty of Education, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Teacher's College, Shihezi University, Shihezi, China.""}, {'ForeName': 'Jinling', 'Initials': 'J', 'LastName': 'Ying', 'Affiliation': 'School of Education, South China Normal University, Guangzhou, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.565723']
1510,33132978,Effects of an Early Literacy Intervention for Linguistically Diverse Children: A Quasi-Experimental Study.,"Phonological awareness and letter-sound knowledge underpin children's early literacy acquisition. Promoting these foundational skills in kindergarten should therefore lead to a better response to formal literacy instruction once started. The present study evaluated a 12-week early literacy intervention for linguistically diverse children who are learning to read in German. The study was set in Luxembourg where kindergarten education is in Luxembourgish and children learn to read in German in Grade 1 of primary school. One hundred and eighty-nine children (mean age = 5;8 years) were assigned to an early literacy intervention in Luxembourgish or to a business as usual control group. Trained teachers delivered the intervention to entire classes, four times a week, during the last year of kindergarten. The early literacy program included direct instruction in phonological awareness and letter-knowledge, while promoting print and book awareness and literacy engagement. Children were assessed pre-intervention, immediately post-intervention and at a 9 months delayed follow-up using measures in Luxembourgish and in German. At the end of the intervention, children in the intervention group performed significantly better than the control group on phonological awareness and letter-knowledge measures in Luxembourgish and the gains in phonological awareness were maintained at 9 months follow-up. The effects generalized to measures of phonological awareness, word-level reading comprehension and spelling in German (effect sizes d > 0.25), but not to German single word/pseudoword reading, at delayed follow-up. Intervention programs designed to support foundational literacy skills can be successfully implemented by regular teachers in a play-based kindergarten context. The findings suggest that early literacy intervention before school entry can produce educationally meaningful effects in linguistically diverse learners.",2020,"At the end of the intervention, children in the intervention group performed significantly better than the control group on phonological awareness and letter-knowledge measures in Luxembourgish and the gains in phonological awareness were maintained at 9 months follow-up.","['linguistically diverse children who are learning to read in German', 'Linguistically Diverse Children', 'One hundred and eighty-nine children (mean age ']","['early literacy intervention in Luxembourgish or to a business as usual control group', 'literacy intervention', 'Early Literacy Intervention']","['phonological awareness, word-level reading comprehension and spelling in German (effect sizes', 'phonological awareness and letter-knowledge, while promoting print and book awareness and literacy engagement', 'phonological awareness and letter-knowledge measures in Luxembourgish and the gains in phonological awareness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",189.0,0.0148567,"At the end of the intervention, children in the intervention group performed significantly better than the control group on phonological awareness and letter-knowledge measures in Luxembourgish and the gains in phonological awareness were maintained at 9 months follow-up.","[{'ForeName': 'Pascale M J', 'Initials': 'PMJ', 'LastName': 'Engel de Abreu', 'Affiliation': 'Institute for Research on Multilingualism, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Fricke', 'Affiliation': 'Division of Human Communication Sciences, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Wealer', 'Affiliation': 'Institute for Research on Multilingualism, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.569854']
1511,33133336,"Lidose-Isotretinoin Administered Without Food Improves Quality of Life in Patients With Severe Recalcitrant Nodular Acne: An Open-Label, Single-Arm, Phase IV Study.","OBJECTIVE: We sought to assess the impact of Lidose-isotretinoin taken without food on patient quality of life (QoL) at baseline, monthly intervals, and end of study in patients with severe recalcitrant nodular acne. DESIGN: In this open-label, single-arm, multicenter study, 197 patients took twice-daily Lidose-isotretinoin without food for 20 weeks (120-150mg/kg cumulative dosage). Patient visits occurred at Weeks 2, 4, 8, 12, 16, and 20. At baseline and Weeks 4, 8, 12, 16, and 20, patients underwent QoL and acne severity assessments and lesion counts. SETTING: Participants were enrolled from 21 sites across the United States. PARTICIPANTS: Eligible participants were 12 to 45 years of age, weighing 40 to 110kg, and with e;5 facial nodules and no prior exposure to systemic retinoids, including isotretinoin. Female participants were nonpregnant and nonlactating. MEASUREMENTS: An acne-specific QoL questionnaire (Acne-QoL) was used to assess QoL. Efficacy endpoints were lesion counts and Investigator Global Assessment (IGA) of acne severity. Safety assessments included reported adverse events. RESULTS: Lidose-isotretinoin taken without food significantly improved mean (standard deviation) overall Acne-QoL score from baseline (61.6 [28.7]) to end of treatment (101.8 [16.9]; P <0.0001). Improvements were shown in both male and female patients. Significant improvements in patient QoL (overall and by questionnaire domain), lesion counts, and IGA scores were observed as early as Week 4 and continued to improve throughout treatment. CONCLUSION: Twice-daily Lidose-isotretinoin taken without food for 20 weeks significantly improved patient QoL from Week 4.",2020,"Significant improvements in patient QoL (overall and by questionnaire domain), lesion counts, and IGA scores were observed as early as Week 4 and continued to improve throughout treatment. ","['Patients With Severe Recalcitrant Nodular Acne', 'Participants were enrolled from 21 sites across the United States', 'male and female patients', ' Eligible participants were 12 to 45 years of age, weighing 40 to 110kg, and with e;5 facial nodules and no prior exposure to systemic retinoids, including isotretinoin', 'Female participants were nonpregnant and nonlactating', 'patients with severe recalcitrant nodular acne', '197 patients took']","['twice-daily Lidose-isotretinoin without food', 'Lidose-isotretinoin taken without food', 'Lidose-Isotretinoin Administered Without Food']","['lesion counts and Investigator Global Assessment (IGA) of acne severity', 'patient QoL (overall and by questionnaire domain), lesion counts, and IGA scores', 'Quality of Life', 'mean (standard deviation) overall Acne-QoL score', 'patient QoL', 'adverse events', 'QoL and acne severity assessments and lesion counts', 'Patient visits', 'patient quality of life (QoL', 'acne-specific QoL questionnaire (Acne-QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1274727', 'cui_str': 'Acne nodule'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0035339', 'cui_str': 'Retinoid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022265', 'cui_str': 'Isotretinoin'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0022265', 'cui_str': 'Isotretinoin'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",197.0,0.039534,"Significant improvements in patient QoL (overall and by questionnaire domain), lesion counts, and IGA scores were observed as early as Week 4 and continued to improve throughout treatment. ","[{'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Zaenglein', 'Affiliation': 'Dr. Zaenglein is with Departments of Dermatology and Pediatrics at Penn State College of Medicine, Hershey Medical Center in Hershey, Pennsylvania.'}, {'ForeName': 'Jeanett', 'Initials': 'J', 'LastName': 'Segal', 'Affiliation': 'Dr. Zaenglein is with Departments of Dermatology and Pediatrics at Penn State College of Medicine, Hershey Medical Center in Hershey, Pennsylvania.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Darby', 'Affiliation': 'Dr. Zaenglein is with Departments of Dermatology and Pediatrics at Penn State College of Medicine, Hershey Medical Center in Hershey, Pennsylvania.'}, {'ForeName': 'James Q', 'Initials': 'JQ', 'LastName': 'Del Rosso', 'Affiliation': 'Dr. Zaenglein is with Departments of Dermatology and Pediatrics at Penn State College of Medicine, Hershey Medical Center in Hershey, Pennsylvania.'}]",The Journal of clinical and aesthetic dermatology,[]
1512,33133403,Are Three Doses of Intravenous Tranexamic Acid more Effective than Single Dose in Reducing Blood Loss During Bilateral Total Knee Arthroplasty?,"Purpose
Tranexamic acid (TXA) has shown to reduce perioperative blood loss after bilateral total knee arthroplasty (TKA). But dosage and schedule of administration are not clear in literature. This study was aimed to compare prospectively blood loss and transfusion requirement in bilateral TKA with 3-dose regimen versus a single intra-operative dose of intravenous TXA.
Methods
This prospective non-randomised controlled trial included 25 patients undergoing bilateral simultaneous TKA who received three doses of 1 g intravenous TXA (group 1). First dose was given prior to deflation of the tourniquet, followed by two more doses 6 h apart. The control group included 25 matched patients (group 2) receiving a single dose of 1 g intravenous TXA just prior to deflation of the tourniquet.
Results
Mean drop in haemoglobin was less in group 1 as compared to group 2, but this difference was not statistically significant (2.51 vs 2.93 g/dL, p = 0.210). Similarly mean drop in haematocrit was more in group 2 as compared to group 1, though it was not statistically significant (9.34 vs. 9.18, p = 0.868). The need for blood transfusions was more in group 2 compared to group 1, but this difference was not statistically significant ( p = 0.601). Higher frequency of ecchymosis around the surgical site was noted in group 2 as compared to group 1, for which prophylactic low-molecular-weight heparin had to be stopped post-operatively, but this difference was not statistically significant ( p = 0.065).
Conclusion
The study has failed to show any significant beneficial effect of three doses of TXA in TKA as compared to a single dose. Though a trend towards reduction in mean haemoglobin drop and decreased need for stopping LMWH in post-operative period was seen, the results were not statistically significant.
Level of Evidence
II, prospective non-randomised controlled trial.",2020,"Similarly mean drop in haematocrit was more in group 2 as compared to group 1, though it was not statistically significant (9.34 vs. 9.18, p = 0.868).","['25 patients undergoing bilateral simultaneous TKA who received three doses of 1 g', 'after bilateral total knee arthroplasty (TKA']","['Tranexamic acid (TXA', 'intravenous TXA', 'Tranexamic Acid', 'TXA', 'TXA just prior to deflation of the tourniquet']","['haematocrit', 'perioperative blood loss', 'mean haemoglobin', 'Higher frequency of ecchymosis', 'Mean drop in haemoglobin', 'Blood Loss', 'need for blood transfusions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}]","[{'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",25.0,0.18832,"Similarly mean drop in haematocrit was more in group 2 as compared to group 1, though it was not statistically significant (9.34 vs. 9.18, p = 0.868).","[{'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Goyal', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, Bathinda, Punjab 151001 India.'}, {'ForeName': 'Arghya Kundu', 'Initials': 'AK', 'LastName': 'Choudhury', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, Rishikesh, India.'}, {'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Gupta', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, Rishikesh, India.'}]",Indian journal of orthopaedics,['10.1007/s43465-020-00231-2']
1513,33133404,Efficacy of Periarticular Cocktail Injection in Rheumatoid Patients Undergoing Total Knee Replacement.,"Background
Pain control after total knee replacement (TKR) is of primary importance to joint replacement surgeons to achieve good functional outcome post-surgery. This becomes even more challenging when these major procedures are done in immunocompromised patients like rheumatoid arthritis. Good peri-operative analgesia facilitates early rehabilitation, improves patient satisfaction, and reduces the hospital stay. The adverse effects caused by epidural analgesia or parenteral opioids can be avoided by replacing it with an analgesic cocktail locally. Our prospective study was to evaluate the benefits of a periarticular cocktail injection which was given in rheumatoid patients undergoing bilateral TKR in single sitting with respect to pain and knee motion recovery.
Methods
Sixty-four rheumatoid arthritis patients undergoing simultaneous primary total knee replacement were included in the study. A total of 128 knees were randomized either to receive a periarticular intra-operative injection containing ropivacaine, fentanyl, clonidine, cefuroxime and epinephrine (Group A) on one knee and to receive plain ropivacaine (Group B) on the opposite knee. The perioperative and post-operative analgesic regimens were standardized. All patients received the same standard analgesia protocol. Visual analog scores for pain, knee range of motion and quadriceps function were recorded on the day of surgery, first post-operative day, second post-operative day, day of discharge, and 2 weeks and 6 weeks during follow-up. The need for rescue analgesic requirement and adverse effects to the cocktail injection were also noted during the study period.
Results
The patients who received the periarticular cocktail fared better in terms of pain scores and functional recovery. Additional rescue agents used were significantly less at 6 h, at 12 h, and over the first 24 h after the surgery in group A when compared with group B. No cardiac or central nervous system toxicity was observed.
Conclusions
Periarticular cocktail injection significantly reduces the requirements for post-operative analgesia and also improves patient satisfaction, with no apparent risks, following total knee arthroplasty in rheumatoid arthritis.",2020,"A total of 128 knees were randomized either to receive a periarticular intra-operative injection containing ropivacaine, fentanyl, clonidine, cefuroxime and epinephrine (Group A) on one knee and to receive plain ropivacaine (Group B) on the opposite knee.","['immunocompromised patients like rheumatoid arthritis', 'Rheumatoid Patients', 'rheumatoid patients undergoing bilateral TKR in single sitting with respect to pain and knee motion recovery', 'Undergoing Total Knee Replacement', 'Methods\n\n\nSixty-four rheumatoid arthritis patients undergoing simultaneous primary total knee replacement were included in the study', 'A total of 128 knees']","['periarticular cocktail injection', '\n\n\nPain control after total knee replacement (TKR', 'periarticular cocktail', 'Periarticular Cocktail Injection', 'plain ropivacaine', 'periarticular intra-operative injection containing ropivacaine, fentanyl, clonidine, cefuroxime and epinephrine']","['hospital stay', 'patient satisfaction', 'Visual analog scores for pain, knee range of motion and quadriceps function', 'pain scores and functional recovery', 'adverse effects', 'cardiac or central nervous system toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C3160947', 'cui_str': 'CNS toxicity'}]",128.0,0.071091,"A total of 128 knees were randomized either to receive a periarticular intra-operative injection containing ropivacaine, fentanyl, clonidine, cefuroxime and epinephrine (Group A) on one knee and to receive plain ropivacaine (Group B) on the opposite knee.","[{'ForeName': 'Nikhil Joseph', 'Initials': 'NJ', 'LastName': 'Martin', 'Affiliation': 'Department of Orthopaedic Surgery, Sree Sudheendra Medical Mission Hospital, Chittoor Road, Cochin, Kerala India.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Padmanabhan', 'Affiliation': 'Department of Orthopaedic Surgery, Sree Sudheendra Medical Mission Hospital, Chittoor Road, Cochin, Kerala India.'}, {'ForeName': 'Johny Joseph', 'Initials': 'JJ', 'LastName': 'Pindis', 'Affiliation': 'Department of Orthopaedic Surgery, Sree Sudheendra Medical Mission Hospital, Chittoor Road, Cochin, Kerala India.'}]",Indian journal of orthopaedics,['10.1007/s43465-020-00230-3']
1514,33133409,3D Printing Navigation Template Used in Total Hip Arthroplasty for Developmental Dysplasia of the Hip.,"Background
The purpose of our study was to explore the feasibility of 3D printing navigation template used in total hip arthroplasty (THA) for adult developmental dysplasia of the hip (DDH).
Materials and Methods
25 patients who received THA for DDH from February 2014 to May 2018 were randomized into the control or intervention group. Of these patients, 12 received THAs assisted with 3D printing navigation templates, 13 THAs underwent THAs without navigation templates. The mean follow-up was 1.6 (range, 1.2-3.8) years. Clinical scores and radiographic results were evaluated for two groups.
Results
Operating time, intra- and postoperative hemorrhage and Harris Hip Score (HHS) at 6 months postoperatively in the 3D printing group were better than those for patients in the conventional hip replacement group, while infection and implant loosening were 0 in the two groups. There were no significant differences in anteversion angle, abduction angle and the distance from rotation center to the ischial tuberosity line in 3D printing group as compared to the normal side. The abduction angle and the distance from rotation center to the ischial tuberosity line were significantly different between the two sides in the traditional group.
Conclusion
Application of the 3D printing template for THA with DDH can facilitate the surgical procedure and create an ideal artificial acetabulum placement.",2020,"There were no significant differences in anteversion angle, abduction angle and the distance from rotation center to the ischial tuberosity line in 3D printing group as compared to the normal side.","['total hip arthroplasty (THA) for adult developmental dysplasia of the hip (DDH', 'Of these patients, 12 received THAs assisted with 3D printing navigation templates, 13 THAs underwent THAs without navigation templates', 'Total Hip Arthroplasty for Developmental Dysplasia of the Hip', '25 patients who received THA for DDH from February 2014 to May 2018']",[],"['abduction angle and the distance from rotation center to the ischial tuberosity line', 'anteversion angle, abduction angle and the distance from rotation center to the ischial tuberosity line', 'Operating time, intra- and postoperative hemorrhage and Harris Hip Score (HHS']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4551649', 'cui_str': 'Congenital hip dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039245', 'cui_str': 'Tacrine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C4317132', 'cui_str': 'Template'}]",[],"[{'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0223656', 'cui_str': 'Ischial tuberosity structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0333053', 'cui_str': 'Anteversion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0041711', 'cui_str': 'United States. Dept. of Health and Human Services'}]",25.0,0.0232336,"There were no significant differences in anteversion angle, abduction angle and the distance from rotation center to the ischial tuberosity line in 3D printing group as compared to the normal side.","[{'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Department of Orthopedics, The Second Affiliate Hospital of Soochow University, Soochow, 215000 Jiangsu China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Nantong Rich Hospital, Nantong, 226300 Jiangsu China.'}, {'ForeName': 'Haibin', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopedics, The Second Affiliate Hospital of Soochow University, Soochow, 215000 Jiangsu China.'}]",Indian journal of orthopaedics,['10.1007/s43465-020-00093-8']
1515,33133601,Reasons for nonparticipation in the Valuing Active Life in Dementia randomised controlled trial of a dyadic occupational therapy intervention: An interview study.,"Objectives
There is currently little known about why people decline to participate in dyadic, psychosocial dementia research. This interview study aims to explore the reasons why people declined to participate in the Valuing Active Life in Dementia research trial.
Methods
Ten family carers of people with dementia, who were part of a dyad that had declined to take part in the randomised controlled trial, participated in qualitative telephone interviews to explore their reasons for declining. Inductive thematic analysis was used to identify themes.
Findings
Two themes with related sub-themes were identified: (1) Protectiveness - protecting the person with dementia, themselves as carers and their current lifestyle; (2) 'It's not for us' - the time commitment, and the possible unsuitability of the intervention, was seen to outweigh the perceived benefit of taking part. People with dementia were not always involved in the decision-making process, with carers stating the decision not to participate was made in the usual way as all their decisions. No apparent differences between the spousal and the child carers were apparent in the small sample.
Conclusion
Recruitment to randomised controlled trials can be considered difficult or unfair because some participants will miss out on the desired intervention. However, this study shows that concern about the time and inconvenience of being involved in the trial can put people off research participation. Identifying possible reasons for declining research participation contributes to the design of future trials and recruitment strategies, so that the potential benefit is considered relative to the time and effort involved. Offering research opportunities to people with dementia and their families at the right stage of the dementia trajectory for their needs, facilitating personalised recruitment strategies with finely tailored researcher communication skills should help maximise recruitment, reduce attrition and deliver a more successful trial.",2020,"People with dementia were not always involved in the decision-making process, with carers stating the decision not to participate was made in the usual way as all their decisions.","['Methods\n\n\nTen family carers of people with dementia, who were part of a dyad that had declined to take part', 'people with dementia and their families at the right stage', 'People with dementia']",['dyadic occupational therapy intervention'],[],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],10.0,0.0984533,"People with dementia were not always involved in the decision-making process, with carers stating the decision not to participate was made in the usual way as all their decisions.","[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Mundy', 'Affiliation': 'Essex Stroke Hub Team, North East London NHS Foundation Trust (NELFT), London, UK.'}, {'ForeName': 'Jacki', 'Initials': 'J', 'LastName': 'Stansfeld', 'Affiliation': 'Research and Development Department, North East London NHS Foundation Trust (NELFT), London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Orrell', 'Affiliation': 'Institute for Mental Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Cartwright', 'Affiliation': 'School of Health Sciences, City University of London, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wenborn', 'Affiliation': 'Research and Development Department, North East London NHS Foundation Trust (NELFT), London, UK.'}]",SAGE open medicine,['10.1177/2050312120958926']
1516,33133658,A four month squatting-based pelvic exercise regime cures day/night enuresis and bowel dysfunction in children aged 7-11 years.,"Introduction
In 2004, Patricia Skilling developed a new squatting-based pelvic floor rehabilitation method based on strengthening the three reflex pelvic muscles and ligaments hypothesized to control the closure and micturition reflexes. We adapted these methods to test our hypothesis that day/night enuresis was due to the inability of these muscles/ligaments to control an inappropriately activated micturition reflex.
Material and methods
The trial commenced as a randomized control trial to be conducted over 4 months, but was converted to a prospective trial at 4 weeks by order of the Ethics Committee. A total of 48 children, 7.6 ±2.5 years, 34 females, 14 males, had strictly supervised exercises twice daily, 10 squats, 10 bridge, fitball exercises involving proprioception exercises with surface perineal electromyogram (EMG) once a week.Eligibility criteria were daytime urine leakage plus night-time bedwetting. Exclusion criterion was refusal to sign consent forms. Assessment was done by intention to treat. The criterion for cure was complete dryness.
Results
At 1 st review (4 weeks) 12/24 in the treatment group reported total cure of wetting; 41/48 children (86%) were cured of both daytime/nighttime enuresis (p <0.001) at 4 months. There were no adverse events. Secondary outcomes were concomitant cure of constipation, fecal incontinence, urinary retention as predicted by the underlying integral theory of incontinence.
Conclusions
We believe our methods accelerated normal childhood strengthening of muscles/ligaments which control inappropriate activation of the micturition reflex which we hypothesize is the basis for daytime/nighttime enuresis. This is a simple treatment, needs diligent application and validation by others.",2020,There were no adverse events.,"['A total of 48 children, 7.6 ±2.5 years, 34 females, 14 males, had strictly supervised exercises twice daily, 10 squats, 10 bridge', 'children aged 7-11 years']",['fitball exercises involving proprioception exercises with surface perineal electromyogram (EMG'],"['concomitant cure of constipation, fecal incontinence, urinary retention as predicted by the underlying integral theory of incontinence', 'daytime urine leakage plus night-time bedwetting', 'total cure of wetting', 'cured of both daytime/nighttime enuresis']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0152245', 'cui_str': 'Extravasation of urine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0270327', 'cui_str': 'Nocturnal enuresis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162598', 'cui_str': 'Wetability'}, {'cui': 'C0014394', 'cui_str': 'Enuresis'}]",48.0,0.050999,There were no adverse events.,"[{'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Garcia-Fernandez', 'Affiliation': 'Universidad Nacional de Córdoba, Department of Pediatric Surgery, Córdoba, Argentina.'}, {'ForeName': 'Peter Emanuel', 'Initials': 'PE', 'LastName': 'Petros', 'Affiliation': ""University of NSW Professorial, Department of Surgery, St Vincent's Hospital, Sydney, Australia.""}]",Central European journal of urology,['10.5173/ceju.2020.0044']
1517,33133694,Comparing the Efficacy and Safety of Induction Therapies for the Treatment of Patients with Proliferative Lupus Nephritis in South Africa.,"Background
Lupus nephritis (LN) can be complicated with requirement for kidney replacement therapy and death. Efficacy of induction therapies using mycophenolate mofetil (MMF) or intravenous cyclophosphamide (IVCYC) has been reported from studies, but there is limited data in Africans comparing both treatments in patients with proliferative LN.
Methods
This was a retrospective study of patients with biopsy-proven proliferative LN diagnosed and treated with either MMF or IVCYC in a single centre in Cape Town, South Africa, over a 5-year period. The primary outcome was attaining complete remission after completion of induction therapy.
Results
Of the 84 patients included, mean age was 29.6 ± 10.4 years and there was a female preponderance (88.1%). At baseline, there were significant differences in estimated glomerular filtration rate (eGFR) and presence of glomerular crescents between both groups ( p ≤ 0.05). After completion of induction therapy, there was no significant difference in remission status (76.0% versus 87.5%; p =0.33) or relapse status (8.1% versus 10.3%; p =0.22) for the IVCYC and MMF groups, respectively. Mortality rate for the IVCYC group was 5.5 per 10,000 person-days of follow-up compared to 1.5 per 10,000 person-days of follow-up for the MMF group ( p =0.11), and there was no significant difference in infection-related adverse events between both groups. Estimated GFR at baseline was the only predictor of death (OR: 1.0 [0.9-1.0]; p =0.001).
Conclusion
This study shows similar outcomes following induction treatment with MMF or IVCYC in patients with biopsy-proven proliferative LN in South Africa. However, a prospective and randomized study is needed to adequately assess these outcomes.",2020,"Mortality rate for the IVCYC group was 5.5 per 10,000 person-days of follow-up compared to 1.5 per 10,000 person-days of follow-up for the MMF group ( p =0.11), and there was no significant difference in infection-related adverse events between both groups.","['patients with biopsy-proven proliferative LN in South Africa', ' mean age was 29.6\u2009±\u200910.4 years and there was a female preponderance (88.1', '84 patients included', 'patients with proliferative LN', 'Patients with Proliferative Lupus Nephritis in South Africa', 'patients with biopsy-proven proliferative LN diagnosed and treated with either MMF or IVCYC in a single centre in Cape Town, South Africa, over a 5-year period']","['mycophenolate mofetil (MMF) or intravenous cyclophosphamide (IVCYC', 'MMF or IVCYC']","['complete remission after completion of induction therapy', 'Mortality rate', 'infection-related adverse events', 'relapse status', 'estimated glomerular filtration rate (eGFR) and presence of glomerular crescents', 'remission status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0022663', 'cui_str': 'Glomerulus structure'}, {'cui': 'C0444628', 'cui_str': 'Crescents'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.0687459,"Mortality rate for the IVCYC group was 5.5 per 10,000 person-days of follow-up compared to 1.5 per 10,000 person-days of follow-up for the MMF group ( p =0.11), and there was no significant difference in infection-related adverse events between both groups.","[{'ForeName': 'Phelisa', 'Initials': 'P', 'LastName': 'Sogayise', 'Affiliation': 'Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Udeme', 'Initials': 'U', 'LastName': 'Ekrikpo', 'Affiliation': 'Department of Nephrology, University of Uyo, Uyo, Nigeria.'}, {'ForeName': 'Ayanda', 'Initials': 'A', 'LastName': 'Gcelu', 'Affiliation': 'Division of Rheumatology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Davidson', 'Affiliation': 'Kidney and Hypertension Research Unit, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Wearne', 'Affiliation': 'Kidney and Hypertension Research Unit, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Ugochi', 'Initials': 'U', 'LastName': 'Okpechi-Samuel', 'Affiliation': 'Department of Internal Medicine, Federal Medical Centre, Jabi, Abuja, Nigeria.'}, {'ForeName': 'Theophilus Ifeanyichukwu', 'Initials': 'TI', 'LastName': 'Umeizudike', 'Affiliation': 'Nephrology Unit, Department of Medicine, Lagos State University Teaching Hospital, Ikeja, Lagos, Nigeria.'}, {'ForeName': 'Innocent Ijezie', 'Initials': 'II', 'LastName': 'Chukwuonye', 'Affiliation': 'Department of Medicine, Federal Medical Centre, Umuahia, Nigeria.'}, {'ForeName': 'Ikechi', 'Initials': 'I', 'LastName': 'Okpechi', 'Affiliation': 'Kidney and Hypertension Research Unit, University of Cape Town, Cape Town, South Africa.'}]",International journal of nephrology,['10.1155/2020/2412396']
1518,33133695,Impact of Application of Multifunction Electrode (MFE) Pads on Cardiopulmonary Resuscitation Quality.,"Background
Early defibrillation and high-quality chest compressions are crucial in treatment of sudden cardiac arrest (SCA) subjects. The aim of this study was to assess an impact of defibrillation methods on cardiopulmonary resuscitation (CPR) quality.
Methods
A randomized simulation cross-study was designed, in which 100 two-person paramedical teams participated. Two 10-minute scenarios of SCA in the mechanism of ventricular fibrillation were analysed. In the first one, teams had at their disposal defibrillator with hard paddles (group C), whereas in the second one, adhesive electrodes were used (group MFE). The CPR quality was evaluated on the basis of the chest compression parameters (rate, depth, recoil, compression fraction (CCF), and no-flow time), airways patency achievement, and successful emergency drug administration.
Results
Substituting standard hard paddles with adhesive electrodes led to an increase in CCF (77% vs 73%; p < 0.05), higher rate of complete chest recoil, and a decrease in no-flow time (6.0 ± 1.1 vs. 7.3 ± 1.1; p < 0.001). The airway patency was ensured sooner in group MFE (271 ± 118 s vs. 322 ± 106 s in group C; p < 0.001). All teams in scenario with adhesive electrodes were able to administer two doses of adrenaline, meanwhile only 74% of them in group C ( p < 0.001). Moreover, in 8% of group C scenarios, paramedics did not have enough time to administer amiodarone.
Conclusion
Our simulation-based analysis revealed that use of adhesive electrodes during defibrillation instead of standard hard paddles may improve the quality of CPR performed by two-person emergency team.",2020,The airway patency was ensured sooner in group MFE (271 ± 118 s vs. 322 ± 106 s in group C; p < 0.001).,"['sudden cardiac arrest (SCA) subjects', '100 two-person paramedical teams participated']","['Multifunction Electrode (MFE) Pads', '\n\n\nEarly defibrillation and high-quality chest compressions']","['higher rate of complete chest recoil', 'cardiopulmonary resuscitation (CPR) quality', 'Cardiopulmonary Resuscitation Quality', 'airway patency', 'no-flow time', 'quality of CPR', 'CCF', 'chest compression parameters (rate, depth, recoil, compression fraction (CCF), and no-flow time), airways patency achievement, and successful emergency drug administration', 'CPR quality']","[{'cui': 'C1720824', 'cui_str': 'Cardiac Arrest, Sudden'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009081', 'cui_str': 'Talipes equinovarus'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}]",,0.0339525,The airway patency was ensured sooner in group MFE (271 ± 118 s vs. 322 ± 106 s in group C; p < 0.001).,"[{'ForeName': 'Radosław', 'Initials': 'R', 'LastName': 'Zalewski', 'Affiliation': 'Department of Medical Rescue, Chair of Emergency Medicine, Poznan University of Medical Sciences, Collegium Adama Wrzoska Rokietnicka Street 7, Poznan 60-806, Poland.'}, {'ForeName': 'Mateusz', 'Initials': 'M', 'LastName': 'Puślecki', 'Affiliation': 'Department of Medical Rescue, Chair of Emergency Medicine, Poznan University of Medical Sciences, Collegium Adama Wrzoska Rokietnicka Street 7, Poznan 60-806, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Szarpak', 'Affiliation': 'Maria Sklodowska-Curie Medical Academy in Warsaw, 12 Solidarnosci Av., 03-411 Warsaw, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Kłosiewicz', 'Affiliation': 'Department of Medical Rescue, Chair of Emergency Medicine, Poznan University of Medical Sciences, Collegium Adama Wrzoska Rokietnicka Street 7, Poznan 60-806, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Dąbrowski', 'Affiliation': 'Chair and Department of Medical Education, Poznan University of Medical Sciences, Collegium Adama Wrzoska Rokietnicka Street 7, Poznan 60-806, Poland.'}, {'ForeName': 'Bartłomiej', 'Initials': 'B', 'LastName': 'Perek', 'Affiliation': 'Department of Cardiac Surgery and Transplantology, Chair of Cardiac and Thoracic Surgery, Poznan University of Medical Sciences, Dluga Street 1/2, Poznan 61-848, Poland.'}]",Emergency medicine international,['10.1155/2020/2675214']
1519,33133739,High-Flow Nasal Cannula versus Continuous Positive Airway Pressure in Critical Bronchiolitis: A Randomized Controlled Pilot.,"We conducted a randomized controlled pilot study in infants with critical bronchiolitis ( n = 63) comparing high-flow nasal cannula (HFNC, n = 35) to continuous positive airway pressure (CPAP, n = 28). The primary outcome was treatment failure, defined as the need for bilevel positive pressure ventilation or endotracheal intubation. Treatment failure occurred in 10 patients (35.7%) in the CPAP group and 13 patients (37.1%) in the HFNC group ( p = 0.88). Pediatric intensive care unit length of stay was similar between the CPAP and HFNC groups (5 [4-7] days and 5 [4-8] days, p = 0.46, respectively). In this pilot study, treatment with HFNC resulted in a rate of treatment failure similar to CPAP.",2020,"The primary outcome was treatment failure, defined as the need for bilevel positive pressure ventilation or endotracheal intubation.","['infants with critical bronchiolitis ( n \u2009=\u200963) comparing', 'Critical Bronchiolitis']","['HFNC', 'CPAP', 'high-flow nasal cannula (HFNC, n \u2009=\u200935) to continuous positive airway pressure (CPAP, n \u2009=\u200928', 'High-Flow Nasal Cannula versus Continuous Positive Airway Pressure']","['treatment failure, defined as the need for bilevel positive pressure ventilation or endotracheal intubation', 'Pediatric intensive care unit length of stay', 'Treatment failure']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.175343,"The primary outcome was treatment failure, defined as the need for bilevel positive pressure ventilation or endotracheal intubation.","[{'ForeName': 'Regina Grigolli', 'Initials': 'RG', 'LastName': 'Cesar', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Infantil Sabará e Instituto PENSI, São Paulo, Brazil.'}, {'ForeName': 'Bibiane Ramos Pinheiro', 'Initials': 'BRP', 'LastName': 'Bispo', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Infantil Sabará e Instituto PENSI, São Paulo, Brazil.'}, {'ForeName': 'Priscilla Helena Costa Alves', 'Initials': 'PHCA', 'LastName': 'Felix', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Infantil Sabará e Instituto PENSI, São Paulo, Brazil.'}, {'ForeName': 'Maria Carolina Caparica', 'Initials': 'MCC', 'LastName': 'Modolo', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Infantil Sabará e Instituto PENSI, São Paulo, Brazil.'}, {'ForeName': 'Andreia Aparecida Freitas', 'Initials': 'AAF', 'LastName': 'Souza', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Infantil Sabará e Instituto PENSI, São Paulo, Brazil.'}, {'ForeName': 'Nelson K', 'Initials': 'NK', 'LastName': 'Horigoshi', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Infantil Sabará e Instituto PENSI, São Paulo, Brazil.'}, {'ForeName': 'Alexandre T', 'Initials': 'AT', 'LastName': 'Rotta', 'Affiliation': 'Division of Pediatric Critical Care Medicine, Duke University Medical Center, Durham, North Carolina, United States.'}]",Journal of pediatric intensive care,['10.1055/s-0040-1709656']
1520,33133740,Hyperpronation versus Supination-Flexion in Radial Head Subluxation Reduction: A Randomized Controlled Trial.,"Radial head subluxation (RHS) is the most common upper extremity injury in children. Supination-flexion (SF) and hyperpronation (HP) are two methods for reducing this subluxation. This study purposed to compare the success rates of two methods of reduction and also to determine which technique would be less painful. In total, 154 patients with RHS were enrolled in this study and randomized into two groups. Patients were to undergo reduction by one of the two methods; if the primary attempt was unsuccessful, a second attempt was performed using the alternate technique. In the case of failure of the second attempt, the first reduction technique was repeated. The success rates and pain levels before and after successful reduction were recorded. On the first attempt, 72 of 77 patients who underwent HP had a successful reduction. Four patients in the HP group had a successful reduction on the second attempt. In the SF group, 76 of 77 patients had a successful reduction on the first attempt. The success rate on first attempts was higher in the SF group than in the HP group ( p = 0.043). Pain levels before and after reduction were not statistically different between the groups ( p > 0.05). The SF technique had a higher success rate at first attempt to reduce RHS, but pain levels were similar in both methods.",2020,The success rate on first attempts was higher in the SF group than in the HP group ( p = 0.043).,"['154 patients with RHS', 'Radial Head Subluxation Reduction']","['Hyperpronation versus Supination-Flexion', 'Radial head subluxation (RHS', 'Supination-flexion (SF) and hyperpronation (HP']","['success rate on first attempts', 'success rate', 'successful reduction', 'Pain levels', 'pain levels', 'success rates and pain levels']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149977', 'cui_str': 'Pulled elbow'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0149977', 'cui_str': 'Pulled elbow'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",154.0,0.0349775,The success rate on first attempts was higher in the SF group than in the HP group ( p = 0.043).,"[{'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Porozan', 'Affiliation': 'Department of Emergency Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Forouzan', 'Affiliation': 'Department of Emergency Medicine, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Rayeheh', 'Initials': 'R', 'LastName': 'Hassanzadeh', 'Affiliation': 'Department of Emergency Medicine, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Journal of pediatric intensive care,['10.1055/s-0040-1709703']
1521,33133791,Is Prednisolone Useful in Treatment of Hyperemesis Gravidarum?,"OBJECTIVE
To compare the outcome of prednisolone versus placebo in females presenting with hyperemesis gravidarum during first trimester of pregnancy.
METHODS
Randomized controlled trial was conducted in the Department of Obstetrics & Gynecology of Jinnah Hospital, Lahore over a period of 12 months. A total of 300 patients were divided equally into two groups, i.e. prednisolone 20 mg orally 12 hourly for seven days and placebo for the same duration. Follow up in the outpatient department after one week was done to assess for continuous and/or high-frequency vomiting (as per operational definitions). Statistical Package for Social Sciences (SPSS) Statistics version 22 (IBM Corp., Armonk, NY, USA) was used to analyze data. Quantitative and qualitative variables were assessed in terms of mean/standard deviation and frequency/percentage respectively. Comparison of two study groups and stratified confounding factors (age and parity) were assessed by chi-square test (significant P-valve ≤ 0.05).
RESULTS
28.7% of cases of the prednisolone group had continuous and/or high frequency vomiting in comparison to 46% of the placebo group (p=0.002).
CONCLUSIONS
Prednisolone is effective for treating women with hyperemesis gravidarum during the first trimester of pregnancy.",2020,"28.7% of cases of the prednisolone group had continuous and/or high frequency vomiting in comparison to 46% of the placebo group (p=0.002).
","['females presenting with hyperemesis gravidarum during first trimester of pregnancy', 'Department of Obstetrics & Gynecology of Jinnah Hospital, Lahore over a period of 12 months', '300 patients']","['Prednisolone', 'placebo', 'prednisolone', 'Statistical Package for Social Sciences (SPSS']",['continuous and/or high frequency vomiting'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0020450', 'cui_str': 'Hyperemesis gravidarum'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0037434', 'cui_str': 'Social Sciences'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",300.0,0.163191,"28.7% of cases of the prednisolone group had continuous and/or high frequency vomiting in comparison to 46% of the placebo group (p=0.002).
","[{'ForeName': 'Aroosha', 'Initials': 'A', 'LastName': 'Asmat', 'Affiliation': 'Obstetrics & Gynecology, Sharif Medical & Dental College / Sharif Medical City Hospital, Lahore, PAK.'}, {'ForeName': 'Iqra', 'Initials': 'I', 'LastName': 'Yasin', 'Affiliation': 'Obstetrics & Gynecology, Sharif Medical & Dental College / Sharif Medical City Hospital, Lahore, PAK.'}, {'ForeName': 'Iffat', 'Initials': 'I', 'LastName': 'Hamid', 'Affiliation': 'Obstetrics & Gynecology, Sharif Medical & Dental College / Sharif Medical City Hospital, Lahore, PAK.'}, {'ForeName': 'Riffat', 'Initials': 'R', 'LastName': 'Nawaz', 'Affiliation': 'Obstetrics & Gynecology, Shalamar Medical & Dental College, Lahore, PAK.'}]",Cureus,['10.7759/cureus.11128']
1522,33124968,Effects of Multilayer Silicone Foam Dressings for the Prevention of Pressure Ulcers in High-Risk Patients: A Randomized Clinical Trial.,"Objective: To determine whether multilayer silicone foam dressings can prevent pressure ulcers arising in the sacrum and coccyx of patients with persistent severe diarrhea and/or fragile skin. Approach: This randomized, 14-day controlled trial included 600 hospitalized patients with persistent severe diarrhea and/or fragile skin who were at high risk of developing pressure ulcers. All participants were enrolled from three Japanese institutions. Participants meeting all inclusion and exclusion criteria were randomized using the Excel program to receive standard care (control; n = 300) recommended by Japanese guidelines or multilayer silicone foam dressings applied to the sacrum and coccyx (intervention; n = 300). Results: Significantly more participants in the control than the intervention group developed pressure ulcers (22 vs. 5, p = 0.001). Innovation: The incidence of pressure ulcers remains high in hospitalized patients at high risk of developing pressure ulcers. The present findings might contribute to novel preventive strategies for patients at high risk of developing pressure ulcers. Conclusion: Multilayer silicone foam dressings can prevent pressure ulcers of the sacrum and coccyx in patients with persistent severe diarrhea and/or fragile skin.",2020,Multilayer silicone foam dressings can prevent pressure ulcers of the sacrum and coccyx in patients with persistent severe diarrhea and/or fragile skin.,"['patients with persistent severe diarrhea and/or fragile skin', 'All participants were enrolled from three Japanese institutions', '600 hospitalized patients with persistent severe diarrhea and/or fragile skin who were at high risk of developing pressure ulcers', 'High-Risk Patients', 'patients at high risk of developing pressure ulcers', 'hospitalized patients at high risk of developing pressure ulcers', 'Participants meeting all inclusion and exclusion criteria']","['multilayer silicone foam dressings', 'Excel program to receive standard care (control; n \u2009=\u2009300) recommended by Japanese guidelines or multilayer silicone foam dressings applied to the sacrum and coccyx (intervention; n \u2009=\u2009300', 'Multilayer silicone foam dressings', 'Multilayer Silicone Foam Dressings']","['Pressure Ulcers', 'pressure ulcers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1443924', 'cui_str': 'Severe diarrhea'}, {'cui': 'C0241181', 'cui_str': 'Fragile skin'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C3164124', 'cui_str': 'Foam dressing'}, {'cui': 'C2740529', 'cui_str': 'Excel'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C0009194', 'cui_str': 'Bone structure of coccyx'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}]",600.0,0.049254,Multilayer silicone foam dressings can prevent pressure ulcers of the sacrum and coccyx in patients with persistent severe diarrhea and/or fragile skin.,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Oe', 'Affiliation': 'Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Sanae', 'Initials': 'S', 'LastName': 'Sasaki', 'Affiliation': 'Department of Nursing, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Shimura', 'Affiliation': 'Department of Nursing, Nippon Medical School Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshie', 'Initials': 'Y', 'LastName': 'Takaki', 'Affiliation': 'Department of Nursing, Fukuseikai Hospital, Fukuoka, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Sanada', 'Affiliation': 'Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}]",Advances in wound care,['10.1089/wound.2019.1002']
1523,33124985,"Comment on ""Facebook as a Novel Tool for Continuous Professional Education on Dementia: Pilot Randomized Controlled Trial"".",,2020,,[],[],[],[],[],[],,0.0744143,,"[{'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Saishoji', 'Affiliation': 'Department of General Internal Medicine, National Hospital Organization Nagasaki Medical Center, Omura, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Shiroshita', 'Affiliation': 'Department of Pulmonology, Kameda Medical Center, Kamogawa, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tsujimoto', 'Affiliation': 'Department of Nephrology and Dialysis, Kyoritsu Hospital, Kawanishi, Japan.'}]",Journal of medical Internet research,['10.2196/21505']
1524,33119435,The mnemic neglect effect and information about dementia: age differences in recall.,"Dementia represents a more immediate threat for older than for younger adults. Consequently, different strategies may be used to defend the self against the threat of dementia. We hypothesised that older (compared to younger) adults are more likely to manifest mnemic neglect (in which information that is threatening to the self is selectively forgotten) to reduce distress for dementia-related information.Fifty-nine participants aged under 50 and 44 participants aged over 50 recalled 24 dementia-related statements that were either high or low in negativity. Participants were randomised to recall statements that referred either to themselves or another person. High-negativity, self-referent statements had the most substantial threat potential. The recall of older (but not younger) participants for high-negativity (vs. low-negativity) dementia-related statements was impaired when these statements referred to the self rather than to another person. These results indicate that older adults evince mnemic neglect in response to self-threatening information about dementia.",2020,Fifty-nine participants aged under 50 and 44 participants aged over 50 recalled 24 dementia-related statements that were either high or low in negativity.,"['older (compared to younger) adults', 'Fifty-nine participants aged under 50 and 44 participants aged over 50 recalled 24 dementia-related statements that were either high or low in negativity']",[],[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",[],[],,0.0449115,Fifty-nine participants aged under 50 and 44 participants aged over 50 recalled 24 dementia-related statements that were either high or low in negativity.,"[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Cheston', 'Affiliation': 'Department of Health and Social Sciences, University of the West of England, Frenchay Campus , Bristol, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dodd', 'Affiliation': 'Department of Health and Social Sciences, University of the West of England, Frenchay Campus , Bristol, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Christopher', 'Affiliation': 'Department of Health and Social Sciences, University of the West of England, Frenchay Campus , Bristol, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wildschut', 'Affiliation': 'School of Psychology, University of Southampton , Southampton, UK.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Sedikides', 'Affiliation': 'School of Psychology, University of Southampton , Southampton, UK.'}]","Neuropsychology, development, and cognition. Section B, Aging, neuropsychology and cognition",['10.1080/13825585.2020.1842850']
1525,33120137,Does cognitive behavioural therapy or mindfulness-based therapy improve mental health and emotion regulation among men who perpetrate intimate partner violence? A randomised controlled trial.,"BACKGROUND
Intimate partner violence constitutes a serious health problem worldwide. To date the evidence is sparse on whether intimate partner violence group interventions could improve mental health outcomes among perpetrators and their partners.
OBJECTIVES
To compare the effectiveness of nurse-led cognitive-behavioural group therapy vs. mindfulness-based stress reduction group therapy in improving reported mental health outcomes and emotion regulation at 12 months' follow-up amongst perpetrators who voluntarily seek help for violence in intimate partnerships.
DESIGN
A randomised controlled trial.
PARTICIPANTS
A total of 125 persons at an outpatient service run by a University Hospital in Norway for men who perpetrate intimate partner violence were enroled in the study.
METHODS
The participants were randomly assigned to cognitive-behavioural group therapy (intervention group, N = 67) or mindfulness-based stress reduction group therapy (comparator group, N = 58). The pre-defined outcomes were symptoms of anxiety and depression as reported by the Hopkins Symptom Checklist 25 and general emotion regulation as reported by Difficulties in Emotion Regulation Scale at 12 months' follow-up.
RESULTS
A reduction of symptoms of anxiety and depression was reported, with no between-group differences (intervention group: coefficient: - 0.17, P = 0.009; comparator group: coefficient: - 0.13, P = 0.036). Both groups had a small but statistically significant reduction in the Difficulties in Emotion Regulation Scale scores at 12 months' follow-up (intervention group: coefficient: - 0.47, P = <0.001; comparator group: coefficient: - 0. 34, P = <0.001).
CONCLUSION
Even though there was reduction in symptoms in both groups at 12 months' follow-up with no between-group differences, the total symptom scores remained high in both groups.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT01653860.",2020,"Both groups had a small but statistically significant reduction in the Difficulties in Emotion Regulation Scale scores at 12 months' follow-up (intervention group: coefficient: - 0.47, P = <0.001; comparator group: coefficient: - 0.","['A total of 125 persons at an outpatient service run by a University Hospital in Norway for men who perpetrate intimate partner violence were enroled in the study', 'men who perpetrate intimate partner violence']","['nurse-led cognitive-behavioural group therapy vs. mindfulness-based stress reduction group therapy', 'cognitive behavioural therapy or mindfulness-based therapy', 'cognitive-behavioural group therapy (intervention group, N\xa0=\xa067) or mindfulness-based stress reduction group therapy (comparator group, N\xa0=\xa058']","['symptoms of anxiety and depression', 'mental health outcomes', 'symptoms of anxiety and depression as reported by the Hopkins Symptom Checklist 25 and general emotion regulation as reported by Difficulties in Emotion Regulation Scale', 'mental health and emotion regulation', 'reduction in symptoms', 'Difficulties in Emotion Regulation Scale scores', 'total symptom scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086751', 'cui_str': 'Outpatient service'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",125.0,0.0825749,"Both groups had a small but statistically significant reduction in the Difficulties in Emotion Regulation Scale scores at 12 months' follow-up (intervention group: coefficient: - 0.47, P = <0.001; comparator group: coefficient: - 0.","[{'ForeName': 'Merete Berg', 'Initials': 'MB', 'LastName': 'Nesset', 'Affiliation': ""Forensic Department and Research Centre Brøset, St. Olav's Hospital, Trondheim University Hospital, PO 1803 Lade, N-7440 Trondheim, Norway; Faculty of Medicine and Health Sciences, Department of Mental Health, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. Electronic address: merete.b.nesset@ntnu.no.""}, {'ForeName': 'Johan Håkon', 'Initials': 'JH', 'LastName': 'Bjørngaard', 'Affiliation': ""Forensic Department and Research Centre Brøset, St. Olav's Hospital, Trondheim University Hospital, PO 1803 Lade, N-7440 Trondheim, Norway; Faculty of Medicine and Health Sciences, Department of Social Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. Electronic address: Johan.H.Bjorngaard@ntnu.no.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Whittington', 'Affiliation': ""Forensic Department and Research Centre Brøset, St. Olav's Hospital, Trondheim University Hospital, PO 1803 Lade, N-7440 Trondheim, Norway; Faculty of Medicine and Health Sciences, Department of Mental Health, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. Electronic address: Richard.Whittington@ntnu.no.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Palmstierna', 'Affiliation': ""Forensic Department and Research Centre Brøset, St. Olav's Hospital, Trondheim University Hospital, PO 1803 Lade, N-7440 Trondheim, Norway; Faculty of Medicine and Health Sciences, Department of Mental Health, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. Electronic address: Tom.Palmstierna@ki.se.""}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103795']
1526,33120195,"Effect of an educational intervention delivered by pharmacists on adherence to treatment, disease control and lung function in patients with asthma.","BACKGROUND
Lack of therapeutic adherence is a relevant problem in clinical practice and it can be assessed via validated tools such as the Test of Adherence to Inhalers (TAI). Education on the correct use of inhaler devices has been associated with improvement in adherence. Many studies highlighted the pivotal role of pharmacists in promoting therapeutic adherence in the management of respiratory diseases.
OBJECTIVE
To evaluate the effectiveness on adherence and clinical parameters of an educational intervention administered by clinical pharmacists (CPs) to patients with asthma on long-term inhalation therapy.
METHODS
A prospective comparative study involving 34 community pharmacies in Italy (23 intervention, 11 control). Enrolled subjects were evaluated for adherence to inhalation therapy by TAI, asthma control by ""Asthma Control Test"" (ACT), and lung function at baseline and after 2 months. The educational intervention at baseline was based on TAI results and administered by specifically trained pharmacists.
RESULTS
A total of 242 consecutive subjects (167 intervention, 75 control) were enrolled. There was a significant improvement in TAI score, ACT and lung function parameters (p-value<0.001) in the intervention group between baseline and the follow-up visit. Patients with baseline ACT≥20 maintained disease control more frequently in the intervention group compared to the control arm (95% vs 79.5%, p = 0.004). Conclusions through administration of TAI-driven educational interventions addressing both technical and psychological issues, trained CPs can help improve adherence to treatment and asthma control.",2020,"There was a significant improvement in TAI score, ACT and lung function parameters (p-value<0.001) in the intervention group between baseline and the follow-up visit.","['242 consecutive subjects (167 intervention, 75 control) were enrolled', '34 community pharmacies in Italy (23 intervention, 11 control', 'patients with asthma on long-term inhalation therapy', 'patients with asthma']","['educational intervention administered by clinical pharmacists (CPs', 'educational intervention']","['disease control', 'TAI score, ACT and lung function parameters', 'adherence to inhalation therapy by TAI, asthma control by ""Asthma Control Test"" (ACT), and lung function']","[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021459', 'cui_str': 'Inhalation therapy procedure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1449564', 'cui_str': 'Clinical pharmacist'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0021459', 'cui_str': 'Inhalation therapy procedure'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}]",34.0,0.0251079,"There was a significant improvement in TAI score, ACT and lung function parameters (p-value<0.001) in the intervention group between baseline and the follow-up visit.","[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Paoletti', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Keber', 'Affiliation': 'Società Italiana Farmacia Clinica (SIFAC), Cagliari, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Heffler', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy. Electronic address: enrico.heffler@hunimed.eu.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Malipiero', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Baiardini', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy.'}, {'ForeName': 'Giorgio Walter', 'Initials': 'GW', 'LastName': 'Canonica', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Giua', 'Affiliation': 'Società Italiana Farmacia Clinica (SIFAC), Cagliari, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory medicine,['10.1016/j.rmed.2020.106199']
1527,33121452,Effectiveness and safety of high dose clopidogrel plus aspirin in ischemic stroke patients with the single CYP2C19 loss-of-function allele: a randomized trial.,"BACKGROUND
Dual antiplatelet aggregation therapy leads to better outcomes in patients with carotid artery stenosis, intracranial artery stenosis, minor strokes, or transient ischaemic attacks. However, carriers of the CYP2C19 loss-of-function allele may not experience the desired effects. We attempted to increase the clopidogrel dose to determine whether it would improve the outcomes of stroke patients who carry a single loss-of-function allele.
METHODS
We recruited 131 patients with minor ischaemic stroke, within less than 7 days of stroke onset and a CYP2C19 loss-of-function allele, who had moderate-to-severe cerebral artery stenosis. Patients were divided into the high dose group (clopidogrel 150 mg per day + aspirin 100 mg per day over 21 days.) and a normal dose group (clopidogrel 75 mg per day + aspirin 100 mg per day over 21 days). The reported outcomes included any vascular or major bleeding events as the primary and safety endpoints, respectively.
RESULTS
One and six vascular events occurred in the high dose and normal dose groups during the 3-months follow-up period, respectively. However, no significant difference was found between the two groups when adjusted for history of diabetes (hazard ratio, 5482; 95% confidence interval, 0.660 to 45.543; P = 0.115). No major bleeding events occurred.
CONCLUSIONS
In patients with ischaemic stroke who had a single CYP2C19 loss-of-function allele and moderate to severe cerebral stenosis, fewer vascular events occurred within 3 months with high dose of clopidogrel and aspirin than with normal dose of clopidogrel and aspirin. However, the difference between the two groups was not significant.
TRIAL REGISTRATION
Clinical study of clopidogrel in the treatment of patients with symptomatic moderate to severe cerebral artery stenosis with intermediate metabolites of CYP2C19, URL: http://www.chictr.org.cn/ . Unique identifier: ChiCTR1800017411 , 07/28/2018.",2020,"One and six vascular events occurred in the high dose and normal dose groups during the 3-months follow-up period, respectively.","['ischemic stroke patients with the single CYP2C19 loss-of-function allele', 'patients with carotid artery stenosis, intracranial artery stenosis, minor strokes, or transient ischaemic attacks', '131 patients with minor ischaemic stroke, within less than 7\u2009days of stroke onset and a CYP2C19 loss-of-function allele, who had moderate-to-severe cerebral artery stenosis', 'patients with ischaemic stroke who had a single CYP2C19 loss-of-function allele and moderate to severe cerebral stenosis', 'patients with symptomatic moderate to severe cerebral artery stenosis with intermediate metabolites of CYP2C19, URL: http://www.chictr.org.cn/ ', 'stroke patients who carry a single loss-of-function allele']","['normal dose group (clopidogrel 75\u2009mg per day + aspirin', 'clopidogrel plus aspirin', 'clopidogrel 150\u2009mg per day + aspirin', 'clopidogrel', 'clopidogrel and aspirin']","['Effectiveness and safety', 'major bleeding events', 'vascular or major bleeding events', 'history of diabetes', 'vascular events']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}, {'cui': 'C0447028', 'cui_str': 'Structure of intracranial artery'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1504438', 'cui_str': 'Cerebral artery stenosis'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1124675', 'cui_str': 'clopidogrel 75 MG'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",131.0,0.0693267,"One and six vascular events occurred in the high dose and normal dose groups during the 3-months follow-up period, respectively.","[{'ForeName': 'Hongliang', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Huiqun', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Lianwei', 'Initials': 'L', 'LastName': 'Dou', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Gao', 'Affiliation': 'Department of Radiology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Ultrasound, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Jiazhen', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Lixiang', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Chuanyu', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China.'}, {'ForeName': 'Wenzheng', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Department of Neurology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, P.R. China. chuwz2020@outlook.com.'}]",BMC neurology,['10.1186/s12883-020-01974-z']
1528,33121471,The efficacy of aspirin and metformin combination therapy in patients with rectal aberrant crypt foci: a double-blinded randomized controlled trial.,"BACKGROUND
The incidence and mortality rates of colorectal cancer (CRC) continue to increase worldwide. Therefore, new preventive strategies are needed to lower the burden of this disease. Previous studies reported that aspirin could suppress the development of sporadic colorectal adenoma. In addition, metformin is a biguanide derivative that is long widely used for the treatment of diabetes mellitus and has recently been suggested to have a suppressive effect on carcinogenesis and cancer cell growth. Both drugs exhibit a chemopreventive effect, but their efficacy is limited. Aberrant crypt foci (ACF), defined as lesions containing crypts that are larger in diameter and stain more darkly with methylene blue than normal crypts, are more prevalent in patients with cancer and adenomas, and considered a reliable surrogate biomarker of CRC. Thus, we designed a prospective trial as a preliminary study prior to a CRC chemoprevention trial to evaluate the chemopreventive effect of aspirin combined with metformin on colorectal ACF formation in patients scheduled for polypectomy.
METHODS
This study is a double-blind randomized controlled trial that will be conducted in patients with both colorectal ACF and colorectal polyps scheduled for polypectomy. Eligible patients will be recruited for the study and the number of ACF in the rectum will be counted at the baseline colonoscopy. Then, the participants will be allocated to one of the following two groups; the aspirin plus placebo group or the aspirin plus metformin group. Patients in the aspirin plus placebo group will receive oral aspirin (100 mg) and placebo for 8 weeks, and those in the aspirin plus metformin group will receive oral aspirin (100 mg) and metformin (250 mg) for 8 weeks. After 8 weeks of administration, polypectomy will be performed to evaluate changes in the number of ACF, and the cell-proliferative activity in the normal colorectal mucosa and colorectal polyps.
DISCUSSION
This is the first study proposed that will explore the effect of aspirin combined with metformin on the formation of colorectal ACF in humans.
TRIAL REGISTRATION
This trial has been registered in the University Hospital Medical Information Network (UMIN) Clinical Trials Registry as UMIN000028259 . Registered 17 July 2017.",2020,"Aberrant crypt foci (ACF), defined as lesions containing crypts that are larger in diameter and stain more darkly with methylene blue than normal crypts, are more prevalent in patients with cancer and adenomas, and considered a reliable surrogate biomarker of CRC.","['humans', 'patients with both colorectal ACF and colorectal polyps scheduled for polypectomy', 'patients with rectal aberrant crypt foci', 'Eligible patients will be recruited for the study and the number of ACF in the rectum will be counted at the baseline colonoscopy', 'patients scheduled for polypectomy', 'University Hospital Medical Information Network (UMIN']","['aspirin plus metformin', 'aspirin plus placebo', 'aspirin combined with metformin', 'oral aspirin', 'metformin', 'placebo', 'aspirin', 'aspirin and metformin combination therapy']","['colorectal ACF formation', 'sporadic colorectal adenoma', 'Aberrant crypt foci (ACF']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C1879526', 'cui_str': 'Aberrant Crypt Foci'}, {'cui': 'C0949059', 'cui_str': 'Polyp of large intestine'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021419', 'cui_str': 'Information Networks'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C1879526', 'cui_str': 'Aberrant Crypt Foci'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0205422', 'cui_str': 'Sporadic'}, {'cui': 'C1302401', 'cui_str': 'Adenoma of large intestine'}]",,0.239173,"Aberrant crypt foci (ACF), defined as lesions containing crypts that are larger in diameter and stain more darkly with methylene blue than normal crypts, are more prevalent in patients with cancer and adenomas, and considered a reliable surrogate biomarker of CRC.","[{'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Higurashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan. takuma_h@yokohama-cu.ac.jp.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Arimoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Ashikari', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Takatsu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Misawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Yoshihara', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Matsuura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Fuyuki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Ohkubo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}]",BMC cancer,['10.1186/s12885-020-07564-z']
1529,33125405,Factors influencing the bias between blood gas analysis versus central laboratory hemoglobin testing. A secondary analysis of a randomized controlled trial.,"BACKGROUND
Anemia is the most important complication during major surgery and transfusion of red blood cells is the mainstay to compensate for life threating blood loss. Therefore, accurate measurement of hemoglobin (Hb) concentration should be provided in real-time. Blood Gas Analysis (BGA) provides rapid point-of-care assessment using smaller sampling tubes compared to central laboratory (CL) services.
OBJECTIVE
This study aimed to investigate the accuracy of BGA hemoglobin testing as compared to CL services.
METHODS
Data of the ongoing LIBERAL-Trial (Liberal transfusion strategy to prevent mortality and anemia-associated ischemic events in elderly non-cardiac surgical patients, LIBERAL) was used to assess the bias for Hb level measured by BGA devices (ABL800 Flex analyzer®, GEM series® and RapidPoint 500®) and CL as the reference method. For that, we analyzed pairs of Hb level measured by CL and BGA within two hours. Furthermore, the impact of various confounding factors including age, gender, BMI, smoker status, transfusion of RBC, intraoperative hemodilution, and co-medication was elucidated. In order to ensure adequate statistical analysis, only data of participating centers providing more than 200 Hb pairs were used.
RESULTS
In total, three centers including 963 patients with 1,814 pairs of Hb measurements were analyzed. Mean bias was comparable between ABL800 Flex analyzer® and GEM series®: - 0.38 ± 0.15 g/dl whereas RapidPoint 500® showed a smaller bias (-0.09 g/dl) but greater median absolute deviation (± 0.45 g/dl). In order to avoid interference with different standard deviations caused by the different analytic devices, we focused on two centers using the same BGA technique (309 patients and 1,570 Hb pairs). A Bland-Altman analysis and LOWESS curve showed that bias decreased with smaller Hb values in absolute numbers but increased relatively. The smoker status showed the greatest reduction in bias (0.1 g/dl, p<0.001) whereas BMI (0.07 g/dl, p = 0.0178), RBC transfusion (0.06 g/dl, p<0.001), statins (0.04 g/dl, p<0.05) and beta blocker (0.03 g/dl, p = 0.02) showed a slight effect on bias. Intraoperative substitution of volume and other co-medications did not influence the bias significantly.
CONCLUSION
Many interventions like substitution of fluids, coagulating factors or RBC units rely on the accuracy of laboratory measurement devices. Although BGA Hb testing showed a consistently stable difference to CL, our data confirm that BGA devices are associated with different bias. Therefore, we suggest that hospitals assess their individual bias before implementing BGA as valid and stable supplement to CL. However, based on the finding that bias decreased with smaller Hb values, which in turn are used for transfusion decision, we expect no unnecessary or delayed RBC transfusion, and no major impact on the LIBERAL trial performance.",2020,"The smoker status showed the greatest reduction in bias (0.1 g/dl, p<0.001) whereas BMI (0.07 g/dl, p = 0.0178), RBC transfusion (0.06 g/dl, p<0.001), statins (0.04 g/dl, p<0.05) and beta blocker (0.03 g/dl, p = 0.02) showed a slight effect on bias.","['963 patients with 1,814 pairs of Hb measurements', '309 patients and 1,570 Hb pairs', 'elderly non-cardiac surgical patients, LIBERAL']",['BGA technique'],"['mortality and anemia-associated ischemic events', 'Mean bias', 'BMI', 'RBC transfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",963.0,0.0950543,"The smoker status showed the greatest reduction in bias (0.1 g/dl, p<0.001) whereas BMI (0.07 g/dl, p = 0.0178), RBC transfusion (0.06 g/dl, p<0.001), statins (0.04 g/dl, p<0.05) and beta blocker (0.03 g/dl, p = 0.02) showed a slight effect on bias.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Tanner', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Lindau', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Velten', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, University Hospital Bonn, Rheinische Friedrich-Wilhelms-University Bonn, Bonn Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schlesinger', 'Affiliation': 'Department of Anesthesiology, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wittmann', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, University Hospital Bonn, Rheinische Friedrich-Wilhelms-University Bonn, Bonn Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kranke', 'Affiliation': 'Department of Anesthesiology, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Kira', 'Initials': 'K', 'LastName': 'Berg', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Piekarski', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Füllenbach', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Suma', 'Initials': 'S', 'LastName': 'Choorapoikayil', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hasenclever', 'Affiliation': 'Institute for Medical Informatics, Statistics and Epidemiology (IMISE), Medical Faculty of the University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zacharowski', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Meybohm', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}]",PloS one,['10.1371/journal.pone.0240721']
1530,33125420,A comparison of endoscopic and microscopic inlay butterfly cartilage tympanoplasties and their educational utility.,"OBJECTIVES
Inlay butterfly cartilage tympanoplasty (IBCT) is a simple grafting technique. Endoscopy facilitates visualization by eliminating blind spots. We analyzed the outcomes of IBCT using both endoscopic and microscopic approaches, and assessed how trainees perceived the educational opportunities afforded.
MATERIALS AND METHODS
Sixty patients who underwent IBCT were allocated to Group I (n = 30; microscopic IBCT) and Group II (n = 30; endoscopic IBCT) by the dates of their visits. Anatomical success was defined as an intact, repaired tympanic membrane; functional success was defined as a significant decrease in the air-bone gap. Postoperative discomfort was analyzed using a visual analog scale (VAS). Thirteen trainees completed structured questionnaires exploring anatomical identification and the surgical steps.
RESULTS
The surgical success rates were 96.7% in Group I and 100% in Group II. We found no between-group differences in the mean decrease in the air-bone gap or the extent of postoperative discomfort. Significant postoperative hearing improvements were evident in both groups. The mean operative time was shorter when the microscopic approach was chosen (17.7±4.53 vs. 26.13±9.94 min). The two approaches significantly differed in terms of the identification of external and middle ear anatomical features by the trainees, and their understanding of the surgical steps.
CONCLUSION
Both endoscopic and microscopic IBCT were associated with good success rates. The endoscopic approach facilitates visualization, and a better understanding of the middle ear anatomy and the required surgical steps and thus is of greater educational utility.",2020,We found no between-group differences in the mean decrease in the air-bone gap or the extent of postoperative discomfort.,['Sixty patients who underwent'],"['Inlay butterfly cartilage tympanoplasty (IBCT', 'IBCT', 'endoscopic IBCT', 'microscopic IBCT']","['Significant postoperative hearing improvements', 'mean operative time', 'Postoperative discomfort', 'surgical success rates', 'visual analog scale (VAS', 'Anatomical success', 'identification of external and middle ear anatomical features']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0006496', 'cui_str': 'Butterfly'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",60.0,0.0269257,We found no between-group differences in the mean decrease in the air-bone gap or the extent of postoperative discomfort.,"[{'ForeName': 'Noor Dina', 'Initials': 'ND', 'LastName': 'Hashim', 'Affiliation': 'Department of Otorhinolaryngology, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Se A', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology, Soonchunhyang University Bucheon Hospital, Soonchunhyang University School of Medicine, Bucheon, Korea.'}, {'ForeName': 'Seung Hyun', 'Initials': 'SH', 'LastName': 'Jang', 'Affiliation': 'Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'In Seok', 'Initials': 'IS', 'LastName': 'Moon', 'Affiliation': 'Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0241152']
1531,33125448,Comparative effectiveness clinical trial of magnetic seizure therapy and electroconvulsive therapy in major depressive disorder.,"BACKGROUND
Magnetic seizure therapy (MST) has demonstrated fewer cognitive side effects than electroconvulsive therapy (ECT) in antidepressant efficacy trials. However, there are no effectiveness trials examining antidepressant efficacy and cognitive side effects against ECT. The aims of this study were to evaluate the comparative effectiveness of MST vs ECT in major depressive disorder (MDD), and compare the cognitive side effects of MST and ECT.
METHODS
In this open-label study, patients were assigned to either ECT or high-dose MST twice a week for 5 sessions based on the clinician's and the patient's decision-making. Efficacy was primarily assessed by the Hamilton Depression Rating Scale-21 (HAMD-21); cognitive side effects were assessed by time to reorientation (TRO) and cognitive battery.
RESULTS
Sixty patients were enrolled. Efficacy was similar between those assigned to MST (n = 30) and ECT (n = 30). Post-treatment HAMD-21 mean scores were 12.33 after MST, 12.80 after bitemporal (BT) ECT (n = 15), and 27.93 after right unilateral (RUL) ECT (n = 15). Magnetic seizure therapy had a significantly faster TRO of 1.8 minutes (standard deviation [SD] = 0.37) compared with ECT (RUL: 18.9 minutes [SD = 8.25]; BT: 50.2 minutes [SD = 5.89]) and had fewer cognitive side effects.
CONCLUSIONS
Magnetic seizure therapy was effective for the treatment of MDD in real-world clinical care, with fewer cognitive side effects than ECT. Future studies are warranted to replicate these findings.",2020,"Magnetic seizure therapy had a significantly faster TRO of 1.8 minutes (standard deviation [SD] = 0.37) compared with ECT (RUL: 18.9 minutes [SD = 8.25]; BT: 50.2 minutes [SD = 5.89]) and had fewer cognitive side effects.
","['major depressive disorder', 'Sixty patients were enrolled', 'major depressive disorder (MDD']","['Magnetic seizure therapy', 'ECT', 'bitemporal (BT) ECT', 'Magnetic seizure therapy (MST', 'ECT or high-dose MST', 'MST vs ECT', 'MST', 'magnetic seizure therapy and electroconvulsive therapy', 'electroconvulsive therapy (ECT']","['faster TRO', 'cognitive side effects', 'Efficacy', 'time to reorientation (TRO) and cognitive battery', 'Hamilton Depression Rating Scale-21 (HAMD-21); cognitive side effects']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0445452', 'cui_str': 'Bitemporal'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",60.0,0.0472004,"Magnetic seizure therapy had a significantly faster TRO of 1.8 minutes (standard deviation [SD] = 0.37) compared with ECT (RUL: 18.9 minutes [SD = 8.25]; BT: 50.2 minutes [SD = 5.89]) and had fewer cognitive side effects.
","[{'ForeName': 'Fatma A', 'Initials': 'FA', 'LastName': 'El-Deeb', 'Affiliation': ''}, {'ForeName': 'El-Sayed A', 'Initials': 'EA', 'LastName': 'Gad', 'Affiliation': ''}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Kandeel', 'Affiliation': ''}, {'ForeName': 'Amr A', 'Initials': 'AA', 'LastName': 'Haiba', 'Affiliation': ''}, {'ForeName': 'Sameh M', 'Initials': 'SM', 'LastName': 'Fathy', 'Affiliation': ''}, {'ForeName': 'Meghan M', 'Initials': 'MM', 'LastName': 'Peterson', 'Affiliation': ''}, {'ForeName': 'Nagy A', 'Initials': 'NA', 'LastName': 'Youssef', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University and Charlie Norwood VA Medical Center, Augusta, Georgia 30912 USA. E-MAIL: nyoussef@augusta.edu.'}]",Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists,['10.12788/acp.0005']
1532,33126095,Can counter-advertising protect spectators of elite sport against the influence of unhealthy food and beverage sponsorship? A naturalistic trial.,"RATIONALE AND OBJECTIVE
Unhealthy, energy-dense nutrient-poor foods and beverages are heavily promoted through sport sponsorship. This naturalistic trial assessed whether exposing young adult spectators to various types of counter-advertising (CA) before watching an unhealthy food sponsored elite sporting event could diminish sponsorship effects and increase support for restrictions on sponsorship.
METHOD
Young adults (ages 18-29 years) who planned to watch the Australian Football League (AFL) Grand Final were recruited through an online panel and randomly assigned to one of four conditions: (A) control (neutral advertisement); (B) anti-industry CA (critiquing unhealthy food industry sponsorship of sport); (C) anti-product CA (critiquing the association of sports stars with unhealthy food); or (D) negative health effects CA (highlighting negative health consequences of unhealthy food consumption). Participants (N = 1316) completed a pre-test questionnaire and viewed their assigned CA online 1-3 days before watching the 2017 AFL Grand Final, which featured unhealthy food sponsorship.
RESULTS
Participants who reported watching the AFL Grand Final (n = 802) answered post-test measures within five days of the event. Results indicated that participants found the anti-industry CA more believable, attention-grabbing, reassuring and encouraging than the anti-product CA. The anti-industry CA promoted less favourable attitudes to sponsor brands, the anti-product CA promoted reduced intentions to purchase the fast-food sponsor brand, and the negative health effects CA reduced preferences for fast food in general compared to the control condition.
CONCLUSIONS
Anti-industry CA may detract from favourable attitudes to unhealthy food sponsor brands and negative health effects CA may detract from intentions to consume fast food in the face of unhealthy food sponsorship exposure. Such interventions may require higher dosage levels than applied in the present study to bolster spectators' resistance to the surfeit of unhealthy food sport sponsorship.",2020,"Results indicated that participants found the anti-industry CA more believable, attention-grabbing, reassuring and encouraging than the anti-product CA.","['Young adults (ages 18-29 years) who planned to watch the Australian Football League (AFL) Grand Final were recruited through an online panel and randomly assigned to one of four conditions: (A) control (neutral advertisement', 'Participants (N\xa0=\xa01316) completed a']","['pre-test questionnaire and viewed their assigned CA online 1-3 days before watching the 2017 AFL Grand Final, which featured unhealthy food sponsorship', 'counter-advertising (CA']",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",[],,0.017522,"Results indicated that participants found the anti-industry CA more believable, attention-grabbing, reassuring and encouraging than the anti-product CA.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dixon', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia; Melbourne School of Psychological Sciences, The University of Melbourne, Parkville, Victoria, Australia; School of Psychology, Curtin University, Bentley, Western Australia, Australia. Electronic address: Helen.Dixon@cancervic.org.au.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Scully', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Wakefield', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia; Melbourne School of Psychological Sciences, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Kelly', 'Affiliation': 'Early Start, School of Health and Society, University of Wollongong, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Pettigrew', 'Affiliation': 'The George Institute for Global Health, Newtown, New South Wales, Australia; School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Chapman', 'Affiliation': 'School of Life and Environment Sciences, Faculty of Science, University of Sydney, Sydney, New South Wales, Australia; School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia; Heart Foundation, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Niederdeppe', 'Affiliation': 'Department of Communication, Cornell University, Ithaca, NY, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113415']
1533,33126096,Reducing HIV- and TB-Stigma among healthcare co-workers in South Africa: Results of a cluster randomised trial.,"RATIONALE
The HIV and TB co-epidemic has a severe impact on the South African healthcare workforce and health system. HIV- and TB- stigma directed from healthcare workers (HCWs) towards colleagues not only has a negative impact on the mental health and well-being of the HCWs, but has been identified as a barrier to their own health-seeking behaviour. It also increases the strain on the health system due to absenteeism.
OBJECTIVE
This cluster-randomised trial tested an intervention to reduce HIV- and TB-stigma among HCWs. The intervention, based on the theory of Diffusion of Innovations consisted of training healthcare workers as change agents in a Social and Behavioural Change Communication workshop to help them change stigmatising attitudes in the workplace. This was supported by a social marketing campaign.
METHODS
Eight hospitals in the Free State province were randomised into intervention and control group in a stratified study design. 652 respondents randomly drawn from the hospitals were surveyed on aspects of HIV and TB stigma once in 2016 and again in 2018. Since the study only used four hospitals per intervention arm, cluster-based summaries were compared when analysing the intervention effect, using the nonparametric Mann-Whitney test. To explore how the intervention worked, 24 qualitative focus groups were conducted following the intervention.
RESULTS
The quantitative test did not show a significant intervention effect on stigma between intervention and control groups. Qualitative evidence reported new awareness and changed behaviour related to HIV- and TB-stigma among individual HCWs, but a combination of factors including strong social hierarchies in the workplace and the down-scaling of the original version of the intervention seemed to reduce the impact. Conclusion The findings did not indicate a significant intervention effect, but show the potential of using HCWs as change agents to reduce HIV and TB stigma in their local communities.",2020,"The findings did not indicate a significant intervention effect, but show the potential of using HCWs as change agents to reduce HIV and TB stigma in their local communities.","['652 respondents randomly drawn from the hospitals were surveyed on aspects of HIV and TB stigma once in 2016 and again in 2018', 'healthcare co-workers in South Africa', 'Eight hospitals in the Free State province']",[],"['HIV and TB stigma', 'Reducing HIV- and TB-Stigma', 'HIV- and TB-stigma among HCWs']","[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1301808', 'cui_str': 'State'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",652.0,0.0411659,"The findings did not indicate a significant intervention effect, but show the potential of using HCWs as change agents to reduce HIV and TB stigma in their local communities.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Sommerland', 'Affiliation': 'Centre for Population, Family and Health, Department of Sociology, University of Antwerp, Antwerp, Belgium. Electronic address: nina.sommerland@gmail.com.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Masquillier', 'Affiliation': 'Centre for Population, Family and Health, Department of Sociology, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Asta', 'Initials': 'A', 'LastName': 'Rau', 'Affiliation': 'Centre for Health Systems Research and Development, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Engelbrecht', 'Affiliation': 'Centre for Health Systems Research and Development, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Kigozi', 'Affiliation': 'Centre for Health Systems Research and Development, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Triantafyllos', 'Initials': 'T', 'LastName': 'Pliakas', 'Affiliation': 'Centre for Evaluation, Department Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Janse van Rensburg', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Wouters', 'Affiliation': 'Centre for Population, Family and Health, Department of Sociology, University of Antwerp, Antwerp, Belgium.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113450']
1534,33126100,A qualitative exploration of mechanisms of intimate partner violence reduction for Zambian couples receiving the Common Elements Treatment Approach (CETA) intervention.,"RATIONALE
Despite well-established associations between alcohol use, poor mental health, and intimate partner violence (IPV), limited attention has been given to how psychological and behavioral interventions might prevent or treat IPV in low- and middle-income countries.
OBJECTIVE
In a recent randomized controlled trial in Lusaka, Zambia, transdiagnostic cognitive-behavioral psychotherapy (the Common Elements Treatment Approach; CETA) demonstrated significant treatment effects on men's alcohol use and women's IPV victimization in couples in which hazardous alcohol use by the male and intimate partner violence against the female was reported. In this study, we sought to gain a more in-depth understanding of mechanisms of behavior change among CETA participants.
METHODS
We conducted 50 semi-structured in-depth interviews and 4 focus groups with a purposeful sample of adult men and women who received CETA between April and October 2018. Transcripts were analyzed using an inductive constant comparison approach by a team of US- and Zambia-based coders.
RESULTS
Participants described interrelated mechanisms of change, including the use of safety strategies to not only avoid or prevent conflict but also to control anger; reductions in alcohol use that directly and indirectly reduced conflict; and, positive changes in trust and understanding of one's self and their partner. Several overarching themes also emerged from the data: how gender norms shaped participants' understanding of violence reduction strategies; the role of household economics in cycles of alcohol and violence; and, deleterious and virtuous intercouple dynamics that could perpetuate or diminish violence.
CONCLUSIONS
Results suggest important avenues for future research including the potential for combining CETA with poverty reduction or gender norms focused interventions and for incorporating cognitivebehavioral skills into community level interventions.",2020,"Several overarching themes also emerged from the data: how gender norms shaped participants' understanding of violence reduction strategies; the role of household economics in cycles of alcohol and violence; and, deleterious and virtuous intercouple dynamics that could perpetuate or diminish violence.
","['CETA participants', ""men's alcohol use and women's IPV victimization in couples in which hazardous alcohol use by the male and intimate partner violence against the female"", '50 semi-structured in-depth interviews and 4 focus groups with a purposeful sample of adult men and women who received CETA between April and October 2018', 'zambian couples receiving the Common Elements Treatment Approach (CETA) intervention']",[],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],[],,0.0260064,"Several overarching themes also emerged from the data: how gender norms shaped participants' understanding of violence reduction strategies; the role of household economics in cycles of alcohol and violence; and, deleterious and virtuous intercouple dynamics that could perpetuate or diminish violence.
","[{'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA. Electronic address: Sarah.murray@jhu.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Skavenski Van Wyk', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Metz', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Saphira Munthali', 'Initials': 'SM', 'LastName': 'Mulemba', 'Affiliation': 'Serenity Harm Reduction Programme Zambia (SHARPZ), USA.'}, {'ForeName': 'Mwamba M', 'Initials': 'MM', 'LastName': 'Mwenge', 'Affiliation': 'Serenity Harm Reduction Programme Zambia (SHARPZ), USA.'}, {'ForeName': 'Jeremy C', 'Initials': 'JC', 'LastName': 'Kane', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Alto', 'Affiliation': 'University of Rochester, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Venturo-Conerly', 'Affiliation': 'Department of Psychology, Harvard University, USA.'}, {'ForeName': 'Akash R', 'Initials': 'AR', 'LastName': 'Wasil', 'Affiliation': 'Department of Psychology, Harvard University, USA.'}, {'ForeName': 'Shoshanna L', 'Initials': 'SL', 'LastName': 'Fine', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113458']
1535,33126310,"Efficacy of DA-5204 (Stillen 2X) for patients with gastroesophageal reflux disease: A randomized, double-blind, placebo-controlled pilot study.","BACKGROUND/AIM
Proton pump inhibitor (PPI) alone is not satisfactory for the treatment of gastroesophageal reflux disease (GERD). Therefore, we investigated the efficacy of DA-5204 (Stillen 2X, 90 mg of Artemisia asiatica 95% ethanol extract per tablet) and PPI combination therapy on GERD in comparison to PPI alone.
METHODS
This randomized, double-blind, placebo-controlled study randomly assigned 70 patients with endoscopically proven esophageal mucosal injury (Los Angeles classification grade A or B) into 2 groups: pantoprazole 40 mg once daily with DA-5204 twice daily (DA-5204 group) or pantoprazole 40 mg once daily with placebo twice daily (placebo group) for 4 weeks. The primary endpoint was endoscopic healing rate. The secondary endpoint was sufficient relief (≥50% reduction) of symptoms using GERD Questionnaire.
RESULTS
Final analyses included 29 patients with the DA-5204 group and 30 patients with the placebo group. At weeks 4, there was no significant difference in the endoscopic healing rate between the 2 groups (DA-5204 vs placebo; 96.6% vs 93.3%; P = 1.000). However, the rate of residual minimal change was significantly lower in the DA-5204 group (5/28, 17.9%) than in the placebo group (17/28, 60.7%) (P < .001). The rates of symptom relief were not different between the DA-5204 group and the placebo group (all P > .05).
CONCLUSION
Combined therapy with PPI and DA-5204 has no additional effect on the endoscopic healing rate compared to PPI alone. However, it may be beneficial in resolving minimal change.",2020,DA-5204 vs placebo; 96.6% vs 93.3%; P = 1.000).,"['gastroesophageal reflux disease (GERD', '70 patients with endoscopically proven esophageal mucosal injury (Los Angeles classification grade A or B) into 2 groups', '29 patients with the DA-5204 group and 30 patients with the placebo group', 'patients with gastroesophageal reflux disease']","['Proton pump inhibitor (PPI) alone', 'DA-5204 (Stillen 2X', 'DA-5204 (Stillen 2X, 90\u200amg of Artemisia asiatica 95% ethanol extract per tablet) and PPI combination therapy', 'pantoprazole 40\u200amg once daily with DA-5204 twice daily (DA-5204 group) or pantoprazole 40\u200amg once daily with placebo twice daily (placebo', 'DA-5204 vs placebo', 'placebo']","['endoscopic healing rate', 'rates of symptom relief', 'sufficient relief', 'rate of residual minimal change']","[{'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4279632', 'cui_str': 'Stillen'}, {'cui': 'C0331308', 'cui_str': 'Artemisia'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C1126048', 'cui_str': 'pantoprazole 40 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",70.0,0.318746,DA-5204 vs placebo; 96.6% vs 93.3%; P = 1.000).,"[{'ForeName': 'Jae Ho', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Hyuk', 'Initials': 'H', 'LastName': 'Yoon', 'Affiliation': ''}, {'ForeName': 'Cheol Min', 'Initials': 'CM', 'LastName': 'Shin', 'Affiliation': ''}, {'ForeName': 'Young Soo', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022729']
1536,33126931,A public health approach to increase treatment of latent TB among household contacts in Brazil.,"SETTING: Two consecutive trials were conducted to evaluate the effectiveness of a public health approach to identify and correct problems in the care cascade for household contacts (HHCs) of TB patients in three Brazilian high TB incidence cities. METHODS: In the first trial, 12 clinics underwent standardised evaluation using questionnaires administered to TB patients, HHCs and healthcare workers, and analysis of the cascade of latent TB care among HHCs. Six clinics were then randomised to receive interventions to strengthen management of latent TB infection (LTBI), including in-service training provided by nurses, work process organisation and additional clinic-specific solutions. In the second trial, a similar but streamlined evaluation was conducted in two clinics, who then received initial and subsequent intensive in-service training provided by a physician. RESULTS: In the evaluation phase of both trials, many HHCs were identified, but few started LTBI treatment. After the intervention, the number of HHCs initiating treatment per 100 active TB patients increased by 10 (95%CI - 11 to 30) in the first trial, and by 44 (95%CI 26 to 61) in the second trial. DISCUSSION: A public health approach with standardised evaluation, local decisions for improvements, followed by intensive initial and in-service training appears promising for improved LTBI management.",2020,"After the intervention, the number of HHCs initiating treatment per 100 active TB patients increased by 10 (95%CI - 11 to 30) in the first trial, and by 44 (95%CI 26 to 61) in the second trial.","['TB patients in three Brazilian high TB incidence cities', 'latent TB among household contacts in Brazil']","['public health approach', 'interventions to strengthen management of latent TB infection (LTBI), including in-service training provided by nurses, work process organisation and additional clinic-specific solutions']",['number of HHCs initiating treatment'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1609538', 'cui_str': 'Inactive tuberculosis'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1609538', 'cui_str': 'Inactive tuberculosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1833213', 'cui_str': 'Hyperferritinemia cataract syndrome'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",12.0,0.081285,"After the intervention, the number of HHCs initiating treatment per 100 active TB patients increased by 10 (95%CI - 11 to 30) in the first trial, and by 44 (95%CI 26 to 61) in the second trial.","[{'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Bastos', 'Affiliation': 'Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil, Respiratory Epidemiology & Clinical Research Unit.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Oxlade', 'Affiliation': 'McGill International TB Centre.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Respiratory Epidemiology & Clinical Research Unit, Departments of Epidemiology, Biostatistics & Occupational Health, and Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Fregonese', 'Affiliation': 'Respiratory Epidemiology & Clinical Research Unit.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Valiquette', 'Affiliation': 'Respiratory Epidemiology & Clinical Research Unit.'}, {'ForeName': 'S C C', 'Initials': 'SCC', 'LastName': 'Lira', 'Affiliation': 'Recife Municipal Health Secretariat, Recife, PE, Programa de Pós-graduação em Saúde Coletiva, Universidade Federal do Pernambuco, Recife, PE.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Carvalho-Cordeiro', 'Affiliation': 'Manaus Municipal Health Secretariat, Manaus, AM, Programa de Pós-gradução em Enfermagem, Universidade Federal do Amazonas, Manaus, AM.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Cavalcante', 'Affiliation': 'Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Faerstein', 'Affiliation': 'Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'M F M', 'Initials': 'MFM', 'LastName': 'Albuquerque', 'Affiliation': 'Aggeu Magalhães Research Center, Fiocruz, Recife, PE.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cordeiro-Santos', 'Affiliation': 'Tropical Medicine Post-Graduation Program, Amazonas State University, Manaus, AM, Tropical Medicine Foundation Dr Heitor Vieira Dourado, Manaus, AM, Brazil.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Hill', 'Affiliation': 'Centre for International Health, Otago Medical School, University of Otago, Otago, New Zealand.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Menzies', 'Affiliation': 'Respiratory Epidemiology & Clinical Research Unit, McGill International TB Centre, Departments of Epidemiology, Biostatistics & Occupational Health, and Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Trajman', 'Affiliation': 'McGill International TB Centre, Internal Medicine Post-Graduation Program, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Primary Health Care Post-Graduation Program, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}]",The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease,['10.5588/ijtld.19.0728']
1537,33127015,Cost-Effectiveness of Immediate Magnetic Resonance Imaging In the Management of Patients With Suspected Scaphoid Fracture: Results From a Randomized Clinical Trial.,"OBJECTIVES
Given the limited diagnostic accuracy of radiographs on presentation to the emergency department (ED), the management of suspected scaphoid fractures remains clinically challenging and poses an unknown economic burden to healthcare systems. We aimed to evaluate the cost-effectiveness of immediate magnetic resonance imaging (MRI) in the management of patients presenting with suspected scaphoid fracture to an ED in England.
METHODS
A pragmatic, randomized, single-center trial compared the use of immediate MRI in the ED against standard care with radiographs only. Participants' use of healthcare services and costs were estimated from primary care and secondary care databases and questionnaires at baseline, 1, 3, and 6 months postrecruitment. Costs were compared using generalized linear models and combined with quality-adjusted life years (QALYs, based on the EQ-5D-5L) to estimate cost-effectiveness at 6 months postrecruitment. Cost-effectiveness acceptability curves and bootstrapping techniques were used to estimate the probability of cost-effectiveness at different willingness-to-pay (WTP) thresholds. Four deterministic sensitivity scenarios were considered around key parameters.
RESULTS
The MRI intervention dominated standard care in the base case and all 4 deterministic sensitivity scenarios, costing less and achieving more QALY gains, with a probability of 100% of being cost-effective at 6 months using the conventional United Kingdom WTP thresholds of £20 000 to £30 000 per QALY.
CONCLUSION
The use of immediate MRI is a cost-effective intervention in the management of suspected scaphoid fractures in a Central Hospital in London. Routine clinical practice at our institution has been changed to include the intervention.",2020,The use of immediate MRI is a cost-effective intervention in the management of suspected scaphoid fractures in a Central Hospital in London.,"['suspected scaphoid fractures in a Central Hospital in London', 'Patients With Suspected Scaphoid Fracture', 'patients presenting with suspected scaphoid fracture to an ED in England']","['Immediate Magnetic Resonance Imaging', 'immediate MRI', 'immediate magnetic resonance imaging (MRI']","['cost-effectiveness', 'probability of cost-effectiveness']","[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0272654', 'cui_str': 'Fracture of scaphoid bone of wrist'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.0872574,The use of immediate MRI is a cost-effective intervention in the management of suspected scaphoid fractures in a Central Hospital in London.,"[{'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Rua', 'Affiliation': ""King's Health Economics, King's College London, London, England, UK; Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, England, UK. Electronic address: tiago.rua@kcl.ac.uk.""}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Gidwani', 'Affiliation': ""Department of Orthopaedics, Guy's and St Thomas' NHS Foundation Trust, London, England, UK.""}, {'ForeName': 'Bharti', 'Initials': 'B', 'LastName': 'Malhotra', 'Affiliation': ""Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, England, UK.""}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Vijayanathan', 'Affiliation': ""Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, England, UK.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hunter', 'Affiliation': ""Emergency Department, Guy's and St Thomas' NHS Foundation Trust, London, England, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Peacock', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, England, UK.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Turville', 'Affiliation': ""Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, England, UK.""}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Razavi', 'Affiliation': ""Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, England, UK; Vice President & Vice-Principal (Research), King's College London, London, England, UK.""}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Goh', 'Affiliation': ""Department of Radiology, Guy's and St Thomas' NHS Foundation Trust, London, England, UK; Cancer Imaging, School of Biomedical Engineering and Imaging Sciences, King's College London, London, England, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""King's Health Economics, King's College London, London, England, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shearer', 'Affiliation': ""King's Health Economics, King's College London, London, England, UK.""}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.05.020']
1538,33134144,Comparison of Sedation with Dexmedetomidine Alfentanil Versus Ketamine-Alfentanil in Patients Undergoing Closed Reduction of Nasal Fractures.,"Objectives
To compare the sedative effects of dexmedetomidine alfentanil versus ketamine-alfentanil in patients undergoing closed reduction of nasal fractures on the basis of intraoperative hemodynamic changes, satisfaction of patients and surgeons, and the adverse effects.
Methods
Sixty patients with ASA class 1 or 2 were randomized to either of two groups, a dexmedetomidine alfentanil group (DA group; n = 30) or a ketamine-alfentanil group (KA group; n = 30). Hemodynamic parameters, oxygenation status, adverse events, the satisfaction of patients and surgeons, and postoperative pain scores by visual analog scale (VAS) were recorded at specific time intervals during the trial.
Results
Systolic blood pressure was significantly lower in the DA group than in the KA group from T1 min to T15 min. The duration of the recovery ward stay was longer in the DA group; however, two groups were similar in terms of total anesthesia time and awakening time. Likewise, two groups were similar in terms of the patient and surgeon's satisfaction, pain scores, and the occurrence of adverse effects.
Conclusions
Both sedation methods were safely performed, and dexmedetomidine-alfentanil is as effective as ketamine-alfentanil in patients undergoing short-term operations such as nasal fracture corrections.",2020,"Results
Systolic blood pressure was significantly lower in the DA group than in the KA group from T1 min to T15 min.","['Sixty patients with ASA class 1 or 2', 'patients undergoing closed reduction of nasal fractures', 'Patients Undergoing Closed Reduction of Nasal Fractures', 'patients undergoing short-term operations such as nasal fracture corrections']","['dexmedetomidine alfentanil', 'ketamine-alfentanil', 'Dexmedetomidine Alfentanil Versus Ketamine-Alfentanil', 'dexmedetomidine-alfentanil']","['duration of the recovery ward stay', 'Hemodynamic parameters, oxygenation status, adverse events, the satisfaction of patients and surgeons, and postoperative pain scores by visual analog scale (VAS', 'total anesthesia time and awakening time', ""patient and surgeon's satisfaction, pain scores, and the occurrence of adverse effects"", 'Systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0189090', 'cui_str': 'Closed reduction of nasal fracture'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0339848', 'cui_str': 'Fractured nasal bones'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",60.0,0.0469398,"Results
Systolic blood pressure was significantly lower in the DA group than in the KA group from T1 min to T15 min.","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Akhondzadeh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Olapour', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mahboobe', 'Initials': 'M', 'LastName': 'Rashidi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Elyasinia', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Anesthesiology and pain medicine,['10.5812/aapm.102946']
1539,33134147,Comparison of the Combined Femoral and Lateral Femoral Cutaneous Nerve Block Plus Popliteal Block with Spinal Anesthesia for Thigh Tourniquet Pain During Foot or Ankle Surgery: A Randomized Clinical Trial.,"Background
A pneumatic thigh tourniquet is routinely used during lower-extremity orthopedic surgeries to provide a bloodless field. When using peripheral nerve blocks, tourniquet-related thigh pain and discomfort limit their routine use as an anesthetic method.
Objectives
The aim of the present prospective, randomized study was to compare the efficacy of combined femoral nerve/lateral femoral cutaneous nerve block technique and spinal anesthesia on intraoperative thigh tourniquet pain.
Methods
We studied 60 American Society of Anesthesiologists physical status I-II patients scheduled for orthopedic surgery on the foot or ankle using a pneumatic thigh tourniquet. They were randomly divided into two equal groups. The peripheral nerve block group received a combined popliteal, femoral, and lateral femoral cutaneous nerve block under ultrasound-guidance. In both groups, the level of sensory blockade was determined by the pinprick test. The block performance time, anesthetic effect time, intraoperative tourniquet pain scores, the amount of fentanyl and ketamine, surgery duration, and patient's satisfaction were recorded.
Results
The patients' characteristics were comparable in the two groups. The mean duration of block performance and anesthetic effect, intraoperative tourniquet pain scores, and the amount of intravenous analgesics in the peripheral nerve block group were significantly greater than those in the spinal anesthesia group. Patient satisfaction was similar in both groups.
Conclusions
Spinal anesthesia is significantly more effective than the peripheral nerve block method in reducing thigh tourniquet pain. A combined femoral and lateral femoral cutaneous nerve block with popliteal block can improve thigh tourniquet tolerance if supplemented with intravenous analgesics.",2020,"The mean duration of block performance and anesthetic effect, intraoperative tourniquet pain scores, and the amount of intravenous analgesics in the peripheral nerve block group were significantly greater than those in the spinal anesthesia group.",['60 American Society of Anesthesiologists physical status I-II patients scheduled for orthopedic surgery on the foot or ankle using a pneumatic thigh tourniquet'],"['Combined Femoral and Lateral Femoral Cutaneous Nerve Block Plus Popliteal Block with Spinal Anesthesia', 'combined femoral nerve/lateral femoral cutaneous nerve block technique and spinal anesthesia', 'combined popliteal, femoral, and lateral femoral cutaneous nerve block under ultrasound-guidance', '\n\n\nA pneumatic thigh tourniquet']","['Patient satisfaction', 'mean duration of block performance and anesthetic effect, intraoperative tourniquet pain scores, and the amount of intravenous analgesics', ""block performance time, anesthetic effect time, intraoperative tourniquet pain scores, the amount of fentanyl and ketamine, surgery duration, and patient's satisfaction"", 'level of sensory blockade', 'thigh tourniquet tolerance', 'Thigh Tourniquet Pain', 'thigh tourniquet pain']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0394740', 'cui_str': 'Local anesthetic lateral femoral cutaneous nerve block'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0015808', 'cui_str': 'Structure of femoral nerve'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C3179301', 'cui_str': 'Anesthetic Effects'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.122257,"The mean duration of block performance and anesthetic effect, intraoperative tourniquet pain scores, and the amount of intravenous analgesics in the peripheral nerve block group were significantly greater than those in the spinal anesthesia group.","[{'ForeName': 'Shideh', 'Initials': 'S', 'LastName': 'Dabir', 'Affiliation': 'Department of Anesthesiology and Critical Care, Tracheal Diseases Research Center, Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Mosaffa', 'Affiliation': 'Department of Anesthesiology, Anesthesiology Research Center, Akhtar Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Hosseini', 'Affiliation': 'Department of Anesthesiology, Anesthesiology Research Center, Akhtar Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Alimoradi', 'Affiliation': 'Department of Anesthesiology and Critical Care, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Anesthesiology and pain medicine,['10.5812/aapm.103674']
1540,33134152,Intrathecal Morphine Is Associated with Less Delirium Following Hip Fracture Surgery: A Register Study.,"Background
Delirium is a common complication after proximal femoral fracture surgery, with pain and opioid consumption as the contributing factors. The administration of intrathecal morphine may decrease these factors postoperatively and potentially reduce delirium.
Objectives
This research aimed to study the association between the use of intrathecal morphine and the occurrence of delirium.
Methods
A retrospective analysis of a prospective register kept in a non-academic hospital in the Netherlands was performed. The register contained data of all patients with proximal femur fractures that were surgically treated with osteosynthesis or prosthesis. Patients receiving spinal anesthesia (SA group) were compared with patients receiving spinal anesthesia with the addition of intrathecal morphine (SIM group). The administration of either SA or SIM was based on the preference of the anesthesiologist. The primary outcome was the incidence of delirium, as defined by the DSM-V classification. The follow-up lasted until hospital discharge. Both univariate and multivariate analyses were performed.
Results
The SA group consisted of 451 patients, and the SIM group included 34 patients. Delirium occurred in 19.7% in the SA group versus 5.9% in the SIM group (P = 0.046). This association remained significant after correction in multivariate analysis (OR of delirium in the SA group, 95% CI: 1.062 - 21.006, P = 0.041). Additionally, multivariate analysis revealed that age, gender, preoperative cognitive impairment, and fracture treatment (osteosynthesis or prosthesis) were independently associated with delirium.
Conclusions
This retrospective study found an independent association between the use of intrathecal morphine and a lower incidence of delirium. This clinically relevant decrease in delirium should be studied in a prospective randomized study.",2020,Delirium occurred in 19.7% in the SA group versus 5.9% in the SIM group (P = 0.046).,['patients with proximal femur fractures that were surgically treated with'],"['spinal anesthesia with the addition of intrathecal morphine', 'osteosynthesis or prosthesis', 'intrathecal morphine', 'Hip Fracture Surgery', 'spinal anesthesia', 'Intrathecal Morphine', 'SA or SIM']","['preoperative cognitive impairment, and fracture treatment (osteosynthesis or prosthesis', 'incidence of delirium, as defined by the DSM-V classification', 'Delirium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0919720', 'cui_str': 'Fracture treatment'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]",451.0,0.09605,Delirium occurred in 19.7% in the SA group versus 5.9% in the SIM group (P = 0.046).,"[{'ForeName': 'Mark Vincent', 'Initials': 'MV', 'LastName': 'Koning', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'van der Sijp', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, LUMC-Campus the Hague, Leiden, The Netherlands.'}, {'ForeName': 'Robert Jan', 'Initials': 'RJ', 'LastName': 'Stolker', 'Affiliation': 'Department of Anesthesiology, Erasmus Univerity Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Niggebrugge', 'Affiliation': 'Department of Surgery, Haaglanden Medical Center, The Hague, The Netherlands.'}]",Anesthesiology and pain medicine,['10.5812/aapm.106076']
1541,33134176,Longitudinal Trend of Health-Related Quality of Life During Concurrent Chemoradiotherapy and Survival in Patients With Stage II-IVb Nasopharyngeal Carcinoma.,"Background and Aims: To investigate the longitudinal trend of health-related quality of life (HRQOL) from the start to the end of concurrent chemoradiotherapy and survival in patients with advanced nasopharyngeal carcinoma (NPC). Methods: A total of 145 patients with stage II-IVb NPC, who were a subsample of a randomized phase III clinical trial, were recruited in this study. HRQOL was measured weekly for a total of 6 weeks during concurrent chemoradiotherapy by the Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30. Longitudinal trends of HRQOL domains over time were analyzed using mixed models. Survival rates were estimated using Kaplan-Meier method. Results: During a median follow-up of 45 months, the 3-year progression-free survival rate, overall survival rate, and distant metastasis-free survival rate were highly at 86.8% (95% CI: 80.1%, 91.4%), 95.1% (95% CI: 90.1%, 97.6%), and 91.0% (95% CI: 84.9%, 94.6%), respectively. The average weekly declines of five functioning domains were 1.83-3.52 points during the treatment period, with role functioning having the largest decline rate (-2.52 points per week, 95% CI: -4.50, -2.55; p < 0.001). Loss of appetite is the most affected symptom, with severe appetite loss ranging from 35.9 to 61.1%. The average increases of symptoms were 0.63-5.16 points per week during treatment period (all p -values for time <0.001, except for financial difficulties), with pain symptoms having the largest increase (5.16 points, 95%CI: 4.25, 6.08; p < 0.001), followed by fatigue (3.62 points, 95%CI: 2.90, 4.35; p < 0.001). Conclusion: The HRQOL of patients with advanced NPC is poor and substantially deteriorated during the concurrent chemoradiotherapy (CCRT) period. Psychological care and support is necessary for patients with advanced NPC during the treatment period.",2020,"During a median follow-up of 45 months, the 3-year progression-free survival rate, overall survival rate, and distant metastasis-free survival rate were highly at 86.8% (95% CI: 80.1%, 91.4%), 95.1% (95% CI: 90.1%, 97.6%), and 91.0% (95% CI: 84.9%, 94.6%), respectively.","['145 patients with stage II-IVb NPC, who were a subsample of a randomized phase III clinical trial', 'patients with advanced NPC during the treatment period', 'patients with advanced nasopharyngeal carcinoma (NPC', 'Patients With Stage II-IVb Nasopharyngeal Carcinoma']",[],"['HRQOL', 'pain symptoms', 'Health-Related Quality of Life', '3-year progression-free survival rate, overall survival rate, and distant metastasis-free survival rate', 'health-related quality of life (HRQOL', 'Survival rates']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0028587', 'cui_str': 'Nuclear Pore'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}]",[],"[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",145.0,0.318362,"During a median follow-up of 45 months, the 3-year progression-free survival rate, overall survival rate, and distant metastasis-free survival rate were highly at 86.8% (95% CI: 80.1%, 91.4%), 95.1% (95% CI: 90.1%, 97.6%), and 91.0% (95% CI: 84.9%, 94.6%), respectively.","[{'ForeName': 'Ji-Bin', 'Initials': 'JB', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Research, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Shan-Shan', 'Initials': 'SS', 'LastName': 'Guo', 'Affiliation': 'State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Lin-Quan', 'Initials': 'LQ', 'LastName': 'Tang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Hao-Yuan', 'Initials': 'HY', 'LastName': 'Mo', 'Affiliation': 'State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Qiu-Yan', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Hai-Qiang', 'Initials': 'HQ', 'LastName': 'Mai', 'Affiliation': 'State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.579292']
1542,33134594,Comparison of the Effects of Native Vitamin D and Eldecalcitol on Muscular Strength and Dynamic Balance in Patients with Postmenopausal Osteoporosis.,"Objectives
Previous studies have suggested that the effects of vitamin D in preventing osteoporotic fractures result in part from its influence on fall prevention. However, the effects of vitamin D on dynamic balance as a contributor to fall prevention have not been fully evaluated. Moreover, few studies have compared the effects of native and active forms of vitamin D. The objective of this preliminary randomized prospective study was to compare the effects of native vitamin D and eldecalcitol on muscular strength and dynamic balance in postmenopausal patients undergoing denosumab treatment for osteoporosis.
Methods
A total of 30 women with postmenopausal osteoporosis were randomly assigned to a native D group (administered denosumab and native vitamin D with calcium) or an ELD group (administered denosumab and eldecalcitol) and were followed up for 6 months. The following parameters were compared: the strengths of the back extensor and lower extremity muscles; static balance evaluated using the one-leg standing test; and dynamic balance evaluated using the 10-m walk test, the functional reach test, the timed up and go test, and the total length of the trajectory of the center of gravity (LNG) measured using a dynamic sitting balance measurement device.
Results
Compared to baseline measurements, back extensor and knee extensor strengths had significantly increased after 6 months of treatment in the native D group (P<0.05) but not in the ELD group. In contrast, LNG significantly improved in both groups after 6 months (P<0.05). No significant differences between the two groups were seen in any of these measured parameters after treatment.
Conclusions
Both native vitamin D + denosumab and eldecalcitol + denosumab were effective for improving dynamic sitting balance in postmenopausal women with osteoporosis.",2020,"Compared to baseline measurements, back extensor and knee extensor strengths had significantly increased after 6 months of treatment in the native D group (P<0.05) but not in the ELD group.","['postmenopausal patients undergoing denosumab treatment for osteoporosis', '30 women with postmenopausal osteoporosis', 'Patients with Postmenopausal Osteoporosis', 'postmenopausal women with osteoporosis']","['vitamin D', 'native vitamin D and eldecalcitol', 'ELD group (administered denosumab and eldecalcitol', 'Native Vitamin D and Eldecalcitol', 'native vitamin D + denosumab and eldecalcitol + denosumab', 'native D group (administered denosumab and native vitamin D with calcium']","['muscular strength and dynamic balance', 'osteoporotic fractures', 'dynamic sitting balance', 'back extensor and knee extensor strengths', 'Muscular Strength and Dynamic Balance', 'strengths of the back extensor and lower extremity muscles; static balance evaluated using the one-leg standing test; and dynamic balance evaluated using the 10-m walk test, the functional reach test, the timed up and go test, and the total length of the trajectory of the center of gravity (LNG) measured using a dynamic sitting balance measurement device']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4303745', 'cui_str': 'Treatment for osteoporosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C2828245', 'cui_str': 'eldecalcitol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0516712', 'cui_str': 'Balancing when sitting'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",30.0,0.0265946,"Compared to baseline measurements, back extensor and knee extensor strengths had significantly increased after 6 months of treatment in the native D group (P<0.05) but not in the ELD group.","[{'ForeName': 'Naohisa', 'Initials': 'N', 'LastName': 'Miyakoshi', 'Affiliation': 'Department of Orthopedic Surgery, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Norimitsu', 'Initials': 'N', 'LastName': 'Masutani', 'Affiliation': 'Department of Orthopedic Surgery, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Kasukawa', 'Affiliation': 'Department of Orthopedic Surgery, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kudo', 'Affiliation': 'Department of Orthopedic Surgery, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Kimio', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'Department of Orthopedic Surgery, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Matsunaga', 'Affiliation': 'Department of Orthopedic Surgery, Akita University Graduate School of Medicine, Akita, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': 'Department of Orthopedic Surgery, Akita University Graduate School of Medicine, Akita, Japan.'}]",Progress in rehabilitation medicine,['10.2490/prm.20200026']
1543,33134600,Botulinum Toxin Injection for Analgesic Effect after Hemorrhoidectomy: A Randomized Control Trial.,"Objectives
Hemorrhoid is a common disease in surgical practice, but only a few numbers of patients need surgical treatment. The most common concern of patients is postoperative pain. This study aimed to evaluate the efficacy and safety of an intersphincteric injection of botulinum toxin for post-hemorrhoidectomy pain relief.
Methods
Overall, 90 patients were enrolled, and 44 were randomized into a botulinum toxin injection group. Preoperative gradings were grade III 37 patients and grade II 2 patients. Patients received an intersphincteric injection of 0.5 ml of a solution containing 30 units of botulinum toxin (BTX). The postoperative data were collected pain score in a visual analog score (VAS), an analgesic used, hospital stay, and complication.
Results
The VAS was lower in the BTX group at 12 hours and 24 hours postoperative phase. VAS at 12 hours 4.435 ± 2.149 vs 6.232 ± 2.307 (p < 0.001), VAS at 24 hours 2.205 ± 2.079 vs 3.744 ± 2.361(p = 0.003). The BTX group has a shorter time in defection without pain than the control group (3 vs. two days, p = 0.007). There was no difference in immediate and delay complications between the two groups.
Conclusions
Postoperative hemorrhoidectomy needs multimodalities for pain reduction. Botulinum toxin has some benefit in postoperative pain reduction.",2020,"VAS at 12 hours 4.435 ± 2.149 vs 6.232 ± 2.307 (p < 0.001), VAS at 24 hours 2.205 ± 2.079 vs 3.744 ± 2.361(p = 0.003).","['90 patients were enrolled, and 44']","['botulinum toxin injection', 'Botulinum toxin', 'intersphincteric injection of botulinum toxin', 'Hemorrhoidectomy', 'Botulinum Toxin Injection', 'BTX', 'intersphincteric injection of 0.5 ml of a solution containing 30 units of botulinum toxin (BTX']","['immediate and delay complications', 'efficacy and safety', 'VAS', 'shorter time in defection without pain', 'collected pain score in a visual analog score (VAS), an analgesic used, hospital stay, and complication', 'postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",90.0,0.126786,"VAS at 12 hours 4.435 ± 2.149 vs 6.232 ± 2.307 (p < 0.001), VAS at 24 hours 2.205 ± 2.079 vs 3.744 ± 2.361(p = 0.003).","[{'ForeName': 'Siripong', 'Initials': 'S', 'LastName': 'Sirikurnpiboon', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Rajavithi Hospital, College of Medicine, Rangsit University, Bangkok, Thailand.'}, {'ForeName': 'Paiboon', 'Initials': 'P', 'LastName': 'Jivapaisarnpong', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Rajavithi Hospital, College of Medicine, Rangsit University, Bangkok, Thailand.'}]","Journal of the anus, rectum and colon",['10.23922/jarc.2020-027']
1544,33134603,Are published randomized clinical trials abstracts on periodontics reported adequately?,"Introduction
Randomized clinical trials (RCTs) remain the golden standard in biomedical research, which makes their reporting to a high quality essential to control RCTs' internal validity. The purpose of this study was to evaluate the quality of abstract reporting of RCTs published in periodontic journals and their compliance with the CONSORT guidelines.
Methods
A hand search was undertaken to identify RCTs published in three periodontic journals [1] Journal of periodontology (JOP) [2], the Journal of periodontal research (JOPR) and [3] the Journal of clinical periodontology (JOCP) from 2015 to 2018.The completeness of abstract reporting was evaluated with a modified CONSORT for abstracts statement checklist.
Results
Abstracts of 177 randomized controlled trials were identified and assessed. The distribution of published reports was in the Journal of periodontology (JOP), (42%) the Journal of periodontal research (JOPR) (7%) and the Journal of clinical periodontology (JOCP) (51%). The mean overall reporting quality score was 49.0%(95% CI: 47.7-50.2%). Most of the abstracts (91-100%) clearly reported and described the study design as randomized in the RCTs' title and recruitment status, as well as study interventions, objective(s), outcome(s) and conclusions. There was insufficient description and reporting of the authors' contact details, trial design, method of randomization, blinding, number of analyzed participants per group, harms, trial registration and source of funding.
Conclusions
The quality of reporting of abstracts of randomized controlled trials in periodontic journals is suboptimal. In view of the current guidelines of reporting RCTs abstracts, efforts should be made to better reporting.",2020,The mean overall reporting quality score was 49.0%(95% CI: 47.7-50.2%).,[],[],['mean overall reporting quality score'],[],[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0897122,The mean overall reporting quality score was 49.0%(95% CI: 47.7-50.2%).,"[{'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Alharbi', 'Affiliation': 'Department of Preventive Dental Sciences, Prince Sattam Bin Abdulaziz University, Saudi Arabia.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Almutairi', 'Affiliation': 'Department of Periodontology and Oral Medicine, College of Dentistry, Qassim University, Saudi Arabia.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100656']
1545,33134767,Administration of Denosumab Preserves Bone Mineral Density at the Knee in Persons With Subacute Spinal Cord Injury: Findings From a Randomized Clinical Trial.,"Persons with neurologically motor-complete spinal cord injury (SCI) have a marked loss of bone mineral density (BMD) of the long bones of the lower extremities, predisposing them to fragility fractures, especially at the knee. Denosumab, a commercially available human monoclonal IgG antibody to receptor activator of nuclear factor-κB ligand (RANKL), may provide an immunopharmacological solution to the rapid progressive deterioration of sublesional bone after SCI. Twenty-six SCI participants with subacute motor-complete SCI were randomized to receive either denosumab (60 mg) or placebo at baseline (BL), 6, and 12 months. Areal bone mineral density (aBMD) by dual energy x-ray absorptiometry (DXA) at 18 months at the distal femur was the primary outcome and aBMD of the proximal tibia and hip were the secondary outcomes analyzed in 18 of the 26 participants (denosumab, n = 10 and placebo, n = 8). The metrics of peripheral QCT (pQCT) were the exploratory outcomes analyzed in a subsample of the cohort (denosumab, n = 7 and placebo n = 7). The mean aBMD (±95% CI) for the denosumab versus the placebo groups demonstrated a significant group × time interactions for the following regions of interest at BL and 18 months: distal femoral metaphysis = mean aBMD 1.187; 95% CI, 1.074 to 1.300 and mean aBMD 1.202; 95% CI, 1.074 to 1.329 versus mean aBMD 1.162; 95% CI, 0.962 to 1.362 and mean aBMD 0.961; 95% CI, 0.763 to 1.159, respectively ( p < 0.001); distal femoral epiphysis = mean aBMD 1.557; 95% CI, 1.437 to 1.675 and mean aBMD 1.570; 95% CI, 1.440 to 1.700 versus mean aBMD 1.565; 95% CI, 1.434 to 1.696 and mean aBMD 1.103; 95% CI, 0.898 to 1.309, respectively ( p = 0.002); and proximal tibial epiphysis = mean aBMD 1.071; 95% CI, 0.957 to 1.186 and mean aBMD 1.050; 95% CI, 0.932 to 1.168 versus mean aBMD 0.994; 95% CI, 0.879 to 1.109 and mean aBMD 0.760; 95% CI, 0.601 to 0.919, respectively ( p < 0.001). Analysis of pQCT imaging revealed a continued trend toward significantly greater loss in total volumetric BMD (vBMD) and trabecular vBMD at the 4% distal tibia region, with a significant percent loss for total bone mineral content. Thus, at 18 months after acute SCI, our findings show that denosumab maintained aBMD at the knee region, the site of greatest clinical relevance in the SCI population. © 2020 The Authors. JBMR Plus published by Wiley Periodicals LLC. on behalf of American Society for Bone and Mineral Research.",2020,"The mean aBMD (±95% CI) for the denosumab versus the placebo groups demonstrated a significant group × time interactions for the following regions of interest at BL and 18 months: distal femoral metaphysis = mean aBMD 1.187; 95% CI, 1.074 to 1.300 and mean aBMD 1.202; 95% CI, 1.074 to 1.329 versus mean aBMD 1.162; 95% CI, 0.962 to 1.362 and mean aBMD 0.961; 95% CI, 0.763 to 1.159, respectively ( p < 0.001); distal femoral epiphysis = mean aBMD 1.557; 95% CI, 1.437 to 1.675 and mean aBMD 1.570; 95% CI, 1.440 to 1.700 versus mean aBMD 1.565; 95% CI, 1.434 to 1.696 and mean aBMD 1.103; 95% CI, 0.898 to 1.309, respectively ( p = 0.002); and proximal tibial epiphysis = mean aBMD 1.071; 95% CI, 0.957 to 1.186 and mean aBMD 1.050; 95% CI, 0.932 to 1.168 versus mean aBMD 0.994; 95% CI, 0.879 to 1.109 and mean aBMD 0.760; 95% CI, 0.601 to 0.919, respectively ( p < 0.001).","['Persons with neurologically motor-complete spinal cord injury (SCI', '2020', 'sublesional bone after SCI. Twenty-six SCI participants with subacute motor-complete SCI', 'Persons With Subacute Spinal Cord Injury']","['Denosumab', 'placebo', 'denosumab', 'peripheral QCT (pQCT']","['Areal bone mineral density (aBMD', 'bone mineral density (BMD', 'mean aBMD', 'total volumetric BMD (vBMD) and trabecular vBMD', 'total bone mineral content', 'Bone Mineral Density']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3544168', 'cui_str': 'Complete spinal cord injury'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0412669', 'cui_str': 'Computerized tomography, bone density study'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}]",26.0,0.203503,"The mean aBMD (±95% CI) for the denosumab versus the placebo groups demonstrated a significant group × time interactions for the following regions of interest at BL and 18 months: distal femoral metaphysis = mean aBMD 1.187; 95% CI, 1.074 to 1.300 and mean aBMD 1.202; 95% CI, 1.074 to 1.329 versus mean aBMD 1.162; 95% CI, 0.962 to 1.362 and mean aBMD 0.961; 95% CI, 0.763 to 1.159, respectively ( p < 0.001); distal femoral epiphysis = mean aBMD 1.557; 95% CI, 1.437 to 1.675 and mean aBMD 1.570; 95% CI, 1.440 to 1.700 versus mean aBMD 1.565; 95% CI, 1.434 to 1.696 and mean aBMD 1.103; 95% CI, 0.898 to 1.309, respectively ( p = 0.002); and proximal tibial epiphysis = mean aBMD 1.071; 95% CI, 0.957 to 1.186 and mean aBMD 1.050; 95% CI, 0.932 to 1.168 versus mean aBMD 0.994; 95% CI, 0.879 to 1.109 and mean aBMD 0.760; 95% CI, 0.601 to 0.919, respectively ( p < 0.001).","[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cirnigliaro', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury James J. Peters Veterans Affairs Medical Center Bronx NY USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'La Fountaine', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury James J. Peters Veterans Affairs Medical Center Bronx NY USA.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Parrott', 'Affiliation': 'Department of Interdisciplinary Studies School of Health Professions, Rutgers Biomedical and Health Sciences Newark NJ USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Kirshblum', 'Affiliation': 'Kessler Institute for Rehabilitation West Orange NJ USA.'}, {'ForeName': 'Cristin', 'Initials': 'C', 'LastName': 'McKenna', 'Affiliation': 'Kessler Institute for Rehabilitation West Orange NJ USA.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Sauer', 'Affiliation': 'Kessler Institute for Rehabilitation West Orange NJ USA.'}, {'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Shapses', 'Affiliation': 'Department of Nutritional Sciences, School of Environmental and Biological Sciences Rutgers University New Brunswick NJ USA.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': 'Department of Nutritional Sciences, School of Environmental and Biological Sciences Rutgers University New Brunswick NJ USA.'}, {'ForeName': 'Isa A', 'Initials': 'IA', 'LastName': 'McClure', 'Affiliation': 'Kessler Institute for Rehabilitation West Orange NJ USA.'}, {'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Hobson', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Spungen', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury James J. Peters Veterans Affairs Medical Center Bronx NY USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Bauman', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury James J. Peters Veterans Affairs Medical Center Bronx NY USA.'}]",JBMR plus,['10.1002/jbm4.10375']
1546,33134780,Effects of thrombomodulin alfa on hemostatic parameters in disseminated intravascular coagulation: Post hoc analysis of a phase 3 randomized controlled trial.,"Background
The efficacy and safety of thrombomodulin alfa (TM-α), a cofactor protein promoting thrombin-mediated protein C activation, have been examined in a phase 3 randomized, double-blinded, parallel-group trial in Japan. We have previously reported that TM-α is noninferior to heparin for the resolution of disseminated intravascular coagulation (DIC).
Objective
To investigate the basis for the efficacy of TM-α in the phase 3 clinical trial in Japan through post hoc analysis of coagulation and fibrinolysis parameters.
Patients/Methods
The 227 patients of the full analysis set population described in the original phase 3 trial in Japan were included in this analysis. Changes in parameters between before and after TM-α or heparin administration in each of the two patient groups, with underlying diseases of either hematologic malignancy or infection, were studied separately and results were compared between TM-α and heparin treatment groups in a post hoc manner.
Results
TM-α administration did not prolong activated partial thromboplastin time but significantly decreased thrombin-antithrombin complex levels compared with heparin treatment. TM-α administration reduced consumption of endogenous anticoagulants such as antithrombin and protein C by DIC, compared with the heparin group. DIC scores were decreased in both TM-α and heparin groups during the 6-day treatment.
Conclusion
TM-α can alleviate intravascular coagulation and consumption of anticoagulants without extending coagulation times. This may be associated with the relatively low risk of bleeding during TM-α treatment.",2020,"TM-α administration reduced consumption of endogenous anticoagulants such as antithrombin and protein C by DIC, compared with the heparin group.","['227 patients of the full analysis set population described in the original phase 3 trial in Japan', 'disseminated intravascular coagulation']","['thrombomodulin alfa (TM-α', 'TM-α or heparin', 'TM-α', 'TM-α and heparin', 'thrombomodulin alfa', 'heparin']","['activated partial thromboplastin time', 'thrombin-antithrombin complex levels', 'DIC scores', 'hematologic malignancy or infection', 'hemostatic parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0012739', 'cui_str': 'Disseminated intravascular coagulation'}]","[{'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0052128', 'cui_str': 'Thrombin-antithrombin complex'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012739', 'cui_str': 'Disseminated intravascular coagulation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.217599,"TM-α administration reduced consumption of endogenous anticoagulants such as antithrombin and protein C by DIC, compared with the heparin group.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Department of Systems Biology in Thromboregulation Kagoshima University Graduates School of Medical and Dental Sciences Kagoshima Japan.'}, {'ForeName': 'Ikuro', 'Initials': 'I', 'LastName': 'Maruyama', 'Affiliation': 'Department of Systems Biology in Thromboregulation Kagoshima University Graduates School of Medical and Dental Sciences Kagoshima Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Shimazaki', 'Affiliation': 'Department of Emergency Medical System Disaster and EMS Rescue Institute Kokushikan University Tokyo Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Tokyo Hikifune Hospital Tokyo Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Aikawa', 'Affiliation': 'Keio University Tokyo Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Hirayama', 'Affiliation': 'Ogino Hospital Hokkaido Japan.'}, {'ForeName': 'Goichi', 'Initials': 'G', 'LastName': 'Honda', 'Affiliation': 'Asahi Kasei Pharma Corporation Tokyo Japan.'}, {'ForeName': 'Hidehiko', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'National Hospital Organization Nagoya Medical Center Aichi Japan.'}]",Research and practice in thrombosis and haemostasis,['10.1002/rth2.12419']
1547,33135003,The Effect of Acromioplasty on the Critical Shoulder Angle and Acromial Index.,"Purpose
To evaluate the effect of acromioplasty using a cutting block technique on bony coverage as measured by the critical shoulder angle (CSA) and acromial index (AI).
Methods
This study is a retrospective radiographic review using data from a previous prospective randomized clinical trial that offered enrollment to patients aged 18 years or older with a full-thickness tear of the superior rotator cuff between October 2007 and January 2011. Each patient was allocated to repair with either acromioplasty using a cutting block technique or non-acromioplasty treatment arms in a blinded fashion. Medical and demographic information was recorded for each patient. Between January 2017 and December 2017, patients were contacted for repeat follow-up clinical evaluation and radiographs. Measurements of acromial index and critical shoulder angle were performed on pre- and postoperative radiographs by a single reviewer.
Results
Seventy-one (75%) patients were available for follow up. The 2 groups were similar in terms of baseline demographics and acromial type. When compared with preoperative measures, acromioplasty did not result in significant reductions in mean CSA (34.5° vs 35.5°; P = .293) or AI (0.68 vs 0.66; P = .283). Furthermore, postoperative CSA (34.5° vs 36.2°, P = .052) and AI (0.66 vs 0.67, P = .535) demonstrated no statistically significant differences between patients with and without acromioplasty, respectively.
Conclusions
There was no statistically significant change in either the CSA or AI following acromioplasty, nor was there a significant postoperative difference in CSA or AI between the group that underwent acromioplasty and the group that did not.
Clinical Relevance
Some studies suggest a greater postoperative CSA may result in greater risk of retear after arthroscopic rotator cuff repair. The CSA and AI may not be modifiable with acromioplasty.",2020,"Furthermore, postoperative CSA (34.5° vs 36.2°, P = .052) and AI (0.66 vs 0.67, P = .535) demonstrated no statistically significant differences between patients with and without acromioplasty, respectively.
","['patients aged 18 years or older with a full-thickness tear of the superior rotator cuff between October 2007 and January 2011', 'Between January 2017 and December 2017, patients were contacted for repeat follow-up clinical evaluation and radiographs']","['acromioplasty using a cutting block technique', 'acromioplasty using a cutting block technique or non-acromioplasty treatment', 'Acromioplasty']","['critical shoulder angle (CSA) and acromial index (AI', 'mean CSA', 'Furthermore, postoperative CSA', 'CSA or AI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439809', 'cui_str': 'Full thickness'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]","[{'cui': 'C0186663', 'cui_str': 'Acromioplasty of shoulder'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",,0.0883149,"Furthermore, postoperative CSA (34.5° vs 36.2°, P = .052) and AI (0.66 vs 0.67, P = .535) demonstrated no statistically significant differences between patients with and without acromioplasty, respectively.
","[{'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'MacLean', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Anirudh K', 'Initials': 'AK', 'LastName': 'Gowd', 'Affiliation': 'Department of Orthopaedic Surgery, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, U.S.A.'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Waterman', 'Affiliation': 'Section of Sports Medicine, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, U.S.A.'}, {'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Dempsey', 'Affiliation': 'Section of Sports Medicine, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Bach', 'Affiliation': 'Section of Sports Medicine, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Cole', 'Affiliation': 'Section of Sports Medicine, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Romeo', 'Affiliation': 'Section of Shoulder and Elbow Surgery, Rothman Institute, Philadelphia, Pennsylvania, U.S.A.'}, {'ForeName': 'Nikhil N', 'Initials': 'NN', 'LastName': 'Verma', 'Affiliation': 'Section of Sports Medicine, Rush University Medical Center, Chicago, Illinois, U.S.A.'}]","Arthroscopy, sports medicine, and rehabilitation",['10.1016/j.asmr.2020.07.012']
1548,33135179,The Children's Health and Maintenance Program (CHAMP): An innovative community outreach oral health promotion program: A randomized trial.,"OBJECTIVE
To describe CHAMP (Children's Oral Health Promotion Program) evaluating the impact of two motivational methods in increasing dental care access.
METHODS
CHAMP is a multi-dimensional oral health promotion programme that recruited and screened underprivileged children/families from community sites in Los Angeles County between 2012 and 2018. A randomized clinical trial (RCT) enrolled children/families into one or more motivational interventions (intra-oral camera and/or social work consultation) designed to impact subsequent scheduling of dental appointments.
RESULTS
CHAMP served 24 535 families. RCT had 418 families with 68.5% scheduling appointments by second follow-up (P < .001). Excluding children with scheduled appointments by first follow-up, children experiencing both interventions were 4.1 (95% CI 1.5-11.2) times more likely to schedule appointments by second follow-up than were the controls (P=<.01). When experiencing both interventions and had never previously been to the dentist, 68.3% scheduled dental appointments; this was significantly higher than the controls (46.7%) (P = .04). The best predictor for families to have scheduled appointments was a dental visit within the last six months [OR = 3.8 (95% CI 2.2-6.6), P < .001].
CONCLUSIONS
Outreach health promotion programmes are important and should consider utilizing various motivational techniques to encourage enrolment and treatment at dental homes.",2020,RCT had 418 families with 68.5% scheduling appointments by second follow-up (P < .001).,"['CHAMP is a multi-dimensional oral health promotion programme that recruited and screened underprivileged children/families from community sites in Los Angeles County between 2012 and 2018', ""Children's Health and Maintenance Program (CHAMP"", 'children/families into one or more motivational interventions (intra-oral camera and/or social work consultation) designed to impact subsequent scheduling of dental appointments']",[],[],"[{'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0150290', 'cui_str': 'Oral health promotion'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]",[],[],24535.0,0.0401496,RCT had 418 families with 68.5% scheduling appointments by second follow-up (P < .001).,"[{'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Seirawan', 'Affiliation': 'Herman Ostrow School of Dentistry of USC, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Parungao', 'Affiliation': 'Herman Ostrow School of Dentistry of USC, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Habibian', 'Affiliation': 'Herman Ostrow School of Dentistry of USC, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Slusky', 'Affiliation': 'Herman Ostrow School of Dentistry of USC, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Edwards', 'Affiliation': 'Herman Ostrow School of Dentistry of USC, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Artavia', 'Affiliation': 'USC Dworak-Peck School of Social Work, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Cen', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Chan', 'Affiliation': 'Herman Ostrow School of Dentistry of USC, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Roseann', 'Initials': 'R', 'LastName': 'Mulligan', 'Affiliation': 'Herman Ostrow School of Dentistry of USC, University of Southern California, Los Angeles, CA, USA.'}]",Community dentistry and oral epidemiology,['10.1111/cdoe.12591']
1549,33135182,Prediction of Fracture Risk From Early-Stage Bone Markers in Patients With Osteoporosis Treated With Once-Yearly Administered Zoledronic Acid.,"The prevention of fractures is the ultimate goal of osteoporosis treatments. To achieve this objective, developing a method to predict fracture risk in the early stage of osteoporosis treatment would be clinically useful. This study aimed to develop a mathematical model quantifying the long-term fracture risk after 2 annual doses of 5 mg of once-yearly administered zoledronic acid or placebo based on the short-term measurement of bone turnover markers or bone mineral density (BMD). The data used in this analysis were obtained from a randomized, placebo-controlled, double-blind, 2-year study of zoledronic acid that included 656 patients with primary osteoporosis. Two-year individual bone resorption marker (tartrate-resistant acid phosphatase 5b [TRACP-5b]) and lumbar spine (L2-L4) BMD profiles were simulated using baseline values and short-term measurements (at 3 months for TRACP-5b and 6 months for BMD) according to the pharmacodynamic model. A new parametric time-to-event model was developed to describe the risk of clinical fractures. Fracture risk was estimated using TRACP-5b or BMD and the number of baseline vertebral fractures. As a result, the fracture risk during the 2 years was successfully predicted using TRACP-5b or BMD. The 90% prediction intervals well covered the observed fracture profiles in both models. Therefore, TRACP-5b or BMD is useful to predict the fracture risk of patients with osteoporosis, and TRACP-5b would be more useful because it is an earlier marker. Importantly, the developed model allows clinicians to inform patients of their predicted response at the initial stage of zoledronic acid treatment.",2020,Two-year individual bone resorption marker (tartrate-resistant acid phosphatase 5b [TRACP-5b]) and lumbar spine (L2-L4) BMD profiles were simulated using baseline values and short-term measurements (at 3 months for TRACP-5b and 6 months for BMD) according to the pharmacodynamic model.,"['Patients With Osteoporosis', '656 patients with primary osteoporosis']","['TRACP-5b', 'zoledronic acid', 'Zoledronic Acid', 'placebo', 'zoledronic acid or placebo']","['bone resorption marker (tartrate-resistant acid phosphatase 5b [TRACP-5b]) and lumbar spine (L2-L4) BMD profiles', 'fracture risk', 'bone turnover markers or bone mineral density (BMD', 'Fracture Risk', 'Fracture risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0410438', 'cui_str': 'Primary osteoporosis'}]","[{'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",656.0,0.0364577,Two-year individual bone resorption marker (tartrate-resistant acid phosphatase 5b [TRACP-5b]) and lumbar spine (L2-L4) BMD profiles were simulated using baseline values and short-term measurements (at 3 months for TRACP-5b and 6 months for BMD) according to the pharmacodynamic model.,"[{'ForeName': 'Hidefumi', 'Initials': 'H', 'LastName': 'Kasai', 'Affiliation': 'Department of Clinical Pharmacokinetics and Pharmacodynamics, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Mori', 'Affiliation': 'Development Planning, Clinical Development Center, Asahi Kasei Pharma Corporation, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ose', 'Affiliation': 'Development Planning, Clinical Development Center, Asahi Kasei Pharma Corporation, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Shiraki', 'Affiliation': 'Department of Internal Medicine, Research Institute and Practice for Involutional Diseases, Azumino, Nagano, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Tanigawara', 'Affiliation': 'Department of Clinical Pharmacokinetics and Pharmacodynamics, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.'}]",Journal of clinical pharmacology,['10.1002/jcph.1774']
1550,33135283,Assessing clinical education tools for expanded carrier screening.,"Expanded carrier screening (ECS) is increasingly offered to a broader population and raises challenges of how to best educate and counsel the volume of screened individuals. For this study, we compared three educational tools (brochure, video and comic) about ECS on knowledge and decision making. A convenience online sample of 151 pregnant women was randomized to one of three groups (Video, n = 42; Comic n = 54; Brochure n = 55). Knowledge scores were significantly higher for the comic group compared to the video or the brochure groups (p < .001). No significant differences in preparation for decision making, decisional conflict, or perceptions of shared decision making were identified between the study groups. This study suggests that a comic about ECS may improve patient attention and retention of information. The use of graphic narratives may enable individuals to better understand medical information in general.",2020,"No significant differences in preparation for decision making, decisional conflict, or perceptions of shared decision making were identified between the study groups.",['151 pregnant women'],"['ECS', 'Expanded carrier screening (ECS']","['preparation for decision making, decisional conflict, or perceptions of shared decision making', 'Knowledge scores', 'patient attention and retention of information']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",151.0,0.0424223,"No significant differences in preparation for decision making, decisional conflict, or perceptions of shared decision making were identified between the study groups.","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Dugger', 'Affiliation': 'Graduate Program in Genetic Counseling, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Hannah S', 'Initials': 'HS', 'LastName': 'Anderson', 'Affiliation': 'ARUP Laboratories, Salt Lake City, UT, USA.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Miller', 'Affiliation': 'ARUP Laboratories, Salt Lake City, UT, USA.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Wong', 'Affiliation': 'College of Nursing, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Erin P', 'Initials': 'EP', 'LastName': 'Johnson', 'Affiliation': 'Department of Ob/Gyn, School of Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Rothwell', 'Affiliation': 'Department of Ob/Gyn, School of Medicine, University of Utah, Salt Lake City, UT, USA.'}]",Journal of genetic counseling,['10.1002/jgc4.1349']
1551,33135286,Comparing pain neuroscience education followed by motor control exercises with group-based exercises for chronic low back pain: a randomized controlled trial.,"BACKGROUND
Different individualized interventions have been used to improve chronic low back pain (CLBP). However, their superiority over group-based interventions is yet to be elucidated. We compared an individualized treatment involving pain neuroscience education (PNE) with motor control exercise (MCE) with group-based exercise (GE) in patients with CLBP.
METHODS
Seventy-three patients with CLBP were randomly assigned into PNE plus MCE group (n=37) and GE group (n=36). Both PNE plus MCE and GE were administered twice weekly for 8 weeks. Pain intensity (Visual Analogue Scale), disability (Roland-Morris Disability Questionnaire), fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire), and self-efficacy (Pain Self-Efficacy Questionnaire), measured at baseline and 8 weeks post-intervention. A 2 × 2 variance analysis (treatment group × time) with a mixed model design was applied to statistically analyze the data.
RESULTS
Both groups showed significant improvements in all the outcome measures with a large effect size (P<0.001, partial eta squared [ηp2] =0.66-0.81) after the intervention. The PNE plus MCE group showed greater improvements with a moderate effect size in pain intensity (P=0.041, ηp2=0.06) and disability (P=0.021, ηp2=0.07) compared to the GE group. No significant difference was found in fear-avoidance beliefs during physical activity and work, and self-efficacy (P>0.05) between the two groups.
CONCLUSION
PNE and MCE seem to be better at reducing pain intensity and disability compared to GE while no significant differences were observed for fear-avoidance beliefs and self-efficacy between two groups in patients with CLBP. To conclude on the superiority of individualized interventions over group-based ones, more studies are warranted.",2020,PNE and MCE seem to be better at reducing pain intensity and disability compared to GE while no significant differences were observed for fear-avoidance beliefs and self-efficacy between two groups in patients with CLBP.,"['chronic low back pain', 'patients with CLBP.\nMETHODS\n\n\nSeventy-three patients with CLBP']","['PNE plus MCE', 'pain neuroscience education followed by motor control exercises with group-based exercises', 'individualized treatment involving pain neuroscience education (PNE) with motor control exercise (MCE) with group-based exercise (GE', 'GE']","['chronic low back pain (CLBP', 'large effect size', 'fear-avoidance beliefs and self-efficacy', 'Pain intensity (Visual Analogue Scale), disability (Roland-Morris Disability Questionnaire), fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire), and self-efficacy (Pain Self-Efficacy Questionnaire', 'disability', 'fear-avoidance beliefs during physical activity and work, and self-efficacy', 'pain intensity and disability', 'moderate effect size in pain intensity']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4075347', 'cui_str': 'Pain Self-efficacy Questionnaire'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",73.0,0.0688716,PNE and MCE seem to be better at reducing pain intensity and disability compared to GE while no significant differences were observed for fear-avoidance beliefs and self-efficacy between two groups in patients with CLBP.,"[{'ForeName': 'Pouya', 'Initials': 'P', 'LastName': 'Rabiei', 'Affiliation': 'Department of Physical Education and Sports Sciences, Islamic Azad University, Karaj, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Sheikhi', 'Affiliation': 'Sports Injury and Corrective Exercises, Faculty of Physical Education and Sports Sciences, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Sports Injury and Corrective Exercises, Faculty of Physical Education and Sports Sciences, Kharazmi University, Tehran, Iran.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12963']
1552,33135319,Analgesic effect of music during wound care among patients with diaphyseal tibial fractures: Randomized controlled trial.,"BACKGROUND
Evidence is scarce regarding the analgesic effect of music for the relief of acute pain during the care of surgical tibial fracture wounds.
OBJECTIVE
To evaluate the analgesic effect of music on acute procedural pain during the care of surgical tibial fracture wounds.
METHOD
This was a randomized, controlled, blinded clinical trial with 70 patients in the immediate postoperative period for diaphyseal tibial fracture surgery. Participants were randomly allocated to two groups: a control group (CG), in which patients received only the institution's standard analgesia, and an intervention group (IG) composed of patients receiving a 30 minute session of music of their own choice, as a complementary method to the institution's standard analgesia. Pain was evaluated during the first postoperative dressing change, using the Numerical Rating Scale (NRS).
RESULTS
The sample was homogeneously composed of men (91.4%), young adults (61.4%), without previous diseases (88.6%) and whose traumas were related to a motorcycle crash (84.3%). The main musical genres chosen by participants were the most popular in their region (61.4%). Those who listened to music presented lower pain scores when compared to those in the CG (IG:2.4±2.4 vs. CG:5.8±2.7; p<0.001; ƞ 2 =0.171; p<0.001).
CONCLUSION
Listening to music is effective for relieving acute procedural pain during the first post-operative tibial fracture dressing change. Music should be incorporated into the multimodal analgesia protocols for management of orthopedic postoperative wound care related pain.",2020,"Those who listened to music presented lower pain scores when compared to those in the CG (IG:2.4±2.4 vs. CG:5.8±2.7; p<0.001; ƞ 2 =0.171; p<0.001).
","['surgical tibial fracture wounds', '70 patients in the immediate postoperative period for diaphyseal tibial fracture surgery', 'patients with diaphyseal tibial fractures']","[""control group (CG), in which patients received only the institution's standard analgesia, and an intervention group (IG) composed of patients receiving a 30 minute session of music of their own choice, as a complementary method to the institution's standard analgesia""]","['Analgesic effect', 'Numerical Rating Scale (NRS', 'Pain', 'pain scores']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",70.0,0.124838,"Those who listened to music presented lower pain scores when compared to those in the CG (IG:2.4±2.4 vs. CG:5.8±2.7; p<0.001; ƞ 2 =0.171; p<0.001).
","[{'ForeName': 'Maria Cristina Leite', 'Initials': 'MCL', 'LastName': 'Ferraz', 'Affiliation': 'Instituto Federal de Educacao Ciencia e Tecnologia de Sergipe - Campus Lagarto São Cristóvão, Sergipe, Brazil.'}, {'ForeName': 'Eduesley', 'Initials': 'E', 'LastName': 'Santana-Santos', 'Affiliation': 'Instituto Federal de Educacao Ciencia e Tecnologia de Sergipe - Campus Lagarto São Cristóvão, Sergipe, Brazil.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Santana', 'Affiliation': 'Instituto Federal de Educacao Ciencia e Tecnologia de Sergipe - Campus Lagarto São Cristóvão, Sergipe, Brazil.'}, {'ForeName': 'Caíque Jordan', 'Initials': 'CJ', 'LastName': 'Nunes Ribeiro', 'Affiliation': 'Instituto Federal de Educacao Ciencia e Tecnologia de Sergipe - Campus Lagarto São Cristóvão, Sergipe, Brazil.'}, {'ForeName': 'Joyce Francielle Nei Bomfim', 'Initials': 'JFNB', 'LastName': 'Santana', 'Affiliation': 'Instituto Federal de Educacao Ciencia e Tecnologia de Sergipe - Campus Lagarto São Cristóvão, Sergipe, Brazil.'}, {'ForeName': 'José Antonio Barreto', 'Initials': 'JAB', 'LastName': 'Alves', 'Affiliation': 'Instituto Federal de Educacao Ciencia e Tecnologia de Sergipe - Campus Lagarto São Cristóvão, Sergipe, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'do Carmo de Oliveira Ribeiro', 'Affiliation': 'Instituto Federal de Educacao Ciencia e Tecnologia de Sergipe - Campus Lagarto São Cristóvão, Sergipe, Brazil.'}]","European journal of pain (London, England)",['10.1002/ejp.1692']
1553,33136231,Effect of early tumor response on the health-related quality of life among patients on second-line chemotherapy for advanced gastric cancer in the ABSOLUTE trial.,"BACKGROUND
This study evaluated the association between early tumor response at 8 weeks, previously reported as a positive outcome prognosticator, and health-related quality of life (HRQOL) in advanced gastric cancer (AGC) patients enrolled in the ABSOLUTE trial.
METHODS
HRQOL was assessed using the EuroQol-5 Dimension (EQ-5D) utility index score in patients with complete response (CR) + partial response (PR) and progressive disease (PD) at 8 weeks, and time-to-deterioration (TtD) of the EQ-5D score, with the preset minimally important difference (MID) of 0.05, was compared between these populations. Among the enrolled patients, 143 and 160 patients were assessable in weekly solvent-based paclitaxel (Sb-PTX) arm and weekly nanoparticle albumin-bound paclitaxel (nab-PTX) arm, respectively.
RESULTS
Changes of the EQ-5D score from baseline to 8 weeks in the nab-PTX arm were 0.0009 and - 0.1229 in CR + PR and PD patients, respectively; the corresponding values for the Sb-PTX arm were - 0.0019 and - 0.1549. For both treatments, changes of the EQ-5D score from baseline at 8 weeks were significantly larger in patients with PD than in those with CR + PR. The median TtD was 3.9 and 2.2 months in patients with CR + PR and PD, respectively, for nab-PTX [hazard ratio (HR) = 0.595, 95% confidence interval (CI) 0.358-0.989]. For Sb-PTX, the corresponding values were 4.7 and 2.0 months (HR = 0.494, 95% CI 0.291-0.841).
CONCLUSIONS
Early tumor shrinkage was associated with maintained HRQOL in AGC patients on the second-line chemotherapy with taxanes.",2020,"For both treatments, changes of the EQ-5D score from baseline at 8 weeks were significantly larger in patients with PD than in those with CR + PR.","['enrolled patients, 143 and 160 patients were assessable in weekly', 'patients on second-line chemotherapy for advanced gastric cancer', 'advanced gastric cancer (AGC) patients enrolled in the ABSOLUTE trial']","['solvent-based paclitaxel (Sb-PTX) arm and weekly nanoparticle albumin-bound paclitaxel (nab-PTX', 'taxanes']","['EQ-5D score', 'health-related quality of life', 'median TtD', 'time-to-deterioration (TtD) of the EQ-5D score', 'EuroQol-5 Dimension (EQ-5D) utility index score', 'complete response (CR)\u2009+\u2009partial response (PR) and progressive disease (PD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0037638', 'cui_str': 'Solvent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",160.0,0.0962519,"For both treatments, changes of the EQ-5D score from baseline at 8 weeks were significantly larger in patients with PD than in those with CR + PR.","[{'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, 3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka, 558-0056, Japan. fujitani@gh.opho.jp.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Takashima', 'Affiliation': 'Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Koeda', 'Affiliation': 'Department of Medical Safety Science, Iwate Medical University, Morioka, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Ina-machi, Japan.'}, {'ForeName': 'Norisuke', 'Initials': 'N', 'LastName': 'Nakayama', 'Affiliation': 'Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Clinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': 'Department of Surgery, Sakai City Medical Center, Sakai, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Amagai', 'Affiliation': 'Department of Gastroenterology, Ibaraki Prefectural Central Hospital, Kasama, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Hosaka', 'Affiliation': 'Division of Gastroenterology, Gunma Prefectural Cancer Center, Ohta, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Komatsu', 'Affiliation': 'Division of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Shimada', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Showa University Northern Yokohama Hospital, Yokohama, Japan.'}, {'ForeName': 'Ryohei', 'Initials': 'R', 'LastName': 'Kawabata', 'Affiliation': 'Department of Surgery, Osaka Rosai Hospital, Osaka, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ohdan', 'Affiliation': 'Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Kodera', 'Affiliation': 'Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Aizawa Comprehensive Cancer Center, Aizawa Hospital, Nagano, Japan.'}, {'ForeName': 'Takako Eguchi', 'Initials': 'TE', 'LastName': 'Nakajima', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': 'Department of Medical Oncology, Saku Central Hospital Advanced Care Center, Saku, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Moriwaki', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Kusumoto', 'Affiliation': 'Department of Gastroenterological Surgery and Clinical Research Institute Cancer Research Division, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Medical Oncology and Hematology, Faculty of Medicine, Oita University, Oita, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Ogata', 'Affiliation': 'Medical Affairs Department, Taiho Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Shimura', 'Affiliation': 'Data Science Department, Taiho Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Wasaburo', 'Initials': 'W', 'LastName': 'Koizumi', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-020-01131-y']
1554,33136253,A randomised trial of pharmacist-led discharge prescribing in an Australian geriatric evaluation and management service.,"Background Prescribing discharge medications is a potential ""next step"" for pharmacists in Australian hospitals, however, safety must be demonstrated via a randomised controlled study. Objective To determine if a collaborative, pharmacist led discharge prescribing model results in less patients with medication errors than conventional prescribing for both handwritten and digital prescriptions. Setting Geriatric Medical ward in a quaternary hospital, Australia Methods A prospective, single-blinded randomised controlled study of patients randomised to conventional (control) or a pharmacist-led prescribing (intervention) arms at discharge from hospital. This study had 2 phases; (1) handwritten prescribing and (2) digital prescribing. In addition, the two prescribing methods were compared. Main outcome measures The primary outcome was the percentage of patients with a medication error on their discharge prescription. Results In phase 1, 45 patients were recruited; 21 (control) and 24 (intervention). 95% of control patients and 29% in the intervention arm had at least one medication error, p < 0.0002, relative risk (RR) 0.31, confidence interval (CI) 0.16-0.58. The number of items with at least 1 error reduced from 69 to 4%; p < 0.0001, RR 0.06, CI 0.03-0.11 and fewer items had at least 1 clinically significant error (11% vs 2%, p = 0.0004, RR 0.15, CI 0.04-0.30). In phase 2, 39 patients were recruited; 18 (control) and 21 (intervention). 100% of control patients and 62% in the intervention arm had at least one medication error (p = 0.005, RR 0.62, CI 0.44-0.87). Items with at least 1 error decreased from 21 to 7% (p < 0.0001, RR 0.34, CI 0.44-0.56), there were fewer items with at least 1 clinically significant error (13% vs 5%, p < 0.003, RR 0.4, CI 0.22-0.72). There was no significant change in the primary outcome between handwritten and digital (60% vs 79%, p < 0.055). Conclusion In a geriatric setting, pharmacist-led partnered discharge prescribing results in significantly less patients with medication errors than the conventional method for both handwritten and digital methods.",2020,"The number of items with at least 1 error reduced from 69 to 4%; p < 0.0001, RR 0.06, CI 0.03-0.11 and fewer items had at least 1 clinically significant error (11% vs 2%, p = 0.0004, RR 0.15, CI 0.04-0.30).","['45 patients were recruited; 21 (control) and 24 (intervention', '39 patients were recruited; 18 (control) and 21 (intervention', 'Australian geriatric evaluation and management service', 'less patients with medication errors than conventional prescribing for both handwritten and digital prescriptions']","['pharmacist-led discharge prescribing', 'conventional (control) or a pharmacist-led prescribing (intervention']","['percentage of patients with a medication error on their discharge prescription', 'medication error']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]",,0.284538,"The number of items with at least 1 error reduced from 69 to 4%; p < 0.0001, RR 0.06, CI 0.03-0.11 and fewer items had at least 1 clinically significant error (11% vs 2%, p = 0.0004, RR 0.15, CI 0.04-0.30).","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Finn', 'Affiliation': 'Royal Brisbane and Womens Hospital, Brisbane, Australia. shannon.finn@health.qld.gov.au.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': ""D'arcy"", 'Affiliation': ', Brisbane, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Donovan', 'Affiliation': 'Royal Brisbane and Womens Hospital, Brisbane, Australia.'}, {'ForeName': 'Shanthi', 'Initials': 'S', 'LastName': 'Kanagarajah', 'Affiliation': 'Royal Brisbane and Womens Hospital, Brisbane, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Barras', 'Affiliation': 'Princess Alexandra Hospital, Brisbane, Australia.'}]",International journal of clinical pharmacy,['10.1007/s11096-020-01184-0']
1555,33124994,A Web Application About Herd Immunity Using Personalized Avatars: Development Study.,"BACKGROUND
Herd immunity or community immunity refers to the reduced risk of infection among susceptible individuals in a population through the presence and proximity of immune individuals. Recent studies suggest that improving the understanding of community immunity may increase intentions to get vaccinated.
OBJECTIVE
This study aims to design a web application about community immunity and optimize it based on users' cognitive and emotional responses.
METHODS
Our multidisciplinary team developed a web application about community immunity to communicate epidemiological evidence in a personalized way. In our application, people build their own community by creating an avatar representing themselves and 8 other avatars representing people around them, for example, their family or coworkers. The application integrates these avatars in a 2-min visualization showing how different parameters (eg, vaccine coverage, and contact within communities) influence community immunity. We predefined communication goals, created prototype visualizations, and tested four iterative versions of our visualization in a university-based human-computer interaction laboratory and community-based settings (a cafeteria, two shopping malls, and a public library). Data included psychophysiological measures (eye tracking, galvanic skin response, facial emotion recognition, and electroencephalogram) to assess participants' cognitive and affective responses to the visualization and verbal feedback to assess their interpretations of the visualization's content and messaging.
RESULTS
Among 110 participants across all four cycles, 68 (61.8%) were women and 38 (34.5%) were men (4/110, 3.6%; not reported), with a mean age of 38 (SD 17) years. More than half (65/110, 59.0%) of participants reported having a university-level education. Iterative changes across the cycles included adding the ability for users to create their own avatars, specific signals about who was represented by the different avatars, using color and movement to indicate protection or lack of protection from infectious disease, and changes to terminology to ensure clarity for people with varying educational backgrounds. Overall, we observed 3 generalizable findings. First, visualization does indeed appear to be a promising medium for conveying what community immunity is and how it works. Second, by involving multiple users in an iterative design process, it is possible to create a short and simple visualization that clearly conveys a complex topic. Finally, evaluating users' emotional responses during the design process, in addition to their cognitive responses, offers insights that help inform the final design of an intervention.
CONCLUSIONS
Visualization with personalized avatars may help people understand their individual roles in population health. Our app showed promise as a method of communicating the relationship between individual behavior and community health. The next steps will include assessing the effects of the application on risk perception, knowledge, and vaccination intentions in a randomized controlled trial. This study offers a potential road map for designing health communication materials for complex topics such as community immunity.",2020,"We predefined communication goals, created prototype visualizations, and tested four iterative versions of our visualization in a university-based human-computer interaction laboratory and community-based settings (a cafeteria, two shopping malls, and a public library).","['110 participants across all four cycles, 68 (61.8%) were women and 38 (34.5%) were men (4/110, 3.6%; not reported), with a mean age of 38 (SD 17) years']",[],"['risk perception, knowledge, and vaccination intentions', ""psychophysiological measures (eye tracking, galvanic skin response, facial emotion recognition, and electroencephalogram) to assess participants' cognitive and affective responses to the visualization and verbal feedback to assess their interpretations of the visualization's content and messaging""]","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0016989', 'cui_str': 'Galvanic skin response'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",110.0,0.0683283,"We predefined communication goals, created prototype visualizations, and tested four iterative versions of our visualization in a university-based human-computer interaction laboratory and community-based settings (a cafeteria, two shopping malls, and a public library).","[{'ForeName': 'Hina', 'Initials': 'H', 'LastName': 'Hakim', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Bettinger', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Christine T', 'Initials': 'CT', 'LastName': 'Chambers', 'Affiliation': 'Department of Psychology and Neuroscience and Pediatrics, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'S Michelle', 'Initials': 'SM', 'LastName': 'Driedger', 'Affiliation': 'Department of Community Health Sciences, University of Manitoba, Winnipeg, MB, Canada, Winnipeg, MB, Canada.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Dubé', 'Affiliation': 'Institut national de santé publique du Québec, Institut national de santé publique du Québec, Quebec City, QC, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gavaruzzi', 'Affiliation': 'Department of Developmental Psychology and Socialization, University of Padova, Italy, Padova, Italy.'}, {'ForeName': 'Anik M C', 'Initials': 'AMC', 'LastName': 'Giguere', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Kavanagh', 'Affiliation': 'École de design, Édifice La Fabrique, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Leask', 'Affiliation': 'Faculty of Medicine and Health, Susan Wakil School of Nursing and Midwifery, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Shannon E', 'Initials': 'SE', 'LastName': 'MacDonald', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Orji', 'Affiliation': 'Faculty of Computer Science, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Parent', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Jean-Sébastien', 'Initials': 'JS', 'LastName': 'Paquette', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Jacynthe', 'Initials': 'J', 'LastName': 'Roberge', 'Affiliation': 'École de design, Édifice La Fabrique, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Sander', 'Affiliation': 'University Health Network, Toronto General Hospital, Eaton Building, Toronto, ON, Canada.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Scherer', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa, IA, United States.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tremblay-Breault', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Kumanan', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, Bruyere Research Institute and Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Reinharz', 'Affiliation': 'Department of Social and Preventive Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Holly O', 'Initials': 'HO', 'LastName': 'Witteman', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}]",Journal of medical Internet research,['10.2196/20113']
1556,33124996,"Authors' Reply to: Comment on ""Facebook as a Novel Tool for Continuous Professional Education on Dementia: Pilot Randomized Controlled Trial"".",,2020,,[],[],[],[],[],[],,0.0646693,,"[{'ForeName': 'Windy Sy', 'Initials': 'WS', 'LastName': 'Chan', 'Affiliation': 'School of Health Sciences, Caritas Institute of Higher Education, New Territories, Hong Kong.'}, {'ForeName': 'Angela Ym', 'Initials': 'AY', 'LastName': 'Leung', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}]",Journal of medical Internet research,['10.2196/24084']
1557,33120324,The effects of the Fordyce's 14 fundamentals for happiness program on happiness and caregiver burden among the family caregivers of patients with epilepsy: A randomized controlled trial.,"BACKGROUND
Caregiving to patients with epilepsy (PWE) is often very stressful for family caregivers and puts a heavy caregiver burden (CB) on them. The aim of this study was to evaluate the effects of Fordyce's fourteen Fundamentals for Happiness Program on happiness and CB among the family caregivers of PWE.
METHODS
This randomized controlled trial was conducted on seventy family caregivers of PWE. Participants were purposively recruited from the Comprehensive Health Center in Shahrekord, Iran, and randomly allocated to either an intervention or a control group. Participants in the control group received conventional health-related educations in four one-hour group sessions, while participants in the intervention group received the Fordyce's fourteen Fundamentals for Happiness Program in eight one-hour group sessions. Happiness and CB in both groups were assessed at three time points, namely before, immediately after, and two months after the intervention. Data were analyzed using the SPSS program (v. 18.0).
FINDINGS
There were no significant differences between the control and the intervention groups regarding participants' demographic characteristics and their pretest mean scores of happiness and CB (P > 0.05). The mean scores of happiness and CB in the control group did not significantly change (P > 0.05), while the mean score of happiness significantly increased and the mean score of CB significantly decreased in the intervention group across the three measurement time points (P < 0.05). Consequently, the mean score of happiness in the intervention group was significantly greater than the control group and the mean score of CB in the intervention group was significantly less than the control group at both posttests (P < 0.01).
CONCLUSION
The Fordyce's fourteen Fundamentals for Happiness Program is effective in significantly increasing happiness and reducing CB among the family caregivers of PWE. Healthcare providers and policy makers can use this program to reduce problems among these family caregivers.",2020,There were no significant differences between the control and the intervention groups regarding participants' demographic characteristics and their pretest mean scores of happiness and CB (P > 0.05).,"['Participants were purposively recruited from the Comprehensive Health Center in Shahrekord, Iran', ""Fordyce's fourteen Fundamentals for Happiness Program on happiness and CB among the family caregivers of PWE"", 'patients with epilepsy (PWE', 'seventy family caregivers of PWE', 'family caregivers of patients with epilepsy']","['happiness program', ""conventional health-related educations in four one-hour group sessions, while participants in the intervention group received the Fordyce's fourteen Fundamentals for Happiness Program in eight one-hour group sessions""]","['mean scores of happiness and CB', 'happiness and caregiver burden', 'mean score of happiness', 'mean score of CB', 'Happiness and CB']","[{'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0221218', 'cui_str': ""Fordyce's disease""}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0221218', 'cui_str': ""Fordyce's disease""}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",70.0,0.0376502,There were no significant differences between the control and the intervention groups regarding participants' demographic characteristics and their pretest mean scores of happiness and CB (P > 0.05).,"[{'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Rabiei', 'Affiliation': 'Social Determinants of Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: Leila_rabiei@yahoo.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Lotfizadeh', 'Affiliation': 'Social Determinants of Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: masoud_lotfizadeh@yahoo.com.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Karimi', 'Affiliation': 'Social Determinants of Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: zzkkarimmi@gmail.com.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Masoudi', 'Affiliation': 'Community-Oriented Nursing Midwifery Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: masoodi1383@yahoo.com.'}]",Seizure,['10.1016/j.seizure.2020.10.013']
1558,33121028,"Effects of S-PBL in Maternity Nursing Clinical Practicum on Learning Attitude, Metacognition, and Critical Thinking in Nursing Students: A Quasi-Experimental Design.","Due to the coronavirus disease (COVID-19) pandemic, there are many restrictions in effect in clinical nursing practice. Since effective educational strategies are required to enhance nursing students' competency in clinical practice, this study sought to evaluate the effectiveness of simulation problem-based learning (S-PBL). A quasi-experimental control group pretest-post-test design was used. Nursing students were allocated randomly to the control group ( n = 31) and the experimental group ( n = 47). Students in the control group participated in a traditional maternity clinical practicum for a week, while students in the experimental group participated S-PBL for a week. The students in the experimental group were trained in small groups using a childbirth patient simulator (Gaumard ® Noelle ® S554.100, Miami, USA) based on a standardized scenario related to obstetric care. The students' learning attitude, metacognition, and critical thinking were then measured via a self-reported questionnaire. Compared with the control group, the pre-post difference in learning attitude and critical thinking increased significantly ( p < 0.01) in the experimental group. S-PBL was found to be an effective strategy for improving nursing students' learning transfer. Thus, S-PBL that reflects various clinical situations is recommended to improve the training in maternal health nursing.",2020,"Compared with the control group, the pre-post difference in learning attitude and critical thinking increased significantly ( p < 0.01) in the experimental group.","['Nursing Students', 'Nursing students']","['traditional maternity clinical practicum', 'childbirth patient simulator (Gaumard ® Noelle ® S554.100, Miami, USA) based on a standardized scenario related to obstetric care', 'S-PBL']",['learning attitude and critical thinking'],"[{'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0032929', 'cui_str': 'Clinical Practicum'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4279941', 'cui_str': 'Critical Thinking'}]",,0.0150455,"Compared with the control group, the pre-post difference in learning attitude and critical thinking increased significantly ( p < 0.01) in the experimental group.","[{'ForeName': 'Hae Kyoung', 'Initials': 'HK', 'LastName': 'Son', 'Affiliation': 'College of Nursing, Eulji University, Seongnam 13135, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17217866']
1559,33125537,The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial.,"BACKGROUND
A randomized controlled pilot trial was conducted to assess if melanoma patients treated with immunotherapy had the number of grade 3 or 4 adverse events during treatment reduced by 50% using a tailored electronic patient-reported outcomes tool in addition to standard toxicity monitoring compared to standard monitoring alone. Secondary endpoints were: if more AEs were reported in the intervention group, if there was a difference between the two groups in the number of telephone consultations, extra out-patient visits, number of days in the hospital, days in steroid treatment and the time patients experienced grade 2 or higher toxicity.
PATIENTS AND METHODS
Melanoma patients receiving immunotherapy at the Department of Oncology, Odense University Hospital, Denmark participated. Standard care included assessment of AEs by a clinician before each treatment cycle using the Common Terminology Criteria for Adverse Events. In addition, patients randomized to the intervention reported their AEs weekly by an electronic PRO-tool based on the PRO-CTCAE platform.
RESULTS
One hundred forty-six melanoma patients were randomized. In this study, we did not detect a difference between the two groups in the number of grade 3 or 4 AEs (P = 0.983), in the overall number of AEs (P = 0.560) or in the time the patients in the two groups experienced grade 2 or higher toxicity (0.516). The number of phone contacts was significantly higher in the intervention group (P = 0.009) and there was a tendency towards patients in the intervention group having more extra visits (P = 0.156).
CONCLUSION
It has been examined if the number of severe AEs for melanoma patients receiving immunotherapy could be reduced by involving the patients in the reporting of symptoms. The results do not justify the expansion of the pilot study into a regular phase III study with this particular set-up. However, a significant difference in the number of phone contacts was found as patients in the intervention group called more frequently, indicating that their attention to AEs was increased. Even though the use of an electronic PRO tool could not reduce the number of severe AEs in this melanoma population, a positive impact on other endpoints such as QoL, communication, or treatment-planning, cannot be excluded.
TRIAL REGISTRATION
Clinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registered.",2020,"The number of phone contacts was significantly higher in the intervention group (P = 0.009) and there was a tendency towards patients in the intervention group having more extra visits (P = 0.156).
","['melanoma patients receiving', 'Melanoma patients receiving immunotherapy at the Department of Oncology, Odense University Hospital, Denmark participated', 'metastatic melanoma patients receiving', 'One hundred forty-six melanoma patients', 'melanoma patients treated with']","['immunotherapy', 'electronic PRO']","['number of phone contacts', 'grade 2 or higher toxicity', 'overall number of AEs', 'extra visits', 'number of telephone consultations, extra out-patient visits, number of days in the hospital, days in steroid treatment and the time patients experienced grade 2 or higher toxicity', 'number of grade 3 or 4 AEs', 'number of grade 3 or 4 adverse events']","[{'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0175745', 'cui_str': 'Telephone consultation'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.21476,"The number of phone contacts was significantly higher in the intervention group (P = 0.009) and there was a tendency towards patients in the intervention group having more extra visits (P = 0.156).
","[{'ForeName': 'Lærke K', 'Initials': 'LK', 'LastName': 'Tolstrup', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark. laerke.tolstrup@rsyd.dk.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Karin B', 'Initials': 'KB', 'LastName': 'Dieperink', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Möller', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Ann-Dorthe', 'Initials': 'AD', 'LastName': 'Zwisler', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Pappot', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Journal of patient-reported outcomes,['10.1186/s41687-020-00255-0']
1560,33125587,The Treatment Ambassador Program: A Highly Acceptable and Feasible Community-Based Peer Intervention for South Africans Living with HIV Who Delay or Discontinue Antiretroviral Therapy.,"We conducted a novel pilot randomized controlled trial of the Treatment Ambassador Program (TAP), an 8-session, peer-based, behavioral intervention for people with HIV (PWH) in South Africa not on antiretroviral therapy (ART). PWH (43 intervention, 41 controls) completed baseline, 3- and 6-month assessments. TAP was highly feasible (90% completion), with peer counselors demonstrating good intervention fidelity. Post-intervention interviews showed high acceptability of TAP and counselors, who supported autonomy, assisted with clinical navigation, and provided psychosocial support. Intention-to-treat analyses indicated increased ART initiation by 3 months in the intervention vs. control arm (12.2% [5/41] vs. 2.3% [1/43], Fisher exact p-value = 0.105; Cohen's h = 0.41). Among those previously on ART (off for > 6 months), 33.3% initiated ART by 3 months in the intervention vs. 14.3% in the control arm (Cohen's h = 0.45). Results suggest that TAP was highly acceptable and feasible among PWH not on ART.",2020,"We conducted a novel pilot randomized controlled trial of the Treatment Ambassador Program (TAP), an 8-session, peer-based, behavioral intervention for people with HIV (PWH) in South Africa not on antiretroviral therapy (ART).","['South Africans Living with HIV', 'people with HIV (PWH) in South Africa not on antiretroviral therapy (ART']","['Feasible Community-Based Peer Intervention', 'Treatment Ambassador Program (TAP), an 8-session, peer-based, behavioral intervention', 'TAP']",['ART initiation'],"[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",,0.0600254,"We conducted a novel pilot randomized controlled trial of the Treatment Ambassador Program (TAP), an 8-session, peer-based, behavioral intervention for people with HIV (PWH) in South Africa not on antiretroviral therapy (ART).","[{'ForeName': 'Ingrid T', 'Initials': 'IT', 'LastName': 'Katz', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA. ikatz2@bwh.harvard.edu.""}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Bogart', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Garrett M', 'Initials': 'GM', 'LastName': 'Fitzmaurice', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Vincent S', 'Initials': 'VS', 'LastName': 'Staggs', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Marya V', 'Initials': 'MV', 'LastName': 'Gwadz', 'Affiliation': 'Silver School of Social Work, New York University, New York, NY, USA.'}, {'ForeName': 'Ingrid V', 'Initials': 'IV', 'LastName': 'Bassett', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cross', 'Affiliation': 'Desmond Tutu HIV Foundation, University of Cape Town Medical School, Cape Town, South Africa.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Courtney', 'Affiliation': 'Desmond Tutu HIV Foundation, University of Cape Town Medical School, Cape Town, South Africa.'}, {'ForeName': 'Lungiswa', 'Initials': 'L', 'LastName': 'Tsolekile', 'Affiliation': 'School of Public Health, University of the Western Cape, Cape Town, South Africa.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Panda', 'Affiliation': 'Desmond Tutu HIV Foundation, University of Cape Town Medical School, Cape Town, South Africa.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Steck', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Bangsberg', 'Affiliation': 'Oregon Health & Science University-Portland State University School of Public Health, Portland, OR, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Orrell', 'Affiliation': 'Desmond Tutu HIV Foundation, University of Cape Town Medical School, Cape Town, South Africa.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Kansas City, Kansas City, MO, USA.""}]",AIDS and behavior,['10.1007/s10461-020-03063-1']
1561,33126334,The effectiveness and cost-effectiveness of motion style acupuncture treatment (MSAT) for acute neck pain: A multi-center randomized controlled trial.,"BACKGROUND
Neck pain is a common complaint in the general population. Despite the consistent ongoing pain and the resulting economic burden on affected individuals, there have only been a few studies investigating the treatment of acute neck pain. This study aims to evaluate the effectiveness, safety, and cost-effectiveness of the motion style acupuncture treatment (MSAT) and acupuncture treatment for acute neck pain.
METHODS
This 2-armed, parallel, multi-centered randomized controlled trial will be conducted at 4 community-based hospitals in Korea. A total of 128 subjects will be randomly assigned, at a 1:1 ratio, to the MSAT and the acupuncture treatment groups. Treatment will be administered 2 to 3 times a week for 2 weeks. The primary outcome will be the visual analog scale of neck pain on movement. The secondary outcomes will be the numeric rating scale of the neck, neck disability index, Northwick Park questionnaire, patient global impression of change, range of motion of the neck, 5-level EuroQol-5 dimension, 12-item Short-Form Health Survey, and EuroQol visual analogue scale. This protocol has been registered at the Clinicaltrials.gov (NCT04539184).
DISCUSSION
To our knowledge, this study is the first well-designed multi-centered randomized controlled trial to evaluate the effectiveness, safety, and cost-effectiveness of MSAT on acute neck pain. The results of this study will be useful for clinicians in primary medical institutions that frequently treat acute neck pain patients and for policymakers working with national health insurance.",2020,"The secondary outcomes will be the numeric rating scale of the neck, neck disability index, Northwick Park questionnaire, patient global impression of change, range of motion of the neck, 5-level EuroQol-5 dimension, 12-item Short-Form Health Survey, and EuroQol visual analogue scale.","['acute neck pain', '4 community-based hospitals in Korea', '128 subjects']","['motion style acupuncture treatment (MSAT) and acupuncture treatment', 'MSAT', 'motion style acupuncture treatment (MSAT']","['effectiveness, safety, and cost-effectiveness', 'acute neck pain', 'effectiveness and cost-effectiveness', 'numeric rating scale of the neck, neck disability index, Northwick Park questionnaire, patient global impression of change, range of motion of the neck, 5-level EuroQol-5 dimension, 12-item Short-Form Health Survey, and EuroQol visual analogue scale', 'visual analog scale of neck pain on movement']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",128.0,0.250602,"The secondary outcomes will be the numeric rating scale of the neck, neck disability index, Northwick Park questionnaire, patient global impression of change, range of motion of the neck, 5-level EuroQol-5 dimension, 12-item Short-Form Health Survey, and EuroQol visual analogue scale.","[{'ForeName': 'Doori', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation.'}, {'ForeName': 'Yoon Jae', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation.'}, {'ForeName': 'Kyoung Sun', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation.'}, {'ForeName': 'Suna', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Daejeon Jaseng Hospital of Korean Medicine, Seo-gu, Daejeon.'}, {'ForeName': 'Ji-Yeon', 'Initials': 'JY', 'LastName': 'Seo', 'Affiliation': 'Bucheon Jaseng Hospital of Korean Medicine, Bucheon, Gyeonggi-do.'}, {'ForeName': 'Hyun Woo', 'Initials': 'HW', 'LastName': 'Cho', 'Affiliation': 'Haeundae Jaseng Hospital of Korean Medicine, Haeundae-gu, Busan, Republic of Korea.'}, {'ForeName': 'In-Hyuk', 'Initials': 'IH', 'LastName': 'Ha', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation.'}]",Medicine,['10.1097/MD.0000000000022871']
1562,33126335,A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections: Study protocol for the optimal early intervention for cryptococcal antigenemia in HIV-infected patients.,"BACKGROUND
Asymptomatic cryptococcal antigenemia is a state of cryptococcal infection commonly seen in immunocompromised HIV-infected persons. Without early intervention, a proportion of HIV-infected persons with cryptococcal antigenemia may go on to develop cryptococcosis, especially cryptococcal meningitis, which is associated with high mortality. The benefits of antifungal intervention and optimal therapeutic intervention regimens for HIV-infected persons with cryptococcal antigenemia remain controversial. We therefore designed the present study in order to investigate the necessity of, and the optimal regimens for antifungal intervention in the clinical management of cryptococcal antigenemia in HIV-infected populations.
METHODS/DESIGN
This study will be an open-labeled, multi-center, prospective, randomized controlled trial, and 450 eligible participants will be randomized into a control arm and 2 intervention arms at a 1:1:1 ratio, with 150 subjects in each arm. Participants in the control arm will not receive antifungal treatment during the study period. Participants in intervention arm 1 will receive oral fluconazole 800 mg/day for 2 weeks, followed by 400 mg/day for 8 weeks and 200 mg/day for 42 weeks, and participants in intervention arm 2 will receive oral fluconazole 400 mg/day for 52 weeks. The primary outcome is the incidence of CM among the 3 groups during the study period. The secondary outcomes include the differences in all-cause mortality, proportion of patients reverting to blood CrAg negativity, change of CrAg titers, and adverse events among the 3 groups during the follow-up period.
DISCUSSION
We envisage that the results of this study will reveal the necessity of, and the optimal therapeutic regimens for, antifungal intervention in clinical management of HIV-infected patients with cryptococcal antigenemia.
TRIAL REGISTRATION
The study was registered as one of the 12 clinical trials under a general project at the Chinese Clinical Trial Registry on February 1, 2019, and the registration number of the general project is ChiCTR1900021195.",2020,"The secondary outcomes include the differences in all-cause mortality, proportion of patients reverting to blood CrAg negativity, change of CrAg titers, and adverse events among the 3 groups during the follow-up period.
","['HIV-infected patients with cryptococcal antigenemia', 'HIV-infected patients', '450 eligible participants', 'HIV-infected persons with cryptococcal antigenemia remain controversial', 'cryptococcal antigenemia in HIV-infected populations', '12 clinical trials under a general project at the Chinese Clinical Trial Registry on February 1, 2019, and the registration number of the general project is ChiCTR1900021195', 'difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections', 'immunocompromised HIV-infected persons']","['fluconazole', 'antifungal intervention', 'oral fluconazole']","['incidence of CM', 'cause mortality, proportion of patients reverting to blood CrAg negativity, change of CrAg titers, and adverse events']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010415', 'cui_str': 'Cryptococcus'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}]","[{'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0003308', 'cui_str': 'Antifungal-containing product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0451778,"The secondary outcomes include the differences in all-cause mortality, proportion of patients reverting to blood CrAg negativity, change of CrAg titers, and adverse events among the 3 groups during the follow-up period.
","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Xiao-Lei', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Yan-Qiu', 'Initials': 'YQ', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Yao-Kai', 'Initials': 'YK', 'LastName': 'Chen', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022874']
1563,33126364,Evaluation of competence training for the minimally trained health worker in type 2 diabetes: A cluster randomized controlled trial.,"INTRODUCTION
Type 2 diabetes mellitus is responsible for high mortality and morbidity globally and in India. India has high prevalence of the condition and the burden is set to increase exponentially in the next decade. Indians traditionally reside in rural or semi-urban areas with limited access to healthcare facilities. To overcome this, the government has introduced a cadre of health workers called Accredited Social Health Activists (ASHA) for such areas. These workers were initially trained to provide maternal & infant care but now need improved competence training to improve type 2 diabetes screening & management in these locations. The objective of the study is to assess the competence training provided to ASHA workers at the chosen study sites.
METHODOLOGY
A cluster randomized control trial has been designed. It will be conducted across 8 centers in Hyderabad & Rangareddy districts of Telangana, India. The training will be provided to ASHA workers. The tool used for training will be developed from existing sources with an emphasis on topics which require training. The training will be delivered across 6 months at each center as a classroom training. Each participant's baseline competence will be recorded using a questionnaire tool and a practical evaluation by trained public health experts. The same experts will use the same tools to assess the training post the intervention.
DISCUSSION
This trial will evaluate the use of health worker training as a tool for improving the clinical competence in relation to type 2 diabetes mellitus. We anticipate that the module will provide a greater understanding of type 2 diabetes mellitus, the importance of screening of both disease and complications and improved skills for the same. The study has received the ethical approval form the Institutional Ethics Committee of the Indian Institute of Public Health Hyderabad. The registration number is: IIPHH/TRCIEC/218/2020. The trial has also been registered under the Clinical trial registry of India (CTRI) on 27 July 2020. The registration number of the trial is: CTRI/2020/07/026828. The URL of the registry trial is: http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=45342&EncHid=&userName=CTRI/2020/07/026828.",2020,This trial will evaluate the use of health worker training as a tool for improving the clinical competence in relation to type 2 diabetes mellitus.,"['minimally trained health worker in type 2 diabetes', '8 centers in Hyderabad & Rangareddy districts of Telangana, India']","['competence training', 'health worker training']",[],"[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",[],,0.049894,This trial will evaluate the use of health worker training as a tool for improving the clinical competence in relation to type 2 diabetes mellitus.,"[{'ForeName': 'Anirudh Gaurang', 'Initials': 'AG', 'LastName': 'Gudlavalleti', 'Affiliation': 'Indian Institute of Public Health Hyderabad, Public Health Foundation of India, ANV Arcade, 1 Amar Cooperative Society, Kavuri Hills, Madhapur, Hyderabad, India.'}, {'ForeName': 'Giridhara R', 'Initials': 'GR', 'LastName': 'Babu', 'Affiliation': 'Indian Institute of Public Health Hyderabad, Public Health Foundation of India, ANV Arcade, 1 Amar Cooperative Society, Kavuri Hills, Madhapur, Hyderabad, India.'}, {'ForeName': 'Onno C P', 'Initials': 'OCP', 'LastName': 'van Schayck', 'Affiliation': 'CAPHRI CaRE and Public Health Research Institute, Maastricht University, PO Box 616, 6200 MD Maastricht, the Netherlands.'}, {'ForeName': 'Nicolaas C', 'Initials': 'NC', 'LastName': 'Schaper', 'Affiliation': 'CAPHRI CaRE and Public Health Research Institute, Maastricht University, PO Box 616, 6200 MD Maastricht, the Netherlands.'}, {'ForeName': 'Melissa Glenda', 'Initials': 'MG', 'LastName': 'Lewis', 'Affiliation': 'Indian Institute of Public Health Hyderabad, Public Health Foundation of India, ANV Arcade, 1 Amar Cooperative Society, Kavuri Hills, Madhapur, Hyderabad, India.'}, {'ForeName': 'G V S', 'Initials': 'GVS', 'LastName': 'Murthy', 'Affiliation': 'Indian Institute of Public Health Hyderabad, Public Health Foundation of India, ANV Arcade, 1 Amar Cooperative Society, Kavuri Hills, Madhapur, Hyderabad, India.'}]",Medicine,['10.1097/MD.0000000000022959']
1564,33126366,The feasibility and effectiveness of internet-based rehabilitation for patients with knee osteoarthritis: A study protocol of randomized controlled trial in the community setting.,"BACKGROUND
Internet-based rehabilitation can ease the progression of chronic diseases. There had been studies on internet-based rehabilitation of knee osteoarthritis (OA), but them were conducted at home and ignored the potential benefits in the community setting. This study will explore the feasibility and effectiveness of internet-based rehabilitation accompanies wearable devices in the community setting for the patients with knee OA.
METHODS
An assessor-blinded randomized controlled feasibility trial will be performed to study the feasibility and effectiveness of internet-based rehabilitation program for the patients with knee OA in the community setting. Forty participants with knee OA will be recruited and randomly allocated into internet-based rehabilitation group (IRG) or control group (CG). The interventions of IRG will be performed in the community setting via web-based platform and wearable devices. The outcome measures will be conducted at baseline, and post-intervention 6 weeks, 12 weeks during the study. The feasibility will be tested by the proportion of participants who will complete the internet-based rehabilitation program within 12 weeks in IRG as well as the compliance and satisfaction. Additionally, the effectiveness of internet-based rehabilitation will be assessed by the Western Ontario and McMaster Universities Osteoarthritis Index, 11-point Numerical Rating Scale and Short Form-36 quality-of-life questionnaire.
CONCLUSION
The internet-based rehabilitation program and community-based interventions is feasible and efficacy to ameliorate the osteoarthritic pain and promote the physical function and quality of life for the patients with knee OA in the community setting.
TRIAL REGISTRATION NUMBER
The study was registered in the clinical trial registry ChiCTR2000033397.",2020,"The internet-based rehabilitation program and community-based interventions is feasible and efficacy to ameliorate the osteoarthritic pain and promote the physical function and quality of life for the patients with knee OA in the community setting.
","['Forty participants with knee OA', 'patients with knee OA in the community setting', 'patients with knee osteoarthritis', 'patients with knee OA']","['internet-based rehabilitation group (IRG) or control group (CG', 'internet-based rehabilitation', 'internet-based rehabilitation program', 'internet-based rehabilitation program and community-based interventions', 'internet-based rehabilitation accompanies wearable devices']","['Western Ontario and McMaster Universities Osteoarthritis Index, 11-point Numerical Rating Scale and Short Form-36 quality-of-life questionnaire']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}]","[{'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",40.0,0.0575105,"The internet-based rehabilitation program and community-based interventions is feasible and efficacy to ameliorate the osteoarthritic pain and promote the physical function and quality of life for the patients with knee OA in the community setting.
","[{'ForeName': 'Su-Hang', 'Initials': 'SH', 'LastName': 'Xie', 'Affiliation': 'School of Rehabilitation Sciences, West China School of Medicine.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'School of Rehabilitation Sciences, West China School of Medicine.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'School of Rehabilitation Sciences, West China School of Medicine.'}, {'ForeName': 'Si-Yi', 'Initials': 'SY', 'LastName': 'Zhu', 'Affiliation': 'School of Rehabilitation Sciences, West China School of Medicine.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Rehabilitation Sciences, West China School of Medicine.'}, {'ForeName': 'Cheng-Qi', 'Initials': 'CQ', 'LastName': 'He', 'Affiliation': 'School of Rehabilitation Sciences, West China School of Medicine.'}]",Medicine,['10.1097/MD.0000000000022961']
1565,33126867,Randomised prospective phase II trial in multiple brain metastases comparing outcomes between hippocampal avoidance whole brain radiotherapy with or without simultaneous integrated boost: HA-SIB-WBRT study protocol.,"BACKGROUND
Recent evidence supports hippocampal avoidance with whole brain radiotherapy (HA-WBRT) as the recommended treatment option in patients with good prognosis and multiple brain metastases as this results in better neurocognitive preservation compared to whole brain radiotherapy. However, there is often poor tumour control with this technique due to the low doses given. Stereotactic Radiosurgery (SRS), a form of focused radiotherapy which is given to patients who have a limited number of brain metastases, delivers a higher radiation dose to the metastases resulting in better target lesion control. With improvements in radiation technology, advanced dose-painting techniques now allow a simultaneous integrated boost (SIB) dose to lesions whilst minimising doses to the hippocampus to potentially improve brain tumour control and preserve cognitive outcomes. This technique is abbreviated to HA-SIB-WBRT or HA-WBRT+SIB.
METHODS
We hypothesise that the SIB in HA-SIB-WBRT (experimental arm) will result in better tumour control compared to HA-WBRT (control arm). This may also lead to better intracranial disease control as well as functional and survival outcomes. We aim to conduct a prospective randomised phase II trial in patients who have good performance status, multiple brain metastases (4-25 lesions) and a reasonable life expectancy (> 6 months). These patients will be stratified according to the number of brain metastases and randomised between the 2 arms. We aim for a recruitment of 100 patients from a single centre over a period of 2 years. Our primary endpoint is target lesion control. These patients will be followed up over the following year and data on imaging, toxicity, quality of life, activities of daily living and cognitive measurements will be collected at set time points. The results will then be compared across the 2 arms and analysed.
DISCUSSION
Patients with brain metastases are living longer. Maintaining functional independence and intracranial disease control is thus increasingly important. Improving radiotherapy treatment techniques could provide better control and survival outcomes whilst maintaining quality of life, cognition and functional capacity. This trial will assess the benefits and possible toxicities of giving a SIB to HA-WBRT.
TRIAL REGISTRATION
Clinicaltrials.gov identifier: NCT04452084 . Date of registration 30th June 2020.",2020,"With improvements in radiation technology, advanced dose-painting techniques now allow a simultaneous integrated boost (SIB) dose to lesions whilst minimising doses to the hippocampus to potentially improve brain tumour control and preserve cognitive outcomes.","['patients with good prognosis and multiple brain metastases', '100 patients from a single centre over a period of 2\u2009years', 'patients who have good performance status, multiple brain metastases (4-25 lesions) and a reasonable life expectancy (>\u20096\u2009months']","['hippocampal avoidance whole brain radiotherapy with or without simultaneous integrated boost: HA-SIB-WBRT', 'hippocampal avoidance with whole brain radiotherapy (HA-WBRT', 'Stereotactic Radiosurgery (SRS']","['quality of life, cognition and functional capacity', 'imaging, toxicity, quality of life, activities of daily living and cognitive measurements', 'target lesion control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0085203', 'cui_str': 'Radiosurgery'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",100.0,0.0809571,"With improvements in radiation technology, advanced dose-painting techniques now allow a simultaneous integrated boost (SIB) dose to lesions whilst minimising doses to the hippocampus to potentially improve brain tumour control and preserve cognitive outcomes.","[{'ForeName': 'Brendan Seng Hup', 'Initials': 'BSH', 'LastName': 'Chia', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore. brendan.chia.s.h@singhealth.com.sg.'}, {'ForeName': 'Jing Yun', 'Initials': 'JY', 'LastName': 'Leong', 'Affiliation': 'Department of Adult Neuro-developmental Service, Institute of Mental Health Singapore, 10 Buangkok View, Singapore, 539747, Singapore.'}, {'ForeName': 'Ashley Li Kuan', 'Initials': 'ALK', 'LastName': 'Ong', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Lim', 'Affiliation': 'Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.'}, {'ForeName': 'Shi Hui', 'Initials': 'SH', 'LastName': 'Poon', 'Affiliation': 'Department of Psychiatry, Singapore General Hospital, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Melvin Lee Kiang', 'Initials': 'MLK', 'LastName': 'Chua', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.'}, {'ForeName': 'Kevin Lee Min', 'Initials': 'KLM', 'LastName': 'Chua', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kusumawidjaja', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.'}, {'ForeName': 'Eu Tiong', 'Initials': 'ET', 'LastName': 'Chua', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.'}, {'ForeName': 'Fuh Yong', 'Initials': 'FY', 'LastName': 'Wong', 'Affiliation': 'Division of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.'}, {'ForeName': 'Tih Shih', 'Initials': 'TS', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Singapore General Hospital, Outram Road, Singapore, 169608, Singapore.'}]",BMC cancer,['10.1186/s12885-020-07565-y']
1566,33126902,Breath-synchronized electrical stimulation of the expiratory muscles in mechanically ventilated patients: a randomized controlled feasibility study and pooled analysis.,"BACKGROUND
Expiratory muscle weakness leads to difficult ventilator weaning. Maintaining their activity with functional electrical stimulation (FES) may improve outcome. We studied feasibility of breath-synchronized expiratory population muscle FES in a mixed ICU population (""Holland study"") and pooled data with our previous work (""Australian study"") to estimate potential clinical effects in a larger group.
METHODS
Holland: Patients with a contractile response to FES received active or sham expiratory muscle FES (30 min, twice daily, 5 days/week until weaned). Main endpoints were feasibility (e.g., patient recruitment, treatment compliance, stimulation intensity) and safety. Pooled: Data on respiratory muscle thickness and ventilation duration from the Holland and Australian studies were combined (N = 40) in order to estimate potential effect size. Plasma cytokines (day 0, 3) were analyzed to study the effects of FES on systemic inflammation.
RESULTS
Holland: A total of 272 sessions were performed (active/sham: 169/103) in 20 patients (N = active/sham: 10/10) with a total treatment compliance rate of 91.1%. No FES-related serious adverse events were reported. Pooled: On day 3, there was a between-group difference (N = active/sham: 7/12) in total abdominal expiratory muscle thickness favoring the active group [treatment difference (95% confidence interval); 2.25 (0.34, 4.16) mm, P = 0.02] but not on day 5. Plasma cytokine levels indicated that early FES did not induce systemic inflammation. Using a survival analysis approach for the total study population, median ventilation duration and ICU length of stay were 10 versus 52 (P = 0.07), and 12 versus 54 (P = 0.03) days for the active versus sham group. Median ventilation duration of patients that were successfully extubated was 8.5 [5.6-12.2] versus 10.5 [5.3-25.6] days (P = 0.60) for the active (N = 16) versus sham (N = 10) group, and median ICU length of stay was 10.5 [8.0-14.5] versus 14.0 [9.0-19.5] days (P = 0.36) for those active (N = 16) versus sham (N = 8) patients that were extubated and discharged alive from the ICU. During ICU stay, 3/20 patients died in the active group versus 8/20 in the sham group (P = 0.16).
CONCLUSION
Expiratory muscle FES is feasible in selected ICU patients and might be a promising technique within a respiratory muscle-protective ventilation strategy. The next step is to study the effects on weaning and ventilator liberation outcome.
TRIAL REGISTRATION
ClinicalTrials.gov, ID NCT03453944. Registered 05 March 2018-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03453944 .",2020,No FES-related serious adverse events were reported.,"['mechanically ventilated patients', 'Holland', 'Patients with a\xa0contractile response to FES received']","['breath-synchronized expiratory population muscle FES', 'active or sham expiratory muscle FES', 'Breath-synchronized electrical stimulation', 'functional electrical stimulation (FES']","['systemic inflammation', 'Plasma cytokine levels', 'median ventilation duration and ICU length of stay', 'feasibility (e.g., patient recruitment, treatment compliance, stimulation intensity) and safety', 'Median ventilation duration', 'median ICU length of stay', 'serious adverse events', 'total abdominal expiratory muscle thickness']","[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0242800', 'cui_str': 'Patient Recruitment'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",272.0,0.450318,No FES-related serious adverse events were reported.,"[{'ForeName': 'Annemijn H', 'Initials': 'AH', 'LastName': 'Jonkman', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Frenzel', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Euan J', 'Initials': 'EJ', 'LastName': 'McCaughey', 'Affiliation': 'Neuroscience Research Australia, 139 Barker Street, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'Angus J', 'Initials': 'AJ', 'LastName': 'McLachlan', 'Affiliation': 'Liberate Medical LLC, Crestwood, KY, 40014, USA.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Boswell-Ruys', 'Affiliation': 'Neuroscience Research Australia, 139 Barker Street, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Collins', 'Affiliation': 'Prince of Wales Hospital, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Gandevia', 'Affiliation': 'Neuroscience Research Australia, 139 Barker Street, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'Armand R J', 'Initials': 'ARJ', 'LastName': 'Girbes', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Hoiting', 'Affiliation': 'Department of Intensive Care Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Kox', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Oppersma', 'Affiliation': 'Cardiovascular and Respiratory Physiology Group, Technical Medical Centre, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Peters', 'Affiliation': 'Department of Intensive Care Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Lisanne H', 'Initials': 'LH', 'LastName': 'Roesthuis', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Schouten', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Zhong-Hua', 'Initials': 'ZH', 'LastName': 'Shi', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Veltink', 'Affiliation': 'Department of Biomedical Signals and Systems, Technical Medical Centre, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Heder J', 'Initials': 'HJ', 'LastName': 'de Vries', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Cyndi', 'Initials': 'C', 'LastName': 'Shannon Weickert', 'Affiliation': 'Neuroscience Research Australia, 139 Barker Street, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Wiedenbach', 'Affiliation': 'Department of Intensive Care Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Yingrui', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Pieter R', 'Initials': 'PR', 'LastName': 'Tuinman', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Angélique M E', 'Initials': 'AME', 'LastName': 'de Man', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Butler', 'Affiliation': 'Neuroscience Research Australia, 139 Barker Street, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'Leo M A', 'Initials': 'LMA', 'LastName': 'Heunks', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands. L.Heunks@amsterdamumc.nl.'}]","Critical care (London, England)",['10.1186/s13054-020-03352-0']
1567,33126910,Atorvastatin and Aspirin as Adjuvant Therapy in Patients with SARS-CoV-2 Infection: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES
To assess the impact of adding statin (atorvastatin) and/or aspirin on clinical deterioration in patients infected with SARS-CoV-2 who require hospitalisation. The safety of these drugs in COVID-19 patients will also be evaluated.
TRIAL DESIGN
This is a single-centre, prospective, four-arm parallel design, open-label, randomized control trial.
PARTICIPANTS
The study will be conducted at National Cancer Institute (NCI), Jhajjar, Haryana, which is a part of All India Institute of Medical Sciences (AIIMS), New Delhi, and has been converted into a dedicated COVID-19 management centre since the outbreak of the pandemic. All RT-PCR confirmed cases of SARS-CoV-2 infection with age ≥ 40 years and < 75 years requiring hospital admission (patients with WHO clinical improvement ordinal score 3 to 5) will be included in the trial. Written informed consent will be taken for all recruited patients. Patients with a critical illness (WHO clinical improvement ordinal score > 5), documented significant liver disease/dysfunction (aspartate transaminase [AST] / alanine aminotransferase [ALT] > 240), myopathy and rhabdomyolysis (creatine phosphokinase [CPK] > 5x normal), allergy or intolerance to statins or aspirin, prior statin or aspirin use within 30 days, history of active gastrointestinal bleeding in past three months, coagulopathy, thrombocytopenia (platelet count < 100000/ dl), pregnancy, active breastfeeding, or inability to take oral or nasogastric medications will be excluded. Patients refusing to give written consent and taking drugs that are known to have a significant drug interaction with statin or aspirin [including cyclosporine, HIV protease inhibitors, hepatitis C protease inhibitor, telaprevir, fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole), clarithromycin and colchicine] will also be excluded from the trial.
INTERVENTION AND COMPARATOR
In this study, the benefit and safety of atorvastatin (statin) and/or aspirin as adjuvant therapy will be compared with the control group receiving usual care for management of COVID-19. Atorvastatin will be prescribed as 40 mg oral tablets once daily for ten days or until discharge, whichever is earlier. The dose of aspirin will be 75 mg once daily for ten days or until discharge, whichever is earlier. All other therapies will be administered according to the institute's COVID-19 treatment protocol and the treating physician's clinical judgment.
MAIN OUTCOMES
All study participants will be prospectively followed up for ten days or until hospital discharge, whichever is longer for outcomes. The primary outcome will be clinical deterioration characterized by progression to WHO clinical improvement ordinal score ≥ 6 (i.e., endotracheal intubation, non-invasive mechanical ventilation, pressor agents, renal replacement therapy, ECMO requirement, and mortality). The secondary outcomes will be change in serum inflammatory markers (C-reactive protein and Interleukin-6), Troponin I, and creatine phosphokinase (CPK) from time zero to 5th day of study enrolment or 7th day after symptom onset, whichever is later. Other clinical outcomes that will be assessed include progression to Acute Respiratory Distress Syndrome (ARDS), shock, ICU admission, length of ICU admission, length of hospital admission, and in-hospital mortality. Adverse drug effects like myalgia, myopathy, rhabdomyolysis, hepatotoxicity, and bleeding will also be examined in the trial to assess the safety of the interventions.
RANDOMISATION
The study will use a four-arm parallel-group design. A computer-generated permuted block randomization with mixed block size will be used to randomize the participants in a 1:1:1:1 ratio to group A (atorvastatin with conventional therapy), group B (aspirin with conventional therapy), group C (aspirin + atorvastatin with conventional therapy), and group D (control; only conventional therapy).
BLINDING (MASKING)
The study will be an open-label trial.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
As there is no existing study that has evaluated the role of aspirin and atorvastatin in COVID-19 patients, formal sample size calculation has not been done. Patients satisfying the inclusion and exclusion criteria will be recruited during six months of study period. Once the first 200 patients are included in each arm (i.e., total 800 patients), the final sample size calculation will be done on the basis of the interim analysis of the collected data.
TRIAL STATUS
The institutional ethical committee has approved the study protocol (Protocol version 3.0 [June 2020]). Participant recruitment starting date: 28 th July 2020 Participant recruitment ending date: 27 th January 2021 Trial duration: 6 months TRIAL REGISTRATION: The trial has been prospectively registered in Clinical Trial Registry - India (ICMR- NIMS): Reference no. CTRI/2020/07/026791 (registered on 25 July 2020)].
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,All RT-PCR confirmed cases of SARS-CoV-2 infection with age ≥ 40 years and < 75 years requiring hospital admission (patients with WHO clinical improvement ordinal score 3 to 5) will be included in the trial.,"['28 th July 2020 Participant recruitment ending date: 27 th January 2021', 'Patients with SARS-CoV-2 Infection', 'Patients with a critical illness (WHO clinical improvement ordinal score > 5), documented significant liver disease/dysfunction (aspartate transaminase [AST] / alanine aminotransferase [ALT] > 240), myopathy and rhabdomyolysis (creatine phosphokinase [CPK] ', 'patients infected with SARS-CoV-2 who require hospitalisation', 'COVID-19 patients', '200 patients are included in each arm (i.e., total 800 patients']","['statins or aspirin, prior statin or aspirin', 'Atorvastatin and Aspirin', 'aspirin and atorvastatin', 'CTRI/2020/07/026791', 'Atorvastatin', 'statin (atorvastatin) and/or aspirin', 'statin or aspirin [including cyclosporine', 'atorvastatin (statin) and/or aspirin', 'aspirin', 'atorvastatin with conventional therapy), group B (aspirin with conventional therapy), group C (aspirin + atorvastatin with conventional therapy), and group D (control; only conventional therapy', 'fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole), clarithromycin and colchicine']","['serum inflammatory markers (C-reactive protein and Interleukin-6', 'Adverse drug effects like myalgia, myopathy, rhabdomyolysis, hepatotoxicity, and bleeding', 'clinical deterioration characterized by progression to WHO clinical improvement ordinal score ≥ 6 (i.e., endotracheal intubation, non-invasive mechanical ventilation, pressor agents, renal replacement therapy, ECMO requirement, and mortality', 'progression to Acute Respiratory Distress Syndrome (ARDS), shock, ICU admission, length of ICU admission, length of hospital admission, and in-hospital mortality', 'coagulopathy, thrombocytopenia (platelet count < 100000/ dl), pregnancy, active breastfeeding, or inability to take oral or nasogastric medications', 'Troponin I, and creatine phosphokinase (CPK']","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0806020', 'cui_str': 'End date'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0035410', 'cui_str': 'Rhabdomyolysis'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3844106', 'cui_str': '800'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936462', 'cui_str': 'Fibric Acid Derivatives'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0360363', 'cui_str': 'Azole antifungal'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0035410', 'cui_str': 'Rhabdomyolysis'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C4505323', 'cui_str': 'Clinical Deterioration'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0694637', 'cui_str': 'Nasogastric route'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0077401', 'cui_str': 'Troponin I'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}]",800.0,0.175146,All RT-PCR confirmed cases of SARS-CoV-2 infection with age ≥ 40 years and < 75 years requiring hospital admission (patients with WHO clinical improvement ordinal score 3 to 5) will be included in the trial.,"[{'ForeName': 'Nirmal', 'Initials': 'N', 'LastName': 'Ghati', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, 110029, India.'}, {'ForeName': 'Ambuj', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, 110029, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Onco-Anaesthesia, Dr. B.R.A Institute-Rotary Cancer Hospital, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Bhati', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, 110029, India.'}, {'ForeName': 'Sudha', 'Initials': 'S', 'LastName': 'Bhushan', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, 110029, India.'}, {'ForeName': 'Manjit', 'Initials': 'M', 'LastName': 'Mahendran', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, 110029, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Thakur', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, 110029, India.'}, {'ForeName': 'Pawan', 'Initials': 'P', 'LastName': 'Tiwari', 'Affiliation': 'Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Tanima', 'Initials': 'T', 'LastName': 'Dwivedi', 'Affiliation': 'Department of Laboratory Medicine, National Cancer Institute (Jhajjar, Haryana), All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Kalaivani', 'Initials': 'K', 'LastName': 'Mani', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Laboratory Oncology, Dr. B.R.A Institute-Rotary Cancer Hospital, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': 'Department of Onco-Anaesthesia, Dr. B.R.A Institute-Rotary Cancer Hospital, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, 110029, India.'}, {'ForeName': 'Randeep', 'Initials': 'R', 'LastName': 'Guleria', 'Affiliation': 'Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Siddharthan', 'Initials': 'S', 'LastName': 'Deepti', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, 110029, India. deeptikailath@gmail.com.'}]",Trials,['10.1186/s13063-020-04840-y']
1568,33126918,Stuck-moving needle acupuncture myofascial trigger point to treat idiopathic frozen shoulder: study protocol for a randomized controlled trial.,"BACKGROUND
There are evidence for the efficacy of acupuncture treatment for chronic shoulder pain, however, it remains unclear the best acupuncture modes for effective treatment. We compared the effect of the myofascial trigger point (MTrp) stuck-moving needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The aim of present study is to select an effective therapy for patients with idiopathic frozen shoulder.
METHODS
Randomized controlled trial will be conducted in the three clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital, and Qingyang Second People's Hospital in China from February 2020 to January 2021. One hundred and eight frozen shoulder patients will be recruited and randomized into one of three groups in a 1:1:1 ratio of the stuck-moving needle acupuncture group, common acupuncture control group, and physical exercise control group. This trial will include a 1-week baseline period, a 3-week treatment period, and a 12-week follow-up period. During the 3 weeks of the treatment period, patients will receive nine sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and measurement of range of joint motion (ROM) from the baseline period to the 12-week follow-up period. Secondary outcome measures will include measurement of pressure pain threshold (PPT), pressure pain tolerance (PTT), Oxford Shoulder Score (OSS), 36-item short form survey, and patient satisfaction evaluation. Adverse events also will be recorded for safety assessment.
DISCUSSION
The results of this trial will allow us to compare the difference in efficacy between stuck-moving needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals.
TRIAL REGISTRATION
Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). Registered on 22 December 2019. http://www.chictr.org.cn/showproj.aspx?proj=47354.",2020,The primary outcome will be related to change in the Visual Analogue Scale (VAS) and measurement of range of joint motion (ROM) from the baseline period to the 12-week follow-up period.,"['patients with idiopathic frozen shoulder', 'One hundred and eight frozen shoulder patients', ""three clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital, and Qingyang Second People's Hospital in China from February 2020 to January 2021""]","['myofascial trigger point (MTrp) stuck-moving needle acupuncture', 'stuck-moving needle acupuncture group, common acupuncture control group, and physical exercise control group', 'Stuck-moving needle acupuncture myofascial trigger point to treat idiopathic frozen shoulder', 'acupuncture', 'stuck-moving needle acupuncture']","['efficacy and safety', 'pain and range of motions', 'Visual Analogue Scale (VAS) and measurement of range of joint motion (ROM', 'measurement of pressure pain threshold (PPT), pressure pain tolerance (PTT), Oxford Shoulder Score (OSS), 36-item short form survey, and patient satisfaction evaluation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0181956', 'cui_str': 'Acupuncture needle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C2960740', 'cui_str': 'Oxford shoulder score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",108.0,0.133771,The primary outcome will be related to change in the Visual Analogue Scale (VAS) and measurement of range of joint motion (ROM) from the baseline period to the 12-week follow-up period.,"[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, 300073, China.'}, {'ForeName': 'Yinan', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Lei', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Hailong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Jingbao', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Maomao', 'Initials': 'M', 'LastName': 'Cheng', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Shengen', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture and Massage, Qingyang Hospital of Traditional Chinese Medicine, Qingyang, 745000, Gansu, China.'}, {'ForeName': 'Yuan Hao', 'Initials': 'YH', 'LastName': 'Du', 'Affiliation': 'The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China. jpjs_cn@sina.com.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Xia', 'Affiliation': 'The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China. xiatian76@163.com.'}]",Trials,['10.1186/s13063-020-04799-w']
1569,33130414,Effects of the school environment on early sexual risk behavior: A longitudinal analysis of students in English secondary schools.,"INTRODUCTION
The theory of human functioning and school organization proposes that schools promote health by strengthening students' educational engagement. Previous studies have relied on proxy measures of engagement and not examined sexual health. This paper addresses these gaps.
METHODS
Longitudinal data came from the control arm of a randomized trial involving female and male students ages 12-14 in English secondary-schools (n = 3337 students). Exposures measured at baseline included a proxy measure of school-level engagement (value-added education, VAE: the difference between observed absence and attainment rates and those predicted based on student characteristics) and direct measures of school- and student-level engagement (commitment, belonging, relationships and participation). Sexual behavior was measured at 24- and 36-months, including sexual debut and contraception use at first sex.
RESULTS
Higher school-level VAE was associated with an increased risk of early sexual debut at 24-months. Students attending schools with higher overall levels of commitment and belonging were less likely to report sexual debut at 36 months. Students reporting stronger personal commitment to learning and teacher relationships at baseline were less likely to report sexual debut at both follow-up points. Associations involving participation and contraception use were largely nonsignificant.
CONCLUSIONS
Direct measures of the school environment are more strongly associated with reduced sexual risk behavior in early adolescence than the proxy measure, VAE. Results provide some support for the theory and suggest that personal disposition towards school as well as attending a school with high levels of student commitment and belonging are important for subsequent sexual decision making.",2020,Students reporting stronger personal commitment to learning and teacher relationships at baseline were less likely to report sexual debut at both follow-up points.,"['students in English secondary schools', 'Students attending schools with higher overall levels of commitment and belonging were less likely to report sexual debut at 36 months', 'Longitudinal data came from the control arm of a randomized trial involving female and male students ages 12-14 in English secondary-schools (n\xa0=\xa03337 students']",['school environment'],"['proxy measure of school-level engagement (value-added education, VAE: the difference between observed absence and attainment rates and those predicted based on student characteristics) and direct measures of school- and student-level engagement (commitment, belonging, relationships and participation', 'Sexual behavior', 'sexual risk behavior', 'early sexual risk behavior']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0557295', 'cui_str': 'School attendance - finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",3337.0,0.0245885,Students reporting stronger personal commitment to learning and teacher relationships at baseline were less likely to report sexual debut at both follow-up points.,"[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Peterson', 'Affiliation': 'Department of Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, UK. Electronic address: amy.peterson@etr.org.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1H 9SH, UK. Electronic address: elizabeth.allen@lshtm.ac.uk.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Viner', 'Affiliation': 'UCL Great Ormand Street Institute of Child Health, 30 Guilford Street, London WC1N 1EH, UK. Electronic address: r.viner@ucl.ac.uk.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Department of Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, UK. Electronic address: chris.bonell@lshtm.ac.uk.'}]",Journal of adolescence,['10.1016/j.adolescence.2020.10.004']
1570,33130477,"A 12-month, dose-level blinded safety and efficacy study of levodopa inhalation powder (CVT-301, Inbrija) in patients with Parkinson's disease.","INTRODUCTION
CVT-301 (Inbrija™) is a levodopa inhalation powder for on-demand treatment of OFF episodes in Parkinson's disease patients treated with carbidopa/levodopa. Safety and efficacy results of a 12-month, dose-level blinded extension study of a phase 3 trial (SPAN-PD) of CVT-301 are presented.
METHODS
Patients were receiving oral carbidopa/levodopa and adjunctive CVT-301 treatment, blinded to dose (60 mg or 84 mg, N = 325). Study visits occurred every 3 months. Pulmonary function was assessed by spirometry. Other safety assessments included dyskinesia and adverse events (AEs). Secondary objectives of the study included maintenance of improvement assessments for occurrence of an ON state during the 60-min post-dose period, change in total daily OFF time, and Patient Global Impression of Change (PGIC).
RESULTS
Most frequent AEs (≥5%) were cough (15.4%), fall (13.1%), upper respiratory tract infection (7.1%), and dyskinesia (5.1%). Severe AEs (>1 event) were cough (1.9%) and dyskinesia (0.6%). Twelve-month mean changes from baseline for FEV 1 , FVC, and DL CO were -0.092 L, -0.097 L, and -0.922 mL/min/mmHg, respectively. At 12 months, 73.0% of patients on 84 mg achieved an ON state within 60 min. Total daily OFF time was reduced by 0.55 h (month 1) and 0.88 h (month 12) for the 84 mg dose. Percentage of patients self-reported as improved by PGIC was 65.5-91.9% over 12 months.
CONCLUSION
CVT-301 was generally well-tolerated. Twelve-month decline in pulmonary function was consistent with a prior PD control group. Exploratory efficacy results showed CVT-301 maintained improvement at achieving ON states in patients experiencing OFF episodes, decreasing daily OFF time, and maintaining improvement in PGIC.",2020,"Twelve-month mean changes from baseline for FEV 1 , FVC, and DL CO were -0.092 ","[""Parkinson's disease patients treated with"", 'Patients were receiving', ""patients with Parkinson's disease""]","['levodopa inhalation powder (CVT-301, Inbrija', 'carbidopa/levodopa', 'oral carbidopa/levodopa and adjunctive CVT-301 treatment', 'CVT-301 (Inbrija™']","['dyskinesia and adverse events (AEs', 'upper respiratory tract infection', 'daily OFF time, and maintaining improvement in PGIC', 'cough', 'PGIC', 'Safety and efficacy', 'pulmonary function', 'FEV 1 , FVC, and DL CO', 'Total daily OFF time', 'tolerated', 'total daily OFF time, and Patient Global Impression of Change (PGIC', 'Pulmonary function', 'dyskinesia']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C4745728', 'cui_str': 'Levodopa Inhalation Powder'}, {'cui': 'C0240912', 'cui_str': 'Congenital vertical talus'}, {'cui': 'C4745523', 'cui_str': 'Inbrija'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0315546,"Twelve-month mean changes from baseline for FEV 1 , FVC, and DL CO were -0.092 ","[{'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Farbman', 'Affiliation': 'Roseman University of Health Sciences, 5380 South Rainbow Boulevard, Suite 120, Las Vegas, NV, USA. Electronic address: efarbman@roseman.edu.'}, {'ForeName': 'Cheryl H', 'Initials': 'CH', 'LastName': 'Waters', 'Affiliation': 'Columbia University Medical Center, 710 West 168th Street; New York, NY, 10032, USA. Electronic address: cw345@columbia.edu.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'LeWitt', 'Affiliation': 'Department of Neurology, Henry Ford Hospital and Wayne State University School of Medicine, West Bloomfield, MI, 48322, USA. Electronic address: plewitt1@hfhs.org.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Rudzińska', 'Affiliation': 'Department of Neurology, Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Krakow University, Krakow, Poland. Electronic address: mrudzinska@sum.edu.pl.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Klingler', 'Affiliation': 'Acorda Therapeutics, Inc., 420 Saw Mill River Road, Ardsley, NY, 10502, USA. Electronic address: miklingler@gmail.com.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Acorda Therapeutics, Inc., 420 Saw Mill River Road, Ardsley, NY, 10502, USA. Electronic address: angela.lee.ny.10023@gmail.com.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Acorda Therapeutics, Inc., 420 Saw Mill River Road, Ardsley, NY, 10502, USA. Electronic address: Jennyqian01@gmail.com.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Oh', 'Affiliation': 'Acorda Therapeutics, Inc., 420 Saw Mill River Road, Ardsley, NY, 10502, USA. Electronic address: opus99@hotmail.com.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center, University of South Florida, 4001 East Fletcher Ave, 6th Floor, Tampa, FL, 33613, USA. Electronic address: rhauser@usf.edu.""}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.10.029']
1571,33130482,"A randomized study investigating the safety, tolerability, and pharmacokinetics of evinacumab, an ANGPTL3 inhibitor, in healthy Japanese and Caucasian subjects.","BACKGROUND AND AIMS
Evinacumab, an angiopoietin-like protein 3 monoclonal antibody, reduced low-density lipoprotein cholesterol (LDL-C) significantly in a Phase 2 study of patients with homozygous familial hypercholesterolemia. In this double-blind, placebo-controlled Phase 1 study, we compared safety, tolerability, pharmacokinetics, and pharmacodynamics of evinacumab between healthy Japanese and Caucasian adults.
METHODS
Subjects with LDL-C ≥2.6 and <4.1 mmol/L were enrolled to one of four dose cohorts: evinacumab subcutaneous (SC) 300 mg single dose, SC 300 mg once weekly for eight doses, intravenous (IV) 5 mg/kg, or IV 15 mg/kg once every 4 weeks for two doses. Each cohort comprised 24 subjects (12 Japanese; 12 Caucasian), randomized (3:1) to receive evinacumab or placebo within each ethnic group with a 24-week follow-up.
RESULTS
The safety profile of evinacumab (IV and SC) in both ethnicities was comparable with placebo, with no serious or severe treatment-emergent adverse events. Pharmacokinetic profiles were comparable between Japanese and Caucasian subjects across IV and SC groups. Mean calculated LDL-C decreased from baseline with both IV doses, beginning on day 3 up to week 8. Triglyceride changes observed with evinacumab IV were rapid (seen by day 2) and sustained up to week 8. Evinacumab SC doses also reduced LDL-C and triglyceride levels, although lower doses induced smaller changes. Evinacumab (IV and SC) reduced other lipids, including apolipoprotein B, versus placebo.
CONCLUSIONS
In both ethnicities, evinacumab (IV and SC) was generally well tolerated, exhibiting comparable pharmacokinetic profiles. Dose-related reductions in LDL-C and triglycerides were observed with evinacumab in both ethnic groups.",2020,"The safety profile of evinacumab (IV and SC) in both ethnicities was comparable with placebo, with no serious or severe treatment-emergent adverse events.","['healthy Japanese and Caucasian adults', '24 subjects (12 Japanese; 12 Caucasian', 'Subjects with LDL-C ≥2.6 and <4.1\xa0mmol/L were enrolled to one of four dose cohorts', 'healthy Japanese and Caucasian subjects', 'patients with homozygous familial hypercholesterolemia']","['evinacumab subcutaneous (SC) 300\xa0mg single dose, SC', 'evinacumab or placebo', 'Evinacumab (IV and SC', 'Evinacumab SC', 'placebo', 'evinacumab', 'evinacumab (IV and SC']","['safety, tolerability, and pharmacokinetics', 'Mean calculated LDL-C', 'LDL-C and triglyceride levels', 'Pharmacokinetic profiles', 'LDL-C and triglycerides', 'Triglyceride changes', 'safety, tolerability, pharmacokinetics, and pharmacodynamics of evinacumab']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0342881', 'cui_str': 'Familial hypercholesterolemia - homozygous'}]","[{'cui': 'C4508522', 'cui_str': 'evinacumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C4508522', 'cui_str': 'evinacumab'}]",,0.106665,"The safety profile of evinacumab (IV and SC) in both ethnicities was comparable with placebo, with no serious or severe treatment-emergent adverse events.","[{'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Harada-Shiba', 'Affiliation': 'Department of Molecular Innovation in Lipidology, National Cerebral and Cardiovascular Center Research Institute, Suita, Osaka, Japan. Electronic address: mshiba@ncvc.go.jp.'}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Gipe', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Gasparino', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Son', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Alberico L', 'Initials': 'AL', 'LastName': 'Catapano', 'Affiliation': 'Department of Pharmacological and Biomolecular Sciences University of Milan and IRCCS Multimedica, Milan, Italy.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.10.013']
1572,33130569,Study protocol of a pilot study evaluating feasibility and acceptability of a psychosexual intervention for couples postallogeneic haematopoietic stem cell transplantation.,"INTRODUCTION
Sexual dysfunction is one of the most common side effects of allogeneic haematopoietic stem cell transplantation (HSCT) for haematological cancers. Problems can persist between 5 and 10 years post-transplant and impact mood, couple intimacy and relationship satisfaction. Few intervention studies, however, target sexual dysfunction in patients post-HSCT. This pilot study aims to examine the feasibility and acceptability of implementing a psychosexual intervention for HSCT survivors and their partners post-transplantation.
METHODS AND ANALYSIS
Fifteen allogeneic HSCT survivors and their partners will be recruited. Patients who are more than 3 months post-transplantation will be sent invitation letters describing the couples' psychosexual intervention that will be offered through this study. The intervention will comprise two components: (1) psychosexual education about medical and behavioural treatment options for sexual dysfunction delivered by a haematology nurse consultant; (2) emotionally focused therapy-based relationship education programme for couples delivered by a clinical psychologist (four sessions of 1.5 hours each). Couples who consent to participate will be administered a series of measures assessing mood, relationship satisfaction and sexual dysfunction preintervention and post-intervention, as well as satisfaction with the intervention postintervention. Feasibility of the intervention will be examined via recording enrolment rate, adherence, compliance with completing outcome measures and fidelity of intervention delivery.
ETHICS AND DISSEMINATION
Ethics approval has been obtained at the Peter MacCallum Cancer Centre in Melbourne, Australia. Results will be presented at national and international conferences and published in a peer-reviewed journal so that in can be accessed by clinicians involved in the care of allogeneic HSCT patients. If this intervention is found to be feasible and acceptable, its impact will be examined in a future randomised controlled trial and subsequently implemented as part of routine care in the allogeneic HSCT population.",2020,"This pilot study aims to examine the feasibility and acceptability of implementing a psychosexual intervention for HSCT survivors and their partners post-transplantation.
","['Fifteen allogeneic HSCT survivors and their partners will be recruited', 'couples postallogeneic haematopoietic stem cell transplantation', 'Patients who are more than 3 months post-transplantation will be sent invitation letters describing the couples']","['allogeneic haematopoietic stem cell transplantation (HSCT', 'psychosexual education about medical and behavioural treatment options for sexual dysfunction delivered by a haematology nurse consultant; (2) emotionally focused therapy-based relationship education programme for couples delivered by a clinical psychologist', 'psychosexual intervention']",[],"[{'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]","[{'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C1274119', 'cui_str': 'Hematopathology'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0237412', 'cui_str': 'Clinical psychologist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],15.0,0.055046,"This pilot study aims to examine the feasibility and acceptability of implementing a psychosexual intervention for HSCT survivors and their partners post-transplantation.
","[{'ForeName': 'Brindha', 'Initials': 'B', 'LastName': 'Pillay', 'Affiliation': 'Psychosocial Oncology Program, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia brindha.pillay@petermac.org.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ftanou', 'Affiliation': 'Psychosocial Oncology Program, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ritchie', 'Affiliation': 'Department of Clinical Haematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Panek-Hudson', 'Affiliation': 'Department of Clinical Haematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jefford', 'Affiliation': 'Australian Cancer Survivorship Centre, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Garcia', 'Affiliation': 'Department of Clinical Haematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Shields', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Gniel', 'Affiliation': 'Landscape of Life, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Phipps-Nelson', 'Affiliation': 'Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Drosdowsky', 'Affiliation': 'Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Blaschke', 'Affiliation': 'Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Ellen', 'Affiliation': 'Psychosocial Oncology Program, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-039300']
1573,33130890,Memory in low-grade glioma patients treated with radiotherapy or Temozolomide. A correlative analysis of EORTC study 22033-26033.,"BACKGROUND
EORTC study 22033-26033 showed no difference in progression-free survival between high-risk low-grade glioma receiving either radiotherapy (RT) or Temozolomide (TMZ) chemotherapy alone as primary treatment. Considering the potential long-term deleterious impact of radiotherapy on memory functioning, this study aims to determine whether TMZ is associated with less impaired memory functioning.
METHODS
Using the Visual Verbal Learning Test (VVLT), memory functioning was evaluated at baseline and subsequently every 6 months. Minimal compliance for statistical analyses was set at 60%. Conventional indices of memory performance (VVLT Immediate Recall, Total Recall, Learning Capacity, and Delayed Recall) were used as outcome measures. Using a mixed linear model memory functioning was compared between treatment arms and over time.
RESULTS
Neuropsychological assessment was performed in 98 patients ( 53 RT, 46 TMZ). At 12 months compliance had dropped to 66%, restricting analyses to baseline, 6 months, and 12 months. At baseline, patients in either treatment arm did not differ in memory functioning, gender, age, or educational level. Over time, patients in both arms showed improvement in Immediate Recall (p = 0.017) and total number of words recalled (Total Recall; p < 0.001, albeit with delayed improvement in radiotherapy patients (group by time; p = 0.011). Memory functioning was not associated with radiotherapy gross, clinical, or planned target volumes.
CONCLUSION
In patients with high-risk low-grade glioma there is no indication that in the first year after treatment radiotherapy has a deleterious effect on memory function when compared to TMZ chemotherapy.",2020,"Over time, patients in both arms showed improvement in Immediate Recall (p = 0.017) and total number of words recalled (Total Recall; p < 0.001, albeit with delayed improvement in radiotherapy patients (group by time; p = 0.011).","['patients with high-risk low-grade glioma', 'low-grade glioma patients treated with', '98 patients ( 53 RT, 46 TMZ']","['TMZ', 'radiotherapy or Temozolomide', 'radiotherapy', 'radiotherapy (RT) or Temozolomide (TMZ) chemotherapy']","['memory performance (VVLT Immediate Recall, Total Recall, Learning Capacity, and Delayed Recall', 'Visual Verbal Learning Test (VVLT), memory functioning', 'memory functioning, gender, age, or educational level', 'total number of words recalled', 'Memory functioning', 'progression-free survival', 'Immediate Recall']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1997217', 'cui_str': 'Low grade glioma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",98.0,0.12046,"Over time, patients in both arms showed improvement in Immediate Recall (p = 0.017) and total number of words recalled (Total Recall; p < 0.001, albeit with delayed improvement in radiotherapy patients (group by time; p = 0.011).","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Klein', 'Affiliation': 'Brain Tumor Center Amsterdam at Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'A Josephine', 'Initials': 'AJ', 'LastName': 'Drijver', 'Affiliation': 'Brain Tumor Center Amsterdam at Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Jacolien C', 'Initials': 'JC', 'LastName': 'Bromberg', 'Affiliation': 'Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Khê', 'Initials': 'K', 'LastName': 'Hoang-Xuan', 'Affiliation': 'Department of Neurooncology, APHP Hôpitaux Universitaires La Pitié Salpêtrière; Sorbonne Université; Paris, France.'}, {'ForeName': 'Martin J B', 'Initials': 'MJB', 'LastName': 'Taphoorn', 'Affiliation': 'Department of Neurology, Haaglanden Medical Centre, The Hague, the Netherlands.'}, {'ForeName': 'Jaap C', 'Initials': 'JC', 'LastName': 'Reijneveld', 'Affiliation': 'Brain Tumor Center Amsterdam at Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ben Hassel', 'Affiliation': 'Department of Radiation Therapy, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Vauleon', 'Affiliation': 'Department of Radiation Therapy, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Daniëlle B P', 'Initials': 'DBP', 'LastName': 'Eekers', 'Affiliation': 'Department of Radiation Oncology (MAASTRO), GROW - School for Oncology andDevelopmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Tzahala', 'Initials': 'T', 'LastName': 'Tzuk-Shina', 'Affiliation': 'Oncology Institute, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lucas', 'Affiliation': ""Institut Catalá d'Oncologia (ICO), Hospital Duran i Reynals, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Salvador Villà', 'Initials': 'SV', 'LastName': 'Freixa', 'Affiliation': ""Institut Catalá d'Oncologia (ICO), Hospital Duran i Reynals, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Vasilis', 'Initials': 'V', 'LastName': 'Golfinopoulos', 'Affiliation': 'European Organization for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Gorlia', 'Affiliation': 'European Organization for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.'}, {'ForeName': 'Andreas F', 'Initials': 'AF', 'LastName': 'Hottinger', 'Affiliation': 'Departments of Oncology and Clinical Neurosciences, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Stupp', 'Affiliation': 'Departments of Oncology and Clinical Neurosciences, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Brigitta G', 'Initials': 'BG', 'LastName': 'Baumert', 'Affiliation': 'Department of Radiation Oncology (MAASTRO), GROW - School for Oncology andDevelopmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}]",Neuro-oncology,['10.1093/neuonc/noaa252']
1574,33130956,"SAKK 19/17: safety analysis of first-line durvalumab in patients with PD-L1 positive, advanced nonsmall cell lung cancer and a performance status of 2.","INTRODUCTION
The safety of first-line (1L) durvalumab in patients with advanced nonsmall-cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status of 2 (PS2) is unknown. This is an interim unplanned safety analysis of the study SAKK 19/17 for patients with metastatic NSCLC with programmed death-ligand 1 (PD-L1) expression in ≥ 25% of tumor cells and an ECOG PS2 treated with 1L durvalumab. This safety analysis was triggered by the SAKK data and safety monitoring board due to a high mortality rate observed after the recruitment of the first 21 patients.
METHODS
This single-arm phase II study recruited patients with metastatic NSCLC with PD-L1 in ≥ 25% and ECOG PS2. Patients received durvalumab 1500 mg every four weeks. The trial aims to recruit 48 patients in total. This report includes safety analyses only. Adverse events (AEs) were assessed using National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Version 5.0. Efficacy data including the primary endpoint overall survival at 6 months and secondary endpoints (objective response rate, progression-free survival, and quality of life) will be reported at a later time point.
RESULTS
The data from 21 patients were available at this interim safety analysis. Among these, 13 deaths (13/21; 62%) were reported, including one treatment-related fatal colonic perforation at 9 months after treatment initiation (1/13; 8%). Twelve deaths were not treatment-related (12/13; 92%), and mostly attributed to tumor progression (10/13; 77%). Of note, seven deaths (7/13; 54%) occurred during the first 5 weeks (range 0.6-4.7 weeks) after treatment initiation. Four (4/7; 57%) were respiratory failures attributed to tumor progression. One of these patients (25%) had pre-existing COPD, and three (75%) had baseline dyspnea grade 2-3 related to the tumor. Grade ≥ 3 treatment-related AEs (TRAEs) included colonic perforation (grade 5), abdominal pain, and colitis (grade 3 each) in one patient, and fatigue (grade 3) in another. Other Grade ≥ 3 AEs unrelated to treatment were all of pulmonary origin: lung infections (19%), dyspnea (24%), cough (5%), and bronchial obstruction (5%).
CONCLUSIONS
1L durvalumab in patients with ECOG PS2 and metastatic NSCLC with PD-L1 expression ≥ 25% resulted in an unexpectedly high number of fatal early events due to rapid tumor progression. We recommend to avoid treatment with 1 L durvalumab of patients who are highly symptomatic from the tumor, particularly those with respiratory symptoms. The study is continuing its accrual after an amendment excluding these patients.",2020,"Twelve deaths were not treatment-related (12/13; 92%), and mostly attributed to tumor progression (10/13; 77%).","['48 patients in total', 'patients with ECOG PS2 and metastatic NSCLC with PD-L1 expression', 'patients with metastatic NSCLC with programmed death-ligand 1 (PD-L1) expression in\u2009≥\u200925% of tumor cells and an ECOG PS2 treated with 1L durvalumab', 'patients with metastatic NSCLC with PD-L1 in\u2009≥\u200925% and ECOG PS2', 'patients who are highly symptomatic from the tumor, particularly those with respiratory symptoms', 'patients with PD-L1 positive, advanced nonsmall cell lung cancer and a performance status of 2', 'patients with advanced nonsmall-cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status of 2 (PS2']","['first-line (1L) durvalumab', 'durvalumab']","['dyspnea', 'mortality rate', 'Grade\u2009≥\u20093 treatment-related AEs (TRAEs) included colonic perforation (grade 5), abdominal pain, and colitis', 'pre-existing COPD', 'baseline dyspnea grade 2-3 related to the tumor', 'bronchial obstruction', 'overall survival at 6\xa0months and secondary endpoints (objective response rate, progression-free survival, and quality of life', 'fatal colonic perforation', 'National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0347646', 'cui_str': 'Perforation of colon'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0221725', 'cui_str': 'Obstruction of bronchus'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0028275', 'cui_str': 'Terminology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",21.0,0.123342,"Twelve deaths were not treatment-related (12/13; 92%), and mostly attributed to tumor progression (10/13; 77%).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mark', 'Affiliation': 'Department of Medical Oncology/Hematology, Kantonsspital Graubünden, Loestrasse 170, 7000, Chur, Switzerland. michael.mark@ksgr.ch.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Froesch', 'Affiliation': 'Department of Medical Oncology, EOC-Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland.'}, {'ForeName': 'Eric Innocents', 'Initials': 'EI', 'LastName': 'Eboulet', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Addeo', 'Affiliation': 'Department of Oncology, Hôpitaux Universitaires de Genève, Geneva, Switzerland.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Pless', 'Affiliation': 'Department of Medical Oncology, Kantonsspital Winterthur, Winterthur, Switzerland.'}, {'ForeName': 'Sacha I', 'Initials': 'SI', 'LastName': 'Rothschild', 'Affiliation': 'Department of Medical Oncology, Universitätsspital Basel, Basel, Switzerland.'}, {'ForeName': 'Wolf-Dieter', 'Initials': 'WD', 'LastName': 'Janthur', 'Affiliation': 'Department of Medical Oncology, Kantonsspital Aarau, Aargau, Switzerland.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Burmeister', 'Affiliation': 'Department of Medical Oncology, Spital STS AG Thun/Onko-Netz, Thun, Switzerland.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Friedlaender', 'Affiliation': 'Department of Oncology, Hôpitaux Universitaires de Genève, Geneva, Switzerland.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Metaxas', 'Affiliation': 'Department of Medical Oncology/Hematology, Kantonsspital Graubünden, Loestrasse 170, 7000, Chur, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Joerger', 'Affiliation': 'Department of Medical Oncology, Kantonsspital St. Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Wannesson', 'Affiliation': 'Department of Medical Oncology, EOC-Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schwitter', 'Affiliation': 'Department of Medical Oncology/Hematology, Kantonsspital Graubünden, Loestrasse 170, 7000, Chur, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Baudoux', 'Affiliation': 'Department of Oncology, Hôpitaux Universitaires de Genève, Geneva, Switzerland.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Weindler', 'Affiliation': 'Department of Medical Oncology, Kantonsspital St. Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Biaggi-Rudolf', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Früh', 'Affiliation': 'Department of Medical Oncology, Kantonsspital St. Gallen, St Gallen, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Cancer immunology, immunotherapy : CII",['10.1007/s00262-020-02757-8']
1575,33131095,Pharmacodynamics of tegoprazan and revaprazan after single and multiple oral doses in healthy subjects.,"BACKGROUND
Potassium-competitive acid blockers (P-CABs) are emerging as novel treatments for acid-related disorders including gastroesophageal reflux disease. Tegoprazan and revaprazan are approved P-CABs in South Korea, but the pharmacodynamics and safety/tolerability of the two drugs have never been compared.
AIMS
To evaluate the pharmacodynamics and safety/tolerability of tegoprazan and revaprazan after single and multiple oral doses METHODS: A randomised, open-label, active-controlled study was conducted in Helicobacter pylori-negative healthy Korean male subjects. Tegoprazan 50 mg or revaprazan 200 mg was administered orally, once daily for 7 days; 24-h intragastric pH monitoring and serum gastrin were measured for pharmacodynamic evaluation. Safety parameters including serum microRNA-122 (miR-122) level were also collected.
RESULTS
After a singledose, the %Time pH ≥4 for tegoprazan was greater than that for revaprazan (54.5% vs 25.1%). After multiple doses, the %Time pH ≥4 for tegoprazan was much greater than that for revaprazan (68.2% vs 25.3%). %Time pH ≥4 during 12 hours at nighttime for tegoprazan was much greater than that for revaprazan (71.8% vs 31.9%). The changes in the serum gastrin were not clinically significant for either drug. Despite the slight increases of serum miR-122 for each drug, tegoprazan and revaprazan were well tolerated considering other safety parameters including AST and ALT levels.
CONCLUSION
Tegoprazan 50 mg showed stronger gastric acid suppression than revaorazan 200 mg. Both drugs were well tolerated.",2020,"Despite the slight increases of serum miR-122 for each drug, tegoprazan and revaprazan were well tolerated considering other safety parameters including AST and ALT levels.
","['Helicobacter pylori-negative healthy Korean male subjects', 'healthy subjects']","['revaprazan', 'Tegoprazan and revaprazan', 'tegoprazan and revaprazan', 'Potassium-competitive acid blockers (P-CABs', 'Tegoprazan 50\xa0mg or revaprazan', 'revaorazan', 'Tegoprazan']","['serum gastrin', 'Time pH ≥4 for tegoprazan', 'serum miR-122', 'tolerated', 'serum microRNA-122 (miR-122) level', 'gastric acid suppression', 'pharmacodynamics and safety/tolerability']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2699073', 'cui_str': 'Revaprazan'}, {'cui': 'C4726822', 'cui_str': 'tegoprazan'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0428386', 'cui_str': 'Serum gastrin measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4726822', 'cui_str': 'tegoprazan'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017119', 'cui_str': 'Gastric acid'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0348469,"Despite the slight increases of serum miR-122 for each drug, tegoprazan and revaprazan were well tolerated considering other safety parameters including AST and ALT levels.
","[{'ForeName': 'Jung', 'Initials': 'J', 'LastName': 'Sunwoo', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Chun', 'Initials': 'SC', 'LastName': 'Ji', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jaeseong', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Mu Seong', 'Initials': 'MS', 'LastName': 'Ban', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Nam', 'Affiliation': 'Division of Clinical Development, HK inno.N Corp., Seoul, Republic of Korea.'}, {'ForeName': 'Bongtae', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Division of Clinical Development, HK inno.N Corp., Seoul, Republic of Korea.'}, {'ForeName': 'Geun Seog', 'Initials': 'GS', 'LastName': 'Song', 'Affiliation': 'Division of Clinical Development, HK inno.N Corp., Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'In-Jin', 'Initials': 'IJ', 'LastName': 'Jang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16121']
1576,33131164,Effect of vitamin D and/or omega-3 fatty acid supplementation on stroke outcomes: a randomized trial.,"BACKGROUND
Among stroke patients, low serum 25-hydroxyvitamin D (25[OH]D) predicts poor outcomes. In mice, higher omega-3 (n-3) fatty acid intake diminishes brain damage after stroke. However, few studies have examined effects of supplementation with vitamin D or n-3 prior to stroke on post-stroke outcomes.
METHODS
We used data from the VITamin D and OmegA-3 TriaL which randomized middle-aged and older men and women without cardiovascular disease to vitamin D 3 (2000 IU/day) and/or marine n-3 fatty acids (1 g/day) and followed them for incident stroke events. Individuals experiencing a non-fatal stroke were mailed questionnaires assessing functional limitations (the physical performance scale adapted from Nagi) and physical disability (the modified Katz Activities of Daily Living and Rosow-Breslau Functional Health scales). We used logistic regression to analyze associations between randomized treatment and limitations on each scale.
RESULTS
290 individuals experienced their first stroke during the trial. 197 stroke survivors completed the stroke outcomes questionnaire a median of 1.4 years after diagnosis. We observed no associations between randomized treatment to vitamin D and functional limitations (odds ratio [OR]=1.01, 95% confidence interval [CI]: 0.52, 1.97) or physical disability (Rosow-Breslau - OR=0.92, 95% CI: 0.50, 1.67; Katz - OR=1.03, 95% CI: 0.31, 3.42). Those randomized to n-3 had a non-significantly lower risk of functional limitations (OR=0.55, 95% CI: 0.28, 1.09) and physical disability (Rosow-Breslau - OR=0.56, 95% CI: 0.31, 1.02; Katz - OR=0.32, 95% CI: 0.50, 1.67).
CONCLUSION
Vitamin D or omega-3 fatty acids supplementation prior to stroke did not result in significantly improved post-stroke outcomes.",2020,Individuals experiencing a non-fatal stroke were mailed questionnaires assessing functional limitations (the physical performance scale adapted from Nagi) and physical disability (the modified Katz Activities of Daily Living and Rosow-Breslau Functional Health scales).,"['197 stroke survivors', 'Individuals experiencing a non-fatal stroke', '290 individuals experienced their first stroke during the trial', 'middle-aged and older men and women without cardiovascular disease to vitamin D 3 (2000 IU/day) and/or', '1 g/day) and followed them for incident stroke events']","['vitamin D and/or omega-3 fatty acid supplementation', 'omega-3 (n-3) fatty acid intake', 'Vitamin D or omega-3 fatty acids supplementation', 'VITamin D', 'marine n-3 fatty acids', 'vitamin D or n-3']","['physical disability (the modified Katz Activities of Daily Living and Rosow-Breslau Functional Health scales', 'risk of functional limitations', 'stroke outcomes questionnaire', 'stroke outcomes', 'physical disability']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0524645', 'cui_str': 'Marines'}]","[{'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451239', 'cui_str': 'Katz activities of daily living'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",197.0,0.240013,Individuals experiencing a non-fatal stroke were mailed questionnaires assessing functional limitations (the physical performance scale adapted from Nagi) and physical disability (the modified Katz Activities of Daily Living and Rosow-Breslau Functional Health scales).,"[{'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Rist', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rexrode', 'Affiliation': ""Division of Women's Health, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}]",European journal of neurology,['10.1111/ene.14623']
1577,33135429,Treatment effect of lacidipine and amlodipine on clinic and ambulatory blood pressure and arteria stiffness in a randomised double-blind trial.,"PURPOSE
In a randomised, double-blind trial, we investigated effects of lacidipine on clinic and ambulatory blood pressure (BP) and arterial stiffness in patients with mild-to-moderate hypertension, as compared with amlodipine.
MATERIALS AND METHODS
Previously untreated and treated patients ( n = 269, 50-80 years of age) with clinic hypertension (a clinic systolic/diastolic BP 140-180/<110 mmHg and <160/100 mmHg, respectively) were randomly assigned to double-dummy treatment with lacidipine (4-6 mg/day) or amlodipine (5-7.5 mg/day) for 20 weeks. The primary efficacy variable was the change in 24-h ambulatory systolic BP at 20 weeks of treatment. Arterial stiffness was measured as brachial-ankle pulse wave velocity (PWV).
RESULTS
After 20 weeks of treatment, 24-h systolic BP decreased from 141.3 ± 14.0 and 138.3 ± 12.8 mmHg at baseline, respectively, in the lacidipine ( n = 134) and amlodipine groups ( n = 135), by a least square mean (±SE) change of 15.2 ± 1.3 and 15.5 ± 1.3 mmHg, respectively, with a between-group difference (95% confidence interval [CI]) of 0.3 mmHg (-3.4 to 4.1, p = 0.86). Similar results were observed for other ambulatory BP components and clinic BP. Clinic and ambulatory pulse rate did not significantly change in either group ( p ≥ 0.21). PWV decreased significantly ( p < 0.001) from baseline in both groups, with a non-significant between-group difference of 0.24 m/s ( p = 0.45). The incidence rate of adverse events was 30.3% ( n = 40) and 27.5% ( n = 36) in the lacidipine and amlodipine groups, respectively ( p = 0.61). No serious adverse event occurred in the trial.
CONCLUSIONS
Lacidipine effectively lowers clinic and ambulatory BP in patients with mild-to-moderate hypertension and significantly improves arterial stiffness, similarly as amlodipine.",2020,"PWV decreased significantly ( p < 0.001) from baseline in both groups, with a non-significant between-group difference of 0.24 m/s ( p = 0.45).","['patients with mild-to-moderate hypertension', 'Previously untreated and treated patients ( n \u2009=\u2009269, 50-80\u2009years of age) with clinic hypertension (a clinic systolic/diastolic BP 140-180/<110\u2009mmHg and <160/100\u2009mmHg, respectively']","['lacidipine and amlodipine', 'amlodipine', 'lacidipine', 'Lacidipine']","['24-h ambulatory systolic BP', 'brachial-ankle pulse wave velocity (PWV', 'clinic and ambulatory blood pressure (BP) and arterial stiffness', '24-h systolic BP', 'ambulatory BP components and clinic BP', 'Arterial stiffness', 'clinic and ambulatory BP', 'incidence rate of adverse events', 'serious adverse event', 'arterial stiffness', 'Clinic and ambulatory pulse rate', 'clinic and ambulatory blood pressure and arteria stiffness', 'PWV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}]","[{'cui': 'C0064568', 'cui_str': 'lacidipine'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",,0.327021,"PWV decreased significantly ( p < 0.001) from baseline in both groups, with a non-significant between-group difference of 0.24 m/s ( p = 0.45).","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials and Centre for Vascular Evaluations, Shanghai Key Laboratory of Hypertension, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials and Centre for Vascular Evaluations, Shanghai Key Laboratory of Hypertension, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Ji-Guang', 'Initials': 'JG', 'LastName': 'Wang', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials and Centre for Vascular Evaluations, Shanghai Key Laboratory of Hypertension, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}]",Blood pressure,['10.1080/08037051.2020.1840915']
1578,33135436,Is a split-dose intravenous dexamethasone regimen superior to a single high dose in reducing pain and improving function after total hip arthroplasty? A randomized blinded placebo-controlled trial.,"AIMS
Intravenous dexamethasone has been shown to reduce immediate postoperative pain after total hip arthroplasty (THA), though the effects are short-lived. We aimed to assess whether two equivalent perioperative split doses were more effective than a single preoperative dose.
METHODS
A total of 165 patients were randomly assigned into three groups: two perioperative saline injections (Group A, placebo), a single preoperative dose of 20 mg dexamethasone and a postoperative saline injection (Group B), and two perioperative doses of 10 mg dexamethasone (Group C). Patients, surgeons, and staff collecting outcome data were blinded to allocation. The primary outcome was postoperative pain level reported on a ten-point Numerical Rating Scale (NRS) at rest and during activity. The use of analgesic and antiemetic rescue, incidence of postoperative nausea and vomiting (PONV), CRP and interleukin-6 (IL-6) levels, range of motion (ROM), length of stay (LOS), patient satisfaction, and the incidence of surgical site infection (SSI) and gastrointestinal bleeding (GIB) in the three months postoperatively, were also compared.
RESULTS
The pain scores at rest were significantly lower in Groups B and C than in Group A on postoperative days 1 and 2. The dynamic pain scores and CRP and IL-6 levels were significantly lower for Groups B and C compared to Group A on postoperative days 1, 2, and 3. Patients in Groups B and C had a lower incidence of PONV, reduced use of analgesic and antiemetic rescue, improved ROM, shorter LOS, and reported higher satisfaction than in Group A. Patients in Group C had significantly lower dynamic pain scores and IL-6 and CRP levels on postoperative days 2 and 3, and higher ROM and satisfaction on postoperative day 3 than in Group B. No SSI or GIB occurred in any group.
CONCLUSION
Perioperative dexamethasone provides short-term advantages in reducing pain, PONV, and inflammation, and increasing range of motion in the early postoperative period after THA. A split-dose regimen was superior to a single high dose in reducing pain and inflammation, and increasing ROM, with better patient satisfaction. Level of evidence: I Cite this article: Bone Joint J 2020;102-B(11):1497-1504.",2020,"The dynamic pain scores and CRP and IL-6 levels were significantly lower for Groups B and C compared to Group A on postoperative days 1, 2, and 3.",['A total of 165 patients'],"['perioperative saline injections (Group A, placebo', 'dexamethasone', 'placebo', 'dexamethasone and a postoperative saline injection']","['higher satisfaction', 'analgesic and antiemetic rescue, incidence of postoperative nausea and vomiting (PONV), CRP and interleukin-6 (IL-6) levels, range of motion (ROM), length of stay (LOS), patient satisfaction, and the incidence of surgical site infection (SSI) and gastrointestinal bleeding (GIB', 'SSI or GIB', 'pain and inflammation, and increasing ROM', 'ROM and satisfaction', 'pain and improving function', 'dynamic pain scores and CRP and IL-6 levels', 'analgesic and antiemetic rescue, improved ROM, shorter LOS', 'Level of evidence', 'pain, PONV, and inflammation, and increasing range of motion', 'dynamic pain scores and IL-6 and CRP levels', 'pain scores', 'postoperative pain level reported on a ten-point Numerical Rating Scale (NRS) at rest and during activity']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",165.0,0.31205,"The dynamic pain scores and CRP and IL-6 levels were significantly lower for Groups B and C compared to Group A on postoperative days 1, 2, and 3.","[{'ForeName': 'Yiting', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Zeyu', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Fuxing', 'Initials': 'F', 'LastName': 'Pei', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}]",The bone & joint journal,['10.1302/0301-620X.102B11.BJJ-2020-1078.R1']
1579,33135443,Robotic arm-assisted bi-unicompartmental knee arthroplasty maintains natural knee joint anatomy compared with total knee arthroplasty: a prospective randomized controlled trial.,"AIMS
The aim of this study was to compare robotic arm-assisted bi-unicompartmental knee arthroplasty (bi-UKA) with conventional mechanically aligned total knee arthroplasty (TKA) in order to determine the changes in the anatomy of the knee and alignment of the lower limb following surgery.
METHODS
An analysis of 38 patients who underwent TKA and 32 who underwent bi-UKA was performed as a secondary study from a prospective, single-centre, randomized controlled trial. CT imaging was used to measure coronal, sagittal, and axial alignment of the knee preoperatively and at three months postoperatively to determine changes in anatomy that had occurred as a result of the surgery. The hip-knee-ankle angle (HKAA) was also measured to identify any differences between the two groups.
RESULTS
The pre- to postoperative changes in joint anatomy were significantly less in patients undergoing bi-UKA in all three planes in both the femur and tibia, except for femoral sagittal component orientation in which there was no difference. Overall, for the six parameters of alignment (three femoral and three tibial), 47% of bi-UKAs and 24% TKAs had a change of < 2° (p = 0.045). The change in HKAA towards neutral in varus and valgus knees was significantly less in patients undergoing bi-UKA compared with those undergoing TKA (p < 0.001). Alignment was neutral in those undergoing TKA (mean 179.5° (SD 3.2°)) while those undergoing bi-UKA had mild residual varus or valgus alignment (mean 177.8° (SD 3.4°)) (p < 0.001).
CONCLUSION
Robotic-assisted, cruciate-sparing bi-UKA maintains the natural anatomy of the knee in the coronal, sagittal, and axial planes better, and may therefore preserve normal joint kinematics, compared with a mechanically aligned TKA. This includes preservation of coronal joint line obliquity. HKAA alignment was corrected towards neutral significantly less in patients undergoing bi-UKA, which may represent restoration of the pre-disease constitutional alignment (p < 0.001). Cite this article: Bone Joint J 2020;102-B(11):1511-1518.",2020,"The pre- to postoperative changes in joint anatomy were significantly less in patients undergoing bi-UKA in all three planes in both the femur and tibia, except for femoral sagittal component orientation in which there was no difference.",['38 patients who underwent TKA and 32 who underwent'],"['bi-UKA', 'Robotic-assisted, cruciate-sparing bi-UKA', 'total knee arthroplasty', 'conventional mechanically aligned total knee arthroplasty (TKA', 'robotic arm-assisted bi-unicompartmental knee arthroplasty (bi-UKA', 'Robotic arm-assisted bi-unicompartmental knee arthroplasty maintains natural knee joint anatomy']","['hip-knee-ankle angle (HKAA', 'femoral sagittal component orientation', 'change in HKAA towards neutral in varus and valgus knees', 'mild residual varus or valgus alignment', 'pre- to postoperative changes in joint anatomy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C2369992', 'cui_str': 'Align'}, {'cui': 'C0336542', 'cui_str': 'Robotic arm'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}]",,0.0926049,"The pre- to postoperative changes in joint anatomy were significantly less in patients undergoing bi-UKA in all three planes in both the femur and tibia, except for femoral sagittal component orientation in which there was no difference.","[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Banger', 'Affiliation': 'Department of Biomedical Engineering, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Johnston', 'Affiliation': 'Department of Trauma and Orthopaedics, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Razii', 'Affiliation': 'Department of Trauma and Orthopaedics, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Doonan', 'Affiliation': 'Department of Trauma and Orthopaedics, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Rowe', 'Affiliation': 'Department of Biomedical Engineering, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Bryn G', 'Initials': 'BG', 'LastName': 'Jones', 'Affiliation': 'Department of Trauma and Orthopaedics, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Angus D', 'Initials': 'AD', 'LastName': 'MacLean', 'Affiliation': 'Department of Trauma and Orthopaedics, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Mark J G', 'Initials': 'MJG', 'LastName': 'Blyth', 'Affiliation': 'Department of Trauma and Orthopaedics, Glasgow Royal Infirmary, Glasgow, UK.'}]",The bone & joint journal,['10.1302/0301-620X.102B11.BJJ-2020-1166.R1']
1580,33135537,Acute effects of contrast bath on sympathetic skin response in patients with poststroke complex regional pain syndrome.,"PURPOSE
Complex regional pain syndrome (CRPS) is one of the common complications in stroke patients. Sympathetic dysfunction is usually considered underlying pathology. The evidence for contrast bath (CB) used in the treatment of CRPS is limited. The aim of the study is to investigate the possible effects of CB on the sympathetic activity in poststroke CRPS.
MATERIALS AND METHODS
Stroke patients with CRPS (CRPS group) and without CRPS (control group) were included in the study. Age, gender, duration of stroke, aetiology, plegic side, dominant hand, spasticity level, Brunnstrom stages, and comorbidities were recorded. CB was performed for one session to the plegic side of the CRPS and control groups. Sympathetic skin responses (SSR) was recorded from the plegic and healthy hands of participants at pre-CB and post-CB.
RESULTS
Each group consisted of 20 participants. No significant difference was detected in stroke duration, aetiology, and Brunnstrom stages between groups. Elbow spasticity level was significantly higher in CRPS group (p = .034). SSR amplitudes of plegic hands were significantly decreased after CB in CRPS and control groups (p = .0002, p = .013 respectively). Also, CB reduced the SSR amplitude of healty side in CRPS group (p = .003). There was no statistically significant change in SSR latency or percentage changes of SSR amplitude and latency after CB in both groups.
CONCLUSION
CB leads to a significant reduction in sympathetic activity of plegic side of stroke patients. Also, CB to the plegic side has an inhibitory effect on sympathetic activity of healty side in poststroke CRPS. ClinicalTrials.gov ID: NCT04198532.",2020,"SSR amplitudes of plegic hands were significantly decreased after CB in CRPS and control groups (p = .0002, p = .013 respectively).","['patients with poststroke complex regional pain syndrome', 'stroke patients', 'Stroke patients with CRPS (CRPS group) and without CRPS (control group) were included in the study']","['CB', 'contrast bath']","['sympathetic activity', 'Elbow spasticity level', 'SSR amplitudes of plegic hands', 'SSR amplitude and latency', 'Sympathetic skin responses (SSR', 'sympathetic skin response', 'SSR amplitude of healty side', 'SSR latency', 'stroke duration, aetiology, and Brunnstrom stages']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0556915', 'cui_str': 'Contrast water bath hydrotherapy'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",20.0,0.0313681,"SSR amplitudes of plegic hands were significantly decreased after CB in CRPS and control groups (p = .0002, p = .013 respectively).","[{'ForeName': 'Betül', 'Initials': 'B', 'LastName': 'Yavuz Keleş', 'Affiliation': 'University of Health Science Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Önder', 'Affiliation': 'University of Health Science Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Fatma Nur', 'Initials': 'FN', 'LastName': 'Kesiktaş', 'Affiliation': 'University of Health Science Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Kadriye', 'Initials': 'K', 'LastName': 'Öneş', 'Affiliation': 'University of Health Science Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Paker', 'Affiliation': 'University of Health Science Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}]",Somatosensory & motor research,['10.1080/08990220.2020.1830756']
1581,33128939,Rare Functional Variants Associated with Antidepressant Remission in Mexican-Americans: Short title: Antidepressant remission and pharmacogenetics in Mexican-Americans.,"INTRODUCTION
Rare genetic functional variants can contribute to 30-40% of functional variability in genes relevant to drug action. Therefore, we investigated the role of rare functional variants in antidepressant response.
METHOD
Mexican-American individuals meeting the Diagnostic and Statistical Manual-IV criteria for major depressive disorder (MDD) participated in a prospective randomized, double-blind study with desipramine or fluoxetine. The rare variant analysis was performed using whole-exome genotyping data. Network and pathway analyses were carried out with the list of significant genes.
RESULTS
The Kernel-Based Adaptive Cluster method identified functional rare variants in 35 genes significantly associated with treatment remission (False discovery rate, FDR <0.01). Pathway analysis of these genes supports the involvement of the following gene ontology processes: olfactory/sensory transduction, regulation of response to cytokine stimulus, and meiotic cell cycleprocess.
LIMITATIONS
Our study did not have a placebo arm. We were not able to use antidepressant blood level as a covariate. Our study is based on a small sample size of only 65 Mexican-American individuals. Further studies using larger cohorts are warranted.
CONCLUSION
Our data identified several rare functional variants in antidepressant drug response in MDD patients. These have the potential to serve as genetic markers for predicting drug response.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00265291.",2020,"The Kernel-Based Adaptive Cluster method identified functional rare variants in 35 genes significantly associated with treatment remission (False discovery rate, FDR <0.01).","['Mexican-American individuals meeting the Diagnostic and Statistical Manual-IV criteria for major depressive disorder (MDD', '65 Mexican-American individuals', 'MDD patients', 'Mexican-Americans']",['desipramine or fluoxetine'],['Antidepressant remission and pharmacogenetics'],"[{'cui': 'C0025884', 'cui_str': 'Chicanos'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011685', 'cui_str': 'Desipramine'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0031325', 'cui_str': 'Pharmacogenetics'}]",,0.0426557,"The Kernel-Based Adaptive Cluster method identified functional rare variants in 35 genes significantly associated with treatment remission (False discovery rate, FDR <0.01).","[{'ForeName': 'Ma-Li', 'Initials': 'ML', 'LastName': 'Wong', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA; Department of Neuroscience and Physiology, State University of New York, Upstate Medical University, Syracuse, NY, USA; Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia; Department of Psychiatry, Flinders University College of Medicine and Public Health, Bedford Park, South Australia, Australia. Electronic address: wongma@upstate.edu.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Arcos-Burgos', 'Affiliation': 'Grupo de Investigación en Psiquiatría, Departamento de Psiquiatría, Instituto de Investigaciones Médicas, Facultad de Medicina, Universidad de Antioquia, Medellin, Antioquia, Colombia.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia.'}, {'ForeName': 'Alice W', 'Initials': 'AW', 'LastName': 'Licinio', 'Affiliation': 'Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia.'}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia; Department of Psychiatry, Flinders University College of Medicine and Public Health, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Eunice W M', 'Initials': 'EWM', 'LastName': 'Chin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Yao', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA; Department of Neuroscience and Physiology, State University of New York, Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Xin-Yun', 'Initials': 'XY', 'LastName': 'Lu', 'Affiliation': 'Department of Neuroscience & Regenerative Medicine, Medical College of Georgia at Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Stefan R', 'Initials': 'SR', 'LastName': 'Bornstein', 'Affiliation': 'Medical Clinic III, Carl Gustav Carus University Hospital, Dresden University of Technology, Dresden, Germany.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Licinio', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA; Department of Neuroscience and Physiology, State University of New York, Upstate Medical University, Syracuse, NY, USA; Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia; Department of Psychiatry, Flinders University College of Medicine and Public Health, Bedford Park, South Australia, Australia. Electronic address: licinioJ@upstate.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.027']
1582,33129015,Hormonal treatment isolated versus hormonal treatment associated with electrotherapy for pelvic pain control in deep endometriosis: Randomized clinical trial.,"OBJECTIVE
The aim of the study was to evaluate the clinical effectiveness of complementary treatment using self-applied electrotherapy treatment for pain control over the standard hormonal treatment alone for deep infiltrative endometriosis (DIE).
STUDY DESIGN
Multicentre randomized clinical trial. We included a hundred-one participants with DIE in electrotherapy (n = 53) (hormonal treatment + electrotherapy) or control group (n = 48) (only hormonal treatment) by 8 weeks of follow-up. The primary measurement was chronic pelvic pain (CPP) using a visual analogue scale (VAS) and deep dyspareunia. The secondary outcomes were the quality of life by endometriosis health profile (EHP-30) and sexual function by female sexual function index (FSFI).
RESULTS
CPP relief was observed only in the electrotherapy group (pre:7.11 ± 2.40, post:4.55 ± 3.08, p < 0.001). In terms of deep dyspareunia, improvements were observed for both groups (electrotherapy pre:2.02 ± 0.54-1.36 ± 0.96, p < 0.001; control pre:1.95 ± 0.86-1.68 ± 0.82, p = 0.006). Considering the secondary outcomes, a higher total score post-treatment for the EHP-30 was noted in both groups. Regarding sexual function, there was a statistically significant improvement in the FSFI score for the electrotherapy group (p < 0.001), with an increase in the scores for lubrication and pain domains (p = 0.013 and p < 0.001).
CONCLUSIONS
Electrotherapy treatment using transcutaneous electrical nerve stimulation proved to be a good complementary option for pain control, showing benefits in the reduction of CPP and deep dyspareunia and improving patient's quality of life and sexual function.",2020,"Considering the secondary outcomes, a higher total score post-treatment for the EHP-30 was noted in both groups.","['deep endometriosis', 'deep infiltrative endometriosis (DIE', 'hundred-one participants with DIE in electrotherapy (n = 53) (hormonal treatment + electrotherapy) or control group (n = 48) (only hormonal treatment) by 8 weeks of follow-up']","['electrotherapy', 'self-applied electrotherapy treatment']","['CPP relief', 'higher total score post-treatment for the EHP-30', 'quality of life by endometriosis health profile (EHP-30) and sexual function by female sexual function index (FSFI', 'scores for lubrication and pain domains', 'deep dyspareunia', 'chronic pelvic pain (CPP) using a visual analogue scale (VAS) and deep dyspareunia', 'FSFI score']","[{'cui': 'C4510788', 'cui_str': 'Deep endometriosis'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0423747', 'cui_str': 'Deep pain on intercourse'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",1.0,0.0619372,"Considering the secondary outcomes, a higher total score post-treatment for the EHP-30 was noted in both groups.","[{'ForeName': 'Ticiana A A', 'Initials': 'TAA', 'LastName': 'Mira', 'Affiliation': 'School of Medical Sciences, Department of Obstetrics and Gynecology, University of Campinas, Alexander Fleming, 101, Cidade Universitária, Campinas, SP, 13083-881, Brazil. Electronic address: ticiana.mira@gmail.com.'}, {'ForeName': 'Daniela A', 'Initials': 'DA', 'LastName': 'Yela', 'Affiliation': 'School of Medical Sciences, Department of Obstetrics and Gynecology, University of Campinas, Alexander Fleming, 101, Cidade Universitária, Campinas, SP, 13083-881, Brazil. Electronic address: yeladaniela12@gmail.com.'}, {'ForeName': 'Sérgio', 'Initials': 'S', 'LastName': 'Podgaec', 'Affiliation': 'Medical School, Department of Obstetrics and Gynecology, University of São Paulo, Av. Dr. Enéas Carvalho de Aguiar, 255 - Cerqueira César, São Paulo, SP, 05403-000, Brazil. Electronic address: sergiopodgaec@me.com.'}, {'ForeName': 'Edmund C', 'Initials': 'EC', 'LastName': 'Baracat', 'Affiliation': 'Medical School, Department of Obstetrics and Gynecology, University of São Paulo, Av. Dr. Enéas Carvalho de Aguiar, 255 - Cerqueira César, São Paulo, SP, 05403-000, Brazil. Electronic address: ecbaracat@gmail.com.'}, {'ForeName': 'Cristina L', 'Initials': 'CL', 'LastName': 'Benetti-Pinto', 'Affiliation': 'School of Medical Sciences, Department of Obstetrics and Gynecology, University of Campinas, Alexander Fleming, 101, Cidade Universitária, Campinas, SP, 13083-881, Brazil. Electronic address: laguna.unicamp@gmail.com.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.10.018']
1583,33129099,"Nano-curcumin therapy, a promising method in modulating inflammatory cytokines in COVID-19 patients.","BACKGROUND
As an ongoing worldwide health issue, Coronavirus disease 2019 (COVID-19) has been causing serious complications, including pneumonia, acute respiratory distress syndrome (ARDS), and multi-organ failure. However, there is no decisive treatment approach available for this disorder, which is primarily attributed to the large amount of inflammatory cytokine production. We aimed to identify the effects of Nano-curcumin on the modulation of inflammatory cytokines in COVID-19 patients.
METHOD
Forty COVID-19 patients and 40 healthy controls were recruited and evaluated for inflammatory cytokine expression and secretion. Subsequently, COVID-19 patients were divided into two groups: 20 patients receiving Nano-curcumin and 20 patients as the placebo group. The mRNA expression and cytokine secretion levels of IL-1β, IL-6, TNF-α and IL-18 were assessed by Real-time PCR and ELISA, respectively.
RESULT
Our primary results indicated that the mRNA expression and cytokine secretion of IL-1β, IL-6, TNF-α, and IL-18 were increased significantly in COVID-19 patients compared with healthy control group. After treatment with Nano-curcumin, a significant decrease in IL-6 expression and secretion in serum and in supernatant (P = 0.0003, 0.0038, and 0.0001, respectively) and IL-1β gene expression and secretion level in serum and supernatant (P = 0.0017, 0.0082, and 0.0041, respectively) was observed. However, IL-18 mRNA expression and TNF-α concentration were not influenced by Nano-curcumin.
CONCLUSION
Nano-curcumin, as an anti-inflammatory herbal based agent, may be able to modulate the increased rate of inflammatory cytokines especially IL-1β and IL-6 mRNA expression and cytokine secretion in COVID-19 patients, which may cause an improvement in clinical manifestation and overall recovery.",2020,"The mRNA expression and cytokine secretion levels of IL-1β, IL-6, TNF-α and IL-18 were assessed by Real-time PCR and ELISA, respectively.
","['Forty COVID-19 patients and 40 healthy controls', 'COVID-19 patients']","['placebo', 'Nano-curcumin']","['IL-6 expression and secretion in serum and in supernatant', 'mRNA expression and cytokine secretion of IL-1β, IL-6, TNF-α, and IL-18', 'inflammatory cytokine expression and secretion', 'IL-18 mRNA expression and TNF-α concentration', 'mRNA expression and cytokine secretion levels of IL-1β, IL-6, TNF-α and IL-18', 'IL-1β gene expression and secretion level in serum and supernatant']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}]",40.0,0.0296856,"The mRNA expression and cytokine secretion levels of IL-1β, IL-6, TNF-α and IL-18 were assessed by Real-time PCR and ELISA, respectively.
","[{'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Valizadeh', 'Affiliation': 'Tuberculosis and Lung Disease Research Center of Tabriz University of Medical Sciences, Tabriz, Iran; Department of Internal Medicine, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Abdolmohammadi-Vahid', 'Affiliation': ""Student's Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran; Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Danshina', 'Affiliation': 'Department of propaedeutics of dental diseases, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Ziya Gencer', 'Affiliation': 'Department of Family Medicine, Yassawi International Kazakh-Turkish University Hospital, Turkistan, Kazakhstan.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ammari', 'Affiliation': 'Department of Surgery, Mousavi Hospital, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Tuberculosis and Lung Disease Research Center of Tabriz University of Medical Sciences, Tabriz, Iran; Department of Internal Medicine, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Roshangar', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Aslani', 'Affiliation': 'Department of Immunology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Esmaeilzadeh', 'Affiliation': 'Cancer Gene Therapy Research Center (CGRC), Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Ghaebi', 'Affiliation': 'Cancer Gene Therapy Research Center (CGRC), Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Valizadeh', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ahmadi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: ahmadi.m@tbzmed.ac.ir.'}]",International immunopharmacology,['10.1016/j.intimp.2020.107088']
1584,33129156,Worry impairs the problem-solving process: Results from an experimental study.,"INTRODUCTION
Many individuals believe that worry helps solve real-life problems. Some researchers also purport that nonpathological worry can aid problem solving. However, this is in contrast to evidence that worry impairs cognitive functioning.
OBJECTIVE
This was the first study to empirically test the effects of a laboratory-based worry induction on problem-solving abilities.
PROCEDURE
Both high (n = 96) and low (n = 89) trait worriers described a current problem in their lives. They were then randomly assigned to contemplate their problem in a worrisome (n = 60) or objective (n = 63) manner or to engage in a diaphragmatic breathing task (n = 62). All participants subsequently generated solutions and then selected their most effective solution. Next, they rated their confidence in the solution's effectiveness, their likelihood to implement the solution, and their current anxiety/worry. Experimenters uninformed of condition also rated solution effectiveness.
RESULTS
The worry induction led to lower reported confidence in solutions for high trait worry participants, and lower experimenter-rated effectiveness of solutions for all participants, relative to objective thinking. Further, state worry predicted less reported intention to implement solutions, while controlling for trait worry. Finally, worrying about the problem led to more elevated worry and anxiety after solving the problem compared to the other two conditions.
CONCLUSIONS
Overall, the worry induction impaired problem solving on multiple levels, and this was true for both high and low trait worriers.",2020,"Finally, worrying about the problem led to more elevated worry and anxiety after solving the problem compared to the other two conditions.
",[],"['worrisome (n\xa0=\xa060) or objective (n\xa0=\xa063) manner or to engage in a diaphragmatic breathing task', 'laboratory-based worry induction']",['elevated worry and anxiety'],[],"[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",96.0,0.0612885,"Finally, worrying about the problem led to more elevated worry and anxiety after solving the problem compared to the other two conditions.
","[{'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Llera', 'Affiliation': 'Department of Psychology, Towson University, 8000 York Road, Towson, MD, 21252, USA. Electronic address: sllera@towson.edu.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, 140 Moore Building, University Park, PA, 16801, USA. Electronic address: mgn1@psu.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103759']
1585,33135364,Functional Brain Networks: Unique Patterns with Hedonic Appetite and Confidence to Resist Eating in Older Adults with Obesity.,"OBJECTIVE
The purpose of this study was to determine whether baseline measures of hedonic hunger-the Power of Food Scale-and self-control for food consumption-the Weight Efficacy Lifestyle Questionnaire-were associated with network topology within two sets of brain regions (regions of interest [ROIs] 1 and 2) in a group of older adults with obesity. These previously identified brain regions were shown in a different cohort of older adults to be critical for discriminating weight loss success and failure.
METHODS
Baseline functional magnetic resonance imaging data (resting state and food cue task) were collected in a novel cohort of 67 older adults with obesity (65-85 years, BMI = 35-42 kg/m 2 ) participating in an 18-month randomized clinical trial on weight regain.
RESULTS
The Power of Food Scale was most related to ROI 1, which includes the visual cortex and sensorimotor processing areas during only the food cue state. During both the food cue and resting conditions, the Weight Efficacy Lifestyle Questionnaire was associated with ROI 2, which includes areas of the attention network and limbic circuitry.
CONCLUSIONS
Our findings show critical, distinct links between brain network topology with self-reported measures that capture hedonic hunger and the confidence that older adults have in resisting the consumption of food because of both intrapersonal and social/environmental cues.",2020,"The Power of Food Scale was most related to ROI 1, which includes the visual cortex and sensorimotor processing areas during only the food cue state.","['Older Adults with Obesity', 'older adults with obesity', '67 older adults with obesity (65-85 years, BMI\u2009=\u200935-42 kg/m 2 ) participating in an 18-month randomized clinical trial on weight regain']","['functional magnetic resonance imaging data (resting state and food cue task', 'hedonic hunger-the Power of Food Scale-and self-control for food consumption-the Weight Efficacy Lifestyle Questionnaire']",['Weight Efficacy Lifestyle Questionnaire'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",67.0,0.0457075,"The Power of Food Scale was most related to ROI 1, which includes the visual cortex and sensorimotor processing areas during only the food cue state.","[{'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Burdette', 'Affiliation': 'Laboratory for Complex Brain Networks, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Laurienti', 'Affiliation': 'Laboratory for Complex Brain Networks, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Miron', 'Affiliation': 'Laboratory for Complex Brain Networks, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Bahrami', 'Affiliation': 'Laboratory for Complex Brain Networks, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Sean L', 'Initials': 'SL', 'LastName': 'Simpson', 'Affiliation': 'Laboratory for Complex Brain Networks, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': 'Section on Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fanning', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Section on Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.23004']
1586,33129261,A three-armed cognitive-motor exercise intervention to increase spatial orientation and life-space mobility in nursing home residents: study protocol of a randomized controlled trial in the PROfit project.,"BACKGROUND
In nursing home residents, the combination of decreasing mobility and declining cognitive abilities, including spatial orientation, often leads to reduced physical activity (PA) and life-space (LS) mobility. As a consequence of sedentary behavior, there is a lack of social interaction and cognitive stimulation, resulting in low quality of life. It has not yet been examined whether cognitive-motor training including spatial cognitive tasks is suitable to improve spatial orientation and, as a consequence, to enlarge LS mobility, and increase well-being and general cognitive-motor functioning. Therefore, the overall goal of this multicentric randomized controlled trial (RCT) is to compare the effect of three different intervention approaches including functional exercise and orientation tasks on PA, LS and spatial orientation in nursing home residents.
METHODS
A three-arm single-blinded multicenter RCT with a wait-list control group will be conducted in a sample of 513 individuals (needed according to power analysis) in three different regions in Germany. In each nursing home, one of three different intervention approaches will be delivered to participating residents for 12 weeks, twice a week for 45 min each: The PROfit basic group will perform functional strength, balance, flexibility, and walking exercises always at the same location, whereas the PROfit plus group changes the location three times while performing similar/the same exercises as the PROfit basic group. The PROfit orientation group receives navigation tasks in addition to the relocation during the intervention. Physical and cognitive functioning as well as psychological measures will be assessed in all study groups at baseline. Participants will then be randomized into either the intervention group or the wait-list control group. After 12 weeks, and after 24 weeks the measures will be repeated.
DISCUSSION
This study evaluates whether the three different interventions are feasible to reduce the decline of or even improve PA, LS, and spatial orientation in nursing home residents. By adding different training locations in PROfit plus, the program is expected to be superior to PROfit basic in increasing physical and cognitive parameters. Moreover, we expect the PROfit orientation intervention to be most effective in terms of PA, LS, and spatial orientation due to two mechanisms: (1) increased physical and cognitive activity will enhance cognitive-motor capacity and (2) the spatial training will help to build up cognitive strategies to compensate for age-related loss of spatial orientation abilities and related limitations.
TRIAL REGISTRATION
The trial was prospectively registered at DRKS.de with registration number DRKS00021423 on April 16, 2020 and was granted permission by the Technical University Berlin local ethics committee (No. GR_14_20191217).",2020,"By adding different training locations in PROfit plus, the program is expected to be superior to PROfit basic in increasing physical and cognitive parameters.","['513 individuals (needed according to power analysis) in three different regions in Germany', 'nursing home residents']","['PROfit plus group changes the location three times while performing similar/the same exercises as the PROfit basic group', 'functional exercise and orientation tasks', 'wait-list control group', 'cognitive-motor exercise intervention']","['Physical and cognitive functioning', 'physical activity (PA) and life-space (LS) mobility', 'spatial orientation and life-space mobility']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0037744', 'cui_str': 'Space Perception'}]",,0.0406414,"By adding different training locations in PROfit plus, the program is expected to be superior to PROfit basic in increasing physical and cognitive parameters.","[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Wollesen', 'Affiliation': 'Department of Biological Psychology and Neuroergonomics, TU Berlin, Fasanenstr. 1, 10623, Berlin, Germany. bettina.wollesen@uni-hamburg.de.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Fricke', 'Affiliation': 'Department of Biological Psychology and Neuroergonomics, TU Berlin, Fasanenstr. 1, 10623, Berlin, Germany.'}, {'ForeName': 'Carl-Philipp', 'Initials': 'CP', 'LastName': 'Jansen', 'Affiliation': 'Network Aging Research, Heidelberg University, Bergheimer Str. 20, 69115, Heidelberg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Gordt', 'Affiliation': 'Institute of Sports and Sports Sciences, Heidelberg University, Im Neuenheimer Feld 720, 69120, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schwenk', 'Affiliation': 'Network Aging Research, Heidelberg University, Bergheimer Str. 20, 69115, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Muehlbauer', 'Affiliation': 'Division of Movement and Training Sciences/Biomechanics of Sport, University of Duisburg-Essen, Gladbecker Str. 182, 45141, Essen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Morawietz', 'Affiliation': 'Division of Movement and Training Sciences/Biomechanics of Sport, University of Duisburg-Essen, Gladbecker Str. 182, 45141, Essen, Germany.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Kruse', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Gramann', 'Affiliation': 'Department of Biological Psychology and Neuroergonomics, TU Berlin, Fasanenstr. 1, 10623, Berlin, Germany.'}]",BMC geriatrics,['10.1186/s12877-020-01840-0']
1587,33129289,Comparison of oral Nano-Curcumin with oral prednisolone on oral lichen planus: a randomized double-blinded clinical trial.,"BACKGROUND
Oral lichen planus (OLP) is a mucocutaneous autoimmune disease with T-cell mediation. Corticosteroids are considered as a first choice in OLP and should be used for a long period with a subsequent increase in dose since the disease has a chronic and recalcitrant nature. There have been efforts to use alternative therapies due to the Corticosteroid's side effects. Curcumin is a non-toxic natural product with different effects on various oral diseases. It demonstrates antioxidant, anti-inflammatory, antimicrobial, and anticarcinogenic activities. It seems that Curcumin can be used as a proper alternative for Corticosteroid treatments. To overcome limitations in the bioavailability of Curcumin, the therapeutic effect of oral Nano-Curcumin was evaluated for the first time.
METHODS
Sixty OLP patients were included in this double-blinded randomized clinical trial. The patients were randomly divided into two groups and received either 'Nano-Curcumin 80 mg' or 'Prednisolone 10 mg' treatments for 1 month. The patients should take one capsule after having their breakfast. The VAS scale was used to analyze pain severity and burning sensation. To assess lesion size the Thongprasom scale was employed. Repeated measures and independent t-tests, as well as LSD paired-test, were used to analyze the data.
RESULTS
Data from 57 patients were analyzed. The level of pain, burning sensation, and OLP lesions decreased in both groups of Curcumin and Prednisolone and no statistically significant difference was observed between the two groups.
CONCLUSION
Despite many studies conducted to find an effective approach for managing OLP, the results have often been unsatisfactory. In comparison with previous studies, current results clarify the importance of Nano-Curcumin bioavailability in therapeutic effects. Pain VAS and lesion size were decreased with oral Curcumin. The results have shown that oral Curcumin can be used as an alternative therapy for OLP in patients with the contraindicated Corticosteroids or should be used with caution. Oral Curcumin can be used in preventing the recurrence of OLP lesions after the treatment and initial control. Moreover, the amount of Curcumin dose is more important than its use duration in improving OLP.
TRIAL REGISTRATION
IRCT, IRCT20100101002950N5. Registered 9 February 2019, https://www.irct.ir/trial/36704 .",2020,"The level of pain, burning sensation, and OLP lesions decreased in both groups of Curcumin and Prednisolone and no statistically significant difference was observed between the two groups.
","['Sixty OLP patients', 'oral lichen planus', '57 patients were analyzed']","['Prednisolone', 'Corticosteroids', ""Nano-Curcumin 80 mg' or 'Prednisolone"", 'Oral Curcumin', 'oral Nano-Curcumin with oral prednisolone']","['VAS scale', 'Pain VAS and lesion size', 'level of pain, burning sensation, and OLP lesions', 'pain severity and burning sensation', 'recurrence of OLP lesions']","[{'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",57.0,0.0542584,"The level of pain, burning sensation, and OLP lesions decreased in both groups of Curcumin and Prednisolone and no statistically significant difference was observed between the two groups.
","[{'ForeName': 'Seyed Javad', 'Initials': 'SJ', 'LastName': 'Kia', 'Affiliation': 'Dental sciences research center, Department of Oral and Maxillofacial Medicine, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Basirat', 'Affiliation': 'Dental sciences research center, Department of Oral and Maxillofacial Medicine, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Mortezaie', 'Affiliation': 'Dental sciences research center, Department of Oral and Maxillofacial Medicine, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Mahdieh-Sadat', 'Initials': 'MS', 'LastName': 'Moosavi', 'Affiliation': 'Dental Research Center, Dentistry Research Institute, Department of Oral and Maxillofacial Medicine, Faculty of Dentistry, Tehran University of Medical Sciences, Tehran, Iran. ms-moosavi@sina.tums.ac.ir.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-03128-7']
1588,33129360,First-line support for assistance in breathing in children: statistical and health economic analysis plan for the FIRST-ABC trial.,"BACKGROUND
The FIRST-ABC trial comprises of two pragmatic, multicentre, parallel groups, non-inferiority randomised clinical trials designed to evaluate the clinical non-inferiority of first-line use of high flow nasal cannula (HFNC) to continuous positive airway pressure (CPAP) in critically ill children who require non-invasive respiratory support (NRS).
OBJECTIVES
To describe the pre-specified statistical and health economic analysis for the FIRST-ABC trial before completion of patient recruitment and data collection.
METHODS
The statistical analysis plan was designed by the chief investigators and statisticians. We define the primary and secondary outcomes, summarise methods for data collection and safety monitoring, and present a detailed description of the planned statistical and health economic analysis.
RESULTS
The primary clinical outcome is time to liberation from respiratory support. The primary effect estimate will be the adjusted hazard ratio, reported with a 95% confidence interval. As a sensitivity analysis, the primary analysis will be repeated using time to start weaning of NRS. Subgroup analyses will be performed to test for interactions between the effect of allocated treatment group and pre-specified baseline covariates. The health economic analysis will follow the intention-to-treat principle and report the mean (95% confidence interval) incremental costs, quality-adjusted life years (QALYs) and cost-effectiveness up to 6 months. All analyses will be performed separately for each of the two trials, and any results will not be combined.
CONCLUSION
The FIRST-ABC trial will assess the non-inferiority of HFNC compared to CPAP in two parallel trials with shared infrastructure (step-up RCT and step-down RCT). We have developed a pre-specified statistical and health economics analysis plan for the FIRST-ABC study before trial completion to minimise analytical bias.
TRIAL REGISTRATION
ISRCTN ISRCTN60048867 . Registered on 19 June 2019.",2020,The FIRST-ABC trial will assess the non-inferiority of HFNC compared to CPAP in two parallel trials with shared infrastructure (step-up RCT and step-down RCT).,"['children', 'critically ill children who require non-invasive respiratory support (NRS']",['high flow nasal cannula (HFNC) to continuous positive airway pressure (CPAP'],"['incremental costs, quality-adjusted life years (QALYs) and cost-effectiveness', 'time to liberation from respiratory support']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",,0.26679,The FIRST-ABC trial will assess the non-inferiority of HFNC compared to CPAP in two parallel trials with shared infrastructure (step-up RCT and step-down RCT).,"[{'ForeName': 'Izabella', 'Initials': 'I', 'LastName': 'Orzechowska', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, 24 High Holborn, London, WC1V 6AZ, UK. izabella.orzechowska@icnarc.org.'}, {'ForeName': 'M Zia', 'Initials': 'MZ', 'LastName': 'Sadique', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, 24 High Holborn, London, WC1V 6AZ, UK. Karen.Thomas@icnarc.org.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Davis', 'Affiliation': 'Paediatric Intensive Care, Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Upper Maudlin Street, Bristol, BS2 8BJ, UK.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Morris', 'Affiliation': ""Paediatric Intensive Care, Birmingham Children's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Steelhouse Lane, Birmingham, B4 6NH, UK.""}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, 24 High Holborn, London, WC1V 6AZ, UK.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Peters', 'Affiliation': 'Paediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Foundation Trust, and NIHR Biomedical Research Centre, London, WC1N 3JH, UK.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Richards-Belle', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, 24 High Holborn, London, WC1V 6AZ, UK.'}, {'ForeName': 'Lyvonne N', 'Initials': 'LN', 'LastName': 'Tume', 'Affiliation': 'School of Health & Society, University of Salford, Mary Seacole Building, Frederick Road Campus, Broad St, Salford, M6 6PU, UK.'}, {'ForeName': 'Padmanabhan', 'Initials': 'P', 'LastName': 'Ramnarayan', 'Affiliation': ""Children's Acute Transport Service, Great Ormond Street Hospital for Children NHS Foundation Trust and NIHR Biomedical Research Centre, London, WC1N 3JH, UK.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), Napier House, 24 High Holborn, London, WC1V 6AZ, UK.'}]",Trials,['10.1186/s13063-020-04818-w']
1589,33129363,A Trial of Favipiravir and Hydroxychloroquine combination in Adults Hospitalized with moderate and severe Covid-19: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES
The selected combination was based on limited evidence clinically and in vitro on the efficacy of the Favipiravir and Hydroxychloroquine in SARS-CoV-2. The two medications were listed in many guidelines as treatment options and ongoing trials assessing their efficacy and safety. Thus, we want to prove the clinical effectiveness of the combination as therapy.
TRIAL DESIGN
This is an Open label, multicenter, randomized controlled clinical trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. It is a multicenter trial that will compare Favipiravir plus Hydroxychloroquine combination (experimental arm) to a control arm.
PARTICIPANTS
All study procedures will be conducted in eight centres in Saudia Arabia: King Abdulaziz Medical City National Guard Health Affairs in Riyadh. King Abdulaziz Hospital - Al Ahsa, Saudi Arabia AlMadina General Hospital, Madnia, Saudi Arabia Al-Qatif Central Hospital, Saudi Arabia Imam Abdulrahman Al Faisal Hospital, Dammam, Saudi Arabia King Abdulaziz Medical City, Jeddah, Saudi Arabia King Abdulaziz Hospital, Makkah, Saudi Arabia Imam Abdulrahman Alfaisal Hospital, Riyadh, Saudi Arabia Inclusion Criteria • Should be at least 18 years of age, • Male or nonpregnant female, • Diagnosed with COVID-19 by PCR confirmed SARS-coV-2 viral infection. • Able to sign the consent form and agree to clinical samples collection (or their legal surrogates if subjects are or become unable to make informed decisions).. • Moderate or Severe COVID-19, defined as oxygen saturation (Sao2) of 94% or less while they were breathing ambient air or significant clinical symptoms that require hospital admission. • patients had to be enrolled within 10 days of disease onset. Exclusion Criteria • Patients who are pregnant or breastfeeding. • Will be transferred to a non-study site hospital or discharged from hospital within 72 hours. • Known sensitivity/allergy to hydroxychloroquine or Favipiravir • Current use of hydroxychloroquine for another indication • Prior diagnosis of retinopathy • Prior diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency • Major comorbidities increasing the risk of study drug including: i. Hematologic malignancy, ii. Advanced (stage 4-5) chronic kidney disease or dialysis therapy, iii. Known history of ventricular arrhythmias, iv. Current use of drugs that prolong the QT interval, Severe liver damage (Child-Pugh score ≥ C, AST> 5 times the upper limit), HIV. • The investigator believes that participating in the trial is not in the best interests of the patient, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues). • Clinical prognostic non-survival, palliative care, or in deep coma and no have response to supportive treatment within three hours of admission • Patient with irregular rhythm • Patient with a history of heart attack (myocardial infarction) • Patient with a family history of sudden death from heart attack before the age of 50 • Take other drugs that can cause prolonged QT interval • Patient who is receiving immunosuppressive therapy (cyclosporin) which cannot be switched to another agent or adjusted while using the investigational drug • Gout/history of Gout or hyperuricemia (above the ULN), hereditary xanthinuria or xanthine calculi of the urinary tract.
INTERVENTION AND COMPARATOR
The treatment intervention would be for a maximum of 10 days from randomization and it would be as follows: Favipiravir for 10 days: Administer 1800 mg (9 tablets) by mouth twice daily for one day, followed by 800mg (4 tablets) twice daily (total days of therapy is 10 days) Hydroxychloroquine for 5 days: (400mg) twice daily on day 1; for days 2-5 (200mg) twice daily. Reference Comparator Therapy: Standard of care is defined as: Treatment that is accepted by medical experts as a proper treatment for Covid-19 disease. Standard care comprised of, as necessary, supplemental oxygen, noninvasive and invasive ventilation, antibiotic agents, vasopressor support, renal-replacement therapy, extracorporeal membrane oxygenation (ECMO), and antiviral therapy except Favipiravir. Also, it may include intravenous fluids and medications for symptoms relief .
MAIN OUTCOMES
The primary endpoint is the time to clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first (14 days from Randomization).
RANDOMISATION
Eligible participants will be randomized in a 1:1 ratio to either the combination group (Favipiravir and Hydroxychloroquine) or a control group. The patients will be randomized utilizing Web based data entry System with a stratification based on the centre and the ICU admission.
BLINDING (MASKING)
This is an Open label study and only the analyst will be blinded during the study conduct.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
Under the classical two arm parallel design the total effective sample sizes needed is 472 subjects (236 subjects per group).
TRIAL STATUS
Protocol version 3.1 (dated 11 Aug 2020), and currently recruitment is ongoing. The date recruitment started was May 21, 2020 and the investigators anticipate the trial will finish recruiting by the end of December 2020.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04392973 , 19 May 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
Under the classical two arm","['Patient with irregular rhythm •', 'Patient with a history of heart attack (myocardial infarction) •', 'hospitalized adults diagnosed with COVID-19', 'Favipiravir for 10 days', 'Patient with a family history of sudden death from heart attack before the age of 50 •', 'Advanced (stage 4-5) chronic kidney disease or dialysis therapy, iii', '• patients had to be enrolled within 10 days of disease onset', 'Male or nonpregnant female, •', 'All study procedures will be conducted in eight centres in Saudia Arabia: King Abdulaziz Medical City National Guard Health Affairs in Riyadh', 'Exclusion Criteria • Patients who are pregnant or breastfeeding', 'Adults Hospitalized with moderate and severe Covid-19', '472 subjects (236 subjects per group']","['hydroxychloroquine', 'Favipiravir and Hydroxychloroquine combination', 'Hydroxychloroquine', 'Favipiravir and Hydroxychloroquine', 'combination group (Favipiravir and Hydroxychloroquine', 'Favipiravir plus Hydroxychloroquine', 'immunosuppressive therapy (cyclosporin', 'supplemental oxygen, noninvasive and invasive ventilation, antibiotic agents, vasopressor support, renal-replacement therapy, extracorporeal membrane oxygenation (ECMO), and antiviral therapy except Favipiravir', 'Favipiravir •']","['time to clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first', 'efficacy and safety', 'safety and efficacy', 'QT interval, Severe liver damage (Child', 'QT interval •', 'oxygen saturation (Sao2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205271', 'cui_str': 'Irregular'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2315244', 'cui_str': 'Family history of sudden death'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011946', 'cui_str': 'Dialysis procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0277793', 'cui_str': 'Onset of illness'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0003671', 'cui_str': 'Arabia'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0278253', 'cui_str': 'Guarded prognosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0151763', 'cui_str': 'Liver damage'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",,0.110357,"NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
Under the classical two arm","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bosaeed', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Riyadh, Saudi Arabia. Dr.bosaeed@live.com.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alharbi', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdulrahman', 'Initials': 'A', 'LastName': 'Alsaedy', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Alothman', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Majed', 'Initials': 'M', 'LastName': 'Aljeraisy', 'Affiliation': 'King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Alqahtani', 'Affiliation': 'Pharmaceutical Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Nashabat', 'Affiliation': 'King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Badriah', 'Initials': 'B', 'LastName': 'Almutairi', 'Affiliation': 'King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Manar', 'Initials': 'M', 'LastName': 'Almaghaslah', 'Affiliation': 'Department of Medicine, King Abdulaziz Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Aldibasi', 'Affiliation': 'King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'AlJohani', 'Affiliation': 'College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abderrezak', 'Initials': 'A', 'LastName': 'Bouchama', 'Affiliation': 'King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Yaseen', 'Initials': 'Y', 'LastName': 'Arabi', 'Affiliation': 'College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alaskar', 'Affiliation': 'College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}]",Trials,['10.1186/s13063-020-04825-x']
1590,33129376,"Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial.","BACKGROUND
Venetoclax is a highly selective, potent, oral BCL-2 inhibitor, which induces apoptosis in multiple myeloma cells. Venetoclax plus bortezomib and dexamethasone has shown encouraging clinical efficacy with acceptable safety and tolerability in a phase 1 trial. The aim of this study was to evaluate venetoclax plus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma.
METHODS
In this randomised, double-blind, multicentre, phase 3 trial, patients aged 18 years or older with relapsed or refractory multiple myeloma, an Eastern Cooperative Oncology Group performance status of 2 or less, who had received one to three previous therapies were enrolled from 90 hospitals in 16 countries. Eligible patients were randomly assigned (2:1) centrally using an interactive response technology system and a block size of three to receive venetoclax (800 mg per day orally) or placebo with bortezomib (1·3 mg/m 2 subcutaneously or intravenously and dexamethasone (20 mg orally). Treatment was given in 21-day cycles for the first eight cycles and 35-day cycles from the ninth cycle until disease progression, unacceptable toxicity, or patient withdrawal. Randomisation was stratified by previous exposure to a proteasome inhibitor and the number of previous therapies. Sponsors, investigators, study site personnel, and patients were masked to the treatment allocation throughout the study. The primary endpoint was independent review committee-assessed progression-free survival in the intention-to-treat population. Safety analyses were done in patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT02755597.
FINDINGS
Between July 19, 2016, and Oct 31, 2017, 291 patients were randomly assigned to receive venetoclax (n=194) or placebo (n=97). With a median follow-up of 18·7 months (IQR 16·6-21·0), median progression-free survival according to independent review committee was 22·4 months (95% CI 15·3-not estimable) with venetoclax versus 11·5 months (9·6-15·0) with placebo (hazard ratio [HR] 0·63 [95% CI 0·44-0·90]; p=0·010). The most common grade 3 or worse treatment-emergent adverse events were neutropenia (35 [18%] of 193 patients in the venetoclax group vs seven [7%] of 96 patients in the placebo group), pneumonia (30 [16%] vs nine [9%]), thrombocytopenia (28 [15%] vs 29 [30%]), anaemia (28 [15%] vs 14 [15%]), and diarrhoea (28 [15%] vs 11 [11%]). Serious treatment-emergent adverse events occurred in 93 (48%) patients in the venetoclax group and 48 (50%) patients in the placebo group, with eight (4%) treatment-emergent fatal infections reported in the venetoclax group and none reported in the placebo group. Three deaths in the venetoclax group (two from pneumonia and one from septic shock) were considered treatment-related; no deaths in the placebo group were treatment-related.
INTERPRETATION
The primary endpoint was met with a significant improvement in independent review committee-assessed progression-free survival with venetoclax versus placebo plus bortezomib and dexamethasone. However, increased mortality was seen in the venetoclax group, mostly because of an increased rate of infections, highlighting the importance of appropriate selection of patients for this treatment option.
FUNDING
AbbVie and Genentech.",2020,"Serious treatment-emergent adverse events occurred in 93 (48%) patients in the venetoclax group and 48 (50%) patients in the placebo group, with eight (4%) treatment-emergent fatal infections reported in the venetoclax group and none reported in the placebo group.","['Between July 19, 2016, and Oct 31, 2017, 291 patients', 'patients aged 18 years or older with relapsed or refractory multiple myeloma, an Eastern Cooperative Oncology Group performance status of 2 or less, who had received one to three previous therapies were enrolled from 90 hospitals in 16 countries', 'Eligible patients', 'patients with relapsed or refractory multiple myeloma']","['placebo plus bortezomib and dexamethasone', 'venetoclax plus bortezomib and dexamethasone', 'interactive response technology system and a block size of three to receive venetoclax', 'bortezomib and dexamethasone', 'Venetoclax or placebo', 'placebo', 'Venetoclax plus bortezomib and dexamethasone', 'placebo with bortezomib (1·3 mg/m 2 subcutaneously or intravenously and dexamethasone', 'venetoclax']","['pneumonia', 'rate of infections', 'diarrhoea', 'thrombocytopenia', 'mortality', 'Serious treatment-emergent adverse events', 'neutropenia', 'median progression-free survival', 'review committee-assessed progression-free survival', 'anaemia', 'treatment-emergent fatal infections']","[{'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",291.0,0.759973,"Serious treatment-emergent adverse events occurred in 93 (48%) patients in the venetoclax group and 48 (50%) patients in the placebo group, with eight (4%) treatment-emergent fatal infections reported in the venetoclax group and none reported in the placebo group.","[{'ForeName': 'Shaji K', 'Initials': 'SK', 'LastName': 'Kumar', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA. Electronic address: kumar.shaji@mayo.edu.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Harrison', 'Affiliation': 'Clinical Hematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Seragnoli Institute of Hematology, Bologna University School of Medicine, Bologna, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'de la Rubia', 'Affiliation': 'Hematology Service, Dr Peset University Hospital, Valencia, Spain; School of Medicine and Dentistry, Catholic University of Valencia, Valencia, Spain.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Popat', 'Affiliation': 'Department of Haematology, University College London Hospitals, London, UK.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gasparetto', 'Affiliation': 'School of Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Hungria', 'Affiliation': 'Clinica São Germano, São Paulo, Brazil.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Salwender', 'Affiliation': 'Department of Hematology-Oncology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona and Asklepios Klinik St Georg, Hamburg, Germany.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.'}, {'ForeName': 'Inho', 'Initials': 'I', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Punnoose', 'Affiliation': 'Oncology Biomarker Development, Product Development, Hemtology, Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Wan-Jen', 'Initials': 'WJ', 'LastName': 'Hong', 'Affiliation': 'Oncology Biomarker Development, Product Development, Hemtology, Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Freise', 'Affiliation': 'Research and Development, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Research and Development, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Anjla', 'Initials': 'A', 'LastName': 'Sood', 'Affiliation': 'Research and Development, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Jalaluddin', 'Affiliation': 'Research and Development, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Ross', 'Affiliation': 'Research and Development, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Ward', 'Affiliation': 'Research and Development, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Paulo C', 'Initials': 'PC', 'LastName': 'Maciag', 'Affiliation': 'Research and Development, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital, Nantes, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30525-8']
1591,33129442,"Long-term follow-up from the ORATORIO trial of ocrelizumab for primary progressive multiple sclerosis: a post-hoc analysis from the ongoing open-label extension of the randomised, placebo-controlled, phase 3 trial.","BACKGROUND
The safety and efficacy of ocrelizumab in primary progressive multiple sclerosis were shown in the phase 3 ORATORIO trial. In this study, we assessed the effects of maintaining or switching to ocrelizumab therapy on measures of disease progression and safety in the open-label extension phase of ORATORIO.
METHODS
ORATORIO was an international, multicentre, double-blind, randomised, placebo-controlled, phase 3 trial done at 182 study locations including academic centres, hospitals, and community speciality centres within 29 countries across the Americas, Australia, Europe, Israel, New Zealand, and Russia. Patients with primary progressive multiple sclerosis aged 18-55 years who had an Expanded Disability Status Scale (EDSS) score of 3·0-6·5 were eligible for enrolment. Those who had previous treatment with B-cell-targeted therapies or other immunosuppressive medications were excluded. Eligible participants were randomly assigned (2:1) to receive either intravenous infusion of 600 mg of ocrelizumab (two 300 mg infusions 14 days apart) or placebo every 24 weeks for at least 120 weeks until a prespecified number (n=253) of disability events occurred. After the double-blind phase, patients entered an extended controlled period of variable duration, during which they and investigators became aware of treatment allocation. Following this period, patients could enter an optional open-label extension, during which they continued ocrelizumab or switched from placebo to ocrelizumab. Time to onset of disability progression was confirmed at 24 weeks with four measures (ie, increase in EDSS score, ≥20% increase in time to complete the 9-Hole Peg Test [9HPT], ≥20% increase in time to perform the Timed 25-Foot Walk [T25FW], and composite progression defined as the first confirmed occurrence of any of these three individual measures), as was time to requiring a wheelchair (EDSS ≥7). Conventional MRI measures were also analysed. The intention-to-treat population was used for the safety and efficacy analyses; all analyses, and their timings, were done post hoc. ORATORIO is registered with ClinicalTrials.gov, NCT01194570, and is ongoing.
FINDINGS
From March 3, 2011, to Dec 27, 2012, 488 patients were randomly assigned to the ocrelizumab group and 244 to the placebo group. The extended controlled period started on July 24, 2015, and ended on April 27, 2016, when the last patient entered the open-label extension. Overall, 544 (74%) of 732 participants completed the double-blind period to week 144; 527 (97%) of 544 entered the open-label extension phase, of whom 451 (86%) are ongoing in the open-label extension. After at least 6·5 study years (48 weeks per study year) of follow-up, the proportion of patients with progression on disability measures was lower in those who initiated ocrelizumab early than in those initially receiving placebo for most of the measures of 24-week confirmed disability progression: EDSS, 51·7% vs 64·8% (difference 13·1% [95% CI 4·9-21·3]; p=0·0018); 9HPT, 30·6% vs 43·1% (12·5% [4·1-20·9]); p=0·0035); T25FW, 63·2% vs 70·7% (7·5% [-0·3 to 15·2]; p=0·058); composite progression, 73·2% vs 83·3% (10·1% [3·6-16·6]; p=0·0023); and confirmed time to requiring a wheelchair, 11·5% vs 18·9% (7·4% [0·8-13·9]; p=0·0274). At study end, the percentage change from baseline was lower in those who initiated ocrelizumab early than in those initially receiving placebo for T2 lesion volume (0·45% vs 13·00%, p<0·0001) and T1 hypointense lesion volume (36·68% vs 60·93%, p<0·0001). Over the entire period, in the ORATORIO all ocrelizumab exposure population, the rate of adverse events was 238·09 (95% CI 232·71-243·57) per 100 patient-years and serious adverse events was 12·63 (95% CI 11·41-13·94) per 100 patient-years; the most common serious adverse events were infections at 4·13 (95% CI 3·45-4·91) per 100 patient-years. No new safety signals emerged compared with the double-blind phase of ORATORIO.
INTERPRETATION
Compared with patients switching from placebo, earlier and continuous ocrelizumab treatment provided sustained benefits on measures of disease progression over the 6·5 study years of follow-up. Although this study shows the benefit of earlier intervention with ocrelizumab in primary progressive disease, progression remains an important unmet need in multiple sclerosis. Further research should focus on how the potential benefits described in this study might be improved upon, particularly over longer time periods.
FUNDING
F Hoffmann-La Roche.",2020,"Compared with patients switching from placebo, earlier and continuous ocrelizumab treatment provided sustained benefits on measures of disease progression over the 6·5 study years of follow-up.","['732 participants completed the double-blind period to week 144; 527 (97%) of 544 entered the open-label extension phase, of whom 451 (86%) are ongoing in the open-label extension', '182 study locations including academic centres, hospitals, and community speciality centres within 29 countries across the Americas, Australia, Europe, Israel, New Zealand, and Russia', 'From March 3, 2011, to Dec 27, 2012, 488 patients', 'primary progressive multiple sclerosis', 'Eligible participants', 'Patients with primary progressive multiple sclerosis aged 18-55 years who had an Expanded Disability Status Scale (EDSS) score of 3·0-6·5 were eligible for enrolment', 'Those who had previous treatment with B-cell-targeted therapies or other immunosuppressive medications were excluded']","['intravenous infusion of 600 mg of ocrelizumab', 'ocrelizumab', 'maintaining or switching to ocrelizumab therapy', 'ocrelizumab or switched from placebo to ocrelizumab', 'placebo']","['proportion of patients with progression on disability measures', 'EDSS score', 'time to requiring a wheelchair (EDSS ≥7', 'disease progression', 'disease progression and safety', 'T1 hypointense lesion volume', 'time to perform the Timed 25-Foot Walk', 'rate of adverse events', 'Time to onset of disability progression', 'Conventional MRI measures', 'time to complete the 9-Hole Peg Test [9HPT', 'serious adverse events']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751964', 'cui_str': 'Primary progressive multiple sclerosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",488.0,0.35322,"Compared with patients switching from placebo, earlier and continuous ocrelizumab treatment provided sustained benefits on measures of disease progression over the 6·5 study years of follow-up.","[{'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Neurology, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, USA. Electronic address: jerry.s.wolinsky@uth.tmc.edu.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'Department of Neurology and Neurosurgery, Faculty of Medicine, McGill University, Montreal, QC, Canada; NeuroRx Research, Montreal, QC, Canada.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'Department of Neurology, University of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, Universitätsklinikum Düsseldorf, Center of Neurology and Neuropsychiatry, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""Neurology-Neuroimmunology Department and Neurorehabilitation Unit, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Naismith', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Manfrini', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Overell', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Koendgen', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Sauter', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Bennett', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Hubeaux', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hauser', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30342-2']
1592,33129754,Peer Support Added to Diabetes Education Improves Metabolic Control and Quality of Life in Mayan Adults Living With Type 2 Diabetes: A Randomized Controlled Trial.,"BACKGROUND
Yucatán, located in the southern region of Mexico, is the state with the country's highest prevalence of uncontrolled diabetes. Because of its particular cultural and socioeconomic characteristics, the residents of Yucatán face unique health-care challenges. The objective of our study was to evaluate the effect of peer support added to a diabetes education program on glycemic control and diabetes-related quality of life when compared with a conventional diabetes education program in patients with type 2 diabetes in a Mayan community in Mexico.
METHODS
In March 2015, a total of 58 participants with a previous diagnosis of type 2 diabetes who were recruited from community health centres in Komchén were randomly assigned in equal numbers to 1 of 2 groups: 1) a peer support and diabetes self-management education group (PSEG) or 2) a conventional diabetes self-management education-only group. The primary outcomes of interest were glycated hemoglobin (A1C) values and diabetes-related quality of life. The majority of subjects were bilingual (Mayan and Spanish speakers), female and middle aged, and had a low level of formal education and high baseline A1C (mean, 8.7%).
RESULTS
Whereas both groups showed significant improvements from baseline to study end in absolute levels of A1C, the PSEG group had a more pronounced clinical improvement, but no statistical improvement, in A1C compared with the conventional diabetes self-management education-only group. PSEG participants exhibited statistically significant improvement in diabetes-related quality of life at 8 months.
CONCLUSIONS
Our study demonstrates the benefits of peer-support education above and beyond the impact of diabetes self-management education on diabetes-related quality of life in an underserved Mayan community in Mexico.",2020,"Whereas both groups showed significant improvements from baseline to study end in absolute levels of A1C, the PSEG group had a more pronounced clinical improvement, but no statistical improvement, in A1C compared with the conventional diabetes self-management education-only group.","['patients with type 2 diabetes in a Mayan community in Mexico', '2 Diabetes', 'underserved Mayan community in Mexico', 'subjects were bilingual (Mayan and Spanish speakers), female and middle aged, and had a low level of formal education and high baseline A1C (mean, 8.7', '58 participants with a previous diagnosis of type 2 diabetes who were recruited from community health centres in Komchén', 'Mayan Adults Living With Type']","['peer support added to a diabetes education program', 'conventional diabetes education program', 'peer support and diabetes self-management education group (PSEG) or 2) a conventional diabetes self-management education-only group', 'Peer Support Added to Diabetes Education']","['diabetes-related quality of life', 'glycated hemoglobin (A1C) values and diabetes-related quality of life', 'Metabolic Control and Quality of Life', 'glycemic control and diabetes-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",58.0,0.0458887,"Whereas both groups showed significant improvements from baseline to study end in absolute levels of A1C, the PSEG group had a more pronounced clinical improvement, but no statistical improvement, in A1C compared with the conventional diabetes self-management education-only group.","[{'ForeName': 'Karen G', 'Initials': 'KG', 'LastName': 'Castillo-Hernandez', 'Affiliation': 'University of Mérida, Mérida, Mexico; Faculty of Medicine, Autonomous University of Yucatán, Mérida, Mexico.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Laviada-Molina', 'Affiliation': 'University of Mérida, Mérida, Mexico. Electronic address: hlaviada@marista.edu.mx.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Hernandez-Escalante', 'Affiliation': 'Faculty of Medicine, Autonomous University of Yucatán, Mérida, Mexico.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Molina-Segui', 'Affiliation': 'University of Mérida, Mérida, Mexico.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Mena-Macossay', 'Affiliation': 'University of Mérida, Mérida, Mexico.'}, {'ForeName': 'Augusto E', 'Initials': 'AE', 'LastName': 'Caballero', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, United States.'}]",Canadian journal of diabetes,['10.1016/j.jcjd.2020.08.107']
1593,33129819,Comparisons of Nonhyperemic Pressure Ratios: Predicting Functional Results of Coronary Revascularization Using Longitudinal Vessel Interrogation.,"OBJECTIVES
The aim of this study was to investigate the accuracy of pre-percutaneous coronary intervention (PCI) predicted nonhyperemic pressure ratios (NHPRs) with actual post-PCI NHPRs and to assess the efficacy of PCI strategy using pre-PCI NHPR pull back.
BACKGROUND
Predicting the functional results of PCI is feasible using pre-PCI longitudinal vessel interrogation with the instantaneous wave-free ratio (iFR), a pressure-based, adenosine-free NHPR. However, the reliability of novel NHPRs (resting full-cycle ratio [RFR] and diastolic pressure ratio [dPR]) for this purpose remains uncertain.
METHODS
In this prospective, multicenter, randomized controlled trial, vessels were randomly assigned to receive pre-PCI iFR, RFR, or dPR pull back (50 vessels each). The pre-PCI predicted NHPRs were compared with actual NHPRs after contemporary PCI using intravascular imaging. The number and the total length of treated lesions were compared between NHPR pull back-guided and angiography-guided strategies.
RESULTS
The predicted NHPRs were strongly correlated with actual NHPRs: iFR, r = 0.83 (95% confidence interval: 0.72 to 0.90; p < 0.001); RFR, r = 0.84 (95% confidence interval: 0.73 to 0.91; p < 0.001), and dPR, r = 0.84 (95% confidence interval: 0.73 to 0.91; p < 0.001). The number and the total length of treated lesions were lower with the NHPR pull back strategy than with the angiography-guided strategy, leading to physiological improvement.
CONCLUSIONS
Predicting functional PCI results on the basis of pre-procedural RFR and dPR pull backs yields similar results to iFR. Compared with an angiography-guided strategy, a pull back-guided PCI strategy with any of the 3 NHPRs reduced the number and the total length of treated lesions. (Study to Examine Correlation Between Predictive Value and Post PCI Value of iFR, RFR and dPR; UMIN000033534).",2020,"The number and the total length of treated lesions were lower with the NHPR pull back strategy than with the angiography-guided strategy, leading to physiological improvement.
",[],"['pre-PCI iFR, RFR, or dPR pull back', 'Coronary Revascularization Using Longitudinal Vessel Interrogation', 'pre-percutaneous coronary intervention (PCI']","['reliability of novel NHPRs (resting full-cycle ratio [RFR] and diastolic pressure ratio [dPR', 'number and the total length of treated lesions', 'nonhyperemic pressure ratios (NHPRs', 'Predictive Value and Post PCI Value of iFR, RFR and dPR']",[],"[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0406778', 'cui_str': 'Dermatopathia pigmentosa reticularis'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1442095', 'cui_str': 'Pressure ratio'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0406778', 'cui_str': 'Dermatopathia pigmentosa reticularis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.097615,"The number and the total length of treated lesions were lower with the NHPR pull back strategy than with the angiography-guided strategy, leading to physiological improvement.
","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Omori', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan. Electronic address: omori@heart-center.or.jp.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Kawase', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Mizukami', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan; Clinical Research Institute for Clinical Pharmacology and Therapeutics, Showa University, Tokyo, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Tanigaki', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Hirata', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Ota', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Sobue', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Taiji', 'Initials': 'T', 'LastName': 'Miyake', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Itta', 'Initials': 'I', 'LastName': 'Kawamura', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Munenori', 'Initials': 'M', 'LastName': 'Okubo', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Kamiya', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Hirakawa', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Yoriyasu', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Cardiovascular Medicine, Nagoya Heart Center, Nagoya, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Department of Cardiovascular Medicine, Nagoya Heart Center, Nagoya, Japan.'}, {'ForeName': 'Mitsuyasu', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Department of Cardiovascular Medicine, Toyohashi Heart Center, Toyohashi, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kondo', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Cardiovascular Medicine, Toyohashi Heart Center, Toyohashi, Japan.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clinico San Carlos IDISSC and Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Matsuo', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.06.060']
1594,33129910,Long-term toxicity and health-related quality of life after adjuvant chemoradiotherapy or radiotherapy alone for high-risk endometrial cancer in the randomised PORTEC-3 trial.,"BACKGROUND
The survival results of the PORTEC-3 trial showed a significant improvement in both overall and failure-free survival with chemoradiotherapy versus pelvic radiotherapy alone. The present analysis was performed to compare long-term adverse events (AE) and health-related quality of life (HRQOL).
PATIENTS AND METHODS
660 women with high-risk endometrial cancer were randomly assigned to receive chemoradiotherapy (2 concurrent cycles of cisplatin followed by 4 cycles of carboplatin/paclitaxel) or radiotherapy alone. Toxicity was graded using CTCAE v3.0. HRQOL was measured using EORTC QLQ-C30 and CX24/OV28-subscales and compared to normative-data. An as-treated analysis was performed.
RESULTS
Median follow up was 74.6 months; 574 (87%) patients were evaluable for HRQOL. At 5 years, grade ≥2 AE were scored for 78 (38%) patients who had received chemoradiotherapy versus 46 (24%) who had received radiotherapy (p=0.008). Grade 3 AE did not differ significantly between the groups (8% vs 5%, p=0.18) at 5 years, and only one new late grade 4 toxicity had been reported. At 3 and 5 years, sensory neuropathy toxicity grade ≥2 persisted after chemoradiotherapy in 6% (vs 0% after radiotherapy, p<0.001) and more patients reported significant tingling or numbness at HRQOL (27% vs 8%, p<0.001 at 3 years; 24% vs 9%, p=0.002 at 5 years). Until 3 years, more patients who had chemoradiotherapy reported limb weakness (21% vs 5%, p<0.001) and lower physical (79 vs 87, p<0.001) and role functioning (78 vs 88, p<0.001) scores. Both treatment groups reported similar long-term global health/QOL scores, which were better than those of the normative-population.
CONCLUSION
This study shows a long-lasting, clinically relevant, negative impact of chemoradiotherapy on toxicity and HRQOL, most importantly persistent peripheral sensory neuropathy. Physical and role functioning impairments were seen until 3 years. These long-term data are essential for patient information and shared decision-making regarding adjuvant chemotherapy for high-risk endometrial cancer.",2020,"Grade 3 AE did not differ significantly between the groups (8% vs 5%, p=0.18) at 5 years, and only one new late grade 4 toxicity had been reported.","['660 women with high-risk endometrial cancer', 'high-risk endometrial cancer']","['cisplatin followed by 4 cycles of carboplatin/paclitaxel) or radiotherapy alone', 'chemoradiotherapy versus pelvic radiotherapy alone', 'chemoradiotherapy', 'adjuvant chemoradiotherapy or radiotherapy alone', 'radiotherapy']","['similar long-term global health/QOL scores', 'sensory neuropathy toxicity grade ≥2', 'HRQOL', 'Toxicity', 'Physical and role functioning impairments', 'toxicity and HRQOL', 'Grade 3 AE', 'long-term adverse events (AE) and health-related quality of life (HRQOL', 'grade ≥2 AE', 'tingling or numbness at HRQOL', 'limb weakness', 'overall and failure-free survival']","[{'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C3178761', 'cui_str': 'Adjuvant Chemoradiotherapy'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0587246', 'cui_str': 'Muscle weakness of limb'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",660.0,0.321562,"Grade 3 AE did not differ significantly between the groups (8% vs 5%, p=0.18) at 5 years, and only one new late grade 4 toxicity had been reported.","[{'ForeName': 'Cathalijne C B', 'Initials': 'CCB', 'LastName': 'Post', 'Affiliation': 'Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: c.c.b.post@lumc.nl.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'de Boer', 'Affiliation': 'Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Melanie E', 'Initials': 'ME', 'LastName': 'Powell', 'Affiliation': 'Clinical Oncology, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mileshkin', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Dionyssios', 'Initials': 'D', 'LastName': 'Katsaros', 'Affiliation': 'Surgical Sciences and Gynecology, Città della Salute and S Anna Hospital, Torino, Italy.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bessette', 'Affiliation': 'Gynaecologic Oncology, University of Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Haie-Meder', 'Affiliation': 'Radiotherapy, Institus Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nelleke P B', 'Initials': 'NPB', 'LastName': 'Ottevanger', 'Affiliation': 'Medical Oncology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, London, United Kingdom.'}, {'ForeName': 'Pearly', 'Initials': 'P', 'LastName': 'Khaw', 'Affiliation': 'Radiation Oncology, Peter MacCallum Cancer Center, Melbourne, Australia.'}, {'ForeName': 'Romerai', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Radiotherapy, Azienda Socio Sanitaria Territoriale, Lecco, Italy.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Fyles', 'Affiliation': 'Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Canada.'}, {'ForeName': 'Marie Hélène', 'Initials': 'MH', 'LastName': 'Baron', 'Affiliation': 'Radiotherapy, Centre Hospitalier Régional Universitaire de Besançon, Besançon, France.'}, {'ForeName': 'Henry C', 'Initials': 'HC', 'LastName': 'Kitchener', 'Affiliation': 'Institute of Cancer Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Hans W', 'Initials': 'HW', 'LastName': 'Nijman', 'Affiliation': 'Gynecologic Oncology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Ludy C H W', 'Initials': 'LCHW', 'LastName': 'Lutgens', 'Affiliation': 'Radiation Oncology, MAASTRO, Maastricht, The Netherlands.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Brooks', 'Affiliation': 'Radiation Oncology, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Ina M', 'Initials': 'IM', 'LastName': 'Jürgenliemk-Schulz', 'Affiliation': 'Radiation Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Feeney', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, London, United Kingdom.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Goss', 'Affiliation': 'Medical Oncology, Box Hill Hospital, Melbourne, Australia.'}, {'ForeName': 'Roldano', 'Initials': 'R', 'LastName': 'Fossati', 'Affiliation': 'Medical Oncology, Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.'}, {'ForeName': 'Prafull', 'Initials': 'P', 'LastName': 'Ghatage', 'Affiliation': 'Gynecologic Oncology, Calgary-Tom Baker Cancer Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Leary', 'Affiliation': 'Cancer Medicine and Gynecological Tumor Translational Research Lab, Gustave Roussy Cancer Center - INSERM U981, Université Paris Saclay, Villejuif, France.'}, {'ForeName': 'Viet', 'Initials': 'V', 'LastName': 'Do', 'Affiliation': 'Radiation Oncology, Liverpool & Macarthur Cancer Therapy Centre, NSW, Australia.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Lissoni', 'Affiliation': 'Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McCormack', 'Affiliation': 'Clinical Oncology, University College London Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Remi A', 'Initials': 'RA', 'LastName': 'Nout', 'Affiliation': 'Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Karen W', 'Initials': 'KW', 'LastName': 'Verhoeven-Adema', 'Affiliation': 'Central Data Management and Trial Coordination, Comprehensive Cancer Center Netherlands, Rotterdam, The Netherlands.'}, {'ForeName': 'Vincent T H B M', 'Initials': 'VTHBM', 'LastName': 'Smit', 'Affiliation': 'Pathology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Carien L', 'Initials': 'CL', 'LastName': 'Creutzberg', 'Affiliation': 'Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.10.030']
1595,33129941,"A randomized, vehicle controlled clinical trial of a synthetic TRPM8 agonist (Cryosim-1) gel for itch.",,2020,,[],['synthetic TRPM8 agonist (Cryosim-1) gel'],[],[],"[{'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]",[],,0.153805,,"[{'ForeName': 'Min Je', 'Initials': 'MJ', 'LastName': 'Jung', 'Affiliation': 'Department of Dermatology, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Cheol', 'Initials': 'JC', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Edward Tak', 'Initials': 'ET', 'LastName': 'Wei', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA 94720, USA.'}, {'ForeName': 'Tudor', 'Initials': 'T', 'LastName': 'Selescu', 'Affiliation': 'Department of Anatomy, Physiology and Biophysics, Faculty of Biology, University of Bucharest, Bucuresti, Romania.'}, {'ForeName': 'Bo Young', 'Initials': 'BY', 'LastName': 'Chung', 'Affiliation': 'Department of Dermatology, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chun Wook', 'Initials': 'CW', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea. Electronic address: hyeonekim@gmail.com.'}, {'ForeName': 'Hye One', 'Initials': 'HO', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea. Electronic address: dermap@daum.net.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.10.065']
1596,33129962,"The efficacy of midline catheters - a prospective, randomised, active-controlled study.","OBJECTIVES
We investigated whether an IV strategy based on new generation midline catheters was an efficacious alternative to a conventional IV strategy consisting of peripheral venous catheters and central venous catheters, for patients needing IV therapy exceeding five days.
METHODS
This was a prospective, randomised, controlled study. Patients requiring more than five days IV treatment were randomised to either a midline catheter based IV strategy or a conventional strategy. The primary endpoint was composite of the insertion of a CVC or the need for ≥ four PVC insertions. The secondary outcomes included catheter dwell times and reasons for premature removal.
RESULTS
120 patients were included. In the midline group, the fraction of patients receiving ≥ four PVCs or had a CVC inserted was 12/58 (21%) vs. 38/58 (66%) in the conventional group (P < 0.001), number needed to treat: 2.2. Median overall catheter dwell times were 7 days (0-60 days) and 4 days (0-84 days) in the midline- and conventional groups, respectively (P = 0.002).
CONCLUSION
In patients requiring more than 5 days of IV therapy, a midline catheter strategy reduced the need for insertion of a CVC or more than 4 PVCs.
TRIAL REGISTRATION
ClinicalTrials (NCT03457259).",2020,"Median overall catheter dwell times were 7 days (0-60 days) and 4 days (0-84 days) in the midline- and conventional groups, respectively (P = 0.002).
","['Patients requiring more than five days IV treatment', '120 patients were included', 'patients needing IV therapy exceeding five days']","['midline catheters', 'midline catheter based IV strategy or a conventional strategy']","['Median overall catheter dwell times', 'catheter dwell times and reasons for premature removal', 'composite of the insertion of a CVC or the need for\u2009≥\u2009four PVC insertions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0032624', 'cui_str': 'Polyvinyl chloride'}]",120.0,0.166851,"Median overall catheter dwell times were 7 days (0-60 days) and 4 days (0-84 days) in the midline- and conventional groups, respectively (P = 0.002).
","[{'ForeName': 'Emma Bundgaard', 'Initials': 'EB', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anaesthesiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Antonsen', 'Affiliation': 'Department of Anaesthesiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Mensel', 'Affiliation': 'Department of Anaesthesiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Milandt', 'Affiliation': 'Department of Anaesthesiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Lars Skov', 'Initials': 'LS', 'LastName': 'Dalgaard', 'Affiliation': 'Department of Medicine, The Regional Hospital West Jutland, Gl. Landevej 72, 7400, Herning, Denmark.'}, {'ForeName': 'Britta Skov', 'Initials': 'BS', 'LastName': 'Illum', 'Affiliation': 'Department of Anaesthesiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Arildsen', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Juhl-Olsen', 'Affiliation': 'Department of Anaesthesiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark; Institute for Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 82, 8200, Aarhus N, Denmark. Electronic address: Peter.juhl-olsen@clin.au.dk.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.10.053']
1597,33136048,Masticatory efficiency of implant-supported mandibular overdentures retained with attachments compared with conventional dentures: an in vitro digital colorimetric image analysis.,"Despite the patient-reported advantages of implants in improving quality of life, satisfaction, and mastication, objective evaluations of the masticatory function and performance of implant-supported dentures are not well represented in the literature. The aim of the present study was to compare the masticatory efficiency of patients with conventional dentures with that of patients with mandibular overdentures retained by implants with 2 Locator attachments. A randomized clinical trial including 20 edentulous patients was conducted. The participants were randomly recruited into 2 groups, a group of 10 patients wearing conventional prostheses in both the maxilla and mandible, and a group of 10 patients wearing a conventional maxillary prosthesis opposite an implant-supported overdenture. To be included in the study, the patients had to have a well-formed ridge (Class I according to the Atwood classification). Their masticatory efficiency, assessed a minimum of 6 months after they received the denture, was evaluated through a color-mixing test using 2 colors of a commercially available chewing gum and ViewGum software, which calculated the variance of hue in the masticated specimens. The masticatory efficiency of the 2 groups was compared using repeated-measures analysis of variance (α = 0.05), which revealed no statistically significant difference between the implant-supported overdenture and conventional denture groups (P > 0.05). Within the limits of this study, the results suggest that a mandibular implant overdenture has no advantage over a conventional complete denture with regard to masticatory efficiency or food comminution in patients who have a well-formed mandibular ridge.",2020,"Their masticatory efficiency, assessed a minimum of 6 months after they received the denture, was evaluated through a color-mixing test using 2 colors of a commercially available chewing gum and ViewGum software, which calculated the variance of hue in the masticated specimens.","['20 edentulous patients', 'patients who have a well-formed mandibular ridge', 'patients had to have a well-formed ridge (Class I according to the Atwood classification', 'patients with conventional dentures with that of patients with mandibular overdentures retained by implants with 2 Locator attachments']","['implant-supported mandibular overdentures retained with attachments compared with conventional dentures', '10 patients wearing conventional prostheses in both the maxilla and mandible, and a group of 10 patients wearing a conventional maxillary prosthesis opposite an implant-supported overdenture']","['masticatory efficiency', 'Masticatory efficiency', 'quality of life, satisfaction, and mastication, objective evaluations of the masticatory function and performance of implant-supported dentures']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0457285', 'cui_str': 'Conventional denture'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0457285', 'cui_str': 'Conventional denture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0079806', 'cui_str': 'Maxillary Prosthesis'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0011394', 'cui_str': 'Denture'}]",20.0,0.0569504,"Their masticatory efficiency, assessed a minimum of 6 months after they received the denture, was evaluated through a color-mixing test using 2 colors of a commercially available chewing gum and ViewGum software, which calculated the variance of hue in the masticated specimens.","[{'ForeName': 'Zahraa A', 'Initials': 'ZA', 'LastName': 'Salami', 'Affiliation': ''}, {'ForeName': 'Elie M', 'Initials': 'EM', 'LastName': 'Jasser', 'Affiliation': ''}, {'ForeName': 'Joseph E D', 'Initials': 'JED', 'LastName': 'Makzoumé', 'Affiliation': ''}, {'ForeName': 'Paul J A', 'Initials': 'PJA', 'LastName': 'Boulos', 'Affiliation': ''}]",General dentistry,[]
1598,33136049,Efficacy of mental-incisive nerve block in root canal treatment of mandibular first molars with asymptomatic irreversible pulpitis: a randomized controlled trial.,"The aim of this study was to evaluate the effect of mental-incisive nerve block (MINB) along with finger pressure following inferior alveolar nerve block (IANB) on anesthetic success in mandibular first molars with asymptomatic irreversible pulpitis. In this randomized controlled trial, 70 patients were randomly divided into 2 groups (n = 35). Each patient in the control group received only a standard IANB injection of 1.8 mL of 2% lidocaine with 1:100,000 epinephrine. The injection was administered within 1 minute, using a standard aspirating dental cartridge fitted with a 27-gauge dental needle. In the intervention group, 15 minutes after injection of the standard IANB as described for the control group, each patient received a standard MINB injection of 1 mL of 2% lidocaine containing 1:100,000 epinephrine, administered by an operator not involved in assessing the outcomes. After the MINB injection, the patient applied firm finger pressure to the soft tissue of the mental foramen region for 1 minute using the hand on the side opposite to the injection. Objective assessment of tooth anesthesia was carried out with electric pulp tests (EPTs). In addition, the patients rated their pain during the initial steps of endodontic treatment based on a visual analog scale (VAS). The Mann-Whitney U and Wilcoxon tests were used for the analysis of data. Of the 35 patients in each group, 20.0% (7 patients) in the control group and 71.4% (25 patients) in the intervention group had no response to EPTs 15 minutes after injections; this difference was statistically significant (P < 0.05). The VAS pain scores were significantly higher in the control group than in the intervention group (P = 0.001). The administration of MINB with pressure following IANB significantly improved the success of anesthesia in mandibular first molars with asymptomatic irreversible pulpitis.",2020,The VAS pain scores were significantly higher in the control group than in the intervention group (P = 0.001).,"['70 patients were randomly divided into 2 groups (n = 35', 'mandibular first molars with asymptomatic irreversible pulpitis']","['standard MINB injection of 1 mL of 2% lidocaine containing 1:100,000 epinephrine', 'mental-incisive nerve block', 'finger pressure following inferior alveolar nerve block (IANB', 'standard IANB injection of 1.8 mL of 2% lidocaine with 1:100,000 epinephrine', 'mental-incisive nerve block (MINB', 'electric pulp tests (EPTs']","['visual analog scale (VAS', 'success of anesthesia', 'VAS pain scores', 'anesthetic success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}]",70.0,0.0700099,The VAS pain scores were significantly higher in the control group than in the intervention group (P = 0.001).,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Samiei', 'Affiliation': ''}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Yavari', 'Affiliation': ''}, {'ForeName': 'Shahriar', 'Initials': 'S', 'LastName': 'Shahi', 'Affiliation': ''}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Skandarinezhad', 'Affiliation': ''}, {'ForeName': 'Amir Ardalan', 'Initials': 'AA', 'LastName': 'Abdollahi', 'Affiliation': ''}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Abolhasani', 'Affiliation': ''}]",General dentistry,[]
1599,33136058,Injectable Amoxicillin Versus Injectable Ampicillin Plus Gentamicin in the Treatment of Severe Pneumonia in Children Aged 2 to 59 Months: Protocol for an Open-Label Randomized Controlled Trial.,"BACKGROUND
Pneumonia causes about 0.9 million deaths worldwide each year. The World Health Organization (WHO) guidelines for the standard management of severe pneumonia requires parenteral ampicillin every 6 hours and once-daily parenteral gentamicin for 5 to 7 days. Although this treatment has contributed to the reduction of mortality, it requires nursing interventions every 6 hours for 7 days. Further intervention trials should be conducted to search for alternate antibiotics with better adherence, reduced cost, and reduced hospital stay. Parenteral amoxicillin is an effective alternative to ampicillin, as it has a longer half-life and broader coverage.
OBJECTIVE
The aim of this clinical trial is to compare the efficacy of a dose of injectable amoxicillin every 12 hours plus a once-daily dose of injectable gentamicin with a dose of injectable ampicillin every 6 hours plus a once-daily dose of injectable gentamicin in children hospitalized for severe pneumonia.
METHODS
This randomized, controlled, open-label, noninferiority trial is being conducted in Dhaka Hospital of the International Centre for Diarrheal Disease Research, Bangladesh. A sample size of 308 children with severe pneumonia will give adequate power to this study. Children aged 2 to 59 months are randomized to either intravenous ampicillin or intravenous amoxicillin, plus intravenous gentamicin in both study arms. The monitoring of the patients is carried out according to the WHO protocol for the treatment of severe pneumonia. The primary objective is the rate of treatment failure, defined by the persistence of danger signs of severe pneumonia beyond 48 hours or deterioration within 24 hours of initiation of the therapy. The secondary objectives are (1) improvement in or the resolution of danger signs since enrollment, (2) length of hospital stay, (3) death during hospitalization, and (4) rate of nosocomial infections.
RESULTS
Enrollment in the study started on January 1, 2018, and ended on October 31, 2019. Data entry and analysis are in progress. Findings from the study are expected to be disseminated in October 2020.
CONCLUSIONS
Our study's findings will improve compliance with the use of antibiotics that require less frequent doses for the treatment of severe pneumonia.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03369093; https://clinicaltrials.gov/ct2/show/NCT03369093.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/17735.",2020,"The primary objective is the rate of treatment failure, defined by the persistence of danger signs of severe pneumonia beyond 48 hours or deterioration within 24 hours of initiation of the therapy.","['308 children with severe pneumonia', 'children hospitalized for severe pneumonia', 'Severe Pneumonia in Children', 'Children aged 2 to 59 months', 'Enrollment in the study started on January 1, 2018, and ended on October 31, 2019']","['Injectable Amoxicillin Versus Injectable Ampicillin Plus Gentamicin', 'intravenous ampicillin or intravenous amoxicillin, plus intravenous gentamicin', 'injectable gentamicin', 'Parenteral amoxicillin', 'injectable amoxicillin', 'gentamicin']","['resolution of danger signs since enrollment, (2) length of hospital stay, (3) death during hospitalization, and (4) rate of nosocomial infections', 'rate of treatment failure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0002680', 'cui_str': 'Ampicillin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]","[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010356', 'cui_str': 'Cross infection'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}]",308.0,0.16116,"The primary objective is the rate of treatment failure, defined by the persistence of danger signs of severe pneumonia beyond 48 hours or deterioration within 24 hours of initiation of the therapy.","[{'ForeName': 'Lubaba', 'Initials': 'L', 'LastName': 'Shahrin', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammod Jobayer', 'Initials': 'MJ', 'LastName': 'Chisti', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Abu Sadat Mohammad Sayeem Bin', 'Initials': 'ASMSB', 'LastName': 'Shahid', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Abu Sayem Mirza Mohammad Hasibur', 'Initials': 'ASMMH', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Md Zahidul', 'Initials': 'MZ', 'LastName': 'Islam', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Afroze', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Sayeeda', 'Initials': 'S', 'LastName': 'Huq', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}]",JMIR research protocols,['10.2196/17735']
1600,33136059,Effectiveness of Internet-Based Multicomponent Interventions for Patients and Health Care Professionals to Improve Clinical Outcomes in Type 2 Diabetes Evaluated Through the INDICA Study: Multiarm Cluster Randomized Controlled Trial.,"BACKGROUND
Type 2 diabetes mellitus (T2DM) is a chronic disease in which health outcomes are related to decision making by patients and health care professionals.
OBJECTIVE
This study aims to assess the effectiveness of internet-based multicomponent interventions to support decision making of all actors involved in the care of patients with T2DM in primary care.
METHODS
The INDICA study is an open, community-based, multicenter trial with random allocation to usual care or the intervention for patients, the intervention for health care professionals in primary care, or the combined intervention for both. In the intervention for patients, participants received an educational group program and were monitored and supported by logs, a web-based platform, and automated SMS. Those in the intervention for professionals also received an educational program, a decision support tool embedded in the electronic clinical record, and periodic feedback about patients' results. A total of 2334 people with T2DM, regardless of glycated hemoglobin (HbA 1c ) levels and without diabetes-related complications, were included. The primary end point was change in HbA 1c level. The main analysis was performed using multilevel mixed models.
RESULTS
For the overall sample, the intervention for patients attained a significant mean reduction in HbA 1c levels of ‒0.27 (95% CI ‒0.45 to ‒0.10) at month 3 and ‒0.26 (95% CI ‒0.44 to ‒0.08) at month 6 compared with usual care, which remained marginally significant at month 12. A clinically relevant reduction in HbA 1c level was observed in 35.6% (191/537) of patients in the intervention for patients and 26.0% (152/586) of those in usual care at month 12 (P=.006). In the combined intervention, HbA 1c reduction was significant until month 18 (181/557, 32.6% vs 140/586, 23.9%; P=.009). Considering the subgroup of patients uncontrolled at baseline, all interventions produced significant reductions in HbA 1c levels across the entire study period: ‒0.49 (95% CI ‒0.70 to ‒0.27) for the intervention for patients, ‒0.35 (95% CI ‒0.59 to ‒0.14) for the intervention for professionals, and ‒0.35 (95% CI ‒0.57 to ‒0.13) for the combined intervention. Differences in HbA 1c for the area under the curve considering the entire period were significant for the intervention for patients and the combined intervention compared with usual care (P=.03 for both). Compared with usual care, the intervention for professionals and the combined intervention had significant longer-term reductions in systolic and diastolic blood pressure.
CONCLUSIONS
In uncontrolled patients, the intervention for patients at baseline provided clinically relevant and significant longer-term reductions of HbA 1c levels. The intervention for professionals and combined intervention also improved the cardiovascular risk profile of patients.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01657227; https://clinicaltrials.gov/ct2/show/NCT01657227.",2020,"Compared with usual care, the intervention for professionals and the combined intervention had significant longer-term reductions in systolic and diastolic blood pressure.
","['patients with T2DM in primary care', 'Type 2 Diabetes', '2334 people with T2DM, regardless of glycated hemoglobin (HbA 1c ) levels and without diabetes-related complications, were included', 'Patients and Health Care Professionals']","['Internet-Based Multicomponent Interventions', 'internet-based multicomponent interventions']","['systolic and diastolic blood pressure', 'cardiovascular risk profile', 'change in HbA 1c level', 'HbA 1c level', 'HbA 1c levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0342257', 'cui_str': 'Diabetic complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",2334.0,0.112916,"Compared with usual care, the intervention for professionals and the combined intervention had significant longer-term reductions in systolic and diastolic blood pressure.
","[{'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Ramallo-Fariña', 'Affiliation': 'Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'García-Bello', 'Affiliation': 'Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'García-Pérez', 'Affiliation': 'Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Boronat', 'Affiliation': 'Department of Endocrinology and Nutrition, Insular University Hospital, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Wägner', 'Affiliation': 'Department of Endocrinology and Nutrition, Insular University Hospital, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Rodríguez-Rodríguez', 'Affiliation': 'Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'de Pablos-Velasco', 'Affiliation': 'University Institute for Biomedical and Health Research (IUIBS), University of Las Palmas de Gran Canaria (ULPG), Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Llorente Gómez de Segura', 'Affiliation': 'Department of Endocrinology and Nutrition, Nuestra Señora de la Candelaria University Hospital, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Himar', 'Initials': 'H', 'LastName': 'González-Pacheco', 'Affiliation': 'Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Carmona Rodríguez', 'Affiliation': 'Research Network on Health Services in Chronic Diseases (REDISSEC), Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Serrano-Aguilar', 'Affiliation': 'Research Network on Health Services in Chronic Diseases (REDISSEC), Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'See Author´s Contributions Section, Santa Cruz de Tenerife, Spain.'}]",JMIR mHealth and uHealth,['10.2196/18922']
1601,33136078,Efficacy of task-specific circuit training on physical activity levels and mobility of stroke patients: A randomized controlled trial.,"BACKGROUND
Impaired mobility is related to low physical activity (PA) levels observed after stroke. Therapeutic approaches, such as task-specific circuit training (TSCT), used to improve mobility in individuals with stroke, could also improve PA levels.
OBJECTIVE
To investigate the efficacy of TSCT, focused on both upper (UL) and lower (LL) limbs, in improving PA levels and mobility (primary outcomes), as well as muscle strength, exercise capacity, and quality of life (secondary outcomes) in subjects with stroke.
METHODS
A randomized controlled trial with 36 subjects with chronic stroke was conducted. Experimental group: TSCT, involving both UL and LL.
CONTROL GROUP
global stretching, memory exercises, and education sessions. Both groups received 60 minute sessions/week over 12 weeks. Outcomes were measured at baseline, post-intervention and 16 week follow-up.
RESULTS
No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02).
CONCLUSION
TSCT focused on both UL and LL was not effective on PA levels and mobility of individuals with chronic stroke, however, improvements in quality of life were observed. Since this is the first study to investigate this combined training aimed at improving PA levels, future studies are necessary to better understand the impact of this type of intervention.",2020,"No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02).
","['stroke patients', 'individuals with stroke', 'subjects with stroke', '36 subjects with chronic stroke']","['task-specific circuit training (TSCT', 'task-specific circuit training', 'TSCT']","['muscle strength, exercise capacity, and quality of life', 'low physical activity (PA) levels', 'quality of life', 'PA levels and mobility of individuals with chronic stroke']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]",36.0,0.0455424,"No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02).
","[{'ForeName': 'Júlia Caetano', 'Initials': 'JC', 'LastName': 'Martins', 'Affiliation': 'Universidade Federal de Minas Gerais (UFMG), Department of Physical Therapy, Belo Horizonte, Brazil.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Nadeau', 'Affiliation': ""Université de Montreal (UdeM), Centre de recherche interdisciplinaire en réadaptation (CRIR), Institut de réadaptation Gingras-Lindsay de Montréal (IRGLM), CIUSSS Centre-Sud-de-l'île-de-Montréal, Montréal, Canada.""}, {'ForeName': 'Larissa Tavares', 'Initials': 'LT', 'LastName': 'Aguiar', 'Affiliation': 'Universidade Federal de Minas Gerais (UFMG), Department of Physical Therapy, Belo Horizonte, Brazil.'}, {'ForeName': 'Aline Alvim', 'Initials': 'AA', 'LastName': 'Scianni', 'Affiliation': 'Universidade Federal de Minas Gerais (UFMG), Department of Physical Therapy, Belo Horizonte, Brazil.'}, {'ForeName': 'Luci Fuscaldi', 'Initials': 'LF', 'LastName': 'Teixeira-Salmela', 'Affiliation': 'Universidade Federal de Minas Gerais (UFMG), Department of Physical Therapy, Belo Horizonte, Brazil.'}, {'ForeName': 'Christina Danielli Coelho', 'Initials': 'CDC', 'LastName': 'De Morais Faria', 'Affiliation': 'Universidade Federal de Minas Gerais (UFMG), Department of Physical Therapy, Belo Horizonte, Brazil.'}]",NeuroRehabilitation,['10.3233/NRE-203207']
1602,33136089,Effects of elastic tape in pregnant women with low back pain: A randomized controlled trial.,"BACKGROUND
Low back pain is a common problem in pregnant woman. Elastic tape is an alternative method that may reduce low back pain.
OBJECTIVES
To compare the effect of elastic tape to placebo tape in the treatment of low back pain in pregnant women.
METHODS
Forty pregnant women were allocated into two groups: elastic group (n= 20) and placebo group (n= 20). All participants were taped by either stretched (elastic group) or non-stretched (placebo group) Kinesio tape at the lower back area for one week.
RESULTS
After the application of stretched elastic tape, lower back pain was significantly reduced by 29.4% (p= 0.003) immediately post-taping and by a further 75.4% after wearing the tape for a week. Compared to the placebo group, lower back pain was significantly reduced in the elastic group after one week of wearing the tape (p< 0.001). Compared to placebo, the application of elastic tape significantly reduced the disability score (Roland-Morris Disability Questionnaire) after one week of wearing the tape (p= 0.018). Taping to the back improved walking speed (immediately and after one week) in both the elastic (p< 0.001, p< 0.001) and placebo groups (p< 0.001, p= 0.001); however, the application of either tape had little effect on posture change.
CONCLUSION
Elastic tape reduced back pain and improved physical function in pregnant women compared to the placebo tape.",2020,"Compared to the placebo group, lower back pain was significantly reduced in the elastic group after one week of wearing the tape (p< 0.001).","['Forty pregnant women', 'pregnant women', 'pregnant women with low back pain', 'pregnant woman']","['elastic tape', 'Kinesio tape', 'stretched (elastic group) or non-stretched (placebo group', 'placebo', 'Elastic tape', 'elastic tape to placebo tape']","['low back pain', 'disability score (Roland-Morris Disability Questionnaire', 'lower back pain', 'back pain', 'posture change', 'walking speed', 'physical function']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",40.0,0.2659,"Compared to the placebo group, lower back pain was significantly reduced in the elastic group after one week of wearing the tape (p< 0.001).","[{'ForeName': 'Matchimamart', 'Initials': 'M', 'LastName': 'Chamnankrom', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Nuttaset', 'Initials': 'N', 'LastName': 'Manimmanakorn', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Apiwan', 'Initials': 'A', 'LastName': 'Manimmanakorn', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kiattisak', 'Initials': 'K', 'LastName': 'Kongwattanakul', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hamlin', 'Affiliation': 'Department of Tourism, Sport and Society, Lincoln University, Christchurch, New Zealand.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200094']
1603,33136119,Lifestyle Intervention With or Without Lay Volunteers to Prevent Type 2 Diabetes in People With Impaired Fasting Glucose and/or Nondiabetic Hyperglycemia: A Randomized Clinical Trial.,"Importance
Nearly half of the older adult population has diabetes or a high-risk intermediate glycemic category, but we still lack trial evidence for effective type 2 diabetes prevention interventions in most of the current high-risk glycemic categories.
Objective
To determine whether a group-based lifestyle intervention (with or without trained volunteers with type 2 diabetes) reduced the risk of progression to type 2 diabetes in populations with a high-risk glycemic category.
Design, Setting, and Participants
The Norfolk Diabetes Prevention Study was a parallel, 3-arm, group-based, randomized clinical trial conducted with up to 46 months of follow-up from August 2011 to January 2019 at 135 primary care practices and 8 intervention sites in the East of England. We identified 141 973 people at increased risk of type 2 diabetes, screened 12 778 (9.0%), and randomized those with a high-risk glycemic category, which was either an elevated fasting plasma glucose level alone (≥110 and <126 mg/dL [to convert to millimoles per liter, multiply by 0.0555]) or an elevated glycated hemoglobin level (≥6.0% to <6.5%; nondiabetic hyperglycemia) with an elevated fasting plasma glucose level (≥100 to <110 mg/dL).
Interventions
A control arm receiving usual care (CON), a theory-based lifestyle intervention arm of 6 core and up to 15 maintenance sessions (INT), or the same intervention with support from diabetes prevention mentors, trained volunteers with type 2 diabetes (INT-DPM).
Main Outcomes and Measures
Type 2 diabetes incidence between arms.
Results
In this study, 1028 participants were randomized (INT, 424 [41.2%] [166 women (39.2%)]; INT-DPM, 426 [41.4%] [147 women (34.5%)]; CON, 178 [17.3%] [70 women (%39.3)]) between January 1, 2011, and February 24, 2017. The mean (SD) age was 65.3 (10.0) years, mean (SD) body mass index 31.2 (5) (calculated as weight in kilograms divided by height in meters squared), and mean (SD) follow-up 24.7 (13.4) months. A total of 156 participants progressed to type 2 diabetes, which comprised 39 of 171 receiving CON (22.8%), 55 of 403 receiving INT (13.7%), and 62 of 414 receiving INT-DPM (15.0%). There was no significant difference between the intervention arms in the primary outcome (odds ratio [OR], 1.14; 95% CI, 0.77-1.7; P = .51), but each intervention arm had significantly lower odds of type 2 diabetes (INT: OR, 0.54; 95% CI, 0.34-0.85; P = .01; INT-DPM: OR, 0.61; 95% CI, 0.39-0.96; P = .033; combined: OR, 0.57; 95% CI, 0.38-0.87; P = .01). The effect size was similar in all glycemic, age, and social deprivation groups, and intervention costs per participant were low at $153 (£122).
Conclusions and Relevance
The Norfolk Diabetes Prevention lifestyle intervention reduced the risk of type 2 diabetes in current high-risk glycemic categories. Enhancing the intervention with DPM did not further reduce diabetes risk. These translatable results are relevant for current diabetes prevention efforts.
Trial Registration
ISRCTN Registry Identifier: ISRCTN34805606.",2020,"The effect size was similar in all glycemic, age, and social deprivation groups, and intervention costs per participant were low at $153 (£122).
","['to type 2 diabetes in populations with a high-risk glycemic category', 'People With Impaired Fasting Glucose and/or Nondiabetic Hyperglycemia', 'The mean (SD) age was 65.3 (10.0) years, mean (SD) body mass index 31.2 (5) (calculated as weight in kilograms divided by height in meters squared), and mean (SD) follow-up 24.7 (13.4) months', '1028 participants were randomized (INT, 424 [41.2%] [166 women (39.2', 'up to 46 months of follow-up from August 2011 to January 2019 at 135 primary care practices and 8 intervention sites in the East of England', '156 participants progressed to type 2 diabetes, which comprised 39 of 171 receiving CON (22.8%), 55 of 403 receiving INT (13.7%), and 62 of 414 receiving INT-DPM (15.0', '141\u202f973 people at increased risk of type 2 diabetes, screened 12\u202f778 (9.0%), and randomized those with a high-risk glycemic category, which was either an elevated fasting plasma glucose level alone (≥110 and <126 mg/dL [to convert to millimoles per liter, multiply by 0.0555]) or an elevated glycated hemoglobin level (≥6.0% to <6.5%; nondiabetic hyperglycemia) with an elevated fasting plasma glucose level (≥100 to <110 mg/dL']","['Lifestyle Intervention With or Without Lay Volunteers', 'Norfolk Diabetes Prevention lifestyle intervention', 'control arm receiving usual care (CON), a theory-based lifestyle intervention arm of 6 core and up to 15 maintenance sessions (INT), or the same intervention with support from diabetes prevention mentors, trained volunteers with type 2 diabetes (INT-DPM', 'group-based lifestyle intervention (with or without trained volunteers with type 2 diabetes']","['diabetes risk', 'risk of progression', 'Main Outcomes and Measures\n\n\nType 2 diabetes incidence between arms']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C5191319', 'cui_str': '31.2'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C1634619', 'cui_str': 'dpm'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C1719797', 'cui_str': 'Multiply'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0454866', 'cui_str': 'Norfolk'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1634619', 'cui_str': 'dpm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]",1028.0,0.0549156,"The effect size was similar in all glycemic, age, and social deprivation groups, and intervention costs per participant were low at $153 (£122).
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sampson', 'Affiliation': 'Elsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital National Health Service Trust, Norwich, England.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, England.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bachmann', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, England.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Garner', 'Affiliation': 'Elsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital National Health Service Trust, Norwich, England.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Irvine', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, England.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Howe', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, England.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Greaves', 'Affiliation': 'School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham, Birmingham, England.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Auckland', 'Affiliation': 'Elsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital National Health Service Trust, Norwich, England.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, England.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Elsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital National Health Service Trust, Norwich, England.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Rea', 'Affiliation': 'Elsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital National Health Service Trust, Norwich, England.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Rayman', 'Affiliation': 'Department of Diabetes and Endocrinology, Ipswich General Hospital, Ipswich, England.'}, {'ForeName': 'Ketan', 'Initials': 'K', 'LastName': 'Dhatariya', 'Affiliation': 'Elsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital National Health Service Trust, Norwich, England.'}, {'ForeName': 'W Garry', 'Initials': 'WG', 'LastName': 'John', 'Affiliation': 'Department Clinical Biochemistry, Norfolk and Norwich University Hospital NHS Trust, Norwich, England.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Barton', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, England.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Usher', 'Affiliation': 'Elsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital National Health Service Trust, Norwich, England.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Ferns', 'Affiliation': 'Elsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital National Health Service Trust, Norwich, England.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Pascale', 'Affiliation': 'Elsie Bertram Diabetes Centre, Department of Diabetes and Endocrinology, Norfolk and Norwich University Hospital National Health Service Trust, Norwich, England.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2020.5938']
1604,33136134,The Efficacy and Safety of Vitamin C for Iron Supplementation in Adult Patients With Iron Deficiency Anemia: A Randomized Clinical Trial.,"Importance
It remains uncertain whether vitamin C routinely used with oral iron supplements is essential for patients with iron deficiency anemia (IDA).
Objective
To compare the equivalence and assess the safety of oral iron supplements plus vitamin C or oral iron supplements alone in patients with IDA.
Design, Setting, and Participants
This single-center, open-label, equivalence randomized clinical trial was conducted from January 1, 2016, to December 30, 2017, in Huashan Hospital, Fudan University. Adult patients with newly diagnosed IDA were enrolled. Participants were randomly assigned (1:1) to the oral iron supplements plus vitamin C group or the oral iron supplements-only group. Data analysis was performed from March to December 2018.
Interventions
Patients were randomized to receive a 100-mg oral iron tablet plus 200 mg of vitamin C or a 100-mg iron tablet alone every 8 hours daily for 3 months.
Main Outcomes and Measures
The primary outcome was the change in hemoglobin level from baseline to 2 weeks of treatment, and an equivalence margin of 1 g/dL in hemoglobin was chosen for the demonstration of comparable efficacy. Secondary outcomes included the change in the reticulocyte percentage after 2 weeks of treatment, the increase in hemoglobin level after 4 weeks of treatment, the increase in serum ferritin level after 8 weeks of treatment, and adverse events.
Results
Among the 440 randomized patients (220 each in the oral iron supplements plus vitamin C group and iron-only group; 426 women [96.8%]; mean [SD] age, 38.3 [11.7] years), all were assessed for the primary outcome, and 432 (98.2%) completed the trial. From baseline to the 2-week follow-up, the mean (SD) change in hemoglobin level was 2.00 (1.08) g/dL in the oral iron supplements plus vitamin C group and 1.84 (0.97) g/dL in the oral iron supplements-only group (between-group difference, 0.16 g/dL; 95% CI, -0.03 to 0.35 g/dL), thus meeting the criteria for equivalence. The mean (SD) change in serum ferritin level from baseline to 8-week follow-up was 35.75 (11.52) ng/mL in the vitamin C plus iron group and 34.48 (9.50) ng/mL in the iron-only group (between-group difference, 1.27 ng/mL; 95% CI, -0.70 to 3.24 ng/mL; P = .21). There were no significant differences between the 2 groups regarding the rates of adverse events (46 [20.9%] vs 45 [20.5%]; difference, 0.4%; 95% CI, -6.7% to 8.5%; P = .82). No patient withdrew because of adverse events.
Conclusions and Relevance
Among patients with IDA, oral iron supplements alone were equivalent to oral iron supplements plus vitamin C in improving hemoglobin recovery and iron absorption. These findings suggest that on-demand vitamin C supplements are not essential to take along with oral iron supplements for patients with IDA.
Trial Registration
ClinicalTrials.gov Identifier: NCT02631668.",2020,"There were no significant differences between the 2 groups regarding the rates of adverse events (46 [20.9%] vs 45 [20.5%]; difference, 0.4%; 95% CI, -6.7% to 8.5%; P = .82).","['Adult patients with newly diagnosed IDA were enrolled', '440 randomized patients (220 each in the', 'January 1, 2016, to December 30, 2017, in Huashan Hospital, Fudan University', 'Adult Patients', 'patients with IDA', 'With Iron Deficiency Anemia', 'patients with iron deficiency anemia (IDA', 'group and iron-only group; 426 women [96.8%]; mean [SD] age, 38.3 [11.7] years), all were assessed for the primary outcome, and 432 (98.2%) completed the trial']","['Vitamin C', 'oral iron supplements plus vitamin C or oral iron supplements alone', 'vitamin C supplements', 'oral iron supplements plus vitamin C group or the oral iron supplements-only group', 'oral iron supplements plus vitamin C', '100-mg oral iron tablet plus 200 mg of vitamin C', 'vitamin C']","['hemoglobin level', 'mean (SD) change in hemoglobin level', 'adverse events', 'hemoglobin recovery and iron absorption', 'mean (SD) change in serum ferritin level', 'rates of adverse events', 'change in hemoglobin level', 'serum ferritin level', 'change in the reticulocyte percentage']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517535', 'cui_str': '11.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0721124', 'cui_str': 'Iron supplement'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3661608', 'cui_str': 'Vitamin C supplement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1167975', 'cui_str': 'Reticulocyte percentage'}]",440.0,0.544365,"There were no significant differences between the 2 groups regarding the rates of adverse events (46 [20.9%] vs 45 [20.5%]; difference, 0.4%; 95% CI, -6.7% to 8.5%; P = .82).","[{'ForeName': 'Nianyi', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Guangjie', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Hematology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Wanling', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Mengxue', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Hematology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Weiyang', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Qinfen', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Huashan Hospital, Fudan University, Shanghai, China.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.23644']
1605,33136142,Enhancing Motor Brain Activity Improves Memory for Action Language: A tDCS Study.,"The embodied cognition approach to linguistic meaning posits that action language understanding is grounded in sensory-motor systems. However, evidence that the human motor cortex is necessary for action language memory is meager. To address this issue, in two groups of healthy individuals, we perturbed the left primary motor cortex (M1) by means of either anodal or cathodal transcranial direct current stimulation (tDCS), before participants had to memorize lists of manual action and attentional sentences. In each group, participants received sham and active tDCS in two separate sessions. Following anodal tDCS (a-tDCS), participants improved the recall of action sentences compared with sham tDCS. No similar effects were detected following cathodal tDCS (c-tDCS). Both a-tDCS and c-tDCS induced variable changes in motor excitability, as measured by motor-evoked potentials induced by transcranial magnetic stimulation. Remarkably, across groups, action-specific memory improvements were positively predicted by changes in motor excitability. We provide evidence that excitatory modulation of the motor cortex selectively improves performance in a task requiring comprehension and memory of action sentences. These findings indicate that M1 is necessary for accurate processing of linguistic meanings and thus provide causal evidence that high-order cognitive functions are grounded in the human motor system.",2020,"Following anodal tDCS (a-tDCS), participants improved the recall of action sentences compared with sham tDCS.","['Action Language', 'two groups of healthy individuals, we perturbed the left primary motor cortex (M1) by means of either']","['sham and active tDCS', 'anodal tDCS (a-tDCS', 'anodal or cathodal transcranial direct current stimulation (tDCS), before participants had to memorize lists of manual action and attentional sentences']","['motor excitability', 'recall of action sentences', 'action-specific memory improvements']","[{'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0441472', 'cui_str': 'Action'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.0394181,"Following anodal tDCS (a-tDCS), participants improved the recall of action sentences compared with sham tDCS.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Vitale', 'Affiliation': 'Instituto Universitario de Neurociencia, Universidad de La Laguna, Santa Cruz de Tenerife 38200, Spain.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Padrón', 'Affiliation': 'Instituto Universitario de Neurociencia, Universidad de La Laguna, Santa Cruz de Tenerife 38200, Spain.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Avenanti', 'Affiliation': 'Dipartimento di Psicologia, Centro studi e ricerche in Neuroscienze Cognitive, Alma Mater Studiorum-Università di Bologna, Cesena 47521, Italy.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'de Vega', 'Affiliation': 'Instituto Universitario de Neurociencia, Universidad de La Laguna, Santa Cruz de Tenerife 38200, Spain.'}]","Cerebral cortex (New York, N.Y. : 1991)",['10.1093/cercor/bhaa309']
1606,33136703,"Changes in Appetite During the Heart Failure Trajectory and Association With Fatigue, Depressive Symptoms, and Quality of Life.","BACKGROUND
Decreased appetite can contribute to malnutrition in patients with heart failure (HF). Little is known about the trajectory of appetite over time in patients with HF and the factors associated with decreased appetite after discharge from the hospital.
OBJECTIVE
The aims of this study were to investigate changes in appetite over time and explore how fatigue, depressive symptoms, and quality of life are associated with decreased appetite.
METHODS
Data from the multicenter randomized Coordinating study evaluating Outcomes of Advising and Counseling in Heart Failure were used. Logistic regression and mixed-effects logistic regression were used to investigate changes in appetite over time and to explore the relationship between appetite and fatigue, depressive symptoms, and quality of life.
RESULTS
A total of 734 patients with HF (mean age, 69 years) were included. Decreased appetite was present at all follow-up measurements; however, decreased appetite was significantly lower at the 1-month (odds ratio [OR], 0.43; confidence interval [CI], 0.29-0.63), 6-month (OR, 0.31; CI, 0.20-0.47), 12-month (OR, 0.22; CI, 0.14-0.34), and 18-month (OR, 0.24; CI, 0.15-0.37) follow-ups compared with baseline. Decreased appetite was associated with fatigue (OR, 3.09; CI, 1.98-4.84), depressive symptoms (OR, 1.76; CI, 1.35-2.29), and low quality of life (OR, 1.01; CI, 1.01-1.02) across all measurement points adjusted for covariates.
CONCLUSIONS
Appetite improved after discharge; however, at all time points, at least 22% of patients reported decreased appetite. Fatigue, depressive symptoms, and low quality of life are factors associated with decreased appetite. Decreased appetite is a long-standing problem in that it does not disappear spontaneously after an acute HF deterioration.",2020,"Decreased appetite was associated with fatigue (OR, 3.09; CI, 1.98-4.84), depressive symptoms (OR, 1.76; CI, 1.35-2.29), and low quality of life (OR, 1.01; CI, 1.01-1.02) across all measurement points adjusted for covariates.
","['patients with heart failure (HF', '734 patients with HF (mean age, 69 years) were included']",[],"['appetite over time and explore how fatigue, depressive symptoms, and quality of life', 'Fatigue, Depressive Symptoms, and Quality of Life', 'low quality of life', 'Fatigue, depressive symptoms, and low quality of life', 'appetite', 'appetite and fatigue, depressive symptoms, and quality of life', 'depressive symptoms', 'decreased appetite', 'Decreased appetite']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}]",734.0,0.0661904,"Decreased appetite was associated with fatigue (OR, 3.09; CI, 1.98-4.84), depressive symptoms (OR, 1.76; CI, 1.35-2.29), and low quality of life (OR, 1.01; CI, 1.01-1.02) across all measurement points adjusted for covariates.
","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Andreae', 'Affiliation': 'Christina Andreae, PhD, RN Postdoctoral Researcher, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden, and Centre for Clinical Research Sörmland, Uppsala University, Eskilstuna, Sweden. Martje H.L. van der Wal, PhD, RN Senior Researcher, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden, and Heart Failure Nurse, Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands. Dirk J. van Veldhuisen, PhD, MD Professor, Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands. Bei Yang, Msc Statistician, Centre for Clinical Research Sörmland, Uppsala University, Eskilstuna, Sweden. Anna Strömberg, PhD, RN Professor, Department of Health, Medicine and Caring Sciences and Department of Cardiology, Linköping University, Linköping, Sweden. Tiny Jaarsma, PhD, RN Professor, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden, and Professor, Julius Center, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Martje H L', 'Initials': 'MHL', 'LastName': 'van der Wal', 'Affiliation': ''}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': ''}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Strömberg', 'Affiliation': ''}, {'ForeName': 'Tiny', 'Initials': 'T', 'LastName': 'Jaarsma', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000756']
1607,33136751,Long-Acting Injectable Cabotegravir + Rilpivirine for HIV Maintenance Therapy: Week 48 Pooled Analysis of Phase 3 ATLAS and FLAIR Trials.,"BACKGROUND
Long-acting (LA) injectable regimens are a potential therapeutic option in people living with HIV-1.
SETTING
ATLAS (NCT02951052) and FLAIR (NCT02938520) were 2 randomized, open-label, multicenter, multinational phase 3 studies.
METHODS
Adult participants with virologic suppression (plasma HIV-1 RNA <50 copies/mL) were randomized (1:1) to continue with their current antiretroviral regimen (CAR) or switch to the long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). In the LA arm, participants initially received oral CAB + RPV once-daily for 4 weeks to assess individual safety and tolerability, before starting monthly injectable therapy. The primary endpoint of this combined analysis was antiviral efficacy at week 48 (FDA Snapshot algorithm: noninferiority margin of 4% for HIV-1 RNA ≥50 copies/mL). Safety, tolerability, and confirmed virologic failure (2 consecutive plasma HIV-1 RNA ≥200 copies/mL) were secondary endpoints.
RESULTS
The pooled intention-to-treat exposed population included 591 participants in each arm [28% women (sex at birth), 19% aged ≥50 years]. Noninferiority criteria at week 48 were met for the primary (HIV-1 RNA ≥50 copies/mL) and key secondary (HIV-1 RNA <50 copies/mL) efficacy endpoints. Seven individuals in each arm (1.2%) developed confirmed virologic failure; 6/7 (LA) and 3/7 (CAR) had resistance-associated mutations. Most LA recipients (83%) experienced injection site reactions, which decreased in incidence over time. Injection site reactions led to the withdrawal of 6 (1%) participants. The serious adverse event rate was 4% in each arm.
CONCLUSION
This combined analysis demonstrates monthly injections of CAB + RPV LA were noninferior to daily oral CAR for maintaining HIV-1 suppression.",2020,"The serious adverse event rate was 4% in each arm.
","['Adult participants with virologic suppression (plasma HIV-1 RNA <50 copies/mL', '591 participants in each arm [28% women (sex at birth), 19% aged ≥50 years', 'HIV Maintenance Therapy', 'people living with HIV-1']","['current antiretroviral regimen (CAR) or switch to the long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV', 'Long-Acting Injectable Cabotegravir + Rilpivirine', 'CAB + RPV LA', 'oral CAB + RPV']","['antiviral efficacy', 'injection site reactions', 'serious adverse event rate', 'individual safety and tolerability', 'Safety, tolerability, and confirmed virologic failure', 'confirmed virologic failure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}]",591.0,0.343785,"The serious adverse event rate was 4% in each arm.
","[{'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Rizzardini', 'Affiliation': 'Department of Infectious Diseases, Fatebenefratelli Sacco Hospital, Milan, Italy.'}, {'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Centre for Immunobiology, Queen Mary University, London, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Swindells', 'Affiliation': 'Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'Keikawus', 'Initials': 'K', 'LastName': 'Arasteh', 'Affiliation': 'EPIMED GmbH, Berlin, Germany.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Górgolas Hernández-Mora', 'Affiliation': 'Fundación Jiménez Díaz-Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Pokrovsky', 'Affiliation': 'Central Research Institute of Epidemiology, Moscow, Russia.'}, {'ForeName': 'Pierre-Marie', 'Initials': 'PM', 'LastName': 'Girard', 'Affiliation': 'Hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Oka', 'Affiliation': 'AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Jaime F', 'Initials': 'JF', 'LastName': 'Andrade-Villanueva', 'Affiliation': 'HIV/AIDS Unit, Hospital Civil de Guadalajara, University Center for Health Sciences, University of Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Richmond', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary Medicine, Broward Health Medical Center, Nova Southeastern University, Fort Lauderdale, FL.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Baumgarten', 'Affiliation': 'Zentrum für Infektiologie Berlin Prenzlauer Berg, Berlin, Germany.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Masiá', 'Affiliation': 'Infectious Diseases Unit, Hospital General de Elche-Universidad Miguel Hernández, Alicante, Spain.'}, {'ForeName': 'Gulam', 'Initials': 'G', 'LastName': 'Latiff', 'Affiliation': 'Maxwell Centre, Durban, South Africa.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Griffith', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Conn M', 'Initials': 'CM', 'LastName': 'Harrington', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Krischan J', 'Initials': 'KJ', 'LastName': 'Hudson', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Marty', 'Initials': 'M', 'LastName': 'St Clair', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Talarico', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cutrell', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Van Eygen', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'DʼAmico', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Mrus', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Sterling', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Ford', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Chow', 'Affiliation': 'GlaxoSmithKline, Mississauga, Ontario, Canada.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wills', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Walters', 'Affiliation': 'GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Vanveggel', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Van Solingen-Ristea', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Herta', 'Initials': 'H', 'LastName': 'Crauwels', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Smith', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Spreen', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Margolis', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002466']
1608,33136770,Higher Peak Fat Oxidation During Rowing vs. Cycling in Active Men and Women.,"Astorino, TA, Oriente, C, Peterson, J, Alberto, G, Castillo, EE, Vasquez-Soto, U, Ibarra, E, Guise, V, Castaneda, I, Marroquin, JR, Dargis, R, and Thum, JS. Higher peak fat oxidation during rowing vs. cycling in active men and women. J Strength Cond Res XX(X): 000-000, 2020-This study compared fat and carbohydrate oxidation (CHOOx) between progressive rowing and cycling. Initially, 22 active healthy adults (age = 27 ± 8 years) performed incremental cycling and rowing to volitional fatigue to assess maximal oxygen uptake (V[Combining Dot Above]O2max) and maximal heart rate (HRmax). The order of 2 subsequent sessions was randomized, performed 2 hours postmeal, and included a warm-up followed by three 8-minute stages of rowing or cycling at 60-65, 70-75, and 80-85 %HRmax. During exercise, power output was modified to maintain work rate in the desired range. Gas exchange data and blood samples were obtained to measure fat and CHOOx and blood lactate concentration. Fat oxidation (FOx) increased during exercise (p < 0.001) and there was a main effect of mode (p = 0.03) but no modeXintensity interaction (p = 0.33). Peak FOx was higher in response to rowing vs. cycling (0.23 ± 0.09 g·min vs. 0.18 ± 0.07 g·min, p = 0.01). Carbohydrate oxidation increased during exercise (p < 0.001) but there was no effect of mode (p = 0.25) or modeXintensity interaction (p = 0.08). Blood lactate concentration was lower (p = 0.007) at the end of rowing vs. cycling (3.1 ± 1.0 mM vs. 3.9 ± 1.6 mM, d = 1.1). Prolonged rowing having equivalent calorie expenditure and intensity vs. cycling elicits higher peak FOx, which is likely attributed to greater muscle mass used during rowing.",2020,Fat oxidation (FOx) increased during exercise (p < 0.001) and there was a main effect of mode (p = 0.03) but no modeXintensity interaction (p = 0.33).,"['22 active healthy adults (age = 27 ± 8 years) performed', 'active men and women', 'Active Men and Women']","['fat and carbohydrate oxidation (CHOOx) between progressive rowing and cycling', 'incremental cycling and rowing to volitional fatigue to assess maximal oxygen uptake ', 'V[Combining']","['maximal heart rate (HRmax', 'Astorino, TA, Oriente, C, Peterson, J, Alberto, G, Castillo, EE, Vasquez-Soto, U, Ibarra, E, Guise, V, Castaneda, I, Marroquin, JR, Dargis, R, and Thum, JS', 'Fat oxidation (FOx', 'Higher peak fat oxidation', 'Higher Peak Fat Oxidation', 'Blood lactate concentration', 'Carbohydrate oxidation', 'fat and CHOOx and blood lactate concentration', 'Peak FOx']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]",22.0,0.0690565,Fat oxidation (FOx) increased during exercise (p < 0.001) and there was a main effect of mode (p = 0.03) but no modeXintensity interaction (p = 0.33).,"[{'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Astorino', 'Affiliation': 'Department of Kinesiology, California State University, San Marcos, California.'}, {'ForeName': 'Chandler', 'Initials': 'C', 'LastName': 'Oriente', 'Affiliation': ''}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Peterson', 'Affiliation': ''}, {'ForeName': 'Giannina', 'Initials': 'G', 'LastName': 'Alberto', 'Affiliation': ''}, {'ForeName': 'Erica Elena', 'Initials': 'EE', 'LastName': 'Castillo', 'Affiliation': ''}, {'ForeName': 'Ulices', 'Initials': 'U', 'LastName': 'Vasquez-Soto', 'Affiliation': ''}, {'ForeName': 'Esmerelda', 'Initials': 'E', 'LastName': 'Ibarra', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Guise', 'Affiliation': ''}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Castaneda', 'Affiliation': ''}, {'ForeName': 'Joel R', 'Initials': 'JR', 'LastName': 'Marroquin', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dargis', 'Affiliation': ''}, {'ForeName': 'Jacob S', 'Initials': 'JS', 'LastName': 'Thum', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003888']
1609,33136781,"Efficacy of i3.1 Probiotic on Improvement of Lactose Intolerance Symptoms: A Randomized, Placebo-controlled Clinical Trial.","GOAL
The aim of this study was to assess the efficacy of probiotic i3.1 in improving lactose intolerance symptoms compared with placebo after 8 weeks of treatment.
BACKGROUND
Probiotics are promising strategies to prevent and improve lactose intolerance symptoms, but previous studies have provided conflicting results.
MATERIALS AND METHODS
This randomized, prospective, placebo-controlled study was conducted at the Hospital Juárez de México. We recruited adult patients with lactose intolerance confirmed by a lactose hydrogen breath test (LHBT) ≥20 parts per million (ppm) and a lactose intolerance symptom score ≥6 both upon lactose challenge. We compared the change from baseline in the scores of a validated symptom questionnaire and the LHBT after 8 weeks of probiotic or placebo treatment.
RESULTS
We included 48 patients: 33 receiving the probiotic and 15 receiving placebo (2:1 randomization). Demographic characteristics were homogeneous between groups. The reduction in total symptom score after a lactose challenge was significantly higher in the probiotic group versus the placebo group (-5.11 vs. -1.00; P<0.001). All the subscores significantly decreased from baseline in the probiotic group, except for vomiting, with significant differences between the probiotic and placebo groups for abdominal pain (P=0.045) and flatulence (P=0.004). The area under the curve of the LHBT was significantly reduced from baseline in the probiotic group (P=0.019), but differences between groups were not significant (P=0.621). Adverse events were mild without differences between groups, and no serious adverse event was registered.
CONCLUSION
The i3.1 probiotic was safe and efficacious in reducing lactose intolerance symptoms in patients with lactose intolerance, but did not change the LHBT.",2020,"All the subscores significantly decreased from baseline in the probiotic group, except for vomiting, with significant differences between the probiotic and placebo groups for abdominal pain (P=0.045) and flatulence (P=0.004).","['patients with lactose intolerance', '48 patients: 33 receiving the probiotic and 15 receiving placebo (2:1 randomization', 'adult patients with lactose intolerance confirmed by a lactose hydrogen breath test (LHBT) ≥20\u2009parts per million (ppm) and a lactose intolerance symptom score ≥6 both upon lactose challenge']","['placebo', 'Placebo', 'i3.1 Probiotic']","['Lactose Intolerance Symptoms', 'Adverse events', 'lactose intolerance symptoms', 'abdominal pain', 'total symptom score', 'flatulence', 'area under the curve of the LHBT', 'vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022951', 'cui_str': 'Intolerance to lactose'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0344439', 'cui_str': 'Hydrogen breath test'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0022951', 'cui_str': 'Intolerance to lactose'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0344439', 'cui_str': 'Hydrogen breath test'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",48.0,0.340677,"All the subscores significantly decreased from baseline in the probiotic group, except for vomiting, with significant differences between the probiotic and placebo groups for abdominal pain (P=0.045) and flatulence (P=0.004).","[{'ForeName': 'Ana D', 'Initials': 'AD', 'LastName': 'Cano-Contreras', 'Affiliation': 'Gastroenterology Department, Hospital Juarez de Mexico, Mexico City.'}, {'ForeName': 'Isidro J', 'Initials': 'IJ', 'LastName': 'Minero Alfaro', 'Affiliation': 'Gastroenterology Department, Hospital Juarez de Mexico, Mexico City.'}, {'ForeName': 'Víctor M', 'Initials': 'VM', 'LastName': 'Medina López', 'Affiliation': 'Gastroenterology Department, Hospital Juarez de Mexico, Mexico City.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Amieva Balmori', 'Affiliation': 'Digestive Physiology and Gastrointestinal Motility Laboratory, Medical-Biological Research Institute, Veracruzana University, Veracruz, Mexico.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Remes Troche', 'Affiliation': 'Digestive Physiology and Gastrointestinal Motility Laboratory, Medical-Biological Research Institute, Veracruzana University, Veracruz, Mexico.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Espadaler Mazo', 'Affiliation': 'AB-Biotics S.A (KANEKA Group), ESADE Creapolis, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Perez Lopez', 'Affiliation': 'Gastroenterology Department, Hospital Juarez de Mexico, Mexico City.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001456']
1610,33136786,Usefulness of Tranexamic Acid Administration During Sagittal Split Ramus Osteotomy.,"Tranexamic acid has been used to reduce intraoperative bleeding; however, its effect on anti-inflammation and the amount of drainage after orthognathic surgery is yet to be determined. Therefore, we aimed to examine the effect of tranexamic acid on intraoperative bleeding volume and operation time, amount of drainage, and anti-inflammation after orthognathic surgery. Forty healthy women who underwent bilateral sagittal split ramus osteotomy under general anesthesia participated in this study. The amount of intraoperative bleeding, the operation time, the amount of drainage, and the C-reactive protein level were compared between patients intravenously administered with tranexamic acid before surgery (before-surgery group) and those administered with the drug after surgery (after-surgery group). All data were analyzed using the Student t-test. Results were considered to be statistically significant when P < 0.05. Although no significant difference was found in the amount of drainage between the groups (P > 0.05), significant variations were detected in the amount of bleeding during surgery (before-surgery group: 161.7 ± 45.3 mL versus after-surgery group: 270.2 ± 24.0 mL; P = 0.0009), operation time (before-surgery group: 141.3 ± 16.8 min versus after-surgery group: 166.8 ± 24.9 min; P = 0.03), and postoperative C-reactive protein level (before-surgery group: 3.77 ± 0.40 mg/dL versus after-surgery group: 5.02 ± 0.75 mg/dL; P = 0.012) between the groups. In conclusion, administering tranexamic acid before surgery was found to significantly decrease bleeding, reduce operation time, and suppress postoperative inflammation.",2020,"Although no significant difference was found in the amount of drainage between the groups (P > 0.05), significant variations were detected in the amount of bleeding during surgery (before-surgery group: 161.7 ± 45.3 mL versus after-surgery group: 270.2 ± 24.0 mL; P = 0.0009), operation time (before-surgery group: 141.3 ± 16.8 min versus after-surgery group: 166.8 ± 24.9 min; P = 0.03), and postoperative C-reactive protein level (before-surgery group: 3.77 ± 0.40 mg/dL versus after-surgery group: 5.02 ± 0.75 mg/dL; P = 0.012) between the groups.","['after orthognathic surgery', 'Forty healthy women who underwent bilateral sagittal split ramus osteotomy under general anesthesia participated in this study']","['Tranexamic Acid Administration', 'tranexamic acid', 'Tranexamic acid']","['intraoperative bleeding volume and operation time, amount of drainage, and anti-inflammation', 'intraoperative bleeding, the operation time, the amount of drainage, and the C-reactive protein level', 'amount of drainage', 'operation time', 'bleeding, reduce operation time, and suppress postoperative inflammation', 'postoperative C-reactive protein level', 'amount of bleeding during surgery', 'intraoperative bleeding']","[{'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3178772', 'cui_str': 'Sagittal Split Ramus Osteotomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",40.0,0.0289687,"Although no significant difference was found in the amount of drainage between the groups (P > 0.05), significant variations were detected in the amount of bleeding during surgery (before-surgery group: 161.7 ± 45.3 mL versus after-surgery group: 270.2 ± 24.0 mL; P = 0.0009), operation time (before-surgery group: 141.3 ± 16.8 min versus after-surgery group: 166.8 ± 24.9 min; P = 0.03), and postoperative C-reactive protein level (before-surgery group: 3.77 ± 0.40 mg/dL versus after-surgery group: 5.02 ± 0.75 mg/dL; P = 0.012) between the groups.","[{'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Section of Dental Anesthesiology, Department of Oral and Maxillofacial Surgery and Oral Medicine, Hiroshima University Hospital, Hiroshima.'}, {'ForeName': 'Shigehiro', 'Initials': 'S', 'LastName': 'Ono', 'Affiliation': 'Department of Oral and Maxillofacial Surgery.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Department of Dental Anesthesiology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Oue', 'Affiliation': 'Section of Dental Anesthesiology, Department of Oral and Maxillofacial Surgery and Oral Medicine, Hiroshima University Hospital, Hiroshima.'}, {'ForeName': 'Akari', 'Initials': 'A', 'LastName': 'Mukai', 'Affiliation': 'Department of Dental Anesthesiology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Doi', 'Affiliation': 'Department of Dental Anesthesiology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Irifune', 'Affiliation': 'Department of Dental Anesthesiology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000007019']
1611,33136819,A Pragmatic Randomized Controlled Trial to Increase Pre-Exposure Prophylaxis Uptake for HIV prevention: 55-week results from PrEPChicago.,"BACKGROUND
We tested efficacy of a peer change agent Type I network intervention to increase PrEP linkage to care among network members connected to young Black men who have sex with men.
METHODS
We randomly assigned 423 participants in Chicago to receive the network intervention, an opinion leader workshop with telephonic booster sessions, versus a time-matched control from 2016-2018. The consolidated surrogate outcome was PrEP referral and linkage to clinical care among network members connected to study participants and was collected from independent administrative data.
RESULTS
Each study participant in the trial (n=423) had on average 1822 network contacts who could be eligible for PrEP referral and linkage. During the 55-week observation period PrEP referral was most likely to occur within 3 days of an intervention session compared to control (OR 0.07 (0.02-0.013); p=0.007) resulting in 1-2 referrals of network members per session. Network members with referral or linkage were more likely to be connected to study participants in the intervention arm than the control condition (aOR 1.50 (1.09-2.06); p=0.012).
CONCLUSIONS
A peer change agent Type I network intervention is effective at diffusing PrEP through a network of individuals highly susceptible to HIV over 55 weeks of follow-up. This low intensity intervention demonstrated preliminary network level impact among populations that have experienced limited PrEP care engagement in the United States.",2020,A peer change agent Type I network intervention is effective at diffusing PrEP through a network of individuals highly susceptible to HIV over 55 weeks of follow-up.,"['423 participants in Chicago to receive the', 'HIV prevention', 'young Black men who have sex with men', 'Each study participant in the trial (n=423) had on average 1822 network contacts who could be eligible for PrEP referral and linkage']","['network intervention, an opinion leader workshop with telephonic booster sessions', 'peer change agent Type I network intervention']",[],"[{'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]","[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]",[],423.0,0.122145,A peer change agent Type I network intervention is effective at diffusing PrEP through a network of individuals highly susceptible to HIV over 55 weeks of follow-up.,"[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Schneider', 'Affiliation': 'University of Chicago, Chicago IL.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Young', 'Affiliation': 'University of Chicago, Chicago IL.'}, {'ForeName': 'Arthi', 'Initials': 'A', 'LastName': 'Ramachandran', 'Affiliation': 'University of Chicago, Chicago IL.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Michaels', 'Affiliation': 'NORC at the University of Chicago, Chicago IL.'}, {'ForeName': 'Hildie', 'Initials': 'H', 'LastName': 'Cohen', 'Affiliation': 'NORC at the University of Chicago, Chicago IL.'}, {'ForeName': 'Ishida', 'Initials': 'I', 'LastName': 'Robinson', 'Affiliation': 'NORC at the University of Chicago, Chicago IL.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Alon', 'Affiliation': 'University of Chicago, Chicago IL.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Hill', 'Affiliation': 'University of Chicago, Chicago IL.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nakasone', 'Affiliation': 'University of Chicago, Chicago IL.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Balenciaga', 'Affiliation': 'University of Chicago, Chicago IL.'}, {'ForeName': 'Darnell', 'Initials': 'D', 'LastName': 'Motley', 'Affiliation': 'University of Chicago, Chicago IL.'}, {'ForeName': 'Alida', 'Initials': 'A', 'LastName': 'Bouris', 'Affiliation': 'University of Chicago, Chicago IL.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Khanna', 'Affiliation': 'University of Chicago, Chicago IL.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Ferreira', 'Affiliation': 'University of Chicago, Chicago IL.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Valente', 'Affiliation': 'University of Southern California, Los Angeles CA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Schumm', 'Affiliation': 'University of Chicago, Chicago IL.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002518']
1612,33136871,Cleft Palate Repair: A Study Between Two Surgical Procedures.,"OBJECTIVE
The purpose of this study was to categorize and compare outcomes and sequels in 2 groups of patients born with unilateral and bilateral complete cleft lip/palate, having their primary cleft palate repair performed in our hospital, by the same surgical team, during 2 different periods of time, to establish which of the 2 surgical reconstructive strategies employed was more effective to decrease sequels.
MATERIAL AND METHODS
This is a randomized clinical trial including a total of 291, nonsyndromic patients, primary assisted in our Hospital, between 2002 and 2013, and operated by the same senior surgeon.Two groups of patients of similar characteristics were treated utilizing 2 different surgical procedures according to the considered period. Isolated palates, syndromic patients, secondary and adult cases were considered as exclusion critters. Surgical data was obtained from medical records, and clinical examinations. All the patients were cautiously evaluated by a team expert to verify results, evolution, and sequels.
RESULTS
Statistically significant differences in the total percentage of complications were found between both groups. Group A: 54.85% and Group B: 21.90% (P value < 0.001).Each complication was also considered by groups and estimated as follow: CONCLUSIONS:: Based on the results of our research, we can suggest the Carstens' variant plus the introduced modifications by the authors, as a useful surgical procedure to be utilized in primary complete unilateral or bilateral cleft palate repair to prevent post op common complications.",2020,Group A: 54.85% and Group B: 21.90% (P value < 0.001).Each complication was also considered by groups and estimated as follow:,"['total of 291, nonsyndromic patients, primary assisted in our Hospital, between 2002 and 2013, and operated by the same senior surgeon', '2 groups of patients born with unilateral and bilateral complete cleft lip/palate, having their primary cleft palate repair performed in our hospital, by the same surgical team', 'Cleft Palate Repair']",[],['total percentage of complications'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0158653', 'cui_str': 'Complete bilateral cleft lip'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0192086', 'cui_str': 'Repair of cleft palate'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0367061,Group A: 54.85% and Group B: 21.90% (P value < 0.001).Each complication was also considered by groups and estimated as follow:,"[{'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Astrada', 'Affiliation': 'Asociacion PIEL.'}, {'ForeName': 'Ricardo D', 'Initials': 'RD', 'LastName': 'Bennun', 'Affiliation': 'Asociacion PIEL.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006814']
1613,33136923,Effect of Brexpiprazole on Prolactin and Sexual Functioning: An Analysis of Short- and Long-Term Study Data in Major Depressive Disorder.,"PURPOSE/BACKGROUND
Evidence supports use of adjunctive atypical antipsychotics in major depressive disorder (MDD). Impaired sexual functioning is common in MDD and may be worsened by antipsychotic adverse effects. We evaluated the effect of brexpiprazole on prolactin and sexual functioning in patients with MDD.
METHODS/PROCEDURES
In short-term studies, patients received adjunctive brexpiprazole 1, 2, or 3 mg or placebo. The long-term study was a flexible-dose (0.5-3 mg/d) open-label extension (OLE). Change from baseline and shifts in prolactin status and prolactin-related treatment-emergent adverse events (TEAEs) were assessed. Sexual functioning was assessed by the Massachusetts General Hospital Sexual Functioning Questionnaire.
FINDINGS/RESULTS
Median changes in prolactin levels from baseline to week 6 in short-term studies were as follows: brexpiprazole, 5.99 ng/mL (females) and 1.61 ng/mL (males); placebo, -0.15 ng/mL (females) and -0.08 ng/mL (males).Median changes from baseline to week 52 in the OLE were as follows: 0.27 ng/mL (females) and 0.27 ng/mL (males). Prolactin levels in patients with baseline prolactin greater than 1× upper limit of normal values tended to decrease over time.The proportion of brexpiprazole-treated patients with greater than 3× upper limit of normal postbaseline prolactin values in short-term studies for both sexes was low (0%-0.3%) and did not differ from placebo: OLE, 0.5% (females) and 0.8% (males).In short-term studies, the incidence of prolactin-related TEAEs was 3.1% for brexpiprazole and 0.7% for placebo (OLE, 3.1%). There were overall numerical improvements from baseline in sexual functioning for females and males after short- and long-term brexpiprazole treatment, with statistically significant improvements for brexpiprazole versus placebo in females on the items 'interest in sex' (-0.19; 95% confidence interval [CI], -0.33 to -0.05; P = 0.0074), 'sexually aroused' (-0.17; 95% CI, -0.30 to -0.03; P = 0.0154), and 'overall sexual satisfaction' (-0.16; 95% CI, -0.30 to -0.03; P = 0.0184).
IMPLICATIONS/CONCLUSIONS
There were small changes in prolactin levels, low proportions of patients with postbaseline elevated prolactin values, low incidences of prolactin-related TEAEs, and modest improvements in sexual functioning with adjunctive brexpiprazole in MDD.",2020,"There were overall numerical improvements from baseline in sexual functioning for females and males after short- and long-term brexpiprazole treatment, with statistically significant improvements for brexpiprazole versus placebo in females on the items 'interest in sex' (-0.19; 95% confidence interval [CI], -0.33 to -0.05; P = 0.0074), 'sexually aroused' (-0.17; 95% CI, -0.30 to -0.03; P = 0.0154), and 'overall sexual satisfaction' (-0.16; 95% CI, -0.30 to -0.03; P = 0.0184).
","['Major Depressive Disorder', 'major depressive disorder (MDD', 'patients with MDD']","['placebo: OLE', 'adjunctive atypical antipsychotics', 'placebo', 'Brexpiprazole', 'brexpiprazole', 'adjunctive brexpiprazole']","['prolactin status and prolactin-related treatment-emergent adverse events (TEAEs', 'prolactin levels', 'overall sexual satisfaction', 'incidence of prolactin-related TEAEs', 'Massachusetts General Hospital Sexual Functioning Questionnaire', 'Prolactin and Sexual Functioning', 'Prolactin levels', 'sexual functioning', 'prolactin and sexual functioning', 'Sexual functioning', 'normal postbaseline prolactin values']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C3885614', 'cui_str': 'brexpiprazole'}]","[{'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.265903,"There were overall numerical improvements from baseline in sexual functioning for females and males after short- and long-term brexpiprazole treatment, with statistically significant improvements for brexpiprazole versus placebo in females on the items 'interest in sex' (-0.19; 95% confidence interval [CI], -0.33 to -0.05; P = 0.0074), 'sexually aroused' (-0.17; 95% CI, -0.30 to -0.03; P = 0.0154), and 'overall sexual satisfaction' (-0.16; 95% CI, -0.30 to -0.03; P = 0.0184).
","[{'ForeName': 'Anita H', 'Initials': 'AH', 'LastName': 'Clayton', 'Affiliation': 'From the Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Ivkovic', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Dalei', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, NJ.'}, {'ForeName': 'Vinu', 'Initials': 'V', 'LastName': 'George', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, NJ.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hobart', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, NJ.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001297']
1614,33136966,Targeted Muscle Reinnervation as a Solution for Nerve Pain.,"LEARNING OBJECTIVES
After reading this article, the participants should be able to: 1. List current nonsurgical and surgical strategies for addressing postamputation neuroma pain and discuss their limitations. 2. Summarize the indications and rationale for targeted muscle reinnervation. 3. Develop an operative plan for targeted muscle reinnervation in an acute or delayed fashion for upper and lower extremity amputations. 4. Propose a management algorithm for treatment of symptomatic neuromas in an intact limb. 5. Discuss the risk of neuroma development after primary revision digital amputation or secondary surgery for a digital neuroma. 6. Compare and contrast targeted muscle reinnervation to the historical gold standard neuroma treatment of excision and burying the involved nerve in muscle, bone, or vein graft. 7. Interpret and discuss the evidence that targeted muscle reinnervation improves postamputation neuroma and phantom pain when performed either acutely or in a delayed fashion to treat existing pain.
SUMMARY
Symptomatic injured nerves resulting from amputations, extremity trauma, or prior surgery are common and can decrease patient quality of life, thus necessitating an effective strategy for management. Targeted muscle reinnervation is a modern surgical strategy for prevention and treatment of neuroma pain that promotes nerve regeneration and healing rather than neuroma formation. Targeted muscle reinnervation involves the transfer of cut peripheral nerves to small motor nerves of adjacent, newly denervated segments of muscle and can be easily performed without specialized equipment. Targeted muscle reinnervation strategies exist for both upper and lower extremity amputations and for symptomatic neuromas of intact limbs. Targeted muscle reinnervation has been shown in a prospective, randomized, controlled trial to result in lower neuroma and phantom pain when compared to the historical gold standard of burying cut nerves in muscle.",2020,Targeted muscle reinnervation strategies exist for both upper and lower extremity amputations and for symptomatic neuromas of intact limbs.,['primary revision digital amputation or secondary surgery for a digital neuroma'],[],['patient quality of life'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027858', 'cui_str': 'Neuroma'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0280288,Targeted muscle reinnervation strategies exist for both upper and lower extremity amputations and for symptomatic neuromas of intact limbs.,"[{'ForeName': 'Steven T', 'Initials': 'ST', 'LastName': 'Lanier', 'Affiliation': 'Chicago, Ill. From the Division of Plastic Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine.'}, {'ForeName': 'Sumanas W', 'Initials': 'SW', 'LastName': 'Jordan', 'Affiliation': ''}, {'ForeName': 'Jason H', 'Initials': 'JH', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Dumanian', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007235']
1615,33137013,Does Fixation of Gastric Sleeve Prevent Functional Stenosis in Sleeve Gastrectomy Patients?,"AIM
The aim of this study is to determine whether gastric sleeve fixation prevents functional stenosis (twist or kink) and to investigate its effects on symptoms such as nausea and vomiting after laparoscopic sleeve gastrectomy (LSG).
METHODS
A total of 717 patients who underwent primary LSG for morbid obesity and completed at least 1 year of follow-up between 2012 and 2019 were included in the study. All operations were performed by the same surgical team using the same technique. The patients were divided into 2 groups, that is, group 1: standard LSG and group 2: gastric sleeve fixation with LSG. These 2 groups were compared in terms of demographic characteristics, baseline body mass index, follow-up duration, bleeding, leaks, gastric stenosis, postoperative nausea, vomiting, and the need for antiemetics. In the follow-up period, patients with suspected gastric stenosis underwent endoscopy and upper gastrointestinal series.
RESULTS
LSG was performed in 717 patients (55.2% female) with a mean age of 37.8±11.5 years and a median body mass index of 42.2 (30.2 to 74.2) kg/m. The 241 patients in the first group underwent LSG without fixation, and the 476 patients in the second group with fixation. Functional stenosis was detected in 8 patients, all of whom were in group 1. One patient in group 1 had a leak on the background of functional stenosis. There was bleeding that required transfusion in 2 patients (group 1) and reoperation in 2 patients (group 2). None of the study patients died. During the in-hospital period, 122 (50.6%) patients in group 1 and 159 (33.4%) patients in group 2 had nausea and vomiting that required antiemetic treatment (P<0.001).
CONCLUSION
Gastric sleeve fixation in LSG prevents complications that may arise because of improper gastric mobilization. This method is effective in reducing nausea and vomiting in LSG patients.",2020,There was bleeding that required transfusion in 2 patients (group 1) and reoperation in 2 patients (group 2).,"['241 patients in the first group underwent LSG without fixation, and the 476 patients in the second group with fixation', 'LSG patients', 'patients with suspected gastric stenosis underwent endoscopy and upper gastrointestinal series', '717 patients who underwent primary LSG for morbid obesity and completed at least 1 year of follow-up between 2012 and 2019 were included in the study', 'Sleeve Gastrectomy Patients', '717 patients (55.2% female) with a mean age of 37.8±11.5 years and a median body mass index of 42.2 (30.2 to 74.2)\u2009kg/m']","['gastric sleeve fixation', 'Gastric Sleeve', 'laparoscopic sleeve gastrectomy (LSG', 'Gastric sleeve fixation in LSG', 'standard LSG and group 2: gastric sleeve fixation with LSG']","['bleeding that required transfusion', 'Functional stenosis', 'leak on the background of functional stenosis', 'nausea and vomiting', 'demographic characteristics, baseline body mass index, follow-up duration, bleeding, leaks, gastric stenosis, postoperative nausea, vomiting, and the need for antiemetics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0585012', 'cui_str': 'Stenosis of stomach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0203057', 'cui_str': 'Upper gastrointestinal tract series'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C4758637', 'cui_str': 'Gastric sleeve'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0585012', 'cui_str': 'Stenosis of stomach'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}]",717.0,0.0180489,There was bleeding that required transfusion in 2 patients (group 1) and reoperation in 2 patients (group 2).,"[{'ForeName': 'Ozan', 'Initials': 'O', 'LastName': 'Şen', 'Affiliation': 'Department of Health Sciences, Nişantaşi University.'}, {'ForeName': 'Ümit', 'Initials': 'Ü', 'LastName': 'Sekmen', 'Affiliation': 'School of Health Sciences, Acibadem Universty, İstanbul, Turkey.'}, {'ForeName': 'Ahmet G', 'Initials': 'AG', 'LastName': 'Türkçapar', 'Affiliation': 'Türkçapar Bariatrics, Obesity Center.'}, {'ForeName': 'Mehmet A', 'Initials': 'MA', 'LastName': 'Yerdel', 'Affiliation': 'İstanbul Bariatrics, Obesity and Advanced Laparoscopy Center.'}]","Surgical laparoscopy, endoscopy & percutaneous techniques",['10.1097/SLE.0000000000000869']
1616,33137100,"Baseline patterns of infection in regions of Benin, Malawi and India seeking to interrupt transmission of soil transmitted helminths (STH) in the DeWorm3 trial.","Global efforts to control morbidity associated with soil-transmitted helminth infections (STH) have focused largely on the targeted treatment of high-risk groups, including children and pregnant women. However, it is not clear when such programs can be discontinued and there are concerns about the sustainability of current STH control programs. The DeWorm3 project is a large multi-country community cluster randomized trial in Benin, India and Malawi designed to determine the feasibility of interrupting the transmission of STH using community-wide delivery of mass drug administration (MDA) with anthelmintics over multiple rounds. Here, we present baseline data and estimate key epidemiological parameters important in determining the likelihood of transmission interruption in the DeWorm3 trial. A baseline census was conducted in October-December 2017 in India, November-December 2017 in Malawi and in January-February 2018 in Benin. The baseline census enumerated all members of each household and collected demographic data and information on occupation, assets, and access to water, sanitation and hygiene (WASH). Each study site was divided into 40 clusters of at least 1,650 individuals per cluster. Clusters were randomized to receive twice yearly community-wide MDA with albendazole (GSK) targeting eligible individuals of all ages (20 clusters), or to receive the standard-of-care deworming program targeting children provided in each country. In each site, a randomly selected group of 150 individuals per cluster (6,000 total per site) was selected from the baseline census using stratified random sampling, and each individual provided a single stool sample for analysis of STH infection using the Kato-Katz technique. Study site, household and individual characteristics were summarized as appropriate. We estimated key epidemiological parameters including the force of infection and the degree of parasite aggregation within the population. The DeWorm3 sites range in population from 94,969 to 140,932. The population age distribution varied significantly by site, with the highest proportion of infants and young children in Malawi and the highest proportion of adults in India. The baseline age- and cluster-weighted prevalence, as measured by Kato-Katz, varied across sites and by species, Baseline hookworm prevalence in India was 21.4% (95% CI: 20.4-22.4%), while prevalence of Ascaris and Trichuris by Kato-Katz was low (0.1% and 0.3% overall). In Malawi, the overall age- and cluster-weighted STH prevalence was 7.7% (95% CI: 7.1-8.4%) predominantly driven by hookworm infections (7.4%) while Ascaris (0.1%) and Trichuris (0.3%) infections were rare. In Benin, the overall age- and cluster-weighted prevalence was significantly lower (5.6%, 95% CI: 5.1-6.2%) and Ascaris (2.0%, 95% CI: 1.6-2.3%) was more common than in other sites. Ascaris infections were more likely to be moderate- or heavy-intensity (43.7%, unweighted) compared to hookworm (5.0%). The force of infection for hookworm was highest in adults in India and Malawi but appeared relatively stable across age groups in Benin. These data demonstrate the significant variability between the sites in terms of demography, socio-economic status and environmental characteristics. In addition, the baseline prevalence and intensity data from DeWorm3 suggest that each site has unique epidemiologic characteristics that will be critical in determining correlates of achieving STH transmission interruption in the DeWorm3 trial. Trial registration: The trial was registered at ClinicalTrials.gov (NCT03014167).",2020,The force of infection for hookworm was highest in adults in India and Malawi but appeared relatively stable across age groups in Benin.,"['October-December 2017 in India, November-December 2017 in Malawi and in January-February 2018 in Benin', 'Each study site was divided into 40 clusters of at least 1,650 individuals per cluster', 'children and pregnant women']","['albendazole (GSK', 'standard-of-care deworming program targeting children provided in each country']","['Ascaris infections', 'prevalence of Ascaris and Trichuris by Kato-Katz', 'demographic data and information on occupation, assets, and access to water, sanitation and hygiene (WASH', 'hookworm infections', 'overall age- and cluster-weighted STH prevalence', 'overall age- and cluster-weighted prevalence', 'force of infection for hookworm', 'Ascaris']","[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0005005', 'cui_str': 'Benin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0199859', 'cui_str': 'Deworming'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0003950', 'cui_str': 'Ascariasis'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0003954', 'cui_str': 'Ascaris'}, {'cui': 'C0040955', 'cui_str': 'Trichuris'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0019911', 'cui_str': 'Disease due to superfamily Ancylostomatoidea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0018889', 'cui_str': 'Helminth infection'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0002830', 'cui_str': 'Superfamily ancylostomatoidea'}]",,0.128256,The force of infection for hookworm was highest in adults in India and Malawi but appeared relatively stable across age groups in Benin.,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008771']
1617,33137103,IMARA: A mother-daughter group randomized controlled trial to reduce sexually transmitted infections in Black/African-American adolescents.,"Black/African-American girls are infected with sexually transmitted infections (STIs) at higher rates than their White counterparts. This study tested the efficacy of IMARA, a mother-daughter psychosocial STI/HIV prevention program, on adolescent Black/African-American girls' incident STIs at 12 months in a 2-arm group randomized controlled trial. Black/African-American girls 14-18 years old and their primary female caregiver were eligible for the study. Girls provided urine samples to test for N. gonorrhoeae, C. trachomatis, and T. vaginalis infection at baseline and 12-months. Mother-daughter dyads were randomly assigned to IMARA (n = 118) or a time-matched health promotion control program (n = 81). Retention at 12-months was 86% with no difference across arms. Both interventions were delivered over two consecutive Saturdays totaling 12 hours. Girls who received IMARA were 43% less likely to contract a new STI in the 12-month post-intervention period compared with those in the health promotion control program (p = .011). A secondary follow-up intent-to-treat analysis provided additional support for the protective effect of IMARA, albeit with a similar magnitude of 37% (p = .014). Findings provide early evidence for IMARA's efficacy, such that IMARA protected against STIs at 12-months among adolescent Black/African-American girls. Future research should examine the mechanisms associated with reduced STIs.",2020,Girls who received IMARA were 43% less likely to contract a new STI in the 12-month post-intervention period compared with those in the health promotion control program (p = .011).,"['adolescent Black/African-American girls', 'Black/African-American adolescents', 'Black/African-American girls', 'Mother-daughter dyads', 'Black/African-American girls 14-18 years old and their primary female caregiver were eligible for the study']","['IMARA', 'time-matched health promotion control program', 'IMARA, a mother-daughter psychosocial STI/HIV prevention program']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",[],,0.0502021,Girls who received IMARA were 43% less likely to contract a new STI in the 12-month post-intervention period compared with those in the health promotion control program (p = .011).,"[{'ForeName': 'Geri R', 'Initials': 'GR', 'LastName': 'Donenberg', 'Affiliation': 'Center for Dissemination and Implementation Science, Department of Medicine, College of Medicine, University of Illinois at Chicago, Chicago, Illinois, United States of America.'}, {'ForeName': 'Ashley D', 'Initials': 'AD', 'LastName': 'Kendall', 'Affiliation': 'Center for Dissemination and Implementation Science, Department of Medicine, College of Medicine, University of Illinois at Chicago, Chicago, Illinois, United States of America.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Emerson', 'Affiliation': 'Center for Dissemination and Implementation Science, Department of Medicine, College of Medicine, University of Illinois at Chicago, Chicago, Illinois, United States of America.'}, {'ForeName': 'Faith E', 'Initials': 'FE', 'LastName': 'Fletcher', 'Affiliation': 'School of Public Health, University of Illinois at Chicago, Chicago, Illinois, United States of America.'}, {'ForeName': 'Bethany C', 'Initials': 'BC', 'LastName': 'Bray', 'Affiliation': 'Center for Dissemination and Implementation Science, Department of Medicine, College of Medicine, University of Illinois at Chicago, Chicago, Illinois, United States of America.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'McCabe', 'Affiliation': 'Center for Dissemination and Implementation Science, Department of Medicine, College of Medicine, University of Illinois at Chicago, Chicago, Illinois, United States of America.'}]",PloS one,['10.1371/journal.pone.0239650']
1618,33130217,"Comparing Nanoparticle Polymeric Micellar Paclitaxel and Solvent-based Paclitaxel as First-line Treatment of Advanced Non-Small Cell Lung Cancer: An Open-label, Randomized, Multicenter, Phase III Trial.","BACKGROUND
Polymeric micellar paclitaxel (pm-Pac) is a novel Cremophor EL (CrEL)-free, nanoparticle micellar formulation of paclitaxel. We aimed to compare the efficacy and safety between pm Pac plus cisplatin and sb-Pac (solvent-based paclitaxel) plus cisplatin in advanced non-small cell lung cancer (NSCLC).
PATIENTS AND METHODS
448 stage IIIB to IV NSCLC patients were randomly assigned (2:1) to receive six 3-week cycles of either pm-Pac (230 mg/m 2 ) plus cisplatin (70 mg/m 2 ) (n=300), followed by dose escalation of pm-Pac to 300 mg/m 2 from the second 3-week cycle if prespecified toxic effects were not observed after the first cycle, or sb-Pac (175 mg/m 2 ) plus cisplatin (70 mg/m 2 ) (n=148). The primary endpoint was objective response rate (ORR) assessed by independent review committees (IRC). The secondary endpoints included IRC-assessed progression-free survival (PFS), overall survival (OS), and safety.
RESULTS
Patients in the pm-Pac-plus-cisplatin group showed significant improvements in IRC-assessed ORR compared to those in the sb-Pac-plus-cisplatin group (50% vs. 26%; RR 1.91; p<0.0001). Additionally, subgroup analysis showed that a higher ORR was consistently observed in both squamous and non-squamous histological types. IRC-assessed median PFS was significantly higher in the pm-Pac-plus-cisplatin group than in the sb-Pac-plus-cisplatin group (6.4-months vs. 5.3-months) (hazard ratio [HR] 0.63; p=0.0001). Median OS was not significantly different between the two groups. The incidence of treatment-related serious adverse events (9% vs. 18%; p=0.0090) was significantly lower in the pm-Pac-plus-cisplatin group than in the sb-Pac-plus-cisplatin group.
CONCLUSION
Pm-Pac plus cisplatin yielded superior ORR and PFS along with a favorable safety profile and should become an option for patients with advanced NSCLC.",2020,"The incidence of treatment-related serious adverse events (9% vs. 18%; p=0.0090) was significantly lower in the pm-Pac-plus-cisplatin group than in the sb-Pac-plus-cisplatin group.
","['patients with advanced NSCLC', 'advanced non-small cell lung cancer (NSCLC', '448 stage IIIB to IV NSCLC patients', 'Advanced', 'Non-Small Cell Lung Cancer']","['Nanoparticle Polymeric Micellar Paclitaxel and Solvent-based Paclitaxel', 'cisplatin', 'paclitaxel', 'pm-Pac-plus-cisplatin', 'sb-Pac-plus-cisplatin', 'pm Pac plus cisplatin and sb-Pac (solvent-based paclitaxel) plus cisplatin', 'Polymeric micellar paclitaxel (pm-Pac', 'pm-Pac']","['IRC-assessed progression-free survival (PFS), overall survival (OS), and safety', 'objective response rate (ORR) assessed by independent review committees (IRC', 'efficacy and safety', 'ORR', 'incidence of treatment-related serious adverse events', 'IRC-assessed ORR', 'Median OS', 'IRC-assessed median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}]","[{'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0037638', 'cui_str': 'Solvent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",448.0,0.144124,"The incidence of treatment-related serious adverse events (9% vs. 18%; p=0.0090) was significantly lower in the pm-Pac-plus-cisplatin group than in the sb-Pac-plus-cisplatin group.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, PR China.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gu', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Thoracic Oncology, Fujian Cancer Hospital, The Affiliated Cancer Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Chemotherapy, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Department of Pneumology, Anhui Provincial Hospital, The First Affiliated Hospital of USTC, Hefei, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Department of Oncology, Jiangsu Province Hospital, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Tianjin Union Medical Centre, Tianjin China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Department of Tumor Chemotherapy, Yunnan Cancer Hospital, The Third Affiliated Hospital of Kunming Medical University, Yunnan Cancer Center, Kunming, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Oncology, Hubei Cancer Hospital, Wuhan, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Shen', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Oncology, Chinese PLA general hospital, Beijing, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Department of Pneumology, Shanghai East Hospital, The Affiliated East Hospital of Tongji University, Shanghai, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tao', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Shantou Central Hospital, Affiliated Shantou Hospital of Sun Yat-Sen University, Shantou, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Oncology, Henan Provincial Chest Hospital, Zhengzhou, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Pneumology, The Affiliated Zhongshan Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Medical Oncology, Puyang Oilfield General Hospital, Puyang, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Medical Oncology, The Affiliated Hospital of Qinghai University, Xining, China.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'School of Public Health, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'School of Public Health, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Yizhong Biotechnical Co., Ltd., Shanghai, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Shanghai Yizhong Biotechnical Co., Ltd., Shanghai, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Shanghai Yizhong Biotechnical Co., Ltd., Shanghai, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Shanghai Yizhong Biotechnical Co., Ltd., Shanghai, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China. Electronic address: hanxkyy@aliyun.com.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, Guangzhou, China. Electronic address: syylwu@live.cn.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.10.479']
1619,33130235,Effect of Intensive Urate Lowering With Combined Verinurad and Febuxostat on Albuminuria in Patients With Type 2 Diabetes: A Randomized Trial.,"RATIONALE & OBJECTIVE
Hyperuricemia has been implicated in the development and progression of chronic kidney disease (CKD). Verinurad is a novel, potent, specific urate reabsorption inhibitor. We evaluated the effects of intensive urate-lowering therapy with verinurad combined with the xanthine oxidase (XO) inhibitor febuxostat on albuminuria in patients with hyperuricemia and type 2 diabetes mellitus (T2DM).
STUDY DESIGN
Phase 2, multicenter, prospective, randomized, double-blind, parallel-group, placebo-controlled trial.
SETTING & PARTICIPANTS
Patients aged ≥18 years with hyperuricemia, albuminuria, and T2DM.
INTERVENTION
Patients randomized 1:1 to verinurad (9 mg) and febuxostat (80 mg) or matched placebo once daily for 24 weeks.
OUTCOMES
The primary endpoint was change in urine albumin-to-creatinine ratio (UACR) from baseline after 12 weeks' treatment. Secondary endpoints included safety and tolerability, and effect on kidney function.
RESULTS
In total, 60 patients were enrolled (n=32, verinurad and febuxostat; n=28, placebo). UACRs after treatment with verinurad and febuxostat were lower than after placebo at 1, 12, and 24 weeks: -38.6% (90% CI -60.9, -3.6), -39.4% (90% CI -61.8, -3.8) and -49.3% (90% CI -68.2, -19.0), respectively. Serum urate (sUA) levels after treatment with verinurad and febuxostat were 59.6% and 63.7% lower than after placebo at 12 and 24 weeks, respectively. No clinically meaningful changes were observed in estimated glomerular filtration rates (eGFR), serum creatinine, or serum cystatin C concentrations. Verinurad and febuxostat were well tolerated.
LIMITATIONS
Sample size and study duration were insufficient to evaluate definitive effects of verinurad and febuxostat on UACR and kidney function. Generalizability was limited by exclusion of patients with stage 4 and 5 CKD.
CONCLUSIONS
Verinurad and febuxostat reduced albuminuria and lowered sUA concentrations in patients with T2DM, albuminuria, and hyperuricemia. Definitive assessment of their combined impact on preservation of kidney function awaits larger clinical studies.",2020,"No clinically meaningful changes were observed in estimated glomerular filtration rates (eGFR), serum creatinine, or serum cystatin C concentrations.","['60 patients were enrolled (n=32, verinurad and febuxostat; n=28', 'patients with T2DM, albuminuria, and hyperuricemia', 'Patients With Type 2 Diabetes', 'Patients aged ≥18 years with hyperuricemia, albuminuria, and T2DM', 'patients with hyperuricemia and type 2 diabetes mellitus (T2DM']","['febuxostat (80 mg) or matched placebo', 'placebo', 'Intensive Urate Lowering With Combined Verinurad and Febuxostat', 'intensive urate-lowering therapy with verinurad combined with the xanthine oxidase (XO) inhibitor febuxostat']","['Serum urate (sUA) levels', 'UACRs', 'safety and tolerability, and effect on kidney function', 'albuminuria and lowered sUA concentrations', 'tolerated', 'glomerular filtration rates (eGFR), serum creatinine, or serum cystatin C concentrations', 'change in urine albumin-to-creatinine ratio (UACR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4519235', 'cui_str': 'verinurad'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C4519235', 'cui_str': 'verinurad'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0043317', 'cui_str': 'Xanthine oxidase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",60.0,0.331098,"No clinically meaningful changes were observed in estimated glomerular filtration rates (eGFR), serum creatinine, or serum cystatin C concentrations.","[{'ForeName': 'Austin G', 'Initials': 'AG', 'LastName': 'Stack', 'Affiliation': 'Department of Nephrology, University Hospital Limerick & Health Research Institute, University of Limerick, Limerick, Ireland. Electronic address: Austin.Stack@ul.ie.'}, {'ForeName': 'Nalina', 'Initials': 'N', 'LastName': 'Dronamraju', 'Affiliation': 'AstraZeneca R&D, Gaithersburg, MD, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Parkinson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Johansson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Johnsson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Erlandsson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Terkeltaub', 'Affiliation': 'VAHCS and University of California, San Diego, CA, USA.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2020.09.009']
1620,33130236,Oncology patients were found to understand and accept the Trials Within Cohorts design.,"PURPOSE
The Trials-Within-Cohorts (TwiCs) design aims to reduce recruitment difficulties and disappointment bias in pragmatic trials. Upon cohort enrollment, broad informed consent for randomization is asked, after which cohort-participants can be randomized to interventions or serve as controls without further notification. We evaluated patients' recollection, understanding and acceptance of broad consent in a clinical oncology setting.
METHODS
We surveyed 610 patients with cancer participating in ongoing TwiCs cohorts; 482 patients responded (79%), of which 312 patients shortly after cohort enrollment, 108 patients after randomization to an intervention (12-18 months after cohort enrollment), and a random sample of 62 cohort-participants who had not been selected for interventions (1-6 months after cohort enrollment).
RESULTS
Shortly after providing cohort consent, 76% (n=238/312) adequately remembered whether they had given broad consent for randomization. Of patients randomly offered interventions, 76% (n=82/108) remembered giving broad consent for randomization; 41% (n=44/108) understood they were randomly selected, 44% (n=48/108) were not interested in selection procedures and 10% (n=11/108) did not understand selection was random. Among patients not selected for interventions, 42% (n=26/62) understood selection was random; 89% felt neutral regarding the scenario of ""not being selected for an intervention while your data were being used in comparison with patients receiving interventions"", 10% felt reassured (n=6/62) and 2% scared/insecure (n=2/62).
CONCLUSION
Patients adequately remember giving broad consent for randomization shortly after cohort enrollment and after being offered an intervention, but recollection is lower in those never selected for interventions. Patients are acceptant of serving as control without further notifications.",2020,"Of patients randomly offered interventions, 76% (n=82/108) remembered giving broad consent for randomization; 41% (n=44/108) understood they were randomly selected, 44% (n=48/108) were not interested in selection procedures and 10% (n=11/108) did not understand selection was random.","['610 patients with cancer participating in ongoing TwiCs cohorts; 482 patients responded (79%), of which 312 patients shortly after cohort enrollment, 108 patients after randomization to an intervention (12-18 months after cohort enrollment), and a random sample of 62 cohort-participants who had not been selected for interventions (1-6 months after cohort enrollment']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",[],[],610.0,0.130457,"Of patients randomly offered interventions, 76% (n=82/108) remembered giving broad consent for randomization; 41% (n=44/108) understood they were randomly selected, 44% (n=48/108) were not interested in selection procedures and 10% (n=11/108) did not understand selection was random.","[{'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Young-Afat', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, The Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. Electronic address: d.a.youngafat@umcutrecht.nl.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gal', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Gerlich', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Burbach', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'van der Velden', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'van den Bongard', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Intven', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kasperts', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'van der Graaf', 'Affiliation': 'Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'van Gils', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands; Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Verkooijen', 'Affiliation': 'Imaging Division, University Medical Center Utrecht, Utrecht, The Netherlands; Utrecht University, Utrecht, The Netherlands.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.10.015']
1621,33130252,Original Study Submission to Brain Stimulation Prefrontal Transcranial Direct-Current Stimulation Improves Early Technical Skills in Surgery.,"BACKGROUND
Studies applying transcranial direct-current stimulation (tDCS) to motor regions to enhance surgical skills have observed modest benefits in performance. Early surgical skills acquisition is known to be dependent on the prefrontal cortex (PFC) which could be a suitable target for performance enhancement in fields with high cognitive demand.
OBJECTIVE
To assess whether prefrontal tDCS could improve early phases of surgical skill development.
METHODS
In a randomized sham-controlled double-blind parallel design, 40 surgical novices performed an open knot-tying task repeated in three blocks; pre-, online- and post-tDCS. During online stimulation, participants were randomized to either active tDCS (2mA for 15 min) to the prefrontal cortex (anode over F3, cathode over F4) or sham tDCS. Performance score (PS) was computed using a validated algorithm and introspective workload domains were assessed using a SURG-TLX questionnaire.
RESULTS
There was no difference in demographics or PS between groups prior to receiving tDCS. PS significantly improved from pre-to online- (p < 0.001) and from pre-to post-tDCS (p < 0.001) in the active group only. Following active tDCS, PS was closer to the defined proficiency benchmark and significantly greater compared to sham (p = 0.002). Only the active group reported significantly improved temporal demand scores from pre-to online- (p = 0.004) to post-tDCS (p = 0.002).
CONCLUSIONS
This study demonstrates significantly improved early phase surgical-skill acquisition following prefrontal tDCS. Further work is required to determine the underlying neurophysiological mechanisms and whether the benefits observed are retained long-term.",2020,"Only the active group reported significantly improved temporal demand scores from pre-to online- (p = 0.004) to post-tDCS (p = 0.002).
","['40 surgical novices', 'Surgery']","['prefrontal tDCS', 'transcranial direct-current stimulation (tDCS', 'Brain Stimulation Prefrontal Transcranial Direct-Current Stimulation', 'active tDCS (2mA for 15 min) to the prefrontal cortex (anode over F3, cathode over F4) or sham tDCS']","['demographics or PS', 'Performance score (PS', 'temporal demand scores', 'PS']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0003103', 'cui_str': 'Anode'}, {'cui': 'C0007441', 'cui_str': 'Cathode'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}]",40.0,0.251524,"Only the active group reported significantly improved temporal demand scores from pre-to online- (p = 0.004) to post-tDCS (p = 0.002).
","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ashcroft', 'Affiliation': ""Department of Surgery & Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor, QEQM Building, Praed Street, London, W2 1NY.""}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': ""Department of Surgery & Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor, QEQM Building, Praed Street, London, W2 1NY. Electronic address: ronak.patel@imperial.ac.uk.""}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Woods', 'Affiliation': 'Department of Clinical and Health Psychology, Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery & Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor, QEQM Building, Praed Street, London, W2 1NY.""}, {'ForeName': 'Harsimrat', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': ""Department of Surgery & Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor, QEQM Building, Praed Street, London, W2 1NY.""}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Leff', 'Affiliation': ""Department of Surgery & Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor, QEQM Building, Praed Street, London, W2 1NY.""}]",Brain stimulation,['10.1016/j.brs.2020.10.013']
1622,33131328,"Addition of aerobic training to conventional rehabilitation after hip fracture: a randomized, controlled, pilot feasibility study.","OBJECTIVES
To determine the feasibility and safety of aerobic training with an arm crank ergometer and its effectiveness in improving functional capacity and gait in patients with recent hip fracture.
DESIGN
Randomized, controlled, assessor-blinded pilot study, with intention-to-treat analysis.
SETTING
Inpatients, rehabilitation department.
SUBJECTS
40 patients with hip fracture surgically treated.
INTERVENTIONS
Training group performed aerobic exercise with an arm crank ergometer (15 sessions, 30 minutes/day) at an intensity of 64% to 76% of maximum heart rate, in addition to conventional inpatient rehabilitation.
MAIN MEASURES
Primary outcome was the feasibility (including eligibility rate, recruitment rate, number of drop-outs and adverse events, adherence). Secondary measures were the Timed Up and Go test, ability to walk independently, muscle torque of knee extensors of fractured and non-fractured leg, Functional Independence Measure.
RESULTS
Mostly due to pre-existing disability and fracture type, only 40/301 (13%) patients were eligible (age 84.6 ± 7.6 years, 75% female); all agreed to participate and 90% completed the trial, without adverse events. Adherence to aerobic exercise was good, with high attendance at sessions (93%), a strong compliance to exercise duration (95%) but lower compliance to the prescribed intensity (73%). After the program, more patients were able to walk independently in the training group ( n = 18) compared to control ( n = 13) ( P < 0.05). Also the muscle torque of fractured leg knee extensors was higher in the training group ( P < 0.05).
CONCLUSION
Aerobic training in addition to conventional rehabilitation after a hip fracture is feasible and safe and it was effective in improving gait performance and strength of fractured leg.
TRIAL REGISTRATION
NCT04025866.",2020,"Aerobic training in addition to conventional rehabilitation after a hip fracture is feasible and safe and it was effective in improving gait performance and strength of fractured leg.
","['Inpatients, rehabilitation department', '40 patients with hip fracture surgically treated', 'patients with recent hip fracture', 'after hip fracture', 'patients were eligible (age 84.6\u2009±\u20097.6\u2009years, 75% female); all agreed to participate and 90% completed the trial, without adverse events']","['aerobic training with an arm crank ergometer', 'conventional rehabilitation', 'aerobic training', 'aerobic exercise', 'Training group performed aerobic exercise with an arm crank ergometer', 'Aerobic training']","['feasibility (including eligibility rate, recruitment rate, number of drop-outs and adverse events, adherence', 'Timed Up and Go test, ability to walk independently, muscle torque of knee extensors of fractured and non-fractured leg, Functional Independence Measure', 'gait performance and strength of fractured leg', 'functional capacity and gait', 'muscle torque of fractured leg knee extensors']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0587478', 'cui_str': 'Rehabilitation department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C1542178', 'cui_str': 'Fracture of lower leg'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",40.0,0.061292,"Aerobic training in addition to conventional rehabilitation after a hip fracture is feasible and safe and it was effective in improving gait performance and strength of fractured leg.
","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Corna', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Istituti Clinici Scientifici Maugeri, Institute of Veruno, IRCCS, Gattico-Veruno, NO, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Arcolin', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Istituti Clinici Scientifici Maugeri, Institute of Veruno, IRCCS, Gattico-Veruno, NO, Italy.'}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Giardini', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Istituti Clinici Scientifici Maugeri, Institute of Veruno, IRCCS, Gattico-Veruno, NO, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Bellotti', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Istituti Clinici Scientifici Maugeri, Institute of Veruno, IRCCS, Gattico-Veruno, NO, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Godi', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Istituti Clinici Scientifici Maugeri, Institute of Veruno, IRCCS, Gattico-Veruno, NO, Italy.'}]",Clinical rehabilitation,['10.1177/0269215520968694']
1623,33131393,Do the Number of Visits and the Cost of Musculoskeletal Care Improve Outcomes? More May Not Be Better.,"OBJECTIVES
To determine the relationship between health care use and the magnitude of change in patient-reported outcomes in individuals who received treatment for subacromial pain syndrome. The secondary objective was to determine the value of care, as measured by change in pain and disability per dollar spent.
DESIGN
Secondary analysis of a randomized clinical trial that investigated the effects of nonsurgical care for subacromial pain syndrome.
METHODS
Two groups of treatment responders were created, based on 1-year change in Shoulder Pain and Disability Index (SPADI) score (high, 46.83 points; low, 8.21 points). Regression analysis was performed to determine the association between health care use and 1-year change in SPADI score. Baseline SPADI score was used as a covariate in the regression analysis. Value was measured by comparing health care visits and costs expended per SPADI 1-point change between responder groups.
RESULTS
Ninety-eight patients were included; 38 were classified as high responders (mean 1-year SPADI change score, 46.83 points) and 60 were classified as low responders (1-year SPADI change score, 8.21 points). Neither unadjusted medical visits (5.89; 95% confidence interval [CI]: 4.35, 7.44 versus 6.30; 95% CI: 5.14, 7.46) nor medical costs ($1404.86; 95% CI: $1109.34, $1779.09 versus $1679.26; 95% CI: $1391.54, $2026.48) were significantly different between high and low responders, respectively.
CONCLUSION
Neither the number of visits nor the financial cost of nonsurgical shoulder- related care was associated with improvement in shoulder pain and disability at 1 year. J Orthop Sports Phys Ther 2020;50(11):642-648. doi:10.2519/jospt.2020.9440 .",2020,Neither the number of visits nor the financial cost of nonsurgical shoulder- related care was associated with improvement in shoulder pain and disability at 1 year. ,['individuals who received treatment for subacromial pain syndrome'],['nonsurgical care'],"['shoulder pain and disability', 'health care use and 1-year change in SPADI score', 'medical costs', 'unadjusted medical visits', 'health care visits and costs expended per SPADI 1-point change', 'Shoulder Pain and Disability Index (SPADI) score', 'pain and disability per dollar spent', 'Baseline SPADI score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4728045', 'cui_str': 'Subacromial pain syndrome'}]",[],"[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0562019', 'cui_str': 'dollar'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",98.0,0.22955,Neither the number of visits nor the financial cost of nonsurgical shoulder- related care was associated with improvement in shoulder pain and disability at 1 year. ,"[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Clewley', 'Affiliation': ''}, {'ForeName': 'Yusra', 'Initials': 'Y', 'LastName': 'Iftikhar', 'Affiliation': ''}, {'ForeName': 'Maggie E', 'Initials': 'ME', 'LastName': 'Horn', 'Affiliation': ''}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Rhon', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2020.9440']
1624,33131458,"Can more people be ""Happy Being Me""? Testing the delivery of a universal body satisfaction program by clinicians and school staff.","The research presented here evaluates the delivery of Happy Being Me (HBM; Dunstan, Paxton & McLean, 2017) with boys and girls in their first year of secondary school in the UK (Year 7 and after comparisons aged 11-12). HBM is a manualised universal prevention programme which aims to improve body dissatisfaction and associated risk factors. Risk factors studied here were internalization of the thin ideal, physical appearance comparisons, appearance conversations. Secondary outcomes measured were self-esteem and eating disorder symptoms Study 1 tested the effectiveness of HBM (n = 172) compared to a control group (n = 197) who received curriculum as usual. HBM resulted in significantly improved body satisfaction post-intervention which was maintained at follow up. There were no significant changes in risk factors. Study 2 compared clinician (n = 172) and teacher (n = 174) delivery. Students who received clinician-led, but not teacher-led, HBM had improved body satisfaction and this was maintained at follow up. Internalization of the thin ideal and self-esteem, improved in both clinician and teacher-led groups with small to medium sized effects. HBM can be delivered by clinicians independent of programme developers in a heterogeneous sample with positive effects on body satisfaction. Issues arising for wider delivery are discussed.",2020,"Students who received clinician-led, but not teacher-led, HBM had improved body satisfaction and this was maintained at follow up.",['2017) with boys and girls in their first year of secondary school in the UK (Year 7 and after comparisons aged 11-12'],['HBM'],"['body satisfaction', 'risk factors', 'self-esteem and eating disorder symptoms Study 1 tested the effectiveness of HBM']","[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0018592', 'cui_str': 'Cheerful mood'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}]",,0.0338779,"Students who received clinician-led, but not teacher-led, HBM had improved body satisfaction and this was maintained at follow up.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'Maudsley Centre for Child and Adolescent Eating Disorders, South London and Maudsley NHS Foundation Trust , London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Goddard', 'Affiliation': 'Maudsley Centre for Child and Adolescent Eating Disorders, South London and Maudsley NHS Foundation Trust , London, UK.'}, {'ForeName': 'Ziba', 'Initials': 'Z', 'LastName': 'Cakir', 'Affiliation': 'Maudsley Centre for Child and Adolescent Eating Disorders, South London and Maudsley NHS Foundation Trust , London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hall', 'Affiliation': 'Maudsley Centre for Child and Adolescent Eating Disorders, South London and Maudsley NHS Foundation Trust , London, UK.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Allen', 'Affiliation': 'Maudsley Centre for Child and Adolescent Eating Disorders, South London and Maudsley NHS Foundation Trust , London, UK.'}]",Eating disorders,['10.1080/10640266.2020.1771165']
1625,33131460,Influence of countermovement depth on the countermovement jump-derived reactive strength index modified.,"This study aimed to investigate the effect of countermovement depth on the magnitude of the countermovement jump (CMJ) derived reactive strength index modified (RSI mod ), and to compare the RSI mod between the CMJ performed with a self-preferred knee flexion angle (CMJ pref ) and the CMJ performed from a pre-determined knee flexion angle (CMJ refer ) with the countermovement depth more similar to the CMJ pref . Sixteen subjects (11 males and 5 females; age 25.1±6.3 years, body mass 69.7±10.2 kg, body height 172.9±8.1 m) randomly performed in a single session the CMJ pref and CMJs from five pre-determined knee flexion angles (60°, 75°, 90°, 105°, and 120°). Our results showed that lower knee flexion angles were generally associated with greater RSI mod values with the CMJ performed at 60° showing the greatest RSI mod ( P ≤0.049; effect size [ES] range=0.19-0.63). The greatest RSI mod for the CMJ performed at 60° was caused by the proportionally lower values of the time to take-off (ES range=0.65-1.91) compared to the decrease observed in jump height (ES range=0.11-0.25). The RSI mod was higher for the CMJ pref compared to the CMJ refer ( P <0.001; ES=0.34) due to a higher jump height ( P =0.021; ES=0.14) and reduced time to take-off ( P <0.001; ES=0.85). These results indicate that practitioners should be careful when interpreting an individual's changes in RSI mod when the countermovement depth is not similar across the testing sessions. However, since the use of pre-determined knee flexion angles negatively impacts the RSI mod , we encourage practitioners to use the CMJ pref but only compare the RSI mod when CMJs are performed using consistent countermovement depths.",2020,The RSI mod was higher for the CMJ pref compared to the CMJ refer ( P <0.001; ES=0.34) due to a higher jump height ( P =0.021; ES=0.14) and reduced time to take-off ( P <0.001; ES=0.85).,"['Sixteen subjects (11 males and 5 females; age 25.1±6.3 years, body mass 69.7±10.2 kg, body height 172.9±8.1 m']",[],"['RSI mod', 'knee flexion angles']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",[],"[{'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",,0.0179744,The RSI mod was higher for the CMJ pref compared to the CMJ refer ( P <0.001; ES=0.34) due to a higher jump height ( P =0.021; ES=0.14) and reduced time to take-off ( P <0.001; ES=0.85).,"[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Pérez-Castilla', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Weakley', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Campus University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'García-Pinillos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'Rojas', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}]",European journal of sport science,['10.1080/17461391.2020.1845815']
1626,33131470,[Proactive anti-inflammatory and anticoagulant therapy in the treatment of advanced stages of novel coronavirus infection (COVID-19). Case Series and Study Design: COLchicine versus ruxolitinib and secukinumab in open prospective randomIzed trial (COLORIT)].,"The article is devoted to the treatment of the new coronavirus infection (COVID-19) in the advanced stages of the disease. The types of response of the immune system to the viral load of SARS-CoV-2 with the start of the inflammation process are considered. The situation is analyzed in detail in which the growing autoimmune inflammation (up to the development of a ""cytokine storm"") affects not only the pulmonary parenchyma, but also the endothelium of the small vessels of the lungs. Simultaneous damage to the alveoli and microthrombosis of the pulmonary vessels are accompanied by a progressive impairment of gas exchange, the development of acute respiratory distress syndrome, the treatment of which, even with the use of invasive ventilation, is ineffective and does not really change the prognosis of patients with COVID-19. In order to interrupt the pathological process at the earliest stages of the disease, the necessity of proactive anti-inflammatory therapy in combination with active anticoagulation treatment is substantiated. The results of the first randomized studies on the use of inhibitors of pro-inflammatory cytokines and chemokines (interleukin-6 (tocilizumab), interleukin-17 (secukinumab), Janus kinase blockers, through which the signal is transmitted to cells (ruxolitinib)), which have potential in the early treatment of COVID- 19. The use of a well-known anti-inflammatory drug colchicine (which is used for gout treatment) in patients with COVID-19 is considered. The design of the original COLORIT comparative study on the use of colchicine, ruxolitinib and secukinumab in the treatment of COVID-19 is presented. Clinical series presented, illustrated early anti-inflammatory therapy together with anticoagulants in patients with COVID-19 and the dangers associated with refusing to initiate such therapy on time.",2020,The article is devoted to the treatment of the new coronavirus infection (COVID-19) in the advanced stages of the disease.,['advanced stages of novel coronavirus infection (COVID-19'],"['colchicine, ruxolitinib and secukinumab', 'inhibitors of pro-inflammatory cytokines and chemokines (interleukin-6 (tocilizumab), interleukin-17 (secukinumab), Janus kinase blockers', 'Proactive anti-inflammatory and anticoagulant therapy', 'COLchicine versus ruxolitinib and secukinumab', 'colchicine']",[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy'}]",[],,0.0223531,The article is devoted to the treatment of the new coronavirus infection (COVID-19) in the advanced stages of the disease.,"[{'ForeName': 'V Yu', 'Initials': 'VY', 'LastName': 'Mareev', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia Faculty of Fundamental Medicine, Lomonosov Moscow State University, Russia.'}, {'ForeName': 'Ya A', 'Initials': 'YA', 'LastName': 'Orlova', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia Faculty of Fundamental Medicine, Lomonosov Moscow State University, Russia.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Pavlikova', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia Faculty of Fundamental Medicine, Lomonosov Moscow State University, Russia.'}, {'ForeName': 'Z A', 'Initials': 'ZA', 'LastName': 'Akopyan', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia Faculty of Fundamental Medicine, Lomonosov Moscow State University, Russia.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Matskeplishvili', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Plisyk', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia Faculty of Fundamental Medicine, Lomonosov Moscow State University, Russia.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Seredenina', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia Faculty of Fundamental Medicine, Lomonosov Moscow State University, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Potapenko', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia Faculty of Fundamental Medicine, Lomonosov Moscow State University, Russia.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Malakhov', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Samokhodskaya', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia Faculty of Fundamental Medicine, Lomonosov Moscow State University, Russia.'}, {'ForeName': 'Е А', 'Initials': 'ЕА', 'LastName': 'Mershina', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia Faculty of Fundamental Medicine, Lomonosov Moscow State University, Russia.'}, {'ForeName': 'V E', 'Initials': 'VE', 'LastName': 'Sinitsyn', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia Faculty of Fundamental Medicine, Lomonosov Moscow State University, Russia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Asratyan', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Zhdanova', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia Faculty of Fundamental Medicine, Lomonosov Moscow State University, Russia.'}, {'ForeName': 'Yu V', 'Initials': 'YV', 'LastName': 'Mareev', 'Affiliation': 'National Medical Research Centre for Therapy and Preventive Medicine, Moscow, Russia Robertson Centre for Biostatistics, Glasgow, Great Britain.'}, {'ForeName': 'Yu L', 'Initials': 'YL', 'LastName': 'Begrambekova', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia Faculty of Fundamental Medicine, Lomonosov Moscow State University, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Shatochina', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia.'}, {'ForeName': 'А А', 'Initials': 'АА', 'LastName': 'Kamalov', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia Faculty of Fundamental Medicine, Lomonosov Moscow State University, Russia.'}]",Kardiologiia,['10.18087/cardio.2020.9.n1338']
1627,33131560,Issues with the conduct and reporting of split-mouth randomized clinical trial.,,2020,,[],[],[],[],[],[],,0.257457,,"[{'ForeName': 'Kunaal', 'Initials': 'K', 'LastName': 'Dhingra', 'Affiliation': 'New Delhi, India.'}, {'ForeName': 'Prabhat Kumar', 'Initials': 'PK', 'LastName': 'Chaudhari', 'Affiliation': 'New Delhi, India.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'New Delhi, India.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2020.07.025']
1628,33131597,Evaluation of vitamin D plasma levels after mild exposure to the sun with photoprotection.,"Background Most of the organism's vitamin D (VD) is obtained through the cutaneous synthesis after exposure to the sun's UVB radiation. Sunscreens are indicated for the prevention of actinic damage to the skin, however, there are few clinical trials assessing the synthesis of cutaneous VD in real-life situations of sun exposure with ordinary clothing and usual photoprotection. Objectives To evaluate the synthesis of VD with suberythemal sun exposure in healthy adults using topical photoprotection (SPF 30).
METHODS
Quasi-experimental study, conducted at Rio de Janeiro (Brazil), during winter, with 95 healthy adults who had 25-OH-VD checked twice, 24 hours apart, and were exposed to the sun (UVB=20 mJ/cm2), according to a randomized grouping: SC - use of SPF 30 on the face, neck and chest (n=64), NO - no sunscreens (n=10), CO - confined from sun exposure for 24h (n=21). The groups were matched according to the propensity score related to gender, age, phototype, body mass index, glycosylated hemoglobin and baseline levels of VD. The outcome evaluated was the variation (ΔVD) in serum level of 25-OH-VD (ng/ml) between the groups.
RESULTS
A statistically significant difference was identified between CO and SC groups [median (p25-p75)]: ΔVD =1.4 (-0.3-3.6) vs. 5.5 (4.8-6.6); p<0.01. There was no difference between SC and NO groups: 5.4 (3.1-6.1) vs. 4.1 (2.5-6.0); p=0.17.
STUDY LIMITATIONS
Laboratory analysis technique (chemiluminescence) with great variability, loss of food intake standardatization, unbalanced groups.
CONCLUSIONS
Suberythemal sun exposure with sunscreen (SPF 30) provides similar vitamin D serum variation than without photoprotection in healthy adults.",2019,A statistically significant difference was identified between CO and SC groups [median (p25-p75)],"['mild exposure to the sun with photoprotection', 'Quasi-experimental study, conducted at Rio de Janeiro (Brazil), during winter, with 95 healthy adults who had 25-OH-VD checked twice, 24 hours apart, and were exposed to the sun (UVB=20 mJ/cm2), according to a randomized grouping: SC - use of SPF 30 on the face, neck and chest (n=64), NO - no sunscreens (n=10), CO - confined from sun exposure for 24h (n=21', 'healthy adults', 'healthy adults using topical photoprotection (SPF 30']","[""organism's vitamin D (VD"", 'Suberythemal sun exposure with sunscreen (SPF 30']","['variation (ΔVD) in serum level of 25-OH-VD', 'vitamin D plasma levels']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0445581', 'cui_str': 'Rio'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0439479', 'cui_str': 'sq. cm'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1522438', 'cui_str': 'Subcutaneous route'}, {'cui': 'C0812425', 'cui_str': 'Mitotic index'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1562459', 'cui_str': 'Neck and chest'}, {'cui': 'C0038818', 'cui_str': 'Sunscreen agent'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0038818', 'cui_str': 'Sunscreen agent'}, {'cui': 'C0812425', 'cui_str': 'Mitotic index'}]","[{'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",95.0,0.0313092,A statistically significant difference was identified between CO and SC groups [median (p25-p75)],"[{'ForeName': 'Luiza Alonso', 'Initials': 'LA', 'LastName': 'Pereira', 'Affiliation': 'Department of Dermatology, Universidade Federal Fluminense, Niterói (RJ), Brasil.'}, {'ForeName': 'Flávio Barbosa', 'Initials': 'FB', 'LastName': 'Luz', 'Affiliation': 'Discipline of Dermatology, Department of Dermatology, Universidade Federal Fluminense, Niterói (RJ), Brasil.'}, {'ForeName': 'Clívia Maria Moraes de Oliveira', 'Initials': 'CMMO', 'LastName': 'Carneiro', 'Affiliation': 'Discipline of Dermatology, Department of Dermatology, Universidade Federal do Pará, Belém (PA), Brasil.'}, {'ForeName': 'Ana Lucia Rampazzo', 'Initials': 'ALR', 'LastName': 'Xavier', 'Affiliation': 'Discipline of Pathology, Department of Pathology-Clinical Biochemistry, Universidade Federal Fluminenese, Niterói (RJ), Brasil.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Kanaan', 'Affiliation': 'Discipline of Pathology, Department of Pathology-Clinical Biochemistry, Universidade Federal Fluminenese, Niterói (RJ), Brasil.'}, {'ForeName': 'Hélio Amante', 'Initials': 'HA', 'LastName': 'Miot', 'Affiliation': 'Discipline of Dermatology, Department of Dermatology and Radiotherapy, Universidade Estadual Paulista, Botucatu (SP), Brasil. Electronic address: heliomiot@gmail.com.'}]",Anais brasileiros de dermatologia,['10.1590/abd1806-4841.20198070']
1629,33131743,The effect of unhealthy food and liking on stress reactivity.,"In many individuals, stress appears to stimulate an increase in energy intake as well as a shift in food choice toward unhealthy food items or ""comfort foods"". Eating during stress is widely assumed to have anxiolytic properties, but there is little empirical support for this. The current two studies examined if either an unhealthy food item or a healthy food item could reduce stress reactivity and extended previous findings by examining whether participant liking contributes to any potential stress reduction. In the first experiment, participants rated baseline anxiety, were assigned to eat no food, carrots, or a candy bar, rated their anxiety a second time, and reported their liking of the assigned condition. The second experiment followed a similar procedure, except participants underwent a stressor before being asked to eat a food item. In addition, physiological measures of stress (salivary cortisol and α-amylase, and cardiovascular measures) were recorded. In both experiments, there was no effect of food on any measure of emotional or physiological stress. In contrast, participants who highly liked their condition exhibited a suppression of anxiety in both experiments and showed enhanced post-stress recovery of α-amylase. The anxiolytic effects of liking were not dependent on whether participants engaged in the healthy, unhealthy, or no food condition, which indicates that the self-perceived liking of a post-stress activity affects stress recovery more than the nutritional value. This has potential implications in how the population thinks about which activities to engage in to stimulate stress recovery.",2020,"The anxiolytic effects of liking were not dependent on whether participants engaged in the healthy, unhealthy, or no food condition, which indicates that the self-perceived liking of a post-stress activity affects stress recovery more than the nutritional value.",[],['unhealthy food and liking'],"['stress (salivary cortisol and α-amylase, and cardiovascular measures', 'suppression of anxiety', 'emotional or physiological stress', 'stress reactivity', 'anxiolytic effects of liking', 'energy intake']",[],"[{'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C3179404', 'cui_str': 'Anti-Anxiety Effects'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",,0.023487,"The anxiolytic effects of liking were not dependent on whether participants engaged in the healthy, unhealthy, or no food condition, which indicates that the self-perceived liking of a post-stress activity affects stress recovery more than the nutritional value.","[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'McKay', 'Affiliation': 'Department of Psychology, SUNY Buffalo State, 1300 Elmwood Ave., Buffalo, NY 14222, USA. Electronic address: mckaynj@buffalostate.edu.'}, {'ForeName': 'Johnathan', 'Initials': 'J', 'LastName': 'Przybysz', 'Affiliation': 'Department of Psychology, SUNY Buffalo State, 1300 Elmwood Ave., Buffalo, NY 14222, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cavanaugh', 'Affiliation': 'Department of Psychology, SUNY Buffalo State, 1300 Elmwood Ave., Buffalo, NY 14222, USA.'}, {'ForeName': 'Emmitt', 'Initials': 'E', 'LastName': 'Horvatits', 'Affiliation': 'Department of Psychology, SUNY Buffalo State, 1300 Elmwood Ave., Buffalo, NY 14222, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Giorgianni', 'Affiliation': 'Department of Psychology, SUNY Buffalo State, 1300 Elmwood Ave., Buffalo, NY 14222, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Czajka', 'Affiliation': 'Department of Psychology, SUNY Buffalo State, 1300 Elmwood Ave., Buffalo, NY 14222, USA.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113216']
1630,33131786,Immediate effects of cervical mobilisations on neck muscle activity during active neck movements in patients with non-specific neck pain. A double blind placebo controlled trial.,"BACKGROUND
Cervical mobilisations are used to treat people with neck pain but their mechanisms of action are unclear. One theorised reason for induced analgesia is effect on neck muscle activity.
OBJECTIVES
To assess the effects of cervical mobilisations on muscle activity during active neck movements and whether changes in muscle activity are associated with changes in symptoms.
DESIGN
Double-blind randomised placebo controlled trial.
SETTING
Primary care.
PARTICIPANTS
40 patients (aged 19 to 80 years, 24 female) with non-specific neck pain.
INTERVENTIONS
One session of cervical mobilisations or motionless manual contact (placebo).
MAIN OUTCOME MEASURES
sternocleidomastoid (SCM), scalene (SCA), upper trapezius (UT) and erector spinae (ES) surface electromyography (SEMG) during active neck flexion, extension, side flexion and rotation was measured immediately before and after the intervention. Patients were classified as responders according to change in symptoms assessed using the Global Rating of Change Scale (GROC).
RESULTS
Compared with placebo, patients receiving mobilisation showed an increase in contralateral UT and ES SEMG during rotation and contralateral and ipsilateral SCM, SCA and UT during side flexion (P<0.05), however changes were mostly associated with an increase in range and speed of movement. The only association with GROC was increased (5%) SEMG in the contralateral SCM during side flexion in the mobilisation group (P=0.013).
CONCLUSION
Cervical mobilisations caused increased neck SEMG, mostly due to increased movement range and speed. Change in muscle activity is unlikely to be a major mechanism of action of cervical mobilisations in symptomatic improvement with physiological neck movements. (ClinicalTrials.gov record number: 2016/066).
CLINICAL TRIALS REGISTRY
ClinicalTrials.gov record number: 2016/066.",2019,"SEMG in the contralateral SCM during side flexion in the mobilisation group (P=0.013).
","['patients with non-specific neck pain', '40 patients (aged 19 to 80 years, 24 female) with non-specific neck pain']","['cervical mobilisations', 'placebo', 'cervical mobilisations or motionless manual contact (placebo']","['neck muscle activity', 'neck SEMG', 'Global Rating of Change Scale (GROC', 'contralateral UT and ES SEMG during rotation and contralateral and ipsilateral SCM, SCA and UT during side flexion', 'GROC', 'range and speed of movement', 'sternocleidomastoid (SCM), scalene (SCA), upper trapezius (UT) and erector spinae (ES) surface electromyography (SEMG) during active neck flexion, extension, side flexion and rotation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0445088', 'cui_str': 'Neck flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",,0.625859,"SEMG in the contralateral SCM during side flexion in the mobilisation group (P=0.013).
","[{'ForeName': 'Ion', 'Initials': 'I', 'LastName': 'Lascurain-Aguirrebeña', 'Affiliation': ""Division of Health and Social Care Research, Faculty of Life Sciences & Medicine, King's College London, London SE1 1UL, United Kingdom; Department of Physiology, Faculty of Medicine & Nursing, University of the Basque Country UPV/EHU, Leioa 48940, Spain. Electronic address: ion.lascurain@ehu.eus.""}, {'ForeName': 'Di J', 'Initials': 'DJ', 'LastName': 'Newham', 'Affiliation': ""Centre of Human & Applied Physiological Sciences, Faculty of Life Sciences & Medicine, King's College London, London SE1 1UL, United Kingdom. Electronic address: di.newham@kcl.ac.uk.""}, {'ForeName': 'Xabat', 'Initials': 'X', 'LastName': 'Casado-Zumeta', 'Affiliation': 'Atlas Fisioterapia, Donostia-San Sebastian, 20008, Spain. Electronic address: xabatcasado@gmail.com.'}, {'ForeName': 'Aitana', 'Initials': 'A', 'LastName': 'Lertxundi', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of the Basque Country UPV/EHU, Leioa 48940, Spain; Health Research Institute, Biodonostia, San Sebastian, Spain; Spanish Consortium for Research on Epidemiology and Public Health (CIBERESP), Barcelona, Spain. Electronic address: aitana.lertxundi@ehu.eus.'}, {'ForeName': 'Duncan J', 'Initials': 'DJ', 'LastName': 'Critchley', 'Affiliation': ""Division of Health and Social Care Research, Faculty of Life Sciences & Medicine, King's College London, London SE1 1UL, United Kingdom. Electronic address: duncan.critchley@kcl.ac.uk.""}]",Physiotherapy,['10.1016/j.physio.2019.07.003']
1631,33131968,"Activation level as a mediator between behavioral activation, sex, and depression among treatment-seeking smokers.","INTRODUCTION
Behavioral activation (BA) has gained interest when combined with tobacco interventions as it relates to improved depression and cessation rates. However, no prior efforts have examined mediators of BA effectiveness and sex-dependent effects. This secondary analysis assesses the main and interactive effects of sex and type of smoking cessation intervention [a cognitive behavioral treatment (CBT) only, or CBT + BA] on depressive symptoms among treatment-seeking patients with depression. It also examines the activation level as a mediator between BA, BA by sex, and depression.
METHOD
120 smokers were assigned to an 8-week CBT or to CBT + BA. They completed the Beck Depression Inventory-II (BDI-II) and the Behavioral Activation for Depression scale-short-form (BADS-SF). A two-way ANOVA assessed the effects of sex and treatment condition on participants' BDI-II scores. A moderated mediational analysis tested whether the indirect effect of treatment condition on BDI-II through BADS-SF differed by sex.
RESULTS
After controlling for end-of-treatment smoking status and baseline BDI-II, there were no significant effects of treatment condition, sex, and their interaction on end-of-treatment BDI-II. Being a male was indirectly associated with higher BDI-II scores through lower BADS-SF score (point estimate = -3.440; SE = 1.637; BC 95% CI [-7.105, -0.749]). This effect was not found for women.
CONCLUSIONS
There is a need to tailor interventions by sex when treating smokers with depression. It is recommended to assess symptoms such as mental rumination or self-consciousness, which tend to be more pronounced in women.",2020,"Being a male was indirectly associated with higher BDI-II scores through lower BADS-SF score (point estimate = -3.440; SE = 1.637; BC 95% CI [-7.105, -0.749]).","['120 smokers', 'treatment-seeking patients with depression']","['CBT or to CBT\u202f+\u202fBA', 'CBT\u202f+\u202fBA', 'smoking cessation intervention [a cognitive behavioral treatment (CBT']","[""participants' BDI-II scores"", 'Beck Depression Inventory-II (BDI-II) and the Behavioral Activation for Depression scale-short-form (BADS-SF', 'higher BDI-II scores through lower BADS-SF score', 'depressive symptoms', 'BDI-II through BADS-SF']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4273555', 'cui_str': 'Beck Depression Inventory II score'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",120.0,0.0208955,"Being a male was indirectly associated with higher BDI-II scores through lower BADS-SF score (point estimate = -3.440; SE = 1.637; BC 95% CI [-7.105, -0.749]).","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Weidberg', 'Affiliation': 'Department of Psychology, University of Oviedo, Plaza Feijóo s/n, 33003 Oviedo, Spain. Electronic address: weidbergsara.uo@uniovi.es.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'González-Roz', 'Affiliation': 'Department of Psychology, University of Oviedo, Plaza Feijóo s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'García-Fernández', 'Affiliation': 'Department of Psychology, University of Oviedo, Plaza Feijóo s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Secades-Villa', 'Affiliation': 'Department of Psychology, University of Oviedo, Plaza Feijóo s/n, 33003 Oviedo, Spain.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106715']
1632,33131984,Changes in peripheral inflammation-related gene expression by postprandial glycemic response in healthy Japanese men.,"OBJECTIVES
Continuous postprandial hyperglycemia is associated with the onset of cardiovascular disease. In recent years, the mRNA expression of inflammation-related genes in peripheral blood leukocytes has been shown to be induced by an increase in blood glucose levels. The aim of this study was to investigate differences in the expression of inflammation-related genes in peripheral blood leukocytes in response to an increase in blood glucose from individuals who consumed two kinds of breakfast meals with different glycemic indexes (GIs).
METHODS
Twenty healthy Japanese men 40 to 70 y of age were given low- or high-GI meals for breakfast for 14 d. Clinical examinations were performed on days 7 and 14. Their blood glucose levels and insulin concentrations were measured from before breakfast ingestion to 120 min after. Additionally, using the blood obtained before and 120 min after breakfast, the mRNA expression levels of inflammation-related genes in peripheral leukocytes were measured.
RESULTS
The blood glucose levels were significantly lower in the low-GI meal intake group at 30, 60, and 120 min after breakfast than in the high-GI meal intake group. The intake of high-GI meals for 6 d led to an increase in the mRNA levels of interleukin-1β, S100A4, and CD18 compared with the period of low-GI meals.
CONCLUSION
The intake of a low-GI breakfast for 1 wk in healthy Japanese men resulted in lower postprandial blood glucose and insulin levels, which were accompanied by a reduced expression of inflammation-related genes in peripheral blood leukocytes.",2020,"The intake of high-GI meals for 6 d led to an increase in the mRNA levels of interleukin-1β, S100A4, and CD18 compared with the period of low-GI meals.
","['individuals who consumed two kinds of breakfast meals with different glycemic indexes (GIs', 'healthy Japanese men', 'Twenty healthy Japanese men 40 to 70 y of age were given']",['low- or high-GI meals for breakfast for 14 d'],"['blood glucose', 'mRNA expression levels of inflammation-related genes in peripheral leukocytes', 'blood glucose levels', 'postprandial blood glucose and insulin levels', 'mRNA levels of interleukin-1β, S100A4, and CD18', 'blood glucose levels and insulin concentrations']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0064830', 'cui_str': 'Lymphocyte antigen CD18'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",20.0,0.0220312,"The intake of high-GI meals for 6 d led to an increase in the mRNA levels of interleukin-1β, S100A4, and CD18 compared with the period of low-GI meals.
","[{'ForeName': 'Kazue', 'Initials': 'K', 'LastName': 'Honma', 'Affiliation': 'Laboratory of Nutritional Physiology, School of Food and Nutritional Sciences/Graduate Division of Nutritional and Environmental Sciences, University of Shizuoka, Shizuoka, Japan.'}, {'ForeName': 'Fangru', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': 'Laboratory of Nutritional Physiology, School of Food and Nutritional Sciences/Graduate Division of Nutritional and Environmental Sciences, University of Shizuoka, Shizuoka, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Tonaka', 'Affiliation': 'Laboratory of Nutritional Physiology, School of Food and Nutritional Sciences/Graduate Division of Nutritional and Environmental Sciences, University of Shizuoka, Shizuoka, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Sabashi', 'Affiliation': 'SBS Shizuoka Health Promotion Center, Shizuoka, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Otsuki', 'Affiliation': 'Laboratory of Food Management, School of Food and Nutritional Sciences/Graduate Division of Nutritional and Environmental Sciences, University of Shizuoka, Shizuoka, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Ichikawa', 'Affiliation': 'Laboratory of Food Management, School of Food and Nutritional Sciences/Graduate Division of Nutritional and Environmental Sciences, University of Shizuoka, Shizuoka, Japan.'}, {'ForeName': 'Toshinao', 'Initials': 'T', 'LastName': 'Goda', 'Affiliation': 'Laboratory of Nutritional Physiology, School of Food and Nutritional Sciences/Graduate Division of Nutritional and Environmental Sciences, University of Shizuoka, Shizuoka, Japan. Electronic address: gouda@u-shizuoka-ken.ac.jp.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.111026']
1633,33131986,Comparison of three different types of splints and templates for maxilla repositioning in bimaxillary orthognathic surgery: a randomized controlled trial.,"The selection and implementation of a plan for maxillary surgery is of the utmost importance in achieving the desired outcome for the patient undergoing two-jaw orthognathic surgery. Some splint-based and splintless methods, accompanied by computer-assisted techniques, are helpful in improving surgical plan implementation. However, randomized controlled trials focused on this procedure are lacking. This study included 61 patients who underwent bimaxillary surgeries. The patients were randomly assigned to a conventional resin occlusal splint (CROS) group, a digital occlusal splint (DOS) group, or a digital templates (DT) group, in a 1:1:1 ratio. The mean linear distance between the planned and actual postoperative positions of eight selected points on the surfaces of the maxillary teeth was selected as the outcome measure. The distance was significantly smaller in the DT group (1.17±0.66mm) when compared to both the CROS group (2.55±0.95mm, P<0.05) and DOS group (2.15±1.12mm, P<0.05). However, the difference between the CROS group and DOS group was not statistically significant. These findings indicate that using digital templates results in the best performance in transferring the surgical plan to the operation environment as compared to the other two types of splints. This suggests that the application of digital templates could provide a reliable treatment option.",2020,"The distance was significantly smaller in the DT group (1.17±0.66mm) when compared to both the CROS group (2.55±0.95mm, P<0.05) and DOS group (2.15±1.12mm, P<0.05).","['patient undergoing two-jaw orthognathic surgery', '61 patients who underwent bimaxillary surgeries', 'bimaxillary orthognathic surgery']","['CROS', 'digital occlusal splint (DOS) group, or a digital templates (DT', 'conventional resin occlusal splint (CROS', 'maxilla repositioning']",['mean linear distance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4317132', 'cui_str': 'Template'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",61.0,0.0450437,"The distance was significantly smaller in the DT group (1.17±0.66mm) when compared to both the CROS group (2.55±0.95mm, P<0.05) and DOS group (2.15±1.12mm, P<0.05).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Orthognathic and TMJ Surgery, State Key Laboratory of Oral Diseases and National Clinical Research Centre for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bi', 'Affiliation': 'Department of Orthognathic and TMJ Surgery, State Key Laboratory of Oral Diseases and National Clinical Research Centre for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Orthodontic Department, State Key Laboratory of Oral Diseases and National Clinical Research Centre for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Orthodontic Department, State Key Laboratory of Oral Diseases and National Clinical Research Centre for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthognathic and TMJ Surgery, State Key Laboratory of Oral Diseases and National Clinical Research Centre for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Department of Plastic and Aesthetic Surgery, Hospital of Stomatology, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Orthognathic and TMJ Surgery, State Key Laboratory of Oral Diseases and National Clinical Research Centre for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Luo', 'Affiliation': 'Department of Orthognathic and TMJ Surgery, State Key Laboratory of Oral Diseases and National Clinical Research Centre for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Department of Orthognathic and TMJ Surgery, State Key Laboratory of Oral Diseases and National Clinical Research Centre for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China. Electronic address: ZSS_1977@163.com.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2020.09.023']
1634,33132018,Testing the Implementation of Function-focused Care in Assisted Living Settings.,"OBJECTIVES
The purpose of this study was to evaluate the Function-Focused Care for Assisted Living Using the Evidence Integration Triangle (FFC-AL-EIT) intervention.
DESIGN
FFC-AL-EIT was a randomized controlled pragmatic trial including 85 sites and 794 residents.
INTERVENTION
FFC-AL-EIT was implemented by a Research Nurse Facilitator working with a facility champion and stakeholder team for 12 months to increase function and physical activity among residents. FFC-AL-EIT included (Step I) Environment and Policy Assessments; (Step II) Education; (Step III) Establishing Resident Function-Focused Care Service Plans; and (Step IV) Mentoring and Motivating.
SETTING AND PARTICIPANTS
The age of participants was 89.48 years [standard deviation (SD) = 7.43], and the majority were female (n = 561; 71%) and white (n = 771; 97%).
METHODS
Resident measures, obtained at baseline, 4, and 12 months, included function, physical activity, and performance of function-focused care. Setting outcomes, obtained at baseline and 12 months, included environment and policy assessments and service plans.
RESULTS
Reach was based on 85 of 90 sites that volunteered (94%) participating. Effectiveness was based on less decline in function (P < .001), more function-focused care (P = .012) and better environment (P = .032) and policy (P = .003) support for function-focused care in treatment sites. Adoption was supported with 10.00 (SD = 2.00) monthly meetings held, 77% of settings engaged in study activities as or more than expected, and direct care workers providing function-focused care (63% to 68% at 4 months and 90% at 12 months). The intervention was implemented as intended, and education was received based on a mean knowledge test score of 88% correct. Evidence of maintenance from 12 to 18 months was noted in treatment site environments (P = .35) and policies continuing to support function-focused care (P = .28)].
CONCLUSIONS AND IMPLICATIONS
The Evidence Integration Triangle is an effective implementation approach for assisted living. Future work should continue to consider innovative approaches for measuring RE-AIM outcomes.",2020,"Effectiveness was based on less decline in function (P < .001), more function-focused care (P = .012) and better environment (P = .032) and policy (P = .003) support for function-focused care in treatment sites.","['85 sites and 794 residents', 'The age of participants was 89.48\xa0years [standard deviation (SD)\xa0= 7.43], and the majority were female (n\xa0= 561; 71%) and white (n\xa0= 771; 97']",[],"['function-focused care', 'included environment and policy assessments and service plans', 'function, physical activity, and performance of function-focused care']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]",[],"[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0494659,"Effectiveness was based on less decline in function (P < .001), more function-focused care (P = .012) and better environment (P = .032) and policy (P = .003) support for function-focused care in treatment sites.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Resnick', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, MD, USA. Electronic address: Resnick@umaryland.edu.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Boltz', 'Affiliation': 'College of Nursing, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Galik', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fix', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Holmes', 'Affiliation': 'Lamy Center, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Barr', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, MD, USA.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.09.026']
1635,33137517,Effects of acupressure and Acupuncture-like TENS on sleep Quality among Pregnant Women.,"BACKGROUND
Despite the adverse consequences of poor sleep during pregnancy, relatively few safe interventions exist for improving sleep among pregnant women. Non pharmacological interventions are increasingly gaining acceptance. However, the effects of acupressure and ACUTENS have not been widely reported.
OBJECTIVES
he purpose of this study is to investigate the effects of low frequency Transcutaneous Electrical Nerve Stimulation (TENS) other wisely known as ACUTENS and Acupressure on sleep quality among pregnant women.
METHODS
Purposive sampling of 42 pregnant women with sleep disorders were randomized into 3 groups, i.e. acupressure, ACUTENS and Usual Care. Interventions were carried out twice weekly for six weeks. Pittsburg Sleep Quality index (PSQI) was used to determine the overall sleep quality.
RESULTS
pre-intervention scores sleep quality recorded were 12.5 (3.75), 12.5(4.0), and 13.0(3.5) by the ACUTENS, Acupressure and Usual care groups respectively. Krauskal-Wallis test did not show any significant difference in the pre-intervention sleep quality scores (H=0.379 P=0.827). Participants in the usual care recorded the least improvement with a score of 5.0(2.2.5, the ACUTENS group recorded 4.5(3.0) and the greatest improvement was recorded by the Acupressure group with a score of 4.0(2.2) after 6 weeks of intervention. Krauskal-Wallis test did not show any significant difference in the post-intervention sleep quality scores among the 3 groups (H=0.666 P=0.717).
CONCLUSION
This study showed that ACUTENS, acupressure as an adjunct to usual care are not more effective than usual care alone in improving sleep quality among pregnant women.",2020,Krauskal-Wallis test did not show any significant difference in the pre-intervention sleep quality scores (H=0.379 P=0.827).,"['pregnant women', '42 pregnant women with sleep disorders', 'Pregnant Women']","['low frequency Transcutaneous Electrical Nerve Stimulation (TENS', 'acupressure and Acupuncture-like TENS', 'acupressure', 'Acupressure']","['sleep Quality', 'pre-intervention sleep quality scores', 'post-intervention sleep quality scores', 'scores sleep quality', 'Pittsburg Sleep Quality index (PSQI', 'overall sleep quality', 'sleep quality']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0394677', 'cui_str': 'Acupuncture-like transcutaneous electrical nerve stimulation'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",42.0,0.0215565,Krauskal-Wallis test did not show any significant difference in the pre-intervention sleep quality scores (H=0.379 P=0.827).,"[{'ForeName': 'Ganiyu', 'Initials': 'G', 'LastName': 'Sokunbi', 'Affiliation': 'Physiotherapy Department, Faculty of Allied Health WSciences, Bayero University, Kano. Nigeria. Electronic address: ganiyusokunbi@gmail.com.'}, {'ForeName': 'Ibrahim Usman', 'Initials': 'IU', 'LastName': 'Kakai', 'Affiliation': 'Obstrtrics and Gynaecology Department, Faculty of Clinical Sciences, Bayero University Kano, Kano. Nigeria. Electronic address: ikakai.obg@buk.edu.ng.'}, {'ForeName': 'Ifeoma Blessing', 'Initials': 'IB', 'LastName': 'Nwosu', 'Affiliation': 'Department of Medical Rehabilitationb, Nnamdi Azikwe University, Nigeria. Electronic address: iphiedoc@gmail.com.'}, {'ForeName': 'Rasheedat', 'Initials': 'R', 'LastName': 'Balarabe', 'Affiliation': 'Physiotherapy Department, Faculty of Allied Health WSciences, Bayero University, Kano. Nigeria. Electronic address: Rashida34482971@gmail.com.'}]",Journal of acupuncture and meridian studies,['10.1016/j.jams.2020.10.003']
1636,33137547,Impact of a medical mobile phone app (QUiPP) for predicting preterm birth on the anxiety and decisional conflicts faced by women in threatened preterm labour.,"BACKGROUND
The QUiPP app is a free, validated mobile phone application (app) that supports clinical decision-making for women in threatened preterm labour by providing an individualised risk of delivery within clinically important time points. Alongside generating a percentage risk score, the QUiPP app also provides the risk score in an infographic donut chart, allowing the clinician to communicate with the woman in an easy to understand format. Informing women of their risk status using the QUIPP app may help to reduce anxiety in women and decrease decisional conflict.
METHOD
A subset of participants from the EQUIPTT study [REC Ref. 17/LO/1802] were asked to complete a questionnaire booklet which was used to evaluate decisional conflict and anxiety. Seven sites were randomised to the QUiPP app intervention (to use as a decision and communication tool) and six sites were randomised to the control (continued their normal practice). The first section of the questionnaire booklet was completed by the woman before her assessment, and the second section after. The pre and postassessment anxiety scores utilised the Visual Analogue Scale for Anxiety (Hornblow and Kidson, 1976). The Decisional Conflict Scale (O'Connor, 1995) measured decisional conflict post assessment. The data were then analysed to determine the impact of the QUiPP App on the anxiety and decisional conflicts faced by women in threatened preterm labour.
RESULTS
Questionnaires were completed by 221 women from 12 of the potential 13 sites. After exclusions 202 questionnaires were included in the analysis. There was a significant reduction in difference between anxiety scores before and after clinical assessment. While there were reductions in anxiety and decisional conflict for women who were aware of the QUiPP app use, this failed to reach statistical significance.
CONCLUSIONS
The QUiPP app has potential to reduce anxiety and decisional conflict in women who are aware that it is being used in their care. Additional work is required to ensure clinicians are aware of the QUiPP app and optimise using it as a communication tool when counselling women.",2020,The QUiPP app has potential to reduce anxiety and decisional conflict in women who are aware that it is being used in their care.,"['women in threatened preterm labour', '221 women from 12 of the potential 13 sites']","['QUiPP', 'medical mobile phone app (QUiPP', 'QUiPP app intervention']","['anxiety and decisional conflict', 'anxiety scores', ""Decisional Conflict Scale (O'Connor, 1995) measured decisional conflict post assessment"", 'decisional conflict and anxiety', 'pre and postassessment anxiety scores utilised the Visual Analogue Scale for Anxiety (Hornblow and Kidson, 1976']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",202.0,0.0402312,The QUiPP app has potential to reduce anxiety and decisional conflict in women who are aware that it is being used in their care.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Carlisle', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH. Electronic address: naomi.h.carlisle@kcl.ac.uk.""}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Watson', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH.""}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Carter', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kuhrt', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH.""}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Tribe', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH.""}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH.""}]",Midwifery,['10.1016/j.midw.2020.102864']
1637,33137579,"Supporting Play, Exploration, and Early Development Intervention (SPEEDI) for preterm infants: A feasibility randomised controlled trial in an Australian context.","BACKGROUND
An early intervention that enhances early development in infants born preterm, called 'Supporting Play, Exploration and Early Development Intervention' (SPEEDI) has been shown to be feasible in Virginia, United States, in a pilot study. Infants receive 10 therapy sessions until 3 months' corrected age (CA) (Phase 1[5 hospital sessions] and Phase 2[5 home-based sessions]) in addition to usual care.
AIMS
To determine the feasibility of SPEEDI for very preterm infants in an Australian context.
STUDY DESIGN
Prospective pilot feasibility randomised controlled trial.
SUBJECTS
Infants born <30 weeks' gestation (GA), recruited between 34 and 38 +6 weeks' postmenstrual age.
OUTCOME MEASURES
Primary outcome was feasibility of SPEEDI, including recruitment rate, participant retention, sessions delivered, and therapy fidelity. Secondary outcome measures were developmental outcomes, including the Bayley Scales of Infant and Toddler Development - 3rd Edition (BSID-III) at 4 months' CA.
RESULTS
Of 19 eligible infants, 17 consented, SPEEDI n = 8 and usual care n = 9 (mean GA = 26.7 weeks [SD 1.4], male n = 10). All participants completed the study, with 80% of SPEEDI therapy sessions completed (90% Phase 1; 72% Phase 2). On average, therapists and parents used 78% and 77% of SPEEDI strategies in each session respectively. Infants in the SPEEDI group had higher scores on the BSID-III for gross motor, and expressive and receptive language subscales at 4 months' CA.
CONCLUSIONS
SPEEDI is a feasible intervention to deliver, and preliminary results suggest that SPEEDI may lead to improved motor and language outcomes at 4 months' CA, with results supporting future larger clinical trials.",2020,"Infants in the SPEEDI group had higher scores on the BSID-III for gross motor, and expressive and receptive language subscales at 4 months' CA.
","['preterm infants', ""Infants born <30\xa0weeks' gestation (GA), recruited between 34 and 38 +6 weeks' postmenstrual age"", 'infants born preterm', 'very preterm infants in an Australian context', '19 eligible infants, 17 consented, SPEEDI n\xa0=\xa08 and usual care']",[],"['feasibility of SPEEDI, including recruitment rate, participant retention, sessions delivered, and therapy fidelity', ""developmental outcomes, including the Bayley Scales of Infant and Toddler Development - 3rd Edition (BSID-III) at 4\xa0months' CA"", 'BSID-III for gross motor, and expressive and receptive language subscales']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]",[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0023008', 'cui_str': 'Language'}]",19.0,0.112813,"Infants in the SPEEDI group had higher scores on the BSID-III for gross motor, and expressive and receptive language subscales at 4 months' CA.
","[{'ForeName': 'Francyne', 'Initials': 'F', 'LastName': 'Finlayson', 'Affiliation': ""The University of Melbourne, 161 Barry St, Carlton, Victoria 3053, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia. Electronic address: fsamara@student.unimelb.edu.au.""}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Olsen', 'Affiliation': ""Murdoch Children's Research Institute, 50 Flemington Rd, Parkville, Victoria 3052, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia.""}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Dusing', 'Affiliation': 'University of Southern California, 1540 Alcazar St #155, Los Angeles, California 90033, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Guzzetta', 'Affiliation': 'IRCCS Fondazione Stella Maris, Viale del Tirreno, 331, 56128 Calambrone, Pisa, Italy.'}, {'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Eeles', 'Affiliation': ""The University of Melbourne, 161 Barry St, Carlton, Victoria 3053, Australia; Murdoch Children's Research Institute, 50 Flemington Rd, Parkville, Victoria 3052, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia.""}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Spittle', 'Affiliation': ""The University of Melbourne, 161 Barry St, Carlton, Victoria 3053, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia.""}]",Early human development,['10.1016/j.earlhumdev.2020.105172']
1638,33137580,A breastfeeding support program changed breastfeeding patterns but did not affect the mothers' self-efficacy in breastfeeding at two months.,"BACKGROUND
Even though the biological norm in humans is frequent on demand breastfeeding, sparse feeding intervals have become the cultural norm in most Western countries due to a history of on schedule breastfeeding. This discrepancy between the biological basis and the culturally driven practice continues to interfere with women's ability to breastfeed.
AIM
Our aim was to describe breastfeeding patterns in 2-month-old infants before and after the implementation of a breastfeeding support program. A secondary aim was to investigate the relationship between breastfeeding patterns and the mother's self-efficacy in breastfeeding.
METHODS
The study had a baseline/intervention design and was part of a larger project aiming to revive the Ten Steps to Successful Breastfeeding program. The larger project included breastfeeding training for health care professionals and provision of breastfeeding information to parents, including information about on demand breastfeeding. Data were gathered via breastfeeding diaries (n = 79 mothers from each group) and the Breastfeeding Self-efficacy Scale-Short Form (n = 83 in the baseline group and n = 79 in the intervention group).
RESULTS
On demand breastfeeding patterns were more common in the intervention group (97.5%) than in the baseline group (74.7%) (p < 0.001), and breastfeeding sessions were more frequent in the intervention group (a median of 14 times per 24 h versus 11 times in the baseline group; p = 0.026). Self-efficacy in breastfeeding did not differ between the groups, but was higher in mothers with exclusive breastfeeding.
CONCLUSIONS
Knowledge about infants' breastfeeding behavior can strengthen on demand breastfeeding. Exclusive breastfeeding is associated with higher self-efficacy.",2020,"Self-efficacy in breastfeeding did not differ between the groups, but was higher in mothers with exclusive breastfeeding.
",['mothers with exclusive breastfeeding'],['breastfeeding training'],"['Self-efficacy', 'breastfeeding sessions', 'Breastfeeding Self-efficacy Scale-Short Form']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",,0.0233632,"Self-efficacy in breastfeeding did not differ between the groups, but was higher in mothers with exclusive breastfeeding.
","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Oras', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden. Electronic address: paola.oras@kbh.uu.se.""}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Ljungberg', 'Affiliation': 'Psychiatric Clinic, Nyköping Hospital, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hellström-Westas', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Eva-Lotta', 'Initials': 'EL', 'LastName': 'Funkquist', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}]",Early human development,['10.1016/j.earlhumdev.2020.105242']
1639,33137581,Does focus of attention alter craniocervical flexion test motor learning? A randomized controlled trial.,"OBJECTIVE
To evaluate the effects of three different foci of attention (internal, external and mixed) on motor learning using craniocervical flexion test in inexperienced participants.
METHODS
Ninety healthy young adults, with no experience in the task, practiced the craniocervical flexion test under three different focus of attention: a) Mixed Focus (internal plus external), b) Internal Focus, and c) External Focus. We assessed immediate, post-training, and retention (one week after the last training session) aspects of motor learning by quantifying (i) the activity of the superficial cervical flexors muscles, (ii) craniocervical range of motion, and (iii) the performance on the craniocervical flexion test.
RESULTS
None of the groups showed any significant immediate, post-training, or retention effects on superficial neck flexors activity and craniocervical range of motion progression. At immediate assessment, mixed focus had greater craniocervical flexion performance than external (MD 0.9, 95%CI 0.2 to 1.5), and internal foci (MD 1.4, 95%CI 0.8 to 2.1). At post-training, mixed focus led to better craniocervical performance compared to external (MD 1.6, 95%CI 0.8 to 2.4) and internal foci (MD 2.7, 95%CI 1.9 to 3.5). External focus had better scores on the craniocervical flexion test performance than internal focus (MD 1.1, 95%CI 0.3 to 1.9). Results remained similar at retention, with mixed focus being superior to internal (MD 2.3, 95%CI 1.7 to 3) and external foci (MD 1.5, 95%CI 0.9 to 2.1) on craniocervical flexion test performance. Similarly, the performance on the craniocervical flexion test performance remained similar at retention between external and internal foci (MD 0.9, 95%CI 0.2 to 1.5).
CONCLUSION
In inexperienced asymptomatic participants, different foci of attention were not able to change cervical muscle activity and craniocervical range of motion during the craniocervical flexion test. Mixed focus was better than external and internal focus on the craniocervical flexion test. These findings were retained after one week.",2020,"None of the groups showed any significant immediate, post-training, or retention effects on superficial neck flexors activity and craniocervical range of motion progression.","['Ninety healthy young adults, with no experience in the task, practiced the craniocervical flexion test under three different focus of attention: a', 'inexperienced participants']","['motor learning by quantifying (i) the activity of the superficial cervical flexors muscles, (ii) craniocervical range of motion, and (iii) the performance on the craniocervical flexion test', 'Mixed Focus (internal plus external), b) Internal Focus, and c', 'foci of attention (internal, external and mixed']","['craniocervical flexion performance', 'superficial neck flexors activity and craniocervical range of motion progression', 'craniocervical performance', 'craniocervical flexion test performance']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}]",90.0,0.05819,"None of the groups showed any significant immediate, post-training, or retention effects on superficial neck flexors activity and craniocervical range of motion progression.","[{'ForeName': 'Maurício', 'Initials': 'M', 'LastName': 'Scholl Schell', 'Affiliation': 'Physical Therapy Department, Post Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil. Electronic address: mauriciosc@ufcpsa.edu.br.'}, {'ForeName': 'Francisco Xavier', 'Initials': 'FX', 'LastName': 'de Araujo', 'Affiliation': 'Physical Therapy Department, Post Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil; Physical Therapy Department, Centro Universitário Ritter dos Reis - UniRitter, Porto Alegre, Brazil.'}, {'ForeName': 'Rosicler', 'Initials': 'R', 'LastName': 'da Rosa Almeida', 'Affiliation': 'Physical Therapy Department, Undergraduate Program, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Brazil.'}, {'ForeName': 'Ian Sulzbacher', 'Initials': 'IS', 'LastName': 'Peroni', 'Affiliation': 'Physical Therapy Department, Undergraduate Program, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Brazil.'}, {'ForeName': 'Carolina Gomes', 'Initials': 'CG', 'LastName': 'Rosa', 'Affiliation': 'Physical Therapy Department, Post Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Marcelo Faria', 'Initials': 'MF', 'LastName': 'Silva', 'Affiliation': 'Physical Therapy Department, Post Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil; Physical Therapy Department, Post Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil. Electronic address: marcelofs@ufcspa.edu.br.'}]",Human movement science,['10.1016/j.humov.2020.102709']
1640,33132390,Effect of Saliva Contamination on Microleakage of Open Sandwich Restorations.,"Objectives
The purpose of the present study was to evaluate the microleakage of conventional glass-ionomer, resin modified glass-ionomer and glass hybrid ionomer Class II open sandwich restorations with or without saliva contamination.
Materials and methods
Sixty extracted sound human molar teeth were used and 120 class II slot cavities were prepared in mesial and distal surfaces. The gingival margins were located 1 mm below the cementoenamel junction. All specimens were randomly divided in 4 groups (n=15): Group I: High-Viscous Glass Ionomer (Fuji IX GP) Group II: Resin Modified Glass Ionomer (Fuji II LC) Group III: Glass Hybrid Ionomer (Equia-fil Forte), Group IV: Composite Resin (G'aenial Posterior). In open sandwich restoration groups, glass ionomer materials were placed to gingival floor in 1 mm thickness and rest of the cavity was filled with resin composite. After the restorations in mesial surfaces had been performed, distal cavities were restored with the same protocol after saliva contamination. The specimens were thermo-cycled for 10000 cycles at 5 0 C to 55 0 C and immersed in methylene blue dye solution (% 0,5) for 24 hours. Then, they were sectioned vertically through the center of the restorations from mesial to distal surface with a water-cooled diamond saw with 1mm thickness. Subsequently, the dye penetration was evaluated with image analysis software. Data were statistically analyzed (p<0.05).
Results
There was a statistically significant difference between gingival microleakage scores in no contamination groups, between high-viscous glass ionomer, Fuji IX GP and other materials tested (p<0.05). In saliva contaminated groups, there was no statistically significant difference between gingival microleakage scores (p>0.05). Additionally, there was not a statistically significant difference between the no contamination and saliva contaminated groups regardless of dental materials tested (p>0.05).
Conclusion
Within the limitations of this study, in open sandwich restorations, saliva contamination did not show an adverse effect on microleakage irrespective of dental materials tested. Glass hybrid ionomers and resin modified glass ionomers showed lower microleakage scores in gingival margins compared to high-viscous glass ionomer material in no contamination groups.",2020,Glass hybrid ionomers and resin modified glass ionomers showed lower microleakage scores in gingival margins compared to high-viscous glass ionomer material in no contamination groups.,['All specimens were randomly divided in 4 groups (n=15'],"['High-Viscous Glass Ionomer (Fuji IX GP', 'Resin Modified Glass Ionomer (Fuji II LC', ""Glass Hybrid Ionomer (Equia-fil Forte), Group IV: Composite Resin (G'aenial Posterior"", 'Saliva Contamination', 'methylene blue dye solution']","['gingival margins', 'microleakage scores', 'gingival microleakage scores', 'Microleakage of Open Sandwich Restorations']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C0671561', 'cui_str': 'fuji IX'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0213535', 'cui_str': 'Fuji II LC cement'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C4085648', 'cui_str': 'Tagalog language'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C4543503', 'cui_str': 'Sandwich'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]",60.0,0.0242599,Glass hybrid ionomers and resin modified glass ionomers showed lower microleakage scores in gingival margins compared to high-viscous glass ionomer material in no contamination groups.,"[{'ForeName': 'Çiğdem', 'Initials': 'Ç', 'LastName': 'Çelik', 'Affiliation': 'Faculty of Dentistry, Department of Restorative Dentistry, Yahşihan, Kırıkkale, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Bayraktar', 'Affiliation': 'Faculty of Dentistry, Department of Restorative Dentistry, Yahşihan, Kırıkkale, Turkey.'}, {'ForeName': 'Behiye Esra', 'Initials': 'BE', 'LastName': 'Özdemir', 'Affiliation': 'Faculty of Dentistry, Department of Restorative Dentistry, Yahşihan, Kırıkkale, Turkey.'}]",Acta stomatologica Croatica,['10.15644/asc54/3/5']
1641,33132391,Effects of Visual Stimuli from Media on the Perception of Dentofacial Esthetics.,"Objectives
The study explored whether television commercials change the perception of one's own dentofacial attractiveness and to identify if it is influenced by personality traits.
Materials and methods
The sample included 83 participants, aged 19-27 years. The experimental group (N=42) watched commercials portraying famous young individuals with high smile esthetics, bright teeth and no visible malocclusions, while the control group (N=41) watched neutral commercials (without people or visible teeth). The perception of subjects` own orofacial esthetics and its psychosocial effects were assessed a month before the exposure and immediately after it. The subjects` malocclusion severity and personality characteristics (extraversion, conscientiousness, agreeableness, neuroticism, intellect, self-esteem and perfectionism) were assessed.
Results
In their second report, respondents were inclined to report less psychosocial impacts with small differences (ranging from 0-3 scalar points on average) and less significant in the active group compared to neutral group (2 out of 7 vs. 5 out of 7 aspects). Types of visual stimuli were a significant predictor only of changes pertaining to psychological impact of dental esthetics (p=0.045; r=0.221). The intellect moderated perception of smile esthetics, after having been exposed to commercials, accentuated beautiful smiles as a suppressor (ΔR 2 =0.076; p=0.005; total model R 2 =0.347; p=0.033). In subjects with higher cognitive abilities, an increase in the self-perceived malocclusion level induced a smaller decrease in psychological impact of dental esthetics as compared to those with lower intellect.
Conclusion
Psychosocial influences of malocclusion are not stable and tend to decrease during time. However, the exposure to a high smile esthetic of other individuals can inhibit that process in persons with more severe malocclusion and higher cognitive abilities.",2020,Types of visual stimuli were a significant predictor only of changes pertaining to psychological impact of dental esthetics (p=0.045; r=0.221).,"['83 participants, aged 19-27 years']","['watched commercials portraying famous young individuals with high smile esthetics, bright teeth and no visible malocclusions, while the control group (N=41) watched neutral commercials (without people or visible teeth', 'Visual Stimuli from Media']","['subjects` malocclusion severity and personality characteristics (extraversion, conscientiousness, agreeableness, neuroticism, intellect, self-esteem and perfectionism', 'psychological impact of dental esthetics', 'Perception of Dentofacial Esthetics']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037363', 'cui_str': 'Smiling'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0024636', 'cui_str': 'Malocclusion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C0024636', 'cui_str': 'Malocclusion'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0233849', 'cui_str': 'Character trait finding'}, {'cui': 'C0015382', 'cui_str': 'Extroversion, Psychological'}, {'cui': 'C1842981', 'cui_str': 'Neuroticism Traits'}, {'cui': 'C2981149', 'cui_str': 'Intellect'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0815110', 'cui_str': 'Perfectionism'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0014902', 'cui_str': 'Aesthetics, Dental'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}]",83.0,0.0196402,Types of visual stimuli were a significant predictor only of changes pertaining to psychological impact of dental esthetics (p=0.045; r=0.221).,"[{'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Laus', 'Affiliation': 'Public Health Center Karlovac.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Kovačević Pavičić', 'Affiliation': 'University of Rijeka, Faculty of Dental Medicine, Department of Prosthodontics, Rijeka, Croatia and J. J. Strossmayer University of Osijek, Faculty of Dental Medicine and Health, Department of Dental Medicine 2, Osijek, Croatia.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brumini', 'Affiliation': 'Public Health Center Rijeka.'}, {'ForeName': 'Vjera', 'Initials': 'V', 'LastName': 'Perković', 'Affiliation': 'University of Rijeka, Faculty of Dental Medicine, Department of Orthodontics, Rijeka, Croatia.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Pavlić', 'Affiliation': 'University of Rijeka, Faculty of Dental Medicine, Department of Orthodontics, Rijeka, Croatia.'}, {'ForeName': 'Stjepan', 'Initials': 'S', 'LastName': 'Špalj', 'Affiliation': 'University of Rijeka, Faculty of Dental Medicine, Department of Orthodontics, Rijeka, Croatia and J. J. Strossmayer University of Osijek, Faculty of Dental Medicine and Health, Department of Dental Medicine 1, Osijek, Croatia.'}]",Acta stomatologica Croatica,['10.15644/asc54/3/6']
1642,33132519,How does physical guidance affect motor learning and learner's workload?,"[Purpose] Physical guidance is routinely used in clinical practices such as rehabilitation to facilitate motor learning. Physical guidance would facilitate motor learning and reduce the workload; however, this relationship is unknown. Thus, we aimed to investigate this relationship using a physical guidance device. [Participants and Methods] Twenty-seven healthy young adults were randomly assigned to three groups and underwent varying practice conditions. The participants used a physical guidance device during practice for 2 days, did not use the device during practice for 2 days, or used the device on the first but not the second practice day. Motor learning was assessed by measuring the instability generated by the participants while maintaining a standing position on the Biodex Balance System. Psychological status was evaluated by analyzing the participants' responses to the National Aeronautics and Space Administration-Task Load Index. [Results] Improved performance was noted in all participants; however, those who used a physical guidance device during practice for 2 days exhibited poor motor learning compared with those assigned to the other two conditions. Frustration was significantly lower in participants who used a physical guidance device during practice than those who did not. [Conclusion] The use of physical guidance during practice can reduce participant frustration, but excessive physical guidance during practice reduces learning efficiency.",2020,Frustration was significantly lower in participants who used a physical guidance device during practice than those who did not.,['Participants and Methods] Twenty-seven healthy young adults'],[],"['Motor learning', 'Psychological status', 'Frustration']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0016770', 'cui_str': 'Feeling frustrated'}]",27.0,0.0166971,Frustration was significantly lower in participants who used a physical guidance device during practice than those who did not.,"[{'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Misato Central General Hospital: 4-5-1 Chuo, Misato-shi, Saitama 341-0038, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Akizuki', 'Affiliation': 'Department of Physical Therapy, Kobe International University, Japan.'}, {'ForeName': 'Ryohei', 'Initials': 'R', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Rehabilitation, Kyushu University of Nursing and Social Welfare, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yabuki', 'Affiliation': 'Graduate School of Health Sciences, Ibaraki Prefectural University of Health Sciences, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Department of Physical Therapy, Ibaraki Prefectural University of Health Sciences, Japan.'}]",Journal of physical therapy science,['10.1589/jpts.32.621']
1643,33132525,Effects of an exercise program with video: targeting older female residents in a remote island.,"[Purpose] This study aimed to consider the influence of a three-month video exercise program on the physical function of older females. [Participants and Methods] Nineteen older females (aged 72.9 ± 3.64 years) participated in this study. We formed two groups-an experimental group that exercised (n=9) and a control group that did not exercise (n=10). Our study's exercise program focused on leg training. We conducted physical and cognitive tests before and after the program to determine the effects of the exercise program. [Results] The results of the second physical (post-intervention) test showed that the exercise group recorded significant improvement in the one-leg balance test with eyes open. However, no improvement was observed in cognitive function. [Conclusion] The static balance capacity of the exercise group improved. Thus, the three-month video exercise practice was effective for physical function improvement.",2020,The static balance capacity of the exercise group improved.,"['Nineteen older females (aged 72.9 ± 3.64\u2005years) participated in this study', 'Participants and Methods', 'older female residents in a remote island', 'older females']","['exercise program with video', 'control group that did not exercise', 'video exercise program']","['leg balance test', 'cognitive function', 'static balance capacity']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517695', 'cui_str': '3.64'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0022130', 'cui_str': 'Island'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0441463', 'cui_str': 'Static'}]",19.0,0.0114783,The static balance capacity of the exercise group improved.,"[{'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Maruyama', 'Affiliation': 'Tokai Gakuen University Miyoshi Campus: 21-233 Nishinohora, Ukigai, Miyoshi, Aichi 470-0207, Japan.'}]",Journal of physical therapy science,['10.1589/jpts.32.653']
1644,33132694,Paradoxical bronchoconstriction caused by β 2 -adrenoceptor agonists.,"Introduction
Salbutamol and terbutaline are short-acting β 2 adrenergic agonists that produce bronchial smooth muscle relaxation and are widely used in obstructive pulmonary diseases. Nevertheless, their use has been the cause of a paradoxical bronchoconstriction, which is a rare and potentially serious adverse reaction. The aim of this study is to report a case of paradoxical bronchoconstriction caused by β 2 adrenergic agonists.
Methods
This case is about a 50-year-old asthmatic patient who describes a history of repeated acute asthma attacks after salbutamol inhalation or terbutaline nebulization. A double-blind crossover study was performed over 3 days, in order to compare the effects of each bronchodilator. Forced expiratory volume in 1 second (FEV 1 ), forced vital capacity (FVC), and maximal expiratory flow 25-75 (MEF25-75) were measured.
Results
On the first day, a bronchoconstriction caused by deep and repeated inhalations was eliminated. On the second day, an airway obstruction was confirmed by a decrease in FEV 1 at 40% from baseline values after nebulization of a standard dose of terbutaline. On the third day, a spirometry was performed before and after nebulization of a standard dose of ipratropium bromide, and there were no significant changes in the spirometric parameters. Finally the patient was discharged with a written warning mentioning the danger of salbutamol and terbutaline use.
Conclusion
Salbutamol and terbutaline are generally well-tolerated β 2 adrenergic agonists. Nevertheless, in rare cases, these substances can cause a paradoxical bronchoconstriction. Doctors must therefore remain vigilant about its side effect and possibly investigate each case.",2020,"Forced expiratory volume in 1 second (FEV 1 ), forced vital capacity (FVC), and maximal expiratory flow 25-75 (MEF25-75) were measured.
",['50-year-old asthmatic patient who describes a history of repeated acute asthma attacks after salbutamol inhalation or terbutaline nebulization'],"['Salbutamol and terbutaline', 'ipratropium bromide']","['Forced expiratory volume in 1 second (FEV 1 ), forced vital capacity (FVC), and maximal expiratory flow 25-75 (MEF25-75', 'spirometric parameters', 'airway obstruction']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0582415', 'cui_str': 'Acute asthma'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0039542', 'cui_str': 'Terbutaline'}]","[{'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0039542', 'cui_str': 'Terbutaline'}, {'cui': 'C0700580', 'cui_str': 'ipratropium bromide'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001883', 'cui_str': 'Respiratory obstruction'}]",75.0,0.0466343,"Forced expiratory volume in 1 second (FEV 1 ), forced vital capacity (FVC), and maximal expiratory flow 25-75 (MEF25-75) were measured.
","[{'ForeName': 'Khadija', 'Initials': 'K', 'LastName': 'Ayed', 'Affiliation': 'Department of Physiology, Faculty of Medicine of Tunis, University of Tunis el Manar, Tunis - Tunisia.'}, {'ForeName': 'Islam Latifa Hadj', 'Initials': 'ILH', 'LastName': 'Khalifa', 'Affiliation': 'Department of Physiology, Faculty of Medicine of Tunis, University of Tunis el Manar, Tunis - Tunisia.'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Mokaddem', 'Affiliation': 'Department of Physiology, Faculty of Medicine of Tunis, University of Tunis el Manar, Tunis - Tunisia.'}, {'ForeName': 'Saloua Ben Khamsa', 'Initials': 'SBK', 'LastName': 'Jameleddine', 'Affiliation': 'Department of Physiology, Faculty of Medicine of Tunis, University of Tunis el Manar, Tunis - Tunisia.'}]",Drug target insights,['10.33393/dti.2020.2188']
1645,33132718,Efficacy of lidocaine versus mepivacaine in the management of myofascial pain.,"Objectives
There are many treatment modalities for myofascial pain, and recent findings reported in the literature highlight the superiority of using local anesthetics as the treatment of choice. The objective of the present study was to compare the effectiveness of two of the most used local anesthetic agents-lidocaine and mepivacaine-in the management of myofascial pain.
Materials and methods
Thirty patients (20 females, 10 males) were randomly assigned to one of two groups: 50% received lidocaine and 50% received mepivacaine. Trigger point injections in the orofacial region were administered 4 times, 10 days between each injection, with 4 weeks of follow-up after the end of the treatment course. Pain levels were recorded using a visual analog scale (VAS) at the time of follow-up and 30 min after injection.
Results
All patients exhibited statistically significant improvement when comparing pre- and post-treatment mean values. Both local anesthetics (i.e., lidocaine and mepivacaine) were similarly effective for the management of myofascial pain (p = 0.875). The mepivacaine-treated group exhibited significantly lower post-injection tenderness than the lidocaine group (p = 0.038). There was no relationship between sex and treatment response. Female and male patients both reported similar responses in terms of VAS scores (p = 0.818).
Conclusion
No drug was superior in the long term; thus, the clinician's choice can be based on drug availability and patient medical history.",2020,"Both local anesthetics (i.e., lidocaine and mepivacaine) were similarly effective for the management of myofascial pain (p = 0.875).","['Thirty patients (20 females, 10 males', 'Female and male patients']","['lidocaine and mepivacaine', 'mepivacaine', 'lidocaine']","['myofascial pain', 'VAS scores', 'visual analog scale (VAS', 'Pain levels', 'post-injection tenderness']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}]","[{'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}]",,0.0445711,"Both local anesthetics (i.e., lidocaine and mepivacaine) were similarly effective for the management of myofascial pain (p = 0.875).","[{'ForeName': 'Hamad', 'Initials': 'H', 'LastName': 'Albagieh', 'Affiliation': 'Oral Medicine and Diagnostic Science Department, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ashwag', 'Initials': 'A', 'LastName': 'Aloyouny', 'Affiliation': 'Basic Dental Sciences, College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Nojoud', 'Initials': 'N', 'LastName': 'Alshehri', 'Affiliation': 'Restorative Department, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Alsammahi', 'Affiliation': 'Clinical Dental Science Department, College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Dima', 'Initials': 'D', 'LastName': 'Almutrafi', 'Affiliation': 'Dental Clinic, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Hadlaq', 'Affiliation': 'Oral Medicine and Diagnostic Science Department, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}]",Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society,['10.1016/j.jsps.2020.08.014']
1646,33132877,Reduced Frontal Nogo-N2 With Uncompromised Response Inhibition During Transcutaneous Vagus Nerve Stimulation-More Efficient Cognitive Control?,"We have previously shown invasive vagus nerve stimulation to improve attention and working memory and alter emotion-attention interaction in patients with refractory epilepsy, suggesting that VNS might be useful in the treatment of cognitive impairment. The current research focuses on whether non-invasive, transcutaneous vagus nerve stimulation (tVNS) has similar effects to VNS. Furthermore, we aimed to assess whether tVNS has an impact on cognitive control in general or on underlying brain physiology in a task that mimics everyday life demands where multiple executive functions are engaged while encountering intervening emotional stimuli. Event-related potentials (ERP) evoked in such a task, specifically centro-parietal P3 and frontal N2 were used as biomarkers for attention allocation and cognitive control required to carry out the task. A single-blinded, sham-controlled, within-subject study on healthy subjects ( n = 25) was conducted using Executive Reaction Time Test (RT-test), a Go/NoGo task engaging multiple executive functions along with intervening threat-related distractors while EEG was recorded. tVNS at the left tragus and sham stimulation at the left ear lobe was alternately delivered throughout the task. To assess the impact of tVNS on neural activity underlying attention and cognitive control, centro-parietal P3 and frontal N2 peak amplitudes were measured in Go and NoGo conditions. Task performance was assessed with RTs and different error types reflecting cognitive control in general and distinct executive functions, such as working memory and response inhibition.No significant effects due to tVNS on performance in the Executive RT-test were observed. For N2 there was a main effect of stimulator status and a significant interaction of trial type (Go, NoGo) and stimulator status. Post hoc analysis revealed that tVNS resulted in a significant reduction of frontal N2 only in the NoGo condition. No significant effects were observed for P3 nor were there any effects of emotion. Diminished NoGo-N2 potential along with unaltered task performance during tVNS suggests fewer cognitive control resources were required to successfully withhold a prepotent response. Though caution is warranted, we suggest that tVNS may lead to more efficient neural processing with fewer resources needed for successful cognitive control, providing promise for its potential use in cognitive enhancement.",2020,"Event-related potentials (ERP) evoked in such a task, specifically centro-parietal P3 and frontal N2 were used as biomarkers for attention allocation and cognitive control required to carry out the task.","['healthy subjects ( n = 25', 'patients with refractory epilepsy']","['Executive Reaction Time Test (RT-test), a Go/NoGo task engaging multiple executive functions along with intervening threat-related distractors while EEG', 'Transcutaneous Vagus Nerve Stimulation', 'tVNS', 'transcutaneous vagus nerve stimulation (tVNS']","['Task performance', 'Executive RT-test', 'neural activity underlying attention and cognitive control, centro-parietal P3 and frontal N2 peak amplitudes', 'Reduced Frontal Nogo-N2 With Uncompromised Response Inhibition']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",,0.0405584,"Event-related potentials (ERP) evoked in such a task, specifically centro-parietal P3 and frontal N2 were used as biomarkers for attention allocation and cognitive control required to carry out the task.","[{'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Pihlaja', 'Affiliation': 'Behavioral Neurology Research Unit, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Failla', 'Affiliation': 'Behavioral Neurology Research Unit, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Peräkylä', 'Affiliation': 'Behavioral Neurology Research Unit, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Kaisa M', 'Initials': 'KM', 'LastName': 'Hartikainen', 'Affiliation': 'Behavioral Neurology Research Unit, Tampere University Hospital, Tampere, Finland.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.561780']
1647,33132880,Effects of Diazepam on Reaction Times to Stop and Go.,"Introduction : The ability to stop the execution of a movement in response to an external cue requires intact executive function. The effect of psychotropic drugs on movement inhibition is largely unknown. Movement stopping can be estimated by the Stop Signal Reaction Time (SSRT). In a recent publication, we validated an improved measure of SSRT (optimum combination SSRT, ocSSRT). Here we explored how diazepam, which enhances transmission at GABA A receptors, affects ocSSRT. Methods : Nine healthy individuals were randomized to receive placebo, 5 mg or 10 mg doses of diazepam. Each participant received both the dosage of drug and placebo orally on separate days with adequate washout. The ocSSRT and simple reaction time (RT) were estimated through a stop-signal task delivered via a battery-operated box incorporating green (Go) and red (Stop) light-emitting diodes. The task was performed just before and 1 h after dosing. Result : The mean change in ocSSRT after 10 mg diazepam was significantly higher (+27 ms) than for placebo (-1 ms; p = 0.012). By contrast, the mean change in simple response time remained comparable in all three dosing groups ( p = 0.419). Conclusion : Our results confirm that a single therapeutic adult dose of diazepam can alter motor inhibition in drug naïve healthy individuals. The selective effect of diazepam on ocSSRT but not simple RT suggests that GABAergic neurons may play a critical role in movement-stopping.",2020,"By contrast, the mean change in simple response time remained comparable in all three dosing groups ( p = 0.419). ","['Nine healthy individuals', 'drug naïve healthy individuals']","['Diazepam', 'diazepam', 'placebo', 'psychotropic drugs']","['mean change in simple response time', 'ocSSRT and simple reaction time (RT', 'motor inhibition', 'Reaction Times to Stop and Go', 'mean change in ocSSRT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0450446', 'cui_str': 'Stops'}]",9.0,0.0676216,"By contrast, the mean change in simple response time remained comparable in all three dosing groups ( p = 0.419). ","[{'ForeName': 'Swagata', 'Initials': 'S', 'LastName': 'Sarkar', 'Affiliation': 'Department of Neurology, Institute of Neurosciences Kolkata, Kolkata, India.'}, {'ForeName': 'Supriyo', 'Initials': 'S', 'LastName': 'Choudhury', 'Affiliation': 'Department of Neurology, Institute of Neurosciences Kolkata, Kolkata, India.'}, {'ForeName': 'Nazrul', 'Initials': 'N', 'LastName': 'Islam', 'Affiliation': 'Department of Neurology, National Institute of Neurosciences and Hospital, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad Shah Jahirul Hoque', 'Initials': 'MSJH', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Neurology, National Institute of Neurosciences and Hospital, Dhaka, Bangladesh.'}, {'ForeName': 'Md Tauhidul Islam', 'Initials': 'MTI', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Neurology, National Institute of Neurosciences and Hospital, Dhaka, Bangladesh.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Baker', 'Affiliation': 'Department of Neurology, Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Stuart N', 'Initials': 'SN', 'LastName': 'Baker', 'Affiliation': 'The Medical School, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Kumar', 'Affiliation': 'Department of Neurology, Institute of Neurosciences Kolkata, Kolkata, India.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.567177']
1648,33132882,Does Cardiorespiratory Fitness Influence the Effect of Acute Aerobic Exercise on Executive Function?,"Background
The beneficial effects of acute exercise on executive function have been well-documented, but the influence of cardiorespiratory fitness on this effect requires further investigations, especially using imaging technique. This study aimed to examine the effects of cardiorespiratory fitness on acute exercise-induced changes on behavioral performance and on functional brain activation.
Method
Based on their cardiorespiratory fitness level, 62 participants ranked in the top and bottom of the maximum oxygen consumption (VO 2 max) were finally selected and allocated to high-fit group or low-fit group. Both groups were asked to complete the Stroop task after 30 min of aerobic exercise and chair-seated rest (control session). Among them, 26 participants were randomly selected and asked to undergo the Functional Magnetic Resonance Imaging (fMRI).
Results
Behavioral results showed that individuals responded significantly faster after exercise than those in the control session. The fMRI results revealed a significant interaction effects of Group by Session in brain regions including anterior cingulate cortex (ACC) and bilateral dorsal lateral prefrontal cortex (DLPFC). For the ACC, activation in the high-fit group was significantly decreased after aerobic exercise compared to those in the control session; whereas an increased activation was noticed in the low-fit group. Regarding to the bilateral DLPFC, activation in high-fit group was significantly decreased after exercise compared to those in the control session, while no significant differences were found in the low-fit group. In addition, for the post-exercise session, a significant positive correlations between activation of the ACC and left DLPFC in the high-fit group was observed. There was a significant negative correlation between activation of the ACC and reaction time in the congruent condition after exercise in the low-fit group.
Conclusion
Findings further clarify the neurophysiological processes of acute exercise-induced changes in cognitive performance as they suggest that cardiorespiratory fitness is an important factor which influences changes in brain activation patterns in response to acute aerobic exercises.",2020,"For the ACC, activation in the high-fit group was significantly decreased after aerobic exercise compared to those in the control session; whereas an increased activation was noticed in the low-fit group.","['62 participants ranked in the top and bottom of the maximum oxygen consumption (VO 2 max', '26 participants']","['Functional Magnetic Resonance Imaging (fMRI', 'aerobic exercise and chair-seated rest (control session', 'Acute Aerobic Exercise']","['ACC and reaction time', 'cognitive performance', 'behavioral performance', 'anterior cingulate cortex (ACC) and bilateral dorsal lateral prefrontal cortex (DLPFC', 'activation']","[{'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",62.0,0.0210068,"For the ACC, activation in the high-fit group was significantly decreased after aerobic exercise compared to those in the control session; whereas an increased activation was noticed in the low-fit group.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': 'College of Physical Education and Health, East China Normal University, Shanghai, China.'}, {'ForeName': 'Liye', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Exercise and Mental Health Laboratory, School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Herold', 'Affiliation': 'Research Group Neuroprotection, German Center for Neurodegenerative Diseases, Magdeburg, Germany.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Exercise and Mental Health Laboratory, School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Jiao', 'Affiliation': 'Exercise and Mental Health Laboratory, School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Yanjie', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Exercise and Mental Health Laboratory, School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Xinli', 'Initials': 'X', 'LastName': 'Chi', 'Affiliation': 'Exercise and Mental Health Laboratory, School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Notger G', 'Initials': 'NG', 'LastName': 'Müller', 'Affiliation': 'Research Group Neuroprotection, German Center for Neurodegenerative Diseases, Magdeburg, Germany.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Perrey', 'Affiliation': 'EuroMov Digital Health in Motion, Univ Montpellier, IMT Mines Ales, Montpellier, France.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'College of Physical Education and Health, East China Normal University, Shanghai, China.'}, {'ForeName': 'Chenbo', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Brain Functional Genomics, MOE & STCSM, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.569010']
1649,33132906,"A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy Subjects.","Objective
This study was conducted to explore the tolerance, variability, pharmacokinetics (PK), and pharmacodynamics (PD) of denosumab biosimilar (QL1206) in healthy Chinese subjects.
Methods
This is a randomized, double-blind, two-arm, parallel study performed to examine the bioequivalence of denosumab biosimilar, QL1206, with that of Xgeva ® (Denosumab) as a reference drug. A single dose of 120 mg/kg of the denosumab biosimilar or Xgeva ® was administered to the subjects, who were followed up for 134 days.
Results
Similar PK properties as those of Xgeva ® were exhibited by QL1206. When compared to QL1206 with Xgeva ® , the 90% confidence intervals of the ratios for C max , AUC 0-t , and AUC 0-∞ were observed to be within 80-125%. The inter-subject variability (inter-CV) ranged from 29% to 39.5%. Six and three subjects in the QL1206 and Xgeva ® groups were found to be positive for the ADA and negative for the NAb, respectively. The CTX1 concentration-time profiles appeared similar (about 80% decrease from 48 hours to134 days) between the QL1206 and Xgeva ® groups. Adverse events (AEs) were observed in 92.6% and 93.4% of subjects in the QL1206 and Xgeva ® groups, respectively. Reduction in blood calcium level was found to be the most common AE recorded, with an incidence of 72.8% versus 72.4% in the QL1206 and Xgeva ® groups, respectively.
Conclusion
Similar PK and PD characteristics were exhibited by QL1206 as compared to those of Xgeva ® . The inter-CV was slightly large. The safety profiles of denosumab biosimilars and Xgeva ® were found to be similar.",2020,"Six and three subjects in the QL1206 and Xgeva ® groups were found to be positive for the ADA and negative for the NAb, respectively.","['healthy Chinese subjects', 'Chinese Healthy Subjects']","['denosumab biosimilar or Xgeva ®', 'denosumab biosimilar, QL1206, with that of Xgeva ® (Denosumab', 'QL1206 to Denosumab']","['ratios for C max , AUC 0-t , and AUC 0-∞', 'blood calcium level', 'CTX1 concentration-time profiles', 'Adverse events (AEs', 'tolerance, variability, pharmacokinetics (PK), and pharmacodynamics (PD) of denosumab biosimilar (QL1206']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C2949325', 'cui_str': 'Xgeva'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0729820', 'cui_str': 'Blood calcium measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]",,0.0617038,"Six and three subjects in the QL1206 and Xgeva ® groups were found to be positive for the ADA and negative for the NAb, respectively.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase I\xa0Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Phase I\xa0Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Phase I\xa0Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Cuiyun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Phase I\xa0Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Phase I\xa0Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Jixuan', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Phase I\xa0Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Chengjiao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Phase I\xa0Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Institute of Translational Medicine, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Institute of Virology and AIDS Research, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Junqi', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'Department of Hepatology, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Phase I\xa0Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}]",Frontiers in pharmacology,['10.3389/fphar.2020.01329']
1650,33132997,Neural Connectivity Changes Facilitated by Familiar Auditory Sensory Training in Disordered Consciousness: A TBI Pilot Study.,"For people with disordered consciousness (DoC) after traumatic brain injury (TBI), relationships between treatment-induced changes in neural connectivity and neurobehavioral recovery have not been explored. To begin building a body of evidence regarding the unique contributions of treatments to changes in neural network connectivity relative to neurobehavioral recovery, we conducted a pilot study to identify relationships meriting additional examination in future research. To address this objective, we examined previously unpublished neural connectivity data derived from a randomized clinical trial (RCT). We leveraged these data because treatment efficacy, in the RCT, was based on a comparison of a placebo control with a specific intervention, the familiar auditory sensory training (FAST) intervention, consisting of autobiographical auditory-linguistic stimuli. We selected a subgroup of RCT participants with high-quality imaging data (FAST n = 4 and placebo n = 4) to examine treatment-related changes in brain network connectivity and how and if these changes relate to neurobehavioral recovery. To discover promising relationships among the FAST intervention, changes in neural connectivity, and neurobehavioral recovery, we examined 26 brain regions and 19 white matter tracts associated with default mode, salience, attention, and language networks, as well as three neurobehavioral measures. Of the relationships discovered, the systematic filtering process yielded evidence supporting further investigation of the relationship among the FAST intervention, connectivity of the left inferior longitudinal fasciculus, and auditory-language skills. Evidence also suggests that future mechanistic research should focus on examining the possibility that the FAST supports connectivity changes by facilitating redistribution of brain resources. For a patient population with limited treatment options, the reported findings suggest that a simple, yet targeted, passive sensory stimulation treatment may have altered functional and structural connectivity. If replicated in future research, then these findings provide the foundation for characterizing the unique contributions of the FAST intervention and could inform development of new treatment strategies. For persons with severely damaged brain networks, this report represents a first step toward advancing understanding of the unique contributions of treatments to changing brain network connectivity and how these changes relate to neurobehavioral recovery for persons with DoC after TBI. Clinical Trial Registry: NCT00557076, The Efficacy of Familiar Voice Stimulation During Coma Recovery (http://www.clinicaltrials.gov).",2020,"Of the relationships discovered, the systematic filtering process yielded evidence supporting further investigation of the relationship among the FAST intervention, connectivity of the left inferior longitudinal fasciculus, and auditory-language skills.","['persons with DoC after TBI', 'Disordered Consciousness', 'For people with disordered consciousness (DoC) after traumatic brain injury (TBI', 'subgroup of RCT participants with high-quality imaging data (FAST n = 4 and placebo n = 4']","['familiar auditory sensory training (FAST) intervention, consisting of autobiographical auditory-linguistic stimuli', 'Neural Connectivity Changes Facilitated by Familiar Auditory Sensory Training', 'Familiar Voice Stimulation During Coma Recovery (http://www.clinicaltrials.gov']","['neural connectivity, and neurobehavioral recovery']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009421', 'cui_str': 'Coma'}]",[],,0.0642519,"Of the relationships discovered, the systematic filtering process yielded evidence supporting further investigation of the relationship among the FAST intervention, connectivity of the left inferior longitudinal fasciculus, and auditory-language skills.","[{'ForeName': 'Theresa L', 'Initials': 'TL', 'LastName': 'Bender Pape', 'Affiliation': 'The Department of Veterans Affairs (VA), Center for Innovation in Complex Chronic Healthcare & Research Service, Edward Hines Jr. VA Hospital, Hines, IL, United States.'}, {'ForeName': 'Sherri L', 'Initials': 'SL', 'LastName': 'Livengood', 'Affiliation': 'The Department of Veterans Affairs (VA), Center for Innovation in Complex Chronic Healthcare & Research Service, Edward Hines Jr. VA Hospital, Hines, IL, United States.'}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Kletzel', 'Affiliation': 'The Department of Veterans Affairs (VA), Center for Innovation in Complex Chronic Healthcare & Research Service, Edward Hines Jr. VA Hospital, Hines, IL, United States.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Blabas', 'Affiliation': 'The Department of Veterans Affairs (VA), Center for Innovation in Complex Chronic Healthcare & Research Service, Edward Hines Jr. VA Hospital, Hines, IL, United States.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Guernon', 'Affiliation': 'The Department of Veterans Affairs (VA), Center for Innovation in Complex Chronic Healthcare & Research Service, Edward Hines Jr. VA Hospital, Hines, IL, United States.'}, {'ForeName': 'Dulal K', 'Initials': 'DK', 'LastName': 'Bhaumik', 'Affiliation': 'Division of Epidemiology and Biostatistics, Department of Psychiatry, Biostatistical Research Center, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Runa', 'Initials': 'R', 'LastName': 'Bhaumik', 'Affiliation': 'Division of Epidemiology and Biostatistics, Department of Psychiatry, Biostatistical Research Center, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Trudy', 'Initials': 'T', 'LastName': 'Mallinson', 'Affiliation': 'Department of Clinical Research and Leadership, School of Medicine and Health Sciences, The George Washington University, Washington, DC, United States.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Weaver', 'Affiliation': 'Department of Clinical Research and Leadership, School of Medicine and Health Sciences, The George Washington University, Washington, DC, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Higgins', 'Affiliation': 'Department of Radiology, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Herrold', 'Affiliation': 'The Department of Veterans Affairs (VA), Center for Innovation in Complex Chronic Healthcare & Research Service, Edward Hines Jr. VA Hospital, Hines, IL, United States.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Rosenow', 'Affiliation': 'Department of Neurological Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Parrish', 'Affiliation': 'Department of Radiology, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}]",Frontiers in neurology,['10.3389/fneur.2020.01027']
1651,33133002,Electroencephalography Mu Rhythm Changes and Decreased Spasticity After Repetitive Peripheral Magnetic Stimulation in Patients Following Stroke.,"Background: Spasticity is common among patients with stroke. Repetitive peripheral magnetic stimulation (rPMS) is a painless and noninvasive therapy that is a promising approach to reducing spasticity. However, the central mechanism of this therapy remains unclear. Changes in cortical activity and decreased spasticity after rPMS intervention require further exploration. The aim of this study was to explore the electroencephalography (EEG) mu rhythm change and decrease in spasticity after rPMS intervention in patients with stroke. Materials and methods: A total of 32 patients with spasticity following stroke were recruited in this study and assigned to the rPMS group ( n = 16) or sham group ( n = 16). The modified Ashworth scale, modified Tardieu scale, and Fugl-Meyer assessment of the upper extremity were used to assess changes in upper limb spasticity and motor function. Before and after the rPMS intervention, EEG evaluation was performed to detect EEG mu rhythm changes in the brain. Results: After one session of rPMS intervention, spasticity was reduced in elbow flexors ( p < 0.05) and wrist flexors ( p < 0.05). Upper limb motor function measured according to the Fugl-Meyer assessment was improved ( p < 0.05). In the rPMS group, the power of event-related desynchronization decreased in the mu rhythm band (8-12 Hz) in the contralesional hemisphere ( p < 0.05). Conclusions: The results indicate that rPMS intervention reduced spasticity. Cortical activity changes may suggest this favorable change in terms of its neurological effects on the central nervous system.",2020,"After one session of rPMS intervention, spasticity was reduced in elbow flexors ( p < 0.05) and wrist flexors ( p < 0.05).","['Patients Following Stroke', 'patients with stroke', '32 patients with spasticity following stroke']","['Repetitive Peripheral Magnetic Stimulation', 'rPMS intervention', 'rPMS', 'Repetitive peripheral magnetic stimulation (rPMS']","['cortical activity and decreased spasticity', 'elbow flexors', 'Upper limb motor function', 'power of event-related desynchronization', 'Electroencephalography Mu Rhythm Changes and Decreased Spasticity', 'modified Ashworth scale, modified Tardieu scale, and Fugl-Meyer assessment of the upper extremity', 'wrist flexors', 'spasticity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0475506', 'cui_str': 'Ravens colored progressive matrices'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}]",32.0,0.0277694,"After one session of rPMS intervention, spasticity was reduced in elbow flexors ( p < 0.05) and wrist flexors ( p < 0.05).","[{'ForeName': 'Shugeng', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Rehabilitation Medicine, Shanghai Jing'an District Central Hospital, Shanghai, China.""}, {'ForeName': 'Xiaokang', 'Initials': 'X', 'LastName': 'Shu', 'Affiliation': 'School of Mechanical Engineering, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Chuankai', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hewei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}]",Frontiers in neurology,['10.3389/fneur.2020.546599']
1652,33133178,Personality Differences of Brain Networks in Placebo Analgesia and Nocebo Hyperalgesia: A Psychophysiological Interaction (PPI) Approach in fMRI.,"It is generally believed that the placebo response can elicit an analgesic effect, whilst the nocebo response can elicit a hyperalgesia effect in pain. Placebo analgesia and nocebo hyperalgesia effects are increasing concerns for researchers. Growing evidence suggests personality differences have an impact on both placebo and nocebo effects. However, previous studies have not reached a unified conclusion. We designed this study to explore the personality differences of functional magnetic resonance imaging (fMRI) signals in placebo response and nocebo response by using psychophysiological interaction (PPI) analysis. 30 healthy subjects underwent conditioning induction training to establish expectations of placebo effect and nocebo effect, and then, all subjects completed the following experimental procedures: (1) baseline scanning, (2) acute pain model establishment, (3) pain status scanning, and (4) pseudorandom scanning of block design of placebo response or nocebo response. Behavioral data were collected after each scan. The results of this study showed that (1) there were significant differences of VAS placebo intervention between the extrovert group and the introvert group ( p = 0.004); (2) there were significant differences of VAS nocebo intervention between the extrovert group and the introvert group ( p = 0.011); (3) there were significant differences between the VAS placebo intervention and VAS pain status (baseline) in both the extrovert group ( p < 0.001) and the introvert group ( p = 0.001); (4) there were significant differences between the VAS nocebo intervention and VAS pain status (baseline) in both the extrovert group ( p = 0.008) and the introvert group ( p < 0.001). Moreover, there were significant differences in the brain network for placebo and nocebo responses between different personalities. We found that (1) deactivation differences of the pain-related network and limbic system play an important role in personality differences associated with placebo analgesia and (2) differences of control of anxiety and activation of dorsolateral prefrontal cortex may cause the personality differences observed in nocebo hyperalgesia.",2020,"Moreover, there were significant differences in the brain network for placebo and nocebo responses between different personalities.","['30 healthy subjects underwent', 'and Nocebo Hyperalgesia']","['placebo response or nocebo response', 'Placebo Analgesia', 'placebo', 'conditioning induction training', 'Placebo']","['VAS placebo intervention and VAS pain status', 'VAS placebo intervention', 'VAS nocebo intervention', 'brain network', 'VAS nocebo intervention and VAS pain status', 'Behavioral data']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",30.0,0.272006,"Moreover, there were significant differences in the brain network for placebo and nocebo responses between different personalities.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.'}, {'ForeName': 'Shimin', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.'}, {'ForeName': 'Hongrui', 'Initials': 'H', 'LastName': 'Zhan', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.'}, {'ForeName': 'Guiyuan', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.'}]",Neural plasticity,['10.1155/2020/8820443']
1653,33133188,A Clinical Study Comparing the Efficacy of SesameOil with Desensitizing Tooth Paste in Reducing Dentinal Hypersensitivity: A Randomized Controlled Trial.,"Objectives
The objective of this study was to evaluate the efficacy of sesame oil therapy in reduction of dentin hypersensitivity, as compared to desensitizing dentifrice. Design, setting, participants . We conducted a single blinded randomized controlled trial in 100 patients reported to Diagnostic Department of King Khalid University-College of Dentistry between March 2018 and December 2019. Interventions . Patients were given desensitizing tooth paste or sesame oil to apply for the specified time. Main outcome measures . A Visual Analogue Scale was used to record sensitivity scores for controlled air stimulus and tactile method at the first visit and after 8th week of treatment. Measured outcome was reduction in dentinal hypersensitivity.
Results
Hypersensitivity degree before treatment in case of desensitizing tooth paste was 6.90 ± 1.04, and posttreatment showed a score of 4.70 ± 1.37. In case of sesame oil groups, subjects included had a score of 7.14 ± 0.90 which showed a drop to a score of 4.52 ± 1.16.
Conclusions
Desensitizing tooth paste showed 30.5% reduction in sensitivity, whereas sesame oil application showed 36.2% reduction. The belief of considering oil therapy in oral health is just a placebo effect and may not be considered anymore. Efficacy can be established with many more studies including long follow-up and varying time periods.",2020,"Results
Hypersensitivity degree before treatment in case of desensitizing tooth paste was 6.90 ± 1.04, and posttreatment showed a score of 4.70 ± 1.37.",['100 patients reported to Diagnostic Department of King Khalid University-College of Dentistry between March 2018 and December 2019'],"['desensitizing tooth paste or sesame oil', 'sesame oil therapy', 'SesameOil with Desensitizing Tooth Paste']","['dentinal hypersensitivity', 'Dentinal Hypersensitivity', 'sensitivity', 'Hypersensitivity degree']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0472824', 'cui_str': 'Dental application of desensitizing medicament'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0036845', 'cui_str': 'Sesame Oil'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",100.0,0.084516,"Results
Hypersensitivity degree before treatment in case of desensitizing tooth paste was 6.90 ± 1.04, and posttreatment showed a score of 4.70 ± 1.37.","[{'ForeName': 'Walaa', 'Initials': 'W', 'LastName': 'Abdullah Al Qahtani', 'Affiliation': 'King Khalid University, College of Dentistry, Abha, Saudi Arabia.'}, {'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Sandeepa', 'Affiliation': 'King Khalid University, College of Dentistry, Abha, Saudi Arabia.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Khalid Abdullah', 'Affiliation': 'King Khalid University, College of Dentistry, Abha, Saudi Arabia.'}, {'ForeName': 'Yosra', 'Initials': 'Y', 'LastName': 'Mohammed Mousa', 'Affiliation': 'King Khalid University, College of Dentistry, Abha, Saudi Arabia.'}, {'ForeName': 'Atheer', 'Initials': 'A', 'LastName': 'Abdulhade Ganem', 'Affiliation': 'King Khalid University, College of Dentistry, Abha, Saudi Arabia.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Ali Alqahtani', 'Affiliation': 'King Khalid University, College of Dentistry, Abha, Saudi Arabia.'}, {'ForeName': 'Afnan Hassan M', 'Initials': 'AHM', 'LastName': 'Alkhayri', 'Affiliation': 'King Khalid University, College of Dentistry, Abha, Saudi Arabia.'}]",International journal of dentistry,['10.1155/2020/6410102']
1654,33133410,Comparison of Bone Preservation in Elderly Patients with Femoral Neck Fracture After Bipolar Hemiarthroplasty Using Shorter Femoral Stem and Standard Femoral Stem.,"Background
This randomized control study was designed to compare the clinical and radiological outcomes, including periprosthetic bone mineral density (BMD) changes, between the short and standard stems after using cementless hemiarthroplasty in elderly patients with femur neck fractures.
Materials and Methods
From January 2013 to May 2017, 151 patients (aged ≥ 65 years) underwent hemiarthroplasties due to femoral neck fractures. Patients were randomized into two groups; 77 patients in Group A implanting the short femoral stem and 74 patients in Group B implanting the standard femoral stem. Clinical and radiographic evaluations were performed in all patients.
Results
75 patients (40 patients in Group A and 35 patients in Group B) completed routine follow-up for a minimum of 2 years. The clinical outcomes, including ambulatory functions and thigh pain, were similar in both groups. All the femoral stems acquired radiologic stability. At postoperative one year, BMD values in Gruen zone (G) seven on the standard stem side were significantly lower than those on the short stem side ( P = 0.038). At the second year of follow-up, the BMD values of Group A in G1, G3, G4, and G7 were significantly greater than those of Group B ( P = 0.007, 0.032, 0.026, and P < 0.000, respectively).
Conclusions
Both the clinical outcomes and radiologic stability in both group demonstrated similar results in elderly patients with femoral neck fracture at the latest follow-up. In addition, the periprosthetic BMD of the short femoral stems demonstrated better periprosthetic bone preservation at a minimum of 2 years of follow-up.
Level of Evidences
Therapeutic Level II.",2020,"At postoperative one year, BMD values in Gruen zone (G) seven on the standard stem side were significantly lower than those on the short stem side ( P = 0.038).","['65\xa0years) underwent hemiarthroplasties due to femoral neck fractures', 'Elderly Patients with Femoral Neck Fracture', 'elderly patients with femoral neck fracture', 'From January 2013 to May 2017, 151 patients (aged\u2009≥', 'elderly patients with femur neck fractures']","['Bipolar Hemiarthroplasty Using Shorter Femoral Stem and Standard Femoral Stem', 'short femoral stem and 74 patients in Group B implanting the standard femoral stem', 'cementless hemiarthroplasty']","['periprosthetic bone preservation', 'radiologic stability', 'ambulatory functions and thigh pain', 'periprosthetic bone mineral density (BMD) changes', 'BMD values', 'periprosthetic BMD']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0241374', 'cui_str': 'Thigh pain'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0233149,"At postoperative one year, BMD values in Gruen zone (G) seven on the standard stem side were significantly lower than those on the short stem side ( P = 0.038).","[{'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Lim', 'Affiliation': 'Department of Orthopaedic Surgery, Inje University College of Medicine and Inje University Haeundae Paik Hospital, Busan, South Korea.'}, {'ForeName': 'Hyeong-Jun', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Department of Orthopaedic Surgery, Chung-Ang University College of Medicine and Chung-Ang University Hospital, 102 Heukseok-ro, Dongjak-gu, Seoul, 06973 South Korea.'}, {'ForeName': 'Young-Kyun', 'Initials': 'YK', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Yong-Chan', 'Initials': 'YC', 'LastName': 'Ha', 'Affiliation': 'Department of Orthopaedic Surgery, Chung-Ang University College of Medicine and Chung-Ang University Hospital, 102 Heukseok-ro, Dongjak-gu, Seoul, 06973 South Korea.'}, {'ForeName': 'Kyung-Hoi', 'Initials': 'KH', 'LastName': 'Koo', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University Bundang Hospital, Seongnam, South Korea.'}]",Indian journal of orthopaedics,['10.1007/s43465-020-00115-5']
1655,33133439,MyoRing Implantation with and without Corneal Collagen Crosslinking for the Management of Keratoconus.,"Purpose
To evaluate the safety and efficacy of femtosecond laser-assisted MyoRing implantation with concurrent corneal collagen crosslinking (CXL) compared to MyoRing alone for the treatment of progressive keratoconus.
Methods
A total of 60 patients were enrolled in this randomized controlled trial. The patients were randomly allocated into two groups. In the first group, MyoRing was implanted, while in the second, it was inserted in the corneal stroma using the same technique, along with simultaneous CXL. Visual, refractive, topographic, and abberometric outcomes were measured preoperatively and at every postoperative visit.
Results
Data of 47 patients were available at the end of the study; 28 in the MyoRing group and 19 in the MyoRing + CXL group. The mean uncorrected distance visual acuity (UDVA) improved from 0.79 ± 0.39 logMAR to 0.52 ± 0.31 logMAR (P < 0.05) in the MyoRing + CXL group and from 0.65 ± 0.38 logMAR to 0.62 ± 0.23 logMAR (P = 0.70) in the MyoRing group. CDVA changed from 0.33 ± 0.19 logMAR to 0.25 ± 0.16 logMAR (P = 0.10) in the MyoRing + CXL group and 0.32 ± 0.22 logMAR to 0.33 ± 0.17 logMAR (P > 0.50) in the MyoRing group. The mean keratometry (Km) decreased from 47.5 ± 2.7 D to 43.8 ± 3.2 D (P < 0.001) in the MyoRing group and 49.3 ± 3.4 D to 45.1 ± 3.0 D (P < 0.001) in the MyoRing + CXL group. Besides, horizontal coma was significantly lower in the MyoRing + CXL group (P = 0.022).
Conclusion
MyoRing insertion combined with CXL is a safe and effective method for the treatment of keratoconus. The visual and topographic outcomes were comparable to that for MyoRing insertion after 10 months; however, horizontal coma was significantly lower in the MyoRing + CXL group.",2020,"Besides, horizontal coma was significantly lower in the MyoRing + CXL group (P = 0.022).
","['Methods\n\n\nA total of 60 patients', '47 patients were available at the end of the study; 28 in the MyoRing group and 19 in the MyoRing + CXL group']","['femtosecond laser-assisted MyoRing implantation with concurrent corneal collagen crosslinking (CXL', 'MyoRing alone', 'MyoRing + CXL', 'MyoRing Implantation with and without Corneal Collagen Crosslinking', 'CXL']","['visual and topographic outcomes', 'CDVA', 'Visual, refractive, topographic, and abberometric outcomes', 'safety and efficacy', 'mean uncorrected distance visual acuity (UDVA', 'horizontal coma', 'mean keratometry (Km']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}]",60.0,0.0345937,"Besides, horizontal coma was significantly lower in the MyoRing + CXL group (P = 0.022).
","[{'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Mohammadpour', 'Affiliation': 'Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Masoumi', 'Affiliation': 'Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Dehghan', 'Affiliation': 'Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Nasser', 'Initials': 'MN', 'LastName': 'Hashemian', 'Affiliation': 'Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahab Addin', 'Initials': 'SA', 'LastName': 'Karami', 'Affiliation': 'Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Mahmoudi', 'Affiliation': 'Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of ophthalmic & vision research,['10.18502/jovr.v15i4.7790']
1656,33133563,"Beneficial health effects of Menaquinone-7 on body composition, glycemic indices, lipid profile, and endocrine markers in polycystic ovary syndrome patients.","Objective
The aim of this study was to investigate the effect of oral vitamin K2 (Menaquinone-7 [MK-7]) on clinical and biochemical parameters in polycystic ovary syndrome (PCOS) patients.
Methods
In this randomized, double-blind, placebo-controlled clinical trial, 84 PCOS patients were randomly assigned into the treatment (90 µg Menaquinone-7 daily for 8 weeks) and placebo groups. Insulin resistance, lipid profile, endocrine biomarkers, and body composition of the participants were measured before and after the intervention. This study was performed in Ghadir Mother & Child Hospital affiliated to Shiraz University of Medical Sciences, Shiraz, Iran.
Results
Menaquinone-7 supplementation, when compared to placebo, significantly decreased serum fasting insulin ( p = .002), homeostasis model of assessment insulin resistance ( p = .002), and homeostasis model of assessment β-cell function ( p = .02) in addition to a significant increase in quantitative insulin sensitivity check index ( p = .001). Also, MK-7 administration led to significant declines in serum triglyceride ( p = .003) and dihydrotestosterone (DHT; p = .03) levels, free androgen index ( p < .001), waist circumference ( p = .03), and body fat mass ( p < .001) as well as significant increases in skeletal muscle ( p < .001) and sex hormone binding globulin (SHBG, p < .001).
Conclusions
This study highlights the beneficial effects of MK-7 on insulin resistance, fat mass, skeletal muscle, and serum levels of triglyceride, DHT, and SHBG in PCOS patients. Therefore, it seems that MK-7 supplementation might be an appropriate additive treatment for PCOS patients.",2020,"Also, MK-7 administration led to significant declines in serum triglyceride ( p = .003) and dihydrotestosterone (DHT; p = .03) levels, free androgen index ( p < .001), waist circumference ( p = .03), and body fat mass (","['polycystic ovary syndrome patients', '84 PCOS patients', 'polycystic ovary syndrome (PCOS) patients', 'Ghadir Mother & Child Hospital affiliated to Shiraz University of Medical Sciences, Shiraz, Iran', 'PCOS patients']","['oral vitamin K2 (Menaquinone-7 [MK-7', 'placebo', 'Menaquinone-7', 'MK-7']","['homeostasis model of assessment insulin resistance', 'body fat mass ', 'skeletal muscle', 'Insulin resistance, lipid profile, endocrine biomarkers, and body composition', 'serum fasting insulin', 'waist circumference', 'insulin resistance, fat mass, skeletal muscle, and serum levels of triglyceride, DHT, and SHBG', 'quantitative insulin sensitivity check index', 'body composition, glycemic indices, lipid profile, and endocrine markers', 'sex hormone binding globulin', 'free androgen index', 'homeostasis model of assessment β-cell function', 'serum triglyceride']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0078382', 'cui_str': 'vitamin MK 7'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0038148', 'cui_str': 'androstanolone'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}]",84.0,0.390335,"Also, MK-7 administration led to significant declines in serum triglyceride ( p = .003) and dihydrotestosterone (DHT; p = .03) levels, free androgen index ( p < .001), waist circumference ( p = .03), and body fat mass (","[{'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Tarkesh', 'Affiliation': 'Clinical Nutrition Department School of Nutrition and Food Sciences Shiraz University of Medical Sciences Shiraz Iran.'}, {'ForeName': 'Bahia', 'Initials': 'B', 'LastName': 'Namavar Jahromi', 'Affiliation': 'Infertility Research Center Shiraz University of Medical Sciences Shiraz Iran.'}, {'ForeName': 'Najmeh', 'Initials': 'N', 'LastName': 'Hejazi', 'Affiliation': 'Nutrition Research Center Department of Clinical Nutrition School of Nutrition and Food Sciences Shiraz University of Medical Sciences Shiraz Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Tabatabaee', 'Affiliation': 'Department of Epidemiology School of Health Shiraz University of Medical Sciences Shiraz Iran.'}]",Food science & nutrition,['10.1002/fsn3.1837']
1657,33137986,Influence of Transcranial Direct Current Stimulation on Psychomotor Symptoms in Major Depression.,"BACKGROUND
Transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (dlPFC) might be a promising treatment strategy for depression. As disturbances in psychomotor activity are one of the key features of unipolar depression are, we aimed to evaluate the behavioral effects of ten tDCS sessions over a 5-day period on psychomotor retardation in depressed patients.
METHODS
Twenty-three treatment-resistant depressed patients received either active or sham anodal tDCS to the left dorsolateral prefrontal cortex (2 mA, 10 sessions over 1 week). Psychomotor functioning was registered by means of observer ratings (Salpêtrière Retardation Rating Scale-SRRS) and objective measures (kinematical analysis of movements, automatic imitation).
RESULTS
tDCS sessions resulted in improvements on SRRS scores, although active tDCS was not significantly superior to sham tDCS on the kinematical parameters. Furthermore, no general additional antidepressant effect of tDCS was observed. The relatively small sample size and the short periods of observation should be considered when interpreting these results.
CONCLUSION
tDCS did not induce a clinically relevant effect on psychomotor function in active and sham stimulation groups.",2020,"RESULTS
tDCS sessions resulted in improvements on SRRS scores, although active tDCS was not significantly superior to sham tDCS on the kinematical parameters.","['Twenty-three treatment-resistant depressed patients received either', 'Psychomotor Symptoms in Major Depression']","['active or sham anodal tDCS', 'Transcranial direct current stimulation (tDCS', 'Transcranial Direct Current Stimulation', 'tDCS']","['SRRS scores', 'Psychomotor functioning', 'observer ratings (Salpêtrière Retardation Rating Scale-SRRS) and objective measures (kinematical analysis of movements, automatic imitation', 'psychomotor function']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0574526', 'cui_str': 'Serer language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025362', 'cui_str': 'Mental retardation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0033923', 'cui_str': 'Psychomotor Performance'}]",23.0,0.0244753,"RESULTS
tDCS sessions resulted in improvements on SRRS scores, although active tDCS was not significantly superior to sham tDCS on the kinematical parameters.","[{'ForeName': 'Djamila', 'Initials': 'D', 'LastName': 'Bennabi', 'Affiliation': ""Service de Psychiatrie de l'Adulte, Centre Hospitalier Universitaire de Besançon, 25030 Besançon CEDEX, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Carvalho', 'Affiliation': ""Service de Psychiatrie de l'Adulte, Centre Hospitalier Universitaire de Besançon, 25030 Besançon CEDEX, France.""}, {'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Bisio', 'Affiliation': 'Department of Experimental Medicine, Section of Human Physiology and Centro Polifunzionale di Scienze Motorie, University of Genoa, Viale Benedetto XV 3, 16132 Genoa, Italy.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Teti Mayer', 'Affiliation': ""Service de Psychiatrie de l'Adulte, Centre Hospitalier Universitaire de Besançon, 25030 Besançon CEDEX, France.""}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Pozzo', 'Affiliation': 'INSERM U1093-Cognition, Action et Plasticité Sensorimotrice, Université de Bourgogne Franche-Comté, 21078 Dijon, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Haffen', 'Affiliation': ""Service de Psychiatrie de l'Adulte, Centre Hospitalier Universitaire de Besançon, 25030 Besançon CEDEX, France.""}]",Brain sciences,['10.3390/brainsci10110792']
1658,33137993,High-Intensity Interval Training Improves Cognitive Flexibility in Older Adults.,"Introduction: Regular aerobic exercise is associated with better executive function in older adults. It is unclear if high-intensity-interval-training (HIIT) elicits moderate-intensity continuous training (MICT) or resistance training (RT). We hypothesized that HIIT would augment executive function more than MICT and RT. Methods: Sixty-nine older adults (age: 68 ± 7 years) performed six weeks (three days/week) of HIIT (2 × 20 min bouts alternating between 15 s intervals at 100% of peak power output (PPO) and passive recovery (0% PPO); n = 24), MICT (34 min at 60% PPO; n = 19), or whole-body RT (eight exercise superior improvements in executive function of older adults than moderate-intensity-continuous-training, 2 × 10 repetitions; n = 26). Cardiorespiratory fitness (i.e., V˙O2max) and executive function were assessed before and after each intervention via a progressive maximal cycle ergometer protocol and the Stroop Task, respectively. Results: The V˙O2max findings revealed a significant group by time interaction ( p = 0.001) in which all groups improved following training, but HIIT and MICT improved more than RT. From pre- to post-training, no interaction in the naming condition of the Stroop Task was observed ( p > 0.10). However, interaction from pre- to post-training by group was observed, and only the HIIT group exhibited a faster reaction time (from 1250 ± 50 to 1100 ± 50 ms; p < 0.001) in switching (cognitive flexibility). Conclusion: Despite similar improvements in cardiorespiratory fitness, HIIT, but not MICT nor RT, enhanced cognitive flexibility in older adults. Exercise programs should consider using HIIT protocols in an effort to combat cognitive decline in older adults.",2020,"Despite similar improvements in cardiorespiratory fitness, HIIT, but not MICT nor RT, enhanced cognitive flexibility in older adults.","['older adults', 'Sixty-nine older adults (age: 68 ± 7 years', 'Older Adults']","['MICT', 'interval-training (HIIT) elicits moderate-intensity continuous training (MICT) or resistance training (RT', 'High-Intensity Interval Training', 'whole-body RT (eight exercise superior improvements in executive function of older adults than moderate-intensity-continuous-training', 'Regular aerobic exercise']","['Cognitive Flexibility', 'time interaction', 'faster reaction time', 'Cardiorespiratory fitness (i.e., V˙O2max) and executive function', 'executive function', 'cognitive flexibility']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",69.0,0.0210712,"Despite similar improvements in cardiorespiratory fitness, HIIT, but not MICT nor RT, enhanced cognitive flexibility in older adults.","[{'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Mekari', 'Affiliation': 'School of Kinesiology, Acadia University, 550. Main Street, Wolfville, NS B4P 2R6, Canada.'}, {'ForeName': 'Heather F', 'Initials': 'HF', 'LastName': 'Neyedli', 'Affiliation': 'Division of Kinesiology, Faculty of Health, School of Health and Human Performance, Dalhousie University, Halifax, NS B3H 1T8, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fraser', 'Affiliation': 'Interdisciplinary School of Health Sciences, University of Ottawa, Ottawa, ON K1N 74K, Canada.'}, {'ForeName': 'Myles W', 'Initials': 'MW', 'LastName': ""O'Brien"", 'Affiliation': 'Division of Kinesiology, Faculty of Health, School of Health and Human Performance, Dalhousie University, Halifax, NS B3H 1T8, Canada.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Martins', 'Affiliation': 'School of Kinesiology, Acadia University, 550. Main Street, Wolfville, NS B4P 2R6, Canada.'}, {'ForeName': 'Kailey', 'Initials': 'K', 'LastName': 'Evans', 'Affiliation': 'School of Kinesiology, Acadia University, 550. Main Street, Wolfville, NS B4P 2R6, Canada.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Earle', 'Affiliation': 'School of Kinesiology, Acadia University, 550. Main Street, Wolfville, NS B4P 2R6, Canada.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Aucoin', 'Affiliation': 'School of Kinesiology, Acadia University, 550. Main Street, Wolfville, NS B4P 2R6, Canada.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Chiekwe', 'Affiliation': 'School of Kinesiology, Acadia University, 550. Main Street, Wolfville, NS B4P 2R6, Canada.'}, {'ForeName': 'Quinn', 'Initials': 'Q', 'LastName': 'Hollohan', 'Affiliation': 'School of Kinesiology, Acadia University, 550. Main Street, Wolfville, NS B4P 2R6, Canada.'}, {'ForeName': 'Derek S', 'Initials': 'DS', 'LastName': 'Kimmerly', 'Affiliation': 'Division of Kinesiology, Faculty of Health, School of Health and Human Performance, Dalhousie University, Halifax, NS B3H 1T8, Canada.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dupuy', 'Affiliation': 'Laboratory MOVE (EA 6314), Faculty of Sport Sciences, University of Poitiers, 86000 Poitiers, France.'}]",Brain sciences,['10.3390/brainsci10110796']
1659,33137995,Antimicrobial Capacity and Surface Alterations Using Photodynamic Therapy and Light Activated Disinfection on Polymer-Infiltrated Ceramic Material Contaminated with Periodontal Bacteria.,"This study determined the antimicrobial efficiency of light-activated disinfection (LAD) and photodynamic therapy (PDT) on polymer-infiltrated ceramic network (PICN) material contaminated with three periodontal bacteria and explored if PDT and LAD cause PICN surface alterations. Sixty PICN discs were contaminated with Tannerella forsythia , Porphyromonas gingivalis , and Treponema denticola and randomly divided into five groups ( n = 12 samples/each) according to the treatment groups: Group PDT-PDT (630 ± 10 nm diode laser) with methylene blue; Group DL-808 nm diode laser in contact mode without photosensitizer; Group MB-methylene blue without light application; Group CHX-0.12% chlorhexidine digluconate solution and; Group NT-no treatment. Each disc was then placed in tubes containing phosphate buffered saline (PBS) and vortexed for 30 s to remove the remaining bacteria from the discs. A total of 10× serial dilutions were performed followed by plating of 30 μL of suspension on Brucella agar plates. The colony forming units (CFU) were calculated after 72 h. PICN discs with the attached biofilms were used for confocal microscopy investigation for live/dead bacterial viability. A random single sample from each group was selected to study the bacterial adherence and topographical alterations on PICN discs under scanning electron microscope (SEM). The PDT group showed higher reduction for each bacterial species and total counts of bacteria assessed followed by the DL group ( p < 0.05). When compared with MB group, the two laser groups were significantly superior ( p < 0.05). The MB group did not show significant differences for any bacteria when compared to NT. The bacteria with the CHX group and DL groups appeared dead with few areas of surviving green stained bacteria. The PDT group showed the highest dead cell count ( p < 0.05). PDT and DL groups indicate no significant changes on the surface compared to the sterile PICN discs on visual assessment. Photodynamic therapy produced superior periodontal bacteria reduction over the surface of PICN surface. PDT group showed higher reduction for each bacterial species and total counts of bacteria assessed followed by the DL group. Both PDT and DL treatment strategies are effective without producing surface alterations on PICN.",2020,The PDT group showed higher reduction for each bacterial species and total counts of bacteria assessed followed by the DL group ( p < 0.05).,[],"['Photodynamic Therapy and Light Activated Disinfection', 'phosphate buffered saline (PBS', 'light-activated disinfection (LAD) and photodynamic therapy (PDT', 'PDT', 'Group PDT-PDT (630 ± 10 nm diode laser) with methylene blue; Group DL-808 nm diode laser in contact mode without photosensitizer; Group MB-methylene blue without light application; Group CHX-0.12% chlorhexidine digluconate solution and; Group NT-no treatment', 'CHX', 'Photodynamic therapy']","['superior periodontal bacteria reduction', 'visual assessment', 'highest dead cell count', 'bacterial species and total counts of bacteria']",[],"[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0033770', 'cui_str': 'Prune belly syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0162713', 'cui_str': 'Photosensitizing agent'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",,0.014247,The PDT group showed higher reduction for each bacterial species and total counts of bacteria assessed followed by the DL group ( p < 0.05).,"[{'ForeName': 'Elzahraa', 'Initials': 'E', 'LastName': 'Eldwakhly', 'Affiliation': 'Department of Fixed Prosthodontics, Faculty of Dentistry, Cairo University, Cairo 12613, Egypt.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Saadaldin', 'Affiliation': 'Division of Prosthodontics, Schulich School of Medicine and Dentistry, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Alhanoof', 'Initials': 'A', 'LastName': 'Aldegheishem', 'Affiliation': 'Clinical Dental Science Department, College of Dentistry, Princess Nourah Bint Abdulrahman University, P.O. Box 84428, Riyadh 11564, Saudi Arabia.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Salah Mostafa', 'Affiliation': 'Department of Medical Microbiology and Immunology, Faculty of Medicine, Cairo University, Cairo 12613, Egypt.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Soliman', 'Affiliation': 'Clinical Dental Science Department, College of Dentistry, Princess Nourah Bint Abdulrahman University, P.O. Box 84428, Riyadh 11564, Saudi Arabia.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph13110350']
1660,33138061,"Whey Protein Drink Ingestion before Breakfast Suppressed Energy Intake at Breakfast and Lunch, but Not during Dinner, and Was Less Suppressed in Healthy Older than Younger Men.","Ageing is associated with changes in feeding behavior. We have reported that there is suppression of energy intake three hours after whey protein drink ingestion in young, but not older, men. This study aimed to determine these effects over a time period of 9 h. Fifteen younger (27 ± 1 years, 25.8 ± 0.7 kg/m 2 ) and 15 older (75 ± 2 years, 26.6 ± 0.8 kg/m 2 ) healthy men were studied on three occasions on which they received, in a randomized order, a 30 g/120 kcal, 70 g/280 kcal whey-protein, or control (~2 kcal) drink. Ad-libitum energy intake (sum of breakfast, lunch, and dinner) was suppressed in a protein load responsive fashion ( P = 0.001). Suppression was minimal at breakfast, substantial at lunch (~-16%, P = 0.001), no longer present by dinner, and was less in older than younger men (-3 ± 4% vs. -8 ± 4%, P = 0.027). Cumulative protein intake was increased in the younger and older men (+20% and +42%, P < 0.001). Visual analogue scale ratings of fullness were higher and desire to eat and prospective food consumption were lower after protein vs. control, and these effects were smaller in older vs. younger men (interaction effect P < 0.05). These findings support the use of whey-protein drink supplements in older people who aim to increase their protein intake without decreasing their overall energy intake.",2020,"Suppression was minimal at breakfast, substantial at lunch (~-16%, P = 0.001), no longer present by dinner, and was less in older than younger men (-3 ± 4% vs. -8 ± 4%, P = 0.027).","['9 h. Fifteen younger (27 ± 1 years, 25.8 ± 0.7 kg/m 2 ) and 15 older (75 ± 2 years, 26.6 ± 0.8 kg/m 2 ) healthy men', 'Healthy Older than Younger Men', 'older people']",[],"['desire to eat and prospective food consumption', 'Suppression', 'Cumulative protein intake', 'Visual analogue scale ratings of fullness']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}]",,0.0421774,"Suppression was minimal at breakfast, substantial at lunch (~-16%, P = 0.001), no longer present by dinner, and was less in older than younger men (-3 ± 4% vs. -8 ± 4%, P = 0.027).","[{'ForeName': 'Avneet', 'Initials': 'A', 'LastName': 'Oberoi', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, Adelaide, SA 5000, South-Australia, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Giezenaar', 'Affiliation': 'Riddet Institute, Massey University, Palmerston North 9430, New Zealand.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Clames', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, Adelaide, SA 5000, South-Australia, Australia.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Bøhler', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, Adelaide, SA 5000, South-Australia, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, Adelaide, SA 5000, South-Australia, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, Adelaide, SA 5000, South-Australia, Australia.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, Adelaide, SA 5000, South-Australia, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chapman', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, Adelaide, SA 5000, South-Australia, Australia.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Soenen', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, Adelaide, SA 5000, South-Australia, Australia.'}]",Nutrients,['10.3390/nu12113318']
1661,33138680,Efficacy of chitosan-based chewing gum on reducing salivary S. mutans counts and salivary pH: a randomised clinical trial.,"OBJECTIVE
To determine chitosan-based chewing gum role on reducing salivary S. mutans counts and salivary pH.
MATERIALS AND METHODS
The present double-blind randomised clinical trial with the trial registration number of IRCT20190724044319N1 was conducted on 36 dental students. The volunteers were, randomly, divided into two groups ( n = 18) including: G1: intervention group (chitosan chewing gum) and G2: control group (placebo chewing gum). Each participant was given eight pieces of the chewing gum, and was asked to chew each gum piece for 5 min and this was repeated for eight times. Their Saliva was collected before and after chewing gums and the number of S. mutans colonies and salivary pH were determined. Data were analysed using SPSS (ver.21) and independent student t test. p Value less than .05 was set as significant.
RESULTS
There was significant difference between two groups for the number of salivary S. mutans colonies ( 3 . 31 * 10 5 in the intervention group compared to 13.94 * 10 5 in the Control group) ( p < .001). The salivary pH evaluation showed that salivary pH mean value in intervention group was not significant in compared with control group ( p = .17). However, the chitosan chewing gum led to an increase in salivary pH by 0.17, which was statistically significant ( p = .01).
CONCLUSION
Results of this study showed that chitosan chewing gum has a positive effect on the reduction of numbers of salivary S. mutans colonies but had no considerable effect on the increase of salivary pH.",2020,"However, the chitosan chewing gum led to an increase in salivary pH by 0.17, which was statistically significant ( p = .01).
","['31', '36 dental students']","['G1: intervention group (chitosan chewing gum) and G2: control group (placebo chewing gum', 'chitosan-based chewing gum']","['salivary pH', 'salivary pH mean value']","[{'cui': 'C0038493', 'cui_str': 'Dental Student'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",36.0,0.0428484,"However, the chitosan chewing gum led to an increase in salivary pH by 0.17, which was statistically significant ( p = .01).
","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Khamverdi', 'Affiliation': 'Department of Operative Dentistry, School of dentistry, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Farhadian', 'Affiliation': 'School of dentistry, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Khazaei', 'Affiliation': 'Research Center for Health Sciences, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Adabi', 'Affiliation': 'Brucellosis Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Acta odontologica Scandinavica,['10.1080/00016357.2020.1836392']
1662,33133875,Can Continuous Local Anesthetic Infusion After Median Sternotomy Reduce Opioid Use?,"Introduction Effective treatment of postoperative pain due to median sternotomy speeds up hemodynamic healing of patients. For this purpose, opioids with a wide range of side effects are widely used at high doses. The aim of this study is to investigate the effect of continuous local anesthetic (bupivacaine) infusion on opioid use on cardiac surgery patients undergoing median sternotomy. Methods A total of 215 patients undergoing isolated coronary artery bypass grafting surgery were included in the study; and 105 patients who underwent parasternal continuous local anesthetic infusion (0.5% bupivacaine at 4 mL/h, for 48h) were determined as local anesthesia group and other patients were as control group. The primary outcomes evaluated between the groups in the postoperative period were pain scores (VAS: Visual Analogic Score, PHHPS: Prince Henry Hospital Pain Score) and the number of opioids used. Secondary outcomes were mechanical ventilation time, intensive care unit and hospital stay duration, development of atrial fibrillation and atelectasis. Results Postoperative pain was found to be significantly lower in the local anesthesia group compared to the control group (VAS: 3 ± 1.9 vs 6.4 ± 1.8, p < 0.001; PHHPS: 0.9 ± 0.8 vs 1.62 ± 0.82, p < 0.001). As a result of this, opioid drug use was significantly lower in the local anesthesia group compared to the control group (0 (0 - 4) vs 1 (0 - 8), p < 0.001). Mechanical ventilation time, intensive care unit and hospital stay duration, and development of atelectasis were significantly lower in the local anesthesia group. In terms of the development of atrial fibrillation, no significant difference was found between the groups. Conclusion Parasternal continuous local anesthetic infusion reduces postoperative opioid use and speeds up hemodynamic healing by preventing possible side effects of opioids. It is a simple and effective method in the treatment of postoperative pain due to median sternotomy.",2020,Conclusion Parasternal continuous local anesthetic infusion reduces postoperative opioid use and speeds up hemodynamic healing by preventing possible side effects of opioids.,"['215 patients undergoing isolated coronary artery bypass grafting surgery were included in the study; and 105 patients who underwent', 'postoperative pain due to median sternotomy speeds up hemodynamic healing of patients', 'cardiac surgery patients undergoing median sternotomy']","['parasternal continuous local anesthetic infusion (0.5% bupivacaine', 'continuous local anesthetic (bupivacaine']","['mechanical ventilation time, intensive care unit and hospital stay duration, development of atrial fibrillation and atelectasis', 'pain scores (VAS: Visual Analogic Score, PHHPS', 'Prince Henry Hospital Pain Score', 'Postoperative pain', 'Mechanical ventilation time, intensive care unit and hospital stay duration, and development of atelectasis']","[{'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0442146', 'cui_str': 'Parasternal'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582517', 'cui_str': 'henry'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",215.0,0.0314142,Conclusion Parasternal continuous local anesthetic infusion reduces postoperative opioid use and speeds up hemodynamic healing by preventing possible side effects of opioids.,"[{'ForeName': 'Arda Aybars', 'Initials': 'AA', 'LastName': 'Pala', 'Affiliation': 'Cardiovascular Surgery, Adıyaman Training and Research Hospital, Adıyaman, TUR.'}, {'ForeName': 'Yusuf Salim', 'Initials': 'YS', 'LastName': 'Urcun', 'Affiliation': 'Cardiovascular Surgery, Adıyaman Training and Research Hospital, Adıyaman, TUR.'}, {'ForeName': 'Ömer Faruk', 'Initials': 'ÖF', 'LastName': 'Çiçek', 'Affiliation': 'Cardiovascular Surgery, Selçuk University Faculty of Medicine, Konya, TUR.'}, {'ForeName': 'Serpil', 'Initials': 'S', 'LastName': 'Şahin', 'Affiliation': 'Cardiovascular Surgery, Canakkale Onsekiz Mart University Faculty of Medicine, Canakkale, TUR.'}]",Cureus,['10.7759/cureus.10711']
1663,33134106,Early clinical outcome and learning curve following unilateral primary total knee arthroplasty after introduction of a novel total knee arthroplasty system.,"BACKGROUND
New implants for total knee arthroplasty (TKA) are continuously introduced with the proposed benefit of increased performance and improved outcome. Little information exists on how the introduction of a novel arthroplasty implant affects the perioperative and surgical outcome immediately after implementation.
AIM
To investigate how surgery-related factors and implant positioning were affected by the introduction of a novel TKA system.
METHODS
A novel TKA system was introduced at our institution on 30th November 2015. Seventy-five TKAs performed with the Persona TKA immediately following its introduction by 3 different surgeons (25 TKAs/surgeon) were identified as the Introduction Group. Moreover, the latest 25 TKAs performed by each surgeon prior to introduction of the Persona TKA were identified as the Control Group. A Follow-up Group of 25 TKAs/surgeon was identified starting 1-year after the end of the introduction period. Demographics, surgery-related factors and alignment data were recorded, and intergroup differences compared.
RESULTS
Following introduction of the novel implant, Persona TKA was utilized in 69% (71%), 53% (54%), and 45% (75%) of primary TKA procedures by the three surgeons, respectively (Follow-up Group). Mean surgery time was increased by 28% ( P < 0.0001) and mean intra-operative blood loss by 25% ( P = 0.002) in the Introduction Group, while only the mean surgery time was increased in the Follow-up Group by 18% ( P < 0.0001). Overall alignment was similar between the groups apart from femoral flexion (FF) and tibial slope (TS). The number of FF outliers was reduced in the Introduction Group with a more pronounced decrease in the Follow-up Group.
CONCLUSION
Introduction of the new TKA implant increased surgical time and intraoperative blood loss immediately after its introduction. These differences diminished one year after introduction of the new implant. Fewer outliers with respect to FF and TS were seen when using the novel TKA implant. Further studies are needed to investigate if these differences persist over time and correlate with patient reported outcomes.",2020,"Mean surgery time was increased by 28% ( P < 0.0001) and mean intra-operative blood loss by 25% ( P = 0.002) in the Introduction Group, while only the mean surgery time was increased in the Follow-up Group by 18% ( P < 0.0001).",['total knee arthroplasty (TKA'],['unilateral primary total knee arthroplasty after introduction of a novel total knee arthroplasty system'],"['mean surgery time', 'mean intra-operative blood loss', 'surgical time and intraoperative blood loss', 'Mean surgery time', 'femoral flexion (FF) and tibial slope (TS', 'number of FF outliers']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.0275445,"Mean surgery time was increased by 28% ( P < 0.0001) and mean intra-operative blood loss by 25% ( P = 0.002) in the Introduction Group, while only the mean surgery time was increased in the Follow-up Group by 18% ( P < 0.0001).","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Omari', 'Affiliation': 'Department of Orthopedic Surgery, Copenhagen University Hvidovre Hospital, Copenhagen 2650, Denmark. adam.omari.01@regionh.dk.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Troelsen', 'Affiliation': 'Department of Orthopedic Surgery, Copenhagen University Hospital Hvidovre, Copenhagen 2650, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Husted', 'Affiliation': 'Department of Orthopedic Surgery, Copenhagen University Hospital Hvidovre, Copenhagen 2650, Denmark.'}, {'ForeName': 'Christian Skovgaard', 'Initials': 'CS', 'LastName': 'Nielsen', 'Affiliation': 'Department of Orthopedic Surgery, Copenhagen University Hospital Hvidovre, Copenhagen 2650, Denmark.'}, {'ForeName': 'Kirill', 'Initials': 'K', 'LastName': 'Gromov', 'Affiliation': 'Department of Orthopedic Surgery, Copenhagen University Hospital Hvidovre, Copenhagen 2650, Denmark.'}]",World journal of orthopedics,['10.5312/wjo.v11.i10.431']
1664,33134107,"Highly cross-linked versus conventional polyethylene inserts in total hip arthroplasty, a five-year Roentgen stereophotogrammetric analysis randomised controlled trial.","BACKGROUND
Polyethylene (PE) particles produced by wear of the acetabular insert are thought to cause osteolysis and thereby aseptic loosening of the implant in total hip arthroplasty (THA). As highly cross-linked polyethylene (HXLPE) is presumed to give lower wear rates, in vivo studies are needed to confirm this.
AIM
To compare the wear of REXPOL, a HXPLE, with conventional PE within the first five years after implantation using Roentgen stereophotogrammetric analysis (RSA).
METHODS
Patients were randomised to receive either a HXLPE (REXPOL) or a conventional PE insert during primary THA. RSA images were obtained directly postoperative and after 6 wk, 12 wk, 6 mo, 12 mo, 24 mo and five years. Functional outcomes were assessed using the Hip Injury and Osteoarthritis Outcome Score and Harris Hip Score at baseline and five years after surgery.
RESULTS
The HXLPE (REXPOL) showed less wear in the latero-medial direction. Significant wear rates of conventional PE were seen in the latero-medial and center-proximal direction and in volume and corrected volume, whereas the REXPOL did not show these outcomes over time. Improvement from baseline in functional outcome did not significantly differ.
CONCLUSION
Total 3D wear is less in THAs inserted with a REXPOL inlay than a conventional PE inlay after five years. This study confirms, for the first, that the REXPOL HXLPE inlay is preferred to standard PE.",2020,"Significant wear rates of conventional PE were seen in the latero-medial and center-proximal direction and in volume and corrected volume, whereas the REXPOL did not show these outcomes over time.",['Patients'],"['conventional PE insert during primary THA', 'HXLPE (REXPOL']","['Significant wear rates of conventional PE', 'Hip Injury and Osteoarthritis Outcome Score and Harris Hip Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0281865', 'cui_str': 'Injury of hip region'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}]",,0.137831,"Significant wear rates of conventional PE were seen in the latero-medial and center-proximal direction and in volume and corrected volume, whereas the REXPOL did not show these outcomes over time.","[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'van Loon', 'Affiliation': 'Department of Orthopaedic Surgery, Xpert Orthopedie Amsterdam/Specialized Center of Orthopedic Research and Education, Amsterdam 1101EA, Netherlands.'}, {'ForeName': 'Daniël', 'Initials': 'D', 'LastName': 'Hoornenborg', 'Affiliation': 'Department of Orthopaedic Surgery, Xpert Orthopedie Amsterdam/Specialized Center of Orthopedic Research and Education, Amsterdam 1101EA, Netherlands.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Sierevelt', 'Affiliation': 'Department of Orthopaedic Surgery, Xpert Orthopedie Amsterdam/Specialized Center of Orthopedic Research and Education, Amsterdam 1101EA, Netherlands.'}, {'ForeName': 'Kim Tm', 'Initials': 'KT', 'LastName': 'Opdam', 'Affiliation': 'Department of Orthopaedic Surgery, Amsterdam University Medical Centres, Location Academic Medical Center, Amsterdam 1105AZ, Netherlands.'}, {'ForeName': 'Gino Mmj', 'Initials': 'GM', 'LastName': 'Kerkhoffs', 'Affiliation': 'Department of Orthopaedic Surgery, Amsterdam University Medical Centres, Location Academic Medical Center, Amsterdam 1105AZ, Netherlands.'}, {'ForeName': 'Daniël', 'Initials': 'D', 'LastName': 'Haverkamp', 'Affiliation': 'Department of Orthopaedic Surgery, Xpert Orthopedie Amsterdam/Specialized Center of Orthopedic Research and Education, Amsterdam 1101EA, Netherlands. d.haverkamp@xpertorthopedie.nl.'}]",World journal of orthopedics,['10.5312/wjo.v11.i10.442']
1665,33134132,"Effectiveness of novel herbal dentifrice in control of plaque, gingivitis, and halitosis - Randomized controlled trial.","Background and aim
Plaque is a common etiological factor for common oral conditions like gingivitis, periodontitis, dental caries and halitosis. We aimed to evaluate the efficacy of a novel herbal dentifrice in control of plaque, gingivitis, and halitosis in comparison to control dentifrice.
Experimental procedure
We conducted a randomized controlled, single center, double-blinded parallel arm clinical trial. Participants were randomly distributed with commercially available herbal dentifrice or control dentifrice. Assessments of plaque, gingivitis, halitosis, unstimulated saliva pH were done at baseline and at one month by a trained and calibrated periodontist. All the participants were given new toothbrushes one week before the start of the study. They were asked to brush with the designated dentifrices for 2-4 min, twice daily for one month.
Results and conclusion
A total of 79 participants were recruited for this study, out of which 75 participants completed the follow-up. Inter-group comparisons of all the variables at baseline showed no significant differences in the mean plaque index, gingival index, halitosis and pH between test and control groups respectively. Intra-group comparisons showed a significant decrease in mean plaque, gingival and halitosis at follow-up than at baseline in both test and control groups. No significant differences between test and control groups were seen in the mean plaque index (P = 0.792), gingival index (P = 0.292), halitosis (P = 0.266), pH (P = 0.742) at follow-up after adjusting the respective baseline scores. The novel herbal dentifrice could be a suitable alternative for the control of plaque, gingivitis, and halitosis.",2020,"No significant differences between test and control groups were seen in the mean plaque index (P = 0.792), gingival index (P = 0.292), halitosis (P = 0.266), pH (P = 0.742) at follow-up after adjusting the respective baseline scores.","['A total of 79 participants were recruited for this study, out of which 75 participants completed the follow-up']","['novel herbal dentifrice', 'herbal dentifrice or control dentifrice']","['Assessments of plaque, gingivitis, halitosis, unstimulated saliva pH', 'mean plaque, gingival and halitosis', 'mean plaque index', 'gingival index', 'mean plaque index, gingival index, halitosis and pH']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0018520', 'cui_str': 'Breath smells unpleasant'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}]",79.0,0.112159,"No significant differences between test and control groups were seen in the mean plaque index (P = 0.792), gingival index (P = 0.292), halitosis (P = 0.266), pH (P = 0.742) at follow-up after adjusting the respective baseline scores.","[{'ForeName': 'Kalyana-Chakravarthy', 'Initials': 'KC', 'LastName': 'Pentapati', 'Affiliation': 'Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Meena Anand', 'Initials': 'MA', 'LastName': 'Kukkamalla', 'Affiliation': 'Department of Periodontology, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Siddiq', 'Affiliation': 'Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Neeraja', 'Initials': 'N', 'LastName': 'Sabnis', 'Affiliation': 'Manager (R and D for Cosmetics), Sriveda Sattva Pvt. Ltd, Bangalore, India.'}]",Journal of traditional and complementary medicine,['10.1016/j.jtcme.2019.06.006']
1666,33134140,A Clinical Trial on the Effects of Different Regimens of Phenylephrine on Maternal Hemodynamic After Spinal Anesthesia for Cesarean Section.,"Background
Phenylephrine is used to prevent and treat hypotension during spinal anesthesia for cesarean delivery.
Objectives
The present study aims to investigate the effects of different regimens of phenylephrine on blood pressure of candidates for the cesarean section.
Methods
In this double-blind, randomized clinical trial, a total of 120 candidates of elective cesarean delivery under spinal anesthesia was randomly categorized into three groups. Groups 1, 2, and 3 received bolus and prophylactic saline (control group), prophylactic bolus phenylephrine (100 µg), and prophylactic phenylephrine infusion (50 µg/min), respectively. The incidence of hypotension, maternal hemodynamics, hypertension, rescue phenylephrine dose, nausea, and vomit were compared between the groups.
Results
In all the three groups, the incidence of nausea and vomit, bradycardia, hypertension, and neonatal Apgar score were not statistically different (P > 0.05). However, the adjuvant phenylephrine dose requirement was remarkably different. Moreover, the mean systolic blood pressure differed significantly in the second and 7th minutes after the spinal block (P < 0.05). 35% in the first group, 15% in the second group, and 2.5% in the third group had hypotension (P = 0.001). Apart from the first measurement after spinal anesthesia, the mean heart rate showed no significant difference between the groups.
Conclusions
The use of prophylactic phenylephrine infusion is recommended to control the optimal blood pressure in parturients undergoing cesarean section after spinal anesthesia.",2020,"In all the three groups, the incidence of nausea and vomit, bradycardia, hypertension, and neonatal Apgar score were not statistically different (P > 0.05).","['parturients undergoing cesarean section after spinal anesthesia', 'After Spinal Anesthesia for Cesarean Section', '120 candidates of elective cesarean delivery under spinal anesthesia']","['Phenylephrine', 'prophylactic phenylephrine', 'phenylephrine', 'prophylactic saline (control group), prophylactic bolus phenylephrine (100 µg), and prophylactic phenylephrine infusion']","['hypotension', 'mean systolic blood pressure', 'incidence of nausea and vomit, bradycardia, hypertension, and neonatal Apgar score', 'blood pressure', 'mean heart rate', 'Maternal Hemodynamic', 'incidence of hypotension, maternal hemodynamics, hypertension, rescue phenylephrine dose, nausea, and vomit']","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",120.0,0.0780912,"In all the three groups, the incidence of nausea and vomit, bradycardia, hypertension, and neonatal Apgar score were not statistically different (P > 0.05).","[{'ForeName': 'Mahshid', 'Initials': 'M', 'LastName': 'Nikooseresht', 'Affiliation': 'Department of Anesthesiology, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Seifrabiei', 'Affiliation': 'Department of Community Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Pouran', 'Initials': 'P', 'LastName': 'Hajian', 'Affiliation': 'Department of Anesthesiology, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Shadab', 'Initials': 'S', 'LastName': 'Khamooshi', 'Affiliation': 'Department of Anesthesiology, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Anesthesiology and pain medicine,['10.5812/aapm.58048']
1667,33134142,Effect of General Versus Spinal Anesthesia on Postoperative Delirium and Early Cognitive Dysfunction in Elderly Patients.,"Background
Postoperative cognitive dysfunction (POCD) and delirium are common in the elderly patients, given the controversial results of previous studies about the impact of anesthesia type on the occurrence of these complications.
Objectives
This study was planned to compare the effects of general and spinal anesthesia on the prevalence of POCD and delirium.
Methods
A single-blind non-randomized clinical trial. Setting was in two academic hospitals. Ninety-four patients over 50 years old scheduled for hip fracture fixation. Patients were divided into two groups to receive either general (GA) or spinal (SA) anesthesia. Both Mini-Mental State examination (MMSE) and Wechsler tests were used before the operation and 3 times postoperatively to assess the cognitive function and detect early POCD. The DSM-IV criteria were also used for the diagnosis of delirium. The incidence of delirium and POCD and their precipitating factors were compared between the two groups.
Results
Ninety-four patients with a mean age of 67.12 years were studied. The overall prevalence of POCD and delirium was 17.02%; however, it was significantly higher in the GA group rather than the SA group, 29.7%, and 4.25%, respectively (P < 0.001). There was a significant relationship between age (P = 0.048), ASA class (P = 0.034), and educational level with the incidence of POCD, meaning that the probability of developing cognitive impairment decreases with patients' higher level of education and lower ASA-physical status. Also, the rate of POCD in men was significantly higher than in women (P = 0.026).
Conclusions
The finding of this study showed that, if there is no specific contraindication, neuraxial anesthesia may be preferred over general anesthesia in elderly patients.",2020,"Also, the rate of POCD in men was significantly higher than in women (P = 0.026).
","['Ninety-four patients over 50 years old scheduled for hip fracture fixation', 'Elderly Patients', 'Results\n\n\nNinety-four patients with a mean age of 67.12 years were studied', 'elderly patients']","['Mini-Mental State examination (MMSE', 'general and spinal anesthesia', 'general (GA) or spinal (SA) anesthesia', 'General Versus Spinal Anesthesia']","['rate of POCD', 'Postoperative Delirium and Early Cognitive Dysfunction', 'overall prevalence of POCD and delirium', 'incidence of delirium and POCD and their precipitating factors']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C4721773', 'cui_str': 'Postoperative cognitive dysfunction'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]",94.0,0.0376823,"Also, the rate of POCD in men was significantly higher than in women (P = 0.026).
","[{'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Ehsani', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soudabeh', 'Initials': 'S', 'LastName': 'Djalali Motlagh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behrooz', 'Initials': 'B', 'LastName': 'Zaman', 'Affiliation': 'Pain Research Center, Department of Anesthesiology and Pain Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saloumeh', 'Initials': 'S', 'LastName': 'Sehat Kashani', 'Affiliation': 'Pain Research Center, Department of Anesthesiology and Pain Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Ghodraty', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Iran University of Medical Sciences, Tehran, Iran.'}]",Anesthesiology and pain medicine,['10.5812/aapm.101815']
1668,33134223,Study of Demineralized Dental Enamel Treated with Different Fluorinated Compounds by Raman Spectroscopy.,"Background
Current diagnostic methods for enamel caries detection are unable to detect caries lesions (incipient caries lesion) at a very early stage.
Objective
This study aims to determine the remineralizing effect of three fluorinated compounds on demineralized subsurface tooth enamel using Raman spectroscopy characterization.
Material and Methods
In this experimental study, sixty impacted 3 rd molars, with intact anatomical crowns recently extracted and without structural defects, were sectioned longitudinally in a mesio-distal direction using a diamond disc, obtaining two working surfaces (buccal and lingual). The 120 working surfaces obtained were immersed for 96 h in a demineralization solution at 37°C in order to demineralize the enamel surface. All samples were randomly divided into three groups (n=30 each) and their surfaces were treated with silver diamine fluoride (SDF), Difluoride silane (DSF), and acidulated phosphate fluoride (APF), and with no treatment undertaken in the control group (CG). The samples were immersed in alternating solutions for demineralization and remineralization at pH 4.4 and pH 7.0, respectively. The results were analyzed with Principal Component Analysis (PCA) in order to determine the variance.
Results
The most important difference (91.7%) is observed in APF group between PCA1 respect to PCA2, followed by DSF (91.5%) and SDF (76.3%) respectively. Therefore, a greater remineralization in the dental enamel can be observed by the three experimental groups.
Conclusion
The APF and DSF have the effect of recovering the mineralization of dental enamel, except for the SDF. Functional groups OH - and PO43- were identified in all subsurface.",2020,"The most important difference (91.7%) is observed in APF group between PCA1 respect to PCA2, followed by DSF (91.5%) and SDF (76.3%) respectively.","['sixty impacted 3 rd molars, with intact anatomical crowns recently extracted and without structural defects, were sectioned longitudinally in a mesio-distal direction using a diamond disc, obtaining two working surfaces (buccal and lingual']","['Demineralized Dental Enamel Treated with Different Fluorinated Compounds by Raman Spectroscopy', 'silver diamine fluoride (SDF), Difluoride silane (DSF), and acidulated phosphate fluoride (APF']",[],"[{'cui': 'C0399550', 'cui_str': 'Impacted permanent canine tooth'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0226993', 'cui_str': 'Structure of crown of tooth'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0037815', 'cui_str': 'Analysis, Raman Spectrum'}, {'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0037093', 'cui_str': 'Silanes'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C3491832', 'cui_str': '(125I)APF'}]",[],,0.0213232,"The most important difference (91.7%) is observed in APF group between PCA1 respect to PCA2, followed by DSF (91.5%) and SDF (76.3%) respectively.","[{'ForeName': 'Barrera-Ortega', 'Initials': 'BO', 'LastName': 'C C', 'Affiliation': 'PhD, Coordinator Paediatric Stomatology Specialties. Iztacala Faculty of Higher Studies (FESI), National Autonomous University of Mexico (UNAM), State of Mexico, Mexico. Avenida de los Barrios No. 1 Col. Los Reyes Ixtacala Tlalnepantla de Baz, Estado de México CP. 54090.Mexico.'}, {'ForeName': 'Vázquez-Olmos', 'Initials': 'VO', 'LastName': 'A R', 'Affiliation': 'PhD, Institute of Applied and Technological Sciences, National Autonomous University of Mexico (UNAM), Circuito Exterior S/N C.P. 04510 Cd. Universitaria, Ciudad de México.'}, {'ForeName': 'Sato-Berrú', 'Initials': 'SB', 'LastName': 'R Y', 'Affiliation': 'PhD, Institute of Applied and Technological Sciences, National Autonomous University of Mexico (UNAM), Circuito Exterior S/N C.P. 04510 Cd. Universitaria, Ciudad de México.'}, {'ForeName': 'Araiza-Téllez', 'Initials': 'AT', 'LastName': 'M A', 'Affiliation': 'PhD, Dental Materials Laboratory, Division of Postgraduate Studies and Research of the Faculty of Dentistry, National Autonomous University of Mexico (UNAM), Circuito Institutos S/N Ciudad Universitaria, Colonia Copilco Universidad, Delegación Coyoacán, México Distrito Federal, C.P.'}]",Journal of biomedical physics & engineering,['10.31661/jbpe.v0i0.2003-1089']
1669,33134417,"Treating COVID-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind Randomized Controlled Trial in Hospitalized Patients.","Background
Effective therapies to combat coronavirus 2019 (COVID-19) are urgently needed. Hydroxychloroquine (HCQ) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but the clinical benefit of HCQ in treating COVID-19 is unclear. Randomized controlled trials are needed to determine the safety and efficacy of HCQ for the treatment of hospitalized patients with COVID-19.
Methods
We conducted a multicenter, double-blind randomized clinical trial of HCQ among patients hospitalized with laboratory-confirmed COVID-19. Subjects were randomized in a 1:1 ratio to HCQ or placebo for 5 days and followed for 30 days. The primary efficacy outcome was a severe disease progression composite end point (death, intensive care unit admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or vasopressor use) at day 14.
Results
A total of 128 patients were included in the intention-to-treat analysis. Baseline demographic, clinical, and laboratory characteristics were similar between the HCQ (n = 67) and placebo (n = 61) arms. At day 14, 11 (16.4%) subjects assigned to HCQ and 6 (9.8%) subjects assigned to placebo met the severe disease progression end point, but this did not achieve statistical significance ( P = .350). There were no significant differences in COVID-19 clinical scores, number of oxygen-free days, SARS-CoV-2 clearance, or adverse events between HCQ and placebo. HCQ was associated with a slight increase in mean corrected QT interval, an increased D-dimer, and a trend toward an increased length of stay.
Conclusions
In hospitalized patients with COVID-19, our data suggest that HCQ does not prevent severe outcomes or improve clinical scores. However, our conclusions are limited by a relatively small sample size, and larger randomized controlled trials or pooled analyses are needed.",2020,"HCQ was associated with a slight increase in mean corrected QT interval, an increased D-dimer, and a trend toward an increased length of stay.
","['patients hospitalized with laboratory-confirmed COVID-19', 'A total of 128 patients were included in the intention-to-treat analysis', 'hospitalized patients with COVID-19', 'Hospitalized Patients']","['Hydroxychloroquine (HCQ', 'placebo', 'HCQ', 'HCQ or placebo', 'Hydroxychloroquine (TEACH']","['safety and efficacy', 'severe disease progression composite end point (death, intensive care unit admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or vasopressor use) at day 14', 'length of stay', 'COVID-19 clinical scores, number of oxygen-free days, SARS-CoV-2 clearance, or adverse events', 'severe disease progression', 'mean corrected QT interval']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",128.0,0.763681,"HCQ was associated with a slight increase in mean corrected QT interval, an increased D-dimer, and a trend toward an increased length of stay.
","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Ulrich', 'Affiliation': 'Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Department of Population Health, New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Carmody', 'Affiliation': 'Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Jaishvi', 'Initials': 'J', 'LastName': 'Eapen', 'Affiliation': 'Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bäcker', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, NYU Long Island School of Medicine, Mineola, New York, USA.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'DeHovitz', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, State University of New York Downstate Health Sciences University, Brooklyn, New York, USA.'}, {'ForeName': 'Prithiv J', 'Initials': 'PJ', 'LastName': 'Prasad', 'Affiliation': 'Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Population Health, New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Delgado', 'Affiliation': 'New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Jrada', 'Affiliation': 'Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Gabriel A', 'Initials': 'GA', 'LastName': 'Robbins', 'Affiliation': 'Department of Pediatrics, New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Brooklyn', 'Initials': 'B', 'LastName': 'Henderson', 'Affiliation': 'Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hrycko', 'Affiliation': 'Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Dinuli', 'Initials': 'D', 'LastName': 'Delpachitra', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, NYU Long Island School of Medicine, Mineola, New York, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Raabe', 'Affiliation': 'Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Austrian', 'Affiliation': 'Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Yanina', 'Initials': 'Y', 'LastName': 'Dubrovskaya', 'Affiliation': 'Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Mulligan', 'Affiliation': 'Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa446']
1670,33134535,A randomized pilot study on self-management in head and neck lymphedema.,"Background
The purpose of this pilot trial was to determine the feasibility of a self-managed lymphedema randomized control trial to test the effectiveness of a head and neck-specific exercise protocol.
Methods
Nine participants were randomized to receive usual treatment provided by an Australian metropolitan teaching hospital (n = 4) or usual treatment with an added head and neck exercise regime (n = 5). Feasibility was assessed through ease of recruitment, adherence, and safety. Lymphedema reduction and quality of life (QOL) data were assessed at baseline (0 week) and follow-up (6 weeks).
Results
The study was feasible in terms of safety and participant retention. However, a slow recruitment rate and low adherence may impact future trials. There were no significant differences in lymphedema reduction or QOL between groups.
Conclusion
This pilot feasibility study demonstrated that a self-management trial can be implemented, however, modifications will be required due to the slow recruitment and poor adherence rates.
Level of evidence
1b: Individualized randomized control trial.",2020,"There were no significant differences in lymphedema reduction or QOL between groups.
",['head and neck lymphedema'],"['head and neck-specific exercise protocol', 'usual treatment provided by an Australian metropolitan teaching hospital (n = 4) or usual treatment with an added head and neck exercise regime']","['lymphedema reduction or QOL', 'ease of recruitment, adherence, and safety', 'Lymphedema reduction and quality of life (QOL) data']","[{'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}]","[{'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0454291', 'cui_str': 'Exercise regime'}]","[{'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",9.0,0.203041,"There were no significant differences in lymphedema reduction or QOL between groups.
","[{'ForeName': 'Tess M', 'Initials': 'TM', 'LastName': 'McLaughlin', 'Affiliation': 'The School of Occupational Therapy, Social Work and Speech Pathology Curtin University Perth Western Australia Australia.'}, {'ForeName': 'Jane J', 'Initials': 'JJ', 'LastName': 'Broadhurst', 'Affiliation': 'The School of Occupational Therapy, Social Work and Speech Pathology Curtin University Perth Western Australia Australia.'}, {'ForeName': 'Courtenay J', 'Initials': 'CJ', 'LastName': 'Harris', 'Affiliation': 'The School of Occupational Therapy, Social Work and Speech Pathology Curtin University Perth Western Australia Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McGarry', 'Affiliation': 'The School of Occupational Therapy, Social Work and Speech Pathology Curtin University Perth Western Australia Australia.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Keesing', 'Affiliation': 'The School of Occupational Therapy, Social Work and Speech Pathology Curtin University Perth Western Australia Australia.'}]",Laryngoscope investigative otolaryngology,['10.1002/lio2.455']
1671,33134539,Comprehensive auditory rehabilitation in adults receiving cochlear implants: A pilot study.,"Objective
In the United States, most adults who receive cochlear implants (CIs) do not undergo a comprehensive auditory rehabilitation (CAR) approach, which may result in suboptimal outcomes. The objectives of this pilot study were to demonstrate that a CAR approach incorporating auditory training (AT) by a speech-language pathologist (SLP) is feasible in adults receiving CIs and to explore whether this approach results in improved outcomes.
Methods
Twenty-four postlingually deaf adult CI candidates were serially assigned to one of three groups: (a) a ""CAR group"" that received standard of care implantation, programming by an audiologist, an additional preoperative counseling session, and eight one-hour AT sessions; (b) a ""passive control"" standard-of-care group; and (c) an ""active control"" group that also received the extra preoperative counseling session. Participants were tested preoperatively and 1, 3, and 6 months after CI using measures of word and sentence recognition in quiet and in babble, as well as measures of quality of life (QOL).
Results
The CAR approach was feasible, but this pilot study was underpowered to determine efficacy. Differential time courses of speech recognition improvement were seen for sentence and word recognition. All QOL measurements showed improvement from pre-CI to 1 month post-CI activation. Results revealed issues to consider for a larger-scale study of CAR revolving around participant selection, study measures, and sample size.
Conclusion
The CAR approach is feasible in new CI users. A larger trial is needed to investigate whether CAR leads to better outcomes or faster improvement in this clinical population.
Level of Evidence
2.",2020,Differential time courses of speech recognition improvement were seen for sentence and word recognition.,"['adults receiving cochlear implants', 'Methods\n\n\nTwenty-four postlingually deaf adult CI candidates']","['comprehensive auditory rehabilitation (CAR) approach', 'CAR group"" that received standard of care implantation, programming by an audiologist, an additional preoperative counseling session, and eight one-hour AT sessions; (b) a ""passive control"" standard-of-care group; and (c) an ""active control"" group that also received the extra preoperative counseling session', 'CAR approach incorporating auditory training (AT) by a speech-language pathologist (SLP', 'Comprehensive auditory rehabilitation']","['word and sentence recognition in quiet and in babble, as well as measures of quality of life (QOL']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}]","[{'cui': 'C0200323', 'cui_str': 'Auditory rehabilitation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0175838', 'cui_str': 'Audiologist'}, {'cui': 'C0920638', 'cui_str': 'Preoperative counseling'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0334866', 'cui_str': 'Medical pathologist'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0856983', 'cui_str': 'Babbling'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",24.0,0.137111,Differential time courses of speech recognition improvement were seen for sentence and word recognition.,"[{'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Moberly', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery The Ohio State University Wexner Medical Center Columbus Ohio USA.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Vasil', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery The Ohio State University Wexner Medical Center Columbus Ohio USA.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Baxter', 'Affiliation': 'Department of Speech and Hearing Science The Ohio State University Columbus Ohio USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Klamer', 'Affiliation': 'Center for Biostatistics, Department of Biomedical Informatics The Ohio State University Columbus Ohio USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kline', 'Affiliation': 'Center for Biostatistics, Department of Biomedical Informatics The Ohio State University Columbus Ohio USA.'}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Ray', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery The Ohio State University Wexner Medical Center Columbus Ohio USA.'}]",Laryngoscope investigative otolaryngology,['10.1002/lio2.442']
1672,33134810,"An open-label, randomized controlled trial of sulfamethoxazole-trimethoprim for Pneumocystis prophylaxis: results of 52-week follow-up.","Objectives
The aim was to investigate the long-term prophylactic efficacy, drug retention and safety of low-dose sulfamethoxazole-trimethoprim (SMX/TMP) prophylaxis against Pneumocystis pneumonia (PCP).
Methods
Adult patients with rheumatic diseases receiving prednisolone ≥0.6 mg/kg/day were randomized into the single-strength group (SS; SMX/TMP 400/80 mg daily), the half-strength group (HS; 200/40 mg daily) or the escalation group (ES; starting at 40/8 mg and increasing incrementally to 200/40 mg daily) and treated for 24 weeks, then observed for 52 weeks. The primary endpoint, the PCP non-incidence rate (non-IR) at week 24, has been reported previously. The secondary endpoints were the PCP non-IR at week 52, treatment discontinuation rate and adverse events.
Results
Fifty-eight, 59 and 55 patients in the SS, HS and ES, respectively, received SMX/TMP. PCP did not develop in any of the patients by week 52. The estimated PCP non-IR in patients receiving SMX/TMP 200/40 mg daily (HS and ES) was 96.8-100%. Throughout the 52-week observation period, the overall discontinuation rate was significantly lower in HS than in SS (22.7 vs 47.2%, P = 0.004). The discontinuation rates attributable to adverse events were significantly lower in HS (19.1%, P = 0.007) and ES (20.3%, P = 0.007) than in SS (41.8%). The IRs of adverse events requiring SMX/TMP dose reduction before week 52 differed among the three groups, with a significantly higher IR in SS than in HS or ES ( P = 0.007).
Conclusion
SMX/TMP 200/40 mg had a high PCP prevention rate and was superior to SMX/TMP 400/80 mg in terms of drug retention and safety.
Trial registration
University Hospital Medical Information Network Clinical Trials Registry, UMIN000007727.",2020,mg had a high PCP prevention rate and was superior to SMX/TMP 400/80 ,"['Pneumocystis prophylaxis', 'Adult patients with rheumatic diseases receiving prednisolone ≥0.6\u2009mg/kg/day']","['sulfamethoxazole-trimethoprim', 'single-strength group (SS; SMX/TMP 400/80\u2009mg daily), the half-strength group (HS; 200/40\u2009mg daily) or the escalation group (ES; starting at 40/8\u2009mg and increasing incrementally to 200/40\u2009mg daily', 'SMX/TMP', 'sulfamethoxazole-trimethoprim (SMX/TMP) prophylaxis', 'PCP']","['IRs of adverse events requiring SMX/TMP dose reduction', 'overall discontinuation rate', 'PCP non-IR at week\u200952, treatment discontinuation rate and adverse events', 'PCP non-incidence rate (non-IR']","[{'cui': 'C0597258', 'cui_str': 'Pneumocystis'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.121827,mg had a high PCP prevention rate and was superior to SMX/TMP 400/80 ,"[{'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Utsunomiya', 'Affiliation': 'Department of Rheumatic Diseases, Tokyo Metropolitan Tama Medical Center, Fuchu, Tokyo.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Dobashi', 'Affiliation': 'Division of Hematology, Rheumatology and Respiratory Medicine, Department of Internal Medicine, Faculty of Medicine, Kagawa University, Kida-gun, Kagawa.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Odani', 'Affiliation': 'Third Department of Internal Medicine, Obihiro-Kosei General Hospital, Obihiro, Hokkaido.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Yokogawa', 'Affiliation': 'Department of Rheumatic Diseases, Tokyo Metropolitan Tama Medical Center, Fuchu, Tokyo.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Nagasaka', 'Affiliation': 'Departments of Pharmacovigilance.'}, {'ForeName': 'Kenchi', 'Initials': 'K', 'LastName': 'Takenaka', 'Affiliation': 'Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Soejima', 'Affiliation': 'Department of Rheumatology, Ome Municipal General Hospital, Ome, Tokyo.'}, {'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Sugihara', 'Affiliation': 'Department of Medicine and Rheumatology, Tokyo Metropolitan Geriatric Hospital, Tokyo.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Hagiyama', 'Affiliation': 'Department of Rheumatology, Yokohama City Minato Red Cross Hospital, Yokohama, Kanagawa.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Hirata', 'Affiliation': 'Department of Hematology, Rheumatology, and Infectious Disease, Kumamoto University Graduate School of Medicine, Kumamoto, Kumamoto.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Matsui', 'Affiliation': 'Department of Rheumatology, Kameda Medical Center, Kamogawa, Chiba.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Nonomura', 'Affiliation': 'Department of Rheumatology, Tokyo Kyosai Hospital, Tokyo.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Department of Rheumatology, Faculty of Medicine, Shimane University, Izumo, Shimane.'}, {'ForeName': 'Fumihito', 'Initials': 'F', 'LastName': 'Suzuki', 'Affiliation': 'Department of Rheumatology, Soka Municipal Hospital, Soka, Saitama.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Nawata', 'Affiliation': 'Center for Rheumatic Disease, Chibaken Saiseikai Narashino Hospital, Narashino, Chiba.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tomita', 'Affiliation': 'Clinical Research Center, Medical Hospital of Tokyo Medical and Dental University.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Kihara', 'Affiliation': 'Departments of Pharmacovigilance.'}, {'ForeName': 'Waka', 'Initials': 'W', 'LastName': 'Yokoyama-Kokuryo', 'Affiliation': 'Departments of Pharmacovigilance.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Hirano', 'Affiliation': 'Departments of Pharmacovigilance.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Yamazaki', 'Affiliation': 'Departments of Pharmacovigilance.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Sakai', 'Affiliation': 'Departments of Pharmacovigilance.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Nanki', 'Affiliation': 'Departments of Pharmacovigilance.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Koike', 'Affiliation': 'Departments of Pharmacovigilance.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Miyasaka', 'Affiliation': 'Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Harigai', 'Affiliation': 'Departments of Pharmacovigilance.'}]",Rheumatology advances in practice,['10.1093/rap/rkaa029']
1673,33134935,Video Laryngoscope Intubation With an Aerosol Barrier Device: A Randomized Sequential Crossover Pilot Study.,"Objectives
To assess the impact of the use of aerosol barrier device, Splashguard-CG, on the endotracheal intubation with different types of laryngoscope.
Design
A pilot randomized sequential crossover simulation study.
Setting
A single academic center in Japan.
Subjects
Physicians in a single academic university hospital in Japan.
Interventions
Use of Splashguard-CG.
Measurements and Main Results
All participants were asked to perform endotracheal intubation to a manikin simulator using three different devices (Macintosh laryngoscope; Airway Scope [Nihon Kohden, Tokyo, Japan]; and McGRATH MAC [Aircraft Medical, Edinburgh, United Kingdom]) with and without Splashguard-CG in place, which required a total of six attempts and measured the intubation time as the primary outcome. Thirty physicians (15 experienced physicians and 15 less-experienced physicians) were included. Intubation time using Macintosh laryngoscope was significantly longer in the group with Macintosh laryngoscope and Splashguard-CG compared with the group without Splashguard-CG by the median difference of 4.3 seconds (interquartile range, 2.6-7.4 s; p < 0.001). There was no significant increase in the intubation time with or without Splashguard-CG for the Airway Scope (0.6 s; interquartile range, -3.7 to 3.2 s; p = 0.97) and the McGRATH MAC (0.5 s; interquartile range, -1.4 to 4.6 s; p = 0.09). This trend was found in both the experienced and less-experienced groups. We observed significant increases of subjective difficulty of the endotracheal intubation evaluated by using a Visual Analog Scale in the Splashguard-CG groups for all three types of devices.
Conclusions
The use of a video laryngoscope with an aerosol barrier device does not impact the time required endotracheal intubation in a simulation environment. This method can be considered as airway management for coronavirus disease 2019.",2020,"Intubation time using Macintosh laryngoscope was significantly longer in the group with Macintosh laryngoscope and Splashguard-CG compared with the group without Splashguard-CG by the median difference of 4.3 seconds (interquartile range, 2.6-7.4 s; ","['Subjects\n\n\nPhysicians in a single academic university hospital in Japan', 'Thirty physicians (15 experienced physicians and 15 less-experienced physicians', 'Setting\n\n\nA single academic center in Japan']","['aerosol barrier device, Splashguard-CG', 'video laryngoscope with an aerosol barrier device', 'Splashguard-CG', 'Video Laryngoscope Intubation With an Aerosol Barrier Device', 'endotracheal intubation to a manikin simulator using three different devices (Macintosh laryngoscope; Airway Scope [Nihon Kohden, Tokyo, Japan]; and McGRATH MAC']","['Visual Analog Scale', 'Intubation time using Macintosh laryngoscope', 'intubation time', 'subjective difficulty of the endotracheal intubation']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]",,0.104488,"Intubation time using Macintosh laryngoscope was significantly longer in the group with Macintosh laryngoscope and Splashguard-CG compared with the group without Splashguard-CG by the median difference of 4.3 seconds (interquartile range, 2.6-7.4 s; ","[{'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Idei', 'Affiliation': ""Department of Intensive Care Medicine, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nomura', 'Affiliation': ""Department of Intensive Care Medicine, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Jouvet', 'Affiliation': 'Department of Pediatrics, CHU Sainte-Justine, University of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Carl Eric', 'Initials': 'CE', 'LastName': 'Aubin', 'Affiliation': 'Department of Mechanical Engineering, Polytechnique Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kawaguchi', 'Affiliation': ""Department of Intensive Care Medicine, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Nakagawa', 'Affiliation': ""Department of Intensive Care Medicine, Tokyo Women's Medical University, Tokyo, Japan.""}]",Critical care explorations,['10.1097/CCE.0000000000000234']
1674,33134951,Resolution of Coronavirus Disease 2019 Infection and Pulmonary Pathology With Nebulized DAS181: A Pilot Study.,"Objectives
Severe acute respiratory syndrome coronavirus 2 infections commonly lead to respiratory failure and potentially fatal systemic inflammation and organ failure. Nebulized DAS181, a host-directed biologics with sialidase activity, is an investigational drug with antiviral activities on parainfluenza and influenza under phase 3 and phase 2 development. The objective of this study (NCT04324489) is to investigate the safety and effects of nebulized DAS181 on hypoxic coronavirus disease 2019 patients.
Design
Single-center, prospective, open-label, compassionate use.
Setting
Renmin Hospital of Wuhan University, Department of Respiratory and Critical Care Medicine and Department of Infectious Diseases.
Subjects
Patients 18 to 70 years old who met Chinese criteria for severe coronavirus disease 2019 pneumonia and required supplemental oxygen but not on mechanical ventilator at screening.
Interventions
Nebulized DAS181 (4.5 mg) twice a day for 10 days.
Measurements and Main Results
Three male coronavirus disease 2019 hypoxic patients with bilateral lung involvement completed DAS181 treatment for 10 days. By day 14, all achieved return to room air (primary endpoint) and their nasopharyngeal swabs were negative for severe acute respiratory syndrome coronavirus 2. Clinical severity improved from severe coronavirus disease 2019 at baseline to moderate or mild disease by day 5, consistent with rapid reduction of inflammatory cytokines by days 2-3 and radiologic improvement by days 5-10. No DAS181-related adverse events were reported.
Conclusions
Inhalation of DAS181 was well tolerated and potential clinical benefit of DAS181 on hypoxic coronavirus disease 2019 is the reduction of supplemental oxygen need. Efficacy and safety, including pharmacokinetics and viral studies of DAS181 in severe, hypoxic coronavirus disease 2019, should be examined by a double-blind, randomized controlled study.",2020,"No DAS181-related adverse events were reported.
","['hypoxic coronavirus disease 2019 patients', 'Subjects\n\n\nPatients 18 to 70 years old who met Chinese criteria for severe coronavirus disease 2019 pneumonia and required supplemental oxygen but not on mechanical ventilator at screening', 'Setting\n\n\nRenmin Hospital of Wuhan University, Department of Respiratory and Critical Care Medicine and Department of Infectious Diseases', 'Three male coronavirus disease 2019 hypoxic patients with bilateral lung involvement completed DAS181 treatment for 10 days']","['Nebulized DAS181', 'DAS181', 'nebulized DAS181']","['Efficacy and safety', 'Resolution of Coronavirus Disease 2019 Infection and Pulmonary Pathology', 'inflammatory cytokines']","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0042497', 'cui_str': 'Mechanical ventilator'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1319411', 'cui_str': 'Critical care medicine'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0225754', 'cui_str': 'Both lungs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2003387', 'cui_str': 'DAS181'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C2003387', 'cui_str': 'DAS181'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",3.0,0.066004,"No DAS181-related adverse events were reported.
","[{'ForeName': 'Jennifer Hui-Chun', 'Initials': 'JH', 'LastName': 'Ho', 'Affiliation': 'Division of Clinical Development, Ansun Biopharma, San Diego, CA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Zhenlian', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Xiaobei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Yunyan', 'Initials': 'Y', 'LastName': 'Xianyu', 'Affiliation': 'Nursing Department, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Division of Clinical Development, Ansun Biopharma, San Diego, CA.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Division of Clinical Development, Ansun Biopharma, San Diego, CA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Chang', 'Affiliation': 'Division of Clinical Development, Ansun Biopharma, San Diego, CA.'}, {'ForeName': 'Zuojiong', 'Initials': 'Z', 'LastName': 'Gong', 'Affiliation': 'Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}]",Critical care explorations,['10.1097/CCE.0000000000000263']
1675,33134974,Traumastem Powder in Treatment of Non-Traumatic Anterior Epistaxis in Emergency Department; a Randomized Clinical Trial.,"Introduction
Various studies are being conducted because of the value of finding an appropriate medication to control bleeding in patients with epistaxis faster and more conveniently. This study aimed to compare the effect of Traumastem powder with routine tampons in treatment of non-traumatic epistaxis.
Methods
This randomized clinical trial enrolled patients with epistaxis presenting to the emergency departments of two hospitals affiliated to Tabriz University of Medical sciences. Patients were divided into two groups using randomization software (intervention group: 107 patients, control group: 96 patients). Primary outcome variables included bleeding control time and patient satisfaction. Secondary outcome variable was recurrence of bleeding within the first 24 hours after treatment. Visual assessment scoring system was used to assess patient satisfaction.
Results
Epistaxis was controlled in less than 5 minutes in 85 (79.4%) patients in the intervention group and 85 (88.5%) patients in the control group (P=0.058). Patient satisfaction in the intervention group was higher than that of the control group (P<0.05). In the intervention group, 10 patients experienced recurrence of epistaxis within 24 hours of treatment, while 9 patients in the control group experienced recurrence (P= 0.591).
Conclusion
Based on the findings, bleeding control time was similar in the two groups, but patient satisfaction was higher in Traumastem group. It is concluded that Traumastem can conveniently control anterior epistaxis, but it is not successful in cases with severe bleeding.",2020,Patient satisfaction in the intervention group was higher than that of the control group (P<0.05).,"['patients with epistaxis presenting to the emergency departments of two hospitals affiliated to Tabriz University of Medical sciences', 'Non-Traumatic Anterior Epistaxis in Emergency Department']","['Traumastem powder with routine tampons', 'Traumastem Powder']","['Epistaxis', 'recurrence of epistaxis', 'Patient satisfaction', 'recurrence of bleeding', 'patient satisfaction', 'bleeding control time and patient satisfaction', 'recurrence', 'bleeding control time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]","[{'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039288', 'cui_str': 'Tampon'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0551296,Patient satisfaction in the intervention group was higher than that of the control group (P<0.05).,"[{'ForeName': 'Mahboob', 'Initials': 'M', 'LastName': 'Pouraghaei', 'Affiliation': 'Emergency Medicine Research Team, Tabriz University of Medical Sciences, Tabriz, East Azerbaijan, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Shafiee', 'Affiliation': 'Emergency Medicine Research Team, Tabriz University of Medical Sciences, Tabriz, East Azerbaijan, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Mesrian', 'Affiliation': 'Emergency Medicine Research Team, Tabriz University of Medical Sciences, Tabriz, East Azerbaijan, Iran.'}, {'ForeName': 'Haniyeh', 'Initials': 'H', 'LastName': 'Ebrahimi Bakhtavar', 'Affiliation': 'Emergency Medicine Research Team, Tabriz University of Medical Sciences, Tabriz, East Azerbaijan, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Rahmani', 'Affiliation': 'Emergency Medicine Research Team, Tabriz University of Medical Sciences, Tabriz, East Azerbaijan, Iran.'}]",Archives of academic emergency medicine,[]
1676,33139038,"Assessment of the Clinical Impact of a Liver-Specific, BCAA-Enriched Diet in Major Liver Surgery.","BACKGROUND
The relationship between nutrition and liver disease is relevant for the outcome after surgery. Patients with liver cirrhosis characteristically show protein-energy malnutrition with decreased levels of branched-chain amino acids (BCAA) and increased levels of aromatic amino acids.
MATERIALS AND METHODS
We conducted a prospective controlled clinical trial including 57 patients after liver transplantation or major liver resection surgery in order to test the effect of early postoperative nutrition on the outcome and nutrition profile of these patients. The test group received a dietetic program composed of ingredients naturally rich in BCAA (BCAA group), and the control group received standard hospital meals. Patient survival, liver function tests, subjective well-being, and a nutritional status including amino acid profiles were analyzed immediately and 14 days after major liver surgery (secondary end points). General health and well-being were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (primary end point).
RESULTS
In-depth analysis of amino acid profiles was performed for patients undergoing liver resection (n = 21) and liver transplantation (n = 36). Interestingly, amino acid profiles did not correlate with body mass index or the Model for End-Stage Liver Disease score. Patients scheduled for liver transplantation showed significantly lower levels of BCAA pretransplant compared to patients undergoing liver resection. Patients in the liver resection subgroup were more likely to benefit from the BCAA cuisine in terms of significantly higher food intake and subjective rating. The clinical liver function tests, however, did not show statistical difference between the BCAA group and the control group in the examination period of 14 days.
CONCLUSION
Our specifically designed BCAA-enriched diet resulted in greater patient satisfaction and compliance with nutrition. A larger trial or longer-term follow-up may be required to identify an effect on survival, recovery, surgical complications, protein profiles, and amino acid profiles.",2020,"The clinical liver function tests, however, did not show statistical difference between the BCAA group and the control group in the examination period of 14 days.
","['Major Liver Surgery', '57 patients after liver transplantation or major liver resection surgery in order to test the effect of early postoperative nutrition on the outcome and nutrition profile of these patients', 'Patients with liver cirrhosis', 'patients undergoing liver resection (n\xa0= 21) and liver transplantation (n\xa0= 36']","['dietetic program composed of ingredients naturally rich in BCAA (BCAA group), and the control group received standard hospital meals', 'Liver-Specific, BCAA-Enriched Diet', 'BCAA']","['food intake and subjective rating', 'Patient survival, liver function tests, subjective well-being, and a nutritional status including amino acid profiles', 'levels of BCAA pretransplant', 'branched-chain amino acids (BCAA) and increased levels of aromatic amino acids', 'survival, recovery, surgical complications, protein profiles, and amino acid profiles']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0193373', 'cui_str': 'Operation on liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]","[{'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0301713', 'cui_str': 'Aromatic amino acid'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444680', 'cui_str': 'Protein profiling'}]",57.0,0.0433087,"The clinical liver function tests, however, did not show statistical difference between the BCAA group and the control group in the examination period of 14 days.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Krapf', 'Affiliation': 'Department of Surgery, University Hospital for Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria; Department of Plastic, Reconstructive and Aesthetic Surgery, Innsbruck Medical University and Tirol Kliniken Medical Center Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schuhbeck', 'Affiliation': 'Schuhbecks Internet GmbH, Munich, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wendel', 'Affiliation': 'Private Practice, Lindau, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fritz', 'Affiliation': 'Department of Medical Statistics, Informatics and Health Economics, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Scholl-Bürgi', 'Affiliation': 'Department of Pediatrics I, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bösmüller', 'Affiliation': 'Department of Surgery, University Hospital for Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Oberhuber', 'Affiliation': 'Department of Surgery, University Hospital for Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Margreiter', 'Affiliation': 'Department of Surgery, University Hospital for Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maglione', 'Affiliation': 'Department of Surgery, University Hospital for Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stättner', 'Affiliation': 'Department of Surgery, University Hospital for Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Messner', 'Affiliation': 'Department of Surgery, University Hospital for Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Berchtold', 'Affiliation': 'Department of Surgery, University Hospital for Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Braunwarth', 'Affiliation': 'Department of Surgery, University Hospital for Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Primavesi', 'Affiliation': 'Department of Surgery, University Hospital for Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cardini', 'Affiliation': 'Department of Surgery, University Hospital for Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Resch', 'Affiliation': 'Department of Surgery, University Hospital for Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Karall', 'Affiliation': 'Department of Pediatrics I, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Öfner', 'Affiliation': 'Department of Surgery, University Hospital for Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Margreiter', 'Affiliation': 'Department of Surgery, University Hospital for Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schneeberger', 'Affiliation': 'Department of Surgery, University Hospital for Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria. Electronic address: stefan.schneeberger@i-med.ac.at.'}]",Transplantation proceedings,['10.1016/j.transproceed.2020.09.013']
1677,33139133,"Effect of a vaccine information statement (VIS) on immunization status and parental knowledge, attitudes, and beliefs regarding infant immunization in Japan.","BACKGROUND
Because of the overabundance of vaccination information on the internet, in the media, and on social media, providing clear and correct information on immunization is critical for parental decision-making. In 2018, the Japan Pediatric Society created and distributed a Vaccine Information Statement (VIS) to provide appropriate immunization information to caregivers. The objectives of the present study were to evaluate the effect of the VIS on immunization rates, adherence to schedule, and parental understanding of immunization in Japan.
METHODS
This cross-sectional study was conducted at 18 centers in 2 prefectures in Japan. Caregivers were assigned to an intervention group, which received the VIS and a questionnaire when their child reached the age of 1 month, and a control group, which received only the questionnaire. Using the self-reported questionnaires, we evaluated vaccination rates and schedule adherence at age 2 months, and parental knowledge, attitudes, and beliefs regarding immunization. Three months later, the questionnaires were returned, and the findings were compared between the 2 groups.
RESULTS
We contacted 422 and 428 persons in the intervention and control groups, respectively, and 111/422 (26.3%) and 119/428 (27.8%) returned the surveys. Vaccination rates and adherence rates for the first dose of 4 recommended vaccines did not differ significantly (P > 0.25); however, there were some positive effects on items related to vaccine knowledge (P = 0.03), perceived benefits (P = 0.02), perceived barriers (P < 0.001), and perceived behavioral control (P = 0.01).
CONCLUSION
The VIS improved parent comprehension of infant immunization. Future studies should examine if the effects of such an intervention persist and affect vaccine uptake throughout childhood.",2020,"Vaccination rates and adherence rates for the first dose of 4 recommended vaccines did not differ significantly (P > 0.25); however, there were some positive effects on items related to vaccine knowledge (P = 0.03), perceived benefits (P = 0.02), perceived barriers (P < 0.001), and perceived behavioral control (P = 0.01).
","['Japan', '422 and 428 persons in the intervention and control groups, respectively, and 111/422 (26.3%) and 119/428 (27.8%) returned the surveys', '18 centers in 2 prefectures in Japan']",['vaccine information statement (VIS'],"['immunization status and parental knowledge, attitudes, and beliefs regarding infant immunization', 'Vaccination rates and adherence rates', 'vaccination rates and schedule adherence at age 2\xa0months, and parental knowledge, attitudes, and beliefs regarding immunization', 'behavioral control']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4517775', 'cui_str': '428'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0552506', 'cui_str': 'Immunization status'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0376148,"Vaccination rates and adherence rates for the first dose of 4 recommended vaccines did not differ significantly (P > 0.25); however, there were some positive effects on items related to vaccine knowledge (P = 0.03), perceived benefits (P = 0.02), perceived barriers (P < 0.001), and perceived behavioral control (P = 0.01).
","[{'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Saitoh', 'Affiliation': 'Department of Nursing, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. Electronic address: ayasaitoh8@clg.niigata-u.ac.jp.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Saitoh', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Katsuta', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, St. Marianna University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Mahito', 'Initials': 'M', 'LastName': 'Mine', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Mine Pediatric Clinic, Saitama, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Kamiya', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Infectious Disease Surveillance Center, National Institute of Infectious Diseases, Tokyo, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Miyairi', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Division of Infectious Diseases, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Naruhiko', 'Initials': 'N', 'LastName': 'Ishiwada', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Infectious Diseases, Medical Mycology Research Center, Chiba University, Chiba, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Oshiro', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Neonatology, Japanese Red Cross Nagoya Daiichi Hospital, Aichi, Japan.'}, {'ForeName': 'Ryutaro', 'Initials': 'R', 'LastName': 'Kira', 'Affiliation': ""The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatric Neurology, Fukuoka Children's Hospital, Fukuoka, Japan.""}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Shimizu', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, St. Marianna University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Suga', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Infectious Disease Center and Department of Clinical Research, National Hospital Organization Mie Hospital, Mie, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Tsugawa', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, Sapporo Medical University School of Medicine, Hokkaido, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Fujioka', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Fujioka Pediatrics, Osaka, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Miyazaki', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Fukuoka Welfare Center for the Disabled, Fukuoka, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Morioka', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Seigo', 'Initials': 'S', 'LastName': 'Korematsu', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakano', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Tanaka-Taya', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Infectious Disease Surveillance Center, National Institute of Infectious Diseases, Tokyo, Japan.'}, {'ForeName': 'Tetsushi', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, Fujita Health University School of Medicine, Aichi, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Iwata', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Infectious Diseases, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kusuhara', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, University of Occupational and Environmental Health, Fukuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Azuma', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, Asahikawa Medical University, Hokkaido, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Moriuchi', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Okabe', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Kawasaki City Institute for Public Health, Kanagawa, Japan.'}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Hosoya', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsutsumi', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, Sapporo Medical University School of Medicine, Hokkaido, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Division of Basic Nursing, Fukuoka Nursing College, Fukuoka, Japan.'}]",Vaccine,['10.1016/j.vaccine.2020.10.049']
1678,33139136,Repeated exposure to an MF-59 adjuvanted quadrivalent subunit influenza vaccine (aQIV) in children: Results of two revaccination studies.,"BACKGROUND
Pediatric adjuvanted seasonal influenza vaccines induce higher immune responses and have the potential to confer better protection against influenza among young vaccine-naïve children. Limited data describe benefits and risks of repeated administration of adjuvanted influenza vaccines in children. Two revaccination studies assess the safety and immunogenicity of repeated exposure to an MF59-adjuvanted quadrivalent influenza vaccine (aQIV; Fluad®) compared to routine non-adjuvanted quadrivalent influenza vaccine (QIV).
METHODS
Children previously enrolled in the parent study, who received vaccination with aQIV or nonadjuvanted influenza vaccine (TIV or QIV), were recruited in Season 1 (n = 607) or Season 2 (n = 1601) of the extension trials. Season 1 participants remained in their original randomization groups (aQIV-aQIV or TIV-QIV); Season 2 subjects were re-randomized to either vaccine, resulting in four groups (aQIV-aQIV, aQIV-QIV, QIV-aQIV, or QIV-QIV). All subjects received a single-dose vaccination. Blood samples were taken for immunogenicity assessment prior to vaccination and 21 and 180 days after vaccination. Reactogenicity (Days 1-7) and safety were assessed in all subjects.
RESULTS
Hemagglutination inhibition (HI) geometric mean titer (GMT) ratios demonstrated superiority of aQIV revaccination over QIV revaccination for all strains in Season 1 and for A/H1N1, B/Yamagata, and B/Victoria in Season 2. Higher HI titers against heterologous influenza strains were observed after aQIV vaccination during both seasons. Mild to moderate severity and short duration reactogenicity was more common in the aQIV than QIV groups, but the overall safety profiles were similar to the parent study.
CONCLUSION
The safety and immunogenicity results from this study demonstrate benefit of aQIV for both priming and revaccination of children aged 12 months to 7 years.",2020,"RESULTS
Hemagglutination inhibition (HI) geometric mean titer (GMT) ratios demonstrated superiority of aQIV revaccination over QIV revaccination for all strains in Season 1 and for A/H1N1, B/Yamagata, and B/Victoria in Season 2.","['children', 'children aged 12\xa0months to 7\xa0years', 'Children previously enrolled in the parent study, who received vaccination with aQIV or nonadjuvanted influenza vaccine (TIV or QIV), were recruited in Season 1 (n\xa0=\xa0607) or Season 2 (n\xa0=\xa01601) of the extension trials', 'young vaccine-naïve children']","['MF-59 adjuvanted quadrivalent subunit influenza vaccine (aQIV', 'routine non-adjuvanted quadrivalent influenza vaccine (QIV', 'vaccine', 'adjuvanted influenza vaccines', 'MF59-adjuvanted quadrivalent influenza vaccine (aQIV; Fluad®']","['overall safety profiles', 'Reactogenicity', 'Mild to moderate severity and short duration reactogenicity', 'Hemagglutination inhibition (HI) geometric mean titer (GMT) ratios']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0574482', 'cui_str': 'Tiv language'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0289787', 'cui_str': 'MF59 oil emulsion'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0769254,"RESULTS
Hemagglutination inhibition (HI) geometric mean titer (GMT) ratios demonstrated superiority of aQIV revaccination over QIV revaccination for all strains in Season 1 and for A/H1N1, B/Yamagata, and B/Victoria in Season 2.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Vesikari', 'Affiliation': 'Nordic Research Network Oy, Tampere, Finland. Electronic address: timo.vesikari@gmail.com.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ramsey', 'Affiliation': 'Jordan Ridge Kids & Teens, West Jordan, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pitisuttithum', 'Affiliation': 'Mahidol University, Department of Clinical Tropical Medicine, Bangkok, Thailand.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Capeding', 'Affiliation': 'Research Institute for Tropical Medicine, Muntinlupa, Philippines.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Heijnen', 'Affiliation': 'Janssen Vaccines & Prevention B.V., Leiden, the Netherlands.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Sawlwin', 'Affiliation': 'Seqirus Australia Pty Ltd, Parkville, Australia.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Oberyé', 'Affiliation': 'Seqirus Netherlands BV, Clinical Science and Strategy, Amsterdam, The Netherlands.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Seqirus Inc, Clinical Science and Strategy, Cambridge, USA.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Smolenov', 'Affiliation': 'Seqirus Inc, Clinical Science and Strategy, Cambridge, USA.'}]",Vaccine,['10.1016/j.vaccine.2020.10.036']
1679,33139143,A multifaceted intervention improves antibiotic stewardship for skin and soft tissues infections.,"OBJECTIVE
Assess the effectiveness of a multifaceted stewardship intervention to reduce frequency and duration of inappropriate antibiotic use for emergency department (ED) patients with skin and soft tissue infections (SSTI). We hypothesized the antibiotic stewardship program would reduce antibiotic duration and improve guideline adherence in discharged SSTI patients.
DESIGN
Nonrandomized controlled trial.
SETTING
Academic EDs (intervention site and control site).
PATIENTS OR PARTICIPANTS
Attending physicians and nurse practitioners at participating EDs.
INTERVENTION(S)
Education regarding guideline-based treatment of SSTI, tests of antimicrobial treatment of SSTI, implementation of a clinical treatment algorithm and order set in the electronic health record, and ED clinicians' audit and feedback.
RESULTS
We examined 583 SSTIs. At the intervention site, clinician adherence to guidelines improved from 41% to 51% (aOR = 2.13 [95% CI: 1.20-3.79]). At the control site, there were no changes in adherence during the ""intervention"" period (aOR = 1.17 [0.65-2.12]). The between-site comparison of these during vs. pre-intervention odds ratios was not different (aOR = 1.82 [0.79-4.21]). Antibiotic duration decreased by 26% at the intervention site during the intervention compared to pre-intervention (Adjusted Geometric Mean Ratio [95% CI] = 0.74 [0.66-0.84]). Adherence was inversely associated with SSTI severity (severe vs mild; adjusted OR 0.42 [0.20-0.89]) and purulence (0.32 [0.21-0.47]). Mean antibiotic prescription duration was 1.95 days shorter (95% CI: 1.54-2.33) in the time period following the intervention than pre-intervention period.
CONCLUSIONS
A multifaceted intervention resulted in modest improvement in adherence to guidelines compared to a control site, driven by treatment duration reductions.",2020,"A multifaceted intervention resulted in modest improvement in adherence to guidelines compared to a control site, driven by treatment duration reductions.","['discharged SSTI patients', 'emergency department (ED) patients with skin and soft tissue infections (SSTI', 'Attending physicians and nurse practitioners at participating EDs']","['antibiotic stewardship program', 'multifaceted stewardship intervention']","['Antibiotic duration', 'SSTI severity', 'adherence', 'Mean antibiotic prescription duration', 'antibiotic duration and improve guideline adherence']","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0149778', 'cui_str': 'Soft tissue infection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1320929', 'cui_str': 'Attending physician'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}]","[{'cui': 'C4505100', 'cui_str': 'Antibiotic Stewardship'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0149778', 'cui_str': 'Soft tissue infection'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0525059', 'cui_str': 'Guideline Adherence'}]",,0.0482885,"A multifaceted intervention resulted in modest improvement in adherence to guidelines compared to a control site, driven by treatment duration reductions.","[{'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'May', 'Affiliation': 'Department of Emergency Medicine, University of California, Davis, 2315 Stockton Blvd., Sacramento, CA 96817, USA. Electronic address: lsmay@ucdavis.edu.'}, {'ForeName': 'Megan H', 'Initials': 'MH', 'LastName': 'Nguyen', 'Affiliation': 'Western University of Health Sciences, Pomona, CA, United States of America; Division of Infectious Diseases, Harbor-UCLA Medical Center, 1124 West Carson Street, Torrance, CA 90502, United States of America. Electronic address: megannguyen@westernu.edu.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Trajano', 'Affiliation': 'Department of Emergency Medicine, University of California, Davis, 2315 Stockton Blvd., Sacramento, CA 96817, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tancredi', 'Affiliation': 'Department of Pediatrics, University of California, Davis, 2516 Stockton Blvd., Sacramento, CA 95817, USA. Electronic address: djtancredi@ucdavis.edu.'}, {'ForeName': 'Elmar R', 'Initials': 'ER', 'LastName': 'Aliyev', 'Affiliation': 'Health Economics Department, School of Pharmacy, University of Southern California, 1985 Zonal Avenue, Los Angeles, CA 90089, USA. Electronic address: aliyev@usc.edu.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mooso', 'Affiliation': 'Department of Emergency Medicine, University of California, Davis, 2315 Stockton Blvd., Sacramento, CA 96817, USA. Electronic address: bamooso@ucdavis.edu.'}, {'ForeName': 'Chance', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'Department of Emergency Medicine, University of California, Davis, 2315 Stockton Blvd., Sacramento, CA 96817, USA. Electronic address: cranderson@ucdavis.edu.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ondak', 'Affiliation': 'Department of Emergency Medicine, University of California, Davis, 2315 Stockton Blvd., Sacramento, CA 96817, USA.'}, {'ForeName': 'Nuen', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Division of Biostatistics, University of California, Davis, One Shields Avenue, Davis, CA 95616, USA. Electronic address: matyang@ucdavis.edu.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Division of Infectious Diseases, University of California, Davis, 4150 V Street, Sacramento, CA 95817, USA. Electronic address: stcohen@ucdavis.edu.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Wiedeman', 'Affiliation': 'Department of Pediatrics, University of California, Davis, 2516 Stockton Blvd., Sacramento, CA 95817, USA. Electronic address: jataylorwiedeman@ucdavis.edu.'}, {'ForeName': 'Loren G', 'Initials': 'LG', 'LastName': 'Miller', 'Affiliation': 'Division of Infectious Diseases, UCLA Medical Center, 1000 W. Carson St. Box 466, Torrance, CA 90509, USA. Electronic address: lgmiller@ucla.edu.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.10.017']
1680,33139992,The application of a targeted periprostatic nerve block in transperineal template-guided prostate biopsies.,"Background
Our study aims to evaluate the anesthetic efficacy of multiparametric magnetic resonance imaging/transrectal ultrasound (mpMRI/TRUS) fusion-guided targeted periprostatic nerve block (PNB) for transperineal template-guided prostate biopsy (TTPB).
Methods
The patients who underwent mpMRI/TRUS fusion-guided prostate biopsy from May 2018 to March 2019 were randomized into two groups using a random number table. The intervention group (n=47) and the control group (n=45) received targeted PNB and traditional PNB, respectively. Visual analog scale (VAS) and visual numeric scale (VNS) scores were used to assess the patients' pain and quantify their satisfaction.
Results
The total detection rate for prostate cancer was 45.7%, with a comparable positive rate between the intervention group (42.6%) and the control group (48.9%), which meant there was no significant difference between the groups (P=0.542). Patient age, prostate-specific antigen, prostate volume, suspicious lesions on mpMRI, number of cores, operation time, and biopsy time were comparable between the groups. The VAS scores during biopsy were significantly lower in the intervention group than in the control group [2 (1 to 3) vs . 2 (1 to 4), P=0.019]. Conversely, the VNS scores during biopsy were higher in the intervention group [3 (2 to 4) vs . 3 (2 to 3), P=0.015]. There were no significant differences in the pain scores or the satisfaction scores at 30 min after the procedure between the two groups. There were no significant differences between the groups for complications, such as hematuria, urinary retention, infection, hemospermia, and vasovagal reaction (P>0.05).
Conclusions
Targeted PNB significantly relieved the pain and did not increase the incidence of complications for patients when compared with traditional PNB.",2020,There were no significant differences in the pain scores or the satisfaction scores at 30 min after the procedure between the two groups.,['patients who underwent mpMRI/TRUS fusion-guided prostate biopsy from May 2018 to March 2019'],"['targeted PNB and traditional PNB', 'multiparametric magnetic resonance imaging/transrectal ultrasound (mpMRI/TRUS) fusion-guided targeted periprostatic nerve block (PNB']","['complications, such as hematuria, urinary retention, infection, hemospermia, and vasovagal reaction (P>0.05', 'VAS scores', 'Patient age, prostate-specific antigen, prostate volume, suspicious lesions on mpMRI, number of cores, operation time, and biopsy time', 'pain', 'incidence of complications', 'VNS scores', 'pain scores or the satisfaction scores', 'Visual analog scale (VAS) and visual numeric scale (VNS) scores', 'total detection rate for prostate cancer']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0149707', 'cui_str': 'Hemospermia'}, {'cui': 'C0042420', 'cui_str': 'Vasovagal syncope'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",,0.0501362,There were no significant differences in the pain scores or the satisfaction scores at 30 min after the procedure between the two groups.,"[{'ForeName': 'Xue-Fei', 'Initials': 'XF', 'LastName': 'Ding', 'Affiliation': 'Clinical Medical College, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Luan', 'Affiliation': 'Clinical Medical College, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Clinical Medical College, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Yao-Zong', 'Initials': 'YZ', 'LastName': 'Xu', 'Affiliation': 'Clinical Medical College, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Cheng-Hao', 'Initials': 'CH', 'LastName': 'Guo', 'Affiliation': 'Clinical Medical College, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Liang-Yong', 'Initials': 'LY', 'LastName': 'Zhu', 'Affiliation': 'Clinical Medical College, Yangzhou University, Yangzhou, China.'}]",Quantitative imaging in medicine and surgery,['10.21037/qims-20-369']
1681,33140009,The National Endoscopy Database (NED) Automated Performance Reports to Improve Quality Outcomes Trial (APRIQOT) randomized controlled trial design.,"Background and study aims Colonoscopists with low polyp detection have higher post colonoscopy colorectal cancer incidence and mortality rates. The United Kingdom's National Endoscopy Database (NED) automatically captures patient level data in real time and provides endoscopy key performance indicators (KPI) at a national, endoscopy center, and individual level. Using an electronic behavior change intervention, the primary objective of this study is to assess if automated feedback of endoscopist and endoscopy center-level optimal procedure-adjusted detection KPI (opadKPI) improves polyp detection performance. Methods This multicenter, prospective, cluster-randomized controlled trial is randomizing NHS endoscopy centres to either intervention or control. The intervention is targeted at independent colonoscopists and each center's endoscopy lead. The intervention reports are evidence-based from endoscopist qualitative interviews and informed by psychological theories of behavior. NED automatically creates monthly reports providing an opadKPI, using mean number of polyps, and an action plan. The primary outcome is opadKPI comparing endoscopists in intervention and control centers at 9 months. Secondary outcomes include other KPI and proximal detection measures at 9 and 12 months. A nested histological validation study will correlate opadKPI to adenoma detection rate at the center level. A cost-effectiveness and budget impact analysis will be undertaken. Conclusion If the intervention is efficacious and cost-effective, we will showcase the potential of this learning health system, which can be implemented at local and national levels to improve colonoscopy quality, and demonstrate that an automated system that collects, analyses, and disseminates real-time clinical data can deliver evidence- and theory-informed feedback.",2020,Colonoscopists with low polyp detection have higher post colonoscopy colorectal cancer incidence and mortality rates.,[],['automated feedback of endoscopist and endoscopy center-level optimal procedure-adjusted detection KPI (opadKPI'],"['colonoscopy colorectal cancer incidence and mortality rates', 'National Endoscopy Database (NED', 'KPI and proximal detection measures']",[],"[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.15408,Colonoscopists with low polyp detection have higher post colonoscopy colorectal cancer incidence and mortality rates.,"[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Catlow', 'Affiliation': 'Newcastle University Centre for Cancer - Populations Health Sciences Institute, Newcastle Upon Tyne, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sharp', 'Affiliation': 'Newcastle University Centre for Cancer - Populations Health Sciences Institute, Newcastle Upon Tyne, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Adetayo', 'Initials': 'A', 'LastName': 'Kasim', 'Affiliation': 'Durham University, Wolfson Research Institute of Health and Wellbeing, Newcastle Upon Tyne, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Newcastle University Centre for Cancer - Populations Health Sciences Institute, Newcastle Upon Tyne, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Brookes', 'Affiliation': 'Royal Wolverhampton Hospitals NHS Trust, Gastroenterology, Wolverhamptonm.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, Gastroenterology, North Shields, Tyne and Wear, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'McCarthy', 'Affiliation': 'Northumbria University, Department of Nursing, Midwifery & Health, Newcastle Upon Tyne, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Gray', 'Affiliation': 'Northumbria University, Department of Nursing, Midwifery & Health, Newcastle Upon Tyne, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Falko', 'Initials': 'F', 'LastName': 'Sniehotta', 'Affiliation': 'Newcastle University, Population and Health Sciences Institute, Newcastle Upon Tyne, Tyne and Wear, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Deane', 'Affiliation': 'North Tees and Hartlepool NHL Foundation Trust - Gastroenterology, Stockton on Tees, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Rutter', 'Affiliation': 'North Tees and Hartlepool NHL Foundation Trust - Gastroenterology, Stockton on Tees, United Kingdom of Great Britain and Northern Ireland.'}]",Endoscopy international open,['10.1055/a-1261-3151']
1682,33140023,Peroral endoscopic myotomy (POEM) is more cost-effective than laparoscopic Heller myotomy in the short term for achalasia: economic evaluation from a randomized controlled trial.,"Background and study aims We aimed to perform an economic evaluation of peroral endoscopic myotomy (POEM) and laparoscopic Heller myotomy (LHM) for the treatment of achalasia. Materials and methods An economic cost-utility analysis was carried out over a time horizon of 1 year. Patients with achalasia who were admitted to the gastroenterology outpatient clinic of a public tertiary referral hospital were assigned to undergo POEM or LHM. The monetary amounts were extracted from the intranet of the institution using microcosting. All costs associated with the procedure, hospitalization, clinical follow-up and resolution of therapeutic complications were included. The utility data were measured in quality-adjusted life years (QALYs), which were estimated from the scores of a quality-of-life questionnaire. Results Forty patients (20 POEM patients and 20 LHM patients) were included. The final cost associated with POEM and LHM was US$ 2,619.19 ± 399.53 and US$ 1,696.44 ± 412.21, respectively ( P < 0.001). However, the QALYs in the POEM group (0.434 ± 0.215 vs 0.332 ± 0.222, P = 0.397) were slightly higher than those in the LHM group. The incremental cost-utility ratio (ICUR) suggested that an additional US$ 9,046.41/QALY gained was required when using POEM. Conclusion For the treatment of achalasia in the public health system, POEM appears to be more cost-effective than LHM in the short term.",2020,"However, the QALYs in the POEM group (0.434 ± 0.215 vs 0.332 ± 0.222, P = 0.397) were slightly higher than those in the LHM group. ","['Patients with achalasia who were admitted to the gastroenterology outpatient clinic of a public tertiary referral hospital', 'Forty patients (20 POEM patients and 20 LHM patients) were included']","['POEM or LHM', 'peroral endoscopic myotomy (POEM) and laparoscopic Heller myotomy (LHM', 'LHM', 'Peroral endoscopic myotomy (POEM']","['procedure, hospitalization, clinical follow-up and resolution of therapeutic complications', 'incremental cost-utility ratio (ICUR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014848', 'cui_str': 'Achalasia of esophagus'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C4304942', 'cui_str': 'POEM - Patient-Oriented Eczema Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4304942', 'cui_str': 'POEM - Patient-Oriented Eczema Measure'}, {'cui': 'C4760898', 'cui_str': 'Peroral endoscopic myotomy'}, {'cui': 'C4505238', 'cui_str': 'Laparoscopic Heller Cardiomyotomy'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",40.0,0.0692955,"However, the QALYs in the POEM group (0.434 ± 0.215 vs 0.332 ± 0.222, P = 0.397) were slightly higher than those in the LHM group. ","[{'ForeName': 'Tatiana Morgado', 'Initials': 'TM', 'LastName': 'Conte', 'Affiliation': 'University of São Paulo School of Medicine Hospital das Clínicas, São Paulo, Brazil.'}, {'ForeName': 'Luciana Bertocco de Paiva', 'Initials': 'LBP', 'LastName': 'Haddad', 'Affiliation': 'Department of Transplantation, Gastroenterology Division, University of São Paulo School of Medicine Hospital das Clínicas, São Paulo, Brazil.'}, {'ForeName': 'Igor Braga', 'Initials': 'IB', 'LastName': 'Ribeiro', 'Affiliation': 'Endoscopy, Gastroenterology Division, University of São Paulo School of Medicine Hospital das Clínicas, São Paulo, Brazil.'}, {'ForeName': 'Eduardo Turiani Hourneaux', 'Initials': 'ETH', 'LastName': 'de Moura', 'Affiliation': 'University of São Paulo School of Medicine Hospital das Clínicas, São Paulo, Brazil.'}, {'ForeName': 'Luiz Augusto Carneiro', 'Initials': 'LAC', 'LastName': 'DʼAlbuquerque', 'Affiliation': 'Department of Transplantation, Gastroenterology Division, University of São Paulo School of Medicine Hospital das Clínicas, São Paulo, Brazil.'}, {'ForeName': 'Eduardo Guimarães Hourneaux', 'Initials': 'EGH', 'LastName': 'de Moura', 'Affiliation': 'Endoscopy, Gastroenterology Division, University of São Paulo School of Medicine Hospital das Clínicas, São Paulo, Brazil.'}]",Endoscopy international open,['10.1055/a-1261-3417']
1683,33140215,No effect of a dopaminergic modulation fMRI task by amisulpride and L-DOPA on reward anticipation in healthy volunteers.,"RATIONALE
Dysregulation of dopaminergic neurotransmission, specifically altered reward processing assessed via the reward anticipation in the MID task, plays a central role in the etiopathogenesis of neuropsychiatric disorders.
OBJECTIVES
We hypothesized to find a difference in the activity level of the reward system (measured by the proxy reward anticipation) under drug administration versus placebo, in that amisulpride reduces, and L-DOPA enhances, its activity.
METHODS
We studied the influence of dopamine agonist L-DOPA and the antagonist amisulpride on the reward system using functional magnetic resonance imaging (fMRI) during a monetary incentive delay (MID) task in n = 45 healthy volunteers in a randomized, blinded, cross-over study.
RESULTS
The MID paradigm elicits strong activation in reward-dependent structures (such as ventral striatum, putamen, caudate, anterior insula) during reward anticipation. The placebo effect demonstrated the expected significant blood oxygen level-dependent activity in reward-dependent brain regions. Neither amisulpride nor L-DOPA led to significant changes in comparison with the placebo condition. This was true for whole-brain analysis as well as analysis of a pre-defined nucleus accumbens region-of-interest mask.
CONCLUSION
The present results cast doubt on the sensitivity of reward anticipation contrast in the MID task for assessing dopamine-specific changes in healthy volunteers by pharmaco-fMRI. While our task was not well-suited for detailed analysis of the outcome phase, we provide reasonable arguments that the lack of effect in the anticipation phase is not due to an inefficient task but points to unexpected behavior of the reward system during pharmacological challenge. Group differences of reward anticipation should therefore not be seen as simple representatives of dopaminergic states.",2020,Neither amisulpride nor L-DOPA led to significant changes in comparison with the placebo condition.,"['healthy volunteers', 'n = 45 healthy volunteers']","['amisulpride and L-DOPA', 'dopamine agonist L-DOPA and the antagonist amisulpride', 'amisulpride', 'placebo', 'functional magnetic resonance imaging (fMRI']","['blood oxygen level-dependent activity in reward-dependent brain regions', 'activity level of the reward system']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",45.0,0.118447,Neither amisulpride nor L-DOPA led to significant changes in comparison with the placebo condition.,"[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Grimm', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University Frankfurt am Main, Frankfurt, Germany. oliver.grimm@kgu.de.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Nägele', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Küpper-Tetzel', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'de Greck', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Plichta', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University Frankfurt am Main, Frankfurt, Germany.'}]",Psychopharmacology,['10.1007/s00213-020-05693-8']
1684,33136254,"Impact of pharmacist-led educational interventions on asthma control and adherence: single-blind, randomised clinical trial.","Background Asthma is an important cause of morbidity and mortality worldwide. Education is a critical component in the management of asthma. Objective This study sought to assess the impact of pharmacist-led educational interventions on asthma control and adherence. Setting Tertiary Hospitals in Nigeria Method This was a single-blind, three-arm, prospective, randomised, controlled, parallel-group study conducted in the Respiratory Units of the University of Nigeria Teaching Hospital, Enugu State and the Lagos University Teaching Hospital, Lagos State between March 2016 and September 2017. The three arms were: Usual Care, Individual Intervention, Caregiver-assisted Intervention (1:1:1 ratio). The Intervention arms received education for 6 months while the Usual Care arm received no education. The Asthma Control Test and the 8-item Morisky Medication Adherence Scale were filled at baseline, 3 months, and 6 months after baseline. Data were analyzed using the IBM SPSS Version 25.0 with statistical significance set as P < 0.05. Main outcome measure Asthma control and adherence. Results Seventy-eight (78) asthma patients participated; thirty-nine (39) per hospital; thirteen (13) in each arm. The Individual Intervention arm possessed significantly better asthma control compared to Usual Care at 3 months (21.42 Vs. 18.85; P = 0.004, t = 3.124, df = 25, 95% confidence interval = 0.88 - 4.28) and 6 months (21.81 Vs. 19.58; P = 0.003, t = 3.259, df = 25, 95% confidence interval = 0.82 - 3.64). The Individual Intervention arm also possessed significantly better adherence compared to Usual Care at 3 months (6.81 Vs. 4.94; P = 0.001, t = 3.706, df = 25, 95% confidence interval = 0.83 - 2.90) and 6 months (7.28 Vs. 5.13; P < 0.001, t = 4.094, df = 25, 95% confidence interval = 1.07 -3.24). The Caregiver-assisted Interventions had no significant improvement in asthma control and adherence. Conclusion The individualized educational interventions produced better improvements in asthma control and adherence.",2020,The Individual Intervention arm possessed significantly better asthma control compared to Usual Care at 3 months (21.42 Vs.,"['Setting Tertiary Hospitals in Nigeria', 'Results Seventy-eight (78', 'asthma patients participated; thirty-nine (39) per hospital; thirteen (13) in each arm', 'Respiratory Units of the University of Nigeria Teaching Hospital, Enugu State and the Lagos University Teaching Hospital, Lagos State between March 2016 and September 2017']","['Usual Care, Individual Intervention, Caregiver-assisted Intervention', 'pharmacist-led educational interventions', 'individualized educational interventions', 'education for 6\xa0months while the Usual Care arm received no education']","['asthma control and adherence', '8-item Morisky Medication Adherence Scale', 'Asthma control and adherence']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.104162,The Individual Intervention arm possessed significantly better asthma control compared to Usual Care at 3 months (21.42 Vs.,"[{'ForeName': 'Kosisochi C', 'Initials': 'KC', 'LastName': 'Amorha', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka, Enugu State, PMB 410001, Nigeria. kosisochi.amorha@unn.edu.ng.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Okonta', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka, Enugu State, PMB 410001, Nigeria.'}, {'ForeName': 'Chinwe V', 'Initials': 'CV', 'LastName': 'Ukwe', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka, Enugu State, PMB 410001, Nigeria.'}]",International journal of clinical pharmacy,['10.1007/s11096-020-01187-x']
1685,33136281,Do post-operative phone calls enhance family satisfaction and outcomes after outpatient pediatric urological surgeries? A prospective study.,"INTRODUCTION
This study assesses whether post-operative check-in phone calls (POPC) performed within 48 h of outpatient pediatric urological surgeries by a non-medical professional (NMP) would increase patient/family satisfaction and minimize extraneous resource use by increasing email/telephone communication, while reducing emergency department (ED) visits within 30 days of that procedure.
METHODS
Families of patients undergoing ambulatory pediatric urology surgeries were enrolled over 8 weeks. Group 1 did not receive POPC. Group 2 received a POPC within 48 h of their operation by a NMP. Both groups received a phone-call survey 2 weeks after surgery to assess families' perioperative satisfaction.
RESULTS
In total, 74 families were enrolled (Group 1 = 44, Group 2 = 31). The response rates to phone surveys for Groups 1 and 2 were 59.1% and 77.4%, respectively. POPC did not improve perioperative satisfaction, nor did it significantly promote the use of nursing email/telephone communication (19.2% vs. 4.2%, p = 0.128) or reduce ED visits (15.4% vs. 0.0%, p = 0.111). However, all families in Group 2 thought POPC was timed appropriately and 79.1% perceived it to be helpful in reducing post-operative anxiety.
CONCLUSION
POPC by a NMP within 48 h of surgery may not affect perioperative satisfaction of families of patients undergoing same-day pediatric urology surgery but may have an impact in reducing post-operative anxiety.",2020,"POPC did not improve perioperative satisfaction, nor did it significantly promote the use of nursing email/telephone communication (19.2% vs. 4.2%, p = 0.128) or reduce ED visits (15.4% vs. 0.0%, p = 0.111).","['74 families were enrolled (Group 1\u2009=\u200944, Group 2\u2009=\u200931', 'Families of patients undergoing ambulatory pediatric urology surgeries were enrolled over 8\xa0weeks']","['POPC', 'POPC within 48\xa0h of their operation by a NMP', 'post-operative check-in phone calls (POPC) performed within 48\xa0h of outpatient pediatric urological surgeries by a non-medical professional (NMP']","['perioperative satisfaction', 'use of nursing email/telephone communication', 'reduce ED visits', 'response rates to phone surveys']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",74.0,0.0478471,"POPC did not improve perioperative satisfaction, nor did it significantly promote the use of nursing email/telephone communication (19.2% vs. 4.2%, p = 0.128) or reduce ED visits (15.4% vs. 0.0%, p = 0.111).","[{'ForeName': 'Jin K', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Division of Urology, Department of Surgery, University of Toronto, Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada. jjk.kim@mail.utoronto.ca.'}, {'ForeName': 'Min Joon', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': 'Division of Urology, Department of Surgery, University of Toronto, Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Chua', 'Affiliation': 'Division of Urology, Department of Surgery, University of Toronto, Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Ming', 'Affiliation': 'Division of Urology, Department of Surgery, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Armando J', 'Initials': 'AJ', 'LastName': 'Lorenzo', 'Affiliation': 'Division of Urology, Department of Surgery, University of Toronto, Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Walid A', 'Initials': 'WA', 'LastName': 'Farhat', 'Affiliation': 'Department of Urology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Darius J', 'Initials': 'DJ', 'LastName': 'Bagli', 'Affiliation': 'Division of Urology, Department of Surgery, University of Toronto, Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Papanikolaou', 'Affiliation': 'Division of Urology, Department of Surgery, University of Toronto, Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Koyle', 'Affiliation': 'Division of Urology, Department of Surgery, University of Toronto, Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada.'}]",Pediatric surgery international,['10.1007/s00383-020-04770-5']
1686,33136301,Tailored music listening intervention to reduce sleep disturbances in older adults with dementia: Research protocol.,"Sleep disruption in older adults living with Alzheimer's disease and related dementias (ADRD) is debilitating and contributes to increased institutionalization, reduced cognitive function, and accelerated disease progression. Furthermore, sleep disruption is linked to poor health outcomes in caregivers, such as decreased quality of life and increased caregiver burden. Given the potentially harmful side effects of pharmacologic treatment, nonpharmacologic approaches, such as music, may provide a safer alternative to reducing sleep disruption in this vulnerable population. A growing body of literature suggests that calming tailored music may improve sleep quality in older adults with memory loss, but its efficacy has not been demonstrated in older adults with ADRD in the community, where most older adults with ADRD live. If shown to be feasible and acceptable, tailored music interventions can then be tested for efficacy in reducing sleep disruption. This protocol details a wait-list randomized controlled trial (NCT04157244), the purpose of which is to test the feasibility, acceptability, and examine the preliminary efficacy of a tailored music listening intervention in older adults with ADRD who report sleep disruption. Music selections will be tailored to the music genre preferences of older adults with ADRD and account for known sleep-inducing properties. The feasibility of processes that is key to the success of the subsequent study will be examined. Preliminary efficacy of the intervention will be assessed using objective (actigraphy) and subjective (proxy-reported) sleep quality measures. In addition, qualitative data will be solicited, examining the acceptability and satisfaction with the intervention by individuals with ADRD.",2020,"Furthermore, sleep disruption is linked to poor health outcomes in caregivers, such as decreased quality of life and increased caregiver burden.","['older adults with ADRD', 'older adults with memory loss', ""older adults living with Alzheimer's disease and related dementias (ADRD"", 'older adults with dementia', 'older adults with ADRD live', 'older adults with ADRD who report sleep disruption']","['tailored music listening intervention', 'Tailored music listening intervention']","['acceptability and satisfaction', 'objective (actigraphy) and subjective (proxy-reported) sleep quality measures', 'sleep disturbances', 'Sleep disruption', 'sleep quality']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0002622', 'cui_str': 'Amnesia'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",,0.086478,"Furthermore, sleep disruption is linked to poor health outcomes in caregivers, such as decreased quality of life and increased caregiver burden.","[{'ForeName': 'Darina V', 'Initials': 'DV', 'LastName': 'Petrovsky', 'Affiliation': 'Behavioral Health Sciences Department, University of Pennsylvania School of Nursing, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nalaka S', 'Initials': 'NS', 'LastName': 'Gooneratne', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Joke', 'Initials': 'J', 'LastName': 'Bradt', 'Affiliation': 'College of Nursing and Health Professions, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': 'College of Nursing and Health Professions, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Hodgson', 'Affiliation': 'Behavioral Health Sciences Department, University of Pennsylvania School of Nursing, Philadelphia, Pennsylvania, USA.'}]",Research in nursing & health,['10.1002/nur.22081']
1687,33136314,Impact of a nurse-led intervention on quality of life in patients with chronic non-malignant pain: An open randomized controlled trial.,"AIMS
To determine the effect of a comprehensive nurse-led programme for patients with chronic non-malignant pain, on quality of life, level of pain, anxiety, and depression, as primary outcomes and patients' satisfaction as a secondary end point.
DESIGN
An open-label randomized controlled trial was carried out.
METHODS
The experimental group received both a nurse-led intervention on healthy lifestyles, education on self-esteem, pain awareness, communication, and relaxation techniques. The control group received usual care. Quality of life, level of pain, anxiety, and depression were the main outcomes. Data were obtained at baseline, immediately after the intervention, and 6 and 9 months. The study was carried out from 2015-2017.
RESULTS
The sample was composed of 279 patients. At 9 months, the effect size (non-parametric effect size statistic A) favoured the intervention group for SF-36 mental health score (A = 0.79; 95% CI: 0.73-0.85), anxiety (A = 0.58; 95% CI: 0.51-0.65), pain intensity (A = 0.57; 95% CI: 0.51-0.64), and depression (A = 0.58; 95% CI: 0.51-0.65). Smaller differences were found on physical scores between the intervention and the usual care group. Patients showed a high level of satisfaction with the introduced intervention.
CONCLUSION
A comprehensive nurse-led programme for patients with chronic non-malignant pain has a positive impact on their quality of life, level of pain, and mental health.
IMPACT
Studies have reported that the problem of chronic pain is not optimally controlled. A structured nurse-led programme has been tested to facilitate healthy behaviours to help patients manage their chronic pain and to provide them with the necessary tools for their self-care. This nurse-led intervention improved their mental health and decreased their level of pain.",2020,"A comprehensive nurse-led programme for patients with chronic non-malignant pain has a positive impact on their quality of life, level of pain, and mental health.
","['279 patients', 'patients with chronic non-malignant pain', '2015-2017']","['nurse-led intervention', 'comprehensive nurse-led programme', 'usual care', 'nurse-led intervention on healthy lifestyles, education on self-esteem, pain awareness, communication, and relaxation techniques']","['physical scores', 'SF-36 mental health score', 'level of pain', 'pain intensity', 'Quality of life, level of pain, anxiety, and depression', 'anxiety ', 'quality of life, level of pain, anxiety, and depression', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0035029', 'cui_str': 'Relaxation technique'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.111389,"A comprehensive nurse-led programme for patients with chronic non-malignant pain has a positive impact on their quality of life, level of pain, and mental health.
","[{'ForeName': 'Ángeles', 'Initials': 'Á', 'LastName': 'Morales-Fernández', 'Affiliation': 'Agencia Sanitaria Costa del Sol, Marbella, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Jimenez-Martín', 'Affiliation': 'Agencia Sanitaria Costa del Sol, Marbella, Spain.'}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Morales-Asencio', 'Affiliation': 'Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Vergara-Romero', 'Affiliation': 'Agencia Sanitaria Costa del Sol, Marbella, Spain.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Mora-Bandera', 'Affiliation': 'Agencia Sanitaria Costa del Sol, Marbella, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Aranda-Gallardo', 'Affiliation': 'Agencia Sanitaria Costa del Sol, Marbella, Spain.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Canca-Sanchez', 'Affiliation': 'Agencia Sanitaria Costa del Sol, Marbella, Spain.'}]",Journal of advanced nursing,['10.1111/jan.14608']
1688,33130570,Exercise training in the treatment of paroxysmal atrial fibrillation: study protocol of the Cologne ExAfib Trial.,"INTRODUCTION
Atrial fibrillation (AF) is the most common form of cardiac arrhythmia and is associated with a number of comorbidities such as coronary artery disease and heart failure. While physical activity is already implemented in current international guidelines for the prevention and treatment of AF, the precise role of different types of exercise in the management of AF remains to be elucidated. The primary aim of the Cologne ExAfib Trial is to assess the feasibility and safety of different exercise modes in patients diagnosed with paroxysmal AF. Secondary outcomes include assessments of physical function, AF burden, quality of life and inflammation, as well as morphological and cardiac adaptations.
METHODS AND ANALYSIS
The study opened for recruitment in September 2019. In the initial pilot phase of this four-armed randomised controlled trial, we aim to enrol 60 patients between 60 years and 80 years of age with paroxysmal AF. After screening and pretesting, patients are randomised into one of the following groups: high-intensity interval training (4×4 min at 75%-85% peak power output (PPO)), moderate-intensity continuous training (25 min at 55%-65% PPO), strength training (whole body, 3 sets of 6-12 repetitions at 70%-90% one repetition maximum [1RM]) or a usual-care control group. Training is performed two times per week for 12 weeks. If the feasibility and safety can be confirmed through the initial pilot phase, the recruitment will be continued and powered for a clinical endpoint.Feasibility and safety are assessed by measures of recruitment and completion, programme tolerance and adherence as well as reported adverse events, including hospitalisation rates. Secondary endpoints are assessed by measures of peak oxygen consumption and the 1RM of selected muscle groups, questionnaires concerning quality of life and AF burden, serum blood samples for the analysis of C reactive protein, interleukin-6, tumour necrosis factor alpha and N-terminal pro-brain natriuretic peptide concentrations and ultrasound for muscle and heart morphology as well as cardiac function.
ETHICS AND DISSEMINATION
Ethics approval was obtained from the ethics committee of the German Sport University Cologne (No.: 175/2018). All procedures performed in studies involving human participants are in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. Manuscripts will be written based on international authorship guidelines. No professional writers will be commissioned for manuscript drafting. The findings of this study will be published in peer-reviewed journals and presented at leading exercise and medicine conferences TRIAL REGISTRATION NUMBER: The study is registered both at the German and at the WHO trial registers (DRKS00016637); Pre-results.",2020,"Feasibility and safety are assessed by measures of recruitment and completion, programme tolerance and adherence as well as reported adverse events, including hospitalisation rates.","['paroxysmal atrial fibrillation', 'patients diagnosed with paroxysmal AF', 'enrol 60 patients between 60 years and 80 years of age with paroxysmal AF', 'German Sport University Cologne']","['high-intensity interval training (4×4\u2009min at 75%-85%\u2009peak power output (PPO)), moderate-intensity continuous training (25\u2009min at 55%-65%\u2009PPO), strength training (whole body, 3 sets of 6-12 repetitions at 70%-90%\u2009one repetition maximum [1RM]) or a usual-care control group', 'Exercise training']","['peak oxygen consumption and the 1RM of selected muscle groups, questionnaires concerning quality of life and AF burden, serum blood samples for the analysis of C reactive protein, interleukin-6, tumour necrosis factor alpha and N-terminal pro-brain natriuretic peptide concentrations and ultrasound for muscle and heart morphology as well as cardiac function', 'Feasibility and safety', 'assessments of physical function, AF burden, quality of life and inflammation, as well as morphological and cardiac adaptations', 'feasibility and safety', 'hospitalisation rates']","[{'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032956', 'cui_str': 'Preferred Provider Organization'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",60.0,0.11517,"Feasibility and safety are assessed by measures of recruitment and completion, programme tolerance and adherence as well as reported adverse events, including hospitalisation rates.","[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Zacher', 'Affiliation': 'Department of Preventive and Rehabilitative Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University, Cologne, Germany j.zacher@dshs-koeln.de.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Dillschnitter', 'Affiliation': 'Department of Preventive and Rehabilitative Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University, Cologne, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Freitag', 'Affiliation': 'Department of Molecular and Cellular Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University, Cologne, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Kreutz', 'Affiliation': 'IST University of Applied Sciences, Dusseldorf, Germany.'}, {'ForeName': 'Birna', 'Initials': 'B', 'LastName': 'Bjarnason-Wehrens', 'Affiliation': 'Department of Preventive and Rehabilitative Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University, Cologne, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Bloch', 'Affiliation': 'Department of Molecular and Cellular Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University, Cologne, Germany.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Predel', 'Affiliation': 'Department of Preventive and Rehabilitative Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University, Cologne, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Schumann', 'Affiliation': 'Department of Molecular and Cellular Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University, Cologne, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-040054']
1689,33130645,DIVERSITY OF TREATMENT OF GENERALIZED PERIODONTAL DISEASES IN PATIENTS WITH ANOREXIA NERVOSA.,"Generalized parodontal diseases (GPD) consistently occupy one of the leading places in the structure of dental diseases. Early diagnosis of the initial degree of generalized parodontitis (GP) is an effective way of secondary prevention. This is due to the complexity of understanding the etio-pathogenetic mechanisms of the development generalized parodontal diseases (GPD) and the high association of them with a number of diseases of the internal organs and systems with common points of contact between interdependence and mutual influence, in particular with anorexia nervosa (AN). The aim of this research was to develop a protocol for the treatment of GP in patients with AN. The object - 60 patients (mean age 26±3.8 years), with a diagnosis of GP, I-II degree, chronic, and AN, restrictive, which by simple randomization were divided into three groups (randomized by sex, age of patients, underlying and comorbidy diagnosis) to study the clinical effectiveness of our proposed method. Clinical, radiological, hygienic, immunological, biochemical, psychological and statistical methods were used. Conclusions. Thus, as a result of the proposed treatment protocol, the largest number of satisfactory treatment results was observed in group III patients (85.0±8.0%) with the inclusion of drugs that affect the pathogenetic mechanisms of the disease, including normalization of local immunity, markers of decline oxidative-antioxidant stress, radiological data of normalization of bone tissue of the alveolar process, a tendency to reduce microbial and tissue sensitization.",2020,"Thus, as a result of the proposed treatment protocol, the largest number of satisfactory treatment results was observed in group III patients (85.0±8.0%) with the inclusion of drugs that affect the pathogenetic mechanisms of the disease, including normalization of local immunity, markers of decline oxidative-antioxidant stress, radiological data of normalization of bone tissue of the alveolar process, a tendency to reduce microbial and tissue sensitization.","['60 patients (mean age 26±3.8 years), with a diagnosis of GP, I-II degree, chronic, and AN, restrictive, which by simple randomization', 'patients with AN']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",[],[],,0.0138487,"Thus, as a result of the proposed treatment protocol, the largest number of satisfactory treatment results was observed in group III patients (85.0±8.0%) with the inclusion of drugs that affect the pathogenetic mechanisms of the disease, including normalization of local immunity, markers of decline oxidative-antioxidant stress, radiological data of normalization of bone tissue of the alveolar process, a tendency to reduce microbial and tissue sensitization.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Antonenko', 'Affiliation': 'Bogomolets National Medical University, Institute Postgraduate Education, Department of Dentistry, Kyiv, Ukraine.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Reshetnyk', 'Affiliation': 'Bogomolets National Medical University, Institute Postgraduate Education, Department of Dentistry, Kyiv, Ukraine.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Zelinskaya', 'Affiliation': 'Bogomolets National Medical University, Institute Postgraduate Education, Department of Dentistry, Kyiv, Ukraine.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Stolyar', 'Affiliation': 'Bogomolets National Medical University, Institute Postgraduate Education, Department of Dentistry, Kyiv, Ukraine.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Revych', 'Affiliation': 'Bogomolets National Medical University, Institute Postgraduate Education, Department of Dentistry, Kyiv, Ukraine.'}]",Georgian medical news,[]
1690,33130650,THE EFFICACY OF ENDOBRONCHIAL VALVE THERAPY IN COMPLEX TREATMENT OF BRONCHO-PLEURAL FISTULAS.,"The aim of our investigation was the assessment of the efficacy of endobronchial valve (EBV) therapy in the complex treatment BPF. The presented study has been carried out in several centers of Georgia (basically in the National Center for Tuberculosis and Lung Diseases). The study group was selected from 30 patients with BPF, who underwent endobronchial valve therapy and signed the informed consent to participate in the study. The corresponding control group was selected from 28 patients with BPF, who underwent conservative therapy by multiple thoracocentesis, chest tube insertion and also surgery and signed the informed consent to participate in the study. EBV therapy has been carried out by combined using the rigid (Friedel) and flexible (Olympus and Pentax) bronchoscopes. EBV therapy has been performed by valves of Medlung Ltd.The quality of life in study and control groups has been studied by the Saint George Respiratory Questionnaire (SGRQ). Statistical analysis performed by software SPSS 22.0. BPF closure after EBV intervention in the study group was in 28 cases from 30 and in 19 cases from 28 in the control group. Respectively the relapse cases after EBV intervention or surgery showed that 2 cases (6.7%) were identified in the study group and 9 cases (32.14%) - in the control group. Difference between groups was statistically significant (χ2=6.1163; p=0.0134). The duration of the pre-surgery period in the study group was significantly lower, 0.89 (SD - 1.45) days compared to the control group, 11.04 (SD -17.0) days. The mean value of hospital delay after EBV intervention was 8.0 (SD - 14.1) days, the corresponding value in the control group was 36.9 (SD - 47.4) days (the difference was significant p=0.0023). The mean duration of the chest tube insertion in the study group after EBV therapy - 2.6 (SD - 1.7) days. Analogous values in control group was 18.4 (SD - 20.2) days (p=0.0001). The assessment of the quality of life by SGRQ in study and control groups showed that the total SGRQ score was decreased significantly during 6 months from 65.4 to 42.3 (p<0.001), i.e. by 23.1. The total SGRQ score in the control group was not decreased significantly during 6 months (from 63.6 to 58.4, p=NS). The dynamics for symptom domain was also significant -27.6 (p=0.008), for activity domain -31.5 (p<0.001), for impact domain -17.0 (p=0.011). EBV therapy revealed high efficacy in the treatment of BPF. Compared to traditional methods, such as conservative therapy (thoracentesis, chest tube insertion) and surgery it was expressed by significantly lower frequency of relapses, lower duration of chest tube insertion, and lower duration of hospital delay.",2020,"The dynamics for symptom domain was also significant -27.6 (p=0.008), for activity domain -31.5 (p<0.001), for impact domain -17.0 (p=0.011).","['28 cases from 30 and in 19 cases from 28 in the control group', '28 patients with BPF, who underwent', 'several centers of Georgia (basically in the National Center for Tuberculosis and Lung Diseases', '30 patients with BPF, who underwent endobronchial valve therapy and signed the informed consent to participate in the study']","['endobronchial valve (EBV) therapy', 'EBV therapy', 'conservative therapy by multiple thoracocentesis, chest tube insertion and also surgery and signed the informed consent']","['total SGRQ score', 'mean value of hospital delay after EBV intervention', 'frequency of relapses, lower duration of chest tube insertion, and lower duration of hospital delay', 'mean duration of the chest tube insertion', 'BPF closure', 'quality of life', 'duration of the pre-surgery period']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017452', 'cui_str': 'Georgia state'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C3880733', 'cui_str': 'Endobronchial valve'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3880733', 'cui_str': 'Endobronchial valve'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0189477', 'cui_str': 'Thoracentesis'}, {'cui': 'C0189476', 'cui_str': 'Insertion of pleural tube drain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3472502', 'cui_str': ""Saint George's respiratory questionnaire score""}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3880733', 'cui_str': 'Endobronchial valve'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0189476', 'cui_str': 'Insertion of pleural tube drain'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",30.0,0.0138443,"The dynamics for symptom domain was also significant -27.6 (p=0.008), for activity domain -31.5 (p<0.001), for impact domain -17.0 (p=0.011).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tchkonia', 'Affiliation': 'National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Vacharadze', 'Affiliation': 'National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mskhaladze', 'Affiliation': 'National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia.'}]",Georgian medical news,[]
1691,33130658,NEUROLOGICAL DISORDERS AMONG THE USERS OF HOMEMADE ARTISANAL EPHEDRONE PSYCHOSTIMULANTS AND INVESTIGATION OF THIOGAMMA EFFICACY IN THEIR TREATMENT.,"60 patients of the Narcological Clinic ""Neogene"" were enrolled into the study. The following participation criteria were used: a diagnosis of mental and behavioral disorders associated with ephedrone use; withdrawal state. Toxic encephalopathy; age - 20-65 years; gender - male. Patients were selected and diagnosed for the study according to ICD-10 criteria. The study was conducted in compliance with bioethical principles, based on informed consent. The main study group (Group I) consisted of 45 patients and the control group (Group II) - of 15 patients. The study strictly observed anonymity and confidentiality of the participants. Thiogamma drug (alpha-lipoic acid, meglumine salt, manufacturer WÖRWAG PHARMA) with a daily dose of 600 mg was added for a duration of one month, to the standard treatment regimen of the patients of the Group I in both inpatient and outpatient settings. The patients (both inpatient and outpatient) in the Group II were treated with placebo drug along with standard treatment for the same period. Clinico-neurological disorders of the patients were evaluated before and after a one-month therapy course. Neurological examination and Unified Parkinson Disease Rating Scale - UPDSR - were used. Based on the study materials it can be reported that the users of homemade ephedron group psychostimulants (""Jeff"") had neurological disorders, mainly manifested with the symptoms of Parkinson's disease; with well-expressed dystonia, postural instability, pseudobulbar and vegetative syndromes. As a result of the treatment, a decrease in the scores on the UPDSR was observed (improved condition) in patients of both groups, however, the improvement was greater expressed in the patients of Group I where Thiogamma (alpha-lipoic acid meglumine salt) drug was added to the standard treatment protocol. The above results clearly speak to the effectiveness of ""Thiogamma"" in the treatment of neurological disorders caused by the use of homemade psychostimulants (""Jeff"").",2020,"As a result of the treatment, a decrease in the scores on the UPDSR was observed (improved condition) in patients of both groups, however, the improvement was greater expressed in the patients of Group I where Thiogamma (alpha-lipoic acid meglumine salt) drug was added to the standard treatment protocol.","['60 patients of the Narcological Clinic ""Neogene"" were enrolled into the study', 'Patients were selected and diagnosed for the study according to ICD-10 criteria', 'Toxic encephalopathy; age - 20-65 years; gender - male']","['Thiogamma drug (alpha-lipoic acid, meglumine salt, manufacturer WÖRWAG PHARMA', 'placebo']","['UPDSR', 'Clinico-neurological disorders', 'Neurological examination and Unified Parkinson Disease Rating Scale - UPDSR ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0149504', 'cui_str': 'Toxic encephalopathy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0025179', 'cui_str': 'Meglumine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}]",45.0,0.0143153,"As a result of the treatment, a decrease in the scores on the UPDSR was observed (improved condition) in patients of both groups, however, the improvement was greater expressed in the patients of Group I where Thiogamma (alpha-lipoic acid meglumine salt) drug was added to the standard treatment protocol.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Asatiani', 'Affiliation': '1Drug Addiction Clinic ""Neogeni"", Tbilisi, Georgia.'}, {'ForeName': 'Kh', 'Initials': 'K', 'LastName': 'Todadze', 'Affiliation': '2Tbilisi State Medical University; 3Center for Mental Helath and Prevention of addiction, Tbilisi, Georgia.'}]",Georgian medical news,[]
1692,33131199,Favorable effect of sodium-glucose co-transporter-2 inhibitor dapagliflozin on nonalcoholic fatty liver disease compared with pioglitazone.,"AIMS/INTRODUCTION
Sodium-glucose co-transporter-2 (SGLT2) inhibitors, as well as thiazolidines, suppress nonalcoholic fatty liver disease (NAFLD); however, few comparative studies have been reported. Dapagliflozin has demonstrated non-inferiority compared with pioglitazone for glycemic control and superiority regarding weight reduction in patients with type 2 diabetes. We conducted a secondary analysis for the favorable effects of SGLT2 inhibitors for NAFLD.
MATERIALS AND METHODS
In this multicenter, open-label, prospective, randomized, parallel-group comparison trial, patients taking pioglitazone for ≥12 weeks were randomly switched to dapagliflozin or continued pioglitazone for a further 24 weeks. Fatty liver index (FLI), consisting of body mass index, triglycerides, waist circumference, and γ-glutamyl transpeptidase, was used for evaluation of NAFLD.
RESULTS
Fifty-three participants with NAFLD (27 dapagliflozin; 26 pioglitazone) had been included in this analysis. FLI decreased significantly in the dapagliflozin group (48.7 ± 23.4 to 42.1 ± 23.9) compared with the pioglitazone group (49.0 ± 26.1 to 51.1 ± 25.8) (p < 0.01). Multiple linear regression analysis showed that the changes in FLI had significantly positive correlation with changes in HbA1c (p = 0.03) and insulin level (p < 0.01) in the dapagliflozin group.
CONCLUSION
Dapagliflozin may be more beneficial than pioglitazone in patients with NAFLD. Improvements in FLI would be closely related to glycemic control.",2020,Dapagliflozin has demonstrated non-inferiority compared with pioglitazone for glycemic control and superiority regarding weight reduction in patients with type 2 diabetes.,"['patients with NAFLD', 'patients with type 2 diabetes', 'Fifty-three participants with NAFLD (27 dapagliflozin; 26']","['sodium-glucose co-transporter-2 inhibitor dapagliflozin', 'SGLT2 inhibitors', 'dapagliflozin or continued pioglitazone', 'pioglitazone', 'Dapagliflozin', 'Sodium-glucose co-transporter-2 (SGLT2) inhibitors', 'dapagliflozin']","['nonalcoholic fatty liver disease', 'Fatty liver index (FLI), consisting of body mass index, triglycerides, waist circumference, and γ-glutamyl transpeptidase', 'FLI', 'insulin level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}]",53.0,0.043359,Dapagliflozin has demonstrated non-inferiority compared with pioglitazone for glycemic control and superiority regarding weight reduction in patients with type 2 diabetes.,"[{'ForeName': 'Kyu Yong', 'Initials': 'KY', 'LastName': 'Cho', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, North 15 West 7, Kita-ku, Sapporo, 060-8638, Japan.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, North 15 West 7, Kita-ku, Sapporo, 060-8638, Japan.'}, {'ForeName': 'Kazuno', 'Initials': 'K', 'LastName': 'Omori', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, North 15 West 7, Kita-ku, Sapporo, 060-8638, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Takase', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, North 15 West 7, Kita-ku, Sapporo, 060-8638, Japan.'}, {'ForeName': 'Aika', 'Initials': 'A', 'LastName': 'Miya', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, North 15 West 7, Kita-ku, Sapporo, 060-8638, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, North 15 West 7, Kita-ku, Sapporo, 060-8638, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nomoto', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, North 15 West 7, Kita-ku, Sapporo, 060-8638, Japan.'}, {'ForeName': 'Hiraku', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, North 15 West 7, Kita-ku, Sapporo, 060-8638, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Taneda', 'Affiliation': 'Diabetes Center, Manda Memorial Hospital, South 2 West 1, Chuo-ku, Sapporo, 060-0062, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Kurihara', 'Affiliation': 'Kurihara Clinic, Atsubethuchuo 3-5, Atsubetsu-ku, Sapporo, 004-0053, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Aoki', 'Affiliation': 'Aoki Clinic, Nango dori 1, North 1-1, Shiroishi-ku, Sapporo, 003-0023, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, North 15 West 7, Kita-ku, Sapporo, 060-8638, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, North 15 West 7, Kita-ku, Sapporo, 060-8638, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13457']
1693,33135385,Randomized trial of a patient empowerment and cognitive training program for older people with diabetes mellitus and cognitive impairment.,"AIM
To evaluate the effectiveness of a combined patient empowerment program (PEP) and cognitive training (CT) program on improving glycemic control among older subjects with diabetes and cognitive impairment.
METHODS
A prospective single blinded, randomized controlled study was carried out in 139 older patients with diabetes aged ≥65 years with memory complaints and recent glycosylated hemoglobin level of 7-9%. They were randomly assigned to either undergo once-weekly PEP combined with CT for 10 weeks (intervention group, N = 73) or receive no intervention (control group, N = 66). All participants were followed up at months 4 and 12 to examine the immediate and long-term effects on glycemic control, cognition, mood and compliance to drug and diabetes self-management.
RESULTS
The intervention did not significantly reduce glycosylated hemoglobin. The intervention group showed significant progressive improvement in memory over 1 year and executive function improved significantly at month 12. There was no significant change in diabetes self-management activities with the intervention.
CONCLUSIONS
Combination of PEP and CT did not improve glycemic control or self-care activities in older patients with diabetes and memory complaints but was effective in improving cognitive function in the longer term. Geriatr Gerontol Int ••; ••: ••-•• Geriatr Gerontol Int 2020; ••: ••-••.",2020,"CONCLUSIONS
Combination of PEP and CT did not improve glycemic control or self-care activities in older patients with diabetes and memory complaints but was effective in improving cognitive function in the longer term.","['older people with diabetes mellitus and cognitive impairment', 'older subjects with diabetes and cognitive impairment', '139 older patients with diabetes aged ≥65\u2009years with memory complaints and recent glycosylated hemoglobin level of 7-9', 'older patients with diabetes and memory complaints']","['PEP combined with CT for 10\u2009weeks (intervention group, N = 73) or receive no intervention (control', 'patient empowerment and cognitive training program', 'combined patient empowerment program (PEP) and cognitive training (CT) program', 'PEP and CT']","['glycosylated hemoglobin', 'diabetes self-management activities', 'progressive improvement in memory over 1\u2009year and executive function', 'cognitive function', 'glycemic control or self-care activities', 'glycemic control, cognition, mood and compliance to drug and diabetes self-management', 'glycemic control']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]","[{'cui': 'C3853035', 'cui_str': 'Patient Empowerment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",139.0,0.027951,"CONCLUSIONS
Combination of PEP and CT did not improve glycemic control or self-care activities in older patients with diabetes and memory complaints but was effective in improving cognitive function in the longer term.","[{'ForeName': 'Chit-Wai', 'Initials': 'CW', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine & Geriatrics, Caritas Medical Centre, Hospital Authority, Hong Kong.'}, {'ForeName': 'Wai-Tsun William', 'Initials': 'WW', 'LastName': 'O', 'Affiliation': 'Department of Medicine & Therapeutics, Prince of Wales Hospital, Shatin, Hong Kong.'}, {'ForeName': 'Kin-Wai Shirley', 'Initials': 'KS', 'LastName': 'Wong', 'Affiliation': 'Senior Citizens Services, Social Services Department, The Salvation Army Hong Kong & Macau Command, Hong Kong.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Department of Medicine & Therapeutics, Prince of Wales Hospital, Shatin, Hong Kong.'}, {'ForeName': 'Elsie', 'Initials': 'E', 'LastName': 'Hui', 'Affiliation': 'Medicine and Geriatric Unit, Shatin Hospital, Hospital Authority, Hong Kong.'}, {'ForeName': 'Chi-Yui Timothy', 'Initials': 'CT', 'LastName': 'Kwok', 'Affiliation': 'Department of Medicine & Therapeutics, Prince of Wales Hospital, Shatin, Hong Kong.'}]",Geriatrics & gerontology international,['10.1111/ggi.14062']
1694,33135390,Effect of gastric acid-reducing agents on the pharmacokinetics and efficacy of lemborexant.,"Lemborexant is a dual orexin receptor antagonist approved for treating insomnia. As the solubility of lemborexant is pH-sensitive, the impact of the gastric acid-reducing agent (ARA), famotidine, on lemborexant pharmacokinetics was evaluated in a Phase 1 study. Additionally, post hoc analysis of data from Phase 3 studies examined the potential effect of concomitant ARAs on patient-reported/subjective sleep onset latency (sSOL) in subjects with insomnia. Coadministration of lemborexant 10 mg with famotidine decreased the maximum observed concentration by 27% and delayed time of maximum observed concentration by 0.5 hours. Famotidine did not affect overall lemborexant exposure based on comparison of area under the concentration curves. Concomitant ARA use in the Phase 3 studies did not impact the effect of lemborexant on sSOL; the change from baseline during the last 7 nights of 1 month of treatment with lemborexant 10 mg was -17.1 minutes with vs -17.9 minutes without ARAs. Collectively, these results indicate that lemborexant can be coadministered with ARAs.",2020,Famotidine did not affect overall lemborexant exposure based on comparison of area under the concentration curves.,['subjects with insomnia'],"['lemborexant', 'gastric acid-reducing agents', 'famotidine', 'Famotidine', 'Lemborexant']",['subjective sleep onset latency (sSOL'],"[{'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0017119', 'cui_str': 'Gastric acid'}, {'cui': 'C0376446', 'cui_str': 'Reductants'}, {'cui': 'C0015620', 'cui_str': 'Famotidine'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}]",,0.0152684,Famotidine did not affect overall lemborexant exposure based on comparison of area under the concentration curves.,"[{'ForeName': 'Ishani', 'Initials': 'I', 'LastName': 'Landry', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Jagadeesh', 'Initials': 'J', 'LastName': 'Aluri', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Hall', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Dayal', 'Affiliation': 'Eisai Ltd., Hatfield, United Kingdom.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moline', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Reyderman', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}]",Pharmacology research & perspectives,['10.1002/prp2.678']
1695,33135406,Home-Based Multicomponent Intervention Increases Exercise Activity and Improves Body Mass Index: Results of a 5-Year Randomized Trial Among Individuals with Alpha-1 Antitrypsin Deficiency-Associated Lung Disease.,"Background
The Step Forward Study (SFS) was designed to increase exercise activity and improve body mass index (BMI) among individuals with alpha-1 antitrypsin deficiency (AATD)-associated lung disease.
Methods
The SFS is a randomized trial of an intensive distance intervention that was delivered via a series of mailings and teleconferences versus no additional intervention. All participants (n=500) were also enrolled in a disease management program designed for individuals with AATD-associated lung disease who have been prescribed augmentation therapy. The primary outcome was self-reported number of exercise minutes per week. The secondary outcome was body mass index (BMI). Linear mixed model analyses were used to assess the difference in average weekly exercise minutes between the intervention arms over time. T-tests, Signed Rank and Wilcoxon rank-sum tests were used to evaluate changes in BMI between the intervention arms and within each BMI category.
Results
The study included 429 individuals with evaluable primary outcome data. There was a significant effect of intervention on exercise minutes over time (p=0.018). Participants in the intervention group reported an average of 167.14 minutes (SD=10.68) of weekly exercise and those in the standard care group reported 148.31 minutes (SD=10.96). There was a significant difference in BMI change between the intervention (mean BMI decrease 0.74, SD=2.16) and the standard care group (mean BMI decrease 0.27, SD=1.63); p=0.0122.
Conclusion
Individuals who were randomly assigned to the intervention group reported more exercise activity and improvements in BMI over the course of this multicomponent intervention compared to individuals assigned to standard care.",2020,Participants in the intervention group reported an average of 167.14 minutes (SD=10.68) of weekly exercise and those in the standard care group reported 148.31 minutes (SD=10.96).,"['All participants (n=500) were also enrolled in a disease management program designed for individuals with AATD-associated lung disease who have been prescribed augmentation therapy', 'Individuals with Alpha-1 Antitrypsin Deficiency-Associated Lung Disease', '429 individuals with evaluable primary outcome data', 'individuals with alpha-1 antitrypsin deficiency (AATD)-associated lung disease']",['Home-Based Multicomponent Intervention'],"['exercise activity and improvements in BMI', 'Exercise Activity and Improves Body Mass Index', 'exercise activity and improve body mass index (BMI', 'body mass index (BMI', 'BMI change', 'self-reported number of exercise minutes per week']","[{'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0221757', 'cui_str': 'Alpha-1-antitrypsin deficiency'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439230', 'cui_str': 'week'}]",429.0,0.0551014,Participants in the intervention group reported an average of 167.14 minutes (SD=10.68) of weekly exercise and those in the standard care group reported 148.31 minutes (SD=10.96).,"[{'ForeName': 'Radmila', 'Initials': 'R', 'LastName': 'Choate', 'Affiliation': 'College of Public Health, University of Kentucky, Lexington, Kentucky, United States.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Mannino', 'Affiliation': 'College of Public Health, University of Kentucky, Lexington, Kentucky, United States.'}, {'ForeName': 'Kristen E', 'Initials': 'KE', 'LastName': 'Holm', 'Affiliation': 'Department of Medicine, National Jewish Health, Denver, Colorado, United States.'}, {'ForeName': 'Tatsiana', 'Initials': 'T', 'LastName': 'Beiko', 'Affiliation': 'Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, Medical University of South Carolina, Charleston, South Carolina, United States.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Boyd', 'Affiliation': 'AlphaNet, Inc., Coral Gables, Florida, United States.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Sandhaus', 'Affiliation': 'Department of Medicine, National Jewish Health, Denver, Colorado, United States.'}]","Chronic obstructive pulmonary diseases (Miami, Fla.)",['10.15326/jcopdf.8.1.2020.0183']
1696,33135552,Do family meetings for hospitalised palliative care patients improve outcomes and reduce health care costs? A cluster randomised trial.,"BACKGROUND
Family meetings facilitate the exploration of issues and goals of care however, there has been minimal research to determine the benefits and cost implications.
AIMS
To determine: (1) if family caregivers of hospitalised patients referred to palliative care who receive a structured family meeting report lower psychological distress (primary outcome), fewer unmet needs, improved quality of life; feel more prepared for the caregiving role; and receive better quality of end-of-life care; (2) if outcomes vary dependant upon site of care and; (3) the cost-benefit of implementing meetings into routine practice.
DESIGN
Pragmatic cluster randomised trial involving palliative care patients and their primary family caregivers at three Australian hospitals. Participants completed measures upon admission (Time 1); 10 days later (Time 2) and two months after the patient died (Time 3). Regression analyses, health utilisation and process evaluation were conducted.
RESULTS
297 dyads recruited; control ( n = 153) and intervention ( n = 144). The intervention group demonstrated significantly lower psychological distress (Diff: -1.68, p < 0.01) and higher preparedness (Diff: 3.48, p = 0.001) at Time 2. No differences were identified based on quality of end of life care or health utilisation measures.
CONCLUSIONS
Family meetings may be helpful in reducing family caregiver distress and enhancing their preparedness for the caregiving role and it appears they may be conducted without increased hospital health utilisation impacts; although opportunity costs need to be considered in order to routinely offer these as a standardised intervention. Additional health economic examination is also advocated to comprehensively understand the cost-benefit implications.
TRIAL REGISTRATION
Australian and New Zealand Clinical Trials Registry ACTRN12615000200583.",2020,"The intervention group demonstrated significantly lower psychological distress (Diff: -1.68, p < 0.01) and higher preparedness (Diff: 3.48, p = 0.001) at Time 2.","['palliative care patients and their primary family caregivers at three Australian hospitals', '297 dyads recruited; control ( n \u2009=\u2009153) and intervention ( n \u2009=\u2009144', 'family caregivers of hospitalised patients referred to palliative care who receive a structured family meeting report lower psychological distress (primary outcome', 'hospitalised palliative care patients']",[],"['psychological distress', 'health care costs', 'quality of life; feel more prepared for the caregiving role; and receive better quality of end-of-life care; (2) if outcomes vary dependant upon site of care and; (3) the cost-benefit of implementing meetings into routine practice', 'quality of end of life care or health utilisation measures']","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0282415', 'cui_str': 'Congresses'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",[],"[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C4082130', 'cui_str': 'Prepared'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0039548', 'cui_str': 'Terminal care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0337950', 'cui_str': 'Site of care'}, {'cui': 'C0010187', 'cui_str': 'Benefits and Costs'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",297.0,0.166719,"The intervention group demonstrated significantly lower psychological distress (Diff: -1.68, p < 0.01) and higher preparedness (Diff: 3.48, p = 0.001) at Time 2.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hudson', 'Affiliation': ""St Vincent's Hospital Melbourne, Victoria, Australia.""}, {'ForeName': 'Afaf', 'Initials': 'A', 'LastName': 'Girgis', 'Affiliation': 'Centre for Oncology Education and Research Translation, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, The University of New South Wales (UNSW Sydney), NSW, Australia.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': ""St Vincent's Hospital Melbourne, Victoria, Australia.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Philip', 'Affiliation': ""St Vincent's Hospital Melbourne, Victoria, Australia.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Mitchell', 'Affiliation': 'University of Queensland, Herston, Queensland, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Parker', 'Affiliation': 'University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Liew', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Brand', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Le', 'Affiliation': 'Melbourne Health, Parkville, Victoria, Australia.'}, {'ForeName': 'Juli', 'Initials': 'J', 'LastName': 'Moran', 'Affiliation': 'Austin Health, Heidelberg, Victoria, Australia.'}]",Palliative medicine,['10.1177/0269216320967282']
1697,33135577,Delayed potentiation effects on neuromuscular performance after optimal load and high load resistance priming sessions using velocity loss.,"Aim: (i) to compare the effects of two different low-volume resistance priming sessions, where the external load is modified on neuromuscular performance after 6 hours of rest; and (ii) to identify the effects on psychological readiness in participants with resistance training experience. Methods: Eleven participants (Body mass: 77.0±8.9 kg; Body height: 1.76±0.08 m; Half squat repetition maximum: 139.8±22.4 kg) performed the priming session under three experimental conditions in a randomized and cross-over design during the morning. The control (CON) condition: no resistance training, ""optimal load"" (OL) condition: two half-squat sets with a velocity loss of around 20% were performed with the ""optimal load"", and 80% of repetition maximum (80% RM) condition: 2 half-squat sets with a velocity loss of around 20% were performed with the 80% RM. Countermovement jump (CMJ), mean power with OL (MP OL ) and 80% RM (MP 80RM ), and mean velocity with OL (MV OL ) and 80% RM (MV 80RM ) were assessed six hours after the intervention. Subjective readiness was also recorded prior to resistance training and evaluation. Significance was set at p<0.05. Results: CMJ was higher after the 80% RM intervention than CON (p<0.001; Δ=6.5% [3.4-9.5]). MP OL and MV OL seemed to be unaffected by both morning sessions. Higher MP 80RM (p=0.044; Δ=9.7% [4.0-15.6]; d= 0.24[0.10-0.37]) and MV 80RM (p=0.004; Δ=8.1% [3.2-13.3]; d= 0.32[0.13-0.52]) after 80% RM than after CON were observed. No effect was observed on psychological readiness. Conclusions: 80% RM priming session increased CMJ height and the capacity to generate power and velocity under a high-load condition without any effect on psychological readiness.",2020,CMJ was higher after the 80% RM intervention than CON (p<0.001; Δ=6.5% [3.4-9.5]).,"['Eleven participants (Body mass: 77.0±8.9 kg; Body height: 1.76±0.08 m', 'participants with resistance training experience']",[],"['CMJ', 'Countermovement jump (CMJ), mean power with OL (MP OL ) and 80% RM (MP 80RM ), and mean velocity with OL (MV OL ) and 80% RM (MV 80RM ', 'Subjective readiness', 'neuromuscular performance', 'psychological readiness', 'CMJ height', 'MP OL and MV OL']","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",[],"[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",,0.0327157,CMJ was higher after the 80% RM intervention than CON (p<0.001; Δ=6.5% [3.4-9.5]).,"[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'González-García', 'Affiliation': 'Education and Health Faculty. Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Giráldez-Costas', 'Affiliation': 'Education and Health Faculty. Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ruiz-Moreno', 'Affiliation': 'Education and Health Faculty. Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gutiérrez-Hellín', 'Affiliation': 'Exercise and Sport Sciences, Education and Humanities Faculty, Francisco de Vitoria University, UFV, Bulding E, Ctra. M-515 Pozuelo-Majadahonda Km 1,800, 28223, Pozuelo de Alarcón, Madrid.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Romero-Moraleda', 'Affiliation': 'Department of Physical Education, Sport and Human Movement, Autonomous University of Madrid, Madrid, Spain.'}]",European journal of sport science,['10.1080/17461391.2020.1845816']
1698,33135590,Evaluating the Effectiveness of a Brief Mindfulness Activity in University Students With Non-Sicidal Self-Injury Egagement.,"Current theoretical frameworks posit that engagement in non-suicidal self-injury (NSSI) is due to an inability to regulate one's emotions. In turn, mindfulness-based interventions have been shown to enhance emotion regulatory processes in those who engage in NSSI.
OBJECTIVE
The purpose of the present study was to determine whether a brief mindfulness activity was differentially effective at increasing state mindfulness and decreasing stress following a stress induction task in university students with versus without a history of NSSI engagement.
METHOD
The sample consisted of two groups of participants who identified as women: participants with a history of NSSI engagement (NSSI; n = 57 ; M age =20.09, SD = 2.05) and participants without (no-NSSI; n = 87; M age =20.22, SD = 1.94). All participants were asked to complete pre-intervention measures of state mindfulness and stress and were randomly assigned to either a mindfulness activity (body scan) or control task condition. Following the completion of their respective activities, a Stroop stress induction task was conducted and participants completed post-intervention measures of state mindfulness and stress.
RESULTS
Two 3-way mixed ANOVAs (Time X NSSI status X Condition) were conducted and revealed significant time by condition interactions for both state mindfulness, Wilk's Λ = .93, F (1, 140) = 10.70, p = .001, η p 2 = .07, and stress, Wilk's Λ = .97, F (1, 140) = 4.21, p = .04, η p 2 = .03. As such, both groups (NSSI/no-NSSI) demonstrated similar increases in state mindfulness and decreases in stress in response to the brief mindfulness activity following the stress induction. Implications for future research and practice will be discussed. HIGHLIGHTS The brief mindfulness activity effectively increased state mindfulness. The brief mindfulness activity effectively decreased stress. Benefits were experienced similarly among both groups (NSSI/no-NSSI).",2020,"As such, both groups (NSSI/no-NSSI) demonstrated similar increases in state mindfulness and decreases in stress in response to the brief mindfulness activity following the stress induction.","['University Students With Non-Sicidal Self-Injury Egagement', 'participants who identified as women: participants with a history of NSSI engagement (NSSI; n \u2009= \u200957 ; M age =20.09, SD \u2009=\u20092.05) and participants without (no-NSSI; n \u2009=\u200987; M age =20.22, SD \u2009=\u20091.94', 'university students with versus without a history of NSSI engagement']",['mindfulness activity (body scan) or control task condition'],['state mindfulness'],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0154637,"As such, both groups (NSSI/no-NSSI) demonstrated similar increases in state mindfulness and decreases in stress in response to the brief mindfulness activity following the stress induction.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Argento', 'Affiliation': ''}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Simundic', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mettler', 'Affiliation': ''}, {'ForeName': 'Devin J', 'Initials': 'DJ', 'LastName': 'Mills', 'Affiliation': ''}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Heath', 'Affiliation': ''}]",Archives of suicide research : official journal of the International Academy for Suicide Research,['10.1080/13811118.2020.1841052']
1699,33135641,Static stretching program decrease the eccentric peak torque without changing the functional perfomance in healthy adults: A Randomized controlled trial.,,2020,,['healthy adults'],['Static stretching program'],['eccentric peak torque'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",,0.045206,,"[{'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Barbosa', 'Affiliation': 'Physical Therapy Department, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'G A F', 'Initials': 'GAF', 'LastName': 'Dantas', 'Affiliation': 'Physical Therapy Department, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Souza', 'Affiliation': 'Physical Therapy Department, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'W H', 'Initials': 'WH', 'LastName': 'Brito Vieira', 'Affiliation': 'Physical Therapy Department, Federal University of Rio Grande do Norte, Natal, Brazil.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.04.012']
1700,33135644,Neuromuscular electrical stimulation during blood flow restriction promotes altered muscle electrical activity and improves balance in high-performance basketball athletes. Blind randomized clinical trial.,,2020,,['high-performance basketball athletes'],['Neuromuscular electrical stimulation during blood flow restriction'],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",[],,0.107739,,"[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Andrelino de Souza', 'Affiliation': 'Ribeirão Preto Medical School, University of de São Paulo.'}, {'ForeName': 'Natanael Teixeira', 'Initials': 'NT', 'LastName': 'Alves de Sousa', 'Affiliation': 'Ribeirão Preto Medical School, University of de São Paulo.'}, {'ForeName': 'Victor Augusto', 'Initials': 'VA', 'LastName': 'Vivan de Oliveira', 'Affiliation': 'Ribeirão Preto Medical School, University of de São Paulo.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Roberto de Jesus Guirro', 'Affiliation': 'Ribeirão Preto Medical School, University of de São Paulo.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.04.016']
1701,33135650,"Cold water immersion effects on doms, muscle recruitment, dynamic postural control and sleep quality in soccer players: A randomized and blinded study.",,2020,,['soccer players'],[],"['muscle recruitment, dynamic postural control and sleep quality']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}]",[],"[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.122272,,"[{'ForeName': 'Fernanda Bortolo', 'Initials': 'FB', 'LastName': 'Pesenti', 'Affiliation': 'Master and Doctoral Programs in Rehabilitation Sciences - UEL/UNOPAR; Laboratory teaching, research and extension in sports physiotherapy (LAFESP-UEL), Universidade Estadual de Londrina.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Alexandre da Silva', 'Affiliation': ""Master and Doctoral Programs in Rehabilitation Sciences - UEL/UNOPAR; Département des Sciences de la Santé, Programme de physiothérapie de l'université McGill offerten extension à l'UQAC, Saguenay, Québec, Canada; Laboratory of Functional Evaluation and Human Motor Performance, LAFUP, Center for Health Science Research, Universidade Norte do Paraná.""}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Alves da Silva', 'Affiliation': 'Laboratory teaching, research and extension in sports physiotherapy (LAFESP-UEL), Universidade Estadual de Londrina.'}, {'ForeName': 'Ariobaldo', 'Initials': 'A', 'LastName': 'Frisseli', 'Affiliation': 'Department of physical education and sport, Universidade Estadual de Londrina.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'de Souza Guerino Macedo', 'Affiliation': 'Master and Doctoral Programs in Rehabilitation Sciences - UEL/UNOPAR; Laboratory teaching, research and extension in sports physiotherapy (LAFESP-UEL), Universidade Estadual de Londrina.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.04.017']
1702,33140403,"Safety and efficacy of midazolam nasal spray for the treatment of intermittent bouts of increased seizure activity in the epilepsy monitoring unit: A double-blind, randomized, placebo-controlled trial.","OBJECTIVE
Midazolam nasal spray (MDZ-NS) is indicated for acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern, in patients 12 years of age and older with epilepsy. This trial evaluated safety and efficacy of MDZ-NS in patients with epilepsy who were admitted to the epilepsy monitoring unit for seizure characterization/presurgical evaluation.
METHODS
In this randomized, double-blind, placebo-controlled phase 3 trial (P261-301; NCT01999777), eligible patients with ≥2 seizures in the 6-hour window preceding trial medication administration for whom treatment was appropriate based on investigator's judgment were randomized (1:1) to MDZ-NS 5 mg or placebo. Efficacy outcomes were proportion of patients seizure-free for 6 hours after treatment and time to first seizure within 6 hours. Safety and tolerability outcomes included treatment-emergent adverse events (TEAEs).
RESULTS
Sixty-two patients were randomized (MDZ-NS n = 31; placebo n = 31), received trial medication, and completed the trial. A higher proportion of patients on MDZ-NS than placebo were seizure-free for 6 hours following treatment (54.8% vs 38.7%); however, the 16.1% difference was not statistically significant (P = .1972). The Kaplan-Meier curve of time to first seizure showed separation of both groups in favor of MDZ-NS from ~1.5 hours post-dose and throughout the 6-hour Treatment phase. Median time to first seizure was not estimable for MDZ-NS (>50% of patients had no seizure) and 3.9 hours for placebo (P = .1388). TEAEs with MDZ-NS were generally comparable to those with placebo. There were no deaths, serious TEAEs, or discontinuations due to TEAEs.
SIGNIFICANCE
Although the observed treatment difference may be clinically meaningful, statistical significance was not demonstrated. Results suggest that MDZ-NS 5 mg may provide improvement over placebo, with efficacy maintained for ≥6 hours post-dose. MDZ-NS was well tolerated in this population.",2020,The Kaplan-Meier curve of time to first seizure showed separation of both groups in favor of MDZ-NS from ~1.5 hours post-dose and throughout the 6-hour Treatment phase.,"['Sixty-two patients were', ""eligible patients with ≥2 seizures in the 6-hour window preceding trial medication administration for whom treatment was appropriate based on investigator's judgment"", 'patients with epilepsy who were admitted to the epilepsy monitoring unit for seizure characterization/presurgical evaluation', 'n\xa0', 'patients 12\xa0years of age and older with epilepsy']","['randomized (MDZ-NS', 'MDZ-NS 5\xa0mg or placebo', 'MDZ-NS', 'Midazolam nasal spray (MDZ-NS', 'placebo', 'midazolam nasal spray']","['seizure-free', 'Safety and tolerability outcomes included treatment-emergent adverse events (TEAEs', 'Safety and efficacy', 'Median time to first seizure', 'proportion of patients seizure-free for 6\xa0hours after treatment and time to first seizure', 'seizure activity']","[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C5140640', 'cui_str': 'Midazolam Nasal Spray [Nayzilam]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",62.0,0.641541,The Kaplan-Meier curve of time to first seizure showed separation of both groups in favor of MDZ-NS from ~1.5 hours post-dose and throughout the 6-hour Treatment phase.,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Spencer', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Saurabh R', 'Initials': 'SR', 'LastName': 'Sinha', 'Affiliation': 'Department of Neurology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Choi', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA.'}, {'ForeName': 'Jody M', 'Initials': 'JM', 'LastName': 'Cleveland', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Aliceson', 'Initials': 'A', 'LastName': 'King', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA.'}, {'ForeName': 'Tze-Chiang', 'Initials': 'TC', 'LastName': 'Meng', 'Affiliation': 'Proximagen, Plymouth, MN, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Pullman', 'Affiliation': 'Proximagen, Plymouth, MN, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Sequeira', 'Affiliation': 'Proximagen, Plymouth, MN, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Van Ess', 'Affiliation': 'Proximagen, Plymouth, MN, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Wheless', 'Affiliation': ""University of Tennessee Health Science Center & Le Bonheur Children's Hospital, Memphis, TN, USA.""}]",Epilepsia,['10.1111/epi.16704']
1703,33140428,Healing of donor sites of connective tissue grafts harvested by the single incision technique. A randomized clinical trial evaluating the use of collagen hemostatic sponge with or without sutures.,"BACKGROUND
The aim of this study was to evaluate the effect of suturing on the early wound healing of donor sites of subepithelial connective tissue grafts (SCTG), harvested by the single incision technique (SIT), following the application of a collagen sponge METHODS: : Thirty-six patients were randomized to receive a collagen sponge with or without sutures in the palatal donor sites following connective tissue grafting via the SIT. Outcome variables were: Early healing index (EHI) at 7, 14 and 30 days, self-reported pain using a visual analogue scale (VAS) recorded on the 0-100 scale at 7 and 14 days, and immediate and delayed bleeding.
RESULTS
No significant differences were found between groups at baseline. EHI index showed no differences between groups in all-time intervals. Eight subjects from suture group (SG) and 10 from no suture group (nSG) showed complete wound closure at day 14 (P > 0.05) and at 30 th day, complete closure was observed in 35 out of 36 patients. Four subjects from the SG and three from the nSG had immediate bleeding (p > 0.05), while delayed bleeding was observed in two subjects from the SG and three from the nSG during the first week of healing (P > 0.05). No differences were found in VAS scale between groups (SG: 36.2 ± 24.8; nSG: 21.5 ± 24.2, P > 0.05).
CONCLUSION
It can be concluded that when a collagen sponge is placed in palatal donor areas of SCTG harvest by means of the SIT (incision length of ≈ 15mm), sutured and non-sutured sites display similar early wound healing outcomes and patient-reported outcomes. This article is protected by copyright. All rights reserved.",2020,"Four subjects from the SG and three from the nSG had immediate bleeding (p > 0.05), while delayed bleeding was observed in two subjects from the SG and three from the nSG during the first week of healing (P > 0.05).",[' : Thirty-six patients'],"['collagen hemostatic sponge with or without sutures', 'subepithelial connective tissue grafts (SCTG), harvested by the single incision technique (SIT', 'no suture group (nSG', 'collagen sponge with or without sutures in the palatal donor sites following connective tissue grafting via the SIT']","['VAS scale', 'Early healing index (EHI) at 7, 14 and 30 days, self-reported pain using a visual analogue scale (VAS) recorded on the 0-100 scale at 7 and 14 days, and immediate and delayed bleeding', 'EHI index', 'immediate bleeding', 'complete wound closure', 'delayed bleeding']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0032699', 'cui_str': 'Phylum Porifera'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}]",36.0,0.021246,"Four subjects from the SG and three from the nSG had immediate bleeding (p > 0.05), while delayed bleeding was observed in two subjects from the SG and three from the nSG during the first week of healing (P > 0.05).","[{'ForeName': 'Schinini', 'Initials': 'S', 'LastName': 'Guillermo', 'Affiliation': 'Department of Postgraduate Periodontics, Maimónides University, Buenos Aires, Argentina.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Sales', 'Affiliation': 'Department of Postgraduate Periodontics, Maimónides University, Buenos Aires, Argentina.'}, {'ForeName': 'Mariel V', 'Initials': 'MV', 'LastName': 'Gómez', 'Affiliation': 'Department of Postgraduate Periodontics, Maimónides University, Buenos Aires, Argentina.'}, {'ForeName': 'Hugo J', 'Initials': 'HJ', 'LastName': 'Romanelli', 'Affiliation': 'Department of Postgraduate Periodontics, Maimónides University, Buenos Aires, Argentina.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Chambrone', 'Affiliation': 'School of Dentistry, Ibirapuera University, São Paulo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.20-0645']
1704,33140460,The acute and repeated effects of cigarette smoking and smoking-related cues on impulsivity.,"INTRODUCTION AND AIMS
Impulsivity may be a risk factor that increases vulnerability to nicotine dependence. However, nicotine exposure itself may directly increase impulsivity. This is a secondary analysis of the first study in a controlled laboratory setting, which assessed the effects of nicotine administration (acute and repeated) and exposure to smoking cues on behavioural impulsivity in humans (ClinicalTrials.gov Identifier: NCT01395797).
DESIGN AND METHODS
Twenty-seven smokers completed three tasks to assess behavioural impulsivity (the Immediate Memory Task and the Delayed Memory Task assessing response initiation, and the GoStop Task assessing response inhibition) following: (i) 4 days of cigarette smoking (nicotinised or denicotinised cigarette); (ii) acute cigarette smoking (nicotinised); and (iii) exposure to smoking-related cues.
RESULTS
Four days of nicotinised cigarette smoking (vs. denicotinised) did not significantly increase Immediate Memory Task, Delayed Memory Task and GoStop scores. However, acute cigarette smoking increased GoStop impulsivity, but only following 4 days of smoking nicotinised cigarettes (P < 0.05). Exposure to smoking-related cues had no statistically significant effect on impulsivity.
DISCUSSION AND CONCLUSIONS
Our results suggest that repeated nicotine exposure may sensitise subsequent acute nicotine effects on behavioural impulsivity in heavy smokers.",2020,"Four days of nicotinised cigarette smoking (vs. denicotinised) did not significantly increase Immediate Memory Task, Delayed Memory Task and GoStop scores.","['Twenty-seven smokers', 'heavy smokers']","['Immediate Memory Task and the Delayed Memory Task assessing response initiation, and the GoStop Task assessing response inhibition) following: (i) 4\u2009days of cigarette smoking (nicotinised or denicotinised cigarette); (ii) acute cigarette smoking (nicotinised); and (iii) exposure to smoking-related cues', 'cigarette smoking and smoking-related cues', 'nicotine administration (acute and repeated) and exposure to smoking cues']","['impulsivity', 'GoStop impulsivity', 'Immediate Memory Task, Delayed Memory Task and GoStop scores', 'behavioural impulsivity']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C3494625', 'cui_str': 'Heavy tobacco smoker'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0376364', 'cui_str': 'Delayed Memory'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0376364', 'cui_str': 'Delayed Memory'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",27.0,0.0130008,"Four days of nicotinised cigarette smoking (vs. denicotinised) did not significantly increase Immediate Memory Task, Delayed Memory Task and GoStop scores.","[{'ForeName': 'Suky', 'Initials': 'S', 'LastName': 'Martinez', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute, Columbia University Irving Medical Center, New York, USA.'}, {'ForeName': 'Jermaine D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute, Columbia University Irving Medical Center, New York, USA.'}, {'ForeName': 'Nehal P', 'Initials': 'NP', 'LastName': 'Vadhan', 'Affiliation': 'Departments of Psychiatry and Molecular Medicine, Zucker School of Medicine at Hofstra University/Northwell Health, Hempstead, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brandt', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute, Columbia University Irving Medical Center, New York, USA.'}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute, Columbia University Irving Medical Center, New York, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bisaga', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute, Columbia University Irving Medical Center, New York, USA.'}]",Drug and alcohol review,['10.1111/dar.13206']
1705,33140499,Effects of a group-based physical and cognitive intervention on social activity and quality of life for elderly people with dementia in a geriatric health service facility: a quasi-randomised controlled trial.,"BACKGROUND
The aim of this study was to assess the effects of group-based motor and cognitive-combined intervention on social activity and quality of life.
METHODS
This quasi-randomised controlled trial included 31 elderly participants with dementia in a geriatric health service facility. Participants were randomly allocated to the intervention group (n = 16) or the control group (n = 15) by stratification of cognitive function. The 8-week intervention program consisted of group exercise and cognitive stimulation twice per week for 45 min per session. Outcome measures were social activity in daily behaviour, cognitive function, apathy, muscle and grip strength, independence of activity of daily living, life-space, and objective quality of life (QOL).
RESULTS
Twenty-five participants were analysed (10 in the control group, 15 in the intervention group). Analysis of covariance with covariates of age, gender, and baseline data showed a significant difference in social activity (F = 8.67, P = 0.008; significant decline in control group vs. maintenance in intervention group) and QOL (F = 9.74, P = 0.006; maintenance in control group vs. tendency of improvement in intervention group). A Wilcoxon signed-rank test revealed that helping behaviour (P = 0.035) increased in the intervention group, whereas interest to the surrounding (P = 0.026) decreased in the control group.
CONCLUSIONS
Group-based combined intervention for dementia is effective for maintaining social activity and QOL in a geriatric health service facility.",2020,"A Wilcoxon signed-rank test revealed that helping behaviour (P = 0.035) increased in the intervention group, whereas interest to the surrounding (P = 0.026) decreased in the control group.
","['31 elderly participants with dementia in a geriatric health service facility', 'elderly people with dementia in a geriatric health service facility']","['group-based motor and cognitive-combined intervention', 'group exercise and cognitive stimulation', 'group-based physical and cognitive intervention']","['social activity in daily behaviour, cognitive function, apathy, muscle and grip strength, independence of activity of daily living, life-space, and objective quality of life (QOL', 'QOL', 'social activity', 'social activity and quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0018753', 'cui_str': 'Health Services for Aged'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",31.0,0.0540093,"A Wilcoxon signed-rank test revealed that helping behaviour (P = 0.035) increased in the intervention group, whereas interest to the surrounding (P = 0.026) decreased in the control group.
","[{'ForeName': 'Shigeya', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Takasaki University of Health and Welfare, Takasaki, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Yamagami', 'Affiliation': 'Gunma University Graduate School of Health Sciences, Maebashi, Japan.'}, {'ForeName': 'Haruyasu', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Gunma University Graduate School of Health Sciences, Maebashi, Japan.'}]",Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society,['10.1111/psyg.12627']
1706,33140515,A Randomized Phase II Study of Sequential Eribulin Versus Paclitaxel Followed by FAC/FEC as Neoadjuvant Therapy in Patients with Operable HER2-Negative Breast Cancer.,"LESSONS LEARNED
The combination of eribulin with FAC/FEC was not superior to the combination of paclitaxel with FAC/FEC and was associated with greater hematologic toxicity. Eribulin followed by an anthracycline-based regimen is not recommended as a standard neoadjuvant therapy in nonmetastatic operable breast cancer.
BACKGROUND
Neoadjuvant systemic therapy is the standard of care for locally advanced operable breast cancer. We hypothesized eribulin may improve the pathological complete response (pCR) rate compared with paclitaxel.
METHODS
We conducted a 1:1 randomized open-label phase II study comparing eribulin versus paclitaxel followed by 5-fluorouracil, either doxorubicin or epirubicin, and cyclophosphamide (FAC/FEC) in patients with operable HER2-negative breast cancer. pCR and toxicity of paclitaxel 80 mg/m 2 weekly for 12 doses or eribulin 1.4 mg/m 2 on days 1/8 of a 21-day cycle for 4 cycles followed by FAC/FEC were compared.
RESULTS
At the interim futility analysis, in March 2015, 51 patients (28 paclitaxel, 23 eribulin) had received at least 1 dose of the study drug and were thus evaluable for toxicity; of these, 47 (26 paclitaxel, 21 eribulin) had undergone surgery and were thus evaluable for efficacy. Seven of 26 (27%) in the paclitaxel group and 1 of 21 (5%) in the eribulin group achieved a pCR, and this result crossed a futility stopping boundary. In the paclitaxel group, the most common serious adverse events (SAEs) were neutropenic fever (grade 3, 3 patients, 11%). In the eribulin group, 9 patients (39%) had neutropenia-related SAEs, and 1 died of neutropenic sepsis. The study was thus discontinued. For the paclitaxel and eribulin groups, the 5-year event-free survival (EFS) rates were 81.8% and 74.0% (HR, 1.549; 95% CI, 0.817 to 2.938; p = .3767), and the 5-year OS rates were 100% and 84.4% (HR, 5.813; 95% CI, 0.647 to 52.208; p = .0752), respectively.
CONCLUSION
We did not observe a higher proportion of patients undergoing breast conservation surgery in the eribulin group than in the paclitaxel group. The patients treated with eribulin were more likely to undergo mastectomy and less likely to undergo breast conservation surgery, but the difference was not statistically significant. As neoadjuvant therapy for operable HER2-negative breast cancer, eribulin followed by FAC/FEC is not superior to paclitaxel followed by FAC/FEC and is associated with a higher incidence of neutropenia-related serious AEs.",2020,We did not observe a higher proportion of patients undergoing breast conservation surgery in the eribulin group than in the paclitaxel group.,"['nonmetastatic operable breast cancer', 'patients with operable HER2-negative breast cancer', 'Patients with Operable HER2-Negative Breast Cancer', 'locally advanced operable breast cancer']","['paclitaxel', 'anthracycline-based regimen', 'FAC/FEC', 'Sequential Eribulin Versus Paclitaxel Followed by FAC/FEC', 'eribulin versus paclitaxel followed by 5-fluorouracil, either doxorubicin or epirubicin, and cyclophosphamide (FAC/FEC', 'paclitaxel with FAC/FEC']","['neutropenic fever', 'pCR and toxicity', 'pathological complete response (pCR) rate', '5-year event-free survival (EFS) rates', 'neutropenia-related SAEs, and 1 died of neutropenic sepsis', 'toxicity', '5-year OS rates', 'hematologic toxicity']","[{'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0054427', 'cui_str': 'CAF protocol'}, {'cui': 'C0060133', 'cui_str': 'FEC protocol'}, {'cui': 'C2350866', 'cui_str': 'eribulin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877153', 'cui_str': 'Neutropenic sepsis'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}]",,0.0354512,We did not observe a higher proportion of patients undergoing breast conservation surgery in the eribulin group than in the paclitaxel group.,"[{'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Lim', 'Affiliation': 'Departments of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Juhee', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Departments of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Nuhad K', 'Initials': 'NK', 'LastName': 'Ibrahim', 'Affiliation': 'Departments of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Kimberly B', 'Initials': 'KB', 'LastName': 'Koenig', 'Affiliation': 'Departments of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Chavez-MacGregor', 'Affiliation': 'Departments of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Joe E', 'Initials': 'JE', 'LastName': 'Ensor', 'Affiliation': 'Departments of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jill Schwartz', 'Initials': 'JS', 'LastName': 'Gomez', 'Affiliation': 'Departments of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Savitri', 'Initials': 'S', 'LastName': 'Krishnamurthy', 'Affiliation': 'Departments of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Abigail S', 'Initials': 'AS', 'LastName': 'Caudle', 'Affiliation': 'Departments of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Simona F', 'Initials': 'SF', 'LastName': 'Shaitelman', 'Affiliation': 'Departments of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Whitman', 'Affiliation': 'Departments of Breast Imaging, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Valero', 'Affiliation': 'Departments of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}]",The oncologist,['10.1002/onco.13581']
1707,33140542,"Effect of liraglutide vs. placebo treatment on circulating proglucagon-derived peptides that mediate improvements in body weight, insulin secretion and action: a randomized controlled trial.","AIMS
To examine how circulating GLP-1 concentrations during liraglutide treatment relate to its therapeutic actions on glucose and weight, and to study the effects of liraglutide on other proglucagon-derived peptides (PGDPs), including endogenous GLP-1, GLP-2, glucagon, oxyntomodulin, glicentin, and major proglucagon fragment, which also regulate metabolic and weight control.
MATERIALS AND METHODS
Adults who were overweight/obese (BMI 27-40 kg/m 2 ) with prediabetes were randomized to liraglutide (1.8mg/day) vs placebo for 14 weeks. We used specific assays to measure exogenous (liraglutide, GLP-1 agonist (GLP-1A)) and endogenous (GLP-1E) GLP-1, alongside 5 other PGDP concentrations during a mixed-meal tolerance test (MMTT) completed at baseline and at week 14 (liraglutide, n=16; placebo, n=19). Glucose during MMTT, steady-state plasma glucose (SSPG) concentration for insulin resistance, and insulin secretion rate (ISR) were previously measured. MMTT area-under-the-curve (AUC) was calculated for ISR, glucose, and levels of PGDPs.
RESULTS
Participants on liraglutide vs placebo had significantly (p≤0.004) decreased weight (mean -3.6%, 95% CI [-5.2, -2.1]), SSPG (-32% [-43, -22]) and glucose AUC (-7.0% [-11.5, -2.5]), and increased ISR AUC (30%, [16, 44]). Treatment with liraglutide significantly (p≤0.005) increased exogenous GLP-1A AUC (median 310 vs 262 pg/mL X 8h at baseline but decreased endogenous GLP-1E AUC (13.1 vs 24.2 pmol/L x 8h at baseline)), as well as the 5 other PGDPs. Only glucagon AUC decreased in the placebo group (471 vs 594 pg/mL x 8h at baseline). GLP-1A AUC at study end was significantly (p≤0.04) linearly associated with % decrease in weight (r=-0.54) and SSPG (r=-0.59) and increase in ISR AUC (r=0.51) in the liraglutide group.
CONCLUSIONS
Circulating GLP-1A concentrations, reflecting liraglutide levels, predict improvement in weight, insulin action, and secretion in a linear manner. Importantly, liraglutide also downregulates all other PGDPs, normalization of the levels of which may provide additional metabolic benefits in the future. This article is protected by copyright. All rights reserved.",2020,Only glucagon AUC decreased in the placebo group (471 vs 594 pg/mL,['Adults who were overweight/obese (BMI 27-40 kg/m 2 ) with prediabetes'],"['liraglutide', 'liraglutide vs placebo', 'liraglutide vs. placebo', 'placebo', 'SSPG', 'exogenous (liraglutide, GLP-1 agonist (GLP-1A)) and endogenous (GLP-1E) GLP-1']","['endogenous GLP-1E AUC', 'weight (r=-0.54) and SSPG', 'weight', 'glucose AUC', 'ISR, glucose, and levels of PGDPs', 'glucagon AUC', 'ISR AUC', 'GLP-1A AUC', 'exogenous GLP-1A AUC', 'weight, insulin action, and secretion', 'Glucose during MMTT, steady-state plasma glucose (SSPG) concentration for insulin resistance, and insulin secretion rate (ISR', 'body weight, insulin secretion and action']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0061359', 'cui_str': 'glucagon-like peptide 1 (7-36)amide'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072092', 'cui_str': 'Proglucagon'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0061359', 'cui_str': 'glucagon-like peptide 1 (7-36)amide'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}]",,0.0995764,Only glucagon AUC decreased in the placebo group (471 vs 594 pg/mL,"[{'ForeName': 'Sun H', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology, Gerontology and Metabolism, Department of Medicine, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Abbasi', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Nachmanoff', 'Affiliation': 'Division of Endocrinology, Gerontology and Metabolism, Department of Medicine, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Stefanakis', 'Affiliation': 'Department of Medicine, Boston VA Healthcare system and Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Ansh Labs, 445 Medical Center Blvd, Webster, TX.'}, {'ForeName': 'Bhanu', 'Initials': 'B', 'LastName': 'Kalra', 'Affiliation': 'Ansh Labs, 445 Medical Center Blvd, Webster, TX.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Savjani', 'Affiliation': 'Ansh Labs, 445 Medical Center Blvd, Webster, TX.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Mantzoros', 'Affiliation': 'Department of Medicine, Boston VA Healthcare system and Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14242']
1708,33140566,Sitagliptin for the Prevention and Treatment of Perioperative Hyperglycaemia in Patients with Type 2 Diabetes Undergoing Cardiac Surgery: A Randomised Controlled Trial.,"BACKGROUND
Hyperglycaemia is associated with increased incidence of perioperative complications. We assessed whether treatment with sitagliptin, starting before surgery and continued during the hospital stay, can prevent and reduce the severity of perioperative hyperglycaemia in patients with type 2 diabetes undergoing coronary artery bypass graft (CABG) surgery.
MARTIALS AND METHODS
We conducted a double-blinded, placebo-control trial in adults with type 2 diabetes randomly assigned to receive sitagliptin or matching placebo starting one day prior to surgery and continued during the hospital stay. The primary outcome was difference in the proportion of patients with postoperative hyperglycaemia (blood glucose [BG] >10mmol/L [>180mg/dL]) in the intensive care unit (ICU). Secondary endpoints included differences in mean daily BG in the ICU and after transition to regular wards, hypoglycaemia, hospital complications, length of stay, and need of insulin therapy.
RESULTS
We included 182 participants randomised to receive sitagliptin or placebo (91 per group, age 64±9 years, HbA1C: 7∙6±1∙5%, and diabetes duration: 10±9 years). There were no differences in number of patients with postoperative BG >10 mmol/L, mean daily BG in the ICU or after transition to regular floors, hypoglycaemia, hospital complications or length of stay. There were no differences on insulin requirements in the ICU; however, sitagliptin therapy was associated with lower mean daily insulin requirements (21∙1±18∙4 vs 32∙5±26∙3 units, p=0∙007) after transition to regular floor compared to placebo.
CONCLUSION
The administration of sitagliptin prior to surgery and during the hospital stay, did not prevent perioperative hyperglycaemia or complications after CABG. Sitagliptin therapy was associated with lower mean daily insulin requirements after transition to regular floors. This article is protected by copyright. All rights reserved.",2020,"There were no differences in number of patients with postoperative BG >10 mmol/L, mean daily BG in the ICU or after transition to regular floors, hypoglycaemia, hospital complications or length of stay.","['Undergoing Cardiac Surgery', 'Patients with Type 2 Diabetes', 'adults with type 2 diabetes randomly assigned to receive', '182 participants randomised to receive', 'patients with type 2 diabetes undergoing coronary artery bypass graft (CABG) surgery']","['Sitagliptin therapy', 'sitagliptin or matching placebo', '10mmol/L', 'Sitagliptin', 'sitagliptin or placebo', 'placebo']","['mean daily insulin requirements', 'insulin requirements', 'hypoglycaemia, hospital complications or length of stay', 'proportion of patients with postoperative hyperglycaemia (blood glucose [BG] ', 'Perioperative Hyperglycaemia', 'perioperative hyperglycaemia or complications', 'mean daily BG in the ICU and after transition to regular wards, hypoglycaemia, hospital complications, length of stay, and need of insulin therapy']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",182.0,0.356821,"There were no differences in number of patients with postoperative BG >10 mmol/L, mean daily BG in the ICU or after transition to regular floors, hypoglycaemia, hospital complications or length of stay.","[{'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Tsegka', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Sol', 'Initials': 'S', 'LastName': 'Jacobs', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Halkos', 'Affiliation': 'Joseph B. Whitehead Department of Surgery, Emory University, Atlanta, Georgia, NCT.'}, {'ForeName': 'W Brent', 'Initials': 'WB', 'LastName': 'Keeling', 'Affiliation': 'Joseph B. Whitehead Department of Surgery, Emory University, Atlanta, Georgia, NCT.'}, {'ForeName': 'Georgia M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Albury', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Urrutia', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Rodolfo J', 'Initials': 'RJ', 'LastName': 'Galindo', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Migdal', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Macheers', 'Affiliation': 'Joseph B. Whitehead Department of Surgery, Emory University, Atlanta, Georgia, NCT.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Guyton', 'Affiliation': 'Joseph B. Whitehead Department of Surgery, Emory University, Atlanta, Georgia, NCT.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14241']
1709,33140673,Do High-Risk Parents Use More Aggression During Competitive Play With Children?,"The present study examined the extent to which the aggressive tendencies of parents at risk for perpetrating child physical abuse (CPA) generalize to situations other than discipline-related encounters (e.g., a competitive gaming interaction). Participants included parents who were either low ( n = 90) or high ( n = 75) risk for CPA. Parents were led to believe that they were playing a game against a child opponent with whom they exchanged sound blasts of varying intensities. Parental sound blast selections served as a proxy for aggressive behavior. Parents were randomly assigned to high or low loss conditions. The fictitious child opponent's responses were pre-programed so that sound blasts received by parents became louder (i.e., more provocative) over time. As predicted, high CPA risk parents exhibited higher levels of aggression than low CPA risk parents. Moreover, high-risk parents reported having higher levels of aggressive motives during the game than low-risk parents; and aggressive motives explained the link between parental CPA risk and parents' aggressive behavior. With one exception, higher levels of child provocation during the game prompted parents to send higher levels of sound blasts. The exception to this pattern occurred among low-risk parents who experienced high rates of loss during the game. Specifically, low-risk parents in the high loss condition continued to send low levels of sound blasts even as their child opponent became more provocative. Aggressive motives (and the ability to change motives as situations change) may help explain differences in aggressive tendencies evinced by parents with varying levels of CPA risk.",2020,"As predicted, high CPA risk parents exhibited higher levels of aggression than low CPA risk parents.",['Participants included parents who were either low ( n = 90) or high ( n = 75) risk for CPA'],[],"['aggressive motives', 'higher levels of child provocation']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0236861', 'cui_str': 'Physical child abuse'}]",[],"[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0449428', 'cui_str': 'Provocation'}]",,0.029024,"As predicted, high CPA risk parents exhibited higher levels of aggression than low CPA risk parents.","[{'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Crouch', 'Affiliation': 'Northern Illinois University, DeKalb, IL, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Skowronski', 'Affiliation': 'Northern Illinois University, DeKalb, IL, USA.'}, {'ForeName': 'America L', 'Initials': 'AL', 'LastName': 'Davila', 'Affiliation': 'Northern Illinois University, DeKalb, IL, USA.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Milner', 'Affiliation': 'Northern Illinois University, DeKalb, IL, USA.'}]",Journal of interpersonal violence,['10.1177/0886260520969246']
1710,33140994,Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder.,"Objectives: To evaluate the safety and efficacy of a digital therapeutic in treatment-seeking individuals with opioid use disorder (OUD) in an analysis of randomized clinical trial (RCT) data (ClinicalTrials.gov identifier: NCT00929253). Methods: Secondary analysis of an RCT including 170 adults meeting DSM-IV criteria for OUD. Participants were randomized to 12-weeks of treatment-as-usual (TAU) or TAU plus a digital therapeutic providing 67 digital, interactive educational modules based on the Community Reinforcement Approach. TAU consisted of buprenorphine maintenance therapy, 30 minutes biweekly clinician interaction, and abstinence-based contingency management. Primary endpoints were treatment retention and abstinence (negative urine drug screen) during weeks 9-12 of treatment. Safety was assessed by evaluating adverse events. Results: Participants randomized to TAU plus a digital therapeutic had significantly greater odds of opioid abstinence during weeks 9-12 compared to TAU: 77.3% versus 62.1% respectively (P = 0.02), OR 2.08, 95% CI 1.10-3.95. The risk of patients leaving treatment was significantly lower in the digital therapeutic group (HR 0.49, 95% CI 0.26-0.92). No significant difference was observed in the rate of adverse events between groups (P = 0.42). Conclusions: A prescription digital therapeutic in combination with buprenorphine therapy improves clinically significant patient outcomes including abstinence from illicit opioids and retention in treatment compared with treatment as usual.",2020,"The risk of patients leaving treatment was significantly lower in the digital therapeutic group (HR 0.49, 95% CI 0.26-0.92).","['170 adults meeting DSM-IV criteria for OUD', 'treatment-seeking individuals with opioid use disorder (OUD']","['TAU plus a digital therapeutic', 'buprenorphine therapy', 'prescription digital therapeutic', 'buprenorphine', 'buprenorphine maintenance therapy', 'treatment-as-usual (TAU) or TAU plus a digital therapeutic providing 67 digital, interactive educational modules based on the Community Reinforcement Approach', 'digital therapeutic']","['Safety', 'Safety and efficacy', 'safety and efficacy', 'opioid abstinence', 'abstinence from illicit opioids and retention', 'treatment retention and abstinence (negative urine drug screen', 'risk of patients leaving treatment', 'rate of adverse events']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",170.0,0.183941,"The risk of patients leaving treatment was significantly lower in the digital therapeutic group (HR 0.49, 95% CI 0.26-0.92).","[{'ForeName': 'Yuri A', 'Initials': 'YA', 'LastName': 'Maricich', 'Affiliation': 'Pear Therapeutics, Inc., Boston, MA, USA.'}, {'ForeName': 'Warren K', 'Initials': 'WK', 'LastName': 'Bickel', 'Affiliation': 'Fralin Biomedical Research Institute at VTC, Roanoke, VA, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Marsch', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Gatchalian', 'Affiliation': 'Fralin Biomedical Research Institute at VTC, Roanoke, VA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Botbyl', 'Affiliation': 'Provonix, Sewell, NJ, USA.'}, {'ForeName': 'Hilary F', 'Initials': 'HF', 'LastName': 'Luderer', 'Affiliation': 'Pear Therapeutics, Inc., Boston, MA, USA.'}]",Current medical research and opinion,['10.1080/03007995.2020.1846022']
1711,33141065,Airflow dynamics and exhaled-breath temperature following cold-water ingestion.,"INTRODUCTION
Drinking cold water evokes decreases in spirometric indices of lung function. We studied whether this could be explained by changes in exhaled-breath temperature (EBT), airflow dynamics, and spirometer measurement sensitivity.
METHODS
In a randomized/crossover design, 10 healthy adults consumed 1000 mL refrigerated water (2.1 ± 0.64 °C) or water at room temperature (19.4 ± 0.5 °C), with EBT assessed at baseline and at 5, 10, 15 and 30-min post-ingestion. The influence of EBT on pneumotachograph measurement characteristics was modelled using computational fluid dynamics (CFD).
RESULTS
At 5-min post-ingestion, EBT was lower (p < 0.001) following the ingestion of cold water versus water at room-temperature (31.7 ± 1.1 vs. 33.0 ± 0.9 °C), and remained lower until 30-min post-ingestion. At a flow of 8 L s -1 , a decrease in EBT of 2.1 °C (as observed following cold-water ingestion) was modelled to underpredict lung volume by 0.7%.
CONCLUSIONS
Cold water reduces EBT below baseline but effects pneumotachograph measurements only negligibly. Therefore, decreased lung function following cold-water ingestion likely has a physiological explanation which warrants further study.",2020,"At 5-min post-ingestion, EBT was lower (p < 0.001) following the ingestion of cold water versus water at room-temperature (31.7 ± 1.1 vs. 33.0 ± 0.9 °C), and remained lower until 30-min post-ingestion.","['10 healthy adults consumed 1000 mL refrigerated water (2.1 ± 0.64 °C) or water at room temperature (19.4 ± 0.5 °C), with EBT assessed at baseline and at 5, 10, 15 and 30-min post-ingestion']",['EBT'],"['exhaled-breath temperature (EBT), airflow dynamics, and spirometer measurement sensitivity', 'EBT', 'spirometric indices of lung function', 'lung function', 'Airflow dynamics and exhaled-breath temperature']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C4517470', 'cui_str': '0.64'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C4709305', 'cui_str': '19.4'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0225387', 'cui_str': 'Exhaled air'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0225387', 'cui_str': 'Exhaled air'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0183441', 'cui_str': 'Spirometer'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",10.0,0.0478814,"At 5-min post-ingestion, EBT was lower (p < 0.001) following the ingestion of cold water versus water at room-temperature (31.7 ± 1.1 vs. 33.0 ± 0.9 °C), and remained lower until 30-min post-ingestion.","[{'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Tiller', 'Affiliation': 'Institute of Respiratory Medicine and Exercise Physiology, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, United States. Electronic address: nicholas.tiller@lundquist.org.'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Turner', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Gloucester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hart', 'Affiliation': 'Centre for Sports Engineering Research, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': 'Institute of Respiratory Medicine and Exercise Physiology, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, United States.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103564']
1712,33141078,"Aquatic exercise improves functional capacity, perceptual aspects, and quality of life in older adults with musculoskeletal disorders and risk of falling: A randomized controlled trial.","BACKGROUND
This study aimed to determine the effects of an aquatic training program on functional capacity, perceptual aspects, and quality of life (QoL) performed by older adults with musculoskeletal disorders (MSDs) and moderate/high risk of falls.
METHODS
This randomized controlled trial included 120 older adults assigned to aquatic exercises (AG; n = 60; 70.62 ± 6.04 years) and a control group (CG; n = 60; 71.86 ± 6.95 years). The risk of falls, perceptual aspects (fall risk awareness and pain), functional capacity (lower and upper body strength, lower and upper body flexibility, functional mobility, and balance) and QoL were assessed at baseline and after the experimental protocol. The AG performed 16 weeks of aquatic exercises (twice per week, 45 min.session -1 ) with lower and upper body strength, stretching, and balance exercises. Exercise intensity was controlled using the rate of perceived exertion (12-16 on the Borg scale [6-20 points]) and heart rate (progressing from 40% to 60% of the heart-rate reserve).
RESULTS
The training program improved the lower (mean difference [95% CI]: 2.7 [2.0 to 3.3]) and upper body strength (3.5 [2.6 to 4.5]), lower (4.6 [3.4 to 5.8]) and upper body flexibility (6.5 [4.3 to 8.6]), functional mobility (-2.5 [-2.9 to -1.9]), and balance (11.2 [10.6 to 11.9]); reduced pain perception (-3.2 [-3.7 to -2.8]); increased the fall risk awareness (9.5 [8.8 to 10.1]) and QoL perception (5.6 to 22.6 [4.6 to 25.1]).
CONCLUSIONS
The water-based program may be used as a preventive approach for the older adults with MSDs and at risk of falling to improve physical and usual perceptual aspects (QoL and pain) and fall risk awareness.",2020,"The training program improved the lower (mean difference [95% CI]: 2.7 [2.0 to 3.3]) and upper body strength (3.5 [2.6 to 4.5]), lower (4.6 [3.4 to 5.8]) and upper body flexibility (6.5 [4.3 to 8.6]), functional mobility (-2.5 [-2.9 to -1.9]), and balance (11.2 [10.6 to 11.9]); reduced pain perception (-3.2 [-3.7 to -2.8]); increased the fall risk awareness (9.5 [8.8 to 10.1]) and QoL perception (5.6 to 22.6 [4.6 to 25.1]).
","['120 older adults assigned to', 'older adults with musculoskeletal disorders (MSDs) and moderate/high risk of falls', 'older adults with musculoskeletal disorders and risk of falling', 'older adults with MSDs']","['aquatic training program', 'aquatic exercises', 'Aquatic exercise']","['risk of falls, perceptual aspects (fall risk awareness and pain), functional capacity (lower and upper body strength, lower and upper body flexibility, functional mobility, and balance) and QoL', 'Exercise intensity', 'fall risk awareness', 'functional capacity, perceptual aspects, and quality of life (QoL', 'functional capacity, perceptual aspects, and quality of life', 'pain perception', 'heart rate', 'QoL perception', 'upper body flexibility', 'functional mobility', 'upper body strength', 'rate of perceived exertion']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",120.0,0.0368855,"The training program improved the lower (mean difference [95% CI]: 2.7 [2.0 to 3.3]) and upper body strength (3.5 [2.6 to 4.5]), lower (4.6 [3.4 to 5.8]) and upper body flexibility (6.5 [4.3 to 8.6]), functional mobility (-2.5 [-2.9 to -1.9]), and balance (11.2 [10.6 to 11.9]); reduced pain perception (-3.2 [-3.7 to -2.8]); increased the fall risk awareness (9.5 [8.8 to 10.1]) and QoL perception (5.6 to 22.6 [4.6 to 25.1]).
","[{'ForeName': 'Natália Boneti', 'Initials': 'NB', 'LastName': 'Moreira', 'Affiliation': 'Department of Physiotherapy, Federal University of Paraná, Setor de Ciências Biológicas, Curitiba, Paraná, Brazil. Electronic address: nataliamoreira@ufpr.br.'}, {'ForeName': 'Letícia Pophal', 'Initials': 'LP', 'LastName': 'da Silva', 'Affiliation': 'Department of Physical Education, Federal University of Paraná, Setor de Ciências Biológicas, Curitiba, Paraná, Brazil. Electronic address: leticiapophal@ufpr.br.'}, {'ForeName': 'André Luiz Felix', 'Initials': 'ALF', 'LastName': 'Rodacki', 'Affiliation': 'Department of Physical Education, Federal University of Paraná, Setor de Ciências Biológicas, Curitiba, Paraná, Brazil. Electronic address: rodacki@ufpr.br.'}]",Experimental gerontology,['10.1016/j.exger.2020.111135']
1713,33141092,A Mobile-Based Intervention for Dietary Behavior and Physical Activity Change in Individuals at High Risk for Type 2 Diabetes Mellitus: Randomized Controlled Trial.,"BACKGROUND
Intensive lifestyle modifications have proved effective in preventing type 2 diabetes mellitus (T2DM), yet the efficiency and effectiveness of these modifications need to be improved. Emerging social media interventions are considered useful in promoting these lifestyles; nevertheless, few studies have investigated the effectiveness of combining them with behavior theory.
OBJECTIVE
This study aims to examine the effectiveness of a 6-month mobile-based intervention (DHealthBar, a WeChat applet) combined with behavioral theory compared with a printed intervention in improving dietary behaviors, physical activity, and intention to change these behaviors among populations at high risk for T2DM.
METHODS
Participants aged 23 to 67 years were recruited offline in Beijing, China, and were randomized into the intervention group or the control group, which received educational content via DHealthBar or a printed handbook, respectively. Educational materials were culturally tailored recommendations on improving dietary behaviors, physical activity, and intention to change based on the transtheoretical model. Participants in the intervention arm received push notifications twice per week on WeChat and had access to the educational content for the 6-month study period. Participants in the control arm received the same intervention content through printed materials. The outcomes of participants' behavior change, intention to change behavior, and anthropometric characteristics were collected via online measuring tools at baseline, 3 months, and 6 months.
RESULTS
In this study, 79 enrolled individuals completed baseline information collection (control: n=38 vs intervention: n=41), and 96% (76/79) completed the 6-month follow-up visit. Attrition rates did not differ significantly between the 2 groups (χ 2 1 =0.0, P=.61). Baseline equivalence was found. Participants in both groups reported a statistically significant decrease in energy intake at the 2 follow-up assessments compared with baseline (3 months, control: exp[β]=0.83, 95% CI 0.74-0.92 vs intervention: exp[β]=0.76, 95% CI 0.68-0.85; 6 months, control: exp[β]=0.87, 95% CI 0.78-0.96 vs intervention: exp[β]=0.57, 95% CI 0.51-0.64). At 6 months, a significantly larger decrease was observed in the intervention group in energy, fat, and carbohydrate intake, accompanied with a significantly larger increase in moderate-intensity physical activity compared with the control group (energy: exp[β]=0.66, 95% CI 0.56-0.77; fat: exp[β]=0.71, 95% CI 0.54-0.95; carbohydrates: exp[β]=0.83, 95% CI 0.66-1.03; moderate-intensity physical activity: exp[β]=2.05, 95% CI 1.23-3.44). After 6 months of the intervention, participants in the intervention group were more likely to be at higher stages of dietary behaviors (exp[β]=26.80, 95% CI 3.51-204.91) and physical activity (exp[β]=15.60, 95% CI 2.67-91.04) than the control group.
CONCLUSIONS
DHealthBar was initially effective in improving dietary behavior, physical activity, and intention to change these behaviors among populations who were at high risk of developing T2DM, with significant differences in the changes of outcomes over the 6-month intervention period.
TRIAL REGISTRATION
Chinese Clinical Trial Registry ChiCTR2000032323; https://tinyurl.com/y4h8q4uf.",2020,"Attrition rates did not differ significantly between the 2 groups (χ 2 1 =0.0, P=.61).","['populations at high risk for T2DM', 'Individuals at High Risk for Type 2 Diabetes Mellitus', '79 enrolled individuals completed baseline information collection (control: n=38 vs intervention: n=41), and 96% (76/79) completed the 6-month follow-up visit', 'Participants aged 23 to 67 years were recruited offline in Beijing, China']","['educational content via DHealthBar or a printed handbook, respectively', '6-month mobile-based intervention (DHealthBar, a WeChat applet) combined with behavioral theory compared with a printed intervention', 'push notifications twice per week on WeChat', 'Mobile-Based Intervention for Dietary Behavior and Physical Activity Change']","['dietary behavior, physical activity, and intention', ""participants' behavior change, intention to change behavior, and anthropometric characteristics"", 'dietary behaviors, physical activity, and intention to change based on the transtheoretical model', 'physical activity', 'moderate-intensity physical activity', 'energy intake', 'dietary behaviors', 'Attrition rates', 'energy, fat, and carbohydrate intake']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0596654', 'cui_str': 'Handbooks'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",79.0,0.149961,"Attrition rates did not differ significantly between the 2 groups (χ 2 1 =0.0, P=.61).","[{'ForeName': 'Zidu', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Institute of Medical Information and Library, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Geng', 'Affiliation': 'School of Nursing, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Nursing Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Institute of Medical Information and Library, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Institute of Medical Information and Library, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",JMIR mHealth and uHealth,['10.2196/19869']
1714,33141094,Impact of Remote Titration Combined With Telemonitoring on the Optimization of Guideline-Directed Medical Therapy for Patients With Heart Failure: Internal Pilot of a Randomized Controlled Trial.,"BACKGROUND
To improve health outcomes in patients with heart failure, guideline-directed medical therapy (GDMT) should be optimized to target doses. However, GDMT remains underutilized, with less than 25% of patients receiving target doses in clinical practice. Telemonitoring could provide reliable and real-time physiological data for clinical decision support to facilitate remote GDMT titration.
OBJECTIVE
This paper aims to present findings from an internal pilot study regarding the effectiveness of remote titration facilitated by telemonitoring.
METHODS
A 2-arm randomized controlled pilot trial comparing remote titration versus standard care in a heart function clinic was conducted. Patients were randomized to undergo remote medication titration facilitated by data from a smartphone-based telemonitoring system or standard titration performed during clinic visits.
RESULTS
A total of 42 patients with new-onset (10/42, 24%) and existing (32/42, 76%) heart failure and a mean age of 55.29 (SD 11.28) years were randomized between January and June 2019. Within 6 months of enrollment, 86% (18/21) of patients in the intervention group achieved optimal doses versus 48% (10/21) of patients in the control group. The median time to dose optimization was 11.0 weeks for the intervention group versus 18.8 weeks for the control group. The number of in-person visits in the intervention group was 54.5% lower than in the control group.
CONCLUSIONS
The results of this pilot study suggest that remote titration facilitated by telemonitoring has the potential to increase the proportion of patients who achieve optimal GDMT doses, decrease time to dose optimization, and reduce the number of clinic visits. Remote titration may facilitate optimal and efficient titration of patients with heart failure while reducing the burden for patients to attend in-person clinic visits.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04205513; https://clinicaltrials.gov/ct2/show/NCT04205513.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.2196/preprints.19705.",2020,The median time to dose optimization was 11.0 weeks for the intervention group versus 18.8 weeks for the control group.,"['Patients With Heart Failure', 'patients with heart failure, guideline-directed medical therapy (GDMT', 'patients with heart failure', '42 patients with new-onset (10/42, 24%) and existing (32/42, 76%) heart failure and a mean age of 55.29 (SD 11.28) years were randomized between January and June 2019']","['remote titration versus standard care', 'smartphone-based telemonitoring system or standard titration performed during clinic visits', 'Remote Titration Combined With Telemonitoring']","['median time to dose optimization', 'number of in-person visits', 'number of clinic visits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]",42.0,0.0994951,The median time to dose optimization was 11.0 weeks for the intervention group versus 18.8 weeks for the control group.,"[{'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Artanian', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ross', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Valeria E', 'Initials': 'VE', 'LastName': 'Rac', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""O'Sullivan"", 'Affiliation': 'Peter Munk Cardiac Centre, Division of Cardiology, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Darshan H', 'Initials': 'DH', 'LastName': 'Brahmbhatt', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Seto', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}]",JMIR cardio,['10.2196/21962']
1715,33141096,Computer-Tailored Decision Support Tool for Lung Cancer Screening: Community-Based Pilot Randomized Controlled Trial.,"BACKGROUND
Lung cancer screening is a US Preventive Services Task Force Grade B recommendation that has been shown to decrease lung cancer-related mortality by approximately 20%. However, making the decision to screen, or not, for lung cancer is a complex decision because there are potential risks (eg, false positive results, overdiagnosis). Shared decision making was incorporated into the lung cancer screening guideline and, for the first time, is a requirement for reimbursement of a cancer screening test from Medicare. Awareness of lung cancer screening remains low in both the general and screening-eligible populations. When a screening-eligible person visits their clinician never having heard about lung cancer screening, engaging in shared decision making to arrive at an informed decision can be a challenge. Methods to effectively prepare patients for these clinical encounters and support both patients and clinicians to engage in these important discussions are needed.
OBJECTIVE
The aim of the study was to estimate the effects of a computer-tailored decision support tool that meets the certification criteria of the International Patient Decision Aid Standards that will prepare individuals and support shared decision making in lung cancer screening decisions.
METHODS
A pilot randomized controlled trial with a community-based sample of 60 screening-eligible participants who have never been screened for lung cancer was conducted. Approximately half of the participants (n=31) were randomized to view LungTalk-a web-based tailored computer program-while the other half (n=29) viewed generic information about lung cancer screening from the American Cancer Society. The outcomes that were compared included lung cancer and screening knowledge, lung cancer screening health beliefs (perceived risk, perceived benefits, perceived barriers, and self-efficacy), and perception of being prepared to engage in a discussion about lung cancer screening with their clinician.
RESULTS
Knowledge scores increased significantly for both groups with greater improvement noted in the group receiving LungTalk (2.33 vs 1.14 mean change). Perceived self-efficacy and perceived benefits improved in the theoretically expected directions.
CONCLUSIONS
LungTalk goes beyond other decision tools by addressing lung health broadly, in the context of performing a low-dose computed tomography of the chest that has the potential to uncover other conditions of concern beyond lung cancer, to more comprehensively educate the individual, and extends the work of nontailored decision aids in the field by introducing tailoring algorithms and message framing based upon smoking status in order to determine what components of the intervention drive behavior change when an individual is informed and makes the decision whether to be screened or not to be screened for lung cancer.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.2196/resprot.8694.",2020,"RESULTS
Knowledge scores increased significantly for both groups with greater improvement noted in the group receiving LungTalk (2.33 vs 1.14 mean change).","['community-based sample of 60 screening-eligible participants who have never been screened for lung cancer was conducted', 'Lung Cancer Screening']","['view LungTalk-a web-based tailored computer program-while the other half (n=29) viewed generic information about lung cancer screening from the American Cancer Society', 'Computer-Tailored Decision Support Tool']","['Perceived self-efficacy', 'Knowledge scores', 'lung cancer and screening knowledge, lung cancer screening health beliefs (perceived risk, perceived benefits, perceived barriers, and self-efficacy), and perception of being prepared to engage in a discussion about lung cancer screening with their clinician']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]",60.0,0.0523865,"RESULTS
Knowledge scores increased significantly for both groups with greater improvement noted in the group receiving LungTalk (2.33 vs 1.14 mean change).","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Carter-Harris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Robert Skipworth', 'Initials': 'RS', 'LastName': 'Comer', 'Affiliation': 'Indiana University School of Informatics and Computing, Indianapolis, IN, United States.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Slaven Ii', 'Affiliation': 'School of Medicine, Indiana University, Indianapolis, IN, United States.'}, {'ForeName': 'Patrick O', 'Initials': 'PO', 'LastName': 'Monahan', 'Affiliation': 'School of Medicine, Indiana University, Indianapolis, IN, United States.'}, {'ForeName': 'Emilee', 'Initials': 'E', 'LastName': 'Vode', 'Affiliation': 'Indiana University School of Nursing, Indianapolis, IN, United States.'}, {'ForeName': 'Nasser H', 'Initials': 'NH', 'LastName': 'Hanna', 'Affiliation': 'School of Medicine, Indiana University, Indianapolis, IN, United States.'}, {'ForeName': 'DuyKhanh Pham', 'Initials': 'DP', 'LastName': 'Ceppa', 'Affiliation': 'School of Medicine, Indiana University, Indianapolis, IN, United States.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Rawl', 'Affiliation': 'Indiana University School of Nursing, Indianapolis, IN, United States.'}]",Journal of medical Internet research,['10.2196/17050']
1716,33141099,Effect of a Text Messaging-Based Educational Intervention on Cesarean Section Rates Among Pregnant Women in China: Quasirandomized Controlled Trial.,"BACKGROUND
Consensus exists that appropriate regional cesarean rates should not exceed 15% of births, but China's cesarean rate exceeds 50% in some areas, prompting numerous calls for its reduction. At present, China's 2016 two-child policy has heightened the implications of national cesarean section trends.
OBJECTIVE
This study leveraged pervasive cellular phone access amongst Chinese citizens to test the effect of a low-cost and scalable prenatal advice program on cesarean section rates.
METHODS
Participants were pregnant women presenting for antenatal care at a clinic in Xi'an, China. Assignment was quasirandomized and utilized factorial assignment based on the expecting mother's birthday. Participants were assigned to one of the following four groups, with each receiving a different set of messages: (1) a comparison group that received only a few ""basic"" messages, (2) a group receiving messages primarily regarding care seeking, (3) a group receiving messages primarily regarding good home prenatal practices, and (4) a group receiving text messages of all groups. Messages were delivered throughout pregnancy and were tailored to each woman's gestational week. The main outcome was the rates of cesarean delivery reported in the intervention arms. Data analysts were blinded to treatment assignment.
RESULTS
In total, 2115 women completed the trial and corresponding follow-up surveys. In the unadjusted analysis, the group receiving all texts was associated with an odds ratio of 0.77 (P=.06), though neither the care seeking nor good home prenatal practice set yielded a relevant impact. Adjusting for potentially confounding covariates showed that the group with all texts sent together was associated with an odds ratio of 0.67 (P=.01). Notably, previous cesarean section evoked an odds ratio of 11.78 (P<.001), highlighting that having a cesarean section predicts future cesarean section in a subsequent pregnancy.
CONCLUSIONS
Sending pregnant women in rural China short informational messages with integrated advice regarding both care-seeking and good home prenatal practices appears to reduce women's likelihood of undergoing cesarean section. Reducing clear medical indications for cesarean section seems to be the strongest potential pathway of the effect. Cesarean section based on only maternal request did not seem to occur regularly in our study population. Preventing unnecessary cesarean section at present may have a long-term impact on future cesarean section rates.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02037087; https://clinicaltrials.gov/ct2/show/NCT02037087.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.1136/bmjopen-2015-011016.",2020,"In the unadjusted analysis, the group receiving all texts was associated with an odds ratio of 0.77 (P=.06), though neither the care seeking nor good home prenatal practice set yielded a relevant impact.","['Pregnant Women in China', ""Participants were pregnant women presenting for antenatal care at a clinic in Xi'an, China"", '2115 women completed the trial and corresponding follow-up surveys', 'Sending pregnant women in rural']","['Text Messaging-Based Educational Intervention', 'low-cost and scalable prenatal advice program', 'China short informational messages with integrated advice regarding both care-seeking and good home prenatal practices', 'comparison group that received only a few ""basic"" messages, (2) a group receiving messages primarily regarding care seeking, (3) a group receiving messages primarily regarding good home prenatal practices, and (4) a group receiving text messages of all groups']","['rates of cesarean delivery', 'Cesarean Section Rates', 'cesarean section rates']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",2115.0,0.0904687,"In the unadjusted analysis, the group receiving all texts was associated with an odds ratio of 0.77 (P=.06), though neither the care seeking nor good home prenatal practice set yielded a relevant impact.","[{'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'School of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Heitner', 'Affiliation': 'Aceso Global, Washington, DC, United States.'}, {'ForeName': 'Changzheng', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': ""The Children's Hospital and School of Public Health, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Si', 'Affiliation': 'School of Risk & Actuarial Studies and Centre of Excellence in Population Ageing Research (CEPAR), University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""School of Public Policy and Administration, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, China.""}, {'ForeName': 'Zhongliang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""School of Public Policy and Administration, Xi'an Jiaotong University, Xi'an, China.""}]",JMIR mHealth and uHealth,['10.2196/19953']
1717,33141228,Short-term Efficacy of the Percutaneous Vertebroplasty Using a Curved Versus Straight Vertebroplasty Needle in Osteoporotic Vertebral Compression Fractures.,"The purpose of this study was to compare the efficacy of the curved puncture approach with 2 conventional approaches in percutaneous vertebroplasty (PVP) for the treatment of single-level osteoporotic vertebral compression fractures. Ninety-six patients with a single-level thoracolumbar vertebral fracture were surgically treated in the authors' department from February 2016 to February 2018. Patients were randomly divided into 3 groups, including 25 patients who had PVP punctured with a curved vertebroplasty needle (group C), 40 patients with unipedicular PVP with a straight vertebroplasty needle (group U), and 31 patients with bipedicular PVP with a straight vertebroplasty needle (group B). The short-term efficacies of PVP using different vertebroplasty needles were compared. Significant differences were tested preoperatively and postoperatively in vertebral body height variation, visual analog scale score, and Oswestry Disability Index in each of the 3 groups (P<.05). There was no significant difference among the groups in terms of Cobb angle correction and bone cement leakage. Group C and group U were superior to group B in terms of operative time and injected cement volume (P<.05). Twenty-four (96.0%) patients in group C and 29 (93.5%) patients in group B had centered cement distribution without significant differences (P>.05), which was superior to group U (P<.05). Curved puncture PVP achieved a satisfactory clinical outcome for osteoporotic vertebral compression fractures, with the advantages of less operative time, less injected cement volume, and more reasonable cement distribution for stabilization of the affected vertebrae. [Orthopedics. 2021;44(x):xx-xx.].",2020,Group C and group U were superior to group B in terms of operative time and injected cement volume (P<.05).,"['40 patients with', 'Osteoporotic Vertebral Compression Fractures', 'single-level osteoporotic vertebral compression fractures', '25 patients who had PVP punctured with a', 'group U), and 31 patients with', ""Ninety-six patients with a single-level thoracolumbar vertebral fracture were surgically treated in the authors' department from February 2016 to February 2018""]","['curved vertebroplasty needle', 'curved puncture approach with 2 conventional approaches in percutaneous vertebroplasty (PVP', 'Curved puncture PVP', 'bipedicular PVP with a straight vertebroplasty needle', 'unipedicular PVP with a straight vertebroplasty needle', 'PVP', 'Percutaneous Vertebroplasty Using a Curved Versus Straight Vertebroplasty Needle']","['vertebral body height variation, visual analog scale score, and Oswestry Disability Index', 'Cobb angle correction and bone cement leakage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0441854', 'cui_str': 'Group U'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C3812881', 'cui_str': 'Author'}]","[{'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}]","[{'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0005934', 'cui_str': 'Bone cements'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",96.0,0.0134933,Group C and group U were superior to group B in terms of operative time and injected cement volume (P<.05).,"[{'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Geng', 'Affiliation': ''}, {'ForeName': 'Quanfa', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Guowei', 'Initials': 'G', 'LastName': 'Shang', 'Affiliation': ''}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': ''}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Kou', 'Affiliation': ''}, {'ForeName': 'Hongjian', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ''}]",Orthopedics,['10.3928/01477447-20201012-03']
1718,33141262,Multidimensional breathlessness assessment during cardiopulmonary exercise testing in healthy adults.,"PURPOSE
This study explored if healthy adults could discriminate between different breathlessness dimensions when rated immediately one after another (successively) during symptom-limited incremental cardiopulmonary cycle exercise testing (CPET) using multiple single-item rating scales.
METHODS
Fifteen apparently healthy adults (60% male) aged 22 ± 2 years performed six incremental cycle CPETs separated by ≥ 48 h. During each CPET (at rest, every 2-min and at end exercise), participants rated different breathlessness sensations using the 0-10 modified Borg scale using one of six assessment protocols, randomized for order: (1) 'BREATHLESS ALL ' = breathlessness sensory intensity (SI), breathlessness unpleasantness (UN), work/effort of breathing (SQ W/E ), and unsatisfied inspiration (SQ UI ) assessed; (2) SI and UN assessed; and (3-6) SI, UN, SQ W/E , and SQ UI each assessed alone. Physiological responses to CPET were also evaluated.
RESULTS
Physiological and breathlessness responses to CPET were comparable across the six protocols, with the exception of SI rated lower at the highest submaximal power output (220 ± 56 watts) during the BREATHLESS ALL protocol (0-10 Borg units 4.2 ± 1.7) compared to SI + UN (5.2 ± 2.1, p = 0.03) and SI alone (5.1 ± 1.9, p = 0.04) protocols. Ratings of SI and SQ W/E were not significantly different when assessed in the same protocol, and were significantly higher than UN and SQ UI , which were comparable.
CONCLUSION
In healthy younger adults, use of two separate single-item rating scales to assess breathlessness during CPET is feasible and enables the distinct sensory intensity and affective dimensions of exertional breathlessness to be assessed.",2020,"In healthy younger adults, use of two separate single-item rating scales to assess breathlessness during CPET is feasible and enables the distinct sensory intensity and affective dimensions of exertional breathlessness to be assessed.","['healthy adults', 'Fifteen apparently healthy adults (60% male) aged 22\u2009±\u20092\xa0years performed six incremental cycle CPETs separated by\u2009≥\u200948\xa0h', 'healthy younger adults']",[],"['Multidimensional breathlessness assessment', 'breathlessness sensory intensity (SI), breathlessness unpleasantness (UN), work/effort of breathing (SQ W/E ), and unsatisfied inspiration (SQ UI ) assessed; (2) SI and UN assessed; and (3-6) SI, UN, SQ W/E , and SQ UI each assessed alone', 'Ratings of SI and SQ W/E']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0055954', 'cui_str': 'Clostridium perfringens epsilon toxin'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0442759', 'cui_str': '3/6'}]",15.0,0.0565055,"In healthy younger adults, use of two separate single-item rating scales to assess breathlessness during CPET is feasible and enables the distinct sensory intensity and affective dimensions of exertional breathlessness to be assessed.","[{'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Lewthwaite', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, 475 Pine Avenue West, Montréal, QC, H2W 1S4, Canada. Hayley.Lewthwaite@mcgill.ca.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Jensen', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, 475 Pine Avenue West, Montréal, QC, H2W 1S4, Canada.'}]",European journal of applied physiology,['10.1007/s00421-020-04537-9']
1719,33141277,Quality of life and patient satisfaction after single- and multiport laparoscopic surgery in colon cancer: a multicentre randomised controlled trial (SIMPLE Trial).,"BACKGROUND
The clinical benefits of single-port laparoscopic surgery (SPLS) in patients with colon cancer patients are unclear because only a few studies have reported on the quality of life (QoL) of such patients. This study aimed to compare the QoL and patient satisfaction between SPLS and multiport laparoscopic surgery (MPLS) in colon cancer.
METHODS
The multicentre randomised controlled SIngle-port versus MultiPort Laparoscopic surgEry (SIMPLE) trial included patients with colon cancer who underwent radical surgery at seven hospitals in South Korea. We performed a pre-planned secondary analysis of the QoL data of 359 patients from that trial. The QoL was surveyed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 preoperatively and at 1, 3, 6, and 12 months postoperatively. Patient satisfaction was measured with a 5-point questionnaire at these postoperative time points.
RESULTS
Overall, 145 and 147 patients were included in the SPLS and MPLS groups, respectively. Most QoL domains were similar between the groups. In the subgroup analysis of patients without adjuvant chemotherapy, patients in the SPLS group presented with significantly better global health status (p = 0.017), fatigue (p = 0.047), and pain (p = 0.005) scores and tended to have improved physical (p = 0.055), emotional (p = 0.064), and social (p = 0.081) functioning, with marginal significance at 1 month postoperatively, compared to those in the MPLS group. Patient satisfaction regarding surgery (p = 0.002) and appearance of the abdominal scar (p = 0.002) was significantly higher with SPLS than with MPLS at 12 months postoperatively.
CONCLUSION
Patients who underwent SPLS without adjuvant chemotherapy had better global health status, fatigue status, and pain at 1 month postoperatively; however, these improvements were minimal and temporary. In the near future, the effect of SPLS on postoperative QoL should be confirmed through a randomised controlled trial targeting the QoL in colon cancer patients.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01480128.",2020,"In the subgroup analysis of patients without adjuvant chemotherapy, patients in the SPLS group presented with significantly better global health status (p = 0.017), fatigue (p = 0.047), and pain (p = 0.005) scores and tended to have improved physical (p = 0.055), emotional (p = 0.064), and social (p = 0.081) functioning, with marginal significance at 1 month postoperatively, compared to those in the MPLS group.","['patients with colon cancer who underwent radical surgery at seven hospitals in South Korea', '145 and 147 patients were included in the SPLS and MPLS groups, respectively', '359 patients from that trial', 'colon cancer patients', 'colon cancer', 'patients with colon cancer patients']","['MultiPort Laparoscopic surgEry (SIMPLE', 'SPLS and multiport laparoscopic surgery (MPLS', 'single- and multiport laparoscopic surgery', 'single-port laparoscopic surgery (SPLS', 'SPLS without adjuvant chemotherapy', 'SPLS']","['global health status, fatigue status, and pain', 'Patient satisfaction', 'QoL and patient satisfaction', 'Quality of life and patient satisfaction', 'fatigue', 'appearance of the abdominal scar', 'Patient satisfaction regarding surgery', 'global health status', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",359.0,0.378031,"In the subgroup analysis of patients without adjuvant chemotherapy, patients in the SPLS group presented with significantly better global health status (p = 0.017), fatigue (p = 0.047), and pain (p = 0.005) scores and tended to have improved physical (p = 0.055), emotional (p = 0.064), and social (p = 0.081) functioning, with marginal significance at 1 month postoperatively, compared to those in the MPLS group.","[{'ForeName': 'Byung Mo', 'Initials': 'BM', 'LastName': 'Kang', 'Affiliation': 'Department of Surgery, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Yoon Suk', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, Seoul St. Mary's Hospital College of Medicine, The Catholic University Hospital, Seoul, Korea.""}, {'ForeName': 'Ji Hoon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': ""Department of Surgery, College of Medicine, Incheon St. Mary's Hospital, The Catholic University Hospital, Incheon, Korea.""}, {'ForeName': 'Hyung Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ""Department of Surgery, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University Hospital, Seoul, Korea.""}, {'ForeName': 'Sang Chul', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University Hospital, Daejeon, Korea.""}, {'ForeName': 'Chang Woo', 'Initials': 'CW', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, 892 Dongnam-ro, Gangdong-gu, Seoul, 05278, Korea.'}, {'ForeName': 'Sang Woo', 'Initials': 'SW', 'LastName': 'Lim', 'Affiliation': 'Department of Surgery, Hallym Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea.'}, {'ForeName': 'Jun Gi', 'Initials': 'JG', 'LastName': 'Kim', 'Affiliation': ""Department of Surgery, Seoul St. Mary's Hospital College of Medicine, The Catholic University Hospital, Seoul, Korea.""}, {'ForeName': 'Suk-Hwan', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, 892 Dongnam-ro, Gangdong-gu, Seoul, 05278, Korea. leeshdr@gmail.com.'}]",Surgical endoscopy,['10.1007/s00464-020-08128-9']
1720,33141278,Cholangioscopy- versus fluoroscopy-guided transpapillary mapping biopsy for preoperative evaluation of extrahepatic cholangiocarcinoma: a prospective randomized crossover study.,"BACKGROUND
To evaluate the lateral extent of extrahepatic cholangiocarcinoma, the value of cholangioscopy-guided mapping biopsy (CMB) compared with that of fluoroscopy-guided mapping biopsy (FMB) remains unknown. The aim of this study was to compare these two techniques.
METHODS
In this prospective, randomized, crossover study, both CMB and FMB techniques were performed for all patients in a randomized order. Target sites for the mapping biopsy were determined based on resection lines of possible surgical procedures. At least two biopsy strokes were attempted at each target site. The primary outcome was the rate of site-based successful biopsies, which was defined as acquisition of epithelium-containing material appropriate for diagnosing benignancy/malignancy from each site, regardless of amount of materials obtained from the same site.
RESULTS
Between September 2016 and October 2018, 28 patients (16 distal bile duct cancer and 12 perihilar bile duct cancer) were enrolled and divided into two groups of 14 patients: CMB first and FMB first. Although all 118 target sites could be approached using CMB, FMB forceps reached only 71% of them with significantly poor accessibility to the B2/3 confluence. Since several materials were too small and did not contain epithelium, the overall rates of site-based successful biopsies were 78% (92/118) using CMB and 64% (76/118) using FMB (P = 0.031).
CONCLUSIONS
The rate of site-based successful biopsies using CMB was significantly higher than that using FMB when evaluated using specimens obtained from several biopsy strokes.",2020,The rate of site-based successful biopsies using CMB was significantly higher than that using FMB when evaluated using specimens obtained from several biopsy strokes.,"['extrahepatic cholangiocarcinoma', 'Between September 2016 and October 2018, 28 patients (16 distal bile duct cancer and 12 perihilar bile duct cancer']","['fluoroscopy-guided mapping biopsy (FMB', 'cholangioscopy-guided mapping biopsy (CMB', 'Cholangioscopy- versus fluoroscopy-guided transpapillary mapping biopsy']","['rate of site-based successful biopsies using CMB', 'rate of site-based successful biopsies, which was defined as acquisition of epithelium-containing material appropriate for diagnosing benignancy/malignancy from each site, regardless of amount of materials obtained from the same site', 'overall rates of site-based successful biopsies']","[{'cui': 'C3805278', 'cui_str': 'Extrahepatic Cholangiocarcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}]","[{'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0940834', 'cui_str': 'Cholangioscopy'}, {'cui': 'C0442370', 'cui_str': 'Transpapillary approach - duodenal'}]","[{'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0940834', 'cui_str': 'Cholangioscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0014609', 'cui_str': 'Epithelium'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0314833,The rate of site-based successful biopsies using CMB was significantly higher than that using FMB when evaluated using specimens obtained from several biopsy strokes.,"[{'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, 983-0824, Japan. t-ogawa@openhp.or.jp.'}, {'ForeName': 'Yoshihide', 'Initials': 'Y', 'LastName': 'Kanno', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, 983-0824, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Koshita', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, 983-0824, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Masu', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, 983-0824, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kusunose', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, 983-0824, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, 983-0824, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Yonamine', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, 983-0824, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, 983-0824, Japan.'}, {'ForeName': 'Toji', 'Initials': 'T', 'LastName': 'Murabayashi', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, 983-0824, Japan.'}, {'ForeName': 'Fumisato', 'Initials': 'F', 'LastName': 'Kozakai', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, 983-0824, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Endo', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, 983-0824, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Noda', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, 983-0824, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, 983-0824, Japan.'}]",Surgical endoscopy,['10.1007/s00464-020-08141-y']
1721,33141327,"Impact of a school-based water, sanitation and hygiene programme on children's independent handwashing and toothbrushing habits: a cluster-randomised trial.","OBJECTIVES
To explore whether a school-based water, sanitation and hygiene programme, which includes group hygiene activities, contributes to the formation of independent handwashing and toothbrushing habits among Filipino children.
METHODS
In this cluster-randomised trial, twenty primary schools were randomly allocated to the intervention or control arm. Intervention schools received group handwashing facilities and implemented daily group handwashing and toothbrushing activities. A soap use to toilet event ratio was calculated to measure children's independent handwashing behaviour after toilet use, and dental plaque accumulation on Monday morning was measured as a proxy indicator for children's independent toothbrushing behaviour at home.
RESULTS
Four months after implementation, handwashing and toothbrushing behaviours did not significantly differ between intervention and control schools. The mean soap use in intervention schools and control schools was 0.41 g and 0.30 g per toilet event, respectively (p = 0.637). Compared to baseline, mean plaque scores reduced by 4.2% and 3.5% in intervention and control schools, respectively (p = 0.857).
CONCLUSIONS
Although health benefits have been established, school-based group handwashing and toothbrushing may not be sufficient to increase children's uptake of independent hygiene behaviours.",2020,"Compared to baseline, mean plaque scores reduced by 4.2% and 3.5% in intervention and control schools, respectively (p = 0.857).
","['twenty primary schools', ""children's independent handwashing and toothbrushing habits""]","['school-based water, sanitation and hygiene programme', 'group handwashing facilities and implemented daily group handwashing and toothbrushing activities']","['handwashing and toothbrushing behaviours', 'mean plaque scores']","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0493894,"Compared to baseline, mean plaque scores reduced by 4.2% and 3.5% in intervention and control schools, respectively (p = 0.857).
","[{'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Duijster', 'Affiliation': 'Department of Social Dentistry, Academic Centre for Dentistry Amsterdam, University of Amsterdam and VU Universiteit Amsterdam, Amsterdam, The Netherlands. D.Duijster@acta.nl.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Buxton', 'Affiliation': 'Disease Control Department, School of Hygiene and Tropical Medicine London, London, UK.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Benzian', 'Affiliation': 'Department of Epidemiology and Health Promotion, WHO Collaborating Center for Quality Improvement and Evidence-based Dentistry, College of Dentistry, New York University, New York, USA.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Dimaisip-Nabuab', 'Affiliation': 'Gesellschaft für Internationale Zusammenarbeit (GIZ), Metro Manila, Philippines.'}, {'ForeName': 'Bella', 'Initials': 'B', 'LastName': 'Monse', 'Affiliation': 'Gesellschaft für Internationale Zusammenarbeit (GIZ), Metro Manila, Philippines.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Volgenant', 'Affiliation': 'Department of Preventive Dentistry, Academic Centre for Dentistry Amsterdam, University of Amsterdam and VU Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dreibelbis', 'Affiliation': 'Disease Control Department, School of Hygiene and Tropical Medicine London, London, UK.'}]",International journal of public health,['10.1007/s00038-020-01514-z']
1722,33141398,IMPROV-ED trial: eHealth programme for faster recovery and reduced healthcare utilisation after CABG.,"BACKGROUND
After coronary artery bypass grafting (CABG), healthcare utilisation is high and is partly unplanned. eHealth applications have been proposed to reduce healthcare consumption and to enable patients to get actively involved in their recovery. This way, healthcare expenses can be reduced and the quality of care can be improved.
OBJECTIVES
We aim to evaluate whether the use of an eHealth programme can reduce unplanned healthcare utilisation and improve mental and physical health in the first 6 weeks after discharge in patients who underwent CABG. In addition, patient satisfaction and use of the eHealth programme will be evaluated.
METHODS
For this single-centre randomised controlled trial, at least 280 patients referred for CABG will be included at the preoperative outpatient clinic and randomised to an intervention or control group. The intervention group will have access to an eHealth programme, which consists of online educational videos developed by the Dutch Heart Foundation and postoperative video consultations with a physician. The control group will receive standard care and will not have access to the eHealth programme. The primary endpoint is healthcare utilisation; other endpoints include anxiety, duration of recovery, quality of life and patient satisfaction. Participants will complete several questionnaires at 6 time points during the study.
RESULTS
Patient enrolment started in February 2020 and completion of the follow-up period is expected in August 2021.
CONCLUSION
This randomised trial was initiated to test the hypothesis that patients who are partaking in our eHealth programme use less unplanned care and experience a better quality of life, less anxiety and a faster recovery than controls.",2020,We aim to evaluate whether the use of an eHealth programme can reduce unplanned healthcare utilisation and improve mental and physical health in the first 6 weeks after discharge in patients who underwent CABG.,"['patients who underwent CABG', '280\xa0patients referred for CABG will be included at the preoperative outpatient clinic and randomised to an intervention or control group', 'patients who are partaking in our eHealth programme use less unplanned care and experience a\xa0better quality of life, less anxiety and a\xa0faster recovery than controls']","['eHealth programme', 'eHealth programme, which consists of online educational videos developed by the Dutch Heart Foundation and postoperative video consultations with a\xa0physician', 'coronary artery bypass grafting (CABG']","['unplanned healthcare utilisation and improve mental and physical health', 'healthcare utilisation; other endpoints include anxiety, duration of recovery, quality of life and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",,0.147565,We aim to evaluate whether the use of an eHealth programme can reduce unplanned healthcare utilisation and improve mental and physical health in the first 6 weeks after discharge in patients who underwent CABG.,"[{'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'van Steenbergen', 'Affiliation': 'Catharina Heart Center, Catharina Hospital, Eindhoven, The Netherlands. gijs.v.steenbergen@catharinaziekenhuis.nl.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'van Veghel', 'Affiliation': 'Catharina Heart Center, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ter Woorst', 'Affiliation': 'Catharina Heart Center, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'van Lieshout', 'Affiliation': 'Dutch Heart Foundation, The Hague, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dekker', 'Affiliation': 'Catharina Heart Center, Catharina Hospital, Eindhoven, The Netherlands.'}]",Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation,['10.1007/s12471-020-01508-9']
1723,33141417,A secondary analysis of a randomised controlled trial to investigate the effect of Tai Chi on the instrumented timed up and go test in people with mild to moderate dementia.,"BACKGROUND
Previous research has identified that Tai Chi is effective for reducing risk of falls and improving timed up and go scores. However, our previous research identified no-significant difference in time to complete the timed up and go test following a Tai Chi intervention in people with dementia.
AIM
To conduct a secondary analysis to extend our understanding of the effect of Tai Chi on the instrumented Timed Up and Go test.
METHODS
This is a secondary analysis of a randomised controlled trial set in the community. People with dementia, recruited from NHS databases, memory clinics, local charities and self-referral across the south of England, received either 20 weeks of Tai Chi plus normal care or normal care. Outcomes were assessed using the instrumented Timed Up and Go test, completed at baseline and after 6 months.
RESULTS
From 83 people with dementia volunteering for the study, 67 complete datasets were available for analysis. Within-group pairwise comparison across time revealed no-significant gains for any of the instrumented Timed Up and Go variables, and no-significant difference for between-group pairwise comparisons.
DISCUSSION
This suggests that Tai Chi had no effect on the instrumented Timed Up and Go in people with dementia. This lack of effect may be due to the lack of specificity of the training stimulus to the outcome measure.
CONCLUSION
Tai Chi had no effect on any instrumented Timed Up and Go variables, suggesting Tai Chi may not be best placed to enhance the sub-elements of the instrumented Timed Up and Go to reduce fall risk among community-dwelling people with dementia.
CLINICAL TRIAL REGISTRATION NUMBER
NCT02864056.",2020,"Within-group pairwise comparison across time revealed no-significant gains for any of the instrumented Timed Up and Go variables, and no-significant difference for between-group pairwise comparisons.
","['people with dementia', 'People with dementia, recruited from NHS databases, memory clinics, local charities and self-referral across the south of England, received either 20\xa0weeks of', '83 people with dementia volunteering for the study, 67 complete datasets were available for analysis', 'people with mild to moderate dementia']","['Tai Chi', 'Tai Chi plus normal care or normal care', 'Tai Chi intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0007962', 'cui_str': 'Charities'}, {'cui': 'C0237824', 'cui_str': 'Self-referral'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],83.0,0.108555,"Within-group pairwise comparison across time revealed no-significant gains for any of the instrumented Timed Up and Go variables, and no-significant difference for between-group pairwise comparisons.
","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Department of Rehabilitation and Sport Sciences, Faculty of Health and Social Sciences, Bournemouth University, Poole, BH1 3LT, UK. jwilliams@bournemouth.ac.uk.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Nyman', 'Affiliation': 'Department of Psychology and Ageing & Dementia Research Centre, Faculty of Science and Technology, Bournemouth University, Poole, UK.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01741-7']
1724,33141477,A Comparison of Triamcinolone Acetonide Econazole Cream and Nystatin Suspension in Treatment of Otomycosis.,"OBJECTIVES/HYPOTHESIS
To compare the efficacy and adverse effects of triamcinolone acetonide econazole cream and nystatin suspension in the treatment of otomycosis, and to determine the clinical features, predisposing factors, and etiology of otomycosis.
STUDY DESIGN
A prospective study.
METHODS
A prospective clinical trial was conducted on 786 patients diagnosed with otomycosis. The study population was randomly divided into two treatment groups of triamcinolone acetonide econazole cream (TAEC) and nystatin suspension in a 1:1 ratio. After clearing all fungal deposits in the external auditory canal, the antimycotic drugs were locally applied for at least 2 weeks. The efficacy and adverse effects were compared between the two antifungal reagents by statistical analysis. Meanwhile, patient clinical data were collected to find out the clinical features, predisposing factors, and etiology.
RESULTS
Pruritis was the most common symptom and Aspergillus niger was the leading fungal pathogen. There was high association (44.5%) of otomycosis with a history of unclean ear picking. The cure rate was 97.6% in the TAEC group and 73.5% in the nystatin group (P < .01). Treatment with TAEC resulted in 2.4% of patients complaining of discomforts (irritant dermatitis, otalgia, or headache) versus 59.8% of patients complaining discomforts treated with nystatin (P < .01). The residue rate of antifungals was 1.9% in the TAEC group and 89.9% in the nystatin group (P < .01) at the end of treatment.
CONCLUSIONS
Thoroughly cleaning of the external auditory canal followed by local use of TAEC under endotoscope is an effective, convenient, and well-tolerated treatment for otomycosis.
LEVEL OF EVIDENCE
1 Laryngoscope, 2020.",2020,The cure rate was 97.6% in the TAEC group and 73.5% in the nystatin group (P < .01).,['786 patients diagnosed with otomycosis'],"['triamcinolone acetonide econazole cream (TAEC) and nystatin suspension', 'nystatin', 'triamcinolone acetonide econazole cream and nystatin suspension', 'TAEC', 'Triamcinolone Acetonide Econazole Cream and Nystatin Suspension']","['complaining of discomforts (irritant dermatitis, otalgia, or headache', 'efficacy and adverse effects', 'cure rate', 'residue rate of antifungals']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029895', 'cui_str': 'Otomycosis'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0013547', 'cui_str': 'Econazole'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0028741', 'cui_str': 'Nystatin'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0162823', 'cui_str': 'Irritant contact dermatitis'}, {'cui': 'C0013456', 'cui_str': 'Otalgia'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0003308', 'cui_str': 'Antifungal-containing product'}]",786.0,0.0251331,The cure rate was 97.6% in the TAEC group and 73.5% in the nystatin group (P < .01).,"[{'ForeName': 'Qingguo', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Hanqi', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liyan', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liangqiang', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Tianyou Hospital Affiliated to Wuhan University of Science & Technology, Wuhan, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Laboratory Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",The Laryngoscope,['10.1002/lary.29190']
1725,33136654,Blood pressure-lowering efficacy of a 6-week multi-modal isometric exercise intervention.,"Isometric exercise training (IET) is an effective method for reducing resting blood pressure (BP). To date, no research studies have been conducted using multiple exercises within an IET intervention. Previous research has suggested that varied exercise programmes may have a positive effect on adherence. Therefore, this randomized controlled study aimed to investigate the BP-lowering efficacy of a multi-modal IET (MIET) intervention in healthy young adults. Twenty healthy participants were randomized to an MIET [n = 10; four women; SBP 117.9 ± 6.9 mmHg; DBP 66.3 ± 5.1 mmHg] or control (CON) group (n = 10; five women; SBP, 123.3 ± 10.4 mmHg; DBP, 77.3 ± 6.7 mmHg). The MIET group completed three sessions per week of 4, 2-min isometric contractions, with a 1-min rest between each contraction, for 6 weeks. Resting BP and heart rate (HR) were measured at baseline and post-intervention. Pre-to-post intervention within-group reductions in resting BP were observed (SBP: 5.3 ± 6.1 mmHg, DBP: 3.4 ± 3.7 mmHg, MAP: 4.0 ± 3.9 mmHg, HR: 4.8 ±6 .6 bpm), although clinically relevant (≥2 mmHg), these changes were not statistically significant. Significant (p < 0.05) between-group differences were found between the intervention and control groups, indicating that the MIET intervention has a greater BP-lowering effect compared to control. The clinically relevant post-training reductions in resting BP suggest that MIET may be a promising additional IET method for hypertension prevention. These findings; however, must be interpreted with caution due to the small sample size and the non-clinical cohort.",2020,"Significant (p < 0.05) between-group differences were found between the intervention and control groups, indicating that the MIET intervention has a greater BP-lowering effect compared to control.","['healthy young adults', 'Twenty healthy participants']","['multi-modal IET (MIET) intervention', 'MIET intervention', 'Isometric exercise training (IET', 'control (CON', 'multi-modal isometric exercise intervention']","['Resting BP and heart rate (HR', 'Blood pressure-lowering efficacy', 'resting blood pressure (BP', 'BP-lowering efficacy', 'resting BP', 'BP-lowering effect']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",20.0,0.0448757,"Significant (p < 0.05) between-group differences were found between the intervention and control groups, indicating that the MIET intervention has a greater BP-lowering effect compared to control.","[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Baddeley-White', 'Affiliation': 'Department is the School of Human Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, London UK.'}, {'ForeName': 'Cayla N', 'Initials': 'CN', 'LastName': 'Wood', 'Affiliation': 'Department of Kinesiology, Faculty of Human Kinetics, University of Windsor, Windsor, Ontario, Canada.'}, {'ForeName': 'Cheri L M', 'Initials': 'CLM', 'LastName': 'McGowan', 'Affiliation': 'Department of Kinesiology, Faculty of Human Kinetics, University of Windsor, Windsor, Ontario, Canada.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Howden', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Charlotte, Charlotte, North Carolina.'}, {'ForeName': 'Ebony C', 'Initials': 'EC', 'LastName': 'Gaillard', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Charlotte, Charlotte, North Carolina.'}, {'ForeName': 'Benjamin D H', 'Initials': 'BDH', 'LastName': 'Gordon', 'Affiliation': 'Department of Exercise and Rehabilitative Sciences, Slippery Rock University, Slippery Rock, Pennsylvania, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Goss-Sampson', 'Affiliation': 'Department is the School of Human Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, London UK.'}, {'ForeName': 'Ian L', 'Initials': 'IL', 'LastName': 'Swaine', 'Affiliation': 'Department is the School of Human Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, London UK.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000492']
1726,30967104,"The relationship between diet, energy balance and fertility in men.","Research conducted in recent years provides more and more evidence that diet can have a significant impact on male fertility. The aim of the study was to analyze the relationship between diet, energy balance and fertility in men. A comprehensive literature search of published studies in various languages, was carried out in electronic databases. The direct analysis included 96 works published between 2008 and 2018, including 12 randomized controlled trials and 23 systematic reviews and meta-analyses. A strong adherence to a healthy dietary pattern is positively correlated with total sperm count, progressive motility and total motile sperm count (all p < 0.05). However, attention is drawn to the fact that foods that are considered ""healthy"" can sometimes contain a significant amount of pollution, which negatively affect the semen parameters. An adequate intake of antioxidants or their supplementation have been quite effective in the prevention and treatment of male infertility. The improvement of pregnancy rate after antioxidant therapy ranged in various studies from 11% to 41%. An important problem, however, may be choosing the right dose of the supplement or finding an appropriate combination of antioxidants that may be more effective than any single antioxidant. The normalization of men's body weight is beneficial for the quality of sperm and the concentration of male reproductive hormones. Further, long-term studies require the assessment of the impact of drastic weight loss after bariatric surgery on male fertility.",2020,"A strong adherence to a healthy dietary pattern is positively correlated with total sperm count, progressive motility and total motile sperm count (all p < 0.05).","['men', '96 works published between 2008 and 2018, including 12 randomized controlled trials and 23 systematic reviews and meta-analyses']",[],"['total sperm count, progressive motility and total motile sperm count', 'drastic weight loss', 'pregnancy rate']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1955832', 'cui_str': 'Review, Systematic'}, {'cui': 'C0282458', 'cui_str': 'Meta-Analysis'}]",[],"[{'cui': 'C0429846', 'cui_str': 'Sperm total count procedure'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",,0.0369802,"A strong adherence to a healthy dietary pattern is positively correlated with total sperm count, progressive motility and total motile sperm count (all p < 0.05).","[{'ForeName': 'Edyta', 'Initials': 'E', 'LastName': 'Suliga', 'Affiliation': 'Department of Nutrition and Dietetics, Institute of Public Health, Faculty of Medicine and Health Sciences, Jan Kochanowski University, Kielce, Poland.'}, {'ForeName': 'Stanisław', 'Initials': 'S', 'LastName': 'Głuszek', 'Affiliation': 'Department of Surgery and Surgical Nursing with the Scientific Research Laboratory, Institute of Medical Sciences, Jan Kochanowski University, Kielce, Poland.'}]",International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition,['10.1024/0300-9831/a000577']
1727,33135666,Effects of a Combination of Three-Dimensional Virtual Reality and Hands-on Horticultural Therapy on Institutionalized Older Adults' Physical and Mental Health: Quasi-Experimental Design.,"BACKGROUND
Institutionalized older adults have limited ability to engage in horticultural activities that can improve their physical and mental health.
OBJECTIVE
This study explored the effects of a combination of 3D virtual reality and horticultural therapy on institutionalized older adults' physical and mental health.
METHODS
The study used a quasi-experimental design. A total of 106 older adults from 2 long-term care facilities were recruited and assigned to the experimental (n=59) or control (n=47) group. The experimental participants received a 9-week intervention. Both groups completed 3 assessments: at baseline, after the intervention, and 2 months later. The outcome variables included health status, meaning in life, perceived mattering, loneliness, and depression.
RESULTS
The experimental group demonstrated significantly improved health status (P<.001), meaning in life (P<.001), and perceived mattering (P<.001) as well as significantly reduced depression (P<.001) and loneliness (P<.001) compared to the control group immediately after the intervention; these effects persisted for up to 2 months.
CONCLUSIONS
This study verified the beneficial effects of a combination of 3D virtual reality and hands-on horticultural therapy on older adults' health. These results could support the future successful implementation of similar programs for institutionalized older adults on a larger scale.",2020,"The experimental group demonstrated significantly improved health status (P<.001), meaning in life (P<.001), and perceived mattering (P<.001) as well as significantly reduced depression (P<.001) and loneliness (P<.001) compared to the control group immediately after the intervention; these effects persisted for up to 2 months.
","['institutionalized older adults', '106 older adults from 2 long-term care facilities were recruited and assigned to the experimental (n=59) or control (n=47) group', ""institutionalized older adults' physical and mental health"", ""Institutionalized Older Adults' Physical and Mental Health"", ""older adults' health"", 'Institutionalized older adults']","['Combination of Three-Dimensional Virtual Reality and Hands-on Horticultural Therapy', '3D virtual reality and horticultural therapy', '3D virtual reality and hands-on horticultural therapy']","['reduced depression (P<.001) and loneliness', 'health status, meaning in life, perceived mattering, loneliness, and depression', 'health status (P<.001), meaning in life']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0454057', 'cui_str': 'Horticultural therapy'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",106.0,0.0289225,"The experimental group demonstrated significantly improved health status (P<.001), meaning in life (P<.001), and perceived mattering (P<.001) as well as significantly reduced depression (P<.001) and loneliness (P<.001) compared to the control group immediately after the intervention; these effects persisted for up to 2 months.
","[{'ForeName': 'Tsung-Yi', 'Initials': 'TY', 'LastName': 'Lin', 'Affiliation': 'Department of Marketing and Distribution Management, Hsing Wu University, Taipei, Taiwan.'}, {'ForeName': 'Chiu-Mieh', 'Initials': 'CM', 'LastName': 'Huang', 'Affiliation': 'Institute of Clinical Nursing, School of Nursing, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Pei', 'Initials': 'HP', 'LastName': 'Hsu', 'Affiliation': 'Institute of Clinical Nursing, School of Nursing, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Jung-Yu', 'Initials': 'JY', 'LastName': 'Liao', 'Affiliation': 'Institute of Population Health Sciences, National Health Research Institutes, Miaoli, Taiwan.'}, {'ForeName': 'Vivian Ya-Wen', 'Initials': 'VY', 'LastName': 'Cheng', 'Affiliation': 'PureAroma Healing Academy, Taipei, Taiwan.'}, {'ForeName': 'Shih-Wen', 'Initials': 'SW', 'LastName': 'Wang', 'Affiliation': 'Department of Health Promotion and Health Education, College of Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Jong-Long', 'Initials': 'JL', 'LastName': 'Guo', 'Affiliation': 'Department of Health Promotion and Health Education, College of Education, National Taiwan Normal University, Taipei, Taiwan.'}]",Journal of medical Internet research,['10.2196/19002']
1728,33135774,Evaluation of temperature rise in the pulp during various IPR techniques-an in vivo study.,"BACKGROUND
Non-extraction treatment protocol has gained a lot of popularity over extraction for orthodontic treatment. Interproximal enamel reduction is one such method that makes it possible to do orthodontic treatment without extractions. This procedure, which can be done by various techniques, leads to a rise in the temperature of the pulp of the teeth. Previously, studies have been done which have evaluated the temperature changes inside the pulp chamber of extracted teeth, during interproximal enamel reduction. However, no documented literature exists that has evaluated these changes in the live pulp of the teeth whilst interproximal enamel reduction (IPR) is being performed. Therefore, this study aimed to evaluate the temperature changes inside the live pulp of the teeth during various interproximal enamel reduction techniques in vivo.
AIMS
Evaluation of temperature rise in the pulp during various interproximal enamel reduction techniques, done in vivo.
MATERIAL AND METHOD
The study was performed on patients for whom extraction of premolars had been advised for their orthodontic treatment. Fifty-one premolar teeth were randomly divided into three groups of IPR, i.e. using airotor and bur, handheld metal strip and orthodontic IPR kit (oscillating system). IPR was performed on the mesial and distal sides after access opening, temperature change was recorded during IPR and the readings were compared. The Shapiro-Wilk test was utilized for checking whether the data satisfied the requirement of normal distribution.
RESULTS
The highest temperature rise was seen in group 1 in which interproximal enamel reduction was performed using airotor and bur. The minimum temperature rise was observed in group 2 in which interproximal enamel reduction was done using the handheld metal strip, whereas the temperature rise observed in group 3, in which interproximal enamel reduction was done using IPR kit, was between the range of group 1 and group 3. The temperature change was in the following order-group 1 (2.08 °C) > group 3 (1.22 °C) > group 2 (0.52 °C).
CONCLUSION
None of the methods used to perform interproximal enamel reduction caused a temperature increase more than 5.5 °C, beyond which pulp necrosis may occur. Therefore, all three methods used in the study for IPR were found to be safe.",2020,"None of the methods used to perform interproximal enamel reduction caused a temperature increase more than 5.5 °C, beyond which pulp necrosis may occur.","['Fifty-one premolar teeth', 'patients for whom extraction of premolars had been advised for their orthodontic treatment']","['airotor and bur, handheld metal strip and orthodontic IPR kit (oscillating system']","['IPR', 'minimum temperature rise', 'highest temperature rise', 'temperature change']","[{'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}]","[{'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0450031', 'cui_str': 'Temperature change'}]",51.0,0.0167436,"None of the methods used to perform interproximal enamel reduction caused a temperature increase more than 5.5 °C, beyond which pulp necrosis may occur.","[{'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Banga', 'Affiliation': 'Manav Rachna Dental College, Sector 43, Suraj Kund, Badkhal Road, Faridabad, Haryana, 121004, India. kiran.banga1992@gmail.com.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Arora', 'Affiliation': 'Manav Rachna Dental College, Sector 43, Suraj Kund, Badkhal Road, Faridabad, Haryana, 121004, India.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Kannan', 'Affiliation': 'Manav Rachna Dental College, Sector 43, Suraj Kund, Badkhal Road, Faridabad, Haryana, 121004, India.'}, {'ForeName': 'Ashish Kumar', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Manav Rachna Dental College, Sector 43, Suraj Kund, Badkhal Road, Faridabad, Haryana, 121004, India.'}, {'ForeName': 'Abhita', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Manav Rachna Dental College, Sector 43, Suraj Kund, Badkhal Road, Faridabad, Haryana, 121004, India.'}]",Progress in orthodontics,['10.1186/s40510-020-00340-6']
1729,33135865,Bioequivalence of Metformin in Ertugliflozin/Metformin Fixed-Dose Combination Tablets to Canadian-Sourced Metformin Coadministered With Ertugliflozin Under Fasted and Fed States.,"A fixed-dose combination (FDC) product of a selective sodium-glucose cotransporter 2 inhibitor ertugliflozin and immediate-release metformin is approved for type 2 diabetes mellitus in the United States, European Union countries, Canada, and other countries. Two studies were conducted to assess the bioequivalence of metformin in the ertugliflozin/metformin FDC tablets to the corresponding doses of Canadian-sourced metformin (Glucophage) coadministered with ertugliflozin. Both studies were phase 1 randomized, open-label, 2-period, single-dose crossover studies (n = 32) in which healthy subjects received an ertugliflozin/metformin FDC tablet (2.5/500 mg or 7.5/850 mg) and the respective doses of the individual components (ertugliflozin coadministered with Canadian-sourced metformin) under fasted (n = 18) or fed (n = 14) conditions. Blood samples were collected 72 hours postdose to determine metformin concentrations. The 90% confidence intervals were within the bioequivalence acceptance criteria for the adjusted geometric mean ratios (FDC:coadministered) for metformin area under the plasma concentration-time curve from time zero to time t, where t is the last point with a measurable concentration and peak observed plasma concentration for both dose strengths under fasted and fed conditions. All study medications were well tolerated. Bioequivalence was demonstrated for the metformin component of the ertugliflozin/metformin FDC tablets and the corresponding doses of the Canadian-sourced metformin coadministered with ertugliflozin.",2020,Bioequivalence was demonstrated for the metformin component of the ertugliflozin/metformin FDC tablets and the corresponding doses of the Canadian-sourced metformin coadministered with ertugliflozin.,[],"['Metformin Coadministered With Ertugliflozin', 'ertugliflozin/metformin FDC tablet', 'metformin coadministered with ertugliflozin', 'metformin', 'individual components (ertugliflozin coadministered with Canadian-sourced metformin', 'selective sodium-glucose cotransporter 2 inhibitor ertugliflozin and immediate-release metformin', 'Metformin in Ertugliflozin/Metformin', 'metformin (Glucophage) coadministered with ertugliflozin']",['tolerated'],[],"[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C4535599', 'cui_str': 'metformin and ertugliflozin'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",[],,0.0243442,Bioequivalence was demonstrated for the metformin component of the ertugliflozin/metformin FDC tablets and the corresponding doses of the Canadian-sourced metformin coadministered with ertugliflozin.,"[{'ForeName': 'Vikas Kumar', 'Initials': 'VK', 'LastName': 'Dawra', 'Affiliation': 'Pfizer Inc., New York, New York, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Pelletier', 'Affiliation': 'Pfizer, Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Matschke', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Pfizer, Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Pfizer, Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Merck and Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Krishna', 'Affiliation': 'Merck and Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Sahasrabudhe', 'Affiliation': 'Pfizer, Inc., Groton, Connecticut, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.884']
1730,33135866,Randomized trial assessing impact of probiotic supplementation on gut microbiome and clinical outcome from targeted therapy in metastatic renal cell carcinoma.,"Studies suggest a link between the gut microbiome and metastatic renal cell carcinoma (mRCC) outcomes, including evidence that mRCC patients possess a lower abundance of Bifidobacterium spp. compared to healthy adults. We sought to assess if a Bifidobacterium-containing yogurt product could modulate the gut microbiome and clinical outcome from vascular endothelial growth factor-tyrosine kinase inhibitors (VEGF-TKIs). mRCC patients initiating VEGF-TKIs, regardless of the line of therapy, were randomized to probiotic-supplemented (two 4 oz. servings of the probiotic yogurt product daily) or probiotic-restricted arms. Stool samples were collected prior to therapy and at weeks 2, 3, 4, and 12. Microbiome composition was assessed using whole-metagenome sequencing. A total of 20 patients were randomized. Bifidobacterium animalis, the active ingredient of the probiotic supplement, reached detectable levels in all patients in the probiotic-supplemented arm versus two patients in the probiotic-restricted arm. Clinical benefit rate was similar in probiotic-supplemented versus probiotic-restricted arms (70% vs. 80%, p = 0.606). Linear discriminant analysis (LDA) effect size analysis of MetaPhIAn2 abundance data predicted 25 enriched species demonstrating an LDA score >3 in either clinical benefit or no clinical benefit. In patients with clinical benefit (vs. no clinical benefit), Barnesiella intestinihominis and Akkermansia muciniphila were significantly more abundant (p = 7.4 × 10 -6 and p = 5.6 × 10 -3 , respectively). This is the first prospective randomized study demonstrating modulation of the gut microbiome with a probiotic in mRCC. Probiotic supplementation successfully increased the Bifidobacterium spp. levels. Analysis of longitudinal stool specimens identified an association between B. intestinihominis, A. muciniphila, and clinical benefit with therapy. Trial Registration: NCT02944617.",2020,"Analysis of longitudinal stool specimens identified an association between B. intestinihominis, A. muciniphila, and clinical benefit with therapy.","['metastatic renal cell carcinoma', '20 patients were randomized']","['Bifidobacterium-containing yogurt product', 'Probiotic supplementation', 'probiotic supplementation']","['Bifidobacterium spp', 'Barnesiella intestinihominis and Akkermansia muciniphila', 'Clinical benefit rate', 'Microbiome composition']","[{'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C1490590', 'cui_str': 'Akkermansia muciniphila'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",20.0,0.0783121,"Analysis of longitudinal stool specimens identified an association between B. intestinihominis, A. muciniphila, and clinical benefit with therapy.","[{'ForeName': 'Nazli', 'Initials': 'N', 'LastName': 'Dizman', 'Affiliation': 'Department of Medical Oncology and Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Hsu', 'Affiliation': 'Department of Medical Oncology and Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Paulo G', 'Initials': 'PG', 'LastName': 'Bergerot', 'Affiliation': 'Department of Medical Oncology and Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Gillece', 'Affiliation': 'Pathogen and Microbiome Division, Translational Genomics Research Institute North, Flagstaff, AZ, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Folkerts', 'Affiliation': 'Pathogen and Microbiome Division, Translational Genomics Research Institute North, Flagstaff, AZ, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Reining', 'Affiliation': 'Pathogen and Microbiome Division, Translational Genomics Research Institute North, Flagstaff, AZ, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Trent', 'Affiliation': 'Translational Genomics Research Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Highlander', 'Affiliation': 'Pathogen and Microbiome Division, Translational Genomics Research Institute North, Flagstaff, AZ, USA.'}, {'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Department of Medical Oncology and Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}]",Cancer medicine,['10.1002/cam4.3569']
1731,33135935,Effects of contemporary dance and physiotherapy intervention on balance and postural control in Parkinson's disease.,"PURPOSE
To describe the effects of a contemporary dance program, combined with conventional physiotherapy, on postural control, satisfaction and adherence in mild-moderate Parkinson's disease (PD) patients.
METHODS
A withdrawal/reversion test with three intervention periods. Each period lasts for two months: physiotherapy, physiotherapy + dance and withdrawing dance and continuing with the physiotherapy sessions. Berg Balance Scale (BBS), Timed Up & Go test (TUG), Sensory Organization Test (SOT), Motor Control Test (MCT) and Rhythmic Weigh Shift (RWS) were assessed at T1 (baseline), T2 (post-physiotherapy treatment), T3 (post-physiotherapy and dance) and T4 (post-physiotherapy). A satisfaction questionnaire and adherence were registered.
RESULTS
27 patients (67.32 ± 6.14 yrs) completed the study. Statistical analysis revealed differences between T2-T3 ( p = 0.027), T2-T4 ( p = 0.029), T1-T3 ( p = 0.010) and T1-T4 ( p = 0.008) for BBS; and between T1-T2 ( p = 0.037), T1-T3 ( p = 0.005), T1-T4 ( p = 0.004), T2-T3 ( p = 0.022) and T2-T4 ( p = 0.041) for TUG. Significant differences for CES ( p < 0.001), VEST ( p = 0.024) and strategy ( p = 0.011) were observed, but not for MCT. Lateromedial velocity ( p = 0.003) and anteroposterior velocity ( p < 0.001) were significant for RWT. Patients showed a high level of satisfaction and adherence.
CONCLUSIONS
A short 8-weeks contemporary dance program plus combined physiotherapy shows benefits in functional mobility and balance, with a high degree of satisfaction and adherence in PD. IMPLICATIONS FOR REHABILITATION Contemporary dance, combined with physiotherapy, is a useful therapeutic tool to treat balance disorders and postural control in people with PD. A short 8-weeks contemporary dance program plus combined physiotherapy shows high satisfaction in people with PD. Contemporary dance, combined with physiotherapy, shows high adherence in people with mild-moderate PD to treat postural control.",2020,"Significant differences for CES ( p < 0.001), VEST ( p = 0.024) and strategy ( p = 0.011) were observed, but not for MCT.","[""Parkinson's disease"", ""mild-moderate Parkinson's disease (PD) patients"", 'people with PD', '27 patients (67.32\u2009±\u20096.14 yrs) completed the study', 'people with mild-moderate PD to treat postural control']","['T1-T4', 'contemporary dance program, combined with conventional physiotherapy', 'contemporary dance and physiotherapy intervention', 'physiotherapy, physiotherapy\u2009+\u2009dance and withdrawing dance and continuing with the physiotherapy sessions', 'T2-T4']","['CES', 'anteroposterior velocity', 'balance and postural control', 'satisfaction questionnaire and adherence', 'Lateromedial velocity', 'high level of satisfaction and adherence', 'Berg Balance Scale (BBS), Timed Up & Go test (TUG), Sensory Organization Test (SOT), Motor Control Test (MCT) and Rhythmic Weigh Shift (RWS']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]","[{'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4720873', 'cui_str': 'Sensory organization test'}, {'cui': 'C4720933', 'cui_str': 'Motor control test'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]",27.0,0.108134,"Significant differences for CES ( p < 0.001), VEST ( p = 0.024) and strategy ( p = 0.011) were observed, but not for MCT.","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Valverde-Guijarro', 'Affiliation': 'Escuela Internacional de Doctorado, Universidad Rey Juan Carlos (URJC), Madrid, Spain.'}, {'ForeName': 'Isabel María', 'Initials': 'IM', 'LastName': 'Alguacil-Diego', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Faculty of Health Sciences, Universidad Rey Juan Carlos (URJC), Madrid, Spain.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Vela-Desojo', 'Affiliation': 'Neurology Unit, Hospital Universitario Fundación Alcorcón, Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cano-de-la-Cuerda', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Faculty of Health Sciences, Universidad Rey Juan Carlos (URJC), Madrid, Spain.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1839973']
1732,33136005,A randomized comparison of Coronary Stents according to Short or Prolonged durations of Dual Antiplatelet Therapy in patients with Acute Coronary Syndromes: a pre-specified analysis of the SMART-DATE trial.,"AIMS
We sought to compare biodegradable-polymer biolimus-eluting stents(BP-BES) with durable-polymer everolimus-eluting(DP-EES) and zotarolimus-eluting stents(DP-ZES) in patients with acute coronary syndrome(ACS) according to different duration of dual antiplatelet therapy(DAPT).
METHODS AND RESULTS
In the SMART-DATE trial, 2712 patients with ACS underwent randomization for allocation of DAPT (6-month [n=1357] or 12-month or longer [n=1355]) and type of stents (BP-BES [n=901]), DP-EES [n=904], or DP-ZES [n=907]). At 18 months, primary endpoint (a composite of cardiac death, myocardial infarction, or stent thrombosis) was 2.6% with BP-BES, 2.0% with DP-EES, and 2.1% with DP-ZES (HR 1.29, 95% CI 0.70-2.39, p =0.42 for BP-BES vs. DP-EES and HR 1.23, 95% CI 0.67-2.26, p =0.50 for BP-BES vs. DP-ZES). The treatment effect of BP-BES for the primary endpoint was consistent among patients receiving 6-month DAPT as well as those receiving 12-month or longer DAPT (BP-BES vs. DP-EES, p interaction =0.48 and BP-BES vs. DP-ZES, p interaction =0.87). After excluding 179 patients (101 in the BP-BES group) who did not receive allocated DES, per-protocol analysis showed similar results.
CONCLUSIONS
The risk of a composite of cardiac death, myocardial infarction, or stent thrombosis was not significantly different between patients receiving BP-BES vs. DP-EES or DP-ZES across short or prolonged duration of DAPT after ACS.",2020,"The risk of a composite of cardiac death, myocardial infarction, or stent thrombosis was not significantly different between patients receiving BP-BES vs. DP-EES or DP-ZES across short or prolonged duration of DAPT after ACS.","['patients with Acute Coronary Syndromes', 'patients with acute coronary syndrome(ACS', '2712 patients with ACS underwent randomization for allocation of DAPT (6-month [n=1357] or 12-month or longer [n=1355]) and type of stents (BP-BES [n=901']","['DP-EES [n=904], or DP-ZES', 'Dual Antiplatelet Therapy', 'Coronary Stents', 'biodegradable-polymer biolimus-eluting stents(BP-BES) with durable-polymer everolimus-eluting(DP-EES) and zotarolimus-eluting stents(DP-ZES']","['composite of cardiac death, myocardial infarction, or stent thrombosis', 'risk of a composite of cardiac death, myocardial infarction, or stent thrombosis', 'BP-BES']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1700035', 'cui_str': 'Zotarolimus'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]",2712.0,0.0722826,"The risk of a composite of cardiac death, myocardial infarction, or stent thrombosis was not significantly different between patients receiving BP-BES vs. DP-EES or DP-ZES across short or prolonged duration of DAPT after ACS.","[{'ForeName': 'Woo Jin', 'Initials': 'WJ', 'LastName': 'Jang', 'Affiliation': 'Ewha Womans University College of medicine, Seoul Hospital, Seoul, Korea.'}, {'ForeName': 'Jin Bae', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Young Bin', 'Initials': 'YB', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Ki-Hong', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Seung-Hyuk', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Woo Jung', 'Initials': 'WJ', 'LastName': 'Chun', 'Affiliation': ''}, {'ForeName': 'Ju Hyeon', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': ''}, {'ForeName': 'Ik Hyun', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Joon-Hyung', 'Initials': 'JH', 'LastName': 'Doh', 'Affiliation': ''}, {'ForeName': 'Jin-Ok', 'Initials': 'JO', 'LastName': 'Jeong', 'Affiliation': ''}, {'ForeName': 'Jong-Seon', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hyeon-Cheol', 'Initials': 'HC', 'LastName': 'Gwon', 'Affiliation': ''}, {'ForeName': 'Joo-Yong', 'Initials': 'JY', 'LastName': 'Hahn', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00556']
1733,33136053,Integrating a Mobile Health Device Into a Community Youth Mental Health Team to Manage Severe Mental Illness: Protocol for a Randomized Controlled Trial.,"BACKGROUND
Symptoms of mental illness are often triggered by stress, and individuals with mental illness are sensitive to these effects. The development of mobile health (mHealth) devices allows continuous recording of biometrics associated with activity, sleep, and arousal. Deviations in these measures could indicate a stressed state requiring early intervention. This paper describes a protocol for integrating an mHealth device into a community mental health team to enhance management of severe mental illness in young adults.
OBJECTIVE
The aim of this study is to examine (1) whether an mHealth device integrated into a community mental health team can improve outcomes for young adults with severe mental illness and (2) whether the device detects periods of mental health versus deterioration.
METHODS
This study examines whether physiological information from an mHealth device prevents mental deterioration when shared with the participant and clinical team versus with the participant alone. A randomized controlled trial (RCT) will allocate 126 young adults from community mental health services for 6 months to standard case management combined with an integrated mHealth device (ie, physiological information is viewed by both participant and case manager: unWIRED intervention) or an unintegrated mHealth device (ie, participant alone self-monitors: control). Participants will wear the Empatica Embrace2 device, which continuously records electrodermal activity and actigraphy (ie, rest and activity). The study also examines whether the Embrace2 can detect periods of mental health versus deterioration. A variety of measurements will be taken, including physiological data from the Embrace2; participant and case manager self-report regarding symptoms, functioning, and quality of life; chart reviews; and ecological momentary assessments of stress in real time. Changes in each participant's Clinical Global Impression Scale scores will be assessed by blinded raters as the primary outcome. In addition, participants and case managers will provide qualitative data regarding their experience with the integrated mHealth device, which will be thematically analyzed.
RESULTS
The study has received ethical approval from the Western Sydney Local Health District Human Research Ethics Committee. It is due to start in October 2020 and conclude in October 2022.
CONCLUSIONS
The RCT will provide insight as to whether an integrated mHealth device enables case managers and participants to pre-emptively manage early warning signs and prevent relapse. We anticipate that unWIRED will enhance early intervention by improving detection of stress and allowing case managers and patients to better engage and respond to symptoms.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000642987; https://www.anzctr.org.au/ACTRN12620000642987.aspx.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
PRR1-10.2196/19510.",2020,"We anticipate that unWIRED will enhance early intervention by improving detection of stress and allowing case managers and patients to better engage and respond to symptoms.
","['young adults', 'young adults with severe mental illness and (2', '126 young adults from community mental health services for 6 months to']","['standard case management combined with an integrated mHealth device (ie, physiological information is viewed by both participant and case manager: unWIRED intervention) or an unintegrated mHealth device (ie, participant alone self-monitors: control', 'mHealth device integrated into a community mental health team', 'ANZCTR']","['Clinical Global Impression Scale scores', 'electrodermal activity and actigraphy (ie, rest and activity', 'mental deterioration']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0009475', 'cui_str': 'Mental Health Services, Community'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0687694', 'cui_str': 'Case manager'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]",126.0,0.384448,"We anticipate that unWIRED will enhance early intervention by improving detection of stress and allowing case managers and patients to better engage and respond to symptoms.
","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'Western Sydney Local Health District Mental Health Service, Sydney, NSW, Australia.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Kotze', 'Affiliation': 'Rivendell Child Adolescent and Family Unit, Sydney, Australia.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ramos', 'Affiliation': 'School of Computer Science, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Casties', 'Affiliation': 'Westmead Institute for Medical Research, Sydney, Australia.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Starling', 'Affiliation': 'Concord Centre for Mental Health, Sydney, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Harris', 'Affiliation': 'Western Sydney Local Health District Mental Health Service, Sydney, NSW, Australia.'}]",JMIR research protocols,['10.2196/19510']
1734,33136047,Effects of 50- and 70-Gy radiation doses on polymethyl methacrylate denture bases.,"The aim of this study was to evaluate the flexural strength and Knoop microhardness of the polymethyl methacrylate (PMMA) used in dental prostheses after receiving therapeutic radiation doses of 50 and 70 Gy. Thirty-six acrylic resin plates measuring 65.0 × 10.0 × 3.3 mm were fabricated and polymerized using a microwave. The specimens were randomly divided into 3 groups (n = 12): group 1, which received no radiation; group 2, which received 1 fractioned dose of 2 Gy per day, 5 days per week, for 5 weeks, totaling 50 Gy; and group 3, which received 1 fractioned dose of 2 Gy per day, 5 days per week, for 7 weeks, totaling 70 Gy. All specimens remained in ballistic gel at a temperature of 37°C throughout the study. Afterward, the specimens underwent flexural strength and Knoop microhardness tests. All data were analyzed using analysis of variance and Tukey post hoc test (P < 0.05). For flexural strength, there was a statistically significant difference between groups 1 and 2 (P = 0.012) and between groups 1 and 3 (P = 0.048). For Knoop microhardness, there was a difference between groups 1 and 2 (P = 0.001) and between groups 1 and 3 (P = 0.006). For both flexural strength and microhardness, groups 2 and 3 showed greater values than group 1. Therapeutic radiation doses of 50 and 70 Gy increased the flexural strength and Knoop microhardness of PMMA used in dental prostheses.",2020,"For Knoop microhardness, there was a difference between groups 1 and 2 (P = 0.001) and between groups 1 and 3 (P = 0.006).",['dental prostheses after receiving therapeutic radiation doses of 50 and 70 Gy'],"['polymethyl methacrylate (PMMA', '50- and 70-Gy radiation', 'no radiation']",['flexural strength'],"[{'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0005533', 'cui_str': 'Polymethyl methacrylate'}, {'cui': 'C1956312', 'cui_str': 'Gy Radiation'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C4704755', 'cui_str': 'Fracture Strength'}]",,0.0425855,"For Knoop microhardness, there was a difference between groups 1 and 2 (P = 0.001) and between groups 1 and 3 (P = 0.006).","[{'ForeName': 'Clóvis Lamartine', 'Initials': 'CL', 'LastName': 'de Moraes Melo Neto', 'Affiliation': ''}, {'ForeName': 'Sérgio', 'Initials': 'S', 'LastName': 'Sábio', 'Affiliation': ''}, {'ForeName': 'Gabriela Cristina', 'Initials': 'GC', 'LastName': 'Santin', 'Affiliation': ''}, {'ForeName': 'José Octávio Haggi', 'Initials': 'JOH', 'LastName': 'Rodrigues Ferreira', 'Affiliation': ''}, {'ForeName': 'Marcos Antonio', 'Initials': 'MA', 'LastName': 'da Silva', 'Affiliation': ''}, {'ForeName': 'Daniela Micheline', 'Initials': 'DM', 'LastName': 'Dos Santos', 'Affiliation': ''}, {'ForeName': 'Marcelo Coelho', 'Initials': 'MC', 'LastName': 'Goiato', 'Affiliation': ''}]",General dentistry,[]
1735,33136069,"Urinary tract infections in very low birthweight infants: A two-center analysis of microbiology, imaging and heart rate characteristics.","BACKGROUND
Increased understanding of characteristics of urinary tract infection (UTI) among very low birthweight infants (VLBW) might lead to improvement in detection and treatment. Continuous monitoring for abnormal heart rate characteristics (HRC) could provide early warning of UTIs.
OBJECTIVE
Describe the characteristics of UTI, including HRC, in VLBW infants.
METHODS
We reviewed records of VLBW infants admitted from 2005-2010 at two academic centers participating in a randomized clinical trial of HRC monitoring. Results of all urine cultures, renal ultrasounds (RUS), and voiding cystourethrograms (VCUG) were assessed. Change in the HRC index was analyzed before and after UTI.
RESULTS
Of 823 VLBW infants (27.7±2.9 weeks GA, 53% male), 378 had > / = 1 urine culture obtained. A UTI (≥10,000 CFU and >five days of antibiotics) was diagnosed in 80 infants, (10% prevalence, mean GA 25.8±2.0 weeks, 76% male). Prophylactic antibiotics were administered to 29 (36%) infants after UTI, of whom four (14%) had another UTI. Recurrent UTI also occurred in 7/51 (14%) of infants not on uroprophylaxis after their first UTI. RUS was performed after UTI in 78%, and hydronephrosis and other major anomalies were found in 19%. A VCUG was performed in 48% of infants and 18% demonstrated vesicoureteral reflux (VUR). The mean HRC rose and fell significantly in the two days before and after diagnosis of UTI.
CONCLUSIONS
UTI was diagnosed in 10% of VLBW infants, and the HRC index increased prior to diagnosis, suggesting that continuous HRC monitoring in the NICU might allow earlier diagnosis and treatment of UTI.",2020,Recurrent UTI also occurred in 7/51 (14%) of infants not on uroprophylaxis after their first UTI.,"['very low birthweight infants', 'very low birthweight infants (VLBW', 'VLBW infants admitted from 2005-2010 at two academic centers participating in a randomized clinical trial of HRC monitoring', '378 had > /\u200a=\u200a1 urine culture obtained', '823 VLBW infants (27.7±2.9 weeks GA, 53% male']",['Prophylactic antibiotics'],"['Recurrent UTI', 'Urinary tract infections', 'HRC index', 'urine cultures, renal ultrasounds (RUS), and voiding cystourethrograms (VCUG', 'mean HRC', 'RUS', 'vesicoureteral reflux (VUR']","[{'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0430404', 'cui_str': 'Urine culture'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}]","[{'cui': 'C0262655', 'cui_str': 'Recurrent urinary tract infection'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0430404', 'cui_str': 'Urine culture'}, {'cui': 'C0203408', 'cui_str': 'Echography of kidney'}, {'cui': 'C0203123', 'cui_str': 'Voiding urethrocystography'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042580', 'cui_str': 'Vesicoureteric reflux'}]",,0.119617,Recurrent UTI also occurred in 7/51 (14%) of infants not on uroprophylaxis after their first UTI.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Aviles-Otero', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ransom', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Charlton', 'Affiliation': 'Department of Pediatrics, Division of Nephrology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Sullivan', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Fairchild', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Virginia, Charlottesville, VA, USA.'}]",Journal of neonatal-perinatal medicine,['10.3233/NPM-200513']
1736,33136072,Effect of robot-assisted gait training on motor functions in adolescent and young adult patients with bilateral spastic cerebral palsy: A randomized controlled trial.,"BACKGROUND
Robot-assisted gait training (RAGT) allows an intensive gait training in patients with cerebral palsy (CP). There are few evidences on the effectiveness of RAGT in adults with CP.
OBJECTIVE
To assess the effect of RAGT on gross motor function in adolescent and adult patients with bilateral spastic CP and to compare the effect of RAGT with conventional kinesiotherapy.
METHODS
Forty-seven patients (mean age 21.2±5.33 years) with bilateral spastic CP were divided into two groups. Twenty-one patients underwent 20 therapeutic units of RAGT and 26 patients underwent 20 therapeutic units of conventional therapy/training (CON). The following parameters were evaluated before (V1) and after the therapy (V2): dimension A (lying and rolling), B (sitting), C (crawling and kneeling), D (standing), E (walking, running and jumping) of the Gross Motor Function Measure (GMFM-88). In patients in the experimental RAGT group, these parameters were also evaluated 3-4 months later (V3).
RESULTS
Comparing the mean improvements in endpoints in both groups (RAGT vs. CON) after 20 TUs, we observed the statistically significant difference (p < 0.001) and large effect size in all GMFM dimensions and total GMFM improvement in favour of the RAGT group. In RAGT patients, the improvement persisted even 3-4 months after RAGT (p < 0.001).
CONCLUSION
We demonstrated that the intensive RAGT regimen is more effective than conventional therapy in terms of improvements in gross motor functions in adolescent and adult patients with bilateral spastic CP.",2020,"In RAGT patients, the improvement persisted even 3-4 months after RAGT (p < 0.001).
","['adolescent and adult patients with bilateral spastic CP', 'adolescent and young adult patients with bilateral spastic cerebral palsy', 'Forty-seven patients (mean age 21.2±5.33 years) with bilateral spastic CP', 'patients with cerebral palsy (CP', 'Twenty-one patients underwent 20 therapeutic units of RAGT and 26 patients underwent', 'adults with CP']","['robot-assisted gait training', '20 therapeutic units of conventional therapy/training (CON', 'Robot-assisted gait training (RAGT', 'intensive gait training', 'RAGT']","['motor functions', 'GMFM dimensions and total GMFM improvement', 'dimension A (lying and rolling), B (sitting), C (crawling and kneeling), D (standing), E (walking, running and jumping) of the Gross Motor Function Measure (GMFM-88']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3838784', 'cui_str': 'Bilateral cerebral palsy'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0235042', 'cui_str': 'Does crawl'}, {'cui': 'C1260920', 'cui_str': 'Kneeling'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",47.0,0.0286321,"In RAGT patients, the improvement persisted even 3-4 months after RAGT (p < 0.001).
","[{'ForeName': 'Stanislava', 'Initials': 'S', 'LastName': 'Klobucká', 'Affiliation': 'Rehabilitation Centre Harmony, Bratislava, Slovakia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Klobucký', 'Affiliation': 'Slovak Academy of Sciences, Institute for Sociology, Bratislava, Slovakia.'}, {'ForeName': 'Branislav', 'Initials': 'B', 'LastName': 'Kollár', 'Affiliation': '1st Department of Neurology, Faculty of Medicine, Comenius University Bratislava, Bratislava, Slovakia.'}]",NeuroRehabilitation,['10.3233/NRE-203102']
1737,33136074,"Effect of trunk stabilization exercise on abdominal muscle thickness, balance and gait abilities of patients with hemiplegic stroke: A randomized controlled trial.","BACKGROUND
Trunk stability has been identified as an important prerequisite of functional movement.
OBJECTIVE
To investigate the effectiveness of core muscle contraction training on abdominal muscle thickness, balance, and gait ability in stroke patients.
METHODS
Thirty patients with stroke were randomly assigned to two experimental groups and a control group. All groups received conventional therapeutic exercise program for six weeks. The experimental groups additionally trained trunk stability exercise with abdominal hollowing or bracing maneuvers within training time. Primary outcome measures were evaluated abdominal muscle thickness using the sonography. Secondary outcome measures were evaluated by the Functional Reach Test (FRT), Berg Balance Scale (BBS), 10-meter walk test (10MWT), and Timed Up and Go test (TUG).
RESULTS
Compared with the control group, the effect of trunk stability training for the experimental groups on the abdominal muscles thickness change was observed (p < 0.05). The values in balance and gait measures, BBS, FRT, 10MWT, and TUG, showed significant improvement after the intervention periods (p < 0.05), although no significant differences were found in scores of gait and balance scales among groups.
CONCLUSIONS
Trunk stability training with selective abdominal muscles activation has beneficial effects on abdominal muscles, balance, and mobility in stroke patients. Our findings might provide support for introducing stroke rehabilitation.",2020,"The values in balance and gait measures, BBS, FRT, 10MWT, and TUG, showed significant improvement after the intervention periods (p < 0.05), although no significant differences were found in scores of gait and balance scales among groups.
","['stroke patients', 'patients with hemiplegic stroke', 'Thirty patients with stroke']","['trained trunk stability exercise with abdominal hollowing or bracing maneuvers within training time', 'trunk stability training', 'core muscle contraction training', 'conventional therapeutic exercise program', 'trunk stabilization exercise']","['abdominal muscle thickness using the sonography', 'abdominal muscle thickness, balance and gait abilities', 'abdominal muscle thickness, balance, and gait ability', 'scores of gait and balance scales', 'abdominal muscles thickness change', 'values in balance and gait measures, BBS, FRT, 10MWT, and TUG', 'Functional Reach Test (FRT), Berg Balance Scale (BBS), 10-meter walk test (10MWT), and Timed Up and Go test (TUG']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C0000739', 'cui_str': 'Skeletal muscle structure of abdomen'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",30.0,0.0312319,"The values in balance and gait measures, BBS, FRT, 10MWT, and TUG, showed significant improvement after the intervention periods (p < 0.05), although no significant differences were found in scores of gait and balance scales among groups.
","[{'ForeName': 'Ji-Yeon', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Dawoori Rehabilitation Hospital, Cheonahn, Chungnam, Republic of Korea.'}, {'ForeName': 'Jeongwoo', 'Initials': 'J', 'LastName': 'Jeon', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Sunmoon University, Asan-si, Republic of Korea.'}, {'ForeName': 'Dong-Yeop', 'Initials': 'DY', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Sunmoon University, Asan-si, Republic of Korea.'}, {'ForeName': 'JiHoen', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Sunmoon University, Asan-si, Republic of Korea.'}, {'ForeName': 'Jaeho', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Sunmoon University, Asan-si, Republic of Korea.'}, {'ForeName': 'Jinseop', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Sunmoon University, Asan-si, Republic of Korea.'}]",NeuroRehabilitation,['10.3233/NRE-203133']
1738,33136077,Low frequency transcranial magnetic stimulation in subacute ischemic stroke: Number of sessions that altered cortical excitability.,"BACKGROUND
Cortical reorganization between both cerebral hemispheres plays an important role in regaining the affected upper extremity motor function post-stroke.
OBJECTIVES
The purpose of the current study was to investigate the recommended number of contra-lesion low frequency repetitive transcranial magnetic stimulation (LF-rTMS) sessions that could enhance cortical reorganization post-stroke.
METHODS
Forty patients with right hemiparetic subacute ischemic stroke with an age range between 50-65 yrs were randomly assigned into two equal groups: control (GA) and study (GB) groups. Both groups were treated with a selected physical therapy program for the upper limb. Sham and real contra-lesion LF-rTMS was conducted for both groups daily for two consecutive weeks. Sequential changes of cortical excitability were calculated by the end of each session.
RESULTS
The significant enhancement in the cortical excitability was observed at the fourth session in favor of the study group (GB). Sequential rate of change in cortical excitability was significant for the first eight sessions. From the ninth session onwards, no difference could be detected between groups.
CONCLUSION
The pattern of recovery after stroke is extensive and not all factors could be controlled. Application of LF-rTMS in conjugation with a selected physical therapy program for the upper limb from four to eight sessions seems to be efficient.",2020,"From the ninth session onwards, no difference could be detected between groups.
","['Forty patients with right hemiparetic subacute ischemic stroke with an age range between 50-65\u200ayrs', 'subacute ischemic stroke']","['selected physical therapy program', 'Sham and real contra-lesion LF-rTMS', 'repetitive transcranial magnetic stimulation (LF-rTMS) sessions', 'LF-rTMS', 'Low frequency transcranial magnetic stimulation']","['Sequential rate of change in cortical excitability', 'cortical excitability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}]",40.0,0.0352333,"From the ninth session onwards, no difference could be detected between groups.
","[{'ForeName': 'Mohammed S', 'Initials': 'MS', 'LastName': 'El-Tamawy', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Moshera H', 'Initials': 'MH', 'LastName': 'Darwish', 'Affiliation': 'Department of Neuromuscular Disorders and its Surgery, Faculty of Physical Therapy, Cairo University, Egypt.'}, {'ForeName': 'Saly H', 'Initials': 'SH', 'LastName': 'Elkholy', 'Affiliation': 'Department of Clinical Neurophysiology, Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Engy BadrEldin S', 'Initials': 'EBS', 'LastName': 'Moustafa', 'Affiliation': 'Department of Neuromuscular Disorders and its Surgery, Faculty of Physical Therapy, Cairo University, Egypt.'}, {'ForeName': 'Shimaa T', 'Initials': 'ST', 'LastName': 'Abulkassem', 'Affiliation': 'Department of Basic Science, Faculty of Physical Therapy, Cairo University, Egypt.'}, {'ForeName': 'Heba A', 'Initials': 'HA', 'LastName': 'Khalifa', 'Affiliation': 'Department of Neuromuscular Disorders and its Surgery, Faculty of Physical Therapy, Cairo University, Egypt.'}]",NeuroRehabilitation,['10.3233/NRE-203156']
1739,33136159,A Randomized Trial of Caspofungin vs Triazoles Prophylaxis for Invasive Fungal Disease in Pediatric Allogeneic Hematopoietic Cell Transplant.,"BACKGROUND
Children and adolescents undergoing allogeneic hematopoietic cell transplantation (HCT) are at high risk for invasive fungal disease (IFD).
METHODS
This multicenter, randomized, open-label trial planned to enroll 560 children and adolescents (3 months to <21 years) undergoing allogeneic HCT between April 2013 and September 2016. Eligible patients were randomly assigned to antifungal prophylaxis with caspofungin or a center-specific comparator triazole (fluconazole or voriconazole). Prophylaxis was administered from day 0 of HCT to day 42 or discharge. The primary outcome was proven or probable IFD at day 42 as adjudicated by blinded central review. Exploratory analysis stratified this evaluation by comparator triazole.
RESULTS
A planned futility analysis demonstrated a low rate of IFD in the comparator triazole arm, so the trial was closed early. A total of 290 eligible patients, with a median age of 9.5 years (range 0.3-20.7), were randomized to caspofungin (n = 144) or a triazole (n = 146; fluconazole, n = 100; voriconazole, n = 46). The day 42 cumulative incidence of proven or probable IFD was 1.4% (95% confidence interval [CI], 0.3%-5.4%) in the caspofungin group vs 1.4% (95% CI, 0.4%-5.5%) in the triazole group (P = .99, log-rank test). When stratified by specific triazole, there was no significant difference in proven or probable IFD at day 42 between caspofungin vs fluconazole (1.0%, 95% CI, 0.1%-6.9%, P = .78) or caspofungin vs voriconazole (2.3%, 95% CI, 0.3%-15.1%, P = .69).
CONCLUSIONS
In pediatric HCT patients, prophylaxis with caspofungin did not significantly reduce the cumulative incidence of early proven or probable IFD compared with triazoles. Future efforts to decrease IFD-related morbidity and mortality should focus on later periods of risk.
TRIAL REGISTRATION
NCT01503515.",2020,"When stratified by specific triazole, there was no significant difference in proven or probable IFD at day 42 between caspofungin vs fluconazole (1.0%, 95% CI, 0.1%-6.9%, P = .78) or caspofungin vs voriconazole (2.3%, 95% CI, 0.3%-15.1%, P = .69).
","['Pediatric Allogeneic Hematopoietic Cell Transplant', 'Eligible patients', 'Children and adolescents undergoing', '290 eligible patients, with a median age of 9.5 years (range 0.3-20.7', '560 children and adolescents (3 months to <21 years) undergoing allogeneic HCT between April 2013 and September 2016']","['caspofungin', 'antifungal prophylaxis with caspofungin or a center-specific comparator triazole (fluconazole or voriconazole', 'triazole (n\u2005=\u2005146; fluconazole, n\u2005=\u2005100; voriconazole, n\u2005=\u200546', 'allogeneic hematopoietic cell transplantation (HCT', 'Caspofungin vs Triazoles Prophylaxis', 'fluconazole']","['cumulative incidence of proven or probable IFD', 'proven or probable IFD', 'cumulative incidence of early proven or probable IFD']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0206152', 'cui_str': 'Cell Transplants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0537894', 'cui_str': 'Caspofungin'}, {'cui': 'C0877136', 'cui_str': 'Antifungal prophylaxis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040880', 'cui_str': 'Triazole'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1262313', 'cui_str': 'Invasive fungal infection'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",290.0,0.202241,"When stratified by specific triazole, there was no significant difference in proven or probable IFD at day 42 between caspofungin vs fluconazole (1.0%, 95% CI, 0.1%-6.9%, P = .78) or caspofungin vs voriconazole (2.3%, 95% CI, 0.3%-15.1%, P = .69).
","[{'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Dvorak', 'Affiliation': 'Division of Pediatric Allergy, Immunology and Bone Marrow Transplant, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Fisher', 'Affiliation': ""Division of Pediatrics Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Esbenshade', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Nieder', 'Affiliation': 'Division of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center, Tampa, Florida, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': 'Division of Haematology Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Steinbach', 'Affiliation': 'Division of Pediatric Infectious Diseases, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Ha', 'Initials': 'H', 'LastName': 'Dang', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Doojduen', 'Initials': 'D', 'LastName': 'Villaluna', 'Affiliation': ""Children's Oncology Group, Monrovia, California, USA.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, City of Hope, Duarte, California, USA.'}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'Skeens', 'Affiliation': ""Department of Hematology/Oncology, Nationwide Children's Hospital, Columbus, Ohio, USA.""}, {'ForeName': 'Theoklis E', 'Initials': 'TE', 'LastName': 'Zaoutis', 'Affiliation': ""Division of Pediatrics Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Sung', 'Affiliation': 'Division of Haematology Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada.'}]",Journal of the Pediatric Infectious Diseases Society,['10.1093/jpids/piaa119']
1740,33136172,"Correction to: A placebo‑controlled, double‑blind, randomized study of recombinant thrombomodulin (ART‑123) to prevent oxaliplatin‑induced peripheral neuropathy.","In the Original publication of the article, the authors found an error in the ""Results"" section under the heading ""Abstract"". The corrected text is given below.",2020,"In the Original publication of the article, the authors found an error in the ""Results"" section under the heading ""Abstract"".",[],"['placebo‑controlled', 'recombinant thrombomodulin (ART‑123']",[],[],"[{'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}]",[],,0.2402,"In the Original publication of the article, the authors found an error in the ""Results"" section under the heading ""Abstract"".","[{'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Kotaka', 'Affiliation': 'Gastrointestinal Cancer Center, Sano Hospital, 2-5-1 Shimizugaoka, Tarumi-ku, Kobe-shi, Hyogo, 655-0031, Japan. tomomakotaka6410@yahoo.co.jp.'}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Anesthesiology, Shimane University Faculty of Medicine, 89-1 Enyacho, Izumo City, Shimane, 693-8501, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterological Surgery, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki-shi, Hyogo, 660-8511, Japan.'}, {'ForeName': 'Hironaga', 'Initials': 'H', 'LastName': 'Satake', 'Affiliation': 'Department of Medical Oncology, Kobe City Medical Center General Hospital, 2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan.'}, {'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, 1-8-1 Kishinoura, Yahatanishi-ku, Kitakyusyu-shi, Fukuoka, 806-8501, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medical Oncology, Tonan Hospital, Kita 4-jo Nishi 7-chome 3-8, Chuo-ku, Sapporo-shi, Hokkaido, 060-0004, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, 1-5-54 Ujinakanda, Minami-ku, Hiroshima-shi, Hiroshima, 734-8530, Japan.'}, {'ForeName': 'Toshiyoshi', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan.'}, {'ForeName': 'Tsunekazu', 'Initials': 'T', 'LastName': 'Mizushima', 'Affiliation': 'Department of Gastrointestinal Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Harihara', 'Affiliation': 'Department of Surgery, NTT Medical Center Tokyo, 5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo, 141-8625, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Nagata', 'Affiliation': 'Department of Surgery, Kitakyushu General Hospital, 1-1 Higashijono-machi, Kokurakita-ku, Kitakyushu, 802-8517, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kurihara', 'Affiliation': 'Department of Surgery, Nerima General Hospital, 1-24-1 Asahigaoka, Nerima-ku, Tokyo, 176-8530, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan.'}, {'ForeName': 'Genichi', 'Initials': 'G', 'LastName': 'Kusakawa', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Yugo', 'Initials': 'Y', 'LastName': 'Uchida', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Mikihiro', 'Initials': 'M', 'LastName': 'Takamoto', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kimoto', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04185-y']
1741,33136223,Six-minute walk test: prognostic value and effects of nebivolol versus placebo in elderly patients with heart failure from the SENIORS trial.,"BACKGROUND
There is limited information about the 6-min walk test (6MWT) in elderly patients with heart failure. We evaluated 6MWT and the effect of nebivolol on 6MWT from the SENIORS trial.
METHODS AND RESULTS
The SENIORS trial evaluated nebivolol versus placebo on death and hospitalisation in patients aged ≥ 70 years with heart failure. A total of 1982 patients undertook a 6MWT at baseline and 1716 patients at 6 months. Patients were divided into tertiles (≤ 200 m, 201 to ≤ 300 m and > 300 m) and to change in distance walked between baseline and 6 months (< 0 m, 0 to < 30 m and ≥ 30 m). The primary outcome was all-cause mortality and cardiovascular hospital admission. Secondary endpoint was all-cause mortality. Baseline walk distance of ≤ 200 m incurred a greater risk of the primary and secondary outcomes (HR 1.41, CI 95% 1.17-1.69, p < 0.001) and (HR 1.37, CI 95% 1.05-1.78, p = 0.019). A decline in walk distance over 6 months was associated with increased risk of clinical events. Nebivolol had no influence on change in walk distance over 6 months.
CONCLUSIONS
The 6MWT has prognostic utility in elderly patients. Those who walked less than 200 m were at highest risk. Nebivolol had no effect on 6MWT.",2020,"Baseline walk distance of ≤ 200 m incurred a greater risk of the primary and secondary outcomes (HR 1.41, CI 95% 1.17-1.69, p < 0.001) and (HR 1.37, CI 95% 1.05-1.78, p = 0.019).","['elderly patients with heart failure from the SENIORS trial', 'elderly patients', 'elderly patients with heart failure', '1982 patients undertook a 6MWT at baseline and 1716 patients at 6\xa0months', 'patients aged\u2009≥\u200970\xa0years with heart failure']","['6MWT', 'nebivolol', 'placebo', 'nebivolol versus placebo', '6-min walk test (6MWT', 'Nebivolol']","['walk distance', '6MWT', 'cause mortality', 'cause mortality and cardiovascular hospital admission', 'risk of clinical events', 'death and hospitalisation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0456590', 'cui_str': '1982'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0068475', 'cui_str': 'nebivolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",1982.0,0.338601,"Baseline walk distance of ≤ 200 m incurred a greater risk of the primary and secondary outcomes (HR 1.41, CI 95% 1.17-1.69, p < 0.001) and (HR 1.37, CI 95% 1.05-1.78, p = 0.019).","[{'ForeName': 'Marcelo C', 'Initials': 'MC', 'LastName': 'Shibata', 'Affiliation': 'University of Alberta, and Covenant Health, Misericordia Hospital, Suite 362, Heritage Medical Research Centre, Edmonton, AB, T6G 2C8, Canada. marcelo.shibata@ualberta.ca.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Curl-Roper', 'Affiliation': 'University of East Anglia and Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'Van Veldhuisen', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roughton', 'Affiliation': 'Novartis Campus, Basel, Switzerland.'}, {'ForeName': 'Andrew J S', 'Initials': 'AJS', 'LastName': 'Coats', 'Affiliation': 'Monash University, Melbourne, Australia.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Flather', 'Affiliation': 'University of East Anglia and Norfolk and Norwich University Hospital, Norwich, UK.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01768-w']
1742,33136226,Impact of the catechol-O-methyltransferase Val158Met polymorphism on the pharmacokinetics of L-dopa and its metabolite 3-O-methyldopa in combination with entacapone.,"In the pharmacotherapy of patients with Parkinson's disease (PD), entacapone reduces the peripheral metabolism of L-dopa to 3-O-methyldopa (3-OMD), thereby prolonging the half-life (t 1/2 ) of L-dopa and increasing the area under the concentration curve (AUC). The effect of entacapone on the pharmacokinetics of L-dopa differs between patients with high-activity (H/H) and low-activity (L/L) catechol-O-methyltransferase (COMT) Val158Met polymorphisms, but the effects are unclear in heterozygous (H/L) patients. 3-OMD has a detrimental effect and results in a poor response to L-dopa treatment in patients with PD; however, the influence of this polymorphism on the production of 3-OMD remains unknown. Therefore, the present study aimed to clarify the effect of the COMT Val158Met polymorphism on the concentrations of L-dopa and 3-OMD in the presence of entacapone. We performed an open-label, single-period, single-sequence crossover study at two sites in Japan. The study included 54 Japanese patients with PD, who underwent an acute L-dopa administration test with and without 100 mg entacapone on two different days. Entacapone increased L-dopa AUC 0-infinity by 1.59 ± 0.26-fold in the H/H group, which was significantly higher than that in the H/L (1.41 ± 0.36-fold) and L/L (1.28 ± 0.21-fold) groups (p < 0.05). The concurrent administration of L-dopa with entacapone suppressed the increase in 3-OMD levels compared with L-dopa alone in all genotypes. Our results suggest that the COMT Val158Met polymorphism may be an informative biomarker for individualized dose adjustment of COMT inhibitors in the treatment of PD.",2020,"Entacapone increased L-dopa AUC 0-infinity by 1.59 ± 0.26-fold in the H/H group, which was significantly higher than that in the H/L (1.41 ± 0.36-fold) and L/L (1.28 ± 0.21-fold) groups (p < 0.05).","['patients with PD', '54 Japanese patients with PD, who underwent an acute L-dopa administration test with and without 100\xa0mg entacapone on two different days', 'patients with high-activity (H/H) and low-activity (L/L) catechol-O-methyltransferase (COMT) Val158Met polymorphisms', ""patients with Parkinson's disease (PD""]","['catechol-O-methyltransferase Val158Met polymorphism', '3-OMD', 'Entacapone', 'entacapone']","['concentrations of L-dopa and 3-OMD', 'peripheral metabolism of L-dopa to 3-O-methyldopa (3-OMD', '3-OMD levels', 'L-dopa AUC 0-infinity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0165921', 'cui_str': 'entacapone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0047557', 'cui_str': '3-O-methyldopa'}, {'cui': 'C0165921', 'cui_str': 'entacapone'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0047557', 'cui_str': '3-O-methyldopa'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",54.0,0.0216638,"Entacapone increased L-dopa AUC 0-infinity by 1.59 ± 0.26-fold in the H/H group, which was significantly higher than that in the H/L (1.41 ± 0.36-fold) and L/L (1.28 ± 0.21-fold) groups (p < 0.05).","[{'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Hospital Pharmacy and Pharmacology, Asahikawa Medical University, Asahikawa, 078-8510, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Omura', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Kasamo', 'Affiliation': 'Institutional Research Office, Asahikawa Medical University, Asahikawa, 078-8510, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Kawata', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Yonezawa', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Taruno', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Kyoto University, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Hisako', 'Initials': 'H', 'LastName': 'Endo', 'Affiliation': 'Division of Neurology, Department of Internal Medicine, Asahikawa Medical University, Asahikawa, 078-8510, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Aizawa', 'Affiliation': 'Division of Neurology, Department of Internal Medicine, Asahikawa Medical University, Asahikawa, 078-8510, Japan.'}, {'ForeName': 'Nobukatsu', 'Initials': 'N', 'LastName': 'Sawamoto', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Kyoto University, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Matsubara', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Takahashi', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Kyoto University, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Tasaki', 'Affiliation': 'Department of Hospital Pharmacy and Pharmacology, Asahikawa Medical University, Asahikawa, 078-8510, Japan. tasakiy@asahikawa-med.ac.jp.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-020-02267-y']
1743,31961926,Baseline SUVmax did not predict histological transformation in follicular lymphoma in the phase 3 GALLIUM study.,"A minority of patients with follicular lymphoma (FL) undergo histological transformation (HT). This retrospective analysis of 549 patients from the phase 3 GALLIUM study (NCT01332968) assessed the relationship between maximum standardized uptake value (SUVmax) at baseline on positron emission tomography (PET) and HT risk. Previously untreated patients with high tumor burden grade 1-3a FL received obinutuzumab- or rituximab-based chemotherapy induction. The relationship between baseline SUVmax (bSUVmax) and HT risk was assessed using cutoff values for SUVmax >10 and >20. Overall, 15 of 549 (2.7%) patients with baseline PET scans experienced biopsy-confirmed HT (median follow-up, 59 months). More than 65% of patients had bSUVmax > 10, with 3.3% of these experiencing HT. Only 1 of 74 (1.4%) patients with bSUVmax > 20 underwent HT. Median bSUVmax in patients with HT vs without HT was 12.4 (range, 8.1-28.0) vs 11.8 (range, 3.1-64.4), respectively; median bSUVrange (the difference between bSUVmax of the most and least 18F-fluorodeoxyglucose-avid lymphoma sites) was 8.0 (range, 1.1-23.9) vs 7.1 (range, 0.0-59.8), respectively. There was no temporal relationship between bSUVmax and HT. Neither bSUVmax nor bSUVrange predicted HT in GALLIUM, suggesting that there may be little benefit in rebiopsy of lesions to exclude HT based on SUVmax alone before initiating therapy in patients with high tumor burden FL.",2020,"Median bSUVmax in patients with HT vs without HT was 12.4 (range, 8.1-28.0) vs 11.8 (range, 3.1-64.4), respectively; median bSUVrange (the difference between bSUVmax of the most and least 18F-fluorodeoxyglucose-avid lymphoma sites) was 8.0 (range, 1.1-23.9) vs 7.1 (range, 0.0-59.8), respectively.","['patients with high tumor burden FL', '549 patients from the phase 3 GALLIUM study (NCT01332968) assessed the', 'patients with follicular lymphoma (FL) undergo histological transformation (HT']",['obinutuzumab- or rituximab-based chemotherapy induction'],"['Median bSUVmax', 'baseline SUVmax (bSUVmax) and HT risk', 'median bSUVrange', 'relationship between maximum standardized uptake value (SUVmax) at baseline on positron emission tomography (PET) and HT risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0016980', 'cui_str': 'Gallium'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}]",549.0,0.113404,"Median bSUVmax in patients with HT vs without HT was 12.4 (range, 8.1-28.0) vs 11.8 (range, 3.1-64.4), respectively; median bSUVrange (the difference between bSUVmax of the most and least 18F-fluorodeoxyglucose-avid lymphoma sites) was 8.0 (range, 1.1-23.9) vs 7.1 (range, 0.0-59.8), respectively.","[{'ForeName': 'Farheen', 'Initials': 'F', 'LastName': 'Mir', 'Affiliation': 'Royal Marsden Hospital, Sutton, United Kingdom.'}, {'ForeName': 'Sally F', 'Initials': 'SF', 'LastName': 'Barrington', 'Affiliation': ""King's College London and Guy's and St Thomas' Positron Emission Tomography Centre, School of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Roche Products Ltd, Welwyn, United Kingdom.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Nielsen', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Sahin', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Meignan', 'Affiliation': 'Functional Imaging and Therapeutics Department, Hôpital Henri Mondor and Université Paris-Est Créteil, Créteil, France; and.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Trotman', 'Affiliation': 'Concord Repatriation General Hospital, University of Sydney, Concord, NSW, Australia.'}]",Blood,['10.1182/blood.2019001091']
1744,31996395,Response and outcomes after anti-CTLA4 versus anti-PD1 combined with stereotactic body radiation therapy for metastatic non-small cell lung cancer: retrospective analysis of two single-institution prospective trials.,"BACKGROUND
This study compared response rates and outcomes of combined radiotherapy and immunotherapy (iRT) based on the type of checkpoint inhibitor (anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) vs antiprogrammed death-1 (PD1)) for metastatic non-small cell lung cancer (mNSCLC).
METHODS
We retrospectively reviewed two prospective trials of radiation combined with anti-CTLA4 or anti-PD1 for patients with mNSCLC. Patients undergoing non-salvage stereotactic body radiation therapy (SBRT) to lung sites were selected from both trials and grouped by the immunotherapeutic compound received. Endpoints included in-field and out-of-field response rates, and overall response rate (complete or partial response) (all by response evaluation criteria in solid tumors). Progression-free survival (PFS) and overall survival (OS) were estimated with the Kaplan-Meier method.
RESULTS
Median follow-up times for the 33 patients (n=17 SBRT+anti-CTLA4, n=16 SBRT+anti-PD1) were 19.6 and 19.9 months. Response rates for out-of-field lesions were similar between anti-PD1 (37%) and anti-CTLA4 (24%) (p=0.054). However, global response rates for all lesions were 24% anti-CTLA4 vs 56% anti-PD1 (p=0.194). The PFS was 76% for anti-CTLA4 vs 94% anti-PD1 at 3 months, 52% vs 87% at 6 months, 31% vs 80% at 12 months, and 23% vs 63% at 18 months (p=0.02). Respective OS values were 76% vs 87% at 6 months, 47% vs 80% at 12 months, and 39% vs 66% at 18 months (p=0.08).
CONCLUSIONS
Both anti-CTLA4 and anti-PD1 agents prompt a similar degree of in-field and out-of-field responses after iRT, although the global response rate and PFS were statistically higher in the anti-PD1 cohort. Further dedicated study and biological mechanistic assessment is required.
TRIAL REGISTRATION NUMBERS
NCT02239900 and NCT02444741.",2020,"The PFS was 76% for anti-CTLA4 vs 94% anti-PD1 at 3 months, 52% vs 87% at 6 months, 31% vs 80% at 12 months, and 23% vs 63% at 18 months (p=0.02).","['metastatic non-small cell lung cancer (mNSCLC', 'metastatic non-small cell lung cancer', 'Patients undergoing non-salvage stereotactic body radiation therapy (SBRT) to lung sites', 'patients with mNSCLC']","['checkpoint inhibitor (anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) vs antiprogrammed death-1 (PD1', 'radiation combined with anti-CTLA4 or anti-PD1', 'combined radiotherapy and immunotherapy (iRT', 'anti-CTLA4 versus anti-PD1 combined with stereotactic body radiation therapy']","['Respective OS values', 'global response rates', 'field and out-of-field response rates, and overall response rate (complete or partial response', 'Response rates', 'PFS', 'Progression-free survival (PFS) and overall survival (OS', 'global response rate and PFS']","[{'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2350360', 'cui_str': 'CTLA4 protein, human'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0436241', 'cui_str': 'Combined radiotherapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0695337,"The PFS was 76% for anti-CTLA4 vs 94% anti-PD1 at 3 months, 52% vs 87% at 6 months, 31% vs 80% at 12 months, and 23% vs 63% at 18 months (p=0.02).","[{'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Menon', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, United States.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Verma', 'Affiliation': 'Department of radiation oncology, Allegheny General Hospital, Houston, Texas, United States.'}, {'ForeName': 'Chunxiao', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Department of Interventional Radiology, The University of Texas MD Anderson Cancer Center, Houston, China.'}, {'ForeName': 'Rishab', 'Initials': 'R', 'LastName': 'Ramapriyan', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, United States.'}, {'ForeName': 'Hampartsoum', 'Initials': 'H', 'LastName': 'Barsoumian', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, United States.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Younes', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, United States.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wasley', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, United States.'}, {'ForeName': 'Maria Angelica', 'Initials': 'MA', 'LastName': 'Cortez', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Welsh', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, United States JWelsh@mdanderson.org.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2019-000492']
1745,32237275,Comparison of delivered distending pressures in the oropharynx in preterm infant on bubble CPAP and on three different nasal interfaces.,"OBJECTIVE
To compare the level of continuous positive airway pressure (CPAP) delivered by three different CPAP delivery interfaces (RAM cannula system, Hudson prongs, and nasal mask) in preterm neonates with respiratory distress.
METHODS
Preterm neonates with gestation between 28 weeks and 34 weeks and birth weight more than or equal to 1000 g and requiring nasal CPAP for respiratory distress were eligible for the study. During the study period, consecutive infants requiring CPAP were started on Hudson prongs or RAM cannula or nasal mask in that order. We measured the mean oropharyngeal pressure, which approximates the applied CPAP level. Oropharyngeal pressures in the recruited neonates were measured between 24 and 48 hours of postnatal age, when stable and in sleep or quiet awake state. Comparison of the delivered oropharyngeal pressures when on three different nasal interfaces at the same set flow rate and at set CPAP of 5 cm or 6 cm of H 2 O was the primary outcome.
RESULTS
Data was analyzed from 30 neonates in each group. We found that measured oropharyngeal pressures were less than set CPAP level in all three studied interfaces. Maximum drop in oropharyngeal pressure was observed with use of RAM cannula with measured oropharyngeal pressures being 1.1 and 1.2 cm H 2 O less than set CPAP of 5 and 6 cm H 2 O respectively. Pharyngeal pressure best correlated to set CPAP level with the use of nasal mask.
CONCLUSION
None of the nasal interfaces delivered oropharyngeal pressure equivalent to the set CPAP. However, nasal mask delivered oropharyngeal pressure best matched to the set CPAP.",2020,Maximum drop in oropharyngeal pressure was observed with use of RAM cannula with measured oropharyngeal pressures being 1.1 and 1.2 cm H 2 O less than set CPAP of 5 and 6 cm,"['Oropharyngeal pressures in the recruited neonates were measured between 24 and 48\u2009hours of postnatal age, when stable and in sleep or quiet awake state', 'preterm neonates with respiratory distress', 'preterm infant on bubble CPAP and on three different nasal interfaces', 'Preterm neonates with gestation between 28 weeks and 34 weeks and birth weight more than or equal to 1000\u2009g and requiring nasal CPAP for respiratory distress were eligible for the study', '30 neonates in each group', 'consecutive infants requiring CPAP were started on Hudson prongs or']","['RAM cannula or nasal mask', 'RAM cannula', 'continuous positive airway pressure (CPAP) delivered by three different CPAP delivery interfaces (RAM cannula system, Hudson prongs, and nasal mask']","['oropharyngeal pressures', 'mean oropharyngeal pressure', 'oropharyngeal pressure']","[{'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0271276', 'cui_str': ""Stahli's line""}]","[{'cui': 'C0526951', 'cui_str': 'ramosetron hydrochloride'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C2711254', 'cui_str': 'Nasal mask'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0271276', 'cui_str': ""Stahli's line""}]","[{'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0692228,Maximum drop in oropharyngeal pressure was observed with use of RAM cannula with measured oropharyngeal pressures being 1.1 and 1.2 cm H 2 O less than set CPAP of 5 and 6 cm,"[{'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Department of Neonatology, Fernandez Hospital, Hyderabad, India.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murki', 'Affiliation': 'Department of Neonatology, Fernandez Hospital, Hyderabad, India.'}, {'ForeName': 'Shravani', 'Initials': 'S', 'LastName': 'Maram', 'Affiliation': 'Department of Neonatology, Fernandez Hospital, Hyderabad, India.'}, {'ForeName': 'Tejo', 'Initials': 'T', 'LastName': 'Pratap', 'Affiliation': 'Department of Neonatology, Fernandez Hospital, Hyderabad, India.'}, {'ForeName': 'Sai', 'Initials': 'S', 'LastName': 'Kiran', 'Affiliation': 'Department of Neonatology, Fernandez Hospital, Hyderabad, India.'}, {'ForeName': 'Vardhelli', 'Initials': 'V', 'LastName': 'Venkateshwarlu', 'Affiliation': 'Department of Neonatology, Fernandez Hospital, Hyderabad, India.'}, {'ForeName': 'Pawale', 'Initials': 'P', 'LastName': 'Dinesh', 'Affiliation': 'Department of Neonatology, Fernandez Hospital, Hyderabad, India.'}, {'ForeName': 'Dattatray', 'Initials': 'D', 'LastName': 'Kulkarni', 'Affiliation': 'Department of Neonatology, Fernandez Hospital, Hyderabad, India.'}, {'ForeName': 'Bhargavi', 'Initials': 'B', 'LastName': 'Kamineni', 'Affiliation': 'Department of Neonatology, Fernandez Hospital, Hyderabad, India.'}, {'ForeName': 'Anusha', 'Initials': 'A', 'LastName': 'T', 'Affiliation': 'Department of Neonatology, Fernandez Hospital, Hyderabad, India.'}, {'ForeName': 'Gurmeet', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'Head, Clinical Engineering & Infection Control, Fernandez Hospital, Hyderabad, India.'}]",Pediatric pulmonology,['10.1002/ppul.24752']
1746,32273102,Intrapatient Randomization to Study Strut Coverage in Polymer-Free Versus Biodegradable-Polymer Sirolimus-Eluting Stent Implantations.,,2020,,[],['Polymer-Free Versus Biodegradable-Polymer Sirolimus-Eluting Stent Implantations'],[],[],"[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",[],,0.0118309,,"[{'ForeName': 'Imanol', 'Initials': 'I', 'LastName': 'Otaegui', 'Affiliation': ''}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Pérez de Prado', 'Affiliation': ''}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Massotti', 'Affiliation': ''}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'López-Benito', 'Affiliation': ''}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': ''}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Martí', 'Affiliation': ''}, {'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Bellera', 'Affiliation': ''}, {'ForeName': 'Bernat', 'Initials': 'B', 'LastName': 'Serra', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'García Del Blanco', 'Affiliation': ''}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Ferreira González', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.11.020']
1747,32469095,Drug cost savings in phase III hematological oncology clinical trials in a university hospital.,"The rapid emergence of expensive anticancer therapies is leading to exponential growth in healthcare expenses. In clinical trials, most investigational drugs are provided free of charge by industrial and academic sponsors. This results in drug cost savings for healthcare payers, who are no longer charged with the cost of the standard-of-care treatment, which would have been administered outside the trial. This study aims to estimate drug cost savings resulting from patient enrolment in hematological oncology clinical trials, from a public payer perspective. Retrospective screening identified all patients with hematological malignancies included from 2011 to 2016 in a phase III trial and having received at least one sponsor-provided cycle. Drug cost savings were defined as the standard treatment costs not charged to the payer due to sponsor provision of treatment. For each patient, cost savings were determined by the number of cycles received in the trial and the cost of standard (control arm) treatment. Of the 345 patients included in eligible trials during study period, 272 received sponsor-provided drugs. Drug cost savings could be estimated for 177 patients (65.1%) included in 27 trials. Total cost savings were €5218 million (US$ 6804 million) for 1720 sponsor-provided cycles. Mean cost saving per patient was €19 182.7 ± 29 865.7 ($25 015.24 ± 39 478.25). Most cost-saving trials were industry-sponsored (77.8%), although academic trials generated 40.15% of total cost savings. Enrolling patients in clinical trials, whether industry-sponsored or academic, leads to substantial drug cost savings for payers. Implications are significant for public payers facing increasing financial constraints, as savings can be reallocated to patient care.",2020,"Enrolling patients in clinical trials, whether industry-sponsored or academic, leads to substantial drug cost savings for payers.","['177 patients (65.1%) included in 27 trials', 'phase III hematological oncology clinical trials in a university hospital', 'Enrolling patients in clinical trials, whether industry-sponsored or academic, leads to substantial drug cost savings for payers', 'patients with hematological malignancies included from 2011 to 2016 in a phase III trial and having received at least one sponsor-provided cycle', '345 patients included in eligible trials during study period, 272 received sponsor-provided drugs']",[],"['Total cost savings', 'Mean cost saving', 'Drug cost savings', 'cost savings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0085123', 'cui_str': 'Drug Costs'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085123', 'cui_str': 'Drug Costs'}, {'cui': 'C0036245', 'cui_str': 'Savings'}]",,0.0275743,"Enrolling patients in clinical trials, whether industry-sponsored or academic, leads to substantial drug cost savings for payers.","[{'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Herledan', 'Affiliation': 'Clinical Oncology Pharmacy Department, Hospices Civils de Lyon, Groupement Hospitalier Sud, Pierre-Bénite, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Ranchon', 'Affiliation': 'Clinical Oncology Pharmacy Department, Hospices Civils de Lyon, Groupement Hospitalier Sud, Pierre-Bénite, France.'}, {'ForeName': 'Vérane', 'Initials': 'V', 'LastName': 'Schwiertz', 'Affiliation': 'Clinical Oncology Pharmacy Department, Hospices Civils de Lyon, Groupement Hospitalier Sud, Pierre-Bénite, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Baudouin', 'Affiliation': 'Clinical Oncology Pharmacy Department, Hospices Civils de Lyon, Groupement Hospitalier Sud, Pierre-Bénite, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Karlin', 'Affiliation': 'Department of Hematology, Groupement Hospitalier Sud, Hospices Civils de Lyon, Pierre-Bénite, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Ghesquières', 'Affiliation': 'Department of Hematology, Groupement Hospitalier Sud, Hospices Civils de Lyon, Pierre-Bénite, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Salles', 'Affiliation': 'Department of Hematology, Groupement Hospitalier Sud, Hospices Civils de Lyon, Pierre-Bénite, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Rioufol', 'Affiliation': 'Clinical Oncology Pharmacy Department, Hospices Civils de Lyon, Groupement Hospitalier Sud, Pierre-Bénite, France.'}]",Hematological oncology,['10.1002/hon.2753']
1748,33141785,Single-Session Dance/Movement Therapy for Thought and Behavioral Dysfunction Associated With Schizophrenia: A Mixed Methods Feasibility Study.,"This purposes of this mixed methods feasibility study were to determine whether people with schizophrenia in an inpatient psychiatric facility were able to complete the research protocol, and to obtain preliminary treatment effects of a single-session dance/movement therapy (DMT) intervention versus verbal treatment as usual (TAU). Thirty-two participants were randomized to a 45-minute DMT or verbal TAU session. Data were collected quantitatively using the Brief Psychiatric Rating Scale (BPRS) and qualitatively through open-ended interviews. Results indicated that participants in the DMT group had statistically significant symptom reduction compared with those in the TAU group in overall BPRS scores (effect size [ES] = 0.67), psychological discomfort (ES = 0.64), negative symptoms (ES = 0.67), and positive symptoms (ES = 0.55). No statistical significance was shown for resistance. Qualitative findings substantiate the quantitative findings, however, show divergence regarding resistance. Participants in the DMT group expressed feeling in control, less angry, and motivated for treatment.",2020,"Results indicated that participants in the DMT group had statistically significant symptom reduction compared with those in the TAU group in overall BPRS scores (effect size [ES] = 0.67), psychological discomfort (ES = 0.64), negative symptoms (ES = 0.67), and positive symptoms (ES = 0.55).","['people with schizophrenia in an inpatient psychiatric facility', 'Schizophrenia']","['single-session dance/movement therapy (DMT) intervention versus verbal treatment as usual (TAU', 'Single-Session Dance/Movement Therapy', '45-minute DMT or verbal TAU session', 'DMT', 'TAU']","['psychological discomfort', 'Brief Psychiatric Rating Scale (BPRS', 'overall BPRS scores', 'symptom reduction', 'negative symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",32.0,0.0627788,"Results indicated that participants in the DMT group had statistically significant symptom reduction compared with those in the TAU group in overall BPRS scores (effect size [ES] = 0.67), psychological discomfort (ES = 0.64), negative symptoms (ES = 0.67), and positive symptoms (ES = 0.55).","[{'ForeName': 'Jacelyn', 'Initials': 'J', 'LastName': 'Biondo', 'Affiliation': 'Department of Creative Arts Therapies, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Gerber', 'Affiliation': 'Art Therapy Program, Department of Education, Florida State University, Tallahassee, Florida.'}, {'ForeName': 'Joke', 'Initials': 'J', 'LastName': 'Bradt', 'Affiliation': 'Department of Creative Arts Therapies, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': 'Department of Psychiatry, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Goodill', 'Affiliation': 'Department of Creative Arts Therapies, Drexel University, Philadelphia, Pennsylvania.'}]",The Journal of nervous and mental disease,['10.1097/NMD.0000000000001263']
1749,33137174,Do contact precautions reduce the incidence of ICU-acquired Pseudomonas aeruginosa infections? The DPCPYO cluster-randomized crossover trial.,"BACKGROUND
Issue of contact precautions as contributory factors for reducing P. aeruginosa (Pa) infections in intensive care units (ICUs) remains questioned. We evaluated the impact of the addition of contact precautions to standard precautions for Pa-positive patients on the incidence of ICU-acquired Pa infections.
METHODS
In this multicenter cluster-randomized crossover trial, 10 French ICUs were randomly assigned (1:1) to sequence 0-1 (6-month control period [CP]/3-month washout period/6-month intervention period [IP]) or sequence 1-0 (6-month IP/3-month washout period/6-month CP). A surveillance screening program for Pa was implemented. Competing-risks regression models were built with death and discharge without the occurrence of ICU-acquired Pa infection (the primary outcome), as competing events. Models were adjusted for within-ICU correlation, patient- and ICU-level covariates. The Simpson diversity index (SDI) and the transmission index (TI) of Pa isolates were derived from pulsed-field gel electrophoresis typing.
RESULTS
Within recruited ICUs, the cumulative incidence and the incidence rate of ICU-acquired Pa infections were 3.38% (55/1625) vs 3.44% (57/1658) and 3.31 vs 3.52 per 1 000 patient-days at risk during CP and IP, respectively. Multivariable models indicated that the intervention did not significantly change the cumulative incidence (subdistribution hazard ratio 0.91, 95% confidence interval [CI] 0.49-1.67, p=0.76) and the rate (cause-specific hazard ratio 1.36, 95%CI 0.71-2.63, p=0.36) of the primary outcome. SDI and TI did not significantly differ between CP and IP.
CONCLUSIONS
The addition of contact precautions to standard precautions for Pa-positive patients with a surveillance screening program does not significantly reduce ICU-acquired Pa infections in non-outbreak situations.",2020,"Multivariable models indicated that the intervention did not significantly change the cumulative incidence (subdistribution hazard ratio 0.91, 95% confidence interval [CI] 0.49-1.67, p=0.76) and the rate (cause-specific hazard ratio 1.36, 95%CI 0.71-2.63, p=0.36) of the primary outcome.","['10 French ICUs', 'Pa-positive patients on the incidence of ICU-acquired Pa infections']",['sequence 0-1 (6-month control period [CP]/3-month washout period/6-month intervention period [IP]) or sequence 1-0 (6-month IP/3-month washout period/6-month CP'],"['SDI and TI', 'cumulative incidence', 'ICU-acquired Pa infections', 'Simpson diversity index (SDI) and the transmission index (TI) of Pa isolates', 'cumulative incidence and the incidence rate of ICU-acquired Pa infections']","[{'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}]",,0.112108,"Multivariable models indicated that the intervention did not significantly change the cumulative incidence (subdistribution hazard ratio 0.91, 95% confidence interval [CI] 0.49-1.67, p=0.76) and the rate (cause-specific hazard ratio 1.36, 95%CI 0.71-2.63, p=0.36) of the primary outcome.","[{'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Slekovec', 'Affiliation': 'Infection Control Department, Univ. Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Robert', 'Affiliation': ""Centre d'immunologie et des maladies infectieuses-Paris, Cimi-Paris, INSERM, Laboratoire de Bactériologie-Hygiène, AP-HP, Hôpitaux Universitaires Pitié-Salpêtrière - Charles Foix, Sorbonne Université, Paris, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Berthelot', 'Affiliation': 'Hygiène hospitalière et maladies infectieuses, Centre Hospitalier Universitaire, Saint-Etienne, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'van der Mee-Marquet', 'Affiliation': 'Service de Bactériologie, Virologie et Hygiène, Centre Hospitalier Régional Universitaire, Tours, France.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Rogues', 'Affiliation': 'Hygiène hospitalière, Centre Hospitalier Universitaire, INSERM U657, Université de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Derouin', 'Affiliation': 'Bactériologie-Hygiène, AP-HP, Hôpitaux Universitaires Paris Sud-Clamart, Le Kremlin-Bicêtre France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Cholley', 'Affiliation': 'Infection Control Department, Univ. Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Bertrand', 'Affiliation': 'Infection Control Department, Univ. Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Houssein', 'Initials': 'H', 'LastName': 'Gbaguidi-Haore', 'Affiliation': 'Infection Control Department, Univ. Hospital of Besançon, Besançon, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1663']
1750,33137293,"Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials.","BACKGROUND
The melanocortin 4 receptor (MC4R), a component of the leptin-melanocortin pathway, plays a part in bodyweight regulation. Severe early-onset obesity can be caused by biallelic variants in genes that affect the MC4R pathway. We report the results from trials of the MC4R agonist setmelanotide in individuals with severe obesity due to either pro-opiomelanocortin (POMC) deficiency obesity or leptin receptor (LEPR) deficiency obesity.
METHODS
These single-arm, open-label, multicentre, phase 3 trials were done in ten hospitals across Canada, the USA, Belgium, France, Germany, the Netherlands, and the UK. Participants aged 6 years or older with POMC or LEPR deficiency obesity received open-label setmelanotide for 12 weeks. Participants with at least 5 kg weight loss (or ≥5% if weighing <100 kg at baseline) entered an 8-week placebo-controlled withdrawal sequence (including 4 weeks each of blinded setmelanotide and placebo treatment) followed by 32 additional weeks of open-label treatment. The primary endpoint, which was assessed in participants who received at least one dose of study medication and had a baseline assessment (full analysis set), was the proportion of participants with at least 10% weight loss compared with baseline at approximately 1 year. A key secondary endpoint was mean percentage change in the most hunger score of the 11-point Likert-type scale at approximately 1 year on the therapeutic dose, which was assessed in a subset of participants aged 12 years or older in the full analysis set who demonstrated at least 5 kg weight loss (or ≥5% in paediatric participants if baseline bodyweight was <100 kg) over the 12-week open-label treatment phase and subsequently proceeded into the placebo-controlled withdrawal sequence, regardless of later disposition. These studies are registered with ClinicalTrials.gov, NCT02896192 and NCT03287960.
FINDINGS
Between Feb 14, 2017, and Sept 7, 2018, ten participants were enrolled in the POMC trial and 11 participants were enrolled in the LEPR trial, and included in the full analysis and safety sets. Eight (80%) participants in the POMC trial and five (45%) participants in the LEPR trial achieved at least 10% weight loss at approximately 1 year. The mean percentage change in the most hunger score was -27·1% (n=7; 90% CI -40·6 to -15·0; p=0·0005) in the POMC trial and -43·7% (n=7; -54·8 to -29·1; p<0·0001) in the LEPR trial. The most common adverse events were injection site reaction and hyperpigmentation, which were reported in all ten participants in the POMC trial; nausea was reported in five participants and vomiting in three participants. In the LEPR trial, the most commonly reported treatment-related adverse events were injection site reaction in all 11 participants, skin disorders in five participants, and nausea in four participants. No serious treatment-related adverse events occurred in both trials.
INTERPRETATION
Our results support setmelanotide for the treatment of obesity and hyperphagia caused by POMC or LEPR deficiency.
FUNDING
Rhythm Pharmaceuticals.",2020,n=7; 90% CI -40·6 to -15·0; p=0·0005) in the POMC trial and -43·7% (,"['Between Feb 14, 2017, and Sept 7, 2018', 'individuals with severe obesity due to LEPR or POMC deficiency', ' ten participants were enrolled in the POMC trial and 11 participants were enrolled in the LEPR trial, and included in the full analysis and safety sets', 'individuals with severe obesity due to either pro-opiomelanocortin (POMC) deficiency obesity or leptin receptor (LEPR) deficiency obesity', 'Participants aged 6 years or older with POMC or LEPR deficiency obesity received', 'Participants with at least 5 kg weight loss (or ≥5% if weighing <100 kg at baseline) entered an 8-week']","['setmelanotide', 'open-label setmelanotide', 'placebo-controlled withdrawal sequence', 'MC4R agonist setmelanotide']","['weight loss', 'Severe early-onset obesity', 'adverse events', 'nausea', 'vomiting', 'hunger score of the 11-point Likert-type scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0385463', 'cui_str': 'Receptor, Leptin'}, {'cui': 'C0033195', 'cui_str': 'Pro-opiomelanocortin'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0527721', 'cui_str': 'MC4R protein, human'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",10.0,0.273751,n=7; 90% CI -40·6 to -15·0; p=0·0005) in the POMC trial and -43·7% (,"[{'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Clément', 'Affiliation': 'Assistance Publique Hôpitaux de Paris, Nutrition Department, Pitié-Salpêtrière Hospital, Paris, France; Sorbonne Université, INSERM, NutriOmics Research Unit, Paris, France.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'van den Akker', 'Affiliation': ""Division of Pediatric Endocrinology, Department of Pediatrics, Sophia Children's Hospital and Obesity Center CGG, Erasmus University Medical Center, Rotterdam, Netherlands.""}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Argente', 'Affiliation': 'Department of Pediatrics and Pediatric Endocrinology, Universidad Autónoma de Madrid, University Hospital Niño Jesús, CIBER ""Fisiopatología de la obesidad y nutrición"" (CIBEROBN), Instituto de Salud Carlos III, IMDEA Institute, Madrid, Spain.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Bahm', 'Affiliation': 'Peel Memorial Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Wendy K', 'Initials': 'WK', 'LastName': 'Chung', 'Affiliation': 'Department of Pediatrics and Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Hillori', 'Initials': 'H', 'LastName': 'Connors', 'Affiliation': 'Rhythm Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'De Waele', 'Affiliation': 'Department of Pediatric and Adolescent Endocrinology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'I Sadaf', 'Initials': 'IS', 'LastName': 'Farooqi', 'Affiliation': 'Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Gonneau-Lejeune', 'Affiliation': 'Université de la Réunion, Unité Transversale de Nutrition Clinique, CHU de la Réunion, Réunion, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Gordon', 'Affiliation': 'Rhythm Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Kohlsdorf', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Center for Rare Endocrine Diseases, Department of Pediatrics and Adolescent Medicine, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Poitou', 'Affiliation': 'Assistance Publique Hôpitaux de Paris, Nutrition Department, Pitié-Salpêtrière Hospital, Paris, France; Sorbonne Université, INSERM, NutriOmics Research Unit, Paris, France.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Puder', 'Affiliation': 'Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; Department for Pediatric Endocrinology and Diabetology, Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Swain', 'Affiliation': 'HonorHealth Bariatric Center, Scottsdale, AZ, USA.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Stewart', 'Affiliation': 'Rhythm Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Guojun', 'Initials': 'G', 'LastName': 'Yuan', 'Affiliation': 'Rhythm Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wabitsch', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Center for Rare Endocrine Diseases, Department of Pediatrics and Adolescent Medicine, University of Ulm, Ulm, Germany. Electronic address: martin.wabitsch@uniklinik-ulm.de.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kühnen', 'Affiliation': 'Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany. Electronic address: peter.kuehnen@charite.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30364-8']
1751,33137340,"EOS789, a broad-spectrum inhibitor of phosphate transport, is safe with an indication of efficacy in a Phase 1b randomized cross-over trial in hemodialysis patients.","The treatment of hyperphosphatemia remains challenging in patients receiving hemodialysis. This Phase 1b study assessed safety and efficacy of EOS789, a novel pan-inhibitor of phosphate transport (NaPi-2b, PiT-1, PiT-2) on intestinal phosphate absorption in patients receiving intermittent hemodialysis therapy. Two cross-over, randomized order studies of identical design (ten patients each) compared daily EOS789 50 mg to placebo with meals and daily EOS789 100 mg vs EOS789 100 mg plus 1600 mg sevelamer with meals. Patients ate a controlled diet of 900 mg phosphate daily for two weeks and began EOS789 on day four. On day ten, a phosphate absorption testing protocol was performed during the intradialytic period. Intestinal fractional phosphate absorption was determined by kinetic modeling of serum data following oral and intravenous doses of 33 Phosphate ( 33 P). The results demonstrated no study drug related serious adverse events. Fractional phosphate absorption was 0.53 (95% confidence interval: 0.39,0.67) for placebo vs. 0.49 (0.35,0.63) for 50 mg EOS789; and 0.40 (0.29,0.50) for 100 mg EOS789 vs. 0.36 (0.26,0.47) for 100 mg EOS789 plus 1600 mg sevelamer (all not significantly different). The fractional phosphate absorption trended lower in six patients who completed both studies with EOS789 100 mg compared with placebo. Thus, in this Phase 1b study, EOS789 was safe and well tolerated. Importantly, the use of 33 P as a sensitive and direct measure of intestinal phosphate absorption allows specific testing of drug efficacy. The effectiveness of EOS789 needs to be evaluated in future Phase 2 and Phase 3 studies.",2020,"Fractional phosphate absorption was 0.53 (95% confidence interval: 0.39,0.67) for placebo vs. 0.49 (0.35,0.63) for 50 mg EOS789; and 0.40 (0.29,0.50) for 100 mg EOS789 vs. 0.36 (0.26,0.47) for 100 mg EOS789 plus 1600 mg sevelamer (all not significantly different).","['patients receiving hemodialysis', 'patients receiving intermittent hemodialysis therapy', 'hemodialysis patients']","['EOS789', 'placebo', 'EOS789 50 mg to placebo with meals and daily EOS789 100 mg vs EOS789 100 mg plus 1600 mg sevelamer with meals', 'EOS789, a novel pan-inhibitor of phosphate transport (NaPi-2b, PiT-1, PiT-2']","['safe and well tolerated', 'Fractional phosphate absorption', 'Intestinal fractional phosphate absorption', 'fractional phosphate absorption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0472676', 'cui_str': 'Intermittent hemodialysis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4553624', 'cui_str': 'With meals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C0718050', 'cui_str': 'sevelamer'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C1529328', 'cui_str': 'SLC34A2 protein, human'}, {'cui': 'C0175697', 'cui_str': 'Van der Woude syndrome'}]","[{'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}]",,0.0560639,"Fractional phosphate absorption was 0.53 (95% confidence interval: 0.39,0.67) for placebo vs. 0.49 (0.35,0.63) for 50 mg EOS789; and 0.40 (0.29,0.50) for 100 mg EOS789 vs. 0.36 (0.26,0.47) for 100 mg EOS789 plus 1600 mg sevelamer (all not significantly different).","[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Hill Gallant', 'Affiliation': 'Purdue University Department of Nutrition Science, West Lafayette, IN; Indiana University School of Medicine, Department of Medicine, Division of Nephrology, Indianapolis, IN.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Stremke', 'Affiliation': 'Purdue University Department of Nutrition Science, West Lafayette, IN.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Trevino', 'Affiliation': 'Indiana University School of Medicine, Clinical Translational Sciences Institute, Indianapolis, IN.'}, {'ForeName': 'Ranjani N', 'Initials': 'RN', 'LastName': 'Moorthi', 'Affiliation': 'Indiana University School of Medicine, Department of Medicine, Division of Nephrology, Indianapolis, IN.'}, {'ForeName': 'Simit', 'Initials': 'S', 'LastName': 'Doshi', 'Affiliation': 'Indiana University School of Medicine, Department of Medicine, Division of Nephrology, Indianapolis, IN.'}, {'ForeName': 'Meryl E', 'Initials': 'ME', 'LastName': 'Wastney', 'Affiliation': 'Purdue University Department of Nutrition Science, West Lafayette, IN; Metabolic Modeling Services, West Lafayette, IN.'}, {'ForeName': 'Nozomi', 'Initials': 'N', 'LastName': 'Hisada', 'Affiliation': 'Chugai Pharmaceutical Co., Ltd.; Tokyo, Japan.'}, {'ForeName': 'Jotaro', 'Initials': 'J', 'LastName': 'Sato', 'Affiliation': 'Chugai Pharmaceutical Co., Ltd.; Tokyo, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Ogita', 'Affiliation': 'Chugai Pharmaceutical Co., Ltd.; Tokyo, Japan.'}, {'ForeName': 'Naohisa', 'Initials': 'N', 'LastName': 'Fujii', 'Affiliation': 'Chugai Pharmaceutical Co., Ltd.; Tokyo, Japan.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Chugai Pharmaceutical Co., Ltd.; Tokyo, Japan.'}, {'ForeName': 'Takei', 'Initials': 'T', 'LastName': 'Kake', 'Affiliation': 'Chugai Pharmaceutical Co., Ltd.; Tokyo, Japan.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Moe', 'Affiliation': 'Indiana University School of Medicine, Department of Medicine, Division of Nephrology, Indianapolis, IN.'}]",Kidney international,['10.1016/j.kint.2020.09.035']
1752,33137352,The relationship between exercise intensity and neurophysiological responses to food stimuli in women: A randomized crossover event-related potential (ERP) study.,"We tested the effect of different intensities of acute exercise on hunger, and post-exercise energy intake, and neurophysiological measures of attention towards food- and non-food stimuli in women. In a within-subjects crossover design, forty-two women completed no exercise, moderate-intensity exercise, and vigorous-intensity exercise sessions separated by one week, in a counterbalanced fashion. At each session, participants completed a passive viewing task of food (high- and low-calorie) and non-food pictures while electroencephalogram (EEG) data were recorded. The early posterior negativity (EPN), P3, and late positive potential (LPP) components of the event-related potential (ERP) measured neurophysiological responses. Subjective ratings of hunger were measured before and immediately after each condition using a visual analog scale (VAS) and food intake was measured using an ad libitum snack buffet offered at the end of each condition. Results indicated that hunger levels increased as time passed for all sessions. EPN amplitude was larger to non-food compared to food images; P3 amplitude was larger to food than non-food stimuli. LPP amplitude did not differ by high-calorie, low-calorie, or non-food images. Notably, there were no significant main effects or interactions of any ERP component amplitude as a function of exercise intensity. Food intake also did not differ by rest or moderate or vigorous exercise, although subjective arousal ratings to the images were higher after moderate and vigorous exercise compared to rest. Food images also had higher arousal and valence ratings than non-food images overall. Findings indicate that, in this sample, acute moderate and vigorous exercise compared to rest did not disproportionately affect neurophysiological measures of attention to food or non-food stimuli, caloric intake, or hunger.",2020,EPN amplitude was larger to non-food compared to food images; P3 amplitude was larger to food than non-food items.,['women'],['passive viewing task of food (high- and low-calorie) and non-food pictures while electroencephalogram (EEG'],"['neurophysiological measures of attention to food or non-food stimuli, caloric intake, or hunger', 'higher arousal and valence ratings', 'early posterior negativity (EPN), P3, and late positive potential (LPP) components of the event-related potential (ERP) measured neurophysiological responses', 'LPP amplitude', 'subjective arousal ratings', 'visual analog scale (VAS) and food intake', 'Subjective ratings of hunger', 'EPN amplitude', 'hunger levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0014614', 'cui_str': 'Ethyl nitrophenyl benzene thiophosphonate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",42.0,0.0752239,EPN amplitude was larger to non-food compared to food images; P3 amplitude was larger to food than non-food items.,"[{'ForeName': 'Kaylie A', 'Initials': 'KA', 'LastName': 'Carbine', 'Affiliation': 'Department of Psychology, California State University Dominguez Hills, United States of America.'}, {'ForeName': 'Jillesa', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, United States of America.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Larson', 'Affiliation': 'Department of Psychology, Brigham Young University, United States of America; Neuroscience Center, Brigham Young University, United States of America.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'LeCheminant', 'Affiliation': 'Department of Nutrition, Dietetics, and Food Science, Brigham Young University, United States of America.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Bailey', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, United States of America. Electronic address: bruce_bailey@byu.edu.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.10.011']
1753,33137378,Pioglitazone corrects dysregulation of skeletal muscle mitochondrial proteins involved in ATP synthesis in type 2 diabetes.,"Context In this study, we aimed to identify the determinants of mitochondrial dysfunction in skeletal muscle (SKLM) of subjects with type 2 diabetes (T2DM), and to evaluate the effect of pioglitazone (PIO) on SKLM mitochondrial proteome.
METHODS
Two different groups of adults were studied. Group I consisted of 8 individuals with normal glucose tolerance (NGT) and 8 with T2DM, subjected to SKLM mitochondrial proteome analysis by 2D-gel electrophoresis followed by mass spectrometry-based protein identification. Group II included 24 individuals with NGT and 24 with T2DM, whose SKLM biopsies were subjected to immunoblot analysis. Of the 24 subjects with T2DM, 20 were randomized to receive placebo or PIO (15 mg daily) for 6 months. After 6 months of treatment, SKLM biopsy was repeated.
RESULTS
Mitochondrial proteomic analysis on Group I revealed that several mitochondrial proteins involved in oxidative metabolism were differentially expressed between T2DM and NGT groups, with a downregulation of ATP synthase alpha chain (ATP5A), electron transfer flavoprotein alpha-subunit (ETFA), cytochrome c oxidase subunit VIb isoform 1 (CX6B1), pyruvate dehydrogenase protein X component (ODPX), dihydrolipoamide dehydrogenase (DLDH), dihydrolipoamide-S-succinyltransferase (DLST), and mitofilin, and an up-regulation of hydroxyacyl-CoA-dehydrogenase (HCDH), 3,2-trans-enoyl-CoA-isomerase (D3D2) and delta3,5-delta2,4-dienoyl-CoA-isomerase (ECH1) in T2DM as compared to NGT subjects. By immunoblot analysis on SKLM lysates obtained from Group II we confirmed that, in comparison to NGT subjects, those with T2DM exhibited lower protein levels of ATP5A (-30%, P=0.006), ETFA (-50%, P=0.02), CX6B1 (-30%, P=0.03), key factors for ATP biosynthesis, and of the structural protein mitofilin (-30%, P=0.01). T2DM was associated with a reduced abundance of the enzymes involved in the Krebs cycle DLST and ODPX (-20%, P≤0.05) and increased levels of HCDH and ECH1, enzymes implicated in the fatty acid catabolism (+30%, P≤0.05). In subjects with type 2 diabetes treated with PIO for 6 months we found a restored SKLM protein abundance of ATP5A, ETFA, CX6B1, and mitofilin. Moreover, protein levels of HCDH and ECH1 were reduced by -10% and -15% respectively (P≤0.05 for both) after PIO treatment.
CONCLUSION
Type 2 diabetes is associated with reduced levels of mitochondrial proteins involved in oxidative phosphorylation and an increased abundance of enzymes implicated in fatty acid catabolism in SKLM. PIO treatment is able to improve SKLM mitochondrial proteomic profile in subjects with T2DM.",2020,"T2DM was associated with a reduced abundance of the enzymes involved in the Krebs cycle DLST and ODPX (-20%, P≤0.05) and increased levels of HCDH and ECH1, enzymes implicated in the fatty acid catabolism (+30%, P≤0.05).","['subjects with type 2 diabetes (T2DM', 'Group II included 24 individuals with NGT and 24 with T2DM, whose SKLM biopsies', '24 subjects with T2DM, 20', 'subjects with T2DM']","['pioglitazone (PIO', 'Pioglitazone', 'normal glucose tolerance (NGT) and 8 with T2DM, subjected to SKLM mitochondrial proteome analysis by 2D-gel electrophoresis followed by mass spectrometry-based protein identification', 'placebo or PIO']","['restored SKLM protein abundance of ATP5A, ETFA, CX6B1, and mitofilin', 'oxidative metabolism', 'ATP synthase alpha chain (ATP5A), electron transfer flavoprotein alpha-subunit (ETFA), cytochrome c oxidase subunit VIb isoform 1 (CX6B1), pyruvate dehydrogenase protein X component (ODPX), dihydrolipoamide dehydrogenase (DLDH), dihydrolipoamide-S-succinyltransferase (DLST), and mitofilin', 'protein levels of ATP5A', 'ETFA', 'levels of HCDH and ECH1, enzymes implicated in the fatty acid catabolism', 'CX6B1', 'protein levels of HCDH and ECH1']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C2315740', 'cui_str': 'Biopsy of skeletal muscle'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0751973', 'cui_str': 'Proteomes'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0013860', 'cui_str': 'Electrophoresis, Gel, Two Dimensional'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0037813', 'cui_str': 'Mass spectrometry measurement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1568849', 'cui_str': 'ETFA protein, human'}, {'cui': 'C0282636', 'cui_str': 'Respiration, Cell'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0132555', 'cui_str': 'Nitric-oxide synthase'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0010760', 'cui_str': 'Cytochrome c oxidase'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C0072792', 'cui_str': 'Pyruvate dehydrogenase (lipoamide)'}, {'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0023783', 'cui_str': 'Dihydrolipoamide dehydrogenase'}, {'cui': 'C0058086', 'cui_str': 'dihydrolipoamide'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0543484', 'cui_str': 'catabolism'}]",8.0,0.039439,"T2DM was associated with a reduced abundance of the enzymes involved in the Krebs cycle DLST and ODPX (-20%, P≤0.05) and increased levels of HCDH and ECH1, enzymes implicated in the fatty acid catabolism (+30%, P≤0.05).","[{'ForeName': 'Teresa Vanessa', 'Initials': 'TV', 'LastName': 'Fiorentino', 'Affiliation': 'Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy; Division of Diabetes, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Monroy', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Oncology, General Hospital of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Subash', 'Initials': 'S', 'LastName': 'Kamath', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Sotero', 'Affiliation': 'Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Michele Dei', 'Initials': 'MD', 'LastName': 'Cas', 'Affiliation': 'Clinical Biochemistry and Mass Spectrometry Laboratory, Department of Health Science, University of Milan, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Daniele', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Alberto O', 'Initials': 'AO', 'LastName': 'Chavez', 'Affiliation': 'Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Marta Letizia', 'Initials': 'ML', 'LastName': 'Hribal', 'Affiliation': 'Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Sesti', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome-Sapienza, Rome, Italy.'}, {'ForeName': 'Devjit', 'Initials': 'D', 'LastName': 'Tripathy', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Ralph A', 'Initials': 'RA', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Folli', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Endocrinology and Metabolism, Department of Health Science, University of Milan, Milan, Italy. Electronic address: franco.folli@unimi.it.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154416']
1754,33137422,Therapeutic Ultrasound for Chemotherapy-related Pain and Sensory Disturbance in the Hands and Feet in Patients with Colorectal Cancer: A Pilot Randomized Controlled Trial.,"OBJECTIVES
The aim of this study was to determine the feasibility and preliminary efficacy of adding therapeutic ultrasound to a home-based therapeutic exercise program (current standard of care) for patients presenting with oxaliplatin-related pain and sensory disturbance in the hands and feet.
METHODS
Thirty-one colorectal cancer patients with presenting symptoms of peripheral sensory neuropathy, based on a physician rated Grade 1, 2 or 3 on the National Cancer Institute Common Terminology Criteria for Adverse Events for sensory and motor neuropathy, were enrolled in the trial. Patients were randomized to either 10 sessions of ultrasound therapy intervention over two-week period (continuous ultrasound at an intensity of 0.7 to 0.8 w/cm 2 , and frequency of 3 MHz for 5 minutes) plus standard care (N=16) or to standard care alone (N=15). The feasibility of therapeutic ultrasound was determined by the recruitment rate, participants' adherence to the intervention, and the study completion rates. Assessments of pain, sensory disturbance, sensation and balance were conducted at baseline, two and six weeks.
RESULTS
We achieved a recruitment rate of 84%, an adherence rate of 100% to the intervention and a completion rate of 100%. Adding therapeutic ultrasound to standard care resulted in a statistically and clinically significant improvement in symptoms of pain and sensory disturbance (p =0.003) at two weeks; however, no significance difference between the groups was found at the 6-week follow-up.
CONCLUSIONS
The findings of this proof-of-concept study support the feasibility of the therapeutic ultrasound in addition to standard care as an intervention for colorectal cancer patients with oxaliplatin related pain and sensory disturbance in the hands and feet. The findings warrant a large-scale placebo-controlled trial.",2020,"Adding therapeutic ultrasound to standard care resulted in a statistically and clinically significant improvement in symptoms of pain and sensory disturbance (p =0.003) at two weeks; however, no significance difference between the groups was found at the 6-week follow-up.
","['Patients with Colorectal Cancer', 'Thirty-one colorectal cancer patients with presenting symptoms of peripheral sensory neuropathy, based on a physician rated Grade 1, 2 or 3 on the National Cancer Institute Common Terminology Criteria for Adverse Events for sensory and motor neuropathy, were enrolled in the trial', 'patients presenting with oxaliplatin-related pain and sensory disturbance in the hands and feet', 'colorectal cancer patients with']","['therapeutic ultrasound to a home-based therapeutic exercise program (current standard of care', 'ultrasound therapy intervention over two-week period (continuous ultrasound at an intensity of 0.7 to 0.8 w/cm 2 , and frequency of 3 MHz for 5 minutes) plus standard care (N=16) or to standard care alone', 'oxaliplatin']","['symptoms of pain and sensory disturbance', 'adherence rate', 'pain and sensory disturbance', 'pain, sensory disturbance, sensation and balance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0235025', 'cui_str': 'Peripheral motor neuropathy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0152027', 'cui_str': 'Sensory disorder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]","[{'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0556962', 'cui_str': 'MHz'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0152027', 'cui_str': 'Sensory disorder'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",31.0,0.0553866,"Adding therapeutic ultrasound to standard care resulted in a statistically and clinically significant improvement in symptoms of pain and sensory disturbance (p =0.003) at two weeks; however, no significance difference between the groups was found at the 6-week follow-up.
","[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Al Onazi', 'Affiliation': 'Faculty of Rehabilitation Medicine, Department of Physical Therapy, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yurick', 'Affiliation': 'Department of Rehabilitation Medicine, Cross Cancer Institute, Alberta Health Services, Edmonton, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': 'Faculty of Rehabilitation Medicine, Department of Physical Therapy, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nishimura', 'Affiliation': 'Faculty of Rehabilitation Medicine, Department of Physical Therapy, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Suderman', 'Affiliation': 'Faculty of Rehabilitation Medicine, Department of Physical Therapy, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pituskin', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Alberta, Canada; Department of Oncology, Cross Cancer Institute, Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Chua', 'Affiliation': 'Department of Oncology, Cross Cancer Institute, Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'McNeely', 'Affiliation': 'Faculty of Rehabilitation Medicine, Department of Physical Therapy, University of Alberta, Edmonton, Alberta, Canada; Department of Rehabilitation Medicine, Cross Cancer Institute, Alberta Health Services, Edmonton, Canada. Electronic address: mmcneely@ualberta.ca.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.10.028']
1755,33137453,Alveolar recruitment manoeuvre results in improved pulmonary function in obese patients undergoing bariatric surgery: a randomised trial.,"Perioperative ventilation is an important challenge of anaesthesia, especially in obese patients: body mass index is correlated with reduction of the pulmonary volume and they develop significantly more perioperative atelectasis and pulmonary complications. The alveolar recruitment manoeuvre is the most effective technique to reverse atelectasis. However, the clinical benefit on lung function in the perioperative period is not clear. The aim of the present study is to assess the perioperative clinical results of systematic alveolar recruitment manoeuvre associated with protective ventilation in patients undergoing laparoscopic bariatric surgery. It was a single-centre, randomised, double blind, superiority trial: control group with standard protective ventilation and recruitment group with protective ventilation and systematic recruitment manoeuvre. The primary outcome was a composite clinical criterion of pulmonary dysfunction including oxygen saturation, oxygen needs and dyspnoea in recovery room and at day 1. Secondary outcomes were recruitment manoeuvre tolerance, pulmonary and non-pulmonary complications, length of hospital stay and proportion of Intensive Care Unit admission. Two hundred and thirty patients were included: 115 in the recruitment manoeuvre group and 115 in the control group, 2 patients were excluded from the analysis in the control group. Patients in the recruitment manoeuvre group had significantly lower rate of pulmonary dysfunction in the recovery room (73% versus 84% (p = 0.043) and 77% versus 88% at postoperative day 1 (p = 0.043)). No significant differences were found for secondary outcomes. No patient was excluded from the recruitment manoeuvre group for intolerance to the manoeuvre. Recruitment Manoeuvre is safe and effective in reducing early pulmonary dysfunction in obese patients undergoing bariatric surgery.",2020,No significant differences were found for secondary outcomes.,"['Two hundred and thirty patients were included: 115 in the recruitment manoeuvre group and 115 in the control group, 2 patients were excluded from the analysis in the control group', 'obese patients', 'obese patients undergoing bariatric surgery', 'patients undergoing laparoscopic bariatric surgery']","['standard protective ventilation and recruitment group with protective ventilation and systematic recruitment manoeuvre', 'systematic alveolar recruitment manoeuvre associated with protective ventilation', 'Perioperative ventilation']","['composite clinical criterion of pulmonary dysfunction including oxygen saturation, oxygen needs and dyspnoea in recovery room and at day 1', 'manoeuvre tolerance, pulmonary and non-pulmonary complications, length of hospital stay and proportion of Intensive Care Unit admission', 'pulmonary function', 'rate of pulmonary dysfunction']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0303407', 'cui_str': 'Indium-115'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",230.0,0.147389,No significant differences were found for secondary outcomes.,"[{'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Severac', 'Affiliation': ""Department of Anaesthesia, Nice University Hospital, University Côte d'Azur, Nice, France. Electronic address: severac.m@chu-nice.fr.""}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Chiali', 'Affiliation': ""Department of Anaesthesia, Nice University Hospital, University Côte d'Azur, Nice, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Severac', 'Affiliation': 'Department of Biostatistics, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Perus', 'Affiliation': ""Department of Anaesthesia, Nice University Hospital, University Côte d'Azur, Nice, France.""}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Orban', 'Affiliation': ""Department of Anaesthesia, Nice University Hospital, University Côte d'Azur, Nice, France.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Iannelli', 'Affiliation': 'Department of Digestive Surgery and Liver Transplantation, Nice University Hospital, University Côte d\'Azur, Nice, France; Inserm, U1065, Team 8 ""Hepatic complications of obesity"", University Côte d\'Azur, Nice, France.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Debs', 'Affiliation': ""Department of Digestive Surgery and Liver Transplantation, Nice University Hospital, University Côte d'Azur, Nice, France.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gugenheim', 'Affiliation': ""Department of Digestive Surgery and Liver Transplantation, Nice University Hospital, University Côte d'Azur, Nice, France.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Raucoules-Aimé', 'Affiliation': ""Department of Anaesthesia, Nice University Hospital, University Côte d'Azur, Nice, France.""}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.09.011']
1756,33137489,"Exercise mitigates sleep-loss-induced changes in glucose tolerance, mitochondrial function, sarcoplasmic protein synthesis, and diurnal rhythms.","OBJECTIVE
Sleep loss has emerged as a risk factor for the development of impaired glucose tolerance. The mechanisms underpinning this observation are unknown; however, both mitochondrial dysfunction and circadian misalignment have been proposed. Given that exercise improves glucose tolerance, mitochondrial function, and alters circadian rhythms, we investigated whether exercise may counteract the effects induced by inadequate sleep.
METHODS
24 healthy young males were allocated, so as to minimise between-group differences of baseline characteristics, into one of the three experimental groups; a Normal Sleep (NS) group (8 h time in bed (TIB) per night, for five nights), a Sleep Restriction (SR) group (4 h TIB per night, for five nights), and a Sleep Restriction and Exercise group (SR+EX) (4 h TIB per night, for five nights and three high-intensity interval exercise (HIIE) sessions). Glucose tolerance, mitochondrial respiratory function, sarcoplasmic protein synthesis (SarcPS), and diurnal measures of peripheral skin temperature were assessed pre- and post-intervention.
RESULTS
We report that the SR group had reduced glucose tolerance post-intervention (mean change ± SD, P value, SR glucose AUC: 149 ± 115 A.U., P=0.002), which was also associated with reductions in mitochondrial respiratory function (SR: -15.9 ± 12.4 pmol O 2 .s -1 .mg -1 , P=0.001), a lower rate of SarcPS (FSR%/day SR: 1.11 ± 0.25%, P<0.001), and reduced amplitude of diurnal rhythms. These effects were not observed when incorporating three sessions of HIIE during this period (SR+EX: glucose AUC 67 ± 57, P=0.239, mitochondrial respiratory function: 0.6 ± 11.8 pmol O 2 .s -1 .mg -1 , P=0.997, and SarcPS (FSR%/day): 1.77 ± 0.22%, P=0.971).
CONCLUSIONS
A five-night period of sleep restriction leads to reductions in mitochondrial respiratory function, SarcPS, and amplitude of skin temperature diurnal rhythms, with concurrent reductions in glucose tolerance. We provide novel data demonstrating that these same detrimental effects are not observed when HIIE is performed during the period of sleep restriction. These data therefore provide evidence in support of the use of HIIE as an intervention to mitigate the detrimental physiological effects of sleep loss.",2020,"Glucose tolerance, mitochondrial respiratory function, sarcoplasmic protein synthesis (SarcPS), and diurnal measures of peripheral skin temperature were assessed pre- and post-intervention.
",['24 healthy young males'],"['SarcPS', 'Normal Sleep (NS) group (8 h time in bed (TIB) per night, for five nights), a Sleep Restriction (SR) group (4 h TIB per night, for five nights), and a Sleep Restriction and Exercise group (SR+EX) (4 h TIB per night, for five nights and three high-intensity interval exercise (HIIE) sessions']","['lower rate of SarcPS', 'Exercise mitigates sleep-loss-induced changes in glucose tolerance, mitochondrial function, sarcoplasmic protein synthesis, and diurnal rhythms', 'reduced glucose tolerance', 'Glucose tolerance, mitochondrial respiratory function, sarcoplasmic protein synthesis (SarcPS), and diurnal measures of peripheral skin temperature', 'amplitude of diurnal rhythms', 'glucose tolerance, mitochondrial function, and alters circadian rhythms', 'mitochondrial respiratory function, SarcPS, and amplitude of skin temperature diurnal rhythms', 'glucose tolerance', 'mitochondrial respiratory function']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0235161', 'cui_str': 'Sleep loss'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}]",24.0,0.0375417,"Glucose tolerance, mitochondrial respiratory function, sarcoplasmic protein synthesis (SarcPS), and diurnal measures of peripheral skin temperature were assessed pre- and post-intervention.
","[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Saner', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia; Sports Cardiology, Baker Heart and Diabetes Institute, Melbourne, Australia. Electronic address: nicholas.saner@live.vu.edu.au.'}, {'ForeName': 'Matthew J-C', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Jujiao', 'Initials': 'J', 'LastName': 'Kuang', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Nathan W', 'Initials': 'NW', 'LastName': 'Pitchford', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia; Sport Performance Optimisation Research Team, School of Human Life Sciences, University of Tasmania, Launceston, Australia.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Roach', 'Affiliation': 'Appleton Institute for Behavioural Science, Central Queensland University, Adelaide, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Garnham', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Genders', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Tanner', 'Initials': 'T', 'LastName': 'Stokes', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Schroder', 'Affiliation': 'Department of Physiology, College of Medicine, University of Kentucky, Lexington, United States.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Huo', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Karyn A', 'Initials': 'KA', 'LastName': 'Esser', 'Affiliation': 'Department of Physiology and Functional Genomics, University of Florida, Gainesville, United States.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bishop', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia. Electronic address: david.bishop@vu.edu.au.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Bartlett', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}]",Molecular metabolism,['10.1016/j.molmet.2020.101110']
1757,33137591,How to improve social communication in aging: Pragmatic and cognitive interventions.,"Among all aspects of the linguistic and communicative competence, pragmatics seems especially vulnerable in aging, due also to cognitive decline. However, pragmatics has never been considered as an intervention target in healthy aging. Here we tested the effects of a novel training program to improve pragmatics (PragmaCom) in older adults, compared with an active cognitive control group in a randomized-controlled-trial design. Both the PragmaCom group and the control group improved in pragmatic skills such as understanding metaphors and avoiding off-topic speech, indicating that it is possible to improve pragmatics in aging both with a specific training and with a cognitive training. Individual cognitive factors predicted pragmatic improvement in the control group, while in the PragmaCom group benefits were less dependent on individual characteristics. We discuss the results in terms of pragmatic plasticity, highlighting the importance of these findings for promoting older adults' social communication and well-being.",2020,"Both the PragmaCom group and the control group improved in pragmatic skills such as understanding metaphors and avoiding off-topic speech, indicating that it is possible to improve pragmatics in aging both with a specific training and with a cognitive training.",['older adults'],['novel training program to improve pragmatics (PragmaCom'],['pragmatic skills such as understanding metaphors and avoiding off-topic speech'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]","[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0302829', 'cui_str': 'Metaphor'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]",,0.0229649,"Both the PragmaCom group and the control group improved in pragmatic skills such as understanding metaphors and avoiding off-topic speech, indicating that it is possible to improve pragmatics in aging both with a specific training and with a cognitive training.","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Bambini', 'Affiliation': 'Center for Neurocognition, Epistemology and Theoretical Syntax (NEtS), University School for Advanced Studies IUSS Pavia, Piazza della Vittoria 15, 27100 Pavia, Italy. Electronic address: valentina.bambini@iusspavia.it.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Tonini', 'Affiliation': 'Center for Neurocognition, Epistemology and Theoretical Syntax (NEtS), University School for Advanced Studies IUSS Pavia, Piazza della Vittoria 15, 27100 Pavia, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Ceccato', 'Affiliation': ""Department of Neuroscience, Imaging and Clinical Sciences, University G. d'Annunzio of Chieti-Pescara, Via Luigi Polacchi 11, 66100 Chieti, Italy.""}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Lecce', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Piazza Botta 11, 27100 Pavia, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Marocchini', 'Affiliation': 'Laboratory of Language and Cognition, University of Genoa, Via Balbi 30, 16128 Genoa, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Cavallini', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Piazza Botta 11, 27100 Pavia, Italy.'}]",Brain and language,['10.1016/j.bandl.2020.104864']
1758,33137599,"Effects of curcumin supplementation on blood glucose, insulin resistance and androgens in patients with polycystic ovary syndrome: A randomized double-blind placebo-controlled clinical trial.","BACKGROUND
Curcumin is a biologically active phytochemical ingredient found in turmeric. It has several pharmacologic effects that might benefit patients with polycystic ovary syndrome (PCOS).
OBJECTIVE
We hypothesized curcumin to be effective in improving blood sugar levels, insulin resistance and hyperandrogenism in individuals with PCOS.
METHODS
In a randomized double-blind placebo-controlled trial, individuals with PCOS were treated with curcumin (500 mg three times daily) or placebo for 12 weeks. Primary outcome measures were fasting plasma glucose (FPG), fasting insulin (FI), sex hormone levels, and hirsutism (Ferriman-Gallwey [mFG] score). Secondary outcomes included anthropometric measurements.
RESULTS
Of 72 randomized individuals, 67 completed the trial. The two groups were comparable at baseline. At the end of the study, FPG and Dehydroepiandrosterone levels had decreased significantly in the intervention group compared to control (difference of change (post-pre) between intervention and placebo groups: -4.11 mg/dL; 95% CI: -8.35, -0.35 mg/dL; p = 0.033 and -26.53 microg/dL; 95% CI: -47.99, -4.34 µg/dL; p = 0.035, respectively). We also observed a statistically non-significant increase (p = 0.082) in Estradiol levels in the intervention group compared to control. No serious adverse events were reported throughout the trial.
CONCLUSIONS
Curcumin might be a safe and useful supplement to ameliorate PCOS-associated hyperandrogenemia and hyperglycemia. However, longer trials investigating different dosages in longer durations are needed to underpin these findings.",2020,"At the end of the study, FPG and Dehydroepiandrosterone levels had decreased significantly in the intervention group compared to control (difference of change (post-pre) between intervention and placebo groups: -4.11 mg/dL; 95% CI: -8.35, -0.35 mg/dL; p = 0.033 and -26.53 microg/dL; 95% CI: -47.99, -4.34 µg/dL; p = 0.035, respectively).","['patients with polycystic ovary syndrome', '72 randomized individuals', 'individuals with PCOS', 'patients with polycystic ovary syndrome (PCOS']","['placebo', 'curcumin supplementation', 'curcumin']","['Estradiol levels', 'fasting plasma glucose (FPG), fasting insulin (FI), sex hormone levels, and hirsutism (Ferriman-Gallwey [mFG] score', 'blood glucose, insulin resistance and androgens', 'blood sugar levels, insulin resistance and hyperandrogenism', 'anthropometric measurements', 'FPG and Dehydroepiandrosterone levels', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019572', 'cui_str': 'Hirsutism'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0206081', 'cui_str': 'Hyperandrogenization syndrome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.755846,"At the end of the study, FPG and Dehydroepiandrosterone levels had decreased significantly in the intervention group compared to control (difference of change (post-pre) between intervention and placebo groups: -4.11 mg/dL; 95% CI: -8.35, -0.35 mg/dL; p = 0.033 and -26.53 microg/dL; 95% CI: -47.99, -4.34 µg/dL; p = 0.035, respectively).","[{'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Heshmati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Moini', 'Affiliation': ""Breast Disease Research Center(BDRC), Tehran University Of Medical Sciences, Tehran, Iran; Department of Obstetrics and Gynecology, Endocrinology and Female Infertility Unit, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran; Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.""}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Sepidarkish', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Morvaridzadeh', 'Affiliation': 'Department of Nutritional Science, School of Nutritional Science and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Andriko', 'Initials': 'A', 'LastName': 'Palmowski', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Maryam Farid', 'Initials': 'MF', 'LastName': 'Mojtahedi', 'Affiliation': ""Department of Obstetrics and Gynecology, Endocrinology and Female Infertility Unit, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: m_fmojtahedi@tums.ac.ir.""}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Shidfar', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: shidfar.f@iums.ac.ir.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153395']
1759,33137600,Comorbid posttraumatic stress disorder and major depressive disorder: The usefulness of a sequential treatment approach within a randomised design.,"Cognitive Processing Therapy (CPT) and Behavioural Activation Therapy (BA) were used to treat individuals with comorbid posttraumatic stress disorder (PTSD) and major depressive disorder (MDD). Fifty-two individuals (48 women, 4 men) were randomized to CPT alone (n = 18), CPT then BA for MDD (n = 17), or BA then CPT (n = 17). Presenting trauma was primarily interpersonal (87 %). Participants were assessed at pre-, posttreatment, and 6-month follow-up. PTSD and MDD symptoms were the main outcome of interest; trauma cognitions, rumination, and emotional numbing were secondary outcomes. All groups showed sizeable reductions in PTSD and depression (effect sizes at follow-up ranging between 1.02-2.54). A pattern of findings indicated CPT/BA showed better outcomes in terms of larger effect sizes and loss of diagnoses relative to CPT alone and BA/CPT. At follow-up greater numbers of the CPT/BA group were estimated to have achieved good end-state for remission of both PTSD and depression (49 %, CI 95 [.26, .73]) relative to CPT alone (18 %, CI 95 [.03, .38]) and BA/CPT (11 %, CI 95 [.01, .29]). Although tempered by the modest sample size, the findings suggest that individuals with comorbid PTSD and MDD may benefit from having PTSD targeted first before remaining MDD symptoms are addressed.",2020,All groups showed sizeable reductions in PTSD and depression (effect sizes at follow-up ranging between 1.02-2.54).,"['Fifty-two individuals (48 women, 4 men', 'individuals with comorbid posttraumatic stress disorder (PTSD) and major depressive disorder (MDD', 'Comorbid posttraumatic stress disorder and major depressive disorder']","['CPT alone', 'CPT', 'Cognitive Processing Therapy (CPT) and Behavioural Activation Therapy (BA']","['PTSD and depression (effect sizes', 'interest; trauma cognitions, rumination, and emotional numbing', 'PTSD and MDD symptoms']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0666769,All groups showed sizeable reductions in PTSD and depression (effect sizes at follow-up ranging between 1.02-2.54).,"[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Angelakis', 'Affiliation': 'School of Psychology, Flinders University, GPO Box 2100, Adelaide, SA 5001, Australia. Electronic address: samantha.angelakis@flinders.edu.au.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Weber', 'Affiliation': 'School of Psychology, Flinders University, GPO Box 2100, Adelaide, SA 5001, Australia. Electronic address: nathan.weber@flinders.edu.au.'}, {'ForeName': 'Reginald D V', 'Initials': 'RDV', 'LastName': 'Nixon', 'Affiliation': 'School of Psychology, Flinders University, GPO Box 2100, Adelaide, SA 5001, Australia. Electronic address: reg.nixon@flinders.edu.au.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102324']
1760,33137602,"But first, coffee: The roles of arousal and inhibition in the resistance of compulsive cleansing in individuals with high contamination fears.","Inhibition plays a crucial role in reducing intrusive thoughts and compulsive behaviors, such as handwashing, in response to the feeling of disgust. The current study examines whether manipulating arousal can facilitate inhibition and the resistance of compulsive cleansing. Forty-seven participants with high contamination fears were recruited for this study. Participants were divided into a caffeine group or a no-caffeine group. Participants touched a potentially contaminated and disgusting stimulus (""dirty"" diapers) and were asked to wait as long as they could before washing their hands. Only the caffeine group exhibited greater pre-post stop-signal reaction time improvement in the stop-signal task, indicating improved inhibition. Participants in the caffeine group exhibited significantly lower subjective distress and urges-to-wash their hands both after touching the stimulus and while waiting to engage in the cleansing behavior. Similarly, the caffeine group resisted the urge to compulsively cleanse for about twice as long as those in the no-caffeine group. Time spent washing, subjective distress levels, and urge-to-wash levels after participants washed their hands were similar between groups. The current findings support the notion that increased arousal improves inhibition, which may play a role in improving our ability to resist intrusive disgust and compulsive cleansing behaviors.",2020,Participants in the caffeine group exhibited significantly lower subjective distress and urges-to-wash their hands both after touching the stimulus and while waiting to engage in the cleansing behavior.,"['individuals with high contamination fears', 'Forty-seven participants with high contamination fears']","['caffeine', 'caffeine group or a no-caffeine']","['subjective distress', 'urge to compulsively cleanse', 'Time spent washing, subjective distress levels, and urge-to-wash levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1547959', 'cui_str': 'Wash'}]",47.0,0.0193422,Participants in the caffeine group exhibited significantly lower subjective distress and urges-to-wash their hands both after touching the stimulus and while waiting to engage in the cleansing behavior.,"[{'ForeName': 'Hadar', 'Initials': 'H', 'LastName': 'Naftalovich', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel, Jerusalem, Israel. Electronic address: Hadar.naftalovich@mail.huji.ac.il.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Tauber', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel, Jerusalem, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Kalanthroff', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel, Jerusalem, Israel.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102316']
1761,33137674,Application of carbon nanoparticles combined with intraoperative neuromonitoring in papillary thyroid microcarcinoma surgery.,"PURPOSES
To improve the lymph node dissection as well as protect parathyroid gland and recurrent laryngeal nerve, the carbon nanoparticles and intraoperative neuromonitoring were applied in papillary thyroid microcarcinoma surgery.
METHODS
Carbon nanoparticles and intraoperative neuromonitoring were used in the experimental group, whereas the control group were not. Routine pathological examination was performed.
RESULTS
The lymph nodes dissected was significantly higher in the experimental group, but the metastatic lymph nodes were not. The number of mistakenly dissected parathyroid gland and postoperative hypoparathyroidism were 3 and 13 in the experimental group respectively, significantly less than 10 and 25 in the control group. The incidences of overall, transient and persistent recurrent laryngeal nerve palsy in the experimental group were 5.5%, 5.5% and 0% respectively, whereas in the control group were 8.6%, 6.9% and 1.7%.
CONCLUSIONS
Carbon nanoparticles can improve lymph node dissection in papillary thyroid microcarcinoma surgery, and the combination of carbon nanoparticles with intraoperative neuromonitoring can reduce surgical complications and improve patient quality of life.",2020,"The incidences of overall, transient and persistent recurrent laryngeal nerve palsy in the experimental group were 5.5%, 5.5% and 0% respectively, whereas in the control group were 8.6%, 6.9% and 1.7%.
",['papillary thyroid microcarcinoma surgery'],"['carbon nanoparticles combined with intraoperative neuromonitoring', 'carbon nanoparticles and intraoperative neuromonitoring', 'Carbon nanoparticles']","['number of mistakenly dissected parathyroid gland and postoperative hypoparathyroidism', 'patient quality of life', 'incidences of overall, transient and persistent recurrent laryngeal nerve palsy']","[{'cui': 'C1709457', 'cui_str': 'Papillary Thyroid Microcarcinoma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0030518', 'cui_str': 'Parathyroid structure'}, {'cui': 'C0342341', 'cui_str': 'Post-surgical hypoparathyroidism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0542142', 'cui_str': 'Vagus nerve laryngeal paralysis'}]",,0.0272958,"The incidences of overall, transient and persistent recurrent laryngeal nerve palsy in the experimental group were 5.5%, 5.5% and 0% respectively, whereas in the control group were 8.6%, 6.9% and 1.7%.
","[{'ForeName': 'Taolang', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China. Electronic address: 0078029@sina.com.'}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China. Electronic address: anhuimazhiyuan@163.com.'}, {'ForeName': 'Chengli', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China. Electronic address: 1373793942@qq.com.'}, {'ForeName': 'Renmin', 'Initials': 'R', 'LastName': 'Mu', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China. Electronic address: Mu15820570165@163.com.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China. Electronic address: anyonehoo@163.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China. Electronic address: zmuluoyi666@163.com.'}, {'ForeName': 'Junyuan', 'Initials': 'J', 'LastName': 'Lv', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China. Electronic address: junyuanlv@foxmail.com.'}, {'ForeName': 'Zeyu', 'Initials': 'Z', 'LastName': 'Hou', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China. Electronic address: zeyu199139@hotmail.com.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China. Electronic address: 569989262@qq.com.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China. Electronic address: cxm1688@sina.com.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Gastroenterology Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China. Electronic address: onlyoneliuxuemei@163.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102790']
1762,33141834,"Effects of health literacy, screening, and participant choice on action plans for reducing unhealthy snacking in Australia: A randomised controlled trial.","BACKGROUND
Low health literacy is associated with poorer health outcomes. A key strategy to address health literacy is a universal precautions approach, which recommends using health-literate design for all health interventions, not just those targeting people with low health literacy. This approach has advantages: Health literacy assessment and tailoring are not required. However, action plans may be more effective when tailored by health literacy. This study evaluated the impact of health literacy and action plan type on unhealthy snacking for people who have high BMI or type 2 diabetes (Aim 1) and the most effective method of action plan allocation (Aim 2).
METHODS AND FINDINGS
We performed a 2-stage randomised controlled trial in Australia between 14 February and 6 June 2019. In total, 1,769 participants (mean age: 49.8 years [SD = 11.7]; 56.1% female [n = 992]; mean BMI: 32.9 kg/m2 [SD = 8.7]; 29.6% self-reported type 2 diabetes [n = 523]) were randomised to 1 of 3 allocation methods (random, health literacy screening, or participant selection) and 1 of 2 action plans to reduce unhealthy snacking (standard versus literacy-sensitive). Regression analysis evaluated the impact of health literacy (Newest Vital Sign [NVS]), allocation method, and action plan on reduction in self-reported serves of unhealthy snacks (primary outcome) at 4-week follow-up. Secondary outcomes were perceived extent of unhealthy snacking, difficulty using the plans, habit strength, and action control. Analyses controlled for age, level of education, language spoken at home, diabetes status, baseline habit strength, and baseline self-reported serves of unhealthy snacks. Average NVS score was 3.6 out of 6 (SD = 2.0). Participants reported consuming 25.0 serves of snacks on average per week at baseline (SD = 28.0). Regarding Aim 1, 398 participants in the random allocation arm completed follow-up (67.7%). On average, people scoring 1 SD below the mean for health literacy consumed 10.0 fewer serves per week using the literacy-sensitive action plan compared to the standard action plan (95% CI: 0.05 to 19.5; p = 0.039), whereas those scoring 1 SD above the mean consumed 3.0 fewer serves using the standard action plan compared to the literacy-sensitive action plan (95% CI: -6.3 to 12.2; p = 0.529), although this difference did not reach statistical significance. In addition, we observed a non-significant action plan × health literacy (NVS) interaction (b = -3.25; 95% CI: -6.55 to 0.05; p = 0.054). Regarding Aim 2, 1,177 participants across the 3 allocation method arms completed follow-up (66.5%). There was no effect of allocation method on reduction of unhealthy snacking, including no effect of health literacy screening compared to participant selection (b = 1.79; 95% CI: -0.16 to 3.73; p = 0.067). Key limitations include low-moderate retention, use of a single-occasion self-reported primary outcome, and reporting of a number of extreme, yet plausible, snacking scores, which rendered interpretation more challenging. Adverse events were not assessed.
CONCLUSIONS
In our study we observed nominal improvements in effectiveness of action plans tailored to health literacy; however, these improvements did not reach statistical significance, and the costs associated with such strategies compared with universal precautions need further investigation. This study highlights the importance of considering differential effects of health literacy on intervention effectiveness.
TRIAL REGISTRATION
Australia and New Zealand Clinical Trial Registry ACTRN12618001409268.",2020,"There was no effect of allocation method on reduction of unhealthy snacking, including no effect of health literacy screening compared to participant selection (b = 1.79; 95% CI: -0.16 to 3.73; p = 0.067).","['1,177 participants across the 3 allocation method arms completed follow-up (66.5', 'Australia between 14 February and 6 June 2019', 'people who have high BMI or type 2 diabetes', '398 participants in the random allocation arm completed follow-up (67.7', '1,769 participants (mean age: 49.8 years [SD = 11.7]; 56.1% female [n = 992]; mean BMI: 32.9 kg/m2 [SD = 8.7]; 29.6% self-reported type 2 diabetes [n = 523', 'Australia']","['3 allocation methods (random, health literacy screening, or participant selection) and 1 of 2 action plans to reduce unhealthy snacking (standard versus literacy-sensitive', 'health literacy, screening, and participant choice on action plans', 'health literacy and action plan type']","['Adverse events', 'health literacy (NVS) interaction', 'Average NVS score', 'reduction of unhealthy snacking', 'extent of unhealthy snacking, difficulty using the plans, habit strength, and action control']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517535', 'cui_str': '11.7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0445672', 'cui_str': 'Nutritionally variant streptococci'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",1769.0,0.159274,"There was no effect of allocation method on reduction of unhealthy snacking, including no effect of health literacy screening compared to participant selection (b = 1.79; 95% CI: -0.16 to 3.73; p = 0.067).","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ayre', 'Affiliation': 'Sydney Health Literacy Lab, Faculty of Medicine and Health, School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Cvejic', 'Affiliation': 'Sydney Health Literacy Lab, Faculty of Medicine and Health, School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Carissa', 'Initials': 'C', 'LastName': 'Bonner', 'Affiliation': 'Sydney Health Literacy Lab, Faculty of Medicine and Health, School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Turner', 'Affiliation': 'Centre for Biostatistics, Division of Health Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Walter', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kirsten J', 'Initials': 'KJ', 'LastName': 'McCaffery', 'Affiliation': 'Sydney Health Literacy Lab, Faculty of Medicine and Health, School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003409']
1763,33141921,Differential Effects of Clopidogrel with or without Aspirin on Platelet Reactivity and Coagulation Activation: a randomized trial in healthy volunteers.,"Dual antiplatelet therapy (DAPT) is standard in acute coronary syndrome but confers a bleeding risk. To compare effects of clopidogrel single antiplatelet therapy (SAPT) with clopidogrel-based DAPT on hemostatic system activation we conducted a RCT in 44 volunteers (clopidogrel [d1: 600mg, d2-6: 150 mg] +/- aspirin [100mg]). Adenosine diphosphate (MEA-ADP) and arachidonic acid (MEA-AA) triggered aggregometry, vasodilator-stimulated phosphoprotein (VASP), beta thromboglobulin, p-selectin, thromboxane B 2 , d-Dimer, prothrombin fragment 1.2 (f1.2), and a phospholipid dependent clotting time (PPL) were measured in venous blood. Changes are described by mean differences (Δmean [95% CI]) or geometric mean ratios (GMR [95% CI]). DAPT and SAPT comparably and significantly decreased MEA-ADP at 2h (-60% vs -63%; p=0.35, Δmean -4.9 [-15.4; 5.5]). At 24h (-59% vs -47%, p=0.04, Δmean -11.1 [-21.7; -0.4]) and 8 days (-61% vs -53%, p=0.04, Δmean -11.3 [-22.0; -0.6]). Both treatments significantly reduced VASP and MEA-AA after 2h and 8 days. DAPT inhibited MEA-AA significantly stronger at 2h (-77% vs -30%; p<0.0001, Δmean -39.6 [-54.2; -25.0]), at 24h (-80% vs -27%, p<0.0001, Δmean -47.8 [-62.3; -33.3]), and 8 days (-79% vs -27%, p<0.0001, Δmean -48.9 [-62.5; -35.4]). Neither treatment significantly influenced beta thromboglobulin or p-selectin. DAPT abolished, and SAPT significantly reduced thromboxane B 2 after 24h and 8 days. d-Dimer was reduced by DAPT (0.94 [0.89; 1.00], p=0.04) at 2h but not after 24h and 8 days. SAPT did not decrease d-Dimer. Neither treatment affected f1.2. DAPT and SAPT comparably affect platelet and coagulation activation in venous blood.",2020,"DAPT inhibited MEA-AA significantly stronger at 2h (-77% vs -30%; p<0.0001, Δmean -39.6 [-54.2; -25.0]), at 24h (-80% vs -27%, p<0.0001, Δmean -47.8 [-62.3; -33.3]), and 8 days (-79% vs -27%, p<0.0001, Δmean -48.9 [-62.5; -35.4]).","['44 volunteers (clopidogrel [d1: 600mg, d2-6: 150 mg] ', 'healthy volunteers']","['clopidogrel single antiplatelet therapy (SAPT) with clopidogrel-based DAPT', 'Dual antiplatelet therapy (DAPT', 'Clopidogrel with or without Aspirin', 'Adenosine diphosphate (MEA-ADP) and arachidonic acid (MEA-AA', 'aspirin', 'SAPT', 'DAPT and SAPT']","['DAPT inhibited MEA-AA', 'VASP and MEA-AA', 'MEA-ADP', 'Platelet Reactivity and Coagulation Activation', 'platelet and coagulation activation']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0010648', 'cui_str': 'Cysteamine'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0010648', 'cui_str': 'Cysteamine'}, {'cui': 'C0255567', 'cui_str': 'vasodilator-stimulated phosphoprotein'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}]",44.0,0.0619473,"DAPT inhibited MEA-AA significantly stronger at 2h (-77% vs -30%; p<0.0001, Δmean -39.6 [-54.2; -25.0]), at 24h (-80% vs -27%, p<0.0001, Δmean -47.8 [-62.3; -33.3]), and 8 days (-79% vs -27%, p<0.0001, Δmean -48.9 [-62.5; -35.4]).","[{'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Traby', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Austria.'}, {'ForeName': 'Marietta', 'Initials': 'M', 'LastName': 'Kollars', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kaider Mag', 'Affiliation': 'Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Austria.'}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Maria Siller-Matula', 'Affiliation': 'Department of Medicine II, Division of Cardiology, Medical University of Vienna, Austria.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Steinbrecher', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wolzt', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Paul Alexander', 'Initials': 'PA', 'LastName': 'Kyrle', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Eichinger', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Austria.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2106']
1764,33141923,"OATP Inhibition Dramatically Increases Plasma Exposure, but not Pharmacodynamic Effect nor Inferred Hepatic Intracellular Exposure, of Firsocostat.","Firsocostat (FIR: previously GS-0976), a highly sensitive OATP substrate, reduces hepatic de novo lipogenesis (DNL) by inhibiting acetyl-CoA carboxylases (ACC). Measuring the pharmacodynamic (PD) efficacy of FIR on DNL provides a unique opportunity to determine optimal dosing strategies for liver-targeted OATP substrates in settings of altered OATP function. A randomized, four-way cross-over drug-drug interaction study was conducted. Hepatic de-novo lipogenesis (DNL), a marker for ACC activity, was measured in 28 healthy volunteers after reference, single dose FIR 10 mg, FIR 10 mg plus the OATP inhibitor rifampin (RIF) 300 mg IV, or RIF 300 mg IV (control for DNL effect of rifampin), each separated by a 7-day washout. Samples were collected for PK and PD assessments through 24 hours after each treatment. Hepatic DNL and its inhibition by FIR were assessed. Twenty-four subjects completed the study. All AEs were mild. Rifampin alone increased hepatic DNL AUEC last (35.7%). Despite a 5.2-fold increase in FIR plasma exposure (AUC inf ) when administered with RIF, FIR alone and FIR + RIF had the same hepatic PD effect, 37.1% and 34.9% reduction in DNL AUEC last , respectively, compared with their respective controls. These findings indicate that large decreases in OATP activity do not alter hepatic intracellular exposure (as inferred by no change in PD) for drugs that are primarily eliminated hepatically and permeability rate-limited, such as FIR. These results support PK theory that has been difficult to test and provide practical guidance on administration of liver-targeted drugs in settings of reduced OATP function.",2020,"Despite a 5.2-fold increase in FIR plasma exposure (AUC inf ) when administered with RIF, FIR alone and FIR + RIF had the same hepatic PD effect, 37.1% and 34.9% reduction in DNL AUEC last , respectively, compared with their respective controls.","['28 healthy volunteers', 'Twenty-four subjects completed the study']","['Rifampin', 'OATP inhibitor rifampin (RIF) 300 mg IV, or RIF 300 mg IV (control for DNL effect of rifampin']","['OATP activity', 'hepatic PD effect', 'FIR plasma exposure (AUC inf ', 'pharmacodynamic (PD) efficacy', 'hepatic DNL AUEC last']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0949791', 'cui_str': 'OATP Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1595588', 'cui_str': 'Rifampin 300 MG [Rifadin]'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0596843', 'cui_str': 'Adipogenesis'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]","[{'cui': 'C0949791', 'cui_str': 'OATP Proteins'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4743336', 'cui_str': 'firsocostat'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0596843', 'cui_str': 'Adipogenesis'}]",28.0,0.0505714,"Despite a 5.2-fold increase in FIR plasma exposure (AUC inf ) when administered with RIF, FIR alone and FIR + RIF had the same hepatic PD effect, 37.1% and 34.9% reduction in DNL AUEC last , respectively, compared with their respective controls.","[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Kirby', 'Affiliation': 'Department of Clinical Pharmacology, Gilead Sciences Inc, Foster City, CA.'}, {'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Lutz', 'Affiliation': 'Department of Clinical Pharmacology, Gilead Sciences Inc, Foster City, CA.'}, {'ForeName': 'Mun Sang', 'Initials': 'MS', 'LastName': 'Yue', 'Affiliation': 'Department of Clinical Pharmacology, Gilead Sciences Inc, Foster City, CA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Garrison', 'Affiliation': 'Department of Clinical Pharmacology, Gilead Sciences Inc, Foster City, CA.'}, {'ForeName': 'Ann Ran-Ran', 'Initials': 'AR', 'LastName': 'Qin', 'Affiliation': 'Department of Clinical Pharmacology, Gilead Sciences Inc, Foster City, CA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Ampaw', 'Affiliation': 'Department of Clinical Operations, Gilead Sciences Inc, Foster City, CA.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Beysen', 'Affiliation': 'Independent Researcher, San Mateo, CA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Myers', 'Affiliation': 'Department of Clinical Research, Gilead Sciences Inc, Foster City, CA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Kearney', 'Affiliation': 'Department of Clinical Pharmacology, Gilead Sciences Inc, Foster City, CA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Mathias', 'Affiliation': 'Department of Clinical Pharmacology, Gilead Sciences Inc, Foster City, CA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2105']
1765,33141935,Immediate placement of single implants with or without immediate provisionalization in the maxillary aesthetic region: a 5-year comparative study.,"AIM
To compare marginal bone level changes around immediately placed and immediately provisionalized implants with immediately placed and delayed provisionalized implants in the aesthetic region after five years of function.
MATERIALS AND METHODS
Forty patients with a failing tooth in the maxillary anterior region were randomly assigned immediate implant placement with immediate (Group A: n=20) or delayed (Group B: n=20) provisionalization. Definitive crown placement occurred three months after provisionalization. The primary outcomes were changes in marginal bone level. In addition, survival rates, buccal bone thickness, soft peri-implant tissues, aesthetics and patient reported outcomes were assessed.
RESULTS
After 5 years, the mean mesial and distal marginal bone level changes were 0.71±0.68mm and 0.71±0.71mm respectively in Group A and 0.49±0.52mm and 0.54±0.64mm respectively in Group B; the difference between the groups was not significant (p=0.305 and p=0.477 respectively). Implant and restoration survivals were 100%. No clinically relevant differences in buccal bone thickness or in midfacial peri-implant mucosal level, aesthetic and patient outcomes were observed.
CONCLUSIONS
The mean marginal bone level changes following immediate implant placement and provisionalization were comparable with immediate implant placement and delayed provisionalization. (www.isrctn.com: ISRCTN57251089 and www.trialregister.nl: NL8255).",2020,"No clinically relevant differences in buccal bone thickness or in midfacial peri-implant mucosal level, aesthetic and patient outcomes were observed.
","['Group A: n=20) or delayed (Group B: n=20) provisionalization', 'maxillary aesthetic region', 'www.isrctn.com', 'Forty patients with a failing tooth in the maxillary anterior region']","['single implants with or without immediate provisionalization', 'immediate implant placement with immediate', 'provisionalized implants with immediately placed and delayed provisionalized implants']","['mean mesial and distal marginal bone level changes', 'marginal bone level', 'buccal bone thickness', 'Implant and restoration survivals', 'mean marginal bone level changes', 'survival rates, buccal bone thickness, soft peri-implant tissues, aesthetics']","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0020671', 'cui_str': 'Structure of supraoptic region of hypothalamus'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}]",40.0,0.160457,"No clinically relevant differences in buccal bone thickness or in midfacial peri-implant mucosal level, aesthetic and patient outcomes were observed.
","[{'ForeName': 'Kirsten W', 'Initials': 'KW', 'LastName': 'Slagter', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Oral and Maxillofacial Surgery, Groningen, The Netherlands.'}, {'ForeName': 'Gerry M', 'Initials': 'GM', 'LastName': 'Raghoebar', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Oral and Maxillofacial Surgery, Groningen, The Netherlands.'}, {'ForeName': 'Diederik F M', 'Initials': 'DFM', 'LastName': 'Hentenaar', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Oral and Maxillofacial Surgery, Groningen, The Netherlands.'}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'Vissink', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Oral and Maxillofacial Surgery, Groningen, The Netherlands.'}, {'ForeName': 'Henny J A', 'Initials': 'HJA', 'LastName': 'Meijer', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Oral and Maxillofacial Surgery, Groningen, The Netherlands.'}]",Journal of clinical periodontology,['10.1111/jcpe.13398']
1766,33142340,Perinatal Outcomes of Subjects Enrolled in a Multicenter Trial with a Waiver of Antenatal Consent.,"OBJECTIVE
This study aimed to determine whether outcomes differed between infants enrolled in the PREMOD2 trial and those otherwise eligible but not enrolled, and whether the use of waiver effected these differences.
STUDY DESIGN
The multicenter PREMOD2 (PREmature infants receiving Milking Or Delayed cord clamping) trial was approved for waiver of antenatal consent by six of the nine sites institutional review boards, while three sites exclusively used antenatal consent. Every randomized subject delivered at a site with a waiver of consent was approached for postnatal consent to allow for data collection. Four of those six sites' IRBs required the study team to attempt antenatal consent when possible. Three sites exclusively used antenatal consent.
RESULTS
Enrolled subjects had higher Apgar scores, less use of positive pressure ventilation, a lower rate of bronchopulmonary dysplasia, and a less frequent occurrence of the combined outcome of severe intraventricular hemorrhage or death. A significantly greater number of infants were enrolled at sites with an option of waiver of consent (66 vs. 26%, risk ratio = 2.54, p < 0.001). At sites with an option of either approaching families before delivery or after delivery with a waiver of antenatal consent, those approached prior to delivery refused consent 40% (range 15-74% across six sites) of the time.
CONCLUSION
PREMOD2 trial demonstrated analytical validity limitations because of the variable mix of antenatal consent and waiver of consent. A waiver of antenatal consent for minimal risk interventional trials conducted during the intrapartum period will be more successful in enrolling a representative sample of low and high-risk infants if investigators are able to enroll all eligible subjects.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT03019367.
KEY POINTS
· Waiver of consent is when informed consent cannot be obtained prior to delivery.. · Cord milking is a procedure in which blood is pushed (stripped) two to four times towards the newborn.. · Delayed clamping means the umbilical cord is not clamped immediately after birth..",2020,"RESULTS
Enrolled subjects had higher Apgar scores, less use of positive pressure ventilation, a lower rate of bronchopulmonary dysplasia, and a less frequent occurrence of the combined outcome of severe intraventricular hemorrhage or death.","['Subjects Enrolled in a Multicenter Trial with a Waiver of Antenatal Consent', 'PREmature infants receiving Milking Or Delayed cord clamping) trial was approved for waiver of antenatal consent by six of the nine sites institutional review boards, while three sites exclusively used antenatal consent']",[],"['rate of bronchopulmonary dysplasia', 'positive pressure ventilation', 'higher Apgar scores', 'severe intraventricular hemorrhage or death']","[{'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}]",[],"[{'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0612106,"RESULTS
Enrolled subjects had higher Apgar scores, less use of positive pressure ventilation, a lower rate of bronchopulmonary dysplasia, and a less frequent occurrence of the combined outcome of severe intraventricular hemorrhage or death.","[{'ForeName': 'Anup C', 'Initials': 'AC', 'LastName': 'Katheria', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Allman', 'Affiliation': 'Department of Biostatistics, The UAB School of Public Health, Birmingham, Alabama.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Szychowski', 'Affiliation': 'Department of Biostatistics, The UAB School of Public Health, Birmingham, Alabama.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Essers', 'Affiliation': 'Department of Pediatrics, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Georg M', 'Initials': 'GM', 'LastName': 'Schmölzer', 'Affiliation': 'Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Dempsey', 'Affiliation': 'Department of Paediatrics and INFANT Centre, University College Cork, Cork, Ireland.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Yanowitz', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kaempf', 'Affiliation': ""Women and Children's Services, Providence St. Vincent Medical Center, Portland, Oregon.""}, {'ForeName': 'Farha', 'Initials': 'F', 'LastName': 'Vora', 'Affiliation': 'Department of Pediatrics, Loma Linda University, Loma Linda, California.'}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Bhat', 'Affiliation': 'Department of Pediatrics, ChristianaCare Health System, Newark, Delaware.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Arnell', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'Wade', 'Initials': 'W', 'LastName': 'Rich', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Varner', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah.'}]",American journal of perinatology,['10.1055/s-0040-1719184']
1767,33142849,The Effect of Training Status on Adaptations to 11 Weeks of Block Periodization Training.,"Some controversy exists as to the most efficacious method of training to achieve enhanced levels of sport performance. Controversy concerning the efficacy of periodization and especially block periodization (BP) likely stems from the use of poorly or untrained subjects versus trained who may differ in their responses to a stimulus. The purpose of this study was to investigate the effect of training status on performance outcomes resulting from 11 weeks of BP training. Fifteen males were recruited for this study and placed into strong (age = 24.3 ± 1.9 years., body mass (BM) = 87.7 ± 8.7 kg, squat: body mass = 1.96 ± 0.16), moderate (age = 25.3 ± 2.7 years., body mass = 100.2 ± 15.5 kg, squat: body mass = 1.46 ± 0.14), or weak (age = 23.2 ± 3.9 yrs., body mass = 83.5 ± 17.1 kg, squat: body mass = 1.17 ± 0.07) groups based on relative strength. Testing was completed at baseline, and after each block which consisted of 1 repetition maximum (1RM) squat, 0 kg static jump (SJ), 0 kg countermovement jump (CMJ), 20 kg SJ, and 20 kg CMJ. Absolute and relative strength were strongly correlated with rates of improvement for absolute strength, relative strength, 0 kg, and 20 kg vertical jumps. All subjects substantially improved back squat ( p < 0.001), relative back squat ( p < 0.001) with large-very large effect sizes between groups for percent change favoring the weak group over the moderate and strong group for all performance variables. All subjects showed statistically significant improvements in 0 kg SJ ( p < 0.001), 0 kg CMJ ( p < 0.001), 20 kg SJ ( p = 0.002), and 20 kg CMJ ( p < 0.001). Statistically significant between group differences were noted for both 20 kg SJ ( p = 0.01) and 20 kg CMJ ( p = 0.043) with the strong group statistically greater jump heights than the weak group. The results of this study indicate BP training is effective in improving strength and explosive ability. Additionally, training status may substantially alter the response to a resistance training program.",2020,"All subjects showed statistically significant improvements in 0 kg SJ ( p < 0.001), 0 kg CMJ (","['Fifteen males were recruited for this study and placed into strong (age = 24.3 ± 1.9 years', ' body mass = 100.2 ± 15.5 kg, squat: body mass = 1.46 ± 0.14), or weak (age = 23.2 ± 3.9 yrs., body mass = 83.5 ± 17.1 kg, squat: body mass = 1.17 ± 0.07) groups based on relative strength']","['Block Periodization Training', 'BP training']","['Absolute and relative strength', 'jump heights', 'back squat', '0 kg SJ', 'strength and explosive ability', 'relative back squat']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C5191363', 'cui_str': '1.46'}, {'cui': 'C4517430', 'cui_str': '0.14'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C4517494', 'cui_str': '1.17'}, {'cui': 'C4518239', 'cui_str': '0.07'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0015330', 'cui_str': 'Explosive device'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",15.0,0.031605,"All subjects showed statistically significant improvements in 0 kg SJ ( p < 0.001), 0 kg CMJ (","[{'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Wetmore', 'Affiliation': 'Center of Excellence for Sport Science and Coach Education, Department of Sport, Exercise, Recreation and Kinesiology, East Tennessee State University, Johnson City, TN 37614, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Moquin', 'Affiliation': 'Center of Excellence for Sport Science and Coach Education, Department of Sport, Exercise, Recreation and Kinesiology, East Tennessee State University, Johnson City, TN 37614, USA.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': 'Center of Excellence for Sport Science and Coach Education, Department of Sport, Exercise, Recreation and Kinesiology, East Tennessee State University, Johnson City, TN 37614, USA.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Fry', 'Affiliation': 'Osness Human Performance Laboratories, Department of Health, Sport, and Exercise Sciences, University of Kansas, Lawrence, KS 66045, USA.'}, {'ForeName': 'W Guy', 'Initials': 'WG', 'LastName': 'Hornsby', 'Affiliation': 'College of Physical Activity and Sport Sciences, West Virginia University, Morgantown, WV 26505, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Stone', 'Affiliation': 'Center of Excellence for Sport Science and Coach Education, Department of Sport, Exercise, Recreation and Kinesiology, East Tennessee State University, Johnson City, TN 37614, USA.'}]","Sports (Basel, Switzerland)",['10.3390/sports8110145']
1768,33142850,Ambulatory Neuroproprioceptive Facilitation and Inhibition Physical Therapy Improves Clinical Outcomes in Multiple Sclerosis and Modulates Serum Level of Neuroactive Steroids: A Two-Arm Parallel-Group Exploratory Trial.,"Background : Only few studies have monitored the potential of physical activity training and physical therapy to modulate the reaction of the endocrine system. In this study, the effect of neuroproprioceptive facilitation and inhibition physical therapy on clinical outcomes and neuroactive steroids production in people with multiple sclerosis was evaluated. Moreover, we were interested in the factors that influence the treatment effect.
METHODS
In total, 44 patients with multiple sclerosis were randomly divided into two groups. Each group underwent a different kind of two months ambulatory therapy (Motor program activating therapy and Vojta's reflex locomotion). During the following two months, participants were asked to continue the autotherapy. Primary (serum level of cortisol, cortisone, 7α-OH-DHEA, 7β-OH-DHEA, 7-oxo-DHEA, DHEA) and secondary (balance, cognition and patient-reported outcomes) outcomes were examined three times (pre, post, and washout assessments).
RESULTS
In both groups, there is a decreasing trend of 7-oxo-DHEA concentration in post-assessment and 7β-OH-DHEA in washout versus pre-assessment. A higher impact on neuroactive steroids is visible after Vojta's reflex locomotion. As for clinical outcomes, the Paced Auditory Serial Addition Test and Multiple Sclerosis Impact Scale significantly improved between post-assessment and washout assessment. The improvement was similar for both treatments.
CONCLUSIONS
Neuroproprioceptive facilitation and inhibition improved the clinical outcomes and led to non-significant changes in neuroactive steroids. Trial registration (NCT04379193).",2020,"As for clinical outcomes, the Paced Auditory Serial Addition Test and Multiple Sclerosis Impact Scale significantly improved between post-assessment and washout assessment.","['people with multiple sclerosis', '44 patients with multiple sclerosis']","['neuroproprioceptive facilitation and inhibition physical therapy', 'Ambulatory Neuroproprioceptive Facilitation and Inhibition Physical Therapy', 'physical activity training and physical therapy', ""ambulatory therapy (Motor program activating therapy and Vojta's reflex locomotion""]","['Primary (serum level of cortisol, cortisone, 7α-OH-DHEA, 7β-OH-DHEA, 7-oxo-DHEA, DHEA) and secondary (balance, cognition and patient-reported outcomes) outcomes', 'Paced Auditory Serial Addition Test and Multiple Sclerosis Impact Scale', '7-oxo-DHEA concentration']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0393003', 'cui_str': 'potassium oxonate'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0589060', 'cui_str': 'Paced auditory serial addition test'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",44.0,0.0339919,"As for clinical outcomes, the Paced Auditory Serial Addition Test and Multiple Sclerosis Impact Scale significantly improved between post-assessment and washout assessment.","[{'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Angelova', 'Affiliation': 'Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University, Ruska 87, 10000 Prague 10, Czech Republic.'}, {'ForeName': 'Tereza', 'Initials': 'T', 'LastName': 'Skodova', 'Affiliation': 'Department of Steroids and Proteofactors, Institute of Endocrionology, 11694 Prague, Czech Republic.'}, {'ForeName': 'Terezie', 'Initials': 'T', 'LastName': 'Prokopiusova', 'Affiliation': 'Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University, Ruska 87, 10000 Prague 10, Czech Republic.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Markova', 'Affiliation': 'Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University, Ruska 87, 10000 Prague 10, Czech Republic.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Hruskova', 'Affiliation': 'Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University, Ruska 87, 10000 Prague 10, Czech Republic.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Prochazkova', 'Affiliation': 'Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University, Ruska 87, 10000 Prague 10, Czech Republic.'}, {'ForeName': 'Marketa', 'Initials': 'M', 'LastName': 'Pavlikova', 'Affiliation': 'Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University, Ruska 87, 10000 Prague 10, Czech Republic.'}, {'ForeName': 'Sarka', 'Initials': 'S', 'LastName': 'Spanhelova', 'Affiliation': 'Department of Rehabilitation and Sport Medicine, Motol University Hospital, V Uvalu 84, 150 06 Prague 5, Czech Republic.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Stetkarova', 'Affiliation': 'Department of Neurology, Third Faculty of Medicine, Charles University, 10000 Prague, Czech Republic.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bicikova', 'Affiliation': 'Department of Steroids and Proteofactors, Institute of Endocrionology, 11694 Prague, Czech Republic.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Kolatorova', 'Affiliation': 'Department of Steroids and Proteofactors, Institute of Endocrionology, 11694 Prague, Czech Republic.'}, {'ForeName': 'Kamila', 'Initials': 'K', 'LastName': 'Rasova', 'Affiliation': 'Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University, Ruska 87, 10000 Prague 10, Czech Republic.'}]","Life (Basel, Switzerland)",['10.3390/life10110267']
1769,33142973,Evaluation of Three Methods for CPR Training to Lifeguards: A Randomised Trial Using Traditional Procedures and New Technologies.,"Background and objectives: When the drowning timeline evolves and drowning occurs, the lifeguard tries to mitigate the event by applying the last link of the drowning survival chain with the aim of treating hypoxia. Quality CPR (Cardiopulmonary Resuscitation) and the training of lifeguards are the fundamental axes of drowning survival. Mobile applications and other feedback methods have emerged as strong methods for the learning and training of basic CPR in the last years so, in this study, a randomised clinical trial has been carried out to compare the traditional method as the use of apps or manikins with a feedback system as a method of training to improve the quality of resuscitation. Materials and Methods: The traditional training (TT), mobile phone applications (AP) and feedback manikins (FT) are compared. The three cohorts were subsequently evaluated through a manikin providing feedback, and a data report on the quality of the manoeuvres was obtained. Results: Significant differences were found between the traditional manikin and the manikin with real-time feedback regarding the percentage of compressions with correct depth (30.8% (30.4) vs. 68.2% (32.6); p = 0.042). Hand positioning, percentage correct chest recoil and quality of compressions exceeded 70% of correct performance in all groups with better percentages in the FT (TT vs. FT; p < 0.05). Conclusions: As a conclusion, feedback manikins are better learning tools than traditional models and apps as regards training chest compression. Ventilation values are low in all groups, but improve with the feedback manikin.",2020,"Mobile applications and other feedback methods have emerged as strong methods for the learning and training of basic CPR in the last years so, in this study, a randomised clinical trial has been carried out to compare the traditional method as the use of apps or manikins with a feedback system as a method of training to improve the quality of resuscitation. ",['CPR Training to Lifeguards'],"['traditional training (TT), mobile phone applications (AP) and feedback manikins (FT']","['manikin with real-time feedback regarding the percentage of compressions with correct depth', 'Ventilation values', 'Quality CPR (Cardiopulmonary Resuscitation', 'percentage correct chest recoil and quality of compressions']","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}]","[{'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]",,0.0261268,"Mobile applications and other feedback methods have emerged as strong methods for the learning and training of basic CPR in the last years so, in this study, a randomised clinical trial has been carried out to compare the traditional method as the use of apps or manikins with a feedback system as a method of training to improve the quality of resuscitation. ","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'González-Santano', 'Affiliation': 'Princesa University Hospital, 28006 Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fernández-García', 'Affiliation': 'University Hospital of Leon, 24071 León, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Silvestre-Medina', 'Affiliation': 'Princesa University Hospital, 28006 Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Remuiñán-Rodríguez', 'Affiliation': 'University Hospital Complex A Coruña, Galician Health Service (SERGAS), University of A Coruña, 15006 A Coruña, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rosell-Ortiz', 'Affiliation': 'La Rioja 061 Emergency and Urgent Care Department, 26007 Logroño, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gómez-Salgado', 'Affiliation': 'Department of Sociology, Social Work and Public Health, Faculty of Labour Sciences, University of Huelva, 21007 Huelva, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Sobrido-Prieto', 'Affiliation': 'Department of Health Sciences, School of Nursing and Podiatry, University of A Coruña, 15006 A Coruña, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Ordás-Campos', 'Affiliation': 'University Hospital of Leon, 24071 León, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Martínez-Isasi', 'Affiliation': ""CLINURSID Research Group, Santiago de Compostela's Health Research Institute (IDIS), Faculty of Nursing, University of Santiago de Compostela, 15705 Santiago de Compostela, Galicia, Spain.""}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56110577']
1770,33142988,Effects of Advertising on Food Consumption Preferences in Children.,"(1) Background: Childhood obesity is a public health problem. The purpose of this study was to know if exposure to commercial messages which advertise food products exerts any effect on the short-term consumption preferences of 4- to 6-year-old children. (2) Methods: A double-blind and randomized experimental design. Sample consisted of 421 boys and girls from twelve schools in a city in Spain. (3) Results: In three of the four product pairs shown, the products advertised in the intervention were preferred. In the results of applying the model for the first product pair presented, sugared cereals, the predictive variable which best explains the behavior of the preferences expressed is gender (Odds Ratio 0.285 (0.19-0.42); p < 0.05). For the second pair, chocolate cookies, the family's nationality has a strong weight in the model. As regards the regression model calculated for the last pair (filled rolls), the predictive variable which showed having more influence was gender. Boys had a 1.39 times higher risk of selecting the advertised product than girls. (4) Conclusions: The persuasive effect of commercials has shown to be influential in a general, immediate, and significant way only in the case of products with wide brand awareness. This study reinforces the importance of advertising and emphasizes the need to initiate measures to control the content of TV commercials.",2020,"As regards the regression model calculated for the last pair (filled rolls), the predictive variable which showed having more influence was gender.","['4- to 6-year-old children', '421 boys and girls from twelve schools in a city in Spain', 'Children']",[],[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],[],421.0,0.0578635,"As regards the regression model calculated for the last pair (filled rolls), the predictive variable which showed having more influence was gender.","[{'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Ponce-Blandón', 'Affiliation': 'Red Cross Nursing School, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pabón-Carrasco', 'Affiliation': 'Red Cross Nursing School, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Romero-Castillo', 'Affiliation': 'Red Cross Nursing School, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'Macarena', 'Initials': 'M', 'LastName': 'Romero-Martín', 'Affiliation': 'Red Cross Nursing School, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Jiménez-Picón', 'Affiliation': 'Red Cross Nursing School, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'María de Las Mercedes', 'Initials': 'MLM', 'LastName': 'Lomas-Campos', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, 41009 Seville, Spain.'}]",Nutrients,['10.3390/nu12113337']
1771,33137742,When a robot teaches humans: Automated feedback selection accelerates motor learning.,"A multitude of robotic systems have been developed to foster motor learning. Some of these robotic systems featured augmented visual or haptic feedback, which was automatically adjusted to the trainee's performance. However, selecting the type of feedback to achieve the training goal usually remained up to a human trainer. We automated this feedback selection within a robotic rowing simulator: Four spatial errors and one velocity error were considered, all related to trunk-arm sweep rowing set as the training goal to be learned. In an alternating sequence of assessments without augmented feedback and training sessions with augmented, concurrent feedback, the experimental group received feedback, thus addressing the main shortcoming of the previous assessment. With this approach, each participant of the experimental group received an individual sequence of 10 training sessions with feedback. The training sequences from participants in the experimental group were consecutively applied for participants in the control group. Both groups were able to reduce spatial and velocity errors due to training. The learning rate of the requested velocity profile was significantly higher for the experimental group compared with the control group. Thus, our robotic rowing simulator accelerated motor learning by automated feedback selection. This demonstration of a working, closed-loop selection of types of feedback, i.e., training conditions, could serve as the basis for other robotic trainers incorporating further human expertise and artificial intelligence.",2019,The learning rate of the requested velocity profile was significantly higher for the experimental group compared with the control group.,[],[],"['visual or haptic feedback', 'learning rate of the requested velocity profile']",[],[],"[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",,0.0196266,The learning rate of the requested velocity profile was significantly higher for the experimental group compared with the control group.,"[{'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Rauter', 'Affiliation': 'Sensory-Motor Systems Lab, Department of Health Sciences and Technology, ETH Zurich, Zurich, Switzerland. georg.rauter@unibas.ch.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Gerig', 'Affiliation': 'Sensory-Motor Systems Lab, Department of Health Sciences and Technology, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Sigrist', 'Affiliation': 'Sensory-Motor Systems Lab, Department of Health Sciences and Technology, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Riener', 'Affiliation': 'Sensory-Motor Systems Lab, Department of Health Sciences and Technology, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wolf', 'Affiliation': 'Sensory-Motor Systems Lab, Department of Health Sciences and Technology, ETH Zurich, Zurich, Switzerland.'}]",Science robotics,['10.1126/scirobotics.aav1560']
1772,33137789,"Effects of Time in Sitting and Standing on Pleasantness, Acceptability, Fatigue, and Pain When Using a Sit-Stand Desk: An Experiment on Overweight and Normal-Weight Subjects.","BACKGROUND
Sit-stand desks have been suggested as an initiative to increase posture variation among office workers. However, there is limited evidence of what would be preferable combinations of time sitting and standing. The aim of this study was to determine and compare perceived pleasantness, acceptability, pain, and fatigue for 5 time patterns of sitting and standing at a sit-stand desk.
METHODS
Thirty postgraduate students were equally divided into a normal-weight (mean body mass index 22.8 kg/m2) and an overweight/obese (mean body mass index 28.1 kg/m2) group. They performed 3 hours of computer work at a sit-stand desk on 5 different days, each day with a different time pattern (A: 60-min sit/0-min stand; B: 50/10; C: 40/20; D: 30/30; E: 20/40). Pleasantness, acceptability, pain, and fatigue ratings were obtained at the beginning and at the end of the 3-hour period.
RESULTS
High ratings of pleasantness were observed for time patterns B, C, and D in both groups. All participants rated acceptability to be good for time patterns A to D. A minor increase in perceived fatigue and pain was observed in time pattern E.
CONCLUSION
For new sit-stand desk users, regardless of body mass index, 10 to 30 minutes of standing per hour appears to be an amenable time pattern.",2020,"RESULTS
High ratings of pleasantness were observed for time patterns B, C, and D in both groups.","['Overweight and Normal-Weight Subjects', 'Thirty postgraduate students were equally divided into a normal-weight (mean body mass index 22.8\xa0kg/m2) and an overweight/obese (mean body mass index 28.1\xa0kg/m2) group']",[],"['Time in Sitting and Standing on Pleasantness, Acceptability, Fatigue, and Pain', 'Pleasantness, acceptability, pain, and fatigue ratings', 'perceived fatigue and pain', 'perceived pleasantness, acceptability, pain, and fatigue']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",30.0,0.0399418,"RESULTS
High ratings of pleasantness were observed for time patterns B, C, and D in both groups.","[{'ForeName': 'Dechristian França', 'Initials': 'DF', 'LastName': 'Barbieri', 'Affiliation': ''}, {'ForeName': 'Luiz Augusto', 'Initials': 'LA', 'LastName': 'Brusaca', 'Affiliation': ''}, {'ForeName': 'Svend Erik', 'Initials': 'SE', 'LastName': 'Mathiassen', 'Affiliation': ''}, {'ForeName': 'Ana Beatriz', 'Initials': 'AB', 'LastName': 'Oliveira', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2020-0328']
1773,33137868,"The Impact of a Motor Imagery-Based Training Program on Agility, Speed, and Reaction Time in a Sample of Young Tennis Athletes during Ramadan Fasting: Insights and Implications from a Randomized, Controlled Experimental Trial.","The objective of this study was to explore whether a training program incorporating motor imagery could have an effect on physical performance outcomes in terms of agility, speed, and reaction time in a sample of tennis athletes who fasted during the month of Ramadan. Recruited subjects were 27 young male tennis players, randomly allocated to two groups: the imaging training group ( n = 13) and a control group ( n = 14). The study was designed as a randomized, controlled experimental study. The control group was engaged in watching videos concerning the history of the Olympic Games, whereas the motor imagery group followed a motor imagery-based training program. Physical performance outcomes were assessed during four sessions (one before Ramadan and three during Ramadan) by means of field tests. Our results revealed a drop in all performance outcomes measured in the middle and at the end of Ramadan for both groups ( p < 0.01). The effect of the group × time interaction ( p < 0.01) was reported for all physical performance outcomes measured for the two groups. This drop in performance was greater for the control group compared to the motor imagery group in the middle and at the end of Ramadan. This study showed that fasting during Ramadan reduced agility, speed, and reaction time performance for tennis players. A motor imagery-based training program could be an effective approach to reduce the effect of fasting during Ramadan and stabilize physical performance outcomes in terms of agility, speed, and reaction time for male tennis players.",2020,This drop in performance was greater for the control group compared to the motor imagery group in the middle and at the end of Ramadan.,"['Recruited subjects were 27 young male tennis players', 'tennis athletes who fasted during the month of Ramadan', 'tennis players', 'male tennis players', 'Young Tennis Athletes during Ramadan Fasting']","['watching videos concerning the history of the Olympic Games, whereas the motor imagery group followed a motor imagery-based training program', 'imaging training group', 'Motor Imagery-Based Training Program', 'training program incorporating motor imagery', 'motor imagery-based training program']","['agility, speed, and reaction time', 'Agility, Speed, and Reaction Time', 'agility, speed, and reaction time performance', 'Physical performance outcomes']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",27.0,0.0349166,This drop in performance was greater for the control group compared to the motor imagery group in the middle and at the end of Ramadan.,"[{'ForeName': 'Sofien', 'Initials': 'S', 'LastName': 'Fekih', 'Affiliation': 'Higher Institute of Sport and Physical Education of Gafsa, Gafsa 2100, Tunisia.'}, {'ForeName': 'Mohamed Sami', 'Initials': 'MS', 'LastName': 'Zguira', 'Affiliation': 'Higher Institute of Sport and Physical Education of Gafsa, Gafsa 2100, Tunisia.'}, {'ForeName': 'Abdessalem', 'Initials': 'A', 'LastName': 'Koubaa', 'Affiliation': 'Higher Institute of Sport and Physical Education of Gafsa, Gafsa 2100, Tunisia.'}, {'ForeName': 'Imed', 'Initials': 'I', 'LastName': 'Ghariani', 'Affiliation': 'National Centre of Medicine and Science in Sport, Tunis 2000, Tunisia.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Zguira', 'Affiliation': 'Higher Institute of Sport and Physical Education of Gafsa, Gafsa 2100, Tunisia.'}, {'ForeName': 'Nicola Luigi', 'Initials': 'NL', 'LastName': 'Bragazzi', 'Affiliation': 'Postgraduate School of Public Health, Department of Health Sciences (DISSAL), Genoa University, 16132 Genoa, Italy.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Jarraya', 'Affiliation': 'Research Laboratory: Education, Motricity, Sports and Health (EM2S, LR19JS01), Higher Institute of Sport and Physical Education of Sfax, University of Sfax, Sfax 3100, Tunisia.'}]",Nutrients,['10.3390/nu12113306']
1774,33137900,Acceptability and Feasibility of a Sedentary Behavior Reduction Program during Pregnancy: A Semi-Experimental Study.,"Physical activity (PA) during pregnancy is associated with maternal benefits. Therefore, innovative strategies that promote PA are needed. This study investigated the acceptability and feasibility of a sedentary behavior (SB) reduction program during pregnancy. The study employed a semi-experimental research design using historical control subjects. The intervention group program consisted of individual face-to-face guidance, automatic alerts during SB from wearable devices, and self-monitoring of SB patterns, from 20 gestation weeks to delivery. PA and SB, assessed using a wearable device, were compared with those of the control group at 24-27 (T1) and 32-35 (T2) weeks of gestation. In 56 women, the mean wearing time was 90.2 days in the intervention phase. The response rate to automatic SB alerts was 55.5% at T1 and 63.0% at T2. Self-monitoring more than twice or thrice a week was 77.8% at T1 and 59.3% at T2. There was no significant difference in the cumulative SB time at T2 between the two groups (F = 2.31, p = 0.132). This program appears to be acceptable and feasible for pregnant women; however, SB reduction effect of the intervention remains unclear. Improvements to increase the response rate to automatic SB alerts and the frequency of self-monitoring are needed.",2020,The response rate to automatic SB alerts was 55.5% at T1 and 63.0% at T2.,"['pregnant women', 'historical control subjects', '56 women']","['Sedentary Behavior Reduction Program', 'sedentary behavior (SB) reduction program']","['Physical activity (PA', 'Acceptability and Feasibility', 'mean wearing time', 'response rate to automatic SB alerts', 'cumulative SB time']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}]",56.0,0.019979,The response rate to automatic SB alerts was 55.5% at T1 and 63.0% at T2.,"[{'ForeName': 'Maiko', 'Initials': 'M', 'LastName': 'Kawajiri', 'Affiliation': ""Department of Women's Health Nursing & Midwifery, Tohoku University Graduate School of Medicine, Sendai, Miyagi 9808575, Japan.""}, {'ForeName': 'Yasuka', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': ""Department of Women's Health Nursing & Midwifery, Tohoku University Graduate School of Medicine, Sendai, Miyagi 9808575, Japan.""}, {'ForeName': 'Mikako', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': ""Department of Women's Health Nursing & Midwifery, Tohoku University Graduate School of Medicine, Sendai, Miyagi 9808575, Japan.""}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Takeishi', 'Affiliation': ""Department of Women's Health Nursing & Midwifery, Tohoku University Graduate School of Medicine, Sendai, Miyagi 9808575, Japan.""}, {'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Masaki', 'Affiliation': 'Department of Nursing, Tohoku University Hospital, Sendai, Miyagi 9808575, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Nursing, Tohoku University Hospital, Sendai, Miyagi 9808575, Japan.'}, {'ForeName': 'Satomi', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Department of Nursing, Tohoku University Hospital, Sendai, Miyagi 9808575, Japan.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Kodera', 'Affiliation': 'Department of Nursing, Tohoku University Hospital, Sendai, Miyagi 9808575, Japan.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Chiba', 'Affiliation': 'Department of Nursing, Tohoku University Hospital, Sendai, Miyagi 9808575, Japan.'}, {'ForeName': 'Toyoko', 'Initials': 'T', 'LastName': 'Yoshizawa', 'Affiliation': ""Department of Women's Health Nursing & Midwifery, Tohoku University Graduate School of Medicine, Sendai, Miyagi 9808575, Japan.""}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8040439']
1775,33137970,Effects of Implementing the Timed and Targeted Counselling Model on Pregnancy Outcomes and Newborn Survival in Rural Uganda: Protocol for a Quasi-Experimental Study.,"BACKGROUND
Although mortality rates have declined in Uganda over the last decade, maternal mortality is still high at 336 deaths per 100,000 live births, as is infant mortality at 43 deaths per 1000 live births. One in every 19 babies born in Uganda does not live to celebrate their first birthday. Many of these deaths occur within the first 28 days of life, forming the single largest category of death. Promising effects for preventing death are expected from timed and targeted counselling (ttC), an intervention package of key messages and actions that address integrated health and nutrition needs of the mothers and children, barriers and negotiation agreement, to cause sustainable behavioural change at specific timelines in the first 1000 days.
METHODS
The study has a quasi-experimental design in order to evaluate the implementation and effectiveness of the ttC intervention. Participants are pregnant women who have been registered by village health team (VHT) members and who live in Hoima (intervention region) or Masindi (control region) districts, who will be monitored throughout their pregnancy up to at least six weeks after delivery. A multi-stage sampling technique will be employed to select participants, the study sites being purposively chosen. Sample size is determined using the pregnancy rate from the population estimates, resulting in a total required sample of 1218 (609 each in the intervention and control group). Study instruments that will be used include the Ugandan VHT household register (in which all mothers to be studied will be registered), the ttC register (an additional tool for the study area), and a study questionnaire, to collect data at outcome level. Univariate, bivariate and multivariate analyses will be performed using SPSS to evaluate intervention effects on outcomes (e.g., relationship between pregnancy outcomes and antenatal attendance). In addition, quantitative findings will be triangulated with qualitative data, and collected through interviews and focus group discussions with participants and implementers.
DISCUSSION
The proposed study will examine the effectiveness of implementing ttC to improve maternal and child outcomes in Uganda. If ttC is effective, broader implementation of appropriate antenatal services can be advised as essential newborn care improvements.
TRIAL REGISTRATION
PACTR, PACTR202002812123868. Registered on 25 February 2020.",2020,"Promising effects for preventing death are expected from timed and targeted counselling (ttC), an intervention package of key messages and actions that address integrated health and nutrition needs of the mothers and children, barriers and negotiation agreement, to cause sustainable behavioural change at specific timelines in the first 1000 days.
","['Rural Uganda', 'Uganda', 'Participants are pregnant women who have been registered by village health team (VHT) members and who live in Hoima (intervention region) or Masindi (control region) districts, who will be monitored throughout their pregnancy up to at least six weeks after delivery']",['Implementing the Timed and Targeted Counselling Model'],['Pregnancy Outcomes and Newborn Survival'],"[{'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0829207,"Promising effects for preventing death are expected from timed and targeted counselling (ttC), an intervention package of key messages and actions that address integrated health and nutrition needs of the mothers and children, barriers and negotiation agreement, to cause sustainable behavioural change at specific timelines in the first 1000 days.
","[{'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Babughirana', 'Affiliation': 'Department of Health Promotion, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, 6211 LK Maastricht, The Netherlands.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Gerards', 'Affiliation': 'Department of Health Promotion, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, 6211 LK Maastricht, The Netherlands.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mokori', 'Affiliation': 'Independent Scholar, Kampala 7047, Uganda.'}, {'ForeName': 'Benon', 'Initials': 'B', 'LastName': 'Musasizi', 'Affiliation': 'World Vision International, Hoima 5319, Uganda.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Isabirye', 'Affiliation': 'School of Public Health, Makerere University, Kampala 7062, Uganda.'}, {'ForeName': 'Isaac Charles', 'Initials': 'IC', 'LastName': 'Baigereza', 'Affiliation': 'World Vision International, Hoima 5319, Uganda.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Rukanda', 'Affiliation': 'Lutheran World Federation, Hoima 5827, Uganda.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Bussaja', 'Affiliation': 'Mulago National Referral Hospital, Kampala 7051, Uganda.'}, {'ForeName': 'Stef', 'Initials': 'S', 'LastName': 'Kremers', 'Affiliation': 'Department of Health Promotion, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, 6211 LK Maastricht, The Netherlands.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gubbels', 'Affiliation': 'Department of Health Promotion, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, 6211 LK Maastricht, The Netherlands.'}]",Methods and protocols,['10.3390/mps3040073']
1776,33138109,"Hands-On Times, Adherence to Recommendations and Variance in Execution among Three Different CPR Algorithms: A Prospective Randomized Single-Blind Simulator-Based Trial.","BACKGROUND
Alternative cardiopulmonary resuscitation (CPR) algorithms, introduced to improve outcomes after cardiac arrest, have so far not been compared in randomized trials with established CPR guidelines.
METHODS
286 physician teams were confronted with simulated cardiac arrests and randomly allocated to one of three versions of a CPR algorithm: (1) current International Liaison Committee on Resuscitation (ILCOR) guidelines (""ILCOR""), (2) the cardiocerebral resuscitation (""CCR"") protocol (3 cycles of 200 uninterrupted chest compressions with no ventilation), or (3) a local interpretation of the current guidelines (""Arnsberg"", immediate insertion of a supraglottic airway and cycles of 200 uninterrupted chest compressions). The primary endpoint was percentage of hands-on time.
RESULTS
Median percentage of hands-on time was 88 (interquartile range (IQR) 6) in ""ILCOR"" teams, 90 (IQR 5) in ""CCR"" teams ( p = 0.001 vs. ""ILCOR""), and 89 (IQR 4) in ""Arnsberg"" teams ( p = 0.032 vs. ""ILCOR""; p = 0.10 vs. ""CCR""). ""ILCOR"" teams delivered fewer chest compressions and deviated more from allocated targets than ""CCR"" and ""Arnsberg"" teams. ""CCR"" teams demonstrated the least within-team and between-team variance.
CONCLUSIONS
Compared to current ILCOR guidelines, two alternative CPR algorithms advocating cycles of uninterrupted chest compressions resulted in very similar hands-on times, fewer deviations from targets, and less within-team and between-team variance in execution.",2020,"""ILCOR"" teams delivered fewer chest compressions and deviated more from allocated targets than ""CCR"" and ""Arnsberg"" teams.","['286 physician teams were confronted with simulated cardiac arrests', 'Hands']","['cardiocerebral resuscitation (""CCR"") protocol (3 cycles of 200 uninterrupted chest compressions with no ventilation), or (3) a local interpretation of the current guidelines (""Arnsberg"", immediate insertion of a supraglottic airway and cycles of 200 uninterrupted chest compressions', 'CPR algorithm']","['percentage of hands-on time', 'Median percentage of hands-on time']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C1955905', 'cui_str': 'CCR Receptors'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",286.0,0.0894029,"""ILCOR"" teams delivered fewer chest compressions and deviated more from allocated targets than ""CCR"" and ""Arnsberg"" teams.","[{'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Rifai', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Bethesda Hospital, 47053 Duisburg, Germany.'}, {'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Sellmann', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Bethesda Hospital, 47053 Duisburg, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Wetzchewald', 'Affiliation': 'Institution for Emergency Medicine, 59755 Arnsberg, Germany.'}, {'ForeName': 'Heidrun', 'Initials': 'H', 'LastName': 'Schwager', 'Affiliation': 'Institution for Emergency Medicine, 59755 Arnsberg, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Tschan', 'Affiliation': 'Department of Psychology, University of Neuchatel, 2000 Neuchâtel, Switzerland.'}, {'ForeName': 'Sebastian G', 'Initials': 'SG', 'LastName': 'Russo', 'Affiliation': 'Department of Anaesthesiology, University of Witten/Herdecke, 58448 Witten, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Marsch', 'Affiliation': 'Department of Intensive Care, University Hospital, 4031 Basel, Switzerland.'}]",International journal of environmental research and public health,['10.3390/ijerph17217946']
1777,33138203,Sleep Health Promotion in the Workplace.,"Poor sleep and sleepiness in the workplace are associated with accidents. A workplace sleep health promotion program was implemented in an Italian police unit. Of the 242 police officers in the unit, 218 (90%) agreed to take part in the program. A crossover trial was made in which the police officers were divided into two groups that performed sleep health promotion activities in the first and second year, respectively. The first group of officers showed significant sleep improvements at the end of the first year, while the second group had similar or worse parameters than at baseline. At follow-up, a significant improvement in the quantity and quality of sleep was reported in both groups. Sleep improvements at follow-up were associated with a marked reduction in the frequency of accidents at work and near-misses. Before the intervention, sleepiness was the best predictor of injuries (aOR 1.220; CI95% 1.044-1.426) and near-misses (aOR 1.382; CI95% 1.182-1.615). At follow-up, when sleep conditions had improved, insomnia symptoms were the most significant predictors of work accidents (aOR 13.358; CI95% 2.353-75.818). Sleep health promotion can be useful in police officers.",2020,Sleep improvements at follow-up were associated with a marked reduction in the frequency of accidents at work and near-misses.,"['242 police officers in the unit, 218 (90%) agreed to take part in the program']",[],"['Poor sleep and sleepiness', 'quantity and quality of sleep', 'sleep improvements', 'insomnia symptoms', 'Sleep improvements']","[{'cui': 'C0086825', 'cui_str': 'Policeman'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],"[{'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0102323,Sleep improvements at follow-up were associated with a marked reduction in the frequency of accidents at work and near-misses.,"[{'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Garbarino', 'Affiliation': 'Post-Graduate School of Occupational Medicine, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Tripepi', 'Affiliation': 'Research Unit of Reggio Calabria, Institute of Clinical Physiology, Italian National Research Council, 89124 Calabria, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Magnavita', 'Affiliation': 'Post-Graduate School of Occupational Medicine, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17217952']
1778,33138210,Impact on Dietary Intake of Two Levels of Technology-Assisted Personalized Nutrition: A Randomized Trial.,"Advances in web and mobile technologies have created efficiencies relating to collection, analysis and interpretation of dietary intake data. This study compared the impact of two levels of nutrition support: (1) low personalization, comprising a web-based personalized nutrition feedback report generated using the Australian Eating Survey ® (AES) food frequency questionnaire data; and (2) high personalization, involving structured video calls with a dietitian using the AES report plus dietary self-monitoring with text message feedback. Intake was measured at baseline and 12 weeks using the AES and diet quality using the Australian Recommended Food Score (ARFS). Fifty participants (aged 39.2 ± 12.5 years; Body Mass Index 26.4 ± 6.0 kg/m 2 ; 86.0% female) completed baseline measures. Significant ( p < 0.05) between-group differences in dietary changes favored the high personalization group for total ARFS (5.6 points (95% CI 1.3 to 10.0)) and ARFS sub-scales of meat (0.9 points (0.4 to 1.6)), vegetarian alternatives (0.8 points (0.1 to 1.4)), and dairy (1.3 points (0.3 to 2.3)). Additional significant changes in favor of the high personalization group occurred for proportion of energy intake derived from energy-dense, nutrient-poor foods (-7.2% (-13.8% to -0.5%)) and takeaway foods sub-group (-3.4% (-6.5% to 0.3%). Significant within-group changes were observed for 12 dietary variables in the high personalization group vs one variable for low personalization. A higher level of personalized support combining the AES report with one-on-one dietitian video calls and dietary self-monitoring resulted in greater dietary change compared to the AES report alone. These findings suggest nutrition-related web and mobile technologies in combination with personalized dietitian delivered advice have a greater impact compared to when used alone.",2020,"Significant ( p < 0.05) between-group differences in dietary changes favored the high personalization group for total ARFS (5.6 points (95% CI 1.3 to 10.0)) and ARFS sub-scales of meat (0.9 points (0.4 to 1.6)), vegetarian alternatives (0.8 points (0.1 to 1.4)), and dairy (1.3 points (0.3 to 2.3)).",['Fifty participants (aged 39.2\u2009±\u200912.5 years; Body Mass Index 26.4\u2009±\u20096.0 kg/m 2 ; 86.0% female'],"['nutrition support: (1) low personalization, comprising a web-based personalized nutrition feedback report generated using the Australian Eating Survey ® (AES) food frequency questionnaire data; and (2) high personalization, involving structured video calls with a dietitian using the AES report plus dietary self-monitoring with text message feedback', 'Technology-Assisted Personalized Nutrition']","['ARFS sub-scales of meat', 'proportion of energy intake', 'total ARFS', 'dietary changes']","[{'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0882079,"Significant ( p < 0.05) between-group differences in dietary changes favored the high personalization group for total ARFS (5.6 points (95% CI 1.3 to 10.0)) and ARFS sub-scales of meat (0.9 points (0.4 to 1.6)), vegetarian alternatives (0.8 points (0.1 to 1.4)), and dairy (1.3 points (0.3 to 2.3)).","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Rollo', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Haslam', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, Callaghan, NSW 2308, Australia.'}]",Nutrients,['10.3390/nu12113334']
1779,33138479,Portable Automated Rapid Testing (PART) for auditory assessment: Validation in a young adult normal-hearing population.,"This study aims to determine the degree to which Portable Automated Rapid Testing (PART), a freely available program running on a tablet computer, is capable of reproducing standard laboratory results. Undergraduate students were assigned to one of three within-subject conditions that examined repeatability of performance on a battery of psychoacoustical tests of temporal fine structure processing, spectro-temporal amplitude modulation, and targets in competition. The repeatability condition examined test/retest with the same system, the headphones condition examined the effects of varying headphones (passive and active noise-attenuating), and the noise condition examined repeatability in the presence of recorded cafeteria noise. In general, performance on the test battery showed high repeatability, even across manipulated conditions, and was similar to that reported in the literature. These data serve as validation that suprathreshold psychoacoustical tests can be made accessible to run on consumer-grade hardware and perform in less controlled settings. This dataset also provides a distribution of thresholds that can be used as a normative baseline against which auditory dysfunction can be identified in future work.",2020,"In general, performance on the test battery showed high repeatability, even across manipulated conditions, and was similar to that reported in the literature.","['Undergraduate students', 'young adult normal-hearing population']",['Portable Automated Rapid Testing (PART'],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0234725', 'cui_str': 'Hearing normal'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",[],,0.0171383,"In general, performance on the test battery showed high repeatability, even across manipulated conditions, and was similar to that reported in the literature.","[{'ForeName': 'E Sebastian', 'Initials': 'ES', 'LastName': 'Lelo de Larrea-Mancera', 'Affiliation': 'Psychology Department, University of California, Riverside, 900 University Avenue, Riverside, California 92521, USA.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Stavropoulos', 'Affiliation': 'Brain Game Center, University of California Riverside, 1201 University Avenue, Riverside California 92521, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Hoover', 'Affiliation': 'University of Maryland, College Park, Maryland 20742, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Eddins', 'Affiliation': 'University of South Florida, Tampa, Florida 33620, USA.'}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Gallun', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon 97239, USA.'}, {'ForeName': 'Aaron R', 'Initials': 'AR', 'LastName': 'Seitz', 'Affiliation': 'Psychology Department, University of California, Riverside, 900 University Avenue, Riverside, California 92521, USA.'}]",The Journal of the Acoustical Society of America,['10.1121/10.0002108']
1780,33138628,Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety.,"Background: The VOYAGER PAD trial demonstrated superiority of rivaroxaban plus aspirin versus aspirin to reduce major cardiac and ischemic limb events following lower extremity revascularization (LER). Clopidogrel is commonly used as a short-term adjunct to aspirin after endovascular revascularization, whether clopidogrel modifies the efficacy and safety of rivaroxaban has not been described. Methods: VOYAGER PAD was a phase 3, international, double-blind, placebo-controlled trial in symptomatic PAD patients undergoing LER randomized to rivaroxaban 2.5 mg twice daily plus 100 mg aspirin daily or rivaroxaban placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke or cardiovascular death. The principal safety endpoint was TIMI major bleeding with ISTH major bleeding a secondary safety outcome. Clopidogrel use was allowed at the discretion of the investigator for up to six months following the qualifying revascularization. Results: 3313 (50.6%) of the randomized patients received clopidogrel, median duration of 29.0 days. Over 3-years the hazard ratio (HR) for the primary outcome of rivaroxaban versus placebo was 0.85 (95% CI 0.71-1.01) with clopidogrel and 0.86 (95% CI 0.73-1.01) without, without statistical heterogeneity (p-interaction =0.92). Rivaroxaban resulted in an early apparent reduction in acute limb ischemia (ALI) within 30 days, HR 0.45 (95%CI 0.14-1.46) with and HR 0.48 (95% CI 0.22-1.01) without clopidogrel (p-interaction = 0.93). Compared with aspirin, rivaroxaban increased TIMI major bleeding similarly regardless of clopidogrel use (p-interaction 0.71). With clopidogrel use >30 days, rivaroxaban was associated with more ISTH major bleeding within 365 days (HR 3.20, 95% CI 1.44-7.13) compared with shorter durations of clopidogrel (p-trend 0.06). Conclusions: In the VOYAGER PAD trial, rivaroxaban plus aspirin reduced the risk of adverse cardiovascular and limb events with an early benefit for ALI regardless of clopidogrel use. The safety of rivaroxaban was consistent regardless of clopidogrel use, but with a trend for more ISTH major bleeding with clopidogrel use > 30 days than a shorter duration. These data support the addition of rivaroxaban to aspirin after LER regardless of concomitant clopidogrel with a short (course ≤ 30 days) associated with less bleeding. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT02504216.",2020,"Compared with aspirin, rivaroxaban increased TIMI major bleeding similarly regardless of clopidogrel use (p-interaction 0.71).","['lower extremity revascularization (LER', 'Peripheral Artery Disease Lower Extremity Revascularization', 'symptomatic PAD patients undergoing LER randomized to']","['rivaroxaban', 'rivaroxaban plus aspirin versus aspirin', 'Clopidogrel', 'Rivaroxaban', 'rivaroxaban plus aspirin', 'Rivaroxaban and Aspirin', 'placebo', 'clopidogrel', 'aspirin, rivaroxaban', 'aspirin daily or rivaroxaban placebo plus aspirin']","['TIMI major bleeding with ISTH major bleeding a secondary safety outcome', 'risk of adverse cardiovascular and limb events', 'major cardiac and ischemic limb events', 'composite of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke or cardiovascular death', 'Efficacy and Safety', 'ISTH major bleeding', 'TIMI major bleeding', 'hazard ratio (HR', 'acute limb ischemia (ALI', 'bleeding']","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C4049535', 'cui_str': 'Acute limb ischaemia'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.550696,"Compared with aspirin, rivaroxaban increased TIMI major bleeding similarly regardless of clopidogrel use (p-interaction 0.71).","[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'CPC Clinical Research, Aurora, CO; University of Colorado School of Medicine, Division of Cardiology, Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'CPC Clinical Research, Aurora, CO; University of Colorado School of Medicine, Division of Cardiology, Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nehler', 'Affiliation': 'CPC Clinical Research, Aurora, CO; University of Colorado School of Medicine, Department of Surgery, Aurora, CO.'}, {'ForeName': 'Eike Sebastian', 'Initials': 'ES', 'LastName': 'Debus', 'Affiliation': 'Department of Vascular Medicine, Vascular Surgery - Angiology - Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sonia S', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Warren H', 'Initials': 'WH', 'LastName': 'Capell', 'Affiliation': 'CPC Clinical Research, Aurora, CO; Department of Medicine, Division of Endocrinology, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Brackin', 'Affiliation': 'CPC Clinical Research, Aurora, CO.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Jaeger', 'Affiliation': 'CPC Clinical Research, Aurora, CO.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Hess', 'Affiliation': 'CPC Clinical Research, Aurora, CO; University of Colorado School of Medicine, Division of Cardiology, Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Akos F', 'Initials': 'AF', 'LastName': 'Pap', 'Affiliation': 'Bayer AG, Research & Development, Wuppertal, Germany.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer US LLC, Whippany, NJ.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Muehlhofer', 'Affiliation': 'Bayer AG, Research & Development, Wuppertal, Germany.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Haskell', 'Affiliation': 'Janssen Research and Development, Raritan, NJ.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brasil', 'Affiliation': 'FELUMA - Faculdade de Ciencias Medicas de Minas Gerais School of Medicine, Belo Horizonte, Brasil.'}, {'ForeName': 'Juraj', 'Initials': 'J', 'LastName': 'Madaric', 'Affiliation': 'Department of Angiology, Comenius University and National Cardiovascular Institute, Bratislava, Slovakia.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Sillesen', 'Affiliation': 'Dept. of Vascular Surgery, Rigshospitalet, Institute of Clinical Medicine, University of Copenhagen, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Szalay', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Bauersachs', 'Affiliation': 'Department of Vascular Medicine, Klinikum Darmstadt GmbH, Darmstadt, Germany.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.050465']
1781,33138837,"Report on planning comparison of VMAT, IMRT and helical tomotherapy for the ESCALOX-trial pre-study.","BACKGROUND
The ESCALOX trial was designed as a multicenter, randomized prospective dose escalation study for head and neck cancer. Therefore, feasibility of treatment planning via different treatment planning systems (TPS) and radiotherapy (RT) techniques is essential. We hypothesized the comparability of dose distributions for simultaneous integrated boost (SIB) volumes respecting the constraints by different TPS and RT techniques.
METHODS
CT data sets of the first six patients (all male, mean age: 61.3 years) of the pre-study (up to 77 Gy) were used for comparison of IMRT, VMAT, and helical tomotherapy (HT). Oropharynx was the primary tumor location. Normalization of the three step SIB (77 Gy, 70 Gy, 56 Gy) was D95% = 77 Gy. Coverage (CVF), healthy tissue conformity index (HTCI), conformation number (CN), and dose homogeneity (HI) were compared for PTVs and conformation index (COIN) for parotids.
RESULTS
All RT techniques achieved good coverage. For SIB77Gy, CVF was best for IMRT and VMAT, HT achieved highest CN followed by VMAT and IMRT. HT reached good HTCI value, and HI compared to both other techniques. For SIB70Gy, CVF was best by IMRT. HTCI favored HT, consequently CN as well. HI was slightly better for HT. For SIB56Gy, CVF resulted comparably. Conformity favors VMAT as seen by HTCI and CN. Dmean of ipsilateral and contralateral parotids favor HT.
CONCLUSION
Different TPS for dose escalation reliably achieved high plan quality. Despite the very good results of HT planning for coverage, conformity, and homogeneity, the TPS also achieved acceptable results for IMRT and VMAT. Trial registration ClinicalTrials.gov Identifier: NCT01212354, EudraCT-No.: 2010-021139-15. ARO: ARO 14-01.",2020,"Despite the very good results of HT planning for coverage, conformity, and homogeneity, the TPS also achieved acceptable results for IMRT and VMAT.","['CT data sets of the first six patients (all male, mean age: 61.3\xa0years) of the pre-study (up to 77\xa0Gy', 'head and neck cancer']","['treatment planning via different treatment planning systems (TPS) and radiotherapy (RT) techniques', 'VMAT, IMRT and helical tomotherapy', 'IMRT, VMAT, and helical tomotherapy (HT']","['Coverage (CVF), healthy tissue conformity index (HTCI), conformation number (CN), and dose homogeneity (HI']","[{'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3489631', 'cui_str': 'Intensity-Modulated Arc Therapy'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C1831735', 'cui_str': 'Helical Tomotherapies'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026377', 'cui_str': 'Molecular conformation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.0258713,"Despite the very good results of HT planning for coverage, conformity, and homogeneity, the TPS also achieved acceptable results for IMRT and VMAT.","[{'ForeName': 'Steffi U', 'Initials': 'SU', 'LastName': 'Pigorsch', 'Affiliation': 'Department of Radiation Oncology, Technical University of Munich (TUM), School of Medicine, Klinikum Rechts Der Isar, Ismaninger Straße 22, 81675, Munich, Germany. steffi.pigorsch@tum.de.'}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Kampfer', 'Affiliation': 'Department of Radiation Oncology, Technical University of Munich (TUM), School of Medicine, Klinikum Rechts Der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Oechsner', 'Affiliation': 'Department of Radiation Oncology, Technical University of Munich (TUM), School of Medicine, Klinikum Rechts Der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Mayinger', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, Rämistrasse 100, Zurich, Switzerland.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Mozes', 'Affiliation': 'Department of Radiation Oncology, Technical University of Munich (TUM), School of Medicine, Klinikum Rechts Der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Devecka', 'Affiliation': 'Department of Radiation Oncology, Technical University of Munich (TUM), School of Medicine, Klinikum Rechts Der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Kerstin K', 'Initials': 'KK', 'LastName': 'Kessel', 'Affiliation': 'Department of Radiation Oncology, Technical University of Munich (TUM), School of Medicine, Klinikum Rechts Der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Combs', 'Affiliation': 'Department of Radiation Oncology, Technical University of Munich (TUM), School of Medicine, Klinikum Rechts Der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Wilkens', 'Affiliation': 'Department of Radiation Oncology, Technical University of Munich (TUM), School of Medicine, Klinikum Rechts Der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01693-2']
1782,33138838,Preoperative planning by osteotomy master software helps to improve the accuracy of target limb alignment in high tibial osteotomy.,"BACKGROUND
The accuracy of targeted lower limb alignment correction following HTO is closely related to patients' pain relief and knee joint survival time. How to accurately perform osteotomy and how to obtain the ideal target limb alignment to maximize the curative effect are the difficulty in HTO practice. The purpose of this study is to evaluate the predictive and application value of osteotomy master software (OsteoMaster) in coronal plane preoperative planning of high tibial osteotomy.
METHOD
Sixty-seven patients with medial compartment osteoarthritis and varus deformity treated by medial open-weight high tibial osteotomy were enrolled and divided into observation group (31 cases) and control group (36 cases). The observation group was planned by OsteoMaster, while the control group was planned by Miniaci. The preoperative predicted values of osteotomy depth, open height, correction angle, WBL ratio, and FTA of the observation group were compared with the actual intraoperative values to study their accuracy. The operative time, blood loss, number of fluoroscopy, and WBL ratio were compared between the observation group and the control group to study its application value.
RESULT
There was no significant difference between two groups in preoperative prediction and intraoperative reality of osteotomy depth, open height, correction angle, FTA, and WBL ratio (P > 0.05). The operation time and number of fluoroscopy in the observation group were significantly less than those in the control group (P < 0.05), while the difference in blood loss was not statistically significant (P > 0.05). The good rate of WBL ratio was 87.1% in the observation group and 75% in the control group.
CONCLUSION
OsteoMaster has predictive value in osteotomy depth, open height, correction angle, FTA, and WBL ratio of HTO, which is also helpful to reduce the number of fluoroscopy, shorten the operation time, and improve the accuracy of target limb alignment. The drawback of this approach is 2-dimensional approach in contrast to 3-dimensional preoperative planning that is including the more real study.",2020,"There was no significant difference between two groups in preoperative prediction and intraoperative reality of osteotomy depth, open height, correction angle, FTA, and WBL ratio (P > 0.05).",['Sixty-seven patients with medial compartment osteoarthritis and varus deformity treated by medial open-weight high tibial osteotomy'],['osteotomy master software (OsteoMaster'],"['operation time and number of fluoroscopy', 'osteotomy depth, open height, correction angle, WBL ratio, and FTA', 'preoperative prediction and intraoperative reality of osteotomy depth, open height, correction angle, FTA, and WBL ratio', 'pain relief and knee joint survival time', 'good rate of WBL ratio', 'blood loss', 'operative time, blood loss, number of fluoroscopy, and WBL ratio']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0432593', 'cui_str': 'Varus angulation'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0948775', 'cui_str': 'High weight'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}]","[{'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0016384', 'cui_str': 'Flutamide'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",67.0,0.0176676,"There was no significant difference between two groups in preoperative prediction and intraoperative reality of osteotomy depth, open height, correction angle, FTA, and WBL ratio (P > 0.05).","[{'ForeName': 'Axiang', 'Initials': 'A', 'LastName': 'He', 'Affiliation': ""Department of Joint Surgery, Shanghai No. 6 People's Hospital East Campus, Shanghai Health Medical College, Shanghai, China.""}, {'ForeName': 'Yanjie', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': ""Department of Joint Surgery, Shanghai No. 6 People's Hospital East Campus, Shanghai Health Medical College, Shanghai, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Joint Surgery, Shanghai No. 6 People's Hospital East Campus, Shanghai Health Medical College, Shanghai, China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Kong', 'Affiliation': ""Department of Joint Surgery, Shanghai No. 6 People's Hospital East Campus, Shanghai Jiao Tong University, No. 222, West Huanhu Third Road, Pudong New Area, Shanghai, 201306, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Joint Surgery, Shanghai No. 6 People's Hospital East Campus, Shanghai Health Medical College, Shanghai, China.""}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Joint Surgery, Shanghai No. 6 People's Hospital East Campus, Shanghai Health Medical College, Shanghai, China.""}, {'ForeName': 'Wanjun', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Joint Surgery, Shanghai No. 6 People's Hospital East Campus, Shanghai Health Medical College, Shanghai, China. 775230296@qq.com.""}, {'ForeName': 'Xianlong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Joint Surgery, Shanghai No. 6 People's Hospital East Campus, Shanghai Jiao Tong University, No. 222, West Huanhu Third Road, Pudong New Area, Shanghai, 201306, China. 18701966075@139.com.""}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-02033-6']
1783,33138848,Salivary and Nasal Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses (BBCovid): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES
- To describe the evolution of the SARS-CoV-2 salivary viral load of patients infected with Covid-19, performing 7 days of tri-daily mouthwashes with and without antivirals. - To compare the evolution of the SARS-CoV-2 nasal and salivary viral load according to the presence or absence of antivirals in the mouthwash.
TRIAL DESIGN
This is a multi-center, randomised controlled trial (RCT) with two parallel arms (1:1 ratio).
PARTICIPANTS
Inclusion criteria - Age: 18-85 years old - Clinical diagnosis of Covid-19 infection - Clinical signs have been present for less than 8 days - Virological confirmation - Understanding and acceptance of the trial - Written agreement to participate in the trial Exclusion criteria - Pregnancy, breastfeeding, inability to comply with protocol, lack of written agreement - Patients using mouthwash on a regular basis (more than once a week) - Patient at risk of infectious endocarditis - Patients unable to answer questions - Uncooperative patient The clinical trial is being conducted with the collaboration of three French hospital centers: Hospital Center Emile Roux (Le Puy en Velay, France), Clinic of the Protestant Infirmary (Lyon, France) and Intercommunal Hospital Center (Mont de Marsan, France).
INTERVENTION AND COMPARATOR
Eligible participants will be allocated to one of the two study groups. Intervention group: patients perform a tri-daily mouthwash with mouthwash containing antivirals (β-cyclodextrin and Citrox®) for a period of 7 days.
CONTROL GROUP
patients perform a tri-daily mouthwash with a placebo mouthwash for a period of 7 days.
MAIN OUTCOMES
Primary Outcome Measures: Change from Baseline amount of SARS-CoV-2 in salivary samples at 4 and 9 hours, 1, 2, 3, 4, 5 and 6 days. Real-time PCR assays are performed to assess salivary SARS-CoV 2 viral load.
SECONDARY OUTCOME MEASURES
Change from Baseline amount of SARS-CoV-2 virus in nasal samples at 6 days. Real-time PCR assays are performed to assess nasal SARS-CoV-2 viral load.
RANDOMISATION
Participants meeting all eligibility requirements are allocated to one of the two study arms (mouthwash with β-cyclodextrin and Citrox® or mouthwash without β-cyclodextrin and Citrox®) in a 1:1 ratio using simple randomisation with computer generated random numbers.
BLINDING (MASKING)
Participants, doctors and nurses caring for participants, laboratory technicians and investigators assessing the outcomes will be blinded to group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
Both the intervention and control groups will be composed of 103 participants, so the study will include a total of 206 participants.
TRIAL STATUS
The current protocol version is 6, August 4 th , 2020. Recruitment began on April 6, 2020 and is anticipated to be complete by April 5, 2021. As of October 2, 2020, forty-two participants have been included.
TRIAL REGISTRATION
This trial was registered on 20 April 2020 at www.clinicaltrials.gov with the number NCT04352959 .
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol."" The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).""",2020,"To describe the evolution of the SARS-CoV-2 salivary viral load of patients infected with Covid-19, performing 7 days of tri-daily mouthwashes with and without antivirals.","['20 April 2020 at www.clinicaltrials.gov with the number NCT04352959 ', '103 participants, so the study will include a total of 206 participants', '\n\n\nParticipants, doctors and nurses caring for participants, laboratory technicians and investigators assessing the outcomes', 'Inclusion criteria - Age: 18-85 years old - Clinical diagnosis of Covid-19 infection - Clinical signs have been present for less than 8 days - Virological confirmation - Understanding and acceptance of the trial - Written agreement to participate in the trial Exclusion criteria - Pregnancy, breastfeeding, inability to comply with protocol, lack of written agreement - Patients using mouthwash on a regular basis (more than once a week) - Patient at risk of infectious endocarditis - Patients unable to answer questions - Uncooperative patient The clinical trial is being conducted with the collaboration of three French hospital centers: Hospital Center Emile Roux (Le Puy en Velay, France), Clinic of the Protestant Infirmary (Lyon, France) and Intercommunal Hospital Center (Mont de Marsan, France', 'As of October 2, 2020, forty-two participants have been included']","['tri-daily mouthwash with mouthwash containing antivirals (β-cyclodextrin and Citrox®', 'Antiviral Mouthrinses (BBCovid', 'β-cyclodextrin and Citrox® or mouthwash without β-cyclodextrin and Citrox®']","['SARS-CoV-2 virus in nasal samples', 'Salivary and Nasal Detection of the SARS-CoV-2 Virus', 'Change from Baseline amount of SARS-CoV-2 in salivary samples']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0086517', 'cui_str': 'Laboratory technician'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0275521', 'cui_str': 'Clinical infection'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0014122', 'cui_str': 'Subacute bacterial endocarditis'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C0424350', 'cui_str': 'Uncooperative behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0242220', 'cui_str': 'Protestant, follower of religion'}, {'cui': 'C4319566', 'cui_str': '42'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0010558', 'cui_str': 'Cyclodextrins'}]","[{'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",206.0,0.305351,"To describe the evolution of the SARS-CoV-2 salivary viral load of patients infected with Covid-19, performing 7 days of tri-daily mouthwashes with and without antivirals.","[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Carrouel', 'Affiliation': 'University of Lyon, University Claude Bernard Lyon 1, Laboratory ""Systemic Health Care"", EA4129, 69008, Lyon, France. florence.carrouel@univ-lyon1.fr.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Viennot', 'Affiliation': 'University of Lyon, University Claude Bernard Lyon 1, Laboratory ""Systemic Health Care"", EA4129, 69008, Lyon, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Valette', 'Affiliation': 'National Reference Center for Respiratory Viruses, Department of Virology, Infective Agents Institute, North Hospital Network, Lyon, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'Open Rome (Organize and Promote Epidemiological Network), Paris, France.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Dussart', 'Affiliation': 'University of Lyon, University Claude Bernard Lyon 1, Laboratory ""Systemic Health Care"", EA4129, 69008, Lyon, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Bourgeois', 'Affiliation': 'University of Lyon, University Claude Bernard Lyon 1, Laboratory ""Systemic Health Care"", EA4129, 69008, Lyon, France.'}]",Trials,['10.1186/s13063-020-04846-6']
1784,33138867,Hyperimmune anti-COVID-19 IVIG (C-IVIG) Therapy for Passive Immunization of Severe and Critically Ill COVID-19 Patients: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES
The aim of this trial is to investigate the safety and clinical efficacy of passive immunization therapy through Hyperimmune anti-COVID-19 Intravenous Immunoglobulin (C-IVIG: 5% liquid formulation), on severe and critically ill patients with COVID-19.
TRIAL DESIGN
This is a phase I/II single centre, randomised controlled, single-blinded, superiority trial, through parallel-group design with sequential assignment. Participants will be randomised either to receive both C-IVIG and standard care or only standard care (4:1).
PARTICIPANTS
The study is mono-centric with the participants including COVID19 infected individuals (positive SARS-CoV-2 PCR on nasopharyngeal and/or oropharyngeal swabs) admitted in institute affiliated with Dow University Hospital, Dow University of Health Sciences, Karachi, Pakistan. Consenting patients above 18 years that are classified by the treating physician as severely ill i.e. showing symptoms of COVID-19 pneumonia; dyspnea, respiratory rate ≥30/min, blood oxygen saturation ≤93%, PaO 2 /FiO 2 <300, and lung infiltrates >50% on CXR; or critically ill i.e. respiratory failure, septic shock, and multiple organ dysfunction or failure. Patients with reported IgA deficiency, autoimmune disorder, thromboembolic disorder, and allergic reaction to immunoglobulin treatment were excluded from study. Similarly, pregnant females, patients requiring two or more inotropic agents to maintain blood pressure and patients with acute or chronic kidney injury/failure, were also excluded from the study.
INTERVENTION AND COMPARATOR
The study consists of four interventions and one comparator arm. All participants receive standard hospital care which includes airway support, anti-viral medication, antibiotics, fluid resuscitation, hemodynamic support, steroids, painkillers, and anti-pyretics. Randomised test patients will receive single dose of C-IVIG in following four dosage groups: Group 1: 0.15g/Kg with standard hospital care Group 2: 0.2g/Kg with standard hospital care Group 3: 0.25g/Kg with standard hospital care Group 4: 0.3g/Kg with standard hospital care Group 5 (comparator) will receive standard hospital care only MAIN OUTCOMES: The primary outcomes are assessment and follow-up of participants to observe 28-day mortality and, • the level and duration of assisted ventilation during hospital stay, • number of days to step down (shifting from ICU to isolation ward), • number of days to hospital discharge, • adverse events (Kidney failure, hypersensitivity with cutaneous or hemodynamic manifestations, aseptic meningitis, hemolytic anemia, leuko-neutropenia, transfusion related acute lung injury (TRALI)) during hospital stay, • change in C-Reactive Protein (CRP) levels, • change in neutrophil lymphocyte ratio to monitor inflammation.
RANDOMISATION
Consenting participants who fulfill the criteria are allocated to either intervention or comparator arm with a ratio of 4:1, using sequentially numbered opaque sealed envelope simple randomization method. The participant allocated for intervention will be sequentially assigned dosage group 1-4 in ascending order. Participants will not be recruited in the next dosage group before a set number of participants in one group (10) are achieved.
BLINDING (MASKING)
Single blinded study, with participants blinded to allocation.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
Total 50 patients are randomised. The intervention arms consist of 40 participants divided in four groups of 10 participants while the comparator group consists of 10 patients.
TRIAL STATUS
Current version of the protocol is ""Version 2"" dated 29 th September, 2020. Participants are being recruited. Recruitment started on June, 2020 and is estimated to primarily end on January, 2021.
TRIAL REGISTRATION
This trial was registered at ClinicalTrials.gov, NCT04521309 on 20 August 2020 and is retrospectively registered.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).",2020,"Participants will be randomised either to receive both C-IVIG and standard care or only standard care (4:1).
","['Severe and Critically Ill COVID-19 Patients', 'Consenting patients above 18 years that are classified by the treating physician as severely ill i.e. showing symptoms of COVID-19 pneumonia; dyspnea, respiratory rate ≥30/min, blood oxygen saturation ≤93%, PaO 2 /FiO 2 <300, and lung infiltrates >50% on CXR; or critically ill i.e. respiratory failure, septic shock, and multiple organ dysfunction or failure', 'Patients with reported IgA deficiency, autoimmune disorder, thromboembolic disorder, and allergic reaction to immunoglobulin treatment were excluded from study', '20 August 2020 and is retrospectively registered', 'participants including COVID19 infected individuals (positive SARS-CoV-2 PCR on nasopharyngeal and/or oropharyngeal swabs) admitted in institute affiliated with Dow University Hospital, Dow University of Health Sciences, Karachi, Pakistan', 'critically ill patients with COVID-19', 'Total 50 patients are randomised', '40 participants divided in four groups of 10 participants while the comparator group consists of 10 patients', 'pregnant females, patients requiring two or more inotropic agents to maintain blood pressure and patients with acute or chronic kidney injury/failure, were also excluded from the study']","['passive immunization therapy', 'Hyperimmune anti-COVID-19 Intravenous Immunoglobulin', 'standard hospital care Group 2: 0.2g/Kg with standard hospital care Group 3', 'Hyperimmune anti-COVID-19 IVIG (C-IVIG) Therapy', 'C-IVIG and standard care or only standard care (4:1', 'standard hospital care which includes airway support, anti-viral medication, antibiotics, fluid resuscitation, hemodynamic support, steroids, painkillers, and anti-pyretics']","['safety and clinical efficacy', 'assessment and follow-up of participants to observe 28-day mortality and, •', 'level and duration of assisted ventilation during hospital stay, • number of days to step down (shifting from ICU to isolation ward), • number of days to hospital discharge, • adverse events (Kidney failure, hypersensitivity with cutaneous or hemodynamic manifestations, aseptic meningitis, hemolytic anemia, leuko-neutropenia, transfusion related acute lung injury (TRALI)) during hospital stay, • change in C-Reactive Protein (CRP) levels, • change in neutrophil lymphocyte ratio to monitor inflammation']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0006888', 'cui_str': 'Christmas Island'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0162538', 'cui_str': 'Immunoglobulin A deficiency'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0304509', 'cui_str': 'Inotropic agent'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}]","[{'cui': 'C0020974', 'cui_str': 'Passive immunization'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0025290', 'cui_str': 'Aseptic meningitis'}, {'cui': 'C0002878', 'cui_str': 'Hemolytic anemia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0948343', 'cui_str': 'Acute lung injury during and following administration of blood product'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",40.0,0.211031,"Participants will be randomised either to receive both C-IVIG and standard care or only standard care (4:1).
","[{'ForeName': 'Shaukat', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan. ali.shaukat@duhs.edu.pk.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Luxmi', 'Affiliation': 'Dow University Hospital, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Anjum', 'Affiliation': 'Dow Research Institute of Biotechnology and Biomedical Sciences, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Sheikh Muhammad', 'Initials': 'SM', 'LastName': 'Muhaymin', 'Affiliation': 'Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Syed Muneeb', 'Initials': 'SM', 'LastName': 'Uddin', 'Affiliation': 'Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Mir Rashid', 'Initials': 'MR', 'LastName': 'Ali', 'Affiliation': 'Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Sohaib', 'Initials': 'S', 'LastName': 'Tauheed', 'Affiliation': 'Dow International Medical College, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Mujtaba', 'Initials': 'M', 'LastName': 'Khan', 'Affiliation': 'Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Bajwa', 'Affiliation': 'Dow University Hospital, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Saif Ullah', 'Initials': 'SU', 'LastName': 'Baig', 'Affiliation': 'Dow University Hospital, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Elisha', 'Initials': 'E', 'LastName': 'Shalim', 'Affiliation': 'Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Iqra', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Dow College of Biotechnology, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Abdul Samad', 'Initials': 'AS', 'LastName': 'Khan', 'Affiliation': 'National Control Laboratory for Biologicals, Islamabad, Pakistan.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Quraishy', 'Affiliation': 'Dow University of Health Sciences, Karachi, Pakistan.'}]",Trials,['10.1186/s13063-020-04839-5']
1785,33138970,"Letter to the editor regarding, ""Preemptive analgesia with a single low dose of intrathecal morphine in multilevel posterior lumbar interbody fusion surgery: a double-blind, randomized, controlled trial,"" by Wang et al.",,2020,,['multilevel posterior lumbar interbody fusion surgery'],['intrathecal morphine'],[],"[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",[],,0.513244,,"[{'ForeName': 'Ze-Qing', 'Initials': 'ZQ', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesia, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, No. 44 Xiaoheyan Road, Dadong District, Shenyang 110000, Liaoning Province, China. Electronic address: icquk26@163.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesia, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, No. 44 Xiaoheyan Road, Dadong District, Shenyang 110000, Liaoning Province, China.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.06.007']
1786,33139269,Randomised comparison of postpolypectomy surveillance intervals following a two-round baseline colonoscopy: the Japan Polyp Study Workgroup.,"OBJECTIVE
To assess whether follow-up colonoscopy after polypectomy at 3 years only, or at 1 and 3 years would effectively detect advanced neoplasia (AN), including nonpolypoid colorectal neoplasms (NP-CRNs).
DESIGN
A prospective multicentre randomised controlled trial was conducted in 11 Japanese institutions. The enrolled participants underwent a two-round baseline colonoscopy (interval: 1 year) to remove all neoplastic lesions. Subsequently, they were randomly assigned to undergo follow-up colonoscopy at 1 and 3 years (2-examination group) or at 3 years only (1-examination group). The incidence of AN, defined as lesions with low-grade dysplasia ≥10 mm, high-grade dysplasia or invasive cancer, at follow-up colonoscopy was evaluated.
RESULTS
A total of 3926 patients were enrolled in this study. The mean age was 57.3 (range: 40-69) years, and 2440 (62%) were male. Of these, 2166 patients were assigned to two groups (2-examination: 1087, 1-examination: 1079). Overall, we detected 29 AN in 28 patients at follow-up colonoscopy in both groups. On per-protocol analysis (701 in 2-examination vs 763 in 1-examination group), the incidence of AN was similar between the two groups (1.7% vs 2.1%, p=0.599). The results of the non-inferiority test were significant (p=0.017 in per-protocol, p=0.001 in intention-to-treat analysis). NP-CRNs composed of dominantly of the detected AN (62%, 18/29), and most of them were classified into laterally spreading tumour non-granular type (83%, 15/18).
CONCLUSION
After a two-round baseline colonoscopy, follow-up colonoscopy at 3 years detected AN, including NP-CRNs, as effectively as follow-up colonoscopies performed after 1 and 3 years.",2020,"The results of the non-inferiority test were significant (p=0.017 in per-protocol, p=0.001 in intention-to-treat analysis).","['11 Japanese institutions', 'The mean age was 57.3 (range: 40-69) years, and 2440 (62%) were male', 'A total of 3926 patients were enrolled in this study', '2166 patients were assigned to two groups (2-examination: 1087, 1-examination: 1079']",['postpolypectomy surveillance intervals'],['incidence of AN'],"[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]",3926.0,0.11657,"The results of the non-inferiority test were significant (p=0.017 in per-protocol, p=0.001 in intention-to-treat analysis).","[{'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Matsuda', 'Affiliation': 'Cancer Screening Center, National Cancer Center Hospital, Tokyo, Japan tamatsud@ncc.go.jp.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'TF Clinic, Tokyo, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sano', 'Affiliation': 'Gastrointestinal Center and Institute of Minimally Invasive Endoscopic Care (iMEC), Sano Hospital, Kobe, Hyogo, Japan.'}, {'ForeName': 'Shin-Ei', 'Initials': 'SE', 'LastName': 'Kudo', 'Affiliation': 'Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Oda', 'Affiliation': 'Oda GI Endoscopy and Gastroenterology Clinic, Kumamoto, Japan.'}, {'ForeName': 'Kinichi', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Division of Endoscopy, Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan.'}, {'ForeName': 'Tadakazu', 'Initials': 'T', 'LastName': 'Shimoda', 'Affiliation': 'Division of Pathology, Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology, Tochigi Cancer Center, Utsunomiya, Tochigi, Japan.'}, {'ForeName': 'Masau', 'Initials': 'M', 'LastName': 'Sekiguchi', 'Affiliation': 'Cancer Screening Center, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Konishi', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Ikematsu', 'Affiliation': 'Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Iishi', 'Affiliation': 'Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Igarashi', 'Affiliation': 'Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Kiyonori', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology, Kitasato University East Hospital, Sagamihara, Kanagawa, Japan.'}, {'ForeName': 'Miwa', 'Initials': 'M', 'LastName': 'Sada', 'Affiliation': 'Department of Gastroenterology, Kitasato University East Hospital, Sagamihara, Kanagawa, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Endoscopy, Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan.'}, {'ForeName': 'Kiwamu', 'Initials': 'K', 'LastName': 'Hasuda', 'Affiliation': 'Hattori GI Endoscopy and Gastroenterology Clinic, Kumamoto, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Shinohara', 'Affiliation': 'Department of Gastroenterology, Saku Central Hospital Advanced Care Center, Saku, Nagano, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Molecular-Targeting Cancer Prevention, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Murakami', 'Affiliation': 'Department of Medical Statistics, Toho University, Tokyo, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Pathology and Clinical Laboratory Division, JR Tokyo General Hospital, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Fujimori', 'Affiliation': 'Department of Pathology, Shinko Hospital, Kobe, Hyogo, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Ajioka', 'Affiliation': 'Division of Molecular and Diagnostic Pathology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Shigeaki', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Aomori Prefectural Central Hospital, Aomori, Japan.'}]",Gut,['10.1136/gutjnl-2020-321996']
1787,33139313,Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: qualitative study of parents' and health professionals' views and experiences.,"BACKGROUND
More effective recruitment strategies like alternative approaches to consent are needed to facilitate adequately powered trials. Witholding Enteral feeds Around Transfusion was a multicentre, randomised, pilot trial that compared withholding and continuing feeds around transfusion. The primary clinical outcome was necrotising enterocolitis. The trial used simplified opt-out consent with concise parent information and no consent form.
OBJECTIVE
To explore the views and experiences of parents and health professionals on the acceptability and feasibility of opt-out consent in randomised comparative effectiveness trials.
METHODS
A qualitative, descriptive interview-based study nested within a randomised trial. Semistructured interview transcripts were analysed using inductive thematic analysis.
SETTING
Eleven neonatal units in England.
PARTICIPANTS
Eleven parents and ten health professionals with experience of simplified consent.
RESULTS
Five themes emerged: 'opt-out consent operationalised as verbal opt-in consent', 'opt-out consent normalises participation while preserving parental choice', 'opt-out consent as an ongoing process of informed choice', 'consent without a consent form' and 'choosing to opt out of a comparative effectiveness trial', with two subthemes: 'wanting ""normal care""' and 'a belief that feeding is better'.
CONCLUSION
Introducing a novel form of consent proved challenging in practice. The principle of a simplified, opt-out approach to consent was generally considered feasible and acceptable by health professionals for a neonatal comparative effectiveness trial. The priority for parents was having the right to decide about trial participation, and they did not see opt-out consent as undermining this. Describing a study as 'opt-out' can help to normalise participation and emphasise that parents can withdraw consent.",2020,"The priority for parents was having the right to decide about trial participation, and they did not see opt-out consent as undermining this.","['Eleven parents and ten health professionals with experience of simplified consent', 'Eleven neonatal units in England', ""parents' and health professionals' views and experiences""]",[],['necrotising enterocolitis'],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0449911', 'cui_str': 'View'}]",[],"[{'cui': 'C0014356', 'cui_str': 'Enterocolitis'}]",11.0,0.074032,"The priority for parents was having the right to decide about trial participation, and they did not see opt-out consent as undermining this.","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'McLeish', 'Affiliation': 'Nuffield Department of Population Health, National Perinatal Epidemiology Unit, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Alderdice', 'Affiliation': 'Nuffield Department of Population Health, National Perinatal Epidemiology Unit, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Robberts', 'Affiliation': 'Bliss, Maya House, London, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Cole', 'Affiliation': 'Nuffield Department of Population Health, National Perinatal Epidemiology Unit, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Dorling', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gale', 'Affiliation': 'Academic Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK christopher.gale@imperial.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2020-319545']
1788,33139537,Antibody-mediated activation of the FGFR1/Klothoβ complex corrects metabolic dysfunction and alters food preference in obese humans.,"Fibroblast growth factor 21 (FGF21) controls metabolic organ homeostasis and eating/drinking behavior via FGF receptor 1/Klothoβ (FGFR1/KLB) complexes expressed in adipocytes, pancreatic acinar cells, and the nervous system in mice. Chronic administration of recombinant FGF21 or engineered variants improves metabolic health in rodents, nonhuman primates, and humans; however, the rapid turnover of these molecules limits therapeutic utility. Here we show that the bispecific anti-FGFR1/KLB agonist antibody BFKB8488A induced marked weight loss in obese cynomolgus monkeys while elevating serum adiponectin and the adipose expression of FGFR1 target genes, demonstrating its action as an FGF21 mimetic. In a randomized, placebo-controlled, single ascending-dose study in overweight/obese human participants, subcutaneous BFKB8488A injection caused transient body weight reduction, sustained improvement in cardiometabolic parameters, and a trend toward reduction in preference for sweet taste and carbohydrate intake. These data suggest that specific activation of the FGFR1/KLB complex in humans can be used as therapy for obesity-related metabolic defects.",2020,Fibroblast growth factor 21 (FGF21) controls metabolic organ homeostasis and eating/drinking behavior via FGF receptor 1/Klothoβ,"['obese humans', 'overweight/obese human participants']","['subcutaneous BFKB8488A injection', 'placebo', 'FGFR1/Klothoβ complex', 'recombinant FGF21', 'bispecific anti-FGFR1/KLB agonist antibody BFKB8488A']","['metabolic health', 'marked weight loss', 'Fibroblast growth factor 21 (FGF21) controls metabolic organ homeostasis and eating/drinking behavior via FGF receptor 1/Klothoβ']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0060369', 'cui_str': 'Fibroblast Growth Factor Receptors'}]",,0.0201048,Fibroblast growth factor 21 (FGF21) controls metabolic organ homeostasis and eating/drinking behavior via FGF receptor 1/Klothoβ,"[{'ForeName': 'Amos', 'Initials': 'A', 'LastName': 'Baruch', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Chin', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Leslie W', 'Initials': 'LW', 'LastName': 'Chinn', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Vaze', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Junichiro', 'Initials': 'J', 'LastName': 'Sonoda', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gelzleichter', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lewin-Koh', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Morrow', 'Affiliation': 'ProSciento, Inc., Chula Vista, CA 91911.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Dheerendra', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Boismenu', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Gutierrez', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wakshull', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Wilson', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Puneet S', 'Initials': 'PS', 'LastName': 'Arora', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080; puneetarora.md@gmail.com.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2012073117']
1789,33139636,"The Combination of a Diversified Intake of Carbohydrates and Fats and Supplementation of Vitamin D in a Diet Does Not Affect the Levels of Hormones (Testosterone, Estradiol, and Cortisol) in Men Practicing Strength Training for the Duration of 12 Weeks.","This study aims to verify the extent to which a diversification of carbohydrates and fats intake in a diet, together with the reduction in vitamin D deficiency, impact the levels of hormones (testosterone, estradiol, cortisol) and Sex Hormone Binding Globulin (SHGB) in men doing strength training. The research involved 55 men aged 19-35. The participants were divided into two groups following two interventional diets for 12 weeks: high-fat diet (LCHF) or high-carb diet (LFHC), which were applied to satisfy the caloric requirements of each participant. Moreover, vitamin D supplementation was included. Moreover, both before and after following interventional diets, the level of hormones in participant's blood was examined. After 12 weeks of following interventional diets in both groups, no changes of the levels of testosterone and estradiol, as well as SHGB, were found. The cortisol level in both groups decreased; however, only in the LFHC group was the change statistically significant ( p = 0.03) and amounted to -3.5% (the cortisol level on an empty stomach in this group decreased from 14.17 ± 3.35 to 13.93 ± 2.63 mcg/dl). In both groups, the supplementation of vitamin D brought about a significant change in the level of vitamin D metabolite (25 (OH) D) ( p = 0.01). In the LCHF group, the level of metabolite increased by 95%, and by 58.3% in the LFHC group. The increase in vitamin D metabolite in blood was higher in the LCHF group than the LFHC group, which might have resulted from the supplementation of this vitamin.",2020,"After 12 weeks of following interventional diets in both groups, no changes of the levels of testosterone and estradiol, as well as SHGB, were found.","['55 men aged 19-35', 'Men Practicing Strength Training for the Duration of 12 Weeks', 'men doing strength training']","['vitamin D supplementation', 'LCHF', 'Carbohydrates and Fats and Supplementation of Vitamin D', 'high-fat diet (LCHF) or high-carb diet (LFHC', 'LFHC']","['level of vitamin D metabolite (25 (OH) D', 'levels of testosterone and estradiol', 'levels of hormones (testosterone, estradiol, cortisol) and Sex Hormone Binding Globulin (SHGB', 'level of metabolite', 'vitamin D metabolite in blood', 'cortisol level', 'Levels of Hormones (Testosterone, Estradiol, and Cortisol']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0521974', 'cui_str': 'High fat diet'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",55.0,0.0206133,"After 12 weeks of following interventional diets in both groups, no changes of the levels of testosterone and estradiol, as well as SHGB, were found.","[{'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Wrzosek', 'Affiliation': 'Department of Dietetics, Instutute of Human Nutrition Sciences, Warsaw University of Life Sciences (WULS-SGGW), Nowoursynowska 159 C, 02-776 Warsaw, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Woźniak', 'Affiliation': 'Department of Dietetics, Instutute of Human Nutrition Sciences, Warsaw University of Life Sciences (WULS-SGGW), Nowoursynowska 159 C, 02-776 Warsaw, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Włodarek', 'Affiliation': 'Department of Dietetics, Instutute of Human Nutrition Sciences, Warsaw University of Life Sciences (WULS-SGGW), Nowoursynowska 159 C, 02-776 Warsaw, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17218057']
1790,33139686,Efficacy of an exercise program combined with lifestyle education in patients with knee osteoarthritis.,"Therapeutic exercise and lifestyle changes (LS) are usually recommended for the treatment of knee osteoarthritis (OA).
OBJECTIVES
to compare the impact of an exercise program vs. exercise program plus LS education in individuals with knee OA.
MATERIALS AND METHODS
Single-blind randomized clinical trial with individuals of both sexes with clinical and radiological diagnosis of knee OA. Participants received the treatment 2 times/week for 8 weeks. Therapeutic exercise involved warm-up, flexibility, muscle strengthening, balance and proprioception. The exercise plus lifestyle education group (ELG) also participated in 8 sessions of lectures and discussion on disease self-management and healthy LS. Participants were assessed for pain intensity (visual analog scale), lifestyle, symptoms and physical disability (WOMAC) and pressure pain tolerance threshold (PPT).
RESULTS
Sample consisted of 39 participants, divided into exercise group (EG, n=17) and ELG (n=22). Groups were homogeneous regarding regarding age, weight, height, initial pain perception (VAS) and gender predominance age and body mass index. After the interventions, reduction in pain perception and increase in PPT was observed in both groups. Despite the improvement in LS of both groups, only ELG exhibited a significant reduction in pain assessed by WOMAC. Therapeutic exercise programs may produce pain relief, but no improvements were observed in joint stiffness and funcionality.",2020,"Despite the improvement in LS of both groups, only ELG exhibited a significant reduction in pain assessed by WOMAC.","['individuals with knee OA', 'individuals of both sexes with clinical and radiological diagnosis of knee OA', 'patients with knee osteoarthritis']","['Therapeutic exercise and lifestyle changes (LS', 'ELG', 'exercise program vs. exercise program plus LS education', 'exercise program combined with lifestyle education', 'Therapeutic exercise programs', 'exercise plus lifestyle education group (ELG) also participated in 8 sessions of lectures and discussion on disease self-management and healthy LS']","['pain intensity (visual analog scale), lifestyle, symptoms and physical disability (WOMAC) and pressure pain tolerance threshold (PPT', 'pain perception and increase in PPT', 'pain assessed by WOMAC', 'pain relief', 'Therapeutic exercise involved warm-up, flexibility, muscle strengthening, balance and proprioception']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0677038', 'cui_str': 'Increase in pressure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]",39.0,0.0237079,"Despite the improvement in LS of both groups, only ELG exhibited a significant reduction in pain assessed by WOMAC.","[{'ForeName': 'Fábio Marcon', 'Initials': 'FM', 'LastName': 'Alfieri', 'Affiliation': 'Adventist University of Sao Paulo e University of Sao Paulo.'}, {'ForeName': 'Alessandra Rodrigues Souto', 'Initials': 'ARS', 'LastName': 'Lima', 'Affiliation': 'Adventist University of Sao Paulo.'}, {'ForeName': 'Marcia Maria Hernandes de Abreu de Oliveira', 'Initials': 'MMHAO', 'LastName': 'Salgueiro', 'Affiliation': 'Adventist University of Sao Paulo.'}, {'ForeName': 'Elisabete Agrela de', 'Initials': 'EA', 'LastName': 'Andrade', 'Affiliation': 'Adventist University of Sao Paulo.'}, {'ForeName': 'Linamara Rizzo', 'Initials': 'LR', 'LastName': 'Battistella', 'Affiliation': 'University of Sao Paulo.'}, {'ForeName': 'Natália Cristina de Oliveira Vargas E', 'Initials': 'NCOVE', 'LastName': 'Silva', 'Affiliation': 'Adventist University of Sao Paulo.'}]",Acta reumatologica portuguesa,[]
1791,33143507,"Long-term migration of a cementless stem with different bioactive coatings. Data from a ""prime"" RSA study: lessons learned.","Background and purpose - Little is known about the long-term migration pattern of cementless stems in total hip arthroplasty (THA). Furthermore, the role of bioactive coatings in fixation, and thus migration, remains uncertain. Hydroxyapatite (HA) is the most commonly used bioactive coating. However, delamination of the coating might induce loosening. Alternatively, fluorapatite (FA) has proved to be more thermostable than HA, thereby potentially increasing longevity. We assessed the long-term migration of cementless stems with different coatings using radiostereometric analysis (RSA), thereby establishing a reference for acceptable migration. Patients and methods - 61 THAs in 53 patients were randomized to receive either a HA, FA, or uncoated Mallory-Head Porous stem during the years 1992 to 1994. Primary outcome was stem migration measured using RSA and secondary outcome was the Harris Hip Score (HHS). Evaluation took place preoperatively and postoperatively on the second day, at 6, 12, 25 and 52 weeks, and annually thereafter. At the 25-year follow-up, 12 patients (17 THAs) had died and 1 patient (1 THA) was lost to follow-up. Due to the high number of missing second-day postoperative RSA radiographs, the 1-year postoperative RSA radiograph was used as baseline for the comparative analyses. Results - Mean follow-up was 17 years (SD 6.6). All stems showed initial rapid migration with median subsidence of 0.2 mm (-0.1 to 0.6) and median retroversion of 0.9° (-3.2 to 2) at 12 months, followed by stable migration reaching a plateau phase. No stem was revised, albeit 1 stem showed continuous subsidence up to 1.5 mm. Comparing the different coatings, we could not find a statistically significant difference in overall 25-year migration (p-values > 0.05). Median subsidence at 15-year follow-up was for HA -0.1 mm (-0.4 to 0.2), for FA 0 mm (-0.1 to 0.2), and for uncoated stems 0.2 mm (-0.1 to 0.5). Median internal rotation at 15-year follow-up was for HA not available, for FA 1.1° (-0.5 to 2.6), and for uncoated stems 0° (-0.5 to 0.4). HHS were also comparable (p-values > 0.05), with at 15-year follow-up for HA 85 points (41-99), for FA 76 points (61-90), and for uncoated stems 79 points (74-90). Interpretation - The long-term migration pattern of cementless stems using different bioactive coatings has not previously been described. No beneficial effect, or side effect at long-term follow-up of bioactive coatings, was found. The provided migration data can be used in future research to establish thresholds for acceptable migration patterns cementless stem designs.",2020,"Comparing the different coatings, we could not find a statistically significant difference in overall 25-year migration (p-values > 0.05).","['Patients and methods - 61 THAs in 53 patients', 'total hip arthroplasty (THA']","['HA, FA, or uncoated Mallory-Head Porous stem', 'cementless stem with different bioactive coatings', 'fluorapatite (FA', 'Hydroxyapatite (HA']","['overall 25-year migration', 'stem migration measured using RSA and secondary outcome was the Harris Hip Score (HHS', 'HHS', 'Median subsidence', 'Median internal rotation', 'median retroversion', '1-year postoperative RSA radiograph']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039245', 'cui_str': 'Tacrine'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0060515', 'cui_str': 'fluorapatite'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0041711', 'cui_str': 'United States. Dept. of Health and Human Services'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0333055', 'cui_str': 'Retroversion'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]",53.0,0.0571559,"Comparing the different coatings, we could not find a statistically significant difference in overall 25-year migration (p-values > 0.05).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van Der Voort', 'Affiliation': 'Department of Orthopaedics, Leiden University Medical Center, Leiden.'}, {'ForeName': 'Martijn L', 'Initials': 'ML', 'LastName': 'D Klein Nulent', 'Affiliation': 'Department of Orthopaedics, Leiden University Medical Center, Leiden.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Valstar', 'Affiliation': 'Department of Orthopaedics, Leiden University Medical Center, Leiden.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Kaptein', 'Affiliation': 'Department of Orthopaedics, Leiden University Medical Center, Leiden.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Fiocco', 'Affiliation': 'Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'G H H Nelissen', 'Affiliation': 'Department of Orthopaedics, Leiden University Medical Center, Leiden.'}]",Acta orthopaedica,['10.1080/17453674.2020.1840021']
1792,33143512,"Expression of concern: Comparison of myo-inositol and metformin on mental health parameters and biomarkers of oxidative stress in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial and The effects of fish oil omega-3 fatty acid supplementation on mental health parameters and metabolic status of patients with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.",,2020,,"['patients with polycystic ovary syndrome', 'women with polycystic ovary syndrome']","['fish oil omega-3 fatty acid supplementation', 'placebo', 'myo-inositol and metformin']","['mental health parameters and metabolic status', 'oxidative stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.761239,,[],Journal of psychosomatic obstetrics and gynaecology,['10.1080/0167482X.2020.1842508']
1793,33143532,Neural effects of a single dose of fluoxetine on resting-state functional connectivity in adolescent depression.,"Fluoxetine is commonly prescribed in adolescent depression, but the neural mechanisms underlying its action remain poorly understood. Here, we used resting-state functional magnetic resonance imaging to investigate the effects of a single dose of fluoxetine vs. placebo in adolescents with major depressive disorder. In contrast with previous studies in adults that have demonstrated an acute effect of antidepressants on activity within the default mode network, a single dose of fluoxetine did not alter activity in this network in adolescent depression. There were unexpected group activity differences in the motor network, which should be clarified in future research.",2020,"There were unexpected group activity differences in the motor network, which should be clarified in future research.","['adolescents with major depressive disorder', 'adolescent depression']","['fluoxetine', 'Fluoxetine', 'fluoxetine vs. placebo']",['resting-state functional connectivity'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0367822,"There were unexpected group activity differences in the motor network, which should be clarified in future research.","[{'ForeName': 'Liliana P', 'Initials': 'LP', 'LastName': 'Capitão', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chapman', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Filippini', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susannah E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'James', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Phil J', 'Initials': 'PJ', 'LastName': 'Cowen', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120959608']
1794,33143538,Does anxiety moderate the effectiveness of mirtazapine in patients with treatment-resistant depression? A secondary analysis of the MIR trial.,"BACKGROUND
There is a lack of evidence to guide treatment of comorbid depression and anxiety. Preliminary evidence suggests mirtazapine may be effective in treating patients with both depression and anxiety symptoms.
METHODS
We undertook a secondary analysis of mirtazapine (MIR): a placebo-controlled trial of the addition of mirtazapine to a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor in treatment-resistant depression (TRD) in primary care. We subdivided participants into three groups by baseline generalized anxiety disorder score (GAD-7): severe (GAD-7 ⩾ 16), moderate (GAD-7 = 11-15), no/mild (GAD-7 ⩽ 10). We used linear regression including likelihood-ratio testing of interaction terms to assess how baseline anxiety altered the response of participants to mirtazapine as measured by 12-week GAD-7 and Beck Depression Inventory II (BDI-II) scores.
RESULTS
Baseline generalized anxiety moderated mirtazapine's effect as measured by GAD-7 ( p = 0.041) and BDI-II ( p = 0.088) at 12 weeks. Participants with severe generalized anxiety receiving mirtazapine had lower 12-week GAD-7 score (adjusted difference between means (ADM) -2.82, 95% confidence interval (CI) -0.69 to -4.95) and larger decreases in BDI-II score (ADM -6.36, 95% CI -1.60 to -10.84) than placebo. Conversely, there was no anxiolytic benefit (ADM 0.28, 95% CI -1.05 to 1.60) or antidepressant benefit (ADM -0.17, 95% CI -3.02 to 2.68) compared with placebo in those with no/mild generalized anxiety.
CONCLUSIONS
These findings extend the evidence for the effectiveness of mirtazapine to reduce generalized anxiety in TRD in primary care. These results may inform targeted prescribing in depression based on concurrent anxiety symptoms, although these conclusions are constrained by the post-hoc nature of this analysis.",2020,"Conversely, there was no anxiolytic benefit (ADM 0.28, 95% CI -1.05 to 1.60) or antidepressant benefit (ADM -0.17, 95% CI -3.02 to 2.68) compared with placebo in those with no/mild generalized anxiety.
","['Participants with severe generalized anxiety receiving', 'GAD-7 ⩾ 16), moderate (GAD-7 = 11-15), no/mild (GAD-7 ⩽ 10', 'patients with both depression and anxiety symptoms', 'patients with treatment-resistant depression']","['mirtazapine (MIR', 'placebo', 'mirtazapine']","['generalized anxiety disorder score (GAD-7): severe', '12-week GAD-7 and Beck Depression Inventory II (BDI-II) scores', 'anxiolytic benefit', 'BDI-II score', 'GAD-7 score', 'generalized anxiety']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0049506', 'cui_str': 'Mirtazapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C4273555', 'cui_str': 'Beck Depression Inventory II score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.2179,"Conversely, there was no anxiolytic benefit (ADM 0.28, 95% CI -1.05 to 1.60) or antidepressant benefit (ADM -0.17, 95% CI -3.02 to 2.68) compared with placebo in those with no/mild generalized anxiety.
","[{'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Rifkin-Zybutz', 'Affiliation': 'Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'MacNeill', 'Affiliation': 'Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Simon Jc', 'Initials': 'SJ', 'LastName': 'Davies', 'Affiliation': 'Centre for Addiction and Mental Health, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Dickens', 'Affiliation': 'Mental Health Research Group, University of Exeter, Exeter, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Academic Primary Care, University of Exeter, Exeter, UK.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Anderson', 'Affiliation': 'Neuroscience and Psychiatry Unit, University of Manchester, Manchester, UK.'}, {'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Chew-Graham', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Wiles', 'Affiliation': 'Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120965939']
1795,33138708,Efficacy and Safety of Pharmacotherapeutic Smoking Cessation Aids in Schizophrenia Spectrum Disorders: Subgroup Analysis of EAGLES.,"OBJECTIVE
This study aimed to evaluate the efficacy and safety of varenicline, bupropion, and nicotine replacement therapy (NRT) among smokers with schizophrenia spectrum disorders in post hoc analyses of Evaluating Adverse Events in a Global Smoking Cessation Study data.
METHODS
Smokers with schizophrenia spectrum disorder (N=390) and without a psychiatric illness (control group, N=4,028) were randomly assigned to receive varenicline, bupropion, NRT patch, or placebo for 12 weeks. Outcomes included abstinence rates during treatment and follow-up, number needed to treat (NNT) for abstinence, incidence of neuropsychiatric adverse events (NPSAEs), and temporal relationship between NPSAEs and abstinence status.
RESULTS
Smokers with schizophrenia smoked more and had greater dependence and fewer prior trials of cessation pharmacotherapy at baseline. At each time point, smokers with schizophrenia assigned to varenicline had significantly greater odds of abstinence compared with their matched placebo group, with NNT comparable to the control group. Bupropion and NRT increased odds of abstinence; confidence intervals (CIs) included 1 for some comparisons, and NNT for smokers with schizophrenia was greater than for the control group. No treatment was associated with significantly more NPSAEs, compared with placebo, in either cohort. The estimated NPSAE rate was 5% (95% CI=3.0-7.7) for smokers with schizophrenia and 1% (95% CI=0.6-2.1) for the control group. Over one-third of NPSAEs occurred during partial or full abstinence, suggesting a multifactorial nature.
CONCLUSIONS
For smokers with schizophrenia, varenicline led to significantly higher abstinence rates, and NNT was comparable to the control group. A significant proportion of NPSAEs occurred during early abstinence. No treatment significantly increased NPSAE prevalence.",2020,"For smokers with schizophrenia, varenicline led to significantly higher abstinence rates, and NNT was comparable to the control group.","['Smokers with schizophrenia spectrum disorder (N=390) and without a psychiatric illness (control group, N=4,028', 'Schizophrenia Spectrum Disorders', 'smokers with schizophrenia spectrum disorders']","['varenicline', 'varenicline, bupropion, NRT patch, or placebo', 'Bupropion and NRT', 'placebo', 'varenicline, bupropion, and nicotine replacement therapy (NRT', 'Pharmacotherapeutic Smoking Cessation Aids']","['odds of abstinence', 'odds of abstinence; confidence intervals (CIs', 'efficacy and safety', 'abstinence rates during treatment and follow-up, number needed to treat (NNT) for abstinence, incidence of neuropsychiatric adverse events (NPSAEs), and temporal relationship between NPSAEs and abstinence status', 'proportion of NPSAEs', 'NPSAE prevalence', 'Efficacy and Safety', 'estimated NPSAE rate', 'abstinence rates, and NNT']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449235', 'cui_str': 'Temporal relationship'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",4028.0,0.11254,"For smokers with schizophrenia, varenicline led to significantly higher abstinence rates, and NNT was comparable to the control group.","[{'ForeName': 'A Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Russ', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lawrence', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McRae', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}, {'ForeName': 'Melissa Culhane', 'Initials': 'MC', 'LastName': 'Maravic', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}, {'ForeName': 'Jaimee L', 'Initials': 'JL', 'LastName': 'Heffner', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Anthenelli', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.202000032']
1796,33138738,Effectiveness of board game activities for reducing depression among older adults in adult day care centers of Taiwan: a quasi-experimental study.,"Depression is common in older adults and is associated with an increased risk of cognitive impairment. To clarify the possible roles of board game use in psychosomatic health promotion, this study evaluated the effects of board game activities in reducing depression in older adults. This was a quasi-experimental study. Purposive sampling was used to select 150 participants aged 65 years and above with intact mental functions who were currently residing in adult day care centers. Seventy-five participants who participated in 12 sessions of selected board game activities were assigned to the experimental group, and 75 participants who adhered to their ordinary activities were allocated to the control group. Structured questionnaires were used for data collection. The board game activities showed promising effects on the depression levels of the investigated older adults living in adult day care centers. Therefore, one possible beneficial effect of board game activities may be reduced depression in older adults. The results of this study provide support for the mediating role of board game activities in the mental health of long-term care elders. Incorporating board game activities into social work may help to make it more diverse and innovative.",2020,The board game activities showed promising effects on the depression levels of the investigated older adults living in adult day care centers.,"['older adults', 'older adults living in adult day care centers', 'mental health of long-term care elders', 'older adults in adult day care centers of Taiwan', 'Seventy-five participants who participated in 12 sessions of selected board game activities were assigned to the experimental group, and 75 participants who adhered to their ordinary activities', '150 participants aged 65\xa0years and above with intact mental functions who were currently residing in adult day care centers']",['board game activities'],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1161270', 'cui_str': 'Provision of adult day center care'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0563143', 'cui_str': 'Mental function'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}]",[],150.0,0.0407791,The board game activities showed promising effects on the depression levels of the investigated older adults living in adult day care centers.,"[{'ForeName': 'Bih-O', 'Initials': 'BO', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Kaohsiung Medical University , Kaohsiung, Taiwan.'}, {'ForeName': 'Ching-Teng', 'Initials': 'CT', 'LastName': 'Yao', 'Affiliation': 'Master Program of Long-Term Care in Aging, Kaohsiung Medical University , Kaohsiung, Taiwan.'}, {'ForeName': 'Chao-Fen', 'Initials': 'CF', 'LastName': 'Pan', 'Affiliation': 'Kaohsiung Medical University , Kaohsiung, Taiwan.'}]",Social work in health care,['10.1080/00981389.2020.1842576']
1797,33138740,Right To Play's intervention to reduce peer violence among children in public schools in Pakistan: a cluster-randomized controlled trial.,"BACKGROUND
Peer violence is common globally, but a little researched topic in low-and middle-income countries. This study presents the evaluation of a two-year randomized controlled trial of a structured play-based life-skills intervention implemented in schools in Hyderabad, Pakistan.
OBJECTIVE
To determine the impact of the intervention on school-based peer violence (victimization and perpetration) and depression among school children.
METHODS
40 single-sex public schools were randomized into two study arms (20 per arm 10 of each sex). A total of 1752 grade 6 students (929 from intervention and 823 from control schools) were enrolled in the trial. The two-year intervention was a biweekly structured game led by a coach followed by critical reflection and discussion for 30 minutes. Primary outcomes (exposure to peer violence exhibited through victimization and perpetration and depression) were evaluated using generalized linear-mixed models.
RESULTS
Of the enrolled children (N = 1752) 91% provided data for analysis. There were significant decreases in self-reported peer violence victimization, perpetration and depression. For peer violence victimization, the reductions in the intervention and control arms were: 33.3% versus 27.8% for boys and 58.5% versus 21.3% for girls. For peer violence perpetration, the reductions were: 25.3% versus 11.1% for boys and 55.6% versus 27.6% for girls in the intervention and control arms, respectively. There were significant drops in mean depression scores (boys 7.2% versus 4.8% intervention and control and girls 9.5% versus 5.6% intervention and control).
CONCLUSION
A well-designed and implemented play-based life-skills intervention delivered in public schools in Pakistan is able to effect a significant reduction in peer violence.",2020,"For peer violence perpetration, the reductions were: 25.3% versus 11.1% for boys and 55.6% versus 27.6% for girls in the intervention and control arms, respectively.","['40 single-sex public schools', 'children in public schools in Pakistan', 'Of the enrolled children (N\xa0', 'schools in Hyderabad, Pakistan', 'school children', 'A total of 1752 grade 6 students (929 from intervention and 823 from control schools']","['structured play-based life-skills intervention', 'biweekly structured game led by a coach followed by critical reflection and discussion for 30\xa0minutes']","['peer violence exhibited through victimization and perpetration and depression', 'mean depression scores', 'school-based peer violence (victimization and perpetration) and depression', 'self-reported peer violence victimization, perpetration and depression', 'peer violence']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",,0.076969,"For peer violence perpetration, the reductions were: 25.3% versus 11.1% for boys and 55.6% versus 27.6% for girls in the intervention and control arms, respectively.","[{'ForeName': 'Rozina', 'Initials': 'R', 'LastName': 'Karmaliani', 'Affiliation': 'School of Nursing and Midwifery, Aga Khan University , Karachi City, Pakistan.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'McFarlane', 'Affiliation': ""College of Nursing, Texas Woman's University , Denton, TX, USA.""}, {'ForeName': 'Hussain Maqbool Ahmed', 'Initials': 'HMA', 'LastName': 'Khuwaja', 'Affiliation': 'School of Nursing and Midwifery, Aga Khan University , Karachi City, Pakistan.'}, {'ForeName': 'Yasmeen', 'Initials': 'Y', 'LastName': 'Somani', 'Affiliation': 'School of Nursing and Midwifery, Aga Khan University , Karachi City, Pakistan.'}, {'ForeName': 'Shireen', 'Initials': 'S', 'LastName': 'Shehzad', 'Affiliation': 'School of Nursing and Midwifery, Aga Khan University , Karachi City, Pakistan.'}, {'ForeName': 'Tazeen', 'Initials': 'T', 'LastName': 'Saeed Ali', 'Affiliation': 'School of Nursing and Midwifery, Aga Khan University , Karachi City, Pakistan.'}, {'ForeName': 'Nargis', 'Initials': 'N', 'LastName': 'Asad', 'Affiliation': 'Department of Psychiatry, Aga Khan University , Karachi City, Pakistan.'}, {'ForeName': 'Esnat D', 'Initials': 'ED', 'LastName': 'Chirwa', 'Affiliation': 'Gender & Health Research Unit, South Africa Medical Research Council , Pretoria, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jewkes', 'Affiliation': 'Gender & Health Research Unit, South Africa Medical Research Council , Pretoria, South Africa.'}]",Global health action,['10.1080/16549716.2020.1836604']
1798,33139173,Effects of throat packs during orthognathic surgery: a double-blind randomized controlled clinical trial.,"Throat packs are commonly used in maxillofacial surgeries. However, the evidence to support the benefits of their use is controversial. The aim of this study was to evaluate the effectiveness of throat packs in preventing postoperative nausea and vomiting, and their influence on the incidence of sore throat and dysphagia in patients undergoing orthognathic surgery. This was a prospective double-blind randomized study with 54 patients, who were randomized to two groups: with throat pack (n=27) and without throat pack (n=27). Fifty patients (25 in each group) were included in the analysis; 66% female and 34% male, mean age 29.44±8.53 years. Postoperative nausea and vomiting (Kortilla scale), sore throat (visual analogue scale), and dysphagia were evaluated. Statistically significant differences in favour of the without-pack group were found for the variables throat pain at 24hours (P=0.002) and dysphagia at 2 hours (P=0.007) and 24 hours (P<0.001). There was no difference between the groups regarding postoperative nausea and vomiting (P=1.00). The results of this study indicate that throat packs as utilized here do not prevent postoperative nausea and vomiting and are associated with worse sore throats and postoperative dysphagia.",2020,There was no difference between the groups regarding postoperative nausea and vomiting (P=1.00).,"['54 patients', 'Fifty patients (25 in each group) were included in the analysis; 66% female and 34% male, mean age 29.44±8.53 years', 'patients undergoing orthognathic surgery']","['throat packs', 'orthognathic surgery', 'throat pack (n=27) and without throat pack']","['postoperative nausea and vomiting', 'Postoperative nausea and vomiting (Kortilla scale), sore throat (visual analogue scale), and dysphagia', 'sore throat and dysphagia', 'sore throats and postoperative dysphagia', 'variables throat pain', 'dysphagia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}]","[{'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0242429', 'cui_str': 'Pain in throat'}]",,0.387995,There was no difference between the groups regarding postoperative nausea and vomiting (P=1.00).,"[{'ForeName': 'T F', 'Initials': 'TF', 'LastName': 'Faro', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Oswaldo Cruz Hospital, University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'de Oliveira E Silva', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Oswaldo Cruz Hospital, University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Campos', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Oswaldo Cruz Hospital, University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Duarte', 'Affiliation': 'Department of Anaesthesiology, Pernambuco Federal University, Recife, Pernambuco, Brazil.'}, {'ForeName': 'A M M', 'Initials': 'AMM', 'LastName': 'Caetano', 'Affiliation': 'Department of Anaesthesiology, Pernambuco Federal University, Recife, Pernambuco, Brazil.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Laureano Filho', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Oswaldo Cruz Hospital, University of Pernambuco, Recife, Pernambuco, Brazil. Electronic address: laureano.filho@upe.br.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2020.05.020']
1799,33139234,A comparative study of the Parker Flex-Tip tube versus standard portex tube for oral fiberoptic intubation in bronchoscopy performed by pulmonologists with limited experience.,"BACKGROUND
Fiberoptic tracheal intubation (FTI) in bronchoscopy is widely performed with a conventional Portex tracheal tube (PTT). Occasionally, it is difficult for pulmonologists with limited experience to insert a tube beyond the vocal cords and advance it into the trachea. A new endotracheal tube, the Parker Flex-Tip tube (PFT), was recently designed. We compared the usefulness and safety of PFT versus PTT for FTI in bronchoscopy performed by pulmonologists with limited experience.
METHODS
Forty consecutive patients were enrolled and randomly assigned to either the PFT group (n = 20) or PTT group (n = 20). The time required for the tip of the endotracheal tube to pass from the mouth to the carina, the number of vomiting reflexes, the number of attempts to pass the tube through the vocal cords during intubation, complications, and technical difficulty of intubation were evaluated.
RESULTS
Both the PFT and PTT groups exhibited high intubation success rates (100% vs. 90%, respectively). The PFT group was intubated faster than the PTT group (11.5 [5-45] s vs. 22.5 [8-270] s, respectively, p < 0.01). The PFT group showed fewer vomiting reflexes and tube impingements than the PTT group (p < 0.05). Operators felt it was easier to intubate with PFT versus PTT (p < 0.01). Complications were not significantly different between the two groups.
CONCLUSION
For pulmonologists with limited experience who perform FTI in bronchoscopy, intubation using PFT versus PTT is faster and easier, without an increase in complications.",2020,"Both the PFT and PTT groups exhibited high intubation success rates (100% vs. 90%, respectively).",['Forty consecutive patients'],"['PFT versus PTT', 'Parker Flex-Tip tube (PFT', 'PFT', 'PTT', 'Parker Flex-Tip tube versus standard portex tube for oral fiberoptic intubation', 'conventional Portex tracheal tube (PTT', 'Fiberoptic tracheal intubation (FTI', 'PFT and PTT']","['vomiting reflexes and tube impingements', 'Complications', 'intubation success rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C1260970', 'cui_str': 'Tracheal tube'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",40.0,0.0246893,"Both the PFT and PTT groups exhibited high intubation success rates (100% vs. 90%, respectively).","[{'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Yamauchi', 'Affiliation': 'Division of Pulmonary Medicine, Department of Medicine, Jichi Medical University, Tochigi, Japan. Electronic address: yamauchi@jichi.ac.jp.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Division of Pulmonary Medicine, Department of Medicine, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Pulmonary Medicine, Department of Thoracic Surgery, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Sata', 'Affiliation': 'Division of Pulmonary Medicine, Department of Medicine, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Mato', 'Affiliation': 'Division of Pulmonary Medicine, Department of Medicine, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Bando', 'Affiliation': 'Division of Pulmonary Medicine, Department of Medicine, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hagiwara', 'Affiliation': 'Division of Pulmonary Medicine, Department of Medicine, Jichi Medical University, Tochigi, Japan.'}]",Respiratory investigation,['10.1016/j.resinv.2020.09.009']
1800,33139264,FDA Approval Summary: Atezolizumab plus bevacizumab for the treatment of patients with advanced unresectable or metastatic hepatocellular carcinoma.,"On May 29, 2020, the FDA approved atezolizumab for use in combination with bevacizumab, for the treatment of adult patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) with no prior systemic treatment. The approval was based on data from Study IMbrave150, which randomly allocated (2:1) patients to receive either atezolizumab plus bevacizumab (atezolizumab-bevacizumab) or sorafenib. Overall survival (OS) and independently-assessed progression free survival (PFS) in the intent-to-treat (ITT) population were the primary endpoints. At the time of the primary analysis, the estimated median OS could not be estimated in the atezolizumab-bevacizumab arm and was 13.2 months in the sorafenib arm (Hazard Ratio [HR]: 0.58; 95% Confidence Interval [CI]: 0.42, 0.79). The estimated median PFS was 6.8 months (95% CI: 5.8, 8.3) and 4.3 months (95% CI: 4.0, 5.6) in the atezolizumab-bevacizumab and sorafenib arms, respectively. Adverse reactions occurring in >20% of patients receiving atezolizumab-bevacizumab were hypertension, fatigue/asthenia, and proteinuria. Adverse reactions occurring in >20% of patients receiving sorafenib were palmar-plantar erythrodysesthesia, diarrhea, hypertension, and decreased appetite. Hemorrhage was reported more frequently in patients receiving atezolizumab-bevacizumab (25%) than in patients receiving sorafenib (17%). An evaluation for the presence of varices is recommended within 6 months of initiation of atezolizumab-bevacizumab in patients with HCC. Approval of atezolizumab-bevacizumab is likely to change the treatment paradigm for HCC given that treatment with atezolizumab-bevacizumab resulted in improved OS and PFS compared to sorafenib, an accepted standard of care for first-line treatment of patients with unresectable HCC.",2020,Hemorrhage was reported more frequently in patients receiving atezolizumab-bevacizumab (25%) than in patients receiving sorafenib (17%).,"['patients with unresectable HCC', 'patients with HCC', 'patients with advanced unresectable or metastatic hepatocellular carcinoma', 'adult patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) with no prior systemic treatment']","['atezolizumab plus bevacizumab (atezolizumab-bevacizumab) or sorafenib', 'atezolizumab-bevacizumab', 'bevacizumab', 'atezolizumab', 'Atezolizumab plus bevacizumab', 'sorafenib']","['estimated median OS', 'Hemorrhage', 'palmar-plantar erythrodysesthesia, diarrhea, hypertension, and decreased appetite', 'Overall survival (OS) and independently-assessed progression free survival (PFS', 'Adverse reactions', 'estimated median PFS', 'OS and PFS', 'hypertension, fatigue/asthenia, and proteinuria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0744869', 'cui_str': 'Metastatic hepatocellular carcinoma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}]",,0.105931,Hemorrhage was reported more frequently in patients receiving atezolizumab-bevacizumab (25%) than in patients receiving sorafenib (17%).,"[{'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Casak', 'Affiliation': 'Office of Oncologic Diseases, United States Food and Drug Administration sandra.casak@fda.hhs.gov.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Donoghue', 'Affiliation': 'Division of Biological Oncology Products, United States Food and Drug Administration.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Fashoyin-Aje', 'Affiliation': 'Office of Oncologic Diseases, United States Food and Drug Administration.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Office of Biostatistics, United States Food and Drug Administration.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rodriguez', 'Affiliation': 'Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration.'}, {'ForeName': 'Yuan Li', 'Initials': 'YL', 'LastName': 'Shen', 'Affiliation': 'Office of Biostatistics, United States Food and Drug Administration.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Center for Drug Evaluation and Research, United States Food and Drug Administration.'}, {'ForeName': 'Xiling', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Center for Drug Evaluation and Research, United States Food and Drug Administration.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'United States Food and Drug Administration.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Office of Clinical Pharmacology, Food and Drug Administration.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pierce', 'Affiliation': 'Office of Oncology Diseases, Food and Drug Administration.'}, {'ForeName': 'Shubhangi', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Center for Drug Evaluation and Research, United States Food and Drug Administration.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'Oncology Center of Excellence, United States Food and Drug Administration.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Theoret', 'Affiliation': 'Center for Drug Evaluation and Research, Food and Drug Administration.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Kluetz', 'Affiliation': 'Oncology Center of Excellence, Food and Drug Administration.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Office of Oncology Drug Products, United States Food and Drug Administration.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Lemery', 'Affiliation': 'Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-3407']
1801,33139266,Phase II study of Avelumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib.,"PURPOSE
This study investigated the efficacy and safety of avelumab, an anti-PD-L1 antibody, in patients with advanced hepatocellular carcinoma previously treated with sorafenib (NCT03389126).
EXPERIMENTAL DESIGN
This is a single-arm, single center, phase II trial. Patients with Child-Pugh A score who had at least one measurable lesion were enrolled. Intravenous avelumab 10 mg/kg every 2 weeks was given until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) according to RECIST v1.1. Secondary endpoints included time to progression (TTP), overall survival (OS), disease control rate (DCR), and safety.
RESULTS
A total of 30 patients were enrolled. After a median follow-up of 13.9 months, 27 progression events and 20 death events occurred. There was no complete response, 3 (10.0%) partial response, and 19 (63.3%) stable disease. ORR was 10.0% and DCR was 73.3%. The median TTP and OS was 4.4 and 14.2 months, respectively. PD-L1 expression did not affect avelumab response. Prior duration of sorafenib treatment, when dichotomized by the median 2.7 months, was associated with treatment outcome. TTP (6.5 vs. 1.8 months, p = 0.007) and OS (19.0 vs. 7.8 months, p = 0.006) were superior in patients with longer sorafenib duration. There was tendency of higher ORR (20.0% vs. 0.0%, p = 0.22) in those with longer sorafenib duration. Avelumab was well tolerated with 7 grade 3 adverse events and no grade 4 adverse events.
CONCLUSIONS
Avelumab showed moderate efficacy and was well tolerated in advanced hepatocellular carcinoma previously treated with sorafenib.",2020,"There was tendency of higher ORR (20.0% vs. 0.0%, p = 0.22) in those with longer sorafenib duration.","['patients with advanced hepatocellular carcinoma previously treated with', 'patients with longer sorafenib duration', '30 patients were enrolled', 'Pugh A score who had at least one measurable lesion were enrolled', 'Patients with Child', 'patients with advanced hepatocellular carcinoma previously treated with sorafenib (NCT03389126', 'advanced hepatocellular carcinoma']","['Intravenous avelumab', 'Avelumab', 'TTP', 'avelumab', 'sorafenib']","['objective response rate (ORR', 'median TTP and OS', 'PD-L1 expression', 'ORR', '27 progression events and 20 death events', 'moderate efficacy', 'higher ORR', 'time to progression (TTP), overall survival (OS), disease control rate (DCR), and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",30.0,0.0551694,"There was tendency of higher ORR (20.0% vs. 0.0%, p = 0.22) in those with longer sorafenib duration.","[{'ForeName': 'Dae-Won', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': 'Internal medicine, Seoul National University.'}, {'ForeName': 'Eun Ju', 'Initials': 'EJ', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Liver Research Institute, Seoul National University College of Medicine.'}, {'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Liver Research Institute, Seoul National University College of Medicine.'}, {'ForeName': 'Su Jong', 'Initials': 'SJ', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine, Liver Research Institute, Seoul National University College of Medicine.'}, {'ForeName': 'Yoon-Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Liver Research Institute, Seoul National University College of Medicine.'}, {'ForeName': 'Jung-Hwan', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine.'}, {'ForeName': 'Tae-Yong', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital.'}, {'ForeName': 'Sae-Won', 'Initials': 'SW', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Cancer Research Institute, Internal medicine, Seoul National University College of Medicine.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Cancer Research Institute, Seoul National University.'}, {'ForeName': 'Tae-You', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital.'}, {'ForeName': 'Youngeun', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Pathology, Seoul National University Hospital.'}, {'ForeName': 'Haeryoung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Pathology, Seoul National University Hospital.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine kyunghunlee@snu.ac.kr.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-3094']
1802,33139709,"Emotional face processing across neurodevelopmental disorders: a dynamic faces study in children with autism spectrum disorder, attention deficit hyperactivity disorder and obsessive-compulsive disorder.","Autism spectrum disorder (ASD) is classically associated with poor face processing skills, yet evidence suggests that those with obsessive-compulsive disorder (OCD) and attention deficit hyperactivity disorder (ADHD) also have difficulties understanding emotions. We determined the neural underpinnings of dynamic emotional face processing across these three clinical paediatric groups, including developmental trajectories, compared with typically developing (TD) controls. We studied 279 children, 5-19 years of age but 57 were excluded due to excessive motion in fMRI, leaving 222: 87 ASD, 44 ADHD, 42 OCD and 49 TD. Groups were sex- and age-matched. Dynamic faces (happy, angry) and dynamic flowers were presented in 18 pseudo-randomized blocks while fMRI data were collected with a 3T MRI. Group-by-age interactions and group difference contrasts were analysed for the faces vs. flowers and between happy and angry faces. TD children demonstrated different activity patterns across the four contrasts; these patterns were more limited and distinct for the NDDs. Processing happy and angry faces compared to flowers yielded similar activation in occipital regions in the NDDs compared to TDs. Processing happy compared to angry faces showed an age by group interaction in the superior frontal gyrus, increasing with age for ASD and OCD, decreasing for TDs. Children with ASD, ADHD and OCD differentiated less between dynamic faces and dynamic flowers, with most of the effects seen in the occipital and temporal regions, suggesting that emotional difficulties shared in NDDs may be partly attributed to shared atypical visual information processing.",2020,Processing happy and angry faces compared to flowers yielded similar activation in occipital regions in the NDDs compared to TDs.,"['across neurodevelopmental disorders', '279 children, 5-19 years of age but 57 were excluded due to excessive motion in fMRI, leaving 222: 87 ASD, 44 ADHD, 42 OCD and 49 TD', 'Autism spectrum disorder (ASD', 'children with autism spectrum disorder, attention deficit hyperactivity disorder and obsessive-compulsive disorder']",['Emotional face processing'],"['Dynamic faces (happy, angry) and dynamic flowers', 'activity patterns']","[{'cui': 'C1535926', 'cui_str': 'Neurodevelopmental disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0330090', 'cui_str': 'Flowers'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",279.0,0.04751,Processing happy and angry faces compared to flowers yielded similar activation in occipital regions in the NDDs compared to TDs.,"[{'ForeName': 'Marlee M', 'Initials': 'MM', 'LastName': 'Vandewouw', 'Affiliation': 'Department of Diagnostic Imaging, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'EunJung', 'Initials': 'E', 'LastName': 'Choi', 'Affiliation': 'Department of Diagnostic Imaging, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hammill', 'Affiliation': 'Program in Neurosciences & Mental Health, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Arnold', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Schachar', 'Affiliation': 'Program in Neurosciences & Mental Health, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Lerch', 'Affiliation': 'Program in Neurosciences & Mental Health, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Evdokia', 'Initials': 'E', 'LastName': 'Anagnostou', 'Affiliation': 'Program in Neurosciences & Mental Health, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Margot J', 'Initials': 'MJ', 'LastName': 'Taylor', 'Affiliation': 'Department of Diagnostic Imaging, Hospital for Sick Children, Toronto, Canada. margot.taylor@sickkids.ca.'}]",Translational psychiatry,['10.1038/s41398-020-01063-2']
1803,33139710,Nimodipine improves cortical efficiency during working memory in healthy subjects.,"The L-type calcium channel gene, CACNA1C, is a validated risk gene for schizophrenia and the target of calcium channel blockers. Carriers of the risk-associated genotype (rs1006737 A allele) have increased frontal cortical activity during working memory and higher CACNA1C mRNA expression in the prefrontal cortex. The aim of this study was to determine how the brain-penetrant calcium channel blocker, nimodipine, changes brain activity during working memory and other cognitive and emotional processes. We conducted a double-blind randomized cross-over pharmacoMRI study of a single 60 mg dose of oral nimodipine solution and matching placebo in healthy men, prospectively genotyped for rs1006737. With performance unchanged, nimodipine significantly decreased frontal cortical activity by 39.1% and parietal cortical activity by 42.8% during the N-back task (2-back > 0-back contrast; P FWE < 0.05; n = 28). Higher peripheral nimodipine concentrations were correlated with a greater decrease in activation in the frontal cortex. Carriers of the risk-associated allele, A (n = 14), had a greater decrease in frontal cortical activation during working memory compared to non-risk allele carriers. No differences in brain activation were found between nimodipine and placebo for other tasks. Future studies should be conducted to test if the decreased cortical brain activity after nimodipine is associated with improved working memory performance in patients with schizophrenia, particularly those who carry the risk-associated genotype. Furthermore, changes in cortical activity during working memory may be a useful biomarker in future trials of L-type calcium channel blockers.",2020,Carriers of the risk-associated genotype (rs1006737 A allele) have increased frontal cortical activity during working memory and higher CACNA1C mRNA expression in the prefrontal cortex.,"['healthy men, prospectively genotyped for rs1006737', 'patients with schizophrenia', 'healthy subjects']","['oral nimodipine solution and matching placebo', 'placebo', 'nimodipine', 'Nimodipine']","['frontal cortical activation', 'cortical efficiency', 'brain activation', 'frontal cortical activity', 'cortical activity', 'parietal cortical activity', 'Higher peripheral nimodipine concentrations', 'cortical brain activity']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",,0.151243,Carriers of the risk-associated genotype (rs1006737 A allele) have increased frontal cortical activity during working memory and higher CACNA1C mRNA expression in the prefrontal cortex.,"[{'ForeName': 'Caroline F', 'Initials': 'CF', 'LastName': 'Zink', 'Affiliation': 'Baltimore Research and Education Foundation, Baltimore, MD, United States.'}, {'ForeName': 'Mellissa', 'Initials': 'M', 'LastName': 'Giegerich', 'Affiliation': 'Lieber Institute for Brain Development, Baltimore, MD, United States.'}, {'ForeName': 'Greer E', 'Initials': 'GE', 'LastName': 'Prettyman', 'Affiliation': 'Lieber Institute for Brain Development, Baltimore, MD, United States.'}, {'ForeName': 'Kayla E', 'Initials': 'KE', 'LastName': 'Carta', 'Affiliation': 'Lieber Institute for Brain Development, Baltimore, MD, United States.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'van Ginkel', 'Affiliation': 'Lieber Institute for Brain Development, Baltimore, MD, United States.'}, {'ForeName': 'Molly P', 'Initials': 'MP', 'LastName': ""O'Rourke"", 'Affiliation': 'Lieber Institute for Brain Development, Baltimore, MD, United States.'}, {'ForeName': 'Eesha', 'Initials': 'E', 'LastName': 'Singh', 'Affiliation': 'Lieber Institute for Brain Development, Baltimore, MD, United States.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Fuchs', 'Affiliation': 'Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Breakey', 'Affiliation': 'Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Hummert', 'Affiliation': 'Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Jay J', 'Initials': 'JJ', 'LastName': 'Pillai', 'Affiliation': 'Department of Radiology and Radiological Science, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Weinberger', 'Affiliation': 'Lieber Institute for Brain Development, Baltimore, MD, United States.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Bigos', 'Affiliation': 'Lieber Institute for Brain Development, Baltimore, MD, United States. kbigos1@jh.edu.'}]",Translational psychiatry,['10.1038/s41398-020-01066-z']
1804,33139757,Probiotic supplementation in marathonists and its impact on lymphocyte population and function after a marathon: a randomized placebo-controlled double-blind study.,"Probiotic supplementation arises as playing an immune-stimulatory role. High-intensity and -volume exercise can inhibit immune cell function, which threatens athletic performance and recovery. We hypothesized that 30 days of probiotic supplementation could stabilize the immune system of athletes preventing immune suppression after a marathon race. Twenty-seven male marathonists were double-blinded randomly into probiotic (Bifidobacterium-animalis-subsp.-Lactis (10 × 10 9 ) and Lactobacillus-Acidophilus (10 × 10 9 ) + 5 g of maltodextrin) and placebo (5 g of maltodextrin) group. They received 30 sachets and supplemented 1 portion/day during 30 days before the race. Blood were collected 30 days before (rest), 1 day before (pre), 1 h after (post) and 5 days after the race (recovery). Both chronic and acute exercise modulated a different T lymphocyte population (CD3 + CD4 - CD8 - T-cells), increasing pre-race, decreasing post and returning to rest values at the recovery. The total number of CD8 T cell and the memory subsets statistically decreased only in the placebo group post-race. Pro-inflammatory cytokine production by stimulated lymphocytes decreased in the probiotic group after the supplementation period. 30 days of probiotic supplementation maintained CD8 T cell and effector memory cell population and played an immunomodulatory role in stimulated lymphocytes. Both, training and marathon modulated a non-classical lymphocyte population regardless of probiotic supplementation.",2020,30 days of probiotic supplementation maintained CD8 T cell and effector memory cell population and played an immunomodulatory role in stimulated lymphocytes.,['Twenty-seven male marathonists'],"['placebo', 'Probiotic supplementation', 'probiotic supplementation', 'probiotic (Bifidobacterium-animalis-subsp.-Lactis (10\u2009×\u200910 9 ) and Lactobacillus-Acidophilus (10\u2009×\u200910 9 )\u2009+\u20095\xa0g of maltodextrin) and placebo (5\xa0g of maltodextrin']","['Pro-inflammatory cytokine production', 'total number of CD8 T cell and the memory subsets']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",27.0,0.2654,30 days of probiotic supplementation maintained CD8 T cell and effector memory cell population and played an immunomodulatory role in stimulated lymphocytes.,"[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Batatinha', 'Affiliation': 'Immunometabolism Research Group, Institute of Biomedical Sciences, University of São Paulo (USP), São Paulo, SP, Brazil. batatinha.helena@usp.br.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Tavares-Silva', 'Affiliation': 'Programa de pós-graduação em psicobiologia, Universidade Federal de São Paulo, Santos, Brazil.'}, {'ForeName': 'Geovana S F', 'Initials': 'GSF', 'LastName': 'Leite', 'Affiliation': 'Laboratory of Applied Nutrition and Metabolism, School of Physical Education and Sports, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ayane S', 'Initials': 'AS', 'LastName': 'Resende', 'Affiliation': 'Laboratory of Applied Nutrition and Metabolism, School of Physical Education and Sports, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José A T', 'Initials': 'JAT', 'LastName': 'Albuquerque', 'Affiliation': 'Department of Immunology, Institute of Biomedical Sciences, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Arslanian', 'Affiliation': 'Department of Immunology, Institute of Biomedical Sciences, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ricardo A', 'Initials': 'RA', 'LastName': 'Fock', 'Affiliation': 'Department of Clinical and Toxicological Analysis, School of Pharmaceutical Sciences, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Antônio H', 'Initials': 'AH', 'LastName': 'Lancha', 'Affiliation': 'Laboratory of Applied Nutrition and Metabolism, School of Physical Education and Sports, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fabio S', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), School of Technology and Sciences, Presidente Prudente, Brazil.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Krüger', 'Affiliation': 'Department of Exercise Physiology and Sports Therapy, Justus-Liebig-University Giessen, Giessen, Germany.'}, {'ForeName': 'Ronaldo', 'Initials': 'R', 'LastName': 'Thomatieli-Santos', 'Affiliation': 'Programa de pós-graduação em psicobiologia, Universidade Federal de São Paulo, Santos, Brazil.'}, {'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Rosa-Neto', 'Affiliation': 'Immunometabolism Research Group, Institute of Biomedical Sciences, University of São Paulo (USP), São Paulo, SP, Brazil.'}]",Scientific reports,['10.1038/s41598-020-75464-0']
1805,33139834,A single bout of downhill running attenuates subsequent level running-induced fatigue.,"Fatigue can be defined as exercise-induced strength loss. During running, fatigue can be partially explained by repetitive low-intensity eccentric contractions-induced muscle damage (EIMD). Previous studies showed that a bout of downhill running (DR) attenuated subsequent EIMD. Thus, we tested if a 30-min DR bout would attenuate fatigue induced by subsequent 60-min level running (LR). Twenty-seven male college students were randomly allocated to an experimental (EXP) or a control (CON) group. All participants performed LR on a treadmill at 70% of the velocity (vVO 2 peak) corresponding to peak oxygen uptake (VO 2 peak). Only EXP performed a 30-min DR (- 15%) on a treadmill at 70% vVO 2 peak fourteen days before LR. Indirect EIMD markers and neuromuscular function were assessed before, immediately and 48 h after DR and LR. Knee extension isometric peak torque (IPT) decreased (- 36.3 ± 26%, p < 0.05) immediately following DR with full recovery reached 48 h post-DR. Muscle soreness developed (p < 0.05) immediately (37 ± 25 mm) and 48 h (45 ± 26 mm) post-DR. IPT and rate of torque development (RTD) at late phases (> 150 ms) from the onset of muscle contraction decreased significantly (- 10.7 ± 6.1% and from - 15.4 to - 18.7%, respectively) immediately after LR for the CON group and remained below baseline values (- 5.6 ± 8.5% and from - 13.8 to - 14.9%, respectively) 48 h post-LR. However, IPT and late RTD were not significantly affected by LR for the EXP group, showing a group x time interaction effect. We concluded that a single DR bout can be used to attenuate fatigue induced by a LR performed fourteen days after.",2020,"Knee extension isometric peak torque (IPT) decreased (- 36.3 ± 26%, p < 0.05) immediately following DR with full recovery reached 48 h post-DR.",['Twenty-seven male college students'],['experimental (EXP) or a control (CON'],"['muscle contraction', 'Muscle soreness', 'Indirect EIMD markers and neuromuscular function', 'Knee extension isometric peak torque (IPT', 'IPT and rate of torque development (RTD', 'IPT and late RTD']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0266313', 'cui_str': 'Renal tubular dysgenesis'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",27.0,0.0966474,"Knee extension isometric peak torque (IPT) decreased (- 36.3 ± 26%, p < 0.05) immediately following DR with full recovery reached 48 h post-DR.","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'de Oliveira Assumpção', 'Affiliation': 'Human Performance Laboratory, Department of Physical Education, IB, São Paulo State University, UNESP, Av. 24A, 1.515, Bela Vista, Rio Claro, São Paulo, CEP 13506-900, Brazil.'}, {'ForeName': 'Renan Vieira', 'Initials': 'RV', 'LastName': 'Barreto', 'Affiliation': 'Human Performance Laboratory, Department of Physical Education, IB, São Paulo State University, UNESP, Av. 24A, 1.515, Bela Vista, Rio Claro, São Paulo, CEP 13506-900, Brazil.'}, {'ForeName': 'Leonardo Coelho Rabello', 'Initials': 'LCR', 'LastName': 'de Lima', 'Affiliation': 'Human Performance Laboratory, Department of Physical Education, IB, São Paulo State University, UNESP, Av. 24A, 1.515, Bela Vista, Rio Claro, São Paulo, CEP 13506-900, Brazil.'}, {'ForeName': 'Adalgiso Coscrato', 'Initials': 'AC', 'LastName': 'Cardozo', 'Affiliation': 'Biomechanics Laboratory, Department of Physical Education, São Paulo State University, Rio Claro, São Paulo, Brazil.'}, {'ForeName': 'Maria Imaculada', 'Initials': 'MI', 'LastName': 'de Lima Montebelo', 'Affiliation': 'Graduate Program in Human Movement Sciences, Methodist University of Piracicaba - UNIMEP, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Helen Reinhart Camargo', 'Initials': 'HRC', 'LastName': 'Catarino', 'Affiliation': 'University Center of Itapira - UNIESI, Itapira, São Paulo, Brazil.'}, {'ForeName': 'Camila Coelho', 'Initials': 'CC', 'LastName': 'Greco', 'Affiliation': 'Human Performance Laboratory, Department of Physical Education, IB, São Paulo State University, UNESP, Av. 24A, 1.515, Bela Vista, Rio Claro, São Paulo, CEP 13506-900, Brazil.'}, {'ForeName': 'Benedito Sergio', 'Initials': 'BS', 'LastName': 'Denadai', 'Affiliation': 'Human Performance Laboratory, Department of Physical Education, IB, São Paulo State University, UNESP, Av. 24A, 1.515, Bela Vista, Rio Claro, São Paulo, CEP 13506-900, Brazil. bdenadai@rc.unesp.br.'}]",Scientific reports,['10.1038/s41598-020-76008-2']
1806,33140104,A Game Show-Based Curriculum for Teaching Principles of Reproductive Infectious Disease (GBS PRIDE Trial).,"OBJECTIVES
The purpose of this study was to evaluate whether a game show-based curriculum improves obstetrics and gynecology (OBGYN) residents' confidence in and understanding of the principles of reproductive infectious disease (RID), clinical manifestations and sequelae of sexually transmitted infection (STI), and management of serious long-term consequences of STIs.
METHODS
A game show-based curriculum was developed from the basic principles of RID, which include the following: (1) distinguishing between clinical manifestations of STIs and management of long-term sequelae of STIs; (2) evaluation and management of common gynecologic infectious diseases, including chronic vaginitis, pelvic inflammatory disease, and other pelvic infections; (3) diagnosis and management of perinatal infectious diseases, such as parvovirus, varicella-zoster virus, cytomegalovirus, human immunodeficiency virus, toxoplasmosis, and infection-mediated prematurity; (4) evaluation and management of obstetric and gynecologic postoperative infections; and (5) diagnosis and management of acute and chronic human immunodeficiency virus and hepatitis C virus infections in pregnancy. OBGYN residents at a large urban academic training program were randomized to either a Jeopardy -style educational game show intervention plus a traditional didactic-based curriculum or traditional didactic-based curriculum alone. The study team recruited participants by sending out an e-mail to all of the residents, detailing the study and consent process. Participants from both the intervention and control groups completed confidence and knowledge-based pretests. Posttests were administered 4 weeks after completion of the pretests. Statistical methods were applied to analyze the data.
RESULTS
Thirty-eight residents were randomized to a Jeopardy -style game show-based educational intervention (n = 19) or to a traditional didactic-based curriculum (n = 19). All of the participants (100%) completed the pre- and posttests. Pretest median scores were similar between both groups, in which the Jeopardy group had a median score of 48.5 and the traditional group had a median score of 51.4 ( P = 0.091). The Jeopardy group median test scores improved between the pretest and posttest (48.5 vs 62.8, P ≤ 0.001). The traditional didactic-based curriculum had a minimal increase in its median posttest scores (51.4 compared with 54.2, P = 0.773). The Jeopardy group had significantly higher posttest median scores and confidence scores than the traditional didactic-based curriculum ( Jeopardy = 62.8, traditional = 54.2, P = 0.002).
CONCLUSIONS
A game show-based curriculum improves OBGYN residents' confidence and retention of knowledge regarding RIDs, clinical manifestations and sequelae of STIs, and management of serious long-term consequences of STIs. Additional studies that include longer posttest time intervals are needed to assess the longer-term impact of game show-based curriculum on knowledge retention among OBGYN residents.",2020,"The Jeopardy group had significantly higher posttest median scores and confidence scores than the traditional didactic-based curriculum ( Jeopardy = 62.8, traditional = 54.2, P = 0.002).
","['residents at a large urban academic training program', 'participants by sending out an e-mail to all of the residents, detailing the study and consent process', 'Thirty-eight residents']","['Jeopardy -style educational game show intervention plus a traditional didactic-based curriculum or traditional didactic-based curriculum alone', 'Jeopardy -style game show-based educational intervention', 'traditional didactic-based curriculum']","['posttest median scores and confidence scores', 'median posttest scores', 'Pretest median scores']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0000875', 'cui_str': 'Academic Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0450361', 'cui_str': '38'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",38.0,0.0638697,"The Jeopardy group had significantly higher posttest median scores and confidence scores than the traditional didactic-based curriculum ( Jeopardy = 62.8, traditional = 54.2, P = 0.002).
","[{'ForeName': 'Sharlay K', 'Initials': 'SK', 'LastName': 'Butler', 'Affiliation': 'From the Department of Obstetrics, Gynecology, and Reproductive Sciences, the University of Pittsburgh, Pittsburgh, Pennsylvania and the Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Runge', 'Affiliation': 'From the Department of Obstetrics, Gynecology, and Reproductive Sciences, the University of Pittsburgh, Pittsburgh, Pennsylvania and the Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Magdy P', 'Initials': 'MP', 'LastName': 'Milad', 'Affiliation': 'From the Department of Obstetrics, Gynecology, and Reproductive Sciences, the University of Pittsburgh, Pittsburgh, Pennsylvania and the Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}]",Southern medical journal,['10.14423/SMJ.0000000000001165']
1807,33140132,[Use of components of the transitional care model in geriatric cross-sectoral care in Germany-Results of a survey].,"BACKGROUND
The inclusion of transitional care professionals to improve the sectoral interface management is politically supported. The nine components of the transitional care model (TCM) originating from the USA, are used in a randomized controlled trial within the TIGER project, which is funded by the Federal Joint Committee of Germany. Geriatric patients are accompanied prior to discharge from hospital and up to 12 months after discharge in the home environment.
OBJECTIVE
Within the framework of the TIGER project a nationwide survey was carried out on the use of the TCM components in the accompanied transition from hospital to home in the field of geriatrics.
MATERIAL AND METHODS
A data collection was set up to establish contact with people from the immediate and care policy environment of geriatrics. In a 2-stage process, the first question was whether a geriatric project was known that focuses on the transition from hospital to home in geriatric patients. After confirmation, a questionnaire could be filled out online or by post.
RESULTS
A total of 31 different projects out of 39 answered questionnaires were identified. Principally, all TCM components were used in the projects. The TCM component 9 that describes the coordination of support and aids, was mentioned most often (n = 30). The TCM components 6 (improvement in self-management) and 8 (promoting continuity) were used in only 19 projects.
CONCLUSION
Management of the transsectoral transition is a current topic in the field of geriatrics in Germany. The TCM components that have proved to be important in reducing hospital readmission rates have predominantly been used in the projects.",2020,"The nine components of the transitional care model (TCM) originating from the USA, are used in a randomized controlled trial within the TIGER project, which is funded by the Federal Joint Committee of Germany.","['geriatric patients', 'Geriatric patients', 'A\xa0total of 31 different projects out of 39 answered questionnaires were identified']",[],['hospital readmission rates'],"[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]",[],"[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}]",39.0,0.0219997,"The nine components of the transitional care model (TCM) originating from the USA, are used in a randomized controlled trial within the TIGER project, which is funded by the Federal Joint Committee of Germany.","[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Morkisch', 'Affiliation': 'Bundesverband Geriatrie e.\u202fV., Reinickendorfer Str.\xa061, 13347, Berlin, Deutschland.'}, {'ForeName': 'Luz Dary', 'Initials': 'LD', 'LastName': 'Upegui-Arango', 'Affiliation': 'Bundesverband Geriatrie e.\u202fV., Reinickendorfer Str.\xa061, 13347, Berlin, Deutschland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'van den Heuvel', 'Affiliation': 'Bundesverband Geriatrie e.\u202fV., Reinickendorfer Str.\xa061, 13347, Berlin, Deutschland. dirk.van-den-heuvel@bv-geriatrie.de.'}]",Zeitschrift fur Gerontologie und Geriatrie,['10.1007/s00391-020-01804-4']
1808,33140173,"Effects of capillary refill time-vs. lactate-targeted fluid resuscitation on regional, microcirculatory and hypoxia-related perfusion parameters in septic shock: a randomized controlled trial.","BACKGROUND
Persistent hyperlactatemia has been considered as a signal of tissue hypoperfusion in septic shock patients, but multiple non-hypoperfusion-related pathogenic mechanisms could be involved. Therefore, pursuing lactate normalization may lead to the risk of fluid overload. Peripheral perfusion, assessed by the capillary refill time (CRT), could be an effective alternative resuscitation target as recently demonstrated by the ANDROMEDA-SHOCK trial. We designed the present randomized controlled trial to address the impact of a CRT-targeted (CRT-T) vs. a lactate-targeted (LAC-T) fluid resuscitation strategy on fluid balances within 24 h of septic shock diagnosis. In addition, we compared the effects of both strategies on organ dysfunction, regional and microcirculatory flow, and tissue hypoxia surrogates.
RESULTS
Forty-two fluid-responsive septic shock patients were randomized into CRT-T or LAC-T groups. Fluids were administered until target achievement during the 6 h intervention period, or until safety criteria were met. CRT-T was aimed at CRT normalization (≤ 3 s), whereas in LAC-T the goal was lactate normalization (≤ 2 mmol/L) or a 20% decrease every 2 h. Multimodal perfusion monitoring included sublingual microcirculatory assessment; plasma-disappearance rate of indocyanine green; muscle oxygen saturation; central venous-arterial pCO 2 gradient/ arterial-venous O 2 content difference ratio; and lactate/pyruvate ratio. There was no difference between CRT-T vs. LAC-T in 6 h-fluid boluses (875 [375-2625] vs. 1500 [1000-2000], p = 0.3), or balances (982[249-2833] vs. 15,800 [740-6587, p = 0.2]). CRT-T was associated with a higher achievement of the predefined perfusion target (62 vs. 24, p = 0.03). No significant differences in perfusion-related variables or hypoxia surrogates were observed.
CONCLUSIONS
CRT-targeted fluid resuscitation was not superior to a lactate-targeted one on fluid administration or balances. However, it was associated with comparable effects on regional and microcirculatory flow parameters and hypoxia surrogates, and a faster achievement of the predefined resuscitation target. Our data suggest that stopping fluids in patients with CRT ≤ 3 s appears as safe in terms of tissue perfusion. Clinical Trials: ClinicalTrials.gov Identifier: NCT03762005 (Retrospectively registered on December 3rd 2018).",2020,"CRT-T was associated with a higher achievement of the predefined perfusion target (62 vs. 24, p = 0.03).","['24\xa0h of septic shock diagnosis', 'septic shock', 'septic shock patients', 'Forty-two fluid-responsive septic shock patients']","['CRT-targeted (CRT-T) vs. a lactate-targeted (LAC-T) fluid resuscitation strategy', 'lactate-targeted fluid resuscitation']","['organ dysfunction, regional and microcirculatory flow, and tissue hypoxia surrogates', 'capillary refill time (CRT', 'regional and microcirculatory flow parameters and hypoxia surrogates', 'perfusion-related variables or hypoxia surrogates', 'fluid balances']","[{'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}]","[{'cui': 'C0425716', 'cui_str': 'Capillary filling'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0425716', 'cui_str': 'Capillary filling'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}]",,0.147546,"CRT-T was associated with a higher achievement of the predefined perfusion target (62 vs. 24, p = 0.03).","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Castro', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Diagonal Paraguay 362, Santiago, Chile.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Kattan', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Diagonal Paraguay 362, Santiago, Chile.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Ferri', 'Affiliation': 'Unidad de Cuidados Intensivos, Hospital Barros Luco-Trudeau, Santiago, Chile.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Pairumani', 'Affiliation': 'Unidad de Cuidados Intensivos, Hospital Barros Luco-Trudeau, Santiago, Chile.'}, {'ForeName': 'Emilio Daniel', 'Initials': 'ED', 'LastName': 'Valenzuela', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Diagonal Paraguay 362, Santiago, Chile.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Alegría', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Diagonal Paraguay 362, Santiago, Chile.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Oviedo', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Diagonal Paraguay 362, Santiago, Chile.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Pavez', 'Affiliation': 'Departamento de Medicina Interna, Facultad de Medicina, Universidad de Concepción, Concepción, Chile.'}, {'ForeName': 'Dagoberto', 'Initials': 'D', 'LastName': 'Soto', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Diagonal Paraguay 362, Santiago, Chile.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Vera', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Diagonal Paraguay 362, Santiago, Chile.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Santis', 'Affiliation': 'Unidad de Cuidados Intensivos, Hospital Barros Luco-Trudeau, Santiago, Chile.'}, {'ForeName': 'Brusela', 'Initials': 'B', 'LastName': 'Astudillo', 'Affiliation': 'Unidad de Cuidados Intensivos, Hospital Barros Luco-Trudeau, Santiago, Chile.'}, {'ForeName': 'María Alicia', 'Initials': 'MA', 'LastName': 'Cid', 'Affiliation': 'Unidad de Cuidados Intensivos, Hospital Barros Luco-Trudeau, Santiago, Chile.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bravo', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Diagonal Paraguay 362, Santiago, Chile.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Ospina-Tascón', 'Affiliation': 'Department of Intensive Care Medicine, Fundación Valle del Lili, Universidad ICES, Cali, Colombia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Diagonal Paraguay 362, Santiago, Chile.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Hernández', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Diagonal Paraguay 362, Santiago, Chile. glennguru@gmail.com.'}]",Annals of intensive care,['10.1186/s13613-020-00767-4']
1809,33140199,"Adrenomedullin for steroid-resistant ulcerative colitis: a randomized, double-blind, placebo-controlled phase-2a clinical trial.","BACKGROUND
Adrenomedullin (AM) is a bioactive peptide having many pleiotropic effects, including mucosal healing and immunomodulation. AM has shown beneficial effects in rodent models and in preliminary study for patients with ulcerative colitis (UC). We performed a clinical trial to investigate the efficacy and safety of AM in patients with UC.
METHODS
This was a multi-center, double-blind, placebo-controlled phase-2a trial evaluating 28 patients in Japan with steroid-resistant UC. Patients were randomly assigned to four groups and given an infusion of 5, 10, 15 ng/kg/min of AM or placebo for 8 h per day for 14 days. The primary endpoint was the change in Mayo scores at 2 weeks. Main secondary endpoints included the change in Mayo scores and the rate of clinical remission at 8 weeks, defined as a Mayo score 0.
RESULTS
No differences in the primary or secondary endpoints were observed among the four groups at 2 weeks. Despite the insufficient tracking rate, the Mayo score at 8 weeks was only significantly decreased in the high-dose AM group (15 ng/kg/min) compared with the placebo group (- 9.3 ± 1.2 vs. - 3.0 ± 2.8, P = 0.035), with its rate of clinical remission at 8 weeks being significantly higher (3/3, 100% vs. 0/2, 0%, P = 0.025). We noted mild but no serious adverse events caused by the vasodilatory effect of AM.
CONCLUSIONS
In this double-blind randomized trial, we observed the complete remission at 8 weeks in patients with steroid-resistant UC receiving a high dose of AM.
CLINICAL TRIAL REGISTRY
JAPIC clinical trials information; Japic CTI-205255 (200410115290). https://www.clinicaltrials.jp/cti-user/trial/Search.jsp .",2020,"Despite the insufficient tracking rate, the Mayo score at 8 weeks was only significantly decreased in the high-dose AM group (15 ng/kg/min) compared with the placebo group (- 9.3 ± 1.2 vs. - 3.0 ± 2.8, P = 0.035), with its rate of clinical remission at 8 weeks being significantly higher (3/3, 100% vs. 0/2, 0%, P = 0.025).","['steroid-resistant ulcerative colitis', 'patients with ulcerative colitis (UC', 'patients with UC', '28 patients in Japan with steroid-resistant UC', 'patients with steroid-resistant UC receiving a high dose of AM']","['AM or placebo', 'placebo', 'AM']","['change in Mayo scores', 'efficacy and safety', 'change in Mayo scores and the rate of clinical remission at 8\xa0weeks, defined as a Mayo score 0', 'Mayo score', 'rate of clinical remission']","[{'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0215825', 'cui_str': 'ADM(1-52)'}]","[{'cui': 'C0215825', 'cui_str': 'ADM(1-52)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]",,0.734339,"Despite the insufficient tracking rate, the Mayo score at 8 weeks was only significantly decreased in the high-dose AM group (15 ng/kg/min) compared with the placebo group (- 9.3 ± 1.2 vs. - 3.0 ± 2.8, P = 0.035), with its rate of clinical remission at 8 weeks being significantly higher (3/3, 100% vs. 0/2, 0%, P = 0.025).","[{'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Kita', 'Affiliation': 'Division of Circulatory and Body Fluid Regulation, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Miyazaki, Miyazaki, 889-1692, Japan. toshihiro_kita@med.miyazaki-u.ac.jp.'}, {'ForeName': 'Sinya', 'Initials': 'S', 'LastName': 'Ashizuka', 'Affiliation': 'Division of Circulatory and Body Fluid Regulation, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Miyazaki, Miyazaki, 889-1692, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ohmiya', 'Affiliation': 'Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'IBD Center, Yokkaichi Hazu Medical Center, Yokkaichi, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Kanai', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Motoya', 'Affiliation': 'IBD Center, Sapporo Kosei General Hospital, Sapporo, Japan.'}, {'ForeName': 'Fumihito', 'Initials': 'F', 'LastName': 'Hirai', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nakase', 'Affiliation': 'Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Moriyama', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Masanao', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Gastroenterology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Kanmura', 'Affiliation': 'Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.'}, {'ForeName': 'Hidehisa', 'Initials': 'H', 'LastName': 'Ohi', 'Affiliation': 'Department of Gastroenterology, Idzuro Imamura Hospital, Kagoshima, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Nozaki', 'Affiliation': 'Coloproctology Center Takano Hospital, Kumamoto, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Mitsuyama', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Shojiro', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Gastroenterology and Hematology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Inatsu', 'Affiliation': 'Division of Circulatory and Body Fluid Regulation, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Miyazaki, Miyazaki, 889-1692, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Division of Circulatory and Body Fluid Regulation, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Miyazaki, Miyazaki, 889-1692, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hibi', 'Affiliation': 'Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kitamura', 'Affiliation': 'Division of Circulatory and Body Fluid Regulation, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Miyazaki, Miyazaki, 889-1692, Japan.'}]",Journal of gastroenterology,['10.1007/s00535-020-01741-4']
1810,33115536,"Numbers, graphs and words - do we really understand the lab test results accessible via the patient portals?","BACKGROUND
The heavy reliance on remote patient care (RPC) during the COVID-19 health crisis may have expedited the emergence of digital health tools that can contribute to safely and effectively moving the locus of care from the hospital to the community. Understanding how laypersons interpret the personal health information accessible to them via electronic patient records (EPRs) is crucial to healthcare planning and the design of services. Yet we still know little about how the format in which personal medical information is presented in the EPR (numerically, verbally, or graphically) affects individuals' understanding of the information, their assessment of its gravity, and the course of action they choose in response.
METHODS
We employed an online questionnaire to assess respondents' reactions to 10 medical decision-making scenarios, where the same information was presented using different formats. In each scenario, respondents were presented with real (anonymized) patient lab results using either numeric expressions, graphs, or verbal expressions. Participants were asked to assess the gravity of the hypothetical patient's condition and the course of action they would follow if they were that patient. The questionnaire was distributed to more than 300 participants, of whom 225 submitted usable responses.
RESULTS
Laypersons were more likely to overestimate the gravity of the information when it was presented either numerically or graphically compared to the narrative format. High perceived gravity was most likely to produce an inclination to actively seek medical attention, even when unwarranted. ""Don't know"" responses were most likely to produce an inclination to either search the Internet or wait for the doctor to call.
POLICY RECOMMENDATIONS
We discuss the study's implications for the effective design of lab results in the patient portals. We suggest (1) that graphs, tables, and charts would be easier to interpret if coupled with a brief verbal explanation; (2) that highlighting an overall level of urgency may be more helpful than indicating a diversion from the norm; and (3) that statements of results should include the type of follow-up required.",2020,"RESULTS
Laypersons were more likely to overestimate the gravity of the information when it was presented either numerically or graphically compared to the narrative format.","['300 participants, of whom 225 submitted usable responses']",[],[],"[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517652', 'cui_str': '225'}]",[],[],,0.0374507,"RESULTS
Laypersons were more likely to overestimate the gravity of the information when it was presented either numerically or graphically compared to the narrative format.","[{'ForeName': 'Shirly', 'Initials': 'S', 'LastName': 'Bar-Lev', 'Affiliation': 'Dror (Imri) Aloni Center for Health Informatics, Tel Aviv, Israel. barlevsh@ruppin.ac.il.'}, {'ForeName': 'Dizza', 'Initials': 'D', 'LastName': 'Beimel', 'Affiliation': 'Dror (Imri) Aloni Center for Health Informatics, Tel Aviv, Israel.'}]",Israel journal of health policy research,['10.1186/s13584-020-00415-z']
1811,32997666,Validation of the Micronutrient and Environmental Enteric Dysfunction Assessment Tool and evaluation of biomarker risk factors for growth faltering and vaccine failure in young Malian children.,"Environmental enteric dysfunction (EED) is an intestinal disorder common among children in low-resource settings and is associated with increased risk of growth stunting, cognitive deficits, and reduced oral vaccine immunogenicity. The Micronutrient and EED Assessment Tool (MEEDAT) is a multiplexed immunoassay that measures biomarkers previously associated with child growth faltering and/or oral vaccine immunogenicity: intestinal fatty acid-binding protein (I-FABP), soluble CD14 (sCD14), insulin-like growth factor 1 (IGF-1), and fibroblast growth factor 21 (FGF21). MEEDAT also measures systemic inflammation (α1-acid glycoprotein, C-reactive protein), ferritin, soluble transferrin receptor, retinol binding protein 4, thyroglobulin, and Plasmodium falciparum antigenemia (histidine-rich protein 2). The performance of MEEDAT was compared with commercially available enzyme-linked immunosorbent assays (ELISAs) using 300 specimens from Malian infant clinical trial participants. Regression methods were used to test if MEEDAT biomarkers were associated with seroconversion to meningococcal A conjugate vaccine (MenAV), yellow fever vaccine (YFV), and pentavalent rotavirus vaccine (PRV) after 28 days, or with growth faltering over 12 weeks. The Pearson correlations between the MEEDAT and ELISA results were 0.97, 0.86, 0.80, and 0.97 for serum I-FABP, sCD14, IGF-1, and FGF21, respectively. There were significant associations between I-FABP concentration and the probability of PRV IgG seroconversion and between IGF-1 concentration and the probability of YFV seroconversion. In multivariable models neither association remained significant, however there was a significant negative association between AGP concentration and YFV seroconversion. GLP-2 and sCD14 concentrations were significantly negatively associated with 12-week change in weight-for-age z-score and weight-for-height z-score in multivariable models. MEEDAT performed well in comparison to commercially-available ELISAs for the measurement of four analytes for EED and growth hormone resistance. Adoption of MEEDAT in low-resource settings could help accelerate the identification of interventions that prevent or treat child stunting and interventions that boost the immunogenicity of child vaccinations.",2020,"Regression methods were used to test if MEEDAT biomarkers were associated with seroconversion to meningococcal A conjugate vaccine (MenAV), yellow fever vaccine (YFV), and pentavalent rotavirus vaccine (PRV) after 28 days, or with growth faltering over 12 weeks.","['young Malian children', '300 specimens from Malian infant clinical trial participants']","['conjugate vaccine (MenAV), yellow fever vaccine (YFV), and pentavalent rotavirus vaccine (PRV', 'commercially available enzyme-linked immunosorbent assays (ELISAs']","['systemic inflammation (α1-acid glycoprotein, C-reactive protein), ferritin, soluble transferrin receptor, retinol binding protein 4, thyroglobulin, and Plasmodium falciparum antigenemia (histidine-rich protein 2', 'GLP-2 and sCD14 concentrations', 'AGP concentration and YFV seroconversion', 'I-FABP concentration and the probability of PRV IgG seroconversion and between IGF-1 concentration and the probability of YFV seroconversion']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}]","[{'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0301508', 'cui_str': 'Yellow Fever Vaccine'}, {'cui': 'C2713569', 'cui_str': 'pentavalent rotavirus vaccine (RV5)'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble'}, {'cui': 'C1438309', 'cui_str': 'RBP4 protein, human'}, {'cui': 'C0040123', 'cui_str': 'Thyroglobulin'}, {'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}, {'cui': 'C0062751', 'cui_str': 'histidine-rich proteins'}, {'cui': 'C0912332', 'cui_str': 'Glucagon-like peptide 2'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0029297', 'cui_str': 'Alpha-1- acid glycoprotein'}, {'cui': 'C0301508', 'cui_str': 'Yellow Fever Vaccine'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C2713569', 'cui_str': 'pentavalent rotavirus vaccine (RV5)'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}]",,0.0695645,"Regression methods were used to test if MEEDAT biomarkers were associated with seroconversion to meningococcal A conjugate vaccine (MenAV), yellow fever vaccine (YFV), and pentavalent rotavirus vaccine (PRV) after 28 days, or with growth faltering over 12 weeks.","[{'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Arndt', 'Affiliation': 'PATH, Seattle, Washington, United States of America.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Cantera', 'Affiliation': 'PATH, Seattle, Washington, United States of America.'}, {'ForeName': 'Laina D', 'Initials': 'LD', 'LastName': 'Mercer', 'Affiliation': 'PATH, Seattle, Washington, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kalnoky', 'Affiliation': 'PATH, Seattle, Washington, United States of America.'}, {'ForeName': 'Heather N', 'Initials': 'HN', 'LastName': 'White', 'Affiliation': 'PATH, Seattle, Washington, United States of America.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Bizilj', 'Affiliation': 'PATH, Seattle, Washington, United States of America.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Boyle', 'Affiliation': 'PATH, Seattle, Washington, United States of America.'}, {'ForeName': 'Eugenio L', 'Initials': 'EL', 'LastName': 'de Hostos', 'Affiliation': 'PATH, Seattle, Washington, United States of America.'}, {'ForeName': 'Robert K M', 'Initials': 'RKM', 'LastName': 'Choy', 'Affiliation': 'PATH, Seattle, Washington, United States of America.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008711']
1812,33140267,Effect of different treatments on recurrent aphthous stomatitis: laser versus medication.,"Recurrent aphthous stomatitis (RAS) is a common disease with ulcers in oral cavity which may trigger chewing, speaking, and swallowing difficulties to patients. Treatment of RAS is primarily aimed at pain relief and the promotion of wound healing. However, few agents have been found to have definite effect in the management of RAS and most of the medicinal products may cause adverse reactions or other disadvantages, which makes their clinical usage questionable. The purpose of this randomized controlled clinical trial (RCT) was to assess the clinical effect of diode laser and traditional medication treatment on RAS. In this study, 56 patients were randomly assigned to two groups (n = 28). Laser group was treated using diode laser (810 nm, 1.0 W, CW, irradiation time 20 s for 3 applications) once daily for continuous 3 days. Medication group was treated with triamcinolone acetonide 0.1% three times a day until the lesion was healed. Spontaneous and functional pain level on the third day of treatment was significantly less in the laser group. Significant difference was observed with respect to healing time; however, the order of difference is small albeit of statistical significance. Diode laser with the chosen parameters had better effects on pain relief and no distinct advantage on wound healing comparing with medication. Trial registration number: ChiCTR2000030298; date of registration: 26 February 2020 (retrospectively registered).",2020,Spontaneous and functional pain level on the third day of treatment was significantly less in the laser group.,['56 patients were randomly assigned to two groups (n = 28'],"['RAS', 'Diode laser', 'diode laser and traditional medication treatment', 'diode laser', 'triamcinolone acetonide']","['healing time', 'pain relief', 'wound healing', 'Spontaneous and functional pain level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",56.0,0.0537817,Spontaneous and functional pain level on the third day of treatment was significantly less in the laser group.,"[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Huo', 'Affiliation': ""Department of Oral Medicine, School and Hospital of Stomatology, Hebei Medical University & Hebei Key Laboratory of Stomatology, No. 383, Zhongshan East Road, Chang'an District, Shijiazhuang City, 050017, Hebei Province, China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Han', 'Affiliation': ""Department of Oral Medicine, School and Hospital of Stomatology, Hebei Medical University & Hebei Key Laboratory of Stomatology, No. 383, Zhongshan East Road, Chang'an District, Shijiazhuang City, 050017, Hebei Province, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Oral Medicine, School and Hospital of Stomatology, Hebei Medical University & Hebei Key Laboratory of Stomatology, No. 383, Zhongshan East Road, Chang'an District, Shijiazhuang City, 050017, Hebei Province, China. liuli2888@163.com.""}]",Lasers in medical science,['10.1007/s10103-020-03166-0']
1813,33140400,Are adipokines associated with atrial fibrillation in type 2 diabetes?,"INTRODUCTION
The potential effect of adipokines on the development of AF is yet to be established. The aim of this study was to investigate the association of baseline serum adipokines with 1) the presence of AF at baseline and 2) future risk of AF development.
MATERIAL AND METHODS
The current study is a sub-analysis of the prospective, randomised AVOCADO (Aspirin Vs./Or Clopidogrel in Aspirin-resistant Diabetics inflammation Outcomes) trial. The AVOCADO study included patients with type 2 DM burdened with at least two additional cardiovascular risk factors and receiving acetylsalicylic acid. In patients included in the current analysis adipokines and inflammatory biomarker levels were measured. Information on the subsequent AF diagnosis was collected after a median of 5.4 years of follow-up.
RESULTS
A total of 273 patients with type 2 DM (median age 68 years; 52% male) were included in the initial analysis comparing patients with and without AF at baseline. Patients with diagnosed AF (12%) had higher levels of serum resistin [8.5 (5.8-10.5) vs. 6.9 (5.6-8.7) ng/mL; p = 0.034], adiponectin [6.9 (5.6-8.7) vs. 2.7 (1.8-4.2) ng/mL; p = 0.032], and N-terminal pro-B-type natriuretic peptide [336 (148-473) vs. 108 [45-217]; p < 0.001) than non-AF patients. There were no significant differences in serum leptin, IL-6, and TNF-alpha concentrations between the two groups. From subjects without known AF at study entry, 19% developed AF at follow-up. In logistic regression analysis, baseline adipokine levels did not predict AF development.
CONCLUSION
In type 2 DM, patients with AF have higher resistin and adiponectin concentrations than patients with no AF. None of the studied adipokines proved a predictor of future AF development.",2020,"There were no significant differences in serum leptin, IL-6, and TNF-alpha concentrations between the two groups.","['Aspirin-resistant Diabetics', '273 patients with type 2 DM (median age 68 years; 52% male', 'patients with type 2 DM burdened with at least two additional cardiovascular risk factors and receiving']","['adipokines', 'AVOCADO (Aspirin Vs./Or Clopidogrel', 'acetylsalicylic acid']","['resistin and adiponectin concentrations', 'subsequent AF diagnosis', 'inflammatory biomarker levels', 'higher levels of serum resistin', 'serum leptin, IL-6, and TNF-alpha concentrations', 'adiponectin']","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0330230', 'cui_str': 'Avocado'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}]",273.0,0.166028,"There were no significant differences in serum leptin, IL-6, and TNF-alpha concentrations between the two groups.","[{'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Peller', 'Affiliation': '1st Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Kapłon-Cieślicka', 'Affiliation': '1st Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland. agnieszka.kaplon@gmail.com.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Rosiak', 'Affiliation': 'Department of Cardiology and Hypertension, Central Clinical Hospital, the Ministry of the Interior and Administration, Warsaw, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Tymińska', 'Affiliation': '1st Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Ozierański', 'Affiliation': '1st Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Ceren', 'Initials': 'C', 'LastName': 'Eyileten', 'Affiliation': 'Centre for Preclinical Research and Technology (CePT), Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Kondracka', 'Affiliation': 'Department of Internal Diseases and Endocrinology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Dagmara', 'Initials': 'D', 'LastName': 'Mirowska-Guzel', 'Affiliation': 'Centre for Preclinical Research and Technology (CePT), Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Opolski', 'Affiliation': '1st Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Postuła', 'Affiliation': 'Centre for Preclinical Research and Technology (CePT), Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Krzysztof J', 'Initials': 'KJ', 'LastName': 'Filipiak', 'Affiliation': '1st Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}]",Endokrynologia Polska,['10.5603/EP.a2019.0059']
1814,33140719,Robot-assisted training compared with an enhanced upper limb therapy programme and with usual care for upper limb functional limitation after stroke: the RATULS three-group RCT.,"BACKGROUND
Loss of arm function is common after stroke. Robot-assisted training may improve arm outcomes.
OBJECTIVE
The objectives were to determine the clinical effectiveness and cost-effectiveness of robot-assisted training, compared with an enhanced upper limb therapy programme and with usual care.
DESIGN
This was a pragmatic, observer-blind, multicentre randomised controlled trial with embedded health economic and process evaluations.
SETTING
The trial was set in four NHS trial centres.
PARTICIPANTS
Patients with moderate or severe upper limb functional limitation, between 1 week and 5 years following first stroke, were recruited.
INTERVENTIONS
Robot-assisted training using the Massachusetts Institute of Technology-Manus robotic gym system (InMotion commercial version, Interactive Motion Technologies, Inc., Watertown, MA, USA), an enhanced upper limb therapy programme comprising repetitive functional task practice, and usual care.
MAIN OUTCOME MEASURES
The primary outcome was upper limb functional recovery 'success' (assessed using the Action Research Arm Test) at 3 months. Secondary outcomes at 3 and 6 months were the Action Research Arm Test results, upper limb impairment (measured using the Fugl-Meyer Assessment), activities of daily living (measured using the Barthel Activities of Daily Living Index), quality of life (measured using the Stroke Impact Scale), resource use costs and quality-adjusted life-years.
RESULTS
A total of 770 participants were randomised (robot-assisted training, n = 257; enhanced upper limb therapy, n = 259; usual care, n = 254). Upper limb functional recovery 'success' was achieved in the robot-assisted training [103/232 (44%)], enhanced upper limb therapy [118/234 (50%)] and usual care groups [85/203 (42%)]. These differences were not statistically significant; the adjusted odds ratios were as follows: robot-assisted training versus usual care, 1.2 (98.33% confidence interval 0.7 to 2.0); enhanced upper limb therapy versus usual care, 1.5 (98.33% confidence interval 0.9 to 2.5); and robot-assisted training versus enhanced upper limb therapy, 0.8 (98.33% confidence interval 0.5 to 1.3). The robot-assisted training group had less upper limb impairment (as measured by the Fugl-Meyer Assessment motor subscale) than the usual care group at 3 and 6 months. The enhanced upper limb therapy group had less upper limb impairment (as measured by the Fugl-Meyer Assessment motor subscale), better mobility (as measured by the Stroke Impact Scale mobility domain) and better performance in activities of daily living (as measured by the Stroke Impact Scale activities of daily living domain) than the usual care group, at 3 months. The robot-assisted training group performed less well in activities of daily living (as measured by the Stroke Impact Scale activities of daily living domain) than the enhanced upper limb therapy group at 3 months. No other differences were clinically important and statistically significant. Participants found the robot-assisted training and the enhanced upper limb therapy group programmes acceptable. Neither intervention, as provided in this trial, was cost-effective at current National Institute for Health and Care Excellence willingness-to-pay thresholds for a quality-adjusted life-year.
CONCLUSIONS
Robot-assisted training did not improve upper limb function compared with usual care. Although robot-assisted training improved upper limb impairment, this did not translate into improvements in other outcomes. Enhanced upper limb therapy resulted in potentially important improvements on upper limb impairment, in performance of activities of daily living, and in mobility. Neither intervention was cost-effective.
FUTURE WORK
Further research is needed to find ways to translate the improvements in upper limb impairment seen with robot-assisted training into improvements in upper limb function and activities of daily living. Innovations to make rehabilitation programmes more cost-effective are required.
LIMITATIONS
Pragmatic inclusion criteria led to the recruitment of some participants with little prospect of recovery. The attrition rate was higher in the usual care group than in the robot-assisted training or enhanced upper limb therapy groups, and differential attrition is a potential source of bias. Obtaining accurate information about the usual care that participants were receiving was a challenge.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN69371850.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 54. See the NIHR Journals Library website for further project information.",2020,"The attrition rate was higher in the usual care group than in the robot-assisted training or enhanced upper limb therapy groups, and differential attrition is a potential source of bias.","['Patients with moderate or severe upper limb functional limitation, between 1 week and 5 years following first stroke, were recruited', '770 participants were', 'The trial was set in four NHS trial centres']","['randomised (robot-assisted training, n \u2009=\u2009257; enhanced upper limb therapy, n \u2009=\u2009259; usual care, n \u2009=\u2009254', 'robot-assisted training', 'robot-assisted training, compared with an enhanced upper limb therapy programme and with usual care', 'Technology-Manus robotic gym system (InMotion commercial version, Interactive Motion Technologies, Inc., Watertown, MA, USA', 'Robot-assisted training compared with an enhanced upper limb therapy programme and with usual care', 'robot-assisted training and the enhanced upper limb therapy', 'Robot-assisted training']","['clinical effectiveness and cost-effectiveness', 'Fugl-Meyer Assessment motor subscale), better mobility (as measured by the Stroke Impact Scale mobility domain) and better performance in activities of daily living (as measured by the Stroke Impact Scale activities of daily living domain', 'Action Research Arm Test results, upper limb impairment (measured using the Fugl-Meyer Assessment), activities of daily living (measured using the Barthel Activities of Daily Living Index), quality of life (measured using the Stroke Impact Scale), resource use costs and quality-adjusted life-years', ""upper limb functional recovery 'success"", ""Upper limb functional recovery 'success"", 'cost-effective', 'upper limb impairment, in performance of activities of daily living, and in mobility', 'upper limb impairment', 'activities of daily living (as measured by the Stroke Impact Scale activities of daily living domain', 'upper limb function', 'attrition rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4517873', 'cui_str': '770'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",770.0,0.042278,"The attrition rate was higher in the usual care group than in the robot-assisted training or enhanced upper limb therapy groups, and differential attrition is a potential source of bias.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rodgers', 'Affiliation': 'Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Bosomworth', 'Affiliation': 'Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Hermano I', 'Initials': 'HI', 'LastName': 'Krebs', 'Affiliation': 'Mechanical Engineering Department, Massachusetts Institute of Technology, Cambridge, MA, USA.'}, {'ForeName': 'Frederike', 'Initials': 'F', 'LastName': 'van Wijck', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Howel', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Finch', 'Affiliation': 'Nursing, Midwifery and Health, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Alvarado', 'Affiliation': 'School of Healthcare, University of Leeds, Leeds, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ternent', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fernandez-Garcia', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Aird', 'Affiliation': 'Stroke Northumbria, Northumbria Healthcare NHS Foundation Trust, North Tyneside, UK.'}, {'ForeName': 'Sreeman', 'Initials': 'S', 'LastName': 'Andole', 'Affiliation': 'Barking, Havering and Redbridge University Hospitals NHS Trust, Romford, UK.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Cohen', 'Affiliation': 'London North West University Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Dawson', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Ford', 'Affiliation': 'Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Francis', 'Affiliation': 'Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Hogg', 'Affiliation': 'Lay investigator (contact Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK).'}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Hughes', 'Affiliation': 'NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Price', 'Affiliation': 'Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Duncan L', 'Initials': 'DL', 'LastName': 'Turner', 'Affiliation': 'School of Health, Sport and Bioscience, University of East London, London, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wilkes', 'Affiliation': 'School of Medicine, University of Sunderland, Sunderland, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shaw', 'Affiliation': 'Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24540']
1815,33140841,Experiences of induction of labor with a catheter - a prospective randomized controlled trial comparing the outpatient and inpatient setting.,"INTRODUCTION
Approximately every fourth labor is induced. In Finland, when labor is induced, it is commonly carried out with a catheter in the inpatient (IP) setting. However, in uncomplicated, full-term pregnancies induction of labor (IOL) in the outpatient (OP) setting is also possible. Nevertheless, there is only a limited amount of information about the experiences of IOL in OP setting. Our study compared the experiences of catheter IOL in OP and IP settings.
MATERIAL AND METHODS
We performed a prospective randomized study, including 113 women with uncomplicated full-term pregnancies with planned IOL. After catheter insertion, women were randomized into OP or IP settings: after dropouts, there were 53 women in the OP group and 54 in the IP. The experiences of IOL were evaluated with three sets of visual analogue scale (VAS) questionnaires: the general experience (eight questions), the concurrent induction experience (1h, 5h, 9h, 13h; nine questions) and the postpartum experience questionnaire (14 questions).
RESULTS
Both groups had low VAS scores, indicating good experiences of IOL. Women in the OP group were less satisfied (mean VAS difference Δ=7.8, P=0.015) and more anxious (Δ=4.8, P=0.008) than women in the IP group. In the course of the IOL, all women became less satisfied (Δ= 8.4, P=0.001), had more contraction pain (Δ=8.9, P=0.020) and had a higher the frequency of contractions (Δ=9.9, P=0.004), but they were more relaxed and experienced less fear (Δ=6.9, P=0.036, Δ=5.3, P=0.001, respectively). There was no interaction between group and time. According to the postpartum experience questionnaire, both groups had a similar good general experience of IOL (P=0.736) but the OP group had more fear (Δ=9.5, P=0.009) and was more anxious (Δ=9.0, P=0.007). Most of the women would choose catheter IOL in a subsequent pregnancy (OP 82.6% and IP 87.0%).
CONCLUSIONS
The women in the OP setting were less satisfied and more anxious than the women in the IP setting. However, the differences were marginal and the general experience after IOL was good. IOL in an OP setting is thus a viable option in low-risk full-term pregnancies. Therefore, when using catheter IOL, both setting options should be available.",2020,"Women in the OP group were less satisfied (mean VAS difference Δ=7.8, P=0.015) and more anxious (Δ=4.8, P=0.008) than women in the IP group.",['113 women with uncomplicated full-term pregnancies with planned IOL'],[],"['frequency of contractions', 'visual analogue scale (VAS) questionnaires', 'low VAS scores', 'anxious', 'contraction pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}]",[],"[{'cui': 'C0233126', 'cui_str': 'Frequency of uterine contraction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",113.0,0.0284907,"Women in the OP group were less satisfied (mean VAS difference Δ=7.8, P=0.015) and more anxious (Δ=4.8, P=0.008) than women in the IP group.","[{'ForeName': 'Henna', 'Initials': 'H', 'LastName': 'Haavisto', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Polo-Kantola', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Anttila', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Kolari', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Ojala', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Rinne', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.14037']
1816,33140886,Pharmacological fMRI provides evidence for opioidergic modulation of discrimination of facial pain expressions.,"The endogenous opioid system is strongly involved in the modulation of pain. However, the potential role of this system in perceiving painful facial expressions from others has not been sufficiently explored as of yet. To elucidate the contribution of the opioid system to the perception of painful facial expressions, we conducted a double-blind, within-subjects pharmacological functional magnetic resonance imaging (fMRI) study, in which 42 participants engaged in an emotion discrimination task (pain vs. disgust expressions) in two experimental sessions, receiving either the opioid receptor antagonist naltrexone or an inert substance (placebo). On the behavioral level, participants less frequently judged an expression as pain under naltrexone as compared to placebo. On the neural level, parametric modulation of activation in the (putative) right fusiform face area (FFA), which was correlated with increased pain intensity, was higher under naltrexone than placebo. Regression analyses revealed that brain activity in the right FFA significantly predicted behavioral performance in disambiguating pain from disgust, both under naltrexone and placebo. These findings suggest that reducing opioid system activity decreased participants' sensitivity for facial expressions of pain, and that this was linked to possibly compensatory engagement of processes related to visual perception, rather than to higher level affective processes, and pain regulation.",2020,"Regression analyses revealed that brain activity in the right FFA significantly predicted behavioral performance in disambiguating pain from disgust, both under naltrexone and placebo.","['42 participants engaged in an emotion discrimination task (pain vs. disgust expressions) in two experimental sessions, receiving either the']","['placebo', 'opioid receptor antagonist naltrexone or an inert substance (placebo']","['behavioral performance', 'brain activity', 'neural level, parametric modulation of activation in the (putative) right fusiform face area (FFA', 'pain intensity']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0439861', 'cui_str': 'Substance'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0332493', 'cui_str': 'Fusiform shape'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",42.0,0.144321,"Regression analyses revealed that brain activity in the right FFA significantly predicted behavioral performance in disambiguating pain from disgust, both under naltrexone and placebo.","[{'ForeName': 'Yili', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rütgen', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}]",Psychophysiology,['10.1111/psyp.13717']
1817,33140989,Non-pharmacological anxiety reduction with immersive virtual reality for first-trimester dilation and curettage: a pilot study.,"OBJECTIVES
Most women experience moderate to severe pain during first-trimester surgical termination of pregnancy despite the application of various analgesic techniques. Studies have shown that virtual reality (VR) is effective in reducing anxiety among a range of women in differing circumstances. Our study objectives were to assess the feasibility of using VR during first-trimester dilation and curettage under local anaesthesia and understand the effect of VR on procedure-related anxiety during first-trimester dilation and curettage.
METHODS
A pilot feasibility study was conducted in a convenience sample of 30 women (15 in the intervention group and 15 in the control group). Anxiety scores were recorded before, during and after the procedure. In-depth interviews were conducted after the procedure.
RESULTS
Participants reported that VR was either very effective (53%) or somewhat effective (40%) in relieving anxiety during and after the procedure. Eleven participants used the VR device for the entire procedure and four participants removed it during the procedure. The anxiety scores before the procedure were not significantly different between the groups. The intervention group had a median five point post-procedure decrease in anxiety score rated on a visual analogue scale, which was significantly different from that of the control group. Overall, participants had a positive experience but there were some technological frustrations.
CONCLUSION
Women undergoing dilation and curettage in the first trimester were able to use a VR device during the procedure. VR-induced distraction and relaxation helped to reduce anxiety in some participants both during and after the procedure.",2020,"The intervention group had a median five point post-procedure decrease in anxiety score rated on a visual analogue scale, which was significantly different from that of the control group.",['convenience sample of 30 women (15 in the intervention group and 15 in the control group'],"['VR-induced distraction and relaxation', 'immersive virtual reality', 'virtual reality (VR']","['Anxiety scores', 'anxiety', 'anxiety scores', 'anxiety score rated on a visual analogue scale', 'VR device', 'relieving anxiety']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}]",30.0,0.0416512,"The intervention group had a median five point post-procedure decrease in anxiety score rated on a visual analogue scale, which was significantly different from that of the control group.","[{'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Sridhar', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Shiliang', 'Affiliation': 'David Geffen School of Medicine, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Woodson', 'Affiliation': 'David Geffen School of Medicine, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Kwan', 'Affiliation': 'Department of Urology, University of California, Los Angeles, CA, USA.'}]",The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception,['10.1080/13625187.2020.1836146']
1818,33141101,Twelve-Week Internet-Based Individualized Exercise Program in Adults With Systemic Lupus Erythematosus: Protocol for a Randomized Controlled Trial.,"BACKGROUND
Systemic lupus erythematosus is a systemic autoimmune disease, which is associated with high cardiovascular risk, a predisposition to metabolic disorders, muscle wasting, and fatigue. Exercise therapy has become an important part of the long-term treatment of comorbidities in systemic lupus erythematosus. Exercise can lead to various benefits in patients with systemic lupus erythematosus such as increased aerobic capacity and exercise tolerance, resulting in an increased quality of life, decreased depression, and decreased fatigue. At the moment, no evidence-based treatment guidelines that recommend exercise for patients with systemic lupus erythematosus exist. Also, the efficacy of different training programs requires further investigation.
OBJECTIVE
This study focuses on the feasibility, efficacy, and safety of an internet-based exercise program in patients with systemic lupus erythematosus. Furthermore, we investigate the feasibility and efficiency of anaerobic training compared to aerobic training.
METHODS
Overall, patients with systemic lupus erythematosus from the Division of Nephrology, Rheumatology, and Immunology outpatient clinic of the University Medical Center Mainz who are clinically stable status are included and randomized in an aerobic exercise group (n=10), anaerobic exercise group (n=10), or treatment as usual group (n=10). After completing initial clinical testing and physical fitness tests, patients undergo supervised 12-week online exercise programs, receiving weekly individualized training plans adapted to their physical performance. The primary outcome is change in physical fitness (VO2 peak) after 12 weeks compared to baseline. Secondary outcomes are disease activity measured via laboratory results (complement, autoantibodies) and questionnaires, as well as changes in muscle mass (anaerobic exercise group), results of the Chair-Stand test, and measurements of circulating cell-free DNA and extracellular vesicles.
RESULTS
The study was registered in May 2019. Enrollment began in May 2019. Of 40 patients who were initially screened, 30 patients fulfilled the inclusion criteria and were included in the study; 1 participant withdrew prior to the start of the exercise program. Among the 25 patients who completed the study, no serious adverse events have been reported; 3 participants withdrew during the program (due to frequent colds, n=1; Crohn relapse, n=1; physical strain, n=1), and 1 participant has not yet completed the program. Data analysis is ongoing, and results are expected to be submitted for publication in January 2021.
CONCLUSIONS
We expect the online exercise intervention to be a feasible and efficient tool to provide regular individualized exercise for patients with systemic lupus erythematosus.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03942718; http://clinicaltrials.gov/ct2/show/NCT03942718.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/18291.",2020,"We expect the online exercise intervention to be a feasible and efficient tool to provide regular individualized exercise for patients with systemic lupus erythematosus.
","['40 patients who were initially screened, 30 patients fulfilled the inclusion criteria and were included in the study; 1 participant withdrew prior to the start of the exercise program', 'Adults With Systemic Lupus Erythematosus', 'patients with systemic lupus erythematosus', 'patients with systemic lupus erythematosus from the Division of Nephrology, Rheumatology, and Immunology outpatient clinic of the University Medical Center Mainz who are clinically stable status', 'patients with systemic lupus erythematosus exist', '25 patients']","['Twelve-Week Internet-Based Individualized Exercise Program', 'online exercise intervention', 'anaerobic training', 'anaerobic exercise', 'aerobic exercise', 'internet-based exercise program', 'Exercise therapy']","['feasibility, efficacy, and safety', 'aerobic capacity and exercise tolerance', 'disease activity measured via laboratory results (complement, autoantibodies) and questionnaires, as well as changes in muscle mass (anaerobic exercise group), results of the Chair-Stand test, and measurements of circulating cell-free DNA and extracellular vesicles', 'change in physical fitness (VO2 peak']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0004358', 'cui_str': 'Autoantibody'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4289789', 'cui_str': 'Cell free DNA'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",,0.0821693,"We expect the online exercise intervention to be a feasible and efficient tool to provide regular individualized exercise for patients with systemic lupus erythematosus.
","[{'ForeName': 'Simone Cosima', 'Initials': 'SC', 'LastName': 'Boedecker', 'Affiliation': 'Department of Rheumatology and Nephrology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Keito Finn Akanby', 'Initials': 'KFA', 'LastName': 'Philippi', 'Affiliation': 'Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Elmo', 'Initials': 'E', 'LastName': 'Neuberger', 'Affiliation': 'Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pfirrmann', 'Affiliation': 'Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Haller', 'Affiliation': 'Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schwarting', 'Affiliation': 'Department of Rheumatology and Nephrology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Perikles', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Weinmann-Menke', 'Affiliation': 'Department of Rheumatology and Nephrology, University Medical Center Mainz, Mainz, Germany.'}]",JMIR research protocols,['10.2196/18291']
1819,33141102,"Effect of Pain Education and Exercise on Pain and Function in Chronic Achilles Tendinopathy: Protocol for a Double-Blind, Placebo-Controlled Randomized Trial.","BACKGROUND
Achilles tendinopathy (AT) rehabilitation traditionally includes progressive tendon loading exercises. Recent evidence suggests a biopsychosocial approach that incorporates patient education on psychosocial factors and mechanisms of pain can reduce pain and disability in individuals with chronic pain. This is yet to be examined in individuals with AT.
OBJECTIVE
This study aims to compare the effects on movement-evoked pain and self-reported function of pain education as part of a biopsychosocial approach with pathoanatomical education for people with AT when combined with a progressive tendon loading exercise program.
METHODS
A single-site, randomized, double-blind, placebo-controlled clinical trial will be conducted in a university-based hospital in a laboratory setting and/or by telehealth. A total of 66 participants with chronic (>3 months) midportion or insertional AT will be randomized for the Tendinopathy Education of the Achilles (TEAch) study. All participants will complete progressive Achilles tendon loading exercises over 12 weeks and will be encouraged to continue with self-selected exercises as tolerated. All participants will complete 6-7 one-to-one sessions with a physical therapist to progress exercises in a standardized manner over 8 weeks. During the last 4 weeks of the intervention, participants will be encouraged to maintain their home exercise program. Participants will be randomized to 1 of 2 types of education (pain education or pathoanatomic), in addition to exercise. Pain education will focus on the biological and psychological mechanisms of pain within a biopsychosocial framing of AT. Pathoanatomic education will focus on biological processes within a more traditional biomedical framework of AT. Evaluation sessions will be completed at baseline and 8-week follow-up, and self-reported outcome measures will be completed at the 12-week follow-up. Both groups will complete progressive Achilles loading exercises in 4 phases throughout the 12 weeks and will be encouraged to continue with self-selected exercises as tolerated. Primary outcomes are movement-evoked pain during heel raises and self-reported function (patient-reported outcome measure information system-Physical Function). Secondary outcomes assess central nervous system nociceptive processing, psychological factors, motor function, and feasibility.
RESULTS
Institutional review board approval was obtained on April 15, 2019, and study funding began in July 2019. As of March 2020, we randomized 23 out of 66 participants. In September 2020, we screened 267 individuals, consented 68 participants, and randomized 51 participants. We anticipate completing the primary data analysis by March 2022.
CONCLUSIONS
The TEAch study will evaluate the utility of pain education for those with AT and the effects of improved patient knowledge on pain, physical function, and clinical outcomes.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/19111.",2020,Both groups will complete progressive Achilles loading exercises in 4 phases throughout the 12 weeks and will be encouraged to continue with self-selected exercises as tolerated.,"['individuals with chronic pain', 'people with AT when combined with a progressive tendon loading exercise program', 'In September 2020, we screened 267 individuals, consented 68 participants, and randomized 51 participants', 'individuals with AT', '66 participants', '66 participants with chronic (>3 months) midportion or insertional AT', 'Chronic Achilles Tendinopathy', 'a university-based hospital in a laboratory setting and/or by telehealth']","['education (pain education or pathoanatomic), in addition to exercise', 'physical therapist to progress exercises', 'placebo', 'Placebo', 'Pain Education and Exercise']","['central nervous system nociceptive processing, psychological factors, motor function, and feasibility', 'pain and disability', 'pain, physical function, and clinical outcomes', 'Pain and Function', 'movement-evoked pain during heel raises and self-reported function (patient-reported outcome measure information system-Physical Function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3838864', 'cui_str': 'Insertional Achilles tendinopathy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0021428', 'cui_str': 'Information system'}]",51.0,0.25608,Both groups will complete progressive Achilles loading exercises in 4 phases throughout the 12 weeks and will be encouraged to continue with self-selected exercises as tolerated.,"[{'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Post', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Ebonie K', 'Initials': 'EK', 'LastName': 'Rio', 'Affiliation': 'School of Allied Health, La Trobe University, Bundoora, Australia.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Sluka', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'G Lorimer', 'Initials': 'GL', 'LastName': 'Moseley', 'Affiliation': 'IMPACT in Health, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Emine O', 'Initials': 'EO', 'LastName': 'Bayman', 'Affiliation': 'Departments of Biostatistics and Anesthesia, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Mederic M', 'Initials': 'MM', 'LastName': 'Hall', 'Affiliation': 'University of Iowa Sports Medicine, Department of Orthopaedics & Rehabilitation, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'de Cesar Netto', 'Affiliation': 'Department of Orthopaedics & Rehabiliation, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Wilken', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Jessica F', 'Initials': 'JF', 'LastName': 'Danielson', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Chimenti', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Iowa, Iowa City, IA, United States.'}]",JMIR research protocols,['10.2196/19111']
1820,33141103,Efficacy of an Online Physical Activity Intervention Coordinated With Routine Clinical Care: Protocol for a Pilot Randomized Controlled Trial.,"BACKGROUND
Most adults are not achieving recommended levels of physical activity (150 minutes/week, moderate-to-vigorous intensity). Inadequate activity levels are associated with numerous poor health outcomes, and clinical recommendations endorse physical activity in the front-line treatment of obesity, diabetes, dyslipidemia, and hypertension. A framework for physical activity prescription and referral has been developed, but has not been widely implemented. This may be due, in part, to the lack of feasible and effective physical activity intervention programs designed to coordinate with clinical care delivery.
OBJECTIVE
This manuscript describes the protocol for a pilot randomized controlled trial (RCT) that tests the efficacy of a 13-week online intervention for increasing physical activity in adult primary care patients (aged 21-70 years) reporting inadequate activity levels. The feasibility of implementing specific components of a physical activity clinical referral program, including screening for low activity levels and reporting patient program success to referring physicians, will also be examined. Analyses will include participant perspectives on maintaining physical activity.
METHODS
This pilot study includes a 3-month wait-listed control RCT (1:1 ratio within age strata 21-54 and 55-70 years). After the RCT primary end point at 3 months, wait-listed participants are offered the full intervention and all participants are followed to 6 months after starting the intervention program. Primary RCT outcomes include differences across randomized groups in average step count, moderate-to-vigorous physical activity, and sedentary behavior (minutes/day) derived from accelerometers. Maintenance of physical activity changes will be examined for all participants at 6 months after the intervention start.
RESULTS
Recruitment took place between October 2018 and May 2019 (79 participants were randomized). Data collection was completed in February 2020. Primary data analyses are ongoing.
CONCLUSIONS
The results of this study will inform the development of a clinical referral program for physical activity improvement that combines an online intervention with clinical screening for low activity levels, support for postintervention behavior maintenance, and feedback to the referring physician.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03695016; https://clinicaltrials.gov/ct2/show/NCT03695016.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/18891.",2020,"The results of this study will inform the development of a clinical referral program for physical activity improvement that combines an online intervention with clinical screening for low activity levels, support for postintervention behavior maintenance, and feedback to the referring physician.
","['adult primary care patients (aged 21-70 years) reporting inadequate activity levels', 'Recruitment took place between October 2018 and May 2019 (79 participants were randomized', '1:1 ratio within age strata 21-54 and 55-70 years']","['wait-listed control RCT', 'Online Physical Activity Intervention', '13-week online intervention']","['physical activity changes', 'average step count, moderate-to-vigorous physical activity, and sedentary behavior (minutes/day) derived from accelerometers', 'physical activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0556973', 'cui_str': 'mins/day'}]",79.0,0.0816296,"The results of this study will inform the development of a clinical referral program for physical activity improvement that combines an online intervention with clinical screening for low activity levels, support for postintervention behavior maintenance, and feedback to the referring physician.
","[{'ForeName': 'Bonny', 'Initials': 'B', 'LastName': 'Rockette-Wagner', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Fischer', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Kriska', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Conroy', 'Affiliation': 'Division of General Internal Medicine, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Roumpz', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'McTigue', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States.'}]",JMIR research protocols,['10.2196/18891']
1821,33141209,Effect of an Online Weight Management Program Integrated With Population Health Management on Weight Change: A Randomized Clinical Trial.,"Importance
Online programs may help with weight loss but have not been widely implemented in routine primary care.
Objective
To compare the effectiveness of a combined intervention, including an online weight management program plus population health management, with the online program only and with usual care.
Design, Setting, and Participants
Cluster randomized trial with enrollment from July 19, 2016, through August 10, 2017, at 15 primary care practices in the US. Eligible participants had a scheduled primary care visit and were aged 20 to 70 years, had a body mass index between 27 and less than 40, and had a diagnosis of hypertension or type 2 diabetes. Follow-up ended on May 8, 2019.
Interventions
Participants in the usual care group (n = 326) were mailed general information about weight management. Participants in the online program only group (n = 216) and the combined intervention group (n = 298) were registered for the online program. The participants in the combined intervention group also received weight-related population health management, which included additional support from nonclinical staff who monitored their progress in the online program and conducted periodic outreach.
Main Outcomes and Measures
The primary outcome was weight change at 12 months based on measured weights recorded in the electronic health record. Weight change at 18 months was a secondary outcome.
Results
Among the 840 participants who enrolled (mean age, 59.3 years [SD, 8.6 years]; 60% female; 76.8% White), 732 (87.1%) had a recorded weight at 12 months and the missing weights for the remaining participants were imputed. There was a significant difference in weight change at 12 months by group with a mean weight change of -1.2 kg (95% CI, -2.1 to -0.3 kg) in the usual care group, -1.9 kg (95% CI, -2.6 to -1.1 kg) in the online program only group, and -3.1 kg (95% CI, -3.7 to -2.5 kg) in the combined intervention group (P < .001). The difference in weight change between the combined intervention group and the usual care group was -1.9 kg (97.5% CI, -2.9 to -0.9 kg; P < .001) and the difference between the combined intervention group and the online program only group was -1.2 kg (95% CI, -2.2 to -0.3 kg; P = .01). At 18 months, the mean weight change was -1.9 kg (95% CI, -2.8 to -1.0 kg) in the usual care group, -1.1 kg (95% CI, -2.0 to -0.3 kg) in the online program only group, and -2.8 kg (95% CI, -3.5 to -2.0 kg) in the combined intervention group (P < .001).
Conclusions and Relevance
Among primary care patients with overweight or obesity and hypertension or type 2 diabetes, combining population health management with an online program resulted in a small but statistically significant greater weight loss at 12 months compared with usual care or the online program only. Further research is needed to understand the generalizability, scalability, and durability of these findings.
Trial Registration
ClinicalTrials.gov Identifier: NCT02656693.",2020,"There was a significant difference in weight change at 12 months by group with a mean weight change of -1.2 kg (95% CI, -2.1 to -0.3 kg) in the usual care group, -1.9 kg (95% CI, -2.6 to -1.1 kg) in the online program only group, and -3.1 kg (95% CI, -3.7 to -2.5 kg) in the combined intervention group (P < .001).","['Participants\n\n\nCluster randomized trial with enrollment from July 19, 2016, through August 10, 2017, at 15 primary care practices in the US', 'primary care patients with overweight or obesity and hypertension or type 2 diabetes', '840 participants who enrolled (mean age, 59.3 years [SD, 8.6 years]; 60% female; 76.8% White), 732 (87.1%) had a recorded weight at 12 months and the missing weights for the remaining participants were imputed', 'Eligible participants had a scheduled primary care visit and were aged 20 to 70 years, had a body mass index between 27 and less than 40, and had a diagnosis of hypertension or type 2 diabetes', 'Interventions\n\n\nParticipants in the usual care group (n\u2009=\u2009326) were']","['mailed general information about weight management', 'Online Weight Management Program Integrated With Population Health Management', 'online weight management program plus population health management, with the online program only and with usual care', 'weight-related population health management, which included additional support from nonclinical staff who monitored their progress in the online program and conducted periodic outreach']","['mean weight change', 'Weight Change', 'weight loss', 'weight change', 'Weight change']","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191353', 'cui_str': '326'}]","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C4704688', 'cui_str': 'Population Health Management'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.111055,"There was a significant difference in weight change at 12 months by group with a mean weight change of -1.2 kg (95% CI, -2.1 to -0.3 kg) in the usual care group, -1.9 kg (95% CI, -2.6 to -1.1 kg) in the online program only group, and -3.1 kg (95% CI, -3.7 to -2.5 kg) in the combined intervention group (P < .001).","[{'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Baer', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Rozenblum', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'De La Cruz', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wien', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Nyryan V', 'Initials': 'NV', 'LastName': 'Nolido', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Metzler', 'Affiliation': ""Center for Clinical Investigation, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'McManus', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Florencia', 'Initials': 'F', 'LastName': 'Halperin', 'Affiliation': 'Harvard Medical School, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Aronne', 'Affiliation': 'Intellihealth Inc, San Francisco, California.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Minero', 'Affiliation': 'Intellihealth Inc, San Francisco, California.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Block', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Bates', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA,['10.1001/jama.2020.18977']
1822,33141524,Feasibility of Early Active Rehabilitation for Concussion Recovery in Youth: A Randomized Trial.,"OBJECTIVE
The primary objective is to evaluate the feasibility (safety and acceptability) of implementing early active rehabilitation (AR) for concussion management in youth with symptoms persisting 2 weeks after injury. A secondary and exploratory objective was to estimate the potential efficacy of early AR compared with standard AR. We hypothesize that AR at 2-weeks postconcussion will be safe and acceptable to patients.
DESIGN
Randomized clinical trial.
SETTING
The Montreal Children's Hospital of the McGill University Health Center (MCH-MUHC), a tertiary care pediatric teaching hospital affiliated with McGill University in Montreal, Canada.
PARTICIPANTS
Twenty youth aged 9 to 17 years old with postconcussion symptoms for at least 2 weeks.
INTERVENTION
Active rehabilitation (aerobic exercise, coordination drills, visualization, and education/reassurance) was administered by physiotherapists in-person, and then continued as a home program.
METHODS
Twenty participants were randomized to either early AR (initiated 2 weeks after injury) or standard AR (initiated 4 weeks after injury).
RESULTS
Two adverse events (one in each group) were identified through an online survey more than one-month postconcussion. Postconcussion symptoms decreased over time for both groups.
CONCLUSIONS
The results from this pilot study indicate that a full clinical trial estimating the efficacy of early AR (starting 2 weeks after injury) is feasible. Further study is needed to determine the superiority of this strategy over current treatment approaches.",2020,"Postconcussion symptoms decreased over time for both groups.
","['youth with symptoms persisting 2 weeks after injury', 'Twenty participants', 'Twenty youth aged 9 to 17 years old with postconcussion symptoms for at least 2 weeks', 'Youth', ""The Montreal Children's Hospital of the McGill University Health Center (MCH-MUHC), a tertiary care pediatric teaching hospital affiliated with McGill University in Montreal, Canada""]","['standard AR', 'Active rehabilitation (aerobic exercise, coordination drills, visualization, and education/reassurance', 'implementing early active rehabilitation (AR', 'Early Active Rehabilitation']","['Postconcussion symptoms', 'feasibility (safety and acceptability']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0204558', 'cui_str': 'Group reassurance'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",20.0,0.139988,"Postconcussion symptoms decreased over time for both groups.
","[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Dobney', 'Affiliation': ""*School of Physical and Occupational Therapy, Faculty of Medicine, McGill University, Montreal, QC, Canada; †Trauma Centre, The Montreal Children's Hospital, McGill University Health Center, Montreal, QC, Canada; ‡Canadian Hospitals Injury Reporting and Prevention Program, Government of Canada, Ottawa, Canada; §Department of Pediatric Surgery, Faculty of Medicine, McGill University, Montreal, QC, Canada; ¶Schools of Physical and Occupational Therapy, Communication Sciences and Disorders, Nursing, Faculty of Medicine McGill University, Montreal, QC, Canada; ║Department of Pediatrics, Faculty of Medicine, McGill University, Montreal, QC, Canada; and **Departments of Pediatric Emergency Medicine, Faculty of Medicine, McGill University, Montreal, QC, Canada.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Grilli', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Beaulieu', 'Affiliation': ''}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Straub', 'Affiliation': ''}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Galli', 'Affiliation': ''}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Saklas', 'Affiliation': ''}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Friedman', 'Affiliation': ''}, {'ForeName': 'Alexander Sasha', 'Initials': 'AS', 'LastName': 'Dubrovsky', 'Affiliation': ''}, {'ForeName': 'Isabelle J', 'Initials': 'IJ', 'LastName': 'Gagnon', 'Affiliation': ''}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000671']
1823,33136422,Cognitive behavioral therapy (CBT) and pain education for people with chronic pain: Tests of treatment mechanisms.,"OBJECTIVES
The goals of the study were to determine to what degree changes in pain-related cognition during cognitive behavioral treatment (CBT) and pain education (EDU) represented treatment mechanisms and whether these cognitive changes worked to a larger extent to produce favorable outcomes in CBT than in EDU.
METHOD
Reported here are secondary analyses of a randomized control trial (N = 290) comparing CBT, EDU, and treatment as usual for low-literacy, low-socioeconomic-status people with chronic pain. We excluded the treatment as usual condition from these analyses and included measures collected at a midtreatment epoch. Treatment was 10 weekly group sessions.
RESULTS
Linear mixed models revealed nonsignificant differences in pre- to mid- to posttreatment changes in pain catastrophizing and pain self-efficacy between CBT and EDU. The same was true for outcome measures. Cross-lagged analyses revealed significant relationships between pre- to midtreatment changes in catastrophizing and self-efficacy and mid- to posttreatment changes in outcomes. However, relationships between pre- to midtreatment changes in outcomes and mid- to posttreatment changes in catastrophizing and self-efficacy were also significant.
CONCLUSIONS
Results suggest a complex set of mechanistic relationships. Instead of a unidirectional path from designated mechanism to designated outcome, our results suggest reciprocal influences whereby cognitive changes may beget outcome improvements and vice versa. Results also suggest that cognitive changes do not occur solely in a treatment that uses cognitive restructuring to foster such changes but may occur as a function of providing people with detailed information regarding the biopsychosocial nature of chronic pain. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"RESULTS
Linear mixed models revealed nonsignificant differences in pre- to mid- to posttreatment changes in pain catastrophizing and pain self-efficacy between CBT and EDU.","['people with chronic pain', 'status people with chronic pain']","['Cognitive behavioral therapy (CBT) and pain education', 'CBT, EDU, and treatment as usual for low-literacy, low-socioeconomic']","['catastrophizing and self-efficacy', 'pain catastrophizing and pain self-efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0440559,"RESULTS
Linear mixed models revealed nonsignificant differences in pre- to mid- to posttreatment changes in pain catastrophizing and pain self-efficacy between CBT and EDU.","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Burns', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Van Dyke', 'Affiliation': 'Department of Psychology, Young Harris College.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology, University of Alabama, Tuscaloosa.'}, {'ForeName': 'Calia A', 'Initials': 'CA', 'LastName': 'Morais', 'Affiliation': 'Department of Community Dentistry and Behavioral Science, Pain Research and Intervention Center of Excellence, University of Florida.'}, {'ForeName': 'Beverly E', 'Initials': 'BE', 'LastName': 'Thorn', 'Affiliation': 'Department of Psychology, University of Alabama, Tuscaloosa.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000612']
1824,33136423,Supporting Teen Problem-Solving (STEPS) 3 year outcomes: Preventing diabetes-specific emotional distress and depressive symptoms in adolescents with type 1 diabetes.,"OBJECTIVE
This article reports the 3-year outcomes for the Supporting Teen Problem-Solving (STePS) multisite Randomized Control Trial (RCT); reporting the overall impact of the STePS trial, and the differential impact of each arm of the trial (a resilience promoting intervention [PRP T1D] vs. a diabetes education intervention [EI]) on diabetes-specific emotional distress and depressive symptoms.
METHOD
Participants included 264 adolescents with Type 1 diabetes (T1D), ages 14-18, in Chicago and San Francisco. Both intervention arms lasted 4.5 months and assessments were conducted at baseline, postintervention (4.5 months), and 5 follow-up visits (8, 12, 16, 28, and 40 months from baseline). Intervention efficacy was investigated using latent growth curve modeling (LGCM) to analyze the rate and shape of change of outcomes from preintervention across postintervention and follow-up time points.
RESULTS
Mean age of participants was 15.7 years, mean T1D duration was 6.9 years, mean HbA1c at baseline was 9.1%. The sample was diverse with nearly 35% identifying as racial or ethnic minorities, and 60% were female. PRP T1D participants reported significantly lower diabetes distress compared with EI participants, and the effect size increased over time. For the pooled sample, while 40% of youth reported elevated distress at baseline, only 23% reported elevated distress 3 years postintervention. Moreover, PRP T1D participants experienced a significant decline in depressive symptoms from 16 to 40 months postbaseline, while participants in the education arm did not.
CONCLUSIONS
Results from the 3-year outcomes assessment demonstrate the robust effects of PRP T1D in adolescents with declines in distress and depressive symptoms. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"T1D participants reported significantly lower diabetes distress compared with EI participants, and the effect size increased over time.","['adolescents with type 1 diabetes', 'Participants included 264 adolescents with Type 1 diabetes (T1D), ages 14-18, in Chicago and San Francisco', 'adolescents with declines in distress and depressive symptoms', 'Mean age of participants was 15.7 years, mean T1D duration was 6.9 years, mean HbA1c at baseline was 9.1', 'sample was diverse with nearly 35% identifying as racial or ethnic minorities, and 60% were female', 'diabetes-specific emotional distress and depressive symptoms']","['PRP', 'diabetes education intervention [EI', 'latent growth curve modeling (LGCM']","['Intervention efficacy', 'diabetes distress', 'depressive symptoms', 'elevated distress', 'diabetes-specific emotional distress and depressive symptoms', 'effect size increased over time']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]","[{'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1268652', 'cui_str': 'Increase in size since previous mammogram'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",264.0,0.105475,"T1D participants reported significantly lower diabetes distress compared with EI participants, and the effect size increased over time.","[{'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Weissberg-Benchell', 'Affiliation': ""Pritzker Department of Psychiatry and Behavioral Health, Ann & Robert H. Lurie Children's Hospital of Chicago.""}, {'ForeName': 'Jenna B', 'Initials': 'JB', 'LastName': 'Shapiro', 'Affiliation': ""Pritzker Department of Psychiatry and Behavioral Health, Ann & Robert H. Lurie Children's Hospital of Chicago.""}, {'ForeName': 'Fred B', 'Initials': 'FB', 'LastName': 'Bryant', 'Affiliation': 'Department of Psychology, Loyola University Chicago.'}, {'ForeName': 'Korey K', 'Initials': 'KK', 'LastName': 'Hood', 'Affiliation': 'Department of Pediatrics, Stanford University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000608']
1825,33136471,Randomized Phase III Study of Irinotecan Plus Cisplatin Versus Etoposide Plus Cisplatin for Completely Resected High-Grade Neuroendocrine Carcinoma of the Lung: JCOG1205/1206.,"PURPOSE
To verify the superiority of irinotecan plus cisplatin over etoposide plus cisplatin as postoperative adjuvant chemotherapy for patients with pathologic stage I-IIIA, completely resected, high-grade neuroendocrine carcinoma (HGNEC) of the lung.
METHODS
This was a randomized, open-label, phase III study on patients with completely resected stage I-IIIA HGNEC of the lung. They were randomly assigned to receive either etoposide (100 mg/m 2 , days 1-3) plus cisplatin (80 mg/m 2 , day 1) or irinotecan (60 mg/m 2 , days 1, 8, 15) plus cisplatin (60 mg/m 2 , day 1) up to four cycles. The primary end point was relapse-free survival (RFS) in the intention-to-treat population. This trial was registered with the Japan Registry of Clinical Trials (jRCTs031180216).
RESULTS
Between April 2013 and October 2018, 221 patients were enrolled (etoposide plus cisplatin arm, 111 patients; irinotecan plus cisplatin arm, 110 patients). In the second interim analysis, early termination of the trial was recommended because of futility. At a median follow-up of 24.1 months, the 3-year RFS was 65.4% for etoposide plus cisplatin and 69.0% for irinotecan plus cisplatin, with a hazard ratio of 1.076 (95% CI, 0.666 to 1.738; one-sided log-rank P = .619). Grade 3-4 adverse events were more frequent in the etoposide plus cisplatin arm, with febrile neutropenia (20% of 109 patients v 4% of 107 patients) and neutropenia (97% v 36%) being the most common. Meanwhile, grade 3-4 anorexia (6% v 11%) and diarrhea (1% v 8%) were more frequently observed in the irinotecan plus cisplatin arm.
CONCLUSION
Irinotecan plus cisplatin is not superior to etoposide plus cisplatin for improving RFS in patients with completely resected HGNEC; thus, etoposide plus cisplatin remains the standard treatment.",2020,"Irinotecan plus cisplatin is not superior to etoposide plus cisplatin for improving RFS in patients with completely resected HGNEC; thus, etoposide plus cisplatin remains the standard treatment.","['patients with completely resected stage I-IIIA HGNEC of the lung', 'arm, 110 patients', 'Completely Resected High-Grade Neuroendocrine Carcinoma of the Lung', 'patients with pathologic stage I-IIIA, completely resected, high-grade neuroendocrine carcinoma (HGNEC) of the lung', 'Between April 2013 and October 2018, 221 patients were enrolled ', 'patients with completely resected HGNEC', '111 patients']","['irinotecan plus cisplatin over etoposide plus cisplatin', 'cisplatin ', 'Irinotecan Plus Cisplatin Versus Etoposide Plus Cisplatin', 'cisplatin', 'Irinotecan plus cisplatin', 'etoposide plus cisplatin', 'etoposide', 'irinotecan plus cisplatin', 'irinotecan']","['Grade 3-4 adverse events', 'febrile neutropenia', 'diarrhea', 'relapse-free survival (RFS', 'Meanwhile, grade 3-4 anorexia', 'neutropenia', '3-year RFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0206695', 'cui_str': 'Neuroendocrine carcinoma'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1320480', 'cui_str': 'Pathologic stage'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}]",221.0,0.117028,"Irinotecan plus cisplatin is not superior to etoposide plus cisplatin for improving RFS in patients with completely resected HGNEC; thus, etoposide plus cisplatin remains the standard treatment.","[{'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Kenmotsu', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho Sunto-gun, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Niho', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Wakabayashi', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Genichiro', 'Initials': 'G', 'LastName': 'Ishii', 'Affiliation': 'Division of Pathology, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Daga', 'Affiliation': 'Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Haruhiro', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Keiju', 'Initials': 'K', 'LastName': 'Aokage', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho Sunto-gun, Japan.'}, {'ForeName': 'Toshi', 'Initials': 'T', 'LastName': 'Menju', 'Affiliation': 'Department of Thoracic Surgery, Graduate School of Medicine, Kyoto University.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kasai', 'Affiliation': 'Division of Thoracic Oncology, Tochigi Cancer Center, Utsunomiya, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Yoshino', 'Affiliation': 'Department of General Thoracic Surgery, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Minato', 'Affiliation': 'Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota, Japan.'}, {'ForeName': 'Morihito', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Eba', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Asamura', 'Affiliation': 'Division of Thoracic Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Shun-Ichi', 'Initials': 'SI', 'LastName': 'Watanabe', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center Hospital, Tokyo, Japan.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01806']
1826,33136517,Correction to: Renal and Cardiovascular Effects of SGLT2 Inhibition in Combination with Loop Diuretics in Patients with Type 2 Diabetes and Chronic Heart Failure: The RECEDE-CHF Trial.,,2020,,['Patients with Type 2 Diabetes and Chronic Heart Failure'],['SGLT2 Inhibition in Combination with Loop Diuretics'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C1505133', 'cui_str': 'SLC5A2 protein, human'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0354100', 'cui_str': 'Loop diuretic'}]",[],,0.0282453,,[],Circulation,['10.1161/CIR.0000000000000934']
1827,33144370,Oral prednisolone for acute lower respiratory tract infection in clinically unrecognised asthma: an exploratory analysis of the Oral Steroids for Acute Cough (OSAC) randomised controlled trial.,"BACKGROUND
Acute lower respiratory tract infection (ALRTI) is often treated in primary care with antibiotics. The recent Oral Steroids for Acute Cough (OSAC) randomised controlled trial (RCT) showed corticosteroids were not an effective alternative in adults without a diagnosis of asthma with ALRTI.
AIM
To investigate if corticosteroids are beneficial for ALRTI in patients with unrecognised asthma.
DESIGN & SETTING
An exploratory analysis was undertaken of the primary care OSAC trial.
METHOD
A subgroup analysis was performed in patients who responded 'yes' to the following International Primary Care Airways Group (IPCAG) question: did you have wheeze and/or at least two of nocturnal cough or chest tightness or dyspnoea in the past year. Sensitivity analyses were carried out on those who answered 'yes' to wheeze and at least two of the nocturnal symptoms. The primary outcomes were as follows: duration of cough (0-28 days, minimum clinically important difference [MCID] of 3.79 days) and mean symptom severity score (range 0-6; MCID 1.66 units).
RESULTS
In total, 40 (10%) patients were included in the main analysis: mean age 49 years (standard deviation [SD] = 17.9), 52% male. Median cough duration was 3 days in both prednisolone (interquartile range [IQR] = 2-6 days) and placebo (IQR = 1-6 days) groups (adjusted hazard ratio [HR] = 1.10; 95% confidence interval [CI] = 0.47 to 2.54; P = 0.83), equating to 0.24 days longer in the prednisolone group (95% CI = 1.23 days shorter to 2.88 days longer). Mean symptom severity difference was -0.14 (95% CI = -0.78 to 0.49; P =0.65) comparing prednisolone with placebo. Similar findings were found in the sensitivity analysis.
CONCLUSION
No evidence was found to support the use of corticosteroids for ALRTI in patients with clinically unrecognised asthma. Clinicians should not use the IPCAG questions to target oral corticosteroid treatment in patients with ALRTI.",2020,No evidence was found to support the use of corticosteroids for ALRTI in patients with clinically unrecognised asthma.,"['patients with clinically unrecognised asthma', 'clinically unrecognised asthma', 'In total, 40 (10%) patients were included in the main analysis', 'adults without a diagnosis of asthma with ALRTI', ""patients who responded 'yes' to the following International Primary Care Airways Group (IPCAG) question: did you have wheeze"", 'patients with unrecognised asthma', 'patients with ALRTI', 'mean age 49 years (standard deviation [SD] = 17.9), 52% male']","['corticosteroids', 'Oral prednisolone', 'placebo', 'prednisolone']","['mean symptom severity score', 'nocturnal cough or chest tightness or dyspnoea', 'Mean symptom severity difference', 'Median cough duration', 'duration of cough']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231912', 'cui_str': 'Nocturnal cough'}, {'cui': 'C0232292', 'cui_str': 'Tight chest'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.439334,No evidence was found to support the use of corticosteroids for ALRTI in patients with clinically unrecognised asthma.,"[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Hawkey', 'Affiliation': 'Center for Academic Primary Care, National Institute for Health Research (NIHR) School for Primary Care Research, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care and Population Science, NIHR School for Primary Care Research, Aldermoor Health Centre, University of Southampton, Southampton, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care and Population Science, NIHR School for Primary Care Research, Aldermoor Health Centre, University of Southampton, Southampton, UK.'}, {'ForeName': 'Alastair D', 'Initials': 'AD', 'LastName': 'Hay', 'Affiliation': 'Center for Academic Primary Care, National Institute for Health Research (NIHR) School for Primary Care Research, Bristol Medical School, University of Bristol, Bristol, UK alastair.hay@bristol.ac.uk.'}]",BJGP open,['10.3399/bjgpopen20X101099']
1828,33144386,Immediate Effects and Safety of High-Frequency Chest Wall Compression Compared to Airway Clearance Techniques in Non-Hospitalized Infants With Acute Viral Bronchiolitis.,"BACKGROUND
No studies have investigated the use and safety of high-frequency chest wall compression (HFCWC) for non-hospitalized infants with acute viral bronchiolitis (AVB). The aim of the present study was to evaluate the immediate effects and safety of HFCWC as compared to airway clearance techniques in children with AVB.
METHODS
In this randomized clinical trial in non-hospitalized infants (0-12 months old) with mild to moderate AVB, children were randomized into 2 groups: airway clearance techniques (20 min of prolonged slow expiration and provoked cough) or HFCWC (15 min). A single session was performed and children were evaluated at baseline and at 10 min and 20 min after treatments. Outcomes measures were the Wang severity score, S pO 2 , sputum wet-weight, and the presence of adverse events.
RESULTS
A total of 91 infant subjects, mean age 7.9 ± 2.6 months, were included. Significant ( P = .004) between-group differences were found in the Wang score, which was 0.28 points lower in the airway clearance techniques group. There was a greater increase of infants classified as normal and a greater decrease of those classified as mild according to the Wang score when airway clearance techniques were used compared to the use of HFCWC ( P = .009). The sputum wet-weight was lower in subjects treated with the airway clearance techniques ( P < .001). Although S pO 2 improved in both groups, no differences were found between them. There was also no difference for adverse events, and the majority of children did not present any adverse events after 20 min.
CONCLUSIONS
The use of HFCWC induced similar clinical effects as airway clearance techniques and was safe for non-hospitalized infants with AVB. Both techniques reduced respiratory symptoms and acutely improved S pO 2 . (ClinicalTrials.gov: NCT03835936.).",2020,"There was also no difference for adverse events, and the majority of children did not present any adverse events after 20 min.
","['non-hospitalized infants with AVB', 'children with AVB', 'Non-Hospitalized Infants With Acute Viral Bronchiolitis', 'non-hospitalized infants with acute viral bronchiolitis (AVB', 'A total of 91 infant subjects, mean age 7.9 ± 2.6 months, were included', 'non-hospitalized infants (0-12 months old) with mild to moderate AVB, children']","['airway clearance techniques (20 min of prolonged slow expiration and provoked cough) or HFCWC', 'HFCWC', 'High-Frequency Chest Wall Compression Compared to Airway Clearance Techniques', 'high-frequency chest wall compression (HFCWC']","['respiratory symptoms', 'adverse events', 'sputum wet-weight', 'Wang severity score, S pO 2 , sputum wet-weight, and the presence of adverse events']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0339941', 'cui_str': 'Acute viral bronchiolitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1136075', 'cui_str': 'High-Frequency Chest Compression'}]","[{'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",91.0,0.0553285,"There was also no difference for adverse events, and the majority of children did not present any adverse events after 20 min.
","[{'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'González-Bellido', 'Affiliation': 'Fisiobronquial Physiotherapy Clinic, Coslada, Madrid, Spain.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Velaz-Baza', 'Affiliation': 'Fisiobronquial Physiotherapy Clinic, Coslada, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Blanco-Moncada', 'Affiliation': 'Fisiobronquial Physiotherapy Clinic, Coslada, Madrid, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Del Carmen Jimeno Esteo', 'Affiliation': 'Fisiobronquial Physiotherapy Clinic, Coruña, Galicia, Spain.'}, {'ForeName': 'Juan Nicolás', 'Initials': 'JN', 'LastName': 'Cuenca-Zaldívar', 'Affiliation': 'Rehabilitation Service, Guadarrama Hospital, Guadarrama, Spain. j.cuenca.prof@ufv.es.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Colombo-Marro', 'Affiliation': 'Pediatric Service, Babynat Clinic, Madrid, Spain.'}, {'ForeName': 'Márcio Vinícius Fagundes', 'Initials': 'MVF', 'LastName': 'Donadio', 'Affiliation': 'Laboratory of Pediatric Physical Activity, Infant Center, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Torres-Castro', 'Affiliation': 'Department of Physical Therapy, Faculty of Medicine, University of Chile, Santiago, Chile.'}]",Respiratory care,['10.4187/respcare.08177']
1829,33144464,"New Anastomosis Technique to Prevent Anastomotic Leakage in Laparoscopic Anterior Resection for Rectal Cancer, Especially Upper Rectal Cancer.","BACKGROUND/AIM
Anastomotic leakage (AL) is a major problem in rectal cancer surgery. To prevent AL, we developed a side-to-side anastomosis technique using a circular stapler and termed it the circular side stapling technique (CST). We herein report the method and outcome of the CST.
PATIENTS AND METHODS
In this study, we analyzed 154 patients with stage 0 to III rectal cancer who underwent curative laparoscopic low anterior resection. Perioperative factors and complications were compared between the CST and usual double stapling technique (DST).
RESULTS
The CST was performed in 110 of the 154 patients. When comparing the outcomes of patients with upper rectal cancer. AL occurred in no patients in the CST group and in three patients in the DST group (p=0.011). The CST prevented AL in all patients with upper rectal cancer.
CONCLUSION
The CST is a safe and useful procedure in laparoscopic anterior resection. This technique can prevent AL, especially in patients with upper rectal cancer.",2020,AL occurred in no patients in the CST group and in three patients in the DST group (p=0.011).,"['patients with upper rectal cancer', 'rectal cancer surgery', '110 of the 154 patients', '154 patients with stage 0 to III rectal cancer who underwent']","['DST', 'Laparoscopic Anterior Resection', 'circular stapler and termed it the circular side stapling technique (CST', 'CST and usual double stapling technique (DST', 'CST', 'New Anastomosis Technique', 'curative laparoscopic low anterior resection']","['AL', 'Perioperative factors and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0441763', 'cui_str': 'Stage 0'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0185012', 'cui_str': 'Closure by staple'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1282913', 'cui_str': 'Circular'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior'}]","[{'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",154.0,0.0387577,AL occurred in no patients in the CST group and in three patients in the DST group (p=0.011).,"[{'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Naotaka', 'Initials': 'N', 'LastName': 'Kuriyama', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Jogo', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Hokonohara', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Qingjiang', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Hisamatsu', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Nakanishi', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Nakashima', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Yasue', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Oki', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan okieiji@surg2.med.kyushu-u.ac.jp.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}]","In vivo (Athens, Greece)",['10.21873/invivo.12195']
1830,33144468,Oncological Outcomes of Pathological T1 Lower Rectal Cancer Patients With or Without Preoperative Chemoradiotherapy.,"BACKGROUND/AIM
It remains unclear whether rectal cancers down-staged by preoperative chemoradiotherapy (CRT) have similar prognoses to those of the same stage without preoperative CRT. We compared prognoses of pT1 rectal cancer patients stratified by preoperative CRT.
PATIENTS AND METHODS
We retrieved data of patients with pathological T1 rectal cancer between 2003 and 2020. Patients were divided into the ""ypT1 group"" who received preoperative CRT following surgery and the ""pT1 group"" who underwent surgery alone. Factors associated with relapse-free survival (RFS) were investigated.
RESULTS
Among 86 patients, ypT1 and pT1 groups comprised 18 and 68 patients, respectively. There was no significant difference in RFS between the groups (p=0.19). Tumor location within 5 cm from the anal verge was associated with recurrence (hazard ratio: 0.13, p=0.034).
CONCLUSION
The prognosis of patients with ypT1 rectal cancer was similar to that of patients with pT1. Low tumor location was a poor prognostic factor.",2020,"Tumor location within 5 cm from the anal verge was associated with recurrence (hazard ratio: 0.13, p=0.034).
","['pT1 rectal cancer patients stratified by preoperative CRT', 'Pathological T1 Lower Rectal Cancer Patients With or Without Preoperative Chemoradiotherapy', 'patients with pathological T1 rectal cancer between 2003 and 2020', 'patients with ypT1 rectal cancer', '86 patients, ypT1 and pT1 groups comprised 18 and 68 patients, respectively']","['ypT1 group"" who received preoperative CRT following surgery and the ""pT1 group"" who underwent surgery alone', 'preoperative chemoradiotherapy (CRT']","['relapse-free survival (RFS', 'RFS']","[{'cui': 'C0332391', 'cui_str': 'pT1 category'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332391', 'cui_str': 'pT1 category'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0481917,"Tumor location within 5 cm from the anal verge was associated with recurrence (hazard ratio: 0.13, p=0.034).
","[{'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Taira', 'Affiliation': 'Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan ttaira.tky@gmail.com.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Nozawa', 'Affiliation': 'Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Kawai', 'Affiliation': 'Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kazuhito', 'Initials': 'K', 'LastName': 'Sasaki', 'Affiliation': 'Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Murono', 'Affiliation': 'Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kaneko', 'Affiliation': 'Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Shigenobu', 'Initials': 'S', 'LastName': 'Emoto', 'Affiliation': 'Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yuuki', 'Initials': 'Y', 'LastName': 'Iida', 'Affiliation': 'Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Ishii', 'Affiliation': 'Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Anzai', 'Affiliation': 'Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Sonoda', 'Affiliation': 'Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Ishihara', 'Affiliation': 'Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan.'}]","In vivo (Athens, Greece)",['10.21873/invivo.12199']
1831,33144772,A comparative evaluation of propolis and light-cured ormocer-based desensitizer in reducing dentin hypersensitivity.,"Objectives
The purpose of the study was to evaluate and compare the clinical efficacy and the durability of propolis and Light-cured ormocer-based desensitizer (Admira Protect, Voco: Cuxhaven Germany) in the treatment of dentin hypersensitivity (DH).
Materials and Methods
The study was conducted over a period of 2 months on 13 patients with 72 hypersensitive teeth, randomly allocated into three treatment groups: Group A: Treated with Propolis, Group B: Admira protect (Voco: Cuxhaven Germany), and Group C: Sterile water (Placebo control). Baseline sensitivity was recorded by the operator using tactile and evaporative stimuli. Visual analog scale (VAS) was used to record the degree of sensitivity perceived by the patients. All the groups received applications of allotted materials on day 1, 7, 14, and 21. After each applications VAS scoring was recorded. On day 30 and 60, only pain evaluation was done to determine the durability of each test materials.
Statistical Analysis
One-way ANOVA, repeated measure ANOVA and post hoc test was done for multiple comparison.
Results
All the groups showed significant results in reducing DH. Among Groups A and B, Group B showed immediate postoperative result at the end of the 1 st week.
Conclusion
Both the test materials were effective in reducing DH but Admira protect was found to be more efficient in reducing pain with longer duration of action (CTRI regd no: CTRI/2017/12/010755).",2020,"Conclusion
Both the test materials were effective in reducing DH but Admira protect was found to be more efficient in reducing pain with longer duration of action (CTRI regd no: CTRI/2017/12/010755).","['13 patients with 72 hypersensitive teeth', 'dentin hypersensitivity (DH']","['propolis and light-cured ormocer-based desensitizer', 'Propolis, Group B', 'propolis and Light-cured ormocer-based desensitizer (Admira Protect, Voco: Cuxhaven Germany']","['dentin hypersensitivity', 'clinical efficacy', 'Baseline sensitivity', 'Visual analog scale (VAS', 'immediate postoperative result', 'reducing DH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C1259642', 'cui_str': 'Ormocer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C2606364', 'cui_str': 'admira protect'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",13.0,0.0124472,"Conclusion
Both the test materials were effective in reducing DH but Admira protect was found to be more efficient in reducing pain with longer duration of action (CTRI regd no: CTRI/2017/12/010755).","[{'ForeName': 'Snigdha', 'Initials': 'S', 'LastName': 'Maity', 'Affiliation': 'Department of Periodontology, JSS Dental College and Hospital, Mysuru, Karnataka, India.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Priyadharshini', 'Affiliation': 'Department of Periodontology, JSS Dental College and Hospital, Mysuru, Karnataka, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Basavaraju', 'Affiliation': 'Department of Periodontology, JSS Dental College and Hospital, Mysuru, Karnataka, India.'}]",Journal of Indian Society of Periodontology,['10.4103/jisp.jisp_500_19']
1832,33144774,"Lateral osteoperiosteal flap versus lateral pedicle flap in the treatment of class III gingival recession: A single-center, open-label trial.","Aims
The aim of this study was to compare outcomes of lateral osteoperiosteal flap (OPF) and lateral pedicle flap (LPF) in the treatment of Miller's Class III gingival recession.
Materials and Methods
Twenty-two anterior maxillary and mandibular sites from 16 participants requiring mucogingival surgery for Miller's Class III gingival recession were included in the study. Eleven sites each were assigned to two groups. OPF: sites treated with lateral OPF and LPF: sites treated with LPF. Recession depth (RD) and bone level (BL) were the primary outcome variables, and probing pocket depth, clinical attachment level (CAL), and keratinized tissue width (KTW) were the secondary variables. All the variables were recorded at baseline (on the day of surgery), 3 months, and 6 months postsurgery.
Results
OPF and LPF resulted in similar reduction in RD at the end of the study period ( P ≤ 0.001). There was no statistically significant difference in RD between OPF and LPF at 6 months ( P = 0.862). OPF-treated sites showed greater gain in BL at 3 months ( P = 0.0004) and 6 months ( P = 0.0002). No significant differences were seen between OPF and LPF in measures of PD, CAL, and KTW.
Conclusion
Data from this 6-month trial seem to suggest that OPF can be used as an alternative procedure for treating Miller's class III recessions with adjacent edentulous sites or wide interproximal spaces. Long-term effects of OPF on the stability of root coverage outcomes are an exciting direction for future research.",2020,There was no statistically significant difference in RD between OPF and LPF at 6 months (,"['class III gingival recession', ""Miller's Class III gingival recession"", ""16 participants requiring mucogingival surgery for Miller's Class III gingival recession were included in the study""]","['LPF', 'lateral osteoperiosteal flap (OPF) and lateral pedicle flap (LPF', 'OPF', 'lateral OPF and LPF', 'Lateral osteoperiosteal flap versus lateral pedicle flap']","['OPF and LPF in measures of PD, CAL, and KTW', 'Recession depth (RD) and bone level (BL', 'gain in BL', 'probing pocket depth, clinical attachment level (CAL), and keratinized tissue width (KTW', 'RD']","[{'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0450136', 'cui_str': 'Pedicle flap'}, {'cui': 'C0038925', 'cui_str': 'Flap'}]","[{'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0450136', 'cui_str': 'Pedicle flap'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0182400', 'cui_str': 'Probe'}]",22.0,0.0315115,There was no statistically significant difference in RD between OPF and LPF at 6 months (,"[{'ForeName': 'Yarabham', 'Initials': 'Y', 'LastName': 'Chakravarthy', 'Affiliation': 'Department of Periodontics, SVS Institute of Dental Sciences, Mahbubnagar, Telangana, India.'}, {'ForeName': 'Rampalli Viswa', 'Initials': 'RV', 'LastName': 'Chandra', 'Affiliation': 'Department of Periodontics, SVS Institute of Dental Sciences, Mahbubnagar, Telangana, India.'}, {'ForeName': 'Aileni Amarender', 'Initials': 'AA', 'LastName': 'Reddy', 'Affiliation': 'Department of Periodontics, SVS Institute of Dental Sciences, Mahbubnagar, Telangana, India.'}, {'ForeName': 'Gollapalle Prabhandh', 'Initials': 'GP', 'LastName': 'Reddy', 'Affiliation': 'Department of Periodontics, SVS Institute of Dental Sciences, Mahbubnagar, Telangana, India.'}]",Journal of Indian Society of Periodontology,['10.4103/jisp.jisp_489_19']
1833,33144869,"Efficacy and Safety of Chinese Herbal Formula Granules in Treating Chronic Kidney Disease Stage 3: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Clinical Trial.","Background
It is generally considered that traditional Chinese medicine (TCM) therapy postpones the progression of some chronic kidney diseases (CKDs). Chinese medicine herbs are widely applied in TCM therapy. We aimed to evaluate clinical efficacy and safety of Chinese herbal formula granules in patients with CKD stage 3 through a prospective randomized controlled study.
Methods
A total of 343 participants with CKD stage 3 were recruited from 9 hospitals in Jiangsu Province between April 2014 and October 2016. Participants were randomly assigned to a treatment or control group. Patients in the treatment group orally took Chinese herbal formula granules twice a day, while controls received placebo granules. The duration of intervention was 24 weeks. Primary outcomes were 24-hour proteinuria, serum creatinine, and eGFR, which were measured every 4 weeks.
Results
There was no statistical difference in 24-hour proteinuria between the two groups (0.97 ± 1.14 g/d vs. 0.97 ± 1.25 g/d). Patients in the treatment group had significantly lower serum creatinine level (130.78 ± 32.55 μ mol/L versus 149.12 ± 41.27 μ mol/L) and significantly higher eGFR level (55.74 ± 50.82 ml/min/1.73·m 2 versus 44.46 ± 12.60 ml/min/1.73·m 2 ) than those in the control group ( P < 0.05). There was no significant difference between two groups in the incidence of adverse events.
Conclusion
The treatment adopting Chinese herbal formula granules for 24 weeks improved kidney function of patients with CKD stage 3.",2020,Patients in the treatment group had significantly lower serum creatinine level (130.78 ± 32.55 μ mol/L versus 149.12 ± 41.27 μ mol/L) and significantly higher eGFR level (55.74 ± 50.82 ml/min/1.73·m 2 versus 44.46 ± 12.60 ml/min/1.73·m 2 ) than those in the control group ( P < 0.05).,"['patients with CKD stage 3', '343 participants with CKD stage 3 were recruited from 9 hospitals in Jiangsu Province between April 2014 and October 2016']","['Chinese herbal formula granules', 'Chinese Herbal Formula Granules', 'traditional Chinese medicine (TCM) therapy', 'Placebo', 'placebo granules']","['serum creatinine level', 'Efficacy and Safety', 'eGFR level', '24-hour proteinuria, serum creatinine, and eGFR', '24-hour proteinuria', 'clinical efficacy and safety', 'incidence of adverse events', 'kidney function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",343.0,0.184757,Patients in the treatment group had significantly lower serum creatinine level (130.78 ± 32.55 μ mol/L versus 149.12 ± 41.27 μ mol/L) and significantly higher eGFR level (55.74 ± 50.82 ml/min/1.73·m 2 versus 44.46 ± 12.60 ml/min/1.73·m 2 ) than those in the control group ( P < 0.05).,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Nephrology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Nephrology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Zhuxing', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ""Department of Nephrology, Wuxi People's Hospital, Wuxi, Jiangsu, China.""}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Changzhou TCM Hospital, Changzhou, Jiangsu, China.'}, {'ForeName': 'Chunhua', 'Initials': 'C', 'LastName': 'Cao', 'Affiliation': 'Department of Nephrology, Taizhou Hospital of TCM, Taizhou, Zhejiang, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ""Department of Nephrology, The First People's Hospital of Changzhou, Changzhou, Jiangsu, China.""}, {'ForeName': 'Jipei', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Nephrology, Wuxi Hospital of TCM, Wuxi, Jiangsu, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Nephrology, Xuzhou No.1 People's Hospital, Xuzhou, Jiangsu, China.""}, {'ForeName': 'Changying', 'Initials': 'C', 'LastName': 'Xing', 'Affiliation': 'Department of Nephrology, Jiangsu Province Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Jiangsu Province Official Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Meixiao', 'Initials': 'M', 'LastName': 'Sheng', 'Affiliation': 'Department of Nephrology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Enchao', 'Initials': 'E', 'LastName': 'Zhou', 'Affiliation': 'Department of Nephrology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lingdong', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Nephrology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Gao', 'Affiliation': 'Department of Nephrology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Yi', 'Affiliation': 'Department of Nephrology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Department of Nephrology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Nephrology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/4073901']
1834,33144870,Efficacy of Acupuncture and Moxibustion as a Subsequent Treatment after Second-Line Chemotherapy in Advanced Gastric Cancer.,"Objective
To explore whether acupuncture and moxibustion can prevent disease progression of advanced gastric cancer patients completing second-line chemotherapy and, if so, the related mechanism.
Method
Progression-free survival (PFS) and overall survival (OS) were main outcome measures. The real-time quantitative PCR was used to detect the expression of genes including T-bet, IFN- γ , GATA3, and IL-4 in peripheral blood mononuclear cells (PBMCs). IL-4, IL-6, Ca199, CRP, and IFN- γ in plasma levels were checked.
Results
170 patients were randomly assigned in a 3 : 2 ratio to receive either acupuncture and moxibustion or sham acupuncture until progression. 135 patients were included in the primary analysis. Both PFS and OS in treatment group were proven to be better than control group. Acupuncture and moxibustion promoted typical Th1 cells drifting, as confirmed by increased T-bet/IFN- γ and decreased GATA3/IL-4 in mRNA levels from PBMCs, as well as upregulating IFN- γ and downregulating IL-4 in plasma levels. IL-6, Ca199, and CRP in plasma levels were also reduced by acupuncture and moxibustion.
Conclusions
Acupuncture and moxibustion can prolong PFS and OS of advanced gastric cancer patients completing second-line chemotherapy by reversing Th1/Th2 shift and attenuating inflammatory responses.",2020,"Acupuncture and moxibustion promoted typical Th1 cells drifting, as confirmed by increased T-bet/IFN- γ and decreased GATA3/IL-4 in mRNA levels from PBMCs, as well as upregulating IFN- γ and downregulating IL-4 in plasma levels.","['170 patients', 'advanced gastric cancer patients completing second', 'Advanced Gastric Cancer', 'advanced gastric cancer patients', '135 patients were included in the primary analysis']","['line chemotherapy', 'Acupuncture and moxibustion', 'acupuncture and moxibustion or sham acupuncture until progression', 'acupuncture and moxibustion', 'Acupuncture and Moxibustion']","['Method\n\n\nProgression-free survival (PFS) and overall survival (OS', ' IL-4, IL-6, Ca199, CRP, and IFN- γ in plasma levels', 'expression of genes including T-bet, IFN- γ , GATA3, and IL-4 in peripheral blood mononuclear cells (PBMCs', 'IL-6, Ca199, and CRP in plasma levels']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C1307598', 'cui_str': 'GATA3 protein, human'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}]",170.0,0.208651,"Acupuncture and moxibustion promoted typical Th1 cells drifting, as confirmed by increased T-bet/IFN- γ and decreased GATA3/IL-4 in mRNA levels from PBMCs, as well as upregulating IFN- γ and downregulating IL-4 in plasma levels.","[{'ForeName': 'Yong-Jie', 'Initials': 'YJ', 'LastName': 'Zhang', 'Affiliation': ""Huai'an Hospital Affiliated to Xuzhou Medical University, Huai'an 223002, Jiangsu, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Min', 'Affiliation': ""Huai'an Hospital Affiliated to Xuzhou Medical University, Huai'an 223002, Jiangsu, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Huai'an Hospital Affiliated to Xuzhou Medical University, Huai'an 223002, Jiangsu, China.""}, {'ForeName': 'Huai-Dong', 'Initials': 'HD', 'LastName': 'Liu', 'Affiliation': ""Huai'an Hospital Affiliated to Xuzhou Medical University, Huai'an 223002, Jiangsu, China.""}, {'ForeName': 'Zi-Yuan', 'Initials': 'ZY', 'LastName': 'Zhu', 'Affiliation': ""Huai'an Hospital Affiliated to Xuzhou Medical University, Huai'an 223002, Jiangsu, China.""}, {'ForeName': 'Fu-Jin', 'Initials': 'FJ', 'LastName': 'Jiang', 'Affiliation': ""Huai'an Hospital Affiliated to Xuzhou Medical University, Huai'an 223002, Jiangsu, China.""}, {'ForeName': 'Hai-Qing', 'Initials': 'HQ', 'LastName': 'Hua', 'Affiliation': 'General Hospital of Eastern Theater Command Affiliated to Nanjing University of Chinese Medicine, Nanjing 210002, Jiangsu, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/8274021']
1835,33145131,Comparison of the Efficacy of Tramadol and Paroxetine in the Management of Premature Ejaculation.,"Objective The goal of this study was to compare the efficacy of tramadol and paroxetine in the treatment of primary premature ejaculation (PE). Study design This study was a randomized controlled trial performed in the outpatient department of Nishtar Hospital, Multan, from January 2017 to January 2018. Methodology One hundred six patients were diagnosed with PE and included in the study. The patients were categorized into two groups receiving either tramadol or paroxetine through a lottery randomization method. The main variables were baseline PE, baseline satisfaction after intercourse, baseline intravaginal ejaculatory latency time (IELT), ejaculation control, difficulty in ejaculation, and after-treatment satisfaction with sexual intercourse and IELT. We used IBM SPSS Statistics for Windows, Version 23.0 (Armonk, NY: IBM Corp.) for data analysis, and p≤0.05 was considered statistically significant. Results Ejaculation control, difficulty in ejaculation, and distress due to ejaculation in patients in the tramadol group was noted as 24.5%, 7.5%, and 7.5%, respectively. Ejaculation control, difficulty in ejaculation, and distress due to ejaculation in the paroxetine group was noted as 49.1%, 17%, and 24.5%, respectively. The differences were statistically significant within the groups at baseline and after treatment of PE (p<0.001). Conclusion Tramadol is an effective and useful drug as compared to paroxetine for the treatment of PE. Tramadol can be used as an alternative to other medications for the treatment of lifelong PE.",2020,The differences were statistically significant within the groups at baseline and after treatment of PE (p<0.001).,"['hundred six patients were diagnosed with PE and included in the study', 'outpatient department of Nishtar Hospital, Multan, from January 2017 to January 2018', 'primary premature ejaculation (PE', 'Premature Ejaculation']","['Tramadol', 'tramadol or paroxetine', 'tramadol', 'tramadol and paroxetine', 'Tramadol and Paroxetine', 'paroxetine']","['Ejaculation control, difficulty in ejaculation, and distress due to ejaculation', 'baseline PE, baseline satisfaction after intercourse, baseline intravaginal ejaculatory latency time (IELT), ejaculation control, difficulty in ejaculation, and after-treatment satisfaction with sexual intercourse and IELT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0070122', 'cui_str': 'Paroxetine'}]","[{'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]",106.0,0.0441834,The differences were statistically significant within the groups at baseline and after treatment of PE (p<0.001).,"[{'ForeName': 'Muhammad Fazal', 'Initials': 'MF', 'LastName': 'Ur Rehman', 'Affiliation': 'Urology, Bakhtawar Amin Medical and Dental College, Multan, PAK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Imran Zaidi', 'Affiliation': 'Urology, Multan Institute of Kidney Diseases, Multan, PAK.'}, {'ForeName': 'Tanveer', 'Initials': 'T', 'LastName': 'Ul Haq', 'Affiliation': 'Urology, Multan Institute of Kidney Diseases, Multan, PAK.'}, {'ForeName': 'Shoaib', 'Initials': 'S', 'LastName': 'Rafique', 'Affiliation': 'Urology, Multan Institute of Kidney Diseases, Multan, PAK.'}, {'ForeName': 'Farman', 'Initials': 'F', 'LastName': 'Ali', 'Affiliation': 'Internal Medicine, District Headquarter Hospital, Khanewal, PAK.'}]",Cureus,['10.7759/cureus.10725']
1836,33145134,The Risk Factors for the Wearing-Off Phenomenon in Parkinson's Disease.,"INTRODUCTION
First-line treatment of Parkinson's disease (PD) includes a dopamine analog, levodopa, administered in combination with carbidopa to increase efficacy. Wearing-off (WO) phenomenon is a frequent complication which is defined as a reoccurrence of motor and non-motor symptoms during levodopa free interval, which has a negative impact on the quality of life of patients. Through this study, we aim to determine risk factors that lead to the manifestation of the WO phenomenon among patients presenting in our out-patient department of a tertiary care hospital in Pakistan.
METHOD
A observational case-control study was conducted from April 2019 to December 2019 in a tertiary care hospital in Pakistan. A total of 101 patients who had PD were included in the study. They were randomized into two groups i.e. patients who had WO phenomenon (59 participants) and patients who did not experience WO (42 participants) phenomena. Patients were evaluated based on a self-administrated questionnaire. A p-value of less than 0.05 was considered significant.
RESULT
WO was significantly higher in those patients who had earlier onset of Parkinson (59 ± 10 vs. 65 ±8; p<0.002) and had the disease for a longer duration (7.9±5.1 vs. 5.6±3.1, p<0.002). Other findings included, there was more risk of WO in patients on anti-parkinsonian treatment for longer duration (7.2±5.1 vs. 3.9±3.5, p<0.010) and on longer duration on levodopa treatment (6.9±4.9 vs. 3.1±2.8, p<0.0001).
CONCLUSION
Our study demonstrated several factors which are responsible for the WO phenomenon. This will aid neurologists to consider these risk factors while prescribing different treatment modalities for the disease to improve efficacy and mitigate WO effect among patients, specifically while advising levodopa.",2020,"WO was significantly higher in those patients who had earlier onset of Parkinson (59 ± 10 vs. 65 ±8; p<0.002) and had the disease for a longer duration (7.9±5.1 vs. 5.6±3.1,","[""Parkinson's disease (PD"", 'A observational case-control study was conducted from April 2019 to December 2019 in a tertiary care hospital in Pakistan', 'patients presenting in our out-patient department of a tertiary care hospital in Pakistan', '101 patients who had PD were included in the study', '59 participants) and patients who did not experience WO (42 participants) phenomena']","['carbidopa', 'dopamine analog, levodopa', 'WO phenomenon']","['risk of WO', 'WO']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0007328', 'cui_str': 'Case Control Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0852903', 'cui_str': 'On - off phenomenon'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}]",101.0,0.031932,"WO was significantly higher in those patients who had earlier onset of Parkinson (59 ± 10 vs. 65 ±8; p<0.002) and had the disease for a longer duration (7.9±5.1 vs. 5.6±3.1,","[{'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Raja', 'Affiliation': 'Internal Medicine, Shaheed Mohtarma Benazir Bhutto Medical University, Larkana, PAK.'}, {'ForeName': 'Sonam', 'Initials': 'S', 'LastName': 'Ramrakhia', 'Affiliation': 'Medicine, Liaquat University of Medical and Health Sciences, Sukkur, PAK.'}, {'ForeName': 'Kapeel', 'Initials': 'K', 'LastName': 'Dev', 'Affiliation': 'Internal Medicine, Ghulam Muhammad Mahar Medical College, Sukkur, PAK.'}, {'ForeName': 'Wajeeha', 'Initials': 'W', 'LastName': 'Shahid', 'Affiliation': 'Internal Medicine, Jinnah Sindh Medical University, Karachi, PAK.'}, {'ForeName': 'Hamza', 'Initials': 'H', 'LastName': 'Sohail', 'Affiliation': 'Neurology, Jinnah Sindh Medical University, Karachi, PAK.'}, {'ForeName': 'Muhammad Khizar', 'Initials': 'MK', 'LastName': 'Memon', 'Affiliation': 'Internal Medicine, Liaquat University of Medical and Health Sciences, Sukkur, PAK.'}, {'ForeName': 'Sidra', 'Initials': 'S', 'LastName': 'Memon', 'Affiliation': 'Internal Medicine, Jinnah Sindh Medical University, Karachi, PAK.'}]",Cureus,['10.7759/cureus.10729']
1837,33145164,Effect of herbal medicine ( Huanglian-jie-du granule) for somatic symptoms and insomnia in patients with Hwa-byung : A randomized controlled trial.,"Background
Huanglian-jie-du (HJD) granule, which is composed of representative ""heat-clearing"" herbs has been used for Hwa-byung . Hwa-byung is a culture-bound syndrome in Korea, characterized by distinct somatic symptoms such as chest congestion and heat sensation resulting from suppressed anger. We investigated the effect of HJD in patients with Hwa-byung .
Methods
Forty-four patients with Hwa-byung were recruited, and HJD or placebo granules were administered orally three times daily for seven days. The two primary outcomes were somatic symptoms, which were measured by Patient Health Questionnaire of physical symptoms (PHQ-15), and insomnia, which was measured by Insomnia Severity Index (ISI) at post-treatment.
Results
Between July 10 and October 31, 2017, 44 patients with Hwa-byung (mean age 36.68 years; and 38 female) were randomly assigned to HJD (n = 22) or placebo (n = 22) group. After administration of HJD or placebo granule for seven days, ISI score was lower in the HJD group compared to placebo group at post-treatment (adjusted mean difference -2.56 [95% CI -4.72 to -0.39], p = 0.0208). Meanwhile, there was no difference in PHQ-15 score between HJD group and placebo group at post-treatment (adjusted mean difference -0.50 [95% CI: -3.02-4.02], p = 0.7812).
Conclusions
Our results suggest that the administration of HJD granule has a potential to improve insomnia in Hwa-byung patients. Effect of HJD granule for general somatic symptoms in Hwa- byung patients is unclear, and further researches are needed.
Trial registration
Clinical Research Information Service, KCT0002379.",2021,"After administration of HJD or placebo granule for seven days, ISI score was lower in the HJD group compared to placebo group at post-treatment (adjusted mean difference -2.56","['Methods\n\n\nForty-four patients with Hwa-byung were recruited, and HJD or', 'Between July 10 and October 31, 2017, 44 patients with Hwa-byung (mean age 36.68 years; and 38 female', 'patients with Hwa-byung ', 'general somatic symptoms in']","['herbal medicine ( Huanglian-jie-du granule', 'HJD or placebo', 'HJD', 'placebo', 'HJD granule', 'placebo granules']","['PHQ-15 score', 'ISI score', 'somatic symptoms, which were measured by Patient Health Questionnaire of physical symptoms (PHQ-15), and insomnia, which was measured by Insomnia Severity Index (ISI']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520690', 'cui_str': 'Hwa-byung'}, {'cui': 'C1530482', 'cui_str': 'huanglian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}]","[{'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C1530482', 'cui_str': 'huanglian'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]",44.0,0.554059,"After administration of HJD or placebo granule for seven days, ISI score was lower in the HJD group compared to placebo group at post-treatment (adjusted mean difference -2.56","[{'ForeName': 'Yujin', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Yunna', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Neuropsychiatry, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Ojin', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Sun-Yong', 'Initials': 'SY', 'LastName': 'Chung', 'Affiliation': 'Department of Neuropsychiatry, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Hun', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Department of Neuropsychiatry, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}]",Integrative medicine research,['10.1016/j.imr.2020.100453']
1838,33145205,The Correlation between Histopathology of Herniated Lumbar Intervertebral Disc and Clinical Findings.,"Objective
Prolapsed lumbar disc is one of the most frequent diseases, which is usually presented by motor and sensory deficits. Consistency of herniated disc may play a significant role in surgical treatment and postoperative improvement. The objective of this study is to assess whether the histopathological degeneration in the sample of lumbar discs operated on is correlated to clinical variables and surgical outcomes.
Materials and Methods
A randomized double-blind prospective study of lumbar disc prolapse cases over a period of 24 months was done. Forty cases were initially included in the study. All the included cases with a scheduled lumbar discectomy in the Department of Neurosurgery, King Fahd University Hospital, Al-Khobar, Saudi Arabia, during this period were examined histologically.
Results
Finally, 21 patients were only considered in this study due to loss of follow-up of the other 19 patients; of these 21 patients, 18 were male and 3 were female. The youngest patient was 32 years old, and the oldest was 72 years old. There is no significant correlation between the major histopathological changes of the prolapsed discs and the clinical findings of low back pain (correlation coefficient = 0.058, P < 0.8), duration of sciatica (correlation coefficient = -0.337, P < 0.1), paresthesia (correlation coefficient = 0.111, P < 0.6), motor weakness (correlation coefficient = 0.274, P < 0.2), and reflex (correlation coefficient = 0.081, P < 0.7). Meanwhile, the correlation coefficient between numbness and histopathological degeneration score (HPDS) is not defined because all reported cases were presented with numbness.
Conclusions
There is no significant correlation between the histopathological changes of the prolapsed discs and some clinical findings. Moreover, the different types of prolapsed discs' histopathological changes have no impact on the outcome of the surgery. We also concluded that the disc material undergoes certain degenerative processes with age.",2020,"There is no significant correlation between the major histopathological changes of the prolapsed discs and the clinical findings of low back pain (correlation coefficient = 0.058, P < 0.8), duration of sciatica (correlation coefficient = -0.337, P < 0.1), paresthesia (correlation coefficient = 0.111, P < 0.6), motor weakness (correlation coefficient = 0.274, P < 0.2), and reflex (correlation coefficient = 0.081, P < 0.7).","['lumbar disc prolapse cases', 'youngest patient was 32 years old, and the oldest was 72 years old', 'All the included cases with a scheduled lumbar discectomy in the Department of Neurosurgery, King Fahd University Hospital, Al-Khobar, Saudi Arabia, during this period were examined histologically', '21 patients were only considered in this study due to loss of follow-up of the other 19 patients; of these 21 patients, 18 were male and 3 were female', 'Forty cases were initially included in the study']",[],"['low back pain', 'paresthesia', 'motor weakness', 'numbness and histopathological degeneration score (HPDS', 'reflex', 'duration of sciatica']","[{'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",[],"[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036396', 'cui_str': 'Sciatica'}]",21.0,0.0450741,"There is no significant correlation between the major histopathological changes of the prolapsed discs and the clinical findings of low back pain (correlation coefficient = 0.058, P < 0.8), duration of sciatica (correlation coefficient = -0.337, P < 0.1), paresthesia (correlation coefficient = 0.111, P < 0.6), motor weakness (correlation coefficient = 0.274, P < 0.2), and reflex (correlation coefficient = 0.081, P < 0.7).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Ammar', 'Affiliation': 'Department of Neurosurgery, King Fahd University Hospital, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alwadei', 'Affiliation': 'Department of Neurosurgery, King Fahd University Hospital, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al Hayek', 'Affiliation': 'Department of Neurosurgery, King Fahd University Hospital, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Faisal M', 'Initials': 'FM', 'LastName': 'Alabbas', 'Affiliation': 'Department of Neurosurgery, King Fahd University Hospital, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Faisal Rashed', 'Initials': 'FR', 'LastName': 'Almatrafi', 'Affiliation': 'Department of Neurosurgery, King Fahd University Hospital, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Elshawarby', 'Affiliation': 'Department of Pathology, King Fahd University Hospital, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}]",Asian journal of neurosurgery,['10.4103/ajns.AJNS_193_20']
1839,32925959,Cumbersome but desirable-Breaking the code of everyday cycling.,"INTRODUCTION
Cycling for transport could integrate physical activity (PA) into daily routines and potentially increase total PA levels. However, for parents with young children, most factors affecting transport mode choice tend to facilitate car use. Greater insight is necessary into reasons for (not) using sustainable transport modes in parents with young children. Therefore, the objective of this study was to explore the experiences, including motives, perceptions, attitudes, and norms, of parents of young children by using an e-bike, a longtail bike, and a traditional bike for everyday travel to the workplace, kindergarten, and the grocery store during the autumn, winter, and spring, in nine months.
METHODS
Semistructured focus group interviews were conducted with 18 parents of young children residing in southern Norway. Parents were recruited through Facebook announcements and direct contact with kindergartens, selected organisations, and companies in the Kristiansand municipality. Data were analysed by systematic text condensation by using NVivo V.11.
RESULTS
Participants' experiences were summarised by three main themes: 'cycling is cumbersome', 'cycling reflects the desirable me', and 'breaking the cycling code'. Time use, planning, logistics, wet and cold weather, long distances, and no cycling habit were frequently mentioned barriers, and the most notable facilitator was the children's attitude towards cycling. In general, children loved to cycle and preferred cycling to driving. Additionally, the freedom and independence of cycling were emphasised and valued.
CONCLUSION
In challenging weather conditions, parents of young children may experience cycling as cumbersome but desirable, and bike access could increase the feasibility of daily cycling.",2020,"RESULTS
Participants' experiences were summarised by three main themes: 'cycling is cumbersome', 'cycling reflects the desirable me', and 'breaking the cycling code'.","['Parents were recruited through Facebook announcements and direct contact with kindergartens, selected organisations, and companies in the Kristiansand municipality', '18 parents of young children residing in southern Norway', 'parents with young children']",[],"['total PA levels', 'Time use, planning, logistics, wet and cold weather, long distances, and no cycling habit']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0242415', 'cui_str': 'Logistics'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0337005', 'cui_str': 'Cold weather'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",,0.0300279,"RESULTS
Participants' experiences were summarised by three main themes: 'cycling is cumbersome', 'cycling reflects the desirable me', and 'breaking the cycling code'.","[{'ForeName': 'Helga Birgit', 'Initials': 'HB', 'LastName': 'Bjørnarå', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Westergren', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Fegran', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Saskia J', 'Initials': 'SJ', 'LastName': 'Te Velde', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Aslak', 'Initials': 'A', 'LastName': 'Fyhri', 'Affiliation': 'Department of Safety and the Environment, Institute of Transport Economics, Oslo, Norway.'}, {'ForeName': 'Benedicte', 'Initials': 'B', 'LastName': 'Deforche', 'Affiliation': 'Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Lars Bo', 'Initials': 'LB', 'LastName': 'Andersen', 'Affiliation': 'Western Norwegian University of Applied Sciences, Faculty of Education, Arts and Sport, Sogndal, Norway.'}, {'ForeName': 'Sveinung', 'Initials': 'S', 'LastName': 'Berntsen', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Elling', 'Initials': 'E', 'LastName': 'Bere', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Agder, Kristiansand, Norway.'}]",PloS one,['10.1371/journal.pone.0239127']
1840,32946459,Assessment of the validity and reliability of the 32-item Motor Function Measure in individuals with Type 2 or non-ambulant Type 3 spinal muscular atrophy.,"The 32-item Motor Function Measure (MFM32) is an assessment of motor function, and its measurement properties were established in a broad neuromuscular disease population. This study sought to investigate the reliability, validity, and ability to detect change of MFM32 in individuals with Type 2 and non-ambulant Type 3 spinal muscular atrophy (SMA). Data were used from the Phase 2 study assessing the efficacy and safety of olesoxime. A total of 110 individuals with Type 2 or 3 SMA were included in the analyses. Test-retest reliability (intraclass-correlation coefficient in global impression-defined stable individuals), internal consistency (Cronbach's alpha), convergent validity (Spearman rank order correlations with other measures), known-groups validity (analysis of covariance comparing Hammersmith Functional Motor Scale -defined groups), and ability to detect change (analysis of covariance comparing global impression-defined groups) were calculated. Strong evidence of test-retest reliability (intraclass-correlation coefficient = 0.93-0.95), internal consistency (Cronbach's alpha = 0.89), convergent validity (Hammersmith Functional Motor Scale: rho = 0.87; forced vital capacity: rho = 0.61), known-groups validity (all p<0.0001), and ability to detect change (all p<0.001) were demonstrated. These results provide evidence of the MFM32's measurement properties, supporting its use in longitudinal research in individuals with Type 2 and non-ambulant Type 3 SMA.",2020,"The 32-item Motor Function Measure (MFM32) is an assessment of motor function, and its measurement properties were established in a broad neuromuscular disease population.","['110 individuals with Type 2 or 3 SMA were included in the analyses', 'individuals with Type 2 and non-ambulant Type 3 spinal muscular atrophy (SMA', 'individuals with Type 2 or non-ambulant Type 3 spinal muscular atrophy', 'individuals with Type 2 and non-ambulant Type 3 SMA']",[],"['convergent validity (Hammersmith Functional Motor Scale', 'efficacy and safety of olesoxime']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0152109', 'cui_str': 'Kugelberg-Welander disease'}]",[],"[{'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0335933', 'cui_str': 'Hammersmith'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2001394', 'cui_str': 'olesoxime'}]",110.0,0.0171854,"The 32-item Motor Function Measure (MFM32) is an assessment of motor function, and its measurement properties were established in a broad neuromuscular disease population.","[{'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Trundell', 'Affiliation': 'Roche Products Limited, Welwyn, United Kingdom.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Le Scouiller', 'Affiliation': 'Roche Products Limited, Welwyn, United Kingdom.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Le Goff', 'Affiliation': 'Department of Pediatric Physical Medicine and Rehabilitation, Hôpital Mère Enfant, CHU-Lyon, Lyon University, Lyon, France.'}, {'ForeName': 'Ksenija', 'Initials': 'K', 'LastName': 'Gorni', 'Affiliation': 'PDMA Neuroscience and Rare Disease, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Vuillerot', 'Affiliation': 'Department of Pediatric Physical Medicine and Rehabilitation, Hôpital Mère Enfant, CHU-Lyon, Lyon University, Lyon, France.'}]",PloS one,['10.1371/journal.pone.0238786']
1841,30772533,Patient-reported triggers of paroxysmal atrial fibrillation.,"BACKGROUND
Triggers for discrete atrial fibrillation (AF) events remain poorly studied and incompletely characterized.
OBJECTIVE
The purpose of this study was to describe common triggers for AF and their relationships with patient characteristics.
METHODS
We invited symptomatic, paroxysmal AF patients enrolled in the Health eHeart Study and through the patient-centered advocacy organization StopAfib.org to complete a questionnaire regarding their AF triggers and cardiovascular risk factors.
RESULTS
Of 1295 participants with symptomatic AF, 957 (74%) reported triggers for episodes of AF. In comparison to participants without triggers and after multivariate adjustment, those reporting triggers had a 71% lower odds of congestive heart failure (odds ratio [OR] 0.29; 95% confidence interval [CI] 0.14-0.60; P = .001) and a >2-fold greater odds of a family history of AF (OR 2.04; 95% CI 1.21-3.47; P = .008). The most commonly reported triggers were alcohol (35%), caffeine (28%), exercise (23%), and lack of sleep (21%). Multivariable models revealed that younger patients, women, and those with an AF family history more commonly experienced various triggers. Patients reported a median of 2 different triggers (interquartile range 1-3). Female sex, Hispanic ethnicity, obstructive sleep apnea, and a family history of AF were each associated with a greater number of AF triggers. Vagally mediated triggers tended to cluster together within individuals.
CONCLUSION
The majority of patient-reported triggers are modifiable, potentially identifying accessible means to prevent and reduce AF episodes. Exploring the interactions between AF patient type, including underlying genetic differences, and common exposures may be fruitful areas of investigation.",2019,"The most commonly reported triggers were alcohol (35%), caffeine (28%), exercise (23%), and lack of sleep (21%).","['paroxysmal AF patients enrolled in the Health eHeart Study and through the patient-centered advocacy organization StopAfib.org to complete a questionnaire regarding their AF triggers and cardiovascular risk factors', '1295 participants with symptomatic AF, 957 (74%) reported']",['caffeine'],"['paroxysmal atrial fibrillation', 'lack of sleep', 'triggers for episodes of AF', 'Female sex, Hispanic ethnicity, obstructive sleep apnea', 'congestive heart failure']","[{'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0150446', 'cui_str': 'Advocacy'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4517556', 'cui_str': '1295'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]",1295.0,0.101963,"The most commonly reported triggers were alcohol (35%), caffeine (28%), exercise (23%), and lack of sleep (21%).","[{'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Groh', 'Affiliation': 'Division of Cardiology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Madelaine', 'Initials': 'M', 'LastName': 'Faulkner', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Shiffen', 'Initials': 'S', 'LastName': 'Getabecha', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Taffe', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Nah', 'Affiliation': 'Division of Cardiology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Kathi', 'Initials': 'K', 'LastName': 'Sigona', 'Affiliation': 'Member of Health eHeart Alliance, atrial fibrillation patient.'}, {'ForeName': 'Debbe', 'Initials': 'D', 'LastName': 'McCall', 'Affiliation': 'Member of Health eHeart Alliance, atrial fibrillation patient.'}, {'ForeName': 'Mellanie True', 'Initials': 'MT', 'LastName': 'Hills', 'Affiliation': 'Chief Executive Officer, StopAfib.org, member of Health eHeart Alliance, atrial fibrillation patient.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Sciarappa', 'Affiliation': 'Member of Health eHeart Alliance, atrial fibrillation patient.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Pletcher', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Olgin', 'Affiliation': 'Division of Cardiology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Marcus', 'Affiliation': 'Division of Cardiology, University of California, San Francisco, San Francisco, California. Electronic address: greg.marcus@ucsf.edu.'}]",Heart rhythm,['10.1016/j.hrthm.2019.01.027']
1842,31188081,Higher vitamin B 6 intake is associated with lower depression and anxiety risk in women but not in men: A large cross-sectional study.,"Objective: The prevalence of depression and anxiety is increasing worldwide. Diet as a modifiable factor for mental health has received great attention. The aim of the present study was to evaluate the association of vitamin B6 intake with depression and anxiety. Methods: This cross-sectional study was performed among 3362 adults in 2011. Anxiety and depression were evaluated using an Iranian validated version of the Hospital Anxiety and Depression Scale (HADS) questionnaire. Dietary intakes were evaluated by a validated 106 item self-administered Willett-format dish-based semi quantitative food-frequency questionnaire (DFQ). Results: The mean intake of vitamin B6 (mg/day) was significantly lower in anxious (1.93 ± 0.74 vs. 2.0 ± 0.74; P = 0.02) and depressed (1.86 ± 0.72 vs. 1.99 ± 0.74; P = 0.001) people than healthy participants. The lower level of vitamin B6 intake (tertile 1), after adjustment for the impacts of various confounding variables, in total population and women was associated with the higher odds of depression (OR = 1.41; 95% CI: 1.19, 2.31; P < 0.001. OR = 1.33; 95% CI: 1.08, 2. 21; P = 0.02, respectively). Also, the lower level of vitamin B6 intake (tertile 1) in total population and women was associated with the higher odds of anxiety (OR = 2.30; 95% CI: 1.31, 4.04; P < 0. 001, OR = 2.30; 95% CI: 1.19, 4.46; P = 0.04). Conclusion: The association of lower intakes vitamin B6 intake with increased risk of depression and anxiety was clearly supported by current study. A reasonable approach to tackle these disorders could be the improvement of nutritional status, accordingly large randomized controlled trials are suggested for providing more evidence.",2020,The mean intake of vitamin B6 (mg/day) was significantly lower in anxious (1.93 ± 0.74 vs. 2.0 ± 0.74; P = 0.02) and depressed (1.86 ± 0.72 vs. 1.99 ± 0.74; P = 0.001) people than healthy participants.,['3362 adults in 2011'],['vitamin B6 intake'],"['mean intake of vitamin B6', 'Hospital Anxiety and Depression Scale (HADS) questionnaire', 'Dietary intakes', 'lower level of vitamin B6 intake', 'Anxiety and depression', 'depression and anxiety risk']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0564418', 'cui_str': 'Vitamin B6 intake'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0564418', 'cui_str': 'Vitamin B6 intake'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",3362.0,0.142082,The mean intake of vitamin B6 (mg/day) was significantly lower in anxious (1.93 ± 0.74 vs. 2.0 ± 0.74; P = 0.02) and depressed (1.86 ± 0.72 vs. 1.99 ± 0.74; P = 0.001) people than healthy participants.,"[{'ForeName': 'Marzi', 'Initials': 'M', 'LastName': 'Kafeshani', 'Affiliation': 'Food Security Research Center and Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Awat', 'Initials': 'A', 'LastName': 'Feizi', 'Affiliation': 'Psychosomatic Research Center, Integrative Functional Gastroenterology Research Center and Department of Biostatistics and Epidemiology, School of Public Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': 'Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ammar Hassanzadeh', 'Initials': 'AH', 'LastName': 'Keshteli', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada and Integrative Functional Gastroenterology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Afshar', 'Affiliation': 'Psychosomatic Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Roohafza', 'Affiliation': 'Cardiac rehabilitation research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Adibi', 'Affiliation': 'Integrative Functional Gastroenterology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition,['10.1024/0300-9831/a000589']
1843,31324842,Genetic Polymorphisms in ADORA2A and CYP1A2 Influence Caffeine's Effect on Postprandial Glycaemia.,"The liver enzyme cytochrome P450 1A2 (CYP1A2) is responsible for 90% of caffeine metabolism, while caffeine exerts many of its effects via antagonist binding to adenosine A2a receptors (ADORA2A). This study aimed to examine whether functional single nucleotide polymorphisms (SNPs) in 1976T > C (ADORA2A; rs5751876) and -163C > A (CYP1A2; rs762551) influence the effect of caffeine on the postprandial glucose (GLU) response to a carbohydrate meal. We report that individuals with the 1976T > C CC, but not CT/TT genotypes display elevated GLU levels after consuming caffeine and carbohydrate (CHO + CAFF) versus carbohydrate only (CHO). The GLU area under the curve (AUC) was also greater during the CHO + CAFF condition compared to the CHO condition in CC, but not the CT/TT genotypes. The -163C > A AC/CC, but not AA, genotypes displayed greater GLU concentrations 60-min post meal during CHO + CAFF versus CHO. Our data suggest that caffeine-induced impairments in postprandial glycaemia are related to 1976T > C and -163C > A SNPs.",2019,"The -163C > A AC/CC, but not AA, genotypes displayed greater GLU concentrations 60-min post meal during CHO + CAFF versus CHO.",[],"['caffeine', 'carbohydrate meal']","['postprandial glycaemia', 'GLU levels', 'GLU concentrations', 'postprandial glucose (GLU) response', 'GLU area under the curve (AUC', 'Postprandial Glycaemia']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0061055', 'cui_str': 'gamma-glutamyl-alpha-aminobutyrate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.0142123,"The -163C > A AC/CC, but not AA, genotypes displayed greater GLU concentrations 60-min post meal during CHO + CAFF versus CHO.","[{'ForeName': 'N F', 'Initials': 'NF', 'LastName': 'Banks', 'Affiliation': 'Applied Neuromuscular Physiology Laboratory, Oklahoma State University, Stillwater, OK, USA.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Tomko', 'Affiliation': 'Applied Neuromuscular Physiology Laboratory, Oklahoma State University, Stillwater, OK, USA.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Colquhoun', 'Affiliation': 'Applied Neuromuscular Physiology Laboratory, Oklahoma State University, Stillwater, OK, USA.'}, {'ForeName': 'T W D', 'Initials': 'TWD', 'LastName': 'Muddle', 'Affiliation': 'Applied Neuromuscular Physiology Laboratory, Oklahoma State University, Stillwater, OK, USA.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Emerson', 'Affiliation': 'Laboratory for Applied Nutrition and Exercise Science, Oklahoma State University, Stillwater, OK, USA.'}, {'ForeName': 'N D M', 'Initials': 'NDM', 'LastName': 'Jenkins', 'Affiliation': 'Applied Neuromuscular Physiology Laboratory, Oklahoma State University, Stillwater, OK, USA. nathaniel.jenkins@okstate.edu.'}]",Scientific reports,['10.1038/s41598-019-46931-0']
1844,31442100,The effect of omega-3 and vitamin E on oxidative stress and inflammation: Systematic review and meta-analysis of randomized controlled trials.,"Background: Several studies have investigated the effect of omega-3 fatty acids and vitamin E on oxidative stress and inflammation, but their findings are inconsistent. The aim of this meta-analysis is to elucidate the overall effects of co-supplementation with omega-3 fatty acids and vitamin E on oxidative stress and inflammation. Methods: We searched titles, abstracts, and keywords of relevant articles indexed in PubMed, ISI, Scopus, and Google Scholar databases up to December 2018 to identify eligible RCT studies. Random effects model was used to estimate the pooled effect of co-supplementation with omega-3 fatty acids and vitamin E on oxidative stress and inflammation. Results: Overall, 7 RCTs with 504 participants were included in this meta-analysis. We found that co-supplementation with omega-3 fatty acids and vitamin E decreased hs-CRP (weighed mean difference (WMD) = -2.15 mg/L; 95% CI: -3.40, -0.91 mg/L; P < 0.001) concentrations and increased total antioxidant capacity (TAC) (WMD = 92.87 mmol/L; 95% CI: 31.97, 153.77 mmol/L; P = 0.03), and nitric oxide levels (NO) (WMD: 6.95 μmol/L; 95% CI: 3.86, 10.04, P < 0.001) compared with control group. Omega-3 fatty acids and vitamin E had no significant effect on malondialdehyde (MDA) (WMD: 1.54 mmol/L; 95% CI: -1.29, 4.36; P = 0.196), and glutathione (GSH) (WMD: 20.87 mmol/L; 95% CI: -20.04, 61.6, P = 0.31) levels. Conclusion: The present meta-analysis found that omega-3 fatty acids and vitamin E co-supplementation significantly decreased hs-CRP and increased NO and TAC, although it had no significant effect on MDA and GSH.",2020,"Omega-3 fatty acids and vitamin E had no significant effect on malondialdehyde (MDA) (WMD: 1.54 mmol/L; 95% CI: -1.29, 4.36; P = 0.196), and glutathione (GSH) (WMD: 20.87 mmol/L; 95% CI: -20.04, 61.6, P = 0.31) levels. ",[],"['Omega-3 fatty acids and vitamin E', 'omega-3 fatty acids and vitamin E', 'omega-3 and vitamin E', 'omega-3 fatty acids and vitamin E co-supplementation']","['malondialdehyde (MDA', 'total antioxidant capacity (TAC', 'nitric oxide levels', 'hs-CRP', 'MDA and GSH', 'oxidative stress and inflammation']",[],"[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",504.0,0.172197,"Omega-3 fatty acids and vitamin E had no significant effect on malondialdehyde (MDA) (WMD: 1.54 mmol/L; 95% CI: -1.29, 4.36; P = 0.196), and glutathione (GSH) (WMD: 20.87 mmol/L; 95% CI: -20.04, 61.6, P = 0.31) levels. ","[{'ForeName': 'Seyedeh Parisa', 'Initials': 'SP', 'LastName': 'Moosavian', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Arab', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Mehrabani', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Moradi', 'Affiliation': 'Halal Research Center of IRI, FDA, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Nasirian', 'Affiliation': 'Epidemiology and Biostatistics Department, Health School; and Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition,['10.1024/0300-9831/a000599']
1845,31784280,High plasma microfibrillar-associated protein 4 is associated with reduced surgical repair in abdominal aortic aneurysms.,"OBJECTIVE
Identifying biomarkers for abdominal aortic aneurysms (AAA) could prove beneficial in prognosis of AAA and thus the selection for treatment. Microfibrillar-associated protein 4 (MFAP4) is an extracellular matrix protein that is highly expressed in aorta. MFAP4 is involved in several tissue remodeling-related diseases. We aimed to investigate the potential role of plasma MFAP4 (pMFAP4) as a biomarker of AAA.
METHODS
Plasma samples and data were obtained for 504 male AAA patients and 188 controls in the Viborg Vascular (VIVA) screening trial. The pMFAP4 levels were measured by Alphalisa. The Mann-Whitney U test assessed differences in pMFAP4 levels between the presence and absence of different exposures of interest. The correlation between pMFAP4 and aorta growth rate were investigated through spearman's correlation analysis. Immunohistochemistry and multiple logistic regression adjusted for potential confounders assessed the association between pMFAP4 and AAA. Multiple linear regression assessed the correlation between pMFAP4 and aorta growth rate. Cox regression and competing risk regression were used to investigate the correlation between AAA patients with upper tertile pMFAP4 and the risk of undergoing later surgical repair.
RESULTS
A significant negative correlation between pMFAP4 and aorta growth rate was observed using spearman's correlation analysis (ρ = -0.14; P = .0074). However, this finding did not reach significance when applying multiple linear regression. A tendency of decreased pMFAP4 was observed in AAA using immunohistochemistry. Competing risk regression adjusted for potential confounders indicated that patients with upper tertile pMFAP4 had a hazard ratio of 0.51 (P = .001) for risk of undergoing later surgical repair.
CONCLUSIONS
High levels of pMFAP4 are associated with a decreased likelihood of receiving surgical repair in AAA. This observation warrants confirmation in an independent cohort.",2020,Microfibrillar-associated protein 4 (MFAP4) is an extracellular matrix protein that is highly expressed in aorta.,"['abdominal aortic aneurysms (AAA', '504 male AAA patients and 188 controls in the Viborg Vascular (VIVA) screening trial']","['MFAP4', 'plasma MFAP4', 'Microfibrillar-associated protein 4 (MFAP4']","['pMFAP4', 'pMFAP4 and aorta growth rate', 'pMFAP4 levels']","[{'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",504.0,0.0471143,Microfibrillar-associated protein 4 (MFAP4) is an extracellular matrix protein that is highly expressed in aorta.,"[{'ForeName': 'Jes Sanddal', 'Initials': 'JS', 'LastName': 'Lindholt', 'Affiliation': 'Cardiovascular Research Unit, Viborg Hospital, Viborg, Denmark.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Madsen', 'Affiliation': 'Cancer and Inflammation Research, Department of Molecular Medicine, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Katrine Lindequist', 'Initials': 'KL', 'LastName': 'Kirketerp-Møller', 'Affiliation': 'Cancer and Inflammation Research, Department of Molecular Medicine, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Schlosser', 'Affiliation': 'Cancer and Inflammation Research, Department of Molecular Medicine, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Katrine Lawaetz', 'Initials': 'KL', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiac, Thoracic, and Vascular Surgery, Odense, Denmark.'}, {'ForeName': 'Carsten Behr', 'Initials': 'CB', 'LastName': 'Andersen', 'Affiliation': 'Cardiovascular Research Unit, Viborg Hospital, Viborg, Denmark.'}, {'ForeName': 'Grith Lykke', 'Initials': 'GL', 'LastName': 'Sorensen', 'Affiliation': 'Centre of Individualized Medicine in Arterial Diseases (CIMA), Department of Cardiothoracic and Vascular Surgery, Odense University Hospital, Odense, Denmark; Vascular Research Unit, Department of Vascular Surgery, Viborg Regional Hospital, Viborg, Denmark. Electronic address: glsorensen@health.sdu.dk.'}]",Journal of vascular surgery,['10.1016/j.jvs.2019.08.253']
1846,32472610,Whole genome copy number analysis in search of new prognostic biomarkers in first line treatment of mantle cell lymphoma. A study by the LYSA group.,"Mantle cell lymphoma (MCL) is a lymphoproliferative disorder characterized by the t(11;14)(q13;q32) CCND1/IGH translocation. This lymphoma is however extremely heterogeneous in terms of molecular alterations. Moreover, the course of the disease can vary greatly between indolent forms with slow progression and aggressive conditions rapidly pejorative. The identification of early markers allowing to predict individual patients outcome has however been unsuccessful so far. The LyMa trial treated homogeneously a cohort of young MCL patients. This appeared as a good opportunity to search for biomarkers of response to therapy. DNA extracted from diagnostic paraffin-embedded lymph node biopsies from 100 patients with newly diagnosed MCL, homogeneously treated in this prospective clinical trial, were investigated for copy number alterations and copy neutral loss of heterozygosity using the Oncoscan SNP-array scanning the whole genome. An independent confirmatory cohort was used to strengthen the possibly relevant anomalies observed. Here we describe the recurrent anomalies identified with this technique. Deletions of 17p(TP53) and 9p(CDKN2A) were more frequent in refractory or early relapsing patients (10%), but had no significant impact in univariate analysis on progression-free (PFS) or overall survival (OS). Regardless of the presence of TP53 or CDKN2A deletions, gains in 7p22 (8,5%) were associated with better PFS in univariate but not in multivariate analysis including MCL International Prognostic Index and treatment. Gains of 11q(CCDN1), suggesting gains of the CCND1/IGH fusion, were associated with worse OS and PFS in univariate and multivariate analyses. This worse prognosis impact was confirmed by FISH in an independent confirmatory cohort. This work, using a whole genome approach, confirms the broad genomic landscape of MCL and shows that gains of the CCND1/IGH fusion can be considered as a new prognostic structural variant. Genomic abnormalities of prognostic impact could be useful to strengthen or de-escalate treatment schedules or choosing targeted therapies or CART-cells.",2020,"Deletions of 17p(TP53) and 9p(CDKN2A) were more frequent in refractory or early relapsing patients (10%), but had no significant impact in univariate analysis on progression-free (PFS) or overall survival (OS).","['100 patients with newly diagnosed MCL', 'young MCL patients', 'mantle cell lymphoma']",['LYSA'],"['progression-free (PFS) or overall survival (OS', 'Gains of 11q(CCDN1']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0334634', 'cui_str': 'Mantle cell lymphoma'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],"[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",100.0,0.0428467,"Deletions of 17p(TP53) and 9p(CDKN2A) were more frequent in refractory or early relapsing patients (10%), but had no significant impact in univariate analysis on progression-free (PFS) or overall survival (OS).","[{'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Le Bris', 'Affiliation': 'Hematology Biology Department, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Magrangeas', 'Affiliation': ""CRCINA, INSERM, CNRS, Université d'Angers, Université de Nantes, Nantes, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Moreau', 'Affiliation': 'Pathology Department Nantes University Hospital, now in Centre Hospitalier Départemental de Vendée, La Roche sur Yon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chiron', 'Affiliation': ""CRCINA, INSERM, CNRS, Université d'Angers, Université de Nantes, Nantes, France.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Guérin-Charbonnel', 'Affiliation': ""CRCINA, INSERM, CNRS, Université d'Angers, Université de Nantes, Nantes, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Theisen', 'Affiliation': 'Hematology Biology Department, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Pichon', 'Affiliation': 'Genetic Department, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Canioni', 'Affiliation': 'Pathology Department, Necker University Hospital, Paris, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burroni', 'Affiliation': 'Pathology Department, Cochin University Hospital, Paris, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Maisonneuve', 'Affiliation': 'Hematology Clinic, Centre Hospitalier Départemental de Vendée, La Roche sur Yon, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Thieblemont', 'Affiliation': 'Clinical Hematology Department, Saint Louis University Hospital, Paris, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Oberic', 'Affiliation': 'Clinical Hematology Department, IUCT Oncopole, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Gyan', 'Affiliation': 'Clinical Hematology Department, Tours University Hospital, Tours, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Pellat-Deceunynck', 'Affiliation': ""CRCINA, INSERM, CNRS, Université d'Angers, Université de Nantes, Nantes, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Clinical Hematology Department, Necker University Hospital, Paris, France.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Delfau-Larue', 'Affiliation': 'Immunology Department, Mondor University Hospital, Creteil, France.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Tessoulin', 'Affiliation': ""CRCINA, INSERM, CNRS, Université d'Angers, Université de Nantes, Nantes, France.""}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Béné', 'Affiliation': 'Hematology Biology Department, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Minvielle', 'Affiliation': ""CRCINA, INSERM, CNRS, Université d'Angers, Université de Nantes, Nantes, France.""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Le Gouill', 'Affiliation': ""CRCINA, INSERM, CNRS, Université d'Angers, Université de Nantes, Nantes, France.""}]",Hematological oncology,['10.1002/hon.2750']
1847,33141603,The effect of ego depletion on challenge and threat evaluations during a potentially stressful public speaking task.,"It has been well established that challenge and threat evaluations affect the performance of potentially stressful tasks. However, the factors that influence these evaluations have rarely been examined. Objective : This study examined the effects of ego depletion on challenge and threat evaluations during a public speaking task. Method : 262 participants (150 males, 112 females; M age = 20.5, SD = 4.3) were randomly assigned to either an ego depletion or control group. Participants then completed self-report measures of trait self-control. The ego depletion group performed a written transcription task requiring self-control, while the control group transcribed the text normally. Before the public speaking task, participant's challenge and threat evaluations and subjective ratings of performance were assessed via self-report items. Results : The results of independent t -tests supported the effectiveness of the self-control manipulation. There were no significant differences between the ego depletion and control groups in terms of challenge and threat evaluations or subjective performance. Additional correlation analyses revealed that trait measures of self-control were significantly and negatively related to challenge and threat evaluations and subjective performance. Conclusion : Findings suggest that ego depletion might not influence appraisals of potentially stressful tasks, and thus add to recent evidence questioning the ego-depletion phenomenon.",2020,There were no significant differences between the ego depletion and control groups in terms of challenge and threat evaluations or subjective performance.,"['262 participants (150 males, 112 females; M age \u2009=\u200920.5, SD\u2009 =\u20094.3']","['ego depletion or control group', 'written transcription task requiring self-control, while the control group transcribed the text normally']","['challenge and threat evaluations or subjective performance', 'challenge and threat evaluations and subjective performance', 'trait measures of self-control']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517759', 'cui_str': '4.3'}]","[{'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",262.0,0.0150639,There were no significant differences between the ego depletion and control groups in terms of challenge and threat evaluations or subjective performance.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': ""O'Brien"", 'Affiliation': 'Faculty of Applied Sciences, School of Sport and Exercise, University of Gloucestershire, Gloucester, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fryer', 'Affiliation': 'Faculty of Applied Sciences, School of Sport and Exercise, University of Gloucestershire, Gloucester, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Higher Education Sport, Hartpury University, Gloucester, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Moore', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1839732']
1848,33141616,Metabolomic Effects of Hormone Therapy and Associations with Coronary Heart Disease among Postmenopausal Women.,"Background - In the Women's Health Initiative hormone therapy (WHI-HT) trials, treatment with oral conjugated equine estrogens and medroxyprogesterone acetate (CEE+MPA) resulted in increased risk of coronary heart disease (CHD), while oral conjugated equine estrogens alone (CEE) did not. Methods - 481 metabolites were measured at baseline and at 1-year in 503 and 431 participants in the WHI CEE and CEE+MPA trials, respectively. The effects of randomized HT on the change in metabolite profiles at 1-year was evaluated in linear models adjusting for age, BMI, race, incident CHD, prevalent hypertension and diabetes. Metabolites with discordant effects by HT type were evaluated for association with incident CHD in 944 participants (472 CHD cases) in the WHI Observational Study (WHI-OS), with replication in an independent cohort of 980 men and women at high risk for cardiovascular disease. Results - HT effects on the metabolome were profound; 62% of metabolites significantly changed with randomized CEE and 52% with CEE+MPA (FDR adjusted p value < 0.05) in multivariable models. Concerted increases in abundance were seen within various metabolite classes including triacylglycerols (TAG), phosphatidylethanolamines and phosphatidylcholines (PC); decreases in abundance was observed for acylcarnitines, lysophosphatidylcholines, quaternary amines and cholesteryl/cholesteryl esters. Twelve metabolites had discordant effects by HT type and were associated with incident CHD in the WHI-OS; a metabolite score estimated in a LASSO regression was associated with CHD risk with an odds ratio of 1.47 per SD increase (95% CI: 1.27-1.70, p<10 -6 ). The findings of a subset of four metabolites including C58:11 TAG, C54:9 TAG, C36:1 PC and sucrose replicated in an independent dataset of 980 participants. Conclusions - Randomized treatment with oral HT resulted in large metabolome shifts. Discordant metabolite effects between HT regimens may partially mediate the differences in CHD risk between the two WHI-HT trials.",2020,"Concerted increases in abundance were seen within various metabolite classes including triacylglycerols (TAG), phosphatidylethanolamines and phosphatidylcholines (PC); decreases in abundance was observed for acylcarnitines, lysophosphatidylcholines, quaternary amines and cholesteryl/cholesteryl esters.","['Postmenopausal Women', '944 participants (472 CHD cases) in the WHI Observational Study (WHI-OS), with replication in an independent cohort of 980 men and women at high risk for cardiovascular disease']","['oral HT', 'randomized HT', 'CEE+MPA', 'Hormone Therapy', 'oral conjugated equine estrogens and medroxyprogesterone acetate (CEE+MPA']","['triacylglycerols (TAG), phosphatidylethanolamines and phosphatidylcholines (PC); decreases in abundance', 'risk of coronary heart disease (CHD', 'CHD risk', 'acylcarnitines, lysophosphatidylcholines, quaternary amines and cholesteryl/cholesteryl esters']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0598312', 'cui_str': 'DNA replication'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0031618', 'cui_str': 'Phosphatidylethanolamines'}, {'cui': 'C1959616', 'cui_str': 'Lecithin'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1282512', 'cui_str': 'At risk of coronary heart disease'}, {'cui': 'C0368608', 'cui_str': 'Acylcarnitine'}, {'cui': 'C0024360', 'cui_str': 'Lysolecithin'}, {'cui': 'C0002508', 'cui_str': 'Amine'}, {'cui': 'C0008387', 'cui_str': 'Cholesterol ester'}]",980.0,0.171214,"Concerted increases in abundance were seen within various metabolite classes including triacylglycerols (TAG), phosphatidylethanolamines and phosphatidylcholines (PC); decreases in abundance was observed for acylcarnitines, lysophosphatidylcholines, quaternary amines and cholesteryl/cholesteryl esters.","[{'ForeName': 'Raji', 'Initials': 'R', 'LastName': 'Balasubramanian', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Massachusetts - Amherst, Amherst, MA.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Demler', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Guasch-Ferré', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Nina P', 'Initials': 'NP', 'LastName': 'Paynter', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Sheehan', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Massachusetts - Amherst, Amherst, MA.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA & Departments of Epidemiology and Medicine, Brown University, Providence, RI.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School & Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': ""Universitat Rovira i Virgili, Departament de Bioquímica i Biotecnologia, Unitat de Nutrició Humana, Hospital Universitari San Joan de Reus & Institut d'Investigació Pere Virgili (IISPV), Reus & Consorcio CIBER, M.P. Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.""}, {'ForeName': 'Miguel Á', 'Initials': 'MÁ', 'LastName': 'Martínez-González', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA & Consorcio CIBER, M.P. Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid & Department of Preventive Medicine and Public Health, University of Navarra, Pamplona & IdiSNA (Instituto de Investigación Sanitaria de Navarra), Pamplona, Spain.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Department of Nutrition & Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Clary', 'Initials': 'C', 'LastName': 'Clish', 'Affiliation': 'Broad Institute of the Massachusetts Institute of Technology & Harvard University, Cambridge, MA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rexrode', 'Affiliation': ""Division of Women's Health, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}]",Circulation. Genomic and precision medicine,['10.1161/CIRCGEN.119.002977']
1849,33141635,Cost-Effectiveness of Passion Fruit Albedo versus Turmeric in the Glycemic and Lipaemic Control of People with Type 2 Diabetes: Randomized Clinical Trial.,"BACKGROUND
Robust evidence has related yellow passion fruit albedo and long turmeric to the metabolic and glycemic control of diabetes.
AIM
To analyze the incremental cost-effectiveness of the flour made from yellow passion fruit albedo versus long turmeric merged with piperine in the glycemic and lipid control of individuals with type 2 diabetes.
METHOD
Eighty-nine patients were enrolled in this randomized, placebo-controlled, clinical trial for 120 days. The first group was prescribed 500 mg capsules, three times a day, of yellow passion fruit albedo flour (FAMA). The second group was prescribed long turmeric capsules (500 mg), merged with piperine (5 mg) (CURPI), at fasting. The third group followed the standard advice recommendations, and ingested a placebo of carboxymethyl cellulose (500 mg) at fasting.
RESULTS
The group using FAMA showed a higher reduction (-5.9%) of glycemia after fasting, compared to placebo (+9%), and CURPI (-3.2%) (p < 0.05). Regarding HbA1c, the study observed a significant and similar statistical reduction (-0.8%) in the intervention groups, in contrast with the placebo group (p < 0.05). The reduction in HOMA-IR in the CURPI group (-9.4%) was higher than the other groups (p < 0.05). The CURPI group also showed a higher reduction of serum triglyceride levels (-20.8%) compared to the placebo (-0.09%) and FAMA (+1.8%) (p < 0.05) groups.
CONCLUSION
It was concluded that turmeric is the most cost-effective in comparison with yellow passion fruit albedo, because of its decrease in the levels of triglycerides and HOMA-IR, even when adjusted for confounding variables. On the other hand, HbA1c cost-effectiveness relation was similar.",2020,"The CURPI group also showed a higher reduction of serum triglyceride levels (-20.8%) compared to the placebo (-0.09%) and FAMA (+1.8%) (p < 0.05) groups.
","['People with Type 2 Diabetes', 'Eighty-nine patients', 'individuals with type 2 diabetes']","['yellow passion fruit albedo flour (FAMA', 'Passion Fruit Albedo versus Turmeric', 'standard advice recommendations, and ingested a placebo of carboxymethyl cellulose', 'FAMA', 'placebo', 'flour made from yellow passion fruit albedo versus long turmeric merged with piperine']","['serum triglyceride levels', 'HOMA-IR', 'levels of triglycerides and HOMA-IR', 'FAMA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0221205', 'cui_str': 'Yellow color'}, {'cui': 'C0453287', 'cui_str': 'Passion fruit'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0041356', 'cui_str': 'Turmeric'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007068', 'cui_str': 'Carboxymethylcellulose'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0071112', 'cui_str': 'piperine'}]","[{'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",89.0,0.0423819,"The CURPI group also showed a higher reduction of serum triglyceride levels (-20.8%) compared to the placebo (-0.09%) and FAMA (+1.8%) (p < 0.05) groups.
","[{'ForeName': 'Danilo Ferreira de', 'Initials': 'DF', 'LastName': 'Sousa', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro Brazilian Lusophony University, Redenção, Brazil.'}, {'ForeName': 'Márcio Flávio Moura de', 'Initials': 'MFM', 'LastName': 'Araújo', 'Affiliation': 'Health Family Department, Oswaldo Cruz Foundation, Eusébio, Brazil.'}, {'ForeName': 'Vanessa Derenji', 'Initials': 'VD', 'LastName': 'de Mello', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Marta Maria Coelho', 'Initials': 'MMC', 'LastName': 'Damasceno', 'Affiliation': 'Nursing Department, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Roberto Wagner Júnior Freire de', 'Initials': 'RWJF', 'LastName': 'Freitas', 'Affiliation': 'Health Family Department, Oswaldo Cruz Foundation, Eusébio, Brazil.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2020.1823909']
1850,33141657,Annual mammographic screening to reduce breast cancer mortality in women from age 40 years: long-term follow-up of the UK Age RCT.,"BACKGROUND
There remains disagreement on the long-term effect of mammographic screening in women aged 40-49 years.
OBJECTIVES
The long-term follow-up of a randomised controlled trial that offered annual mammography to women aged 40-49 years. The estimation of the effect of these mammograms on breast cancer and other-cause mortality, and the effect on incidence, with implications for overdiagnosis.
DESIGN
An individually randomised controlled trial comparing offering annual mammography with offering usual care in those aged 40-48 years, and thus evaluating the effect of annual screening entirely taking place before the age of 50 years. There was follow-up for an average of 23 years for breast cancer incidence, breast cancer death and death from other causes. We analysed the mortality and incidence data by Poisson regression and estimated overdiagnosis formally using Markov process models.
SETTING
Twenty-three screening units in England, Wales and Scotland within the NHS Breast Screening Programme.
PARTICIPANTS
Women aged 39-41 years were recruited between 1990 and 1997. After exclusions, a total of 53,883 women were randomised to undergo screening (the intervention group) and 106,953 women were randomised to have usual care (the control group).
INTERVENTIONS
The intervention group was invited to an annual breast screen with film mammography, two view at first screen and single view thereafter, up to and including the calendar year of their 48th birthday. The control group received no intervention. Both groups were invited to the National Programme from the age of 50 years, when screening is offered to all women in the UK.
MAIN OUTCOME MEASURES
The main outcome measures were mortality from breast cancers diagnosed during the intervention phase of the trial (i.e. before the first National Programme screen at 50 years), mortality from all breast cancers diagnosed after randomisation, all-cause mortality, mortality from causes other than breast cancer, and the incidence of breast cancer.
RESULTS
There was a statistically significant 25% reduction in mortality from breast cancers diagnosed during the intervention phase at 10 years' follow-up (relative rate 0.75, 95% confidence interval 0.58 to 0.97; p = 0.03). No reduction was observed thereafter (relative rate 0.98, 95% confidence interval 0.79 to 1.22). Overall, there was a statistically non-significant 12% reduction (relative rate 0.88, 95% confidence interval 0.74 to 1.03; p = 0.1). The absolute benefit remained approximately constant over time, at one death prevented per 1000 women screened. There was no effect of intervention on other-cause mortality (relative rate 1.02, 95% confidence interval 0.97 to 1.07; p = 0.4). The intervention group had a higher incidence of breast cancer than the control group during the intervention phase of the trial, but incidence equalised immediately on the first National Programme screen at the age of 50-52 years.
LIMITATIONS
There was 31% average non-compliance with screening and three centres had to cease screening for resource and capacity reasons.
CONCLUSIONS
Annual mammographic screening at the age of 40-49 years resulted in a relative reduction in mortality, which was attenuated after 10 years. It is likely that digital mammography with two views at all screens, as practised now, could improve this further. There was no evidence of overdiagnosis in addition to that which already results from the National Programme carried out at later ages.
FUTURE WORK
There is a need for research on the effects of modern mammographic protocols and additional imaging in this age group.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN24647151.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 55. See the NIHR Journals Library website for further project information. Other funding in the past has been received from the Medical Research Council, Cancer Research UK, the Department of Health and Social Care, the US National Cancer Institute and the American Cancer Society.",2020,"Overall, there was a statistically non-significant 12% reduction (relative rate 0.88, 95% confidence interval 0.74 to 1.03; p = 0.1).","['women from age 40 years', 'Twenty-three screening units in England, Wales and Scotland within the NHS Breast Screening Programme', 'in those aged 40-48 years, and thus evaluating the effect of annual screening entirely taking place before the age of 50 years', 'Women aged 39-41 years were recruited between 1990 and 1997', '53,883 women were randomised to undergo screening (the intervention group) and 106,953 women', 'women aged 40-49 years', 'Both groups were invited to the National Programme from the age of 50 years, when screening is offered to all women in the UK']","['mammographic screening', 'Annual mammographic screening', 'annual breast screen with film mammography', 'no intervention', 'annual mammography with offering usual care', 'annual mammography']","['mortality from all breast cancers diagnosed after randomisation, all-cause mortality, mortality from causes other than breast cancer, and the incidence of breast cancer', 'mortality from breast cancers diagnosed', 'cause mortality', 'breast cancer mortality', 'incidence of breast cancer', 'breast cancer incidence, breast cancer death and death', 'mortality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",53883.0,0.0961859,"Overall, there was a statistically non-significant 12% reduction (relative rate 0.88, 95% confidence interval 0.74 to 1.03; p = 0.1).","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Duffy', 'Affiliation': 'Centre for Cancer Prevention, Queen Mary University of London, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vulkan', 'Affiliation': 'Centre for Cancer Prevention, Queen Mary University of London, London, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Cuckle', 'Affiliation': 'Department of Obstetrics and Gynaecology, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Dharmishta', 'Initials': 'D', 'LastName': 'Parmar', 'Affiliation': 'Centre for Cancer Prevention, Queen Mary University of London, London, UK.'}, {'ForeName': 'Shama', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': ""Cancer Prevention Group, King's College London, London, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Cancer Screening, American Cancer Society, Atlanta, GA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Evans', 'Affiliation': 'Division of Cancer Research, University of Dundee, Dundee, UK.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Blyuss', 'Affiliation': 'Centre for Cancer Prevention, Queen Mary University of London, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Johns', 'Affiliation': ""Cancer Prevention Group, King's College London, London, UK.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ellis', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Nottingham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sasieni', 'Affiliation': ""Cancer Prevention Group, King's College London, London, UK.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Wale', 'Affiliation': 'Centre for Cancer Prevention, Queen Mary University of London, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Myles', 'Affiliation': 'Centre for Cancer Prevention, Queen Mary University of London, London, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Moss', 'Affiliation': 'Centre for Cancer Prevention, Queen Mary University of London, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24550']
1851,33141936,Effect of low vs. high haemoglobin transfusion trigger on cardiac output in patients undergoing elective vascular surgery: post-hoc analysis of a randomised trial.,"BACKGROUND
During vascular surgery, restricted red-cell transfusion reduces frontal lobe oxygen (ScO 2 ) saturation as determined by near-infrared spectroscopy. We evaluated whether inadequate increase in cardiac output (CO) following haemodilution explains reduction in ScO 2 .
METHODS
This is a post-hoc analysis of data from the Transfusion in Vascular surgery (TV) Trial where patients were randomised on haemoglobin drop below 9.7 g/dL to red-cell transfusion at haemoglobin below 8.0 (low-trigger) vs. 9.7 g/dL (high-trigger). Fluid administration was guided by optimising stroke volume. We compared mean intraoperative levels of CO, haemoglobin, oxygen delivery, and CO at nadir ScO 2 with linear regression adjusted for age, operation type and baseline. Data for forty-six patients randomised before end of surgery were included for analysis.
RESULTS
The low-trigger resulted in a 7.1% lower mean intraoperative haemoglobin level (mean difference, -0.74 g/dl; P<0.001) and reduced volume of red-cell transfused (median [inter-quartile range], 0 [0-300] vs. 450 ml [300-675]; P<0.001) compared with the high-trigger group. Mean CO during surgery was numerically 7.3% higher in the low-trigger compared with the high-trigger group (mean difference, 0.36 L/min; 95% confidence interval (CI.95), -0.05 to 0.78; P=0.092; n=42). At the nadir ScO 2 -level, CO was 11.9% higher in the low-trigger group (mean difference, 0.58 L/min; CI.95, 0.10 to 1.07; P=0.024). No change in oxygen delivery was detected between trial groups (MD, 1.39 dL O2 /min; CI.95, -6.16 to 8.93; P=0.721).
CONCLUSION
Vascular surgical patients exposed to restrictive RBC transfusion elicit the expected increase in CO making it unlikely that their potentially limited cardiac capacity explains the associated ScO 2 decrease.",2020,"Mean CO during surgery was numerically 7.3% higher in the low-trigger compared with the high-trigger group (mean difference, 0.36 L/min; 95% confidence interval (CI.95), -0.05 to 0.78; P=0.092; n=42).","['patients undergoing elective vascular surgery', 'forty-six patients randomised before end of surgery were included for analysis']",['low vs. high haemoglobin transfusion trigger'],"['mean intraoperative haemoglobin level', 'mean intraoperative levels of CO, haemoglobin, oxygen delivery, and CO at nadir ScO', 'reduced volume of red-cell transfused', 'Mean CO during surgery', 'cardiac output (CO', 'oxygen delivery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0042381', 'cui_str': 'Vascular surgery procedure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0549448', 'cui_str': 'Increased hemoglobin'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C2986561', 'cui_str': 'Spindle cell oncocytoma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}]",,0.631241,"Mean CO during surgery was numerically 7.3% higher in the low-trigger compared with the high-trigger group (mean difference, 0.36 L/min; 95% confidence interval (CI.95), -0.05 to 0.78; P=0.092; n=42).","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Møller', 'Affiliation': 'Department of Anaesthesia and Intensive care Naestved-Slagelse-Ringsted, Slagelse Hospital, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Wetterslev', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Shahidi', 'Affiliation': 'Department of Cardiology and Vascular Surgery, Zealand University Hospital Roskilde, Denmark.'}, {'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Hellemann', 'Affiliation': 'Department of Anaesthesia and Intensive care Naestved-Slagelse-Ringsted, Slagelse Hospital, Denmark.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Secher', 'Affiliation': 'Department of Anaesthesia, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Ole B', 'Initials': 'OB', 'LastName': 'Pedersen', 'Affiliation': 'Department of Clinical Immunology, Naestved Hospital, Denmark.'}, {'ForeName': 'Klaus V', 'Initials': 'KV', 'LastName': 'Marcussen', 'Affiliation': 'Department of Anaesthesia and Intensive care Naestved-Slagelse-Ringsted, Slagelse Hospital, Denmark.'}, {'ForeName': 'Benedicte G U', 'Initials': 'BGU', 'LastName': 'Ramsing', 'Affiliation': 'Department of Anaesthesia and Intensive care Naestved-Slagelse-Ringsted, Slagelse Hospital, Denmark.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Mortensen', 'Affiliation': 'Department of Anaesthesia and Intensive care Naestved-Slagelse-Ringsted, Slagelse Hospital, Denmark.'}, {'ForeName': 'Henning B', 'Initials': 'HB', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anaesthesia, Zealand University Hospital Roskilde, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13733']
1852,33141979,AmplifEYE Assisted Colonoscopy Versus Standard Colonoscopy: A Randomized Controlled Study.,"BACKGROUND/AIMS
AmplifEYE is a mucosal exposure device mounted to the tip of colonoscope to improve polyp or adenoma detection. We aim to compare the adenoma detection rates (ADR) of AmplifEYE-assisted colonoscopy (AC) with standard colonoscopy (SC).
METHODS
We performed a randomized controlled trial involving patients aged 50 to 79 who underwent AC or SC in two centers. Procedures were performed by five experienced colonoscopists.
RESULTS
355 patients were recruited, with 334 patients (170 AC and 164 SC) included into analysis. The ADR was numerically higher in AC (47.1%) vs SC (40.9%), p = 0.253. The polyp detection rate (PDR) in AC was 68.2% vs 54.3% in SC, p = 0.009 and serrated polyp detection rate (SDR) in AC was 37.6% vs 20.1% in SC, p < 0.001, both statistically significant higher in the study group. The mean cecal intubation time was shorter with AmplifEYE (8.0 min in AC vs 8.9 min in SC, p = 0.030) and there was no difference in pain score (3 in AC vs 4 in SC, p = 0.121).
CONCLUSIONS
AmplifEYE-assisted colonoscopy significantly improved the PDR and SDR, while the ADR was numerically higher in AC that did not reach statistical significance. Using the device resulted in shorter cecal intubation time and did not cause more pain.",2020,"The mean cecal intubation time was shorter with AmplifEYE (8.0 min in AC vs 8.9 min in SC, p = 0.030) and there was no difference in pain score (3 in AC vs 4 in SC, p = 0.121).
","['355 patients were recruited, with 334 patients (170 AC and 164 SC) included into analysis', 'patients aged 50 to 79 who underwent AC or SC in two centers']","['Colonoscopy Versus Standard Colonoscopy', 'AmplifEYE-assisted colonoscopy (AC) with standard colonoscopy (SC']","['shorter cecal intubation time', 'mean cecal intubation time', 'polyp detection rate (PDR', 'PDR and SDR', 'serrated polyp detection rate (SDR) in AC', 'pain score', 'adenoma detection rates (ADR', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C3266123', 'cui_str': 'Serrated polyp'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",355.0,0.105459,"The mean cecal intubation time was shorter with AmplifEYE (8.0 min in AC vs 8.9 min in SC, p = 0.030) and there was no difference in pain score (3 in AC vs 4 in SC, p = 0.121).
","[{'ForeName': 'Shun Fung', 'Initials': 'SF', 'LastName': 'Sze', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong.'}, {'ForeName': 'Wing I', 'Initials': 'WI', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine & Geriatrics, Our Lady of Maryknoll Hospital, Hong Kong.'}, {'ForeName': 'Wai Chuen', 'Initials': 'WC', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine & Geriatrics, Our Lady of Maryknoll Hospital, Hong Kong.'}, {'ForeName': 'Yee Tak', 'Initials': 'YT', 'LastName': 'Hui', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong.'}, {'ForeName': 'Jodis Ting Wa', 'Initials': 'JTW', 'LastName': 'Lam', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15331']
1853,33142014,Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults.,"Atogepant is a potent, selective, oral calcitonin gene-related peptide (CGRP) receptor antagonist in development for migraine prevention. The chemical structure of atogepant is distinct from previous CGRP receptor antagonists, which were associated with elevated serum alanine aminotransferase (ALT) in clinical trials. Here, we report the safety, tolerability, and pharmacokinetics of a once-daily supratherapeutic dose (170 mg) of atogepant for 28 days from a randomized, double-blind, placebo-controlled phase 1 trial in healthy participants. Overall safety, hepatic safety, and plasma pharmacokinetic parameters were evaluated. Thirty-four participants aged 23-55 years enrolled; 28 (82.4%) completed the study in accordance with the protocol. Multiple doses of 170 mg atogepant for 28 consecutive days were generally well tolerated. All adverse events (AEs; reported in 87.0% of the atogepant group; 72.7%, placebo) were mild in severity except 1 serious AE of subarachnoid hemorrhage due to a bicycle accident and not considered related to treatment. There were 2 discontinuations due to AEs, both with atogepant, 1 considered possibly related to treatment. Over 28 days of treatment, no participant receiving atogepant had an ALT elevation above 1.5× upper limit of normal. Change from baseline in serum ALT levels was not different between atogepant and placebo. Atogepant was rapidly absorbed (median time to maximum plasma concentration, approximately 2 hours) with an apparent terminal half-life of approximately 11 hours, and no evidence of accumulation after once-daily dosing. Overall, atogepant at a high oral dose was safe and well tolerated in healthy participants with no clinically meaningful elevations in ALT.",2020,"Atogepant is a potent, selective, oral calcitonin gene-related peptide (CGRP) receptor antagonist in development for migraine prevention.","['Healthy Adults', 'healthy participants', 'Thirty-four participants aged 23-55 years enrolled; 28 (82.4%) completed the study in accordance with the protocol']",['placebo'],"['ALT elevation', 'safety, tolerability, and pharmacokinetics', 'safe and well tolerated', 'tolerated', 'serum ALT levels', 'Overall safety, hepatic safety, and plasma pharmacokinetic parameters']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036828', 'cui_str': 'SGPT'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",34.0,0.4136,"Atogepant is a potent, selective, oral calcitonin gene-related peptide (CGRP) receptor antagonist in development for migraine prevention.","[{'ForeName': 'K Chris', 'Initials': 'KC', 'LastName': 'Min', 'Affiliation': 'Formerly of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Walter K', 'Initials': 'WK', 'LastName': 'Kraft', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Phung', 'Initials': 'P', 'LastName': 'Bondiskey', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Francheska', 'Initials': 'F', 'LastName': 'Colón-González', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Formerly of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Panebianco', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Mixson', 'Affiliation': 'Formerly of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Marissa F', 'Initials': 'MF', 'LastName': 'Dockendorf', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Catherine Z', 'Initials': 'CZ', 'LastName': 'Matthews', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Boinpally', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}]",Clinical and translational science,['10.1111/cts.12917']
1854,33142016,Effect of nintedanib on lung function in patients with systemic sclerosis-associated interstitial lung disease: further analyses of the SENSCIS trial.,"OBJECTIVE
In the SENSCIS trial in subjects with systemic sclerosis-associated ILD (SSc-ILD), nintedanib reduced the rate of decline in forced vital capacity (FVC) over 52 weeks by 44% versus placebo. We investigated the effects of nintedanib on categorical changes in FVC and other measures of ILD progression.
METHODS
In post-hoc analyses, we assessed the proportions of subjects with categorical changes in FVC % predicted at week 52 and the time to absolute decline in FVC ≥5% predicted or death and absolute decline in FVC ≥10% predicted or death.
RESULTS
A total of 288 subjects received nintedanib and 288 received placebo. At week 52, in subjects treated with nintedanib and placebo, respectively, 55.7% and 66.3% had any decline in FVC % predicted, 13.6% and 20.1% had an FVC decline >5%-≤10% predicted, and 3.5% and 5.2% had an FVC decline >10%-≤15% predicted; 34.5% and 43.8% had a decrease in FVC ≥3.3% predicted (proposed minimal clinically important difference [MCID] for worsening of FVC), while 23.0% and 14.9% had an increase in FVC ≥3.0% predicted (proposed MCID for improvement in FVC). Over 52 weeks, the hazard ratio for an absolute decline in FVC ≥5% predicted or death with nintedanib versus placebo was 0.83 (95% CI: 0.66, 1.06) (P=0.14) and the hazard ratio for an absolute decline in FVC ≥10% predicted was 0.64 (95% CI: 0.43, 0.95); P=0.029.
CONCLUSION
These results suggest that nintedanib has a clinically relevant benefit on the progression of SSc-ILD.",2020,"Over 52 weeks, the hazard ratio for an absolute decline in FVC ≥5% predicted or death with nintedanib versus placebo was 0.83 (95% CI: 0.66, 1.06) (P=0.14) and the hazard ratio for an absolute decline in FVC ≥10% predicted was 0.64 (95% CI: 0.43, 0.95); P=0.029.
","['subjects with systemic sclerosis-associated ILD (SSc-ILD', 'patients with systemic sclerosis-associated interstitial lung disease', '288 subjects received nintedanib and 288 received']","['nintedanib and placebo', 'placebo', 'nintedanib']","['lung function', 'FVC decline']","[{'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}]",288.0,0.283625,"Over 52 weeks, the hazard ratio for an absolute decline in FVC ≥5% predicted or death with nintedanib versus placebo was 0.83 (95% CI: 0.66, 1.06) (P=0.14) and the hazard ratio for an absolute decline in FVC ≥10% predicted was 0.64 (95% CI: 0.43, 0.95); P=0.029.
","[{'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'National Heart and Lung Institute, Imperial College London and National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Maureen D', 'Initials': 'MD', 'LastName': 'Mayes', 'Affiliation': 'Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, Texas, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Care Medicine, University of Heidelberg and German Center for Lung Research, Germany.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Volkmann', 'Affiliation': 'Department of Medicine, Division of Rheumatology, University of California, David Geffen School of Medicine, Los Angeles, California, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Aringer', 'Affiliation': 'Division of Rheumatology, Department of Medicine III, University Medical Center & Faculty of Medicine Carl Gustav Carus, TU, Dresden, Dresden, Germany.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Castellvi', 'Affiliation': 'Department of Rheumatology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Cutolo', 'Affiliation': 'Research Laboratory and Academic Unit of Clinical Rheumatology, Department of Internal Medicine, University of Genova, IRCCS San Martino Polyclinic Hospital, Genova, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stock', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Schoof', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Margarida', 'Initials': 'M', 'LastName': 'Alves', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'University of Washington, Seattle, Washington, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41576']
1855,33142694,Mini-Basketball Training Program Improves Social Communication and White Matter Integrity in Children with Autism.,"Impairments in social communication (SC) represent one of the core symptoms of autism spectrum disorder (ASD). While previous studies have demonstrated that exercise intervention improves SC in children with ASD, there is currently no neuroscientific evidence supporting its benefits. Therefore, we evaluated the outcomes of a long-term exercise intervention on SC and white matter integrity (WMI) in children with ASD, and further explored the neural mechanism of exercise intervention on SC in these children. Twenty-nine children aged 3-6 years with ASD were assigned to either exercise group ( n = 15) or control group ( n = 14). The exercise group received a scheduled mini-basketball training program (5 sessions per week, forty minutes per session) for 12 consecutive weeks, while the control group was instructed to maintain their daily activities. Groups were assessed before and after intervention on SC and WMI. SC scores were lower in the exercise group post-intervention. Compared with the control group, WMI of the exercise group showed higher fractional anisotropy in the body of corpus callosum, fornix, right cerebral peduncle, left posterior limb of internal capsule, right retrolenticular part of internal capsule, left anterior corona radiate and left superior fronto-occipital fasciculus; lower mean diffusivity in the left anterior corona radiate and the bilateral corticospinal tract. Furthermore, increased WMI was associated with lower scores on a measure of social cognition in the overall sample. This study is the first to provide evidence that exercise intervention improves SC and white matter integrity in children with autism.",2020,"Compared with the control group, WMI of the exercise group showed higher fractional anisotropy in the body of corpus callosum, fornix, right cerebral peduncle, left posterior limb of internal capsule, right retrolenticular part of internal capsule, left anterior corona radiate and left superior fronto-occipital fasciculus; lower mean diffusivity in the left anterior corona radiate and the bilateral corticospinal tract.","['Children with Autism', 'children with autism', 'Twenty-nine children aged 3-6 years with ASD', 'children with ASD']","['exercise group ( n = 15) or control group', 'exercise intervention', 'Mini-Basketball Training Program', 'scheduled mini-basketball training program', 'long-term exercise intervention']","['body of corpus callosum, fornix, right cerebral peduncle, left posterior limb of internal capsule, right retrolenticular part of internal capsule, left anterior corona radiate', 'Social Communication and White Matter Integrity', 'SC scores', 'social cognition', 'WMI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0152320', 'cui_str': 'Structure of body of corpus callosum'}, {'cui': 'C0152334', 'cui_str': 'Cerebral fornix structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0007793', 'cui_str': 'Cerebral peduncle structure'}, {'cui': 'C0456856', 'cui_str': 'Left posterior'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0152341', 'cui_str': 'Internal capsule structure'}, {'cui': 'C0441998', 'cui_str': 'Left anterior'}, {'cui': 'C0332301', 'cui_str': 'Radiating to'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",29.0,0.0173475,"Compared with the control group, WMI of the exercise group showed higher fractional anisotropy in the body of corpus callosum, fornix, right cerebral peduncle, left posterior limb of internal capsule, right retrolenticular part of internal capsule, left anterior corona radiate and left superior fronto-occipital fasciculus; lower mean diffusivity in the left anterior corona radiate and the bilateral corticospinal tract.","[{'ForeName': 'Kelong', 'Initials': 'K', 'LastName': 'Cai', 'Affiliation': 'College of Physical Education, Yangzhou University, Yangzhou 225127, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Exercise and Mental Health Laboratory, Institute of Mental Health, School of Psychology, Shenzhen University, Shenzhen 518060, China.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Herold', 'Affiliation': 'Research Group Neuroprotection, German Center for Neurodegenerative Diseases (DZNE), Leipziger Str. 44, 39120 Magdeburg, Germany.'}, {'ForeName': 'Zhimei', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'College of Physical Education, Yangzhou University, Yangzhou 225127, China.'}, {'ForeName': 'Jingui', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'College of Physical Education, Yangzhou University, Yangzhou 225127, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'School of Physical Education and Sports Science, Beijing Normal University, Beijing 100875, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Xiong', 'Affiliation': 'College of Physical Education, Yangzhou University, Yangzhou 225127, China.'}, {'ForeName': 'Aiguo', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'College of Physical Education, Yangzhou University, Yangzhou 225127, China.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Müller', 'Affiliation': 'Research Group Neuroprotection, German Center for Neurodegenerative Diseases (DZNE), Leipziger Str. 44, 39120 Magdeburg, Germany.'}, {'ForeName': 'Arthur F', 'Initials': 'AF', 'LastName': 'Kramer', 'Affiliation': 'Center for Cognitive and Brain Health, Department of Psychology, Northeastern University, Boston, MA 02115, USA.'}, {'ForeName': 'Notger G', 'Initials': 'NG', 'LastName': 'Müller', 'Affiliation': 'Research Group Neuroprotection, German Center for Neurodegenerative Diseases (DZNE), Leipziger Str. 44, 39120 Magdeburg, Germany.'}, {'ForeName': 'Liye', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Exercise and Mental Health Laboratory, Institute of Mental Health, School of Psychology, Shenzhen University, Shenzhen 518060, China.'}]",Brain sciences,['10.3390/brainsci10110803']
1856,33142834,Effectiveness of Heel-Raise-Lower Exercise after Transcutaneous Electrical Nerve Stimulation in Patients with Stroke: A Randomized Controlled Study.,"OBJECTIVE
This study was conducted to investigate the effect of the heel-raise-lower exercise on spasticity, strength, and gait speed after the application of 30 min of transcutaneous electrical nerve stimulation (TENS) in patients with stroke.
METHODS
The participants were randomly divided into the TENS group and the placebo group, with 20 participants assigned to each group. In the TENS group, heel-raise-lower exercise was performed after applying TENS for six weeks. The placebo group was trained in the same manner for the same amount of time but without electrical stimulation. The spasticity of the ankle plantar flexors was measured using the composite spasticity score. A handheld dynamometer and a 10-m walk test were used to evaluate muscle strength and gait speed, respectively.
RESULTS
Spasticity was significantly more improved in the TENS group (mean change -2.0 ± 1.1) than in the placebo group (mean change -0.4 ± 0.9) ( p < 0.05). Similarly, muscle strength was significantly more improved in the TENS group (6.4 ± 3.3 kg) than in the placebo group (4.5 ± 1.6 kg) ( p < 0.05). Moreover, participants assigned to the TENS group showed a significant greater improvement in gait speed than those in the placebo group (mean change -5.3 ± 1.4 s vs. -2.7 ± 1.2 s).
CONCLUSIONS
These findings show the benefits of heel-raise-lower exercise after TENS for functional recovery in patients with stroke.",2020,"RESULTS
Spasticity was significantly more improved in the TENS group (mean change -2.0 ± 1.1) than in the placebo group (mean change -0.4 ± 0.9) ( p < 0.05).","['Patients with Stroke', 'patients with stroke']","['heel-raise-lower exercise', 'transcutaneous electrical nerve stimulation (TENS', 'placebo', 'Heel-Raise-Lower Exercise after Transcutaneous Electrical Nerve Stimulation', 'heel-raise-lower exercise after TENS', 'TENS']","['heel-raise-lower exercise', 'muscle strength', 'spasticity, strength, and gait speed', 'muscle strength and gait speed, respectively', 'gait speed', 'Spasticity', 'spasticity of the ankle plantar flexors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}]",,0.135535,"RESULTS
Spasticity was significantly more improved in the TENS group (mean change -2.0 ± 1.1) than in the placebo group (mean change -0.4 ± 0.9) ( p < 0.05).","[{'ForeName': 'Kyoung-Sim', 'Initials': 'KS', 'LastName': 'Jung', 'Affiliation': 'Department of Physical Therapy, Gimcheon University, Gimcheon 39528, Korea.'}, {'ForeName': 'Jin-Hwa', 'Initials': 'JH', 'LastName': 'Jung', 'Affiliation': 'Department of Occupational Therapy, Semyung University, Jecheon 27136, Korea.'}, {'ForeName': 'Tae-Sung', 'Initials': 'TS', 'LastName': 'In', 'Affiliation': 'Department of Physical Therapy, Gimcheon University, Gimcheon 39528, Korea.'}, {'ForeName': 'Hwi-Young', 'Initials': 'HY', 'LastName': 'Cho', 'Affiliation': 'Department of Physical Therapy, Gachon University, Incheon 21936, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9113532']
1857,33145609,Comparing less invasive plate fixation versus screw fixation of displaced intra-articular calcaneus fracture via sinus tarsi approach.,"PURPOSE
The purpose of this study was to compare the post-operative radiographic and clinical outcomes of less invasive plate fixation versus screw fixation of displaced intra-articular calcaneus fractures (DIACFs) via sinus tarsi approach.
METHODS
A total of 165 consecutive DIACFs that underwent open reduction internal fixation via sinus tarsi approach from 2013 to 2018 were reviewed at least a two year follow-up. The methods of fixation were divided into two groups: less invasive plate fixation versus screw fixation of calcaneus fracture (59 vs 106, respectively). The radiographic outcomes including pre- and post-operative Bohler's and Gissane's angles were evaluated. The post-operative function was evaluated using the American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score, the Olerud and Molander Scale and the Visual Analogue Scale (VAS). The complications, the rates of implant removal and cost were also compared.
RESULTS
The average follow-up was 44.2 months in the plate groups and 47.9 months in the screw groups (P > 0.05). There was no significant difference in the Bohler's angle and Gissane's angle between the plate group and screw group during the pre-operation and the last follow-up. There was no significant difference in the final AOFAS score, Olerud and Molander score and VAS score between the two groups (P > 0.05). The total incidence of complications was 6.7% in the plate group and 6.6% in the screw group (P > 0.05). The rates of implant removal and total cost during the hospitalization in the plate group were significantly higher compared with screws group (P < 0.05).
CONCLUSION
The less invasive plate fixation versus screw fixation of DIACFs via sinus tarsi approach contributed comparable quality of reduction, complications and post-operative functional outcomes. The less invasive plate technique was significantly higher in terms of implant costs and the rate of implant removal.",2020,There was no significant difference in the Bohler's angle and Gissane's angle between the plate group and screw group during the pre-operation and the last follow-up.,['A total of 165 consecutive DIACFs that underwent open reduction internal fixation via sinus tarsi approach from 2013 to 2018 were reviewed at least a two\xa0year follow-up'],"['invasive plate fixation versus screw fixation', 'invasive plate fixation versus screw fixation of calcaneus fracture', 'invasive plate fixation versus screw fixation of displaced intra-articular calcaneus fractures (DIACFs']","['final AOFAS score, Olerud and Molander score and VAS score', ""radiographic outcomes including pre- and post-operative Bohler's and Gissane's angles"", 'rates of implant removal and cost', 'rates of implant removal and total cost during the hospitalization', 'total incidence of complications', 'American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score, the Olerud and Molander Scale and the Visual Analogue Scale (VAS', 'invasive plate technique']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0281926', 'cui_str': 'Fracture of calcaneus'}, {'cui': 'C1297885', 'cui_str': 'Open reduction with internal fixation'}, {'cui': 'C4082813', 'cui_str': 'Sinus Tarsi'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0281926', 'cui_str': 'Fracture of calcaneus'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0561946', 'cui_str': 'Removal of implant'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0230459', 'cui_str': 'Hindfoot'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",,0.0182627,There was no significant difference in the Bohler's angle and Gissane's angle between the plate group and screw group during the pre-operation and the last follow-up.,"[{'ForeName': 'Changjun', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Department of Orthopaedics, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yangbo', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Bone and Joint Surgery, Hospital of Southwest Medical University, Luzhou, China.'}, {'ForeName': 'Chunguang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xingchen', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhengxiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedics, Zhangjiagang Fifth People's Hospital, Zhangjiagang, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': 'Department of Orthopaedics, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. 1967869239@qq.com.'}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. xu664531@126.com.'}]",International orthopaedics,['10.1007/s00264-020-04867-5']
1858,33145642,"A randomised, single-blind, placebo-controlled, dose-finding safety and tolerability study of the anti-CD3 monoclonal antibody otelixizumab in new-onset type 1 diabetes.","AIMS/HYPOTHESIS
Numerous clinical studies have investigated the anti-CD3ɛ monoclonal antibody otelixizumab in individuals with type 1 diabetes, but limited progress has been made in identifying the optimal clinical dose with acceptable tolerability and safety. The aim of this study was to evaluate the association between dose-response, safety and tolerability, beta cell function preservation and the immunological effects of otelixizumab in new-onset type 1 diabetes.
METHODS
In this randomised, single-blind, placebo-controlled, 24 month study, conducted in five centres in Belgium via the Belgian Diabetes Registry, participants (16-27 years old, <32 days from diagnosis of type 1 diabetes) were scheduled to receive placebo or otelixizumab in one of four dose cohorts (cumulative i.v. dose 9, 18, 27 or 36 mg over 6 days; planned n = 40). Randomisation to treatment was by a central computer system; only participants and bedside study personnel were blinded to study treatment. The co-primary endpoints were the incidence of adverse events, the rate of Epstein-Barr virus (EBV) reactivation, and laboratory measures and vital signs. A mixed-meal tolerance test was used to assess beta cell function; exploratory biomarkers were used to measure T cell responses.
RESULTS
Thirty participants were randomised/28 were analysed (placebo, n = 6/5; otelixizumab 9 mg, n = 9/8; otelixizumab 18 mg, n = 8/8; otelixizumab 27 mg, n = 7/7; otelixizumab 36 mg, n = 0). Dosing was stopped at otelixizumab 27 mg as the predefined EBV reactivation stopping criteria were met. Adverse event frequency and severity were dose dependent; all participants on otelixizumab experienced at least one adverse event related to cytokine release syndrome during the dosing period. EBV reactivation (otelixizumab 9 mg, n = 2/9; 18 mg, n = 4/8: 27 mg, n = 5/7) and clinical manifestations (otelixizumab 9 mg, n = 0/9; 18 mg, n = 1/8; 27 mg, n = 3/7) were rapid, dose dependent and transient, and were associated with increased productive T cell clonality that diminished over time. Change from baseline mixed-meal tolerance test C-peptide weighted mean AUC 0-120 min following otelixizumab 9 mg was above baseline for up to 18 months (difference from placebo 0.39 [95% CI 0.06, 0.72]; p = 0.023); no beta cell function preservation was observed at otelixizumab 18 and 27 mg.
CONCLUSIONS/INTERPRETATION
A metabolic response was observed with otelixizumab 9 mg, while doses higher than 18 mg increased the risk of unwanted clinical EBV reactivation. Although otelixizumab can temporarily compromise immunocompetence, allowing EBV to reactivate, the effect is dose dependent and transient, as evidenced by a rapid emergence of EBV-specific T cells preceding long-term control over EBV reactivation.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02000817.
FUNDING
The study was funded by GlaxoSmithKline. Graphical abstract.",2020,Adverse event frequency and severity were dose dependent; all participants on otelixizumab experienced at least one adverse event related to cytokine release syndrome during the dosing period.,"['Thirty participants were randomised/28 were analysed', '24\xa0month study, conducted in five centres in Belgium via the Belgian Diabetes Registry, participants (16-27\xa0years old, <32\xa0days from diagnosis of type 1 diabetes', 'individuals with type 1 diabetes', 'new-onset type 1 diabetes']","['placebo', 'otelixizumab 9\xa0mg, n\u2009=\u20099/8; otelixizumab 18\xa0mg, n\u2009=\u20098/8; otelixizumab 27\xa0mg, n\u2009=\u20097/7; otelixizumab 36\xa0mg, n\u2009=\u20090', 'placebo or otelixizumab', 'otelixizumab', 'EBV reactivation (otelixizumab 9\xa0mg, n\u2009', 'anti-CD3 monoclonal antibody otelixizumab']","['productive T cell clonality', 'no beta cell function preservation', 'risk of unwanted clinical EBV reactivation', 'safety and tolerability, beta cell function preservation', 'metabolic response', 'incidence of adverse events, the rate of Epstein-Barr virus (EBV) reactivation, and laboratory measures and vital signs']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2935224', 'cui_str': 'otelixizumab'}, {'cui': 'C0651569', 'cui_str': ""9-(1'-hydroxy-2'-(hydroxymethyl)ethoxy)methylguanine""}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0085379', 'cui_str': 'Muromonab-CD3'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",30.0,0.233585,Adverse event frequency and severity were dose dependent; all participants on otelixizumab experienced at least one adverse event related to cytokine release syndrome during the dosing period.,"[{'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Keymeulen', 'Affiliation': 'Academic Hospital and Diabetes Research Center, Vrije Universiteit Brussel, Brussels, Belgium. bart.keymeulen@vub.be.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'van Maurik', 'Affiliation': 'GlaxoSmithKline Medicines Research Centre, Stevenage, UK.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Inman', 'Affiliation': 'GlaxoSmithKline Medicines Research Centre, Stevenage, UK.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Oliveira', 'Affiliation': 'GlaxoSmithKline, Global Clinical Operations, Cambridge, UK.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'McLaughlin', 'Affiliation': 'Department of Immunology and Blood Transfusion, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Gittelman', 'Affiliation': 'Adaptive Biotechnologies, Seattle, WA, USA.'}, {'ForeName': 'Bart O', 'Initials': 'BO', 'LastName': 'Roep', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Gillard', 'Affiliation': 'Department of Endocrinology, University Hospitals Leuven-KUL, Leuven, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hilbrands', 'Affiliation': 'Academic Hospital and Diabetes Research Center, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Gorus', 'Affiliation': 'Academic Hospital and Diabetes Research Center, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Department of Endocrinology, University Hospitals Leuven-KUL, Leuven, Belgium.'}, {'ForeName': 'Ursule', 'Initials': 'U', 'LastName': 'Van de Velde', 'Affiliation': 'Academic Hospital and Diabetes Research Center, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Wisniacki', 'Affiliation': 'GlaxoSmithKline Medicines Research Centre, Stevenage, UK.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Napolitano', 'Affiliation': 'GlaxoSmithKline Medicines Research Centre, Stevenage, UK. Antonella.2.napolitano@gsk.com.'}]",Diabetologia,['10.1007/s00125-020-05317-y']
1859,33145643,Effect of the intake of dietary protein on insulin resistance in subjects with obesity: a randomized controlled clinical trial.,"PURPOSE
We compared the effect of diets with different amounts and sources of dietary protein on insulin sensitivity (IS) in subjects with obesity and insulin resistance (IR).
METHODS
Eighty subjects with obesity (BMI ≥ 30 kg/m 2 ) and IR (Matsuda index < 4.3 and HOMA-IR ≥ 2.5) over 18 years old were randomized to four groups for a one-month period: a normal protein diet (< 20%) with a predominance of animal protein (Animal NP) or vegetable protein (Vegetable NP) and a high-protein diet (25-30%) with a predominance of animal protein (Animal HP) or vegetable protein (Vegetable HP). Baseline and final measurements of body weight, body composition, biochemical parameters, blood pressure (BP), resting energy expenditure and plasma amino acid profiles were performed.
RESULTS
Body weight, BMI and waist circumference decreased in all groups. Interestingly, the IS improved more in the Animal HP (Matsuda index; 1.39 vs 2.58, P = 0.003) and in the Vegetable HP groups (Matsuda index; 1.44 vs 3.14, P < 0.0001) after one month. The fat mass, triglyceride levels, C-reactive protein levels and the leptin/adiponectin index decreased; while, the skeletal muscle mass increased in the Animal and Vegetable HP groups. The BP decreased in all groups except the Animal NP group.
CONCLUSION
Our study demonstrates that a high-protein hypocaloric diets improves IS by 60-90% after one month in subjects with obesity and IR, regardless of weight loss and the source of protein, either animal or vegetable.
TRIAL REGISTRATION
The trial is registered at clinicaltrials.gov (NCT03627104), August 13, 2018.",2020,"The fat mass, triglyceride levels, C-reactive protein levels and the leptin/adiponectin index decreased; while, the skeletal muscle mass increased in the Animal and Vegetable HP groups.","['Eighty subjects with obesity (BMI\u2009≥\u200930\xa0kg/m 2 ) and IR (Matsuda index\u2009<\u20094.3 and HOMA-IR\u2009≥\u20092.5) over 18\xa0years old', 'subjects with obesity', 'subjects with obesity and insulin resistance (IR']","['high-protein hypocaloric diets', 'normal protein diet (<\u200920%) with a predominance of animal protein (Animal NP) or vegetable protein (Vegetable NP) and a high-protein diet (25-30%) with a predominance of animal protein (Animal HP) or vegetable protein (Vegetable HP', 'dietary protein']","['fat mass, triglyceride levels, C-reactive protein levels and the leptin/adiponectin index', 'skeletal muscle mass', 'insulin resistance', 'Body weight, BMI and waist circumference', 'body weight, body composition, biochemical parameters, blood pressure (BP), resting energy expenditure and plasma amino acid profiles', 'BP']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0860902', 'cui_str': 'Protein NOS normal'}, {'cui': 'C0440447', 'cui_str': 'Animal protein'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0042439', 'cui_str': 'Dietary Plant Proteins'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}]",80.0,0.0288331,"The fat mass, triglyceride levels, C-reactive protein levels and the leptin/adiponectin index decreased; while, the skeletal muscle mass increased in the Animal and Vegetable HP groups.","[{'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'González-Salazar', 'Affiliation': 'Department of Nutrition Physiology, Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Pichardo-Ontiveros', 'Affiliation': 'Department of Nutrition Physiology, Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Berenice', 'Initials': 'B', 'LastName': 'Palacios-González', 'Affiliation': 'Scientific Bonding Unit, Medicine Faculty UNAM-INMEGEN, Mexico City, Mexico.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Vigil-Martínez', 'Affiliation': 'Department of Nutrition Physiology, Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Granados-Portillo', 'Affiliation': 'Department of Nutrition Physiology, Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Guizar-Heredia', 'Affiliation': 'Department of Nutrition Physiology, Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Flores-López', 'Affiliation': 'Department of Nutrition Physiology, Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Medina-Vera', 'Affiliation': 'Research Methodology Department, Instituto Nacional de Pediatría, Mexico City, Mexico.'}, {'ForeName': 'Pamela K', 'Initials': 'PK', 'LastName': 'Heredia-G-Cantón', 'Affiliation': 'Department of Nutrition Physiology, Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Karla G', 'Initials': 'KG', 'LastName': 'Hernández-Gómez', 'Affiliation': 'Department of Nutrition Physiology, Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Castelán-Licona', 'Affiliation': 'Obesity Clinic, Hospital General Tláhuac, Mexico City, Mexico.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Arteaga-Sánchez', 'Affiliation': 'Department of Nutrition Physiology, Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Aurora E', 'Initials': 'AE', 'LastName': 'Serralde-Zúñiga', 'Affiliation': 'Clinical Nutrition Service, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Azalia', 'Initials': 'A', 'LastName': 'Ávila-Nava', 'Affiliation': 'Hospital Regional de Alta Especialidad de la Península de Yucatán, Mérida, Mexico.'}, {'ForeName': 'Lilia G', 'Initials': 'LG', 'LastName': 'Noriega-López', 'Affiliation': 'Department of Nutrition Physiology, Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Juan G', 'Initials': 'JG', 'LastName': 'Reyes-García', 'Affiliation': 'Sección de Estudios de Posgrado e Investigación, Escuela Superior de Medicina, Instituto Politécnico Nacional, Mexico City, Mexico.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zerrweck', 'Affiliation': 'Obesity Clinic, Hospital General Tláhuac, Mexico City, Mexico.'}, {'ForeName': 'Nimbe', 'Initials': 'N', 'LastName': 'Torres', 'Affiliation': 'Department of Nutrition Physiology, Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Armando R', 'Initials': 'AR', 'LastName': 'Tovar', 'Affiliation': 'Department of Nutrition Physiology, Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City, Mexico. tovar.ar@gmail.com.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Guevara-Cruz', 'Affiliation': 'Department of Nutrition Physiology, Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City, Mexico. marthaguevara8@yahoo.com.mx.'}]",European journal of nutrition,['10.1007/s00394-020-02428-5']
1860,33145654,Undergraduate Curriculum Designed to Facilitate a Cancer Exercise Rehabilitation Program.,"In 2030, more than 22.1 million cancer survivors are expected to reside in the USA. A workforce knowledgeable in the unique issues of oncologic exercise design and delivery will help to fulfill the need for services that improve survivor health, prognosis, and quality of life (QOL). The purpose of this project was to describe the application of a cancer exercise rehabilitation training program on student performance benchmarks and patient outcomes. Thirty-seven kinesiology students were taught how to design an exercise program for cancer patients through face-to-face instruction (10 h) and online material. Students created and delivered exercise prescriptions to cancer patients (n = 111) over 12 weeks. Surveys evaluating student performance, patient fitness, and patient psychosocial outcomes were used to assess students' skill proficiency, ability to apply newly acquired knowledge, and academic/professional growth. A 2-way ANOVA evaluating student performance scores revealed a significant main effect of time (F(1, 165) = 22.92, p < 0.001), indicating that student performance was improved. Post hoc tests showed the ""skill proficiency, knowledge and exercise leadership"" dimension was significantly improved (p < 0.0001). Cancer patients had significant improvements in body composition, muscular function, flexibility, and balance (p < 0.05). Students succeeded in tasks directly related to content learned in prerequisite kinesiology courses, while 3 weeks was required for students to become proficient in clinic-related duties. Ninety percent of the students reported that the internship was an excellent learning experience. The curriculum was successful in teaching students how to design and implement exercise programs that improve cancer patient fitness and QOL.",2020,"Cancer patients had significant improvements in body composition, muscular function, flexibility, and balance (p < 0.05).","['Thirty-seven kinesiology students', 'In 2030, more than 22.1 million cancer survivors', 'Cancer patients']","['exercise program for cancer patients through face-to-face instruction (10\xa0h) and online material', 'cancer exercise rehabilitation training program']","['survivor health, prognosis, and quality of life (QOL', ""students' skill proficiency, ability to apply newly acquired knowledge, and academic/professional growth"", 'body composition, muscular function, flexibility, and balance', 'cancer patient fitness and QOL', 'skill proficiency, knowledge and exercise leadership"" dimension']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",,0.0251957,"Cancer patients had significant improvements in body composition, muscular function, flexibility, and balance (p < 0.05).","[{'ForeName': 'Paulette M', 'Initials': 'PM', 'LastName': 'Yamada', 'Affiliation': ""Department of Kinesiology and Rehabilitation Science (KRS), University of Hawai'i at Mānoa, 1337 Lower Campus Road PE/A 231, Honolulu, HI, 96822, USA. pyamada@hawaii.edu.""}, {'ForeName': 'Cheri', 'Initials': 'C', 'LastName': 'Teranishi-Hashimoto', 'Affiliation': 'Rehabilitation Hospital of the Pacific, 226 North Kuakini Street, Honolulu, HI, 96817, USA.'}, {'ForeName': 'Ariimana', 'Initials': 'A', 'LastName': 'Temanaha', 'Affiliation': ""Department of Kinesiology and Rehabilitation Science (KRS), University of Hawai'i at Mānoa, 1337 Lower Campus Road PE/A 231, Honolulu, HI, 96822, USA.""}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01913-z']
1861,33145864,"The Effects of Elaeagnus angustifolia L. On Lipid and Glycemic Profiles and Cardiovascular Function in Menopausal Women: A Double-Blind, Randomized, Placebo-Controlled Study.","AIMS
The reduced production of ovarian hormones is considered to be the cause of an increase in the incidence of heart disease in women after menopause. Phytoestrogens are found in various herbal sources and are considered as an alternative to hormone therapy due to structural similarity with estrogen. Elaeagnus angustifolia L., known as Senjed in Persian, is used in Iranian traditional medicine with various medicinal properties, contains valuable compounds, including two types of phytoestrogens. The aim of the present study was to investigate the efficacy of E. angustifolia fruit on the cardiovascular function, lipid and glycemic profiles in postmenopausal women.
METHODS
In this double-blind placebo-controlled clinical trial, 58 postmenopausal women were randomly assigned into two experimental groups of medicinal herb (15 g/day of the whole E. angustifolia fruit powder) and placebo (15 g/day of isomalt + corn starch). Before the trial and after 10 weeks of the treatment, cardiovascular function (heart rate, blood pressure), serum glycemic profile (fasting blood glucose; glycated hemoglobin, HbA1C), insulin, and lipid profile (total cholesterol, TC; triglyceride, TG; LDL-C and HDL-C) were measured.
RESULTS
Heart rate, and serum level of LDL-C and HDL-C significantly decreased after treatment with E. angustifolia. Changes in glycemic profile were not clinically significant. In addition, some studied biochemical parameters significantly changed in the placebo group.
CONCLUSIONS
E. angustifolia was somewhat effective in improving cardiovascular function and lipid profile, as well as the overall health of postmenopausal women. However, the use of isomalt and corn starch in menopausal women needs further investigation.",2020,"RESULTS
Heart rate, and serum level of LDL-C and HDL-C significantly decreased after treatment with E. angustifolia.","['Menopausal Women', 'postmenopausal women', '58 postmenopausal women']","['Elaeagnus angustifolia L', 'angustifolia fruit', 'medicinal herb', 'placebo', 'isomalt and corn starch', 'Placebo']","['glycemic profile', 'cardiovascular function (heart rate, blood pressure), serum glycemic profile (fasting blood glucose; glycated hemoglobin, HbA1C), insulin, and lipid profile (total cholesterol, TC; triglyceride, TG; LDL-C and HDL-C', 'Heart rate, and serum level of LDL-C and HDL-C', 'cardiovascular function, lipid and glycemic profiles', 'cardiovascular function and lipid profile']","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0283192', 'cui_str': 'ISOMALT'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}]","[{'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",58.0,0.171299,"RESULTS
Heart rate, and serum level of LDL-C and HDL-C significantly decreased after treatment with E. angustifolia.","[{'ForeName': 'Mahzad', 'Initials': 'M', 'LastName': 'Shabani', 'Affiliation': 'School of Biology, Damghan University, Damghan, Iran.'}, {'ForeName': 'Arezou', 'Initials': 'A', 'LastName': 'Rezaei', 'Affiliation': 'School of Biology, Damghan University, Damghan, Iran.'}, {'ForeName': 'Bita', 'Initials': 'B', 'LastName': 'Badehnoosh', 'Affiliation': 'Department of Gynecology and Obstetrics, Faculty of Medical Science, Alborz University of Medical Science, Karaj, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Qorbani', 'Affiliation': 'Non-Communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Rohollah', 'Initials': 'R', 'LastName': 'Ramezani', 'Affiliation': 'Department of Statistic, Faculty of Mathematics and Computer Science, Damghan University, Damghan, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Emaminia', 'Affiliation': 'School of Biology, Damghan University, Damghan, Iran.'}]",International journal of clinical practice,['10.1111/ijcp.13812']
1862,33145920,The influence of reviewer's occupation on the skill assessment of urethrovesical anastomosis in robot-assisted radical prostatectomy.,"INTRODUCTION
In recent years, crowd-sourced assessments have been reported as a timesaving, cost-efficient, and practicable method of surgical skill evaluation. However, the differences in the assessment of surgical skills by the individual reviewers cannot be further examined in terms of characteristics of the reviewers because they are usually anonymously and randomly selected. This study aimed to reveal the effects of reviewers' occupations on their assessment of a surgeon's skill.
METHODS
In total, 42 urologists, 19 paramedics, 73 medical students, and 28 non-medical personnel used the Global Evaluative Assessment of Robotic Skills (GEARS) validated robotic surgery rating tool to assess the surgical skill of surgeons in nine edited video clips of complete urethrovesical anastomosis during a robot-assisted radical prostatectomy. The total GEARS scores of the four groups of reviewers were compared, and the similarities and the differences between the ratings of the urologists group and those of the other three groups were subsequently investigated.
RESULTS
The rankings of video clips in the order of GEARS scores were very similar in each group, and a strong positive correlation (R 2 values >0.8) was observed between the scores assigned by the urologists group and those assigned by the other three groups.
CONCLUSION
Our findings indicate that the crude evaluation of robot-assisted urethrovesical anastomosis is not affected by the reviewers' occupations. Non-medical personnel may be able to provide a rudimentary screening evaluation of surgical skill.",2020,Our findings indicate that the crude evaluation of robot-assisted urethrovesical anastomosis is not affected by the reviewers' occupations. Non-medical personnel may be able to provide a rudimentary screening evaluation of surgical skill.,"['In total, 42 urologists, 19 paramedics, 73 medical students, and 28 non-medical personnel used the']","['Global Evaluative Assessment of Robotic Skills (GEARS) validated robotic surgery rating tool to assess the surgical skill of surgeons in nine edited video clips of complete urethrovesical anastomosis during a robot-assisted radical prostatectomy', 'robot-assisted radical prostatectomy']","['total GEARS scores', 'GEARS scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0260314', 'cui_str': 'Urologist'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",73.0,0.0411137,Our findings indicate that the crude evaluation of robot-assisted urethrovesical anastomosis is not affected by the reviewers' occupations. Non-medical personnel may be able to provide a rudimentary screening evaluation of surgical skill.,"[{'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Fukuoka', 'Affiliation': 'Department of Urology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Teishima', 'Affiliation': 'Department of Urology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Inoue', 'Affiliation': 'Department of Urology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Tetsutaro', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Urology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Matsubara', 'Affiliation': 'Department of Urology, Hiroshima General Hospital, Hatsukaichi, Japan.'}]",Asian journal of endoscopic surgery,['10.1111/ases.12892']
1863,33145944,Long-Term Efficacy and Safety of Dapagliflozin in Patients with Inadequately Controlled Type 1 Diabetes: Pooled 52-Week Outcomes from the DEPICT-1 and -2 Studies.,"AIMS
This pooled analysis of the DEPICT-1 and -2 trials aimed to evaluate the efficacy and safety of adjunct dapagliflozin therapy in patients with type 1 diabetes (T1D).
MATERIALS AND METHODS
DEPICT-1 and -2 were randomized, double-blind, parallel-group, 24-week studies, with 28-week extension periods. Adults with T1D and HbA1c 7.5-10.5% were randomized (1:1:1) to receive dapagliflozin 5, 10 mg or placebo. The short- and long-term efficacy and safety of dapagliflozin were examined in an exploratory pooled analysis of both studies.
RESULTS
Efficacy analyses included 530, 529 and 532 and safety analysis included 548, 566 and 532 patients in the dapagliflozin 5 mg, 10 mg and placebo groups, respectively. Baseline characteristics were similar between treatment groups. At Week 24, reductions were seen with dapagliflozin 5 and 10 mg compared with placebo in HbA1c (-0.40%, -0.43% vs 0.00%) and body weight (-2.45, -2.91 vs 0.11 kg). HbA1c and body weight reductions versus placebo were also seen after 52 weeks of treatment. There was no imbalance in occurrence of severe hypoglycaemic events between groups. The proportion of patients experiencing definite diabetic ketoacidosis (DKA) was higher with dapagliflozin 5 mg (4.0%) and 10 mg (3.5%) compared with placebo (1.1%) over 52 weeks; most events were of mild or moderate severity, and all resolved with treatment.
CONCLUSIONS
Over 52 weeks, dapagliflozin provided glycaemic and weight benefits, with no increased frequency of severe hypoglycaemia compared with placebo. More DKA events were reported with dapagliflozin than placebo, highlighting the importance of appropriate patient selection, education and risk mitigation strategies. This article is protected by copyright. All rights reserved.",2020,"At Week 24, reductions were seen with dapagliflozin 5 and 10 mg compared with placebo in HbA1c (-0.40%, -0.43% vs 0.00%) and body weight (-2.45,","['Adults with T1D and HbA1c 7.5-10.5', 'DEPICT-1 and -2', 'patients with type 1 diabetes (T1D', 'Patients with Inadequately Controlled Type 1 Diabetes']","['dapagliflozin therapy', 'placebo', 'dapagliflozin 5, 10\u2009mg or placebo', 'Dapagliflozin', 'dapagliflozin']","['glycaemic and weight benefits', 'efficacy and safety', 'proportion of patients experiencing definite diabetic ketoacidosis (DKA', 'severe hypoglycaemic events', 'body weight', 'HbA1c and body weight reductions', 'frequency of severe hypoglycaemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}]",,0.189899,"At Week 24, reductions were seen with dapagliflozin 5 and 10 mg compared with placebo in HbA1c (-0.40%, -0.43% vs 0.00%) and body weight (-2.45,","[{'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""Institute for Endocrinology and Diabetes, Schneider Children's Medical Center of Israel, Tel-Aviv University, Tel-Aviv, Israel.""}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Clinical and Experimental Endocrinology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Araki', 'Affiliation': 'Department of Metabolic Medicine, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'di Bartolo', 'Affiliation': 'Ravenna Internal Medicine Department, Ravenna Diabetes Clinic, Romagna Local Health Authority, Ravenna, Italy.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bergenstal', 'Affiliation': 'International Diabetes Center, Health Partners Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Heller', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield School of Medicine, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hansen', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Markus Florian', 'Initials': 'MF', 'LastName': 'Scheerer', 'Affiliation': 'BioPharmaceuticals Medical, AstraZeneca, Wedel, Germany.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Thoren', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Arya', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Paresh', 'Initials': 'P', 'LastName': 'Dandona', 'Affiliation': 'Department of Endocrinology, Kaleida Health, Buffalo, New York, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.14248']
1864,33145946,"Intraoperative ipsilateral subclavian port catheter implantation in resectable breast cancer patients: A novel, safe, and convenient clinical practice.","BACKGROUND
Port catheter (PC) is a classical route of administering chemotherapy for breast cancer patients. We established a standard operating procedure (SOP) of intraoperative ipsilateral subclavian PC implantation in selected resectable breast cancer patients.
METHODS
We conducted a prospective clinical study to assess its safety and complications. A total of seventy six resectable breast cancer patients were included for intraoperative ipsilateral subclavian PC implantation. Thirty patients receiving conventional percutaneous contralateral PC implantation under local anesthesia at the same period were recruited as control group. The time consuming of implantation, and PC-related complications were recorded. Visual analog scale questionnaires were used to assess patients' satisfaction.
RESULTS
Compared with conventional contralateral PC implantation under local anesthesia, SOP for intraoperative ipsilateral subclavian PC implantation significantly shortens the time consuming (11.6 vs. 28.6 min, p < 0.001). With a median retention time of 6.3 months, the overall incidence rate of PC-related complications is 21%, of which the most common complications are infections and venous thromboembolism (7.9% for each). Most patients (86.8%) with intraoperative ipsilateral subclavian PC implantation have completed the whole chemotherapy successfully. Due to the general anesthesia and shorter time consuming, intraoperative implantation gains significantly more patients' satisfaction.
CONCLUSIONS
In the present study, we develop a SOP for intraoperative ipsilateral subclavian PC implantation in resectable breast cancer patients, which is noval, convenient, and safe. In selected breast cancer patients with indications for adjuvant chemotherapy, this practice could significantly shorten the time consuming of PC implantation and improve the degree of patients' satisfaction.",2020,"With a median retention time of 6.3 months, the overall incidence rate of PC-related complications is 21%, of which the most common complications are infections and venous thromboembolism (7.9% for each).","['selected breast cancer patients with indications for adjuvant chemotherapy', 'selected resectable breast cancer patients', 'resectable breast cancer patients', 'Thirty patients receiving conventional percutaneous contralateral PC implantation under local anesthesia at the same period were recruited as control group', 'seventy six resectable breast cancer patients', 'breast cancer patients']","['intraoperative ipsilateral subclavian PC implantation', 'standard operating procedure (SOP) of intraoperative ipsilateral subclavian PC implantation', 'conventional contralateral PC implantation', 'Port catheter (PC', 'Intraoperative ipsilateral subclavian port catheter implantation']","['safety and complications', 'time consuming of implantation, and PC-related complications', 'overall incidence rate of PC-related complications', 'infections and venous thromboembolism', 'Visual analog scale questionnaires']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C3494350', 'cui_str': 'Port Catheters'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319622', 'cui_str': '76'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0589488', 'cui_str': 'Subclavicular approach'}, {'cui': 'C3494350', 'cui_str': 'Port Catheters'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C3494350', 'cui_str': 'Port Catheters'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",76.0,0.079204,"With a median retention time of 6.3 months, the overall incidence rate of PC-related complications is 21%, of which the most common complications are infections and venous thromboembolism (7.9% for each).","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Department of Breast Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yubo', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Ultrasound, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Department of Breast Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Breast Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Breast Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Breast Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.'}]",Cancer medicine,['10.1002/cam4.3595']
1865,33146110,"A Cluster Randomized Trial of the Impact of Education through Listening (a Novel Behavior Change Technique) on Household Water Treatment with Chlorine in Vihiga District, Kenya, 2010-2011.","Despite multiple studies demonstrating the effectiveness of household water treatment with chlorine in disinfecting water and preventing diarrhea, social marketing of this intervention in low- and middle-income countries has resulted in only modest uptake. In a cluster randomized trial in Vihiga district, western Kenya, we compared uptake of household water treatment with chlorine among six villages served by community vendors trained in standard social marketing plus education through listening (ETL), an innovative behavior change method, and six villages served by community vendors trained in standard social marketing only. Water treatment uptake, water quality, and childhood diarrhea were measured over 6 months and compared between the two groups of villages. During the 6-month period, we found no association between ETL exposure and reported and confirmed household water treatment with chlorine. In both groups (ETL and comparison), reported use of water treatment was low and did not change during our 6-month follow-up. However, persons confirmed to have chlorinated water had improved bacteriologic water quality. Study findings suggest that ETL implementation was suboptimal, which, along with unexpected changes in the supply and price of chlorine, may have prevented an accurate assessment of the potential impact of ETL on water treatment behavior. Taken together, these observations exemplify the complexities of habits, practices, attitudes, and external factors that can create challenging conditions for implementing behavioral interventions. As a consequence, in this trial, ETL had no measurable impact on water treatment behavior.",2020,"Water treatment uptake, water quality, and childhood diarrhea were measured over 6 months and compared between the two groups of villages.","['Household Water Treatment with Chlorine in Vihiga District, Kenya, 2010-2011']","['community vendors trained in standard social marketing plus education through listening (ETL), an innovative behavior change method, and six villages served by community vendors trained in standard social marketing only', 'Education through Listening (a Novel Behavior Change Technique']","['Water treatment uptake, water quality, and childhood diarrhea', 'bacteriologic water quality']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0008209', 'cui_str': 'Chlorine'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042462', 'cui_str': 'Vendors'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037424', 'cui_str': 'Social Marketing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0597680', 'cui_str': 'Water Quality'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205465', 'cui_str': 'Bacteriologic'}]",,0.0364843,"Water treatment uptake, water quality, and childhood diarrhea were measured over 6 months and compared between the two groups of villages.","[{'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Stauber', 'Affiliation': 'Department of Population Health Sciences, School of Public Health, Atlanta, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Bobbie', 'Initials': 'B', 'LastName': 'Person', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Otieno', 'Affiliation': 'Safe Water and AIDS Project, Kisumu, Kenya.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Oremo', 'Affiliation': 'Safe Water and AIDS Project, Kisumu, Kenya.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Schilling', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hayat', 'Affiliation': 'Department of Population Health Sciences, School of Public Health, Atlanta, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Ayers', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Quick', 'Affiliation': 'Division of Foodborne, Waterborne, and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0215']
1866,33146324,Effect of implementation intention on walking in people with diabetes: an experimental approach.,"OBJECTIVE
To evaluate the effect of implementation intentions as an intervention strategy to promote walking in adults with type 2 diabetes mellitus (T2DM).
METHODS
We conducted a controlled and randomized trial, with 12 months of follow-up, involving 65 people with T2DM recruited from primary health care units and allocated them in the control group (CG, n = 32) and intervention group (IG, n = 33). The IG received the implementation intention strategy to promote walking and the CG remained in follow-up for conventional treatment in primary health care. The researchers were blinded by anthropometric measurements and the filling of the instruments.
RESULTS
After twelve months of follow up, the IG presented a statistically significant increase in the leisure time physical activity when compared with the CG (p = 0.0413) and showed a significant decrease in waist circumference (p = 0.0061). No significant difference was observed regarding body mass index and glycated hemoglobin among groups.
CONCLUSIONS
Implementation intention was effective in promoting walking and improving clinical indicators in adults with T2DM.",2020,"After twelve months of follow up, the IG presented a statistically significant increase in the leisure time physical activity when compared with the CG (p = 0.0413) and showed a significant decrease in waist circumference (p = 0.0061).","['65 people with T2DM recruited from primary health care units and allocated them in the control group (CG, n = 32) and intervention group (IG, n = 33', 'adults with T2DM', 'adults with type 2 diabetes mellitus (T2DM', 'people with diabetes']","['implementation intention', 'implementation intentions']","['waist circumference', 'body mass index and glycated hemoglobin', 'leisure time physical activity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",65.0,0.078338,"After twelve months of follow up, the IG presented a statistically significant increase in the leisure time physical activity when compared with the CG (p = 0.0413) and showed a significant decrease in waist circumference (p = 0.0061).","[{'ForeName': 'Marco Antonio Vieira da', 'Initials': 'MAVD', 'LastName': 'Silva', 'Affiliation': 'Universidade Estadual de Campinas. Faculdade de Odontologia de Piracicaba. Piracicaba, SP, Brasil.'}, {'ForeName': 'Thaís Moreira', 'Initials': 'TM', 'LastName': 'São-João', 'Affiliation': 'Universidade Estadual de Campinas. Faculdade de Enfermagem. Campinas, SP, Brasil.'}, {'ForeName': 'Marilia Estevam', 'Initials': 'ME', 'LastName': 'Cornelio', 'Affiliation': 'Universidade Estadual de Campinas. Faculdade de Enfermagem. Campinas, SP, Brasil.'}, {'ForeName': 'Fábio Luiz', 'Initials': 'FL', 'LastName': 'Mialhe', 'Affiliation': 'Universidade Estadual de Campinas. Faculdade de Odontologia de Piracicaba. Piracicaba, SP, Brasil.'}]",Revista de saude publica,['10.11606/s1518-8787.2020054002024']
1867,33146345,Cannabidiol for the treatment of crack-cocaine craving: an exploratory double-blind study.,"OBJECTIVE
To assess the efficacy of cannabidiol (CBD) in the management of crack-cocaine craving and the treatment of frequent withdrawal symptoms.
METHODS
Thirty-one men with a diagnosis of crack-cocaine dependence were enrolled in a randomized, double-blind, placebo-controlled trial. We applied neuropsychological tests and assessed craving intensity, anxiety and depression symptoms, and substance use patterns at baseline and at the end of the trial. The participants were treated with CBD 300 mg/day or placebo for 10 days. During this period, we used a technique to induce craving and assessed the intensity of symptoms before and after the induction procedure.
RESULTS
Craving levels reduced significantly over the 10 days of the trial, although no differences were found between the CBD and placebo groups. Craving induction was successful in both groups, with no significant differences between them. Indicators of anxiety, depression, and sleep alterations before and after treatment also did not differ across groups.
CONCLUSION
Under the conditions of this trial, CBD was unable to interfere with symptoms of crack-cocaine withdrawal. Further studies with larger outpatient samples involving different doses and treatment periods would be desirable and timely to elucidate the potential of CBD to induce reductions in crack-cocaine self-administration.",2020,"RESULTS
Craving levels reduced significantly over the 10 days of the trial, although no differences were found between the CBD and placebo groups.","['Thirty-one men with a diagnosis of crack-cocaine dependence', 'crack-cocaine craving']","['CBD 300 mg/day or placebo', 'placebo', 'cannabidiol (CBD']","['Indicators of anxiety, depression, and sleep alterations', 'craving intensity, anxiety and depression symptoms, and substance use patterns', 'Craving induction', 'Craving levels']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085163', 'cui_str': 'Cocaine freebase'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",31.0,0.184789,"RESULTS
Craving levels reduced significantly over the 10 days of the trial, although no differences were found between the CBD and placebo groups.","[{'ForeName': 'Carolina de', 'Initials': 'C', 'LastName': 'Meneses-Gaya', 'Affiliation': 'Laboratório Interdisciplinar de Neurociências Clínicas (LiNC), Departamento de Psiquiatria, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Crippa', 'Affiliation': 'Divisão de Psiquiatria, Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo (FMRP-USP), Ribeirão Preto, São Paulo, SP, Brazil.'}, {'ForeName': 'Jaime E', 'Initials': 'JE', 'LastName': 'Hallak', 'Affiliation': 'Divisão de Psiquiatria, Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo (FMRP-USP), Ribeirão Preto, São Paulo, SP, Brazil.'}, {'ForeName': 'André Q', 'Initials': 'AQ', 'LastName': 'Miguel', 'Affiliation': 'Departamento de Psiquiatria, Instituto Nacional de Políticas Públicas do Álcool e Drogas (INPAD), UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Ronaldo', 'Initials': 'R', 'LastName': 'Laranjeira', 'Affiliation': 'Departamento de Psiquiatria, Instituto Nacional de Políticas Públicas do Álcool e Drogas (INPAD), UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Rodrigo A', 'Initials': 'RA', 'LastName': 'Bressan', 'Affiliation': 'Laboratório Interdisciplinar de Neurociências Clínicas (LiNC), Departamento de Psiquiatria, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Antonio W', 'Initials': 'AW', 'LastName': 'Zuardi', 'Affiliation': 'Divisão de Psiquiatria, Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo (FMRP-USP), Ribeirão Preto, São Paulo, SP, Brazil.'}, {'ForeName': 'Acioly L', 'Initials': 'AL', 'LastName': 'Lacerda', 'Affiliation': 'Laboratório Interdisciplinar de Neurociências Clínicas (LiNC), Departamento de Psiquiatria, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2020-1416']
1868,33141790,An intervention to change illness representations and self-care of individuals with Type 2 Diabetes: A randomized controlled trial.,"OBJECTIVE
METHODS: A two-arm randomised controlled trial (RCT) was used. A total of 455 T2DM patients were recruited from an outpatient DM clinic and randomized to an intervention group that consisted of five weekly group-based education sessions, or a control group that received five weekly educational booklets. Evaluation was conducted at baseline, and one-month and six-month follow-up.
RESULTS
The 2 x 3 linear mixed model analysis using modified intention-to-treat revealed a significant time x condition interaction effect on level of self-care, F(2, 840)=7.78, p<.001, self-care self-efficacy, F(1.89, 794.57)=14.40, p<.001, and use of adaptive coping strategies, F(1.94, 812.93)=4.75, p=.010, in which participants in the intervention group reported greater improvement in such aspects compared to those in the control group. A significant time effect was observed in some dimensions of illness representations. No significant effect was found in glycated haemoglobin. Participants reported positive feedback to the intervention and perceived improvement in various domains.
CONCLUSIONS
The CSM-based intervention was effective in improving self-care and coping among DM patients. The intervention also demonstrated high feasibility and acceptability. Findings provided important insights in improving health-related outcomes for patients with T2DM using the CSM framework.",2020,No significant effect was found in glycated haemoglobin.,"['patients with T2DM using the CSM framework', 'individuals with Type 2 Diabetes', '455 T2DM patients were recruited from an outpatient DM clinic and randomized to an']","['intervention group that consisted of five weekly group-based education sessions, or a control group that received five weekly educational booklets']","['positive feedback', 'glycated haemoglobin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4521841', 'cui_str': 'US Military enlisted E9'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",455.0,0.118912,No significant effect was found in glycated haemoglobin.,"[{'ForeName': 'Virginia W Y', 'Initials': 'VWY', 'LastName': 'Chan', 'Affiliation': 'Centre for Health Behaviours Research, School of Public Health and Primary Care, the Chinese University of Hong Kong.'}, {'ForeName': 'Alice P S', 'Initials': 'APS', 'LastName': 'Kong', 'Affiliation': 'Department of Medicine and Therapeutics, the Chinese University of Hong Kong.'}, {'ForeName': 'Joseph T F', 'Initials': 'JTF', 'LastName': 'Lau', 'Affiliation': 'Centre for Health Behaviours Research, School of Public Health and Primary Care, the Chinese University of Hong Kong.'}, {'ForeName': 'Winnie W S', 'Initials': 'WWS', 'LastName': 'Mak', 'Affiliation': 'Department of Psychology, the Chinese University of Hong Kong.'}, {'ForeName': 'Linda D', 'Initials': 'LD', 'LastName': 'Cameron', 'Affiliation': 'Department of Psychological Sciences, University of California Merced.'}, {'ForeName': 'Phoenix K H', 'Initials': 'PKH', 'LastName': 'Mo', 'Affiliation': 'Centre for Health Behaviours Research, School of Public Health and Primary Care, the Chinese University of Hong Kong.'}]",Psychosomatic medicine,['10.1097/PSY.0000000000000883']
1869,33141791,Somatosensory illusions elicited by sham electromagnetic field exposure: experimental evidence for a predictive processing account of somatic symptom perception.,"OBJECTIVE
According to the predictive processing theory of somatic symptom generation, body sensations are determined by somatosensory input and central nervous predictions about this input. We examined how expectations shape predictions and consequently bodily perceptions in a task eliciting illusory sensations as laboratory analogue of medically unexplained symptoms.
METHODS
Using the framework of signal detection theory, the influence of sham Wi-Fi on (i) response bias (c) and (ii) somatosensory sensitivity (d') for tactile stimuli was examined using the somatic signal detection task (SSDT). A healthy student sample (n = 83) completed the SSDT twice (sham Wi-Fi on/off) in a randomized order after watching a film that promoted adverse health effects of electromagnetic fields (EMF).
RESULTS
When expecting a Wi-Fi signal to be present, participants showed a significantly more liberal response bias c (p = .010, ηp = .08) for tactile stimuli in the SSDT as evidence of a higher propensity to experience somatosensory illusions. No significant alteration of somatosensory sensitivity d' (p = .76, ηp < .002) was observed.
CONCLUSIONS
Negative expectations about the harmfulness of EMF may foster the occurrence of illusory symptom perceptions via alterations in the somatosensory decision criterion. The findings are in line with central tenets of the predictive processing account of somatic symptom generation. This account proposes a decoupling of percept and somatosensory input so that perception becomes increasingly dependent on predictions. This biased perception is regarded as a risk factor for somatic symptom disorders.",2020,"No significant alteration of somatosensory sensitivity d' (p = .76, ηp < .002) was observed.
",['A healthy student sample (n = 83) completed the'],"['SSDT twice (sham Wi-Fi', 'electromagnetic fields (EMF', ""sham Wi-Fi on (i) response bias (c) and (ii) somatosensory sensitivity (d') for tactile stimuli was examined using the somatic signal detection task (SSDT""]","['tactile stimuli', 'liberal response bias', 'somatosensory sensitivity d']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",83.0,0.041736,"No significant alteration of somatosensory sensitivity d' (p = .76, ηp < .002) was observed.
","[{'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Wolters', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, University of Cologne.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Harzem', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, University of Cologne.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Witthöft', 'Affiliation': 'Institute of Clinical Psychology, Psychotherapy, and Experimental Psychopathology, Johannes Gutenberg University Mainz.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Gerlach', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, University of Cologne.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pohl', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, University of Cologne.'}]",Psychosomatic medicine,['10.1097/PSY.0000000000000884']
1870,33141825,Chest computed tomography outcomes in a randomized clinical trial in cystic fibrosis: Lessons learned from the first ataluren phase 3 study.,"A phase 3 randomized double blind controlled, trial in 238 people with cystic fibrosis (CF) and at least one nonsense mutation (nmCF) investigated the effect of ataluren on FEV1. The study was of 48 weeks duration and failed to meet its primary endpoint. Unexpectedly, while FEV1 declined, chest computed tomography (CT) scores using the Brody-II score as secondary outcome measures did not show progression in the placebo group. Based on this observation it was concluded that the role of CT scans in CF randomized clinical trials was limited. However, more sensitive scoring systems were developed over the last decade warranting a reanalysis of this unique dataset. The aim of our study was to reanalyse all chest CT scans, obtained in the ataluren phase 3 study, using 2 independent scoring systems to characterize structural lung disease in this cohort and to compare progression of structural lung disease over the 48 weeks between treatment arms. 391 study CT scans from 210 patients were reanalysed in random order by 2 independent observers using the CF-CT and Perth-Rotterdam Annotated Grid Morphometric Analysis for CF (PRAGMA-CF) scoring systems. CF-CT and PRAGMA-CF subscores were expressed as %maximal score and %total lung volume, respectively. PRAGMA-CF subscores %Disease (p = 0.008) and %Mucus Plugging (p = 0.029) progressed over 48 weeks. CF-CT subscores did not show progression. There was no difference in progression of structural lung disease between treatment arm and placebo independent of tobramycin use. PRAGMA-CF Chest CT scores can be used as an outcome measure to study the effect of potential disease modifying drugs in CF on lung structure.",2020,PRAGMA-CF subscores %Disease (p = 0.008) and %Mucus Plugging (p = 0.029) progressed over 48 weeks.,"['238 people with cystic fibrosis (CF) and at least one nonsense mutation (nmCF) investigated the effect of ataluren on FEV1', 'cystic fibrosis']","['placebo', 'tobramycin']","['CF-CT and PRAGMA-CF subscores', 'FEV1 declined, chest computed tomography (CT) scores', 'CF-CT subscores', 'progression of structural lung disease']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0544885', 'cui_str': 'Nonsense mutation'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C2930764', 'cui_str': 'ataluren'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}]","[{'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}]",238.0,0.159678,PRAGMA-CF subscores %Disease (p = 0.008) and %Mucus Plugging (p = 0.029) progressed over 48 weeks.,"[{'ForeName': 'Harm A W M', 'Initials': 'HAWM', 'LastName': 'Tiddens', 'Affiliation': ""Department of Pediatric Pulmonology and Allergology, Erasmus Medical Center Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Eleni-Rosalina', 'Initials': 'ER', 'LastName': 'Andrinopoulou', 'Affiliation': 'Department of Biostatistics, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'McIntosh', 'Affiliation': 'Aruvant Biotech, New York, NY, United States of America.'}, {'ForeName': 'J Stuart', 'Initials': 'JS', 'LastName': 'Elborn', 'Affiliation': ""Centre for Experimental Medicine, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Kerem', 'Affiliation': 'Department of Pediatrics and CF Center, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Nynke', 'Initials': 'N', 'LastName': 'Bouma', 'Affiliation': ""Department of Pediatric Pulmonology and Allergology, Erasmus Medical Center Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'Bosch', 'Affiliation': ""Department of Pediatric Pulmonology and Allergology, Erasmus Medical Center Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Mariette', 'Initials': 'M', 'LastName': 'Kemner-van de Corput', 'Affiliation': ""Department of Pediatric Pulmonology and Allergology, Erasmus Medical Center Sophia Children's Hospital, Rotterdam, The Netherlands.""}]",PloS one,['10.1371/journal.pone.0240898']
1871,33142037,"Assessment of target engagement in a first-in-human trial with sinbaglustat, an iminosugar to treat lysosomal storage disorders.","In this first-in-human study the tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple oral doses of sinbaglustat, a dual inhibitor of glucosylceramide synthase (GCS) and non-lysosomal glucosyl ceramidase (GBA2), were investigated in healthy subjects. The single- and multiple-ascending dose (SAD and MAD) studies were randomized, double-blind, and placebo-controlled. Single doses from 10 to 2000 mg in males and multiple doses from 30 to 1000 mg twice daily for 7 days in males and females were investigated. Tolerability, PK, and PD data were collected up to 3 days after (last) treatment administration and analyzed descriptively. Sinbaglustat was well tolerated in the SAD and MAD studies, however, at the highest dose of the MAD, 3 of the 4 female subjects presented a similar pattern of general symptoms. In all cohorts, sinbaglustat was rapidly absorbed. Thereafter, plasma concentrations decreased biphasically. In the MAD, steady-state conditions were reached on Day 2 without accumulation. During sinbaglustat treatment, plasma concentrations of glucosylceramide [GlcCer], lactosylceramide, and globotriaosylceramide decreased in a dose-dependent manner, reflecting GCS inhibition. The more complex the glycosphingolipid, the more time was required to elicit PD changes. After treatment stop, GlcCer levels returned to baseline and increased above baseline at lowest doses, probably due to the higher potency of sinbaglustat on GBA2 compared to GCS. Overall, sinbaglustat was well tolerated up to the highest tested doses. The PK profile is compatible with b.i.d. dosing. Sinbaglustat demonstrated target engagement in the periphery for GCS and GBA2.",2020,"During sinbaglustat treatment, plasma concentrations of glucosylceramide [GlcCer], lactosylceramide, and globotriaosylceramide decreased in a dose-dependent manner, reflecting GCS inhibition.",['healthy subjects'],"['glucosylceramide synthase (GCS) and non-lysosomal glucosyl ceramidase (GBA2', 'placebo']","['GlcCer levels', 'plasma concentrations', 'tolerability, pharmacokinetics (PK), and pharmacodynamics (PD', 'Tolerability, PK, and PD data', 'plasma concentrations of glucosylceramide [GlcCer], lactosylceramide, and globotriaosylceramide decreased in a dose-dependent manner, reflecting GCS inhibition']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0163410', 'cui_str': 'Ceramide glucosyltransferase'}, {'cui': 'C0017768', 'cui_str': 'Beta-glucocerebrosidase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017770', 'cui_str': 'Glucocerebroside'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0022954', 'cui_str': 'Lactosyl Ceramides'}, {'cui': 'C0061338', 'cui_str': 'globotriaosylceramide'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0163410', 'cui_str': 'Ceramide glucosyltransferase'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",,0.0817254,"During sinbaglustat treatment, plasma concentrations of glucosylceramide [GlcCer], lactosylceramide, and globotriaosylceramide decreased in a dose-dependent manner, reflecting GCS inhibition.","[{'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Gehin', 'Affiliation': 'Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Meggane', 'Initials': 'M', 'LastName': 'Melchior', 'Affiliation': 'Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Richard W D', 'Initials': 'RWD', 'LastName': 'Welford', 'Affiliation': 'Drug Discovery Translational Biomarkers, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Patricia N', 'Initials': 'PN', 'LastName': 'Sidharta', 'Affiliation': 'Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",Clinical and translational science,['10.1111/cts.12911']
1872,33142129,"Comparing stigmatizing attitudes toward anorexia nervosa, binge-eating disorder, avoidant-restrictive food intake disorder, and subthreshold eating behaviors in college students.","OBJECTIVE
The relative stigmatization of various eating disorders (ED) remains understudied, and there is no research examining stigma toward avoidant-restrictive food intake disorder (ARFID) or adult picky eating. The present study examined the relative stigmatization of various EDs and the subthreshold eating behaviors that are risk factors for their development, and the relation of gender differences to stigma.
METHOD
A sample of 1147 college students was recruited and completed the study online. Participants were randomized and presented with a vignette representing a clinical ED [anorexia nervosa (AN), binge-eating disorder (BED), ARFID] or a subthreshold eating presentation (restrained eating, emotional eating, picky eating). Participants completed measures of stigma and perceived psychopathology. A 6 (target eating behavior) × 2 (target gender) × 2 (participant gender) MANOVA and subsequent ANOVAs were employed.
RESULTS
Measures of stigma revealed significant main effects for eating presentation and participant gender. There were also significant interactions between eating presentation and participant gender. Men reported more stigmatizing views toward BED and AN compared to women. Overall, restraint was stigmatized less than the other targets, and AN received the greatest amount of stigma. Participants rated BED and AN as more pathological than all other targets, emotional eating and ARFID as more pathological than picky eating and restrained eating, and restrained eating as less pathological than all other targets.
CONCLUSIONS
Future research should explore how the severity of eating behavior influences perceptions and at what level behaviors such as restriction are recognized as disordered.",2020,"Overall, restraint was stigmatized less than the other targets, and AN received the greatest amount of stigma.","['college students', 'Participants were randomized and presented with a vignette representing a clinical ED [anorexia nervosa (AN), binge-eating disorder (BED), ARFID] or a subthreshold eating presentation (restrained eating, emotional eating, picky eating', '1147 college students']",[],['stigma and perceived psychopathology'],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C3840121', 'cui_str': 'Avoidant restrictive food intake disorder'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",1147.0,0.0365584,"Overall, restraint was stigmatized less than the other targets, and AN received the greatest amount of stigma.","[{'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Ellis', 'Affiliation': 'Department of Psychology, East Carolina University, United States of America; Wilford Hall Ambulatory Medical Center, Joint Base San Antonio - Lackland, United States of America. Electronic address: jordanellisphd@gmail.com.'}, {'ForeName': 'Jamal H', 'Initials': 'JH', 'LastName': 'Essayli', 'Affiliation': 'Department of Pediatrics and Psychiatry & Behavioral Health, Penn State College of Medicine, United States of America.'}, {'ForeName': 'Hana F', 'Initials': 'HF', 'LastName': 'Zickgraf', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Rossi', 'Affiliation': 'Department of Psychology, East Carolina University, United States of America.'}, {'ForeName': 'Reid', 'Initials': 'R', 'LastName': 'Hlavka', 'Affiliation': 'Department of Psychology, East Carolina University, United States of America.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Carels', 'Affiliation': 'Department of Psychology, East Carolina University, United States of America.'}, {'ForeName': 'Matt C', 'Initials': 'MC', 'LastName': 'Whited', 'Affiliation': 'Department of Psychology, East Carolina University, United States of America.'}]",Eating behaviors,['10.1016/j.eatbeh.2020.101443']
1873,33142167,"Comparison of intravenous ibuprofen and paracetamol efficiency in soft tissue injuries: A randomized, double-blind study.",,2020,,['soft tissue injuries'],['ibuprofen'],[],"[{'cui': 'C0037578', 'cui_str': 'Soft tissue injury'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]",[],,0.347795,,"[{'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Yalçınlı', 'Affiliation': 'Department of Emergency Medicine, Ege University, 35100 Izmir, Turkey. Electronic address: sercan.yalcinli@ege.edu.tr.'}, {'ForeName': 'Güçlü Selahattin', 'Initials': 'GS', 'LastName': 'Kıyan', 'Affiliation': 'Department of Emergency Medicine, Ege University, 35100 Izmir, Turkey.'}, {'ForeName': 'Özge', 'Initials': 'Ö', 'LastName': 'Can', 'Affiliation': 'Department of Emergency Medicine, Ege University, 35100 Izmir, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.06.063']
1874,33142168,Measuring the physiological impact of extreme heat on lifeguards during cardiopulmonary resuscitation. Randomized simulation study.,"OBJECTIVE
Lifeguard teams carry out their work in extremely hot conditions in many parts of the world. The aim of this study was to analyze the impact of high temperatures on physiological parameters during cardiopulmonary resuscitation (CPR).
METHOD
A randomized quasi-experimental cross-over design was used to test physiological lifesaving demands (50 min acclimatization +10 min CPR) in two different thermal environments: Thermo-neutral environment (25 °C) vs Hyperthermic environment (37 °C).
RESULTS
The data obtained from 21 lifeguards were included, this covers a total of 420 min of resuscitation. The CPR performance was constantly maintained during the 10 min. The Oxygen uptake (VO 2) ranged from 17 to 18 ml/min/kg for chest compressions (CC) and between 13 and 14 ml/min/kg for ventilations (V) at both 25 °C and 37 °C, with no significant difference between environments (p > 0.05). The percentage of maximum heart rate (%HR max) increased between 7% and 8% at 37 °C (p < 0.001), ranging between 75% and 82% of HR max. The loss of body fluids (LBF) was higher in the hyperthermic environment; LBF: (37 °C: 400 ± 187 g vs 25 °C: 148 ± 81 g, p < 0.001). Body temperature was 1 °C higher at the end of the test (p < 0.001). The perceived fatigue (RPE) increased by 37° an average of 2 points on a scale of 10 (p = 0.001).
CONCLUSIONS
Extreme heat is not a limiting factor in CPR performance with two lifeguards. Metabolic consumption is sustained, with an increase in CC, so V can serve as active rest. Nevertheless, resuscitation at 37 °C results in a higher HR, is more exhausting and causes significant loss of fluids due to sweating.",2020,"The perceived fatigue (RPE) increased by 37° an average of 2 points on a scale of 10 (p = 0.001).
",['187\xa0g vs 25'],"['neutral environment (25\xa0°C) vs Hyperthermic environment', 'hyperthermic environment; LBF']","['CPR performance', 'Body temperature', 'percentage of maximum heart rate (%HR max', 'Oxygen uptake', 'perceived fatigue (RPE', 'loss of body fluids (LBF']","[{'cui': 'C4517618', 'cui_str': '187'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]",,0.0691278,"The perceived fatigue (RPE) increased by 37° an average of 2 points on a scale of 10 (p = 0.001).
","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Barcala-Furelos', 'Affiliation': ""Faculty of Education and Sport Sciences, REMOSS Research Group, Universidade de Vigo, Pontevedra, Spain; CLINURSID Research Group, Nursing Department, Universidade de Santiago de Compostela, Santiago de Compostela, Spain; Santiago de Compostela's Health Research Institute (IDIS), Santiago de Compostela, Spain. Electronic address: roberto.barcala@uvigo.es.""}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Fernández-Méndez', 'Affiliation': ""CLINURSID Research Group, Nursing Department, Universidade de Santiago de Compostela, Santiago de Compostela, Spain; Santiago de Compostela's Health Research Institute (IDIS), Santiago de Compostela, Spain; School of Nursing, REMOSS Research Group, Universidade de Vigo, Pontevedra, Spain. Electronic address: mariajosefernandezmendez@gmail.com.""}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Cano-Noguera', 'Affiliation': 'Faculty of Sport, Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'Martín', 'Initials': 'M', 'LastName': 'Otero-Agra', 'Affiliation': 'Faculty of Education and Sport Sciences, REMOSS Research Group, Universidade de Vigo, Pontevedra, Spain. Electronic address: martinoteroagra@gmail.com.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Morán-Navarro', 'Affiliation': 'Faculty of Sport, Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Martínez-Isasi', 'Affiliation': ""CLINURSID Research Group, Nursing Department, Universidade de Santiago de Compostela, Santiago de Compostela, Spain; Santiago de Compostela's Health Research Institute (IDIS), Santiago de Compostela, Spain. Electronic address: smtzisasi@gmail.com.""}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.06.042']
1875,33142248,"Visualization of aggregate perioperative data improves anesthesia case planning: A randomized, cross-over trial.","STUDY OBJECTIVE
A challenge in reducing unwanted care variation is effectively managing the wide variety of performed surgical procedures. While an organization may perform thousands of types of cases, privacy and logistical constraints prevent review of previous cases to learn about prior practices. To bridge this gap, we developed a system for extracting key data from anesthesia records. Our objective was to determine whether usage of the system would improve case planning performance for anesthesia residents.
DESIGN
Randomized, cross-over trial.
SETTING
Vanderbilt University Medical Center.
MEASUREMENTS
We developed a web-based, data visualization tool for reviewing de-identified anesthesia records. First year anesthesia residents were recruited and performed simulated case planning tasks (e.g., selecting an anesthetic type) across six case scenarios using a randomized, cross-over design after a baseline assessment. An algorithm scored case planning performance based on care components selected by residents occurring frequently among prior anesthetics, which was scored on a 0-4 point scale. Linear mixed effects regression quantified the tool effect on the average performance score, adjusting for potential confounders.
MAIN RESULTS
We analyzed 516 survey questionnaires from 19 residents. The mean performance score was 2.55 ± SD 0.32. Utilization of the tool was associated with an average score improvement of 0.120 points (95% CI 0.060 to 0.179; p < 0.001). Additionally, a 0.055 point improvement due to the ""learning effect"" was observed from each assessment to the next (95% CI 0.034 to 0.077; p < 0.001). Assessment score was also significantly associated with specific case scenarios (p < 0.001).
CONCLUSIONS
This study demonstrated the feasibility of developing of a clinical data visualization system that aggregated key anesthetic information and found that the usage of tools modestly improved residents' performance in simulated case planning.",2020,Utilization of the tool was associated with an average score improvement of 0.120 points (95% CI 0.060 to 0.179; p < 0.001).,"['Vanderbilt University Medical Center', '516 survey questionnaires from 19 residents', 'First year anesthesia residents']",[],"['mean performance score', 'learning effect', 'Assessment score']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",,0.0730956,Utilization of the tool was associated with an average score improvement of 0.120 points (95% CI 0.060 to 0.179; p < 0.001).,"[{'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Wanderer', 'Affiliation': 'Department of Anesthesiology, Department of Biomedical Informatics, Vanderbilt University Medical Center, United States. Electronic address: jon.wanderer@vumc.org.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Lasko', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Coco', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Leslie C', 'Initials': 'LC', 'LastName': 'Fowler', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'McEvoy', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Shotwell', 'Affiliation': 'Department of Biostatistics, Department of Anesthesiology, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Gelfand', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Laurie L', 'Initials': 'LL', 'LastName': 'Novak', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Owens', 'Affiliation': 'Owen Graduate School of Management, Vanderbilt University, United States.'}, {'ForeName': 'Daniel V', 'Initials': 'DV', 'LastName': 'Fabbri', 'Affiliation': 'Department of Biomedical Informatics, Department of Computer Science, Vanderbilt University Medical Center, United States.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110114']
1876,33142249,Dose dependent reduction in median effective concentration (EC 50 ) of ropivacaine with adjuvant dexmedetomidine in labor epidural analgesia: An up-down sequential allocation study.,"STUDY OBJECTIVE
Adjuvant dexmedetomidine can be used to reduce the required concentration of ropivacaine for labor epidural analgesia. However, the potency of dexmedetomidine has not been fully studied. The purpose of this study was to determine the median effective concentration (EC 50 ) of ropivacaine with adjuvant dexmedetomidine.
DESIGN
Prospective, double-blind, up-down sequential allocation study.
SETTING
Academic medical center specializing in the care of women and children.
PATIENTS
One hundred and fifty healthy, term parturients requesting labor epidural analgesia were randomly assigned to 1 of 5 different concentrations of dexmedetomidine: 0 μg/ml, 0.3 μg/ml, 0.4 μg/ml, 0.5 μg/ml, or 0.6 μg/ml.
INTERVENTIONS
The study solution for the first patient in each group included the randomly assigned concentration of dexmedetomidine in 0.1% ropivacaine. Subsequent patients in each randomization group received the assigned concentration of dexmedetomidine in a new concentration of ropivacaine as determined by the up-down allocation methodology. Effective analgesia was defined as pain on the visual analogue scale of<3 at30 min after administration of local anesthetic. The up-down sequential allocation method and probit regression were used to calculate the EC 50 of epidural ropivacaine.
MEASUREMENTS
The primary outcome was pain 30 min after administration of local anesthetic via epidural catheter. Exploratory outcomes included side effects, neonatal outcomes, and obstetric outcomes.
MAIN RESULTS
The EC 50 values for ropivacaine in dexmedetomidine 0.4 μg/ml, 0.5 μg/ml, and 0.6 μg/ml (0.044% [95% CI 0.036% to 0.045%], 0.035% [95% CI 0.031% to 0.041%], and 0.039% [95% CI 0.034% to 0.045%], respectively) were lower compared to ropivacaine in dexmedetomidine 0 μg/ml and 0.3 μg/ml (0.086% [95% CI 0.081% to 0.092%], and, 0.069% [95% CI 0.056% to 0.076%], respectively). Differences between EC 50 values for ropivacaine in dexmedetomidine 0.4 μg/ml, 0.5 μg/ml, and 0.6 μg/ml were not statistically significant. Results of our exploratory analyses did not reveal differences in side effects, neonatal outcomes, or obstetric outcomes.
CONCLUSIONS
In this study, the lowest concentration of dexmedetomidine in ropivacaine with the greatest clinical effect was 0.4 μg/ml, which is important because there may be no additional analgesic benefit of dexmedetomidine greater than 0.4 μg/ml.",2020,Adjuvant dexmedetomidine can be used to reduce the required concentration of ropivacaine for labor epidural analgesia.,"['Academic medical center specializing in the care of women and children', 'One hundred and fifty healthy, term parturients requesting labor epidural analgesia', 'labor epidural analgesia']","['dexmedetomidine: 0\xa0μg/ml, 0.3\xa0μg/ml', 'ropivacaine', 'dexmedetomidine']","['side effects, neonatal outcomes, or obstetric outcomes', 'median effective concentration', 'pain 30\xa0min after administration of local anesthetic via epidural catheter', 'side effects, neonatal outcomes, and obstetric outcomes']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}]",150.0,0.494868,Adjuvant dexmedetomidine can be used to reduce the required concentration of ropivacaine for labor epidural analgesia.,"[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing Maternity and Child Care Hospital, Jiaxing City, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Drzymalski', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Wenping', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing Maternity and Child Care Hospital, Jiaxing City, China.'}, {'ForeName': 'Wangping', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing Maternity and Child Care Hospital, Jiaxing City, China.'}, {'ForeName': 'Lizhong', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing Maternity and Child Care Hospital, Jiaxing City, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing Maternity and Child Care Hospital, Jiaxing City, China. Electronic address: 13706597501@163.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110115']
1877,33143006,A Comparative Study on the Performance Profile of Under-17 and Under-19 Handball Players Trained in the Sports School System.,"This study evaluates the anatomical profiles, jump, sprint, power outputs, endurance, and peak blood lactate levels ([LA] peak ) of handball players of two age groups-U17 ( n = 77) and U19 ( n = 46)-and analyses the role of training in their physical abilities. Vertical jump performance was determined by counter movement jump (CMJ) and counter movement jump with free arms (CMJFA) tests. A running-based anaerobic sprint test (RAST) determined the relative power output (watts/kg body weight) and absolute power output (watts) of the players. Sprint performance over 5 m, 10 m, and 30 m distances was evaluated. An incremental shuttle run test (40 m) was designed to determine aerobic threshold (AeT), anaerobic threshold (AnT), and [LA] peak . All parameters were measured for pivots, wingers, backs, and goalkeepers of each group. The U19 players were significantly heavier than the U17 group, but both the groups were nearly equal in height. The U19 group jumped higher than the U17 members, although the only significant difference ( p = 0.032) was observed between the wingers of the groups in CMJ. Sprint performance varied marginally between the groups and only U19 pivots were found to be significantly (for distances of 5, 10, and 30 m: p = 0.047, p = 0.018, and p = 0.021, respectively) faster than U17 pivots. No difference in relative power output between the groups was noted, although the U19 players recorded higher absolute power outputs. Maximal velocity and velocities at the AeT and AnT were almost similar in the groups. Distance covered by the groups at the intensities of AeT and AnT varied only little. Higher [LA] peak was observed in the U19 players. U19 players failed to convert their superior power into speed and jump. The training pattern of the handball players needs to be revised so that U19 players may develop faster and be more enduring than the U17 group.",2020,Vertical jump performance was determined by counter movement jump (CMJ) and counter movement jump with free arms (CMJFA) tests.,"['handball players of two age groups-U17 ( n = 77) and', 'Under-17 and Under-19 Handball Players Trained in the Sports School System', 'U19 players']",['A running-based anaerobic sprint test (RAST'],"['aerobic threshold (AeT), anaerobic threshold (AnT), and [LA] peak ', 'Higher [LA] peak', 'Maximal velocity and velocities', 'anatomical profiles, jump, sprint, power outputs, endurance, and peak blood lactate levels ([LA] peak ', 'Vertical jump performance', 'relative power output', 'Sprint performance']","[{'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034554', 'cui_str': 'Radioallergosorbent test'}]","[{'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0187414,Vertical jump performance was determined by counter movement jump (CMJ) and counter movement jump with free arms (CMJFA) tests.,"[{'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Gabrys', 'Affiliation': 'Department of Physical Education and Sport Science, Faculty of Pedagogy, University of West Bohemia, 301 00 Pilsen, Czech Republic.'}, {'ForeName': 'Arkadiusz', 'Initials': 'A', 'LastName': 'Stanula', 'Affiliation': 'Institute of Sport Science, The Jerzy Kukuczka Academy of Physical Education, Mikołowska 72A, 40-065 Katowice, Poland.'}, {'ForeName': 'Subir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Faculty of Medical Sciences, University of West Indies, 11000 Cave Hill, Barbados.'}, {'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Szmatlan-Gabrys', 'Affiliation': 'Faculty of Rehabilitation, Department of Anatomy, University of Physical Education, 31-571 Krakow, Poland.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Benešová', 'Affiliation': 'Department of Physical Education and Sport Science, Faculty of Pedagogy, University of West Bohemia, 301 00 Pilsen, Czech Republic.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Wicha', 'Affiliation': 'Polish Handball Federation, Puławska 300 A, 02-819 Warszawa, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Baron', 'Affiliation': 'Institute of Sport Science, The Jerzy Kukuczka Academy of Physical Education, Mikołowska 72A, 40-065 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17217979']
1878,33143009,Physical Activity and Psychosocial Characteristics of the Peer Supporters in the PLAN-A Study-A Latent Class Analysis.,"PLAN-A is a cluster randomised controlled trial of a peer-led physical activity intervention which uses peer supporters to increase the physical activity of 13-14-year-old girls in the UK. This paper uses latent class analysis to identify classes in the whole study population and investigate how those selected as peer supporters in PLAN-A were drawn from different social groups. We identified five classes of girls, based on psychosocial variables (self-esteem, physical activity self-efficacy, motivation, physical activity values among friends and peer support for physical activity (PA) and physical activity behaviour variables (average minutes of weekday MVPA, sedentary time and screen viewing). Peer supporters were similar to the whole study population in terms of overall demographics, but were drawn unequally from the five classes. In addition, there was considerable variation in the distribution of peer supporters between schools. The selection of peer supporters is an integral component of peer-led interventions and should be explored and linked to underlying theory to understand the characteristics of those recruited. However, demographic representativeness is not necessarily the aim, and simple reporting of overall demographic comparisons may mask important differences within subgroups.",2020,PLAN-A is a cluster randomised controlled trial of a peer-led physical activity intervention which uses peer supporters to increase the physical activity of 13-14-year-old girls in the UK.,['13-14-year-old girls in the UK'],['peer-led physical activity intervention'],"['psychosocial variables (self-esteem, physical activity self-efficacy, motivation, physical activity values among friends and peer support for physical activity (PA) and physical activity behaviour variables (average minutes of weekday MVPA, sedentary time and screen viewing', 'Physical Activity and Psychosocial Characteristics']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",,0.0251401,PLAN-A is a cluster randomised controlled trial of a peer-led physical activity intervention which uses peer supporters to increase the physical activity of 13-14-year-old girls in the UK.,"[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Salway', 'Affiliation': 'Centre for Exercise, Nutrition & Health Sciences, School for Policy Studies, University of Bristol, 8 Priory Road, Bristol BS8 1TZ, UK.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Sebire', 'Affiliation': 'Centre for Exercise, Nutrition & Health Sciences, School for Policy Studies, University of Bristol, 8 Priory Road, Bristol BS8 1TZ, UK.'}, {'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Tibbitts', 'Affiliation': 'Centre for Exercise, Nutrition & Health Sciences, School for Policy Studies, University of Bristol, 8 Priory Road, Bristol BS8 1TZ, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Sanderson', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol BS8 1TZ, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kandiyali', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol BS8 1TZ, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Willis', 'Affiliation': 'Centre for Exercise, Nutrition & Health Sciences, School for Policy Studies, University of Bristol, 8 Priory Road, Bristol BS8 1TZ, UK.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'MacNeill', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol BS8 1TZ, UK.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Jago', 'Affiliation': 'Centre for Exercise, Nutrition & Health Sciences, School for Policy Studies, University of Bristol, 8 Priory Road, Bristol BS8 1TZ, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17217980']
1879,33143064,Getting Active with Active Video Games: A Quasi-Experimental Study.,"Given the cultural emphasis on academic achievement and environmental constraints to physical activity (PA), active video games (AVGs) may be used to decrease sedentary behavior and increase PA of Hong Kong children. This study explored the potential of a school-based AVG intervention on sedentary time, PA, body composition, and psychosocial factors among children. Eighty-seven children (intervention n = 30) were recruited from one primary school. Classes in Grades 4-6 were allocated to either the intervention group or the control group in a 2:1 ratio. The eight-week intervention involved children playing AVGs in an after-school class twice a week. Participants in the control group continued with their usual activities. Outcome included the change of participants in sedentary time, PA, percentage body fat, body mass index (BMI), and psychosocial variables (enjoyment, self-efficacy and social support), from baseline to eight weeks. No significant group differences were observed in sedentary time (-33.9 min/day, 95% CI -70.8 to 4.8; p = 0.07). The intervention group significantly increased total PA (53.7 counts/min, 95% CI 8.6 to 104.2; p = 0.04) compared with those in the control condition. No differences were found in body composition and psychosocial variables. However, significant treatment effects were found on BMI z score among boys (-0.1, 95% CI -0.2 to 0; p = 0.04). An eight-week school-based AVG intervention delivered during after-school hours was effective in increasing activity levels among Hong Kong children. The treatment effects of AVGs on sedentary behavior and body composition need to be further demonstrated in a more robust study, especially in boys.",2020,"The intervention group significantly increased total PA (53.7 counts/min, 95% CI 8.6 to 104.2; p = 0.04) compared with those in the control condition.","['children', 'Eighty-seven children (intervention n = 30) were recruited from one primary school', 'Classes in Grades 4-6']",['school-based AVG intervention'],"['sedentary time', 'total PA', 'activity levels', 'children playing AVGs', 'sedentary time, PA, body composition, and psychosocial factors', 'body composition and psychosocial variables', 'change of participants in sedentary time, PA, percentage body fat, body mass index (BMI), and psychosocial variables (enjoyment, self-efficacy and social support', 'BMI z score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",87.0,0.0127487,"The intervention group significantly increased total PA (53.7 counts/min, 95% CI 8.6 to 104.2; p = 0.04) compared with those in the control condition.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ""Department of Physical Education, China Women's University, Beijing 100101, China.""}, {'ForeName': 'Patrick W C', 'Initials': 'PWC', 'LastName': 'Lau', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, 1010 Auckland, New Zealand.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Maddison', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, VIC 3125, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17217984']
1880,33143121,The Effect of Soluble Fiber Dextrin on Subjective and Physiological Markers of Appetite: A Randomized Trial.,"Obesity is a leading public health problem throughout the world. The development of foods that increase satiety and reduce food may aid weight management. This study determined the effect of consuming soluble fiber dextrin (SFD) on appetite, appetitive hormones, breath hydrogen and food intake in adults. Forty-three participants completed this study. For each treatment, 50% of the SFD was provided in liquid form as part of breakfast and 50% in solid form as a morning snack. Appetite questionnaires, blood and breath samples were collected immediately before breakfast and at regular intervals during the test session. The participants consumed an ad libitum lunch meal, afternoon snack and dinner meal, and the amount eaten was recorded. Following dinner, participants left the laboratory but were required to keep a diet diary for the remainder of the day. Breath hydrogen concentration was significantly higher following the consumption of SFD compared to control ( p < 0.05). There was no observed overall treatment effect of consuming SFD on GLP-1 (Glucagon-Like-Peptide-1), ghrelin, CCK-8 (Cholecystokinin) or PYY 3-36 (Petptide YY) ( p > 0.05). Moreover, consuming foods containing SFD had no effect on subjective appetite or food intake ( p > 0.05). Consuming foods containing SFD increased breath hydrogen but did not influence food intake, appetite or appetitive hormones. However, the limitations of this study may have individually or collectively masked an effect of SFD on food intake and appetite.",2020,There was no observed overall treatment effect of consuming SFD on GLP-1,"['adults', 'Forty-three participants completed this study']","['consuming soluble fiber dextrin (SFD', 'Soluble Fiber Dextrin']","['Appetite questionnaires, blood and breath samples', 'appetite, appetitive hormones, breath hydrogen and food intake', 'Glucagon-Like-Peptide-1), ghrelin, CCK-8 (Cholecystokinin', 'subjective appetite or food intake', 'food intake, appetite or appetitive hormones', 'breath hydrogen', 'GLP-1', 'Subjective and Physiological Markers of Appetite', 'Breath hydrogen concentration']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3661727', 'cui_str': 'Soluble fiber'}, {'cui': 'C0011808', 'cui_str': 'Dextrins'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0037167', 'cui_str': 'Sincalide'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",43.0,0.0769797,There was no observed overall treatment effect of consuming SFD on GLP-1,"[{'ForeName': 'Christine H', 'Initials': 'CH', 'LastName': 'Emilien', 'Affiliation': 'Department of Food Science and Human Nutrition, Iowa State University, Ames, IA 50011, USA.'}, {'ForeName': 'Walter H', 'Initials': 'WH', 'LastName': 'Hsu', 'Affiliation': 'Department of Biomedical Sciences, Iowa State University, Ames, IA 50011, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Hollis', 'Affiliation': 'Department of Food Science and Human Nutrition, Iowa State University, Ames, IA 50011, USA.'}]",Nutrients,['10.3390/nu12113341']
1881,33143214,"The Effect of Robot-Assisted Gait Training on Locomotor Function and Functional Capability for Daily Activities in Children with Cerebral Palsy: A Single-Blinded, Randomized Cross-Over Trial.","PURPOSE
The effectiveness of robot-assisted gait training (RAGT) in children with cerebral palsy (CP), especially in terms of improving the performance of daily activities, remains unclear. Therefore, we aimed to investigate the effectiveness of RAGT in children with CP.
METHODS
In this single-center, single-blinded, randomized cross-over trial, we enrolled 20 children with CP with Gross Motor Function Classification System (GMFCS) levels II-IV (13 males; age range, 6.75 ± 2.15 years). The participants were randomized into the RAGT/standard care (SC) ( n = 10) and SC/RAGT/SC sequence groups ( n = 10). Using a Walkbot-K system, the RAGT program comprised 3 × 30-min sessions/week for 6 weeks with a continued SC program. The SC program comprised 2-4 conventional physiotherapy sessions/week for 6 weeks. The Gross Motor Function Measure-88 (GMFM-88), the pediatric functional independence measure (WeeFIM), and the Canadian occupational performance measure (COPM) scores were assessed pre- and post-RAGT or SC periods and treatment, period, follow-up, and carry-over effects were analyzed. Energy expenditure and body composition were measured pre- and post-RAGT.
RESULTS
Significant treatment effects were observed in dimensions D and E of the GMFM (D: p = 0.018; E: p = 0.021) scores, WeeFIM mobility subtotal ( p = 0.007), and COPM performance ( p < 0.001) and satisfaction ( p = 0.001) measure scores. The period, follow-up, and carry-over effects were not statistically significant. The gross energy cost significantly decreased ( p = 0.041) and the skeletal muscle mass increased ( p = 0.014) at post-RAGT assessment. The factors associated with functional outcomes showed significant improvements in the GMFM D scores and were mainly observed in children with GMFCS levels II-III compared to those classified at level IV ( p = 0.038).
CONCLUSION
RAGT had training benefits for children with CP. Specifically, it improved locomotor function and functional capability for daily activities. These effects were better in ambulatory children with CP. However, as SC interventions continued during the RAGT period, these improvements may be also related to multiple treatment effects.",2020,"RESULTS
Significant treatment effects were observed in dimensions D and E of the GMFM","['children with cerebral palsy (CP', 'ambulatory children with CP', '20 children with CP with Gross Motor Function Classification System (GMFCS) levels II-IV (13 males; age range, 6.75 ± 2.15 years', 'children with CP', 'Children with Cerebral Palsy']","['Robot-Assisted Gait Training', 'RAGT', 'robot-assisted gait training (RAGT', 'RAGT/standard care (SC) ( n = 10) and SC/RAGT/SC sequence']","['gross energy cost', 'COPM performance', 'GMFM D scores', 'Locomotor Function and Functional Capability for Daily Activities', 'skeletal muscle mass', 'locomotor function and functional capability for daily activities', 'Energy expenditure and body composition', 'satisfaction', 'Gross Motor Function Measure-88 (GMFM-88), the pediatric functional independence measure (WeeFIM), and the Canadian occupational performance measure (COPM) scores', 'dimensions D and E of the GMFM', 'scores, WeeFIM mobility subtotal ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441926', 'cui_str': 'Level II'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4708904', 'cui_str': '6.75'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}]","[{'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C2733180', 'cui_str': 'Canadian occupational performance measure score'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}]",20.0,0.0240992,"RESULTS
Significant treatment effects were observed in dimensions D and E of the GMFM","[{'ForeName': 'Li Hua', 'Initials': 'LH', 'LastName': 'Jin', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, Chungnam National University, Daejeon 35015, Korea.'}, {'ForeName': 'Shin-Seung', 'Initials': 'SS', 'LastName': 'Yang', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, Chungnam National University, Daejeon 35015, Korea.'}, {'ForeName': 'Ja Young', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'Department of Rehabilitation Medicine, Chungnam National University Hospital, Daejeon 35015, Korea.'}, {'ForeName': 'Min Kyun', 'Initials': 'MK', 'LastName': 'Sohn', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, Chungnam National University, Daejeon 35015, Korea.'}]",Brain sciences,['10.3390/brainsci10110801']
1882,33143284,"Satiety, Taste and the Cephalic Phase: A Crossover Designed Pilot Study into Taste and Glucose Response.","The glycemic response produced by a food depends on both the glycemic index of the food itself, and on how the body reacts to the food as it is consumed and digested, in turn dependent on sensory cues. Research suggests that taste stimulation can induce the cephalic phase insulin response before food has reached the digestion, priming the body for an incoming glucose load. This glycemic response can consequently affect the amount of food consumed in a subsequent meal. The aim of this study was to investigate the effects on satiety of four preloads that differed in caloric content and sensory properties, in a small group of female and male participants ( n = 10). Water, sucrose, sucralose, and maltodextrin were used to represent 4 different conditions of the preload, with or without energy, and with or without sweet taste. Individual plasma glucose concentrations were sampled at baseline, 45 min after consuming the preload, and after consuming an ad-libitum test meal. Hunger, fullness, desire to eat, and thoughts of food feeling were assessed every 15 min using visual analog scales. Results in male participants when comparing two solutions of equal caloric content, maltodextrin and sucrose, showed that plasma glucose concentration spiked in the absence of taste input ( p = 0.011). Maltodextrin, while providing calories does not have the sweet taste that can serve to trigger cephalic phase insulin release to attenuate an incoming glucose load, and was accompanied by significantly greater change in feelings of satiety than with the other preloads. Despite the difference in postprandial blood glucose, the energy consumed in the test meal across the treatments was not significantly different in either males or females. Results highlight the importance of taste in stimulating the body for the efficient and effective glucose homeostasis.",2020,"Despite the difference in postprandial blood glucose, the energy consumed in the test meal across the treatments was not significantly different in either males or females.","['a small group of female and male participants ( n = 10', 'male participants']","['Water, sucrose, sucralose, and maltodextrin', 'Maltodextrin']","['Hunger, fullness, desire to eat, and thoughts of food feeling', 'Satiety, Taste and the Cephalic Phase', 'plasma glucose concentration', 'postprandial blood glucose', 'Individual plasma glucose concentrations', 'feelings of satiety', 'glycemic response']","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",,0.0304169,"Despite the difference in postprandial blood glucose, the energy consumed in the test meal across the treatments was not significantly different in either males or females.","[{'ForeName': 'Thanyathorn', 'Initials': 'T', 'LastName': 'Sae Iab', 'Affiliation': 'Department of Food Science, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Dando', 'Affiliation': 'Department of Food Science, Cornell University, Ithaca, NY 14853, USA.'}]","Foods (Basel, Switzerland)",['10.3390/foods9111578']
1883,33143297,Predictive Values of Blood-Based RNA Signatures for the Gemcitabine Response in Advanced Pancreatic Cancer.,"Pancreatic ductal adenocarcinoma (PDAC) is expected to be the second cause of cancer death by 2022. For nearly 80% of patients, diagnosis occurs at an advanced, nonsurgical stage, making such patients incurable. Gemcitabine is still an important component in PDAC treatment and is most often used as a backbone to test new targeted therapies and there is, to date, no routine biomarker to predict its efficacy. Samples from a phase III randomized trial were used to develop through a large approach based on blood-based liquid biopsy, transcriptome profiling, and machine learning, a nine gene predictive signature for gemcitabine sensitivity. Patients with a positive test (41.6%) had a significantly longer progression free survival (PFS) (3.8 months vs. 1.9 months p = 0.03) and a longer overall survival (OS) (14.5 months vs. 5.1, p < 0.0001). In multivariate analyses, this signature was independently associated with PFS (HR = 0.5 (0.28-0.9) p = 0.025) and OS (HR = 0.39 (0.21-0.7) p = 0.002).",2020,Patients with a positive test (41.6%) had a significantly longer progression free survival (PFS) (3.8 months vs. 1.9 months ,"['Advanced Pancreatic Cancer', 'Pancreatic ductal adenocarcinoma (PDAC']",['Gemcitabine'],"['longer overall survival (OS', 'progression free survival (PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0231091,Patients with a positive test (41.6%) had a significantly longer progression free survival (PFS) (3.8 months vs. 1.9 months ,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Piquemal', 'Affiliation': 'Acobiom, 1682 Rue de la Valsière, 34790 Grabels, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Noguier', 'Affiliation': 'Acobiom, 1682 Rue de la Valsière, 34790 Grabels, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Pierrat', 'Affiliation': 'Acobiom, 1682 Rue de la Valsière, 34790 Grabels, France.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Bruno', 'Affiliation': 'Acobiom, 1682 Rue de la Valsière, 34790 Grabels, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Cros', 'Affiliation': 'Department of Pathology, Beaujon Hospital-Université de Paris-INSERM U1149, 92110 Clichy, France.'}]",Cancers,['10.3390/cancers12113204']
1884,33143327,Comparative Study of the Restorative Effects of Forest and Urban Videos during COVID-19 Lockdown: Intrinsic and Benchmark Values.,"The prolonged lockdown imposed to contain the COrona VIrus Disease 19 COVID-19 pandemic prevented many people from direct contact with nature and greenspaces, raising alarms for a possible worsening of mental health. This study investigated the effectiveness of a simple and affordable remedy for improving psychological well-being, based on audio-visual stimuli brought by a short computer video showing forest environments, with an urban video as a control. Randomly selected participants were assigned the forest or urban video, to look at and listen to early in the morning, and questionnaires to fill out. In particular, the State-Trait Anxiety Inventory (STAI) Form Y collected in baseline condition and at the end of the study and the Part II of the Sheehan Patient Rated Anxiety Scale (SPRAS) collected every day immediately before and after watching the video. The virtual exposure to forest environments showed effective to reduce perceived anxiety levels in people forced by lockdown in limited spaces and environmental deprivation. Although significant, the effects were observed only in the short term, highlighting the limitation of the virtual experiences. The reported effects might also represent a benchmark to disentangle the determinants of health effects due to real forest experiences, for example, the inhalation of biogenic volatile organic compounds (BVOC).",2020,The virtual exposure to forest environments showed effective to reduce perceived anxiety levels in people forced by lockdown in limited spaces and environmental deprivation.,[],['Forest and Urban Videos during COVID-19 Lockdown'],"['anxiety levels', 'State-Trait Anxiety Inventory (STAI']",[],"[{'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",,0.0240742,The virtual exposure to forest environments showed effective to reduce perceived anxiety levels in people forced by lockdown in limited spaces and environmental deprivation.,"[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Zabini', 'Affiliation': 'Institute for Bioeconomy, National Research Council, 10 Via Madonna del Piano, I-50019 Sesto Fiorentino (FI), Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Albanese', 'Affiliation': 'Institute for Bioeconomy, National Research Council, 10 Via Madonna del Piano, I-50019 Sesto Fiorentino (FI), Italy.'}, {'ForeName': 'Francesco Riccardo', 'Initials': 'FR', 'LastName': 'Becheri', 'Affiliation': 'Pian dei Termini Forest Therapy Station, 2311 Via Pratorsi, I-51028 San Marcello Piteglio, Italy.'}, {'ForeName': 'Gioele', 'Initials': 'G', 'LastName': 'Gavazzi', 'Affiliation': ""Section of Psychology-Department of Neuroscience, Psychology, Drug Research and Child's Health (NEUROFARBA), University of Florence, 12 Via di San Salvi, I-50135 Firenze, Italy.""}, {'ForeName': 'Fiorenza', 'Initials': 'F', 'LastName': 'Giganti', 'Affiliation': ""Section of Psychology-Department of Neuroscience, Psychology, Drug Research and Child's Health (NEUROFARBA), University of Florence, 12 Via di San Salvi, I-50135 Firenze, Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Giovanelli', 'Affiliation': ""Section of Psychology-Department of Neuroscience, Psychology, Drug Research and Child's Health (NEUROFARBA), University of Florence, 12 Via di San Salvi, I-50135 Firenze, Italy.""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Gronchi', 'Affiliation': ""Section of Psychology-Department of Neuroscience, Psychology, Drug Research and Child's Health (NEUROFARBA), University of Florence, 12 Via di San Salvi, I-50135 Firenze, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Guazzini', 'Affiliation': 'Department of Education, Languages, Intercultural Studies, Literatures, and Psychology (FORLILPSI), University of Florence, 12 Via di San Salvi, I-50135 Firenze, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Laurino', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, 1 Via Giuseppe Moruzzi, I-56124 Pisa, Italy.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation and Physical Medicine, Graduate School of Medicine-Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Marzi', 'Affiliation': ""Section of Psychology-Department of Neuroscience, Psychology, Drug Research and Child's Health (NEUROFARBA), University of Florence, 12 Via di San Salvi, I-50135 Firenze, Italy.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Mastorci', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, 1 Via Giuseppe Moruzzi, I-56124 Pisa, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Meneguzzo', 'Affiliation': 'Institute for Bioeconomy, National Research Council, 10 Via Madonna del Piano, I-50019 Sesto Fiorentino (FI), Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Righi', 'Affiliation': ""Section of Psychology-Department of Neuroscience, Psychology, Drug Research and Child's Health (NEUROFARBA), University of Florence, 12 Via di San Salvi, I-50135 Firenze, Italy.""}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Viggiano', 'Affiliation': ""Section of Psychology-Department of Neuroscience, Psychology, Drug Research and Child's Health (NEUROFARBA), University of Florence, 12 Via di San Salvi, I-50135 Firenze, Italy.""}]",International journal of environmental research and public health,['10.3390/ijerph17218011']
1885,33143353,Effects of Strength vs. Plyometric Training on Change of Direction Performance in Experienced Soccer Players.,"The purpose of this study was to compare how 6 weeks of strength- vs. plyometric training, which were matched upon direction of motion and workload, influences change of direction (COD) performance. Twenty-one experienced male soccer players (age: 22.2 ± 2.7) were pair-matched into a strength- ( n = 10) and a plyometric ( n = 11) training group. CODs of 45°, 90°, 135° and 180° performed from either a 4 m or 20 m approach distance were compared before and after intervention. Results showed no significant difference between groups. Significant effects were only found within the plyometric training group (-3.2% to -4.6%) in 90°, 135° and 180° CODs from 4 m and a 180° COD from a 20 m approach distance. Individual changes in COD performances showed that with the 4 m approach at least 55% and 81% of the strength and plyometric training group, respectively, improved COD performance, while with the 20 m approach at least 66% of both groups improved performance. This study showed that the plyometric training program can improve most CODs, with angles over 90°, although this is dependent on the distance approaching the COD. Considering the limited time of implementing physical conditioning, in addition to regular soccer practice in most soccer environments, the current plyometric training program can be advantageous in improving CODs at maximal intensity.",2020,"Significant effects were only found within the plyometric training group (-3.2% to -4.6%) in 90°, 135° and 180° CODs from 4 m and a 180° COD from a 20 m approach distance.","['Twenty-one experienced male soccer players (age: 22.2 ± 2.7) were pair-matched into a strength- ( n = 10) and a plyometric ( n = 11) training group', 'Experienced Soccer Players']","['plyometric training program', 'Strength vs. Plyometric Training', 'strength- vs. plyometric training', 'plyometric training']","['performance', 'COD performance', 'Change of Direction Performance', 'COD performances', 'direction (COD) performance']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}]",21.0,0.0129942,"Significant effects were only found within the plyometric training group (-3.2% to -4.6%) in 90°, 135° and 180° CODs from 4 m and a 180° COD from a 20 m approach distance.","[{'ForeName': 'Håvard Guldteig', 'Initials': 'HG', 'LastName': 'Rædergård', 'Affiliation': 'Department of Sport Sciences and Physical Education, Nord University, 7600 Levanger, Norway.'}, {'ForeName': 'Hallvard Nygaard', 'Initials': 'HN', 'LastName': 'Falch', 'Affiliation': 'Department of Sport Sciences and Physical Education, Nord University, 7600 Levanger, Norway.'}, {'ForeName': 'Roland van den', 'Initials': 'RVD', 'LastName': 'Tillaar', 'Affiliation': 'Department of Sport Sciences and Physical Education, Nord University, 7600 Levanger, Norway.'}]","Sports (Basel, Switzerland)",['10.3390/sports8110144']
1886,33146706,Using a composite maternal-infant outcome measure in tuberculosis prevention studies among pregnant women.,"BACKGROUND
Tuberculosis (TB) preventive therapy (TPT) among pregnant women reduces the risk of TB in mothers and infants, but the timing of initiation should consider potential adverse effects. We propose an analytical approach to evaluate the risk-benefit of interventions.
METHODS
A novel outcome measure that prioritizes maternal and infant events was developed with a two-stage Delphi survey, where a panel of stakeholders assigned scores from 0 (best) to 100 (worst) based on perceived desirability. Using data from TB APPRISE, a trial among pregnant women living with HIV (WLWH) that randomized the timing of initiation of isoniazid, antepartum versus postpartum, was evaluated.
RESULTS
The composite outcome scoring/ranking system categorized mother-infant paired outcomes into 8 groups assigned identical median scores by stakeholders. Maternal/infant TB and non-severe adverse pregnancy outcome were assigned similar scores. The mean (SD) composite outcome scores were 43.7 (33.0) and 41.2 (33.7) in the antepartum and postpartum TPT initiation arms, respectively. However, a modifying effect of baseline antiretroviral regimen was detected (p=0.049). When women received nevirapine composite scores were higher (worse outcomes) in the antepartum versus postpartum arms (adjusted difference=14.3; 95% CI: 2.4 - 26.2; p=0.02), whereas when women received efavirenz there was no difference by timing of TPT (adjusted difference=0.62; 95%CI: -3.2 to 6.2; p=0.53).
CONCLUSIONS
For TPT, when used by otherwise healthy persons, preventing adverse events is paramount from the perspective of stakeholders. Among pregnant WLWH in high TB burden regions, it is important to consider the antepartum antiretroviral regimen taken when deciding when to initiate TPT.",2020,"When women received nevirapine composite scores were higher (worse outcomes) in the antepartum versus postpartum arms (adjusted difference=14.3; 95% CI: 2.4 - 26.2; p=0.02), whereas when women received efavirenz there was no difference by timing of TPT (adjusted difference=0.62; 95%CI: -3.2 to 6.2; p=0.53).
","['pregnant women', 'pregnant women living with HIV (WLWH', 'prioritizes maternal and infant events was developed with a two-stage Delphi survey, where a panel of stakeholders assigned scores from 0 (best) to 100 (worst) based on perceived desirability']","['Tuberculosis (TB) preventive therapy (TPT', 'efavirenz', 'nevirapine']","['mean (SD) composite outcome scores', 'Maternal/infant TB and non-severe adverse pregnancy outcome']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037408', 'cui_str': 'Social Desirability'}]","[{'cui': 'C0740413', 'cui_str': 'Tuberculosis prophylaxis'}, {'cui': 'C0050127', 'cui_str': '9 alpha,11 alpha,15 alpha-trihydroxy-16-phenoxy-17,18,19,20-tetranorprosta-4,5,13-trienoic acid'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}]",,0.354293,"When women received nevirapine composite scores were higher (worse outcomes) in the antepartum versus postpartum arms (adjusted difference=14.3; 95% CI: 2.4 - 26.2; p=0.02), whereas when women received efavirenz there was no difference by timing of TPT (adjusted difference=0.62; 95%CI: -3.2 to 6.2; p=0.53).
","[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Montepiedra', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Soyeon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Frontier Science Foundation, Boston, MA, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Weinberg', 'Affiliation': 'University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Theron', 'Affiliation': 'Stellenbosch University, Cape Town,SA.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Sterling', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Sylvia M', 'Initials': 'SM', 'LastName': 'LaCourse', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bradford', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Jean-Philippe', 'Affiliation': 'National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Evans', 'Affiliation': 'The George Washington University, Washington DC, USA.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1674']
1887,33146720,Induction of Cross-reactive Hemagglutination Inhibiting Antibody and Polyfunctional CD4+ T-cell Responses by a Recombinant Matrix-M-Adjuvanted Hemagglutinin Nanoparticle Influenza Vaccine.,"BACKGROUND
Recurrent reports of suboptimal influenza vaccine effectiveness have renewed calls to develop improved, broadly cross-protective influenza vaccines. Here, we evaluated the safety and immunogenicity of a novel, saponin (Matrix-M)-adjuvanted, recombinant hemagglutinin (HA) quadrivalent nanoparticle influenza vaccine (qNIV).
METHODS
We conducted a randomized, observer-blind, comparator-controlled (trivalent high-dose inactivated influenza vaccine [IIV3-HD], or quadrivalent recombinant influenza vaccine [RIV4]), safety and immunogenicity trial of qNIV (in 5 different doses/formulations) in healthy adults aged ≥65 years. Vaccine immunogenicity was measured by hemagglutination-inhibition assays using reagents expressing wild-type HA sequences (wt-HAI) and cell-mediated immune (CMI) responses.
RESULTS
A total of 1375 participants were randomized, immunized, and followed for safety and immunogenicity. Matrix-M-adjuvanted qNIV induced superior wt-HAI antibody responses against 5 of 6 homologous or drifted strains evaluated compared to unadjuvanted qNIV. Adjuvanted qNIV induced post-vaccination wt-HAI antibody responses at Day 28 that were: statistically higher than IIV3-HD against a panel of homologous or drifted A/H3N2 strains; similar to IIV3-HD against homologous A/H1N1 and B (Victoria) strains; and similar to RIV4 against all homologous and drifted strains evaluated. The qNIV formulation with 75 µg Matrix-M adjuvant induced substantially higher post-vaccination geometric mean fold-increases of influenza HA-specific polyfunctional CD4+ T-cells compared to IIV3-HD or RIV4. Overall, similar frequencies of solicited and unsolicited adverse events (AEs) were reported in all treatment groups.
CONCLUSIONS
qNIV with 75 µg Matrix-M adjuvant was well tolerated and induced robust antibody and cellular responses, notably against both homologous and drifted A/H3N2 viruses. Further investigation in a pivotal phase 3 trial is underway.",2020,"Overall, similar frequencies of solicited and unsolicited adverse events (AEs) were reported in all treatment groups.
","['healthy adults aged ≥65 years', '1375 participants']","['novel, saponin (Matrix-M)-adjuvanted, recombinant hemagglutinin (HA) quadrivalent nanoparticle influenza vaccine (qNIV', 'qNIV', 'comparator-controlled (trivalent high-dose inactivated influenza vaccine [IIV3-HD], or quadrivalent recombinant influenza vaccine [RIV4', 'Cross-reactive Hemagglutination Inhibiting Antibody and Polyfunctional CD4+ T-cell Responses by a Recombinant Matrix-M-Adjuvanted Hemagglutinin Nanoparticle Influenza Vaccine']","['influenza HA-specific polyfunctional CD4+ T-cells', 'safety and immunogenicity', 'frequencies of solicited and unsolicited adverse events (AEs', 'Vaccine immunogenicity']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036189', 'cui_str': 'Saponins'}, {'cui': 'C4549501', 'cui_str': 'Matrix-M'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0010357', 'cui_str': 'Cross Reactions'}, {'cui': 'C0018903', 'cui_str': 'Hemagglutination'}, {'cui': 'C0301846', 'cui_str': 'Incomplete antibody'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4277607', 'cui_str': 'Antigenicity, Vaccine'}]",1375.0,0.054145,"Overall, similar frequencies of solicited and unsolicited adverse events (AEs) were reported in all treatment groups.
","[{'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Shinde', 'Affiliation': 'Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Rongman', 'Initials': 'R', 'LastName': 'Cai', 'Affiliation': 'Previously with Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Plested', 'Affiliation': 'Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Iksung', 'Initials': 'I', 'LastName': 'Cho', 'Affiliation': 'Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Fiske', 'Affiliation': 'Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Pham', 'Affiliation': 'Previously with Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Mingzhu', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Cloney-Clark', 'Affiliation': 'Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Previously with Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Massare', 'Affiliation': 'Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Fix', 'Affiliation': 'Previously with Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Spindler', 'Affiliation': 'Previously with Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'David Nigel', 'Initials': 'DN', 'LastName': 'Thomas', 'Affiliation': 'Previously with Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Gale', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': 'Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Fries', 'Affiliation': 'Novavax, Inc., Gaithersburg, MD, USA.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Glenn', 'Affiliation': 'Novavax, Inc., Gaithersburg, MD, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1673']
1888,33143164,Using the Systemic Immune-Inflammation Index (SII) as a Mid-Treatment Marker for Survival among Patients with Stage-III Locally Advanced Non-Small Cell Lung Cancer (NSCLC).,"The Systemic Immune-Inflammation Index (SII) is an important marker of immune function, defined as the product of neutrophil-to-lymphocyte ratio (NLR) and platelet count (P). Higher baseline SII levels have been associated with improved survival in various types of cancers, including lung cancer. Data were obtained from PROCLAIM, a randomized phase III trial comparing two different chemotherapy regimens pemetrexed + cisplatin (PEM) vs. etoposide + cisplatin (ETO), in combination with radiotherapy (RT) for the treatment of stage III non-squamous non-small cell lung cancer (NSCLC). We aimed to determine if SII measured at the mid-treatment window for RT (weeks 3-4) is a significant predictor of survival, and if the effect of PEM vs. ETO differs by quartile (Q) level of SII. Hazard-ratios (HR) for survival were estimated using a proportional hazards model, accounting for the underlying correlated structure of the data. A total of 548 patients were included in our analysis. The median age at baseline was 59 years. Patients were followed for a median of 24 months. Adjusting for age, body mass index, sex, race, and chemotherapy regimen, SII was a significant mid-treatment predictor of both overall (adjusted HR (aHR) = 1.6, p < 0.0001; OS) and progression-free (aHR = 1.3, p = 0.0072; PFS) survival. Among patients with mid-RT SII values above the median (6.8), those receiving PEM (vs. ETO) had superior OS ( p = 0.0002) and PFS ( p = 0.0002). Our secondary analysis suggests that SII is an informative mid-treatment marker of OS and PFS in locally advanced non-squamous NSCLC.",2020,"Among patients with mid-RT SII values above the median (6.8), those receiving PEM (vs. ETO) had superior OS ( p = 0.0002) and PFS ( p = 0.0002).","['Locally Advanced Non-Small Cell Lung Cancer (NSCLC', 'A total of 548 patients were included in our analysis', 'Patients with Stage-III', 'stage III non-squamous non-small cell lung cancer (NSCLC']","['chemotherapy regimens pemetrexed + cisplatin (PEM) vs. etoposide + cisplatin (ETO), in combination with radiotherapy (RT']","['PFS) survival', 'superior OS', 'Hazard-ratios (HR) for survival', 'Systemic Immune-Inflammation Index (SII']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}]","[{'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",548.0,0.124216,"Among patients with mid-RT SII values above the median (6.8), those receiving PEM (vs. ETO) had superior OS ( p = 0.0002) and PFS ( p = 0.0002).","[{'ForeName': 'Tithi', 'Initials': 'T', 'LastName': 'Biswas', 'Affiliation': 'Department of Radiation Oncology, University Hospitals, Case Western Reserve University, Cleveland, OH 44106, USA.'}, {'ForeName': 'Kylie H', 'Initials': 'KH', 'LastName': 'Kang', 'Affiliation': 'Department of Radiation Oncology, Washington University School of Medicine and Alvin J. Siteman Comprehensive Cancer Center, St. Louis, MO 63110, USA.'}, {'ForeName': 'Rohin', 'Initials': 'R', 'LastName': 'Gawdi', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bajor', 'Affiliation': 'Medical Oncology, Seidman Cancer Center, Case Western Reserve University, Cleveland, OH 44106, USA.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Machtay', 'Affiliation': 'Department of Radiation Oncology, Penn State University, Hershey, PA 17033, USA.'}, {'ForeName': 'Charu', 'Initials': 'C', 'LastName': 'Jindal', 'Affiliation': 'Faculty of Science, University of Newcastle, Newcastle 2308, Australia.'}, {'ForeName': 'Jimmy T', 'Initials': 'JT', 'LastName': 'Efird', 'Affiliation': 'Cooperative Studies Program Epidemiology Center, Health Services Research and Development (DVAHCS/Duke Affiliated Center), Durham, NC 27705, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17217995']
1889,33143178,Effects of Task-Specific and Strength Training on Simulated Military Task Performance in Soldiers.,"A soldier's occupational physical task requirements are diverse and varied. However, the type of physical training that most effectively improves soldiers' occupational task requirements has not been studied previously. The purpose of this study was to determine the important strength characteristics for soldiers during a repeated simulated military task course, and the type of training that may be effective to improve these abilities during a specialized military training period. Forty-two ( n = 42) soldiers participated in the study. They were divided into three training groups; a soldier task-specific training group (TSG, n = 17), a strength training group (STG, n = 15), and a control group (CON, n = 10). Participants were measured before (PRE), middle (MID) and after (POST) the 12-week training intervention for strength performance and simulated military task test. Simulated military task performance improved significantly in TSG and STG between the PRE and MID measurements (from 9.4 to 15.7%). TSG and STG improved in various spilt times, especially in strength tasks; casualty drag (from 8.3 to 13.6%) and kettlebell carry (from 13.2 to 22.4%) between the PRE and MID measurements. The present study showed that both the training of TSG and STG were more effective than the training of CON (control group) in terms of improving the performance in the repeated simulated military task course. The present study showed that training of TSG was as effective as STG to improve repeated simulated military task course time. Therefore, an optimal training combination should include high-intensity simulated military task field training and strength training programmed with consideration of the military training phase and environmental possibilities.",2020,"TSG and STG improved in various spilt times, especially in strength tasks; casualty drag (from 8.3 to 13.6%) and kettlebell carry (from 13.2 to 22.4%) between the PRE and MID measurements.","['Forty-two ( n = 42) soldiers participated in the study', 'Soldiers']","['CON', 'TSG', 'Task-Specific and Strength Training', 'soldier task-specific training group (TSG, n = 17), a strength training group (STG']","['TSG and STG between the PRE and MID measurements', 'Simulated military task performance', 'strength tasks; casualty drag', ""soldiers' occupational task requirements"", 'Simulated Military Task Performance']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C1562415', 'cui_str': 'Skin drag'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}]",42.0,0.0100982,"TSG and STG improved in various spilt times, especially in strength tasks; casualty drag (from 8.3 to 13.6%) and kettlebell carry (from 13.2 to 22.4%) between the PRE and MID measurements.","[{'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Ojanen', 'Affiliation': 'Finnish Defence Research Agency, Finnish Defence Forces, P.O. Box 5, 04401 Järvenpää, Finland.'}, {'ForeName': 'Keijo', 'Initials': 'K', 'LastName': 'Häkkinen', 'Affiliation': 'Biology of Physical Activity, Faculty of Sport and Health Sciences, University of Jyväskylä, P.O. Box 35, 40014 Jyväskylä, Finland.'}, {'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Hanhikoski', 'Affiliation': 'Biology of Physical Activity, Faculty of Sport and Health Sciences, University of Jyväskylä, P.O. Box 35, 40014 Jyväskylä, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Kyröläinen', 'Affiliation': 'Biology of Physical Activity, Faculty of Sport and Health Sciences, University of Jyväskylä, P.O. Box 35, 40014 Jyväskylä, Finland.'}]",International journal of environmental research and public health,['10.3390/ijerph17218000']
1890,33143203,The Impact of Micronutrient Fortified Foods on Cognitive Functioning among Low-Income Children: A Pilot and Feasibility Study.,"Brain development continues throughout childhood and requires micronutrients for optimal maturation, but studies have typically examined only a limited number of micronutrients and there has been inconsistent use of validated cognitive measures. This study evaluated the impact of providing low-income children with a daily fortified meal (570 kcal) in the form of a bar and shake containing >75% of the FDA Daily Values for all essential vitamins and minerals, as well as macronutrients (e.g., omega-3 and omega-6 fatty acids and protein), in an afterschool care setting (instead of the usual meal provided) on cognitive functioning. Students aged 8-12 were randomly assigned to intervention ( n = 19) or control ( n = 16) meals. Students completed the Stroop Color Word Task, Trail Making Test, and Conner's Continuous Performance Task (CPT) at baseline and 3 months post-intervention. Differences in cognitive scores were examined using 2 × 2 mixed model ANOVAs (Stroop and CPT) and ANCOVAs (Trail Making Test). Significant main effects of time indicated improvements in both intervention and control groups, but there were no significant main effects of group or group*time interactions. When the amount of meal consumed was examined, most results became non-significant, suggesting that overall meal consumption significantly impacted the observed results. Overall, this pilot study suggests that there may be limited additional benefits to short-term consumption of micronutrient fortified meals among low-income children in an afterschool care setting, and potential benefits observed may be directly related to the amount of food consumed.",2020,"Significant main effects of time indicated improvements in both intervention and control groups, but there were no significant main effects of group or group*time interactions.","['Low-Income Children', 'Students aged 8-12']","['Micronutrient Fortified Foods', 'daily fortified meal']","[""Stroop Color Word Task, Trail Making Test, and Conner's Continuous Performance Task (CPT"", 'Cognitive Functioning', 'overall meal consumption', 'cognitive scores']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C4329232', 'cui_str': 'AX-CPT'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0236265,"Significant main effects of time indicated improvements in both intervention and control groups, but there were no significant main effects of group or group*time interactions.","[{'ForeName': 'Juliana F W', 'Initials': 'JFW', 'LastName': 'Cohen', 'Affiliation': 'Department of Public Health and Nutrition, Merrimack College, 315 Turnpike Street, North Andover, MA 01845, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Sagar', 'Affiliation': 'Cognitive and Clinical Neuroimaging Core, McLean Hospital, Belmont, MA 02478, USA.'}, {'ForeName': 'Mary Kathryn', 'Initials': 'MK', 'LastName': 'Dahlgren', 'Affiliation': 'Cognitive and Clinical Neuroimaging Core, McLean Hospital, Belmont, MA 02478, USA.'}, {'ForeName': 'Laura B F', 'Initials': 'LBF', 'LastName': 'Kurdziel', 'Affiliation': 'Department of Psychology, Merrimack College, North Andover, MA 01845, USA.'}, {'ForeName': 'Staci A', 'Initials': 'SA', 'LastName': 'Gruber', 'Affiliation': 'Cognitive and Clinical Neuroimaging Core, McLean Hospital, Belmont, MA 02478, USA.'}]",Nutrients,['10.3390/nu12113351']
1891,33143212,Effect of Phaseolus Vulgaris on Urinary Biochemical Parameters among Patients with Kidney Stones in Saudi Arabia.,"The study purpose was to investigate the effect of Phaseolus Vulgaris (PV) on urinary biochemical parameters among patients with kidney stones. We conducted a randomized controlled study among 60 patients with kidney stones (size < 10 mm) in the nephrology unit of both government and private hospitals, Al-Ahsa. Urinary volume, calcium, magnesium, potassium, oxalate, uric acid, and power of hydrogen (pH) were assessed before and after the intervention of giving 250 g of PV consumption as an extract thrice weekly (2.2 L to 2.5 L per week) for 6 weeks, which was compared with control. A 't' test was used with the significance at 5%. Mean score of age was 44.5 ± 10.16 in PV group and 43.73 ± 9.79 in control. Four (13.3%) and two (6.7%) had family history of kidney stones. Body mass Index (BMI) mean was 26.44 ± 2.7 and 26.36 ± 2.65 in pre and post-test, respectively, which were significant ( p = 0.01017). There were significant changes ( p = 0.000) in urine volume from 1962 ± 152.8 to 2005 ± 148.8, calcium 205.4 ± 11.99 to 198.4 ± 12.52, potassium 44.07 ± 3.66 to 52.15 ± 4.37, oxalate 37.12 ± 5.38 to 33.02 ± 5.71, and uric acid 6.88 ± 0.7 to 6.31 ± 0.58. In conclusion, PV is effective management for the patients with kidney stones as it increases the urinary volume and enhances the elimination of small kidney stones.",2020,"There were significant changes ( p = 0.000) in urine volume from 1962 ± 152.8 to 2005 ± 148.8, calcium 205.4 ± 11.99 to 198.4 ± 12.52, potassium 44.07 ± 3.66 to 52.15 ± 4.37, oxalate 37.12 ± 5.38 to 33.02 ± 5.71, and uric acid 6.88 ± 0.7 to 6.31 ± 0.58.","['Patients with Kidney Stones in Saudi Arabia', '60 patients with kidney stones (size < 10 mm) in the nephrology unit of both government and private hospitals, Al-Ahsa', 'patients with kidney stones']","['Phaseolus Vulgaris', 'Phaseolus Vulgaris (PV', 'PV']","['family history of kidney stones', 'Urinary Biochemical Parameters', 'urinary biochemical parameters', 'Urinary volume, calcium, magnesium, potassium, oxalate, uric acid, and power of hydrogen (pH', 'Body mass Index (BMI) mean']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0033173', 'cui_str': 'Private hospital'}]","[{'cui': 'C0973452', 'cui_str': 'Kidney Bean'}]","[{'cui': 'C1563033', 'cui_str': 'Family history of renal stone'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0029988', 'cui_str': 'Oxalate'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",60.0,0.0544148,"There were significant changes ( p = 0.000) in urine volume from 1962 ± 152.8 to 2005 ± 148.8, calcium 205.4 ± 11.99 to 198.4 ± 12.52, potassium 44.07 ± 3.66 to 52.15 ± 4.37, oxalate 37.12 ± 5.38 to 33.02 ± 5.71, and uric acid 6.88 ± 0.7 to 6.31 ± 0.58.","[{'ForeName': 'Sahbanathul Missiriya', 'Initials': 'SM', 'LastName': 'Jalal', 'Affiliation': 'Department of Nursing, College of Applied Medical Science, King Faisal University, Al-Ahsa 31982, Saudi Arabia.'}, {'ForeName': 'Abdulrahman Abdulhadi', 'Initials': 'AA', 'LastName': 'Alsultan', 'Affiliation': 'Department of Biomedical Sciences, College of Medicine, King Faisal University, Al-Ahsa 31982, Saudi Arabia.'}, {'ForeName': 'Hala Hazam', 'Initials': 'HH', 'LastName': 'Alotaibi', 'Affiliation': 'Department of Food and Nutrition Sciences, College of Agriculture and Food Sciences, King Faisal University, Al-Ahsa 31982, Saudi Arabia.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Mary', 'Affiliation': 'Department of Pediatrics, King Khalid Hospital, Najran 66262, Saudi Arabia.'}, {'ForeName': 'Abeer Abbas Ibrahim', 'Initials': 'AAI', 'LastName': 'Alabdullatif', 'Affiliation': 'Department of Nursing, College of Applied Medical Science, King Faisal University, Al-Ahsa 31982, Saudi Arabia.'}]",Nutrients,['10.3390/nu12113346']
1892,33143369,Vitamin D and Calcium Milk Fortification in Pregnant Women with Periodontitis: A Feasibility Trial.,"This study aims to assess the acceptability, adherence, and retention of a feasibility trial on milk fortification with calcium and vitamin D (Ca+VitD) and periodontal therapy (PT) among low income Brazilian pregnant women with periodontitis (IMPROVE trial). This 2 × 2 factorial feasibility trial used a mixed-methods evaluation. In total, 69 pregnant women were randomly allocated to four groups: 1. fortified sachet with Ca+VitD and milk plus early PT (throughout gestation); 2. placebo and milk plus early PT; 3. fortified sachet with Ca+VitD and milk plus late PT after childbirth; 4. placebo and milk plus late PT. Data were collected via questionnaires, field notes, participant flow logs, treatment diary, and focal group discussions. Quantitative and qualitative data were analysed using appropriate descriptive statistics and content analysis, respectively. Eligibility rate (12%) was below the target of 15%, but participation (76.1%) and recruitment rate (2 women/week) exceeded the targets. Retention rate (78.6%) was slightly below the target (80%). Adherence to the PT was significantly higher in the early treatment groups (98.8%) compared to the late treatment groups (29%). All women accepted the random allocation, and baseline groups were balanced. There was no report of adverse events. This multi-component intervention is acceptable, well-tolerated, and feasible among low-risk pregnant women in Brazil.",2020,Adherence to the PT was significantly higher in the early treatment groups (98.8%) compared to the late treatment groups (29%).,"['69 pregnant women', 'Pregnant Women with Periodontitis', 'low-risk pregnant women in Brazil', 'low income Brazilian pregnant women with periodontitis (IMPROVE trial']","['placebo and milk plus early PT; 3. fortified sachet with Ca+VitD and milk plus late PT', 'fortified sachet with Ca+VitD and milk plus early PT', 'placebo and milk plus late PT', 'Vitamin D and Calcium Milk Fortification', 'milk fortification with calcium and vitamin D (Ca+VitD) and periodontal therapy (PT']","['adverse events', 'Adherence to the PT', 'Eligibility rate', 'Retention rate']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0026136', 'cui_str': 'Milk of Calcium'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",69.0,0.103047,Adherence to the PT was significantly higher in the early treatment groups (98.8%) compared to the late treatment groups (29%).,"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Rodrigues Amorim Adegboye', 'Affiliation': 'School of Human Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, Park Row, London SE10 9 LS, UK.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Dias Santana', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil.'}, {'ForeName': 'Paula Guedes', 'Initials': 'PG', 'LastName': 'Cocate', 'Affiliation': 'Department of Bioscience and Physical Activity, School of Physical Education and Sports, Federal University of Rio de Janeiro, 21941-599 Rio de Janeiro, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Benaim', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil.'}, {'ForeName': 'Pedro Paulo', 'Initials': 'PP', 'LastName': 'Teixeira Dos Santos', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil.'}, {'ForeName': 'Berit Lilienthal', 'Initials': 'BL', 'LastName': 'Heitmann', 'Affiliation': 'Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region, Denmark and Section for General Medicine, Institute of Public Health, Copenhagen University, 2000 Copenhagen, Denmark.'}, {'ForeName': 'Maria Cláudia', 'Initials': 'MC', 'LastName': 'da Veiga Soares Carvalho', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil.'}, {'ForeName': 'Michael Maia', 'Initials': 'MM', 'LastName': 'Schlüssel', 'Affiliation': 'The EQUATOR Network-UK Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Old Road, Oxford OX3 7LD, UK.'}, {'ForeName': 'Maria Beatriz', 'Initials': 'MB', 'LastName': 'Trindade de Castro', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Kac', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17218023']
1893,33143432,Pre-bypass levosimendan in ventricular dysfunction-effect on right ventricle.,"BACKGROUND
Levosimendan is an effective calcium sensitizer with complementary mechanisms of action: calcium sensitization and opening of adenosine triphosphate-dependent potassium channels, both on the sarcolemma of the smooth muscle cells in the vasculature and on the mitochondria of cardiomyocytes. Levosimendan has a long-acting metabolite with a half-life of approximately 80 h. There have been a few small studies on this drug regarding right ventricular function. In view of this, we investigated the effect of levosimendan on right ventricular function in patients with coronary artery disease.
METHODS
This was a prospective, randomized, double-blind study on 50 patients with coronary artery disease and severe left ventricular dysfunction (left ventricular ejection fraction ≤35%) undergoing elective off-pump coronary artery bypass.
RESULTS
Levosimendan had an inotropic effect on right ventricular myocardium and a vasodilatory effect on blood vessels. It caused a decline in pulmonary vascular resistance ( p < 0.018), right ventricular systolic pressure ( p < 0.001), and pulmonary artery systolic pressure ( p < 0.001), and improved right ventricular diastolic function as shown by the decrease in right ventricular Tei index ( p < 0.001), right ventricular end-diastolic pressure, and the ratio of early diastolic tricuspid inflow to tricuspid lateral annular velocity ( p < 0.006). However, we found no beneficial effects on intensive care unit or hospital stay ( p = 0.164, p = 0.349, respectively) nor a mortality benefit.
CONCLUSIONS
Levosimendan has salutary effects on right ventricular function in patients with severe left ventricular dysfunction undergoing coronary artery bypass, in terms of improved hemodynamic parameters.",2020,"It caused a decline in pulmonary vascular resistance ( p < 0.018), right ventricular systolic pressure ( p < 0.001), and pulmonary artery systolic pressure ( p < 0.001), and improved right ventricular diastolic function as shown by the decrease in right ventricular Tei index ( p < 0.001), right ventricular end-diastolic pressure, and the ratio of early diastolic tricuspid inflow to tricuspid lateral annular velocity ( p < 0.006).","['50 patients with coronary artery disease and severe left ventricular dysfunction (left ventricular ejection fraction ≤35%) undergoing elective off-pump coronary artery bypass', 'patients with severe left ventricular dysfunction undergoing coronary artery bypass', 'patients with coronary artery disease']","['levosimendan', 'Levosimendan', 'Pre-bypass levosimendan']","['pulmonary vascular resistance', 'pulmonary artery systolic pressure', 'right ventricular function', 'right ventricular end-diastolic pressure, and the ratio of early diastolic tricuspid inflow to tricuspid lateral annular velocity', 'mortality benefit', 'right ventricular systolic pressure', 'right ventricular diastolic function', 'right ventricular Tei index', 'intensive care unit or hospital stay', 'inotropic effect on right ventricular myocardium and a vasodilatory effect on blood vessels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242973', 'cui_str': 'Ventricular dysfunction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}]","[{'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}, {'cui': 'C0080311', 'cui_str': 'Right ventricular function'}, {'cui': 'C0456183', 'cui_str': 'Right ventricular end-diastolic pressure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0443327', 'cui_str': 'Tricuspid'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456181', 'cui_str': 'Right ventricular systolic pressure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0225885', 'cui_str': 'Structure of myocardium of right ventricle'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",50.0,0.0631737,"It caused a decline in pulmonary vascular resistance ( p < 0.018), right ventricular systolic pressure ( p < 0.001), and pulmonary artery systolic pressure ( p < 0.001), and improved right ventricular diastolic function as shown by the decrease in right ventricular Tei index ( p < 0.001), right ventricular end-diastolic pressure, and the ratio of early diastolic tricuspid inflow to tricuspid lateral annular velocity ( p < 0.006).","[{'ForeName': 'Dhanesh', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Department of Cardiac Surgery, National Heart Institute, New Delhi, India.'}, {'ForeName': 'Om Prakash', 'Initials': 'OP', 'LastName': 'Yadava', 'Affiliation': 'Department of Cardiac Surgery, National Heart Institute, New Delhi, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Ahlawat', 'Affiliation': 'Department of Cardiac Surgery, National Heart Institute, New Delhi, India.'}, {'ForeName': 'Anirban', 'Initials': 'A', 'LastName': 'Kundu', 'Affiliation': 'Department of Cardiac Surgery, National Heart Institute, New Delhi, India.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Yadav', 'Affiliation': 'Department of Cardiac Surgery, National Heart Institute, New Delhi, India.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Prakash', 'Affiliation': 'Department of Cardiac Surgery, National Heart Institute, New Delhi, India.'}]",Asian cardiovascular & thoracic annals,['10.1177/0218492320972891']
1894,33143436,Letter to the editor concerning the article: Scapular exercise combined with cognitive functional therapy is more effective at reducing chronic neck pain and kinesiophobia than scapular exercise alone: A randomized controlled trial.,,2020,,[],['Scapular exercise combined with cognitive functional therapy'],[],[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.128193,,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Castro', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Centro Universitário Augusto Motta, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Luciana C', 'Initials': 'LC', 'LastName': 'Lunkes', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Centro Universitário Augusto Motta, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Menezes', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Centro Universitário Augusto Motta, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Ney', 'Initials': 'N', 'LastName': 'Meziat-Filho', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Centro Universitário Augusto Motta, Rio de Janeiro, RJ, Brazil.'}]",Clinical rehabilitation,['10.1177/0269215520967940']
1895,33143451,Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine.,"INTRODUCTION
Acute medication overuse is prevalent in patients with migraine.
METHODS
In three phase 3, double-blind, randomized, placebo-controlled studies, patients with episodic migraine (EVOLVE-1 and EVOLVE-2) or chronic migraine (REGAIN) were randomized 2:1:1 to monthly subcutaneous injections of placebo or galcanezumab 120 or 240 mg for 3 or 6 months. This subgroup analysis evaluated mean changes in the number of monthly migraine headache days in each treatment among patients with versus without baseline acute medication overuse via mixing modelling with repeated measures.
RESULTS
The percentages of patients with baseline medication overuse in placebo, galcanezumab 120-mg and 240-mg groups, respectively, were 19.4%, 17.3%, and 19.3% for EVOLVE-1/-2 (pooled; post hoc ), and 63.4%, 64.3%, and 64.1% for REGAIN ( a priori ). Both galcanezumab doses demonstrated significant improvement compared with placebo for overall least squares mean change in monthly migraine headache days in patients with baseline medication overuse in both the episodic and chronic migraine studies ( p ≤ 0.001). Furthermore, both galcanezumab doses reduced average monthly medication overuse rates compared to placebo ( p < 0.001) in both patient populations with medication overuse at baseline.
CONCLUSIONS
Galcanezumab appears to be effective for the preventive treatment of episodic and chronic migraine in patients who overuse acute medications. Trial registration: ClinicalTrials.gov Identifiers: NCT02614183, NCT02614196, and NCT02614261.",2020,Both galcanezumab doses demonstrated significant improvement compared with placebo for overall least squares mean change in monthly migraine headache days in patients with baseline medication overuse in both the episodic and chronic migraine studies ( p ≤ 0.001).,"['patients with episodic migraine (EVOLVE-1 and EVOLVE-2) or chronic migraine (REGAIN', 'patients with migraine', 'patients who overuse acute medications']","['placebo, galcanezumab', 'placebo or galcanezumab', 'galcanezumab', 'Galcanezumab', 'placebo']",['average monthly medication overuse rates'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4694273', 'cui_str': 'galcanezumab'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3266697', 'cui_str': 'Medication overuse'}]",,0.368035,Both galcanezumab doses demonstrated significant improvement compared with placebo for overall least squares mean change in monthly migraine headache days in patients with baseline medication overuse in both the episodic and chronic migraine studies ( p ≤ 0.001).,"[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Department of Neurology, Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Erin G', 'Initials': 'EG', 'LastName': 'Doty', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Sheena K', 'Initials': 'SK', 'LastName': 'Aurora', 'Affiliation': 'Impel Neuropharma, 201 Elliott Avenue West, Seattle, WA, USA.'}, {'ForeName': 'Dustin D', 'Initials': 'DD', 'LastName': 'Ruff', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Virginia L', 'Initials': 'VL', 'LastName': 'Stauffer', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Jedynak', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420966658']
1896,33143484,"Expression of Concern: The effects of vitamin D and evening primrose oil co-supplementation on lipid profiles and biomarkers of oxidative stress in vitamin D-deficient women with polycystic ovary syndrome: A randomized, double-blind, placebo-controlled trial.",,2020,,['vitamin D-deficient women with polycystic ovary syndrome'],"['placebo', 'vitamin D and evening primrose oil co-supplementation']",['lipid profiles and biomarkers of oxidative stress'],"[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0700602', 'cui_str': 'Evening primrose oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.73287,,[],Endocrine research,['10.1080/07435800.2020.1843877']
1897,33143639,A preinstalled nasopharyngeal airway in the right nasal passageway to facilitate nasogastric intubation in anesthetized and intubated patients: a prospective randomized controlled trial.,"BACKGROUND
Nasogastric intubation (NGI) is usually challenging in patients under general anesthesia, with reported success rate at the first attempt to be less than 50%. The aim of this study was to investigate whether a preinstalled nasopharyngeal airway (NPA) in the right nasal passageway can facilitate NGI in anesthetized and intubated patients.
METHODS
A prospective randomized controlled trial including 108 patients scheduled for elective intra-abdominal surgeries requiring a nasogastric tube (NGT) was conducted. Fifty-three patients were randomized to receive NGI through a preinstalled NPA in the right nasal passageway (Group NPA) and 55 patients to receive NGI via the right nostril (Group O). The primary outcomes were success rates of NGI at first attempt, success rates of NGI in accumulative attempts, durations of successful NGI at the first attempt and success rates of NGI for the rescuing methods. The secondary outcomes were bleeding incidence and hemodynamic changes induced by NGI.
RESULTS
Success rate of NGI at the first attempt was 83.0% in Group NPA compared with 47.3% in Group O [P < 0.001; absolute risk reduction (ARR) = 35.7%, 95% confidence interval (CI) = 19.1-52.4%; relative risk reduction (RRR) = 67.8%] and success rate of NGI in accumulative attempts (two attempts maximum) was 88.7% in Group NPA compared with 63.6% in Group O (P = 0.002; ARR = 25.0%, 95% CI = 9.7-40.4%; RRR = 68.9%). Duration for NGI successful at the first attempt in Group NPA was significantly longer than that in Group O (56.3 vs. 27.1 s; P < 0.001; Mean difference = 29.2 s, 95% CI = 20.0-38.4 s). Neither bleeding incidence nor hemodynamic response is significantly different between the two study groups.
CONCLUSIONS
The study indicates a preinstalled NPA in the right nasal passageway facilitates NGI in anesthetized and intubated patients as an initial NGI method and as a rescuing method for patients undergoing two unsuccessful initial attempts of NGI without a preinstalled NPA. However, the NPA method proved to take more time than the routine method for NGI successful at the first attempt.
TRIAL REGISTRATION
The study was conducted after receiving approval from Institutional Review Board of Chang Gung Memorial Hospital, Linkou branch, Taiwan (registration number 201800138A3; April 11, 2018), and the clinicaltrials.gov (NCT03697642; Principal Investigator: Ting-Yang Huang; Date of registration: October 4, 2018; https://www.clinicaltrials.gov/NCT03697642 ).",2020,"However, the NPA method proved to take more time than the routine method for NGI successful at the first attempt.
","['patients undergoing two unsuccessful initial attempts of NGI without a preinstalled NPA', 'Fifty-three patients', 'anesthetized and intubated patients', '108 patients scheduled for elective intra-abdominal surgeries requiring a']","['NGI through a preinstalled NPA in the right nasal passageway (Group NPA) and 55 patients to receive NGI via the right nostril', 'nasogastric tube (NGT', 'preinstalled nasopharyngeal airway (NPA', 'Nasogastric intubation (NGI']","['bleeding incidence and hemodynamic changes induced by NGI', 'Duration for NGI successful', 'success rates of NGI at first attempt, success rates of NGI in accumulative attempts, durations of successful NGI at the first attempt and success rates of NGI', 'bleeding incidence nor hemodynamic response', 'Success rate of NGI', 'success rate of NGI in accumulative attempts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C0150683', 'cui_str': 'Nasopharyngeal airway device'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C0150683', 'cui_str': 'Nasopharyngeal airway device'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4509963', 'cui_str': 'Structure of right anterior naris'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",108.0,0.189596,"However, the NPA method proved to take more time than the routine method for NGI successful at the first attempt.
","[{'ForeName': 'Ting-Yang', 'Initials': 'TY', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center, No. 5, Fuxing St., Guishan District, Taoyuan, 33305, Taiwan.'}, {'ForeName': 'Jr-Rung', 'Initials': 'JR', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center, No. 5, Fuxing St., Guishan District, Taoyuan, 33305, Taiwan.'}, {'ForeName': 'Yung-Tai', 'Initials': 'YT', 'LastName': 'Chung', 'Affiliation': 'Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center, No. 5, Fuxing St., Guishan District, Taoyuan, 33305, Taiwan. oj8600chung@gmail.com.'}]",BMC gastroenterology,['10.1186/s12876-020-01514-6']
1898,33143640,"Randomized, placebo-controlled, double-blind, pilot trial to investigate safety and efficacy of Cerebrolysin in patients with aneurysmal subarachnoid hemorrhage.","ASBTRACT
BACKGROUND: There are limited neuroprotective treatment options for patients with aneurysmal subarachnoid hemorrhage (SAH). Cerebrolysin, a brain-specific proposed pleiotropic neuroprotective agent, has been suggested to improve global functional outcomes in ischemic stroke. We investigated the efficacy, safety and feasibility of administering Cerebrolysin for SAH patients.
METHODS
This was a prospective, randomized, double-blind, placebo-controlled, single-center, parallel-group pilot study. Fifty patients received either daily Cerebrolysin (30 ml/day) or a placebo (saline) for 14 days (25 patients per study group). The primary endpoint was a favorable Extended Glasgow Outcome Scale (GOSE) of 5 to 8 (moderate disability to good recovery) at six-months. Secondary endpoints included the modified Ranking Scale (mRS), the Montreal Cognitive Assessment (MOCA) score, occurrence of adverse effects and the occurrence of delayed cerebral ischemia (DCI).
RESULTS
No severe adverse effects or mortality attributable to Cerebrolysin were observed. No significant difference was detected in the proportion of patients with favorable six-month GOSE in either study group (odds ratio (OR): 1.49; 95% confidence interval (CI): 0.43-5.17). Secondary functional outcome measures for favorable six-month recovery i.e. a mRS of 0 to 3 (OR: 3.45; 95% CI 0.79-15.01) were comparable for both groups. Similarly, there was no difference in MOCA neurocognitive performance (p-value: 0.75) and in the incidence of DCI (OR: 0.85 95% CI: 0.28-2.59).
CONCLUSIONS
Use of Cerebrolysin in addition to standard-of-care management of aneurysmal SAH is safe, well tolerated and feasible. However, the neutral results of this trial suggest that it does not improve the six-month global functional performance of patients.
CLINICAL TRIAL REGISTRATION
Name of Registry: ClinicalTrials.gov Trial Registration Number: NCT01787123 . Date of Registration: 8th February 2013.",2020,"Similarly, there was no difference in MOCA neurocognitive performance (p-value: 0.75) and in the incidence of DCI (OR: 0.85 95% CI: 0.28-2.59).
","['SAH patients', 'patients with aneurysmal subarachnoid hemorrhage (SAH', 'patients with aneurysmal subarachnoid hemorrhage', 'Fifty patients received either']","['Cerebrolysin', 'daily Cerebrolysin', 'placebo', 'placebo (saline']","['favorable six-month recovery i.e. a mRS of 0 to 3', 'MOCA neurocognitive performance', 'modified Ranking Scale (mRS), the Montreal Cognitive Assessment (MOCA) score, occurrence of adverse effects and the occurrence of delayed cerebral ischemia (DCI', 'efficacy, safety and feasibility', 'favorable Extended Glasgow Outcome Scale (GOSE) of 5 to 8 (moderate disability to good recovery', 'proportion of patients with favorable six-month GOSE']","[{'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}]","[{'cui': 'C0055108', 'cui_str': 'cerebrolysin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0699794', 'cui_str': 'Rank'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",50.0,0.67788,"Similarly, there was no difference in MOCA neurocognitive performance (p-value: 0.75) and in the incidence of DCI (OR: 0.85 95% CI: 0.28-2.59).
","[{'ForeName': 'Peter Y M', 'Initials': 'PYM', 'LastName': 'Woo', 'Affiliation': 'Department of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China. wym307@ha.org.hk.'}, {'ForeName': 'Joanna W K', 'Initials': 'JWK', 'LastName': 'Ho', 'Affiliation': 'Department of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.'}, {'ForeName': 'Natalie M W', 'Initials': 'NMW', 'LastName': 'Ko', 'Affiliation': 'Department of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.'}, {'ForeName': 'Ronald P T', 'Initials': 'RPT', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Jian', 'Affiliation': 'Department of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.'}, {'ForeName': 'Alberto C H', 'Initials': 'ACH', 'LastName': 'Chu', 'Affiliation': 'Department of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.'}, {'ForeName': 'Marco C L', 'Initials': 'MCL', 'LastName': 'Kwan', 'Affiliation': 'Department of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.'}, {'ForeName': 'Yung', 'Initials': 'Y', 'LastName': 'Chan', 'Affiliation': 'Department of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.'}, {'ForeName': 'Alain K S', 'Initials': 'AKS', 'LastName': 'Wong', 'Affiliation': 'Department of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.'}, {'ForeName': 'Hoi-Tung', 'Initials': 'HT', 'LastName': 'Wong', 'Affiliation': 'Department of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.'}, {'ForeName': 'Kwong-Yau', 'Initials': 'KY', 'LastName': 'Chan', 'Affiliation': 'Department of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.'}, {'ForeName': 'John C K', 'Initials': 'JCK', 'LastName': 'Kwok', 'Affiliation': 'Department of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.'}]",BMC neurology,['10.1186/s12883-020-01908-9']
1899,33143647,Arthroscopic microfracture with atelocollagen augmentation for osteochondral lesion of the talus: a multicenter randomized controlled trial.,"BACKGROUND
We aimed to evaluate whether arthroscopic microfracture with atelocollagen augmentation could improve the clinical outcomes and quality of regenerated cartilage in patients with osteochondral lesion of the talus (OLT). We hypothesized that the clinical outcomes and quality of the regenerated cartilage would be superior in patients undergoing arthroscopic microfracture with atelocollagen augmentation compared to those undergoing arthroscopic microfracture alone.
METHODS
In this multicenter, randomized controlled trial, 60 patients were randomly allocated to two groups: arthroscopic microfracture with atelocollagen augmentation (group 1, n = 31) and arthroscopic microfracture alone (group 2, n = 29). Mean 100-mm visual analog scale (VAS), Hannover scoring system (HSS), and American Orthopedic Foot and Ankle Society (AOFAS) scores were assessed 2 years postoperatively and compared between the groups. The quality of the regenerated cartilage was assessed according to the Magnetic Resonance Observation of CArtilage Repair Tissue (MOCART) score based on magnetic resonance imaging.
RESULTS
Forty-six patients (22 in group 1, 23 in group 2) completed the 2-year follow-up. The quality of the regenerated cartilage assessed based on the MOCART score was significantly superior in group 1 compared to group 2 (64.49 ± 18.27 vs 53.01 ± 12.14, p = 0.018). Clinical outcomes in terms of 100-mm VAS (17.25 ± 20.31 vs 19.37 ± 18.58, p = 0.72), HSS (93.09 ± 13.64 vs 86.09 ± 13.36, p = 0.14), and AOFAS (91.23 ± 8.62 vs 86.91 ± 10.68, p = 0.09) scores were superior in group 1 compared to group 2, but the differences were not statistically significant. Both groups showed significant improvements in clinical outcomes compared with the preoperative values.
CONCLUSION
The quality of the regenerated cartilage was superior after arthroscopic microfracture with atelocollagen augmentation compared to that after microfracture alone in patients with OLT. Clinical outcomes assessed 2 years postoperatively were superior in patients who underwent arthroscopic microfracture with atelocollagen augmentation compared to those who underwent arthroscopic microfracture alone, although the differences were not statistically significant. A long-term study of the cohort is required to confirm these findings.
TRIAL REGISTRATION
ClinicalTrials.gov ( NCT02519881 ), August 11, 2015.",2020,"Clinical outcomes assessed 2 years postoperatively were superior in patients who underwent arthroscopic microfracture with atelocollagen augmentation compared to those who underwent arthroscopic microfracture alone, although the differences were not statistically significant.","['60 patients', 'patients with osteochondral lesion of the talus (OLT', 'patients with OLT', 'patients undergoing arthroscopic microfracture with']","['arthroscopic microfracture with atelocollagen augmentation', 'arthroscopic microfracture alone', 'Arthroscopic microfracture with atelocollagen augmentation', 'atelocollagen augmentation']","['HSS', 'American Orthopedic Foot and Ankle Society (AOFAS) scores', 'clinical outcomes', 'MOCART score', 'quality of the regenerated cartilage', 'Mean 100-mm visual analog scale (VAS), Hannover scoring system (HSS), and', 'AOFAS', 'Magnetic Resonance Observation of CArtilage Repair Tissue (MOCART) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0476169', 'cui_str': 'Osteochondral fracture'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0039277', 'cui_str': 'Bone structure of talus'}, {'cui': 'C1265651', 'cui_str': 'Microfracture'}]","[{'cui': 'C1265651', 'cui_str': 'Microfracture'}, {'cui': 'C0052591', 'cui_str': 'atelocollagen'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1112785', 'cui_str': 'Cartilage repair'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",60.0,0.0772168,"Clinical outcomes assessed 2 years postoperatively were superior in patients who underwent arthroscopic microfracture with atelocollagen augmentation compared to those who underwent arthroscopic microfracture alone, although the differences were not statistically significant.","[{'ForeName': 'Young Koo', 'Initials': 'YK', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, Soonchunhyang University Bucheon Hospital, Bucheon-si, Gyunggi-do, Republic of Korea.'}, {'ForeName': 'Ki Won', 'Initials': 'KW', 'LastName': 'Young', 'Affiliation': 'Department of Foot and Ankle Surgery, Eulji Medical Center, Eulji University, Seoul, Republic of Korea.'}, {'ForeName': 'Jin Su', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Sejong Sports Medicine and Performance Center, Seoul, Republic of Korea.'}, {'ForeName': 'Hong Seop', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Department of Foot and Ankle Surgery, Eulji Medical Center, Eulji University, Seoul, Republic of Korea.'}, {'ForeName': 'Whi-Je', 'Initials': 'WJ', 'LastName': 'Cho', 'Affiliation': 'Department of Orthopedic Surgery, Soonchunhyang University Bucheon Hospital, Bucheon-si, Gyunggi-do, Republic of Korea.'}, {'ForeName': 'Hyong Nyun', 'Initials': 'HN', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, 1, Singil-ro, Yeongdeungpo-gu, Seoul, 07441, Republic of Korea. hyongnyun@naver.com.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03730-3']
1900,33143707,Evaluating the impact of larviciding with Bti and community education and mobilization as supplementary integrated vector management interventions for malaria control in Kenya and Ethiopia.,"BACKGROUND
Malaria prevention in Africa is mainly through the use of long-lasting insecticide treated nets (LLINs). The objective of the study was to assess the effect of supplementing LLINs with either larviciding with Bacillus thuringiensis israelensis (Bti) or community education and mobilization (CEM), or with both interventions in the context of integrated vector management (IVM).
METHODS
The study involved a factorial, cluster-randomized, controlled trial conducted in Malindi and Nyabondo sites in Kenya and Tolay site in Ethiopia, to assess the impact of the following four intervention options on mosquitoes and malaria prevalence: LLINs only (arm 1); LLINs and Bti (arm 2); LLINs and CEM (arm 3); and, LLINs combined with Bti and CEM (arm 4). Between January 2013 and December 2015, CDC light traps were used to sample adult mosquitoes during the second, third and fourth quarter of each year in 10 houses in each of 16 villages at each of the three study sites. Larvae were sampled once a fortnight from potential mosquito-breeding habitats using standard plastic dippers. Cross-sectional malaria parasite prevalence surveys were conducted involving a total of 11,846 primary school children during the 3-year period, including 4800 children in Tolay, 3000 in Malindi and 4046 in Nyabondo study sites.
RESULTS
Baseline relative indoor anopheline density was 0.11, 0.05 and 0.02 mosquitoes per house per night in Malindi, Tolay and Nyabondo sites, respectively. Nyabondo had the highest recorded overall average malaria prevalence among school children at 32.4%, followed by Malindi with 5.7% and Tolay 1.7%. There was no significant reduction in adult anopheline density at each of the three sites, which could be attributed to adding of the supplementary interventions to the usage of LLINs. Malaria prevalence was significantly reduced by 50% in Tolay when using LLINs coupled with application of Bti, community education and mobilization. The two other sites did not reveal significant reduction of prevalence as a result of combining LLINs with any of the other supplementary interventions.
CONCLUSION
Combining LLINs with larviciding with Bti and CEM further reduced malaria infection in a low prevalence setting in Ethiopia, but not at sites with relatively higher prevalence in Kenya. More research is necessary at the selected sites in Kenya to periodically determine the suite of vector control interventions and broader disease management strategies, which when integrated would further reduce adult anopheline populations and malaria prevalence beyond what is achieved with LLINs.",2020,"The two other sites did not reveal significant reduction of prevalence as a result of combining LLINs with any of the other supplementary interventions.
","['Cross-sectional malaria parasite prevalence surveys were conducted involving a total of 11,846 primary school children during the 3-year period, including 4800 children in Tolay, 3000 in Malindi and 4046 in Nyabondo study sites', 'Malindi and Nyabondo sites in Kenya and Tolay site in Ethiopia', 'malaria control in Kenya and Ethiopia', 'Between January 2013 and December 2015, CDC light traps were used to sample adult mosquitoes during the second, third and fourth quarter of each year in 10 houses in each of 16 villages at each of the three study sites']","['larviciding with Bti and community education and mobilization as supplementary integrated vector management interventions', 'supplementing LLINs with either larviciding with Bacillus thuringiensis israelensis (Bti) or community education and mobilization (CEM), or with both interventions in the context of integrated vector management (IVM']","['overall average malaria prevalence', 'indoor anopheline density', 'adult anopheline density', 'Malaria prevalence', 'malaria infection', 'mosquitoes and malaria prevalence: LLINs only (arm 1); LLINs and Bti (arm 2); LLINs and CEM (arm 3); and, LLINs combined with Bti and CEM (arm 4']","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026584', 'cui_str': 'Family Culicidae'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}]","[{'cui': 'C0004597', 'cui_str': 'Bacillus thuringiensis'}, {'cui': 'C0009470', 'cui_str': 'Community education'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0021576', 'cui_str': 'Insecticide'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0449255', 'cui_str': 'Context'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0026584', 'cui_str': 'Family Culicidae'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0021576', 'cui_str': 'Insecticide'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0004597', 'cui_str': 'Bacillus thuringiensis'}, {'cui': 'C0009470', 'cui_str': 'Community education'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]",11846.0,0.0344779,"The two other sites did not reveal significant reduction of prevalence as a result of combining LLINs with any of the other supplementary interventions.
","[{'ForeName': 'Clifford M', 'Initials': 'CM', 'LastName': 'Mutero', 'Affiliation': 'International Centre of Insect Physiology and Ecology (ICIPE), P. O. Box 30772, 00100, Nairobi, Kenya. cmutero@icipe.org.'}, {'ForeName': 'Collins', 'Initials': 'C', 'LastName': 'Okoyo', 'Affiliation': 'Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute (KEMRI), Nairobi, Kenya.'}, {'ForeName': 'Melaku', 'Initials': 'M', 'LastName': 'Girma', 'Affiliation': 'Zoological Sciences Department, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Mwangangi', 'Affiliation': 'Centre for Geographic Medicine Research, Kenya Medical Research Institute (KEMRI), Kilifi, Kenya.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Kibe', 'Affiliation': 'Centre for Geographic Medicine Research, Kenya Medical Research Institute (KEMRI), Kilifi, Kenya.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""Ng'ang'a"", 'Affiliation': 'International Centre of Insect Physiology and Ecology (ICIPE), P. O. Box 30772, 00100, Nairobi, Kenya.'}, {'ForeName': 'Dereje', 'Initials': 'D', 'LastName': 'Kussa', 'Affiliation': 'International Centre of Insect Physiology and Ecology (ICIPE), Addis Ababa, Ethiopia.'}, {'ForeName': 'Gracious', 'Initials': 'G', 'LastName': 'Diiro', 'Affiliation': 'International Centre of Insect Physiology and Ecology (ICIPE), P. O. Box 30772, 00100, Nairobi, Kenya.'}, {'ForeName': 'Hippolyte', 'Initials': 'H', 'LastName': 'Affognon', 'Affiliation': 'West and Central Africa Council for Agricultural Research and Development, Dakar, Senegal.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Mbogo', 'Affiliation': 'Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute (KEMRI), Nairobi, Kenya.'}]",Malaria journal,['10.1186/s12936-020-03464-6']
1901,33143722,"Correction to: Fasting in diabetes treatment (FIT) trial: study protocol for a randomised, controlled, assessor-blinded intervention trial on the effects of intermittent use of a fasting-mimicking diet in patients with type 2 diabetes.",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['patients with type 2 diabetes'],['fasting-mimicking diet'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",[],,0.0466253,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Elske L', 'Initials': 'EL', 'LastName': 'van den Burg', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands. e.l.van_den_burg@lumc.nl.'}, {'ForeName': 'Marjolein P', 'Initials': 'MP', 'LastName': 'Schoonakker', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Petra G', 'Initials': 'PG', 'LastName': 'van Peet', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'M Elske', 'Initials': 'ME', 'LastName': 'van den Akker-van Marle', 'Affiliation': 'Department of Biomedical Data Sciences, Medical Decision Making, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Ko Willems', 'Initials': 'KW', 'LastName': 'van Dijk', 'Affiliation': 'Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Valter D', 'Initials': 'VD', 'LastName': 'Longo', 'Affiliation': 'FIRC Institute of Molecular Oncology, Milan, Italy.'}, {'ForeName': 'Hildo J', 'Initials': 'HJ', 'LastName': 'Lamb', 'Affiliation': 'Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Mattijs E', 'Initials': 'ME', 'LastName': 'Numans', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Pijl', 'Affiliation': 'Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}]",BMC endocrine disorders,['10.1186/s12902-020-00635-z']
1902,33143794,Does providing personalized depression risk information lead to increased psychological distress and functional impairment? Results from a mixed-methods randomized controlled trial.,"BACKGROUND
Multivariable risk algorithms (MVRP) predicting the personal risk of depression will form an important component of personalized preventive interventions. However, it is unknown whether providing personalized depression risk will lead to unintended psychological harms. The objectives of this study were to evaluate the impact of providing personalized depression risk on non-specific psychological distress and functional impairment over 12 months.
METHODS
A mixed-methods randomized controlled trial was conducted in 358 males and 354 females who were at high risk of having a major depressive episode according to sex-specific MVRPs, and who were randomly recruited across Canada. Participants were assessed at baseline, 6 and 12 months.
RESULTS
Over 93% of participants were interested in knowing their depression risk. The intervention group had a greater reduction in K10 score over 12 months than the control group; complete-case analysis found a significant between-group difference in mean K10 change score (d = 1.17, 95% CI 0.12-2.23) at 12 months. Participants in the intervention group also reported significantly less functional impairment in the domains of home and work/school activities, than did those in the control group. A majority of the qualitative interviewees commented that personalized depression risk information does not have a negative impact on physical and mental health.
CONCLUSIONS
This study found no evidence that providing personalized depression risk information will lead to worsening psychological distress, functional impairment, and absenteeism. Provision of personalized depression risk information may have positive impacts on non-specific psychological distress and functioning.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02943876.",2020,"Participants in the intervention group also reported significantly less functional impairment in the domains of home and work/school activities, than did those in the control group.","['358 males and 354 females who were at high risk of having a major depressive episode according to sex-specific MVRPs, and who were randomly recruited across Canada']",[],"['functional impairment in the domains of home and work/school activities', 'mean K10 change score', 'K10 score']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]",[],"[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",358.0,0.225802,"Participants in the intervention group also reported significantly less functional impairment in the domains of home and work/school activities, than did those in the control group.","[{'ForeName': 'JianLi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Mental Health Research, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Eccles', 'Affiliation': 'Institute of Mental Health Research, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Nannarone', 'Affiliation': 'Institute of Mental Health Research, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schmitz', 'Affiliation': 'Douglas Mental Health Research Institute, McGill University, Montreal, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Patten', 'Affiliation': 'Department of Psychiatry, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Lashewicz', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}]",Psychological medicine,['10.1017/S0033291720003955']
1903,33143831,"Effectiveness of Teaching with Visualisation Table in Comparison to Traditional Lecture in Anatomy Department, Jinnah Sindh Medical University.","OBJECTIVES
To determine the effectiveness of Sectra visualisation table (SVT) in a public sector setup and to compare the traditional (TRAD) lecture with SVT-aided teaching in terms of learning outcomes and students' perception regarding SVT.
STUDY DESIGN
Cross-sectional study.
PLACE AND DURATION OF STUDY
Jinnah Sindh Medical University, from October to November 2018.
METHODOLOGY
Entire batch of BDS (Bachelors of Dental Surgery) i.e. 50 students were randomly distributed in TRAD and SVT groups, both were exposed to 3 sessions of 1-hour duration. TRAD group attended lecture sessions; whereas SVT group were exposed to SVT-aided teaching. Test was conducted at the end of each session. To compare the scores, independent sample t test was done. Percentages of feedback of SVT group was obtained on Microsoft excel. VAK questionnaire was used to identify learning styles of SVT group, and its association with their performance was obtained by chi square test.
RESULTS
Scores of MCQs test between the groups showed non-significant difference (p = 0.24). Positive feedback was obtained in favour of SVT. Students of SVT group exposed to visual style of learning performed better.
CONCLUSION
SVT cannot totally replace traditional lecture, although it is a promising tool which can be introduced in the curriculum to enrich the learning experience of students. Key Words: Traditional method, Sectra visualisation table, MCQs test, Feedback, Learning style.",2020,"RESULTS
Scores of MCQs test between the groups showed non-significant difference (p = 0.24).","['i.e. 50 students', 'Bachelors of Dental Surgery']","['TRAD', 'BDS', 'traditional (TRAD) lecture with SVT-aided teaching', 'Sectra visualisation table (SVT', 'SVT', 'Teaching with Visualisation Table']","['Positive feedback', 'visual style of learning performed better', 'Traditional method, Sectra visualisation table, MCQs test, Feedback, Learning style']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0204324', 'cui_str': 'Dental surgical procedure'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C2676137', 'cui_str': 'Diamond-Blackfan Anemia 1'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",50.0,0.0201845,"RESULTS
Scores of MCQs test between the groups showed non-significant difference (p = 0.24).","[{'ForeName': 'Tanzeela', 'Initials': 'T', 'LastName': 'Kausar', 'Affiliation': 'Department of Anatomy, Jinnah Sindh Medical University, Karachi, Pakistan.'}, {'ForeName': 'Sanam', 'Initials': 'S', 'LastName': 'Chandio', 'Affiliation': 'Department of Anatomy, Jinnah Sindh Medical University, Karachi, Pakistan.'}, {'ForeName': 'Iram', 'Initials': 'I', 'LastName': 'Quddus', 'Affiliation': 'Department of Anatomy, Jinnah Sindh Medical University, Karachi, Pakistan.'}, {'ForeName': 'Ghulam Sarwar', 'Initials': 'GS', 'LastName': 'Qureshi', 'Affiliation': 'Department of Anatomy, Jinnah Sindh Medical University, Karachi, Pakistan.'}, {'ForeName': 'Zafar Haleem', 'Initials': 'ZH', 'LastName': 'Baloch', 'Affiliation': 'Department of Anatomy, Jinnah Sindh Medical University, Karachi, Pakistan.'}, {'ForeName': 'Anam', 'Initials': 'A', 'LastName': 'Pario', 'Affiliation': 'Department of Anatomy, Jinnah Sindh Medical University, Karachi, Pakistan.'}]",Journal of the College of Physicians and Surgeons--Pakistan : JCPSP,['10.29271/jcpsp.2020.10.1074']
1904,33143906,Effects of an educational intervention on health-related quality of life among family caregivers of people with dementia with a Turkish or Moroccan immigrant background: Insights from a cluster randomised controlled trial.,"OBJECTIVE
Gaining understanding of the health-related quality of life (HRQL) of family caregivers of people with dementia with Turkish or Moroccan immigrant backgrounds and to examine whether an educational peer group intervention can improve HRQL.
METHODS
Understanding of HRQL and associated variables was obtained by multiple linear regression analyses. The effects of the intervention on HRQL were assessed in multilevel analyses using data collected before the start (baseline), directly after the intervention (one to two weeks after baseline) and three months after the start of the intervention. The intervention (two interactive group sessions) entailed providing information about dementia and care/support options.
RESULTS
At baseline (n = 319), HRQL was moderately and significantly associated with migration background, gender, self-perceived pressure from informal care and the formal and informal support received (p < .05). The intervention had a small effect on emotional wellbeing directly after the intervention (p < .05) and on perceived general health status three months after (p < .05).
CONCLUSION
Culturally sensitive peer group education on dementia and care/support options can to some extent enhance HRQL among family caregivers in the short term.
PRACTICE IMPLICATIONS
The intervention as described in this study is recommended for supporting family caregivers of people with dementia with Turkish or Moroccan backgrounds.",2020,"The intervention had a small effect on emotional wellbeing directly after the intervention (p < .05) and on perceived general health status three months after (p < .05).
","['family caregivers of people with dementia with a Turkish or Moroccan immigrant background', 'family caregivers of people with dementia with Turkish or Moroccan immigrant backgrounds', 'family caregivers of people with dementia with Turkish or Moroccan backgrounds']","['educational intervention', 'educational peer group intervention', 'intervention (two interactive group sessions) entailed providing information about dementia and care/support options']","['migration background, gender, self-perceived pressure from informal care', 'health-related quality of life', 'HRQL', 'emotional wellbeing']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030767', 'cui_str': 'Peer Group'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C3494177', 'cui_str': 'Informal care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",,0.0665988,"The intervention had a small effect on emotional wellbeing directly after the intervention (p < .05) and on perceived general health status three months after (p < .05).
","[{'ForeName': 'Iris van', 'Initials': 'IV', 'LastName': 'der Heide', 'Affiliation': 'Nivel, Netherlands Institute of Health Services Research, P.O. Box 1568, 3500 BN Utrecht, Netherlands. Electronic address: i.vanderheide@nivel.nl.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'van Wezel', 'Affiliation': 'Alzheimer Nederland, Amersfoort, Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Blom', 'Affiliation': 'Alzheimer Nederland, Amersfoort, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Spreeuwenberg', 'Affiliation': 'Nivel, Netherlands Institute of Health Services Research, P.O. Box 1568, 3500 BN Utrecht, Netherlands.'}, {'ForeName': 'Walter L J M', 'Initials': 'WLJM', 'LastName': 'Devillé', 'Affiliation': 'Nivel, Netherlands Institute of Health Services Research, P.O. Box 1568, 3500 BN Utrecht, Netherlands; Faculty of Social and Behavioral Sciences, University of Amsterdam, Amsterdam, Netherlands; Julius Centre for Health Sciences and Primary Care, University Medical Centre, Utrecht, Netherlands.'}, {'ForeName': 'Anneke L', 'Initials': 'AL', 'LastName': 'Francke', 'Affiliation': 'Nivel, Netherlands Institute of Health Services Research, P.O. Box 1568, 3500 BN Utrecht, Netherlands; Department of Public and Occupational Health, Amsterdam Public Health Research Institute, VU University, Amsterdam, Netherlands.'}]",Patient education and counseling,['10.1016/j.pec.2020.10.029']
1905,33143931,Goal-directed hemodynamic therapy versus restrictive normovolemic therapy in major open abdominal surgery: A randomized controlled trial.,"BACKGROUND
The aim of this study was to compare the occurrence of postoperative complications in patients undergoing elective open abdominal surgery and receiving intraoperative goal-directed hemodynamic therapy or restrictive normovolemic therapy.
METHODS
A total of 401 patients were randomized in the goal-directed hemodynamic therapy or restrictive normovolemic therapy groups. A cardiac output monitor was used in all goal-directed hemodynamic therapy patients and was left at the discretion of anesthetists in charge of patients in the restrictive normovolemic therapy group. The primary outcome was a composite morbidity endpoint (30-day mortality and complications grade 2-4 according to Dindo-Clavien classification). Secondary outcomes were the hospital duration of stay, the incidence of pulmonary, cardiovascular, and renal complications up to 30 days after surgery, and midterm survival.
RESULTS
Intraoperatively, the goal-directed hemodynamic therapy group received higher intravenous fluid volumes (mean of 10.8 mL/kg/h and standard deviation of 4.0) compared with the restrictive normovolemic therapy group (mean of 7.2 mL/kg/h and standard deviation of 2.0; P < .001). On the first postoperative day, similar fluid volumes were infused in the 2 groups. The primary outcome occurred in 57.7% of goal-directed hemodynamic therapy and 53.0% of restrictive normovolemic therapy (relative risk, 1.09 [95% confidence interval, 0.91-1.30]), and there was no significant difference between groups for any secondary outcomes.
CONCLUSION
Among patients undergoing major open abdominal surgery, the goal-directed hemodynamic therapy and the restrictive normovolemic therapy were associated with similar incidence of moderate-to-severe postoperative complications and hospital resource use.",2020,"Secondary outcomes were the hospital duration of stay, the incidence of pulmonary, cardiovascular, and renal complications up to 30 days after surgery, and midterm survival.
","['patients undergoing elective open abdominal surgery and receiving', 'patients undergoing major open abdominal surgery', 'major open abdominal surgery', '401 patients']","['hemodynamic therapy or restrictive normovolemic therapy groups', 'hemodynamic therapy versus restrictive normovolemic\xa0therapy', 'restrictive normovolemic therapy', 'intraoperative goal-directed hemodynamic therapy or restrictive normovolemic therapy']","['hospital duration of stay, the incidence of pulmonary, cardiovascular, and renal complications up to 30 days after surgery, and midterm survival', 'intravenous fluid volumes', 'goal-directed hemodynamic therapy', 'composite morbidity endpoint (30-day mortality and complications grade 2-4 according to Dindo-Clavien classification']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]",401.0,0.13612,"Secondary outcomes were the hospital duration of stay, the incidence of pulmonary, cardiovascular, and renal complications up to 30 days after surgery, and midterm survival.
","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Diaper', 'Affiliation': 'Department of Anesthesiology, Pharmacology, Intensive Care, and Emergency Medicine, University Hospital of Geneva, Switzerland.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Schiffer', 'Affiliation': 'Department of Anesthesiology, Pharmacology, Intensive Care, and Emergency Medicine, University Hospital of Geneva, Switzerland; Faculty of Medicine, University of Geneva, Switzerland.'}, {'ForeName': 'Gleicy Keli', 'Initials': 'GK', 'LastName': 'Barcelos', 'Affiliation': 'Department of Anesthesiology, Pharmacology, Intensive Care, and Emergency Medicine, University Hospital of Geneva, Switzerland.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Luise', 'Affiliation': 'Department of Anesthesiology, Pharmacology, Intensive Care, and Emergency Medicine, University Hospital of Geneva, Switzerland.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Schorer', 'Affiliation': 'Department of Anesthesiology, Pharmacology, Intensive Care, and Emergency Medicine, University Hospital of Geneva, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Ellenberger', 'Affiliation': 'Department of Anesthesiology, Pharmacology, Intensive Care, and Emergency Medicine, University Hospital of Geneva, Switzerland; Faculty of Medicine, University of Geneva, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Licker', 'Affiliation': 'Department of Anesthesiology, Pharmacology, Intensive Care, and Emergency Medicine, University Hospital of Geneva, Switzerland; Faculty of Medicine, University of Geneva, Switzerland. Electronic address: marc-joseph.licker@hcuge.ch.'}]",Surgery,['10.1016/j.surg.2020.09.035']
1906,31745223,Tensor decomposition of TMS-induced EEG oscillations reveals data-driven profiles of antiepileptic drug effects.,"Transcranial magnetic stimulation combined with electroencephalography is a powerful tool to probe human cortical excitability. The EEG response to TMS stimulation is altered by drugs active in the brain, with characteristic ""fingerprints"" obtained for drugs of known mechanisms of action. However, the extraction of specific features related to drug effects is not always straightforward as the complex TMS-EEG induced response profile is multi-dimensional. Analytical approaches can rely on a-priori assumptions within each dimension or on the implementation of cluster-based permutations which do not require preselection of specific limits but may be problematic when several experimental conditions are tested. We here propose an alternative data-driven approach based on PARAFAC tensor decomposition, which provides a parsimonious description of the main profiles underlying the multidimensional data. We validated reliability of PARAFAC on TMS-induced oscillations before extracting the features of two common anti-epileptic drugs (levetiracetam and lamotrigine) in an integrated manner. PARAFAC revealed an effect of both drugs, significantly suppressing oscillations in the alpha range in the occipital region. Further, this effect was stronger under the intake of levetiracetam. This study demonstrates, for the first time, that PARAFAC can easily disentangle the effects of subject, drug condition, frequency, time and space in TMS-induced oscillations.",2019,"The EEG response to TMS stimulation is altered by drugs active in the brain, with characteristic ""fingerprints"" obtained for drugs of known mechanisms of action.",[],"['Transcranial magnetic stimulation combined with electroencephalography', 'levetiracetam', 'levetiracetam and lamotrigine', 'PARAFAC']",[],[],"[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}]",[],,0.02392,"The EEG response to TMS stimulation is altered by drugs active in the brain, with characteristic ""fingerprints"" obtained for drugs of known mechanisms of action.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tangwiriyasakul', 'Affiliation': ""Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, London, UK. chayanin.tangwiriyasakul@kcl.ac.uk.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Premoli', 'Affiliation': ""Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, London, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Spyrou', 'Affiliation': 'School of Engineering, Institute for Digital Communications, The University of Edinburgh, Thomas Bayes Rd, Edinburgh, EH9 3FG, UK.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Chin', 'Affiliation': 'Muir Maxwell Epilepsy Centre, Centre for Clinical Brain Sciences and MRC Centre for Reproductive Health, The University of Edinburgh, 20 Sylvan Place, Edinburgh, EH9 1UW, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Escudero', 'Affiliation': 'School of Engineering, Institute for Digital Communications, The University of Edinburgh, Thomas Bayes Rd, Edinburgh, EH9 3FG, UK.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Richardson', 'Affiliation': ""Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, London, UK.""}]",Scientific reports,['10.1038/s41598-019-53565-9']
1907,32327091,The Natural History of Nonculprit Lesions in STEMI: An FFR Substudy of the Compare-Acute Trial.,"OBJECTIVES
The aim of this study was to determine the prognostic value of fractional flow reserve (FFR) in non-infarct-related arteries (IRAs) in ST-segment elevation myocardial infarction (MI).
BACKGROUND
Patients with ST-segment elevation MI often present with multivessel disease. The treatment of non-IRAs is debated. The applicability of FFR has not been widely proved.
METHODS
Outcomes were analyzed in all patients in the Compare-Acute (Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD) trial in whom, after successful primary percutaneous coronary intervention, non-IRAs were interrogated using FFR and treated medically. The treating cardiologist was blinded to the FFR value. The primary endpoint was the composite of cardiovascular mortality, target vessel-related (non-IRA with FFR measurement at primary percutaneous coronary intervention) nonfatal MI, and target vessel revascularization: major adverse cardiac events (MACE) at 24 months.
RESULTS
A total of 751 patients (963 vessels) were included. Target non-IRAs with MACE had lower FFR compared with those without (0.78 vs. 0.84, respectively; p < 0.001). The median FFR of non-IRAs with TVR was lower than that of those without (0.79 vs. 0.85, respectively; p < 0.001). The difference was significant in all vessels. The median FFR of target non-IRAs with MI was lower than that of those without (0.79 vs. 0.84, respectively; p = 0.016). The MACE rate was significantly (p < 0.001) higher in the lowest of FFR tertiles (<0.80) compared with the others (0.80 to 0.87 and ≥0.88).
CONCLUSIONS
In patients with ST-segment elevation MI with multivessel disease, FFR measured in the medically treated non-IRA immediately after successful primary percutaneous coronary intervention shows a nonlinear and inverse risk continuum of MACE. Importantly, worsening prognosis is demonstrated around the cutoff of 0.80.",2020,"The MACE rate was significantly (p < 0.001) higher in the lowest of FFR tertiles (<0.80) compared with the others (0.80 to 0.87 and ≥0.88).
","['751 patients (963 vessels) were included', 'Outcomes were analyzed in all patients in the Compare-Acute (Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD) trial in whom, after successful primary percutaneous coronary intervention, non-IRAs were interrogated using FFR and treated medically', 'Patients with ST-segment elevation MI often present with multivessel disease']","['fractional flow reserve (FFR', 'MACE', 'STEMI']","['FFR', 'composite of cardiovascular mortality, target vessel-related (non-IRA with FFR measurement at primary percutaneous coronary intervention) nonfatal MI, and target vessel revascularization: major adverse cardiac events (MACE', 'median FFR of target non-IRAs with MI', 'FFR tertiles', 'median FFR of non-IRAs with TVR', 'MACE rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]",751.0,0.0460472,"The MACE rate was significantly (p < 0.001) higher in the lowest of FFR tertiles (<0.80) compared with the others (0.80 to 0.87 and ≥0.88).
","[{'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Piróth', 'Affiliation': 'Hungarian Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Bianca M', 'Initials': 'BM', 'LastName': 'Boxma-de Klerk', 'Affiliation': 'Department of Cardiology, Maasstad Ziekenhuis, Rotterdam, the Netherlands; Franciscus Gasthuis & Vlietland, Department of Statistics and Education, Franciscus Academy, Rotterdam, the Netherlands.'}, {'ForeName': 'Elmir', 'Initials': 'E', 'LastName': 'Omerovic', 'Affiliation': 'Department of Cardiology, Gothenburg University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Andréka', 'Affiliation': 'Hungarian Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Géza', 'Initials': 'G', 'LastName': 'Fontos', 'Affiliation': 'Hungarian Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Fülöp', 'Affiliation': 'Hungarian Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': 'Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Department of Cardiology, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': 'Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abdelghani', 'Affiliation': 'Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.'}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Department of Cardiology, Maasstad Ziekenhuis, Rotterdam, the Netherlands. Electronic address: smitsp@maasstadziekenhuis.nl.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.02.015']
1908,33150715,Nitrates in combination with hydralazine in cardiorenal syndrome: a randomized controlled proof-of-concept study.,"AIMS
Cardiorenal syndrome (CRS) is a common problem of great morbidity and mortality. Hydralazine-isosorbide dinitrate (H-ISDN) may be used in renal failure and may improve exercise capacity in heart failure (HF). Our proof-of-concept study aimed to evaluate early evidence of efficacy, safety, and feasibility of H-ISDN compared with standard of care in CRS.
METHODS AND RESULTS
This multi-centre, single-blind, randomized trial in Singapore enrolled CRS patients, defined as chronic HF with concomitant renal failure [estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m 2 ]. The primary outcome was 6 min walk test (6MWT) distance measured at 6 months. Secondary outcomes included study feasibility; efficacy outcomes which included renal, cardiac, and endothelial functions, health-related quality of life using Short Form-36, clinical outcomes; and adverse events. Forty-four patients [71 ± 10 years; 75% male; median (inter-quartile range) N-terminal prohormone brain natriuretic peptide 1346 (481-2272) pg/mL] with CRS (left ventricular ejection fraction 42 ± 12% and eGFR 46 ± 15 ml/min/1.73 m 2 ) were randomized into two equal groups. Of these, 39 (89%) had hypertension, 27 (61%) had diabetes mellitus, and 17 (39%) had atrial fibrillation. Six (27%) discontinued H-ISDN owing to intolerance and poor compliance. There was a trend towards improved 6MWT distance with H-ISDN compared with standard of care at 6 months (mean difference 27 m; 95% CI, -12 to 66), with little differences in secondary efficacy outcomes. Giddiness and hypotension occurred more frequently with H-ISDN, but HF hospitalizations and mortality were less.
CONCLUSIONS
Our pilot study does not support the addition of H-ISDN on top of standard medical therapy to improve exercise capacity in patients with CRS.",2020,"There was a trend towards improved 6MWT distance with H-ISDN compared with standard of care at 6 months (mean difference 27 m; 95% CI, -12 to 66), with little differences in secondary efficacy outcomes.","['cardiorenal syndrome', 'Forty-four patients [71\xa0±\xa010\xa0years; 75% male; median (inter-quartile range) N-terminal prohormone brain natriuretic peptide 1346 (481-2272)\xa0pg', 'patients with CRS', 'Singapore enrolled CRS patients, defined as chronic HF with concomitant renal failure [estimated glomerular filtration rate (eGFR']","['CRS', 'Hydralazine-isosorbide dinitrate (H-ISDN', 'H-ISDN', 'hydralazine']","['6MWT distance', 'atrial fibrillation', 'study feasibility; efficacy outcomes which included renal, cardiac, and endothelial functions, health-related quality of life using Short Form-36, clinical outcomes; and adverse events', 'diabetes mellitus', '6\xa0min walk test (6MWT) distance', 'exercise capacity', 'Giddiness and hypotension', 'HF hospitalizations and mortality']","[{'cui': 'C2242703', 'cui_str': 'Cardiorenal syndrome'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C2242501', 'cui_str': 'N-terminal prohormone brain natriuretic peptide'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C2242703', 'cui_str': 'Cardiorenal syndrome'}, {'cui': 'C1628973', 'cui_str': 'Hydralazine / Isosorbide Dinitrate'}, {'cui': 'C0020223', 'cui_str': 'Hydralazine'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0476206', 'cui_str': 'Dizziness and giddiness'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.36978,"There was a trend towards improved 6MWT distance with H-ISDN compared with standard of care at 6 months (mean difference 27 m; 95% CI, -12 to 66), with little differences in secondary efficacy outcomes.","[{'ForeName': 'Shir Lynn', 'Initials': 'SL', 'LastName': 'Lim', 'Affiliation': 'Department of Cardiology, National University Heart Center, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'Singapore Clinical Research Institute, Singapore.'}, {'ForeName': 'Kai Lee', 'Initials': 'KL', 'LastName': 'Woo', 'Affiliation': 'Department of Cardiology, National University Heart Center, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Horng Ruey', 'Initials': 'HR', 'LastName': 'Chua', 'Affiliation': 'Division of Nephrology, National University Hospital, Singapore.'}, {'ForeName': 'Yoke Ching', 'Initials': 'YC', 'LastName': 'Lim', 'Affiliation': 'Department of Cardiology, National University Heart Center, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'David K L', 'Initials': 'DKL', 'LastName': 'Sim', 'Affiliation': 'Department of Cardiology, National Heart Center, Singapore.'}, {'ForeName': 'Sheldon S G', 'Initials': 'SSG', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, Changi General Hospital, Singapore.'}, {'ForeName': 'Yee Leong', 'Initials': 'YL', 'LastName': 'Teoh', 'Affiliation': 'Singapore Clinical Research Institute, Singapore.'}, {'ForeName': 'Arthur Mark', 'Initials': 'AM', 'LastName': 'Richards', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, Singapore.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'Duke-NUS Medical School, Singapore.'}]",ESC heart failure,['10.1002/ehf2.13076']
1909,33150727,Homemade valved holding chambers for children with airway hyperresponsiveness: A randomized crossover trial.,"BACKGROUND
During the COVID-19 pandemic, a metered-dose inhaler (MDI) with a valved holding chamber (VHC) is a preferred route of bronchodilator delivery. We have developed a new homemade VHC, made of a paper coffee cup, and a drinking water bottle. This study was conducted to compare the bronchodilator response in children with airway hyperresponsiveness after the use of our homemade VHC and that of a standard commercial one.
METHODS
In a randomized, two-period, two-sequence crossover trial, we recruited 20 children, aged 6-15 years, who had a greater than 12% increase in FEV 1 after inhaled salbutamol. They were randomized into Group A and B. Group A used our VHC on the first day and Aerochamber® on the second day. Group B used the same VHCs but in alternate sequence. Spirometries were performed before and after 400 µg of salbutamol, MDI was administered via those VHCs.
RESULTS
Baseline demographic data and spirometric values did not have statistically significant differences between group A and B and between the first and second day (p > .05). After giving salbutamol MDI, both VHCs produced significant increases in FVC, FEV 1 , and FEF 25-75% (p < .005). The improvement in FEV 1 did not significantly differ between our homemade VHC and Aerochamber® (p > .05).
CONCLUSION
Our homemade VHC is effective for an MDI bronchodilator delivery. Since it is very cheap and easy to make, it may be used as a disposable device to minimize airborne transmission especially when commercial VHC is not available.",2020,"The improvement in FEV 1 did not significantly differ between our homemade VHC and Aerochamber® (p > .05).
","['hyperresponsiveness', 'children with airway hyperresponsiveness after the use of our homemade VHC and that of a standard commercial one', 'children with airway', '20 children, aged 6-15 years, who had a greater than 12% increase in FEV 1 after inhaled']","['salbutamol, MDI was administered via those VHCs', 'salbutamol', 'valved holding chamber (VHC']","['FEV', 'FVC, FEV 1 , and FEF']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C2350030', 'cui_str': 'Valved Holding Chambers'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C2350030', 'cui_str': 'Valved Holding Chambers'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}]","[{'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]",20.0,0.0469285,"The improvement in FEV 1 did not significantly differ between our homemade VHC and Aerochamber® (p > .05).
","[{'ForeName': 'Kesanee', 'Initials': 'K', 'LastName': 'Chaicoming', 'Affiliation': 'Nursing Affairs, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Aroonwan', 'Initials': 'A', 'LastName': 'Preutthipan', 'Affiliation': 'Division of Pediatric Pulmonology, Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Anusorn', 'Initials': 'A', 'LastName': 'Adirekkittikun', 'Affiliation': 'Division of Pediatric Pulmonology, Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Malinee', 'Initials': 'M', 'LastName': 'Nugboon', 'Affiliation': 'Nursing Affairs, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Pediatric pulmonology,['10.1002/ppul.25123']
1910,33150732,A Neuroimaging Preparation Protocol Tailored for Autism.,"This paper describes the key basic elements required for a successful multi-parametric MRI data acquisition in awake children with autism. The procedure was designed by taking into account methodological challenges arising from the acquisition of Resting State fMRI (RS fMRI) data, and factors such as cost, time, and staff availability. The ultimate aim was to prepare an imaging preparation protocol with high transferability to the whole autism spectrum, adaptable for use in a multi-site research with multiple time points. As part of a randomized pharmaco-intervention study, 31 children aged 4-10 years with Neurofibromatosis 1 and autism underwent MR imaging at baseline and end of intervention. The protocol consisted of tailored habituation instructions including gradual exposure to scanner noise, a social stories booklet, positive incentive strategies, and Play Therapy support. Success rate for initial acquisition was 71% for GABA+ MR spectroscopy at either location, 87% for perfusion, and 67% for diffusion assessment, and 71% for RS fMRI. Qualitative data indicated that 84% parents found the habituation protocol helpful. LAY SUMMARY: Here we describe a protocol for brain Magnetic Resonance Imaging (MRI) tailored for children with ASD to help reduce stress and avoid sedation during scanning. This procedure can make advanced medical imaging more accessible and promote a better MRI experience for families of children with ASD.",2020,"Success rate for initial acquisition was 71% for GABA+ MR spectroscopy at either location, 87% for perfusion, and 67% for diffusion assessment, and 71% for RS fMRI.","['awake children with autism', 'families of children with ASD', '31 children aged 4-10\u2009years with Neurofibromatosis 1 and autism underwent MR imaging at baseline and end of intervention', 'children with ASD', 'Autism']","['tailored habituation instructions including gradual exposure to scanner noise, a social stories booklet, positive incentive strategies, and Play Therapy support', 'brain Magnetic Resonance Imaging (MRI']",['habituation protocol helpful'],"[{'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0032216', 'cui_str': 'Play therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",31.0,0.0499369,"Success rate for initial acquisition was 71% for GABA+ MR spectroscopy at either location, 87% for perfusion, and 67% for diffusion assessment, and 71% for RS fMRI.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tziraki', 'Affiliation': 'Psychology Department, CITY College, International Faculty of the University of Sheffield, Thessaloniki, Greece.'}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Division of Neuroscience & Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Harrison', 'Affiliation': ""NIHR Clinical Research Facility, Royal Manchester Children's Hospital, Manchester University NHS Foundation Trust, Manchester, UK.""}, {'ForeName': 'Neville B', 'Initials': 'NB', 'LastName': 'Wright', 'Affiliation': ""Royal Manchester Children's Hospital, Manchester University NHS Foundation Trust, Manchester, UK.""}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hawkes', 'Affiliation': ""Royal Manchester Children's Hospital, Manchester University NHS Foundation Trust, Manchester, UK.""}, {'ForeName': 'Kapasi', 'Initials': 'K', 'LastName': 'Akhtar', 'Affiliation': 'Division of Neuroscience & Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Division of Neuroscience & Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Stivaros', 'Affiliation': ""Royal Manchester Children's Hospital, Manchester University NHS Foundation Trust, Manchester, UK.""}]",Autism research : official journal of the International Society for Autism Research,['10.1002/aur.2427']
1911,33150743,Effect of Obesogenic Medication on Weight- and Fitness-Change Outcomes: Evidence from the Look AHEAD Study.,"OBJECTIVE
This study evaluates whether obesogenic medications may decrease the effectiveness of lifestyle interventions. The authors of this study hypothesized that participants who took obesogenic medications would be less responsive to the intervention in the Look AHEAD trial.
METHODS
In the trial, 5,145 participants with overweight or obesity, aged 45 to 76 years with type 2 diabetes, were randomly assigned to an intervention (vs. support and education). In this analysis, the association of exposure to obesogenic medications and successful weight loss (≥5% and ≥10% of total weight) and fitness gain (≥1 and ≥2 metabolic equivalents) was examined. For each outcome, multiple logistic regression models were fitted.
RESULTS
Analytic sample sizes were 4,496 for weight-change analyses and 4,051 for fitness-change analyses. After adjusting for covariates, exposure to one or more obesogenic medications significantly decreased the odds of achieving ≥5% weight loss by 32% (odds ratio [OR] 0.68) and achieving ≥10% weight loss by 19% (OR 0.81). The association was dose-dependent-participants using two or more medications were less likely to achieve weight loss than those using one medication. Obesogenic medication exposure was not associated with decreased odds of achieving fitness gain overall.
CONCLUSIONS
The results suggest that exposure to obesogenic medications could hinder successful weight loss in a lifestyle intervention for people with diabetes.",2020,"Obesogenic medication exposure was not associated with decreased odds of achieving fitness gain overall.
","['5,145 participants with overweight or obesity, aged 45 to 76 years with type 2 diabetes', 'participants who took obesogenic medications', 'people with diabetes']",['Obesogenic Medication'],"['weight loss', 'successful weight loss', 'fitness gain (≥1 and ≥2 metabolic equivalents']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}]",5145.0,0.0240692,"Obesogenic medication exposure was not associated with decreased odds of achieving fitness gain overall.
","[{'ForeName': 'Rena C', 'Initials': 'RC', 'LastName': 'Moon', 'Affiliation': 'Department of Bariatric Surgery, Orlando Regional Medical Center, Orlando, Florida, USA.'}, {'ForeName': 'Zakaria', 'Initials': 'Z', 'LastName': 'Almuwaqqat', 'Affiliation': 'Division of Cardiology, Department of Medicine, Emory School of Medicine, Atlanta, Georgia, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22997']
1912,33150850,Incentivizing physical activity through activity monitoring interventions in PAD - a pilot study.,"Background : There is ample evidence to show that supervised exercise is efficacious and cost effective for improving claudication symptoms in patients with peripheral artery disease (PAD). Home based exercise therapy can be an effective alternative to supervised exercise however, the results of this is variable depending on the level of motivation and engagement of the patient. Patients and methods : We performed a pilot study in 41 patients to determine whether a home based exercise program with the use of an activity tracking device with personalized feedback and financial incentives can increase daily activity, improve walking and sustain engagement in the exercise regimen in patients with PAD. In this randomized pilot study, the patients in the study group were fitted with an activity monitoring device and given behavioral monitoring, motivational updates and feedback regarding their exercise program. This study group was further divided in to two groups. One half of these patients in the study group were also given financial incentives if they reached their set targets. The control group wore the device with no feedback or ability to see their number of steps walked. Results : Results showed that at the end of the 12 week period, patients in the study groups walked more compared to the controls and the financial incentive structure resulted in an additional 38-63% increase in average daily steps. Conclusions : This pilot study revealed that a home-based exercise program with activity monitoring, feedback and financial incentives resulted increased daily steps, 6-minute walking distance and overall compliance with the program in PAD patients with claudication.",2020,"Results showed that at the end of the 12 week period, patients in the study groups walked more compared to the controls and the financial incentive structure resulted in an additional 38-63% increase in average daily steps. ","['patients with PAD', '41 patients', 'PAD patients with claudication', 'patients with peripheral artery disease (PAD']","['control group wore the device with no feedback or ability to see their number of steps walked', 'activity monitoring device and given behavioral monitoring, motivational updates and feedback regarding their exercise program', 'supervised exercise', 'activity tracking device with personalized feedback and financial incentives', 'Home based exercise therapy', 'home-based exercise program with activity monitoring, feedback and financial incentives']","['average daily steps', 'financial incentive structure', 'daily activity, improve walking and sustain engagement', 'daily steps, 6-minute walking distance and overall compliance', 'claudication symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3874371', 'cui_str': 'Ability to see'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",41.0,0.0235003,"Results showed that at the end of the 12 week period, patients in the study groups walked more compared to the controls and the financial incentive structure resulted in an additional 38-63% increase in average daily steps. ","[{'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Fukaya', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Welden', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Abdallah', 'Initials': 'A', 'LastName': 'Bukari', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Zeeshan', 'Initials': 'Z', 'LastName': 'Khan', 'Affiliation': 'Rowan University, Glassboro, NJ, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Leeper', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Emile', 'Initials': 'E', 'LastName': 'Mohler', 'Affiliation': ''}]",VASA. Zeitschrift fur Gefasskrankheiten,['10.1024/0301-1526/a000924']
1913,33151042,Oral Administration and Intralesional Injection of Hyaluronic Acid Versus Intralesional Injection Alone in Peyronie's Disease: Results from a Phase III Study.,"PURPOSE
The aim of this study was to compare the effect of combined oral administration and intralesional injection of hyaluronic acid (HA) with intralesional injections alone, in patients with early onset of Peyronie's disease (PD).
MATERIALS AND METHODS
For this prospective, randomized phase III clinical trial we included patients with recent diagnosis of PD. Eighty-one patients were randomized into two groups. Group A consisted of 41 patients receiving oral administration of HA in combination with weekly intralesional injection of HA for 6 weeks. Group B consisted of 40 patients group B who received weekly intralesional injections of HA for 6 weeks, only. The main outcome measures were the changes from baseline to the end of therapy after three months in penile curvature (°) and changes in the international index of erectile function (IIEF-5) score and patient's global impressions of improvement (PGI-I) score.
RESULTS
Group A had a significantly larger reduction in penile curvature as compared with group B (Group A: -7.8°, Group B: -4.1° [p<0.001]). Group A also showed a higher improvement in IIEF-5 and PGI-I scores in comparison with Group B (Group A: +4 IIEF-5, Group B: +2 IIEF-5 [p<0.001]; Group A: 3 PGI-I, Group B: 1 PGI-I, [p<0.001]). At three months both groups had a significant reduction of penile curvature from baseline (p<0.001).
CONCLUSIONS
Oral administration combined with intralesional treatment with HA shows greater efficacy to improve penile curvature and overall sexual satisfaction in comparison with intralesional HA treatment alone.",2020,"Group A also showed a higher improvement in IIEF-5 and PGI-I scores in comparison with Group B (Group A: +4 IIEF-5, Group B: +2 IIEF-5 [p<0.001];","['41 patients receiving', 'patients with recent diagnosis of PD', 'Eighty-one patients', ""patients with early onset of Peyronie's disease (PD"", ""Peyronie's Disease""]","['Hyaluronic Acid Versus Intralesional Injection Alone', 'intralesional injections of HA', 'combined oral administration and intralesional injection of hyaluronic acid (HA', 'oral administration of HA in combination with weekly intralesional injection of HA']","[""penile curvature (°) and changes in the international index of erectile function (IIEF-5) score and patient's global impressions of improvement (PGI-I) score"", 'IIEF-5 and PGI-I scores', 'penile curvature', 'penile curvature and overall sexual satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030848', 'cui_str': 'Induratio penis plastica'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021490', 'cui_str': 'Intralesional injection'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C2938970', 'cui_str': 'Penile curvature'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement'}, {'cui': 'C4706354', 'cui_str': 'Patient Global Impression of Improvement score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}]",81.0,0.0745041,"Group A also showed a higher improvement in IIEF-5 and PGI-I scores in comparison with Group B (Group A: +4 IIEF-5, Group B: +2 IIEF-5 [p<0.001];","[{'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Cai', 'Affiliation': 'Department of Urology, Santa Chiara Regional Hospital, Trento, Italy. ktommy@libero.it.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Tiscione', 'Affiliation': 'Department of Urology, Santa Chiara Regional Hospital, Trento, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Favilla', 'Affiliation': 'Department of Urology, University of Catania, Catania, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Puglisi', 'Affiliation': 'Department of Urology, Santa Chiara Regional Hospital, Trento, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Palumbo', 'Affiliation': 'Department of Urology, San Giacomo Hospital, Monopoli, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Zucchi', 'Affiliation': 'Department of Urology, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Malossini', 'Affiliation': 'Department of Urology, Santa Chiara Regional Hospital, Trento, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Palmieri', 'Affiliation': 'Department of Urology, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Truls E', 'Initials': 'TE', 'LastName': 'Bjerklund Johansen', 'Affiliation': 'Department of Urology, Oslo University Hospital, Oslo, Norway.'}]",The world journal of men's health,['10.5534/wjmh.200048']
1914,33151048,"Oral Testofen, L-Citrulline, Resveratrol, and Caffeine Supplement Drink Improves Sexual Function in Men with Phosphodiesterase 5 Inhibitors: Randomized, Double-Blind, Placebo-Controlled Crossover Pilot Study.","PURPOSE
Sexuality is very important for men's health. Currently, phosphodiesterase type 5 inhibitors (PDE5i) remain the first-line therapy for erectile dysfunction, and no other oral drugs or drinks are approved and used clinically to treat male libido or orgasm dysfunction. In reference to a pharmaceutical dosage document, growing health consciousness is said to have boosted yearly sales of supplement drinks to more than 170 billion yen (1.58 billion US dollars) in Japan. We have created a supplement drink comprised of testofen, L-citrulline, resveratrol, and caffeine. We hypothesized that our supplement drink would be effective for men with sexual dysfunction, and especially libido dysfunction.
MATERIALS AND METHODS
In this study, men with sexual dysfunction received a placebo drink for 14 days or our supplement drink (testofen, 600 mg/d; L-citrulline, 800 mg/d; resveratrol, 300 mg/d; and caffeine, 40 mg/d) for another 14 days separated by a 7-day washout period. Patients continued on-demand use of PDE5i. The International Index of Erectile Function (IIEF) score and adverse events were assessed.
RESULTS
Twenty patients aged 30-47 years old were enrolled in and concluded the study with no adverse events experienced. The IIEF domains of desire frequency, erection frequency, erection firmness, erection confidence, intercourse satisfaction, ejaculation frequency, orgasm frequency, and overall satisfaction were significantly improved with our supplement drink.
CONCLUSIONS
This is the first study to show that our supplement drink may not only be effective for erection but also for libido, orgasm, and ejaculation.",2020,"The IIEF domains of desire frequency, erection frequency, erection firmness, erection confidence, intercourse satisfaction, ejaculation frequency, orgasm frequency, and overall satisfaction were significantly improved with our supplement drink.
","['men with sexual dysfunction', ""men's health"", 'Men with Phosphodiesterase 5 Inhibitors', 'men with sexual dysfunction, and especially libido dysfunction', 'Twenty patients aged 30-47 years old']","['PDE5i', 'caffeine', 'Oral Testofen, L-Citrulline, Resveratrol, and Caffeine Supplement Drink', 'placebo drink for 14 days or our supplement drink (testofen, 600 mg/d; L-citrulline', 'Placebo']","['IIEF domains of desire frequency, erection frequency, erection firmness, erection confidence, intercourse satisfaction, ejaculation frequency, orgasm frequency, and overall satisfaction', 'Sexual Function', 'International Index of Erectile Function (IIEF) score and adverse events']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C1456606', 'cui_str': ""Men's Health""}, {'cui': 'C1318700', 'cui_str': 'Phosphodiesterase 5 inhibitor'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C1318700', 'cui_str': 'Phosphodiesterase 5 inhibitor'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0429830', 'cui_str': 'Erection frequency'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",20.0,0.0594092,"The IIEF domains of desire frequency, erection frequency, erection firmness, erection confidence, intercourse satisfaction, ejaculation frequency, orgasm frequency, and overall satisfaction were significantly improved with our supplement drink.
","[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Shirai', 'Affiliation': 'Department of Urology, Juntendo University Urayasu Hospital, Chiba, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Urology, Juntendo University Urayasu Hospital, Chiba, Japan.'}, {'ForeName': 'Taiki', 'Initials': 'T', 'LastName': 'Ogasa', 'Affiliation': 'Department of Urology, Juntendo University Urayasu Hospital, Chiba, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Urology, Juntendo University Urayasu Hospital, Chiba, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Urology, Juntendo University Urayasu Hospital, Chiba, Japan.'}, {'ForeName': 'Ippei', 'Initials': 'I', 'LastName': 'Hiramatsu', 'Affiliation': 'Department of Urology, Juntendo University Urayasu Hospital, Chiba, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Uesaka', 'Affiliation': 'Department of Urology, Juntendo University Urayasu Hospital, Chiba, Japan.'}, {'ForeName': 'Taiji', 'Initials': 'T', 'LastName': 'Nozaki', 'Affiliation': 'Department of Urology, Juntendo University Urayasu Hospital, Chiba, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Koyama', 'Affiliation': ""D Clinic Tokyo Men's, Tokyo, Japan.""}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tsujimura', 'Affiliation': 'Department of Urology, Juntendo University Urayasu Hospital, Chiba, Japan. atsujimu@juntendo.ac.jp.'}]",The world journal of men's health,['10.5534/wjmh.200129']
1915,33151132,Evaluation of modulatory effects of saffron ( Crocus sativus L.) aqueous extract on oxidative stress in ischemic stroke patients: a randomized clinical trial.,"OBJECTIVES
Saffron ( Crocus sativus L. ) has been widely used in traditional medicine as a treatment of nervous disorders. Saffron as an antioxidant can be considered effective for treatment of oxidative stress in ischemia stroke. Therefore, the aim of the present study was to investigate the role of aqueous extract of saffron in reducing oxidative stress in ischemic strokes patients.
METHODS
Forty patients with acute ischemic stroke were randomly divided into two groups including control group and saffron group. During 4 days of experiment, control group received routine stroke care and saffron group received routine care plus capsule of saffron 400 mg/day (200 mg twice per day). Then, two groups were compared using the National Institute of Health Stoke Scale (NIHSS) and serum oxidative stress biomarkers, at the time of hospital admission and 4 days later as well.
RESULTS
On the fourth day after ischemic stroke onset, antioxidant enzymes activities and glutathione (GSH) and total antioxidant capacity (TAC) levels were higher in the saffron group compared to the control group, while malondialdehyde (MDA) level was lower. In addition, the severity of stroke, based on the NIHSS scores, was significantly reduced after 4 days in the saffron group. The severity of stroke was negatively correlated with the levels of GSH and TAC and positively correlated with MDA level.
CONCLUSIONS
Saffron has modulatory effects on ischemic-induced oxidative stress due to its free radical scavenging and antioxidant properties. Thus, saffron extract can be considered as a potential candidate therapy of the ischemic brain.",2020,"On the fourth day after ischemic stroke onset, antioxidant enzymes activities and glutathione (GSH) and total antioxidant capacity","['ischemic strokes patients', 'Forty patients with acute ischemic stroke', 'ischemic stroke patients']","['routine stroke care and saffron group received routine care plus capsule of saffron 400 mg/day', 'saffron ( Crocus sativus L.) aqueous extract', 'control group and saffron group', 'aqueous extract of saffron']","['TAC) levels', 'levels of GSH and TAC', 'oxidative stress', 'National Institute of Health Stoke Scale (NIHSS) and serum oxidative stress biomarkers', 'malondialdehyde (MDA) level', 'severity of stroke, based on the NIHSS scores', 'severity of stroke', 'antioxidant enzymes activities and glutathione (GSH) and total antioxidant capacity']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0946614', 'cui_str': 'Saffron Crocus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}]",40.0,0.0254524,"On the fourth day after ischemic stroke onset, antioxidant enzymes activities and glutathione (GSH) and total antioxidant capacity","[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Gudarzi', 'Affiliation': 'Faculty of Medicine, Department of Biochemistry, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahvash', 'Initials': 'M', 'LastName': 'Jafari', 'Affiliation': 'Faculty of Medicine, Department of Biochemistry, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Gila', 'Initials': 'G', 'LastName': 'Pirzad Jahromi', 'Affiliation': 'Neuroscience Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Eshrati', 'Affiliation': 'Faculty of Medicine, Department of Biochemistry, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Asadollahi', 'Affiliation': 'Neurology, Electrophysiology Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Nikdokht', 'Affiliation': 'Department of Neurology, Shahid Beheshti University of Medical Science, Tehran, Iran.'}]",Nutritional neuroscience,['10.1080/1028415X.2020.1840118']
1916,33151350,Perceptual amplification following sustained attention: implications for hypervigilance.,"It is known that attending to a cutaneous stimulus briefly increases its subjective intensity. The purpose of the present study was to determine whether an extended period of attention would produce a longer-lasting perceptual amplification. Eighty subjects were assigned alternately to experimental and control groups. Members of the two groups received identical series of tactile stimuli (near-threshold von Frey filaments applied to the forearm), but those in the experimental group carried out a two-interval forced-choice detection task that required attention to the filaments, while subjects in the control group attended instead to a video game. After this initial phase, all subjects gave magnitude estimates of the intensity of a wide range of von Frey filaments. The experimental group gave estimates 42% greater than those of the control group, both for filaments used in the initial phase, and others not presented previously; the perceptual amplification did not, however, transfer to a different type of pressure stimulus, a 5 mm-diameter rod applied to the skin. The aftereffect of sustained attention lasted for at least 15 min. This phenomenon, demonstrated in normal subjects, may have implications for the hypervigilance of some chronic pain patients, which is characterized by both heightened attention to pain and long-lasting perceptual amplification of noxious stimuli.",2020,"The experimental group gave estimates 42% greater than those of the control group, both for filaments used in the initial phase, and others not presented previously; the perceptual amplification did not, however, transfer to a different type of pressure stimulus, a 5 mm-diameter rod applied to the skin.","['Eighty subjects', 'normal subjects']","['tactile stimuli (near-threshold von Frey filaments applied to the forearm), but those in the experimental group carried out a two-interval forced-choice detection task that required attention to the filaments, while subjects in the control group attended instead to a video game']",[],"[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0162473', 'cui_str': 'Auriculotemporal syndrome'}, {'cui': 'C0010851', 'cui_str': 'Cytoskeletal Filaments'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}]",[],80.0,0.0141772,"The experimental group gave estimates 42% greater than those of the control group, both for filaments used in the initial phase, and others not presented previously; the perceptual amplification did not, however, transfer to a different type of pressure stimulus, a 5 mm-diameter rod applied to the skin.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hollins', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA. mhollins@email.unc.edu.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Athans', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.'}]",Experimental brain research,['10.1007/s00221-020-05910-y']
1917,33151364,No significant clinical and radiological differences between fixed versus mobile bearing total knee replacement using the same semi-constrained implant type: a randomized controlled trial with mean 10 years follow-up.,"PURPOSE
The aim of this study was to compare the long-term clinical and radiological results between fixed (FB) and mobile bearing (MB) implants with identical design from the same manufacturer.
METHODS
From March 2007 to May 2009, we recruited 160 patients in a prospective, single centered, randomized controlled trial. The authors compared 81 FB total knee arthroplasty (TKA) versus 79 MB with medial compartment osteoarthritis. The same posterior stabilized HLS Noetos knee prosthesis (CORIN) was used in all patients. The two groups only differed by the tibial insert (fixed or mobile). The authors compared the postoperative Knee Society Score (KSS), the passive clinical and active radiological knee flexion, the implant survivorship, the complications, and the presence of radiolucent lines.
RESULTS
At mean 10.5 years' follow-up (range 8-12.1 years) no significant differences were found in clinical scores (KSS (p = 0.54), pain score (p = 0.77), stair climbing (p = 0.44), passive maximum flexion (p = 0.5)) or for radiological analyses (maximum active radiological flexion (p = 0.06), presence of progressive radiolucent lines (5 (MB group) versus 6 (FB group); p = 0.75)) between groups. No significant difference was found in overall implant survivorship (82% (MB group) versus 78% (FB group) p = 0.58) or complication rate (p = 0.32) at the last follow-up.
CONCLUSION
No significant clinical and radiological differences were found between fixed and mobile bearing TKA using the same semi-constrained implant type with comparable overall survivorship. The choice between a fixed or mobile bearing implant should be based on surgeon preference and experience with the selected implant.
LEVEL OF EVIDENCE
Prospective randomized controlled trial, Level II.",2020,No significant clinical and radiological differences were found between fixed and mobile bearing TKA using the same semi-constrained implant type with comparable overall survivorship.,"['From March 2007 to May 2009, we recruited 160 patients in a prospective, single centered, randomized controlled trial']","['fixed (FB) and mobile bearing (MB) implants', '81 FB total knee arthroplasty (TKA']","['overall implant survivorship', 'passive maximum flexion', 'radiological analyses (maximum active radiological flexion', 'stair climbing', 'clinical scores (KSS', 'postoperative Knee Society Score (KSS), the passive clinical and active radiological knee flexion, the implant survivorship, the complications, and the presence of radiolucent lines', 'presence of progressive radiolucent lines', 'complication rate', 'pain score']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0443285', 'cui_str': 'Radiolucent'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.0829016,No significant clinical and radiological differences were found between fixed and mobile bearing TKA using the same semi-constrained implant type with comparable overall survivorship.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sappey-Marinier', 'Affiliation': 'Orthopaedics Surgery and Sports Medicine Department, FIFA Medical Center of Excellence, Croix-Rousse Hospital, Lyon University Hospital, 103 Grande rue de la Croix Rousse, 69004, Lyon, France. elliot.sappey-marinier@chu-lyon.fr.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Swan', 'Affiliation': 'Orthopaedics Surgery and Sports Medicine Department, FIFA Medical Center of Excellence, Croix-Rousse Hospital, Lyon University Hospital, 103 Grande rue de la Croix Rousse, 69004, Lyon, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Maucort-Boulch', 'Affiliation': 'Service de Biostatistique - Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, 69003, Lyon, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Batailler', 'Affiliation': 'Orthopaedics Surgery and Sports Medicine Department, FIFA Medical Center of Excellence, Croix-Rousse Hospital, Lyon University Hospital, 103 Grande rue de la Croix Rousse, 69004, Lyon, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Malatray', 'Affiliation': 'Orthopaedics Surgery and Sports Medicine Department, FIFA Medical Center of Excellence, Croix-Rousse Hospital, Lyon University Hospital, 103 Grande rue de la Croix Rousse, 69004, Lyon, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Neyret', 'Affiliation': 'Infirmerie Protestante Lyon Caluire, 3 chemin du Penthod, 69300, Caluire et cuire, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lustig', 'Affiliation': 'Orthopaedics Surgery and Sports Medicine Department, FIFA Medical Center of Excellence, Croix-Rousse Hospital, Lyon University Hospital, 103 Grande rue de la Croix Rousse, 69004, Lyon, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Servien', 'Affiliation': 'Orthopaedics Surgery and Sports Medicine Department, FIFA Medical Center of Excellence, Croix-Rousse Hospital, Lyon University Hospital, 103 Grande rue de la Croix Rousse, 69004, Lyon, France.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06346-1']
1918,33143547,No significant effect of caffeine on five kilometer running performance after muscle damage.,"Caffeine has documented hypoalgesic effects during exercise. However, there is a lack of research focusing on caffeine's potential analgesic effects to ameliorate delayed onset muscle soreness. A placebo controlled randomized cross-over trial was carried out to determine if 5 mg/kg of body weight (mg/kgBW) of caffeine attenuates muscle pain and improves 5 k running performance following delayed onset muscle soreness. Prior to participating, eleven runners (9 male; 2 female; age, 24.5 ± 6.3 years; height, 173.6 ± 7.8 cm; body mass, 66.3 ± 7.5 kg; BMI, 23.18 kg/m 2 ± 1.6; VO 2max 61.0 ± 6.1 ml/kg/min -1 ), were asked to discontinue supplement use for 72 hours and abstain from caffeine consumption for 48 hours. Participants performed a 30-minute downhill run on a treadmill set at -10% grade at 70% VO 2max to induce delayed onset of muscle soreness. Participants then returned 48 hours after to complete a 5 k time trial run where they consumed either 5 mg/kgBW of caffeine or a placebo. Rate of perceived exertion and heart rate were taken every two minutes during the trial. There was no detectable statistical difference between 5 k performance between caffeine (1074.9 ± 119.7 sec) or placebo (1053.8 ± 86.8 sec) ( p = .41). Algometer readings were similar between both treatments for muscle soreness in the rectus femoris ( p = .791) and the vastus medialis oblique ( p = .371). Muscle soreness ratings were found to be greater in the caffeine condition compared to the placebo condition ( p = .030). There was no effect of treatment on rating of perceived exertion between conditions ( p = .574). The present study suggests that caffeine is not effective at reducing muscle soreness, rating of perceived exertion, or improving running performance in a time trial in the presence of muscle soreness.",2020,Muscle soreness ratings were found to be greater in the caffeine condition compared to the placebo condition ( p = .030).,"['Prior to participating, eleven runners (9 male; 2 female; age, 24.5\xa0±\xa06.3\xa0years; height, 173.6\xa0±\xa07.8\xa0cm; body mass, 66.3\xa0±\xa07.5\xa0kg; BMI, 23.18\xa0kg/m 2 \xa0±\xa01.6; VO 2max 61.0\xa0±']","['placebo', 'caffeine', 'Caffeine', 'caffeine or a placebo']","['Muscle soreness ratings', 'Rate of perceived exertion and heart rate', 'rating of perceived exertion', 'muscle pain and improves 5\xa0k running performance', 'muscle soreness', 'muscle soreness, rating of perceived exertion, or improving running performance']","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517508', 'cui_str': '1.6'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.380358,Muscle soreness ratings were found to be greater in the caffeine condition compared to the placebo condition ( p = .030).,"[{'ForeName': 'Ali M', 'Initials': 'AM', 'LastName': 'Al-Nawaiseh', 'Affiliation': 'Department of Sport Rehabilitation, The Hashemite University, Az-Zarqa, Jordan.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Pritchett', 'Affiliation': 'Central Washington University, Ellensburg, Washington, USA.'}, {'ForeName': 'Kelly Kerr', 'Initials': 'KK', 'LastName': 'Pritchett', 'Affiliation': 'Central Washington University, Ellensburg, Washington, USA.'}, {'ForeName': ""Mo'ath F"", 'Initials': 'MF', 'LastName': 'Bataineh', 'Affiliation': 'Department of Sport Rehabilitation, The Hashemite University, Az-Zarqa, Jordan.'}, {'ForeName': 'Akef M', 'Initials': 'AM', 'LastName': 'Taifour', 'Affiliation': 'Department of Sport Rehabilitation, The Hashemite University, Az-Zarqa, Jordan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bellar', 'Affiliation': 'University of North Carolina, Charlotte, North Carolina, USA.'}, {'ForeName': 'Makenzie A', 'Initials': 'MA', 'LastName': 'Schoeff', 'Affiliation': 'Health and Physical Activity Building, Ball State University, Muncie, Indiana, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Fox', 'Affiliation': 'Health and Physical Activity Building, Ball State University, Muncie, Indiana, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Judge', 'Affiliation': 'Ball Memorial Hospital, Muncie, Indiana, USA.'}, {'ForeName': 'Lawrence W', 'Initials': 'LW', 'LastName': 'Judge', 'Affiliation': 'Health and Physical Activity Building, Ball State University, Muncie, Indiana, USA.'}]",International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition,['10.1024/0300-9831/a000683']
1919,33143731,Efficacy of Tong-Xie-Yao-Fang granule and its impact on whole transcriptome profiling in diarrhea-predominant irritable bowel syndrome patients: study protocol for a randomized controlled trial.,"BACKGROUND
Irritable bowel syndrome (IBS) is one kind of common functional bowel disease with obscure pathogenesis, and exploration about whole transcriptome profiling in IBS-D is still negligible. Conventional medications have limited effects, which makes focus shifted to traditional Chinese medicine (TCM). Tong-Xie-Yao-Fang, as a classic herbal formula in TCM, is pretty effective and safe for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), but the underlying therapeutic mechanism remains unknown. We aim to verify the efficacy and safety of TXYF granule (the formula particles mixed together) in IBS-D and elucidate the gene-level mechanism of IBS-D and therapeutic targets of TXYF granule based on whole transcriptome analysis.
METHODS/DESIGN
This is a randomized, double-blind, and placebo-controlled clinical trial consisting of 2 weeks of run-in period, 12 weeks of treatment period, and 8 weeks of follow-up period. We will enroll 120 participants with IBS-D, who will be randomly assigned to the TXYF granule group and the placebo group, and recruit additional 10 healthy individuals as controls for mechanistic outcome. The two groups respectively take TXYF granule or placebo orally for treatment. The primary outcome is the response rate of IBS-Symptom Severity Score (IBS-SSS). The secondary outcomes include adequate relief (AR), IBS-Quality of Life Questionnaire (IBS-QOL), and long-term efficacy. Mechanistic outcome is the whole transcriptome profiling of the intestinal mucosae from IBS participants before and after the treatment and healthy individuals.
DISCUSSION
This trial will prove the effectiveness and safety of TXYF granule with high-quality evidence and provide a penetrating and comprehensive perspective on the molecular mechanism of IBS-D by whole transcriptome analysis, which makes us pinpoint specific biomarkers of IBS-D and therapeutic targets of TXYF.
TRIAL REGISTRATION
Chinese Clinical Trial Registry ChiCTR-IOR-1900021785 . Registered on 9 March 2019.",2020,"The secondary outcomes include adequate relief (AR), IBS-Quality of Life Questionnaire (IBS-QOL), and long-term efficacy.","['120 participants with IBS-D', 'diarrhea-predominant irritable bowel syndrome patients']","['TXYF granule or placebo', 'placebo', 'TXYF granule group and the placebo', 'Tong-Xie-Yao-Fang granule']","['response rate of IBS-Symptom Severity Score (IBS-SSS', 'adequate relief (AR), IBS-Quality of Life Questionnaire (IBS-QOL), and long-term efficacy']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183964', 'cui_str': 'Tong'}, {'cui': 'C0574439', 'cui_str': 'Fang language'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",120.0,0.3199,"The secondary outcomes include adequate relief (AR), IBS-Quality of Life Questionnaire (IBS-QOL), and long-term efficacy.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yong-Quan', 'Initials': 'YQ', 'LastName': 'Huang', 'Affiliation': 'Department of Orthopedics, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Shui-Lian', 'Initials': 'SL', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Chang-Rong', 'Initials': 'CR', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xin-Lin', 'Initials': 'XL', 'LastName': 'Chen', 'Affiliation': 'Department of Preventive Medicine and Health Statistics, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Qiu-Ke', 'Initials': 'QK', 'LastName': 'Hou', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. houqiuke@gzucm.edu.cn.'}, {'ForeName': 'Feng-Bin', 'Initials': 'FB', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. liufb163@126.com.'}]",Trials,['10.1186/s13063-020-04833-x']
1920,33143755,Weight gain and body composition during pregnancy: a randomized pilot trial with probiotics and/or fish oil.,"We evaluated the effects of fish oil and/or probiotic supplementation in a randomized placebo-controlled intervention pilot trial on gestational weight gain (GWG) and body composition. Additionally, the influence of gestational diabetes (GDM) on GWG and body composition was assessed. We randomized 439 overweight or obese women (mean 13.9±2.1 gestational weeks) into four intervention groups: fish oil+placebo, probiotics+placebo, fish oil+probiotics and placebo+placebo. Fish oil (1.9g docosahexaenoic acid and 0.22g eicosapentaenoic acid) and probiotic supplements (Lactobacillus rhamnosus HN001 and Bifidobacterium animalis ssp. lactis 420, 1010 CFU each) were consumed daily from randomization until delivery. GDM was diagnosed with 2-hour 75g oral glucose tolerance test. Body composition was measured with air displacement plethysmography at randomization and in late pregnancy (mean 35.2±0.9 gestational weeks). Fish oil and/or probiotic intervention did not influence mean GWG or change in body fat mass or body fat percentage of the women (p>0.17 for all comparisons). Body composition in early pregnancy did not differ between the women who did or did not develop GDM (adjusted p>0.23). Compared to the normoglycemic women (n=278), women diagnosed with GDM (n=119) gained less weight (7.7±0.4kg vs. 9.3±0.4kg, adjusted mean difference -1.66 [-2.52, -0.80],p<0.001) and fat mass (0.4±0.4kg vs. 1.8±0.3kg, adjusted mean difference -1.43 [-2.19, -0.67],p<0.001) during the follow-up. In conclusion, adiposity of pregnant overweight and obese women was not affected by supplementation with fish oil and/or probiotics, nor did it predict the development of GDM. However, adiposity was reduced in women with GDM compared to normoglycemic women irrespective of the nutritional intervention.",2020,Fish oil and/or probiotic intervention did not influence mean GWG or change in body fat mass or body fat percentage of the women (p>0.17 for all comparisons).,"['439 overweight or obese women (mean 13.9±2.1 gestational weeks) into four intervention groups: fish', 'during pregnancy', 'pregnant overweight and obese women']","['probiotics and/or fish oil', 'placebo', 'fish oil and/or probiotic supplementation', 'oil+placebo, probiotics+placebo, fish oil+probiotics and placebo+placebo. Fish oil (1.9g docosahexaenoic acid and 0.22g eicosapentaenoic acid) and probiotic supplements (Lactobacillus rhamnosus HN001 and Bifidobacterium animalis ssp', 'GDM', 'Fish oil and/or probiotic intervention']","['gestational weight gain (GWG) and body composition', 'weight', 'adiposity', 'Weight gain and body composition', 'fat mass', 'Body composition', 'gestational diabetes (GDM) on GWG and body composition', 'body fat mass or body fat percentage']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C1857069', 'cui_str': 'Schöpf-Schulz-Passarge syndrome'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",439.0,0.359241,Fish oil and/or probiotic intervention did not influence mean GWG or change in body fat mass or body fat percentage of the women (p>0.17 for all comparisons).,"[{'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Pellonperä', 'Affiliation': 'University of Turku and Turku University Hospital, Department of Obstetrics and Gynecology.'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Vahlberg', 'Affiliation': 'University of Turku, Institute of Clinical Medicine, Biostatistics.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Mokkala', 'Affiliation': 'University of Turku, Institute of Biomedicine, Integrative Physiology and Pharmacology.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Houttu', 'Affiliation': 'University of Turku, Institute of Biomedicine, Integrative Physiology and Pharmacology.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Koivuniemi', 'Affiliation': 'University of Turku, Institute of Biomedicine, Integrative Physiology and Pharmacology.'}, {'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Tertti', 'Affiliation': 'University of Turku and Turku University Hospital, Department of Obstetrics and Gynecology.'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Rönnemaa', 'Affiliation': 'University of Turku and Turku University Hospital, Department of Medicine.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Laitinen', 'Affiliation': 'University of Turku, Institute of Biomedicine, Integrative Physiology and Pharmacology.'}]",The British journal of nutrition,['10.1017/S0007114520004407']
1921,33143774,"Body composition, not dietary fatty acid composition, explains metabolic responses following a high-fat meal in premenopausal normal weight women: A single-blind randomized crossover study.","The aim of this study was to examine the effect of three different fatty acid (FA)-rich meals enriched in either saturated (SFA), monounsaturated (MUFA), or polyunsaturated (PUFA) on postprandial metabolic responses in premenopausal, normal weight women. For this randomized, single-blind, crossover study three high-fat (HF) meals rich in either SFA, MUFA, or PUFA (65% energy from fat; 35% of participants' total daily energy needs) were tested. For each visit, anthropometrics and resting metabolic rate were measured following a 12-15h fast. Then, participants consumed one of the HF meals and respiratory gases were collected using indirect calorimetry for 3h postprandially. Energy expenditure (EE) following a SFA-rich meal was a significantly higher than a MUFA-rich meal (p=0.04; η2 = .19) but SFA was not significantly different from PUFA. There was a trend towards significance in EE between PUFA and MUFA (p=0.06). After adjusting for fat-free mass (FFM), there were no longer condition or time effects for EE, although FFM remained a significant predictor (p=0.005; η2=.45). There were no significant differences between conditions for dietary induced thermogenesis (DIT) or substrate oxidation. A relationship between fat-mass (FM) and both total fat oxidation (r=.62; p=0.025) and total change in respiratory exchange ratio following a MUFA-rich meal, was observed (r=-.55; p=0.05). In conclusion, weight loss through increases in EE may be best achieved by increasing FFM rather than selection of FA type. Further, a relationship exists between FM and fat oxidation following a MUFA-rich meal, most likely due to an unidentified mechanism.",2020,Energy expenditure (EE) following a SFA-rich meal was a significantly higher than a MUFA-rich meal (p=0.04; η2 = .19) but SFA was not significantly different from PUFA.,"['premenopausal normal weight women', 'premenopausal, normal weight women']","['fatty acid (FA)-rich meals enriched in either saturated (SFA), monounsaturated (MUFA), or polyunsaturated (PUFA']","['dietary induced thermogenesis (DIT) or substrate oxidation', 'total change in respiratory exchange ratio', 'weight loss', 'fat-mass (FM) and both total fat oxidation', 'Energy expenditure (EE', 'postprandial metabolic responses', 'anthropometrics and resting metabolic rate']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}]",,0.107863,Energy expenditure (EE) following a SFA-rich meal was a significantly higher than a MUFA-rich meal (p=0.04; η2 = .19) but SFA was not significantly different from PUFA.,"[{'ForeName': 'Austin J', 'Initials': 'AJ', 'LastName': 'Graybeal', 'Affiliation': 'Department of Kinesiology, Harris College of Nursing & Health Sciences, Texas Christian University, Fort Worth, TX76129, USA. Email address: austin.graybeal@tcu.edu.'}, {'ForeName': 'Jada L', 'Initials': 'JL', 'LastName': 'Willis', 'Affiliation': 'Department of Nutritional Sciences, College of Science & Engineering, Texas Christian University, Fort Worth, TX76129, USA. Email address: jada.willis@tcu.edu.'}]",The British journal of nutrition,['10.1017/S0007114520004419']
1922,33143944,"[Reliability and validity of the mental evocation of images, movements and activities questionnaire: a pilot study].","INTRODUCTION AND OBJECTIVES
Motor imaging is a widely used technique in neurological rehabilitation. Its utility and results are influenced by the ability to imagine a movement, which can be evaluated by various instruments. This study aimed to assess the psychometric properties of a recently-designed instrument for assessment of the hand and arm: the Mental Evocation of Images, Movements and Activities Questionnaire.
MATERIALS AND METHODS
We assessed 29 patients (41% men and 59% women) with a mean age of 45 years. At a first visit, all were administered the Mental Evocation of Images, Movements and Activities Questionnaire and the Spanish version of the Movement Imagery Questionnaire-Revised. At a second visit, the patients underwent a retest of the Mental Evocation of Images, Movements and Activities Questionnaire. We calculated descriptive statistics, internal consistency, test-retest reliability, reproducibility and concurrent validity between the two instruments.
RESULTS
Reliability/internal consistency: we found good indexes of internal consistency both for the global scale and for its two subscales: evocation and sensation. Reliability/test-retest: we found no significant differences in a 1-week interval. Reproducibility: we found an excellent intraclass correlation coefficient. Concurrent validity: the Mental Evocation of Images, Movements and Activities Questionnaire showed a strong correlation with the Movement Imagery Questionnaire-Revised.
CONCLUSIONS
The Mental Evocation of Images, Movements and Activities Questionnaire is a psychometrically robust instrument that can be used to measure the ability to form visual and kinesthetic mental images of the hand/arm. The instrument also provides information on the imaging process in the person under evaluation.",2020,"Concurrent validity: the Mental Evocation of Images, Movements and Activities Questionnaire showed a strong correlation with the Movement Imagery Questionnaire-Revised.
",['We assessed 29 patients (41% men and 59% women) with a mean age of 45 years'],[],"['Reliability and validity of the mental evocation of images, movements and activities questionnaire', 'Mental Evocation of Images, Movements and Activities Questionnaire and the Spanish version of the Movement Imagery Questionnaire-Revised', 'Reliability/test-retest', 'Mental Evocation of Images, Movements and Activities Questionnaire', 'Movement Imagery Questionnaire-Revised', 'Reproducibility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0035036', 'cui_str': 'Reliability and Validity'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",29.0,0.0213985,"Concurrent validity: the Mental Evocation of Images, Movements and Activities Questionnaire showed a strong correlation with the Movement Imagery Questionnaire-Revised.
","[{'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Zisa', 'Affiliation': 'Centro Logros Terapia Infantil, Majadahonda, Madrid, España.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rubio', 'Affiliation': 'Departamento de Ciencias de la Ocupación, Logopedia, Psicología Evolutiva y de la Educación, Facultad de Psicología, Universidad Católica de Valencia San Vicente Mártir, Valencia, España. Electronic address: cesar.rubio@ucv.es.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gómez', 'Affiliation': 'Instituto de Rehabilitación Funcional La Salle, Madrid, España.'}]",Rehabilitacion,['10.1016/j.rh.2020.09.004']
1923,33143950,"Re: Beatriz Goulao, Sonya Carnell, Jing Shen, et al. Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial). Eur Urol 2020;78:572-80.",,2020,,['Recurrent Bulbar Urethral Stricture'],['Open Urethroplasty Versus Endoscopic Urethrotomy'],[],"[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0194550', 'cui_str': 'Incision of urethra'}]",[],,0.0173346,,"[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Max Super Speciality Hospital Saket, Saket, New Delhi, India. Electronic address: dramitbansalurology@gmail.com.'}, {'ForeName': 'Ruchir', 'Initials': 'R', 'LastName': 'Maheshwari', 'Affiliation': 'Max Super Speciality Hospital Saket, Saket, New Delhi, India.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Max Super Speciality Hospital Saket, Saket, New Delhi, India.'}]",European urology,['10.1016/j.eururo.2020.10.008']
1924,33143987,Pediatric Primary Care Provider Perspectives on a Computer-Facilitated Screening and Brief Intervention System for Adolescent Substance Use.,"PURPOSE
This study aimed to elicit pediatric primary care providers' (PCPs) feedback on the acceptability and feasibility of implementing a tablet computer-facilitated Screening and Brief Intervention (cSBI) system for adolescent substance use in their practices.
METHODS
We trained PCPs at five Boston area practices and enrolled their 12- to 18-year-old patients in a pilot randomized trial of cSBI versus usual care. PCPs completed an 18-item poststudy questionnaire. We computed frequencies and thematically coded open-ended responses.
RESULTS
The analysis sample included 49 of 54 participating PCPs (90.7%). Overall, 89.8% of participants agreed the cSBI system was useful, and 81.6% reported increased confidence in providing brief counseling. Most useful were the immediate availability of screen results, talking points on substance use risks, and counseling prompts. Challenges included time and unfamiliarity with tablet computers. Many suggested electronic health record integration of cSBI to improve efficiency.
CONCLUSIONS
cSBI showed high acceptability and increased confidence among pediatric PCPs. Feasibility could be enhanced by electronic health record integration.",2020,"Overall, 89.8% of participants agreed the cSBI system was useful, and 81.6% reported increased confidence in providing brief counseling.","['We trained PCPs at five Boston area practices and enrolled their 12- to 18-year-old patients', 'adolescent substance use in their practices']","['cSBI versus usual care', 'implementing a tablet computer-facilitated Screening and Brief Intervention (cSBI) system', 'Computer-Facilitated Screening and Brief Intervention System']",['confidence in providing brief counseling'],"[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C4045980', 'cui_str': 'Tablet Computers'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",,0.0576502,"Overall, 89.8% of participants agreed the cSBI system was useful, and 81.6% reported increased confidence in providing brief counseling.","[{'ForeName': 'Erin B', 'Initials': 'EB', 'LastName': 'Gibson', 'Affiliation': 'Division of General Internal Medicine, Boston Medical Center, Charlestown, Massachusetts. Electronic address: erin.gibson@bmc.org.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Knight', 'Affiliation': ""The Center for Adolescent Substance Use and Addiction Research (CeASAR), Boston Children's Hospital, Boston, Massachusetts; Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, Massachusetts; Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Levinson', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, California.'}, {'ForeName': 'Lon', 'Initials': 'L', 'LastName': 'Sherritt', 'Affiliation': ""The Center for Adolescent Substance Use and Addiction Research (CeASAR), Boston Children's Hospital, Boston, Massachusetts; Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Sion K', 'Initials': 'SK', 'LastName': 'Harris', 'Affiliation': ""The Center for Adolescent Substance Use and Addiction Research (CeASAR), Boston Children's Hospital, Boston, Massachusetts; Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, Massachusetts; Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.""}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.09.037']
1925,33144086,Efficacy and Safety of Dapagliflozin in Acute Heart Failure: Rationale and Design of the DICTATE-AHF trial.,"BACKGROUND
Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, reduces cardiovascular death and worsening heart failure in patients with chronic heart failure and reduced ejection fraction. Early initiation during an acute heart failure (AHF) hospitalization may facilitate decongestion, improve natriuresis, and facilitate safe transition to a beneficial outpatient therapy for both diabetes and heart failure.
OBJECTIVE
The objective is to assess the efficacy and safety of initiating dapagliflozin within the first 24-hours of hospitalization in patients with AHF compared to usual care.
METHODS
DICTATE-AHF is a prospective, multicenter, open-label, randomized trial enrolling a planned 240 patients in the United States. Patients with type 2 diabetes hospitalized with hypervolemic AHF and an estimated glomerular filtration rate of at least 30 ml/min/1.73m 2 are eligible for participation. Patients are randomly assigned 1:1 to dapagliflozin 10mg once daily or structured usual care until day 5 or hospital discharge. Both treatment arms receive protocolized diuretic and insulin therapies. The primary endpoint is diuretic response expressed as the cumulative change in weight per cumulative loop diuretic dose in 40mg intravenous furosemide equivalents. Secondary and exploratory endpoints include inpatient worsening AHF, 30-day hospital readmission for AHF or diabetic reasons, change in NT-proBNP, and measures of natriuresis. Safety endpoints include the incidence of hyper/hypoglycemia, ketoacidosis, worsening kidney function, hypovolemic hypotension, and inpatient mortality.
CONCLUSION
The DICTATE-AHF trial will establish the efficacy and safety of early initiation of dapagliflozin during AHF across both AHF and diabetic outcomes in patients with diabetes.",2020,"Safety endpoints include the incidence of hyper/hypoglycemia, ketoacidosis, worsening kidney function, hypovolemic hypotension, and inpatient mortality.
","['planned 240 patients in the United States', 'patients with chronic heart failure and reduced ejection fraction', 'Acute Heart Failure', 'Patients with type 2 diabetes hospitalized with hypervolemic AHF and an estimated glomerular filtration rate of at least 30 ml/min/1.73m 2 are eligible for participation', 'patients with diabetes', 'patients with AHF compared to usual care']","['dapagliflozin 10mg once daily or structured usual care until day 5 or hospital discharge', 'protocolized diuretic and insulin therapies', 'Dapagliflozin', 'dapagliflozin']","['diuretic response expressed as the cumulative change in weight per cumulative loop diuretic dose', 'incidence of hyper/hypoglycemia, ketoacidosis, worsening kidney function, hypovolemic hypotension, and inpatient mortality', 'efficacy and safety', 'inpatient worsening AHF, 30-day hospital readmission for AHF or diabetic reasons, change in NT-proBNP, and measures of natriuresis', 'Efficacy and Safety', 'cardiovascular death']","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0354100', 'cui_str': 'Loop diuretic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0752266', 'cui_str': 'Hypovolemic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027477', 'cui_str': 'Natriuresis'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0905358,"Safety endpoints include the incidence of hyper/hypoglycemia, ketoacidosis, worsening kidney function, hypovolemic hypotension, and inpatient mortality.
","[{'ForeName': 'Zachary L', 'Initials': 'ZL', 'LastName': 'Cox', 'Affiliation': 'Department of Pharmacy Practice, Lipscomb University College of Pharmacy, Nashville TN, USA; Department of Pharmacy, Vanderbilt University Medical Center, Nashville TN, USA. Electronic address: Zachary.l.cox@vumc.org.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville TN, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Aaron', 'Affiliation': 'Department of Cardiac Sciences, Saint Thomas West Hospital, Nashville TN, USA.'}, {'ForeName': 'Gabriel A', 'Initials': 'GA', 'LastName': 'Hernandez', 'Affiliation': 'Division of Cardiology, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'A Thomas McRae', 'Initials': 'ATM', 'LastName': 'Iii', 'Affiliation': 'TriStar Centennial Medical Center, Nashville TN, USA.'}, {'ForeName': 'Beth T', 'Initials': 'BT', 'LastName': 'Davidson', 'Affiliation': 'TriStar Centennial Medical Center, Nashville TN, USA.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Fowler', 'Affiliation': 'Division of Diabetes, Endocrinology, & Metabolism, Vanderbilt University Medical Center, Nashville TN, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Frank E Harrell', 'Initials': 'FEH', 'LastName': 'Jr', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Cathy A', 'Initials': 'CA', 'LastName': 'Jenkins', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kampe', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville TN, USA.'}, {'ForeName': 'Karen F', 'Initials': 'KF', 'LastName': 'Miller', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville TN, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Stubblefield', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville TN, USA.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Division of Cardiology, Vanderbilt University Medical Center, Nashville TN, USA.'}]",American heart journal,['10.1016/j.ahj.2020.10.071']
1926,33144126,Prognostic implications of myocardial injury in patients with and without COVID-19 infection treated in a university hospital.,"INTRODUCTION AND OBJECTIVES
Cardiac troponin, a marker of myocardial injury, is frequently observed in patients with COVID-19 infection. Our objective was to analyze myocardial injury and its prognostic implications in patients with and without COVID-19 infection treated in the same period of time.
METHODS
The present study included patients treated in a university hospital with cardiac troponin I measurements and with suspected COVID-19 infection, confirmed or ruled out by polymerase chain reaction analysis. The impact was analyzed of cardiac troponin I positivity on 30-day mortality.
RESULTS
In total, 433 patients were distributed among the following groups: confirmed COVID-19 (n=186), 22% with myocardial injury (n=41); and ruled out COVID-19 (n=247), 21.5% with myocardial injury (n=52). The confirmed and ruled out COVID-19 groups had a similar age, sex, and cardiovascular history. Mortality was significantly higher in the confirmed COVID-19 group than in the ruled out group (19.9% vs 5.3%, P <.001). In Cox multivariate regression analysis, cardiac troponin I was a predictor of mortality in both groups (confirmed COVID-19 group: HR, 3.54; 95%CI, 1.70-7.34; P=.001; ruled out COVID-19 group: HR, 5.57; 95%CI, 1.70-18.20; P=.004). The predictive model analyzed by ROC curves was similar in the 2 groups (P=.701), with AUCs of 0.808 in the confirmed COVID-19 group (0.750-0.865) and 0.812 in the ruled out COVID-19 group (0.760-0.864).
CONCLUSIONS
Myocardial injury is detected in 1 in every 5 patients with confirmed or ruled out COVID-19 and predicts 30-day mortality to a similar extent in both circumstances.",2020,"The predictive model analyzed by ROC curves was similar in the 2 groups (P=.701), with AUCs of 0.808 in the confirmed COVID-19 group (0.750-0.865) and 0.812 in the ruled out COVID-19 group (0.760-0.864).
","['patients with COVID-19 infection', 'patients treated in a university hospital with cardiac troponin', 'patients with and without COVID-19 infection treated in the same period of time', 'patients with and without COVID-19 infection treated in a university hospital', '433 patients were distributed among the following groups: confirmed COVID-19 (n=186), 22% with myocardial injury (n=41); and ruled out COVID-19 (n=247), 21.5% with myocardial injury (n=52']",[],"['Mortality', 'cardiac troponin', '30-day mortality', 'ROC curves', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}]",433.0,0.229356,"The predictive model analyzed by ROC curves was similar in the 2 groups (P=.701), with AUCs of 0.808 in the confirmed COVID-19 group (0.750-0.865) and 0.812 in the ruled out COVID-19 group (0.760-0.864).
","[{'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Bardají', 'Affiliation': ""Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, Spain; Universidad Rovira Virgili, Tarragona, Spain; Institut d'Investigació Sanitària Pere Virgili (IISPV), Tarragona, Spain. Electronic address: abardaji.hj23.ics@gencat.cat.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Carrasquer', 'Affiliation': ""Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, Spain; Universidad Rovira Virgili, Tarragona, Spain; Institut d'Investigació Sanitària Pere Virgili (IISPV), Tarragona, Spain.""}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Sánchez-Giménez', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, Spain.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Lal-Trehan', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Del-Moral-Ronda', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, Spain.'}, {'ForeName': 'Óscar M', 'Initials': 'ÓM', 'LastName': 'Peiró', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, Spain.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Bonet', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, Spain.'}, {'ForeName': 'Gislaine', 'Initials': 'G', 'LastName': 'Castilho', 'Affiliation': ""Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, Spain; Institut d'Investigació Sanitària Pere Virgili (IISPV), Tarragona, Spain.""}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Fort-Gallifa', 'Affiliation': ""Laboratori Clínic ICS Camp de Tarragona-Terres de l'Ebre, Instituto Catalán de la Salud, Tarragona, Spain.""}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Benavent', 'Affiliation': ""Laboratori Clínic ICS Camp de Tarragona-Terres de l'Ebre, Instituto Catalán de la Salud, Tarragona, Spain.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Recio', 'Affiliation': ""Laboratori Clínic ICS Camp de Tarragona-Terres de l'Ebre, Instituto Catalán de la Salud, Tarragona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gutiérrez', 'Affiliation': ""Laboratori Clínic ICS Camp de Tarragona-Terres de l'Ebre, Instituto Catalán de la Salud, Tarragona, Spain.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Villavicencio', 'Affiliation': 'Servicio de Cuidados Intensivos, Hospital Universitario de Tarragona Joan XXIII, Tarragona, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Auguet', 'Affiliation': ""Universidad Rovira Virgili, Tarragona, Spain; Institut d'Investigació Sanitària Pere Virgili (IISPV), Tarragona, Spain; Servicio de Medicina Interna, Hospital Universitario de Tarragona Joan XXIII, Tarragona, Spain.""}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Boqué', 'Affiliation': ""Universidad Rovira Virgili, Tarragona, Spain; Institut d'Investigació Sanitària Pere Virgili (IISPV), Tarragona, Spain; Servicio de Urgencias, Hospital Universitario de Tarragona Joan XXIII, Tarragona, Spain.""}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2020.08.027']
1927,33144278,Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial).,,2020,,['moderate covid-19 in adults in India'],[],[],"[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021201', 'cui_str': 'India'}]",[],[],,0.0921692,,[],BMJ (Clinical research ed.),['10.1136/bmj.m4232']
1928,33144299,"Transcutaneous auricular vagus nerve stimulation reduces pain and fatigue in patients with systemic lupus erythematosus: a randomised, double-blind, sham-controlled pilot trial.","OBJECTIVES
Musculoskeletal pain and fatigue are common features in systemic lupus erythematosus (SLE). The cholinergic anti-inflammatory pathway is a physiological mechanism diminishing inflammation, engaged by stimulating the vagus nerve. We evaluated the effects of non-invasive vagus nerve stimulation in patients with SLE and with musculoskeletal pain.
METHODS
18 patients with SLE and with musculoskeletal pain ≥4 on a 10 cm Visual Analogue Scale were randomised (2:1) in this double-blind study to receive transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation (SS) for 4 consecutive days. Evaluations at baseline, day 5 and day 12 included patient assessments of pain, disease activity (PtGA) and fatigue. Tender and swollen joint counts and the Physician Global Assessment (PGA) were completed by a physician blinded to the patient's therapy. Potential biomarkers were evaluated.
RESULTS
taVNS and SS were well tolerated. Subjects receiving taVNS had a significant decrease in pain and fatigue compared with SS and were more likely (OR=25, p=0.02) to experience a clinically significant reduction in pain. PtGA, joint counts and PGA also improved. Pain reduction and improvement of fatigue correlated with the cumulative current received. In general, responses were maintained through day 12. Plasma levels of substance P were significantly reduced at day 5 compared with baseline following taVNS but other neuropeptides, serum and whole blood-stimulated inflammatory mediators, and kynurenine metabolites showed no significant change at days 5 or 12 compared with baseline.
CONCLUSION
taVNS resulted in significantly reduced pain, fatigue and joint scores in SLE. Additional studies evaluating this intervention and its mechanisms are warranted.",2020,"Plasma levels of substance P were significantly reduced at day 5 compared with baseline following taVNS but other neuropeptides, serum and whole blood-stimulated inflammatory mediators, and kynurenine metabolites showed no significant change at days 5 or 12 compared with baseline.
","['18 patients with SLE and with musculoskeletal pain ≥4 on a 10\u2009cm Visual Analogue Scale', 'patients with SLE and with musculoskeletal pain', 'patients with systemic lupus erythematosus']","['transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation (SS', 'non-invasive vagus nerve stimulation', 'Transcutaneous auricular vagus nerve stimulation']","['pain, disease activity (PtGA) and fatigue', 'Tender and swollen joint counts and the Physician Global Assessment (PGA', 'Plasma levels of substance P', 'pain, fatigue and joint scores', 'tolerated', 'Musculoskeletal pain and fatigue', 'Pain reduction and improvement of fatigue', 'PtGA, joint counts and PGA', 'pain and fatigue', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0234234', 'cui_str': 'Tender'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",18.0,0.403758,"Plasma levels of substance P were significantly reduced at day 5 compared with baseline following taVNS but other neuropeptides, serum and whole blood-stimulated inflammatory mediators, and kynurenine metabolites showed no significant change at days 5 or 12 compared with baseline.
","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Aranow', 'Affiliation': 'Feinstein Institutes for Medical Research, Manhasset, New York, USA caranow@northwell.edu.'}, {'ForeName': 'Yemil', 'Initials': 'Y', 'LastName': 'Atish-Fregoso', 'Affiliation': 'Feinstein Institutes for Medical Research, Manhasset, New York, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lesser', 'Affiliation': 'Biostatistics Unit, Feinstein Institutes for Medical Research, Manhasset, New York, USA.'}, {'ForeName': 'Meggan', 'Initials': 'M', 'LastName': 'Mackay', 'Affiliation': 'Feinstein Institutes for Medical Research, Manhasset, New York, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Anderson', 'Affiliation': 'Feinstein Institutes for Medical Research, Manhasset, New York, USA.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Chavan', 'Affiliation': 'Institute of Bioelectronic Medicine, Feinstein Institutes for Medical Research, Manhasset, New York, USA.'}, {'ForeName': 'Theodoros P', 'Initials': 'TP', 'LastName': 'Zanos', 'Affiliation': 'Institute of Bioelectronic Medicine, Feinstein Institutes for Medical Research, Manhasset, New York, USA.'}, {'ForeName': 'Timir', 'Initials': 'T', 'LastName': 'Datta-Chaudhuri', 'Affiliation': 'Institute of Bioelectronic Medicine, Feinstein Institutes for Medical Research, Manhasset, New York, USA.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Bouton', 'Affiliation': 'Institute of Bioelectronic Medicine, Feinstein Institutes for Medical Research, Manhasset, New York, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Tracey', 'Affiliation': 'Institute of Bioelectronic Medicine, Feinstein Institutes for Medical Research, Manhasset, New York, USA.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Diamond', 'Affiliation': 'Feinstein Institutes for Medical Research, Manhasset, New York, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217872']
1929,33144344,Effects of a low carbohydrate diet on energy expenditure during weight loss maintenance: randomized trial.,,2020,,[],['low carbohydrate diet'],['energy expenditure during weight loss maintenance'],[],"[{'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}]","[{'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",,0.0388728,,[],BMJ (Clinical research ed.),['10.1136/bmj.m4264']
1930,33144346,Are web-based personallytailored physical activity videos more effective than personally tailored text-based interventions? Results from the three-arm randomised controlled TaylorActive trial.,"OBJECTIVES
Some online, personally tailored, text-based physical activity interventions have proven effective. However, people tend to 'skim' and 'scan' web-based text rather than thoroughly read their contents. In contrast, online videos are more engaging and popular. We examined whether web-based personally tailored physical activity videos were more effective in promoting physical activity than personally tailored text and generic information.
METHODS
501 adults were randomised into a video-tailored intervention, text-tailored intervention or control. Over a 3-month period, intervention groups received access to eight sessions of web-based personally tailored physical activity advice. Only the delivery method differed between intervention groups: tailored video versus tailored text. The primary outcome was 7-day ActiGraph-GT3X+ measured moderate-to-vigorous physical activity (MVPA) assessed at 0, 3 and 9 months. Secondary outcomes included self-reported MVPA and website engagement. Differences were examined using generalised linear mixed models with intention-to-treat and multiple imputation.
RESULTS
Accelerometer-assessed MVPA increased 23% in the control (1.23 (1.06, 1.43)), 12% in the text-tailored (1.12 (0.95, 1.32)) and 28% in the video-tailored (1.28 (1.06, 1.53)) groups at the 3-month follow-up only, though there were no significant between-group differences. Both text-tailored (1.77 (1.37, 2.28]) and video-tailored (1.37 (1.04, 1.79)) groups significantly increased self-reported MVPA more than the control group at 3 months only, but there were no differences between video-tailored and text-tailored groups. The video-tailored group spent significantly more time on the website compared with text-tailored participants (90 vs 77 min, p=0.02).
CONCLUSIONS
The personally tailored videos were not more effective than personally tailored text in increasing MVPA. The findings from this study conflict with pilot study outcomes and previous literature. Process evaluation and mediation analyses will provide further insights.
TRIAL REGISTRATION NUMBER
ACTRN12615000057583.",2020,"The video-tailored group spent significantly more time on the website compared with text-tailored participants (90 vs 77 min, p=0.02).
",['501 adults'],"['access to eight sessions of web-based personally tailored physical activity advice', 'web-based personally tailored physical activity videos', 'video-tailored intervention, text-tailored intervention or control']","['7-day ActiGraph-GT3X+ measured moderate-to-vigorous physical activity (MVPA', 'self-reported MVPA', 'self-reported MVPA and website engagement', 'MVPA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",501.0,0.0719686,"The video-tailored group spent significantly more time on the website compared with text-tailored participants (90 vs 77 min, p=0.02).
","[{'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'Appleton Institute, Central Queensland University, Rockhampton, Queensland, Australia c.vandelanotte@cqu.edu.au.'}, {'ForeName': 'Camille E', 'Initials': 'CE', 'LastName': 'Short', 'Affiliation': 'Faculty of Medicine, Dentistry and Health Science, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Plotnikoff', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Rebar', 'Affiliation': 'Appleton Institute, Central Queensland University, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Alley', 'Affiliation': 'Appleton Institute, Central Queensland University, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Schoeppe', 'Affiliation': 'Appleton Institute, Central Queensland University, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Doreen F', 'Initials': 'DF', 'LastName': 'Canoy', 'Affiliation': 'Appleton Institute, Central Queensland University, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Hooker', 'Affiliation': 'Appleton Institute, Central Queensland University, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Power', 'Affiliation': 'Appleton Institute, Central Queensland University, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Hunter Medical Research Institute, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Leigh', 'Affiliation': 'Hunter Medical Research Institute, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Quyen', 'Initials': 'Q', 'LastName': 'To', 'Affiliation': 'Appleton Institute, Central Queensland University, Rockhampton, Queensland, Australia.'}, {'ForeName': 'W Kerry', 'Initials': 'WK', 'LastName': 'Mummery', 'Affiliation': 'Faculty of Kinesiology, Sport and Recreation, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Mitch J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, The University of Newcastle, Callaghan, New South Wales, Australia.'}]",British journal of sports medicine,['10.1136/bjsports-2020-102521']
1931,33144354,Intensive Risk Factor Management and Cardiovascular Autonomic Neuropathy in Type 2 Diabetes: The ACCORD Trial.,"OBJECTIVE
The effects of preventive interventions on cardiovascular autonomic neuropathy (CAN) remain unclear. We examined the effect of intensively treating traditional risk factors for CAN, including hyperglycemia, hypertension, and dyslipidemia, in individuals with type 2 diabetes (T2D) and high cardiovascular risk participating in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.
RESEARCH DESIGN AND METHODS
CAN was defined as heart rate variability indices below the fifth percentile of the normal distribution. Of 10,251 ACCORD participants, 71% ( n = 7,275) had a CAN evaluation at study entry and at least once after randomization. The effects of intensive interventions on CAN were analyzed among these subjects through generalized linear mixed models.
RESULTS
As compared with standard intervention, intensive glucose treatment reduced CAN risk by 16% (odds ratio [OR] 0.84, 95% CI 0.75-0.94, P = 0.003)-an effect driven by individuals without cardiovascular disease (CVD) at baseline (OR 0.73, 95% CI 0.63-0.85, P < 0.0001) rather than those with CVD (OR 1.10, 95% CI 0.91-1.34, P = 0.34) ( P interaction = 0.001). Intensive blood pressure (BP) intervention decreased CAN risk by 25% (OR 0.75, 95% CI 0.63-0.89, P = 0.001), especially in patients ≥65 years old (OR 0.66, 95% CI 0.49-0.88, P = 0.005) ( P interaction = 0.05). Fenofibrate did not have a significant effect on CAN (OR 0.91, 95% CI 0.78-1.07, P = 0.26).
CONCLUSIONS
These data confirm a beneficial effect of intensive glycemic therapy and demonstrate, for the first time, a similar benefit of intensive BP control on CAN in T2D. A negative CVD history identifies T2D patients who especially benefit from intensive glycemic control for CAN prevention.",2020,"Fenofibrate did not have a significant effect on CAN (OR 0.91, 95% CI 0.78-1.07, P = 0.26).
","['individuals with type 2 diabetes (T2D) and high cardiovascular risk participating in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial', 'Type 2 Diabetes', 'T2D patients who especially benefit from intensive glycemic control for CAN prevention']","['intensive interventions', 'Intensive Risk Factor Management', 'Fenofibrate', 'preventive interventions']","['Intensive blood pressure (BP) intervention decreased CAN risk', 'CAN risk', 'CAN']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0259749', 'cui_str': 'Autonomic neuropathy'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0259749', 'cui_str': 'Autonomic neuropathy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",10251.0,0.100999,"Fenofibrate did not have a significant effect on CAN (OR 0.91, 95% CI 0.78-1.07, P = 0.26).
","[{'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Hetal', 'Initials': 'H', 'LastName': 'Shah', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Carlos Roberto', 'Initials': 'CR', 'LastName': 'Bueno Junior', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Xiuqin', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Mitri', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sambataro', 'Affiliation': ""Endocrine, Metabolism and Nutrition Disease Unit, Internal Medicine Department, Santa Maria of Ca' Foncello Hospital, Treviso, Italy.""}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Sambado', 'Affiliation': ""Endocrine, Metabolism and Nutrition Disease Unit, Internal Medicine Department, Santa Maria of Ca' Foncello Hospital, Treviso, Italy.""}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'McMaster University and the Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Fonseca', 'Affiliation': 'Section of Endocrinology, Tulane University Health Sciences Center, New Orleans, LA.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Doria', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA rpbusui@med.umich.edu alessandro.doria@joslin.harvard.edu.'}, {'ForeName': 'Rodica Pop', 'Initials': 'RP', 'LastName': 'Busui', 'Affiliation': 'Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI rpbusui@med.umich.edu alessandro.doria@joslin.harvard.edu.'}]",Diabetes care,['10.2337/dc20-1842']
1932,33144358,"Effects of a participatory organisational, core work task focused workplace intervention on employees' primary healthcare consultations: secondary analysis of a cluster RCT.","OBJECTIVES
We aimed to examine whether a participatory organisational workplace intervention focusing on core tasks at work resulted in lower primary healthcare utilisation of employees.
METHODS
The cluster randomised controlled trial included 78 preschools, 44 allocated to the intervention group (1745 employees) and 34 allocated to the control group (1267 employees). The intervention aimed to involve employees in improving the psychosocial work environment while focusing on core tasks at work. Using Poisson regression, we tested the rate ratios (RRs) of consultations in the intervention compared with the control group in terms of all consultations in primary healthcare and general practitioner (GP) consultations, respectively, per person-year during 31 months of follow-up. The fully adjusted model included adjustment for sex, age, job group, workplace type and size, and previous primary healthcare utilisation.
RESULTS
During the follow-up, intervention group employees had 11.0 consultations/person-year, while control group employees had 11.6 consultations/person-year (RR 0.97, 95% CI 0.92 to 1.01). Employees in the intervention group had 7.5 GP consultations/person-year, while control group employees had 8.2 GP consultations/person-year (RR 0.95, 95% CI 0.90 to 0.99). Post hoc analyses indicated that the effect of the intervention was particularly strong in employees in preschools with a moderate or high level of implementation.
CONCLUSIONS
The participatory organisational workplace intervention focusing on core tasks at work among preschool employees had a small, statistically non-significant effect on overall primary healthcare utilisation and a small, statistically significant effect on GP consultations. These results suggest a beneficial effect of the participatory organisational intervention on employees' health.
TRIAL REGISTRATION NUMBER
ISRCTN16271504.",2020,"The participatory organisational workplace intervention focusing on core tasks at work among preschool employees had a small, statistically non-significant effect on overall primary healthcare utilisation and a small, statistically significant effect on GP consultations.","['78 preschools, 44 allocated to the intervention group (1745 employees) and 34 allocated to the control group (1267 employees', ""employees' primary healthcare consultations"", 'employees']","['participatory organisational intervention', 'participatory organisational, core work task focused workplace intervention', 'participatory organisational workplace intervention']","['GP consultations', 'rate ratios (RRs) of consultations']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}]","[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",78.0,0.106123,"The participatory organisational workplace intervention focusing on core tasks at work among preschool employees had a small, statistically non-significant effect on overall primary healthcare utilisation and a small, statistically significant effect on GP consultations.","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Framke', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark elf@nfa.dk.'}, {'ForeName': 'Ole Henning', 'Initials': 'OH', 'LastName': 'Sørensen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Line R M', 'Initials': 'LRM', 'LastName': 'Pedersen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Pedersen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Ida E H', 'Initials': 'IEH', 'LastName': 'Madsen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Jakob B', 'Initials': 'JB', 'LastName': 'Bjorner', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Reiner', 'Initials': 'R', 'LastName': 'Rugulies', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}]",Occupational and environmental medicine,['10.1136/oemed-2020-106558']
1933,33144646,Comparison of two tDCS protocols on pain and EEG alpha-2 oscillations in women with fibromyalgia.,"Transcranial Direct Current Stimulation (tDCS) has been used as an alternative treatment for pain reduction in fibromyalgia. In this study, in addition to behavioral measures, we analyzed oscillations in alpha 2 frequency band in the frontal, occipital, and parietal regions, in response to the application of two neuromodulation protocols in fibromyalgia. The study was a randomized, double-blind, placebo-controlled clinical trial with 31 women diagnosed with fibromyalgia. The participants were allocated to three groups with the anodic stimulation applied on the left motor cortex: Group 1, for five consecutive days; Group 2, for 10 consecutive days; and Group 3, sham stimulation for five consecutive days. Statistical analysis showed a reduction in pain intensity after treatment for groups in general [F (1.28) = 8.02; p = 0.008; η 2 = 0.223], in addition to a reduction in alpha 2 in the frontal (p = 0.039; d = 0.384) and parietal (p = 0.021; d = 0.520) regions after the treatment on five consecutive days. We conclude that neuromodulation protocols produced similar effects on pain reduction, but differed with respect to the changes in the alpha 2 frequency band in the frontal and parietal regions.",2020,"Statistical analysis showed a reduction in pain intensity after treatment for groups in general [F (1.28) = 8.02; p = 0.008; η 2 = 0.223], in addition to a reduction in alpha 2 in the frontal (p = 0.039; d = 0.384) and parietal (p = 0.021; d = 0.520) regions after the treatment on five consecutive days.","['women with fibromyalgia', '31 women diagnosed with fibromyalgia']","['tDCS protocols', 'Transcranial Direct Current Stimulation (tDCS', 'placebo', 'anodic stimulation']","['pain reduction', 'pain and EEG alpha-2 oscillations', 'pain intensity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",31.0,0.0633094,"Statistical analysis showed a reduction in pain intensity after treatment for groups in general [F (1.28) = 8.02; p = 0.008; η 2 = 0.223], in addition to a reduction in alpha 2 in the frontal (p = 0.039; d = 0.384) and parietal (p = 0.021; d = 0.520) regions after the treatment on five consecutive days.","[{'ForeName': 'Géssika Araújo', 'Initials': 'GA', 'LastName': 'de Melo', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, 58051-900, Brazil. gessika.fisio@gmail.com.'}, {'ForeName': 'Eliane Araújo', 'Initials': 'EA', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Physiotherapy, Federal University of Paraiba, João Pessoa, 58051-900, Brazil.'}, {'ForeName': 'Suellen Mary Marinho', 'Initials': 'SMM', 'LastName': 'Dos Santos Andrade', 'Affiliation': 'Department of Physiotherapy, Federal University of Paraiba, João Pessoa, 58051-900, Brazil.'}, {'ForeName': 'Bernardino', 'Initials': 'B', 'LastName': 'Fernández-Calvo', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, 58051-900, Brazil.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Torro', 'Affiliation': 'Department of Psychology, Federal University of Paraiba, João Pessoa, 58051-900, Brazil.'}]",Scientific reports,['10.1038/s41598-020-75861-5']
1934,33144669,Overlap in processing advantages for minimal ingroups and the self.,"Cognitive biases shape our perception of the world and our interactions with other people. Information related to the self and our social ingroups is prioritised for cognitive processing and can therefore form some of these key biases. However, ingroup biases may be elicited not only for established social groups, but also for minimal groups assigned by novel or random social categorisation. Moreover, whether these 'ingroup biases' are related to self-processing is unknown. Across three experiments, we utilised a social associative matching paradigm to examine whether the cognitive mechanisms underpinning the effects of minimal groups overlapped with those that prioritise the self, and whether minimal group allocation causes early processing advantages. We found significant advantages in response time and sensitivity (dprime) for stimuli associated with newly-assigned ingroups. Further, self-biases and ingroup-biases were positively correlated across individuals (Experiments 1 and 3). However, when the task was such that ingroup and self associations competed, only the self-advantage was detected (Experiment 2). These results demonstrate that even random group allocation quickly captures attention and enhances processing. Positive correlations between the self- and ingroup-biases suggest a common cognitive mechanism across individuals. These findings have implications for understanding how social biases filter our perception of the world.",2020,We found significant advantages in response time and sensitivity (dprime) for stimuli associated with newly-assigned ingroups.,[],[],['response time and sensitivity (dprime'],[],[],"[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0114667,We found significant advantages in response time and sensitivity (dprime) for stimuli associated with newly-assigned ingroups.,"[{'ForeName': 'Florence E', 'Initials': 'FE', 'LastName': 'Enock', 'Affiliation': 'Department of Experimental Psychology, University of Oxford, Oxford, OX2 6GG, UK. Florence.Enock@york.ac.uk.'}, {'ForeName': 'Miles R C', 'Initials': 'MRC', 'LastName': 'Hewstone', 'Affiliation': 'Department of Experimental Psychology, University of Oxford, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Lockwood', 'Affiliation': 'Department of Experimental Psychology, University of Oxford, Oxford, OX2 6GG, UK. Patricia.Lockwood@psy.ox.ac.uk.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Sui', 'Affiliation': 'School of Psychology, University of Aberdeen, Aberdeen, AB24 3RT, UK. Jie.Sui@abdn.ac.uk.'}]",Scientific reports,['10.1038/s41598-020-76001-9']
1935,33144700,The impact of early body-weight variability on long-term weight maintenance: exploratory results from the NoHoW weight-loss maintenance intervention.,"BACKGROUND
Weight-loss programmes often achieve short-term success though subsequent weight regain is common. The ability to identify predictive factors of regain early in the weight maintenance phase is crucial.
OBJECTIVE
To investigate the associations between short-term weight variability and long-term weight outcomes in individuals engaged in a weight-loss maintenance intervention.
METHODS
The study was a secondary analysis from The NoHoW trial, an 18-month weight maintenance intervention in individuals who recently lost ≥5% body weight. Eligible participants (n = 715, 64% women, BMI = 29.2 (SD 5.0) kg/m 2 , age = 45.8 (SD 11.5) years) provided body-weight data by smart scale (Fitbit Aria 2) over 18 months. Variability in body weight was calculated by linear and non-linear methods over the first 6, 9 and 12 weeks. These estimates were used to predict percentage weight change at 6, 12, and 18 months using both crude and adjusted multiple linear regression models.
RESULTS
Greater non-linear weight variability over the first 6, 9 and 12 weeks was associated with increased subsequent weight in all comparisons; as was greater linear weight variability measured over 12 weeks (up to AdjR 2 = 4.7%). Following adjustment, 6-week weight variability did not predict weight change in any model, though greater 9-week weight variability by non-linear methods was associated with increased body-weight change at 12 (∆AdjR 2 = 1.2%) and 18 months (∆AdjR 2 = 1.3%) and by linear methods at 18 months (∆AdjR 2 = 1.1%). Greater non-linear weight variability measured over 12 weeks was associated with increased weight at 12 (∆AdjR 2 = 1.4%) and 18 (∆AdjR 2 = 2.2%) months; and 12-week linear variability was associated with increased weight at 12 (∆AdjR 2 = 2.1%) and 18 (∆AdjR 2 = 3.6%) months.
CONCLUSION
Body-weight variability over the first 9 and 12 weeks of a weight-loss maintenance intervention weakly predicted increased weight at 12 and 18 months. These results suggest a potentially important role in continuously measuring body weight and estimating weight variability.",2020,"Following adjustment, 6-week weight variability did not predict weight change in any model, though greater 9-week weight variability by non-linear methods was associated with increased body-weight change at 12 (∆AdjR 2 = 1.2%) and 18 months (∆AdjR 2 = 1.3%) and by linear methods at 18 months (∆AdjR 2 = 1.1%).","['Eligible participants (n\u2009=\u2009715, 64% women, BMI\u2009=\u200929.2 (SD 5.0) kg/m 2 , age\u2009=\u200945.8 (SD 11.5) years) provided body-weight data by smart scale (Fitbit Aria 2) over 18 months', 'individuals who recently lost ≥5% body weight', 'individuals engaged in a weight-loss maintenance intervention']",[],"['weight', 'linear weight variability', 'Greater non-linear weight variability', 'Variability in body weight', 'body-weight change', 'subsequent weight']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0752253', 'cui_str': 'NRG Proteins'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",,0.0254654,"Following adjustment, 6-week weight variability did not predict weight change in any model, though greater 9-week weight variability by non-linear methods was associated with increased body-weight change at 12 (∆AdjR 2 = 1.2%) and 18 months (∆AdjR 2 = 1.3%) and by linear methods at 18 months (∆AdjR 2 = 1.1%).","[{'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Turicchi', 'Affiliation': 'Faculty of Medicine and Health, School of Psychology, University of Leeds, Leeds, UK. Psjt@leeds.ac.uk.'}, {'ForeName': 'Ruairi', 'Initials': 'R', 'LastName': ""O'Driscoll"", 'Affiliation': 'Faculty of Medicine and Health, School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lowe', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'Faculty of Medicine and Health, School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Antonio L', 'Initials': 'AL', 'LastName': 'Palmeira', 'Affiliation': 'Faculdade de Motricidade Humana, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Sofus C', 'Initials': 'SC', 'LastName': 'Larsen', 'Affiliation': 'Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region, Copenhagen, Denmark.'}, {'ForeName': 'Berit L', 'Initials': 'BL', 'LastName': 'Heitmann', 'Affiliation': 'Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region, Copenhagen, Denmark.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Stubbs', 'Affiliation': 'Faculty of Medicine and Health, School of Psychology, University of Leeds, Leeds, UK.'}]",International journal of obesity (2005),['10.1038/s41366-020-00706-0']
1936,33144770,Role of Orthoboon (glucosamine sulfate + collagen + Vitamin C): A novel host-modulating agent in the management of chronic periodontitis.,"Background
Recent trends suggest using novel host-modulating agents as a treatment strategy for chronic periodontitis. Glucosamine sulfate (GS) was proven to have anti-inflammatory actions related to its ability to suppress neutrophil functions. Orthoboon, an anti-arthritic and anti-inflammatory drug, has shown to have a positive therapeutic effect due to its constituents made of a combination of GS, Vitamin C, and collagen. The aim of the study was to evaluate the host modulatory effects of Orthoboon on periodontal status and to estimate the C reactive protein (CRP) levels before and after nonsurgical periodontal therapy (NSPT).
Materials and Methods
A total number of 40 patients with chronic periodontitis were randomly divided into two groups of 20 patients each. The test group patients ( n = 20) received 500 mg Orthoboon three times daily for 45 days. Prior to the initiation of Orthoboon, all patients in both test group and control group were subjected to Phase I periodontal therapy. CRP levels were estimated immediately after phase I therapy and 45 days after therapy. Clinical parameters including plaque index, gingival index, and bleeding index were recorded before and after NSPT for the two groups.
Results
The mean CRP levels were reduced significantly in the test group before and after administration of Orthoboon and also there were statistically significant differences in the mean CRP levels at the end of 45 days between the test group and the control group.
Conclusion
Administration of Orthoboon, i.e., GS, with a combination of Vitamin C and collagen was proved to be of a significant benefit in the test group than in the control group.",2020,"Clinical parameters including plaque index, gingival index, and bleeding index were recorded before and after NSPT for the two groups.
","['chronic periodontitis', '40 patients with chronic periodontitis']","['Glucosamine sulfate (GS', 'Orthoboon', 'nonsurgical periodontal therapy (NSPT', 'Orthoboon (glucosamine sulfate + collagen + Vitamin C']","['mean CRP levels', 'plaque index, gingival index, and bleeding index', 'C reactive protein (CRP) levels', 'CRP levels']","[{'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0017720', 'cui_str': 'Glucosamine sulfate'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.01537,"Clinical parameters including plaque index, gingival index, and bleeding index were recorded before and after NSPT for the two groups.
","[{'ForeName': 'Gautami S', 'Initials': 'GS', 'LastName': 'Penmetsa', 'Affiliation': 'Department of Periodontics and Implantology, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'Anudeep', 'Initials': 'A', 'LastName': 'Mopidevi', 'Affiliation': 'Department of Periodontics and Implantology, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'Venkata', 'Initials': 'V', 'LastName': 'Ramaraju', 'Affiliation': 'Department of Prosthodontics, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Ramachandran', 'Affiliation': 'Department of Periodontics and Implantology, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Ramesh', 'Affiliation': 'Department of Public Health Dentistry, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}]",Journal of Indian Society of Periodontology,['10.4103/jisp.jisp_645_19']
1937,33144769,A novel soft tissue cone-beam computed tomography study in the evaluation of gingival thickness associated with subepithelial connective tissue graft versus acellular dermal matrix in the management of gingival recession: A clinical study.,"Background
Dental esthetic awareness among patients led the clinicians to introduce newer materials and predictable techniques that satisfy the patients' esthetic demands.
Aim
To evaluate and compare the efficacy of subepithelial connective tissue graft (SECTG) and acellular dermal matrix (ACDM) allograft in the treatment of Millers Class I or Class II recession with the determination of gingival thickness using an impertinent method, soft tissue cone-beam computed tomography (ST-CBCT).
Materials and Methods
A split-mouth study with a total of ten patients with bilateral Millers class I or class II recession is randomly assigned by a coin toss method as Group I (SECTG) and Group II (ACDM) along with coronally advanced flap. Clinical parameters including recession height (RH), recession width (RW), probing depth, clinical attachment level (CAL), and height of keratinized tissue (HKT) were evaluated at baseline, 90 th day, and 180 th day for both groups. The thickness of keratinized tissue (TKT) was determined by most reliable, predictable and noninvasive method called ST-CBCT.
Results
Statistically significant reduction in RH and RW, gain in CAL, and increase in HKT and TKT in both Group I and Group II were seen in 90 th day and 180 th day. However, when both Group I and Group II were compared between 0 and 180 th day, the change in RH and RW, gain in CAL, and increase in HKT and TKT did not show any statistically significant change.
Conclusion
The present study suggested that root coverage with both SECTG and ACDM is very predictable procedure and it is stable for 6 months. ST-CBCT is a newer dimension in periodontal imaging and will certainly aid clinicians in the execution of various treatment modalities with increased predictability.",2020,"Statistically significant reduction in RH and RW, gain in CAL, and increase in HKT and TKT in both Group I and Group II were seen in 90 th day and 180 th day.","['gingival recession', 'ten patients with bilateral Millers class']","['subepithelial connective tissue graft (SECTG) and acellular dermal matrix (ACDM) allograft', 'coin toss method as Group I (SECTG) and Group II (ACDM) along with coronally advanced flap', 'SECTG and ACDM', 'ST-CBCT', 'subepithelial connective tissue graft versus acellular dermal matrix']","['RH and RW, gain in CAL, and increase in HKT and TKT', 'thickness of keratinized tissue (TKT', 'recession height (RH), recession width (RW), probing depth, clinical attachment level (CAL), and height of keratinized tissue (HKT', 'change in RH and RW, gain in CAL, and increase in HKT and TKT']","[{'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C3494272', 'cui_str': 'Acellular Dermal Matrix'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0524669', 'cui_str': 'Coins'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}]","[{'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",10.0,0.0191875,"Statistically significant reduction in RH and RW, gain in CAL, and increase in HKT and TKT in both Group I and Group II were seen in 90 th day and 180 th day.","[{'ForeName': 'Nimisha', 'Initials': 'N', 'LastName': 'Mithradas', 'Affiliation': 'Department of Periodontics, Thai Moogambigai Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Sudhakar', 'Affiliation': 'Department of Periodontics, Thai Moogambigai Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Lalitha T', 'Initials': 'LT', 'LastName': 'Arunachalam', 'Affiliation': 'Department of Periodontics, Thai Moogambigai Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Snophia', 'Initials': 'S', 'LastName': 'Suresh', 'Affiliation': 'Department of Periodontics, Thai Moogambigai Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Raja', 'Affiliation': 'Department of Periodontics, Thai Moogambigai Dental College and Hospital, Chennai, Tamil Nadu, India.'}]",Journal of Indian Society of Periodontology,['10.4103/jisp.jisp_508_19']
1938,33151634,The clinical effect of psychosomatic interventions on empty nose syndrome secondary to turbinate-sparing techniques: a prospective self-controlled study.,"BACKGROUND
Individuals affected by empty nose syndrome secondary to turbinate-sparing techniques (ENS-type) experience decreased productivity and lifestyle disruption owing to considerable nasal-associated discomfort. This study aimed to evaluate the effect of psychosomatic intervention on ENS-type.
METHODS
A prospective self-controlled study was conducted, and 28 patients suffering from ENS-type who met the diagnostic criteria for somatic symptom disorder (SSD) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) received cognitive and behavioral therapy (CBT) plus antidepressants. Nasal symptom burden was evaluated using the 25-item Sino-Nasal Outcome Test (SNOT-25). Somatic symptom burden, anxiety severity, and depression severity were assessed by the 25-item Patient Health Questionnaire (PHQ-15), the 9-item PHQ (PHQ-9), and the 7-item Generalized Anxiety Disorder (GAD-7) scale, respectively. Patient assessments were completed prior to treatment and 3 and 12 months after the intervention.
RESULTS
The total scores of the SNOT-25 declined posttreatment, showing a significant difference at the 3-month and 12-month follow-ups compared with the baseline scores (p < 0.001). The severity of the 5 most common subjective symptoms, including ""nose is too open,"" ""waking up at night,"" ""lack of a good night's sleep,"" ""difficulty falling asleep,"" and ""reduced concentration,"" declined significantly at 3 and 12 months posttreatment compared to baseline levels. Statistically significant changes in the PHQ-15, PHQ-9, and GAD-7 scores were observed at 3 and 12 months posttreatment compared to baseline scores (p < 0.001).
CONCLUSION
This study showed that some patients with ENS-type meeting the diagnostic criteria for SSD might benefit from psychiatric treatment.",2020,"The total scores of the SNOT-25 declined posttreatment, showing a significant difference at the 3-month and 12-month follow-ups compared with the baseline scores (p < 0.001).","['28 patients suffering from ENS-type who met the diagnostic criteria for somatic symptom disorder (SSD) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) received']","['psychosomatic interventions', 'cognitive and behavioral therapy (CBT) plus antidepressants', 'psychosomatic intervention']","['total scores', 'Somatic symptom burden, anxiety severity, and depression severity', '25-item Patient Health Questionnaire (PHQ-15), the 9-item PHQ (PHQ-9), and the 7-item Generalized Anxiety Disorder (GAD-7) scale', 'Nasal symptom burden', 'PHQ-15, PHQ-9, and GAD-7 scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4087321', 'cui_str': 'Somatic symptom disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}]",,0.0164581,"The total scores of the SNOT-25 declined posttreatment, showing a significant difference at the 3-month and 12-month follow-ups compared with the baseline scores (p < 0.001).","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Tian', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Junwu', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': ""Department of Psychology, School of Public Health, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Guangzhou Psychiatric Hospital, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Dang', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zou', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, People's Republic of China.""}]",International forum of allergy & rhinology,['10.1002/alr.22726']
1939,33144141,Control of cardiovascular risk factors with tailored recommendations: A randomized controlled trial.,"This study analyzed the efficacy of tailored recommendations to control cardiovascular risk factors at 1-year follow-up in a population-based randomized controlled trial in individuals aged 35-74 years with no history of cardiovascular disease at baseline. Total, low-density lipoprotein (LDL), and high-density lipoprotein cholesterol and systolic and diastolic blood pressure (BP) were measured at baseline and at 1-year follow-up. The primary outcome was the quantitative change in total cholesterol. To estimate the differences within and between groups, McNemar and Student t-tests were applied according to an intention-to-treat strategy. We enrolled 955 individuals [52.3% women; mean age, 50 years (standard deviation 10)]. Finally, 1 participant in each group presented a cardiovascular event and 768 were reexamined at 1-year follow-up. Intervention and control groups showed significant increases in total cholesterol [5.49 (standard deviation 1.02) to 5.56 (1.06) mmol/L and 5.34 (0.94) to 5.43 (0.93) mmol/L, respectively]. Men in the intervention group showed significant decreases in systolic and diastolic BP [117.2 (14.6) to 115.6 mmHg (14.1) and 77.9 (9.7) to 76.5 mmHg (9.7), respectively]; no changes were found in the rates of total cholesterol <5.2 mmol/L and LDL cholesterol <3.0 mmol/L. In the control group, both values were significantly decreased (43.5 to 36.4% and 26.4 to 20.8%, respectively) in men. In the stratified analysis, women showed no differences in any of the outcomes. In conclusion, an intervention with tailored recommendations increased mean total cholesterol values. The intervention effect was higher in men who maintained blood lipids at optimal levels and had decreased BP values.",2020,"Intervention and control groups showed significant increases in total cholesterol [5.49 (standard deviation 1.02) to 5.56 (1.06) mmol/L and 5.34 (0.94) to 5.43 (0.93) mmol/L, respectively].","['We enrolled 955 individuals [52.3% women; mean age, 50\u202fyears (standard deviation 10', 'individuals aged 35-74\u202fyears with no history of cardiovascular disease at baseline']",[],"['systolic and diastolic BP', 'total cholesterol', 'rates of total cholesterol', 'Total, low-density lipoprotein (LDL), and high-density lipoprotein cholesterol and systolic and diastolic blood pressure (BP', 'cardiovascular event', 'BP values', 'quantitative change in total cholesterol', 'mean total cholesterol values']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",[],"[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",955.0,0.122144,"Intervention and control groups showed significant increases in total cholesterol [5.49 (standard deviation 1.02) to 5.56 (1.06) mmol/L and 5.34 (0.94) to 5.43 (0.93) mmol/L, respectively].","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Barroso', 'Affiliation': 'Cardiovascular Epidemiology and Genetics Research Group, IMIM-Hospital del Mar Research Institute, Barcelona, Spain; Department of Pediatrics, Obstetrics, Gynecology and Preventive Medicine, School of Medicine, Autonomous University of Barcelona, Spain; Eastfield Health, Ashburton, New Zealand.'}, {'ForeName': 'M Dolors', 'Initials': 'MD', 'LastName': 'Zomeño', 'Affiliation': 'Cardiovascular Risk and Nutrition, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain; School of Health Sciences, Blanquerna-Ramon Llull University, Barcelona, Spain.'}, {'ForeName': 'Jorge L', 'Initials': 'JL', 'LastName': 'Díaz', 'Affiliation': 'Cardiovascular Epidemiology and Genetics Research Group, IMIM-Hospital del Mar Research Institute, Barcelona, Spain; Docent Unit Preventive Medicine and Public Health Parc de Salut Mar, Barcelona Public Health Agency, Pompeu-Fabra University, Barcelona, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pérez', 'Affiliation': 'Regicor Research Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain; Consortium for Biomedical Research in Cardiovascular Disease (CIBERCV), Barcelona, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Martí-Lluch', 'Affiliation': 'ISV Girona, IDIAP Jordi Gol, Girona, Catalunya, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cordón', 'Affiliation': 'Primary Care Services, Catalan Institute of Health, Girona, Catalunya, Spain.; Department of Medical Sciences, School of Medicine, University of Girona, Spain.'}, {'ForeName': 'Rafel', 'Initials': 'R', 'LastName': 'Ramos', 'Affiliation': 'ISV Girona, IDIAP Jordi Gol, Girona, Catalunya, Spain; Department of Medical Sciences, School of Medicine, University of Girona, Spain; Girona Biomedical Research Institute, Girona, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Cabezas', 'Affiliation': 'Public Health Agency of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Salvador', 'Affiliation': 'Public Health Agency of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Conxa', 'Initials': 'C', 'LastName': 'Castell', 'Affiliation': 'Public Health Agency of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schröder', 'Affiliation': 'Cardiovascular Risk and Nutrition, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain; Consortium for Biomedical Research in Epidemiology and Public Health (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Grau', 'Affiliation': 'Cardiovascular Epidemiology and Genetics Research Group, IMIM-Hospital del Mar Research Institute, Barcelona, Spain; Consortium for Biomedical Research in Epidemiology and Public Health (CIBERESP), Barcelona, Spain; Serra Húnter Fellow, Department of Medicine, University of Barcelona, Barcelona, Spain. Electronic address: mgrau@imim.es.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106302']
1940,33144188,Novel imaging-based approaches for predicting the hepatic venous pressure gradient in a porcine model of liver cirrhosis and portal hypertension.,"AIMS
Hepatic venous pressure gradient (HVPG) is critical for staging and prognosis prediction of portal hypertension (PH). However, HVPG measurement has limitations (e.g., invasiveness). This study examined the value of non-invasive, imaging-based approaches including magnetic resonance elastography (MRE) and intravoxel incoherent motion (IVIM) diffusion-weighted imaging (DWI) for the prediction of HVPG in a porcine model of liver cirrhosis and PH.
MAIN METHODS
Male Bama miniature pigs were used to establish a porcine model of liver cirrhosis and PH induced by embolization. They were randomly assigned to an experimental group (n = 12) and control group (n = 3). HVPG was examined before and after transjugular intrahepatic portosystemic shunt (TIPS). MRE and IVIM-DWI were performed to obtain quantitative parameters including liver stiffness (LS) in MRE, tissue diffusivity (D), pseudo-diffusion coefficient (D*), and perfusion fraction (f) in IVIM-DWI. The correlation between HVPG and the parameters was assessed.
KEY FINDINGS
LS values were significantly greater in the experimental group, while f values were significantly decreased at 4, 8, and 12 weeks after embolization compared to the control group. Furthermore, HVPG was significantly lower immediately after versus before TIPS. In parallel, LS and f values showed significant alterations after TIPS, and these changes were consistent with a reduction in HVPG. Spearman analysis revealed a significant correlation between the parameters (LS and f) and HVPG. The equation was eventually generated for prediction of HVPG.
SIGNIFICANCE
The findings show a good correlation between HVPG and the quantitative parameters; thus, imaging-based techniques have potential as non-invasive methods for predicting HVPG.",2020,"In parallel, LS and f values showed significant alterations after TIPS, and these changes were consistent with a reduction in HVPG.","['Male Bama miniature pigs', 'liver cirrhosis and portal hypertension']","['transjugular intrahepatic portosystemic shunt (TIPS', 'magnetic resonance elastography (MRE) and intravoxel incoherent motion (IVIM) diffusion-weighted imaging (DWI', 'Hepatic venous pressure gradient (HVPG']","['MRE and IVIM-DWI', 'HVPG', 'liver stiffness (LS) in MRE, tissue diffusivity (D), pseudo-diffusion coefficient (D*), and perfusion fraction (f) in IVIM-DWI']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0020541', 'cui_str': 'Portal hypertension'}]","[{'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C1518156', 'cui_str': 'Magnetic resonance elastography'}, {'cui': 'C0542044', 'cui_str': 'Incoherent'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0598801', 'cui_str': 'Diffusion weighted magnetic resonance imaging'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C4049263', 'cui_str': 'Hepatic venous pressure gradient'}]","[{'cui': 'C1518156', 'cui_str': 'Magnetic resonance elastography'}, {'cui': 'C0542044', 'cui_str': 'Incoherent'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C4049263', 'cui_str': 'Hepatic venous pressure gradient'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",,0.0213671,"In parallel, LS and f values showed significant alterations after TIPS, and these changes were consistent with a reduction in HVPG.","[{'ForeName': 'Yujia', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Shengjing Hospital, China Medical University, Shenyang 110004, China.'}, {'ForeName': 'Deshuo', 'Initials': 'D', 'LastName': 'Dong', 'Affiliation': 'Department of Radiology, First Affiliated Hospital of Dalian Medical University, Dalian 116011, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Gong', 'Affiliation': 'Department of Radiology, Shengjing Hospital, China Medical University, Shenyang 110004, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Department of Interventional Radiation, Anstell Group Hospital, Anshan, Liaoning, China.'}, {'ForeName': 'Qiyong', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Radiology, Shengjing Hospital, China Medical University, Shenyang 110004, China,. Electronic address: guo_qiyongcmu@163.com.'}]",Life sciences,['10.1016/j.lfs.2020.118710']
1941,33144213,New insights from SONAR indicate adding sodium glucose co-transporter 2 inhibitors to an endothelin receptor antagonist mitigates fluid retention and enhances albuminuria reduction.,"The diuretic effects achieved with sodium glucose co-transporter 2 inhibitors (SGLT2i) may offset fluid retaining effects of the endothelin receptor antagonist (ERA) atrasentan while effects on albuminuria and kidney protection of both drug classes may be complimentary due to distinct mechanisms of action. Here, post-hoc analysis of the SONAR trial, in patients with type 2 diabetes and chronic kidney disease, show that six-weeks treatment with combined SGLT2i/atrasentan versus atrasentan alone decreased body weight, a surrogate for fluid retention, and further decreased albuminuria. Thus, these promising findings support future clinical studies to characterize the long-term efficacy and safety of combined SGLT2i/ ERA treatment.",2020,The diuretic effects achieved with sodium glucose co-transporter 2 inhibitors (SGLT2i) may offset fluid retaining effects of the endothelin receptor antagonist (ERA) atrasentan while effects on albuminuria and kidney protection of both drug classes may be complimentary due to distinct mechanisms of action.,['patients with type 2 diabetes and chronic kidney disease'],"['sodium glucose co-transporter 2 inhibitors (SGLT2i', 'combined SGLT2i/atrasentan versus atrasentan']",['body weight'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0935914', 'cui_str': 'Atrasentan'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.0272236,The diuretic effects achieved with sodium glucose co-transporter 2 inhibitors (SGLT2i) may offset fluid retaining effects of the endothelin receptor antagonist (ERA) atrasentan while effects on albuminuria and kidney protection of both drug classes may be complimentary due to distinct mechanisms of action.,"[{'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': ''}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Kohan', 'Affiliation': ''}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': ''}]",Kidney international,['10.1016/j.kint.2020.09.026']
1942,33144226,Opioid Requirement After Rotator Cuff Repair is Low With a Multimodal Approach to Pain.,"BACKGROUND
Current practices may aim to blunt rather than understand postoperative pain. Perhaps the most common serious complication of arthroscopic rotator cuff repair (ARCR) is persistence of opiate medication intake. Patients still receive upwards of 80 oxycodone 5mg pills, or 600 morphine milligram equivalents (MMEs), leading over 20% of opioid-naïve subjects to continue to fill opioid prescriptions beyond 180 days post-surgery. Developing evidence-based guidelines for narcotic prescription following ARCR presents an opportunity for orthopedic surgeons to address the opioid epidemic.
PURPOSE
The purpose of this study was 1) to prospectively determine the requirements for opiate medications following ARCR, and 2) to create an evidence-based guideline for postoperative prescription, in contrast to the anecdotal or expert panel recommendations that currently exist. We further investigated whether a liposomal bupivacaine (LB) interscalene never block (ISNB) would reduce pain and opiate consumption compared to standard bupivacaine ISNB (control) for ARCR.
STUDY DESIGN
Level II Randomized Controlled Clinical Trial METHODS: The study enrolled 100 patients undergoing primary ARCR surgery. Patients were provided with postoperative ""Pain Journals"" to document their daily pain on a numerical-rating scale (NRS), satisfaction with pain management using the Likert Scale, and to track their daily oxycodone 5mg pill consumption during the 14-day postoperative period. Enrolled patients were further randomized to receiving an LB (experimental) or standard bupivacaine (control) ISNB.
RESULTS
77% of all patients required fewer than 15 pills postoperatively. The LB group consumed an average of 1.7 fewer pills (13.0 MMEs) on postoperative day (POD) 1 (P= 0.02) and reported statistically lower pain during PODs 1 and 2 (P=0.01 and P= 0.006), as well as cumulatively throughout the study period (P= 0.03). In addition, LB patients remained opioid-free at a higher rate (44% vs. 15% in controls, P= 0.03).
CONCLUSION
With a multimodal approach, the majority of patients undergoing ARCR can manage postoperative pain with 15 or fewer oxycodone 5 mg tabs (112.5 MMEs) and maintain a high degree of satisfaction. The addition of a LB ISNB may further reduce the consumption of postoperative narcotics compared to a standard ISNB. This study provides evidence that may be used for surgeon guidelines in the effort to reduce opioid prescriptions following ARCR.
LEVEL OF EVIDENCE
Level II; Randomized Controlled Trial; Treatment Study.",2020,"The LB group consumed an average of 1.7 fewer pills (13.0 MMEs) on postoperative day (POD) 1 (P= 0.02) and reported statistically lower pain during PODs 1 and 2 (P=0.01 and P= 0.006), as well as cumulatively throughout the study period (P= 0.03).",['100 patients undergoing primary ARCR surgery'],"['liposomal bupivacaine (LB) interscalene never block (ISNB', 'LB (experimental) or standard bupivacaine (control) ISNB', 'oxycodone 5mg pills, or 600 morphine milligram equivalents (MMEs), leading over 20% of opioid-naïve subjects to continue to fill opioid prescriptions beyond 180 days post-surgery', 'oxycodone', 'bupivacaine ISNB (control', 'arthroscopic rotator cuff repair (ARCR', 'Opioid Requirement']","['consumption of postoperative narcotics', 'numerical-rating scale (NRS), satisfaction with pain management', 'pain and opiate consumption', 'postoperative pain', 'pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0589495', 'cui_str': 'Interscalene approach'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",100.0,0.213047,"The LB group consumed an average of 1.7 fewer pills (13.0 MMEs) on postoperative day (POD) 1 (P= 0.02) and reported statistically lower pain during PODs 1 and 2 (P=0.01 and P= 0.006), as well as cumulatively throughout the study period (P= 0.03).","[{'ForeName': 'Nikhil K', 'Initials': 'NK', 'LastName': 'Mandava', 'Affiliation': 'Orthopaedic & Neurosurgery Specialists, Greenwich, CT, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Sethi', 'Affiliation': 'Orthopaedic & Neurosurgery Specialists, Greenwich, CT, USA. Electronic address: sethi@onsmd.com.'}, {'ForeName': 'Howard D', 'Initials': 'HD', 'LastName': 'Routman', 'Affiliation': 'Atlantis Orthopaedics, Palm Beach Gardens, FL, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Liddy', 'Affiliation': 'Orthopaedic & Neurosurgery Specialists, Greenwich, CT, USA.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Haidamous', 'Affiliation': 'Southern Oregon Orthopaedics, Medford, OR, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Denard', 'Affiliation': 'Southern Oregon Orthopaedics, Medford, OR, USA.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.09.032']
1943,33144269,Direct Comparison of Efficacy of the Motor Cortical Plasticity Induction and the Interindividual Variability between TBS and QPS.,"BACKGROUND
Theta burst stimulation (TBS) and quadripulse stimulation (QPS) are known to induce synaptic plasticity in humans. There have been no head-to-head comparisons of the efficacy and variability between TBS and QPS.
OBJECTIVE
To compare the efficacy and interindividual variability between the original TBS and QPS protocols. We hypothesized that QPS would be more effective and less variable than TBS.
METHODS
Forty-six healthy subjects participated in this study. Thirty subjects participated in the main comparison experiment, and the other sixteen subjects participated in the experiment to obtain natural variation in motor-evoked potentials. The facilitatory effects were compared between intermittent TBS (iTBS) and QPS5, and the inhibitory effects were compared between continuous TBS (cTBS) and QPS50. The motor-evoked potential amplitudes elicited by transcranial magnetic stimulation over the primary motor cortex were measured before the intervention and every 5 min after the intervention for one hour. To investigate the interindividual variability, the responder/nonresponder/opposite-responder rates were also analyzed.
RESULTS
The facilitatory effects of QPS5 were greater than those of iTBS, and the inhibitory effects of QPS50 were much stronger than those of cTBS. The responder rate of QPS was significantly higher than that of TBS. QPS had a smaller number of opposite responders than TBS.
CONCLUSION
QPS is more effective and stable for synaptic plasticity induction than TBS.",2020,The motor-evoked potential amplitudes elicited by transcranial magnetic stimulation over the primary motor cortex were measured before the intervention and every 5 min after the intervention for one hour.,"['Forty-six healthy subjects participated in this study', 'Thirty subjects participated in the main comparison experiment, and the other sixteen subjects participated in the experiment to obtain natural variation in motor-evoked potentials']","['Theta burst stimulation (TBS) and quadripulse stimulation (QPS', 'QPS']","['inhibitory effects of QPS50', 'responder rate of QPS']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",30.0,0.0299469,The motor-evoked potential amplitudes elicited by transcranial magnetic stimulation over the primary motor cortex were measured before the intervention and every 5 min after the intervention for one hour.,"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Tiksnadi', 'Affiliation': 'Department of Neurology, Fukushima Medical University, Fukushima, Japan; Department of Neurology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia. Electronic address: amtiks@gmail.com.'}, {'ForeName': 'Takenobu', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Department of Neurology, Fukushima Medical University, Fukushima, Japan; Department of Neurology, Tottori Prefectural Kousei Hospital, Tottori, Japan.'}, {'ForeName': 'Winnugroho', 'Initials': 'W', 'LastName': 'Wiratman', 'Affiliation': 'Department of Neurology, Fukushima Medical University, Fukushima, Japan; Department of Neurology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Neurology, Mitsui Memorial Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Ugawa', 'Affiliation': 'Department of Neurology, Fukushima Medical University, Fukushima, Japan; Department of Human Neurophysiology, Fukushima Medical University, Fukushima, Japan.'}]",Brain stimulation,['10.1016/j.brs.2020.10.014']
1944,33144481,Changing Patterns of Distant Metastasis in Patients With Lower Rectal Cancer Undergoing Intraoperative Radiotherapy.,"BACKGROUND/AIM
Local radiotherapy for primary tumors may increase the incidence of distant metastasis. However, the patterns of target organs have not been clarified yet.
PATIENTS AND METHODS
In our randomized controlled trial examining the oncological efficacy of intraoperative radiotherapy (IORT) for advanced lower rectal cancer, the details of the metastatic organs were evaluated.
RESULTS
In the IORT group (38 patients), 2 patients had metastasis in the liver and lung simultaneously, 9 in the liver, and 4 in the lung. In the control group (38 patients), 3 had metastasis in the lung, and 2 in the liver. The IORT group tended to have liver metastases more frequently (p=0.058). Among patients with liver metastases, distant metastasis-free intervals were significantly shorter in the IORT group, however, no significant difference was observed among patients with lung metastases.
CONCLUSION
After curative rectal cancer surgery with IORT, liver metastasis may be increased and accelerated.",2020,"Among patients with liver metastases, distant metastasis-free intervals were significantly shorter in the IORT group, however, no significant difference was observed among patients with lung metastases.
","['Patients With Lower Rectal Cancer Undergoing Intraoperative Radiotherapy', 'advanced lower rectal cancer']","['Local radiotherapy', 'IORT', 'intraoperative radiotherapy (IORT']",['distant metastasis-free intervals'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}]","[{'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.0841496,"Among patients with liver metastases, distant metastasis-free intervals were significantly shorter in the IORT group, however, no significant difference was observed among patients with lung metastases.
","[{'ForeName': 'Tadahiko', 'Initials': 'T', 'LastName': 'Masaki', 'Affiliation': 'Department of Surgery, Kyorin University, Tokyo, Japan masaki@ks.kyorin-u.ac.jp.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Surgery, Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Tomokazu', 'Initials': 'T', 'LastName': 'Kishiki', 'Affiliation': 'Department of Surgery, Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Kojima', 'Affiliation': 'Department of Surgery, Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Tonari', 'Affiliation': 'Department of Radiation Oncology, Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Aso', 'Affiliation': 'Department of Surgery, Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Beniya', 'Affiliation': 'Department of Surgery, Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Iioka', 'Affiliation': 'Department of Surgery, Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Wakamatsu', 'Affiliation': 'Department of Surgery, Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Sunami', 'Affiliation': 'Department of Surgery, Kyorin University, Tokyo, Japan.'}]","In vivo (Athens, Greece)",['10.21873/invivo.12212']
1945,33144512,"Fatal and non-fatal events within 14 days after early, intensive mobilization post stroke.","OBJECTIVE
This tertiary analysis from AVERT examined fatal and non-fatal Serious Adverse Events (SAEs) at 14 days.
METHOD
AVERT was a prospective, parallel group, assessor blinded, randomized international clinical trial comparing mobility training commenced <24 hours post stroke, termed very early mobilization (VEM) to usual care (UC). Primary outcome was assessed at 3 months. Included: Patients with ischaemic and haemorrhagic stroke within 24 hours of onset. Treatment with thrombolytics allowed. Excluded: Patients with severe premorbid disability and/or comorbidities. Interventions continued for 14 days or hospital discharge if less. The primary early safety outcome was fatal SAEs within 14 days. Secondary outcomes were non-fatal SAEs classified as neurologic, immobility-related, and other. Mortality influences were assessed using binary logistic regression adjusted for baseline stroke severity (NIHSS) and age.
RESULTS
2,104 participants were randomized to VEM (n = 1,054) or UC (n = 1,050) with a median age of 72 years (IQR 63-80) and NIHSS 7 (IQR 4-12). By 14 days, 48 had died in VEM, 32 in UC, age and stroke severity adjusted Odds Ratio of 1.76 (95% CI 1.06-2.92, p = 0.029). Stroke progression was more common in VEM. Exploratory subgroup analyses showed higher odds of death in intracerebral haemorrhage and >80 years subgroups, but there was no significant treatment by subgroup interaction. No difference in non-fatal SAEs found.
CONCLUSION
While the overall case fatality at 14 days post-stroke was only 3.8%, mortality adjusted for age and stroke severity was increased with high dose, intensive training compared to usual care. Stroke progression was more common in VEM.
CLASSIFICATION OF EVIDENCE
This study provides Class I evidence that very early mobilization increases mortality at 14 days post stroke.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry, ACTRN12606000185561.",2020,"While the overall case fatality at 14 days post-stroke was only 3.8%, mortality adjusted for age and stroke severity was increased with high dose, intensive training compared to usual care.","['2,104 participants', 'Included: Patients with ischaemic and haemorrhagic stroke within 24 hours of onset', 'Excluded: Patients with severe premorbid disability and/or comorbidities']","['VEM', 'UC', 'mobility training commenced <24 hours post stroke, termed very early mobilization (VEM) to usual care (UC']","['mortality adjusted for age and stroke severity', 'fatal SAEs', 'mortality', 'death in intracerebral haemorrhage', 'Fatal and non-fatal events', 'Stroke progression', 'non-fatal SAEs classified as neurologic, immobility-related, and other']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0231441', 'cui_str': 'Immobile'}]",2104.0,0.374117,"While the overall case fatality at 14 days post-stroke was only 3.8%, mortality adjusted for age and stroke severity was increased with high dose, intensive training compared to usual care.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bernhardt', 'Affiliation': 'Stroke Theme, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Australia julie.bernhardt@florey.edu.au.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Borschmann', 'Affiliation': 'Stroke Theme, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Australia.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Collier', 'Affiliation': 'Stroke Theme, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Australia.'}, {'ForeName': 'Amanda G', 'Initials': 'AG', 'LastName': 'Thrift', 'Affiliation': 'Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Langhorne', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': ""Nursing Research Institute, St Vincent's Health Australia, Sydney and Australian Catholic University, Darlinghurst, Australia.""}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Westmead Clinical School, University of Sydney, Australia.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Dewey', 'Affiliation': 'Stroke Theme, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Said', 'Affiliation': 'Physiotherapy, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Department of Medicine Austin Health, University of Melbourne, Heidelberg, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Ellery', 'Affiliation': 'Stroke Theme, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bladin', 'Affiliation': 'Ambulance Victoria, Florey Institute of Neuroscience and Mental Health, Heidelberg, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health, Curtin University, Perth.'}, {'ForeName': 'Judith H', 'Initials': 'JH', 'LastName': 'Frayne', 'Affiliation': 'Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Velandai', 'Initials': 'V', 'LastName': 'Srikanth', 'Affiliation': 'Peninsula Health & Peninsula Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Read', 'Affiliation': 'Faculty of Medicine, The University of Queensland, Herston, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'University of Melbourne, Melbourne Brain Centre, Parkville, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000011106']
1946,33144526,Innovative customized CAD/CAM nickel-titanium lingual retainer versus standard stainless-steel lingual retainer: A randomized controlled trial.,"Objective
To compare computer-aided design and computer-aided manufacturing (CAD/CAM) customized nitinol retainers with standard stainlesssteel fixed retainers over a 12-month study period.
Methods
This randomized controlled trial (RCT) was conducted on 62 patients randomly allocated to a control group that received stainless-steel retainers or a test group that received customized CAD/CAM nickel-titanium retainers. Four time points were defined: retainer placement (T0) and 1-month (T1), 6-month (T2), and 12-month (T3) follow-up appointments. At each time point, Little's irregularity index (LII) (primary endpoint) and dental stability measurements such as intercanine width were recorded in addition to assessment of periodontal parameters. Radiological measurements such as the incisor mandibular plane angle (IMPA) were recorded at T0 and T3. Failure events (wire integrity or debonding) were assessed at each time point.
Results
From T0 to T3, LII and other dental measurements showed no significant differences between the two groups. The data for periodontal parameters remained stable over the study period, except for the gingival index, which was slightly, but significantly, higher in the test group at T3 ( p = 0.039). The IMPA angle showed no intergroup difference. The two groups showed no significant difference in debonding events.
Conclusions
This RCT conducted over a 12-month period demonstrated no significant difference between customized CAD/CAM nickel-titanium lingual retainers and standard stainlesssteel lingual retainers in terms of dental anterior stability and retainer survival. Both retainers eventually appeared to be equally effective in maintaining periodontal health.",2020,"Results
From T0 to T3, LII and other dental measurements showed no significant differences between the two groups.",['62 patients randomly allocated to a'],"['control group that received stainless-steel retainers or a test group that received customized CAD/CAM nickel-titanium retainers', 'Innovative customized CAD/CAM nickel-titanium lingual retainer versus standard stainless-steel lingual retainer', 'computer-aided design and computer-aided manufacturing (CAD/CAM) customized nitinol retainers with standard stainlesssteel fixed retainers']","['debonding events', 'dental anterior stability and retainer survival', 'Failure events (wire integrity or debonding', 'incisor mandibular plane angle (IMPA', 'irregularity index (LII) (primary endpoint) and dental stability measurements such as intercanine width']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0242919', 'cui_str': 'Orthodontic retainer'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162517', 'cui_str': 'Computer-Assisted Design'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0162516', 'cui_str': 'Computer-Assisted Manufacturing'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0242919', 'cui_str': 'Orthodontic retainer'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C4039613', 'cui_str': 'Mandibular plane angle'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0487742', 'cui_str': 'Width'}]",62.0,0.1079,"Results
From T0 to T3, LII and other dental measurements showed no significant differences between the two groups.","[{'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Gelin', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, University Hospital of Liège, Liège, Belgium.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Seidel', 'Affiliation': 'Department of Biostatistics and Medico-economic Information, University Hospital of Liège, University of Liège, Liège, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Bruwier', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, University Hospital of Liège, Liège, Belgium.'}, {'ForeName': 'Adelin', 'Initials': 'A', 'LastName': 'Albert', 'Affiliation': 'Department of Biostatistics and Medico-economic Information, University Hospital of Liège, University of Liège, Liège, Belgium.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Charavet', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, University Hospital of Liège, Liège, Belgium.'}]",Korean journal of orthodontics,['10.4041/kjod.2020.50.6.373']
1947,33144537,"Shock wave lithotripsy deteriorates male sexual functions related to the treatment-driven anxiety: A prospective, non-randomized, self-controlled study.","OBJECTIVES
This study aims to investigatel ongitudinal changes in sexual functions (SF), anxiety status, and health-related quality of life (HRQoL) after shock wave lithotripsy (SWL) in male urolithiasis patients. METHODS: Between February 2015 and April 2017, 85 consecutive male patients with kidney or ureter stones and treated with SWL were included. Patients were evaluated for SF, anxiety status, and HRQoL with questionnaire forms before and at the third month after SWL. Correlation between baseline and third-month scores of International Index of Erectile Function-15 (IIEF-15) subdomains and anxiety was evaluated. Uni- and multivariable linear regression analyses were used to identify changes in IIEF-15 subdomain scores at three months. RESULTS: Mean age was 42.80 ± 9.42 years. Significantly decreased IIEF-15 subdomain scores, increased anxiety and Short Form-36 (SF-36) subdomain scores were achieved at three months (p<0.05, for each). The baseline median values of erectile function (IIEFEF), orgasmic function (IIEF-OF), sexual desire (IIEF-SD), intercourse satisfaction (IIEF-IS), and overall satisfaction (IIEF-OS) were 26, 9, 8, 12, and 8, respectively. The same scores were 26, 9, 6, 9, and 8 at month 3, respectively. According to multivariable analysis, the difference in Beck Anxiety Inventory (BAI) scores was an independent risk factor for both changing in IIEF-SD and IIEF-IS (b= -0.094, 95%CI: -0.179 - -0.009, p=0.030 and b= -0.197, 95%CI: -0.350 - -0.044, p=0.012, respectively). The difference in the State Anxiety (STAISA) scores was an independent risk factor for changing in IIEF-IS (b= -0.075, 95%CI: -0.146 - -0.004,p=0.039). CONCLUSIONS: SWL may lead to impaired SF related to treatment-driven anxiety and significantly improve HRQoL of male patients in short term.",2020,"Significantly decreased IIEF-15 subdomain scores, increased anxiety and Short Form-36 (SF-36) subdomain scores were achieved at three months (p<0.05, for each). ","['male urolithiasis patients', 'Mean age was 42.80 ± 9.42 years', 'Between February 2015 and April 2017, 85 consecutive male patients with kidney or ureter stones and treated with SWL were included']","['shock wave lithotripsy (SWL', '95%CI', 'Shock wave lithotripsy']","['baseline median values of erectile function (IIEFEF), orgasmic function (IIEF-OF), sexual desire (IIEF-SD), intercourse satisfaction (IIEF-IS), and overall satisfaction (IIEF-OS', 'State Anxiety (STAISA) scores', 'BAI) scores', 'Beck Anxiety Inventory', 'SF, anxiety status, and HRQoL with questionnaire', 'IIEF-15 subdomain scores, increased anxiety and Short Form-36 (SF-36) subdomain scores', 'International Index of Erectile Function-15 (IIEF-15) subdomains and anxiety', 'IIEF-15 subdomain scores', 'sexual functions (SF), anxiety status, and health-related quality of life (HRQoL']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0451641', 'cui_str': 'Urolithiasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}]",85.0,0.0453191,"Significantly decreased IIEF-15 subdomain scores, increased anxiety and Short Form-36 (SF-36) subdomain scores were achieved at three months (p<0.05, for each). ","[{'ForeName': 'Nejdet', 'Initials': 'N', 'LastName': 'Karsiyakali', 'Affiliation': 'Department of Urology. University of Health Sciences. Istanbul Training and Research Hospital. Istanbul. Turkey.'}, {'ForeName': 'Erkan', 'Initials': 'E', 'LastName': 'Erkan', 'Affiliation': 'Department of Urology. University of Health Sciences. Istanbul Training and Research Hospital. Istanbul. Turkey.'}, {'ForeName': 'Ugur', 'Initials': 'U', 'LastName': 'Yucetas', 'Affiliation': 'Department of Urology. University of Health Sciences. Istanbul Training and Research Hospital. Istanbul. Turkey.'}, {'ForeName': 'Hikmet', 'Initials': 'H', 'LastName': 'Koseoglu', 'Affiliation': 'Department of Urology. University of Health Sciences. Istanbul Training and Research Hospital. Istanbul. Turkey.'}, {'ForeName': 'Huseyin Aytac', 'Initials': 'HA', 'LastName': 'Ates', 'Affiliation': 'Department of Urology. Gebze Fatih State Hospital. Kocaeli. Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Kadihasanoglu', 'Affiliation': 'Department of Urology. University of Health Sciences. Istanbul Training and Research Hospital. Istanbul. Turkey.'}, {'ForeName': 'Mahmut Gokhan', 'Initials': 'MG', 'LastName': 'Toktas', 'Affiliation': 'Department of Urology. University of Health Sciences. Istanbul Training and Research Hospital. Istanbul. Turkey.'}]",Archivos espanoles de urologia,[]
1948,33144911,The Effect of Implementing Teledermatology in Patients Presenting with Cellulitis Versus Pseudocellulitis in an Academic Emergency Department Setting: A Pilot Study.,"There is a shortage of dermatologists available to see hospitalized patients, especially for urgent evaluations such as in the emergency department setting. The use of teledermatology in the emergency setting was studied for patients presenting to the emergency department with symptoms of or a diagnosis of cellulitis. Thirty patients were enrolled and randomized to a teledermatology note being placed in their chart versus control patients undergoing standard care. Although randomized, in this small pilot study, the locations of involvement were unbalanced across treatment groups. The mean length of stay was slightly longer in the group randomized to teledermatology; however, this was largely related to the unbalanced number of patients presenting with bilateral and lower extremity complaints in the teledermatology group. This study provides important preliminary data for future studies, including ensuring appropriate balancing of locations of involvement, a larger sample size, and more rigid entry criteria.",2020,"The mean length of stay was slightly longer in the group randomized to teledermatology; however, this was largely related to the unbalanced number of patients presenting with bilateral and lower extremity complaints in the teledermatology group.","['Patients Presenting with Cellulitis Versus Pseudocellulitis in an Academic Emergency Department Setting', 'patients presenting to the emergency department with symptoms of or a diagnosis of cellulitis', 'Thirty patients']","['Implementing Teledermatology', 'teledermatology note being placed in their chart versus control patients undergoing standard care']","['extremity complaints', 'mean length of stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",30.0,0.0261989,"The mean length of stay was slightly longer in the group randomized to teledermatology; however, this was largely related to the unbalanced number of patients presenting with bilateral and lower extremity complaints in the teledermatology group.","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Wells', 'Affiliation': 'Drs. Wells, Tian, and Gupta are with The Ohio State University College of Medicine in Columbus, Ohio.'}, {'ForeName': 'Preeta', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Drs. Wells, Tian, and Gupta are with The Ohio State University College of Medicine in Columbus, Ohio.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Tian', 'Affiliation': 'Drs. Wells, Tian, and Gupta are with The Ohio State University College of Medicine in Columbus, Ohio.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Adkins', 'Affiliation': 'Drs. Wells, Tian, and Gupta are with The Ohio State University College of Medicine in Columbus, Ohio.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Kaffenberger', 'Affiliation': 'Drs. Wells, Tian, and Gupta are with The Ohio State University College of Medicine in Columbus, Ohio.'}]",The Journal of clinical and aesthetic dermatology,[]
1949,33145042,Study on automatic detection and classification of breast nodule using deep convolutional neural network system.,"Backgrounds
Conventional ultrasound manual scanning and artificial diagnosis approaches in breast are considered to be operator-dependence, slight slow and error-prone. In this study, we used Automated Breast Ultrasound (ABUS) machine for the scanning, and deep convolutional neural network (CNN) technology, a kind of Deep Learning (DL) algorithm, for the detection and classification of breast nodules, aiming to achieve the automatic and accurate diagnosis of breast nodules.
Methods
Two hundred and ninety-three lesions from 194 patients with definite pathological diagnosis results (117 benign and 176 malignancy) were recruited as case group. Another 70 patients without breast diseases were enrolled as control group. All the breast scans were carried out by an ABUS machine and then randomly divided into training set, verification set and test set, with a proportion of 7:1:2. In the training set, we constructed a detection model by a three-dimensionally U-shaped convolutional neural network (3D U-Net) architecture for the purpose of segment the nodules from background breast images. Processes such as residual block, attention connections, and hard mining were used to optimize the model while strategies of random cropping, flipping and rotation for data augmentation. In the test phase, the current model was compared with those in previously reported studies. In the verification set, the detection effectiveness of detection model was evaluated. In the classification phase, multiple convolutional layers and fully-connected layers were applied to set up a classification model, aiming to identify whether the nodule was malignancy.
Results
Our detection model yielded a sensitivity of 91% and 1.92 false positive subjects per automatically scanned imaging. The classification model achieved a sensitivity of 87.0%, a specificity of 88.0% and an accuracy of 87.5%.
Conclusions
Deep CNN combined with ABUS maybe a promising tool for easy detection and accurate diagnosis of breast nodule.",2020,"The classification model achieved a sensitivity of 87.0%, a specificity of 88.0% and an accuracy of 87.5%.
","['70 patients without breast diseases were enrolled as control group', 'Two hundred and ninety-three lesions from 194 patients with definite pathological diagnosis results (117 benign and 176 malignancy']",['Automated Breast Ultrasound (ABUS) machine'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006145', 'cui_str': 'Disorder of breast'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0080264', 'cui_str': 'Ultrasonography of breast'}, {'cui': 'C0336779', 'cui_str': 'Machine'}]",[],194.0,0.0154379,"The classification model achieved a sensitivity of 87.0%, a specificity of 88.0% and an accuracy of 87.5%.
","[{'ForeName': 'Feiqian', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Ultrasound, The First Affiliated Hospital of Xi'an Jiaotong University, China.""}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""National Engineering Lab for Big Data Analytics, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Yuan', 'Affiliation': ""Department of Ultrasound, The First Affiliated Hospital of Xi'an Jiaotong University, China.""}, {'ForeName': 'Buyue', 'Initials': 'B', 'LastName': 'Qian', 'Affiliation': ""National Engineering Lab for Big Data Analytics, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Litao', 'Initials': 'L', 'LastName': 'Ruan', 'Affiliation': ""Department of Ultrasound, The First Affiliated Hospital of Xi'an Jiaotong University, China.""}, {'ForeName': 'Changchang', 'Initials': 'C', 'LastName': 'Yin', 'Affiliation': ""National Engineering Lab for Big Data Analytics, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Ciping', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': ""National Engineering Lab for Big Data Analytics, Xi'an Jiaotong University, Xi'an, China.""}]",Journal of thoracic disease,['10.21037/jtd-19-3013']
1950,33145065,Effect of ticagrelor with or without aspirin on vein graft outcome 1 year after on-pump and off-pump coronary artery bypass grafting.,"Background
In the present post hoc analysis of the DACAB trial, we evaluated the effects of ticagrelor with or without aspirin on 1-year vein graft outcomes after coronary artery bypass grafting (CABG) with and without cardiopulmonary bypass (CPB) (on-pump and off-pump).
Methods
The DACAB trial was a multicenter, randomized, open-label, parallel control study enrolling 500 patients with 1,460 vein grafts undergoing CABG. For current post-hoc study, all patients in the DACAB study were included in the analysis to compare the effects of different antiplatelet regimens under on/off pump. Patients were randomly assigned to 1 of 3 antiplatelet treatment regimens (ticagrelor plus aspirin, T + A; ticagrelor alone, T; or aspirin alone, A) within 24 hours after CABG, and were stratified into on-pump and off-pump subgroups. The primary outcome was 1-year vein graft patency rate.
Results
Totally 121 patients underwent on-pump CABG (39 with 121 vein grafts in T + A, 36 with 101 vein grafts in T, and 46 with 137 vein grafts in A) and 379 patients underwent off-pump CABG (129 with 336 vein grafts in T + A, 130 with 387 vein grafts in T, and 120 with 348 vein grafts in A). Compared with A, T + A showed a higher 1-year vein graft patency rate in both on-pump (adjusted OR for non-patency =0.62, 95% CI: 0.16-2.45) and off-pump (adjusted OR for non-patency =0.35, 95% CI: 0.20-0.62) subgroups, P interaction =0.647; whereas T did not in either on-pump (adjusted OR for non-patency = 0.92, 95% CI: 0.31-2.76) or off-pump (adjusted OR for non-patency =0.58, 95% CI: 0.34-1.00) subgroups, P interaction =0.430.
Conclusions
In the DACAB trial, for patients underwent either on-pump or off-pump CABG, ticagrelor plus aspirin showed consistent benefit for achieving 1-year vein graft patency, with particular benefit being seen in the off-pump.",2020,"Compared with A, T + A showed a higher 1-year vein graft patency rate in both on-pump (adjusted OR for non-patency =0.62, 95% CI: 0.16-2.45) and off-pump (adjusted OR for non-patency =0.35, 95% CI: 0.20-0.62) subgroups, P interaction =0.647; whereas T did not in either on-pump (adjusted OR for non-patency = 0.92, 95% CI: 0.31-2.76) or off-pump (adjusted OR for non-patency =0.58, 95% CI: 0.34-1.00) subgroups, P interaction =0.430","['vein graft outcome 1 year after on-pump and off-pump coronary artery bypass grafting', 'Totally 121 patients underwent on', '39 with 121 vein grafts in T + A, 36 with 101 vein grafts in T, and 46 with 137 vein grafts in A) and 379 patients underwent off', '500 patients with 1,460 vein grafts undergoing CABG']","['ticagrelor with or without aspirin', 'ticagrelor plus aspirin', 'antiplatelet treatment regimens (ticagrelor plus aspirin, T + A; ticagrelor alone, T; or aspirin', 'pump CABG', 'coronary artery bypass grafting (CABG) with and without cardiopulmonary bypass (CPB']","['1-year vein graft patency', '1-year vein graft patency rate', '1-year vein graft outcomes']","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",500.0,0.14358,"Compared with A, T + A showed a higher 1-year vein graft patency rate in both on-pump (adjusted OR for non-patency =0.62, 95% CI: 0.16-2.45) and off-pump (adjusted OR for non-patency =0.35, 95% CI: 0.20-0.62) subgroups, P interaction =0.647; whereas T did not in either on-pump (adjusted OR for non-patency = 0.92, 95% CI: 0.31-2.76) or off-pump (adjusted OR for non-patency =0.58, 95% CI: 0.34-1.00) subgroups, P interaction =0.430","[{'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiovascular Surgery, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Cardiovascular Surgery, Changhai Hospital of Shanghai, Shanghai, China.'}, {'ForeName': 'Minlu', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Cancer Control and Prevention, Shanghai Municipal Center for Disease Control and Prevention, Shanghai, China.'}, {'ForeName': 'Junlong', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiovascular Surgery, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiothoracic Surgery, Xinhua Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, Nanjing First Hospital, Nanjing, China.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'Department of Cardiovascular Surgery, Changhai Hospital of Shanghai, Shanghai, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiovascular Surgery, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",Journal of thoracic disease,['10.21037/jtd-20-1177']
1951,33145067,"The effectiveness of preemptive analgesia for relieving postoperative pain after video-assisted thoracoscopic surgery (VATS): a prospective, non-randomized controlled trial.","Background
The effectiveness of preemptive analgesia (PA) for relieving postoperative pain and reducing the side effects of analgesics following video-assisted thoracoscopic surgery (VATS) has not yet been determined. This study intends to test the clinical application value of PA in the perioperative period of VATS.
Methods
From January 2018 to August 2018, we divided patients who underwent VATS in our hospital into a trial group (PA group) and a control group (traditional analgesia group, TA group). The PA group received a PA program, and the TA group was administered a conventional postoperative analgesia scheme. We compared the two groups according to the intensity of postoperative pain using the numeric rating scale (NRS), the incidence rate of analgesic drug-related adverse reactions, and the severity of stress-induced inflammation.
Results
One hundred five cases from the PA group, and 80 cases from the TA group were included in the analysis. There were no significant differences between the two groups in baseline characteristics (P>0.05). The PA group had a lower incidence rate of side effects from the analgesics compared to the TA group, and there was a statistical difference at 48 and 72 hours after surgery (P<0.05). The PA group had a slightly lower score than the TA group for postoperative resting pain. However, this difference was not statistically significant (P>0.05). The motion pain NRS score of the PA group was lower than the TA group, and although there were no significant differences at 4, 24, and 48 hours (P>0.05), there was a statistically significant difference at 72 hours (P<0.05). In the subset of patients with motion pain NRS ≥3 points, the PA group was marginally higher than the TA group at 4 hours (P>0.05) but was lower than the TA group at 24, 48, and 72 hours, with a statistically significant difference at 24 and 72 hours (P<0.05). There were no statistically significant differences in perioperative stress indexes between the two groups (P>0.05).
Conclusions
PA can relieve postoperative pain following VATS and reduce the incidence rate of analgesic drug-related adverse effects.",2020,"The PA group had a lower incidence rate of side effects from the analgesics compared to the TA group, and there was a statistical difference at 48 and 72 hours after surgery (P<0.05).","['One hundred five cases from the PA group, and 80 cases from the TA group were included in the analysis', 'From January 2018 to August 2018, we divided patients who underwent VATS in our hospital into a trial group (PA group) and a']","['video-assisted thoracoscopic surgery (VATS', 'control group (traditional analgesia group, TA', 'preemptive analgesia', 'preemptive analgesia (PA', 'TA', 'PA program']","['incidence rate of side effects', 'motion pain NRS score', 'perioperative stress indexes', 'intensity of postoperative pain using the numeric rating scale (NRS), the incidence rate of analgesic drug-related adverse reactions, and the severity of stress-induced inflammation', 'postoperative pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.0346267,"The PA group had a lower incidence rate of side effects from the analgesics compared to the TA group, and there was a statistical difference at 48 and 72 hours after surgery (P<0.05).","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Kong', 'Affiliation': 'Department of Thoracic Surgery, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Jianfei', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Department of Thoracic Surgery, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Minhua', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': 'Department of Thoracic Surgery, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, China.'}, {'ForeName': 'Haifei', 'Initials': 'H', 'LastName': 'Xiang', 'Affiliation': 'Department of Anesthesiology, Enze Hospital, Taizhou Enze Medical Center (Group), Taizhou, China.'}, {'ForeName': 'Dehua', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Thoracic Surgery, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, China.'}]",Journal of thoracic disease,['10.21037/jtd-20-2500']
1952,33145100,Gabapentin versus baclofen for treatment of refractory gastroesophageal reflux-induced chronic cough.,"Refractory gastroesophageal reflux-induced chronic cough (GERC) is a special type of gastroesophageal reflux disease (GERD) with predominant cough resistant to pragmatic standard anti-reflux therapy including antisecretory agents alone or in combination with promotility agents but with a favorable response to intensified anti-reflux treatment. The condition is not rare and is difficult to treat. Neuromodulators such as baclofen and gabapentin are considered potential therapeutic options for refractory GERC. Limited data indicate that gabapentin and baclofen could attenuate the cough symptom in patients with refractory GERC by blockade of gastroesophageal reflux or by direct antitussive effects. However, no study has compared the efficacy of these two drugs in treatment of refractory GERC. In an open-labeled randomized clinical study, we demonstrated that, as add-on therapy, gabapentin and baclofen had a similar prevalence of therapeutic success for suspected refractory GERC but gabapentin may be more preferable because of its fewer central side effects. The efficacy of baclofen and gabapentin was suboptimal, so further studies are needed to select the patients with refractory GERC suitable for precise treatment using these two neuromodulators.",2020,Refractory gastroesophageal reflux-induced chronic cough (GERC) is a special type of gastroesophageal reflux disease (GERD) with predominant cough resistant to pragmatic standard anti-reflux therapy including antisecretory agents alone or in combination with promotility agents but with a favorable response to intensified anti-reflux treatment.,"['refractory gastroesophageal reflux-induced chronic cough', 'Refractory gastroesophageal reflux-induced chronic cough (GERC']","['baclofen and gabapentin', 'gabapentin', 'Gabapentin versus baclofen', 'gabapentin and baclofen']",['cough symptom'],"[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}]",,0.0236301,Refractory gastroesophageal reflux-induced chronic cough (GERC) is a special type of gastroesophageal reflux disease (GERD) with predominant cough resistant to pragmatic standard anti-reflux therapy including antisecretory agents alone or in combination with promotility agents but with a favorable response to intensified anti-reflux treatment.,"[{'ForeName': 'Mengru', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Tongji Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Tongji Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Dong', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Tongji Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhongmin', 'Initials': 'Z', 'LastName': 'Qiu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Tongji Hospital, Tongji University School of Medicine, Shanghai, China.'}]",Journal of thoracic disease,['10.21037/jtd-2020-icc-002']
1953,33145210,"Randomized Trial to Compare Plasma Glucose Trends in Patients Undergoing Surgery for Supratentorial Gliomas under Maintenance of Sevoflurane, Desflurane, and Propofol.","Background
Anesthetic agents influence the glycemic response by affecting the neuroendocrine surgical response or directly modifying pancreatic insulin release. Due to chances of neuronal damage, intraoperative hyperglycemia and hypoglycemia both are detrimental for patients undergoing neurosurgeries. Inhalational (sevoflurane and desflurane) and intravenous (propofol) agents have been found to raise intraoperative glucose levels in nonneurological surgeries.
Aim
We aimed to compare the intraoperative glucose levels in supratentorial glioma surgeries under the maintenance of three anesthetic agents such as sevoflurane, desflurane, and propofol.
Materials and Methods
This randomized trial was conducted with 90 nondiabetic adults with supratentorial glioma. Thirty patients were allocated randomly to the three groups receiving sevoflurane, desflurane, and propofol. Baseline and hourly plasma glucose levels were recorded. Postoperatively, the time required to achieve an Aldrete score of 9 and complications were assessed.
Results
Baseline plasma glucose levels were 111.23 ± 11.67, 109.47 ± 19.75, and 111.7 ± 13.88 mg/dL ( P = 0.84) in sevoflurance, desflurane, and propofol group, respectively. All of them showed an elevation of plasma glucose in relation to the time of surgery with variable trends. In the 4 th and 5 th h, the elevations in the inhalational groups (sevoflurane and desflurane) were significantly higher than the propofol group ( P = 0.003 and 0.002, respectively). The time for achieving Aldrete's score of 9 was higher in the propofol group ( P < 0.0001). No differences were observed in the duration of hospital stay or complications.
Conclusions
Maintenance of anesthesia in nondiabetic patients showed clinically modest rise of plasma glucose which is higher in patients under sevoflurane and desflurane than under propofol. However, the immediate recovery was faster with inhalational agents compared to propofol-based anesthesia.",2020,The time for achieving Aldrete's score of 9 was higher in the propofol group ( P < 0.0001).,"['patients undergoing neurosurgeries', 'nondiabetic patients', 'supratentorial glioma surgeries', 'Patients Undergoing Surgery for Supratentorial Gliomas under Maintenance of', '90 nondiabetic adults with supratentorial glioma', 'nonneurological surgeries', 'Thirty patients']","['Inhalational (sevoflurane and desflurane', 'propofol', 'sevoflurane, desflurane, and propofol', 'Sevoflurane, Desflurane, and Propofol', 'desflurane', 'intravenous (propofol', 'sevoflurane']","['time required to achieve an Aldrete score of 9 and complications', 'plasma glucose', 'elevation of plasma glucose', 'Baseline plasma glucose levels', 'duration of hospital stay or complications', 'Baseline and hourly plasma glucose levels', ""time for achieving Aldrete's score"", 'glycemic response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1821424', 'cui_str': 'Post Anesthetic Recovery score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}]",90.0,0.0338068,The time for achieving Aldrete's score of 9 was higher in the propofol group ( P < 0.0001).,"[{'ForeName': 'Rudrashish', 'Initials': 'R', 'LastName': 'Haldar', 'Affiliation': 'Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Ashish Kumar', 'Initials': 'AK', 'LastName': 'Kannaujia', 'Affiliation': 'Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Ruchi', 'Initials': 'R', 'LastName': 'Verma', 'Affiliation': 'Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Himel', 'Initials': 'H', 'LastName': 'Mondal', 'Affiliation': 'Department of Physiology, Bhima Bhoi Medical College and Hospital, Balangir, Odisha, India.'}, {'ForeName': 'Devendra', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Shashi', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}]",Asian journal of neurosurgery,['10.4103/ajns.AJNS_235_20']
1954,33145214,Comparison of Ketofol (Combination of Ketamine and Propofol) and Propofol Anesthesia in Aneurysmal Clipping Surgery: A Prospective Randomized Control Trial.,"Background
The maintenance of hemodynamic stability is of pivotal importance in aneurysm surgeries. While administering anesthesia in these patients, the fluctuations in blood pressure may directly affect transmural pressure, thereby precipitating rupture of aneurysm and various other associated complications. We aimed to compare the effects of ketofol with propofol alone when used as an induction and maintenance anesthetic agent during surgical clipping of intracranial aneurysms.
Materials and Methods
Forty adult, good-grade aneurysmal subarachnoid hemorrhage patients posted for aneurysm neck clipping were included in the study. The patients were randomized into two groups. One group received a combination of ketamine and propofol (1:5 ratio) and the other group received propofol for induction and maintenance of anesthesia. Intraoperative hemodynamic stability, intraventricular pressure, and quality of brain relaxation were studied in both the groups.
Results
The patients were comparable with respect to demographic profile, Hunt and Hess grade, world federation of neurological surgeons (WFNS) grade, Fisher grade, duration of anesthesia, duration of surgery, optic nerve sheath diameter, and baseline hemoglobin. Intraoperative hemodynamics were better maintained in the ketofol group during induction, with only 15% of patients having >20% fall in mean arterial pressure (from baseline) intraoperatively, compared to 45% of patients receiving propofol alone ( P = 0.038). The mean intraventricular pressure values in both the groups were in the normal range and the quality of brain relaxation was similar, with no significant difference ( P > 0.05).
Conclusion
Ketofol combination (1:5) as compared to propofol alone provides better hemodynamic stability on induction as well as maintenance anesthesia without causing an increase in intracranial pressure. Effect of ketofol on cerebral oxygenation and quality of emergence need to be evaluated further by larger multicentric, randomized control trials.",2020,"Intraoperative hemodynamics were better maintained in the ketofol group during induction, with only 15% of patients having >20% fall in mean arterial pressure (from baseline) intraoperatively, compared to 45% of patients receiving propofol alone ( P = 0.038).","['Aneurysmal Clipping Surgery', 'Materials and Methods\n\n\nForty adult, good-grade aneurysmal subarachnoid hemorrhage patients posted for aneurysm neck clipping']","['Ketofol (Combination of Ketamine and Propofol', 'ketamine and propofol', 'propofol', 'Propofol Anesthesia', 'ketofol']","['cerebral oxygenation and quality', 'Intraoperative hemodynamic stability, intraventricular pressure, and quality of brain relaxation', 'Intraoperative hemodynamics', 'intracranial pressure', 'quality of brain relaxation', 'mean intraventricular pressure values', 'mean arterial pressure']","[{'cui': 'C0439651', 'cui_str': 'Aneurysmal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0206177', 'cui_str': 'Ventricular pressures'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",40.0,0.0326248,"Intraoperative hemodynamics were better maintained in the ketofol group during induction, with only 15% of patients having >20% fall in mean arterial pressure (from baseline) intraoperatively, compared to 45% of patients receiving propofol alone ( P = 0.038).","[{'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Panda', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chauhan', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Summit Dev', 'Initials': 'SD', 'LastName': 'Bloria', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bharti', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Bhagat', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Vishwanath', 'Initials': 'V', 'LastName': 'Bhaire', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Luthra', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Chhabra', 'Affiliation': 'Department of Neurosurgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Shalvi', 'Initials': 'S', 'LastName': 'Mahajan', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}]",Asian journal of neurosurgery,['10.4103/ajns.AJNS_346_19']
1955,33145215,Comparison of Propofol and Sevoflurane on Cerebral Oxygenation Using Juglar Venous Oximetery (SjVo 2 ) in Patients Undergoing Surgery for Traumatic Brain Injury.,"Background
Traumatic brain injury (TBI) induces major insult to the normal cerebral physiology. The anesthetic agents may infrequently produce deleterious effects and further aggravate damage to the injured brain. This study was conducted to evaluate the effects of propofol and sevoflurane on cerebral oxygenation, brain relaxation, systemic hemodynamic parameters and levels of interleukin-6 (IL-6) in patients with severe TBI undergoing decompressive craniectomy.
Methods
A prospective randomized comparative study was conducted on 42 patients undergoing surgery for severe TBI. Patients were randomized into two groups, Group P received propofol and Group S received sevoflurane for maintenance of anesthesia. All patients were induced with fentanyl, propofol, and vecuronium. The effect of these agents on cerebral oxygenation was assessed by jugular venous oxygen saturation (SjVO 2 ). Hemodynamic changes and quality of intraoperative brain relaxation were also assessed. The serum levels of IL-6 were quantitated using enzyme-linked immunosorbent assay technique.
Results
SjVO 2 values were comparable and mean arterial pressure (MAP) was found to be significantly lower in Group P as compared to those in Group S ( P < 0.05). Brain relaxation scores were comparable between the groups. The level of IL-6 decreased significantly at the end of surgery compared to baseline in patients receiving sevoflurane ( P = 0.040).
Conclusions
Cerebral oxygenation measured by SjVO 2 was comparable when anesthesia was maintained with propofol or sevoflurane. However, significant reduction in MAP by propofol needs attention in patients with severe TBI. The decrease in IL-6 level reflects anti-inflammatory effect and probable neuroprotective potential of propofol and sevoflurane.",2020,"The level of IL-6 decreased significantly at the end of surgery compared to baseline in patients receiving sevoflurane ( P = 0.040).
","['42 patients undergoing surgery for severe TBI', 'patients with severe TBI', 'patients with severe TBI undergoing decompressive craniectomy', 'Patients Undergoing Surgery for Traumatic Brain Injury']","['propofol or sevoflurane', 'propofol', 'Propofol and Sevoflurane', 'fentanyl, propofol, and vecuronium', 'propofol and sevoflurane', 'sevoflurane']","['Cerebral oxygenation', 'cerebral oxygenation, brain relaxation, systemic hemodynamic parameters and levels of interleukin-6 (IL-6', 'Hemodynamic changes and quality of intraoperative brain relaxation', 'mean arterial pressure (MAP', 'Brain relaxation scores', 'serum levels of IL-6', 'jugular venous oxygen saturation (SjVO 2 ', 'level of IL-6', 'Cerebral Oxygenation', 'IL-6 level', 'cerebral oxygenation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C2717817', 'cui_str': 'Decompressive craniectomy'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0242531', 'cui_str': 'Vecuronium'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428176', 'cui_str': 'Venous oxygen saturation measurement'}]",42.0,0.0225493,"The level of IL-6 decreased significantly at the end of surgery compared to baseline in patients receiving sevoflurane ( P = 0.040).
","[{'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chauhan', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Panda', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Bhagat', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bharti', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Luthra', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Shiv Lal', 'Initials': 'SL', 'LastName': 'Soni', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Narender', 'Initials': 'N', 'LastName': 'Kaloria', 'Affiliation': 'Department of Anesthesia and Intensive Care, AIIMS, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Salunke', 'Affiliation': 'Department of Neurosurgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Vishwanath', 'Initials': 'V', 'LastName': 'Bhaire', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}, {'ForeName': 'Summit Dev', 'Initials': 'SD', 'LastName': 'Bloria', 'Affiliation': 'Department of Anesthesia and Intensive Care, PGIMER, Chandigarh, India.'}]",Asian journal of neurosurgery,['10.4103/ajns.AJNS_348_19']
1956,33145289,A prospective randomized cohort study on 3D-printed artificial vertebral body in single-level anterior cervical corpectomy for cervical spondylotic myelopathy.,"Background
This was a prospective randomized cohort study aiming at examining the safety and efficacy of artificial vertebral body (AVB) fabricated by electron beam melting (EBM) in comparison to conventional titanium mesh cage (TMC) used in single-level anterior cervical corpectomy and fusion (SL-ACCF).
Methods
Forty patients with cervical spondylotic myelopathy (CSM) underwent SL-ACCF using either the EBM-AVB or the TMC. Patients were evaluated for their demographics, radiological characteristics, neurologic function [using the Japanese Orthopaedic Association (JOA) scale], and health-related quality-of-life (HRQoL) aspects [using the Short Form 36 (SF-36)] before and after the surgery and comparison was made between the two groups both at baseline and the last follow-up. The Student t-text, paired-sample t-text, and Fisher's exact test were used when appropriate to detect any statistical significance at the level of α=0.05.
Results
Post-operative recovery was uneventful for all patients and no revision surgery was required. There were no significant differences between the EBM-AVB group and the TMC group at baseline. Patients in both groups demonstrated significant improvement in cervical alignment, JOA score, and SF-36 score after the surgery. Six months post-operatively, patients in the EBM-AVB group were found to have significantly less loss of fusion height and lower incidence for severe implant subsidence compared with the TMC group. Patients in the two groups were comparable at the last follow-up regarding their rate of fusion, cervical alignment, JOA recovery rate, SF-36 score, and by Odom's criteria.
Conclusions
For CSM patients undergoing SL-ACCF, the EBM-AVB group demonstrated comparable outcomes regarding patient cervical alignment, neurologic function, and HRQoL in comparison with the TMC group. Furthermore, the use of EBM-AVB was associated with decreased loss of the height of the fusion mass and a lower rate for severe implant subsidence.",2020,"Patients in both groups demonstrated significant improvement in cervical alignment, JOA score, and SF-36 score after the surgery.","['Forty patients with cervical spondylotic myelopathy (CSM) underwent', 'CSM patients undergoing SL-ACCF']","['TMC', 'artificial vertebral body (AVB) fabricated by electron beam melting (EBM', 'SL-ACCF', '3D-printed artificial vertebral body in single-level anterior cervical corpectomy', 'EBM-AVB or the TMC', 'conventional titanium mesh cage (TMC']","['patient cervical alignment, neurologic function, and HRQoL', 'severe implant subsidence', 'cervical alignment, JOA score, and SF-36 score', 'loss of fusion height', ""rate of fusion, cervical alignment, JOA recovery rate, SF-36 score, and by Odom's criteria"", 'demographics, radiological characteristics, neurologic function [using the Japanese Orthopaedic Association (JOA) scale], and health-related quality-of-life (HRQoL) aspects [using the Short Form 36 (SF-36']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0337189', 'cui_str': 'Cage'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0013840', 'cui_str': 'Electron beam'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0050572', 'cui_str': 'ACP protocol'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3805110', 'cui_str': 'Implant subsidence'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",40.0,0.0282736,"Patients in both groups demonstrated significant improvement in cervical alignment, JOA score, and SF-36 score after the surgery.","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wei', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Nanfang', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Zihe', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Xiaoguang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Shengfa', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Fengliang', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Zhongjun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}]",Annals of translational medicine,['10.21037/atm-19-4719']
1957,33147543,The influence of age on spinal and lower limb muscle activity during repetitive lifting.,"This study investigated the effects of age on upper erector spinae (UES), lower erector spinae (LES) and lower body (gluteus maximus; biceps femoris; and vastus lateralis) muscle activity during a repetitive lifting task. Twenty-four participants were assigned to two age groups: 'younger' (n = 12; mean age ± SD = 24.6 ± 3.6 yrs) and 'older' (n = 12; mean age = 46.5 ± 3.0 yrs). Participants lifted and lowered a box (13 kg) repetitively at a frequency of 10 lifts per minute for a maximum of 20 min. EMG signals were collected every minute and normalised to a maximum voluntary isometric contraction. A submaximal endurance test of UES and LES was used to assess fatigue. Older participants showed higher levels of UES and LES muscle activity (approximately 12-13%) throughout the task, but less fatigue compared to the younger group post-task completion. When lifting, lower-limb muscle activity was generally higher in older adults, although temporal changes were similar. While increased paraspinal muscle activity may increase the risk of back injury in older workers when repetitive lifting, younger workers may be more susceptible to fatigue-related effects. Education and training in manual materials handling should consider age-related differences when developing training programmes.",2020,"Older participants showed higher levels of UES and LES muscle activity (approximately 12-13%) throughout the task, but less fatigue compared to the younger group post-task completion.","[""Twenty-four participants were assigned to two age groups: 'younger' (n\xa0=\xa012; mean age\xa0±\xa0SD\xa0=\xa024.6\xa0±\xa03.6 yrs) and 'older' (n\xa0=\xa012; mean age\xa0=\xa046.5\xa0±\xa03.0 yrs"", 'Older participants']",['UES and LES'],"['paraspinal muscle activity', 'levels of UES and LES muscle activity', 'lower-limb muscle activity', 'upper erector spinae (UES), lower erector spinae (LES) and lower body (gluteus maximus; biceps femoris; and vastus lateralis) muscle activity', 'fatigue']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0448353', 'cui_str': 'Deep muscle of back'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0224424', 'cui_str': 'Structure of gluteus maximus muscle'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",24.0,0.0286904,"Older participants showed higher levels of UES and LES muscle activity (approximately 12-13%) throughout the task, but less fatigue compared to the younger group post-task completion.","[{'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Boocock', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, New Zealand. Electronic address: mark.boocock@aut.ac.nz.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, New Zealand.'}, {'ForeName': 'Grant A', 'Initials': 'GA', 'LastName': 'Mawston', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, New Zealand.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2020.102482']
1958,33147593,Sealing Proximal Non- and Micro-Cavitated Carious Lesions Using a One-Session Separator Technique: A 2-Year Randomised Clinical Study.,"The presence of initial caries accounts for the majority of approximal carious lesions in many countries. The aim of this clustered, split-mouth, randomised, controlled clinical trial was to use a metal separator to widen the approximal space in a one-visit session before sealing and to evaluate patient acceptance, together with the efficacy of the proximal sealing in arresting incipient carious lesions after 2 years. A total of 48 patients with a mean age of 41.9 years were selected. They had at least one pair of proximal initial carious lesions, including the distal surface of the canines to the mesial surface of the third molars (bite-wing score D1-D3). The patient's caries risk at baseline was analyzed using a Cariogram. All surfaces were examined for mutans streptococci (ms) counts. The separator technique made it possible to diagnose whether or not a microcavity was present. After 2 years, 212 surfaces in 45 subjects were examined using the same as baseline standardized digital follow-up radiographs. Two analyses were performed, one sensitive, where a progression or a regression was assessed if one of the examiners made one of those diagnoses, and one conservative, where unchanged. For both analyses, the sealed test surfaces showed a significantly higher regression (67 and 29%) compared to the control group (13 and 2%) p < 0.0001. It did not appear that the baseline variables, such as the caries risk, surface diagnoses, or ms counts, influenced the caries outcome. In the test group, there was no difference in caries progression if there was a microcavity or not. The separation treatment was well accepted by the patients. The method of separation for diagnosis and sealing treatment in a single session appears to be a clinically applicable method for the control of proximal carious lesions.",2020,"For both analyses, the sealed test surfaces showed a significantly higher regression (67 and 29%) compared to the control group (13 and 2%) p < 0.0001.","['48 patients with a mean age of 41.9 years were selected', 'After 2 years, 212 surfaces in 45 subjects']","['proximal sealing', 'Sealing Proximal Non- and Micro-Cavitated Carious Lesions']",['caries progression'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",48.0,0.0241759,"For both analyses, the sealed test surfaces showed a significantly higher regression (67 and 29%) compared to the control group (13 and 2%) p < 0.0001.","[{'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Lindquist', 'Affiliation': 'Department of Cariology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden, birgitta.lindquist@odontologi.gu.se.'}, {'ForeName': 'Claes-Göran', 'Initials': 'CG', 'LastName': 'Emilson', 'Affiliation': 'Department of Cariology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Caries research,['10.1159/000509679']
1959,33147594,"Effect of Short-Term Sunlight Exposure on Blood Pressure and Pulse Rate in Vitamin D3-Insufficient, Prehypertensive Patients: A Pilot Study.","INTRODUCTION
This study was conducted to evaluate the effect of short-term sunlight exposure on blood pressure (BP) and pulse rate (PR) in vitamin D3-insufficient, prehypertensive patients.
METHODS
Twenty prehypertensive male participants were prospectively enrolled in this pilot study. BP and PR were measured using 24-hour ambulatory BP monitoring and endocrine biomarkers were assessed.
RESULTS
Sunlight exposure decreased 24-hour systolic BP (SBP), diastolic BP (DBP), and PR (SBP: 132.6 mm Hg to 129.3 mm Hg, DBP: 77.6 mm Hg to 75.7 mm Hg, and PR: 76.1 bpm to 71.3 bpm, p values: 0.0011, 0.0012, and <0.0001, respectively). The decrement patterns of SBP, DBP, and PR during nighttime (SBP: 123.5 mm Hg to 117.9 mm Hg, DBP: 72.2 mm Hg to 68.0 mm Hg, and PR: 68.2 bpm to 59.1 bpm, p values: 0.0015, 0.0003, and <0.0001, respectively) were more profound compared between daytime and nighttime. Blood levels of 25-hydroxyvitamin D3 were significantly increased (p = 0.0001) but aldosterone levels were significantly decreased (p = 0.0014) after sunlight exposure. In addition, an inverse relationship between 25-hydroxyvitamin D3 and aldosterone levels was observed (R = -0.4709, p = 0.0419).
DISCUSSION/CONCLUSION
The pilot study gives promising results that it is worthwhile to evaluate short-term sunlight exposure as a potentially effective approach in decreasing BP and PR in 25-hydroxyvitamin D3-insufficient prehypertensive patients in a larger trial with a control group.",2020,Blood levels of 25-hydroxyvitamin D3 were significantly increased (p = 0.0001) but aldosterone levels were significantly decreased (p = 0.0014) after sunlight exposure.,"['25-hydroxyvitamin D3-insufficient prehypertensive patients', 'vitamin D3-insufficient, prehypertensive patients', 'Vitamin D3-Insufficient, Prehypertensive Patients', 'Twenty prehypertensive male participants']","['short-term sunlight exposure', 'Short-Term Sunlight Exposure']","['daytime and nighttime', '25-hydroxyvitamin D3 and aldosterone levels', 'Blood Pressure and Pulse Rate', 'Blood levels of 25-hydroxyvitamin D3', '24-hour systolic BP (SBP), diastolic BP (DBP), and PR (SBP: 132.6 mm Hg to 129.3 mm Hg, DBP', 'aldosterone levels', 'BP and PR', 'SBP, DBP, and PR during nighttime', 'blood pressure (BP) and pulse rate (PR', '24-hour ambulatory BP monitoring and endocrine biomarkers']","[{'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0497062', 'cui_str': '[X]Exposure to sunlight'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1282174', 'cui_str': '24 hour systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",20.0,0.0414528,Blood levels of 25-hydroxyvitamin D3 were significantly increased (p = 0.0001) but aldosterone levels were significantly decreased (p = 0.0014) after sunlight exposure.,"[{'ForeName': 'Jin-Woo', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyoung-Ah', 'Initials': 'KA', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Min-Goo', 'Initials': 'MG', 'LastName': 'Lee', 'Affiliation': 'Department of Physiology, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea, jypark21@korea.ac.kr.'}]",Complementary medicine research,['10.1159/000510902']
1960,33147665,"Efficacy and safety of ingenol disoxate gel in field treatment of actinic keratosis on full face, scalp or large area (250 cm2) on the chest: results of four phase 3 randomized controlled trials.","INTRODUCTION
Actinic keratosis (AK) is a skin condition arising from chronic exposure to ultraviolet light and may lead to the development of malignancies. This trial aimed to evaluate efficacy and safety of ingenol disoxate gel (IngDsx, 0.018% for face/chest [FC]; 0.037% for scalp [S]), versus vehicle.
METHODS
Four identical phase 3 trials in patients with AK on the full face/up to 250cm2 of chest or full balding scalp, with an initial 8-week period and 12-month follow-up, were conducted. FC and S trials were pooled for analysis. The primary endpoint was complete clearance at Week 8.
RESULTS
Across trials, 616 patients were randomized to FC and 626 to S, with 410 and 420 assigned to receive IngDsx, respectively. In the FC and S trials, 25.9% and 24.5% of patients in the IngDsx group, respectively, achieved the primary endpoint. IngDsx was relatively well tolerated. During extended follow-up, there were more identified non-melanoma skin malignancies in the IngDsx group than vehicle group; HR: 2.38 (95% CI: 1.28, 4.41).
CONCLUSION
Treatment with IngDsx was superior to vehicle on all clinical endpoints, patient-reported and cosmetic outcomes. During the 12-month follow-up, slightly increased skin malignancies in the treatment area were identified, potentially due to unintentional detection bias.",2020,"During extended follow-up, there were more identified non-melanoma skin malignancies in the IngDsx group than vehicle group; HR: 2.38 (95% CI: 1.28, 4.41).
","['616 patients were randomized to FC and 626 to S, with 410 and 420 assigned to receive IngDsx, respectively', 'Four identical phase 3 trials in patients with AK on the full face/up to 250cm2 of chest or full balding scalp, with an initial 8-week period and 12-month follow-up, were conducted', 'actinic keratosis on full face, scalp or large area (250 cm2) on the chest']","['ingenol disoxate gel', 'ingenol disoxate gel (IngDsx']","['complete clearance', 'skin malignancies', 'Efficacy and safety', 'melanoma skin malignancies', 'tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439479', 'cui_str': 'sq. cm'}]","[{'cui': 'C0063537', 'cui_str': 'ingenol'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0151779', 'cui_str': 'Malignant melanoma of skin'}]",616.0,0.0669167,"During extended follow-up, there were more identified non-melanoma skin malignancies in the IngDsx group than vehicle group; HR: 2.38 (95% CI: 1.28, 4.41).
","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Berman', 'Affiliation': 'Center for Clinical and Cosmetic Research, Aventura, FL. bbmdphd@gmail.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bukhalo', 'Affiliation': ''}, {'ForeName': 'C William', 'Initials': 'CW', 'LastName': 'Hanke', 'Affiliation': ''}, {'ForeName': 'Mikala Fiig', 'Initials': 'MF', 'LastName': 'Jarner', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Larsson', 'Affiliation': ''}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Siegel', 'Affiliation': ''}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Skov', 'Affiliation': ''}, {'ForeName': 'Rolf-Markus', 'Initials': 'RM', 'LastName': 'Szeimies', 'Affiliation': ''}]",Dermatology online journal,[]
1961,33147894,Vitamin D Supplementation Associated to Better Survival in Hospitalized Frail Elderly COVID-19 Patients: The GERIA-COVID Quasi-Experimental Study.,"BACKGROUND
The objective of this quasi-experimental study was to determine whether bolus vitamin D supplementation taken either regularly over the preceding year or after the diagnosis of COVID-19 was effective in improving survival among hospitalized frail elderly COVID-19 patients.
METHODS
Seventy-seven patients consecutively hospitalized for COVID-19 in a geriatric unit were included. Intervention groups were participants regularly supplemented with vitamin D over the preceding year (Group 1), and those supplemented with vitamin D after COVID-19 diagnosis (Group 2). The comparator group involved participants having received no vitamin D supplements (Group 3). Outcomes were 14-day mortality and highest (worst) score on the ordinal scale for clinical improvement (OSCI) measured during COVID-19 acute phase. Potential confounders were age, gender, functional abilities, undernutrition, cancer, hypertension, cardiomyopathy, glycated hemoglobin, number of acute health issues at admission, hospital use of antibiotics, corticosteroids, and pharmacological treatments of respiratory disorders.
RESULTS
The three groups ( n = 77; mean ± SD, 88 ± 5years; 49% women) were similar at baseline (except for woman proportion, p = 0.02), as were the treatments used for COVID-19. In Group 1 ( n = 29), 93.1% of COVID-19 participants survived at day 14, compared to 81.2% survivors in Group 2 ( n = 16) ( p = 0.33) and 68.7% survivors in Group 3 ( n = 32) ( p = 0.02). While considering Group 3 as reference (hazard ratio (HR) = 1), the fully-adjusted HR for 14-day mortality was HR = 0.07 ( p = 0.017) for Group 1 and HR = 0.37 ( p = 0.28) for Group 2. Group 1 had longer survival time than Group 3 (log-rank p = 0.015), although there was no difference between Groups 2 and 3 (log-rank p = 0.32). Group 1, but not Group 2 ( p = 0.40), was associated with lower risk of OSCI score ≥5 compared to Group 3 (odds ratio = 0.08, p = 0.03).
CONCLUSIONS
Regular bolus vitamin D supplementation was associated with less severe COVID-19 and better survival in frail elderly.",2020,Group 1 had longer survival time than Group 3 (log-rank ,"['Hospitalized Frail Elderly COVID-19 Patients', 'Seventy-seven patients consecutively hospitalized for COVID-19 in a geriatric unit were included', 'hospitalized frail elderly COVID-19 patients']","['bolus vitamin D supplementation', 'no vitamin D supplements', 'Vitamin D Supplementation', 'vitamin D']","['14-day mortality and highest (worst) score on the ordinal scale for clinical improvement (OSCI', 'lower risk of OSCI score', 'longer survival time']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",77.0,0.057244,Group 1 had longer survival time than Group 3 (log-rank ,"[{'ForeName': 'Gaëlle', 'Initials': 'G', 'LastName': 'Annweiler', 'Affiliation': 'School of Medicine, Health Faculty, University of Angers, 49035 Angers, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Corvaisier', 'Affiliation': 'Department of Geriatric Medicine, Research Center on Autonomy and Longevity, University Hospital, Angers, France.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Gautier', 'Affiliation': 'Department of Geriatric Medicine, Research Center on Autonomy and Longevity, University Hospital, Angers, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Dubée', 'Affiliation': 'School of Medicine, Health Faculty, University of Angers, 49035 Angers, France.'}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Legrand', 'Affiliation': 'School of Medicine, Health Faculty, University of Angers, 49035 Angers, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Sacco', 'Affiliation': 'Department of Geriatric Medicine, Research Center on Autonomy and Longevity, University Hospital, Angers, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Annweiler', 'Affiliation': 'School of Medicine, Health Faculty, University of Angers, 49035 Angers, France.'}]",Nutrients,['10.3390/nu12113377']
1962,33147909,Randomized controlled trial of effect of N-acetylcysteine as an antioxidant on iron overload in children with thalassemia major.,"Background
β-Thalassemias are characterized by the presence of mutations in the globin gene that result in the absence or reduced synthesis of β-globin chains of the hemoglobin tetramer. Several studies have reported increased oxidative stress in β-thalassemia major (β-TM) patients. N-acetylcysteine (NAC), a derivative of L-cysteine amino acid, is commonly used as a mucolytic drug. Numerous studies have reported efficient antioxidant activity of NAC.
Purpose
To evaluate the effects of NAC on oxidative stress status and hemoglobin levels in children with β-TM.
Methods
This study was conducted between June and December 2019. One hundred β-TM patients were divided into two groups: 50 received NAC 10 mg/kg orally for 3 months (treatment group), while the other 50 received no treatment (non-treatment group). Total oxidant status (TOS), total antioxidant capacity (TAC), oxidative stress index (OSI), and hemoglobin (Hb) and ferritin levels were measured and compared between groups.
Results
At the end of the study period, Hb and TAC levels were significantly higher in the treatment group than in the non-treatment group (P < .001 and .01, respectively). On the other hand, serum ferritin levels, TOS, and OSI were significantly lower (P = .004, .01, and .001, respectively) in the treatment group.
Conclusion
NAC can effectively reduce the oxidative status and increase the pre-transfusion Hb levels in children with β-TM. Furthermore, NAC could reduce iron overload in these patients.",2020,"At the end of the study period, Hb and TAC levels were significantly higher in the treatment group than in the non-treatment group (P < .001 and .01, respectively).","['β-thalassemia major (β-TM) patients', 'One hundred β-TM patients', 'children with β-TM', 'children with thalassemia major']","['N-acetylcysteine', 'N-acetylcysteine (NAC', 'NAC']","['Total oxidant status (TOS), total antioxidant capacity (TAC), oxidative stress index (OSI), and hemoglobin (Hb) and ferritin levels', 'serum ferritin levels, TOS, and OSI', 'Hb and TAC levels', 'oxidative status', 'oxidative stress', 'oxidative stress status and hemoglobin levels']","[{'cui': 'C0002875', 'cui_str': 'Homozygous beta thalassemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]",,0.0493187,"At the end of the study period, Hb and TAC levels were significantly higher in the treatment group than in the non-treatment group (P < .001 and .01, respectively).","[{'ForeName': 'Yasmen A', 'Initials': 'YA', 'LastName': 'Mohamed', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Beni-Suef University, Egypt.'}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Meabed', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Beni-Suef University, Egypt.'}, {'ForeName': 'Amany', 'Initials': 'A', 'LastName': 'Ashraf', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Beni-Suef University, Egypt.'}, {'ForeName': 'Dalia S', 'Initials': 'DS', 'LastName': 'Morgan', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Beni-Suef University, Egypt.'}, {'ForeName': 'Mostafa G', 'Initials': 'MG', 'LastName': 'Abdul Latif', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Beni-Suef University, Egypt.'}, {'ForeName': 'Rehab M', 'Initials': 'RM', 'LastName': 'Abd-Elkareem', 'Affiliation': 'Department of Clinical and Chemical Pathology, Faculty of Medicine, Beni-Suef University, Egypt.'}, {'ForeName': 'Heba M', 'Initials': 'HM', 'LastName': 'Ahmed', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Beni-Suef University, Egypt.'}]",Clinical and experimental pediatrics,['10.3345/cep.2020.00227']
1963,33148013,Cardiovascular- and Bleeding-Related Hospitalization Rates With Edoxaban Versus Warfarin in Patients With Atrial Fibrillation Based on Results of the ENGAGE AF-TIMI 48 Trial.,"Background The ENGAGE AF-TIMI 48 trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) demonstrated noninferiority of once-daily 60 mg (30 mg dose-reduced) edoxaban compared with warfarin for prevention of stroke/systemic embolism in patients with atrial fibrillation. No previous analysis has explored the impact of treatment with edoxaban versus warfarin on rates of hospitalizations. Methods Detailed healthcare resource utilization data from ENGAGE AF-TIMI 48 for the 14 024 randomized patients who received at least one dose of study drug were used to compare the rates of bleeding- and cardiovascular-related hospitalizations for edoxaban versus warfarin. Hospitalization rates were calculated for each treatment group, and relative rates were estimated using Poisson regression. The influence of patient characteristics on the impact of edoxaban versus warfarin was evaluated through the inclusion of interaction terms. Results The overall rate of cardiovascular- or bleeding-related hospitalization was significantly lower for edoxaban than warfarin (relative rate [RR], 0.91 [95% CI, 0.85-0.97], P =0.003). Rates of hospitalizations for cardiovascular reasons (RR, 0.91 [95% CI, 0.85-0.97], P =0.004), stroke (RR, 0.80 [95% CI, 0.72-0.88], P <0.0001), and for each stroke subtype (ischemic: RR, 0.89 [95% CI, 0.81-0.99], P =0.03; hemorrhagic: RR, 0.60 [95% CI, 0.54-0.68], P <0.0001) were also lower for edoxaban. Notably, significantly greater reductions with edoxaban versus warfarin were seen for ischemic stroke-related hospitalizations in vitamin K antagonist naive patients and patients with CHADS 2 scores 4 to 6, previous stroke or transient ischemic attack, age ≥75, and no previous coronary artery disease. For nonstroke bleeding-related hospitalizations, greater reductions with edoxaban were seen in vitamin K antagonist naive patients, patients with CHADS 2 scores 4 to 6, and patients with moderate renal dysfunction. Conclusions Edoxaban 60 mg (30 mg dose-reduced) was associated with a significantly lower overall rate of cardiovascular- or bleeding-related hospitalization and significant reductions in the subcategories of cardiovascular-related, stroke-related, bleed-related, and nonstroke cardiovascular-related hospitalizations, when compared with warfarin. These results suggest the potential for cost offsets with edoxaban, with even greater reductions in higher-risk patients. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00781391.",2020,"Rates of hospitalizations for cardiovascular reasons (RR, 0.91 [95% CI, 0.85-0.97], P =0.004), stroke (RR, 0.80 [95% CI, 0.72-0.88], P <0.0001), and for each stroke subtype (ischemic: RR, 0.89 [95% CI, 0.81-0.99], P =0.03; hemorrhagic: RR, 0.60 [95% CI, 0.54-0.68], P <0.0001) were also lower for edoxaban.","['patients with atrial fibrillation', 'AF-TIMI 48 for the 14 024 randomized patients who received at least one dose of study drug', 'Patients With Atrial Fibrillation']","['Conclusions Edoxaban', 'edoxaban', 'edoxaban versus warfarin', 'warfarin', 'Edoxaban Versus Warfarin']","['Cardiovascular- and Bleeding-Related Hospitalization Rates', 'ischemic stroke-related hospitalizations', 'Hospitalization rates', 'rates of hospitalizations', 'rates of bleeding- and cardiovascular-related hospitalizations', 'stroke', 'overall rate of cardiovascular- or bleeding-related hospitalization', 'Rates of hospitalizations for cardiovascular reasons']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]",14024.0,0.325494,"Rates of hospitalizations for cardiovascular reasons (RR, 0.91 [95% CI, 0.85-0.97], P =0.004), stroke (RR, 0.80 [95% CI, 0.72-0.88], P <0.0001), and for each stroke subtype (ischemic: RR, 0.89 [95% CI, 0.81-0.99], P =0.03; hemorrhagic: RR, 0.60 [95% CI, 0.54-0.68], P <0.0001) were also lower for edoxaban.","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Vilain', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (K.V., H.L., E.A.M.).""}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (K.V., H.L., E.A.M.).""}, {'ForeName': 'Wingham J', 'Initials': 'WJ', 'LastName': 'Kwong', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ (W.J.K.).'}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, MA (E.M.A., C.T.R., E.B., R.P.G.).""}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, MA (E.M.A., C.T.R., E.B., R.P.G.).""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, MA (E.M.A., C.T.R., E.B., R.P.G.).""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City School of Medicine (D.J.C., E.A.M.).'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, MA (E.M.A., C.T.R., E.B., R.P.G.).""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Magnuson', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (K.V., H.L., E.A.M.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.120.006511']
1964,31289313,Swept-Source Optical Coherence Tomography Biometer as Screening Strategy for Macular Disease in Patients Scheduled for Cataract Surgery.,"The aim of this study was to assess the central macular imaging captured with an optical biometer based on full-eye-length Swept-Source OCT (SS-OCT) scan as a screening strategy for identifying macular diseases in patients scheduled for cataract surgery. 1,114 eyes of 749 consecutive patients underwent a biometrical examination with IOLMaster 700 SS-OCT technology (Carl Zeiss) and conventional Spectral-Domain OCT (SD-OCT) (Spectralis OCT, Heidelberg) device analysis on the same day. Seven examiners graded the scans individually in a full-masked mode. Twenty-five eyes were excluded for media opacities. Among the 1,089 included eyes, statistical analysis revealed a mean Kendall's Coefficient of 0.83 (range 0.76-0.89). A logistic regression model demonstrated a highly significant correlation (p < 0.001) between the coefficient of concordance and SD-OCT imaging. Intraobserver reproducibility was 0.89 (range 0.86-0.91). Optical biometer SS-OCT scans showed a mean sensitivity of 0.81 and a mean specificity of 0.84. The positive and negative predictive value detected was 0.78 and 0.86, respectively. In order to predict the risk of reduced visual recovery, especially in cases of retinal pathology, optical biometer with SS-OCT scan has proven to be a useful modality for detecting macular structural abnormalities in patients undergoing cataract surgery. Conventional SD-OCT remains mandatory to confirm the presumed diagnosis.",2019,Optical biometer SS-OCT scans showed a mean sensitivity of 0.81 and a mean specificity of 0.84.,"['patients undergoing cataract surgery', 'Twenty-five eyes were excluded for media opacities', '1,114 eyes of 749 consecutive patients underwent a', 'patients scheduled for cataract surgery', 'Patients Scheduled for Cataract Surgery']","['optical biometer based on full-eye-length Swept-Source OCT (SS-OCT) scan', 'biometrical examination with IOLMaster 700 SS-OCT technology (Carl Zeiss) and conventional Spectral-Domain OCT (SD-OCT', 'Swept-Source Optical Coherence Tomography Biometer']",['Intraobserver reproducibility'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0029053', 'cui_str': 'Decreased translucency'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C1627749', 'cui_str': 'Partial coherence interferometry biometer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]",[],749.0,0.0477999,Optical biometer SS-OCT scans showed a mean sensitivity of 0.81 and a mean specificity of 0.84.,"[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Tognetto', 'Affiliation': 'Eye Clinic, Department of Medical Surgical Sciences and Health, University of Trieste, Trieste, 34129, Italy.'}, {'ForeName': 'Marco R', 'Initials': 'MR', 'LastName': 'Pastore', 'Affiliation': 'Eye Clinic, Department of Medical Surgical Sciences and Health, University of Trieste, Trieste, 34129, Italy. marco.pastore@hotmail.it.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'De Giacinto', 'Affiliation': 'Eye Clinic, Department of Medical Surgical Sciences and Health, University of Trieste, Trieste, 34129, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Merli', 'Affiliation': 'Eye Clinic, Department of Medical Surgical Sciences and Health, University of Trieste, Trieste, 34129, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Franzon', 'Affiliation': 'Department of Mathematics and Computer Science, University of Trieste, Trieste, 34129, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': ""D'Aloisio"", 'Affiliation': 'Eye Clinic, Department of Medical Surgical Sciences and Health, University of Trieste, Trieste, 34129, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Belfanti', 'Affiliation': 'Eye Clinic, Department of Medical Surgical Sciences and Health, University of Trieste, Trieste, 34129, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Giglio', 'Affiliation': 'Eye Clinic, Department of Medical Surgical Sciences and Health, University of Trieste, Trieste, 34129, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Cirigliano', 'Affiliation': 'Eye Clinic, Department of Medical Surgical Sciences and Health, University of Trieste, Trieste, 34129, Italy.'}]",Scientific reports,['10.1038/s41598-019-46243-3']
1965,33145441,A randomised controlled feasibility trial of E-health application supported care vs usual care after exacerbation of COPD: the RESCUE trial.,"Exacerbations of COPD are one of the commonest causes of admission and readmission to hospital. The role of digital interventions to support self-management in improving outcomes is uncertain. We conducted an open, randomised controlled trial of a digital health platform application (app) in 41 COPD patients recruited following hospital admission with an acute exacerbation. Subjects were randomised to either receive usual care, including a written self-management plan ( n = 21), or the myCOPD app ( n = 20) for 90 days. The primary efficacy outcome was recovery rate of symptoms measured by COPD assessment test (CAT) score. Exacerbations, readmission, inhaler technique quality of life and patient activation (PAM) scores were also captured by a blinded team. The app was acceptable in this care setting and was used by 17 of the 20 patients with sustained use over the study period. The treatment effect on the CAT score was 4.49 (95% CI: -8.41, -0.58) points lower in the myCOPD arm. Patients' inhaler technique improved in the digital intervention arm (101 improving to 20 critical errors) compared to usual care (100 to 72 critical errors). Exacerbations tended to be less frequent in the digital arm compared to usual care; 34 vs 18 events. Hospital readmissions risk was numerically lower in the digital intervention arm: OR for readmission 0.383 (95% CI: 0.074, 1.987; n = 35). In this feasibility study of the digital self-management platform myCOPD, the app has proven acceptable to patients to use and use has improved exacerbation recovery rates, with strong signals of lower re-exacerbation and readmission rates over 90 days. myCOPD reduced the number of critical errors in inhaler technique compared to usual care with written self-management. This provides a strong basis for further exploration of the use of app interventions in the context of recently hospitalised patients with COPD and informs the potential design of a large multi-centre trial.",2020,Patients' inhaler technique improved in the digital intervention arm (101 improving to 20 critical errors) compared to usual care (100 to 72 critical errors).,"['20 patients with sustained use over the study period', 'after exacerbation of COPD', 'hospitalised patients with COPD', '41 COPD patients recruited following hospital admission with an acute exacerbation']","['myCOPD app', 'E-health application supported care vs usual care', 'usual care, including a written self-management plan', 'digital health platform application (app']","['Exacerbations, readmission, inhaler technique quality of life and patient activation (PAM) scores', 'Hospital readmissions risk', 'recovery rate of symptoms measured by COPD assessment test (CAT) score', 'CAT score', 'number of critical errors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",41.0,0.0692262,Patients' inhaler technique improved in the digital intervention arm (101 improving to 20 critical errors) compared to usual care (100 to 72 critical errors).,"[{'ForeName': 'Mal', 'Initials': 'M', 'LastName': 'North', 'Affiliation': 'my mhealth Limited, Bournemouth, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bourne', 'Affiliation': 'my mhealth Limited, Bournemouth, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Green', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Anoop J', 'Initials': 'AJ', 'LastName': 'Chauhan', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Brown', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Winter', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Jones', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Neville', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Blythin', 'Affiliation': 'my mhealth Limited, Bournemouth, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Watson', 'Affiliation': 'NIHR ARC Wessex, University of Southampton, Southampton, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'NIHR ARC Wessex, University of Southampton, Southampton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Culliford', 'Affiliation': 'NIHR ARC Wessex, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Elkes', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cornelius', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Tom M A', 'Initials': 'TMA', 'LastName': 'Wilkinson', 'Affiliation': 'my mhealth Limited, Bournemouth, UK.'}]",NPJ digital medicine,['10.1038/s41746-020-00347-7']
1966,33145451,"Evaluation of efficacy and safety of a novel lipogel containing diclofenac: A randomized, placebo controlled, double-blind clinical trial in patients with signs and symptoms of osteoarthritis.","Background
Effectiveness and safety of pharmaceuticals is the prime concern of every osteoarthritis (OA) treatment. Chronic administration of NSAIDs, especially in case of geriatrics, through oral route tend to compromise the patient's safety, whereas topical treatments are not found to be effective owing their poor ability to deliver drug molecules.Thus, the present study deals with a randomized, double-blind, controlled trial conducted on patients with knee osteoarthritis (OA) for comparing the performance of a novel topical gel (liposomal gel) of diclofenac with a placebo and a marketed gel.
Methods
The patients were treated and evaluated for 6 weeks as per the Western Ontario McMaster Universities (WOMAC) Index for OA. Patients were also observed for any adverse events. All the results were analyzed statistically using Kruskal-Wallis test, followed by Student's t-test at p ≤ 0.05.
Results
Patients treated with liposomal gel showed statistically significantly improvements in treatment in comparison to the other tested formulations. All the treatments were found to be well tolerated with no report of adverse event. The results unequivocally demonstrated the superiority of the diclofenac liposomal gel, in the relieving the symptoms of OA of the knee, in comparison to placebo and marketed gel.
Conclusion
From above results it was revealed that the drug in liposome have higher therapeutic potential. Thus, this can be a safe and effective option for the management of chronic OA especially for geriatric patients.",2020,"The results unequivocally demonstrated the superiority of the diclofenac liposomal gel, in the relieving the symptoms of OA of the knee, in comparison to placebo and marketed gel.
","['patients with signs and symptoms of osteoarthritis', 'patients with knee osteoarthritis (OA']","['diclofenac liposomal gel', 'novel topical gel (liposomal gel) of diclofenac with a placebo and a marketed gel', 'placebo', 'liposomal gel', 'novel lipogel containing diclofenac']","['efficacy and safety', 'Western Ontario McMaster Universities (WOMAC) Index for OA', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1160728', 'cui_str': 'Cutaneous gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0605861,"The results unequivocally demonstrated the superiority of the diclofenac liposomal gel, in the relieving the symptoms of OA of the knee, in comparison to placebo and marketed gel.
","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bhatia', 'Affiliation': 'Department of Pharmaceutical Sciences and Technology, Maharaja Ranjit Singh Punjab Technical University, Badal Road, Bathinda, Punjab, 151 001, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Goni', 'Affiliation': 'Department of Orthopaedic Surgery, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160 012, India.'}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Chopra', 'Affiliation': 'Amity Institute of Pharmacy, Amity University, Sector 125, Noida, Uttar Pradesh, 201 303, India.'}, {'ForeName': 'Bhupinder', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'University Institute of Pharmaceutical Sciences, Panjab University, Sector 14, Chandigarh, 160 014, India.'}, {'ForeName': 'Om Prakash', 'Initials': 'OP', 'LastName': 'Katare', 'Affiliation': 'University Institute of Pharmaceutical Sciences, Panjab University, Sector 14, Chandigarh, 160 014, India.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100664']
1967,33145494,A structured mixed method process evaluation of a randomized controlled trial of Individual Placement and Support (IPS).,"Background
Individual Placement and Support (IPS) is an evidence-based work rehabilitation program helping people with moderate to severe mental illness to obtain ordinary employment. Although IPS has proven superior to other work rehabilitation programs, in many studies, the majority of the participants remain unemployed. Structured process evaluations of IPS that use mixed methods are scarce, although they could identify implementation aspects that may enhance its effect. The aim of the current study is to assess reach, fidelity, and identify barriers and facilitators to implement IPS.
Methods
The process evaluation was conducted alongside a randomized controlled trial including six IPS centers, comparing IPS with treatment as usual in a population of patients in treatment for moderate to severe mental illness. Mixed methods were used in the process evaluation, including focus group interviews with service providers, individual interviews and survey data from participants, and fidelity reviews using the validated IPS Fidelity Scale.
Results
The intervention reached the intended target group. All centers reached fair to good fidelity according to the IPS Fidelity Scale within the project period (range 97-109, SD 8.1) (see Table 5). Certain fidelity items indicated implementation issues related to employer contact, community-based services, and integration with health services. Survey data showed that less than half of the participants regarded their illness as a barrier for participating in IPS and that freedom of disclosure was important. Participant interviews gave further insight into the role of the IPS specialist, emphasizing their availability and consistent job focus.
Conclusions
Indications of implementation challenges across centers during the first year suggest special attention should be given to these aspects in an early phase to ensure higher fidelity from the start and thus enhance the effectiveness of IPS. The IPS specialist played an important role for participants and was described as positive, pushing in a positive way, and encouraging. More knowledge on the characteristics of successful IPS specialists could further enhance the effectiveness of the intervention.
Trial registration
The study was registered on clinicaltrials.gov prior to the inclusion period (reg.no: NCT01964092, registered 17/07/2013).
Supplementary information
Supplementary information accompanies this paper at 10.1186/s43058-020-00083-9.",2020,"All centers reached fair to good fidelity according to the IPS Fidelity Scale within the project period (range 97-109, SD 8.1) (see Table 5).","['six IPS centers, comparing IPS with treatment as usual in a population of patients in treatment for moderate to severe mental illness']","['IPS', 'Individual Placement and Support (IPS', '\n\n\nIndividual Placement and Support (IPS']",['IPS Fidelity Scale'],"[{'cui': 'C4750554', 'cui_str': 'Individual Placement and Support'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C4750554', 'cui_str': 'Individual Placement and Support'}]","[{'cui': 'C4750554', 'cui_str': 'Individual Placement and Support'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0647471,"All centers reached fair to good fidelity according to the IPS Fidelity Scale within the project period (range 97-109, SD 8.1) (see Table 5).","[{'ForeName': 'Tonje', 'Initials': 'T', 'LastName': 'Fyhn', 'Affiliation': 'NORCE Norwegian Research Centre, Postboks 7810, 5020 Bergen, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Ludvigsen', 'Affiliation': 'Department of Pedagogy, Religion and Social Studies, Western Norway University of Applied Sciences, Inndalsveien 28, 5063 Bergen, Norway.'}, {'ForeName': 'Silje E', 'Initials': 'SE', 'LastName': 'Reme', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}, {'ForeName': 'Frederieke', 'Initials': 'F', 'LastName': 'Schaafsma', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam University Medical Centers, Amsterdam Public Health Research Institute, PO Box 7057, Amsterdam, 1007 MB The Netherlands.'}]",Implementation science communications,['10.1186/s43058-020-00083-9']
1968,33145495,A digital mental health intervention to reduce depressive symptoms among overseas Filipino workers: protocol for a pilot hybrid type 1 effectiveness-implementation randomized controlled trial.,"Background
The current pilot randomized controlled trial (RCT) protocol will comprehensively describe the implementation of a culturally adapted Filipino version of the World Health Organization Step-by-Step (SbS-F) program, unguided online psychological intervention for people with depression based on behavioral activation, among overseas Filipino workers (OFWs) in Macao (Special Administrative Region). The main objective of this pilot study is to explore the preliminary effectiveness of the SbS-F program to decrease participant-reported depressive symptoms compared to enhanced care as usual (ECAU); and the secondary objectives are to explore the preliminary effectiveness of the SbS-F to decrease participant-reported anxiety symptoms and improve wellbeing, and to evaluate the potential for SbS-F implementation in real-world settings.
Methods
This trial will follow an effectiveness-implementation hybrid type 1 trial design and utilize the Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to accelerate the translation of clinical research into more effective implementation strategies and policies. Participants will be randomized 1:1 to control and treatment groups. Control group participants will receive ECAU that consists of brief depression psychoeducation and referral to local community partners. Treatment group participants will receive a 5-session of digital intervention through a mobile phone application. The primary outcome (depression) and psychological secondary outcomes (anxiety symptoms and wellbeing) will be measured using validated instruments. To evaluate study implementation, an embedded mixed-methods design will be used to collect data from various stakeholders. Data then will be analyzed using intention to treat principle and reported following the Consolidated Standards of Reporting Trials (CONSORT) guideline.
Discussion
This study will provide important new knowledge about the preliminary effectiveness of SbS-F, a mobile application, as a digital mental health intervention and its scalability. If SbS-F shows positive results among OFWs in Macao, it has strong potential to be used by OFWs in other countries that may also experience depression and difficulty accessing mental health services.
Trial registration
Prospective registration, Chinese Clinical Trial Registry (ChiCTR2000034959) on 26/07/2020.",2020,"This study will provide important new knowledge about the preliminary effectiveness of SbS-F, a mobile application, as a digital mental health intervention and its scalability.","['overseas Filipino workers', 'people with depression based on behavioral activation, among overseas Filipino workers (OFWs) in Macao (Special Administrative Region']","['ECAU that consists of brief depression psychoeducation', 'digital mental health intervention', 'SbS-F program', '5-session of digital intervention through a mobile phone application']","['primary outcome (depression) and psychological secondary outcomes (anxiety symptoms and wellbeing', 'depressive symptoms']","[{'cui': 'C1556093', 'cui_str': 'Filipinos'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0024403', 'cui_str': 'Macao'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003380', 'cui_str': 'Antimony'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.216812,"This study will provide important new knowledge about the preliminary effectiveness of SbS-F, a mobile application, as a digital mental health intervention and its scalability.","[{'ForeName': 'Andrian', 'Initials': 'A', 'LastName': 'Liem', 'Affiliation': 'Department of Communication, University of Macau, Macao, SAR China.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Garabiles', 'Affiliation': 'Department of Psychology, Ateneo de Manila University, Manila, Philippines.'}, {'ForeName': 'Karmia A', 'Initials': 'KA', 'LastName': 'Pakingan', 'Affiliation': 'Department of Psychology, De La Salle University, Manila, Philippines.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Zhongshan Road 2, Guangzhou, China.'}, {'ForeName': 'Agnes Iok Fong', 'Initials': 'AIF', 'LastName': 'Lam', 'Affiliation': 'Department of Communication & Centre for Macau Studies, University of Macau, Macao, SAR China.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Burchert', 'Affiliation': 'Division of Clinical-Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Hall', 'Affiliation': ""New York University (Shanghai), Shanghai, People's Republic of China.""}]",Implementation science communications,['10.1186/s43058-020-00072-y']
1969,33145532,Artificial intelligence versus expert: a comparison of rapid visual inferior vena cava collapsibility assessment between POCUS experts and a deep learning algorithm.,"Objectives
We sought to create a deep learning algorithm to determine the degree of inferior vena cava (IVC) collapsibility in critically ill patients to enable novice point-of-care ultrasound (POCUS) providers.
Methods
We used publicly available long short term memory (LSTM) deep learning basic architecture that can track temporal changes and relationships in real-time video, to create an algorithm for ultrasound video analysis. The algorithm was trained on public domain IVC ultrasound videos to improve its ability to recognize changes in varied ultrasound video. A total of 220 IVC videos were used, 10% of the data was randomly used for cross correlation during training. Data were augmented through video rotation and manipulation to multiply effective training data quantity. After training, the algorithm was tested on the 50 new IVC ultrasound video obtained from public domain sources and not part of the data set used in training or cross validation. Fleiss' κ was calculated to compare level of agreement between the 3 POCUS experts and between deep learning algorithm and POCUS experts.
Results
There was very substantial agreement between the 3 POCUS experts with κ = 0.65 (95% CI = 0.49-0.81). Agreement between experts and algorithm was moderate with κ = 0.45 (95% CI = 0.33-0.56).
Conclusions
Our algorithm showed good agreement with POCUS experts in visually estimating degree of IVC collapsibility that has been shown in previously published studies to differentiate fluid responsive from fluid unresponsive septic shock patients. Such an algorithm could be adopted to run in real-time on any ultrasound machine with a video output, easing the burden on novice POCUS users by limiting their task to obtaining and maintaining a sagittal proximal IVC view and allowing the artificial intelligence make real-time determinations.",2020,"Agreement between experts and algorithm was moderate with κ = 0.45 (95% CI = 0.33-0.56).
",['critically ill patients to enable novice point-of-care ultrasound (POCUS) providers'],[],['degree of inferior vena cava (IVC) collapsibility'],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042458', 'cui_str': 'Inferior vena cava structure'}]",220.0,0.0547253,"Agreement between experts and algorithm was moderate with κ = 0.45 (95% CI = 0.33-0.56).
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Blaivas', 'Affiliation': 'Department of Emergency Medicine, St. Francis Hospital, School of Medicine University of South Carolina Columbus South Carolina USA.'}, {'ForeName': 'Srikar', 'Initials': 'S', 'LastName': 'Adhikari', 'Affiliation': 'Department of Emergency Medicine, School of Medicine University of Arizona Tucson Arizona USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Savitsky', 'Affiliation': 'Department of Emergency Medicine, UCLA David Geffen School of Medicine UCLA Ronald Reagan Medical Center Los Angeles California USA.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Blaivas', 'Affiliation': 'Department of Emergency Medicine, Harbor-UCLA Medical Center, David Geffren School of Medicine UCLA Los Angeles California USA.'}, {'ForeName': 'Yiju T', 'Initials': 'YT', 'LastName': 'Liu', 'Affiliation': 'Michigan State University-East Lansing East Lansing Michigan USA.'}]",Journal of the American College of Emergency Physicians open,['10.1002/emp2.12206']
1970,33145695,Delayed Visits for Contraception Due to Concerns Regarding Pelvic Examination Among Women with History of Intimate Partner Violence.,"BACKGROUND
Concern regarding pelvic examinations may be more common among women experiencing intimate partner violence.
OBJECTIVE
We examined women's attitudes towards pelvic examination with history of intimate partner violence (pressured to have sex, or verbal, or physical abuse).
DESIGN
Secondary analysis of data from a cluster randomized trial on contraceptive access.
PARTICIPANTS
Women aged 18-25 were recruited at 40 reproductive health centers across the USA (2011-2013).
MAIN MEASURES
Delays in clinic visits for contraception and preference to avoid pelvic examinations, by history of ever experiencing pressured sex, verbal, or physical abuse from a sexual partner, reported by frequency (never, rarely, sometimes, often). We used multivariable logistic regression with generalized estimating equations for clustered data.
KEY RESULTS
A total of 1490 women were included. Ever experiencing pressured sex was reported by 32.4% of participants, with 16.5% reporting it rarely, 12.1% reporting it sometimes, and 3.8% reporting it often. Ever experiencing verbal abuse was reported by 19.4% and physical abuse by 10.2% of participants. Overall, 13.2% of participants reported ever having delayed going to the clinic for contraception to avoid having a pelvic examination, and 38.2% reported a preference to avoid pelvic examinations. In multivariable analysis, women reporting that they experienced pressured sex often had significantly higher odds of delaying a clinic visit for birth control (aOR 3.10 95% CI 1.39-6.84) and for reporting a preference to avoid pelvic examinations (aOR 2.91 95% CI 1.57-5.40). We found no associations between delay of clinic visits or preferences to avoid a pelvic examination and verbal or physical abuse.
CONCLUSIONS
History of pressured sex from an intimate partner is common. Among women who have experienced pressured sex, concern regarding pelvic examinations is a potential barrier to contraception. Communicating that routine pelvic examinations are no longer recommended by professional societies could potentially reduce barriers and increase preventive healthcare visits.",2020,"In multivariable analysis, women reporting that they experienced pressured sex often had significantly higher odds of delaying a clinic visit for birth control (aOR 3.10 95% CI 1.39-6.84) and for reporting a preference to avoid pelvic examinations (aOR 2.91 95% CI 1.57-5.40).","['A total of 1490 women were included', ""women's attitudes towards pelvic examination with history of intimate partner violence (pressured to have sex, or verbal, or physical abuse"", 'Women with History of Intimate Partner Violence', 'women experiencing intimate partner violence', 'Women aged 18-25 were recruited at 40 reproductive health centers across the USA (2011-2013']",[],"['Delays in clinic visits for contraception and preference to avoid pelvic examinations, by history of ever experiencing pressured sex, verbal, or physical abuse from a sexual partner, reported by frequency (never, rarely, sometimes, often', 'delaying a clinic visit for birth control']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0200045', 'cui_str': 'Manual pelvic examination'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C1621955', 'cui_str': 'Physical abuse'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]",[],"[{'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0200045', 'cui_str': 'Manual pelvic examination'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C1621955', 'cui_str': 'Physical abuse'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522498', 'cui_str': 'Rare'}]",1490.0,0.0624949,"In multivariable analysis, women reporting that they experienced pressured sex often had significantly higher odds of delaying a clinic visit for birth control (aOR 3.10 95% CI 1.39-6.84) and for reporting a preference to avoid pelvic examinations (aOR 2.91 95% CI 1.57-5.40).","[{'ForeName': 'Hunter K', 'Initials': 'HK', 'LastName': 'Holt', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco, CA, USA. Hunter.Holt@ucsf.edu.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Sawaya', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'El Ayadi', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jillian T', 'Initials': 'JT', 'LastName': 'Henderson', 'Affiliation': 'Kaiser Permanente Center for Health Research, Northwest, Portland, Oregon, USA.'}, {'ForeName': 'Corinne H', 'Initials': 'CH', 'LastName': 'Rocca', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Carolyn L', 'Initials': 'CL', 'LastName': 'Westhoff', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Cynthia C', 'Initials': 'CC', 'LastName': 'Harper', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, CA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06334-8']
1971,33145834,Methylene Blue-Mediated Photodynamic Therapy may be Superior to 5% Amorolfine Nail Lacquer for Non-Dermatophyte Onychomycosis.,"BACKGROUND
Methylene blue mediated photodynamic therapy as an antimicrobial has been reported to improve onychomycosis.
OBJECTIVES
To compare the short term efficacy of methylene blue-mediated photodynamic therapy (MB-PDT) and 5% amorolfine nail lacquer (AMO) for toenail onychomycosis using higher intensity and shorter total treatment period than previously reported.
METHODS
Twenty-seven toenails with onychomycosis were randomized to receive either six biweekly sessions of MB-PDT or AMO for twelve weeks. Dermoscopic photography was used for onychomycosis severity index assessment under a dermoscopic inspection (d-OSI) at baseline, weeks 6, 10, 14 and 22 as well as microscopic and microbiological tests. Adverse events were recorded.
RESULTS
All subjects completed the study. Causative organisms found were exclustively non-dermatophytes including Fusarium spp., Asperillus spp.,and yeasts. Fifteen toenails received MB-PDT, whilst 12 received AMO. D-OSI showed greater improvement in MB-PDT than in AMO groups at weeks 6, 10, 14 as well as 22, with median changes of -2, -3, -4 (p= 0.055). and -3 respectively in the MB-PDT group. The AMO group displayed the median d-OSI change of 0 throughout the study period. Mycological cure rate at 22 weeks in MB-PDT and AMO group was 73.3% and 66.67% (p> 0.05). Clinical cure rate at 22 weeks, in MB-PDT (26.7%) was higher than AMO (16.7%), (p> 0.05). All patients only felt comfortably warm during the MB-PDT treatment. No major adverse events were found in both groups.
CONCLUSIONS
MB-PDT appeared to be more efficacious for non-dermatophyte onychomycosis than AMO particularly in a limited period and moderately severe onychomycosis.",2020,"D-OSI showed greater improvement in MB-PDT than in AMO groups at weeks 6, 10, 14 as well as 22, with median changes of -2, -3, -4 (p= 0.055).",['Twenty-seven toenails with onychomycosis'],"['Methylene Blue-Mediated Photodynamic Therapy', 'MB-PDT or AMO', 'methylene blue-mediated photodynamic therapy (MB-PDT) and 5% amorolfine nail lacquer (AMO', 'MB-PDT', 'AMO', 'Dermoscopic photography']","['median d-OSI change', 'Adverse events', 'MB-PDT', 'adverse events', 'Mycological cure rate', 'Clinical cure rate']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0222007', 'cui_str': 'Toenails'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}]","[{'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0051736', 'cui_str': 'Amorolfine'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0022902', 'cui_str': 'Lacquer'}, {'cui': 'C2959935', 'cui_str': 'Dermoscopic photography'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",27.0,0.0221814,"D-OSI showed greater improvement in MB-PDT than in AMO groups at weeks 6, 10, 14 as well as 22, with median changes of -2, -3, -4 (p= 0.055).","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bowornsathitchai', 'Affiliation': 'Photodermatology Unit, Division Of Dermatology, Department Of Medicine, King Chulalongkorn Memorial Hospital And Faculty Of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Thammahong', 'Affiliation': 'Department Of Microbiology, Faculty Of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shoosanglertwijit', 'Affiliation': 'Department Of Manufacturing Pharmacy, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kitsongsermthon', 'Affiliation': 'Department Of Pharmaceutics And Industrial Pharmacy, Faculty Of Pharmaceutical Sciences, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wititsuwannakul', 'Affiliation': 'Photodermatology Unit, Division Of Dermatology, Department Of Medicine, King Chulalongkorn Memorial Hospital And Faculty Of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Asawanonda', 'Affiliation': 'Photodermatology Unit, Division Of Dermatology, Department Of Medicine, King Chulalongkorn Memorial Hospital And Faculty Of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Boontaveeyuwat', 'Affiliation': 'Photodermatology Unit, Division Of Dermatology, Department Of Medicine, King Chulalongkorn Memorial Hospital And Faculty Of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]","Photodermatology, photoimmunology & photomedicine",['10.1111/phpp.12624']
1972,33145841,"Efficacy and safety of the noradrenaline reuptake inhibitor, TAS-303, in women with stress urinary incontinence: Results of a double-blind, randomized, placebo-controlled, early phase II trial.","OBJECTIVE
To carry out an exploratory assessment of the efficacy and safety of TAS-303, a noradrenaline reuptake inhibitor, in women with stress urinary incontinence.
METHODS
In a double-blind, placebo-controlled, early phase II study, women with stress urinary incontinence and stress urinary incontinence-predominant mixed urinary incontinence were randomized to a placebo or TAS-303 (3 or 6 mg) once daily for 8 weeks. The main efficacy end-points were mean percentage change in incontinence episode frequency per 24 h from baseline to week 8 (the primary end-point) and week 4.
RESULTS
At week 8, the mean percentage change in incontinence episode frequency per 24 h was -34.73% in the TAS-303 3 mg group, -35.41% in the TAS-303 6 mg group and -28.07% in the placebo group (differences vs placebo, not significant). In patients with stress urinary incontinence, or incontinence episode frequency less than two episodes per 24 h at baseline, TAS-303 significantly reduced incontinence episode frequency versus placebo after 4 weeks; some secondary end-points also showed a tendency to improve in the same subgroups. No serious adverse events (e.g. central nervous system or cardiovascular effects) were observed; TAS-303 was well tolerated and had a favorable safety profile.
CONCLUSION
These findings suggest that TAS-303 is effective for improving stress urinary incontinence symptoms in some subgroups of patients with stress urinary incontinence. Therefore, further research is warranted.",2020,"No serious adverse events (e.g. central nervous system or cardiovascular effects) were observed; TAS-303 was well tolerated and had a favorable safety profile.
","['women with stress urinary incontinence', 'women with stress urinary incontinence and stress urinary incontinence-predominant mixed urinary incontinence', 'patients with stress urinary incontinence']","['TAS-303', 'placebo', 'placebo or TAS-303', 'noradrenaline reuptake inhibitor, TAS-303']","['Efficacy and safety', 'stress urinary incontinence symptoms', 'serious adverse events (e.g. central nervous system or cardiovascular effects', 'incontinence episode frequency']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1319313', 'cui_str': 'Norepinephrine reuptake inhibitor-containing product'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.218585,"No serious adverse events (e.g. central nervous system or cardiovascular effects) were observed; TAS-303 was well tolerated and had a favorable safety profile.
","[{'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Department of Urology, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Department of Female Urology, Japanese Red Cross Nagoya First Hospital, Nagoya, Japan.'}, {'ForeName': 'Mineo', 'Initials': 'M', 'LastName': 'Takei', 'Affiliation': 'Department of Urology, Harasanshin Hospital, Fukuoka, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Urology, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Momokazu', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14411']
1973,33145862,Paracetamol or nonsteroidal anti-inflammatory drugs or combination of both analgesics in acute post-trauma pain: a randomized controlled trial.,"OBJECTIVES
Non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen (also called paracetamol) are the most frequent analgesics used to relieve post-trauma pain in the emergency department. However, the utility of combining both treatments is still controversial. We sought to explore the benefits of combining a NSAID with acetaminophen compared to acetaminophen alone, or NSAID alone, in the treatment of post-traumatic pain of the extremity after discharge from the emergency department (ED).
METHODS
This is a prospective, randomized controlled trial, carried out in a single ED from March 2017 to November 2018. The included patients were randomly assigned to receive paracetamol alone, or high-dose NSAID (piroxicam) alone, or a combination of paracetamol and high-dose NSAID for 7 days after ED discharge. The primary outcome was need for additional oral analgesics. Secondary outcomes included the change of the visual numeric scale (VNS) between ED discharge (VNS D0) and 7 days later (VNS D7), ED revisits for residual pain, side effects and patient satisfaction as assessed by a Likert satisfaction scale.
RESULTS
The need for additional oral analgesics were comparable between paracetamol-NSAID combination group (9.8%) and paracetamol group (11.4%) (p=0.43). ED readmission rate was also comparable between the two groups at 5.6% and 5.8% respectively (p=0.86). In contrast, need for new analgesics and ED revisit rates were both more frequent in the high-dose NSAID group. Mean VNS decrease on D7 compared to D0 was 66%, 63% and 67%, respectively in paracetamol group, NSAID and paracetamol-NSAID combination group (p=0.32). Frequency of dissatisfaction was higher in NSAID group. Side effects were more frequent in NSAID and paracetamol-NSAID combination groups.
CONCLUSION
This study found that the combination of a high-dose NSAID with paracetamol does not increase the analgesic effect compared to paracetamol alone. We also found that paracetamol alone is superior to high-dose NSAID alone for post-traumatic extremity pain.",2020,"Mean VNS decrease on D7 compared to D0 was 66%, 63% and 67%, respectively in paracetamol group,","['post-traumatic pain of the extremity after discharge from the emergency department (ED', 'acute post-trauma pain', 'single ED from March 2017 to November 2018']","['acetaminophen alone, or NSAID alone', 'paracetamol-NSAID combination', 'paracetamol alone, or high-dose NSAID (piroxicam) alone, or a combination of paracetamol and high-dose NSAID', 'Paracetamol or nonsteroidal anti-inflammatory drugs or combination of both analgesics', 'acetaminophen (also called paracetamol', 'NSAID and paracetamol-NSAID combination', 'NSAID with acetaminophen', 'paracetamol']","['Mean VNS decrease on D7', 'need for additional oral analgesics', 'Frequency of dissatisfaction', 'Side effects', 'analgesic effect', 'change of the visual numeric scale (VNS) between ED discharge (VNS D0) and 7 days later (VNS D7), ED revisits for residual pain, side effects and patient satisfaction as assessed by a Likert satisfaction scale', 'ED readmission rate', 'new analgesics and ED revisit rates']","[{'cui': 'C1611174', 'cui_str': 'Post-traumatic pain'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C3805255', 'cui_str': 'Residual pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205314', 'cui_str': 'New'}]",,0.110333,"Mean VNS decrease on D7 compared to D0 was 66%, 63% and 67%, respectively in paracetamol group,","[{'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Msolli', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Sekma', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Toumia', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.'}, {'ForeName': 'Bel Haj Ali', 'Initials': 'BHA', 'LastName': 'Khaoula', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.'}, {'ForeName': 'Hassen Mohamed', 'Initials': 'HM', 'LastName': 'Khalil', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.'}, {'ForeName': 'Mohamed Habib', 'Initials': 'MH', 'LastName': 'Grissa', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.'}, {'ForeName': 'Wahid', 'Initials': 'W', 'LastName': 'Bouida', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.'}, {'ForeName': 'Kaouthar', 'Initials': 'K', 'LastName': 'Beltaief', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Zorgati', 'Affiliation': 'Emergency Department, Sahloul University Hospital, 4011, Sousse, Tunisia.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Methamem', 'Affiliation': 'Emergency Department, Farhat Hached University Hospital, 4031, Sousse, Tunisia.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Belguith', 'Affiliation': 'Department of Preventive Medicine, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.'}, {'ForeName': 'Riadh', 'Initials': 'R', 'LastName': 'Boukef', 'Affiliation': 'Emergency Department, Sahloul University Hospital, 4011, Sousse, Tunisia.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Boubaker', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.'}, {'ForeName': 'Semir', 'Initials': 'S', 'LastName': 'Nouira', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14169']
1974,33145979,Low socioeconomic level and enterobius vermicularis: A interventional study to children and their mothers in home.,"To determine the effects of care and monitoring provided at home to children in whom Enterobius vermicularis is detected and their mothers on the presence of observing the parasite and the knowledge and practices of the children and their mothers on the issue. This study used a pre-test-post-test quasi-experimental design. In the study, 20 students and their mothers were determined as the experimental group, while 18 students and their mothers were determined as the control group. Home visits were made to the families of the children in the experimental group for 6 months. At these home visits, health education on the parasite was provided to the mothers and the children. There were highly significant differences between the experiment and control groups in terms of E. vermicularis presence, knowledge and hygiene practice scores (p < .001).",2020,"There were highly significant differences between the experiment and control groups in terms of E. vermicularis presence, knowledge and hygiene practice scores (p < .001).","['Low socioeconomic level and enterobius vermicularis', 'children and their mothers in home', '20 students and their mothers were determined as the experimental group, while 18 students and their mothers were determined as the control group']",[],"['E.\xa0vermicularis presence, knowledge and hygiene practice scores']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600211', 'cui_str': 'Enterobius vermicularis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0146377,"There were highly significant differences between the experiment and control groups in terms of E. vermicularis presence, knowledge and hygiene practice scores (p < .001).","[{'ForeName': 'Kamuran', 'Initials': 'K', 'LastName': 'Özdil', 'Affiliation': 'Department of Aged Care Program, Health Services Vocational School, Nevşehir Hacı Bektaş Veli University, Nevşehir, Turkey.'}, {'ForeName': 'Nimet', 'Initials': 'N', 'LastName': 'Karataş', 'Affiliation': 'Department of Nursing, Semra and Vefa Küçük Faculty of Health Sciences, Nevşehir Hacı Bektaş Veli University, Nevşehir, Turkey.'}, {'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Zincir', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Erciyes University, Kayseri, Turkey.'}]",Zoonoses and public health,['10.1111/zph.12774']
1975,33145984,The impact of vitamin D supplementation as an adjuvant therapy on clinical outcomes in patients with severe atopic dermatitis: A randomized controlled trial.,"Vitamin D supplementation with standard treatment yielded positive clinical outcomes in mild and moderate atopic dermatitis; however, the potential benefit of vitamin D in severe cases remains unclear. This study aimed to evaluate the impact of vitamin D supplementation on response to standard treatment in pediatrics with severe atopic dermatitis. The patients were randomized to receive either vitamin D 3 1600 IU/day or placebo, plus baseline therapy of topical 1% hydrocortisone cream twice daily for 12 weeks. The primary endpoints were the change in mean Eczema Area and Severity Index (EASI) score at the end of the study and the mean percent change in EASI score from baseline to week 12. Eighty-six subjects completed the study. The treated group achieved a significant higher level of 25 hydroxy vitamin D (P < .001) compared to control group at week 12. The mean EASI score was significantly lower in the treatment group compared to placebo group (P = .035). The percent change in EASI score from baseline differed significantly between the supplementation (56.44 ± 29.33) and placebo (42.09 ± 19.22) groups after intervention (P = .039). Vitamin D supplementation could be an effective adjuvant treatment that improves the clinical outcomes in severe atopic dermatitis.",2020,The mean EASI score was significantly lower in the treatment group compared to placebo group (P = .035).,"['pediatrics with severe atopic dermatitis', 'patients with severe atopic dermatitis', 'Eighty-six subjects completed the study', 'mild and moderate atopic dermatitis', 'severe atopic dermatitis']","['vitamin D supplementation', 'vitamin D', 'vitamin D 3 1600\xa0IU/day or placebo, plus baseline therapy of topical 1% hydrocortisone cream', 'placebo', 'Vitamin D supplementation']","['level of 25 hydroxy vitamin D', 'EASI score', 'mean EASI score', 'change in mean Eczema Area and Severity Index (EASI) score']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C1251945', 'cui_str': 'Hydrocortisone Topical Cream'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.499308,The mean EASI score was significantly lower in the treatment group compared to placebo group (P = .035).,"[{'ForeName': 'Noha O', 'Initials': 'NO', 'LastName': 'Mansour', 'Affiliation': 'Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Amal Ahmed', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Biochemistry Department, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'Department of Dermatology and Andrology, National Research Centre, Cairo, Egypt.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Eldemiry', 'Affiliation': 'Faculty of Pharmacy, Fellow of Clinical Pharmacology, Cairo University Hospitals, Giza, Egypt.'}, {'ForeName': 'Aliaa', 'Initials': 'A', 'LastName': 'Daifalla', 'Affiliation': 'Department of Dermatology, Venerology, and Andrology, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Soha', 'Initials': 'S', 'LastName': 'Hassanin', 'Affiliation': 'Biochemistry Department, Faculty of Pharmacy, Modern University for Technology and Information, Cairo, Egypt.'}, {'ForeName': 'Nourelhuda', 'Initials': 'N', 'LastName': 'Nassar', 'Affiliation': 'Clinical Pathology Department, Elsahel Teaching Hospital, Cairo, Egypt.'}, {'ForeName': 'Doaa', 'Initials': 'D', 'LastName': 'Ghaith', 'Affiliation': 'Clinical and Chemical Pathology Department, Faculty of Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Mohamed Salah', 'Affiliation': 'Department of Dermatology, Andrology, Sexual Medicine and STDs, Faculty of Medicine, Helwan University, Cairo, Egypt.'}]",Pharmacology research & perspectives,['10.1002/prp2.679']
1976,33145992,Comparison of 3D vs 2D laparoscopic-assisted anorectal pull-through (LAARP) for high anorectal malformations in children.,"INTRODUCTION
The limitation of two-dimensional (2D) laparoscopic techniques includes lack of stereoscopic vision and depth perception which can affect surgical performance, physical and mental comfort of the operating surgeon. 3D laparoscopic surgery is popular in adults; however, its application and experience in the pediatric age group have been limited. We did a comparison of 2D and 3D laparoscopic-assisted anorectal pull-through (LAARP) in male high anorectal malformations (ARM).
MATERIAL AND METHOD
This prospective cohort study included male children diagnosed with high anorectal malformation (recto-prostatic urethral fistula) who underwent LAARP in infancy after a neonatal colostomy between November 2019 to March 2020. The patients were randomized into a 2D group or 3D group at a 1:1 ratio. Patient demographics and operative/postoperative parameters were recorded. The effect of 3D laparoscopy was assessed in terms of laparoscopy visual parameters (image quality, depth perception, hand-eye coordination, and precision), physical discomfort (5-point Likert scale), and mental strain (State-Trait Anxiety Inventory scale). The statistical tests were performed on SPSS version 16.
RESULTS
The demographics of both groups, 20 (patients in each), were similar. There was a significant reduction of laparoscopy execution time, physical discomfort (for eye, hand and wrist strain), and overall mental strain in the 3D group. There were similar complications, blood loss, and hospital stay, and no open conversion in two groups.
CONCLUSION
3D LAARP is feasible and safe in the surgical treatment of ARM in children. Further studies with assessment by more than one observer are needed to investigate the wider application of 3D in pediatric surgery.",2020,"There was a significant reduction of laparoscopy execution time, physical discomfort (for eye, hand and wrist strain), and overall mental strain in the 3D group.","['high anorectal malformations in children', 'adults', 'male high anorectal malformations (ARM', 'male children diagnosed with high anorectal malformation (recto-prostatic urethral fistula) who underwent LAARP in infancy after a neonatal colostomy between November 2019 to March 2020', 'children']","['3D laparoscopic surgery', '3D LAARP', '3D laparoscopy', '3D vs 2D laparoscopic-assisted anorectal pull-through (LAARP', '2D and 3D laparoscopic-assisted anorectal pull-through (LAARP']","['laparoscopy execution time, physical discomfort (for eye, hand and wrist strain), and overall mental strain', 'laparoscopy visual parameters (image quality, depth perception, hand-eye coordination, and precision), physical discomfort (5-point Likert scale), and mental strain (State-Trait Anxiety Inventory scale', 'complications, blood loss, and hospital stay, and no open conversion']","[{'cui': 'C0345210', 'cui_str': 'High anorectal malformation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3495676', 'cui_str': 'Anorectal anomaly'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0041970', 'cui_str': 'Urethral fistula'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009410', 'cui_str': 'Colostomy'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0011586', 'cui_str': 'Stereoscopic vision'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",,0.0380648,"There was a significant reduction of laparoscopy execution time, physical discomfort (for eye, hand and wrist strain), and overall mental strain in the 3D group.","[{'ForeName': 'Vikesh', 'Initials': 'V', 'LastName': 'Agrawal', 'Affiliation': 'Pediatric Surgery Division; Department of Surgery, Netaji Subhash Chandra Bose Government Medical College, Jabalpur, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Tiwari', 'Affiliation': 'Pediatric Surgery Division; Department of Surgery, Netaji Subhash Chandra Bose Government Medical College, Jabalpur, India.'}, {'ForeName': 'Dhananjaya', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Department of Surgery, Netaji Subhash Chandra Bose Medical College, Jabalpur, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Mishra', 'Affiliation': 'Pediatric Surgery Division; Department of Surgery, Netaji Subhash Chandra Bose Government Medical College, Jabalpur, India.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Acharya', 'Affiliation': 'Department of Surgery, Netaji Subhash Chandra Bose Medical College, Jabalpur, India.'}]",Asian journal of endoscopic surgery,['10.1111/ases.12885']
1977,33146085,[Effectiveness of a Manual Dexterity Training in German Kindergarten].,"Effectiveness of a Manual Dexterity Training in German Kindergarten The present study examines effects of a manual dexterity training with cup stacking/speed stacking exercises for children in the last year of German kindergarten. Between pre- and posttest, nine trainings sessions were conducted within two weeks. The training group consisted of N = 20 children, the waiting control group of N = 17 children. Pre- and posttest consisted of the manual dexterity scale of the Movement ABC-2 (Petermann, 2011). Compared to the control group, the training group showed significantly lower pretest scores but higher posttest scores. Results were discussed in the light of need for replications. The importance of early prevention and intervention of motor coordination problems is highlighted.",2020,"Compared to the control group, the training group showed significantly lower pretest scores but higher posttest scores.","['20 children, the waiting control group of N = 17 children', 'German Kindergarten', 'children in the last year of German kindergarten']","['manual dexterity training with cup stacking/speed stacking exercises', 'Manual Dexterity Training']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],20.0,0.0112838,"Compared to the control group, the training group showed significantly lower pretest scores but higher posttest scores.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Michel', 'Affiliation': 'Universität Würzburg Deutschland Universität Würzburg.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Kargruber', 'Affiliation': 'Universität Würzburg Deutschland Universität Würzburg.'}]",Praxis der Kinderpsychologie und Kinderpsychiatrie,['10.13109/prkk.2020.69.7.614']
1978,33146457,"No effects of dapagliflozin, metformin or exercise on plasma glucagon concentrations in individuals with prediabetes: A post-hoc analysis from the randomized controlled PRE-D trial.","AIMS
Little is known on the effects of glucose-lowering interventions in prediabetes, we therefore assessed the effects of dapagliflozin, metformin and exercise treatment on changes in plasma glucagon concentrations in individuals with overweight and HbA 1c -defined prediabetes.
MATERIALS AND METHODS
120 individuals with overweight (BMI ≥25 kg/m 2 ) and prediabetes (HbA 1c of 39-47 mmol/mol) were randomized to a 13-week intervention with dapagliflozin (10 mg once daily), metformin (850 mg twice daily), exercise (interval training 30 min, 5 days/week) or control (habitual living). A 75 g oral glucose tolerance test (OGTT) (0, 30, 60 and 120 min) was administered at baseline, at 13 weeks (end of intervention) and at 26 weeks (end of follow-up). Linear mixed-effects models with participant-specific random intercepts were used to investigate associations of the interventions with fasting plasma glucagon concentration, insulin/glucagon ratio and glucagon suppression during the OGTT.
RESULTS
At baseline, the median (Q1;Q3) age was 62 (54;68) years, median fasting plasma glucagon concentration was 11 (7;15) pmol/L, mean (SD) HbA 1c was 40.9 (2.3) mmol/mol, and 56% were women. Compared with the control group fasting glucagon did not change in any of the groups from baseline to end of intervention (dapagliflozin group: -5% (95%CI:-29;26); exercise group: -8% (95%CI:-31;24); metformin group: -2% (95%CI:-27;30)). Likewise, there were no differences in insulin/glucagon ratio and glucagon suppression during the OGTT between the groups.
CONCLUSIONS
In individuals with prediabetes 13-weeks of treatment with dapagliflozin, metformin or exercise was not associated with changes in fasting or post-OGTT glucagon concentrations. This article is protected by copyright. All rights reserved.",2020,Compared with the control group fasting glucagon did not change in any of the groups from baseline to end of intervention (dapagliflozin group: -5% (95%CI:-29;26); exercise group: -8% (95%CI:-31;24); metformin group: -2% (95%CI:-27;30)).,"['individuals with prediabetes', '120 individuals with overweight', 'individuals with overweight and HbA 1c -defined prediabetes']","['metformin', 'dapagliflozin, metformin and exercise treatment', 'exercise (interval training 30 min, 5\u2009days/week) or control (habitual living', 'dapagliflozin, metformin or exercise', 'dapagliflozin']","['fasting plasma glucagon concentration, insulin/glucagon ratio and glucagon suppression', 'insulin/glucagon ratio and glucagon suppression', 'changes in fasting or post-OGTT glucagon concentrations', 'fasting glucagon', 'plasma glucagon concentrations', 'median fasting plasma glucagon concentration']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",120.0,0.0508403,Compared with the control group fasting glucagon did not change in any of the groups from baseline to end of intervention (dapagliflozin group: -5% (95%CI:-29;26); exercise group: -8% (95%CI:-31;24); metformin group: -2% (95%CI:-27;30)).,"[{'ForeName': 'Kim K B', 'Initials': 'KKB', 'LastName': 'Clemmensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Blond', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Amadid', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Bruhn', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Vistisen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ried-Larsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'NNF Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen.'}, {'ForeName': 'Signe S', 'Initials': 'SS', 'LastName': 'Torekov', 'Affiliation': 'NNF Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jonas S', 'Initials': 'JS', 'LastName': 'Quist', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Marit E', 'Initials': 'ME', 'LastName': 'Jørgensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Faerch', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14246']
1979,33146495,Effect of an injury prevention program on the lower limb stability in young volleyball players.,"BACKGROUND
Volleyball players have a high risk of injury in the lower limbs as a consequence of the specific characteristics of the sport, such as repetitive jumps and falls. The objective of the present study was to evaluate the effects of a multidisciplinary injury prevention program on lower limb stability in young volleyball players.
METHODS
The experimental design was a non-randomized controlled trial. All the measurements were performed in a standardized room in a sports center. Twenty-six young male volleyball players (mean age: 15.39±1.16 years-old), divided into experimental (n=15) and control groups (n=11) participated in this study. The experimental group performed an 8-week prevention program including lower limb strength and plyometric training, and joint and core stability. The Y-Balance and force platform landing tests were carried out as the pre- and post-tests.
RESULTS
The main outcome measures were the injuries history, distance and difference reached in anterior, post-lateral and post-medial axis of the Y-Balance test, and the force produced in Z, X and Y axis after landing. Differences were found between groups and measurements in all the variables of the Y-Balance test, except in the frontal axis for the dominant leg and for the differences between legs (p=0.039-0.001); and in the ground reaction forces (Z axis) (p=0.040), the X axis (p=0.014) and the dynamic postural stability index (p=0.025) of the lateral jump with the non-dominant leg.
CONCLUSIONS
An 8-week prevention program seems to improve the lower limb stability in young volleyball players.",2020,"Differences were found between groups and measurements in all the variables of the Y-Balance test, except in the frontal axis for the dominant leg and for the differences between legs (p=0.039-0.001); and in the ground reaction forces (Z axis) (p=0.040), the X axis (p=0.014) and the dynamic postural stability index (p=0.025) of the lateral jump with the non-dominant leg.
","['Twenty-six young male volleyball players (mean age: 15.39±1.16 years-old), divided into experimental (n=15) and control groups (n=11) participated in this study', 'young volleyball players', 'Volleyball players']","['8-week prevention program including lower limb strength and plyometric training, and joint and core stability', 'injury prevention program', 'multidisciplinary injury prevention program']","['limb stability', 'injuries history, distance and difference reached in anterior, post-lateral and post-medial axis of the Y-Balance test, and the force produced in Z, X and Y axis after landing', 'lower limb stability', 'dynamic postural stability index', 'ground reaction forces (Z axis']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}]","[{'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",26.0,0.0290906,"Differences were found between groups and measurements in all the variables of the Y-Balance test, except in the frontal axis for the dominant leg and for the differences between legs (p=0.039-0.001); and in the ground reaction forces (Z axis) (p=0.040), the X axis (p=0.014) and the dynamic postural stability index (p=0.025) of the lateral jump with the non-dominant leg.
","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Albaladejo-Saura', 'Affiliation': 'Traumatology Chair, San Antonio Catholic University, Murcia, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Vaquero-Cristóbal', 'Affiliation': 'Traumatology Chair, San Antonio Catholic University, Murcia, Spain - rvaquero@ucam.edu.'}, {'ForeName': 'Pablo J', 'Initials': 'PJ', 'LastName': 'Marcos-Pardo', 'Affiliation': 'Faculty of Sport Sciences, San Antonio Catholic University, Murcia, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Esparza-Ros', 'Affiliation': 'Traumatology Chair, San Antonio Catholic University, Murcia, Spain.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.11477-4']
1980,33146497,Effects of whole-body vibration training with the same amplitude and different frequencies on the proximal femoral bone density in elderly women.,"BACKGROUND
This study investigated the Whole-body vibration training with the same amplitude and different vibration frequencies was used to compare the difference in bone mineral density (BMD) of the proximal femurs in elderly women.
METHODS
This study included three age-, height-, and weight-matched groups; the medium-frequency group (n=19) received 24 weeks of whole-body vibration training with a vibration frequency of 20 Hz; the high-frequency group (n=18) received 24 weeks of whole-body vibration training with a vibration frequency of 40 Hz; and the control group (n=19) received no intervention. Changes in the BMD of the proximal femur on the dominant side in the three groups were measured using dual-energy X-ray absorptiometry.
RESULTS
According to the between-group comparison, the BMD of the greater trochanter and Ward's triangle in the middle-frequency group increased by 7.6% and 13.3%, respectively (P<0.05), while the BMD of the greater trochanter and Ward's triangle in the high-frequency group increased by 10.6% and 16.9%, respectively (P<0.05). There was no significant difference in BMD between the medium-frequency group and the high-frequency group at 24 weeks (P>0.05).
CONCLUSIONS
Whole-body vibration training with a frequency of 20 Hz and 40 Hz improved the BMD of the proximal femurs in elderly women to varying degrees, but had no significant effect on femoral neck BMD. Under the same amplitude conditions, an increase in vibration frequency did not cause further changes in BMD.",2020,"There was no significant difference in BMD between the medium-frequency group and the high-frequency group at 24 weeks (P>0.05).
","['three age-, height-, and weight-matched groups; the medium-frequency group (n=19) received', 'elderly women']","['24 weeks of whole-body vibration training with a vibration frequency of 20 Hz; the high-frequency group (n=18) received 24 weeks of whole-body vibration training with a vibration frequency of 40 Hz; and the control group (n=19) received no intervention', 'whole-body vibration training']","[""BMD of the greater trochanter and Ward's triangle"", 'bone mineral density (BMD', 'femoral neck BMD', 'vibration frequency', 'BMD']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0223865', 'cui_str': 'Structure of greater trochanter of femur'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.0148758,"There was no significant difference in BMD between the medium-frequency group and the high-frequency group at 24 weeks (P>0.05).
","[{'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Chengdu Sport University, Chengdu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': 'Sichuan Sports College, Chengdu, China.'}, {'ForeName': 'Shuwan', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'Sichuan Sports College, Chengdu, China.'}, {'ForeName': 'Benxiang', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Chengdu Sport University, Chengdu, China - 516994341@qq.com.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.11514-7']
1981,33146502,Pulmonary function and quality of life after aortic valve replacement through ministernotomy: a prospective randomized study.,,2020,,[],['aortic valve replacement through ministernotomy'],['Pulmonary function and quality of life'],[],"[{'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0244319,,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gofus', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Vobornik', 'Affiliation': ''}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Koblizek', 'Affiliation': ''}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Smolak', 'Affiliation': ''}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Myjavec', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vojacek', 'Affiliation': ''}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Pojar', 'Affiliation': ''}]",Kardiologia polska,['10.33963/KP.15668']
1982,33146602,Outcome of Surgical and Conservative Treatment of Patients with Shoulder Impingement Syndrome - a Prospective Comparative Clinical Study.,"PURPOSE OF THE STUDY Subacromial impingement is one of the most common reasons for shoulder pain. The surgical management of this condition has recently become the focus of criticism because of the rising number of surgical procedures and the lack of superiority of surgical over conservative treatment. In this prospective comparative study, we compared standardised conservative care with surgical treatment and placed special emphasis on the patients' ability to work. MATERIAL AND METHODS A total of 106 patients (25 women, 81 men; mean age: 45.4 12.3 years) were included in this prospective comparative clinical study. Patients in the non-operative arm (n = 42) received standardised physiotherapy. Patients in the surgical arm (n = 38) underwent arthroscopic subacromial decompression. All patients were followed up at 3, 6 and 12 months. Shoulder function (Constant score), pain (Numerical Rating Scale), and the duration of inability to work were assessed. RESULTS Shoulder function and pain improved significantly with both kinds of treatment. At no time of follow up we detected significant differences between the two treatment options. An analysis of the patients' ability to work showed that conservative treatment was superior to surgical treatment at 3-month follow-up (0.3 versus 5.0 weeks; p < 0.001) and between 4 and 6-month after intervention (0.2 versus 1.6 weeks; p = 0.032). DISCUSSION In the study presented here, significant improvements in function (Constant score) and pain (NRS) were achieved in both the non-operative and the surgical arm. There were no significant differences between the two groups at any time point. These results are similar to those reported by other authors in recent studies. Unlike other research work, however, our study demonstrated a major difference in the development and duration of inability to work. CONCLUSIONS Conservative and surgical treatment of subacromial impingement syndrome led to similar outcomes for shoulder pain and function at 3, 6 and 12 months after intervention. However, patients who were managed conservatively returned to work significantly earlier than patients who underwent surgery. Key words: subacromial impingement, shoulder, constant score, pain, ability to work.",2020,"CONCLUSIONS Conservative and surgical treatment of subacromial impingement syndrome led to similar outcomes for shoulder pain and function at 3, 6 and 12 months after intervention.","['Patients with Shoulder Impingement Syndrome ', '106 patients (25 women, 81 men; mean age: 45.4 12.3 years']","['Surgical and Conservative Treatment', 'arthroscopic subacromial decompression', 'standardised conservative care with surgical treatment and placed special emphasis', 'standardised physiotherapy']","['Shoulder function (Constant score), pain (Numerical Rating Scale), and the duration of inability to work', 'function (Constant score) and pain (NRS', 'Shoulder function and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0408159', 'cui_str': 'Anterior decompression of shoulder joint'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4049481', 'cui_str': 'Inability to work'}]",106.0,0.0272937,"CONCLUSIONS Conservative and surgical treatment of subacromial impingement syndrome led to similar outcomes for shoulder pain and function at 3, 6 and 12 months after intervention.","[{'ForeName': 'H-C', 'Initials': 'HC', 'LastName': 'KÖhler', 'Affiliation': 'Department of Orthopaedics, Rostock University Medical Centre, Rostock, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tischer', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hacke', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gutcke', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schulze', 'Affiliation': ''}]",Acta chirurgiae orthopaedicae et traumatologiae Cechoslovaca,[]
1983,33148427,Treating diabetic all-comers with contemporary drug-eluting stents: Prespecified comparisons from the BIO-RESORT and the BIONYX randomized trials.,"BACKGROUND
Patients with diabetes have more extensive coronary disease, resulting in higher risks of adverse clinical events following stenting. In all-comer patients, contemporary DES have shown excellent safety and efficacy, but data on diabetic patients are scarce. Separately for the BIO-RESORT and BIONYX trials, we assessed the 2-year clinical outcomes of diabetic patients, treated with various contemporary drug-eluting stents (DES).
METHODS
We performed two prespecified secondary analyses of two randomized DES trials, which both stratified for diabetes. The main endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. Follow-up was finished before the COVID-19 pandemic.
RESULTS
In BIO-RESORT, 624/3514 (17.8%) had diabetes: 211 received Orsiro sirolimus-eluting stents (SES), 203 Synergy everolimus-eluting stents (EES), and 210 Resolute Integrity zotarolimus-eluting stents (RI-ZES). TVF did not differ between SES (10.2%) and EES (10.0%) versus RI-ZES (12.7%) (SES vs. RI-ZES HR:0.78, 95%-CI [0.44-1.40]; p = 0.40, EES vs. RI-ZES HR:0.79, 95%-CI [0.44-1.40]; p = 0.42). In BIONYX, 510/2488 (20.5%) patients had diabetes: 250 received SES and 260 Resolute Onyx zotarolimus-eluting stents (RO-ZES). There was no difference in TVF between SES (10.7%) versus RO-ZES (12.2%) (HR:0.88, 95%-CI [0.52-1.48]; p = 0.63).
CONCLUSIONS
There was no difference in 2-year clinical outcome among patients with diabetes, who were treated with SES, or EES, versus RI-ZES. In addition there was no difference in clinical outcome in diabetic patients, who were treated with SES versus RO-ZES. These findings may be considered as a signal of safety and efficacy of the studied DES in patients with diabetes.",2020,"There was no difference in 2-year clinical outcome among patients with diabetes, who were treated with SES, or EES, versus RI-ZES.","['Patients with diabetes', 'diabetic patients', 'diabetic patients, treated with various contemporary drug-eluting stents (DES', 'patients with diabetes']","['Orsiro sirolimus-eluting stents (SES), 203 Synergy everolimus-eluting stents (EES']","['TVF', 'target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization', 'safety and efficacy', 'TVF between SES', '2-year clinical outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.214693,"There was no difference in 2-year clinical outcome among patients with diabetes, who were treated with SES, or EES, versus RI-ZES.","[{'ForeName': 'Eline H', 'Initials': 'EH', 'LastName': 'Ploumen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Rosaly A', 'Initials': 'RA', 'LastName': 'Buiten', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Marlies M', 'Initials': 'MM', 'LastName': 'Kok', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Carine J M', 'Initials': 'CJM', 'LastName': 'Doggen', 'Affiliation': 'Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Roguin', 'Affiliation': 'Department of Cardiology, Hillel Yaffe Medical Center, Hadera and B. Rappaport-Faculty of Medicine, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Gillian A J', 'Initials': 'GAJ', 'LastName': 'Jessurun', 'Affiliation': 'Department of Cardiology, Treant Zorggroep, Scheper Hospital, Emmen, the Netherlands.'}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': 'Department of Cardiology, Haga Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Danse', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Benit', 'Affiliation': 'Department of Cardiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.'}, {'ForeName': 'K Gert', 'Initials': 'KG', 'LastName': 'van Houwelingen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Stoel', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Scholte', 'Affiliation': 'Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hartmann', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Gerard C M', 'Initials': 'GCM', 'LastName': 'Linssen', 'Affiliation': 'Department of Cardiology, Hospital Group Twente, Almelo, and Hengelo, the Netherlands.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zocca', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands. Electronic address: c.vonbirgelen@mst.nl.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.10.051']
1984,33148476,Clinical outcome results of total ankle replacement and ankle arthrodesis: a pilot randomised controlled trial.,"BACKGROUND
Ankle arthrodesis (AA) and replacement (TAA) are widely accepted options in managing end-stage ankle arthritis (ESAA). We hypothesize that clinical outcomes would be similar for both interventions.
METHODS
We conducted a multicenter randomized controlled trial that collected data on patient demographics, complication rates, Ankle Osteoarthritis Scale (AOS) and Short Form-36 (SF-36) scores. We evaluated pre and postoperative scores within and between cohorts.
RESULTS
The thirty-nine ankles enrolled had a mean follow-up of 5.1 ± 2.8 years. Total AOS scores improved significantly in both groups; 59.4 ± 15.9 to 38 ± 20 (p-value = 0.002) for TAA and 64.6 ± 19.7 to 31.8 ± 16.5 (p-value < 0.001) for AA at last follow-up. Complication rate was higher in the AA cohort with four major complications (20%).
CONCLUSION
We observed a statistically significant benefit with TAA and AA. As a pilot trial, this study is meant to inform on design and feasibility of future RCTs.
LEVEL OF EVIDENCE
II.",2020,Total AOS scores improved significantly in both groups; 59.4 ± 15.9 to 38 ± 20 (p-value = 0.002) for TAA and 64.6 ± 19.7 to 31.8 ± 16.5 (p-value < 0.001) for AA at last follow-up.,['thirty-nine ankles enrolled had a mean follow-up of 5.1 ± 2.8 years'],"['total ankle replacement and ankle arthrodesis', 'Ankle arthrodesis (AA) and replacement (TAA']","['Complication rate', 'patient demographics, complication rates, Ankle Osteoarthritis Scale (AOS) and Short Form-36 (SF-36) scores', 'Total AOS scores']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0188664', 'cui_str': 'Prosthetic total arthroplasty of ankle'}, {'cui': 'C0188661', 'cui_str': 'Arthrodesis of ankle'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0003486', 'cui_str': 'Aortic aneurysm'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0409931', 'cui_str': 'Osteoarthritis of ankle'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",39.0,0.286325,Total AOS scores improved significantly in both groups; 59.4 ± 15.9 to 38 ± 20 (p-value = 0.002) for TAA and 64.6 ± 19.7 to 31.8 ± 16.5 (p-value < 0.001) for AA at last follow-up.,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Glazebrook', 'Affiliation': 'Department of Orthopedic Surgery, Queen Elizabeth II Health Sciences Center, 1796 Summer Street, Halifax, Nova Scotia, B3H 3A7, Canada.'}, {'ForeName': 'Bernard N', 'Initials': 'BN', 'LastName': 'Burgesson', 'Affiliation': 'Dalhousie University, Division of Orthopedic Surgery, Queen Elizabeth II Health Sciences Center, 1796 Summer Street, Halifax, Nova Scotia, B3H 3A7, Canada. Electronic address: bernard.burgesson@dal.ca.'}, {'ForeName': 'Alastair S', 'Initials': 'AS', 'LastName': 'Younger', 'Affiliation': 'University of British Columbia Faculty of Medicine, Orthopaedics 1144 Burrard Street 560, Vancouver, BC, V6Z 2C7, Canada.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Daniels', 'Affiliation': 'University of Toronto, Surgery, 55 Queen Street East 800, Toronto, ON, M5N 1R6, Canada.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2020.10.005']
1985,33148479,nextMONARCH: Abemaciclib Monotherapy or Combined With Tamoxifen for Metastatic Breast Cancer.,"BACKGROUND
Abemaciclib is a selective cyclin-dependent kinase 4 and 6 inhibitor administered continuously for hormone receptor-positive (HR + ), human epidermal growth factor receptor 2-negative (HER2 - ) advanced breast cancer. Abemaciclib is associated with dose-dependent early-onset diarrhea. nextMONARCH evaluated abemaciclib monotherapy (with or without prophylactic loperamide) and combined with tamoxifen for endocrine refractory metastatic breast cancer (MBC) after chemotherapy.
PATIENTS AND METHODS
nextMONARCH is an open-label, controlled, randomized, phase II study of women with endocrine-refractory HR + , HER2 - MBC previously treated with chemotherapy. Patients received abemaciclib 150 mg plus tamoxifen 20 mg (A+T), abemaciclib 150 mg every 12 hours (A-150), or abemaciclib 200 mg plus prophylactic loperamide (A-200). The primary objective was progression-free survival (PFS). PFS analyses tested superiority of A+T to A-200 and informal noninferiority of A-150 to A-200. The secondary objectives included the objective response rate (ORR), safety, and pharmacokinetics.
RESULTS
The median PFS was 9.1 months for A+T versus 7.4 months for A-200 (hazard ratio, 0.815; 95% confidence interval, 0.556-1.193; P = .293). The A-200 PFS was comparable to that with A-150 at 6.5 months (hazard ratio, 1.045; 95% confidence interval, 0.711-1.535; P = .811). The ORR was 34.6%, 24.1%, and 32.5% for A+T, A-150, and A-200, respectively. No new safety signals were identified. The incidence and severity of diarrhea (62.3%; grade 3, 7.8%) with A-200 was similar to that with A-150 (67.1%; grade 3, 3.8%). The pharmacokinetics were comparable to previous observations.
CONCLUSIONS
The addition of tamoxifen to abemaciclib did not significantly improve PFS or ORR compared with abemaciclib monotherapy but confirmed the single-agent activity of abemaciclib in heavily pretreated HR + , HER2 - MBC. Dose reductions and antidiarrheal medication generally managed diarrhea while maintaining efficacy.",2020,"The addition of tamoxifen to abemaciclib did not significantly improve PFS or ORR compared with abemaciclib monotherapy but confirmed the single-agent activity of abemaciclib in heavily pretreated HR + , HER2 - MBC.","['endocrine refractory metastatic breast cancer (MBC) after chemotherapy', 'women with endocrine-refractory HR + , HER2 - MBC previously treated with', 'Metastatic Breast Cancer']","['Tamoxifen', 'abemaciclib 150 mg plus tamoxifen 20 mg (A+T), abemaciclib 150 mg every 12 hours (A-150), or abemaciclib 200 mg plus prophylactic loperamide (A-200', 'tamoxifen', 'nextMONARCH evaluated abemaciclib monotherapy (with or without prophylactic loperamide', 'chemotherapy']","['PFS or ORR', 'incidence and severity of diarrhea', 'ORR', 'objective response rate (ORR), safety, and pharmacokinetics', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0065839', 'cui_str': 'Carbendazim'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C4529627', 'cui_str': 'abemaciclib 150 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1126289', 'cui_str': 'Tamoxifen 20 MG'}, {'cui': 'C0585327', 'cui_str': 'Every twelve hours'}, {'cui': 'C0050286', 'cui_str': 'A 150 (plastic)'}, {'cui': 'C4529631', 'cui_str': 'abemaciclib 200 MG'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.171722,"The addition of tamoxifen to abemaciclib did not significantly improve PFS or ORR compared with abemaciclib monotherapy but confirmed the single-agent activity of abemaciclib in heavily pretreated HR + , HER2 - MBC.","[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Hamilton', 'Affiliation': 'Breast and Gynecologic Research Program, Sarah Cannon Research Institute, Tennessee Oncology PLLC, Nashville, TN. Electronic address: ehamilton@tnonc.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': ""Ramón y Cajal University Hospital, Madrid, Spain; Breast Cancer and Melanoma Group, Oncology Department, Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Ozyilkan', 'Affiliation': 'Department of Medical Oncology, Baskent University, Adana, Turkey.'}, {'ForeName': 'Shin-Cheh', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Chang Gung Memorial Hospital, Chang Gung University, Linkou, Taoyuan City, Taiwan.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Petrakova', 'Affiliation': 'Department of Comprehensive Cancer Care, Masarykuv Onkologický Ustav, Brno, Czech Republic.'}, {'ForeName': 'Aleksey', 'Initials': 'A', 'LastName': 'Manikhas', 'Affiliation': 'Breast Cancer Department, City Clinical Oncology Center, St. Petersburg, Russia.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Jerusalem', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier Universitaire, Liège, and Liège University, Liège, Belgium.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'Hospital Pérola Byington/FMUSP, Centro de Referência da Saúde da Mulher, São Paulo, Brazil.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Breast Center, Department of Obstetrics & Gynecology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Sonya C', 'Initials': 'SC', 'LastName': 'Chapman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN.'}, {'ForeName': 'Molly C', 'Initials': 'MC', 'LastName': 'Hardebeck', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Bear', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Johnston', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigación Sanitaria Gregorio Marañón, Universidad Complutense, CIBERONC, GEICAM, Madrid, Spain.'}]",Clinical breast cancer,['10.1016/j.clbc.2020.09.011']
1986,33148481,Interaction of serum calcium and folic acid treatment on first stroke in hypertensive males.,"BACKGROUND & AIMS
The role of serum calcium on the risk of stroke is still uncertain. We aimed to evaluate the effect of serum calcium on first stroke risk, and on the efficacy of folic acid treatment in prevention of first stroke among hypertensive patients.
METHODS
Our analyses included a total of 19,644 eligible hypertensive adults from the China Stroke Primary Prevention Trial (CSPPT). In the CSPPT, a total of 20,702 hypertensive patients were randomly assigned to a double-blind, daily treatment with either 10 mg enalapril and 0.8 mg folic acid or 10 mg enalapril alone. The primary outcome was a first stroke.
RESULTS
Over a median of 4.5 years, among those not receiving folic acid, a significantly higher risk of first stroke was found in hypertensive males with baseline albumin-corrected serum calcium ≥2.43 mmol/L (median) (vs. <2.43 mmol/L; 6.5% vs. 2.3%; adjusted HR, 2.47; 95% CI: 1.72, 3.55). For those with enalapril and folic acid treatment, compared with the enalapril only group, the risk of first stroke was reduced from 6.5% to 3.0% (adjusted HR, 0.49; 95% CI: 0.35, 0.68) in hypertensive males with baseline albumin-corrected serum calcium ≥2.43 mmol/L, whereas there was no significant effect among hypertensive males with baseline albumin-corrected serum calcium <2.43 mmol/L. However, among hypertensive females, serum calcium did not significantly affect the first stroke risk and the efficacy of folic acid in prevention of first stroke.
CONCLUSIONS
Among Chinese hypertensive males, those with elevated serum calcium levels had increased risk of first stroke, and this risk was reduced by 51% with folic acid treatment.",2020,"However, among hypertensive females, serum calcium did not significantly affect the first stroke risk and the efficacy of folic acid in prevention of first stroke.
","['hypertensive males', '20,702 hypertensive patients', 'Chinese hypertensive males', 'hypertensive patients', '19,644 eligible hypertensive adults from the China Stroke Primary Prevention Trial (CSPPT']","['folic acid', 'folic acid treatment', 'enalapril and folic acid', 'serum calcium and folic acid treatment', 'serum calcium', 'enalapril and 0.8\xa0mg folic acid or 10\xa0mg enalapril alone', 'enalapril']","['first stroke', 'risk of first stroke']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C4517481', 'cui_str': '0.8'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",20702.0,0.0502796,"However, among hypertensive females, serum calcium did not significantly affect the first stroke risk and the efficacy of folic acid in prevention of first stroke.
","[{'ForeName': 'Hongxu', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; National Clinical Research Center for Kidney Disease, Guangzhou 510515, China; State Key Laboratory for Organ Failure Research, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou 510515, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China; Institute for Biomedicine, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; National Clinical Research Center for Kidney Disease, Guangzhou 510515, China; State Key Laboratory for Organ Failure Research, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou 510515, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; National Clinical Research Center for Kidney Disease, Guangzhou 510515, China; State Key Laboratory for Organ Failure Research, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou 510515, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing 100034, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing 100034, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': 'Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; National Clinical Research Center for Kidney Disease, Guangzhou 510515, China; State Key Laboratory for Organ Failure Research, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou 510515, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; National Clinical Research Center for Kidney Disease, Guangzhou 510515, China; State Key Laboratory for Organ Failure Research, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou 510515, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Institute for Biomedicine, Anhui Medical University, Hefei 230032, China; Shenzhen Evergreen Medical Institute, Shenzhen 518057, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD 21205-2179, USA.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing 100034, China.'}, {'ForeName': 'Fan Fan', 'Initials': 'FF', 'LastName': 'Hou', 'Affiliation': 'Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; National Clinical Research Center for Kidney Disease, Guangzhou 510515, China; State Key Laboratory for Organ Failure Research, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou 510515, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; National Clinical Research Center for Kidney Disease, Guangzhou 510515, China; State Key Laboratory for Organ Failure Research, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou 510515, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China. Electronic address: xipingxu126@126.com.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; National Clinical Research Center for Kidney Disease, Guangzhou 510515, China; State Key Laboratory for Organ Failure Research, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou 510515, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China. Electronic address: pharmaqin@126.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.033']
1987,33146438,"Functional electrical stimulation cycling, goal-directed training, and adapted cycling for children with cerebral palsy: a randomized controlled trial.","AIM
To test the efficacy of functional electrical stimulation (FES) cycling, goal-directed training, and adapted cycling, compared with usual care, to improve function in children with cerebral palsy (CP).
METHOD
The intervention was delivered between 2017 and 2019 and included three sessions per week for 8 weeks (2×1h sessions at a children's hospital, and 1h home programme/week). Hospital sessions included 30 minutes of FES cycling and 30 minutes of goal-directed training. Home programmes included goal-directed training and adapted cycling. The comparison group continued usual care. Primary outcomes were gross motor function assessed by the Gross Motor Function Measure (GMFM) and goal performance/satisfaction assessed using the Canadian Occupational Performance Measure (COPM). Secondary outcomes were sit-to-stand and activity capacity, participation in home, school, and community activities, and power output. Linear regression was used to determine the between-group mean difference immediately post-training completion after adjusting for baseline scores.
RESULTS
This randomized controlled trial included 21 participants (mean age=10y 3mo, standard deviation [SD]=3y; Gross Motor Function Classification System level: II=7, III=6, IV=8) who were randomized to the intervention (n=11) or usual care group (n=10). Between-group differences at T2 favoured the intervention group for GMFM-88 (mean difference=7.4; 95% confidence interval [CI]: 2.3-12.6; p=0.007), GMFM-66 (mean difference=5.9; 95% CI: 3.1-8.8; p<0.001), COPM performance (mean difference=4.4; 95% CI: 3.9-5.3; p<0.001) and satisfaction (mean difference=5.2; 95% CI: 4.0-6.4; p<0.001).
INTERPRETATION
Children with CP achieved meaningful functional improvements after FES cycling, goal-directed training, and adapted cycling training. Cycling programmes for children with CP should be individualized and goal directed.",2020,"Between-group differences at T2 favoured the intervention group for GMFM-88 (mean difference=7.4; 95% confidence interval [CI]: 2.3-12.6; p=0.007), GMFM-66 (mean difference=5.9; 95% CI: 3.1-8.8; p<0.001), COPM performance (mean difference=4.4; 95% CI: 3.9-5.3; p<0.001) and satisfaction (mean difference=5.2; 95% CI: 4.0-6.4; p<0.001).
","['children with cerebral palsy (CP', 'children with cerebral palsy', 'children with CP', '21 participants (mean age=10y 3mo, standard deviation [SD]=3y; Gross Motor Function Classification System level: II=7, III=6, IV=8) who were randomized to the intervention (n=11) or usual care group (n=10']","['functional electrical stimulation (FES) cycling, goal-directed training, and adapted cycling, compared with usual care', 'Functional electrical stimulation cycling, goal-directed training, and adapted cycling', 'FES cycling and 30 minutes of goal-directed training']","['COPM performance', 'sit-to-stand and activity capacity, participation in home, school, and community activities, and power output', 'gross motor function assessed by the Gross Motor Function Measure (GMFM) and goal performance/satisfaction assessed using the Canadian Occupational Performance Measure (COPM', 'GMFM-66']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",21.0,0.105252,"Between-group differences at T2 favoured the intervention group for GMFM-88 (mean difference=7.4; 95% confidence interval [CI]: 2.3-12.6; p=0.007), GMFM-66 (mean difference=5.9; 95% CI: 3.1-8.8; p<0.001), COPM performance (mean difference=4.4; 95% CI: 3.9-5.3; p<0.001) and satisfaction (mean difference=5.2; 95% CI: 4.0-6.4; p<0.001).
","[{'ForeName': 'Ellen L', 'Initials': 'EL', 'LastName': 'Armstrong', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Roslyn N', 'Initials': 'RN', 'LastName': 'Boyd', 'Affiliation': ""The Queensland Cerebral Palsy Rehabilitation Research Centre, Centre for Children's Health Research, Faculty of Medicine, The University of Queensland, South Brisbane, QLD, Australia.""}, {'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Horan', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Megan J', 'Initials': 'MJ', 'LastName': 'Kentish', 'Affiliation': ""The Queensland Cerebral Palsy Rehabilitation Research Centre, Centre for Children's Health Research, Faculty of Medicine, The University of Queensland, South Brisbane, QLD, Australia.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Ware', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Carty', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Gold Coast, QLD, Australia.'}]",Developmental medicine and child neurology,['10.1111/dmcn.14648']
1988,33146620,Effect of the Pregnant+ Smartphone App on the Dietary Behavior of Women With Gestational Diabetes Mellitus: Secondary Analysis of a Randomized Controlled Trial.,"BACKGROUND
The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. A healthy diet and stable blood glucose levels during pregnancy can prevent adverse health outcomes for the mother and the newborn child. Mobile health may be a useful supplement to prenatal care, providing women with targeted dietary information concerning GDM.
OBJECTIVE
We analyzed secondary data from a two-arm, multicentered, nonblinded randomized controlled trial to determine if a smartphone app with targeted dietary information and blood glucose monitoring had an effect on the dietary behavior of women with GDM.
METHODS
Women with a 2-hour oral glucose tolerance test level of ≥9 mmol/L were individually randomized to either the intervention group receiving the Pregnant+ app and usual care or the control group receiving usual care only. Eligible women were enrolled from 5 diabetes outpatient clinics in the Oslo region, Norway, between October 2015 and April 2017. The Pregnant+ app promoted 10 GDM-specific dietary recommendations. A healthy dietary score for Pregnant+ (HDS-P+) was constructed from a 41-item food frequency questionnaire and used to assess the intervention effect on the dietary behavior completed at trial entry and at around gestation week 36. Dietary changes from baseline to week 36 were examined by a paired sample two-tailed t test. Between-group dietary differences after the intervention were estimated with analysis of covariance, with adjustment for baseline diet.
RESULTS
A total of 238 women participated: 115 were allocated to the intervention group and 123 to the control group. Of the 238 women, 193 (81.1%) completed the food frequency questionnaire both at baseline and around gestational week 36. All the participants showed improvements in their HDS-P+ from baseline. However, the Pregnant+ app did not have a significant effect on their HDS-P+. The control group reported a higher weekly frequency of choosing fish meals (P=.05). No other significant differences were found between the intervention and control groups. There were no significant demographic baseline differences between the groups, except that more women in the intervention group had a non-Norwegian language as their first language (61 vs 46; P=.02).
CONCLUSIONS
Our findings do not support the supplementation of face-to-face follow-up of women with GDM with a smartphone app in the presence of high-standard usual care, as the Pregnant+ app did not have a beneficial effect on pregnant women's diet.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02588729; https://clinicaltrials.gov/ct2/show/NCT02588729.",2020,The control group reported a higher weekly frequency of choosing fish meals (P=.05).,"['A total of 238 women participated: 115', '238 women, 193 (81.1%) completed the food frequency questionnaire both at baseline and around gestational week 36', 'Women With Gestational Diabetes Mellitus', 'Eligible women were enrolled from 5 diabetes outpatient clinics in the Oslo region, Norway, between October 2015 and April 2017', 'Women with a 2-hour oral glucose tolerance test level of ≥9 mmol/L', 'gestational diabetes mellitus (GDM']","['smartphone app with targeted dietary information and blood glucose monitoring', 'intervention group receiving the Pregnant+ app and usual care or the control group receiving usual care only', 'Pregnant+ Smartphone App']","['Dietary Behavior', 'non-Norwegian language as their first language']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0557073', 'cui_str': 'First language'}]",238.0,0.102724,The control group reported a higher weekly frequency of choosing fish meals (P=.05).,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Garnweidner-Holme', 'Affiliation': 'OsloMet - Oslo Metropolitan University of Applied Sciences, Oslo, Norway.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Henriksen', 'Affiliation': 'OsloMet - Oslo Metropolitan University of Applied Sciences, Oslo, Norway.'}, {'ForeName': 'Liv Elin', 'Initials': 'LE', 'LastName': 'Torheim', 'Affiliation': 'OsloMet - Oslo Metropolitan University of Applied Sciences, Oslo, Norway.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Lukasse', 'Affiliation': 'OsloMet - Oslo Metropolitan University of Applied Sciences, Oslo, Norway.'}]",JMIR mHealth and uHealth,['10.2196/18614']
1989,33146624,"Length of Initial Prescription at Hospital Discharge and Long-Term Medication Adherence for Elderly, Post-Myocardial Infarction Patients: Protocol for an Interrupted Time Series Study.","BACKGROUND
Based on high-quality evidence, guidelines recommend the long-term use of secondary prevention medications post-myocardial infarction (MI) to avoid recurrent cardiovascular events and death. Unfortunately, discontinuation of recommended medications post-MI is common. Observational evidence suggests that prescriptions covering a longer duration at discharge from hospital are associated with greater long-term medication adherence. The following is a proposal for the first interventional study to evaluate the impact of longer prescription duration at discharge post-MI on long-term medication adherence.
OBJECTIVE
The overarching goal of this study is to reduce morbidity and mortality among post-MI patients through improved long-term cardiac medication adherence. The specific objectives include the following. First, we will assess whether long-term cardiac medication adherence improves among elderly, post-MI patients following the implementation of (1) standardized discharge prescription forms with 90-day prescriptions and 3 repeats for recommended cardiac medication classes, in combination with education and (2) education alone compared to (3) usual care. Second, we will assess the cost implications of prolonged initial discharge prescriptions compared with usual care. Third, we will compare clinical outcomes between longer (>60 days) versus shorter prescription durations. Fourth, we will collect baseline information to inform a multicenter interventional study.
METHODS
We will conduct a quasiexperimental, interrupted time series design to evaluate the impact of a multifaceted intervention to implement longer duration prescriptions versus usual care on long-term cardiac medication adherence among post-MI patients. Intervention groups and their corresponding settings include: (1) intervention group 1: 1 cardiac center and 1 noncardiac hospital allocated to receive standardized discharge prescription forms supporting the dispensation of 90 days' worth of cardiac medications with 3 repeats, coupled with education; (2) intervention group 2: 4 sites (including 1 cardiac center) allocated to receive education only; and (3) control group: all remaining hospitals within the province that did not receive an intervention (ie, usual care). Administrative databases will be used to measure all outcomes. Adherence to 4 classes of cardiac medications - statins, beta blockers, angiotensin system inhibitors, and secondary antiplatelets (ie, prasugrel, clopidogrel, or ticagrelor) - will be assessed.
RESULTS
Enrollment began in September 2017, and results are expected to be analyzed in late 2020.
CONCLUSIONS
The results have the potential to redefine best practices regarding discharge prescribing policies for patients post-MI. A policy of standardized maximum-duration prescriptions at the time of discharge post-MI is a simple intervention that has the potential to significantly improve long-term medication adherence, thus decreasing cardiac morbidity and mortality. If effective, this low-cost intervention to implement longer duration prescriptions post-MI could be easily scaled.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03257579; https://clinicaltrials.gov/ct2/show/NCT03257579.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/18981.",2020,"The following is a proposal for the first interventional study to evaluate the impact of longer prescription duration at discharge post-MI on long-term medication adherence.
","['Elderly, Post-Myocardial Infarction Patients', 'post-MI patients', 'elderly, post-MI patients following the implementation of (1) standardized discharge prescription forms with 90-day prescriptions and 3 repeats for recommended cardiac medication classes, in']","['combination with education and (2) education alone compared to (3) usual care', ""Intervention groups and their corresponding settings include: (1) intervention group 1: 1 cardiac center and 1 noncardiac hospital allocated to receive standardized discharge prescription forms supporting the dispensation of 90 days' worth of cardiac medications with 3 repeats, coupled with education; (2) intervention group 2: 4 sites (including 1 cardiac center) allocated to receive education only; and (3) control group: all remaining hospitals within the province that did not receive an intervention (ie, usual care"", 'cardiac medications - statins, beta blockers, angiotensin system inhibitors, and secondary antiplatelets (ie, prasugrel, clopidogrel, or ticagrelor']","['morbidity and mortality', 'Length of Initial Prescription at Hospital Discharge and Long-Term Medication Adherence', 'cardiac morbidity and mortality']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",,0.110536,"The following is a proposal for the first interventional study to evaluate the impact of longer prescription duration at discharge post-MI on long-term medication adherence.
","[{'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Schwalm', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Ivers', 'Affiliation': ""Family Practice Health Centre, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Bouck', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Madhu K', 'Initials': 'MK', 'LastName': 'Natarajan', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dolovich', 'Affiliation': 'Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Kednapa', 'Initials': 'K', 'LastName': 'Thavorn', 'Affiliation': 'ICES, Toronto, ON, Canada.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'McCready', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': ""O'Brien"", 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.'}]",JMIR research protocols,['10.2196/18981']
1990,33146667,Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial.,"Importance
Major depressive disorder (MDD) is a substantial public health burden, but current treatments have limited effectiveness and adherence. Recent evidence suggests that 1 or 2 administrations of psilocybin with psychological support produces antidepressant effects in patients with cancer and in those with treatment-resistant depression.
Objective
To investigate the effect of psilocybin therapy in patients with MDD.
Design, Setting, and Participants
This randomized, waiting list-controlled clinical trial was conducted at the Center for Psychedelic and Consciousness Research at Johns Hopkins Bayview Medical Center in Baltimore, Maryland. Adults aged 21 to 75 years with an MDD diagnosis, not currently using antidepressant medications, and without histories of psychotic disorder, serious suicide attempt, or hospitalization were eligible to participate. Enrollment occurred between August 2017 and April 2019, and the 4-week primary outcome assessments were completed in July 2019. A total of 27 participants were randomized to an immediate treatment condition group (n = 15) or delayed treatment condition group (waiting list control condition; n = 12). Data analysis was conducted from July 1, 2019, to July 31, 2020, and included participants who completed the intervention (evaluable population).
Interventions
Two psilocybin sessions (session 1: 20 mg/70 kg; session 2: 30 mg/70 kg) were given (administered in opaque gelatin capsules with approximately 100 mL of water) in the context of supportive psychotherapy (approximately 11 hours). Participants were randomized to begin treatment immediately or after an 8-week delay.
Main Outcomes and Measures
The primary outcome, depression severity was assessed with the GRID-Hamilton Depression Rating Scale (GRID-HAMD) scores at baseline (score of ≥17 required for enrollment) and weeks 5 and 8 after enrollment for the delayed treatment group, which corresponded to weeks 1 and 4 after the intervention for the immediate treatment group. Secondary outcomes included the Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR).
Results
Of the randomized participants, 24 of 27 (89%) completed the intervention and the week 1 and week 4 postsession assessments. This population had a mean (SD) age of 39.8 (12.2) years, was composed of 16 women (67%), and had a mean (SD) baseline GRID-HAMD score of 22.8 (3.9). The mean (SD) GRID-HAMD scores at weeks 1 and 4 (8.0 [7.1] and 8.5 [5.7]) in the immediate treatment group were statistically significantly lower than the scores at the comparable time points of weeks 5 and 8 (23.8 [5.4] and 23.5 [6.0]) in the delayed treatment group. The effect sizes were large at week 5 (Cohen d = 2.2; 95% CI, 1.4-3.0; P < .001) and week 8 (Cohen d = 2.6; 95% CI, 1.7-3.6; P < .001). The QIDS-SR documented a rapid decrease in mean (SD) depression score from baseline to day 1 after session 1 (16.7 [3.5] vs 6.3 [4.4]; Cohen d = 3.0; 95% CI, 1.9-4.0; P < .001), which remained statistically significantly reduced through the week 4 follow-up (6.0 [5.7]; Cohen d = 3.1; 95% CI, 1.9-4.2; P < .001). In the overall sample, 16 participants (67%) at week 1 and 17 (71%) at week 4 had a clinically significant response to the intervention (≥50% reduction in GRID-HAMD score), and 14 participants (58%) at week 1 and 13 participants (54%) at week 4 were in remission (≤7 GRID-HAMD score).
Conclusions and Relevance
Findings suggest that psilocybin with therapy is efficacious in treating MDD, thus extending the results of previous studies of this intervention in patients with cancer and depression and of a nonrandomized study in patients with treatment-resistant depression.
Trial Registration
ClinicalTrials.gov Identifier: NCT03181529.",2020,"The effect sizes were large at week 5 (Cohen d = 2.2; 95% CI, 1.4-3.0; P < .001) and week 8 (Cohen d = 2.6; 95% CI, 1.7-3.6; P < .001).","['patients with cancer and in those with treatment-resistant depression', 'This population had a mean (SD) age of 39.8 (12.2) years, was composed of 16 women (67%), and had a mean (SD) baseline GRID-HAMD score of 22.8 (3.9', 'patients with MDD', 'Data analysis was conducted from July 1, 2019, to July 31, 2020, and included participants who completed the intervention (evaluable population', 'Adults aged 21 to 75 years with an MDD diagnosis, not currently using antidepressant medications, and without histories of psychotic disorder, serious suicide attempt, or hospitalization were eligible to participate', 'patients with cancer and depression and of a nonrandomized study in patients with treatment-resistant depression', 'Center for Psychedelic and Consciousness Research at Johns Hopkins Bayview Medical Center in Baltimore, Maryland', '27 participants', 'Major Depressive Disorder']","['psilocybin therapy', 'psilocybin sessions', 'immediate treatment condition group (n = 15) or delayed treatment condition group (waiting list control condition', 'opaque gelatin capsules with approximately 100 mL of water) in the context of supportive psychotherapy', 'Psilocybin-Assisted Therapy', 'psilocybin']","['mean (SD) GRID-HAMD scores', 'GRID-Hamilton Depression Rating Scale (GRID-HAMD) scores', 'mean (SD) depression score', 'Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR', 'depression severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3887134', 'cui_str': 'History of psychotic disorder'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018533', 'cui_str': 'Hallucinogen'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3693346', 'cui_str': 'Treatment Delay'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029053', 'cui_str': 'Decreased translucency'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",27.0,0.237731,"The effect sizes were large at week 5 (Cohen d = 2.2; 95% CI, 1.4-3.0; P < .001) and week 8 (Cohen d = 2.6; 95% CI, 1.7-3.6; P < .001).","[{'ForeName': 'Alan K', 'Initials': 'AK', 'LastName': 'Davis', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Frederick S', 'Initials': 'FS', 'LastName': 'Barrett', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Darrick G', 'Initials': 'DG', 'LastName': 'May', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Mary P', 'Initials': 'MP', 'LastName': 'Cosimano', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Nathan D', 'Initials': 'ND', 'LastName': 'Sepeda', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Johnson', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Patrick H', 'Initials': 'PH', 'LastName': 'Finan', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Roland R', 'Initials': 'RR', 'LastName': 'Griffiths', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.3285']
1991,33146693,Effect of Cognitive Bias Modification on Early Relapse Among Adults Undergoing Inpatient Alcohol Withdrawal Treatment: A Randomized Clinical Trial.,"Importance
More than half of patients with alcohol use disorder who receive inpatient withdrawal treatment relapse within weeks of discharge, hampering subsequent uptake and effectiveness of psychological and pharmacologic interventions. Cognitive bias modification (CBM) improves outcomes after alcohol rehabilitation, but the efficacy of delivering CBM during withdrawal treatment has not yet been established.
Objective
To test the hypothesis that CBM would increase the likelihood of abstaining from alcohol during the 2 weeks following discharge from inpatient withdrawal treatment.
Design, Setting, and Participants
In a randomized clinical trial, 950 patients in 4 inpatient withdrawal units in Melbourne, Australia, were screened for eligibility between June 4, 2017, and July 14, 2019, to receive CBM or sham treatment. Patients with moderate or severe alcohol use disorder aged 18 to 65 years who had no neurologic illness or traumatic brain injury were eligible. Two-week follow-up, conducted by researchers blinded to the participant's condition, was the primary end point. Both per-protocol and intention-to-treat analysis were conducted.
Interventions
Randomized to 4 consecutive daily sessions of CBM designed to reduce alcohol approach bias or sham training not designed to modify approach bias.
Main Outcomes and Measures
Primary outcome was abstinence assessed using a timeline followback interview. Participants were classified as abstinent (no alcohol use in the first 14 days following discharge) or relapsed (any alcohol use during the first 14 days following discharge or lost to follow-up).
Results
Of the 950 patients screened for eligibility, 338 did not meet inclusion criteria, 108 were discharged before being approached, and 192 refused. Of the 312 patients who consented (referred sample), 12 withdrew before being randomized. In the final population of 300 randomized patients (CBM, n = 147; sham, n = 153), 248 completed the intervention and 272 completed the follow-up. Of the 300 participants (173 [57.7%] men; mean [SD] age, 43.47 [10.43] years), 7 patients (3 controls, 4 CBM) withdrew after finding the training uncomfortable. Abstinence rates were 42.5% (95% CI, 34.3%-50.6%) in controls and 54.4% (95% CI, 46.0%-62.8%) in CBM participants, yielding an 11.9% (95% CI, 0.04%-23.8%; P = .04) difference in abstinence rates. In a per-protocol analysis including only those who completed 4 sessions of training and the follow-up, the difference in abstinence rate between groups was 17.0% (95% CI, 3.8%-30.2%; P = .008).
Conclusions and Relevance
The findings of this clinical trial support the efficacy of CBM for treatment of alcohol use disorder. Being safe and easy to implement, requiring only a computer and joystick, and needing no specialist staff/training, CBM could be routinely offered as an adjunctive intervention during withdrawal treatment to optimize outcomes.
Trial Registration
Australian New Zealand Clinical Trials Registry Identifier: ACTRN12617001241325.",2020,"Abstinence rates were 42.5% (95% CI, 34.3%-50.6%) in controls and 54.4% (95% CI, 46.0%-62.8%) in CBM participants, yielding an 11.9% (95% CI, 0.04%-23.8%; P = .04) difference in abstinence rates.","['Patients with moderate or severe alcohol use disorder aged 18 to 65 years who had no neurologic illness or traumatic brain injury were eligible', '950 patients in 4 inpatient withdrawal units in Melbourne, Australia, were screened for eligibility between June 4, 2017, and July 14, 2019, to receive CBM or sham treatment', 'Undergoing Inpatient Alcohol Withdrawal Treatment', 'Participants were classified as abstinent (no alcohol use in the first 14 days following discharge) or relapsed (any alcohol use during the first 14 days following discharge or lost to follow-up', '950 patients screened for eligibility', '300 participants (173 [57.7%] men; mean [SD] age, 43.47 [10.43] years), 7 patients (3 controls, 4 CBM) withdrew after finding the training uncomfortable', '312 patients who consented (referred sample), 12 withdrew before being randomized', '300 randomized patients (CBM, n\u2009=\u2009147; sham, n\u2009=\u2009153), 248 completed the intervention and 272 completed the follow-up', 'Adults']","['CBM', 'Cognitive bias modification (CBM', 'Cognitive Bias Modification']","['abstinence rates', 'abstinence assessed using a timeline followback interview', 'abstinence rate', 'Abstinence rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0236663', 'cui_str': 'Alcohol withdrawal syndrome'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]",950.0,0.275571,"Abstinence rates were 42.5% (95% CI, 34.3%-50.6%) in controls and 54.4% (95% CI, 46.0%-62.8%) in CBM participants, yielding an 11.9% (95% CI, 0.04%-23.8%; P = .04) difference in abstinence rates.","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Manning', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Joshua B B', 'Initials': 'JBB', 'LastName': 'Garfield', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Petra K', 'Initials': 'PK', 'LastName': 'Staiger', 'Affiliation': 'Deakin University School of Psychology, Geelong, Victoria, Australia.'}, {'ForeName': 'Dan I', 'Initials': 'DI', 'LastName': 'Lubman', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jarrad A G', 'Initials': 'JAG', 'LastName': 'Lum', 'Affiliation': 'Deakin University School of Psychology, Geelong, Victoria, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Reynolds', 'Affiliation': 'Alfred Health and Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hall', 'Affiliation': 'Deakin University School of Psychology, Geelong, Victoria, Australia.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Bonomo', 'Affiliation': ""Department of Addiction Medicine, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Lloyd-Jones', 'Affiliation': ""Department of Addiction Medicine, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Reinout W', 'Initials': 'RW', 'LastName': 'Wiers', 'Affiliation': 'Addiction Development and Psychopathology Lab, Center for Urban Mental Health, Department of Psychology, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Piercy', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jacka', 'Affiliation': 'Monash Health Drug and Alcohol Service, Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Verdejo-Garcia', 'Affiliation': 'Turning Point, Eastern Health, Melbourne, Victoria, Australia.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.3446']
1992,33146774,[Schirmer's test and strip meniscometry : Comparative consideration in the diagnostics of dry eye].,"BACKGROUND
As one alternative to the Schirmer test, strip meniscometry has been presented as a methodology which also seems to be suitable for quantifying a lack of tear volume.
METHODS
In a randomized prospective clinical study 391 eyes from 201 subjects were assigned to 3 groups according to the severity of eye surface deficiency (group 0: 225 healthy eyes, f/m = 1.25, mean age = 50.1 ± 17.6 years; group 1: 112 eyes with mild keratoconjunctivitis sicca (KCS), f/m = 1.38, mean age = 58.7 ± 13.9 years; group 2: 54 eyes with manifest KCS, f/m = 2.375, mean age = 52.6 ± 14.1 years). Objective test parameters used were strip meniscometry, Schirmer's 1 test and the Jones-test. In order to determine the condition of the ocular surface and tear film more precisely, slit-lamp examination, the detection of lid-parallel conjunctival folds (LIPCOF) and optical coherence tomography (OCT) meniscometry were also performed. Subjective discomfort was objectified by using the Ocular Surface Disease Index questionnaire (OSDI).
RESULTS
The results of strip meniscometry, Schirmer's 1 test, the Jones test and OCT meniscometry were significantly lower in KCS subjects than in healthy subjects (p < 0.001), whereas the OSDI score was significantly higher (p < 0.001). The parameters strip meniscometry, Schirmer's 1 test, the Jones test and OCT meniscometry scores correlated with each other. Sensitivity and specificity of strip meniscometry ranged from 0.79 to 0.89 and from 0.42 to 0.5.
CONCLUSION
Strip meniscometry is suitable to detect a lack of tear volume. Advantageous is the rapid performance of the procedure (5 s per eye) and a good agreement with established tests (e.g. Schirmer's test). To improve the specificity, strip meniscometry must be combined with other examination methods.",2020,"Sensitivity and specificity of strip meniscometry ranged from 0.79 to 0.89 and from 0.42 to 0.5.
","['391 eyes from 201 subjects were assigned to 3 groups according to the severity of eye surface deficiency (group 0: 225 healthy eyes, f/m\u202f=\u20091.25, mean age\u202f=\u200950.1\u202f±\u200917.6 years; group 1: 112 eyes with mild keratoconjunctivitis sicca (KCS), f/m\u202f=\u20091.38, mean age\u202f=\u200958.7\u202f±\u200913.9 years; group 2: 54 eyes with manifest KCS, f/m\u202f=\u20092.375, mean age\u202f=\u200952.6\u202f±\u200914.1 years']",[],"['OSDI score', 'Jones test and OCT meniscometry scores', 'Ocular Surface Disease Index questionnaire (OSDI', 'detection of lid-parallel conjunctival folds (LIPCOF) and optical coherence tomography (OCT) meniscometry', 'Sensitivity and specificity of strip meniscometry', 'Jones test and OCT meniscometry', 'Subjective discomfort']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}]",[],"[{'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0459665', 'cui_str': 'Structure of conjunctival fold'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",391.0,0.0132538,"Sensitivity and specificity of strip meniscometry ranged from 0.79 to 0.89 and from 0.42 to 0.5.
","[{'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Schulze', 'Affiliation': 'Augenheilkunde, Universitätsmedizin Greifswald, F.-Sauerbruch-Str., 17475, Greifswald, Deutschland. konrad.schulze@med.uni-greifswald.de.'}, {'ForeName': 'Rico', 'Initials': 'R', 'LastName': 'Großjohann', 'Affiliation': 'Augenheilkunde, Universitätsmedizin Greifswald, F.-Sauerbruch-Str., 17475, Greifswald, Deutschland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'Augenheilkunde, Universitätsmedizin Greifswald, F.-Sauerbruch-Str., 17475, Greifswald, Deutschland.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Bossaller', 'Affiliation': 'Rheumatologie, Universitätsmedizin Greifswald, Greifswald, Deutschland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tost', 'Affiliation': 'Augenheilkunde, Universitätsmedizin Greifswald, F.-Sauerbruch-Str., 17475, Greifswald, Deutschland.'}]",Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft,['10.1007/s00347-020-01208-0']
1993,33146811,The modified endoscopic retrograde appendicitis therapy versus antibiotic therapy alone for acute uncomplicated appendicitis in children.,"BACKGROUND
Endoscopic retrograde appendicitis therapy (ERAT) is an emerging endoscopic treatment modality for acute uncomplicated appendicitis (AUA) supported by several case series. However, to date, systematic studies have not been conducted in children and the prospective comparative data are lacking. Moreover, due to a concern for future malignancy risk in children from ionizing radiation, we used contrast-enhanced ultrasound (CEUS) instead of endoscopic retrograde appendiceal radiography (ERAR). Therefore, we conducted a prospective, randomized control clinical trial to compare the modified ERAT (mERAT) to antibiotic therapy in children with AUA. The aim of this study was to evaluate the safety and feasibility and of mERAT in the treatment of hospitalized children with AUA.
METHODS
Children with AUA, confirmed by ultrasonography and or abdominal computed tomography, were consecutively enrolled from October 2018 to February, 2020. They were randomly assigned to receive mERAT or routine antibiotic treatment. Patients were followed until May, 2020. Th primary outcome variable was the duration of relief of the abdominal pain after treatment. We collected patient's demographics, ultrasonic imaging findings, colonoscopy findings, and treatment outcomes of the mERAT and adverse even associated with mERAT.
RESULTS
A total of 83 children were enrolled. 36 were randomized to mERAT and 47 to antibiotics treatment. All children in the mERAT group had endoscopic confirmed acute uncomplicated appendicitis, and there were no significant complications. However, 9 of patients in antibiotic group were poor responsive to treatment and switched to mERAT. The overall success rate of treatment with mERAT (100%) was significantly higher than that of antibiotics (80.9%) (P = 0.004). The median time to discharge was significantly shorter in mERAT group than in antibiotics treatment group [6.0 ± 1.76 days] (P = 0.004).
CONCLUSIONS
mERAT provide a new alternative therapeutic option for childhood with AUA, especially for families who are reluctant to undergo an appendectomy.",2020,"All children in the mERAT group had endoscopic confirmed acute uncomplicated appendicitis, and there were no significant complications.","['children with AUA', 'hospitalized children with AUA', 'Children with AUA, confirmed by ultrasonography and or abdominal computed tomography, were consecutively enrolled from October 2018 to February, 2020', 'acute uncomplicated appendicitis (AUA', '83 children were enrolled', 'acute uncomplicated appendicitis in children']","['endoscopic retrograde appendicitis therapy versus antibiotic therapy alone', 'mERAT', 'Endoscopic retrograde appendicitis therapy (ERAT', 'modified ERAT (mERAT) to antibiotic therapy', 'mERAT or routine antibiotic treatment']","['endoscopic confirmed acute uncomplicated appendicitis', 'duration of relief of the abdominal pain', 'safety and feasibility', 'median time to discharge', 'overall success rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",83.0,0.0503141,"All children in the mERAT group had endoscopic confirmed acute uncomplicated appendicitis, and there were no significant complications.","[{'ForeName': 'Jianqin', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': ""Department of Pediatrics, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, Shaanxi Province, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Pediatrics, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, Shaanxi Province, China.""}, {'ForeName': 'Lingchao', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': ""Department of Pediatrics, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, Shaanxi Province, China. zlc51@163.com.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Department of Pediatrics, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, Shaanxi Province, China.""}, {'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Pediatrics, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, Shaanxi Province, China.""}, {'ForeName': 'Nini', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': ""Department of Pediatrics, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, Shaanxi Province, China.""}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ""Department of Pediatrics, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, Shaanxi Province, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Pediatrics, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, Shaanxi Province, China.""}, {'ForeName': 'Xiangzeng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Pediatrics, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, Shaanxi Province, China.""}, {'ForeName': 'Baoxi', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Department of Pediatrics, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, Shaanxi Province, China.""}, {'ForeName': 'Ruijing', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""Department of Ultrasonics, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, Shaanxi Province, China.""}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Department of Pediatrics, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, Shaanxi Province, China. 863756276@qq.com.""}]",Surgical endoscopy,['10.1007/s00464-020-08129-8']
1994,33146831,Training of vertical versus horizontal reading in patients with hemianopia - a randomized and controlled study.,"HYPOTHESIS
Patients with hemianopic field defects (HFD) might benefit from reading text in vertical orientation if they place the text in the seeing hemifield along the vertical midline.
METHODS
We assigned 21 patients with HFD randomly to either vertical or horizontal reading training. They trained reading single lines of texts from a computer screen at home for 2 × 30 min/day, 5 days/week, for 4 weeks. The main outcome variable was reading speed (RS) during reading standardized paragraphs of printed text (IReST) aloud. RS was assessed before training (T1), directly after training (T2) and 4 weeks later (T3). Quality of life (QoL) was assessed by Impact of Visual Impairment (IVI) questionnaire.
RESULTS
Vertical training improved RS in the vertical direction significantly. Only patients with right HFD benefited. Horizontal training improved RS in horizontal diection significantly, but much more in patients with left than in those with right HFD. Both effects remained stable at T3. RS during training at the computer improved highly significantly and correlated strongly with RS of printed text (Pearson r= > 0.9). QoL: Vertical training showed a statistically significant improvement in the complete IVI-score, patients with right HFD in the emotional IVI-score.
CONCLUSIONS
The improvements of RS were specific for the training. The stable effect indicates that the patients can apply the newly learned strategies to everyday life. The side of the HFD plays an essential role: Left-HFD patients benefitted from horizontal training, right-HFD patients from vertical training. However, the vertical RS did not reach the level of horizontal RS. The study was registered in the German Clinical Trials register (DRKS-ID: DRKS00018843).",2020,"Horizontal training improved RS in horizontal diection significantly, but much more in patients with left than in those with right HFD.","['Left-HFD patients benefitted from horizontal training, right-HFD patients from vertical training', 'Patients with hemianopic field defects (HFD', 'patients with hemianopia ', '21 patients with HFD randomly to either']","['vertical or horizontal reading training', 'Training of vertical versus horizontal reading', 'Horizontal training']","['level of horizontal RS', 'Quality of life (QoL', 'Visual Impairment (IVI) questionnaire', 'complete IVI-score', 'reading speed (RS) during reading standardized paragraphs of printed text (IReST) aloud']","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0018979', 'cui_str': 'Hemianopia'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",21.0,0.0239958,"Horizontal training improved RS in horizontal diection significantly, but much more in patients with left than in those with right HFD.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kuester-Gruber', 'Affiliation': 'Vision Rehabilitation Research Unit, Center for Ophthalmology, University of Tübingen, Tübingen, Germany. Stephan.kuester@uni-tuebingen.de.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kabisch', 'Affiliation': 'Vision Rehabilitation Research Unit, Center for Ophthalmology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cordey', 'Affiliation': 'Vision Rehabilitation Research Unit, Center for Ophthalmology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'H-O', 'Initials': 'HO', 'LastName': 'Karnath', 'Affiliation': 'Center of Neurology, Division of Neuropsychology, Hertie-Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Trauzettel-Klosinski', 'Affiliation': 'Vision Rehabilitation Research Unit, Center for Ophthalmology, University of Tübingen, Tübingen, Germany.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04952-w']
1995,33146922,A Phase I Clinical Trial of Avelumab in Combination with Decitabine as First Line Treatment of Unfit patients with AML.,,2020,,['Unfit patients with AML'],['Decitabine'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]","[{'cui': 'C0049065', 'cui_str': 'decitabine'}]",[],,0.0166821,,"[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Penn State Cancer Institute, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Mineishi', 'Affiliation': 'Penn State Cancer Institute, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Claxton', 'Affiliation': 'Penn State Cancer Institute, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Junjia', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Public Health Sciences, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Penn State Cancer Institute, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Jia', 'Affiliation': 'Penn State Cancer Institute, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'W Christopher', 'Initials': 'WC', 'LastName': 'Ehmann', 'Affiliation': 'Penn State Cancer Institute, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Witold B', 'Initials': 'WB', 'LastName': 'Rybka', 'Affiliation': 'Penn State Cancer Institute, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Naik', 'Affiliation': 'Penn State Cancer Institute, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Natthapol', 'Initials': 'N', 'LastName': 'Songdej', 'Affiliation': 'Penn State Cancer Institute, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Drabick', 'Affiliation': 'Penn State Cancer Institute, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Hohl', 'Affiliation': 'Penn State Cancer Institute, Penn State University College of Medicine, Hershey, PA, USA.'}]",American journal of hematology,['10.1002/ajh.26043']
1996,33146953,Gender-related difference in altered fractional amplitude of low-frequency fluctuations after electroacupuncture on primary insomnia patients: A resting-state fMRI study.,"BACKGROUND
Primary insomnia (PI) is defined as a sleep disorder with no definite cause or inducement. Electroacupuncture, a treatment of inserting needles into specific points on the body surface and applying electrical stimulation, has been proved effective in treating PI with minimal adverse effects. However, the influence of gender difference on the clinical treatment efficacy of electroacupuncture for PI patients remains unclear. Therefore, we designed a clinical trial to compare the clinical treatment efficacy of electroacupuncture for PI patients with different genders. The research on the mechanism of electroacupuncture suggested it could modulate the sleep and wakefulness by activating or deactivating brain regions via a needling/tactile somatosensory specific stimulus. Therefore, we also designed a resting-state functional magnetic resonance imaging (rs-fMRI) study to detect the spontaneous brain activity of PI patients before and after the electroacupuncture treatment.
METHOD
Thirty PI patients were recruited to accept 5-week electroacupuncture treatment on HT-7. Athens Insomnia Scale (AIS) and Pittsburgh sleep quality index (PSQI) questionnaires were used to evaluate the clinical treatment efficacy. Rs-fMRI was employed to observe the spontaneous brain activity in the resting state at the baseline and after 5 weeks of electroacupuncture treatment, which was measured by the fractional amplitude of low-frequency fluctuations (fALFF).
RESULT
The AIS and PSQI scores were significantly decreased both in the female PI group and the male PI group after treatment. The decreased PSQI of female patients was significantly more than that of male patients (p < .05). The gender-related difference in the cerebral response to electroacupuncture was mainly in posterior cingulate and supramarginal gyrus.
CONCLUSION
There is a gender-related difference in the clinical treatment efficacy of electroacupuncture for PI patients, and female patients may benefit more from electroacupuncture. Gender-related differences in the cerebral response to electroacupuncture may be one of the factors affecting clinical treatment efficacy.",2020,"The gender-related difference in the cerebral response to electroacupuncture was mainly in posterior cingulate and supramarginal gyrus.
","['PI patients with different genders', 'primary insomnia patients', 'Thirty PI patients']","['electroacupuncture', 'Electroacupuncture', 'electroacupuncture treatment', 'electroacupuncture treatment on HT-7']","['Athens Insomnia Scale (AIS) and Pittsburgh sleep quality index (PSQI', 'cerebral response', 'PSQI', 'spontaneous brain activity', 'AIS and PSQI scores']","[{'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}]",30.0,0.023089,"The gender-related difference in the cerebral response to electroacupuncture was mainly in posterior cingulate and supramarginal gyrus.
","[{'ForeName': 'Xiao-Hua', 'Initials': 'XH', 'LastName': 'Shi', 'Affiliation': 'Department of Neurology, China-Japan Union Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Yu-Kai', 'Initials': 'YK', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China-Japan Union Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Tie', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, Changchun University of Chinese Medicine, Changchun, China.'}, {'ForeName': 'Hong-Yu', 'Initials': 'HY', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, China-Japan Union Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Xin-Tong', 'Initials': 'XT', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China-Japan Union Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Zhi-Hong', 'Initials': 'ZH', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Changchun University of Chinese Medicine, Changchun, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Mang', 'Affiliation': 'Department of Neurology, China-Japan Union Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Zhong-Xin', 'Initials': 'ZX', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, China-Japan Union Hospital of Jilin University, Changchun, China.'}]",Brain and behavior,['10.1002/brb3.1927']
1997,33150744,Experimentally Manipulated Low Social Status and Food Insecurity Alter Eating Behavior Among Adolescents: A Randomized Controlled Trial.,"OBJECTIVE
This randomized trial experimentally manipulated social status to assess effects on acute eating behavior and 24-hour energy balance.
METHODS
Participants (n = 133 Hispanics; age 15-21 years; 60.2% females) were randomized to low social status (""LOW"") or high social status (""HIGH"") conditions in a rigged game of Monopoly (Hasbro, Inc.). Acute energy intake in a lunchtime meal was measured by food scales. Twenty-four-hour energy balance was assessed via summation of resting metabolic rate (metabolic cart), physical activity energy expenditure (accelerometer), thermic effect of food, and subtraction of twenty-four-hour energy intake (food diary).
RESULTS
In the total sample, no significant differences were observed by study condition at lunchtime. LOW females consumed a greater percent of lunchtime daily energy needs (37.5%) relative to HIGH females (34.3%); however, this difference was not statistically significant (P = 0.291). In males, however, LOW consumed significantly less (36.5%) of their daily energy needs relative to HIGH males (45.8%; P = 0.001). For 24-hour energy balance, sex differences were nearly significant (P = 0.057; LOW females: surplus +200 kcal; HIGH males: surplus +445 kcal). Food-insecure individuals consumed a nearly significant greater lunchtime percent daily energy than those with food security (40.7% vs. 36.3%; P = 0.0797).
CONCLUSIONS
The data demonstrate differential acute and 24-hour eating behavior responses between Hispanic male and female adolescents in experimentally manipulated conditions of low social status.",2020,"LOW females consumed a greater percent of lunchtime daily energy needs (37.5%) relative to HIGH females (34.3%); however, this difference was not statistically significant (P = 0.291).","['Adolescents', 'Hispanic male and female adolescents', 'Participants (n\u2009=\u2009133 Hispanics; age 15-21 years; 60.2% females']","['low social status (""LOW"") or high social status (""HIGH"") conditions in a rigged game of Monopoly (Hasbro, Inc']","['resting metabolic rate (metabolic cart), physical activity energy expenditure (accelerometer), thermic effect of food, and subtraction of twenty-four-hour energy intake (food diary', 'lunchtime percent daily energy', 'lunchtime daily energy needs', '24-hour eating behavior responses', 'Eating Behavior']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0699806', 'cui_str': 'Social status'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0301503', 'cui_str': 'rabies immune globulin, human'}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0179636', 'cui_str': 'Cart'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C0585039', 'cui_str': 'Lunch time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",,0.182323,"LOW females consumed a greater percent of lunchtime daily energy needs (37.5%) relative to HIGH females (34.3%); however, this difference was not statistically significant (P = 0.291).","[{'ForeName': 'Michelle I', 'Initials': 'MI', 'LastName': 'Cardel', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Pavela', 'Affiliation': 'Department of Health Behavior, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Janicke', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Tianyao', 'Initials': 'T', 'LastName': 'Huo', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Darci', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Lee', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gurka', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dhurandhar', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, Texas, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Peters', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Caldwell', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Krause', 'Affiliation': 'Department of Pharmacodynamics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fernandez', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Allison', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University-Bloomington, Bloomington, Indiana, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.23002']
1998,33150745,A Randomized Controlled Trial of Ovarian Suppression in Premenopausal Women: No Change in Free-Living Energy Expenditure.,"OBJECTIVE
The purpose of this study was to determine whether suppression of ovarian function (gonadotropin-releasing hormone agonist [GnRH AG ]) for 24 weeks in premenopausal women approaching menopause causes changes in body composition and a decline in free-living physical activity energy expenditure (PAEE) and whether endurance exercise training attenuates the changes.
METHODS
Premenopausal women who were approaching menopause (mean [SD]: age 46 [3] years, BMI 26.3 [4.8] kg/m 2 ) were randomized to 24 weeks of GnRH AG (n = 14), GnRH AG + Exercise (n = 11), or placebo (n = 9). Endurance exercise was performed 4 days per week with the goal of expending 200 to 300 kcal per session. Primary outcome measurements included body composition by dual-energy x-ray absorptiometry, total daily energy expenditure (TDEE), and PAEE by doubly labeled water, and resting energy expenditure (REE) by indirect calorimetry.
RESULTS
Changes in TDEE, PAEE, REE, or body composition were not different between groups. However, within the GnRH AG group, fat mass increased (mean [SE]: total 1.7 [0.4] kg, trunk 0.9 [0.2] kg, leg 0.6 [0.2] kg) and fat-free leg mass decreased (mean [SE]: -0.4 [0.2] kg) significantly.
CONCLUSIONS
In premenopausal women approaching menopause, ovarian hormone suppression resulted in increased adiposity without alterations in TDEE, PAEE, or REE.",2020,"RESULTS
Changes in TDEE, PAEE, REE, or body composition were not different between groups.","['premenopausal women approaching menopause', 'Premenopausal women who were approaching menopause (mean [SD]: age 46 [3] years, BMI 26.3 [4.8] kg/m 2 ', 'Premenopausal Women']","['ovarian function (gonadotropin-releasing hormone agonist [GnRH AG ', 'Endurance exercise', 'GnRH AG (n\u2009=\u200914), GnRH AG\u2009 +\u2009Exercise (n\u2009=\u200911), or placebo', 'endurance exercise training']","['fat mass', 'TDEE, PAEE, REE, or body composition', 'body composition by dual-energy x-ray absorptiometry, total daily energy expenditure (TDEE), and PAEE by doubly labeled water, and resting energy expenditure (REE) by indirect calorimetry', 'Free-Living Energy Expenditure', 'fat-free leg mass']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C4517765', 'cui_str': '4.8'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",,0.219336,"RESULTS
Changes in TDEE, PAEE, REE, or body composition were not different between groups.","[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Gavin', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Hildreth', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Gibbons', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Bessesen', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Kohrt', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22978']
1999,33150753,"Long-Term Efficacy of Prophylactic Cavotricuspid Isthmus Ablation during Atrial Fibrillation Ablation in Patients Without Typical Atrial Flutter: a Prospective, Multicentre, Randomized Trial.","BACKGROUND AND OBJECTIVES
Cavotricuspid isthmus (CTI) block is easily achieved, and prophylactic ablation can be performed during atrial fibrillation (AF) ablation. However, the previous study was too small and short-term to clarify the efficacy of this block.
METHODS
Patients who underwent catheter ablation for paroxysmal AF were enrolled, and patients who had previous or induced atrial flutter (AFL) were excluded. We randomly assigned 366 patients to pulmonary vein isolation (PVI) only and prophylactic CTI ablation (PVI vs. PVI+CTI).
RESULTS
There was no significant difference in procedure time between the two groups because most CTI blocks were performed during the waiting time after the PVI (176.8±72.6 minutes in PVI vs. 174.2±76.5 minutes in PVI+CTI, p=0.75). All patients were followed up for at least 18 months, and the median follow-up was 3.4 years. The recurrence rate of AF or AFL was not different in the 2 groups (25.7% in PVI vs. 25.7% in PVI+CTI, p=0.92). The recurrence rate of any AFL was not significantly different in the 2 groups (3.3% in PVI vs. 1.6% in PVI+CTI, p=0.31). The recurrence rate of typical AFL also was not different (0.5% in PVI vs. 0.5% in PVI+CTI, p=0.99).
CONCLUSIONS
In this large and long-term follow-up study, prophylactic CTI ablation had no benefit in patients with paroxysmal AF without typical AFL.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02031705.",2020,There was no significant difference in procedure time between the two groups because most CTI blocks were performed during the waiting time after the PVI (176.8±72.6 minutes in PVI,"['366 patients to', 'patients with paroxysmal AF without typical AFL', 'Patients', 'Patients who underwent catheter ablation for paroxysmal AF were enrolled, and patients who had previous or induced atrial flutter (AFL) were excluded']","['prophylactic CTI ablation', 'Prophylactic Cavotricuspid Isthmus Ablation', 'pulmonary vein isolation (PVI) only and prophylactic CTI ablation (PVI vs. PVI+CTI']","['procedure time', 'recurrence rate of AF or AFL', 'recurrence rate of typical AFL', 'recurrence rate of any AFL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C3264370', 'cui_str': 'Typical atrial flutter'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0229583', 'cui_str': 'Structure of isthmus of thyroid gland'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C3264370', 'cui_str': 'Typical atrial flutter'}]",366.0,0.0438337,There was no significant difference in procedure time between the two groups because most CTI blocks were performed during the waiting time after the PVI (176.8±72.6 minutes in PVI,"[{'ForeName': 'Sung Hwan', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': ""Division of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Yong Seog', 'Initials': 'YS', 'LastName': 'Oh', 'Affiliation': ""Division of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': ""Division of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Youmi', 'Initials': 'Y', 'LastName': 'Hwang', 'Affiliation': ""Division of Cardiology, Department of Internal Medicine, College of Medicine, St. Vincent's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Ju Youn', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': ""Department of Internal Medicine, Division of Cardiology, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Tae Seok', 'Initials': 'TS', 'LastName': 'Kim', 'Affiliation': ""Division of Cardiology, Department of Internal Medicine, College of Medicine, Daejeon St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Ji Hoon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': ""Division of Cardiology, Department of Internal Medicine, College of Medicine, St. Vincent's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Sung Won', 'Initials': 'SW', 'LastName': 'Jang', 'Affiliation': ""Division of Cardiology, Department of Internal Medicine, College of Medicine, Eunpyeong St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Man Young', 'Initials': 'MY', 'LastName': 'Lee', 'Affiliation': ""Division of Cardiology, Department of Internal Medicine, College of Medicine, Yeouido St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Boyoung', 'Initials': 'B', 'LastName': 'Joung', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea. cby6908@yuhs.ac.'}, {'ForeName': 'Kee Joon', 'Initials': 'KJ', 'LastName': 'Choi', 'Affiliation': 'Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. kjchoi@amc.seoul.kr.'}]",Korean circulation journal,['10.4070/kcj.2020.0174']
2000,33150779,Randomization to Omega-3 Fatty Acid Supplementation and Endothelial Function in COPD: The COD-Fish Randomized Controlled Trial.,"Rationale
Studies suggest a pathogenic role of endothelial dysfunction in chronic obstructive lung disease (COPD). Omega-3 (n-3) polyunsaturated fatty acid (PUFA) supplementation improves endothelial function in other diseases but has not been examined in COPD.
Objective
We hypothesized that n-3 PUFA supplementation would improve systemic endothelial function in COPD. We performed a pilot randomized, placebo-controlled, double-blind, phase II superiority trial (NCT00835289).
Methods
Adults with moderate and severe stable COPD (79% with emphysema on CT) were randomized to high-dose fish oil capsules or placebo daily for 6 months. The primary endpoint was percent change in brachial artery flow-mediated dilation (FMD) from baseline to 6 months. Secondary endpoints included peripheral arterial tonometry, endothelial microparticles (EMPs), six-minute walk distance, respiratory symptoms, and pulmonary function.
Results
Thirty-three of forty randomized participants completed all measurements. Change in FMD after 6 months did not differ between the fish oil and placebo arms (-1.1%, 95% CI -5.0-2.9, p=0.59). CD31 + EMPs increased in the fish oil arm (0.9%, 95% CI 0.1-1.7, p=0.04). More participants in the fish oil arm reported at least a 4-point improvement in the St. George's Respiratory Questionnaire (SGRQ) compared to placebo (8 vs. 1; p=0.01). There were no significant changes in other secondary endpoints. There were four serious adverse events determined to be unrelated to the study (3 in the fish oil arm and 1 in the placebo arm).
Conclusion
Randomization to n-3 PUFAs for 6 months did not change systemic endothelial function in COPD. Changes in EMPs and SGRQ suggest n-3 PUFAs might have biologic and clinical effects that warrant further investigation.",2020,"CD31 + EMPs increased in the fish oil arm (0.9%, 95% CI 0.1-1.7, p=0.04).","['Methods\n\n\nAdults with moderate and severe stable COPD (79% with emphysema on CT', 'COPD', 'chronic obstructive lung disease (COPD']","['n-3 PUFAs', 'Omega-3 Fatty Acid Supplementation', 'Omega-3', 'n-3 PUFA supplementation', 'fish oil and placebo', 'placebo', 'oil capsules or placebo', 'n-3) polyunsaturated fatty acid (PUFA) supplementation']","['percent change in brachial artery flow-mediated dilation (FMD', 'systemic endothelial function', 'peripheral arterial tonometry, endothelial microparticles (EMPs), six-minute walk distance, respiratory symptoms, and pulmonary function', 'endothelial function', ""St. George's Respiratory Questionnaire (SGRQ"", 'serious adverse events', 'Change in FMD', 'CD31 + EMPs']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0081939', 'cui_str': 'Lymphocyte antigen CD31'}]",,0.736542,"CD31 + EMPs increased in the fish oil arm (0.9%, 95% CI 0.1-1.7, p=0.04).","[{'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Columbia University Irving Medical Center, New York, New York, United States.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Thomashow', 'Affiliation': 'Department of Medicine, Columbia University Irving Medical Center, New York, New York, United States.'}, {'ForeName': 'Natalie H', 'Initials': 'NH', 'LastName': 'Yip', 'Affiliation': 'Department of Medicine, Columbia University Irving Medical Center, New York, New York, United States.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Burkart', 'Affiliation': 'Department of Medicine, Columbia University Irving Medical Center, New York, New York, United States.'}, {'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Lo Cascio', 'Affiliation': 'Department of Medicine, Columbia University Irving Medical Center, New York, New York, United States.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'Department of Medicine, Columbia University Irving Medical Center, New York, New York, United States.'}, {'ForeName': 'R Graham', 'Initials': 'RG', 'LastName': 'Barr', 'Affiliation': 'Department of Medicine, Columbia University Irving Medical Center, New York, New York, United States.'}]","Chronic obstructive pulmonary diseases (Miami, Fla.)",['10.15326/jcopdf.8.1.2020.0132']
2001,33151151,Personalized Web-Based Weight Loss Behavior Change Program With and Without Dietitian Online Coaching for Adults With Overweight and Obesity: Randomized Controlled Trial.,"BACKGROUND
The effect of computer- or human-delivered personalized feedback on the effectivess of web-based behavior change platforms for weight loss is unclear.
OBJECTIVE
We aimed to compare the effectiveness of a web-based behavior change intervention personalized through either computerized or human-delivered feedback with a nonpersonalized intervention in promoting weight loss in community-based adults with overweight or obesity.
METHODS
This pragmatic, 3-group, parallel-arm, randomized trial recruited students and staff in a Brazilian public university who were aged 18 to 60 years, had a BMI of ≥25 kg/m 2 , and were not pregnant. Participants were allocated to one of 3 groups: platform only (24-week behavior change program delivered using a web platform with personalized computer-delivered feedback), platform plus coaching (same 24-week web-based behavior change program plus 12 weeks of personalized feedback delivered online by a dietitian), or waiting list (nonpersonalized dietary and physical activity recommendations delivered through an e-booklet and videos). Self-reported weight at 24 weeks was the primary outcome. Changes in dietary and physical activity habits within 24 weeks were secondary outcomes.
RESULTS
Among the 1298 participants, 375 (28.89%) were lost to follow-up. In the intention-to-treat analysis, the platform-only and platform plus coaching groups had greater mean weight loss than the waiting-list group at 24 weeks (-1.08 kg, 95% CI -1.41 to -0.75 vs -1.57 kg, 95% CI -1.92 to -1.22 vs -0.66 kg, 95% CI -0.98 to -0.34, respectively). The platform-only and platform plus coaching groups, compared with the waiting list group, had a greater increase in the consumption of vegetables (3%, 95% CI 1% to 6% vs 5%, 95% CI 2% to 8% vs -3%, 95% CI -5% to 0%) and fruits (9%, 95% CI 6% to 12% vs 6%, 95% CI 2% to 9% vs 2%, 95% CI 0% to 6%) and a larger reduction in ultraprocessed food intake (-18%, 95% CI -23% to -13% vs -25%, 95% CI -30% to -20% vs -12%, 95% CI -16% to -8%). Changes in physical activity did not differ across the groups. Engagement was higher in the platform plus coaching group than in the platform-only group (7.6 vs 5.2 completed sessions; P=.007). Longer usage of the platform was associated with clinically meaningful (≥5%) weight loss (odds ratio 1.02, 95% CI 1.01 to 1.04).
CONCLUSIONS
The web-based behavior change programs with computer- and human-delivered personalized feedback led to greater, albeit small-magnitude, weight loss within 24 weeks. Improvement in multiple dietary habits, but not physical activity, were also greater in the personalized programs compared with the nonpersonalized one. The human-delivered personalized feedback by the online dietitian coach increased user engagement with the program and was associated with a significantly higher chance of clinically meaningful weight loss.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03435445; https://clinicaltrials.gov/ct2/show/NCT03435445.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.2196/10.1186/s12889-018-5882-y.",2020,"Longer usage of the platform was associated with clinically meaningful (≥5%) weight loss (odds ratio 1.02, 95% CI 1.01 to 1.04).
","['community-based adults with overweight or obesity', 'Adults With Overweight and Obesity', 'students and staff in a Brazilian public university who were aged 18 to 60 years, had a BMI of ≥25 kg/m 2 , and were not pregnant', '1298 participants, 375 (28.89%) were lost to follow-up']","['platform only (24-week behavior change program delivered using a web platform with personalized computer-delivered feedback), platform plus coaching (same 24-week web-based behavior change program plus 12 weeks of personalized feedback delivered online by a dietitian), or waiting list (nonpersonalized dietary and physical activity recommendations delivered through an e-booklet and videos', 'Dietitian Online Coaching', 'Personalized Web-Based Weight Loss Behavior Change Program', 'computer- or human-delivered personalized feedback', 'web-based behavior change intervention personalized through either computerized or human-delivered feedback with a nonpersonalized intervention']","['weight loss', 'consumption of vegetables', 'mean weight loss', 'dietary and physical activity habits', 'physical activity', 'ultraprocessed food intake']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0013470', 'cui_str': 'Eating'}]",1298.0,0.151828,"Longer usage of the platform was associated with clinically meaningful (≥5%) weight loss (odds ratio 1.02, 95% CI 1.01 to 1.04).
","[{'ForeName': 'Alline', 'Initials': 'A', 'LastName': 'Beleigoli', 'Affiliation': 'Flinders Digital Health Research Centre, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Andre Q', 'Initials': 'AQ', 'LastName': 'Andrade', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Maria De Fatima', 'Initials': 'MF', 'LastName': 'Diniz', 'Affiliation': 'Post Graduation Course of Adult Health Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Antonio Luiz', 'Initials': 'AL', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Internal Medicine, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}]",Journal of medical Internet research,['10.2196/17494']
2002,33151154,"My Diabetes Coach, a Mobile App-Based Interactive Conversational Agent to Support Type 2 Diabetes Self-Management: Randomized Effectiveness-Implementation Trial.","BACKGROUND
Delivering self-management support to people with type 2 diabetes mellitus is essential to reduce the health system burden and to empower people with the skills, knowledge, and confidence needed to take an active role in managing their own health.
OBJECTIVE
This study aims to evaluate the adoption, use, and effectiveness of the My Diabetes Coach (MDC) program, an app-based interactive embodied conversational agent, Laura, designed to support diabetes self-management in the home setting over 12 months.
METHODS
This randomized controlled trial evaluated both the implementation and effectiveness of the MDC program. Adults with type 2 diabetes in Australia were recruited and randomized to the intervention arm (MDC) or the control arm (usual care). Program use was tracked over 12 months. Coprimary outcomes included changes in glycated hemoglobin (HbA 1c ) and health-related quality of life (HRQoL). Data were assessed at baseline and at 6 and 12 months, and analyzed using linear mixed-effects regression models.
RESULTS
A total of 187 adults with type 2 diabetes (mean 57 years, SD 10 years; 41.7% women) were recruited and randomly allocated to the intervention (n=93) and control (n=94) arms. MDC program users (92/93 participants) completed 1942 chats with Laura, averaging 243 min (SD 212) per person over 12 months. Compared with baseline, the mean estimated HbA 1c decreased in both arms at 12 months (intervention: 0.33% and control: 0.20%), but the net differences between the two arms in change of HbA 1c (-0.04%, 95% CI -0.45 to 0.36; P=.83) was not statistically significant. At 12 months, HRQoL utility scores improved in the intervention arm, compared with the control arm (between-arm difference: 0.04, 95% CI 0.00 to 0.07; P=.04).
CONCLUSIONS
The MDC program was successfully adopted and used by individuals with type 2 diabetes and significantly improved the users' HRQoL. These findings suggest the potential for wider implementation of technology-enabled conversation-based programs for supporting diabetes self-management. Future studies should focus on strategies to maintain program usage and HbA 1c improvement.
TRIAL REGISTRATION
Australia New Zealand Clinical Trials Registry (ACTRN) 12614001229662; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614001229662.",2020,"At 12 months, HRQoL utility scores improved in the intervention arm, compared with the control arm (between-arm difference: 0.04, 95% CI 0.00 to 0.07; P=.04).
","['Adults with type 2 diabetes in Australia', '187 adults with type 2 diabetes (mean 57 years, SD 10 years; 41.7% women', 'MDC program users (92/93 participants) completed 1942 chats with Laura, averaging 243 min (SD 212) per person over 12 months', 'people with type 2 diabetes mellitus']","['Mobile App-Based Interactive Conversational Agent', 'Self-Management', 'My Diabetes Coach (MDC) program']","['changes in glycated hemoglobin (HbA 1c ) and health-related quality of life (HRQoL', ""users' HRQoL"", 'HRQoL utility scores', 'mean estimated HbA 1c']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",187.0,0.112503,"At 12 months, HRQoL utility scores improved in the intervention arm, compared with the control arm (between-arm difference: 0.04, 95% CI 0.00 to 0.07; P=.04).
","[{'ForeName': 'Enying', 'Initials': 'E', 'LastName': 'Gong', 'Affiliation': 'School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Shaira', 'Initials': 'S', 'LastName': 'Baptista', 'Affiliation': 'School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Russell', 'Affiliation': 'Princess Alexandra Hospital,, Queensland, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Scuffham', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Queensland, Australia.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Riddell', 'Affiliation': 'Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Speight', 'Affiliation': 'School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Bird', 'Affiliation': 'Centre for Health Services Research, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Williams', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Surrey, United Kingdom.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Lotfaliany', 'Affiliation': 'School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}]",Journal of medical Internet research,['10.2196/20322']
2003,33151187,Accuracy of Dynamic Navigation Surgery in the Placement of Pterygoid Implants.,"Pterygoid implant placement has not been a common treatment modality to manage the atrophic posterior maxilla. This randomized, controlled clinical trial evaluated the accuracy of dynamic navigation using trace registration (TR) technology in pterygoid implant placement when compared to free-hand surgery. Partially edentulous patients requiring at least one pterygoid implant to rehabilitate the atrophic posterior maxilla were included. Implant accuracy (in a prosthetically directed context) and the relation of the placed implants to the greater palatine canal (GPC) were evaluated using EvaluNav to compare the preoperative CBCT plan with the postoperative CBCT implant location. Osseointegration success, mucosal thickness, implant length, time spent for surgical placement, and ease of prosthetic restorability via degree of multi-unit abutment angulation were assessed. A total of 63 pterygoid implants were placed (31 using TR, 32 using free-hand) in 39 partially edentulous patients. Mean deviations between the planned and actual position for TR-placed implants were 0.66 mm at the coronal level, 1.13 mm at the apical level, 0.67 mm in depth, and 2.64 degrees of angular deviation, compared to 1.54 mm, 2.73 mm, 1.17 mm, and 12.49 degrees, respectively, for free-hand implants. In relation to the GPC, TR implants were more accurate when compared to the presurgical plan and took less surgical time. The mean mucosal thickness measured for all implants was 5.41 mm. Most implants were 15 to 18 mm long, and most prostheses (92%) could be accommodated by a 17- or 30-degree multi-unit screw-retained abutment. TR implants had greater short-term osseointegration success rates than free-hand implants (100% vs 93.75%). Pterygoid implant surgery can be a predictable and successful modality for prosthetically directed implant rehabilitation in the atrophic posterior maxilla, is more accurate than free-hand surgery, and takes less time when using dynamic navigation via TR.",2020,"In relation to the GPC, TR implants were more accurate when compared to the presurgical plan and took less surgical time.","['Partially edentulous patients requiring at least one pterygoid implant to rehabilitate the atrophic posterior maxilla were included', '39 partially edentulous patients']","['Pterygoid implant placement', 'Dynamic Navigation Surgery', 'Pterygoid implant surgery', 'dynamic navigation using trace registration (TR) technology']","['Osseointegration success, mucosal thickness, implant length, time spent for surgical placement, and ease of prosthetic restorability via degree of multi-unit abutment angulation', 'mean mucosal thickness', 'short-term osseointegration success rates', 'Implant accuracy', 'Mean deviations']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0079949', 'cui_str': 'Osseointegration'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1828170', 'cui_str': 'Mean deviation'}]",,0.093389,"In relation to the GPC, TR implants were more accurate when compared to the presurgical plan and took less surgical time.","[{'ForeName': 'Luigi V', 'Initials': 'LV', 'LastName': 'Stefanelli', 'Affiliation': ''}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Graziani', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Pranno', 'Affiliation': ''}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Di Carlo', 'Affiliation': ''}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Mandelaris', 'Affiliation': ''}]",The International journal of periodontics & restorative dentistry,['10.11607/prd.4605']
2004,33151266,"Efficacy of Circulating Tumor Cell Count-Driven vs Clinician-Driven First-line Therapy Choice in Hormone Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer: The STIC CTC Randomized Clinical Trial.","Importance
The choice between chemotherapy and endocrine therapy as first-line treatment for hormone receptor-positive, ERBB2 (also known as HER2)-negative metastatic breast cancer is usually based on the presence of clinical features associated with a poor prognosis. In this setting, a high circulating tumor cell (CTC) count (≥5 CTCs/7.5 mL) is a strong adverse prognostic factor for overall survival and progression-free survival (PFS).
Objective
To compare the efficacy of a clinician-driven treatment choice vs a CTC-driven choice for first-line treatment.
Interventions
In the CTC arm, patients received chemotherapy or endocrine therapy according to the CTC count (chemotherapy if ≥5 CTCs/7.5 mL; endocrine therapy if <5 CTCs/7.5 mL), whereas in the control arm, the choice was left to the investigator.
Design, Setting, and Participants
In the STIC CTC randomized, open-label, noninferiority phase 3 trial, participants were randomized to a clinician-driven choice of first-line treatment or a CTC count-driven first-line treatment choice. Eligible participants were premenopausal and postmenopausal women 18 years or older diagnosed with hormone receptor-positive, ERBB2-negative metastatic breast cancer. Data were collected at 17 French cancer centers from February 1, 2012, to July 28, 2016, and analyzed June 2019 to October 2019.
Main Outcome and Measures
The primary end point was the investigator-assessed PFS in the per-protocol population, with a noninferiority margin of 1.25 for the 90% CI of the hazard ratio.
Results
Among the 755 women in the per-protocol population, the median (range) age was 63 (30-88) years [64 (30-88) years for the 377 patients allocated to the CTC arm and 63 (31-87) years for the 378 patients allocated to the standard arm]; 138 (37%) and 103 (27%) received chemotherapy, respectively. Median PFS was 15.5 months (95% CI, 12.7-17.3) in the CTC arm and 13.9 months (95% CI, 12.2-16.3) in the standard arm. The primary end point was met, with a hazard ratio of 0.94 (90% CI, 0.81-1.09).
Conclusions and Relevance
This randomized clinical trial found that the CTC count may be a reliable biomarker method for guiding the choice between chemotherapy and endocrine therapy as the first-line treatment in hormone receptor-positive, ERBB2-negative metastatic breast cancer.
Trial Registration
ClinicalTrials.gov Identifier: NCT01710605.",2020,"The primary end point was met, with a hazard ratio of 0.94 (90% CI, 0.81-1.09).
","['Eligible participants were premenopausal and postmenopausal women 18 years or older diagnosed with hormone receptor-positive, ERBB2-negative metastatic breast cancer', 'Hormone Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer', '17 French cancer centers from February 1, 2012, to July 28, 2016, and analyzed June 2019 to October 2019', '755 women in the per-protocol population, the median (range) age was 63 (30-88) years [64 (30-88) years for the 377 patients allocated to the CTC arm and 63 (31-87) years for the 378 patients allocated to the standard arm]; 138 (37%) and 103 (27%) received']","['chemotherapy and endocrine therapy', 'Circulating Tumor Cell Count-Driven vs Clinician-Driven First-line Therapy Choice', 'clinician-driven choice of first-line treatment or a CTC count-driven first-line treatment choice', 'chemotherapy or endocrine therapy', 'chemotherapy']","['investigator-assessed PFS', 'Median PFS']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517526', 'cui_str': '103'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0927096,"The primary end point was met, with a hazard ratio of 0.94 (90% CI, 0.81-1.09).
","[{'ForeName': 'François-Clément', 'Initials': 'FC', 'LastName': 'Bidard', 'Affiliation': 'Department of Medical Oncology, Institut Curie, UVSQ and Paris-Saclay University, Saint-Cloud, France.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Jacot', 'Affiliation': 'Department of Medical Oncology, Institut du Cancer de Montpellier (ICM), Institut de Recherche en Cancérologie de Montpellier, INSERM U1194, Montpellier University, Montpellier, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Kiavue', 'Affiliation': 'Department of Medical Oncology, Institut Curie, UVSQ and Paris-Saclay University, Saint-Cloud, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Dureau', 'Affiliation': 'Biometry Unit, Institut Curie, PSL Research University, Paris, France.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Kadi', 'Affiliation': 'Biometry Unit, Institut Curie, PSL Research University, Paris, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Brain', 'Affiliation': 'Department of Medical Oncology, Institut Curie, UVSQ and Paris-Saclay University, Saint-Cloud, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bachelot', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Bourgeois', 'Affiliation': 'Department of Medical Oncology, Victor Hugo Clinic, Le Mans, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes, CRCM, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Ladoire', 'Affiliation': 'Department of Medical Oncology, Centre Georges François Leclerc, Dijon, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Naman', 'Affiliation': 'Department of Medical Oncology, Centre Azuréen de Cancérologie, Mougins, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Dalenc', 'Affiliation': 'Department of Medical Oncology, Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Gligorov', 'Affiliation': 'Department of Medical Oncology, Hôpital Tenon, Sorbonne Université, Paris, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Espié', 'Affiliation': 'Department of Medical Oncology, Hôpital Saint-Louis, Paris, France.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Emile', 'Affiliation': 'Department of Medical Oncology, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Ferrero', 'Affiliation': 'Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Loirat', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Université de Paris, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Frank', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Université de Paris, Paris, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Cabel', 'Affiliation': 'Department of Medical Oncology, Institut Curie, UVSQ and Paris-Saclay University, Saint-Cloud, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Formerly with Department of Medical Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Cayrefourcq', 'Affiliation': 'Laboratory of Rare Human Circulating Cells, University Medical Center of Montpellier, EA 2415, Montpellier University, Montpellier, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Simondi', 'Affiliation': 'Clinical Research Department, Institut Curie, PSL Research University, Paris, France.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Berger', 'Affiliation': 'Biometry Unit, Institut Curie, PSL Research University, Paris, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Alix-Panabières', 'Affiliation': 'Laboratory of Rare Human Circulating Cells, University Medical Center of Montpellier, EA 2415, Montpellier University, Montpellier, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Pierga', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Université de Paris, Paris, France.'}]",JAMA oncology,['10.1001/jamaoncol.2020.5660']
2005,33148766,Mindfulness-based cognitive therapy experiences in youth with inflammatory bowel disease and depression: findings from a mixed methods qualitative study.,"OBJECTIVES
Mindfulness-based cognitive therapy (MBCT) is effective in treating psychosocial comorbidities in inflammatory bowel disease (IBD); however, there have been no qualitative studies of MBCT experiences among youth with IBD. We aimed to examine the experiences of youth with IBD and depression who completed an adapted MBCT group programme, and the impact of common psychotherapy and group factors.
DESIGN
This mixed method qualitative study, nested within a randomised controlled trial (RCT) of MBCT for youth with IBD, employed thematic analysis of qualitative data from three focus groups and open-ended survey questions.
SETTING
The study was conducted in the outpatient department of a tertiary hospital for young adults in Brisbane, Australia.
PARTICIPANTS
Out of sixty-four adolescents and young adults recruited to the RCT of MBCT for youth with IBD and depression, 29 completed the MBCT evaluation survey and 19 attended the focus groups.
RESULTS
Four key themes emerged: 'connectedness and shared understanding', 'growing in wisdom', 'therapeutic alliance' and 'barriers to mindfulness practice'. Participants described MBCT experiences as healing and transformative with the themes of connectedness, growing in wisdom and therapeutic alliance laying the foundation for therapeutic change. Main barriers included fatigue, depression, time and travel constraints.
CONCLUSIONS
The study identified key themes facilitating the process of therapeutic change within the MBCT programme for youth with IBD and elucidated common and group psychotherapy factors underlying the key themes. Participants perceived connecting with peers as essential for learning mindfulness skills which in turn strengthened the connection. Study findings will facilitate interpretation of the results of the RCT of MBCT in youth with IBD and inform the design of future studies of MBCT in this cohort.
TRIAL REGISTRATION NUMBER
ACTRN12617000876392; Results.",2020,"RESULTS
Four key themes emerged: 'connectedness and shared understanding', 'growing in wisdom', 'therapeutic alliance' and 'barriers to mindfulness practice'.","['outpatient department of a tertiary hospital for young adults in Brisbane, Australia', 'inflammatory bowel disease (IBD', 'youth with IBD', 'youth with inflammatory bowel disease and depression', 'Out of sixty-four adolescents and young adults recruited to the RCT of MBCT for youth with IBD and depression, 29 completed the MBCT evaluation survey and 19 attended the focus groups']","['MBCT', 'Mindfulness-based cognitive therapy experiences', 'Mindfulness-based cognitive therapy (MBCT']","[""connectedness and shared understanding', 'growing in wisdom', 'therapeutic alliance' and 'barriers to mindfulness practice"", 'fatigue, depression, time and travel constraints']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",64.0,0.058211,"RESULTS
Four key themes emerged: 'connectedness and shared understanding', 'growing in wisdom', 'therapeutic alliance' and 'barriers to mindfulness practice'.","[{'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Ewais', 'Affiliation': 'Mater Clinical School and Princess Alexandra Clinical School, School of Medicine, University of Queensland, Saint Lucia, Queensland, Australia tatjanaewais@gmail.com.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Begun', 'Affiliation': 'Mater Clinical School and Princess Alexandra Clinical School, School of Medicine, University of Queensland, Saint Lucia, Queensland, Australia.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Kenny', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Headey', 'Affiliation': 'Mater Young Adult Health Centre, Mater Misericordiae Ltd, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Merilyn', 'Initials': 'M', 'LastName': 'Tefay', 'Affiliation': 'Mater Young Adult Health Centre, Mater Misericordiae Ltd, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Kisely', 'Affiliation': 'Mater Clinical School and Princess Alexandra Clinical School, School of Medicine, University of Queensland, Saint Lucia, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-041140']
2006,33148767,Exercise for people living with frailty and receiving haemodialysis: a mixed-methods randomised controlled feasibility study.,"OBJECTIVES
Frailty is highly prevalent in haemodialysis (HD) patients, leading to poor outcomes. This study aimed to determine whether a randomised controlled trial (RCT) of intradialytic exercise is feasible for frail HD patients, and explore how the intervention may be tailored to their needs.
DESIGN
Mixed-methods feasibility.
SETTING AND PARTICIPANTS
Prevalent adult HD patients of the CYCLE-HD trial with a Clinical Frailty Scale Score of 4-7 (vulnerable to severely frail) were eligible for the feasibility study.
INTERVENTIONS
Participants in the exercise group undertook 6 months of three times per week, progressive, moderate intensity intradialytic cycling (IDC).
OUTCOMES
Primary outcomes were related to feasibility. Secondary outcomes were falls incidence measured from baseline to 1 year following intervention completion, and exercise capacity, physical function, physical activity and patient-reported outcomes measured at baseline and 6 months. Acceptability of trial procedures and the intervention were explored via diaries and interviews with n=25 frail HD patients who both participated in (n=13, 52%), and declined (n=12, 48%), the trial.
RESULTS
124 (30%) patients were eligible, and of these 64 (52%) consented with 51 (80%) subsequently completing a baseline assessment. n=24 (71% male; 59±13 years) dialysed during shifts randomly assigned to exercise and n=27 (81% male; 65±11 years) shifts assigned to usual care. n=6 (12%) were lost to follow-up. The exercise group completed 74% of sessions. 27%-89% of secondary outcome data were missing. Frail HD patients outlined several ways to enhance trial procedures. Maintaining ability to undertake activities of daily living and social participation were outcomes of primary importance. Participants desired a varied exercise programme.
CONCLUSIONS
A definitive RCT is feasible, however a comprehensive exercise programme may be more efficacious than IDC in this population.
TRIAL REGISTRATION NUMBERS
ISRCTN11299707; ISRCTN12840463.",2020,"Acceptability of trial procedures and the intervention were explored via diaries and interviews with n=25 frail HD patients who both participated in (n=13, 52%), and declined (n=12, 48%), the trial.
","['frail HD patients', 'n=24 (71% male; 59±13 years) dialysed during shifts randomly assigned to exercise and n=27 ', 'people living with frailty and receiving haemodialysis', '124 (30', 'Frail HD patients', 'haemodialysis (HD) patients', 'Prevalent adult HD patients of the CYCLE-HD trial with a Clinical Frailty Scale Score of 4-7 (vulnerable to severely frail', 'n=25 frail HD patients who both participated in (n=13, 52%), and declined (n=12, 48%), the trial', 'patients were eligible, and of these 64 (52%) consented with 51 (80%) subsequently completing a baseline assessment']","['intradialytic exercise', 'Exercise']","['falls incidence measured from baseline to 1 year following intervention completion, and exercise capacity, physical function, physical activity and patient-reported outcomes', 'progressive, moderate intensity intradialytic cycling (IDC']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]",25.0,0.129182,"Acceptability of trial procedures and the intervention were explored via diaries and interviews with n=25 frail HD patients who both participated in (n=13, 52%), and declined (n=12, 48%), the trial.
","[{'ForeName': 'Hannah M L', 'Initials': 'HML', 'LastName': 'Young', 'Affiliation': 'Department of Respiratory Sciences, University of Leicester, Leicester, UK hmly1@le.ac.uk.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'March', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Highton', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Matthew P M', 'Initials': 'MPM', 'LastName': 'Graham-Brown', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Darren C', 'Initials': 'DC', 'LastName': 'Churchward', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Grantham', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Goodliffe', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Jones', 'Affiliation': 'Emergency Department, Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Mei-Mei', 'Initials': 'MM', 'LastName': 'Cheung', 'Affiliation': 'Renal, Respiratory and Cardiovascular Clinical Management Group, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Sharlene A', 'Initials': 'SA', 'LastName': 'Greenwood', 'Affiliation': ""Department of Physiotherapy and Renal Medicine, King's College Hospital, London, UK.""}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Eborall', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Conroy', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Singh', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, Leicester Biomedical Research Unit, Leicester, UK.'}, {'ForeName': 'Alice C', 'Initials': 'AC', 'LastName': 'Smith', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Burton', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}]",BMJ open,['10.1136/bmjopen-2020-041227']
2007,33148771,Group Sessions or Home Visits for Early Childhood Development in India: A Cluster RCT.,"OBJECTIVES
Poor early childhood development in low- and middle-income countries is a major public health problem. Efficacy trials have shown the potential of early childhood development interventions but scaling up is costly and challenging. Guidance on effective interventions' delivery is needed. In an open-label cluster-randomized control trial, we compared the effectiveness of weekly home visits and weekly mother-child group sessions. Both included nutritional education, whose effectiveness was tested separately.
METHODS
In Odisha, India, 192 villages were randomly assigned to control, nutritional education, nutritional education and home visiting, or nutritional education and group sessions. Mothers with children aged 7 to 16 months were enrolled ( n = 1449). Trained local women ran the two-year interventions, which comprised demonstrations and interactions and targeted improved play and nutrition. Primary outcomes, measured at baseline, midline (12 months), and endline (24 months), were child cognition, language, motor development, growth and morbidity.
RESULTS
Home visiting and group sessions had similar positive average (intention-to-treat) impacts on cognition (home visiting: 0.324 SD, 95% confidence interval [CI]: 0.152 to 0.496, P = .001; group sessions: 0.281 SD, 95% CI: 0.100 to 0.463, P = .007) and language (home visiting: 0.239 SD, 95% CI: 0.072 to 0.407, P = .009; group sessions: 0.302 SD, 95% CI: 0.136 to 0.468, P = .001). Most benefits occurred in the first year. Nutrition-education had no benefit. There were no consistent effects on any other primary outcomes.
CONCLUSIONS
Group sessions cost $38 per child per year and were as effective on average as home visiting, which cost $135, implying an increase by a factor of 3.5 in the returns to investment with group sessions, offering a more scalable model. Impacts materialize in the first year, having important design implications.",2020,"There were no consistent effects on any other primary outcomes.
","['In Odisha, India, 192 villages', 'India', 'Mothers with children aged 7 to 16 months were enrolled ( n = 1449']","['control, nutritional education, nutritional education and home visiting, or nutritional education and group sessions', 'weekly home visits and weekly mother-child group sessions']","['child cognition, language, motor development, growth and morbidity', 'similar positive average (intention-to-treat) impacts on cognition']","[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",192.0,0.0780143,"There were no consistent effects on any other primary outcomes.
","[{'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Grantham-McGregor', 'Affiliation': 'Institute for Global Health, University College London, London, England; sallymcgregor@yahoo.com.'}, {'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Adya', 'Affiliation': 'Department of Anthropology, Psychology and Sociology, University of West Georgia, Carrollton, Georgia.'}, {'ForeName': 'Orazio', 'Initials': 'O', 'LastName': 'Attanasio', 'Affiliation': 'Department of Economics, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Augsburg', 'Affiliation': 'Institute for Fiscal Studies, London, United Kingdom.'}, {'ForeName': 'Jere', 'Initials': 'J', 'LastName': 'Behrman', 'Affiliation': 'Department of Economics and Sociology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Bet', 'Initials': 'B', 'LastName': 'Caeyers', 'Affiliation': 'Institute for Fiscal Studies, London, United Kingdom.'}, {'ForeName': 'Monimalika', 'Initials': 'M', 'LastName': 'Day', 'Affiliation': 'Centre for Early Childhood Education and Development at Ambedkar University, Delhi, India.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Jervis', 'Affiliation': 'Institute for Fiscal Studies, London, United Kingdom.'}, {'ForeName': 'Reema', 'Initials': 'R', 'LastName': 'Kochar', 'Affiliation': 'Centre for Early Childhood Education and Development at Ambedkar University, Delhi, India.'}, {'ForeName': 'Prerna', 'Initials': 'P', 'LastName': 'Makkar', 'Affiliation': 'Pratham Education Foundation, India; and.'}, {'ForeName': 'Costas', 'Initials': 'C', 'LastName': 'Meghir', 'Affiliation': 'Department of Economics, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'Phimister', 'Affiliation': 'Institute for Fiscal Studies, London, United Kingdom.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Rubio-Codina', 'Affiliation': 'Inter-American Development Bank, Washington, DC.'}, {'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Vats', 'Affiliation': 'Pratham Education Foundation, India; and.'}]",Pediatrics,['10.1542/peds.2020-002725']
2008,33148839,EFFECTIVENESS OF PHYSICAL THERAPY IN MYOFASCIAL SYNDROME IN PATIENTS WITH MULTIPLE SCLEROSIS.,"OBJECTIVE
The aim: Is to conduct a comparative analysis of electroneuromyographic parameters in patients with myofascial pain syndrome with multiple sclerosis under the conditions of using various means of physical therapy.
PATIENTS AND METHODS
Materials and methods: 105 patients aged 21 to 54 years were examined with MPS in MS. Neurological disorders were verified according to ENMG examinations. 64 patients were enrolled in an experimental group for which a specially designed program was included, which included reflexology and exercise for stretching muscles for 30 days. The control group included 41 patients who underwent a FT course based on therapeutic massage during the same time. Analysis of global ENMG was performed according to functional tests («muscle relaxation» and «maximum arbitrary muscle tension» with m. Tibialis anterior and m. Rectus femoris), M-responses and H-reflexes, polysynaptic responses (PSV) in withdrawal from these muscles during short-term stimulation n. plantaris (number of pulses in series 10, frequency - 20 Hz, duration of a separate stimulation signal - 1 ms, intensity - double threshold of contractile response of the muscles of the sole of the foot) and residual latency as the time of motor impulse on terminal non-myelinated nerve. Testing was performed on the same muscle groups on the left and righ.
RESULTS
Results: Before physical therapy during electromyographic testing, a significant decrease in the amplitude of the maximum M response, a decrease in the speed of the impulse in the proximal and distal segments of the peripheral nerve, was found to be significant compared with the control, the ratio of the proximal-distal coefficient and the residual latency index significantly increased, which indicates a demyelinating character lesions of nerve conductors. After reflexotherapy with muscle stretching in 38.0% of the patients of the experimental group, the dynamics of the amplitude of the M-answers on the left and on the right has only a tendency to further increase, while in the other 62.0% of patients, the amplitude of the M-responses increases bilaterally and is 65.7% higher than in the control group.
CONCLUSION
Conclusions: The use of reflexology in conjunction with stretching leads to a reduction in muscle spasticity and pain, as evidenced by electrophysiological indicators that substantiate their feasibility in the practice of physical therapy to improve the functional status of patients with MPS in MS.",2020,"Before physical therapy during electromyographic testing, a significant decrease in the amplitude of the maximum M response, a decrease in the speed of the impulse in the proximal and distal segments of the peripheral nerve, was found to be significant compared with the control, the ratio of the proximal-distal coefficient and the residual latency index significantly increased, which indicates a demyelinating character lesions of nerve conductors.","['41 patients who underwent a FT course based on therapeutic massage during the same time', 'patients with MPS in MS', 'Materials and methods', 'patients with myofascial pain syndrome with multiple sclerosis under the conditions of using various means of physical therapy', '105 patients aged 21 to 54 years', '64 patients were enrolled in an experimental group for which a specially designed program was included, which included reflexology and exercise for stretching muscles for 30 days']","['OF PHYSICAL THERAPY', 'reflexotherapy', 'MPS']","['residual latency index', 'speed of the impulse in the proximal and distal segments of the peripheral nerve', 'amplitude of the maximum M response', 'Rectus femoris), M-responses and H-reflexes, polysynaptic responses (PSV', 'Neurological disorders']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0407178', 'cui_str': 'Stretching of muscle'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0034946', 'cui_str': 'Reflex Therapy'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0018447', 'cui_str': 'H-reflex'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}]",105.0,0.0134816,"Before physical therapy during electromyographic testing, a significant decrease in the amplitude of the maximum M response, a decrease in the speed of the impulse in the proximal and distal segments of the peripheral nerve, was found to be significant compared with the control, the ratio of the proximal-distal coefficient and the residual latency index significantly increased, which indicates a demyelinating character lesions of nerve conductors.","[{'ForeName': 'Zinovyi M', 'Initials': 'ZM', 'LastName': 'Оstаpyak', 'Affiliation': 'VASYL STEFANYK PRECARPATHIAN NATIONAL UNIVERSITY, IVANO-FRANKIVSK, UKRAINE.'}, {'ForeName': 'Bogdan M', 'Initials': 'BM', 'LastName': 'Mytckan', 'Affiliation': 'VASYL STEFANYK PRECARPATHIAN NATIONAL UNIVERSITY, IVANO-FRANKIVSK, UKRAINE.'}, {'ForeName': 'Przemyslaw', 'Initials': 'P', 'LastName': 'Bejga', 'Affiliation': 'UNIVERSITY OF ZIELONA GÓRA, ZIELONA GÓRA, POLAND.'}, {'ForeName': 'Roman P', 'Initials': 'RP', 'LastName': 'Gerich', 'Affiliation': 'VASYL STEFANYK PRECARPATHIAN NATIONAL UNIVERSITY, IVANO-FRANKIVSK, UKRAINE.'}, {'ForeName': 'Serg L', 'Initials': 'SL', 'LastName': ""Popel'"", 'Affiliation': 'VASYL STEFANYK PRECARPATHIAN NATIONAL UNIVERSITY, IVANO-FRANKIVSK, UKRAINE.'}]","Wiadomosci lekarskie (Warsaw, Poland : 1960)",[]
2009,33148990,Evaluating the Benefits of Exercise Training in HFrEF or COPD Patients: ISO-LEVEL COMPARISON CAN ADD VALUABLE INFORMATION TO V˙o2peak.,"BACKGROUND
Heart failure with reduced ejection fraction (HFrEF) and chronic obstructive pulmonary disease (COPD) are relatively common conditions with similar symptoms of exercise intolerance and dyspnea. The aim of this study was to compare exercise capacity, ventilatory response, and breathing pattern in patient groups with either advanced HFrEF or COPD before and after exercise training.
METHODS
An observational study was conducted with parallel groups of 25 HFrEF and 25 COPD patients who took part in 6 wk of inpatient rehabilitation with exercise training. All patients underwent cardiopulmonary exercise tests at the start and end of the training, with resting arterial blood gas measurements.
RESULTS
The average peak oxygen uptake (V˙o2) was low at the start of the study but increased significantly after training in both groups, or by 2.2 ± 2.1 mL/kg/min in HFrEF patients and 1.2 ± 2.2 mL/kg/min in COPD patients. At ISO-V˙o2 (ie, same level of V˙o2 in pre- and post-exercise tests), carbon dioxide production (V˙co2) decreased after exercise training in both groups. Similarly, at ISO-V˙E (ie, same level of ventilation), breathing frequency (f) decreased and tidal volume (VT) increased, resulting in an improved breathing pattern (lower f/VT ratio) after training.
CONCLUSION
The findings of this study show that exercise training in severely affected patient groups with HFrEF or COPD led to an increase in maximal exercise capacity, a more favorable breathing pattern, and a diminished V˙co2 during exercise. Therefore, comparisons of V˙co2 and breathing pattern at ISO-levels of V˙o2 or V˙E before and after training are valuable and underutilized outcome measures in treatment studies.",2020,"The average peak oxygen uptake (V˙o2) was low at the start of the study but increased significantly after training in both groups, or by 2.2 ± 2.1 mL/kg/min in HFrEF patients and 1.2 ± 2.2 mL/kg/min in COPD patients.","['parallel groups of 25 HFrEF and 25 COPD patients who took part in 6 wk of inpatient rehabilitation with exercise training', 'HFrEF or COPD Patients', 'patient groups with either advanced HFrEF or COPD before and after exercise training']","['exercise training', 'Exercise Training']","['maximal exercise capacity', 'exercise capacity, ventilatory response, and breathing pattern', 'improved breathing pattern', 'average peak oxygen uptake (V˙o2', 'carbon dioxide production (V˙co2', 'ISO-V˙E (ie, same level of ventilation), breathing frequency (f) decreased and tidal volume (VT']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}]",25.0,0.0285144,"The average peak oxygen uptake (V˙o2) was low at the start of the study but increased significantly after training in both groups, or by 2.2 ± 2.1 mL/kg/min in HFrEF patients and 1.2 ± 2.2 mL/kg/min in COPD patients.","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Gudjonsdottir', 'Affiliation': 'Department of Physiology, University of Iceland, Reykjavík, Iceland (Dr Gudjonsdottir and Ms Thoroddsen); Cardiopulmonary Laboratory (Dr Gudjonsdottir and Ms Karlsdottir), Department of Pulmonary Rehabilitation (Ms Kristjansdottir and Dr Asgeirsdottir), and Department of Cardiac Rehabilitation (Drs Jonasson and Kristjansson), Reykjalundur Rehabilitation Centre, Reykjavík, Iceland; MS Iceland Dairies, Akureyri, Iceland (Ms Thoroddsen); and School of Health Sciences, University of Akureyri, Akureyri, Iceland (Dr Sigurdsson).'}, {'ForeName': 'Egill', 'Initials': 'E', 'LastName': 'Thoroddsen', 'Affiliation': ''}, {'ForeName': 'Arna E', 'Initials': 'AE', 'LastName': 'Karlsdottir', 'Affiliation': ''}, {'ForeName': 'Asdis', 'Initials': 'A', 'LastName': 'Kristjansdottir', 'Affiliation': ''}, {'ForeName': 'Magnus R', 'Initials': 'MR', 'LastName': 'Jonasson', 'Affiliation': ''}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Asgeirsdottir', 'Affiliation': ''}, {'ForeName': 'Stefan B', 'Initials': 'SB', 'LastName': 'Sigurdsson', 'Affiliation': ''}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Kristjansson', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000528']
2010,33149022,Randomized Pilot Trial of Percutaneous Posterior Tibial Nerve Stimulation Versus Medical Therapy for the Treatment of Low Anterior Resection Syndrome: One-Year Follow-up.,"BACKGROUND
Low anterior resection syndrome is significantly associated with a deterioration in the quality of life, and its medical treatment is usually ineffective.
OBJECTIVE
The aim of the present study was to establish the efficacy of percutaneous tibial nerve stimulation in treating this syndrome.
DESIGN
This is a randomized pilot trial with 1-year follow-up.
SETTINGS
The study was conducted in a specialized colorectal unit of a tertiary hospital.
PATIENTS
Patients who underwent neoadjuvant chemoradiotherapy and low anterior rectal resection for cancer with low anterior resection syndrome score ≥21 and ileostomy closed at least 18 months earlier were included.
INTERVENTIONS
Patients were randomly assigned to receive either percutaneous tibial nerve stimulation plus medical treatment (arm A, n = 6) or medical treatment (arm B, n = 6). Low anterior resection syndrome was assessed using symptom severity and disease-specific quality-of-life scores at baseline, at the end of treatment, and at 1-year follow-up.
MAIN OUTCOME MEASURES
The primary outcome was a clinical response, defined as a reduction of the low anterior resection syndrome score.
RESULTS
Only in group A low anterior resection syndrome score, fecal incontinence severity index, and obstructed defecation syndrome score improved significantly with treatment (35.8 ± 2.5 vs 29.0 ± 3.8 (p = 0.03); 36.8 ± 4.3 vs 18.5 ± 8.0 (p = 0.02); 10.3 ± 3.9 vs 8.0 ± 4.9 (p = 0.009)) and changes were observed in all domains of quality-of-life instruments. In both groups the symptom severity and quality-of-life scores at 1-year follow-up did not differ significantly from those recorded at the end of treatment.
LIMITATIONS
The study had a small number of patients and it was underpowered to detect the within-group effect.
CONCLUSIONS
Percutaneous tibial nerve stimulation could be an effective treatment for low anterior resection syndrome. Additional studies are warranted to investigate clinical effectiveness in low anterior resection syndrome. See Video Abstract at http://links.lww.com/DCR/B371. ESTUDIO PILOTO ALEATORIO DE ESTIMULACIÓN PERCUTÁNEA DEL NERVIO TIBIAL POSTERIOR VERSUS TERAPIA MÉDICA PARA EL TRATAMIENTO DEL SÍNDROME DE RESECCIÓN ANTERIOR BAJA: UN AÑO DE SEGUIMIENTO: El síndrome de resección anterior baja se asocia con un deterioro significativo en la calidad de vida y su tratamiento médico generalmente es ineficaz.El objetivo del presente estudio fue establecer la eficacia de la estimulación percutánea del nervio tibial en el tratamiento de este síndrome.Este es un estudio piloto aleatorio con 1 año de seguimiento.El estudio se realizó en una unidad colorrectal especializada de un hospital terciario.Se incluyeron pacientes que se sometieron a quimiorradioterapia neoadyuvante y resección rectal anterior baja por cáncer con puntaje de síndrome de resección anterior baja ≥ 21 e ileostomía cerrada al menos 18 meses antes.Los pacientes fueron asignados aleatoriamente para recibir estimulación percutánea del nervio tibial + tratamiento médico (brazo A, n = 6) o tratamiento médico (brazo B, n = 6). El síndrome de resección anterior baja se evaluó utilizando puntajes de la gravedad de los síntomas y de calidad de vida específicos de la enfermedad al inicio, al final del tratamiento y al año de seguimiento.El resultado primario fue una respuesta clínica, definida como una reducción de la puntuación del síndrome de resección anterior baja.Solo en el grupo A, el puntaje del síndrome de resección anterior baja, el índice de severidad de incontinencia fecal y el puntaje del síndrome de defecación obstruida mejoraron significativamente con el tratamiento (35.8 ± 2.5 vs 29 ± 3.8, p = 0.03; 36.8 ± 4.3 vs 18.5 ± 8.0, p = 0.02; 10.3 ± 3.9 vs 8.0 ± 4.9, p = 0.009, respectivamente) y se observaron cambios en todos los dominios de los instrumentos de calidad de vida. En ambos grupos, los puntajes de severidad de los síntomas y de calidad de vida al año de seguimiento no difirieron significativamente de los registrados al final del tratamiento.El estudio tuvo un pequeño número de pacientes y no logró suficiente poder para detectar el efecto dentro de grupo.La estimulación percutánea del nervio tibial podría ser un tratamiento efectivo para el síndrome de resección anterior baja. Se requieren estudios adicionales para investigar la efectividad clínica en el síndrome de resección anterior baja. Consulte Video Resumen http://links.lww.com/DCR/B371.",2020,"In both groups the symptom severity and quality-of-life scores at 1-year follow-up did not differ significantly from those recorded at the end of treatment.
","['Low Anterior Resection Syndrome', 'specialized colorectal unit of a tertiary hospital', 'for cancer with low anterior resection syndrome score ≥21 and ileostomy closed at least 18 months earlier were included', 'Patients who underwent']","['Percutaneous Posterior Tibial Nerve Stimulation Versus Medical Therapy', 'neoadjuvant chemoradiotherapy and low anterior rectal resection', 'Percutaneous tibial nerve stimulation', 'quimiorradioterapia neoadyuvante y resección rectal anterior baja', 'El estudio tuvo un pequeño número', 'Solo en', 'percutaneous tibial nerve stimulation plus medical treatment (arm A, n = 6) or medical treatment', 'percutaneous tibial nerve stimulation']","['El objetivo', 'de incontinencia fecal', 'symptom severity and quality-of-life scores', 'low anterior resection syndrome score, fecal incontinence severity index, and obstructed defecation syndrome score', 'clinical response, defined as a reduction of the low anterior resection syndrome score', 'Low anterior resection syndrome', 'symptom severity and disease-specific quality-of-life scores']","[{'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior'}, {'cui': 'C0193062', 'cui_str': 'Resection of rectum'}, {'cui': 'C3805249', 'cui_str': 'Percutaneous tibial nerve stimulation'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0549186', 'cui_str': 'Obstructed'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.0224015,"In both groups the symptom severity and quality-of-life scores at 1-year follow-up did not differ significantly from those recorded at the end of treatment.
","[{'ForeName': 'Dajana', 'Initials': 'D', 'LastName': 'Cuicchi', 'Affiliation': ""Surgery of the Alimentary Tract, Department of Medical and Surgical Sciences, Sant'Orsola- Malpighi Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Di Fabio', 'Affiliation': ""Division of Medical Oncology, Sant'Orsola- Malpighi Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Guido', 'Affiliation': 'Radiation Oncology Unit, Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy.'}, {'ForeName': 'Fabiola Lorena Rojas', 'Initials': 'FLR', 'LastName': 'Llimpe', 'Affiliation': ""Division of Medical Oncology, Sant'Orsola- Malpighi Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy.""}, {'ForeName': 'Alessio G', 'Initials': 'AG', 'LastName': 'Morganti', 'Affiliation': 'Radiation Oncology Unit, Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ardizzoni', 'Affiliation': ""Division of Medical Oncology, Sant'Orsola- Malpighi Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy.""}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Coscia', 'Affiliation': ""Surgery of the Alimentary Tract, Department of Medical and Surgical Sciences, Sant'Orsola- Malpighi Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy.""}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Poggioli', 'Affiliation': ""Surgery of the Alimentary Tract, Department of Medical and Surgical Sciences, Sant'Orsola- Malpighi Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy.""}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000001614']
2011,33149114,Hormonal contraception alters vaginal microbiota and cytokines in South African adolescents in a randomized trial.,"Young women in sub-Saharan Africa are disproportionally affected by HIV infection and unintended pregnancies. However, hormonal contraceptive (HC) use may influence HIV risk through changes in genital tract microbiota and inflammatory cytokines. To investigate this, 130 HIV negative adolescent females aged 15-19 years were enrolled into a substudy of UChoose, an open-label randomized crossover study (NCT02404038), comparing acceptability and contraceptive product preference as a proxy for HIV prevention delivery methods. Participants were randomized to injectable norethisterone enanthate (Net-En), combined oral contraceptives (COC) or etonorgesterol/ethinyl estradiol combined contraceptive vaginal ring (CCVR) for 16 weeks, then crossed over to another HC for 16 weeks. Cervicovaginal samples were collected at baseline, crossover and exit for characterization of the microbiota and measurement of cytokine levels; primary endpoints were cervical T cell activation, vaginal microbial diversity and cytokine concentrations. Adolescents randomized to COCs had lower vaginal microbial diversity and relative abundance of HIV risk-associated taxa compared to Net-En or CCVR. Cervicovaginal inflammatory cytokine concentrations were significantly higher in adolescents randomized to CCVR compared to COC and Net-En. This suggests that COC use may induce an optimal vaginal ecosystem by decreasing bacterial diversity and inflammatory taxa, while CCVR use is associated with genital inflammation.",2020,Cervicovaginal inflammatory cytokine concentrations were significantly higher in adolescents randomized to CCVR compared to COC and Net-En.,"['South African adolescents', '130 HIV negative adolescent females aged 15-19 years']","['hormonal contraceptive (HC', 'COC', 'COCs', 'Hormonal contraception', 'CCVR', 'injectable norethisterone enanthate (Net-En), combined oral contraceptives (COC) or etonorgesterol/ethinyl estradiol combined contraceptive vaginal ring (CCVR']","['cervical T cell activation, vaginal microbial diversity and cytokine concentrations', 'vaginal microbial diversity and relative abundance of HIV risk-associated taxa', 'Cervicovaginal inflammatory cytokine concentrations']","[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C2985296', 'cui_str': 'Hormonal contraception'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0068981', 'cui_str': 'Norethindrone enanthate'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",,0.122898,Cervicovaginal inflammatory cytokine concentrations were significantly higher in adolescents randomized to CCVR compared to COC and Net-En.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Balle', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Iyaloo N', 'Initials': 'IN', 'LastName': 'Konstantinus', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Shameem Z', 'Initials': 'SZ', 'LastName': 'Jaumdally', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Enock', 'Initials': 'E', 'LastName': 'Havyarimana', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Lennard', 'Affiliation': 'Department of Integrative Biomedical Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Esra', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Shaun L', 'Initials': 'SL', 'LastName': 'Barnabas', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Anna-Ursula', 'Initials': 'AU', 'LastName': 'Happel', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Moodie', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gill', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Pidwell', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Ulas', 'Initials': 'U', 'LastName': 'Karaoz', 'Affiliation': 'Earth and Environmental Science, Lawrence Berkeley National Laboratories, Berkeley, CA, 94720, USA.'}, {'ForeName': 'Eoin', 'Initials': 'E', 'LastName': 'Brodie', 'Affiliation': 'Earth and Environmental Science, Lawrence Berkeley National Laboratories, Berkeley, CA, 94720, USA.'}, {'ForeName': 'Venessa', 'Initials': 'V', 'LastName': 'Maseko', 'Affiliation': 'National Institute for Communicable Diseases, Sandringham, Johannesburg, South Africa.'}, {'ForeName': 'Hoyam', 'Initials': 'H', 'LastName': 'Gamieldien', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Bosinger', 'Affiliation': 'Department of Pathology & Laboratory Medicine, Emory University School of Medicine; Division of Microbiology and Immunology, Yerkes National Primate Research Center, Atlanta, GA, USA.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology, Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jo-Ann S', 'Initials': 'JS', 'LastName': 'Passmore', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Heather B', 'Initials': 'HB', 'LastName': 'Jaspan', 'Affiliation': 'Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa. hbjaspan@gmail.com.'}]",Nature communications,['10.1038/s41467-020-19382-9']
2012,33149130,"Daratumumab, lenalidomide, and dexamethasone in relapsed/refractory myeloma: a cytogenetic subgroup analysis of POLLUX.","High cytogenetic risk abnormalities confer poor outcomes in multiple myeloma patients. In POLLUX, daratumumab/lenalidomide/dexamethasone (D-Rd) demonstrated significant clinical benefit versus lenalidomide/dexamethasone (Rd) in relapsed/refractory multiple myeloma (RRMM) patients. We report an updated subgroup analysis of POLLUX based on cytogenetic risk. The cytogenetic risk was determined using fluorescence in situ hybridization/karyotyping; patients with high cytogenetic risk had t(4;14), t(14;16), or del17p abnormalities. Minimal residual disease (MRD; 10 -5 ) was assessed via the clonoSEQ ® assay V2.0. 569 patients were randomized (D-Rd, n = 286; Rd, n = 283); 35 (12%) patients per group had high cytogenetic risk. After a median follow-up of 44.3 months, D-Rd prolonged progression-free survival (PFS) versus Rd in standard cytogenetic risk (median: not estimable vs 18.6 months; hazard ratio [HR], 0.43; P < 0.0001) and high cytogenetic risk (median: 26.8 vs 8.3 months; HR, 0.34; P = 0.0035) patients. Responses with D-Rd were deep, including higher MRD negativity and sustained MRD-negativity rates versus Rd, regardless of cytogenetic risk. PFS on subsequent line of therapy was improved with D-Rd versus Rd in both cytogenetic risk subgroups. The safety profile of D-Rd by cytogenetic risk was consistent with the overall population. These findings demonstrate the improved efficacy of daratumumab plus standard of care versus standard of care in RRMM, regardless of cytogenetic risk.",2020,"After a median follow-up of 44.3 months, D-Rd prolonged progression-free survival (PFS) versus Rd in standard cytogenetic risk (median: not estimable vs 18.6 months; hazard ratio [HR], 0.43; P < 0.0001) and high cytogenetic risk (median: 26.8 vs 8.3 months; HR, 0.34; P = 0.0035) patients.","['relapsed/refractory multiple myeloma (RRMM) patients', 'multiple myeloma patients', '569 patients']","['Daratumumab, lenalidomide, and dexamethasone', 'lenalidomide/dexamethasone (Rd', 'POLLUX, daratumumab/lenalidomide/dexamethasone']","['higher MRD negativity and sustained MRD-negativity rates', 'high cytogenetic risk', 'cytogenetic risk', 'D-Rd prolonged progression-free survival (PFS']","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}]","[{'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetics'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",569.0,0.0681631,"After a median follow-up of 44.3 months, D-Rd prolonged progression-free survival (PFS) versus Rd in standard cytogenetic risk (median: not estimable vs 18.6 months; hazard ratio [HR], 0.43; P < 0.0001) and high cytogenetic risk (median: 26.8 vs 8.3 months; HR, 0.34; P = 0.0035) patients.","[{'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA. jlkaufm@emory.edu.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'The National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Dalhousie University and Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Lotfi', 'Initials': 'L', 'LastName': 'Benboubker', 'Affiliation': ""Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours, France.""}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': ""St James's Institute of Oncology, Leeds Teaching Hospitals National Health Service Trust and University of Leeds, Leeds, UK.""}, {'ForeName': 'Merav', 'Initials': 'M', 'LastName': 'Leiba', 'Affiliation': 'Assuta Ashdod University Hospital, Faculty of Health Science Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Morton', 'Affiliation': 'Icon Cancer Care, South Brisbane, QLD, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Joy Ho', 'Affiliation': 'Institute of Haematology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Kihyun', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takezako', 'Affiliation': 'Department of Hematology, National Hospital Organization Disaster Medical Center of Japan, Tachikawa, Japan.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Hematology, University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Sutherland', 'Affiliation': 'Leukemia/Bone Marrow Transplant Program, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Magen', 'Affiliation': 'Department of Hematology Chaim Sheba Medical Center, Ramat-Gan, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Jin Seok', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Yonsei University College of Medicine, Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Miles Prince', 'Affiliation': 'Cabrini Hospital, Epworth HealthCare and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Cochrane', 'Affiliation': 'Gold Coast University Hospital and Griffiths University, Southport, QLD, Australia.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Oriol', 'Affiliation': ""Institut Català d'Oncologia i Institut Josep Carreras, Hospital Germans Trias I Pujol, Barcelona, Spain.""}, {'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'University of Calgary, Arnie Charbonneau Cancer Institute, Calgary, AB, Canada.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': ""O'Rourke"", 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Trivedi', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Tineke', 'Initials': 'T', 'LastName': 'Casneuf', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Krevvata', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Medical Affairs, Horsham, PA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kobos', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Avet-Loiseau', 'Affiliation': 'Unite de Genomique du Myelome, IUC-Oncopole, Toulouse, France.'}, {'ForeName': 'Saad Z', 'Initials': 'SZ', 'LastName': 'Usmani', 'Affiliation': 'Levine Cancer Institute/Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San-Miguel', 'Affiliation': 'Clínica Universidad de Navarra-Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Centro de Investigación Biomédica en Red de Cáncer, Pamplona, Spain.'}]",Blood cancer journal,['10.1038/s41408-020-00375-2']
2013,33149404,"Comparative Evaluation of Dentin Removal and Taper of Root Canal Preparation of Hand K File, ProTaper Rotary File, and Kedo S Rotary File in Primary Molars Using Cone-beam Computed Tomography.","Various rotary endodontic instruments were used and studied for the root canal preparation of the primary teeth. Recently, a new venture evolved in the field of pediatric endodontic, which was Kedo S rotary files. These are the files designed exclusively for root canal preparation of the primary teeth.
Aim
The study aimed to comparatively evaluate the dentin removal and taper of root canal preparation of Hand K files, Rotary Prosper files, and Rotary Kedo S files using cone-beam computed tomography (CBCT) and instrumentation time using stopwatch in primary molars.
Materials and methods
Sixty-three root canals of maxillary and mandibular primary molars were included in the study. The root canals were randomly assigned to Hand K file (group I), Rotary ProTaper file (group II), and Rotary Kedo S file (group III). Dentin removal and taper of the root canal preparations were evaluated by using CBCT.
Results
All the three file systems do not show any statistical significant differences at middle third and apical third but at coronal third, Kedo S removed significantly less amount of dentin as compared to the Hand K file. Taper of the preparations did not show significant differences, even though the rotary files showed good taper in maximum number of root canals.
Conclusion
Although not much statistical significant differences were observed in our study, the rotary file system performed slightly better in root canal preparations in primary molars.
How to cite this article
Seema T, Ahammed H, Parul S, et al . Comparative Evaluation of Dentin Removal and Taper of Root Canal Preparation of Hand K File, ProTaper Rotary File, and Kedo S Rotary File in Primary Molars Using Cone-beam Computed Tomography. Int J Clin Pediatr Dent 2020;13(4):332-336.",2020,"Although not much statistical significant differences were observed in our study, the rotary file system performed slightly better in root canal preparations in primary molars.
","['Materials and methods\n\n\nSixty-three root canals of maxillary and mandibular primary molars', 'primary molars', 'Primary Molars']","['Rotary ProTaper file (group II), and Rotary Kedo S file', 'Dentin Removal and Taper of Root Canal Preparation of Hand K File, ProTaper Rotary File, and Kedo S Rotary File', 'dentin removal and taper of root canal preparation of Hand K files, Rotary Prosper files, and Rotary Kedo S files using cone-beam computed tomography (CBCT']",['Dentin removal and taper of the root canal preparations'],"[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0282543', 'cui_str': 'Root canal preparation'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0282543', 'cui_str': 'Root canal preparation'}]",,0.0295222,"Although not much statistical significant differences were observed in our study, the rotary file system performed slightly better in root canal preparations in primary molars.
","[{'ForeName': 'Thakur', 'Initials': 'T', 'LastName': 'Seema', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, HP Government Dental College and Hospital, Shimla, Himachal Pradesh, India.'}, {'ForeName': 'Haseeb', 'Initials': 'H', 'LastName': 'Ahammed', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, HP Government Dental College and Hospital, Shimla, Himachal Pradesh, India.'}, {'ForeName': 'Singhal', 'Initials': 'S', 'LastName': 'Parul', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, HP Government Dental College and Hospital, Shimla, Himachal Pradesh, India.'}, {'ForeName': 'Jayam', 'Initials': 'J', 'LastName': 'Cheranjeevi', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, HP Government Dental College and Hospital, Shimla, Himachal Pradesh, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1787']
2014,33149405,Pulp Revascularization/Revitalization of Bilateral Upper Necrotic Immature Permanent Central Incisors with Blood Clot vs Platelet-rich Fibrin Scaffolds-A Split-mouth Double-blind Randomized Controlled Trial.,"Objectives
Clinical and radiographic evaluation of the regeneration of bilateral necrotic upper permanent central incisors with open apex using blood clot (BC) and platelet-rich fibrin (PRF) scaffolds.
Trial design
Split-mouth double-blind parallel arm randomized controlled clinical trial.
Materials and methods
Randomization and blinding: The study started with 15 patients with bilateral necrotic upper permanent central incisors with open apex. Computer-generated tables were used to allocate treatments. The two maxillary central incisors were randomly assigned to either the control (BC scaffold) or the examined (PRF scaffold) groups. Participants: Thirteen patients aged 8-14 years fulfilled the study requirements. Follow-up was performed for 3, 6, 9, and 12 months. Standardized radiographs were collected each 3 months, and difference in measurements was calculated using Image J software. Primary outcomes measured were sinus/fistula formation, pain complaint, mobility grade, and swelling presence/absence. Radiographic: Root length elongation and increase in root thickness. Secondary outcomes were sensibility test and crown color change. Radiographic: Change in bone density and apical diameter. Radiographs that were standardized used during the follow-up time, and occurred changes were calculated using Image J software.
Results
One patient was lost during follow-up; therefore, 24 treated teeth were analyzed, they showed 100% success rate. Platelet-rich fibrin teeth displayed a statistically significant growth in radiographic root length and width, increased periapical bone density, and a reduction in apical diameter when compared with BC. At the end of the follow-up period, all treated teeth were negative to sensibility test. Blood clot displayed greater crown discoloration in comparison to PRF group.
Conclusion
For teeth with open apex and necrotic pulp, revascularization using PRF is an appropriate substitute to BC.
How to cite this article
Rizk HM, Salah AL-Deen MS, Emam AA. Pulp Revascularization/Revitalization of Bilateral Upper Necrotic Immature Permanent Central Incisors with Blood Clot vs Platelet-rich Fibrin Scaffolds-A Split-mouth Double-blind Randomized Controlled Trial. Int J Clin Pediatr Dent 2020;13(4):337-343.",2020,"Platelet-rich fibrin teeth displayed a statistically significant growth in radiographic root length and width, increased periapical bone density, and a reduction in apical diameter when compared with BC.","['Participants', '15 patients with bilateral necrotic upper permanent central incisors with open apex', 'two maxillary central incisors', 'Radiographic', 'Thirteen patients aged 8-14 years fulfilled the study requirements']","['Blood Clot vs Platelet-rich Fibrin Scaffolds', 'bilateral necrotic upper permanent central incisors with open apex using blood clot (BC) and platelet-rich fibrin (PRF']","['radiographic root length and width, increased periapical bone density', 'root thickness', 'bone density and apical diameter', 'sinus/fistula formation, pain complaint, mobility grade, and swelling presence/absence', 'sensibility test and crown color change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0475330', 'cui_str': 'Color change'}]",13.0,0.266433,"Platelet-rich fibrin teeth displayed a statistically significant growth in radiographic root length and width, increased periapical bone density, and a reduction in apical diameter when compared with BC.","[{'ForeName': 'Hazim Mohamed', 'Initials': 'HM', 'LastName': 'Rizk', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Mohamed Sherif', 'Initials': 'MS', 'LastName': 'Salah Al-Deen', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Asmaa Aly', 'Initials': 'AA', 'LastName': 'Emam', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Suez Canal University, Ismailia, Egypt.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1788']
2015,33149412,A Randomized Split Mouth Clinical Trial Comparing Mineral Trioxide Aggregate with a New Fast-setting Calcium Silicate Cement in Direct Pulp Capping of Primary Molars: A Preliminary Report from a Long-term Follow-up.,"Aims and objectives
This study was done to compare the success rate of a novel fast-setting calcium silicate cement (protooth) with mineral trioxide aggregate (MTA) in direct pulp capping (DPC) of primary molars.
Materials and methods
Forty-five patients with an age range of 5-7 years with 90 bilaterally symmetrical primary molars that had deep carious lesions were incorporated into a randomized split mouth clinical trial. Initially, the caries was removed. Afterward, the teeth randomly underwent DPC with either MTA or protooth. Restoration of the teeth was done by amalgam fillings. Clinical and radiographic examinations were performed after 6 months. To analyze the data, Chi-square statistical test was used. Values < 0.05 were considered statistically significant.
Results
After 6 months of follow-up, 88 teeth on 44 patients were available for evaluation. The MTA-treated teeth showed a success rate of 95.5%, while the same outcome for the protooth-treated teeth was 93.2%. The difference did not yield a statistically significant difference ( p value > 0.05).
Conclusion
The findings of this study showed favorable results for the novel calcium silicate cement ""protooth"" when compared to the outcomes of MTA in the DPC of primary molars.
Clinical significance
The constant need for the development of more effective materials in the modern pediatric dentistry makes this novel cement of particular interest for pedodontists. The new cement is biocompatible, hydrophilic, and has fast-setting time and adequate tensile strength with favorable clinical results in the DPC of primary molars which can benefit pedodontists in their clinical practice.
How to cite this article
Shahamfar M, Azima N, Erfanparast L. A Randomized Split Mouth Clinical Trial Comparing Mineral Trioxide Aggregate with a New Fast-setting Calcium Silicate Cement in Direct Pulp Capping of Primary Molars: A Preliminary Report from a Long-term Follow-up. Int J Clin Pediatr Dent 2020;13(4):390-394.",2020,"The MTA-treated teeth showed a success rate of 95.5%, while the same outcome for the protooth-treated teeth was 93.2%.","['Materials and methods\n\n\nForty-five patients with an age range of 5-7 years with 90 bilaterally symmetrical primary molars that had deep carious lesions', 'direct pulp capping (DPC) of primary molars', 'Direct Pulp Capping of Primary Molars', 'Primary Molars']","['Mineral Trioxide Aggregate with a New Fast-setting Calcium Silicate Cement', 'novel fast-setting calcium silicate cement (protooth) with mineral trioxide aggregate (MTA']",['success rate'],"[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0011402', 'cui_str': 'Capping, Dental Pulp'}]","[{'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0054483', 'cui_str': 'calcium silicate'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}]",[],44.0,0.0292857,"The MTA-treated teeth showed a success rate of 95.5%, while the same outcome for the protooth-treated teeth was 93.2%.","[{'ForeName': 'Mohamadreza', 'Initials': 'M', 'LastName': 'Shahamfar', 'Affiliation': 'Department of Orthodontics, Tabriz Branch, Islamic Azad University, College of Dentistry, Tabriz, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Azima', 'Affiliation': 'Department of Pediatric Dentistry, Tabriz University of Medical Sciences, School of Dentistry, Tabriz, East Azerbaijan, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Erfanparast', 'Affiliation': 'Department of Pediatric Dentistry, Tabriz University of Medical Sciences, School of Dentistry, Tabriz, East Azerbaijan, Iran.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1801']
2016,33149439,In Vitro Comparative Evaluation of Effectiveness of Sodium Hypochlorite with Conventional Irrigation Method versus EndoVac and Ultrasonic Irrigation in the Elimination of Enterococcus faecalis from Root Canals.,"Aim
The aim of this study was to compare the decrease in bacterial population in the root canals with 2.5% sodium hypochlorite (NaOCl) and three irrigation systems: Conventional Needle Irrigation, Passive Ultrasonic Irrigation, and EndoVac Apical Negative Pressure Irrigation system.
Materials and Methods
Access open was carried out in 48 extracted single-rooted maxillary and mandibular human premolar teeth. The canals were instrumented 1 mm short of apical foramen up to No. 50 size file; irrigated and apical foramen was sealed with cyanoacrylate. The teeth were mounted in plaster and autoclaved for 20 min at 121°C. The plaster blocks containing the teeth were inoculated with Enterococcus faecalis and incubated at 37°C for 24 h. The specimens divided randomly into four groups ( n = 12) depending on the type of irrigation system used: Group 1: Conventional Irrigation Needle, Group 2: Ultrasonic system, Group 3: EndoVac Negative Pressure Irrigation system used with 2.5% NaOCl, and Group 4: Control group, normal saline irrigation. The normal saline is used as control. The samples were collected using 45 size sterile paper points and quantitative bacterial assessment was carried out by seeding each dilution on plates containing brain heart infusion broth. Then, incubated at 37°C for 7 days and colony-forming units were counted. Data obtained were statistically analyzed.
Results
Statistically, EndoVac irrigation systems were more effective in reducing the number of bacteria than the other irrigation systems.
Conclusion
EndoVac irrigation system was more effective in reducing bacterial numbers in infected root canals than the other two irrigation systems.",2020,"Statistically, EndoVac irrigation systems were more effective in reducing the number of bacteria than the other irrigation systems.
","['48 extracted single-rooted maxillary and mandibular human premolar teeth', 'Enterococcus faecalis from Root Canals']","['Sodium Hypochlorite with Conventional Irrigation Method versus EndoVac and Ultrasonic Irrigation', 'Conventional Irrigation Needle, Group 2: Ultrasonic system, Group 3: EndoVac Negative Pressure Irrigation system used with 2.5% NaOCl, and Group 4: Control group, normal saline irrigation', 'sodium hypochlorite (NaOCl) and three irrigation systems: Conventional Needle Irrigation, Passive Ultrasonic Irrigation, and EndoVac Apical Negative Pressure Irrigation system', 'apical foramen up to No. 50 size file; irrigated and apical foramen was sealed with cyanoacrylate']","['bacterial numbers', 'number of bacteria']","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}]","[{'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0524789', 'cui_str': 'Structure of apical foramen of tooth'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",48.0,0.0201159,"Statistically, EndoVac irrigation systems were more effective in reducing the number of bacteria than the other irrigation systems.
","[{'ForeName': 'Silppa', 'Initials': 'S', 'LastName': 'Thulaseedharan', 'Affiliation': 'Department of Conservative Dentistry & Endodontics, A J Institute of Dental Sciences, Kuntikana, Mangalore, Karnataka, and India.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Kabbinale', 'Affiliation': 'Department of Conservative Dentistry & Endodontics, A J Institute of Dental Sciences, Kuntikana, Mangalore, Karnataka, and India.'}, {'ForeName': 'Anand Kumar', 'Initials': 'AK', 'LastName': 'Vallabhdas', 'Affiliation': 'Department of Conservative Dentistry & Endodontics, A J Institute of Dental Sciences, Kuntikana, Mangalore, Karnataka, and India.'}, {'ForeName': 'Vijay Kumar Chittenahalli', 'Initials': 'VKC', 'LastName': 'Ninge Gowda', 'Affiliation': 'Department of Conservative Dentistry & Endodontics, A J Institute of Dental Sciences, Kuntikana, Mangalore, Karnataka, and India.'}, {'ForeName': 'Kusuma Shikaripura', 'Initials': 'KS', 'LastName': 'Chandrashekar', 'Affiliation': 'Department of Conservative Dentistry & Endodontics, A J Institute of Dental Sciences, Kuntikana, Mangalore, Karnataka, and India.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Marulappa', 'Affiliation': 'Department of Oral pathology and Microbiology, Subbaiah Institute of Dental Sciences. Shivamogga, Karnataka, India.'}]",Journal of pharmacy & bioallied sciences,['10.4103/jpbs.JPBS_37_20']
2017,33149443,"A Comparative Study to Evaluate the Effects of Probiotic Curd on Streptococcus mutans , Bifidobacterium dentium , and pH of Saliva in Caries-free Children: An In Vivo Study.","Background
Dental caries is one of the commonest oral diseases that require early stages of prevention and intervention. The primary organisms related to dental caries are streptococcus mutans and lactobacilli. In the past decades, some of the non-pathogenic bacteria called probiotics have been added to the food products for the beneficial effect of human health. Intake of probiotic food products has been shown to have beneficial effects on the oral tissues. Hence the present study aimed to compare the levels of salivary pH, S. mutans, B. dentium counts in children consuming probiotic and non-probiotic curd.
Methods and Material
40 healthy caries free children were randomly allocated into two groups. First baseline salivary samples were collected from all the participants and tested for salivary pH, salivary B. dentium and S. mutans count. After collecting the baseline values test group of children were provided with probiotic curd whereas the control group were provided with non probiotic curd for 15 days. After 15 days of consumption of these dairy products, salivary samples were collected again and tested for salivary pH, salivary B. dentium and S. mutans count.
Results
Probiotic curd was found to be more effective in reducing the colony counts of B.dentium and S.mutans. There was a marginal decrease in pH in both the groups but was well above the critical pH.
Conclusions
Probiotic curd showed considerable level of decrease in colony counts of B.dentium, S.mutans and salivary pH when compared to normal curd.",2020,"Results
Probiotic curd was found to be more effective in reducing the colony counts of B.dentium and S.mutans.","['40 healthy caries free children', 'Caries-free Children', 'children consuming probiotic and non-probiotic curd']",['Probiotic Curd'],"['colony counts of B.dentium, S.mutans and salivary pH', 'marginal decrease in pH']","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0558296', 'cui_str': 'Curds'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0558296', 'cui_str': 'Curds'}]","[{'cui': 'C0368993', 'cui_str': 'Colony count'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",40.0,0.0283817,"Results
Probiotic curd was found to be more effective in reducing the colony counts of B.dentium and S.mutans.","[{'ForeName': 'Nandhini B', 'Initials': 'NB', 'LastName': 'Selvarajan', 'Affiliation': ""Senior lecturer, Department of Pedodontics and Preventive dentistry, Vinayaka Mission's Sankarachariyar Dental College, Vinayaka Mission's Research Foundation-Deemed to be University, Salem, Tamil Nadu, India.""}, {'ForeName': 'Suresh Kumar', 'Initials': 'SK', 'LastName': 'Vasaviah', 'Affiliation': ""Professor, Head of the Department, Department of Pedodontics and Preventive dentistry, Vinayaka Mission's Sankarachariyar Dental College, Vinayaka Mission's Research Foundation-Deemed to be University, Salem, Tamil Nadu, India.""}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Krishnan', 'Affiliation': ""Former Professor, Department of Pedodontics and preventive dentistry, Vinayaka Mission's Sankarachariyar Dental College, Vinayaka Mission's Research Foundation-Deemed to be University, Salem, Tamil Nadu, India.""}]",Journal of pharmacy & bioallied sciences,['10.4103/jpbs.JPBS_42_20']
2018,33149481,Relation between Apical Seal and Apical Preparation Diameter: An In Vitro Study.,"Background
The current recommendations for the apical preparation diameter, one of the most important mechanical imperatives in the apical third preparation, are to preserve the apical foramen in its original position along with its narrowest diameter to avoid any complication such as tearing, zipping, or transport of the foramen. The aim of our study was to see the correlation between apical seal and apical preparation diameter.
Materials and Methods
In total, 90 extracted maxillary incisors were randomly allocated into three groups of 30 teeth each according to the apical preparation size: Group 1: finishing file F1 corresponding to size 20 reached the working length, Group 2: prepared up to size 30 corresponding to finishing file F3, and Group 3: prepared up to size 50 corresponding to finishing file F5. After the filling of the root canals, the teeth were isolated and immersed in a dye solution, then cut longitudinally, photographed, and the dye penetration were calculated using a computer software.
Results
Comparison of the three different apical preparation sizes showed no statistically significant differences regarding the apical microleakage.
Conclusion
The most important value of the dye penetration was observed in the group with the largest apical diameter.",2020,"Results
Comparison of the three different apical preparation sizes showed no statistically significant differences regarding the apical microleakage.
",['90 extracted maxillary incisors'],"['Apical Seal and Apical Preparation Diameter', 'finishing file F1 corresponding to size 20 reached the working length, Group 2: prepared up to size 30 corresponding to finishing file F3, and Group 3: prepared up to size 50 corresponding to finishing file F5']","['apical microleakage', 'dye penetration']","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}]",90.0,0.0291532,"Results
Comparison of the three different apical preparation sizes showed no statistically significant differences regarding the apical microleakage.
","[{'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Saluja', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, JCD Dental College, Vidyapeeth, Sirsa, Haryana, India.'}, {'ForeName': 'Shugufta', 'Initials': 'S', 'LastName': 'Mir', 'Affiliation': 'Department of Restorative Dental Sciences, College of Dentistry, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Shashit S', 'Initials': 'SS', 'LastName': 'Bavabeedu', 'Affiliation': 'Department of Restorative Dental Sciences, College of Dentistry, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Suraj', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Restorative Dental Sciences, College of Dentistry, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Anshad M', 'Initials': 'AM', 'LastName': 'Abdulla', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontic Sciences, College of Dentistry, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Suheel M', 'Initials': 'SM', 'LastName': 'Baba', 'Affiliation': 'Department of Restorative Dental Sciences, College of Dentistry, King Khalid University, Abha, Kingdom of Saudi Arabia.'}]",Journal of pharmacy & bioallied sciences,['10.4103/jpbs.JPBS_97_20']
2019,33149484,"Microbiological and Clinical evaluation of Neem gel and Chlorhexidine gel on Dental Plaque and Gingivitis in 20-30 Years Old Adults: A Randomized Parallel-Armed, Double-Blinded Controlled Trial.","Background
The etiological relationship between the plaque and the gingival inflammation has been long established. The long-term use of chemical antiplaque agents may lead to side effects such as teeth staining and alteration of taste. Therefore, natural plant extracts with potential antibacterial and anti-inflammatory activity have been explored, which are equally effective and safe for long-term use.
Objective
The aim of this study was to compare and evaluate effect of neem gel and chlorhexidine (CHX) gel on dental plaque, gingivitis, and bacterial count of Streptococcus mutans and Lactobacilli among 20-30-year-old school teachers in a city of western Maharashtra, over 90 days' usage.
Materials and Methods
A double-blind, parallel armed, controlled, randomized clinical study was conducted among 60 school teachers of 20-30 years' age group for 90 days. The two study groups were as follows: Group A--2.5% neem gel ( n = 30) and Group B--0.2% CHX gel ( n = 30). The plaque scores were recorded by Plaque Index (Löe H. The gingival index, the plaque index and the retention index systems. J Periodontol 1967;38:610-6) and gingival scores by Gingival Index (Löe H, Silness J. Periodontal disease in pregnancy. Acta Odontol Scand 1963;21:533-51). Streptococcus mutans and Lactobacilli species count by conventional culture method was carried out at baseline, 30th day and 90thday. Considering P value <0.05 as statistically significant, intergroup comparison was performed using unpaired t test. One-way analysis of variance (ANOVA) test was used followed by Tukey's post hoc test for intragroup comparison.
Results
The mean plaque, gingival scores, and microbial count of S. mutans and Lactobacilli showed significant reduction at 30th and 90th day in neem gel group as well as CHX gel group ( P < 0.05). None of the parameter showed any significant change at 30th and 90th day ( P > 0.05) on intergroup comparison.
Conclusion
The neem gel showed significant decrease in dental plaque, gingival inflammation, and microbial counts, which was comparable to CHX gel proving to be a good herbal alternative. No side effects were reported for use of neem gel over considered period of time.",2020,"The mean plaque, gingival scores, and microbial count of S. mutans and Lactobacilli showed significant reduction at 30th and 90th day in neem gel group as well as CHX gel group ( P < 0.05).","['20-30 Years Old Adults', ""20-30-year-old school teachers in a city of western Maharashtra, over 90 days' usage"", ""60 school teachers of 20-30 years' age group for 90 days""]","['CHX gel', 'neem gel and chlorhexidine (CHX) gel', 'Chlorhexidine gel']","['gingival index, the plaque index and the retention index systems', 'dental plaque, gingivitis, and bacterial count of Streptococcus mutans and Lactobacilli', 'gingival scores by Gingival Index (Löe H, Silness J. Periodontal disease in pregnancy', 'Dental Plaque and Gingivitis', 'dental plaque, gingival inflammation, and microbial counts', 'mean plaque, gingival scores, and microbial count of S. mutans and Lactobacilli', 'plaque scores']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036374', 'cui_str': 'School teacher'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1095052', 'cui_str': 'Melia azadirachta'}]","[{'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0427923,"The mean plaque, gingival scores, and microbial count of S. mutans and Lactobacilli showed significant reduction at 30th and 90th day in neem gel group as well as CHX gel group ( P < 0.05).","[{'ForeName': 'Gargi', 'Initials': 'G', 'LastName': 'Nimbulkar', 'Affiliation': 'Department of Public Health Dentistry, Sharad Pawar Dental College & Hospital (SPDC), Datta Meghe Institute of Medical Sciences (DMIMS), Wardha, Maharashtra, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Garacha', 'Affiliation': 'Department of Public Health Dentistry, Sinhgad Dental College and Hospital, Pune, Maharashtra, India.'}, {'ForeName': 'Vittaldas', 'Initials': 'V', 'LastName': 'Shetty', 'Affiliation': 'Department of Public Health Dentistry, Sinhgad Dental College and Hospital, Pune, Maharashtra, India.'}, {'ForeName': 'Ketaki', 'Initials': 'K', 'LastName': 'Bhor', 'Affiliation': 'Department of Public Health Dentistry, Sinhgad Dental College and Hospital, Pune, Maharashtra, India.'}, {'ForeName': 'Kumar Chandan', 'Initials': 'KC', 'LastName': 'Srivastava', 'Affiliation': 'Department of Oral & Maxillofacial Surgery & Diagnostic Sciences, College of Dentistry, Jouf University, Sakakah, Kingdom of Saudi Arabia.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Shrivastava', 'Affiliation': 'Department of Preventive Dentistry, College of Dentistry, Jouf University, Sakakah, Kingdom of Saudi Arabia.'}, {'ForeName': 'Mohammed G', 'Initials': 'MG', 'LastName': 'Sghaireen', 'Affiliation': 'Department of Prosthetic Dental Sciences, College of Dentistry, Jouf University, Sakakah, Kingdom of Saudi Arabia.'}]",Journal of pharmacy & bioallied sciences,['10.4103/jpbs.JPBS_101_20']
2020,33146763,"Safety and cost-effectiveness of individualised screening for diabetic retinopathy: the ISDR open-label, equivalence RCT.","AIMS/HYPOTHESIS
Using variable diabetic retinopathy screening intervals, informed by personal risk levels, offers improved engagement of people with diabetes and reallocation of resources to high-risk groups, while addressing the increasing prevalence of diabetes. However, safety data on extending screening intervals are minimal. The aim of this study was to evaluate the safety and cost-effectiveness of individualised, variable-interval, risk-based population screening compared with usual care, with wide-ranging input from individuals with diabetes.
METHODS
This was a two-arm, parallel-assignment, equivalence RCT (minimum 2 year follow-up) in individuals with diabetes aged 12 years or older registered with a single English screening programme. Participants were randomly allocated 1:1 at baseline to individualised screening at 6, 12 or 24 months for those at high, medium and low risk, respectively, as determined at each screening episode by a risk-calculation engine using local demographic, screening and clinical data, or to annual screening (control group). Screening staff and investigators were observer-masked to allocation and interval. Data were collected within the screening programme. The primary outcome was attendance (safety). A secondary safety outcome was the development of sight-threatening diabetic retinopathy. Cost-effectiveness was evaluated within a 2 year time horizon from National Health Service and societal perspectives.
RESULTS
A total of 4534 participants were randomised. After withdrawals, there were 2097 participants in the individualised screening arm and 2224 in the control arm. Attendance rates at first follow-up were equivalent between the two arms (individualised screening 83.6%; control arm 84.7%; difference -1.0 [95% CI -3.2, 1.2]), while sight-threatening diabetic retinopathy detection rates were non-inferior in the individualised screening arm (individualised screening 1.4%, control arm 1.7%; difference -0.3 [95% CI -1.1, 0.5]). Sensitivity analyses confirmed these findings. No important adverse events were observed. Mean differences in complete case quality-adjusted life-years (EuroQol Five-Dimension Questionnaire, Health Utilities Index Mark 3) did not significantly differ from zero; multiple imputation supported the dominance of individualised screening. Incremental cost savings per person with individualised screening were £17.34 (95% CI 17.02, 17.67) from the National Health Service perspective and £23.11 (95% CI 22.73, 23.53) from the societal perspective, representing a 21% reduction in overall programme costs. Overall, 43.2% fewer screening appointments were required in the individualised arm.
CONCLUSIONS/INTERPRETATION
Stakeholders involved in diabetes care can be reassured by this study, which is the largest ophthalmic RCT in diabetic retinopathy screening to date, that extended and individualised, variable-interval, risk-based screening is feasible and can be safely and cost-effectively introduced in established systematic programmes. Because of the 2 year time horizon of the trial and the long time frame of the disease, robust monitoring of attendance and retinopathy rates should be included in any future implementation.
TRIAL REGISTRATION
ISRCTN 87561257 FUNDING: The study was funded by the UK National Institute for Health Research. Graphical abstract.",2020,"Incremental cost savings per person with individualised screening were £17.34 (95% CI 17.02, 17.67) from the National Health Service perspective and £23.11 (95% CI 22.73, 23.53) from the societal perspective, representing a 21% reduction in overall programme costs.","['diabetic retinopathy', 'individuals with diabetes', 'individuals with diabetes aged 12\xa0years or older registered with a single English screening programme', '4534 participants were randomised', '2097 participants in the individualised screening arm and 2224 in the control arm']","['individualised screening', 'individualised, variable-interval, risk-based population screening compared with usual care']","['development of sight-threatening diabetic retinopathy', 'while sight-threatening diabetic retinopathy detection rates', 'safety and cost-effectiveness', 'Safety and cost-effectiveness', 'Attendance rates', 'Incremental cost savings per person with individualised screening', 'adverse events', 'complete case quality-adjusted life-years (EuroQol Five-Dimension Questionnaire, Health Utilities Index Mark 3', 'Cost-effectiveness', 'overall programme costs', 'attendance (safety']","[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C2733251', 'cui_str': 'EuroQoL five dimension questionnaire'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",4534.0,0.329272,"Incremental cost savings per person with individualised screening were £17.34 (95% CI 17.02, 17.67) from the National Health Service perspective and £23.11 (95% CI 22.73, 23.53) from the societal perspective, representing a 21% reduction in overall programme costs.","[{'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Broadbent', 'Affiliation': 'Department of Eye and Vision Science, Institute of Life Course and Medical Sciences, University of Liverpool, Member of Liverpool Health Partners, Liverpool, UK. deborah.broadbent@rlbuht.nhs.uk.'}, {'ForeName': 'Amu', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Eye and Vision Science, Institute of Life Course and Medical Sciences, University of Liverpool, Member of Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cheyne', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Member of Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'James', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lathe', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'Stratton', 'Affiliation': 'Gloucestershire Retinal Research Group, Cheltenham General Hospital, Cheltenham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Mersey Diabetes Support Group, Liverpool, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Moitt', 'Affiliation': 'Clinical Trials Research Centre, Liverpool, UK.'}, {'ForeName': 'Jiten P', 'Initials': 'JP', 'LastName': 'Vora', 'Affiliation': 'Department of Diabetes and Endocrinology, Royal Liverpool University Hospital, Liverpool, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gabbay', 'Affiliation': 'Department of Health Services Research, University of Liverpool, Member of Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'García-Fiñana', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Member of Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Harding', 'Affiliation': 'Department of Eye and Vision Science, Institute of Life Course and Medical Sciences, University of Liverpool, Member of Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-020-05313-2']
2021,33146769,Lysine-urethane-based tissue adhesion for mastectomy-an approach to reducing the seroma rate?,"PURPOSE
Postoperative seromas are a problem in the surgical treatment of breast cancer. The aim of the study was to evaluate whether the lysine-urethane-based tissue adhesive TissuGlu ® without drainage is equal/ non-inferior to standard mastecomy with drainage.
METHODS
The study was designed as a prospective, randomized, multicentre non-inferiority study comparing the use of TissuGlu ® without drainage with standard wound care with a drain insertion in ablative breast procedures. The number of clinical interventions, quality of life and wound complications were followed-up for 90 days in both groups.
RESULTS
Although the statistical power was not reached, twice as many clinical interventions were performed in the TissuGlu ® group than in the drainage group, especially aspirations of clinically relevant seromas (p = 0.014). The TissuGlu ® group produced overall less wound fluid, but developed a clinically relevant seroma (100% vs. 63%) which made an intervention necessary. Less hospitalisation time was observed in the TissuGlu ® group, but the complication rate was higher. There was no significant difference in regards to postoperative pain. In summary the non-inferiority of TissuGlu ® compared to standard drainage couldn't be reached.
DISCUSSION
The present evaluation shows no advantage of the tissue adhesive TissuGlu ® in terms of seroma formation and frequency of intervention compared to a standard drainage for mastectomies, but the shorter inpatient stay certainly has a positive effect on the quality of life.",2020,"The present evaluation shows no advantage of the tissue adhesive TissuGlu ® in terms of seroma formation and frequency of intervention compared to a standard drainage for mastectomies, but the shorter inpatient stay certainly has a positive effect on the quality of life.","['breast cancer', 'ablative breast procedures']","['Lysine-urethane-based tissue adhesion', 'TissuGlu ® without drainage with standard wound care with a drain insertion', 'lysine-urethane-based tissue adhesive TissuGlu ® without drainage']","['Less hospitalisation time', 'seroma rate', 'complication rate', 'clinically relevant seroma', 'quality of life', 'postoperative pain', 'number of clinical interventions, quality of life and wound complications']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0191838', 'cui_str': 'Breast procedure'}]","[{'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0041964', 'cui_str': 'Urethane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0886052', 'cui_str': 'Wound care'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040277', 'cui_str': 'Tissue adhesives'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]",,0.0378079,"The present evaluation shows no advantage of the tissue adhesive TissuGlu ® in terms of seroma formation and frequency of intervention compared to a standard drainage for mastectomies, but the shorter inpatient stay certainly has a positive effect on the quality of life.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Boeer', 'Affiliation': ""Department of Women's Health, University Hospital of Tuebingen, Calwerstraße 7, 72076, Tuebingen, Germany. bettina.boeer@med.uni-tuebingen.de.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Department of Urology, Klinikum Am Steinenberg, Reutlingen, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Schoenfisch', 'Affiliation': ""Research Institute for Women's Health, University of Tuebingen, Tuebingen, Germany.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Röhm', 'Affiliation': ""Department of Women's Health, University Hospital of Tuebingen, Calwerstraße 7, 72076, Tuebingen, Germany.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Paepke', 'Affiliation': 'Department of Obstetrics and Gynaecology, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Oberlechner', 'Affiliation': ""Department of Women's Health, University Hospital of Tuebingen, Calwerstraße 7, 72076, Tuebingen, Germany.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ohlinger', 'Affiliation': 'Department of Gynaecology and Obstetrics, Ernst-Moritz-Arndt University Greifswald, Greifswald, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hartkopf', 'Affiliation': ""Department of Women's Health, University Hospital of Tuebingen, Calwerstraße 7, 72076, Tuebingen, Germany.""}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Brucker', 'Affiliation': ""Department of Women's Health, University Hospital of Tuebingen, Calwerstraße 7, 72076, Tuebingen, Germany.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hahn', 'Affiliation': ""Department of Women's Health, University Hospital of Tuebingen, Calwerstraße 7, 72076, Tuebingen, Germany.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marx', 'Affiliation': 'Department of Plastic, Reconstructive and Breast Surgery, Elblandklinikum Radebeul, Radebeul, Germany.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05801-1']
2022,33150640,Mediators of change in cognitive behavior therapy and interpersonal psychotherapy for eating disorders: A secondary analysis of a transdiagnostic randomized controlled trial.,"OBJECTIVE
Understanding the mechanisms of action of psychological treatments is a key first step in refining and developing more effective treatments. The present study examined hypothesized mediators of change of enhanced cognitive behavior therapy (CBT-E) and interpersonal psychotherapy for eating disorders (IPT-ED).
METHOD
A series of mediation studies were embedded in a randomized controlled trial (RCT) comparing 20 weeks of CBT-E and IPT-ED in a transdiagnostic, non-underweight sample of patients with eating disorders (N = 130) consecutively referred to the service. Three hypothesized mediators of change in CBT-E (regular eating, weighing frequency, and shape checking) and the key hypothesized mediator of IPT-ED (interpersonal problem severity) were studied.
RESULTS
The data supported regular eating as being a mediator of the effect of CBT-E on binge-eating frequency. The findings were inconclusive regarding the role of the other putative mediators of the effects of CBT-E; and were similarly inconclusive for interpersonal problem severity as a mediator of the effect of IPT-ED.
DISCUSSION
This research highlights the potential benefits of embedding mediation studies within RCTs to better understand how treatments work. The findings supported the role of regular eating in reducing patients' binge-eating frequency. Other key hypothesized mediators of CBT-E and IPT-ED were not supported, although the data were not inconsistent with them. Key methodological issues to address in future work include the need to capture both behavioral and cognitive processes of change in CBT-E, and identifying key time points for change in IPT-ED.",2020,"Other key hypothesized mediators of CBT-E and IPT-ED were not supported, although the data were not inconsistent with them.","['patients with eating disorders (N =\u2009130) consecutively referred to the service', 'eating disorders']","['cognitive behavior therapy and interpersonal psychotherapy', 'CBT-E and IPT-ED', 'enhanced cognitive behavior therapy (CBT-E) and interpersonal psychotherapy']","['CBT-E (regular eating, weighing frequency, and shape checking']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}]",,0.0519678,"Other key hypothesized mediators of CBT-E and IPT-ED were not supported, although the data were not inconsistent with them.","[{'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Sivyer', 'Affiliation': 'Department of Psychiatry, Oxford University, Oxford, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Zafra', 'Initials': 'Z', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, Oxford University, Oxford, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Bailey-Straebler', 'Affiliation': 'Department of Psychiatry, Oxford University, Oxford, UK.'}, {'ForeName': 'Marianne E', 'Initials': 'ME', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Psychiatry, Oxford University, Oxford, UK.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Fairburn', 'Affiliation': 'Department of Psychiatry, Oxford University, Oxford, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychiatry, Oxford University, Oxford, UK.'}]",The International journal of eating disorders,['10.1002/eat.23390']
2023,33150681,"Pilot study to reduce interdialytic weight gain by provision of low-sodium, home-delivered meals in hemodialysis patients.","INTRODUCTION
Patients with kidney failure undergoing maintenance hemodialysis (HD) therapy are routinely counseled to reduce dietary sodium intake to ameliorate sodium retention, volume overload, and hypertension. However, low-sodium diet trials in HD are sparse and indicate that dietary education and behavioral counseling are ineffective in reducing sodium intake. This study aimed to determine whether 4 weeks of low-sodium, home-delivered meals in HD patients reduces interdialytic weight gain (IDWG). Secondary outcomes included changes in dietary sodium intake, thirst, xerostomia, blood pressure, volume overload, and muscle sodium concentration.
METHODS
Twenty HD patients (55 ± 12 years, body mass index [BMI] 40.7 ± 16.6 kg/m 2 ) were enrolled in this study. Participants followed a usual (control) diet for the first 4 weeks followed by 4 weeks of three low-sodium, home-delivered meals per day. We measured IDWG, hydration status (bioimpedance), standardized blood pressure (BP), food intake (3-day dietary recall), and muscle sodium (magnetic resonance imaging) at baseline (0 M), after the 4-week period of usual diet (1 M), and after the meal intervention (2 M).
FINDINGS
The low-sodium meal intervention significantly reduced IDWG when compared to the control period (-0.82 ± 0.14 kg; 95% confidence interval, -0.55 to -1.08 kg; P < 0.001). There were also 1 month (1 M) to 2 month (2 M) reductions in dietary sodium intake (-1687 ± 297 mg; P < 0.001); thirst score (-4.4 ± 1.3; P = 0.003), xerostomia score (-6.7 ± 1.9; P = 0.002), SBP (-18.0 ± 3.6 mmHg; P < 0.001), DBP (-5.9 ± 2.0 mmHg; P = 0.008), and plasma phosphorus -1.55 ± 0.21 mg/dL; P = 0.005), as well as a 0 M to 2 M reduction in absolute volume overload (-1.08 ± 0.33 L; P = 0.025). However, there were no significant changes in serum or tissue sodium (all P > 0.05).
DISCUSSION
Low-sodium, home-meal delivery appears to be an effective method for improving volume control and blood pressure in HD patients. Future studies with larger sample sizes are needed to examine the long-term effects of home-delivered meals on these outcomes and to assess cost-effectiveness.",2020,"The low-sodium meal intervention significantly reduced IDWG when compared to the control period (-0.82 ± 0.14 kg; 95% confidence interval, -0.55 to -1.08 kg; P < 0.001).","['Twenty HD patients (55\u2009±\u200912\u2009years, body mass index [BMI] 40.7\u2009±\u200916.6', 'HD patients', 'hemodialysis patients', 'Patients with kidney failure undergoing maintenance hemodialysis (HD) therapy']","['low-sodium, home-delivered meals', 'low-sodium, home-delivered meals in HD patients']","['DBP', 'IDWG', 'interdialytic weight gain', 'blood pressure', 'changes in dietary sodium intake, thirst, xerostomia, blood pressure, volume overload, and muscle sodium concentration', 'interdialytic weight gain (IDWG', 'xerostomia score', 'IDWG, hydration status (bioimpedance), standardized blood pressure (BP), food intake (3-day dietary recall), and muscle sodium (magnetic resonance imaging) at baseline (0\u2009M', 'dietary sodium intake', 'serum or tissue sodium', 'SBP']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}]",20.0,0.0130782,"The low-sodium meal intervention significantly reduced IDWG when compared to the control period (-0.82 ± 0.14 kg; 95% confidence interval, -0.55 to -1.08 kg; P < 0.001).","[{'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Perez', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Hsin-Yu', 'Initials': 'HY', 'LastName': 'Fang', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Sadia-Anjum', 'Initials': 'SA', 'LastName': 'Ashrafi', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Burrows', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Alexis C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Larsen', 'Affiliation': 'Beckman Institute, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Bradley P', 'Initials': 'BP', 'LastName': 'Sutton', 'Affiliation': 'Beckman Institute, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Wilund', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12902']
2024,33150703,Intrathecal autologous bone marrow stem cell therapy in children with autism: A randomized controlled trial.,"INTRODUCTION
This study aimed to determine the safety and efficacy of treatment with autologous bone marrow mesenchymal stem cell (BMMSCs) compared with the routine treatment in children with autism spectrum disorder (ASD).
METHODS
In this ethically approved randomized controlled trial, 32 ASD children aged 5-15 years were randomly assigned to receive either autologous BMMSC plus rehabilitation therapy and risperidone (intervention group) or rehabilitation therapy and risperidone (control group). Autologous BMMSCs were intrathecally injected in the intervention group twice in 4 weeks. Patients were assessed using childhood autism rating scale (CARS), Gilliam autism rating scale-second edition (GARS-II), and clinical global impression (CGI) at the baseline, as well as 6 and 12 months after intervention.
RESULTS
Overall, 32 patients in two groups of intervention (n = 14) and control (n = 18) completed the study, of which 27 (84.4%) were male. Mean age was 9.50 ± 2.14 years. The improvements in CARS total score, GARS-II autism index, and CGI global improvement showed no significant differences between the groups over 12 months. However, the main effect for time*group interaction was significant regarding the CGI-severity of illness, showing a significantly more pronounced improvement in the intervention group (F = 6.719; P = .002).
DISCUSSION
Intrathecal injection of autologous BMMSCs seems to be safe and feasible, but has limited clinical efficacy in treatment of children with ASD.",2020,"The improvements in CARS total score, GARS-II autism index, and CGI global improvement showed no significant differences between the groups over 12 months.","['children with autism spectrum disorder (ASD', 'children with autism', '32 ASD children aged 5-15\u2009years', 'children with ASD', 'Mean age was 9.50\u2009±\u20092.14\u2009years', '32 patients in two groups of intervention (n = 14) and control (n = 18) completed the study, of which 27 (84.4%) were male']","['autologous BMMSC plus rehabilitation therapy and risperidone (intervention group) or rehabilitation therapy and risperidone (control group', 'autologous bone marrow mesenchymal stem cell (BMMSCs', 'Autologous BMMSCs', 'Intrathecal autologous bone marrow stem cell therapy']","['CARS total score, GARS-II autism index, and CGI global improvement', 'safety and efficacy', 'childhood autism rating scale (CARS), Gilliam autism rating scale-second edition (GARS-II), and clinical global impression (CGI', 'CGI-severity of illness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4704952', 'cui_str': 'Bone Marrow Mesenchymal Stem Cells'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0872278', 'cui_str': 'Stem cell therapy'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]",32.0,0.0453491,"The improvements in CARS total score, GARS-II autism index, and CGI global improvement showed no significant differences between the groups over 12 months.","[{'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Sharifzadeh', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghasemi', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Dr Sheikh Pediatric Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Tavakol Afshari', 'Affiliation': 'Immunology Research Center, Avicenna Research Institute, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Moharari', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Soltanifar', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Talaei', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Pouryousof', 'Affiliation': 'General Directorate of Welfare, State Welfare Organization of Razavi Khorasan, Mashhad, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Nahidi', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Fayyazi Bordbar', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Ziaee', 'Affiliation': 'Department of Community Medicine, School of Medicine, Social Determinants of Health Research Center, Gonabad University of Medical Sciences, Gonabad, Iran.'}]",Asia-Pacific psychiatry : official journal of the Pacific Rim College of Psychiatrists,['10.1111/appy.12445']
2025,33150711,"Electrophysiologically Verified Effects of ACUpuncture on DIabetic Peripheral Neuropathy in Type 2 Diabetes: The Randomized, Partially Double-blinded, Controlled ACUDIN Trial.","BACKGROUND
Acupuncture is commonly used in Traditional Chinese Medicine for treatment of diabetic peripheral neuropathy (DPN), but data from randomized controlled trials are rare.
METHODS
This randomized, placebo-controlled, partially double-blinded clinical trial randomly assigned adults with confirmed type 2 diabetes-induced DPN to receive 10 sessions of needle acupuncture, laser acupuncture, or placebo laser acupuncture for 10 consecutive weeks. Treatment was provided at bilateral acupoints Ex-LE-10 (Bafeng), Ex-LE-12 (Qiduan), and ST-34 (Lianqiu). Neurological assessments, including nerve conduction studies (NCS) of sural and tibial nerves, were performed at baseline, weeks 6 and 15. Primary outcome was delta of sural sensory nerve action potential (SNAP). Secondary outcomes included further NCS values, clinical scores, and patient-reported outcome measures (PROMs).
RESULTS
Of 180 participants, 172 completed the study. Sural SNAP and sural and tibial nerve conduction velocities improved significantly after 10 treatments when comparing needle acupuncture to placebo. Needle acupuncture showed earlier onset of action than laser acupuncture. PROMs showed larger improvements following needle and laser acupuncture than placebo, reaching significant differences for hyperesthesia and cramps following needle acupuncture, and for heat sensation following laser acupuncture.
CONCLUSIONS
Classical needle acupuncture had significant effects on DPN. Improvement in NCS values presumably indicates structural neuroregeneration following acupuncture.",2020,"PROMs showed larger improvements following needle and laser acupuncture than placebo, reaching significant differences for hyperesthesia and cramps following needle acupuncture, and for heat sensation following laser acupuncture.
","['180 participants', 'diabetic peripheral neuropathy (DPN', 'Type 2 Diabetes', 'adults with confirmed type 2 diabetes-induced DPN to receive 10 sessions of']","['ACUpuncture', 'Acupuncture', 'Needle acupuncture', 'placebo', 'needle acupuncture, laser acupuncture, or placebo laser acupuncture', 'laser acupuncture']","['DPN', 'DIabetic Peripheral Neuropathy', 'Sural SNAP and sural and tibial nerve conduction velocities', 'NCS values, clinical scores, and patient-reported outcome measures (PROMs', 'Neurological assessments, including nerve conduction studies (NCS) of sural and tibial nerves', 'hyperesthesia and cramps', 'delta of sural sensory nerve action potential (SNAP']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0181956', 'cui_str': 'Acupuncture needle'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0394654', 'cui_str': 'Laser acupuncture'}]","[{'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0522219', 'cui_str': 'Sensory potential'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020453', 'cui_str': 'Hyperesthesia'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]",180.0,0.745425,"PROMs showed larger improvements following needle and laser acupuncture than placebo, reaching significant differences for hyperesthesia and cramps following needle acupuncture, and for heat sensation following laser acupuncture.
","[{'ForeName': 'Gesa', 'Initials': 'G', 'LastName': 'Meyer-Hamme', 'Affiliation': 'HanseMerkur Center for Traditional Chinese Medicine at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Friedemann', 'Affiliation': 'HanseMerkur Center for Traditional Chinese Medicine at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Greten', 'Affiliation': 'Heidelberg School of Chinese Medicine, Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gerloff', 'Affiliation': 'Department of Neurology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schroeder', 'Affiliation': 'HanseMerkur Center for Traditional Chinese Medicine at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Journal of diabetes,['10.1111/1753-0407.13130']
2026,33150799,Phase III study of selpercatinib vs chemotherapy +/- pembrolizumab in untreated RET positive non-small-cell lung cancer.,"Selpercatinib, a novel, highly selective and potent, inhibitor of RET , demonstrated clinically meaningful antitumor activity with manageable toxicity in heavily pretreated and treatment-naive RET fusion-positive non-small-cell lung cancer patients in a Phase I/II clinical trial. LIBRETTO-431 (NCT04194944) is a randomized, global, multicenter, open-label, Phase III trial, evaluating selpercatinib versus carboplatin or cisplatin and pemetrexed chemotherapy with or without pembrolizumab in treatment-naive patients with locally advanced/metastatic RET fusion-positive nonsquamous non-small-cell lung cancer. The primary end point is progression-free survival by independent review. Key secondary end points include overall survival, response rate, duration of response and progression-free survival. Clinical trial registration: NCT04194944 (ClinicalTrials.gov).",2020,"Selpercatinib, a novel, highly selective and potent, inhibitor of RET , demonstrated clinically meaningful antitumor activity with manageable toxicity in heavily pretreated and treatment-naive RET fusion-positive non-small-cell lung cancer patients in a Phase I/II clinical trial.",['treatment-naive patients with locally advanced/metastatic RET fusion-positive nonsquamous non-small-cell lung cancer'],"['selpercatinib vs chemotherapy ', 'pembrolizumab', 'selpercatinib versus carboplatin or cisplatin and pemetrexed chemotherapy with or without pembrolizumab']","['progression-free survival', 'overall survival, response rate, duration of response\xa0and progression-free survival']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.166224,"Selpercatinib, a novel, highly selective and potent, inhibitor of RET , demonstrated clinically meaningful antitumor activity with manageable toxicity in heavily pretreated and treatment-naive RET fusion-positive non-small-cell lung cancer patients in a Phase I/II clinical trial.","[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Solomon', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Cai Cun', 'Initials': 'CC', 'LastName': 'Zhou', 'Affiliation': 'Shanghai Pulmonary Hospital, Shanghai, China.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Drilon', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Manhattan, NY 10065, USA.'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': 'Center for Integrated Oncology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Elamin', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX\xa077030, USA.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Davis', 'Affiliation': 'Eli Lilly and\xa0Company, Indianapolis, IN\xa046225, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Soldatenkova', 'Affiliation': 'Eli Lilly and\xa0Company, Indianapolis, IN\xa046225, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Sashegyi', 'Affiliation': 'Eli Lilly and\xa0Company, Indianapolis, IN\xa046225, USA.'}, {'ForeName': 'Aimee Bence', 'Initials': 'AB', 'LastName': 'Lin', 'Affiliation': 'Eli Lilly and\xa0Company, Indianapolis, IN\xa046225, USA.'}, {'ForeName': 'Boris K', 'Initials': 'BK', 'LastName': 'Lin', 'Affiliation': 'Eli Lilly and\xa0Company, Indianapolis, IN\xa046225, USA.'}, {'ForeName': 'Herbert H', 'Initials': 'HH', 'LastName': 'F Loong', 'Affiliation': 'The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'Department of Oncology, AOU San Luigi-Orbassano, University of Turin, Italy.'}, {'ForeName': 'Edurne', 'Initials': 'E', 'LastName': 'Arriola', 'Affiliation': 'Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Pérol', 'Affiliation': 'Léon Bérard Cancer Center of Lyon, Lyon, France.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Fernando C', 'Initials': 'FC', 'LastName': 'Santini', 'Affiliation': 'Oncology Center, Hospital Sírio Libanês, Sao Paulo, Brazil.'}]","Future oncology (London, England)",['10.2217/fon-2020-0935']
2027,33150816,"Improved Executive Function in Adults Diagnosed With Attention-Deficit/ Hyperactivity Disorder as Measured by the Brown Attention-Deficit Disorder Scale Following Treatment With SHP465 Mixed Amphetamine Salts Extended-Release: Post Hoc Analyses From 2 Randomized, Placebo-Controlled Studies.","OBJECTIVE
Assess executive function (EF) improvement with SHP465 mixed amphetamine salts (MAS) extended-release in adults with attention-deficit/hyperactivity disorder (ADHD) using responder analyses of the Brown Attention-Deficit Disorder Scale (BADDS).
METHODS
Post hoc analyses examined data from placebo-controlled SHP465 MAS dose-optimization (12.5-75 mg) and fixed-dose (25-75 mg) studies. Treatment response was assessed using two definitions (BADDS total score at endpoint <50 [no EF impairment] vs. ≥50 [impaired]; BADDS total score at endpoint relative to the in-treatment 90% CI range for baseline total score [below the range = improved]).
RESULTS
Response rates (SHP465 MAS vs. placebo) favored SHP465 MAS (all nominal p < .0001) in the dose-optimization (BADDS <50: 41.9% vs. 19.2%; below 90% CI range: 57.4% vs. 29.6%) and fixed-dose (BADDS <50: 51.9% vs. 16.7%; below 90% CI range: 70.6% vs. 32.3%) studies.
CONCLUSION
Improvement in EF measured by BADDS response rates was approximately 2-fold greater with SHP465 MAS than placebo.",2020,"RESULTS
Response rates (SHP465 MAS vs. placebo) favored SHP465 MAS (all nominal p < .0001) in the dose-optimization (BADDS","['adults with attention-deficit/hyperactivity disorder (ADHD', 'Adults Diagnosed With Attention-Deficit/ Hyperactivity Disorder']","['SHP465 mixed amphetamine salts (MAS', 'SHP465 Mixed Amphetamine Salts', 'placebo', 'placebo-controlled SHP465 MAS dose-optimization', 'Placebo', 'optimization (BADDS']","['fixed-dose (BADDS', 'BADDS response rates', 'Executive Function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.311947,"RESULTS
Response rates (SHP465 MAS vs. placebo) favored SHP465 MAS (all nominal p < .0001) in the dose-optimization (BADDS","[{'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Brown', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, and Brown Clinic for Attention & Related Disorders, Manhattan Beach, CA, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Takeda Pharmaceuticals, Lexington, MA, USA.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Robertson', 'Affiliation': 'Shire, a member of the Takeda group of companies, Lexington, MA, USA.'}]",Journal of attention disorders,['10.1177/1087054720961819']
2028,33150811,Effectiveness of an Educational Intervention to Increase Human Papillomavirus Knowledge and Attitude in Staff and Nursing Students.,"PURPOSE
To evaluate the effect of education about human papilloma virus and its vaccine on awareness and attitude of healthcare workers and nursing students.
DESIGN
This was a quasi-experimental study.
METHODS
The sample size was 250 (155 healthcare workers and 95 students), and both groups received educational intervention. Questionnaires were used to collect data before, after, and also 3 months following the intervention.
FINDINGS
The mean age of participants was 30.1 ± 10.23 years. Results showed a significant increase in knowledge ( P < .001), overall attitude ( P = .000), and perceived behavior ( P < .001) of the participants after the educational intervention.
CONCLUSION
Educational intervention was effective in knowledge, attitude, and behavior of students and healthcare workers.
CLINICAL EVIDENCE
Educational intervention can be one of the strategies to prevent individuals from acquiring the virus and to increase vaccine compliance.",2020,"Results showed a significant increase in knowledge ( P < .001), overall attitude ( P = .000), and perceived behavior ( P < .001) of the participants after the educational intervention.
","['Staff and Nursing Students', 'healthcare workers and nursing students', 'The mean age of participants was 30.1\xa0±\xa010.23\xa0years', 'sample size was 250 (155 healthcare workers and 95 students']","['educational intervention', 'education about human papilloma virus and its vaccine', 'Educational intervention', 'Educational Intervention']","['knowledge', 'overall attitude', 'perceived behavior']","[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0409019,"Results showed a significant increase in knowledge ( P < .001), overall attitude ( P = .000), and perceived behavior ( P < .001) of the participants after the educational intervention.
","[{'ForeName': 'Camellia', 'Initials': 'C', 'LastName': 'Torabizadeh', 'Affiliation': 'Community Based Psychiatric Care Research Center, Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences , Shiraz, Iran.'}, {'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Nick', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences , Shiraz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Vizeshfar', 'Affiliation': 'Nursing Department, School of Nursing and Midwifery, Community Based Psychiatric Care Research Center, Shiraz University of Medical Sciences , Shiraz, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Jamalimoghadam', 'Affiliation': 'Nursing Department, School of Nursing and Midwifery, Shiraz University of Medical Sciences , Shiraz, Iran.'}, {'ForeName': 'Shahpar', 'Initials': 'S', 'LastName': 'Bagheri', 'Affiliation': 'Community Based Psychiatric Care Research Center, Shiraz University of Medical Sciences , Shiraz, Iran.'}]",Journal of community health nursing,['10.1080/07370016.2020.1809857']
2029,33150817,Intramedullary hemostasis further reduces postoperative anemia in patients over 70 years old undergoing total hip arthroplasty.,"PURPOSE
Postoperative anemia has been a threat to total hip arthroplasty patients. We introduced a novel medullary cavity hemostasis (MCH) technique and combined it with tranexamic acid (TXA) to prevent postoperative anemia in elder patients. This trial was conducted to evaluate the effectiveness and safety of this technique.
METHODS
In this retrospective consecutive study, each group has 88 patients who were all over 70 years old. In the control group, patients were given TXA. In the experimental group, the MCH technique and same TXA application were used.
RESULTS
The average of total blood loss, drainage volume, and hidden blood loss were significantly less in the experimental group. The postoperative hemoglobin (Hb) level was significantly higher in the experimental group (100.6 g/dL) than it is in the control group (81.4 g/dL). None of the patient has shown signs of prosthesis subsidence, periprosthetical osteolysis, or stem loosening during follow-ups in the average follow-up time of 3 years.
CONCLUSION
We discovered that application of TXA alone is not sufficient to prevent postoperative moderate anemia in patients over 70 years old. Combination of TXA and MCH is an effective and safe way to alleviate the severity of postoperative anemia.",2020,"None of the patient has shown signs of prosthesis subsidence, periprosthetical osteolysis, or stem loosening during follow-ups in the average follow-up time of 3 years.
","['patients over 70 years old', 'elder patients', 'total hip arthroplasty patients', '88 patients who were all over 70 years old', 'patients over 70 years old undergoing total hip arthroplasty']","['TXA and MCH', 'TXA', 'Intramedullary hemostasis', 'novel medullary cavity hemostasis (MCH) technique and combined it with tranexamic acid (TXA']","['postoperative hemoglobin (Hb) level', 'effectiveness and safety', 'postoperative anemia', 'postoperative moderate anemia', 'average of total blood loss, drainage volume, and hidden blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0222662', 'cui_str': 'Medullary cavity of bone'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205262', 'cui_str': 'Occult'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",88.0,0.0201606,"None of the patient has shown signs of prosthesis subsidence, periprosthetical osteolysis, or stem loosening during follow-ups in the average follow-up time of 3 years.
","[{'ForeName': 'Kaying', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Department of Orthopaedics, 159411Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yahong', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopaedics, 159411Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Mu', 'Affiliation': 'Department of Orthopaedics, 159411Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Ruidong', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, 159411Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Nie', 'Affiliation': 'Department of Orthopaedics, 159411Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Liangjun', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Department of Orthopaedics, 159411Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499020965624']
2030,33151286,Effect of Taxane Chemotherapy With or Without Indoximod in Metastatic Breast Cancer: A Randomized Clinical Trial.,"Importance
Indoleamine 2,3-dioxygenase 1 (IDO1) causes tumor immune suppression. The IDO1 pathway inhibitor indoximod combined with a taxane in patients with ERBB2-negative metastatic breast cancer was tested in a prospective clinical trial.
Objective
To assess clinical outcomes in patients with ERBB2-negative metastatic breast cancer treated with indoximod plus a taxane.
Design, Setting, and Participants
This phase 2 double-blinded randomized 1:1 placebo-controlled clinical trial enrolled patients at multiple international centers from August 26, 2013, to January 25, 2016. Eligibility criteria included ERBB2-negative metastatic breast cancer, ability to receive taxane therapy, good performance status, normal organ function, no previous immunotherapy use, and no autoimmune disease. The study was discontinued in June 2017 because of lack of efficacy. Data analysis was performed from February 2019 to April 2020.
Interventions
A taxane (paclitaxel [80 mg/m2] weekly 3 weeks on, 1 week off, or docetaxel [75 mg/m2] every 3 weeks) plus placebo or indoximod (1200 mg) orally twice daily as first-line treatment.
Main Outcomes and Measures
The primary end point was progression-free survival (PFS); secondary end points were median overall survival, objective response rate, and toxic effects. A sample size of 154 patients would detect a hazard ratio of 0.64 with 1-sided α = .1 and β = .2 after 95 events. Archival tumor tissue was stained with immunohistochemistry for IDO1 expression as an exploratory analysis.
Results
Of 209 patients enrolled, 169 were randomized and 164 were treated (85 in the indoximod arm; 79 in the placebo arm). The median (range) age was 58 (29-85) years; 166 (98.2%) were female, and 135 (79.9%) were White. The objective response rate was 40% and 37%, respectively (indoximod vs placebo) (P = .74). The median (range) follow-up time was 17.4 (0.1-39.4) months. The median PFS was 6.8 months (95% CI, 4.8-8.9) in the indoximod arm and 9.5 months (95% CI, 7.8-11.2) in the placebo arm (hazard ratio, 1.2; 95% CI, 0.8-1.8). Differences between the experimental and placebo arms in median PFS (6.8 vs 9.5 months) and overall survival (19.5 vs 20.6 months) were not statistically significant. Grade 3 or greater treatment-emergent adverse events occurred in 60% of patients in both arms.
Conclusions and Relevance
This randomized clinical trial found that, among patients with ERBB2-negative metastatic breast cancer, addition of indoximod to a taxane did not improve PFS compared with a taxane alone.
Trial Registration
ClinicalTrials.gov Identifier: NCT01792050.",2020,"The objective response rate was 40% and 37%, respectively (indoximod vs placebo)","['patients with ERBB2-negative metastatic breast cancer', 'The median (range) age was 58 (29-85) years; 166 (98.2%) were female, and 135 (79.9%) were White', 'patients with ERBB2-negative metastatic breast cancer treated with', 'Metastatic Breast Cancer', 'enrolled patients at multiple international centers from August 26, 2013, to January 25, 2016', '209 patients enrolled, 169 were randomized and 164 were treated (85 in the indoximod arm; 79 in the placebo arm']","['placebo or indoximod', 'indoximod vs placebo', 'Taxane Chemotherapy With or Without Indoximod', 'taxane (paclitaxel', 'placebo', 'taxane', 'Indoleamine 2,3-dioxygenase 1', 'taxane therapy', 'docetaxel', 'indoximod plus a taxane']","['median overall survival, objective response rate, and toxic effects', 'progression-free survival (PFS', 'Grade 3 or greater treatment-emergent adverse events', 'objective response rate', 'overall survival', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0041256', 'cui_str': 'Tryptophan 2,3-dioxygenase'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",209.0,0.691952,"The objective response rate was 40% and 37%, respectively (indoximod vs placebo)","[{'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Mariotti', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}, {'ForeName': 'Hyo', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}, {'ForeName': 'Roohi', 'Initials': 'R', 'LastName': 'Ismail-Khan', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}, {'ForeName': 'Shou Jiang', 'Initials': 'SJ', 'LastName': 'Tang', 'Affiliation': 'University of Mississippi Cancer Center and Research Institute, Jackson.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dillon', 'Affiliation': 'University of Virginia, Charlottesville.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Montero', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Poklepovic', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Melin', 'Affiliation': 'Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Nuhad K', 'Initials': 'NK', 'LastName': 'Ibrahim', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Kennedy', 'Affiliation': 'NewLink Genetics Corporation, Ames, Iowa.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Vahanian', 'Affiliation': 'NewLink Genetics Corporation, Ames, Iowa.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Link', 'Affiliation': 'NewLink Genetics Corporation, Ames, Iowa.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Tennant', 'Affiliation': 'NewLink Genetics Corporation, Ames, Iowa.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Schuster', 'Affiliation': 'NewLink Genetics Corporation, Ames, Iowa.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'NewLink Genetics Corporation, Ames, Iowa.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Danciu', 'Affiliation': 'University of Illinois at Chicago.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gilman', 'Affiliation': 'Lankenau Institute for Medical Research, Wynnewood, Pennsylvania.'}, {'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Soliman', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}]",JAMA oncology,['10.1001/jamaoncol.2020.5572']
2031,33151313,Association of Serum Neurofilament Light Levels With Long-term Brain Atrophy in Patients With a First Multiple Sclerosis Episode.,"Importance
Data are needed on the potential long-term prognostic association of serum neurofilament light in multiple sclerosis (MS).
Objective
To evaluate serum neurofilament light as a biomarker associated with long-term disease outcomes in clinically isolated syndrome.
Design, Setting, and Participants
This post hoc cohort study used data from the Controlled High-Risk Avonex Multiple Sclerosis Prevention Study, a 36-month, multicenter, placebo-controlled interferon β-1a randomized clinical trial conducted from April 1996 to March 2000, and its long-term (5- and 10-year) extension study from February 2001 to March 2009. Participants included individuals with a symptomatic initial demyelinating event and brain magnetic resonance imaging (MRI) lesions suggestive of MS. Data were analyzed from April 2017 through 2019.
Exposure
The variable of interest was naturally occurring serum neurofilament light concentration.
Main Outcomes and Measures
Gadolinium-enhancing (Gd+) lesion number, T2 lesion volume, and brain parenchymal fraction, a measure of brain atrophy were measured at baseline and 5 and 10 years. Multivariate regression models evaluated whether age, sex, and baseline covariates, including serum neurofilament light, brain parenchymal fraction, Expanded Disability Status Scale, Gd+ lesion count, and T2 lesion volume, were associated with brain parenchymal fraction changes over 5 and 10 years.
Results
Among 308 included participants (mean [SD] age, 33.2 [7.6] years; 234 [76.0%] women), baseline serum neurofilament light concentrations were associated with Gd+ lesions (Spearman r = 0.41; P < .001) and T2 lesion volume (Spearman r = 0.42; P < .001). Among covariates for brain parenchymal fraction change, serum neurofilament light concentration had the greatest correlation with change in brain parenchymal fraction at 5 years (Spearman r = -0.38; P < .001) and was the only variable associated with brain parenchymal fraction at 10 years (Spearman r = -0.45; P < .001). Participants in the highest vs lowest baseline serum neurofilament light tertiles showed brain parenchymal fraction reduction at 5 years (-1.83% [95% CI, -1.49% to -2.18%] vs -0.95% [95% CI, -0.78% to -1.12%]; P < .001) and 10 years (-3.54% [95% CI, -2.90% to -4.17%] vs -1.90% [95% CI, -1.43% to -2.37%]; P < .001). At 5 years, 6 of 45 participants (13.3%) in the highest neurofilament tertile and 2 of 52 participants (3.8%) in the lowest neurofilament tertile achieved an Expanded Disability Status Scale score of 3.5 or greater.
Conclusions and Relevance
This cohort study found that higher baseline serum neurofilament light levels were associated with increased brain atrophy over 5 and 10 years. These findings suggest that serum neurofilament light could be a biomarker associated with disease severity stratification in early MS and may help to guide intervention.",2020,"Among covariates for brain parenchymal fraction change, serum neurofilament light concentration had the greatest correlation with change in brain parenchymal fraction at 5 years (Spearman r ","['April 1996 to March 2000, and its long-term (5- and 10-year) extension study from February 2001 to March 2009', 'Participants included individuals with a symptomatic initial demyelinating event and brain magnetic resonance imaging (MRI) lesions suggestive of MS', 'clinically isolated syndrome', '308 included participants (mean [SD] age, 33.2 [7.6] years; 234 [76.0%] women', 'Patients With a First Multiple Sclerosis Episode']",['placebo'],"['brain parenchymal fraction changes', 'brain parenchymal fraction', 'brain parenchymal fraction reduction', 'T2 lesion volume', 'brain atrophy', 'brain parenchymal fraction change, serum neurofilament light concentration', 'Measures\n\n\nGadolinium-enhancing (Gd+) lesion number, T2 lesion volume, and brain parenchymal fraction, a measure of brain atrophy', 'serum neurofilament light, brain parenchymal fraction, Expanded Disability Status Scale, Gd+ lesion count, and T2 lesion volume', 'Expanded Disability Status Scale score', 'baseline serum neurofilament light concentrations']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C2921627', 'cui_str': 'Clinically isolated syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0449791', 'cui_str': 'Number of lesions'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",308.0,0.0379221,"Among covariates for brain parenchymal fraction change, serum neurofilament light concentration had the greatest correlation with change in brain parenchymal fraction at 5 years (Spearman r ","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Plavina', 'Affiliation': 'Biogen, Cambridge, Massachusetts.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Singh', 'Affiliation': 'Biogen, Cambridge, Massachusetts.'}, {'ForeName': 'Dipen', 'Initials': 'D', 'LastName': 'Sangurdekar', 'Affiliation': 'Biogen, Cambridge, Massachusetts.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'de Moor', 'Affiliation': 'Biogen, Cambridge, Massachusetts.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Engle', 'Affiliation': 'Biogen, Cambridge, Massachusetts.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Gafson', 'Affiliation': 'Biogen, Cambridge, Massachusetts.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Goyal', 'Affiliation': 'Biogen, Cambridge, Massachusetts.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Fisher', 'Affiliation': 'Biogen, Cambridge, Massachusetts.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Szak', 'Affiliation': 'Biogen, Cambridge, Massachusetts.'}, {'ForeName': 'Revere P', 'Initials': 'RP', 'LastName': 'Kinkel', 'Affiliation': 'Department of Neurosciences, University of California, San Diego.'}, {'ForeName': 'Alfred W', 'Initials': 'AW', 'LastName': 'Sandrock', 'Affiliation': 'Biogen, Cambridge, Massachusetts.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Su', 'Affiliation': 'Biogen, Cambridge, Massachusetts.'}, {'ForeName': 'Bernd C', 'Initials': 'BC', 'LastName': 'Kieseier', 'Affiliation': 'Biogen, Cambridge, Massachusetts.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Rudick', 'Affiliation': 'Biogen, Cambridge, Massachusetts.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.16278']
2032,33151321,"Intense Simulation-Based Surgical Education for Manual Small-Incision Cataract Surgery: The Ophthalmic Learning and Improvement Initiative in Cataract Surgery Randomized Clinical Trial in Kenya, Tanzania, Uganda, and Zimbabwe.","Importance
Cataracts account for 40% of cases of blindness globally, with surgery the only treatment.
Objective
To determine whether adding simulation-based cataract surgical training to conventional training results in improved acquisition of surgical skills among trainees.
Design, Setting, and Participants
A multicenter, investigator-masked, parallel-group, randomized clinical educational-intervention trial was conducted at 5 university hospital training institutions in Kenya, Tanzania, Uganda, and Zimbabwe from October 1, 2017, to September 30, 2019, with a follow-up of 15 months. Fifty-two trainee ophthalmologists were assessed for eligibility (required no prior cataract surgery as primary surgeon); 50 were recruited and randomized. Those assessing outcomes of surgical competency were masked to group assignment. Analysis was performed on an intention-to-treat basis.
Interventions
The intervention group received a 5-day simulation-based cataract surgical training course, in addition to standard surgical training. The control group received standard training only, without a placebo intervention; however, those in the control group received the intervention training after the initial 12-month follow-up period.
Main Outcomes and Measures
The primary outcome measure was overall surgical competency at 3 months, which was assessed with a validated competency assessment rubric. Secondary outcomes included surgical competence at 1 year and quantity and outcomes (including visual acuity and posterior capsule rupture) of cataract surgical procedures performed during a 1-year period.
Results
Among the 50 participants (26 women [52.0%]; mean [SD] age, 32.3 [4.6] years), 25 were randomized to the intervention group, and 25 were randomized to the control group, with 1 dropout. Forty-nine participants were included in the final intention-to-treat analysis. Baseline characteristics were balanced. The participants in the intervention group had higher scores at 3 months compared with the participants in the control group, after adjusting for baseline assessment rubric score. The participants in the intervention group were estimated to have scores 16.6 points (out of 40) higher (95% CI, 14.4-18.7; P < .001) at 3 months than the participants in the control group. The participants in the intervention group performed a mean of 21.5 cataract surgical procedures in the year after the training, while the participants in the control group performed a mean of 8.5 cataract surgical procedures (mean difference, 13.0; 95% CI, 3.9-22.2; P < .001). Posterior capsule rupture rates (an important complication) were 7.8% (42 of 537) for the intervention group and 26.6% (54 of 203) for the control group (difference, 18.8%; 95% CI, 12.3%-25.3%; P < .001).
Conclusions and Relevance
This randomized clinical trial provides evidence that intense simulation-based cataract surgical education facilitates the rapid acquisition of surgical competence and maximizes patient safety.
Trial Registration
Pan-African Clinical Trial Registry, number PACTR201803002159198.",2020,"Posterior capsule rupture rates (an important complication) were 7.8% (42 of 537) for the intervention group and 26.6% (54 of 203) for the control group (difference, 18.8%; 95% CI, 12.3%-25.3%; P < .001).
","['Fifty-two trainee ophthalmologists were assessed for eligibility (required no prior cataract surgery as primary surgeon); 50 were recruited and randomized', '50 participants (26 women [52.0%]; mean [SD] age, 32.3 [4.6] years', 'trainees', 'Forty-nine participants were included in the final intention-to-treat analysis']","['standard training only, without a placebo intervention', 'Intense Simulation-Based Surgical Education for Manual Small-Incision Cataract Surgery', '5-day simulation-based cataract surgical training course, in addition to standard surgical training', 'intervention training', 'simulation-based cataract surgical training to conventional training']","['surgical competence at 1 year and quantity and outcomes (including visual acuity and posterior capsule rupture) of cataract surgical procedures performed during a 1-year period', 'overall surgical competency', 'Posterior capsule rupture rates', 'acquisition of surgical skills']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C1704292', 'cui_str': 'Ophthalmologist'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1535895', 'cui_str': 'Posterior capsule rupture'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",49.0,0.223161,"Posterior capsule rupture rates (an important complication) were 7.8% (42 of 537) for the intervention group and 26.6% (54 of 203) for the control group (difference, 18.8%; 95% CI, 12.3%-25.3%; P < .001).
","[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Dean', 'Affiliation': 'International Centre for Eye Health, Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gichuhi', 'Affiliation': 'Department of Ophthalmology, University of Nairobi, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Buchan', 'Affiliation': 'International Centre for Eye Health, Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Makupa', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Agrippa', 'Initials': 'A', 'LastName': 'Mukome', 'Affiliation': 'Department of Ophthalmology, Parirenyatwa Hospitals, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Otiti-Sengeri', 'Affiliation': 'Department of Ophthalmology, Makerere University School of Medicine, Kampala, Uganda.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Arunga', 'Affiliation': 'International Centre for Eye Health, Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Subhashis', 'Initials': 'S', 'LastName': 'Mukherjee', 'Affiliation': 'Bristol Eye Hospital, Bristol, United Kingdom.'}, {'ForeName': 'Min J', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Tropical Epidemiology Group, Faculty of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Harrison-Williams', 'Affiliation': 'Makeni Regional Hospital, Bombali, Sierra Leone.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'MacLeod', 'Affiliation': 'Tropical Epidemiology Group, Faculty of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Division of Ophthalmology, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Burton', 'Affiliation': 'International Centre for Eye Health, Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.4718']
2033,33151330,Cost-effectiveness of digital CBT (Sleepio) for insomnia: A Markov simulation model in the United States.,"STUDY OBJECTIVES
To examine the cost-effectiveness and potential net monetary benefit of a fully automated digital cognitive behavioral therapy (CBT) intervention for insomnia compared with no insomnia treatment in the United States (US). Similar relative comparisons were made for pharmacotherapy and clinician-delivered CBT (individual and group).
METHODS
We simulated a Markov model of 100,000 individuals using parameters calibrated from the literature including direct (treatment) and indirect costs (e.g., insomnia-related healthcare expenditure, lost workplace productivity). Health utility estimates were converted into quality-adjusted life years (QALYs) and one QALY was worth $50,000. Simulated individuals were randomized equally to one of five arms (digital CBT, pharmacotherapy, individual CBT, group CBT or no insomnia treatment). Sensitivity was assessed by bootstrapping the calibrated parameters. Cost estimates were expressed in 2019 US dollars.
RESULTS
Digital CBT was cost-beneficial when compared with no insomnia treatment and had a positive net monetary benefit of $681.06 (per individual over 6-months). Bootstrap sensitivity analysis demonstrated that the net monetary benefit was positive in 94.7% of simulations. Relative to other insomnia treatments, digital CBT was the most cost-effective treatment because it generated the smallest incremental cost-effectiveness ratio (-$3,124.73).
CONCLUSIONS
Digital CBT was the most cost-effective insomnia treatment followed by group CBT, pharmacotherapy, and individual CBT. It is financially prudent and beneficial from a societal perspective to utilize automated digital CBT to treat insomnia at a population scale.",2020,"RESULTS
Digital CBT was cost-beneficial when compared with no insomnia treatment and had a positive net monetary benefit of $681.06 (per individual over 6-months).","['insomnia', 'insomnia compared with no insomnia treatment in the United States (US']","['digital CBT (Sleepio', 'fully automated digital cognitive behavioral therapy (CBT) intervention', 'CBT, pharmacotherapy, individual CBT, group CBT or no insomnia treatment']","['Cost estimates', 'cost-effectiveness', 'Sensitivity']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",100000.0,0.0263307,"RESULTS
Digital CBT was cost-beneficial when compared with no insomnia treatment and had a positive net monetary benefit of $681.06 (per individual over 6-months).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Darden', 'Affiliation': 'Carey Business School, Johns Hopkins University, USA.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Big Health Inc., San Francisco, USA & London, UK.'}, {'ForeName': 'Jenna R', 'Initials': 'JR', 'LastName': 'Carl', 'Affiliation': 'Big Health Inc., San Francisco, USA & London, UK.'}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Big Health Inc., San Francisco, USA & London, UK.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Kanady', 'Affiliation': 'Big Health Inc., San Francisco, USA & London, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, University of California San Francisco School of Medicine, San Francisco, CA, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Miller', 'Affiliation': 'Big Health Inc., San Francisco, USA & London, UK.'}]",Sleep,['10.1093/sleep/zsaa223']
2034,33149729,A Randomized Trial Comparing Short versus Prolonged Hemostasis with Rescue Recanalization by Ipsilateral Ulnar Artery Compression: Impact on Radial Artery Occlusion-The RESCUE-RAO Trial.,"Background
Despite the enormous benefits of radial access, this route is associated with a risk of radial artery occlusion (RAO).
Objective
We compared the incidence of RAO in patients undergoing transradial coronary angiography and intervention after short versus prolonged hemostasis protocol. Also we assessed the efficacy of rescue 1-hour ipsilateral ulnar artery compression if RAO was observed after hemostasis. Material and Methods . Patients referred for elective transradial coronary procedures were eligible. After 6 F radial sheath removal, patients were randomized to short (3 hours) ( n = 495) or prolonged (8 hours) ( n = 503) hemostasis and a simple bandage was placed over the puncture site. After hemostasis was completed, oximetry plethysmography was used to assess the patency of the radial artery.
Results
One thousand patients were randomized. Baseline characteristics were similar between both groups with average age 61.4 ± 9.4 years (71% male) and PCI performed on half of the patients. The RAO rate immediately after hemostasis was 3.2% in the short hemostasis group and 10.1% in the prolonged group ( p < 0.001). Rescue recanalization was successful only in the short group in 56.2% (11/19); at hospital discharge, RAO rates were 1.4% in the short group and 10.1% in the prolonged group ( p < 0.001).
Conclusion
Shorter hemostasis was associated with significantly less RAO compared to prolonged hemostasis. Rescue radial artery recanalization was effective in > 50%, but only in the short hemostasis group.",2020,"Rescue recanalization was successful only in the short group in 56.2% (11/19); at hospital discharge, RAO rates were 1.4% in the short group and 10.1% in the prolonged group ( p < 0.001).
","['Patients referred for elective transradial coronary procedures were eligible', 'patients undergoing transradial coronary angiography and intervention after short versus prolonged hemostasis protocol']",['Prolonged Hemostasis with Rescue Recanalization by Ipsilateral Ulnar Artery Compression'],"['RAO rate immediately after hemostasis', 'Rescue recanalization', 'Rescue radial artery recanalization', 'RAO', 'hospital discharge, RAO rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0162858', 'cui_str': 'Structure of ulnar artery'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",1000.0,0.560317,"Rescue recanalization was successful only in the short group in 56.2% (11/19); at hospital discharge, RAO rates were 1.4% in the short group and 10.1% in the prolonged group ( p < 0.001).
","[{'ForeName': 'Dmitrii V', 'Initials': 'DV', 'LastName': 'Ognerubov', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sedaghat', 'Affiliation': 'Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Bonn, Germany.'}, {'ForeName': 'Sergey I', 'Initials': 'SI', 'LastName': 'Provatorov', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Andrey S', 'Initials': 'AS', 'LastName': 'Tereshchenko', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Olivier F', 'Initials': 'OF', 'LastName': 'Bertrand', 'Affiliation': 'Quebec Heart-Lung Institute, Quebec, Canada.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Bernat', 'Affiliation': 'University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic.'}, {'ForeName': 'Goar K', 'Initials': 'GK', 'LastName': 'Arutyunyan', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Olga A', 'Initials': 'OA', 'LastName': 'Pogorelova', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Tripoten', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Tatyana V', 'Initials': 'TV', 'LastName': 'Balakhonova', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Anatoliy N', 'Initials': 'AN', 'LastName': 'Samko', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'Evgeny V', 'Initials': 'EV', 'LastName': 'Merkulov', 'Affiliation': 'National Medical Research Center of Cardiology, Ministry of Health of Russia, Moscow, Russia.'}]",Journal of interventional cardiology,['10.1155/2020/7928961']
2035,33149768,MONARCH plus: abemaciclib plus endocrine therapy in women with HR+/HER2- advanced breast cancer: the multinational randomized phase III study.,"Aim
To compare the efficacy, safety, and tolerability of abemaciclib plus endocrine therapy (ET) versus ET alone in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC) from China, Brazil, India, and South Africa.
Methods
This randomized, double-blind, phase III study was conducted between 9 December 2016 and 29 March 2019. Postmenopausal women with HR-positive, HER2-negative ABC with no prior systemic therapy in an advanced setting (cohort A) or progression on prior ET (cohort B) received abemaciclib (150 mg twice daily) or placebo plus: anastrozole (1 mg/day) or letrozole (2.5 mg/day) (cohort A) or fulvestrant (500 mg per label) (cohort B). The primary endpoint was progression-free survival (PFS) in cohort A, analyzed using the stratified log-rank test. Secondary endpoints were PFS in cohort B (key secondary endpoint), objective response rate (ORR), and safety. This interim analysis was planned after 119 PFS events in cohort A.
Results
In cohort A, 207 patients were randomly assigned to the abemaciclib arm and 99 to the placebo arm. Abemaciclib significantly improved PFS versus placebo (median: not reached versus 14.7 months; hazard ratio 0.499; 95% confidence intervals (CI) 0.346-0.719; p = 0.0001). ORR was 65.9% in the abemaciclib arm and 36.1% in the placebo arm ( p < 0.0001, measurable disease population). In cohort B, 104 patients were randomly assigned to the abemaciclib arm and 53 to the placebo arm. Abemaciclib significantly improved PFS versus placebo (median: 11.5 versus 5.6 months; hazard ratio 0.376; 95% CI 0.240-0.588; p < 0.0001). ORR was 50.0% in the abemaciclib arm and 10.5% in the placebo arm ( p < 0.0001, measurable disease population). The most frequent grade ⩾3 adverse events in the abemaciclib arms were neutropenia, leukopenia, and anemia (both cohorts), and lymphocytopenia (cohort B).
Conclusion
The addition of abemaciclib to ET demonstrated significant and clinically meaningful improvement in PFS and ORR, without new safety signals observed in this population. Trial Registration: ClinicalTrials.gov identifier: NCT02763566.",2020,Abemaciclib significantly improved PFS versus placebo (median: not reached versus 14.7 months; hazard ratio 0.499; 95% confidence intervals (CI) 0.346-0.719; p = 0.0001).,"['postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC) from China, Brazil, India, and South Africa', 'Postmenopausal women with HR-positive, HER2-negative ABC with no prior systemic therapy in an advanced setting (cohort A) or progression on prior ET (cohort B) received', '207 patients', '104 patients', '9 December 2016 and 29 March 2019', 'women with HR+/HER2- advanced breast cancer']","['letrozole', 'MONARCH plus: abemaciclib plus endocrine therapy', 'placebo plus: anastrozole', 'abemaciclib plus endocrine therapy (ET) versus ET alone', 'placebo', 'abemaciclib', 'fulvestrant']","['efficacy, safety, and tolerability', 'neutropenia, leukopenia, and anemia (both cohorts), and lymphocytopenia (cohort B', 'ORR', 'PFS in cohort B (key secondary endpoint), objective response rate (ORR), and safety', 'PFS', 'progression-free survival (PFS']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",207.0,0.749121,Abemaciclib significantly improved PFS versus placebo (median: not reached versus 14.7 months; hazard ratio 0.499; 95% confidence intervals (CI) 0.346-0.719; p = 0.0001).,"[{'ForeName': 'Qing Yuan', 'Initials': 'QY', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University/ Liaoning Cancer Hospital, Shenyang, China.'}, {'ForeName': 'Yong Mei', 'Initials': 'YM', 'LastName': 'Yin', 'Affiliation': 'Department of Oncology, Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Hui Ping', 'Initials': 'HP', 'LastName': 'Li', 'Affiliation': 'Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': 'Department of Breast Disease, Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Zhong Sheng', 'Initials': 'ZS', 'LastName': 'Tong', 'Affiliation': 'Department of Breast Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Christina P', 'Initials': 'CP', 'LastName': 'Oppermann', 'Affiliation': 'Centro de Pesquisa Clínica de Oncologia e Hematologia, Hospital Mãe de Deus/AESC, Porto Alegre, Brazil.'}, {'ForeName': 'Yun Peng', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, First Affiliated Hospital of China Medical University,Shenyang, China.'}, {'ForeName': 'Romulo', 'Initials': 'R', 'LastName': 'Costa', 'Affiliation': 'Oncologia Clínica, Instituto do Cancer do Estado de São Paulo - ICESP, São Paulo, Brazil.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, Second Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Medical Thoracic Oncology, Jilin Provincial Cancer Hospital, Changchun, China.'}, {'ForeName': 'Qu Chang', 'Initials': 'QC', 'LastName': 'Ouyang', 'Affiliation': 'Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Liao', 'Affiliation': 'Department of Breast Cancer, Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Xin Hong', 'Initials': 'XH', 'LastName': 'Wu', 'Affiliation': 'Department of Breast Cancer, Hubei Cancer Hospital, Wuhan, China.'}, {'ForeName': 'Xiao Jia', 'Initials': 'XJ', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ji Feng', 'Initials': 'JF', 'LastName': 'Feng', 'Affiliation': 'Department of Medical Oncology, Jiangsu Province Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'Department of Gynecology and Obstetrics, Hospital Pérola Byington and FMUSP, São Paulo-SP, Brazil.'}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'Kanakasetty', 'Affiliation': 'Department of Medical Oncology, HCG Hospitals and Kidwai Memorial Institute of Oncology, Bangalore, India.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Coccia-Portugal', 'Affiliation': 'Clinical Trial Department, Eastleigh Breast Care Center, Pretoria, South Africa.'}, {'ForeName': 'Ru Bing', 'Initials': 'RB', 'LastName': 'Han', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States of America.'}, {'ForeName': 'Hai Dong', 'Initials': 'HD', 'LastName': 'Chi', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Ze Fei', 'Initials': 'ZF', 'LastName': 'Jiang', 'Affiliation': 'Department of Breast Cancer, Fifth Medical Center of Chinese PLA General Hospital, 100 West Fourth Ring Middle Road, Beijing 100071, China.'}, {'ForeName': 'Xi Chun', 'Initials': 'XC', 'LastName': 'Hu', 'Affiliation': ""Department of Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Shanghai 200032, China.""}]",Therapeutic advances in medical oncology,['10.1177/1758835920963925']
2036,33149779,Tricalcium phosphate and hydroxyapatite treatment for benign cavitary bone lesions: A prospective clinical trial.,"Benign bone tumors are surgically treated by curettage and by filling the defect using bone grafts or bone substitutes, such as hydroxyapatite crystals and tricalcium phosphate. The tricalcium phosphate mixed with hydroxyapatite, although fragile, is a good alternative with good integration. Fifteen patients with benign bone lesions were randomized in two groups surgically treated by curettage and filling of the bone defect using allograft (7 cases) or a mixture of 35% tricalcium phosphate, with 60-85% pore volume, and 65% hydroxyapatite (8 cases). After the surgery, all patients were followed up every 3 weeks until 6 months, and then at 2 months interval until one year for the clinical and radiological assessment. The average age was 35.4 years (from 18 to 54) for the allograft group and 41 years (from 22 to 58) for the patients treated with bone substitute. Eight patients were male and seven female, with relatively equal distribution between both groups. The average bone defect was relatively equal: 14 cc (4-25 cc) for the allograft group and 15.1 cc (4-33 cc) for the ceramic group (P>0.1). During the follow-up, all the lesions gradually disappeared after 12 months, with a time of healing of 18.8 weeks (15-24 weeks) for the allograft group and 20.37 weeks (15-28) for the bone substitute group. There were no significant differences regarding the clinical status and the radiological assessment after 12 months. No patient required extra pain medication after 2 weeks. No complications have been recorded. The surgical treatment of small and medium sized lytic benign tumors has good results with both types of graft that were studied. Using tricalcium phosphate mixed with hydroxyapatite as bone substitute represents a good and low cost alternative, but it is a relatively fragile material with a slower time to integrate compared to the allograft.",2020,No complications have been recorded.,"['benign cavitary bone lesions', 'Fifteen patients with benign bone lesions', 'Eight patients were male and seven female, with relatively equal distribution between both groups', 'The average age was 35.4 years (from 18 to 54) for the allograft group and 41 years (from 22 to 58) for the patients treated with bone substitute']","['Tricalcium phosphate and hydroxyapatite treatment', 'curettage and filling of the bone defect using allograft (7 cases) or a mixture of 35% tricalcium phosphate, with 60-85% pore volume, and 65% hydroxyapatite', 'tricalcium phosphate mixed with hydroxyapatite']","['extra pain medication', 'average bone defect']","[{'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0238792', 'cui_str': 'Bone lesion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0243003', 'cui_str': 'Bone Substitute'}]","[{'cui': 'C0108136', 'cui_str': 'tricalcium phosphate'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}]",15.0,0.0148341,No complications have been recorded.,"[{'ForeName': 'Şerban', 'Initials': 'Ş', 'LastName': 'Dragosloveanu', 'Affiliation': ""Department of Orthopedics, 'Carol Davila' University of Medicine and Pharmacy, 050474 Bucharest, Romania.""}, {'ForeName': 'Christiana D M', 'Initials': 'CDM', 'LastName': 'Dragosloveanu', 'Affiliation': ""Department of Ophthalmology, 'Carol Davila' University of Medicine and Pharmacy, 050474 Bucharest, Romania.""}, {'ForeName': 'Horia T', 'Initials': 'HT', 'LastName': 'Stanca', 'Affiliation': ""Department of Ophthalmology, 'Carol Davila' University of Medicine and Pharmacy, 050474 Bucharest, Romania.""}, {'ForeName': 'Dragoş C', 'Initials': 'DC', 'LastName': 'Cotor', 'Affiliation': ""Department of Orthopedic Surgery, 'Foisor' Orthopedics-Traumatology and Osteoarticular TB Hospital, 030167 Bucharest, Romania.""}, {'ForeName': 'Adrian C', 'Initials': 'AC', 'LastName': 'Andrei', 'Affiliation': ""Department of Orthopedic Surgery, 'Foisor' Orthopedics-Traumatology and Osteoarticular TB Hospital, 030167 Bucharest, Romania.""}, {'ForeName': 'Călin I', 'Initials': 'CI', 'LastName': 'Dragosloveanu', 'Affiliation': ""Department of Orthopedic Surgery, 'Foisor' Orthopedics-Traumatology and Osteoarticular TB Hospital, 030167 Bucharest, Romania.""}, {'ForeName': 'Cristian I', 'Initials': 'CI', 'LastName': 'Stoica', 'Affiliation': ""Department of Orthopedics, 'Carol Davila' University of Medicine and Pharmacy, 050474 Bucharest, Romania.""}]",Experimental and therapeutic medicine,['10.3892/etm.2020.9345']
2037,33149794,Clinical impact of a pharmacist-led medication review with follow up for aged polypharmacy patients: A cluster randomized controlled trial.,"Background
Medication review with follow-up (MRF) is a service where community pharmacists undertake a medication review with monthly follow-up to provide continuing care. The ConSIGUE Program assessed the impact and implementation of MRF for aged polypharmacy patients in Spanish Community Pharmacies. The present paper reports on the clinical impact evaluation phase of ConSIGUE.
Objective
The main objective of the study was to measure the effect of MRF on the primary outcome of the number of uncontrolled health problems. Secondary objectives were to analyze the drug-related problems (DRPs) identified as potential causes of ineffective or unsafe medications and the pharmacists' interventions implemented during MRF provision.
Methods
An open-label multi-centered cluster randomized study with comparison group (CG) was carried out in community pharmacies from 4 provinces in Spain during 6 months. The main inclusion criteria were patients over 64 years old, using 5 or more medicines. The intervention group (IG) received the MRF service (advanced medication review-type 3 MR) whereas patients in the CG received usual care.
Results
178 pharmacies recruited 1403 patients (IG= 688 patients; CG= 715 patients). During the 6 months of the study 72 patients were lost to follow up. The adjusted multi-level random effects models showed a significant reduction in the number of uncontrolled health problems over the periods in the IG (-0.72, 95% CI: -0.80, -0.65) and no change in the CG (-0.03, 95% CI: -0.10, 0.04). Main DRPs identified as potential causes of failures of uncontrolled health problems' treatment were undertreated condition (559 DRPs; 35.81%), lack of treatment adherence (261 DRP; 16.67%) and risk of adverse effects (207 DRPs; 13.53%). Interventions performed by pharmacist to solve DRP mainly included the addition (246 interventions; 14.67%) and change (330 interventions; 19.68%) of a medicine and educational interventions on medicine adherence (231 interventions; 13.78%) and non-pharmacological interventions (369 interventions; 22.01%).
Conclusions
This study provides evidence of the impact of community pharmacist on clinical outcomes for aged patients. It suggests that the provision of an MRF in collaboration with general medical practitioners and patients contributes to the improvement of aged polypharmacy patients' health status and reduces their problems related with the use of medicines.",2020,"The adjusted multi-level random effects models showed a significant reduction in the number of uncontrolled health problems over the periods in the IG (-0.72, 95% CI: -0.80, -0.65) and no change in the CG (-0.03, 95% CI: -0.10, 0.04).","['aged patients', 'community pharmacies from 4 provinces in Spain during 6 months', '178 pharmacies recruited 1403 patients (IG= 688 patients; CG= 715 patients', 'aged polypharmacy patients', 'aged polypharmacy patients in Spanish Community Pharmacies']","['comparison group (CG', 'medicine and educational interventions', 'community pharmacist', 'MRF', 'MRF service (advanced medication review-type 3 MR']","[""drug-related problems (DRPs) identified as potential causes of ineffective or unsafe medications and the pharmacists' interventions implemented during MRF provision"", 'risk of adverse effects', 'number of uncontrolled health problems']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0402003', 'cui_str': 'Community pharmacist'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",72.0,0.0878704,"The adjusted multi-level random effects models showed a significant reduction in the number of uncontrolled health problems over the periods in the IG (-0.72, 95% CI: -0.80, -0.65) and no change in the CG (-0.03, 95% CI: -0.10, 0.04).","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Varas-Doval', 'Affiliation': 'M.Pharm, BPharm, Pharmaceutical Services, Department of Innovation and Education, Spanish General Council of Official Pharmacists Associations. Madrid (Spain). raquelvaras@redfarma.org.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Gastelurrutia', 'Affiliation': 'PhD, MSc, BPharm. Pharmaceutical Research Group of the University of Granada, Faculty of Pharmacy, University of Granada. Granada (Spain). magastelu@farmanorte.org.'}, {'ForeName': 'Shalom I', 'Initials': 'SI', 'LastName': 'Benrimoj', 'Affiliation': 'PhD, BPharm (hons). Pharmaceutical Research Group of the University of Granada, Faculty of Pharmacy, University of Granada. Granada (Spain). shalom.benrimoj@gmail.com.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'García-Cárdenas', 'Affiliation': 'PhD, MPharm, BPharm. Senior Lecturer, Graduate School of Health, Discipline of Pharmacy University of Technology Sydney. Sydney, NSW (Australia). victoria.garciacardenas@uts.edu.au.'}, {'ForeName': 'Loreto', 'Initials': 'L', 'LastName': 'Sáez-Benito', 'Affiliation': 'PhD, MPharm. Teaching and Research Academic Staff, Faculty of Health Sciences, San Jorge University. Zaragoza (Spain). lsaezbenito@usj.es.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Martinez-Martínez', 'Affiliation': 'PhD, BPharm. Professor, Pharmaceutical Research Group of the University of Granada, Faculty of Pharmacy, University of Granada. Granada (Spain). femartin@ugr.es.'}]",Pharmacy practice,['10.18549/PharmPract.2020.4.2133']
2038,33150133,Comparative Effectiveness of Reperfusion Strategies in Patients with ST-Segment Elevation Myocardial Infarction: A Secondary Analysis of the Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Trial.,"Introduction
Substantial heterogeneity exists in reperfusion strategies for patients with ST-segment myocardial infarction (STEMI) in low- and middle-income countries (LMICs). We sought to compare outcomes associated with primary percutaneous coronary intervention (PPCI) and non-primary percutaneous coronary intervention (nPPCI) reperfusion strategies in patients with STEMI in Kerala, India.
Methods
We performed a retrospective analysis of patients with STEMI (n = 8665) from the Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) randomized trial receiving either PPCI (n = 6623) or nPPCI (n = 2042). nPPCI included all PCI strategies implemented when PPCI was not available including all post-fibrinolysis PCI strategies and PCI without fibrinolysis. Clinical outcomes among patients undergoing PPCI and nPPCI were compared after propensity-score matching. The main outcomes were the rates of in-hospital and 30-day major adverse cardiovascular events (MACE), defined as the composite of death, reinfarction, stroke, and major bleeding.
Results
In the propensity-score matched cohort (n = 1266 in each group), nPPCI had longer symptom onset to hospital arrival time (347.5 vs. 195.0 minutes, p < 0.001), door to balloon time (108 minutes vs. 75 minutes, p < 0.001), and were less likely to receive a coronary stent (89.4% vs. 95%, p < 0.001), including drug-eluting stents (89.5% vs. 94.4%, p < 0.001). There were no clinically meaningful differences in discharge medical therapy. However, patients treated with nPPCI were less commonly referred for cardiac rehabilitation (20.2% vs. 24.2%; p = 0.019). In-hospital (3.6% vs. 3.3%, p = 0.74%) and 30-day (4.4% vs. 4.6%, p = 0.77) MACE did not differ between nPPCI and PPCI matched groups.
Conclusion
In a large, contemporary population of STEMI patients from a LMIC, patients treated with a nPPCI reperfusion strategy had comparable short- and intermediate-term outcomes compared to PPCI despite differences in hospital presentation time and coronary stent use. These findings are reassuring but highlight the need for continued quality improvement in the delivery of STEMI care in resource-limited settings.",2020,"In-hospital (3.6% vs. 3.3%, p = 0.74%) and 30-day (4.4% vs. 4.6%, p = 0.77) MACE did not differ between nPPCI and PPCI matched groups.
","['patients with ST-segment myocardial infarction (STEMI) in low- and middle-income countries (LMICs', 'Patients with ST-Segment Elevation Myocardial Infarction', 'patients with STEMI in Kerala, India', 'patients with STEMI (n = 8665) from the Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) randomized trial receiving either PPCI (n = 6623) or nPPCI (n = 2042', 'patients undergoing PPCI and nPPCI']",['primary percutaneous coronary intervention (PPCI) and non-primary percutaneous coronary intervention (nPPCI) reperfusion strategies'],"['door to balloon time', 'Acute Coronary Syndrome Quality Improvement', 'cardiac rehabilitation', 'longer symptom onset to hospital arrival time', 'hospital presentation time and coronary stent use', 'discharge medical therapy', 'rates of in-hospital and 30-day major adverse cardiovascular events (MACE), defined as the composite of death, reinfarction, stroke, and major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0443018', 'cui_str': 'Kerala'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",8665.0,0.0963877,"In-hospital (3.6% vs. 3.3%, p = 0.74%) and 30-day (4.4% vs. 4.6%, p = 0.77) MACE did not differ between nPPCI and PPCI matched groups.
","[{'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Khraishah', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, US.'}, {'ForeName': 'Barrak', 'Initials': 'B', 'LastName': 'Alahmad', 'Affiliation': 'Environmental Health Department, Harvard T.H. Chan School of Public Health, Harvard University, Boston, MA, US.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Secemsky', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA, US.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Young', 'Affiliation': 'Cardiology Division, Dartmouth-Hitchcock Medical Center, Geisel School of Medicine, Dartmouth, Lebanon, NH, US.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'ElGuindy', 'Affiliation': 'Department of Cardiology, Aswan Heart Centre, EG.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Siedner', 'Affiliation': 'Division of Infectious Diseases and Medical Practice Evaluation Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, US.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Kassab', 'Affiliation': 'Cardiovascular Research Center, Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, US.'}, {'ForeName': 'Dhaval', 'Initials': 'D', 'LastName': 'Kholte', 'Affiliation': 'Cardiovascular Research Center, Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, US.'}, {'ForeName': 'Khuzeima', 'Initials': 'K', 'LastName': 'Khanbhai', 'Affiliation': 'Department of Adult Cardiology, Jakaya Kikwete Cardiac Institute, Dar es Salaam, TZ.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Janabi', 'Affiliation': 'Department of Adult Cardiology, Jakaya Kikwete Cardiac Institute, Dar es Salaam, TZ.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kennedy', 'Affiliation': ""Mid America Heart Institute, St Luke's Hospital, Kansas City, Missouri, US.""}, {'ForeName': 'Mazen S', 'Initials': 'MS', 'LastName': 'Albaghdadi', 'Affiliation': 'Cardiovascular Research Center, Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, US.'}]",Global heart,['10.5334/gh.868']
2039,33150170,"A Double-Blinded, Randomized, Vehicle-Controlled Study of the Efficacy of Moisturizer Containing Licochalcone A, Decanediol, L-Carnitine, and Salicylic Acid for Prevention of Acne Relapse in Asian Population.","Many topical agents are available for treating the acute phase of acne; however, few agents have been proven beneficial during the maintenance phase. Objective. To evaluate the efficacy and safety of moisturizer containing licochalcone A, 1,2-decanediol, L-carnitine, and salicylic acid during the maintenance phase of mild to moderate acne in Thai patients. Methods. One hundred and ten patients with mild to moderate acne vulgaris were initially treated with a fixed combination of adapalene 0.1%/benzoyl peroxide 2.5% gel once daily for 8 weeks. Fifty patients who achieved at least 50% reduction in lesion counts or at least a 2-grade improvement in the Investigator's Global Assessment (IGA) grade from baseline were enrolled in the maintenance phase, which was an investigator-masked, left-right comparison, randomized, controlled, intraindividual study. Moisturizers with and without the active study ingredients were applied twice a day to each side of the face, respectively, for 12 weeks. Assessments included acne lesion counts, acne severity by IGA scoring, skin bioengineering measurements, and skin tolerability as assessed by both patient and physician. Results. The treatment group had a significant reduction in the mean counts of noninflammatory, inflammatory, and total lesions compared to the vehicle group at week 12 and also between baseline and week 12. There was no significant difference in the mean scores for skin dryness, stinging/burning, or pruritus at any time point between groups. Conclusions. Moisturizer containing licochalcone A, 1,2-decanediol, L-carnitine, and salicylic acid reduced acne lesions and prevented the development of new lesions during the maintenance phase. This trial is registered with ClinicalTrials.gov registration no. NCT04002024.",2020,"There was no significant difference in the mean scores for skin dryness, stinging/burning, or pruritus at any time point between groups. ","['Asian Population', 'Fifty patients who achieved at least 50% reduction in', 'One hundred and ten patients with mild to moderate acne vulgaris', 'mild to moderate acne in Thai patients']","['Licochalcone A, Decanediol, L-Carnitine, and Salicylic Acid', 'adapalene 0.1%/benzoyl peroxide', 'Moisturizer Containing', 'Moisturizer containing licochalcone A, 1,2-decanediol, L-carnitine, and salicylic acid', 'moisturizer containing licochalcone A, 1,2-decanediol, L-carnitine, and salicylic acid']","['mean scores for skin dryness, stinging/burning, or pruritus', 'acne lesion counts, acne severity by IGA scoring, skin bioengineering measurements, and skin tolerability', 'mean counts of noninflammatory, inflammatory, and total lesions', 'lesion counts']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}]","[{'cui': 'C0125821', 'cui_str': 'licochalcone A'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0036079', 'cui_str': 'Salicylic Acid'}, {'cui': 'C0165631', 'cui_str': 'adapalene'}, {'cui': 'C0031180', 'cui_str': 'Peroxide'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4506622', 'cui_str': '1,2-decanediol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}, {'cui': 'C0677500', 'cui_str': 'Stinging'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0005539', 'cui_str': 'Engineering, Biomedical'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0442743', 'cui_str': 'Noninflammatory'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",110.0,0.12432,"There was no significant difference in the mean scores for skin dryness, stinging/burning, or pruritus at any time point between groups. ","[{'ForeName': 'Kanokvalai', 'Initials': 'K', 'LastName': 'Kulthanan', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Suphattra', 'Initials': 'S', 'LastName': 'Trakanwittayarak', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Papapit', 'Initials': 'P', 'LastName': 'Tuchinda', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Chularojanamontri', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pichaya', 'Initials': 'P', 'LastName': 'Limphoka', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Supenya', 'Initials': 'S', 'LastName': 'Varothai', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",BioMed research international,['10.1155/2020/2857812']
2040,33150192,Neuromuscular Training Improves Self-Reported Function and Single-Leg Landing Hip Biomechanics in Athletes After Anterior Cruciate Ligament Reconstruction.,"Background
Neuromuscular training (NMT) has been shown to attenuate high-risk biomechanics in uninjured athletes. At the time that athletes return to sport after anterior cruciate ligament (ACL) reconstruction (ACLR), they demonstrate hip biomechanical deficits associated with injury to the reconstructed knee versus the uninjured contralateral knee.
Purpose
The primary purpose of the study was to examine whether an NMT program can improve single-leg drop (SLD) landing hip biomechanics for athletes after ACLR. Secondarily, we compared the posttraining SLD hip biomechanics of athletes after ACLR with a control group of athletes who also completed the NMT program.
Study Design
Controlled laboratory study.
Methods
A total of 18 ACLR and 10 uninjured athletes were recruited and completed a 12-session NMT program. A knee-specific questionnaire and biomechanics of an SLD task was evaluated for each athlete before and after NMT. Paired t tests were used to compare pre- and posttraining International Knee Documentation Committee (IKDC) scores. Repeated-measures analysis of variance (ANOVA) was performed to assess the main effects and interactions of testing session × limb for the ACLR athletes. A 2-way ANOVA was conducted to quantify the interactions and main effects of group × limb.
Results
There was a significant increase ( P = .03) in IKDC scores from pre- to posttraining. For the ACLR athletes, there was a significant session × limb interaction for hip external rotation moment ( P = .02) and hip abduction angle ( P = .013). Despite increases in hip external rotation moment, no significant changes from pre- to posttraining were observed for the involved limbs. No significant changes were observed for hip abduction angle of the involved limbs between training sessions. Significant main effects of session ( P < .05) revealed that athletes landed with greater hip excursion, lower hip flexion moment, and lower ground-reaction force after training. The posttraining comparison between the ACLR and control groups found no significant group × limb interactions for any of the hip kinematic or kinetic variables. A significant main effect of group ( P < .05) revealed that the ACLR athletes landed with greater hip flexion angle and hip external rotation moment.
Conclusion
ACLR athletes demonstrated an improvement in SLD hip biomechanics and neuromuscular control after participating in an NMT program.
Clinical Relevance
This evidence indicates a potential role for NMT to improve hip biomechanics during an SLD task so as to reduce ACL injury risk.",2020,The posttraining comparison between the ACLR and control groups found no significant group × limb interactions for any of the hip kinematic or kinetic variables.,"['Athletes', 'After Anterior Cruciate Ligament Reconstruction', 'A total of 18 ACLR and 10 uninjured athletes were recruited and completed a 12-session NMT program', 'athletes after ACLR']","['\n\n\nNeuromuscular training (NMT', 'NMT', 'NMT program', 'anterior cruciate ligament (ACL) reconstruction (ACLR', 'Neuromuscular Training']","['hip flexion angle and hip external rotation moment', 'limb interactions', 'hip external rotation moment', 'IKDC scores', 'limb interaction for hip external rotation moment', 'hip abduction angle of the involved limbs', 'SLD hip biomechanics and neuromuscular control', 'hip abduction angle', 'pre- and posttraining International Knee Documentation Committee (IKDC) scores', 'hip excursion, lower hip flexion moment, and lower ground-reaction force']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",18.0,0.0190702,The posttraining comparison between the ACLR and control groups found no significant group × limb interactions for any of the hip kinematic or kinetic variables.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Nagelli', 'Affiliation': 'Rehabilitation Medicine Research Center, Musculoskeletal Gene Therapy Laboratory, and Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Di Stasi', 'Affiliation': 'Division of Physical Therapy, School of Health and Rehabilitation Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Tatarski', 'Affiliation': 'Sports Medicine Research Institute, The Ohio State Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Sports Medicine Research Institute, The Ohio State Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Wordeman', 'Affiliation': 'Sports Medicine Research Institute, The Ohio State Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Hoffman', 'Affiliation': 'Sports Medicine Research Institute, The Ohio State Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Hewett', 'Affiliation': 'Hewett Consulting, Minneapolis & Rochester, Minnesota, USA.'}]",Orthopaedic journal of sports medicine,['10.1177/2325967120959347']
2041,33151374,Acute rewarding and disinhibiting effects of alcohol as indicators of drinking habits.,"RATIONALE
Laboratory studies have reliably shown that heightened sensitivity to the rewarding effects of alcohol is associated with heavier drinking patterns. More recently, there has been research to suggest that heightened sensitivity to the disinhibiting effects of alcohol might also contribute to drinking habits. Most research on the acute effects of alcohol has focused on drinking magnitudes averaged across participants with little attention paid to how individual differences influence alcohol abuse potential. In large part, this is due to limited sample sizes in previous laboratory studies.
OBJECTIVES
This study overcomes previous limitations by testing the degree to which individual differences in acute sensitivity and tolerance to the rewarding and disinhibiting effects of alcohol relate to drinking behavior in a large sample size.
METHODS
Data from six laboratory studies were aggregated to comprise a sample of 181 adults. Participants' level of ""liking"" (the effects of alcohol) and disinhibition were assessed following 0.65 g/kg alcohol once during the ascending limb of the blood alcohol concentration (BAC) curve and again at the same BAC during the descending limb of the curve. The measures were also assessed following placebo.
RESULTS
Alcohol increased ratings of liking and behavioral disinhibition. Heavier drinking was associated with heightened sensitivity to liking on the ascending limb. Additionally, those who showed reduced acute tolerance to both disinhibition and liking were also heavier drinkers.
CONCLUSIONS
These data suggest that individual variability in liking the effects of alcohol and persistent disinhibition are key indicators of drinking habits.",2020,"RESULTS
Alcohol increased ratings of liking and behavioral disinhibition.",['Data from six laboratory studies were aggregated to comprise a sample of 181 adults'],[],"['ratings of liking and behavioral disinhibition', 'liking', 'blood alcohol concentration (BAC) curve', 'acute tolerance']","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0234410', 'cui_str': 'Disinhibition'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Concentration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",181.0,0.0201374,"RESULTS
Alcohol increased ratings of liking and behavioral disinhibition.","[{'ForeName': 'Holley C', 'Initials': 'HC', 'LastName': 'Allen', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY, 40506-0044, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Weafer', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY, 40506-0044, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Wesley', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY, 40506-0044, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Fillmore', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY, 40506-0044, USA. fillmore@uky.edu.'}]",Psychopharmacology,['10.1007/s00213-020-05667-w']
2042,33151422,Buffered 2% articaine versus non-buffered 4% articaine in maxillary infiltration: randomized clinical trial.,"OBJECTIVES
This randomized, triple-blind, crossover clinical trial aimed to evaluate the efficacy, onset, length of pulp and soft tissue anesthesia, and pain during injection of 2% buffered articaine and 4% non-buffered articaine solutions.
METHODS
Each volunteer received two maxillary supraperiosteal anesthesia infiltrations in canine area. The infiltrations were performed at two different sessions using a different local anesthetic solution for each session, and the anesthetic injection speed was always 1 mL/min. The assessment of the onset and length of pulpal and soft tissue anesthesia was performed with the pulp electrical test ""pulp tester"" and the esthesiometer kit, respectively. Volunteers marked pain during injection on a visual analog scale (VAS). The anesthetics solutions pH was evaluated through the pH meter equipment.
RESULTS
There was no difference between the two anesthetic solutions (onset of soft tissue anesthesia, p = 0.5386; length of soft tissue anesthesia, p = 0.718; onset of pulpal anesthesia, p = 0.747; length of pulpal anesthesia, p = 0.375), except for pain during the injection which was lower when buffered 2% articaine was used (p = 0.001) and the pH. The pH analysis revealed that the solutions differed from one another (p < 0.01).
CONCLUSION
The 2% buffered articaine solution provided the same anesthetic properties then 4% unbuffered articaine with a great reduction in pain during injection.
CLINICAL RELEVANCE
The possibility of use 2% buffered articaine solution instead of 4% articaine maintaining the same anesthetic properties with a great reduction in pain during injection and half of the anesthetic salt concentration.",2020,"There was no difference between the two anesthetic solutions (onset of soft tissue anesthesia, p = 0.5386; length of soft tissue anesthesia, p = 0.718; onset of pulpal anesthesia, p = 0.747; length of pulpal anesthesia, p = 0.375), except for pain during the injection which was lower when buffered 2% articaine was used (p = 0.001) and",[],"['articaine', 'articaine and 4% non-buffered articaine solutions', 'articaine solution', 'articaine versus non-buffered 4% articaine']","['visual analog scale (VAS', 'efficacy, onset, length of pulp and soft tissue anesthesia, and pain', 'pain']",[],"[{'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.140124,"There was no difference between the two anesthetic solutions (onset of soft tissue anesthesia, p = 0.5386; length of soft tissue anesthesia, p = 0.718; onset of pulpal anesthesia, p = 0.747; length of pulpal anesthesia, p = 0.375), except for pain during the injection which was lower when buffered 2% articaine was used (p = 0.001) and","[{'ForeName': 'Klinger Souza', 'Initials': 'KS', 'LastName': 'Amorim', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department, Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, Piracicaba, São Paulo, 13414-903, Brazil.'}, {'ForeName': 'Vanessa Tavares Silva', 'Initials': 'VTS', 'LastName': 'Fontes', 'Affiliation': 'Oral surgery and anesthesiology area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil. vanessa.tavares.se@gmail.com.'}, {'ForeName': 'Anne Caroline', 'Initials': 'AC', 'LastName': 'Gercina', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department, Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, Piracicaba, São Paulo, 13414-903, Brazil.'}, {'ForeName': 'Francisco Carlos', 'Initials': 'FC', 'LastName': 'Groppo', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department, Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, Piracicaba, São Paulo, 13414-903, Brazil.'}, {'ForeName': 'Liane Maciel Almeida', 'Initials': 'LMA', 'LastName': 'Souza', 'Affiliation': 'Oral surgery and anesthesiology area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil.'}]",Clinical oral investigations,['10.1007/s00784-020-03674-x']
2043,33151438,Acute and chronic effects of static stretching at 100% versus 120% intensity on flexibility.,"PURPOSE
The acute effects of static stretching have been frequently studied, but the chronic effects have not been studied concurrently. Thus, this study aimed to investigate both the acute and chronic effects of static stretching at different intensities on flexibility.
METHODS
Twenty-three healthy men were randomly assigned to perform 1 min of static stretching 3 days/week for 4 weeks at 100% intensity (n = 12) or 120% intensity (n = 11). The acute effects of stretching were assessed by measuring the range of motion (ROM), peak passive torque, and passive stiffness before and after every stretching session; the chronic effects of stretching were assessed by measuring these outcomes at baseline and after 2 and 4 weeks of stretching.
RESULTS
Compared with the 100% intensity group, the 120% intensity group had significantly greater acute increases in ROM after all 12 sessions, a significantly greater decrease in passive stiffness after 11 of 12 sessions, and a significantly greater increase in peak passive torque after six of 12 sessions. Regarding the chronic effects, ROM was significantly increased in both groups after 2 and 4 weeks of stretching. Peak passive torque significantly increased in the 100% intensity group after 2 and 4 weeks of stretching, and after 4 weeks in the 120% intensity group.
CONCLUSION
Stretching at 120% intensity resulted in significantly greater acute improvements in ROM, peak passive torque, and stiffness than stretching at 100% intensity. Four weeks of stretching increased ROM and peak passive torque but did not decrease passive stiffness, regardless of the stretching intensity.",2020,"Peak passive torque significantly increased in the 100% intensity group after 2 and 4 weeks of stretching, and after 4 weeks in the 120% intensity group.
",['Twenty-three healthy men'],['static stretching'],"['Peak passive torque', 'chronic effects, ROM', 'flexibility', 'acute improvements in ROM, peak passive torque, and stiffness', 'acute increases in ROM', 'range of motion (ROM), peak passive torque, and passive stiffness', 'peak passive torque', 'passive stiffness', 'ROM and peak passive torque']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",23.0,0.0270466,"Peak passive torque significantly increased in the 100% intensity group after 2 and 4 weeks of stretching, and after 4 weeks in the 120% intensity group.
","[{'ForeName': 'Taizan', 'Initials': 'T', 'LastName': 'Fukaya', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata, Niigata, 950-3198, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Matsuo', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Sciences, Nihon Fukushi University, 26-2 Higashihaemi-cho, Handa, Aichi, 475-0012, Japan. matsuo@n-fukushi.ac.jp.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Iwata', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Sciences, Nihon Fukushi University, 26-2 Higashihaemi-cho, Handa, Aichi, 475-0012, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Rehabilitation Medicine, Tokyo Bay Rehabilitation Hospital, 4-4-1 Yatsu, Narashino, Chiba, Japan.'}, {'ForeName': 'Wakako', 'Initials': 'W', 'LastName': 'Tsuchida', 'Affiliation': 'Department of Life Science and Biotechnology, Health Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), 2217-14 Hayashi-cho, Takamatsu, Kagawa, 761-0395, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Asai', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Sciences, Nihon Fukushi University, 26-2 Higashihaemi-cho, Handa, Aichi, 475-0012, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Department of Health and Sports Sciences, School of Health Sciences, Asahi University, 1851 Hozumi, Mizuho, Gifu, 501-0296, Japan.'}]",European journal of applied physiology,['10.1007/s00421-020-04539-7']
2044,33151474,The Effects of Suprasegmental Phonological Training on English Reading Comprehension: Evidence from Chinese EFL Learners.,"This study aims to investigate the effect of suprasegmental phonological training on connected-text reading comprehension of Chinese university students with different English reading proficiency levels. A sample of 160 freshmen was recruited and randomly divided into experimental and control groups, and the experimental group was given a 12-week training on stress, intonation and rhythm in English. Comparison and analysis of the subjects' reading comprehension performance, involving overall accuracy and speed as well as literal and inferential comprehension, reveal that: (1) suprasegmental phonological training exerts positive effects on the subjects' overall reading comprehension, especially on reading time and literal comprehension; (2) lower-proficiency readers improve more remarkably than higher-proficiency readers in terms of overall accuracy and literal comprehension, while the effect of the training on reading time is significant regardless of the subjects' reading proficiency. The results indicate that with explicit instruction and intensive exposure to suprasegmental knowledge, students' automaticity in lower level processing, such as parsing and understanding propositional messages, can be increased. From a perspective of interaction among different cognitive and psychological processes of reading comprehension, this study can shed light on developing students' reading comprehension in EFL contexts.",2020,"The results indicate that with explicit instruction and intensive exposure to suprasegmental knowledge, students' automaticity in lower level processing, such as parsing and understanding propositional messages, can be increased.","['Chinese university students with different English reading proficiency levels', 'A sample of 160 freshmen', ""students' reading comprehension in EFL contexts"", 'English Reading Comprehension: Evidence from Chinese EFL Learners']","['12-week training on stress, intonation and rhythm in English', 'Suprasegmental Phonological Training', 'suprasegmental phonological training']",[],"[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0449255', 'cui_str': 'Context'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0376245', 'cui_str': 'English language'}]",[],160.0,0.0165782,"The results indicate that with explicit instruction and intensive exposure to suprasegmental knowledge, students' automaticity in lower level processing, such as parsing and understanding propositional messages, can be increased.","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Cui', 'Affiliation': 'Department of Foreign Languages and Literatures, Tsinghua University, Beijing, China.'}, {'ForeName': 'Yuemin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Foreign Languages, University of Chinese Academy of Sciences, Yuquan Road 19#, Beijing, 100049, China. wym1898@126.com.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': 'Department of Foreign Languages and Literatures, Tsinghua University, Beijing, China.'}]",Journal of psycholinguistic research,['10.1007/s10936-020-09743-2']
2045,33151500,Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents with Autism Spectrum Disorder: Design of Two Phase III Studies (SIGN Trials).,"There are currently no approved pharmacological treatments to improve social reciprocity and limit repetitive and rigid behaviors in autism spectrum disorder (ASD). We describe the design of two Phase III studies evaluating the efficacy/safety of bumetanide oral liquid formulation in ASD. These are international, multicenter, randomized, double-blind, placebo-controlled studies in children and adolescents with ASD aged 7 to 17 years (n = 200; study 1), or younger children with ASD aged 2 to 6 years (n = 200; study 2). The primary endpoint of each is change in Childhood Autism Rating Scale 2 total raw score after 6 months. These studies could contribute to the first pharmacological treatment to improve social reciprocity and limit repetitive and rigid behaviors in children and adolescents with ASD.",2020,There are currently no approved pharmacological treatments to improve social reciprocity and limit repetitive and rigid behaviors in autism spectrum disorder (ASD).,"['Children and Adolescents with Autism', 'children and adolescents with ASD aged 7 to 17\xa0years (n\u2009=\u2009200; study 1), or younger children with ASD aged 2 to 6\xa0years (n\u2009=\u2009200; study 2', 'children and adolescents with ASD']","['Bumetanide Oral Liquid Formulation', 'bumetanide oral liquid formulation', 'placebo']","['Childhood Autism Rating Scale 2 total raw score', 'social reciprocity and limit repetitive and rigid behaviors']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0006376', 'cui_str': 'Bumetanide'}, {'cui': 'C1273619', 'cui_str': 'Oral Liquid Product'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0231517', 'cui_str': 'Rigid'}]",,0.141028,There are currently no approved pharmacological treatments to improve social reciprocity and limit repetitive and rigid behaviors in autism spectrum disorder (ASD).,"[{'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Crutel', 'Affiliation': 'Neuro Immuno-Inflammation Therapeutic Area, Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Lambert', 'Affiliation': 'Neuro Immuno-Inflammation Therapeutic Area, Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Penelaud', 'Affiliation': 'Neuro Immuno-Inflammation Therapeutic Area, Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Albarrán Severo', 'Affiliation': 'Neuro Immuno-Inflammation Therapeutic Area, Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Fuentes', 'Affiliation': 'Child & Adolescent Psychiatry Service, Policlínica Gipuzkoa & GAUTENA Autism Society, San Sebastián, Spain.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Rosier', 'Affiliation': 'Department of Neonatal Pediatrics, CHU de Rouen and CHU Le Rouvray, Sotteville les Rouen, France.'}, {'ForeName': 'Amaia', 'Initials': 'A', 'LastName': 'Hervás', 'Affiliation': 'Child and Adolescent Mental Health Service, Hospital Universitari Mútua de Terrassa, and Global Institute of Neurodevelopment Integrated Care (IGAIN), Barcelona, Spain.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Marret', 'Affiliation': 'Department of Neonatal Pediatrics, Intensive Care, and Neuropediatrics, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Guiomar', 'Initials': 'G', 'LastName': 'Oliveira', 'Affiliation': 'Neurodevelopmental and Autism Unit from Child Developmental Center and Centro de Investigação e Formação Clínica, Hospital Pediátrico, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Parellada', 'Affiliation': 'Servicio de Psiquiatría del Niño y del Adolescente Hospital General Universitario Gregorio Marañón, CIBERSAM, IiSGM, Ibiza 43, Madrid, Spain.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kyaga', 'Affiliation': 'Global Medical and Patient Affairs, Servier, 35 rue de Verdun, 92284, Suresnes cedex, Suresnes, France. simon.kyaga@servier.com.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Gouttefangeas', 'Affiliation': 'Neuro Immuno-Inflammation Therapeutic Area, Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Bertrand', 'Affiliation': 'Neuro Immuno-Inflammation Therapeutic Area, Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Ravel', 'Affiliation': 'Neurochlore, Marseille, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Falissard', 'Affiliation': 'University Paris-Sud, Univ. Paris-Descartes, AP-HP, INSERM U1178, Paris, France.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04709-8']
2046,33151597,"Effects of exenatide on microvascular reactivity in patients with type 2 diabetes and coronary artery disease, a randomized controlled study.","OBJECTIVE
We studied the effect of the glucagon-like peptide-1 receptor agonist (GLP-1RA) exenatide on skin microvascular function in patients with type 2 diabetes (T2DM) and coronary artery disease (CAD).
METHODS
Thirty-five patients with T2DM, CAD and glycated hemoglobin (HbA1C) 42-86 mmol/mol were randomised to treatment with exenatide or conventional non-GLP-1 based therapy for 12 weeks. Skin microvascular function was examined in the forearm by laser Doppler fluxmetry and iontophoretic application of acetyl choline and sodium nitroprusside, and by post occlusive reactive hyperaemia (PORH) at baseline and after 12 weeks. Blood samples for fasting plasma glucose, HbA1C and lipid profile were collected.
RESULTS
At 12 weeks, patients on exenatide showed reductions in HbA1C (from 63.5 ±13 to 60.7 ±14 mmol/mol, P=0.065), body weight (from 92.6 ±16 to 89 ±16 kg, P<0.001) and systolic blood pressure (from 141 ±13 to 134 ±16 mmHg, P<0.05) as compared to the conventionally treated group. There were no significant changes in skin microvascular function between or within the two groups at follow-up.
CONCLUSIONS
Three months daily treatment with the GLP-1RA exenatide in T2DM patients with CAD showed no significant effects on skin microvascular function or blood glucose control, while this study confirms a reduction in body weight and blood pressure by exenatide, as compared to conventional antidiabetic drug treatment.",2020,"Three months daily treatment with the GLP-1RA exenatide in T2DM patients with CAD showed no significant effects on skin microvascular function or blood glucose control, while this study confirms a reduction in body weight and blood pressure by exenatide, as compared to conventional antidiabetic drug treatment.","['Thirty-five patients with T2DM, CAD and glycated hemoglobin (HbA1C) 42-86 mmol/mol', 'patients with type 2 diabetes (T2DM) and coronary artery disease (CAD', 'patients with type 2 diabetes and coronary artery disease']","['exenatide', 'GLP-1RA exenatide', 'acetyl choline and sodium nitroprusside', 'exenatide or conventional non-GLP-1 based therapy', 'glucagon-like peptide-1 receptor agonist (GLP-1RA) exenatide']","['Skin microvascular function', 'HbA1C', 'microvascular reactivity', 'skin microvascular function', 'skin microvascular function or blood glucose control', 'body weight', 'Blood samples for fasting plasma glucose, HbA1C and lipid profile', 'systolic blood pressure', 'body weight and blood pressure']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0037533', 'cui_str': 'Sodium nitroprusside'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",35.0,0.0164723,"Three months daily treatment with the GLP-1RA exenatide in T2DM patients with CAD showed no significant effects on skin microvascular function or blood glucose control, while this study confirms a reduction in body weight and blood pressure by exenatide, as compared to conventional antidiabetic drug treatment.","[{'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Östlund Papadogeorgos', 'Affiliation': 'Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Cardiovascular Medicine, Stockholm, Sweden.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Kuhl', 'Affiliation': 'Karolinska Institutet, Department of Medicine, Solna, Stockholm, Sweden.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Shore', 'Affiliation': 'Diabetes and Vascular Medicine Research Centre, Institute of Biomedical and Clinical Science and University of Exeter College of Medicine and Health, Royal Devon and Exeter Hospital.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kahan', 'Affiliation': 'Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Cardiovascular Medicine, Stockholm, Sweden.'}, {'ForeName': 'Gun', 'Initials': 'G', 'LastName': 'Jörneskog', 'Affiliation': 'Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Medicine, Stockholm, Sweden.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Kalani', 'Affiliation': 'Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Cardiovascular Medicine, Stockholm, Sweden.'}]","Microcirculation (New York, N.Y. : 1994)",['10.1111/micc.12670']
2047,33151615,"A double-blind, placebo-controlled randomized trial of skin-lightening cream containing lycopene and wheat bran extract on melasma.","OBJECTIVE
Melasma is an acquired hyperpigmentation disorder, and reactive oxygen species play important role in regulating melanin synthesis. Lycopene is one of the most effective oxygen neutralizers among tomato-derived carotenoids. Also, hydroquinone is a compound that has been used for the treatment of hyperpigmentation by mechanism of tyrosinase inhibition and can be found in wheat.
METHODS
An appropriate cream formulation containing 0.05% tomato lycopene and 3.45% wheat bran extract was prepared, and physicochemical characterization was performed. The prepared formulations were applied twice a day for three months in combination with SPF = 30 sunscreen by 22 patients diagnosed with melasma. MASI score in two groups was evaluated at weeks 0, 3, 6, 9, and 12 and 1 month after the treatment.
RESULTS
The prepared formulation shows smooth and homogeneous appearance with suitable spreadability and viscosity. The MASI score of intervention group from the sixth week until the end of the treatment was significantly decreased compared to the onset of the treatment (P < .05), and the mean difference of the MASI score and the rate of skin discoloration in intervention group (0.53 ± 0.47 and 3.73 ± 1.90, respectively) were significantly higher than in placebo group (0.14 ± 0.20 and 0.91 ± 0.07, respectively; P < .05). Size of melasma during the study was decreased significantly from 6.59 ± 3.47 to 5.97 ± 3.83 (P < .05).
CONCLUSION
The data of mean difference of the MASI score indicated skin improvement in intervention group. Meanwhile, no recurrence was observed one month after the end of the treatment. These data suggest that the prepared formulation containing lycopene and wheat bran extract is safe and could be promising as an efficacious cosmetic treatment.",2020,"Size of melasma during the study was decreased significantly from 6.59 ± 3.47 to 5.97 ± 3.83 (P < .05).
","['22 patients diagnosed with melasma', 'melasma']","['hydroquinone', 'Lycopene', 'placebo', 'lycopene and wheat bran extract', 'skin-lightening cream containing lycopene and wheat bran extract', 'tomato lycopene and 3.45% wheat bran extract']","['Meanwhile, no recurrence', 'MASI score and the rate of skin discoloration', 'MASI score', 'Size of melasma']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]","[{'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C0065331', 'cui_str': 'lycopene'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3257534', 'cui_str': 'Wheat Bran extract'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1306868', 'cui_str': 'Lightening of fetus'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0242772', 'cui_str': 'Tomato'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0151907', 'cui_str': 'Discoloration of skin'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]",,0.0460447,"Size of melasma during the study was decreased significantly from 6.59 ± 3.47 to 5.97 ± 3.83 (P < .05).
","[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Bavarsad', 'Affiliation': 'Nanotechnology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mapar', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Safaezadeh', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Seyed Mahmoud', 'Initials': 'SM', 'LastName': 'Latifi', 'Affiliation': 'Diabetes Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13799']
2048,33147205,Percutaneous Reduction and Hollow Screw Fixation Versus Open Reduction and Internal Fixation for Treating Displaced Intra-Articular Calcaneal Fractures.,"BACKGROUND We investigated the outcomes of displaced intra-articular calcaneal fractures (DIACFs) treated by percutaneous reduction and hollow screw fixation (PRHCF) versus open reduction and internal fixation (ORIF). MATERIAL AND METHODS Seventy-one patients were randomly allocated to group A (by PRHCF) and group B (by ORIF). Operative time, visual analogue scale (VAS) score, time from injury to operation, postoperative hospital stay, preoperative and postoperative radiographic measurements, and complications were recorded. Functional outcomes were assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) scores. RESULTS Finally, 59 patients were followed up for at least 12 months (range, 12-24 months). Group A showed significantly more advantages than group B in term of operative time, intraoperative blood loss, time to operation, postoperative hospital stay, and postoperative pain relief during the first 3 days (P<0.001). However, more intraoperative fluoroscopy was required in group A than in group B (P<0.001). The calcaneal width, height, length, Böhler angle, and Gissane angle in each group were significantly improved postoperatively (all P<0.001), although not significantly different in the postoperative comparisons between both groups. The AOFAS scores were slightly superior in group A than in group B (88.3 vs. 86.4, P=0.08). The rate of incidence of postoperative complications was lower in group A than in group B (3.2% vs. 10.8%, respectively; OR, 0.28, 95% CI, 0.03 to 2.84), although there was no significant difference (P=0.337). CONCLUSIONS PRHCF showed comparable clinical and radiological outcomes as ORIF, demonstrating it is a safe and effective alternative in treating DIACFs.",2020,"Group A showed significantly more advantages than group B in term of operative time, intraoperative blood loss, time to operation, postoperative hospital stay, and postoperative pain relief during the first 3 days (P<0.001).",['Seventy-one patients'],"['displaced intra-articular calcaneal fractures (DIACFs) treated by percutaneous reduction and hollow screw fixation (PRHCF) versus open reduction and internal fixation (ORIF', 'PRHCF', 'Percutaneous Reduction and Hollow Screw Fixation', 'Internal Fixation']","['rate of incidence of postoperative complications', 'AOFAS scores', 'calcaneal width, height, length, Böhler angle, and Gissane angle', 'intraoperative fluoroscopy', 'Operative time, visual analogue scale (VAS) score, time from injury to operation, postoperative hospital stay, preoperative and postoperative radiographic measurements, and complications', 'operative time, intraoperative blood loss, time to operation, postoperative hospital stay, and postoperative pain relief', 'American Orthopaedic Foot and Ankle Society (AOFAS) scores']","[{'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332484', 'cui_str': 'Hollow shape'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]",71.0,0.0487851,"Group A showed significantly more advantages than group B in term of operative time, intraoperative blood loss, time to operation, postoperative hospital stay, and postoperative pain relief during the first 3 days (P<0.001).","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Lian', 'Affiliation': 'Department of Orthopedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': 'Department of Orthopedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Department of Orthopedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Zhenqin', 'Initials': 'Z', 'LastName': 'Jiao', 'Affiliation': 'Department of Orthopedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Lijie', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Orthopedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.926833']
2049,33147257,The avoidance of G-CSF and the addition of prophylactic corticosteroids after autologous stem cell transplantation for multiple myeloma patients appeal for the at-home setting to reduce readmission for neutropenic fever.,"BACKGROUND
Autologous stem cell transplantation (ASCT) remains the standard of care for young multiple myeloma (MM) patients; indeed, at-home ASCT has been positioned as an appropriate therapeutic strategy. However, despite the use of prophylactic antibiotics, neutropenic fever (NF) and hospital readmissions continue to pose as the most important limitations in the outpatient setting. It is possible that the febrile episodes may have a non-infectious etiology, and engraftment syndrome could play a more significant role. The aim of this study was to analyze the impact of both G-CSF withdrawal and the addition of primary prophylaxis with corticosteroids after ASCT.
METHODS
Between January 2002 and August 2018, 111 MM patients conditioned with melphalan were managed at-home beginning +1 day after ASCT. Three groups were established: Group A (n = 33) received standard G-CSF post-ASCT; group B (n = 32) avoided G-CSF post-ASCT; group C (n = 46) avoided G-CSF yet added corticosteroid prophylaxis post-ASCT.
RESULTS
The incidence of NF among the groups was reduced (64%, 44%, and 24%; P<0.001), with a non-significant decrease in hospital readmissions as well (12%, 6%, and 2%; P = 0.07). The most important variables identified for NF were: HCT-CI >2 (OR 6.1; P = 0.002) and G-CSF avoidance plus corticosteroids (OR 0.1; P<0.001); and for hospital readmission: age ≥60 years (OR 14.6; P = 0.04) and G-CSF avoidance plus corticosteroids (OR 0.07; P = 0.05).
CONCLUSIONS
G-CSF avoidance and corticosteroid prophylaxis post ASCT minimize the incidence of NF in MM patients undergoing at-home ASCT. This approach should be explored in a prospective randomized clinical trial.",2020,"The incidence of NF among the groups was reduced (64%, 44%, and 24%; P<0.001), with a non-significant decrease in hospital readmissions as well (12%, 6%, and 2%; P = 0.07).","['young multiple myeloma (MM) patients', 'MM patients undergoing at-home ASCT', 'Between January 2002 and August 2018, 111 MM patients conditioned with']","['prophylactic corticosteroids', 'Autologous stem cell transplantation (ASCT', 'standard G-CSF post-ASCT; group B (n = 32) avoided G-CSF post-ASCT; group C (n = 46) avoided G-CSF yet added corticosteroid prophylaxis post-ASCT', 'melphalan']","['hospital readmissions', 'incidence of NF']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}]",,0.0509138,"The incidence of NF among the groups was reduced (64%, 44%, and 24%; P<0.001), with a non-significant decrease in hospital readmissions as well (12%, 6%, and 2%; P = 0.07).","[{'ForeName': 'Luis-Gerardo', 'Initials': 'LG', 'LastName': 'Rodríguez-Lobato', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Martínez-Roca', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Castaño-Díez', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Palomino-Mosquera', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Gutiérrez-García', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Pedraza', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Suárez-Lledó', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Rovira', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Martínez', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fernández de Larrea', 'Affiliation': 'Department of Hematology, Amyloidosis and Multiple Myeloma Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'María-Teresa', 'Initials': 'MT', 'LastName': 'Cibeira', 'Affiliation': 'Department of Hematology, Amyloidosis and Multiple Myeloma Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rosiñol', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Lozano', 'Affiliation': 'Department of Hematology, Amyloidosis and Multiple Myeloma Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Marín', 'Affiliation': 'Department of Hemotherapy and Hemostasis, Apheresis and Cellular Therapy Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Cid', 'Affiliation': ""Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Lozano', 'Affiliation': ""Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Ana Belén', 'Initials': 'AB', 'LastName': 'Moreno-Castaño', 'Affiliation': 'Department of Hematopathology, Laboratory of Hemostasis and Eritropathology, Biomedical Diagnosis Center (CDB), Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Palomo', 'Affiliation': ""Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Díaz-Ricart', 'Affiliation': ""Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gallego', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Adelina', 'Initials': 'A', 'LastName': 'Hernando', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Segura', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Carreras', 'Affiliation': 'Barcelona Endothelium Team (BET), Josep Carreras Leukemia Research Institute, Barcelona, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Urbano-Ispizua', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Bladé', 'Affiliation': 'Department of Hematology, Amyloidosis and Multiple Myeloma Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Fernández-Avilés', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}]",PloS one,['10.1371/journal.pone.0241778']
2050,33147327,Effectiveness of doxycycline 100 mg twice daily for 7 days and azithromycin 1 g single dose for the treatment of rectal Chlamydia trachomatis infection among men who have sex with men.,"OBJECTIVES
To compare the effectiveness of doxycycline 100 mg twice daily for 7 days and azithromycin 1 g single dose for the treatment of rectal Chlamydia trachomatis infection among MSM in a real clinical setting.
METHODS
A prospective study was performed to compare the effectiveness of doxycycline and azithromycin for the treatment of rectal C. trachomatis among MSM in Tokyo, Japan. Subjects diagnosed with rectal C. trachomatis infection were treated and test-of-cure examination (TOC) was performed at least 3 weeks after the treatment. Treatment of rectal C. trachomatis infection was decided prospectively in a time-dependent manner; in the period between January 2017 and October 2018, azithromycin was administered to all subjects, whereas from October 2018 through March 2020, doxycycline was administered to all subjects. Effectiveness of these treatments was calculated by the number of rectal C. trachomatis-negative subjects at TOC divided by the number of subjects treated.
RESULTS
Two hundred and ninety-six MSM with rectal C. trachomatis infection were treated with azithromycin (80 patients) and doxycycline (216 patients) in a time-dependent manner. Of the 296 MSM, 274 (92.6%) were treated successfully [67 (83.7%, 95% CI = 79.6%-87.9%) in the azithromycin group versus 207 (95.8%, 95% CI = 94.5%-97.2%) in the doxycycline group, P < 0.001]. To evaluate factors associated with treatment failure, we performed logistic regression analysis. In univariate and multivariate analysis, only doxycycline treatment was inversely associated with treatment failure (OR = 0.29, 95% CI = 0.084-0.976, P = 0.046).
CONCLUSIONS
The treatment with doxycycline 100 mg twice daily for 7 days was superior to that with azithromycin 1 g single dose for rectal C. trachomatis among MSM in a real-world setting.",2020,"In univariate and multivariate analysis, only doxycycline treatment was inversely associated with treatment failure (OR = 0.29, 95% CI = 0.084-0.976, P = 0.046).
","['rectal C. trachomatis among MSM in Tokyo, Japan', 'Subjects diagnosed with rectal C. trachomatis infection', 'men who have sex with men', 'rectal Chlamydia trachomatis infection among MSM in a real clinical setting', 'Two hundred and ninety-six MSM with rectal C. trachomatis infection']","['azithromycin', 'doxycycline', 'doxycycline and azithromycin']","['treatment failure', 'rectal Chlamydia trachomatis infection']","[{'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0518948', 'cui_str': 'Chlamydia trachomatis infection'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C5191218', 'cui_str': '290'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0518948', 'cui_str': 'Chlamydia trachomatis infection'}]",296.0,0.0371955,"In univariate and multivariate analysis, only doxycycline treatment was inversely associated with treatment failure (OR = 0.29, 95% CI = 0.084-0.976, P = 0.046).
","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Mizushima', 'Affiliation': ''}, {'ForeName': 'Misao', 'Initials': 'M', 'LastName': 'Takano', 'Affiliation': 'AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Yanagawa', 'Affiliation': 'AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Aoki', 'Affiliation': 'AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Gatanaga', 'Affiliation': 'AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Kikuchi', 'Affiliation': 'AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Oka', 'Affiliation': 'AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa437']
2051,33147332,Anterior Approach vs Conventional Hepatectomy for Resection of Colorectal Liver Metastasis: A Randomized Clinical Trial.,"Importance
Tumor relapse after partial hepatectomy for colorectal liver metastasis (CRLM) remains an unsolved issue. Intraoperative manipulation of the liver during conventional hepatectomy might enhance hematogenous tumor cell spread. The anterior approach is an alternative approach that may reduce intraoperative tumor cell dissemination.
Objective
To determine the efficacy and safety of the anterior approach compared with conventional hepatectomy in patients undergoing resection for CRLM.
Design, Setting, and Participants
This randomized clinical study evaluated the efficacy and safety of the anterior approach compared with conventional hepatectomy in adult patients with CRLM who were scheduled for hepatectomy from February 1, 2003, to March 31, 2012, at a tertiary-care hospital. A total of 80 patients with CRLM were randomized to the anterior approach and conventional hepatectomy groups in a 1:1 ratio. Bone marrow and blood samples were analyzed for disseminated tumor cells and circulating tumor cells (CTC) using cytokeratin 20 reverse transcriptase-polymerase chain reaction analysis. Data were analyzed from April 1 to December 1, 2018, using intention to treat.
Interventions
Anterior approach vs conventional hepatectomy.
Main Outcomes and Measures
The primary end point was intraoperative CTC detection in central blood samples after liver resection. Secondary end points included postoperative morbidity, mortality, and long-term survival.
Results
Among the 80 patients included in the analysis (48 men [60%]; mean [SD] age, 61 [10] years), baseline characteristics, including preoperative CTC detection, were comparable between both groups. There was no statistically significant difference in intraoperative CTC detection between patients in the conventional hepatectomy (5 of 21 [24%]) and anterior approach (6 of 22 [27%]) groups (P = .54). Except for a longer operating time in the anterior approach group (mean [SD], 171 [53] vs 221 [53] minutes; P < .001), there were no significant differences in intraoperative and postoperative outcomes between both study groups. Although detection of CTC was associated with poor overall (median, 46 [95% CI, 40-52] vs 81 [95% CI, 54-107] months; P = .03) and disease-free (median, 40 [95% CI, 34-46] vs 60 [95% CI, 46-74] months; P = .04) survival, there was no significant difference in overall (median, 73 [95% CI, 42-104] vs 55 [95% CI, 35-75] months; P = .43) and disease-free (median, 48 [95% CI, 40-56] vs 40 [95% CI, 28-52] months; P = .88) survival between the conventional hepatectomy and anterior approach groups. Also, there was no significant difference in patterns of recurrence between both groups.
Conclusions and Relevance
This randomized clinical trial found that the anterior approach was not superior to conventional hepatectomy in reducing intraoperative tumor cell dissemination in patients undergoing resection of CRLM.
Trial Registration
isrctn.org Identifier: ISRCTN45066244.",2020,There was no statistically significant difference in intraoperative CTC detection between patients in the conventional hepatectomy (5 of 21 [24%]) and anterior approach (6 of 22 [27%]),"['patients undergoing resection for CRLM.\nDesign, Setting, and Participants', 'adult patients with CRLM who were scheduled for hepatectomy from February 1, 2003, to March 31, 2012, at a tertiary-care hospital', 'patients undergoing resection of CRLM', '80 patients with CRLM', 'Colorectal Liver Metastasis', '80 patients included in the analysis (48 men [60%]; mean [SD] age, 61 [10] years']","['Anterior Approach vs Conventional Hepatectomy', 'conventional hepatectomy', 'anterior approach', 'Interventions\n\n\nAnterior approach vs conventional hepatectomy', 'anterior approach and conventional hepatectomy']","['intraoperative and postoperative outcomes', 'intraoperative CTC detection in central blood samples', 'postoperative morbidity, mortality, and long-term survival', 'efficacy and safety', 'Bone marrow and blood samples', 'intraoperative CTC detection', 'patterns of recurrence', 'disease-free', 'longer operating time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",80.0,0.222177,There was no statistically significant difference in intraoperative CTC detection between patients in the conventional hepatectomy (5 of 21 [24%]) and anterior approach (6 of 22 [27%]),"[{'ForeName': 'Nuh N', 'Initials': 'NN', 'LastName': 'Rahbari', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Emrullah', 'Initials': 'E', 'LastName': 'Birgin', 'Affiliation': 'Department of Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Bork', 'Affiliation': 'Department of Gastrointestinal, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus at the Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Arianeb', 'Initials': 'A', 'LastName': 'Mehrabi', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Reißfelder', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Weitz', 'Affiliation': 'Department of Gastrointestinal, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus at the Technische Universität Dresden, Dresden, Germany.'}]",JAMA surgery,['10.1001/jamasurg.2020.5050']
2052,33147705,Impact of Long-Term Supplementation with Fish Oil in Individuals with Non-Alcoholic Fatty Liver Disease: A Double Blind Randomized Placebo Controlled Clinical Trial.,"Non-alcoholic fatty liver disease (NAFLD) is a chronic disease affecting up to 25% of the population worldwide. n-3 long-chain polyunsaturated fatty acids (n-3 PUFA) have been associated with improved clinical parameters of NAFLD. Our purpose was to conduct a pilot study to evaluate the effects of n-3 PUFA supplementation in a randomized, double-blind, placebo-controlled clinical study performed on NAFLD individuals diagnosed by ultrasound. Patients received n-3 PUFA ( n = 13) or placebo ( n = 11) supplementation for six months. Circulating miR-122 expression (determined by quantitative real time-polymerase chain reaction (qRT-PCR), liver fibrosis (FibroScan ® ), red blood cells (RBC) fatty acids (gas chromatography), and biochemical tests were performed at baseline and after intervention. After the intervention, in the n-3 PUFA group, docosahexaenoic acid (DHA) and omega index increased significantly in RBC ( p = 0.022 and p = 0.012, respectively), in addition to a significant reduction in alkaline phosphatase (ALP) ( p = 0.002) and liver fibrosis ( p = 0.039). However, there was no change in the expression of circulating miR-122 in both groups. Our results showed that omega-3 PUFA were incorporated in erythrocytes after six months of fish oil supplementary intake, and that n-3 PUFA were effective in reducing ALP and liver fibrosis without altering the expression of circulating miR-122 in individuals with NAFLD.",2020,"Circulating miR-122 expression (determined by quantitative real time-polymerase chain reaction (qRT-PCR), liver fibrosis (FibroScan ® ), red blood cells (RBC) fatty acids (gas chromatography), and biochemical tests were performed at baseline and after intervention.","['Alcoholic Fatty Liver Disease', 'Individuals with Non', 'NAFLD individuals diagnosed by ultrasound', 'individuals with NAFLD']","['Long-Term Supplementation with Fish Oil', 'omega-3 PUFA', 'n-3 PUFA supplementation', 'placebo', 'n-3 PUFA', 'n-3 long-chain polyunsaturated fatty acids (n-3 PUFA', 'Placebo']","['expression of circulating miR-122', 'ALP and liver fibrosis', 'quantitative real time-polymerase chain reaction (qRT-PCR), liver fibrosis (FibroScan ® ), red blood cells (RBC) fatty acids (gas chromatography), and biochemical tests', 'docosahexaenoic acid (DHA) and omega index', 'liver fibrosis', 'Circulating miR-122 expression', 'alkaline phosphatase (ALP']","[{'cui': 'C0015696', 'cui_str': 'Alcoholic fatty liver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0008555', 'cui_str': 'Gas chromatography measurement'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.450058,"Circulating miR-122 expression (determined by quantitative real time-polymerase chain reaction (qRT-PCR), liver fibrosis (FibroScan ® ), red blood cells (RBC) fatty acids (gas chromatography), and biochemical tests were performed at baseline and after intervention.","[{'ForeName': 'Kátia', 'Initials': 'K', 'LastName': 'Cansanção', 'Affiliation': 'Institute of Nutrition Josué de Castro of Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro 21.941-902, Brazil.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Citelli', 'Affiliation': 'Instituto de Nutrição, Universidade do Estado do Rio de Janeiro, Rio de Janeiro 20559-900, Brazil.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Carvalho Leite', 'Affiliation': 'Department of Internal Medicine, University Hospital Clementino Fraga Filho, School of Medicine of UFRJ, Rio de Janeiro 21.941-902, Brazil.'}, {'ForeName': 'María-Carmen', 'Initials': 'MC', 'LastName': 'López de Las Hazas', 'Affiliation': 'Laboratory of Epigenetics of Lipid Metabolism, Madrid Institute for Advanced Studies (IMDEA)-Food, CEI UAM+CSIC, 28049 Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Dávalos', 'Affiliation': 'Laboratory of Epigenetics of Lipid Metabolism, Madrid Institute for Advanced Studies (IMDEA)-Food, CEI UAM+CSIC, 28049 Madrid, Spain.'}, {'ForeName': 'Maria das Graças', 'Initials': 'MDG', 'LastName': 'Tavares do Carmo', 'Affiliation': 'Institute of Nutrition Josué de Castro of Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro 21.941-902, Brazil.'}, {'ForeName': 'Wilza Arantes Ferreira', 'Initials': 'WAF', 'LastName': 'Peres', 'Affiliation': 'Institute of Nutrition Josué de Castro of Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro 21.941-902, Brazil.'}]",Nutrients,['10.3390/nu12113372']
2053,33147721,A Randomised Controlled Trial to Evaluate the Administration of the Health Improvement Card as a Health Promotion Tool: A Physiotherapist-Led Community-Based Initiative.,"A randomised controlled trial was conducted to evaluate the administration of the Health Improvement Card (HIC) on lifestyle practices and biometric variables in community-dwelling Chinese participants. Adults living in Shanghai were randomly assigned to either the HIC-intervention or control group. Measurements/assessments were conducted at baseline and three-month follow-up. Supervised physiotherapy students administered the HIC and four standardised questionnaires related to health and wellbeing. Both groups received a health promotion education pamphlet. Based on participants' HIC biometric and lifestyle scores, students prescribed lifestyle, and exercise advice to the HIC-intervention group. 171 individuals (39 men, 132 women) (mean age 68.4 ± 9.7 y) participated. At follow-up, body mass index (BMI) and waist circumference decreased significantly in the HIC-intervention group. Furthermore, the number of participants in the HIC-intervention group categorised as low risk regarding their physical activity and dietary practices, increased by 32.2% and 20%, respectively. Changes in standardised questionnaire scores did not meet minimum clinically importance differences in either group. This is the first study to demonstrate that HIC-informed health promotion education can improve people's lifestyle practices, thereby, objective biometric variables. Evaluation of the effect of HIC-informed lifestyle education on some biometric parameters (blood pressure and BMI) may warrant a longer timeframe.",2020,"At follow-up, body mass index (BMI) and waist circumference decreased significantly in the HIC-intervention group.","['171 individuals (39 men, 132 women) (mean age 68.4 ± 9.7 y) participated', 'community-dwelling Chinese participants', 'Adults living in Shanghai']","['HIC-intervention or control group', 'Health Improvement Card (HIC', 'HIC-informed lifestyle education', 'health promotion education pamphlet']","['body mass index (BMI) and waist circumference', 'low risk regarding their physical activity and dietary practices', 'standardised questionnaire scores', 'biometric parameters (blood pressure and BMI']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C1272438', 'cui_str': 'Health promotion education'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",171.0,0.025954,"At follow-up, body mass index (BMI) and waist circumference decreased significantly in the HIC-intervention group.","[{'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Physical Therapy, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.'}, {'ForeName': 'Xubo', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Therapy, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.'}, {'ForeName': 'Raymond Cc', 'Initials': 'RC', 'LastName': 'Tsang', 'Affiliation': 'Department of Physiotherapy, MacLehose Rehabilitation Centre, Hong Kong, China.'}, {'ForeName': 'Ruisheng', 'Initials': 'R', 'LastName': 'Yun', 'Affiliation': 'Department of Physical Therapy, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Rehabilitation Medicine, Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai 200137, China.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Dean', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, BC V6T 1Z3, Canada.'}, {'ForeName': 'Alice Ym', 'Initials': 'AY', 'LastName': 'Jones', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane 4072, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17218065']
2054,33147751,The HYLAN M Study: Efficacy of 0.15% High Molecular Weight Hyaluronan Fluid in the Treatment of Severe Dry Eye Disease in a Multicenter Randomized Trial.,"The aim of the HYLAN M study was to investigate if symptoms and/or signs of patients suffering from severe dry eye disease (DED) can be improved by substituting individually optimized artificial tear therapy by high molecular weight hyaluronan (HMWHA) eye drops. In this international, multicenter study, patients with symptoms of at least ocular surface disease index (OSDI) 33 and corneal fluorescein staining (CFS) of at least Oxford grade 3 were included. A total of 84 per-protocol patients were randomized in two study arms. The control group continued to use their individual optimum artificial tears over the study period of eight weeks; in the verum group, the artificial tears were substituted by eye drops containing 0.15% HMWHA. At the week 8 visit, the average OSDI of the verum group had improved by 13.5 as compared to the control group ( p = 0.001). The best corrected visual acuity (BCVA) had improved by 0.04 logMAR ( p = 0.033). CFS, tear film break-up time (TBUT), Schirmer I, lid wiper epitheliopathy (LWE), mucocutaneous junction (Yamaguchi score), and tear osmolarity were not significantly different between the verum and control groups ( p > 0.050). We conclude that for most patients with severe DED, 0.15% HMWHA eye drops provide excellent improvement of symptoms without impairment of dry eye signs.",2020,The best corrected visual acuity (BCVA) had improved by 0.04 logMAR ( p = 0.033).,"['patients suffering from severe dry eye disease (DED', 'patients with symptoms of at least ocular surface disease index (OSDI) 33 and corneal fluorescein staining (CFS) of at least Oxford grade 3 were included', 'A total of 84 per-protocol patients']","['artificial tears were substituted by eye drops containing 0.15% HMWHA', '0.15% High Molecular Weight Hyaluronan Fluid']","['corrected visual acuity (BCVA', 'CFS, tear film break-up time (TBUT', 'Schirmer I, lid wiper epitheliopathy (LWE), mucocutaneous junction (Yamaguchi score), and tear osmolarity', 'average OSDI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]","[{'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}, {'cui': 'C0221941', 'cui_str': 'Mucocutaneous junction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0414436,The best corrected visual acuity (BCVA) had improved by 0.04 logMAR ( p = 0.033).,"[{'ForeName': 'Gysbert-Botho', 'Initials': 'GB', 'LastName': 'van Setten', 'Affiliation': 'Karolinska Institutet, Department of Clinical Neuroscience, St. Eriks Eye Hospital, 11282 Stockholm, Sweden.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Baudouin', 'Affiliation': 'Quinze-Vingts National Eye Hospital & Vision Institute, IHU Foresight, 75571 Paris, France.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Horwath-Winter', 'Affiliation': 'Department of Ophthalmology, Medical University Graz, 8036 Graz, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Böhringer', 'Affiliation': 'Eye Center, University Eye Hospital Freiburg and Medical Faculty, Albert Ludwigs University, 79106 Freiburg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Stachs', 'Affiliation': 'Department of Ophthalmology, University Medical Center Rostock, 18057 Rostock, Germany.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Toker', 'Affiliation': 'Department of Ophthalmology, Marmara University School of Medicine, 34899 Istanbul, Turkey.'}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Al-Zaaidi', 'Affiliation': 'Department of Ophthalmology, PSMMC Prince Sultan Military Medical City, MSD Medical Services Department, MODA Ministry of Defense and Aviation, Riyadh 12233, Saudi Arabia.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Benitez-Del-Castillo', 'Affiliation': 'Universidad Complutense de Madrid, Hospital Clinico San Carlos, Clinica Rementeria, 28040 Madrid, Spain.'}, {'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'Beck', 'Affiliation': 'Department of Ophthalmology, University Medical Center Rostock, 18057 Rostock, Germany.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Al-Sheikh', 'Affiliation': 'KKESH-King Khaled Eye Specialist Hospital, Riyadh 11462, Saudi Arabia.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Seitz', 'Affiliation': 'Department of Ophthalmology, Saarland University Medical Center, 66421 Homburg/Saar, Germany.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Barabino', 'Affiliation': 'Ocular Surface & Dry Eye Center, Ospedale L. Sacco, University of Milan, 20157 Milan, Italy.'}, {'ForeName': 'Herbert A', 'Initials': 'HA', 'LastName': 'Reitsamer', 'Affiliation': 'Department of Ophthalmology & Department of Experimental Ophthalmology and Glaucoma Research, University Clinic Salzburg, Paracelsus Medical University, 5020 Salzburg, Austria.'}, {'ForeName': 'Wolfgang G K', 'Initials': 'WGK', 'LastName': 'Müller-Lierheim', 'Affiliation': 'CORONIS GmbH, 81241 Munich, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9113536']
2055,33147764,The Predictive Role of Raw Bioelectrical Impedance Variables in Disordered Eating Attitudes in Female Ballet Dance Students.,"The present study used receiver operating characteristic (ROC) curve analysis to investigate the accuracy of body composition and raw bioelectrical impedance analysis (BIA) in correctly classifying disordered eating attitudes (DEA) in dance students. Participants were 81 female dancers assigned in two groups: beginner training (BT; age (mean ± SD) = 10.09 ± 1.2 years, n = 32) and advanced training (AT; age = 15.37 ± 2.1 years, n = 49). Fat mass (FM) was estimated by Slaughter's equation and skeletal muscle with Poortman's equation. Impedance (Z), resistance (R), reactance (Xc) and phase angle (PhA) were obtained through multifrequency BIA at a frequency of 50 kHz. Fat-free mass (FFM) was assessed using Sun's equation. For evaluation of DEA, the Eating Attitudes Test-26 (EAT-26) questionnaire was performed. We defined an EAT-26 score ≥ 20 as positive for DEA. Comparisons between groups were performed by a one-way ANOVA test or Kruskall-Wallis test. Spearman's rank correlation coefficients were performed to assess associations between variables. ROC curve analysis was utilized to test the accuracy of body composition and BIA variables in predicting DEA. In the BT group, Xc and PhA demonstrated high accuracy in predicting DEA with an area under the curve (AUC) of 0.976 (95% confidence interval (CI): 0.85-1.00) and 0.957 (95% CI: 0.82-0.99), respectively, (both p < 0.0001). FFM Sun had an AUC of 0.836 (95% CI: 0.66-0.94) ( p < 0.0001) in the BT group and FFM Slaughter was 0.797 (95% CI: 0.66-0.90) ( p < 0.001) in the AT group. Reactance and Phase angle were excellent and useful predictors of DEA in the BT group.",2020,FFM Sun had an AUC of 0.836 (95% CI: 0.66-0.94) ( p < 0.0001) in the BT group and,"['correctly classifying disordered eating attitudes (DEA) in dance students', 'Disordered Eating Attitudes in Female Ballet Dance Students', 'Participants were 81 female dancers assigned in two groups: beginner training (BT; age (mean ± SD) = 10.09 ± 1.2 years, n = 32) and advanced training (AT; age = 15.37 ± 2.1 years, n = 49']",['Raw Bioelectrical Impedance Variables'],"['Impedance (Z), resistance (R), reactance (Xc) and phase angle (PhA', 'FFM Slaughter', 'Fat mass (FM', 'Fat-free mass (FFM']","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0871967', 'cui_str': 'Ballet'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4068876', 'cui_str': '2.1'}]","[{'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]","[{'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0030779', 'cui_str': 'Pelger-Huët anomaly'}, {'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}]",,0.0804679,FFM Sun had an AUC of 0.836 (95% CI: 0.66-0.94) ( p < 0.0001) in the BT group and,"[{'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Alvero-Cruz', 'Affiliation': 'Department of Human Physiology, Histology, Pathological Anatomy and Physical Education and Sport, University of Málaga-Andalucía Technology Park, 29071 Málaga, Spain.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Parent Mathias', 'Affiliation': 'Department of Human Physiology, Histology, Pathological Anatomy and Physical Education and Sport, University of Málaga-Andalucía Technology Park, 29071 Málaga, Spain.'}, {'ForeName': 'Jerónimo C', 'Initials': 'JC', 'LastName': 'García Romero', 'Affiliation': 'Department of Human Physiology, Histology, Pathological Anatomy and Physical Education and Sport, University of Málaga-Andalucía Technology Park, 29071 Málaga, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Rosety', 'Affiliation': 'School of Medicine, University of Cádiz, 11003 Cádiz, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Rosety', 'Affiliation': 'School of Medicine, University of Cádiz, 11003 Cádiz, Spain.'}, {'ForeName': 'Antonio Jesus', 'Initials': 'AJ', 'LastName': 'Diaz', 'Affiliation': 'School of Nursing, University of Cádiz, 11003 Cádiz, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Ordoñez', 'Affiliation': 'School of Medicine, University of Cádiz, 11003 Cádiz, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rosety-Rodriguez', 'Affiliation': 'School of Medicine, University of Cádiz, 11003 Cádiz, Spain.'}]",Nutrients,['10.3390/nu12113374']
2056,33150554,How isolation of key information and allowing clarifying questions may improve information quality and diagnostic accuracy at case handover in paediatrics.,"Handover between colleagues is a complex task. The problem is that handovers are often inadequate because they are not structured according to theoretically grounded guidelines. Based on the cognitive load theory, we suggest that allowing a clarifying dialogue and thereby optimizing germane cognitive load enhances the information quality and diagnostic accuracy at handover, but may prolong handover duration. We also expect that mentioning key information first and thus decreasing intrinsic cognitive load improves information quality and diagnostic accuracy. We developed two representative paediatric cases for presentation in a factorial 2 × 2 design. Sixth-year medical students (N = 80) were randomly assigned to one of four groups that differed with regard to how the case histories were delivered to them (chronological order versus key information mentioned first) and direction of information exchange (unidirectional versus a clarifying dialogue). The receivers of the handover were asked to write a report of the cases and suggest the best diagnosis. Dependent variables were information quality of the written report (Information score), quality of the diagnosis (Diagnostic accuracy score) and the time it took to deliver the written handover case report (Handover report duration). Seen through the lens of cognitive load theory, allowing a clarifying dialogue at handover, and thus optimizing the germane cognitive load, significantly increased the Information score (p < 0.0005), Diagnostic accuracy score (< 0.05) and Handover report duration (p < 0.001).",2020,"Dependent variables were information quality of the written report (Information score), quality of the diagnosis (Diagnostic accuracy score) and the time it took to deliver the written handover case report (Handover report duration).",['Sixth-year medical students (N\u2009=\u200980'],['case histories were delivered to them (chronological order versus key information mentioned first) and direction of information exchange (unidirectional versus a clarifying dialogue'],"['information quality of the written report (Information score), quality of the diagnosis (Diagnostic accuracy score) and the time it took to deliver the written handover case report (Handover report duration', 'Diagnostic accuracy score', 'Information score']","[{'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0085970', 'cui_str': 'Case Histories'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007320', 'cui_str': 'Case Reports'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",80.0,0.0245219,"Dependent variables were information quality of the written report (Information score), quality of the diagnosis (Diagnostic accuracy score) and the time it took to deliver the written handover case report (Handover report duration).","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Balslev', 'Affiliation': 'Department of Paediatrics, Viborg Regional Hospital, Viborg, Denmark. thomas.balslev@midt.rm.dk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Muijtjens', 'Affiliation': 'Department of Educational Development and Research, Faculty of Health Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'de Grave', 'Affiliation': 'Department of Educational Development and Research, Faculty of Health Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Awneh', 'Affiliation': 'Department of Paediatrics, Viborg Regional Hospital, Viborg, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Merriënboer', 'Affiliation': 'Department of Educational Development and Research, Faculty of Health Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands.'}]",Advances in health sciences education : theory and practice,['10.1007/s10459-020-10001-2']
2057,33150572,Neuromuscular Electrical Stimulation and High-Protein Supplementation After Subarachnoid Hemorrhage: A Single-Center Phase 2 Randomized Clinical Trial.,"INTRODUCTION
Aneurysmal subarachnoid hemorrhage (SAH) survivors live with long-term residual physical and cognitive disability. We studied whether neuromuscular electrical stimulation (NMES) and high-protein supplementation (HPRO) in the first 2 weeks after SAH could preserve neuromotor and cognitive function as compared to standard of care (SOC) for nutrition and mobilization.
METHODS
SAH subjects with a Hunt Hess (HH) grade > 1,modified Fisher score > 1 and BMI < 40 kg/m 2 were randomly assigned to SOC or NMES + HPRO. NMES was delivered to bilateral quadricep muscles daily during two 30-min sessions along with HPRO (goal:1.8 g/kg/day) between post-bleed day (PBD) 0 and 14. Primary endpoint was atrophy in the quadricep muscle as measured by the percentage difference in the cross-sectional area from baseline to PBD14 on CT scan. All subjects underwent serial assessments of physical (short performance physical battery, SPPB) cognitive (Montreal Cognitive Assessment Scale, MoCA) and global functional recovery (modified Rankin Scale, mRS) at PBD 14, 42, and 90.
RESULTS
Twenty-five patients (SOC = 13, NMES + HPRO = 12) enrolled between December 2017 and January 2019 with no between-group differences in baseline characteristics (58 years old, 68% women, 50% HH > 3). Median duration of interventions was 12 days (range 9-14) with completion of 98% of NMES sessions and 83% of goal HPRO, and no reported serious adverse events. There was no difference in caloric intake between groups, but HPRO + NMES group received more protein (1.5 ± 0.5 g/kg/d v 0.9 ± 0.4 g/kg/d, P < 0.01). Muscle atrophy was less in NMES + HPRO than the SOC group (6.5 ± 4.1% vs 12.5 ± 6.4%, P 0.01). Higher atrophy was correlated with lower daily protein intake (ρ = - 0.45, P = 0.03) and lower nitrogen balance (ρ = 0.47, P = 0.02); and worse 3 month SPPB (ρ = - 0.31, P = 0.1) and mRS (ρ = 0.4, P = 0.04). NMES + HPRO patients had a better median [25%,75] SPPB (12[10, 12] v. 9 [4, 12], P = 0.01) and mRS (1[0,2] v.2[1, 3], P = 0.04) than SOC at PBD 90.
CONCLUSIONS
NMES + HPRO appears to be feasible and safe acutely after SAH and may reduce acute quadriceps muscle wasting with a lasting benefit on recovery after SAH.",2020,"Muscle atrophy was less in NMES + HPRO than the SOC group (6.5 ± 4.1% vs 12.5 ± 6.4%, P 0.01).","['Twenty-five patients (SOC\u2009=\u200913, NMES\u2009+\u2009HPRO\u2009=\u200912) enrolled between December 2017 and January 2019 with no between-group differences in baseline characteristics (58\xa0years old, 68% women, 50% HH\u2009>\u20093', 'SAH subjects with a Hunt Hess (HH) grade\u2009', 'After Subarachnoid Hemorrhage', '1,modified Fisher score\u2009>\u20091 and BMI\u2009<\u200940\xa0kg/m 2']","['NMES', 'Neuromuscular Electrical Stimulation and High-Protein Supplementation', 'neuromuscular electrical stimulation (NMES) and high-protein supplementation (HPRO']","['Higher atrophy', 'physical (short performance physical battery, SPPB) cognitive (Montreal Cognitive Assessment Scale, MoCA) and global functional recovery (modified Rankin Scale, mRS', 'Median duration of interventions', 'atrophy in the quadricep muscle', 'caloric intake', 'daily protein intake', 'Muscle atrophy', 'lower nitrogen balance', 'serious adverse events']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0429631', 'cui_str': 'Nitrogen balance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0776419,"Muscle atrophy was less in NMES + HPRO than the SOC group (6.5 ± 4.1% vs 12.5 ± 6.4%, P 0.01).","[{'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Badjatia', 'Affiliation': 'Program in Trauma, University of Maryland School of Medicine, 22 S. Greene Street G7K19, Baltimore, MD, 21201, USA. nbadjatia@som.umaryland.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sanchez', 'Affiliation': 'Departments of Neurology, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Judd', 'Affiliation': 'Department of Clinical Nutrition, University of Maryland Medical Center, Baltimore, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hausladen', 'Affiliation': 'Advanced Practice Provider Program, Neurocritical Care Unit, University of Maryland Medical Center, Baltimore, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hering', 'Affiliation': 'Advanced Practice Provider Program, Neurocritical Care Unit, University of Maryland Medical Center, Baltimore, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Motta', 'Affiliation': 'Program in Trauma, University of Maryland School of Medicine, 22 S. Greene Street G7K19, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Gunjan', 'Initials': 'G', 'LastName': 'Parikh', 'Affiliation': 'Program in Trauma, University of Maryland School of Medicine, 22 S. Greene Street G7K19, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Chang', 'Affiliation': 'Program in Trauma, University of Maryland School of Medicine, 22 S. Greene Street G7K19, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Morris', 'Affiliation': 'Program in Trauma, University of Maryland School of Medicine, 22 S. Greene Street G7K19, Baltimore, MD, 21201, USA.'}, {'ForeName': 'J Marc', 'Initials': 'JM', 'LastName': 'Simard', 'Affiliation': 'Department of Neurosurgery, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sorkin', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Wittenberg', 'Affiliation': 'Departments of Neurology, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Alice S', 'Initials': 'AS', 'LastName': 'Ryan', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, USA.'}]",Neurocritical care,['10.1007/s12028-020-01138-4']
2058,33150590,Airway immune mediator levels during asthma-like symptoms in young children and their possible role in response to azithromycin.,"BACKGROUND
Asthma-like symptoms in young children are orchestrated by the local airway immune response, but current knowledge largely relies on in vitro airway models. Azithromycin has been shown to reduce the duration of episodes with asthma-like symptoms but efficacy may depend on the individual child's immune response.
OBJECTIVES
To investigate in vivo upper airway immune mediator levels during episodes with asthma-like symptoms in young children and their ability to predict the clinical response to azithromycin treatment.
METHODS
535 children aged 0-3 years from the Copenhagen Prospective Studies of Asthma in Childhood-2010 mother-child cohort were examined for immune mediator levels in samples of nasal epithelial lining fluid during episodes with asthma-like symptoms as well as in the asymptomatic state. In a sub-study, children with recurrent asthma-like symptoms were randomized to either a 3-day course of oral azithromycin (10 mg/kg)(n=32) or placebo (n=38). In the current study, we compared the pre-treatment immune mediator levels with the clinical response to treatment with azithromycin in an exploratory posthoc analysis.
RESULTS
The immune mediator concentrations during vs outside episodes were significantly upregulated for IFN-ɣ (ratio 1.73), TNF-α (ratio 2.05), IL-1β (ratio 1.45), IL-10 (ratio 1.97), while CCL22 (ratio 0.65) was downregulated. Low levels of TNF-α and IL-10 and high levels of CCL22 predicted better treatment response to azithromycin (p-values < 0.05).
CONCLUSION
Upper airway immune mediator levels were altered during episodes of asthma-like symptoms, and levels of TNF-α, CCL22 and IL-10 may predict the response to azithromycin treatment.",2020,"Low levels of TNF-α and IL-10 and high levels of CCL22 predicted better treatment response to azithromycin (p-values < 0.05).
","['young children', 'episodes with asthma-like symptoms in young children', '535 children aged 0-3 years from the Copenhagen Prospective Studies of Asthma in Childhood-2010 mother-child cohort', 'children with recurrent asthma-like symptoms']","['Azithromycin', 'azithromycin', 'placebo', 'oral azithromycin']","['immune mediator concentrations', 'Low levels of TNF-α and IL-10 and high levels of CCL22', 'Upper airway immune mediator levels']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0674299', 'cui_str': 'CCL22 protein, human'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}]",535.0,0.0693218,"Low levels of TNF-α and IL-10 and high levels of CCL22 predicted better treatment response to azithromycin (p-values < 0.05).
","[{'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Carlsson', 'Affiliation': 'COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten A', 'Initials': 'MA', 'LastName': 'Rasmussen', 'Affiliation': 'COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Susanne B', 'Initials': 'SB', 'LastName': 'Pedersen', 'Affiliation': 'Department of Biotechnology and Biomedicine, Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'Ni', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Stokholm', 'Affiliation': 'COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bo L', 'Initials': 'BL', 'LastName': 'Chawes', 'Affiliation': 'COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Bønnelykke', 'Affiliation': 'COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Bisgaard', 'Affiliation': 'COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",Allergy,['10.1111/all.14651']
2059,31032636,"Intensive lipid lowering therapy reduces large, but not small, dense low-density lipoprotein particles measured by gel electrophoresis, in elderly patients with atrial fibrillation.",,2019,,['elderly patients with atrial fibrillation'],['Intensive lipid lowering therapy'],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}]",[],,0.0378032,,"[{'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Kjellmo', 'Affiliation': 'Division of Internal Medicine, Nordland Hospital, Bodø, Norway.'}, {'ForeName': 'Gheorghe', 'Initials': 'G', 'LastName': 'Pop', 'Affiliation': 'Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Knut T', 'Initials': 'KT', 'LastName': 'Lappegård', 'Affiliation': 'Division of Internal Medicine, Nordland Hospital, Bodø, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hovland', 'Affiliation': 'Division of Internal Medicine, Nordland Hospital, Bodø, Norway.'}]",European journal of preventive cardiology,['10.1177/2047487319845966']
2060,31473512,Maternal choline supplementation alters vitamin B-12 status in human and murine pregnancy.,"Despite participation in overlapping metabolic pathways, the relationship between choline and vitamin B-12 has not been well characterized especially during pregnancy. We sought to determine the effects of maternal choline supplementation on vitamin B-12 status biomarkers in human and mouse pregnancy, hypothesizing that increased choline intake would improve vitamin B-12 status. Associations between common genetic variants in choline-metabolizing genes and vitamin B-12 status biomarkers were also explored in humans. Healthy third-trimester pregnant women (n=26) consumed either 480 or 930 mg choline/day as part of a 12-week controlled feeding study. Wild-type NSA and Dlx3 heterozygous (Dlx3+/-) mice, which display placental insufficiency, consumed a 1×, 2× or 4× choline diet and were sacrificed at gestational days 15.5 and 18.5. Serum vitamin B-12, methylmalonic acid (MMA) and homocysteine were measured in all samples; holotranscobalamin (in humans) and hepatic vitamin B-12 (in mice) were also measured. The 2× choline supplementation for 12 weeks in pregnant women yielded higher serum concentrations of holotranscobalamin, the bioactive form of vitamin B-12 (~24%, P=.01). Women with genetic variants in choline dehydrogenase (CHDH) and betaine-homocysteine S-methyltransferase (BHMT) had higher serum MMA concentrations (~31%, P=.03) and lower serum holotranscobalamin concentrations (~34%, P=.03), respectively. The 4× choline dose decreased serum homocysteine concentrations in both NSA and Dlx3+/- mice (~36% and~43% respectively, P≤.015). In conclusion, differences in choline supply due to supplementation or genetic variation modulate vitamin B-12 status during pregnancy, supporting a functional relationship between these nutrients.",2019,"The 2× choline supplementation for 12 weeks in pregnant women yielded higher serum concentrations of holotranscobalamin, the bioactive form of vitamin B-12","['human and murine pregnancy', 'Healthy third-trimester pregnant women (n=26', 'Women with genetic variants in choline dehydrogenase (CHDH) and', 'human and mouse pregnancy']","['maternal choline supplementation', 'betaine-homocysteine S-methyltransferase (BHMT', 'consumed either 480 or 930 mg choline', 'Maternal choline supplementation', 'choline supplementation']","['Serum vitamin B-12, methylmalonic acid (MMA) and homocysteine', 'serum concentrations of holotranscobalamin, the bioactive form of vitamin B-12', 'serum MMA concentrations', 'serum homocysteine concentrations', 'vitamin B-12 status biomarkers', 'serum holotranscobalamin concentrations']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026809', 'cui_str': 'Mus'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0055570', 'cui_str': 'Choline dehydrogenase'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0556089', 'cui_str': 'Choline supplementation'}, {'cui': 'C0053518', 'cui_str': 'Betaine-homocysteine methyltransferase'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0008405', 'cui_str': 'Choline'}]","[{'cui': 'C0428581', 'cui_str': 'Serum vitamin A measurement'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0025787', 'cui_str': 'Methyl malonic acid'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0498303,"The 2× choline supplementation for 12 weeks in pregnant women yielded higher serum concentrations of holotranscobalamin, the bioactive form of vitamin B-12","[{'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'King', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY.'}, {'ForeName': 'Sze Ting Cecilia', 'Initials': 'STC', 'LastName': 'Kwan', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY.'}, {'ForeName': 'Sajin', 'Initials': 'S', 'LastName': 'Bae', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Klatt', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY.'}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Malysheva', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY.'}, {'ForeName': 'Xinyin', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY; Department of Health and Nutrition Sciences, Brooklyn College, Brooklyn, NY.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Roberson', 'Affiliation': 'Department of Biomedical Sciences, Cornell University, Ithaca, NY. Electronic address: msr14@cornell.edu.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Caudill', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY. Electronic address: mac379@cornell.edu.'}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2019.07.001']
2061,33151727,Does multidimensional forced-choice prevent faking? Comparing the susceptibility of the multidimensional forced-choice format and the rating scale format to faking.,"A common concern with self-reports of personality traits in selection contexts is faking. The multidimensional forced-choice (MFC) format has been proposed as an alternative to rating scales (RS) that could prevent faking. The goal of this study was to compare the susceptibility of the MFC format and the RS format to faking in a simulated high-stakes setting when using normative scoring for both formats. Participants were randomly assigned to 3 groups (total N = 1,867) and filled out the Big Five Triplets once under an honest instruction and once under a fake-good instruction. Latent mean differences between the honest and fake-good administrations indicated that the Big Five domains were faked in the expected direction. Faking effects for all traits were larger for RS compared with MFC. Faking effects were also larger for the MFC version with mixed triplets compared with the MFC version with triplets that were fully matched regarding their social desirability. The MFC format does not prevent faking completely, but it reduces faking substantially. Faking can be further reduced in the MFC format by matching the items presented in a block regarding their social desirability. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Faking effects were also larger for the MFC version with mixed triplets compared with the MFC version with triplets that were fully matched regarding their social desirability.,[],['filled out the Big Five Triplets once under an honest instruction and once under a fake-good instruction'],['Faking effects'],[],"[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0336043,Faking effects were also larger for the MFC version with mixed triplets compared with the MFC version with triplets that were fully matched regarding their social desirability.,"[{'ForeName': 'Eunike', 'Initials': 'E', 'LastName': 'Wetzel', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Frick', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'School of Psychology.'}]",Psychological assessment,['10.1037/pas0000971']
2062,33151749,"The Effect of Circuit Resistance Training on Plasma Levels of Amino acids, Alpha-hydroxybutyrate, Mannose, and Urinary Levels of Glycine Conjugated Adducts in Obese Adolescent Boys.","Few studies have examined the improving effects of exercise on the association between metabolites of impaired protein metabolism and insulin resistance in obese children. Therefore, this study aims to investigate the effect of circuit resistance training (CRT) on plasma levels of amino acids, alpha-hydroxybutyrate (α-HB), mannose, and urinary levels of glycine conjugated adducts in obese adolescent boys. Forty obese adolescent boys (BMI above the 95th percentile) with an age range of 14-17 were randomly divided into CRT group (n= 20) and control group (n= 20). The CRT program (3 times/week, 70-80% of 1 repetition maximum) was performed for 8 weeks. The results indicated that the body composition and plasma levels of glucose, insulin resistance, valine, mannose, lysine and the sum of branched-chain amino acids (BCAAs) were decreased due to CRT. The plasma levels of asparagine, glycine, serine, and urinary levels of glycine conjugated adduct also increased in the CRT group. Although α-HB level decreased during CRT, it had no significant difference from that of the control group. It can be concluded that the improvement in obesity complications including insulin resistance in obese adolescent boys after CRT may be due to decrease in plasma levels of mannose and BCAAs and increase urinary metabolites. Novelty Bullets: • CRT improves glucose metabolism and insulin resistance in obese adolescent boys. • CRT decreases plasma levels of mannose and BCAAs and normalizes other amino acids. • CRT increases urinary levels of glycine conjugated adducts.",2020,"The plasma levels of asparagine, glycine, serine, and urinary levels of glycine conjugated adduct also increased in the CRT group.","['obese adolescent boys', 'Forty obese adolescent boys (BMI above the 95th percentile) with an age range of 14-17', 'Obese Adolescent Boys', 'obese children']","['CRT', 'circuit resistance training (CRT', 'Circuit Resistance Training']","['body composition and plasma levels of glucose, insulin resistance, valine, mannose, lysine and the sum of branched-chain amino acids (BCAAs', 'glucose metabolism and insulin resistance', 'Plasma Levels of Amino acids, Alpha-hydroxybutyrate, Mannose, and Urinary Levels of Glycine Conjugated Adducts', 'α-HB level', 'plasma levels of asparagine, glycine, serine, and urinary levels of glycine conjugated adduct', 'plasma levels of mannose and BCAAs and increase urinary metabolites', 'plasma levels of amino acids, alpha-hydroxybutyrate (α-HB), mannose, and urinary levels of glycine conjugated adducts']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0024742', 'cui_str': 'Mannose'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C1291204', 'cui_str': '2-hydroxybutyrate'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0003995', 'cui_str': 'Asparagine'}, {'cui': 'C0036720', 'cui_str': 'Serine'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0299963,"The plasma levels of asparagine, glycine, serine, and urinary levels of glycine conjugated adduct also increased in the CRT group.","[{'ForeName': 'Seyed Ali', 'Initials': 'SA', 'LastName': 'Rasooli', 'Affiliation': 'University of Mazandaran, 48531, Babolsar, Iran (the Islamic Republic of); sa.rasouli@stu.umz.ac.ir.'}, {'ForeName': 'Rozita', 'Initials': 'R', 'LastName': 'Fathi', 'Affiliation': 'University of Mazandaran, 48531, babolsar, Babolsar, Iran (the Islamic Republic of), 4741613534; r.fathi@umz.ac.ir.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ahmadi-Kani Golzar', 'Affiliation': 'University of Mazandaran, 48531, Sabalan, Babolsar, Iran (the Islamic Republic of); f.kani@stu.umz.ac.ir.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Baghersalimi', 'Affiliation': 'University of Mazandaran, 48531, Babolsar, Iran (the Islamic Republic of); m.baghersalimi@stu.umz.ac.ir.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0171']
2063,33151775,Ascorbate attenuates cycling exercise-induced neuromuscular fatigue but fails to improve exertional dyspnea and exercise tolerance in COPD.,"We examined the effect of intravenous ascorbate administration (VitC) on exercise-induced redox balance, inflammation, exertional dyspnea, neuromuscular fatigue, and exercise tolerance in patients with chronic obstructive pulmonary disease (COPD). Eight COPD patients completed constant-load cycling (~80% of peak power output, 83±10W) to task-failure following intravenous VitC (2g) or saline (placebo, PL) infusion. All participants repeated the shorter of the two exercise trials (isotime), with the other infusate. Quadriceps fatigue was determined by pre- to post-exercise changes in quadriceps twitch-torque (∆Q tw , electrical femoral nerve stimulation). Corticospinal excitability before, during, and after exercise was assessed by changes in motor-evoked potentials triggered by transcranial magnetic stimulation. VitC increased superoxide dismutase (marker for endogenous antioxidant capacity) by 129% and mitigated C-reactive protein (marker for inflammation) in the plasma during exercise, but failed to alter the exercise-induced increase in lipid peroxidation (malondialdehyde) and free radicals (EPR-spectroscopy). While VitC did, indeed, decrease neuromuscular fatigue (∆Q tw PL: -29±5%, VitC: -23±6%, P<0.05), there was no impact on corticospinal excitability and time to task-failure (~8min, P=0.8). Interestingly, in terms of pulmonary limitations to exercise, VitC had no effect on perceived exertional dyspnea (~8.5/10) and its determinants, including S p O 2 (~92%) and respiratory muscle work (~650cmH 2 OŸsŸmin -1 ) (P>0.3). Thus, although VitC facilitated indicators for antioxidant capacity, diminished inflammatory markers, and improved neuromuscular fatigue resistance, it failed to improve exertional dyspnea and cycling exercise tolerance in patients with COPD. As dyspnea is recognized to limit exercise tolerance in COPD, the otherwise beneficial effects of VitC may have been impacted by this unaltered sensation.",2020,"VitC increased superoxide dismutase (marker for endogenous antioxidant capacity) by 129% and mitigated C-reactive protein (marker for inflammation) in the plasma during exercise, but failed to alter the exercise-induced increase in lipid peroxidation (malondialdehyde) and free radicals (EPR-spectroscopy).","['Eight COPD patients completed', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD']","['intravenous VitC (2g) or saline (placebo, PL) infusion', 'intravenous ascorbate administration (VitC']","['superoxide dismutase', 'exertional dyspnea and exercise tolerance', 'lipid peroxidation (malondialdehyde) and free radicals (EPR-spectroscopy', 'exertional dyspnea and cycling exercise tolerance', 'Quadriceps fatigue', 'exertional dyspnea', 'neuromuscular fatigue ', 'quadriceps twitch-torque (∆Q tw , electrical femoral nerve stimulation', 'neuromuscular fatigue resistance', 'corticospinal excitability and time to task-failure', 'constant-load cycling', 'exercise-induced redox balance, inflammation, exertional dyspnea, neuromuscular fatigue, and exercise tolerance', 'Corticospinal excitability']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0201898', 'cui_str': 'Ascorbic acid measurement'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0231807', 'cui_str': 'Dyspnea on exertion'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0016693', 'cui_str': 'Free radical'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0015808', 'cui_str': 'Structure of femoral nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",8.0,0.0886949,"VitC increased superoxide dismutase (marker for endogenous antioxidant capacity) by 129% and mitigated C-reactive protein (marker for inflammation) in the plasma during exercise, but failed to alter the exercise-induced increase in lipid peroxidation (malondialdehyde) and free radicals (EPR-spectroscopy).","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Hureau', 'Affiliation': 'Department of Medicine, University of Strasbourg, France.'}, {'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Weavil', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, University of Utah, United States.'}, {'ForeName': 'Simranjit K', 'Initials': 'SK', 'LastName': 'Sidhu', 'Affiliation': 'School of Medicine, University of Adelaide, Australia.'}, {'ForeName': 'Taylor S', 'Initials': 'TS', 'LastName': 'Thurston', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, United States.'}, {'ForeName': 'Van R', 'Initials': 'VR', 'LastName': 'Reese', 'Affiliation': 'Department of Internal Medicine, University of Utah, United States.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Internal Medicine, University of Utah, United States.'}, {'ForeName': 'Ashley D', 'Initials': 'AD', 'LastName': 'Nelson', 'Affiliation': 'Pulmonary and Critical Care, University of Utah, United States.'}, {'ForeName': 'Nathaniel M', 'Initials': 'NM', 'LastName': 'Birgenheier', 'Affiliation': 'Department of Anesthesiology, University of Utah, United States.'}, {'ForeName': 'Russell S', 'Initials': 'RS', 'LastName': 'Richardson', 'Affiliation': 'Department of Internal Medicine, University of Utah, United States.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Amann', 'Affiliation': 'Department of Internal Medicine, University of Utah, United States.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00611.2020']
2064,33151778,Muscle pain from an intramuscular injection of hypertonic saline increases variability in knee extensor torque reproduction.,"PURPOSE
The intensity of exercise-induced pain (EIP) reflects the metabolic environment in the exercising muscle, so during endurance exercise this may inform the intelligent regulation of work rate. Conversely, the acute debilitating effects of EIP on motor unit recruitment could impair the estimation of force produced by the muscle and impair judgement of current exercise intensity. This study investigated whether muscle pain that feels like EIP, administered via intramuscular injection of hypertonic saline, interferes with the ability to accurately reproduce torque in a muscle group relevant to locomotive exercise.
METHODS
On separate days, fourteen participants completed an isometric torque reproduction task of the knee extensors. Participants were required to produce torque at 15 and 20% maximal voluntary torque (MVIT), without visual feedback before (Baseline), during (Pain/No Pain), and after (Recovery) an injection of 0.9% isotonic saline (Control) or 5.8% hypertonic saline (Experimental) into the vastus lateralis of the right leg.
RESULTS
An elevated reported intensity of pain, and a significantly increased variance in mean contraction torque at both 15% (P=0.049) and 20% (P=0.002) MVIT was observed in the Experimental compared to the Control condition. Both 15 and 20% target torques were performed at a similar pain intensity in the Experimental condition (15% MVIT, 4.2 ± 1.9; 20% MVIT, 4.5 ± 2.2; P>0.05).
CONCLUSION
These findings demonstrate that the increased muscle pain from the injection of hypertonic saline impeded accurate reproduction of knee extensor torque. These findings have implications for the detrimental impact of EIP on exercise regulation and endurance performance.",2020,"An elevated reported intensity of pain, and a significantly increased variance in mean contraction torque at both 15% (P=0.049) and 20% (P=0.002)",[],"['isotonic saline (Control) or 5.8% hypertonic saline (Experimental) into the vastus lateralis of the right leg', 'exercise-induced pain (EIP', 'hypertonic saline', 'isometric torque reproduction task of the knee extensors']","['accurate reproduction of knee extensor torque', 'intensity of pain', 'MVIT', 'muscle pain', 'pain intensity', 'maximal voluntary torque (MVIT), without visual feedback before (Baseline), during (Pain/No Pain', 'knee extensor torque reproduction', 'mean contraction torque']",[],"[{'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0230415', 'cui_str': 'Structure of right lower limb'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]",,0.063708,"An elevated reported intensity of pain, and a significantly increased variance in mean contraction torque at both 15% (P=0.049) and 20% (P=0.002)","[{'ForeName': 'Samuel Andrew', 'Initials': 'SA', 'LastName': 'Smith', 'Affiliation': 'School of Sport and Exercise Sciences, University of Kent, United Kingdom.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Micklewright', 'Affiliation': 'School of Sport, Rehabilitation and Exercise Sciences, University of Kent, United Kingdom.'}, {'ForeName': 'Samantha Lee', 'Initials': 'SL', 'LastName': 'Winter', 'Affiliation': 'School of Sport and Exercise Sciences, University of Kent, United Kingdom.'}, {'ForeName': 'Alexis R', 'Initials': 'AR', 'LastName': 'Mauger', 'Affiliation': 'School of Sport and Exercise Sciences, University of Kent, United Kingdom.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00139.2020']
2065,33151802,Do knee injection portals affect clinical results of bone marrow aspirate concentrate injection in the treatment of osteoarthritis? A prospective randomized controlled study.,"Aim: To explore the effect that the location of needle placement has on efficacy and tolerability of bone marrow aspirate concentrate injections during treatment of knee osteoarthritis. Methods: Bone marrow aspirate concentrate injections were administered to 111 patients via superolateral, anteromedial or anterolateral portals. Pain was assessed by visual analog scale before and 3, 7, 14 and 21 days after intervention. Knee function was assessed by Western Ontario and McMaster Universities Osteoarthritis Index, Knee Injury and Osteoarthritis Outcome Score and International Knee Documentation Committee scores before and 1, 3, 6, 9 and 12 months after intervention. Results: Significant differences in Western Ontario and McMaster Universities Osteoarthritis Index, Knee Injury and Osteoarthritis Outcome Score and International Knee Documentation Committee scores were observed 12 months post intervention compared with baseline (p < 0.001 for all comparisons). No significant differences in outcome or pain scores were observed among groups. Conclusion: All portals demonstrated similar clinical benefits up to 12 months after intervention. Trial registration number: ClinicalTrials.gov (NCT03825133).",2020,No significant differences in outcome or pain scores were observed among groups. ,"['111 patients via superolateral, anteromedial or anterolateral portals']","['Bone marrow aspirate concentrate injections', 'needle placement', 'bone marrow aspirate concentrate injections']","['visual analog scale', 'scores', 'outcome or pain scores', 'Western Ontario and McMaster Universities Osteoarthritis Index, Knee Injury and Osteoarthritis Outcome Score and International Knee Documentation Committee scores', 'Knee function', 'Pain', 'efficacy and tolerability', 'Western Ontario and McMaster Universities Osteoarthritis Index, Knee Injury and Osteoarthritis Outcome Score and International Knee Documentation Committee']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0205054', 'cui_str': 'Portal'}]","[{'cui': 'C0857285', 'cui_str': 'Bone marrow aspirate'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",111.0,0.17973,No significant differences in outcome or pain scores were observed among groups. ,"[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Dulic', 'Affiliation': 'University of Novi Sad, Medical Faculty, Clinical Center of Vojvodina, Department for Orthopedic Surgery & Traumatology, Hajduk Veljkova 1-9, Novi Sad, Serbia.'}, {'ForeName': 'Ivica', 'Initials': 'I', 'LastName': 'Lalic', 'Affiliation': 'University of Novi Sad, Medical Faculty, Clinical Center of Vojvodina, Department for Orthopedic Surgery & Traumatology, Hajduk Veljkova 1-9, Novi Sad, Serbia.'}, {'ForeName': 'Vaso', 'Initials': 'V', 'LastName': 'Kecojevic', 'Affiliation': 'University of Novi Sad, Medical Faculty, Clinical Center of Vojvodina, Department for Orthopedic Surgery & Traumatology, Hajduk Veljkova 1-9, Novi Sad, Serbia.'}, {'ForeName': 'Gordan', 'Initials': 'G', 'LastName': 'Gavrilovic', 'Affiliation': 'Atlas Hospital,\xa0Osmana Djikica 5, Belgrade, Serbia.'}, {'ForeName': 'Dzihan', 'Initials': 'D', 'LastName': 'Abazovic', 'Affiliation': 'Renova Hospital,\xa0Osmana Djikica 5, Belgrade, Serbia.'}, {'ForeName': 'Mladen', 'Initials': 'M', 'LastName': 'Miskulin', 'Affiliation': 'Specijalna bolnica za Neurokirurgiju i ortopediju Aksis, Zagreb, Petrovaradinska\xa01, 10000 ZAGREB, Croatia.'}, {'ForeName': 'Dusan', 'Initials': 'D', 'LastName': 'Maric', 'Affiliation': 'MD Orto Hospital, Futoski put 115, Novi Sad, Serbia.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Bumbasirevic', 'Affiliation': 'University of Belgrade, Medical Faculty, Clinical Center of Serbia, Clinic for Orthopedic Surgery & Traumatology, Dr. Subotica 20, Belgrade, Serbia.'}]",Regenerative medicine,['10.2217/rme-2020-0020']
2066,33151971,"Maternal dysglycaemia, changes in the infant's epigenome modified with a diet and physical activity intervention in pregnancy: Secondary analysis of a randomised control trial.","BACKGROUND
Higher maternal plasma glucose (PG) concentrations, even below gestational diabetes mellitus (GDM) thresholds, are associated with adverse offspring outcomes, with DNA methylation proposed as a mediating mechanism. Here, we examined the relationships between maternal dysglycaemia at 24 to 28 weeks' gestation and DNA methylation in neonates and whether a dietary and physical activity intervention in pregnant women with obesity modified the methylation signatures associated with maternal dysglycaemia.
METHODS AND FINDINGS
We investigated 557 women, recruited between 2009 and 2014 from the UK Pregnancies Better Eating and Activity Trial (UPBEAT), a randomised controlled trial (RCT), of a lifestyle intervention (low glycaemic index (GI) diet plus physical activity) in pregnant women with obesity (294 contol, 263 intervention). Between 27 and 28 weeks of pregnancy, participants had an oral glucose (75 g) tolerance test (OGTT), and GDM diagnosis was based on diagnostic criteria recommended by the International Association of Diabetes and Pregnancy Study Groups (IADPSG), with 159 women having a diagnosis of GDM. Cord blood DNA samples from the infants were interrogated for genome-wide DNA methylation levels using the Infinium Human MethylationEPIC BeadChip array. Robust regression was carried out, adjusting for maternal age, smoking, parity, ethnicity, neonate sex, and predicted cell-type composition. Maternal GDM, fasting glucose, 1-h, and 2-h glucose concentrations following an OGTT were associated with 242, 1, 592, and 17 differentially methylated cytosine-phosphate-guanine (dmCpG) sites (false discovery rate (FDR) ≤ 0.05), respectively, in the infant's cord blood DNA. The most significantly GDM-associated CpG was cg03566881 located within the leucine-rich repeat-containing G-protein coupled receptor 6 (LGR6) (FDR = 0.0002). Moreover, we show that the GDM and 1-h glucose-associated methylation signatures in the cord blood of the infant appeared to be attenuated by the dietary and physical activity intervention during pregnancy; in the intervention arm, there were no GDM and two 1-h glucose-associated dmCpGs, whereas in the standard care arm, there were 41 GDM and 160 1-h glucose-associated dmCpGs. A total of 87% of the GDM and 77% of the 1-h glucose-associated dmCpGs had smaller effect sizes in the intervention compared to the standard care arm; the adjusted r2 for the association of LGR6 cg03566881 with GDM was 0.317 (95% confidence interval (CI) 0.012, 0.022) in the standard care and 0.240 (95% CI 0.001, 0.015) in the intervention arm. Limitations included measurement of DNA methylation in cord blood, where the functional significance of such changes are unclear, and because of the strong collinearity between treatment modality and severity of hyperglycaemia, we cannot exclude that treatment-related differences are potential confounders.
CONCLUSIONS
Maternal dysglycaemia was associated with significant changes in the epigenome of the infants. Moreover, we found that the epigenetic impact of a dysglycaemic prenatal maternal environment appeared to be modified by a lifestyle intervention in pregnancy. Further research will be needed to investigate possible medical implications of the findings.
TRIAL REGISTRATION
ISRCTN89971375.",2020,Cord blood DNA samples from the infants were interrogated for genome-wide DNA methylation levels using the Infinium Human MethylationEPIC BeadChip array.,"['Between 27 and 28 weeks of pregnancy, participants had an oral glucose (75 g) tolerance test (OGTT), and GDM diagnosis was based on diagnostic criteria recommended by the International Association of Diabetes and Pregnancy Study Groups (IADPSG), with 159 women having a diagnosis of GDM', 'pregnant women with obesity modified the methylation signatures associated with maternal dysglycaemia', '557 women, recruited between 2009 and 2014 from the UK Pregnancies Better Eating and Activity Trial (UPBEAT', 'pregnant women with obesity (294 contol, 263 intervention']","['diet and physical activity intervention', 'dietary and physical activity intervention', 'lifestyle intervention (low glycaemic index (GI) diet plus physical activity']","['maternal plasma glucose (PG) concentrations', 'Maternal GDM, fasting glucose, 1-h, and 2-h glucose concentrations']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}]",557.0,0.0673385,Cord blood DNA samples from the infants were interrogated for genome-wide DNA methylation levels using the Infinium Human MethylationEPIC BeadChip array.,"[{'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Antoun', 'Affiliation': 'Biological Sciences, Institute of Developmental Sciences, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Negusse T', 'Initials': 'NT', 'LastName': 'Kitaba', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Titcombe', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Kathryn V', 'Initials': 'KV', 'LastName': 'Dalrymple', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Emma S', 'Initials': 'ES', 'LastName': 'Garratt', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Sheila J', 'Initials': 'SJ', 'LastName': 'Barton', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Murray', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Joanna D', 'Initials': 'JD', 'LastName': 'Holbrook', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kobor', 'Affiliation': 'BC Childrens Hospital Research Institute, Centre for Molecular Medicine and Therapeutics, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'David Ts', 'Initials': 'DT', 'LastName': 'Lin', 'Affiliation': 'BC Childrens Hospital Research Institute, Centre for Molecular Medicine and Therapeutics, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'MacIsaac', 'Affiliation': 'BC Childrens Hospital Research Institute, Centre for Molecular Medicine and Therapeutics, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Graham C', 'Initials': 'GC', 'LastName': 'Burdge', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'White', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Poston', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Lillycrop', 'Affiliation': 'Biological Sciences, Institute of Developmental Sciences, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003229']
2067,33151986,A model mimicking catabolic inflammatory disease; a controlled randomized study in humans.,"OBJECTIVE
Inflammatory disease is catabolic and associated with insulin resistance, increased energy expenditure, lipolysis and muscle protein loss. The main contributors to these metabolic adaptations are inflammation, malnutrition and immobilisation. Controlled experimental models incorporating these central elements of hospitalisation are lacking. The aim of this study was to validate such a human experimental model.
METHODS
In a randomized crossover design, six healthy young men underwent; (i) overnight fast (CTR), or (ii) exposure to systemic lipopolysaccharide (1 ng/kg) combined with 36-hour fast and bed rest (CAT). The difference in insulin sensitivity between CAT and CTR was the main outcome, determined by a hyperinsulinemic euglycemic glucose clamp. Palmitate, glucose, urea, phenylalanine and tyrosine tracers were infused to estimate metabolic shifts during interventions. Indirect calorimetry was used to estimate energy expenditure and substrate oxidation.
RESULTS
Insulin sensitivity was 41% lower in CAT than in CTR (M-value, mg/kg/min): 4.3 ± 0.2 vs 7.3 ± 1.3, p<0.05. The median (min max) palmitate flux (μmol/min) was higher during CAT than in CTR (257.0 (161.7 365.4) vs 131.6 (92.3 189.4), p = 0.004), and protein kinetics did not differ between interventions. C-reactive peptide (mg/L) was elevated in CAT compared with CTR (30.57 ± 4.08 vs 1.03 ± 0.19, p<0.001). Energy expenditure increased by 6% during CAT compared with CTR (1869 ± 94 vs 1756 ± 58, p = 0.04), CAT having higher lipid oxidation rates (p = 0.01) and lower glucose oxidation rates (p = 0.03). Lipopolysaccharide caused varying abdominal discomfort 2 hours post-injection, which had disappeared the following day.
CONCLUSION
We found that combined systemic inflammation, fasting and bed rest induced marked insulin resistance and increased energy expenditure and lipolysis, rendering this controlled experimental model suitable for anti-catabolic intervention studies, mimicking clinical conditions.",2020,"RESULTS
Insulin sensitivity was 41% lower in CAT than in CTR (M-value, mg/kg/min): 4.3 ± 0.2 vs 7.3 ± 1.3, p<0.05.","['six healthy young men underwent', 'humans']","['Lipopolysaccharide', 'i) overnight fast (CTR), or (ii) exposure to systemic lipopolysaccharide (1 ng/kg) combined with 36-hour fast and bed rest (CAT']","['protein kinetics', 'insulin sensitivity', 'lipid oxidation rates', 'Insulin sensitivity', 'Energy expenditure', 'median (min max) palmitate flux', 'glucose oxidation rates', 'hyperinsulinemic euglycemic glucose clamp', 'Palmitate, glucose, urea, phenylalanine and tyrosine tracers']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1638318', 'cui_str': 'ng/kg'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015159', 'cui_str': 'Euglycemic Clamping'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}]",6.0,0.109541,"RESULTS
Insulin sensitivity was 41% lower in CAT than in CTR (M-value, mg/kg/min): 4.3 ± 0.2 vs 7.3 ± 1.3, p<0.05.","[{'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Mose', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Rittig', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ulla Ramer', 'Initials': 'UR', 'LastName': 'Mikkelsen', 'Affiliation': 'Nutrition & Health, R&D, Arla Foods Ingredients Group P/S, Viby, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'STENO Diabetes Center, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mads Bisgaard', 'Initials': 'MB', 'LastName': 'Bengtsen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Brit', 'Initials': 'B', 'LastName': 'Christensen', 'Affiliation': 'Arla Foods amba, Aarhus, Denmark.'}, {'ForeName': 'Jens Otto Lunde', 'Initials': 'JOL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}]",PloS one,['10.1371/journal.pone.0241274']
2068,33151988,Efficacy and safety of short-term therapy with indigo naturalis for ulcerative colitis: An investigator-initiated multicenter double-blind clinical trial.,"INTRODUCTION
Indigo naturalis (IN) is a blue pigment extracted from Assam indigo and other plants and has been confirmed to be highly effective for ulcerative colitis (UC) treatment in several clinical studies.
OBJECTIVE
We conducted a multicenter double-blind study to confirm the efficacy and safety of short-term IN administration.
METHODS
A multicenter, randomized controlled trial was conducted between December 2015 and October 2018 in our facilities. Forty-six patients with mild to moderate active UC (Lichtiger index: 5-10) were randomly assigned to the IN group or the placebo group and received 5 capsules (500 mg) twice a day for 2 weeks. We investigated the efficacy according to blood tests and the Lichtiger index before and after administration, and we also examined adverse events.
RESULTS
The analysis included 42 patients (20 males, 22 females) with an average age of 45 years. Nineteen patients were assigned to the placebo group, and 23 were assigned to the IN group. After treatment administration, in the placebo group, no change in the Lichtiger index was observed (7.47 to 6.95, p = 0.359), and hemoglobin was significantly reduced (12.7 to 12.4, p = 0.031), while in the IN group, the Lichtiger index (9.04 to 4.48, p = 0.001) and albumin (4.0 to 4.12, p = 0.022) improved significantly. Mild headaches were observed in 5 patients and 1 patient in the IN and placebo groups, respectively.
CONCLUSIONS
Short-term administration of IN is highly effective without serious adverse events such as pulmonary hypertension or intussusception and may prevent the occurrence of serious adverse events.",2020,"CONCLUSIONS
Short-term administration of IN is highly effective without serious adverse events such as pulmonary hypertension or intussusception and may prevent the occurrence of serious adverse events.","['ulcerative colitis', 'Forty-six patients with mild to moderate active UC', 'Nineteen patients', 'December 2015 and October 2018 in our facilities', '42 patients (20 males, 22 females) with an average age of 45 years']","['placebo', 'short-term therapy with indigo naturalis']","['efficacy and safety', 'Lichtiger index', 'Efficacy and safety', 'hemoglobin', 'Mild headaches']","[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021218', 'cui_str': 'Indigo'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",46.0,0.22389,"CONCLUSIONS
Short-term administration of IN is highly effective without serious adverse events such as pulmonary hypertension or intussusception and may prevent the occurrence of serious adverse events.","[{'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Uchiyama', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University Kashiwa Hospital, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Takami', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University Kashiwa Hospital, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Umeki', 'Affiliation': 'Department of Gastroenterology, Chiba-Nishi General Hospital, Matsudo, Chiba, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Mochizuki', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Tokatsu Tsujinaka Hospital, Abiko, Chiba, Japan.'}, {'ForeName': 'Nobushige', 'Initials': 'N', 'LastName': 'Kakinoki', 'Affiliation': 'Department of Gastroenterology, Hitachi General Hospital, Hitachi, Ibaraki, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Iwamoto', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Tokyo Medical University Ibaraki Medical Center, Inashiki-gun, Ibaraki, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Hoshino', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Yatsu Hoken Hospital, Narashino, Chiba, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Omori', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Chiba, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Fujimori', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Chiba, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Yanaka', 'Affiliation': 'Department of Gastroenterology, Hitachi Medical Education and Research Center, University of Tsukuba Hospital, Hitachi, Ibaraki, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Mizokami', 'Affiliation': 'Department of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Ohkusa', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University Kashiwa Hospital, Kashiwa, Chiba, Japan.'}]",PloS one,['10.1371/journal.pone.0241337']
2069,31921133,Activatory Receptor NKp30 Predicts NK Cell Activation During Controlled Human Malaria Infection.,"Natural killer (NK) cells are known to be activated during malaria infection, exhibiting both cytokine production and cytotoxic functions. However, NK cells are heterogeneous in their expression of surface activatory and inhibitory receptors which may influence their response to malaria parasites. Here, we studied the surface marker profile and activation dynamics of NK cells during a Controlled Human Malaria Infection in 12 healthy volunteers. Although there was significant inter-patient variability in timing and magnitude of NK cell activation, we found a consistent and strong increase in expression of the activatory receptor NKp30. Moreover, high baseline NKp30 expression was associated with NK cell activation at lower parasite densities. Our data suggest that NKp30 expression may influence the NK cell response to P. falciparum , explaining inter-patient heterogeneity and suggesting a functional role for this receptor in malaria.",2019,"Moreover, high baseline NKp30 expression was associated with NK cell activation at lower parasite densities.",['12 healthy volunteers'],[],['expression of the activatory receptor NKp30'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]",12.0,0.0225399,"Moreover, high baseline NKp30 expression was associated with NK cell activation at lower parasite densities.","[{'ForeName': 'Jona', 'Initials': 'J', 'LastName': 'Walk', 'Affiliation': 'Department of Medical Microbiology and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Sauerwein', 'Affiliation': 'Department of Medical Microbiology and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, Netherlands.'}]",Frontiers in immunology,['10.3389/fimmu.2019.02864']
2070,32527251,Requirements for (web-based) physical activity interventions targeting adults above the age of 65 years - qualitative results regarding acceptance and needs of participants and non-participants.,"BACKGROUND
It remains unclear how physical activity (PA) interventions need to be designed to reach older adults and to be widely accepted in this target group. The aim of this study was to assess the acceptance of a web-based PA program, including individual intervention components as well as relevant contextual factors, and to specify requirements for future interventions.
METHODS
Two hundred sixty-six participants of a PA intervention completed a questionnaire covering individual program components (content, structure, and context). Further, 25 episodic guided interviews focusing on reasons for (non-) participation were conducted with 8 participants and 17 non-participants. Following qualitative content analysis, different requirements were identified and organized based on the social-ecological model, resulting in a profile of requirements.
RESULTS
Based on the participants' and non-participants' statements, six different levels of requirements affecting acceptance of and successful participation in a web-based PA intervention were identified. The individual fit was influenced by an interaction of different factors at the intrapersonal, sociocultural, content, spatial, digital and organizational levels. Several age- and gender-specific requirements were noted in the interviewed older adults. Men and women, as well as younger (< 70 years) and older (≥70 years) adults differed in terms of perceived enjoyment and benefits of socializing while exercising together, the time expenditure perceived to be acceptable, previous digital skills, as well as in perceptions that ambience and accessibility of exercise facilities in the neighborhood were important.
CONCLUSIONS
To motivate older adults to engage in PA and address different needs in terms of life circumstances and quality of life as well as differences in technical affinity, different requirement profiles should be included in the process of intervention development and implementation. Participatory development loops and modular offer formats are recommended for this.",2020,"The individual fit was influenced by an interaction of different factors at the intrapersonal, sociocultural, content, spatial, digital and organizational levels.","['targeting adults above the age of 65\u2009years - qualitative results regarding acceptance and needs of participants and non-participants', '25 episodic guided interviews focusing on reasons for (non-) participation were conducted with 8 participants and 17 non-participants', 'Men and women, as well as younger (<\u200970\u2009years) and older (≥70\u2009years) adults', 'Two hundred sixty-six participants of a PA intervention completed a questionnaire covering individual program components (content, structure, and context']",['physical activity interventions'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0449255', 'cui_str': 'Context'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],266.0,0.0254995,"The individual fit was influenced by an interaction of different factors at the intrapersonal, sociocultural, content, spatial, digital and organizational levels.","[{'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Wichmann', 'Affiliation': 'Institute for Public Health und Nursing Sciences - IPP, University of Bremen, Bremen, Germany. wichmann@leibniz-bips.de.'}, {'ForeName': 'Claudia R', 'Initials': 'CR', 'LastName': 'Pischke', 'Affiliation': 'Institute of Medical Sociology, Centre for Health and Society, Medical Faculty, Heinrich-Heine-University Duesseldorf, Duesseldorf, Germany.'}, {'ForeName': 'Dorothee', 'Initials': 'D', 'LastName': 'Jürgens', 'Affiliation': 'Department Prevention and Evaluation, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Darmann-Finck', 'Affiliation': 'Institute for Public Health und Nursing Sciences - IPP, University of Bremen, Bremen, Germany.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Koppelin', 'Affiliation': 'Jade University of Applied Sciences Wilhelmshaven/Oldenburg/Elsfleth, Section Technology and Health for Humans, Oldenburg, Germany.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Lippke', 'Affiliation': 'Department of Psychology & Methods, Jacobs University Bremen, Bremen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Pauls', 'Affiliation': 'Jade University of Applied Sciences Wilhelmshaven/Oldenburg/Elsfleth, Section Technology and Health for Humans, Oldenburg, Germany.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Peters', 'Affiliation': 'Department Prevention and Evaluation, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Voelcker-Rehage', 'Affiliation': 'Institute of Human Movement Science and Health, Faculty of Behavioural and Social Sciences, Chemnitz University of Technology, Chemnitz, Germany.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Muellmann', 'Affiliation': 'Department Prevention and Evaluation, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.'}]",BMC public health,['10.1186/s12889-020-08927-8']
2071,33147073,Wearable Respiratory Monitoring and Feedback for Chronic Pain in Adult Survivors of Childhood Cancer: A Feasibility Randomized Controlled Trial From the Childhood Cancer Survivor Study.,"PURPOSE
Approximately 40% of childhood cancer survivors experience chronic pain, with many also reporting pain-related disability. Given associations established in the general population among respiration, anxiety, and pain, continuous tracking and feedback of respiration may help survivors manage pain.
METHODS
A feasibility, nonblinded, randomized controlled trial (RCT) comparing wearable respiratory monitoring with a control group examined feasibility, acceptability, and preliminary efficacy among survivors of childhood cancer with chronic pain who were ≥ 18 years of age, able to speak and read English, lived in the United States, and had access to a smartphone and the Internet. The primary outcomes were pain interference, pain severity, anxiety, negative affect, and perceived stress. The intervention group (n = 32) received a wearable respiratory monitor, used the device, and completed an in-application breathing exercise daily for 30 days. The control group (n = 33) received psychoeducation after completion of the study.
RESULTS
Almost all participants in the intervention group (n = 31 of 32) and control group (n = 32 of 33) completed the study. Of those who completed the intervention, 90.3% wore the device for ≥ 50% of the trial. Posttreatment improvement for negative affect (Cohen d = 0.59; 95% CI, 0.09 to 1.10) was significantly greater in the intervention group compared with the control group. A follow-up study (n = 24) examined acceptability and feasibility of a second-generation device among those who completed the RCT. Most survivors (81.0%) wore the device daily during the trial and 85.7% reported satisfaction with the device and the application.
CONCLUSION
The results of this pilot study support the acceptability and feasibility of wearable respiratory monitoring among survivors of childhood cancer. Larger randomized trials are needed to assess efficacy and maintenance of this intervention for chronic pain.",2020,"Posttreatment improvement for negative affect (Cohen d = 0.59; 95% CI, 0.09 to 1.10) was significantly greater in the intervention group compared with the control group.","['survivors of childhood cancer', 'survivors of childhood cancer with chronic pain who were ≥ 18 years of age, able to speak and read English, lived in the United States, and had access to a smartphone and the Internet', 'childhood cancer survivors experience chronic pain, with many also reporting pain-related disability', 'Adult Survivors of Childhood Cancer']","['Wearable Respiratory Monitoring and Feedback', 'wearable respiratory monitor, used the device, and completed an in-application breathing exercise daily for 30 days']","['pain interference, pain severity, anxiety, negative affect, and perceived stress']","[{'cui': 'C4505050', 'cui_str': 'Survivors of Childhood Cancer'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0564215', 'cui_str': 'Able to speak'}, {'cui': 'C1277154', 'cui_str': 'Reads English'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0199438', 'cui_str': 'Monitoring of respiration'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1321577', 'cui_str': 'Respiratory monitor'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.138938,"Posttreatment improvement for negative affect (Cohen d = 0.59; 95% CI, 0.09 to 1.10) was significantly greater in the intervention group compared with the control group.","[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Alberts', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Leisenring', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Flynn', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Whitton', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Gibson', 'Affiliation': 'National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Jibb', 'Affiliation': 'The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ford', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Neema', 'Initials': 'N', 'LastName': 'Moraveji', 'Affiliation': 'Spire Health, San Francisco, CA.'}, {'ForeName': 'Blake F', 'Initials': 'BF', 'LastName': 'Dear', 'Affiliation': 'Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Krull', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Leslie L', 'Initials': 'LL', 'LastName': 'Robison', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Stinson', 'Affiliation': 'The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Armstrong', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}]",JCO clinical cancer informatics,['10.1200/CCI.20.00070']
2072,33147353,Combined short- and long-axis method for internal jugular vein catheterization in premature newborns: A randomized controlled trial.,"BACKGROUND
Rapid central venous catheterization is critical for the rescue and perioperative management of premature infants requiring surgery. Ultrasound-guided dynamic needle tip positioning (DNTP) has been widely used as a very effective technique, especially in paediatric vascular puncture and catheterization. However, for low-weight premature newborns, central vein catheterization still poses greater difficulties for paediatricians and paediatric anaesthesiologists. This prospective randomized control study aimed to evaluate the efficacy of combined short- and long-axis (CSLA) internal jugular vein catheterization for premature newborns in comparison with the DNTP technique.
METHODS
A total of 90 premature newborns (gestational age <37 weeks and <28 d after birth) who were scheduled for surgery were included in this study. All enrolled premature newborns were randomly divided into two groups (n=45): the CSLA group and the DNTP group. We compared the first-puncture success rate, total success rate, procedure time, number of needle passes, occurrence of complications and other outcome measures between the two groups.
RESULTS
The two groups (n=45 per group) were similar in sex, gestational age, weight, mean arterial blood pressure, and vein-related measurements of the internal jugular vein. Total success was achieved in 43 (95.6%) and 36 (80.0%) patients in the CSLA and DNTP groups, respectively. Compared with the DNTP group, the CSLA group showed a significantly higher first-attempt success rate (71.1% vs. 46.7%, χ 2 =5.5533, P=0.0184) and significantly fewer needle passes (1.0[1.0-2.0] vs. 2.0[1.0-3.0], χ 2 =-2.6094, P=0.0091). There was no significant difference between the groups in the procedure time (368[304-573] vs. 478[324-79]s, Z=-1.7690, P=0.0769). Complications occurred in both groups, but the incidence was significantly lower in the CSLA group than in the DNTP group (6.7% vs. 22.2%, χ2 =4.4056, P=0.0358).
CONCLUSIONS
Ultrasound-guided internal jugular vein catheterization by the CSLA method is effective and safe. The CSLA method may be superior to the DNTP technique in premature newborns.",2020,"Complications occurred in both groups, but the incidence was significantly lower in the CSLA group than in the DNTP group (6.7% vs. 22.2%, χ2 =4.4056, P=0.0358).
","['90 premature newborns (gestational age <37 weeks and <28 d after birth) who were scheduled for surgery were included in this study', 'premature newborns in comparison with the DNTP technique', 'All enrolled premature newborns', 'premature infants requiring surgery', 'premature newborns']","['combined short- and long-axis (CSLA) internal jugular vein catheterization', 'Combined short- and long-axis method for internal jugular vein catheterization', 'CSLA', 'DNTP', 'Ultrasound-guided dynamic needle tip positioning (DNTP', 'CSLA group and the DNTP']","['procedure time', 'higher first-attempt success rate', 'Complications', 'puncture success rate, total success rate, procedure time, number of needle passes, occurrence of complications', 'Total success', 'needle passes']","[{'cui': 'C0233315', 'cui_str': 'Premature birth of newborn'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",90.0,0.0343837,"Complications occurred in both groups, but the incidence was significantly lower in the CSLA group than in the DNTP group (6.7% vs. 22.2%, χ2 =4.4056, P=0.0358).
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Tu', 'Affiliation': ""Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Lifei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Yanzhe', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': ""Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.""}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13728']
2073,33147368,Ivabradine as adjuvant treatment for chronic heart failure.,"BACKGROUND
Chronic heart failure is one of the most common medical conditions, affecting more than 23 million people worldwide. Despite established guideline-based, multidrug pharmacotherapy, chronic heart failure is still the cause of frequent hospitalisation, and about 50% die within five years of diagnosis.
OBJECTIVES
To assess the effectiveness and safety of ivabradine in individuals with chronic heart failure.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, and CPCI-S Web of Science in March 2020. We also searched ClinicalTrials.gov and the WHO ICTRP. We checked reference lists of included studies. We did not apply any time or language restrictions.
SELECTION CRITERIA
We included randomised controlled trials in which adult participants diagnosed with chronic heart failure were randomly assigned to receive either ivabradine or placebo/usual care/no treatment. We distinguished between type of heart failure (heart failure with a reduced ejection fraction or heart failure with a preserved ejection fraction) as well as between duration of ivabradine treatment (short term (< 6 months) or long term (≥ 6 months)).
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion, extracted data, and checked data for accuracy. We calculated risk ratios (RR) using a random-effects model. We completed a comprehensive 'Risk of bias' assessment for all studies. We contacted authors for missing data. Our primary endpoints were: mortality from cardiovascular causes; quality of life; time to first hospitalisation for heart failure during follow-up; and number of days spent in hospital due to heart failure during follow-up. Our secondary endpoints were: rate of serious adverse events; exercise capacity; and economic costs (narrative report). We assessed the certainty of the evidence applying the GRADE methodology.
MAIN RESULTS
We included 19 studies (76 reports) involving a total of 19,628 participants (mean age 60.76 years, 69% male). However, few studies contributed data to meta-analyses due to inconsistency in trial design (type of heart failure) and outcome reporting and measurement. In general, risk of bias varied from low to high across the included studies, with insufficient detail provided to inform judgement in several cases. We were able to perform two meta-analyses focusing on participants with heart failure with a reduced ejection fraction (HFrEF) and long-term ivabradine treatment. There was evidence of no difference between ivabradine and placebo/usual care/no treatment for mortality from cardiovascular causes (RR 0.99, 95% confidence interval (CI) 0.88 to 1.11; 3 studies; 17,676 participants; I 2 = 33%; moderate-certainty evidence). Furthermore, we found evidence of no difference in rate of serious adverse events amongst HFrEF participants randomised to receive long-term ivabradine compared with those randomised to placebo, usual care, or no treatment (RR 0.96, 95% CI 0.92 to 1.00; 2 studies; 17,399 participants; I 2 = 12%; moderate-certainty evidence). We were not able to perform meta-analysis for all other outcomes, and have low confidence in the findings based on the individual studies.
AUTHORS' CONCLUSIONS
We found evidence of no difference in cardiovascular mortality and serious adverse events between long-term treatment with ivabradine and placebo/usual care/no treatment in participants with heart failure with HFrEF. Nevertheless, due to indirectness (male predominance), the certainty of the available evidence is rated as moderate.",2020,We found evidence of no difference in cardiovascular mortality and serious adverse events between long-term treatment with ivabradine and placebo/usual care/no treatment in participants with heart failure with HFrEF.,"['participants with heart failure with a reduced ejection fraction (HFrEF) and long-term ivabradine treatment', 'heart failure (heart failure with a reduced ejection fraction or heart failure with a preserved ejection fraction) as well as between duration of ivabradine treatment (short term (< 6 months) or long term (≥ 6 months', 'participants with heart failure with HFrEF', 'adult participants diagnosed with chronic heart failure', 'chronic heart failure', '19 studies (76 reports) involving a total of 19,628 participants (mean age 60.76 years, 69% male', 'individuals with chronic heart failure']","['Ivabradine', 'ivabradine', 'ivabradine and placebo', 'placebo', 'ivabradine or placebo/usual care/no treatment']","['rate of serious adverse events; exercise capacity; and economic costs (narrative report', 'calculated risk ratios (RR', 'rate of serious adverse events', 'effectiveness and safety', 'cardiovascular mortality and serious adverse events', 'mortality from cardiovascular causes', 'mortality from cardiovascular causes; quality of life; time to first hospitalisation for heart failure during follow-up; and number of days spent in hospital due to heart failure']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",19628.0,0.358367,We found evidence of no difference in cardiovascular mortality and serious adverse events between long-term treatment with ivabradine and placebo/usual care/no treatment in participants with heart failure with HFrEF.,"[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Benstoem', 'Affiliation': 'Department of Intensive Care Medicine, Medical Faculty, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kalvelage', 'Affiliation': 'Department of Intensive Care Medicine, Medical Faculty, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Breuer', 'Affiliation': 'Department of Intensive Care Medicine, Medical Faculty, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Heussen', 'Affiliation': 'Department of Medical Statistics, Medical Faculty RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Marx', 'Affiliation': 'Department of Intensive Care Medicine, Medical Faculty, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stoppe', 'Affiliation': 'Department of Intensive Care Medicine, Medical Faculty, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Brandenburg', 'Affiliation': 'Department of Cardiology, Medical Faculty, University Hospital RWTH Aachen, Aachen, Germany.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013004.pub2']
2074,33147492,Outcome of Laparoscopic Adhesiolysis in Infertile Patients with Pelvic Adhesions Following Cesarean Delivery: A Randomized Clinical Trial.,"OBJECTIVES
To evaluate results of laparoscopic adhesiolysis in patients with post cesarean infertility regards restoration of the fertility and achievement of pregnancy. To identify a group of patients who should primarily be offered laparoscopic adhesiolysis and those who should be treated by IVF.
DESIGN
Randomized prospective clinical trial MATERIALS AND METHODS: 184 patients with secondary infertility diagnosed to have periadnexal and pelvic adhesions, were randomly allocated into two groups: group I (92 cases) treated by laparoscopic adhesiolysis and group II (92 cases) who treated for a year by controlled ovarian stimulation and IUI up to 3 trials. Diagnostic work-up of infertility was carried out denoting normal semen, patent both tubes at HSG, and ovulatory at ovulation testing with normal hormonal profile. The outcomes, cumulative pregnancy rates calculated for each group after one year.
RESULTS
According to the adhesions, the patients classified into 4 groups: 8 cases inoperable, 43 cases with mild type adhesions, 26 cases with moderate type adhesions, and 5 cases with severe type adhesions. The patients followed up postoperatively for year. Overall pregnancy rate 54.35 %. For patients with mild adhesions 76.7%, for patients with moderate adhesions 61.5%, and for patients with severe adhesions 20%. Complications present in (1.57%), cost is (125.7-180.9 $). Over all pregnancy rate was 11.96% in group (II) CONCLUSIONS: laparoscopic adhesiolysis is the method of choice for dealing with mild to moderate periadnexal adhesions after C.S. The pregnancy outcome after lysis of severe periadnexal adhesions is poor. So, such patients are best treated by IVF.",2020,Over all pregnancy rate was 11.96% in group (II) CONCLUSIONS: laparoscopic adhesiolysis is the method of choice for dealing with mild to moderate periadnexal adhesions after C.S.,"['patients with post cesarean infertility regards restoration of the fertility and achievement of pregnancy', '43 cases with mild type adhesions, 26 cases with moderate type adhesions, and 5 cases with severe type adhesions', '184 patients with secondary infertility diagnosed to have periadnexal and pelvic adhesions', 'patients who should primarily be offered laparoscopic adhesiolysis and those who should be treated by IVF', 'Infertile Patients with Pelvic Adhesions Following Cesarean Delivery']","['Laparoscopic Adhesiolysis', 'laparoscopic adhesiolysis']","['pregnancy rate', 'cumulative pregnancy rates', 'Overall pregnancy rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0269230', 'cui_str': 'Secondary female infertility'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0262591', 'cui_str': 'Pelvic adhesions'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0198539', 'cui_str': 'Laparoscopic lysis of adhesions'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0198539', 'cui_str': 'Laparoscopic lysis of adhesions'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",184.0,0.0753657,Over all pregnancy rate was 11.96% in group (II) CONCLUSIONS: laparoscopic adhesiolysis is the method of choice for dealing with mild to moderate periadnexal adhesions after C.S.,"[{'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'E Elgergawy', 'Affiliation': 'Faculty of Medicine, Tanta University, Egypt. Electronic address: dradelali775@gmai.com.'}, {'ForeName': 'Ahmed E', 'Initials': 'AE', 'LastName': 'Elhalwagy', 'Affiliation': 'Faculty of Medicine, Tanta University, Egypt.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'A Salem', 'Affiliation': 'Faculty of Medicine, Tanta University, Egypt.'}, {'ForeName': 'Ayman S', 'Initials': 'AS', 'LastName': 'Dawood', 'Affiliation': 'Faculty of Medicine, Tanta University, Egypt.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101969']
2075,33147541,The effects of nano-curcumin supplementation on Th1/Th17 balance in migraine patients: A randomized controlled clinical trial.,"BACKGROUND
The present study was aimed to evaluate the nano-curcumin supplementation on Th1/Th17 balance by assessment of gene expression and serum level of interferon gamma (IFN-γ) and interleukin-17 (IL-17) in migraine patients.
METHODS
Forty participants with episodic migraine were randomly allocated to receive 80 mg nano-curcumin (n = 20) or placebo (n = 20) in a randomized double-blind clinical trial for two months. The expression of IFN-γ and IL-17 from peripheral blood mononuclear cells and IFN-γ and IL-17 serum levels were measured, using a real-time PCR and ELISA methods, respectively.
RESULTS
Compared to placebo group, two month nano-curcumin supplementation led to a significant reduction in serum levels and expression of IL-17 mRNA (P = 0.006 & 0.04, respectively), while there was no statistical difference regarding serum levels and expression of IFN-γ mRNA.
CONCLUSION
Nano-curcumin supplementation in migraine patients led to a significant reduction in gene expression and plasma levels of IL-17 compared to control group.",2020,"Compared to placebo group, two month nano-curcumin supplementation led to a significant reduction in serum levels and expression of IL-17 mRNA (P = 0.006 & 0.04, respectively), while there was no statistical difference regarding serum levels and expression of IFN-γ mRNA.
","['Forty participants with episodic migraine', 'migraine patients']","['80\xa0mg nano-curcumin', 'nano-curcumin supplementation', 'placebo']","['gene expression and serum level of interferon gamma (IFN-γ) and interleukin-17 (IL-17', 'expression of IFN-γ and IL-17 from peripheral blood mononuclear cells and IFN-γ and IL-17 serum levels', 'gene expression and plasma levels of IL-17', 'Th1/Th17 balance', 'serum levels and expression of IFN-γ mRNA', 'serum levels and expression of IL-17 mRNA']","[{'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}]",40.0,0.297115,"Compared to placebo group, two month nano-curcumin supplementation led to a significant reduction in serum levels and expression of IL-17 mRNA (P = 0.006 & 0.04, respectively), while there was no statistical difference regarding serum levels and expression of IFN-γ mRNA.
","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Djalali', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Abdolahi', 'Affiliation': 'Amir Alam Hospital Complexes, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Hosseini', 'Affiliation': 'Department of Immunology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Miraghajani', 'Affiliation': 'Cancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; The Early Life Research Unit, Academic Division of Child Health, Obstetrics and Gynaecology, And Nottingham Digestive Disease Centre and Biomedical Research Centre, The School of Medicine, University of Nottingham, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Djalali', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: mjalali87@yahoo.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101256']
2076,33148016,Reduction in Revascularization with Icosapent Ethyl: Insights from REDUCE-IT REVASC.,"Background: Patients with elevated triglycerides despite statin therapy have increased risk for ischemic events, including coronary revascularizations. Methods: REDUCE-IT, a multicenter, double-blind, placebo-controlled trial, randomized statin-treated patients with elevated triglycerides (135-499 mg/dL), controlled LDL (41-100 mg/dL), and either established cardiovascular disease or diabetes plus other risk factors to receive icosapent ethyl 4 g daily or placebo. The primary and key secondary composite endpoints were significantly reduced. Prespecified analyses examined all coronary revascularizations, recurrent revascularizations, and revascularization subtypes. Results: A total of 8,179 randomized patients were followed for 4.9 years (median). First revascularizations were reduced to 9.2% (22.5/1000 patient-years) with icosapent ethyl versus 13.3% (33.7/1000 patient-years) with placebo (hazard ratio [HR]=0.66; 95% confidence interval (CI), 0.58-0.76; p<0.0001; number needed to treat [NNT 4.9y ]=24); similar reductions were observed in total (first and subsequent) revascularizations (negative binomial rate ratio [RR] 0.64; 95% CI, 0.56-0.74; p<0.0001), and across elective, urgent, and emergent revascularizations. Icosapent ethyl significantly reduced percutaneous coronary intervention (PCI) (HR=0.68; 95% CI, 0.59-0.79; p<0.0001) and coronary artery bypass grafting (CABG) (HR=0.61; 95% CI, 0.45-0.81; p=0.0005). Conclusions: Icosapent ethyl reduced the need for first and subsequent coronary revascularizations in statin-treated patients with elevated triglycerides and increased cardiovascular risk. To our knowledge, icosapent ethyl is the first non-LDL-lowering treatment that has been shown to reduce CABG in a blinded, randomized trial. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT01492361.",2020,"First revascularizations were reduced to 9.2% (22.5/1000 patient-years) with icosapent ethyl versus 13.3% (33.7/1000 patient-years) with placebo (hazard ratio [HR]=0.66; 95% confidence interval (CI), 0.58-0.76; p<0.0001; number needed to treat [NNT 4.9y ]=24); similar reductions were observed in total (first and subsequent) revascularizations (negative binomial rate ratio [RR] 0.64; 95% CI, 0.56-0.74; p<0.0001), and across elective, urgent, and emergent revascularizations.","[': Patients with elevated triglycerides despite statin therapy have increased risk for ischemic events, including coronary revascularizations', 'patients with elevated triglycerides (135-499 mg/dL), controlled LDL (41-100 mg/dL), and either established cardiovascular disease or diabetes plus other risk factors to receive', 'A total of 8,179 randomized patients were followed for 4.9 years (median']","['icosapent ethyl 4 g daily or placebo', 'placebo']","['First revascularizations', 'percutaneous coronary intervention (PCI', 'coronary artery bypass grafting (CABG', 'cardiovascular risk', 'coronary revascularizations, recurrent revascularizations, and revascularization subtypes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]","[{'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}]",8179.0,0.662263,"First revascularizations were reduced to 9.2% (22.5/1000 patient-years) with icosapent ethyl versus 13.3% (33.7/1000 patient-years) with placebo (hazard ratio [HR]=0.66; 95% confidence interval (CI), 0.58-0.76; p<0.0001; number needed to treat [NNT 4.9y ]=24); similar reductions were observed in total (first and subsequent) revascularizations (negative binomial rate ratio [RR] 0.64; 95% CI, 0.56-0.74; p<0.0001), and across elective, urgent, and emergent revascularizations.","[{'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Peterson', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston MA.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston MA.""}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, AP-HP (Assistance Publique-Hôpitaux de Paris), Hôpital Bichat, FACT (French Alliance for Cardiovascular Trials), INSERM U-1148, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Eliot A', 'Initials': 'EA', 'LastName': 'Brinton', 'Affiliation': 'Utah Lipid Center, Salt Lake City, UT.'}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Jacobson', 'Affiliation': 'Office of Health Promotion and Disease Prevention, Department of Medicine, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Ketchum', 'Affiliation': 'Amarin Pharma, Inc. (Amarin), Bridgewater, NJ.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Juliano', 'Affiliation': 'Amarin Pharma, Inc. (Amarin), Bridgewater, NJ.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Jiao', 'Affiliation': 'Amarin Pharma, Inc. (Amarin), Bridgewater, NJ.'}, {'ForeName': 'Ralph T', 'Initials': 'RT', 'LastName': 'Doyle', 'Affiliation': 'Amarin Pharma, Inc. (Amarin), Bridgewater, NJ.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Granowitz', 'Affiliation': 'Amarin Pharma, Inc. (Amarin), Bridgewater, NJ.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Baim Clinical Research Institute, Boston, MA.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Pinto', 'Affiliation': 'Baim Clinical Research Institute, Boston, MA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston MA.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': 'David Geffen School of Medicine, Lundquist Institute, Torrance, CA.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, ON, Canada.""}, {'ForeName': 'Christie M', 'Initials': 'CM', 'LastName': 'Ballantyne', 'Affiliation': 'Department of Medicine, Baylor College of Medicine; Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.050276']
2077,33148023,Efficacy and safety of Nd:YAG laser vitreolysis for symptomatic vitreous floaters: A randomized controlled trial.,"BACKGROUND
Vitreous floaters are a common and inconvenient phenomena. This study aims to examine the efficacy and safety in treating vitreous floaters using Nd:YAG laser vitreolysis.
METHODS
In this prospective double-blinded randomized clinical trial 24 eyes of twenty-four patients were randomized into intervention with YAG laser vitreolysis and control groups. Primary outcomes were visual disturbance on a 10-point scale, qualitative changes in a 4-level scale, contrast sensitivity measured with the Pelli-Robson table and the National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25). Secondary results included objective change in vitreous opacities, best-corrected visual acuity (BCVA), variation in intraocular pressure (IOP) and other adverse events.
RESULTS
Twenty-one patients (21 eyes; 5 male, 16 female) were enrolled in this study (mean age 62 ± 7.9 years), three were lost during follow-up. In the YAG laser group, the 10-point visual disturbance score improved a mean of 4.7 points ( p < 0.001) compared to the control group that improved 2.1 ( p = 0.09). The YAG laser group reported greater subjectively symptomatic improvement (77%) than controls (25%). NEI VFQ-25 revealed improved general vision (75.8 versus 59.2; p = 0.037) and in mental health at 6 months (84.3 versus 70.3; p = 0.048). There was no significant difference in contrast sensitivity ( p = 0.848) and in IOP ( p = 0.505). No differences in adverse events between groups were identified.
CONCLUSION
Vitreolysis with Nd:YAG laser improves visual results in patients with symptomatic vitreous floaters, without adverse events considered clinically relevant. Other trials with a larger number of participants are required to corroborate these results.",2020,"Vitreolysis with Nd:YAG laser improves visual results in patients with symptomatic vitreous floaters, without adverse events considered clinically relevant.","['symptomatic vitreous floaters', 'patients with symptomatic vitreous floaters', '24 eyes of twenty-four patients', 'Twenty-one patients (21 eyes; 5 male, 16 female) were enrolled in this study (mean age 62\u2009±\u20097.9\u2009years']","['Vitreolysis with Nd:YAG laser', 'YAG laser', 'YAG laser vitreolysis and control groups', 'Nd:YAG laser vitreolysis']","['10-point visual disturbance score', 'mental health', 'efficacy and safety', 'visual results', 'general vision', 'objective change in vitreous opacities, best-corrected visual acuity (BCVA), variation in intraocular pressure (IOP) and other adverse events', 'adverse events', 'Efficacy and safety', 'contrast sensitivity', 'visual disturbance on a 10-point scale, qualitative changes in a 4-level scale, contrast sensitivity measured with the Pelli-Robson table and the National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25', 'subjectively symptomatic improvement']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0016242', 'cui_str': 'Vitreous floaters'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0547030', 'cui_str': 'Visual disturbance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016242', 'cui_str': 'Vitreous floaters'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0456950', 'cui_str': 'Level 4'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",24.0,0.30993,"Vitreolysis with Nd:YAG laser improves visual results in patients with symptomatic vitreous floaters, without adverse events considered clinically relevant.","[{'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Ludwig', 'Affiliation': 'Ophthalmology Department, Instituto de Assistência Médica ao Servidor Publico Estadual de São Paulo (IAMSPE), São Paulo, SP, Brazil.'}, {'ForeName': 'Henrique', 'Initials': 'H', 'LastName': 'Gemelli', 'Affiliation': 'Ophthalmology Department, Instituto de Assistência Médica ao Servidor Publico Estadual de São Paulo (IAMSPE), São Paulo, SP, Brazil.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': 'Nunes', 'Affiliation': 'Ophthalmology Department, Instituto de Assistência Médica ao Servidor Publico Estadual de São Paulo (IAMSPE), São Paulo, SP, Brazil.'}, {'ForeName': 'Pedro D', 'Initials': 'PD', 'LastName': 'Serracarbassa', 'Affiliation': 'Ophthalmology Department, Instituto de Assistência Médica ao Servidor Publico Estadual de São Paulo (IAMSPE), São Paulo, SP, Brazil.'}, {'ForeName': 'Márgara', 'Initials': 'M', 'LastName': 'Zanotele', 'Affiliation': 'Ophthalmology Department, Instituto de Assistência Médica ao Servidor Publico Estadual de São Paulo (IAMSPE), São Paulo, SP, Brazil.'}]",European journal of ophthalmology,['10.1177/1120672120968762']
2078,33148066,A Randomized Controlled Trial of a Community Health Worker Delivered Home-Based Asthma Intervention to Improve Pediatric Asthma Outcomes.,"Objective: The objective of this study was to evaluate the effects of using Community Health Workers (CHWs) to deliver the home-based Wee Wheezers asthma education program on asthma symptoms among children with persistent asthma. Methods: In this randomized controlled trial of 151 children aged 2-9 years with persistent asthma, we assigned 75 to the intervention and 76 to the control. The primary outcome was caregiver-reported asthma symptom days. Secondary outcomes included asthma-related healthcare utilization, caregivers' asthma knowledge, illness perception and management behaviors, MDI-spacer administration technique, and home environmental triggers. Outcomes were collected at baseline, 3-, 6-, 9- and 12-months. A repeated measurements analytic approach with generalized estimating equations was used. To account for missing data, multiple imputation methods were employed. Results: At 3- and 6-months, improvement in symptom days was not significantly different between groups. However, at 9- and 12-months, the reduction in asthma symptom days was 2.15 and 2.31 days more respectively for those in the intervention group compared to the control. Improvements in MDI-spacer technique, knowledge and attitudes were significant throughout follow-up. Improvement in habits regarding MDI use was significant at 3- and 6-months, and asthma routines were improved at 3-months. However, there was no change in asthma-related healthcare utilization or home environmental triggers. Conclusion: Using CHWs to deliver a home-based asthma education program to caregivers of children with persistent asthma led to improvements in symptom days and several secondary outcomes. Expanding the use of CHWs to provide home-based interventions can help reduce disparities in children's health outcomes.",2020,"Improvements in MDI-spacer technique, knowledge and attitudes were significant throughout follow-up.","['151 children aged 2-9 years with persistent asthma, we assigned 75 to the intervention and 76 to the control', 'children with persistent asthma', 'caregivers of children with persistent asthma']","['CHWs to deliver a home-based asthma education program', 'Community Health Worker Delivered Home-Based Asthma Intervention', 'Community Health Workers (CHWs', 'home-based Wee Wheezers asthma education program']","['caregiver-reported asthma symptom days', ""asthma-related healthcare utilization, caregivers' asthma knowledge, illness perception and management behaviors, MDI-spacer administration technique, and home environmental triggers"", 'MDI-spacer technique, knowledge and attitudes', 'asthma routines', 'symptom days', 'reduction in asthma symptom days']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0153064', 'cui_str': 'Western equine encephalitis'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",151.0,0.0818468,"Improvements in MDI-spacer technique, knowledge and attitudes were significant throughout follow-up.","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Jonas', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Cheng-Shiun', 'Initials': 'CS', 'LastName': 'Leu', 'Affiliation': 'Columbia University, Mailman School of Public Health, New York, NY.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Reznik', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1846746']
2079,33148103,Modulation of premotor cortex response to sequence motor learning during escitalopram intake.,"The contribution of selective serotonin reuptake inhibitors to motor learning by inducing motor cortical plasticity remains controversial given diverse findings from positive preclinical data to negative findings in recent clinical trials. To empirically address this translational disparity, we use functional magnetic resonance imaging in a double-blind, randomized controlled study to assess whether 20 mg escitalopram improves sequence-specific motor performance and modulates cortical motor response in 64 healthy female participants. We found decreased left premotor cortex responses during sequence-specific learning performance comparing single dose and steady escitalopram state. Escitalopram plasma levels negatively correlated with the premotor cortex response. We did not find evidence in support of improved motor performance after a week of escitalopram intake. These findings do not support the conclusion that one week escitalopram intake increases motor performance but could reflect early adaptive plasticity with improved neural processing underlying similar task performance when steady peripheral escitalopram levels are reached.",2020,We found decreased left premotor cortex responses during sequence-specific learning performance comparing single dose and steady escitalopram state.,['64 healthy female participants'],['20\u2009mg escitalopram'],"['Escitalopram plasma levels', 'sequence-specific motor performance', 'left premotor cortex responses', 'motor performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0228202', 'cui_str': 'Premotor cortex'}]",64.0,0.323261,We found decreased left premotor cortex responses during sequence-specific learning performance comparing single dose and steady escitalopram state.,"[{'ForeName': 'Eóin N', 'Initials': 'EN', 'LastName': 'Molloy', 'Affiliation': 'Emotion Neuroimaging (EGG) Lab, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Mueller', 'Affiliation': 'Nuclear Magnetic Resonance Methods & Development Group, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Beinhölzl', 'Affiliation': 'Emotion Neuroimaging (EGG) Lab, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Blöchl', 'Affiliation': 'Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Fabian A', 'Initials': 'FA', 'LastName': 'Piecha', 'Affiliation': 'Emotion Neuroimaging (EGG) Lab, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Pampel', 'Affiliation': 'Nuclear Magnetic Resonance Methods & Development Group, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Steele', 'Affiliation': 'Department of Psychology, Concordia University, Montréal, Canada.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Scharrer', 'Affiliation': 'Emotion Neuroimaging (EGG) Lab, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Gergana', 'Initials': 'G', 'LastName': 'Zheleva', 'Affiliation': 'Emotion Neuroimaging (EGG) Lab, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Regenthal', 'Affiliation': 'Division of Clinical Pharmacology, Rudolf-Boehm-Institute of Pharmacology and Toxicology, Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Sehm', 'Affiliation': 'Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Vadim V', 'Initials': 'VV', 'LastName': 'Nikulin', 'Affiliation': 'Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Harald E', 'Initials': 'HE', 'LastName': 'Möller', 'Affiliation': 'Nuclear Magnetic Resonance Methods & Development Group, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Villringer', 'Affiliation': 'Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sacher', 'Affiliation': 'Emotion Neuroimaging (EGG) Lab, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}]",Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism,['10.1177/0271678X20965161']
2080,33148129,Preferences for panic control treatment and panic focused psychodynamic psychotherapy for panic disorder - who chooses which and why?,"Objective: Few studies have examined factors associated with patient's choice of particular psychological treatments. The present study explores possible associations to, and the reasons given for, patient's choice of Panic Control Treatment (PCT) or Panic-Focused Psychodynamic Psychotherapy (PFPP) for Panic Disorder with or without Agoraphobia (PD/A). Method: Both quantitative and qualitative analyses were applied to data obtained from 109 adults with PD/A who were randomized to the Choice condition in the doubly randomized controlled preference trial from which this data are drawn. Results: The strongest associations were between treatment credibility ratings and the treatment choice ( d = -1.00 and 1.31, p < .01, for PCT and PFPP respectively). Treatment choice was also moderately associated with patient characteristics, treatment helpfulness beliefs, and learning style. Qualitative analysis revealed that patients gave contrasting reasons for their treatment choice; either a focus on the present, symptom reduction and problem-solving for those who chose PCT or a focus on the past, symptom understanding and reflection for those who chose PFPP. Conclusions: When offered a choice between two evidence-based psychotherapies for PD/A, the resulting choice was primarily a function of the patient's beliefs about the chosen therapy, its potential for success, and their preferred learning style.",2020,"The strongest associations were between treatment credibility ratings and the treatment choice ( d = -1.00 and 1.31, p < .01, for PCT and PFPP respectively).","['109 adults with PD/A who', 'Panic Disorder with or without Agoraphobia (PD/A']","['psychodynamic psychotherapy', 'Panic Control Treatment (PCT) or Panic-Focused Psychodynamic Psychotherapy (PFPP']","['patient characteristics, treatment helpfulness beliefs, and learning style']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}]","[{'cui': 'C1261382', 'cui_str': 'Psychodynamic psychotherapy'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",109.0,0.0228113,"The strongest associations were between treatment credibility ratings and the treatment choice ( d = -1.00 and 1.31, p < .01, for PCT and PFPP respectively).","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Svensson', 'Affiliation': 'Department of Psychology, Lund University, Lund, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nilsson', 'Affiliation': 'Department of Psychology, Lund University, Lund, Sweden.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Perrin', 'Affiliation': 'Department of Psychology, Lund University, Lund, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': 'Department of Psychology, Lund University, Lund, Sweden.'}, {'ForeName': 'Gardar', 'Initials': 'G', 'LastName': 'Viborg', 'Affiliation': 'Department of Psychology, Lund University, Lund, Sweden.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Sandell', 'Affiliation': 'Department of Psychology, Lund University, Lund, Sweden.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1839686']
2081,33148218,Children's physical activity level and sedentary behaviour in Norwegian early childhood education and care: effects of a staff-led cluster-randomised controlled trial.,"BACKGROUND
A growing body of evidence suggest that the children's physical activity (PA) level in early childhood education and care (ECEC) settings are insufficient. Since most children attend ECEC settings for many hours on most days of the week, and these institutions reach children across the socioeconomic spectrum, the ECEC settings may serve as an ideal avenue for increasing physical activity level, reduce sedentary time and enhance the overall health of young children. This paper investigates the effectiveness of the ""Active Kindergarten - Active Children"" study to increase children's PA level and reduce sedentary time within the ECEC setting.
METHODS
Accelerometers were used to asses PA and sedentary time. A total of 116 three to four-year olds took part in a randomised controlled trial in 11 ECEC settings. Participants were cluster-randomised, by ECEC setting, to either a 12 week staff-led and expert-supported intervention or a waiting list control group.
RESULTS
The intervention group increased time spent in moderate- and vigorous intensity PA by 10 min/day (95% CI = 3, 18; P = 0.01), took 1909 more steps per day (95% CI = 1130, 2688; P < 0.01) and reduced sedentary time with 14 min/day (95% CI = - 27, - 1; P = 0.04) compared to the control group. The intervention group had a 2.4 higher odds (95% CI = 1.05, 5.7; P = 0.04) of meeting the PA recommendations compared to the control group at follow-up.
CONCLUSIONS
Our results show that a flexible staff-led and expert-supported multicomponent PA intervention can increase total PA level, moderate- and vigorous intensity PA and reduce time spent sedentary in three to four-year old children during their stay in ECEC settings.
TRIAL REGISTRATION
The trial was retrospectively registered on September 19, 2020 and available online at ClinicalTrials.gov: No. NCT04555746 .",2020,"The intervention group had a 2.4 higher odds (95% CI = 1.05, 5.7; P = 0.04) of meeting the PA recommendations compared to the control group at follow-up.
","['A total of 116 three to four-year olds took part in a randomised controlled trial in 11 ECEC settings', 'September 19, 2020 and available online at ClinicalTrials.gov']","['12\u2009week staff-led and expert-supported intervention or a waiting list control group', 'multicomponent PA intervention']","['reduced sedentary time', 'total PA level, moderate- and vigorous intensity PA and reduce time spent sedentary', 'time spent in moderate- and vigorous intensity PA', ""Children's physical activity level and sedentary behaviour""]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",11.0,0.168765,"The intervention group had a 2.4 higher odds (95% CI = 1.05, 5.7; P = 0.04) of meeting the PA recommendations compared to the control group at follow-up.
","[{'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Andersen', 'Affiliation': 'Faculty of Humanities, Sports and Educational Science, University of South-Eastern Norway, Horten, Norway. eivind.andersen@usn.no.'}, {'ForeName': 'Steinar', 'Initials': 'S', 'LastName': 'Øvreås', 'Affiliation': 'Faculty of Humanities, Sports and Educational Science, University of South-Eastern Norway, Horten, Norway.'}, {'ForeName': 'Kari Anne', 'Initials': 'KA', 'LastName': 'Jørgensen', 'Affiliation': 'Faculty of Humanities, Sports and Educational Science, University of South-Eastern Norway, Horten, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Borch-Jenssen', 'Affiliation': 'Sandefjord Municipality, Sandefjord, Norway.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Moser', 'Affiliation': 'Faculty of Humanities, Sports and Educational Science, University of South-Eastern Norway, Horten, Norway.'}]",BMC public health,['10.1186/s12889-020-09725-y']
2082,33148247,"Effects of a work-related stress model based mental health promotion program on job stress, stress reactions and coping profiles of women workers: a control groups study.","BACKGROUND
Work-related stress and its detrimental effects on human health have rapidly increased during the past several years. It causes many different stress reactions, related diseases and unhealthy behavior among workers, but especially women workers. Thus, the aim of this study was to examine the effects of the work-related stress model based Workplace Mental Health Promotion Programme on the job stress, social support, reactions, salivary immunoglobulin A and Cortisol levels, work absenteeism, job performance and coping profiles of women workers.
METHODS
This study had a ""pre-test post-test non-equivalent control groups"" design and included 70 women workers (35 in each study group) selected by randomized sampling from two factories. The programme was delivered as an intervention including 12 weeks of follow-up. Reminder messages, videos, and WhatsApp texts were used at the follow-up stage. The research measurements were; the assessment form, the Brief Job Stress Questionnaire, the Brief Coping Profile Scale, salivary ELISA kits, and a self-reported check-list.
RESULTS
There were no differences in sociodemographic characteristics, general health or working conditions between the Intervention and control groups(p > .05). Three months after the intervention, there was a significant decrease in job stress(p ≤ .001), physical and mental reactions' scores(p ≤ .001) and work absenteeism(p < .05), and there was an increase in job performance(p < .05), social support(p ≤ .001) among the intervention group. The programme showed positive effects on coping profiles(p < .05). After the intervention salivary-cortisol and IgA levels showed a statistically significant decrease(p < .05). A majority of effect sizes were very large (η p 2 > .14).
CONCLUSIONS
Work-ProMentH was found to be effective and useful in job stress management and promotion of effective coping profiles. It enables its users to holistically assess worker stress and to plan and examine intervention programmes via a systematic approach. There is a need for more empirical studies that may support the data of the present study, but it is thought that the intervention can be maintained for the long-term. We recommend that occupational health professionals at workplaces should consider using this model-based cost-effective intervention, which seems easy and practical to apply in real-life situations.
TRIAL REGISTRATION
ISRCTN registration ID: ISRCTN14333710 (2020/10/03, retrospective registration).",2020,"Three months after the intervention, there was a significant decrease in job stress(p ≤ .001), physical and mental reactions' scores(p ≤ .001) and work absenteeism(p < .05), and there was an increase in job performance(p < .05), social support(p ≤ .001) among the intervention group.","['women workers', '70 women workers (35 in each study group) selected by randomized sampling from two factories']","['work-related stress model based Workplace Mental Health Promotion Programme', 'work-related stress model based mental health promotion program']","['job stress, stress reactions and coping profiles', 'Brief Job Stress Questionnaire, the Brief Coping Profile Scale, salivary ELISA kits, and a self-reported check-list', 'sociodemographic characteristics, general health or working conditions', 'job stress, social support, reactions, salivary immunoglobulin A and Cortisol levels, work absenteeism, job performance and coping profiles of women workers', ""job stress(p\u2009≤\u2009.001), physical and mental reactions' scores(p""]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0442614', 'cui_str': 'Factory'}]","[{'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0016664', 'cui_str': 'Stress fracture'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443735', 'cui_str': 'Salivary immunoglobulin A'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C3887623', 'cui_str': 'Job Performance'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",70.0,0.0347153,"Three months after the intervention, there was a significant decrease in job stress(p ≤ .001), physical and mental reactions' scores(p ≤ .001) and work absenteeism(p < .05), and there was an increase in job performance(p < .05), social support(p ≤ .001) among the intervention group.","[{'ForeName': 'Ozlem Koseoglu', 'Initials': 'OK', 'LastName': 'Ornek', 'Affiliation': 'Occupational and Environmental Epidemiology & NetTeaching Unit, Institute and Clinic for Occupational, Social and Environmental Medicine, University Hospital, LMU, Ziemssenstr. 1, 80336, Munich, Germany. ozlem.koseoglu62@gmail.com.'}, {'ForeName': 'Melek Nihal', 'Initials': 'MN', 'LastName': 'Esin', 'Affiliation': 'Department of Public Health Nursing, İstanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing, İstanbul Üniversitesi Florence Nightingale Hemşirelik Fakültesi, Abide-i Hürriyet Caddesi, Şişli/İstanbul, Turkey.'}]",BMC public health,['10.1186/s12889-020-09769-0']
2083,33148299,Evaluation of the efficacy and safety of fire needle compared to filiform needle on knee osteoarthritis: study protocol for a randomized controlled trial.,"BACKGROUND
Knee osteoarthritis is a common clinical chronic degenerative disease associated with high morbidity and long-term disability. Previous studies have confirmed the efficacy of acupuncture on knee osteoarthritis. Fire needle acupuncture is a combination of heat and acupuncture, which may be more effective than the commonly used filiform needle acupuncture. This study is designed as a randomized controlled trial to evaluate the efficacy and safety of fire needle acupuncture compared to filiform needle acupuncture in knee osteoarthritis patients.
METHODS AND ANALYSIS
This is a prospective randomized controlled superiority clinical trial to evaluate the efficacy and safety of fire needle acupuncture compared to filiform needle acupuncture for knee osteoarthritis. A total of 100 participants will be randomly assigned to two different groups. Participants will receive fire needle acupuncture treatment in the fire needle group, while participants in the filiform needle group will be treated with a filiform needle at the same acupuncture points as the fire needle group. All participants will receive 6 weeks of treatment (2 times per week). The primary outcome is the change of the Western Ontario and McMaster Universities Osteoarthritis Index, and the secondary outcomes include the change of the visual analog scale and 12-item Short Form Health Survey from baseline to endpoint.
ETHICS AND DISSEMINATION
Ethical approval of this study was granted by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University (2018SB-066). Written informed consent will be obtained from all participants. Outcomes of the trial will be disseminated through peer-reviewed publications.
TRIAL REGISTRATION
Chinese Clinical Trial Registry ChiCTR1800019579 . Registered on November 18, 2018.",2020,"Fire needle acupuncture is a combination of heat and acupuncture, which may be more effective than the commonly used filiform needle acupuncture.","['100 participants', 'knee osteoarthritis', 'Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University (2018SB-066', 'knee osteoarthritis patients']","['filiform needle', 'fire needle acupuncture', 'fire needle acupuncture treatment', 'acupuncture', 'fire needle', 'filiform needle acupuncture', 'filiform needle group will be treated with a filiform needle at the same acupuncture points as the fire needle group']","['efficacy and safety', 'change of the Western Ontario and McMaster Universities Osteoarthritis Index, and the secondary outcomes include the change of the visual analog scale and 12-item Short Form Health Survey']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332226', 'cui_str': 'Filiform'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0181956', 'cui_str': 'Acupuncture needle'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",100.0,0.0793324,"Fire needle acupuncture is a combination of heat and acupuncture, which may be more effective than the commonly used filiform needle acupuncture.","[{'ForeName': 'Yuanjie', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China.'}, {'ForeName': 'Huilin', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China.'}, {'ForeName': 'Shaosong', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': 'Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China.'}, {'ForeName': 'Yuanbo', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China.'}, {'ForeName': 'Yizhan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China.'}, {'ForeName': 'Jingqing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China. sjq100037@sina.com.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': 'Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China. alicef531@163.com.'}]",Trials,['10.1186/s13063-020-04827-9']
2084,33148308,The rescue intervention strategy for asthma patients under severe air pollution: a protocol for a single-centre prospective randomized controlled trial.,"BACKGROUND
Asthma is a common chronic airway inflammatory disease. Exacerbations of asthma not only accelerate the progression of the disease but also increase the incidence of hospitalization and death. Studies have shown that air pollution is a high-risk factor for asthma exacerbations. However, few treatment strategies have been recommended to reduce the risk of severe air pollution-related asthma exacerbations.
METHODS/DESIGN
This is a single-centre, prospective, randomized and standard treatment parallel control clinical trial. Seventy-two asthma patients in the nonexacerbation stage according to GINA guidelines 2017 will be recruited and randomized into the rescue intervention strategy (RIS) group and control group. Original treatments for the participants will include no use of inhaled medicine, the use of short-acting β-agonists (SABA) on demand or the use of budesonide/formoterol (160 μg/4.5 μg/dose, 1-2 dose/time, b.i.d.). The rescue intervention strategy for the RIS group will be budesonide/formoterol plus the original treatment until the severe pollution ends (air quality index, AQI < 200). The control group will maintain the original treatment. The follow-up observation period will last 1 year. The primary outcome is the frequency of asthma exacerbations per year. Secondary outcomes include the mean number of unplanned outpatient visits, emergency visits, hospitalizations, medical costs and mortality caused by asthma exacerbations per patient per year.
DISCUSSION
The results of this trial will provide a novel strategy to guide clinical practice in decreasing the risk of asthma exacerbations under severe air pollution.
TRIAL REGISTRATION
ChiCTR ChiCTR1900026757 . Registered on 20 October 2019-retrospectively registered.",2020,"Secondary outcomes include the mean number of unplanned outpatient visits, emergency visits, hospitalizations, medical costs and mortality caused by asthma exacerbations per patient per year.
","['asthma patients under severe air pollution', 'Seventy-two asthma patients in the nonexacerbation stage according to GINA guidelines 2017 will be recruited and randomized into the']","['budesonide/formoterol', 'rescue intervention strategy (RIS) group and control group']","['incidence of hospitalization and death', 'frequency of asthma exacerbations per year', 'mean number of unplanned outpatient visits, emergency visits, hospitalizations, medical costs and mortality caused by asthma exacerbations per patient per year']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",72.0,0.221577,"Secondary outcomes include the mean number of unplanned outpatient visits, emergency visits, hospitalizations, medical costs and mortality caused by asthma exacerbations per patient per year.
","[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Junjun', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Peking University First Hospital, Beijing, 100034, China. jaglpc@126.com.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Cuiyan', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Scientific Research, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Guangfa', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Peking University First Hospital, Beijing, 100034, China. wangguangfa@hotmail.com.'}]",Trials,['10.1186/s13063-020-04830-0']
2085,33152448,Results of the PROPINE randomized controlled study suggest tapering of prednisone treatment for relapses of steroid sensitive nephrotic syndrome is not necessary in children.,"Corticosteroid-related toxicity in children with steroid-sensitive nephrotic syndrome is primarily related to the cumulative dose of prednisone. To optimize treatment of relapses, we conducted the PROPINE study, a multicentric, open-label, randomized, superiority trial. Seventy-eight relapsing children aged 3-17 years who had not received steroid-sparing medications during the previous 12 months were randomized to receive, from day five after remission, either 18 doses of 40 mg/m 2 of prednisone on alternate days (short arm), or the same cumulative dose tapered over double the time (long arm). Patients were monitored with an ad-hoc smartphone application, allowing daily reporting. The primary outcome was the six-month relapse rate at which time, 23/40 and 16/38 patients had relapsed in the long and short arms, respectively (no significant difference). Additionally, 40/78 patients were also enrolled in a secondary crossover study and were allocated to the opposite arm. Altogether, at six months, the relapse rate was 32/40 and 28/40 in the long and short arms, respectively (no significant difference). A post-hoc analysis excluding 30 patients treated with low-dose prednisone maintenance therapy failed to show significant differences between the two arms. No differences in adverse events, blood pressure and weight gain were observed. Thus, our data do not support the prescription of prolonged tapering schedules for relapses of steroid-sensitive nephrotic syndrome in children.",2020,"No differences in adverse events, blood pressure and weight gain were observed.","['40/78 patients', 'children with steroid-sensitive nephrotic syndrome', 'Seventy-eight relapsing children aged 3-17 years who had not received steroid-sparing medications during the previous 12 months']",['prednisone'],"['relapse rate', 'six-month relapse rate', 'adverse events, blood pressure and weight gain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0403396', 'cui_str': 'Steroid-sensitive nephrotic syndrome'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",78.0,0.170087,"No differences in adverse events, blood pressure and weight gain were observed.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gargiulo', 'Affiliation': ""Division of Nephrology and Dialysis, Department of Pediatric Subspecialties, Bambino Gesù Children's Hospital-IRCCS, Rome, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Massella', 'Affiliation': ""Division of Nephrology and Dialysis, Department of Pediatric Subspecialties, Bambino Gesù Children's Hospital-IRCCS, Rome, Italy.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ruggiero', 'Affiliation': ""Division of Nephrology and Dialysis, Department of Pediatric Subspecialties, Bambino Gesù Children's Hospital-IRCCS, Rome, Italy.""}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Ravà', 'Affiliation': ""Unit of Clinical Pathways and Epidemiology, Medical Direction, Bambino Gesù Children's Hospital-IRCCS, Rome, Italy.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ciofi Degli Atti', 'Affiliation': ""Unit of Clinical Pathways and Epidemiology, Medical Direction, Bambino Gesù Children's Hospital-IRCCS, Rome, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Materassi', 'Affiliation': ""Nephrology and Dialysis Unit, Meyer Children's Hospital, Florence, Italy.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Lugani', 'Affiliation': 'Division of Nephrology, Dialysis, Transplantation, Istituto G. Gaslini-IRCCS, Genoa, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Benetti', 'Affiliation': ""Pediatric Nephrology, Dialysis and Transplant Unit, Department of Women's and Children's Health, University Hospital of Padua, Padua, Italy.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Morello', 'Affiliation': ""Pediatric Nephrology, Dialysis and Transplant Unit, Fondazione Ca' Granda IRCCS, Policlinico di Milano, Milano, Italy.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Molino', 'Affiliation': ""Pediatric Nephrology and Dialysis Unit, Santobono Children's Hospital, Naples, Italy.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Mattozzi', 'Affiliation': 'Pediatric Nephrology Unit, Regina Margherita Hospital, City of Health and Science, Turin, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pennesi', 'Affiliation': 'Department of Pediatrics, Institute for Maternal and Child Health-IRCCS Burlo Garofolo, Trieste, Italy.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Maringhini', 'Affiliation': 'Pediatric Department, ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione), Palermo, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pasini', 'Affiliation': ""Nephrology and Dialysis Unit, Department of Pediatrics, Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gianoglio', 'Affiliation': 'Pediatric Nephrology Unit, Regina Margherita Hospital, City of Health and Science, Turin, Italy.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Pecoraro', 'Affiliation': ""Pediatric Nephrology and Dialysis Unit, Santobono Children's Hospital, Naples, Italy.""}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Montini', 'Affiliation': ""Pediatric Nephrology, Dialysis and Transplant Unit, Fondazione Ca' Granda IRCCS, Policlinico di Milano, Milano, Italy; Giuliana and Bernardo Caprotti Chair of Pediatrics, Department of Clinical Sciences and Community Health, University of Milano, Milano, Italy.""}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Murer', 'Affiliation': ""Pediatric Nephrology, Dialysis and Transplant Unit, Department of Women's and Children's Health, University Hospital of Padua, Padua, Italy.""}, {'ForeName': 'Gian Marco', 'Initials': 'GM', 'LastName': 'Ghiggeri', 'Affiliation': 'Division of Nephrology, Dialysis, Transplantation, Istituto G. Gaslini-IRCCS, Genoa, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Romagnani', 'Affiliation': ""Nephrology and Dialysis Unit, Meyer Children's Hospital, Florence, Italy.""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Vivarelli', 'Affiliation': ""Division of Nephrology and Dialysis, Department of Pediatric Subspecialties, Bambino Gesù Children's Hospital-IRCCS, Rome, Italy.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Emma', 'Affiliation': ""Division of Nephrology and Dialysis, Department of Pediatric Subspecialties, Bambino Gesù Children's Hospital-IRCCS, Rome, Italy. Electronic address: francesco.emma@opbg.net.""}]",Kidney international,['10.1016/j.kint.2020.09.024']
2086,33152450,"Safety and efficacy of Artemisinin-Piperaquine for treatment of COVID-19: an open-label, non-randomized, and controlled trial.","BACKGROUND
There are no effective therapies for patients with Coronavirus disease-2019 (COVID-19).
METHODS
Forty-one patients with confirmed COVID-19 were enrolled in the study and divided into two groups: artemisinin-piperaquine (AP) group (n=23) and control group (n=18). The primary outcome was the time taken to reach undetectable levels of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) and the percentage of participants with undetectable SARS-CoV-2 on day 7, 10, 14, and 28. The computed tomography (CT) imaging changes within ten days, the corrected QT interval changes, adverse events, and abnormal laboratory parameters were the secondary outcomes.
RESULTS
The mean time to reach undetectable viral RNA (mean± standard deviation) was 10.6±1.1 days (95% confidence interval [CI]: 8.4-12.8) for AP group and 19.3±2.1 days (95% CI: 15.1-23.5) for the control group. The percentage of patients with undetectable viral RNA on day 7, 10, 14, 21, and 28 were 26.1%, 43.5%, 78.3%, 100%, and 100%, respectively, in the AP group and 5.6%, 16.7%, 44.4%, 55.6% and 72.2%, respectively, in the control group. The CT imaging within ten days post-treatment showed no significant differences between the two groups (p>0.05). Both groups had mild adverse events.
CONCLUSIONS
In patients with mild to moderate COVID-19, the time to reach undetectable SARS-CoV-2 was significantly shorter in the AP group than that in the control group. However, physicians should consider the QT interval changes before using AP.",2020,The CT imaging within ten days post-treatment showed no significant differences between the two groups (p>0.05).,"['patients with Coronavirus disease-2019 (COVID-19', 'Forty-one patients with confirmed COVID-19 were enrolled in the study and divided into two groups', 'group (n=23) and control group (n=18']","['artemisinin-piperaquine (AP', 'Artemisinin-Piperaquine']","['mild adverse events', 'time to reach undetectable SARS-CoV-2', 'Safety and efficacy', 'time taken to reach undetectable levels of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) and the percentage of participants with undetectable SARS-CoV-2', 'corrected QT interval changes, adverse events, and abnormal laboratory parameters', 'percentage of patients with undetectable viral RNA', 'mean time to reach undetectable viral RNA (mean± standard deviation', 'QT interval changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035736', 'cui_str': 'Viral RNA'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",41.0,0.0774791,The CT imaging within ten days post-treatment showed no significant differences between the two groups (p>0.05).,"[{'ForeName': 'Guoming', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Institution of Science and Technology Park, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, People's Republic of China. Electronic address: liguoming2015@sina.cn.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Yuan', 'Affiliation': ""Department of Intensive Medicine, Hongqi Hospital affiliated of Mudanjiang Medical University, Mudanjiang, Heilongjiang, People's Republic of China. Electronic address: 13945389921@163.com.""}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Intensive Medicine, Hongqi Hospital affiliated of Mudanjiang Medical University, Mudanjiang, Heilongjiang, People's Republic of China. Electronic address: soslihaihong@163.com.""}, {'ForeName': 'Changsheng', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': ""Institution of Science and Technology Park, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, People's Republic of China; Artemisinin Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. Electronic address: dcs19811202@163.com.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Artemisinin Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. Electronic address: 15603058869@163.com.""}, {'ForeName': 'Yexiao', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""Artemisinin Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. Electronic address: tangyx7@163.com.""}, {'ForeName': 'Hongying', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Institution of Science and Technology Park, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, People's Republic of China. Electronic address: zhhy0919@163.com.""}, {'ForeName': 'Weisheng', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': ""Artemisinin Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. Electronic address: yuwayson@163.com.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': ""Institution of Science and Technology Park, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, People's Republic of China. Electronic address: xuqin@gzucm.edu.cn.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': ""Artemisinin Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. Electronic address: 20191113285@stu.gzucm.edu.cn.""}, {'ForeName': 'Yueming', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': ""Institution of Science and Technology Park, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, People's Republic of China. Electronic address: yunyueming0801@163.com.""}, {'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Institution of Science and Technology Park, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, People's Republic of China. Electronic address: carmen_guo2013@163.com.""}, {'ForeName': 'Chunming', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': ""Department of Intensive Medicine, Hongqi Hospital affiliated of Mudanjiang Medical University, Mudanjiang, Heilongjiang, People's Republic of China. Electronic address: 13946330155@163.com.""}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': ""Department of Surgical Intensive Care Unit, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China. Electronic address: carlg@163.net.""}, {'ForeName': 'Fengjie', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': ""Department of Intensive Medicine, Hongqi Hospital affiliated of Mudanjiang Medical University, Mudanjiang, Heilongjiang, People's Republic of China. Electronic address: mdjxfj1971@126.com.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': ""Institution of Science and Technology Park, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, People's Republic of China; Artemisinin Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. Electronic address: songjp@gzucm.edu.cn.""}]",International journal of antimicrobial agents,['10.1016/j.ijantimicag.2020.106216']
2087,33152467,Ethnic pharmacokinetic comparison of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) between Asian and Western healthy subjects.,"BACKGROUND
The Phase III KRONOS study (NCT02497001) found the fixed-dose combination triple therapy budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) to be efficacious and well tolerated versus corresponding dual therapies in patients with moderate-to-very severe COPD from North America, China and Japan. However, pharmacokinetic (PK) studies of other drugs have shown that ethnic factors (e.g. genetic factors affecting drug metabolism) can affect the bioavailability of drugs which may impact upon efficacy and safety outcomes.
METHODS
This was a post-hoc analysis of data from four randomised, double-blind Phase I studies of BGF MDI 320/18/9.6 μg and 160/18/9.6 μg in Chinese (NCT03075267), Japanese (NCT02197975) and Western (NCT01980615, NCT02189304) healthy subjects. PK properties (area under the plasma concentration-time curve 0-12 h post-dose [AUC 0-12 ] and maximum plasma concentration, [C max ]) were recorded following single and repeated dosing of BGF MDI 320/18/9.6 μg or 160/18/9.6 μg. Potential ethnic differences in the PK properties of budesonide, glycopyrrolate and formoterol in Chinese, Japanese and Western healthy subjects were derived by non-compartmental analysis, and ethnic insensitivity factors evaluated based on criteria from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Guideline E5 Ethnic Factors in the Acceptability of Foreign Clinical Data.
RESULTS
The analyses included data from 64 Chinese, 31 Japanese and 169 Western subjects. Overall, PK properties following single or repeated dosing of BGF MDI were similar across Chinese, Japanese and Western subjects. After single dosing at either dose level, AUC 0-12 and C max for budesonide, glycopyrrolate and formoterol appeared generally similar for Asian (Chinese and Japanese) versus Western subjects, with most geometric least squares mean ratios within the range of 0.92-1.22. The exception was that C max for glycopyrrolate was slightly lower in Asian versus Western subjects (0.6-0.7). Of the 10 ethnic insensitivity factors evaluated, six were met for budesonide, nine for glycopyrrolate and nine for formoterol, suggesting that BGF MDI can be classified as an ethnically insensitive drug.
CONCLUSIONS
Overall, these analyses suggest no appreciable ethnic differences in the PK of BGF MDI across Chinese, Japanese and Western healthy subjects.",2020,"Overall, PK properties following single or repeated dosing of BGF MDI were similar across Chinese, Japanese and Western subjects.","['Chinese, Japanese and Western healthy subjects', '64 Chinese, 31 Japanese and 169 Western subjects', 'healthy subjects', 'Asian and Western healthy subjects', 'patients with moderate-to-very severe COPD from North America, China and Japan']","['budesonide, glycopyrrolate and formoterol', 'budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI', 'glycopyrrolate']","['Overall, PK properties', 'PK properties (area under the plasma concentration-time curve', 'maximum plasma concentration, [C max ']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",,0.105493,"Overall, PK properties following single or repeated dosing of BGF MDI were similar across Chinese, Japanese and Western subjects.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'AstraZeneca, Liangjing Rd, Pudong Xinqu, Shanghai Shi, China. Electronic address: elaine.huang@astrazeneca.com.'}, {'ForeName': 'Pryseley Nkouibert', 'Initials': 'PN', 'LastName': 'Assam', 'Affiliation': 'AstraZeneca, Liangjing Rd, Pudong Xinqu, Shanghai Shi, China. Electronic address: pryseleyassam.assamnkouibert@astrazeneca.com.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'AstraZeneca, Liangjing Rd, Pudong Xinqu, Shanghai Shi, China. Electronic address: ryan.feng@astrazeneca.com.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Su', 'Affiliation': 'AstraZeneca, Liangjing Rd, Pudong Xinqu, Shanghai Shi, China. Electronic address: rong.su@astrazeneca.com.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'AstraZeneca, 4222 Emperor Blvd, Suite 560, Durham, NC, 27703, USA. Electronic address: paul.dorinsky1@astrazeneca.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gillen', 'Affiliation': 'AstraZeneca, One MedImmune Way, Gaithersburg, MD, 20878, USA. Electronic address: michael.gillen@astrazeneca.com.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101976']
2088,33152520,Self-rehabilitation combined with botulinum toxin to improve arm function in people with chronic stroke. A randomized controlled trial.,"BACKGROUND
Botulinum toxin injection (BTI) reduces muscle hyperactivity but its effect on active upper limb function is limited. Intensive rehabilitation could optimize the effects; however, outpatient post-stroke rehabilitation is usually not intensive. One solution could be self-rehabilitation.
OBJECTIVES
The aim of this randomized controlled trial was to determine the effects of a self-rehabilitation program combined with BTI on upper limb function in individuals with chronic hemiparesis.
METHODS
Thirty-three outpatients were randomly allocated to receive either BTI + self-rehabilitation (R group: n=17) or BTI alone (C group: n=16). Outcomes evaluated just before the BTI and 4 weeks later included: Wolf Motor Function Test (WMFT time - Primary Outcome), Action Research Arm Test, fatigue and quality of life.
RESULTS
Change in WMFT was not different between groups at 4 weeks (WMFT time: -14% for R group, -4 % for C group. WFMT score: +12 % for R group, 0 % in C group). WFMT time and score improved significantly (-14 %, p=0.01 and +12 %, p=0.02 respectively) in the R group only. In addition, the proportion of patients with improved WMFT time and scores was higher in the R group (71% improved score, 77% improved time, C group 43% improved score, 50% improved time). Passive range of shoulder flexion (p=0.03) and wrist extension (p=0.01) also improved only in the R group. No other variables changed significantly. Compliance was excellent; average daily training time was greater than that prescribed.
CONCLUSIONS
The addition of a self-rehabilitation program to BTI did not significantly improve functional outcomes more than BTI alone, however movement quality and speed only improved in the self-rehabilitation group. Participants in the self-rehabilitation group trained more than they were asked to, suggesting they found the program worthwhile. These clinically relevant findings justify larger-scale studies into the effects of self-rehabilitation to enhance the effects of BTI.",2020,Passive range of shoulder flexion (p=0.03) and wrist extension (p=0.01) also improved only in the R group.,"['Thirty-three outpatients', 'individuals with chronic hemiparesis', 'people with chronic stroke']","['BTI alone', 'Self-rehabilitation combined with botulinum toxin', 'Botulinum toxin injection (BTI', 'self-rehabilitation program combined with BTI', 'BTI + self-rehabilitation']","['Passive range of shoulder flexion', 'functional outcomes', 'WFMT score', 'WMFT time and scores', 'Compliance was excellent; average daily training time', 'WFMT time and score', 'wrist extension', 'upper limb function', 'Wolf Motor Function Test (WMFT time - Primary Outcome), Action Research Arm Test, fatigue and quality of life']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0575552', 'cui_str': 'Passive range of shoulder flexion'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",33.0,0.0941886,Passive range of shoulder flexion (p=0.03) and wrist extension (p=0.01) also improved only in the R group.,"[{'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Maulet', 'Affiliation': 'Physiology and Functional Exploration Department, Raymond Poincaré Hospital, APHP, Garches, France; End: icap laboratory, Inserm Unit 1179, UVSQ, France; Paris-Saclay University, UVSQ, Research Unit ERPHAN, 78000, Versailles, France. Electronic address: theo.maulet@aphp.fr.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Pouplin', 'Affiliation': 'Paris-Saclay University, UVSQ, Research Unit ERPHAN, 78000, Versailles, France; New Technologies Platform, Raymond Poincaré Hospital, APHP, Garches, France.'}, {'ForeName': 'Djamel', 'Initials': 'D', 'LastName': 'Bensmail', 'Affiliation': 'End: icap laboratory, Inserm Unit 1179, UVSQ, France; Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital, APHP, Garches, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Zory', 'Affiliation': ""Côte d'Azur University, LAMHESS, Nice, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Roche', 'Affiliation': ""Physiology and Functional Exploration Department, Raymond Poincaré Hospital, APHP, Garches, France; End: icap laboratory, Inserm Unit 1179, UVSQ, France; Côte d'Azur University, LAMHESS, Nice, France.""}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Bonnyaud', 'Affiliation': 'Physiology and Functional Exploration Department, Raymond Poincaré Hospital, APHP, Garches, France; Paris-Saclay University, UVSQ, Research Unit ERPHAN, 78000, Versailles, France.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.10.004']
2089,33148134,Pragmatic application of manipulation versus mobilization to the upper segments of the cervical spine plus exercise for treatment of cervicogenic headache: a randomized clinical trial.,"BACKGROUND
The effectiveness of manipulation versus mobilization for the management of spinal conditions, including cervicogenic headache, is conflicting. However, a pragmatic approach comparing manipulation to mobilization has not been examined in a patient population with cervicogenic headache.
OBJECTIVES
To evaluate the effectiveness of manipulation compared to mobilization applied in a pragmatic fashion for patients with cervicogenic headache.
METHODS
Forty-five (26 females) patients with cervicogenic headache (mean age 47.8 ± SD 16.9 years) were randomly assigned to receive either pragmatically selected manipulation or mobilization. Outcomes were measured at baseline, the second visit, discharge, and 1-month follow-up and included the Neck Disability Index (NDI), Numeric Pain Rating Scale (NPRS), the Headache Impact Test (HIT-6), the Global Rating of Change (GRC), the Patient Acceptable Symptoms Scale (PASS). The primary aim (effects of treatment on disability and pain were examined with a mixed-model analysis of variance (ANOVA), with treatment group (manipulation versus mobilization) as the between subjects variable and time (baseline, 48 hours, discharge and follow-up) as the within subjects variable.
RESULTS
The interaction for the mixed model ANOVA was not statistically significant for NDI (p = 0.91), NPRS (p = 0.81), or HIT (p = 0.89). There was no significant difference between groups for the GRC or PASS.
DISCUSSION AND CONCLUSION
The results suggest that manipulation has similar effects on disability, pain, GRC, and cervical range of motion as mobilization when applied in a pragmatic fashion for patients with cervicogenic headaches.
CLINICALTRIALS.GOV
NCT03919630.",2020,"The interaction for the mixed model ANOVA was not statistically significant for NDI (p = 0.91), NPRS (p = 0.81), or HIT (p = 0.89).","['Forty-five (26 females) patients with cervicogenic headache (mean age 47.8 ±\xa0SD 16.9\xa0years', 'cervicogenic headache', 'patient population with cervicogenic headache', 'patients with cervicogenic headache', 'patients with cervicogenic headaches']","['pragmatically selected manipulation or mobilization', 'cervical spine plus exercise']","['disability, pain, GRC, and cervical range of motion as mobilization', 'NPRS', 'second visit, discharge, and 1-month follow-up and included the Neck Disability Index (NDI), Numeric Pain Rating Scale (NPRS), the Headache Impact Test (HIT-6), the Global Rating of Change (GRC), the Patient Acceptable Symptoms Scale (PASS', 'disability and pain']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458101', 'cui_str': 'Cervicogenic headache'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0627212,"The interaction for the mixed model ANOVA was not statistically significant for NDI (p = 0.91), NPRS (p = 0.81), or HIT (p = 0.89).","[{'ForeName': 'Addison', 'Initials': 'A', 'LastName': 'Lerner-Lentz', 'Affiliation': 'Clinician and Researcher for Pain Relief and Physical Therapy , Havertown, PA, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': ""O'Halloran"", 'Affiliation': 'Director of Physical Therapy for Pain Relief and Physical Therapy , Havertown, PA, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Donaldson', 'Affiliation': 'Program Director for the Doctor of Physical Therapy Program, Tufts University School of Medicine , Boston Mass.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cleland', 'Affiliation': 'Director of Research and Faculty Development, Tufts University School of Medicine , Boston, Mass.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2020.1834322']
2090,33148182,Exercise interveNtion outdoor proJect in the cOmmunitY for older people - results from the ENJOY Seniors Exercise Park project translation research in the community.,"BACKGROUND
Many research studies evaluate physical activity interventions for older people in the community, however relatively few successfully promote maintenance of physical activity beyond the completion of the intervention. This study aimed to implement and evaluate the effects of sustained engagement in physical activity on mental, social and physical health outcomes through the use of the Seniors Exercise Park physical activity program for older people (the ENJOY project).
METHOD
People aged ≥60 years underwent a 12-week structured supervised physical activity program using outdoor exercise park equipment followed by 6 months unstructured independent use of the exercise park. Participants were assessed at baseline, 3 months and 9 months and completed a test battery evaluating physical activity, physical function and health related quality of life measures. Repeated measures ANOVA was used to compare differences between baseline, 3 and 9 months.
RESULTS
Of the 95 participants, 80 (84.2%) completed the 3 months supervised program, and 58 (61%) completed the 9 month assessment (the latter impacted by COVID-19 restrictions). A significant increase in physical activity level was demonstrated following the 12 weeks intervention (p < 0.01). Significant improvements were also demonstrated in all physical function measures (p < 0.01), self-rated quality of life (p < 0.05), wellbeing (p < 0.01), fear of falls (p < 0.01), falls risk (p < 0.01), depressive symptoms (p = 0.01) and loneliness (p = 0.03) at 3 months. At the 9 months follow up, significant improvements from baseline were demonstrated in the frequency, duration and total of physical activity level (p < 0.05), and all physical function measures (p < 0.05), with no decline in these measures from 3 to 9 months. At 9 months, significant changes were observed in the health related quality of life mobility and self care domains with reductions in both fear of falls and falls risk (p < 0.05).
CONCLUSION
The Seniors Exercise Park may be an effective modality for improving and sustaining older people's physical function and wellbeing and can be an important public health infrastructure investment in promoting physical activity for older people. Future work should focus on wider implementation of the program and on scaling up this initiative to achieve public health benefit for the community.
TRIAL REGISTRATION
Trial registration number ACTRN12618001727235, Date of registration 19th October 2018, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375979.",2020,"At the 9 months follow up, significant improvements from baseline were demonstrated in the frequency, duration and total of physical activity level (p < 0.05), and all physical function measures (p < 0.05), with no decline in these measures from 3 to 9 months.","['older people (the ENJOY project', 'older people', 'People aged ≥60\u2009years underwent a 12-week']","['structured supervised physical activity program using outdoor exercise park equipment followed by 6\u2009months unstructured independent use of the exercise park', 'Exercise interveNtion outdoor proJect', 'Seniors Exercise Park physical activity program']","['falls risk', 'fear of falls', 'self-rated quality of life', 'physical function measures', 'health related quality of life mobility and self care domains', 'physical activity, physical function and health related quality of life measures', 'frequency, duration and total of physical activity level', 'fear of falls and falls risk', 'depressive symptoms', 'physical activity level']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]","[{'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0365971,"At the 9 months follow up, significant improvements from baseline were demonstrated in the frequency, duration and total of physical activity level (p < 0.05), and all physical function measures (p < 0.05), with no decline in these measures from 3 to 9 months.","[{'ForeName': 'Pazit', 'Initials': 'P', 'LastName': 'Levinger', 'Affiliation': 'National Ageing Research Institute, Melbourne, Australia. p.levinger@nari.edu.au.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Panisset', 'Affiliation': 'National Ageing Research Institute, Melbourne, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Dunn', 'Affiliation': 'National Ageing Research Institute, Melbourne, Australia.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Haines', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Melbourne, Australia.'}, {'ForeName': 'Briony', 'Initials': 'B', 'LastName': 'Dow', 'Affiliation': 'National Ageing Research Institute, Melbourne, Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Batchelor', 'Affiliation': 'National Ageing Research Institute, Melbourne, Australia.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Biddle', 'Affiliation': 'Centre for Health Research, University of Southern Queensland, Brisbane, Australia.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Duque', 'Affiliation': 'Australian Institute for Musculoskeletal Science (AIMSS), Melbourne Medical School, Melbourne University, Melbourne, Australia.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': 'Rehabilitation, Ageing and Independent Living Research Centre, Monash University, Melbourne, Australia.'}]",BMC geriatrics,['10.1186/s12877-020-01824-0']
2091,33148184,Recruitment and retention of participants from socioeconomically deprived communities: lessons from the Awareness and Beliefs About Cancer (ABACus3) Randomised Controlled Trial.,"BACKGROUND
Recruitment of research participants poses challenges in socioeconomically deprived areas. The Awareness and Beliefs About Cancer (ABACus) phase 3 Randomised Control Trial recruited adult participants from socioeconomically deprived areas using a combined healthcare/community engagement model. We report the strategies used to successfully recruit and retain our trial participant sample.
METHODS
Community and healthcare settings in areas of high socioeconomic deprivation were identified by lay advisors who recruited participants opportunistically or by appointment. Follow-up was done by telephone or post at 2-weeks and 6-months after recruitment, and all participants were offered financial incentives. Qualitative interviews were conducted with lay advisors regarding their experience and reflections.
RESULTS
The lay advisors identified and contacted 107 potential recruitment venues across South and West Yorkshire and South East Wales of which 41.1% (n = 42) were opened for recruitment. A total of 234 participants were recruited, with 91% (n = 212) retention at 2-weeks and 85% (n = 199) at 6-months. Community settings yielded 75% (n = 176) of participants. Participants had a mean age of 61.3 years and 63.3% (n = 148) were female, with 66% (n = 154) resident in the most deprived geographical areas. Lay advisors described recruitment as intensive, although engaging participants was easier in community settings.
CONCLUSIONS
The ABACus3 trial achieved recruitment and high retention with a population that is often ""hard to reach"" or entirely missed in health research. Strategies were specifically tailored to engage the venues and adult residents of highly deprived areas. Future studies recruiting adults living in the most deprived areas might benefit from community recruitment and from collaborating with local gatekeepers who are key to engagement. This study adheres to CONSORT guidelines.
TRIAL REGISTRATION
Retrospectively registered with ISRCTN ( http://www.isrctn.com/ISRCTN16872545 ) on 12.01.2018.",2020,The Awareness and Beliefs About Cancer (ABACus) phase 3 Randomised Control Trial recruited adult participants from socioeconomically deprived areas using a combined healthcare/community engagement model.,"['107 potential recruitment venues across South and West Yorkshire and South East Wales of which 41.1% (n\u2009=\u200942', 'Community and healthcare settings in areas of high socioeconomic deprivation were identified by lay advisors who recruited participants opportunistically or by appointment', 'A total of 234 participants were recruited, with 91% (n\u2009=\u2009212) retention at 2-weeks and 85% (n\u2009=\u2009199) at 6-months', 'participants from socioeconomically deprived communities: lessons from the Awareness and Beliefs About Cancer (ABACus3', 'adult participants from socioeconomically deprived areas using a combined healthcare/community engagement model', 'Participants had a mean age of 61.3\u2009years and 63.3% (n\u2009=\u2009148) were female, with 66% (n\u2009=\u2009154) resident in the most deprived geographical areas']",[],[],"[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0454879', 'cui_str': 'West Yorkshire'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]",[],[],234.0,0.218064,The Awareness and Beliefs About Cancer (ABACus) phase 3 Randomised Control Trial recruited adult participants from socioeconomically deprived areas using a combined healthcare/community engagement model.,"[{'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Kolovou', 'Affiliation': 'Centre for Trials Research Cardiff Metropolitan University, Cardiff, Wales, CF14 4YS, UK. vmkolovou@gmail.com.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Moriarty', 'Affiliation': 'Centre for Trials Research Cardiff Metropolitan University, Cardiff, Wales, CF14 4YS, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gilbert', 'Affiliation': 'Centre for Trials Research Cardiff Metropolitan University, Cardiff, Wales, CF14 4YS, UK.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Quinn-Scoggins', 'Affiliation': 'Division of Population Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Townson', 'Affiliation': 'Centre for Trials Research Cardiff Metropolitan University, Cardiff, Wales, CF14 4YS, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Padgett', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Sioned', 'Initials': 'S', 'LastName': 'Owen', 'Affiliation': 'Centre for Trials Research Cardiff Metropolitan University, Cardiff, Wales, CF14 4YS, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Buckle', 'Affiliation': 'Centre for Trials Research Cardiff Metropolitan University, Cardiff, Wales, CF14 4YS, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'Centre for Trials Research Cardiff Metropolitan University, Cardiff, Wales, CF14 4YS, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hepburn', 'Affiliation': 'Lead Lay Research Partner Wales Cancer Research Centre, Cardiff, Wales, UK.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Centre for Trials Research Cardiff Metropolitan University, Cardiff, Wales, CF14 4YS, UK.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Matthews', 'Affiliation': 'TENOVUS Cancer Care Gofal Canser, Cardiff, Wales, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Mitchell', 'Affiliation': 'Academic Unit of Primary Medical Care, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Neal', 'Affiliation': 'Leeds Institute for Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Playle', 'Affiliation': 'Centre for Trials Research Cardiff Metropolitan University, Cardiff, Wales, CF14 4YS, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research Cardiff Metropolitan University, Cardiff, Wales, CF14 4YS, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Smits', 'Affiliation': 'Division of Population Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Trubey', 'Affiliation': 'Centre for Trials Research Cardiff Metropolitan University, Cardiff, Wales, CF14 4YS, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Wood', 'Affiliation': 'Division of Population Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Brain', 'Affiliation': 'Division of Population Medicine, Cardiff University, Cardiff, UK.'}]",BMC medical research methodology,['10.1186/s12874-020-01149-x']
2092,33148211,Relationship between mothers' enjoyment and sedentary behavior and physical activity of mother-child dyads using a movement-to-music video program: a secondary analysis of a randomized controlled trial.,"BACKGROUND
Parental support and participation in physical activity (PA) with children and parents' acting as a role model for less sedentary behaviors (SB) are critical factors for children's healthier lifestyle. The purpose of the study was to assess the relationship between mothers' enjoyment and participants' sedentary behavior (SB) and physical activity (PA) as a secondary analysis of a randomized controlled trial (RCT) using data from Moving Sound RCT in the Pirkanmaa area of Finland.
METHODS
The participants were 108 mother-child dyads (child age 5-7 years) who completed the eight-week exercise intervention using a movement-to-music video program in their homes. Mothers' enjoyment was examined using a modified version of the enjoyment in sport questionnaire. The proportion of SB, standing, light PA, moderate-to-vigorous PA, and Total PA were derived from accelerometers at baseline and during the final week of the intervention. Analyses were performed using linear mixed-effect models for (1) intervention and control groups, (2) groups based on mothers' enjoyment.
RESULTS
The results highlighted that mothers' enjoyment of exercise with their children was overall high. Although there was no difference between the intervention and control groups, mothers in the intervention group increased their enjoyment during the intervention (p = 0.007). With mothers' higher enjoyment at baseline, children's light PA increased (p < 0.001), and with mothers' lower enjoyment, children's SB increased (p = 0.010). Further, if mothers' enjoyment decreased during the study, their own LPA increased (p = 0.049), and their children's SB increased (p = 0.013). If mothers' enjoyment remained stable, children's light PA (p = 0.002) and Total PA (p = 0.034) increased.
CONCLUSIONS
In this RCT, no differences were found between the intervention and control groups or groups based on mothers' enjoyment, possibly due to the low power of the study. However, mothers' enjoyment of exercise with their children increased within the intervention group, and mothers' enjoyment influenced children's SB and PA. For future studies, it would be essential to focus on children's enjoyment and factors behind the behavior change.
TRIAL REGISTRATION
The study is registered at ClinicalTrials.gov, registration number NTC02270138 , on October 2, 2014.",2020,"With mothers' higher enjoyment at baseline, children's light PA increased (p < 0.001), and with mothers' lower enjoyment, children's SB increased (p = 0.010).","[""mothers' enjoyment and participants' sedentary behavior (SB) and physical activity (PA"", 'participants were 108 mother-child dyads (child age 5-7\u2009years) who completed the eight-week']","['movement-to-music video program', 'exercise intervention using a movement-to-music video program']","[""children's SB"", ""children's light PA"", 'Total PA', 'proportion of SB, standing, light PA, moderate-to-vigorous PA, and Total PA']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.0541314,"With mothers' higher enjoyment at baseline, children's light PA increased (p < 0.001), and with mothers' lower enjoyment, children's SB increased (p = 0.010).","[{'ForeName': 'Pipsa P A', 'Initials': 'PPA', 'LastName': 'Tuominen', 'Affiliation': 'University of Jyväskylä, Faculty of Sport and Health Sciences, PO Box 35, FI-40014, Jyväskylä, Finland. pipsa.p.a.tuominen@jyu.fi.'}, {'ForeName': 'Jani', 'Initials': 'J', 'LastName': 'Raitanen', 'Affiliation': 'UKK Institute for Health Promotion Research, Tampere, Finland.'}, {'ForeName': 'Pauliina', 'Initials': 'P', 'LastName': 'Husu', 'Affiliation': 'UKK Institute for Health Promotion Research, Tampere, Finland.'}, {'ForeName': 'Riitta M', 'Initials': 'RM', 'LastName': 'Luoto', 'Affiliation': 'Tampere University, Faculty of Medicine and Biotechnology, Tampere, Finland.'}, {'ForeName': 'Urho M', 'Initials': 'UM', 'LastName': 'Kujala', 'Affiliation': 'University of Jyväskylä, Faculty of Sport and Health Sciences, PO Box 35, FI-40014, Jyväskylä, Finland.'}]",BMC public health,['10.1186/s12889-020-09773-4']
2093,33148311,Clinical decision support improves the appropriateness of laboratory test ordering in primary care without increasing diagnostic error: the ELMO cluster randomized trial.,"BACKGROUND
Inappropriate laboratory test ordering poses an important burden for healthcare. Clinical decision support systems (CDSS) have been cited as promising tools to improve laboratory test ordering behavior. The objectives of this study were to evaluate the effects of an intervention that integrated a clinical decision support service into a computerized physician order entry (CPOE) on the appropriateness and volume of laboratory test ordering, and on diagnostic error in primary care.
METHODS
This study was a pragmatic, cluster randomized, open-label, controlled clinical trial.
SETTING
Two hundred eighty general practitioners (GPs) from 72 primary care practices in Belgium.
PATIENTS
Patients aged ≥ 18 years with a laboratory test order for at least one of 17 indications: cardiovascular disease management, hypertension, check-up, chronic kidney disease (CKD), thyroid disease, type 2 diabetes mellitus, fatigue, anemia, liver disease, gout, suspicion of acute coronary syndrome (ACS), suspicion of lung embolism, rheumatoid arthritis, sexually transmitted infections (STI), acute diarrhea, chronic diarrhea, and follow-up of medication.
INTERVENTIONS
The CDSS was integrated into a computerized physician order entry (CPOE) in the form of evidence-based order sets that suggested appropriate tests based on the indication provided by the general physician.
MEASUREMENTS
The primary outcome of the ELMO study was the proportion of appropriate tests over the total number of ordered tests and inappropriately not-requested tests. Secondary outcomes of the ELMO study included diagnostic error, test volume, and cascade activities.
RESULTS
CDSS increased the proportion of appropriate tests by 0.21 (95% CI 0.16-0.26, p < 0.0001) for all tests included in the study. GPs in the CDSS arm ordered 7 (7.15 (95% CI 3.37-10.93, p = 0.0002)) tests fewer per panel. CDSS did not increase diagnostic error. The absolute difference in proportions was a decrease of 0.66% (95% CI 1.4% decrease-0.05% increase) in possible diagnostic error.
CONCLUSIONS
A CDSS in the form of order sets, integrated within the CPOE improved appropriateness and decreased volume of laboratory test ordering without increasing diagnostic error.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02950142 , registered on October 25, 2016.",2020,"GPs in the CDSS arm ordered 7 (7.15 (95% CI 3.37-10.93, p = 0.0002)) tests fewer per panel.","['Two hundred eighty general practitioners (GPs) from 72 primary care practices in Belgium', 'primary care without increasing diagnostic error', 'Patients aged ≥ 18\u2009years with a laboratory test order for at least one of 17 indications: cardiovascular disease management, hypertension, check-up, chronic kidney disease (CKD), thyroid disease, type 2 diabetes mellitus, fatigue, anemia, liver disease, gout, suspicion of acute coronary syndrome (ACS), suspicion of lung embolism, rheumatoid arthritis, sexually transmitted infections (STI), acute diarrhea, chronic diarrhea, and follow-up of medication']",['CDSS'],"['diagnostic error, test volume, and cascade activities', 'proportion of appropriate tests', 'proportion of appropriate tests over the total number of ordered tests and inappropriately not-requested tests', 'diagnostic error']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0011922', 'cui_str': 'Errors, Diagnostic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0420160', 'cui_str': 'History and physical examination, school'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0040128', 'cui_str': 'Disorder of thyroid gland'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C0401151', 'cui_str': 'Chronic diarrhea'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}]","[{'cui': 'C0011922', 'cui_str': 'Errors, Diagnostic'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",,0.153879,"GPs in the CDSS arm ordered 7 (7.15 (95% CI 3.37-10.93, p = 0.0002)) tests fewer per panel.","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Delvaux', 'Affiliation': 'Department of Public Health and Primary Care, KU Leuven, Kapucijnenvoer 33 Blok J PB 7001, B-3000, Leuven, Belgium. nicolas.delvaux@kuleuven.be.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Piessens', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Tine De', 'Initials': 'T', 'LastName': 'Burghgraeve', 'Affiliation': 'Department of Public Health and Primary Care, KU Leuven, Kapucijnenvoer 33 Blok J PB 7001, B-3000, Leuven, Belgium.'}, {'ForeName': 'Pavlos', 'Initials': 'P', 'LastName': 'Mamouris', 'Affiliation': 'Department of Public Health and Primary Care, KU Leuven, Kapucijnenvoer 33 Blok J PB 7001, B-3000, Leuven, Belgium.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Vaes', 'Affiliation': 'Department of Public Health and Primary Care, KU Leuven, Kapucijnenvoer 33 Blok J PB 7001, B-3000, Leuven, Belgium.'}, {'ForeName': 'Robert Vander', 'Initials': 'RV', 'LastName': 'Stichele', 'Affiliation': 'Department of Basic and Applied Medical Sciences, Ghent University, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Cloetens', 'Affiliation': 'Center for General Practice, University of Antwerp, Gouverneur Kinsbergen Centrum, Doornstraat 331, 2610, Wilrijk, Belgium.'}, {'ForeName': 'Josse', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'PharmaCS, Merchtem, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Public Health and Primary Care, KU Leuven, Kapucijnenvoer 33 Blok J PB 7001, B-3000, Leuven, Belgium.'}, {'ForeName': 'An De', 'Initials': 'A', 'LastName': 'Sutter', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Aertgeerts', 'Affiliation': 'Department of Public Health and Primary Care, KU Leuven, Kapucijnenvoer 33 Blok J PB 7001, B-3000, Leuven, Belgium.'}]",Implementation science : IS,['10.1186/s13012-020-01059-y']
2094,33148333,"Effectiveness of theta and gamma electroacupuncture for post-stroke patients on working memory and electrophysiology: study protocol for a double-center, randomized, patient- and assessor-blinded, sham-controlled, parallel, clinical trial.","BACKGROUND
Practitioners of complementary and alternative medicine have suggested that electroacupuncture (EA) could improve post-stroke cognitive impairment, based on the clinical evidence. This study protocol is aimed at showing the effectiveness of theta and gamma EA for post-stroke patients on working memory (WM) and electrophysiology.
METHODS
After assessing their eligibility, 66 patients with stroke will be enrolled from two Chinese medicine hospitals and randomly divided into theta frequency EA group, gamma frequency EA group, and sham-EA group according to the ratio of 1:1:1. All patients will receive 20 sessions of EA procedures for 4 weeks. Patients in three groups will receive EA at two same acupoints in the head: Baihui (GV20) and Shenting (GV24). The frequency of the three groups of EA is set as follows: 6 Hz (theta-EA group), 40 Hz (gamma-EA group), and no current through the electrodes (sham EA). Patients and assessors will be blinded throughout the entire study. The primary outcome is the performance accuracy of 1-back task which is a frequently used measure of WM in cognitive neuroscience research contexts. Secondary outcome measures will include the response time of 1-back task, the Rivermead Behavioral Memory Test, Trail Making Test, Loewenstein Occupational Therapy Cognitive Assessment Scale, modified Barthel Index, and electroencephalogram (EEG) signals during 1-back tasks. A blinding index will be assessed. Data will be statistically analyzed by one-way ANOVA, at 5% of significance level.
DISCUSSION
We expect this double-center, randomized, patient- and assessor-blinded, sham-controlled, parallel, clinical trial to explore the effectiveness of theta and gamma EA therapy, compared with sham EA, for post-stroke WM.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, ChiCTR2000031995 . Registered on 17 April 2020.",2020,Patients in three groups will receive EA at two same acupoints in the head: Baihui (GV20) and Shenting (GV24).,"['66 patients with stroke will be enrolled from two Chinese medicine hospitals and randomly divided into', 'post-stroke patients on working memory and electrophysiology', 'post-stroke patients on working memory (WM) and electrophysiology']","['theta and gamma EA therapy', 'theta and gamma EA', 'theta frequency EA group, gamma frequency EA group, and sham-EA', 'EA at two same acupoints in the head: Baihui (GV20) and Shenting (GV24', 'electroacupuncture (EA', 'theta and gamma electroacupuncture']","['performance accuracy of 1-back task which is a frequently used measure of WM in cognitive neuroscience research contexts', 'response time of 1-back task, the Rivermead Behavioral Memory Test, Trail Making Test, Loewenstein Occupational Therapy Cognitive Assessment Scale, modified Barthel Index, and electroencephalogram (EEG) signals during 1-back tasks']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0013865', 'cui_str': 'Electrophysiology'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0450804', 'cui_str': 'GV24'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C4042951', 'cui_str': 'Cognitive Neuroscience'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0475507', 'cui_str': 'Rivermead behavioral memory test'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0451269', 'cui_str': 'Loewenstein Occupational Therapy Cognitive Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",66.0,0.294426,Patients in three groups will receive EA at two same acupoints in the head: Baihui (GV20) and Shenting (GV24).,"[{'ForeName': 'Jing-Jing', 'Initials': 'JJ', 'LastName': 'Xu', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, 110 Ganhe Road, Hongkou District, Shanghai, 200000, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Ren', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Pudong New District, Shanghai, 200000, China.'}, {'ForeName': 'Jing-Jun', 'Initials': 'JJ', 'LastName': 'Zhao', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Pudong New District, Shanghai, 200000, China.'}, {'ForeName': 'Jia-Jia', 'Initials': 'JJ', 'LastName': 'Wu', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, 110 Ganhe Road, Hongkou District, Shanghai, 200000, China.'}, {'ForeName': 'Si-Cong', 'Initials': 'SC', 'LastName': 'Zhang', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, 110 Ganhe Road, Hongkou District, Shanghai, 200000, China.'}, {'ForeName': 'Yan-Biao', 'Initials': 'YB', 'LastName': 'Zhong', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Pudong New District, Shanghai, 200000, China.'}, {'ForeName': 'Shu-Tian', 'Initials': 'ST', 'LastName': 'Xu', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Pudong New District, Shanghai, 200000, China.'}, {'ForeName': 'Zhong-Yao', 'Initials': 'ZY', 'LastName': 'Cao', 'Affiliation': 'Anhui Wannan Rehabilitation Hospital, 3 Zheshang road, Jinghu District, Wuhu City, 241000, Anhui Province, China.'}, {'ForeName': 'Zhi-Qing', 'Initials': 'ZQ', 'LastName': 'Zhou', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Pudong New District, Shanghai, 200000, China.'}, {'ForeName': 'Yuan-Li', 'Initials': 'YL', 'LastName': 'Li', 'Affiliation': 'Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Pudong New District, Shanghai, 200000, China. liyuan218@126.com.'}, {'ForeName': 'Chun-Lei', 'Initials': 'CL', 'LastName': 'Shan', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, 110 Ganhe Road, Hongkou District, Shanghai, 200000, China. shanclhappy@163.com.'}]",Trials,['10.1186/s13063-020-04807-z']
2095,33148343,"Process evaluation of an implementation trial to improve the triage, treatment and transfer of stroke patients in emergency departments (T 3 trial): a qualitative study.","BACKGROUND
The implementation of evidence-based protocols for stroke management in the emergency department (ED) for the appropriate triage, administration of tissue plasminogen activator to eligible patients, management of fever, hyperglycaemia and swallowing, and prompt transfer to a stroke unit were evaluated in an Australian cluster-randomised trial (T 3 trial) conducted at 26 emergency departments. There was no reduction in 90-day death or dependency nor improved processes of ED care. We conducted an a priori planned process influential factors that impacted upon protocol uptake.
METHODS
Qualitative face-to-face interviews were conducted with purposively selected ED and stroke clinicians from two high- and two low-performing intervention sites about their views on factors that influenced protocol uptake. All Trial State Co-ordinators (n = 3) who supported the implementation at the 13 intervention sites were also interviewed. Data were analysed thematically using normalisation process theory as a sensitising framework to understand key findings, and compared and contrasted between interviewee groups.
RESULTS
Twenty-five ED and stroke clinicians, and three Trial State Co-ordinators were interviewed. Three major themes represented key influences on evidence uptake: (i) Readiness to change: reflected strategies to mobilise and engage clinical teams to foster cognitive participation and collective action; (ii) Fidelity to the protocols: reflected that beliefs about the evidence underpinning the protocols impeded the development of a shared understanding about the applicability of the protocols in the ED context (coherence); and (iii) Boundaries of care: reflected that appraisal (reflexive monitoring) by ED and stroke teams about their respective boundaries of clinical practice impeded uptake of the protocols.
CONCLUSIONS
Despite initial high 'buy-in' from clinicians, a theoretically informed and comprehensive implementation strategy was unable to overcome system and clinician level barriers. Initiatives to drive change and integrate protocols rested largely with senior nurses who had to overcome contextual factors that fell outside their control, including low medical engagement, beliefs about the supporting evidence and perceptions of professional boundaries. To maximise uptake of evidence and adherence to intervention fidelity in complex clinical settings such as ED cost-effective strategies are needed to overcome these barriers.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry ( ACTRN12614000939695 ).",2020,There was no reduction in 90-day death or dependency nor improved processes of ED care.,"['stroke patients in emergency departments (T 3 trial', 'Qualitative face-to-face interviews were conducted with purposively selected ED and stroke clinicians from two high- and two low-performing intervention sites about their views on factors that influenced protocol uptake']",[],['90-day death or dependency nor improved processes of ED care'],"[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]",,0.0429325,There was no reduction in 90-day death or dependency nor improved processes of ED care.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McInnes', 'Affiliation': ""Nursing Research Institute - St Vincent's Health Network Sydney, St Vincent's Hospital Melbourne & Australian Catholic University, School of Nursing, Midwifery & Paramedicine, Australian Catholic University, Level 4, Daniel Mannix Building, Brunswick Street, Fitzroy, Victoria, 3065, Australia. liz.mcinnes@acu.edu.au.""}, {'ForeName': 'Simeon', 'Initials': 'S', 'LastName': 'Dale', 'Affiliation': ""Nursing Research Institute - St Vincent's Health Network Sydney, St Vincent's Hospital Melbourne & Australian Catholic University, Level 5, deLacy Building, Victoria Street, Darlinghurst, New South Wales, 2010, Australia.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Craig', 'Affiliation': ""Nursing Research Institute - St Vincent's Health Network Sydney, St Vincent's Hospital Melbourne & Australian Catholic University, Level 5, deLacy Building, Victoria Street, Darlinghurst, New South Wales, 2010, Australia.""}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': ""Nursing Research Institute - St Vincent's Health Network Sydney, St Vincent's Hospital Melbourne & Australian Catholic University, Level 5, deLacy Building, Victoria Street, Darlinghurst, New South Wales, 2010, Australia.""}, {'ForeName': 'Oyebola', 'Initials': 'O', 'LastName': 'Fasugba', 'Affiliation': ""Nursing Research Institute - St Vincent's Health Network Sydney, St Vincent's Hospital Melbourne & Australian Catholic University, Level 2, Signadou Building, Australian Catholic University, 223 Antill Street, Watson, Australian Capital Territory, 2602, Australia.""}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Schadewaldt', 'Affiliation': 'Department of Neurosurgery, University of Melbourne and Royal Melbourne Hospital, Grattan Street, Parkville, Victoria, 3050, Australia.'}, {'ForeName': 'N Wah', 'Initials': 'NW', 'LastName': 'Cheung', 'Affiliation': 'Centre for Diabetes and Endocrinology Research, Westmead Hospital and University of Sydney, Westmead, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dominique A', 'Initials': 'DA', 'LastName': 'Cadilhac', 'Affiliation': 'Stroke and Ageing Research, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Health Research Institute, Ottawa Hospital - General Campus, Centre for Practice-Changing Research (CPCR), 501 Smyth Road, Room 1286, Ottawa, Ontario, K1H 8\u2009L6, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Levi', 'Affiliation': 'The Sydney Partnership for Health Education Research & Enterprise (SPHERE), University of New South Wales, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Considine', 'Affiliation': 'School of Nursing and Midwifery, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McElduff', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gerraty', 'Affiliation': 'Department of Medicine, Monash University, Melbourne, Victoria, 3800, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Surgery, Central Clinical School, Monash University, Melbourne, Victoria, 3800, Australia.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Ward', 'Affiliation': 'Nulungu Research Institute, University of Notre Dame Australia, Broome, Western Australia, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': ""D'Este"", 'Affiliation': 'National Centre for Epidemiology and Population Health (NCEPH), Australian National University, Canberra, Australian Capital Territory, 0200, Australia.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': ""Nursing Research Institute - St Vincent's Health Network Sydney, St Vincent's Hospital Melbourne & Australian Catholic University, Level 5, deLacy Building, Victoria Street, Darlinghurst, New South Wales, 2010, Australia.""}]",Implementation science : IS,['10.1186/s13012-020-01057-0']
2096,33148357,Current measures of distress may not account for what's most important in existential care interventions: Results of the outlook trial.,"OBJECTIVE
Compare the efficacy of two interventions addressing emotional and existential well-being in early life-limiting illness.
METHOD
Primary trial analysis (n = 135) included patients with advanced cancer, congestive heart failure, or end-stage renal disease; Arm 1 received the Outlook intervention, addressing issues of life completion and preparation, and Arm 2 received relaxation meditation (RM). Primary outcomes at five weeks (primary endpoint) and seven weeks (secondary): completion and preparation (QUAL-E); secondary outcomes: anxiety (POMS) quality of life (FACT-G) and spiritual well-being (FACIT-Sp) subscales of faith, meaning, and peace.
RESULTS
Average age was 62; 56% were post-high school-educated, 54% were married, 52% white, 44% female, and 70% had a cancer diagnosis. At baseline, participants demonstrated low levels of anxiety (<5 on POMS subscale) and depression (<10 on CESD) relative to population norms. Results of the primary analysis revealed no significant differences in mean Preparation by treatment arm at five weeks (14.4 Outlook vs. 14.8 RM; between-group difference -0.4 [95% CI, -1.6, 0.8], p = 0.49) or seven weeks (15.2 vs.15.4; between-group difference -0.2 [95% CI, -1.5, 1.0], p = 0.73). There were also no significant differences in mean Life Completion by treatment arm between five weeks (26.6 Outlook vs. 26.3 RM; between-group difference 0.2 [95% CI, -1.2, 1.7], p = 0.76) or seven weeks (26.5 vs. 27.5; between-group difference -1.0 [95% CI, -2.7, 0.7], p = 0.23). Compared to RM, Outlook participants did not have significant differences over time in the secondary outcomes of overall quality of life, anxiety, depression, FACT-G subscales, and FACIT-Sp subscales.
DISCUSSION
In early-stage life-limiting illness, Outlook did not demonstrate a significant difference in primary or secondary outcomes relative to RM. Results underscore the importance of pre-screening for distress. Qualitatively, Outlook participants were able to express suppressed emotions, place illness context, reflect on adaptations, and strengthen identity. Screening for distress and identifying specified measures of distress, beyond anxiety and depression, is essential in our ability to adequately assess the multi-dimensional mechanisms that decrease existential suffering.",2020,"Compared to RM, Outlook participants did not have significant differences over time in the secondary outcomes of overall quality of life, anxiety, depression, FACT-G subscales, and FACIT-Sp subscales.
","['Primary trial analysis (n = 135) included patients with advanced cancer, congestive heart failure, or end-stage renal disease; Arm 1 received the', 'Average age was 62; 56% were post-high school-educated, 54% were married, 52% white, 44% female, and 70% had a cancer diagnosis']","['Outlook intervention, addressing issues of life completion and preparation, and Arm 2 received relaxation meditation (RM']","['mean Preparation', 'seven weeks (secondary): completion and preparation (QUAL-E); secondary outcomes: anxiety (POMS) quality of life (FACT-G) and spiritual well-being (FACIT-Sp) subscales of faith, meaning, and peace', 'low levels of anxiety', 'mean Life Completion', 'overall quality of life, anxiety, depression, FACT-G subscales, and FACIT-Sp subscales', 'emotions, place illness context, reflect on adaptations, and strengthen identity']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0555047', 'cui_str': 'Married'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}]",135.0,0.259508,"Compared to RM, Outlook participants did not have significant differences over time in the secondary outcomes of overall quality of life, anxiety, depression, FACT-G subscales, and FACIT-Sp subscales.
","[{'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Steinhauser', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham, VA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Stechuchak', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham, VA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Ramos', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham, VA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Winger', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Tulsky', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham, VA.'}]",Palliative & supportive care,['10.1017/S1478951520001170']
2097,33148502,Respiratory sinus arrhythmia biofeedback alters heart rate variability and default mode network connectivity in major depressive disorder: A preliminary study.,"Traditional major depressive disorder (MDD) interventions do not improve heart rate variability (HRV), despite symptom reduction. We investigated whether respiratory sinus arrhythmia (RSA)-biofeedback (BFB) effectively changed HRV, psychological symptoms, and functional connectivity of the default mode network (DMN), which is known to increase in MDD. Thirty MDD patients were randomly assigned to two groups (RSA-BFB with treatment as usual [TAU] with medication [BFB + TAU; n = 16] and TAU [n = 14]). Six RSA-BFB sessions were performed over 4 weeks. We assessed psychological symptoms (including depression, anxiety, and hopelessness), high frequency (HF; an index of HRV during rest and stress), and DMN functional connectivity, as measured by source-level coherence of 19-channel electroencephalography using standardized weighted low-resolution brain electromagnetic tomography. Large-scale DMN was represented by small-worldness based on graph theory. The BFB + TAU group showed greater reductions in depression (especially psychic anxiety and vegetative symptoms) compared to the TAU group. Significant group by session interactions were found in resting HF-HRV, stress-reactive HF-HRV, and beta DMN small-worldness. During the post-intervention session, the BFB + TAU group showed higher resting HF-HRV and stress-reactive HF-HRV (d = 1.41 for the resting stage and d = 1.99 for the Stroop test, P < .005). Compared to baseline, the BFB + TAU group showed increased HF-HRV reactivity and decreased DMN small-worldness in the beta band, implying decreased global DMN functional connectivity. Conversely, the TAU group showed decreased HF-HRV during stress and no DMN alterations. This study was limited by small sample size and open-label design. These preliminary findings suggest that brief RSA-BFB may improve autonomic nervous system and DMN functions in MDD.",2020,The BFB + TAU group showed greater reductions in depression (especially psychic anxiety and vegetative symptoms) compared to the TAU group.,"['Thirty MDD patients', 'major depressive disorder']","['RSA-BFB', 'RSA-BFB with treatment as usual [TAU] with medication [BFB\xa0+\xa0TAU; n\xa0=\xa016] and TAU', 'TAU', 'respiratory sinus arrhythmia (RSA)-biofeedback (BFB']","['HF-HRV reactivity', 'resting HF-HRV, stress-reactive HF-HRV, and beta DMN small-worldness', 'heart rate variability (HRV', 'psychological symptoms (including depression, anxiety, and hopelessness), high frequency (HF; an index of HRV during rest and stress), and DMN functional connectivity, as measured by source-level coherence of 19-channel electroencephalography', 'global DMN functional connectivity', 'HF-HRV', 'resting HF-HRV and stress-reactive HF-HRV', 'depression (especially psychic anxiety and vegetative symptoms']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",30.0,0.0595873,The BFB + TAU group showed greater reductions in depression (especially psychic anxiety and vegetative symptoms) compared to the TAU group.,"[{'ForeName': 'Su Mi', 'Initials': 'SM', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea; Department of Clinical Medical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Yeon', 'Initials': 'HY', 'LastName': 'Jung', 'Affiliation': 'Department of Psychiatry, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea; Department of Clinical Medical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Psychiatry and Behavioral Science and Institute of Human Behavioral Medicine, National University College of Medicine, Seoul, Republic of Korea. Electronic address: hyjung@snu.ac.kr.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.10.008']
2098,33148538,"Use of multiple period, cluster randomised, crossover trial designs for comparative effectiveness research.",,2020,,[],[],[],[],[],[],,0.0304652,,"[{'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham B15 2TT, UK k.hemming@bham.ac.uk.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Weijer', 'Affiliation': 'Departments of Medicine, Epidemiology, and Biostatistics, and Philosophy, Western University, London, ON, Canada.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Forbes', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m3800']
2099,33148541,"Subsidise the test, the treatment or both? Results of an individually randomised controlled trial of the management of suspected malaria fevers in the retail sector in western Kenya.","INTRODUCTION
In many malaria-endemic countries, the private retail sector is a major source of antimalarial drugs. However, the rarity of malaria diagnostic testing in the retail sector leads to overuse of the first-line class of antimalarial drugs known as artemisinin-combination therapies (ACTs). The goal of this study was to identify the combination of malaria rapid diagnostic test (RDT) and ACT subsidies that maximises the proportion of clients seeking care in a retail outlet that choose to purchase an RDT (RDT uptake) and use ACTs appropriately.
METHODS
842 clients seeking care in 12 select retail outlets in western Kenya were recruited and randomised into 4 arms of different combinations of ACT and RDT subsidies, with ACT subsidies conditional on a positive RDT. The outcomes were RDT uptake (primary) and appropriate and targeted ACT use (secondary). Participants' familiarity with RDTs and their confidence in test results were also evaluated.
RESULTS
RDT uptake was high (over 96%) across the study arms. Testing uptake was 1.025 times higher (98% CI 1.002 to 1.049) in the RDT subsidised arms than in the unsubsidised groups. Over 98% of clients were aware of malaria testing, but only 35% had a previous experience with RDTs. Nonetheless, confidence in the accuracy of RDTs was high. We found high levels of appropriate use and targeting of ACTs, with 86% of RDT positives taking an ACT, and 93.4% of RDT negatives not taking an ACT. The conditional ACT subsidy did not affect the RDT test purchasing behaviour (risk ratio: 0.994; 98% CI 0.979 to 1.009).
CONCLUSION
Test dependent ACT subsidies may contribute to ACT targeting. However, in this context, high confidence in the accuracy of RDTs and reliable supplies of RDTs and ACTs likely played a greater role in testing uptake and adherence to test results.",2020,Testing uptake was 1.025 times higher (98% CI 1.002 to 1.049) in the RDT subsidised arms than in the unsubsidised groups.,"['842 clients seeking care in 12 select retail outlets in western Kenya', 'suspected malaria fevers in the retail sector in western Kenya']","['ACT and RDT subsidies, with ACT subsidies conditional on a positive RDT']","['Testing uptake', 'RDT uptake', 'RDT test purchasing behaviour', 'RDT uptake (primary) and appropriate and targeted ACT use (secondary']","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]","[{'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",842.0,0.0582996,Testing uptake was 1.025 times higher (98% CI 1.002 to 1.049) in the RDT subsidised arms than in the unsubsidised groups.,"[{'ForeName': 'Jeremiah', 'Initials': 'J', 'LastName': 'Laktabai', 'Affiliation': 'Department of Family Medicine, Moi University School of Medicine, Eldoret, Kenya jklaktabai@gmail.com.'}, {'ForeName': 'Indrani', 'Initials': 'I', 'LastName': 'Saran', 'Affiliation': 'Boston College School of Social Work, Chestnut Hill, Massachusetts, USA.'}, {'ForeName': 'Yunji', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Simmons', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Theodoor', 'Initials': 'T', 'LastName': 'Visser', 'Affiliation': 'Clinton Health Access Initiative, Boston, Massachusetts, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': ""O'Meara"", 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, North Carolina, USA.'}]",BMJ global health,['10.1136/bmjgh-2020-003378']
2100,33148601,Effect of monitoring surgical outcomes using control charts to reduce major adverse events in patients: cluster randomised trial.,"OBJECTIVE
To determine the effect of introducing prospective monitoring of outcomes using control charts and regular feedback on indicators to surgical teams on major adverse events in patients.
DESIGN
National, parallel, cluster randomised trial embedding a difference-in-differences analysis.
SETTING
40 surgical departments of hospitals across France.
PARTICIPANTS
155 362 adults who underwent digestive tract surgery. 20 of the surgical departments were randomised to prospective monitoring of outcomes using control charts with regular feedback on indicators (intervention group) and 20 to usual care only (control group).
INTERVENTIONS
Prospective monitoring of outcomes using control charts, provided in sets quarterly, with regular feedback on indicators (intervention hospitals). To facilitate implementation of the programme, study champion partnerships were established at each site, comprising a surgeon and another member of the surgical team (surgeon, anaesthetist, or nurse), and were trained to conduct team meetings, display posters in operating rooms, maintain a logbook, and devise an improvement plan.
MAIN OUTCOME MEASURES
The primary outcome was a composite of major adverse events (inpatient death, intensive care stay, reoperation, and severe complications) within 30 days after surgery. Changes in surgical outcomes were compared before and after implementation of the programme between intervention and control hospitals, with adjustment for patient mix and clustering.
RESULTS
75 047 patients were analysed in the intervention hospitals (37 579 before and 37 468 after programme implementation) versus 80 315 in the control hospitals (41 548 and 38 767). After introduction of the control chart, the absolute risk of a major adverse event was reduced by 0.9% (95% confidence interval 0.4% to 1.4%) in intervention compared with control hospitals, corresponding to 114 patients (70 to 280) who needed to receive the intervention to prevent one major adverse event. A significant decrease in major adverse events (adjusted ratio of odds ratios 0.89, 95% confidence interval 0.83 to 0.96), patient death (0.84, 0.71 to 0.99), and intensive care stay (0.85, 0.76 to 0.94) was found in intervention compared with control hospitals. The same trend was observed for reoperation (0.91, 0.82 to 1.00), whereas severe complications remained unchanged (0.96, 0.87 to 1.07). Among the intervention hospitals, the effect size was proportional to the degree of control chart implementation witnessed. Highly compliant hospitals experienced a more important reduction in major adverse events (0.84, 0.77 to 0.92), patient death (0.78, 0.63 to 0.97), intensive care stay (0.76, 0.67 to 0.87), and reoperation (0.84, 0.74 to 0.96).
CONCLUSIONS
The implementation of control charts with feedback on indicators to surgical teams was associated with concomitant reductions in major adverse events in patients. Understanding variations in surgical outcomes and how to provide safe surgery is imperative for improvements.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02569450.",2020,The implementation of control charts with feedback on indicators to surgical teams was associated with concomitant reductions in major adverse events in patients.,"['40 surgical departments of hospitals across France', '20 of the surgical departments', '75\u2009047 patients were analysed in the intervention hospitals (37\u2009579 before and 37\u2009468 after programme implementation) versus 80\u2009315 in the control hospitals (41\u2009548 and 38\u2009767', '155\u2009362 adults who underwent digestive tract surgery', 'patients']",['control charts with regular feedback on indicators (intervention group) and 20 to usual care only (control group'],"['absolute risk of a major adverse event', 'patient death', 'composite of major adverse events (inpatient death, intensive care stay, reoperation, and severe complications', 'intensive care stay', 'major adverse events', 'reoperation', 'severe complications']","[{'cui': 'C0587503', 'cui_str': 'Surgical department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",155362.0,0.146198,The implementation of control charts with feedback on indicators to surgical teams was associated with concomitant reductions in major adverse events in patients.,"[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Duclos', 'Affiliation': 'Health Services and Performance Research lab (HeSPeR, EA 7425), Université Claude Bernard Lyon 1, France antoineduclos@yahoo.fr.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Chollet', 'Affiliation': 'Health Data Department, Hospices Civils de Lyon, France.'}, {'ForeName': 'Léa', 'Initials': 'L', 'LastName': 'Pascal', 'Affiliation': 'Health Data Department, Hospices Civils de Lyon, France.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Ormando', 'Affiliation': 'Human Resource Department, EM Lyon Business School, France.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carty', 'Affiliation': ""Center for Surgery and Public Health, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Polazzi', 'Affiliation': 'Health Services and Performance Research lab (HeSPeR, EA 7425), Université Claude Bernard Lyon 1, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Lifante', 'Affiliation': 'Health Services and Performance Research lab (HeSPeR, EA 7425), Université Claude Bernard Lyon 1, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.m3840']
2101,33148620,FOLFOXIRI plus bevacizumab versus FOLFOX plus bevacizumab for patients with metastatic colorectal cancer and ≥3 circulating tumour cells: the randomised phase III VISNÚ-1 trial.,"PURPOSE
5-Fluorouracil/leucovorin, oxaliplatin, irinotecan (FOLFOXIRI) plus bevacizumab is more effective than doublets plus bevacizumab as first-line therapy for metastatic colorectal cancer, but is not widely used because of concerns about toxicity and lack of predictive biomarkers. This study was designed to explore the role of circulating tumour cell (CTC) count as a biomarker to select patients for therapy with FOLFOXIRI-bevacizumab.
PATIENTS AND METHODS
VISNÚ-1 was a multicentre, open-label, randomised, phase III study in patients with previously untreated, unresectable, metastatic colorectal carcinoma and ≥3 CTC/7.5 mL blood. Patients received bevacizumab 5 mg/kg plus FOLFOXIRI (irinotecan 165 mg/m 2 , oxaliplatin 85 mg/m 2 , leucovorin 400 mg/m 2 and 5-fluorouracil 3200 mg/m 2 ) or FOLFOX (oxaliplatin 85 mg/m 2 , leucovorin 400 mg/m 2 , 5-fluorouracil 400 mg/m 2 then 2400 mg/m 2 ) by intravenous administration every 2 weeks. The primary outcome was progression-free survival (PFS).
RESULTS
The intention-to-treat population comprised 349 patients (FOLFOXIRI-bevacizumab, n=172; FOLFOX-bevacizumab, n=177). Median PFS was 12.4 months (95% CI 11.2 to 14.0) with FOLFOXIRI bevacizumab and 9.3 months (95% CI 8.5 to 10.7) with FOLFOX-bevacizumab (stratified HR, 0.64; 95% CI 0.49 to 0.82; p=0.0006). Grade≥3 adverse events were more common with FOLFOXIRI-bevacizumab 85.3% vs 75.1% with FOLFOX-bevacizumab (p=0.0178). Treatment-related deaths occurred in 8 (4.7%) and 6 (3.4%) patients, respectively.
CONCLUSIONS
First-line FOLFOXIRI-bevacizumab significantly improved PFS compared with FOLFOX-bevacizumab in patients with metastatic colorectal cancer and ≥3 CTCs at baseline, which indicate a poor prognosis. CTC count may be a useful non-invasive biomarker to assist with the selection of patients for intensive first-line therapy.",2020,Grade≥3 adverse events were more common with FOLFOXIRI-bevacizumab 85.3% vs 75.1% with FOLFOX-bevacizumab (p=0.0178).,"['patients with metastatic colorectal cancer', 'metastatic colorectal cancer', 'patients with previously untreated, unresectable, metastatic colorectal carcinoma and ≥3 CTC/7.5\u2009mL blood', 'patients with metastatic colorectal cancer and ≥3 circulating tumour cells']","['FOLFOXIRI-bevacizumab', 'FOLFOX plus bevacizumab', 'First-line FOLFOXIRI-bevacizumab', 'bevacizumab', 'bevacizumab 5 mg/kg plus FOLFOXIRI (irinotecan 165 mg/m 2 , oxaliplatin 85 mg/m 2 , leucovorin 400 mg/m 2 and 5-fluorouracil 3200 mg/m 2 ) or FOLFOX (oxaliplatin 85 mg/m 2 , leucovorin 400 mg/m 2 , 5-fluorouracil 400', 'FOLFOX-bevacizumab', 'FOLFOXIRI plus bevacizumab', 'FOLFOXIRI bevacizumab', '5-Fluorouracil/leucovorin, oxaliplatin, irinotecan (FOLFOXIRI) plus bevacizumab']","['Median PFS', 'circulating tumour cell (CTC) count', 'deaths', 'Grade≥3 adverse events', 'PFS', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0934954,Grade≥3 adverse events were more common with FOLFOXIRI-bevacizumab 85.3% vs 75.1% with FOLFOX-bevacizumab (p=0.0178).,"[{'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Aranda', 'Affiliation': 'IMIBIC, University of Cordoba, CIBERONC, Instituto de Salud Carlos III, Hospital Universitario Reina Sofía, Medical Oncology Department, Cordoba, Spain earandaa@seom.org.'}, {'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'Viéitez', 'Affiliation': 'Hospital Universitario Central de Asturias, Medical Oncology Department, Oviedo, Spain.'}, {'ForeName': 'Auxiliadora', 'Initials': 'A', 'LastName': 'Gómez-España', 'Affiliation': 'IMIBIC, University of Cordoba, CIBERONC, Instituto de Salud Carlos III, Hospital Universitario Reina Sofía, Medical Oncology Department, Cordoba, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gil Calle', 'Affiliation': 'Hospital Universitario Regional y Virgen de la Victoria, Medical Oncology Department, Málaga, Spain.'}, {'ForeName': 'Antonieta', 'Initials': 'A', 'LastName': 'Salud-Salvia', 'Affiliation': 'Hospital Universitario Arnau de Vilanova de Lleida, Medical Oncology Department, Lleida, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Graña', 'Affiliation': 'University Hospital A Coruña, SERGAS, Medical Oncology Department, La Coruña, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Garcia-Alfonso', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Medical Oncology Department, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': 'Hospital Universitario Marqués de Valdecilla, IDIVAL, Medical Oncology Department, Santander, Spain.'}, {'ForeName': 'Guillermo Alfonso', 'Initials': 'GA', 'LastName': 'Quintero-Aldana', 'Affiliation': 'Hospital Universitario Lucus Augusti, Medical Oncology Department, Lugo, Spain.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Reina-Zoilo', 'Affiliation': 'Complejo Universitario Virgen de la Macarena, Medical Oncology Department, Seville, Spain.'}, {'ForeName': 'Encarnación', 'Initials': 'E', 'LastName': 'González-Flores', 'Affiliation': 'Hospital Universitario Virgen de las Nieves, Medical Oncology Department, Granada, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Salgado Fernández', 'Affiliation': 'Complexo Hospitalario Universitario de Ourense, Medical Oncology Department, Ourense, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Guillén-Ponce', 'Affiliation': 'Hospital Universitario Ramón y Cajal, Medical Oncology Department, Madrid, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Garcia-Carbonero', 'Affiliation': 'Hospital Universitario 12 de Octubre, imas12, UCM, CIBERONC, Medical Oncology Department, Madrid, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Safont', 'Affiliation': 'Hospital General Universitario de Valencia, Medical Oncology Department, Valencia, Spain.'}, {'ForeName': 'Adelaida', 'Initials': 'A', 'LastName': 'La Casta Munoa', 'Affiliation': 'Hospital Universitario de Donostia, Medical Oncology Department, San Sebastian, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'García-Paredes', 'Affiliation': 'Instituto de Investigación Hospital Clinico San Carlos (IdISSC), CIBERONC, Hospital Clínico San Carlos, Medical Oncology Department, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'López López', 'Affiliation': 'University Hospital and Health Research Institute (IDIS), CIBERONC, Santiago de Compostela University School of Medicine, Medical Oncology Department, Santiago de Compostela, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sastre', 'Affiliation': 'Instituto de Investigación Hospital Clinico San Carlos (IdISSC), CIBERONC, Hospital Clínico San Carlos, Medical Oncology Department, Madrid, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Díaz-Rubio', 'Affiliation': 'Instituto de Investigación Hospital Clinico San Carlos (IdISSC), CIBERONC, Hospital Clínico San Carlos, Medical Oncology Department, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",ESMO open,['10.1136/esmoopen-2020-000944']
2102,33152781,[Online Rehab-Need Test (OREST): Effectiveness of an Invitation to Proactive Screening (self-test) for the Need for Medical Rehabilitation Among Individuals Covered by the German Statutory Pension Insurance Agencies in Baden-Württemberg and the Rhine Region].,"PURPOSE
Up to now, there has been a lack of proactive approaches on the part of the rehabilitation providers, while simultaneously a suspected unmet rehabilitation need exists in some groups of insured persons. Therefore, the effectiveness of the invitation to a web-based self-test for rehabilitation needs as a new access route to medical rehabilitation was evaluated. The main question was whether the intervention leads to more approved rehabilitation applications in the follow-up period of 22 months and whether this effect is also apparent after controlling other influencing variables.
METHODS
A randomized, controlled study with N=8000 insured persons of two regional statutory pension insurance agencies was conducted to check the effectiveness of the intervention. Insured persons of the intervention group (IG; n=4000) were informed by mail about the web-based self-test and received individual access data for it (user ID and PIN). The control group (CG; n=4000) received no information about the self-test. The primary outcome was the rate of approved rehabilitation applications, the secondary outcome was the application rate regardless of approval.
RESULTS
Groups do not differ significantly in terms of primary or secondary outcomes. Even after controlling for other influencing factors, the intervention does not contribute to the prediction of outcomes, but some control variables, such as previous rehabilitation experience, prove to be important predictors for the application.
CONCLUSION
The mere offer of a self-test for rehabilitation need by the pension insurance institution has no effect on the application process. Hence a letter from the pension insurance institution as the sole means of access does not appear suitable for increasing the rate of meaningful rehabilitation applications.",2020,The mere offer of a self-test for rehabilitation need by the pension insurance institution has no effect on the application process.,"['N=8000 insured persons of two regional statutory pension insurance agencies', 'Individuals Covered by the German Statutory Pension Insurance Agencies in Baden-Württemberg and the Rhine Region']","['Invitation to Proactive Screening (self-test', 'Online Rehab-Need Test (OREST']","['rate of approved rehabilitation applications', 'application rate regardless of approval']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0030854', 'cui_str': 'Retirement Benefits'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]","[{'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0185125', 'cui_str': 'Application'}]",8000.0,0.0232668,The mere offer of a self-test for rehabilitation need by the pension insurance institution has no effect on the application process.,"[{'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Schlöffel', 'Affiliation': 'Sektion Versorgungsforschung und Rehabilitationsforschung, Universitätsklinikum Freiburg, Medizinische Fakultät der Universität Freiburg.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Kampling', 'Affiliation': 'Sektion Versorgungsforschung und Rehabilitationsforschung, Universitätsklinikum Freiburg, Medizinische Fakultät der Universität Freiburg.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Fichtner', 'Affiliation': 'Sektion Versorgungsforschung und Rehabilitationsforschung, Universitätsklinikum Freiburg, Medizinische Fakultät der Universität Freiburg.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Farin-Glattacker', 'Affiliation': 'Sektion Versorgungsforschung und Rehabilitationsforschung, Universitätsklinikum Freiburg, Medizinische Fakultät der Universität Freiburg.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Pollmann', 'Affiliation': 'Klinik Niederrhein der Deutschen Rentenversicherung Rheinland, Bad Neuenahr-Ahrweiler.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Mittag', 'Affiliation': 'Sektion Versorgungsforschung und Rehabilitationsforschung, Universitätsklinikum Freiburg, Medizinische Fakultät der Universität Freiburg.'}]",Die Rehabilitation,['10.1055/a-1282-8564']
2103,33152791,[The Maastricht Education System in Aachen - a Few Miles Away or Worlds Apart?],"INTRODUCTION
Education for residents in surgery varies not only throughout the world, but also throughout Europe. Our clinic is well connected to Maastricht University Medical in Centre in the Netherlands (European Surgical Centre Aachen Maastricht). On the other hand, there are clear differences in resident programs. In the Netherlands, a structured feedback according to the OSATS concept (Objective Structured Assessment of Technical Skills) is mandatory after every operation performed by residents. The aim of the present study was to transfer the OSATS concept from Maastricht to Aachen and to evaluate the feasibility and benefits of this concept for surgical education.
MATERIAL AND METHODS
The OSATS concept was implemented for 3 months in our clinic within a prospective clinical trial. Seven out of 10 residents that were working in our clinic at that time participated in the study (70%). Half of these were assigned to structured written feedback after every autonomously performed operation. Additionally, all participants performed structured written proper feedback according to the OSATS concept. The primary endpoint was the feasibility of the OSATS concept in our clinic; secondary endpoints were the benefits for the residents and the differences between external and self-evaluation.
RESULTS
The OSATS-concept was easily implemented in our clinic and met wide acceptance. Evaluation was performed after a mean of 70% of operations. External evaluation was regarded as more beneficial for residents than self-evaluation. Structured written evaluation according to the OSATS concept was not time-consuming (< 3 minutes) and most residents (86%) supported permanent implementation of the OSATS concept in our clinic.
CONCLUSION
The OSATS concept is a suitable approach to provide structured feedback to residents in continuous education. It can easily be implemented in resident education in Germany. Structured, written feedback by senior physicians is perceived as beneficial by residents.",2020,"The primary endpoint was the feasibility of the OSATS concept in our clinic; secondary endpoints were the benefits for the residents and the differences between external and self-evaluation.
",['Seven out of 10 residents that were working in our clinic at that time participated in the study (70'],[],['feasibility of the OSATS concept'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0557351', 'cui_str': 'Employed'}]",[],[],,0.0144992,"The primary endpoint was the feasibility of the OSATS concept in our clinic; secondary endpoints were the benefits for the residents and the differences between external and self-evaluation.
","[{'ForeName': 'Sophia M', 'Initials': 'SM', 'LastName': 'Schmitz', 'Affiliation': 'Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Aachen, Deutschland.'}, {'ForeName': 'Tom F', 'Initials': 'TF', 'LastName': 'Ulmer', 'Affiliation': 'Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Aachen, Deutschland.'}, {'ForeName': 'Steven W M', 'Initials': 'SWM', 'LastName': 'Olde Damink', 'Affiliation': 'Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Aachen, Deutschland.'}, {'ForeName': 'Ulf P', 'Initials': 'UP', 'LastName': 'Neumann', 'Affiliation': 'Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Aachen, Deutschland.'}, {'ForeName': 'Anjali A', 'Initials': 'AA', 'LastName': 'Roeth', 'Affiliation': 'Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Aachen, Deutschland.'}]",Zentralblatt fur Chirurgie,['10.1055/a-1265-7384']
2104,33152805,School Mental Health Curriculum Effects on Peer Violence Victimization and Perpetration: A Cluster-Randomized Trial.,"BACKGROUND
Addressing school violence is an important public health goal. To assess the role of school mental health curricula in violence prevention, we evaluated effects of an anti-stigma curriculum on violence victimization/perpetration.
METHODS
An ethnically/socioeconomically diverse sample of 751 sixth-graders (mean age 11.5 years) across 14 schools in Texas were block-randomized by school (2011-2012) to receive singly or in combination: (1) a mental illness anti-stigma curriculum; (2) contact with 2 young adults with mental illness; or (3) merged control (printed materials/no intervention). Pre- and post-test assessments were self-completed during health education classes; prior to randomization, 484 (64.5%) agreed to 2-year, home-based longitudinal assessments. Statistical models tested short- and long-term effects on physical, verbal, and relational/social violence victimization/perpetration.
RESULTS
At 1-month post-test, students who received the curriculum versus control made fewer verbal threats (p < .05). Those with high-level mental health symptoms in the curriculum group versus control used less violence overall and received fewer verbal threats from peers short-term (p < .05). Curriculum effects of reducing violence perpetration sustained long-term among adolescents with high-symptoms (p < .01). The comparator contact intervention was ineffective short- and long-term.
CONCLUSIONS
Implementing efficacious mental health curricula can serve as a multi-pronged strategy with anti-bulling efforts to prevent violence and improve mental health.",2020,Curriculum effects of reducing violence perpetration sustained long-term among adolescents with high-symptoms (p < .01).,"['Peer Violence Victimization and Perpetration', 'school mental health curricula in violence prevention', 'An ethnically/socioeconomically diverse sample of 751 sixth-graders (mean age 11.5\u2009years) across 14 schools in Texas were block-randomized by school (2011-2012) to', 'adolescents with high-symptoms (p\u2009<\u2009.01']","['receive singly or in combination: (1) a mental illness anti-stigma curriculum; (2) contact with 2 young adults with mental illness; or (3) merged control (printed materials/no intervention', 'anti-stigma curriculum']","['verbal threats', 'physical, verbal, and relational/social violence victimization/perpetration']","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}]",2.0,0.0578365,Curriculum effects of reducing violence perpetration sustained long-term among adolescents with high-symptoms (p < .01).,"[{'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'DuPont-Reyes', 'Affiliation': 'Assistant Professor, (melissadr@tamu.edu), Department of Epidemiology and Biostatistics School of Public Health, Texas A&M University, 1266 TAMU, College Station, TX 77845.'}, {'ForeName': 'Alice P', 'Initials': 'AP', 'LastName': 'Villatoro', 'Affiliation': 'Research Assistant Professor, (avillato@austin.utexas.edu), Latino Research Institute, The University of Texas at Austin, 210 W. 24th St., Stop F9200, Austin, TX, 78712.'}, {'ForeName': 'Jo C', 'Initials': 'JC', 'LastName': 'Phelan', 'Affiliation': 'Professor Emerita of Public Health, (jcp13@columbia.edu), Columbia University, New York, NY.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Painter', 'Affiliation': 'Program Specialist, (kirstin.painter@acl.hhs.gov), Office of Research Sciences, National Institute of Independent Living, Disability and Rehabilitation Research, 330 C Street SW, Washington DC 20201.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Barkin', 'Affiliation': 'Principal Owner, (kay@barkincomm.com), Barkin Communications, 101 Canterbury Street Euless, TX 7603.'}, {'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Link', 'Affiliation': 'Distinguished Professor, (brucel@ucr.edu), School of Public Policy and Department of Sociology, University of California, Riverside, 4159 Interdisciplinary South, Riverside, CA, 92507.'}]",The Journal of school health,['10.1111/josh.12978']
2105,33152965,Higher doses of fentanyl during bronchoscopy in infants significantly reduces perioperative complication rates.,"OBJECTIVES
The specific aim of this study was to assess the effect of higher fentanyl doses on reducing perioperative complication rates among infants undergoing rigid bronchoscopy.
METHODS
Sixty children who underwent rigid bronchoscopy for foreign body removal were enlisted in our 2-year prospective cohort study at the Department of ENT and Head & Neck Surgery, Medical University - Sofia. Infants were randomly distributed into two groups according to fentanyl dose (group 1 - 1-2 μg/kg vs group 2 - 6-7 μg/kg). Hemodynamic parameters and perioperative complications were recorded.
RESULTS
The mean age of the whole study group was 1.94 years. Five minutes prior to anesthesia both groups presented with similar parameter levels and no statistically significant difference was found. In contrast, at 5th and 10th minutes after intubation the heart rate, systolic and diastolic blood pressure levels were recorded at significantly higher levels in group 1 compared to group 2 (p = .000). Same results were obtained five minutes after extubation. Additionally, after performing the Pearson chi-Square test we found that bronchospasm and laryngospasm were significantly more frequent among patients from group 1 infused with lower dosage of fentanyl in comparison to the infants that were administered with a higher dose of this medication (p = .020). Phi and Cramer's V tests both display moderate strength of this association (V = 0.302).
CONCLUSION
In the current study we propose refinement of current anesthetic protocols by using higher doses of fentanyl during rigid bronchoscopy in infants. This significantly reduces perioperative complication rates and improves intraoperative hemodynamics without presenting any newly formed risks.",2020,Five minutes prior to anesthesia both groups presented with similar parameter levels and no statistically significant difference was found.,"['infants', 'Sixty children who underwent', 'for foreign body removal were enlisted in our 2-year prospective cohort study at the Department of ENT and Head & Neck Surgery, Medical University - Sofia', 'infants undergoing rigid bronchoscopy']","['rigid bronchoscopy', 'fentanyl']","['bronchospasm and laryngospasm', 'perioperative complication rates', 'Hemodynamic parameters and perioperative complications', 'heart rate, systolic and diastolic blood pressure levels', 'intraoperative hemodynamics']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184937', 'cui_str': 'Removal of foreign body'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0185773', 'cui_str': 'Operation on neck'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0445270', 'cui_str': 'Sofia'}, {'cui': 'C0396451', 'cui_str': 'Rigid therapeutic bronchoscopy'}]","[{'cui': 'C0396451', 'cui_str': 'Rigid therapeutic bronchoscopy'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0023066', 'cui_str': 'Laryngeal spasm'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]",60.0,0.0435927,Five minutes prior to anesthesia both groups presented with similar parameter levels and no statistically significant difference was found.,"[{'ForeName': 'Marinov', 'Initials': 'M', 'LastName': 'Ts', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Medical University-Sofia, Sofia, Bulgaria.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Belitova', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Medical University-Sofia, Sofia, Bulgaria.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Popov', 'Affiliation': 'Department of ENT and Head and Neck Surgery, Medical University-Sofia, Sofia, Bulgaria. Electronic address: popov@todorpopov.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110374']
2106,33153062,A Low-Intensity Internet-Based Intervention Focused on the Promotion of Positive Affect for the Treatment of Depression in Spanish Primary Care: Secondary Analysis of a Randomized Controlled Trial.,"Background : A large number of low-intensity Internet-based interventions (IBIs) for the treatment of depression have emerged in Primary Care; most of them focused on decreasing negative emotions. However, recent studies have highlighted the importance of addressing positive affect (PA) as well. This study is a secondary analysis of a randomized control trial. We examine the role of an IBI focused on promoting PA in patients with depression in Primary Care (PC). The specific objectives were to explore the profile of the patients who benefit the most and to analyze the change mechanisms that predict a significantly greater improvement in positive functioning measures. Methods : 56 patients were included. Measures of depression, affect, well-being, health-related quality of life, and health status were administered. Results : Participants who benefited the most were those who had lower incomes and education levels and worse mental health scores and well-being at baseline (7.9%-39.5% of explained variance). Improvements in depression severity and PA were significant predictors of long-term change in well-being, F (3,55) = 17.78, p < 0.001, R 2 = 47.8%. Conclusions : This study highlights the importance of implementing IBIs in PC and the relevance of PA as a key target in Major Depressive Disorder treatment.",2020,"Improvements in depression severity and PA were significant predictors of long-term change in well-being, F (3,55) =","['Spanish Primary Care', 'Methods : 56 patients were included', 'patients with depression in Primary Care (PC']",[' '],"['education levels and worse mental health scores', 'depression severity and PA', 'depression, affect, well-being, health-related quality of life, and health status']","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",[],"[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",56.0,0.155559,"Improvements in depression severity and PA were significant predictors of long-term change in well-being, F (3,55) =","[{'ForeName': 'Mª Dolores', 'Initials': 'MD', 'LastName': 'Vara', 'Affiliation': 'Polibienestar Research Institute, University of Valencia, 46022 Valencia, Spain.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Mira', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, Faculty of Psychology, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Miragall', 'Affiliation': 'CIBERObn Physiopathology of Obesity and Nutrition, Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'CIBERObn Physiopathology of Obesity and Nutrition, Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'CIBERObn Physiopathology of Obesity and Nutrition, Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, E-07122 Palma de Mallorca, Spain.""}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Riera-Serra', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, E-07122 Palma de Mallorca, Spain.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'García-Campayo', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network, RedIAPP, 28029 Madrid, Spain.'}, {'ForeName': 'Fermín', 'Initials': 'F', 'LastName': 'Mayoral-Cleries', 'Affiliation': 'Mental Health Unit, Hospital Regional of Malaga, Biomedicine Research Institute (IBIMA), 29010 Málaga, Spain.'}, {'ForeName': 'Rosa Mª', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'Polibienestar Research Institute, University of Valencia, 46022 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17218094']
2107,33153433,The detrimental impacts of negative age stereotypes on the episodic memory of older adults: does social participation moderate the effects?,"BACKGROUND
Older adults' cognitive abilities can be impaired through priming of negative age stereotypes. However, it is unclear whether the effects of negative priming can be extended to episodic memory, which is believed to be the most age-sensitive type among the long-term memory systems, in Asian populations. Social participation has recently emerged as a potential protective factor for maintaining the cognitive function of older adults. The purpose of this study was to examine the effects of negative age stereotype priming on episodic memory and the moderating role of social participation in the priming effect.
METHODS
A total of 105 community-dwelling older adults residing in Hong Kong were randomly allocated to two experimental conditions. Participants were primed either with negative age stereotype words (n = 53) or neutral words (n = 52) using an implicit priming task. Episodic memory performance was assessed using the Hong Kong List Learning Task (HKLLT), which includes total learning, two delayed recalls and a recognition task. Analysis of covariance (ANCOVA) was used to assess group differences in the priming task and memory performance, while a series of moderation analyses were performed to examine the moderating effects of social participation.
RESULTS
The group that received negative age stereotype priming performed significantly worse than the group that received neutral words in their episodic memory test. Additional analyses showed that socially active individuals might be less prone to the effects of negative age stereotypes for the recognition task only.
CONCLUSIONS
Older adults who are more socially active might be more immune to the effects of negative age stereotype priming on episodic memory. These results provide initial support for the hypothesis that social participation might act as an effective strategy to ward against negative age stereotype priming.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT04202120 (first posted December 17, 2019), (Retrospectively registered).",2020,The group that received negative age stereotype priming performed significantly worse than the group that received neutral words in their episodic memory test.,"['older adults', 'Older adults', '105 community-dwelling older adults residing in Hong Kong']","['negative age stereotype words (n\u2009=\u200953) or neutral words (n\u2009=\u200952) using an implicit priming task', 'negative age stereotype priming']",['Episodic memory performance'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}]","[{'cui': 'C0561843', 'cui_str': 'Episodic memory'}]",105.0,0.0286695,The group that received negative age stereotype priming performed significantly worse than the group that received neutral words in their episodic memory test.,"[{'ForeName': 'Stephen C Y', 'Initials': 'SCY', 'LastName': 'Chan', 'Affiliation': 'The Open University of Hong Kong, Good Shepherd Street, Ho Man Tin, Kowloon, Hong Kong. scychan@ouhk.edu.hk.'}, {'ForeName': 'Alma M L', 'Initials': 'AML', 'LastName': 'Au', 'Affiliation': 'The Hong Kong Polytechnic University Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Simon M K', 'Initials': 'SMK', 'LastName': 'Lai', 'Affiliation': 'The Hong Kong Polytechnic University Hung Hom, Kowloon, Hong Kong.'}]",BMC geriatrics,['10.1186/s12877-020-01833-z']
2108,33153434,"Effect of complementary feeding behavior change communication delivered through community-level actors on the time of initiation of complementary foods in rural communities of West Gojjam zone, Northwest Ethiopia: a cluster-randomized controlled trial.","BACKGROUND
Attaining the recommended level of complementary feeding practices remains a serious challenge in many developing countries. Complementary foods are usually untimely initiated, which has adverse consequences on the growth, development, and survival of infants. The focus of most studies conducted worldwide seemed to be on the effect of behavior change interventions on the adequacy of complementary diets; but not on the timing of initiations. Moreover, many of the interventions targeted only mothers/caregivers of infants, and studies that engaged the family members are scarce. This study aimed to evaluate the effectiveness of complementary feeding behavior change communication delivered through women development army leaderson the time of initiation of complementary foods.
METHODS
We conducted a cluster-randomized controlled trial in rural communities of West Gojjam Zone, Northwest Ethiopia from February 2017 to March 2018. A total of 16 geographic clusters were selected. Trial participants in the intervention group received complementary feeding behavior change intervention for 9 months whereas those in the control group received only the usual health care. Trained women development army leaders delivered the intervention. A pre-tested, structured interviewer-administered questionnaire was used for data collection. Generalized estimated equation (GEE) regression and survival analyses were used to test differences in time of initiation of complementary food between the study groups.
RESULTS
The intervention significantly improved the likelihood of timely initiation of complementary food by 22 percentage points [RR: 2.6; 95% CI: 1.78-5.86], and reduced the risk of late initiations by 19 percentage points [RR: 2.8; 95% CI: 1.83-4.37]. The complementary food initiation survival curve for the control group after 6 months was constantly above the curve than for the intervention group. The median age at the introduction of complementary food for infants was 6 months in the intervention group, and 6.7 months in the control group and the difference was statistically significant (P-value < 0.001).
CONCLUSIONS
Complementary feeding behavior change communication improved the rate of timely initiation of complementary foods and reduced the risk of late initiations.
TRIAL REGISTRATION
ClinicalTrials.gov , NCT03488680 . Registered 5 April 2018-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03488680 .",2020,The complementary food initiation survival curve for the control group after 6 months was constantly above the curve than for the intervention group.,"['Trained women development army leaders', 'rural communities of West Gojjam Zone, Northwest Ethiopia from February 2017 to March 2018', 'A total of 16 geographic clusters', 'rural communities of West Gojjam zone, Northwest Ethiopia']","['complementary feeding behavior change communication', 'complementary feeding behavior change communication delivered through community-level actors', 'complementary feeding behavior change intervention', 'control group received only the usual health care']","['initiation survival curve', 'risk of late initiations', 'likelihood of timely initiation of complementary food']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",,0.0901151,The complementary food initiation survival curve for the control group after 6 months was constantly above the curve than for the intervention group.,"[{'ForeName': 'Chalachew', 'Initials': 'C', 'LastName': 'Abiyu', 'Affiliation': 'Faculty of Public Health, Department of Nutrition and Dietetics, Jimma University, Jimma, Ethiopia. chalachewabiyu@yahoo.com.'}, {'ForeName': 'Tefera', 'Initials': 'T', 'LastName': 'Belachew', 'Affiliation': 'Faculty of Public Health, Department of Nutrition and Dietetics, Jimma University, Jimma, Ethiopia.'}]",BMC pediatrics,['10.1186/s12887-020-02396-z']
2109,33153439,The effect of side-alternating vibration therapy on mobility and health outcomes in young children with mild to moderate cerebral palsy: design and rationale for the randomized controlled study.,"BACKGROUND
Cerebral palsy (CP) is the most common cause of physical disability in early childhood. Vibration therapy (VT) is a promising rehabilitation approach for children with CP with potential to impact mobility, bone and muscle health as demonstrated by extant research. However, it is still unclear how long therapy must be conducted for and what the optimal vibration frequency is in order to gain health benefits.
METHODS/DESIGN
The study is a randomized clinical trial evaluating and comparing the effects of two vibration frequency (20 Hz vs 25 Hz) and duration protocols (12 weeks vs 20 weeks) of side-alternating VT on mobility and other health parameters in children with CP. Children aged 5-12 years old with CP and GMFCS level I-III who are able to understand instruction and safely stand are eligible for the study. Exclusion criteria include bone fracture within 12 weeks of enrolment; acute conditions; the history of significant organic disease; the history of taking anabolic agents, glucocorticoids, growth hormone, and botulinum toxin injection into lower limbs within 3 months of enrolment. All participants will act as their own control with a 12-week lead-in period prior to intervention. The intervention period will consist of 20 weeks of home- or school-based VT 9 min per day, 4 times a week. After the baseline assessment, participants will be randomized to either a 20 Hz or 25 Hz vibration-frequency group. The primary outcome is mobility measured by a 6-min walking test, with analysis performed on the principle of intention to treat. Secondary outcomes include body composition, muscle strength, physical activity level, balance, gross motor function, respiratory function, and quality of life. Participants will undergo four assessment visits over the study period: baseline, at weeks 12, 24, and 32.
DISCUSSION
The results of the study will provide evidence-based insights into the health benefits of side-alternating VT as a therapeutic tool in young children with cerebral palsy. The investigation of different vibration training protocols will help define the optimal parameters of intervention protocols (duration, frequency) of side-alternating VT to maximize outcomes on the health of 5-12-year-old children with CP.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry (ANZCTR): 12618002026202 (Registration date 18/12/2018).",2020,"Vibration therapy (VT) is a promising rehabilitation approach for children with CP with potential to impact mobility, bone and muscle health as demonstrated by extant research.","['Children aged 5-12\u2009years old with CP and GMFCS level I-III who are able to understand instruction and safely stand are eligible for the study', 'young children with mild to moderate cerebral palsy', 'young children with cerebral palsy', 'Participants will undergo four assessment visits over the study period: baseline, at weeks 12, 24, and 32', 'children with CP', 'Cerebral palsy (CP', '5-12-year-old children with CP']","['20\u2009Hz or 25\u2009Hz vibration-frequency group', 'vibration frequency (20\u2009Hz vs 25\u2009Hz) and duration protocols (12\u2009weeks vs 20\u2009weeks) of side-alternating VT', 'vibration training protocols', 'side-alternating vibration therapy', 'Vibration therapy (VT']","['mobility measured by a 6-min walking test, with analysis performed on the principle of intention to treat', 'body composition, muscle strength, physical activity level, balance, gross motor function, respiratory function, and quality of life', 'mobility and health outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0305338,"Vibration therapy (VT) is a promising rehabilitation approach for children with CP with potential to impact mobility, bone and muscle health as demonstrated by extant research.","[{'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Adaikina', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand. a.adaikina@auckland.ac.nz.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Hofman', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Silmara', 'Initials': 'S', 'LastName': 'Gusso', 'Affiliation': 'Department of Exercise Sciences, University of Auckland, Auckland, New Zealand.'}]",BMC pediatrics,['10.1186/s12887-020-02377-2']
2110,33153461,Standardized multimodal intervention for stress-induced exhaustion disorder: an open trial in a clinical setting.,"BACKGROUND
Long-term sick-leave due to stress-related ill-health is increasing in several economically developed countries. Even though different forms of interventions are administered in regular care for stress-related disorders, such as Stress-induced Exhaustion disorder (SED), the scientific evidence for the effectiveness of such treatments is sparse. The objective of this study was to explore changes in SED-symptoms and return-to-work-rates in a large group of SED-patients participating in a standardized Multimodal intervention (MMI) in a clinical setting.
METHOD
This open clinical trial tracked 390 patients who fulfilled the criteria for SED undergoing a 24-week MMI, including return-to-work-strategies. Before inclusion, all patients underwent a multi-professional assessment by a team of licensed physicians, licensed psychologists, and licensed physiotherapists. Self-rated questionnaires were administered before treatment, at treatment-start, mid-treatment, post-treatment, and at 12-month follow-up. Within-group change was evaluated over time with mixed-effects models. Beyond different symptoms, working time, sick-leave compensation, and adverse effects were also measured.
RESULTS
There were significant improvements in symptoms of SED, burnout, anxiety, depression, and insomnia, with large within-group effect sizes (d = 0.91-1.76), improvements that were maintained at 12-month follow-up. Furthermore, there was a significant increase in quality of life and large improvements in average working time and sick-leave compensation. Some adverse effects were reported, mainly concerning an increase in stress, anxiety, and worry.
CONCLUSION
SED-patients participating in this standardized MMI reported large symptom alleviation, increased working time and reduced sick-leave compensation, indicating a beneficial treatment. There were some adverse effects, but no more so than other psychological treatments. This study confirms previous findings that high levels of depression and anxiety decrease to sub-clinical levels during treatment, while symptoms of SED also decline, yet still persists above sub-clinical levels at 12-month follow-up. On the whole, this open clinical trial suggests that a standardized MMI, administered in a clinical setting, improves symptoms and return-to-work rates in a clinically representative SED-population.
TRIAL REGISTRATION
This study was registered on Clinicaltrials.gov 2017.12.02 (Identifier: NCT03360136 ).",2020,"SED-patients participating in this standardized MMI reported large symptom alleviation, increased working time and reduced sick-leave compensation, indicating a beneficial treatment.","['large group of SED-patients participating in a standardized Multimodal intervention (MMI) in a clinical setting', '390 patients who fulfilled the criteria for SED undergoing a 24-week MMI, including return-to-work-strategies', 'patients underwent a multi-professional assessment by a team of licensed physicians, licensed psychologists, and licensed physiotherapists']",['Standardized multimodal intervention'],"['symptoms of SED, burnout, anxiety, depression, and insomnia, with large within-group effect sizes', 'SED-symptoms and return-to-work-rates', 'large symptom alleviation, increased working time and reduced sick-leave compensation', 'adverse effects', 'stress-induced exhaustion disorder', 'average working time and sick-leave compensation', 'working time, sick-leave compensation, and adverse effects', 'quality of life', 'stress, anxiety, and worry']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0233481', 'cui_str': 'Worried'}]",390.0,0.110524,"SED-patients participating in this standardized MMI reported large symptom alleviation, increased working time and reduced sick-leave compensation, indicating a beneficial treatment.","[{'ForeName': 'Jakob Clason', 'Initials': 'JC', 'LastName': 'van de Leur', 'Affiliation': 'Department of Psychology, Uppsala University, Von Kraemers allé 1A, SE-752 37, Uppsala, Sweden. jakob.clason-vandeleur@psyk.uu.se.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Buhrman', 'Affiliation': 'Department of Psychology, Uppsala University, Von Kraemers allé 1A, SE-752 37, Uppsala, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Åhs', 'Affiliation': 'Department of Psychology and Social Work, Mid Sweden University, Kunskapens väg 1, SE- 831 40, Östersund, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rozental', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Tomtebodavägen 18A, SE-171 76, Stockholm, Sweden.'}, {'ForeName': 'Gunilla Brodda', 'Initials': 'GB', 'LastName': 'Jansen', 'Affiliation': 'Division of Rehabilitation Medicine, Department of Clinical Sciences, Karolinska Institute Danderyds University Hospital, SE-182 57, Stockholm, Sweden.'}]",BMC psychiatry,['10.1186/s12888-020-02907-3']
2111,33153482,"A collaborative care psychosocial intervention to improve late life depression in socioeconomically deprived areas of Guarulhos, Brazil: the PROACTIVE cluster randomised controlled trial protocol.","BACKGROUND
The elderly population has been growing in most low- and middle-income countries (LMIC), and depression is a common condition among these populations. The lack of integration between mental health and primary healthcare services and the shortage of mental health specialists in the public health system contribute to underdiagnosis and undertreatment of depression. One of the strategies to reduce this gap is task shifting and collaborative care treatments. This study therefore aims to evaluate the effectiveness and cost-effectiveness of a collaborative care psychosocial intervention to improve the clinical management of depression among elderly people in poor neighbourhoods in Guarulhos, Brazil.
METHODS
Two-arm, cluster randomised controlled trial with Basic Health Units as the clusters and a 1:1 allocation ratio. Twenty Basic Health Units have been randomly selected and randomised to control or intervention arms. We aim to recruit 1440 adults (72 per cluster) aged 60 years or over identified with depression (9-item Patient Health Questionnaire (PHQ-9) score ≥ 10). The control arm participants will receive an enhanced usual care, while the intervention arm participants will receive an enhanced usual care and a 17-week psychosocial intervention programme delivered at home by community health workers with the help of an application installed on tablet computers. The primary outcome is the proportion with depression recovery (PHQ-9 < 10) at 8 months' follow-up. We will also assess the maintenance of any earlier clinical gains and the cost-effectiveness of the intervention at 12 months.
DISCUSSION
This is the first randomised trial to investigate a collaborative care intervention to treat depression among poor elderly in LMIC/Latin America. This is a major public health problem worldwide, but in these countries, there are no locally tested, evidence-based interventions available to date.
TRIAL REGISTRATION
International Standard Randomised Controlled Trial Number ISRCTN57805470 . Registered on 25 April 2019.",2020,"This study therefore aims to evaluate the effectiveness and cost-effectiveness of a collaborative care psychosocial intervention to improve the clinical management of depression among elderly people in poor neighbourhoods in Guarulhos, Brazil.
","['1440 adults (72 per cluster) aged 60\u2009years or over identified with depression (9-item Patient Health Questionnaire (PHQ-9) score\u2009≥\u200910', 'Twenty Basic Health Units', 'socioeconomically deprived areas of Guarulhos, Brazil', 'poor elderly in LMIC/Latin America', 'elderly people in poor neighbourhoods in Guarulhos, Brazil']","['collaborative care intervention', 'enhanced usual care, while the intervention arm participants will receive an enhanced usual care and a 17-week psychosocial intervention programme delivered at home by community health workers with the help of an application installed on tablet computers', 'collaborative care psychosocial intervention']","['effectiveness and cost-effectiveness', 'late life depression', 'proportion with depression recovery (PHQ-9\u2009<\u200910']","[{'cui': 'C4517576', 'cui_str': '1440'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0050288', 'cui_str': 'A 17'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C4045980', 'cui_str': 'Tablet Computers'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]",,0.154396,"This study therefore aims to evaluate the effectiveness and cost-effectiveness of a collaborative care psychosocial intervention to improve the clinical management of depression among elderly people in poor neighbourhoods in Guarulhos, Brazil.
","[{'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Scazufca', 'Affiliation': 'Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil. scazufca@usp.br.'}, {'ForeName': 'Carina Akemi', 'Initials': 'CA', 'LastName': 'Nakamura', 'Affiliation': 'Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'University of Bristol Medical School, Bristol, England.'}, {'ForeName': 'Maiara Garcia', 'Initials': 'MG', 'LastName': 'Henrique', 'Affiliation': 'Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Antônio', 'Initials': 'A', 'LastName': 'Seabra', 'Affiliation': 'Departamento de Engenharia Eletrica, Escola Politecnica, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ehidee Gomez', 'Initials': 'EG', 'LastName': 'La Rotta', 'Affiliation': 'Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Renato M', 'Initials': 'RM', 'LastName': 'Franzin', 'Affiliation': 'Departamento de Engenharia Eletrica, Escola Politecnica, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Daniele Ferreira', 'Initials': 'DF', 'LastName': 'Martins', 'Affiliation': 'Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Pepijn', 'Initials': 'P', 'LastName': 'Van de Ven', 'Affiliation': 'Faculty of Science and Engeneering, University of Limerick, Limerick, England.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'University of Bristol Medical School, Bristol, England.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Institute of Psychiatry Psychology and Neurosciences, King's College London, London, England. ricardo.araya@kcl.ac.uk.""}]",Trials,['10.1186/s13063-020-04826-w']
2112,33153578,Influence of LDL-Cholesterol Lowering on Cardiovascular Outcomes in Patients With Diabetes Mellitus Undergoing Coronary Revascularization.,"BACKGROUND
Elevated low-density lipoprotein cholesterol (LDL-C) is associated with increased cardiovascular events, especially in high-risk populations.
OBJECTIVES
This study sought to evaluate the influence of LDL-C on the incidence of cardiovascular events either following a coronary revascularization procedure (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or optimal medical therapy alone in patients with established coronary heart disease and type 2 diabetes (T2DM).
METHODS
Patient-level pooled analysis of 3 randomized clinical trials was undertaken. Patients with T2DM were categorized according to the levels of LDL-C at 1 year following randomization. The primary endpoint was major adverse cardiac or cerebrovascular events ([MACCE] the composite of all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke).
RESULTS
A total of 4,050 patients were followed for a median of 3.9 years after the index 1-year assessment. Patients whose 1-year LDL-C remained ≥100 mg/dl experienced higher 4-year cumulative risk of MACCE (17.2% vs. 13.3% vs. 13.1% for LDL-C between 70 and <100 mg/dl and LDL-C <70 mg/dl, respectively; p = 0.016). When compared with optimal medical therapy alone, patients with PCI experienced a MACCE reduction only if 1-year LDL-C was <70 mg/dl (hazard ratio: 0.61; 95% confidence interval: 0.40 to 0.91; p = 0.016), whereas CABG was associated with improved outcomes across all 1-year LDL-C strata. In patients with 1-year LDL-C ≥70 mg/dl, patients undergoing CABG had significantly lower MACCE rates as compared with PCI.
CONCLUSIONS
In patients with coronary heart disease with T2DM, lower LDL-C at 1 year is associated with improved long-term MACCE outcome in those eligible for either PCI or CABG. When compared with optimal medical therapy alone, PCI was associated with MACCE reductions only in those who achieved an LDL-C <70 mg/dl.",2020,"Patients whose 1-year LDL-C remained ≥100 mg/dl experienced higher 4-year cumulative risk of MACCE (17.2% vs. 13.3% vs. 13.1% for LDL-C between 70 and <100 mg/dl and LDL-C <70 mg/dl, respectively; p = 0.016).","['Patients', 'patients with coronary heart disease with T2DM, lower LDL-C at 1 year', 'Diabetes Mellitus Undergoing Coronary Revascularization', 'Patients with T2DM', 'patients with established coronary heart disease and type 2 diabetes (T2DM', '4,050 patients', 'patients with 1-year LDL-C\xa0≥70']","['LDL-C', 'coronary revascularization procedure (percutaneous coronary intervention [PCI', 'coronary artery bypass grafting [CABG', 'LDL-Cholesterol Lowering']","['MACCE reduction only if 1-year LDL-C', '1-year LDL-C', 'MACCE rates', 'MACCE reductions', 'major adverse cardiac or cerebrovascular events ([MACCE] the composite of all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke', 'Cardiovascular Outcomes', '4-year cumulative risk of MACCE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",4050.0,0.0841526,"Patients whose 1-year LDL-C remained ≥100 mg/dl experienced higher 4-year cumulative risk of MACCE (17.2% vs. 13.3% vs. 13.1% for LDL-C between 70 and <100 mg/dl and LDL-C <70 mg/dl, respectively; p = 0.016).","[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Peter Munk Cardiac Centre and the Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, Ontario, Canada. Electronic address: Michael.Farkouh@uhn.ca.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Godoy', 'Affiliation': 'Peter Munk Cardiac Centre and the Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, Ontario, Canada; Instituto do Coracao, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil. Electronic address: https://twitter.com/lucascgodoy.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Brooks', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'G B John', 'Initials': 'GBJ', 'LastName': 'Mancini', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Vlachos', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': 'Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Flora S', 'Initials': 'FS', 'LastName': 'Siami', 'Affiliation': 'Boston, Massachusetts.'}, {'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Hartigan', 'Affiliation': 'Yale University and VA West Haven, West Haven, Connecticut.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Frye', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': 'Boston University School of Medicine, VA New England Healthcare System, VA Boston-Jamaica Plain Campus, Boston, Massachusetts.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York; Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.09.536']
2113,33153707,Topical versus interlesional mitomycin C in auricular keloids.,"BACKGROUND
The Keloid is an elevated fibrous scar that may extend beyond the borders of the original wound.
OBJECT
To compare between topical and intralesional mitomycin C in the treatment of auricular keloids.
PATIENTS AND METHODS
Prospective randomized study in which 40 patients with auricular keloids were included. The patients were divided into 2 groups, Group I included 32 patients who underwent topical mitomycin C application after the surgical removal of the auricular keloids, while Group II included 8 cases who underwent intra-lesional injection of mitomycin C after surgical removal of the auricular keloids.
RESULTS
The two groups showed no significant difference regarding patient or lesion criteria (p>.05). VSS decreased significantly from 10.63 and 11.0 down to 1.38 and 3.0 after treatment in the topical and intra-lesional groups respectively (p<.001). However, greater improvement and satisfaction was detected in the topical group.
CONCLUSION
Both topical and intra-lesional mitomycin C injection are effective methods in managing auricular keloids. However, better VSS scores and patient satisfaction are reported with topical administration.",2020,The two groups showed no significant difference regarding patient or lesion criteria (p>.05).,"['40 patients with auricular keloids were included', 'auricular keloids']","['mitomycin C', 'Topical versus interlesional mitomycin C', 'topical mitomycin C application', 'topical and intra-lesional mitomycin C injection', 'intralesional mitomycin C']","['VSS', 'satisfaction', 'VSS scores and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0022548', 'cui_str': 'Keloid'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",40.0,0.0531407,The two groups showed no significant difference regarding patient or lesion criteria (p>.05).,"[{'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Mandour', 'Affiliation': 'Faculty of Medicine, Benha University, Benha, Egypt. Electronic address: ghader_massoud@yahoo.com.'}, {'ForeName': 'Hossam', 'Initials': 'H', 'LastName': 'Bake', 'Affiliation': 'Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Esmael', 'Initials': 'E', 'LastName': 'Mofty', 'Affiliation': 'Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Ramadan', 'Affiliation': 'Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Gomaa', 'Affiliation': 'Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Essam', 'Initials': 'E', 'LastName': 'Akl', 'Affiliation': 'Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elrefae', 'Affiliation': 'Faculty of Medicine, Benha University, Benha, Egypt.'}]",Acta otorrinolaringologica espanola,['10.1016/j.otorri.2020.06.005']
2114,33148672,Immune infiltrate in the primary tumor predicts effect of adjuvant radiotherapy in breast cancer; results from the randomized SweBCG91RT trial.,"PURPOSE
Tumor-infiltrating immune cells play a key role in tumor progression. The purpose of this study was to analyze if the immune infiltrate predicts benefit from postoperative radiotherapy (RT) in a large randomized breast cancer RT trial.
EXPERIMENTAL DESIGN
In the SweBCG91RT trial, patients with stage I and II breast cancer were randomized to breast conserving surgery (BCS) and postoperative RT or to BCS only and followed for a median time of 15.2 years. The primary tumor immune infiltrate was quantified through two independent methods; immunohistochemistry (IHC) and gene expression profiling. For IHC analyses, the absolute stromal area occupied by CD8+ T cells and FOXP3+ T cells, respectively, was used to define the immune infiltrate. For gene expression analyses, immune cells found to be prognostic in independent datasets were pooled into two groups consisting of antitumoral- and protumoral immune cells, respectively.
RESULTS
An antitumoral immune response in the primary tumor was associated with a reduced risk of breast cancer recurrence and predicted less benefit from adjuvant RT. The interaction between RT and immune phenotype was significant for any recurrence in both the IHC and gene expression analyses (p=0.039 and p=0.035) and was also significant for IBTR in the gene expression analyses (p=0.025).
CONCLUSIONS
Patients with an antitumoral immune infiltrate in the primary tumor have a reduced risk of any recurrence and may derive less benefit from adjuvant RT. These results may impact decisions regarding postoperative RT in early breast cancer.",2020,"For IHC analyses, the absolute stromal area occupied by CD8+ T cells and FOXP3+ T cells, respectively, was used to define the immune infiltrate.","['breast cancer', 'patients with stage I and II breast cancer']","['adjuvant radiotherapy', 'postoperative radiotherapy (RT', 'breast conserving surgery (BCS) and postoperative RT or to BCS']","['reduced risk of breast cancer recurrence', 'immunohistochemistry (IHC) and gene expression profiling']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}]","[{'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0752248', 'cui_str': 'Transcriptome Profiling'}]",,0.0623517,"For IHC analyses, the absolute stromal area occupied by CD8+ T cells and FOXP3+ T cells, respectively, was used to define the immune infiltrate.","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Stenmark Tullberg', 'Affiliation': 'Department of Oncology, University of Gothenburg.'}, {'ForeName': 'Henri A J', 'Initials': 'HAJ', 'LastName': 'Puttonen', 'Affiliation': 'Sahlgrenska University Hospital, Department of Pathology.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sjöström', 'Affiliation': 'Radiation Oncology, University of California, San Francisco.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at Univerity of Gothenburg.'}, {'ForeName': 'S Laura', 'Initials': 'SL', 'LastName': 'Chang', 'Affiliation': 'PFS Genomics.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'Radiation Oncology, Helen Diller Comprehensive Cancer Center, University of California, San Francisco.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Speers', 'Affiliation': 'Radiation Oncology, University of Michigan-Ann Arbor.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Pierce', 'Affiliation': 'Radiation Oncology, University of Michigan-Ann Arbor.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lundstedt', 'Affiliation': 'Sahlgrenska University Hospital.'}, {'ForeName': 'Fredrika', 'Initials': 'F', 'LastName': 'Killander', 'Affiliation': 'Department of Oncology, Lund University.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Niméus', 'Affiliation': 'Oncology and Pathology, Clinical Sciences, Lund University.'}, {'ForeName': 'Anikó', 'Initials': 'A', 'LastName': 'Kovács', 'Affiliation': 'Pathology, Sahlgrenska University Hospital.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Department of Oncology, Sahlgrenska Academy, University of Gothenburg per.karlsson@oncology.gu.se.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-3299']
2115,33148686,Two-year outcomes after dextrose gel prophylaxis for neonatal hypoglycaemia.,"OBJECTIVE
To determine the effect of prophylactic dextrose gel for prevention of neonatal hypoglycaemia on neurodevelopment and executive function at 2 years' corrected age.
DESIGN
Prospective follow-up of a randomised trial.
SETTING
New Zealand.
PATIENTS
Participants from the pre-hypoglycaemia Prevention with Oral Dextrose (pre-hPOD) trial randomised to one of four dose regimes of buccal 40% dextrose gel or equivolume placebo.
MAIN OUTCOME MEASURES
Coprimary outcomes were neurosensory impairment and executive function. Secondary outcomes were components of the primary outcomes, neurology, anthropometry and health measures.
RESULTS
We assessed 360 of 401 eligible children (90%) at 2 years' corrected age. There were no differences between dextrose gel dose groups, single or multiple dose groups, or any dextrose and any placebo groups in the risk of neurosensory impairment or low executive function (any dextrose vs any placebo neurosensory impairment: relative risk (RR) 0.77, 95% CI 0.50 to 1.19, p=0.23; low executive function: RR 0.50, 95% CI 0.24 to 1.06, p=0.07). There were also no differences between groups in any secondary outcomes. There was no difference between children who did or did not develop neonatal hypoglycaemia in the risk of neurosensory impairment (RR 1.05, 95% CI 0.68 to 1.64, p=0.81) or low executive function (RR 0.73, 95% CI 0.34 to 1.59, p=0.43).
CONCLUSION
Prophylactic dextrose gel did not alter neurodevelopment or executive function and had no adverse effects to 2 years' corrected age, but this study was underpowered to detect potentially clinically important effects on neurosensory outcomes.",2020,"CONCLUSION
Prophylactic dextrose gel did not alter neurodevelopment or executive function and had no adverse effects to 2 years' corrected age, but this study was underpowered to detect potentially clinically important effects on neurosensory outcomes.","['Participants from the pre-hypoglycaemia Prevention with Oral Dextrose (pre-hPOD', ""360 of 401 eligible children (90%) at 2\u2009years' corrected age"", 'New Zealand']","['buccal 40% dextrose gel or equivolume placebo', 'prophylactic dextrose gel', 'dextrose gel prophylaxis', 'placebo', 'Prophylactic dextrose gel']","['risk of neurosensory impairment or low executive function', 'neonatal hypoglycaemia', 'low executive function', 'neurodevelopment or executive function', 'neurosensory impairment and executive function', 'neonatal hypoglycaemia on neurodevelopment and executive function', 'neurology, anthropometry and health measures', 'neurosensory impairment']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0158986', 'cui_str': 'Neonatal hypoglycemia'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",401.0,0.379339,"CONCLUSION
Prophylactic dextrose gel did not alter neurodevelopment or executive function and had no adverse effects to 2 years' corrected age, but this study was underpowered to detect potentially clinically important effects on neurosensory outcomes.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Griffith', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Joanne Elizabeth', 'Initials': 'JE', 'LastName': 'Hegarty', 'Affiliation': 'Newborn Services, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Alsweiler', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Greg D', 'Initials': 'GD', 'LastName': 'Gamble', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'May', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Christopher Joel Dorman', 'Initials': 'CJD', 'LastName': 'McKinlay', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Thompson', 'Affiliation': 'Optometry and Vision Science, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Trecia Ann', 'Initials': 'TA', 'LastName': 'Wouldes', 'Affiliation': 'Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Harding', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand j.harding@auckland.ac.nz.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2020-320305']
2116,33148701,Switching between Janus kinase inhibitor upadacitinib and adalimumab following insufficient response: efficacy and safety in patients with rheumatoid arthritis.,"OBJECTIVES
To evaluate efficacy and safety of immediate switch from upadacitinib to adalimumab, or vice versa, in patients with rheumatoid arthritis with non-response or incomplete-response to the initial therapy.
METHODS
SELECT-COMPARE randomised patients to upadacitinib 15 mg once daily (n=651), placebo (n=651) or adalimumab 40 mg every other week (n=327). A treat-to-target study design was implemented, with blinded rescue occurring prior to week 26 for patients who did not achieve at least 20% improvement in both tender and swollen joint counts ('non-responders') and at week 26 based on Clinical Disease Activity Index (CDAI) >10 ('incomplete-responders') without washout.
RESULTS
A total of 39% (252/651) and 49% (159/327) of patients originally randomised to upadacitinib and adalimumab were rescued to the alternate therapy. In both switch groups (adalimumab to upadacitinib and vice versa) and in non-responders and incomplete-responders, improvements in disease activity were observed at 3 and 6 months following rescue. CDAI low disease activity was achieved by 36% and 47% of non-responders and 45% and 58% of incomplete-responders switched to adalimumab and upadacitinib, respectively, 6 months following switch. Overall, approximately 5% of rescued patients experienced worsening in disease activity at 6 months postswitch. The frequency of adverse events was similar between switch groups.
CONCLUSIONS
These observations support a treat-to-target strategy, in which patients who fail to respond initially (or do not achieve sufficient response) are switched to a therapy with an alternate mechanism of action and experience improved outcomes. No new safety findings were observed despite immediate switch without washout.",2020,"CDAI low disease activity was achieved by 36% and 47% of non-responders and 45% and 58% of incomplete-responders switched to adalimumab and upadacitinib, respectively, 6 months following switch.","['patients with rheumatoid arthritis with non-response or incomplete-response to the initial therapy', 'patients with rheumatoid arthritis']","['adalimumab', 'placebo']","['disease activity', 'CDAI low disease activity', 'Clinical Disease Activity Index (CDAI', 'frequency of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0449819,"CDAI low disease activity was achieved by 36% and 47% of non-responders and 45% and 58% of incomplete-responders switched to adalimumab and upadacitinib, respectively, 6 months following switch.","[{'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Fleischmann', 'Affiliation': 'Department of Medicine, The University of Texas Southwestern Medical Center and Metroplex Clinical Research Center, Dallas, Texas, USA rfleischmann@arthdocs.com.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Blanco', 'Affiliation': 'Division of Rheumatology, Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Department of Medicine, Monash University, Cabrini Health and Emeritus Research, Melbourne, Victoria, Australia.'}, {'ForeName': 'Glen T D', 'Initials': 'GTD', 'LastName': 'Thomson', 'Affiliation': 'CIADS Research, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Filip E', 'Initials': 'FE', 'LastName': 'Van den Bosch', 'Affiliation': 'Department of Rheumatology, University Hospital Ghent, Gent, Oost-Vlaanderen, Belgium.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Zerbini', 'Affiliation': 'Centro Paulista de Investigação Clinica, São Paulo, Brazil.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bessette', 'Affiliation': 'Université Laval Faculté de médecine, Quebec City, Québec, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Enejosa', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Yihan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Yanna', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'DeMasi', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Song', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-218412']
2117,33148720,Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial.,"INTRODUCTION
Mobility limitation is common and often results from neurological and musculoskeletal health conditions, ageing and/or physical inactivity. In consultation with consumers, clinicians and policymakers, we have developed two affordable and scalable intervention packages designed to enhance physical activity for adults with self-reported mobility limitations. Both are based on behaviour change theories and involve tailored advice from physiotherapists.
METHODS AND ANALYSIS
This pragmatic hybrid effectiveness-implementation type 1 randomised control trial (n=600) will be undertaken among adults with self-reported mobility limitations. It aims to estimate the effects on physical activity of: (1) an enhanced 6-month intervention package (one face-to-face physiotherapy assessment, tailored physical activity plan, physical activity phone coaching from a physiotherapist, informational/motivational resources and activity monitors) compared with a less intensive 6-month intervention package (single session of tailored phone advice from a physiotherapist, tailored physical activity plan, unidirectional text messages, informational/motivational resources); (2) the enhanced intervention package compared with no intervention (6-month waiting list control group); and (3) the less intensive intervention package compared with no intervention (waiting list control group). The primary outcome will be average steps per day, measured with the StepWatch Activity Monitor over a 1-week period, 6 months after randomisation. Secondary outcomes include other physical activity measures, measures of health and functioning, individualised mobility goal attainment, mental well-being, quality of life, rate of falls, health utilisation and intervention evaluation. The hybrid effectiveness-implementation design (type 1) will be used to enable the collection of secondary implementation outcomes at the same time as the primary effectiveness outcome. An economic analysis will estimate the cost-effectiveness and cost-utility of the interventions compared with no intervention and to each other.
ETHICS AND DISSEMINATION
Ethical approval has been obtained by Sydney Local Health District, Royal Prince Alfred Zone. Dissemination will be via publications, conferences, newsletters, talks and meetings with health managers.
TRIAL REGISTRATION NUMBER
ACTRN12618001983291.",2020,"In consultation with consumers, clinicians and policymakers, we have developed two affordable and scalable intervention packages designed to enhance physical activity for adults with self-reported mobility limitations.","['adults with self-reported mobility limitations', 'adults with mobility limitations']","['Physical activity coaching', 'intervention package (one face-to-face physiotherapy assessment, tailored physical activity plan, physical activity phone coaching from a physiotherapist, informational/motivational resources and activity monitors) compared with a less intensive 6-month intervention package (single session of tailored phone advice from a physiotherapist, tailored physical activity plan, unidirectional text messages, informational/motivational resources); (2) the enhanced intervention package compared with no intervention (6-month waiting list control group); and (3) the less intensive intervention package compared with no intervention (waiting list control group']","['physical activity measures, measures of health and functioning, individualised mobility goal attainment, mental well-being, quality of life, rate of falls, health utilisation and intervention evaluation', 'average steps per day, measured with the StepWatch Activity Monitor']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1565249', 'cui_str': 'Mobility Limitation'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}]",600.0,0.0882281,"In consultation with consumers, clinicians and policymakers, we have developed two affordable and scalable intervention packages designed to enhance physical activity for adults with self-reported mobility limitations.","[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hassett', 'Affiliation': 'Institute for Musculoskeletal Health, University of Sydney/ Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tiedemann', 'Affiliation': 'Institute for Musculoskeletal Health, University of Sydney/ Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Hoffmann', 'Affiliation': 'Institute for Evidence-Based Healthcare, Bond University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Harvey', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Northern Clinical School, The University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'Taylor', 'Affiliation': 'School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, New South Wales, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Greaves', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Treacy', 'Affiliation': 'Institute for Musculoskeletal Health, University of Sydney/ Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jennings', 'Affiliation': 'Liverpool Hospital, South Western Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Milat', 'Affiliation': 'School of Public Health, University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Howard', 'Affiliation': 'School of Public Health, University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Maayken', 'Initials': 'M', 'LastName': 'van den Berg', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Pinheiro', 'Affiliation': 'Institute for Musculoskeletal Health, University of Sydney/ Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Institute for Musculoskeletal Health, University of Sydney/ Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kirkham', 'Affiliation': 'Institute for Musculoskeletal Health, University of Sydney/ Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ramsay', 'Affiliation': 'Institute for Musculoskeletal Health, University of Sydney/ Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': ""O'Rourke"", 'Affiliation': 'Institute for Musculoskeletal Health, University of Sydney/ Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Institute for Musculoskeletal Health, University of Sydney/ Sydney Local Health District, Sydney, New South Wales, Australia cathie.sherrington@sydney.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-034696']
2118,33148722,"Rationale and study protocol of the Physical Activity and Dietary intervention in women with OVArian cancer (PADOVA) study: a randomised controlled trial to evaluate effectiveness of a tailored exercise and dietary intervention on body composition, physical function and fatigue in women with ovarian cancer undergoing chemotherapy.","INTRODUCTION
As a consequence of ovarian cancer and its treatment, many women with ovarian cancer have to deal with reduced physical function, fatigue, and loss of weight and/or muscle mass, compromising quality of life. Exercise and dietary interventions can positively influence body composition, physical fitness and function, and fatigue in patients with cancer. However, there are no data from randomised controlled trials on the effectiveness of exercise and dietary interventions in patients with ovarian cancer. Due to a complex disease trajectory, a relatively poor survival and distinct disease-induced and treatment-induced side effects, it is unclear whether exercise and dietary interventions that were shown to be feasible and effective in other types of cancer produce comparable results in patients with ovarian cancer. The aim of this article is to present the design of the multicentre randomised controlled Physical Activity and Dietary intervention in OVArian cancer trial and to describe how the exercise and dietary intervention is tailored to specific comorbidities and disease-induced and treatment-induced adverse effects in patients with ovarian cancer.
METHODS AND ANALYSIS
Adult women with primary epithelial ovarian cancer who are scheduled to undergo first-line (neo)adjuvant chemotherapy (n=122) are randomly allocated to a combined exercise and dietary intervention or a usual care control group during chemotherapy. Primary outcomes are body composition, physical function and fatigue. Outcome measures will be assessed before the start of chemotherapy, 3 weeks after completion of chemotherapy and 12 weeks later. The exercise and dietary intervention was tailored to ovarian cancer-specific comorbidities and adverse effects of ovarian cancer and its treatment following the i3-S strategy.
ETHICS AND DISSEMINATION
This study has been approved by the medical ethical committee of the Amsterdam UMC (reference: 018). Results of the study will be published in international peer-reviewed journals.
TRIAL REGISTRATION NUMBER
Netherlands Trial Registry (NTR6300).",2020,(neo)adjuvant chemotherapy (n=122) are randomly allocated to a combined exercise and dietary intervention or a usual care control group during chemotherapy.,"['Adult women with primary epithelial ovarian cancer who are scheduled to undergo first-line', 'neo)adjuvant chemotherapy (n=122', 'patients with ovarian cancer', 'women with OVArian cancer (PADOVA) study', 'women with ovarian cancer', 'women with ovarian cancer undergoing chemotherapy', 'patients with cancer']","['Exercise and dietary interventions', 'exercise and dietary interventions', 'combined exercise and dietary intervention or a usual care control group during chemotherapy', 'tailored exercise and dietary intervention', 'exercise and dietary intervention', 'Physical Activity and Dietary intervention', 'Dietary intervention']","['body composition, physical function and fatigue', 'body composition, physical fitness and function, and fatigue']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",,0.126033,(neo)adjuvant chemotherapy (n=122) are randomly allocated to a combined exercise and dietary intervention or a usual care control group during chemotherapy.,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Stelten', 'Affiliation': 'Epidemiology and Biostatistics, Amsterdam Public Health research institute, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Meeke', 'Initials': 'M', 'LastName': 'Hoedjes', 'Affiliation': 'Medical and Clinical Psychology, Center of Research on Psychology in Somatic diseases, Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'Gemma G', 'Initials': 'GG', 'LastName': 'Kenter', 'Affiliation': 'Obstetrics and Gynaecology, Cancer Center Amsterdam, Center for Gynaecologic Oncology Amsterdam (CGOA), Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Kampman', 'Affiliation': 'Human Nutrition and Health, Wageningen University and Research, Wageningen, The Netherlands.'}, {'ForeName': 'Rosalie J', 'Initials': 'RJ', 'LastName': 'Huijsmans', 'Affiliation': 'Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit van Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Luc Rcw', 'Initials': 'LR', 'LastName': 'van Lonkhuijzen', 'Affiliation': 'Obstetrics and Gynaecology, Amsterdam UMC, Univ(ersity) of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Buffart', 'Affiliation': 'Epidemiology and Biostatistics, Amsterdam Public Health research institute, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands laurien.buffart@radboudumc.nl.'}]",BMJ open,['10.1136/bmjopen-2020-036854']
2119,33148725,Effect of a financial incentive (shopping point) on increasing the number of daily walking steps among community-dwelling adults in Japan: a randomised controlled trial.,"OBJECTIVE
The aim of this study was to investigate the effect of a financial incentive on the number of daily walking steps among community-dwelling adults in Japan.
STUDY DESIGN
Two-arm, parallel-group randomised controlled trial.
SETTING/PARTICIPANTS
We recruited physically inactive community-dwelling adults from Sendai city, Japan. Eligible participants were randomly allocated to an intervention or a wait list control group. Pedometers were used to assess the mean number of daily steps in three periods: baseline (weeks 1-3), intervention (weeks 4-6) and follow-up (weeks 7-9).
INTERVENTION
The intervention group was offered a financial incentive (shopping points) to meet the target number of increased daily steps in the intervention period.
MAIN OUTCOME MEASURES
The primary outcome was an increase in the mean number of daily steps in the intervention and follow-up periods compared with baseline.
RESULTS
Seventy-two participants (69.4% women; mean age, 61.2±16.2 years; mean number of daily steps at baseline, 6364±2804) were randomised to the intervention (n=36) and control groups (n=36). During the intervention period, the increase in mean daily steps was significantly higher in the intervention group (1650, 95% CI=1182 to 2119) than in the control group (514, 95% CI=136 to 891; p<0.001). However, the difference between groups was not significant at follow-up after the incentives were removed (p=0.311). In addition, compared with controls, a significantly higher proportion of participants in the intervention group showed an increase in mean daily steps of ≥1000 (69.4% vs 30.6%, respectively; OR=5.17, 95% CI=1.89 to 14.08). There were no adverse effects from the intervention.
CONCLUSIONS
The present results suggest that financial incentives are effective in promoting short-term increases in physical activity.
TRIAL REGISTRATION NUMBER
UMIN000033276.",2020,"The primary outcome was an increase in the mean number of daily steps in the intervention and follow-up periods compared with baseline.
","['Eligible participants', 'physically inactive community-dwelling adults from Sendai city, Japan', 'community-dwelling adults in Japan', 'Seventy-two participants (69.4% women; mean age, 61.2±16.2 years; mean number of daily steps at baseline, 6364±2804']","['intervention or a wait list control group', 'financial incentive (shopping points', 'financial incentive', 'financial incentive (shopping point']","['mean daily steps', 'adverse effects', 'mean number of daily steps', 'number of daily walking steps']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.196357,"The primary outcome was an increase in the mean number of daily steps in the intervention and follow-up periods compared with baseline.
","[{'ForeName': 'Fumiya', 'Initials': 'F', 'LastName': 'Tanji', 'Affiliation': 'Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Yasutake', 'Initials': 'Y', 'LastName': 'Tomata', 'Affiliation': 'Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Saho', 'Initials': 'S', 'LastName': 'Abe', 'Affiliation': 'Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Sanae', 'Initials': 'S', 'LastName': 'Matsuyama', 'Affiliation': 'Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Yumika', 'Initials': 'Y', 'LastName': 'Kotaki', 'Affiliation': 'Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Dieta', 'Initials': 'D', 'LastName': 'Nurrika', 'Affiliation': 'Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Yingxu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Yukai', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Sugawara', 'Affiliation': 'Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Shino', 'Initials': 'S', 'LastName': 'Bando', 'Affiliation': 'Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Teiichiro', 'Initials': 'T', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Tatsui', 'Initials': 'T', 'LastName': 'Otsuka', 'Affiliation': 'Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Toshimasa', 'Initials': 'T', 'LastName': 'Sone', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Science, Tohoku Fukushi University, Sendai, Miyagi, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Tsuji', 'Affiliation': 'Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan tsuji1@med.tohoku.ac.jp.'}]",BMJ open,['10.1136/bmjopen-2020-037303']
2120,33148737,Effects of exergames training on postural balance in patients who had a chronic stroke: study protocol for a randomised controlled trial.,"INTRODUCTION
Exergames training, as an additional therapy to standard care, has been widely used for motor recovery after patients who had a stroke, and it is a valuable and positive tool in the rehabilitation of this population. This study describes a single-blind randomised clinical trial that will aim to investigate the effects of exergames training on postural balance in patients with chronic stroke.
METHODS AND ANALYSIS
Forty-two individuals with chronic stroke (>6 months), aged 20-75 years, will be randomised into two groups: the experimental group, which will be subjected to an exergames protocol, and control group, which will undergo a kinesiotherapy protocol. Both protocols are based on postural balance. The intervention will consist of 40-minute sessions two times per week for 10 consecutive weeks. The volunteers will be evaluated before the treatment, at the end of the interventions and 8 weeks thereafter. The primary outcome will be postural balance (Berg Balance Scale, Functional Reach Test, Timed Up and Go test and Centre of Pressure variables) and secondary outcomes will include gait (6 m timed walk and Kinovea Software), cortical activation patterns (electroencephalography Emotiv EPOC), functional independence (Functional Independence Measure), quality of life (Stroke-Specific Quality of Life Scale) and motivation (Intrinsic Motivation Inventory).
ETHICS AND DISSEMINATION
This protocol was approved by the Ethics Committee of the Federal University of Rio Grande do Norte (number 3.434.350). The results of the study will be disseminated to participants through social networks and will be submitted to a peer-reviewed journal and scientific meetings.
TRIAL REGISTRATION NUMBER
Brazilian Registry of Clinical Trials (RBR-78v9hx).",2020,"The primary outcome will be postural balance (Berg Balance Scale, Functional Reach Test,","['Forty-two individuals with chronic stroke (>6 months), aged 20-75 years', 'patients with chronic stroke', 'patients who had a chronic stroke']",['exergames training'],"['gait (6\u2009m timed walk and Kinovea Software), cortical activation patterns (electroencephalography Emotiv EPOC), functional independence (Functional Independence Measure), quality of life (Stroke-Specific Quality of Life Scale) and motivation (Intrinsic Motivation Inventory', 'postural balance (Berg Balance Scale, Functional Reach Test', 'postural balance']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0280558', 'cui_str': 'COPE regimen'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1256755', 'cui_str': 'Postural balance'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}]",42.0,0.0951125,"The primary outcome will be postural balance (Berg Balance Scale, Functional Reach Test,","[{'ForeName': 'Nathalia Priscilla Oliveira Silva', 'Initials': 'NPOS', 'LastName': 'Bessa', 'Affiliation': 'Departament of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil nathyzinhasilva@gmail.com.'}, {'ForeName': 'Bartolomeu Fagundes de', 'Initials': 'BF', 'LastName': 'Lima Filho', 'Affiliation': 'Departament of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Candice Simões Pimenta de', 'Initials': 'CSP', 'LastName': 'Medeiros', 'Affiliation': 'Departament of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Tatiana Souza', 'Initials': 'TS', 'LastName': 'Ribeiro', 'Affiliation': 'Departament of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Tânia Fernandes', 'Initials': 'TF', 'LastName': 'Campos', 'Affiliation': 'Departament of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Fabrícia Azevêdo da Costa', 'Initials': 'FADC', 'LastName': 'Cavalcanti', 'Affiliation': 'Departament of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.'}]",BMJ open,['10.1136/bmjopen-2020-038593']
2121,33148764,"Tranexamic ACid during PancereaticoDuodenectomy (TAC-PD): study protocol for a multicentre randomised, blind, placebo-controlled trial.","INTRODUCTION
Pancreaticoduodenectomy (PD) is a major gastroenterological surgery that results in a substantial amount of blood loss. Several studies have demonstrated that major blood loss during PD is associated with both short-term and long-term poor outcomes. Administration of perioperative tranexamic acid (TXA) has been reported to reduce intraoperative blood loss in various surgeries, including cardiovascular surgery and orthopaedic surgery. Nevertheless, the effect of perioperative TXA use in patients undergoing PD has not been investigated. This study aims to investigate the effect of TXA on blood loss during PD.
METHODS AND ANALYSIS
A multicentre (six hospitals), randomised, blind (patient-blinded, surgeon-blinded, anaesthesiologist-blinded, monitor-blinded), placebo-controlled trial of TXA during PD was started in September 2019. Patients undergoing PD for biliary, duodenal or pancreatic diseases are randomly assigned to the TXA or placebo group. The stratification factors are the institutions and preoperative clinical diagnosis. Before skin incision, the participants in TXA group are administrated 1 g TXA as a loading infusion followed by a maintenance infusion of 125 mg/hour TXA until the end of surgery or 8 hours from the incision. Participants in the placebo group are administrated the same volume of saline that is indistinguishable from the TXA. The primary outcome is blood loss during PD. The secondary outcomes are intraoperative and postoperative (up to day 2) blood transfusions, operation time, anaesthesia time, postoperative laboratory variables, length of hospital stay, in-hospital and 90-day mortality and postoperative complications occurring within 28 days of surgery or requiring readmission. To date, 115 patients of a planned 220 have been enrolled in the study.
ETHICS AND DISSEMINATION
This protocol was approved by the Nagoya University Clinical Research Review Board and is registered with Japan Registry of Clinical Trials on 15 August 2019. The results of this trial will be disseminated through peer-reviewed journals.
TRIAL REGISTRATION NUMBER
jRCTs041190062.",2020,"Administration of perioperative tranexamic acid (TXA) has been reported to reduce intraoperative blood loss in various surgeries, including cardiovascular surgery and orthopaedic surgery.","['115 patients of a planned 220 have been enrolled in the study', 'patients undergoing PD', 'Patients undergoing PD for biliary, duodenal or pancreatic diseases']","['TXA or placebo', 'Tranexamic ACid during PancereaticoDuodenectomy (TAC-PD', 'placebo', 'perioperative tranexamic acid (TXA', 'TXA', 'Pancreaticoduodenectomy (PD']","['blood loss during PD', 'intraoperative and postoperative (up to day 2) blood transfusions, operation time, anaesthesia time, postoperative laboratory variables, length of hospital stay, in-hospital and 90-day mortality and postoperative complications occurring within 28 days of surgery or requiring readmission', 'blood loss']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0030286', 'cui_str': 'Disorder of pancreas'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}]",,0.672287,"Administration of perioperative tranexamic acid (TXA) has been reported to reduce intraoperative blood loss in various surgeries, including cardiovascular surgery and orthopaedic surgery.","[{'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Ishii', 'Affiliation': 'Surgical Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan ishiikenta0701@gmail.com.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Yokoyama', 'Affiliation': 'Surgical Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Yonekawa', 'Affiliation': 'Surgical Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Ebata', 'Affiliation': 'Surgical Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}]",BMJ open,['10.1136/bmjopen-2020-040914']
2122,33148945,β-hydroxy-β-methylbutyrate supplementation in older persons - an update.,"PURPOSE OF REVIEW
The interest in the use of beta-hydroxy-beta-methylbutyrate (HMB) as an intervention to prevent and treat sarcopenia has increased over recent years. The purpose of this review is to explore recent evidence pertaining to the mechanism of action of HMB and how this may influence changes in lean mass and strength in older persons who are both hospitalized and living in the community.
RECENT FINDINGS
No new studies have been published over the last 2 years investigating the effect of HMB in older persons who are hospitalized, aside from one posthoc analysis of a randomized controlled trial exploring the effect of a high protein oral nutrition supplement containing HMB on handgrip strength and nutritional status. Three studies recruiting community-dwelling older adults have been published, but results are influenced by suboptimal methodological quality.
SUMMARY
Recent data suggest the need for high-quality studies investigating the effectiveness of HMB to improve outcomes related to sarcopenia in both hospitalized and community-dwelling older persons.",2020,"No new studies have been published over the last 2 years investigating the effect of HMB in older persons who are hospitalized, aside from one posthoc analysis of a randomized controlled trial exploring the effect of a high protein oral nutrition supplement containing HMB on handgrip strength and nutritional status.","['older persons - an update', 'older persons who are hospitalized', 'older persons who are both hospitalized and living in the community']","['beta-hydroxy-beta-methylbutyrate (HMB', 'HMB', 'β-hydroxy-β-methylbutyrate supplementation']",[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0053454', 'cui_str': '3-hydroxyisovaleric acid'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]",[],,0.0381543,"No new studies have been published over the last 2 years investigating the effect of HMB in older persons who are hospitalized, aside from one posthoc analysis of a randomized controlled trial exploring the effect of a high protein oral nutrition supplement containing HMB on handgrip strength and nutritional status.","[{'ForeName': 'Daniele E', 'Initials': 'DE', 'LastName': 'Bear', 'Affiliation': ""Departments of Nutrition and Dietetics and Critical Care, Guy's and St Thomas' NHS Foundation Trust.""}, {'ForeName': 'Alfonso J', 'Initials': 'AJ', 'LastName': 'Cruz-Jentoft', 'Affiliation': 'Servicio de Geriatría, Hospital Universitario Ramón y Cajal (IRYCIS), Madrid, Spain.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Stout', 'Affiliation': 'Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, Orlando, Florida, USA.'}]",Current opinion in clinical nutrition and metabolic care,['10.1097/MCO.0000000000000713']
2123,33148955,The Optimal Dosing Regimen for Tranexamic Acid in Revision Total Hip Arthroplasty: A Multicenter Randomized Clinical Trial.,"BACKGROUND
The purpose of this multicenter, randomized trial was to determine the optimal dosing regimen of tranexamic acid (TXA) to minimize perioperative blood loss in revision total hip arthroplasty.
METHODS
Six centers prospectively randomized 175 patients to 1 of 4 regimens: (1) 1-g intravenous (IV) TXA prior to incision (the single-dose IV group), (2) 1-g IV TXA prior to incision followed by 1-g IV TXA after arthrotomy wound closure (the double-dose IV group), (3) a combination of 1-g IV TXA prior to incision and 1-g intraoperative topical TXA (the combined IV and topical group), or (4) 3 doses totaling 1,950-mg oral TXA (the multidose oral group). Randomization was based on revision subgroups to ensure equivalent group distribution. An a priori power analysis (α = 0.05; β = 0.80) determined that 40 patients per group were required to identify a >1-g/dL difference in postoperative hemoglobin reduction between groups. Per-protocol analysis involved an analysis of variance, Fisher exact tests, and two 1-sided t tests for equivalence. Demographic and surgical variables were equivalent between groups.
RESULTS
No significant differences were found between TXA regimens when evaluating reduction in hemoglobin (3.4 g/dL for the single-dose IV group, 3.6 g/dL for the double-dose IV group, 3.5 g/dL for the combined IV and topical group, and 3.4 g/dL for the multidose oral group; p = 0.95), calculated blood loss (p = 0.90), or transfusion rates (14% for the single-dose IV group, 18% for the double-dose IV group, 17% for the combined group, and 17% for the multidose oral group; p = 0.96). Equivalence testing revealed that all possible pairings were statistically equivalent, assuming a >1-g/dL difference in hemoglobin reduction as clinically relevant. There was 1 venous thromboembolism, with no differences found between groups (p = 1.00).
CONCLUSIONS
All 4 TXA groups tested had equivalent blood-sparing properties in the setting of revision total hip arthroplasty, with a single venous thromboembolism reported in this high-risk population. Based on the equivalence between groups, surgeons should utilize whichever of the 4 investigated regimens is best suited for their practice and hospital setting. Given the transfusion rate in revision total hip arthroplasty despite TXA utilization, further work is required in this area.
LEVEL OF EVIDENCE
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"No significant differences were found between TXA regimens when evaluating reduction in hemoglobin (3.4 g/dL for the single-dose IV group, 3.6 g/dL for the double-dose IV group, 3.5 g/dL for the combined IV and topical group, and 3.4 g/dL for the multidose oral group; p = 0.95), calculated blood loss (p = 0.90), or transfusion rates (14% for the single-dose IV group, 18% for the double-dose IV group, 17% for the combined group, and 17% for the multidose oral group; p = 0.96).","['revision total hip arthroplasty', 'Revision Total Hip Arthroplasty', 'Six centers prospectively randomized 175 patients to 1 of 4 regimens: (1']","['TXA prior to incision followed by 1-g IV TXA', 'Tranexamic Acid', 'tranexamic acid (TXA', 'TXA prior to incision and 1-g intraoperative topical TXA', 'TXA', '1-g intravenous (IV) TXA']","['postoperative hemoglobin reduction', 'calculated blood loss', 'transfusion rates', 'hemoglobin reduction', 'venous thromboembolism', 'hemoglobin']","[{'cui': 'C0186202', 'cui_str': 'Revision of total hip replacement'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",175.0,0.117843,"No significant differences were found between TXA regimens when evaluating reduction in hemoglobin (3.4 g/dL for the single-dose IV group, 3.6 g/dL for the double-dose IV group, 3.5 g/dL for the combined IV and topical group, and 3.4 g/dL for the multidose oral group; p = 0.95), calculated blood loss (p = 0.90), or transfusion rates (14% for the single-dose IV group, 18% for the double-dose IV group, 17% for the combined group, and 17% for the multidose oral group; p = 0.96).","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Sershon', 'Affiliation': 'Department of Orthopedic Surgery, Anderson Orthopaedic Research Institute, Alexandria, Virginia.'}, {'ForeName': 'Yale A', 'Initials': 'YA', 'LastName': 'Fillingham', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Abdel', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Arthur L', 'Initials': 'AL', 'LastName': 'Malkani', 'Affiliation': 'Department of Orthopedic Surgery, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Schwarzkopf', 'Affiliation': 'Department of Orthopedic Surgery, New York University, New York, NY.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Padgett', 'Affiliation': 'Department of Orthopedic Surgery, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Vail', 'Affiliation': 'Department of Orthopedic Surgery, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Nam', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Nahhas', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Culvern', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Della Valle', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00010']
2124,33148972,Kinetics of Muscle Carnosine Decay after β-alanine Supplementation: A 16-Week Washout Study.,"PURPOSE
To describe the kinetics of carnosine washout in human skeletal muscle over 16 weeks.
METHODS
Carnosine washout kinetics were studied in fifteen young, physically-active omnivorous men randomly assigned to take 6.4 g·d of β-alanine (n=11) or placebo (PL, n=4) for 8 weeks. Muscle carnosine content (M-Carn) was determined before (PRE), immediately after (POST) and 4, 8, 12 and 16 weeks after supplementation. High-intensity exercise tests were performed at these same time points. Linear and exponential models were fitted to the washout data and the leave-one-out method was used to select the model with the best fit for M-Carn decay data. Repeated measures correlation analysis was used to assess the association between changes in M-Carn and changes in performance.
RESULTS
M-Carn increased from PRE to POST in the β-alanine group only (+91.1±29.1%; PL:+0.04±10.1%; p<0.0001). M-Carn started to decrease after cessation of β-alanine supplementation and continued to decrease until week 16 (POST4:+59±40%; POST8:+35±39%; POST12:+18±32%; POST16:-3±24% of PRE M-Carn). From week 12 onwards, M-Carn was no longer statistically different from PRE. Both linear and exponential models displayed very similar fit and could be used to describe carnosine washout, although the linear model presented a slightly better fit. The decay in M-Carn was mirrored by a similar decay in high-intensity exercise tolerance; M-Carn was moderately and significantly correlated with TWD (r=0.505; p=0.032) and TTE (r=0.72; p<0.001).
CONCLUSION
Carnosine washout takes 12-16 weeks to complete, and it can be described either by linear or exponential curves. Changes in M-Carn appear to be mirrored by changes in high-intensity exercise tolerance. This information can be used to optimise β-alanine supplementation strategies.",2020,"From week 12 onwards, M-Carn was no longer statistically different from PRE.","['fifteen young, physically-active omnivorous men randomly assigned to take 6.4 g·d of']","['placebo', 'β-alanine Supplementation', 'β-alanine']","['decay in M-Carn', 'M-Carn increased from PRE to POST', 'Muscle carnosine content (M-Carn']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517822', 'cui_str': '6.4'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0007267', 'cui_str': 'Carnosine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",15.0,0.0251349,"From week 12 onwards, M-Carn was no longer statistically different from PRE.","[{'ForeName': 'Guilherme Carvalho', 'Initials': 'GC', 'LastName': 'Yamaguchi', 'Affiliation': 'Applied Physiology & Nutrition Research Group School of Physical Education and Sport. Rheumatology Division.'}, {'ForeName': 'Kleiner', 'Initials': 'K', 'LastName': 'Nemezio', 'Affiliation': 'Applied Physiology & Nutrition Research Group School of Physical Education and Sport. Rheumatology Division.'}, {'ForeName': 'Mariane Leichsenring', 'Initials': 'ML', 'LastName': 'Schulz', 'Affiliation': 'Departamento de Bioquímica, Instituto de Química, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Natali', 'Affiliation': 'Applied Physiology & Nutrition Research Group School of Physical Education and Sport. Rheumatology Division.'}, {'ForeName': 'Jonatas Eduardo', 'Initials': 'JE', 'LastName': 'Cesar', 'Affiliation': 'Departamento de Genética e Biologia Evolutiva, Instituto de Biociências, Universidade de São Paulo, SP, Brazil.'}, {'ForeName': 'Luiz Augusto', 'Initials': 'LA', 'LastName': 'Riani', 'Affiliation': 'Applied Physiology & Nutrition Research Group School of Physical Education and Sport. Rheumatology Division.'}, {'ForeName': 'Lívia', 'Initials': 'L', 'LastName': 'de Souza Gonçalves', 'Affiliation': 'Applied Physiology & Nutrition Research Group School of Physical Education and Sport. Rheumatology Division.'}, {'ForeName': 'Gabriella Berwig', 'Initials': 'GB', 'LastName': 'Möller', 'Affiliation': 'Applied Physiology & Nutrition Research Group School of Physical Education and Sport. Rheumatology Division.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Sale', 'Affiliation': 'Musculoskeletal Physiology Research Group, Sport, Health and Performance Enhancement Research Centre, Nottingham Trent University, United Kingdom.'}, {'ForeName': 'Marisa Helena Gennari', 'Initials': 'MHG', 'LastName': 'de Medeiros', 'Affiliation': 'Departamento de Bioquímica, Instituto de Química, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology & Nutrition Research Group School of Physical Education and Sport. Rheumatology Division.'}, {'ForeName': 'Guilherme Giannini', 'Initials': 'GG', 'LastName': 'Artioli', 'Affiliation': 'Applied Physiology & Nutrition Research Group School of Physical Education and Sport. Rheumatology Division.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002559']
2125,33148981,Antibiotic Prophylaxis for Percutaneous Endoscopic Gastrostomy in Children: A Randomised Controlled Trial.,"OBJECTIVES
Paediatric studies on the role of antibiotic prophylaxis in the prevention of postoperative infections in children undergoing percutaneous endoscopic gastrostomy (PEG) are lacking. The aim of this study was to assess if a single dose of co-amoxiclav before PEG can decrease the rate of peristomal wound and systemic infection in children.
METHODS
In this prospective, randomised, double blind, multicenter trial, children undergoing PEG were randomized to antibiotic prophylaxis with co-amoxiclav versus placebo and the rate of local and systemic infections were assessed.
RESULTS
Of the 106 patients considered for inclusion, 49 patients were randomized. In the per protocol analysis, the occurrence of wound infection was 5% (1/20) in the antibiotic group and 21% (4/19) in the placebo group [p = 0.13, 16% difference in proportions, OR 0.19, 95% CI 0.02-1.9]. The occurrence of systemic infection was 9% (2/22) in the antibiotic group and 27.2% (6/25) in the placebo group [p = 0.17, 18% difference in proportions, OR 0.32, 95% CI 0.06-1.80%]. Similar results were obtained in intention to treat analysis. Interestingly, the overall infection rate was significantly higher in the placebo group as compared to the antibiotic group (40% vs 13,6%; p = 0.04) and the duration of hospital stay was significantly longer in the placebo group as compared to the antibiotic group (4.4 ± 1.6 vs 3.5 ± 1.05; p = 0.02). The number-needed-to-treat (NTT) to prevent one peristomal infection on average are 6.7 patients.
CONCLUSIONS
A preoperative dose of co-amoxiclav reduces the overall infection rate and the duration of hospital stay. Our data suggest that antibiotic prophylaxis should be recommended in every children undergoing PEG placement.",2020,"In the per protocol analysis, the occurrence of wound infection was 5% (1/20) in the antibiotic group and 21% (4/19) in the placebo group [","['children undergoing PEG', 'children undergoing percutaneous endoscopic gastrostomy (PEG', 'children', 'every children undergoing PEG placement', 'Children', '106 patients considered for inclusion, 49 patients were randomized']","['co-amoxiclav before PEG', 'Antibiotic Prophylaxis', 'Percutaneous Endoscopic Gastrostomy', 'placebo', 'antibiotic prophylaxis with co-amoxiclav versus placebo', 'antibiotic prophylaxis']","['overall infection rate and the duration of hospital stay', 'occurrence of systemic infection', 'occurrence of wound infection', 'duration of hospital stay', 'overall infection rate', 'rate of peristomal wound and systemic infection']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0176751', 'cui_str': 'Percutaneous endoscopic gastrostomy'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}, {'cui': 'C0176751', 'cui_str': 'Percutaneous endoscopic gastrostomy'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]",106.0,0.701128,"In the per protocol analysis, the occurrence of wound infection was 5% (1/20) in the antibiotic group and 21% (4/19) in the placebo group [","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Alessandri', 'Affiliation': 'Department of General and Specialistic Surgery ""Paride Stefanini"", ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Strisciuglio', 'Affiliation': 'Department of Woman, Child and General and Specialistic Surgery, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Borrazzo', 'Affiliation': 'Department of Public Health and Infectious Diseases, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Cozzi', 'Affiliation': 'Pediatric Surgery Unit, Sapienza University of Rome, Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Romano', 'Affiliation': 'Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood ""G. Barresi"", University of Messina, Messina, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Betalli', 'Affiliation': 'Pediatric Surgery Unit, Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Villa', 'Affiliation': ""NESMOS Department, Chair of Pediatrics, Sapienza University of Rome, Sant'Andrea University Hospital, Rome, Italy.""}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Parisi', 'Affiliation': ""NESMOS Department, Chair of Pediatrics, Sapienza University of Rome, Sant'Andrea University Hospital, Rome, Italy.""}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Ziparo', 'Affiliation': ""NESMOS Department, Chair of Pediatrics, Sapienza University of Rome, Sant'Andrea University Hospital, Rome, Italy.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Rocco', 'Affiliation': ""Department of Clinical and Surgical Translational Medicine, Anesthesia and Intensive Care Medicine, Sant'Andrea University Hospital, Sapienza University of Rome, Rome, Italy.""}, {'ForeName': 'Melania', 'Initials': 'M', 'LastName': 'Evangelisti', 'Affiliation': ""NESMOS Department, Chair of Pediatrics, Sapienza University of Rome, Sant'Andrea University Hospital, Rome, Italy.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pugliese', 'Affiliation': 'Department of General and Specialistic Surgery ""Paride Stefanini"", ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Di Nardo', 'Affiliation': ""NESMOS Department, Chair of Pediatrics, Sapienza University of Rome, Sant'Andrea University Hospital, Rome, Italy.""}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002981']
2126,33149136,"Anti-bacterial antibodies in multiple myeloma patients at disease presentation, in response to therapy and in remission: implications for patient management.","Multiple myeloma (MM) is associated with increased risk of infection, but little is known regarding antibody levels against specific bacteria. We assessed levels of polyclonal immunoglobulin and antibacterial antibodies in patients recruited to the TEAMM trial, a randomised trial of antibiotic prophylaxis at the start of anti-myeloma treatment. Polyclonal IgG, IgA and IgM levels were below the reference range in 71%, 83% and 90% of 838 MM patients at diagnosis. Anti-vaccine targeted tetanus toxoid antibodies were protective in 95% of 193 healthy controls but only 41% of myeloma patients. In healthy controls, protective antibodies against 6/12 pneumococcal serotypes, haemophilus and meningococcus A were present in 67%, 41% and 56% compared to just 15%, 21% and 17% of myeloma patients. By 1 year, myeloma patients IgG levels had recovered for 57% of patients whilst the proportion with protective levels of IgG against thymus-dependent protein antigen tetanus toxoid had changed little. In contrast the proportions of patients with protective levels against thymus independent polysaccharide antigens pneumococcus, haemophilus and meningococcus had fallen from 15 to 7%, 21 to 0% and 17 to 11%. Findings highlight the need for strategies to protect patients against bacterial infections during therapy and vaccination programmes during remission.",2020,"Polyclonal IgG, IgA and IgM levels were below the reference range in 71%, 83% and 90% of 838 MM patients at diagnosis.","['multiple myeloma patients', '193 healthy controls but only 41% of myeloma patients', 'patients recruited to the TEAMM trial']",['antibiotic prophylaxis'],"['Polyclonal IgG, IgA and IgM levels', 'polyclonal immunoglobulin and antibacterial antibodies']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]","[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0003244', 'cui_str': 'Anti bacterial antibody'}]",,0.0252044,"Polyclonal IgG, IgA and IgM levels were below the reference range in 71%, 83% and 90% of 838 MM patients at diagnosis.","[{'ForeName': 'Ilaria J', 'Initials': 'IJ', 'LastName': 'Chicca', 'Affiliation': 'Institute of Immunology and Immunotherapy, Clinical Immunology Service, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jennifer L J', 'Initials': 'JLJ', 'LastName': 'Heaney', 'Affiliation': 'Institute of Immunology and Immunotherapy, Clinical Immunology Service, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Gulnaz', 'Initials': 'G', 'LastName': 'Iqbal', 'Affiliation': 'Warwick Clinical Trial Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Dunn', 'Affiliation': 'Warwick Clinical Trial Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Bowcock', 'Affiliation': ""King's College Hospital NHS Trust, London, UK.""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Pratt', 'Affiliation': 'University Hospital Birmingham NHS Trust, Birmingham, UK.'}, {'ForeName': 'Kwee L', 'Initials': 'KL', 'LastName': 'Yong', 'Affiliation': 'Department of Haematology, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Planche', 'Affiliation': ""St. George's Hospital, University of London, Department of Medical Microbiology, Tooting, London, UK.""}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Richter', 'Affiliation': 'Institute of Immunology and Immunotherapy, Clinical Immunology Service, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Drayson', 'Affiliation': 'Institute of Immunology and Immunotherapy, Clinical Immunology Service, University of Birmingham, Birmingham, UK. M.T.Drayson@bham.ac.uk.'}]",Blood cancer journal,['10.1038/s41408-020-00370-7']
2127,33149205,Effect of anthelmintic treatment on serum free IGF-1 and IGFBP-3: a cluster-randomized-controlled trial in Indonesia.,"In children, soil-transmitted helminth infections have been linked to poor nutritional status and growth retardation in association with lower levels of IGF-1. In adults, IGF-1 has an anabolic and metabolic function and is related to nutritional status. Here, we assessed the impact of helminth infection on free IGF-1 and its major binding protein, IGFBP-3, in adults. The levels of IGF-1 and IGFBP3 were measured in 1669 subjects aged ≥ 16 years, before and after receiving four rounds of albendazole 400 mg/day or matching placebo for three consecutive days. Helminth infection status was assessed by microscopy (Kato-Katz) and PCR. Serum free IGF-1 level was significantly lower in helminth-infected subjects [mean difference and 95% CI - 0.068 (- 0.103; - 0.033), P < 0.001 after adjustment for age, sex, body mass index, and fasting insulin level]. There was no difference in IGFBP-3 level between helminth infected versus non-infected subjects. In the whole study population, albendazole treatment significantly increased serum free IGF-1 level [estimate and 95% CI 0.031 (0.004; - 0.057), P = 0.024] whereas no effect was found on the IGFBP-3 level. Our study showed that helminth infection in adults is associated with lower free IGF-1 levels but not with IGFBP-3 and albendazole treatment significantly increases free IGF-1 levels in the study population.Clinical Trial Registration: https://www.isrctn.com/ISRCTN75636394 .",2020,Serum free IGF-1 level was significantly lower in helminth-infected subjects [,"['adults', '1669 subjects aged\u2009≥']","['anthelmintic treatment', 'albendazole', 'albendazole 400\xa0mg/day or matching placebo']","['serum free IGF-1 and IGFBP-3', 'IGFBP-3 level', 'Helminth infection status', 'Serum free IGF-1 level', 'serum free IGF-1 level', 'levels of IGF-1', 'free IGF-1 levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0003158', 'cui_str': 'Anthelmintic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018889', 'cui_str': 'Helminth infection'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",1669.0,0.0812596,Serum free IGF-1 level was significantly lower in helminth-infected subjects [,"[{'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Kurniawan', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Cipto Mangunkusumo National General Hospital/Faculty of Medicine Universitas Indonesia, Jl. Diponegoro No. 71, Jakarta Pusat, DKI Jakarta, 10430, Indonesia.'}, {'ForeName': 'Dicky L', 'Initials': 'DL', 'LastName': 'Tahapary', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Cipto Mangunkusumo National General Hospital/Faculty of Medicine Universitas Indonesia, Jl. Diponegoro No. 71, Jakarta Pusat, DKI Jakarta, 10430, Indonesia. dicky.tahapary@ui.ac.id.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'de Ruiter', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Em', 'Initials': 'E', 'LastName': 'Yunir', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Cipto Mangunkusumo National General Hospital/Faculty of Medicine Universitas Indonesia, Jl. Diponegoro No. 71, Jakarta Pusat, DKI Jakarta, 10430, Indonesia.'}, {'ForeName': 'Nienke R', 'Initials': 'NR', 'LastName': 'Biermasz', 'Affiliation': 'Department of Endocrinology and Metabolic Disease, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Johannes W A', 'Initials': 'JWA', 'LastName': 'Smit', 'Affiliation': 'Department of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Taniawati', 'Initials': 'T', 'LastName': 'Supali', 'Affiliation': 'Department of Parasitology, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Erliyani', 'Initials': 'E', 'LastName': 'Sartono', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Yazdanbakhsh', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Pradana', 'Initials': 'P', 'LastName': 'Soewondo', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Cipto Mangunkusumo National General Hospital/Faculty of Medicine Universitas Indonesia, Jl. Diponegoro No. 71, Jakarta Pusat, DKI Jakarta, 10430, Indonesia.'}]",Scientific reports,['10.1038/s41598-020-75781-4']
2128,33149375,The Educare intervention: Outcomes at age 3.,"The effectiveness of Educare, a center-based early education program, in improving child outcomes at age 3 was evaluated in a randomized clinical trial. Educare programs serve children from birth to age 5 and are designed to reduce the achievement gap between children from low-income families and their more advantaged peers. This study began following 239 children from low-income families who were randomly assigned as infants (<19 months) to Educare or a business-as-usual control group. At age 3, assessments of the skills of 202 children remaining in the study revealed significant differences in favor of children in the treatment group on auditory language skills, early math skills, and parent-reported problem behaviors. Effect sizes were in the modest range, although not as strong as the previously reported age 2 findings. No effects were found for observations of parent-child interactions, observer-rated child behaviors, or parent-rated social competence. For English-language skills, children who were dual language learners (DLLs) benefitted more from treatment than non-DLLs. Analyses of outcomes by child care type, regardless of treatment group assignment, showed that children in Educare had better language, math, and behavioral scores than children in less formal care, whereas children in other center-based care only had higher language scores than children in less formal care. Differences in outcomes between Educare and other center-based care were not significant.",2020,"The effectiveness of Educare, a center-based early education program, in improving child outcomes at age 3 was evaluated in a randomized clinical trial.","['239 children from low-income families who were randomly assigned as infants (<19 months) to', 'children who were dual language learners (DLLs) benefitted more from treatment than non-DLLs']","['Educare or a business-as-usual control group', 'Educare, a center-based early education program']","['language, math, and behavioral scores', 'auditory language skills, early math skills, and parent-reported problem behaviors', 'language scores', 'observations of parent-child interactions, observer-rated child behaviors, or parent-rated social competence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}]",202.0,0.0582288,"The effectiveness of Educare, a center-based early education program, in improving child outcomes at age 3 was evaluated in a randomized clinical trial.","[{'ForeName': 'Noreen', 'Initials': 'N', 'LastName': 'Yazejian', 'Affiliation': 'University of North Carolina at Chapel Hill, United States.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Bryant', 'Affiliation': 'University of North Carolina at Chapel Hill, United States.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Kuhn', 'Affiliation': 'University of North Carolina at Chapel Hill, United States.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Burchinal', 'Affiliation': 'University of North Carolina at Chapel Hill, United States.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Horm', 'Affiliation': 'University of Oklahoma-Tulsa, United States.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Hans', 'Affiliation': 'University of Chicago, United States.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'File', 'Affiliation': 'University of Wisconsin-Milwaukee, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Jackson', 'Affiliation': 'University of Nebraska Medical Center, United States.'}]",Early childhood research quarterly,['10.1016/j.ecresq.2020.05.008']
2129,33149400,Comparative Evaluation of the Remineralizing Efficacy of Fluoride Varnish and its Combination Varnishes on White Spot Lesions in Children with ECC: A Randomized Clinical Trial.,"Aim
The aim of the study was to assess the remineralizing efficacy of fluoride and its combination varnishes on white spot lesion (WSL) in children with early childhood caries (ECC).
Materials and methods
Sixty children with active WSL on primary maxillary anterior teeth were randomly selected. At baseline, the WSL activity was evaluated using ICDAS II [lesion activity assessment (LAA)] and its dimensions through photographic method. They were allocated to group I (GI) (5% NaF), group II (GII) [5% NaF with amorphous calcium phosphate (ACP)], and group III (GIII) [5% NaF with casein phosphopeptides - amorphous calcium phosphate (CPP -ACP)]. First, oral hygiene instructions and diet counseling were given followed by application of fluoride varnishes in their respective groups. The same parameters were recorded at follow-up of 2, 4, 12, and 24 weeks intervals. Data were collected and subjected to statistical analysis using Friedman Chi-square and Mann-Whitney tests.
Results
Overall, the active WSL changed to inactive over a period of 24 weeks in GI was 90%, GII was 95%, and 100% in GIII. There was a significant reduction in dimension of WSL in GI from 4.119 to 2.525 ( p = 0.0001). Likewise, there was a significant reduction in dimension of WSL in GII and GIII from 4.586 to 3.258 and 4.696 to 1.2155, respectively ( p = 0.0001, p = 0.0001). Comparatively, group III (MI varnish) showed statistically significant reduction in the dimension of WSL from baseline to 24 weeks ( p = 0.002). But the results were statistically insignificant with change of active lesions to its inactivity ( p = 0.349).
Conclusion
Fluoride varnish with CPP-ACP was found to be an effective preventive strategy in reversing WSL in children with ECC.
Clinical relevance
These combination varnishes could prove to be a promising preventive measure for pediatric dentists in reversing white spot lesions of ECC.
Clinical trial registry
NCT03360266.
How to cite this article
Radha S, Kayalvizhi G, Adimoulame S, et al. Comparative Evaluation of the Remineralizing Efficacy of Fluoride Varnish and its Combination Varnishes on White Spot Lesions in Children with ECC: A Randomized Clinical Trial. Int J Clin Pediatr Dent 2020;13(4):311-317.",2020,"But the results were statistically insignificant with change of active lesions to its inactivity ( p = 0.349).
","['Children with ECC', 'children with ECC', 'Sixty children with active WSL on primary maxillary anterior teeth', 'children with early childhood caries (ECC']","['NaF with casein phosphopeptides - amorphous calcium phosphate (CPP -ACP', 'fluoride and its combination varnishes', 'Fluoride varnish with CPP-ACP', 'NaF with amorphous calcium phosphate (ACP', 'Fluoride Varnish and its Combination Varnishes']","['WSL activity', 'ICDAS II [lesion activity assessment (LAA', 'white spot lesion (WSL', 'dimension of WSL', 'White Spot Lesions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}, {'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}]","[{'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",60.0,0.0322,"But the results were statistically insignificant with change of active lesions to its inactivity ( p = 0.349).
","[{'ForeName': 'Sarangapani', 'Initials': 'S', 'LastName': 'Radha', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, JKK Nattraja Dental College and Hospital, Komarapalayam, Namakkal, Tamil Nadu, India.'}, {'ForeName': 'Gurusamy', 'Initials': 'G', 'LastName': 'Kayalvizhi', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Dr Syamala Reddy Dental College and Hospital, Bengaluru, Karnataka, India.'}, {'ForeName': 'Sanguida', 'Initials': 'S', 'LastName': 'Adimoulame', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth (Deemed to be University), Puducherry, India.'}, {'ForeName': 'Gajula S', 'Initials': 'GS', 'LastName': 'Prathima', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth (Deemed to be University), Puducherry, India.'}, {'ForeName': 'Kirthika', 'Initials': 'K', 'LastName': 'Muthusamy', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Faculty of Dental Sciences, Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ezhumalai', 'Affiliation': 'Department of Statistics, Mahatma Gandhi Medical College and Research Institute, SBV, Puducherry, India.'}, {'ForeName': 'Nagendrababu', 'Initials': 'N', 'LastName': 'Jagadesaan', 'Affiliation': 'Department of Prosthodontics and Crown and Bridge, JKK Nattraja Dental College and Hospital, Komarapalayam, Namakkal, Tamil Nadu, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1673']
2130,33149401,"""Thaumaturgy""- A Novel Behavior-shaping Technique.","Aim
To compare and evaluate the effectiveness of thaumaturgy in alleviation of anxiety in children aged 2-13 years.
Materials and methods
Two hundred and forty children aged 2-13 years, identified as manifesting strong-willed behavior were selected for this study. The children were randomly assigned to be managed by one of the three thaumaturgic distraction techniques. Anxiety was assessed before and after the local anesthetic procedure using the anxiety facial scale.
Results
There was a significant decrease in anxiety with the use of thaumaturgic techniques. Thumb and light trick significantly reduced anxiety in children aged 2-7 years, book trick reduced anxiety in children aged 7-11 years, and item tricks in children aged 11-13 years.
Conclusion
The use of thaumaturgy plays an important role in shaping the behavior of a child in pediatric dentistry. The age and cognitive development of child dictates the technique to be used.
Clinical significance
Thaumaturgy helps to render effective dental treatment in uncooperative children and instill a positive attitude.
How to cite this article
Konde S, Sumaiyya S, Agarwal M, et al. ""Thaumaturgy""-A Novel Behavior-shaping Technique. Int J Clin Pediatr Dent 2020;13(4):318-321.",2020,"Thumb and light trick significantly reduced anxiety in children aged 2-7 years, book trick reduced anxiety in children aged 7-11 years, and item tricks in children aged 11-13 years.
","['children aged 2-7 years, book trick reduced anxiety in children aged 7-11 years, and item tricks in children aged 11-13 years', 'children aged 2-13 years', 'uncooperative children', 'Two hundred and forty children aged 2-13 years, identified as manifesting strong-willed behavior']","['Thaumaturgy', 'Thumb and light trick']","['anxiety facial scale', 'Anxiety', 'anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0424350', 'cui_str': 'Uncooperative behavior'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",240.0,0.0211097,"Thumb and light trick significantly reduced anxiety in children aged 2-7 years, book trick reduced anxiety in children aged 7-11 years, and item tricks in children aged 11-13 years.
","[{'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Konde', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, AECS Maaruti College of Dental Sciences and Research Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'Saleem', 'Initials': 'S', 'LastName': 'Sumaiyya', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, AECS Maaruti College of Dental Sciences and Research Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, AECS Maaruti College of Dental Sciences and Research Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'Preetha', 'Initials': 'P', 'LastName': 'Peethambar', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, AECS Maaruti College of Dental Sciences and Research Centre, Bengaluru, Karnataka, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1781']
2131,33154086,Novel electronic adherence monitoring devices in children with asthma: a mixed-methods study.,"INTRODUCTION
Adherence monitoring to inhaled corticosteroids is an essential component of asthma management. Electronic monitoring devices (EMD) provide objective data on date, time and number of actuations. However, most give no information on inhalation. Novel EMD (NEMD) platforms have the potential to monitor both activation and inhalation.
AIM
To assess the feasibility of NEMDs, in terms of usability, acceptability to patients and healthcare professionals and accuracy.
METHODS
This was an open-label, prospective, mixed-methods, pragmatic randomised study. Children with asthma attending specialist tertiary care were randomised to one of four NEMD: Remote Directly Observed Therapy (R-DOT), Hailie Smartinhaler, INhaler Compliance Assessment device (INCA) and the Rafi-tone App. Following monitoring, participants were invited to focus groups or one-to-one interviews. Usability and acceptability were evaluated using themes identified from the focus groups and interviews. Adherence accuracy was determined using adherence data from each NEMD.
RESULTS
Thirty-five children were recruited; 18 (51%), (11 males, median age 13.5 (7-16) years) completed monitoring, 14 (78%) provided feedback. Participants identified various features such as ease of use and minimal effort as desirable criteria for an NEMD. The Hailie and INCA fulfilled these criteria and were able to record both actuation and inhalation. Negative themes included a 'Big Brother' effect and costs.
CONCLUSION
There was no 'one size fits all', as participants identified advantages and disadvantages for each NEMD. Devices that can easily calculate adherence to activation and inhalation have the potential to have greatest utility in clinical practice. Each NEMD has different functionality and therefore choice of platform should be determined by the needs of the patient and healthcare professional.",2020,Children with asthma attending specialist tertiary care were randomised to one of four NEMD:,"['children with asthma', 'Thirty-five children were recruited; 18 (51%), (11 males, median age 13.5 (7-16) years) completed monitoring, 14 (78%) provided feedback', 'Children with asthma attending specialist tertiary care']","['NEMD', 'Novel electronic adherence monitoring devices', 'Novel EMD (NEMD) platforms', 'Electronic monitoring devices (EMD']","[""Big Brother' effect and costs"", 'Usability and acceptability', 'Remote Directly Observed Therapy (R-DOT), Hailie Smartinhaler, INhaler Compliance Assessment device (INCA) and the Rafi-tone App', 'Adherence accuracy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517559', 'cui_str': '13.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0340861', 'cui_str': 'Electromechanical dissociation'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0336646', 'cui_str': 'Electronic monitor'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0337527', 'cui_str': 'Brother'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C1161275', 'cui_str': 'Compliance care assessment'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",35.0,0.0502511,Children with asthma attending specialist tertiary care were randomised to one of four NEMD:,"[{'ForeName': 'Sukeshi', 'Initials': 'S', 'LastName': 'Makhecha', 'Affiliation': 'Paediatrics, Respiratory, Royal Brompton Hospital, London, London, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'The University of Auckland School of Pharmacy, Auckland, Auckland, New Zealand.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pearce', 'Affiliation': 'Centre of Behavioural Medicine, School of Pharmacy, UCL, London, London, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jamalzadeh', 'Affiliation': 'Paediatrics, Respiratory, Royal Brompton Hospital, London, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Fleming', 'Affiliation': 'Paediatrics, Respiratory, Royal Brompton Hospital, London, London, UK l.fleming@rbht.nhs.uk.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000589']
2132,33149495,Effect of Green Tea Extract Mouthrinse and Probiotic Mouthrinse on Salivary pH in a Group of Schoolchildren: An In Vivo Study.,"Aim and Objective
The aim of the study was to assess the efficacy of probiotic and green tea mouthrinse on salivary pH.
Materials and Methods
This study was conducted over a period of 1 month among 40 healthy schoolchildren aged between 6 and 8 years. The subjects who fulfilled inclusion criteria were selected and randomly divided into two groups, namely probiotic and green tea groups. Salivary pH was recorded at baseline (0 day) and at the end of the specified time using GC pH strips. Statistical analysis was done using paired t test. P < 0.05 was considered statistically significant.
Result
The comparison of mean pH scores for green tea showed that the pH of saliva was increased in the children after rinsing with green tea (6.00-7.60) and was statistically significant ( P < 0.001). Similarly, when pre- and post-mean pH was compared in the probiotic group, the pH was found to be higher in the probiotic rinse group (5.60-7.20). The results were statistically significant.
Conclusion
The study conducted shows the beneficial effects of green tea in providing a alkaline environment, which is conducive to the oral health of children.",2020,The comparison of mean pH scores for green tea showed that the pH of saliva was increased in the children after rinsing with green tea (6.00-7.60) and was statistically significant ( P < 0.001).,"['subjects who fulfilled inclusion criteria', 'a Group of Schoolchildren', '40 healthy schoolchildren aged between 6 and 8 years']","['namely probiotic and green tea groups', 'green tea', 'Green Tea Extract Mouthrinse and Probiotic Mouthrinse', 'probiotic and green tea mouthrinse', 'probiotic rinse']","['mean pH scores', 'pH of saliva', 'Salivary pH']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",40.0,0.0559741,The comparison of mean pH scores for green tea showed that the pH of saliva was increased in the children after rinsing with green tea (6.00-7.60) and was statistically significant ( P < 0.001).,"[{'ForeName': 'Saranya', 'Initials': 'S', 'LastName': 'Manikandan', 'Affiliation': 'Department of Oral Pathology, Vivekanandha Dental College for Women, Tiruchengode, Tamil Nadu, India.'}, {'ForeName': 'Subasish', 'Initials': 'S', 'LastName': 'Behera', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Hi-Tech Dental College and Hospital, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Radhakrishnan', 'Initials': 'R', 'LastName': 'Karthikeyan', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Sri Ramakrishna Dental College and Hospital, Coimbatore, Tamil Nadu, India.'}, {'ForeName': 'Arumugasamy', 'Initials': 'A', 'LastName': 'Niranjana', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Sri Ramakrishna Dental College and Hospital, Coimbatore, Tamil Nadu, India.'}, {'ForeName': 'Rajendran', 'Initials': 'R', 'LastName': 'Bharathan', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Sri Ramakrishna Dental College and Hospital, Coimbatore, Tamil Nadu, India.'}, {'ForeName': 'Omar Farooq Burhanuddin', 'Initials': 'OFB', 'LastName': 'Mohammed', 'Affiliation': 'Department of Conservative & Endodontics, Tagore Dental College & Hospital, Chennai, Tamil Nadu, India.'}]",Journal of pharmacy & bioallied sciences,['10.4103/jpbs.JPBS_119_20']
2133,33149503,Assessment of Efficacy of 5% Topical Amlexanox and 0.1% Topical Triamcinolone Acetonide in Management of Recurrent Aphthous Stomatitis.,"Aim
The aim of this study was to assess the efficacy of 5% topical amlexanox and 0.1% topical triamcinolone acetonide in recurrent aphthous stomatitis (RAS) management.
Materials and Methods
Sixty adult patients of RAS of both genders were divided into two groups with each group having 30 patients. In group I, 0.1% topical triamcinolone acetonide was prescribed. In group II, 5% topical amlexanox was prescribed. Patients were recalled regularly and size of ulcer, erythema, and pain score was recorded on days 1, 3, and 5.
Results
The mean ulcer size (mm) on day 1 in group I was 4.3 and in group II it was 4.1, on day 3 it was 3.5 in group I and in group II it was 3.6, on day 5 in group I it was 1.3 and in group II it was 1.7. The result was not statistically significant ( P > 0.05). The mean pain score recorded on visual analog scale was in descending grade day by day on first, third, and fifth days. In group I, healing was seen in 29 (96.6%) patients and in 28 (93.3%) patients in group II. Partially healing was seen in 1 (3.3%) patient in each group, whereas in group II nonhealing was observed in 1 (3.3%) patient. The statistical significance was not achieved as P > 0.05.
Conclusion
Authors found that above drugs were effective in reducing pain, size of ulcer, erythema, and improving healing in patients with recurrent aphthous stomatitis. There were better results with triamcinolone acetonide as comparison of amlexanox.",2020,"Partially healing was seen in 1 (3.3%) patient in each group, whereas in group II nonhealing was observed in 1 (3.3%) patient.","['Recurrent Aphthous Stomatitis', 'patients with recurrent aphthous stomatitis', 'recurrent aphthous stomatitis (RAS) management', 'Sixty adult patients of RAS of both genders']","['topical amlexanox', 'Topical Amlexanox and 0.1% Topical Triamcinolone Acetonide', 'topical amlexanox and 0.1% topical triamcinolone acetonide', 'triamcinolone acetonide']","['mean pain score', 'visual analog scale', 'recalled regularly and size of ulcer, erythema, and pain score', 'pain, size of ulcer, erythema, and improving healing', 'healing', 'Partially healing', 'mean ulcer size']","[{'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0103049', 'cui_str': 'amlexanox'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",60.0,0.016583,"Partially healing was seen in 1 (3.3%) patient in each group, whereas in group II nonhealing was observed in 1 (3.3%) patient.","[{'ForeName': 'Kumari', 'Initials': 'K', 'LastName': 'Kavita', 'Affiliation': 'Department of Dentistry, Nalanda Medical College and Hospital, Patna, Bihar, India.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Prosthodontics, Crown, Bridge and Implantology, Patna Dental College & Hospital, Patna, Bihar, India.'}, {'ForeName': 'Revati', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Dentistry, Patna Medical College and Hospital (PMCH), Patna, Bihar, India.'}, {'ForeName': 'Sudhir', 'Initials': 'S', 'LastName': 'Gonuguntla', 'Affiliation': 'Department of Oral and Maxillofacial Pathology, Malla Reddy Institute of Dental Sciences, Hyderabad, Telangana, India.'}, {'ForeName': 'Alexander Maniangat', 'Initials': 'AM', 'LastName': 'Luke', 'Affiliation': 'Department of Surgical Sciences, College of Dentistry, Ajman University, Ajman, UAE.'}, {'ForeName': 'Harshvardhan Shridhar', 'Initials': 'HS', 'LastName': 'Jois', 'Affiliation': 'Department of Oral Pathology, Army College of Dental Sciences, Secunderabad, Telangana, India.'}]",Journal of pharmacy & bioallied sciences,['10.4103/jpbs.JPBS_133_20']
2134,33149527,Comparative Evaluation of Antimicrobial Efficacy of Toothpastes Containing Probiotic and Neem as Primary Ingredient on Salivary Streptococcus mutans in Melmaruvathur Population: An In Vivo Study.,"Aim
This in vivo study was designed to compare the antimicrobial effect of toothpastes containing probiotics and neem on Streptococcus mutans in 18-30-year-old patients in Melmaruvathur population.
Materials and Methods
The study consisted of 60 patients who were randomly divided into two groups of 30 each. Group I received probiotic-based toothpaste (PerioBiotic), whereas Group II received neem-based toothpaste (Babool) as a preventive measure protocols to control the incidence and prevalence of dental caries.
Study Design Protocols
Participants were instructed to use the dentifrice selected for the study, two times a day for 60 days. Tests were performed on the saliva samples at the beginning of the study, 0 day, 15th day, 30th day, and 60th day following the use of toothpaste. The Statistical Package for the Social Sciences (SPSS-25) software, version, and Chi-square and one-way analysis of variance were used for data analysis.
Results
The toothpastes containing neem and probiotics as primary ingredients were efficient in reducing the number of bacterial count when comparing the baseline data with the 60 days data in both the groups as a therapeutic regimen. Intragroup values showed reduction in the number of bacterial count in both the groups in a gradual manner, whereas the intergroup values between the toothpaste showed no statistically significant difference in the bacterial count, and both toothpastes were efficient in reducing the bacterial count.
Conclusion
This study reveals the influence of probiotics and neem on salivary S. mutans levels. The results revealed that neem-based and probiotic-based toothpaste, which were tested in this study, showed comparable antibacterial activity against the S. mutans . The neem-based toothpaste showed promising and good antimicrobial activity and reduced the level of bacterial count, which can be attributed to the presence of secondary metabolites, such as flavonoids, alkaloids, lectins, and polyphenols, as its active components. The effect of each component against the S. mutans needs to be quantified in further studies, and within the limitation of this short study, it can be considered as a better choice than commercially available toothpaste, which predominantly has chemicals as active ingredients, which in turn can compromise the safety aspects in the patients when used for controlling the dental caries for a longer duration.",2020,The toothpastes containing neem and probiotics as primary ingredients were efficient in reducing the number of bacterial count when comparing the baseline data with the 60 days data in both the groups as a therapeutic regimen.,"['18-30-year-old patients in Melmaruvathur population', 'Salivary Streptococcus mutans in Melmaruvathur Population', '60 patients who were randomly divided into two groups of 30 each']","['probiotic-based toothpaste (PerioBiotic), whereas Group II received neem-based toothpaste (Babool', 'Toothpastes Containing Probiotic and Neem', 'toothpastes containing probiotics']",['number of bacterial count'],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1095052', 'cui_str': 'Melia azadirachta'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}]",60.0,0.020007,The toothpastes containing neem and probiotics as primary ingredients were efficient in reducing the number of bacterial count when comparing the baseline data with the 60 days data in both the groups as a therapeutic regimen.,"[{'ForeName': 'Karthikeyan', 'Initials': 'K', 'LastName': 'Selvaraj', 'Affiliation': 'Reader, Adhiparasakthi Dental College, Melmaruvathur, Tamil Nadu, India.'}, {'ForeName': 'Nagareddy', 'Initials': 'N', 'LastName': 'Bharath', 'Affiliation': 'Reader, Adhiparasakthi Dental College, Melmaruvathur, Tamil Nadu, India.'}, {'ForeName': 'Raghunathan', 'Initials': 'R', 'LastName': 'Natarajan', 'Affiliation': 'Tagore Dental College Rathinamangalam, Tamil Nadu, India.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Dinesh', 'Affiliation': 'Professor, Sri Venkateshwara Dental College, Pondicherry, India.'}, {'ForeName': 'Sabari', 'Initials': 'S', 'LastName': 'Murugesan', 'Affiliation': 'Assistant Professor, College of Dentistry, Jazan University, King Abdulaziz Road, Kingdom of Saudi Arabia.'}, {'ForeName': 'Saravanan', 'Initials': 'S', 'LastName': 'Selvaraj', 'Affiliation': 'Madha Dental College Kundrathur, Tamil Nadu, India.'}]",Journal of pharmacy & bioallied sciences,['10.4103/jpbs.JPBS_209_20']
2135,33149563,Feasibility of a Mobile Meal Assistance Program for Direct Care Workers in Long-Term Care Facilities in South Korea.,"Purpose
The purpose of this study was to assess the feasibility and examine the preliminary effectiveness of a mobile application-based meal assistant training program (APP) for use by direct care workers (CAs) assisting residents with dementia in long-term care facilities in South Korea.
Methods
We adopted a mixed methods research design, which included a pre- and post-intervention study and focus group interviews for the feasibility assessment. Participants included 23 dyads of older adults with dementia and their CAs from a long-term care facility in South Korea. Upon completion of the APP intervention, focused group interviews were conducted with six CAs and five nurses.
Results
The results of paired t -tests showed that the effects of the APP intervention on the older adults with dementia and their CAs were not significant; however, the results of the focused group interviews support the potential usefulness of the APP for CAs.
Conclusion
The APP may be applicable to long-term care workers who need meal assistant skills education.",2020,"The results of paired t -tests showed that the effects of the APP intervention on the older adults with dementia and their CAs were not significant; however, the results of the focused group interviews support the potential usefulness of the APP for CAs.
","['Participants included 23 dyads of older adults with dementia and their CAs from a long-term care facility in South Korea', 'Direct Care Workers in Long-Term Care Facilities in South Korea', 'direct care workers (CAs) assisting residents with dementia in long-term care facilities in South Korea', 'older adults with dementia and their CAs']","['mobile application-based meal assistant training program (APP', 'APP intervention', 'Mobile Meal Assistance Program']",[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],23.0,0.0220109,"The results of paired t -tests showed that the effects of the APP intervention on the older adults with dementia and their CAs were not significant; however, the results of the focused group interviews support the potential usefulness of the APP for CAs.
","[{'ForeName': 'Dukyoo', 'Initials': 'D', 'LastName': 'Jung', 'Affiliation': 'College of Nursing, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Jennie C', 'Initials': 'JC', 'LastName': 'De Gagne', 'Affiliation': 'School of Nursing, Duke University, Durham, NC, USA.'}, {'ForeName': 'Minkyung', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Hyesoon', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Kyuri', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Eunju', 'Initials': 'E', 'LastName': 'Choi', 'Affiliation': 'College of Nursing, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Juyoun', 'Initials': 'J', 'LastName': 'Chung', 'Affiliation': 'Department of Comics and Animation Technology, Sejong University, Seoul, South Korea.'}]",Clinical interventions in aging,['10.2147/CIA.S273934']
2136,33149656,Comparison of Hemodialysis Using a Medium Cutoff Dialyzer versus Hemodiafiltration: A Controlled Cross-Over Study.,"Purpose
Conventional hemodialysis (HD) treatment has an acceptable removal of small uremic molecules, but so-called ""middle molecules"" in the range of 0.5-60 kDa are poorly cleared with HD compared to a native kidney, which may contribute to morbidity in the dialysis population. Hemodiafiltration (HDF) has a better removal of middle molecules compared to HD but is technically demanding and requires well-functioning dialysis access. The newly introduced medium cutoff (MCO) filters have been developed to enhance middle molecule clearance in HD-mode. The aim of this study was to compare reduction ratios (RRs) of molecules with different molecular weights (0.06-150 kDa) during dialysis with MCO dialyzer (used in HD-mode) compared to online-hemodiafiltration (ol-HDF) treatment with a conventional high-flux dialyzer.
Patients and Methods
This is a prospective controlled single-center cross-over study, including 16 patients in Malmö, Sweden. All patients had ongoing post-dilution ol-HDF treatment before the study. The study compared reduction ratios of small-, middle-, and large-sized molecules during a single 4h dialysis treatment with post-dilution ol-HDF (Polyflux 210H) to a 4h dialysis treatment with MCO dialyzer (Theranova 500) in HD-mode. Between treatments, the patients had a washout period of at least two weeks of their ordinary HDF treatment to reach their ordinary steady state.
Results
ol-HDF had significantly higher RR for cystatin C (13 kDa), compared to MCO (RR 68.1 vs 65.8, p=0.003), during a 4h dialysis treatment (mean convection volume of 24.5 L for HDF, and mean Q b of 324 mL/min for HDF and 323 mL/min for MCO). There was no significant difference in the RR for other middle molecules, or for smaller or larger molecules.
Conclusion
Overall, the RRs were comparable for ol-HDF and MCO-HD. There was a slightly higher RR of cystatin C (a small middle molecule) for HDF compared to MCO but no difference in other measured molecules.",2020,There was a slightly higher RR of cystatin C (a small middle molecule) for HDF compared to MCO but no difference in other measured molecules.,"['16 patients in Malmö, Sweden']","['Conventional hemodialysis (HD) treatment', 'Hemodiafiltration (HDF', 'MCO dialyzer (Theranova 500) in HD-mode', 'Hemodialysis Using a Medium Cutoff Dialyzer versus Hemodiafiltration', 'dialysis with MCO dialyzer (used in HD-mode) compared to online-hemodiafiltration (ol-HDF) treatment with a conventional high-flux dialyzer']","['reduction ratios (RRs) of molecules with different molecular weights', 'RR of cystatin C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}]",,0.0148611,There was a slightly higher RR of cystatin C (a small middle molecule) for HDF compared to MCO but no difference in other measured molecules.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lindgren', 'Affiliation': 'Department of Nephrology, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Fjellstedt', 'Affiliation': 'Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Christensson', 'Affiliation': 'Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden.'}]",International journal of nephrology and renovascular disease,['10.2147/IJNRD.S263110']
2137,33149671,"Outcomes of 596 Advanced Gastric Cancer Patients with Different Numbers of Chemotherapy Lines: The More Chemotherapy Lines, the Better Survival.","Objective
Many large-sample prospective randomized clinical trials investigating advanced gastric cancer (AGC) have confirmed the survival advantages of first-line, second-line, or third-line chemotherapy compared with their respective control groups. However, due to the ethical concerns of prospective clinical trials, it is impossible to conduct a randomized comparative study of patients who do not receive chemotherapy and those who receive a second-line or above chemotherapy. Few research reports have addressed the relationship between the number of chemotherapy lines and overall survival (OS) in patients with AGC. In the present study, we analyzed the impact of the number of chemotherapy lines on OS in AGC patients using real-world data.
Patients and Methods
This study collected the medical records of patients with AGC diagnosed at Shandong Cancer Hospital from December 2007 to December 2017. According to the treatment received, AGC patients were divided into groups that did not receive chemotherapy, those who received only 1 line, 2 lines, or 3 lines and above. Kaplan-Meier analysis was used to assess patient survival.
Results
A total of 596 AGC patients were included in this study. The following patients were enrolled: 0 lines (did not receive chemotherapy), 77 (12.9%); 1 line, 235 (39.4%) patients; 2 lines, 185 (31.1%) patients; and ≥3 lines 99 (16.6%) patients. OS was significantly correlated with the number of chemotherapy lines (P<0.001), with a median OS from diagnosis of 3.3, 8.6, 15.6, and 21.0 months for patients receiving 0, 1, 2, ≥3 lines of chemotherapy, respectively.
Conclusion
This study showed that the more chemotherapy lines AGC patients received, the longer the OS. This study not only confirmed the impact of chemotherapy lines on OS but it also supplements the results of prospective clinical trials that cannot be completed due to the ethical implications.",2020,"OS was significantly correlated with the number of chemotherapy lines (P<0.001), with a median OS from diagnosis of 3.3, 8.6, 15.6, and 21.0 months for patients receiving 0, 1, 2, ≥3 lines of chemotherapy, respectively.
","['patients with AGC diagnosed at Shandong Cancer Hospital from December 2007 to December 2017', 'patients with AGC', '596 Advanced Gastric Cancer Patients with Different Numbers of Chemotherapy Lines', '596 AGC patients', 'advanced gastric cancer (AGC', 'patients who do not receive chemotherapy and those who receive a second-line or above chemotherapy', 'AGC patients using real-world data']",[],"['patient survival', 'overall survival (OS', 'OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",596.0,0.0485742,"OS was significantly correlated with the number of chemotherapy lines (P<0.001), with a median OS from diagnosis of 3.3, 8.6, 15.6, and 21.0 months for patients receiving 0, 1, 2, ≥3 lines of chemotherapy, respectively.
","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': ""Department of Gastroenterology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, People's Republic of China.""}, {'ForeName': 'Huijun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, People's Republic of China.""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': ""Department of Gastroenterology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, People's Republic of China.""}, {'ForeName': 'Meiqing', 'Initials': 'M', 'LastName': 'Qiu', 'Affiliation': ""Department of Oncology, Zaozhuang Municipal Hospital, Zaozhuang, People's Republic of China.""}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Ju', 'Affiliation': ""Department of Gastroenterology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, People's Republic of China.""}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, People's Republic of China.""}]",Cancer management and research,['10.2147/CMAR.S275990']
2138,33149896,"Effect of sodium hypochlorite solution and gel with/without passive ultrasonic irrigation on Enterococcus faecalis , Escherichia coli and their endotoxins.","Background: Sodium hypochlorite (NaOCl) is the most commonly used irrigant in endodontics . The purpose of this study was to evaluate the effect of NaOCl solution (2.5%) and gel (3%) with/without passive ultrasonic irrigation (PUI) on Enterococcus faecalis, Escherichia coli, and their endotoxins, lipopolysaccharide (LPS) and lipoteichoic acid (LTA). Methods: 40 human lower premolars were contaminated with E. coli (ATCC 25922) for 28 days and E. faecalis (ATCC 29212) for 21 days. Specimens were randomly divided into four groups: (1) 2.5% NaOCl irrigating the canals without PUI activation; (2) 2.5% NaOCl with PUI; (3) 3% NaOCl gel irrigating the canals without PUI; and (4) 3% NaOCl gel with PUI. 40 mL of irrigant was used for each group. PUI activation was carried out using E1-Irrisonic stainless-steel tip at 10% frequency. After treatment, all specimens were filled with 3mL of 17% ethylenediaminetetraacetic acid (EDTA) for 3min and then washed with nonpyrogenic saline solution. Three samples were collected from the canals: S1, at baseline to confirm biofilm formation; S2 after treatment; and S3 after EDTA. Samples were assessed for E. coli and E. faecalis colony forming units, and LPS and LTA were assessed using chromogenic kinetic LAL assay and ELISA, respectively. Data were analyzed by Kruskal-Wallis, Friedmann and Dunn tests with α≤0.05. Results : All groups were effective in reducing the microbial load of E. coli and E. faecalis after treatment without a significant difference among the groups. NaOCl and NaOCl gel groups had no significant difference in reducing LPS and LTA. Statistically increased reduction was seen for NaOCL + PUI and NaOCl gel + PUI compared for groups without PUI. Conclusions: NaOCl gel has the same antimicrobial action of NaOCl solution and can partially detoxify endotoxins. PUI improves NaOCl (gel or solution) action over E. faecalis and E. coli and their endotoxins.",2020,Statistically increased reduction was seen for NaOCL + PUI and NaOCl gel + PUI compared for groups without PUI. ,['40 human lower premolars were contaminated with E. coli (ATCC 25922) for 28 days and E. faecalis (ATCC 29212) for 21 days'],"['NaOCl gel', 'NaOCl irrigating the canals without PUI activation; (2) 2.5% NaOCl with PUI; (3) 3% NaOCl gel irrigating the canals without PUI; and (4) 3% NaOCl gel with PUI', 'NaOCl solution (2.5%) and gel (3%) with/without passive ultrasonic irrigation (PUI', 'nonpyrogenic saline solution', 'NaOCl and NaOCl gel', 'sodium hypochlorite solution and gel with/without passive ultrasonic irrigation', 'ethylenediaminetetraacetic acid (EDTA', 'Sodium hypochlorite (NaOCl']","['Enterococcus faecalis , Escherichia coli and their endotoxins', 'LPS and LTA', 'microbial load of E. coli and E. faecalis', 'Enterococcus faecalis, Escherichia coli, and their endotoxins, lipopolysaccharide (LPS) and lipoteichoic acid (LTA', 'PUI activation', 'PUI improves NaOCl (gel or solution) action']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}]","[{'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0014264', 'cui_str': 'Bacterial endotoxin'}, {'cui': 'C2729610', 'cui_str': 'LTA'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0065067', 'cui_str': 'lipoteichoic acid'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0441472', 'cui_str': 'Action'}]",,0.0446105,Statistically increased reduction was seen for NaOCL + PUI and NaOCl gel + PUI compared for groups without PUI. ,"[{'ForeName': 'Amjad', 'Initials': 'A', 'LastName': 'Abu Hasna', 'Affiliation': 'Department of Restorative Dentistry, Endodontic Division., São Paulo State University (UNESP), Institute of Science and Technology, São José dos Campos, São Paulo, 12245000, Brazil.'}, {'ForeName': 'Laiana', 'Initials': 'L', 'LastName': 'Pereira Da Silva', 'Affiliation': 'Department of Restorative Dentistry, Endodontic Division., São Paulo State University (UNESP), Institute of Science and Technology, São José dos Campos, São Paulo, 12245000, Brazil.'}, {'ForeName': 'Fernanda Carvalho', 'Initials': 'FC', 'LastName': 'Pelegrini', 'Affiliation': 'Department of Restorative Dentistry, Endodontic Division., São Paulo State University (UNESP), Institute of Science and Technology, São José dos Campos, São Paulo, 12245000, Brazil.'}, {'ForeName': 'Cláudia Luísa Ribeiro', 'Initials': 'CLR', 'LastName': 'Ferreira', 'Affiliation': 'Department of Restorative Dentistry, Endodontic Division., São Paulo State University (UNESP), Institute of Science and Technology, São José dos Campos, São Paulo, 12245000, Brazil.'}, {'ForeName': 'Luciane Dias', 'Initials': 'LD', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Biosciences and Oral Diagnosis, São Paulo State University (UNESP), Institute of Science and Technology, São José dos Campos, São Paulo, 12245000, Brazil.'}, {'ForeName': 'Cláudio Antonio Talge', 'Initials': 'CAT', 'LastName': 'Carvalho', 'Affiliation': 'Department of Restorative Dentistry, Endodontic Division., São Paulo State University (UNESP), Institute of Science and Technology, São José dos Campos, São Paulo, 12245000, Brazil.'}]",F1000Research,['10.12688/f1000research.24721.1']
2139,33149944,Bleb Morphology Using Anterior-Segment Optical Coherence Tomography after Ahmed Glaucoma Valve Surgery with Tenon Capsule Resection.,"Objectives
To evaluate the internal morphology of blebs using anterior-segment optical coherence tomography (AS-OCT) and the surgical outcomes of Ahmed glaucoma valve (AGV) surgery with Tenon capsule resection compared to conventional AGV surgery in patients with refractory glaucoma. Patients and Methods . This randomised prospective study included 30 eyes from 30 patients (age range: 42-55 y) with refractory glaucoma from March 2018 to February 2020. The study included two groups: AGV with the Tenon capsule resection group ( n = 15) and the conventional AGV surgery group ( n = 15). Follow-up continued until 6 months after surgery. The primary outcome was intraocular pressure (IOP) and its association with the number of postoperative glaucoma medications, best corrected visual acuity, visual field, and postoperative complications. The internal morphology of the blebs in both groups was evaluated at 1-day, 1-week, 1-month, 3-month, and 6-month follow-up using AS-OCT in terms of the consequent changes in bleb wall thickness, bleb wall reflectivity, and bleb cavity morphology throughout the 6-month follow-up period.
Results
A significant reduction in IOP was found in both groups, with a greater reduction in group I, where the mean IOP decreased from 32.73 ± 2.12 mmHg in the preoperative period to 13.33 ± 1.59 mmHg after 6 months, whereas in group II, the mean IOP decreased from 33.2 ± 2.21 mmHg in the preoperative period to 14.27 ± 1.44 mmHg after 6 months ( p value <0.05). The difference between the 2 groups in terms of the decrease in IOP was insignificant except at 1 and 3 months, where there was a significant difference ( p value = 0.016 and 0.01 at 1 and 3 months, respectively). The bleb analysis revealed a significant reduction in the wall thickness in both groups at 1 and 3 months, which was mostly associated with the hypertensive phase. In group I, the bleb wall thickness decreased from 754.67 ± 53.93 μ m in the first postoperative day to 684 ± 81.66 μ m and 671.6 ± 69.48 μ m at 1 and 3 months, respectively, while in group II, the bleb wall thickness decreased from 707.13 ± 31.7 μ m in the first postoperative day to 499.53 ± 99.1 μ m and 506 ± 76.91 μ m at 1 and 3 months, respectively. There was a significant reduction in AS-OCT, and bleb reflectivity was insignificant throughout the follow-up period ( p value >0.05). Regarding postoperative complications, the hypertensive phase occurred more frequently in group II (6 eyes, 40%) than in group I (2 eyes, 13.3%). Other complications were also reported more frequently in group II such as hypotony, shallow anterior chamber (AC), and tube exposure.
Conclusion
AS-OCT was beneficial in the analysis of bleb morphology after AGV surgery where there were more diffuse functioning multicystic blebs and less thinning in the bleb wall thickness during the hypertensive phase after resection of the Tenon capsule, which might be related to the less incidence of fibrosis around the surgical site.",2020,"The difference between the 2 groups in terms of the decrease in IOP was insignificant except at 1 and 3 months, where there was a significant difference ( p value = 0.016 and 0.01 at 1 and 3 months, respectively).","['30 eyes from 30 patients (age range: 42-55\u2009y) with refractory glaucoma from March 2018 to February 2020', 'patients with refractory glaucoma']","['AGV with the Tenon capsule resection', 'conventional AGV surgery', 'blebs using anterior-segment optical coherence tomography (AS-OCT', 'Bleb Morphology Using Anterior-Segment Optical Coherence Tomography after Ahmed Glaucoma Valve Surgery with Tenon Capsule Resection', 'Ahmed glaucoma valve (AGV) surgery with Tenon capsule resection']","['hypotony, shallow anterior chamber (AC), and tube exposure', 'intraocular pressure (IOP) and its association with the number of postoperative glaucoma medications, best corrected visual acuity, visual field, and postoperative complications', 'wall thickness', 'bleb wall thickness, bleb wall reflectivity, and bleb cavity morphology', 'AS-OCT, and bleb reflectivity', 'hypertensive phase', 'IOP', 'bleb wall thickness', 'mean IOP']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C2586323', 'cui_str': ""Tenon's capsule structure""}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]","[{'cui': 'C0423276', 'cui_str': 'Shallow anterior chamber of eye'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",30.0,0.0160189,"The difference between the 2 groups in terms of the decrease in IOP was insignificant except at 1 and 3 months, where there was a significant difference ( p value = 0.016 and 0.01 at 1 and 3 months, respectively).","[{'ForeName': 'Faried M', 'Initials': 'FM', 'LastName': 'Wagdy', 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Menofia University, Shebeen El-Kom, Egypt.'}]",Journal of ophthalmology,['10.1155/2020/8386135']
2140,33150035,An Open-Label Prospective Study to Compare the Efficacy and Safety of Topical Fluticasone Versus Tacrolimus in the Proactive Treatment of Atopic Dermatitis.,"Background
Atopic dermatitis (AD), a chronic, recurrent inflammatory skin condition primarily affects children. Topical treatment, systemic treatment, and phototherapy are mainstays of treatment. Topical corticosteroids (TCS) are first-line therapy for AD but are associated with various adverse effects. Topical calcineurin inhibitors (TCI) can be used as an alternative to TCS.
Objective
The aim of the study is to compare the efficacy of topical preparations of fluticasone and tacrolimus in reducing the severity of disease and, to assess the quality of life (QoL), and to estimate if any association exists between severity of disease and QoL.
Methods
Thirty-seven children with AD randomly received one of the 2 topical treatments, with daily application for the first 4 weeks in the acute phase and twice weekly for next 4 weeks in the maintenance phase. The severity of disease was assessed using SCORing Atopic Dermatitis (SCORAD), and QoL was assessed using the Children's Dermatology Life Quality Index (CDLQI).
Results
At the end of the acute phase, there was a reduction in SCORAD score of 69.29% in the fluticasone group and 64.2% in the tacrolimus group (P < 0.001). In the maintenance phase, the score had risen in the fluticasone group by a mean difference of 0.81, while in the tacrolimus group it decreased by 0.99. Both fluticasone and tacrolimus groups improved in children's QoL (P < 0.001). Positive correlation (r = 0.4668) exists between SCORAD and QoL. The most common adverse skin reaction noted was skin burning with tacrolimus.
Conclusions
Fluticasone and tacrolimus are equally efficacious in the treatment of AD and have similar benefits with children's QoL. Tacrolimus is better than fluticasone at reducing the extent of lesions.",2020,Both fluticasone and tacrolimus groups improved in children's QoL (P < 0.001).,"['Thirty-seven children with AD', 'Atopic Dermatitis']","['fluticasone', 'tacrolimus', 'Fluticasone and tacrolimus', 'Topical Fluticasone Versus Tacrolimus', 'fluticasone and tacrolimus', 'Topical calcineurin inhibitors (TCI', 'Topical corticosteroids (TCS']","[""SCORing Atopic Dermatitis (SCORAD), and QoL was assessed using the Children's Dermatology Life Quality Index (CDLQI"", 'SCORAD score', 'quality of life (QoL', ""children's QoL""]","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}]",37.0,0.0751031,Both fluticasone and tacrolimus groups improved in children's QoL (P < 0.001).,"[{'ForeName': 'Vinodhini R', 'Initials': 'VR', 'LastName': 'Mudaliyar', 'Affiliation': 'Department of Pharmacology, Uttar Pradesh University of Medical Sciences, Saifai, Etawah, India.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'Department of Pharmacology, Uttar Pradesh University of Medical Sciences, Saifai, Etawah, India.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Dixit', 'Affiliation': 'Department of Pharmacology, Uttar Pradesh University of Medical Sciences, Saifai, Etawah, India.'}, {'ForeName': 'Sweta S', 'Initials': 'SS', 'LastName': 'Kumar', 'Affiliation': 'Department of Dermatology, Uttar Pradesh University of Medical Sciences, Saifai, Etawah, India.'}]",Dermatology practical & conceptual,['10.5826/dpc.1004a94']
2141,33150053,"Group Acupuncture Therapy With Yoga Therapy for Chronic Neck, Low Back, and Osteoarthritis Pain in Safety Net Setting for an Underserved Population: Design and Rationale for a Feasibility Pilot.","Chronic pain is prevalent in the United States, with impact on physical and psychological functioning as well as lost work productivity. Minority and lower socioeconomic populations have increased prevalence of chronic pain with less access to pain care, poorer outcomes, and higher risk of fatal opioid overdose. Acupuncture therapy is effective in treating chronic pain conditions including chronic low back pain, neck pain, shoulder pain, and knee pain from osteoarthritis. Acupuncture therapy, including group acupuncture, is feasible and effective, and specifically so for underserved and diverse populations at risk for health outcome disparities. Acupuncture therapy also encourages patient engagement and activation. As chronic pain improves, there is a natural progression to want and need to increase activity and movement recovery. Diverse movement approaches are important for improving range of motion, maintaining gains, strengthening, and promoting patient engagement and activation. Yoga therapy is an active therapy with proven benefit in musculoskeletal pain disorders and pain associated disability. The aim of this quasi-experimental pilot feasibility trial is to test the bundling of these 2 effective care options for chronic pain, to inform both the design for a larger randomized pragmatic effectiveness trial as well as implementation strategies across underserved settings.",2020,"Acupuncture therapy, including group acupuncture, is feasible and effective, and specifically so for underserved and diverse populations at risk for health outcome disparities.",[],"['Acupuncture Therapy With Yoga Therapy', 'Yoga therapy', 'Acupuncture therapy']","['chronic pain', 'Chronic pain']",[],"[{'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",,0.116807,"Acupuncture therapy, including group acupuncture, is feasible and effective, and specifically so for underserved and diverse populations at risk for health outcome disparities.","[{'ForeName': 'Arya', 'Initials': 'A', 'LastName': 'Nielsen', 'Affiliation': 'Department of Family Medicine and Community Health, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Teets', 'Affiliation': 'Department of Family Medicine and Community Health, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Steffany', 'Initials': 'S', 'LastName': 'Moonaz', 'Affiliation': 'Research Department, Maryland University of Integrative Medicine, Laurel, Maryland.'}, {'ForeName': 'Belinda J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': 'College of Health Professions, Pace University, New York.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Walter', 'Affiliation': 'Department of Family Medicine and Community Health, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Milanes', 'Affiliation': 'Institute for Family Health, New York.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Mah', 'Affiliation': 'Pacific College of Health and Science, San Diego, California and New York.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Diane McKee', 'Affiliation': 'Department of Family and Social Medicine, Albert Einstein College of Medicine, New York.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Kligler', 'Affiliation': 'Department of Family Medicine and Community Health, Icahn School of Medicine at Mount Sinai, New York, New York.'}]",Global advances in health and medicine,['10.1177/2164956120964716']
2142,33150280,Emergency Medicine Oral Case Presentations: Evaluation of a Novel Curriculum.,"Objectives
Oral case presentation (OCP) is recognized as a central educational and patient care activity, yet has not been well studied in the emergency medicine (EM) setting. The purpose of this study was to evaluate the effect of a novel curriculum on medical students' EM-OCP skills.
Methods
An EM-OCP assessment tool and novel blended curriculum were developed based on results from a Canadian survey of emergency physicians and focus groups with key stakeholders. We conducted a randomized controlled trial of 96 clerkship students between 2017 and 2018. Students were randomly assigned into an intervention group where they completed a novel EM-OCP curriculum or a control group without the curriculum. A pretest baseline assessment of students' OCP skills was performed using a standardized patient case at the beginning of their EM rotation. Similarly, all students completed a posttest assessment with a different standardized patient case at the end of their 6-week EM rotation. Audio recordings of pre- and posttests were assessed using the EM-OCP assessment tool by two blinded assessors.
Results
Using the Kruskal-Wallis test, all students demonstrated improvement in EM-OCP skills between their pretest and posttest; however, those who received the curriculum (intervention group) showed significantly greater improvement in ""synthesis of information,"" ""management,"" and ""overall entrustment decision"" scores.
Conclusions
Implementation of a novel EM-OCP curriculum resulted in improved clinical reasoning and higher entrustment scores. This curriculum could improve OCP performance not only in EM settings but also across specialties where medical students and residents manage critically ill patients.",2020,"Using the Kruskal-Wallis test, all students demonstrated improvement in EM-OCP skills between their pretest and posttest; however, those who received the curriculum (intervention group) showed significantly greater improvement in ""synthesis of information,"" ""management,"" and ""overall entrustment decision"" scores.
","['96 clerkship students between 2017 and 2018', 'medical students and residents manage critically ill patients']","['novel EM-OCP curriculum or a control group without the curriculum', 'EM-OCP assessment tool and novel blended curriculum', 'novel EM-OCP curriculum', 'novel curriculum']","['synthesis of information,"" ""management,"" and ""overall entrustment decision"" scores', 'OCP performance', 'EM-OCP skills', 'clinical reasoning']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}]",96.0,0.0678932,"Using the Kruskal-Wallis test, all students demonstrated improvement in EM-OCP skills between their pretest and posttest; however, those who received the curriculum (intervention group) showed significantly greater improvement in ""synthesis of information,"" ""management,"" and ""overall entrustment decision"" scores.
","[{'ForeName': 'Teresa M J', 'Initials': 'TMJ', 'LastName': 'Wawrykow', 'Affiliation': 'Department of Emergency Medicine Max Rady College of Medicine Rady Faculty of Health Sciences University of Manitoba Winnipeg Manitoba.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'McColl', 'Affiliation': 'Department of Emergency Medicine Max Rady College of Medicine Rady Faculty of Health Sciences University of Manitoba Winnipeg Manitoba.'}, {'ForeName': 'Alkarim', 'Initials': 'A', 'LastName': 'Velji', 'Affiliation': 'Department of Pediatrics and Child Health Max Rady College of Medicine Rady Faculty of Health Sciences University of Manitoba Winnipeg Manitoba Canada.'}, {'ForeName': 'Ming-Ka', 'Initials': 'MK', 'LastName': 'Chan', 'Affiliation': 'FRCPC Emergency Medicine Program University of Manitoba Winnipeg Manitoba Canada.'}]",AEM education and training,['10.1002/aet2.10408']
2143,33150320,"Safety and immunogenicity of Vi-DT conjugate vaccine among 6-23-month-old children: Phase II, randomized, dose-scheduling, observer-blind Study.","Background
Typhoid causes significant mortality among young children in resource-limited settings. Conjugate typhoid vaccines could significantly reduce typhoid-related child deaths, but only one WHO-prequalified typhoid conjugate vaccine exists for young children. To address this gap, we investigated the safety, immunogenicity and dose-scheduling of Vi-DT typhoid conjugate vaccine among children aged 6-23 months.
Methods
In this single center, observer blind, phase II trial, participants were randomly assigned (2:2:1) to receive one or two doses of Vi-DT or comparator vaccine. Anti-Vi IgG titer and geometric mean titers (GMT) were determined at 0, 4, 24 and 28 weeks. Data were analyzed using per-protocol and immunogenicity (a subset of intention-to-treat analysis) sets. The trial is registered with ClinicalTrials.gov (NCT03527355).
Findings
Between April and July 2018, 285 children were randomized; 114 received one or two doses of Vi-DT while 57 received comparator. 277 completed the study follow-up per protocol; 112 and 110 from single- and two-dose Vi-DT schedules, respectively and 55 from the placebo group were included in the per protocol analysis. Safety profile is satisfactory. Thirteen serious adverse events were reported during the 28-week follow-up, none of which were related to Vi-DT. The seroconversion rate four weeks after the first dose was 100% (95% CI 98·3-100) in Vi-DT recipients and 7·0% (95% CI 2·8-16·7) in comparator recipients (p<0·0001). Similarly, the seroconversion rate 4 weeks after the second dose was 98·2% (95% CI 93· 6-99·5) and 21·8% (95% CI 13·0-34·4) among Vi-DT and comparator groups, respectively (p<0·0001). Anti-Vi IgG GMT was significantly higher in Vi-DT than in control group at all post-vaccination visits (p<0·0001).
Interpretation
Both single and two doses of Vi-DT vaccine are safe, well tolerated, and immunogenic for infants and toddlers in a moderately endemic setting.",2020,"Anti-Vi IgG GMT was significantly higher in Vi-DT than in control group at all post-vaccination visits (p<0·0001).
","['6-23-month-old children', 'children aged 6-23 months', 'young children in resource-limited settings', 'Findings\n\n\nBetween April and July 2018', 'infants and toddlers in a moderately endemic setting', '285 children were randomized; 114 received one or two doses of']","['Vi-DT while 57 received comparator', 'Conjugate typhoid vaccines', 'Vi-DT or comparator vaccine', 'Vi-DT vaccine', 'Vi-DT typhoid conjugate vaccine', 'placebo', 'Anti-Vi', 'Vi-DT conjugate vaccine']","['Safety and immunogenicity', 'seroconversion rate', 'Thirteen serious adverse events', 'IgG titer and geometric mean titers (GMT']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0041469', 'cui_str': 'Typhoid vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0058773', 'cui_str': 'Diphtheria + tetanus vaccine'}, {'cui': 'C0041466', 'cui_str': 'Typhoid fever'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",285.0,0.709573,"Anti-Vi IgG GMT was significantly higher in Vi-DT than in control group at all post-vaccination visits (p<0·0001).
","[{'ForeName': 'Maria Rosario', 'Initials': 'MR', 'LastName': 'Capeding', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, The Philippines.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Sil', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Birkneh Tilahun', 'Initials': 'BT', 'LastName': 'Tadesse', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Saluja', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Teshome', 'Affiliation': 'CORE Group Polio Project, Ethiopia.'}, {'ForeName': 'Edison', 'Initials': 'E', 'LastName': 'Alberto', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, The Philippines.'}, {'ForeName': 'Deok Ryun', 'Initials': 'DR', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Eun Lyeong', 'Initials': 'EL', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Ju Yeon', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Yang', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Suchada', 'Initials': 'S', 'LastName': 'Chinaworapong', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jiwook', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sue-Kyoung', 'Initials': 'SK', 'LastName': 'Jo', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chon', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Seon-Young', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'SK bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Hwa', 'Initials': 'JH', 'LastName': 'Ryu', 'Affiliation': 'SK bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Inho', 'Initials': 'I', 'LastName': 'Cheong', 'Affiliation': 'SK bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Kyu-Young', 'Initials': 'KY', 'LastName': 'Shim', 'Affiliation': 'SK bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Yoonyeong', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'SK bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Hun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'SK bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Lynch', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Excler', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'T Anh', 'Initials': 'TA', 'LastName': 'Wartel', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sushant', 'Initials': 'S', 'LastName': 'Sahastrabuddhe', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100540']
2144,33150325,"Efficacy, safety and acceptability of a new chewable formulation versus the solid tablet of mebendazole against hookworm infections in children: An open-label, randomized controlled trial.","Background
Soil-transmitted helminths (STHs) infect almost 1·5 billion people worldwide. The control of STH infections is based on preventive chemotherapy using either albendazole or mebendazole. Before being widely used, a sufficient body of evidence on efficacy, safety and acceptability is warranted for the new chewable child-friendly formulation of mebendazole that was recently developed.
Methods
We conducted a randomised controlled superiority trial in four primary schools and kindergartens on Pemba Island, Tanzania. We considered eligible children aged 3 to 12 years with a hookworm infection intensity of at least 50 eggs per gram (EPG) of stool and no chronic diseases. Participants were allocated to treatment arms (ratio 1:1) using a computer generated random sequence. Our primary outcome was geometric mean based egg reduction rate (ERR) against hookworm assessed 14-21 days post-treatment. This trial complete and is registered with ClinicalTrials.gov, number NCT03995680 (June 24, 2019).
Findings
397 children were eligible and randomised into the solid (198) or chewable (199) tablet arms, of whom 393 were analysed. We found no significant difference between both formulations in terms of ERR (solid 70·8% versus chewable 68·5%, difference in ERR geometric mean 2·3%-points, 95% CI -7·8 to 12·6, p = 0.65) and CR (11·2 versus 12·7%, 95% CI -4·9 to 7·9, p = 0.65) against hookworm infections. Adverse events were mild in both treatment arms.
Interpretations
Though we could not demonstrate superiority in terms of efficacy of the new formulation, the difference between arms was small and therefore, the chewable formulation could be safely used as an alternative to swallowable tablets, in particular in young children who may have swallowing difficulties. This might help increase compliance and, consequently, enhance the effect of preventive chemotherapy.",2020,"We found no significant difference between both formulations in terms of ERR (solid 70·8% versus chewable 68·5%, difference in ERR geometric mean 2·3%-points, 95% CI -7·8 to 12·6, p = 0.65) and CR (11·2 versus 12·7%, 95% CI -4·9 to 7·9, p = 0.65) against hookworm infections.","['young children who may have swallowing difficulties', 'four primary schools and kindergartens on Pemba Island, Tanzania', 'children', '397 children were eligible and randomised into the solid (198) or chewable (199) tablet arms, of whom 393 were analysed', 'eligible children aged 3 to 12 years with a hookworm infection intensity of at least 50 eggs per gram (EPG) of stool and no chronic diseases']","['albendazole or mebendazole', 'mebendazole']","['ERR', 'efficacy, safety and acceptability', 'geometric mean based egg reduction rate (ERR) against hookworm', 'Adverse events', 'ERR geometric', 'Efficacy, safety and acceptability']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0205801', 'cui_str': 'Pemba'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0304290', 'cui_str': 'Chewable tablet'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019911', 'cui_str': 'Disease due to superfamily Ancylostomatoidea'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0025023', 'cui_str': 'Mebendazole'}]","[{'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002830', 'cui_str': 'Superfamily ancylostomatoidea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",397.0,0.3756,"We found no significant difference between both formulations in terms of ERR (solid 70·8% versus chewable 68·5%, difference in ERR geometric mean 2·3%-points, 95% CI -7·8 to 12·6, p = 0.65) and CR (11·2 versus 12·7%, 95% CI -4·9 to 7·9, p = 0.65) against hookworm infections.","[{'ForeName': 'Marta S', 'Initials': 'MS', 'LastName': 'Palmeirim', 'Affiliation': 'Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, and University of Basel, P.O. Box, CH-4002, Basel, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Bosch', 'Affiliation': 'Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, and University of Basel, P.O. Box, CH-4002, Basel, Switzerland.'}, {'ForeName': 'Shaali M', 'Initials': 'SM', 'LastName': 'Ame', 'Affiliation': 'Public Health Laboratory Ivo de Carneri, Chake, Tanzania.'}, {'ForeName': 'Said M', 'Initials': 'SM', 'LastName': 'Ali', 'Affiliation': 'Public Health Laboratory Ivo de Carneri, Chake, Tanzania.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hattendorf', 'Affiliation': 'Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute, and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Keiser', 'Affiliation': 'Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, and University of Basel, P.O. Box, CH-4002, Basel, Switzerland.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100556']
2145,33150371,The Effect of Lacrosse Protective Equipment on Cardiopulmonary Resuscitation and Automated External Defibrillator Shock.,"CONTEXT
In the event of an acute cardiac event, on-field equipment removal is suggested, although it remains unknown how lacrosse equipment removal may alter time to first chest compression and time to first AED shock.
OBJECTIVE
To determine time to first chest compression and first AED shock in 2 chest exposure procedures with 2 different pad types.
DESIGN
Crossover study Setting: Simulation laboratory Participants: Thirty-six athletic trainers (21 females, 15 males; age=30.58±7.81) Main Outcome Measures: Participants worked in pairs to provide 2 rescuer CPR intervention on a simulation manikin (QCPR manikin, Laerdal Medical, Wappingers Falls, NY) outfitted with lacrosse pads and helmet. Participants completed a total of 8 trials per pair (2 chest exposure procedures X 2 pad types X 2 participant roles). The dependent variables were time to first compression (s) and time to first AED shock (s). The independent variables were chest exposure procedure with 2 levels (procedure 1: removal of helmet while initiating CPR over the pads followed by pad retraction and AED application; procedure 2: removal of helmet and removal of pads followed by CPR and AED application) and pad type (Warrior Burn Hitman shoulder pads; Warrior Nemesis chest protector).
RESULTS
We found a statistically significant interaction between chest exposure procedure and pad type for time to first compression (F1,35=4.66, P=0.04, ω2p=0.10) with significantly faster times during procedure 1 for both the Nemesis pads (16.1±3.4 s) and the Hitman pads (16.1±4.5 s) compared to procedure 2 (Nemesis pads: 49.6±12.9 s, P<0.0001; Hitman pads: 53.8±14.5 s, P<0.0001).
CONCLUSIONS
Completing the initial cycle of chest compressions over either shoulder pads or a chest protector hastens time to first chest compression without diminishing CPR quality which may improve patient outcomes. Time to first AED shock was not different between equipment procedure or pad type.",2020,"We found a statistically significant interaction between chest exposure procedure and pad type for time to first compression (F1,35=4.66, P=0.04, ω2p=0.10) with significantly faster times during procedure 1 for both the Nemesis pads (16.1±3.4 s) and the Hitman pads (16.1±4.5 s) compared to procedure 2 (Nemesis pads:","['2 chest exposure procedures with 2 different pad types', 'Thirty-six athletic trainers (21 females, 15 males; age=30.58±7.81', 'Simulation laboratory Participants']",['Lacrosse Protective Equipment'],"['removal of helmet and removal of pads followed by CPR and AED application) and pad type (Warrior Burn Hitman shoulder pads; Warrior Nemesis chest protector', 'simulation manikin (QCPR manikin, Laerdal Medical, Wappingers Falls, NY) outfitted with lacrosse pads and helmet', 'time to first compression (s) and time to first AED shock (s']","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0022909', 'cui_str': 'Lacrosse'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C3882112', 'cui_str': 'Chest protector'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0022909', 'cui_str': 'Lacrosse'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0036974', 'cui_str': 'Shock'}]",,0.0454545,"We found a statistically significant interaction between chest exposure procedure and pad type for time to first compression (F1,35=4.66, P=0.04, ω2p=0.10) with significantly faster times during procedure 1 for both the Nemesis pads (16.1±3.4 s) and the Hitman pads (16.1±4.5 s) compared to procedure 2 (Nemesis pads:","[{'ForeName': 'Thomas Gregory', 'Initials': 'TG', 'LastName': 'Bowman', 'Affiliation': '*University of Lynchburg.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Boergers', 'Affiliation': '†Seton Hall University.'}, {'ForeName': 'Monica R', 'Initials': 'MR', 'LastName': 'Lininger', 'Affiliation': '‡Northern Arizona University.'}, {'ForeName': 'Alexander Jake', 'Initials': 'AJ', 'LastName': 'Kilmer', 'Affiliation': '*University of Lynchburg.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Ardente', 'Affiliation': '†Seton Hall University.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': ""D'Amodio"", 'Affiliation': '†Seton Hall University.'}, {'ForeName': 'Cassidy', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': '†Seton Hall University.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Murphy', 'Affiliation': '†Seton Hall University.'}]",Journal of athletic training,['10.4085/437-20']
2146,33150445,Biomechanical Response to External Biofeedback During Functional Tasks in Individuals with Chronic Ankle Instability.,"CONTEXT
Altered biomechanics displayed by individuals with chronic ankle instability (CAI) is a potential cause for recurring injuries and posttraumatic osteoarthritis. Current interventions are unable to modify aberrant biomechanics leading research efforts to determine if real-time external biofeedback is capable of producing changes.
OBJECTIVE
Determine real-time effects of visual and auditory biofeedback on functional task biomechanics in individuals with CAI Design: Crossover study Setting: Laboratory Patients or Other Participants: Nineteen physically active adults with CAI (23.95±5.52 years; 168.87±6.94 cm; 74.74±15.41 kg, female=12) volunteered.
INTERVENTION
Participants randomly performed single-leg static balance, step-downs, lateral-hops, and forward-lunges during a baseline and two biofeedback conditions. Auditory biofeedback was given through a pressure sensor placed under the lateral foot connected to a buzzer eliciting a noise when pressure exceeded the set threshold. Visual biofeedback was given through a cross-line laser secured to the dorsum of the foot. Cues given during the biofeedback conditions were used to promote proper biomechanics during each respective task.
MAIN OUTCOME MEASURE(S)
Location of center of pressure (COP) data points during balance with eyes-open and closed during each condition. Plantar pressure during functional tasks were extracted in the lateral column of the foot. Secondary outcomes of interested were COP area and velocity, time-to-boundary during static balance, and additional plantar pressure measures.
RESULTS
Both biofeedback conditions reduced COP in the anterolateral quadrant while increasing COP in the posteromedial quadrant of the foot during eyes open balance, the auditory condition produced similar changes during eyes closed trials. Auditory biofeedback increased heel pressure during step-downs, while decreasing lateral forefoot pressure-time integral during lunges. Visual biofeedback increased lateral heel pressure and increased lateral heel and midfoot pressure-time integral during hops.
CONCLUSIONS
Real-time improvements in balance strategies were observed during both external biofeedback conditions. Visual and auditory biofeedback appear to effectively moderate different functional task biomechanics.",2020,"Visual biofeedback increased lateral heel pressure and increased lateral heel and midfoot pressure-time integral during hops.
","['individuals with CAI Design', 'Crossover study Setting: Laboratory Patients or Other Participants', 'individuals with chronic ankle instability (CAI', 'Nineteen physically active adults with CAI (23.95±5.52 years; 168.87±6.94 cm; 74.74±15.41 kg, female=12) volunteered', 'Individuals with Chronic Ankle Instability']","['Visual and auditory biofeedback', 'visual and auditory biofeedback', 'External Biofeedback', 'Auditory biofeedback', 'Visual biofeedback', 'single-leg static balance, step-downs, lateral-hops, and forward-lunges during a baseline and two biofeedback conditions']","['lateral forefoot pressure-time integral', 'COP area and velocity, time-to-boundary during static balance, and additional plantar pressure measures', 'functional task biomechanics', 'lateral heel pressure and increased lateral heel and midfoot pressure-time integral during hops', 'Plantar pressure', 'Location of center of pressure (COP) data points during balance with eyes-open and closed during each condition', 'heel pressure', 'balance strategies']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0932074', 'cui_str': 'Midfoot region of foot'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",19.0,0.0293757,"Visual biofeedback increased lateral heel pressure and increased lateral heel and midfoot pressure-time integral during hops.
","[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Torp', 'Affiliation': 'University of North Carolina at Charlotte.'}, {'ForeName': 'Abbey C', 'Initials': 'AC', 'LastName': 'Thomas', 'Affiliation': 'University of North Carolina at Charlotte.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Hubbard-Turner', 'Affiliation': 'University of North Carolina at Charlotte.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Donovan', 'Affiliation': 'University of North Carolina at Charlotte.'}]",Journal of athletic training,['10.4085/197-20']
2147,33150497,"Rivaroxaban Versus Warfarin in Patients with Mechanical Heart Valves: Open-Label, Proof-of-Concept trial-The RIWA study.","BACKGROUND AND PURPOSE
To date, vitamin K antagonists are the only available oral anticoagulants in patients with mechanical heart valves. In this way, we developed a pilot trial with rivaroxaban.
METHODS
The RIWA study was a proof-of-concept, open-label, randomized clinical trial and was designed to assess the incidence of thromboembolic and bleeding events of the rivaroxaban-based strategy (15 mg twice daily) in comparison to dose-adjusted warfarin. Patients were randomly assigned in a 1:1 ratio and were followed prospectively for 90 days.
RESULTS
A total of 72 patients were enrolled in the present study. Of these, 44 patients were randomized: 23 patients were allocated to the rivaroxaban group and 21 to the warfarin group. After 90 days of follow-up, the primary outcome occurred in one patient (4.3%) in the rivaroxaban group and three patients (14.3%) in the warfarin group (risk ratio [RR] 0.27; 95% confidence interval [CI] 0.02-2.85; P = 0.25). Minor bleeding (without discontinuation of medical therapy) occurred in six patients (26.1%) in the rivaroxaban group versus six patients (28.6%) in the warfarin group (RR 0.88; 95% CI 0.23-3.32; P = 0.85). One patient in the warfarin group died from myocardial infarction. No cases of hemorrhagic stroke, valve thrombosis, peripheral embolic events, or new intracardiac thrombus were related in both groups.
CONCLUSIONS
In this pilot study, rivaroxaban 15 mg twice daily had thromboembolic and bleeding events similar to warfarin in patients with mechanical heart valves. These data confirm the authors' proof-of-concept and suggest that a larger trial with a similar design is not unreasonable. CLINICALTRIAL.
GOV IDENTIFIER
NCT03566303.",2020,"No cases of hemorrhagic stroke, valve thrombosis, peripheral embolic events, or new intracardiac thrombus were related in both groups.
","['Patients with Mechanical Heart Valves', '44 patients were randomized: 23 patients', 'patients with mechanical heart valves', 'A total of 72 patients were enrolled in the present study']","['rivaroxaban', 'warfarin', 'Rivaroxaban Versus Warfarin', 'rivaroxaban-based strategy', 'vitamin K antagonists']","['myocardial infarction', 'thromboembolic and bleeding events', 'hemorrhagic stroke, valve thrombosis, peripheral embolic events, or new intracardiac thrombus', 'Minor bleeding', 'incidence of thromboembolic and bleeding events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018829', 'cui_str': 'Prosthetic heart'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0876998', 'cui_str': 'Thrombus of cardiac chamber'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",72.0,0.0979232,"No cases of hemorrhagic stroke, valve thrombosis, peripheral embolic events, or new intracardiac thrombus were related in both groups.
","[{'ForeName': 'Andre Rodrigues', 'Initials': 'AR', 'LastName': 'Duraes', 'Affiliation': 'PPGMS/Federal University of Bahia, UFBA, Bahia, Salvador, Brazil. andreduraes@gmail.com.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'de Souza Lima Bitar', 'Affiliation': 'Medical School, Federal University of Bahia, FAMEB/UFBA, Largo do Terreiro de Jesus, XV de Novembro Square, s/n, Salvador, Bahia, CEP 40026-010, Brazil.'}, {'ForeName': 'Igor Santos', 'Initials': 'IS', 'LastName': 'Schonhofen', 'Affiliation': 'General Hospital Roberto Santos/SUS-Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Kethyren Santos Oliveira', 'Initials': 'KSO', 'LastName': 'Travassos', 'Affiliation': 'Bahiana School of Medicine and Public Health, EBMSP, Salvador, Bahia, Brazil.'}, {'ForeName': 'Larissa Vitória', 'Initials': 'LV', 'LastName': 'Pereira', 'Affiliation': 'Nursing School, Federal University of Bahia, UFBA, Salvador, Bahia, Brazil.'}, {'ForeName': 'Jose Admirço Lima', 'Initials': 'JAL', 'LastName': 'Filho', 'Affiliation': 'General Hospital Roberto Santos/SUS-Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Mansueto Gomes', 'Initials': 'MG', 'LastName': 'Neto', 'Affiliation': 'PPGMS/Federal University of Bahia, UFBA, Bahia, Salvador, Brazil.'}, {'ForeName': 'Roque Aras', 'Initials': 'RA', 'LastName': 'Junior', 'Affiliation': 'PPGMS/Federal University of Bahia, UFBA, Bahia, Salvador, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Federal University of Uberlândia, Minas Gerais, Uberlândia, Minas Gerais, Brazil.'}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-020-00449-3']
2148,33150514,Does anodal trans-cranial direct current stimulation of the damaged primary motor cortex affects wrist flexor muscle spasticity and also activity of the wrist flexor and extensor muscles in patients with stroke?: a Randomized Clinical Trial.,"Spasticity is a common symptom in stroke survivors. This study is double-blinded, sham-controlled randomized, clinical trial with three parallel arms. The aim of the study was to investigate the effects of anodal trans-cranial direct current stimulation (a-tDCS) over the damaged primary motor cortex (M1) on spasticity of the wrist flexor and also the activity of wrist flexor and extensor muscles in sub-acute stroke patients. This study was performed on 32 stroke patients. The patients are assigned to three groups (intervention, sham, and control). All participants in the first two groups received 20-min concurrent M1 a-tDCS or sham tDCS and functional electrical stimulation (FES) for 10 sessions (5 sessions per week), while participants in control group were given only 20-min FES for 10 sessions. Modified Ashworth scale of wrist flexors and also electromyography (EMG) activity of flexor carpi radialis (FCR) and extensor carpi radialis (ECR) were recorded before, immediately, and 1 month after the interventions. A significant reduction was shown in the MAS and EMG activity of FCR muscle at passive rest position of the wrist, immediately and 1 month after the intervention in M1 a-tDCS compared to sham and control groups (p < 0.001). Also, the EMG activity of FCR and ECR muscles during active wrist flexion and extension increased immediately and 1 month after intervention in M1 a-tDCS compared to the other groups, respectively (p < 0.001). M1 a-tDCS can significantly decrease the spasticity of wrist flexor muscle and also increase the wrist flexor and extensor muscles activity in stroke patients during active flexion and extension.",2020,"Also, the EMG activity of FCR and ECR muscles during active wrist flexion and extension increased immediately and 1 month after intervention in M1 a-tDCS compared to the other groups, respectively (p < 0.001).","['sub-acute stroke patients', 'patients with stroke', '32 stroke patients']","['20-min concurrent M1 a-tDCS or sham tDCS and functional electrical stimulation (FES', 'anodal trans-cranial direct current stimulation (a-tDCS']","['EMG activity of FCR and ECR muscles during active wrist flexion and extension', 'MAS and EMG activity of FCR muscle', 'wrist flexor and extensor muscles activity', 'Modified Ashworth scale of wrist flexors and also electromyography (EMG) activity of flexor carpi radialis (FCR) and extensor carpi radialis (ECR', 'spasticity of wrist flexor muscle']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}]",32.0,0.043072,"Also, the EMG activity of FCR and ECR muscles during active wrist flexion and extension increased immediately and 1 month after intervention in M1 a-tDCS compared to the other groups, respectively (p < 0.001).","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Halakoo', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ehsani', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran. f.ehsani@semums.ac.ir.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Masoudian', 'Affiliation': 'Neurology Ward, Department of Internal Medicine, School of Medicine, Kosar Hospital, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zoghi', 'Affiliation': 'Discipline of Physiotherapy, Department of Rehabilitation, Nutrition and Sport, School of Allied Health, La Trobe University, Bundoora, Victoria, 3086, Australia.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Department of Physiotherapy, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-020-04858-9']
2149,33154792,Shear force comparative evaluation for surface treated and non- treated 3D interim printed materials with different types of glass-ionomer cements.,"Background
The purpose of this investigation was to compare shear force of different glass-ionomer cements on 3D printed interim material in combination with and without surface pretreatment.
Material and Methods
120 rectangular specimens made of printable provisional material (Bego, Bremen, Germany) were used. After post-processing the specimens were blasted with aluminum oxide 110µm (Bego, Bremen, Germany). Extra 120 non-surface treated specimens were used as an experimental negative test group. All 240 specimens were divided randomly into 6 groups. All were cemented with a compressive load of 20 N using universal testing machine Z010 (Zwick/Roell, Ulm, Germany) to ensure a comparable cementing process. Each of the six groups were cemented with different cements (CX Plus (Shofu, Ratingen, Germany), Vivaglass CEM PL (Ivoclar Vivadent AG, Schaan, Liechtenstein), Aqua Cem (Dentsply Sirona, Bensheim, Germany), Ketac Cem (3M, Neuss, Germany), Meron Plus AC (Voco, Cuxhaven, Germany), and Fuji 1 (GC, Tokyo, Japan). Shear force test was performed, and forces were statistically analyzed via Anova test (significance level p <0.001).
Results
All the pre-treated specimens showed a significantly higher bonding strength compared to not pretreated. Meron Plus AC showed the highest shear overall force. The Anova test showed a significant difference between all pretreated study groups ( p <0.001).
Conclusions
An increase of the necessary forces for all groups was shown in pretreated group. Within the limitations of this study, a surface pretreatment is recommended when bonding a 3D interim material with glass ionomer cements. Key words: Shear force, 3D printing, glass ionomer cement, mechanical evaluation, CAD/CAM. .",2020,All the pre-treated specimens showed a significantly higher bonding strength compared to not pretreated.,['All 240 specimens'],"['Aqua Cem ', 'cements (CX Plus (Shofu, Ratingen, Germany), Vivaglass CEM PL (Ivoclar Vivadent AG, Schaan, Liechtenstein']","['Dentsply Sirona, Bensheim, Germany), Ketac Cem (3M, Neuss, Germany), Meron Plus AC (Voco, Cuxhaven, Germany), and Fuji 1 (GC, Tokyo, Japan', 'Shear force, 3D printing, glass ionomer cement, mechanical evaluation, CAD/CAM.\u2003', 'highest shear overall force', 'bonding strength']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0103918', 'cui_str': 'Aqua-cem'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C1565433', 'cui_str': 'CX-Plus'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0767537', 'cui_str': 'Vivaglass Cem'}, {'cui': 'C0124269', 'cui_str': 'Ivoclar'}, {'cui': 'C0148539', 'cui_str': 'Vivadent'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}]","[{'cui': 'C0112984', 'cui_str': 'Dentsply'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0064300', 'cui_str': 'Ketac-cem'}, {'cui': 'C1505728', 'cui_str': 'Meron'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C3849992', 'cui_str': 'Three-Dimensional Printing'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",240.0,0.0211449,All the pre-treated specimens showed a significantly higher bonding strength compared to not pretreated.,"[{'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Latz', 'Affiliation': 'Center of digital dentistry and CAD/CAM technology - Danube Private University- Krems- Austria.'}, {'ForeName': 'Constantin', 'Initials': 'C', 'LastName': 'von See', 'Affiliation': 'Prof. Dr. Center of digital dentistry and CAD/CAM technology - Danube Private University- Krems- Austria.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Alevizakos', 'Affiliation': 'Dr. med. Dent. Center of digital dentistry and CAD/CAM technology - Danube Private University- Krems- Austria.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Sandmair', 'Affiliation': 'Center of digital dentistry and CAD/CAM technology - Danube Private University- Krems- Austria.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Othman', 'Affiliation': 'Dr. Center of digital dentistry and CAD/CAM technology - Danube Private University- Krems- Austria.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.57003']
2150,33154793,Tomographic evaluation of dentoskeletal effects of rapid maxillary expansion using Haas and Hyrax palatal expanders in children: A randomized clinical trial.,"Background
Rapid maxillary expansion (RME) is a usual procedure for correcting the transversal maxillary deficiency. Among the most used appliances are the Haas type (tooth-tissue-borne) and Hyrax (tooth-borne) whose main difference is the design. This study aimed to evaluate the dentoskeletal effects of RME using two different expanders in children.
Material and Methods
The sample was composed of 42 children of both gender presenting unilateral or bilateral posterior crossbite with mean age 9.49 (SD± 1.35). Patients were randomized into two groups according to the type of expander: Hyrax (n= 21, 9 boys and 12 girls) and Haas (n= 21, 11 boys and 10 girls). Multiplanar coronal and axial slices obtained from cone-beam computed tomography images (i-Cat, Hartsfield, PA, USA) were used at pretreatment (T1) and after 6 months when the expander was removed (T2). Measurements were performed on Dolphin Imaging Systems 11.7 software (Chatsworth, California, USA). The following variables were evaluated: inclinations of the posterior teeth, transverse skeletal widths, length of maxillary dental arch, buccal bone thickness and level of buccal alveolar crest. Statistical analysis performed using chi-squared test to compare the sex ratios between groups and independent t test with the Bonferroni correction for multiple tests.
Results
RME increased all maxillary transverse dimensions, regardless of the type of expanders used. Subjects in the Hyrax group experienced significantly increase in the lingual bone thickness (0.94 mm) compare to Haas group (0.21 mm).
Conclusions
The Hyrax-type expander produced greater increase in the lingual bone thickness than did the Haas-type expander, but this effect might not be clinically significant. Both appliances presented similar transversal gain and tended to produce similar orthopedic and orthodontic effects. Key words: Cone-beam computed tomography, palatal expansion technique, palate.",2020,"Subjects in the Hyrax group experienced significantly increase in the lingual bone thickness (0.94 mm) compare to Haas group (0.21 mm).
","['children', 'n= 21, 9 boys and 12 girls) and Haas (n= 21, 11 boys and 10 girls', '42 children of both gender presenting unilateral or bilateral posterior crossbite with mean age 9.49 (SD± 1.35']","['Key words: Cone-beam computed tomography, palatal expansion technique, palate', 'rapid maxillary expansion using Haas and Hyrax palatal expanders', '\n\n\nRapid maxillary expansion (RME', 'expander: Hyrax', 'RME']","['transversal gain', 'lingual bone thickness', 'maxillary transverse dimensions', 'inclinations of the posterior teeth, transverse skeletal widths, length of maxillary dental arch, buccal bone thickness and level of buccal alveolar crest']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0264088', 'cui_str': 'Juvenile osteochondrosis of head of humerus'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C4708452', 'cui_str': 'Bilateral posterior crossbite'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0030212', 'cui_str': 'Palatal Expansion Technic'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}, {'cui': 'C0264088', 'cui_str': 'Juvenile osteochondrosis of head of humerus'}, {'cui': 'C0020696', 'cui_str': 'Family Procaviidae'}]","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0020417', 'cui_str': 'Hyoid bone structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0011325', 'cui_str': 'Dental arch structure'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}]",42.0,0.0714304,"Subjects in the Hyrax group experienced significantly increase in the lingual bone thickness (0.94 mm) compare to Haas group (0.21 mm).
","[{'ForeName': 'Marília-Carolina', 'Initials': 'MC', 'LastName': 'Araújo', 'Affiliation': 'D.D.S., M.Sc. UNOPAR - University of North Paraná, Brazil.'}, {'ForeName': 'Jéssica-Rico', 'Initials': 'JR', 'LastName': 'Bocato', 'Affiliation': 'D.D.S., M.Sc. UNOPAR - University of North Paraná, Brazil.'}, {'ForeName': 'Paula-Vanessa-Pedron', 'Initials': 'PV', 'LastName': 'Oltramari', 'Affiliation': 'D.D.S., M.Sc. PhD. Assistant Professor, Department of Orthodontics, UNOPAR - University of North Paraná, Brazil.'}, {'ForeName': 'Marcio-Rodrigues', 'Initials': 'MR', 'LastName': 'de Almeida', 'Affiliation': 'D.D.S., M.Sc. PhD. Assistant Professor, Department of Orthodontics, UNOPAR - University of North Paraná, Brazil.'}, {'ForeName': 'Ana-Cláudia-de Castro-Ferreira', 'Initials': 'AC', 'LastName': 'Conti', 'Affiliation': 'D.D.S., M.Sc. PhD. Assistant Professor, Department of Orthodontics, UNOPAR - University of North Paraná, Brazil.'}, {'ForeName': 'Thais-Maria-Freire', 'Initials': 'TM', 'LastName': 'Fernandes', 'Affiliation': 'D.D.S., M.Sc. PhD. Assistant Professor, Department of Orthodontics, UNOPAR - University of North Paraná, Brazil.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.57277']
2151,33154828,Fascia Suture Technique Is a Simple Approach to Reduce Postmastectomy Seroma Formation.,"Purpose
Seroma formation is a common complication in breast cancer patients undergoing mastectomy, and it negatively affects patient recovery after surgery. The present study aimed to evaluate a simple method using fascia suture technique to fix the flap and reduce the incidence of seroma.
Methods
A single-center, prospective, randomized controlled trial was carried out among 160 patients who had undergone mastectomy from May 2018 to September 2019. All patients were randomly divided into the fascia suture group (n = 80) or control group (n = 80) and were followed up for at least 3 months for the assessment of immediate and late complications after surgery.
Results
No significant differences were observed between the 2 groups with regard to the basic characteristics. Duration of surgery in the fascia suture group was longer by about 6 minutes compared with that in the control group (114.93 ± 13.67 minutes vs. 108.81 ± 15.20 minutes, p = 0.008). The fascia suture group had a shorter duration of drain placement (10.99 ± 3.26 days vs. 13.85 ± 5.37 days, p < 0.001), a smaller volume of the total drainage (460.95 ± 242.92 mL vs. 574.83 ± 285.23 mL, p = 0.007), and the first 3-day drainage (224.96 ± 101.01 mL vs. 272.3 ± 115.47 mL, p = 0.006), compared with the control group. The incidence of seroma formation (G2 or G3) was significantly lower in the fascia suture group compared with the control group (28.8% vs. 12.5%, p = 0.033). Besides, there was no statistical difference between the 2 groups in the assessment of other complications, including postoperative pain, hematoma, surgical site infections, flap necrosis, and skin dimpling (all p > 0.050).
Conclusion
The fascia suture technique is a simple and effective method for reducing seroma formation and should be used to prevent seroma formation after mastectomy.
Trial Registration
Chinese Clinical Trials Registry Identifier: ChiCTR1800015913.",2020,"Besides, there was no statistical difference between the 2 groups in the assessment of other complications, including postoperative pain, hematoma, surgical site infections, flap necrosis, and skin dimpling (all p > 0.050).
","['breast cancer patients undergoing mastectomy', '160 patients who had undergone mastectomy from May 2018 to September 2019']","['fascia suture group', 'Fascia Suture Technique']","['Duration of surgery', 'incidence of seroma formation (G2 or G3', 'postoperative pain, hematoma, surgical site infections, flap necrosis, and skin dimpling', 'incidence of seroma', 'smaller volume of the total drainage', 'shorter duration of drain placement']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038968', 'cui_str': 'Suturing techniques'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C4075512', 'cui_str': 'Flap necrosis'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C3495845', 'cui_str': 'Drain placement'}]",160.0,0.0481951,"Besides, there was no statistical difference between the 2 groups in the assessment of other complications, including postoperative pain, hematoma, surgical site infections, flap necrosis, and skin dimpling (all p > 0.050).
","[{'ForeName': 'Yizi', 'Initials': 'Y', 'LastName': 'Cong', 'Affiliation': 'Department of Breast Surgery, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, China.'}, {'ForeName': 'Jianqiao', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Breast Surgery, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, China.'}, {'ForeName': 'Guangdong', 'Initials': 'G', 'LastName': 'Qiao', 'Affiliation': 'Department of Breast Surgery, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Breast Surgery, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, China.'}, {'ForeName': 'Xinjie', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Surgery Department of West Area, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'Department of Breast Surgery, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, China.'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Zou', 'Affiliation': 'Department of Breast Surgery, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, China.'}, {'ForeName': 'Shiguang', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Department of Breast Surgery, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, China.'}]",Journal of breast cancer,['10.4048/jbc.2020.23.e51']
2152,33154840,Comparative Study of Intravenous Dexmedetomidine Sedation With Perineural Dexmedetomidine on Supraclavicular Approach Brachial Plexus Block in Upper Limb Orthopaedic Surgery.,"Background Dexmedetomidine is being used as an adjuvant analgesic, both as intravenous (IV) and intrathecal infusion. The role of perineural (P) dexmedetomidine has evoked attention recently. The aim of this study was to compare the effect of IV dexmedetomidine and P dexmedetomidine as an adjunct to supraclavicular brachial plexus block in upper limb orthopaedic surgery. Methods Patients were randomly divided into two equal groups (n=20). Group I (IV dexmedetomidine) received dexmedetomidine 1 mcg/kg IV as loading dose over 10 minutes, followed by continuous infusion of dexmedetomidine 0.4 mcg/kg/hr IV. Group P (P dexmedetomidine) received dexmedetomidine at 1 mcg/kg perineurally. After adequate motor response with the aid of peripheral nerve stimulator a supraclavicular block with 40 ml solution containing 5 mg/kg lignocaine (2%) with adrenaline (1:200,000) and 2 mg/kg of bupivacaine (0.5%) was injected to both the groups. Group P also received dexmedetomidine perineurally with block. Onset and duration of sensory and motor block, Ramsay sedation score, hemodynamic parameters, and postoperative analgesia requirement were assessed along with side effects. The data obtained were recorded as mean ± SD, ranges, numbers, and ratios. Results were analyzed using the chi-square test, the Mann-Whitney test for non-parametric data, and an unpaired 't'-test for parametric data. Statistical analysis was carried out using the SPSS (version 10, 2002; SPSS Inc., Chicago, IL, USA) for Windows statistical package. P value less than 0.05 was considered statistically significant. Results Mean onset of sensory block was earlier in group I than in group P (p<0.05) although mean onset of motor block was not significantly different (p>0.05). Duration of sensory and motor blockade was longer in group I (p<0.05). Patients in group I demonstrated lower pulse rate and lower systolic and diastolic blood pressures throughout the period with comparable SpO 2 values. There was no difference in intraoperative Ramsay sedation scores in both groups, but postoperative Ramsay sedation scores at 9, 12, and 15 hours were better in group I (p<0.05). The average time to rescue analgesia (visual analogue scale >4) was higher in group I (p>0.05). Conclusion IV dexmedetomidine produced early onset of sensory block, longer duration of sensory and motor block, and longer duration of analgesia as compared with P dexmedetomidine as an adjuvant to supraclavicular block with 5 mg/kg lignocaine (2%) and 2 mg/kg bupivacaine (0.5%) in upper limb orthopaedic surgeries.",2020,Patients in group I demonstrated lower pulse rate and lower systolic and diastolic blood pressures throughout the period with comparable SpO 2 values.,['Upper Limb Orthopaedic Surgery'],"['lignocaine', 'bupivacaine', 'P dexmedetomidine', 'perineural (P) dexmedetomidine', 'adrenaline', ' Dexmedetomidine', 'Dexmedetomidine Sedation With Perineural Dexmedetomidine', 'dexmedetomidine and P dexmedetomidine', 'dexmedetomidine']","['Supraclavicular Approach Brachial Plexus Block', 'postoperative Ramsay sedation scores', 'average time to rescue analgesia (visual analogue scale >4', 'intraoperative Ramsay sedation scores', 'lower pulse rate and lower systolic and diastolic blood pressures', 'early onset of sensory block,\xa0longer duration of sensory and motor block, and longer duration of analgesia', 'Onset and duration of sensory and\xa0motor block, Ramsay sedation score, hemodynamic parameters, and postoperative analgesia requirement', 'Mean onset of sensory block', 'mean onset of motor block', 'Duration of sensory and motor blockade']","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]",,0.0753175,Patients in group I demonstrated lower pulse rate and lower systolic and diastolic blood pressures throughout the period with comparable SpO 2 values.,"[{'ForeName': 'Priyank', 'Initials': 'P', 'LastName': 'Samar', 'Affiliation': 'Anesthesiology, K.J. Somaiya Medical College and Hospital, Mumbai, IND.'}, {'ForeName': 'Tanvi A', 'Initials': 'TA', 'LastName': 'Dhawale', 'Affiliation': 'Anesthesiology, K.J. Somaiya Medical College and Hospital, Mumbai, IND.'}, {'ForeName': 'Sarla', 'Initials': 'S', 'LastName': 'Pandya', 'Affiliation': 'Anesthesiology, K.J. Somaiya Medical College and Hospital, Mumbai, IND.'}]",Cureus,['10.7759/cureus.10768']
2153,33154872,"Autologous Fat Transfer for Scar Prevention and Remodeling: A Randomized, Blinded, Placebo-controlled Trial.","Autologous fat transfer-also referred to as fat grafting-has been reported to provide beneficial effects to overlying scar and skin. Despite procedural frequency, there is a paucity of high-level evidence guiding the surgeon in technique, patient selection, and efficacy.
Methods
A multicenter, double-blinded, randomized, internally placebo-controlled trial was performed with an aim to qualitatively and quantitatively evaluate the impact of autologous fat transfer on the quality of overlying scar tissue. Fat-grafted scars were evaluated and compared with paired, saline-injected ""control"" scars. Subjective and objective metrics were evaluated in treated sites for 12 months after treatment.
Results
Blinded qualitative results demonstrated a statistically significant improvement in scar quality over time in fat-grafted scars. However, these improvements were not found to be statistically different from changes noted in scars treated with saline. In addition, objective metrics did not statistically differ between saline-injected and autologous fat-grafted scars.
Conclusions
Our results demonstrate that autologous fat grafting can improve the qualitative profile of a scar from both the patient and observer perspectives. However, there was no difference in improvement when compared with scars that were treated with saline in a randomized and blinded fashion. These results demonstrate that any improvements in scar quality related to fat grafting are also achieved using saline and suggest that mechanisms other than cell activity may be at play. Additional randomized, blinded, placebo-controlled trials are required to either corroborate or contest the putative beneficial effect(s) of adipose tissue on scar remodeling.",2020,"However, these improvements were not found to be statistically different from changes noted in scars treated with saline.",[],"['autologous fat transfer', 'saline', 'placebo', 'Autologous Fat Transfer', 'Placebo']","['scar quality', 'Subjective and objective metrics', 'quality of overlying scar tissue']",[],"[{'cui': 'C4076692', 'cui_str': 'Autologous fat'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0241158', 'cui_str': 'Scar of skin'}]",,0.369985,"However, these improvements were not found to be statistically different from changes noted in scars treated with saline.","[{'ForeName': 'J Christian', 'Initials': 'JC', 'LastName': 'Brown', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, Fla.'}, {'ForeName': 'Hulan', 'Initials': 'H', 'LastName': 'Shang', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, Fla.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, Fla.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Pierson', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, Fla.'}, {'ForeName': 'Catherine R', 'Initials': 'CR', 'LastName': 'Ratliff', 'Affiliation': 'Department of Plastic Surgery, University of Virginia Health System, Charlottesville, Va.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Prince', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, Fla.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Roney', 'Affiliation': 'Department of Plastic Surgery, Loma Linda University, Loma Linda, Calif.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Chan', 'Affiliation': 'United States Army Institute of Surgical Research, Fort Sam, Houston, Tex.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hatem', 'Affiliation': 'United States Army Institute of Surgical Research, Fort Sam, Houston, Tex.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Gittleman', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Jill S', 'Initials': 'JS', 'LastName': 'Barnholtz-Sloan', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Vincek', 'Affiliation': 'Department of Dermatology, University of Florida, Gainesville, Fla.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Katz', 'Affiliation': 'Department of Surgery, University of Florida, Gainesville, Fla.'}]",Plastic and reconstructive surgery. Global open,['10.1097/GOX.0000000000002830']
2154,33154892,Comparison between two protocols for deflation of the TR band following coronary procedures via the radial route.,"Aim
Coronary interventions are increasingly being performed via the radial rather than femoral route because of the lower complication rate. Compression devices such as the TR band are used to achieve hemostasis after the procedure. At present, there are no clear protocols for the deflation of the band. In this study we compared two protocols (early deflation with increased intervals vs. late deflation with smaller intervals) in terms of total time to band removal and complications, and patient and staff satisfaction.
Methods
All patients who underwent a transradial coronary procedure and had a TR band fitted were enrolled into the study. The TR band was applied using the patent hemostasis method (2 ml air pushed in after the radial pulse appears on pulse oximetry after full occlusion with 16 ml air). Patients were randomly assigned to either protocol. Protocol 1 involved removal of 2 ml of air starting 1 hour after the sheath removal and then removal of 2 ml every 30 minutes until the band came off. Protocol 2 involved removal of 4 ml of air 2 hours after the sheath removal and then further 4 ml of air every 15 minutes until the band came off. Patient and staff satisfaction was measured with a visual analogue scale.
Results
A total of 174 patients were recruited (mean age, 60 ± 11 years; 127 male, 47 female). The baseline characteristics including total heparin dose and type of procedure, in the two arms were the same. Protocol 2 ( n = 84) was associated with a significantly lower time to TR band removal as compared to protocol 1 ( n = 90; 201 ± 43 min vs. 274 ± 54 min; p < 0.001). There was no difference in complications such as bleeding or hematoma formation between the two groups. Patient satisfaction was the same between the two groups. However, the staff preferred protocol 1 ( p = 0.01).
Conclusion
A protocol of delayed initiation of TR band deflation followed by quick deflations is associated with a lower time to band removal with no increase in bleeding complications or patient satisfaction. However, the staff preferred longer intervals between deflations.",2020,Protocol 2 ( n = 84) was associated with a significantly lower time to TR band removal as compared to protocol 1 ( n = 90; 201 ± 43 min vs. 274 ± 54 min; p < 0.001).,"['All patients who underwent a transradial coronary procedure and had a TR band fitted were enrolled into the study', '174 patients were recruited (mean age, 60 ± 11 years; 127 male, 47 female']",[],"['Patient satisfaction', 'visual analogue scale', 'Patient and staff satisfaction', 'total time to band removal and complications, and patient and staff satisfaction', 'bleeding complications', 'complications such as bleeding or hematoma formation', 'time to TR band removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",174.0,0.0418828,Protocol 2 ( n = 84) was associated with a significantly lower time to TR band removal as compared to protocol 1 ( n = 90; 201 ± 43 min vs. 274 ± 54 min; p < 0.001).,"[{'ForeName': 'Hassan Al', 'Initials': 'HA', 'LastName': 'Riyami', 'Affiliation': 'Department of Cardiology, Sultan Qaboos University Hospital, Alkhod, Muscat, Oman.'}, {'ForeName': 'Adil Al', 'Initials': 'AA', 'LastName': 'Riyami', 'Affiliation': 'Department of Cardiology, Sultan Qaboos University Hospital, Alkhod, Muscat, Oman.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Nadar', 'Affiliation': 'Department of Cardiology, Sultan Qaboos University Hospital, Alkhod, Muscat, Oman.'}]",Journal of the Saudi Heart Association,['10.37616/2212-5043.1009']
2155,33154911,Comparison of the effects of ticagrelor and clopidogrel on heart rate variability and heart rate turbulence in patients with percutaneous coronary interventions.,"Introduction
Clopidogrel and ticagrelor are commonly used, antiplatelet agents. Ticagrelor has an effect of enhancing the plasma level of adenosine that may alter the autonomic function. The aim of this study is to compare the effects of ticagrelor and clopidogrel on heart rate variability (HRV) and heart rate turbulence (HRT).
Methods
Thirty subjects who performed percutaneous coronary intervention (PCI) were included in the randomized, crossover study. These patients were divided into two groups. Clopidogrel or ticagrelor was administered in two different testing sessions (1-month treatment for each session). In group 1, clopidogrel and ticagrelor treatment were used while in group 2, ticagrelor and clopidogrel treatment were used respectively. Three times rhythm Holter recording (baseline, 1st and 2nd month) was performed. The HRV (time domain and frequency domain) and HRT (turbulence onset (TO) and turbulence slope (TS)) parameters were analyzed from the Holter recordings.
Results
According to baseline Holter recording, pNN50 (5.82 ± 5.83 vs 10.56 ± 8.28; p = 0.03) and HF(nu) (6.85 ± 9.33 vs 9.53 ± 7.41; p = 0.04) parameters were higher in group 2 than in group 1, while TO(0.004 ± 0.02 vs -0.01 ± 0.02; p = 0.01) parameter was positive and higher in group 1 than in group 2. In the second month, the LF/HF ratio (4.47 ± 2.43 vs 3.18 ± 2.45; p = 0.04) was higher in group 1 than in group 2. However, when the evaluation was done within the groups themselves, there were no statistically significant differences in HRV and HRT parameters obtained before and after clopidogrel and ticagrelor administration in group 1 and group 2.
Conclusion
Ticagrelor and clopidogrel treatments did not have a significant effect on HRV and HRT parameters.",2020,"However, when the evaluation was done within the groups themselves, there were no statistically significant differences in HRV and HRT parameters obtained before and after clopidogrel and ticagrelor administration in group 1 and group 2.
","['patients with percutaneous coronary interventions', 'Thirty subjects who performed percutaneous coronary intervention (PCI']","['Clopidogrel and ticagrelor', 'Ticagrelor', 'clopidogrel and ticagrelor', 'Clopidogrel or ticagrelor', 'ticagrelor', 'ticagrelor and clopidogrel']","['heart rate variability (HRV) and heart rate turbulence (HRT', 'HRV and HRT parameters', 'heart rate variability and heart rate turbulence', 'HRV (time domain and frequency domain) and HRT (turbulence onset (TO) and turbulence slope (TS)) parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",30.0,0.0226561,"However, when the evaluation was done within the groups themselves, there were no statistically significant differences in HRV and HRT parameters obtained before and after clopidogrel and ticagrelor administration in group 1 and group 2.
","[{'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Yagcioglu', 'Affiliation': 'Bursa Postgraduate Hospital, Departments of Cardiology, Bursa, Turkey.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Ari', 'Affiliation': 'Bursa Postgraduate Hospital, Departments of Cardiology, Bursa, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Ari', 'Affiliation': 'Bursa Postgraduate Hospital, Departments of Cardiology, Bursa, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Melek', 'Affiliation': 'Bursa Postgraduate Hospital, Departments of Cardiology, Bursa, Turkey.'}]",Journal of the Saudi Heart Association,['10.37616/2212-5043.1048']
2156,33154991,Regression to the Mean: A Statistical Phenomenon of Worthy Consideration in Anemia Research.,"Background
Regression to the mean (RTM) is a statistical phenomenon where second measurements are more likely to be closer to the mean. This is particularly observed in those with baseline values further from the mean. Anemic individuals (hemoglobin <120 g/L) are often recruited when evaluating iron supplementation programs, as they are more likely to elicit a greater hemoglobin response; however, they are also at greater risk for RTM as their baseline values are lower than the overall population mean.
Objective
The aim was to calculate and apply RTM to a previously conducted iron supplementation trial of women in Cambodia at increasingly severe baseline anemia cutoffs (hemoglobin <120 g/L, <115 g/L, and <110 g/L).
Methods
Women received either 60 mg/d iron ( n = 191) or placebo ( n = 185) for 12 wk. Hemoglobin was measured at baseline and at 12 wk (endline), and change in hemoglobin was calculated in each group for each cutoff. RTM was calculated in the placebo group at each cutoff and applied to the change observed at each cutoff in the iron group to obtain the RTM-free effect.
Results
In the placebo group, mean change in hemoglobin increased as cutoffs became more extreme (0.9 g/L to 1.9 g/L in those with baseline hemoglobin <120 g/L and <110 g/L, respectively). RTM estimates similarly increased: 1.0 g/L (<120 g/L), 1.3 g/L (<115 g/L), and 1.8 g/L (<110g/L). When applying RTM to the iron group, we found that ∼10% of the ""treatment effect"" could be attributable to RTM at each cutoff. However, iron supplementation was still effective in increasing hemoglobin, with an increased effect in those with lower baseline values, as proven by the RTM-free effect at each cutoff: 8.7 g/L (<120 g/L), 10.9 g/L (<115 g/L), and 13.6g/L (<110 g/L).
Conclusions
RTM may have accounted for ∼10% of the observed change in hemoglobin following iron supplementation; however, appropriate use of a placebo group in the statistical analyses of the trial controls for this potential RTM effect.",2020,"In the placebo group, mean change in hemoglobin increased as cutoffs became more extreme (0.9 g/L to 1.9 g/L in those with baseline hemoglobin <120 g/L and <110 g/L, respectively).","['Anemic individuals (hemoglobin <120 g/L', 'women in Cambodia at increasingly severe baseline anemia cutoffs (hemoglobin <120 g/L, <115 g/L, and <110 g/L']",['placebo'],"['RTM', 'change in hemoglobin', 'mean change in hemoglobin', 'Hemoglobin']","[{'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006797', 'cui_str': 'Cambodia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.194265,"In the placebo group, mean change in hemoglobin increased as cutoffs became more extreme (0.9 g/L to 1.9 g/L in those with baseline hemoglobin <120 g/L and <110 g/L, respectively).","[{'ForeName': 'Kelsey M', 'Initials': 'KM', 'LastName': 'Cochrane', 'Affiliation': 'Food, Nutrition, and Health, Faculty of Land and Food Systems, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Brock A', 'Initials': 'BA', 'LastName': 'Williams', 'Affiliation': 'Food, Nutrition, and Health, Faculty of Land and Food Systems, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jordie A J', 'Initials': 'JAJ', 'LastName': 'Fischer', 'Affiliation': 'Food, Nutrition, and Health, Faculty of Land and Food Systems, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kaitlyn L I', 'Initials': 'KLI', 'LastName': 'Samson', 'Affiliation': 'Food, Nutrition, and Health, Faculty of Land and Food Systems, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Lulu X', 'Initials': 'LX', 'LastName': 'Pei', 'Affiliation': 'Food, Nutrition, and Health, Faculty of Land and Food Systems, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Crystal D', 'Initials': 'CD', 'LastName': 'Karakochuk', 'Affiliation': 'Food, Nutrition, and Health, Faculty of Land and Food Systems, The University of British Columbia, Vancouver, British Columbia, Canada.'}]",Current developments in nutrition,['10.1093/cdn/nzaa152']
2157,33150384,Rurioctocog alfa pegol PK-guided prophylaxis in hemophilia A: Results from the phase 3 PROPEL study.,"Rurioctocog alfa pegol prophylaxis targeting factor VIII (FVIII) troughs ≥1% is efficacious and well-tolerated in people with hemophilia A (PwHA). As some may benefit from higher FVIII troughs, the PROPEL trial compared safety and efficacy of 2 target FVIII trough levels in PwHA with severe disease, aged 12-65 years, annualized bleeding rate ≥2, and previous FVIII treatment. They were randomized to 12 months' pharmacokinetic (PK)-guided rurioctocog alfa pegol prophylaxis targeting FVIII troughs of 1-3% (reference arm) or 8-12% (elevated arm). Treatment-adjustment period was in the first 6 months. Primary endpoint: proportion of PwHA (full analysis set [FAS]) with zero total bleeds (all bleeds) during second 6 months. Overall, 115 male PwHA were randomized (N=115, FAS; N=95, per-protocol analysis set [PPAS]). In the 1-3% and 8-12% arms, respectively, point estimates (95% CI) of proportions of PwHA with zero total bleeds were 42% (29-55%) and 62% (49-75%) in FAS (P=0.055) and 40% (27-55%) and 67% (52-81%) in PPAS (P=0.015). Dosing frequency and consumption varied widely in each arm. Adverse events (AEs) occurred in 70/115 (60.9%) PwHA. Serious AEs occurred in 7/115 (6%) PwHA, including 1 treatment-related serious AE in 8-12% arm (transient anti-FVIII inhibitor). There were no deaths, serious thrombotic events, or AE-related discontinuations. PK-guided prophylaxis was achievable and efficacious in both arms, with no new safety signal in the 8-12% arm vs previous studies. These results demonstrate elevated FVIII troughs can increase the proportion of PwHA with zero bleeds and also emphasize the importance of personalized treatment. Trial registration: www.ClinicalTrials.gov (#NCT02585960).",2020,"PK-guided prophylaxis was achievable and efficacious in both arms, with no new safety signal in the 8-12% arm vs previous studies.","['people with hemophilia A (PwHA', 'hemophilia A', '115 male PwHA']","['Rurioctocog alfa pegol PK-guided prophylaxis', 'PK-guided prophylaxis']","['proportion of PwHA (full analysis set [FAS]) with zero total bleeds (all bleeds', 'Adverse events (AEs', 'FAS', 'Serious AEs', 'deaths, serious thrombotic events, or AE-related discontinuations', 'proportions of PwHA with zero total bleeds']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",115.0,0.138856,"PK-guided prophylaxis was achievable and efficacious in both arms, with no new safety signal in the 8-12% arm vs previous studies.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Klamroth', 'Affiliation': 'Vascular Medicine and Haemostaseology, Vivantes Klinikum im Friedrichshain, Berlin, Germany.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Windyga', 'Affiliation': 'Institute of Haematology and Transfusion Medicine, Warsaw, Poland.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Radulescu', 'Affiliation': 'University of Kentucky Medical Center, Lexington, Kentucky, United States.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Collins', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Oleksandra', 'Initials': 'O', 'LastName': 'Stasyshyn', 'Affiliation': 'SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine, Lviv, Ukraine.'}, {'ForeName': 'Hishamshah Mohd', 'Initials': 'HM', 'LastName': 'Ibrahim', 'Affiliation': 'Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Engl', 'Affiliation': 'Baxalta Innovations GmbH, a Takeda company, Vienna, Colorado, Austria.'}, {'ForeName': 'Srilatha D', 'Initials': 'SD', 'LastName': 'Tangada', 'Affiliation': 'Baxalta US Inc., a Takeda company, Cambridge, Massachusetts, United States.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Savage', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts, United States.""}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Ewenstein', 'Affiliation': 'Takeda, Brookline, Massachusetts, United States.'}]",Blood,['10.1182/blood.2020005673']
2158,33150385,"Bone mineral density and bone turnover after sleeve gastrectomy and gastric bypass, a randomized controlled trial.","CONTEXT
Bariatric surgery, particularly Roux-en-Y gastric bypass (RYGB), is associated with increased risk of osteoporotic fractures. It is unknown whether RYGB or sleeve gastrectomy (SG) have different effects on bone health.
OBJECTIVE
To compare changes in bone mineral density and markers of bone turnover one year after SG and RYGB.
DESIGN, SETTING, PATIENTS, AND INTERVENTIONS
Randomized, triple-blind, single-center trial at a tertiary care center in Norway. Primary outcome was diabetes remission. Patients with severe obesity and type 2 diabetes were randomized and allocated (1:1) to SG or RYGB.
MAIN OUTCOME MEASURES
Changes in areal bone mineral density (aBMD) and bone turnover markers.
RESULTS
Femoral neck, total hip, and lumbar spine aBMD, but not total body aBMD, decreased significantly more after RYGB (n=44) than after SG (n=48) [mean (95% CI) between group differences -2.8 % (-0.8 to -4.7), -3.0 % (-0.9 to -5.0), -4.2 % (-2.1 to -6.4), and -0.5 % (0.6 to -1.6), respectively]. The increase in procollagen type 1 N-terminal propeptide (P1NP) and C-telopeptide of type I collagen (CTX-1) were approximately 100% higher after RYGB than after SG, (both time x group, P<0.001). The changes in femoral neck, total hip and lumbar spine aBMDs and the changes in P1NP and CTX-1 were independently associated with the surgical procedure (all P<0.05) and not weight change.
CONCLUSIONS
RYGB was associated with greater reduction in aBMD and greater increase in bone turnover markers compared with SG. This finding could suggest greater skeletal fragility after RYGB.",2020,"RESULTS
Femoral neck, total hip, and lumbar spine aBMD, but not total body aBMD, decreased significantly more after RYGB (n=44) than after SG (n=48) [mean (95% CI) between group differences -2.8 % (-0.8 to -4.7), -3.0 % (-0.9 to -5.0), -4.2 % (-2.1 to -6.4), and -0.5 % (0.6 to -1.6), respectively].",['Patients with severe obesity and type 2 diabetes'],"['RYGB or sleeve gastrectomy (SG', 'SG or RYGB', 'sleeve gastrectomy and gastric bypass']","['skeletal fragility', 'areal bone mineral density (aBMD) and bone turnover markers', 'total body aBMD', 'Bone mineral density and bone turnover', 'aBMD', 'procollagen type 1 N-terminal propeptide (P1NP) and C-telopeptide of type', 'bone turnover markers', 'bone mineral density and markers of bone turnover', 'Femoral neck, total hip, and lumbar spine aBMD', 'diabetes remission', 'femoral neck, total hip and lumbar spine aBMDs and the changes in P1NP and CTX-1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]","[{'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0302113', 'cui_str': 'Fragility'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}]",,0.0413321,"RESULTS
Femoral neck, total hip, and lumbar spine aBMD, but not total body aBMD, decreased significantly more after RYGB (n=44) than after SG (n=48) [mean (95% CI) between group differences -2.8 % (-0.8 to -4.7), -3.0 % (-0.9 to -5.0), -4.2 % (-2.1 to -6.4), and -0.5 % (0.6 to -1.6), respectively].","[{'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Hofsø', 'Affiliation': 'Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Thor Olav Widerøe', 'Initials': 'TOW', 'LastName': 'Hillestad', 'Affiliation': 'Department of Radiology, Vestfold hospital trust, Tønsberg, Norway.'}, {'ForeName': 'Erling', 'Initials': 'E', 'LastName': 'Halvorsen', 'Affiliation': 'Department of Radiology, Vestfold hospital trust, Tønsberg, Norway.'}, {'ForeName': 'Farhat', 'Initials': 'F', 'LastName': 'Fatima', 'Affiliation': 'Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Line Kristin', 'Initials': 'LK', 'LastName': 'Johnson', 'Affiliation': 'Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Lindberg', 'Affiliation': 'Department of Laboratory Medicine, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Svanevik', 'Affiliation': 'Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Sandbu', 'Affiliation': 'Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Jøran', 'Initials': 'J', 'LastName': 'Hjelmesæth', 'Affiliation': 'Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa808']
2159,33150389,Effects of a tailored exercise intervention in acutely hospitalized diabetic oldest old adults: an ancillary analysis.,"OBJECTIVE
To analyze the effects of a tailored exercise intervention in acutely hospitalized oldest old diabetic patients.
RESEARCH DESIGN AND METHODS
This is an ancillary analysis of a randomized controlled trial. 103 acutely hospitalized older adults (mean age ~87 years) with type II diabetes were randomized to an intervention (exercise, n=54) or control group (usual care, n=49). The primary endpoint was change in functional status from baseline to hospital discharge as assessed with the Barthel index and the Short Physical Performance Battery [SSPB]. Secondary endpoints comprised cognitive function and mood status, quality of life (QoL), incidence of delirium, and handgrip strength. Exercise-related side effects, length of hospital stay and incidence of falls during hospitalization we also assessed, as well as transfer to nursing homes, hospital readmission and mortality during a 3-month follow-up.
RESULTS
The median length of stay was 8 days (interquartile range, 4) for both groups. The intervention was safe and provided significant benefits over usual care on SPPB (2.7 [95% confidence interval 1.8, 3.5]) and Barthel Index (8.5 [95% CI: 3.9, 13.1]), as well as on other secondary endpoints such as cognitive status, depression, QoL and handgrip strength (all p<0.05). No significant between-group differences were found for the remainder of secondary endpoints.
CONCLUSIONS
An inhospital individualized multicomponent exercise intervention was safe and effective for the prevention of functional and cognitive decline in acutely hospitalized diabetic oldest old patients, although it had no influence on other endpoints assessed in during hospitalization of at 3-month follow-up after discharge.ClinicalTrials.gov identifier: NCT02300896.",2020,"An inhospital individualized multicomponent exercise intervention was safe and effective for the prevention of functional and cognitive decline in acutely hospitalized diabetic oldest old patients, although it had no influence on other endpoints assessed in during hospitalization of at 3-month follow-up after discharge.","['103 acutely hospitalized older adults (mean age ~87 years) with type II diabetes', 'acutely hospitalized diabetic oldest old patients', 'acutely hospitalized oldest old diabetic patients', 'acutely hospitalized diabetic oldest old adults']","['inhospital individualized multicomponent exercise intervention', 'tailored exercise intervention', 'intervention (exercise, n=54) or control group (usual care']","['cognitive function and mood status, quality of life (QoL), incidence of delirium, and handgrip strength', 'Exercise-related side effects, length of hospital stay and incidence of falls during hospitalization', 'change in functional status from baseline to hospital discharge as assessed with the Barthel index and the Short Physical Performance Battery [SSPB', 'transfer to nursing homes, hospital readmission and mortality', 'Barthel Index', 'cognitive status, depression, QoL and handgrip strength', 'median length of stay']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0001795', 'cui_str': 'Oldest Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",103.0,0.0747968,"An inhospital individualized multicomponent exercise intervention was safe and effective for the prevention of functional and cognitive decline in acutely hospitalized diabetic oldest old patients, although it had no influence on other endpoints assessed in during hospitalization of at 3-month follow-up after discharge.","[{'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Martínez-Velilla', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona (Spain).'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Valenzuela', 'Affiliation': 'Department of Systems Biology, University of Alcalá, Madrid, Spain.'}, {'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Sáez de Asteasu', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona (Spain).'}, {'ForeName': 'Fabricio', 'Initials': 'F', 'LastName': 'Zambom-Ferraresi', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona (Spain).'}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Ramírez-Vélez', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona (Spain).'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García-Hermoso', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona (Spain).'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Librero-López', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona (Spain).'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Gorricho', 'Affiliation': 'Department of Health. Government of Navarra, Pamplona, Spain.'}, {'ForeName': 'Federico Esparza', 'Initials': 'FE', 'LastName': 'Pérez', 'Affiliation': 'Department of Health. Government of Navarra, Pamplona, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lucia', 'Affiliation': 'CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona (Spain).'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa809']
2160,33150388,Chemotherapy or Allogeneic Transplantation in High-Risk Philadelphia Chromosome-Negative Adult Lymphoblastic Leukemia.,"The need for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adults with Philadelphia chromosome-negative (Ph-neg) acute lymphoblastic leukemia (ALL) with high-risk (HR) features and adequate measurable residual disease (MRD) clearance remains unclear. The aim of the ALL-HR-11 trial was to evaluate the outcomes of HR Ph-neg adult ALL patients following chemotherapy or allo-HSCT administered based on end-induction and consolidation MRD levels. Patients aged 15-60 years (y) with HR-ALL in complete response (CR) and MRD levels (centrally assessed by 8-color flow cytometry) <0.1% after induction and <0.01% after early consolidation, were assigned to receive delayed consolidation and maintenance therapy up to 2y in CR. The remaining patients were allocated to allo-HSCT. CR was attained in 315/348 patients (91%), with MRD <0.1% after induction in 220/289 patients (76%). By intention-to treat, 218 patients were assigned to chemotherapy and 106 to allo-HSCT. The 5-year (±95%CI) cumulative incidence of relapse (CIR), overall survival (OS) and event-free survival (EFS) probabilities for the whole series were 43%±7%, 49%±7% and 40±6%, respectively, with CIR and OS rates of 45±8% and 59±9% for patients assigned to chemotherapy and of 40±12% and 38±11% for those assigned to allo-HSCT, respectively. Our results show that avoiding allo-HSCT does not hamper the outcomes of HR Ph-neg adult ALL patients up to 60y with adequate MRD response after induction and consolidation. Better post-remission alternative therapies are especially needed for patients with poor MRD clearance. ClinicalTrials.gov (NCT01540812).",2020,Our results show that avoiding allo-HSCT does not hamper the outcomes of HR Ph-neg adult ALL patients up to 60y with adequate MRD response after induction and consolidation.,"['218 patients were assigned to', 'patients with poor MRD clearance', 'Patients aged 15-60 years (y) with HR-ALL in complete response (CR) and MRD levels (centrally assessed by 8-color flow cytometry) <0.1% after induction and <0.01% after early consolidation', 'adults with Philadelphia chromosome-negative (Ph-neg) acute lymphoblastic leukemia (ALL) with high-risk (HR', 'High-Risk Philadelphia Chromosome-Negative Adult Lymphoblastic Leukemia']","['allo-HSCT', 'chemotherapy or allo-HSCT', 'delayed consolidation and maintenance therapy', 'Chemotherapy or Allogeneic Transplantation', 'chemotherapy and 106 to allo-HSCT', 'allogeneic hematopoietic stem cell transplantation (allo-HSCT']","['5-year (±95%CI) cumulative incidence of relapse (CIR), overall survival (OS) and event-free survival (EFS) probabilities', 'CIR and OS rates', 'CR']","[{'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0016263', 'cui_str': 'Flow cytometry'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3888511', 'cui_str': 'Philadelphia chromosome negative'}, {'cui': 'C0023448', 'cui_str': 'Lymphoid leukemia'}]","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",218.0,0.0706388,Our results show that avoiding allo-HSCT does not hamper the outcomes of HR Ph-neg adult ALL patients up to 60y with adequate MRD response after induction and consolidation.,"[{'ForeName': 'Josep-Maria', 'Initials': 'JM', 'LastName': 'Ribera', 'Affiliation': ""Institut Català d'Oncologia-Hospital Germans Trias i Pujol. Josep Carreras Research Institute. Badalona. Universitat Autònoma de Barcelona, Badalona, Spain.""}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Morgades', 'Affiliation': 'ICO-Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Ciudad', 'Affiliation': 'IBSAL, IBMCC, Centro de Investigación del Cáncer, CIBERONC, Universidad de Salamanca-CSIC, Hospital Universitario de Salamanca, Salamanca, Spain.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Montesinos', 'Affiliation': 'Hospital Universitari i Politècnic La Fe, Valencia, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Esteve', 'Affiliation': 'IDIBAPS, Hospital Clinic.'}, {'ForeName': 'Eulalia', 'Initials': 'E', 'LastName': 'Genesca', 'Affiliation': 'Josep Carreras Leukaemia Research Institute, Badalona, Spain.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Barba', 'Affiliation': ""Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Ribera', 'Affiliation': 'ICO-Hospital Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras, Badalona, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'García Cadenas', 'Affiliation': 'H.Sant Pau, Barcelona.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Moreno', 'Affiliation': 'Hospital Universitario Virgen de la Victoria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martínez-Carballeira', 'Affiliation': 'Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Torrent', 'Affiliation': ""Institut Català d'Oncologia-Hospital Germans Trias i Pujol. Josep Carreras Research Institute. Badalona. Universitat Autònoma de Barcelona, Badalona, Spain.""}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Martínez-Sánchez', 'Affiliation': 'Hospital Doce de Octubre, Madrid, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Monsalvo', 'Affiliation': 'Hospital Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gil', 'Affiliation': 'Hospital Alicante, alicante, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Tormo', 'Affiliation': 'Instituto de Investigación INCLIVA, Spain.'}, {'ForeName': 'María Tersa', 'Initials': 'MT', 'LastName': 'Artola', 'Affiliation': 'Haematology Services, Hospital Universitario de Donostia, Donostia, South Carolina, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cervera', 'Affiliation': 'Haematology Services, Hospital Joan XXIII, Tarragona, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'González-Campos', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Rodríguez-Medina', 'Affiliation': 'Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Arancha', 'Initials': 'A', 'LastName': 'Bermúdez', 'Affiliation': 'Haematology Services, Hospital, Santander, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Novo', 'Affiliation': 'Haematology Services, Hospital Son Espasses, Palma, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Soria', 'Affiliation': 'Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Coll', 'Affiliation': 'Haematological Services, Hospital Josep Trueta, Girona, Spain.'}, {'ForeName': 'María-Luz', 'Initials': 'ML', 'LastName': 'Amigo', 'Affiliation': 'Hospital Morales Meseguer, Murcia, Spain.'}, {'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'López', 'Affiliation': 'Hospital Arnau de Villanova, Valencia, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Fernández Martín', 'Affiliation': 'Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Serrano', 'Affiliation': 'University Hospital Reina Sofia, Cordoba, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Mercadal', 'Affiliation': 'Hospital Duran i Reynals, ICO L´Hospitalet, Barcelona, Spain.'}, {'ForeName': 'Antònia', 'Initials': 'A', 'LastName': 'Cladera', 'Affiliation': 'Hospital Son LLàtzer, Palma, Spain.'}, {'ForeName': 'Alberto Daniel', 'Initials': 'AD', 'LastName': 'Giménez-Conca', 'Affiliation': 'Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'M Jesús', 'Initials': 'MJ', 'LastName': 'Peñarrubia', 'Affiliation': 'Hospital Clínico Universitario de Valladolid, Valladolid, Spain.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Abella', 'Affiliation': 'Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Vall-Llovera', 'Affiliation': 'Hospital Mutua de Terrassa.'}, {'ForeName': 'Jesús M', 'Initials': 'JM', 'LastName': 'Hernández-Rivas', 'Affiliation': 'Hospital Universitario, Salamanca, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Hospital Arnau de Vilanova.'}, {'ForeName': 'Juan Miguel', 'Initials': 'JM', 'LastName': 'Bergua Burgues', 'Affiliation': 'Hospital San Pedro de Alcántara. Cáceres, Caceres, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'de Rueda', 'Affiliation': 'Hospital Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'María-José', 'Initials': 'MJ', 'LastName': 'Sánchez-Sánchez', 'Affiliation': 'Hospital Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Alfons', 'Initials': 'A', 'LastName': 'Serrano', 'Affiliation': 'Hospital HM Sanchinarro, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Calbacho', 'Affiliation': 'Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Alonso Vence', 'Affiliation': 'HOSPITAL OF SANTIAGO DE COMPOSTELA, santiago de compostela, Spain.'}, {'ForeName': 'Jose-Ángel', 'Initials': 'JÁ', 'LastName': 'Méndez-Sánchez', 'Affiliation': 'Complejo Hospitalario de Ourense, Ourense, Spain.'}, {'ForeName': 'Raimundo', 'Initials': 'R', 'LastName': 'García-Boyero', 'Affiliation': 'Hospital General Universitario de Castellón, Castellón, Spain.'}, {'ForeName': 'Matxalen', 'Initials': 'M', 'LastName': 'Olivares', 'Affiliation': 'Hospital de Galdakao, Galdakao, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Barrena', 'Affiliation': 'Centro de Investigación del Cáncer (IBMCC).'}, {'ForeName': 'Lurdes', 'Initials': 'L', 'LastName': 'Zamora', 'Affiliation': ""Hematología. ICO Badalona - HGTiP. Institut d'Investigació contra la Leucèmia Josep Carreras, Badalona, Spain.""}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Granada', 'Affiliation': ""Institut Català d'Oncologia (ICO)-Hospital Germans Trias i Pujol, Institut de Recerca Contra la Leucèmia Josep Carreras, Universitat Autònoma de Barcelona, Badalona, Spain., BADALONA, Spain.""}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Lhermitte', 'Affiliation': 'Université Paris Descartes-Sorbonne Paris Cité, Institut Necker-Enfants-Malades, INSERM UMR1151 APHP, Paris, France.'}, {'ForeName': 'Evarist', 'Initials': 'E', 'LastName': 'Feliu', 'Affiliation': ""Institut Català d'Oncologia-Hospital Germans Trias i Pujol. Josep Carreras Research Institute. Badalona. Universitat Autònoma de Barcelona, Badalona, Spain.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Orfao', 'Affiliation': 'University of Salamanca, Salamanca, Spain.'}]",Blood,['10.1182/blood.2020007311']
2161,33150424,Public attitudes toward an authorization for contact program for clinical research.,"We conducted an online experimental survey to evaluate attitudes toward an authorization for contact (AFC) program allowing researchers to contact patients about studies based on electronic record review. A total of 1070 participants were randomly assigned to 1 of 3 flyers varying in design and framing. Participants were asked to select concerns about and reasons for signing up for AFC. Logistic regression and latent class analysis were conducted. The most commonly selected concerns included needing more information (43%), privacy (40%), and needing more time to think (28%). A minority were not interested in participating in research (16%) and did not want to be bothered (15%). Latent class analysis identified clusters with specific concerns about privacy, lack of interest in research, and not wanting to be bothered. A novel flyer with simple and positive framing was associated with lower odds of both not wanting to be bothered (P = .01) and not being interested in research (P = .01). Many concerns about AFC programs appear nonspecific. Addressing privacy, lack of interest in research, and not wanting to be bothered warrant further study as ways to enhance recruitment.",2020,A novel flyer with simple and positive framing was associated with lower odds of both not wanting to be bothered (P = .01) and not being interested in research (P = .01).,['A total of 1070 participants'],['authorization for contact (AFC) program'],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],1070.0,0.0339943,A novel flyer with simple and positive framing was associated with lower odds of both not wanting to be bothered (P = .01) and not being interested in research (P = .01).,"[{'ForeName': 'Nyiramugisha K', 'Initials': 'NK', 'LastName': 'Niyibizi', 'Affiliation': ''}, {'ForeName': 'Candace D', 'Initials': 'CD', 'LastName': 'Speight', 'Affiliation': 'Georgia Clinical and Translational Science Alliance, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Gregor', 'Affiliation': 'Institute of Translational Health Sciences, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, Georgia, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Kraft', 'Affiliation': 'Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Mitchell', 'Affiliation': 'Georgia Clinical and Translational Science Alliance, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Bradley G', 'Initials': 'BG', 'LastName': 'Phillips', 'Affiliation': 'Department of Clinical and Administrative Pharmacy, University of Georgia College of Pharmacy, Athens, Georgia, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Porter', 'Affiliation': ""Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital and Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Seema K', 'Initials': 'SK', 'LastName': 'Shah', 'Affiliation': ""Research Ethics, Stanley Manne Research Institute, Ann and Robert Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Sugarman', 'Affiliation': 'Johns Hopkins Berman Institute of Bioethics, Baltimore, Maryland, USA.'}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Wilfond', 'Affiliation': 'Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Neal W', 'Initials': 'NW', 'LastName': 'Dickert', 'Affiliation': 'Georgia Clinical and Translational Science Alliance, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocaa214']
2162,31599200,Mortality Benefit of Alirocumab: A Bayesian Perspective.,"Background The ODYSSEY OUTCOMES (Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome) trial demonstrated that alirocumab reduced major cardiovascular events. However, because of the hierarchical testing strategy used for the multiple outcomes examined, the observed reduction in all-cause mortality was labeled ""nominally significant"" which has clouded its interpretation. Methods and Results We re-analyzed data from ODYSSEY OUTCOMES using Bayesian methods and generated various prior probabilities by incorporating mortality data from previous similar PCSK9 (proprotein convertase subtilisin-kexin type 9) inhibitor trials. We first used data from the ODYSSEY OUTCOMES trial with a non-informative prior, then sequentially added data from ODYSSEY LONG TERM and the FOURIER trial, giving FOURIER full weight, 50% weight and 10%. The posterior probability of a mortality reduction using only the ODYSSEY OUTCOMES data was hazard ratio 0.85 (95% CI 0.74-0.99) which corresponded to a 98.4% probability of a mortality benefit. When the ODYSSEY LONG TERM data were added to the analysis, the posterior probability was hazard ratio 0.84 (95% CI 0.72-0.97) with a 99.9% probability of mortality reduction, and when the FOURIER data were added to the analysis the posterior probability was hazard ratio 0.94 (95% CI 0.85-1.04) with an 89.1% probability of a mortality reduction. When the FOURIER trial was given only 50% or 10% weight, the probability of a mortality reduction rose 95.4% and 98.7%, respectively. We estimate that the probability of >1% absolute risk reduction ranges from 8% to 24%, while the probability of >0.5% absolute risk reduction ranges from 66% to 89%. Conclusions Our analysis demonstrates a high likelihood that alirocumab confers a reduction in all-cause mortality, despite the equivocal interpretation of the data in the original ODYSSEY OUTCOMES publication.",2019,The posterior probability of a mortality reduction using only the ODYSSEY OUTCOMES data was hazard ratio 0.85 (95% CI 0.74-0.99) which corresponded to a 98.4% probability of a mortality benefit.,[],"['Alirocumab', 'alirocumab']","['probability of a mortality reduction', 'major cardiovascular events', 'posterior probability of a mortality reduction']",[],"[{'cui': 'C3491162', 'cui_str': 'alirocumab'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]",,0.134233,The posterior probability of a mortality reduction using only the ODYSSEY OUTCOMES data was hazard ratio 0.85 (95% CI 0.74-0.99) which corresponded to a 98.4% probability of a mortality benefit.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Labos', 'Affiliation': 'McGill University Health Center Montreal Canada.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Brophy', 'Affiliation': 'McGill University Health Center Montreal Canada.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Sniderman', 'Affiliation': 'McGill University Health Center Montreal Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Thanassoulis', 'Affiliation': 'McGill University Health Center Montreal Canada.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.013170']
2163,31822114,Nutritional and other health properties of olive pomace oil.,"Olive-pomace oil is rich in oleic acid, and thus it can be an interesting dietary fat alternative as it can allow reaching the recommendation of consuming 20% of total diet energy in the form of monounsaturated fatty acids. In addition, olive-pomace oil also contains a wide range of minor components that may contribute to its healthy properties. The major components identified with healthy properties are triterpenic dialcohols and acids, squalene, tocopherols, sterols, fatty alcohols and phenolic compounds. The refining process, that the crude pomace-oil must undergo for commercial purposes, significantly reduces the content of phenolic compounds, while the other minor components remain at concentrations which can induce positive health effects, especially on cardiovascular health, outstanding pentacyclic triterpenes and aliphatic fatty alcohols in olive-pomace oil. Numerous in vitro and preclinical studies support that mainly the pure compounds, or extracts isolated from plant sources, play an important role in preventing cardiovascular disease and risk factors. Likewise, tocopherols, squalene and phytosterols, in addition to the minor fraction of phenolic compounds, have shown high biological activity with particular association to the cardiovascular function. In the light of the foregoing, and taking into consideration the absence of clinical studies with olive-pomace oil, it would be of great interest to develop randomized, crossover, controlled, double-blind studies to extend the knowledge and understanding on the health effects of olive-pomace olive.",2020,"The refining process, that the crude pomace-oil must undergo for commercial purposes, significantly reduces the content of phenolic compounds, while the other minor components remain at concentrations which can induce positive health effects, especially on cardiovascular health, outstanding pentacyclic triterpenes and aliphatic fatty alcohols in olive-pomace oil.",[],['olive pomace oil'],[],[],"[{'cui': 'C0228539', 'cui_str': 'Olivary nucleus structure'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]",[],,0.0193503,"The refining process, that the crude pomace-oil must undergo for commercial purposes, significantly reduces the content of phenolic compounds, while the other minor components remain at concentrations which can induce positive health effects, especially on cardiovascular health, outstanding pentacyclic triterpenes and aliphatic fatty alcohols in olive-pomace oil.","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Mateos', 'Affiliation': 'Department of Metabolism and Nutrition, Institute of Food Science, Technology and Nutrition (ICTAN), CSIC, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Sarria', 'Affiliation': 'Department of Metabolism and Nutrition, Institute of Food Science, Technology and Nutrition (ICTAN), CSIC, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bravo', 'Affiliation': 'Department of Metabolism and Nutrition, Institute of Food Science, Technology and Nutrition (ICTAN), CSIC, Madrid, Spain.'}]",Critical reviews in food science and nutrition,['10.1080/10408398.2019.1698005']
2164,33151812,Vocabulary Gains in Bilingual Narrative Intervention.,"Purpose The purpose of the current study was to evaluate the effect of bilingual narrative intervention on vocabulary gains in Hebrew (school language) and English (home language) among English-Hebrew bilinguals, using a block design (one language at a time), and to determine whether there was cross-linguistic transfer to the language that was not receiving intervention. Method Sixteen English-Hebrew bilingual children participated in the study using an adaptation of the Puente de Cuentos intervention. Vocabulary was examined using a word definition task before the intervention, post English intervention, post Hebrew intervention, and 4 weeks after the interventions ended to examine maintenance of skills. Results Repeated-measures analyses of variance revealed that children made significant gains in vocabulary in the language of intervention as expected. In addition, children made cross-linguistic gains in Hebrew during the English intervention, but made no gains in English following Hebrew intervention. Conclusion These results underscore the need to provide language support in the home language to ensure growth and that intervention in the home language does not hinder growth in the school language.",2020,Results Repeated-measures analyses of variance revealed that children made significant gains in vocabulary in the language of intervention as expected.,['Method Sixteen English-Hebrew bilingual children participated in the study using an adaptation of the Puente de Cuentos intervention'],['bilingual narrative intervention'],"['Vocabulary Gains', 'vocabulary gains in Hebrew (school language) and English (home language']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0018863', 'cui_str': 'Hebrew language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0018863', 'cui_str': 'Hebrew language'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",16.0,0.0153994,Results Repeated-measures analyses of variance revealed that children made significant gains in vocabulary in the language of intervention as expected.,"[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Armon-Lotem', 'Affiliation': 'Department of English Literature and Linguistics, and the Gonda Brain Research Center, Bar-Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'M Adelaida', 'Initials': 'MA', 'LastName': 'Restrepo', 'Affiliation': 'College of Health Solutions, Arizona State University, Tempe.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Lipner', 'Affiliation': 'Department of English Literature and Linguistics, Bar-Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Peer', 'Initials': 'P', 'LastName': 'Ahituv-Shlomo', 'Affiliation': 'School of Education, Bar-Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Carmit', 'Initials': 'C', 'LastName': 'Altman', 'Affiliation': 'School of Education, and the Gonda Brain Research Center, Bar-Ilan University, Ramat Gan, Israel.'}]","Language, speech, and hearing services in schools",['10.1044/2020_LSHSS-19-00117']
2165,33151847,The use of immersive stories to influence college students' attitudes and intentions related to drinking and driving.,"OBJECTIVE
College students are at risk of drinking and driving. The current study examines the use of immersive stories to prevent college students from drinking and driving.
PARTICIPANTS
107 college students participated in the study.
METHODS
Participants were randomly assigned to watch an immersive 360° video, which featured a story of a young female driver who caused a fatal car crash due to impaired driving, either in head-mounted displays (HMDs) or in tablets.
RESULTS
The story viewed through HMDs (vs. tablets) led to lower intentions to drink and drive only among female participants. Moreover, female participants' perceived similarity to the protagonist mediated the effect of modality on their intentions to drink and drive.
CONCLUSIONS
360° video stories experienced through high immersion (via HMDs) have the potential to prevent risky behavior. It is important to consider the protagonist's gender when adopting immersive stories in alcohol education programs on college campuses.",2020,The story viewed through HMDs (vs. tablets) led to lower intentions to drink and drive only among female participants.,"['107 college students participated in the study', 'College students', 'Participants', 'college students from drinking and driving']","['immersive stories', 'immersive 360° video, which featured a story of a young female driver who caused a fatal car crash due to impaired driving, either in head-mounted displays (HMDs) or in tablets']",[],"[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0556374', 'cui_str': 'Drunk driving'}]","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C1579887', 'cui_str': 'Car crash'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C5197728', 'cui_str': 'Head Worn Display'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]",[],,0.0327389,The story viewed through HMDs (vs. tablets) led to lower intentions to drink and drive only among female participants.,"[{'ForeName': 'Zexin', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Department of Communication, Journalism, and Public Relations, Oakland University, Rochester, Michigan, USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2020.1842418']
2166,33151888,The Impact of Nonminimum-Phase Zeros on Human-in-the-Loop Control Systems.,"We present results from an experiment in which 33 human subjects interact with a dynamic system 40 times over a one-week period. The subjects are divided into three groups. For each interaction, a subject performs a command-following task, where the reference command is the same for all trials and all subjects. However, each group interacts with a different dynamic system, which is represented by a transfer function. The transfer functions have the same poles but different zeros. One has a minimum-phase zero zₘ < 0, another has a nonminimum-phase zero zₙ = - zₘ > 0, and the last has a slower (i.e., closer to the imaginary axis) nonminimum-phase zero zsn ∈ (0,zₙ). The experimental results show that nonminimum-phase zeros tend to make dynamic systems more difficult for humans to learn to control. We use a subsystem identification algorithm to identify the control strategy that each subject uses on each trial. The identification results show that the identified feedforward controllers approximate the inverse dynamics of the system with which the subjects interact better on the last trial than on the first trial. However, the subjects interacting with the minimum-phase system are able to approximate the inverse dynamics in feedforward more accurately than the subjects interacting with the nonminimum-phase system. This observation suggests that nonminimum-phase zeros are an impediment to approximating inverse dynamics in feedforward. Finally, we provide evidence that humans rely on feedforward-step-like-control strategies with systems (e.g., nonminimum-phase systems) for which it is difficult to approximate the inverse dynamics in feedforward.",2020,The identification results show that the identified feedforward controllers approximate the inverse dynamics of the system with which the subjects interact better on the last trial than on the first trial.,['33 human subjects interact with a dynamic system 40 times over a one-week period'],[],[],"[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1442452', 'cui_str': 'One week'}]",[],[],33.0,0.0103914,The identification results show that the identified feedforward controllers approximate the inverse dynamics of the system with which the subjects interact better on the last trial than on the first trial.,"[{'ForeName': 'Xingye', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'T Michael', 'Initials': 'TM', 'LastName': 'Seigler', 'Affiliation': ''}, {'ForeName': 'Jesse B', 'Initials': 'JB', 'LastName': 'Hoagg', 'Affiliation': ''}]",IEEE transactions on cybernetics,['10.1109/TCYB.2020.3027502']
2167,33151934,Evaluation of an intervention to provide brief support and personalized feedback on food shopping to reduce saturated fat intake (PC-SHOP): A randomized controlled trial.,"BACKGROUND
Guidelines recommend reducing saturated fat (SFA) intake to decrease cardiovascular disease (CVD) risk, but there is limited evidence on scalable and effective approaches to change dietary intake, given the large proportion of the population exceeding SFA recommendations. We aimed to develop a system to provide monthly personalized feedback and healthier swaps based on nutritional analysis of loyalty card data from the largest United Kingdom grocery store together with brief advice and support from a healthcare professional (HCP) in the primary care practice. Following a hybrid effectiveness-feasibility design, we tested the effects of the intervention on SFA intake and low-density lipoprotein (LDL) cholesterol as well as the feasibility and acceptability of providing nutritional advice using loyalty card data.
METHODS AND FINDINGS
The Primary Care Shopping Intervention for Cardiovascular Disease Prevention (PC-SHOP) study is a parallel randomized controlled trial with a 3 month follow-up conducted between 21 March 2018 to 16 January2019. Adults ≥18 years with LDL cholesterol >3 mmol/L (n = 113) were recruited from general practitioner (GP) practices in Oxfordshire and randomly allocated to ""Brief Support"" (BS, n = 48), ""Brief Support + Shopping Feedback"" (SF, n = 48) or ""Control"" (n = 17). BS consisted of a 10-minute consultation with an HCP to motivate participants to reduce their SFA intake. Shopping feedback comprised a personalized report on the SFA content of grocery purchases and suggestions for lower SFA swaps. The primary outcome was the between-group difference in change in SFA intake (% total energy intake) at 3 months adjusted for baseline SFA and GP practice using intention-to-treat analysis. Secondary outcomes included %SFA in purchases, LDL cholesterol, and feasibility outcomes. The trial was powered to detect an absolute reduction in SFA of 3% (SD3). Neither participants nor the study team were blinded to group allocation. A total of 106 (94%) participants completed the study: 68% women, 95% white ethnicity, average age 62.4 years (SD 10.8), body mass index (BMI) 27.1 kg/m2 (SD 4.7). There were small decreases in SFA intake at 3 months: control = -0.1% (95% CI -1.8 to 1.7), BS = -0.7% (95% CI -1.8 to 0.3), SF = -0.9% (95% CI -2.0 to 0.2); but no evidence of a significant effect of either intervention compared with control (difference adjusted for GP practice and baseline: BS versus control = -0.33% [95% CI -2.11 to 1.44], p = 0.709; SF versus control = -0.11% [95% CI -1.92 to 1.69], p = 0.901). There were similar trends in %SFA based on supermarket purchases: control = -0.5% (95% CI -2.3 to 1.2), BS = -1.3% (95% CI -2.3 to -0.3), SF = -1.5% (95% CI -2.5 to -0.5) from baseline to follow-up, but these were not significantly different: BS versus control p = 0.379; SF versus control p = 0.411. There were small reductions in LDL from baseline to follow-up (control = -0.14 mmol/L [95% CI -0.48, 0.19), BS: -0.39 mmol/L [95% CI -0.59, -0.19], SF: -0.14 mmol/L [95% CI -0.34, 0.07]), but these were not significantly different: BS versus control p = 0.338; SF versus control p = 0.790. Limitations of this study include the small sample of participants recruited, which limits the power to detect smaller differences, and the low response rate (3%), which may limit the generalisability of these findings.
CONCLUSIONS
In this study, we have shown it is feasible to deliver brief advice in primary care to encourage reductions in SFA intake and to provide personalized advice to encourage healthier choices using supermarket loyalty card data. There was no evidence of large reductions in SFA, but we are unable to exclude more modest benefits. The feasibility, acceptability, and scalability of these interventions suggest they have potential to encourage small changes in diet, which could be beneficial at the population level.
TRIAL REGISTRATION
ISRCTN14279335.",2020,"There were small decreases in SFA intake at 3 months: control = -0.1% (95% CI -1.8 to 1.7), BS = -0.7% (95% CI -1.8 to 0.3), SF = -0.9% (95% CI -2.0 to 0.2); but no evidence of a significant effect of either intervention compared with control (difference adjusted for GP practice and baseline: BS versus control = -0.33% [95% CI -2.11 to 1.44], p = 0.709; SF versus control = -0.11% [95% CI -1.92 to 1.69], p = 0.901).","['Adults ≥18 years with LDL cholesterol >3 mmol/L (n = 113) were recruited from general practitioner (GP) practices in Oxfordshire and randomly allocated to', 'A total of 106 (94%) participants completed the study: 68% women, 95% white ethnicity, average age 62.4 years (SD 10.8), body mass index']","['Brief Support"" (BS, n = 48), ""Brief Support + Shopping Feedback"" (SF, n = 48) or ""Control']","['SFA intake', 'saturated fat intake (PC-SHOP', 'LDL', 'SFA in purchases, LDL cholesterol, and feasibility outcomes', 'SFA intake and low-density lipoprotein (LDL) cholesterol', 'change in SFA intake']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0454871', 'cui_str': 'Oxfordshire'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0556120', 'cui_str': 'Saturated fat intake'}, {'cui': 'C0041472', 'cui_str': 'Murine typhus'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",113.0,0.386053,"There were small decreases in SFA intake at 3 months: control = -0.1% (95% CI -1.8 to 1.7), BS = -0.7% (95% CI -1.8 to 0.3), SF = -0.9% (95% CI -2.0 to 0.2); but no evidence of a significant effect of either intervention compared with control (difference adjusted for GP practice and baseline: BS versus control = -0.33% [95% CI -2.11 to 1.44], p = 0.709; SF versus control = -0.11% [95% CI -1.92 to 1.69], p = 0.901).","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Piernas', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Tsiountsioura', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Noreik', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Nerys M', 'Initials': 'NM', 'LastName': 'Astbury', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Oke', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Madigan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1003385']
2168,33151955,Comprehensive treatment of microvascular angina in overweight women - a randomized controlled pilot trial.,"AIMS
Coronary microvascular dysfunction (CMD) carries a poor cardiovascular prognosis and may explain angina in women without obstructive coronary artery disease (CAD). Currently, no evidence-based treatment for CMD exists. We investigated whether reducing cardiovascular risk factors improves symptoms and microvascular function in women with non-endothelial dependent CMD and no obstructive CAD.
METHODS
We randomized 62 women aged 40-75, with body mass index (BMI) >25 kg/m2, angina ≥monthly, and coronary flow velocity reserve (CFVR) ≤2.5 to a 24-week intervention comprising low energy diet, exercise training, and optimized treatment of hypertension, dyslipidemia and diabetes or to control. Patients were assessed before randomization and after 24 weeks. Primary outcomes were CFVR assessed by transthoracic Doppler stress-echocardiography and angina burden by Seattle Angina Questionnaire (SAQ). Secondary outcomes were exercise capacity, body composition, glycemic control, myocardial function, and anxiety and depression symptoms.
RESULTS
Fifty-six participants (90%) completed the study. Median (IQR) age was 65.2 (57.1;70.7) years, BMI was 30.1 (28.4;32.7) kg/m2. The intervention resulted in relevant improvement in angina symptoms (9-21-point increase on SAQ-scales (all p<0.01)) but had no effect on CFVR (p = 0.468). Mean (CI) weight loss was 9.6 (7.80;11.48) kg, (p<0.0001). There was a significant mean (CI) decrease in depression symptoms = 1.16 (0.22;2.12), triglycerides = 0.52 (0.25;0.78) mmol/L, total cholesterol = 0.55 (0.12;0.98) mmol/L, and HbA1c in diabetics = 27.1 (1.60;52.6) mmol/mol but no effect on other secondary outcomes.
CONCLUSION
A major weight loss and intensified risk factor control resulted in significantly improved angina burden but no improvement of coronary microvascular function among women with microvascular angina.",2020,A major weight loss and intensified risk factor control resulted in significantly improved angina burden but no improvement of coronary microvascular function among women with microvascular angina.,"['women with non-endothelial dependent CMD and no obstructive CAD', 'Fifty-six participants (90%) completed the study', 'women with microvascular angina', 'women without obstructive coronary artery disease (CAD', '62 women aged 40-75, with body mass index (BMI) >25 kg/m2, angina ≥monthly, and coronary flow velocity reserve (CFVR) ≤2.5 to a 24-week intervention comprising', 'microvascular angina in overweight women ']","['low energy diet, exercise training']","['mean (CI) decrease in depression symptoms', 'angina symptoms', 'Median (IQR) age', 'CFVR assessed by transthoracic Doppler stress-echocardiography and angina burden by Seattle Angina Questionnaire (SAQ', 'exercise capacity, body composition, glycemic control, myocardial function, and anxiety and depression symptoms', 'CFVR', 'coronary microvascular function', 'SAQ-scales', 'angina burden', 'Mean (CI) weight loss']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C3696962', 'cui_str': 'Coronary microvascular dysfunction'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206064', 'cui_str': 'Cardiac syndrome X'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0920208', 'cui_str': 'Stress echocardiogram'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",62.0,0.196239,A major weight loss and intensified risk factor control resulted in significantly improved angina burden but no improvement of coronary microvascular function among women with microvascular angina.,"[{'ForeName': 'Kira Bang', 'Initials': 'KB', 'LastName': 'Bove', 'Affiliation': 'Department of Cardiology, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Department of Endocrinology, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lene Rørholm', 'Initials': 'LR', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai', 'Initials': 'N', 'LastName': 'Mikkelsen', 'Affiliation': 'Department of Cardiology, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hannah Elena', 'Initials': 'HE', 'LastName': 'Suhrs', 'Affiliation': 'Department of Cardiology, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Prescott', 'Affiliation': 'Department of Cardiology, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",PloS one,['10.1371/journal.pone.0240722']
2169,33152067,Brief alcohol intervention at a municipal registry office: reach and retention.,"BACKGROUND
The aim was to investigate the suitability of a municipal registry office for alcohol screening and brief intervention. We analyzed whether trial participation and retention differ by alcohol- and health-related, demographic and socio-economic participant characteristics.
METHODS
Over 3 months, all 18- to 64-year-old visitors of a registry office were systematically screened. Persons with alcohol consumption in the past 12 months (N = 1646) were randomized to brief alcohol intervention (BAI) or assessment only. BAI was delivered by computer-generated individualized feedback letters at baseline, 3 and 6 months. Logistic and ordered logistic regression models were used to investigate whether the odds of trial participation and retention depended on participant characteristics. Models were rerun separately for low-risk and at-risk drinkers with Alcohol Use Disorder Identification Test-Consumption scores ≥4/≥5 for women/men indicating at-risk drinking.
RESULTS
The trial participation rate was 67% with higher odds of participation in younger adults (P < 0.001). Retention rates at 3 and 6 months were 85% and 81%, respectively. Higher retention was associated with older age, higher level of school education and non-smoking (all p-values ≤0.05). Low-risk drinkers were more likely to participate in the trial (P < 0.01) and in post-baseline assessments (P < 0.05) than at-risk drinkers.
CONCLUSION
Our data suggest that registry offices could be a suitable setting to reach people from the general population for BAI. Especially the understudied group of low-risk drinkers was well reached through BAI and showed high adherence. BAI that addresses alcohol consumers beyond those at risk may be well accepted in proactively recruited people from the general population.",2020,The trial participation rate was 67% with higher odds of participation in younger adults (P < 0.001).,"['proactively recruited people from the general population', 'Persons with alcohol consumption in the past 12\u2009months (N\u2009=\u20091646']","['brief alcohol intervention (BAI) or assessment only', 'Brief alcohol intervention']","['level of school education and non-smoking', 'Low-risk drinkers', 'Retention rates']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",1646.0,0.021978,The trial participation rate was 67% with higher odds of participation in younger adults (P < 0.001).,"[{'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Enders', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Staudt', 'Affiliation': 'Institute and Policlinic of Occupational and Social Medicine, Faculty of Medicine, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Jennis', 'Initials': 'J', 'LastName': 'Freyer-Adam', 'Affiliation': 'Institute for Medical Psychology, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': 'Department of Prevention Research and Social Medicine, Institute of Community Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Ulbricht', 'Affiliation': 'Department of Prevention Research and Social Medicine, Institute of Community Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'John', 'Affiliation': 'Department of Prevention Research and Social Medicine, Institute of Community Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Baumann', 'Affiliation': 'Institute and Policlinic of Occupational and Social Medicine, Faculty of Medicine, Technische Universität Dresden, Dresden, Germany.'}]",European journal of public health,['10.1093/eurpub/ckaa195']
2170,33152169,"Reduction of stent-associated morbidity by minimizing stent material: A prospective, randomized, single-blind superiority trial assessing a customized ""Suture-Stent"".","OBJECTIVES
To compare a customized Suture-Stent with a standard ureteral stent regarding stent-related symptoms, safety and efficacy.
MATERIALS AND METHODS
Patients with urolithiasis located proximal to the iliac vessel crossing requiring stenting for preparation of secondary URS were randomized to standard ureteral stenting or a Suture-Stent. Secondary ureterorenoscopy was performed 2-6 weeks later. The Ureteral Stent Symptoms Questionnaire was completed after one week, at the day before URS and 2-6 weeks after stent removal. Stent efficacy and safety were systematically assessed.
RESULTS
Totally 88 patients were included to the analysis. Median Suture-Stent length was 10 cm (range 5 - 25 cm) vs. 26 cm for standard stents. Operation time was longer for insertion of the Suture-Stent (24.0 vs. 14.5 min, p<0.001). Patients with a Suture-Stent had a significantly lower USSQ-urinary symptoms score one week after stent insertion adjusted for baseline symptoms by subtracting scores from the final visit without indwelling stent (mean 7.1 vs. 13.7, difference -6.6, 95% CI -3.4 to -9.8, p <0.001). Prior to secondary URS (after 2-6 weeks), baseline-adjusted urinary symptoms (mean 4.7 vs 12.2, difference -7.5, 95% CI -4.5 to -10.4, p <0.001) and pain subscores (11.5 vs 17.6, difference -6.1, 95% CI -0.7 to -11.6, p = 0.004) were significantly lower in the Suture-Stent group. All other USSQ subscores showed no significant differences. Adverse events occurred in 15 patients and similarly frequent in both groups. No significant differences were found between both groups regarding ureteral access during secondary URS.
CONCLUSION
Replacement of the distal part of ureteral stents by a suture can reduce stent-associated symptoms without restrictions regarding secondary stone removal or safety.",2020,"Operation time was longer for insertion of the Suture-Stent (24.0 vs. 14.5 min, p<0.001).","['Patients with urolithiasis located proximal to the iliac vessel crossing requiring stenting for preparation of secondary URS', 'Totally 88 patients were included to the analysis']","['minimizing stent material', 'standard ureteral stenting or a Suture-Stent', 'customized Suture-Stent with a standard ureteral stent regarding stent', 'customized ""Suture-Stent']","['baseline-adjusted urinary symptoms', 'Adverse events', 'Ureteral Stent Symptoms Questionnaire', 'ureteral access', 'Operation time', 'pain subscores', 'Median Suture-Stent length', 'USSQ-urinary symptoms score', 'Stent efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0451641', 'cui_str': 'Urolithiasis'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0729890', 'cui_str': 'Iliac vessel'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0449462', 'cui_str': 'Length of stent'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",88.0,0.188238,"Operation time was longer for insertion of the Suture-Stent (24.0 vs. 14.5 min, p<0.001).","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Betschart', 'Affiliation': 'Department of Urology, Cantonal Hospital St, Gallen St. Gallen, Switzerland.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Piller', 'Affiliation': 'Department of Urology, Cantonal Hospital St, Gallen St. Gallen, Switzerland.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Zumstein', 'Affiliation': 'Department of Urology, Cantonal Hospital St, Gallen St. Gallen, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Schmid', 'Affiliation': 'Department of Urology, Cantonal Hospital St, Gallen St. Gallen, Switzerland.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Engeler', 'Affiliation': 'Department of Urology, Cantonal Hospital St, Gallen St. Gallen, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Güsewell', 'Affiliation': 'Clinical Trials Unit, Cantonal Hospital St, Gallen St. Gallen, Switzerland.'}, {'ForeName': 'Manolis', 'Initials': 'M', 'LastName': 'Pratsinis', 'Affiliation': 'Department of Urology, Cantonal Hospital St, Gallen St. Gallen, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Abt', 'Affiliation': 'Department of Urology, Cantonal Hospital St, Gallen St. Gallen, Switzerland.'}]",BJU international,['10.1111/bju.15290']
2171,33152329,Three-field Lymphadenectomy in Minimally Invasive Esophagectomy for Squamous Cell Carcinoma.,"BACKGROUND
Minimally invasive esophagectomy (MIE) has been used widely for the treatment of esophageal cancer. However, there is still a lack of consensus on the extent of lymphadenectomy in MIE. The objective of this study was to investigate the safety and efficacy of three-field lymphadenectomy (3-FL) in MIE, compared with the standard two-field lymphadenectomy (2-FL).
METHODS
A single-center randomized controlled trial was conducted, enrolling patients with resectable thoracic esophageal cancer (cT 1-3 N 0-3 M 0 ) between June 2016 and May 2019. Eligible patients were randomized into two groups to receive either 3-FL or 2-FL during MIE procedures. Perioperative outcomes of the two groups were compared. The trial was registered in the Chinese Clinical Trial Registry, ChiCTR-INR-16007957.
RESULTS
Seventy-six eligible patients were randomized into the 3-FL group (n=38) and the 2-FL group (n=38). Compared with patients in the 2-FL group, patients in the 3-FL group had more lymph nodes harvested (54.7±16.5 vs. 30.9±9.6; p<0.001) and more metastatic lymph nodes identified (3.5±4.5 vs. 1.7±2.0; p=0.027). Patients in the 3-FL group were diagnosed with a more advanced final pathological TNM stage than those in the 2-FL group. There was no significant difference between the two groups in blood loss, major postoperative complications, or duration of hospital stay, except that the operation time was longer in the 3-FL group than in the 2-FL group (270.5±45.4 minutes vs. 236.7±47.0 minutes, p=0.002).
CONCLUSIONS
Three-field lymphadenectomy allowed harvesting of more lymph nodes and more accurate staging without increased surgical risks compared to the 2-FL in MIE for esophageal cancer.",2020,"There was no significant difference between the two groups in blood loss, major postoperative complications, or duration of hospital stay, except that the operation time was longer in the 3-FL group than in the 2-FL group (270.5±45.4 minutes vs. 236.7±47.0 minutes, p=0.002).
","['Minimally Invasive Esophagectomy for Squamous Cell Carcinoma', 'Eligible patients', 'enrolling patients with resectable thoracic esophageal cancer (cT 1-3 N 0-3 M 0 ) between June 2016 and May 2019', 'Seventy-six eligible patients']","['standard two-field lymphadenectomy (2-FL', 'three-field lymphadenectomy (3-FL', 'invasive esophagectomy (MIE', '2-FL', '3-FL or 2-FL', '3-FL']","['lymph nodes', 'safety and efficacy', 'advanced final pathological TNM stage', 'blood loss, major postoperative complications, or duration of hospital stay, except that the operation time', 'surgical risks', 'metastatic lymph nodes', 'Perioperative outcomes']","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C4319622', 'cui_str': '76'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0039694', 'cui_str': 'Tetranitromethane'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",76.0,0.0666393,"There was no significant difference between the two groups in blood loss, major postoperative complications, or duration of hospital stay, except that the operation time was longer in the 3-FL group than in the 2-FL group (270.5±45.4 minutes vs. 236.7±47.0 minutes, p=0.002).
","[{'ForeName': 'Wei-An', 'Initials': 'WA', 'LastName': 'Song', 'Affiliation': 'Department of Thoracic Surgery, the Sixth Medical Center of Chinese PLA General Hospital, the Second Clinical College of Southern Medical University, Beijing, China.'}, {'ForeName': 'Bo-Shi', 'Initials': 'BS', 'LastName': 'Fan', 'Affiliation': 'Department of Thoracic Surgery, the Sixth Medical Center of Chinese PLA General Hospital, the Second Clinical College of Southern Medical University, Beijing, China.'}, {'ForeName': 'Shou-Yin', 'Initials': 'SY', 'LastName': 'Di', 'Affiliation': 'Department of Thoracic Surgery, the Sixth Medical Center of Chinese PLA General Hospital, the Second Clinical College of Southern Medical University, Beijing, China.'}, {'ForeName': 'Jun-Qiang', 'Initials': 'JQ', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, the Sixth Medical Center of Chinese PLA General Hospital, the Second Clinical College of Southern Medical University, Beijing, China.'}, {'ForeName': 'Jia-Hua', 'Initials': 'JH', 'LastName': 'Zhao', 'Affiliation': 'Department of Thoracic Surgery, the Sixth Medical Center of Chinese PLA General Hospital, the Second Clinical College of Southern Medical University, Beijing, China.'}, {'ForeName': 'Si-Yu', 'Initials': 'SY', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, the Sixth Medical Center of Chinese PLA General Hospital, the Second Clinical College of Southern Medical University, Beijing, China.'}, {'ForeName': 'Cai-Ying', 'Initials': 'CY', 'LastName': 'Yue', 'Affiliation': 'Department of Thoracic Surgery, the Sixth Medical Center of Chinese PLA General Hospital, the Second Clinical College of Southern Medical University, Beijing, China.'}, {'ForeName': 'Shao-Hua', 'Initials': 'SH', 'LastName': 'Zhou', 'Affiliation': 'Department of Thoracic Surgery, the Sixth Medical Center of Chinese PLA General Hospital, the Second Clinical College of Southern Medical University, Beijing, China.'}, {'ForeName': 'Tai-Qian', 'Initials': 'TQ', 'LastName': 'Gong', 'Affiliation': 'Department of Thoracic Surgery, the Sixth Medical Center of Chinese PLA General Hospital, the Second Clinical College of Southern Medical University, Beijing, China. Electronic address: gongtq_thoracic@163.com.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.09.022']
2172,33152354,Preclinical neurorehabilitation with environmental enrichment confers cognitive and histological benefits in a model of pediatric asphyxial cardiac arrest.,"Pediatric asphyxial cardiac arrest (ACA) often leaves children with physical, cognitive, and emotional disabilities that affect overall quality of life, yet rehabilitation is neither routinely nor systematically provided. Environmental enrichment (EE) is considered a preclinical model of neurorehabilitation and thus we sought to investigate its efficacy in our established model of pediatric ACA. Male Sprague-Dawley rat pups (post-natal day 16-18) were randomly assigned to ACA (9.5 min) or Sham injury. After resuscitation, the rats were assigned to 21 days of EE or standard (STD) housing during which time motor, cognitive, and anxiety-like (i.e., affective) outcomes were assessed. Hippocampal CA 1 cells were quantified on post-operative day-22. Both ACA + STD and ACA + EE performed worse on beam-balance vs. Sham controls (p < 0.05) and did not differ from one another overall (p > 0.05); however, a single day analysis on the last day of testing revealed that the ACA + EE group performed better than the ACA + STD group (p < 0.05) and did not differ from the Sham controls (p > 0.05). Both Sham groups performed better than ACA + STD (p < 0.05) but did not differ from ACA + EE (p > 0.05) in the open field test. Spatial learning and declarative memory were improved and CA 1 neuronal loss was attenuated in the ACA + EE vs. ACA + STD group (p < 0.05). Collectively, the data suggest that providing rehabilitation after pediatric ACA can reduce histopathology and improve motor and cognitive ability.",2020,Both Sham groups performed better than ACA + STD (p < 0.05) but did not differ from ACA + EE (p > 0.05) in the open field test.,"['Male Sprague-Dawley rat pups (post-natal day 16-18', 'Pediatric asphyxial cardiac arrest (ACA) often leaves children with physical, cognitive, and emotional disabilities']","['Environmental enrichment (EE', 'ACA']","['motor and cognitive ability', 'CA 1 neuronal loss', 'Spatial learning and declarative memory']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034715', 'cui_str': 'Sprague-Dawley rat'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0582587', 'cui_str': 'Visual learning'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.0463264,Both Sham groups performed better than ACA + STD (p < 0.05) but did not differ from ACA + EE (p > 0.05) in the open field test.,"[{'ForeName': 'Mioara D', 'Initials': 'MD', 'LastName': 'Manole', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, United States of America. Electronic address: manomd@upmc.edu.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Hook', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; University of Bath, Claverton Down, Bath BA2 7AY, UK.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Nicholas', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Brittany P', 'Initials': 'BP', 'LastName': 'Nelson', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Adanna', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Quinn', 'Initials': 'Q', 'LastName': 'Stezoski', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rowley', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Cheng', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Alexander', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Critical Care, Medicine University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Eleni H', 'Initials': 'EH', 'LastName': 'Moschonas', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States of America; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Corina O', 'Initials': 'CO', 'LastName': 'Bondi', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States of America; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Neurobiology, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Kline', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States of America; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA, United States of America; Center for the Neural Basis of Cognition, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Critical Care, Medicine University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Psychology, University of Pittsburgh, Pittsburgh, PA, United States of America. Electronic address: klineae@upmc.edu.'}]",Experimental neurology,['10.1016/j.expneurol.2020.113522']
2173,33152408,A randomised controlled trial of two-unit cantilevered or three-unit fixed-movable resin-bonded fixed partial dentures replacing missing molars: Molar RBB RCT.,"OBJECTIVE
To examine the short-term clinical performance and patient-reported outcomes of two-unit cantilevered (CL2) and three-unit fixed-movable (FM3) RBFPDs for replacement of single molar-sized spans.
MATERIALS AND METHODS
Subjects with an 8-10 mm molar-sized edentulous span(s) and 12 pairs of occluding units were randomly assigned to receive either CL2 or FM3 RBFPD (ratio 1:1). The survival (retention of original prosthesis) and success (survival, complication-free) of RBFPDs at one-year were analysed. Patient-reported outcomes were assessed by prosthesis satisfactory questionnaire and Oral Health Impact Profile (OHIP-49). Data in mean, proportion and longevity were analysed by t-test/Mann-Whitney U test/Wilcoxon signed-rank test, chi-square and log-rank tests respectively at significance level α = 0.05.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier NCT02239718.
RESULTS
Ninety-eight RBFPDs (42 CL2 and 56 FM3) were delivered in eighty-three patients. Majority (n = 89) of the prostheses were provided by operators who have less than 2 years ofclinical experience. Sixty-six patients with seventy-eight RBFPDs (35 CL2 and 43 FM3) were reviewed at one-year. One CL2 and one FM3 RBFPDs debonded, resulting in a success rate at 97.1% and 97.7% respectively (P > 0.05). Both RBFPDs were rebonded and the survival rate were 100% for both designs. No significant difference in satisfactions and summary OHIP-49 scores were observed (P > 0.05).
CONCLUSION
CL2 RBFPDs can be used for replacing molar-sized edentulous spans with minimal observable complications up to one-year. Longer-term data is being collected.
CLINICAL SIGNIFICANCE
This clinical trial demonstrates CL2 RBFPDs have comparable clinical and patient-reported outcomes as the FM3 design. This challenges the current dogma in prosthodontics and expands the clinical use of CL2 design which is more conservative, simpler and easier for patients to maintain.",2020,"The survival (retention of original prosthesis) and success (survival, complication-free) of RBFPDs at one-year were analysed.","['Sixty-six patients with seventy-eight RBFPDs (35 CL2 and 43 FM3', 'Subjects with an 8-10\u2009mm molar-sized edentulous span(s) and 12 pairs of occluding units', 'Majority (n\u2009=\u200989) of the prostheses were provided by operators who have less than 2 years ofclinical experience', 'two-unit cantilevered or three-unit fixed-movable resin-bonded fixed partial dentures replacing missing molars: Molar RBB RCT']","['two-unit cantilevered (CL2) and three-unit fixed-movable (FM3) RBFPDs', 'CL2 or FM3 RBFPD', 'CL2 RBFPDs']","['survival (retention of original prosthesis) and success (survival, complication-free) of RBFPDs', 'success rate', 'satisfactions and summary OHIP-49 scores', 'prosthesis satisfactory questionnaire and Oral Health Impact Profile (OHIP-49', 'survival rate']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0085071', 'cui_str': 'Maryland bridge'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}]","[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",66.0,0.136544,"The survival (retention of original prosthesis) and success (survival, complication-free) of RBFPDs at one-year were analysed.","[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Botelho', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong. Electronic address: botelho@hku.hk.'}, {'ForeName': 'Madeline J Y', 'Initials': 'MJY', 'LastName': 'Yon', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ken C K', 'Initials': 'KCK', 'LastName': 'Mak', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Walter Y H', 'Initials': 'WYH', 'LastName': 'Lam', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103519']
2174,33152443,"The Effects of Clinical Music Therapy on Resiliency in Adults Undergoing Infusion: A Randomized, Controlled Trial.","CONTEXT
Eighty-seven newly diagnosed Lung, Breast, or Gastrointestinal Cancer patients undergoing chemotherapy in the Infusion Suite of a large urban hospital in NYC.
OBJECTIVE
Patients were enrolled in this study of music therapy's impact on resilience in coping with the impact of symptoms inclusive of symptom clustering.
METHODS
Patients were randomly assigned to 3 arms: 43 subjects: clinical instrumental improvisation or clinical vocal improvisation, 44 subjects-control. All subjects received a Medical Music Psychotherapy Assessment including psychosocial information and music preferences, pre/post Resilience Scale (RS), Hospital Anxiety and Depression Scale (HADS), Visual Analogue Scale, Faces Scale (VAS) and a pain- Color Analysis Scale (CAS).
INTERVENTIONS
20-minute MT, and two additional sessions.
RESULTS
Significant increases in RS in MT groups post treatment with instrumental and vocal MT interventions equally potent- reflect average changes of 3.4 and 4.83 (p = .625), respectively. Although HADS scores showed little impact of MT on perceived anxiety/depression, a strong correlation is seen between vocal intervention and lower depression scores through VAS rendered post sessions. This yielded a significant decrease in pain levels immediately after MT, with the final session showing the most significant change in pain level. Resilience in enduring procedures is a necessary component of combating potential negative illness perception.
CONCLUSION
Our study shows MT's facility to propel resilience in newly diagnosed cancer patients, particularly when promoting and pairing adaptation toward coping through the expression of perceived negative effects of emotional and physiological symptoms.",2020,"This yielded a significant decrease in pain levels immediately after MT, with the final session showing the most significant change in pain level.","['Adults Undergoing Infusion', 'Patients were randomly assigned to 3 arms: 43 subjects', 'Eighty-seven newly diagnosed Lung, Breast, or Gastrointestinal Cancer patients undergoing chemotherapy in the Infusion Suite of a large urban hospital in NYC', 'newly diagnosed cancer patients']","['clinical instrumental improvisation or clinical vocal improvisation, 44 subjects-control', 'Clinical Music Therapy', 'Medical Music Psychotherapy Assessment']","['pain level', 'pain levels', 'psychosocial information and music preferences, pre/post Resilience Scale (RS), Hospital Anxiety and Depression Scale (HADS), Visual Analogue Scale, Faces Scale (VAS) and a pain- Color Analysis Scale (CAS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}]",87.0,0.0793848,"This yielded a significant decrease in pain levels immediately after MT, with the final session showing the most significant change in pain level.","[{'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Mondanaro', 'Affiliation': 'Clinical Director, The Louis Armstrong Department of Music Therapy, Mount Sinai Beth Israel, New York, NY, 10003. Electronic address: John.Mondanaro@mountsinai.org.'}, {'ForeName': 'Gabriel A', 'Initials': 'GA', 'LastName': 'Sara', 'Affiliation': 'Medical Director, Infusion Suite at Mount Sinai West, Assistant Professor of Medicine, Icahn School of Medicine at Mount Sinai, Division of Hematology & Oncology, 425 West 59(th) Street - 8(th) Floor, New York, NY, 10019.'}, {'ForeName': 'Roshni', 'Initials': 'R', 'LastName': 'Thachil', 'Affiliation': 'Stanford University School of Engineering, Stanford, CA, 94305-6104.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Pranjić', 'Affiliation': 'PhD student, Music and Health Science Research Collaboratory, University of Toronto, Toronto, Ontario, M5S 1A1, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rossetti', 'Affiliation': 'Supervisor, Radiation Oncology Music Therapy Program, Louis Armstrong Center for Music and Medicine, Mount Sinai Beth Israel, New York, NY, 10003.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'EunHye Sim', 'Affiliation': 'NYC Health+Hospitals, New York, NY, 10013.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Canga', 'Affiliation': 'Eastern Virginia Medical School, Norfolk, VA, 23507.'}, {'ForeName': 'Ilene Brodoff', 'Initials': 'IB', 'LastName': 'Harrison', 'Affiliation': 'Louis Armstrong Center for Music and Medicine, Mount Sinai West, New York, NY, 10003.'}, {'ForeName': 'Joanne V', 'Initials': 'JV', 'LastName': 'Loewy', 'Affiliation': 'Director, The Louis Armstrong Center for Music and Medicine, Associate Professor Icahn School of Medicine at Mount Sinai, Mount Sinai Health System, New York, NY, 10003.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.10.032']
2175,33155462,The importance of plasma ferritin values in blood donors for the evaluation of body iron store in a five-month period.,"Aim To present haemoglobin and ferritin parameters in donors to highlight the importance of serum ferritin testing for the purpose of evaluating iron depots in order to make recommendations for preserving a population of blood donors. Method A prospective study was conducted on 80 blood donors divided in two groups: group I (regular donors, n =40) and group II (irregular donors, n=40). Haemoglobin and ferritin were measured twice every 45 days, before two consecutive blood donations. Results By measuring haemoglobin and ferritin values before donation in both groups, a decrease of initial ferritin value in Group I relative to Group II was observed (without statistical significance). A significant decrease was found between repeated measurements for both parameters in both groups, indicating equal intensity of the decline in value regardless of a donor status. Measurement of ferritin before and after donation revealed statistically significant loss of ferritin in all examinees (p=0.011). The decline in haemoglobin after donation, although significant, did not fall below the reference value for donation in either women or men. Conclusion Results indicate the need for periodic monitoring of the plasma value of ferritin in voluntary donors who donate blood more than twice a year and the possible oral supplementation with iron.",2021,Measurement of ferritin before and after donation revealed statistically significant loss of ferritin in all examinees (p=0.011).,"['80 blood donors divided in two groups: group I (regular donors, n =40) and group II (irregular donors, n=40']",[],"['Haemoglobin and ferritin', 'plasma ferritin values', 'haemoglobin and ferritin values', 'initial ferritin value']","[{'cui': 'C0005795', 'cui_str': 'Blood donor'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0205271', 'cui_str': 'Irregular'}]",[],"[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",80.0,0.0121531,Measurement of ferritin before and after donation revealed statistically significant loss of ferritin in all examinees (p=0.011).,"[{'ForeName': 'Elma', 'Initials': 'E', 'LastName': 'Ćatović-Baralija', 'Affiliation': 'Department for Blood-Borne Disease Testing, Blood Transfusion Institute of the Federation of Bosnia and Herzegovina, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Gorana', 'Initials': 'G', 'LastName': 'Ahmetović-Karić', 'Affiliation': 'Department for Blood-Borne Disease Testing, Blood Transfusion Institute of the Federation of Bosnia and Herzegovina, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Sabaheta', 'Initials': 'S', 'LastName': 'Hasić', 'Affiliation': 'Department of Medical Biochemistry, School of Medicine, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Nesina', 'Initials': 'N', 'LastName': 'Avdagić', 'Affiliation': 'Department of Human Physiology, School of Medicine, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Nermina', 'Initials': 'N', 'LastName': 'Babić', 'Affiliation': 'Department of Human Physiology, School of Medicine, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}]","Medicinski glasnik : official publication of the Medical Association of Zenica-Doboj Canton, Bosnia and Herzegovina",['10.17392/1223-21']
2176,33155484,"Comparing the effects of no intervention with therapeutic exercise, and exercise with additional Kinesio tape in patients with shoulder impingement syndrome. A three-arm randomized controlled trial.","OBJECTIVE
To investigate if adding Kinesio tape to therapeutic exercise is an effective treatment to improve clinical outcomes compared to therapeutic exercise alone and no intervention, in patients with shoulder impingement syndrome.
DESIGN
Three-arm randomized controlled trial.
SETTING
Outpatient setting.
SUBJECTS
One hundred and twenty patients (mean (SD): age 37.8 (5.4)) with shoulder impingement syndrome.
INTERVENTION
Patients were randomly assigned to eight-weeks therapeutic exercise alone, therapeutic exercise with Kinesio tape, and control group.
MAIN MEASURES
Pain was measured with a numerical rating scale and disability and scapular kinematics were measured with a relative questionnaire and motion analysis software respectively, at baseline and after eight-weeks intervention.
RESULTS
There was significant differences in therapeutic exercise with Kinesio tape group vs. therapeutic exercise alone and control group respectively for pain ( d = -0.34, P = 0.042; and d = -1.53, P = 0.001), disability ( d = -0.46, P = 0.024; and d = -2.18, P = 0.001), scapular upward rotation at sagittal plane ( d = 0.33, P = 0.033; and d = 0.68, P = 0.001), scapular plane ( d = 0.18, P = 0.045; and d = 0.43, P = 0.001), scapular tilt at sagittal plane ( d = 0.55, P = 0.043; and d = 1.39, P = 0.001), and scapular plane ( d = 0.29, P = 0.034; and d = 0.58, P = 0.001). Therapeutic exercise alone was superior over control group in all significant outcomes ( P < 0.05).
CONCLUSION
Although therapeutic exercises alone showed positive effect on clinical outcomes, adding Kinesio tape to therapeutic exercises had more significant effects with larger effect sizes. Adding Kinesio tape to therapeutic exercise may be of some assistance to clinicians in improving clinical outcomes in patients with shoulder impingement syndrome.",2020,"Therapeutic exercise alone was superior over control group in all significant outcomes ( P < 0.05).
","['patients with shoulder impingement syndrome', 'One hundred and twenty patients (mean (SD): age 37.8 (5.4)) with shoulder impingement syndrome', 'Outpatient setting']","['therapeutic exercise alone, therapeutic exercise with Kinesio tape, and control group', 'Kinesio tape to therapeutic exercise', 'no intervention with therapeutic exercise, and exercise with additional Kinesio tape']","['scapular upward rotation at sagittal plane', 'scapular tilt at sagittal plane', 'numerical rating scale and disability and scapular kinematics', 'disability', 'Pain', 'scapular plane', 'therapeutic exercise', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1282911', 'cui_str': 'Upward'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]",120.0,0.0882511,"Therapeutic exercise alone was superior over control group in all significant outcomes ( P < 0.05).
","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Sports injury and corrective exercises, Faculty of physical education and sports sciences, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Pouya', 'Initials': 'P', 'LastName': 'Rabiei', 'Affiliation': 'Department of Physical Education and Sports Sciences, Karaj Branch, Islamic Azad University, Karaj, Iran.'}, {'ForeName': 'Sarvenaz', 'Initials': 'S', 'LastName': 'Kazempour', 'Affiliation': 'Sports injury and corrective exercises, Faculty of physical education and sports sciences, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Alaei-Parapari', 'Affiliation': 'Sports injury and corrective exercises, Faculty of physical education and sports sciences, Kharazmi University, Tehran, Iran.'}]",Clinical rehabilitation,['10.1177/0269215520971764']
2177,33155562,"""Can patients learn how to reduce their shoulder dislocation?"" A one-year follow-up of the randomized clinical trial between the Boss-Holzach-Matter self-assisted technique and the Spaso method.","OBJECTIVE
The aim of this study was to assess the effectiveness and reproducibility of self-assisted Boss-Holzach-Matter (BHM) technique compared with the Spaso (Sp) method for shoulder dislocation.
METHODS
We conducted a follow-up at 1 year from the randomization of 60 patients with shoulder dislocation enrolled in the study ""Teaching patients to reduce a shoulder dislocation."" Half of these patients had been taught the self-assisted technique, whereas the other half had been treated by a physician's manipulative maneuver for reduction. We surveyed all the enrolled patients to describe recurrence rates and reproducibility for both the techniques without supervision as well as the number of emergency visits.
RESULTS
In total, 52 patients (age range: 18-44 years) answered the survey from the 60 patients enrolled in the study. The total rate of recurrence was 38.5% (20 patients). For the Sp group, 4 of the 30 patients were lost. There were 9 recurrent patients (30%), and 7 were treated in the emergency department (ED). For the BHM group, 4 of the 30 patients were lost. There were 11 recurrent patients (37%), and 2 were treated in the ED. The difference in self-reduction rates and ED visits for both the groups was statistically significant (p=0.025).
CONCLUSION
Teaching the BHM technique to the patients is effective and reproducible without direct supervision. It can decrease the number of visits to the ED and is a valid option to teach the patients at risk of recurrence when not being able to get immediate help.
LEVEL OF EVIDENCE
Level I, Therapeutic study.",2020,"The difference in self-reduction rates and ED visits for both the groups was statistically significant (p=0.025).
","['60 patients with shoulder dislocation enrolled in the study ""Teaching patients to reduce a shoulder dislocation', '52 patients (age range: 18-44 years) answered the survey from the 60 patients enrolled in the study']","['self-assisted Boss-Holzach-Matter (BHM) technique compared with the Spaso (Sp', 'Holzach-Matter self-assisted technique and the Spaso method']","['self-reduction rates and ED visits', 'total rate of recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037005', 'cui_str': 'Dislocation of shoulder joint'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",60.0,0.0330681,"The difference in self-reduction rates and ED visits for both the groups was statistically significant (p=0.025).
","[{'ForeName': 'Francesc A', 'Initials': 'FA', 'LastName': 'Marcano-Fernández', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Fillat-Gomà', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Balaguer-Castro', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}, {'ForeName': 'Ona', 'Initials': 'O', 'LastName': 'Ràfols-Perramon', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Serrano-Sanz', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Torner', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.19017']
2178,33155565,Assessing the role of hip arthrography in the treatment decision making for children with Legg-Calvé-Perthes disease.,"OBJECTIVE
The aim of this study was to determine the role of hip arthrography in the treatment decision making for children with Legg-Calvé-Perthes disease (LCPD).
METHODS
A total of 47 consecutive children with LCPD (42 boys, 5 girls; mean age=7.5 years; range=6-10 years) who underwent operative treatment were included in the study. The patient demographics, physical examination findings (pain and hip range of motion [ROM]), standard anteroposterior and Löwenstein lateral hip radiographs, and hip arthrography data were retrospectively collected. The arthrographies were performed immediately before the surgery under general anesthesia. The patients were staged according to the Catterall and Herring classifications and examined in terms of head-at-risk signs before the study. Four sets of patient files were established based on the aforementioned data, with each child in a randomized and blinded order. Ten consultant pediatric orthopedic surgeons randomly assessed the patient files on 4 separate occasions (Set 1 vs Set 2 and Set 3 vs Set 4), with a minimum time interval of 4 weeks. In the first and second sets, the demographic and clinical information, including the age, gender, hip ROM, and hip radiographs, were presented. In the third and fourth sets, hip arthrography was presented in addition to the data from Set 1 and Set 2. The observers were instructed to choose the best treatment options. The percent agreement (PA) and Gwet's AC1 statistics were used to establish a relative level of agreement among the observers.
RESULTS
The mean intra-observer reliabilities ranged from fair to moderate after adding the hip arthrography data (Gwet's AC1 = 0.36 for Set 1 vs Set 2 and 0.42 for Set 3 vs Set 4). The mean PA was 56.6% (range = 29.8% to 78.7%) with a Gwet's AC1 value of 0.51 (range: 0.21 to 0.77) between Set 1 and Set 3 (moderate intra-observer reliability). The decision for the treatment strategy was changed in 43.4% of the patients. For inter-observer reliability, Gwet's AC1 was computed as 0.48 (moderate reliability). The correlation between the intra-observer reliability and stage progression was not significant (p>0.05) for any of the subgroups. Thus, there is a negative correlation with the disease progression.
CONCLUSION
Hip arthrography seems to have a significant role in the treatment decision making for children with LCPD, especially in the advanced stages of the disease.
LEVEL OF EVIDENCE
Level IV, Therapeutic study.",2020,The correlation between the intra-observer reliability and stage progression was not significant (p>0.05) for any of the subgroups.,"['47 consecutive children with LCPD (42 boys, 5 girls; mean age=7.5 years; range=6-10 years) who underwent operative treatment were included in the study', 'children with Legg-Calvé-Perthes disease', 'children with Legg-Calvé-Perthes disease (LCPD', 'children with LCPD']",['hip arthrography'],"['patient demographics, physical examination findings (pain and hip range of motion [ROM]), standard anteroposterior and Löwenstein lateral hip radiographs, and hip arthrography data', 'intra-observer reliability and stage progression', 'mean intra-observer reliabilities', 'mean PA']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0003885', 'cui_str': 'Arthrography'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0003885', 'cui_str': 'Arthrography'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",47.0,0.0265941,The correlation between the intra-observer reliability and stage progression was not significant (p>0.05) for any of the subgroups.,"[{'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Erkuş', 'Affiliation': 'Department of Orthopaedics and Traumatology, Tepecik Training and Research Hospital İzmir, Turkey.'}, {'ForeName': 'Önder', 'Initials': 'Ö', 'LastName': 'Kalenderer', 'Affiliation': 'Department of Orthopaedics and Traumatology, Tepecik Training and Research Hospital İzmir, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Turgut', 'Affiliation': 'Department of Orthopaedics and Traumatology, Tepecik Training and Research Hospital İzmir, Turkey.'}, {'ForeName': 'Tayfun', 'Initials': 'T', 'LastName': 'Bacaksız', 'Affiliation': 'Department of Orthopaedics and Traumatology, Akçakale State Hospital Şanlıurfa, Turkey.'}, {'ForeName': 'Özkan', 'Initials': 'Ö', 'LastName': 'Köse', 'Affiliation': 'Department of Orthopaedics and Traumatology, Antalya Training and Research Hospital Antalya, Turkey.'}, {'ForeName': 'Kıvanç', 'Initials': 'K', 'LastName': 'Yüksel', 'Affiliation': 'Department of Data Management and Biostatistics, Ege University, School of Medicine ARGEFAR, İzmir, Turkey.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.19075']
2179,33155849,The burden of musculoskeletal pain and the role of topical Non-steroidal anti-inflammatory drugs (NSAIDs) in its treatment. Ten underpinning statements from a global pain faculty.,"This document presents the conclusions of a detailed discussion on the role of topical NSAIDs during a round table Global Pain Faculty meeting held in Amsterdam in 2019 and subsequent discussions online. The aim of this evidence-based document is to describe the impact of musculoskeletal pain both in terms of the large numbers of sufferers and its economic impact. The document considers the place of topical therapies alongside other pharmacological and non-pharmacological treatments and presents the evidence for the benefits and harms of topical NSAIDS including indicators of efficacy for three main topical NSAIDs-diclofenac, ibuprofen and ketoprofen-based on almost 15,000 participants in randomised controlled trials for acute and chronic musculoskeletal pain. These topical NSAIDs have the largest body of evidence. For acute pain, numbers needed to treat to achieve at least 50% reduction in pain are as follows with 95% confidence intervals in brackets: Diclofenac emulgel 1.8(1.5-2.1) (5170 participants), Ibuprofen gel 2.7 (1.7-4.2) (436 participants), Ketoprofen gel 2.2 (1.7-2.8) (683 participants). For chronic pain, the NNTs are Diclofenac any formulation 9.5(7-14) (5995 participants). Ketoprofen 6.9(5.5-9.3) (2573 participants). Randomised controlled trial evidence suggests that adverse events for active topical NSAIDs are similar to placebo. Finally the gaps in knowledge are considered with suggestions on how further research might help. The global pain faculty was brought together by GSK under an unrestricted educational grant.",2020,"For chronic pain, the NNTs are Diclofenac any formulation 9.5(7-14) (5995 participants).","['15,000 participants in randomised controlled trials for acute and chronic musculoskeletal pain']","['diclofenac, ibuprofen and ketoprofen', 'Ibuprofen gel', 'placebo', 'Ketoprofen', 'Ketoprofen gel']","['burden of musculoskeletal pain', 'pain']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.361133,"For chronic pain, the NNTs are Diclofenac any formulation 9.5(7-14) (5995 participants).","[{'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'McMahon', 'Affiliation': ""Wellcome Trust Pain Consortium, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dargan', 'Affiliation': ""Guy's & St Thomas' NHS Foundation Trust and King's College London, London, UK.""}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Lanas', 'Affiliation': 'University of Zaragoza, University Clinic Hospital, CIBERehd, IIS Aragón, Zaragoza, Spain.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Wiffen', 'Affiliation': 'University of Bath, Bath, UK.'}]",Current medical research and opinion,['10.1080/03007995.2020.1847718']
2180,33155862,Impact of a Novel Goals-of-Care Communication Skills Coaching Intervention for Practicing Oncologists.,"Background: Oncologists routinely have opportunities for goals-of-care (GoC) discussions with patients. GoC discussions increase the likelihood that patients receive care consistent with their values. However, oncologists often feel ill-equipped to discuss end-of-life care. Objective: To assess the impact of a communication training and coaching intervention (INT) for oncologists during GoC discussions. Design: We randomized oncologists to usual care (UC) or a communication skills training INT, which consisted of an interactive training session and four joint visits with communication coaches. Setting/Subjects: Solid tumor oncologists seeing advanced cancer patients at four hospitals in New York and Connecticut. Measurements: Three blinded coders evaluated recorded encounters before and after INT using a validated tool to assess skill attainment. Results: Oncologists ( n = 22) were 32% female and averaged 46 years of age. In baseline visits, INT oncologists ( n = 11) and UC oncologists ( n = 11) had no difference in the number of mean skills employed out of 8 GoC skills (INT 3.5, UC 2.4; p = 0.18). Post-INT, INT oncologists were significantly more likely to elicit patient values (55% vs. 0%; p = 0.01). There was no significant difference in overall mean skills employed (INT 3.4, UC 2.2; p = 0.14). Assessing for understanding, offering ""I wish"" statements, and providing prognosis were the least utilized skills among all oncologists. Conclusion: Our real-time communication skills coaching INT resulted in a significant increase in oncologists' ability to elicit patient values during GoC discussions, suggesting that skill acquisition can occur in the face of less intensive training. Future studies can highlight gaps leading to the lack of differences in utilization of other skills.",2020,"Our real-time communication skills coaching INT resulted in a significant increase in oncologists' ability to elicit patient values during GoC discussions, suggesting that skill acquisition can occur in the face of less intensive training.","['Results: Oncologists ( n \u2009=\u200922) were 32% female and averaged 46 years of age', 'advanced cancer patients at four hospitals in New York and Connecticut', 'Practicing Oncologists']","['usual care (UC) or a communication skills training INT, which consisted of an interactive training session and four joint visits with communication coaches', 'Novel Goals-of-Care Communication Skills Coaching Intervention', 'communication training and coaching intervention (INT']","['overall mean skills employed', 'number of mean skills employed out of 8 GoC skills']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0009778', 'cui_str': 'Connecticut'}]","[{'cui': 'C0588407', 'cui_str': 'Communication skills training'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.0469648,"Our real-time communication skills coaching INT resulted in a significant increase in oncologists' ability to elicit patient values during GoC discussions, suggesting that skill acquisition can occur in the face of less intensive training.","[{'ForeName': 'Vasantham', 'Initials': 'V', 'LastName': 'Annadurai', 'Affiliation': 'Department of Medicine, NewYork-Presbyterian/Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Cardinale B', 'Initials': 'CB', 'LastName': 'Smith', 'Affiliation': 'Division of Hematology/Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Bickell', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Berns', 'Affiliation': 'Division of Palliative Medicine, Department of Family Medicine, The Robert Larner, MD College of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Kelley', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lindenberger', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Morrison', 'Affiliation': 'Yale Palliative Care Program, Department of Medicine, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Jacqueline K', 'Initials': 'JK', 'LastName': 'Yuen', 'Affiliation': 'Division of Geriatrics, Department of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Egorova', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Franco', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Back', 'Affiliation': 'Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Gelfman', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}]",Journal of palliative medicine,['10.1089/jpm.2020.0207']
2181,33155876,Comparative Effects of Single-Dose Cardioplegic Solutions Especially in Repeated Doses During Minimally Invasive Aortic Valve Surgery.,"OBJECTIVE
This study aims to compare del Nido cardioplegia (DNC) and histidine-tryptophan-ketoglutarate (HTK) cardioplegic solutions in minimally invasive aortic valve replacement (mini-AVR) surgery to discuss the safety level of myocardial protection and rationale for redosing intervals.
METHODS
During the period from January 2017 to June 2019, 200 patients undergoing mini-AVR (solely or with concomitant procedures) were prospectively randomized to DNC ( n = 100) andHTK ( n = 100), both up to 90 minutes ischemic time. Patients with ischemic time over 90 minutes, needing a redosing, were further analyzed in 2 subgroups with DNC-R ( n = 30) and HTK-R ( n = 36). Sensitive biomarkers, in addition to routine biochemistry, were also documented at baseline (T1), after cessation of cardiopulmonary bypass (T2), and on the first postoperative day (T3). Transmural myocardial biopsies were sampled for staining.
RESULTS
No statistical differences could be demonstrated in DNC and HTK groups with up to 90 minutes cross-clamp times in routine biochemical measurements and basic perioperative clinical outcomes. DNC-R showed significantly more arrhythmia/AV block incidence resulting in more extended intensive care unit (ICU) stay. Interleukin-6 and syndecan-1 in DNC and DNC-R groups were substantially higher at T2. Aquaporin-4 levels were significantly lower in the DNC-R group, demonstrating unsatisfactory response of cells to an excessive volume at T2.
CONCLUSIONS
DNC and HTK provided acceptable myocardial protection as single-dose applications. DNC-R had significantly unbalanced levels of biomarkers, and more arrhythmia/AV block incidence resulting in more extended ICU stay. For patients who may need redosing HTK may be preferable to DNC.",2020,No statistical differences could be demonstrated in DNC and HTK groups with up to 90 minutes cross-clamp times in routine biochemical measurements and basic perioperative clinical outcomes.,"['Patients with ischemic time over 90 minutes, needing a redosing, were further analyzed in 2 subgroups with DNC-R ( n = 30) and HTK-R ( n = 36', '200 patients undergoing mini-AVR (solely or with concomitant procedures', 'minimally invasive aortic valve replacement (mini-AVR) surgery']","['Nido cardioplegia (DNC) and histidine-tryptophan-ketoglutarate (HTK) cardioplegic solutions', 'Single-Dose Cardioplegic Solutions', 'DNC and HTK', 'DNC']","['Transmural myocardial biopsies', 'Aquaporin-4 levels', 'arrhythmia/AV block incidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0019602', 'cui_str': 'Histidine'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0019602', 'cui_str': 'Histidine'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0007200', 'cui_str': 'cardioplegia solutions'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0522497', 'cui_str': 'Transmural'}, {'cui': 'C1304881', 'cui_str': 'Myocardial biopsy'}, {'cui': 'C0292777', 'cui_str': 'Aquaporin-4'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0004245', 'cui_str': 'Atrioventricular block'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",200.0,0.0214565,No statistical differences could be demonstrated in DNC and HTK groups with up to 90 minutes cross-clamp times in routine biochemical measurements and basic perioperative clinical outcomes.,"[{'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Gunaydin', 'Affiliation': '448249 Department of Cardiovascular Surgery, Ankara City Hospital, Turkey.'}, {'ForeName': 'Esin', 'Initials': 'E', 'LastName': 'Akbay', 'Affiliation': '198375 Faculty of Science, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Orhan Eren', 'Initials': 'OE', 'LastName': 'Gunertem', 'Affiliation': '448249 Department of Cardiovascular Surgery, Ankara City Hospital, Turkey.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McCusker', 'Affiliation': '8137 New York Medical College, Valhalla, NY, USA.'}, {'ForeName': 'Atike Tekeli', 'Initials': 'AT', 'LastName': 'Kunt', 'Affiliation': '448249 Department of Cardiovascular Surgery, Ankara City Hospital, Turkey.'}, {'ForeName': 'Mehmet Ali', 'Initials': 'MA', 'LastName': 'Onur', 'Affiliation': '198375 Faculty of Science, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Kanat', 'Initials': 'K', 'LastName': 'Ozisik', 'Affiliation': '448249 Department of Cardiovascular Surgery, Ankara City Hospital, Turkey.'}]","Innovations (Philadelphia, Pa.)",['10.1177/1556984520967119']
2182,33155968,[Direct Oral Anticoagulant Edoxaban in Patients with Non-Valvular Atrial Fibrillation: Results of Direct Comparison with Warfarin].,"This review analyzes results of a large prospective, randomized, double-blind, placebo-controlled clinical study ENGAGE AF-TIMI 48 that compared efficacy and safety of warfarin, a vitamin K antagonist, and edoxaban, an oral inhibitor of activated coagulation factor X. The review addresses important practical aspects of using edoxaban in patients with nonvalvular atrial fibrillation.",2020,The review addresses important practical aspects of using edoxaban in patients with nonvalvular atrial fibrillation.,"['patients with nonvalvular atrial fibrillation', 'Patients with Non-Valvular Atrial Fibrillation']","['Warfarin', 'edoxaban', 'placebo', 'warfarin, a vitamin K antagonist, and edoxaban', 'Direct Oral Anticoagulant Edoxaban']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]",[],,0.0971996,The review addresses important practical aspects of using edoxaban in patients with nonvalvular atrial fibrillation.,"[{'ForeName': 'I S', 'Initials': 'IS', 'LastName': 'Yavelov', 'Affiliation': '""National Medical Research Center for Therapy and Preventive Medicine"" of the Ministry of Health of Russia, Moscow.'}]",Kardiologiia,['10.18087/cardio.2020.8.n1244']
2183,33152029,Comparison of bispectral index-guided and fixed-gas concentration techniques in desflurane and remifentanil anesthesia: A randomized controlled trial.,"Anesthesia with desflurane and remifentanil can be maintained with either fixed or titrated desflurane concentration. We hypothesized that the fixed-gas concentration (FG) method would reduce the number of anesthetic titrations without hypnotic and hemodynamic instability compared to the bispectral index (BIS)-guided (BG) method. Forty-eight patients were randomly allocated to the FG or BG groups. In the FG group, desflurane vaporizer setting was fixed at 1 age-corrected minimum alveolar concentration (MAC). In the BG group, desflurane was titrated to target a BIS level at 50. Remifentanil was titrated to maintain a systolic arterial pressure (SAP) of 120 mmHg in both groups. Our primary endpoint was the hypnotic stability measured by the wobble of BIS in performance analysis, and the secondary endpoints included the wobble of SAP, mean BIS value during surgery, and the number of anesthetic titrations. The BIS in the FG group showed significantly less wobble (3.9 ± 1.1% vs 5.5 ± 1.5%, P <0.001) but lower value (33 ± 6 vs 46 ± 7, P <0.001) than BG group. The wobble of SAP showed no difference between groups [median (inter-quartile range), 5.0 (4.1-7.5)% vs 5.2 (4.2-8.3)%, P = 0.557]. The numbers of anesthetic titrations in the FG group were significantly lower than the BG group (0 ± 0 vs 8 ± 5, P<0.001 for desflurane, 13 ± 13 vs 22 ± 17, P = 0.047 for remifentanil). Less wobble in BIS and reduced anesthetic titration without hemodynamic instability during the FG technique may be practical in balanced anesthesia using desflurane and remifentanil anesthesia. Clinical trial: This study was registered at ClinicalTrials.gov (NCT02283866).",2020,"The numbers of anesthetic titrations in the FG group were significantly lower than the BG group (0 ± 0 vs 8 ± 5, P<0.001 for desflurane, 13 ± 13 vs 22 ± 17, P = 0.047 for remifentanil).",['Forty-eight patients'],"['desflurane and remifentanil', 'desflurane and remifentanil anesthesia', 'Remifentanil', 'bispectral index-guided and fixed-gas concentration techniques', 'desflurane']","['wobble of SAP, mean BIS value during surgery, and the number of anesthetic titrations', 'hypnotic stability', 'systolic arterial pressure (SAP', 'numbers of anesthetic titrations']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",48.0,0.0469589,"The numbers of anesthetic titrations in the FG group were significantly lower than the BG group (0 ± 0 vs 8 ± 5, P<0.001 for desflurane, 13 ± 13 vs 22 ± 17, P = 0.047 for remifentanil).","[{'ForeName': 'Seong Mi', 'Initials': 'SM', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Yoo Sun', 'Initials': 'YS', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Chul-Woo', 'Initials': 'CW', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Won Ho', 'Initials': 'WH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Soo Bin', 'Initials': 'SB', 'LastName': 'Yoon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyung-Chul', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0241828']
2184,33152277,"Internal mammary and medial supraclavicular lymph node chain irradiation in stage I-III breast cancer (EORTC 22922/10925): 15-year results of a randomised, phase 3 trial.","BACKGROUND
10-year results from several studies showed improved disease-free survival and distant metastasis-free survival, reduced breast cancer-related mortality, and variable effects on overall survival with the addition of partial or comprehensive regional lymph node irradiation after surgery in patients with breast cancer. We present the scheduled 15-year analysis of the European Organisation for Research and Treatment of Cancer (EORTC) 22922/10925 trial, which aims to investigate the impact on overall survival of elective internal mammary and medial supraclavicular (IM-MS) irradiation.
METHODS
EORTC 22922/10925, a randomised, phase 3 trial done across 46 radiation oncology departments from 13 countries, included women up to 75 years of age with unilateral, histologically confirmed, stage I-III breast adenocarcinoma with involved axillary nodes or a central or medially located primary tumour. Surgery consisted of mastectomy or breast-conserving surgery and axillary staging. Patients were randomly assigned (1:1) centrally using minimisation to receive IM-MS irradiation at 50 Gy in 25 fractions (IM-MS irradiation group) or no IM-MS irradiation (control group). Stratification was done for institution, menopausal status, site of the primary tumour within the breast, type of breast and axillary surgery, and pathological T and N stage. Patients and investigators were not masked to treatment allocation. The primary endpoint was overall survival analysed according to the intention-to-treat principle. Secondary endpoints were disease-free survival, distant metastasis-free survival, breast cancer mortality, any breast cancer recurrence, and cause of death. Follow-up is ongoing for 20 years after randomisation. This study is registered with ClinicalTrials.gov, NCT00002851.
FINDINGS
Between Aug 5, 1996, and Jan 13, 2004, we enrolled 4004 patients, of whom 2002 were randomly assigned to the IM-MS irradiation group and 2002 to the no IM-MS irradiation group. At a median follow-up of 15·7 years (IQR 14·0-17·6), 554 (27·7%) patients in the IM-MS irradiation group and 569 (28·4%) patients in the control group had died. Overall survival was 73·1% (95% CI 71·0-75·2) in the IM-MS irradiation group and 70·9% (68·6-72·9) in the control group (HR 0·95 [95% CI 0·84-1·06], p=0·36). Any breast cancer recurrence (24·5% [95% CI 22·5-26·6] vs 27·1% [25·1-29·2]; HR 0·87 [95% CI 0·77-0·98], p=0·024) and breast cancer mortality (16·0% [14·3-17·7] vs 19·8% [18·0-21·7]; 0·81 [0·70-0·94], p=0·0055) were lower in the IM-MS irradiation group than in the control group. No significant differences in the IM-MS irradiation group versus the control group were seen for disease-free survival (60·8% [95% CI 58·4-63·2] vs 59·9% [57·5-62·2]; HR 0·93 [95% CI 0·84-1·03], p=0·18), or distant metastasis-free survival (70·0% [67·7-72·2] vs 68·2% [65·9-70·3]; 0·93 [0·83-1·04], p=0·18). Causes of death between groups were similar.
INTERPRETATION
The 15-year results show a significant reduction of breast cancer mortality and any breast cancer recurrence by IM-MS irradiation in stage I-III breast cancer. However, this is not converted to improved overall survival.
FUNDING
US National Cancer Institute, Ligue Nationale contre le Cancer, and KWF Kankerbestrijding.",2020,"No significant differences in the IM-MS irradiation group versus the control group were seen for disease-free survival (60·8% [95% CI 58·4-63·2] vs 59·9% [57·5-62·2]; HR 0·93 [95% CI 0·84-1·03], p=0·18), or distant metastasis-free survival (70·0% [67·7-72·2] vs 68·2% [65·9-70·3]; 0·93 [0·83-1·04], p=0·18).","['I-III breast adenocarcinoma with involved axillary nodes or a central or medially located primary tumour', 'stage I-III breast cancer', 'Between Aug 5, 1996, and Jan 13, 2004, we enrolled 4004 patients', 'stage I-III breast cancer (EORTC 22922/10925', 'patients with breast cancer', '46 radiation oncology departments from 13 countries, included women up to 75 years of age with unilateral, histologically confirmed, stage']","['IM-MS irradiation group and 2002 to the no IM-MS irradiation group', 'IM-MS irradiation', 'elective internal mammary and medial supraclavicular (IM-MS) irradiation', 'Internal mammary and medial supraclavicular lymph node chain irradiation', 'IM-MS irradiation at 50 Gy in 25 fractions (IM-MS irradiation group) or no IM-MS irradiation (control group', 'Surgery consisted of mastectomy or breast-conserving surgery and axillary staging']","['overall survival', 'Overall survival', 'Cancer (EORTC', 'breast cancer mortality', 'breast cancer recurrence', 'breast cancer mortality and any breast cancer recurrence', 'disease-free survival', 'distant metastasis-free survival', 'died', 'disease-free survival and distant metastasis-free survival, reduced breast cancer-related mortality', 'disease-free survival, distant metastasis-free survival, breast cancer mortality, any breast cancer recurrence, and cause of death']","[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0858252', 'cui_str': 'Breast adenocarcinoma'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0243005', 'cui_str': 'Radiation oncology'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0229730', 'cui_str': 'Structure of supraclavicular lymph node'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0332305', 'cui_str': 'With staging'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",4004.0,0.270225,"No significant differences in the IM-MS irradiation group versus the control group were seen for disease-free survival (60·8% [95% CI 58·4-63·2] vs 59·9% [57·5-62·2]; HR 0·93 [95% CI 0·84-1·03], p=0·18), or distant metastasis-free survival (70·0% [67·7-72·2] vs 68·2% [65·9-70·3]; 0·93 [0·83-1·04], p=0·18).","[{'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Poortmans', 'Affiliation': 'Department of Radiation Oncology, Iridium Kankernetwerk, Wilrijk-Antwerp, Belgium; Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk-Antwerp, Belgium. Electronic address: philip.poortmans@telenet.be.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Weltens', 'Affiliation': 'Department of Radiation Oncology, University Hospital Leuven, Leuven, Belgium; Department of Oncology, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Fortpied', 'Affiliation': 'European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Kirkove', 'Affiliation': 'Department of Radiation Oncology, University Hospital Saint Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Peignaux-Casasnovas', 'Affiliation': 'Department of Radiation Oncology, Centre Georges François Leclerc, Dijon, France.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Budach', 'Affiliation': 'Department of Radiation Oncology and Radiotherapy, Comprehensive Cancer Center, Charite University Medicine, Berlin, Germany.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'van der Leij', 'Affiliation': 'Department of Radiation Oncology, University Medical Centre Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Vonk', 'Affiliation': 'Radiotherapiegroep, Deventer, Netherlands.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Weidner', 'Affiliation': 'Department of Radiation Oncology, University Hospital, Tübingen, Germany.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Rivera', 'Affiliation': 'Department of Radiation Oncology, Gustave Roussy Cancer Centre, Villejuif, France.'}, {'ForeName': 'Geertjan', 'Initials': 'G', 'LastName': 'van Tienhoven', 'Affiliation': 'Department of Radiation Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Netherlands.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Fourquet', 'Affiliation': 'Department of Radiation Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Noel', 'Affiliation': 'Department of Radiation Oncology, Institut de Cancérologie Strasbourg-Europe, Strasbourg, France.'}, {'ForeName': 'Mariacarla', 'Initials': 'M', 'LastName': 'Valli', 'Affiliation': 'Department of Radiation Oncology, Sant Anna Hospital, Como, Italy.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Guckenberger', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Eveline', 'Initials': 'E', 'LastName': 'Koiter', 'Affiliation': 'Department of Radiation Oncology, Medisch Spectrum Twente, Enschede, Netherlands.'}, {'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Racadot', 'Affiliation': 'Department of Radiation Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Roxolyana', 'Initials': 'R', 'LastName': 'Abdah-Bortnyak', 'Affiliation': 'Department of Radiation Oncology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Erik F', 'Initials': 'EF', 'LastName': 'Van Limbergen', 'Affiliation': 'Department of Radiation Oncology, University Hospital Leuven, Leuven, Belgium; Department of Oncology, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Engelen', 'Affiliation': 'Department of Radiation Oncology, Institute Verbeeten, Tilburg, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'De Brouwer', 'Affiliation': 'Department of Radiation Oncology, Institute Verbeeten, Tilburg, Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Struikmans', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Bartelink', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30472-1']
2185,33152284,"Long-term outcome and prognostic value of Ki67 after perioperative endocrine therapy in postmenopausal women with hormone-sensitive early breast cancer (POETIC): an open-label, multicentre, parallel-group, randomised, phase 3 trial.","BACKGROUND
Preoperative and perioperative aromatase inhibitor (POAI) therapy has the potential to improve outcomes in women with operable oestrogen receptor-positive primary breast cancer. It has also been suggested that tumour Ki67 values after 2 weeks (Ki67 2W ) of POAI predicts individual patient outcome better than baseline Ki67 (Ki67 B ). The POETIC trial aimed to test these two hypotheses.
METHODS
POETIC was an open-label, multicentre, parallel-group, randomised, phase 3 trial (done in 130 UK hospitals) in which postmenopausal women aged at least 50 years with WHO performance status 0-1 and hormone receptor-positive, operable breast cancer were randomly assigned (2:1) to POAI (letrozole 2·5 mg per day orally or anastrozole 1 mg per day orally) for 14 days before and following surgery or no POAI (control). Adjuvant treatment was given as per UK standard local practice. Randomisation was done centrally by computer-generated permuted block method (variable block size of six or nine) and was stratified by hospital. Treatment allocation was not masked. The primary endpoint was time to recurrence. A key second objective explored association between Ki67 (dichotomised at 10%) and disease outcomes. The primary analysis for clinical endpoints was by modified intention to treat (excluding patients who withdrew consent). For Ki67 biomarker association and endpoint analysis, the evaluable population included all randomly assigned patients who had paired Ki67 values available. This study is registered with ClinicalTrials.gov, NCT02338310; the European Clinical Trials database, EudraCT2007-003877-21; and the ISRCTN registry, ISRCTN63882543. Recruitment is complete and long-term follow-up is ongoing.
FINDINGS
Between Oct 13, 2008, and April 16, 2014, 4480 women were recruited and randomly assigned to POAI (n=2976) or control (n=1504). On Feb 6, 2018, median follow-up was 62·9 months (IQR 58·1-74·1). 434 (10%) of 4480 women had a breast cancer recurrence (280 [9%] POAI; 154 [10%] control), hazard ratio 0·92 (95% CI 0·75-1·12); p=0·40 with the proportion free from breast cancer recurrence at 5 years of 91·0% (95% CI 89·9-92·0) for patients in the POAI group and 90·4% (88·7-91·9) in the control group. Within the POAI-treated HER2-negative subpopulation, 5-year recurrence risk in women with low Ki67 B and Ki67 2W (low-low) was 4·3% (95% CI 2·9-6·3), 8·4% (6·8-10·5) with high Ki67 B and low Ki67 2W (high-low) and 21·5% (17·1-27·0) with high Ki67 B and Ki67 2W (high-high). Within the POAI-treated HER2-positive subpopulation, 5-year recurrence risk in the low-low group was 10·1% (95% CI 3·2-31·3), 7·7% (3·4-17·5) in the high-low group, and 15·7% (10·1-24·4) in the high-high group. The most commonly reported grade 3 adverse events were hot flushes (20 [1%] of 2801 patients in the POAI group vs six [<1%] of 1400 in the control group) and musculoskeletal pain (29 [1%] vs 13 [1%]). No treatment-related deaths were reported.
INTERPRETATION
POAI has not been shown to improve treatment outcome, but can be used without detriment to help select appropriate adjuvant therapy based on tumour Ki67. Most patients with low Ki67 B or low POAI-induced Ki67 2W do well with adjuvant standard endocrine therapy (giving consideration to clinical-pathological factors), whereas those whose POAI-induced Ki67 2W remains high might benefit from further adjuvant treatment or trials of new therapies.
FUNDING
Cancer Research UK.",2020,"POAI; 154 [10%] control), hazard ratio 0·92 (95% CI 0·75-1·12); p=0·40 with the proportion free from breast cancer recurrence at 5 years of 91·0% (95% CI 89·9-92·0) for patients in the POAI group and 90·4% (88·7-91·9) in the control group.","['postmenopausal women with hormone-sensitive early breast cancer (POETIC', '130 UK hospitals) in which postmenopausal women aged at least 50 years with WHO performance status 0-1 and hormone receptor-positive, operable breast cancer', 'Between Oct 13, 2008, and April 16, 2014, 4480', '4480 women had a breast cancer recurrence (280 [9', 'women with operable oestrogen receptor-positive primary breast cancer']","['letrozole 2·5 mg per day orally or anastrozole', 'POAI ', 'POAI) therapy', 'POAI', 'perioperative aromatase inhibitor', 'perioperative endocrine therapy']","['musculoskeletal pain', '5-year recurrence risk', 'time to recurrence', 'breast cancer recurrence', 'grade 3 adverse events']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",4480.0,0.222093,"POAI; 154 [10%] control), hazard ratio 0·92 (95% CI 0·75-1·12); p=0·40 with the proportion free from breast cancer recurrence at 5 years of 91·0% (95% CI 89·9-92·0) for patients in the POAI group and 90·4% (88·7-91·9) in the control group.","[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Smith', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK; The Institute of Cancer Research, London, UK. Electronic address: poetic-icrctsu@icr.ac.uk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Robertson', 'Affiliation': 'University of Nottingham, Nottingham, UK; University Hospitals of Derby and Burton, Derby, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Kilburn', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Wilcox', 'Affiliation': 'Independent Cancer Patients Voice, London, UK.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Evans', 'Affiliation': 'Poole Hospital NHS Foundation Trust, Poole, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Holcombe', 'Affiliation': 'Liverpool University Hospitals Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Horgan', 'Affiliation': 'Bexley Cancer Centre, Leeds, UK.'}, {'ForeName': 'Cliona', 'Initials': 'C', 'LastName': 'Kirwan', 'Affiliation': 'University of Manchester and Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mallon', 'Affiliation': 'Queen Elizabeth University Hospital Glasgow, Govan, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sibbering', 'Affiliation': 'University Hospitals of Derby and Burton, Derby, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Skene', 'Affiliation': 'Royal Bournemouth and Christchurch NHS Foundation Trust, Bournemouth, UK.'}, {'ForeName': 'Raghavan', 'Initials': 'R', 'LastName': 'Vidya', 'Affiliation': 'University of Birmingham and Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Cheang', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Banerji', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Morden', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Kally', 'Initials': 'K', 'LastName': 'Sidhu', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dodson', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Bliss', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Dowsett', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK; The Institute of Cancer Research, London, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30458-7']
2186,33152285,A multivariable prognostic score to guide systemic therapy in early-stage HER2-positive breast cancer: a retrospective study with an external evaluation.,"BACKGROUND
In early-stage HER2-positive breast cancer, escalation or de-escalation of systemic therapy is a controversial topic. As an aid to treatment decisions, we aimed to develop a prognostic assay that integrates multiple data types for predicting survival outcome in patients with newly diagnosed HER2-positive breast cancer.
METHODS
We derived a combined prognostic model using retrospective clinical-pathological data on stromal tumour-infiltrating lymphocytes, PAM50 subtypes, and expression of 55 genes obtained from patients who participated in the Short-HER phase 3 trial. The trial enrolled patients with newly diagnosed, node-positive, HER2-positive breast cancer or, if node negative, with at least one risk factor (ie, tumour size >2 cm, histological grade 3, lymphovascular invasion, Ki67 >20%, age ≤35 years, or hormone receptor negativity), and randomly assigned them to adjuvant anthracycline plus taxane-based combinations with either 9 weeks or 1 year of trastuzumab. Trastuzumab was administered intravenously every 3 weeks (8 mg/kg loading dose at first cycle, and 6 mg/kg thereafter) for 18 doses or weekly (4 mg/kg loading dose in the first week, and 2 mg/kg thereafter) for 9 weeks, starting concomitantly with the first taxane dose. Median follow-up was 91·4 months (IQR 75·1-105·6). The primary objective of our study was to derive and evaluate a combined prognostic score associated with distant metastasis-free survival (the time between randomisation and distant recurrence or death before recurrence), an exploratory endpoint in Short-HER. Patient samples in the training dataset were split into a training set (n=290) and a testing set (n=145), balancing for event and treatment group. The training set was further stratified into 100 iterations of Monte-Carlo cross validation (MCCV). Cox proportional hazard models were fit to MCCV training samples using Elastic-Net. A maximum of 92 features were assessed. The final prognostic model was evaluated in an independent combined dataset of 267 patients with early-stage HER2-positive breast cancer treated with different neoadjuvant and adjuvant anti-HER2-based combinations and from four other studies (PAMELA, CHER-LOB, Hospital Clinic, and Padova) with disease-free survival outcome data.
FINDINGS
From Short-HER, data from 435 (35%) of 1254 patients for tumour size (T1 vs rest), nodal status (N0 vs rest), number of tumour-infiltrating lymphocytes (continuous variable), subtype (HER2-enriched and basal-like vs rest), and 13 genes composed the final model (named HER2DX). HER2DX was significantly associated with distant metastasis-free survival as a continuous variable (p<0·0001). HER2DX median score for quartiles 1-2 was identified as the cutoff to identify low-risk patients; and the score that distinguished quartile 3 from quartile 4 was the cutoff to distinguish medium-risk and high-risk populations. The 5-year distant metastasis-free survival of the low-risk, medium-risk, and high-risk populations were 98·1% (95% CI 96·3-99·9), 88·9% (83·2-95·0), and 73·9% (66·0-82·7), respectively (low-risk vs high-risk hazard ratio [HR] 0·04, 95% CI 0·0-0·1, p<0·0001). In the evaluation cohort, HER2DX was significantly associated with disease-free survival as a continuous variable (HR 2·77, 95% CI 1·4-5·6, p=0·0040) and as group categories (low-risk vs high-risk HR 0·27, 0·1-0·7, p=0·005). 5-year disease-free survival in the HER2DX low-risk group was 93·5% (89·0-98·3%) and in the high-risk group was 81·1% (71·5-92·1).
INTERPRETATION
The HER2DX combined prognostic score identifies patients with early-stage, HER2-positive breast cancer who might be candidates for escalated or de-escalated systemic treatment. Future clinical validation of HER2DX seems warranted to establish its use in different scenarios, especially in the neoadjuvant setting.
FUNDING
Instituto Salud Carlos III, Save the Mama, Pas a Pas, Fundación Científica, Asociación Española Contra el Cáncer, Fundación SEOM, National Institutes of Health, Agenzia Italiana del Farmaco, International Agency for Research on Cancer, and the Veneto Institute of Oncology, and Italian Association for Cancer Research.",2020,HER2DX was significantly associated with distant metastasis-free survival as a continuous variable (p<0·0001).,"['early-stage HER2-positive breast cancer', 'patients with newly diagnosed HER2-positive breast cancer', 'patients who participated in the Short-HER phase 3 trial', 'trial enrolled patients with newly diagnosed, node-positive, HER2-positive breast cancer or, if node negative, with at least one risk factor (ie, tumour size >2 cm, histological grade 3, lymphovascular invasion, Ki67 >20%, age ≤35 years, or hormone receptor negativity', '1254 patients for tumour size', 'patients with early-stage, HER2-positive breast cancer who might be candidates for escalated or de-escalated systemic treatment', '267 patients with early-stage HER2-positive breast cancer treated with different']","['adjuvant anthracycline plus taxane-based combinations with either 9 weeks or 1 year of trastuzumab', 'HER2DX', 'Trastuzumab', 'neoadjuvant and adjuvant anti-HER2-based combinations']","['disease-free survival', 'distant metastasis-free survival', '5-year distant metastasis-free survival of the low-risk, medium-risk, and high-risk populations', 'nodal status (N0 vs rest), number of tumour-infiltrating lymphocytes (continuous variable), subtype (HER2-enriched and basal-like vs rest', '5-year disease-free survival', 'HER2DX median score']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0456201', 'cui_str': 'Histological grades'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0475450', 'cui_str': 'Number of tumors'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",267.0,0.0945389,HER2DX was significantly associated with distant metastasis-free survival as a continuous variable (p<0·0001).,"[{'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain; Department of Medicine, University of Barcelona, Barcelona, Spain. Electronic address: alprat@clinic.cat.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Guarneri', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy; Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padova, Italy.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Paré', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Griguolo', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy; Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padova, Italy.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Pascual', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain; Lineberger Comprehensive Cancer Center, Department of Genetics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Maria V', 'Initials': 'MV', 'LastName': 'Dieci', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy; Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padova, Italy.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Chic', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'González-Farré', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain; Department of Pathology, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Frassoldati', 'Affiliation': 'Clinical Oncology, Department of Morphology, Surgery and Experimental Medicine, S Anna University Hospital, Ferrara, Italy.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Sanfeliu', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain; Department of Pathology, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'Cejalvo', 'Affiliation': 'Department of Medical Oncology, Hospital Clínico Universitario of Valencia, Valencia, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Muñoz', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Bisagni', 'Affiliation': 'Pathology Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Emilia-Romagna, Italy.'}, {'ForeName': 'Fara', 'Initials': 'F', 'LastName': 'Brasó-Maristany', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Urso', 'Affiliation': 'Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padova, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vidal', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.'}, {'ForeName': 'Alba A', 'Initials': 'AA', 'LastName': 'Brandes', 'Affiliation': 'Medical Oncology, Azienda Unità Sanitaria Locale di Bologna-IRCCS Istituto delle Scienze Neurologiche, Bologna.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Adamo', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Musolino', 'Affiliation': 'Department of Medicine and Surgery, and the Medical Oncology and Breast Unit, University Hospital of Parma, Piacenza, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Miglietta', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy; Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padova, Italy.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Conte', 'Affiliation': 'Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Vall d'Hebron University Hospital; Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Vall d'Hebron University Hospital; Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Sònia', 'Initials': 'S', 'LastName': 'Pernas', 'Affiliation': ""SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Institut Català d'Oncologia Hospitalet, Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Alarcón', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Hospital Universitario Son Espases, Carretera de Valldemossa, Palma de Mallorca, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Llombart-Cussac', 'Affiliation': 'Department of Medical Oncology, Hospital Arnau de Vilanova, Valencia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron University Hospital; Vall d'Hebron Institute of Oncology, Barcelona, Spain; IOB Institute of Oncology, Quiron Group, Barcelona, Spain.""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Manso', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'López', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Complejo Universitario de Santiago de Compostela-CIBERONC, Santiago de Compostela, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Schettini', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain; Department of Medical Oncology, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Villagrasa', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': 'Lineberger Comprehensive Cancer Center, Department of Genetics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Perou', 'Affiliation': 'Lineberger Comprehensive Cancer Center, Department of Genetics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Piacentini', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy; Center for Genome Research, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Tagliafico', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy; Center for Genome Research, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Parker', 'Affiliation': 'Lineberger Comprehensive Cancer Center, Department of Genetics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Pierfranco', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy; Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padova, Italy; Department of Medical Oncology UO Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Genova, Italy.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30450-2']
2187,33152288,Results from the PROPHYLOCHIP-PRODIGE 15 trial.,,2020,,[],[],[],[],[],[],,0.0490051,,"[{'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Tanis', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Centre Amsterdam, 1100 DD Amsterdam, Netherlands. Electronic address: p.j.tanis@amsterdamumc.nl.'}, {'ForeName': 'Jurriaan B', 'Initials': 'JB', 'LastName': 'Tuynman', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Centre Amsterdam, 1100 DD Amsterdam, Netherlands.'}, {'ForeName': 'Ignace H J T', 'Initials': 'IHJT', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Catharina Cancer Institute, Eindhoven, Netherlands; School for Oncology and Developmental Biology, Maastricht University, Maastricht, Netherlands.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30497-6']
2188,33152289,Results from the PROPHYLOCHIP-PRODIGE 15 trial.,,2020,,[],[],[],[],[],[],,0.0490051,,"[{'ForeName': 'Swapnil', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Colorectal Division, Department of Gastrointestinal and Hepatobiliary Surgery, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India 400012.'}, {'ForeName': 'Diwakar', 'Initials': 'D', 'LastName': 'Pandey', 'Affiliation': 'Colorectal Division, Department of Gastrointestinal and Hepatobiliary Surgery, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India 400012.'}, {'ForeName': 'Avanish', 'Initials': 'A', 'LastName': 'Saklani', 'Affiliation': 'Colorectal Division, Department of Gastrointestinal and Hepatobiliary Surgery, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India 400012. Electronic address: asaklani@hotmail.com.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30624-0']
2189,33152314,The effects of a combined intervention (DHA supplementation and home-based dietary counseling) on metabolic control in obese and overweight pregnant women: the MIGHT study.,"BACKGROUND
Lifestyle interventions have shown limited effectiveness in the prevention of gestational diabetes mellitus (GDM). The combination of lifestyle interventions with omega-3 polyunsaturated fatty acid (PUFA) supplementation could have a synergetic effect on maternal and offspring outcomes. This joint intervention has not been previously evaluated.
OBJECTIVE
We evaluated the effects of docosahexaenoic acid (DHA) supplementation among obese and overweight pregnant women (independently or combined with a dietary counseling intervention) on metabolic control in mothers and their offspring.
STUDY DESIGN
Randomized controlled trial, 2×2 factorial design. The inclusion criteria were: <15 weeks of gestation; body mass index >25 kg/m 2 at the first prenatal visit; singleton pregnancy; and 18 years of age or older. The recruited women (n= 1,002) were randomly allocated to one of the four parallel groups: Group 1: dietary counseling + 800 mg/day of DHA (n= 250); Group 2: routine counseling + 800 mg/day DHA (n= 252); Group 3: dietary counseling + 200 mg/day DHA (n= 249); and Group 4: routine counseling + 200 mg/day DHA (n= 251) considered as the reference group. The dietary intervention comprised three sessions, and it was focused on reducing the consumption of foods that most contributed to daily sugar intake. Primary outcomes were GDM defined according to the national guidelines; macrosomia (birth weight > 4,000 g); and neonatal insulin resistance (cord blood HOMA-IR > 2.60), which was assessed in a subsample of 226 newborns. The analysis was by intention to treat and by efficacy.
TRIAL REGISTRATION
NCT02574767.
RESULTS
The overall incidence of GDM was 20.2% (Group 1: 21.0%, Group 2: 20.1%, Group 3: 18.9%, and Group 4: 20.9%). Mean birth weight was 3403.0 g (SD 575.3), and the incidence of macrosomia was 11.9% (Group 1: 13.2%, Group 2: 10.8%, Group 3: 11.5%, and Group 4: 12.1%). Median cord blood HOMA-IR was 0.9 (IQR 0.6-1.7), and 10.2% showed cord blood insulin resistance (Group 1: 12.0%, Group 2: 12.0%, Group 3: 9.7%, and Group 4: 5.1%). No significant differences were found among groups regarding primary outcomes (p< 0.05). Glucose concentrations in the cord blood samples were lower in those adherents to the DHA supplementation (p< 0.05).
CONCLUSIONS
For women who were overweight or obese at the beginning of pregnancy, this combined intervention did not reduce the risk of gestational diabetes in mothers or macrosomia and insulin resistance in neonates.",2020,"Glucose concentrations in the cord blood samples were lower in those adherents to the DHA supplementation (p< 0.05).
","['obese and overweight pregnant women', 'gestational diabetes mellitus (GDM', 'women who were overweight or obese at the beginning of pregnancy', 'recruited women (n= 1,002', 'mothers and their offspring', 'The inclusion criteria were: <15 weeks of gestation; body mass index >25 kg/m 2 at the first prenatal visit; singleton pregnancy; and 18 years of age or older']","['dietary counseling + 800 mg/day of DHA', 'docosahexaenoic acid (DHA) supplementation', 'routine counseling + 800 mg/day DHA', 'omega-3 polyunsaturated fatty acid (PUFA) supplementation', 'dietary counseling + 200 mg/day DHA (n= 249); and Group 4: routine counseling + 200 mg/day DHA', 'combined intervention (DHA supplementation and home-based dietary counseling', 'dietary counseling intervention']","['incidence of macrosomia', 'overall incidence of GDM', 'cord blood insulin resistance', 'GDM defined according to the national guidelines; macrosomia (birth weight > 4,000 g); and neonatal insulin resistance (cord blood HOMA-IR > 2.60', 'Mean birth weight', 'Median cord blood HOMA-IR', 'risk of gestational diabetes', 'Glucose concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C1827763', 'cui_str': 'Prenatal visit'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0556102', 'cui_str': 'Docosahexaenoic acid supplementation'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}]",,0.0905679,"Glucose concentrations in the cord blood samples were lower in those adherents to the DHA supplementation (p< 0.05).
","[{'ForeName': 'María L', 'Initials': 'ML', 'LastName': 'Garmendia', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Santiago, Chile. Electronic address: mgarmendia@inta.uchile.cl.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Casanello', 'Affiliation': 'Department of Pediatrics, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile; Division of Obstetrics and Gynecology, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Flores', 'Affiliation': 'Health Area of Puente Alto County, Santiago, Chile.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Kusanovic', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile; Center for Research and Innovation in Maternal-Fetal Medicine (CIMAF), Department of Obstetrics and Gynecology, Sótero del Río Hospital, Santiago, Chile.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Uauy', 'Affiliation': 'Department of Pediatrics, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.10.048']
2190,33152688,Acute Impact of the Use of a Standing Desk on Appetite Sensations and Energy Intake.,"BACKGROUND
Sedentariness has been shown to increase energy intake and is associated with increased obesity prevalence. Active workstations are used to implement physical activity interventions in workplaces, but it is unclear if they can lead to reductions in body weight. This study aims to observe the acute impact of a standing desk on energy intake and appetite sensations.
METHODS
Participants came to the laboratory, where they were randomly assigned to a seated or a standing desk. They completed a work session (∼75 min) during which they performed cognitive tasks and reported their levels of stress. Following this, they had a 15-minute break during which buffet-type snacks were served. Subjects were asked to rate their appetite sensations on visual analog scales.
RESULTS
Thirty-six normal-weight men and women aged 24.3 (4.3) years participated in this study. Energy intake from snacks was similar (P = .472) between participants who sat (427.8 [286.9] kcal) and the ones who stood (461.2 [272.8] kcal) during the work session. There was no difference in satiety quotients around the snack and no significant interaction time × condition for appetite sensations.
CONCLUSION
The use of a standing desk for 75 minutes did not increase food consumption following a meal.",2020,There was no difference in satiety quotients around the snack and no significant interaction time,"['Thirty-six normal-weight men and women aged 24.3 (4.3)\xa0years participated in this study', 'Participants came to the laboratory']",['Standing Desk'],"['Appetite Sensations and Energy Intake', 'rate their appetite sensations on visual analog scales', 'satiety quotients', 'interaction time', 'food consumption']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.116091,There was no difference in satiety quotients around the snack and no significant interaction time,"[{'ForeName': 'Kapria-Jad', 'Initials': 'KJ', 'LastName': 'Josaphat', 'Affiliation': ''}, {'ForeName': 'Élise', 'Initials': 'É', 'LastName': 'Labonté-Lemoyne', 'Affiliation': ''}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Sénécal', 'Affiliation': ''}, {'ForeName': 'Pierre-Majorique', 'Initials': 'PM', 'LastName': 'Léger', 'Affiliation': ''}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Mathieu', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0444']
2191,33152692,Early Physical Activity Adoption Predicts Longer-Term Physical Activity Among Individuals Inactive at Baseline.,"BACKGROUND
To examine the relationship between early physical activity (PA) adoption (2, 3, and 4 mo) and longer-term PA adherence (1 y) among individuals who were inactive at baseline and received a lifestyle intervention.
METHODS
Participants (n = 637) received weekly behavioral weight loss sessions, calorie reduction, and PA goals (50-175 min/wk progression). PA was assessed via self-reported measures at baseline, months 2 to 4, and 1 year.
RESULTS
PA at months 2 to 4 was significantly correlated with PA at 1 year (rs = .29-.35, P < .01). At all early time points, those failing to meet the prescribed PA goal (early nonadopters) engaged in significantly less PA at 1 year than those meeting the early PA goal (initial adopters). For example, using 2-month criteria, initial adopters engaged in 108.3 minutes per week more at 1 year compared with early nonadopters (P < .01) and had 2.8 times the odds (95% confidence interval, 1.9-4.2) of meeting the 1-year PA goal (≥175 min/wk, P < .01).
CONCLUSIONS
Failure to achieve PA goals at 2, 3, or 4 months results in less overall PA at 1 year. Thus, PA observed as early as month 2 may be a useful indicator for identifying at-risk individuals who may benefit from more intensive PA intervention strategies.",2020,"RESULTS
PA at months 2 to 4 was significantly correlated with PA at 1 year (rs = .29-.35, P < .01).",['Participants (n = 637) received'],"['weekly behavioral weight loss sessions, calorie reduction, and PA goals', 'lifestyle intervention']","['1-year PA goal', 'Longer-Term Physical Activity']",[],"[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",,0.0419941,"RESULTS
PA at months 2 to 4 was significantly correlated with PA at 1 year (rs = .29-.35, P < .01).","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Unick', 'Affiliation': ''}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Walkup', 'Affiliation': ''}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': ''}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Brubaker', 'Affiliation': ''}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': ''}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': ''}, {'ForeName': 'Roeland J W', 'Initials': 'RJW', 'LastName': 'Middelbeek', 'Affiliation': ''}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'West', 'Affiliation': ''}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2020-0114']
2192,33152697,Lessons From Adaptive Randomization: Spying the I-SPY2 Trial in Breast Cancer.,,2020,,['Breast Cancer'],[],[],"[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",[],[],,0.037732,,"[{'ForeName': 'Bishal', 'Initials': 'B', 'LastName': 'Gyawali', 'Affiliation': ''}, {'ForeName': 'Saroj', 'Initials': 'S', 'LastName': 'Niraula', 'Affiliation': ''}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2020.7648']
2193,33152708,Cost-Effectiveness of Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer.,"BACKGROUND
Maintenance therapy with the PARP inhibitor olaparib for metastatic pancreatic cancer (MPC) with a germline BRCA1 or BRCA2 mutation has been shown to be effective. We aimed to evaluate the cost-effectiveness of maintenance olaparib for MPC from the US payer perspective.
MATERIALS AND METHODS
A partitioned survival model was adopted to project the disease course of MPC. Efficacy and toxicity data were gathered from the Pancreas Cancer Olaparib Ongoing (POLO) trial. Transition probabilities were estimated from the reported survival probabilities in each POLO group. Cost and health preference data were derived from the literature. The incremental cost-utility ratio, incremental net-health benefit, and incremental monetary benefit were measured. Subgroup analysis, one-way analysis, and probabilistic sensitivity analysis were performed to explore the model uncertainties.
RESULTS
Maintenance olaparib had an incremental cost-utility ratio of $191,596 per additional progression-free survival (PFS) quality-adjusted life-year (QALY) gained, with a high cost of $132,287 and 0.691 PFS QALY gained, compared with results for a placebo. Subgroup analysis indicated that maintenance olaparib achieved at least a 16.8% probability of cost-effectiveness at the threshold of $200,000/QALY. One-way sensitivity analyses revealed that the results were sensitive to the hazard ratio of PFS and the cost of olaparib. When overall survival was considered, maintenance olaparib had an incremental cost-utility ratio of $265,290 per additional QALY gained, with a high cost of $128,266 and 0.483 QALY gained, compared with results for a placebo.
CONCLUSIONS
Maintenance olaparib is potentially cost-effective compared with placebo for patients with a germline BRCA mutation and MPC. Economic outcomes could be improved by tailoring treatment based on individual patient factors.",2020,"Subgroup analysis indicated that maintenance olaparib achieved at least a 16.8% probability of cost-effectiveness at the threshold of $200,000/QALY.","['patients with a germline BRCA mutation and MPC', 'metastatic pancreatic cancer (MPC', 'Germline BRCA-Mutated Metastatic Pancreatic Cancer']","['PARP inhibitor olaparib', 'placebo', 'Maintenance Olaparib']","['cost-effectiveness', 'incremental cost-utility ratio of $191,596 per additional progression-free survival (PFS) quality-adjusted life-year (QALY', 'incremental cost-utility ratio, incremental net-health benefit, and incremental monetary benefit', 'Transition probabilities', 'survival probabilities', 'hazard ratio of PFS and the cost of olaparib', 'Efficacy and toxicity data', 'incremental cost-utility ratio', 'Cost and health preference data', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}]","[{'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.129863,"Subgroup analysis indicated that maintenance olaparib achieved at least a 16.8% probability of cost-effectiveness at the threshold of $200,000/QALY.","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Medical Decision and Economic Group, Department of Pharmacy, Ren Ji Hospital, South Campus, School of Medicine, Shanghai Jiaotong University, Shanghai, China; and.'}, {'ForeName': 'Lizheng', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Global Health Management and Policy, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2020.7587']
2194,33153063,"Manual Material Handling Training: The Effect of Self-Observation, Hetero-Observational and Intrinsic Feedback on Workers' Knowledge and Behaviour.","This study aimed to assess the effect of systematic self-observation, hetero-observational feedback, and feedforward and intrinsic feedback (SsObserWork components) on workers' knowledge and behaviour of a manual material handling (MMH) technique in the industrial sector. Blue-collar workers recruited from a food processing company in Catalonia (Spain) were randomized into SsObserWork ( N = 31) and control ( N = 30) groups. SsObserWork group members participated individually in two sessions and a three-week follow-up between sessions where they received the SsObserWork components. The control group participated individually in two sessions where they received a standard MMH training. An ad hoc instrumentcalled the MMH-SsObserWork instrument was used to assess the MMH behaviour, and an adaption of the instrument was done to assess the workers' knowledge. Significant differences were found between groups for the identification of recommended back positions in the first session and also on comparing both sessions. However, no differences were found for the rest of the criteria. There also were significant differences between groups in the score changes of the back, knee joints, elbow joints, and interaction criterion, indicating that the SsObserWork group improved the MMH performance in these criteria (behaviour). SsObserWork intervention showed a positive effect on improving the knowledge and behaviour of the MMH technique, specifically on back posture.",2020,"There also were significant differences between groups in the score changes of the back, knee joints, elbow joints, and interaction criterion, indicating that the SsObserWork group improved the MMH performance in these criteria (behaviour).",['Blue-collar workers recruited from a food processing company in Catalonia (Spain'],"['standard MMH training', 'Manual Material Handling Training', 'systematic self-observation, hetero-observational feedback, and feedforward and intrinsic feedback (SsObserWork components', 'SsObserWork intervention', 'Self-Observation, Hetero-Observational and Intrinsic Feedback']","['MMH performance', 'knowledge and behaviour of the MMH technique', 'score changes of the back, knee joints, elbow joints, and interaction criterion']","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0016487', 'cui_str': 'Food Processing'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0013770', 'cui_str': 'Elbow joint structure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",,0.0189754,"There also were significant differences between groups in the score changes of the back, knee joints, elbow joints, and interaction criterion, indicating that the SsObserWork group improved the MMH performance in these criteria (behaviour).","[{'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Sene-Mir', 'Affiliation': 'Physical Activity and Sports Studies Centre, University of Vic-Central University of Catalonia, 08500 Vic, Barcelona, Spain.'}, {'ForeName': 'Mariona', 'Initials': 'M', 'LastName': 'Portell', 'Affiliation': 'Department of Psychobiology and Methodology in Health Sciences, Universitat Autònoma de Barcelona, Cerdanyola del Vallès, 08193 Barcelona, Spain.'}, {'ForeName': 'M Teresa', 'Initials': 'MT', 'LastName': 'Anguera', 'Affiliation': 'Faculty of Psychology, Institute of Neurosciences, University of Barcelona, 08035 Barcelona, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Chacón-Moscoso', 'Affiliation': 'Departamento de Psicología Experimental, Universidad de Sevilla, 41018 Seville, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17218095']
2195,33153145,Wearing of Cloth or Disposable Surgical Face Masks has no Effect on Vigorous Exercise Performance in Healthy Individuals.,"Wearing face masks is recommended for the prevention of contracting or exposing others to cardiorespiratory infections, such as COVID-19. Controversy exists on whether wearing face masks during vigorous exercise affects performance. We used a randomized, counterbalanced cross-over design to evaluate the effects of wearing a surgical mask, a cloth mask, or no mask in 14 participants (7 men and 7 women; 28.2 ± 8.7 y) during a cycle ergometry test to exhaustion. Arterial oxygen saturation (pulse oximetry) and tissue oxygenation index (indicator of hemoglobin saturation/desaturation) at vastus lateralis (near-infrared spectroscopy) were assessed throughout the exercise tests. Wearing face masks had no effect on performance (time to exhaustion (mean ± SD): no mask 622 ± 141 s, surgical mask 657 ± 158 s, cloth mask 637 ± 153 s ( p = 0.20); peak power: no mask 234 ± 56 W, surgical mask 241 ± 57 W, cloth mask 241 ± 51 W ( p = 0.49)). When expressed relative to peak exercise performance, no differences were evident between wearing or not wearing a mask for arterial oxygen saturation, tissue oxygenation index, rating of perceived exertion, or heart rate at any time during the exercise tests. Wearing a face mask during vigorous exercise had no discernable detrimental effect on blood or muscle oxygenation, and exercise performance in young, healthy participants (ClinicalTrials.gov, NCT04557605).",2020,"Wearing a face mask during vigorous exercise had no discernable detrimental effect on blood or muscle oxygenation, and exercise performance in young, healthy participants (ClinicalTrials.gov, NCT04557605).","['14 participants (7 men and 7 women; 28.2 ± 8.7 y) during a cycle ergometry test to exhaustion', 'young, healthy participants (ClinicalTrials.gov, NCT04557605', 'Healthy Individuals']","['wearing a surgical mask, a cloth mask, or no mask']","['blood or muscle oxygenation, and exercise performance', 'wearing or not wearing a mask for arterial oxygen saturation, tissue oxygenation index, rating of perceived exertion, or heart rate', 'Vigorous Exercise Performance', 'peak exercise performance', 'Arterial oxygen saturation (pulse oximetry) and tissue oxygenation index (indicator of hemoglobin saturation/desaturation']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0181758', 'cui_str': 'Surgical face mask'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}]",,0.0295021,"Wearing a face mask during vigorous exercise had no discernable detrimental effect on blood or muscle oxygenation, and exercise performance in young, healthy participants (ClinicalTrials.gov, NCT04557605).","[{'ForeName': 'Keely', 'Initials': 'K', 'LastName': 'Shaw', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK S7N 5B2, Canada.'}, {'ForeName': 'Scotty', 'Initials': 'S', 'LastName': 'Butcher', 'Affiliation': 'School of Rehabilitation Science, University of Saskatchewan, Saskatoon, SK S7N 2Z4, Canada.'}, {'ForeName': 'Jongbum', 'Initials': 'J', 'LastName': 'Ko', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK S7N 5B2, Canada.'}, {'ForeName': 'Gordon A', 'Initials': 'GA', 'LastName': 'Zello', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK S7N 5E5, Canada.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Chilibeck', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK S7N 5B2, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17218110']
2196,33153191,"Safety and Immunogenicity of the GamTBvac, the Recombinant Subunit Tuberculosis Vaccine Candidate: A Phase II, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study.","GamTBvac is a candidate tuberculosis vaccine with two fusion proteins, containing Ag85a, ESAT6, CFP10, and a dextran-binding domain (DBD). Phase II of a double-blind, randomized, multicenter, placebo-controlled study in parallel groups in healthy adults to evaluate the safety and immunogenicity of GamTBvac in 180 previously-vaccinated with Bacillus Calmette-Guérin vaccine (BCG) healthy volunteers without Mycobacterium tuberculosis (MTB) infection was conducted. The dose (0.5 mL) of either the study drug or a placebo was administered subcutaneously twice with an 8-week interval. At eight timepoints from 14 to 150 days, whole blood and sera were assayed. Antigen-specific T-cell responses were measured by an in-house interferon-gamma release assay (IGRA-test), the QuantiFERON (QTF) test, and intracellular cytokine staining (ICS). For antibody response detection, the bead-based multiplex immunoassay (MIA) was applied. The vaccine confirmed an acceptable safety profile previously shown in a first-in-human clinical study. After stimulation with both fusions, the highest median level of INF-γ was detected on day 21. The GamTBvac vaccine induced antigen-specific interferon-gamma release, Th1 cytokine-expressing CD4 + T-cells, and IgG responses and results support further clinical testing of GamTBvac.",2020,"The GamTBvac vaccine induced antigen-specific interferon-gamma release, Th1 cytokine-expressing CD4 + T-cells, and IgG responses and results support further clinical testing of GamTBvac.","['180 previously-vaccinated with Bacillus Calmette-Guérin vaccine (BCG) healthy volunteers without Mycobacterium tuberculosis (MTB) infection was conducted', 'parallel groups in healthy adults']","['Recombinant Subunit Tuberculosis Vaccine Candidate', 'placebo', 'Placebo']","['safety and immunogenicity of GamTBvac', 'Safety and Immunogenicity', 'QuantiFERON (QTF) test, and intracellular cytokine staining (ICS', 'highest median level of INF-γ', 'Antigen-specific T-cell responses']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0041305', 'cui_str': 'Tuberculosis vaccine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0456981', 'cui_str': 'Specific antigen'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",180.0,0.308648,"The GamTBvac vaccine induced antigen-specific interferon-gamma release, Th1 cytokine-expressing CD4 + T-cells, and IgG responses and results support further clinical testing of GamTBvac.","[{'ForeName': 'Artem P', 'Initials': 'AP', 'LastName': 'Tkachuk', 'Affiliation': 'N.F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, 123098 Moscow, Russia.'}, {'ForeName': 'Evgeniia N', 'Initials': 'EN', 'LastName': 'Bykonia', 'Affiliation': 'N.F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, 123098 Moscow, Russia.'}, {'ForeName': 'Liubov I', 'Initials': 'LI', 'LastName': 'Popova', 'Affiliation': 'N.F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, 123098 Moscow, Russia.'}, {'ForeName': 'Denis A', 'Initials': 'DA', 'LastName': 'Kleymenov', 'Affiliation': 'N.F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, 123098 Moscow, Russia.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Semashko', 'Affiliation': 'N.F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, 123098 Moscow, Russia.'}, {'ForeName': 'Vladimir P', 'Initials': 'VP', 'LastName': 'Chulanov', 'Affiliation': 'National Medical Research Center for Physiopulmonology and Infectious Diseases, Ministry of Health of the Russian Federation, 127473 Moscow, Russia.'}, {'ForeName': 'Sergey B', 'Initials': 'SB', 'LastName': 'Fitilev', 'Affiliation': 'Department of General and Clinical Pharmacology, RUDN University, 117198 Moscow, Russia.'}, {'ForeName': 'Semyon L', 'Initials': 'SL', 'LastName': 'Maksimov', 'Affiliation': 'Federal State Budgetary Educational Institution of Higher Education A.I. Yevdokimov Moscow State University of Medicine and Dentistry of the Ministry of Healthcare of the Russian Federation, 127473 Moscow, Russia.'}, {'ForeName': 'Elena A', 'Initials': 'EA', 'LastName': 'Smolyarchuk', 'Affiliation': 'The Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of Ministry of Healthcare of the Russian Federation (Sechenovskiy University), 119991 Moscow, Russia.'}, {'ForeName': 'Victor A', 'Initials': 'VA', 'LastName': 'Manuylov', 'Affiliation': 'N.F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, 123098 Moscow, Russia.'}, {'ForeName': 'Daria V', 'Initials': 'DV', 'LastName': 'Vasina', 'Affiliation': 'N.F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, 123098 Moscow, Russia.'}, {'ForeName': 'Vladimir A', 'Initials': 'VA', 'LastName': 'Gushchin', 'Affiliation': 'N.F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, 123098 Moscow, Russia.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Gintsburg', 'Affiliation': 'N.F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, 123098 Moscow, Russia.'}]",Vaccines,['10.3390/vaccines8040652']
2197,33153295,"Response by Zhao et al to Letter Regarding Article, ""Novel Panna Guide Wire Facilitates Percutaneous and Nonfluoroscopic Procedure for Atrial Septal Defect Closure: A Randomized Controlled Trial"".",,2020,,['Atrial Septal Defect Closure'],[],[],"[{'cui': 'C0189965', 'cui_str': 'Atrioseptoplasty'}]",[],[],,0.0408773,,"[{'ForeName': 'Guangzhi', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Pengxu', 'Initials': 'P', 'LastName': 'Kong', 'Affiliation': 'Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiangbin', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.010130']
2198,33153296,"Letter by Ovaert et al Regarding Article, ""Novel Panna Guide Wire Facilitates Percutaneous and Nonfluoroscopic Procedure for Atrial Septal Defect Closure: A Randomized Controlled Trial"".",,2020,,['Atrial Septal Defect Closure'],[],[],"[{'cui': 'C0189965', 'cui_str': 'Atrioseptoplasty'}]",[],[],,0.0582011,,"[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ovaert', 'Affiliation': 'Paediatric and Congenital Cardiology, Timone, AP-HM, Aix-Marseille University, Marseille, France (C.O.).'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Bonnet', 'Affiliation': 'Paediatric and Congenital Cardiology, Hopital Necker-Enfants malades, AP-HP, Université de Paris, France (D.B., S.M.-M.).'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Malekzadeh-Milani', 'Affiliation': 'Paediatric and Congenital Cardiology, Hopital Necker-Enfants malades, AP-HP, Université de Paris, France (D.B., S.M.-M.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.010121']
2199,33153304,"The DURATIONS randomised trial design: Estimation targets, analysis methods and operating characteristics.","BACKGROUND
Designing trials to reduce treatment duration is important in several therapeutic areas, including tuberculosis and bacterial infections. We recently proposed a new randomised trial design to overcome some of the limitations of standard two-arm non-inferiority trials. This DURATIONS design involves randomising patients to a number of duration arms and modelling the so-called 'duration-response curve'. This article investigates the operating characteristics (type-1 and type-2 errors) of different statistical methods of drawing inference from the estimated curve.
METHODS
Our first estimation target is the shortest duration non-inferior to the control (maximum) duration within a specific risk difference margin. We compare different methods of estimating this quantity, including using model confidence bands, the delta method and bootstrap. We then explore the generalisability of results to estimation targets which focus on absolute event rates, risk ratio and gradient of the curve.
RESULTS
We show through simulations that, in most scenarios and for most of the estimation targets, using the bootstrap to estimate variability around the target duration leads to good results for DURATIONS design-appropriate quantities analogous to power and type-1 error. Using model confidence bands is not recommended, while the delta method leads to inflated type-1 error in some scenarios, particularly when the optimal duration is very close to one of the randomised durations.
CONCLUSIONS
Using the bootstrap to estimate the optimal duration in a DURATIONS design has good operating characteristics in a wide range of scenarios and can be used with confidence by researchers wishing to design a DURATIONS trial to reduce treatment duration. Uncertainty around several different targets can be estimated with this bootstrap approach.",2020,"Using model confidence bands is not recommended, while the delta method leads to inflated type-1 error in some scenarios, particularly when the optimal duration is very close to one of the randomised durations.
",[],[],"['absolute event rates, risk ratio and gradient of the curve']",[],[],"[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.101542,"Using model confidence bands is not recommended, while the delta method leads to inflated type-1 error in some scenarios, particularly when the optimal duration is very close to one of the randomised durations.
","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Quartagno', 'Affiliation': 'MRC Clinical Trials Unit, University College London Institute for Clinical Trials and Methodology, London, UK.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Carpenter', 'Affiliation': 'MRC Clinical Trials Unit, University College London Institute for Clinical Trials and Methodology, London, UK.'}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'MRC Clinical Trials Unit, University College London Institute for Clinical Trials and Methodology, London, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Clements', 'Affiliation': 'MRC Clinical Trials Unit, University College London Institute for Clinical Trials and Methodology, London, UK.'}, {'ForeName': 'Mahesh Kb', 'Initials': 'MK', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Unit, University College London Institute for Clinical Trials and Methodology, London, UK.'}]","Clinical trials (London, England)",['10.1177/1740774520944377']
2200,33156414,Eccentric exercise per se does not affect muscle damage biomarkers: early and late phase adaptations.,"PURPOSE
Acute high-intensity unaccustomed eccentric exercise performed by naive subjects is accompanied by disturbances in muscle damage biomarkers. The aim of the study was to investigate whether a causal relationship indeed exists between eccentric exercise and muscle damage.
METHODS
Twenty-four men randomly assigned into a concentric only or an eccentric-only training group and performed 10 weeks of isokinetic resistance exercise (one session/week of 75 maximal knee extensors actions). Physiological markers of muscle function and damage (i.e., range of motion, delayed onset muscle soreness, isometric, concentric and eccentric peak torque) were assessed prior to and 1-3 and 5 days post each session. Biochemical markers of muscle damage (creatine kinase) and inflammation (C-reactive protein) were measured prior and 2 days post each session.
RESULTS
After the first bout, eccentric exercise induced greater muscle damage compared to concentric exercise; however, during the nine following sessions, this effect progressively diminished, while after the 10th week of training, no alterations in muscle damage biomarkers were observed after either exercise protocol. Additionally, strength gains at the end of the training period were comparable between the two groups and were mode-specific.
CONCLUSION
(1) eccentric exercise per se does not affect muscle damage biomarkers; (2) muscle damage occurs as a result of muscle unaccustomedness to this action type; (3) exercise-induced muscle damage is not a prerequisite for increased muscle strength. Collectively, we believe that muscle unaccustomedness to high-intensity eccentric exercise, and not eccentric exercise per se, is the trigger for muscle damage as indicated by muscle damage biomarkers.",2020,"Biochemical markers of muscle damage (creatine kinase) and inflammation (C-reactive protein) were measured prior and 2 days post each session.
",['Twenty-four men randomly assigned into a'],"['eccentric exercise', 'concentric only or an eccentric-only training group and performed 10\xa0weeks of isokinetic resistance exercise', 'Eccentric exercise']","['Physiological markers of muscle function and damage (i.e., range of motion, delayed onset muscle soreness, isometric, concentric and eccentric peak torque', 'muscle damage', 'strength gains', 'Biochemical markers of muscle damage (creatine kinase) and inflammation (C-reactive protein', 'muscle damage biomarkers']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",24.0,0.0255991,"Biochemical markers of muscle damage (creatine kinase) and inflammation (C-reactive protein) were measured prior and 2 days post each session.
","[{'ForeName': 'Nikos V', 'Initials': 'NV', 'LastName': 'Margaritelis', 'Affiliation': 'Dialysis Unit, 424 General Military Hospital of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Anastasios A', 'Initials': 'AA', 'LastName': 'Theodorou', 'Affiliation': 'Department of Health Sciences, School of Sciences, European University Cyprus, Nicosia, Cyprus.'}, {'ForeName': 'Panagiotis N', 'Initials': 'PN', 'LastName': 'Chatzinikolaou', 'Affiliation': 'Department of Physical Education and Sport Science at Serres, Aristotle University of Thessaloniki, Serres, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Kyparos', 'Affiliation': 'Department of Physical Education and Sport Science at Serres, Aristotle University of Thessaloniki, Serres, Greece.'}, {'ForeName': 'Michalis G', 'Initials': 'MG', 'LastName': 'Nikolaidis', 'Affiliation': 'Department of Physical Education and Sport Science at Serres, Aristotle University of Thessaloniki, Serres, Greece.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Paschalis', 'Affiliation': 'Department of Physical Education and Sport Sciences, School of Physical Education and Sport Science, National and Kapodistrian University of Athens, Ethnikis Αntistasis 41, 17237, Athens, Greece. vpaschalis@phed.uoa.gr.'}]",European journal of applied physiology,['10.1007/s00421-020-04528-w']
2201,33156447,Novel physiologic nomogram discriminates symptom outcome in patients with erosive esophagitis.,"BACKGROUND AND AIM
Most of patients with erosive esophagitis (EE) are of LA grade A&B with low reflux burden, therefore require further esophageal function tests (EFTs). One-third of them respond poorly to pump proton inhibitor (PPI) treatment. The aim was to establish and validate a physiologic nomogram to discriminate symptom outcome to PPI treatment in patients with EE.
METHODS
A total of 79 EE patients with heartburn who underwent EFTs and received PPI therapy were randomly assigned into a training set (n = 55) and a validation set (n = 24). Clinical data including physiologic parameters from EFTs were collected. Significant factors for the positive symptomatic outcome were identified using logistic regression analysis. Physiologic signature was developed using the least absolute shrinkage and selection operator algorithm. The nomogram was established by combining significant factors and physiologic signature, and its performance was evaluated and validated in the training and validation set. The clinical value of the nomogram was measured by decision curve analysis.
RESULTS
Significant factors for positive symptomatic response to PPI treatment were identified as follows: acid exposure time, total number of reflux episodes, and two novel metrics including mean nocturnal baseline impedance and post-reflux swallow-induced peristaltic wave index. The nomogram which incorporated both significant factors and physiologic signature demonstrated good performance in the training and validation sets [C-index: 0.938 (95% CI 0.882-0.995); 0.839 (95% CI 0.678-0.995), respectively]. Decision curves showed significant clinical usefulness.
CONCLUSION
The first physiologic nomogram was developed to discriminate the individualized response to PPI therapy among EE patients.",2020,"Decision curves showed significant clinical usefulness.
","['79 EE patients with heartburn who underwent EFTs and received', 'patients with erosive esophagitis (EE', 'patients with EE', 'patients with erosive esophagitis']",['PPI therapy'],"['acid exposure time, total number of reflux episodes', 'mean nocturnal baseline impedance and post-reflux swallow-induced peristaltic wave index']","[{'cui': 'C0267055', 'cui_str': 'Erosive esophagitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C1531882', 'cui_str': 'Esophageal function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",79.0,0.0233596,"Decision curves showed significant clinical usefulness.
","[{'ForeName': 'Mengyu', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-sen University, 58 Zhongshan II Road, Guangzhou, 510080, Guangdong Province, China.'}, {'ForeName': 'Mengya', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiac Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Songfeng', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-sen University, 58 Zhongshan II Road, Guangzhou, 510080, Guangdong Province, China.'}, {'ForeName': 'Niandi', 'Initials': 'N', 'LastName': 'Tan', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-sen University, 58 Zhongshan II Road, Guangzhou, 510080, Guangdong Province, China.'}, {'ForeName': 'Yuwen', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-sen University, 58 Zhongshan II Road, Guangzhou, 510080, Guangdong Province, China.'}, {'ForeName': 'Yinglian', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-sen University, 58 Zhongshan II Road, Guangzhou, 510080, Guangdong Province, China. xyingl@mail.sysu.edu.cn.'}]",Esophagus : official journal of the Japan Esophageal Society,['10.1007/s10388-020-00793-y']
2202,33156550,Exposure-Response Analyses for Upadacitinib Efficacy in Subjects with Atopic Dermatitis - Analyses of Phase 2b Study to Support Selection of Phase 3 Doses.,"Upadacitinib is a selective Janus Kinase 1 inhibitor, which was recently approved for treatment of rheumatoid arthritis (RA) and is currently being evaluated for treatment of several other autoimmune diseases, including atopic dermatitis (AD). The relationships between upadacitinib plasma exposures and efficacy (assessed as Eczema Area Severity Index (EASI)-75, EASI-90, and Investigator Global Assessment (IGA)0/1) in subjects with moderate to severe AD were characterized using the data from 167 subjects who were enrolled in a Phase 2b dose-ranging study. Subjects were randomized to receive once-daily doses of monotherapy treatment with upadacitinib extended-release 7.5 mg, 15 mg, 30 mg, or placebo for 16 weeks. Logistic regression models were developed and utilized to simulate efficacy for upadacitinib with an approximate Phase 3 sample size. Based on exposure-response models, 15 mg QD is predicted to achieve EASI-75, EASI-90, and IGA 0/1 responses in 48%, 26%, and 29% of subjects compared to placebo responses of 9%, 2%, and 2%, respectively, while 30 mg QD is predicted to approximately provide additional 20% greater efficacy for these endpoints relative to 15 mg QD. These analyses supported the selection of upadacitinib doses which are being evaluated in ongoing global Phase 3 studies in AD. This article is protected by copyright. All rights reserved.",2020,"The relationships between upadacitinib plasma exposures and efficacy (assessed as Eczema Area Severity Index (EASI)-75, EASI-90, and Investigator Global Assessment (IGA)0/1) in subjects with moderate to severe AD were characterized using the data from 167 subjects who were enrolled in a Phase 2b dose-ranging study.","['Subjects with Atopic Dermatitis', 'subjects with moderate to severe AD were characterized using the data from 167 subjects who were enrolled in a Phase 2b dose-ranging study']","['monotherapy treatment with upadacitinib extended-release 7.5 mg, 15 mg, 30 mg, or placebo']","['Eczema Area Severity Index (EASI)-75, EASI-90, and Investigator Global Assessment (IGA)0/1', 'EASI-75, EASI-90, and IGA 0/1 responses']","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}]",167.0,0.0395796,"The relationships between upadacitinib plasma exposures and efficacy (assessed as Eczema Area Severity Index (EASI)-75, EASI-90, and Investigator Global Assessment (IGA)0/1) in subjects with moderate to severe AD were characterized using the data from 167 subjects who were enrolled in a Phase 2b dose-ranging study.","[{'ForeName': 'Mohamed-Eslam F', 'Initials': 'MF', 'LastName': 'Mohamed', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Sathej', 'Initials': 'S', 'LastName': 'Gopalakrishnan', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co KG, Germany.'}, {'ForeName': 'Henrique D', 'Initials': 'HD', 'LastName': 'Teixeira', 'Affiliation': 'Immunology Development, AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc, North Chicago, IL, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1782']
2203,32400342,Challenges in Protocol Development and Interpretation of the Schistosomiasis Consortium for Operational Research and Evaluation Intervention Studies.,"In 2010, the Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) began the design of randomized controlled trials to compare different strategies for praziquantel mass drug administration, whether for gaining or sustaining control of schistosomiasis or for approaching local elimination of Schistosoma transmission. The goal of this operational research was to expand the evidence base for policy-making for regional and national control of schistosomiasis in sub-Saharan Africa. Over the 10-year period of its research programs, as SCORE operational research projects were implemented, their scope and scale posed important challenges in terms of research performance and the final interpretation of their results. The SCORE projects yielded valuable data on program-level effectiveness and strengths and weaknesses in performance, but in most of the trials, a greater-than-expected variation in community-level responses to assigned schedules of mass drug administration meant that identification of a dominant control strategy was not possible. This article critically reviews the impact of SCORE's cluster randomized study design on performance and interpretation of large-scale operational research such as ours.",2020,"In 2010, the Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) began the design of randomized controlled trials to compare different strategies for praziquantel mass drug administration, whether for gaining or sustaining control of schistosomiasis or for approaching local elimination of Schistosoma transmission.",[],[],[],[],[],[],,0.130892,"In 2010, the Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) began the design of randomized controlled trials to compare different strategies for praziquantel mass drug administration, whether for gaining or sustaining control of schistosomiasis or for approaching local elimination of Schistosoma transmission.","[{'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'King', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Nupur', 'Initials': 'N', 'LastName': 'Kittur', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Wiegand', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Whalen', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Carl H', 'Initials': 'CH', 'LastName': 'Campbell', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hattendorf', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Binder', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0805']
2204,32400354,SCORE Operational Research on Moving toward Interruption of Schistosomiasis Transmission.,"As part of its diverse portfolio, the Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) included two cluster-randomized trials evaluating interventions that could potentially lead to interruption of schistosomiasis transmission (elimination) in areas of Africa with low prevalence and intensity of infection. These studies, conducted in Zanzibar and Côte d'Ivoire, demonstrated that multiyear mass drug administration (MDA) with praziquantel failed to interrupt the transmission of urogenital schistosomiasis, even when provided biannually and/or supplemented by small-scale implementation of additional interventions. Other SCORE activities related to elimination included a feasibility and acceptability assessment of test-treat-track-test-treat (T5) strategies and mathematical modeling. Future evaluations of interventions to eliminate schistosomiasis should recognize the difficulties inherent in conducting randomized controlled trials on elimination and in measuring small changes where baseline prevalence is low. Highly sensitive and specific diagnostic tests for use in very low-prevalence areas for schistosomiasis are not routinely available, which complicates accurate measurement of infection rates and assessment of changes resulting from interventions in these settings. Although not encountered in these two studies, as prevalence and intensity decrease, political and community commitment to population-wide MDA may decrease. Because of this potential problem, SCORE developed and funded the T5 strategy implemented in Egypt, Kenya, and Tanzania. It is likely that focal MDA campaigns, along with more targeted approaches, including a T5 strategy and snail control, will need to be supplemented with the provision of clean water and sanitation and behavior change communications to achieve interruption of schistosome transmission.",2020,"Highly sensitive and specific diagnostic tests for use in very low-prevalence areas for schistosomiasis are not routinely available, which complicates accurate measurement of infection rates and assessment of changes resulting from interventions in these settings.",[],[],[],[],[],[],2.0,0.0632555,"Highly sensitive and specific diagnostic tests for use in very low-prevalence areas for schistosomiasis are not routinely available, which complicates accurate measurement of infection rates and assessment of changes resulting from interventions in these settings.","[{'ForeName': 'Carl H', 'Initials': 'CH', 'LastName': 'Campbell', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Binder', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'King', 'Affiliation': 'Center for Global Health and Diseases, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Knopp', 'Affiliation': 'Department of Life Sciences, Wolfson Wellcome Biomedical Laboratories, Natural History Museum, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rollinson', 'Affiliation': 'London Centre for Neglected Tropical Disease Research, Imperial College Faculty of Medicine, London, United Kingdom.'}, {'ForeName': 'Bobbie', 'Initials': 'B', 'LastName': 'Person', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Webster', 'Affiliation': 'London Centre for Neglected Tropical Disease Research, Imperial College Faculty of Medicine, London, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Allan', 'Affiliation': 'London Centre for Neglected Tropical Disease Research, Imperial College Faculty of Medicine, London, United Kingdom.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Utzinger', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Shaali M', 'Initials': 'SM', 'LastName': 'Ame', 'Affiliation': 'Public Health Laboratory - Ivo de Carneri, Pemba, United Republic of Tanzania.'}, {'ForeName': 'Said M', 'Initials': 'SM', 'LastName': 'Ali', 'Affiliation': 'Public Health Laboratory - Ivo de Carneri, Pemba, United Republic of Tanzania.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Kabole', 'Affiliation': 'Neglected Tropical Diseases Unit, Ministry of Health Zanzibar, Unguja, United Republic of Tanzania.'}, {'ForeName': 'Eliézer K', 'Initials': 'EK', 'LastName': ""N'Goran"", 'Affiliation': ""Unité de Formation et de Recherche Biosciences, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Tediosi', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Salari', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Mamadou', 'Initials': 'M', 'LastName': 'Ouattara', 'Affiliation': ""Unité de Formation et de Recherche Biosciences, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Nana R', 'Initials': 'NR', 'LastName': 'Diakité', 'Affiliation': ""Unité de Formation et de Recherche Biosciences, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hattendorf', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'S Andros', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Nupur', 'Initials': 'N', 'LastName': 'Kittur', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Colley', 'Affiliation': 'Department of Microbiology, University of Georgia, Athens, Georgia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0825']
2205,32400356,Impact of Different Mass Drug Administration Strategies for Gaining and Sustaining Control of Schistosoma mansoni and Schistosoma haematobium Infection in Africa.,"This report summarizes the design and outcomes of randomized controlled operational research trials performed by the Bill & Melinda Gates Foundation-funded Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) from 2009 to 2019. Their goal was to define the effectiveness and test the limitations of current WHO-recommended schistosomiasis control protocols by performing large-scale pragmatic trials to compare the impact of different schedules and coverage regimens of praziquantel mass drug administration (MDA). Although there were limitations to study designs and performance, analysis of their primary outcomes confirmed that all tested regimens of praziquantel MDA significantly reduced local Schistosoma infection prevalence and intensity among school-age children. Secondary analysis suggested that outcomes in locations receiving four annual rounds of MDA were better than those in communities that had treatment holiday years, in which no praziquantel MDA was given. Statistical significance of differences was obscured by a wider-than-expected variation in community-level responses to MDA, defining a persistent hot spot obstacle to MDA success. No MDA schedule led to elimination of infection, even in those communities that started at low prevalence of infection, and it is likely that programs aiming for elimination of transmission will need to add supplemental interventions (e.g., snail control, improvement in water, sanitation and hygiene, and behavior change interventions) to achieve that next stage of control. Recommendations for future implementation research, including exploration of the value of earlier program impact assessment combined with intensification of intervention in hot spot locations, are discussed.",2020,"No MDA schedule led to elimination of infection, even in those communities that started at low prevalence of infection, and it is likely that programs aiming for elimination of transmission will need to add supplemental interventions (e.g., snail control, improvement in water, sanitation and hygiene, and behavior change interventions) to achieve that next stage of control.",['Africa'],"['praziquantel mass drug administration (MDA', 'praziquantel MDA']",[],"[{'cui': 'C0001737', 'cui_str': 'Africa'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}]",[],,0.0552835,"No MDA schedule led to elimination of infection, even in those communities that started at low prevalence of infection, and it is likely that programs aiming for elimination of transmission will need to add supplemental interventions (e.g., snail control, improvement in water, sanitation and hygiene, and behavior change interventions) to achieve that next stage of control.","[{'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'King', 'Affiliation': 'Center for Global Health and Diseases, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Nupur', 'Initials': 'N', 'LastName': 'Kittur', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Binder', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Carl H', 'Initials': 'CH', 'LastName': 'Campbell', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Eliézer K', 'Initials': 'EK', 'LastName': ""N'Goran"", 'Affiliation': ""Centre Suisse de Recherches Scientifiques en Côte d'Ivoire, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Aboulaye', 'Initials': 'A', 'LastName': 'Meite', 'Affiliation': ""Programme National de Lutte Contre les Maladies Tropicales Négligées à Chimiothérapie Préventive (PNLMTN-CP), Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Utzinger', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Olsen', 'Affiliation': 'Section for Parasitology and Aquatic Pathobiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Magnussen', 'Affiliation': 'Centre for Medical Parasitology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Safari', 'Initials': 'S', 'LastName': ""Kinung'hi"", 'Affiliation': 'National Institute for Medical Research, Mwanza, Tanzania.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Fenwick', 'Affiliation': 'Schistosomiasis Control Initiative, Imperial College, London, United Kingdom.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Phillips', 'Affiliation': 'Schistosomiasis Control Initiative, Imperial College, London, United Kingdom.'}, {'ForeName': 'Pedro H', 'Initials': 'PH', 'LastName': 'Gazzinelli-Guimaraes', 'Affiliation': 'Schistosomiasis Control Initiative, Imperial College, London, United Kingdom.'}, {'ForeName': 'Neerav', 'Initials': 'N', 'LastName': 'Dhanani', 'Affiliation': 'Schistosomiasis Control Initiative, Imperial College, London, United Kingdom.'}, {'ForeName': 'Josefo', 'Initials': 'J', 'LastName': 'Ferro', 'Affiliation': 'Catholic University of Mozambique, Beira, Mozambique.'}, {'ForeName': 'Diana M S', 'Initials': 'DMS', 'LastName': 'Karanja', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Pauline N M', 'Initials': 'PNM', 'LastName': 'Mwinzi', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Montgomery', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Wiegand', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'William Evan', 'Initials': 'WE', 'LastName': 'Secor', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Amina A', 'Initials': 'AA', 'LastName': 'Hamidou', 'Affiliation': 'Réseau International Schistosomoses, Environnement, Aménagement et Lutte (RISEAL-Niger), Niamey, Niger.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Garba', 'Affiliation': 'Department of Control of Neglected Tropical Diseases, Preventive Chemotherapy and Transmission Control Unit, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Colley', 'Affiliation': 'Department of Microbiology, University of Georgia, Athens, Georgia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0829']
2206,31827470,Vaccine-Induced Antibodies Mediate Higher Antibody-Dependent Cellular Cytotoxicity After Interleukin-15 Pretreatment of Natural Killer Effector Cells.,"The secondary analyses for correlates of risk of infection in the RV144 HIV-1 vaccine trial implicated vaccine-induced antibody-dependent cellular cytotoxicity (ADCC) responses in the observed protection, highlighting the importance of assessing such responses in ongoing and future HIV-1 vaccine trials. However, in vitro assays that detect ADCC activity in plasma from HIV-1 infected seropositive individuals are not always effective at detecting ADCC activity in plasma from HIV-1 vaccine recipients. In vivo , ADCC-mediating antibodies must operate at the site of infection, where effector cells are recruited and activated by a local milieu of chemokines and cytokines. Based on previous findings that interleukin 15 (IL-15) secretion increases during acute HIV-1 infection and enhances NK cell-mediated cytotoxicity, we hypothesized that IL-15 pretreatment of NK effector cells could be used to improve killing of infected cells by vaccine-induced antibodies capable of mediating ADCC. Using the HIV-1 infectious molecular clone (IMC)-infected target cell assay along with plasma samples from HIV-1 vaccine recipients, we found that IL-15 treatment of effector cells improved the ability of the vaccine-induced antibodies to recruit effector cells for ADCC. Through immunophenotyping experiments, we showed that this improved killing was likely due to IL-15 mediated activation of NK effector cells and higher intracellular levels of perforin and granzyme B in the IL-15 pretreated NK cells. We also found that using a 4-fold dilution series of plasma and subtraction of pre-vaccination responses resulted in lowest response rates among placebo recipients and significant separation between treatment groups. This represents the first attempt to utilize IL-15-treated effector cells and optimized analytical approaches to improve the detection of HIV-1 vaccine-induced ADCC responses and will inform analyses of future HIV vaccine clinical trials.",2019,"Through immunophenotyping experiments, we showed that this improved killing was likely due to IL-15 mediated activation of NK effector cells and higher intracellular levels of perforin and granzyme B in the IL-15 pretreated NK cells.",[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.161107,"Through immunophenotyping experiments, we showed that this improved killing was likely due to IL-15 mediated activation of NK effector cells and higher intracellular levels of perforin and granzyme B in the IL-15 pretreated NK cells.","[{'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Fisher', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Zinter', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC, United States.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Stanfield-Oakley', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC, United States.'}, {'ForeName': 'Lindsay N', 'Initials': 'LN', 'LastName': 'Carpp', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'R Whitney', 'Initials': 'RW', 'LastName': 'Edwards', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Denny', 'Affiliation': 'Duke University Medical Center, Duke Human Vaccine Institute, Durham, NC, United States.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Moodie', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Laher', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Soweto, South Africa.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Tomaras', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC, United States.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Pollara', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC, United States.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC, United States.'}]",Frontiers in immunology,['10.3389/fimmu.2019.02741']
2207,33152522,Patient acceptable symptom state for patient-reported outcomes in people with non-specific chronic low back pain.,"BACKGROUND
The patient acceptable symptom state (PASS) is a treatment-response criterion developed to determine the clinical relevance of a treatment effect. Its estimates for some patient-reported outcomes (PROs) in non-specific chronic low back pain (cLBP) are lacking and the stability of PRO estimates between independent cLBP populations is unknown. We hypothesized that these PRO estimates will be stable.
OBJECTIVES
To estimate and compare the PASS for PROs between 2 independent cLBP populations.
METHODS
We conducted a secondary analysis of a randomized controlled trial (PREDID) and a cohort of outpatients with non-specific cLBP. Using an anchoring question, participants who self-rated their health as ""excellent"", ""very good"" or ""good"" at 1 month were considered to have an acceptable symptom state. PASS estimates for 5 PROs were calculated by using the 75 th percentile method. Estimates were compared between the 2 populations with bootstrap resampling.
RESULTS
A total of 256 participants with non-specific cLBP were included: 135 patients with cLBP and active discopathy from the PREDID trial and 121 outpatients with cLBP without active discopathy followed up in an independent cohort. Overall, 137/256 (54%) participants had an acceptable symptom state at 1 month. PASS estimates were 47.5 (95% confidence interval [CI] 40.0 to 50.0)/100 for lumbar pain (0, no pain and 100, maximal pain), 30.5 (30.0 to 40.0)/100 for radicular pain, 39.3 (33.6 to 45.3)/100 for Quebec Back Pain Disability score (0, no disability and 100, maximal disability), 10.0 (9.2 to 10.0)/21 for the Hospital Anxiety Depression anxiety subscale (0, no anxiety, and 21, maximal anxiety) and 6.7 (6.0 to 8.0)/21 for the depression subscale (0, no depression, and 21, maximal depression). PASS estimates did not differ between the 2 populations.
CONCLUSIONS
Our study provides PASS estimates for 5 PROs commonly used in cLBP. Our estimates were stable between 2 independent populations of people with cLBP. The stability of our PASS estimates suggests that they are relevant for interpreting PRO values in clinical trials and practice. ClinicalTrials.gov no. (PREDID trial) NCT00804531.",2020,"PASS estimates did not differ between the 2 populations.
","['people with non-specific chronic low back pain', 'outpatients with non-specific cLBP', '256 participants with non-specific cLBP were included: 135 patients with cLBP and active discopathy from the PREDID trial and 121 outpatients with cLBP without active discopathy followed up in an independent cohort']",[],"['acceptable symptom state', 'Hospital Anxiety Depression anxiety subscale (0, no anxiety, and 21, maximal anxiety', 'Quebec Back Pain Disability score', 'PASS estimates', 'lumbar pain (0, no pain and 100, maximal pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2747858', 'cui_str': 'Discopathy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",256.0,0.166062,"PASS estimates did not differ between the 2 populations.
","[{'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Daste', 'Affiliation': ""Université de Paris, Faculté de Santé, UFR de Médecine de Paris Centre, 75006 Paris, France; AP-HP.Centre-Université de Paris, Hôpital Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, 75014 Paris, France; INSERM UMR-S 1153, Centre de Recherche Épidémiologie et Statistique Paris (CRESS), ECaMO Team, 75004 Paris, France.""}, {'ForeName': 'Hendy', 'Initials': 'H', 'LastName': 'Abdoul', 'Affiliation': ""Unité de Recherche Clinique-Centre d'Investigation Clinique Paris Descartes Necker/Cochin, Hôpital Tarnier, 75006 Paris, France.""}, {'ForeName': 'Frantz', 'Initials': 'F', 'LastName': 'Foissac', 'Affiliation': ""Unité de Recherche Clinique-Centre d'Investigation Clinique Paris Descartes Necker/Cochin, Hôpital Tarnier, 75006 Paris, France; EA 7323, Évaluation des thérapeutiques et pharmacologie périnatale et pédiatrique, 75006 Paris, France.""}, {'ForeName': 'Marie-Martine', 'Initials': 'MM', 'LastName': 'Lefèvre-Colau', 'Affiliation': ""Université de Paris, Faculté de Santé, UFR de Médecine de Paris Centre, 75006 Paris, France; AP-HP.Centre-Université de Paris, Hôpital Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, 75014 Paris, France; INSERM UMR-S 1153, Centre de Recherche Épidémiologie et Statistique Paris (CRESS), ECaMO Team, 75004 Paris, France; Institut Fédératif de Recherche sur le Handicap, 75013 Paris, France.""}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Poiraudeau', 'Affiliation': ""Université de Paris, Faculté de Santé, UFR de Médecine de Paris Centre, 75006 Paris, France; AP-HP.Centre-Université de Paris, Hôpital Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, 75014 Paris, France; INSERM UMR-S 1153, Centre de Recherche Épidémiologie et Statistique Paris (CRESS), ECaMO Team, 75004 Paris, France; Institut Fédératif de Recherche sur le Handicap, 75013 Paris, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Rannou', 'Affiliation': ""Université de Paris, Faculté de Santé, UFR de Médecine de Paris Centre, 75006 Paris, France; AP-HP.Centre-Université de Paris, Hôpital Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, 75014 Paris, France; INSERM UMR-S 1124, Toxicité Environnementale, Cibles Thérapeutiques, Signalisation Cellulaire et Biomarqueurs (T3S), Campus Saint-Germain-des-Prés, 75006 Paris, France.""}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': ""Université de Paris, Faculté de Santé, UFR de Médecine de Paris Centre, 75006 Paris, France; AP-HP.Centre-Université de Paris, Hôpital Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, 75014 Paris, France; INSERM UMR-S 1124, Toxicité Environnementale, Cibles Thérapeutiques, Signalisation Cellulaire et Biomarqueurs (T3S), Campus Saint-Germain-des-Prés, 75006 Paris, France. Electronic address: christelle.nguyen2@aphp.fr.""}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.10.005']
2208,33152542,"A Phase 2 Double Blinded, Randomized Controlled Trial of Saroglitazar in Patients with Nonalcoholic Steatohepatitis.",,2020,,['Patients with Nonalcoholic Steatohepatitis'],['Saroglitazar'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]",[],[],,0.761948,,"[{'ForeName': 'Mohammad Shadab', 'Initials': 'MS', 'LastName': 'Siddiqui', 'Affiliation': 'Division of Gastroenterology and Hepatology Virginia Commonwealth University (VCU). Electronic address: Mohammad.siddiqui@vcuhealth.org.'}, {'ForeName': 'Michael O', 'Initials': 'MO', 'LastName': 'Idowu', 'Affiliation': 'Department of Pathology, VCU, Richmond, VA.'}, {'ForeName': 'Deven', 'Initials': 'D', 'LastName': 'Parmar', 'Affiliation': 'Zydus Discovery DMCC, Dubai UAE.'}, {'ForeName': 'Brian B', 'Initials': 'BB', 'LastName': 'Borg', 'Affiliation': 'Southern Therapy and Advanced Research (STAR) LLC, Jackson, MS.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Denham', 'Affiliation': 'Clinical Trials of Texas, Inc. San Antonio, TX.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Loo', 'Affiliation': 'American Research Corporation, The Texas Liver Institute, San Antonio, TX.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Lazas', 'Affiliation': 'Digestive Health Research, / Objective GI Nashville, TN.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Younes', 'Affiliation': 'Gastro One, Clinical Research Department, Germantown, TN.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Division of Gastroenterology and Hepatology Virginia Commonwealth University (VCU).'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.10.051']
2209,33152575,"Letter to the Editor regarding ""Dexamethasone eardrop with grommet placement vs intratympanic steroid injection for sudden sensorineural hearing loss: A randomized prospective clinical trial"".",,2020,,['sudden sensorineural hearing loss'],['Dexamethasone eardrop with grommet placement vs intratympanic steroid injection'],[],"[{'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}]",[],,0.0413105,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, New Delhi, India. Electronic address: anoop.aiims1@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sagar', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, New Delhi, India.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102785']
2210,33152609,Effects of a 10-week running-retraining programme on the foot strike pattern of adolescents: A longitudinal intervention study.,"BACKGROUND
The purpose of this study was to analyse the effects of ten weeks of different running-retraining programmes on rearfoot strike (RFS) prevalence in adolescents.
RESEARCH QUESTION
it is possible to change foot strike pattern in adolescents?
METHODS
A total of 180 children (45.3% girls), aged 13-16 years, participated in this intervention study. The children were randomly assigned to one of three experimental groups (EGs) that each carried out a different retraining programme, based on running technique (n = 39), a 15% increased step frequency (SF) (n = 37) and barefoot training (n = 30), performed for three days each week. A control group (CG) (n = 43) did not perform any retraining. A 2D video-based analysis (240 Hz) was used to determine the RFS.
RESULTS
At baseline, no significant differences in RFS prevalence were found between the EGs and the CG in either the left (χ 2 = 2.048; p = 0.559) or the right foot (χ 2 = 0.898; p = 0.825). In the post-test, no significant differences were found for the left foot (χ 2 = 7.102; p = 0.069), but there were significant differences for the right foot (χ 2 = 9.239; p = 0.025) were observed. In the re-test, no significant differences were found for either the left foot (χ 2 = 2.665; p = 0.273) or the right foot (χ 2 = 2.182; p = 0.325). In addition, no group displayed significant changes in RFS prevalence from the pre-test to the re-test. There was a trend towards a reduction in the RFS prevalence in both the increased SF group and the barefoot group.
MEANING
The main finding of this study was that certain running-retraining programmes performed three times per week for ten weeks are not enough to modify the adolescent foot strike pattern (FSP).",2020,"There was a trend towards a reduction in the RFS prevalence in both the increased SF group and the barefoot group.
","['adolescents', '180 children (45.3% girls), aged 13-16 years']","['running-retraining programmes', '10-week running-retraining programme', 'barefoot training']","['RFS prevalence', 'rearfoot strike (RFS) prevalence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0277844', 'cui_str': 'Barefoot walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",180.0,0.0205722,"There was a trend towards a reduction in the RFS prevalence in both the increased SF group and the barefoot group.
","[{'ForeName': 'Pedro José', 'Initials': 'PJ', 'LastName': 'Consuegra González', 'Affiliation': 'University of Jaen, Spain. C/Sacramento, 7 Úbeda (Jaén), España. Electronic address: consuegragonzalezpj@gmail.com.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'García-Pinillos', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, Spain; Department of Physical Education, Sports and Recreation. Universidad de La Frontera, Temuco, Chile. Electronic address: fegarpi@gmail.com.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Mora López', 'Affiliation': 'I.E.S. Cañada de las Fuentes, Spain.'}, {'ForeName': 'Antonio José', 'Initials': 'AJ', 'LastName': 'Cardona Linares', 'Affiliation': 'University Pablo De Olavide of Seville, Spain. Electronic address: ajcarlin@upo.es.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Párraga Montilla', 'Affiliation': 'University of Jaen, Spain. Electronic address: jparraga@ujaen.es.'}, {'ForeName': 'Pedro Ángel', 'Initials': 'PÁ', 'LastName': 'Latorre-Román', 'Affiliation': 'University of Jaen, Spain. Electronic address: platorre@ujaen.es.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.024']
2211,33152672,"Health economic design for cost, cost-effectiveness and simulation analyses in the HEALing Communities Study.","BACKGROUND
The HEALing Communities Study (HCS) is designed to implement and evaluate the Communities That HEAL (CTH) intervention, a conceptually driven framework to assist communities in selecting and adopting evidence-based practices to reduce opioid overdose deaths. The goal of the HCS is to produce generalizable information for policy makers and community stakeholders seeking to implement CTH or a similar community intervention. To support this objective, one aim of the HCS is a health economics study (HES), the results of which will inform decisions around fiscal feasibility and sustainability relevant to other community settings.
METHODS
The HES is integrated into the HCS design: an unblinded, multisite, parallel arm, cluster randomized, wait list-controlled trial of the CTH intervention implemented in 67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio. The objectives of the HES are to estimate the economic costs to communities of implementing and sustaining CTH; estimate broader societal costs associated with CTH; estimate the cost-effectiveness of CTH for overdose deaths avoided; and use simulation modeling to evaluate the short- and long-term health and economic impact of CTH, including future overdose deaths avoided and quality-adjusted life years saved, and to develop a simulation policy tool for communities that seek to implement CTH or a similar community intervention.
DISCUSSION
The HCS offers an unprecedented opportunity to conduct health economics research on solutions to the opioid crisis and to increase understanding of the impact and value of complex, community-level interventions.",2020,"The HES is integrated into the HCS design: an unblinded, multisite, parallel arm, cluster randomized, wait list-controlled trial of the CTH intervention implemented in 67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio.","['67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio']","['CTH intervention', 'HCS', 'HEAL (CTH) intervention', 'CTH']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],,0.0271047,"The HES is integrated into the HCS design: an unblinded, multisite, parallel arm, cluster randomized, wait list-controlled trial of the CTH intervention implemented in 67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio.","[{'ForeName': 'Arnie P', 'Initials': 'AP', 'LastName': 'Aldridge', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, RTP, NC, 27709, United States. Electronic address: aaldridge@rti.org.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Barbosa', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, RTP, NC, 27709, United States.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Barocas', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA, 02118, United States; University of Pennsylvania School of Nursing, 418 Curie Blvd, Philadelphia, PA, 19104, United States.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Bush', 'Affiliation': 'University of Kentucky, College of Public Health, 111 Washington Ave., Lexington, KY, 40536, United States.'}, {'ForeName': 'Jagpreet', 'Initials': 'J', 'LastName': 'Chhatwal', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, 55 Fruit St, Boston, MA, 02114, United States.'}, {'ForeName': 'Kristin J', 'Initials': 'KJ', 'LastName': 'Harlow', 'Affiliation': 'The Ohio State University College of Public Health, 250 Cunz Hall, 1841 Neil Ave., Columbus, OH, 43210, United States.'}, {'ForeName': 'Ayaz', 'Initials': 'A', 'LastName': 'Hyder', 'Affiliation': 'The Ohio State University College of Public Health, 250 Cunz Hall, 1841 Neil Ave., Columbus, OH, 43210, United States.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Linas', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA, 02118, United States.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'McCollister', 'Affiliation': 'University of Miami Miller School of Medicine, 1120 NW 14(th)Street, Suite 1019, Miami, FL, 33136, United States.'}, {'ForeName': 'Jake R', 'Initials': 'JR', 'LastName': 'Morgan', 'Affiliation': 'Boston University School of Public Health, 715 Albany St, Boston, MA, 02118, United States.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Weill Cornell Medicine, 425 East 61(st)Street, Suite 301, New York, NY, 10065, United States.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Savitzky', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA, 02118, United States.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Weill Cornell Medicine, 425 East 61(st)Street, Suite 301, New York, NY, 10065, United States.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Seiber', 'Affiliation': 'The Ohio State University College of Public Health, 250 Cunz Hall, 1841 Neil Ave., Columbus, OH, 43210, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'E Starbird', 'Affiliation': 'Columbia University, New York, NY, 10027, United States; University of Pennsylvania School of Nursing, 418 Curie Blvd, Philadelphia, PA, 19104, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Villani', 'Affiliation': 'National Institute on Drug Abuse, 3WFN RM08A45, MSC 6025, 301 North Stonestreet Ave, Rockville, MD, 20852, United States.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Zarkin', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, RTP, NC, 27709, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108336']
2212,33152686,Sleep Hygiene and Light Exposure Can Improve Performance Following Long-Haul Air Travel.,"PURPOSE
To assess the efficacy of a combined light exposure and sleep hygiene intervention to improve team-sport performance following eastward long-haul transmeridian travel.
METHODS
Twenty physically trained males underwent testing at 09:00 and 17:00 hours local time on 4 consecutive days at home (baseline) and the first 4 days following 21 hours of air travel east across 8 time zones. In a randomized, matched-pairs design, participants traveled with (INT; n = 10) or without (CON; n = 10) a light exposure and sleep hygiene intervention. Performance was assessed via countermovement jump, 20-m sprint, T test, and Yo-Yo Intermittent Recovery Level 1 tests, together with perceptual measures of jet lag, fatigue, mood, and motivation. Sleep was measured using wrist activity monitors in conjunction with self-report diaries.
RESULTS
Magnitude-based inference and standardized effect-size analysis indicated there was a very likely improvement in the mean change in countermovement jump peak power (effect size 1.10, ±0.55), and likely improvement in 5-m (0.54, ±0.67) and 20-m (0.74, ±0.71) sprint time in INT compared with CON across the 4 days posttravel. Sleep duration was most likely greater in INT both during travel (1.61, ±0.82) and across the 4 nights following travel (1.28, ±0.58) compared with CON. Finally, perceived mood and motivation were likely worse (0.73, ±0.88 and 0.63, ±0.87) across the 4 days posttravel in CON compared with INT.
CONCLUSIONS
Combined light exposure and sleep hygiene improved speed and power but not intermittent-sprint performance up to 96 hours following long-haul transmeridian travel. The reduction of sleep disruption during and following travel is a likely contributor to improved performance.",2020,"Sleep duration was most likely greater in INT both during travel (1.61, ±0.82) and across the 4 nights following travel (1.28, ±0.58) compared with CON.",['Twenty physically trained males underwent testing at 09:00 and 17:00 hours local time on 4 consecutive days at home (baseline) and the first 4 days following 21 hours of air travel east across 8 time zones'],"['combined light exposure and sleep hygiene intervention', 'light exposure and sleep hygiene intervention']","['Sleep', 'Performance was assessed via countermovement jump, 20-m sprint, T test, and Yo-Yo Intermittent Recovery Level 1 tests, together with perceptual measures of jet lag, fatigue, mood, and motivation', 'mean change in countermovement jump peak power', 'reduction of sleep disruption', 'perceived mood and motivation', 'Sleep duration', 'sprint time in INT']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3489667', 'cui_str': 'Travel by Air'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231311', 'cui_str': 'Jet lag'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",20.0,0.125396,"Sleep duration was most likely greater in INT both during travel (1.61, ±0.82) and across the 4 nights following travel (1.28, ±0.58) compared with CON.","[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Fowler', 'Affiliation': ''}, {'ForeName': 'Wade', 'Initials': 'W', 'LastName': 'Knez', 'Affiliation': ''}, {'ForeName': 'Heidi R', 'Initials': 'HR', 'LastName': 'Thornton', 'Affiliation': ''}, {'ForeName': 'Charli', 'Initials': 'C', 'LastName': 'Sargent', 'Affiliation': ''}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mendham', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Crowcroft', 'Affiliation': ''}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Shona', 'Initials': 'S', 'LastName': 'Halson', 'Affiliation': ''}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Duffield', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0931']
2213,33153310,"Efficacy of 0.1% crosslinked hyaluronic acid, coenzyme Q10 and vitamin E in the management of dry eye disease in menopause patients receiving antidepressants.","PURPOSE
The purpose of this study is to test non-inferiority of a lower dose of crosslinked hyaluronic acid (CLHA) to a higher dose of carmellose eye drop in menopause patients receiving antidepressant treatments.
METHODS
This prospective, double-blind, single-center study enrolled sixty female patients. Mean age was 63.25 ± 9.13 years. We examined patients with Schirmer I, breakup time (TBUT) and the ocular surface disease index (OSDI) at the first visit. Tear A eyedrops were formulated with crosslinked hyaluronic acid, coenzyme Q10 and vitamin E. Control tear B was formulated with carmellose sodium. Posology was two and five times, respectively.
RESULTS
After 2 months of treatment, the tear A obtained 14.12 ± 7.47 score points for OSDI ( t = 11.74, p < 0.01), and tear B obtained 19.46 ± 10.03 score points ( t = 7.59, p < 0.01). The tear A obtained 13.77 ± 7.78 score points for Schirmer test ( t = 0.88, p > 0.05), and tear B obtained 14.20 ± 8.62 score points ( t = 2.92, p < 0.01). The tear A obtained 8.30 ± 2.08 s for TBUT ( t = 15.50, p < 0.01), and tear B obtained 7.23 ± 2.40 s ( t = 8.79, p < 0.01).
CONCLUSION
Lower total daily dose of crosslinked hyaluronic acid eyedrops obtained similar efficacy results in terms of tear stability and subjective dry eye sensation than higher carmellose total daily dose. A lower total daily dose of crosslinked eyedrops was sufficient to achieve better dry eye disease management compared to carmellose.",2020,Lower total daily dose of crosslinked hyaluronic acid eyedrops obtained similar efficacy results in terms of tear stability and subjective dry eye sensation than higher carmellose total daily dose.,"['patients with Schirmer I, breakup time (TBUT) and the ocular surface disease index (OSDI) at the first visit', 'menopause patients receiving antidepressants', 'Mean age was 63.25\u2009±\u20099.13\u2009years', 'enrolled sixty female patients', 'menopause patients receiving antidepressant treatments']","['crosslinked eyedrops', 'crosslinked hyaluronic acid eyedrops', '0.1% crosslinked hyaluronic acid, coenzyme Q10 and vitamin E', 'crosslinked hyaluronic acid, coenzyme Q10 and vitamin E. Control tear B was formulated with carmellose sodium', 'crosslinked hyaluronic acid (CLHA']",['tear stability and subjective dry eye sensation'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0037487', 'cui_str': 'Carboxymethylcellulose sodium'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0858620', 'cui_str': 'Dry eye sensation'}]",60.0,0.0515476,Lower total daily dose of crosslinked hyaluronic acid eyedrops obtained similar efficacy results in terms of tear stability and subjective dry eye sensation than higher carmellose total daily dose.,"[{'ForeName': 'José-Manuel', 'Initials': 'JM', 'LastName': 'Serrano-Morales', 'Affiliation': 'Department of Physics of Condensed Matter, Optics Area, University of Seville, Seville, Andalucia, Spain.'}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'De-Hita-Cantalejo', 'Affiliation': 'Department of Physics of Condensed Matter, Optics Area, University of Seville, Seville, Andalucia, Spain.'}, {'ForeName': 'María Carmen', 'Initials': 'MC', 'LastName': 'Sánchez-González', 'Affiliation': 'Department of Physics of Condensed Matter, Optics Area, University of Seville, Seville, Andalucia, Spain.'}, {'ForeName': 'María-José', 'Initials': 'MJ', 'LastName': 'Bautista-Llamas', 'Affiliation': 'Department of Physics of Condensed Matter, Optics Area, University of Seville, Seville, Andalucia, Spain.'}, {'ForeName': 'José-María', 'Initials': 'JM', 'LastName': 'Sánchez-González', 'Affiliation': 'Department of Physics of Condensed Matter, Optics Area, University of Seville, Seville, Andalucia, Spain.'}]",European journal of ophthalmology,['10.1177/1120672120972026']
2214,33153313,Age Is Not a Barrier: Older Adults With Cancer Derive Similar Benefit in a Randomized Controlled Trial of a Remote Symptom Monitoring Intervention Compared With Younger Adults.,"This study investigated a remote symptom monitoring intervention to examine if older participants with cancer received a similar magnitude of benefit compared with younger adults with cancer. We analyzed a longitudinal symptom monitoring intervention for 358 participants beginning a new course of chemotherapy treatment in community and academic oncology practices. The study design was a randomized control trial; participants were randomized to the intervention or usual care, the intervention was delivered during daily automated coaching. Older adults with moderate and severe symptoms derived similar benefit as those adults younger than 60 years of age, adherence to the study protocol which involved daily calls was high. There was no significant difference between the 2 age categories; on average, older adult participants made 88% of expected daily calls and younger adult participants made 90% of expected daily calls. Our results challenge the perception that older adults are unwilling or unable to use a technological tool such as interactive voice response and suggest that patient utilization may be guided by other factors, such as ease of use and perceived benefit from the intervention.",2020,"There was no significant difference between the 2 age categories; on average, older adult participants made 88% of expected daily calls and younger adult participants made 90% of expected daily calls.","['older adults', 'older participants with cancer', 'Older adults with moderate and severe symptoms', '358 participants beginning a new course of chemotherapy treatment in community and academic oncology practices', 'younger adults with cancer']","['intervention or usual care, the intervention was delivered during daily automated coaching', 'Remote Symptom Monitoring Intervention', 'remote symptom monitoring intervention']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",[],358.0,0.0886538,"There was no significant difference between the 2 age categories; on average, older adult participants made 88% of expected daily calls and younger adult participants made 90% of expected daily calls.","[{'ForeName': 'Lorinda A', 'Initials': 'LA', 'LastName': 'Coombs', 'Affiliation': 'School of Nursing, University of North Carolina at Chapel Hill, NC USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Ellington', 'Affiliation': 'University of Utah College of Nursing, Salt Lake City, UT, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Fagerlin', 'Affiliation': 'Department of Population Health Sciences, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Kathi', 'Initials': 'K', 'LastName': 'Mooney', 'Affiliation': 'University of Utah College of Nursing, Salt Lake City, UT, USA.'}]",Cancer control : journal of the Moffitt Cancer Center,['10.1177/1073274820968878']
2215,33153350,Comparative analysis of the autonomic nervous system response during movement representation in healthy individuals and patients with chronic low back pain: a prospective cohort study.,"OBJECTIVE
The primary objective was to compare the difference in autonomic nervous system (ANS) response between motor imagery (MI) group and action observation (AO) group. Both consisted of two subgroups: the control subgroup (CG), which consisted of asymptomatic individuals, and the patient subgroup (PG), which consisted of patients with chronic low back pain (CLBP). The secondary objective was to assess ANS activity during AO and MI training according to the fear-of-movement levels of the PGs.
METHODS
Sixty participants were randomly assigned. The autonomic outcome measures included skin conductance (SC), respiration rate (RR), and heart rate (HR).
RESULTS
Results showed that intergroup differences in RR were higher in the PG, with a large effect size ( p = .007, d = 1.71). Only the PGs showed intragroup differences in SC ( p <.05). In terms of ANS activity during the training, there were no statistically significant intergroup differences ( p <.05). However, the strongest intragroup differences were among the AO PG with greater levels of kinesiophobia. For the SC and HR variables, only this condition showed significant differences between baseline and the first and second movements, with a large effect size ( p <.001 and p = .002, respectively, and d >.80).
CONCLUSIONS
The results showed that AO and MI training in the PG and CG resulted in similar but not identical ANS activation, with slightly higher activation in the PG. The differences in the PG could be associated with kinesiophobia when visually exposed to low-back movements that could be interpreted as hazardous or unsafe.",2020,"In terms of ANS activity during the training, there were no statistically significant intergroup differences ( p <.05).","['patients with chronic low back pain (CLBP', 'Sixty participants were randomly assigned', 'healthy individuals and patients with chronic low back pain']",['motor imagery (MI) group and action observation (AO'],"['skin conductance (SC), respiration rate (RR), and heart rate (HR', 'RR', 'autonomic nervous system (ANS) response', 'ANS activity during AO and MI training according to the fear-of-movement levels of the PGs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031619', 'cui_str': 'Glycerol Phosphoglycerides'}]",60.0,0.0779688,"In terms of ANS activity during the training, there were no statistically significant intergroup differences ( p <.05).","[{'ForeName': 'Marta Carlota', 'Initials': 'MC', 'LastName': 'Díaz-Sáez', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'La Touche', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cuenca-Martínez', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}]",Somatosensory & motor research,['10.1080/08990220.2020.1845137']
2216,33153401,Efficacy and safety of apixaban in patients with active malignancy and acute deep venous thrombosis.,"OBJECTIVES
Low-molecular weight heparin (LMWH) has been approved for treatment of deep venous thrombosis and venous thromboembolism which are associated with cancer. The efficacy and safety of apixaban in management of acute deep venous thrombosis associated with active malignancy is still an unresolved issue. The aim of our study is to evaluate the efficacy and safety of apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous LMWH.
METHODS
Of 138 randomized patients, 100 patients with active malignancy presenting with acute deep venous thrombosis and still treated with chemotherapy were assigned to either oral apixaban therapy or subcutaneous low-molecular weight heparin (enoxaparin) through randomized clinical study in 1:1 ratio. All patients were followed up to six months. The primary end point was major bleeding, while secondary end points were recurrent deep venous thrombosis or venous thromboembolism, minor or non-fatal bleeding and mortality related to massive pulmonary embolism.
RESULTS
Both groups were matched regarding their baseline demographic, clinical and laboratory characteristics. We had 84 patients with metastatic cancer (stage 4). The most prevalent type of malignancy was cancer colon (42% of cases). There was no significant difference between both groups regarding the incidence of primary and secondary end points. There were no reported mortality cases related to massive pulmonary embolism in both groups.
CONCLUSION
In this limited study, there was no difference in the major bleeding, recurrent deep venous thrombosis or minor bleeding in patients with active malignancy when treated with either apixaban or LMWH. Trial registration: ClinicalTrials.gov (NCT04462003). Registered 7 July 2020 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04462003.",2020,"The primary end point was major bleeding, while secondary end points were recurrent deep venous thrombosis or venous thromboembolism, minor or non-fatal bleeding and mortality related to massive pulmonary embolism.
","['patients with active malignancy and acute deep venous thrombosis', '84 patients with metastatic cancer (stage 4', 'Of 138 randomized patients, 100 patients with active malignancy presenting with acute deep venous thrombosis and still treated with', 'patients with active malignancy', 'patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous LMWH']","['apixaban or LMWH', 'oral apixaban therapy or subcutaneous low-molecular weight heparin (enoxaparin', 'heparin (LMWH', 'apixaban', 'chemotherapy']","['recurrent deep venous thrombosis or venous thromboembolism, minor or non-fatal bleeding and mortality related to massive pulmonary embolism', 'efficacy and safety', 'major bleeding', 'Efficacy and safety', 'major bleeding, recurrent deep venous thrombosis or minor bleeding', 'massive pulmonary embolism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C3536663', 'cui_str': 'Acute deep venous thrombosis'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",84.0,0.133462,"The primary end point was major bleeding, while secondary end points were recurrent deep venous thrombosis or venous thromboembolism, minor or non-fatal bleeding and mortality related to massive pulmonary embolism.
","[{'ForeName': 'Mostafa El', 'Initials': 'ME', 'LastName': 'Mokadem', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'Clinical Oncology Department, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Abdulaziz Z', 'Initials': 'AZ', 'LastName': 'Algaby', 'Affiliation': 'Vascular Surgery Department, Faculty of medicine, Beni-Suef University, Beni-Suef, Egypt.'}]",Vascular,['10.1177/1708538120971148']
2217,33153484,Effects of strategies to improve general practitioner-nurse collaboration and communication in regard to hospital admissions of nursing home residents (interprof ACT): study protocol for a cluster randomised controlled trial.,"BACKGROUND
In Germany, up to 50% of nursing home residents are admitted to a hospital at least once a year. It is often unclear whether this is beneficial or even harmful. Successful interprofessional collaboration and communication involving general practitioners (GPs) and nurses may improve medical care of nursing home residents. In the previous interprof study, the six-component intervention package interprof ACT was developed to facilitate collaboration of GPs and nurses in nursing homes. The aim of this study is to evaluate the effectiveness of the interprof ACT intervention.
METHODS
This multicentre, cluster randomised controlled trial compares nursing homes receiving the interprof ACT intervention package for a duration of 12 months (e.g. comprising appointment of mutual contact persons, shared goal setting, standardised GPs' home visits) with a control group (care as usual). A total of 34 nursing homes are randomised, and overall 680 residents recruited. The intervention package is presented in a kick-off meeting to GPs, nurses, residents/relatives or their representatives. Nursing home nurses act as change agents to support local adaption and implementation of the intervention measures. Primary outcome is the cumulative incidence of hospitalisation within 12 months. Secondary outcomes include admissions to hospital, days admitted to hospital, use of other medical services, prevalence of potentially inappropriate medication and quality of life. Additionally, health economic and a mixed methods process evaluation will be performed.
DISCUSSION
This study investigates a complex intervention tailored to local needs of nursing homes. Outcomes reflect the healthcare and health of nursing home residents, as well as the feasibility of the intervention package and its impact on interprofessional communication and collaboration. Because of its systematic development and its flexible nature, interprof ACT is expected to be viable for large-scale implementation in routine care services regardless of local organisational conditions and resources available for medical care for nursing home residents on a regular basis. Recommendations will be made for an improved organisation of primary care for nursing home residents. In addition, the results may provide important knowledge and data for the development and evaluation of further strategies to improve outpatient care for elderly care-receivers.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03426475 . Initially registered on 7 February 2018.",2020,Successful interprofessional collaboration and communication involving general practitioners (GPs) and nurses may improve medical care of nursing home residents.,"['nursing homes', '34 nursing homes are randomised, and overall 680 residents recruited', 'nursing home residents', ""nursing homes receiving the interprof ACT intervention package for a duration of 12\u2009months (e.g. comprising appointment of mutual contact persons, shared goal setting, standardised GPs' home visits) with a control group (care as usual""]","['complex intervention', 'interprof ACT intervention']","['cumulative incidence of hospitalisation', 'admissions to hospital, days admitted to hospital, use of other medical services, prevalence of potentially inappropriate medication and quality of life']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0337611', 'cui_str': 'Contact person'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0777726,Successful interprofessional collaboration and communication involving general practitioners (GPs) and nurses may improve medical care of nursing home residents.,"[{'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Müller', 'Affiliation': 'Department of General Practice, University Medical Center Göttingen, Humboldtallee 38, D-37073, Göttingen, Germany. christiane.mueller@med.uni-goettingen.de.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Hesjedal-Streller', 'Affiliation': 'Department of General Practice, University Medical Center Göttingen, Humboldtallee 38, D-37073, Göttingen, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Fleischmann', 'Affiliation': 'Nursing Science, Fulda University of Applied Sciences, Building 31, Room 122, Leipziger Straße 123, D-36037, Fulda, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Tetzlaff', 'Affiliation': 'Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Martinistraße 52, D-20246, Hamburg, Germany.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Mallon', 'Affiliation': 'Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Martinistraße 52, D-20246, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Scherer', 'Affiliation': 'Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Martinistraße 52, D-20246, Hamburg, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Köpke', 'Affiliation': 'Institute of Nursing Science, University Clinic Cologne, Gleueler Straße 176-178, D-50935, Köln, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Balzer', 'Affiliation': 'Institute for Social Medicine and Epidemiology, Nursing Research Group, University of Lübeck, Ratzeburger Allee 160, Haus 50, D-23538, Lübeck, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Gärtner', 'Affiliation': 'Institute for Social Medicine and Epidemiology, Nursing Research Group, University of Lübeck, Ratzeburger Allee 160, Haus 50, D-23538, Lübeck, Germany.'}, {'ForeName': 'Indre', 'Initials': 'I', 'LastName': 'Maurer', 'Affiliation': 'Chair of Organization and Corporate Development, Georg-August-University Göttingen, Platz der Göttinger Sieben 3, D-37073, Göttingen, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Humboldtallee 32, D-37073, Göttingen, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Martinistraße 52, D-20246, Hamburg, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hummers', 'Affiliation': 'Department of General Practice, University Medical Center Göttingen, Humboldtallee 38, D-37073, Göttingen, Germany.'}]",Trials,['10.1186/s13063-020-04736-x']
2218,33153515,Emotional intelligence intervention in older adults to improve adaptation and reduce negative mood.,"OBJECTIVES
Emotional intelligence (EI) is a strong predictor of negative mood. Applying emotional skills correctly can help to increase positive emotional states and reduce negative ones. This study aims to implement EI intervention designed to improve clarity, repair EI dimensions and coping strategies, and reduce negative mood in older adults.
DESIGN
Participants were randomly assigned to the treatment or control group.
SETTING
Participants were evaluated individually before and after the intervention.
PARTICIPANTS
Participants included 111 healthy older adults; 51 in the treatment group and 60 in the control group.
INTERVENTION
An EI program was implemented. The program was administered over 10 sessions lasting 90 min each.
MEASUREMENTS
EI dimension (attention, clarity, and repair), coping strategies, hopelessness, and mood were assessed.
RESULTS
Analysis of variance for repeated measures was applied. In the treatment group, scores on clarity and emotional repair increased and attention to emotions decreased; problem-focused coping (problem-solving, positive reappraisal, and seeking social support) showed significant increases, whereas emotion-focused coping (negative self-focused and overt emotional expression) obtained significant decreases; scores on negative mood measures declined significantly.
CONCLUSIONS
An intervention based on EI is effective in older adults. After the EI intervention, the participants showed significant increases in their levels of clarity and emotional repair and intermediate levels of attention. In addition, the intervention was found to influence adaptation results, increasing the use of adaptive coping strategies and decreasing the use of maladaptive strategies, as well as reducing hopelessness and depressive symptoms.",2020,"After the EI intervention, the participants showed significant increases in their levels of clarity and emotional repair and intermediate levels of attention.","['older adults', 'Participants were evaluated individually before and after the intervention', 'Participants included 111 healthy older adults; 51 in the treatment group and 60 in the control group']",['Emotional intelligence intervention'],"['positive emotional states', 'negative mood measures', 'scores on clarity and emotional repair increased and attention to emotions decreased; problem-focused coping (problem-solving, positive reappraisal, and seeking social support', 'hopelessness and depressive symptoms', 'emotion-focused coping (negative self-focused and overt emotional expression', 'EI dimension (attention, clarity, and repair), coping strategies, hopelessness, and mood', 'levels of clarity and emotional repair and intermediate levels of attention']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1510539', 'cui_str': 'Emotional Intelligence'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1510539', 'cui_str': 'Emotional Intelligence'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]",111.0,0.0186019,"After the EI intervention, the participants showed significant increases in their levels of clarity and emotional repair and intermediate levels of attention.","[{'ForeName': 'Iraida', 'Initials': 'I', 'LastName': 'Delhom', 'Affiliation': 'Universidad Internacional de Valencia (Spain), Pintor Sorolla, 21, Valencia, 46002, Spain.'}, {'ForeName': 'Encarnación', 'Initials': 'E', 'LastName': 'Satorres', 'Affiliation': 'Department of Developmental Psychology, Faculty of Psychology, University of Valencia (Spain), Av. Blasco Ibañez 21, Valencia, ES 46010, Spain.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Meléndez', 'Affiliation': 'Department of Developmental Psychology, Faculty of Psychology, University of Valencia (Spain), Av. Blasco Ibañez 21, Valencia, ES 46010, Spain.'}]",International psychogeriatrics,['10.1017/S1041610220003579']
2219,33153517,"Effects of primary care C-reactive protein point-of-care testing on antibiotic prescribing by general practice staff: pragmatic randomised controlled trial, England, 2016 and 2017.","BackgroundC-reactive protein (CRP) testing can be used as a point-of-care test (POCT) to guide antibiotic use for acute cough.AimWe wanted to determine feasibility and effect of introducing CRP POCT in general practices in an area with high antibiotic prescribing for patients with acute cough and to evaluate patients' views of the test.MethodsWe used a McNulty-Zelen cluster pragmatic randomised controlled trial design in general practices in Northern England. Eight intervention practices accepted CRP testing and eight control practices maintained usual practice. Data collection included process evaluation, patient questionnaires, practice audit and antibiotic prescribing data.ResultsEight practices with over 47,000 patient population undertook 268 CRP tests over 6 months: 78% of patients had a CRP < 20 mg/L, 20% CRP 20-100 mg/L and 2% CRP > 100 mg/L, where 90%, 22% and 100%, respectively, followed National Institute for Health and Care Excellence (NICE) antibiotic prescribing guidance. Patients reported that CRP testing was comfortable (88%), convenient (84%), useful (92%) and explained well (85%). Patients believed CRP POCT aided clinical diagnosis, provided quick results and reduced unnecessary antibiotic use. Intervention practices had an estimated 21% reduction (95% confidence interval: 0.46-1.35) in the odds of prescribing for cough compared with the controls, a non-significant but clinically relevant reduction.ConclusionsIn routine general practice, CRP POCT use was variable. Non-significant reductions in antibiotic prescribing may reflect small sample size due to non-use of tests. While CRP POCT may be useful, primary care staff need clearer CRP guidance and action planning according to NICE guidance.",2020,"Intervention practices had an estimated 21% reduction (95% confidence interval: 0.46-1.35) in the odds of prescribing for cough compared with the controls, a non-significant but clinically relevant reduction.","['general practices in Northern England', 'patients with acute cough']","['primary care C-reactive protein point-of-care testing', 'CRP POCT', 'C-reactive protein (CRP']","['CRP testing', 'odds of prescribing for cough']","[{'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0742857', 'cui_str': 'Acute cough'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}]",,0.0504935,"Intervention practices had an estimated 21% reduction (95% confidence interval: 0.46-1.35) in the odds of prescribing for cough compared with the controls, a non-significant but clinically relevant reduction.","[{'ForeName': 'Charlotte Victoria', 'Initials': 'CV', 'LastName': 'Eley', 'Affiliation': 'Primary Care Unit, Public Health England, Gloucester, United Kingdom.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'An NHS Clinical Commissioning Group, Greater Manchester, United Kingdom.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'An NHS Clinical Commissioning Group, Greater Manchester, United Kingdom.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Charlett', 'Affiliation': 'Statistics Unit, Public Health England, London, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Owens', 'Affiliation': 'Primary Care Unit, Public Health England, Gloucester, United Kingdom.'}, {'ForeName': 'Cliodna Ann Miriam', 'Initials': 'CAM', 'LastName': 'McNulty', 'Affiliation': 'Primary Care Unit, Public Health England, Gloucester, United Kingdom.'}]",Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin,['10.2807/1560-7917.ES.2020.25.44.1900408']
2220,33153527,Neural Indicators of Anhedonia: Predictors and Mechanisms of Treatment Change in a Randomized Clinical Trial in Early Childhood Depression.,"BACKGROUND
Early childhood depression is associated with anhedonia and reduced event-related potential (ERP) responses to rewarding or pleasant stimuli. Whether these neural measures are indicators of target engagement or treatment outcome is not yet known.
METHODS
We measured ERP responses to win and loss feedback in a guessing task and to pleasant versus neutral pictures in young (4.0-6.9 years of age) depressed children before and after randomization to either 18 weeks of Parent-Child Interaction Therapy-Emotion Development (PCIT-ED) or waitlist.
RESULTS
Analyses included reward positivity (RewP) data from 118 children randomly assigned to PCIT-ED (n = 60) or waitlist (n = 58) at baseline and late positive potential (LPP) data from 99 children (44 assigned to PCIT-ED vs. 55 assigned to waitlist) at baseline. Children undergoing PCIT-ED showed a greater reduction in anhedonia (F 1,103 = 10.32, p = .002, partial η 2 = .09). RewP reward responses increased more (F 1,86 = 5.98, p = .02, partial η 2 = .07) for PCIT-ED, but a greater change in RewP was not significantly associated with a greater reduction in major depressive disorder symptoms (r = -.12, p > .4). Baseline RewP did not predict treatment change. LPPs to positive pictures did not change across treatment, but greater baseline LPPs to positive pictures predicted a higher likelihood of remission from major depressive disorder in children undergoing PCIT-ED (B = 0.14; SE = 0.07; odds ratio = 1.15; p = .03).
CONCLUSIONS
The ERP reward response improved in young children with depression during a treatment designed to enhance emotion development, providing evidence of target engagement of the neural systems associated with reward. Further, greater baseline LPP responses to positive pictures was associated with a greater likelihood of depression remission, suggesting that this ERP measure can predict which children are most likely to respond to treatment.",2020,"Children undergoing PCIT-ED showed a greater reduction in anhedonia (F 1,103 = 10.32, p = .002, partial η 2 = .09).","['in young (4.0-6.9 years of age) depressed children before and after randomization to either 18 weeks of', '118 children randomly assigned to', 'Early Childhood Depression']","['Parent-Child Interaction Therapy-Emotion Development (PCIT-ED) or waitlist', 'guessing task and to pleasant versus neutral pictures', 'PCIT-ED']","['ERP reward response', 'major depressive disorder symptoms', 'anhedonia', 'RewP reward responses', 'ERP responses']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]","[{'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}]",118.0,0.323599,"Children undergoing PCIT-ED showed a greater reduction in anhedonia (F 1,103 = 10.32, p = .002, partial η 2 = .09).","[{'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Barch', 'Affiliation': 'Department of Psychological and Brain Sciences, Washington University in St. Louis, St. Louis, Missouri; Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri; Department of Radiology, Washington University in St. Louis, St. Louis, Missouri. Electronic address: dbarch@wustl.edu.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Whalen', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Gilbert', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Kelly', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Kappenman', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, California.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Hajcak', 'Affiliation': 'Department of Biomedical Science and Psychology, Florida State University, Tallahassee, Florida.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Luby', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri.'}]",Biological psychiatry,['10.1016/j.biopsych.2020.06.032']
2221,33153929,Comparison of 18FDG-PET/CT and conventional follow-up methods in colorectal cancer: A randomised prospective study.,"BACKGROUND
A surveillance program was performed in colorectal cancer (CRC) patients after surgery, to diagnose asymptomatic recurrence.
AIMS
To assess whether 18-FDG positron emission tomography/CT (PET/CT) improved the detection of recurrence during a 3-year follow-up.
METHODS
A multicentre, two-arm randomised prospective trial comparing different 36-month follow-up strategies. Complete colonoscopy was performed at baseline and after 3 years and clinical exams with imaging every 3 months. The conventional arm (A) received carcinoembryonic antigen, liver echography, and alternated between lung radiography and computed tomography (CT) scans. The experimental arm (B) received PET/CT.
RESULTS
A total of 365 patients with colon (79.4%) or rectal cancer (20.6%), stages II (48.2%) or III (50.8%), were enroled in this study. At 36 months, intention-to-treat analysis revealed recurrence in 31 (17.2%) patients in arm A and 47 (25.4%) in arm B (p = 0.063). At 3 years, 7 of 31 relapses (22.5%) in arm A were surgically treated with curative intent, compared to 17 of 47 (36.2%) in arm B (p = 0.25). The rates of recurrence and new cancers were higher in arm B than arm A (p = 0.038).
CONCLUSIONS
PET/CT follow-up every 6 months did not increase the rate of recurrence at 3 years or the rate of surgically treated recurrence compared with conventional follow-up.",2020,"The rates of recurrence and new cancers were higher in arm B than arm A (p = 0.038).
","['colorectal cancer', '365 patients with colon (79.4%) or rectal cancer (20.6%), stages\xa0II (48.2%) or\xa0III (50.8', 'colorectal cancer (CRC) patients after surgery, to diagnose asymptomatic recurrence']","['18FDG-PET/CT and conventional follow-up methods', '18-FDG positron emission tomography/CT (PET/CT', 'PET/CT', 'carcinoembryonic antigen, liver echography, and alternated between lung radiography and computed tomography (CT) scans']","['rate of recurrence', 'rates of recurrence and new cancers']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C5191314', 'cui_str': '48.2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",365.0,0.135152,"The rates of recurrence and new cancers were higher in arm B than arm A (p = 0.038).
","[{'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Monteil', 'Affiliation': 'Department of Nuclear Medicine, University Hospital, Limoges, France.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Le Brun-Ly', 'Affiliation': 'Department of Medical Oncology, University Hospital, Limoges, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Cachin', 'Affiliation': 'Department of Nuclear Medicine, Jean Perrin Cancer Institute, Clermont-Ferrand, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Zasadny', 'Affiliation': 'Department of Radiotherapy, François Chénieux Clinic, Limoges, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Seitz', 'Affiliation': 'Department of Oncology and Hepato-Gastroenterology, University Hospital La Timone, Marseille, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Mundler', 'Affiliation': 'Department of Nuclear Medicine, University Hospital La Timone, Marseille, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Selvy', 'Affiliation': 'Department of Digestive Surgery and Oncology, Estaing Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Department of Digestive Oncology, University Hospital Saint André, Bordeaux, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rullier', 'Affiliation': 'Department of Digestive Surgery, University Hospital Saint André, Bordeaux, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lavau-Denes', 'Affiliation': 'Department of Medical Oncology, University Hospital, Limoges, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lades', 'Affiliation': 'Department of Nuclear Medicine, University Hospital, Limoges, France.'}, {'ForeName': 'Anais', 'Initials': 'A', 'LastName': 'Labrunie', 'Affiliation': 'Department of Biostatistics and Clinical Research, University Hospital, Limoges, France.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Lecaille', 'Affiliation': 'Department of Gastroenterology and Digestive Oncology, Bordeaux Nord Polyclinic, Bordeaux, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Valli', 'Affiliation': 'Department of Nuclear Medicine, Bordeaux Nord Polyclinic, Bordeaux, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Leobon', 'Affiliation': 'Department of Medical Oncology, University Hospital, Limoges, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Terrebonne', 'Affiliation': 'Department of Gastroenterology and Digestive Oncology, University Hospital Haut-Lévêque, Bordeaux, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Deluche', 'Affiliation': 'Department of Medical Oncology, University Hospital, Limoges, France. Electronic address: elise.deluche@chu-limoges.fr.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Tubiana-Mathieu', 'Affiliation': 'Department of Medical Oncology, University Hospital, Limoges, France.'}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.10.012']
2222,33153937,An innovative PantoDict program for reporting panoramic radiographs using automatic speech recognition in dental education: a randomized observer-blinded study.,"OBJECTIVE
The objective of this study was to assess the effect of an e-learning program including automatic speech recognition on outcomes assessment in interpreting panoramic radiographs at a dental school.
STUDY DESIGN
For instruction in reporting findings on panoramic radiographs, 36 participants were divided randomly into 3 seminar groups. Group A used the new PantoDict digital e-learning program for training. Group B used both PantoDict and conventional face-to-face classroom instruction. Group C used conventional instruction only. After attending 3 seminars, all students completed an examination on reporting a panoramic radiograph and evaluated the course.
RESULTS
Both groups using PantoDict (groups A and B) had significantly higher examination scores than the conventional group (P ≤ .002). However, students in group C were more likely than those in group A to agree that their knowledge and confidence improved following the seminars. Students in group A would have preferred an instructor for the first seminar. The evaluation confirmed that students were satisfied with the e-module regarding usability and didactics. Most students indicated that they would like to use PantoDict all the time.
CONCLUSIONS
The e-learning program with automatic speech recognition is a useful device for completing radiology reports and can be used as a complementary tool in face-to-face teaching.",2020,Both groups using PantoDict (groups A and B) had significantly higher examination scores than the conventional group (P ≤ .002).,"['36 participants', 'dental education']","['innovative PantoDict program', 'new PantoDict digital e-learning program for training', 'e-learning program', 'PantoDict and conventional face-to-face classroom instruction']","['examination scores', 'panoramic radiographs']","[{'cui': 'C0013627', 'cui_str': 'Dental Education'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0086858', 'cui_str': 'Programmed Learning'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034579', 'cui_str': 'Orthopantogram'}]",36.0,0.0156345,Both groups using PantoDict (groups A and B) had significantly higher examination scores than the conventional group (P ≤ .002).,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bock', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany. Electronic address: abock@ukaachen.de.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Elvers', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Goloborodko', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Kramer', 'Affiliation': 'Department of Medical Informatics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Kniha', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hölzle', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}, {'ForeName': 'Cord', 'Initials': 'C', 'LastName': 'Spreckelsen', 'Affiliation': 'Institute of Medical Statistics, Computer and Data Sciences, University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Modabber', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2020.10.002']
2223,33153986,Feasibility of using patient-reported outcome measures with visually impaired children/young people attending paediatric ophthalmology clinics.,"OBJECTIVE
To explore feasibility of using child/young person patient-reported outcome measures (PROMs) routinely in practice, using vision-specific instruments and paediatric ophthalmology as the exemplar.
METHODS
Participants comprised patients aged 8-17 years, with visual impairment or low vision (visual acuity of the logarithm of the minimum angle of resolution (logMAR) worse than 0.3 in the better eye), attending the Department of Ophthalmology at Great Ormond Street Hospital, London, UK. All participants completed age-appropriate PROMs before attending their outpatient appointment. Half were randomly assigned to completion at home, with the choice of paper-and-pencil or electronic format. The other half were invited to complete PROMs during their hospital appointment, and randomly assigned to completion format. All participants completed a face-to-face survey exploring their attitudes and preferences. Analysis comprised survival analysis, and direct comparisons of proportions, with complementary qualitative data analysis.
RESULTS
93 patients participated. 48 (98%) completing PROMs at home chose the paper-and-pencil format. Completion at home took longer than at hospital (median=20, vs 14 min, p<0.001). Visual acuity was associated with completion time (p=0.007) and missing data (p=0.03). Overall, 52 (60%) reported a preference for completion at home but there was no clear preference for format (37 (43%) preferred either format).
CONCLUSION
PROM completion at home ahead of hospital appointments may be preferable for collecting complete, high-quality datasets. Despite equipoise on preference for format, the majority of those completing at home chose the traditional paper-and-pencil format, despite impaired sight. These findings should inform implementation of child/young person PROMs into routine practice.",2020,"Completion at home took longer than at hospital (median=20, vs 14 min, p<0.001).","['Participants comprised patients aged 8-17 years, with visual impairment or low vision (visual acuity of the logarithm of the minimum angle of resolution (logMAR) worse than 0.3 in the better eye), attending the Department of Ophthalmology at Great Ormond Street Hospital, London, UK', 'visually impaired children/young people attending paediatric ophthalmology clinics', 'All participants completed age-appropriate PROMs before attending their outpatient appointment', '93 patients participated']",[],['Visual acuity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0442658', 'cui_str': 'Street'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1628978', 'cui_str': 'Pediatric ophthalmology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]",[],"[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",93.0,0.231308,"Completion at home took longer than at hospital (median=20, vs 14 min, p<0.001).","[{'ForeName': 'Alexandra O', 'Initials': 'AO', 'LastName': 'Robertson', 'Affiliation': 'Population, Policy and Practice Research and Teaching Department, UCL Great Ormond Street Institute of Child Health Population Policy and Practice, London, UK.'}, {'ForeName': 'Valerija', 'Initials': 'V', 'LastName': 'Tadić', 'Affiliation': 'School of Human Sciences, University of Greenwich, London, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cortina-Borja', 'Affiliation': 'Population, Policy and Practice Research and Teaching Department, UCL Great Ormond Street Institute of Child Health Population Policy and Practice, London, UK.'}, {'ForeName': 'Jugnoo', 'Initials': 'J', 'LastName': 'Rahi', 'Affiliation': 'Population, Policy and Practice Research and Teaching Department, UCL Great Ormond Street Institute of Child Health Population Policy and Practice, London, UK j.rahi@ucl.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Archives of disease in childhood,['10.1136/archdischild-2020-318991']
2224,33154022,Prognostic role of distant disease-free interval from completion of adjuvant trastuzumab in HER2-positive early breast cancer: analysis from the ALTTO (BIG 2-06) trial.,"BACKGROUND
In HER2-positive breast cancer, time elapsed between completion of (neo)adjuvant trastuzumab and diagnosis of metastatic disease ('trastuzumab-free interval', TFI) is crucial to choose the optimal first-line treatment. Nevertheless, there is no clear evidence to support its possible prognostic role.
METHODS
In the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (ALTTO) trial, patients with HER2-positive early breast cancer were randomised to 1 year of either trastuzumab alone, lapatinib alone, their sequence or their combination. This exploratory analysis included only patients in the trastuzumab alone or trastuzumab plus lapatinib arms who developed a distant disease-free survival (DDFS) event. Overall survival (OS) was defined as time between date of DDFS event and death; age at diagnosis, tumour size and hormone receptor status were the variables included in the multivariate models.
RESULTS
Out of 8381 patients included in ALTTO, 404 patients in the trastuzumab alone and trastuzumab plus lapatinib arms developed a DDFS event, of which 201 occurred < 12 months (group A) and 203 >12 months (group B) after completion of adjuvant trastuzumab. No significant difference in location of first DDFS event was observed (p=0.073); a numerically higher number of patients in group A than in group B developed brain metastasis (26% vs 15%). Choice of first-line therapy differed between the two groups (p=0.022): in group A, more patients received lapatinib (25% vs 11%) and less pertuzumab (8% vs 17%). Median OS was 29.3 and 18.4 months in groups B and A, respectively (adjusted HR 0.69; 95% CI 0.54-0.89; p=0.004). The longer OS for patients in group B was observed across the analysed subgroups without interaction according to hormone receptor status (p=0.814) nor type of administered adjuvant anti-HER2 treatment (p=0.233).
CONCLUSIONS
TFI has prognostic value in patients with HER2-positive early breast cancer treated with adjuvant trastuzumab-based therapy. TFI is a valid tool to better individualise clinical recommendations and to design future first-line treatment trials for metastatic patients.",2020,"Choice of first-line therapy differed between the two groups (p=0.022): in group A, more patients received lapatinib (25% vs 11%) and less pertuzumab (8% vs 17%).","['arms who developed a distant disease-free survival (DDFS) event', 'patients with HER2-positive early breast cancer', 'HER2-positive early breast cancer', 'patients with HER2-positive early breast cancer treated with', 'metastatic patients', '8381 patients included in ALTTO, 404 patients in the']","['trastuzumab alone, lapatinib alone, their sequence or their combination', 'adjuvant trastuzumab', 'trastuzumab alone or trastuzumab plus lapatinib', 'lapatinib', 'TFI', 'trastuzumab alone and trastuzumab plus lapatinib', 'adjuvant trastuzumab-based therapy', 'Adjuvant Lapatinib and/or Trastuzumab']","['Median OS', 'location of first DDFS event', 'brain metastasis', 'Overall survival (OS']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}]",8381.0,0.0778797,"Choice of first-line therapy differed between the two groups (p=0.022): in group A, more patients received lapatinib (25% vs 11%) and less pertuzumab (8% vs 17%).","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lambertini', 'Affiliation': 'Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Genova, Italy matteo.lambertini@unige.it.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Agbor-Tarh', 'Affiliation': 'Frontier Science Scotland, Kingussie, UK.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Metzger-Filho', 'Affiliation': 'Department of Medicine, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Noam F', 'Initials': 'NF', 'LastName': 'Ponde', 'Affiliation': 'Breast Cancer Unit, AC Camargo Cancer Center, Sao Paulo, Brazil.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Poggio', 'Affiliation': 'Breast Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy.'}, {'ForeName': 'Florentine S', 'Initials': 'FS', 'LastName': 'Hilbers', 'Affiliation': 'Breast International Group, Brussels, Belgium.'}, {'ForeName': 'Larissa A', 'Initials': 'LA', 'LastName': 'Korde', 'Affiliation': 'Clinical Investigations Branch, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Saranya', 'Initials': 'S', 'LastName': 'Chumsri', 'Affiliation': 'Oncology Department, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Werner', 'Affiliation': 'Novartis International AG, Basel, Switzerland.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Del Mastro', 'Affiliation': 'Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Genova, Italy.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Caparica', 'Affiliation': ""Medical Oncology Department, Institut Jules Bordet and l'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Moebus', 'Affiliation': 'Medical Clinic II, Department of Hematology/Oncology, University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Oncology Department, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Martine J', 'Initials': 'MJ', 'LastName': 'Piccart', 'Affiliation': ""Medical Oncology Department, Institut Jules Bordet and l'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': ""Medical Oncology Department, Institut Jules Bordet and l'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}]",ESMO open,['10.1136/esmoopen-2020-000979']
2225,33153764,'PDSAFE' - a multi-dimensional model of falls-rehabilitation for people with Parkinson's. A mixed methods analysis of therapists' delivery and experience.,"OBJECTIVE
To explore the clinical reasoning of physiotherapists using PDSAFE; according to disease severity and their experiences of treatment delivery in a large fall-prevention trial for people with Parkinson's (PwP).
DESIGN
A descriptive study of delivering PDSAFE. Semi-structured interviews explored therapists' experiences.
SETTING
A two-group, home-based, multi-centred, single-blinded, randomised controlled trial showed no overall effect on fall reduction between groups but demonstrated a significant secondary effect relating to disease severity with benefits to balance, falls efficacy and near-falls for all.
PARTICIPANTS
Physiotherapists with a background in neurology and older-person rehabilitation were trained in the delivery of PDSAFE INTERVENTION: A multi-dimensional, individually tailored and progressive, home-based programme.
RESULTS
Fifteen physiotherapists contributed to the 2587 intervention sessions from the PDSAFE trial and six of those physiotherapists took part in the interviews. The personalised intervention was reflected in the range of strategies and exercises prescribed. Most commonly prescribed fall-avoidance strategies were 'Avoiding tripping', 'Turning' and 'Freezing Cues' and all possible combinations of balance and strength training within the programme were selected. PwP with greater disease severity were more likely to have received less challenging strategies, balance and strengthening exercises than those with lower disease severity. Therapists considered the focus on fall events and fall avoidance strategies an improvement on 'impairment only' treatment. The presence of cognitive deficits, co-morbidities and dyskinesia were the most challenging aspects of delivering the intervention.
CONCLUSION
Falls management for PwP is complex and compounded by the progressive nature of the condition. Physiotherapists both delivered and positively received PDSAFE. (248 words) The trial registration number is ISRCTN 48152791.",2020,"Most commonly prescribed fall-avoidance strategies were 'Avoiding tripping', 'Turning' and 'Freezing Cues' and all possible combinations of balance and strength training within the programme were selected.","[""people with Parkinson's"", 'Physiotherapists with a background in neurology and older-person rehabilitation', ""people with Parkinson's (PwP""]",['PDSAFE'],"['cognitive deficits, co-morbidities and dyskinesia', 'disease severity with benefits to balance, falls efficacy and near-falls for all']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]",[],"[{'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}]",,0.0444146,"Most commonly prescribed fall-avoidance strategies were 'Avoiding tripping', 'Turning' and 'Freezing Cues' and all possible combinations of balance and strength training within the programme were selected.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hulbert', 'Affiliation': 'University of Exeter. Electronic address: S.hulbert@exeter.ac.uk.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Chivers-Seymour', 'Affiliation': 'Health Sciences, University of Southampton.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Summers', 'Affiliation': 'Health Sciences, University of Southampton.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lamb', 'Affiliation': 'Oxford Clinical Trial Research Unit, University of Oxford.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Goodwin', 'Affiliation': 'University of Exeter.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': 'University of Newcastle.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nieuwboer', 'Affiliation': 'University of Leuven.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rowsell', 'Affiliation': 'Health Sciences, University of Southampton.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ewing', 'Affiliation': 'Health Sciences, University of Southampton.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ashburn', 'Affiliation': 'Health Sciences, University of Southampton.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Physiotherapy,['10.1016/j.physio.2020.08.006']
2226,33153828,Quetiapine treatment for cannabis use disorder.,"BACKROUND
Pharmacotherapy for cannabis use disorder (CUD) is an important unmet public health need.
METHODS
In a 12-week randomized double-blind placebo-controlled trial, the efficacy of quetiapine (300 mg nightly) for the treatment of CUD was tested in 130 outpatients. Weekly cannabis use was categorized into three groups: heavy use (5-7 days), moderate use (2-4 days) and light use (0-1 days).
RESULTS
At baseline both groups were considered heavy users (using days per week: median = 7.0; interquartile range (IQR): 6.5-7.0; daily dollar value: median = $121.4; IQR: 73.8-206.3). The week-by-treatment interaction was marginally significant (χ 2 (2) = 5.56, P = .06). With each week, the odds of moderate compared to heavy use significantly increased in the quetiapine group (OR=1.17, P < .0001), but not significantly in the placebo group (OR=1.05, P = .16). The odds of light versus heavy use did not significantly differ over time (P = .12). Treatment was also associated with reduced cannabis withdrawal symptoms by 10.4% each week (95% CI: 8.9-11.8). No serious adverse events occurred during the study and no evidence of development of a movement disorder was detected. Adverse effects were not significantly different between the quetiapine and placebo treatment arms.
CONCLUSIONS
The use of quetiapine to treat CUD was associated with an increased likelihood of heavy frequency use transitioning to moderate use, but not light use. The clinical significance of reductions in cannabis use, short of abstinence warrants further study.",2020,Treatment was also associated with reduced cannabis withdrawal symptoms by 10.4% each week (95% CI: 8.9-11.8).,['130 outpatients'],"['Quetiapine', 'placebo', 'quetiapine']","['cannabis withdrawal symptoms', 'serious adverse events', 'Adverse effects']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3840212', 'cui_str': 'Cannabis withdrawal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",130.0,0.11501,Treatment was also associated with reduced cannabis withdrawal symptoms by 10.4% each week (95% CI: 8.9-11.8).,"[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Mariani', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY, 10032, USA; Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, 630 West 168th Street, New York, NY, 10032, USA. Electronic address: jm2330@columbia.edu.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, 630 West 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jean Choi', 'Affiliation': 'New York State Psychiatric Institute, Division of Mental Health Data Science, 1051 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Cale', 'Initials': 'C', 'LastName': 'Basaraba', 'Affiliation': 'New York State Psychiatric Institute, Division of Mental Health Data Science, 1051 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Carpenter', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY, 10032, USA; Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, 630 West 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Mahony', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Brooks', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bisaga', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY, 10032, USA; Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, 630 West 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Nasir', 'Initials': 'N', 'LastName': 'Naqvi', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY, 10032, USA; Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, 630 West 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY, 10032, USA; Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, 630 West 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY, 10032, USA; Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, 630 West 168th Street, New York, NY, 10032, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108366']
2227,33153829,Vouchers versus reminders to prevent dropout: Findings from the randomized youth drug abuse treatment project (youthDAT project).,"BACKGROUND
Over the last few decades, evidence-based treatments for emerging adults with drug use disorder (DUD) have been developed, but dropout and inconsistent session attendance persist. This study assessed the efficacy of voucher reinforcement and/or text reminders for treatment attendance and completion in emerging adults with DUD in Denmark.
METHODS
The study compared four levels of treatment intensity, with participants randomly assigned to standard outpatient counseling only (STD), outpatient counseling plus vouchers for attendance (VOU), outpatient counseling plus text reminders (REM), or outpatient counseling plus vouchers and text reminders (REM + VOU). A total of 460 individuals aged 15-25 years seeking treatment for DUD were randomly assigned to the four treatment conditions across nine sites.
RESULTS
STD counseling had the lowest completion rate (25%), followed by REM (39%), VOU (46%), and REM + VOU (49%). Additionally, post hoc comparisons indicated that clients randomized to the REM + VOU condition differed in terms of zero no-shows from clients who were randomized to the VOU condition (χ2(1) = 6.90, p = 0.009) and the REM condition (χ2(1) = 5.87, p = 0.015).
CONCLUSIONS
Vouchers and text reminders contribute to reduced dropout and increased treatment attendance in emerging adults with DUD. The combination of vouchers and reminders in particular has the potential to reduce the number of no-shows.",2020,"A total of 460 individuals aged 15-25 years seeking treatment for DUD were randomly assigned to the four treatment conditions across nine sites.
","['adults with DUD in Denmark', 'adults with drug use disorder (DUD', 'adults with DUD', '460 individuals aged 15-25 years seeking treatment for DUD']","['standard outpatient counseling only (STD), outpatient counseling plus vouchers for attendance (VOU), outpatient counseling plus text reminders (REM), or outpatient counseling plus vouchers and text reminders (REM + VOU', 'voucher reinforcement and/or text reminders']",['lowest completion rate'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",460.0,0.0720138,"A total of 460 individuals aged 15-25 years seeking treatment for DUD were randomly assigned to the four treatment conditions across nine sites.
","[{'ForeName': 'Mads Uffe', 'Initials': 'MU', 'LastName': 'Pedersen', 'Affiliation': 'Centre for Alcohol and Drug Research, Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark. Electronic address: mup.crf@psy.au.dk.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Hesse', 'Affiliation': 'Centre for Alcohol and Drug Research, Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Thylstrup', 'Affiliation': 'Centre for Alcohol and Drug Research, Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Centre for Alcohol and Drug Research, Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Michael Mulbjerg', 'Initials': 'MM', 'LastName': 'Pedersen', 'Affiliation': 'Centre for Alcohol and Drug Research, Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Kirsten Søndergaard', 'Initials': 'KS', 'LastName': 'Frederiksen', 'Affiliation': 'Centre for Alcohol and Drug Research, Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108363']
2228,33154023,Effect of vitamin D supplementation on asthma control in patients with vitamin D deficiency: the ACVID randomised clinical trial.,"BACKGROUND
The relationship between asthma and vitamin D deficiency has been known for some time. However, interventional studies conducted in this regard have shown conflicting results.
OBJECTIVE
To evaluate the efficacy of vitamin D supplementation in asthmatic patients in improving the degree of control of asthma.
METHODS
Randomised, triple-blind, placebo-controlled, parallel-group study in adult asthmatic patients with serum 25-hydroxyvitamin-D 3 <30 ng/mL. The intervention group received oral supplementation with 16 000 IU of calcifediol per week, and the control group had placebo added to their usual asthma treatment. The study period was 6 months. The primary endpoint was the degree of asthma control as determined by the asthma control test (ACT). Secondary endpoints included quality of life measured using the mini Asthma Quality of Life Questionnaire, the number of asthma attacks, oral corticosteroid cycles, the dose of inhaled corticosteroids, number of emergency visits, unscheduled consultations with the primary care physician and hospitalisations for asthma.
RESULTS
One hundred and twelve patients were randomised (mean age 55 years, with 87 (78%) being women). Of the 112 patients, 106 (95%) completed the trial. Half the patients (56) were assigned to the intervention group and the other half to the control group. A statistically significant clinical improvement was observed in the intervention group (+3.09) compared with the control group (-0.57) (difference 3.66 (95% CI 0.89 to 5.43); p<0.001) as measured using ACT scores. Among the secondary endpoints, a significant improvement in the quality of life was found in the intervention group (5.34), compared with the control group (4.64) (difference 0.7 (95% CI 0.15 to 1.25); p=0.01).
CONCLUSION
Among adults with asthma and vitamin D deficiency, supplementation with weekly oral calcifediol compared with placebo improved asthma control over 6 months. Further research is needed to assess long-term efficacy and safety.
TRIAL REGISTRATION NUMBER
NCT02805907.",2020,"Among the secondary endpoints, a significant improvement in the quality of life was found in the intervention group (5.34), compared with the control group (4.64) (difference 0.7 (95% CI 0.15 to 1.25); p=0.01).
","['adults with asthma and vitamin D deficiency, supplementation with weekly', 'patients with vitamin D deficiency', 'adult asthmatic patients with serum 25-hydroxyvitamin-D 3 <30', 'asthmatic patients', 'One hundred and twelve patients were randomised (mean age 55 years, with 87 (78%) being women', '112 patients, 106 (95%) completed the trial']","['vitamin D supplementation', 'oral calcifediol', 'placebo', 'oral supplementation with 16\u2009000\u2009IU of calcifediol']","['degree of asthma control as determined by the asthma control test (ACT', 'quality of life measured using the mini Asthma Quality of Life Questionnaire, the number of asthma attacks, oral corticosteroid cycles, the dose of inhaled corticosteroids, number of emergency visits, unscheduled consultations with the primary care physician and hospitalisations for asthma', 'quality of life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2919855', 'cui_str': 'Mini asthma quality of life questionnaire'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0347950', 'cui_str': 'Acute exacerbation of asthma'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",112.0,0.210825,"Among the secondary endpoints, a significant improvement in the quality of life was found in the intervention group (5.34), compared with the control group (4.64) (difference 0.7 (95% CI 0.15 to 1.25); p=0.01).
","[{'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Andújar-Espinosa', 'Affiliation': 'Pulmonology, Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Murcia, Spain rubemed@hotmail.com.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Salinero-González', 'Affiliation': 'Endocrinology and Nutrition, Hospital General Universitario Reina Sofia, Murcia, Murcia, Spain.'}, {'ForeName': 'Fátima', 'Initials': 'F', 'LastName': 'Illán-Gómez', 'Affiliation': 'Endocrinology and Nutrition, Hospital Morales Meseguer, Murcia, Murcia, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Castilla-Martínez', 'Affiliation': 'Pulmonology, Hospital General Universitario Los Arcos del Mar Menor, Pozo Aledo-San Javier, Murcia, Spain.'}, {'ForeName': 'Chunshao', 'Initials': 'C', 'LastName': 'Hu-Yang', 'Affiliation': 'Pulmonology, Hospital General Universitario Los Arcos del Mar Menor, Pozo Aledo-San Javier, Murcia, Spain.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Ruiz-López', 'Affiliation': 'Pulmonology, Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Murcia, Spain.'}]",Thorax,['10.1136/thoraxjnl-2019-213936']
2229,33154039,Effects of a Tailored Text Messaging Intervention Among Diverse Adults With Type 2 Diabetes: Evidence From the 15-Month REACH Randomized Controlled Trial.,"OBJECTIVE
Text messaging interventions have high potential for scalability and for reductions in health disparities. However, more rigorous, long-term trials are needed. We examined the long-term efficacy and mechanisms of a tailored text messaging intervention.
RESEARCH DESIGN AND METHODS
Adults with type 2 diabetes participated in a parallel-groups, 15-month randomized controlled trial and were assigned to receive Rapid Education/Encouragement and Communications for Health (REACH) for 12 months or control. REACH included interactive texts and tailored texts addressing medication adherence and nontailored texts supporting other self-care behaviors. Outcomes included hemoglobin A 1c (HbA 1c ), diabetes medication adherence, self-care, and self-efficacy.
RESULTS
Participants ( N = 506) were approximately half racial/ethnic minority and half were underinsured, had annual household incomes <$35,000, and had a high school education or less; 11% were homeless. Average baseline HbA 1c was 8.6% ± 1.8%; 70.0 ± 19.7 mmol/mol) with n = 219 having HbA 1c ≥8.5% (69 mmol/mol). Half were prescribed insulin. Retention was over 90%. Median response rate to interactive texts was 91% (interquartile range 75%, 97%). The treatment effect on HbA 1c at 6 months (-0.31%; 95% CI -0.61%, -0.02%) was greater among those with baseline HbA 1c ≥8.5% (-0.74%; 95% CI -1.26%, -0.23%), and there was no evidence of effect modification by race/ethnicity or socioeconomic disadvantage. REACH improved medication adherence and diet through 12 months, and self-efficacy through 6 months. Treatment effects were not significant for any outcome at 15 months. REACH reduced barriers to adherence, but barrier reduction did not mediate outcome improvements.
CONCLUSIONS
REACH engaged at-risk patients in diabetes self-management and improved short-term HbA 1c . More than texts alone may be needed to sustain the effects.",2020,"The treatment effect on HbA 1c at 6 months (-0.31%; 95% CI -0.61%, -0.02%) was greater among those with baseline HbA 1c ≥8.5% (-0.74%; 95% CI -1.26%, -0.23%), and there was no evidence of effect modification by race/ethnicity or socioeconomic disadvantage.","['Adults with type', 'Diverse Adults With Type 2 Diabetes', 'Participants ( N = 506) were approximately half racial/ethnic minority and half were underinsured, had annual household incomes <$35,000, and had a high school education or less; 11% were homeless']","['Tailored Text Messaging Intervention', 'Rapid Education/Encouragement and Communications for Health (REACH) for 12 months or control']","['hemoglobin', 'A 1c (HbA 1c ), diabetes medication adherence, self-care, and self-efficacy', 'Median response rate to interactive texts', 'medication adherence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0087132', 'cui_str': 'Underinsured'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",506.0,0.0721298,"The treatment effect on HbA 1c at 6 months (-0.31%; 95% CI -0.61%, -0.02%) was greater among those with baseline HbA 1c ≥8.5% (-0.74%; 95% CI -1.26%, -0.23%), and there was no evidence of effect modification by race/ethnicity or socioeconomic disadvantage.","[{'ForeName': 'Lyndsay A', 'Initials': 'LA', 'LastName': 'Nelson', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Greevy', 'Affiliation': 'Department of Biostatistics, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spieker', 'Affiliation': 'Department of Biostatistics, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Wallston', 'Affiliation': 'Institute for Medicine and Public Health, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Tom A', 'Initials': 'TA', 'LastName': 'Elasy', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kripalani', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Gentry', 'Affiliation': 'Department of Pharmacy, College of Pharmacy and Health Sciences, Lipscomb University, Nashville, TN.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Bergner', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'LeStourgeon', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Williamson', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Lindsay S', 'Initials': 'LS', 'LastName': 'Mayberry', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN lindsay.mayberry@vumc.org.'}]",Diabetes care,['10.2337/dc20-0961']
2230,33154056,Expanding the upper age limit for cervical cancer screening: a protocol for a nationwide non-randomised intervention study.,"INTRODUCTION
Cervical cancer screening ceases between the ages of 60 and 65 in most countries. Yet, a relatively high proportion of cervical cancers are diagnosed in women above the screening age. This study will evaluate if screening of women aged 65-69 years may result in increased detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared with women not invited to screening. Invited women may choose between general practitioner (GP)-based screening or cervico-vaginal self-sampling. Furthermore, the study will assess if self-sampling is superior to GP-based screening in reaching long-term unscreened women.
METHODS AND ANALYSIS
This population-based non-randomised intervention study will include 10 000 women aged 65-69 years, with no record of a cervical cytology sample or screening invitation in the 5 years before inclusion. Women who have opted-out of the screening programme or have a record of hysterectomy or cervical amputation are excluded. Women residing in the Central Denmark Region (CDR) are allocated to the intervention group, while women residing in the remaining four Danish regions are allocated to the reference group. The intervention group is invited for human papillomavirus-based screening by attending routine screening at the GP or by requesting a self-sampling kit. The reference group receives standard care which is the opportunity to have a cervical cytology sample obtained at the GP or by a gynaecologist. The study started in April 2019 and will run over the next 4.5 years. The primary outcome will be the proportion of CIN2+ detected in the intervention and reference groups. In the intervention group, the proportion of long-term unscreened women attending GP-based screening or self-sampling will be compared.
ETHICS AND DISSEMINATION
The study has been submitted to the Ethical Committee in the CDR which deemed that the study was not notifiable to the Committee and informed consent is therefore not required. The study is approved by the Danish Data Protection Regulation and the Danish Patient Safety Authority. Results will be disseminated in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT04114968.",2020,This study will evaluate if screening of women aged 65-69 years may result in increased detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared with women not invited to screening.,"['women aged 65-69 years', 'Cervical cancer screening ceases between the ages of 60 and 65 in most countries', '10\u2009000 women aged 65-69 years, with no record of a cervical cytology sample or screening invitation in the 5 years before inclusion', 'Women who have opted-out of the screening programme or have a record of hysterectomy or cervical amputation are excluded', 'Women residing in the Central Denmark Region (CDR']","['general practitioner (GP)-based screening or cervico-vaginal self-sampling', 'human papillomavirus-based screening by attending routine screening at the GP or by requesting a self-sampling kit']","['detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2', 'proportion of CIN2']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0332127', 'cui_str': 'No record of'}, {'cui': 'C0856201', 'cui_str': 'Cervical cytology'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205064', 'cui_str': 'Cervical'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",10000.0,0.0777577,This study will evaluate if screening of women aged 65-69 years may result in increased detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared with women not invited to screening.,"[{'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Tranberg', 'Affiliation': 'Department of Public Health Programmes, Randers Regional Hospital, Randers, Denmark mettrani@rm.dk.'}, {'ForeName': 'Lone Kjeld', 'Initials': 'LK', 'LastName': 'Petersen', 'Affiliation': 'Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Klara Miriam', 'Initials': 'KM', 'LastName': 'Elfström', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hammer', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Blaakær', 'Affiliation': 'Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Mary Holten', 'Initials': 'MH', 'LastName': 'Bennetsen', 'Affiliation': 'Department of Pathology, Regional Hospital Randers, Randers, Denmark.'}, {'ForeName': 'Jørgen Skov', 'Initials': 'JS', 'LastName': 'Jensen', 'Affiliation': 'Research Unit for Reproductive Microbiology, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Andersen', 'Affiliation': 'Department of Public Health Programmes, Randers Regional Hospital, Randers, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-039636']
2231,33154058,Rotator cuff-related shoulder pain: does the type of exercise influence the outcomes? Protocol of a randomised controlled trial.,"INTRODUCTION
Lifetime prevalence of shoulder pain is 70%, and approximately 50% of people with shoulder pain will experience pain for more than a year. Rotator cuff-related shoulder pain (RCRSP) is the most common shoulder condition and the main non-surgical intervention is exercise therapy. For approximately 30% of people with RCRSP, this approach does not lead to a significant reduction in symptoms. This may be due to an inappropriate dosage or choice of exercises. The aim of this investigation is to compare the short, mid and long-term effects, in terms of symptoms, functional limitations, kinesiophobia and pain catastrophising, of three different shoulder rehabilitation approaches (education, strengthening, motor control) in adults with RCRSP.
METHODS AND ANALYSIS
In this single-blind (assessor), parallel-group, randomised clinical trial, 123 adults presenting with RCRSP will take part in a 12-week rehabilitation programme. They will be randomly assigned to one of three groups (education only, strengthening approach or motor control-focused approach). Abbreviated version of the Disabilities of the Arm, Shoulder and Hand Questionnaire, the primary outcome, Western Ontario Rotator Cuff Index and Brief Pain Inventory will evaluate symptoms and functional limitations, while Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale will evaluate pain-related fear and catastrophising at baseline and at 3, 6, 12 and 24 weeks. Ultrasonographic acromiohumeral distances and tendon thickness will be assessed at baseline and 12 weeks. Intervention groups will be compared on outcomes with intention-to-treat analyses using two-way repeated measures analysis of variance if the data are normally distributed or non-parametric analysis of longitudinal data if they are not.
ETHICS AND DISSEMINATION
Ethics approval was obtained from the Sectorial Rehabilitation and Social Integration Research Ethics Committee of the Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale Nationale (CIUSSS-CN). Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations.
TRIAL REGISTRATION NUMBER
NCT03892603; pre-results.",2020,"Abbreviated version of the Disabilities of the Arm, Shoulder and Hand Questionnaire, the primary outcome, Western Ontario Rotator Cuff Index and Brief Pain Inventory will evaluate symptoms and functional limitations, while Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale will evaluate pain-related fear and catastrophising at baseline and at 3, 6, 12 and 24 weeks.","['123 adults presenting with RCRSP will take part in a 12-week rehabilitation programme', 'adults with RCRSP']","['Rotator cuff-related shoulder pain (RCRSP', 'strengthening approach or motor control-focused approach']","['Ultrasonographic acromiohumeral distances and tendon thickness', 'Lifetime prevalence of shoulder pain', 'Western Ontario Rotator Cuff Index and Brief Pain Inventory will evaluate symptoms and functional limitations, while Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale will evaluate pain-related fear and catastrophising', 'Rotator cuff-related shoulder pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",123.0,0.336619,"Abbreviated version of the Disabilities of the Arm, Shoulder and Hand Questionnaire, the primary outcome, Western Ontario Rotator Cuff Index and Brief Pain Inventory will evaluate symptoms and functional limitations, while Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale will evaluate pain-related fear and catastrophising at baseline and at 3, 6, 12 and 24 weeks.","[{'ForeName': 'Marc-Olivier', 'Initials': 'MO', 'LastName': 'Dubé', 'Affiliation': 'Department of Rehabilitation, Faculty of Medicine, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Desmeules', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Lewis', 'Affiliation': 'School of Health and Social Work, University of Hertfordshire, Hatfield, UK.'}, {'ForeName': 'Jean-Sébastien', 'Initials': 'JS', 'LastName': 'Roy', 'Affiliation': 'Department of Rehabilitation, Faculty of Medicine, Université Laval, Quebec City, Quebec, Canada jean-sebastien.roy@fmed.ulaval.ca.'}]",BMJ open,['10.1136/bmjopen-2020-039976']
2232,33154283,Comparison of rubber band ligation with 3% polidocanol injection sclerotherapy for the treatment of internal haemorrhoids at a Nigerian tertiary hospital.,"Background
The surgical treatment of internal haemorrhoids is yet to be fully elucidated. Rubber band ligation (RBL) and injection sclerotherapy (IS) are less invasive alternative day-case treatment options with lower morbidity than excisional haemorrhoidectomy.
Aims
This was a prospective study that compared the efficacy of RBL with 3% polidocanol IS in the treatment of Grades I to III internal haemorrhoids.
Patients and Methods
Sodergren haemorrhoid symptom severity (SHSS) scores of consecutive adult patients with internal haemorrhoids were calculated before and after each of three therapy sessions with RBL and IS. Outcome measures included SHSS scores after treatment, post-procedure pain and complication rates. Data were collated and analysed using SPSS version 23.
Results
A total of 74 patients participated in the study with 37 patients in each treatment group. The RBL and IS groups were not statistically different in age (P = 0.506), weight (P = 0.117), height (P = 0.462), BMI (P = 0.153) and gender (P = 0.639). The mean SHSS scores for both groups before therapy (P = 0.876), at 4 weeks (P = 0.669), 8 weeks (P = 0.168) and 12 weeks (P = 0.391) after commencement of therapy were not statistically different. The SHSS scores at 12 weeks after treatment were statistically significantly lower than before treatment in both the groups (P < 0.01). The post-procedure pain score was significantly higher in the RBL than IS group after the first (P < 0.001) and second (P < 0.006) but not after the third therapy session (P = 0.501). The complication rates were low and not significantly different for the RBL and IS groups (5.7% versus 8.1%; P = 0.643).
Conclusion
The study concluded that RBL and IS are both effective and safe in the treatment of Grades I, II and III internal haemorrhoids.",2020,"The mean SHSS scores for both groups before therapy (P = 0.876), at 4 weeks (P = 0.669), 8 weeks (P = 0.168) and 12 weeks (P = 0.391) after commencement of therapy were not statistically different.","['74 patients participated in the study with 37 patients in each treatment group', 'internal haemorrhoids at a Nigerian tertiary hospital']","['Rubber band ligation (RBL) and injection sclerotherapy (IS', 'rubber band ligation with 3% polidocanol injection sclerotherapy', 'polidocanol']","['BMI', 'SHSS scores', 'weight', 'post-procedure pain score', 'SHSS scores after treatment, post-procedure pain and complication rates', 'complication rates', 'mean SHSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0265034', 'cui_str': 'Internal hemorrhoids'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C4047030', 'cui_str': 'polidocanol Injection [Asclera]'}, {'cui': 'C0071330', 'cui_str': 'polidocanol'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",74.0,0.0235545,"The mean SHSS scores for both groups before therapy (P = 0.876), at 4 weeks (P = 0.669), 8 weeks (P = 0.168) and 12 weeks (P = 0.391) after commencement of therapy were not statistically different.","[{'ForeName': 'Ayomide', 'Initials': 'A', 'LastName': 'Makanjuola', 'Affiliation': 'Department of Surgery, General Surgery Unit, Lagos University Teaching Hospital, Idi-Araba, Lagos, Nigeria.'}, {'ForeName': 'Olanrewaju Solomon', 'Initials': 'OS', 'LastName': 'Balogun', 'Affiliation': 'Department of Surgery, General Surgery Unit, Lagos University Teaching Hospital; Department of Surgery, College of Medicine, University of Lagos, Idi-Araba, Lagos, Nigeria.'}, {'ForeName': 'Adedapo Olumide', 'Initials': 'AO', 'LastName': 'Osinowo', 'Affiliation': 'Department of Surgery, General Surgery Unit, Lagos University Teaching Hospital; Department of Surgery, College of Medicine, University of Lagos, Idi-Araba, Lagos, Nigeria.'}, {'ForeName': 'Adedoyin Adekunle', 'Initials': 'AA', 'LastName': 'Adesanya', 'Affiliation': 'Department of Surgery, General Surgery Unit, Lagos University Teaching Hospital; Department of Surgery, College of Medicine, University of Lagos, Idi-Araba, Lagos, Nigeria.'}, {'ForeName': 'John Taiwo', 'Initials': 'JT', 'LastName': 'da Rocha', 'Affiliation': 'Department of Surgery, College of Medicine, University of Lagos, Idi-Araba, Lagos, Nigeria.'}]",The Nigerian postgraduate medical journal,['10.4103/npmj.npmj_232_20']
2233,33154284,Efficacy of nifedipine versus hydralazine in the management of severe hypertension in pregnancy: A randomised controlled trial.,"Background
Despite the availability of effective antihypertensive drugs, the quality of evidence regarding the best antihypertensive agent for the treatment of hypertensive emergencies in pregnancy is still poor.
Aim
The aim of this study was to compare the efficacy and side effects of oral nifedipine and intravenous hydralazine for control of blood pressure (BP) in severe hypertension in pregnancy.
Materials and Methods
An open-label, parallel, randomised, controlled trial of 78 pregnant women (≥28 weeks' gestation) with severe hypertension was conducted. Severe hypertension was defined as systolic BP of 160 mmHg or above and/or diastolic BP of 110 mmHg or above. They were randomly (1:1 ratio) administered oral nifedipine 20 mg or intravenous hydralazine 10 mg every 30 min up to 5 doses or until the target BP of 140-150 mmHg systolic and 90-100 mmHg diastolic was achieved. Intravenous labetalol was given if the primary treatment failed. The primary outcome measure was the number of doses needed to achieve targeted BP. The secondary outcome measures were the time needed to achieve desired BP, maternal adverse effects and perinatal outcome.
Results
The sociodemographic characteristics did not differ between the two study groups. The average number of dosages (nifedipine; 1.4 ± 0.6 vs. hydralazine; 1.7 ± 0.5, P = 0.008) needed to control the BP was lower in the nifedipine arm. Time (min) taken to control the BP was similar between the groups (hydralazine; 43.7 ± 19.7 vs. nifedipine; 51.2 ± 18.9, P = 0.113). Adverse maternal and perinatal effects did not differ in the study groups.
Conclusion
Oral nifedipine and intravenous hydralazine showed comparable efficacy in the BP control in the severe hypertensive disorders of pregnancy without significant difference in adverse maternal and perinatal outcomes. However, further studies are required to explore the role of these drugs in BP control during hypertensive emergencies in pregnancy.
ClinicalTrials.gov
(Identification number: NCT04435210).",2020,"Conclusion
Oral nifedipine and intravenous hydralazine showed comparable efficacy in the BP control in the severe hypertensive disorders of pregnancy without significant difference in adverse maternal and perinatal outcomes.","['severe hypertension in pregnancy', ""78 pregnant women (≥28 weeks' gestation) with severe hypertension was conducted""]","['nifedipine', 'oral nifedipine 20 mg or intravenous hydralazine 10 mg', 'Intravenous labetalol', 'hydralazine']","['time needed to achieve desired BP, maternal adverse effects and perinatal outcome', 'adverse maternal and perinatal outcomes', 'blood pressure (BP', 'systolic BP of 160 mmHg or above and/or diastolic BP', 'number of doses needed to achieve targeted BP', 'Time (min) taken to control the BP', 'efficacy and side effects', 'Severe hypertension', 'Adverse maternal and perinatal effects']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0565599', 'cui_str': 'Maternal hypertension'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0988141', 'cui_str': 'Nifedipine 20 MG'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0020223', 'cui_str': 'Hydralazine'}, {'cui': 'C0022860', 'cui_str': 'Labetalol'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",78.0,0.115559,"Conclusion
Oral nifedipine and intravenous hydralazine showed comparable efficacy in the BP control in the severe hypertensive disorders of pregnancy without significant difference in adverse maternal and perinatal outcomes.","[{'ForeName': 'Joshua Adeniyi', 'Initials': 'JA', 'LastName': 'Adebayo', 'Affiliation': 'Department of Obstetrics and Gynaecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}, {'ForeName': 'Johnbosco Ifunanya', 'Initials': 'JI', 'LastName': 'Nwafor', 'Affiliation': 'Department of Obstetrics and Gynaecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}, {'ForeName': 'Lucky Osaheni', 'Initials': 'LO', 'LastName': 'Lawani', 'Affiliation': 'Department of Obstetrics and Gynaecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}, {'ForeName': 'Chidi Ochu', 'Initials': 'CO', 'LastName': 'Esike', 'Affiliation': 'Department of Obstetrics and Gynaecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}, {'ForeName': 'Ayodele Adegbite', 'Initials': 'AA', 'LastName': 'Olaleye', 'Affiliation': 'Department of Obstetrics and Gynaecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}, {'ForeName': 'Nnabugwu Alfred', 'Initials': 'NA', 'LastName': 'Adiele', 'Affiliation': 'Department of Obstetrics and Gynaecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}]",The Nigerian postgraduate medical journal,['10.4103/npmj.npmj_275_20']
2234,33154288,Effectiveness of audio-visual and print media intervention on knowledge of cervical health among rural women in Southern India.,"Background
Cervical cancer health education programmes are not accessible to rural women in developing countries.
Objective
Our study aimed at assessing the health literacy about cervical cancer amongst the rural women in Udupi district, southern India, before and following intervention using audio-visual aid/face-to-face interactive sessions versus pamphlets alone.
Methods
This was a quasi-experimental study. A total of 166 women participated in the study. Participant groups were allocated into two interventional (Experimental/Control) groups. Participants in the experimental group received education through the video followed by face-to-face interaction with a health educator while those in the control group received a pamphlet. A validated questionnaire was used to assess knowledge about numerous risk factors, Pap smear test and treatment of cervical cancer (pre- and post-intervention test). The findings are presented as frequencies and percentages. Paired responses were compared for individual questions using McNemar test and P < 0.05 was fixed as statistically significant.
Results
Former to the intervention, 13.5% and 19.1% in the experimental and control groups, respectively, felt that personal hygiene was important to prevent cervical cancer. Both the groups had very limited knowledge regarding risk factors (93.6%; 94%), symptoms (96.3%; 97.6%) and knowledge that Pap smears can reduce the risk of cervical cancer (91.7%; 93.9%). The change in knowledge pre-and post-intervention in both groups increased significantly.
Conclusion
Intervention with face-to-face interactive sessions showed a positive impact on knowledge regarding cervical cancer. These findings indicate both methods can be effective in providing health education in the community.",2020,"Both the groups had very limited knowledge regarding risk factors (93.6%; 94%), symptoms (96.3%; 97.6%) and knowledge that Pap smears can reduce the risk of cervical cancer (91.7%; 93.9%).","['166 women participated in the study', 'rural women in developing countries', 'rural women in Southern India', 'rural women in Udupi district, southern India, before and following']","['education through the video followed by face-to-face interaction with a health educator while those in the control group received a pamphlet', 'audio-visual and print media intervention', 'intervention using audio-visual aid/face-to-face interactive sessions versus pamphlets alone']","['knowledge of cervical health', 'risk of cervical cancer', 'knowledge regarding cervical cancer']","[{'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011750', 'cui_str': 'Less-Developed Countries'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1136362', 'cui_str': 'Health educator'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0033159', 'cui_str': 'Printed Media'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004282', 'cui_str': 'Audio-Visual Aids'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}]",166.0,0.0249805,"Both the groups had very limited knowledge regarding risk factors (93.6%; 94%), symptoms (96.3%; 97.6%) and knowledge that Pap smears can reduce the risk of cervical cancer (91.7%; 93.9%).","[{'ForeName': 'Takkella', 'Initials': 'T', 'LastName': 'Nagamma', 'Affiliation': 'Department of Biochemistry, Melaka Manipal Medical College (Manipal Campus), Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Ashok', 'Affiliation': 'Department of Global Health, Prasanna School of Public Health, MSW Program, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Anjaneyulu', 'Initials': 'A', 'LastName': 'Konuri', 'Affiliation': 'Department of Anatomy, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Varalakshmi', 'Initials': 'V', 'LastName': 'Chandrasekaran', 'Affiliation': 'Department of Community Medicine, Melaka Manipal Medical College (Manipal Campus), Manipal Academy of Higher Education, Manipal, Karnataka, India.'}]",The Nigerian postgraduate medical journal,['10.4103/npmj.npmj_148_20']
2235,33154429,Electronic health record alerts enhance mass screening for chronic hepatitis B.,"To measure the effect of an electronic health record (EHR) alert on chronic hepatitis B (CHB) screening among at-risk Asian and Pacific Islanders (API). API patients who had not yet completed hepatitis B surface antigen (HBsAg) testing were identified by a novel EHR-based population health tool. At-risk API patients in Cohort 1 (primarily privately insured) and Cohort 2 (includes Medicare and/or Medicaid) were randomized to alert activation in their electronic medical charts or not. In total, 8299 API were found to be deficient in HBsAg completion at baseline within our health system. In Cohort 1, 1542 patients and 1568 patients were randomized to the alert and control respectively. In Cohort 2, 2599 patients and 2590 patients were randomized to the alert and control respectively. For both cohorts combined, 389 HBsAg tests were completed in the alert group compared to 177 HBsAg tests in the control group (p < 0.0001; OR = 2.3; 95% CI 1.94-2.80), but there was no increased detection of HBsAg positivity from the alert (15 versus 13 respectively, p = 0.09; OR = 0.5; 95% CI 0.24-1.09). Our results demonstrate that personalized, automated electronic alerts increase screening for CHB, but more comprehensive measures are needed to detect HBsAg positive patients.NIH Trial Registry Number: NCT04240678.",2020,"For both cohorts combined, 389 HBsAg tests were completed in the alert group compared to 177 HBsAg tests in the control group (p < 0.0001; OR = 2.3; 95% CI 1.94-2.80), but there was no increased detection of HBsAg positivity from the alert (15 versus 13 respectively, p = 0.09; OR = 0.5; 95% CI 0.24-1.09).","['At-risk API patients in Cohort 1 (primarily privately insured) and Cohort 2 (includes Medicare and/or Medicaid', '2599 patients and 2590 patients', 'chronic hepatitis B', 'chronic hepatitis B (CHB) screening among at-risk Asian and Pacific Islanders (API', 'API patients who had not yet completed hepatitis B surface antigen ', '1542 patients and 1568 patients']","['electronic health record (EHR) alert', 'Electronic health record alerts enhance mass screening']","['detection of HBsAg positivity', 'HBsAg completion']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0242191', 'cui_str': 'Pacific Island Americans'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}]","[{'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0024870', 'cui_str': 'Mass Screening'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",8299.0,0.0903795,"For both cohorts combined, 389 HBsAg tests were completed in the alert group compared to 177 HBsAg tests in the control group (p < 0.0001; OR = 2.3; 95% CI 1.94-2.80), but there was no increased detection of HBsAg positivity from the alert (15 versus 13 respectively, p = 0.09; OR = 0.5; 95% CI 0.24-1.09).","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Chak', 'Affiliation': 'Division of Gastroenterology and Hepatology, UC Davis School of Medicine, 4150 V Street, PSSB 3500, Sacramento, CA, USA. echak@ucdavis.edu.'}, {'ForeName': 'Chin-Shang', 'Initials': 'CS', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The State University of New York, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Moon S', 'Initials': 'MS', 'LastName': 'Chen', 'Affiliation': 'Division of Hematology and Oncology, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'MacDonald', 'Affiliation': 'Division of Clinical Informatics, UC Davis Medical Center, Sacramento, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bowlus', 'Affiliation': 'Division of Gastroenterology and Hepatology, UC Davis School of Medicine, 4150 V Street, PSSB 3500, Sacramento, CA, USA.'}]",Scientific reports,['10.1038/s41598-020-75842-8']
2236,33154508,"Reduced levels of biomarkers of exposure in smokers switching to the Carbon-Heated Tobacco Product 1.0: a controlled, randomized, open-label 5-day exposure trial.","In addition to smoking cessation, for those who would otherwise continue to smoke, replacing cigarettes with less harmful alternatives can reduce the harms of smoking. Heating instead of burning tobacco reduces, or eliminates, the formation of harmful and potentially harmful constituents (HPHC) that are found in cigarette smoke. The Carbon-Heated Tobacco Product (CHTP), a heat-not-burn tobacco product, mimics the cigarette smoking ritual. This randomized, open-label, two-arm, parallel-group, short-term confinement study tested the hypothesis that the geometric means of the BoExp levels for subjects switching to CHTP 1.0 for 5 days are lower relative to those continuing to smoke cigarettes. Biomarkers of exposure (BoExp), including nicotine, urinary excretion of mutagenic constituents (Ames test), and cytochrome P450 (CYP) 1A2 activity, were measured in blood and/or 24-h urine samples during ad libitum product use. Nicotine exposure remained at similar levels in individuals using CHTP as in those continuing to smoke cigarettes. Switching to CHTP resulted in marked decreases in all other urinary BoExp (56-97%), carboxyhemoglobin (59%), urinary mutagenic constituents, and CYP1A2 activity compared with continued cigarette smoking. Our results provide evidence of decreased exposure to 15 selected HPHCs in smokers switching from cigarettes to exclusive CHTP use.Trial registration ClinicalTrials.gov: NCT02503254; Date of first registration: 20/07/2015 https://www.clinicaltrials.gov/ct2/show/NCT02503254 .Study protocol Study protocol published at: https://www.clinicaltrials.gov/ProvidedDocs/54/NCT02503254/Prot_000.pdf .",2020,"Switching to CHTP resulted in marked decreases in all other urinary BoExp (56-97%), carboxyhemoglobin (59%), urinary mutagenic constituents, and CYP1A2 activity compared with continued cigarette smoking.",[],"['CHTP', 'Carbon-Heated Tobacco Product (CHTP', 'Nicotine']","['nicotine, urinary excretion of mutagenic constituents (Ames test), and cytochrome P450 (CYP) 1A2 activity', 'formation of harmful and potentially harmful constituents (HPHC', 'urinary BoExp', 'urinary mutagenic constituents, and CYP1A2 activity']",[],"[{'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008381', 'cui_str': 'Cholesterol monooxygenase (side-chain cleaving)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0207509', 'cui_str': 'Cytochrome p450 CYP1A2 enzyme'}]",,0.0309428,"Switching to CHTP resulted in marked decreases in all other urinary BoExp (56-97%), carboxyhemoglobin (59%), urinary mutagenic constituents, and CYP1A2 activity compared with continued cigarette smoking.","[{'ForeName': 'Cam Tuan', 'Initials': 'CT', 'LastName': 'Tran', 'Affiliation': 'PMI Science & Innovation, Philip Morris Products S.A., Quai Jeanrenaud 5, 2000, Neuchâtel, Switzerland. CamTuan.Tran@pmi.com.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Bosilkovska', 'Affiliation': 'PMI Science & Innovation, Philip Morris Products S.A., Quai Jeanrenaud 5, 2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'de La Bourdonnaye', 'Affiliation': 'PMI Science & Innovation, Philip Morris Products S.A., Quai Jeanrenaud 5, 2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Blanc', 'Affiliation': 'PMI Science & Innovation, Philip Morris Products S.A., Quai Jeanrenaud 5, 2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Haziza', 'Affiliation': 'PMI Science & Innovation, Philip Morris Products S.A., Quai Jeanrenaud 5, 2000, Neuchâtel, Switzerland.'}]",Scientific reports,['10.1038/s41598-020-76222-y']
2237,33154570,"FOLFIRI plus cetuximab or bevacizumab for advanced colorectal cancer: final survival and per-protocol analysis of FIRE-3, a randomised clinical trial.","BACKGROUND
Cetuximab plus FOLFIRI improved overall survival compared with bevacizumab plus FOLFIRI in KRAS wild-type metastatic colorectal cancer (mCRC) in FIRE-3, but no corresponding benefit was found for progression-free survival. This analysis aimed to determine whether cetuximab improves response and survival versus bevacizumab among response-evaluable patients receiving first-line FOLFIRI for RAS wild-type mCRC and the effect of primary tumour side on outcomes.
METHODS
The intent-to-treat population included 593 patients with KRAS exon 2 wild-type mCRC. Further testing identified 400 patients with extended RAS wild-type disease; of these, 352 (88%) who received ≥3 cycles of therapy and had ≥1 post-baseline scan were evaluable for response and constituted the per-protocol population (169 cetuximab and 183 bevacizumab). Patients received 5-fluorouracil, folinic acid and irinotecan (FOLFIRI) with either weekly cetuximab or biweekly bevacizumab given on day 1 of each 14-day cycle until response, progression or toxicity occurred. The primary endpoint was the objective response rate (ORR) in the per-protocol population. Secondary endpoints included overall survival (OS) and progression-free survival (PFS). The effect of primary tumour location was evaluated.
RESULTS
Median OS in the RAS wild-type population was 31 vs 26 months in the cetuximab and bevacizumab groups, respectively (HR 0.76, P = 0.012). In the per-protocol population, outcomes favoured cetuximab for ORR (77% vs 65%, P = 0.014) and median OS (33 vs 26 months, HR 0.75, P = 0.011), while PFS was comparable between groups. The advantage of cetuximab over bevacizumab occurred only in patients with left-sided primary tumours.
CONCLUSIONS
FOLFIRI plus cetuximab resulted in a significantly higher ORR and longer OS compared to FOLFIRI plus bevacizumab among patients with left-sided tumours. The superior response associated with cetuximab may particularly benefit patients with symptomatic tumours or borderline-resectable metastases. CLINICALTRIALS.
GOV IDENTIFIER
NCT00433927.",2020,"RESULTS
Median OS in the RAS wild-type population was 31 vs 26 months in the cetuximab and bevacizumab groups, respectively (HR 0.76, P = 0.012).","['patients with left-sided primary tumours', '400 patients with extended RAS wild-type disease; of these, 352 (88%) who received ≥3 cycles of therapy and had ≥1 post-baseline scan were evaluable for response and constituted the per-protocol population (169 cetuximab and 183 bevacizumab', '593 patients with KRAS exon 2 wild-type mCRC', 'patients with symptomatic tumours or borderline-resectable metastases', 'advanced colorectal cancer', 'patients with left-sided tumours', 'response-evaluable patients receiving first-line FOLFIRI for RAS wild-type mCRC']","['bevacizumab plus FOLFIRI', 'FOLFIRI plus bevacizumab', 'FOLFIRI plus cetuximab or bevacizumab', 'bevacizumab', 'cetuximab', '5-fluorouracil, folinic acid and irinotecan (FOLFIRI) with either weekly cetuximab or biweekly bevacizumab']","['objective response rate (ORR', 'overall survival (OS) and progression-free survival (PFS', 'ORR and longer OS', 'ORR', 'median OS', 'PFS', 'response and survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",593.0,0.203293,"RESULTS
Median OS in the RAS wild-type population was 31 vs 26 months in the cetuximab and bevacizumab groups, respectively (HR 0.76, P = 0.012).","[{'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich, Germany. Volker.heinemann@med.uni-muenchen.de.'}, {'ForeName': 'Ludwig Fischer', 'Initials': 'LF', 'LastName': 'von Weikersthal', 'Affiliation': 'Gesundheitszentrum St. Marien, Amberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Decker', 'Affiliation': 'Onkologie Ravensburg, Ravensburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kiani', 'Affiliation': 'Klinik Herzoghöhe, Bayreuth, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'Oncological Practice, Landshut, Germany.'}, {'ForeName': 'Salah-Edin', 'Initials': 'SE', 'LastName': 'Al-Batran', 'Affiliation': 'Institute of Clinical Cancer Research at Krankenhaus Nordwest University Cancer Center, Frankfurt, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Heintges', 'Affiliation': 'Department of Medicine II, Städtische Kliniken Neuss, Neuss, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Lerchenmüller', 'Affiliation': 'Oncological Practice, Münster, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kahl', 'Affiliation': 'Department of Haematology and Oncology, Städtisches Klinikum Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Seipelt', 'Affiliation': 'Oncological Practice, Bad Soden, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kullmann', 'Affiliation': 'Department of Medicine I, Klinikum Weiden, Weiden, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'Department of Medicine II, University Hospital, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Scheithauer', 'Affiliation': 'Department of Internal Medicine I and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess GmbH, Leverkusen, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Miller-Phillips', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich, Germany.'}, {'ForeName': 'Dominik Paul', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jung', 'Affiliation': 'Institute of Pathology, University of Munich, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kirchner', 'Affiliation': 'Institute of Pathology, University of Munich, Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Division of Hematology, Oncology, and Tumor Immunology (CCM), Department of Medicine, Charité Universitaetsmedizin Berlin, Berlin, Germany.'}]",British journal of cancer,['10.1038/s41416-020-01140-9']
2238,33154619,Multifocal ERG and Microperimetry Changes in Response to Ranibizumab Treatment of Neovascular AMD: Randomized Phase 2 Open-Label Study.,"Purpose
To compare monthly versus pro re nata (PRN) ranibizumab injections in the treatment of exudative macular degeneration (AMD) while assessing the utility of microperimetry (MP) and multifocal electroretinography (mfERG) testing when monitoring response to treatment.
Methods
A randomized exploratory trial comparing the efficacy of monthly versus PRN dosing of ranibizumab (0.5 mg or 2.0 mg) for patients with exudative AMD over 12 months. High-resolution optical coherence tomography (HR-OCT) studies were used to guide PRN treatment and any cystic spaces or subretinal fluid prompted retreatment. Macular function was assessed using mean sensitivity on MP and N1-P1 response density on mfERG. Best-corrected visual acuity (BCVA) was measured with Early Treatment Diabetic Retinopathy Study (ETDRS) letters and anatomic response assessed with central foveal thickness (CFT) using HR-OCT studies.
Results
The 12-month study was completed by 43 patients in the PRN cohort and 33 patients in the monthly cohort. Mean BCVA improved by 6.0 ± 1.3 ETDRS letters in the PRN cohort compared to 7.3 ± 2.8 ETDRS letters in the monthly cohort (p=0.68). A reduction in mean CFT of 64.5 ± 13.3 and 96.3 ± 22.0 µm occurred in the PRN and monthly cohorts, respectively (p=0.22). Macular function assessed with mfERG decreased comparably in both the PRN and monthly cohorts (p=0.33). For all patients, average mean sensitivity significantly improved by 1.7 ± 0.5 dB (p<0.05) and N1-P1 response density significantly decreased by 0.52 ± 0.21 nV/deg 2 (p<0.05).
Conclusion
Both PRN and monthly treatment of exudative AMD with ranibizumab improve visual function as assessed by BCVA and MP. Macular thickening also improved as demonstrated by HR-OCT findings. However, the decreased retinal function noted by mfERG suggests that some loss of retinal function still occurs despite effective treatment. These measures of visual function may be useful in assessing retinal health and response to treatment in future clinical trials.",2020,Macular function assessed with mfERG decreased comparably in both the PRN and monthly cohorts (p=0.33).,"['Neovascular', '43 patients in the PRN cohort and 33 patients in the monthly cohort', 'patients with exudative AMD over 12 months', 'exudative macular degeneration (AMD']","['Ranibizumab', 'pro re nata (PRN) ranibizumab injections', 'ranibizumab']","['N1-P1 response density', 'Macular thickening', 'visual function', 'Best-corrected visual acuity (BCVA', 'Mean BCVA', 'Macular function', 'Macular function assessed with mfERG', 'average mean sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0311438', 'cui_str': 'Exudative'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C2237660', 'cui_str': 'Wet Macular Degeneration'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}]","[{'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1627756', 'cui_str': 'Multifocal electroretinography'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0368123,Macular function assessed with mfERG decreased comparably in both the PRN and monthly cohorts (p=0.33).,"[{'ForeName': 'Masumi G', 'Initials': 'MG', 'LastName': 'Asahi', 'Affiliation': 'Clinical Research Department, Retina Macula Institute, Torrance, CA, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Wallsh', 'Affiliation': 'Clinical Research Department, Retina Macula Institute, Torrance, CA, USA.'}, {'ForeName': 'Spencer M', 'Initials': 'SM', 'LastName': 'Onishi', 'Affiliation': 'Clinical Research Department, Retina Macula Institute, Torrance, CA, USA.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Kuroyama', 'Affiliation': 'Clinical Research Department, Retina Macula Institute, Torrance, CA, USA.'}, {'ForeName': 'Ron P', 'Initials': 'RP', 'LastName': 'Gallemore', 'Affiliation': 'Clinical Research Department, Retina Macula Institute, Torrance, CA, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S270243']
2239,33154681,Sex Differences in Stress Reactivity to the Trier Social Stress Test in Virtual Reality.,"Objective
The aims of the present study were twofold: 1) to examine the effects of a virtual reality version of Trier Social Stress Test (TSST-VR) using a placebo as the control condition; 2) to delineate sex differences in psychophysiological responses following the TSST-VR.
Methods
Healthy young male (n = 30) and female (n = 30) undergraduates were randomly assigned to a psychosocial stress protocol condition or to a non-stressful control condition (placebo) also under virtual reality environment (VR). Electrodermal activity (EDA), heart rate (HR) and heart rate variability (HRV) were measured throughout the condition. The visual analog scale (VAS) was used to assess the perceived stress before and after the condition. We also included subjective scales of emotional states and coping.
Results
Different ANOVAs showed that after VR, the stress group reported higher scores on VAS than the non-stress group. Before VR, compared with females, the males showed stronger EDA and higher HRV. Under VR, the males had lower HR. After VR, the males' HR was still lower than females', but their HRV was higher than females'. Finally, the correlation between subjective and objective reactivity demonstrated that HRV during the experiment was negatively correlated to depression and negative affect. The HRV after VR was negatively correlated to the positive coping but was positively correlated to the depression.
Conclusion
These findings suggest that the TSST-VR could be used as an available tool for testing sex differences to psychosocial stress induction in experimental settings. Compared with females, males were more sensitive to stress. The scores on depression, negative affect and positive coping before the stress induction may be able to predict the arousal of the sympathetic nervous system across the stress situations.",2020,"Different ANOVAs showed that after VR, the stress group reported higher scores on VAS than the non-stress group.",['Healthy young male (n = 30) and female (n = 30) undergraduates'],"['psychosocial stress protocol condition or to a non-stressful control condition (placebo) also under virtual reality environment (VR', 'placebo', 'virtual reality version of Trier Social Stress Test (TSST-VR', 'TSST-VR']","['Electrodermal activity (EDA), heart rate (HR) and heart rate variability (HRV', 'visual analog scale (VAS', 'subjective scales of emotional states and coping', 'VAS', 'stronger EDA and higher HRV']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1293902', 'cui_str': 'Stress protocol'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0205250', 'cui_str': 'High'}]",30.0,0.0143011,"Different ANOVAs showed that after VR, the stress group reported higher scores on VAS than the non-stress group.","[{'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""College of Education and Technology, Zhejiang University of Technology, Hangzhou, People's Republic of China.""}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Mental Health Education Center, Xidian University, Xi'an, Shaanxi, People's Republic of China.""}]",Psychology research and behavior management,['10.2147/PRBM.S268039']
2240,33157498,A double blind randomized controlled trial using copper impregnated maternity sanitary towels to reduce perineal wound infection.,"OBJECTIVE
To investigate the effect of copper impregnated sanitary towels on the infection rate following vaginal delivery (VD).
DESIGN
Single center double blind randomized controlled trial.
PARTICIPANTS
Women aged 18 or over who had a sutured second-degree tear or episiotomy following VD.
INTERVENTIONS
All women were randomized to receive either a copper-oxide impregnated sanitary towel (study group) or a non-copper sanitary towel (control group).
MAIN OUTCOME MEASURES
The primary study outcome was the incidence of wound infection within a 30-day period from VD, assessed via telephone questionnaire. Secondary outcomes were length of hospital stay and risk factors of infection.
RESULTS
450 women were enrolled in the study of whom 225 were randomized to the copper impregnated sanitary towel (study group) and 225 to the non-copper sanitary towel (control group) group. Follow-up rate was 98.2%. A total of 102 women (23.1%) developed an infection within 30 days following VD, 19 in the study group (8.6%) and 83 (37.4%) in the control group (P = <0.001, absolute risk reduction (ARR) of 28.8%). The incidence of superficial/deep and organ/space infections was significantly lower in the study group (7.7% vs. 30.2%, P = <0.001 and 4.6% vs. 31.5%, P = <0.001 respectively) with an ARR of 22.5% and 27.0% respectively. Multivariable analysis reported Asian ethnicity and prolonged rupture of membranes as significant risk factors; for the development of infection (OR 1.91, P = 0.03 and OR = 1.97, P = 0.04 respectively).
CONCLUSIONS
This is the first study to demonstrate a significant reduction in infection rate following VD with the use of copper impregnated sanitary towels.",2020,"The incidence of superficial/deep and organ/space infections was significantly lower in the study group (7.7% vs. 30.2%, P = ","['Women aged 18 or over who had a sutured second-degree tear or episiotomy following VD', '450 women were enrolled in the study of whom 225 were randomized to the copper impregnated sanitary towel (study group) and 225 to the non-copper sanitary towel (control group) group']","['copper impregnated maternity sanitary towels', 'copper-oxide impregnated sanitary towel (study group) or a non-copper sanitary towel (control group']","['incidence of superficial/deep and organ/space infections', 'length of hospital stay and risk factors of infection', 'infection rate', 'perineal wound infection', 'incidence of wound infection within a 30-day period from VD, assessed via telephone questionnaire']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0443298', 'cui_str': 'Second degree'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0336616', 'cui_str': 'Towel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0336616', 'cui_str': 'Towel'}, {'cui': 'C0056598', 'cui_str': 'Cupric oxide'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",450.0,0.323081,"The incidence of superficial/deep and organ/space infections was significantly lower in the study group (7.7% vs. 30.2%, P = ","[{'ForeName': 'Linda Petra', 'Initials': 'LP', 'LastName': 'Arendsen', 'Affiliation': 'Obstetrics and Gynaecology Department, Croydon University Hospital, 530 London Road, CR7 7YE, United Kingdom.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Thakar', 'Affiliation': 'Obstetrics and Gynaecology Department, Croydon University Hospital, 530 London Road, CR7 7YE, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy Ltd, 40 Longwood Lane, Amersham, Bucks, HP7 9EN, United Kingdom.'}, {'ForeName': 'Abdul Hameed', 'Initials': 'AH', 'LastName': 'Sultan', 'Affiliation': ""Obstetrics and Gynaecology Department, Croydon University Hospital, 530 London Road, CR7 7YE, United Kingdom; Honorary Reader, St George's University of London, Cranmer Terrace, SW17 0RE, United Kingdom. Electronic address: abdulsultan@nhs.net.""}]",Midwifery,['10.1016/j.midw.2020.102858']
2241,33157912,Impact of rational emotive behavioral therapy on personal value system of students with visual impairment: A group randomized control study.,"BACKGROUND
Visually impaired students have been reported to struggle with value system and rash decision making process. This study examined the impact of rational emotive behavioral therapy (REBT) in reducing negative personal value system of visually impaired people.
METHOD
A group-randomized trial design was adopted using 56 students with visual impairment. The participants received a value-based rational emotive behavior progamme and were assessed at 3 points using PVS and ABS-2-AV.
RESULTS
The result of analysis of covariance showed that there was no significant difference between the treatment and control groups in initial personal value in Nigerian as measured by PVS. At the post-treatment the effect of V-REBP was significant in personal value and follow-up assessment respectively in favour of treatment group.
CONCLUSION
We concluded that there is significant impact of rational emotive behavioral therapy on reduction of negative personal value system of students with visual impairment.",2020,The result of analysis of covariance showed that there was no significant difference between the treatment and control groups in initial personal value in Nigerian as measured by PVS.,"['students with visual impairment', '56 students with visual impairment', 'visually impaired people']","['rational emotive behavioral therapy (REBT', 'rational emotive behavioral therapy']",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]",[],,0.0269281,The result of analysis of covariance showed that there was no significant difference between the treatment and control groups in initial personal value in Nigerian as measured by PVS.,"[{'ForeName': 'Godwin C', 'Initials': 'GC', 'LastName': 'Abiogu', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Moses Onyemaechi', 'Initials': 'MO', 'LastName': 'Ede', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Fidelis E', 'Initials': 'FE', 'LastName': 'Amaeze', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Ogechi', 'Initials': 'O', 'LastName': 'Nnamani', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Agah', 'Affiliation': 'Department of Science Education University of Nigeria, Nsukka.'}, {'ForeName': 'Clifford E', 'Initials': 'CE', 'LastName': 'Ogheneakoke', 'Affiliation': 'Department of Social Sciences Education, Delta State University Abraka Delta State.'}, {'ForeName': 'Felix O', 'Initials': 'FO', 'LastName': 'Ugwuozor', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Ngozi', 'Initials': 'N', 'LastName': 'Obiyo', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Chukwuemeka', 'Initials': 'C', 'LastName': 'Ezurike', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Nneka', 'Initials': 'N', 'LastName': 'Nwosu', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Obageli C', 'Initials': 'OC', 'LastName': 'Onyeanusi', 'Affiliation': 'Department of Social Sciences Education, University of Nigeria, Nsukka.'}, {'ForeName': 'Maduaka L', 'Initials': 'ML', 'LastName': 'Nweke', 'Affiliation': 'Department of Philosophy, Faculty of Social Sciences, University of Nigeria, Nsukka.'}, {'ForeName': 'Chijioke V', 'Initials': 'CV', 'LastName': 'Amoke', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Asogwa', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Emmanuel I', 'Initials': 'EI', 'LastName': 'Obeagu', 'Affiliation': 'Department of Medical Laboratory Science, Imo State University, Owerri, Imo State, Nigeria.'}, {'ForeName': 'Kelechi R', 'Initials': 'KR', 'LastName': 'Ede', 'Affiliation': 'Department of Agricultural Science Education, University of Nigeria, Nsukka, Nigeria.'}]",Medicine,['10.1097/MD.0000000000022333']
2242,33157927,Rapid rehabilitation nursing improves clinical outcomes in postoperative patients with colorectal carcinoma: A protocol for randomized controlled trial.,"BACKGROUND
Colorectal carcinoma has a high incidence rate and the high mortality rate has always been an important global health challenge. Surgical treatment is widely performed in patients with colorectal carcinoma. Fast track surgery (FTS) applies evidence-based medical concept to optimize the management during the operation, so as to reduce the psychological and physical trauma stress of surgical patients and make them recover rapidly. We perform this protocol for randomized controlled study to evaluate the efficacy of a rapid rehabilitation care in colorectal carcinoma surgery.
METHODS
It is a single-center randomized controlled study to be conducted from January 2021 to December 2021. It was authorized via the Ethics Committee of the Huzhou Central Hospital (20191127-01). Eighty participants who undergo colorectal carcinoma surgery will be included in this research. Patients are randomly assigned to control group (standard management group, including 40 samples) and study group (the FTS group, including 40 samples). The main results are times of postoperative exhaust, first defecation, ambulation, first eating, and postoperative hospital stay. Secondary outcomes are incidence of nausea and emesis, wound infection, urinary tract infection, lung infection, deep vein thrombosis, and rehospitalization rate among the 2 groups. All analyses are conducted using the SPSS for Windows Release 15.0.
RESULTS
Figure 1 shows the clinical results between groups.
CONCLUSION
The research can offer a reliable basis for the effectiveness of a rapid recovery nursing program in patients with colorectal carcinoma.
TRIAL REGISTRATION
This study protocol was registered in Research Registry (researchregistry6038).",2020,"The main results are times of postoperative exhaust, first defecation, ambulation, first eating, and postoperative hospital stay.","['patients with colorectal carcinoma', 'January 2021 to December 2021', 'Eighty participants who undergo colorectal carcinoma surgery', 'postoperative patients with colorectal carcinoma', 'colorectal carcinoma surgery']","['control group (standard management group, including 40 samples) and study group (the FTS', 'Fast track surgery (FTS', 'Rapid rehabilitation nursing', 'rapid rehabilitation care']","['times of postoperative exhaust, first defecation, ambulation, first eating, and postoperative hospital stay', 'incidence of nausea and emesis, wound infection, urinary tract infection, lung infection, deep vein thrombosis, and rehospitalization rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0376427', 'cui_str': 'Nursing, Rehabilitation'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}]",80.0,0.121116,"The main results are times of postoperative exhaust, first defecation, ambulation, first eating, and postoperative hospital stay.","[{'ForeName': 'Genying', 'Initials': 'G', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastrointestinal Surgery, Huzhou Central Hospital (Affiliated Central Hospital of HuZhou University), Zhejiang, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022857']
2243,33157937,Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol.,"INTRODUCTION
Treatment-resistant depression (TRD) has a high prevalence and can be exacerbated by poor physical health and economic hardships, which have become common stressors during the current COVID-19 pandemic. The therapeutic approaches used to treat these patients are not always available, may be not be accepted by some patients, and often require face-to-face interactions.
OBJECTIVE
The main aim of this study will be to evaluate the effectiveness of an Internet-based adjuvant lifestyle-based intervention for patients with TRD.
METHODS
This will be a parallel, randomized, and controlled clinical trial. A total of 180 patients with TRD will be randomly allocated (1:1:1) to 1 of 3 groups: treatment prescribed by the mental health team and written suggestions for lifestyle changes (placebo control group); treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week mindfulness-based cognitive therapy program (active control group); or treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week lifestyle change promotion program (intervention group). We will perform this study during the COVID-19 pandemic, and will administer interventions by teletherapy, and contact participants by telephone calls, text messages, and/or teleconferences. We will collect patient data using questionnaires administered at baseline, immediately after the intervention, and after 6 and 12 months. The primary outcome will be score on the Beck Depression Inventory-II. The secondary outcomes will be score on the Clinical Global Impressions Scale (used to quantify and track patient progress and treatment response over time) and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire.
DISCUSSION
Patients with TRD are especially vulnerable when face-to-face psychotherapy is unavailable. The main strength of the proposed study is the novelty of the intervention to be used as an adjuvant therapy. Our results may provide guidance for treatment of patients with TRD in future situations that require lockdown measures.
CLINICALTRIALS REGISTRATION NUMBER
NCT04428099.",2020,"The secondary outcomes will be score on the Clinical Global Impressions Scale (used to quantify and track patient progress and treatment response over time) and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire.
","['patients with TRD', '180 patients with TRD', 'treatment-resistant major depression during COVID 19 pandemic']","['Internet-based adjuvant lifestyle-based intervention', 'mental health team and written suggestions for lifestyle changes (placebo control group); treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week mindfulness-based cognitive therapy program (active control group); or treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week lifestyle change promotion program (intervention group', 'healthy lifestyle promotion program']","['score on the Beck Depression Inventory-II', 'Clinical Global Impressions Scale (used to quantify and track patient progress and treatment response over time) and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",180.0,0.073809,"The secondary outcomes will be score on the Clinical Global Impressions Scale (used to quantify and track patient progress and treatment response over time) and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire.
","[{'ForeName': 'Capilla', 'Initials': 'C', 'LastName': 'Navarro', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Aina M', 'Initials': 'AM', 'LastName': 'Yáñez', 'Affiliation': 'Department of Nursing and Physiotherapy and Research Group on Global Health and Human Development.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Seguí', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gazquez', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'Marino', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Ibarra', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Serrano-Ripoll', 'Affiliation': 'Primary Care Research Unit of Majorca, Balearic Islands Health Services and Department of Psychology, University of the Balearic Islands, Palma.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Gomez-Juanes', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Bennasar-Veny', 'Affiliation': 'Department of Nursing and Physiotherapy and Research Group on Global Health and Human Development.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Salva', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Bárbara', 'Initials': 'B', 'LastName': 'Oliván', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza and Preventive Activities and Health Promotion Network, REDIAPP (G06/170), Zaragoza, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Garcia-Toro', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}]",Medicine,['10.1097/MD.0000000000022958']
2244,33157939,"The efficacy and safety of Clostridium butyricum and Bacillus coagulans in Helicobacter pylori eradication treatment: An open-label, single-arm pilot study.","BACKGROUND
Helicobacter pylori (H pylori) infection plays a critical role in gastritis-associated diseases, gastroduodenal ulcers, and even gastric cancer. Studies have shown that probiotics may exhibit antagonistic activity against H pylori.
METHODS
This study aimed to assess the efficacy and safety of monotherapy with Clostridium butyricum (C butyricum) and Bacillus coagulans (B coagulans) for H pylori treatment. Our research was an open-label, single-arm pilot study of H pylori eradication. Subjects diagnosed with H pylori infection as outpatients at Xijing Hospital were randomized (1:1:1) to receive 8 weeks of therapy with C butyricum (group A), B coagulans (group B), or C butyricum plus B coagulans (group C). H pylori status was assessed 1 to 2 weeks after treatment. The H pylori eradication rate according to intention-to-treat and per-protocol analyses was the primary outcome of study, and the delta over baseline score, adverse events, and compliance were the secondary outcomes. This study was registered at ClinicalTrials.gov (NCT03857425).
RESULTS
A total of 150 subjects were consecutively enrolled from February 2019 to August 2019. The ITT analysis demonstrated that the 3 groups achieved similar eradication rates (18%, 20%, and 26%, respectively, P = .597). The PP analysis yielded a similar result (24.3%, 26.3%, and 32.5%, respectively, P = .703). None of the subjects reported adverse events during treatment. The 3 groups had comparable compliance rates (74% vs 76% vs 80%, P > .05).
CONCLUSION
C butyricum and B coagulans may effectively inhibit H pylori to some extent, with rare adverse events, and thus may reduce the burden of antibiotic resistance.",2020,"The 3 groups had comparable compliance rates (74% vs 76% vs 80%, P > .05).
","['Subjects diagnosed with H pylori infection as outpatients at Xijing Hospital', 'A total of 150 subjects were consecutively enrolled from February 2019 to August 2019']","['Clostridium butyricum and Bacillus coagulans', 'therapy with C butyricum (group A), B coagulans (group B), or C butyricum plus B coagulans', 'monotherapy with Clostridium butyricum (C butyricum) and Bacillus coagulans (B coagulans']","['H pylori eradication rate', 'eradication rates', 'efficacy and safety', 'adverse events', 'compliance rates', 'H pylori status']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0315063', 'cui_str': 'Clostridium butyricum'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0314931', 'cui_str': 'Bacteroides coagulans'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",150.0,0.0617105,"The 3 groups had comparable compliance rates (74% vs 76% vs 80%, P > .05).
","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases.'}, {'ForeName': 'Jingzhi', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Xijing Hospital, Air Force Military Medical University.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Xi'an Medical University.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': ""Xi'an Medical University.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""Xi'an Medical University.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Luyao', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases.'}, {'ForeName': 'Yongquan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases.'}]",Medicine,['10.1097/MD.0000000000022976']
2245,33157963,Clinical observation of the combined use of propofol and etomidate in painless gastroscopy.,"OBJECTIVE
This study is aims to compare the anesthetic safety of propofol combined with etomidate for painless gastroscopy.
METHODS
Three hundred patients undergoing painless gastroscopy were randomly assigned to P, PE1, and PE2 groups. Patients were anesthetized with propofol (P group) or propofol combined with etomidate (volume ratio 1: 1, PE1 group; volume ratio 2: 1, PE2 group). The hemodynamics and adverse reactions were observed. The sleep quality satisfaction and nature of dreams were recorded.
RESULTS
Compared with pre-anesthesia, the mean arterial pressure and heart rate of the 3 groups were significantly slower during the examination and at the end of the examination. PE1 group had a higher incidence of muscle spasm, body moving, choking, and deglutition. The incidence of hypoxemia and injection pain was higher in P group. P and PE2 group had higher sleep quality satisfaction and dream incidence after awaking. However, there was no difference in the nature of dreams among 3 groups.
CONCLUSION
Our data indicate that the combination of 10 ml 1.0% propofol and 5 ml 0.2% etomidate for painless gastroscopy reduces adverse reactions while not affecting the patients respiratory function. Moreover, it is safe and effective, which is worthy of clinical application and promotion.",2020,"Compared with pre-anesthesia, the mean arterial pressure and heart rate of the 3 groups were significantly slower during the examination and at the end of the examination.","['Three hundred patients undergoing painless gastroscopy', 'painless gastroscopy']","['propofol and etomidate', 'propofol', 'PE1', 'propofol combined with etomidate']","['muscle spasm, body moving, choking, and deglutition', 'incidence of hypoxemia and injection pain', 'sleep quality satisfaction', 'adverse reactions', 'hemodynamics and adverse reactions', 'anesthetic safety', 'sleep quality satisfaction and nature of dreams', 'nature of dreams', 'mean arterial pressure and heart rate']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0037763', 'cui_str': 'Spasm'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0008301', 'cui_str': 'Choking'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0013117', 'cui_str': 'Dream'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",300.0,0.0328939,"Compared with pre-anesthesia, the mean arterial pressure and heart rate of the 3 groups were significantly slower during the examination and at the end of the examination.","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Division of Life Sciences and Medicine, University of Science and Technology of China, 1st Swan lake road, Shushan District, Hefei, Anhui Province, China.'}, {'ForeName': 'Xibei', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Bingqing', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Wanhong', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Kang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000023061']
2246,33157974,The efficacy of gelatin sponge combined with moist wound-healing nursing intervention for the treatment of pressure ulcers: A randomized controlled trial protocol.,"OBJECTIVE
The objective of this current research is to investigate the effectiveness of the nursing intervention of combination gelatin sponge and moist wound healing in treating the pressure ulcers (PUs).
METHODS
This is a randomized controlled trial to be carried out from January 2021 to May 2021. This trial is implemented in accordance with the SPIRIT Checklist for the randomized researches and was granted through the Ethics Committee of 5th Medical Center of Chinese PLA General Hospital (No. 0624876). This study includes 80 PU participants. The patients meet the following criteria will be included. All participants meet the diagnostic criteria recommended via the National Pressure Ulcer Advisory Panel Society: complete skin defect, no bones, tendons and muscles exposure, no subcutaneous tunnel or scale; the patients selected are between 40 and 60 years old. The patients with the following criteria will be excluded: receiving other treatments that may influence the healing, for instance, radiation therapy and corticosteroids; patients with the complications of infection, malignant tumors, as well as peripheral vascular disease; and patients with serious diseases, containing kidney, cardiac, and liver diseases. The patients are randomly divided into 2 groups, the control group and study group, with 40 members in each group. In control group, the patients are given the routine nursing care. And in study group, the patients are given the nursing of gelatin sponge combined with moist wound-healing. After 28 days, the state of the patients healing is observed closely, containing the dressing change frequency, curative effects, and the end-point efficiency. On the basis of the Pressure Ulcer Healing Scale developed by the American pressure sore expert group, the quantitative scoring can be implemented, and therapeutic effects are assessed.
RESULTS
The variables of clinical result among the groups are illustrated in the Table.
CONCLUSION
The nursing intervention of gelatin sponge combined with the moist wound- healing may evidently increase the healing efficiency of PU.
TRIAL REGISTRATION NUMBER
researchregistry 6091.",2020,"After 28 days, the state of the patients healing is observed closely, containing the dressing change frequency, curative effects, and the end-point efficiency.","['80 PU participants', 'pressure ulcers', 'All participants meet the diagnostic criteria recommended via the National Pressure Ulcer Advisory Panel Society: complete skin defect, no bones, tendons and muscles exposure, no subcutaneous tunnel or scale; the patients selected are between 40 and 60 years old', 'January 2021 to May 2021', 'patients with the following criteria will be excluded: receiving other treatments that may influence the healing, for instance, radiation therapy and corticosteroids; patients with the complications of infection, malignant tumors, as well as peripheral vascular disease; and patients with serious diseases, containing kidney, cardiac, and liver diseases']","['gelatin sponge combined with moist wound-healing nursing intervention', 'combination gelatin sponge and moist wound healing', 'gelatin sponge combined with moist wound-healing']","['Pressure Ulcer Healing Scale', 'healing efficiency of PU']","[{'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}]","[{'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0032699', 'cui_str': 'Phylum Porifera'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.029843,"After 28 days, the state of the patients healing is observed closely, containing the dressing change frequency, curative effects, and the end-point efficiency.","[{'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Nursing.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Nursing.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Liver Cirrhosis Diagnosis and Treatment Center.'}, {'ForeName': 'Yonggang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Intensive Care Center, 5th Medical Center of Chinese PLA General Hospital, Beijing, PR China.'}]",Medicine,['10.1097/MD.0000000000023079']
2247,33157981,"Evaluation of the efficacy of a commercially available regimen vs brushing alone on established plaque and gingivitis on adolescents: Study protocol for a randomized, controlled, blind clinical trial.","BACKGROUND
Dental biofilm accumulation and poor personal oral hygiene are known major risk factors for gingivitis and halitosis. However, it is not clear how studies compare the effectiveness of hygiene regimens, associated with outcomes centered on patients.
METHODS
A randomized, blind, controlled clinical trial involving 58 participants aged from 12 to 17 years, who search the Department of Pediatric Dentistry of Universidade Metropolitana de Santos, will be conducted. Immediately, the volunteers will be inserted into Group 1 (commercially available hygiene regimen) or Group 2 (tooth brushing alone). In Group 1, participants will receive Colgate Total 12 toothpastes, Plax mouthwashes and Colgate Ultrasoft toothbrushes, while Group 2 will use Colgate Cavity Protection toothpastes and Colgate Ultrasoft toothbrushes. The interventions will be conducted in the periods of 1, 3, and 6 months after the baseline, when the evaluations will also be performed. Biofilm and halitosis indexes will be evaluated. Data regarding discomfort, satisfaction and the socioeconomic/individual characteristics will also be computed.
DISCUSSION
Although toothbrushing has shown positive effects in decreasing biofilm and in gingival health, there is no comparison in the literature of different brushing regimens with halitosis measurement in adolescents. In addition, the effectiveness of these protocols would be confirmed from the acceptability of the volunteers.",2020,"Immediately, the volunteers will be inserted into Group 1 (commercially available hygiene regimen) or Group 2 (tooth brushing alone).","['adolescents', 'established plaque and gingivitis on adolescents', '58 participants aged from 12 to 17 years, who search the Department of Pediatric Dentistry of Universidade Metropolitana de Santos, will be conducted']","['Colgate Total 12 toothpastes, Plax mouthwashes and Colgate Ultrasoft toothbrushes, while Group 2 will use Colgate Cavity Protection toothpastes and Colgate Ultrasoft toothbrushes']",['Biofilm and halitosis indexes'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030763', 'cui_str': 'Pediatric dentistry'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C2974025', 'cui_str': 'Colgate Total Fresh Stripe Toothpaste'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0137288', 'cui_str': 'Plax'}, {'cui': 'C2345900', 'cui_str': 'Colgate'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0018520', 'cui_str': 'Breath smells unpleasant'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",58.0,0.0970697,"Immediately, the volunteers will be inserted into Group 1 (commercially available hygiene regimen) or Group 2 (tooth brushing alone).","[{'ForeName': 'Caroline Moraes', 'Initials': 'CM', 'LastName': 'Moriyama', 'Affiliation': 'Dentistry College, Universidade Metropolitana de Santos - UNIMES.'}, {'ForeName': 'Elaine Marcílio', 'Initials': 'EM', 'LastName': 'Santos', 'Affiliation': 'Dentistry College, Universidade Metropolitana de Santos - UNIMES.'}, {'ForeName': 'Marcela Leticia Leal', 'Initials': 'MLL', 'LastName': 'Gonçalves', 'Affiliation': 'Dentistry College, Universidade Metropolitana de Santos - UNIMES.'}, {'ForeName': 'Carlos Alberto', 'Initials': 'CA', 'LastName': 'Tubel', 'Affiliation': 'Dentistry College, Universidade Metropolitana de Santos - UNIMES.'}, {'ForeName': 'Matheus Pereira da', 'Initials': 'MPD', 'LastName': 'Silva', 'Affiliation': 'Dentistry College Students, Universidade Metropolitana de Santos - UNIMES, Santos.'}, {'ForeName': 'Victor Augusto Whately', 'Initials': 'VAW', 'LastName': 'Nascimento', 'Affiliation': 'Dentistry College Students, Universidade Metropolitana de Santos - UNIMES, Santos.'}, {'ForeName': 'Victor Perez', 'Initials': 'VP', 'LastName': 'Teixeira', 'Affiliation': 'Dentistry College, Universidade Metropolitana de Santos - UNIMES.'}, {'ForeName': 'Ana Paula Taboada', 'Initials': 'APT', 'LastName': 'Sobral', 'Affiliation': 'Dentistry College, Universidade Metropolitana de Santos - UNIMES.'}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Postgraduation Program in Biophotonics Applied to Health Sciences, Nove de Julho University - UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': 'Postgraduation Program in Biophotonics Applied to Health Sciences, Nove de Julho University - UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Eloisa Andrade de', 'Initials': 'EA', 'LastName': 'Paula', 'Affiliation': 'Dentistry College, Universidade Metropolitana de Santos - UNIMES.'}, {'ForeName': 'Gabriela Traldi Zaffalon de Almeida', 'Initials': 'GTZA', 'LastName': 'Magalhães', 'Affiliation': 'Dentistry College, Universidade Metropolitana de Santos - UNIMES.'}, {'ForeName': 'José Cassio de Almeida', 'Initials': 'JCA', 'LastName': 'Magalhães', 'Affiliation': 'Dentistry College, Universidade Metropolitana de Santos - UNIMES.'}, {'ForeName': 'Alessandro Melo', 'Initials': 'AM', 'LastName': 'Deana', 'Affiliation': 'Postgraduation Program in Biophotonics Applied to Health Sciences, Nove de Julho University - UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Kylze Ikegami', 'Initials': 'KI', 'LastName': 'Sakiyama', 'Affiliation': 'Dentistry College, Universidade Metropolitana de Santos - UNIMES.'}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': 'Dentistry College, Universidade Metropolitana de Santos - UNIMES.'}]",Medicine,['10.1097/MD.0000000000023092']
2248,33158230,A Parental Smoking Cessation Intervention in the Pediatric Emergency Setting: A Randomized Trial.,"We examined the efficacy of a pediatric emergency visit-based screening, brief intervention, and referral to treatment (SBIRT) condition compared to a control condition (Healthy Habits Control, HHC) to help parental smokers quit smoking. We enrolled 750 parental smokers who presented to the pediatric emergency setting with their child into a two-group randomized controlled clinical trial. SBIRT participants received brief cessation coaching, quitting resources, and up to 12-weeks of nicotine replacement therapy (NRT). HHC participants received healthy lifestyle coaching and resources. The primary outcome was point-prevalence tobacco abstinence at six weeks (T1) and six months (T2). The mean (SD) age of parents was 31.8 (7.7) years, and 86.8% were female, 52.7% were Black, and 64.6% had an income of ≤$15,000. Overall abstinence rates were not statistically significant with 4.2% in both groups at T1 and 12.9% and 8.3% in the SBIRT and HHC groups, respectively, at T2. There were statistically significant differences in SBIRT versus HHC participants on the median (IQR) reduction of daily cigarettes smoked at T1 from baseline (-2 [-5, 0] versus 0 [-4, 0], p = 0.0008),at T2 from baseline (-4 [-9, -1] vs. -2 [-5, 0], p = 0.0006), and on the mean (SD) number of quit attempts at T2 from baseline (1.25 (6.5) vs. 0.02 (4.71), p = 0.02). Self-reported quitting rates were higher in SBIRT parents who received NRT (83.3% vs. 50.9%, p = 0.04). The novel use of the pediatric emergency visit to conduct cessation interventions helped parents quit smoking. The near equivalent abstinence rates in both the SBIRT and HHC groups may be due to underlying parental concern about their child's health. Cessation interventions in this setting may result in adult and pediatric public health benefits.",2020,"There were statistically significant differences in SBIRT versus HHC participants on the median (IQR) reduction of daily cigarettes smoked at T1 from baseline (-2 [-5, 0] versus 0","['The mean (SD) age of parents was 31.8 (7.7) years, and 86.8% were female, 52.7% were Black, and 64.6% had an income of ≤$15,000', 'Pediatric Emergency Setting', '750 parental smokers who presented to the pediatric emergency setting with their child into a two-group randomized controlled clinical trial']","['healthy lifestyle coaching and resources', 'Parental Smoking Cessation Intervention', 'pediatric emergency visit-based screening, brief intervention, and referral to treatment (SBIRT) condition compared to a control condition (Healthy Habits Control, HHC', 'nicotine replacement therapy (NRT']","['Overall abstinence rates', 'mean (SD) number of quit attempts', 'median (IQR) reduction of daily cigarettes smoked', 'Self-reported quitting rates', 'point-prevalence tobacco abstinence at six weeks (T1) and six months (T2']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0557110', 'cui_str': 'Age of parents'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0342637', 'cui_str': 'Hypocalciuric hypercalcemia, familial, type 1'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]",750.0,0.090137,"There were statistically significant differences in SBIRT versus HHC participants on the median (IQR) reduction of daily cigarettes smoked at T1 from baseline (-2 [-5, 0] versus 0","[{'ForeName': 'E Melinda', 'Initials': 'EM', 'LastName': 'Mahabee-Gittens', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229-3026, USA.""}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Ammerman', 'Affiliation': 'College of Medicine, University of Cincinnati, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Khoury', 'Affiliation': 'College of Medicine, University of Cincinnati, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Meredith E', 'Initials': 'ME', 'LastName': 'Tabangin', 'Affiliation': 'College of Medicine, University of Cincinnati, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'College of Medicine, University of Cincinnati, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Ashley L', 'Initials': 'AL', 'LastName': 'Merianos', 'Affiliation': 'School of Human Services, University of Cincinnati, Cincinnati, OH 45221, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Stone', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229-3026, USA.""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Gordon', 'Affiliation': 'College of Nursing, University of Arizona, Tucson, AZ 85721, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17218151']
2249,33158239,"A Health Guidance App to Improve Motivation, Adherence to Lifestyle Changes and Indicators of Metabolic Disturbances among Japanese Civil Servants.","We investigated whether an Information and Communication Technology (ICT) application (app) motivated to increase adherence to lifestyle changes, and to improve indicators of metabolic disturbances among Japanese civil servants. A non-randomized, open-label, parallel-group study was conducted with 102 participants aged 20-65 years undergoing a health check during 2016-2017, having overweight and/or elevated glucose concentration. Among them, 63 participants chose Specific Health Guidance (SHG) and ongoing support incorporating the use of an app (ICT group) and 39 individuals chose only SHG (control group). Fifty from the ICT group and 38 from the control group completed the study. After completing the 6-month program, the control group showed a significant decrease in body mass index ( p = 0.008), male waist circumference ( p < 0.001), systolic blood pressure (BP) ( p = 0.005), diastolic BP ( p < 0.001), and glycated hemoglobin (HbA1c) ( p < 0.001), and increase in high-density lipoprotein (HDL) cholesterol ( p = 0.008). However, the ICT group showed a significant decrease in male waist circumference ( p < 0.001), diastolic BP ( p = 0.003), and HbA1c ( p < 0.001), and increase in HDL cholesterol ( p = 0.032). The magnitude of change for most indicators tended to be highest for ICT participants (used the app ≥5 times/month). Both groups reported raised awareness on BP and weight. The app use program did not have a major impact after the observation period. Proper action requires frequent use of the app to enhance best results.",2020,"However, the ICT group showed a significant decrease in male waist circumference ( p < 0.001), diastolic BP ( p = 0.003), and HbA1c ( p < 0.001), and increase in HDL cholesterol ( p = 0.032).","['Japanese Civil Servants', '102 participants aged 20-65 years undergoing a health check during 2016-2017, having overweight and/or elevated glucose concentration', 'Japanese civil servants', '63 participants chose Specific Health Guidance (SHG) and ongoing support incorporating the use of an app (ICT group) and 39 individuals chose only SHG (control group']","['Information and Communication Technology (ICT) application (app', 'ICT']","['body mass index', 'male waist circumference', 'systolic blood pressure (BP', 'HDL cholesterol', 'BP and weight', 'glycated hemoglobin (HbA1c', 'high-density lipoprotein (HDL) cholesterol', 'diastolic BP']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0401892', 'cui_str': 'Civil servant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",102.0,0.0248838,"However, the ICT group showed a significant decrease in male waist circumference ( p < 0.001), diastolic BP ( p = 0.003), and HbA1c ( p < 0.001), and increase in HDL cholesterol ( p = 0.032).","[{'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Takeyama', 'Affiliation': 'Division of Nursing Science, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8553, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Moriyama', 'Affiliation': 'Division of Nursing Science, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8553, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Kazawa', 'Affiliation': 'Division of Nursing Science, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8553, Japan.'}, {'ForeName': 'Malinda', 'Initials': 'M', 'LastName': 'Steenkamp', 'Affiliation': 'Division of Nursing Science, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8553, Japan.'}, {'ForeName': 'Md Moshiur', 'Initials': 'MM', 'LastName': 'Rahman', 'Affiliation': 'Division of Nursing Science, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima 734-8553, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph17218147']
2250,33158245,Comparison of Dose Distribution in Regional Lymph Nodes in Whole-Breast Radiotherapy vs. Whole-Breast Plus Regional Lymph Node Irradiation: An In Silico Planning Study in Participating Institutions of the Phase III Randomized Trial (KROG 1701).,"The purpose of the current in silico planning study is to compare radiation doses of whole-breast irradiation (WBI) and whole-breast plus regional lymph node irradiation (WBI+RNI) administered to the regional lymph nodes (RLN) in pN1 breast cancer. Twenty-four participating institutions were asked to create plans of WBI and WBI+RNI for two dummy cases. To compare target coverage between the participants, an isodose line equal to 90% of the prescribed dose was converted to an isodose contour (contour 90% iso ) . The relative nodal dose (RND) was obtained using the ratio of RLN dose to the target dose. The Fleiss's kappa values which represent inter-observer agreement of contour 90% iso were over 0.68. For RNI, 6 institutions included axillary lymph node (ALN), supraclavicular lymph node (SCN), and internal mammary lymph node (IMN), while 18 hospitals included only ALN and SCN. The median RND between the WBI and WBI+RNI were as follows: 0.64 vs. 1.05 (ALN level I), 0.27 vs. 1.08 (ALN level II), 0.02 vs. 1.12 (ALN level III), 0.01 vs. 1.12 (SCN), and 0.54 vs. 0.82 (IMN). In all nodal regions, the RND was significantly lower in WBI than in WBI+RNI ( p < 0.01). In this study, we could identify the nodal dose difference between WBI and WBI+RNI.",2020,"In all nodal regions, the RND was significantly lower in WBI than in WBI+RNI ( p < 0.01).","['pN1 breast cancer', 'For RNI, 6 institutions included axillary lymph node (ALN), supraclavicular lymph node (SCN), and internal mammary lymph node (IMN), while 18 hospitals included only ALN and SCN', 'Twenty-four participating institutions']","['whole-breast irradiation (WBI) and whole-breast plus regional lymph node irradiation (WBI+RNI', 'Whole-Breast Plus Regional Lymph Node Irradiation']","['median RND between the WBI and WBI+RNI', 'relative nodal dose (RND']","[{'cui': 'C0332397', 'cui_str': 'pN1 category'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0229730', 'cui_str': 'Structure of supraclavicular lymph node'}, {'cui': 'C0229755', 'cui_str': 'Structure of parasternal lymph node'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038866', 'cui_str': 'Structure of suprachiasmatic nucleus'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0034931', 'cui_str': 'Complex regional pain syndrome type I'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.0271783,"In all nodal regions, the RND was significantly lower in WBI than in WBI+RNI ( p < 0.01).","[{'ForeName': 'Haeyoung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Heejung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Park', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Jong Yun', 'Initials': 'JY', 'LastName': 'Baek', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Sung Ja', 'Initials': 'SJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Radiation Oncology, Chonnam National University Medical School, Gwangju 58128, Korea.'}, {'ForeName': 'Mi Young', 'Initials': 'MY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Kyungpook National University Chilgok Hospital, Daegu 41404, Korea.'}, {'ForeName': 'Shin-Hyung', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Radiation Oncology, Kyungpook National University School of Medicine, Daegu 41944, Korea.'}, {'ForeName': 'Ik Jae', 'Initials': 'IJ', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Korea.'}, {'ForeName': 'Inbong', 'Initials': 'I', 'LastName': 'Ha', 'Affiliation': 'Department of Radiation Oncology, Gyengsang National University Hospital, Gyengsang National University School of Medicine, Jinju 52727, Korea.'}, {'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu 41931, Korea.'}, {'ForeName': 'Tae Hyun', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'National Cancer Center, Research Institute and Hospital, Center for Proton Therapy, Goyang 10408, Korea.'}, {'ForeName': 'Kyu Chan', 'Initials': 'KC', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, Gil Medical Center, Gachon University College of Medicine, Incheon 21565, Korea.'}, {'ForeName': 'Hyung-Sik', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, Dong-A University Hospital, Dong-A University School of Medicine, Busan 49201, Korea.'}, {'ForeName': 'Tae Gyu', 'Initials': 'TG', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon 51353, Korea.'}, {'ForeName': 'Jin Ho', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Seoul National University Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Jong Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ""Department of Radiation Oncology, St. Vincent's Hospital, The Catholic University of Korea, Suwon 16247, Korea.""}, {'ForeName': 'Jinhong', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': 'Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.'}, {'ForeName': 'Oyeon', 'Initials': 'O', 'LastName': 'Cho', 'Affiliation': 'Department of Radiation Oncology, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Jee Suk', 'Initials': 'JS', 'LastName': 'Chang', 'Affiliation': 'Department of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Eun Seog', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Cheonan 31151, Korea.'}, {'ForeName': 'In Young', 'Initials': 'IY', 'LastName': 'Jo', 'Affiliation': 'Department of Radiation Oncology, Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Cheonan 31151, Korea.'}, {'ForeName': 'Taeryool', 'Initials': 'T', 'LastName': 'Koo', 'Affiliation': 'Department of Radiation Oncology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang 14068, Korea.'}, {'ForeName': 'Kyubo', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Ewha Womans University College of Medicine, Seoul 07804, Korea.'}, {'ForeName': 'Hae Jin', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Department of Radiation Oncology, Hanyang University College of Medicine, Seoul 15588, Korea.'}, {'ForeName': 'Young-Joo', 'Initials': 'YJ', 'LastName': 'Shin', 'Affiliation': 'Department of Radiation Oncology, Inje University Sanggye Paik Hospital, Seoul 07804, Korea.'}, {'ForeName': 'Boram', 'Initials': 'B', 'LastName': 'Ha', 'Affiliation': 'Department of Radiation Oncology, Hallylm University Dongtan Sacred Heart Hospital, Hwaseong 14068, Korea.'}, {'ForeName': 'Jeanny', 'Initials': 'J', 'LastName': 'Kwon', 'Affiliation': 'Department of Radiation Oncology, Chungnam National University Hospital, Daejeon 35015, Korea.'}, {'ForeName': 'Ju Hye', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, Pusan National University Yangsan Hospital, Yangsan 50612, Korea.'}, {'ForeName': 'Sunrock', 'Initials': 'S', 'LastName': 'Moon', 'Affiliation': 'Department of Radiation Oncology, Wonkwang University Hospital, Wonkwang University School of Medicine, Iksan 54538, Korea.'}]",Cancers,['10.3390/cancers12113261']
2251,33158369,Exacerbations of asthma following step-up and step-down inhaled corticosteroid and long acting beta agonist therapy in the Managing Asthma in Pregnancy study.,"Guidelines for asthma management contain a consensus recommendation that inhaled corticosteroid (ICS) dose should not be stepped down in pregnancy. However, this is not consistent with consumer preferences and pharmacological principles to minimize medication exposure during pregnancy. We investigated exacerbations after changes to ICS and long acting beta agonist (LABA) therapy in pregnant women with asthma. Pregnant women (n = 220) were recruited to a randomised controlled trial (RCT) where maintenance treatment was adjusted monthly based on either symptoms (control group), or fractional exhaled nitric oxide (FeNO, to alter ICS) and symptoms (to alter LABA, FeNO group). Exacerbations were monitored prospectively. ICS were used by 137 (62.3%) women at some time during pregnancy. ICS dose remained unchanged in 16 women (11.7%, 95% confidence interval [CI] 7-18%), increased in 37 women (27%, 95%CI 20-35%), decreased in 34 women (24.8%, 95%CI 18%-33%), or both increased and decreased in 50 women (36.5%, 95%CI 29-45%). Exacerbations occurred within 14 days of ICS step-down in 11 women (13%, 95%CI 7.5%-22%). This was not significantly different from exacerbations occurring within 14 days of step-up, in 7 women (8.1%, 95%CI 4%-16%, P = 0.294). There were no differences between management groups. Exacerbations occurred within 14 days of step-down in 14.7% (95%CI 7%-30%) of women in the control group, and in 12% (95%CI 6%-24%) of women in the FENO group. ICS step-down could be considered when eosinophilic inflammation or symptoms are low, and may be a useful management approach for women, doctors, and midwives wishing to minimize ICS exposure during pregnancy.",2020,"ICS dose remained unchanged in 16 women (11.7%, 95% confidence interval [CI] 7-18%), increased in 37 women (27%, 95%CI 20-35%), decreased in 34 women (24.8%, 95%CI 18%-33%), or both increased and decreased in 50 women (36.5%, 95%CI 29-45%).","['pregnant women with asthma', 'Pregnant women (n\u2009=\u2009220']","['step-up and step-down inhaled corticosteroid and long acting beta agonist therapy', 'inhaled corticosteroid (ICS', 'ICS and long acting beta agonist (LABA) therapy']","['ICS', 'Exacerbations']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4517650', 'cui_str': '220'}]","[{'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",220.0,0.535785,"ICS dose remained unchanged in 16 women (11.7%, 95% confidence interval [CI] 7-18%), increased in 37 women (27%, 95%CI 20-35%), decreased in 34 women (24.8%, 95%CI 18%-33%), or both increased and decreased in 50 women (36.5%, 95%CI 29-45%).","[{'ForeName': 'Vanessa E', 'Initials': 'VE', 'LastName': 'Murphy', 'Affiliation': 'Priority Research Centre GrowUpWellTM, University of Newcastle and Hunter Medical Research Institute, NSW, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Jensen', 'Affiliation': 'Priority Research Centre GrowUpWellTM, University of Newcastle and Hunter Medical Research Institute, NSW, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Gibson', 'Affiliation': 'Priority Research Centre for Healthy Lungs, University of Newcastle and Hunter Medical Research Institute, NSW, Australia.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1847934']
2252,33158451,Acupuncture for chronic stable angina pectoris based on the theory of Meridian-Viscera Association: study protocol for a multicenter randomized controlled trial.,"BACKGROUND
Acupuncture has long been used to treat chronic stable angina pectoris (CSAP), but the acupuncture prescription for CSAP varies. This trial will compare the therapeutic effects between the acupoints on the Heart Meridian and the acupoints on the Lung Meridian for treating CSAP, so as to provide a better prescription for acupuncture treatment of CSAP.
METHODS
This is a multicenter randomized controlled trial. A total of 148 CSAP patients will be randomly allocated into two groups through central randomization in a 1:1 ratio. This trial will include a 2-week screening period, a 4-week treatment period, and a 4-week follow-up period. The primary outcome is the frequency of angina attacks from baseline to 4 weeks after inclusion. Secondary outcomes include the frequency of angina attacks from baseline to 4 weeks after acupuncture treatment, the pain intensity of angina, total ischemia burden, heart rate variability, QT dispersion, the score of Seattle Angina Questionnaire, and the score of Short-Form of McGill Pain Questionnaire. These outcome measures will be evaluated at baseline, at the end of acupuncture treatment, and at the end of follow-up.
DISCUSSION
We hypothesize that the effectiveness of puncturing at acupoints on the Heart Meridian will not be the same as those on the Lung Meridian. The results will provide further evidence of Meridian-Viscera Association theory and references for acupoints selection in the clinical practice.
TRIAL REGISTRATION
Chinese Clinical Trial Registry ChiCTR1900025804 . Registered on September 9, 2019.",2020,"Secondary outcomes include the frequency of angina attacks from baseline to 4 weeks after acupuncture treatment, the pain intensity of angina, total ischemia burden, heart rate variability, QT dispersion, the score of Seattle Angina Questionnaire, and the score of Short-Form of McGill Pain Questionnaire.",['148 CSAP patients'],['Acupuncture'],"['frequency of angina attacks', 'pain intensity of angina, total ischemia burden, heart rate variability, QT dispersion, the score of Seattle Angina Questionnaire, and the score of Short-Form of McGill Pain Questionnaire']","[{'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C3695257', 'cui_str': 'Frequency of angina'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}]",148.0,0.151981,"Secondary outcomes include the frequency of angina attacks from baseline to 4 weeks after acupuncture treatment, the pain intensity of angina, total ischemia burden, heart rate variability, QT dispersion, the score of Seattle Angina Questionnaire, and the score of Short-Form of McGill Pain Questionnaire.","[{'ForeName': 'Zhaoxuan', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Acupuncture-Brain Research Center, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Wen', 'Affiliation': 'Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yin', 'Affiliation': 'Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Zhengjie', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Peihong', 'Initials': 'P', 'LastName': 'Ma', 'Affiliation': 'Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Yunhong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.'}, {'ForeName': 'Yongliang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Neurobiology and Acupuncture Research/The Third Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Jianqiao', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Neurobiology and Acupuncture Research/The Third Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Lan', 'Affiliation': 'Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China. lanlei@cdutcm.edu.cn.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': 'Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China. zengfang@cdutcm.edu.cn.'}]",Trials,['10.1186/s13063-020-04836-8']
2253,33158501,"Corrigendum to ""The effectiveness of manual-guided, problem-solving-based self-learning programme for family caregivers of people with recent-onset psychosis: A randomised controlled trial with 6-month follow-up"" [International Journal of Nursing Studies 59 (2016) 141-155].",,2020,,['family caregivers of people with recent-onset psychosis'],"['manual-guided, problem-solving-based self-learning programme']",[],"[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",[],,0.0906212,,"[{'ForeName': 'Wai Tong', 'Initials': 'WT', 'LastName': 'Chien', 'Affiliation': 'School of Nursing, Faculty of Health and Social Sciences, The Hong Kong Polytechnic University, Hong Kong Special Administrative Region. Electronic address: chinwaton@gmail.com.'}, {'ForeName': 'Annie L K', 'Initials': 'ALK', 'LastName': 'Yip', 'Affiliation': 'School of Nursing, Faculty of Health and Social Sciences, The Hong Kong Polytechnic University, Hong Kong Special Administrative Region.'}, {'ForeName': 'Justina Y W', 'Initials': 'JYW', 'LastName': 'Liu', 'Affiliation': 'School of Nursing, Faculty of Health and Social Sciences, The Hong Kong Polytechnic University, Hong Kong Special Administrative Region.'}, {'ForeName': 'Terry W', 'Initials': 'TW', 'LastName': 'McMaster', 'Affiliation': 'Department of Psychiatry, University of Alberta, Canada.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103794']
2254,33158554,"Functional connectivity changes and symptoms improvement after personalized, double-daily dosing, repetitive transcranial magnetic stimulation in obsessive-compulsive disorder: A pilot study.","BACKGROUND
intrusive thoughts and compulsive behaviors that characterize obsessive compulsive disorder (OCD) are associated to aberrant resting state functional connectivity (rsFC) patterns within the cortico-striatal-thalamo-cortical (CSTC) circuits. A high percentage of OCD patients do not respond to conventional pharmacological treatments or psychotherapy. In these patients, inhibitory repetitive transcranial magnetic stimulation (rTMS) of the Supplementary Motor Area (SMA) resulted in a significant clinical benefit.
METHODS
In the current study, we applied a novel protocol of 1-week MRI-guided individualized double-daily sessions of rTMS treatment (1-Hz; 110% of resting Motor Threshold/7200 pulses/day), to bilateral SMA in 9 OCD patients. We tested its (i) feasibility-safety, (ii) clinical efficacy and (iii) rsFC related changes.
RESULTS
Patients reported no side effects during and after rTMS. Personalized rTMS treatment led to a significant improvement of OCD symptoms (average 25%; p = .005) and persistence of benefit up to 3-month follow-up. rsFC analysis revealed a significant reduction of connectivity patterns between bilateral SMA and subcortical regions, specifically in the basal ganglia and thalamus. Additional analysis showed that OCD symptoms severity correlates with a higher connectivity pattern between bilateral SMA and subcortical regions.
CONCLUSIONS
rTMS double-daily sessions are safe, feasible and effective in OCD. The clinical outcomes, that are consistent with those found in our previous RCT, are linked to a decreased connectivity between SMA and subcortical brain areas implicated in control over obsessions and maladaptive compulsive behavior.",2020,Personalized rTMS treatment led to a significant improvement of OCD symptoms (average 25%; p = .005) and persistence of benefit up to 3-month follow-up.,"['9 OCD patients', 'obsessive-compulsive disorder']","['Personalized rTMS', 'inhibitory repetitive transcranial magnetic stimulation (rTMS) of the Supplementary Motor Area (SMA', 'rTMS', 'repetitive transcranial magnetic stimulation']","['safe, feasible and effective in OCD', 'connectivity patterns', 'feasibility-safety, (ii) clinical efficacy and (iii) rsFC related changes', 'OCD symptoms']","[{'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",9.0,0.043163,Personalized rTMS treatment led to a significant improvement of OCD symptoms (average 25%; p = .005) and persistence of benefit up to 3-month follow-up.,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Mantovani', 'Affiliation': 'Department of Molecular, Cellular and Biomedical Sciences, CUNY, School of Medicine, New York, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Neri', 'Affiliation': 'Siena Brain Investigation and Neuromodulation Lab (Si-BIN Lab), Unit of Neurology and Clinical Neurophysiology, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy. Electronic address: f.neri@unifi.it.'}, {'ForeName': 'Giordano', 'Initials': 'G', 'LastName': ""D'Urso"", 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mencarelli', 'Affiliation': 'Siena Brain Investigation and Neuromodulation Lab (Si-BIN Lab), Unit of Neurology and Clinical Neurophysiology, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy; Berenson-Allen Center for Non-Invasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Tatti', 'Affiliation': 'Department of Molecular, Cellular and Biomedical Sciences, CUNY, School of Medicine, New York, USA.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Momi', 'Affiliation': 'Siena Brain Investigation and Neuromodulation Lab (Si-BIN Lab), Unit of Neurology and Clinical Neurophysiology, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy; Berenson-Allen Center for Non-Invasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Menardi', 'Affiliation': 'Siena Brain Investigation and Neuromodulation Lab (Si-BIN Lab), Unit of Neurology and Clinical Neurophysiology, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy; Berenson-Allen Center for Non-Invasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Sprugnoli', 'Affiliation': 'Siena Brain Investigation and Neuromodulation Lab (Si-BIN Lab), Unit of Neurology and Clinical Neurophysiology, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Santarnecchi', 'Affiliation': 'Siena Brain Investigation and Neuromodulation Lab (Si-BIN Lab), Unit of Neurology and Clinical Neurophysiology, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy; Berenson-Allen Center for Non-Invasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Rossi', 'Affiliation': 'Siena Brain Investigation and Neuromodulation Lab (Si-BIN Lab), Unit of Neurology and Clinical Neurophysiology, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy; Department of Medicine, Surgery and Neuroscience, University of Siena School of Medicine, Siena, Italy.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.030']
2255,33158633,"The effectiveness of traditional corticotomy vs flapless corticotomy in miniscrew-supported en-masse retraction of maxillary anterior teeth in patients with Class II Division 1 malocclusion: A single-centered, randomized controlled clinical trial.","INTRODUCTION
This single-centered, parallel-groups trial aimed to evaluate the efficacy of traditional corticotomy vs flapless corticotomy in accelerating en-masse retraction. In addition, to assess the skeletal, dental, and soft-tissue variables, as well as the external apical root resorption (EARR) of the maxillary anterior teeth.
METHODS
Forty patients with Class II Division 1 malocclusion aged >18 years at the beginning of treatment, requiring maxillary first premolar extractions, were randomly distributed into 2 groups (n = 20 each): 1 group was treated using traditional corticotomy, and the other group was treated with flapless corticotomy in en-masse retraction with anchorage based on miniscrews placed between maxillary second premolars and first molars bilaterally. Randomization was implemented with a computer-generated list of random numbers; allocation was concealed in sequentially numbered, opaque, sealed envelopes. The study was single-blinded (outcomes' assessor). The primary outcome was the en-masse retraction duration. Secondary outcomes were the skeletal, dental, and soft-tissue changes on lateral cephalometric and the EARR of maxillary anterior teeth on digital panoramic radiographs.
RESULTS
The en-masse retraction duration in the flapless corticotomy group was longer than the traditional corticotomy group. The average retraction duration was 4.04 ± 1.10 months for the flapless corticotomy group and 3.75 ± 2.14 months for the traditional corticotomy group, with no significant difference between the 2 groups (95% confidence interval [CI], -0.81 to 1.39; P = 0.59). No significant differences were observed between the 2 groups regarding changes in several lateral cephalometric variables (eg, SNA angle [95% CI, -2.55° to 1.66°; P = 0.67], SN-U1 angle [95% CI, -1.70° to 1.32°; P = 0.80], and UL-E [95% CI: -1.33 to 1.00 mm; P = 0.78]) or in the amount of EARR in the maxillary anterior teeth (P = 0.31). The proportion of the observed EARR ranged from 1% to 6% of root length in both corticotomy groups. No serious harms were observed in both groups.
CONCLUSIONS
No significant differences between the flapless and traditional corticotomies were found in terms of the skeletal, dental, and soft-tissue variables as well as in the amount of EARR. Corticotomy-assisted en-masse retraction led to improvements in skeletal structures and facial profile and resulted in sufficient retraction of maxillary anterior teeth, slight distal movement of maxillary first molars, and an intrusion movement for both anterior and posterior teeth. Both corticotomy techniques did not cause significant EARR.
REGISTRATION
ClinicalTrials.gov (Identifier: NCT03279042).
PROTOCOL
The protocol was not published before the trial commencement.",2020,"No significant differences were observed between the 2 groups regarding changes in several lateral cephalometric variables (eg, SNA angle [95% CI, -2.55° to 1.66°; P = 0.67], SN-U1 angle [95% CI, -1.70° to 1.32°; P = 0.80], and UL-E [95% CI: -1.33 to 1.00 mm; P = 0.78]) or in the amount of EARR in the maxillary anterior teeth (P = 0.31).","['18\xa0years at the beginning of treatment, requiring maxillary first premolar extractions', 'patients with Class II Division 1 malocclusion', 'Forty patients with Class II Division 1 malocclusion aged']","['traditional corticotomy vs flapless corticotomy', 'traditional corticotomy, and the other group was treated with flapless corticotomy in en-masse retraction with anchorage based on miniscrews placed between maxillary second premolars and first molars bilaterally', 'Corticotomy-assisted en-masse retraction']","['external apical root resorption (EARR) of the maxillary anterior teeth', 'average retraction duration', 'skeletal, dental, and soft-tissue variables', 'flapless and traditional corticotomies', 'skeletal structures and facial profile', 'en-masse retraction duration', 'skeletal, dental, and soft-tissue changes on lateral cephalometric and the EARR of maxillary anterior teeth on digital panoramic radiographs', 'several lateral cephalometric variables']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle class II, division 1'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1290638', 'cui_str': 'Resorption of apex of tooth root'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0424476', 'cui_str': 'Facial profile'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0034579', 'cui_str': 'Orthopantogram'}]",40.0,0.0473728,"No significant differences were observed between the 2 groups regarding changes in several lateral cephalometric variables (eg, SNA angle [95% CI, -2.55° to 1.66°; P = 0.67], SN-U1 angle [95% CI, -1.70° to 1.32°; P = 0.80], and UL-E [95% CI: -1.33 to 1.00 mm; P = 0.78]) or in the amount of EARR in the maxillary anterior teeth (P = 0.31).","[{'ForeName': 'Hanin Nizar', 'Initials': 'HN', 'LastName': 'Khlef', 'Affiliation': 'Department of Orthodontics, University of Damascus Dental School, Damascus University, Damascus, Syria.'}, {'ForeName': 'Mohammad Younis', 'Initials': 'MY', 'LastName': 'Hajeer', 'Affiliation': 'Department of Orthodontics, University of Damascus Dental School, Damascus University, Damascus, Syria. Electronic address: myhajeer@gmail.com.'}, {'ForeName': 'Mowaffak A', 'Initials': 'MA', 'LastName': 'Ajaj', 'Affiliation': 'Department of Orthodontics, University of Damascus Dental School, Damascus University, Damascus, Syria.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Heshmeh', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus University, Damascus, Syria.'}, {'ForeName': 'Nisreen', 'Initials': 'N', 'LastName': 'Youssef', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus University, Damascus, Syria.'}, {'ForeName': 'Luai', 'Initials': 'L', 'LastName': 'Mahaini', 'Affiliation': 'Department of Orthodontics, University of Damascus Dental School, Damascus University, Damascus, Syria.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2020.08.008']
2256,33158702,Impact of Acoustic Noise Reduction on Patient Experience in Routine Clinical Magnetic Resonance Imaging.,"OBJECTIVES
Acoustic noise emission from MRI scanners is considered a major factor of patient discomfort during routine MRI examinations. We prospectively evaluated the impact of acoustic noise reduction using software implementations in routine clinical MRI on subjective patient experience and image quality.
METHODS
Two-hundred consecutive patients undergoing one of four MRI examinations (brain, lumbar spine, shoulder, and knee) at a single center were prospectively randomized into two groups at a 1 to 1 ratio: standard MRI examination and MRI examination with acoustic noise reduction. After the examination, patients were asked to complete a questionnaire aimed at defining their subjective experience (primary endpoint). Two readers assessed subjective image quality of all patient studies in consensus (secondary endpoint). Nonparametric tests and logistic regression models were used for statistical analysis.
RESULTS
Hundred-seventy-four patients were included in the final study. Patients in the intervention group felt less discomforted by the acoustic noise (p = 0.01) and reported increased audibility of music through the headphones (p = 0.03). No significant difference in subjective image quality was found.
CONCLUSION
Our study indicates that the effects of acoustic noise reduction in routine clinical MRI can be translated into reduced patient discomfort from acoustic noise and improved audibility of music. Acoustic noise reduction thus significantly contributes to increased patient comfort during MRI examinations.",2020,Patients in the intervention group felt less discomforted by the acoustic noise (p = 0.01) and reported increased audibility of music through the headphones (p = 0.03).,"['Two-hundred consecutive patients undergoing one of four MRI examinations (brain, lumbar spine, shoulder, and knee) at a single center', 'Hundred-seventy-four patients were included in the final study']","['standard MRI examination and MRI examination with acoustic noise reduction', 'Acoustic Noise Reduction']","['subjective patient experience and image quality', 'subjective image quality', 'acoustic noise', 'audibility of music through the headphones']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0441067', 'cui_str': 'Earphones'}]",200.0,0.0298549,Patients in the intervention group felt less discomforted by the acoustic noise (p = 0.01) and reported increased audibility of music through the headphones (p = 0.03).,"[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Sartoretti', 'Affiliation': 'Department of Radiology, Kantonsspital Winterthur, Brauerstrasse 15, 8405, Winterthur, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sartoretti', 'Affiliation': 'Department of Radiology, Kantonsspital Winterthur, Brauerstrasse 15, 8405, Winterthur, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wyss', 'Affiliation': 'Philips Health Systems, Zürich, Switzerland.'}, {'ForeName': 'Luuk', 'Initials': 'L', 'LastName': 'van Smoorenburg', 'Affiliation': 'Department of Radiology, Kantonsspital Winterthur, Brauerstrasse 15, 8405, Winterthur, Switzerland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichenberger', 'Affiliation': 'Department of Radiology, Kantonsspital Winterthur, Brauerstrasse 15, 8405, Winterthur, Switzerland.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'van der Duim', 'Affiliation': 'Department of Radiology, Kantonsspital Winterthur, Brauerstrasse 15, 8405, Winterthur, Switzerland.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Cereghetti', 'Affiliation': 'Department of Radiology, Kantonsspital Winterthur, Brauerstrasse 15, 8405, Winterthur, Switzerland.'}, {'ForeName': 'Christoph A', 'Initials': 'CA', 'LastName': 'Binkert', 'Affiliation': 'Department of Radiology, Kantonsspital Winterthur, Brauerstrasse 15, 8405, Winterthur, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Sartoretti-Schefer', 'Affiliation': 'Department of Radiology, Kantonsspital Winterthur, Brauerstrasse 15, 8405, Winterthur, Switzerland.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Najafi', 'Affiliation': 'Department of Radiology, Kantonsspital Winterthur, Brauerstrasse 15, 8405, Winterthur, Switzerland. Electronic address: najafi.arash@gmail.com.'}]",Academic radiology,['10.1016/j.acra.2020.10.012']
2257,33158822,"Association between vitamin D and uterine fibroids: a study protocol of an open-label, randomised controlled trial.","INTRODUCTION
Uterine fibroids are the most common pelvic benign tumour with no satisfactory long-term medical treatment. Recent studies have demonstrated that vitamin D significantly inhibited the growth of fibroids in vitro, vivo and a small-sample clinical trial. Therefore, the aim of this randomised clinical trial (RCT) is to evaluate whether supplementation with vitamin D could reduce the risk and inhibit the growth of uterine fibroids in reproductive stage women.
METHODS AND ANALYSIS
The open-label, RCT comprises two parts, including parts I and II. In part I, 2230 vitamin D deficiency or vitamin D insufficiency patients without uterine fibroids will be randomly assigned to two groups: intervention group (according to the level of serum 25-hydroxyvitamin D 3 , receive 1600 or 800 IU/day of vitamin D 3 for 2 years) and control group (followed up at the same time points). By using gynaecological ultrasound examinations, the incidence of uterine fibroids will be employed to measure the outcome in different groups. In part II, 360 uterine fibroids patients with vitamin D deficiency or vitamin D insufficiency will be randomly assigned to intervention group or control group. According to the level of serum 25-hydroxyvitamin D 3 , 180 patients will receive 1600 or 800 IU/day of vitamin D 3 for 2 years. Control group will receive regular follow-up. The outcome measure will be conducted using gynaecological ultrasound examinations to detect the growth of uterine fibroids in each group.
ETHICS AND DISSEMINATION
This study has been approved by the institutional review board of the Second Affiliated Hospital of Wenzhou Medical University (No. LCKY2018-35).
TRIAL REGISTRATION NUMBERS
NCT03586947 and NCT03584529.",2020,"By using gynaecological ultrasound examinations, the incidence of uterine fibroids will be employed to measure the outcome in different groups.","['360 uterine fibroids patients with vitamin D deficiency or vitamin D insufficiency', 'reproductive stage women', 'insufficiency patients without uterine fibroids']","['2230 vitamin D deficiency or vitamin D', 'intervention group (according to the level of serum 25-hydroxyvitamin D 3 , receive 1600 or 800\u2009IU/day of vitamin D 3 for 2 years) and control group', 'vitamin D', 'vitamin D and uterine fibroids']",['growth of uterine fibroids'],"[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}]",180.0,0.163327,"By using gynaecological ultrasound examinations, the incidence of uterine fibroids will be employed to measure the outcome in different groups.","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Sheng', 'Affiliation': 'Obstetrics and Gynecology, Wenzhou Medical University Second Affiliated Hospital, Wenzhou, China.'}, {'ForeName': 'Yizuo', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Obstetrics and Gynecology, Wenzhou Medical University Second Affiliated Hospital, Wenzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Obstetrics and Gynecology, Wenzhou Medical University Second Affiliated Hospital, Wenzhou, China.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Clinical Research Center, Wenzhou Medical University Second Affiliated Hospital, Wenzhou, China.'}, {'ForeName': 'Xueqiong', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Obstetrics and Gynecology, Wenzhou Medical University Second Affiliated Hospital, Wenzhou, China zjwzzxq@163.com.'}]",BMJ open,['10.1136/bmjopen-2020-038709']
2258,33158826,"Using discrete choice experiments to design interventions for heterogeneous preferences: protocol for a pragmatic randomised controlled trial of a preference-informed, heterogeneity-focused, HIV testing offer for high-risk populations.","INTRODUCTION
Approximately one million undiagnosed persons living with HIV in Southern and Eastern Africa need to test for HIV. Novel approaches are necessary to identify HIV testing options that match the heterogeneous testing preferences of high-risk populations. This pragmatic randomised controlled trial (PRCT) will evaluate the efficacy of a preference-informed, heterogeneity-focused HIV counselling and testing (HCT) offer, for improving rates of HIV testing in two high-risk populations.
METHODS AND ANALYSIS
The study will be conducted in Moshi, Tanzania. The PRCT will randomise 600 female barworkers and 600 male Kilimanjaro mountain porters across three study arms. All participants will receive an HIV testing offer comprised of four preference-informed testing options, including one 'common' option-comprising features that are commonly available in the area and, on average, most preferred among study participants-and three options that are specific to the study arm. Options will be identified using mixed logit and latent class analyses of data from a discrete choice experiment (DCE). Participants in Arm 1 will be offered the common option and three 'targeted' options that are predicted to be more preferred than the common option and combine features widely available in the study area. Participants in Arm 2 will be offered the common option and three 'enhanced' options, which also include HCT features that are not yet widely available in the study area. Participants in Arm 3, an active control arm, will be offered the common option and three predicted 'less preferred' options. The primary outcome will be uptake of HIV testing.
ETHICS AND DISSEMINATION
Ethical approval was obtained from the Duke University Health System IRB, the University of South Carolina IRB, the Ethics Review Committee at Kilimanjaro Christian Medical University College, Tanzania's National Institute for Medical Research, and the Tanzania Food & Drugs Authority (now Tanzania Medicines & Medical Devices Authority). Findings will be published in peer-reviewed journals. The use of rigorous DCE methods for the preference-based design and tailoring of interventions could lead to novel policy options and implementation science approaches.
TRIAL REGISTRATION NUMBER
NCT02714140.",2020,"All participants will receive an HIV testing offer comprised of four preference-informed testing options, including one 'common' option-comprising features that are commonly available in the area and, on average, most preferred among study participants-and three options that are specific to the study arm.","['600 female barworkers and 600 male Kilimanjaro mountain porters across three study arms', 'undiagnosed persons living with HIV in Southern and Eastern Africa need to test for HIV', 'two high-risk populations', 'high-risk populations']",['HIV counselling and testing (HCT'],['uptake of HIV testing'],"[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0442533', 'cui_str': 'Mountain'}, {'cui': 'C0402671', 'cui_str': 'Porter'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001741', 'cui_str': 'Eastern Africa'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0730426', 'cui_str': 'Human immunodeficiency virus counseling'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}]",,0.223333,"All participants will receive an HIV testing offer comprised of four preference-informed testing options, including one 'common' option-comprising features that are commonly available in the area and, on average, most preferred among study participants-and three options that are specific to the study arm.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ostermann', 'Affiliation': 'Department of Health Services Policy & Management, University of South Carolina, Columbia, South Carolina, USA jano@mailbox.sc.edu.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Njau', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hobbie', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Mtuy', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Martha L', 'Initials': 'ML', 'LastName': 'Masaki', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Aisa', 'Initials': 'A', 'LastName': 'Shayo', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'van Zwetselaar', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Masnick', 'Affiliation': 'Selway Labs, LLC, Barrington, Rhode Island, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Flaherty', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Derek S', 'Initials': 'DS', 'LastName': 'Brown', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Axel C', 'Initials': 'AC', 'LastName': 'Mühlbacher', 'Affiliation': 'Center for Health Policy & Inequalities Research, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Nathan M', 'Initials': 'NM', 'LastName': 'Thielman', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, North Carolina, USA.'}]",BMJ open,['10.1136/bmjopen-2020-039313']
2259,33158841,Correction: (Rad 8)Caffeine prophylaxis to improve intermittent hypoxaemia in infants born late preterm: a randomised controlled dosage trial (Latte Dosage Trial).,,2020,,['infants born late preterm'],['Correction: (Rad 8)Caffeine prophylaxis'],['intermittent hypoxaemia'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0406775', 'cui_str': 'Symmetrical dyschromatosis of extremities'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]",,0.0637444,,[],BMJ open,['10.1136/bmjopen-2020-038271corr1']
2260,33158856,A psychological intervention strengthens students' peer social networks and promotes persistence in STEM.,"Retaining students in science, technology, engineering, and math (STEM) fields is critical as demand for STEM graduates increases. Whereas many approaches to improve persistence target individuals' internal beliefs, skills, and traits, the intervention in this experiment strengthened students' peer social networks to help them persevere. Students in a gateway biology course were randomly assigned to complete a control or values affirmation exercise, a psychological intervention hypothesized to have positive social effects. By the end of the term, affirmed students had an estimated 29% more friends in the course on average than controls. Affirmation also prompted structural changes in students' network positions such that affirmed students were more central in the overall course friendship network. These differing social trajectories predicted STEM persistence: Affirmed students were 11.7 percentage points more likely than controls to take the next course in the bioscience sequence, an effect that was statistically mediated by students' end-of-semester friendships.",2020,Affirmation also prompted structural changes in students' network positions such that affirmed students were more central in the overall course friendship network.,['Students in a gateway biology course'],"['control or values affirmation exercise, a psychological intervention']",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0005532', 'cui_str': 'Biology'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0199658,Affirmation also prompted structural changes in students' network positions such that affirmed students were more central in the overall course friendship network.,"[{'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Turetsky', 'Affiliation': 'Department of Psychology, Columbia University, New York, NY, USA. kturetsky@princeton.edu.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Purdie-Greenaway', 'Affiliation': 'Department of Psychology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Cook', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Curley', 'Affiliation': 'Department of Psychology, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Geoffrey L', 'Initials': 'GL', 'LastName': 'Cohen', 'Affiliation': 'Graduate School of Education and Department of Psychology, Stanford University, Stanford, CA, USA.'}]",Science advances,['10.1126/sciadv.aba9221']
2261,33158945,The Effect of Standard Versus Longer Intestinal Bypass on GLP-1 Regulation and Glucose Metabolism in Patients With Type 2 Diabetes Undergoing Roux-en-Y Gastric Bypass: The Long-Limb Study.,"OBJECTIVE
Roux-en-Y gastric bypass (RYGB) characteristically enhances postprandial levels of glucagon-like peptide 1 (GLP-1), a mechanism that contributes to its profound glucose-lowering effects. This enhancement is thought to be triggered by bypass of food to the distal small intestine with higher densities of neuroendocrine L-cells. We hypothesized that if this is the predominant mechanism behind the enhanced secretion of GLP-1, a longer intestinal bypass would potentiate the postprandial peak in GLP-1, translating into higher insulin secretion and, thus, additional improvements in glucose tolerance. To investigate this, we conducted a mechanistic study comparing two variants of RYGB that differ in the length of intestinal bypass.
RESEARCH DESIGN AND METHODS
A total of 53 patients with type 2 diabetes (T2D) and obesity were randomized to either standard limb RYGB (50-cm biliopancreatic limb) or long limb RYGB (150-cm biliopancreatic limb). They underwent measurements of GLP-1 and insulin secretion following a mixed meal and insulin sensitivity using euglycemic hyperinsulinemic clamps at baseline and 2 weeks and at 20% weight loss after surgery.
RESULTS
Both groups exhibited enhancement in postprandial GLP-1 secretion and improvements in glycemia compared with baseline. There were no significant differences in postprandial peak concentrations of GLP-1, time to peak, insulin secretion, and insulin sensitivity.
CONCLUSIONS
The findings of this study demonstrate that lengthening of the intestinal bypass in RYGB does not affect GLP-1 secretion. Thus, the characteristic enhancement of GLP-1 response after RYGB might not depend on delivery of nutrients to more distal intestinal segments.",2020,"There were no significant differences in postprandial peak concentrations of GLP-1, time to peak, insulin secretion, and insulin sensitivity.
","['53 patients with type 2 diabetes (T2D) and obesity', 'Patients With Type 2 Diabetes Undergoing Roux-en-Y Gastric Bypass']","['standard limb RYGB (50-cm biliopancreatic limb) or long limb RYGB (150-cm biliopancreatic limb', 'Roux-en-Y gastric bypass (RYGB', 'Standard Versus Longer Intestinal Bypass']","['postprandial peak concentrations of GLP-1, time to peak, insulin secretion, and insulin sensitivity', 'postprandial GLP-1 secretion', 'GLP-1 Regulation and Glucose Metabolism', 'glycemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0021829', 'cui_str': 'Intestinal Bypass'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]",53.0,0.0281874,"There were no significant differences in postprandial peak concentrations of GLP-1, time to peak, insulin secretion, and insulin sensitivity.
","[{'ForeName': 'Alexander Dimitri', 'Initials': 'AD', 'LastName': 'Miras', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, U.K.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kamocka', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, U.K.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Pérez-Pevida', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, U.K.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Purkayastha', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, U.K.'}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Moorthy', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, U.K.'}, {'ForeName': 'Ameet', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': ""Department of Surgery, King's College London, London, U.K.""}, {'ForeName': 'Harvinder', 'Initials': 'H', 'LastName': 'Chahal', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, U.K.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Frost', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, U.K.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'StatsConsultancy Ltd., London, U.K.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Castagnetto-Gissey', 'Affiliation': ""Department of Surgery, King's College London, London, U.K.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Coppin', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, U.K.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Jackson', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, U.K.'}, {'ForeName': 'Anne Margot', 'Initials': 'AM', 'LastName': 'Umpleby', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, U.K.'}, {'ForeName': 'Stephen Robert', 'Initials': 'SR', 'LastName': 'Bloom', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, U.K.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Tan', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, U.K.'}, {'ForeName': 'Ahmed Rashid', 'Initials': 'AR', 'LastName': 'Ahmed', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, U.K.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Rubino', 'Affiliation': ""Department of Surgery, King's College London, London, U.K. francesco.rubino@kcl.ac.uk.""}]",Diabetes care,['10.2337/dc20-0762']
2262,33158948,Improvements in Glycemic Control After Acute Moderate-Intensity Continuous or High-Intensity Interval Exercise Are Greater in South Asians Than White Europeans With Nondiabetic Hyperglycemia: A Randomized Crossover Study.,"OBJECTIVE
To examine whether circulating metabolic responses to low-volume high-intensity interval exercise (LV-HIIE) or continuous moderate-intensity aerobic exercise (CME) differ between white Europeans and South Asians with nondiabetic hyperglycemia (NDH).
RESEARCH DESIGN AND METHODS
Thirteen white Europeans and 10 South Asians (combined median [interquartile range] age 67 [60-68] years, HbA 1c 5.9% [5.8-6.1%] [41.0 (39.9-43.2) mmol ⋅ mol -1 ]) completed three 6-h conditions (sedentary control [CON], LV-HIIE, CME) in a randomized order. Exercise conditions contained a single bout of LV-HIIE and CME, respectively (each ending at 2 h), with meals provided at 0 and 3 h. Circulating glucose (primary outcome), insulin, insulin resistance index (IRI), triglycerides, and nonesterified fatty acids were measured at 0, 0.5, 1, 2, 3, 3.5, 4, 5, and 6 h. Data were analyzed as postexercise time-averaged area under the curve (AUC) adjusted for age, sex, and preexercise AUC.
RESULTS
Glucose was similar in each condition and with ethnicity, with no condition-by-ethnicity interaction ( P ≥ 0.28). However, insulin was lower in LV-HIIE (mean [95% CI] -44.4 [-23.7, -65.1] mU ⋅ L -1 ) and CME (-33.8 [-13.7, -53.9] mU ⋅ L -1 ) compared with CON. Insulin responses were greater in South Asians (interaction P = 0.03) such that values were similar in each ethnicity during exercise conditions, despite being 33% higher in South Asians during CON. IRI followed a similar pattern to insulin. Lipids were unaffected by exercise.
CONCLUSIONS
Reductions in insulin and insulin resistance after acute LV-HIIE and CME are greater in South Asians than in white Europeans with NDH. Further trials are required to examine the longer-term impact of LV-HIIE and CME on cardiometabolic health.",2020,"Insulin responses were greater in South Asians (interaction P = 0.03) such that values were similar in each ethnicity during exercise conditions, despite being 33% higher in South Asians during CON.","['white Europeans and South Asians with nondiabetic hyperglycemia (NDH', 'Thirteen white Europeans and 10 South Asians (combined median [interquartile range] age 67 [60-68] years, HbA 1c 5.9% [5.8-6.1%] [41.0 (39.9-43.2) mmol ⋅ mol -1 ]) completed three', 'South Asians Than White Europeans With Nondiabetic Hyperglycemia']","['Interval Exercise', 'low-volume high-intensity interval exercise (LV-HIIE) or continuous moderate-intensity aerobic exercise (CME', '6-h conditions (sedentary control [CON], LV-HIIE, CME', 'CON']","['postexercise time-averaged area under the curve (AUC) adjusted for age, sex, and preexercise AUC', 'Glycemic Control', 'Insulin responses', 'Circulating glucose (primary outcome), insulin, insulin resistance index (IRI), triglycerides, and nonesterified fatty acids']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]",,0.114935,"Insulin responses were greater in South Asians (interaction P = 0.03) such that values were similar in each ethnicity during exercise conditions, despite being 33% higher in South Asians during CON.","[{'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Sargeant', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K. js928@leicester.ac.uk.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Jelleyman', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Coull', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Edwardson', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Henson', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'NIHR Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'McCarthy', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Alex V', 'Initials': 'AV', 'LastName': 'Rowlands', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': 'NIHR Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'Waller', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Webb', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}]",Diabetes care,['10.2337/dc20-1393']
2263,33158952,Erratum. Risk of Severe Hypoglycemia in Type 1 Diabetes Over 30 Years of Follow-up in the DCCT/EDIC Study. Diabetes Care 2017;40:1010-1016.,,2020,,['Diabetes'],[],[],"[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",[],[],,0.0202795,,"[{'ForeName': 'Rose A', 'Initials': 'RA', 'LastName': 'Gubitosi-Klug', 'Affiliation': ''}, {'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'Braffett', 'Affiliation': ''}, {'ForeName': 'Neil H', 'Initials': 'NH', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Sherwin', 'Affiliation': ''}, {'ForeName': 'F John', 'Initials': 'FJ', 'LastName': 'Service', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Lachin', 'Affiliation': ''}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Tamborlane', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc21-er01a']
2264,33159002,The Effectiveness of Working Memory Training for Children With Low Working Memory.,"OBJECTIVES
Subgroups of children may benefit more from working memory training than others. In this study, we aimed to examine whether response to the Cogmed Working Memory Training program differed for children with low IQ and elevated attention-deficit/hyperactivity disorder, emotional and behavioral symptoms, special health care needs, or by sex.
METHODS
We used data from the Memory Maestros trial, a population-based randomized controlled trial of the Cogmed program delivered at school ( n = 226) compared to usual teaching ( n = 226) in grade 1 children (mean age 6.9 years; SD 0.4) with low working memory. Cogmed comprises 20 to 25 sessions of 45-minute duration over 5 to 7 weeks. Children completed subtests from the Automated Working Memory Assessment to measure change in working memory from baseline to 6 months postrandomization.
RESULTS
After training, improved working memory standard scores (>1 SD) from baseline to 6 months were observed for approximately one-third of the children, with more than half maintaining stable scores (within 1 SD). However, similar outcomes were observed for children receiving usual teaching. Differential effect of Cogmed versus usual teaching was evident for children with elevated hyperactivity and/or inattention, who were less likely to show improved visuospatial working memory, but not for other subgroups studied.
CONCLUSIONS
Children with elevated hyperactivity and/or inattention were less likely to show clinically meaningful improvement after Cogmed; however, differential effects were not evident for children with low IQ and elevated emotional and behavioral symptoms, special health care needs, or by sex. More research is needed to determine if training can improve working memory and, if so, for whom.",2020,"Differential effect of Cogmed versus usual teaching was evident for children with elevated hyperactivity and/or inattention, who were less likely to show improved visuospatial working memory, but not for other subgroups studied.
","[' n = 226) in grade 1 children (mean age 6.9 years; SD 0.4) with low working memory', 'children with low IQ and elevated attention-deficit/hyperactivity disorder, emotional and behavioral symptoms, special health care needs, or by sex', 'children with elevated hyperactivity and/or inattention', 'Children With Low Working Memory']","['Cogmed Working Memory Training program', 'Working Memory Training', 'Cogmed program delivered at school ( n = 226) compared to usual teaching', 'Cogmed versus usual teaching']","['working memory standard scores', 'visuospatial working memory']","[{'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.188132,"Differential effect of Cogmed versus usual teaching was evident for children with elevated hyperactivity and/or inattention, who were less likely to show improved visuospatial working memory, but not for other subgroups studied.
","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Spencer-Smith', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia; megan.spencer-smith@monash.edu.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Quach', 'Affiliation': 'Population Health Theme, and.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Mensah', 'Affiliation': 'Population Health Theme, and.'}, {'ForeName': 'Gehan', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'Population Health Theme, and.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gathercole', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, United Kingdom; and.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wake', 'Affiliation': 'Population Health Theme, and.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Anderson', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}]",Pediatrics,['10.1542/peds.2019-4028']
2265,33159007,Quadratus lumborum block: an imaging study of three approaches.,"BACKGROUND AND OBJECTIVES
Different injection techniques for the quadratus lumborum (QL) block have been described. Data in human cadavers suggest that the transverse oblique paramedian (TOP) QL3 may reach the thoracic paravertebral space more consistently than the QL1 and QL2. However, the distribution of injectate in cadavers may differ from that in patients. Hence, we assessed the distribution of the injectate after the QL1, QL2, and TOP QL3 techniques in patients.
MATERIALS AND METHODS
Thirty-four patients scheduled for abdominal surgery received QL blocks postoperatively; 26 patients received bilateral and 8 patients received unilateral blocks. Block injections were randomly allocated to QL1, QL2, or TOP QL3 techniques (20 blocks per each technique). The injections consisted of 18 mL of ropivacaine 0.375% with 2 mL of radiopaque contrast, injected lateral or posterior to the QL muscle for the QL1 and QL2 techniques, respectively. For the TOP QL3, the injection was into the plane between the QL and psoas muscles, proximal to the L2 transverse process. Two reviewers, blinded to the allocation, reviewed three-dimensional computed tomography (3D-CT) images to assess the distribution of injectate.
RESULTS AND DISCUSSION
The QL1 block spread in the transversus abdominis plane (TAP), QL2 in the TAP, and posterior aspect of the QL muscle, whereas TOP QL3 spread consistently in the anterior aspect of the QL muscle with occasional spread to the lumbar and thoracic paravertebral areas.
CONCLUSIONS
The spread of injectate after QL1, QL2, and QL3 blocks, resulted in different distribution patterns, primarily in the area of injection. The TOP QL3 did not result in consistent interfascial spread toward the thoracic paravertebral space.",2020,"The spread of injectate after QL1, QL2, and QL3 blocks, resulted in different distribution patterns, primarily in the area of injection.",['Thirty-four patients scheduled for abdominal surgery received QL blocks postoperatively; 26 patients received bilateral and 8 patients received'],"['QL1, QL2, or TOP QL3 techniques', 'unilateral blocks', 'ropivacaine']",[],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0441993', 'cui_str': 'Paramedian approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]",[],34.0,0.0455572,"The spread of injectate after QL1, QL2, and QL3 blocks, resulted in different distribution patterns, primarily in the area of injection.","[{'ForeName': 'Angela Lucia', 'Initials': 'AL', 'LastName': 'Balocco', 'Affiliation': 'Anesthesiology, Ziekenhuis Oost-Limburg, Genk, Limburg, Belgium.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'López', 'Affiliation': 'Anesthesiology, Ziekenhuis Oost-Limburg, Genk, Limburg, Belgium.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Kesteloot', 'Affiliation': 'Anesthesiology, Clinique Sainte-Anne Saint-Remi, Brussels, Belgium.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Horn', 'Affiliation': 'Anesthesiology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Brichant', 'Affiliation': 'Anesthesiology and Intensive Care Medicine, Centre Hospitalier Universitaire de Liège, Liege, Belgium.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Vandepitte', 'Affiliation': 'Anesthesiology, Ziekenhuis Oost-Limburg, Genk, Limburg, Belgium.'}, {'ForeName': 'Admir', 'Initials': 'A', 'LastName': 'Hadzic', 'Affiliation': 'Anesthesiology, Ziekenhuis Oost-Limburg, Genk, Limburg, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gautier', 'Affiliation': 'Anesthesiology, Clinique Sainte-Anne Saint-Remi, Brussels, Belgium p.gautier@skynet.be.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101554']
2266,33159033,Oxytocin treatment attenuates amygdala activity in autism: a treatment-mechanism study with long-term follow-up.,"Intranasal administration of the neuropeptide oxytocin (IN-OT) is increasingly considered as a potential treatment for targeting the core symptoms of autism spectrum disorder (ASD), but the effects of continual use on neural substrates are fairly unexplored and long-term effects are unknown. In this double-blind, randomized, placebo-controlled study, we investigated the effects of single-dose and multiple-dose IN-OT treatment (4 weeks of daily (24 IU) administrations) on brain activity related to processing emotional states. Thirty-eight adult men with ASD (aged between 18 and 35 years) underwent functional magnetic resonance imaging of the posterior superior temporal gyrus (pSTS) and amygdala regions while processing emotional states from point-light biological motion. In line with prior research, a single dose of IN-OT induced a reliable increase in pSTS brain activity during the processing of point-light biological motion, but no consistent long-term changes in pSTS activity were induced after the multiple-dose treatment. In terms of bilateral amygdala, the multiple-dose treatment induced a consistent attenuation in brain activity, which outlasted the period of actual administrations until four weeks and one year post-treatment. Critically, participants with stronger attenuations in amygdala-activity showed greater behavioral improvements, particularly in terms of self-reported feelings of avoidant attachment and social functioning. Together, these observations provide initial insights into the long-lasting neural consequences of chronic IN-OT use on amygdala functioning and provide first indications that the acute versus chronic effects of IN-OT administration may be qualitatively different. Larger studies are however warranted to further elucidate the long-term impact of IN-OT treatment on human neural substrates and its behavioral consequences.",2020,"Critically, participants with stronger attenuations in amygdala-activity showed greater behavioral improvements, particularly in terms of self-reported feelings of avoidant attachment and social functioning.","['autism', 'Thirty-eight adult men with ASD (aged between 18 and 35 years) underwent']","['neuropeptide oxytocin (IN-OT', 'single-dose and multiple-dose IN-OT treatment', 'functional magnetic resonance imaging of the posterior superior temporal gyrus (pSTS) and amygdala regions while processing emotional states from point-light biological motion', 'placebo', 'Oxytocin']","['self-reported feelings of avoidant attachment and social functioning', 'pSTS brain activity', 'pSTS activity', 'amygdala activity', 'brain activity related to processing emotional states', 'brain activity', 'behavioral improvements']","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0001560', 'cui_str': 'Medication administration: nasal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C3850033', 'cui_str': 'Posterior Superior Temporal Gyrus'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C3850033', 'cui_str': 'Posterior Superior Temporal Gyrus'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",38.0,0.0950709,"Critically, participants with stronger attenuations in amygdala-activity showed greater behavioral improvements, particularly in terms of self-reported feelings of avoidant attachment and social functioning.","[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bernaerts', 'Affiliation': 'Department of Rehabilitation Sciences, Research Group for Neurorehabilitation, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Boets', 'Affiliation': 'Leuven Autism Research (LAuRes), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Steyaert', 'Affiliation': 'Leuven Autism Research (LAuRes), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wenderoth', 'Affiliation': 'Department of Health Sciences and Technology, Neural Control of Movement Lab, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Kaat', 'Initials': 'K', 'LastName': 'Alaerts', 'Affiliation': 'Department of Rehabilitation Sciences, Research Group for Neurorehabilitation, KU Leuven, Leuven, Belgium. kaat.alaerts@kuleuven.be.'}]",Translational psychiatry,['10.1038/s41398-020-01069-w']
2267,33154177,Relationship between nitrate headache and outcome in patients with acute stroke: results from the efficacy of nitric oxide in stroke (ENOS) trial.,"INTRODUCTION
Nitrate-induced headache is common and may signify responsive cerebral vasculature. We assessed the relationship between nitrate headache and outcome in patients with acute stroke.
MATERIALS AND METHODS
Patients were those randomised to glyceryl trinitrate (GTN) versus no GTN in the efficacy of nitric oxide in stroke trial. Development of headache by end of treatment (day 7), and functional outcome (modified Rankin Scale, primary outcome) at day 90, were assessed. Analyses are adjusted for baseline prognostic factors and give OR and mean difference (MD) with 95% CI.
RESULTS
In 4011 patients, headache was more common in GTN than control (360, 18.0% vs 170, 8.5%; p<0.001). Nitrate-related headache was associated with: younger age, female sex, higher diastolic blood pressure, non-total anterior circulation syndrome, milder stroke and absence of dysphasia (p<0.05). Nitrate headache was not associated with improved functional outcome (OR 0.90, 95% CI 0.73 to 1.10, p=0.30) or death (day 90) (HR 0.64, 95% CI 0.40 to 1.02, p=0.062), but reduced death or deterioration (day 7) (OR 0.45, 95% CI 0.25 to 0.82), death in hospital (OR 0.44, 95% CI 0.22 to 0.88) and improved activities of daily living (Barthel index, MD 3.7, 95% CI 0.3 to 7.1) and cognition (telephone interview cognitive screen, MD 2.0, 95% CI 0.7 to 3.3) (day 90). Non-nitrate headache was not associated with death, disability or cognition.
DISCUSSION AND CONCLUSION
Development of a nitrate headache by day 7 after stroke may be associated with improved activities of daily living and cognitive impairment at day 90, which was not seen with non-nitrate headache.",2020,"Nitrate headache was not associated with improved functional outcome (OR 0.90, 95% CI 0.73 to 1.10, p=0.30) or death (day 90) (HR 0.64, 95% CI 0.40 to 1.02, p=0.062), but reduced death or deterioration (day 7) (OR 0.45, 95% CI 0.25 to 0.82), death in hospital (OR 0.44, 95% CI 0.22 to 0.88) and improved activities of daily living (Barthel index, MD 3.7, 95% CI 0.3 to 7.1) and cognition (telephone interview cognitive screen, MD 2.0, 95% CI 0.7 to 3.3)","['Patients', 'patients with acute stroke']","['nitric oxide', 'glyceryl trinitrate (GTN) versus no GTN']","['headache', 'activities of daily living and cognitive impairment', 'death', 'improved activities of daily living', 'death, disability or cognition', 'Nitrate-related headache', 'functional outcome', 'death in hospital', 'Nitrate headache', 'reduced death or deterioration', 'cognition (telephone interview cognitive screen']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0277608', 'cui_str': 'Death in hospital'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",4011.0,0.184041,"Nitrate headache was not associated with improved functional outcome (OR 0.90, 95% CI 0.73 to 1.10, p=0.30) or death (day 90) (HR 0.64, 95% CI 0.40 to 1.02, p=0.062), but reduced death or deterioration (day 7) (OR 0.45, 95% CI 0.25 to 0.82), death in hospital (OR 0.44, 95% CI 0.22 to 0.88) and improved activities of daily living (Barthel index, MD 3.7, 95% CI 0.3 to 7.1) and cognition (telephone interview cognitive screen, MD 2.0, 95% CI 0.7 to 3.3)","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Beishon', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK lb330@le.ac.uk.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Woodhouse', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bereczki', 'Affiliation': 'Department of Neurology, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Hanne K', 'Initials': 'HK', 'LastName': 'Christensen', 'Affiliation': 'Bispebjerg Hospital and University of Copenhagen, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'Collins', 'Affiliation': 'Department of Geriatric and Stroke Medicine, Adelaide and Meath Hospital, Dublin, Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gommans', 'Affiliation': ""Department of Medicine, Hawke's Bay Hospital, Camberley, New Zealand.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kruuse', 'Affiliation': 'Department of Neurology, Herlev Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Ntaios', 'Affiliation': 'Department of Medicine, Larissa University Hospital, University of Thessaly, Volos, Greece.'}, {'ForeName': 'Serefnur', 'Initials': 'S', 'LastName': 'Ozturk', 'Affiliation': 'Department of Neurology, Selcuk University Medical Faculty, Konya, Turkey.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Phillips', 'Affiliation': 'Department of Neurology, Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Medical Statistics Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Szabolcs', 'Initials': 'S', 'LastName': 'Szatmari', 'Affiliation': 'Department of Neurology, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Târgu Mureș, Targu Mures, Romania.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wardlaw', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke and vascular neurology,['10.1136/svn-2020-000498']
2268,33154182,Efficacy of spoken word comprehension therapy in patients with chronic aphasia: a cross-over randomised controlled trial with structural imaging.,"OBJECTIVE
The efficacy of spoken language comprehension therapies for persons with aphasia remains equivocal. We investigated the efficacy of a self-led therapy app, 'Listen-In', and examined the relation between brain structure and therapy response.
METHODS
A cross-over randomised repeated measures trial with five testing time points (12-week intervals), conducted at the university or participants' homes, captured baseline (T 1 ), therapy (T 2 -T 4 ) and maintenance (T 5 ) effects. Participants with chronic poststroke aphasia and spoken language comprehension impairments completed consecutive Listen-In and standard care blocks (both 12 weeks with order randomised). Repeated measures analyses of variance compared change in spoken language comprehension on two co-primary outcomes over therapy versus standard care. Three structural MRI scans (T 2 -T 4 ) for each participant (subgroup, n=25) were analysed using cross-sectional and longitudinal voxel-based morphometry.
RESULTS
Thirty-five participants completed, on average, 85 hours (IQR=70-100) of Listen-In (therapy first, n=18). The first study-specific co-primary outcome (Auditory Comprehension Test (ACT)) showed large and significant improvements for trained spoken words over therapy versus standard care (11%, Cohen's d=1.12). Gains were largely maintained at 12 and 24 weeks. There were no therapy effects on the second standardised co-primary outcome (Comprehensive Aphasia Test: Spoken Words and Sentences). Change on ACT trained words was associated with volume of pretherapy right hemisphere white matter and post-therapy grey matter tissue density changes in bilateral temporal lobes.
CONCLUSIONS
Individuals with chronic aphasia can improve their spoken word comprehension many years after stroke. Results contribute to hemispheric debates implicating the right hemisphere in therapy-driven language recovery. Listen-In will soon be available on GooglePlay.
TRIAL REGISTRATION NUMBER
NCT02540889.",2020,There were no therapy effects on the second standardised co-primary outcome (Comprehensive Aphasia Test: Spoken Words and Sentences).,"['Participants with chronic poststroke aphasia and spoken language comprehension impairments completed consecutive Listen-In and standard care blocks (both 12\u2009weeks with order randomised', 'patients with chronic aphasia', 'persons with aphasia remains equivocal']","['spoken word comprehension therapy', 'spoken language comprehension therapies']","['second standardised co-primary outcome (Comprehensive Aphasia Test: Spoken Words and Sentences', 'spoken language comprehension']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0424919', 'cui_str': 'Language spoken'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332241', 'cui_str': 'Equivocal'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0424919', 'cui_str': 'Language spoken'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4505400', 'cui_str': 'Comprehensive Aphasia Test'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0424919', 'cui_str': 'Language spoken'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",25.0,0.0814658,There were no therapy effects on the second standardised co-primary outcome (Comprehensive Aphasia Test: Spoken Words and Sentences).,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Fleming', 'Affiliation': 'UCL Queen Square Institute of Neurology, University College London, London, UK victoria.fleming@ucl.ac.uk.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Brownsett', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Saint Lucia, Queensland, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Krason', 'Affiliation': 'Department of Psychology and Language Sciences, University College London, London, UK.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Maegli', 'Affiliation': 'Department of Psychology, Universidad del Valle de Guatemala, Guatemala, Guatemala.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Coley-Fisher', 'Affiliation': 'UCL Queen Square Institute of Neurology, University College London, London, UK.'}, {'ForeName': 'Yean-Hoon', 'Initials': 'YH', 'LastName': 'Ong', 'Affiliation': 'UCL Queen Square Institute of Neurology, University College London, London, UK.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Nardo', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Leach', 'Affiliation': 'UCL Queen Square Institute of Neurology, University College London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Howard', 'Affiliation': 'School of Education, Communication and Language Sciences, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Robson', 'Affiliation': 'Psychology and Clinical Language Sciences, University of Reading, Reading, Berkshire, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Warburton', 'Affiliation': 'Department of Medicine, University of Cambridge, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ashburner', 'Affiliation': 'Wellcome Centre for Human Neuroimaging, University College London, London, UK.'}, {'ForeName': 'Cathy J', 'Initials': 'CJ', 'LastName': 'Price', 'Affiliation': 'Wellcome Centre for Human Neuroimaging, University College London, London, UK.'}, {'ForeName': 'Jenny T', 'Initials': 'JT', 'LastName': 'Crinion', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Leff', 'Affiliation': 'UCL Queen Square Institute of Neurology, University College London, London, UK.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2020-324256']
2269,33154214,Use of thopaz in patients of empyema thoracis undergoing decortication.,"Introduction
The management of empyema thoracis has evolved over the years. After all lung surgeries chest drain is required, however they suffer from inter observer variability and impair mobility of the patient. However, the newer digital thoracic drain system are portable and have alarms for various situations, furthermore they eliminate inter-observer variability. One such device is Thopaz™ (Medela inc, Switzerland). We wanted to compare efficacy of Thopaz™ with our conventional intercostal chest tube drain in patients undergoing decortications for empyema thoracis.
Materials and Methods
One hundred patients were enrolled in study and were randomized into conventional and thopaz group with 50 patients in each group with help of opaque envelopes.
Results
Both the groups were comparable in demographic parameters. Majority of the patients in our study were children and young adults. Majority of empyema thoracis involved right side with nontubercular empyema thoracis being the most common cause of decorticartion. Patients managed with Thopaz had a significantly shorter air leak duration, shorter duration of postdecortication chest tube placement and shorter postoperative hospital stay. All postoperative complications were less in Thopaz group.
Conclusions
Patients with empyema thoracis undergoing open decortications when managed with digital chest drainage system (Thopaz) experienced faster reduction in air leak, a shorter duration of chest tube placement and in hospital stay. Thopaz usage is also associated with reduction in rate of postoperative complications. We recommend that this digital chest tube drainage system is a very useful tool in armamentarium of thoracic surgeon after lung surgeries.",2020,"Patients managed with Thopaz had a significantly shorter air leak duration, shorter duration of postdecortication chest tube placement and shorter postoperative hospital stay.","['patients undergoing decortications for empyema thoracis', 'patients of empyema thoracis undergoing decortication', 'Materials and Methods\n\n\nOne hundred patients were enrolled in study and were randomized into conventional and thopaz group with 50 patients in each group with help of opaque envelopes']","['Thopaz', 'digital chest drainage system (Thopaz', 'conventional intercostal chest tube drain', 'thopaz', 'digital chest tube drainage system']","['air leak, a shorter duration of chest tube placement and in hospital stay', 'rate of postoperative complications', 'All postoperative complications', 'shorter air leak duration, shorter duration of postdecortication chest tube placement and shorter postoperative hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007778', 'cui_str': 'Brain decortication'}, {'cui': 'C0014013', 'cui_str': 'Abscess of pleural cavity'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0029053', 'cui_str': 'Decreased translucency'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0189476', 'cui_str': 'Insertion of pleural tube drain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",100.0,0.0299299,"Patients managed with Thopaz had a significantly shorter air leak duration, shorter duration of postdecortication chest tube placement and shorter postoperative hospital stay.","[{'ForeName': 'Mohd Shahnawaz', 'Initials': 'MS', 'LastName': 'Alam', 'Affiliation': 'Department of General Surgery, JNMC, AMU, Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Mohd Azam', 'Initials': 'MA', 'LastName': 'Haseen', 'Affiliation': 'Department of Cardiothoracic Surgery, JNMC, AMU, Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Mohd', 'Initials': 'M', 'LastName': 'Aslam', 'Affiliation': 'Department of Surgery, JNMC, AMU, Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Mohd Hanif', 'Initials': 'MH', 'LastName': 'Beg', 'Affiliation': 'Department of Cardiothoracic Surgery, JNMC, AMU, Aligarh, Uttar Pradesh, India.'}]",Lung India : official organ of Indian Chest Society,['10.4103/lungindia.lungindia_344_19']
2270,33154684,Comparison of Repeated Video Display vs Combined Video Display and Live Demonstration as Training Methods to Healthcare Providers for Donning and Doffing Personal Protective Equipment: A Randomized Controlled Trial.,"Purpose
The lack of training in personal protective equipment (PPE) donning and doffing is hindering the current fight against the COVID-19 worldwide. In order to enable medical staff to learn how to don and doff PPE faster and more effectively, we compared two training methods of PPE donning and doffing.
Methods
Participants in this study were 48 health care workers randomly divided into two groups. Group A watched a 10-minute demonstration (demo) video four times, while Group B watched the same 10-minute demo video twice and then watched a 10-minute live demo twice. The 40-minute learning time was the same for both groups. A 29-step examination was held after the training was completed. The examination scores of Groups A and B were recorded according to a checklist containing PPE donning and doffing steps . The time spent by the participants on PPE donning and doffing, their satisfaction with the training, and their confidence in donning and doffing PPE accurately were analyzed.
Results
The average score of Group B was higher than that Group A, with a mean (SD) of 94.92 (1.72) vs 86.63 (6.34), respectively (P<0.001). The average time spent by Group B was shorter than that spent by Group A, with a mean (SD) of 17.67 (1.01) vs 21.75 (1.82), respectively (P<0.001). The satisfaction and confidence of Group B were higher than those of Group A (P<0.001).
Conclusion
Compared with repeated video display, combined video display and live demonstration are more suitable training methods for donning and doffing PPE.",2020,"The average score of Group B was higher than that Group A, with a mean (SD) of 94.92 (1.72) vs 86.63 (6.34), respectively","['48 health care workers randomly divided into two groups', 'Healthcare Providers for Donning and Doffing Personal Protective Equipment']",['Repeated Video Display vs Combined Video Display and Live Demonstration'],"['40-minute learning time', 'average time spent']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0469467,"The average score of Group B was higher than that Group A, with a mean (SD) of 94.92 (1.72) vs 86.63 (6.34), respectively","[{'ForeName': 'Yongxing', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhong', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Caineng', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xiaoqiu', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhengyuan', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': ""Department of Anesthesiology, The University of Hong Kong, Hong Kong, People's Republic of China.""}, {'ForeName': 'Wuhua', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.""}]",Risk management and healthcare policy,['10.2147/RMHP.S267514']
2271,33154688,"Effects of Transcutaneous Electrical Acupoint Stimulation on the Postoperative Sleep Quality and Pain of Patients After Video-Assisted Thoracoscopic Surgery: A Prospective, Randomized Controlled Trial.","Objective
Postoperative sleep disturbances have serious adverse effects on postoperative outcomes. Our paper aimed to observe the effect of using transcutaneous electrical acupoint stimulation (TEAS) on sleep quality and complications after surgery in patients undergoing selective video-assisted thoracoscopic surgery.
Patients and Methods
Eighty-five patients were divided into the TEAS group or the control group randomly. Thirty minutes of TEAS treatment was performed on TEAS group at the following time points: the first night before surgery, at the end of surgery, and before sleeping on the second and third nights after surgery. The Portable Sleep Monitor (PSM) was performed to determine the sleep quality of the two nights before the operation (Sleep preop 2 and Sleep preop 1) and the first and third night after surgery (Sleep POD 1 and Sleep POD 3). The visual analog scale (VAS) was performed to evaluate pain scores after surgery and the Athens Insomnia Scale (AIS) was used for evaluating subjective sleep quality.
Results
Participants in the TEAS group had a lower AIS score and higher sleep efficiency at each time point except Sleep preop 2. Participants in the TEAS group showed significantly higher proportion of each sleep stage during Sleep-preop 1, Sleep POD 1, and Sleep POD 3. Patients in the TEAS group had significantly lower VAS scores at 2, 4, and 6 h during the first 24 h after surgery. The incidence of nausea and vomiting and dizziness in the control group was statistically higher than in the TEAS group.
Conclusion
Patients usually have sleep disturbances after video-assisted thoracoscopic surgery, such as decreased distribution of each sleep stage, lower sleep efficiency, and higher AIS score. Undergoing TEAS treatment perioperatively can improve sleep quality, and effectively promote the postoperative analgesic effect and alleviate postoperative complications.",2020,"The incidence of nausea and vomiting and dizziness in the control group was statistically higher than in the TEAS group.
","['patients undergoing selective video-assisted thoracoscopic surgery', 'Patients and Methods\n\n\nEighty-five patients']","['TEAS', 'Transcutaneous Electrical Acupoint Stimulation', 'transcutaneous electrical acupoint stimulation (TEAS', 'Video-Assisted Thoracoscopic Surgery', 'Portable Sleep Monitor (PSM']","['proportion of each sleep stage during Sleep-preop 1, Sleep POD 1, and Sleep POD 3', 'subjective sleep quality', 'nausea and vomiting and dizziness', 'VAS scores', 'visual analog scale (VAS', 'postoperative analgesic effect and alleviate postoperative complications', 'lower AIS score and higher sleep efficiency', 'pain scores', 'sleep quality and complications', 'sleep disturbances', 'Postoperative Sleep Quality and Pain of Patients', 'sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517892', 'cui_str': '85'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1454475', 'cui_str': 'TCF21 protein, human'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",85.0,0.032243,"The incidence of nausea and vomiting and dizziness in the control group was statistically higher than in the TEAS group.
","[{'ForeName': 'Bijia', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': ""Department of Anesthesiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': ""Department of Anesthesiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Junchao', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ""Department of Anesthesiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}]",Nature and science of sleep,['10.2147/NSS.S270739']
2272,33154706,Can We Use Peer-Assisted Learning to Teach Basic Surgical Skills?,"Background
It is reported that medical students do not receive adequate opportunities to learn surgical skill and are at risk of being unable to perform simple surgical procedures safely. The usefulness of peer-assisted learning (PAL) as a tool to assist in delivering surgical skills training is worth exploring.
Methods
This is a randomised single blinded controlled trial. Fourth-year students from the university's Surgical Society were asked to volunteer as peer tutors and those in 3rd-year were asked to undertake surgical skills training. A cohort of 35 students were selected and randomised to receive basic surgical skills training conducted either by faculty members or peers. The students' performance of basic suturing skills was assessed using a checklist, through directly observed procedural skills (DOPS) technique. The assessment was conducted by faculty blinded to the training. Students' perception to surgical skills training was assessed using a questionnaire survey.
Results
The suturing and knotting skills of students learned from their peers was comparable to that acquired from faculty. The students' perceived that their peers could conduct surgical skills training similar to their faculty.
Conclusion
PAL approach for basic surgical skills training is as effective as faculty-led training. PAL has the potential to optimise the delivery of surgical skills training in undergraduate medical education.",2020,"The students' performance of basic suturing skills was assessed using a checklist, through directly observed procedural skills (DOPS) technique.","[""Fourth-year students from the university's Surgical Society were asked to volunteer as peer tutors and those in 3rd-year were asked to undertake surgical skills training"", '35 students']","['peer-assisted learning (PAL', 'basic surgical skills training conducted either by faculty members or peers']",[],"[{'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]",[],35.0,0.0321379,"The students' performance of basic suturing skills was assessed using a checklist, through directly observed procedural skills (DOPS) technique.","[{'ForeName': 'Mang Ning', 'Initials': 'MN', 'LastName': 'Ong', 'Affiliation': 'International Medical University, Seremban, Negeri Sembilan, Malaysia.'}, {'ForeName': 'Kar Min', 'Initials': 'KM', 'LastName': 'Lew', 'Affiliation': 'International Medical University, Seremban, Negeri Sembilan, Malaysia.'}, {'ForeName': 'Yih Jeng', 'Initials': 'YJ', 'LastName': 'Cheong', 'Affiliation': 'International Medical University, Seremban, Negeri Sembilan, Malaysia.'}, {'ForeName': 'Evelyn Wan Xuan', 'Initials': 'EWX', 'LastName': 'Ting', 'Affiliation': 'International Medical University, Seremban, Negeri Sembilan, Malaysia.'}, {'ForeName': 'Bakri', 'Initials': 'B', 'LastName': 'Bohari', 'Affiliation': 'International Medical University, Seremban, Negeri Sembilan, Malaysia.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Yita', 'Affiliation': 'International Medical University, Seremban, Negeri Sembilan, Malaysia.'}, {'ForeName': 'Kandasami', 'Initials': 'K', 'LastName': 'Palayan', 'Affiliation': 'International Medical University, Seremban, Negeri Sembilan, Malaysia.'}]",The Malaysian journal of medical sciences : MJMS,['10.21315/mjms2020.27.5.10']
2273,33154790,Effect of a single initial phase of non-surgical treatment of peri-implantitis: Abrasive air polishing versus ultrasounds. A prospective randomized controlled clinical study.,"Background
Non-surgical treatment of peri-implantitis includes a correct mechanical debridement of the implant surface to reduce the inflammation and recondition the soft tissues. The aim of the study was to evaluate the results of a single phase of non-surgical therapy by comparing the effect of curettes and ultrasounds versus curettes and abrasive air polisher (Air-Flow) in the peri-implant tissue conditions, and patient satisfaction.
Material and Methods
A double-blind randomized and controlled prospective clinical study was conducted on patients in peri-implant maintenance phase diagnosed of peri-implantitis treated in the Oral Surgery Unit of the Stomatology Department of the Faculty of Medicine and Dentistry of the University of Valencia, between September of 2017 and May of 2018. They were divided into 2 groups: Group 1: curettes and ultrasounds, and Group 2: curettes and Air-Flow. The clinical and radiological baseline parameters were evaluated after 3-weeks of treatment, as well as patient satisfaction.
Results
The sample included 34 patients. Group 1 (17 patients, 38 implants) and Group 2 (17 patients, 32 implants). All the variables improved statistically significantly after treatment in both groups, with the exception of recessions and keratinized mucosa and bone loss that did not vary. When comparing both groups, the type of treatment did not influence the majority of the variables, with the exception of the plaque index ( p =0.011) and modified bleeding index from the palatine ( p =0.048), which reduced statistically significant in the group 2, as well as the patient satisfaction which was higher in the group 2 ( p <0.001).
Conclusions
An initial phase of non-surgical treatment achieves an improvement of the peri-implant clinical parameters, thought the method of debridement used seems not to influence. Key words: Peri-implantitis, peri-implant disease, non-surgical treatment, air-abrasive device, mechanical debridement.",2020,"All the variables improved statistically significantly after treatment in both groups, with the exception of recessions and keratinized mucosa and bone loss that did not vary.","['peri-implantitis', 'patients in peri-implant maintenance phase diagnosed of peri-implantitis treated in the Oral Surgery Unit of the Stomatology Department of the Faculty of Medicine and Dentistry of the University of Valencia, between September of 2017 and May of 2018', 'The sample included 34 patients']","['Key words: Peri-implantitis, peri-implant disease, non-surgical treatment, air-abrasive device, mechanical debridement', 'curettes and ultrasounds, and Group 2: curettes and Air-Flow', 'Abrasive air polishing versus ultrasounds', 'curettes and ultrasounds versus curettes and abrasive air polisher (Air-Flow']","['modified bleeding index', 'plaque index', 'recessions and keratinized mucosa and bone loss', 'patient satisfaction']","[{'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0029167', 'cui_str': 'Medicine, Oral'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0180236', 'cui_str': 'Curette'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",34.0,0.0276952,"All the variables improved statistically significantly after treatment in both groups, with the exception of recessions and keratinized mucosa and bone loss that did not vary.","[{'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Aloy-Prósper', 'Affiliation': 'Assistant Professor of Oral Surgery, Stomatology Department, Faculty of Medicine and Dentistry, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Hilario', 'Initials': 'H', 'LastName': 'Pellicer-Chover', 'Affiliation': 'Collaborating Professor of the Master in Oral Surgery and Implant Dentistry, Stomatology Department, Faculty of Medicine and Dentistry, University of Valencia, Valencia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peñarrocha-Oltra', 'Affiliation': 'Doctor Assistant of Oral Surgery, Stomatology Department, Faculty of Medicine and Dentistry, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Peñarrocha-Diago', 'Affiliation': 'Chairman of Oral Surgery, Stomatology Department, Faculty of Medicine and Dentistry, University of Valencia, Valencia, Spain.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.56653']
2274,33154791,Patient compliance to postoperative instructions after third molar surgery comparing traditional verbally and written form versus the effect of a postoperative phone call follow-up a: A randomized clinical study.,"Background
The understanding and adherence to postoperative care instructions may be influenced by how they are presented by the professional interfering the recuperation process after surgery. The aim of this study was to evaluate the effect of a postoperative phone call follow-up compared with a traditional verbally and written instructions regarding compliance of postoperative recommendations after third molar surgery; and secondly, to discover the main points of non-compliance.
Material and Methods
A randomized clinical study was performed including patients that underwent surgical extraction of an impacted mandibular or maxillary third molar in the Oral Surgery Unit of the University of Valencia from January 2016 to January 2017. Patients were randomly assigned to one of three different test groups according to how the post-operative instructions were delivered: brief written instructions, written extended instructions or brief written instructions plus a phone call follow-up at 3-day postoperative period. Patients were interviewed about their adherence to the instructions one week after surgery. The significance level was set at p <0.05.
Results
The higher score of compliance was found to the phone call follow-up group ( p =0.001). No statistically significant differences were found between brief written group and the group that received written extended instructions. In the phone call follow-up group all variables assessed to the compliance were fulfilled. To brief written and written extended instructions groups, the main points of non-compliance were hygiene and smoking ( p <0.001, p =0.026, respectively), and tended towards significance for chlorhexidine rinses and antibiotic, analgesic and anti-inflammatories medication prescribed.
Conclusions
Telephone call follow-up can promote patient adherence to postoperative recommendations after third molar surgery. The main factors of non-compliance were not maintain a proper hygiene and not smoking, followed by not performing chlorhexidine rinses and not following medication prescribed. Key words: Compliance, postoperative instructions, postoperative recommendations, third molar surgery.",2020,The higher score of compliance was found to the phone call follow-up group ( p =0.001).,['patients that underwent surgical extraction of an impacted mandibular or maxillary third molar in the Oral Surgery Unit of the University of Valencia from January 2016 to January 2017'],"['brief written instructions, written extended instructions or brief written instructions plus a phone call follow-up at 3-day postoperative period', 'postoperative phone call follow-up compared with a traditional verbally and written instructions']",['higher score of compliance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1293139', 'cui_str': 'Surgical extraction'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",,0.059797,The higher score of compliance was found to the phone call follow-up group ( p =0.001).,"[{'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Aloy-Prósper', 'Affiliation': 'DDS, PhD. Assistant Professor of Oral Surgery, Stomatology Department, Faculty of Medicine and Dentistry, University of Valencia, Spain.'}, {'ForeName': 'Hilario', 'Initials': 'H', 'LastName': 'Pellicer-Chover', 'Affiliation': 'DDS, PhD. Collaborating Professor of the Master in Oral Surgery and Implant Dentistry, Stomatology Department, Faculty of Medicine and Dentistry, University of Valencia, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Balaguer-Martínez', 'Affiliation': 'DDS, MSc. Student of Master in Oral Surgery and Implant Dentistry, Stomatology Department, Faculty of Medicine and Dentistry, University of Valencia, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Llamas-Monteagudo', 'Affiliation': 'Master in Oral Surgery and Implant Dentistry, Stomatology Department, Faculty of Medicine and Dentistry, University of Valencia, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Peñarrocha-Diago', 'Affiliation': 'MD, PhD. Chairman of Oral Surgery, Stomatology Department, Faculty of Medicine and Dentistry, University of Valencia, Spain.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.56680']
2275,33155057,Green Light Exposure Improves Pain and Quality of Life in Fibromyalgia Patients: A Preliminary One-Way Crossover Clinical Trial.,"OBJECTIVE
Fibromyalgia is a functional pain disorder in which patients suffer from widespread pain and poor quality of life. Fibromyalgia pain and its impact on quality of life are not effectively managed with current therapeutics. Previously, in a preclinical rat study, we demonstrated that exposure to green light-emitting diodes (GLED) for 8 hours/day for 5 days resulted in antinociception and reversal of thermal and mechanical hypersensitivity associated with models of injury-related pain. Given the safety of GLED and the ease of its use, our objective is to administer GLED as a potential therapy to patients with fibromyalgia.
DESIGN
One-way crossover clinical trial.
SETTING
United States.
METHOD
We enrolled 21 adult patients with fibromyalgia recruited from the University of Arizona chronic pain clinic who were initially exposed to white light-emitting diodes and then were crossed over to GLED for 1 to 2 hours daily for 10 weeks. Data were collected by using paper surveys.
RESULTS
When patients were exposed to GLED, but not white light-emitting diodes, they reported a significant reduction in average pain intensity on the 10-point numeric pain scale. Secondary outcomes were assessed by using the EQ-5D-5L survey, Short-Form McGill Pain Questionnaire, and Fibromyalgia Impact Questionnaire and were also significantly improved in patients exposed to GLED. GLED therapy was not associated with any measured side effects in these patients.
CONCLUSION
Although the mechanism by which GLED elicits pain reduction is currently being studied, these results supporting its efficacy and safety merit a larger clinical trial.",2020,"Secondary outcomes were assessed by using the EQ-5D-5L survey, Short-Form McGill Pain Questionnaire, and Fibromyalgia Impact Questionnaire and were also significantly improved in patients exposed to GLED.","['United States', '21 adult patients with fibromyalgia recruited from the University of Arizona chronic pain clinic who were initially exposed to white light-emitting diodes and then were crossed over to', 'Fibromyalgia Patients', 'patients with fibromyalgia']","['GLED', 'Green Light Exposure', 'GLED therapy']","['EQ-5D-5L survey, Short-Form McGill Pain Questionnaire, and Fibromyalgia Impact Questionnaire', 'side effects', '10-point numeric pain scale', 'Fibromyalgia pain', 'quality of life', 'average pain intensity', 'antinociception and reversal of thermal and mechanical hypersensitivity', 'Pain and Quality of Life']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003787', 'cui_str': 'Arizona - US state'}, {'cui': 'C3839654', 'cui_str': 'Chronic pain clinic'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}]","[{'cui': 'C1306567', 'cui_str': 'Green light'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",21.0,0.0995394,"Secondary outcomes were assessed by using the EQ-5D-5L survey, Short-Form McGill Pain Questionnaire, and Fibromyalgia Impact Questionnaire and were also significantly improved in patients exposed to GLED.","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Departments of Pharmacology.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Porreca', 'Affiliation': 'Departments of Pharmacology.'}, {'ForeName': 'Elizabeth I', 'Initials': 'EI', 'LastName': 'Mata', 'Affiliation': 'College of Medicine, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Salloum', 'Affiliation': 'College of Medicine, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Vasudha', 'Initials': 'V', 'LastName': 'Goel', 'Affiliation': 'Department of Anesthesiology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Gunnala', 'Affiliation': 'Departments of Pharmacology.'}, {'ForeName': 'Wiliam D S', 'Initials': 'WDS', 'LastName': 'Killgore', 'Affiliation': 'Psychiatry.'}, {'ForeName': 'Sejal', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Neurology.'}, {'ForeName': 'Felesia N', 'Initials': 'FN', 'LastName': 'Jones-MacFarland', 'Affiliation': 'Neurology.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': 'Departments of Pharmacology.'}, {'ForeName': 'Amol', 'Initials': 'A', 'LastName': 'Patwardhan', 'Affiliation': 'Departments of Pharmacology.'}, {'ForeName': 'Mohab M', 'Initials': 'MM', 'LastName': 'Ibrahim', 'Affiliation': 'Departments of Pharmacology.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa329']
2276,33155090,Superior patient satisfaction in medial pivot as compared to posterior stabilized total knee arthroplasty: a prospective randomized study.,"PURPOSE
Medial pivot (MP) total knee arthroplasty (TKA) aims to restore native knee kinematics due to highly conforming medial tibio-femoral articulation with survival comparable to contemporary knee designs. Posterior stabilized (PS) TKAs use cam-post mechanism to restore native femoral rollback. However, there is conflicting evidence regarding the reported patient satisfaction with MP TKA designs when compared to PS TKAs. The primary aim of this study is to compare the patient satisfaction between MP and PS TKA and the secondary aim is to establish potential reasons behind any differences in the outcomes noted between these two design philosophies.
METHODS
In this IRB-approved single surgeon, single centre prospective RCT, 53 patients (mean age 62 years, 42 women) with comparable bilateral end-stage knee arthritis undergoing simultaneous bilateral TKA were randomized to receive MP TKA in one knee and PS TKA in the contralateral knee. At 4 years post-surgery, all patients were assessed using Knee Society Score (KSS)-Satisfaction and -Expectation scores, and Oxford Knee Score (OKS). In addition, all the patients underwent standardized radiological and in vivo kinematic assessment.
RESULTS
Patients were more satisfied with the MP TKA as compared to PS TKA: mean KSS-Satisfaction [34.5 ± 3.05 in MP and 31.7 ± 3.16 in PS TKAs (p < 0.0001)] and mean KSS-Expectation scores [12.5 ± 1.39 in MP TKAs and 11.2 ± 1.41 in PS TKAs (p < 0.0001)]. No significant difference was noted in any other clinical outcomes. The in vivo kinematics of MP TKAs was significantly better than those of PS TKAs.
CONCLUSION
MP TKAs provide superior patient satisfaction and patient expectations as compared to PS TKA. This may be related to better replication of natural knee kinematics with MP TKA.
LEVEL OF EVIDENCE
I.",2020,"RESULTS
Patients were more satisfied with the MP TKA as compared to PS TKA: mean KSS-Satisfaction [34.5 ± 3.05 in MP and 31.7 ± 3.16 in PS TKAs (p < 0.0001)] and mean KSS-Expectation scores [12.5 ± 1.39 in MP TKAs and 11.2 ± 1.41 in PS TKAs (p < 0.0001)].","['posterior stabilized total knee arthroplasty', '53 patients (mean age 62\xa0years, 42 women) with comparable bilateral end-stage knee arthritis undergoing simultaneous bilateral TKA']","['MP TKA', 'MP TKAs', 'Medial pivot (MP) total knee arthroplasty (TKA']","['Knee Society Score (KSS)-Satisfaction and -Expectation scores, and Oxford Knee Score (OKS', 'mean KSS-Expectation scores']","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0240111', 'cui_str': 'Arthritis of knee'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.195245,"RESULTS
Patients were more satisfied with the MP TKA as compared to PS TKA: mean KSS-Satisfaction [34.5 ± 3.05 in MP and 31.7 ± 3.16 in PS TKAs (p < 0.0001)] and mean KSS-Expectation scores [12.5 ± 1.39 in MP TKAs and 11.2 ± 1.41 in PS TKAs (p < 0.0001)].","[{'ForeName': 'Sahil', 'Initials': 'S', 'LastName': 'Batra', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences (AIIMS), New Delhi, 110029, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences (AIIMS), New Delhi, 110029, India. rmalhotra62@gmail.com.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences (AIIMS), New Delhi, 110029, India.'}, {'ForeName': 'Deep Narayan', 'Initials': 'DN', 'LastName': 'Srivastava', 'Affiliation': 'Department of Radiodiagnosis, All India Institute of Medical Sciences (AIIMS), New Delhi, 110029, India.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Backstein', 'Affiliation': 'Division of Orthopaedics, Granovsky Gluskin Chair in Complex Hip & Knee Reconstruction, Sinai Health System, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Pandit', 'Affiliation': 'Chapel Allerton Hospital, University of Leeds, Leeds, UK.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06343-4']
2277,33155141,Adequate vitamin D supplementation does not ameliorate bone loss following long limb-biliopancreatic diversion in morbidly obese women.,"OBJECTIVES
The objective of this study is to investigate the effect of adequate vitamin D supplementation on bone mineral density (BMD) following long limb-biliopancreatic diversion (LL-BPD), a malabsorptive bariatric operation.
BACKGROUND
Marked weight loss following bariatric surgery is associated with significant decrease in BMD, attributed to the weight loss and to nutritional, mineral, and vitamin D deficiencies resulting in secondary hyperparathyroidism.
METHODS
Two groups, of 35 and 37 healthy, obese (BMI, 50.4 + 6.6 and 46.5 + 4.8 g/cm 2 ), premenopausal, normally menstruating women underwent LL-BPD. Both groups received high-calcium diets, 600 IU of vitamin D, and 1000 mg elemental calcium daily, while group B received an extra dose of vitamin D (10,000 IU/day) during the first postoperative month, followed by dose adjustment in order to maintain 25OHD concentration higher than 30 μg/L. Areal BMD (aBMD) was measured at the lumbar spine preoperatively and 1 year postoperatively.
RESULTS
One year postoperatively, BMI decreased by approximately 19 kg/m 2 in both groups, while 25-OH-vitamin D levels did not change in group A (18.7 + 9.1 to 20.2 + 13.0 μg/L, (p = 0.57)) and increased in group B (15.58 ± 5.73 to 52.97 ± 15.46 μg/L, (p = < 0.001). PTH levels increased in group A (from 38.5 ± 12.2 to 51.2 ± 32.8 pg/ml) (p = 0.047) and decreased in group B (from 51.61 ± 18.7 to 45.1 ± 17.8 pg/ml) (p = 0.042). Lumbar spine aBMD decreased similarly in both groups (p = 0.311, for the comparison between groups) from 1.198 + 0.14 to 1.103 + 0.15 g/cm 2 in group A (p < 0.001) and from 1.157 + 0.14 to 1.076 + 0.14 g/cm 2 in group B (p < 0.001) and Z-score from 0.93 + 0.97 to 0.19 + 1.02, (p < 0.001) and from 1.15 + 1.29 to 0.419 + 1.28, (p < 0.001), respectively.
CONCLUSIONS
LL-BPD leads to similar and significant bone mass reduction 1 year postoperatively, irrespective of adequate vitamin D replacement and in the absence of secondary hyperparathyroidism.",2020,"Lumbar spine aBMD decreased similarly in both groups (p = 0.311, for the comparison between groups) from 1.198 + 0.14 to 1.103 + 0.15 ","['Two groups, of 35 and 37 healthy, obese (BMI, 50.4\xa0+\xa06.6 and 46.5\xa0+\xa04.8\xa0g/cm 2 ), premenopausal, normally menstruating women underwent LL-BPD', 'morbidly obese women']","['vitamin D, and 1000\xa0mg elemental calcium daily, while group B received an extra dose of vitamin D', 'high-calcium diets', 'adequate vitamin D supplementation', 'Adequate vitamin D supplementation']","['BMI', 'bone mineral density (BMD', 'Z-score', '25-OH-vitamin D levels', 'PTH levels', 'Lumbar spine aBMD', 'BMD', 'bone loss']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0005435', 'cui_str': 'Biliopancreatic bypass'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0553702', 'cui_str': 'Ca++ increased'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",,0.172942,"Lumbar spine aBMD decreased similarly in both groups (p = 0.311, for the comparison between groups) from 1.198 + 0.14 to 1.103 + 0.15 ","[{'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Volonakis', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, School of Medicine, University of Patras, 26504, Rio, Greece.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Koika', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, School of Medicine, University of Patras, 26504, Rio, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tzavelas', 'Affiliation': 'Department of Radiology, School of Medicine, University of Patras, 26504, Rio, Greece.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Skopeliti', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, School of Medicine, University of Patras, 26504, Rio, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Skroubis', 'Affiliation': 'Department of Surgery, School of Medicine, University of Patras, 26504, Rio, Greece.'}, {'ForeName': 'Fotis', 'Initials': 'F', 'LastName': 'Kalfarentzos', 'Affiliation': 'Department of Surgery, School of Medicine, University of Patras, 26504, Rio, Greece.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Alexandrides', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, School of Medicine, University of Patras, 26504, Rio, Greece. thalex@med.upatras.gr.'}]","Hormones (Athens, Greece)",['10.1007/s42000-020-00254-2']
2278,33155188,Machine learning prediction on number of patients due to conjunctivitis based on air pollutants: a preliminary study.,"OBJECTIVE
A prediction of the number of patients with conjunctivitis plays an important role in providing adequate treatment at the hospital, but such accurate predictive model currently does not exist. The current study sought to use machine learning (ML) prediction based on past patient for conjunctivitis and several air pollutants. The optimal machine learning prediction model was selected to predict conjunctivitis-related number patients.
PATIENTS AND METHODS
The average daily air pollutants concentrations (CO, O3, NO2, SO2, PM10, PM2.5) and weather data (highest and lowest temperature) were collected. Data were randomly divided into training dataset and test dataset, and normalized mean square error (NMSE) was calculated by 10 fold cross validation, comparing between the ability of seven ML methods to predict the number of patients due to conjunctivitis (Lasso penalized linear model, Decision tree, Boosting regression, Bagging regression, Random forest, Support vector, and Neural network). According to the accuracy of impact prediction, the important air and weather factors that affect conjunctivitis were identified.
RESULTS
A total of 84,977 cases to treat conjunctivitis were obtained from the ophthalmology center of the Affiliated Hospital of Hangzhou Normal University. For all patients together, the NMSE of the different methods were as follows: Lasso penalized linear regression: 0.755, Decision tree: 0.710, Boosting regression: 0.616, Bagging regression: 0.615, Random forest: 0.392, Support vectors: 0.688, and Neural network: 0.476. Further analyses, stratified by gender and age at diagnosis, supported Random forest as being superior to others ML methods. The main factors affecting conjunctivitis were: O3, NO2, SO2 and air temperature.
CONCLUSIONS
Machine learning algorithm can predict the number of patients due to conjunctivitis, among which, the Random forest algorithm had the highest accuracy. Machine learning algorithm could provide accurate information for hospitals dealing with conjunctivitis caused by air factors.",2020,"Further analyses, stratified by gender and age at diagnosis, supported Random forest as being superior to others ML methods.","['past patient for conjunctivitis and several air pollutants', '84,977 cases to treat conjunctivitis were obtained from the ophthalmology center of the Affiliated Hospital of Hangzhou Normal University', 'patients due to conjunctivitis based on air pollutants']","['Machine learning prediction', 'machine learning (ML', 'Machine learning algorithm']","['O3, NO2, SO2 and air temperature', 'average daily air pollutants concentrations (CO, O3, NO2, SO2, PM10, PM2.5) and weather data (highest and lowest temperature']","[{'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}, {'cui': 'C0001869', 'cui_str': 'Air Pollutants'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0038777', 'cui_str': 'Sulfur Dioxide'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001869', 'cui_str': 'Air Pollutants'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0043085', 'cui_str': 'Weather'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}]",84977.0,0.0226673,"Further analyses, stratified by gender and age at diagnosis, supported Random forest as being superior to others ML methods.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Affiliated Hospital of Hangzhou Normal University, Hangzhou, China. wmw990556@163.com.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202010_23380']
2279,33155348,Culturally Adapted Cognitive Behavioral Therapy Plus Problem Management (CA-CBT+) With Afghan Refugees: A Randomized Controlled Pilot Study.,"Culturally adapted cognitive behavioral therapy (CA-CBT) is a well-evaluated, transdiagnostic group intervention for refugees that uses psychoeducation, meditation, and stretching exercises. In the current study, we added problem-solving training to CA-CBT and evaluated this treatment (i.e., CA-CBT+) in a randomized controlled pilot trial with a sample of Farsi-speaking refugees. Participants (N = 24) were male refugees diagnosed with DSM-5 PTSD, major depressive disorder, and anxiety disorders who were randomly assigned to either a treatment or waitlist control (WLC) condition. Treatment components were adapted both to the specific cultural background and the current social problems of asylum seekers. Assessments were performed pretreatment, 12-weeks posttreatment, and 1-year follow-up. The primary treatment outcome was the General Health Questionnaire (GHQ-28); secondary outcome measures included the Posttraumatic Stress Disorder Checklist, Patient Health Questionnaire, Somatic Symptom Scale, World Health Organization Quality of Life, and Emotion Regulation Scale. Eleven of 12 participants were randomized to CA-CBT+ completed treatment. Based on intent-to-treat data, large between-group effect sizes were seen at posttreatment in the GHQ-28, d = 3.0, and for most secondary outcome measures. Improvements for individuals in the treatment group decreased at 1-year follow-up, but effect sizes demonstrated continued large improvements on all measures as compared to pretreatment levels. In summary, CA-CBT+ led to large improvements in general psychopathological distress and quality of life, which were maintained in the long term. In addition, the dropout rate was very low, with delivery in group format. Thus, problem-solving training appears to be a promising addition to CA-CBT.",2020,"Improvements for individuals in the treatment group decreased at 1-year follow-up, but effect sizes demonstrated continued large improvements on all measures as compared to pretreatment levels.","['With Afghan Refugees', 'Participants (N = 24) were male refugees diagnosed with DSM-5 PTSD, major depressive disorder, and anxiety disorders', 'Eleven of 12 participants']","['Culturally adapted cognitive behavioral therapy (CA-CBT', 'waitlist control (WLC) condition', 'CA-CBT', 'Culturally Adapted Cognitive Behavioral Therapy Plus Problem Management (CA-CBT']","['general psychopathological distress and quality of life', 'General Health Questionnaire (GHQ-28', 'dropout rate', 'Posttraumatic Stress Disorder Checklist, Patient Health Questionnaire, Somatic Symptom Scale, World Health Organization Quality of Life, and Emotion Regulation Scale']","[{'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",24.0,0.0340533,"Improvements for individuals in the treatment group decreased at 1-year follow-up, but effect sizes demonstrated continued large improvements on all measures as compared to pretreatment levels.","[{'ForeName': 'Schahryar', 'Initials': 'S', 'LastName': 'Kananian', 'Affiliation': 'Department of Psychology, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Yasaman', 'Initials': 'Y', 'LastName': 'Soltani', 'Affiliation': 'Department of Psychology, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Hinton', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Stangier', 'Affiliation': 'Department of Psychology, University of Frankfurt, Frankfurt, Germany.'}]",Journal of traumatic stress,['10.1002/jts.22615']
2280,33155357,"Elderly patients, isometric exercise, and native vascular access maturation: An unsolved question?","INTRODUCTION
The number of elderly patients undergoing hemodialysis is steadily increasing. The choice and management of vascular access (VA) in these patients are difficult, and the role of postoperative isometric exercises on native VA maturation in the elderly population is not clearly established.
OBJECTIVES
To assess the effect of postoperative isometric exercises on native VA maturation in patients older than 75 years with advanced chronic kidney disease.
METHODOLOGY
This was a randomized single-center study over a 24-month period. Postoperative isometric exercises were performed in the exercise group (EG), while the control group (CG) received usual care. Demographic data, muscle strength (using handgrip [HG] dynamometer), Doppler ultrasound (DUS), incidence of VA complications, and clinical and DUS maturation were assessed at 4 and 8 weeks.
RESULTS
A total of 27 patients were included (EG: 14, CG: 13). The mean age of the patients was 79.9 ± 2.8 years; 74.1% were men, and 59.2% had radiocephalic VA. Demographic data, HG, and DUS measurements were similar at baseline. DUS measurements significantly increased in both groups at the end of the study. A significant increase in HG (19.1 ± 7.8 kg vs. 22.9 ± 9.7 kg, P = 0.001) and the highest clinical (CG vs. EG: 46.2% vs. 78.6%; P = 0.049) and DUS maturation (CG vs. EG: 30.8% vs. 71.4%; P = 0.041) were observed in the EG at 8 weeks. Globally, medical or surgical VA complications were lower in the EG and mainly included significant stenosis (CG vs. EG: 23.1% vs. 7.1%), although no significant differences were observed.
CONCLUSIONS
Once a native VA is indicated in elderly patients, postoperative isometric exercise should be considered in order to improve the odds of achieving a mature functional arteriovenous fistula. Further studies are required to support our findings in this population.",2020,"Postoperative isometric exercises were performed in the exercise group (EG), while the control group (CG) received usual care.","['A total of 27 patients were included (EG: 14, CG: 13', 'elderly patients', 'elderly patients undergoing hemodialysis', 'The mean age of the patients was 79.9\u2009±\u20092.8\u2009years; 74.1% were men, and 59.2% had radiocephalic VA', 'Elderly patients, isometric exercise, and native vascular access maturation', 'patients older than 75\u2009years with advanced chronic kidney disease']","['control group (CG) received usual care', 'Postoperative isometric exercises', 'postoperative isometric exercises']","['HG', 'DUS maturation', 'Demographic data, muscle strength (using handgrip [HG] dynamometer), Doppler ultrasound (DUS), incidence of VA complications, and clinical and DUS maturation', 'DUS measurements', 'medical or surgical VA complications', 'Demographic data, HG, and DUS measurements']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}]","[{'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",27.0,0.0349841,"Postoperative isometric exercises were performed in the exercise group (EG), while the control group (CG) received usual care.","[{'ForeName': 'Irati', 'Initials': 'I', 'LastName': 'Tapia González', 'Affiliation': 'Funtional Unit Vascular Access (FUVA), Nephrology Department, Consorci Sanitari Terrassa (CST), Barcelona, Spain.'}, {'ForeName': 'Vicent', 'Initials': 'V', 'LastName': 'Esteve Simó', 'Affiliation': 'Funtional Unit Vascular Access (FUVA), Nephrology Department, Consorci Sanitari Terrassa (CST), Barcelona, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ibañez', 'Affiliation': 'Funtional Unit Vascular Access (FUVA), Nephrology Department, Consorci Sanitari Terrassa (CST), Barcelona, Spain.'}, {'ForeName': 'Fátima', 'Initials': 'F', 'LastName': 'Moreno Guzman', 'Affiliation': 'Nephrology Department, Consorci Sanitari Terrassa (CST), Barcelona, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Fulquet Nicolás', 'Affiliation': 'Nephrology Department, Consorci Sanitari Terrassa (CST), Barcelona, Spain.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Duarte Gallego', 'Affiliation': 'Nephrology Department, Consorci Sanitari Terrassa (CST), Barcelona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Saurina Solé', 'Affiliation': 'Nephrology Department, Consorci Sanitari Terrassa (CST), Barcelona, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Pou Potau', 'Affiliation': 'Nephrology Department, Consorci Sanitari Terrassa (CST), Barcelona, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Yeste Campos', 'Affiliation': 'Vascular Surgery Department, Consorci Sanitari Terrassa (CST), Barcelona, Spain.'}, {'ForeName': 'Manel Ramírez', 'Initials': 'MR', 'LastName': 'de Arellano Serna', 'Affiliation': 'Nephrology Department, Consorci Sanitari Terrassa (CST), Barcelona, Spain.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12900']
2281,33155422,Clinical comparison of different flap advancement techniques to periosteal releasing incision in guided bone regeneration: A randomized controlled trial.,"OBJECTIVES
To compare Double Flap Incision (DF), Coronally Advanced Lingual Flap (CALF), and Modified Periosteal Releasing Incision (MPRI) to Periosteal Releasing Incision (PRI) in flap advancement, postoperative complications in augmentation using titanium mesh.
MATERIAL AND METHODS
Forty patients with partially edentulous posterior mandibles were randomly assigned to the four groups. We evaluated: (a) Flap advancement in mm (Primary outcome). (b) Pain using the Numerical Rating scale (NRS). (c) Swelling using the Visual Analogue Scale (VAS). (d) Exposure in mm and exposure percentage at 1 week to 6 months.
RESULTS
The CALF showed the highest mean flap advancement of 19.9 (±5.0) mm while the PRI showed the lowest; 10.2 (±1.7) mm. The difference between groups was statistically significant (P value <.0001). MPRI showed the highest pain score of 5.3 (±1.3) while the DF showed the lowest; 2.39 (±1.7). Swelling did not show a significant difference between groups. MPRI showed the highest exposure mean; 18.6 mm (±26.3) while CALF showed the lowest; 2.5 mm (±4.0). PRI showed the highest exposure percentage; 7.4% (±9.3) while CALF showed the lowest; 0.4% (±0.7). The difference between groups was insignificant.
CONCLUSIONS
CALF reported highest advancement, least complications while PRI reported the highest complications.",2020,MPRI showed the highest pain score of 5.3 (±1.3) while the DF showed the lowest; 2.39 (±1.7).,"['Forty patients with partially edentulous posterior mandibles', 'guided bone regeneration']","['Double Flap Incision (DF), Coronally Advanced Lingual Flap (CALF), and Modified Periosteal Releasing Incision (MPRI) to Periosteal Releasing Incision (PRI', 'flap advancement techniques to periosteal releasing incision']","['c) Swelling using the Visual Analogue Scale (VAS', 'b) Pain using the Numerical Rating scale (NRS', 'highest pain score', 'highest mean flap advancement', 'Swelling']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0185157', 'cui_str': 'Release of periosteum'}, {'cui': 'C0442033', 'cui_str': 'Periosteal'}, {'cui': 'C0730463', 'cui_str': 'Advancement technique'}]","[{'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}]",40.0,0.103144,MPRI showed the highest pain score of 5.3 (±1.3) while the DF showed the lowest; 2.39 (±1.7).,"[{'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Zazou', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Diab', 'Affiliation': 'Faculty of Dentistry, Department of Implantology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Samah', 'Initials': 'S', 'LastName': 'Bahaa', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Azza Ezz', 'Initials': 'AE', 'LastName': 'El Arab', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Omniya Abdel', 'Initials': 'OA', 'LastName': 'Aziz', 'Affiliation': 'Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'El Nahass', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Cairo University, Cairo, Egypt.'}]",Clinical implant dentistry and related research,['10.1111/cid.12960']
2282,33155461,Comparison of analgesic efficacy of acetaminophen monotherapy versus acetaminophen combinations with either pethidine or parecoxib in patients undergoing laparoscopic cholecystectomy: a randomized prospective study.,"Aim To investigate analgesic effect of three different regimens of combination of analgesics administered to patients undergoing laparoscopic cholecystectomy. Methods Patients undergoing laparoscopic cholecystectomy were randomly allocated to one of three groups on admission, depending of a prescribed post-operative analgesic regimen. Patients allocated to the group A received a combination of intravenous (IV) acetaminophen and intramuscular (IM) pethidine, patients in the group B received a combination of IV acetaminophen and IV parecoxib, and the patients of the group C received IV acetaminophen monotherapy. Analgesic therapy was administered at regular intervals. Pain was evaluated utilizing the numeric rating scale (NRS) at 5 time points: the first assessment was done at 45 minutes, the second, third, fourth and fifth at 2, 6, 12, and 24 hours post-administration, respectively. Postoperative pain intensity was measured by NRS within the groups and between the groups at each time they analysed using one-way repeat measured ANOVA and Post Hoc Test-Bonferroni Correlation. Results A total of 316 patients were enrolled. The analgesic regimens of groups A and B (combination regimens consisting of IV acetaminophen and intramuscular pethidine and IV acetaminophen and IV parecoxib, respectively) were found to be of equivalent efficacy (p=1.000). In contrast, patients in group C (acetaminophen monotherapy) had higher NRS scores, compared to both patients in groups A (p<0.01) and B (p<0.01). Conclusion This study confirms the notion of a significant opioid-sparing effect of parecoxib in postoperative pain management after laparoscopic cholecystectomy.",2021,"In contrast, patients in group C (acetaminophen monotherapy) had higher NRS scores, compared to both patients in groups A (p<0.01) and B (p<0.01).","['316 patients were enrolled', 'patients undergoing laparoscopic cholecystectomy', 'postoperative pain management after laparoscopic cholecystectomy', 'Methods Patients undergoing laparoscopic cholecystectomy']","['pethidine or parecoxib', 'intravenous (IV) acetaminophen and intramuscular (IM) pethidine', 'acetaminophen and IV parecoxib', 'Analgesic therapy', 'acetaminophen and intramuscular pethidine and IV acetaminophen and IV parecoxib', 'acetaminophen monotherapy versus acetaminophen', 'acetaminophen monotherapy', 'parecoxib']","['numeric rating scale (NRS', 'analgesic effect', 'NRS scores', 'Pain', 'Postoperative pain intensity', 'analgesic efficacy']","[{'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0412784', 'cui_str': 'Analgesic technique'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",316.0,0.0369754,"In contrast, patients in group C (acetaminophen monotherapy) had higher NRS scores, compared to both patients in groups A (p<0.01) and B (p<0.01).","[{'ForeName': 'Francesk', 'Initials': 'F', 'LastName': 'Mulita', 'Affiliation': 'Department of General Surgery, University General Hospital, Patras, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Karpetas', 'Affiliation': 'Department of Anaesthesiology, University General Hospital, Patras, Greece.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Liolis', 'Affiliation': 'Department of Internal Medicine, University General Hospital, Patras, Greece.'}, {'ForeName': 'Michail', 'Initials': 'M', 'LastName': 'Vailas', 'Affiliation': 'Department of General Surgery, University General Hospital, Patras, Greece.'}, {'ForeName': 'Levan', 'Initials': 'L', 'LastName': 'Tchabashvili', 'Affiliation': 'Department of General Surgery, University General Hospital, Patras, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Maroulis', 'Affiliation': 'Department of General Surgery, University General Hospital, Patras, Greece.'}]","Medicinski glasnik : official publication of the Medical Association of Zenica-Doboj Canton, Bosnia and Herzegovina",['10.17392/1245-21']
2283,33159422,"Effects of resistance exercise on complications, cancer-related fatigue and quality of life in nasopharyngeal carcinoma patients undergoing chemoradiotherapy: A randomised controlled trial.","BACKGROUND
Chemotherapy of nasopharyngeal carcinoma (NPC) can lead to significant side effects and complications. Exercises during chemoradiotherapy have potential to reduce complications and fatigue and improve quality of life. The aim of the randomised clinical study was to investigate the benefits of resistance exercise during chemoradiotherapy in NPC patients.
METHODS
A total of 146 patients were randomised to perform resistance or relaxation exercises during chemoradiotherapy. Resistance exercise consisted of eight machine-based progressive resistance exercises, and relaxation control consisted of progressive muscle relaxation. Side effects and complications were analysed, and fatigue was assessed by Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) scores. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ30) scale was used to evaluate the effects of resistance exercise or relaxation control on quality of life. Per-protocol analysis was performed on the collected data.
RESULTS
Resistance exercise has stronger effects than relaxation in reducing complications, including oral mucositis, mouth-opening difficulties, xerostomia, hearing loss and nasal congestion, and alleviating both physical fatigue and mental fatigue. The improvement in quality of life was also more prominent among patients performing resistance exercise.
CONCLUSIONS
For NPC patients undergoing chemoradiotherapy, resistance exercise has a better efficacy in reducing complications, alleviating fatigue and improving quality of life.",2020,"CONCLUSIONS
For NPC patients undergoing chemoradiotherapy","['NPC patients', 'nasopharyngeal carcinoma patients undergoing', 'nasopharyngeal carcinoma (NPC', 'NPC patients undergoing', '146 patients']","['resistance exercise', 'chemoradiotherapy', 'resistance exercise during chemoradiotherapy', 'resistance or relaxation exercises during chemoradiotherapy', 'Resistance exercise consisted of eight machine-based progressive resistance exercises, and relaxation control consisted of progressive muscle relaxation']","['Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ30) scale', 'complications, cancer-related fatigue and quality of life', 'complications and fatigue and improve quality of life', 'complications, including oral mucositis, mouth-opening difficulties, xerostomia, hearing loss and nasal congestion, and alleviating both physical fatigue and mental fatigue', 'Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) scores', 'complications, alleviating fatigue and improving quality of life', 'quality of life']","[{'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0203993', 'cui_str': 'Relaxation exercise'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",146.0,0.205046,"CONCLUSIONS
For NPC patients undergoing chemoradiotherapy","[{'ForeName': 'Qinglei', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': ""Department of Otolaryngology, Wuxi No.2 People's Hospital, Jiangsu, China.""}, {'ForeName': 'Dongju', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': ""Department of Otolaryngology, Wuxi No.2 People's Hospital, Jiangsu, China.""}]",European journal of cancer care,['10.1111/ecc.13355']
2284,33159496,Comparative biomarkers for HBsAg loss with antiviral therapy shows dominant influence of quantitative HBsAg (qHBsAg).,"BACKGROUND
Biomarkers such as quantitative HBsAg (qHBsAg), quantitative hepatitis B virus (HBV) core-related antigen (qHBcrAg) and HBV RNA may be useful in predicting HBsAg loss in patients with chronic hepatitis B (CHB) undergoing antiviral therapy.
AIM(S)
Our study evaluated qHBsAg, HBV RNA and qHBcrAg as a posthoc analysis of a randomized clinical trial of peginterferon±NA to determine their utility in predicting HBsAg loss.
METHODS
CHB patients who completed therapy with 48weeks peginterferon alpha2b ± nucleoside analogue therapy (clinicaltrial.gov NCT01928511) were evaluated at week 72 for HBsAg loss. The predictive ability of qHBsAg, qHBcrAg, HBV RNA and other variables were investigated by univariate and multivariate logistic models for HBeAg-negative patients by odds ratios, area under the curve (AUC), sensitivity, specificity, and positive and negative likelihood ratios (LR).
RESULTS
HBsAg loss occurred in 15/114(13%) HBeAg-negative CHB patients who completed 48 weeks of peginterferon. At baseline, qHBsAg was superior to HBcrAg and HBV RNA with AUC 0.916, 0.649 and 0.542, respectively. Using multivariate analysis, the model comprising treatmentarm, age, gender, baseline qHBsAg, HBcrAg and HBV RNA, weeks 4 & 8 qHBsAg had the highest AUC(0.98), but the univariate model with week 8 qHBsAg <70 IU/mL had AUC 0.96. Hence, the contributions of variables other than qHBsAg were marginal. HBV RNA and qHBcrAg were weak predictors of HBsAg loss. Kinetics of the novel markers showed only qHBsAg had a good relationship with HBsAg loss while HBV RNA had a marginal relationship and HBcrAg did not change at all, and none had a good relationship with viral rebound.
CONCLUSIONS
On-treatment biomarker predictors were better than baseline ones, and the best predictor of HBsAg loss at 72 weeks was week 8 qHBsAg <70 IU/mL.",2020,"At baseline, qHBsAg was superior to HBcrAg and HBV RNA with AUC 0.916, 0.649 and 0.542, respectively.","['CHB patients who completed therapy with 48weeks peginterferon alpha2b\xa0±\xa0nucleoside analogue therapy (clinicaltrial.gov NCT01928511) were evaluated at week 72 for HBsAg loss', 'patients with chronic hepatitis B (CHB) undergoing antiviral therapy']",['peginterferon'],"['predictive ability of qHBsAg, qHBcrAg, HBV RNA', 'area under the curve (AUC), sensitivity, specificity, and positive and negative likelihood ratios (LR', 'quantitative HBsAg (qHBsAg', 'HBsAg loss']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside analog'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}]",[],"[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.052194,"At baseline, qHBsAg was superior to HBcrAg and HBV RNA with AUC 0.916, 0.649 and 0.542, respectively.","[{'ForeName': 'Seng Gee', 'Initials': 'SG', 'LastName': 'Lim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Wah Wah', 'Initials': 'WW', 'LastName': 'Phyo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Joanna Zhi Jie', 'Initials': 'JZJ', 'LastName': 'Ling', 'Affiliation': 'Singapore Clinical Research Institute, Singapore.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Cloherty', 'Affiliation': 'Abbott Laboratories, Abbott Park, IL, USA.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Butler', 'Affiliation': 'Abbott Laboratories, Abbott Park, IL, USA.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Kuhns', 'Affiliation': 'Abbott Laboratories, Abbott Park, IL, USA.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'McNamara', 'Affiliation': 'Abbott Laboratories, Abbott Park, IL, USA.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Holzmayer', 'Affiliation': 'Abbott Laboratories, Abbott Park, IL, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gersch', 'Affiliation': 'Abbott Laboratories, Abbott Park, IL, USA.'}, {'ForeName': 'Wei Lyn', 'Initials': 'WL', 'LastName': 'Yang', 'Affiliation': 'Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Jing Hieng', 'Initials': 'JH', 'LastName': 'Ngu', 'Affiliation': 'Singapore General Hospital, Singapore.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Singapore General Hospital, Singapore.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Taufique', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Khoo Teck Puat Hospital, Singapore.'}, {'ForeName': 'Yock Young', 'Initials': 'YY', 'LastName': 'Dan', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Yin Mei', 'Initials': 'YM', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Guan Huei', 'Initials': 'GH', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Poh Seng', 'Initials': 'PS', 'LastName': 'Tan', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Daniel Q', 'Initials': 'DQ', 'LastName': 'Huang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Htet Toe Wai', 'Initials': 'HTW', 'LastName': 'Khine', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Tay', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Chan', 'Affiliation': 'Singapore Clinical Research Institute, Singapore.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16149']
2285,33159523,Phase-locked Auditory Stimulation of Theta Oscillations during Rapid Eye Movement Sleep.,"Auditory closed-loop stimulation is a non-invasive technique that has been widely used to augment slow oscillations during non-rapid eye movement sleep. Based on the principles of closed-loop stimulation, we developed a novel protocol for manipulating theta activity (3-7 Hz) in rapid eye movement (REM) sleep. Sixteen healthy young adults were studied in two overnight conditions: Stimulation and Sham. In the Stimulation condition, 1 s of 5 Hz amplitude-modulated white noise was delivered upon detection of two supra-threshold theta cycles throughout REM sleep. In the Sham condition, corresponding time points were marked but no stimulation was delivered. Auditory stimulation entrained EEG activity to 5 Hz and evoked a brief (~0.5 s) increase in theta power. Interestingly, this initial theta surge was immediately followed by a prolonged (~3 s) period of theta suppression. Stimulation also induced a prolonged (~2 s) increase in beta power. Our results provide the first demonstration that the REM sleep theta rhythm can be manipulated in a targeted manner via auditory stimulation. Accordingly, auditory stimulation might offer a fruitful avenue for investigating REM sleep electrophysiology and its relationship to behaviour.",2020,Auditory stimulation entrained EEG activity to 5 Hz and evoked a brief (~0.5 s) increase in theta power.,['Sixteen healthy young adults'],['Auditory closed-loop stimulation'],['beta power'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0330390', 'cui_str': 'Beta'}]",16.0,0.0496906,Auditory stimulation entrained EEG activity to 5 Hz and evoked a brief (~0.5 s) increase in theta power.,"[{'ForeName': 'Marcus O', 'Initials': 'MO', 'LastName': 'Harrington', 'Affiliation': 'Department of Psychology, University of York, Heslington, York, UK.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Ashton', 'Affiliation': 'Department of Psychology, University of York, Heslington, York, UK.'}, {'ForeName': 'Hong-Viet V', 'Initials': 'HV', 'LastName': 'Ngo', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboudumc, Netherlands.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Cairney', 'Affiliation': 'Department of Psychology, University of York, Heslington, York, UK.'}]",Sleep,['10.1093/sleep/zsaa227']
2286,33155041,High Thoracic Erector Spinae Plane Block for Arthroscopic Shoulder Surgery: A Randomized Prospective Double-Blind Study.,"OBJECTIVE
Moderate to severe pain may occur following arthroscopic shoulder surgery. An erector spinae plane block (ESPB) may be used for painful conditions of the shoulder. The primary hypothesis of this trial is that ultrasound-guided ESPB would provide effective analgesia by reducing opioid consumption. The secondary hypothesis is that ESPB would result in low pain scores and reduce the use of rescue analgesia.
DESIGN
Randomized prospective double-blind study.
SETTING
Academic university hospital.
SUBJECTS
Sixty patients aged between 18 and 65 years designated as American Society of Anesthesiologists (ASA) class I or II who underwent unilateral arthroscopic shoulder surgery under general anesthesia were included in the study.
METHODS
Patients were equally divided into two groups-either the ESPB group (n=30) or the sham block group (n=30). ESPB was performed with 30 mL 0.25% bupivacaine at the T2 level in the ESPB group and sham block with 30 mL saline at the T2 level in the sham block group. Twenty minutes before the end of the operation, 100 mg tramadol was administered intravenously to the patients. Intravenous ibuprofen 400 mg 3 × 1 was ordered for the patients during the postoperative period. A patient control analgesia device including a dose of 10 µg/mL fentanyl was connected to the patients.
RESULTS
There were no statistical differences between groups in terms of demographical data. Postoperative fentanyl consumption was significantly lower in the ESPB group than in the sham block group (96.66 µg ±105.57 µg and 230 µg ±247.17 µg, respectively) (P=0.009). The need for rescue analgesia was significantly lower in the ESPB group than in the sham block group (26.66 mg ±35.43 mg and 48.5 mg ±35.45 mg, respectively) (P=0.020). Overall, the visual analog scale scores were significantly lower in the ESPB group than in the sham block group.
CONCLUSIONS
ESPB may provide effective analgesia treatment following arthroscopic shoulder surgery.",2020,"The need for rescue analgesia was significantly lower in the ESPB group than in the sham block group (26.66 mg ±35.43 mg and 48.5 mg ±35.45 mg, respectively)","['Patients', 'Sixty patients aged between 18 and 65\xa0years designated as American Society of Anesthesiologists (ASA) class', 'I or II who underwent unilateral arthroscopic shoulder surgery under general anesthesia were included in the study', 'Academic university hospital', 'Arthroscopic Shoulder Surgery']","['bupivacaine', 'Intravenous ibuprofen', 'High Thoracic Erector Spinae Plane Block', 'arthroscopic shoulder surgery', 'tramadol', '10\xa0µg/mL fentanyl', 'ultrasound-guided ESPB', 'ESPB']","['Postoperative fentanyl consumption', 'low pain scores', 'visual analog scale scores', 'need for rescue analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",60.0,0.249174,"The need for rescue analgesia was significantly lower in the ESPB group than in the sham block group (26.66 mg ±35.43 mg and 48.5 mg ±35.45 mg, respectively)","[{'ForeName': 'Bahadir', 'Initials': 'B', 'LastName': 'Ciftci', 'Affiliation': 'Department of Anesthesiology, Istanbul Medipol University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mursel', 'Initials': 'M', 'LastName': 'Ekinci', 'Affiliation': 'Department of Anesthesiology, Istanbul Medipol University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Birzat Emre', 'Initials': 'BE', 'LastName': 'Gölboyu', 'Affiliation': 'Department of Algology, Manisa State Hospital, Manisa, Turkey.'}, {'ForeName': 'Furkan', 'Initials': 'F', 'LastName': 'Kapukaya', 'Affiliation': 'Department of Anesthesiology, Istanbul Medipol University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Yunus Oktay', 'Initials': 'YO', 'LastName': 'Atalay', 'Affiliation': 'Department of Anesthesiology, Istanbul Medipol University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Ersin', 'Initials': 'E', 'LastName': 'Kuyucu', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul Medipol University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Demiraran', 'Affiliation': 'Department of Anesthesiology, Istanbul Medipol University, School of Medicine, Istanbul, Turkey.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa359']
2287,33155236,Effects of individualized antiplatelet therapy based on CYP2C19 genotype and platelet function on the prognosis of patients after PCI.,"OBJECTIVE
To evaluate the effect of individualized antiplatelet therapy based on CYP2C19 genotype and platelet function on the prognosis of patients after percutaneous coronary intervention (PCI) compared with conventional antiplatelet therapy.
PATIENTS AND METHODS
Patients diagnosed with acute coronary syndromes (ACS) in Shandong Provincial Qianfoshan Hospital from December 2014 to December 2017 were included in this prospective study and randomly divided into conventional (CA) and individualized antiplatelet therapy group (IA) at 1:1 ratio. Patients in the CA group received clopidogrel 75 mg once a day (QD). Group IA was divided into extensive, intermediate, and poor metabolizers according to the results of the CYP2C19 gene test. Three genotypes were given clopidogrel 75 mg QD, 75 mg twice daily (BID) and ticagrelor 90 mg BID respectively. After taking these medicines for a period of time, platelet function was monitored by thromboelastography (TEG) and MAADP values were recorded. MAADP indicates the adenosine diphosphate (ADP) induced platelet function that not inhibited by medicine. High platelet reactivity (HPR) was defined as MAADP > 47mm, indicating a high risk of thrombus, and MAADP ≤ 31 mm indicates a high risk of hemorrhage. For extensive metabolizers (EMs) and intermediate metabolizers (IMs) patients with HPR, the antiplatelet therapy would be changed by the clinician according to the patient's conditions. Major adverse cardiovascular events (MACE) and hemorrhage events were monitored during 1-year follow-up.
RESULTS
The patients with MAADP > 47 mm were 89 (28.6%) in the IA group. There were 50 EMs patients with MAADP > 47 mm (33.3%). Of which, there were 2 cases which changed the dosage of clopidogrel to 75 mg BID, 14 cases who changed clopidogrel to ticagrelor. There were 36 IMs patients with MAADP > 47 mm (30.8%). Of which, there were 19 cases who changed clopidogrel to ticagrelor. There was no significant difference in the value of MAADP between EMs and IMs patients. Within 1 year after PCI, the occurrence of MACE in the IA group was significantly lower than that in the CA group (p=0.010).
CONCLUSIONS
(1) Patients with a CYP2C19 loss-of-function (LOF) gene who take double doses of clopidogrel overcome the decreased efficacy of clopidogrel which partly due to CYP2C19 LOF gene, without increasing the risk of hemorrhage. (2) Individualized antiplatelet therapy based on CYP2C19 genotype and platelet function can significantly reduce the occurrence of MACE (mainly acute non-fatal myocardial infarction) after PCI without increasing the risk of moderate or severe hemorrhage.",2020,"Within 1 year after PCI, the occurrence of MACE in the IA group was significantly lower than that in the CA group (p=0.010).
","['For extensive metabolizers (EMs) and intermediate metabolizers (IMs) patients with HPR', 'patients after percutaneous coronary intervention (PCI', 'patients after PCI', 'Patients diagnosed with acute coronary syndromes (ACS) in Shandong Provincial Qianfoshan Hospital from December 2014 to December 2017']","['conventional (CA) and individualized antiplatelet therapy', 'clopidogrel 75 mg QD', 'conventional antiplatelet therapy', 'individualized antiplatelet therapy', 'clopidogrel', 'ticagrelor', 'CA', 'MAADP']","['High platelet reactivity (HPR', 'thromboelastography (TEG) and MAADP values', 'Major adverse cardiovascular events (MACE) and hemorrhage events', 'value of MAADP', 'occurrence of MACE']","[{'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1124675', 'cui_str': 'clopidogrel 75 MG'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",3.0,0.0178191,"Within 1 year after PCI, the occurrence of MACE in the IA group was significantly lower than that in the CA group (p=0.010).
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Jinan, Shandong, China. gaomei0217@163.com.'}, {'ForeName': 'J-R', 'Initials': 'JR', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'M-Y', 'Initials': 'MY', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'X-M', 'Initials': 'XM', 'LastName': 'Jia', 'Affiliation': ''}, {'ForeName': 'L-P', 'Initials': 'LP', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Y-L', 'Initials': 'YL', 'LastName': 'Hou', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202010_23436']
2288,33155295,Impact of exercise training and supplemental oxygen on submaximal exercise performance in patients with COPD.,"Functional impairment caused by chronic obstructive pulmonary disease (COPD) impacts on activities of daily living and quality of life. Indeed, patients' submaximal exercise capacity is of crucial importance. It was the aim of this study to investigate the effects of an exercise training intervention with and without supplemental oxygen on submaximal exercise performance. This is a secondary analysis of a randomized, controlled, double-blind, crossover trial. 29 COPD patients (63.5±5.9 years; FEV 1 46.4±8.6%) completed two consecutive 6-week periods of high intensity interval cycling and strength training, which was performed three times/week with either supplemental oxygen or medical air (10 L/min). Submaximal exercise capacity as well as the cardiocirculatory, ventilatory and metabolic response were evaluated at isotime (point of termination in the shortest cardiopulmonary exercise test), at physical work capacity at 110 bpm of heart rate (PWC 110), at the anaerobic threshold (AT), and at the lactate-2 mmol/L threshold. After 12 weeks of exercise training, patients improved in exercise tolerance, shown by decreased cardiocirculatory (heart rate, blood pressure) and metabolic (respiratory exchange ratio, lactate) effort at isotime; ventilatory response was not affected. Submaximal exercise capacity was improved at PWC 110, AT and the lactate-2 mmol/L threshold, respectively. Although supplemental oxygen seems to affect patients' work rate at AT and the lactate-2 mmol/L threshold, no other significant effects were found. The improved submaximal exercise capacity and tolerance might counteract patients' functional impairment. Although cardiovascular and metabolic training adaptations were shown, ventilatory efficiency remained essentially unchanged. The impact of supplemental oxygen seems less important on submaximal training effects.",2020,"Submaximal exercise capacity was improved at PWC 110, AT and the lactate-2 mmol/L threshold, respectively.","['chronic obstructive pulmonary disease (COPD', 'patients with COPD', '29 COPD patients (63.5±5.9 years; FEV 1 46.4±8.6%) completed two consecutive 6-week periods of']","['supplemental oxygen or medical air', 'exercise training', 'exercise training intervention', 'exercise training and supplemental oxygen', 'high intensity interval cycling and strength training']","['cardiocirculatory (heart rate, blood pressure) and metabolic (respiratory exchange ratio, lactate) effort at isotime; ventilatory response', 'activities of daily living and quality of life', 'cardiocirculatory, ventilatory and metabolic response', 'submaximal exercise performance', 'submaximal exercise capacity and tolerance', 'Submaximal exercise capacity', 'ventilatory efficiency']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3536832', 'cui_str': 'Air'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",29.0,0.0565953,"Submaximal exercise capacity was improved at PWC 110, AT and the lactate-2 mmol/L threshold, respectively.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Neunhäuserer', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University Salzburg, Lindhofstraße 20, 5020, Salzburg, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Reich', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University Salzburg, Lindhofstraße 20, 5020, Salzburg, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mayr', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University Salzburg, Lindhofstraße 20, 5020, Salzburg, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Kaiser', 'Affiliation': 'University Clinic of Pneumology, Paracelsus Medical University Salzburg, Müllner Hauptstraße 48, 5020, Salzburg, Austria.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Lamprecht', 'Affiliation': 'University Clinic of Pneumology, Paracelsus Medical University Salzburg, Müllner Hauptstraße 48, 5020, Salzburg, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Niederseer', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University Salzburg, Lindhofstraße 20, 5020, Salzburg, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ermolao', 'Affiliation': 'Sport and Exercise Medicine Division, Department of Medicine, University of Padova, Via Giustiniani 2, 35128, Padova, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Studnicka', 'Affiliation': 'University Clinic of Pneumology, Paracelsus Medical University Salzburg, Müllner Hauptstraße 48, 5020, Salzburg, Austria.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University Salzburg, Lindhofstraße 20, 5020, Salzburg, Austria.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13870']
2289,33155305,Multicomponent Intervention and Long-Term Disability in Older Adults: A Nonrandomized Prospective Study.,"BACKGROUND/OBJECTIVES
To evaluate the long-term association between a multicomponent intervention program and disability in socioeconomically vulnerable older adults.
DESIGN
This was a nonrandomized prospective intervention trial.
SETTING
The setting was a community.
PARTICIPANTS
Participants included older Koreans living alone or receiving government assistance from a low-income program.
INTERVENTION
The intervention was a 24-week multicomponent program compromising group exercise, nutritional supplementation, management of depression, deprescribing, and home hazard reduction (n = 187) versus usual care (n = 196).
MEASUREMENTS
The number of dependencies in 17 basic and instrumental activities of daily living was measured every 3 months for 30 months (range: 0-17; greater values indicated worse disability). Inverse probability weighting Poisson regression was used to model the number of dependencies to adjust for confounding bias and higher dropout rates of those with greater disability.
RESULTS
The study population had a mean age of 76 years, and 26% were men. During the 30-month follow up, 17 died (n = 8, intervention; n = 9, control), 62 (n = 16, intervention; n = 46, control) were institutionalized or received nursing home care, and 34 (n = 15, intervention; n = 19, control) were lost to follow up. After inverse probability weighting, the mean number of dependencies at baseline was 1.21 and 1.29 for the intervention group and the control group, respectively (P = .80). The intervention group had fewer dependencies than the control group, but the difference was attenuated over time: 1.08 versus 1.60 at 6 months (P = .04), 1.29 versus 1.87 at 12 months (P = .03), 1.62 versus 2.17 at 18 months (P = .06), 2.08 versus 2.51 at 24 months (P = .18), and 2.73 versus 2.90 at 30 months (P = .67).
CONCLUSION
A 24-week multicomponent intervention was associated with a slower progression of disability; however, the diminishing association from 24 months and beyond suggests that reassessment and intervention may be necessary. Due to a lack of randomization, our findings should be interpreted with caution.",2020,"The intervention group had fewer dependencies than the control group, but the difference was attenuated over time: 1.08 versus 1.60 at 6 months (P = .04), 1.29 versus 1.87 at 12 months (P = .03), 1.62 versus 2.17 at 18 months (P = .06), 2.08 versus 2.51 at 24 months (P = .18), and 2.73 versus 2.90 at 30 months (P = .67).
","['The study population had a mean age of 76\u2009years, and 26% were men', 'Older Adults', 'Participants included older Koreans living alone or receiving government assistance from a low-income program', 'socioeconomically vulnerable older adults']","['Multicomponent Intervention', 'multicomponent intervention program', 'multicomponent program compromising group exercise, nutritional supplementation, management of depression, deprescribing, and home hazard reduction (n = 187) versus usual care']","['mean number of dependencies', 'disability', 'slower progression of disability', 'number of dependencies in 17 basic and instrumental activities of daily living']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0439044', 'cui_str': 'Lives alone'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4517618', 'cui_str': '187'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}]",196.0,0.0345739,"The intervention group had fewer dependencies than the control group, but the difference was attenuated over time: 1.08 versus 1.60 at 6 months (P = .04), 1.29 versus 1.87 at 12 months (P = .03), 1.62 versus 2.17 at 18 months (P = .06), 2.08 versus 2.51 at 24 months (P = .18), and 2.73 versus 2.90 at 30 months (P = .67).
","[{'ForeName': 'Chan Mi', 'Initials': 'CM', 'LastName': 'Park', 'Affiliation': 'Department of Family Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Gahee', 'Initials': 'G', 'LastName': 'Oh', 'Affiliation': 'Hebrew SeniorLife, Marcus Institute for Aging Research, Boston, Massachusetts, USA.'}, {'ForeName': 'Heayon', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hee-Won', 'Initials': 'HW', 'LastName': 'Jung', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Eunju', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Il-Young', 'Initials': 'IY', 'LastName': 'Jang', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dae Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Hebrew SeniorLife, Marcus Institute for Aging Research, Boston, Massachusetts, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16926']
2290,33155571,"EatSmart, a Web-Based and Mobile Healthy Eating Intervention for Disadvantaged People With Type 2 Diabetes: Protocol for a Pilot Mixed Methods Intervention Study.","BACKGROUND
People of low socioeconomic position (SEP) are disproportionately affected by type 2 diabetes (T2D), partly due to unhealthy eating patterns that contribute to inadequate disease self-management and prognosis. Digital technologies have the potential to provide a suitable medium to facilitate diabetes education, support self-management, and address some of the barriers to healthy eating, such as lack of nutritional knowledge or shopping or cooking skills, in this target group.
OBJECTIVE
This study aims to test the feasibility, appeal, and potential effectiveness of EatSmart, a 12-week, evidence-based, theoretically grounded, fully automated web-based and mobile-delivered healthy eating behavior change program to help disadvantaged people living with T2D to eat healthily on a budget and improve diabetes self-management.
METHODS
EatSmart is a mixed methods (quantitative and qualitative) pre-post design pilot study. Sixty socioeconomically disadvantaged people with T2D aged 18 to 75 years will be recruited. Participants will complete self-reported baseline assessments of their basic demographic and clinical data, dietary intake, dietary self-efficacy, and barriers to healthy eating. They will be provided with login access to the EatSmart web program, which includes six progressive skill-based modules covering healthy eating planning; smart food budgeting and shopping; time-saving meal strategies, healthy cooking methods, modifying recipes; and a final reinforcement and summary module. Over the 3-month intervention, participants will also receive 3 text messages weekly, encouraging them to review goals, continue to engage with different components of the EatSmart web program, and eat healthily. Participants will undertake follow-up assessments directly following the intervention 3 months post baseline and again after a 6-month postintervention follow-up period (9 months post baseline). Feasibility will be evaluated using the number of participants recruited and retained and objective indicators of engagement with the website. Program appeal and potential effects on primary and secondary outcomes will be assessed via the same surveys used at baseline, with additional questions asking about experience with and perceptions of the program. In-depth qualitative interviews will also be conducted 6 months post intervention to provide deeper insight into experiences with EatSmart and a more comprehensive description of the program's appeal.
RESULTS
The EatSmart website has been developed, and all participants have viewed the modules as of May 2020. Results are expected to be submitted for publication in December 2020.
CONCLUSIONS
This study will provide data to address the currently limited evidence regarding whether disadvantaged populations with T2D may benefit from digitally delivered behavior change programs that facilitate eating healthily on a budget.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry, ACTRN12619001111167; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619001111167.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/19488.",2020,"In-depth qualitative interviews will also be conducted 6 months post intervention to provide deeper insight into experiences with EatSmart and a more comprehensive description of the program's appeal.
","['disadvantaged people living with T2D to eat healthily on a budget and improve diabetes self-management', 'People of low socioeconomic position (SEP', 'Sixty socioeconomically disadvantaged people with T2D aged 18 to 75 years', 'Disadvantaged People']","['Web-Based and Mobile Healthy Eating Intervention', 'fully automated web-based and mobile-delivered healthy eating behavior change program']",[],"[{'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],60.0,0.10529,"In-depth qualitative interviews will also be conducted 6 months post intervention to provide deeper insight into experiences with EatSmart and a more comprehensive description of the program's appeal.
","[{'ForeName': 'Nazgol', 'Initials': 'N', 'LastName': 'Karimi', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Crawford', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Opie', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Maddison', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': ""O'Connell"", 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Peter Shane', 'Initials': 'PS', 'LastName': 'Hamblin', 'Affiliation': 'Diabetes & Endocrinology Centre, Sunshine Hospital, St Albans, Australia.'}, {'ForeName': 'Ashley Huixian', 'Initials': 'AH', 'LastName': 'Ng', 'Affiliation': 'Department of Dietetics, Human Nutrition and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Steele', 'Affiliation': 'Diabetes Education Services, Sunshine Hospital, St Albans, Australia.'}, {'ForeName': 'Bodil', 'Initials': 'B', 'LastName': 'Rasmussen', 'Affiliation': 'School of Nursing and Midwifery, Deakin University, Geelong, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Ball', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}]",JMIR research protocols,['10.2196/19488']
2291,33155711,"Effect of a 1-year short message service in detoxified alcohol-dependent patients (CAPS): a multi-centre, open-label randomised controlled trial.","BACKGROUND AND AIMS
Existing evidence suggests that text message interventions can help people reduce their alcohol consumption. However, studies with alcohol dependent patients are lacking. In this study a 1-year automatic mobile phone-based short messaging service (SMS) intervention on alcohol consumption in patients after alcohol detoxification in hospital was compared with treatment as usual.
DESIGN
Multicenter, randomized, controlled, 2 parallel-group, observer-blinded trial SETTING: Primary and secondary care: 4 hospitals and community (1 million residents, 7600 km 2 area in Germany).
PARTICIPANTS
A total of 462 patients with alcohol-dependence (ICD-10) were included during inpatient detoxification treatment. Patients were randomly assigned (1:1) to an SMS intervention and treatment as usual (SMS+TAU; n=230; mean age: 45.4 years; 22.6% women) or TAU alone (n=232 mean age: 44.5 years; 22.8% women).
INTERVENTIONS
Planned, automated messages were sent to patients over 1 year to record assistance needs. A ""Yes"" or missing response triggered a phone call from a hospital therapist. Outcome was assessed by an independent survey center.
MEASUREMENTS
The primary endpoint was a 3-category alcohol consumption measure covering months 10-12 after discharge: abstinence, non-heavy drinking, heavy drinking (men >60 g/d; women >40 g/d equal to WHO criteria: high risk and very high risk, mean consumption). Secondary endpoints were number of abstinent days over 12 months and frequency of abstinence.
FINDINGS
The arms differed primarily in the heavy drinking category (intervention group 22.2%, TAU-only group 32.3%) in months 9 to 12. This is reflected by an odds ratio (OR) 1.68, 95%CI 1.11 to 2.54, p = 0.015 for heavy drinking vs. non-heavy drinking/abstinence. No difference between treatments was found with respect to any drinking vs. abstinence (OR=1.13). These results were confirmed by models adjusting for randomisation strata.
CONCLUSIONS
In Germany, a 12 month mobile phone short messaging service-based intervention enhanced the reduction in heavy drinking for 1 year in routine care among adults with alcohol dependence discharged from inpatient alcohol detoxification.",2020,"In Germany, a 12 month mobile phone short messaging service-based intervention enhanced the reduction in heavy drinking for 1 year in routine care among adults with alcohol dependence discharged from inpatient alcohol detoxification.","['detoxified alcohol-dependent patients (CAPS', 'A total of 462 patients with alcohol-dependence (ICD-10', 'Primary and secondary care: 4 hospitals and community (1 million residents, 7600 km 2 area in Germany', 'patients after alcohol detoxification in hospital', 'n=232 mean age: 44.5 years; 22.8% women', 'n=230; mean age: 45.4 years; 22.6% women) or', ' women ', 'adults with alcohol dependence discharged from inpatient alcohol detoxification']","['SMS intervention and treatment as usual (SMS+TAU', 'automatic mobile phone-based short messaging service (SMS) intervention', '1-year short message service', 'TAU alone']","['alcohol consumption', 'heavy drinking', '3-category alcohol consumption measure covering months 10-12 after discharge: abstinence, non-heavy drinking, heavy drinking (men', 'number of abstinent days over 12 months and frequency of abstinence']","[{'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0204597', 'cui_str': 'Detoxication psychiatric therapy for alcoholism'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0585022', 'cui_str': 'During day'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",462.0,0.197327,"In Germany, a 12 month mobile phone short messaging service-based intervention enhanced the reduction in heavy drinking for 1 year in routine care among adults with alcohol dependence discharged from inpatient alcohol detoxification.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lucht', 'Affiliation': 'Department of Psychiatry and Psychotherapy at Helios Hanseklinikum Stralsund, Stralsund, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Quellmalz', 'Affiliation': 'Department of Psychiatry and Psychotherapy at Helios Hanseklinikum Stralsund, Stralsund, Germany.'}, {'ForeName': 'Meinhard', 'Initials': 'M', 'LastName': 'Mende', 'Affiliation': 'Clinical Trial Centre (CTC) Leipzig, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Broda', 'Affiliation': 'Clinical Trial Centre (CTC) Leipzig, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Anett', 'Initials': 'A', 'LastName': 'Schmiedeknecht', 'Affiliation': 'Clinical Trial Centre (CTC) Leipzig, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Brosteanu', 'Affiliation': 'Clinical Trial Centre (CTC) Leipzig, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Höppner-Buchmann', 'Affiliation': 'Hospital of Geriatric Psychiatry; Helios Hospital Schwerin, Schwerin, Germany and Department of Psychiatry and Psychotherapy, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Langosch', 'Affiliation': 'Bethanien Hospital for Psychiatry, Psychosomatics, and Psychotherapy, Greifswald, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Stuppe', 'Affiliation': 'Hospital of Addiction Medicine; Helios Hospital Schwerin, Schwerin, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schomerus', 'Affiliation': 'Department of Psychiatry, Medical Faculty, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klauer', 'Affiliation': 'Department of Psychiatry and Psychotherapy at Helios Hanseklinikum Stralsund, Stralsund, Germany.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Grabe', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Harald J', 'Initials': 'HJ', 'LastName': 'Freyberger', 'Affiliation': 'Department of Psychiatry and Psychotherapy at Helios Hanseklinikum Stralsund, Stralsund, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'John', 'Affiliation': 'Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': 'Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany.'}]","Addiction (Abingdon, England)",['10.1111/add.15313']
2292,33155754,The neutrophil to lymphocyte ratio (NLR) and the presence of large nodal mass are independent predictors of early response: A subanalysis of the prospective phase II PET-2-adapted HD0607 trial.,"BACKGROUND
The neutrophil to lymphocyte ratio (NLR) and the lymphocyte to monocyte ratio (LMR) can reflect both the myeloid dysfunction and T-cell immune suppression and have prognostic significance.
METHODS
In 771 newly diagnosed advanced-stage Hodgkin Lymphoma (HL) patients we evaluated the baseline values of NLR and LMR as predictors of clinical outcome. According to the multicenter prospective phase II GITIL-HD0607 trial, all patients received two ABVD courses and if PET-2 negative received four additional ABVD cycles while if PET-2-positive patients were randomized to either BEACOPP escalated (Be) plus BEACOPP baseline (Bb) (4 + 4 courses) or Be + Bb (4 + 4) and Rituximab. PET scans were centrally reviewed by an expert panel by Blinded Independent Central Review.
RESULTS
Higher NLR and lower LMR were associated with a PET-2 positivity and failure to achieve long-term disease control, respectively. By univariate and multivariate analysis, large nodal mass (>7 cm), IPS ≥ 3, NLR > 6 were strong independent predictors of early PET-2 response after ABVD. Only NLR > 6 and IPS ≥ 3 were strong independent predictors of outcome at diagnosis; however, when PET-2 status was added, only PET-2-positive status and IPS ≥ 3 were independent predictors of PFS. Focusing on PET-2-negative patients, those with NLR > 6 had an inferior 3-year PFS compared to patients with NLR ≤ 6 (84% vs 89% months, P = .03).
CONCLUSION
In advanced-stage HL patients treated with a PET-2-driven strategy, IPS ≥ 3 and NLR > 6 are independent predictors of outcome at diagnosis while the presence of large nodal mass, IPS ≥ 3, and NLR > 6 at diagnosis are independent predictors of early ABVD response.",2020,"By univariate and multivariate analysis, large nodal mass (>7 cm), IPS ≥ 3, NLR > 6 were strong independent predictors of early PET-2 response after ABVD.","['771 newly diagnosed advanced-stage Hodgkin Lymphoma (HL) patients', 'In advanced-stage HL patients treated with a PET-2-driven strategy, IPS\xa0≥\xa03 and NLR\xa0']","['BEACOPP escalated (Be) plus BEACOPP baseline (Bb) ', 'Rituximab']","['inferior 3-year PFS', 'large nodal mass, IPS\xa0≥\xa03, and NLR\xa0', 'neutrophil to lymphocyte ratio (NLR']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",771.0,0.0903095,"By univariate and multivariate analysis, large nodal mass (>7 cm), IPS ≥ 3, NLR > 6 were strong independent predictors of early PET-2 response after ABVD.","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Romano', 'Affiliation': 'Dipartimento di Specialità medico-Chirurgiche, CHIRMED, Sezione di Ematologia, Università degli studi di Catania, Catania, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Pavoni', 'Affiliation': 'Ematologia, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Di Raimondo', 'Affiliation': 'Dipartimento di Specialità medico-Chirurgiche, CHIRMED, Sezione di Ematologia, Università degli studi di Catania, Catania, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Tarella', 'Affiliation': 'Onco-Hematology Unit, Istituto Europeo di Oncologia, Milan, Italy.'}, {'ForeName': 'Simonetta', 'Initials': 'S', 'LastName': 'Viviani', 'Affiliation': 'Ematologia e onco-ematologia pediatrica, Fondazione IRCSS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rossi', 'Affiliation': 'Ematologia, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Patti', 'Affiliation': 'Ematologia, Azienda Villa Sofia-Cervello, Palermo, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Picardi', 'Affiliation': 'Ematologia, Università Federico II, Napoli, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cantonetti', 'Affiliation': 'Oncoematologia, Policlinico Tor Vergata, Roma, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'La Nasa', 'Affiliation': 'Ematologia, Ospedale R.Binaghi, Cagliari, Italy.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Trentin', 'Affiliation': 'Ematologia Dipartimento di Medicina, Università di Padova, Padova, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bolis', 'Affiliation': 'Ematologia, Ospedale San Gerardo, Monza, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Zoli', 'Affiliation': 'Ematologia, Ospedale S. Camillo, Roma, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Gavarotti', 'Affiliation': 'Ematologia Universitaria, Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corradini', 'Affiliation': 'Dipartimento di oncologia-ematologia, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cimminiello', 'Affiliation': 'Divisione Universitaria di Ematologia, Ospedale San Carlo, Potenza, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Schiavotto', 'Affiliation': 'Ematologia, Presidio Ospedaliero S. Bortolo, Vicenza, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Parvis', 'Affiliation': 'Divisione Universitaria Medicina Interna, AO San Luigi, Orbassano, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Zanotti', 'Affiliation': 'Divisione di Medicina, Unità di Ematologia, Azienda Ospedaliera Universitaria Integrata, Verona, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Gini', 'Affiliation': 'Divisione Universitaria di Ematologia, Nuovo Ospedale Torrette, Ancona, Italy.'}, {'ForeName': 'Andrés J M', 'Initials': 'AJM', 'LastName': 'Ferreri', 'Affiliation': 'Unità di Ricerca Clinica Linfomi, IRCSS Ospedale San Raffaele, Milano, Italy.'}, {'ForeName': 'Piera', 'Initials': 'P', 'LastName': 'Viero', 'Affiliation': ""Ematologia, Ospedale dell'Angelo, Mestre, Italy.""}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Chauvie', 'Affiliation': 'Medicina Nucleare Azienda Ospedaliera Santa Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Biggi', 'Affiliation': 'Medicina Nucleare Azienda Ospedaliera Santa Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Massimo Gianni', 'Affiliation': 'Onco-Hematology Unit, Istituto Europeo di Oncologia, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gallamini', 'Affiliation': 'Department recherch e innovation et statistique, Centre A. Lacassagne, Nice, France.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rambaldi', 'Affiliation': 'Ematologia, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}]",Cancer medicine,['10.1002/cam4.3396']
2293,33155824,Clinical Management and Pump Parameter Adjustment of the Control-IQ Closed-loop Control System: Results from a 6-month Multicenter Randomized Clinical Trial.,"BACKGROUND
Data are limited on the need for and benefits of pump setting optimization with automated insulin delivery. We examined clinical management of a closed-loop control (CLC) system and its relationship to glycemic outcomes.
MATERIALS AND METHODS
We analyzed personal parameter adjustments in 168 participants in a 6-month multicenter trial of CLC with Control-IQ vs sensor-augmented pump therapy (SAP). Preset parameters (BR=basal rates, CF=correction factors, CR=carbohydrate ratios) were optimized at randomization, 2 and 13 weeks, for safety issues, participant concerns, or initiation by participants' usual diabetes care team. Time-in-range (TIR 70-180mg/dL) was compared in the week preceding and following parameter changes.
RESULTS
In 607 encounters for parameter changes, there were fewer adjustments for CLC than SAP (3.4 vs. 4.1/participant). Adjustments involved BR (CLC 69%, SAP 80%), CR (CLC 68%, SAP 50%), CF (CLC 44%, SAP 41%), and overnight parameters (CLC 62%, SAP 75%). TIR preceding and following adjustments was CLC 71.2% and 71.3% and SAP 61.0% and 62.9%. The highest baseline HbA1c CLC subgroup had the largest TIR improvement (51.2% v 57.7%). When a CR was made more aggressive in the CLC group, postprandial time above 180mg/dL was 43.1% preceding and 36.0% following the change. The median postprandial time <70mg/dL before making CR less aggressive was 1.8%, and following the change was 0.7%.
CONCLUSION
No difference in TIR was detected with parameter changes overall but they may have an effect in higher HbA1c1c subgroups or following user-directed boluses suggesting changes may matter more in suboptimal control or during discrete periods of the day.",2020,No difference in TIR was detected with parameter changes overall but they may have an effect in higher HbA1c1c subgroups or following user-directed boluses suggesting changes may matter more in suboptimal control or during discrete periods of the day.,['We analyzed personal parameter adjustments in 168 participants in a 6-month multicenter trial of'],"['closed-loop control (CLC) system', 'CLC with Control-IQ vs sensor-augmented pump therapy (SAP', 'Control-IQ Closed-loop Control System']","['postprandial time', 'Preset parameters (BR=basal rates, CF=correction factors, CR=carbohydrate ratios', 'median postprandial time', 'largest TIR improvement', 'TIR']","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}]",,0.124754,No difference in TIR was detected with parameter changes overall but they may have an effect in higher HbA1c1c subgroups or following user-directed boluses suggesting changes may matter more in suboptimal control or during discrete periods of the day.,"[{'ForeName': 'Grenye', 'Initials': 'G', 'LastName': ""O'Malley"", 'Affiliation': ""Icahn School of Medicine at Mount Sinai, 5925, New York, New York, United States; grenye.o'malley@mssm.edu.""}, {'ForeName': 'Laurel H', 'Initials': 'LH', 'LastName': 'Messer', 'Affiliation': 'University of Colorado Denver Barbara Davis Center for Childhood Diabetes, 21610, Denver, Colorado, United States; laurel.messer@ucdenver.edu.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Mt Sinai, Endocrinology, 1 Gustave L Levy Place, Box 1055, NY, New York, United States, 10029; carol.levy@mssm.edu.'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Pinsker', 'Affiliation': 'Sansum Diabetes Research Institute, 2219 Bath St., Santa Barbara, California, United States, 93105; jpinsker@sansum.org.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Forlenza', 'Affiliation': 'University of Colorado Denver, 12226, Barbara Davis Center for Childhood Diabetes, 1775 Aurora Court, A140, Denver, Colorado, United States, 80204; gregory.forlenza@cuanschutz.edu.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Isganaitis', 'Affiliation': 'Joslin Diabetes Center, 10577, Boston, Massachusetts, United States; elvira.isganaitis@joslin.harvard.edu.'}, {'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': 'Mayo Clinic , Endocrinology, W 18 A Mayo Building, Rochester, United States, 55905.'}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': ""Stanford University School of Medicine, 10624, Lucile Packard Children's Hospital - Pediatric Endocrinology, 780 Welch Road, 3rd floor, Palo Alto, California, United States, 94304; layae@stanford.edu.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Raghinaru', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, United States; draghinaru@Jaeb.org.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lum', 'Affiliation': 'Jaeb Centre for Health Research, 371336, 15310 Amberly Dr, SUite 350, Tampa, Florida, United States, 33647-1642; jl_manuscripts@jaeb.org.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'University of Virginia Health System, 12350, Charlottesville, Virginia, United States; SAB2F@hscmail.mcc.virginia.edu.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0472']
2294,33156005,Combination therapy with topical minoxidil and nano-microneedle-assisted fibroblast growth factor for male androgenetic alopecia: a randomized controlled trial in Chinese patients.,,2020,,"['male androgenetic alopecia', 'Chinese patients']",['topical minoxidil and nano-microneedle-assisted fibroblast growth factor'],[],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0730881', 'cui_str': 'Regaine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0016026', 'cui_str': 'Fibroblast growth factor'}]",[],,0.0683755,,"[{'ForeName': 'Cheng-Qian', 'Initials': 'CQ', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, No. 1 Hospital of China Medical University, Shenyang, Liaoning 110001, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'NHC Key Laboratory of Immunodermatology (China Medical University), Liaoning 110001, China.'}, {'ForeName': 'Meng-Er', 'Initials': 'ME', 'LastName': 'Guo', 'Affiliation': 'Department of Dermatology, No. 1 Hospital of China Medical University, Shenyang, Liaoning 110001, China.'}, {'ForeName': 'Xiao-Kun', 'Initials': 'XK', 'LastName': 'Li', 'Affiliation': 'School of Pharmacy, Wenzhou Medical University, Wenzhou, Zhejiang 325035, China.'}, {'ForeName': 'Hong-Duo', 'Initials': 'HD', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, No. 1 Hospital of China Medical University, Shenyang, Liaoning 110001, China.'}, {'ForeName': 'Yuan-Hong', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, No. 1 Hospital of China Medical University, Shenyang, Liaoning 110001, China.'}, {'ForeName': 'Xue-Gang', 'Initials': 'XG', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, No. 1 Hospital of China Medical University, Shenyang, Liaoning 110001, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000001195']
2295,33156076,Microthin Descemet Stripping Automated Endothelial Keratoplasty Versus Descemet Membrane Endothelial Keratoplasty: A Randomized Clinical Trial.,"PURPOSE
To compare visual outcomes, complications, and vision-related quality of life (QoL) after microthin Descemet stripping automated endothelial keratoplasty (MT-DSAEK) versus Descemet membrane endothelial keratoplasty (DMEK) for the management of corneal endothelial dysfunction in Fuchs dystrophy.
METHODS
This is a prospective, double-blinded randomized controlled clinical trial. Patients with visually significant endothelial decompensation from Fuchs dystrophy were prospectively randomized to receive MT-DSAEK or DMEK surgery. The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 12 months. Secondary outcomes included refraction, keratometry, endothelial cell count, complications, and vision-related QoL at 6 and 12 months postoperatively.
RESULTS
A total of 56 eyes of 56 patients were enrolled, 28 in each group. Postoperatively, LogMAR mean BSCVA in the MT-DSAEK group was 0.17 ± 0.08 and 0.11 ± 0.09 at 6 and 12 months compared with 0.09 ± 0.13 and 0.04 ± 0.13 after DMEK (P = 0.03, P = 0.002 respectively) with the DMEK cohort achieving 3.5 logarithm of the minimum angle of resolution letters better BSCVA at 1 year compared with MT-DSAEK. Complication rates were similar with 3.5% rebubbling rate in both groups, 1 primary graft failure in DMEK and a single endothelial rejection in the MT-DSAEK arm. Vision-related QoL was comparable at 6 and 12 months postoperatively, and no eyes demonstrated loss of vision from preoperative BSCVA.
CONCLUSIONS
DMEK surgery resulted in significantly better BSCVA at 1, 3, 6, and 12 months postoperatively compared with MT-DSAEK. Patient satisfaction was similar with no differences reported in vision-related QoL scores, as was the complications profile between groups. Thus, our results favor DMEK as the better choice procedure for eyes with Fuchs-related corneal decompensation without ocular comorbidities.",2020,"Complication rates were similar with 3.5% rebubbling rate in both groups, 1 primary graft failure in DMEK and a single endothelial rejection in the MT-DSAEK arm.","['corneal endothelial dysfunction in Fuchs dystrophy', 'A total of 56 eyes of 56 patients were enrolled, 28 in each group', 'Patients with visually significant endothelial decompensation from Fuchs dystrophy', 'eyes with Fuchs-related corneal decompensation without ocular comorbidities']","['MT-DSAEK or DMEK surgery', 'Microthin Descemet Stripping Automated Endothelial Keratoplasty', 'Descemet Membrane Endothelial Keratoplasty', 'microthin Descemet stripping automated endothelial keratoplasty (MT-DSAEK) versus Descemet membrane endothelial keratoplasty (DMEK']","['refraction, keratometry, endothelial cell count, complications, and vision-related QoL at 6 and 12 months postoperatively', 'Patient satisfaction', 'Vision-related QoL', 'Complication rates', 'spectacle-corrected visual acuity (BSCVA', 'BSCVA', 'LogMAR mean BSCVA', 'vision-related QoL scores', 'visual outcomes, complications, and vision-related quality of life (QoL']","[{'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0026850', 'cui_str': 'Muscular dystrophy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0948284', 'cui_str': 'Corneal decompensation'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2366835', 'cui_str': 'Endothelial keratoplasty'}, {'cui': 'C4302773', 'cui_str': ""Descemet's membrane endothelial keratoplasty""}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",56.0,0.298424,"Complication rates were similar with 3.5% rebubbling rate in both groups, 1 primary graft failure in DMEK and a single endothelial rejection in the MT-DSAEK arm.","[{'ForeName': 'Artemis', 'Initials': 'A', 'LastName': 'Matsou', 'Affiliation': 'Department of Ophthalmology, Cambridge University Hospitals and Cambridge Eye Research Centre, Cambridge, UK.'}, {'ForeName': 'Rathin', 'Initials': 'R', 'LastName': 'Pujari', 'Affiliation': 'Department of Ophthalmology, Cambridge University Hospitals and Cambridge Eye Research Centre, Cambridge, UK.'}, {'ForeName': 'Hammad', 'Initials': 'H', 'LastName': 'Sarwar', 'Affiliation': 'Department of Ophthalmology, Cambridge University Hospitals and Cambridge Eye Research Centre, Cambridge, UK.'}, {'ForeName': 'Mrinal', 'Initials': 'M', 'LastName': 'Rana', 'Affiliation': 'Department of Ophthalmology, Cambridge University Hospitals and Cambridge Eye Research Centre, Cambridge, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Myerscough', 'Affiliation': 'Department of Ophthalmology, Cambridge University Hospitals and Cambridge Eye Research Centre, Cambridge, UK.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Thomson', 'Affiliation': 'Department of Ophthalmology, Cambridge University Hospitals and Cambridge Eye Research Centre, Cambridge, UK.'}, {'ForeName': 'Girinath', 'Initials': 'G', 'LastName': 'Nandakumar', 'Affiliation': 'Department of Ophthalmology, Cambridge University Hospitals and Cambridge Eye Research Centre, Cambridge, UK.'}, {'ForeName': 'Jufen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Vision and Eye Research Institute, School of Medicine, Faculty of Health, Education, Medicine and Social Care, Anglia Ruskin University, Cambridge, UK.'}, {'ForeName': 'Madhavan S', 'Initials': 'MS', 'LastName': 'Rajan', 'Affiliation': 'Department of Ophthalmology, Cambridge University Hospitals and Cambridge Eye Research Centre, Cambridge, UK.'}]",Cornea,['10.1097/ICO.0000000000002601']
2296,33156099,Fendrix vs Engerix-B for Primo-Vaccination Against Hepatitis B Infection in Patients With Inflammatory Bowel Disease: A Randomized Clinical Trial.,"INTRODUCTION
To compare Engerix-B and Fendrix hepatitis B virus for primo vaccination in inflammatory bowel disease (IBD).
METHODS
Patients with IBD were randomized 1:1 to receive Engerix-B double dose or Fendrix single dose at months 0, 1, 2, and 6. Anti-HBs titers were measured 2 months after the third and fourth doses. Response to vaccination was defined as anti-HBs ≥100 UI/L. Anti-HBs titers were measured 2 months after the third and fourth doses and again at 6 and 12 months after the fourth dose.
RESULTS
A total of 173 patients were randomized (54% received Engerix-B and 46% Fendrix). Overall, 45% of patients responded (anti-HBs ≥100 IU/L) after 3 doses and 71% after the fourth dose. The response rate after the fourth dose was 75% with Fendrix vs 68% with Engerix-B (P = 0.3). Older age and treatment with steroids, immunomodulators, or anti-tumor necrosis factor were associated with a lower probability of response. However, the type of vaccine was not associated with the response. Anti-HBs titer negativization occurred in 13% of patients after 6 months and 20% after 12 months. Anti-HBs ≥100 IU/L after vaccination was the only factor associated with maintaining anti-HBs titers during follow-up.
DISCUSSION
We could not demonstrate a higher response rate of Fendrix (single dose) over Engerix-B (double dose). A 4-dose schedule is more effective than a 3-dose regimen. Older age and treatment with immunomodulators or anti-tumor necrosis factors impaired the success. A high proportion of IBD patients with protective anti-HBs titers after vaccination loose them over time. The risk of losing protective anti-HBs titers is increased in patients achieving anti-HBs <100 IU/L after the vaccination.",2020,The response rate after the fourth dose was 75% with Fendrix vs 68% with Engerix-B (P = 0.3).,"['Patients with IBD', 'With Inflammatory Bowel Disease', 'A total of 173 patients', 'Patients']","['Fendrix vs Engerix-B for Primo-Vaccination', 'Engerix-B double dose or Fendrix single']","['risk of losing protective anti-HBs titers', 'Anti-HBs titer negativization', 'response rate', 'Anti-HBs titers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C1872587', 'cui_str': 'Fendrix'}, {'cui': 'C0116078', 'cui_str': 'Engerix-B'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0201478', 'cui_str': 'Hepatitis B surface antibody measurement'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",173.0,0.124734,The response rate after the fourth dose was 75% with Fendrix vs 68% with Engerix-B (P = 0.3).,"[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Chaparro', 'Affiliation': 'Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Gordillo', 'Affiliation': 'Gastroenterology Unit, Hospital Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Eugeni', 'Initials': 'E', 'LastName': 'Domènech', 'Affiliation': 'Gastroenterology Unit, Hospital Universitari Germans Trias i Pujol, CIBERehd, Badalona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Esteve', 'Affiliation': 'Gastroenterology Unit, Hospital Universitari Mutua Terrassa, CIBERehd, Terrassa, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Barreiro-de Acosta', 'Affiliation': 'Gastroenterology Unit, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Villoria', 'Affiliation': 'Gastroenterology Unit, Hospital de Sabadell, CIBERehd, Sabadell, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Iglesias-Flores', 'Affiliation': 'Gastroenterology Unit, Hospital Universitario Reina Sofía, IMIBIC Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Blasi', 'Affiliation': 'Gastroenterology Unit, Hospital Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'Naves', 'Affiliation': 'Gastroenterology Unit, Hospital Universitari Germans Trias i Pujol, CIBERehd, Badalona, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Benítez', 'Affiliation': 'Gastroenterology Unit, Hospital Universitari Mutua Terrassa, CIBERehd, Terrassa, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Nieto', 'Affiliation': 'Gastroenterology Unit, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Calvet', 'Affiliation': 'Gastroenterology Unit, Hospital de Sabadell, CIBERehd, Sabadell, Spain.'}, {'ForeName': 'Valle', 'Initials': 'V', 'LastName': 'García-Sánchez', 'Affiliation': 'Gastroenterology Unit, Hospital Universitario Reina Sofía, IMIBIC Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Villagrasa', 'Affiliation': 'Preventive Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain.'}, {'ForeName': 'Alicia C', 'Initials': 'AC', 'LastName': 'Marin', 'Affiliation': 'Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.'}, {'ForeName': 'María G', 'Initials': 'MG', 'LastName': 'Donday', 'Affiliation': 'Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Abad-Santos', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Facultad de Medicina, Universidad Autónoma de Madrid (UAM), Instituto de Investigación Sanitaria La Princesa (IP), CIBERehd, Madrid, Spain.'}, {'ForeName': 'Javier P', 'Initials': 'JP', 'LastName': 'Gisbert', 'Affiliation': 'Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000926']
2297,33156110,Three-Dimensional-Printed Liver Model Helps Learners Identify Hepatic Subsegments: A Randomized-Controlled Cross-Over Trial.,"INTRODUCTION
The purpose of this study was to find out whether 3-dimensional (3D)-printed models improved the learners' ability to identify liver segments.
METHODS
A total of 116 physicians from 3 disciplines were tested in a cross-over trial at baseline and after teaching with 3D models and 2-dimensional (2D) images. Adjusted multilevel-mixed models were used to compare scores at baseline and after 3D and 2D.
RESULTS
Accuracy in identifying hepatic segments was higher with 3D first than 2D (77% vs 69%; P = 0.05) and not significantly improved by a combination of 3D and 2D. Increased confidence in segment identification was highest in trainees after 3D (P = 0.04).
DISCUSSION
3D-printed models facilitate learning hepatic segmental anatomy.",2020,A total of 116 physicians from 3 disciplines were tested in a cross-over trial at baseline and after teaching with 3D models and 2-dimensional (2D) images.,['A total of 116 physicians from 3 disciplines were tested in a cross-over trial at baseline and after teaching with 3D models and 2-dimensional (2D) images'],[],['confidence in segment identification'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",[],"[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}]",116.0,0.0489261,A total of 116 physicians from 3 disciplines were tested in a cross-over trial at baseline and after teaching with 3D models and 2-dimensional (2D) images.,"[{'ForeName': 'Victor G', 'Initials': 'VG', 'LastName': 'Chedid', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Amika A', 'Initials': 'AA', 'LastName': 'Kamath', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'M Knudsen', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Frimannsdottir', 'Affiliation': 'Mayo Clinic Center for Clinical and Translational Science, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Yost', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'R Geske', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Morris', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Timucin', 'Initials': 'T', 'LastName': 'Taner', 'Affiliation': 'Division of Transplantation Surgery, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Kamath', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000958']
2298,33156120,External Corroboration That Corticosteroids May Be Harmful to Septic Shock Endotype A Patients.,"OBJECTIVES
We previously reported gene expression-based endotypes of pediatric septic shock, endotypes A and B, and that corticosteroid exposure was independently associated with increased mortality among pediatric endotype A patients. The Vasopressin vs Norepinephrine as Initial Therapy in Septic Shock trial tested the efficacy of vasopressin as initial vasopressor therapy for septic shock among adult patients, when compared with norepinephrine. Patients who reached a prespecified dose of either vasopressor were further randomized to receive hydrocortisone or placebo. A proportion of patients in the Vasopressin vs Norepinephrine as Initial Therapy in Septic Shock trial had transcriptomic data generated at baseline using whole blood-derived messenger RNA. We used the publicly available transcriptomic data from the Vasopressin vs Norepinephrine as Initial Therapy in Septic Shock trial to assign the study subjects to pediatric septic shock endotype A or B, and tested the hypothesis that hydrocortisone treatment is associated with increased mortality among patients in endotype A.
DESIGN
Secondary analysis of publicly available transcriptomic data.
SETTING
Multiple adult ICUs.
PATIENTS
Adults with septic shock randomized to hydrocortisone (n = 47) or placebo (n = 50).
INTERVENTIONS
Randomization to the Vasopressin vs Norepinephrine as Initial Therapy in Septic Shock trial experimental arms.
MEASUREMENTS AND MAIN RESULTS
Endotype A patients receiving hydrocortisone had a mortality rate of 46%, whereas endotype A patients receiving placebo had a mortality rate of 22% (p = 0.105). In contrast, the mortality rates for endotype B patients receiving hydrocortisone or placebo were 19% and 22%, respectively. The odds of death were more than three times greater in endotype A patients receiving hydrocortisone than endotype A patients receiving placebo (p = 0.05).
CONCLUSIONS
This exploratory analysis provides further evidence that corticosteroid exposure may be associated with increased mortality among septic shock endotype A patients.",2020,"endotypes A and B, and that corticosteroid exposure was independently associated with increased mortality among pediatric endotype A patients.","['n = 47) or', 'Multiple adult ICUs', 'adult patients', 'n = 50', 'Patients who reached a prespecified dose of either vasopressor', 'Adults with septic shock randomized to']","['norepinephrine', 'Vasopressin vs Norepinephrine', 'hydrocortisone or placebo', 'vasopressin', 'Corticosteroids', 'placebo', 'hydrocortisone', 'External Corroboration', 'endotype']","['odds of death', 'mortality rate', 'mortality', 'mortality rates']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205101', 'cui_str': 'External'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",50.0,0.646051,"endotypes A and B, and that corticosteroid exposure was independently associated with increased mortality among pediatric endotype A patients.","[{'ForeName': 'Hector R', 'Initials': 'HR', 'LastName': 'Wong', 'Affiliation': ""Division of Critical Care Medicine, Cincinnati Children's Hospital Medical Center and Cincinnati Children's Research Foundation, Cincinnati, OH.""}, {'ForeName': 'Kimberly W', 'Initials': 'KW', 'LastName': 'Hart', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Sweeney', 'Affiliation': 'Inflammatix, Burlingame, CA.'}]",Critical care medicine,['10.1097/CCM.0000000000004709']
2299,33156869,The association of primary aldosteronism with glaucoma-related fundus abnormalities.,"PURPOSE
To elucidate glaucoma-related fundus abnormalities in patients with primary aldosteronism (PA).
METHODS
The study compared 272 eyes from 137 PA patients and 352 eyes from 177 control subjects selected randomly from 1173 participants of a public glaucoma screening. The presence of glaucomatous optic disc appearance (rim thinning and cup enlargement) and retinal nerve fiber layer defects (RNFLDs) was determined independently from fundus photographs. The results were compared between the PA and control groups.
RESULTS
There were 9 patients (6.6%) with glaucomatous optic disc abnormalities in the PA group and 10 cases (5.6%) identified in the control group (p = 0.92). RNFLDs were detected more frequently in the PA group (55 eyes, 20.2%) than in the control group (26 eyes, 7.4%; p<0.001). The two types of RNFLDs were classified as either having their central ends at the disc margin (D) or away from the disc margin and around the retinal vessels (V). Type D and V RNFLDs were detected in 35 (12.9%) and 26 (9.6%) eyes in the PA group and in 25 (7.1%) and 4 (1.1%) eyes in the control group, respectively. Both types of RNFLDs were more frequent in the PA group than in the control group (Type D and V, p = 0.03, <0.001, respectively).
CONCLUSION
Although the prevalence of glaucomatous optic disc appearance did not differ between the two groups, RNFLDs were more frequent in PA patients than in the control group. Moreover, RNFLDs with their central ends located around retinal vessels were characteristic of PA patients.",2020,"Both types of RNFLDs were more frequent in the PA group than in the control group (Type D and V, p = 0.03, <0.001, respectively).
","['272 eyes from 137 PA patients and 352 eyes from 177 control subjects selected randomly from 1173 participants of a public glaucoma screening', 'patients with primary aldosteronism (PA']",[],"['glaucomatous optic disc appearance (rim thinning and cup enlargement) and retinal nerve fiber layer defects (RNFLDs', 'glaucomatous optic disc appearance', 'Type D and V RNFLDs', 'glaucomatous optic disc abnormalities']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C1384514', 'cui_str': 'Primary aldosteronism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0702254', 'cui_str': 'Glaucoma screening'}]",[],"[{'cui': 'C0029127', 'cui_str': 'Optic disc structure'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0556630', 'cui_str': 'Anal penetration using tongue'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",1173.0,0.018529,"Both types of RNFLDs were more frequent in the PA group than in the control group (Type D and V, p = 0.03, <0.001, respectively).
","[{'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Ohshima', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Higashide', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}, {'ForeName': 'Kimikazu', 'Initials': 'K', 'LastName': 'Sakaguchi', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Sasaki', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Udagawa', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Ohkubo', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yoneda', 'Affiliation': 'Department of Cardiovascular and Internal Medicine, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}]",PloS one,['10.1371/journal.pone.0242090']
2300,33156923,The design of a Bayesian platform trial to prevent and eradicate inhibitors in patients with hemophilia.,"Among individuals with the rare congenital bleeding disorder hemophilia A, the major challenge is inhibitor formation, which is associated with significant morbidity and cost. Yet, as the optimal approach to prevent and eradicate inhibitors is not known, we are at equipoise. Because classic trial design is not practical in a rare disease setting, we designed 2 48-week randomized trials comparing ELOCTATE and emicizumab to prevent and eradicate inhibitors. To achieve statistical efficiency, we incorporated historic data (Bayesian priors) on inhibitor formation to allow preferential randomization to emicizumab, piecewise exponential survival models to determine mean and 95% confidence interval for inhibitor formation in each arm, and simulations to determine the best model design to optimize power. To achieve administrative efficiency, the trials will be performed with the same sites, staff, visit frequency, blood sampling, laboratories, and laboratory assays, with streamlined enrollment so patients developing inhibitors in the first trial may be enrolled on the second trial. The primary end point is the probability of inhibitor formation or inhibitor eradication, respectively. The design indicates early stopping rules for overwhelming evidence of superiority of the emicizumab arms. Simulations indicate that, with 66 subjects, the Prevention Trial will have 84% power to detect noninferiority of emicizumab to ELOCTATE with a margin of 10% if emicizumab is truly 10% superior to ELOCTATE; with 90 subjects, the Eradication Trial will have 80% power to detect 15% superiority of ELOCTATE immune tolerance induction with vs without emicizumab. Thus, a platform design provides statistical and administrative efficiency to conduct INHIBIT trials.",2020,"Simulations indicate that, with 66 subjects, the Prevention Trial will have 84% power to detect noninferiority of emicizumab to ELOCTATE with a margin of 10% if emicizumab is truly 10% superior to ELOCTATE; with 90 subjects, the Eradication Trial will have 80% power to detect 15% superiority of ELOCTATE immune tolerance induction with vs without emicizumab.","['66 subjects', 'patients with hemophilia', 'individuals with the rare congenital bleeding disorder hemophilia']",[],['probability of inhibitor formation or inhibitor eradication'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.0756505,"Simulations indicate that, with 66 subjects, the Prevention Trial will have 84% power to detect noninferiority of emicizumab to ELOCTATE with a margin of 10% if emicizumab is truly 10% superior to ELOCTATE; with 90 subjects, the Eradication Trial will have 80% power to detect 15% superiority of ELOCTATE immune tolerance induction with vs without emicizumab.","[{'ForeName': 'Marnie', 'Initials': 'M', 'LastName': 'Bertolet', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Brooks', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Margaret V', 'Initials': 'MV', 'LastName': 'Ragni', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA; and.'}]",Blood advances,['10.1182/bloodadvances.2020002789']
2301,33156981,Protocol Summary of the CAPTURE Validation in Primary Care Study.,"COPD often remains undiagnosed and untreated. To date COPD screening/case finding has not been designed to identify clinically significant COPD , disease ready for therapies beyond smoking cessation. Herein we describe the ongoing prospective, pragmatic cluster-randomized controlled trial to assess specificity and sensitivity of the CAPTURE (COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation) tool consisting of five questions and peak expiratory flow. The tool is designed to identify clinically significant COPD (FEV1/FVC <.7 plus FEV1% predicted <60% or increased for exacerbation) and explore the impact of CAPTURE-based screening on COPD diagnosis and treatment rates in primary care patients. Of a total planned enrollment of 5000 English- or Spanish-speaking patients ages 45 to 80 years without a prior COPD diagnosis from 100 primary care practices, 68 practices and 3064 patients have been enrolled. Practices are centrally randomized to either usual care or clinician receipt of patient-level CAPTURE results. All clinicians receive basic COPD education with those in intervention practices also receiving CAPTURE interpretation education. In a single visit, patient participants complete CAPTURE screening, pre- and post-bronchodilator spirometry and baseline demographic, and health questionnaires to validate CAPTURE sensitivity, specificity, and predictive value of identifying undiagnosed, clinically significant COPD. One-year follow-up chart reviews and participant surveys assess the impact of sharing versus not sharing CAPTURE results with clinicians on clinical outcomes; level of respiratory symptoms and events and clinicians' initiation of recommendation-concordant COPD care. This is one of the first U.S. studies to validate and assess impact of a simple COPD screening tool in primary care.",2020,"To date COPD screening/case finding has not been designed to identify clinically significant COPD , disease ready for therapies beyond smoking cessation.","['primary care patients', 'Primary Care', '5000 English- or Spanish-speaking patients ages 45 to 80 years without a prior COPD diagnosis from 100 primary care practices, 68 practices and 3064 patients have been enrolled']",[],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]",[],[],,0.064833,"To date COPD screening/case finding has not been designed to identify clinically significant COPD , disease ready for therapies beyond smoking cessation.","[{'ForeName': 'Barbara P', 'Initials': 'BP', 'LastName': 'Yawn', 'Affiliation': 'Department of Family and Community Health, University of Minnesota, Minneapolis, Minnesota, United States.'}, {'ForeName': 'Meilan', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, University of Michigan Health System, Ann Arbor, Michigan, United States.'}, {'ForeName': 'Barry M', 'Initials': 'BM', 'LastName': 'Make', 'Affiliation': 'Pulmonary Sciences and Critical Care Medicine, National Jewish Health, Denver, Colorado, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mannino', 'Affiliation': 'College of Public Health, Department of Preventive Medicine and Environmental Health, University of Kentucky, Lexington, Kentucky, United States.'}, {'ForeName': 'Randall W', 'Initials': 'RW', 'LastName': 'Brown', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, Michigan, United States.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Meldrum', 'Affiliation': 'Department of Internal Medicine, University of Michigan Health System, Ann Arbor, Michigan, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Murray', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, United States.'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, United States.'}, {'ForeName': 'Jacqueline S', 'Initials': 'JS', 'LastName': 'Bronicki', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, United States.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Leidy', 'Affiliation': 'Evidera, Bethesda, Maryland, United States.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Tapp', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, North Carolina, United States.'}, {'ForeName': 'Rowena J', 'Initials': 'RJ', 'LastName': 'Dolor', 'Affiliation': 'Division of General Internal Medicine, Duke University Medical Center, Durham, North Carolina, United States.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Joo', 'Affiliation': 'Medicine and Pulmonary and Critical Care, University of Illinois, Chicago, Illinois, United States.'}, {'ForeName': 'Lyndee', 'Initials': 'L', 'LastName': 'Knox', 'Affiliation': 'L.A. Net Community Health Center, Los Angeles, California, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Zittleman', 'Affiliation': 'Department of Family Medicine, University of Colorado, High Plains Research Network, Aurora, Colorado, United States.'}, {'ForeName': 'Byron M', 'Initials': 'BM', 'LastName': 'Thomashow', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Columbia University, New York, New York.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York, United States.'}]","Chronic obstructive pulmonary diseases (Miami, Fla.)",['10.15326/jcopdf.2020.0155']
2302,33156982,InforMing the PAthway of COPD Treatment Single-Inhaler Triple Therapy (Fluticasone Furoate/ Umeclidinium/ Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium /Vilanterol in Patients With COPD: Analysis of the Western Europe and North America Regions.,"Background
The IMPACT trial demonstrated lower moderate/severe exacerbation rates with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI or UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Since IMPACT was a global study, post-hoc analyses were conducted by geographic region to investigate potential differences in overall findings.
Methods
IMPACT was a 52-week, randomized, double-blind trial. Patients with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25µg, FF/VI 100/25µg, or UMEC/VI 62.5/25µg. Endpoints assessed in the overall, Western Europe (WE) and North America (NA) populations included on-treatment moderate/severe exacerbation (rates and time-to-first), trough forced expiratory volume in 1 second and St George's Respiratory Questionnaire (SGRQ) total score. Safety was assessed.
Results
Overall, 10,355 patients were enrolled, 3164 from WE, 2639 from NA. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in WE (rate ratios 0.82 [95%CI 0.74-0.91], P <.001 and 0.76 [0.67-0.87], P <.001) and NA (0.87 [0.77-0.97], P =.014 and 0.69 [0.60-0.80], P <.001). FF/UMEC/VI reduced time-to-first moderate/severe exacerbation and improved lung function versus FF/VI and UMEC/VI in both regions, and improved SGRQ total score in WE, but not NA. Safety profiles were generally similar between treatment groups/regions; the inhaled corticosteroid class effect of increased pneumonia incidence was seen in NA but not WE.
Conclusion
Consistent with intent-to-treat results, FF/UMEC/VI reduced moderate/severe exacerbation rate and risk and improved lung function in WE and NA; however, between-regions differences were seen for SGRQ total score and pneumonia incidence.",2020,FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in WE (rate ratios 0.82,"['patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations', 'Patients with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year', '10,355 patients were enrolled, 3164 from WE, 2639 from NA', 'Patients With COPD']","['fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI or UMEC/VI', 'COPD Treatment Single-Inhaler Triple Therapy (Fluticasone Furoate/ Umeclidinium/ Vilanterol', 'Fluticasone Furoate/Vilanterol and Umeclidinium', 'Vilanterol', 'UMEC/VI']","['SGRQ total score and pneumonia incidence', 'moderate/severe exacerbation rates', 'SGRQ total score', 'Safety profiles', 'FF/UMEC/VI reduced time-to-first moderate/severe exacerbation and improved lung function', 'severe exacerbation rates', 'moderate/severe exacerbation rate and risk and improved lung function', 'pneumonia incidence', ""overall, Western Europe (WE) and North America (NA) populations included on-treatment moderate/severe exacerbation (rates and time-to-first), trough forced expiratory volume in 1 second and St George's Respiratory Questionnaire (SGRQ) total score""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043129', 'cui_str': 'West European country'}, {'cui': 'C0028405', 'cui_str': 'North America'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0043129', 'cui_str': 'West European country'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]",10355.0,0.611894,FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in WE (rate ratios 0.82,"[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bourdin', 'Affiliation': 'Department of Pneumology and Addictology, University of Montpellier, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Devouassoux', 'Affiliation': 'Univ. Lyon, Université Claude-Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama, United States.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'College of Medicine and Health, University of Exeter Medical School, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'Pulmonary and Critical Care, University of Michigan, Ann Arbor, Michigan, United States.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, North Carolina, United States.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Kalhan', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lettis', 'Affiliation': 'GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Echave-Sustaeta María-Tomé', 'Affiliation': 'Respiratory Department, Hospital Universitario Quirónsalud Madrid, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'GlaxoSmithKline, Brentford, Middlesex, United Kingdom.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Weill Cornell Medicine, New York, New York, United States.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Quasny', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, North Carolina, United States.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Sail', 'Affiliation': 'GlaxoSmithKline, Paris, France.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Siler', 'Affiliation': 'Midwest Chest Consultants, PC, St Charles, Missouri, United States.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'The University of Manchester, Manchester University National Health Service Foundation Trust, United Kingdom.'}, {'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Thomashow', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care, Columbia University Medical Center, New York, New York, United States.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Watz', 'Affiliation': 'Pulmonary Research Institute at Lungen Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Section of Pulmonary and Critical Care Medicine, Airways Clinical Research Center, Baylor College of Medicine, Houston, Texas, United States.'}]","Chronic obstructive pulmonary diseases (Miami, Fla.)",['10.15326/jcopdf.2020.0158']
2303,33157008,A Prospective Study of Parental Perceptions of Rapid Whole-Genome and -Exome Sequencing among Seriously Ill Infants.,"Rapid diagnostic genomic sequencing recently became feasible for infants in intensive care units (ICUs). However, research regarding parents' perceived utility, adequacy of consent, and potential harms and benefits is lacking. Herein we report results of parental surveys of these domains from the second Newborn Sequencing in Genomic Medicine and Public Health (NSIGHT2) study, a randomized, controlled trial of rapid diagnostic genomic sequencing of infants in regional ICUs. More than 90% of parents reported feeling adequately informed to consent to diagnostic genomic sequencing. Despite only 23% (27) of 117 infants receiving genomic diagnoses, 97% (156) of 161 parents reported that testing was at least somewhat useful and 50.3% (88/161) reported no decisional regret (median 0, mean 10, range 0-100). Five of 117 families (4.3%) reported harm. Upon follow-up, one (1%) confirmed harm to child and parent related to negative results/no diagnosis, two (2%) reported stress or confusion, and two (2%) denied harm. In 81% (89) of 111 infants, families and clinicians agreed that genomic results were useful. Of the families for whom clinicians perceived harm from genomic testing, no parents reported harm. Positive tests/genomic diagnosis were more frequently perceived to be useful by parents, to benefit their infant, and to help manage potential symptoms (p < .05). In summary, the large majority of parents felt that first-tier, rapid, diagnostic genomic sequencing was beneficial for infants lacking etiologic diagnoses in ICUs. Most parents in this study perceived being adequately informed to consent, understood their child's results, and denied regret or harm from undergoing sequencing.",2020,Five of 117 families (4.3%) reported harm.,"['Seriously Ill Infants', 'infants in regional ICUs', 'infants in intensive care units (ICUs']",[],"['Positive tests/genomic diagnosis', 'stress or confusion', 'decisional regret']","[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0080101', 'cui_str': 'Regret'}]",,0.0554144,Five of 117 families (4.3%) reported harm.,"[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Cakici', 'Affiliation': ""Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA 92093, USA; Rady Children's Institute for Genomic Medicine, Rady Children's Hospital, San Diego, CA 92123, USA; San Diego State University, School of Public Health, San Diego, CA 92182, USA.""}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dimmock', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Caylor', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Gaughran', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Clarke', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Triplett', 'Affiliation': 'The Qualcomm Institute, Calit2, UC San Diego, La Jolla, CA 92093, USA.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Kingsmore', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Cinnamon S', 'Initials': 'CS', 'LastName': 'Bloss', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA 92093, USA; Department of Psychiatry, University of California San Diego, San Diego, CA 92093, USA. Electronic address: cbloss@ucsd.edu.'}]",American journal of human genetics,['10.1016/j.ajhg.2020.10.004']
2304,31238011,A high-salt meal does not augment blood pressure responses during maximal exercise.,"Augmented blood pressure (BP) responses during exercise are predictive of future cardiovascular disease. High dietary sodium (Na + ) increases BP responses during static exercise. It remains unclear if high dietary Na + augments BP responses during dynamic exercise. The purpose of this study was to test the hypothesis that an acute high-Na + meal would augment BP responses during dynamic exercise. Twenty adults (10 male/10 female; age, 26 ± 5 years; BP, 105 ± 10/57 ± 6 mm Hg) were given a high-Na + meal (HSM; 1495 mg Na + ) and a low-Na + meal (LSM; 138 mg Na + ) separated by at least 1 week, in random order. Serum Na + and plasma osmolality were measured. Eighty minutes following the meal, participants completed a graded-maximal exercise protocol on a cycle ergometer. Heart rate, beat-by-beat BP, cardiac output, total peripheral resistance, and manual BP were measured at rest and during exercise. Both serum Na + (HSM: Δ1.6 ± 2.0 vs LSM: Δ1.1 ± 1.8 mmol/L, P = 0.0002) and plasma osmolality (HSM: Δ3.0 ± 4.5 vs LSM: Δ2.0 ± 4.2 mOsm/(kg·H 2 O), P = 0.01) were higher following the HSM. However, the HSM did not augment BP during peak exercise (systolic BP: HSM: 170 ± 23 vs LSM: 171 ± 21 mm Hg, P = 0.81). These findings suggest that an acute high-salt meal does not augment BP responses during dynamic exercise in adults. Novelty The high-salt meal increased serum sodium and plasma osmolality compared with the low-salt meal. The high-salt meal did not augment blood pressure responses during maximal dynamic exercise. This is important as augmented blood pressure responses during exercise put individuals at greater risk for development of cardiovascular disease.",2020,The high-salt meal did not augment blood pressure responses during maximal dynamic exercise.,"['Twenty adults (10 male/10 female; age, 26 ± 5 years; BP, 105 ± 10/57 ± 6 mm Hg']","['HSM', 'high-Na + meal (HSM; 1495 mg Na + ) and a low-Na + meal (LSM; 138 mg Na + ', 'graded-maximal exercise protocol on a cycle ergometer', 'High dietary sodium (Na + ']","['Novelty', 'Heart rate, beat-by-beat BP, cardiac output, total peripheral resistance, and manual BP', 'Serum Na + and plasma osmolality', 'BP responses', 'blood pressure (BP) responses', 'serum sodium and plasma osmolality', 'blood pressure responses', 'plasma osmolality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0037570', 'cui_str': 'Dietary Sodium'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0860721', 'cui_str': 'Plasma osmolality'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}]",,0.0253916,The high-salt meal did not augment blood pressure responses during maximal dynamic exercise.,"[{'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE 19713, USA.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE 19713, USA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE 19713, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE 19713, USA.'}, {'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'Serrador', 'Affiliation': 'Department of Pharmacology, Physiology and Neuroscience, Rutgers University, Newark, NJ 07103, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE 19713, USA.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0217']
2305,31287963,Heart rate variability mediates motivation and fatigue throughout a high-intensity exercise program.,"High-intensity exercise interventions are often promoted as a time-efficient public health intervention to combat chronic disease. However, increased physical effort and subsequent fatigue can be barriers to long-term maintenance of high-intensity exercise programs. The purpose of the present study was to determine if heart rate variability (HRV) mediated state traits related to exercise program adherence. Fifty-five healthy men and women (ages 19-35 years) used a commercially available smartphone application to monitor daily HRV status throughout a 6-week high-intensity exercise intervention. Participants reported state motivation to exercise and global physical fatigue immediately prior to each exercise session. Temporary shifts toward increased parasympathetic reactivation ( p = 0.030) resulted in significant increases in daily fatigue ( p < 0.001) and decreases in motivation to exercise ( p = 0.028). Through modulation of exercise volume, in response to these temporary shifts in HRV, these effects were reversed ( p < 0.001) via increased parasympathetic withdrawal ( p = 0.018). For the first time, these data demonstrate a mediating effect of HRV on adherence-related trait states throughout a high-intensity exercise program. Applied strategies, such as appropriately timed exercise volume moderation, may be able to leverage this effect and help facilitate long-term exercise program maintenance. Novelty These data establish a link between expected shifts in HRV throughout high-intensity exercise programs with motivation to participate and physical fatigue. Modulation of training volume, in response to these shifts, can optimize adherence-related behavioral responses during high-exercise programs.",2020,Temporary shifts toward increased parasympathetic reactivation ( p = 0.030) resulted in significant increases in daily fatigue ( p < 0.001) and decreases in motivation to exercise ( p = 0.028).,['Fifty-five healthy men and women (ages 19-35 years'],"['smartphone application to monitor daily HRV status throughout a 6-week high-intensity exercise intervention', 'High-intensity exercise interventions']","['motivation to exercise', 'state motivation to exercise and global physical fatigue', 'parasympathetic withdrawal', 'physical effort and subsequent fatigue', 'daily fatigue', 'Novelty', 'parasympathetic reactivation']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",55.0,0.0219866,Temporary shifts toward increased parasympathetic reactivation ( p = 0.030) resulted in significant increases in daily fatigue ( p < 0.001) and decreases in motivation to exercise ( p = 0.028).,"[{'ForeName': 'Derek A', 'Initials': 'DA', 'LastName': 'Crawford', 'Affiliation': 'School of Nutrition, Kinesiology and Psychological Science, University of Central Missouri, Warrensburg, MO 64093, USA.'}, {'ForeName': 'Katie M', 'Initials': 'KM', 'LastName': 'Heinrich', 'Affiliation': 'Functional Intensity Training Laboratory, Department of Kinesiology, Kansas State University, Manhattan, KS 66506, USA.'}, {'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Drake', 'Affiliation': 'Applied Physiology Laboratory, Department of Health, Human Performance, & Recreation, Pittsburg State University, Pittsburg, KS 66762, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'DeBlauw', 'Affiliation': 'Functional Intensity Training Laboratory, Department of Kinesiology, Kansas State University, Manhattan, KS 66506, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Carper', 'Affiliation': 'Applied Physiology Laboratory, Department of Health, Human Performance, & Recreation, Pittsburg State University, Pittsburg, KS 66762, USA.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0123']
2306,33155986,ReMindCare App for Early Psychosis: Pragmatic Real World Intervention and Usability Study.,"BACKGROUND
eHealth interventions are widely used in clinical trials and increasingly in care settings as well; however, their efficacy in real-world contexts remains unknown. ReMindCare is a smartphone app that has been systematically implemented in a first episode of psychosis program (FEPP) for patients with early psychosis since 2018.
OBJECTIVE
The objective of this study was to assess the efficacy of ReMindCare after 19 months of use in the clinic and varying use by individual patients.
METHODS
The integration of the ReMindCare app into the FEPP started in October 2018. Patients with early psychosis self-selected to the app (ReMindCare group) or treatment as usual (TAU group). The outcome variables considered were adherence to the intervention and number of relapses, hospital admissions, and visits to urgent care units. Data from 90 patients with early psychosis were analyzed: 59 in the ReMindCare group and 31 in the TAU group. The mean age of the sample was 32.8 (SD 9.4) years, 73% (66/90) were males, 91% (83/90) were White, and 81% (74/90) were single.
RESULTS
Significant differences between the ReMindCare and TAU groups were found in the number of relapses, hospitalizations, and visits to urgent care units, with each showing benefits for the app. Only 20% (12/59) of patients from the ReMindCare group had a relapse, while 58% (18/31) of the TAU patients had one or more relapses (χ 2 =13.7, P=.001). Moreover, ReMindCare patients had fewer visits to urgent care units (χ 2 =7.4, P=.006) and fewer hospitalizations than TAU patients (χ 2 =4.6, P=.03). The mean of days using the app was 352.2 (SD 191.2; min/max: 18-594), and the mean of engagement was 84.5 (SD 16.04).
CONCLUSIONS
To our knowledge, this is the first eHealth intervention that has preliminarily proven its benefits in the real-world treatment of patients with early psychosis.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.1111/eip.12960.",2020,"Moreover, ReMindCare patients had fewer visits to urgent care units (χ 2 =7.4, P=.006) and fewer hospitalizations than TAU patients (χ 2 =4.6, P=.03).","['patients with early psychosis since 2018', '90 patients with early psychosis were analyzed: 59 in the ReMindCare group and 31 in the TAU group', 'The mean age of the sample was 32.8 (SD 9.4) years, 73% (66/90) were males, 91% (83/90) were White, and 81% (74/90) were single', 'Patients with early psychosis self-selected to the app (ReMindCare group) or treatment as usual (TAU group', 'patients with early psychosis']","['ReMindCare', 'ReMindCare and TAU']","['number of relapses, hospitalizations, and visits to urgent care units', 'relapse', 'adherence to the intervention and number of relapses, hospital admissions, and visits to urgent care units', 'visits to urgent care units']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C2362545', 'cui_str': 'Urgent Care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",90.0,0.0295816,"Moreover, ReMindCare patients had fewer visits to urgent care units (χ 2 =7.4, P=.006) and fewer hospitalizations than TAU patients (χ 2 =4.6, P=.03).","[{'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Bonet', 'Affiliation': 'Department of Mental Health, Sanitary Research Institute of Valencia, University Clinic Hospital of Valencia, Valencia, Spain.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Torous', 'Affiliation': 'Division of Digital Psychiatry, Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Arce', 'Affiliation': 'Institute of Instrumentation for Molecular Imaging, Joint Centre of the Spanish National Research Council and Universitat Politècnica de València, Valencia, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Blanquer', 'Affiliation': 'Institute of Instrumentation for Molecular Imaging, Joint Centre of the Spanish National Research Council and Universitat Politècnica de València, Valencia, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Sanjuan', 'Affiliation': 'Department of Mental Health, Sanitary Research Institute of Valencia, University Clinic Hospital of Valencia, Valencia, Spain.'}]",JMIR mHealth and uHealth,['10.2196/22997']
2307,33156128,Assessment of a Novel Lens Surface Treatment for Scleral Lens Wearers With Dry Eye.,"OBJECTIVES
To compare lens comfort and dry eye (DE) symptoms of DE scleral lens (SL) wearers fit with polyethylene glycol (PEG)-based surface-treated and untreated SLs. Dry eye signs, comfortable SL wearing time (WT), vision quality, and lens-related ocular surface changes were also assessed.
METHODS
Twenty-one SL wearers with DE and SL discomfort were enrolled in a double-masked crossover study. Participants were randomized to wear their untreated or PEG (Tangible Hydra-PEG, Tangible Science; Redwood, CA) surface-treated SL of the same parameters first for 30 days. Lens comfort, DE symptoms, and ocular surface assessments were measured at baseline, after the first test period, and after the crossover. Comfortable lens WT and frequency of foggy vision were recorded. Comparisons were assessed using paired t tests or Wilcoxon signed-rank tests.
RESULTS
Polyethylene glycol-treated SL wear resulted in significantly improved: lens comfort (P=0.003), DE symptoms (P=0.004), corneal sodium fluorescein staining (P=0.01), temporal conjunctival lissamine green staining (P=0.01), lid wiper epitheliopathy (P=0.002), conjunctival papillae (P=0.003), frequency of foggy vision (P=0.002), tear break-up time (TBUT) (P=0.01), and comfortable lens WT (P=0.002) compared with untreated wear. There were no significant changes between treated and untreated lens wear for TBUT over the SL (P=0.14) and nasal conjunctival lissamine green staining (P=0.06).
CONCLUSIONS
Polyethylene glycol surface-treated SLs provided improved comfort, reduced DE symptoms, and reduced ocular surface compromise compared with untreated SLs for participants with DE.",2020,"There were no significant changes between treated and untreated lens wear for TBUT over the SL (P=0.14) and nasal conjunctival lissamine green staining (P=0.06).
","['Scleral Lens Wearers With Dry Eye', 'Twenty-one SL wearers with DE and SL discomfort were enrolled in a double-masked crossover study']","['Polyethylene glycol-treated SL', 'DE scleral lens (SL', 'Novel Lens Surface Treatment', 'polyethylene glycol (PEG)-based surface-treated and untreated SLs']","['Dry eye signs, comfortable SL wearing time (WT), vision quality, and lens-related ocular surface changes', 'lid wiper epitheliopathy', 'corneal sodium fluorescein staining', 'temporal conjunctival lissamine green staining', 'Lens comfort, DE symptoms, and ocular surface assessments', 'conjunctival papillae', 'lens comfort and dry eye (DE) symptoms', 'ocular surface compromise', 'frequency of foggy vision', 'tear break-up time (TBUT', ' lens comfort', 'comfort, reduced DE symptoms', 'DE symptoms', 'Comfortable lens WT and frequency of foggy vision', 'nasal conjunctival lissamine green staining']","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0929896', 'cui_str': 'Surface of lens'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0037231', 'cui_str': 'Sjögren-Larsson syndrome'}]","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0147866', 'cui_str': 'Fluorescein sodium stain'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0459667', 'cui_str': 'Conjunctival papilla'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]",,0.0409671,"There were no significant changes between treated and untreated lens wear for TBUT over the SL (P=0.14) and nasal conjunctival lissamine green staining (P=0.06).
","[{'ForeName': 'Chandra V', 'Initials': 'CV', 'LastName': 'Mickles', 'Affiliation': 'Department of Optometry (C.V.M), Nova Southeastern University, Ft. Lauderdale, FL; Illinois College of Optometry (J.S.H.), Chicago, IL; and University of California (M.B.), Davis Eye Center, Sacramento, CA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Harthan', 'Affiliation': ''}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Barnett', 'Affiliation': ''}]",Eye & contact lens,['10.1097/ICL.0000000000000754']
2308,33156201,Alternate Dosing Protocol for Magnesium Sulfate in Obese Women With Preeclampsia: A Randomized Controlled Trial.,"OBJECTIVE
To evaluate whether obese women need greater doses of magnesium sulfate to obtain therapeutic serum concentrations for eclamptic seizure prevention.
METHODS
Women with preeclampsia and a body mass index (BMI) of 35 or higher were randomly allocated to either the Zuspan regimen of magnesium sulfate (4-g intravenous [IV] loading dose, then a 1-g/h infusion) or to alternate dosing (6-g IV loading dose, then a 2-g/h infusion). Women had serum magnesium concentrations obtained at baseline, as well as after administration of magnesium sulfate at 1 hour, 4 hours, and delivery. The primary outcome was the proportion of women who had subtherapeutic serum magnesium concentrations (less than 4.8 mg/dL) 4 hours after administration. A sample size of 18 women per group was planned to compare the proportion of women with subtherapeutic serum magnesium concentrations in each group.
RESULTS
From July 12, 2016, to March 14, 2019, 89 women with preeclampsia were screened and 37 were enrolled: 18 to the Zuspan regimen and 19 to the alternate regimen. A significantly greater proportion of women administered the Zuspan regimen had subtherapeutic serum magnesium concentrations at 4 hours (100% [95% CI 59-100] vs 63% [95% CI 41-81]; P=.01) compared with women administered the alternate higher dose regimen. At 4 hours, mean concentrations were significantly higher in the alternate regimen group (3.53 mg/dL±0.3 [Zuspan regimen] vs 4.41±0.5 [alternate regimen]; P<.01).
CONCLUSION
The alternate dosing regimen of a 6-g IV loading dose followed by a 2-g/h IV maintenance dose more reliably achieves therapeutic serum magnesium concentrations (as defined by a concentration of at least 4.8 mg/dL) in obese women with preeclampsia.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT02835339.",2020,"At 4 hours, mean concentrations were significantly higher in the alternate regimen group (3.53 mg/","['obese women', 'Obese Women With Preeclampsia', 'Women with preeclampsia and a body mass index (BMI) of 35 or higher', 'From July 12, 2016, to March 14, 2019, 89 women with preeclampsia were screened and 37 were enrolled', 'obese women with preeclampsia']","['Zuspan regimen of magnesium sulfate', 'Magnesium Sulfate', 'magnesium sulfate']","['mean concentrations', 'proportion of women who had subtherapeutic serum magnesium concentrations', 'serum magnesium concentrations', 'subtherapeutic serum magnesium concentrations', 'proportion of women with subtherapeutic serum magnesium concentrations', 'therapeutic serum magnesium concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",89.0,0.455186,"At 4 hours, mean concentrations were significantly higher in the alternate regimen group (3.53 mg/","[{'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Brookfield', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, Oregon; and the Department of Anesthesia, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Kierstyn', 'Initials': 'K', 'LastName': 'Tuel', 'Affiliation': ''}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Rincon', 'Affiliation': ''}, {'ForeName': 'Abbie', 'Initials': 'A', 'LastName': 'Vinson', 'Affiliation': ''}, {'ForeName': 'Aaron B', 'Initials': 'AB', 'LastName': 'Caughey', 'Affiliation': ''}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Carvalho', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004137']
2309,33156242,Serum Levels of Branched Chain Amino Acids Predict Duration of Cardiovascular Organ Failure in Septic Shock.,"BACKGROUND
Sepsis shifts cardiac metabolic fuel preference and this disruption may have implications for cardiovascular function. A greater understanding of the role of metabolism in the development and persistence of cardiovascular failure in sepsis could serve to identify novel pharmacotherapeutic approaches.
METHODS
Secondary analysis of prospective quantitative H-NMR metabolomic data from patients enrolled in a phase II randomized control trial of L-carnitine in septic shock. Participants with a SOFA score of > = 5, lactate > = 2, and requiring vasopressor support for at least 4 hours were eligible for enrollment. The independent prognostic value of metabolites to predict a) survival with shock resolution within 48 hours and b) vasopressor free days were assessed. Concentrations of predictive metabolites were compared between participants with and without shock resolution at 48 hours.
RESULTS
Serum H-NMR metabolomics data from 228 patients were analyzed. 81 (36%) patients met the primary outcome; 33 (14%) died prior to 48 hours. The branched chain amino acids (BCAA), valine, leucine, and isoleucine were univariate predictors of the primary outcome after adjusting for multiple hypothesis testing, while valine remained significant after controlling for SOFA score. Similar results were observed when analyzed based on vasopressor free days, and persisted after controlling for confounding variables and excluding non-survivors. BCAA concentrations at 48 hours significantly discriminated between those with shock resolution versus persistent shock.
CONCLUSIONS
Among patients with septic shock, BCAA concentrations independently predict time to shock resolution. This study provides hypothesis generating data into the potential contribution of BCAAs to the pathophysiology of cardiovascular failure in sepsis, opening areas for future investigations.",2020,"BCAA concentrations at 48 hours significantly discriminated between those with shock resolution versus persistent shock.
","['in septic shock', '228 patients were analyzed', 'Participants with a SOFA score of >\u200a=\u200a5, lactate >\u200a=\u200a2, and requiring vasopressor support for at least 4\u200ahours were eligible for enrollment']",['L-carnitine'],"['BCAA concentrations', 'Concentrations of predictive metabolites']","[{'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}]","[{'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",228.0,0.511873,"BCAA concentrations at 48 hours significantly discriminated between those with shock resolution versus persistent shock.
","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Puskarich', 'Affiliation': 'Department of Emergency Medicine, University of Minnesota and the.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'McHugh', 'Affiliation': 'The NMR Metabolomics Laboratory and the Department of Clinical Pharmacy, College of Pharmacy.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Flott', 'Affiliation': 'The NMR Metabolomics Laboratory and the Department of Clinical Pharmacy, College of Pharmacy.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Karnovsky', 'Affiliation': 'Michigan Regional Comprehensive Metabolomics Resource Core ((MRC)).'}, {'ForeName': 'Alan E', 'Initials': 'AE', 'LastName': 'Jones', 'Affiliation': 'Department of Emergency Medicine, University of Mississippi Medical Center, Jackson, MS.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Stringer', 'Affiliation': 'The NMR Metabolomics Laboratory and the Department of Clinical Pharmacy, College of Pharmacy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Shock (Augusta, Ga.)",['10.1097/SHK.0000000000001687']
2310,33156354,Combining fracture outcomes in phase 3 trials of osteoporosis: an analysis of the effects of denosumab in postmenopausal women.,"This paper explores use of metrics that combine fracture outcomes that add power to phase 3 studies and provide a surrogate outcome for regulatory agencies.
INTRODUCTION
The aim of this study was to develop an analytic framework that would combine information from all fracture outcomes (including radiographic vertebral fractures) in phase 3 studies to provide a metric for the assessment of treatment efficacy.
METHODS
Data from the phase 3 study of denosumab were used as an exemplar comparing the effects of active intervention with placebo on the risk of all fractures associated with osteoporosis. Fracture outcomes were assigned utility weights drawn from the published literature and applied to age-specific health state values of the general population. For each fracture outcome in each arm of the study, cumulative disutility was computed to serve as the principal end point. The hypothesis tested was that treatment with denosumab results in a significant reduction in mean fracture-related disutility.
RESULTS
Treatment with denosumab was associated with significantly lower utility loss compared with placebo. For patients treated with denosumab, mean utility loss was 42% less than with placebo (4.5 vs. 7.5 QALYs/1000 patient years, respectively, p < 0.001).
CONCLUSIONS
Denosumab significantly decreased utility loss. The use of metrics that combine fracture outcomes may provide added power to phase 3 studies and provide a surrogate outcome for regulatory agencies.",2020,"For patients treated with denosumab, mean utility loss was 42% less than with placebo (4.5 vs. 7.5 QALYs/1000 patient years, respectively, p < 0.001).
",['postmenopausal women'],"['placebo', 'denosumab']","['mean fracture-related disutility', 'mean utility loss', 'utility loss']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0519757,"For patients treated with denosumab, mean utility loss was 42% less than with placebo (4.5 vs. 7.5 QALYs/1000 patient years, respectively, p < 0.001).
","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Kanis', 'Affiliation': 'Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia. w.j.pontefract@shef.ac.uk.'}, {'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Harvey', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lorentzon', 'Affiliation': 'Geriatric Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': 'Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vandenput', 'Affiliation': 'Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'McCloskey', 'Affiliation': 'Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': 'Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05699-0']
2311,33156372,High-intensity interval training and active video gaming improve neurocognition in schizophrenia: a randomized controlled trial.,"There is a need for treatments targeting neurocognitive dysfunctions in schizophrenia. The aim of this study was to investigate the neurocognitive effect of aerobic high-intensity interval training (HIIT). A comparison group performed sport simulating active video gaming (AVG). We anticipated that HIIT would improve neurocognition beyond any effect of AVG, due to engagement in higher intensity cardiorespiratory demands. Recent research on the beneficial neurocognitive effect of AVG challenges this expectation but added new relevance to comparing the two interventions. This is an observer-blinded randomized controlled trial. Eighty-two outpatients diagnosed with schizophrenia were allocated to HIIT (n = 43) or AVG (n = 39). Both groups received two supervised sessions per week for 12 weeks. The attrition rate was 31%, and 65% of the participants were defined as protocol compliant study completers. Intention-to-treat analyses showed significant improvements in the neurocognitive composite score from baseline to post-intervention and from baseline to 4 months follow-up in the total sample. The same pattern of results was found in several subdomains. Contrary to our hypothesis, we found no interaction effects of time and group, indicating equal effects in both groups. Separate within-group analysis unexpectedly showed trends of differential effects in the learning domain, as HIIT showed post-intervention improvement in verbal but not visual learning, while AVG showed improvement in visual but not verbal learning. HIIT and AVG improve neurocognition equally, suggesting that both interventions may be applied to target neurocognition in schizophrenia. Future research should investigate trends towards possible differential effects of exercise modes on neurocognitive subdomains. NCT02205684, 31.07.14.",2020,Intention-to-treat analyses showed significant improvements in the neurocognitive composite score from baseline to post-intervention and from baseline to 4 months follow-up in the total sample.,"['Eighty-two outpatients diagnosed with schizophrenia', 'schizophrenia']","['aerobic high-intensity interval training (HIIT', 'AVG', 'sport simulating active video gaming (AVG', 'High-intensity interval training and active video gaming']","['neurocognitive composite score', 'visual but not verbal learning', 'attrition rate']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",82.0,0.0633077,Intention-to-treat analyses showed significant improvements in the neurocognitive composite score from baseline to post-intervention and from baseline to 4 months follow-up in the total sample.,"[{'ForeName': 'Gry', 'Initials': 'G', 'LastName': 'Bang-Kittilsen', 'Affiliation': 'Division of Mental Health and Addiction, Vestfold Hospital Trust, Mail Office Box 2168, 3103, Tønsberg, Norway. gry.bang-kittilsen@siv.no.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Egeland', 'Affiliation': 'Division of Mental Health and Addiction, Vestfold Hospital Trust, Mail Office Box 2168, 3103, Tønsberg, Norway.'}, {'ForeName': 'Tom Langerud', 'Initials': 'TL', 'LastName': 'Holmen', 'Affiliation': 'Division of Mental Health and Addiction, Vestfold Hospital Trust, Mail Office Box 2168, 3103, Tønsberg, Norway.'}, {'ForeName': 'Therese Torgersen', 'Initials': 'TT', 'LastName': 'Bigseth', 'Affiliation': 'Division of Mental Health and Addiction, Vestfold Hospital Trust, Mail Office Box 2168, 3103, Tønsberg, Norway.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Andersen', 'Affiliation': 'Faculty of Humanities, Sports and Educational Science, University of Southeast Norway, Horten, Norway.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Mordal', 'Affiliation': 'Division of Mental Health and Addiction, Vestfold Hospital Trust, Mail Office Box 2168, 3103, Tønsberg, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Ulleberg', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'John Abel', 'Initials': 'JA', 'LastName': 'Engh', 'Affiliation': 'Division of Mental Health and Addiction, Vestfold Hospital Trust, Mail Office Box 2168, 3103, Tønsberg, Norway.'}]",European archives of psychiatry and clinical neuroscience,['10.1007/s00406-020-01200-4']
2312,33156402,Intranasal oxytocin decreases self-oriented learning.,"RATIONALE
Oxytocin has been found to play an important role in human social cognition and social interaction. Over the last two decades, surge studies have been conducted to investigate how oxytocin impacts other-oriented processes, such as trust and generosity (Zak et al. in PLoS ONE 2(11):e1128, 2007); however, the examination of the effect of oxytocin on self-related processes was relatively inadequate. Appropriate and efficient social interactions require both self- and other-related information processing. Recent studies have found that intranasal oxytocin (IN-OT) influences the self-related process, although the results have been mixed. The computational process underlying the effects of IN-OT on self-processing remains unknown.
OBJECTIVES
We aim to investigate the effect of IN-OT on self-oriented learning across different contexts (self-other independent vs. self-other dependent) and uncover the process by which IN-OT affects dynamic behavior changes.
METHODS
We performed two double-blind, placebo-controlled studies and used reinforcement learning theory to integrate action and related feedback for participants' behaviors.
RESULTS
In study 1, IN-OT decreased self-oriented reward learning when self-oriented learning and prosocial (other-oriented) learning were assessed separately. These effects were partially due to the OT-related increase in choice variability during self-oriented learning. In study 2, IN-OT also decreased learning performance during self-oriented reward learning when self-related and other-related rewards were present together. These effects occurred at an early stage of the learning process and could be moderated by the participants' social value orientation. Our findings show that OT attenuates the process of self-oriented learning and provides an underlying computational process.
CONCLUSIONS
Our findings shed new light on the dynamics of IN-OT's effects on human self-oriented learning processes. For future studies on OT effects on self-oriented learning, individual factors such as social value orientation should be taken into consideration in research development and analysis.",2020,These effects occurred at an early stage of the learning process and could be moderated by the participants' social value orientation.,"[""participants' behaviors""]","['intranasal oxytocin (IN-OT', 'oxytocin', 'placebo', 'OT', 'Intranasal oxytocin']","['self-oriented reward learning', 'learning performance']","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0582590', 'cui_str': 'Learning performance'}]",,0.0231397,These effects occurred at an early stage of the learning process and could be moderated by the participants' social value orientation.,"[{'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department of Psychology, Guangdong Provincial Key Laboratory of Social Cognitive Neuroscience and Mental Health, Guangdong Provincial Key Laboratory of Brain Function and Disease, Sun Yat-Sen University, Guangzhou, 510006, China.'}, {'ForeName': 'Liqin', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Psychology, Guangdong Provincial Key Laboratory of Social Cognitive Neuroscience and Mental Health, Guangdong Provincial Key Laboratory of Brain Function and Disease, Sun Yat-Sen University, Guangzhou, 510006, China.'}, {'ForeName': 'Siyang', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'Department of Psychology, Guangdong Provincial Key Laboratory of Social Cognitive Neuroscience and Mental Health, Guangdong Provincial Key Laboratory of Brain Function and Disease, Sun Yat-Sen University, Guangzhou, 510006, China. Luosy6@mail.sysu.edu.cn.'}]",Psychopharmacology,['10.1007/s00213-020-05694-7']
2313,32536109,Effects of twelve weeks' aerobic training on motor cortex excitability.,"BACKGROUND
Regular physical activity or aerobic exercise is well known to increase brain plasticity. Recent studies have reported that aerobic exercise enhances neuroplasticity and motor learning. The aim of this study was to investigate if 12 weeks' aerobic training can modify cortical excitability and motor evoked potential (MEP) responses.
METHODS
Fifteen untrained males were recruited. Cortical excitability was investigated using TMS. VO2max was estimated using Cooper's test. Aerobic intervention lasted 12 weeks. The subjects performed a 6-week supervised aerobic workout, 3 times a week, at 60-75% of their maximum heart rate (HRmax). Over the following 6 weeks, they performed a supervised aerobic workout 3 times a week at 70-75% of FCmax.
RESULTS
After 8 weeks of aerobic training there was a significant increase of distance covered during Cooper's test (P<0.001) and a significant increase of VO2max (P<0.001); there was also an improvement in resting motor threshold (rMT decreased from 60.5±6.6% [T0] to 55.8±5.9% [T2]; P<0.001), motor evoked potential latency decreased (from 25.3±0.8 ms [T0] to 24.1±0.8 ms [T2]; P<0.001), and motor evoked potential amplitude increased (from 0.58±0.09 mV [T0] to 0.65±0.08 mV [T2]; P<0.001). Furthermore, after 12 weeks' aerobic training there were improvements in all parameters.
CONCLUSIONS
This study shows that aerobic activity seems to induce changes in cortical excitability if performed for a period longer than 4 weeks, in addition to typical cardiorespiratory benefits in previously untrained males.",2020,After 8 weeks of aerobic training there was a significant increase of distance covered during Cooper's test (P<0.001) and a significant increase of VO2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0027446', 'cui_str': 'National Academy of Sciences (U.S.)'}, {'cui': 'C0441763', 'cui_str': 'Stage 0'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517786', 'cui_str': '475'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C3714811', 'cui_str': 'Resolved'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",227.0,0.0523093,"The diagnostic performance of NIS4 within the external validation cohorts was not influenced by age, sex, BMI, or aminotransferase concentrations.
","[{'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Summit Clinical Research, San Antonio, TX, USA; Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Ratziu', 'Affiliation': 'Sorbonne Université, Institute for Cardiometabolism and Nutrition, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Boursier', 'Affiliation': ""Service d'Hépato-Gastroentérologie, Centre Hospitalier Universitaire d'Angers, Angers, France; Laboratoire HIFIH, UPRES EA3859, SFR 4208, Université d'Angers, Angers, France.""}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Francque', 'Affiliation': 'Department of Gastroenterology and Hepatology, Antwerp University Hospital, Antwerp, Belgium; Translational Sciences in Inflammation and Immunology & InflaMed Consortium of Excellence, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bedossa', 'Affiliation': 'Liverpat, Paris, France; Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Zouher', 'Initials': 'Z', 'LastName': 'Majd', 'Affiliation': 'Genfit, Loos, France.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Cordonnier', 'Affiliation': 'Genfit, Loos, France.'}, {'ForeName': 'Fouad Ben', 'Initials': 'FB', 'LastName': 'Sudrik', 'Affiliation': 'Genfit, Loos, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Darteil', 'Affiliation': 'Genfit, Loos, France; ENYO Pharma, Lyon, France.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Liebe', 'Affiliation': 'Genfit, Loos, France; Klinik für Gastroenterologie, Hepatologie und Infektiologie, Universitätsklinikum Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Jérémy', 'Initials': 'J', 'LastName': 'Magnanensi', 'Affiliation': 'Genfit, Loos, France.'}, {'ForeName': 'Yacine', 'Initials': 'Y', 'LastName': 'Hajji', 'Affiliation': 'Genfit, Loos, France.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brozek', 'Affiliation': 'Genfit, Loos, France.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Roudot', 'Affiliation': 'Genfit, Loos, France.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Staels', 'Affiliation': 'Université de Lille, Inserm, CHU Lille, Institut Pasteur de Lille, U1011 - EGID, F-59000 Lille, France.'}, {'ForeName': 'Dean W', 'Initials': 'DW', 'LastName': 'Hum', 'Affiliation': 'Genfit, Loos, France.'}, {'ForeName': 'Sophie Jeannin', 'Initials': 'SJ', 'LastName': 'Megnien', 'Affiliation': 'Summit Clinical Research, San Antonio, TX, USA; Genfit, Loos, France.'}, {'ForeName': 'Suneil', 'Initials': 'S', 'LastName': 'Hosmane', 'Affiliation': 'Genfit, Loos, France.'}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Dam', 'Affiliation': 'Genfit, Loos, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Chaumat', 'Affiliation': 'Genfit, Loos, France.'}, {'ForeName': 'Rémy', 'Initials': 'R', 'LastName': 'Hanf', 'Affiliation': 'Genfit, Loos, France. Electronic address: remy.hanf@genfit.com.'}, {'ForeName': 'Quentin M', 'Initials': 'QM', 'LastName': 'Anstee', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK; Newcastle NIHR Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University School of Medicine, Richmond, VA, USA.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30252-1']
2315,32778491,Editor's Choice - Relationship Between Global Limb Anatomic Staging System (GLASS) and Clinical Outcomes Following Revascularisation for Chronic Limb Threatening Ischaemia in the Bypass Versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 Trial.,"OBJECTIVE
The Global Vascular Guideline on chronic limb threatening ischaemia (CLTI) has introduced the Global Limb Anatomic Staging System (GLASS) as a new angiographic scoring system. However, the relationship between GLASS and outcomes following revascularisation has not previously been studied.
METHODS
Using pre-intervention angiograms the relationship between GLASS and immediate technical failure (ITF), amputation free survival (AFS), limb salvage (LS), overall survival (OS), and freedom from major adverse limb events (FF-MALE) was examined in 377 patients undergoing endovascular therapy (EVT, n = 213) or bypass surgery (BS, n = 164) in the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 trial (randomised 1999-2004).
RESULTS
There was no significant difference in GLASS between cohorts. There was a significant relationship between ITF and GLASS in EVT (I 14%, II 15%, III 28%, p = .049). GLASS was significantly related to AFS (hazard ratio [HR], 1.37; 95% CI 1.01-1.85; p = .042), LS (HR 1.96; 95 % CI 1.12-3.43; p = .018), and FF-MALE (HR 1.49; 95% CI 1.04-1.87; p = .028) in the EVT cohort. In BS patients, there was no relationship between GLASS and these outcomes. FF-MALE was significantly worse after EVT than BS in GLASS II (p = .038) and III (p = .001). Among the subgroup of patients with femoropopliteal (FP) disease (BS, n = 109 or EVT, n = 159), FF-MALE was significantly higher after BS than EVT (p < .001). The superiority of BS over EVT with increasing GLASS FP grade was greater in the analysis of patients using vein grafts.
CONCLUSION
In the BASIL-1 cohort, GLASS is associated with outcomes following EVT but not BS. Although further validation in contemporary CLTI cohorts is required, GLASS seems likely be useful in shared decision making and for stratifying patients in future trials.",2020,FF-MALE was significantly worse after EVT than BS in GLASS II (p = .038) and III (p = .001).,"['377 patients undergoing endovascular therapy (EVT, n\xa0=\xa0213) or bypass surgery (BS, n\xa0=\xa0164) in the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 trial (randomised 1999-2004', 'chronic limb threatening ischaemia (CLTI', 'Chronic Limb Threatening Ischaemia in the Bypass Versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 Trial']","['Global Limb Anatomic Staging System (GLASS', 'GLASS']","['ITF and GLASS in EVT', 'GLASS and immediate technical failure (ITF), amputation free survival (AFS), limb salvage (LS), overall survival (OS), and freedom from major adverse limb events (FF-MALE', 'FF-MALE', 'GLASS FP grade']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0449394', 'cui_str': 'Staging system'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0449394', 'cui_str': 'Staging system'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0949591', 'cui_str': 'Limb Salvage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",377.0,0.223117,FF-MALE was significantly worse after EVT than BS in GLASS II (p = .038) and III (p = .001).,"[{'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Kodama', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Nagoya University Graduate School of Medicine, Japan. Electronic address: akodama@med.nagoya-u.ac.jp.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Meecham', 'Affiliation': 'Department of Vascular Surgery, University of Birmingham, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Popplewell', 'Affiliation': 'Department of Vascular Surgery, University of Birmingham, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Bate', 'Affiliation': 'Department of Vascular Surgery, University of Birmingham, UK.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Conte', 'Affiliation': 'Department of Surgery, University of California at San Francisco, CA, USA.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Bradbury', 'Affiliation': 'Department of Vascular Surgery, University of Birmingham, UK.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.06.042']
2316,31476159,"Association Between Insulin Resistance, Plasma Leptin, and Neurocognition in Vascular Cognitive Impairment.","BACKGROUND
Greater body weight has been associated impairments in neurocognition and greater dementia risk, although the mechanisms linking weight and neurocognition have yet to be adequately delineated.
OBJECTIVE
To examine metabolic mechanisms underlying the association between obesity and neurocognition.
METHODS
We conducted a secondary analysis of weight, neurocognition, and the potentially mediating role of metabolic and inflammatory biomarkers among 160 participants from the ENLIGHTEN trial of vascular cognitive impairment, no dementia (CIND). Neurocognition was assessed using a 45-minute assessment battery assessing Executive Function, Verbal and Visual Memory. We considered three metabolic biomarkers: insulin resistance (homeostatic model assessment [HOMA-IR]), plasma leptin, and insulin-like growth factor (IGF-1). Inflammation was assessed using C-reactive protein. Multiple regression analyses were used.
RESULTS
Participants included 160 sedentary older adults with CIND. Participants tended to be overweight or obese (mean BMI = 32.5 [SD = 4.8]). Women exhibited higher BMI (p = 0.043), CRP (p < 0.001), and leptin (p < 0.001) compared with men. Higher BMI levels were associated with worse performance on measures of Executive Function (β= -0.16, p = 0.024) and Verbal Memory (β= -0.16, p = 0.030), but not Visual Memory (β= 0.05, p = 0.500). Worse metabolic biomarker profiles also were associated with lower Executive Function (β= -0.12, p = 0.050). Mediation analyses suggested leptin was a plausible candidate as a mediator between BMI and Executive Function.
CONCLUSIONS
In overweight and obese adults with vascular CIND, the association between greater weight and poorer executive function may be mediated by higher leptin resistance.",2019,"Higher BMI levels were associated with worse performance on measures of Executive Function (β= -0.16, p = 0.024) and Verbal Memory (β= -0.16, p = 0.030), but not Visual Memory (β= 0.05, p = 0.500).","['160 participants from the ENLIGHTEN trial of vascular cognitive impairment, no dementia (CIND', 'Participants included 160 sedentary older adults with CIND', 'Participants tended to be overweight or obese (mean BMI\u200a=\u200a32.5 [SD\u200a=\u200a4.8']",[],"['BMI', 'Insulin Resistance, Plasma Leptin, and Neurocognition in Vascular Cognitive Impairment', 'Higher BMI levels', 'Inflammation', 'Verbal Memory', 'metabolic biomarkers: insulin resistance (homeostatic model assessment [HOMA-IR]), plasma leptin, and insulin-like growth factor (IGF-1', 'leptin', 'CRP', 'Executive Function', 'lower Executive Function', '45-minute assessment battery assessing Executive Function, Verbal and Visual Memory']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3805043', 'cui_str': 'Vascular cognitive impairment'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C4517765', 'cui_str': '4.8'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C3805043', 'cui_str': 'Vascular cognitive impairment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}]",160.0,0.0282987,"Higher BMI levels were associated with worse performance on measures of Executive Function (β= -0.16, p = 0.024) and Verbal Memory (β= -0.16, p = 0.030), but not Visual Memory (β= 0.05, p = 0.500).","[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mabe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sherwood', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Babyak', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'P Murali', 'Initials': 'PM', 'LastName': 'Doraiswamy', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Welsh-Bohmer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Kraus', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Burke', 'Affiliation': 'Department of Neurology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Hinderliter', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Blumenthal', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190569']
2317,31727687,Novel Biomarkers for Change in Renal Function in People With Dysglycemia.,"OBJECTIVE
Diabetes is a major risk factor for renal function decline and failure. The availability of multiplex panels of biochemical markers provides the opportunity to identify novel biomarkers that can better predict changes in renal function than routinely available clinical markers.
RESEARCH DESIGN AND METHODS
The concentration of 239 biochemical markers was measured in stored serum from participants in the biomarker substudy of Outcome Reduction With Initial Glargine Intervention (ORIGIN) trial. Repeated-measures mixed-effects models were used to compute the annual change in eGFR (measured as mL/min/1.73 m 2 /year) for the 7,482 participants with a recorded baseline and follow-up eGFR. Linear regression models using forward selection were used to identify the independent biomarker determinants of the annual change in eGFR after accounting for baseline HbA 1c , baseline eGFR, and routinely measured clinical risk factors. The incidence of the composite renal outcome (i.e., renal replacement therapy, renal death, renal failure, albuminuria progression, doubling of serum creatinine) and death within each fourth of change in eGFR predicted from these models was also estimated.
RESULTS
During 6.2 years of median follow-up, the median annual change in eGFR was -0.18 mL/min/1.73 m 2 /year. Fifteen biomarkers independently predicted eGFR decline after accounting for cardiovascular risk factors, as did 12 of these plus 1 additional biomarker after accounting for renal risk factors. Every 0.1 mL/min/1.73 m 2 predicted annual fall in eGFR predicted a 13% (95% CI 12, 14%) higher mortality.
CONCLUSIONS
Adding up to 16 biomarkers to routinely measured clinical risk factors improves the prediction of annual change in eGFR in people with dysglycemia.",2020,"Fifteen biomarkers independently predicted eGFR decline after accounting for cardiovascular risk factors, as did 12 of these plus 1 additional biomarker after accounting for renal risk factors.","['7,482 participants with a recorded baseline and follow-up eGFR', 'People With Dysglycemia', 'people with dysglycemia']",['Initial Glargine Intervention'],"['composite renal outcome (i.e., renal replacement therapy, renal death, renal failure, albuminuria progression, doubling of serum creatinine) and death within each fourth of change in eGFR', 'median annual change in eGFR', 'mortality', 'concentration of 239 biochemical markers']","[{'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1960636', 'cui_str': 'Dysglycemia'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}]",7482.0,0.0837774,"Fifteen biomarkers independently predicted eGFR decline after accounting for cardiovascular risk factors, as did 12 of these plus 1 additional biomarker after accounting for renal risk factors.","[{'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada gerstein@mcmaster.ca.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Paré', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'McQueen', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Shun Fu', 'Initials': 'SF', 'LastName': 'Lee', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Shrikant I', 'Initials': 'SI', 'LastName': 'Bangdiwala', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Aimo', 'Initials': 'A', 'LastName': 'Kannt', 'Affiliation': 'Sanofi Aventis Deutschland GmbH Research and Development, Frankfurt, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Hess', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-1604']
2318,32941499,"Maternal-fetal bonding among pregnant women at psychosocial risk: The roles of adult attachment style, prenatal parental reflective functioning, and depressive symptoms.","Pregnancy offers a unique period for initiating preventive parenting interventions. Disturbances in maternal-fetal bonding may indicate suboptimal parenting and a need for intervention. However, more knowledge is needed on the development of maternal-fetal bonding among at-risk groups. The study aim was to examine psychosocial correlates of maternal-fetal bonding among pregnant women identified to be at risk socially and regarding their mental health. The sample consisted of 78 at-risk pregnant women participating in a perinatal intervention study: Godt på Vej Sammen [A Good Start to Life-an Early Cross-sectorial Intervention]. This study was cross-sectional reporting on the baseline characteristics of the participants. In the beginning of the second trimester, participants completed questionnaires assessing maternal-fetal bonding (the Maternal Antenatal Attachment Scale [MAAS]), prenatal parental reflective functioning, adult attachment style, and depressive symptoms. We compared the distribution of MAAS styles with norms from a recent Dutch community sample. In addition, we tested associations between psychosocial variables and the quality and intensity of MAAS scores in regression models and performed Chi-square analyses to assess the association of MAAS styles with psychosocial variables. First, compared to women from a community sample, approximately half of the women in our sample presented lower and suboptimal MAAS scores. Second, insecure avoidant adult attachment style was negatively associated with MAAS intensity, and depressive symptoms were negatively associated with MAAS quality. Third, prenatal parental reflective functioning positively correlated with both quality and intensity of MAAS. Fourth, we found no association between insecure anxious adult attachment style and MAAS scores. Fifth, women with a negative disinterested MAAS style demonstrated the highest avoidant attachment scores, while women with a positively preoccupied MAAS style demonstrated the highest prenatal parental reflective functioning scores. The results suggest that there is a need to differentiate among at-risk pregnant woman and that prenatal screening using the MAAS may help identify those who need preventive parenting interventions and what those interventions should focus on. A main limitation of the study is the lack of a representative group of at-risk pregnant women which limits the generalizability of the study results to all risk groups.",2020,The sample consisted of 78 at-risk pregnant women participating in a perinatal intervention study:,"['pregnant women identified to be at risk socially and regarding their mental health', '78 at-risk pregnant women participating in a perinatal intervention study', 'pregnant women at psychosocial risk']",['Godt på Vej Sammen'],"['quality and intensity of MAAS', 'highest avoidant attachment scores', 'quality and intensity of MAAS scores', 'suboptimal MAAS scores', 'MAAS intensity, and depressive symptoms', 'adult attachment style, prenatal parental reflective functioning, and depressive symptoms', 'questionnaires assessing maternal-fetal bonding (the Maternal Antenatal Attachment Scale [MAAS]), prenatal parental reflective functioning, adult attachment style, and depressive symptoms', 'insecure anxious adult attachment style and MAAS scores']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",[],"[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0348228,The sample consisted of 78 at-risk pregnant women participating in a perinatal intervention study:,"[{'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Røhder', 'Affiliation': 'Center for Clinical Research and Prevention, Frederiksberg Hospital, Capital Region of Denmark, Copenhagen, Denmark.'}, {'ForeName': 'Mette Skovgaard', 'Initials': 'MS', 'LastName': 'Væver', 'Affiliation': 'Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Kristine', 'Initials': 'AK', 'LastName': 'Aarestrup', 'Affiliation': 'Center for Clinical Research and Prevention, Frederiksberg Hospital, Capital Region of Denmark, Copenhagen, Denmark.'}, {'ForeName': 'Rikke Kart', 'Initials': 'RK', 'LastName': 'Jacobsen', 'Affiliation': 'Center for Clinical Research and Prevention, Frederiksberg Hospital, Capital Region of Denmark, Copenhagen, Denmark.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Smith-Nielsen', 'Affiliation': 'Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Michaela L', 'Initials': 'ML', 'LastName': 'Schiøtz', 'Affiliation': 'Center for Clinical Research and Prevention, Frederiksberg Hospital, Capital Region of Denmark, Copenhagen, Denmark.'}]",PloS one,['10.1371/journal.pone.0239208']
2319,33157007,"An RCT of Rapid Genomic Sequencing among Seriously Ill Infants Results in High Clinical Utility, Changes in Management, and Low Perceived Harm.","The second Newborn Sequencing in Genomic Medicine and Public Health (NSIGHT2) study was a randomized, controlled trial of rapid whole-genome sequencing (rWGS) or rapid whole-exome sequencing (rWES) in infants with diseases of unknown etiology in intensive care units (ICUs). Gravely ill infants were not randomized and received ultra-rapid whole-genome sequencing (urWGS). Herein we report results of clinician surveys of the clinical utility of rapid genomic sequencing (RGS). The primary end-point-clinician perception that RGS was useful- was met for 154 (77%) of 201 infants. Both positive and negative tests were rated as having clinical utility (42 of 45 [93%] and 112 of 156 [72%], respectively). Physicians reported that RGS changed clinical management in 57 (28%) infants, particularly in those receiving urWGS (p = 0.0001) and positive tests (p < 0.00001). Outcomes of 32 (15%) infants were perceived to be changed by RGS. Positive tests changed outcomes more frequently than negative tests (p < 0.00001). In logistic regression models, the likelihood that RGS was perceived as useful increased 6.7-fold when associated with changes in management (95% CI 1.8-43.3). Changes in management were 10.1-fold more likely when results were positive (95% CI 4.7-22.4) and turnaround time was shorter (odds ratio 0.92, 95% CI 0.85-0.99). RGS seldom led to clinician-perceived confusion or distress among families (6 of 207 [3%]). In summary, clinicians perceived high clinical utility and low likelihood of harm with first-tier RGS of infants in ICUs with diseases of unknown etiology. RGS was perceived as beneficial irrespective of whether results were positive or negative.",2020,"Both positive and negative tests were rated as having clinical utility (42 of 45 [93%] and 112 of 156 [72%], respectively).","['Gravely ill infants', 'infants with diseases of unknown etiology in intensive care units (ICUs']","['rapid whole-genome sequencing (rWGS) or rapid whole-exome sequencing (rWES', 'rapid genomic sequencing (RGS', 'ultra-rapid whole-genome sequencing (urWGS']","['turnaround time', 'RGS changed clinical management']","[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C3640076', 'cui_str': 'Whole genome sequencing'}, {'cui': 'C3640077', 'cui_str': 'Complete Exome Sequencing'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",,0.111788,"Both positive and negative tests were rated as having clinical utility (42 of 45 [93%] and 112 of 156 [72%], respectively).","[{'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dimmock', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA. Electronic address: ddimmock@rchsd.org.""}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Gaughran', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Cakici', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA; Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA 92093, USA.""}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Caylor', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Clarke', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Feddock', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Shimul', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Salz', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Cheung', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA 92093, USA; Department of Psychiatry, University of California San Diego, San Diego, CA 92093, USA.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Bird', 'Affiliation': ""Rady Children's Hospital, San Diego, CA 92123, USA; Department of Pediatrics, University of California San Diego, San Diego, CA 92093, USA.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hobbs', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Wigby', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA; Department of Pediatrics, University of California San Diego, San Diego, CA 92093, USA.""}, {'ForeName': 'Lauge', 'Initials': 'L', 'LastName': 'Farnaes', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Cinnamon S', 'Initials': 'CS', 'LastName': 'Bloss', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA 92093, USA; Department of Psychiatry, University of California San Diego, San Diego, CA 92093, USA.'}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Kingsmore', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of human genetics,['10.1016/j.ajhg.2020.10.003']
2320,33157077,"Long-Term Safety and Efficacy of Adalimumab in Patients With Noninfectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis.","PURPOSE
To evaluate long-term efficacy and safety of extended treatment with adalimumab in patients with noninfectious intermediate, posterior, or panuveitis.
DESIGN
Open-label, multicenter, phase 3 extension study (VISUAL III).
PARTICIPANTS
Adults who had completed a randomized, placebo-controlled phase 3 parent trial (VISUAL I or II) without treatment failure (inactive uveitis) or discontinued after meeting treatment failure criteria (active uveitis).
METHODS
Patients received subcutaneous adalimumab 40 mg every other week. Data were collected for ≤362 weeks. Adverse events (AEs) were recorded until 70 days after the last dose of study drug.
MAIN OUTCOME MEASURES
Main outcome measures were long-term safety and quiescence; other efficacy variables included inflammatory lesions, anterior chamber cell and vitreous haze grade, macular edema, visual acuity, and dose of uveitis-related corticosteroids.
RESULTS
Of 424 patients enrolled, 67% (283/424) had active uveitis and 33% (141/424) had inactive uveitis at study entry; 60 patients subsequently met exclusion criteria, and 364 patients were included in the intent-to-treat analysis. Efficacy variables were analyzed through week 150 when approximately 50% of patients (214/424) remained in the study. The percentage of patients in quiescence increased from 34% (122/364) at week 0 to 85% (153/180) at week 150. Corticosteroid-free quiescence was achieved by 54% (66/123) and 89% (51/57) of patients with active or inactive uveitis at study entry, respectively, by week 150. Mean daily dose of corticosteroids was reduced from 9.4±17.1 mg/day at week 0 (n=359) to 1.5±3.9 mg/day at week 150 (n=181). The percentage of patients who achieved other efficacy variables increased over time for those with active uveitis at study entry and was maintained for those with inactive uveitis. The most frequently reported treatment-emergent AEs of special interest for adalimumab were infections (n=275; 78.7 events/100 patient-years); AEs and serious AEs occurred at a rate of 396 events/100 patient-years and 15 events/100 patient-years, respectively.
CONCLUSIONS
Long-term treatment with adalimumab led to quiescence and reduced corticosteroid use for patients who entered VISUAL III with active uveitis and maintenance of quiescence for those with inactive uveitis. AEs were comparable to those reported in the parent trials and consistent with the known safety profile of adalimumab.",2020,"CONCLUSIONS
Long-term treatment with adalimumab led to quiescence and reduced corticosteroid use for patients who entered VISUAL III with active uveitis and maintenance of quiescence for those with inactive uveitis.","['Patients With Noninfectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis', 'patients with noninfectious intermediate, posterior, or panuveitis', 'Adults who had completed a randomized', 'patients who entered VISUAL III with active uveitis and maintenance of quiescence for those with inactive uveitis', '424 patients enrolled, 67% (283/424) had active uveitis and 33% (141/424) had inactive uveitis at study entry; 60 patients subsequently met exclusion criteria, and 364 patients were included in the intent-to-treat analysis']","['adalimumab', 'Adalimumab', 'placebo-controlled phase 3 parent trial (VISUAL I or II) without treatment failure (inactive uveitis) or discontinued after meeting treatment failure criteria (active uveitis', 'subcutaneous adalimumab']","['percentage of patients in quiescence', 'Adverse events (AEs', 'long-term safety and quiescence; other efficacy variables included inflammatory lesions, anterior chamber cell and vitreous haze grade, macular edema, visual acuity, and dose of uveitis-related corticosteroids', 'Mean daily dose of corticosteroids', 'Corticosteroid-free quiescence', 'serious AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042166', 'cui_str': 'Intermediate uveitis'}, {'cui': 'C0042167', 'cui_str': 'Posterior uveitis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C0423282', 'cui_str': 'Anterior chamber cells'}, {'cui': 'C4073113', 'cui_str': 'Vitreous haze'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",424.0,0.321011,"CONCLUSIONS
Long-term treatment with adalimumab led to quiescence and reduced corticosteroid use for patients who entered VISUAL III with active uveitis and maintenance of quiescence for those with inactive uveitis.","[{'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Suhler', 'Affiliation': 'Oregon Health & Science University, Casey Eye Institute, OHSU-PSU School of Public Health, and VA Portland Health Care System, Portland, OR, USA. Electronic address: suhlere@ohsu.edu.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Duke University, Durham, NC, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Fortin', 'Affiliation': 'University of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Lyndell L', 'Initials': 'LL', 'LastName': 'Lim', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, VIC, Australia.'}, {'ForeName': 'Pauline T', 'Initials': 'PT', 'LastName': 'Merrill', 'Affiliation': 'Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Dick', 'Affiliation': 'University of Bristol, Bristol Eye Hospital, Bristol, UK, and National Institute for Health Research (NIHR) Biomedical Research Centre at Moorfields Eye Hospital and University College London, Institute of Ophthalmology, London, UK.'}, {'ForeName': 'Antoine P', 'Initials': 'AP', 'LastName': 'Brezin', 'Affiliation': 'Université Paris Descartes, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Quan Dong', 'Initials': 'QD', 'LastName': 'Nguyen', 'Affiliation': 'Byers Eye Institute, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Thorne', 'Affiliation': 'Department of Ophthalmology, Wilmer Eye Institute, Johns Hopkins University School of Medicine, and Department of Epidemiology, Center for Clinical Trials, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Van Calster', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cimino', 'Affiliation': 'Ocular Immunology Unit, Azienda USL IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Adan', 'Affiliation': 'Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Goto', 'Affiliation': 'Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Toshikatsu', 'Initials': 'T', 'LastName': 'Kaburaki', 'Affiliation': 'University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kramer', 'Affiliation': 'Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Albert T', 'Initials': 'AT', 'LastName': 'Vitale', 'Affiliation': 'John A. Moran Eye Center, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kron', 'Affiliation': 'AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany.'}, {'ForeName': 'Alexandra P', 'Initials': 'AP', 'LastName': 'Song', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Pathai', 'Affiliation': 'Johnson & Johnson Vision, Singapore.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Douglas', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Schlaen', 'Affiliation': 'Austral University, Buenos Aires, Argentina.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Muccioli', 'Affiliation': 'Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Mirjam E J', 'Initials': 'MEJ', 'LastName': 'Van Velthoven', 'Affiliation': 'Rotterdam Eye Hospital, Rotterdam, Netherlands.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Zierhut', 'Affiliation': 'University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Rosenbaum', 'Affiliation': 'Departments of Ophthalmology and Medicine, Oregon Health & Science University and Legacy Devers Eye Institute, Portland, OR, USA.'}]",Ophthalmology,['10.1016/j.ophtha.2020.10.036']
2321,33157152,Intranasal oxytocin attenuates insula activity in response to dynamic angry faces.,"The effects of intranasal oxytocin on amygdala activity during emotional perception are often mixed. Given that the brain is organized into networks of interconnected areas, functional connectivity might provide an effective way to further understand the oxytocin effect. The aim of the present study was to investigate whether oxytocin administration affects amygdala activity and its functional connectivity during dynamic facial expression perception. Using a between-group, double-blind, placebo-controlled design, 55 participants were randomly assigned to groups receiving a single dose of 24 IU oxytocin or a placebo via intranasal administration. An implicit emotional task was employed to investigate the effect of oxytocin on neural responses to dynamic angry, neutral, and happy facial expressions with fMRI. Participants were instructed to respond only when the inverted dynamic faces were presented. The results indicated that oxytocin attenuated activation of insula and emotional processing-related regions (e.g., ACC, thalamus, and MFG) during the viewing of dynamic angry faces. However, functional connectivity between the regions involved in the perception of dynamic angry faces was not changed following oxytocin administration. The present findings may contribute to our understanding of the anxiolytic effects of oxytocin and eventually facilitate human clinical applications.",2020,"The results indicated that oxytocin attenuated activation of insula and emotional processing-related regions (e.g., ACC, thalamus, and MFG) during the viewing of dynamic angry faces.",['55 participants'],"['placebo', 'intranasal oxytocin', 'oxytocin', 'Intranasal oxytocin']","['neural responses to dynamic angry, neutral, and happy facial expressions with fMRI', 'activation of insula and emotional processing-related regions (e.g., ACC, thalamus, and MFG', 'amygdala activity']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",55.0,0.160768,"The results indicated that oxytocin attenuated activation of insula and emotional processing-related regions (e.g., ACC, thalamus, and MFG) during the viewing of dynamic angry faces.","[{'ForeName': 'Yuanxiao', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, 400715, China; School of Psychology, Nanjing Normal University, Nanjing, 210024, China.'}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Ran', 'Affiliation': 'Institute of Education, China West Normal University, Nanchong, 637002, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Na', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, 200062, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, 400715, China.'}, {'ForeName': 'Wenshuang', 'Initials': 'W', 'LastName': 'Long', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, 400715, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, 400715, China. Electronic address: chenxu@swu.edu.cn.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107976']
2322,33157233,"Rice flour fermented with Lactobacillus paracasei CBA L74 in the treatment of atopic dermatitis in infants: A randomized, double- blind, placebo- controlled trial.","To assess the effect of a fermented rice-flour obtained from Lactobacillus paracasei CBA L74 in managing infants with moderate to severe atopic dermatitis. Infants with moderate to severe atopic dermatitis, aged 6-36 months, were randomly assigned to receive once-daily consumption of rice flour containing heat-killed probiotic Lactobacillus paracasei CBA L74 or placebo for 12 weeks as supplementary approach to topical treatment. Primary outcome was SCORAD index change from baseline to 12 weeks; secondary outcomes were gut microbiota composition, as evaluated by the analysis of fecal samples, and serum cytokines at baseline and at the end of the intervention period in both groups, and steroid usage over the treatment period and one month after stopping it. V3-V4 region of the 16S ribosomal RNA gene was sequenced to evaluate changes in the gut microbiota. SCORAD index decreased over the treatment period in both groups. The difference in the SCORAD change was -2.1 (-5.5 to 1.3; p = 0.223) for the experimental vs. the placebo group, not reaching the minimal clinical difference of 8.7 units. The use of topical steroids, measured as finger tips units, decreased from 4 to 16 weeks, in both groups; the reduction was significantly higher in experimental than in placebo group (p value from Wilcoxon rank sum test = 0.031). No significant differences were observed for cytokines levels between groups. The composition of gut microbiota at the phylum and class taxonomic levels resulted very similar, at baseline and after intervention, in both groups. Similarly, no significant differences were observed in the relative abundance of bacterial genera between groups. In conclusion, though the heat-killed Lactobacillus paracaseiwas not proved to be effective in reducing the severity of atopic dermatitis, it showed a steroid sparing effect the value of which needs to be further investigated.",2020,"The composition of gut microbiota at the phylum and class taxonomic levels resulted very similar, at baseline and after intervention, in both groups.","['atopic dermatitis in infants', 'infants with moderate to severe atopic dermatitis', 'Infants with moderate to severe atopic dermatitis, aged 6-36 months']","['fermented rice-flour obtained from Lactobacillus paracasei CBA L74', 'placebo', 'Rice flour fermented with Lactobacillus paracasei CBA L74', 'rice flour containing heat-killed probiotic Lactobacillus paracasei CBA L74 or placebo']","['SCORAD index', 'severity of atopic dermatitis', 'SCORAD index change from baseline to 12 weeks; secondary outcomes were gut microbiota composition, as evaluated by the analysis of fecal samples, and serum cytokines', 'relative abundance of bacterial genera', 'SCORAD change', 'cytokines levels']","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}, {'cui': 'C0025922', 'cui_str': 'Mouse, Inbred CBA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162388', 'cui_str': 'Killing'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.112248,"The composition of gut microbiota at the phylum and class taxonomic levels resulted very similar, at baseline and after intervention, in both groups.","[{'ForeName': 'Enza', 'Initials': 'E', 'LastName': ""D'Auria"", 'Affiliation': ""Department of Paediatrics, Vittore Buzzi Children's Hospital, University of Milan, Milan, Italy. Electronic address: enza.dauria@unimi.it.""}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Panelli', 'Affiliation': 'Pediatric Clinical Research Center ""Invernizzi"", University of Milan, Milan, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Lunardon', 'Affiliation': ""Department of Paediatrics, Vittore Buzzi Children's Hospital, University of Milan, Milan, Italy.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Pajoro', 'Affiliation': 'Pediatric Clinical Research Center ""Invernizzi"", University of Milan, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Paradiso', 'Affiliation': ""Department of Paediatrics, Vittore Buzzi Children's Hospital, University of Milan, Milan, Italy.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Beretta', 'Affiliation': ""Department of Paediatrics, Vittore Buzzi Children's Hospital, University of Milan, Milan, Italy.""}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Loretelli', 'Affiliation': 'Pediatric Clinical Research Center ""Invernizzi"", University of Milan, Milan, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Tosi', 'Affiliation': ""Department of Paediatrics, Vittore Buzzi Children's Hospital, University of Milan, Milan, Italy.""}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Perini', 'Affiliation': 'Pediatric Clinical Research Center ""Invernizzi"", University of Milan, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Bedogni', 'Affiliation': 'Clinical Epidemiology Unit, Liver Research Center, Basovizza, Trieste, Italy.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Abdelsalam', 'Affiliation': 'Pediatric Clinical Research Center Fondazione Romeo e Enrica Invernizzi, Department of Biomedical and Clinical Science L. Sacco, University of Milan, Milan.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fiorina', 'Affiliation': ""Pediatric Clinical Research Center Fondazione Romeo e Enrica Invernizzi, Department of Biomedical and Clinical Science L. Sacco, University of Milan, Milan; Nephrology Division, Boston Children's Hospital, Harvard Medical School, Enders Building 5th Floor Room EN511, 300 Longwood Ave, Boston, MA, USA.""}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Bandi', 'Affiliation': 'Pediatric Clinical Research Center Fondazione Romeo e Enrica Invernizzi, Department of Biomedical and Clinical Science L. Sacco, University of Milan, Milan.'}, {'ForeName': 'Gian Vincenzo', 'Initials': 'GV', 'LastName': 'Zuccotti', 'Affiliation': ""Department of Paediatrics, Vittore Buzzi Children's Hospital, University of Milan, Milan, Italy.""}]",Pharmacological research,['10.1016/j.phrs.2020.105284']
2323,31856636,Evaluation of the Short-Term Cost-Effectiveness of IDegLira Versus Basal Insulin and Basal-Bolus Therapy in Patients with Type 2 Diabetes Based on Attainment of Clinically Relevant Treatment Targets.,"BACKGROUND
Effective glycemic control can reduce the risk of complications and their related costs in patients with type 2 diabetes (T2D). Many patients fail to reach hemoglobin A1c (HbA1c) ≤ 6.5% or < 7.0%, often due to adverse effects of treatment, such as hypoglycemia and weight gain. Glycemic targets should be individualized and consider multiple factors, including the risk of adverse events and the patient's characteristics and comorbid conditions.
OBJECTIVE
To compare the odds and annual cost of achieving treatment targets, which incorporate HbA1c targets of < 7.5%, < 8.0%, and ≤ 9.0%, with insulin degludec/liraglutide (IDegLira) versus basal insulin and basal-bolus therapy.
METHODS
This is a post hoc analysis of the DUAL V and DUAL VII 26-week trials, which randomized patients with T2D uncontrolled (HbA1c 7%-10%) on insulin glargine 100 units/mL (IGlar U100) and metformin to IDegLira or continued IGlar U100 titration (DUAL V) or IGlar U100 + insulin aspart (DUAL VII), all with metformin. Proportions of patients achieving HbA1c targets (< 7.5%, < 8.0%, and ≤ 9.0%) by the end of trial were assessed via 3 outcomes: alone, without either hypoglycemia or weight gain (double composite outcome), or without a combination of hypoglycemia and weight gain (triple composite outcome). The cost per patient achieving the triple composite outcome at each HbA1c target (< 7.5%, < 8.0%, and ≤ 9.0%) was calculated by dividing the annual cost of treatment by the proportion of patients achieving the target. This short-term (1-year) cost-effectiveness analysis was conducted from the perspective of a U.S. health care payer.
RESULTS
More patients achieved HbA1c < 7.5% ( P < 0.0001) and < 8.0% ( P = 0.0003), and a similar percentage achieved HbA1c ≤ 9.0% with IDegLira versus IGlar U100 (DUAL V). Similar proportions of patients achieved all 3 HbA1c targets with IDegLira compared with basal-bolus therapy (DUAL VII). The odds of achieving double or triple composite outcomes were significantly higher for IDegLira versus IGlar U100 or basal-bolus for all 3 HbA1c targets ( P < 0.0001 in each case) in both trials. For each $1 spent on IDegLira, the equivalent annual costs per patient to achieve HbA1c targets of < 7.5%, < 8.0%, or ≤ 9.0% without hypoglycemia and without weight gain were $2.43, $2.10, and $2.05, respectively, for IGlar U100 and $6.33, $5.80, and $6.06, respectively, for basal-bolus therapy.
CONCLUSIONS
Based on data from DUAL V and DUAL VII, this analysis showed that a greater or similar proportion of patients with T2D reached HbA1c targets with IDegLira compared with IGlar U100/basal-bolus therapy. Odds of achieving double or triple composite outcomes of HbA1c reduction without hypoglycemia and/or without weight gain were greatest for IDegLira. Short-term cost analyses based on the triple composite outcomes suggest that IDegLira is a cost-effective treatment option in the United States compared with either uptitration of IGlar U100 or basal-bolus therapy.
DISCLOSURES
This study was supported by Novo Nordisk A/S. The analysis was based on the DUAL V (NCT01952145) and DUAL VII (NCT02420262) trials, which were funded and conducted by Novo Nordisk. This post hoc analysis was conceived and interpreted by the authors and drafted with medical writing support that was funded by Novo Nordisk. Novo Nordisk also reviewed the manuscript for medical accuracy. Hunt and Malkin are employees of Ossian Health Economics and Communications, which received consulting fees from Novo Nordisk during the conduct of this study and has received consulting fees from Novo Nordisk, unrelated to this study. Mocarski, Ranthe, and Schiffman are employees of Novo Nordisk and Novo Nordisk A/S. Cannon has received speaker fees/honoraria from Abbvie, Amgen, and Janssen; speaker fees from Novo Nordisk; and has stock ownership in Novo Nordisk. Bargiota has received speaker fees/honoraria from AstraZeneca, Eli Lilly, MSD, Novo Nordisk, Sanofi, Boehringer Ingelheim, and Novartis. Billings has received personal fees from Novo Nordisk, Sanofi, and Dexcom, unrelated to this study. Leiter reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk, Sanofi, Servier, and GSK, unrelated to this study. Doshi has no relevant conflicts of interest to disclose. Parts of this study were presented as a poster at the AMCP Managed Care & Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.",2020,"Short-term cost analyses based on the triple composite outcomes suggest that IDegLira is a cost-effective treatment option in the United States compared with either uptitration of IGlar U100 or basal-bolus therapy.
","['patients with T2D uncontrolled (HbA1c 7%-10%) on', 'patients with type 2 diabetes (T2D', 'Patients with Type 2 Diabetes Based on Attainment of Clinically Relevant Treatment Targets']","['IDegLira', 'IDegLira Versus Basal Insulin and Basal-Bolus Therapy', 'insulin glargine 100 units/mL (IGlar U100) and metformin to IDegLira or continued IGlar U100 titration (DUAL V) or IGlar U100 + insulin aspart (DUAL VII), all with metformin']","['hypoglycemia or weight gain (double composite outcome), or without a combination of hypoglycemia and weight gain (triple composite outcome', 'weight gain', 'odds of achieving double or triple composite outcomes', 'hypoglycemia', 'hypoglycemia and weight gain', 'hypoglycemia and without weight gain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4059165', 'cui_str': 'insulin degludec and liraglutide'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0445385', 'cui_str': 'VII'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205174', 'cui_str': 'Triple'}]",,0.069773,"Short-term cost analyses based on the triple composite outcomes suggest that IDegLira is a cost-effective treatment option in the United States compared with either uptitration of IGlar U100 or basal-bolus therapy.
","[{'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Cannon', 'Affiliation': 'Endocrinology, Jefferson Health NJ, Voorhees, New Jersey.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Bargiota', 'Affiliation': 'Department of Endocrinology and Metabolic Diseases, University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Billings', 'Affiliation': 'NorthShore University HealthSystem, Skokie, Illinois, and University of Chicago Pritzker School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Barnaby', 'Initials': 'B', 'LastName': 'Hunt', 'Affiliation': 'Ossian Health Economics and Communications, Basel, Switzerland.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Ontario.""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Malkin', 'Affiliation': 'Ossian Health Economics and Communications, Basel, Switzerland.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Mocarski', 'Affiliation': 'Novo Nordisk, Plainsboro, New Jersey.'}, {'ForeName': 'Mattis Flyvholm', 'Initials': 'MF', 'LastName': 'Ranthe', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Schiffman', 'Affiliation': 'Novo Nordisk, Plainsboro, New Jersey.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Doshi', 'Affiliation': 'PrimeCare Medical Group, Houston, Texas.'}]",Journal of managed care & specialty pharmacy,['10.18553/jmcp.2019.19035']
2324,31875000,Collagen fragments quantified in serum as measures of desmoplasia associate with survival outcome in patients with advanced pancreatic cancer.,"Pancreatic ductal adenocarcinoma (PDAC) patients have poor prognosis and poor response to treatment. This is largely due to PDAC being associated with a dense and active stroma and tumor fibrosis (desmoplasia). Desmoplasia is characterized by excessive degradation and formation of the extracellular matrix (ECM) generating collagen fragments that are released into circulation. We evaluated the association of specific collagen fragments measured in pre-treatment serum with outcome in patients with PDAC. Matrix metalloprotease (MMP)-degraded type I collagen (C1M), type III collagen (C3M), type IV collagen (C4M) and a pro-peptide of type III collagen (PRO-C3) were measured by ELISA in pre-treatment serum from a randomized phase 3 clinical trial of patients with stage III/IV PDAC treated with 5-fluorouracil based therapy (n = 176). The collagen fragments were evaluated for their correlation (r, Spearman) with serum CA19-9 and for their association with overall survival (OS) based on Cox-regression analyses. In this phase 3 PDAC trial, pre-treatment serum collagen fragment levels were above the reference range for 67%-98% of patients, with median values in PDAC approximately two-fold higher than reference levels. Collagen fragment levels did not correlate with CA19-9 (r = 0.049-0.141, p = ns). On a continuous basis, higher levels of all collagen fragments were associated with significantly shorter OS. When evaluating degradation (C3M) and formation (PRO-C3) of type III collagen further, higher PRO-C3 was associated with poor OS (>25 th percentile cut-point, HR = 2.01, 95%CI = 1.33-3.05) and higher C3M/PRO-C3 ratio was associated with improved OS (>25 th percentile cut-point, HR = 0.53, 95%CI = 0.34-0.80). When adjusting for CA19-9 and clinical covariates, PRO-C3 remained significant (HR = 1.65, 95%CI = 1.09-2.48). In conclusion, collagen remodeling quantified in pre-treatment serum as a surrogate measure of desmoplasia was significantly associated with OS in a phase 3 clinical PDAC trial, supporting the link between desmoplasia, tumorigenesis, and response to treatment. If validated, these biomarkers may have prognostic and/or predictive potential in future PDAC trials.",2019,"Collagen fragment levels did not correlate with CA19-9 (r = 0.049-0.141, p = ns).","['patients with advanced pancreatic cancer', 'Pancreatic ductal adenocarcinoma (PDAC) patients', 'patients with stage III/IV PDAC treated with', 'patients with PDAC']","['Matrix metalloprotease (MMP)-degraded type I collagen (C1M), type III collagen (C3M), type IV collagen (C4M) and a pro-peptide of type III collagen (PRO-C3', '5-fluorouracil based therapy']","['serum collagen fragment levels', 'Collagen fragment levels', 'degradation (C3M) and formation (PRO-C3) of type III collagen further, higher PRO-C3', 'C3M/PRO-C3 ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0009332', 'cui_str': 'Collagen type III'}, {'cui': 'C0009333', 'cui_str': 'Collagen type IV'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0071997', 'cui_str': 'Pro-Complement 3'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0071997', 'cui_str': 'Pro-Complement 3'}, {'cui': 'C0009332', 'cui_str': 'Collagen type III'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0254088,"Collagen fragment levels did not correlate with CA19-9 (r = 0.049-0.141, p = ns).","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Willumsen', 'Affiliation': 'Biomarkers & Research, Nordic Bioscience, Herlev, Denmark. nwi@nordicbio.com.'}, {'ForeName': 'Suhail M', 'Initials': 'SM', 'LastName': 'Ali', 'Affiliation': 'Division of Hematology/Oncology, Penn State Health Milton S Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Leitzel', 'Affiliation': 'Division of Hematology/Oncology, Penn State Health Milton S Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Drabick', 'Affiliation': 'Division of Hematology/Oncology, Penn State Health Milton S Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Yee', 'Affiliation': 'Division of Hematology/Oncology, Penn State Health Milton S Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Hyma V', 'Initials': 'HV', 'LastName': 'Polimera', 'Affiliation': 'Division of Hematology/Oncology, Penn State Health Milton S Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Nagabhairu', 'Affiliation': 'Pinnacle Health System, University of Pittsburgh Medical Center, Harrisburg, PA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Krecko', 'Affiliation': 'Division of Hematology/Oncology, Penn State Health Milton S Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Division of Hematology/Oncology, Penn State Health Milton S Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Maddukuri', 'Affiliation': 'Division of Hematology/Oncology, Penn State Health Milton S Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Moku', 'Affiliation': 'Division of Hematology/Oncology, Penn State Health Milton S Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Aamnah', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Division of Hematology/Oncology, Penn State Health Milton S Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Joyson', 'Initials': 'J', 'LastName': 'Poulose', 'Affiliation': 'Division of Hematology/Oncology, Penn State Health Milton S Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Menon', 'Affiliation': 'Division of Hematology/Oncology, Penn State Health Milton S Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pancholy', 'Affiliation': 'Division of Hematology/Oncology, Penn State Health Milton S Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Costa', 'Affiliation': 'Oncology division, Hospital de Santa Maria, Lisboa, Portugal.'}, {'ForeName': 'Morten A', 'Initials': 'MA', 'LastName': 'Karsdal', 'Affiliation': 'Biomarkers & Research, Nordic Bioscience, Herlev, Denmark.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Lipton', 'Affiliation': 'Division of Hematology/Oncology, Penn State Health Milton S Hershey Medical Center, Hershey, PA, USA.'}]",Scientific reports,['10.1038/s41598-019-56268-3']
2325,31875053,Predictive Modelling of Lung Function using Emphysematous Density Distribution.,"Target lung tissue selection remains a challenging task to perform for treating severe emphysema with lung volume reduction (LVR). In order to target the treatment candidate, the percentage of low attenuation volume (LAV%) representing the proportion of emphysema volume to whole lung volume is measured using computed tomography (CT) images. Although LAV% have shown to have a correlation with lung function in patients with chronic obstructive pulmonary disease (COPD), similar measurements of LAV% in whole lung or lobes may have large variations in lung function due to emphysema heterogeneity. The functional information of regional emphysema destruction is required for supporting the choice of optimal target. The purpose of this study is to develop an emphysema heterogeneity descriptor for the three-dimensional emphysematous bullae according to the size variations of emphysematous density (ED) and their spatial distribution. The second purpose is to derive a predictive model of airflow limitation based on the regional emphysema heterogeneity. Deriving the bullous representation and grouping them into four scales in the upper and lower lobes, a predictive model is computed using the linear model fitting to estimate the severity of lung function. A total of 99 subjects, 87 patients with mild to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage I~IV) and 12 control participants with normal lung functions (forced expiratory volume in one second (FEV 1 )/forced vital capacity (FVC) > 0.7) were evaluated. The final model was trained with stratified cross-validation on randomly selected 75% of the dataset (n = 76) and tested on the remaining dataset (n = 23). The dispersed cases of LAV% inconsistent with their lung function outcome were evaluated, and the correlation study suggests that comparing to LAV of larger bullae, the widely spread smaller bullae with equivalent LAV has a larger impact on lung function. The testing dataset has the correlation of r = -0.76 (p < 0.01) between the whole lung LAV% and FEV 1 /FVC, whereas using two ED % of scales and location-dependent variables to predict the emphysema-associated FEV 1 /FVC, the results shows their correlation of 0.82 (p < 0.001) with clinical FEV 1 /FVC.",2019,stage I~IV) and 12 control participants with normal lung functions (forced expiratory volume in one second (FEV 1 )/forced vital capacity (FVC) ,"['99 subjects, 87 patients with mild to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD', 'patients with chronic obstructive pulmonary disease (COPD']",[],['normal lung functions (forced expiratory volume in one second (FEV 1 )/forced vital capacity (FVC'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0018026', 'cui_str': 'Gold'}]",[],"[{'cui': 'C0438186', 'cui_str': 'Lung function testing normal'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",99.0,0.0122668,stage I~IV) and 12 control participants with normal lung functions (forced expiratory volume in one second (FEV 1 )/forced vital capacity (FVC) ,"[{'ForeName': 'Kuo-Lung', 'Initials': 'KL', 'LastName': 'Lor', 'Affiliation': 'Department of Biomedical Engineering, National Taiwan University, No. 1, Sec. 1, Jen - Ai Rd., Taipei City, 100, Taiwan (R.O.C.).'}, {'ForeName': 'Cheng-Pei', 'Initials': 'CP', 'LastName': 'Liu', 'Affiliation': 'Department of Biomedical Engineering, National Taiwan University, No. 1, Sec. 1, Jen - Ai Rd., Taipei City, 100, Taiwan (R.O.C.).'}, {'ForeName': 'Yeun-Chung', 'Initials': 'YC', 'LastName': 'Chang', 'Affiliation': 'National Taiwan University Hospital, No. 7, Chung Shan S. Rd., Zhongzheng Dist., Taipei City, 10002, Taiwan (R.O.C.).'}, {'ForeName': 'Chong-Jen', 'Initials': 'CJ', 'LastName': 'Yu', 'Affiliation': 'National Taiwan University Hospital, No. 7, Chung Shan S. Rd., Zhongzheng Dist., Taipei City, 10002, Taiwan (R.O.C.).'}, {'ForeName': 'Cheng-Yi', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Cardinal Tien Hospital, No. 362, Zhongzheng Rd., Xindian Dist., New Taipei City, 23148, Taiwan (R.O.C.).'}, {'ForeName': 'Ming-Jui', 'Initials': 'MJ', 'LastName': 'Chung', 'Affiliation': 'Department of Biomedical Engineering, National Taiwan University, No. 1, Sec. 1, Jen - Ai Rd., Taipei City, 100, Taiwan (R.O.C.).'}, {'ForeName': 'Fan-Ya', 'Initials': 'FY', 'LastName': 'Lin', 'Affiliation': 'Department of Biomedical Engineering, National Taiwan University, No. 1, Sec. 1, Jen - Ai Rd., Taipei City, 100, Taiwan (R.O.C.).'}, {'ForeName': 'Chung-Ming', 'Initials': 'CM', 'LastName': 'Chen', 'Affiliation': 'Department of Biomedical Engineering, National Taiwan University, No. 1, Sec. 1, Jen - Ai Rd., Taipei City, 100, Taiwan (R.O.C.). chung@ntu.edu.tw.'}]",Scientific reports,['10.1038/s41598-019-56351-9']
2326,32188442,Genetic diversity of Plasmodium falciparum and genetic profile in children affected by uncomplicated malaria in Cameroon.,"BACKGROUND
Malaria is a major public health problem in Cameroon. The study of the genetic diversity within parasite population is essential for understanding the mechanism underlying malaria pathology and to determine parasite clones profile in an infection, for proper malaria control strategies. The objective of this study was to perform a molecular characterization of highly polymorphic genetic markers of Plasmodium falciparum, and to determine allelic distribution with their influencing factors valuable to investigate malaria transmission dynamics in Cameroon.
METHODS
A total of 350 P. falciparum clinical isolates were characterized by genotyping block 2 of msp-1, block 3 of msp-2, and region II of glurp gene using nested PCR and DNA sequencing between 2012 and 2013.
RESULTS
A total of 5 different genotypes with fragment sizes ranging from 597 to 817 bp were recorded for GLURP. Overall, 16 MSP-1 genotypes, including K1, MAD20 and RO33 were identified, ranging from 153 to 335 bp. A peculiarity about this study is the RO33 monomorphic pattern revealed among the Pfmsp-1 allelic type. Again, this study identified 27 different Pfmsp-2 genotypes, ranging from 140 to 568 bp in size, including 15 belonging to the 3D7-type and 12 to the FC27 allelic families. The analysis of the MSP-1 and MSP-2 peptides indicates that the region of the alignment corresponding K1 polymorphism had the highest similarity in the MSP1and MSP2 clade followed by MAD20 with 93% to 100% homology. Therefore, population structure of P. falciparum isolates is identical to that of other areas in Africa, suggesting that vaccine developed with K1 and MAD20 of Pfmsp1 allelic variant could be protective for Africa children but these findings requires further genetic and immunological investigations. The multiplicity of infection (MOI) was significantly higher (P < 0.05) for Pfmsp-2 loci (3.82), as compare with Pfmsp-1 (2.51) and heterozygotes ranged from 0.55 for Pfmsp-1 to 0.96 for Pfmsp-2.
CONCLUSION
High genetic diversity and allelic frequencies in P. falciparum isolates indicate a persisting high level of transmission. This study advocate for an intensification of the malaria control strategies in Cameroon. Trial registration This study was approved by Cameroon National Ethics Committee. It is a randomized controlled trial retrospectively registered in NIH U.S. National Library of Medicine, ClinicalTrials.gov on the 28/11/2016 at https://clinicaltrials.gov/ct2/show/NCT02974348 with the registration number NCT02974348.",2020,"The multiplicity of infection (MOI) was significantly higher (P < 0.05) for Pfmsp-2 loci (3.82), as compare with Pfmsp-1 (2.51) and heterozygotes ranged from 0.55 for Pfmsp-1 to 0.96 for Pfmsp-2.
CONCLUSION
High genetic diversity and allelic frequencies in P. falciparum isolates indicate a persisting high level of transmission.","['27 different Pfmsp-2 genotypes, ranging from 140 to 568\xa0bp in size, including 15 belonging to the 3D7-type and 12 to the FC27 allelic families', 'A total of 5 different genotypes with fragment sizes ranging from 597 to 817\xa0bp were recorded for GLURP', 'Cameroon', 'children affected by uncomplicated malaria in Cameroon']",[],"['K1, MAD20 and RO33', 'multiplicity of infection (MOI']","[{'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]",[],"[{'cui': 'C0449822', 'cui_str': 'Multiplicity'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.123173,"The multiplicity of infection (MOI) was significantly higher (P < 0.05) for Pfmsp-2 loci (3.82), as compare with Pfmsp-1 (2.51) and heterozygotes ranged from 0.55 for Pfmsp-1 to 0.96 for Pfmsp-2.
CONCLUSION
High genetic diversity and allelic frequencies in P. falciparum isolates indicate a persisting high level of transmission.","[{'ForeName': 'Theresia Njuabe', 'Initials': 'TN', 'LastName': 'Metoh', 'Affiliation': 'Department of Biochemistry, Faculty of Science, The University of Bamenda, P. O. Box 39 Bambili, Bamenda, Cameroon. njuabe@yahoo.fr.'}, {'ForeName': 'Jun-Hu', 'Initials': 'JH', 'LastName': 'Chen', 'Affiliation': ""National Institute of Parasitic Diseases, Chinese Centre for Disease Control and Prevention, Shanghai, 200025, People's Republic of China.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Fon-Gah', 'Affiliation': 'ITC Enschede, University of Twenty, Hengelosestraat 99, 7514 AE, Enschede, The Netherlands.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ""National Institute of Parasitic Diseases, Chinese Centre for Disease Control and Prevention, Shanghai, 200025, People's Republic of China.""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Moyou-Somo', 'Affiliation': 'Institute of Medical Research and Medicinal Plants-IMPM, P. O. 6123, Yaoundé, Cameroon.'}, {'ForeName': 'Xiao-Nong', 'Initials': 'XN', 'LastName': 'Zhou', 'Affiliation': ""National Institute of Parasitic Diseases, Chinese Centre for Disease Control and Prevention, Shanghai, 200025, People's Republic of China.""}]",Malaria journal,['10.1186/s12936-020-03161-4']
2327,33157268,FibroMeter scores for the assessment of liver fibrosis in patients with autoimmune liver diseases.,"INTRODUCTION AND OBJECTIVES
We assessed FibroMeter virus (FMvirus) and FibroMeter vibration-controlled transient elastography (FMVCTE) in 134 patients with autoimmune liver diseases [ALD, autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC)], in order to assess new potential non-invasive biomarkers of liver fibrosis in patients with ALD, as similar data are missing.
PATIENTS AND METHODS
The following groups were included: group 1: n = 78 AIH; group 2: n = 56 PBC. FMvirus and FMVCTE were determined in all 134 patients who underwent liver biopsy and TE the same day with sera collection. In addition, APRI and FIB-4 scores were calculated.
RESULTS
The AUCs for TE and FMVCTE were significantly better (0.809; p < 0.001 and 0.772; p = 0.001, respectively for AIH and 0.997; p < 0.001 and 1; p < 0.001, for PBC) than the other three markers in predicting ≥ F3 fibrosis irrespective of the biochemical activity. FMVCTE and TE had good diagnostic accuracy (75.6% and 73%, respectively) for predicting severe fibrosis in AIH and performed even better in PBC (94.6% and 96.4%, respectively). The cut-offs of TE and FMVCTE had the best sensitivity and specificity in predicting ≥ F3 fibrosis in both AIH and PBC.
CONCLUSIONS
FMVCTE seems to detect severe fibrosis equally to TE in patients with ALD but with better specificity. Biochemical disease activity did not seem to affect their diagnostic accuracy in ALD and therefore, could be helpful for the assessment of fibrosis, especially if they are performed sequentially (first TE with the best sensitivity and then FMVCTE with the best specificity).",2020,"The cut-offs of TE and FMVCTE had the best sensitivity and specificity in predicting ≥ F3 fibrosis in both AIH and PBC.
","['134 patients with autoimmune liver diseases [ALD, autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC', 'patients with autoimmune liver diseases', 'patients with ALD', '134 patients who underwent liver biopsy and TE the same day with sera collection']",['FibroMeter virus (FMvirus) and FibroMeter vibration-controlled transient elastography (FMVCTE'],"['good diagnostic accuracy', 'APRI and FIB-4 scores', 'FibroMeter scores']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400936', 'cui_str': 'Autoimmune liver disease'}, {'cui': 'C0162309', 'cui_str': 'Adrenoleukodystrophy'}, {'cui': 'C0241910', 'cui_str': 'Chronic autoimmune hepatitis'}, {'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0600644', 'cui_str': 'Collection'}]","[{'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C3854624', 'cui_str': 'Vibration controlled transient elastography'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",134.0,0.0241128,"The cut-offs of TE and FMVCTE had the best sensitivity and specificity in predicting ≥ F3 fibrosis in both AIH and PBC.
","[{'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Zachou', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Lygoura', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Pinelopi', 'Initials': 'P', 'LastName': 'Arvaniti', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Giannoulis', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Nikolaos K', 'Initials': 'NK', 'LastName': 'Gatselis', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Koukoulis', 'Affiliation': 'Department of Pathology, Medical School, University of Thessaly, Larissa, Greece.'}, {'ForeName': 'George N', 'Initials': 'GN', 'LastName': 'Dalekos', 'Affiliation': 'Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece. Electronic address: georgedalekos@gmail.com.'}]",Annals of hepatology,['10.1016/j.aohep.2020.10.013']
2328,33157308,"Esophageal balloon calibration during Sigh: A physiologic, randomized, cross-over study.","PURPOSE
Optimal esophageal balloon filling volume (V best ) depends on the intrathoracic pressure. During Sigh breath delivered by the ventilator machine, esophageal balloon is surrounded by elevated intrathoracic pressure that might require higher filling volume for accurate measure of tidal changes in esophageal pressure (Pes). The primary aim of our investigation was to evaluate and compare V best during volume controlled and pressure support breaths vs. Sigh breath.
MATERIALS AND METHODS
Twenty adult patients requiring invasive volume-controlled ventilation (VCV) for hypoxemic acute respiratory failure were enrolled. After the insertion of a naso-gastric catheter equipped with 10 ml esophageal balloon, each patient underwent three 30-min trials as follows: VCV, pressure support ventilation (PSV), and PSV + Sigh. Sigh was added to PSV as 35 cmH 2 O pressure-controlled breath over 4 s, once per minute. PSV and PSV + Sigh were randomly applied and, at the end of each step, esophageal balloon calibration was performed.
RESULTS
V best was higher for Sigh breath (4.5 [3.0-6.8] ml) compared to VCV (1.5 [1.0-2.9] ml, P = 0.0004) and PSV tidal breath (1.0 [0.5-2.4] ml, P < 0.0001).
CONCLUSIONS
During Sigh breath, applying a calibrated approach for Pes assessment, a higher V best was required compared to VCV and PSV tidal breath.",2020,"RESULTS
V best was higher for Sigh breath (4.5 [3.0-6.8] ml) compared to VCV","['hypoxemic acute respiratory failure were enrolled', 'Twenty adult patients requiring']","['VCV, pressure support ventilation (PSV), and PSV\xa0+\xa0Sigh', 'VCV', 'invasive volume-controlled ventilation (VCV']","['PSV tidal breath', 'Sigh breath']","[{'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0425481', 'cui_str': 'Sighing respiration'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0425481', 'cui_str': 'Sighing respiration'}]",20.0,0.099474,"RESULTS
V best was higher for Sigh breath (4.5 [3.0-6.8] ml) compared to VCV","[{'ForeName': 'Gianmaria', 'Initials': 'G', 'LastName': 'Cammarota', 'Affiliation': 'Anesthesia and General Intensive Care, ""Maggiore della Carità"" University Hospital, Novara, Italy. Electronic address: gmcamma@gmail.com.'}, {'ForeName': 'Erminio', 'Initials': 'E', 'LastName': 'Santangelo', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Lauro', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Verdina', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Boniolo', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Nello', 'Initials': 'N', 'LastName': 'De Vita', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Tarquini', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Spinelli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Garofalo', 'Affiliation': 'Department of Medical and Surgical Science, Università Magna Greacia, Catanzaro, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bruni', 'Affiliation': 'Department of Medical and Surgical Science, Università Magna Greacia, Catanzaro, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Zanoni', 'Affiliation': 'Anesthesia and General Intensive Care, ""Maggiore della Carità"" University Hospital, Novara, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Messina', 'Affiliation': 'Humanitas Clinical and Research Center - IRCCS - Rozzano, Milano, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Francesco Della', 'Initials': 'FD', 'LastName': 'Corte', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Navalesi', 'Affiliation': 'Department of Medicine, University of Padua, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Vaschetto', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Mauri', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",Journal of critical care,['10.1016/j.jcrc.2020.10.021']
2329,33157325,Effectiveness of antimicrobial photodynamic therapy as an adjunct to open flap debridement in patients with aggressive periodontitis.,"AIM
The aim of the present clinical trial was to evaluate the clinical efficacy of photodynamic therapy (PDT) as an adjunct to open flap debridement (OFD) in the treatment of generalized aggressive periodontitis (GAP).
MATERIALS AND METHODS
The subjects recruited for the study were divided into two groups: 'control group' received treatment through OFD, whereas the test participants were treated with OFD and adjunctive PDT. The clinical periodontal parameters were plaque index (PI), full mouth probing depth (FMPD) and full mouth relative attachment loss (FMRA). The microbial levels of Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg) and Tannarella forsythia (Tf) were analyzed. All parameters were assessed at baseline and 3 months.
STATISTICAL ANALYSIS
The observed values for all the parameters were reported in mean and standard deviation (mean ± SD). In order to analyse the mean values and inter-group comparisons, the Mann-Whitney U-test was employed. The p-value was set at <0.05 to establish a significant difference among the reported values.
RESULTS
A statistically significant improvement for BOP was observed in PDT group in comparison to the control group at 3 months only (p < 0.05). A significant reduction in the microbiological levels for Aa, Pg and Tf in both the study groups was observed. However, no significant differences in microbial levels were observed at any time point when the control and test groups were compared to each other.
CONCLUSION
PDT in conjuction with OFD plays a significant role in reducing the microbial load and improving the clinical periodontal parameters in patients with GAP. Moreover, it is regarded as a safe treatment regimen as PDT is non-toxic and no side effects have been reported regarding its use in GAP.",2020,A statistically significant improvement for BOP was observed in PDT group in comparison to the control group at 3 months only (p < 0.05).,"['patients with GAP', 'patients with aggressive periodontitis', 'generalized aggressive periodontitis (GAP']","['OFD and adjunctive PDT', 'photodynamic therapy (PDT', 'antimicrobial photodynamic therapy', ""control group' received treatment through OFD"", 'open flap debridement (OFD']","['clinical periodontal parameters', 'plaque index (PI), full mouth probing depth (FMPD) and full mouth relative attachment loss (FMRA', 'microbial levels', 'microbiological levels for Aa, Pg and Tf', 'microbial levels of Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg) and Tannarella forsythia (Tf', 'BOP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001342', 'cui_str': 'Acute periodontitis'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}, {'cui': 'C1018538', 'cui_str': 'Lian qiao'}, {'cui': 'C0085488', 'cui_str': 'Aggregatibacter actinomycetemcomitans'}, {'cui': 'C0085478', 'cui_str': 'Porphyromonas gingivalis'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}]",,0.0231565,A statistically significant improvement for BOP was observed in PDT group in comparison to the control group at 3 months only (p < 0.05).,"[{'ForeName': 'Nawwaf', 'Initials': 'N', 'LastName': 'Alhamoudi', 'Affiliation': 'Department of Periodontics and Community Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Mokeem', 'Affiliation': 'Department of Periodontics, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Syed Saad', 'Initials': 'SS', 'LastName': 'Shafqat', 'Affiliation': 'Ziauddin College of Dentistry, Ziauddin University, Karachi, Pakistan.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Vohra', 'Affiliation': 'Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Abduljabbar', 'Affiliation': 'Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University, Riyadh, Saudi Arabia. Electronic address: academicksa1@gmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.102075']
2330,33157330,The effectiveness of photodynamic and antibiotic gel therapy as an adjunct to mechanical debridement in the treatment of peri-implantitis among diabetic patients.,"AIM
The current clinical trial aimed to assess the effectiveness of adjunctive photodynamic therapy (aPDT) and adjunctive antibiotic gel therapy (aAGT) to treat peri-implantitis among patients with type 2 diabetes mellitus (T2DM).
METHODS
Selected T2DM participants with peri-implantitis were distributed into 3 groups: Group-1: received a single session of adjunctive (aPDT); Group-2: received a single session of adjunctive (aAGT) (metronidazole 400 mg and amoxicillin 500 mg); and Group-3: received MD alone. Clinical (probing depth [PD], bleeding on probing [BOP], and plaque scores [PS]) and radiographic (crestal bone loss [CBL]) peri-implant variables were recorded. Levels of interleukin (IL)-6 and tumor necrosis factor-alpha (TNF-α) were assessed after the collection of peri-implant sulcular fluid (PISF). All the evaluations were carried out at baseline, 3- and 6-months. The significance level was set to p < 0.05.
RESULTS
At 3-and 6-months of follow-up, all the three groups showed significant alleviation in PS (p < 0.05), BOP (p < 0.05), and PD (p < 0.05) when compared with the baseline. At baseline, no significant variation was observed in all clinical and radiographic peri-implant parameters among all three research groups. At 3-months follow-up, a considerable alleviation of in PS, BOP, PD, and CBL was noticeable in group-1 patients when compared with the baseline. At 6-months follow-up, a comparable difference was observed in BOP, PD, and CBL between group-1 and group-2. At baseline, no significant variation was observed in the PISF levels of IL-6 and TNF-α among all three research groups. At 3- and 6-months follow-up, a considerable alleviation of TNF-α and IL-6 levels was observed in group-1 and group-2 patients, respectively, when compared with the baseline.
CONCLUSION
The application of aPDT demonstrated improved clinical, radiographic, and immunological peri-implant parameters for the treatment of peri-implantitis among T2DM patients.",2020,"At baseline, no significant variation was observed in the PISF levels of IL-6 and TNF-α among all three research groups.","['Selected T2DM participants with peri-implantitis', 'diabetic patients', 'patients with type 2 diabetes mellitus (T2DM']","['single session of adjunctive (aPDT); Group-2: received a single session of adjunctive (aAGT) (metronidazole 400\u2009mg and amoxicillin 500\u2009mg); and Group-3: received MD alone', 'adjunctive photodynamic therapy (aPDT) and adjunctive antibiotic gel therapy (aAGT', 'photodynamic and antibiotic gel therapy']","['Levels of interleukin (IL)-6 and tumor necrosis factor-alpha (TNF-α', 'alleviation of in PS, BOP, PD, and CBL', 'alleviation in PS', 'BOP, PD, and CBL', 'PISF levels of IL-6 and TNF-α', 'TNF-α and IL-6 levels', 'BOP', 'Clinical (probing depth [PD], bleeding on probing [BOP], and plaque scores [PS]) and radiographic (crestal bone loss [CBL']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1128405', 'cui_str': 'Metronidazole 400 MG'}, {'cui': 'C0993263', 'cui_str': 'Amoxicillin 500 MG'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",,0.021103,"At baseline, no significant variation was observed in the PISF levels of IL-6 and TNF-α among all three research groups.","[{'ForeName': 'Paras', 'Initials': 'P', 'LastName': 'Ahmed', 'Affiliation': 'Oral Medicine Unit, School of Dental Sciences, Universiti Sains Malaysia, Kelantan, Malaysia.'}, {'ForeName': 'Ishfaq A', 'Initials': 'IA', 'LastName': 'Bukhari', 'Affiliation': 'Department of Pharmacology, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Refal', 'Initials': 'R', 'LastName': 'Albaijan', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Saeed A', 'Initials': 'SA', 'LastName': 'Sheikh', 'Affiliation': 'Department of Pharmacology, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Vohra', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh, Saudi Arabia. Electronic address: fvohra@ksu.edu.sa.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.102077']
2331,33157990,Tissue selecting technique mega-window stapler combined with anal canal epithelial preservation operation for the treatment of severe prolapsed hemorrhoids: A study protocol for a randomized controlled trial.,"INTRODUCTION
Hemorrhoidal disease is one of the most common and frequently occurring benign anorectal disorders, presented with bleeding and prolapsed, and surgery is the main and effective method for severe prolapsed hemorrhoids. Yet, the recurrence rate after procedure for prolapse and hemorrhoids (PPH) is significantly higher. To reduce the recurrence rate and protect the anus function, we try to carry out a randomized, controlled, prospective study to compare the efficacy and recurrence rate of tissue selecting technique (TST) with mega-window stapler (TST-MS) combined with anal canal epithelial preservation operation and PPH combined with external hemorrhoidectomy and inferior internal hemorrhoid ligation operation for the treatment of severe prolapsed hemorrhoids.
METHODS
This study is a single-center, evaluator-blinded, randomized, controlled clinical trial. Participants meet the inclusion and exclusion criteria in this RCT will be randomly divided into treatment group (TST-MS combined with anal canal epithelial preservation operation group) and control group (PPH combined with external hemorrhoidectomy and inferior internal hemorrhoid ligation operation) in a 1:1 ratio according to a computer-generated randomization list. The outcomes of recurrence, anal function, intraoperative variables, and postoperative complications will be recorded at different follow-ups.
CONCLUSION
The findings of the study will help to explore the efficacy and recurrence rate of TST-MS combined with anal canal epithelial preservation operation on the treatment of severe prolapsed hemorrhoids.
TRIAL REGISTRATION
This study protocol was registered in open science framework (OSF). (Registration number: DOI 10.17605 / OSF.IO / 4JYNF).",2020,"The outcomes of recurrence, anal function, intraoperative variables, and postoperative complications will be recorded at different follow-ups.
",['severe prolapsed hemorrhoids'],"['tissue selecting technique (TST) with mega-window stapler (TST-MS) combined with anal canal epithelial preservation operation and PPH combined with external hemorrhoidectomy and inferior internal hemorrhoid ligation operation', 'TST-MS combined with anal canal epithelial preservation operation', 'treatment group (TST-MS combined with anal canal epithelial preservation operation group) and control group (PPH combined with external hemorrhoidectomy and inferior internal hemorrhoid ligation operation', 'Tissue selecting technique mega-window stapler combined with anal canal epithelial preservation operation']","['recurrence rate', 'recurrence, anal function, intraoperative variables, and postoperative complications']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0227411', 'cui_str': 'Anal canal structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0193104', 'cui_str': 'Excision of external thrombotic hemorrhoid'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0265034', 'cui_str': 'Internal hemorrhoids'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0232722', 'cui_str': 'Anal function'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",,0.126082,"The outcomes of recurrence, anal function, intraoperative variables, and postoperative complications will be recorded at different follow-ups.
","[{'ForeName': 'Lijiang', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Anorectal Surgery, Changshu Hospital Affiliated to Nanjing University of Chinese Medicine, Changshu, Jiangsu Province.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Weng', 'Affiliation': 'Department of Anorectal Surgery, Changshu Hospital Affiliated to Nanjing University of Chinese Medicine, Changshu, Jiangsu Province.'}, {'ForeName': 'Yuemeng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Anorectal Surgery, Changshu Hospital Affiliated to Nanjing University of Chinese Medicine, Changshu, Jiangsu Province.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Anorectal Surgery, Changshu Hospital Affiliated to Nanjing University of Chinese Medicine, Changshu, Jiangsu Province.'}]",Medicine,['10.1097/MD.0000000000023122']
2332,33158001,Effectiveness of modeling videos on psychological responses of patients following anterior cruciate ligament reconstruction: A pilot randomized trial.,"BACKGROUND
To date, much of the rehabilitation following anterior cruciate ligament reconstruction (ACLR) has centered on physical components. However, clinical outcomes including return to sport after ACLR depends on not only physical recovery but also psychological components. This study was performed to assess the feasibility of 6-month modeling video intervention on psychological responses following ACLR.
METHODS
Following the baseline assessment of psychological measures through Knee Self Efficacy Scale (K-SES), ACL-Return to Sport after Injury (ACL-RSI), and Tampa Scale of Kinesiophobia-11 (TSK-11), 32 patients scheduled for ACLR were randomly assigned to intervention (n = 10), placebo (n = 11), or control (n = 11) group. Six modeling videos and placebo videos were developed by the investigators. Intervention and placebo groups watched their respective videos during their follow-up visits while control group did not. All groups completed psychological assessments during hospitalization, at 2 weeks, at 6 weeks, at 3 months, and at 6 months following ACLR. Also, Knee Injury and Osteoarthritis Outcome Score (KOOS) was used to evaluate symptoms and function of the knee at 3 and 6 months after surgery.
RESULTS
No significant changes in K-SES, ACL-RSI, and TSK-11 scores over 6-month period were observed among groups (P = .808, P = .574, P = .888, respectively). Compared with baseline, only the scores of K-SES improved with statistical significance in the intervention, placebo, and control groups (P = .05, .01, .00) at 6 months after ACLR. The KOOS subscale scores were not significantly different among the intervention, placebo, and control groups at 3 and 6 months.
CONCLUSION
A modeling video intervention, although feasible, was not effective in addressing the psychological risk factors in patients undergoing ACLR.",2020,"The KOOS subscale scores were not significantly different among the intervention, placebo, and control groups at 3 and 6 months.
","['32 patients scheduled for ACLR', 'patients following anterior cruciate ligament reconstruction', 'patients undergoing ACLR']","['Kinesiophobia-11 (TSK-11', 'anterior cruciate ligament reconstruction (ACLR', 'placebo', 'modeling videos', 'modeling video intervention']","['psychological responses', 'K-SES, ACL-RSI, and TSK-11 scores', 'KOOS subscale scores', 'scores of K-SES', 'Knee Injury and Osteoarthritis Outcome Score (KOOS', 'psychological measures through Knee Self Efficacy Scale (K-SES), ACL-Return to Sport after Injury (ACL-RSI), and Tampa Scale of']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0035127', 'cui_str': 'Repetitive strain injury'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",32.0,0.0273063,"The KOOS subscale scores were not significantly different among the intervention, placebo, and control groups at 3 and 6 months.
","[{'ForeName': 'Hye Chang', 'Initials': 'HC', 'LastName': 'Rhim', 'Affiliation': 'Department of Orthopaedic Surgery.'}, {'ForeName': 'Seo Jun', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery.'}, {'ForeName': 'Jin Sung', 'Initials': 'JS', 'LastName': 'Jeon', 'Affiliation': 'Department of Orthopaedic Surgery.'}, {'ForeName': 'Geun', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery.'}, {'ForeName': 'Kwang Yeol', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery.'}, {'ForeName': 'Jin Hyuck', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Sports Medical Center, Anam Hospital, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ki-Mo', 'Initials': 'KM', 'LastName': 'Jang', 'Affiliation': 'Department of Orthopaedic Surgery.'}]",Medicine,['10.1097/MD.0000000000023158']
2333,33158007,Frequent Anti-V1V2 Responses Induced by HIV-DNA Followed by HIV-MVA with or without CN54rgp140/GLA-AF in Healthy African Volunteers.,"Antibody responses that correlated with reduced risk of HIV acquisition in the RV144 efficacy trial were assessed in healthy African volunteers who had been primed three times with HIV-DNA (subtype A, B, C) and then randomized into two groups; group 1 was boosted twice with HIV-MVA (CRF01_AE) and group 2 with the same HIV-MVA coadministered with subtype C envelope (Env) protein (CN54rgp140/GLA-AF). The fine specificity of plasma Env-specific antibody responses was mapped after the final vaccination using linear peptide microarray technology. Binding IgG antibodies to the V1V2 loop in CRF01_AE and subtype C Env and Env-specific IgA antibodies were determined using enzyme-linked immunosorbent assay. Functional antibody-dependent cellular cytotoxicity (ADCC)-mediating antibody responses were measured using luciferase assay. Mapping of linear epitopes within HIV-1 Env demonstrated strong targeting of the V1V2, V3, and the immunodominant region in gp41 in both groups, with additional recognition of two epitopes located in the C2 and C4 regions in group 2. A high frequency of V1V2-specific binding IgG antibody responses was detected to CRF01_AE (77%) and subtype C antigens (65%). In conclusion, coadministration of CN54rgp140/GLA-AF with HIV-MVA did not increase the frequency, breadth, or magnitude of anti-V1V2 responses or ADCC-mediating antibodies induced by boosting with HIV-MVA alone.",2020,A high frequency of V1V2-specific binding IgG antibody responses was detected to CRF01_AE (77%) and subtype C antigens (65%).,"['Healthy African Volunteers', 'healthy African volunteers who had been primed three times with HIV-DNA (subtype A, B, C']","['HIV-MVA with or without CN54rgp140/GLA-AF', 'HIV-DNA', 'HIV-MVA (CRF01_AE) and group 2 with the same HIV-MVA coadministered with subtype C envelope (Env) protein (CN54rgp140/GLA-AF']","['risk of HIV acquisition', 'frequency, breadth, or magnitude of anti-V1V2 responses or ADCC-mediating antibodies', 'Functional antibody-dependent cellular cytotoxicity (ADCC)-mediating antibody responses', 'V1V2-specific binding IgG antibody responses']","[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0486959', 'cui_str': 'Human immunodeficiency virus DNA'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0052712', 'cui_str': 'AVM protocol'}, {'cui': 'C0486959', 'cui_str': 'Human immunodeficiency virus DNA'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0017278', 'cui_str': 'env Gene Products'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0003272', 'cui_str': 'Antibody-dependent cellular cytotoxicity'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]",,0.0286163,A high frequency of V1V2-specific binding IgG antibody responses was detected to CRF01_AE (77%) and subtype C antigens (65%).,"[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Msafiri', 'Affiliation': 'Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar es Salaam P.O. Box 65001, Tanzania.'}, {'ForeName': 'Agricola', 'Initials': 'A', 'LastName': 'Joachim', 'Affiliation': 'Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar es Salaam P.O. Box 65001, Tanzania.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Held', 'Affiliation': 'Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Nadai', 'Affiliation': 'Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.'}, {'ForeName': 'Raquel Matavele', 'Initials': 'RM', 'LastName': 'Chissumba', 'Affiliation': 'Instituto Nacional de Saúde, Maputo 3943, Mozambique.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Geldmacher', 'Affiliation': 'Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': 'Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar es Salaam P.O. Box 65001, Tanzania.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Stöhr', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Viegas', 'Affiliation': 'Instituto Nacional de Saúde, Maputo 3943, Mozambique.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Kroidl', 'Affiliation': 'Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, 80802 Munich, Germany.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Bakari', 'Affiliation': 'Department of Internal Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam P.O. Box 65001, Tanzania.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Munseri', 'Affiliation': 'Department of Internal Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam P.O. Box 65001, Tanzania.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Wahren', 'Affiliation': ""Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Nobel's Rd 16, 17177 Stockholm, Sweden.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Sandström', 'Affiliation': 'Karolinska Institutet at Södersjukhuset, Södersjukhuset, 11883 Stockholm, Sweden.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'The Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD 20817, USA.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'McCormack', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Joseph', 'Affiliation': 'Imperial College London, London SW10 9NH, UK.'}, {'ForeName': 'Ilesh', 'Initials': 'I', 'LastName': 'Jani', 'Affiliation': 'Instituto Nacional de Saúde, Maputo 3943, Mozambique.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Department of Surgery and Molecular Genetics and Microbiology, Duke University Medical Center, Durham, NC 27710, USA.'}, {'ForeName': 'Mangala', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': 'United States Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.'}, {'ForeName': 'Gunnel', 'Initials': 'G', 'LastName': 'Biberfeld', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, 17177 Stockholm, Sweden.'}, {'ForeName': 'Eligius', 'Initials': 'E', 'LastName': 'Lyamuya', 'Affiliation': 'Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar es Salaam P.O. Box 65001, Tanzania.'}, {'ForeName': 'Charlotta', 'Initials': 'C', 'LastName': 'Nilsson', 'Affiliation': 'Division of Clinical Microbiology, Department of Laboratory Medicine, Karolinska Institutet, 17177 Stockholm, Sweden.'}]",Microorganisms,['10.3390/microorganisms8111722']
2334,33158396,Deception detection and emotion recognition: Investigating F.A.C.E. software.,"Objective: Investigation of deception within psychotherapy has recently gained attention. Micro expression training software has been suggested to improve deception detection and enhance emotion recognition. The current study examined the effects of micro expression training software on deception detection and emotion recognition. Method: The current study recruited 23 counseling psychology graduate students and 32 undergraduate students and randomly assigned them to either a training group or a control group. The training and control group received all the same materials and measures pre- and post-test, with the training group differing by receiving the micro expression training. Results: Findings revealed no significant difference in deception detection between the control group and training group. The training did reveal significant improvement for emotion recognition, specifically in contempt, anger, and fear. State and trait anxiety did not predict deception detection nor did it mediate emotion recognition. No significant difference was found between graduate trainees and undergraduate students. Conclusion: The use of the F.A.C.E. software was not effective for increasing deception detection but did serve to increase emotion recognition. Implications for training, practice, and research are discussed.",2020,The use of the F.A.C.E. software was not effective for increasing deception detection but did serve to increase emotion recognition.,['23 counseling psychology graduate students and 32 undergraduate students'],"['training group or a control group', 'micro expression training software', 'training group differing by receiving the micro expression training']","['deception detection and enhance emotion recognition', 'deception detection', 'emotion recognition, specifically in contempt, anger, and fear', 'emotion recognition', 'Deception detection and emotion recognition', 'State and trait anxiety']","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0024195', 'cui_str': 'Deception'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C4704828', 'cui_str': 'Contempt'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.00986015,The use of the F.A.C.E. software was not effective for increasing deception detection but did serve to increase emotion recognition.,"[{'ForeName': 'Drew A', 'Initials': 'DA', 'LastName': 'Curtis', 'Affiliation': 'Department of Psychology and Sociology, Angelo State University, San Angelo, TX, USA.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1836424']
2335,33158412,Evaluating Recruitment Strategies for a Randomized Clinical Trial with Heart Failure Patients.,"Recruiting participants with chronic medical conditions is time-consuming and expensive. Electronic medical record databases and patient portals may enable outreach to larger numbers of patients in comparison to face-to-face methods. We aimed to describe the yields, benefits, and limitations of recruitment strategies used for a randomized clinical trial of cognitive behavioral therapy for insomnia among patients with chronic stable heart failure (NCT02660385). We used multiple recruitment strategies including clinic-based recruitment, letters to patients identified from electronic databases, the patient portal, brochures and posters placed in clinics, presentations to heart failure support groups, and online advertising. We screened 10,291 medical records, enrolled 231 participants, and 195 participants completed baseline data collection. We enrolled 92 (23%) participants using clinic-based recruitment, 24 and 29 (6% and 10%) using letters to patients from two electronic databases, and 42 (55%) via the patient portal. Multiple recruitment strategies and flexibility are needed to achieve recruitment goals.",2020,Electronic medical record databases and patient portals may enable outreach to larger numbers of patients in comparison to face-to-face methods.,"['Heart Failure Patients', 'We screened 10,291 medical records, enrolled 231 participants, and 195 participants completed baseline data collection', 'We enrolled 92 (23%) participants using clinic-based recruitment, 24 and 29 (6% and 10%) using letters to patients from two electronic databases, and 42 (55%) via the patient portal', 'patients with chronic stable heart failure (NCT02660385']",['cognitive behavioral therapy'],[],"[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C4277550', 'cui_str': 'Patient Portal'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],231.0,0.102142,Electronic medical record databases and patient portals may enable outreach to larger numbers of patients in comparison to face-to-face methods.,"[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Conley', 'Affiliation': 'Yale School of Nursing, Orange, CT, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': ""O'Connell"", 'Affiliation': 'Yale School of Nursing, Orange, CT, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Linsky', 'Affiliation': 'Yale School of Nursing, Orange, CT, USA.'}, {'ForeName': 'Lesa', 'Initials': 'L', 'LastName': 'Moemeka', 'Affiliation': 'Yale School of Nursing, Orange, CT, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Darden', 'Affiliation': 'Yale School of Nursing, Orange, CT, USA.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Gaiser', 'Affiliation': 'Yale School of Nursing, Orange, CT, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jacoby', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Yaggi', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Redeker', 'Affiliation': 'Yale School of Nursing, Orange, CT, USA.'}]",Western journal of nursing research,['10.1177/0193945920970229']
2336,33158419,Feasibility and success rates of response enhancing strategies in a stepwise prevention program for cardiometabolic diseases in primary care.,"BACKGROUND
Prevention programs for cardiometabolic diseases (CMD), including cardiovascular disease, diabetes mellitus and chronic kidney disease are feasible, but evidence for the cost-effectiveness of selective CMD prevention programs is lacking. Response rates have an important role in effectiveness, but methods to increase response rates have received insufficient attention. The aim of the current study is to determine the feasibility and the success rate of a variety of response enhancing strategies to increase the participation in a selective prevention program for CMD.
METHODS
The INTEGRATE study is a Dutch randomised controlled trial to assess the effectiveness and cost-effectiveness of a stepwise program for CMD prevention. During the INTEGRATE study we developed ten different response enhancing strategies targeted at different stages of non-response and different patient populations and evaluated these in 29 general practices.
RESULTS
A face-to-face reminder by the GP increased the response significantly. Digital reminders targeted at patients with an increased CMD risk showed a positive trend towards participation. Sending invitations and reminders by e-mail generated similar response rates, but at lower costs and time investment than the standard way of dissemination. Translated materials, information gatherings at the practice, self-management toolkits, reminders by telephone, information letters, local media attention and SMS text reminders did not increase the response to our program.
CONCLUSIONS
Inviting or reminding patients by e-mail or during GPs consultation may enhance response rates in a selective prevention program for CMD. Different response-enhancing strategies have different patient target populations and implementation issues, therefore practice characteristics need to be taken into account when implementing such strategies.
TRIAL REGISTRATION
Dutch trial Register number NTR4277 . Registered 26 November 2013.",2020,"Sending invitations and reminders by e-mail generated similar response rates, but at lower costs and time investment than the standard way of dissemination.",['cardiometabolic diseases in primary care'],[],['effectiveness and cost-effectiveness'],"[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0344832,"Sending invitations and reminders by e-mail generated similar response rates, but at lower costs and time investment than the standard way of dissemination.","[{'ForeName': 'Ilse F', 'Initials': 'IF', 'LastName': 'Badenbroek', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), P.O. Box 1568, 3500, BN, Utrecht, the Netherlands. I.F.Badenbroek@umcutrecht.nl.'}, {'ForeName': 'Marcus M J', 'Initials': 'MMJ', 'LastName': 'Nielen', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), P.O. Box 1568, 3500, BN, Utrecht, the Netherlands.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Hollander', 'Affiliation': 'JULIUS CENTER FOR HEALTH SCIENCES AND PRIMARY CARE, University Medical Center Utrecht, P.O. Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'Daphne M', 'Initials': 'DM', 'LastName': 'Stol', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), P.O. Box 1568, 3500, BN, Utrecht, the Netherlands.'}, {'ForeName': 'Roderik A', 'Initials': 'RA', 'LastName': 'Kraaijenhagen', 'Affiliation': 'NDDO Institute for Prevention and Early Diagnostics (NIPED), Naritaweg 70, 1043, BZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Niek J', 'Initials': 'NJ', 'LastName': 'de Wit', 'Affiliation': 'JULIUS CENTER FOR HEALTH SCIENCES AND PRIMARY CARE, University Medical Center Utrecht, P.O. Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'François G', 'Initials': 'FG', 'LastName': 'Schellevis', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), P.O. Box 1568, 3500, BN, Utrecht, the Netherlands.'}]",BMC family practice,['10.1186/s12875-020-01293-9']
2337,33158422,"Effectiveness of physical exercise for people with chronic diseases: the EFIKRONIK study protocol for a hybrid, clinical and implementation randomized trial.","BACKGROUND
Chronic illnesses are the leading cause of morbidity and mortality and threaten the sustainability of healthcare systems worldwide. There is limited evidence in terms of the best modality and intensity of physical activity for improving cardiorespiratory capacity and quality of life in patients with chronic conditions. The objective of the EfiKroniK study is to estimate the common effect of innovative, individualized and supervised physical exercise, on cardiorespiratory functional capacity and quality of life across people with different chronic conditions.
METHODS/DESIGN
This is a multicentre clinical trial with a type I hybrid effectiveness-implementation design, including 370 patients each with one of four different chronic illnesses: solid cancer, blood cancer, chronic obstructive pulmonary disease or schizophrenia. Patients will be randomly divided into two parallel groups, stratified by illness type. Patients in both groups will receive a standard healthy life prescription (PVS, from the Spanish ""Prescribe Vida Saludable"") and additionally, the EfiKroniK group will be prescribed a physical exercise programme tailored to each patient in terms of intensity in each session. The primary outcome variables will be cardiorespiratory functional capacity and quality of life. The secondary outcome variables will be signs and symptoms, psychological and social factors and specific laboratory parameters. We will also analyse the dose-response effect of the physical exercise programme. Qualitative variables will describe patients' perception of the utility and suitability of the EfiKroniK programme, as well as their expectations and satisfaction, identifying barriers to and facilitators of the EfiKroniK implementation process through discussion groups. The study will be carried out on an intention-to-treat basis, comparing changes throughout the 1-year follow-up between groups, adjusting for baseline, by performing mixed-effect analysis of covariance. We will estimate the effect of time on repeated measures in each subject and changes in the EfiKroniK and PVS groups over time.
DISCUSSION
The study will provide the data necessary to allow us to prescribe physical exercise in a similar way to a drug and as a key part of the treatment of chronic illnesses within our healthcare system.
TRIAL REGISTRATION
NCT03810755 . Date and version identifier: October 9, 2020. Version2.0.",2020,There is limited evidence in terms of the best modality and intensity of physical activity for improving cardiorespiratory capacity and quality of life in patients with chronic conditions.,"['370 patients each with one of four different chronic illnesses: solid cancer, blood cancer, chronic obstructive pulmonary disease or schizophrenia', 'patients with chronic conditions', 'people with chronic diseases', 'across people with different chronic conditions']","['standard healthy life prescription (PVS', 'physical exercise', 'physical exercise programme', 'EfiKroniK group will be prescribed a physical exercise programme']","['cardiorespiratory functional capacity and quality of life', 'signs and symptoms, psychological and social factors and specific laboratory parameters', 'cardiorespiratory capacity and quality of life']","[{'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0337460', 'cui_str': 'Social factor'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0676886,There is limited evidence in terms of the best modality and intensity of physical activity for improving cardiorespiratory capacity and quality of life in patients with chronic conditions.,"[{'ForeName': 'María Soledad', 'Initials': 'MS', 'LastName': 'Arietaleanizbeaskoa', 'Affiliation': 'Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain. MARIASOLEDAD.ARIETALEANIZBEASKOASARABIA@osakidetza.eus.'}, {'ForeName': 'Aintzane', 'Initials': 'A', 'LastName': 'Sancho', 'Affiliation': 'Medical Oncology Group, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Olazabal', 'Affiliation': 'Medical Hematology Group, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Concepcion', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'Medical Mental Health Group, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Erreka', 'Initials': 'E', 'LastName': 'Gil', 'Affiliation': 'Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Garcia-Alvarez', 'Affiliation': 'Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Nere', 'Initials': 'N', 'LastName': 'Mendizabal', 'Affiliation': 'Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Ibon', 'Initials': 'I', 'LastName': 'de la Fuente', 'Affiliation': 'Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Dominguez', 'Affiliation': 'Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Pablo', 'Affiliation': 'Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Grandes', 'Affiliation': 'Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC family practice,['10.1186/s12875-020-01298-4']
2338,33158423,"Oral neuromuscular training in patients with dysphagia after stroke: a prospective, randomized, open-label study with blinded evaluators.","BACKGROUND
Oral and pharyngeal swallowing dysfunction are common complications in acute stroke patients. This primary aim of this study was to determine whether oral neuromuscular training improves swallowing function in participants with swallowing dysfunction after stroke. A secondary aim was to assess how well results of the timed water-swallow test (TWST) correspond with swallowing dysfunction diagnosed by videofluoroscopy (VFS).
METHODS
This was an intention-to-treat two-centre prospective randomized open-label study with blinded-evaluators (PROBE) design. At 4 weeks after stroke onset, participants with swallowing dysfunction were randomized to 5 weeks of continued orofacial sensory-vibration stimulation with an electric toothbrush or additional oral neuromuscular training with an oral device (Muppy®). Participants were examined with TWST, a lip-force test, and VFS before (baseline), after 5 weeks' treatment (the end-of-treatment), and 12 months after treatment (follow-up). The baseline VFS results were compared with the TWST results. The primary endpoint was changes in swallowing rate assessed using TWST, from baseline to the end of training and from baseline to follow-up based on intention-to-treat analyses. The secondary endpoint was the corresponding changes in lip-force between baseline, the end of treatment, and follow-up.
RESULTS
The participants were randomly assigned as controls (n = 20) or for intervention with oral neuromuscular training (n = 20). After treatment, both groups had improved significantly (intervention, P < 0.001; controls, P = 0.001) in TWST but there was no significant between-group difference in swallowing rate. At the 12-month follow-up, the intervention group had improved further whereas the controls had deteriorated, and there were significant between-group differences in swallowing rate (P = 0.032) and lip force (P = 0.001). A TWST < 10 mL/sec at baseline corresponded to VFS-verified swallowing dysfunction in all assessed participants.
CONCLUSION
The 5-week oral neuromuscular training improved swallowing function in participants with post-stroke dysphagia compared with the controls 12 months after intervention, but there was no between-group difference in improvement immediately after treatment. TWST results corresponded with VFS results, making TWST a feasible method for identifying persons with swallowing dysfunction after stroke. Larger randomized controlled trials are required to confirm our preliminary positive long-term results.
TRIAL REGISTRATION
Retrospectively registered at ClinicalTrials.gov : NCT04164420 . Registered on 15 November 2019.",2020,"The 5-week oral neuromuscular training improved swallowing function in participants with post-stroke dysphagia compared with the controls 12 months after intervention, but there was no between-group difference in improvement immediately after treatment.","['participants with swallowing dysfunction after stroke', 'patients with dysphagia after stroke', 'acute stroke patients', 'persons with swallowing dysfunction after stroke', 'participants with swallowing dysfunction', 'participants with post-stroke dysphagia']","['timed water-swallow test (TWST', 'videofluoroscopy (VFS', 'Oral neuromuscular training', 'intervention with oral neuromuscular training', 'oral neuromuscular training', 'TWST', 'continued orofacial sensory-vibration stimulation with an electric toothbrush or additional oral neuromuscular training with an oral device (Muppy®']","['corresponding changes in lip-force', 'swallowing rate', 'swallowing rate assessed using TWST', 'swallowing function', 'VFS-verified swallowing dysfunction', 'lip force']","[{'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",,0.100683,"The 5-week oral neuromuscular training improved swallowing function in participants with post-stroke dysphagia compared with the controls 12 months after intervention, but there was no between-group difference in improvement immediately after treatment.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Hägglund', 'Affiliation': 'Department of Odontology, Oral and Maxillofacial Radiology, Umeå University, SE-90187, Umeå, Sweden. patricia.hagglund@umu.se.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hägg', 'Affiliation': 'Speech & Swallowing Centre, Department of Otorhinolaryngology, Hudiksvall Hospital, Hudiksvall, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Levring Jäghagen', 'Affiliation': 'Department of Odontology, Oral and Maxillofacial Radiology, Umeå University, SE-90187, Umeå, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Larsson', 'Affiliation': 'Department of Radiology, Hudiksvall Hospital, Hudiksvall, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Wester', 'Affiliation': 'Umeå Stroke Center, Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}]",BMC neurology,['10.1186/s12883-020-01980-1']
2339,33158424,Correction to: Integrated GP care for patients with persistent physical symptoms: feasibility cluster randomised trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['patients with persistent physical symptoms'],['Integrated GP care'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],[],,0.0446675,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Meenal', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'James', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neurosciences, Psychology and Neuroscience King's College, London, UK.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine King's College London, London, UK.""}, {'ForeName': 'Mujtaba', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'UK South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hotopf', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'David', 'Affiliation': 'Division of Psychiatry, Maple House, UCL Institute of Mental Health, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': 'Institute for Lifecourse Development, University of Greenwich, Old Royal Naval College, Park Row, Greenwich, London, SE10 9LS, UK.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neurosciences, Psychology and Neuroscience King's College, London, UK.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK. trudie.chalder@kcl.ac.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC family practice,['10.1186/s12875-020-01302-x']
2340,33157357,Effects of modified version of the Hospital Elder Life Program on post-discharge cognitive function and activities of daily living among older adults undergoing total knee arthroplasty.,"OBJECTIVES
This study aimed to investigate the effects of a modified Hospital Elder Life Program (mHELP) on post-discharge cognition and physical function among older adults undergoing total knee arthroplasty (TKA), and to evaluate the incidence of postoperative delirium.
DESIGN
Non-randomized intervention trial.
SETTING AND PARTICIPANTS
A total of 140 patients aged 60 years and older scheduled for elective orthopedic surgery at our institution between August 2017 and December 2018 were included.
METHODS
Ward-level stratification was used with one surgical ward receiving mHELP (intervention group), including orientation communication, early mobilization, vision/hearing impairment equipment, and dehydration prevention, and another ward providing usual care (control group). All participants were assigned to two surgical wards. Outcome measures were collected using MMSE telephone version (tMMSE), activities of daily living (ADL) and instrumental activities of daily living (IADL) instruments at 1, 6, and 12 months after discharge. Multiple linear regression analysis was used to measure effects of mHELP intervention on mean differences in tMMSE, ADL and IADL scores from baseline to 1-, 6- and 12-months.
RESULTS
Effects of mHELP intervention significantly preserved cognitive function at 1 and 12 months, but not at 6 months, compared with controls, regardless of adjustments for confounders. However, no intervention effects were noted in ADL and IADL scores. Postoperative delirium in the whole cohort was 3.6 % (2.5 % in intervention group, 5.1 % in control group, P = 0.41).
CONCLUSIONS
mHELP intervention preserves post-discharge cognitive function, but has no notable effect on ADL and IADL function in older adults undergoing elective TKA surgery.",2020,"Postoperative delirium in the whole cohort was 3.6 % (2.5 % in intervention group, 5.1 % in control group, P = 0.41).
","['older adults undergoing total knee arthroplasty', 'older adults undergoing elective TKA surgery', 'A total of 140 patients aged 60 years and older scheduled for elective orthopedic surgery at our institution between August 2017 and December 2018 were included', 'older adults undergoing total knee arthroplasty (TKA']","['modified version of the Hospital Elder Life Program', 'mHELP (intervention group), including orientation communication, early mobilization, vision/hearing impairment equipment, and dehydration prevention, and another ward providing usual care (control group', 'mHELP intervention', 'modified Hospital Elder Life Program (mHELP']","['MMSE telephone version (tMMSE), activities of daily living (ADL) and instrumental activities of daily living (IADL) instruments', 'tMMSE, ADL and IADL scores', 'ADL and IADL scores', 'cognitive function', 'Postoperative delirium']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}]",140.0,0.0811517,"Postoperative delirium in the whole cohort was 3.6 % (2.5 % in intervention group, 5.1 % in control group, P = 0.41).
","[{'ForeName': 'Chih-Kuang', 'Initials': 'CK', 'LastName': 'Liang', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Institute of Environmental and Occupational Health Sciences, School of Medicine, National Yang Ming University, Taipei, Taiwan; Aging and Health Research Center, National Yang Ming University, Taipei, Taiwan; Division of Neurology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Che-Sheng', 'Initials': 'CS', 'LastName': 'Chu', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Department of Psychiatry, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Ying-Hsin', 'Initials': 'YH', 'LastName': 'Hsu', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Division of Neurology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Chia Nan University of Pharmacy and Science, Tainan, Taiwan.'}, {'ForeName': 'Ming-Yueh', 'Initials': 'MY', 'LastName': 'Chou', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Aging and Health Research Center, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chun', 'Initials': 'YC', 'LastName': 'Wang', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Chia Nan University of Pharmacy and Science, Tainan, Taiwan.'}, {'ForeName': 'Yu-Te', 'Initials': 'YT', 'LastName': 'Lin', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Division of Neurology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Jenn-Huei', 'Initials': 'JH', 'LastName': 'Renn', 'Affiliation': 'Department of Orthopaedics, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Department of Medical Affair Administration, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Tsung-Yun', 'Initials': 'TY', 'LastName': 'Liu', 'Affiliation': 'Institute of Environmental and Occupational Health Sciences, School of Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Chang', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Institute of Environmental and Occupational Health Sciences, School of Medicine, National Yang Ming University, Taipei, Taiwan; Division of Clinical Toxicology & Occupational Medicine, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. Electronic address: ccyang@vghtpe.gov.tw.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104284']
2341,33157378,The effects of the Australian bushfires on physical activity in children.,"OBJECTIVES
To determine the impact of bushfires on children's physical activity.
DESIGN
Natural experiment comparing device-measured physical activity and air quality index data for schools exposed and not exposed to the Australian bushfires.
METHODS
Participants were drawn from 22 schools participating in a cluster randomised controlled trial of a school-based physical activity intervention that coincided with the 2019 Australian bushfires. Students in Years 3 and 4 (8-10 years old) provided data. We used propensity score matching to match 245 exposed and 344 control participants.
MAIN OUTCOME MEASURES
Minutes of moderate and vigorous physical activity.
RESULTS
The bushfires had minimal effect on children's average weekly physical activity. Analysis of acute effects showed children maintained their levels of physical activity up to an estimated turning point of air quality index of 737.08 (95% CI = 638.63, 835.53), beyond which daily physical activity levels dropped sharply. Similar results were found for girls and boys and for children from low-to-average and higher socio-economic backgrounds.
CONCLUSIONS
Children's physical activity was not strongly influenced by the presence of smoke and targeted public health advice during the bushfires might not have had the intended effect of reducing children's outdoor physical activity. Only when air quality deteriorated to approximately 3.5 times the Air Quality index threshold (>200) deemed 'hazardous' by the Australian Department of Health did children's physical activity decline. Public health agencies should re-evaluate the effectiveness of health messages during bushfires and develop strategies to mitigate risks to children's health.",2020,"Similar results were found for girls and boys and for children from low-to-average and higher socio-economic backgrounds.
","['344 control participants', 'schools exposed and not exposed to the Australian bushfires', 'Students in Years 3 and 4 (8-10\xa0years old) provided data', 'children', 'Participants were drawn from 22 schools participating in a cluster randomised controlled trial of a']",['school-based physical activity intervention'],"['Minutes of moderate and vigorous physical activity', 'daily physical activity levels', 'physical activity and air quality index data', 'physical activity']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2371710', 'cui_str': 'Air Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0469317,"Similar results were found for girls and boys and for children from low-to-average and higher socio-economic backgrounds.
","[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Del Pozo Cruz', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia. Electronic address: Borja.delPozoCruz@acu.edu.au.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Hartwig', 'Affiliation': 'Faculty of Health Sciences, School of Behavioural and Health Sciences, Australian Catholic University, New South Wales, Australia.'}, {'ForeName': 'Taren', 'Initials': 'T', 'LastName': 'Sanders', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Noetel', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia; School of Behavioural and Health Sciences, Australian Catholic University, Queensland, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Parker', 'Affiliation': 'Positive Psychology Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia.'}, {'ForeName': 'Devan', 'Initials': 'D', 'LastName': 'Antczak', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, Faculty of Education and Arts, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Bauman', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Cerin', 'Affiliation': 'Behaviour, Environment and Cognition Research Program, Mary Mackillop Institute for Health Research, Faculty of Health Sciences, Australian Catholic University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lonsdale', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia.'}]",Environment international,['10.1016/j.envint.2020.106214']
2342,33157398,Muscles and bare chests on Instagram: The effect of Influencers' fashion and fitspiration images on men's body image.,"Despite men using social media in increasing numbers, as yet there has been little research addressing effects on men's body image. The aim of the present study was to investigate the effect of exposure to idealized male Instagram images on men's body satisfaction. Participants were 300 men aged 18-30 years who were randomly assigned to view clothed (fashion) images, bare-chested (fitspiration) images, or control images of scenery, posted by the same male Instagram Influencers. It was found that exposure to bare-chested and muscular images resulted in significantly lower body satisfaction relative to viewing clothed fashion images or scenery images, which did not differ from each other. The clothed and bare-chested conditions did not differ in amount of appearance-based social comparison, nor in reported inspiration to exercise or eat healthily. Nor was there any moderation of effects by muscular-ideal internalization. It was concluded that although they are vulnerable to some types of social media imagery, results typically obtained for women cannot simply be generalized to men.",2020,"It was found that exposure to bare-chested and muscular images resulted in significantly lower body satisfaction relative to viewing clothed fashion images or scenery images, which did not differ from each other.","[""men's body image"", ""men's body satisfaction"", 'Participants were 300 men aged 18-30 years']","['view clothed (fashion) images, bare-chested (fitspiration) images, or control images of scenery, posted by the same male Instagram Influencers']",['Muscles and bare chests on Instagram'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]",300.0,0.0183932,"It was found that exposure to bare-chested and muscular images resulted in significantly lower body satisfaction relative to viewing clothed fashion images or scenery images, which did not differ from each other.","[{'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'School of Psychology, Flinders University, Australia. Electronic address: Marika.Tiggemann@flinders.edu.au.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Anderberg', 'Affiliation': 'School of Psychology, Flinders University, Australia.'}]",Body image,['10.1016/j.bodyim.2020.10.001']
2343,33157425,"Efficacy of melatonin for sleep disturbance in middle-aged primary insomnia: a double-blind, randomised clinical trial.","BACKGROUND
The aim of this study was to determine the efficacy of exogenous melatonin supplementation for sleep disturbances in patients with middle-aged primary insomnia.
METHODS
This is a randomized double-blind, placebo-controlled parallel study. Participants were recruited from Tianlin community, Xuhui district, Shanghai. Ninety-seven consecutive middle-aged patients with primary insomnia were randomized to receive 3 mg fast-release melatonin (n = 51) or placebo (n = 46) for four-weeks. Objective sleep parameters tested by overnight polysomnography, subjective sleep performance and daytime somnolence obtained from the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and Epworth Sleepiness Scale (ESS) were obtained at baseline and after treatment. Treatment was taken daily 1 h before bedtime. Serious adverse events and side-effects were monitored.
RESULTS
Melatonin supplementation significantly decreased early wake time [-30.63min (95% CI, -53.92 to -7.34); P = 0.001] and percentage of N2 sleep [-7.07% (95% CI, -13.47% to -0.68%); P = 0.031]. However, melatonin had no significant effect on other objective sleep parameters including sleep latency, sleep efficiency, wake during the sleep and percent of N1, N3 and REM sleep. Melatonin had no effect on insomnia symptoms and severity on the PSQI [1.53(95% CI, -0.55 to 3.61); p = 0.504]; ISI [0.81 (95% CI, -2.27 to 3.88); p = 0.165] and ESS [-0.83 (95% CI, -3.53 to 1.88); p = 0.147]. No serious adverse events were reported.
CONCLUSIONS
Melatonin supplementation over a four-week period is effective and safe in improving some aspects of objective sleep quality such as total sleep time, percentage of rapid eye movement and early morning wake time in middle-aged patients with insomnia.
TRIAL REGISTRATION
Identifier: ChiCTR-TRC-13003997; Prospectively registered on 2 December 2013.",2020,"RESULTS
Melatonin supplementation significantly decreased early wake time [-30.63min (95% CI, -53.92 to -7.34); P = 0.001] and percentage of N2 sleep [-7.07% (95% CI, -13.47% to -0.68%);","['Ninety-seven consecutive middle-aged patients with primary insomnia', 'patients with middle-aged primary insomnia', 'middle-aged patients with insomnia', 'middle-aged primary insomnia', 'Participants were recruited from Tianlin community, Xuhui district, Shanghai']","['melatonin', 'exogenous melatonin supplementation', 'Melatonin supplementation', 'placebo', 'Melatonin', '3\xa0mg fast-release melatonin']","['insomnia symptoms and severity on the PSQI', 'Serious adverse events and side-effects', 'objective sleep parameters including sleep latency, sleep efficiency, wake during the sleep and percent of N1, N3 and REM sleep', 'sleep disturbances', 'early wake time', 'sleep disturbance', 'overnight polysomnography, subjective sleep performance and daytime somnolence obtained from the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and Epworth Sleepiness Scale (ESS', 'percentage of N2 sleep', 'serious adverse events']","[{'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0541798', 'cui_str': 'Terminal insomnia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C2219848', 'cui_str': 'Daytime somnolence'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C4704917', 'cui_str': 'NREM Stage 2'}]",97.0,0.518584,"RESULTS
Melatonin supplementation significantly decreased early wake time [-30.63min (95% CI, -53.92 to -7.34); P = 0.001] and percentage of N2 sleep [-7.07% (95% CI, -13.47% to -0.68%);","[{'ForeName': 'Huajun', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Chujun', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Yingjun', 'Initials': 'Y', 'LastName': 'Qian', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Jianyin', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Yupu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Huaming', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China. Electronic address: zhmtiger@126.com.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Suru', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Weitian', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China. Electronic address: drzhangwt@163.com.""}, {'ForeName': 'Hongliang', 'Initials': 'H', 'LastName': 'Yi', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China. Electronic address: guanjian0606@sina.com.""}, {'ForeName': 'Zhengnong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Shankai', 'Initials': 'S', 'LastName': 'Yin', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}]",Sleep medicine,['10.1016/j.sleep.2020.10.018']
2344,33158038,"Implementation of a Delayed Prescribing Model to Reduce Antibiotic Prescribing for Suspected Upper Respiratory Tract Infections in a Hospital Outpatient Department, Ghana.","Background : High levels of antimicrobial resistance (AMR) in Ghana require the exploration of new approaches to optimise antimicrobial prescribing. This study aims to establish the feasibility of implementation of different delayed/back-up prescribing models on antimicrobial prescribing for upper respiratory tract infections (URTIs). Methods : This study was part of a quality improvement project at LEKMA Hospital, Ghana, (Dec 2019-Feb 2020). Patients meeting inclusion criteria were assigned to one of four groups (Group 0: No prescription given; Group 1; Patient received post-dated antibiotic prescription; Group 2: Offer of a rapid reassessment of patient by a nurse practitioner after 3 days; and Group 3: Post-dated prescription forwarded to hospital pharmacy). Patients were contacted 10 days afterwards to ascertain wellbeing and actions taken, and patients were asked rate the service on a Likert scale. Post-study informal discussions were conducted with hospital staff. Results: In total, 142 patients met inclusion criteria. Groups 0, 1, 2 and 3 had 61, 16, 44 and 21 patients, respectively. Common diagnosis was sore throat (73%). Only one patient took antibiotics after 3 days. Nearly all (141/142) patients were successfully contacted on day 10, and of these, 102 (72%) rated their experiences as good or very good. Informal discussions with staff revealed improved knowledge of AMR. Conclusions: Delayed/back-up prescribing can reduce antibiotic consumption amongst outpatient department patients with suspected URTIs. Delayed/back-up prescribing can be implemented safely in low and middle-income countries (LMICs).",2020,This study aims to establish the feasibility of implementation of different delayed/back-up prescribing models on antimicrobial prescribing for upper respiratory tract infections (URTIs). ,"['outpatient department patients with suspected URTIs', 'Ghana', 'Suspected Upper Respiratory Tract Infections in a Hospital Outpatient Department, Ghana', '142 patients met inclusion criteria']","['antimicrobial resistance (AMR', 'No prescription given; Group 1; Patient received post-dated antibiotic prescription; Group 2: Offer of a rapid reassessment of patient by a nurse practitioner after 3 days; and Group 3: Post-dated prescription forwarded to hospital pharmacy']","['Antibiotic', 'antibiotic consumption', 'knowledge of AMR']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032993', 'cui_str': 'Post-term pregnancy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",,0.0359313,This study aims to establish the feasibility of implementation of different delayed/back-up prescribing models on antimicrobial prescribing for upper respiratory tract infections (URTIs). ,"[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Ghebrehewet', 'Affiliation': 'Public Health England North West Health Protection Team, Liverpool L3 1JR, UK.'}, {'ForeName': 'Wendi', 'Initials': 'W', 'LastName': 'Shepherd', 'Affiliation': 'Public Health England North West Health Protection Team, Liverpool L3 1JR, UK.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Panford-Quainoo', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool L3 5QA, UK.'}, {'ForeName': 'Saran', 'Initials': 'S', 'LastName': 'Shantikumar', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry CV4 7HL, UK.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Decraene', 'Affiliation': 'Public Health England National Infection Service, Liverpool L3 1JR, UK.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Rajendran', 'Affiliation': 'Mid Cheshire NHS Foundation Trust, Crewe CW1 4QJ, UK.'}, {'ForeName': 'Menaal', 'Initials': 'M', 'LastName': 'Kaushal', 'Affiliation': 'LEKMA Hospital, Accra, Ghana.'}, {'ForeName': 'Afua', 'Initials': 'A', 'LastName': 'Akuffo', 'Affiliation': 'LEKMA Hospital, Accra, Ghana.'}, {'ForeName': 'Dinah', 'Initials': 'D', 'LastName': 'Ayerh', 'Affiliation': 'LEKMA Hospital, Accra, Ghana.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Amofah', 'Affiliation': 'LEKMA Hospital, Accra, Ghana.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9110773']
2345,33158040,Larotrectinib versus Prior Therapies in Tropomyosin Receptor Kinase Fusion Cancer: An Intra-Patient Comparative Analysis.,"Randomized controlled basket trials investigating drugs targeting a rare molecular alteration are challenging. Using patients as their own control overcomes some of these challenges. Growth modulation index (GMI) is the ratio of progression-free survival (PFS) on the current therapy to time to progression (TTP) on the last prior line of therapy; GMI ≥ 1.33 is considered a threshold of meaningful clinical activity. In a retrospective, exploratory analysis among patients with advanced tropomyosin receptor kinase (TRK) fusion cancer treated with the selective TRK inhibitor larotrectinib who received ≥1 prior line of therapy for locally advanced/metastatic disease, we determined the proportion of patients with GMI ≥ 1.33; patients who had not progressed by data cut-off were censored for PFS. Among 72 eligible patients, median GMI was 2.68 (range 0.01-48.75). Forty-seven patients (65%) had GMI ≥ 1.33; 13/25 patients (52%) with GMI < 1.33 had not yet progressed on larotrectinib. Kaplan-Meier estimates showed a median GMI of 6.46. The probability of attaining GMI ≥ 1.33 was 0.75 (95% confidence interval (CI), 0.65-0.85). Median TTP on previous treatment was 3.0 months (95% CI, 2.6-4.4). Median PFS on larotrectinib was not estimable ((NE); 95% CI, NE; hazard ratio, 0.220 (95% CI, 0.146-0.332)). This analysis suggests larotrectinib improves PFS for patients with TRK fusion cancer compared with prior therapy.",2020,"Median TTP on previous treatment was 3.0 months (95% CI, 2.6-4.4).","['patients with TRK fusion cancer', 'patients with advanced tropomyosin receptor kinase (TRK) fusion cancer treated with the selective TRK inhibitor larotrectinib who received ≥1 prior line of therapy for locally advanced/metastatic disease, we determined the proportion of patients with GMI ≥ 1.33; patients who had not progressed by data cut-off were censored for PFS']","['Larotrectinib versus Prior Therapies', 'GMI']","['Growth modulation index (GMI', 'median GMI', 'Median TTP', 'Median PFS on larotrectinib']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041197', 'cui_str': 'Tropomyosin'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4524315', 'cui_str': 'larotrectinib'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4517500', 'cui_str': '1.33'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C1518543', 'cui_str': 'Off'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]","[{'cui': 'C4524315', 'cui_str': 'larotrectinib'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4524315', 'cui_str': 'larotrectinib'}]",72.0,0.0822019,"Median TTP on previous treatment was 3.0 months (95% CI, 2.6-4.4).","[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Italiano', 'Affiliation': 'Early Phase Trials Unit, Institut Bergonie, 33000 Bordeaux, France.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Nanda', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ 07981, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'London School of Hygiene & Tropical Medicine, Bloomsbury, London WC1E 7HT, UK.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Garcia-Foncillas', 'Affiliation': 'OncoHealth Institute, University Hospital Fundación Jiménez Díaz, 28040 Madrid, Spain.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Lassen', 'Affiliation': 'Department of Oncology, Rigshospitalet, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Vassal', 'Affiliation': 'Institut Gustave Roussy, 94800 Villejuif Cedex, France.'}, {'ForeName': 'Shivaani', 'Initials': 'S', 'LastName': 'Kummar', 'Affiliation': 'Stanford Cancer Institute, Stanford University, Palo Alto, CA 94304, USA.'}, {'ForeName': 'Cornelis M', 'Initials': 'CM', 'LastName': 'van Tilburg', 'Affiliation': ""Hopp Children's Cancer Center Heidelberg (KiTZ), Heidelberg University Hospital and German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany.""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Hong', 'Affiliation': 'Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.'}, {'ForeName': 'Theodore W', 'Initials': 'TW', 'LastName': 'Laetsch', 'Affiliation': ""Department of Pediatrics and Harold C, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center/Children's Health, Dallas, TX 75390, USA.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Keating', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ 07981, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Reeves', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ 07981, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fellous', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ 07981, USA.'}, {'ForeName': 'Barrett H', 'Initials': 'BH', 'LastName': 'Childs', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ 07981, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Drilon', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Hyman', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}]",Cancers,['10.3390/cancers12113246']
2346,33158079,Prospective Evaluation of Mango Fruit Intake on Facial Wrinkles and Erythema in Postmenopausal Women: A Randomized Clinical Pilot Study.,"Mangos are rich in β-carotene and other carotenoids, along with several phenolic acids that may provide oxidant defense and photoprotection to the skin. The objectives of this study are to investigate the effects of Ataulfo mango intake on the development of facial wrinkles and erythema. A randomized two-group parallel-arm study was conducted to assess 16 weeks of either 85 g or 250 g of mango intake in healthy postmenopausal women with Fitzpatrick skin type II or III. Facial photographs were captured at weeks 0, 8, and 16, and wrinkles at the lateral canthi and erythema at the cheeks were quantified. Skin carotenoid values were measured with reflection spectroscopy. Deep wrinkle severity decreased significantly in the 85 g group after 8 ( p = 0.007) and 16 ( p = 0.03) weeks compared to baseline measures. In contrast, those in the 250 g group showed an increase after 16 weeks in average wrinkle severity ( p = 0.049), average wrinkle length ( p = 0.007), fine wrinkle severity ( p = 0.02), and emerging wrinkle severity ( p = 0.02). Erythema in the cheeks increased with 85 g of mango intake ( p = 0.04). The intake of 85 g of mangos reduced wrinkles in fair-skinned postmenopausal women, while an intake of 250 g showed the opposite effect. Further studies feeding 85 g of mangos are warranted.",2020,Deep wrinkle severity decreased significantly in the 85 g group after 8 ( p = 0.007) and 16 ( p = 0.03) weeks compared to baseline measures.,"['Postmenopausal Women', 'healthy postmenopausal women with Fitzpatrick skin type II or III']","['Mango Fruit Intake', 'Ataulfo mango intake']","['facial wrinkles and erythema', 'Deep wrinkle severity', 'Erythema', 'fine wrinkle severity', 'Facial Wrinkles and Erythema', 'average wrinkle length', 'Skin carotenoid values', 'emerging wrinkle severity', 'average wrinkle severity']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0440284', 'cui_str': 'Mango fruit'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0330955', 'cui_str': 'Mangifera indica'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0487652,Deep wrinkle severity decreased significantly in the 85 g group after 8 ( p = 0.007) and 16 ( p = 0.03) weeks compared to baseline measures.,"[{'ForeName': 'Vivien W', 'Initials': 'VW', 'LastName': 'Fam', 'Affiliation': 'Department of Nutrition, UC Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Roberta R', 'Initials': 'RR', 'LastName': 'Holt', 'Affiliation': 'Department of Nutrition, UC Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Carl L', 'Initials': 'CL', 'LastName': 'Keen', 'Affiliation': 'Department of Nutrition, UC Davis, Davis, CA 95616, USA.'}, {'ForeName': 'Raja K', 'Initials': 'RK', 'LastName': 'Sivamani', 'Affiliation': 'Department of Dermatology, UC Davis, Sacramento, CA 95816, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Hackman', 'Affiliation': 'Department of Nutrition, UC Davis, Davis, CA 95616, USA.'}]",Nutrients,['10.3390/nu12113381']
2347,33158080,Adverse Event Burden Score-A Versatile Summary Measure for Cancer Clinical Trials.,"This article introduces the adverse event (AE) burden score. The AE burden by treatment cycle is a weighted sum of all grades and AEs that the patient experienced in a cycle. The overall AE burden score is the total AE burden the patient experienced across all treatment cycles. AE data from two completed Alliance multi-center randomized double-blind placebo-controlled trials, with different AE profiles (NCCTG 97-24-51: 176 patients, and A091105: 83 patients), were utilized for illustration. Results of the AE burden score analyses corroborated the trials' primary results. In 97-24-51, the overall AE burden for patients on the treatment arm was 2.2 points higher than those on the placebo arm, with a higher AE burden for patients who went off treatment early due to AE. Similarly, in A091105, the overall AE burden was 1.6 points higher on the treatment arm. On the placebo arms, the AE burden in 97-24-51 remained constant over time; and increased in later cycles in A091105, likely attributable to the increase in disease morbidity. The AE burden score enables statistical comparisons analogous to other quantitative endpoints in clinical trials, and can readily accommodate different trial settings, diseases, and treatments, with diverse AE profiles.",2020,"On the placebo arms, the AE burden in 97-24-51 remained constant over time; and increased in later cycles in A091105, likely attributable to the increase in disease morbidity.","['controlled trials, with different AE profiles (NCCTG 97-24-51: 176 patients, and A091105: 83 patients']",['placebo'],"['overall AE burden', 'disease morbidity', 'overall AE burden score', 'AE burden', 'adverse event (AE) burden score']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.45265,"On the placebo arms, the AE burden in 97-24-51 remained constant over time; and increased in later cycles in A091105, likely attributable to the increase in disease morbidity.","[{'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Le-Rademacher', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA.'}, {'ForeName': 'Shauna', 'Initials': 'S', 'LastName': 'Hillman', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Storrick', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Mahoney', 'Affiliation': 'IQVIA, Raleigh-Durham, NC 27703, USA.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Thall', 'Affiliation': 'Department of Biostatistics, M.D. Anderson Cancer Center, Houston, TX 77230, USA.'}, {'ForeName': 'Aminah', 'Initials': 'A', 'LastName': 'Jatoi', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, MN 55905, USA.'}, {'ForeName': 'Sumithra J', 'Initials': 'SJ', 'LastName': 'Mandrekar', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA.'}]",Cancers,['10.3390/cancers12113251']
2348,33158101,Effects of the Preschool-Based Family-Involving DAGIS Intervention on Family Environment: A Cluster Randomised Trial.,"Interventions promoting young children's healthy energy balance-related behaviours (EBRBs) should also examine changes in the family environment as this is an important determinant that may affect the effectiveness of the intervention. This study examines family environmental effects of the Increased Health and Wellbeing in Preschools (DAGIS) intervention study, and whether these effects differed when considering three parental educational level (PEL) groups. The DAGIS intervention was conducted in preschools and involving parents in Southern Finland from September 2017 to May 2018. It was designed as a randomised trial, clustered at preschool-level. Parents of 3-6-year-olds answered questionnaires recording PEL, parental role modelling for EBRBs, and the family environment measured as EBRBs availability and accessibility. Linear Mixed Models with Repeated Measures were used in order to detect intervention effects. Models included group by time interactions. When examining intervention effects separated by PEL groups, models with three-level interactions (group × time-points × PEL) were evaluated. There was an interaction effect for the availability of sugary everyday foods and drinks ( p = 0.002). The analyses showed that the control group increased availability ( p = 0.003), whereas in the intervention group no changes were detected ( p = 0.150). In the analysis separated by PEL groups, changes were found only for the accessibility of sugary treats at home; the high PEL control group increased the accessibility of sugary treats ( p = 0.022) (interaction effect: p = 0.027). Hence, results suggest that the DAGIS multicomponent intervention had a limited impact on determinants for children's healthy EBRBs, and no impact was found in the low PEL group.",2020,There was an interaction effect for the availability of sugary everyday foods and drinks ( p = 0.002).,"['preschools and involving parents in Southern Finland from September 2017 to May 2018', ""young children's healthy energy balance-related behaviours (EBRBs"", 'Family Environment']",['Preschool-Based Family-Involving DAGIS Intervention'],"['availability', 'EBRBs availability and accessibility', 'accessibility of sugary treats']","[{'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",,0.0423531,There was an interaction effect for the availability of sugary everyday foods and drinks ( p = 0.002).,"[{'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Ray', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Rejane', 'Initials': 'R', 'LastName': 'Figueiredo', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Riikka', 'Initials': 'R', 'LastName': 'Pajulahti', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Henna', 'Initials': 'H', 'LastName': 'Vepsäläinen', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66, FI-00014 Helsinki, Finland.'}, {'ForeName': 'Elviira', 'Initials': 'E', 'LastName': 'Lehto', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Reetta', 'Initials': 'R', 'LastName': 'Lehto', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}, {'ForeName': 'Maijaliisa', 'Initials': 'M', 'LastName': 'Erkkola', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66, FI-00014 Helsinki, Finland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Roos', 'Affiliation': 'Folkhälsan Research Center, Topeliuksenkatu 20, FI-00250 Helsinki, Finland.'}]",Nutrients,['10.3390/nu12113387']
2349,33158705,Practice-Based Learning Using Smart Class: A Competency-Based Model in Undergraduate Radiology Education.,"RATIONALE AND OBJECTIVES
A need for adequate and early exposure to radiology practice is rising in undergraduate students, taking competency development as the orientation. We aimed to develop a competency-based model of practice-based learning for undergraduate radiology education.
MATERIALS AND METHODS
The model of practice-based learning was constructed upon an e-learning smart class environment, with case-based learning and simulators for competency development. To assess the model effectiveness, a randomized controlled experiment was performed, where 57 third-year medical students received the model (Smart-Class group) and another 57 received traditional teaching (Traditional group). Seven quizzes, a final exam, and a survey were performed in both groups.
RESULTS
Smart-Class group achieved higher mean score in the quizzes (r = -0.4, p < 0.001) and application subscore in the final exam (r = -0.3, p = 0.005) compared to Traditional group. Smart-Class group also gave higher ratings in students' perceptions concerning promotion of learning interests, radiology skills, and diagnostic reasoning (r = -0.2 to -0.3, p = 0.001-0.034).
CONCLUSION
Practice-based learning using smart class improved students' application ability and satisfactions in undergraduate radiology education, suggesting it a practical model for early exposure to radiology practice and competency development for undergraduate medical students.",2020,"RESULTS
Smart-Class group achieved higher mean score in the quizzes (r = -0.4, p < 0.001) and application subscore in the final exam (r = -0.3, p = 0.005) compared to Traditional group.","['undergraduate students', 'undergraduate medical students', '57 third-year medical students received the']","['Practice-Based Learning Using Smart Class', 'model (Smart-Class group) and another 57 received traditional teaching (Traditional group']","['learning interests, radiology skills, and diagnostic reasoning', 'application subscore']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0185125', 'cui_str': 'Application'}]",,0.0133076,"RESULTS
Smart-Class group achieved higher mean score in the quizzes (r = -0.4, p < 0.001) and application subscore in the final exam (r = -0.3, p = 0.005) compared to Traditional group.","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No.37 Guoxue Alley, Chengdu 610041, Sichuan, China; Teaching and Research Office of Medical Imaging, West China School of Medicine, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Zixing', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No.37 Guoxue Alley, Chengdu 610041, Sichuan, China; Teaching and Research Office of Medical Imaging, West China School of Medicine, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Jianqun', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No.37 Guoxue Alley, Chengdu 610041, Sichuan, China; Teaching and Research Office of Medical Imaging, West China School of Medicine, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Qing', 'Affiliation': 'Department of Medical Education, West China Medical Center, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Lui', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No.37 Guoxue Alley, Chengdu 610041, Sichuan, China; Teaching and Research Office of Medical Imaging, West China School of Medicine, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Rongbo', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No.37 Guoxue Alley, Chengdu 610041, Sichuan, China; Teaching and Research Office of Medical Imaging, West China School of Medicine, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': 'Operation Management Department, West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Academic Affairs Department, West China School of Medicine, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Yaning', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': 'Academic Affairs Department, West China School of Medicine, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ""President's Office, West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No.37 Guoxue Alley, Chengdu 610041, Sichuan, China; Teaching and Research Office of Medical Imaging, West China School of Medicine, Sichuan University, Chengdu 610041, Sichuan, China. Electronic address: nahu_wch@163.com.'}]",Academic radiology,['10.1016/j.acra.2020.09.028']
2350,33158765,A Phase II Trial of Nivolumab With Chemotherapy Followed by Maintenance Nivolumab in Patients With Pleural Mesothelioma After Surgery: The NICITA Study Protocol.,"BACKGROUND
In selected patients with early-stage malignant pleural mesothelioma (MPM), a multimodal therapy that includes surgical cytoreduction, chemotherapy, and/or radiotherapy is recommended. Several clinical trials have demonstrated the beneficial effects of immune checkpoint inhibitors in pretreated MPM patients with advanced disease. Recent clinical data have suggested that the combination of chemotherapy and checkpoint inhibition might improve efficacy.
TRIAL DESIGN
The NICITA (nivolumab with chemotherapy in pleural mesothelioma after surgery) trial is a prospective, 1:1 randomized, open-label, multicenter phase II clinical trial (ClinicalTrials.gov identifier, NCT04177953). Ninety-two patients with MPM epithelioid subtype, who had undergone extended pleurectomy and decortication with or without hyperthermic intrathoracic chemoperfusion, will be included to receive adjuvant treatment. All patients will receive ≤ 4 cycles of platinum-based chemotherapy with pemetrexed (arms A and B). Patients in arm B will additionally receive nivolumab, together with the adjuvant chemotherapy, and subsequently for ≤ 12 cycles as maintenance therapy. The primary endpoint of this study is the time-to-next-treatment. The secondary endpoints include progression-free survival, overall survival, proportion of patients with treatment beyond progression, duration of treatment beyond progression in this population, and quality of life.
CONCLUSION
This prospective trial will contribute data to assess the efficacy of standard chemotherapy combined with nivolumab in the context of multimodal management of early-stage MPM. The study is currently enrolling patients.",2020,"The secondary endpoints include progression-free survival, overall survival, proportion of patients with treatment beyond progression, duration of treatment beyond progression in this population, and quality of life.
","['pretreated MPM patients with advanced disease', 'selected patients with early-stage malignant pleural mesothelioma (MPM', 'Patients With Pleural Mesothelioma', 'Ninety-two patients with MPM epithelioid subtype, who had undergone extended pleurectomy and decortication with or without hyperthermic intrathoracic chemoperfusion', 'early-stage MPM']","['NICITA (nivolumab with chemotherapy', 'standard chemotherapy combined with nivolumab', 'platinum-based chemotherapy with pemetrexed', 'Nivolumab With Chemotherapy', 'nivolumab, together with the adjuvant chemotherapy']","['progression-free survival, overall survival, proportion of patients with treatment beyond progression, duration of treatment beyond progression in this population, and quality of life', 'time-to-next-treatment']","[{'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0152463', 'cui_str': 'Pleurectomy'}, {'cui': 'C0007778', 'cui_str': 'Brain decortication'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0595836', 'cui_str': 'Intrathoracic route'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",92.0,0.0698954,"The secondary endpoints include progression-free survival, overall survival, proportion of patients with treatment beyond progression, duration of treatment beyond progression in this population, and quality of life.
","[{'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Department of Thoracic Oncology/Internal Medicine, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany; Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany. Electronic address: rajiv.shah@med.uni-heidelberg.de.'}, {'ForeName': 'Laura V', 'Initials': 'LV', 'LastName': 'Klotz', 'Affiliation': 'Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany; Department of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Inn', 'Initials': 'I', 'LastName': 'Chung', 'Affiliation': 'Department of Thoracic Oncology/Internal Medicine, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany; Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Feißt', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Schneider', 'Affiliation': 'Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany; Translational Research Unit, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Riedel', 'Affiliation': 'Institute of Clinical Cancer Research IKF at Northwest Hospital GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Bischoff', 'Affiliation': 'Department of Thoracic Oncology/Internal Medicine, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany; Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'Eichhorn', 'Affiliation': 'Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany; Department of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Department of Thoracic Oncology/Internal Medicine, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany; Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.10.005']
2351,33158772,Quality of Life Effect of the Anti-CCR4 Monoclonal Antibody Mogamulizumab Versus Vorinostat in Patients With Cutaneous T-cell Lymphoma.,"BACKGROUND
Sézary syndrome (SS) and mycosis fungoides (MF), 2 types of cutaneous T-cell lymphoma, cause significant morbidity and adversely affect patients' quality of life (QoL). The present study assessed the QoL measurement changes in patients receiving mogamulizumab versus vorinostat.
PATIENTS AND METHODS
A multicenter phase III trial was conducted of patients with stage IB-IV MF/SS with ≥ 1 failed systemic therapy. The QoL measures included Skindex-29 and the Functional Assessment of Cancer Therapy-General. The symptoms, function, and QoL subdomains were longitudinally modeled using mixed models with prespecified covariates. Meaningful change thresholds (MCTs) were defined using distribution-based methods. The categorical changes by group over time and the time to clinically meaningful worsening were analyzed.
RESULTS
Of the 372 randomized patients, mogamulizumab demonstrated improvement in Skindex-29 symptoms (cycles 3, 5, and 7; P < .05) and functional (cycles 3 and 5; P < .05) scales. A significantly greater proportion of mogamulizumab-treated patients improved by MCTs or more from baseline in the Skindex-29 symptoms domain (cycles 3, 5, 7, and 11) and functioning domain (cycle 5). Significant differences in the Functional Assessment of Cancer Therapy-General physical well-being (cycles 1, 3, and 5; P < .05) were observed in favor of mogamulizumab and a greater proportion of patients had declined by MCTs or more at cycles 1, 3, 5, and 7 with vorinostat treatment. The median time to symptom worsening using Skindex-29 was 27.4 months for mogamulizumab versus 6.6 months for vorinostat. In the patients with SS, the time to worsening favored mogamulizumab (P < .005) for all Skindex-29 domains. The time to worsening was similar for the 2 MF treatment arms.
CONCLUSION
The symptoms, function, and overall QoL of patients with MF/SS favored mogamulizumab over vorinostat across all time points. Patients with the greatest symptom burden and functional impairment derived the most QoL benefit from mogamulizumab.",2020,"In the patients with SS, the time to worsening favored mogamulizumab (P < .005) for all Skindex-29 domains.","['Patients With Cutaneous T-cell Lymphoma', 'patients with stage IB-IV MF/SS with\xa0≥ 1 failed systemic therapy', 'patients receiving mogamulizumab versus vorinostat']",['Anti-CCR4 Monoclonal Antibody Mogamulizumab Versus Vorinostat'],"['QoL measurement changes', 'time to worsening favored mogamulizumab', 'symptoms, function, and QoL subdomains', 'median time to symptom worsening', 'symptoms, function, and overall QoL', 'time to worsening', 'Meaningful change thresholds (MCTs', 'Functional Assessment of Cancer Therapy-General physical well-being', 'Skindex-29 symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079773', 'cui_str': 'Cutaneous T-cell lymphoma'}, {'cui': 'C0456597', 'cui_str': 'Stage 1B'}, {'cui': 'C0026948', 'cui_str': 'Mycosis fungoides'}, {'cui': 'C0036920', 'cui_str': 'Sezary syndrome'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2987603', 'cui_str': 'mogamulizumab'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}]","[{'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C2987603', 'cui_str': 'mogamulizumab'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C2987603', 'cui_str': 'mogamulizumab'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C5197672', 'cui_str': 'Symptom Exaggeration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",372.0,0.0481385,"In the patients with SS, the time to worsening favored mogamulizumab (P < .005) for all Skindex-29 domains.","[{'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Porcu', 'Affiliation': 'Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Department of Medical Oncology, Sidney Kimmel Center, Thomas Jefferson University, Philadelphia, PA. Electronic address: pierluigi.porcu@jefferson.edu.'}, {'ForeName': 'Stacie', 'Initials': 'S', 'LastName': 'Hudgens', 'Affiliation': 'Clinical Outcomes Solutions, Tucson, AZ.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Horwitz', 'Affiliation': 'Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Quaglino', 'Affiliation': 'Department of Medical Sciences, Dermatologic Clinic, University of Turin, Turin, Italy.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Cowan', 'Affiliation': 'Cancer Research UK - Christie Hospital Foundation NHS Trust, Manchester, UK.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Geskin', 'Affiliation': 'Department of Dermatology, New York Presbyterian Hospital, New York, NY.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Beylot-Barry', 'Affiliation': 'CHU de Bordeaux - Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Lysbeth', 'Initials': 'L', 'LastName': 'Floden', 'Affiliation': 'Clinical Outcomes Solutions, Tucson, AZ.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Bagot', 'Affiliation': 'Service de Dermatologie, Hôpital Saint Louis, Paris, France.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Tsianakas', 'Affiliation': 'Department of Dermatology, Specialist Clinic Bad Bentheim, Bad Bentheim, Germany.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Moskowitz', 'Affiliation': 'Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Auris', 'Initials': 'A', 'LastName': 'Huen', 'Affiliation': 'Department of Dermatology, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dreno', 'Affiliation': 'Onco-Dermatology Department, CHU de Nantes - Nantes Hospital, Nantes, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Immucare, Hospices Civils de Lyon, Cancer Research Center of Lyon, Lyon University, Pierre-Bénite, France.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Caballero', 'Affiliation': 'Servicio de Hematología, Hospital Clínico Universitario de Salamanca, Salamanca, Spain.'}, {'ForeName': 'Mollie', 'Initials': 'M', 'LastName': 'Leoni', 'Affiliation': 'Kyowa Kirin Pharmaceutical Development, Inc, Princeton, NJ.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Dale', 'Affiliation': 'Kyowa Kirin Pharmaceutical Development, Inc, Princeton, NJ.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Herr', 'Affiliation': 'Kyowa Kirin, Inc, Bedminster, NJ.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Duvic', 'Affiliation': 'Department of Dermatology, University of Texas MD Anderson Cancer Center, Houston, TX.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2020.09.003']
2352,33158819,Protocol for a feasibility study of smoking cessation in the surgical pathway before major lung surgery: Project MURRAY.,"INTRODUCTION
Smoking prior to major thoracic surgery is the biggest risk factor for development of postoperative pulmonary complications, with one in five patients continuing to smoke before surgery. Current guidance is that all patients should stop smoking before elective surgery yet very few are offered specialist smoking cessation support. Patients would prefer support within the thoracic surgical pathway. No study has addressed the effectiveness of such an intervention in this setting on cessation. The overall aim is to determine in patients who undergo major elective thoracic surgery whether an intervention integrated (INT) into the surgical pathway improves smoking cessation rates compared with usual care (UC) of standard community/hospital based NHS smoking support. This pilot study will evaluate feasibility of a substantive trial.
METHODS AND ANALYSIS
Project MURRAY is a trial comparing the effectiveness of INT and UC on smoking cessation. INT is pharmacotherapy and a hybrid of behavioural support delivered by the trained healthcare practitioners (HCPs) in the thoracic surgical pathway and a complimentary web-based application. This pilot study will evaluate the feasibility of a substantive trial and study processes in five adult thoracic centres including the University Hospitals Birmingham NHS Foundation Trust. The primary objective is to establish the proportion of those eligible who agree to participate. Secondary objectives include evaluation of study processes. Analyses of feasibility and patient-reported outcomes will take the form of simple descriptive statistics and where appropriate, point estimates of effects sizes and associated 95% CIs.
ETHICS AND DISSEMINATION
The study has obtained ethical approval from NHS Research Ethics Committee (REC number 19/WM/0097). Dissemination plan includes informing patients and HCPs; engaging multidisciplinary professionals to support a proposal of a definitive trial and submission for a full application dependent on the success of the study.
TRIAL REGISTRATION NUMBER
NCT04190966.",2020,This pilot study will evaluate the feasibility of a substantive trial and study processes in five adult thoracic centres including the University Hospitals Birmingham NHS Foundation Trust.,"['patients who undergo major elective thoracic surgery whether an', 'five adult thoracic centres including the University Hospitals Birmingham NHS Foundation Trust']","['intervention integrated (INT', 'INT and UC', 'usual care (UC) of standard community/hospital based NHS smoking support', 'smoking cessation', 'Smoking prior to major thoracic surgery']",['smoking cessation rates'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0237935', 'cui_str': 'Trust'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.0523317,This pilot study will evaluate the feasibility of a substantive trial and study processes in five adult thoracic centres including the University Hospitals Birmingham NHS Foundation Trust.,"[{'ForeName': 'Sebastian T', 'Initials': 'ST', 'LastName': 'Lugg', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kerr', 'Affiliation': 'Department of Thoracic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Kadiri', 'Affiliation': 'Department of Thoracic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Alina-Maria', 'Initials': 'AM', 'LastName': 'Budacan', 'Affiliation': 'Department of Thoracic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farley', 'Affiliation': 'Insitute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Perski', 'Affiliation': 'Institute of Epidemiology & Health, University College London, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Institute of Epidemiology & Health, University College London, London, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Institute of Epidemiology & Health, University College London, London, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Thickett', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Babu', 'Initials': 'B', 'LastName': 'Naidu', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK b.naidu@bham.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036568']
2353,33159163,Effect of fish-oil supplementation on breastmilk long-chain polyunsaturated fatty acid concentration: a randomized controlled trial in rural Ethiopia.,"BACKGROUND
For infants and young children in low-income settings, human milk (HM) is the main source of omega-3 (n-3) long-chain polyunsaturated fatty acids (LCPs), including docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). However, the n-3 LCPs concentrations of HM show wide variability, largely depending on the maternal intake of marine foods. This may put children living far from coastal areas at risk of inadequate intake. We evaluated the efficacy of fish-oil (FO) supplementation of lactating mothers on HM n-3 LCPs concentrations in a rural setting from Ethiopia.
METHODS
Mothers (n = 360) with children 6-12 months old were randomized to receive either intervention FO capsules (215 mg DHA + 285 mg EPA) or control corn-oil capsules (without n-3 LCPs). In a random subsample of 154 participants, we analyzed LCPs in HM and child capillary blood using gas chromatography.
RESULTS
Compared to the control, FO supplementation increased HM concentrations of DHA by 39.0% (95% CI: 20.6, 57.5%; P < 0.001) and EPA by 36.2% (95% CI: 16.0, 56.4%; P < 0.001), whereas the arachidonic acid (AA)/(DHA + EPA) ratio decreased by 53.5% (95% CI: -70.2, -36.7%; P < 0.001). We also found statistically significant association between the changes in (DHA + EPA)/AA ratio in HM and child capillary blood (P < 0.001). However, HM DHA concentrations remained lower than international norms after FO supplementation.
CONCLUSIONS
FO supplementation improves n-3 LCPs content of HM. Future studies should evaluate different doses of n-3 LCPs and consider potential effect modifiers such as genetic polymorphism and diet. This trial was registered at clinicaltrials.gov as NCT01817634.",2020,"Compared to the control, FO supplementation increased HM concentrations of DHA by 39.0% (95% CI: 20.6, 57.5%; P < 0.001) and EPA by 36.2% (95% CI: 16.0, 56.4%; P < 0.001), whereas the arachidonic acid (AA)/(DHA + EPA) ratio decreased by 53.5% (95% CI: -70.2, -36.7%; P < 0.001).","['lactating mothers on HM n-3 LCPs concentrations in a rural setting from Ethiopia', 'infants and young children in low-income settings, human milk (HM', '154 participants, we analyzed LCPs in HM and child capillary blood using gas chromatography', 'Mothers (n\u2009=\u2009360) with children 6-12 months old', 'rural Ethiopia']","['FO supplementation', 'intervention FO capsules (215\u2009mg DHA\u2009+\u2009285\u2009mg EPA) or control corn-oil capsules (without n-3 LCPs', 'fish-oil (FO) supplementation', 'fish-oil supplementation', 'docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA', 'n-3 LCPs']","['changes in (DHA\u2009+\u2009EPA)/AA ratio in HM and child capillary blood', 'EPA', 'HM DHA concentrations', 'arachidonic acid (AA)/(DHA\u2009+\u2009EPA) ratio', 'n-3 LCPs content of HM', 'HM concentrations of DHA', 'breastmilk long-chain polyunsaturated fatty acid concentration']","[{'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0008555', 'cui_str': 'Gas chromatography measurement'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",360.0,0.293107,"Compared to the control, FO supplementation increased HM concentrations of DHA by 39.0% (95% CI: 20.6, 57.5%; P < 0.001) and EPA by 36.2% (95% CI: 16.0, 56.4%; P < 0.001), whereas the arachidonic acid (AA)/(DHA + EPA) ratio decreased by 53.5% (95% CI: -70.2, -36.7%; P < 0.001).","[{'ForeName': 'Alemayehu', 'Initials': 'A', 'LastName': 'Argaw', 'Affiliation': 'Department of Population and Family Health, Institute of Health, Jimma University, Jimma, Ethiopia. yemariamwork2@gmail.com.'}, {'ForeName': 'Kimberley P', 'Initials': 'KP', 'LastName': 'Bouckaert', 'Affiliation': 'Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Mekitie', 'Initials': 'M', 'LastName': 'Wondafrash', 'Affiliation': 'Department of Population and Family Health, Institute of Health, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kolsteren', 'Affiliation': 'Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Lachat', 'Affiliation': 'Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'De Meulenaer', 'Affiliation': 'Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Hanley-Cook', 'Affiliation': 'Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Lieven', 'Initials': 'L', 'LastName': 'Huybregts', 'Affiliation': 'Poverty, Health and Nutrition Division, International Food Policy Research Institute, Washington, DC, USA.'}]",European journal of clinical nutrition,['10.1038/s41430-020-00798-x']
2354,33159177,Comparative study of 1 DD and 2 DD radius conventional internal limiting membrane peeling in large idiopathic full-thickness macular holes: a randomized controlled trial.,"OBJECTIVE
To compare the surgical outcomes of 1-disc diameter (DD) and 2-DD conventional internal limiting membrane peeling (C-ILMP) in large full-thickness macular holes (FTMHs).
MATERIALS AND METHODS
A prospective randomized controlled trial. One hundred patients with large idiopathic full-thickness macular hole (FTMH) were randomized into C-ILMP and extended C-ILMP (EC-ILMP) groups. The primary outcome was closure rate at 6 months after surgery. Secondary outcomes were visual acuity (VA), closure type, consequence of ILMP and complications.
RESULTS
The mean symptom duration was 12.19 ± 9.64 months. Mean preoperative VA was 1.25 ± 0.37 logMAR. The average minimum linear diameter was 633.05 ± 129.82 µm and basal linear dimension was 1158.49 ± 249.07 µm. The two groups did not differ in term of demographic data. Closure rate was significantly higher in the EC-ILMP group (76.47% vs. 51.02%, 95% CI 7.24-43.66; p = 0.008). There were also no significant differences in closure type, central foveal thickness, dissociated optic nerve fibre layer detection, or change in fovea-to-disc distance. There were also no significant differences in postoperative VA (p = 0.069) or visual improvement (mean 0.39 ± 0.43 logMAR; p = 0.286). According to subgroup analysis, EC-ILMP resulted in a higher closure rate in patients with chronic FTMH for >6 months, (p = 0.008). Furthermore, EC-ILMP resulted in better anatomical closure and visual result in patients with FTMH with macular hole closure index ≤0.5, p = 0.003 and p = 0.010, respectively.
CONCLUSION
Extended C-ILMP yielded a significantly higher closure rate in large FTMHs, but visual outcome did not differ significantly. According to subgroup analysis, extended C-ILMP was more effective in chronic large FTMH with MHCI ≤ 0.5.",2020,"Closure rate was significantly higher in the EC-ILMP group (76.47% vs. 51.02%, 95% CI 7.24-43.66;","['large idiopathic full-thickness macular holes', 'One hundred patients with large idiopathic full-thickness macular hole (FTMH']","['C-ILMP and extended C-ILMP (EC-ILMP', 'EC-ILMP', 'DD and 2 DD radius conventional internal limiting membrane peeling', '1-disc diameter (DD) and 2-DD conventional internal limiting membrane peeling (C-ILMP']","['visual acuity (VA), closure type, consequence of ILMP and complications', 'mean symptom duration', 'closure type, central foveal thickness, dissociated optic nerve fibre layer detection, or change in fovea-to-disc distance', 'anatomical closure and visual result', 'postoperative VA', 'Closure rate', 'closure rate', 'visual improvement']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C2733564', 'cui_str': 'Full thickness hole of macula lutea'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1275949', 'cui_str': 'Disc diameter'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0029130', 'cui_str': 'Optic nerve structure'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016622', 'cui_str': 'Structure of fovea centralis'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",100.0,0.254534,"Closure rate was significantly higher in the EC-ILMP group (76.47% vs. 51.02%, 95% CI 7.24-43.66;","[{'ForeName': 'Suthasinee', 'Initials': 'S', 'LastName': 'Sinawat', 'Affiliation': 'KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand. ssuthasinee@kku.ac.th.'}, {'ForeName': 'Parinya', 'Initials': 'P', 'LastName': 'Srihatrai', 'Affiliation': 'Department of Ophthalmology, Suddhavej Hospital, Mahasarakham University, Mahasarakham, Thailand.'}, {'ForeName': 'Plern', 'Initials': 'P', 'LastName': 'Sutra', 'Affiliation': 'Department of Ophthalmology, Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand.'}, {'ForeName': 'Yosanan', 'Initials': 'Y', 'LastName': 'Yospaiboon', 'Affiliation': 'KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Supat', 'Initials': 'S', 'LastName': 'Sinawat', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}]","Eye (London, England)",['10.1038/s41433-020-01259-2']
2355,33159220,A novel decision aid for acute myeloid leukemia: a feasibility and preliminary efficacy trial.,"PURPOSE
Acute myeloid leukemia (AML) is a hematologic malignancy characterized by a poor prognosis but also a paradoxical possibility of cure. This renders decision-making complex and imminent. Unfortunately, many patients with AML misestimate their prognosis and treatment risk. While decision aids can improve illness understanding and reduce decisional conflict, there are no validated decision aids for AML. We developed and tested a novel AML decision aid (NCT03442452).
METHODS
Patients (n = 20) were recruited at Duke University from May 2018 to February 2019. Participants completed assessments of AML knowledge and decisional conflict, before and after using the electronic decision aid. The primary endpoint was feasibility (endpoint met if > 80% of study participants completed all study components). Secondary analyses of efficacy were conducted using paired t tests for dependent pre-/post-samples.
RESULTS
The primary endpoint of feasibility was met (100% of participants completed all study components). Secondary analyses showed improved knowledge and reduced decisional conflict after using the decision aid. Knowledge scores improved from a mean of 11.8 (out of 18) correct items at baseline to 15.1 correct items after using the decision aid (mean difference 3.35; p < 0.0001). Decisional conflict scores reduced significantly from baseline to post-test as well (mean difference - 6.5; p = 0.02).
CONCLUSION
These findings suggest that our AML decision aid is a useful tool to improve the patient experience and promote shared decision-making in AML. A randomized efficacy trial is planned.",2020,"Decisional conflict scores reduced significantly from baseline to post-test as well (mean difference - 6.5; p = 0.02).
","['acute myeloid leukemia', 'Patients (n = 20) were recruited at Duke University from May 2018 to February 2019']",[],"['knowledge and reduced decisional conflict', 'Knowledge scores', 'Decisional conflict scores', 'AML knowledge and decisional conflict']","[{'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1512090', 'cui_str': 'Dukes staging system'}, {'cui': 'C0041740', 'cui_str': 'University'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]",20.0,0.151092,"Decisional conflict scores reduced significantly from baseline to post-test as well (mean difference - 6.5; p = 0.02).
","[{'ForeName': 'Jordan D', 'Initials': 'JD', 'LastName': 'Hildenbrand', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Debra M', 'Initials': 'DM', 'LastName': 'Davis', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Kris W', 'Initials': 'KW', 'LastName': 'Herring', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Locke', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Department of Population Health Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Samsa', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Steinhauser', 'Affiliation': 'Department of Population Health Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Jesse D', 'Initials': 'JD', 'LastName': 'Troy', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ubel', 'Affiliation': 'Sanford School of Public Policy, Duke University, Durham, NC, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Leblanc', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC, USA. thomas.leblanc@duke.edu.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05864-5']
2356,33159256,Effect of mizoribine pulse therapy in adult membranous nephropathy.,"Membraneous nephropathy (MN) is one of the complicated kidney diseases associated with proteinuria. Mizoribine (MZR) is an emerging treatment option for nephrotic syndrome; however, its dosage and administration are yet lack of consensus. This study aims to evaluate the efficacy and safety of high-dose MZR pulse therapy for adult membraneous nephropathy. Sixty patients with membraneous nephropathy were recruited, and assigned to two treatment groups. One group received conventional treatment of steroid combining with cyclophosphamide (CPM), the other group received steroid combining with high-dose MZR pulse administration. Both groups were followed up for 1 year. Treatment efficacy and side effects were measured regularly. Fifty-nine patients completed the treatment courses. There was no significant difference in demographic and disease conditions prior to treatment between two treatment groups. Both groups showed significant decrease of urine proteins and increase of serum albumin levels after treatments with no severe side effects. After 6 months of treatment, MZR group has 71% reduction (compared to 74.4% reduction in CPM group) in urine protein compared to baseline after adjusting for age and gender. 89.7% of patients in CPM and 93.3% in MZR groups had partial/ complete remission after 12 months. This study demonstrated satisfactory safety and efficacy of high-dose mizoribine pulse administration combining with steroid treatment for adult patients with membranous nephropathy.",2020,"After 6 months of treatment, MZR group has 71% reduction (compared to 74.4% reduction in CPM group) in urine protein compared to baseline after adjusting for age and gender.","['Sixty patients with membraneous nephropathy', 'adult membraneous nephropathy', 'nephrotic syndrome', 'adult patients with membranous nephropathy', 'adult membranous nephropathy']","['high-dose MZR pulse therapy', 'MZR', 'mizoribine pulse administration combining with steroid treatment', 'steroid combining with high-dose MZR pulse administration', 'conventional treatment of steroid combining with cyclophosphamide (CPM', 'Mizoribine (MZR', 'mizoribine pulse therapy']","['efficacy and safety', 'serum albumin levels', 'partial/ complete remission', 'satisfactory safety and efficacy', 'Treatment efficacy and side effects', 'urine proteins', 'demographic and disease conditions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic syndrome'}, {'cui': 'C0017665', 'cui_str': 'Membranous glomerulonephritis'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0128608', 'cui_str': 'Mizoribine'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0262923', 'cui_str': 'Urine protein test'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",60.0,0.0271305,"After 6 months of treatment, MZR group has 71% reduction (compared to 74.4% reduction in CPM group) in urine protein compared to baseline after adjusting for age and gender.","[{'ForeName': 'Xichao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Tianjin First Central Hospital, No.24 Fukang Road, Tianjin, 300192, China.'}, {'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Tianjin First Central Hospital, No.24 Fukang Road, Tianjin, 300192, China.'}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Tianjin First Central Hospital, No.24 Fukang Road, Tianjin, 300192, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, Tianjin First Central Hospital, No.24 Fukang Road, Tianjin, 300192, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Nephrology, Tianjin First Central Hospital, No.24 Fukang Road, Tianjin, 300192, China.'}, {'ForeName': 'Wenxiu', 'Initials': 'W', 'LastName': 'Chang', 'Affiliation': 'Department of Nephrology, Tianjin First Central Hospital, No.24 Fukang Road, Tianjin, 300192, China. ccxichao@sina.com.'}]",International urology and nephrology,['10.1007/s11255-020-02680-y']
2357,33159283,Using gel for difficult mask ventilation on the bearded patients: a simulation-based study.,"The beard is a well-known cause of difficult mask ventilation due to excessive air leaks. Various techniques have been proposed to overcome this difficulty, such as applying a gel on the mask edge. Our objective was to determine whether the gel technique will improve ventilation and to assess the comfort of the provider. A randomized crossover design was conducted to assess the efficacy of gel in a bearded simulation model. Respiratory therapists (RT) were recruited by convenience sampling to hold the mask using a two-handed technique for a two-minute ventilation session. During the session, the ventilator provided a fixed Tidal Volume (TV) of 550 mL and a respiratory rate of 12 per minute, and the simulated model measured the received volumes. We compared the median TV and number of failed ventilation attempts with or without the gel. The comfort level while using the gel was assessed with constructed questions. We recruited 74 respiratory therapists working in Riyadh city. More than half of the participants had more than 5 years experience. The median tidal volume for standard mask ventilation without the gel was 283 mL [interquartile range (IQR) 224, 327], whereas that with the gel was 467 mL [451, 478], respectively (p < 0.01). The number of successful ventilations was recorded out of 24 breaths during the 2-min ventilation period for each technique; the proportion of successful ventilations increased significantly by 65% (95% CI 51-75%, p < 0.01) with the gel. In addition, only nine participants believed the technique was not comfortable, while the remaining individuals found it comfortable or natural. In our bearded simulation model, applying the gel significantly improved ventilation without negatively affecting comfort. Further studies and education are encouraged in the field of basic airway management.",2020,"In our bearded simulation model, applying the gel significantly improved ventilation without negatively affecting comfort.","['74 respiratory therapists working in Riyadh city', 'bearded patients']",[],"['median TV and number of failed ventilation attempts', 'comfort level', 'median tidal volume', 'number of successful ventilations', 'proportion of successful ventilations']","[{'cui': 'C1709924', 'cui_str': 'Respiratory therapist'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0221982', 'cui_str': 'Structure of beard'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",,0.0311398,"In our bearded simulation model, applying the gel significantly improved ventilation without negatively affecting comfort.","[{'ForeName': 'Saqer M', 'Initials': 'SM', 'LastName': 'Althunayyan', 'Affiliation': 'Department of Accident and Trauma, Prince Sultan Bin Abdulaziz College for Emergency Medical Services, King Saud University, Riyadh, Kingdom of Saudi Arabia. salthunayyan@KSU.EDU.SA.'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Mubarak', 'Affiliation': 'Department of Basic Science, Prince Sultan Bin Abdulaziz College for Emergency Medical Services, King Saud University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Raied N', 'Initials': 'RN', 'LastName': 'Alotaibi', 'Affiliation': 'Department of Basic Science, Prince Sultan Bin Abdulaziz College for Emergency Medical Services, King Saud University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Musab Z', 'Initials': 'MZ', 'LastName': 'Alharthi', 'Affiliation': 'Department of Accident and Trauma, Prince Sultan Bin Abdulaziz College for Emergency Medical Services, King Saud University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Aljanoubi', 'Affiliation': 'Department of Aviation and Marines, Prince Sultan Bin Abdulaziz College for Emergency Medical Services, King Saud University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Sulaiman', 'Initials': 'S', 'LastName': 'Alshabanat', 'Affiliation': 'Respiratory Care Services, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Abdulmajeed M', 'Initials': 'AM', 'LastName': 'Mobrad', 'Affiliation': 'Department of Emergency Medical Services, Prince Sultan Bin Abdulaziz College for Emergency Medical Services, King Saud University, Riyadh, Kingdom of Saudi Arabia.'}]",Internal and emergency medicine,['10.1007/s11739-020-02547-1']
2358,33159309,A comprehensive reconstruction strategy for moderate to severe faciocervical scar contractures.,"The focus of treatment of faciocervical scar contractures includes cervical reconstruction and elimination of hypertrophic scars. Unfortunately, most previous studies have neglected the esthetic appearance of scars. In this study, we tried to combine surgical therapy and ultrapulse fractional CO 2 laser (UFCL) to eliminate facial scars while restoring neck reconstruction and to establish the optimal conventional management for faciocervical contracture. Thirty-eight individuals were enrolled and divided into two groups. After received cervical release surgeries, comprehensive UFCL therapy group received treatment of UFCL at 3-month intervals, silicone sheets, and pressure garments, while another group only received treatment of silicone sheeting and compression. Twelve months after the termination of therapy, faciocervical scars of both two groups were assessed by two uninvolved physicians according to the Vancouver Scar Scale (VSS), and patients' satisfaction survey was also recorded by the study participants using a patient four-point satisfaction scale. Thirty-six patients completed the treatment and follow-up. The results show that the VSS scores of both two groups decreased after 12 months, but comprehensive UFCL therapy group dropped more significantly than the conventional treatment group at follow-up session, which was statistically significant (P < 0.001), and the patient satisfaction was higher than that of the conventional treatment group. This comprehensive treatment combined of surgery, UFCL, silicone sheets, and pressure garments works as an effective and esthetic reconstruction for moderate to severe postburn faciocervical scar contractures.",2020,"The results show that the VSS scores of both two groups decreased after 12 months, but comprehensive UFCL therapy group dropped more significantly than the conventional treatment group at follow-up session, which was statistically significant (P < 0.001), and the patient satisfaction was higher than that of the conventional treatment group.","['Thirty-eight individuals', 'moderate to severe faciocervical scar contractures']","['faciocervical scar contractures', 'UFCL at 3-month intervals, silicone sheets, and pressure garments, while another group only received treatment of silicone sheeting and compression', 'cervical release surgeries, comprehensive UFCL therapy', 'surgery, UFCL, silicone sheets, and pressure garments works', 'combine surgical therapy and ultrapulse fractional CO 2 laser (UFCL']","['faciocervical scars', ""Vancouver Scar Scale (VSS), and patients' satisfaction survey"", 'VSS scores', 'patient satisfaction']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C1283059', 'cui_str': 'Pressure garments'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",38.0,0.0111513,"The results show that the VSS scores of both two groups decreased after 12 months, but comprehensive UFCL therapy group dropped more significantly than the conventional treatment group at follow-up session, which was statistically significant (P < 0.001), and the patient satisfaction was higher than that of the conventional treatment group.","[{'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Burn and Plastic Surgery, Fourth Center of Chinese People's Liberation Army General Hospital, 51# Fucheng Road, Haidian District, Beijing, 100048, China.""}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Burn and Plastic Surgery, Fourth Center of Chinese People's Liberation Army General Hospital, 51# Fucheng Road, Haidian District, Beijing, 100048, China.""}, {'ForeName': 'Minghuo', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ""Department of Burn and Plastic Surgery, Fourth Center of Chinese People's Liberation Army General Hospital, 51# Fucheng Road, Haidian District, Beijing, 100048, China.""}, {'ForeName': 'Quanwen', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': ""Department of Burn and Plastic Surgery, Fourth Center of Chinese People's Liberation Army General Hospital, 51# Fucheng Road, Haidian District, Beijing, 100048, China.""}, {'ForeName': 'Baoguo', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Department of Burn and Plastic Surgery, Fourth Center of Chinese People's Liberation Army General Hospital, 51# Fucheng Road, Haidian District, Beijing, 100048, China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Burn and Plastic Surgery, Fourth Center of Chinese People's Liberation Army General Hospital, 51# Fucheng Road, Haidian District, Beijing, 100048, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Niu', 'Affiliation': 'Department of Burn Surgery, PLA Army 32122, Zhifu District, Yantai, 264000, Shandong, China.'}, {'ForeName': 'Huifeng', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': ""Department of Burn and Plastic Surgery, Fourth Center of Chinese People's Liberation Army General Hospital, 51# Fucheng Road, Haidian District, Beijing, 100048, China. song_huifeng1533@126.com.""}]",Lasers in medical science,['10.1007/s10103-020-03178-w']
2359,33159336,Efficacy of a self-help parenting intervention for parents of children with Attention Deficit Hyperactivity Disorder in adjunct to usual treatment - Small Scale Randomised Controlled Trial.,"BACKGROUND
Multimodal intervention incorporating psychosocial intervention and medication is recommended for school aged children with Attention-Deficit/Hyperactivity Disorder (ADHD). This randomised controlled trial (RCT) investigates the adjunctive benefit of the self-help version of the New Forest Parenting Programme (NFPP-SH) when offered in addition to treatment as usual (TAU) compared to TAU alone.
METHOD
Fifty-two children, receiving medication for ADHD as part of their usual care, were randomised to receive NFPP-SH+TAU or TAU alone.
RESULTS
When used in adjunct to TAU, NFPP-SH may have beneficial effects for parenting efficacy (F=6.28, p=0.02), child social performance in school and negative comments made by parents during a recorded speech sample. However, the self-help intervention did not have any additional effect on child behaviour.
CONCLUSIONS
This study provides further support for self-help interventions as potentially low intensity, and cost-effective alternatives to therapist-led parenting interventions. The findings require replication in larger samples before any firm conclusions about adjunctive efficacy of NFPP-SH can be drawn but underline the potential for self-help within routine treatment. ClinicalTrials.gov Identifier: NCT02174952.",2020,"When used in adjunct to TAU, NFPP-SH may have beneficial effects for parenting efficacy (F=6.28, p=0.02), child social performance in school and negative comments made by parents during a recorded speech sample.","['parents of children with Attention Deficit Hyperactivity Disorder', 'school aged children with Attention-Deficit/Hyperactivity Disorder (ADHD', 'Fifty-two children, receiving medication for ADHD as part of their usual care']","['New Forest Parenting Programme (NFPP-SH', 'NFPP-SH+TAU or TAU alone', 'TAU, NFPP-SH', 'self-help parenting intervention', 'Multimodal intervention incorporating psychosocial intervention and medication', 'NFPP-SH']",['child social performance'],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}]",52.0,0.0879108,"When used in adjunct to TAU, NFPP-SH may have beneficial effects for parenting efficacy (F=6.28, p=0.02), child social performance in school and negative comments made by parents during a recorded speech sample.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Daley', 'Affiliation': 'Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham;, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Tarver', 'Affiliation': 'School of Life and Health Sciences, Aston University, UK.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Sayal', 'Affiliation': 'Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham;, UK.'}]","Child: care, health and development",['10.1111/cch.12825']
2360,33159348,"Comment on ""Preoperative Intravenous Iron Therapy and Survival after Colorectal Cancer Surgery: Long Term Results from the IVICA Randomised Controlled Trial"".","We read with interest the article by Dickson et al. reporting long term follow up of the IVICA trial, comparing parenteral iron to oral iron to correct preoperative anaemia in patients undergoing surgery for colorectal cancer (CRC) [1]. The original randomised controlled trial in 116 patients found no significant difference in postoperative blood transfusion requirement between the two methods of iron replacement in anaemic patients undergoing surgery for stage I-III disease [2].",2020,The original randomised controlled trial in 116 patients found no significant difference in postoperative blood transfusion requirement between the two methods of iron replacement in anaemic patients undergoing surgery for stage I-III disease [2].,"['patients undergoing surgery for colorectal cancer (CRC) [1', 'Colorectal Cancer Surgery', '116 patients', 'anaemic patients undergoing surgery for stage I-III disease [2']",['parenteral iron to oral iron'],['postoperative blood transfusion requirement'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0444624', 'cui_str': 'Iron-containing product in parenteral dose form'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",116.0,0.246042,The original randomised controlled trial in 116 patients found no significant difference in postoperative blood transfusion requirement between the two methods of iron replacement in anaemic patients undergoing surgery for stage I-III disease [2].,"[{'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'McSorley', 'Affiliation': 'Academic Unit of Surgery, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Steele', 'Affiliation': 'Academic Unit of Surgery, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Anderson', 'Affiliation': 'Dept of Coloproctology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'McKinlay', 'Affiliation': 'Dept of Anaesthetics and Perioperative Care, Glasgow Royal Infirmary, Glasgow, UK.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15428']
2361,33159373,"PTSD Coach Online-Arabic: A Randomized Controlled Pilot Trial to Examine Feasibility, Acceptability, and Preliminary Effectiveness.","The Egyptian Revolution of 2011 resulted in high-level exposure to sociopolitical violence, placing a large burden on the mental health care system that cannot be effectively met given the small number of available providers in Egypt. We conducted a nonblinded, randomized controlled pilot trial of an online, self-directed tool for managing posttraumatic stress symptoms (PTSS). The study aimed to evaluate the feasibility, acceptability, and preliminary effectiveness of the PTSD Coach Online-Arabic. Trauma-exposed Egyptian adults with clinically significant PTSS (N = 87; intervention group: n = 41) completed assessments at baseline, weekly over the treatment period, posttest, and 3-month follow-up. Of participants who completed weekly surveys, 88.9% used the program; 22.0% of participants reported regular, weekly use. Most tools received good likeability and perceived benefit scores, but lower perceived benefit scores on three tools suggest that some content may require additional adaptation. Intent-to-treat analyses using multilevel modeling with multiple imputation to account for missing data were conducted. Effect sizes for PTSS were below the cutoff for small effects at posttest, d = -0.14, but demonstrated a small positive effect at 3-months, d = -0.25. There was a small positive effect of treatment on anxiety at posttest, d = -0.37, and a medium effect at 3-month follow-up, d = -0.49. Treatment effects for depressed mood were below the cutoff for small effects at posttest and 3-months, ds = -0.14 and -0.18. These findings suggest that the PTSD Coach Online-Arabic may be a promising supplemental resource for support in this setting.",2020,"There was a small positive effect of treatment on anxiety at posttest,",['Trauma-exposed Egyptian adults with clinically significant PTSS (N = 87; intervention group: n = 41'],['PTSD Coach Online-Arabic'],"['feasibility, acceptability', 'anxiety']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0013717', 'cui_str': 'Egyptian language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0790422,"There was a small positive effect of treatment on anxiety at posttest,","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Miller-Graff', 'Affiliation': 'Department of Psychology, Kroc Institute for International Peace Studies, University of Notre Dame, Notre Dame, Indiana, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ellis', 'Affiliation': 'Department of Psychology, The American University in Cairo, New Cairo, Egypt.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Hosny', 'Affiliation': 'Department of Psychology, The American University in Cairo, New Cairo, Egypt.'}]",Journal of traumatic stress,['10.1002/jts.22621']
2362,33159536,Air vs contrast pyelogram for initial puncture access in percutaneous nephrolithotomy: a randomized controlled trial.,"Percutaneous nephrolithotomy (PCNL) is a standard procedure for large renal stones. Contrast (traditionally) as well as air is being used to delineate pelvi-calyceal system (PCS) to perform initial puncture. Contrast, when used has certain disadvantages including poor differentiation of anterior and posterior calyces. In this interim analysis of 122 patients of a prospective study subjects were stratified in two groups: in group 1, contrast was used while in group 2, air was used to delineate PCS. Out of 122,103 patients underwent puncture by contrast or air exclusively while 19 patients required mix of contrast and air (14 patients failed puncture using contrast while 5 using air). Mean dosage of radiation exposure (8.43 vs. 14.26 mGy), duration of radiation exposure (0.66 vs. 1.02 min), access time (3.72 vs. 5.84 min), were less in group 2 as compared to group 1. 84.5% of patients underwent puncture in single attempt in group 2 as compared to 56.25% in group 1. Five patients had post-operative fever and one had trans-pleural tract dilation. Complete stone clearance was seen in 94.8% of patients using air to only 75% of patients using contrast. Conclusion: Air pyelogram is a feasible, safe, cost effective and efficient access alternative to contrast pyelogram and in difficult situation a mixture of both is better than using one.",2020,"Air pyelogram is a feasible, safe, cost effective and efficient access alternative to contrast pyelogram and in difficult situation a mixture of both is better than using one.","['122,103 patients underwent', '122 patients of a prospective study subjects', 'percutaneous nephrolithotomy']","['Air vs contrast pyelogram', 'puncture by contrast or air exclusively while 19 patients required mix of contrast and air (14 patients failed puncture using contrast while 5 using air', 'Percutaneous nephrolithotomy (PCNL']","['duration of radiation exposure', 'trans-pleural tract dilation', 'access time', 'Mean dosage of radiation exposure', 'Complete stone clearance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0203108', 'cui_str': 'Intravenous pyelogram'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2959488', 'cui_str': 'Dosage of radiation exposure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",122103.0,0.0175719,"Air pyelogram is a feasible, safe, cost effective and efficient access alternative to contrast pyelogram and in difficult situation a mixture of both is better than using one.","[{'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Department of Urology, All India Institute of Medical Sciences, Jodhpur, India.'}, {'ForeName': 'Gautam Ram', 'Initials': 'GR', 'LastName': 'Choudhary', 'Affiliation': 'Department of Urology, All India Institute of Medical Sciences, Jodhpur, India. gautamoshu@gmail.com.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Pandey', 'Affiliation': 'Department of Urology, All India Institute of Medical Sciences, Jodhpur, India.'}, {'ForeName': 'Vijay Kumar Sarma', 'Initials': 'VKS', 'LastName': 'Madduri', 'Affiliation': 'Department of Urology, All India Institute of Medical Sciences, Jodhpur, India.'}, {'ForeName': 'Mahendra', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Department of Urology, All India Institute of Medical Sciences, Jodhpur, India.'}, {'ForeName': 'Likhiteswer', 'Initials': 'L', 'LastName': 'Pallagani', 'Affiliation': 'Department of Urology, All India Institute of Medical Sciences, Jodhpur, India.'}]",Urolithiasis,['10.1007/s00240-020-01222-6']
2363,33159526,Ticagrelor Added to Aspirin in Acute Ischemic Stroke or Transient Ischemic Attack in Prevention of Disabling Stroke: A Randomized Clinical Trial.,"Importance
Reduction of subsequent disabling stroke is the main goal of preventive treatment in the acute setting after transient ischemic attack (TIA) or minor ischemic stroke.
Objective
To evaluate the superiority of ticagrelor added to aspirin in preventing disabling stroke and to understand the factors associated with recurrent disabling stroke.
Design, Setting, and Participants
The Acute Stroke or Transient Ischemic Attack Treated With Ticagrelor and Aspirin for Prevention of Stroke and Death (THALES) was a randomized clinical trial conducted between January 22, 2018, and December 13, 2019, with a 30-day follow-up, at 414 hospitals in 28 countries. The trial included 11 016 patients with a noncardioembolic, nonsevere ischemic stroke or high-risk TIA, including 10 803 with modified Rankin Scale score (mRS) recorded at 30 days.
Interventions
Ticagrelor (180-mg loading dose on day 1 followed by 90 mg twice daily for days 2-30) or placebo within 24 hours of symptom onset. All patients received aspirin, 300 to 325 mg on day 1 followed by 75 to 100 mg daily for days 2 to 30.
Main Outcomes and Measures
Time to the occurrence of disabling stroke (progression of index event or new stroke) or death within 30 days, as measured by mRS at day 30. Disabling stroke was defined by mRS greater than 1.
Results
Among participants with 30-day mRS greater than 1, mean age was 68.1 years, 1098 were female (42.6%), and 2670 had an ischemic stroke (95.8%) as a qualifying event. Among 11 016 patients, a primary end point with mRS greater than 1 at 30 days occurred in 221 of 5511 patients (4.0%) randomized to ticagrelor and in 260 of 5478 patients (4.7%) randomized to placebo (hazard ratio [HR], 0.83; 95% CI, 0.69-0.99, P = .04). A primary end point with mRS 0 or 1 at 30 days occurred in 70 of 5511 patients (1.3%) and 87 of 5478 patients (1.6%) (HR, 0.79; 95% CI, 0.57-1.08; P = .14). The ordinal analysis of mRS in patients with recurrent stroke showed a shift of the disability burden following a recurrent ischemic stroke in favor of ticagrelor (odds ratio, 0.77; 95% CI, 0.65-0.91; P = .002). Factors associated with disability were baseline National Institutes of Health Stroke Scale score 4 to 5, ipsilateral stenosis of at least 30%, Asian race/ethnicity, older age, and higher systolic blood pressure, while treatment with ticagrelor was associated with less disability.
Conclusions and Relevance
In patients with TIA and minor ischemic stroke, ticagrelor added to aspirin was superior to aspirin alone in preventing disabling stroke or death at 30 days and reduced the total burden of disability owing to ischemic stroke recurrence.
Trial Registration
ClinicalTrials.gov Identifier: NCT03354429.",2020,"In patients with TIA and minor ischemic stroke, ticagrelor added to aspirin was superior to aspirin alone in preventing disabling stroke or death at 30 days and reduced the total burden of disability owing to ischemic stroke recurrence.
","['Disabling Stroke', ' mean age was 68.1 years, 1098 were female (42.6%), and 2670 had an ischemic stroke (95.8%) as a qualifying event', 'January 22, 2018, and December 13, 2019, with a 30-day follow-up, at 414 hospitals in 28 countries', '016 patients with a noncardioembolic, nonsevere ischemic stroke or high-risk TIA, including 10\u202f803 with modified Rankin Scale score (mRS) recorded at 30 days', 'participants with 30-day mRS greater than 1']","['Ticagrelor', 'Ticagrelor and Aspirin', 'Aspirin', 'placebo', 'ticagrelor', 'aspirin']","['Acute Stroke or Transient Ischemic Attack', 'total burden of disability', 'disabling stroke', 'systolic blood pressure', 'disabling stroke or death', 'Disabling stroke', 'Measures\n\n\nTime to the occurrence of disabling stroke (progression of index event or new stroke) or death within 30 days, as measured by mRS']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",11016.0,0.293284,"In patients with TIA and minor ischemic stroke, ticagrelor added to aspirin was superior to aspirin alone in preventing disabling stroke or death at 30 days and reduced the total burden of disability owing to ischemic stroke recurrence.
","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': 'Department of Neurology and Stroke Center, Bichat University Hospital, University of Paris, Paris, France.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Denison', 'Affiliation': 'AstraZeneca, Biopharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Evans', 'Affiliation': 'Biostatistics Center, The George Washington University, Washington, DC.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Himmelmann', 'Affiliation': 'AstraZeneca, Biopharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knutsson', 'Affiliation': 'AstraZeneca, Biopharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ladenvall', 'Affiliation': 'AstraZeneca, Biopharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': ""Stroke Unit, Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Tiantan Hospital, Beijing, China.'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Dean's Office, Dell Medical School, The University of Texas at Austin.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2020.4396']
2364,33159574,Glycemic control improvement in individuals with type 2 diabetes with vitamin K 2 supplementation: a randomized controlled trial.,"PURPOSE
This study aimed to investigate the effects of vitamin K 2 supplementation in the form of menaquinone-7 (MK-7) on glucose, insulin, and lipid metabolism in patients with type 2 diabetes mellitus (T2DM).
METHODS
In this double-blinded, placebo-controlled, randomized trial, 68 insulin-independent people with diabetes received either 180 µg MK-7 twice a day or placebo for 12 weeks. We assessed fasting plasma glucose (FPG) and insulin concentrations (primary outcomes), glycated hemoglobin (HbA1c), insulin sensitivity indices, and lipid profiles (secondary outcomes) at baseline and end of the trial.
RESULTS
At the end of the trial, FPG (effect size (ES) = - 0.68; p-adjusted = 0.031) and HbA1c (ES = - 0.36; p-adjusted = 0.004) were significantly lower in the vitamin K 2 group compared with the placebo at the end of the trial. The number of participants achieved the target levels of glycemic control based on FPG, and HbA1c concentrations were significantly higher in the vitamin K 2 group compared to the placebo group. Insulin concentrations (ES = - 0.29; p = 0.019) and homeostatic model assessment for insulin resistance (HOMA-IR) significantly decreased in the vitamin K 2 group (ES = - 0.29; p = 0.019) compared to baseline, but their values were not significantly different compared to the placebo group at the end of the trial. No significant variation was observed in lipid profiles.
CONCLUSION
Daily intake of 360 µg Vitamin K 2 in the form of MK-7 for 12-weeks reduces FPG and HbA1c in patients with T2DM but does not have a lipid-lowering effect.",2020,"Insulin concentrations (ES = - 0.29; p = 0.019) and homeostatic model assessment for insulin resistance (HOMA-IR) significantly decreased in the vitamin K 2 group (ES = - 0.29; p = 0.019) compared to baseline, but their values were not significantly different compared to the placebo group at the end of the trial.","['patients with T2DM', 'patients with type 2 diabetes mellitus (T2DM', 'individuals with type 2 diabetes with vitamin K 2 supplementation', '68 insulin-independent people with diabetes']","['180\xa0µg MK-7 twice a day or placebo', 'placebo', 'vitamin K 2 supplementation']","['Glycemic control improvement', 'target levels of glycemic control based on FPG, and HbA1c concentrations', 'lipid profiles', 'Insulin concentrations', 'fasting plasma glucose (FPG) and insulin concentrations (primary outcomes), glycated hemoglobin (HbA1c), insulin sensitivity indices, and lipid profiles (secondary outcomes', 'homeostatic model assessment for insulin resistance (HOMA-IR', 'glucose, insulin, and lipid metabolism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086605', 'cui_str': 'Vitamin K 2'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1299583', 'cui_str': 'Independent'}]","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086605', 'cui_str': 'Vitamin K 2'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",68.0,0.582181,"Insulin concentrations (ES = - 0.29; p = 0.019) and homeostatic model assessment for insulin resistance (HOMA-IR) significantly decreased in the vitamin K 2 group (ES = - 0.29; p = 0.019) compared to baseline, but their values were not significantly different compared to the placebo group at the end of the trial.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rahimi Sakak', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, No. 46, Arghavan-e-gharbi St., Farahzadi Blvd., Shahrak-e-qods, P.O.Box 19395-4741, Tehran, Iran.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Moslehi', 'Affiliation': 'Nutrition and Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, No. 24, Shahid Arabi St, Yemen Blvd, Chamran Exp, Tehran, Iran. moslehinazanin@yahoo.com.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Niroomand', 'Affiliation': 'Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Mirmiran', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, No. 46, Arghavan-e-gharbi St., Farahzadi Blvd., Shahrak-e-qods, P.O.Box 19395-4741, Tehran, Iran. mirmiran@endocrine.ac.ir.'}]",European journal of nutrition,['10.1007/s00394-020-02419-6']
2365,33159620,Effect of whole-body vibration on freezing and flexibility in Parkinson's disease-a pilot study.,"BACKGROUND
Parkinson's disease is the second most common neurodegenerative disease. Symptoms are treated by medication, physio-, exercise, and occupational therapy. Alternative methods have been used in exercise therapy for a few years now. The effect of whole-body vibration as an alternative training method has been investigated for several symptoms in Parkinson's disease. Since freezing and flexibility have not yet been investigated, the aim of this study was to evaluate the efficacy of different frequencies of application for these two symptoms.
METHODS
Patients were randomly assigned to a frequency (6, 12, or 18 Hz) or the control group. Before and after the treatment of 5 × 60 s with a rest of 60 s each, the Sit and Reach test (flexibility) and the 360° turn test (freezing) were performed.
RESULTS
Only the Sit and Reach test showed a significant improvement at 18 Hz (improvement from - 5.75 to - 1.89 cm, F(3,30) = 5.98**). At 360° turn, no significant differences were found. Weak to high effect sizes (standardized mean differences) were determined for the different frequencies, both for the Sit and Reach (from .01 to .64) and for the 360° turn (from - .72 to - 1.25). The highest effect size is observed for 18 Hz and the lowest for 6 Hz.
CONCLUSIONS
Higher frequencies seem to be more effective than lower ones. Freezing, age, and gender also seem to play a role. Therefore, this should be investigated in further studies.",2020,"Weak to high effect sizes (standardized mean differences) were determined for the different frequencies, both for the Sit and Reach (from .01 to .64) and for the 360° turn (from - .72 to - 1.25).","['Patients were randomly assigned to a frequency (6, 12, or 18 Hz) or the control group']",['whole-body vibration'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}]",[],,0.0292794,"Weak to high effect sizes (standardized mean differences) were determined for the different frequencies, both for the Sit and Reach (from .01 to .64) and for the 360° turn (from - .72 to - 1.25).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Dincher', 'Affiliation': 'Sportwissenschaftliches Institut der Universität des Saarlandes, Saarbrücken, Germany. andrea.dincher@uni-saarland.de.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Becker', 'Affiliation': 'Sportwissenschaftliches Institut der Universität des Saarlandes, Saarbrücken, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Wydra', 'Affiliation': 'Sportwissenschaftliches Institut der Universität des Saarlandes, Saarbrücken, Germany.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-020-04884-7']
2366,33159632,"The Pediatric Autism Spectrum Therapy Observation System: Development, Psychometric Properties, and Sensitivity to Treatment.","An observational coding system was developed to track clinical change in children with autism spectrum disorder (ASD) during psychotherapy. The Pediatric Autism Spectrum Therapy Observation System (PASTOS) consists of 23 items divided into 5 subscales and is used to rate child behaviors in individual psychotherapy sessions. Manual-based cognitive behavioral therapy session transcripts of 22 children diagnosed with ASD (IQ > 70) and a concurrent anxiety disorder (M = 9.41 years, SD = 1.56 years) enrolled in a randomized, controlled trial were coded. Results suggested that the PASTOS exhibited promising interrater reliability, internal consistency, convergent validity at post-treatment, and treatment sensitivity. The PASTOS may be a useful tool for studying process and outcome in psychotherapy research on children with ASD.",2020,"Manual-based cognitive behavioral therapy session transcripts of 22 children diagnosed with ASD (IQ > 70) and a concurrent anxiety disorder (M = 9.41 years, SD = 1.56 years) enrolled in a randomized, controlled trial were coded.","['children with autism spectrum disorder (ASD) during psychotherapy', '22 children diagnosed with ASD (IQ\u2009>\u200970) and a concurrent anxiety disorder (M\u2009=\u20099.41\xa0years, SD\u2009=\u20091.56\xa0years) enrolled', 'children with ASD']",['Manual-based cognitive behavioral therapy session transcripts'],"['interrater reliability, internal consistency, convergent validity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517507', 'cui_str': '1.56'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",22.0,0.0298622,"Manual-based cognitive behavioral therapy session transcripts of 22 children diagnosed with ASD (IQ > 70) and a concurrent anxiety disorder (M = 9.41 years, SD = 1.56 years) enrolled in a randomized, controlled trial were coded.","[{'ForeName': 'Marilyn V', 'Initials': 'MV', 'LastName': 'Van Dyke', 'Affiliation': 'Graduate School of Education and Information Studies, Division of Human Development and Psychology, University of California, Los Angeles, 405 Hilgard Ave., Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Maria V Cornejo', 'Initials': 'MVC', 'LastName': 'Guevara', 'Affiliation': 'Graduate School of Education and Information Studies, Division of Human Development and Psychology, University of California, Los Angeles, 405 Hilgard Ave., Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'Wood', 'Affiliation': 'Graduate School of Education and Information Studies, Division of Human Development and Psychology, University of California, Los Angeles, 405 Hilgard Ave., Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Bryce D', 'Initials': 'BD', 'LastName': 'McLeod', 'Affiliation': 'Psychology Department, Virginia Commonwealth University, Richmond, USA.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Wood', 'Affiliation': 'Graduate School of Education and Information Studies, Division of Human Development and Psychology, University of California, Los Angeles, 405 Hilgard Ave., Los Angeles, CA, 90095, USA. jeffwood@ucla.edu.'}]",Child psychiatry and human development,['10.1007/s10578-020-01068-4']
2367,33156688,Comparison of the Effect of Breast Milk and Sodium Bicarbonate Solution for Oral Care in Infants with Tracheal Intubation After Cardiothoracic Surgery.,"Background: This study aimed to explore the effect of breast milk and sodium bicarbonate solution used in oral care of infants with tracheal intubation after cardiothoracic surgery. Methods: A randomized clinical controlled trial was conducted in a provincial hospital in China. Fifty infantile patients were randomly divided into two groups: the patients in the study group ( n = 25) used breast milk for oral care and the patients in the control group ( n = 25) used sodium bicarbonate solution for oral care. The relevant clinical data were recorded, including the mechanical ventilation duration, length of intensive care unit (ICU) stay, length of hospital stay, and complications. Results: The length of ICU stay, length of hospital stay, and duration of mechanical ventilation were shorter in the study group, but the difference was not statistically significant ( p > 0.05). However, the incidence of thrush and ventilator-associated pulmonary infection in the study group was significantly lower than that in the control group ( p < 0.05). Conclusion: The use of breast milk for oral care has a positive effect on the prevention of thrush and ventilator-associated pulmonary infection in infants with tracheal intubation after cardiothoracic surgery.",2020,"The length of ICU stay, length of hospital stay, and duration of mechanical ventilation were shorter in the study group, but the difference was not statistically significant ( p > 0.05).","['Fifty infantile patients', 'infants with tracheal intubation after cardiothoracic surgery', 'Infants with Tracheal Intubation', 'provincial hospital in China']","['Breast Milk and Sodium Bicarbonate Solution', 'breast milk for oral care and the patients in the control group ( n \u2009=\u200925) used sodium bicarbonate solution for oral care', 'breast milk and sodium bicarbonate solution']","['mechanical ventilation duration, length of intensive care unit (ICU) stay, length of hospital stay, and complications', 'length of ICU stay, length of hospital stay, and duration of mechanical ventilation', 'incidence of thrush and ventilator-associated pulmonary infection']","[{'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C1274037', 'cui_str': 'Cardiothoracic surgery'}, {'cui': 'C3661820', 'cui_str': 'Provincial hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0006840', 'cui_str': 'Candidiasis'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}]",50.0,0.0395689,"The length of ICU stay, length of hospital stay, and duration of mechanical ventilation were shorter in the study group, but the difference was not statistically significant ( p > 0.05).","[{'ForeName': 'Xian-Rong', 'Initials': 'XR', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Wang-Sheng', 'Initials': 'WS', 'LastName': 'Dai', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Zeng-Chun', 'Initials': 'ZC', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0239']
2368,33156692,"Foot Core Training to Prevent Running-Related Injuries: A Survival Analysis of a Single-Blind, Randomized Controlled Trial.","BACKGROUND
Running-related injuries (RRIs) are a pervasive menace that can interrupt or end the participation of recreational runners in this healthy physical activity. To date, no satisfactory treatment has been developed to prevent RRIs.
PURPOSE
To investigate the efficacy of a novel foot core strengthening protocol based on a ground-up approach to reduce the incidence of RRIs in recreational long-distance runners over the course of a 1-year follow-up.
STUDY DESIGN
Randomized controlled trial; Level of evidence, 1.
METHODS
The participants, 118 runners, were assessed at baseline and randomly allocated to either an intervention group (n = 57) or a control group (n = 61). The intervention group received an 8-week training course focused on the foot-ankle muscles, followed by remotely supervised training thereafter. Assessments consisted of 3 separate biomechanical evaluations of foot strength and foot posture and a weekly report on each participant's running distance, pace, and injury incidence over 12 months.
RESULTS
The control group participants were 2.42 times (95% CI, 1.98-3.62) more likely to experience an RRI within the 12-month study period than participants in the intervention group ( P = .035). Time to injury was significantly correlated with Foot Posture Index ( P = .031; r = 0.41) and foot strength gain ( P = .044; r = 0.45) scores. This foot exercise program showed evidence of effective RRI risk reduction in recreational runners at 4 to 8 months of training.
CONCLUSION
Recreational runners randomized to the new foot core strengthening protocol had a 2.42-fold lower rate of RRIs compared with the control group. Further studies are recommended to better understand the underlying biomechanical mechanisms of injury, types of injuries, and subgroups of runners who might benefit maximally.
REGISTRATION
NCT02306148 (ClinicalTrials.gov identifier).",2020,"This foot exercise program showed evidence of effective RRI risk reduction in recreational runners at 4 to 8 months of training.
","['recreational runners', 'Running-Related Injuries', 'The participants, 118 runners']","['novel foot core strengthening protocol', 'Foot Core Training', '8-week training course focused on the foot-ankle muscles, followed by remotely supervised training thereafter']","['foot strength gain', 'effective RRI risk reduction', 'Foot Posture Index', 'rate of RRIs']","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",,0.161311,"This foot exercise program showed evidence of effective RRI risk reduction in recreational runners at 4 to 8 months of training.
","[{'ForeName': 'Ulisses T', 'Initials': 'UT', 'LastName': 'Taddei', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alessandra B', 'Initials': 'AB', 'LastName': 'Matias', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Duarte', 'Affiliation': 'Biomedical Engineering, Federal University of ABC, São Paulo, Brazil.'}, {'ForeName': 'Isabel C N', 'Initials': 'ICN', 'LastName': 'Sacco', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of São Paulo, São Paulo, Brazil.'}]",The American journal of sports medicine,['10.1177/0363546520969205']
2369,33156725,Master and Apprentice or a Slave to Technology? A Randomized Controlled Trial of Minimal Access Surgery Simulation-Based Training Techniques.,"Introduction: This study set out to assess the efficacy of three different approaches to simulation-based minimal access surgery (MAS) training using a three-dimensional printed neonatal thoracoscopic simulator and a virtual simulator. Materials and Methods: Randomized controlled trial of medical students ( N = 32), as novices to MAS. The participants performed two construct validated tasks on a thoracoscopic simulator and were then randomly allocated into four intervention groups: (1) three consultant-led sessions on a thoracoscopic simulator; (2) three self-directed learning sessions on the same simulator; (3) self-directed ""virtual training"" on the ""SimuSurg"" application; and (4) control. Postintervention participants repeated both tasks. Videos of all task attempts were de-identified and marked by a blinded consultant pediatric surgeon. Results: There were no statistically significant differences in baseline objective structured assessment of technical skills (OSATS) scores or demographics in any group. For the ""ring transfer"" task, Groups 1 and 2 showed significant improvement after intervention, with no significant change in Groups 3 or 4. There was no significant difference between Groups 1 or 2 in postintervention scores. For the ""needle pass"" task, no group demonstrated a statistically significant improvement after intervention. Conclusion: Practice on a physical simulator either consultant-led or self-directed led to improved scores for MAS novices compared with a virtual simulator or no intervention for a simple ""ring transfer"" task. This suggests that time on the physical simulator was the most important factor and implies that trainees could usefully practice simple tasks at their convenience rather than require consultant supervision. This improvement is not seen in more challenging tasks such as the ""needle pass.""",2020,"Conclusion: Practice on a physical simulator either consultant-led or self-directed led to improved scores for MAS novices compared with a virtual simulator or no intervention for a simple ""ring transfer"" task.","['medical students ( N \u2009=\u200932), as novices to MAS']","['Minimal Access Surgery Simulation-Based Training Techniques', 'consultant-led sessions on a thoracoscopic simulator; (2) three self-directed learning sessions on the same simulator; (3) self-directed ""virtual training"" on the ""SimuSurg"" application; and (4) control', 'simulation-based minimal access surgery (MAS) training']",['technical skills (OSATS) scores or demographics'],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0080236', 'cui_str': 'Training Technics'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",,0.0467646,"Conclusion: Practice on a physical simulator either consultant-led or self-directed led to improved scores for MAS novices compared with a virtual simulator or no intervention for a simple ""ring transfer"" task.","[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'MacArthur-Beadle', 'Affiliation': 'Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'David V K', 'Initials': 'DVK', 'LastName': 'Nair', 'Affiliation': 'University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Cook', 'Affiliation': 'Symulus.net.'}, {'ForeName': 'Ma', 'Initials': 'M', 'LastName': 'Yi', 'Affiliation': 'Biostatistics, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Symulus.net.'}, {'ForeName': 'Spencer W', 'Initials': 'SW', 'LastName': 'Beasley', 'Affiliation': 'University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Wells', 'Affiliation': 'University of Otago, Christchurch, New Zealand.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2020.0637']
2370,33156757,The effect of TB treatment on health-related quality of life for people with advanced HIV.,"BACKGROUND: Study A5274 was an open-label trial of people with HIV (PLHIV) with CD4 cell count <50 cells/µL who were randomized to empirical TB treatment vs. isoniazid preventive therapy (IPT) in addition to antiretroviral therapy (ART). We evaluated health-related quality of life (HRQoL) by study arm, changes over time, and association with sociodemographic and clinical factors. METHODS: Participants aged >13 years were enrolled from outpatient clinics in 10 countries. HRQoL was assessed at Weeks 0, 8, 24 and 96 with questions about daily activity, hospital or emergency room visits, and general health status. We used logistic regression to examine HRQoL by arm and association with sociodemographic and clinical factors. RESULTS: Among 850 participants (424 empiric arm, 426 IPT arm), HRQoL improved over time with no difference between arms. At baseline and Week 24, participants with WHO Stage 3 or 4 events, or those who had Grade 3 or 4 signs/symptoms, were significantly more likely to report poor HRQoL using the composite of four HRQoL measures. CONCLUSION: HRQoL improved substantially in both arms during the study period. These findings show that ART, TB screening, and IPT can not only reduce mortality, but also improve HRQoL in PLHIV with advanced disease.",2020,"HRQoL was assessed at Weeks 0, 8, 24 and 96 with questions about daily activity, hospital or emergency room visits, and general health status.","['850 participants (424 empiric arm, 426 IPT arm', 'people with advanced HIV', 'people with HIV (PLHIV) with CD4 cell count <50 cells/µL', 'Participants aged >13 years were enrolled from outpatient clinics in 10 countries']","['HRQoL', 'isoniazid preventive therapy (IPT) in addition to antiretroviral therapy (ART', 'TB']","['health-related quality of life', 'health-related quality of life (HRQoL', 'HRQoL']","[{'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",850.0,0.18047,"HRQoL was assessed at Weeks 0, 8, 24 and 96 with questions about daily activity, hospital or emergency room visits, and general health status.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Opollo', 'Affiliation': 'Kenya Medical Research Institute, HIV-Research Branch, Kisumu, Kenya.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lando', 'Affiliation': 'Kenya Medical Research Institute, HIV-Research Branch, Kisumu, Kenya.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Miyahara', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'Torres', 'Affiliation': 'Instituto Nacional de Infectologia Evandro Chagas (INI-FIOCRUZ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC, USA, University of North Carolina Project, Lilongwe, Malawi.'}, {'ForeName': 'G P', 'Initials': 'GP', 'LastName': 'Bisson', 'Affiliation': 'Perlman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kumwenda', 'Affiliation': 'Johns Hopkins Project, Blantyre, Malawi.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'Johns Hopkins Project, Blantyre, Malawi.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Katende', 'Affiliation': 'Joint Clinical Research Centre Clinical Research Site, Kampala, Uganda.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Suryavanshi', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College Clinical Trials Unit, Pune, India.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Beulah', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education, Chennai Antiviral Research and Treatment Clinical Research Site, Chennai, India.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Shah', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}]",The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease,['10.5588/ijtld.19.0716']
2371,33159633,Cumulative incidence of cardiovascular events under tamoxifen and letrozole alone and in sequence: a report from the BIG 1-98 trial.,"BACKGROUND
Compared to tamoxifen, adjuvant treatment with aromatase inhibitors improves disease outcomes of postmenopausal women with hormone receptor-positive early breast cancer. In the international, randomized, double-blind BIG 1-98 trial, 8010 women were randomized to receive tamoxifen, letrozole, or sequential use of the agents for 5 years. With a focus on switching between agents, we investigated cardiovascular events over the entire 5-year treatment period.
METHODS
Of the 6182 patients enrolled, 6144 started trial treatment and were included in this analysis. Adverse events occurring during study treatment until 30 days after cessation were considered. Eight cardiovascular event types were defined. Cumulative incidence of events were estimated using the Kaplan-Meier method, without consideration for competing events. Multivariable Cox models estimated hazard ratios (HR) with 95% confidence intervals (CI) for pairwise comparisons of treatment arms.
RESULTS
While on study treatment, 6.5% of patients (n = 397) had any cardiac events reported; for 2.4%, the event was grades 3-5, of which 11 (0.2%) were grade 5. Letrozole monotherapy was associated with higher risk of grade 1-5 ischemic heart disease (HR = 1.81; 95% CI, 1.06-3.08) compared with tamoxifen monotherapy. Patients assigned sequential tamoxifen →letrozole (HR = 1.59; 95% CI, 0.92-2.74) or sequential letrozole → tamoxifen (HR = 1.20; 95% CI, 0.68-2.14) showed a lesser degree of risk elevation. Patients assigned to tamoxifen-containing regimens had significantly higher risk of grade 1-5 thromboembolic events (tamoxifen monotherapy HR = 2.10; 95% CI, 1.42-3.12; tamoxifen → letrozole HR = 1.96; 95% CI, 1.32-2.92; letrozole → tamoxifen HR = 1.56; 95% CI 1.03-2.35) as compared with patients assigned letrozole alone.
CONCLUSION
When initiating or switching between adjuvant endocrine treatments in postmenopausal patients, age and medical history, with special attention to prior cardiovascular events, should be balanced with expected benefit of the treatment.",2020,"Letrozole monotherapy was associated with higher risk of grade 1-5 ischemic heart disease (HR = 1.81; 95% CI, 1.06-3.08) compared with tamoxifen monotherapy.","['8010 women', 'postmenopausal patients, age and medical history, with special attention to prior cardiovascular events', 'Of the 6182 patients enrolled', 'postmenopausal women with hormone receptor-positive early breast cancer']","['tamoxifen and letrozole', 'sequential letrozole → tamoxifen', 'letrozole', 'tamoxifen, letrozole', 'tamoxifen', 'Letrozole monotherapy', 'sequential tamoxifen →letrozole', 'aromatase inhibitors']","['higher risk of grade 1-5 ischemic heart disease', 'Adverse events', 'risk of grade 1-5 thromboembolic events', 'cardiovascular events', 'Cumulative incidence of cardiovascular events', 'degree of risk elevation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",8010.0,0.509276,"Letrozole monotherapy was associated with higher risk of grade 1-5 ischemic heart disease (HR = 1.81; 95% CI, 1.06-3.08) compared with tamoxifen monotherapy.","[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Rabaglio', 'Affiliation': 'International Breast Cancer Study Group (IBCSG) Coordinating Center, Bern, Switzerland. manuela.rabaglio@insel.ch.'}, {'ForeName': 'Zhuoxin', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Division of Biostatistics, IBCSG Statistical Center, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Maibach', 'Affiliation': 'International Breast Cancer Study Group (IBCSG) Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Giobbie-Hurder', 'Affiliation': 'Division of Biostatistics, IBCSG Statistical Center, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Ejlertsen', 'Affiliation': 'Danish Breast Cancer Cooperative Group, Copenhagen, Denmark.'}, {'ForeName': 'Vernon J', 'Initials': 'VJ', 'LastName': 'Harvey', 'Affiliation': 'Breast Cancer Trials (Formerly Known As the Breast Cancer Institute of Australia & Australia and New Zealand Breast Cancer Trials Group, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Gynecologic Oncology and Multidisciplinary Breast Center, University Hospitals UZ-Leuven, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Láng', 'Affiliation': 'Istenhegyi Géndiagnosztika Private Health Center, Oncology Clinic, Budapest, Hungary.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Bonnefoi', 'Affiliation': 'Institut Bergonié Unicancer, Université de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wardley', 'Affiliation': 'NIHR Manchester Clinical Research Facility At The Christie and Division of Cancer Sciences, Manchester Academic Health Science Center, University of Manchester, Manchester, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ruepp', 'Affiliation': 'International Breast Cancer Study Group (IBCSG) Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Castiglione', 'Affiliation': 'International Breast Cancer Study Group (IBCSG) Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Coates', 'Affiliation': 'International Breast Cancer Study Group (IBCSG) Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'Division of Biostatistics, IBCSG Statistical Center, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Goldhirsch', 'Affiliation': 'IBCSG and SAKK, Bern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'International Breast Cancer Study Group (IBCSG) Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Thürlimann', 'Affiliation': 'Breast Center St. Gallen, St. Gallen and SAKK, Kantonsspital, Bern, Switzerland.'}, {'ForeName': 'Meredith M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'Division of Biostatistics, IBCSG Statistical Center, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05981-z']
2372,33159658,"Pharmacokinetics, Safety and Tolerability of Once-Weekly Subcutaneous Semaglutide in Healthy Chinese Subjects: A Double-Blind, Phase 1, Randomized Controlled Trial.","INTRODUCTION
Once-weekly (OW) subcutaneous (s.c.) semaglutide is an injectable glucagon-like peptide-1 (GLP-1) analogue approved for the treatment of type 2 diabetes. This trial was designed to assess the pharmacokinetics, safety and tolerability of OW s.c. semaglutide in healthy Chinese subjects.
METHODS
In this single-centre, randomised, double-blind, placebo-controlled trial, 36 healthy subjects were randomised to OW s.c. semaglutide 0.5 mg (n = 12), 1.0 mg (n = 12), or placebo (n = 12). Treatment (semaglutide or placebo) was blinded for the subjects, investigators and sponsor. The primary endpoint was steady-state semaglutide exposure, defined as the area under the curve over a dosing interval at steady state (AUC 0-168 h,SS ).
RESULTS
In total, 34 subjects completed the trial. The steady-state exposure of semaglutide was higher for subjects treated with 1.0 mg semaglutide (AUC 0-168 h,ss : 7961 nmol h/l and C max,ss : 55.9 nmol/l) compared to 0.5 mg semaglutide (AUC 0-168 h,ss : 4000 nmol h/l and C max,ss : 28.8 nmol/l). The total exposure of semaglutide increased in a dose-proportional manner in healthy Chinese subjects; the treatment ratio (1.0 mg/0.5 mg) [95% confidence interval] for AUC 0-168 h,SS was 1.99 [1.78; 2.23]. Treatment with OW s.c. semaglutide was well tolerated in healthy Chinese subjects. As expected for the GLP-1 receptor agonist class, the most common adverse events were gastrointestinal, and no new safety signals were identified.
CONCLUSION
The pharmacokinetics, safety and tolerability of OW s.c. semaglutide in healthy Chinese subjects were consistent with previous clinical pharmacology trials of OW s.c. semaglutide in other populations. The results suggest that no dose adjustment is necessary for semaglutide in Chinese patients with T2D.
TRIAL REGISTRATION
ClinicalTrials.gov, identifier NCT03288740.",2020,The total exposure of semaglutide increased in a dose-proportional manner in healthy Chinese subjects; the treatment ratio (1.0 mg/0.5 mg),"['Healthy Chinese Subjects', '34 subjects completed the trial', 'healthy Chinese subjects', '36 healthy subjects']","['Treatment (semaglutide or placebo', 'placebo', 'Once-Weekly Subcutaneous Semaglutide', 'semaglutide 0.5']","['steady-state semaglutide exposure, defined as the area under the curve over a dosing interval at steady state (AUC 0-168\xa0h,SS ', 'Pharmacokinetics, Safety and Tolerability', 'total exposure of semaglutide', 'steady-state exposure of semaglutide', 'pharmacokinetics, safety and tolerability of OW', 'pharmacokinetics, safety and tolerability']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}]",36.0,0.221703,The total exposure of semaglutide increased in a dose-proportional manner in healthy Chinese subjects; the treatment ratio (1.0 mg/0.5 mg),"[{'ForeName': 'Aixin', 'Initials': 'A', 'LastName': 'Shi', 'Affiliation': ""Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China. aixins0302@126.com.""}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Xie', 'Affiliation': ""Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Lasse Lykke', 'Initials': 'LL', 'LastName': 'Nielsen', 'Affiliation': 'Novo Nordisk A/S, Bagsværd, Denmark.'}, {'ForeName': 'Trine Vang', 'Initials': 'TV', 'LastName': 'Skjøth', 'Affiliation': 'Novo Nordisk A/S, Bagsværd, Denmark.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ""Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Sine Pfeiffer', 'Initials': 'SP', 'LastName': 'Haugaard', 'Affiliation': 'Novo Nordisk A/S, Bagsværd, Denmark.'}]",Advances in therapy,['10.1007/s12325-020-01548-y']
2373,33159674,"Phase II study of amrubicin plus erlotinib in previously treated, advanced non-small cell lung cancer with wild-type epidermal growth factor receptor (TORG1320).","Background Amrubicin (AMR) is a completely synthetic 9-aminoanthracycline and clinically active against non-small cell lung cancer (NSCLC). We conducted a phase I study of AMR and erlotinib (ERL) combination therapy in previously treated patients with advanced NSCLC and have already reported the safety and effectiveness. Methods We conducted a multi-center, single-arm phase II trial to evaluate the efficacy of AMR and ERL combination therapy in patients with previously treated, advanced NSCLC harboring wild-type EGFR, PS 0-1 and < 75 years of age. Patients were treated at 3-week intervals with AMR plus ERL. The primary endpoint was the PFS, and the secondary endpoints were the response rate (RR), disease control rate (DCR), overall survival (OS) and toxicity. The trough ERL concentration (C trough ) was measured as an exploratory study to analyze the relationship between the efficacy/safety and pharmacokinetics. Results From June 2013 to July 2016, 25 patients were enrolled in this trial. The PFS according to the central test was 3.6 months (95% confidence interval 2.1-5.1). The RR and DCR were 24.0% and 64.0%, respectively. We had no treatment-related deaths in this study. Conclusions The PFS of AMR and ERL combination therapy was superior to that of AMR monotherapy in the historical setting, but the primary endpoint was not met in this trial. In our study, the pharmacokinetic analysis showed that the C trough of ERL was elevated with combination therapy. This combination therapy might be a viable treatment for previously treated NSCLC patients without a driver oncogene mutation. Clinical trial information UMIN 000010582.",2020,"The PFS of AMR and ERL combination therapy was superior to that of AMR monotherapy in the historical setting, but the primary endpoint was not met in this trial.","['Results From June 2013 to July 2016', '25 patients were enrolled in this trial', 'previously treated, advanced non-small cell lung cancer with wild-type epidermal growth factor receptor (TORG1320', 'previously treated NSCLC patients without a driver oncogene mutation', 'previously treated patients with advanced NSCLC', 'patients with previously treated, advanced NSCLC harboring wild-type EGFR, PS 0-1 and\u2009<\u200975\xa0years of age']","['AMR and ERL combination therapy', 'amrubicin plus erlotinib', 'AMR plus ERL', ' Amrubicin (AMR', 'AMR monotherapy', 'AMR and erlotinib (ERL) combination therapy']","['efficacy/safety and pharmacokinetics', 'RR and DCR', 'trough ERL concentration (C trough ', 'PFS', 'response rate (RR), disease control rate (DCR), overall survival (OS) and toxicity']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0029016', 'cui_str': 'Oncogene'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0762659', 'cui_str': 'amrubicin'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",25.0,0.209496,"The PFS of AMR and ERL combination therapy was superior to that of AMR monotherapy in the historical setting, but the primary endpoint was not met in this trial.","[{'ForeName': 'Sakiko', 'Initials': 'S', 'LastName': 'Otani', 'Affiliation': 'Department of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1, Kitasato, Minami-ku, Sagamihara city, Kanagawa, 252-0375, Japan. sakiko.o@kitasato-u.ac.jp.'}, {'ForeName': 'Jiichiro', 'Initials': 'J', 'LastName': 'Sasaki', 'Affiliation': 'Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, 1-15-1, Kitasato, Minami-ku, Sagamihara city, Kanagawa, 252-0375, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Nakahara', 'Affiliation': 'Department of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1, Kitasato, Minami-ku, Sagamihara city, Kanagawa, 252-0375, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Fukui', 'Affiliation': 'Department of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1, Kitasato, Minami-ku, Sagamihara city, Kanagawa, 252-0375, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Igawa', 'Affiliation': 'Department of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1, Kitasato, Minami-ku, Sagamihara city, Kanagawa, 252-0375, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Naoki', 'Affiliation': 'Department of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1, Kitasato, Minami-ku, Sagamihara city, Kanagawa, 252-0375, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Bessho', 'Affiliation': 'Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, 2-1-1, aoe,Kita-ku, Okayama-city, 700-8607, Japan.'}, {'ForeName': 'Shinobu', 'Initials': 'S', 'LastName': 'Hosokawa', 'Affiliation': 'Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, 2-1-1, aoe,Kita-ku, Okayama-city, 700-8607, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Fukamatsu', 'Affiliation': 'Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, 2-1-1, aoe,Kita-ku, Okayama-city, 700-8607, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': ""Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, 56, Okazawa-cho, Hodogaya-ku, Yokohama city, Kanagawa, 240-8555, Japan.""}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kasai', 'Affiliation': 'Division of Thoracic Oncology, Tochigi Cancer Center, 4-9-13, Yonan, Utsunomiya-city, Tochigi, 320-0834, Japan.'}, {'ForeName': 'Tomohide', 'Initials': 'T', 'LastName': 'Sugiyama', 'Affiliation': 'Division of Thoracic Oncology, Tochigi Cancer Center, 4-9-13, Yonan, Utsunomiya-city, Tochigi, 320-0834, Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Tokito', 'Affiliation': 'Division of Respirology, Neurology, and Rheumatology, Department ofInternal Medicine, Kurume University School of Medicine, 67, Asahimachi, Kurume-city, Fukuoka, 830-0011, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Seki', 'Affiliation': 'Division of Medical oncology, Department of Internal Medicine, Teikyo University School of Medicine, 2-11-1, Kaga, Itabashi-ku, Tokyo, 173-0014, Japan.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Hamada', 'Affiliation': 'Division of Molecular Pharmacology, National Cancer Center Research Institute, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': ""Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, 56, Okazawa-cho, Hodogaya-ku, Yokohama city, Kanagawa, 240-8555, Japan.""}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'Department of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1, Kitasato, Minami-ku, Sagamihara city, Kanagawa, 252-0375, Japan.'}]",Investigational new drugs,['10.1007/s10637-020-01031-z']
2374,33159697,Impact of an Advance Care Planning Video Intervention on Care of Short-Stay Nursing Home Patients.,"BACKGROUND/OBJECTIVES
To assess whether an advance care planning (ACP) video intervention impacts care among short-stay nursing home (NH) patients.
DESIGN
PRagmatic trial of Video Education in Nursing Homes (PROVEN) was a pragmatic cluster randomized clinical trial.
SETTING
A total of 360 NHs (N = 119 intervention, N = 241 control) owned by two healthcare systems.
PARTICIPANTS
A total of 2,538 and 5,290 short-stay patients with advanced dementia or cardiopulmonary disease (advanced illness) in the intervention and control arms, respectively; 23,302 and 50,815 short-stay patients without advanced illness in the intervention and control arms, respectively.
INTERVENTION
Five ACP videos were available on tablets or online. Designated champions at each intervention facility were instructed to offer a video to patients (or proxies) on admission. Control facilities used usual ACP practices.
MEASUREMENTS
Follow-up time was at most 100 days for each patient. Outcomes included hospital transfers per 1000 person-days alive and the proportion of patients experiencing more than one hospital transfer, more than one burdensome treatment (tube-feeding, parenteral therapy, invasive mechanical intervention, and intensive care unit admission), and hospice enrollment. Champions recorded whether a video was offered in the patients' electronic medical record.
RESULTS
There was no significant reduction in hospital transfers per 1000 person-days alive in the intervention versus control groups with advanced illness (rate (95% confidence interval (CI)), 12.3 (11.6-13.1) vs 13.2 (12.5-13.7); rate difference: -0.8; 95% CI = -1.8-0.2)). There was a nonsignificant reduction in hospital transfers per 1000 person-days alive in the intervention versus control among short-stay patients without advanced illness. Secondary outcomes did not differ between groups among patients with and without advanced illness. Based on champion only reports 14.2% and 15.3% of eligible short-stay patients with and without advanced illness were shown videos, respectively.
CONCLUSION
An ACP video program did not significantly reduce hospital transfers, burdensome treatment, or hospice enrollment among short-stay NH patients; however, fidelity to the intervention was low.",2020,"There was no significant reduction in hospital transfers per 1000 person-days alive in the intervention versus control groups with advanced illness (rate (95% confidence interval (CI)), 12.3 (11.6-13.1) vs 13.2 (12.5-13.7); rate difference: -0.8; 95% CI = -1.8-0.2)).","['A total of 360 NHs (N = 119 intervention, N = 241 control) owned by two healthcare systems', 'short-stay nursing home (NH) patients', 'A total of 2,538 and 5,290 short-stay patients with advanced dementia or cardiopulmonary disease (advanced illness) in the intervention and control arms, respectively; 23,302 and 50,815 short-stay patients without advanced illness in the intervention and control arms, respectively', 'Care of Short-Stay Nursing Home Patients', 'Nursing Homes (PROVEN']","['Advance Care Planning Video Intervention', 'advance care planning (ACP) video intervention', 'Video Education']","['hospital transfers per 1000 person-days alive and the proportion of patients experiencing more than one hospital transfer, more than one burdensome treatment (tube-feeding, parenteral therapy, invasive mechanical intervention, and intensive care unit admission), and hospice enrollment', 'hospital transfers, burdensome treatment, or hospice enrollment', 'hospital transfers']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0034072', 'cui_str': 'Cor pulmonale'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3658215', 'cui_str': 'Practical Clinical Trials'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]",,0.111724,"There was no significant reduction in hospital transfers per 1000 person-days alive in the intervention versus control groups with advanced illness (rate (95% confidence interval (CI)), 12.3 (11.6-13.1) vs 13.2 (12.5-13.7); rate difference: -0.8; 95% CI = -1.8-0.2)).","[{'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Loomer', 'Affiliation': 'Department of Economics, Labovitz School of Business and Economics, Duluth, Minnesota, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Ogarek', 'Affiliation': 'Centers for Gerontology and Healthcare Research, Department of Health Services, Policy and Practice, School of Public Health, Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Mitchell', 'Affiliation': 'Hebrew SeniorLife, Hinda and Arthur Marcus Institute for Aging Research, Boston, Massachusetts, USA.'}, {'ForeName': 'Angelo E', 'Initials': 'AE', 'LastName': 'Volandes', 'Affiliation': 'General Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Roee', 'Initials': 'R', 'LastName': 'Gutman', 'Affiliation': 'Department of Biostatistics, School of Public Health, Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Gozalo', 'Affiliation': 'Centers for Gerontology and Healthcare Research, Department of Health Services, Policy and Practice, School of Public Health, Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'McCreedy', 'Affiliation': 'Centers for Gerontology and Healthcare Research, Department of Health Services, Policy and Practice, School of Public Health, Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mor', 'Affiliation': 'Centers for Gerontology and Healthcare Research, Department of Health Services, Policy and Practice, School of Public Health, Brown University, Providence, Rhode Island, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16918']
2375,30833645,Impact of key pinch strength on patient preference for inflatable penile prosthesis: a prospective study comparing Coloplast™ and AMS™ models.,"Our purpose was to determine if key pinch strength is predictive of patient preference for a single IPP model among three currently available models (Coloplast™ Titan, Coloplast™ Titan Touch, and the Boston Scientific AMS 700™). We prospectively recruited men without penile prostheses over 65 years old from our urology clinic. Demographic and medical history were recorded. To measure key pinch strength study participants squeezed a dynamometer between their thumb and index finger while seated with their arm resting at 90°; the strongest of three attempts was recorded. Participants were asked to operate three inflatable penile prosthesis devices installed within identical penis models. The number of pumps required to achieve erection with each device was recorded. Participants were asked to rate difficulty of inflation on a 1-5 scale. Participants ranked, from best to worst, which device they preferred based on ease of inflation. A total of 100 men completed the study. Median age and key pinch strength were 70.0 years and 19.0 pounds. Coloplast Titan was the most favored pump based on ease of inflation (58%). The median age, median key pinch strength, and median number of pumps required for erection were similar among men that favored Coloplast Titan as compared with AMS 700 and Coloplast Titan Touch. Multivariate linear regression of the 1-5 rating scale revealed lower grip strength to be associated with increased difficulty of inflation of Coloplast Titan Touch (p = 0.045). No other factors were associated with increased difficulty of inflation. Men with below-average key pinch strength may benefit from being offered a model other than Coloplast Titan Touch. Whether these findings translate to men who have already received implants remains to be determined. Nevertheless, evaluation of pinch strength should be considered in men prior to implantation of IPP.",2020,Multivariate linear regression of the 1-5 rating scale revealed lower grip strength to be associated with increased difficulty of inflation of Coloplast Titan Touch (p = 0.045).,"['100 men completed the study', 'patient preference for inflatable penile prosthesis', 'recruited men without penile prostheses over 65 years old from our urology clinic']",['key pinch strength'],"['Median age and key pinch strength', 'difficulty of inflation of Coloplast Titan Touch', 'difficulty of inflation', 'median age, median key pinch strength, and median number of pumps required for erection']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0182504', 'cui_str': 'Inflatable penile prosthesis'}, {'cui': 'C0030850', 'cui_str': 'Penile prosthesis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3812395', 'cui_str': 'Urology clinic'}]","[{'cui': 'C0429272', 'cui_str': 'Key pinch'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0429272', 'cui_str': 'Key pinch'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0242756', 'cui_str': 'Titan'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}]",100.0,0.0196998,Multivariate linear regression of the 1-5 rating scale revealed lower grip strength to be associated with increased difficulty of inflation of Coloplast Titan Touch (p = 0.045).,"[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Masterson', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, FL, USA. Jmm557@med.miami.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Horodyski', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Kineish', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Taylor P', 'Initials': 'TP', 'LastName': 'Kohn', 'Affiliation': 'Department of Urology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Ranjith', 'Initials': 'R', 'LastName': 'Ramasamy', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, FL, USA.'}]",International journal of impotence research,['10.1038/s41443-019-0129-8']
2376,31088111,Intravitreal aflibercept efficacy in neovascular age-related macular degeneration with suboptimal response to anti-vascular endothelial growth factor-A therapy.,"IMPORTANCE
To provide new insights into aflibercept effect in non-naive-treated patients with neovascular age-related macular degeneration.
PURPOSE
To assess the efficacy of intravitreal aflibercept in patients with neovascular age-related macular degeneration without optimal response to previous anti-vascular endothelial growth factor A therapy.
DESIGN
Single-arm, multi-centre, prospective study.
PARTICIPANTS
Patients ⩾50 years with active neovascular age-related macular degeneration, best-corrected visual acuity between 20/32 and 20/320 with suboptimal response to ranibizumab or bevacizumab.
METHODS
Aflibercept was administered monthly (3-first months), and bimonthly thereafter until month 8. Anatomical and functional outcomes were assessed.
MAIN OUTCOME MEASURE
Percentage of eyes without intra or subretinal fluid on optical coherence tomography after 3-monthly loading doses of aflibercept.
RESULTS
A total of 46 patients were included. At week 12, 45.7% (95% confidence interval: 31.5%-60.1%) of eyes showed no fluid on optical coherence tomography. The mean (standard deviation) best-corrected visual acuity increased from 65.1 (8.3) to 69.6 (8.1) letters (+4.5 (5.8) p < 0.0001) and was stabilized at week 40 as compared to baseline. Mean central macular thickness decreased from 430 (119) µm to 323 (100) µm at week 12 (-107 (90) µm, p < 0.0001) and was reduced at week 40 (-46 (111) µm, p = 0.0056). At week 40, 21.7% (95% confidence interval: 9.8%-33.7%) had no fluid. There was a case of presumed noninfectious endophthalmitis that was successfully managed.
CONCLUSION
Almost half of patients presented no fluid on optical coherence tomography at week 12, and there was a clinically significant improvement in best-corrected visual acuity. At week 40, one in five patients did not show intra or subretinal fluid, central macular thickness decreased and best-corrected visual acuity was stabilized compared to baseline.",2020,"At week 12, 45.7% (95% confidence interval: 31.5%-60.1%) of eyes showed no fluid on optical coherence tomography.","['non-naive-treated patients with neovascular age-related macular degeneration', 'A total of 46 patients were included', 'Patients ⩾50 years with active neovascular age-related macular degeneration, best-corrected visual acuity between 20/32 and 20/320 with suboptimal response to', 'patients with neovascular age-related macular degeneration without optimal response to previous anti-vascular endothelial growth factor A therapy']","['intravitreal aflibercept', 'ranibizumab or bevacizumab']","['Percentage of eyes without intra or subretinal fluid on optical coherence tomography', 'mean (standard deviation) best-corrected visual acuity', 'Mean central macular thickness', 'intra or subretinal fluid, central macular thickness decreased and best-corrected visual acuity', 'optical coherence tomography', 'best-corrected visual acuity']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}]",46.0,0.419419,"At week 12, 45.7% (95% confidence interval: 31.5%-60.1%) of eyes showed no fluid on optical coherence tomography.","[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Monés', 'Affiliation': 'Institut de la Màcula, Barcelona, Spain.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Biarnés', 'Affiliation': 'Institut de la Màcula, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of ophthalmology,['10.1177/1120672119848961']
2377,31169023,Vision-related quality of life in patients treated for myopic choroidal neovascularization: A post hoc analysis of the OLIMPIC study.,"PURPOSE
To investigate vision-related quality of life in patients referred to the Italian Retina Services for intravitreal ranibizumab treatment for choroidal neovascularization due to pathologic myopia.
DESIGN
Post hoc analysis of a multicenter, interventional phase IIIb study (OLIMPIC).
METHODS
Patients with either previously untreated (naïve) or treated choroidal neovascularization due to pathologic myopia were enrolled. Vision-related quality of life was measured using the Italian version of the Impact of Vision Impairment Questionnaire with scores from 0 (no impact) to 5 (severe impact). Burden of illness data were collected regarding income, and personal and public resource use.
RESULTS
In the 200 included subjects, mean best-corrected visual acuity in the better eye was 68.3 Early Treatment Diabetic Retinopathy Study letters (standard deviation: 15.2) compared with 42.5 Early Treatment Diabetic Retinopathy Study letters (standard deviation: 23.3) in the worse eye. The proportion of better eyes affected by choroidal neovascularization was 147/200 (73.5%). In multivariable analyses, lower better eye, but not worse eye, best-corrected visual acuity was associated with lower vision-related quality of life (per 10 fewer letters, beta: + 0.17, p < 0.001). An annual income below 20,000 euros was also associated with lower vision-related quality of life (beta: + 0.38; standard error: 0.13, p = 0.004). Moreover, in univariate analyses, increasing income level was linearly associated with better presenting best-corrected visual acuity in the better eye (p < 0.003), with a difference of 15 Early Treatment Diabetic Retinopathy Study letters for patient income <20,000 euros compared with >70,000 euros.
CONCLUSION
Italian patients with myopic choroidal neovascularization and a low income presented with lower better-eye best-corrected visual acuity and lower vision-related quality of life compared with those with a higher income. Future research should investigate disease awareness and candidacy issues that may influence the quality of life of patients.",2020,"In multivariable analyses, lower better eye, but not worse eye, best-corrected visual acuity was associated with lower vision-related quality of life (per 10 fewer letters, beta: + 0.17, p < 0.001).","['patients referred to the Italian Retina Services for intravitreal ranibizumab treatment for choroidal neovascularization due to pathologic myopia', 'patients treated for myopic choroidal neovascularization', 'Italian patients with myopic choroidal neovascularization', '200 included subjects, mean best-corrected visual acuity in the better eye was 68.3 Early Treatment Diabetic Retinopathy Study letters (standard deviation: 15.2) compared with 42.5 Early Treatment Diabetic Retinopathy Study letters (standard deviation: 23.3) in the worse eye', 'Patients with either previously untreated (naïve) or treated choroidal neovascularization due to pathologic myopia were enrolled']",[],"['lower vision-related quality of life', 'Vision-related quality of life', 'choroidal neovascularization', 'better-eye best-corrected visual acuity and lower vision-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3537442', 'cui_str': 'Pathologic myopia'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C3665926', 'cui_str': 'Myopic choroidal neovascularization'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",[],"[{'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}]",,0.252005,"In multivariable analyses, lower better eye, but not worse eye, best-corrected visual acuity was associated with lower vision-related quality of life (per 10 fewer letters, beta: + 0.17, p < 0.001).","[{'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Virgili', 'Affiliation': 'Department of Translational Surgery and Medicine, Eye Clinic, University of Florence, Florence, Italy.'}, {'ForeName': 'Mariacristina', 'Initials': 'M', 'LastName': 'Parravano', 'Affiliation': 'Ophthalmology, IRCCS - Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Viola', 'Affiliation': 'Ophthalmology, Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Varano', 'Affiliation': 'Ophthalmology, IRCCS - Fondazione Bietti, Rome, Italy.'}]",European journal of ophthalmology,['10.1177/1120672119853745']
2378,31189759,Association of Non-LDL Indices with Recurrent Stroke Risk while on Lipid-Modifying Therapy.,"AIMS
Low-density lipoprotein (LDL)-lowering statin therapy is an established secondary stroke prevention strategy. However, the differential impact of key non-LDL levels on recurrent stroke risk, while on lipid-modifying therapy (LT), remains unclear.
METHODS
We analyzed the dataset of a multicenter trial involving 3640 recent (＜4 months) noncardioembolic stroke patients followed for 2 years. Participants were categorized into four groups of presumed improving lipid profile: level 0, no LT prescribed; level I, LT use with low high-density lipoprotein cholesterol (HDL-C) (＜40 mg/dL for men; ＜50 mg/dL for women); level II, LT use with high HDL-C (≥ 40 mg/dL and ≥ 50 mg/dL, respectively); and level III, level II with low triglycerides (＜150 mg/dL). Independent associations of LT category with stroke, major vascular events (MVEs; stroke/coronary heart disease/vascular death), and all-cause death were assessed.
RESULTS
LTs were mostly statins (＞95%). The unadjusted recurrent stroke rate declined with LT category level (9.2% for level 0; 8.4% for level I; 7.5% for level II; and 5.7% for level III). Compared with level 0, the adjusted hazard ratio of stroke for level I was 0.78 (95% confidence interval (CI), 0.59-1.03), level II 0.80 (0.54-1.18), and level III 0.63 (0.43-0.91). Multivariable analyses of MVEs and all-cause death followed a similar pattern of declining risk with higher LT category level.
CONCLUSIONS
Compared with the nonuse of LT, there may be a hierarchy of residual vascular risk after stroke by non-LDL type and target, while on LT. Particularly, stroke patients with low HDL-C levels on LT may benefit from additional therapeutic strategies to improve their outcomes.",2020,"Compared with level 0, the adjusted hazard ratio of stroke for level I was 0.78 (95% confidence interval (CI), 0.59-1.03), level II 0.80 (0.54-1.18), and level III 0.63 (0.43-0.91).","['3640 recent (＜4 months) noncardioembolic stroke patients followed for 2 years', 'Participants were categorized into four groups of presumed improving lipid profile: level 0, no LT prescribed; level I, LT use with low high-density lipoprotein cholesterol (HDL-C) (＜40 mg/dL for men; ＜50 mg/dL for women); level II, LT use with high HDL-C (≥ 40 mg/dL and ≥ 50 mg/dL, respectively); and level III, level II with low triglycerides (＜150 mg/dL', 'stroke patients with low HDL-C levels on LT']","['Low-density lipoprotein (LDL)-lowering statin therapy', 'Lipid-Modifying Therapy']","['adjusted hazard ratio of stroke for level I', 'unadjusted recurrent stroke rate declined with LT category level', 'LT category with stroke, major vascular events (MVEs; stroke/coronary heart disease/vascular death), and all-cause death']","[{'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0151691', 'cui_str': 'High density lipoprotein decreased'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441926', 'cui_str': 'Level II'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0858892', 'cui_str': 'Triglycerides low'}]","[{'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",3640.0,0.0976907,"Compared with level 0, the adjusted hazard ratio of stroke for level I was 0.78 (95% confidence interval (CI), 0.59-1.03), level II 0.80 (0.54-1.18), and level III 0.63 (0.43-0.91).","[{'ForeName': 'Jong-Ho', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Myongji Hospital, Hanyang University College of Medicine.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Ovbiagele', 'Affiliation': 'Department of Neurology, University of California.'}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.49304']
2379,33159734,"Effects of post-isometric relaxation, myofascial trigger point release and routine physical therapy in management of acute mechanical neck pain: a randomized controlled trial.","Objectives
To compare the effects of post-isometric relaxation, myofascial trigger point release and routine physical therapy on pain, disability and cervical range of motion in patients with acute mechanical neck pain.
METHODS
The randomised control trial was conducted at the District Headquarter Hospital in Nowshehra, Pakistan, from July to December 2017 and comprised subjects of either gender aged 16-49 years with acute neck pain. They were randomised into three groups; post-isometric relaxation group 1, myofascial trigger point release group 2 and routine physical therapy group 3. Neck disability index, numeric pain rating scale and cervical goniometry were documented before intervention, after the first session and after 6 sessions in two weeks. Data was analysed using SPSS 21.
RESULTS
Of the 60 patients, there were 20(33.3%) in each of the three groups. Mean age in group 1 was 32.25±9.56 years, group 2 2.35±9.05 years and in group 3 it was 32.75±7.82 years. Scores for neck disability index and numeric pain rating scale as well as rotation to right and left showed significant difference among the groups post-treatment (p<0.05). Within group analysis showed significant improvements in all parameters post-treatment in all the groups (p<0.0001).
CONCLUSIONS
Acute mechanical neck pain treated with post-isometric relaxation technique had more and faster effect in decreasing pain and disability and in improving mobility.",2020,"Within group analysis showed significant improvements in all parameters post-treatment in all the groups (p<0.0001).
","['60 patients', 'District Headquarter Hospital in Nowshehra, Pakistan, from July to December 2017 and comprised subjects of either gender aged 16-49 years with acute neck pain', 'acute mechanical neck pain', 'patients with acute mechanical neck pain']","['post-isometric relaxation technique', 'post-isometric relaxation group 1, myofascial trigger point release group 2 and routine physical therapy group 3', 'post-isometric relaxation, myofascial trigger point release and routine physical therapy']","['Scores for neck disability index and numeric pain rating scale', 'Neck disability index, numeric pain rating scale and cervical goniometry', 'pain, disability and cervical range of motion', 'pain and disability and in improving mobility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0035029', 'cui_str': 'Relaxation technique'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",,0.0461549,"Within group analysis showed significant improvements in all parameters post-treatment in all the groups (p<0.0001).
","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Junaid', 'Affiliation': 'Department of Physiotherapy, Government District Headquarter Hospital, Nowshera, Khyber Pukhtunkhwa.'}, {'ForeName': 'Irum', 'Initials': 'I', 'LastName': 'Yaqoob', 'Affiliation': 'Riphah International University, Islamabad, Pakistan.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Shakil Ur Rehman', 'Affiliation': 'Riphah College Of Rehabilitation Sciences, Riphah International University, Islamabad, Pakistan.'}, {'ForeName': 'Misbah', 'Initials': 'M', 'LastName': 'Ghous', 'Affiliation': 'Riphah College of Rehabilitation Sciences, Riphah International University, Islamabad, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.15939']
2380,33159735,Effectiveness of muscle energy technique as compared to Maitland mobilisation for the treatment of chronic sacroiliac joint dysfunction.,"OBJECTIVE
To compare the effectiveness of Muscle Energy Technique (MET) with Maitland mobilisations when using lumbopelvic stability exercises as an adjunct therapy with them in reducing pain and disability in patients with sacroiliac joint dysfunction (SIJD).
Methodology
A randomised controlled trial was conducted at physical therapy departments of Khyber Teaching Hospital, Lady Reading Hospital and Rehab Polyclinic, Peshawar, Pakistan and comprised of data over a to a six-month period from January 2015 to June 2015. Sixty participants (both male and female with an age range of 25-55 years) were randomly assigned to two equal groups of 30 (50%) each by chit-box method. Group-A of 30 patients (experimental group) was treated with Muscle Energy Technique (MET). Group-B of 30 patients (control group) was treated with Maitland Mobilizations at sacroiliac joint. Lumbopelvic stability exercises were given to both groups. The treatment outcomes were measured on the first day and then after 4 weeks (12 sessions) from each subject's pain and disability levels by using Visual Analogue Scale (VAS) for measuring pain and Modified Oswestry Disability Index (MODI) for measuring disability.
RESULTS
The paired sample statistics for intra-group analysis of the VAS and MODI showed a significant difference in values i.e. for Group-A, VAS was 16.699 with p-value 0.000 and MODI was 29.125 with p-value 0.000 while for Group-B, VAS was 18.687 with p-value 0.001 and MODI was 28.607 with p-value 0.001. The independent samples test for inter-group analysis of pre-VAS and post-VAS were 0.662 with 0.510 p-value and 1.000 with 0.321 p-value respectively while of pre-MODI and post-MODI were -1.482 with 0.144 p-value and -0.114 with 0.909 p-value respectively This showed an insignificant difference in pain and disability outcomes between the groups.
CONCLUSIONS
MET and Maitland mobilisations are both effective in treating the chronic sacroiliac joint dysfunction when using lumbopelvic stabilisation exercises as an adjunct therapy with them.",2020,"The paired sample statistics for intra-group analysis of the VAS and MODI showed a significant difference in values i.e. for Group-A, VAS was 16.699 with p-value 0.000 and MODI was 29.125 with p-value 0.000 while for Group-B, VAS was 18.687 with p-value 0.001 and MODI was 28.607 with p-value 0.001.","['patients with sacroiliac joint dysfunction (SIJD', 'chronic sacroiliac joint dysfunction', 'Sixty participants (both male and female with an age range of 25-55 years', 'physical therapy departments of Khyber Teaching Hospital, Lady Reading Hospital and Rehab Polyclinic, Peshawar, Pakistan and comprised of data over a to a six-month period from January 2015 to June 2015']","['Maitland Mobilizations at sacroiliac joint', 'muscle energy technique', 'lumbopelvic stabilisation exercises', 'lumbopelvic stability exercises', 'Muscle Energy Technique (MET', 'Lumbopelvic stability exercises', 'Muscle Energy Technique (MET) with Maitland mobilisations']","['pain and disability', 'pain and disability outcomes', 'pain and disability levels by using Visual Analogue Scale (VAS) for measuring pain and Modified Oswestry Disability Index (MODI) for measuring disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036036', 'cui_str': 'Sacroiliac joint structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0036036', 'cui_str': 'Sacroiliac joint structure'}, {'cui': 'C1562466', 'cui_str': 'Muscle energy technique'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",,0.0531749,"The paired sample statistics for intra-group analysis of the VAS and MODI showed a significant difference in values i.e. for Group-A, VAS was 16.699 with p-value 0.000 and MODI was 29.125 with p-value 0.000 while for Group-B, VAS was 18.687 with p-value 0.001 and MODI was 28.607 with p-value 0.001.","[{'ForeName': 'Faryal', 'Initials': 'F', 'LastName': 'Zaidi', 'Affiliation': 'University Institute of Physical Therapy, The University of Lahore Islamabad Campus, Pakistan.'}, {'ForeName': 'Ishaq', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'University Institute of Physical Therapy, The University of Lahore Islamabad Campus, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.43722']
2381,33159736,Comparing low fidelity simulation/model and hybrid simulation techniques for teaching how to perform intramuscular injections: a case control study.,"OBJECTIVE
To compare low-fidelity simulation/model and hybrid simulation techniques for teaching how to perform intramuscular injections.
METHODS
The case control study was conducted at the Department of Midwifery, Adnan Menderes University, Aydin, Turkey, from May 2 to 25, 2018, and comprised students enrolled in the course of Basic Principles and Practices in Midwifery II. The students were randomly divided into intervention group A and control group B. Those in group A were taught intramuscular injection at an assembly which was prepared through hybrid simulation method, while those in group B made use of the model routinely employed in the midwifery programme. Data was collected using a descriptive characteristics form, the General Self-Efficacy Scale, the State Trait Anxiety Inventory and the Guide to Performing Intramuscular Injections into the Ventro-gluteal Site. Data was analysed using SPSS 20.
RESULTS
Of the 73 students, 37(50.7%) were in group A and 36(49.3%) in group B. There was no difference in terms of age between the groups (p>0.05). Group A had a better total General Self-Efficacy Scale scores compared to group B (p<0.05). Mean score of group A in State-Trait Anxiety Inventory was lower than that of group B (p<0.05). The mean score of group A was also higher in the Guide to Performing Intramuscular Injections into the Ventrogluteal Site compared to group B (p<0.05).
CONCLUSIONS
Students using a hybrid simulation method had better levels of self-efficacy and skill as well as lower levels of anxiety compared to those trained on the conventional method.",2020,Group A had a better total General Self-Efficacy Scale scores compared to group B (p<0.05).,"['Department of Midwifery, Adnan Menderes University, Aydin, Turkey, from May 2 to 25, 2018, and comprised students enrolled in the course of Basic Principles and Practices in Midwifery II']",[],"['total General Self-Efficacy Scale scores', 'levels of self-efficacy and skill as well as lower levels of anxiety', 'Mean score of group A in State-Trait Anxiety Inventory', 'General Self-Efficacy Scale, the State Trait Anxiety Inventory']","[{'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",,0.0203795,Group A had a better total General Self-Efficacy Scale scores compared to group B (p<0.05).,"[{'ForeName': 'Keziban', 'Initials': 'K', 'LastName': 'Amanak', 'Affiliation': 'Department of Midwifery, Adnan Menderes University, Aydin, Turkey.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.27454']
2382,33159737,Comparison of effectiveness of WhatsApp and Facebook as learning tool for the students of a medical college.,"Objective
To compare the effectiveness of Facebook and WhatsApp as learning tools for undergraduate medical students in ophthalmology.
METHODS
The quantitative, quasi-experimental study was conducted at Khawaja Muhammad Safdar Medical College, Sialkot, Pakistan from October 2017 to March 2018, and comprised 4th year medical students. A pre-test of ophthalmology topics was taken and participants were divided into Facebook and WhatsApp groups by gender-based stratified randomisation. Four topics were taught through Facebook and WhatsApp to the relevant groups and post-test was taken using multiple choice questions. Data was analysed using SPSS 20.
RESULTS
Of the 100 students, 35(35%) were males and 65(65%) were females. The overall mean age was 21.76±0.85 years (range: 20-24 years of. The two groups had 50(50%) subjects each. A significant difference was found between pre- and post-test results of both the groups (p<0.001). There was no significant difference between the groups (p>0.05) neither the baseline nor post-intervention. There was significant difference along gender lines (p>0.05).
Conclusion
Facebook and WhatsApp as learning tools had no significant difference in terms of impact on the learning process.",2020,A significant difference was found between pre- and post-test results of both the groups (p<0.001).,"['Khawaja Muhammad Safdar Medical College, Sialkot, Pakistan from October 2017 to March 2018, and comprised 4th year medical students', 'undergraduate medical students in ophthalmology', 'Of the 100 students, 35(35%) were males and 65(65%) were females', 'students of a medical college']","['Facebook and WhatsApp', 'WhatsApp and Facebook']",[],"[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],[],4.0,0.0234465,A significant difference was found between pre- and post-test results of both the groups (p<0.001).,"[{'ForeName': 'Intzar', 'Initials': 'I', 'LastName': 'Hussain', 'Affiliation': 'Department of ophthalmology, Services Institute of Medical Sciences Lahore, Pakistan.'}, {'ForeName': 'Rehan Ahmed', 'Initials': 'RA', 'LastName': 'Khan', 'Affiliation': 'Islamic International Medical College, Riphah International University, Rawalpindi, Pakistan.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Mahboob', 'Affiliation': 'Assistant Professor of Medical Education, Khyber Medical University, Peshawar.'}, {'ForeName': 'Muhammad Zahid', 'Initials': 'MZ', 'LastName': 'Latif', 'Affiliation': 'Azra Naheed Medical College, The Superior University Lahore, Pakistan.'}, {'ForeName': 'Khadija', 'Initials': 'K', 'LastName': 'Waheed', 'Affiliation': 'Gynaecology and Obstetrics Department , King Edward Medical University, Lahore.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.35071']
2383,33160147,Tamoxifen related side effects and their impact on breast cancer incidence: A retrospective analysis of the randomised IBIS-I trial.,"BACKGROUND
Studies in the adjuvant setting have shown that endocrine therapy related side effects predict breast cancer recurrence risk. Here, we assess the relationship between early reported side effects and incidence of breast cancer in women randomised to tamoxifen for cancer prevention in the International Breast Intervention Study (IBIS)-I trial.
METHODS
Women randomised to tamoxifen in the IBIS-I trial and for whom side effect status was known at the 6-month follow-up visit were included in this analysis. Side effects included in this analysis were hot flushes, vaginal discharge, and vaginal dryness. The primary endpoint was all breast cancer and secondary endpoint was oestrogen receptor (ER) positive breast cancer. Cox proportional hazard models were used to investigate breast cancer incidence in the tamoxifen group with and without side effects reported within 6 months of randomisation.
RESULTS
Women randomised to tamoxifen and reporting hot flushes at the 6-month follow-up visit had a non-statistically significant increase in breast cancer compared to those without hot flushes (HR = 1.26 (0.98-1.62), P = 0.08). A significant higher breast cancer risk was observed for postmenopausal women who reported hot flushes at the 6-month follow-up visit compared to those without hot flushes (HR = 1.59 (1.12-2.26), P = 0.01). A higher risk was observed for ER-positive breast cancer in postmenopausal women (HR = 1.81 (1.19-2.74), P = 0.01). No significant associations between gynaecological side effects and breast cancer occurrence was observed.
CONCLUSIONS
Overall, no association between side effects reported at 6 months and subsequent breast cancer occurrence was observed. Some side effects might be useful markers for breast cancer occurrence in postmenopausal women.",2020,"A significant higher breast cancer risk was observed for postmenopausal women who reported hot flushes at the 6-month follow-up visit compared to those without hot flushes (HR = 1.59 (1.12-2.26), P = 0.01).","['Women randomised to', 'postmenopausal women']","['tamoxifen', 'Tamoxifen']","['breast cancer incidence', 'breast cancer and secondary endpoint was oestrogen receptor (ER) positive breast cancer', 'gynaecological side effects and breast cancer occurrence', 'breast cancer occurrence', 'hot flushes, vaginal discharge, and vaginal dryness', 'breast cancer', 'breast cancer risk', 'hot flushes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0227791', 'cui_str': 'Vaginal discharge'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0825288,"A significant higher breast cancer risk was observed for postmenopausal women who reported hot flushes at the 6-month follow-up visit compared to those without hot flushes (HR = 1.59 (1.12-2.26), P = 0.01).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hale', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Charterhouse Square, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Howell', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Wilmslow Road, Manchester, M20 4BX, UK.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Dowsett', 'Affiliation': 'Ralph Lauren Centre for Breast Cancer Research, London, SW3 6JJ, UK.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Cuzick', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Charterhouse Square, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Sestak', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Charterhouse Square, Queen Mary University London, London, EC1M 6BQ, UK. Electronic address: i.sestak@qmul.ac.uk.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.10.015']
2384,33160161,Nitrogen dioxide exposures from LPG stoves in a cleaner-cooking intervention trial.,"BACKGROUND
Liquefied petroleum gas (LPG) stoves have been promoted in low- and middle-income countries (LMICs) as a clean energy alternative to biomass burning cookstoves.
OBJECTIVE
We sought to characterize kitchen area concentrations and personal exposures to nitrogen dioxide (NO 2 ) within a randomized controlled trial in the Peruvian Andes. The intervention included the provision of an LPG stove and continuous fuel distribution with behavioral messaging to maximize compliance.
METHODS
We measured 48-hour kitchen area NO 2 concentrations at high temporal resolution in homes of 50 intervention participants and 50 control participants longitudinally within a biomass-to-LPG intervention trial. We also collected 48-hour mean personal exposures to NO 2 among a subsample of 16 intervention and 9 control participants. We monitored LPG and biomass stove use continuously throughout the trial.
RESULTS
In 367 post-intervention 24-hour kitchen area samples of 96 participants' homes, geometric mean (GM) highest hourly NO 2 concentration was 138 ppb (geometric standard deviation [GSD] 2.1) in the LPG intervention group and 450 ppb (GSD 3.1) in the biomass control group. Post-intervention 24-hour mean NO 2 concentrations were a GM of 43 ppb (GSD 1.7) in the intervention group and 77 ppb (GSD 2.0) in the control group. Kitchen area NO 2 concentrations exceeded the WHO indoor hourly guideline an average of 1.3 h per day among LPG intervention participants. GM 48-hour personal exposure to NO 2 was 5 ppb (GSD 2.4) among 35 48-hour samples of 16 participants in the intervention group and 16 ppb (GSD 2.3) among 21 samples of 9 participants in the control group.
DISCUSSION
In a biomass-to-LPG intervention trial in Peru, kitchen area NO 2 concentrations were substantially lower within the LPG intervention group compared to the biomass-using control group. However, within the LPG intervention group, 69% of 24-hour kitchen area samples exceeded WHO indoor annual guidelines and 47% of samples exceeded WHO indoor hourly guidelines. Forty-eight-hour NO 2 personal exposure was below WHO indoor annual guidelines for most participants in the LPG intervention group, and we did not measure personal exposure at high temporal resolution to assess exposure to cooking-related indoor concentration peaks. Further research is warranted to understand the potential health risks of LPG-related NO 2 emissions and inform current campaigns which promote LPG as a clean-cooking option.",2020,NO 2 concentrations exceeded the WHO indoor hourly guideline an average of 1.3 h per day among LPG intervention participants.,"[""96 participants' homes, geometric mean (GM) highest hourly""]","['LPG stove and continuous fuel distribution with behavioral messaging to maximize compliance', 'LPG intervention', 'Post-intervention', 'Liquefied petroleum gas (LPG) stoves', 'Nitrogen dioxide exposures from LPG stoves', 'nitrogen dioxide (NO 2 ']","['24-hour mean', 'NO 2 concentrations']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0028160', 'cui_str': 'Nitrogen dioxide'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0467508,NO 2 concentrations exceeded the WHO indoor hourly guideline an average of 1.3 h per day among LPG intervention participants.,"[{'ForeName': 'Josiah L', 'Initials': 'JL', 'LastName': 'Kephart', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Fandiño-Del-Rio', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Malpartida', 'Affiliation': 'Molecular Biology and Immunology Laboratory, Research Laboratory of Infectious Diseases, Department of Cell and Molecular Sciences, Faculty of Sciences and Philosophy, Universidad Peruana Cayetano Heredia, Lima, Peru; Biomedical Research Unit, Asociación Benéfica PRISMA, Lima, Peru.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Howard University, Washington, DC, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Steenland', 'Affiliation': 'Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Luke P', 'Initials': 'LP', 'LastName': 'Naeher', 'Affiliation': 'Department of Environmental Health Science, College of Public Health, The University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Gustavo F', 'Initials': 'GF', 'LastName': 'Gonzales', 'Affiliation': 'Laboratories of Investigation and Development, Department of Biological and Physiological Sciences, Faculty of Sciences and Philosophy, Universidad Peruana Cayetano Heredia, Lima, Peru; High Altitude Research Institute, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Marilu', 'Initials': 'M', 'LastName': 'Chiang', 'Affiliation': 'Biomedical Research Unit, Asociación Benéfica PRISMA, Lima, Peru.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Program in Global Disease Epidemiology and Control, Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA. Electronic address: wcheckl1@jhmi.edu.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environment international,['10.1016/j.envint.2020.106196']
2385,33160256,'Everybody's Different: The Appearance Game'. A randomised controlled trial evaluating an appearance-related board game intervention with children aged 9-11 years.,"This study evaluated the effectiveness of an educational board game aimed at increasing knowledge of appearance-related issues, positive body image, media literacy, and acceptance of appearance diversity with British school children. Two hundred and fifty-nine children, aged 9-11 (Mage = 10.26), from three primary schools in South-West England participated in a two-arm matched cluster randomised controlled trial. Outcome measures were collected pre-, post- and at two-week follow-up. Knowledge of appearance-related issues significantly increased in the intervention group, compared to the control group post-intervention, but was not maintained at follow-up. There were no significant differences between groups for body appreciation, media literacy or acceptance of visible difference. Of the intervention arm, 78 % (n=117) they would like to play again and 85.3 % (n=128) thought other children would like to play. Qualitative data suggests participants learned the key messages of the game. The findings suggest 'Everybody's Different: The Appearance Game' is an enjoyable way to increase knowledge of appearance-related issues. In future, researchers should consider how to increase body appreciation, media literacy and acceptance of appearance diversity, for example by increasing the dosage of the game or using it in conjunction with discussions and lessons surrounding appearance diversity and appearance-altering conditions.",2020,"Knowledge of appearance-related issues significantly increased in the intervention group, compared to the control group post-intervention, but was not maintained at follow-up.","['children aged 9-11 years', 'Two hundred and fifty-nine children, aged 9-11 (Mage = 10.26), from three primary schools in South-West England participated in a two-arm matched cluster randomised controlled trial', 'British school children']","['appearance-related board game intervention', 'educational board game']","['body appreciation, media literacy or acceptance of visible difference']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205379', 'cui_str': 'Visible'}]",259.0,0.051015,"Knowledge of appearance-related issues significantly increased in the intervention group, compared to the control group post-intervention, but was not maintained at follow-up.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Guest', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: ella.guest@uwe.ac.uk.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jarman', 'Affiliation': 'La Trobe University, Melbourne, Victoria, Australia. Electronic address: H.Jarman@latrobe.edu.au.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sharratt', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: Nick.Sharratt@uwe.ac.uk.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Williamson', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: Heidi3.Williamson@uwe.ac.uk.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'White', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: Paul.White@uwe.ac.uk.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Harcourt', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: Diana2.Harcourt@uwe.ac.uk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Slater', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: Amy.Slater@uwe.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK.'}]",Body image,['10.1016/j.bodyim.2020.09.010']
2386,33160281,Effect of hemodiafiltration on measured physical activity: primary results of the HDFIT randomized controlled trial.,"BACKGROUND
Dialysis patients are typically inactive and their physical activity (PA) decreases over time. Uremic toxicity has been suggested as a potential causal factor of low PA in dialysis patients. Post-dilution high-volume online hemodiafiltration (HDF) provides greater higher molecular weight removal and studies suggest better clinical/patient-reported outcomes compared with hemodialysis (HD).
METHODS
HDFIT was a randomized controlled trial at 13 clinics in Brazil that aimed to investigate the effects of HDF on measured PA (step counts) as a primary outcome. Stable HD patients (vintage 3-24 months) were randomized to receive HDF or high-flux HD. Treatment effect of HDF on the primary outcome from baseline to 3 and 6 months was estimated using a linear mixed-effects model.
RESULTS
We randomized 195 patients (HDF 97; HD 98) between August 2016 and October 2017. Despite the achievement of a high convective volume in the majority of sessions and a positive impact on solute removal, the treatment effect HDF on the primary outcome was +538 [95% confidence interval (CI) -330 to 1407] steps/24 h after dialysis compared with HD, and was not statistically significant. Despite a lack of statistical significance, the observed size of the treatment effect was modest and driven by steps taken between 1.5 and 24.0 h after dialysis, in particular between 20 and 24 h (+197 steps; 95% CI -95 to 488).
CONCLUSIONS
HDF did not have a statistically significant treatment effect on PA 24 h following dialysis, albeit effect sizes may be clinically meaningful and deserve further investigation.",2020,"Post-dilution high-volume online hemodiafiltration (HDF) provides greater higher molecular weight removal and studies suggest better clinical/patient-reported outcomes compared with hemodialysis (HD).
","['dialysis patients', 'Stable HD patients (vintage 3-24\u2009months', '195 patients (HDF 97; HD 98) between August 2016 and October 2017', '13 clinics in Brazil']","['Post-dilution high-volume online hemodiafiltration (HDF', 'hemodiafiltration', 'HDF', 'HDF or high-flux HD']","['Uremic toxicity', 'physical activity']","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0445431', 'cui_str': 'After the filter'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",195.0,0.266364,"Post-dilution high-volume online hemodiafiltration (HDF) provides greater higher molecular weight removal and studies suggest better clinical/patient-reported outcomes compared with hemodialysis (HD).
","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pecoits-Filho', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': ''}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Poli-de-Figueiredo', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Américo Lourenço', 'Initials': 'AL', 'LastName': 'Cuvello-Neto', 'Affiliation': 'Hospital Alemão Oswaldo Cruz, São Paulo, SP, Brazil.'}, {'ForeName': 'Ana Beatriz Lesqueves', 'Initials': 'ABL', 'LastName': 'Barra', 'Affiliation': 'Fresenius Medical Care, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Priscila Bezerra', 'Initials': 'PB', 'LastName': 'Gonçalves', 'Affiliation': 'Pontifícia Universidade Católica do Paraná, Curitiba, PR, Brazil.'}, {'ForeName': 'Shimul', 'Initials': 'S', 'LastName': 'Sheth', 'Affiliation': 'Renal Research Institute, New York, NY,\xa0USA.'}, {'ForeName': 'Murilo', 'Initials': 'M', 'LastName': 'Guedes', 'Affiliation': 'Pontifícia Universidade Católica do Paraná, Curitiba, PR, Brazil.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Pontifícia Universidade Católica do Paraná, Curitiba, PR, Brazil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Calice-Silva', 'Affiliation': 'Fundação Pró Rim, Joinville, SC, Brazil.'}, {'ForeName': 'Manuel Carlos Martins', 'Initials': 'MCM', 'LastName': 'de Castro', 'Affiliation': 'Instituto de Nefrologia de Taubaté, Taubaté, SP, Brazil.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kotanko', 'Affiliation': 'Renal Research Institute, New York, NY,\xa0USA.'}, {'ForeName': 'Thyago Proenca', 'Initials': 'TP', 'LastName': 'de Moraes', 'Affiliation': 'Pontifícia Universidade Católica do Paraná, Curitiba, PR, Brazil.'}, {'ForeName': 'Jochen G', 'Initials': 'JG', 'LastName': 'Raimann', 'Affiliation': 'Renal Research Institute, New York, NY,\xa0USA.'}, {'ForeName': 'Maria Eugenia F', 'Initials': 'MEF', 'LastName': 'Canziani', 'Affiliation': 'Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa173']
2387,31391505,No modulation of pupil size and event-related pupil response by transcutaneous auricular vagus nerve stimulation (taVNS).,"Transcutaneous auricular vagus nerve stimulation (taVNS) bears therapeutic potential for a wide range of medical conditions. However, previous studies have found substantial interindividual variability in responsiveness to taVNS, and no reliable predictive biomarker for stimulation success has been developed so far. In this study, we investigate pupil size and event-related pupil response as candidate biomarkers. Both measures have a direct physiological link to the activity of the locus coeruleus (LC), a brainstem structure and the main source of norepinephrine in the brain. LC activation is considered one of the key mechanisms of action of taVNS, therefore, we expected a clear increase of the pupillary measures under taVNS compared to sham (placebo) stimulation, such that it could serve as a prospective predictor for individual clinical and physiological taVNS effects in future studies. We studied resting pupil size and pupillary responses to target stimuli in an auditory oddball task in 33 healthy young volunteers. We observed stronger pupil responses to target than to standard stimuli. However, and contrary to our hypothesis, neither pupil size nor the event-related pupil response nor behavioral performance were modulated by taVNS. We discuss potential explanations for this negative finding and its implications for future clinical investigation and development of taVNS.",2019,"However, and contrary to our hypothesis, neither pupil size nor the event-related pupil response nor behavioral performance were modulated by taVNS.",['33 healthy young volunteers'],"['transcutaneous auricular vagus nerve stimulation (taVNS', 'Transcutaneous auricular vagus nerve stimulation (taVNS']","['pupil size and event-related pupil response', 'pupil responses', 'pupil size nor the event-related pupil response nor behavioral performance']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",33.0,0.0236674,"However, and contrary to our hypothesis, neither pupil size nor the event-related pupil response nor behavioral performance were modulated by taVNS.","[{'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Keute', 'Affiliation': 'Department of Neurology, Otto von Guericke University, Magdeburg, Germany.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Demirezen', 'Affiliation': 'Department of Neurology, Otto von Guericke University, Magdeburg, Germany.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Graf', 'Affiliation': 'Neuroprotection Group, German Center for Neurodegenerative Diseases, Magdeburg, Germany.'}, {'ForeName': 'Notger G', 'Initials': 'NG', 'LastName': 'Mueller', 'Affiliation': 'Department of Neurology, Otto von Guericke University, Magdeburg, Germany.'}, {'ForeName': 'Tino', 'Initials': 'T', 'LastName': 'Zaehle', 'Affiliation': 'Department of Neurology, Otto von Guericke University, Magdeburg, Germany. tino.zaehle@ovgu.de.'}]",Scientific reports,['10.1038/s41598-019-47961-4']
2388,31524161,ReadClear: An Assistive Reading Tool for People Living with Posterior Cortical Atrophy.,"BACKGROUND
Progressive reading impairment is an early and debilitating symptom of posterior cortical atrophy (PCA) arising from the progressive deterioration of visual processing skills.
OBJECTIVE
The goal of this study was to test the effectiveness of a purpose-built reading app (ReadClear) co-produced with people living with PCA and designed to reduce the reading difficulties experienced by this population (e.g., getting lost in the page and missing words when reading).
METHODS
Twenty subjects with PCA were included in a cross-over design home-based study aimed at determining whether ReadClear could 1) enhance the subjective reading experience (reading pleasantness) and 2) improve reading accuracy (reducing the number of reading errors) compared with a sham condition (a standard e-reader).
RESULTS
Reading using ReadClear provided a better subjective reading experience than sham (p = 0.018, d = 0.5) and significantly reduced the percentage of reading errors (p < 0.0001, r = 0.82), particularly errors due to omissions (p = 0.01, r = 0.50), repeated words (p = 0.002, r = 0.69), and regressions in the text (p = 0.003, r = 0.69). We found that different kinds of reading errors were related to specific neuropsychological profiles.
CONCLUSION
ReadClear can assist reading in people living with PCA by reducing the number of reading errors and improving the subjective reading experience of users.",2019,ReadClear can assist reading in people living with PCA by reducing the number of reading errors and improving the subjective reading experience of users.,"['People Living with Posterior Cortical Atrophy', 'Twenty subjects with PCA', 'people living with PCA']","['ReadClear', 'built reading app (ReadClear) co-produced with people living with PCA']","['percentage of reading errors', 'subjective reading experience (reading pleasantness) and 2) improve reading accuracy (reducing the number of reading errors']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C4275079', 'cui_str': 'Posterior cortical atrophy syndrome'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C4275079', 'cui_str': 'Posterior cortical atrophy syndrome'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",20.0,0.0380929,ReadClear can assist reading in people living with PCA by reducing the number of reading errors and improving the subjective reading experience of users.,"[{'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Suarez-Gonzalez', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology, University College London, London, UK.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Ocal', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology, University College London, London, UK.'}, {'ForeName': 'Ivanna', 'Initials': 'I', 'LastName': 'Pavisic', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology, University College London, London, UK.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Peacock', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology, University College London, London, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Naessens', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology, University College London, London, UK.'}, {'ForeName': 'Samrah', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Leff', 'Affiliation': 'Department of Brain Repair and Rehabilitation, UCL Institute of Neurology & Institute of Cognitive Neuroscience, Queen Square, London, UK.'}, {'ForeName': 'Keir X X', 'Initials': 'KXX', 'LastName': 'Yong', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology, University College London, London, UK.'}, {'ForeName': 'Sebastian J', 'Initials': 'SJ', 'LastName': 'Crutch', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology, University College London, London, UK.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190335']
2389,31824507,Dynamic Changes in Natural Killer Cell Subset Frequencies in the Absence of Cytomegalovirus Infection.,"Individuals lacking functional natural killer (NK) cells suffer severe, recurrent infections with cytomegalovirus (CMV), highlighting the critical role of NK cells in antiviral defense. Therefore, ongoing attempts to develop an efficacious vaccine to prevent CMV infection should potentially aim to elicit NK-cell antiviral responses as an accessory to conventional T- and B-cell based approaches. In this regard, CMV infection provokes marked phenotypic and functional differentiation of the NK-cell compartment, including development of adaptive NK cells that exhibit enhanced antiviral activity. We examined longitudinal blood samples collected from 40 CMV-seronegative adolescents to ascertain whether a CMV glycoprotein B (gB) vaccine in the absence of CMV infection can stimulate differentiation or expansion of CMV-associated subsets of NK cells. Study participants uniformly lacked the CMV-dependent NKG2C + subset of NK cells, suggesting that an adjuvanted CMV gB vaccine alone is an inadequate stimulus for sustained expansion of these cells. In contrast, we observed unexpected dynamic fluctuations in the frequency of NK cells lacking FcRγ, EAT-2, and SYK, which were independent of vaccination or CMV infection. Whereas, FcRγ neg NK cells in CMV infection are reported to express increased levels of the maturation marker CD57, the FcRγ neg NK cells observed in our CMV-negative vaccine cohort express less CD57 than their FcRγ + counterparts. The FcRγ neg NK cells in CMV-negative individuals were also functionally distinct from this subset in CMV infection, exhibiting comparable IFN-γ production and degranulation as FcRγ + NK cells in response to cytokine or antibody-dependent stimuli. These results suggest that frequencies of some NK cell subsets may increase in response to unknown environmental or inflammatory cues distinct from that which occurs after CMV infection. Greater understanding of the nature of the signals driving CMV-independent accumulation of these subsets should permit development of mechanisms to facilitate vaccine-driven expansion of CMV-reactive NK cells.",2019,"The FcRγ neg NK cells in CMV-negative individuals were also functionally distinct from this subset in CMV infection, exhibiting comparable IFN-γ production and degranulation as FcRγ + NK cells in response to cytokine or antibody-dependent stimuli.","['Individuals lacking functional natural killer (NK) cells suffer severe, recurrent infections with cytomegalovirus (CMV', '40 CMV-seronegative adolescents']",['CMV glycoprotein B (gB) vaccine'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0239998', 'cui_str': 'Recurrent infectious disease'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0111890', 'cui_str': 'glycoprotein B, cytomegalovirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],40.0,0.0240305,"The FcRγ neg NK cells in CMV-negative individuals were also functionally distinct from this subset in CMV infection, exhibiting comparable IFN-γ production and degranulation as FcRγ + NK cells in response to cytokine or antibody-dependent stimuli.","[{'ForeName': 'Ivayla E', 'Initials': 'IE', 'LastName': 'Gyurova', 'Affiliation': ""Center for Autoimmune Genomics and Etiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States.""}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Schlums', 'Affiliation': 'Department of Medicine, Center for Hematology and Regenerative Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Sucharew', 'Affiliation': ""Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States.""}, {'ForeName': 'Lilliam', 'Initials': 'L', 'LastName': 'Ambroggio', 'Affiliation': ""Sections of Emergency Medicine and Hospital Medicine, Department of Pediatrics, Children's Hospital Colorado, University of Colorado Denver, Denver, CO, United States.""}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Ochayon', 'Affiliation': ""Center for Autoimmune Genomics and Etiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States.""}, {'ForeName': 'Hannah Than', 'Initials': 'HT', 'LastName': 'Win', 'Affiliation': ""Center for Autoimmune Genomics and Etiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States.""}, {'ForeName': 'Yenan T', 'Initials': 'YT', 'LastName': 'Bryceson', 'Affiliation': 'Department of Medicine, Center for Hematology and Regenerative Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Bernstein', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, United States.'}, {'ForeName': 'Stephen N', 'Initials': 'SN', 'LastName': 'Waggoner', 'Affiliation': ""Center for Autoimmune Genomics and Etiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States.""}]",Frontiers in immunology,['10.3389/fimmu.2019.02728']
2390,33159796,Efficacy of a step-down regimen of oral prednisolone in axial spondyloarthritis: result of a double-blind randomized controlled trial (COBRA-AS Study).,"OBJECTIVES
To evaluate the efficacy and safety of a step-down regimen of oral prednisolone over 24 weeks in patients of axial SpA (axSpA).
METHODS
This proof-of-concept double-blind randomized controlled trial enrolled patients with active axSpA (BASDAI ≥4) having predominantly axial disease (≤1 active joint currently) and inadequate response to NSAIDs. They were randomized to receive either oral prednisolone (n = 32) or placebo (n = 33) at a dose of 60, 40, 30, 20, 15 and 10 mg daily for 1 week each, following which they received 5 mg prednisolone (or placebo) daily for 18 weeks. The primary endpoint was a 50% improvement in the BASDAI (BASDAI50) at week 24. Analysis was intention to treat.
RESULTS
A BASDAI50 was achieved by 12 of 32 patients (37.5%) in the prednisolone arm and 3 of 33 patients (9.1%) in the placebo arm at 24 weeks [difference 28.4% (95% CI 7.9, 46.7)]. However, there was no difference in achieving a 20 or 40% improvement in the Assessment of SpondyloArthritis international Society response between the groups. Although there was a significant intergroup difference in adjusted ΔBASDAI and ΔAnkylosing Spondylitis Disease Activity Score with CRP at 24 weeks, there was no difference at 12 weeks. There was also no significant difference in ΔBASFI, ΔBAS-G or ΔBASMI at 12 or 24 weeks. No serious adverse events were noted. There was significant weight gain in the first 12 weeks in the prednisolone group vs placebo [0.9 (s.d. 0.4) kg], but not at 24 weeks.
CONCLUSIONS
In this small study, oral prednisolone was efficacious in axSpA in achieving the primary outcome, but many crucial secondary outcomes such as functional improvement were not met. Its impact on bone loss was not studied.Trial registration: CTRI/2018/01/011342.",2020,"Although there was a significant intergroup difference in adjusted ΔBASDAI and ΔAnkylosing Spondylitis Disease Activity Score with CRP at 24 weeks, there was no difference at 12 weeks.","['patients of axial SpA (axSpA', 'axial spondyloarthritis', 'enrolled patients with active axSpA (BASDAI ≥4) having predominantly axial disease (≤1 active joint currently) and inadequate response to NSAIDs']","['placebo', 'prednisolone (or placebo', 'prednisolone', 'oral prednisolone']","['weight gain', 'efficacy and safety', 'BASDAI (BASDAI50', 'SpondyloArthritis international Society response', 'ΔBASFI, ΔBAS-G or ΔBASMI', 'adjusted ΔBASDAI and ΔAnkylosing Spondylitis Disease Activity Score with CRP', 'bone loss', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.763201,"Although there was a significant intergroup difference in adjusted ΔBASDAI and ΔAnkylosing Spondylitis Disease Activity Score with CRP at 24 weeks, there was no difference at 12 weeks.","[{'ForeName': 'Debashish', 'Initials': 'D', 'LastName': 'Mishra', 'Affiliation': ''}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Dhir', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'G S R S N K', 'Initials': 'GSRSNK', 'LastName': 'Naidu', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Aastha', 'Initials': 'A', 'LastName': 'Khullar', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Orthopedics, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh.'}, {'ForeName': 'Shefali', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa685']
2391,33159924,Lactated Ringers vs. Normal Saline Resuscitation for Mild Acute Pancreatitis: A Randomized Trial.,,2020,,['Mild Acute Pancreatitis'],['Lactated Ringers vs. Normal Saline Resuscitation'],[],"[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}]","[{'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]",[],,0.223254,,"[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': ""Department of Internal Medicine, Division of Gastroenterology, University of Southern California Keck School of Medicine; Center for Center for Pancreatic Disease, Brigham and Women's Hospital, Harvard Medical School.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ko', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, University of Southern California Keck School of Medicine.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Buitrago', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, University of Southern California Keck School of Medicine.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Hiramoto', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, University of Southern California Keck School of Medicine.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Hilson', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, University of Southern California Keck School of Medicine.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Buxbaum', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, University of Southern California Keck School of Medicine. Electronic address: jbuxbaum@usc.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2020.10.044']
2392,33159976,Multiple-dose clinical pharmacology of the selective orexin-1 receptor antagonist ACT-539313.,"AIMS
Compounds that selectively target orexin-1 receptors may be beneficial for the treatment of various disorders. The role of selective orexin-1 receptor antagonists (1-SORAs) in addictive behavior and stress/anxiety-related disturbances has been demonstrated in animals. ACT-539313, an orally active, potent 1-SORA, has been assessed in a clinical single-ascending dose study and exhibited good safety and tolerability. In the two reported studies on ACT-539313, multiple-dose pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability were investigated and in a proof-of-mechanism study a CO 2 challenge was applied as pharmacological model for induction of anxiety and panic symptoms (sequential inhalation of air, 7.5% CO 2 , and 35% CO 2 ).
METHODS
Two double-blind, placebo-controlled, randomized, multiple-dose studies included 58 healthy male and female subjects. In Study 1, multiple-ascending oral doses of 30, 100, and 200 mg twice daily (b.i.d.) ACT-539313 were investigated in 3 dose groups of 8 or 12 subjects (of whom 2 received placebo per dose group). Study 2 was conducted as a randomized two-way crossover design, enrolling 21 male and 9 female subjects who received 200 mg ACT-539313 or matching placebo b.i.d. for 2.5 days followed by a CO 2 challenge, with a washout period in between. PK, PD (objective and subjective measures of sedation, alertness, effects on central nervous system (CNS), and anxiety/panic symptoms), safety, and tolerability were assessed.
RESULTS
At steady state, ACT-539313 was rapidly absorbed with a median time to maximum plasma concentration of 1.8-2.3 h and eliminated with a mean half-life of 3.8-6.5 h. Overall exposure increased dose-proportionally. In Study 1, PD effects confirmed activity of ACT-539313 on the CNS, without consistent or marked effects of sedation, reduced alertness or visuo-motor impairment. In the CO 2 challenge, cortisol concentrations were lower during initial air inhalation after treatment with ACT-539313 compared to placebo, while no difference was detected after CO 2 inhalation. Trends for lower scores in subjective anxiety assessments were observed for ACT-539313. Besides reports of stress related to the challenge, the most frequently reported adverse events were somnolence and headache. No clinically relevant effects in other safety assessments were observed.
CONCLUSIONS
Multiple-dose administration of ACT-539313 was safe and well tolerated up to multiple doses of 200 mg b.i.d. The drug's PK properties as well as the pattern of a decrease in stress-related symptoms after the CO 2 challenge support further investigations of ACT-539313.",2020,"In the CO 2 challenge, cortisol concentrations were lower during initial air inhalation after treatment with ACT-539313 compared to placebo, while no difference was detected after CO 2 inhalation.","['enrolling 21 male and 9 female subjects who received 200\u202fmg', '58 healthy male and female subjects']","['ACT-539313', 'placebo', 'ACT-539313 or matching placebo b.i.d', 'selective orexin-1 receptor antagonists (1-SORAs']","['PK, PD (objective and subjective measures of sedation, alertness, effects on central nervous system (CNS), and anxiety/panic symptoms), safety, and tolerability', 'ACT-539313, multiple-dose pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability', 'safe and well tolerated', 'subjective anxiety assessments', 'cortisol concentrations', 'alertness or visuo-motor impairment']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1113688', 'cui_str': 'Orexin'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C1275624', 'cui_str': 'Porzana carolina'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",21.0,0.0816893,"In the CO 2 challenge, cortisol concentrations were lower during initial air inhalation after treatment with ACT-539313 compared to placebo, while no difference was detected after CO 2 inhalation.","[{'ForeName': 'Priska', 'Initials': 'P', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland. Electronic address: priska.kaufmann@idorsia.com.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Ort', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Golor', 'Affiliation': 'Parexel International GmbH, Spandauer Damm 130, 14050, Berlin, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Kornberger', 'Affiliation': 'Parexel International GmbH, Spandauer Damm 130, 14050, Berlin, Germany.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110166']
2393,33160091,Feasibility and preliminary efficacy of a positive psychology-based intervention to promote health behaviors in heart failure: The REACH for Health study.,"OBJECTIVE
Most patients with heart failure (HF) struggle to adhere to health behaviors, and existing health behavior interventions have significant limitations. We developed a 12-week, phone-delivered, combined positive psychology (PP) and motivational interviewing (MI) intervention to promote well-being and adherence to physical activity, diet, and medications. In this three-arm, randomized trial, we assessed the feasibility, acceptability, and preliminary efficacy of the intervention compared to treatment as usual and MI-alone conditions in 45 patients with HF and suboptimal health behavior adherence.
METHODS
Participants in the PP-MI or MI-alone conditions completed weekly phone sessions for 12 weeks. Those in PP-MI completed weekly PP exercises and set health behavior goals, while those in the MI-alone condition learned about HF-specific health behaviors and identified potential behavior changes. Primary study outcomes were feasibility (sessions completed) and acceptability (0-10 ratings of PP exercise ease and utility). The intervention's impact on psychological and behavioral outcomes was assessed using mixed effects regression analyses.
RESULTS
Participants in the PP-MI condition completed 73% of sessions and rated PP exercises as easy to complete (mean = 7.5 [SD 1.7] out of 10) and subjectively useful (mean = 7.5 [SD 1.6] out of 10). Compared to the control conditions, PP-MI led to medium effect-size improvements in positive affect (Cohen's d = 0.32-0.77), moderate to vigorous physical activity (d = 0.41-0.74), and medication adherence (d = 0.48-0.78).
CONCLUSION
This PP-MI intervention was feasible, well-accepted, and associated with promising improvements in well-being and health behavior outcomes. Larger trials are needed to examine this intervention's impact on health behavior adherence and other important outcomes (NCT03220204).",2020,"This PP-MI intervention was feasible, well-accepted, and associated with promising improvements in well-being and health behavior outcomes.","['patients with heart failure (HF', 'Participants in the PP-MI or MI-alone conditions completed weekly phone sessions for 12\xa0weeks', '45 patients with HF and suboptimal health behavior adherence', 'heart failure']","['positive psychology-based intervention', 'combined positive psychology (PP) and motivational interviewing (MI) intervention to promote well-being and adherence to physical activity, diet, and medications']","['health behavior adherence', 'feasibility (sessions completed) and acceptability (0-10 ratings of PP exercise ease and utility', 'psychological and behavioral outcomes', 'moderate to vigorous physical activity', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",45.0,0.039932,"This PP-MI intervention was feasible, well-accepted, and associated with promising improvements in well-being and health behavior outcomes.","[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Celano', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA. Electronic address: ccelano@mgh.harvard.edu.'}, {'ForeName': 'Melanie E', 'Initials': 'ME', 'LastName': 'Freedman', 'Affiliation': 'Department of Psychology, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Harnedy', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Cardiology Division, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA; Baim Institute for Clinical Research, Boston, MA, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Healy', 'Affiliation': ""Department of Neurology, Brigham and Women's Hospital, Boston, MA, USA; Departments of Neurology and Biostatistics, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110285']
2394,33160115,Safety and efficacy of apixaban thromboprophylaxis in cancer patients with metastatic disease: A post-hoc analysis of the AVERT trial.,"BACKGROUND
The risk of venous thromboembolism (VTE) is increased in patients with active cancer and the risk is highest in those with metastatic disease. The risks and benefits of thromboprophylaxis among cancer patients with metastatic disease initiating chemotherapy treatment are unknown. To address this important knowledge gap, we evaluated the efficacy and safety of apixaban thromboprophylaxis in patients with and without metastatic disease.
METHODS
Post-hoc analysis of the AVERT trial, which was a randomized, placebo-controlled, double-blind trial comparing apixaban therapy to placebo for VTE prophylaxis among cancer patients who were intermediate-to-high risk for VTE and who were initiating chemotherapy. The hazards ratios (HRs) for VTE and major bleeding episodes in patients with and without metastatic disease were calculated using a Cox regression model controlling for age, gender, and center.
RESULTS
A total of 574 patients underwent randomization and 365 patients could be stratified according to the presence (n = 138) or absence (n = 227) of metastatic disease. In patients with metastatic disease, those receiving apixaban had a significantly lower risk of VTE (HR 0.55; 95% CI 0.32 to 0.97) without a significant increase in major bleeding complications (HR 1.36 95% CI 0.27 to 6.93) compared to those on placebo. In patients without metastatic disease, the use of apixaban was also associated with a significantly lower risk of VTE (HR 0.34 95% CI 0.19 to 0.60) without a significant increase in major bleeding complications (HR 1.14 95% CI 0.08 to 15.91).
CONCLUSIONS
In patients with and without metastatic disease, apixaban thromboprophylaxis was associated with a significantly lower rate of VTE compared to placebo.",2020,"In patients with metastatic disease, those receiving apixaban had a significantly lower risk of VTE (HR 0.55; 95% CI 0.32 to 0.97) without a significant increase in major bleeding complications (HR 1.36 95% CI 0.27 to 6.93) compared to those on placebo.","['patients with active cancer', 'cancer patients with metastatic disease initiating', 'patients with and without metastatic disease', 'cancer patients who were intermediate-to-high risk for VTE and who were initiating chemotherapy', '574 patients underwent randomization and 365 patients could be stratified according to the presence (n\xa0=\xa0138) or absence (n\xa0=\xa0227) of metastatic disease', 'cancer patients with metastatic disease']","['apixaban therapy to placebo', 'placebo', 'apixaban thromboprophylaxis', 'chemotherapy']","['hazards ratios (HRs) for VTE and major bleeding episodes', 'Safety and efficacy', 'efficacy and safety', 'rate of VTE', 'risk of VTE', 'major bleeding complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",574.0,0.339079,"In patients with metastatic disease, those receiving apixaban had a significantly lower risk of VTE (HR 0.55; 95% CI 0.32 to 0.97) without a significant increase in major bleeding complications (HR 1.36 95% CI 0.27 to 6.93) compared to those on placebo.","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Knoll', 'Affiliation': ""Faculty of Medicine, Queen's University, Kingston, Canada; Department of Medicine University of Ottawa, the Ottawa Hospital Research Institute, Ottawa, Canada.""}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine University of Ottawa, the Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Department of Medicine University of Ottawa, the Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address: mcarrier@toh.ca.'}]",Thrombosis research,['10.1016/j.thromres.2020.10.026']
2395,32692805,Effectiveness of a normative nutrition intervention in Chilean pregnant women on maternal and neonatal outcomes: the CHiMINCs study.,"BACKGROUND
Some nutritional interventions have shown their efficacy in reducing gestational weight gain (GWG); however, their applicability in routine care is limited.
OBJECTIVE
We assessed the effectiveness of a low-intensity and high-coverage nutritional intervention on maternal and offspring outcomes; the intervention enhanced existing nutritional health care standards and practices at the primary health care level in Chile.
METHODS
This study was a cluster-randomized controlled trial of 12 primary health care centers (PHCCs) from Santiago, Chile. PHCCs were randomly allocated to either nutritional intervention [intervention group (IG), n = 5] or routine care [control group (CG), n = 7]. A total of 4631 pregnant women were recruited (IG, n = 2565; and CG, n = 2066). Primary outcomes were adequate GWG and glycemic control in mothers and birth weight, birth length, macrosomia, and large for gestational age in neonates. The intervention consisted of 4 key actions: training of health care professionals on nutritional recommendations, counseling of pregnant women on diet and physical activity recommendations, offering a physical activity program implemented in the participating PHCCs, and adequate referral to dietitians. Women randomly assigned to the CG received routine antenatal care.
RESULTS
At baseline, the mean age was 26.1 y; 45% of women were primipara and 24% were obese. No differences were found in the percentage of women achieving adequate GWG (IG: 30.3%, compared with CG: 31.3%; OR: 0.94; 95% CI: 0.81, 1.09), but women in the IG had lower GWG than those in the CG (11.3 compared with 11.9 kg; mean difference: -0.63 kg; 95% CI: -1.19, -0.08). Effects of the intervention were significantly higher in women with obesity at the begining of pregnancy (mean difference: -1.24 kg; 95% CI: -2.18, -0.30; P for interaction < 0.05). No differences were found between groups regarding maternal glycemic control or neonatal outcomes.
CONCLUSIONS
Our findings demonstrate that a low-intensity, high-coverage intervention delivered through the Chilean public health care system under standard operating conditions reduces GWG and has the potential for successful scale-up. This trial was registered at clinicaltrials.gov as NCT01916603.",2020,"No differences were found between groups regarding maternal glycemic control or neonatal outcomes.
","['4631 pregnant women were recruited (IG, n\xa0=\xa02565; and CG, n\xa0=\xa02066', 'mean age was 26.1 y; 45% of women were primipara and 24% were obese', '12 primary health care centers (PHCCs) from Santiago, Chile', 'Chilean pregnant women on maternal and neonatal outcomes']","['low-intensity and high-coverage nutritional intervention', 'CG received routine antenatal care', 'normative nutrition intervention', '4 key actions: training of health care professionals on nutritional recommendations, counseling of pregnant women on diet and physical activity recommendations, offering a physical activity program implemented in the participating PHCCs, and adequate referral to dietitians', 'nutritional intervention [intervention group (IG), n\xa0=\xa05] or routine care [control group (CG), n\xa0=\xa07']","['gestational weight gain (GWG', 'percentage of women achieving adequate GWG', 'maternal glycemic control or neonatal outcomes', 'adequate GWG and glycemic control in mothers and birth weight, birth length, macrosomia, and large for gestational age in neonates']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008107', 'cui_str': 'Chile'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1276362', 'cui_str': 'Routine antenatal care'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0420347', 'cui_str': 'Patient referral to dietitian'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0419415', 'cui_str': 'Birth length'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]",4631.0,0.127877,"No differences were found between groups regarding maternal glycemic control or neonatal outcomes.
","[{'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Garmendia', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Santiago, Chile.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Corvalan', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Santiago, Chile.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Araya', 'Affiliation': 'Department of Women and Newborn Health Promotion, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Casanello', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Juan Pedro', 'Initials': 'JP', 'LastName': 'Kusanovic', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Uauy', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Santiago, Chile.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa185']
2396,32694002,Science-based communication to decrease disparities in adult pneumococcal vaccination rates.,"OBJECTIVES
The objective of our study was to determine the effects of science-based communications on the attitude toward pneumococcal vaccination and understand how nonwhite racial and ethnic populations respond to these messages.
DESIGN
Our team tested several science-based communications using a nationally representative survey, and validated them in a local community pharmacy as a field experiment.
SETTING AND PARTICIPANTS
The nationally representative sample phase was a survey of 3276 participants, conducted by YouGov, a leading online survey firm. The field experiment was conducted at a community pharmacy in the northeastern United States and included 86 participants.
OUTCOME MEASURES
In the national survey, participants were assigned to treatment groups or a control group to determine the effects of messaging strategies on influencing favorable views of pneumococcal vaccination. In the field experiment, participants were assigned to treatment or control groups to determine if the messaging strategies affected intent to ask a medical professional about the vaccine.
RESULTS
The nationally representative sample survey identified that messaging that focused on community and family duty had statistically significant treatment effects toward increasing individuals' perception of personal importance to have the vaccine in both the nonwhite (increase of 12.2% points relative to control) and white respondents (increase of 8.7% points relative to control). These results were validated through a field experiment, which showed that a combination message, emphasizing duty, increased the individual's intent to vaccinate by 25% points in a diverse ethnic population as compared with the control.
CONCLUSIONS
Messaging focused on appeals to community and family duty produced statistically significant increases in favorable attitudes toward pneumococcal vaccines and behavioral intent to seek medical advice about the vaccine in white and nonwhite populations across both the nationally representative survey and the field experiment. Medical professionals should highlight the duty to family and community when communicating with patients, as it may motivate vaccination in all populations.",2020,"CONCLUSIONS
Messaging focused on appeals to community and family duty produced statistically significant increases in favorable attitudes toward pneumococcal vaccines and behavioral intent to seek medical advice about the vaccine in white and nonwhite populations across both the nationally representative survey and the field experiment.","['The nationally representative sample phase was a survey of 3276 participants, conducted by YouGov, a leading online survey firm', 'community pharmacy in the northeastern United States and included 86 participants']",[],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205233', 'cui_str': 'Firm'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],[],3276.0,0.0262256,"CONCLUSIONS
Messaging focused on appeals to community and family duty produced statistically significant increases in favorable attitudes toward pneumococcal vaccines and behavioral intent to seek medical advice about the vaccine in white and nonwhite populations across both the nationally representative survey and the field experiment.","[{'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Krueger', 'Affiliation': ''}, {'ForeName': 'Marc L', 'Initials': 'ML', 'LastName': 'Hutchison', 'Affiliation': ''}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Bodo', 'Affiliation': ''}, {'ForeName': 'Kelly K', 'Initials': 'KK', 'LastName': 'Orr', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'DeAngelis', 'Affiliation': ''}, {'ForeName': 'Aisling R', 'Initials': 'AR', 'LastName': 'Caffrey', 'Affiliation': ''}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'LaPlante', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2020.05.020']
2397,32702759,Computer-based patient education is non-inferior to nurse counselling prior to colonoscopy: a multicenter randomized controlled trial.,"BACKGROUND
Optimal patient education prior to colonoscopy improves adherence to instructions for bowel preparation and leads to cleaner colons. We developed computer-based education (CBE) supported by video and 3 D animations. We hypothesized that CBE could replace nurse counselling without loss of bowel preparation quality during colonoscopy.
METHODS
We conducted a prospective, multicenter, endoscopist-blinded, non-inferiority randomized controlled trial. The primary outcome was adequate bowel preparation, evaluated using the Boston Bowel Preparation Scale (BBPS). Secondary outcome measures were: sickness absence for outpatient clinic visits; patient anxiety/satisfaction scores; and information recall. We included patients in four endoscopy units (rural, urban, and tertiary).
RESULTS
We screened 1035 eligible patients and randomized 845. After evaluation, 684 were included in the intention-to-treat (ITT) group. Subsequently, 497 patients were included in the per-protocol analysis, 217 in the nurse counselling and 280 in the CBE group. Baseline characteristics were similarly distributed among the groups. On per-protocol analysis, adequate bowel cleansing was achieved in 93.2 % (261/280) of CBE patients, which was non-inferior to nurse-counselled patients (94.0 %; 204/217), with a difference of -0.8 % (95 % confidence interval [CI] -5.1 % to 3.5 %). Non-inferiority was confirmed in the ITT population. Sickness absence was significantly more frequent in nurse-counselled patients (28.0 % vs. 4.8 %). In CBE patients, 21.5 % needed additional information, with 3.0 % needing an extra outpatient visit.
CONCLUSION
CBE is non-inferior to nurse counselling in terms of bowel preparation during colonoscopy, with lower patient sickness leave. CBE may serve as an efficient educational tool to inform patients before colonoscopy in routine clinical practice.",2020,"In PP analysis, adequate bowel cleansing was achieved in 93.2 % (261/280) of CBE patients, which was non-inferior to nurse counselled patients (94%, 204/217), with a difference of -0.8% [95% CI [- 5.1; 3.5]%. Non-inferiority was confirmed in the ITT population.","['1035 eligible patients and randomized 845', 'patients in four endoscopy units (rural, urban, and tertiary', '497 patients were included in per-protocol (PP) analysis, 217 in nurse counselling and 280 in the CBE group']","['CBE', 'Computer based patient education']","['adequate bowel cleansing', 'sickness absence due to outpatient clinic visit, patient anxiety / satisfaction scores and information re-call', 'adequate bowel preparation, evaluated using the Boston Bowel Preparation Scale (BBPS', 'Sickness absence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150375', 'cui_str': 'Group education'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]","[{'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}]",1035.0,0.368664,"In PP analysis, adequate bowel cleansing was achieved in 93.2 % (261/280) of CBE patients, which was non-inferior to nurse counselled patients (94%, 204/217), with a difference of -0.8% [95% CI [- 5.1; 3.5]%. Non-inferiority was confirmed in the ITT population.","[{'ForeName': 'Govert', 'Initials': 'G', 'LastName': 'Veldhuijzen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Klemt-Kropp', 'Affiliation': 'Department of Gastroenterology and Hepatology, Northwest Hospital Group, Alkmaar, The Netherlands.'}, {'ForeName': 'Jochim S', 'Initials': 'JS', 'LastName': 'Terhaar Sive Droste', 'Affiliation': 'Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, Den Bosch, The Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'van Balkom', 'Affiliation': 'Department of Gastroenterology and Hepatology, Bernhoven Hospital, Uden, The Netherlands.'}, {'ForeName': 'Aura A J', 'Initials': 'AAJ', 'LastName': 'van Esch', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Joost P H', 'Initials': 'JPH', 'LastName': 'Drenth', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.'}]",Endoscopy,['10.1055/a-1225-8708']
2398,32690274,Utility of Circulating Tumor Cells for Detection of Early-Stage Luminal A Breast Cancer.,"BACKGROUND
Patients with early-stage luminal A breast cancer (LABC) have better prognoses. However, follow-up examinations are frequent and remain complex. The present study examined whether circulating tumor cell (CTC) detection could be used as an earlier and more reproducible indicator of disease status among patients with early-stage LABC, and given China's healthcare resource challenges, whether it could periodically replace follow-up routine imaging.
METHODS
A total of 135 postoperative Chinese patients with early-stage LABC were randomly assigned to a CTC group (68 patients underwent alternating assessments using CTC detection and routine re-examination) or control group (67 patients underwent only routine re-examination). The prognosis and patient-covered costs of the various assessments were calculated for the 2 groups.
RESULTS
No patients had normal CTCs and simultaneous abnormal imaging findings. There were no differences in overall survival, disease-free survival and total patient-covered cost of follow-up between the 2 groups (all P > 0.05). However, there was a significant difference in the average patient-covered cost (P < 0.001). Furthermore, significant intergroup differences were observed in the total and average hospitalization times (P < 0.05).
CONCLUSIONS
Among Chinese patients with low-risk LABC, CTC detection was highly reliable and relatively low cost. Therefore, CTC detection may be used to reduce the number of routine imaging follow-ups.",2020,"There were no differences in overall survival, disease-free survival and total patient-covered cost of follow-up between the 2 groups (all P > 0.05).","[""patients with early-stage LABC, and given China's healthcare resource challenges"", '135 postoperative Chinese patients with early-stage LABC', 'Chinese patients with low-risk LABC', 'Patients with early-stage luminal A breast cancer (LABC']","['alternating assessments using CTC detection and routine re-examination) or control group (67 patients underwent only routine re-examination', 'CTC', 'Circulating Tumor Cells']","['average patient-covered cost', 'total and average hospitalization times', 'overall survival, disease-free survival and total patient-covered cost of follow']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]","[{'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]",135.0,0.0264389,"There were no differences in overall survival, disease-free survival and total patient-covered cost of follow-up between the 2 groups (all P > 0.05).","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Breast Surgery, Shengjing Hospital of China Medical University, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Qi', 'Affiliation': 'School of Epidemiology, China Medical University, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Jianyi', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Breast Surgery, Shengjing Hospital of China Medical University, Shenyang, Liaoning Province, China. Electronic address: sjbreast@yeah.net.'}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Jia', 'Affiliation': 'Department of Breast Surgery, Shengjing Hospital of China Medical University, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Yitong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Surgery, Shengjing Hospital of China Medical University, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Department of Breast Surgery, General Hospital of Benxi Iron & Steel Industry Group of Liaoning Health Industry Group, Benxi, Liaoning Province, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Department of Pathology, Shengjing Hospital of China Medical University, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Clinical Medicine, China Medical University, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'School of Clinical Medicine, China Medical University, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'School of Clinical Medicine, Jinzhou Medical University, Jinzhou, Liaoning Province, China.'}]",The American journal of the medical sciences,['10.1016/j.amjms.2020.01.020']
2399,32696600,The detrimental effect of COVID-19 nationwide quarantine on accelerometer-assessed physical activity of heart failure patients.,"AIMS
A reduction of habitual physical activity due to prolonged COVID-19 quarantine can have serious consequences for patients with cardiovascular diseases, such as heart failure. This study aimed to explore the effect of COVID-19 nationwide quarantine on accelerometer-assessed physical activity of heart failure patients.
METHODS AND RESULTS
We analysed the daily number of steps in 26 heart failure patients during a 6-week period that included 3 weeks immediately preceding the onset of the quarantine and the first 3 weeks of the quarantine. The daily number of steps was assessed using a wrist-worn accelerometer worn by the patients as part of an ongoing randomized controlled trial. Multilevel modelling was used to explore the effect of the quarantine on the daily step count adjusted for weather conditions. As compared with the 3 weeks before the onset of the quarantine, the step count was significantly lower during each of the first 3 weeks of the quarantine (P < 0.05). When the daily step count was averaged across the 3 weeks before and during the quarantine, the decrease amounted to 1134 (SE 189) steps per day (P < 0.001), which translated to a 16.2% decrease.
CONCLUSIONS
The introduction of the nationwide quarantine due to COVID-19 had a detrimental effect on the level of habitual physical activity in heart failure patients, leading to an abrupt decrease of daily step count that lasted for at least the 3-week study period. Staying active and maintaining sufficient levels of physical activity during the COVID-19 pandemic are essential despite the unfavourable circumstances of quarantine.",2020,"The introduction of the nationwide quarantine due to COVID-19 had a detrimental effect on the level of habitual physical activity in heart failure patients, leading to an abrupt decrease of daily step count that lasted for at least the 3-week study period.","['heart failure patients', 'patients with cardiovascular diseases, such as heart failure', '26 heart failure patients']",['COVID-19 nationwide quarantine'],['habitual physical activity'],"[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0034386', 'cui_str': 'Quarantine'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0344114,"The introduction of the nationwide quarantine due to COVID-19 had a detrimental effect on the level of habitual physical activity in heart failure patients, leading to an abrupt decrease of daily step count that lasted for at least the 3-week study period.","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Vetrovsky', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, José Martího 269/31, Prague, 162 52, Czech Republic.'}, {'ForeName': 'Tereza', 'Initials': 'T', 'LastName': 'Frybova', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Iulian', 'Initials': 'I', 'LastName': 'Gant', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Semerad', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, José Martího 269/31, Prague, 162 52, Czech Republic.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Cimler', 'Affiliation': 'Faculty of Science, University of Hradec Králové, Hradec Králové, Czech Republic.'}, {'ForeName': 'Vaclav', 'Initials': 'V', 'LastName': 'Bunc', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, José Martího 269/31, Prague, 162 52, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Siranec', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Miklikova', 'Affiliation': 'Cardiology Department, University Hospital Brno and Medical Faculty of the Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Vesely', 'Affiliation': 'Faculty of Medicine in Hradec Králové, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Griva', 'Affiliation': 'Department of Cardiology, Tomas Bata Regional Hospital in Zlin, Zlin, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Precek', 'Affiliation': 'Department of Internal Medicine I-Cardiology, University Hospital Olomouc, Olomouc, Czech Republic.'}, {'ForeName': 'Radek', 'Initials': 'R', 'LastName': 'Pelouch', 'Affiliation': '1st Department of Internal Medicine-Cardioangiology, University Hospital Hradec Králové, Hradec Králové, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Parenica', 'Affiliation': 'Cardiology Department, University Hospital Brno and Medical Faculty of the Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Belohlavek', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}]",ESC heart failure,['10.1002/ehf2.12916']
2400,32694343,"Effect of aerobic and resistance exercise training on inflammation, endothelial function and ambulatory blood pressure in middle-aged hypertensive patients.","OBJECTIVE
The current randomized controlled trial tested the hypothesis that both aerobic training and dynamic resistance training will improve inflammation, endothelial function and 24-h ambulatory blood pressure (ABP) in middle-aged adults with hypertension, but aerobic training would be more effective.
METHODS
Forty-two hypertensive patients on at least one antihypertensive medication (19 men/23 women; 30-59 years of age) were randomly assigned to 12 weeks of supervised aerobic training (n = 15), resistance training (n = 15) or a nonexercise control (n = 12) group. Inflammation, endothelial function, 24-h ABP and related measures were evaluated at pre and postintervention.
RESULTS
We found that aerobic training and resistance training were well tolerated. Both aerobic training and resistance training reduced daytime systolic ABP (-7.2 ± 7.9 and -4.4 ± 5.8 mmHg; P < 0.05) and 24-h systolic ABP (-5.6 ± 6.2 and -3.2 ± 6.4 mmHg; P < 0.05). aerobic training and resistance training both improved brachial artery flow-mediated dilation by 1.7 ± 2.8 and 1.4 ± 2.6%, respectively (7.59 ± 3.36 vs. 9.26 ± 2.93 and 7.24 ± 3.18 vs. 8.58 ± 2.37; pre vs. post P < 0.05). However, only aerobic training decreased markers of inflammation (C-reactive protein, monocyte chemoattractant protein-1, vascular cell adhesion molecule-1 and lectin-like oxidized LDL receptor-1) and endothelin-1 and increased nitrite and nitrate levels (P < 0.05).
CONCLUSION
Healthcare providers should continue to emphasize aerobic training for hypertension management given the established role of nitric oxide, endothelin-1 and chronic low-level inflammation in the pathogenesis of cardiovascular disease. However, our study demonstrates that resistance training should also be encouraged for middle-aged hypertensive patients. Our results also suggest that even if patients are on antihypertensive medications, regular aerobic training and resistance training are beneficial for blood pressure control and cardiovascular disease risk reduction.",2020,"However, only aerobic training decreased markers of inflammation (C-reactive protein, monocyte chemoattractant protein-1, vascular cell adhesion molecule-1 and lectin-like oxidized LDL receptor-1) and endothelin-1 and increased nitrite and nitrate levels (P < 0.05).
","['middle-aged adults with hypertension', 'Forty-two hypertensive patients on at least one antihypertensive medication (19 men/23 women; 30-59 years of age', 'middle-aged hypertensive patients']","['aerobic training and dynamic resistance training', 'resistance training', 'supervised aerobic training (n\u200a=\u200a15), resistance training (n\u200a=\u200a15) or a nonexercise control', 'aerobic training and resistance training', 'aerobic and resistance exercise training']","['brachial artery flow-mediated dilation', 'tolerated', 'Inflammation, endothelial function, 24-h ABP and related measures', 'inflammation, endothelial function and 24-h ambulatory blood pressure (ABP', '24-h systolic ABP', 'daytime systolic ABP', 'inflammation, endothelial function and ambulatory blood pressure', 'markers of inflammation (C-reactive protein, monocyte chemoattractant protein-1, vascular cell adhesion molecule-1 and lectin-like oxidized LDL receptor-1) and endothelin-1 and increased nitrite and nitrate levels']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0023206', 'cui_str': 'Lectin'}, {'cui': 'C0034821', 'cui_str': 'LDL receptor'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",42.0,0.0213078,"However, only aerobic training decreased markers of inflammation (C-reactive protein, monocyte chemoattractant protein-1, vascular cell adhesion molecule-1 and lectin-like oxidized LDL receptor-1) and endothelin-1 and increased nitrite and nitrate levels (P < 0.05).
","[{'ForeName': 'Francesco P', 'Initials': 'FP', 'LastName': 'Boeno', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre.'}, {'ForeName': 'Thiago R', 'Initials': 'TR', 'LastName': 'Ramis', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre.'}, {'ForeName': 'Samuel V', 'Initials': 'SV', 'LastName': 'Munhoz', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre.'}, {'ForeName': 'Juliano B', 'Initials': 'JB', 'LastName': 'Farinha', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre.'}, {'ForeName': 'Cesar E J', 'Initials': 'CEJ', 'LastName': 'Moritz', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Leal-Menezes', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre.'}, {'ForeName': 'Jerri L', 'Initials': 'JL', 'LastName': 'Ribeiro', 'Affiliation': 'Centro Universitário Metodista - IPA, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Demetra D', 'Initials': 'DD', 'LastName': 'Christou', 'Affiliation': 'Department of Applied Physiology and Kinesiology, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Reischak-Oliveira', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre.'}]",Journal of hypertension,['10.1097/HJH.0000000000002581']
2401,32701013,Novel serum peptide model revealed by MALDI-TOF-MS and its diagnostic value in early bladder cancer.,"BACKGROUND
Bladder cancer is the ninth most common cancer worldwide and has high morbidity and mortality. We aimed to search for potential serum peptide biomarkers and establish a diagnostic model for early bladder cancer.
METHODS
A total of 67 bladder cancer patients and 64 healthy volunteers were randomly divided into a training set and testing set 1. There were 30 hematuria patients used as testing set 2. Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry based on weak cation exchange magnetic beads was used to obtain and analyze the serum peptide profiles between bladder cancer patients and healthy volunteers in the training set. Serum peptide diagnostic model through a k-nearest neighbor algorithm, was established and validated, and significantly differentially expressed protein biomarkers were ultimately identified.
RESULTS
We constructed a diagnostic model containing five peptides (m/z 1954.9, m/z 2081.0, m/z 3938.3, m/z 3946.5, and m/z 4268.8). In the training set, the area under the curve (AUC) value of the five-peptide model was 0.923, and the sensitivity and specificity was 93.75% and 96.77%, respectively. In testing set 1, the sensitivity and specificity was 91.43% and 90.91%, respectively, and the specificity of testing set 2 was 73.33%. For early-stage bladder cancer, the sensitivity and specificity was 92.31% and 93.75%, respectively; the sensitivity of early low-grade bladder cancer was 90.00%; and the AUC value was 0.944.
CONCLUSION
The five-peptide diagnostic model established in this study had high sensitivity and specificity, especially in the diagnosis of early bladder cancer, and could differentiate between healthy volunteers and hematuria patients.",2020,"The five-peptide diagnostic model established in this study had high sensitivity and specificity, especially in the diagnosis of early bladder cancer, and could differentiate between healthy volunteers and hematuria patients.","['early bladder cancer', 'bladder cancer patients and healthy volunteers', 'healthy volunteers and hematuria patients', '67 bladder cancer patients and 64 healthy volunteers', '30 hematuria patients']",['Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry'],"['sensitivity and specificity', 'Serum peptide diagnostic model', 'sensitivity of early low-grade bladder cancer']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}]","[{'cui': 'C1518101', 'cui_str': 'Matrix-assisted laser desorption/ionisation time-of-flight mass spectrometry'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]",67.0,0.0223575,"The five-peptide diagnostic model established in this study had high sensitivity and specificity, especially in the diagnosis of early bladder cancer, and could differentiate between healthy volunteers and hematuria patients.","[{'ForeName': 'Dapeng', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Department of Clinical Laboratory, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, China.'}, {'ForeName': 'Mingying', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Laboratory, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, China.'}, {'ForeName': 'Xiaoguang', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Clinical Laboratory, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, China.'}, {'ForeName': 'Penglong', 'Initials': 'P', 'LastName': 'Cao', 'Affiliation': 'Department of Clinical Laboratory, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, China.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Laboratory, the First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, China.'}]",The International journal of biological markers,['10.1177/1724600820935473']
2402,32693310,The influence of type of feedback during tablet-based delivery of intensive treatment for childhood apraxia of speech.,"PURPOSE
One of the key principles of motor learning supports using knowledge of results feedback (KR, i.e., whether a response was correct / incorrect only) during high intensity motor practice, rather than knowledge of performance (KP, i.e., whether and how a response was correct/incorrect). In the future, mobile technology equipped with automatic speech recognition (ASR) could provide KR feedback, enabling this practice to move outside the clinic, supplementing speech pathology sessions and reducing burden on already stretched speech-language pathology resources. Here, we employ a randomized controlled trial design to test the impact of KR vs KP feedback on children's response to the Nuffield Dyspraxia Programme 3, delivered through an android tablet. At the time of testing, ASR was not feasible and so correctness of responses was decided by the treating clinician.
METHOD
Fourteen children with CAS, aged 4-10 years, participated in a parallel group design, matched for age and severity of CAS. Both groups attended a university clinic for 1-hr therapy sessions 4 days a week for 3 weeks. One group received high frequency feedback comprised of both KR and KP, in the style of traditional, face-to-face intensive intervention on all days. The other group received high frequency KR + KP feedback on 1 day per week and high frequency KR feedback on the other 3 days per week, simulating the service delivery model of one clinic session per week supported by tablet-based home practice.
RESULTS
Both groups had significantly improved speech outcomes at 4-months post-treatment. Post-hoc comparisons suggested that only the KP group showed a significant change from pre- to immediately post-treatment but the group difference had dissipated by 1-month post-treatment. Heterogeneity in response to intervention within the groups suggests that other factors, not measured here, may be having a substantive influence on response to intervention and feedback type.
CONCLUSION
Mobile technology has the potential to increase motivation and engagement with therapy and to mitigate barriers associated with distance and access to speech pathology services. Further research is needed to explore the influence of type and frequency of feedback on motor learning, optimal timing for transitioning from KP to KR feedback, and how these parameters interact with task, child and context-related factors.",2020,Post-hoc comparisons suggested that only the KP group showed a significant change from pre- to immediately post-treatment but the group difference had dissipated by 1-month post-treatment.,"['childhood apraxia of speech', 'Fourteen children with CAS, aged 4-10 years, participated in a parallel group design, matched for age and severity of CAS']","['KR vs KP feedback', 'mobile technology equipped with automatic speech recognition (ASR', 'high frequency KR + KP feedback', 'high frequency feedback comprised of both KR and KP']",['speech outcomes'],"[{'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",14.0,0.0201653,Post-hoc comparisons suggested that only the KP group showed a significant change from pre- to immediately post-treatment but the group difference had dissipated by 1-month post-treatment.,"[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'McKechnie', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia; Faculty of Health, University of Canberra, Bruce, ACT, Australia. Electronic address: Jacqui.McKechnie@canberra.edu.au.'}, {'ForeName': 'Beena', 'Initials': 'B', 'LastName': 'Ahmed', 'Affiliation': 'Texas A&M University at Qatar, Doha, Qatar; Faculty of Engineering, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gutierrez-Osuna', 'Affiliation': 'Texas A & M University, College Station, TX, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Murray', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'McCabe', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Kirrie J', 'Initials': 'KJ', 'LastName': 'Ballard', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106026']
2403,32698812,Protocol: examining the effectiveness of an adaptive implementation intervention to improve uptake of the VA suicide risk identification strategy: a sequential multiple assignment randomized trial.,"BACKGROUND
In 2018, the Veterans Health Administration (VHA) mandated implementation of a national suicide risk identification strategy (Risk ID). The goal of Risk ID is to improve the detection and management of suicide risk by standardizing suicide risk screening and evaluation enterprise-wide. In order to ensure continuous quality improvement (QI), ongoing evaluation and targeted interventions to improve implementation of Risk ID are needed. Moreover, given that facilities will vary with respect to implementation needs and barriers, the dose and type of intervention needed may vary across facilities. Thus, the objective of this study is to examine the effectiveness of an adaptive implementation strategy to improve the uptake of suicide risk screening and evaluation in VHA ambulatory care settings. In addition, this study will examine specific factors that may impact the uptake of suicide risk screening and evaluation and the adoption of different implementation strategies. This protocol describes the stepped implementation approach and proposed evaluation plan.
METHODS
Using a sequential multiple assignment randomized trial (SMART) design, two evidence-based implementation strategies will be evaluated: (1) audit and feedback (A&F); (2) A&F plus external facilitation (A&F + EF). Implementation outcomes of interest include uptake of secondary suicide risk screening and uptake of comprehensive suicide risk evaluation (stages 2 and 3 of Risk ID). Secondary outcomes include rates of other clinical outcomes (i.e., safety planning) and organizational factors that may impact Risk ID implementation (i.e., leadership climate and leadership support).
DISCUSSION
This national QI study will use a SMART design to evaluate whether an adaptive implementation strategy is effective in improving uptake of a mandated VHA-wide suicide risk screening and evaluation initiative. If this study finds that the proposed stepped implementation strategy is effective at increasing uptake and maintaining performance improvements, this approach may be used as an overarching QI strategy for other national suicide prevention programs.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04243330 . Registered 28 January 2020.",2020,"If this study finds that the proposed stepped implementation strategy is effective at increasing uptake and maintaining performance improvements, this approach may be used as an overarching QI strategy for other national suicide prevention programs.
",[],"['adaptive implementation intervention', 'feedback (A&F); (2) A&F plus external facilitation (A&F + EF']","['rates of other clinical outcomes (i.e., safety planning) and organizational factors that may impact Risk ID implementation (i.e., leadership climate and leadership support']",[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0150323', 'cui_str': 'Risk identification'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",,0.112886,"If this study finds that the proposed stepped implementation strategy is effective at increasing uptake and maintaining performance improvements, this approach may be used as an overarching QI strategy for other national suicide prevention programs.
","[{'ForeName': 'Nazanin H', 'Initials': 'NH', 'LastName': 'Bahraini', 'Affiliation': 'VA Rocky Mountain Mental Illness Research, Education and Clinical Center (MIRECC), Rocky Mountain Regional VA Medical Center, 1700 N Wheeling St, Aurora, CO, 80045, USA. nazanin.bahraini@va.gov.'}, {'ForeName': 'Bridget B', 'Initials': 'BB', 'LastName': 'Matarazzo', 'Affiliation': 'VA Rocky Mountain Mental Illness Research, Education and Clinical Center (MIRECC), Rocky Mountain Regional VA Medical Center, 1700 N Wheeling St, Aurora, CO, 80045, USA.'}, {'ForeName': 'Catherine N', 'Initials': 'CN', 'LastName': 'Barry', 'Affiliation': 'VA Program Evaluation and Resource Center (PERC), Palo Alto, CA, USA.'}, {'ForeName': 'Edward P', 'Initials': 'EP', 'LastName': 'Post', 'Affiliation': 'Ann Arbor VA Health Care System, Ann Arbor, MI, USA.'}, {'ForeName': 'Jeri E', 'Initials': 'JE', 'LastName': 'Forster', 'Affiliation': 'VA Rocky Mountain Mental Illness Research, Education and Clinical Center (MIRECC), Rocky Mountain Regional VA Medical Center, 1700 N Wheeling St, Aurora, CO, 80045, USA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Dollar', 'Affiliation': 'VA Center for Integrated Healthcare, Syracuse, NY, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Dobscha', 'Affiliation': 'VA Center to Improve Veteran Involvement in Care, Portland VA Health Care System, Portland, OR, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Brenner', 'Affiliation': 'VA Rocky Mountain Mental Illness Research, Education and Clinical Center (MIRECC), Rocky Mountain Regional VA Medical Center, 1700 N Wheeling St, Aurora, CO, 80045, USA.'}]",Implementation science : IS,['10.1186/s13012-020-01019-6']
2404,32701144,Comparison of 3 Devices for 24-Hour Ambulatory Blood Pressure Monitoring in a Nonclinical Environment Through a Randomized Trial.,"BACKGROUND
The U.S. Preventive Services Task Force recommends the use of 24-hour ambulatory blood pressure monitoring (ABPM) as part of screening and diagnosis of hypertension. The optimal ABPM device for population-based surveys is unknown.
METHODS
We compared the proportion of valid blood pressure (BP) readings, mean awake and asleep BP readings, differences between awake ABPM readings and initial standardized BP readings, and sleep experience among three ABPM devices. We randomized a convenience sample of 365 adults to 1 of 3 ABPM devices: Welch Allyn Mobil-O-Graph (WA), Sun Tech Classic Oscar2 (STO) and Spacelabs 90227 (SL). Participants completed sleep quality questionnaires on the nights before and during ABPM testing.
RESULTS
The proportions of valid BP readings were not different among the 3 devices (P > 0.45). Mean awake and asleep systolic BP were significantly higher for STO device (WA vs. STO vs. SL: 126.65, 138.09, 127.44 mm Hg; 114.34, 120.34, 113.13 mm Hg; P < 0.0001 for both). The difference between the initial average standardized mercury systolic BP readings and the ABPM mean awake systolic BP was larger for STO device (WA vs. STO. vs. SL: -5.26, -16.24, -5.36 mm Hg; P < 0.0001); diastolic BP mean differences were ~ -6 mm Hg for all 3 devices (P = 0.6). Approximately 55% of participants reported that the devices interfered with sleep; however, there were no sleep differences across the devices (P > 0.4 for all).
CONCLUSION
Most of the participants met the threshold of 70% valid readings over 24 hours. Sleep disturbance was common but did not interfere with completion of measurement in most of the participants.",2020,The proportions of valid blood pressure readings were not different among the three devices ( p > 0.45).,[],"['24-hour ambulatory blood pressure monitoring (ABPM', 'SL']","['proportions of valid blood pressure readings', 'proportion of valid BP readings, mean awake and asleep BP readings, differences between awake ABPM readings and initial standardized BP readings, and sleep experience', 'Mean awake and asleep systolic BP', 'initial average standardized mercury systolic BP readings and the ABPM mean awake systolic BP', 'Sleep disturbance', 'diastolic BP mean differences']",[],"[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0025424', 'cui_str': 'Mercury'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.0996408,The proportions of valid blood pressure readings were not different among the three devices ( p > 0.45).,"[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Nwankwo', 'Affiliation': 'Division of Health and Nutrition Examination Surveys, National Center for Health Statistics, CDC, Hyattsville, Maryland, USA.'}, {'ForeName': 'Sallyann M', 'Initials': 'SM', 'LastName': 'Coleman King', 'Affiliation': 'Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia, USA.'}, {'ForeName': 'Yechiam', 'Initials': 'Y', 'LastName': 'Ostchega', 'Affiliation': 'Division of Health and Nutrition Examination Surveys, National Center for Health Statistics, CDC, Hyattsville, Maryland, USA.'}, {'ForeName': 'Guangyu', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Division of Research and Methodology, National Center for Health Statistics, CDC, Hyattsville, Maryland, USA.'}, {'ForeName': 'Fleetwood', 'Initials': 'F', 'LastName': 'Loustalot', 'Affiliation': 'Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia, USA.'}, {'ForeName': 'Cathleen', 'Initials': 'C', 'LastName': 'Gillespie', 'Affiliation': 'Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia, USA.'}, {'ForeName': 'Tiffany E', 'Initials': 'TE', 'LastName': 'Chang', 'Affiliation': 'Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia, USA.'}, {'ForeName': 'Elin B', 'Initials': 'EB', 'LastName': 'Begley', 'Affiliation': 'Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia, USA.'}, {'ForeName': 'Mary G', 'Initials': 'MG', 'LastName': 'George', 'Affiliation': 'Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia, USA.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'Department of Medicine, Center for Behavioral Cardiovascular Health, Columbia University, Medical Center, New York, New York, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Schwartz', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Applied Behavioral Medicine Research Institute, Stony Brook University, Stony Brook, New York, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Kronish', 'Affiliation': 'Department of Medicine, Center for Behavioral Cardiovascular Health, Columbia University, Medical Center, New York, New York, USA.'}, {'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Merritt', 'Affiliation': 'Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia, USA.'}]",American journal of hypertension,['10.1093/ajh/hpaa117']
2405,32693116,Topical therapy with rhubarb navel plasters in patients with chronic constipation: Results from a prospective randomized multicenter study.,"ETHNOPHARMACOLOGICAL RELEVANCE
Constipation is a functional gastrointestinal disorder and one of the most prevalent conditions encountered in primary care settings. Rhubarb navel dressings have been used for more than 2,000 years in Chinese medicine to treat constipation. However, the effect of topical rhubarb administration has still not been well recognized and this strategy is not yet established as an evidence-based approach.
AIM OF THE STUDY
In this study, we performed a prospective multicentric randomized controlled trial to evaluate the efficacy and safety of rhubarb navel plasters for patients with chronic constipation.
MATERIALS AND METHODS
A total of 374 patients from six teaching hospitals were prospectively included between 09/2016 and 10/2017 in the study based on Rome III criteria. All participants were randomly assigned (1:1) into verum/placebo group and given either Rheum officinale rhubarb powder or a placebo flour stick on the navel for 6 h/day/8 days. Primary outcome measures were the Cleveland Constipation Score (CCS) for the feces condition and Bristol Stool Scale (BSS) for stool consistency and 24 h defecation frequency.
RESULTS
The groups demonstrated no statistical differences in demographic data, clinical diagnoses and concomitant medication at baseline. In patients treated with the verum CCS was 5.61 (day 8, 95% CI 5.15-6.07) compared to 8.62 (95% CI 8.07-9.18) in placebo-treated controls (P < 0.001). The mean change of CCS at the end of treatment (day 8 versus [vs] day 0) was 6.04 in verum-treated vs 2.73 in placebo-treated controls (P < 0.001). Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05). No significant differences in adverse events between both groups became obvious.
CONCLUSION
Rhubarb navel plaster administration over an 8-day-treatment period resulted in significantly improved bowel function as demonstrated by the CCS, 24 h defecating frequency and BSS. Our results suggest that rhubarb navel plasters represent a feasible, safe and efficient application route for the treatment of patients suffering from chronic constipation.",2021,"Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05).","['patients with chronic constipation', 'patients suffering from chronic constipation', '374 patients from six teaching hospitals were prospectively included between 09/2016 and 10/2017 in the study based on Rome III criteria']","['verum/placebo group and given either Rheum officinale rhubarb powder or a placebo flour stick', 'Rhubarb navel dressings', 'Topical therapy', 'rhubarb navel plasters', 'verum CCS']","['demographic data, clinical diagnoses and concomitant medication', 'bowel function', 'BSS type classification', 'efficacy and safety', 'adverse events', 'defecation frequency (BSS', 'Cleveland Constipation Score (CCS) for the feces condition and Bristol Stool Scale (BSS) for stool consistency and 24\u202fh defecation frequency', 'mean change of CCS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0035509', 'cui_str': 'Rhubarb'}, {'cui': 'C1815861', 'cui_str': 'Rhubarb powder'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0457570', 'cui_str': 'Scale type'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",374.0,0.207116,"Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05).","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: weilin22@126.com.'}, {'ForeName': 'Yueming', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'The fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China. Electronic address: 314851488@qq.com.'}, {'ForeName': 'Xiaopei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: xingyunxing021@163.com.'}, {'ForeName': 'Yangchen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: morning924@126.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gasser', 'Affiliation': 'University of Wuerzburg, Wuerzburg, Germany. Electronic address: gasser_m@t-online.de.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: tangtang56love@126.com.'}, {'ForeName': 'Wen-Wei', 'Initials': 'WW', 'LastName': 'Ouyang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: yudexin1984@163.com.'}, {'ForeName': 'Hengqiu', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Electronic address: 1131968978@qq.com.'}, {'ForeName': 'Shengzhen', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Jiangxi Integrated Traditional Chinese and Western Medicine Hospital, Nanchang, China. Electronic address: 982121880@qq.com.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Nanchang, China. Electronic address: 64243156@qq.com.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Waaga-Gasser', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: awaaga@bwh.harvard.edu.""}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Guangzhou University of Traditional Chinese Medicine, Guangzhou, China. Electronic address: gzdtcm@gzucm.edu.cn.'}, {'ForeName': 'Meizhen', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: linmeizhen@gzucm.edu.cn.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113096']
2406,32694454,Comprehensive Cardiac Rehabilitation Effectiveness in a Middle-Income Setting: A RANDOMIZED CONTROLLED TRIAL.,"PURPOSE
The impact of comprehensive cardiac rehabilitation (CCR) in Latin America is not well known. Herein, the pre-specified tertiary outcomes of a cardiac rehabilitation (CR) trial are reported: disease-related knowledge, depressive symptoms, and heart-health behaviors (exercise, diet, and smoking).
METHODS
This was a single-blinded, single-center (Brazil) randomized trial with three parallel arms: CCR (exercise + education) versus exercise-only CR versus wait-list control. Eligible patients were randomized in blocks of four with 1:1:1 concealed allocation. The CR program was 6 mo long. Participants randomized to exercise-only CR received 36 exercise classes; the CCR group also received 24 educational sessions, including a workbook. All outcomes were assessed at pre-test and 6-mo later (blinded). Analysis of covariance was performed by intention-to-treat (ITT) and per-protocol (PP).
RESULTS
A total of 115 (89%) patients were randomized; 93 (81%) were retained. There were significant improvements in knowledge with CCR (ITT [51.2 ± 11.9 pre and 60.8 ± 13.2 post] and PP; P < .01), with significantly greater knowledge with CCR versus control (ITT mean difference [MD] = 9.5, 95% CI, 2.3-16.8) and CCR vs exercise-only CR at post-test (ITT MD = 6.8, 95% CI, 0.3-14.0). There were also significant improvements in self-reported exercise with CCR (ITT [13.7 ± 15.8 pre and 32.1 ± 2 5.7 post] and PP; P < .001), with significantly greater exercise with CCR versus control at post-test (ITT MD = 7.6, 95% CI, 3.8-11.4). Also, there were significant improvements in diet with CCR (PP: 3.4 ± 7.5 pre and 8.0 ± 7.0 post; P < .05).
CONCLUSIONS
In this first-ever randomized trial of CR for coronary artery disease in Latin America, the benefits of CCR have been supported.",2020,"There were also significant improvements in self-reported exercise with CCR (ITT [13.7 ± 15.8 pre and 32.1 ± 2 5.7 post] and PP; P < .001), with significantly greater exercise with CCR versus control at post-test (ITT MD = 7.6, 95% CI, 3.8-11.4).","['Middle-Income Setting', 'A total of 115 (89%) patients were randomized; 93 (81%) were retained', 'Eligible patients']","['comprehensive cardiac rehabilitation (CCR', 'exercise-only CR received 36 exercise classes; the CCR group also received 24 educational sessions', 'CR', 'CCR (exercise + education) versus exercise-only CR versus wait-list control']","['self-reported exercise with CCR', 'knowledge with CCR']","[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333118', 'cui_str': 'Retained'}]","[{'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0454306', 'cui_str': 'Exercise class'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",115.0,0.282397,"There were also significant improvements in self-reported exercise with CCR (ITT [13.7 ± 15.8 pre and 32.1 ± 2 5.7 post] and PP; P < .001), with significantly greater exercise with CCR versus control at post-test (ITT MD = 7.6, 95% CI, 3.8-11.4).","[{'ForeName': 'Gabriela Lima de Melo', 'Initials': 'GLM', 'LastName': 'Ghisi', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation Program, Toronto Rehabilitation Institute, University Health Network, University of Toronto, Ontario, Canada (Drs Ghisi, Oh, and Dr Grace); Physical Therapy Department, Federal University of Minas Gerais, Minas Gerais, Brazil (Drs Chaves and Britto); School of Kinesiology and Health Science, York University, Toronto, Ontario, Canada (Drs Chaves and Grace); and University Hospital, Division of Cardiology and Cardiovascular Surgery, Federal University of Minas Gerais, Minas Gerais, Brazil (Dr Ribeiro).'}, {'ForeName': 'Gabriela S S', 'Initials': 'GSS', 'LastName': 'Chaves', 'Affiliation': ''}, {'ForeName': 'Antonio L', 'Initials': 'AL', 'LastName': 'Ribeiro', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Oh', 'Affiliation': ''}, {'ForeName': 'Raquel R', 'Initials': 'RR', 'LastName': 'Britto', 'Affiliation': ''}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'Grace', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000512']
2407,32697957,"Effects of long-term concurrent training to failure or not in muscle power output, muscle quality and cardiometabolic risk factors in older men: A secondary analysis of a randomized clinical trial.","This study investigated the effects of concurrent training performed either with repetitions to failure or not to failure in muscle power, muscle quality (MQ), peak oxygen uptake (VO 2peak ), and visceral fat in older men. This is an ancillary analysis of a randomized controlled trial. 36 older men (mean age ± SD; 67.1 ± 5.1 years) were randomized into three groups: one performing repetitions to failure (RFG, n = 13), another performing repetitions not to failure and 50% of the repetitions of the RFG (NFG, n = 12), and third performing repetitions not to failure with equal training volume of the RFG (ENFG, n = 11). The training was performed twice a week for 20 weeks at intensities ranging from 65 to 80% of maximal strength. In each session, the individuals started with strengthening exercises and then performed aerobic exercise (i.e., walking) on a treadmill. The primary endpoint was change from baseline to post-20 wk of absolute and relative muscle power output during squat and countermovement jump, ultrasound measurements for MQ using quadriceps echo intensity, and visceral fat thickness, as well as their VO 2peak through a maximal incremental test on a treadmill. All training groups improved similarly and significantly jump height (ranging from 9 to 16%) and all their muscle power outcomes (mean change ranging from 2 to 7%) (P < .001). In addition, all groups significantly decreased visceral fat thickness (ranging from -11 to -21%) (P < .001), and significantly increased VO 2peak (ranging from 4 to 8%) (P < .01), with no differences between groups. No changes were observed in the MQ outcomes. Concurrent training performed using repetitions to failure or not to failure promoted similar gains in the muscle power output, aerobic capacity, and visceral fat in healthy older men.",2020,All training groups improved similarly and significantly jump height (ranging from 9 to 16%) and all their muscle power outcomes (mean change ranging from 2 to 7%) (P < .001).,"['36 older men (mean age\u202f±\u202fSD; 67.1\u202f±\u202f5.1\u202fyears', 'healthy older men', 'older men']","['another performing repetitions not to failure and 50% of the repetitions of the RFG (NFG, n\u202f=\u202f12), and third performing repetitions not to failure with equal training volume of the RFG (ENFG, n', 'strengthening exercises and then performed aerobic exercise (i.e., walking) on a treadmill']","['VO 2peak', 'visceral fat thickness', 'MQ outcomes', 'muscle power output, muscle quality and cardiometabolic risk factors', 'change from baseline to post-20\u202fwk of absolute and relative muscle power output during squat and countermovement jump, ultrasound measurements for MQ using quadriceps echo intensity, and visceral fat thickness, as well as their VO 2peak through a maximal incremental test on a treadmill', 'jump height', 'muscle power, muscle quality (MQ), peak oxygen uptake (VO 2peak ), and visceral fat']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",36.0,0.0273081,All training groups improved similarly and significantly jump height (ranging from 9 to 16%) and all their muscle power outcomes (mean change ranging from 2 to 7%) (P < .001).,"[{'ForeName': 'Juliana L', 'Initials': 'JL', 'LastName': 'Teodoro', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Larissa X N', 'Initials': 'LXN', 'LastName': 'da Silva', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Bruno M', 'Initials': 'BM', 'LastName': 'Baroni', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Grazioli', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Carolina G', 'Initials': 'CG', 'LastName': 'Fritsch', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Régis', 'Initials': 'R', 'LastName': 'Radaelli', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Saez de Asteasu', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil; Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Martim', 'Initials': 'M', 'LastName': 'Bottaro', 'Affiliation': 'College of Physical Education, University of Brasilia, Brasília, DF, Brazil.'}, {'ForeName': 'Juliano Boufleur', 'Initials': 'JB', 'LastName': 'Farinha', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ronei S', 'Initials': 'RS', 'LastName': 'Pinto', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Cadore', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil. Electronic address: edu.cadore@ufrgs.br.'}]",Experimental gerontology,['10.1016/j.exger.2020.111023']
2408,32701928,"Volume and effectiveness assessment of articain 4% versus mepivacaine 2% used in third molar surgery: randomized, double-blind, split-mouth controlled clinical trial.","BACKGROUND
The different indications for extraction of the lower third molars, require resources to manage pain and discomfort, such as, for example, adequate anesthetic techniques, and the type of anesthetic used can influence the management of pain in tooth extractions. Few studies in the literature compare the anesthetics 4% articaine hydrochloride and 2% mepivacaine hydrochloride showing evidence that both allow for successful pain management. This study sought to compare the volume, efficacy and safety of these two anesthetic drugs, both associated with epinephrine at a ratio of 1:100,000, used in the extraction of lower third molars.
MATERIAL AND METHODS
A controlled, clinical, split-mouth compared these both local anesthetics in a sample of 20 patients requiring bilateral extraction of teeth. Pain was the main parameter to be assessed by means of the visual analogue scale (VAS) applied during and immediately after the surgery. Hemodynamic parameters, adverse events, presence of paresthesia and satisfaction of patients and surgeon were also analysed.
RESULTS
Pain management was more effective with mepivacaine up to two hours after surgery (p=0.014), whereas the surgeon was more satisfied with the use of articaine during divulsion and suture (p<0.05). However no statistically significant differences were found between both anesthetics regarding pain perception.
CONCLUSIONS
It was observed that both anesthetics are efficient and safe in the management of pain for extraction of third molars, in which less amount of mepivacaine is needed. The satisfaction of patients and surgeon was the same for both anesthetics, with articaine being highlighted during divulsion and suture.",2020,"It was observed that both anesthetics are efficient and safe in the management of pain for extraction of third molars, in which less amount of mepivacaine is needed.",['20 patients requiring bilateral extraction of teeth'],"['mepivacaine hydrochloride', 'local anesthetics', 'articaine', 'articaine hydrochloride', 'epinephrine', 'mepivacaine']","['visual analogue scale (VAS', 'Pain', 'Hemodynamic parameters, adverse events, presence of paresthesia and satisfaction of patients and surgeon', 'volume, efficacy and safety', 'pain perception']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0700542', 'cui_str': 'Mepivacaine hydrochloride'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0007300', 'cui_str': 'Articaine hydrochloride'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",20.0,0.145288,"It was observed that both anesthetics are efficient and safe in the management of pain for extraction of third molars, in which less amount of mepivacaine is needed.","[{'ForeName': 'P-C', 'Initials': 'PC', 'LastName': 'Almeida', 'Affiliation': 'Cale Francisco José Longo Avenue, 777 Jardim São Dimas, São José dos Campos SP, Brazil, 12245 -000 paulacarolinasj@yahoo.com.br.'}, {'ForeName': 'F-V', 'Initials': 'FV', 'LastName': 'Raldi', 'Affiliation': ''}, {'ForeName': 'F-R', 'Initials': 'FR', 'LastName': 'Sato', 'Affiliation': ''}, {'ForeName': 'R-D', 'Initials': 'RD', 'LastName': 'Nascimento', 'Affiliation': ''}, {'ForeName': 'M-B', 'Initials': 'MB', 'LastName': 'Moraes', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23780']
2409,32701929,Leukocyte- and platelet-rich fibrin does not provide any additional benefit for tooth extraction in head and neck cancer patients post-radiotherapy: a randomized clinical trial.,"BACKGROUND
One of the most important complications of radiotherapy (RT) for head and neck cancer (HNC) is osteoradionecrosis (ORN) of the jaws, arising mainly from tooth extractions. Thus, the present study aimed to evaluate the efficacy of leukocyte- and platelet-rich fibrin (L-PRF) in preventing ORN following tooth extraction in post-irradiated HNC patients, as well as other postoperative complications.
MATERIAL AND METHODS
23 patients previously submitted to conventionally fractionated 3D-conformational RT for HNC underwent atraumatic tooth extractions with perioperative antibiotic therapy. Besides, they were randomly assigned to receive L-PRF clots to fill and cover the extraction sockets (n=11, Test Group) or not (n=12, Control Group). A visual analog scale was used to quantify postoperative pain on the 3rd and 7th days. For ORN diagnosis, patients were clinically assessed for up to 180 days. Other postoperative complications (edema, alveolitis, suture dehiscence, continuous bleeding, and oroantral communication) were also evaluated within this period.
RESULTS
No case of ORN or another surgical complication was observed and there were no differences in the postoperative pain scores between the groups on the 3rd and 7th days.
CONCLUSIONS
L-PRF did not seem to provide any additional benefits than those achieved by the combination of the surgical and drug protocols used for tooth extractions in the post-irradiated HNC patients.",2020,"No case of ORN or another surgical complication was observed and there were no differences in the postoperative pain scores between the groups on the 3rd and 7th days.
","['head and neck cancer patients post', '23 patients previously submitted to conventionally fractionated 3D-conformational RT for HNC underwent atraumatic tooth extractions with perioperative antibiotic therapy']","['radiotherapy', 'radiotherapy (RT', 'leukocyte- and platelet-rich fibrin (L-PRF', 'L-PRF clots to fill and cover the extraction sockets', 'Leukocyte- and platelet-rich fibrin']","['ORN or another surgical complication', 'postoperative complications (edema, alveolitis, suture dehiscence, continuous bleeding, and oroantral communication', 'postoperative pain scores']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}]","[{'cui': 'C0029461', 'cui_str': 'Osteoradionecrosis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0549493', 'cui_str': 'Alveolitis'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0029293', 'cui_str': 'Oroantral fistula'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",23.0,0.0349457,"No case of ORN or another surgical complication was observed and there were no differences in the postoperative pain scores between the groups on the 3rd and 7th days.
","[{'ForeName': 'L-F', 'Initials': 'LF', 'LastName': 'Palma', 'Affiliation': 'Rua da Moóca, 2518 cj13. 03104-002 São Paulo, SP, Brazil leandro_chambrone@hotmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marcucci', 'Affiliation': ''}, {'ForeName': 'C-M', 'Initials': 'CM', 'LastName': 'Remondes', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Chambrone', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23804']
2410,32704386,"Erratum: Author Correction: Antibody responses to the RTS,S/AS01 E vaccine and Plasmodium falciparum antigens after a booster dose within the phase 3 trial in Mozambique.",[This corrects the article DOI: 10.1038/s41541-020-0192-7.].,2020,[This corrects the article DOI: 10.1038/s41541-020-0192-7.].,['Erratum'],[],[],[],[],[],,0.0161305,[This corrects the article DOI: 10.1038/s41541-020-0192-7.].,"[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Sánchez', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Vidal', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'Chenjerai', 'Initials': 'C', 'LastName': 'Jairoce', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Aguilar', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Ubillos', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'Inocencia', 'Initials': 'I', 'LastName': 'Cuamba', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.'}, {'ForeName': 'Augusto J', 'Initials': 'AJ', 'LastName': 'Nhabomba', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.'}, {'ForeName': 'Nana Aba', 'Initials': 'NA', 'LastName': 'Williams', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Díez-Padrisa', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cavanagh', 'Affiliation': ""Institute of Immunology & Infection Research and Centre for Immunity, Infection & Evolution, Ashworth Laboratories, School of Biological Sciences, University of Edinburgh, King's Buildings, Edinburgh, UK.""}, {'ForeName': 'Evelina', 'Initials': 'E', 'LastName': 'Angov', 'Affiliation': 'U.S. Military Malaria Vaccine Program, Walter Reed Army Institute of Research (WRAIR), Silver Spring, MD USA.'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Coppel', 'Affiliation': 'Infection and Immunity Program, Monash Biomedicine Discovery Institute and Department of Microbiology, Monash University, Melbourne, VIC Australia.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Gaur', 'Affiliation': 'Malaria Group, International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi, India.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Beeson', 'Affiliation': 'Burnet Institute, Melbourne, VIC Australia.'}, {'ForeName': 'Sheetij', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'U.S. Military Malaria Vaccine Program, Walter Reed Army Institute of Research (WRAIR), Silver Spring, MD USA.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Aide', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Campo', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Moncunill', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Dobaño', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}]",NPJ vaccines,['10.1038/s41541-020-00213-3']
2411,32701512,Pharmacogenomics of aromatase inhibitors in postmenopausal breast cancer and additional mechanisms of anastrozole action.,"Aromatase inhibitors (AIs) reduce breast cancer recurrence and prolong survival, but up to 30% of patients exhibit recurrence. Using a genome-wide association study of patients entered on MA.27, a phase III randomized trial of anastrozole versus exemestane, we identified a single nucleotide polymorphism (SNP) in CUB And Sushi multiple domains 1 (CSMD1) associated with breast cancer-free interval, with the variant allele associated with fewer distant recurrences. Mechanistically, CSMD1 regulates CYP19 expression in an SNP- and drug-dependent fashion, and this regulation is different among 3 AIs: anastrozole, exemestane, and letrozole. Overexpression of CSMD1 sensitized AI-resistant cells to anastrozole but not to the other 2 AIs. The SNP in CSMD1 that was associated with increased CSMD1 and CYP19 expression levels increased anastrozole sensitivity, but not letrozole or exemestane sensitivity. Anastrozole degrades estrogen receptor α (ERα), especially in the presence of estradiol (E2). ER+ breast cancer organoids and AI- or fulvestrant-resistant breast cancer cells were more sensitive to anastrozole plus E2 than to AI alone. Our findings suggest that the CSMD1 SNP might help to predict AI response, and anastrozole plus E2 serves as a potential new therapeutic strategy for patients with AI- or fulvestrant-resistant breast cancers.",2020,ER positive breast cancer organoids and AI- or fulvestrant-resistant breast cancer cells were more sensitive to anastrozole plus E2 than to AI alone.,"['postmenopausal breast cancer', 'patients with AI- or fulvestrant-resistant breast cancers']","['CSMD1 SNP', 'anastrozole', 'anastrozole, exemestane, and letrozole', 'anastrozole vs exemestane', 'Anastrozole', 'aromatase inhibitors']","['Aromatase inhibitors (AIs) reduce breast cancer recurrence and prolong survival', 'CSMD1 and CYP19 expression levels increased anastrozole sensitivity']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0010435', 'cui_str': 'Cuba'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}]","[{'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0010435', 'cui_str': 'Cuba'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0003805', 'cui_str': 'Androstenedione Aromatase'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0242212,ER positive breast cancer organoids and AI- or fulvestrant-resistant breast cancer cells were more sensitive to anastrozole plus E2 than to AI alone.,"[{'ForeName': 'Junmei', 'Initials': 'J', 'LastName': 'Cairns', 'Affiliation': 'Department of Molecular Pharmacology and Experimental Therapeutics.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Ingle', 'Affiliation': 'Division of Medical Oncology, and.'}, {'ForeName': 'Tanda M', 'Initials': 'TM', 'LastName': 'Dudenkov', 'Affiliation': 'Department of Molecular Pharmacology and Experimental Therapeutics.'}, {'ForeName': 'Krishna R', 'Initials': 'KR', 'LastName': 'Kalari', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Carlson', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Na', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Aman U', 'Initials': 'AU', 'LastName': 'Buzdar', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Robson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Ellis', 'Affiliation': 'Baylor Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Goss', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Lois E', 'Initials': 'LE', 'LastName': 'Shepherd', 'Affiliation': 'NCIC Clinical Trials Group, Kingston, Ontario, Canada.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Goodnature', 'Affiliation': 'Patient advocate, Mayo Clinic Breast Cancer Specialized Program of Research Excellence, Rochester, Minnesota, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Division of Medical Oncology, and.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Weinshilboum', 'Affiliation': 'Department of Molecular Pharmacology and Experimental Therapeutics.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Molecular Pharmacology and Experimental Therapeutics.'}, {'ForeName': 'Mehrab Ghanat', 'Initials': 'MG', 'LastName': 'Bari', 'Affiliation': 'Department of Molecular Pharmacology and Experimental Therapeutics.'}, {'ForeName': 'Liewei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Molecular Pharmacology and Experimental Therapeutics.'}]",JCI insight,['10.1172/jci.insight.137571']
2412,32701564,Cardiac baroreflex function and vascular reactivity recovery after aerobic exercise in patients with early cirrhosis.,"OBJECTIVE
To investigate the effects of aerobic exercise on the cardiac baroreflex function and vascular reactivity in patients with cirrhosis.
METHODS
Thirteen patients with cirrhosis were submitted to exercise and control intervention. At baseline and at 30 and 60 min following intervention, we evaluated cardiac baroreflex sensitivity (cBRS) and the baroreflex effectiveness index (BEI) using sequence technique. Vascular reactivity was assessed inducing reactive hyperemia before and 60 min after intervention.
RESULTS
At baseline, there was no difference (P interaction = 0.848) between exercise (from 3.0 ± 0.34 to 14.60 ± 1.06 ml/100ml/min) and control sessions (from 2.38 ± 0.10 to 13.73 ± 1.05 ml/100ml/min) regarding the increase in forearm blood flow during reactive hyperemia. However, this response was higher postexercise (from 3.38 ± 0.31 to 16.58 ± 1.58 ml/100ml/min) than postcontrol intervention (from 2.04 ± 0.23 to 11.98 ± 1.16 ml/100ml/min, P interaction < 0.001). BEI increased at 30- and 60-min postexercise (from 32 ± 7 to 42 ± 7 and 46 ± 7%), but not after control intervention (from 33 ± 6 to 31 ± 5 and 33 ± 7%, P interaction = 0.014). In contrast, cBRS decreased at 30-min postexercise (from 10.3 ± 1.9 to 8.2 ± 1.4 and 10.3 ± 2.1 ms/mmHg) and increased postcontrol intervention (from 7.9 ± 0.9 to 10.5 ± 1.5 and 10.3 ± 1.3 ms/mmHg, P interaction = 0.012).
CONCLUSION
The results suggest that a single bout of aerobic exercise improved cardiac baroreflex function and increased vascular reactivity in patients with early-stage cirrhosis.",2020,"At baseline, there was no difference (P interaction = 0.848) between exercise (from 3.0 ± 0.34 to 14.60 ± 1.06 ml/100ml/min) and control sessions (from 2.38 ± 0.10 to 13.73 ± 1.05 ml/100ml/min) regarding the increase in forearm blood flow during reactive hyperemia.","['patients with cirrhosis', 'Thirteen patients with cirrhosis', 'patients with early-stage cirrhosis', 'patients with early cirrhosis']","['exercise and control intervention', 'aerobic exercise']","['BEI', 'cBRS', 'Vascular reactivity', 'Cardiac baroreflex function and vascular reactivity recovery', 'cardiac baroreflex function and vascular reactivity', 'cardiac baroreflex sensitivity (cBRS) and the baroreflex effectiveness index (BEI', 'postcontrol intervention', 'forearm blood flow', 'vascular reactivity', 'reactive hyperemia', 'cardiac baroreflex function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1299579', 'cui_str': 'Early cirrhosis'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}]",13.0,0.060632,"At baseline, there was no difference (P interaction = 0.848) between exercise (from 3.0 ± 0.34 to 14.60 ± 1.06 ml/100ml/min) and control sessions (from 2.38 ± 0.10 to 13.73 ± 1.05 ml/100ml/min) regarding the increase in forearm blood flow during reactive hyperemia.","[{'ForeName': 'Pedro Augusto de C', 'Initials': 'PAC', 'LastName': 'Mira', 'Affiliation': 'Cardiovascular Research Unit and Exercise Physiology, University Hospital and Faculty of Physical Education and Sports, Federal University of Juiz de Fora, Juiz de Fora, MG.'}, {'ForeName': 'Diane M N', 'Initials': 'DMN', 'LastName': 'Henrique', 'Affiliation': 'Faculty of Medicine.'}, {'ForeName': 'Renato Q', 'Initials': 'RQ', 'LastName': 'Loschi', 'Affiliation': 'Cardiovascular Research Unit and Exercise Physiology, University Hospital and Faculty of Physical Education and Sports, Federal University of Juiz de Fora, Juiz de Fora, MG.'}, {'ForeName': 'Maria F A', 'Initials': 'MFA', 'LastName': 'Falci', 'Affiliation': 'Cardiovascular Research Unit and Exercise Physiology, University Hospital and Faculty of Physical Education and Sports, Federal University of Juiz de Fora, Juiz de Fora, MG.'}, {'ForeName': 'Rosa V D', 'Initials': 'RVD', 'LastName': 'Guerrero', 'Affiliation': 'Cardiovascular Research Unit and Exercise Physiology, University Hospital and Faculty of Physical Education and Sports, Federal University of Juiz de Fora, Juiz de Fora, MG.'}, {'ForeName': 'Thompson B', 'Initials': 'TB', 'LastName': 'Machado Júnior', 'Affiliation': 'Hepatology Unit of Gastroenterology Department of University Hospital, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Kátia V B D', 'Initials': 'KVBD', 'LastName': 'Barbosa', 'Affiliation': 'Hepatology Unit of Gastroenterology Department of University Hospital, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Tarsila C da R', 'Initials': 'TCDR', 'LastName': 'Ribeiro', 'Affiliation': 'Hepatology Unit of Gastroenterology Department of University Hospital, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Fábio H de L', 'Initials': 'FHL', 'LastName': 'Pace', 'Affiliation': 'Hepatology Unit of Gastroenterology Department of University Hospital, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Martinez', 'Affiliation': 'Cardiovascular Research Unit and Exercise Physiology, University Hospital and Faculty of Physical Education and Sports, Federal University of Juiz de Fora, Juiz de Fora, MG.'}, {'ForeName': 'Mateus C', 'Initials': 'MC', 'LastName': 'Laterza', 'Affiliation': 'Cardiovascular Research Unit and Exercise Physiology, University Hospital and Faculty of Physical Education and Sports, Federal University of Juiz de Fora, Juiz de Fora, MG.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000474']
2413,32709779,Evaluation of skills transfer in short-term phacoemulsification surgery training program by International Council of Ophthalmology -Ophthalmology Surgical Competency Assessment Rubrics (ICO-OSCAR) and assessment of efficacy of ICO-OSCAR for objective evaluation of skills transfer.,"Purpose
To evaluate skills transfer in short-term phacoemulsification surgery training program by International Council of Ophthalmology -Ophthalmology Surgical Competency Assessment Rubrics (ICO-OSCAR) and assessment of efficacy of ICO-OSCAR for objective evaluation of skills transfer.
Methods
Prospective analysis of total 1300 phacoemulsification surgeries performed by 52 phacoemulsification trainees divided into three groups based on the previous cataract surgical experience. The pretraining and posttraining average mean scores, independent completion rates (ICR), and complication rates among the groups were calculated and statistically analyzed.
Results
Mean age of trainees (N = 52) was found to be 30.98 ± 2.44 years. Mean pretraining scores in the three groups were 42.8 ± 0.2, 46.6 ± 0.2, and 50.1 ± 0.1, respectively, and posttraining mean scores of the groups were 88.4 ± 0.2, 92.3 ± 0.2, and 94.3 ± 0.2, respectively, out of 100. Pretraining independent completion rates (%) were 22.1 ± 2.5, 52.1 ± 2.5, and 62 ± 3.7, respectively, and posttraining independent completion rates (%) were 74.8 ± 3, 79.7 ± 3, and 90.6 ± 3.5, respectively. Learning curves of all groups were noted to be steep. Rate of complications was within acceptable range, overall complication rate being 12.30% (160 out of 1300 cases). OSCAR scores correlate significantly (P = 0.0004) with ICR.
Conclusion
Steep learning curve for phacoemulsification can be made easy by the use of standardized rubrics, proper techniques, expert guidance, and adequate surgical volume. The previous SICS experience provides smoother learning curve. ICO-OSCAR is indicator of proficiency and provides constructive feedback and objective evaluation immediately after surgery as well as at the end of training. Short-term (1 Month) training program is an effective, efficient, and safe approach to progressively master phacoemulsification skills for trainees with SICS experience.",2020,"Rate of complications was within acceptable range, overall complication rate being 12.30% (160 out of 1300 cases).","['total 1300 phacoemulsification surgeries performed by 52 phacoemulsification trainees divided into three groups based on the previous cataract surgical experience', 'short-term phacoemulsification surgery training program by International Council of Ophthalmology', 'Mean age of trainees (N = 52) was found to be 30.98 ± 2.44 years', 'trainees with SICS experience']",['ICO-OSCAR'],"['completion rates (ICR), and complication rates', 'overall complication rate', 'OSCAR scores', 'Learning curves', 'Rate of complications', 'Mean pretraining scores', 'Ophthalmology Surgical Competency Assessment Rubrics (ICO-OSCAR']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0329207', 'cui_str': 'Astronotus ocellatus'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0329207', 'cui_str': 'Astronotus ocellatus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",1300.0,0.0188267,"Rate of complications was within acceptable range, overall complication rate being 12.30% (160 out of 1300 cases).","[{'ForeName': 'Khurshed M', 'Initials': 'KM', 'LastName': 'Bharucha', 'Affiliation': ""PBMA's H V Desai Eye Hospital, Hadapsar, Pune, Maharashtra, India.""}, {'ForeName': 'Vivek G', 'Initials': 'VG', 'LastName': 'Adwe', 'Affiliation': ""PBMA's H V Desai Eye Hospital, Hadapsar, Pune, Maharashtra, India.""}, {'ForeName': 'Atul M', 'Initials': 'AM', 'LastName': 'Hegade', 'Affiliation': ""PBMA's H V Desai Eye Hospital, Hadapsar, Pune, Maharashtra, India.""}, {'ForeName': 'Rahul D', 'Initials': 'RD', 'LastName': 'Deshpande', 'Affiliation': ""PBMA's H V Desai Eye Hospital, Hadapsar, Pune, Maharashtra, India.""}, {'ForeName': 'Madan D', 'Initials': 'MD', 'LastName': 'Deshpande', 'Affiliation': ""PBMA's H V Desai Eye Hospital, Hadapsar, Pune, Maharashtra, India.""}, {'ForeName': 'V K S', 'Initials': 'VKS', 'LastName': 'Kalyani', 'Affiliation': ""PBMA's H V Desai Eye Hospital, Hadapsar, Pune, Maharashtra, India.""}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_2058_19']
2414,32709786,Short-term outcome of botulinum neurotoxin A injection with or without sodium hyaluronate in the treatment of infantile esotropia-a prospective interventional study.,"Purpose
To compare the short-term outcome of botulinum neurotoxin A (BoNT-A) with or without sodium hyaluronate in the treatment of infantile esotropia (IE).
Methods
In this tertiary care hospital-based prospective, interventional, non-randomized study on infants with IE below one year of age, 25 cases were enrolled in the sodium hyaluronate (SH) group to receive 2.5 U BoNT-A injection combined with SH in each medial rectus muscle (MR). Thirty patients were enrolled in the control group to receive 2.5 U BoNT-A injection with normal saline in each MR. The change in mean primary ocular deviation (POD) and complications were assessed at 2 weeks, 1 month, 3 months, and 6 months post injection. Mann-Whitney U test was used for non-parametric unpaired data. Chi-square test and Fisher's exact test were used to test for the strength of the association between the two categorical variables.
Results
Satisfactory ocular alignment was achieved in 76% in SH group and 73% in the control group (P value = 0.80). While the change in mean POD was comparable (29.2 prism diopters [PD] vs 29.3 PD; P value = 0.65), the complication rates were significantly lesser in SH (16% vs 33.3%; P value = 0.14).
Conclusion
BoNT-A combined with SH is equally effective with lesser complications as compared to botulinum toxin alone in the treatment of IE.",2020,"Results
Satisfactory ocular alignment was achieved in 76% in SH group and 73% in the control group (P value = 0.80).","['Thirty patients were enrolled in the control group to', 'infants with IE below one year of age, 25 cases were enrolled in the', 'infantile esotropia (IE']","['botulinum neurotoxin', 'A injection with or without sodium hyaluronate', 'SH', 'botulinum toxin', 'sodium hyaluronate (SH) group to receive 2.5 U BoNT-A injection combined with SH', 'receive 2.5 U BoNT-A injection with normal saline', 'botulinum neurotoxin A (BoNT-A) with or without sodium hyaluronate']","['complication rates', 'mean primary ocular deviation (POD) and complications', 'Satisfactory ocular alignment', 'mean POD', 'SH']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0014877', 'cui_str': 'Esotropia'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C1295507', 'cui_str': 'Bontoxilysin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1112602', 'cui_str': 'Ocular deviation'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0729280', 'cui_str': 'Ocular muscle balance'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}]",30.0,0.0204661,"Results
Satisfactory ocular alignment was achieved in 76% in SH group and 73% in the control group (P value = 0.80).","[{'ForeName': 'Nitika', 'Initials': 'N', 'LastName': 'Pandey', 'Affiliation': ""Department of Ophthalmology, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': ""Department of Ophthalmology, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Rajat M', 'Initials': 'RM', 'LastName': 'Srivastava', 'Affiliation': ""Department of Ophthalmology, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Vinita', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': ""Department of Ophthalmology, King George's Medical University, Lucknow, Uttar Pradesh, India.""}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1552_19']
2415,32709851,"Blinatumomab in pediatric patients with relapsed/refractory acute lymphoblastic leukemia: results of the RIALTO trial, an expanded access study.",,2020,,['pediatric patients with relapsed/refractory acute lymphoblastic leukemia'],['Blinatumomab'],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}]","[{'cui': 'C3853839', 'cui_str': 'blinatumomab'}]",[],,0.0367656,,"[{'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': ""Department of Hematology and Oncology, IRCCS Bambino Gesù Children's Hospital, Rome, Sapienza, University of Rome, Rome, Italy.""}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Zugmaier', 'Affiliation': 'Amgen Research (Munich) GmbH, Munich, Germany. gerhardz@amgen.com.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Mergen', 'Affiliation': 'Amgen Research (Munich) GmbH, Munich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bader', 'Affiliation': 'Department for Children and Adolescents, University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Jeha', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Paul-Gerhardt', 'Initials': 'PG', 'LastName': 'Schlegel', 'Affiliation': ""University Children's Hospital Wuerzburg, Wuerzburg, Germany.""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Bourquin', 'Affiliation': ""Department of Pediatric Oncology, Children's Research Centre, University Children's Hospital Zurich, Zurich, Switzerland.""}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Handgretinger', 'Affiliation': ""Department of Hematology/Oncology, University Children's Hospital Tuebingen, Tuebingen, Germany.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Brethon', 'Affiliation': 'Pediatric Hematology and Immunology Department, Robert Debre Hospital, APHP, Paris, France.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Rossig', 'Affiliation': ""Department of Pediatric Hematology and Oncology, University Children's Hospital Muenster, Muenster, Germany.""}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Chen-Santel', 'Affiliation': 'Department of Pediatrics, Division of Oncology and Hematology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}]",Blood cancer journal,['10.1038/s41408-020-00342-x']
2416,32706698,A Dietary Mobile App for Patients Undergoing Hemodialysis: Prospective Pilot Study to Improve Dietary Intakes.,"BACKGROUND
Mobile technology has an impact on the health care sector, also within dietetics. Mobile health (mHealth) apps may be used for dietary assessment and self-monitoring, allowing for real-time reporting of food intakes. Changing eating behaviors is quite challenging, and patients undergoing hemodialysis, particularly, struggle to meet the target intakes set by dietary guidelines. Usage of mobile apps that are developed in a person-centered approach and in line with recommendations may support both patients and health care practitioners.
OBJECTIVE
This study is a pilot that aims at estimating the potential efficacy of a dietary intervention using a theory-based, person-centered smartphone app. Results will be used to improve both the app and a planned large-scale trial intended to assess app efficacy thoroughly.
METHODS
A prospective pilot study was performed at the hemodialysis unit of Al Qassimi Hospital (The Emirate of Sharjah). All patients that fulfilled the study inclusion criteria were considered eligible to be enrolled in the pilot study. Upon successful installation of the app, users met with a dietitian once a week. Outcomes were measured at baseline (T0) and 2 weeks post app usage (T1). This pilot is reported as per guidelines for nonrandomized pilot and feasibility studies and in line with the CONSORT 2010 checklist for reporting pilot or feasibility trials.
RESULTS
A total of 23 patients completed the pilot intervention. Mean energy intakes increased from 24.4 kcal/kg/day (SD 8.0) to 29.1 kcal/kg/day (SD 7.8) with a medium effect size (d=0.6, 95% CI 0.0-1.2). Mean protein intakes increased from 0.9 g/kg/day (SD 0.3) to 1.3 g/kg/day (SD 0.5) with a large effect size (d=1.0, 95% CI 0.4-1.6); mean intake of high biological value (%HBV) proteins also increased from 58.6% (SD 10.1) to 70.1% (SD 10.7) with a large effect size (d=1.1, 95% CI 0.5-1.7). Dietary intakes of minerals did not change, apart from sodium which decreased from a mean intake of 2218.8 mg/day (SD 631.6) to 1895.3 mg/day (SD 581.0) with a medium effect size (d=0.5, 95% CI 0.1-1.1). Mean serum phosphorus, potassium, and albumin levels did not change relevantly. Mean serum iron increased from 7.9 mg/dL (SD 2.8) to 11.5 mg/dL (SD 7.9) postintervention with a medium effect size (d=0.6, 95% CI 0.0-1.2).
CONCLUSIONS
This pilot study showed that the KELA.AE app has the potential to improve dietary intakes. Processes related to procedure, resources, tools, and app improvement for a future trial were assessed. A more extended intervention using a randomized controlled trial is required to estimate parameters concerning app efficacy accurately.",2020,"Mean protein intakes increased from 0.9 g/kg/day (SD 0.3) to 1.3 g/kg/day (SD 0.5) with a large effect size (d=1.0, 95% CI 0.4-1.6); mean intake of high biological value (%HBV) proteins also increased from 58.6% (SD 10.1) to 70.1% (SD 10.7) with a large effect size (d=1.1, 95% CI 0.5-1.7).","['All patients that fulfilled the study inclusion criteria were considered eligible to be enrolled in the pilot study', 'Patients Undergoing Hemodialysis', 'hemodialysis unit of Al Qassimi Hospital', '23 patients completed the pilot intervention']","['KELA.AE', 'dietary intervention']","['Mean protein intakes', 'Mean serum iron', 'mean intake of high biological value', 'Mean serum phosphorus, potassium, and albumin levels', 'Mean energy intakes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0019005', 'cui_str': 'Hemodialysis machine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",23.0,0.105351,"Mean protein intakes increased from 0.9 g/kg/day (SD 0.3) to 1.3 g/kg/day (SD 0.5) with a large effect size (d=1.0, 95% CI 0.4-1.6); mean intake of high biological value (%HBV) proteins also increased from 58.6% (SD 10.1) to 70.1% (SD 10.7) with a large effect size (d=1.1, 95% CI 0.5-1.7).","[{'ForeName': 'Cosette', 'Initials': 'C', 'LastName': 'Fakih El Khoury', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Crutzen', 'Affiliation': 'Department of Health Promotion, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Jos M G A', 'Initials': 'JMGA', 'LastName': 'Schols', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Ruud J G', 'Initials': 'RJG', 'LastName': 'Halfens', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Mirey', 'Initials': 'M', 'LastName': 'Karavetian', 'Affiliation': 'Department of Health Sciences, Zayed University, Dubai, United Arab Emirates.'}]",Journal of medical Internet research,['10.2196/17817']
2417,32706704,Features of a Patient Portal for Blood Test Results and Patient Health Engagement: Web-Based Pre-Post Experiment.,"BACKGROUND
The use of patient portals for presenting health-related patient data, such as blood test results, is becoming increasingly important in health practices. Patient portals have the potential to enhance patient health engagement, but content might be misinterpreted.
OBJECTIVE
This study aimed to discover whether the way of presenting blood test outcomes in an electronic patient portal is associated with patient health engagement and whether this varies across different blood test outcomes.
METHODS
A 2x3 between-subjects experiment was conducted among members of the Nivel Dutch Health Care Consumer Panel. All participants read a scenario in which they were asked to imagine themselves receiving blood test results. These results differed in terms of the presented blood values (ie, normal vs partially abnormal vs all abnormal) as well as in terms of whether the results were accompanied with explanatory text and visualization. Patient health engagement was measured both before (T0) and after (T1) participants were exposed to their fictive blood test results.
RESULTS
A total 487 of 900 invited members responded (response rate 54%), of whom 50.3% (245/487) were female. The average age of the participants was 52.82 years (SD 15.41 years). Patient health engagement saw either a significant decrease or a nonsignificant difference in the experimental groups after viewing the blood test results. The mean difference was smaller in the groups that received blood test results with additional text and visualization (mean T0 5.33, SE 0.08; mean T1 5.14, SE 0.09; mean difference 0.19, SE 0.08, P=.02) compared with groups that received blood test results without explanatory text and visualization (mean T0 5.19, SE 0.08; mean T1 4.55, SE 0.09; mean difference 0.64, SE 0.08, P<.001). Adding text and visualization, in particular, reduced the decline in patient health engagement in participants who received normal results or mixed results (ie, combination of normal and abnormal results).
CONCLUSIONS
Adding text and visualization features can attenuate the decrease in patient health engagement in participants who receive outcomes of a blood test via a patient portal, particularly when blood test results are (partly) normal. This suggests that explanatory text and visualization can be reassuring. Future research is warranted to determine whether these results can be generalized to a patient population who receive their actual blood test results.",2020,"Adding text and visualization, in particular, reduced the decline in patient health engagement in participants who received normal results or mixed results (ie, combination of normal and abnormal results).
","['participants who received normal results or mixed results (ie, combination of normal and abnormal results', 'The average age of the participants was 52.82 years (SD 15.41 years', 'A total 487 of 900 invited members responded (response rate 54%), of whom 50.3% (245/487) were female', 'A 2x3 between-subjects experiment was conducted among members of the Nivel Dutch Health Care Consumer Panel']",[],"['blood values', 'Patient health engagement', 'patient health engagement']","[{'cui': 'C0459422', 'cui_str': 'Normal result'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0459424', 'cui_str': 'Abnormal result'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0665509', 'cui_str': 'OF 900'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]",[],"[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",900.0,0.0704985,"Adding text and visualization, in particular, reduced the decline in patient health engagement in participants who received normal results or mixed results (ie, combination of normal and abnormal results).
","[{'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Struikman', 'Affiliation': 'Nivel (Netherlands Institute for Health Services Research), Utrecht, Netherlands.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Bol', 'Affiliation': 'Department of Communication and Cognition, Tilburg School of Humanities and Digital Sciences, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Annelijn', 'Initials': 'A', 'LastName': 'Goedhart', 'Affiliation': 'Saltro, Diagnostics Center for Health Care, Utrecht, Netherlands.'}, {'ForeName': 'Julia C M', 'Initials': 'JCM', 'LastName': 'van Weert', 'Affiliation': 'Department of Communication Science, Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Talboom-Kamp', 'Affiliation': 'Saltro, Diagnostics Center for Health Care, Utrecht, Netherlands.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'van Delft', 'Affiliation': 'Saltro, Diagnostics Center for Health Care, Utrecht, Netherlands.'}, {'ForeName': 'Anne E M', 'Initials': 'AEM', 'LastName': 'Brabers', 'Affiliation': 'Nivel (Netherlands Institute for Health Services Research), Utrecht, Netherlands.'}, {'ForeName': 'Liset', 'Initials': 'L', 'LastName': 'van Dijk', 'Affiliation': 'Nivel (Netherlands Institute for Health Services Research), Utrecht, Netherlands.'}]",Journal of medical Internet research,['10.2196/15798']
2418,32706658,Scheduled Telephone Support for Internet Cognitive Behavioral Therapy for Depression in Patients at Risk for Dropout: Pragmatic Randomized Controlled Trial.,"BACKGROUND
Therapist-supported, internet-delivered cognitive behavioral therapy (iCBT) is efficient in the treatment of depression. However, the optimal mode and intensity of therapist support remain to be identified. Scheduled telephone support (STS) may improve adherence and outcomes but, as it is time- and resource-consuming, should be reserved for patients for whom the usual support may be insufficient.
OBJECTIVE
This paper aims to reveal whether add-on STS for patients at risk of dropping out improves treatment adherence and symptoms in iCBT for depression.
METHODS
Among patients participating in an ongoing large observational routine clinical practice study of iCBT for depression delivered nationwide by Helsinki University Hospital (HUS-iCBT), those demonstrating a ≥14-day delay in initiation of treatment received invitations to this subsidiary STS study. A total of 100 consenting patients were randomly allocated to either HUS-iCBT as usual (control group, n=50) or HUS-iCBT plus add-on STS (intervention group, n=50). Proportions of those reaching midtreatment and treatment end point served as the primary outcome; secondary outcomes were change in Beck Depression Inventory (BDI)-measured depressive symptoms and time spent in treatment.
RESULTS
Add-on STS raised the proportion of patients reaching midtreatment compared with HUS-iCBT as usual (29/50, 58% vs 18/50, 36%; P=.045) and treatment end point (12/50, 24% vs 3/50, 6%; P=.02). Change in BDI score also favored add-on STS (3.63 points vs 1.1 points; P=.049), whereas duration of treatment did not differ.
CONCLUSIONS
Add-on STS enhances adherence and symptom improvement of patients at risk of dropping out of iCBT for depression in routine clinical practice.
TRIAL REGISTRATION
International Standard Randomised Controlled Trial Number (ISRCTN) 55123131; http://www.isrctn.com/ISRCTN55123131.",2020,"Change in BDI score also favored add-on STS (3.63 points vs 1.1 points; P=.049), whereas duration of treatment did not differ.
","['patients participating in an ongoing large observational routine clinical practice study of iCBT for depression delivered nationwide by Helsinki University Hospital (HUS-iCBT', '100 consenting patients']","['Scheduled Telephone Support for Internet Cognitive Behavioral Therapy', 'HUS-iCBT as usual (control group, n=50) or HUS-iCBT plus add-on STS (intervention', 'Scheduled telephone support (STS', 'Therapist-supported, internet-delivered cognitive behavioral therapy (iCBT']","['Change in BDI score', 'change in Beck Depression Inventory (BDI)-measured depressive symptoms and time spent in treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0019061', 'cui_str': 'Hemolytic uremic syndrome'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0019061', 'cui_str': 'Hemolytic uremic syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",100.0,0.220979,"Change in BDI score also favored add-on STS (3.63 points vs 1.1 points; P=.049), whereas duration of treatment did not differ.
","[{'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Pihlaja', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Hospital District of Helsinki and Uusimaa, Helsinki, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Lahti', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jari Olavi', 'Initials': 'JO', 'LastName': 'Lipsanen', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Ritola', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Hospital District of Helsinki and Uusimaa, Helsinki, Finland.'}, {'ForeName': 'Eero-Matti', 'Initials': 'EM', 'LastName': 'Gummerus', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Hospital District of Helsinki and Uusimaa, Helsinki, Finland.'}, {'ForeName': 'Jan-Henry', 'Initials': 'JH', 'LastName': 'Stenberg', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Hospital District of Helsinki and Uusimaa, Helsinki, Finland.'}, {'ForeName': 'Grigori', 'Initials': 'G', 'LastName': 'Joffe', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Hospital District of Helsinki and Uusimaa, Helsinki, Finland.'}]",Journal of medical Internet research,['10.2196/15732']
2419,32706659,Predictors of Self-Determined Module Choice in a Web-Based Computer-Tailored Diet and Physical Activity Intervention: Secondary Analysis of Data From a Randomized Controlled Trial.,"BACKGROUND
Tailoring an online intervention to participant preferences (eg, by giving participants a choice which modules to follow) may increase engagement in the intervention, motivation for behavioral change, and possibly intervention effects. So far, little is known about what characteristics predict these module choices. Filling this knowledge gap is useful for optimizing program engagement.
OBJECTIVE
We investigated participant choice for a dietary and/or physical activity (PA) promotion module in our web-based computer-tailored intervention based on self-determination theory (SDT) and motivational interviewing (MI). Furthermore, we investigated which demographic characteristics, current behavior, psychosocial constructs and constructs from SDT and MI, and program-related variables such as advice on which module to follow were associated with these choices.
METHODS
Observational data were used from the randomized controlled trial MyLifestyleCoach of participants who were randomized into the intervention condition, completed the baseline questionnaire, and made a module choice in the opening session of the intervention. Here, they received advice on their own dietary and PA behavior. At the session's end, they chose which lifestyle modules they would like to follow (both, diet, PA, or no module). Measurements included demographic information; self-reported diet and PA; and several psychosocial, SDT, and MI constructs. In total, data from 619 Dutch adults (59.6% women; mean age was 51.9 [SD 13.5] years) were analyzed. A stepwise multinomial logistic regression analysis was conducted to investigate which characteristics are related to module choice; the diet module served as reference category as almost everyone was advised to follow this module.
RESULTS
Of this sample, 54.8% (339/619) chose to do both the diet and PA module, 25.4% (157/619) chose to follow the diet module, 17.8% (110/619) preferred to follow no module, and 2.1% (13/619) chose to do the PA module only. Furthermore, it was found that older people, those who consumed more fruit, and those who scored lower on importance to change their current diet were more likely to choose no module compared to the diet module. People who had more motivation to change their current PA and those who received strong advice compared with slight advice to follow the diet module were more likely to choose both modules compared with the diet module only.
CONCLUSIONS
The results show that more than half of the sample was interested in following both the diet and PA module in this online lifestyle intervention. Several characteristics were found to be related to module choice. A future challenge is to examine how this knowledge can be used to improve future interventions, such as tailoring (messages or content) on specific groups or examining where and how MI could be used to motivate people to make a certain module choice.
TRIAL REGISTRATION
Netherlands Trial Register NL7333; https://www.trialregister.nl/trial/7333.",2020,"Furthermore, it was found that older people, those who consumed more fruit, and those who scored lower on importance to change their current diet were more likely to choose no module compared to the diet module.","['619 Dutch adults (59.6% women; mean age was 51.9 [SD 13.5] years) were analyzed', 'People who had more motivation to change their current PA and those who received']","['Self-Determined Module Choice in a Web-Based Computer-Tailored Diet and Physical Activity Intervention', 'dietary and/or physical activity (PA) promotion module', 'strong advice', 'self-determination theory (SDT) and motivational interviewing (MI']","['demographic information; self-reported diet and PA; and several psychosocial, SDT, and MI constructs']","[{'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517559', 'cui_str': '13.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}]",619.0,0.0446689,"Furthermore, it was found that older people, those who consumed more fruit, and those who scored lower on importance to change their current diet were more likely to choose no module compared to the diet module.","[{'ForeName': 'Juul M J', 'Initials': 'JMJ', 'LastName': 'Coumans', 'Affiliation': 'Department of Health Psychology, Faculty of Psychology, Open University of the Netherlands, Heerlen, Netherlands.'}, {'ForeName': 'Catherine A W', 'Initials': 'CAW', 'LastName': 'Bolman', 'Affiliation': 'Department of Health Psychology, Faculty of Psychology, Open University of the Netherlands, Heerlen, Netherlands.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Oenema', 'Affiliation': 'Department of Health Promotion, Caphri, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Lechner', 'Affiliation': 'Department of Health Psychology, Faculty of Psychology, Open University of the Netherlands, Heerlen, Netherlands.'}]",Journal of medical Internet research,['10.2196/15024']
2420,32709516,Efficacy of Kinesio Taping and Postural Correction Exercises on Levator Scapula Electromyographic Activities in Mechanical Cervical Dysfunction: A Randomized Blinded Clinical Trial.,"OBJECTIVE
Mechanical neck dysfunction (MND) is a major health burden. Although postural correction exercises (PCEs) are commonly used for its treatment, efficacy of Kinesio Taping (KT) has received considerable attention. This study was conducted to determine the effect of KT and PCEs on levator scapula (LS) electromyography.
METHODS
Ninety-one patients with MND were randomly assigned into 1 of 3 groups that received 4 weeks' treatment: group A, KT; group B, PCE; and group C, both interventions. Neck pain, LS root mean square (RMS), and median frequency (MDF) were measured pretreatment and post-treatment with the Numerical Pain Rating Scale and surface electromyography, respectively, by an assessor blinded to the patients' allocation.
RESULTS
Multivariate analysis of variance indicates a statistically significant group-by-time interaction (P = .000). Pain intensity was significantly reduced in group C more than in group B (P = .001). Mean values of RMS were significantly reduced in group C compared to both group A (P = .001) and group B (P = .022), whereas MDF was significantly increased in group C compared to either group A (P = .00) or group B (P = .026), and in group B compared to group A (P = 0.26). A paired t test revealed that there was a significant decrease in pain and RMS, and a significant increase in MDF in all groups (P < .01).
CONCLUSION
Application of both KT and PCE combined can significantly reduce neck pain and normalize LS activities in patients with MND more than the application of either intervention.",2020,"Mean values of RMS were significantly reduced in group C compared to both group A (P = .001) and group B (P = .022), whereas MDF was significantly increased in group C compared to either group A (P = .00) or group B (P = .026), and in group B compared to group A (P = 0.26).","['patients with MND', 'Mechanical Cervical Dysfunction', 'Ninety-one patients with MND']","['KT and PCEs', 'KT and PCE', 'Kinesio Taping and Postural Correction Exercises', 'Kinesio Taping (KT', 'postural correction exercises (PCEs', 'PCE']","['levator scapula (LS) electromyography', 'Pain intensity', 'Mean values of RMS', 'Neck pain, LS root mean square (RMS), and median frequency (MDF', 'MDF', 'Numerical Pain Rating Scale and surface electromyography', 'Levator Scapula Electromyographic Activities', 'neck pain and normalize LS activities', 'pain and RMS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0246101', 'cui_str': 'PCV regimen'}]","[{'cui': 'C0036277', 'cui_str': 'Bone structure of scapula'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",91.0,0.0936901,"Mean values of RMS were significantly reduced in group C compared to both group A (P = .001) and group B (P = .022), whereas MDF was significantly increased in group C compared to either group A (P = .00) or group B (P = .026), and in group B compared to group A (P = 0.26).","[{'ForeName': 'Aliaa M', 'Initials': 'AM', 'LastName': 'Elabd', 'Affiliation': 'Basic Sciences Department, Faculty of Physical Therapy, Pharos University in Alexandria, Egypt. Electronic address: Aliaelabd88@gmail.com.'}, {'ForeName': 'Abeer R', 'Initials': 'AR', 'LastName': 'Ibrahim', 'Affiliation': 'Basic Sciences Department, Faculty of Physical Therapy, Cairo University, Egypt; Physiotherapy Department, College of Applied Medical Sciences, Umm Al-Qura University, Saudi Arabia.'}, {'ForeName': 'Haytham M', 'Initials': 'HM', 'LastName': 'Elhafez', 'Affiliation': 'Basic Sciences Department, Faculty of Physical Therapy, Cairo University, Egypt; Dean, Faculty of physical therapy, Suez University, Egypt.'}, {'ForeName': 'Hussien A', 'Initials': 'HA', 'LastName': 'Hussien', 'Affiliation': 'Department of Orthopedics, Ahmed Maher Teaching Hospital, Egypt.'}, {'ForeName': 'Omar M', 'Initials': 'OM', 'LastName': 'Elabd', 'Affiliation': 'Department of Musculoskeletal Disorders and Their Surgery, Faculty of Physical Therapy, Delta University for Science and Technology, Egypt.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.05.010']
2421,32706708,Evaluation of a Web-Based Self-Management Program for Patients With Cardiovascular Disease: Explorative Randomized Controlled Trial.,"BACKGROUND
Web-based self-management programs have the potential to support patients with cardiovascular disease (CVD) in their self-management (eg, by focusing on behavior change and improving physical activity). The intervention mapping framework was used to develop a web-based program called Vascular View. The Vascular View program contained 6 modules (coping with CVD, setting boundaries, lifestyle, healthy nutrition, being physically active, interaction with health professionals) aiming to increase self-management behavior by tailoring to the perceived problems and (support) needs of patients after CVD.
OBJECTIVE
The aim was to test the effectiveness of Vascular View before embarking on a full-scale randomized clinical trial (RCT) by evaluating the potential effectiveness and effect sizes of the Vascular View program and identifying outcome measures most likely to capture the potential benefits.
METHODS
An explorative RCT was performed. Both control and intervention groups received care as usual and, in addition, the intervention group received 12 months of access to a web-based self-management program. Assessment occurred at baseline, 6 months, and 12 months. Outcome measures included general patient-reported outcome measurements: Illness Perception Questionnaire (IPQ), Rand-36, Patient Activation Measure, and patient self-efficacy. Module-specific patient-reported outcome measurements were Beliefs about Medicines Questionnaire, International Physical Activity Questionnaire, Dutch Healthy Diet Index, Fagerström Test for Nicotine Dependence (FTND), Alcohol Use Disorders Identification Test, and Perceived Efficacy in Patient-Physician Interaction. Linear mixed models for repeated measures using intention-to-treat and per-protocol analysis were applied to study differences between the patients in the intervention and control groups. Floor and ceiling effects were explored to give insight into the outcome measures most likely to capture the potential benefits.
RESULTS
A total of 105 patients in the control group and 103 patients in the intervention group participated in the study. A positive direction of change between baseline and 12 months was shown for most outcome measurements in favor of the intervention group, of which 2 out of 10 outcomes showed a significant effect: attribution of cause of the disease to risk factors and immunity factors (IPQ) and dependency of nicotine (FTND). Floor and ceiling effects were seen in the IPQ, Rand-36, and the self-efficacy questionnaire.
CONCLUSIONS
No conclusion for the efficacy of the Vascular View program or selection of outcome measurements can be taken yet. A process evaluation will be conducted to gain thorough insight into the working elements of the program, patient needs in eHealth, and the use of the program by patients. This can determine for whom web-based self-management programs will work and help to adapt the program.
TRIAL REGISTRATION
Dutch Trial Register NTR5412; https://www.trialregister.nl/trial/5303.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.2196/resprot.6352.",2020,"A positive direction of change between baseline and 12 months was shown for most outcome measurements in favor of the intervention group, of which 2 out of 10 outcomes showed a significant effect: attribution of cause of the disease to risk factors and immunity factors (IPQ) and dependency of nicotine (FTND).","['Patients With Cardiovascular Disease', '105 patients in the control group and 103 patients in the intervention group participated in the study', 'patients with cardiovascular disease (CVD']","['Web-Based Self-Management Program', 'care as usual and, in addition, the intervention group received 12 months of access to a web-based self-management program', 'NTR5412']","['self-efficacy questionnaire', 'Beliefs about Medicines Questionnaire, International Physical Activity Questionnaire, Dutch Healthy Diet Index, Fagerström Test for Nicotine Dependence (FTND), Alcohol Use Disorders Identification Test, and Perceived Efficacy in Patient-Physician Interaction', 'significant effect: attribution of cause of the disease to risk factors and immunity factors (IPQ) and dependency of nicotine (FTND', 'general patient-reported outcome measurements: Illness Perception Questionnaire (IPQ), Rand-36, Patient Activation Measure, and patient self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031830', 'cui_str': 'Physician Patient Relations'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",105.0,0.0846981,"A positive direction of change between baseline and 12 months was shown for most outcome measurements in favor of the intervention group, of which 2 out of 10 outcomes showed a significant effect: attribution of cause of the disease to risk factors and immunity factors (IPQ) and dependency of nicotine (FTND).","[{'ForeName': 'Marscha M', 'Initials': 'MM', 'LastName': 'Engelen', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'van Dulmen', 'Affiliation': 'Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Puijk-Hekman', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Hester', 'Initials': 'H', 'LastName': 'Vermeulen', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Maria Wg', 'Initials': 'MW', 'LastName': 'Nijhuis-van der Sanden', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Sebastian Jh', 'Initials': 'SJ', 'LastName': 'Bredie', 'Affiliation': 'Department of Internal Medicine, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Betsie Gi', 'Initials': 'BG', 'LastName': 'van Gaal', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}]",Journal of medical Internet research,['10.2196/17422']
2422,32715455,Minimally Invasive Percutaneous Nephrolithotomy with a Novel Vacuum-assisted Access Sheath for obstructive calculous pyonephrosis ：A Randomized Study.,"PURPOSE
To investigate the safety and efficacy of Minimally Invasive Percutaneous Nephrolithotomy (MPCNL) combined with Vacuum-assisted Access Sheath in the treatment of obstructive calculous pyonephrosis.
MATERIALS AND METHODS
Seventy-six patients with obstructive calculous pyonephrosis, who were planned to receive MPCNL, were randomly divided into two groups. Group A was treated with Amplatz sheath combined with Cyberwand double probe ultrasound lithotripsy, and group B was treated with Vacuum-assisted Access Sheath (VAAS, ClearPetra, Well lead Medical) combined with holmium laser lithotripsy. The primary outcome was the operation successful rate. Other perioperative, and postoperative data such as operation time, stone free rate and complications were compared between groups.
RESULTS
Single 20F access sheath was established in all cases. All patients underwent one-stage procedure. Compared with group A, group B had a higher initial stone-free rate (84.2% vs 63.1%, P= .037). The operation time of group B was 56.3 ± 19.83 min, significantly shorter than that of group A at 70.4 ± 14.83 min. The complication rate of B group was 15.8%, which was lower than that of group A (P= .035 ). Five patients (15.8 %) of group B had a postoperative fever (>38.5 ºC) (Clavien grade 2) that required additional antibiotics; whereas 8 patients (21.1 %) of group A (P= .361). There was no blood transfusion in group A, and one case in group B required transfusion.
CONCLUSION
One-stage MPCNL combined with Vacuum-assisted Access Sheath and holmium laser lithotripsy is a simple, safe, effective, and ergonomically practical method for selected patients with obstructive calculous pyonephrosis.",2020,"The operation time of group B was 56.3 ± 19.83 min, significantly shorter than that of group A at 70.4 ± 14.83 min.","['Seventy-six patients with obstructive calculous pyonephrosis, who were planned to receive', 'obstructive calculous pyonephrosis', 'selected patients with obstructive calculous pyonephrosis']","['MPCNL', 'Minimally Invasive Percutaneous Nephrolithotomy with a Novel Vacuum-assisted Access Sheath', 'Minimally Invasive Percutaneous Nephrolithotomy (MPCNL)\xa0combined with Vacuum-assisted Access Sheath', 'Vacuum-assisted Access Sheath and holmium laser lithotripsy', 'Amplatz sheath combined with Cyberwand double probe ultrasound lithotripsy, and group B was treated with Vacuum-assisted Access Sheath (VAAS, ClearPetra, Well lead Medical) combined with holmium laser lithotripsy']","['postoperative fever', 'initial stone-free rate', 'operation successful rate', 'complication rate', 'operation time, stone free rate and complications', 'blood transfusion']","[{'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034216', 'cui_str': 'Pyonephrosis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0441087', 'cui_str': 'Double probe'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0424786', 'cui_str': 'Postoperative fever'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",76.0,0.0757774,"The operation time of group B was 56.3 ± 19.83 min, significantly shorter than that of group A at 70.4 ± 14.83 min.","[{'ForeName': 'Dehui', 'Initials': 'D', 'LastName': 'Lai', 'Affiliation': 'Urology, Fifth Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China. dehuilai@hotmail.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Urology, Jinshazhou Hospital of Guangzhou Chinese Medicine University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Meiling', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Urology, Fifth Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yongzhong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Urology, Fifth Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Urology, Fifth Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Sheng', 'Affiliation': 'Urology, Fifth Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xingrong', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'College of Materials Science and Engineering, Key Lab of Guangdong Province for High Property and Functional Polymer Materials, South China University of Technology, Guangzhou, China.'}]",Urology journal,['10.22037/uj.v16i7.5577']
2423,32706667,"An Internet-Based Psychological Intervention With a Serious Game to Improve Vitality, Psychological and Physical Condition, and Immune Function in Healthy Male Adults: Randomized Controlled Trial.","BACKGROUND
Recently, internet-based cognitive behavioral therapy (ICBT) and serious gaming interventions have been suggested to enhance accessibility to interventions and engagement in psychological interventions that aim to promote health outcomes. Few studies, however, have investigated their effectiveness in the context of simulated real-life challenges.
OBJECTIVE
We aimed to examine the effectivity of a guided ICBT combined with a serious gaming intervention in improving self-reported psychophysiological and immunological health endpoints in response to psychophysiological and immune-related challenges.
METHODS
Sixty-nine healthy men were randomly assigned to the intervention condition, receiving ICBT combined with serious gaming for 6 weeks, or the control condition, receiving no intervention. Self-reported vitality was the primary endpoint. Other self-reported psychophysiological and immunological endpoints were assessed following various challenges, including a bacillus Calmette-Guérin vaccination evoking pro-inflammatory responses, 1 and 4 weeks after the intervention period.
RESULTS
Although the intervention did not affect vitality-associated parameters, self-reported sleep problems (P=.027) and bodily sensations (P=.042) were lower directly after the intervention compared with controls. Furthermore, wellbeing (P=.024) was higher in the intervention group after the psychophysiological challenges. Although no significant group differences were found for the psychophysiological and immunological endpoints, the data provided preliminary support for increased immunoglobulin antibody responses at the follow-up time points (P<.05). Differential chemokine endpoints between conditions were observed at the end of the test day.
CONCLUSIONS
The present study provides some support for improving health endpoints with an innovative ICBT intervention. Future research should replicate and further extend the present findings by consistently including challenges and a wide range of immune parameters into the study design.
TRIAL REGISTRATION
Nederlands Trial Register NTR5610; https://www.trialregister.nl/trial/5466.",2020,"Although the intervention did not affect vitality-associated parameters, self-reported sleep problems (P=.027) and bodily sensations (P=.042) were lower directly after the intervention compared with controls.","['Sixty-nine healthy men', 'Healthy Male Adults']","['ICBT combined with serious gaming for 6 weeks, or the control condition, receiving no intervention', 'guided ICBT combined with a serious gaming intervention', 'internet-based cognitive behavioral therapy (ICBT', 'Internet-Based Psychological Intervention With a Serious Game']","['vitality-associated parameters, self-reported sleep problems', 'immunoglobulin antibody responses', 'bodily sensations']","[{'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0686751', 'cui_str': 'Well male adult'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",69.0,0.0729687,"Although the intervention did not affect vitality-associated parameters, self-reported sleep problems (P=.027) and bodily sensations (P=.042) were lower directly after the intervention compared with controls.","[{'ForeName': 'Lemmy', 'Initials': 'L', 'LastName': 'Schakel', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Dieuwke S', 'Initials': 'DS', 'LastName': 'Veldhuijzen', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Henriët', 'Initials': 'H', 'LastName': 'van Middendorp', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Prins', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Anne M H F', 'Initials': 'AMHF', 'LastName': 'Drittij', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Vrieling', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Leo G', 'Initials': 'LG', 'LastName': 'Visser', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Tom H M', 'Initials': 'THM', 'LastName': 'Ottenhoff', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Simone A', 'Initials': 'SA', 'LastName': 'Joosten', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Andrea W M', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, Netherlands.'}]",Journal of medical Internet research,['10.2196/14861']
2424,32706674,Novel Stepped Care Approach to Provide Education and Exercise Therapy for Patellofemoral Pain: Feasibility Study.,"BACKGROUND
Patellofemoral pain (PFP) impairs joint- and health-related quality of life and may be associated with knee osteoarthritis. We developed a novel, 2-phase, stepped-care approach for PFP, combining (1) self-directed web-based education and exercise therapy with (2) physiotherapist-supported education and exercise therapy. Physiotherapy sessions can be provided using 2 different modalities: face-to-face and telerehabilitation.
OBJECTIVE
This study aims to (1) determine the feasibility of our stepped-care approach, (2) explore patient-reported outcomes following self-directed web-based education and exercise therapy in people with PFP (phase 1), and (3) estimate the differences in treatment effects between face-to-face and telerehabilitation to support further education and exercise therapy (phase 2) in those who had not completely recovered following self-directed care.
METHODS
Phase 1 involved 6 weeks of self-directed web-based education and exercise therapy. Phase 2 involved random allocation to a further 12 weeks of physiotherapist-led (up to 8 sessions) education and exercise therapy delivered face-to-face or via telerehabilitation to participants who did not rate themselves as completely recovered following phase 1. Feasibility indicators of process, adherence, and participant retention were collected as primary outcomes alongside patient-reported outcomes on Global Rating of Change and knee pain, disability, knee-related quality of life, pain catastrophism, kinesiophobia, and knee self-efficacy. All participants were assessed at baseline, 6 weeks, and 18 weeks.
RESULTS
A total of 71 participants were screened to identify 35 participants with PFP to enter the study. Overall, 100% (35/35) and 88% (31/35) of the participants were followed up with at 6 and 18 weeks, respectively. In phase 1 of the study, participants accessed the My Knee Cap website for an average of 6 (7.5) days and performed the exercises for an average of 2.5 (3.6) times per week. A total of 20% (7/35) of the participants reported that they had completely recovered at 6 weeks. Furthermore, 93% (26/28) of the participants who were followed up and had not completely recovered at 6 weeks agreed to be enrolled in phase 2. No statistically significant differences were found between the face-to-face and telerehabilitation groups for any outcome. The novel stepped-care approach was associated with marked improvement or complete recovery in 40% (14/35) of the participants following phase 1 and 71% (25/35) of the participants following phase 2.
CONCLUSIONS
Self-directed web-based education and exercise therapy for people with PFP is feasible, as noted by the high rate of participant retention and home exercise adherence achieved in this study. Furthermore, 20% (7/35) of people reported complete recovery at 6 weeks. Both face-to-face and telerehabilitation physiotherapy should be considered for those continuing to seek care, as there is no difference in outcomes between these delivery modes. Determining the efficacy of the stepped-care model may help guide more efficient health care for PFP.",2020,No statistically significant differences were found between the face-to-face and telerehabilitation groups for any outcome.,"['people with PFP (phase 1', '71 participants were screened to identify 35 participants with PFP to enter the study']","['Physiotherapy sessions', 'physiotherapist-led (up to 8 sessions) education and exercise therapy delivered face-to-face or via telerehabilitation', 'Novel Stepped Care Approach to Provide Education and Exercise Therapy', 'self-directed web-based education and exercise therapy', 'Self-directed web-based education and exercise therapy', 'PFP, combining (1) self-directed web-based education and exercise therapy with (2) physiotherapist-supported education and exercise therapy']","['Global Rating of Change and knee pain, disability, knee-related quality of life, pain catastrophism, kinesiophobia, and knee self-efficacy', 'Feasibility indicators of process, adherence, and participant retention', 'My Knee Cap website']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}]",71.0,0.133706,No statistically significant differences were found between the face-to-face and telerehabilitation groups for any outcome.,"[{'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'De Oliveira Silva', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Marcella F', 'Initials': 'MF', 'LastName': 'Pazzinatto', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Crossley', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Fabio M', 'Initials': 'FM', 'LastName': 'Azevedo', 'Affiliation': 'Laboratory of Biomechanics and Motor Control, Sao Paulo State University, Presidente Prudente, Brazil.'}, {'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Barton', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}]",Journal of medical Internet research,['10.2196/18584']
2425,32706681,Recruiting and Retaining Youth and Young Adults in the Policy and Communication Evaluation (PACE) Vermont Study: Randomized Controlled Trial of Participant Compensation.,"BACKGROUND
The standard approach for evaluating the effects of population-level substance use prevention efforts on youth and young adult perceptions and behaviors has been to compare outcomes across states using national surveillance data. Novel surveillance methods that follow individuals over shorter time intervals and capture awareness of substance use prevention policy and communication efforts may provide a stronger basis for their evaluation than annual cross-sectional studies.
OBJECTIVE
This study aimed to identify a combination of strategies to recruit a sample of youth and young adults sufficiently representative of the Vermont population and determine how best to retain a web-based panel of youth and young adults over a 6-month period.
METHODS
Eligible participants were Vermont residents aged 12 to 25 years who were willing to complete three 10 to 15-minute web-based surveys over a 6-month period. Recruitment was conducted via the following three main mechanisms: (1) web-based recruitment (paid and unpaid), (2) community-based recruitment through partners, and (3) participant referrals via a personalized link. Upon completion of the baseline survey, participants were randomly assigned to one of the following three retention incentive conditions: (1) guaranteed incentive (US $10), (2) lottery incentive (US $50 weekly lottery drawing), and (3) preferred method (guaranteed or lottery). Analyses examined cost per survey start by recruitment source, distribution of demographic characteristics across incentive conditions, and retention by study condition at 3-month and 6-month follow-ups.
RESULTS
Over a 10-week period in 2019, we recruited 480 eligible youth (aged 12-17 years) and 1037 eligible young adults (aged 18-25 years) to the Policy and Communication Evaluation (PACE) Vermont Study. Facebook and Instagram advertising produced the greatest number of survey starts (n=2013), followed by posts to a state-wide web-based neighborhood forum (n=822) and Google advertisements (n=749). Retention was 78.11% (1185/1517) at 3 months and 72.18% (1095/1517) at 6 months. Retention was equivalent across all incentive study conditions at both waves, despite a strong stated preference among study participants for the guaranteed payment at baseline. Youth had greater retention than young adults at both waves (wave 2: 395/480, 82.3% vs 790/1037, 76.18%; wave 3: 366/480, 76.3% vs 729/1037, 70.30%). Substance use prevalence in this cohort was similar to national and state-level surveillance estimates for young adults, but was lower than state-level surveillance estimates for youth. Most participants retained at wave 3 provided positive qualitative feedback on their experience.
CONCLUSIONS
Our study supports the feasibility of recruiting a web-based cohort of youth and young adults with representation across an entire state to evaluate substance use prevention efforts. Findings suggest that a guaranteed payment immediately upon survey completion coupled with a bonus for completing all survey waves and weekly survey reminders may facilitate retention in a cohort of youth and young adults.",2020,Retention was 78.11% (1185/1517) at 3 months and 72.18% (1095/1517) at 6 months.,"['Eligible participants were Vermont residents aged 12 to 25 years who were willing to complete three 10 to 15-minute web-based surveys over a 6-month period', '480 eligible youth (aged 12-17 years) and 1037 eligible young adults (aged 18-25 years) to the Policy and Communication Evaluation (PACE) Vermont Study']","['retention incentive conditions: (1) guaranteed incentive (US $10), (2) lottery incentive (US $50 weekly lottery drawing), and (3) preferred method (guaranteed or lottery']",['Retention'],"[{'cui': 'C0042537', 'cui_str': 'Vermont'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.157918,Retention was 78.11% (1185/1517) at 3 months and 72.18% (1095/1517) at 6 months.,"[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Villanti', 'Affiliation': 'Department of Psychiatry, Vermont Center on Behavior and Health, University of Vermont Larner College of Medicine, Burlington, VT, United States.'}, {'ForeName': 'Christie P', 'Initials': 'CP', 'LastName': 'Vallencourt', 'Affiliation': 'Health Promotion & Disease Prevention, Vermont Department of Health, Burlington, VT, United States.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'West', 'Affiliation': 'Department of Psychiatry, Vermont Center on Behavior and Health, University of Vermont Larner College of Medicine, Burlington, VT, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Peasley-Miklus', 'Affiliation': 'Department of Psychiatry, Vermont Center on Behavior and Health, University of Vermont Larner College of Medicine, Burlington, VT, United States.'}, {'ForeName': 'S Elisha', 'Initials': 'SE', 'LastName': 'LePine', 'Affiliation': 'Department of Psychiatry, Vermont Center on Behavior and Health, University of Vermont Larner College of Medicine, Burlington, VT, United States.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'McCluskey', 'Affiliation': 'Department of Psychiatry, Vermont Center on Behavior and Health, University of Vermont Larner College of Medicine, Burlington, VT, United States.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Klemperer', 'Affiliation': 'Department of Psychiatry, Vermont Center on Behavior and Health, University of Vermont Larner College of Medicine, Burlington, VT, United States.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Priest', 'Affiliation': 'Biomedical Statistics Research Core, University of Vermont, Burlington, VT, United States.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Logan', 'Affiliation': 'Hark Inc, Burlington, VT, United States.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Patton', 'Affiliation': 'Hark Inc, Burlington, VT, United States.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Erickson', 'Affiliation': 'Communication, Vermont Department of Health, Burlington, VT, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hicks', 'Affiliation': 'Health Surveillance, Vermont Department of Health, Burlington, VT, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Horton', 'Affiliation': 'Communication, Vermont Department of Health, Burlington, VT, United States.'}, {'ForeName': 'Shayla', 'Initials': 'S', 'LastName': 'Livingston', 'Affiliation': 'Public Health Policy, Vermont Department of Health, Burlington, VT, United States.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Roemhildt', 'Affiliation': 'Health Surveillance, Vermont Department of Health, Burlington, VT, United States.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Singer', 'Affiliation': 'Health Promotion & Disease Prevention, Vermont Department of Health, Burlington, VT, United States.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Trutor', 'Affiliation': 'Alcohol & Drug Abuse Programs, Vermont Department of Health, Burlington, VT, United States.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Health Promotion & Disease Prevention, Vermont Department of Health, Burlington, VT, United States.'}]",Journal of medical Internet research,['10.2196/18446']
2426,32706692,Internet-Based Self-Management Support After High-Altitude Climate Treatment for Severe Asthma: Randomized Controlled Trial.,"BACKGROUND
In patients with severe asthma, high-altitude climate treatment has been shown to improve asthma control. However, asthma symptoms and limitations may increase after finishing inpatient rehabilitation programs and returning to sea level.
OBJECTIVE
We assessed the effectiveness of a patient-tailored, internet-based, self-management strategy in addition to usual care after finishing high-altitude climate treatment.
METHODS
We performed a randomized controlled trial with a 1-year follow-up in patients from a high-altitude asthma center in Davos, Switzerland. At the end of a 12-week multidisciplinary rehabilitation program, 62 adults with asthma were randomized to receive either internet-based self-management support in addition to usual care (n=33) or usual care only after discharge (n=29). The endpoints were changes in asthma-related quality of life according to the Asthma Quality of Life Questionnaire (AQLQ) (a higher score is better) and asthma control according to the Asthma Control Questionnaire (ACQ) (a lower score is better), with a minimally important difference of 0.5 points for both.
RESULTS
Asthma-related quality of life and asthma control declined over time in the usual care strategy group, whereas there was a slower decline in the internet-based strategy group. For both endpoints, mixed-model analysis showed a significant positive effect in favor of internet-based self-management during follow-up (mean AQLQ score difference 0.39, 95% CI 0.092-0.69; P=.01 and ACQ score difference -0.50, 95% CI -0.86 to -0.15; P=.006), which was prominent among patients with uncontrolled asthma at discharge (AQLQ score difference 0.59, 95% CI 0.19-0.99; P=.003 and ACQ score difference -0.73, 95% CI -1.18 to -0.28; P=.002).
CONCLUSIONS
Internet-based self-management support was associated with a smaller decline in quality of life and asthma control as compared with usual care, especially in patients with lower asthma control, after completion of high-altitude climate treatment. Internet-based self-management support in adults with severe asthma seems feasible and effective to maintain quality of life and asthma control.
TRIAL REGISTRATION
The trial is registered in the Netherlands Trial Register (NTR1995).",2020,"Internet-based self-management support in adults with severe asthma seems feasible and effective to maintain quality of life and asthma control.
","['patients from a high-altitude asthma center in Davos, Switzerland', 'Severe Asthma', 'adults with severe asthma', '62 adults with asthma', 'patients with severe asthma']","['internet-based self-management support in addition to usual care (n=33) or usual care only after discharge', 'Internet-Based Self-Management Support', 'Internet-based self-management support']","['quality of life and asthma control', 'Asthma-related quality of life and asthma control', 'changes in asthma-related quality of life according to the Asthma Quality of Life Questionnaire (AQLQ) (a higher score is better) and asthma control according to the Asthma Control Questionnaire (ACQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}]",62.0,0.119011,"Internet-based self-management support in adults with severe asthma seems feasible and effective to maintain quality of life and asthma control.
","[{'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'Beerthuizen', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Lucia H', 'Initials': 'LH', 'LastName': 'Rijssenbeek-Nouwens', 'Affiliation': 'Dutch Asthma Centre Davos, Davos, Switzerland.'}, {'ForeName': 'Sophia M', 'Initials': 'SM', 'LastName': 'van Koppen', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Rishi J', 'Initials': 'RJ', 'LastName': 'Khusial', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Jiska B', 'Initials': 'JB', 'LastName': 'Snoeck-Stroband', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Jacob K', 'Initials': 'JK', 'LastName': 'Sont', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, Netherlands.'}]",Journal of medical Internet research,['10.2196/13145']
2427,32716299,An mHealth Intervention (ReZone) to Help Young People Self-Manage Overwhelming Feelings: Cluster-Randomized Controlled Trial.,"BACKGROUND
Mental health difficulties in young people are increasing, and there is a need for evidence on the effectiveness of digital interventions to increase opportunities for supporting mental health in young people. Such studies are complicated due to issues of implementation and adoption, outcome measurement, and appropriate study designs.
OBJECTIVE
The objective of this study was to examine the effectiveness of an mHealth intervention (ReZone) in reducing mental health difficulties in young people.
METHODS
The cluster-randomized controlled trial enrolled 409 participants aged 10-15 years, and classes were allocated to ReZone or management as usual. Self-reported questionnaires were completed at baseline and 3-month follow-up.
RESULTS
There were no significant differences between the ReZone condition and management as usual in the self-reported outcome measures. However, there were 3467 usage sessions, which corresponds to 16.9 times per student (total of 205 students) in classes allocated to ReZone.
CONCLUSIONS
It is essential to publish studies that do not show significant differences, as these findings can still contribute to the literature, help in learning, and inform the direction of future work. The results reported in this paper could be due to a range of reasons, including whether ReZone has the scope to impact change or limitations related to the setting, context, and appropriateness of an RCT. The findings of this study suggest that ReZone was implemented and adopted.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.2196/resprot.7019.",2020,There were no significant differences between the ReZone condition and management as usual in the self-reported outcome measures.,"['Young People', 'young people', '409 participants aged 10-15 years, and classes']","['mHealth Intervention (ReZone', 'mHealth intervention (ReZone']",['mental health difficulties'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",409.0,0.0945038,There were no significant differences between the ReZone condition and management as usual in the self-reported outcome measures.,"[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Edridge', 'Affiliation': 'Clinical, Educational and Health Psychology, University College London, London, United Kingdom.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Wolpert', 'Affiliation': 'Clinical, Educational and Health Psychology, University College London, London, United Kingdom.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Deighton', 'Affiliation': 'Clinical, Educational and Health Psychology, University College London, London, United Kingdom.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Edbrooke-Childs', 'Affiliation': 'Clinical, Educational and Health Psychology, University College London, London, United Kingdom.'}]",Journal of medical Internet research,['10.2196/14223']
2428,32712034,Pragmatic Randomized Controlled Pilot Trial on Trigger Point Injections With 1% Lidocaine Versus Conventional Approaches for Myofascial Pain in the Emergency Department.,"BACKGROUND
Myofascial neck and back pain is an increasingly common chief symptom in the emergency department. Currently, there are no widely accepted conventional therapies, and there is little evidence on the efficacy of interventions such as trigger point injections (TPIs).
OBJECTIVE
This study evaluates whether TPIs with 1% lidocaine can improve myofascial back and neck pain compared with conventional therapies. Secondary outcomes include changes in length of stay and number of opioid prescriptions on discharge.
METHODS
This single-center, prospective, randomized, pragmatic trial was carried out in patients clinically determined to have myofascial back or neck pain. Patients were randomized into the experimental arm (TPI with 1% lidocaine) or the control arm (standard conventional approach). Numeric Rating Scores (NRS) for pain and additional surveys were obtained prior to and 20 min after the intervention.
RESULTS
The NRS for pain was lower in the TPI group compared with the control group after adjustment for initial pain (median difference -3.01; 95% confidence interval -4.20 to -1.83; p < 0.001). Median length of stay was 2.61 h for the TPI group and 4.63 h for the control group (p < 0.001). More patients in the control group (47.4%) were discharged home with an opioid compared with the TPI group (2.9%) (p < 0.001).
CONCLUSIONS
TPI is an effective method for managing myofascial pain in the emergency department. This study indicates it may improve pain compared with conventional methods, reduce length of stay in the emergency department, and reduce opioid prescriptions on discharge.",2020,Median length of stay was 2.61 h for the TPI group and 4.63 h for the control group (p < 0.001).,['patients clinically determined to have myofascial back or neck pain'],"['Lidocaine', 'TPIs with 1% lidocaine', 'lidocaine']","['changes in length of stay and number of opioid prescriptions on discharge', 'Numeric Rating Scores (NRS) for pain and additional surveys', 'myofascial pain', 'myofascial back and neck pain', 'NRS for pain', 'pain', 'Myofascial Pain', 'Median length of stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0185340', 'cui_str': 'Injection of trigger points'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.172924,Median length of stay was 2.61 h for the TPI group and 4.63 h for the control group (p < 0.001).,"[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Yanuck', 'Affiliation': 'Department of Emergency Medicine, University of California, Irvine, Orange, California; Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Saadat', 'Affiliation': 'Department of Emergency Medicine, University of California, Irvine, Orange, California.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, University of California, Irvine, Orange, California.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Jen', 'Affiliation': 'Department of Emergency Medicine, University of California, Irvine, Orange, California.'}, {'ForeName': 'Bharath', 'Initials': 'B', 'LastName': 'Chakravarthy', 'Affiliation': 'Department of Emergency Medicine, University of California, Irvine, Orange, California.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.06.015']
2429,32715744,"The effectiveness of pulsed ultrasound treatment on pain, function, synovial sac thickness and femoral cartilage thickness in patients with knee osteoarthritis: a randomized, double-blind clinical, controlled study.","OBJECTIVE
This study aims to investigate the efficacy of therapeutic pulsed ultrasound on pain, function, synovial sac and femoral cartilage in knee osteoarthritis.
DESIGN
Randomized, double-blind, controlled study.
SETTING
Dokuz Eylul University, Department of Physical Medicine and Rehabilitation.
SUBJECTS
A total of 96 patients with knee osteoarthritis.
INTERVENTIONS
Participants were randomized into two groups; Group I ( n = 48, pulsed ultrasound) and Group II ( n = 48, sham ultrasound). The sessions were held three times a week for 8 weeks. The study continued for 12 weeks (with 4 weeks follow-up). All participants performed exercises at home for 12 weeks.
MAIN MEASURES
Knee pain (at rest and ADLs) was assessed using the visual analog scale (VAS). Functionality was assessed using the Timed Up and Go test and Western Ontario and McMaster Universities Osteoarthritis (WOMAC) questionnaire. Femoral cartilage and synovial sac thickness was measured using ultrasonography. All evaluations were performed at the baseline, at the 8 and 12 weeks after baseline.
RESULTS
The study was completed with a total of 75 patients ( n = 39 in group I and n = 36 in group II). The mean (SD) pain at ADLs score at baseline and week 12 was 7.2 (2.1), with 3.6 (2.9) in the group I, and 6.7 (2.0) and 4.3 (2.2) in the group II, respectively. Both groups presented significant improvements in terms of pain and function ( P < 0.001). There was no difference between groups for any parameters.
CONCLUSION
Treatment of pulsed ultrasound has no positive effect on knee pain, function, femoral cartilage and synovial sac thickness in knee osteoarthritis.",2020,"Treatment of pulsed ultrasound has no positive effect on knee pain, function, femoral cartilage and synovial sac thickness in knee osteoarthritis.","['96 patients with knee osteoarthritis', '75 patients ( n = 39 in group I and n = 36 in group II', 'knee osteoarthritis', 'Dokuz Eylul University, Department of Physical Medicine and Rehabilitation', 'patients with knee osteoarthritis']","['pulsed ultrasound', 'therapeutic pulsed ultrasound', 'pulsed ultrasound treatment']","['pain, function, synovial sac and femoral cartilage', 'mean (SD) pain at ADLs score', 'visual analog scale (VAS', 'Femoral cartilage and synovial sac thickness', 'knee pain, function, femoral cartilage and synovial sac thickness', 'pain and function', 'pain, function, synovial sac thickness and femoral cartilage thickness', 'Timed Up and Go test and Western Ontario and McMaster Universities Osteoarthritis (WOMAC) questionnaire', 'Knee pain (at rest and ADLs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}]","[{'cui': 'C2143225', 'cui_str': 'Pulsed Ultrasound'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443144', 'cui_str': 'At rest'}]",96.0,0.0768472,"Treatment of pulsed ultrasound has no positive effect on knee pain, function, femoral cartilage and synovial sac thickness in knee osteoarthritis.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Karakaş', 'Affiliation': 'Department of Rheumatology, Physical Medicine and Rehabilitation, Dokuz Eylül University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Dilek', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Dokuz Eylül University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'M Abdulkerim', 'Initials': 'MA', 'LastName': 'Şahin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Dokuz Eylül University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Hülya', 'Initials': 'H', 'LastName': 'Ellidokuz', 'Affiliation': 'Department of Preventive Oncology, Institute of Oncology, Dokuz Eylül University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Şenocak', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Dokuz Eylül University School of Medicine, Izmir, Turkey.'}]",Clinical rehabilitation,['10.1177/0269215520942953']
2430,32706660,Combination of 3-Dimensional Virtual Reality and Hands-On Aromatherapy in Improving Institutionalized Older Adults' Psychological Health: Quasi-Experimental Study.,"BACKGROUND
In Taiwan, which has one of the most rapidly aging populations in the world, it is becoming increasingly critical to promote successful aging strategies that are effective, easily usable, and acceptable to institutionalized older adults. Although many practitioners and professionals have explored aromatherapy and identified its psychological benefits, the effectiveness of combining 3-dimensional (3D) virtual reality and hands-on aromatherapy remains unknown.
OBJECTIVE
A quasi-experimental trial was designed to evaluate the effectiveness of this combination in lowering perceived stress and promoting happiness, sleep quality, meditation experience, and life satisfaction among institutionalized older adults in Taiwan.
METHODS
A total of 60 institutionalized elderly participants either received the combined intervention or were in a control group. Weekly 2-hour sessions were implemented over 9 weeks. The outcome variables were happiness, perceived stress, sleep quality, meditation experience, and life satisfaction, which were assessed at baseline and after the intervention.
RESULTS
Generalized estimating equation (GEE) analyses indicated that the experimental group showed significant post-intervention improvements in terms of scores for happiness, perceived stress, sleep quality, meditation experience, and life satisfaction (n=48; all P<.001). Another GEE analysis showed that the significant improvements in the 5 outcome variables persisted in participants aged 80 years and older (n=35; all P<.001).
CONCLUSIONS
This is the first trial to explore the effectiveness of a combination of 3D virtual reality and hands-on aromatherapy in improving older adults' psychological health. The results are promising for the promotion of psychological health in institutionalized older adults.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04324216; https://clinicaltrials.gov/ct2/show/NCT04324216.",2020,"RESULTS
Generalized estimating equation (GEE) analyses indicated that the experimental group showed significant post-intervention improvements in terms of scores for happiness, perceived stress, sleep quality, meditation experience, and life satisfaction (n=48; all P<.001).","['institutionalized older adults in Taiwan', '60 institutionalized elderly participants', ""older adults' psychological health"", 'participants aged 80 years and older (n=35; all P<.001', 'institutionalized older adults', ""Institutionalized Older Adults' Psychological Health""]","['3-Dimensional Virtual Reality and Hands', 'Aromatherapy', '3D virtual reality and hands-on aromatherapy', 'combined intervention']","['scores for happiness, perceived stress, sleep quality, meditation experience, and life satisfaction', 'lowering perceived stress and promoting happiness, sleep quality, meditation experience, and life satisfaction', 'happiness, perceived stress, sleep quality, meditation experience, and life satisfaction']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]",60.0,0.0374316,"RESULTS
Generalized estimating equation (GEE) analyses indicated that the experimental group showed significant post-intervention improvements in terms of scores for happiness, perceived stress, sleep quality, meditation experience, and life satisfaction (n=48; all P<.001).","[{'ForeName': 'Vivian Ya-Wen', 'Initials': 'VY', 'LastName': 'Cheng', 'Affiliation': 'PureAroma Healing Academy, Taipei, Taiwan.'}, {'ForeName': 'Chiu-Mieh', 'Initials': 'CM', 'LastName': 'Huang', 'Affiliation': 'Institute of Clinical Nursing, School of Nursing, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Jung-Yu', 'Initials': 'JY', 'LastName': 'Liao', 'Affiliation': 'Institute of Population Health sciences, National Health Research Institutes, Miaoli, Taiwan.'}, {'ForeName': 'Hsiao-Pei', 'Initials': 'HP', 'LastName': 'Hsu', 'Affiliation': 'Institute of Clinical Nursing, School of Nursing, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Wen', 'Initials': 'SW', 'LastName': 'Wang', 'Affiliation': 'Department of Health Promotion and Health Education, College of Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Su-Fei', 'Initials': 'SF', 'LastName': 'Huang', 'Affiliation': 'Department of Senior Citizen Service, Mackay Junior College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Jong-Long', 'Initials': 'JL', 'LastName': 'Guo', 'Affiliation': 'Department of Health Promotion and Health Education, College of Education, National Taiwan Normal University, Taipei, Taiwan.'}]",Journal of medical Internet research,['10.2196/17096']
2431,32715946,Validation of equations to estimate the peak oxygen uptake in adolescents from 20 metres shuttle run test.,"This study aimed to develop new prediction models from directly determined peak of oxygen uptake (VO 2peak ) in adolescents using 20-metre shuttle run test (20 m-SR) and to compare the new models with previously published equations. This study included 148 adolescents (43% girls), aged 13.37 ± 1.84 years old. Adolescents were randomly assigned to validation (n = 91) and cross-validation (n = 57) groups. VO 2peak was measured using a gas analyser in both maximal exercise tests in the laboratory as well as by 20 m-SR. The multiple linear regression method was applied to develop the models using BMI, BMI-z score and body fat percentage (%FM). The proposed models presented better predictive performance (R2 = 75.6% to 78.9%) and a lower absolute percentage error (%error = 10.51 to 11.78%) than the previously published equations (R2 = 38.8% to 69.1%; %error = 13.13% to 21.54%). The Model with BMI-z was the best fit equation in girls, and the model with BMI-z and %FM in boys. Therefore, it is recommended that the equations developed in the present study be used in future research and projects in the school environment to estimate VO 2peak in adolescents by the 20 m-SR test.",2020,The proposed models presented better predictive performance (R2 = 75.6% to 78.9%) and a lower absolute percentage error (%error = 10.51 to 11.78%) than the previously published equations (R2 = 38.8% to 69.1%; %error = 13.13% to 21.54%).,"['adolescents using 20-metre shuttle run test (20 m-SR', 'Adolescents', '148 adolescents (43% girls), aged 13.37\xa0±\xa01.84\xa0years old', 'adolescents from 20 metres shuttle run test']",[],"['VO 2peak', 'peak oxygen uptake', 'oxygen uptake (VO 2peak ']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0475209', 'cui_str': 'meter'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",148.0,0.015017,The proposed models presented better predictive performance (R2 = 75.6% to 78.9%) and a lower absolute percentage error (%error = 10.51 to 11.78%) than the previously published equations (R2 = 38.8% to 69.1%; %error = 13.13% to 21.54%).,"[{'ForeName': 'Francisco José de', 'Initials': 'FJ', 'LastName': 'Menezes-Junior', 'Affiliation': 'Department of Physical Education, Federal University of Paraná , Curitiba, Brazil.'}, {'ForeName': 'Íncare Correa de', 'Initials': 'ÍC', 'LastName': 'Jesus', 'Affiliation': 'Department of Physical Education, Federal University of Paraná , Curitiba, Brazil.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Mota', 'Affiliation': 'Department of Centro de Investigação em Actividade Fìsica, Saúde e Lazer (CIAFEL), University of Porto , Porto, Portugal.'}, {'ForeName': 'Maria de Fatima Aguiar', 'Initials': 'MFA', 'LastName': 'Lopes', 'Affiliation': 'Department of Physical Education, Federal University of Paraná , Curitiba, Brazil.'}, {'ForeName': 'Patricia Ribeiro Paes', 'Initials': 'PRP', 'LastName': 'Corazza', 'Affiliation': 'Department of Physical Education, Federal University of Paraná , Curitiba, Brazil.'}, {'ForeName': 'Maiara Cristina', 'Initials': 'MC', 'LastName': 'Tadiotto', 'Affiliation': 'Department of Physical Education, Federal University of Paraná , Curitiba, Brazil.'}, {'ForeName': 'Tatiana Aparecida Affornali', 'Initials': 'TAA', 'LastName': 'Tozo', 'Affiliation': 'Department of Physical Education, Federal University of Paraná , Curitiba, Brazil.'}, {'ForeName': 'Kátia Sheylla Malta', 'Initials': 'KSM', 'LastName': 'Purim', 'Affiliation': 'Area of Teaching, Positive University , Curitiba, Brazil.'}, {'ForeName': 'Enio Ricardo Vaz', 'Initials': 'ERV', 'LastName': 'Ronque', 'Affiliation': 'Department of Physical Education, State University of Londrina , Londrina, Brazil.'}, {'ForeName': 'Neiva', 'Initials': 'N', 'LastName': 'Leite', 'Affiliation': 'Department of Physical Education, Federal University of Paraná , Curitiba, Brazil.'}]",Journal of sports sciences,['10.1080/02640414.2020.1794255']
2432,32711957,Thermoregulatory responses to ice slurry ingestion during low and moderate intensity exercises with restrictive heat loss.,"OBJECTIVES
We investigated the thermoregulatory responses to ice slurry ingestion during low- and moderate-intensity exercises with restrictive heat loss.
DESIGN
Randomised, counterbalanced, cross-over design.
METHODS
Following a familiarisation trial, ten physically active males exercised on a motorised treadmill at low-intensity (L; 40% VO 2max ) or moderate-intensity (M; 70% VO 2max ) for 75-min, in four randomised, counterbalanced trials. Throughout the exercise bout, participants donned a raincoat to restrict heat loss. Participants ingested 2gkg -1 body mass of ambient water (L+AMB and M+AMB trials) or ice slurry (L+ICE and M+ICE trials) at 15-min intervals during exercise in environmental conditions of T db, 25.1±0.6°C and RH, 63±5%. Heart rate (HR), gastrointestinal temperature (T gi ), mean weighted skin temperature (T sk ), estimated sweat loss, ratings of perceived exertion (RPE) and thermal sensation (RTS) were recorded.
RESULTS
Compared to L+AMB, participants completed L+ICE trials with lower ΔT gi (0.8±0.3°C vs 0.6±0.2°C; p=0.03), mean RPE (10±1 vs 9±1; p=0.03) and estimated sweat loss (0.91±0.2L vs 0.78±0.27L; p=0.04). Contrastingly, T gi (p=0.22), T sk (p=0.37), HR (p=0.31), RPE (p=0.38) and sweat loss (p=0.17) were similar between M+AMB and M+ICE trials. RTS was similar during both low-intensity (4.9±0.5 vs 4.7±0.3; p=0.10) and moderate-intensity exercise (5.3±0.47 vs 5.0±0.4; p=0.09).
CONCLUSIONS
Per-cooling using ice slurry ingestion marginally reduced thermal strain during low-intensity but not during moderate-intensity exercise. Ice slurry may be an effective and practical heat mitigation strategy during low-intensity exercise such as in occupational and military settings, but a greater volume should be considered to ensure its efficacy.",2020,"Ice slurry may be an effective and practical heat mitigation strategy during low-intensity exercise such as in occupational and military settings, but a greater volume should be considered to ensure its efficacy.","['Following a familiarisation trial, ten physically active males exercised on a']",['motorised treadmill at low-intensity (L; 40% VO 2max ) or moderate-intensity (M; 70% VO 2max '],"['mean RPE', 'estimated sweat loss', 'RTS', 'moderate-intensity exercise', 'thermal strain', 'Heart rate (HR), gastrointestinal temperature (T gi ), mean weighted skin temperature (T sk ), estimated sweat loss, ratings of perceived exertion (RPE) and thermal sensation (RTS', 'sweat loss', 'RPE']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}]",10.0,0.135853,"Ice slurry may be an effective and practical heat mitigation strategy during low-intensity exercise such as in occupational and military settings, but a greater volume should be considered to ensure its efficacy.","[{'ForeName': 'Sharifah B', 'Initials': 'SB', 'LastName': 'Alhadad', 'Affiliation': 'NUS Graduate School for Integrative Sciences and Engineering, National University of Singapore, Singapore; Department of Physiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Ivan C C', 'Initials': 'ICC', 'LastName': 'Low', 'Affiliation': 'Department of Physiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Jason K W', 'Initials': 'JKW', 'LastName': 'Lee', 'Affiliation': 'Department of Physiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Global Asia Institute, National University of Singapore, Singapore; N.1 Institute for Health, National University of Singapore, Singapore. Electronic address: phsjlkw@nus.edu.sg.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.07.002']
2433,32716320,Blinded SAPS-PD Assessment After 10 Weeks of Pimavanserin Treatment for Parkinson's Disease Psychosis.,"BACKGROUND
Parkinson's disease psychosis (PDP) is a common nonmotor symptom that affects up to 60% of patients. Pimavanserin, a selective 5-HT2A inverse agonist/antagonist, is approved for treating hallucinations and delusions associated with PDP.
OBJECTIVE
Evaluate the efficacy and tolerability of pimavanserin in an open-label extension (OLE) study.
METHODS
Patients completing a pivotal 6-week placebo-controlled trial (Core Study) could enroll in the OLE. All patients pimavanserin 34 mg once daily, blinded to previous treatment allocation. Prespecified blinded assessments at Week 4 were the Scale for the Assessment of Positive Symptoms (SAPS) PD version and SAPS H + D scales, Caregiver Burden Scale (CBS), and Clinical Global Impression (CGI) Improvement and Severity scales.
RESULTS
Of 171 who entered the OLE, 148 (87%) completed Week 4. Among patients who received placebo in the Core Study, mean (SD) change from OLE baseline to OLE Week 4 for the SAPS-PD was - 3.4 (6.3); p < 0.0001. Mean change from Core Study baseline to OLE Week 4 for SAPS-PD was similar among prior pimavanserin- and placebo-treated patients (-6.9 vs. -6.3). Improvement was similar with CGI-I, CGI-S, CBS, and SAPS-H + D in patients previously treated with placebo. Adverse events occurred in 92 (53.8%) patients during the 4-week OLE.
CONCLUSION
Improvements at OLE Week 4 from pretreatment baseline were similar with placebo and pimavanserin in the Core Study. The beneficial effects observed with pimavanserin in the 6-week Core Study were maintained for 4 weeks in the blinded OLE, supporting the durability of response with pimavanserin 34 mg for PDP over 10 weeks.",2020,Mean change from Core Study baseline to OLE Week 4 for SAPS-PD was similar among prior pimavanserin- and placebo-treated patients (-6.9 vs. -6.3).,"[""Parkinson's Disease Psychosis"", 'Of 171 who entered the OLE, 148 (87%) completed Week 4', ""Parkinson's disease psychosis (PDP"", 'Patients completing a pivotal 6-week']","['pimavanserin- and placebo', 'SAPS-PD Assessment', 'pimavanserin', 'Pimavanserin', 'placebo']","['Adverse events', 'Positive Symptoms (SAPS', 'PD version and SAPS H\u200a+\u200aD scales, Caregiver Burden Scale (CBS), and Clinical Global Impression (CGI) Improvement and Severity scales', 'efficacy and tolerability']","[{'cui': 'C3805119', 'cui_str': ""Parkinson's disease psychosis""}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1722267', 'cui_str': 'pimavanserin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.183307,Mean change from Core Study baseline to OLE Week 4 for SAPS-PD was similar among prior pimavanserin- and placebo-treated patients (-6.9 vs. -6.3).,"[{'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA.""}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Coate', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Norton', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}]",Journal of Parkinson's disease,['10.3233/JPD-202047']
2434,32717127,Effect of a Structured Teaching Module Including Intensive Prophylactic Measures on Reducing the Incidence of Capecitabine-Induced Hand-Foot Syndrome: Results of a Prospective Randomized Phase III Study.,"LESSONS LEARNED
A structured teaching module including intensive prophylactic measures to alleviate hand-foot syndrome (HFS) during capecitabine therapy is feasible but ineffective at protecting patients from HFS. Pharmacologic therapeutic interventions should be investigated for the management of this complication.
BACKGROUND
Capecitabine-induced hand-foot syndrome (HFS) has a detrimental effect on quality of life. The effect of a structured teaching module including intensive prophylactic measures was evaluated.
METHODS
This non-crossover phase III double-blinded clinical trial randomized patients in a 1:1 ratio to either a control group or to a group administered a structured teaching model including intensive prophylactic measures on HFS administered by a trained oncology nurse at regular intervals (case) versus standard information on HFS care administered by treating clinician (control). The primary endpoint was comparison of fraction of patients in both arms developing at least grade 2 HFS.
RESULTS
Between June 15, 2016, and April 4, 2018, 280 patients (140 to case and 140 to control) were enrolled. The median number of capecitabine chemotherapy cycles was eight; 269 patients (96%) were evaluable for HFS, of whom 89 patients (33.08%) developed at least grade 2 HFS (grade 2 HFS, 73 patients [26.1%]; grade 3 HFS, 16 patients (5.7%}). There was no difference in at least grade 2 HFS between evaluable case and control arms of the study (control group, 45/135 [33.3%]; case, 44/134 [32.8%]; p = .93).
CONCLUSION
The use of a structured teaching module including intensive prophylactic measures was feasible, but this did not reduce the incidence and severity of capecitabine-induced HFS.",2020,"There was no difference in at least grade 2 HFS between evaluable case and control arms of the study [control group - 45/135 (33.3%); case - 44/134 (32.8%); p = .93].
","['Between June 15, 2016 and April 4 2018, 280 patients (140 to case and 140 to control) were enrolled']","['structured teaching module', 'Structured Teaching Module', 'structured teaching model including intensive prophylactic measures on HFS administered by a trained oncology nurse at regular intervals (case) versus standard information on HFS care administered by treating clinician (control', 'capecitabine therapy']","['quality of life', 'median number of capecitabine chemotherapy cycles', 'comparison of fraction of patients in both arms developing at least grade 2 HFS', 'Incidence of Capecitabine-Induced Hand-Foot Syndrome']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557529', 'cui_str': 'Oncology nurse'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",,0.0958387,"There was no difference in at least grade 2 HFS between evaluable case and control arms of the study [control group - 45/135 (33.3%); case - 44/134 (32.8%); p = .93].
","[{'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Ostwal', 'Affiliation': 'Medical Oncology Department, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Akhil', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Sarika', 'Initials': 'S', 'LastName': 'Mandavkar', 'Affiliation': 'Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Chavan', 'Affiliation': 'Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Tarachand', 'Initials': 'T', 'LastName': 'Gupta', 'Affiliation': 'Apex Hospitals, Jaipur, Rajasthan, India.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Mirani', 'Affiliation': 'Wochardt Hospitals, Mumbai, India.'}, {'ForeName': 'Avanish', 'Initials': 'A', 'LastName': 'Saklani', 'Affiliation': 'Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Desouza', 'Affiliation': 'Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Kalaivani', 'Initials': 'K', 'LastName': 'Murugan', 'Affiliation': 'Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Chaitali', 'Initials': 'C', 'LastName': 'Nashikkar', 'Affiliation': 'Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Sudeep', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Advanced Centre for Treatment, Research and Education in Cancer, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Ramaswamy', 'Affiliation': 'Tata Memorial Centre, Mumbai, India.'}]",The oncologist,['10.1634/theoncologist.2020-0698']
2435,32711554,BRCAness digitalMLPA profiling predicts benefit of intensified platinum-based chemotherapy in triple-negative and luminal-type breast cancer.,"BACKGROUND
We previously showed that BRCA-like profiles can be used to preselect individuals with the highest risk of carrying BRCA mutations but could also indicate which patients would benefit from double-strand break inducing chemotherapy. A simple, robust, and reliable assay for clinical use that utilizes limited amounts of formalin-fixed, paraffin-embedded tumor tissue to assess BRCAness status in both ER-positive and ER-negative breast cancer (BC) is currently lacking.
METHODS
A digital multiplex ligation-dependent probe amplification (digitalMLPA) assay was designed to detect copy number alterations required for the classification of BRCA1-like and BRCA2-like BC. The BRCA1-like classifier was trained on 71 tumors, enriched for triple-negative BC; the BRCA2-like classifier was trained on 55 tumors, enriched for luminal-type BC. A shrunken centroid-based classifier was developed and applied on an independent validation cohort. A total of 114 cases of a randomized controlled trial were analyzed, and the association of the classifier result with intensified platinum-based chemotherapy response was assessed.
RESULTS
The digitalMLPA BRCA1-like classifier correctly classified 91% of the BRCA1-like samples and 82% of the BRCA2-like samples. Patients with a BRCA-like tumor derived significant benefit of high-dose chemotherapy (adjusted hazard ratio (HR) 0.12, 95% CI 0.04-0.44) which was not observed in non-BRCA-like patients (HR 0.9, 95% CI 0.37-2.18) (p = 0.01). Analysis stratified for ER status showed borderline significance.
CONCLUSIONS
The digitalMLPA is a reliable method to detect a BRCA1- and BRCA2-like pattern on clinical samples and predicts platinum-based chemotherapy benefit in both triple-negative and luminal-type BC.",2020,The digitalMLPA is a reliable method to detect a BRCA1- and BRCA2-like pattern on clinical samples and predicts platinum-based chemotherapy benefit in both triple-negative and luminal-type BC.,[],"['digital multiplex ligation-dependent probe amplification', 'digitalMLPA', 'intensified platinum-based chemotherapy']",[],[],"[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C3494189', 'cui_str': 'Multiplex Ligation-Dependent Probe Amplification'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]",[],114.0,0.164868,The digitalMLPA is a reliable method to detect a BRCA1- and BRCA2-like pattern on clinical samples and predicts platinum-based chemotherapy benefit in both triple-negative and luminal-type BC.,"[{'ForeName': 'Esther H', 'Initials': 'EH', 'LastName': 'Lips', 'Affiliation': 'Department of Molecular Pathology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. e.lips@nki.nl.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Benard-Slagter', 'Affiliation': 'Department of Oncogenetics, MRC Holland, Amsterdam, The Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Opdam', 'Affiliation': 'Department of Molecular Pathology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Scheerman', 'Affiliation': 'Department of Pathology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Jelle', 'Initials': 'J', 'LastName': 'Wesseling', 'Affiliation': 'Department of Molecular Pathology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'Frans B L', 'Initials': 'FBL', 'LastName': 'Hogervorst', 'Affiliation': 'Department of Pathology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Sabine C', 'Initials': 'SC', 'LastName': 'Linn', 'Affiliation': 'Department of Molecular Pathology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Savola', 'Affiliation': 'Department of Oncogenetics, MRC Holland, Amsterdam, The Netherlands.'}, {'ForeName': 'Petra M', 'Initials': 'PM', 'LastName': 'Nederlof', 'Affiliation': 'Department of Pathology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}]",Breast cancer research : BCR,['10.1186/s13058-020-01313-7']
2436,32717713,"Effect of lifetime antiepileptic drug treatment history on efficacy and tolerability of adjunctive brivaracetam in adults with focal seizures: Post-hoc analysis of a randomized, placebo-controlled trial.","OBJECTIVE
To evaluate the efficacy and tolerability of adjunctive brivaracetam (BRV) in adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs).
METHODS
Post-hoc analysis of data from N01358 (NCT01261325), a randomized, double-blind, placebo (PBO)-controlled Phase III trial evaluating BRV 100 and 200 mg/day in patients ≥16 years of age with uncontrolled focal seizures. Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
RESULTS
764 patients received at least one dose of trial medication (BRV: 503; PBO: 261; Safety Set), of whom 14.3% had 1-2, 20.8% had 3-4, 21.3% had 5-6, and 43.6% had ≥7 lifetime AEDs. In all lifetime AED subgroups, >85% of patients completed the trial. Patients with a higher number of lifetime AEDs had a younger age at epilepsy onset, longer epilepsy duration, and higher baseline seizure frequency. In patients on BRV, 50% responder rates were 49.3%, 44.4%, 47.2% and 27.4% in patients with 1-2 (n = 75), 3-4 (n = 99), 5-6 (n = 108) and ≥7 (n = 219) lifetime AEDs; 75% responder rates were 36.0%, 21.2%, 22.2% and 12.3%. In patients on PBO, 50% responder rates were 35.3%, 25.9%, 20.4% and 15.9% in patients with 1-2 (n = 34), 3-4 (n = 58), 5-6 (n = 54) and ≥7 (n = 113) lifetime AEDs; 75% responder rates were 26.5%, 6.9%, 3.7% and 4.4%. The Kaplan-Meier estimated probability of patients achieving a sustained 50% or 75% response from the first day of treatment was generally higher in patients with a lower number of lifetime AEDs (both in patients on BRV and PBO). In patients on adjunctive BRV, the incidence of drug related treatment-emergent adverse events (TEAEs) was 34.7%, 26.0%, 44.4% and 47.7% in patients with 1-2 (n = 75), 3-4 (n = 100), 5-6 (n = 108) and ≥7 (n = 220) lifetime AEDs; the incidence of discontinuations due to TEAEs was 1.3%, 3.0%, 8.3% and 10.5%.
CONCLUSIONS
This post-hoc analysis suggests a numerically higher response to adjunctive BRV in patients with fewer lifetime AEDs. The lowest response was observed in patients with ≥7 lifetime AEDs, although these patients could also benefit from adjunctive BRV treatment. Patients with fewer lifetime AEDs had lower discontinuation of BRV due to TEAEs.",2020,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","['adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs', 'adults with focal seizures', 'subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs', 'patients ≥16 years of age with uncontrolled focal seizures']","['adjunctive brivaracetam (BRV', 'adjunctive brivaracetam', 'placebo']","['Efficacy and tolerability outcomes', 'responder rates', 'incidence of drug related treatment-emergent adverse events (TEAEs', 'efficacy and tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",764.0,0.103758,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, 6410 Rockledge Drive, Suite 610, Bethesda, MD 20817, USA. Electronic address: kleinp@epilepsydc.com.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McLachlan', 'Affiliation': 'Western University, 339 Windermere Road, London, ON N6A 5A5, Canada. Electronic address: rsmcl@uwo.ca.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Foris', 'Affiliation': 'UCB Pharma, 2060 Winston Park Drive, Suite 401, Oakville, ON L6H 5R7, Canada. Electronic address: kforis@sympatico.ca.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Nondonfaz', 'Affiliation': ""UCB Pharma, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium. Electronic address: xavier.nondonfaz@ucb.com.""}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Dimova', 'Affiliation': 'UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: svetlana.dimova@ucb.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Center, Mara Hospital, Maraweg 21, 33617 Bielefeld, Germany. Electronic address: christian.brandt@mara.de.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106369']
2437,32713772,Effects of a Humanoid Companion Robot on Dementia Symptoms and Caregiver Distress for Residents in Long-Term Care.,"OBJECTIVES
To test the effects of deploying a humanoid companion robot (Kabochan) in comparison with usual care for long-term care facilities' residents with dementia.
DESIGN
A 2-arm, randomized controlled trial with ABAB withdrawal design, lasting 32 weeks. After an 8-week baseline period, Kabochan was introduced in a nonfacilitated, individual approach with experimental-group participants (n = 52) for 8 weeks, then removed for 8 weeks, and then reintroduced for another 8 weeks. The control group (n = 51) received the usual standardized care.
SETTING AND PARTICIPANTS
Seven long-term care facilities in Hong Kong. 103 residents (76% women, 87.2 ± 7.4 years) with a clinical diagnosis of dementia.
MEASURES
Outcome assessments occurred at 5 time points: baseline (week 1) and the end of each phase (weeks 8, 16, 24, and 32). Primary outcomes were assessed with the Neuropsychiatric Inventory Questionnaire (symptom severity and caregiver distress subscales) and the Geriatric Depression Scale; secondary outcomes were measured by the Hong Kong Montreal Cognitive Assessment 5-minute Protocol, the Modified Barthel Index for Activities of Daily Living, and the Quality of Life-Alzheimer's disease scale.
RESULTS
A multivariate analysis of variance indicated a statistically significant group × time interaction for neuropsychiatric-related caregiver distress at week 16 (F = 6.72, P = .011), with a moderate effect size (η p 2 = 0.06). When Kabochan was removed in the withdrawal phase (weeks 17-24), the neuropsychiatric symptoms became more severe at week 24 for the intervention group (F = 4.68, P = .003), although the effect size was small to moderate (η p 2 = 0.04). No statistical between-group differences were found in other health outcomes.
CONCLUSIONS AND IMPLICATIONS
The Kabochan was potentially effective at reducing short-term neuropsychiatric symptoms and relevant caregiver distress for residents with dementia. An individualized care plan with continuous monitoring is required to integrate the humanoid robot into routine dementia care.",2020,The Kabochan was potentially effective at reducing short-term neuropsychiatric symptoms and relevant caregiver distress for residents with dementia.,"['Residents in Long-Term Care', 'residents with dementia', '103 residents (76% women, 87.2\xa0±\xa07.4\xa0years) with a clinical diagnosis of dementia', ""comparison with usual care for long-term care facilities' residents with dementia"", 'Seven long-term care facilities in Hong Kong']","['usual standardized care', 'Humanoid Companion Robot', 'humanoid companion robot (Kabochan', 'Kabochan']","[""Neuropsychiatric Inventory Questionnaire (symptom severity and caregiver distress subscales) and the Geriatric Depression Scale; secondary outcomes were measured by the Hong Kong Montreal Cognitive Assessment 5-minute Protocol, the Modified Barthel Index for Activities of Daily Living, and the Quality of Life-Alzheimer's disease scale"", 'neuropsychiatric symptoms became more severe', 'neuropsychiatric-related caregiver distress', 'Dementia Symptoms and Caregiver Distress']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0336537', 'cui_str': 'Robot'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",103.0,0.0940314,The Kabochan was potentially effective at reducing short-term neuropsychiatric symptoms and relevant caregiver distress for residents with dementia.,"[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Vivian Wei-Qun', 'Initials': 'VW', 'LastName': 'Lou', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong, China; Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong, China. Electronic address: wlou@hku.hk.'}, {'ForeName': 'Kelvin Cheng-Kian', 'Initials': 'KC', 'LastName': 'Tan', 'Affiliation': 'Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong, China.'}, {'ForeName': 'Man-Yi', 'Initials': 'MY', 'LastName': 'Wai', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong, China.'}, {'ForeName': 'Lai-Lok', 'Initials': 'LL', 'LastName': 'Chan', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong, China.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.05.036']
2438,32719981,Assessment of eldecalcitol and alendronate effect on postural balance control in aged women with osteoporosis.,"INTRODUCTION
Older people aged over 75 are more prone to falls because physical functions become deteriorated along with aging, and also fracture risk is strongly correlated with age. We evaluated the effects of anti-osteoporosis agents, eldecalcitol (ELD) and alendronate (ALN) on physical functions by assessing dynamic and static postural balance in aged patients with osteoporosis.
MATERIALS AND METHODS
A randomized, open-label, controlled clinical trial has been conducted with 124 female patients aged 65 or over with osteoporosis. Patients were randomly assigned to receive either 0.75 μg of ELD once-a-day or 35 mg of ALN once-a-week for 24 weeks. The primary endpoint was the change in a postural balance index, adjusted composite equilibrium score (CES) of sensory organization test (SOT). The SOT equilibrium scores, leg muscle strength, and other physical functions were also evaluated.
RESULTS
The Adjusted CES increased from baseline by 6.10% in the ELD group and 6.28% in the ALN group. There was no statistically significant difference between the two groups. The static postural balance at fixed platform were maintained in the ELD group, but declined in the ALN group. The dynamic postural balance at swaying platform and knee extension power increased from baseline in both groups.
CONCLUSIONS
These results suggest that ELD and ALN treatments may each be beneficial to improve postural balance control in older patients with osteoporosis via different mechanisms of action.",2020,"The dynamic postural balance at swaying platform and knee extension power increased from baseline in both groups.
","['aged women with osteoporosis', 'older patients with osteoporosis', 'Older people aged over 75', 'aged patients with osteoporosis', '124 female patients aged 65 or over with osteoporosis']","['anti-osteoporosis agents, eldecalcitol (ELD) and alendronate (ALN', 'ELD once-a-day or 35\xa0mg of ALN', 'eldecalcitol and alendronate', 'ELD', 'ELD and ALN']","['change in a postural balance index, adjusted composite equilibrium score (CES) of sensory organization test (SOT', 'Adjusted CES', 'dynamic postural balance at swaying platform and knee extension power', 'SOT equilibrium scores, leg muscle strength, and other physical functions', 'static postural balance', 'postural balance control']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517553', 'cui_str': '124'}]","[{'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C2828245', 'cui_str': 'eldecalcitol'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1256755', 'cui_str': 'Postural balance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4720873', 'cui_str': 'Sensory organization test'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",124.0,0.0296625,"The dynamic postural balance at swaying platform and knee extension power increased from baseline in both groups.
","[{'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Institute of Gerontology, J. F. Oberlin University, 3758 Tokiwa-machi, Machida, 194-0294, Tokyo, Japan. anant501@obirin.ac.jp.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Harada', 'Affiliation': 'Department of Orthopedic Surgery, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Shimada', 'Affiliation': 'Department of Preventive Gerontology, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Hosoi', 'Affiliation': 'Kenkoin Clinic, Tokyo, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Kawata', 'Affiliation': 'Chugai Pharmaceutical Co. Ltd., Tokyo, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Taisho Pharmaceutical Co. Ltd., Tokyo, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Chugai Pharmaceutical Co. Ltd., Tokyo, Japan.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-020-01118-w']
2439,32720911,The Assessment of Supportive Accountability in Adults Seeking Obesity Treatment: Psychometric Validation Study.,"BACKGROUND
Technology-mediated obesity treatments are commonly affected by poor long-term adherence. Supportive Accountability Theory suggests that the provision of social support and oversight toward goals may help to maintain adherence in technology-mediated treatments. However, no tool exists to measure the construct of supportive accountability.
OBJECTIVE
This study aimed to develop and psychometrically validate a supportive accountability measure (SAM) by examining its performance in technology-mediated obesity treatment.
METHODS
Secondary data analyses were conducted in 2 obesity treatment studies to validate the SAM (20 items). Study 1 examined reliability, criterion validity, and construct validity using an exploratory factor analysis in individuals seeking obesity treatment. Study 2 examined the construct validity of SAM in technology-mediated interventions involving different self-monitoring tools and varying amounts of phone-based interventionist support. Participants received traditional self-monitoring tools (standard, in-home self-monitoring scale [SC group]), newer, technology-based self-monitoring tools (TECH group), or these newer technology tools plus additional phone-based support (TECH+PHONE group). Given that the TECH+PHONE group involves more interventionist support, we hypothesized that this group would have greater supportive accountability than the other 2 arms.
RESULTS
In Study 1 (n=353), the SAM showed strong reliability (Cronbach α=.92). A factor analysis revealed a 3-factor solution (representing Support for Healthy Eating Habits, Support for Exercise Habits, and Perceptions of Accountability) that explained 69% of the variance. Convergent validity was established using items from the motivation for weight loss scale, specifically the social regulation subscale (r=0.33; P<.001) and social pressure for weight loss subscale (r=0.23; P<.001). In Study 2 (n=80), the TECH+PHONE group reported significantly higher SAM scores at 6 months compared with the SC and TECH groups (r 2 =0.45; P<.001). Higher SAM scores were associated with higher adherence to weight management behaviors, including higher scores on subscales representing healthy dietary choices, the use of self-monitoring strategies, and positive psychological coping with weight management challenges. The association between total SAM scores and percent weight change was in the expected direction but not statistically significant (r=-0.26; P=.06).
CONCLUSIONS
The SAM has strong reliability and validity across the 2 studies. Future studies may consider using the SAM in technology-mediated weight loss treatment to better understand whether support and accountability are adequately represented and how supportive accountability impacts treatment adherence and outcomes.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01999244; https://clinicaltrials.gov/ct2/show/NCT01999244.",2020,"Higher SAM scores were associated with higher adherence to weight management behaviors, including higher scores on subscales representing healthy dietary choices, the use of self-monitoring strategies, and positive psychological coping with weight management challenges.","['Adults Seeking Obesity Treatment', 'individuals seeking obesity treatment']","['TECH+PHONE', 'traditional self-monitoring tools (standard, in-home self-monitoring scale [SC group]), newer, technology-based self-monitoring tools (TECH group), or these newer technology tools plus additional phone-based support (TECH+PHONE group']","['total SAM scores and percent weight change', 'Higher SAM scores', 'supportive accountability', 'social regulation subscale', 'SAM scores', 'social pressure for weight loss subscale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0078889', 'cui_str': 'Accountability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0390713,"Higher SAM scores were associated with higher adherence to weight management behaviors, including higher scores on subscales representing healthy dietary choices, the use of self-monitoring strategies, and positive psychological coping with weight management challenges.","[{'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Chhabria', 'Affiliation': 'The Center for Health Care Data, Department of Management, Policy and Community Health, University of Texas Health Science Center at Houston, Houston, TX, United States.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Ross', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Shane J', 'Initials': 'SJ', 'LastName': 'Sacco', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, Storrs, CT, United States.'}, {'ForeName': 'Tricia M', 'Initials': 'TM', 'LastName': 'Leahey', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, Storrs, CT, United States.'}]",Journal of medical Internet research,['10.2196/17967']
2440,32725398,Ultrasound in augmented reality: a mixed-methods evaluation of head-mounted displays in image-guided interventions.,"PURPOSE
Augmented reality (AR) and head-mounted displays (HMD) in medical practice are current research topics. A commonly proposed use case of AR-HMDs is to display data in image-guided interventions. Although technical feasibility has been thoroughly shown, effects of AR-HMDs on interventions are not yet well researched, hampering clinical applicability. Therefore, the goal of this study is to better understand the benefits and limitations of this technology in ultrasound-guided interventions.
METHODS
We used an AR-HMD system (based on the first-generation Microsoft Hololens) which overlays live ultrasound images spatially correctly at the location of the ultrasound transducer. We chose ultrasound-guided needle placements as a representative task for image-guided interventions. To examine the effects of the AR-HMD, we used mixed methods and conducted two studies in a lab setting: (1) In a randomized crossover study, we asked participants to place needles into a training model and evaluated task duration and accuracy with the AR-HMD as compared to the standard procedure without visual overlay and (2) in a qualitative study, we analyzed the user experience with AR-HMD using think-aloud protocols during ultrasound examinations and semi-structured interviews after the task.
RESULTS
Participants (n = 20) placed needles more accurately (mean error of 7.4 mm vs. 4.9 mm, p = 0.022) but not significantly faster (mean task duration of 74.4 s vs. 66.4 s, p = 0.211) with the AR-HMD. All participants in the qualitative study (n = 6) reported limitations of and unfamiliarity with the AR-HMD, yet all but one also clearly noted benefits and/or that they would like to test the technology in practice.
CONCLUSION
We present additional, though still preliminary, evidence that AR-HMDs provide benefits in image-guided procedures. Our data also contribute insights into potential causes underlying the benefits, such as improved spatial perception. Still, more comprehensive studies are needed to ascertain benefits for clinical applications and to clarify mechanisms underlying these benefits.",2020,"RESULTS
Participants (n = 20) placed needles more accurately (mean error of 7.4 mm vs. 4.9 mm, p = 0.022) but not significantly faster (mean task duration of 74.4 s vs. 66.4 ",[],"['AR-HMD using think-aloud protocols during ultrasound examinations and semi-structured interviews after the task', 'ultrasound-guided needle placements', 'place needles into a training model and evaluated task duration and accuracy with the AR-HMD as compared to the standard procedure without visual overlay and (2', 'Augmented reality (AR) and head-mounted displays (HMD', 'AR-HMD']",[],[],"[{'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C5197728', 'cui_str': 'Head Worn Display'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0444456', 'cui_str': 'Overlay'}]",[],,0.0290659,"RESULTS
Participants (n = 20) placed needles more accurately (mean error of 7.4 mm vs. 4.9 mm, p = 0.022) but not significantly faster (mean task duration of 74.4 s vs. 66.4 ","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Rüger', 'Affiliation': 'Department of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Experimental Surgery, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, 13353, Berlin, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Feufel', 'Affiliation': 'Division of Ergonomics, Department of Psychology and Ergonomics (IPA), Technische Universität Berlin, Marchstr. 23, MAR 3-2, 10587, Berlin, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Moosburner', 'Affiliation': 'Department of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Experimental Surgery, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, 13353, Berlin, Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Özbek', 'Affiliation': 'Scopis GmbH, Heinrich-Heine-Platz 10, 10179, Berlin, Germany.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Pratschke', 'Affiliation': 'Department of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Experimental Surgery, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, 13353, Berlin, Germany.'}, {'ForeName': 'Igor M', 'Initials': 'IM', 'LastName': 'Sauer', 'Affiliation': 'Department of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Experimental Surgery, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, 13353, Berlin, Germany. igor.sauer@charite.de.'}]",International journal of computer assisted radiology and surgery,['10.1007/s11548-020-02236-6']
2441,32719231,Comparison of efficacy of potassium titanyl phosphate laser & diode laser in the management of inferior turbinate hypertrophy: A randomized controlled trial.,"Background & objectives
Inferior turbinate hypertrophy (ITH) is a common condition causing nasal obstruction. This study was undertaken to compare the efficacy of potassium titanyl phosphate (KTP) laser and diode laser in the reduction of the turbinate size.
Methods
This randomized controlled trial included 209 patients with ITH. Pre-operative symptoms were assessed based on the Nasal Obstruction Symptom Evaluation (NOSE) score. Diagnostic nasal endoscopy was done to rule out other nasal sinuses. Nasal mucociliary clearance was measured by saccharin transit time (STT). Postoperatively, the NOSE score, STT and complications were assessed at days one and two, at one week, one month and three months.
Results
Of the 209 patients analyzed at day one, the median NOSE score was 50 in the diode group and 40 in the KTP group, and at three months, 15 in the diode group and five in the KTP group. KTP laser showed a 93 per cent improvement in the NOSE score as compared to 77 per cent improvement shown by diode laser group. Among the intra-operative complications, of the 104 patients in the diode group, 6.73 per cent had burning sensation and 91.43 per cent had bleeding, and of 105 patients in the KTP group, 54.29 per cent had burning sensation and 36.54 per cent had bleeding. Among the post-operative complications in the KTP group, 32 and 34 per cent had bloody nasal discharge on days one and two, compared to 12 and 14 per cent in diode group. Crusting was present in 61 and 49 per cent on days one and two in KTP group as compared to 9 and 15 per cent in diode group, respectively. In the KTP group 30 per cent had synechiae as compared to 10 per cent in diode group.
Interpretation & conclusions
KTP laser was more efficacious than diode laser in improving the NOSE scores but with slightly increased rate of complications in early post-operative period. Both the lasers impaired the mucociliary clearance mechanism of the nose till three months of post-operative follow up.",2020,Both the lasers impaired the mucociliary clearance mechanism of the nose till three months of post-operative follow up.,"['209 patients with ITH. Pre-operative symptoms', '209 patients analyzed at day one', 'inferior turbinate hypertrophy']","['Diagnostic nasal endoscopy', 'potassium titanyl phosphate laser & diode laser', 'potassium titanyl phosphate (KTP) laser and diode laser', 'diode laser', 'KTP laser', 'KTP']","['Nasal mucociliary clearance', 'NOSE score', 'saccharin transit time (STT', 'burning sensation', 'NOSE scores', 'bloody nasal discharge', 'Crusting', 'mucociliary clearance mechanism', 'bleeding', 'Nasal Obstruction Symptom Evaluation (NOSE) score', 'median NOSE score', 'rate of complications', 'NOSE score, STT and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225434', 'cui_str': 'Inferior nasal turbinate bone structure'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C0392222', 'cui_str': 'Potassium titanyl phosphate laser device'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C3494438', 'cui_str': 'Symptom Evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036023', 'cui_str': 'Saccharin'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0205204', 'cui_str': 'Crust'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",209.0,0.070627,Both the lasers impaired the mucociliary clearance mechanism of the nose till three months of post-operative follow up.,"[{'ForeName': 'Subhashini Puducherry', 'Initials': 'SP', 'LastName': 'Ravichandran', 'Affiliation': 'Department of Otorhinolarngology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'Karthikeyan', 'Initials': 'K', 'LastName': 'Ramasamy', 'Affiliation': 'Department of Otorhinolarngology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'Pradipta Kumar', 'Initials': 'PK', 'LastName': 'Parida', 'Affiliation': 'Department of Otorhinolarngology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Alexander', 'Affiliation': 'Department of Otorhinolarngology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'Sivaraman', 'Initials': 'S', 'LastName': 'Ganesan', 'Affiliation': 'Department of Otorhinolarngology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'Sunil Kumar', 'Initials': 'SK', 'LastName': 'Saxena', 'Affiliation': 'Department of Otorhinolarngology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}]",The Indian journal of medical research,['10.4103/ijmr.IJMR_424_18']
2442,32720907,Impact of an Electronic Health Service on Child Participation in Pediatric Oncology Care: Quasiexperimental Study.,"BACKGROUND
For children 6-12 years old, there is a shortage of electronic Health (eHealth) services that promote their participation in health care. Therefore, a digital communication tool, called Sisom, was developed to give children a voice in their health care. Children with long-term diseases want to be more involved in their health care and have the right to receive information, be listened to, express their opinions, and participate in decision making in health care. However, the outcomes of using Sisom in practice at pediatric oncology clinics have not been investigated.
OBJECTIVE
The aim of this study was to investigate children's participation during appointments with pediatricians at pediatric oncology clinics, with or without the use of the eHealth service Sisom.
METHODS
A quasiexperimental design with mixed methods was used. We analyzed 27 filmed appointments with pediatricians for 14 children (8 girls and 6 boys) aged 6-12 years (mean 8.3 years) with a cancer diagnosis. The intervention group consisted of children who used Sisom prior to their appointments with pediatricians at a pediatric oncology clinic, and the control group consisted of children who had appointments with pediatricians at 4 pediatric oncology clinics. Data from observations from the videos were quantitatively and qualitatively analyzed. The quantitative analysis included manual calculations of how many times the pediatricians spoke directly to the children, the proportion of the appointment time that the children were talking, and levels of participation by the children. For the qualitative analysis, we used directed content analysis to analyze the children's levels of participation guided by a framework based on Shier's model of participation.
RESULTS
Pediatricians directed a greater proportion of their discussion toward the child in the intervention group (731 occasions) than in the control group (624 occasions), but the proportion of the appointment time the children talked was almost the same for both the intervention and control groups (mean 17.0 minutes vs 17.6 minutes). The levels of participation corresponded to the first three levels of Shier's participation model: children were listened to, children were supported to express their views, and children's views were taken into account. The results showed an increased level of participation by the children in the intervention group. Several codes that were found did not fit into any of the existing categories, and a new category was thus formed: children received information.
CONCLUSIONS
This study shows that the eHealth service Sisom can increase children's participation during appointments with health care professionals. Further studies employing a randomized control design focusing on the effects of eHealth services on children's health outcomes, perceived participation, and cost-effectiveness could make a significant contribution to guiding the implementation of eHealth services in pediatric care.",2020,This study shows that the eHealth service Sisom can increase children's participation during appointments with health care professionals.,"['Children with long-term diseases', ""children's participation during appointments with pediatricians at pediatric oncology clinics, with or without the use of the eHealth service Sisom"", 'Child Participation in Pediatric Oncology Care', 'children 6-12 years old', '27 filmed appointments with pediatricians for 14 children (8 girls and 6 boys) aged 6-12 years (mean 8.3 years) with a cancer diagnosis']","['children who used Sisom prior to their appointments with pediatricians at a pediatric oncology clinic, and the control group consisted of children who had appointments with pediatricians at 4 pediatric oncology clinics', 'Electronic Health Service']","['level of participation', 'proportion of the appointment time the children talked']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0237433', 'cui_str': 'Pediatrician'}, {'cui': 'C3816504', 'cui_str': 'Pediatric oncology clinic'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3816504', 'cui_str': 'Pediatric oncology clinic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]",,0.0229075,This study shows that the eHealth service Sisom can increase children's participation during appointments with health care professionals.,"[{'ForeName': 'Britt-Mari', 'Initials': 'BM', 'LastName': 'Gilljam', 'Affiliation': 'School of Health and Welfare, Halmstad University, Halmstad, Sweden.'}, {'ForeName': 'Jens M', 'Initials': 'JM', 'LastName': 'Nygren', 'Affiliation': 'School of Health and Welfare, Halmstad University, Halmstad, Sweden.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Svedberg', 'Affiliation': 'School of Health and Welfare, Halmstad University, Halmstad, Sweden.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Arvidsson', 'Affiliation': 'School of Health and Welfare, Halmstad University, Halmstad, Sweden.'}]",Journal of medical Internet research,['10.2196/17673']
2443,32720908,Changing the Health Behavior of Patients With Cardiovascular Disease Through an Electronic Health Intervention in Three Different Countries: Cost-Effectiveness Study in the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) 2 Randomized Controlled Trial.,"BACKGROUND
During the last few decades, preventing the development of cardiovascular disease has become a mainstay for reducing cardiovascular morbidity and mortality. It has been suggested that interventions should focus more on committed approaches of self-care, such as electronic health techniques.
OBJECTIVE
This study aimed to provide evidence to understand the financial consequences of implementing the ""Do Cardiac Health: Advanced New Generation Ecosystem"" (Do CHANGE 2) intervention, which was evaluated in a multisite randomized controlled trial to change the health behavior of patients with cardiovascular disease.
METHODS
The cost-effectiveness analysis of the Do CHANGE 2 intervention was performed with the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing tool, based on a Markov model of five health states. The following two types of costs were considered for both study groups: (1) health care costs (ie, costs associated with the time spent by health care professionals on service provision, including consultations, and associated unplanned hospitalizations, etc) and (2) societal costs (ie, costs attributed to the time spent by patients and informal caregivers on care activities).
RESULTS
The Do CHANGE 2 intervention was less costly in Spain (incremental cost was -€2514.90) and more costly in the Netherlands and Taiwan (incremental costs were €1373.59 and €1062.54, respectively). Compared with treatment as usual, the effectiveness of the Do CHANGE 2 program in terms of an increase in quality-adjusted life-year gains was slightly higher in the Netherlands and lower in Spain and Taiwan.
CONCLUSIONS
In general, we found that the incremental cost-effectiveness ratio strongly varied depending on the country where the intervention was applied. The Do CHANGE 2 intervention showed a positive cost-effectiveness ratio only when implemented in Spain, indicating that it saved financial costs in relation to the effect of the intervention.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03178305; https://clinicaltrials.gov/ct2/show/NCT03178305.",2020,"The Do CHANGE 2 intervention was less costly in Spain (incremental cost was -€2514.90) and more costly in the Netherlands and Taiwan (incremental costs were €1373.59 and €1062.54, respectively).",['patients with cardiovascular disease'],['Electronic Health Intervention'],"['cardiovascular morbidity and mortality', 'incremental cost-effectiveness ratio', 'health care costs (ie, costs associated with the time spent by health care professionals on service provision, including consultations, and associated unplanned hospitalizations, etc) and (2) societal costs (ie, costs attributed to the time spent by patients and informal caregivers on care activities', 'quality-adjusted life-year gains', 'positive cost-effectiveness ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0814669,"The Do CHANGE 2 intervention was less costly in Spain (incremental cost was -€2514.90) and more costly in the Netherlands and Taiwan (incremental costs were €1373.59 and €1062.54, respectively).","[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Piera-Jiménez', 'Affiliation': 'Open Evidence Research Group, Universitat Oberta de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Winters', 'Affiliation': 'Smart Homes, Eindhoven, Netherlands.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Broers', 'Affiliation': 'Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Damià', 'Initials': 'D', 'LastName': 'Valero-Bover', 'Affiliation': 'Department of R&D, Badalona Serveis Assistencials, Badalona, Spain.'}, {'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Habibovic', 'Affiliation': 'Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Jos W M G', 'Initials': 'JWMG', 'LastName': 'Widdershoven', 'Affiliation': 'Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Folkvord', 'Affiliation': 'Open Evidence Research Group, Universitat Oberta de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Lupiáñez-Villanueva', 'Affiliation': 'Open Evidence Research Group, Universitat Oberta de Catalunya, Barcelona, Spain.'}]",Journal of medical Internet research,['10.2196/17351']
2444,32725609,A significant increase in exercise test performance with virtual group motivation: a randomised open-label controlled trial.,"AIMS
Exercise stress testing is frequently used for the assessment of coronary artery disease. As the validity of the test result is highly dependent on the patient’s cooperation and motivation, we hypothesised that virtual group motivation would result in a higher exercise capacity and may increase the test’s validity.
METHODS
108 patients at a Swiss teaching hospital with an indication for exercise testing were included in a controlled, open-label trial and randomised 1:1 to treadmill exercise testing whilst either watching a video of a walking group (video group, n = 43), or watching a static image of flowers (image group, n = 43). The video showed a group of five amateur runners, giving the patients the impression of running within the group. As primary outcomes, the performance achieved and the perceived level of comfort during the test were analysed.
RESULTS
The video group achieved significantly higher percentages of their age-predicted METs (149 ± 32% vs 135 ± 29%, p = 0.041) and longer exercise durations (11:12 ± 2:54 min vs 08:54 ± 02:39 min, p <0.001). Levels of comfort (8.4 ± 1.4 vs 7.5 ± 1.7 analogue scale, p = 0.011) and closeness to their physical limits (8.9 ± 0.8 vs 8.1 ± 1.5, p = 0.005) were rated significantly higher by patients in the video group.
CONCLUSIONS
Patients watching a video of a running group achieved significantly higher maximum exercise levels and longer test durations. This may have implications for the test’s validity. Furthermore, the virtual setting enhanced patient comfort. (This trial was formally registered at clinicaltrials.gov: trial ID NCT03704493.).",2020,"Levels of comfort (8.4 ± 1.4 vs 7.5 ± 1.7 analogue scale, p = 0.011) and closeness to their physical limits (8.9 ± 0.8 vs 8.1 ± 1.5, p = 0.005) were rated significantly higher by patients in the video group.
",['108 patients at a Swiss teaching hospital with an indication for exercise testing'],"['treadmill exercise testing whilst either watching a video of a walking group (video group, n = 43), or watching a static image of flowers (image group']","['performance achieved and the perceived level of comfort', 'closeness to their physical limits', 'exercise test performance', 'maximum exercise levels', 'Levels of comfort', 'longer exercise durations']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0330090', 'cui_str': 'Flowers'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.11557,"Levels of comfort (8.4 ± 1.4 vs 7.5 ± 1.7 analogue scale, p = 0.011) and closeness to their physical limits (8.9 ± 0.8 vs 8.1 ± 1.5, p = 0.005) were rated significantly higher by patients in the video group.
","[{'ForeName': 'Verena C', 'Initials': 'VC', 'LastName': 'Wilzeck', 'Affiliation': 'Department of Medicine, Cantonal Hospital of Baden, Switzerland.'}, {'ForeName': 'Janik', 'Initials': 'J', 'LastName': 'Hufschmid', 'Affiliation': 'Old Cantonal High School, Aarau, Switzerland.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bischof', 'Affiliation': 'Old Cantonal High School, Aarau, Switzerland.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hansi', 'Affiliation': 'Department of Medicine, Cantonal Hospital of Baden, Switzerland.'}, {'ForeName': 'Matthias P', 'Initials': 'MP', 'LastName': 'Nägele', 'Affiliation': 'Department of Medicine, Cantonal Hospital of Baden, Switzerland.'}, {'ForeName': 'Juerg H', 'Initials': 'JH', 'LastName': 'Beer', 'Affiliation': 'Department of Medicine, Cantonal Hospital of Baden, Switzerland / Centre of Molecular Cardiology, University of Zurich, Switzerland.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Hufschmid', 'Affiliation': 'Department of Medicine, Cantonal Hospital of Baden, Switzerland / 0041564862637 | 00414862636.'}]",Swiss medical weekly,['10.4414/smw.2020.20287']
2445,32725998,Impact of Angiotensin II Receptor Blockers on Clinical Outcomes after Percutaneous Coronary Intervention in Patients with Acute Myocardial Infarction Based on Data from the Korean National Health Insurance Database (2005-2014).,"BACKGROUND AND OBJECTIVES
The effectiveness of angiotensin II receptor blockers (ARBs) compared with angiotensin converting enzyme inhibitors (ACEIs) in patients with acute myocardial infarction (AMI) has not been established. We investigated the effects of ARBs on clinical outcomes after percutaneous coronary intervention (PCI) in AMI patients.
METHODS
Patients receiving ACEIs or ARBs after AMI treated with PCI between January 2005 and December 2014 were selected from the Korean National Health Insurance Service database. The primary endpoint was major cardiovascular adverse event (MACE; all-cause death, myocardial infarct [MI], or stroke).
RESULTS
We included patients regularly taking ACEIs (n=22,331) or ARBs (n=28,533) (medication possession ratio ≥80%). Compared with the ACEI group, the ARB group contained more females (31% vs. 18%), were older (mean, 63 vs. 60 years), and had more comorbidities, including hypertension (62.8% vs. 44.8%), diabetes (33.9% vs. 26.4%), congestive heart failure (7.9% vs. 4.3%), chronic obstructive pulmonary disease (25.5% vs. 18.9%), and end-stage renal disease (1.3% vs. 0.4%) (p<0.001 for all). After propensity score-matching, ARBs were associated with a 23% lower risk of MACE (hazard ratio [HR], 0.774; 95% confidence interval [CI], 0.715-0.838; p<0.001) than ACEIs. ARB use was also associated with a significantly reduced risk of death (HR, 0.741; 95% CI, 0.659-0.834; p<0.001), MI (HR, 0.731; 95% CI, 0.638-0.837; p<0.001), and revascularization (HR, 0.816; 95% CI, 0.773-0.861; p<0.001).
CONCLUSIONS
ARB use was associated with a lower risk of MACE, MI, and revascularization than ACEIs in our retrospective analysis of AMI patients who underwent PCI.",2020,"ARB use was also associated with a significantly reduced risk of death (HR, 0.741; 95% CI, 0.659-0.834; p<0.001), MI (HR, 0.731; 95% CI, 0.638-0.837; p<0.001), and revascularization (HR, 0.816; 95% CI, 0.773-0.861; p<0.001).
","['Patients receiving ACEIs or ARBs after AMI treated with PCI between January 2005 and December 2014 were selected from the Korean National Health Insurance Service database', 'patients regularly taking ACEIs (n=22,331) or ARBs (n=28,533) (medication possession ratio ≥80', 'AMI patients', 'patients with acute myocardial infarction (AMI', 'Patients with Acute Myocardial Infarction Based on Data from the Korean National Health Insurance Database (2005-2014']","['percutaneous coronary intervention (PCI', 'Percutaneous Coronary Intervention', 'ACEI', 'ARB', 'Angiotensin II Receptor Blockers', 'ARBs', 'angiotensin converting enzyme inhibitors (ACEIs', 'angiotensin II receptor blockers (ARBs']","['chronic obstructive pulmonary disease', 'diabetes', 'risk of death', 'major cardiovascular adverse event (MACE; all-cause death, myocardial infarct [MI], or stroke', 'congestive heart failure', 'stage renal disease', 'hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",,0.17824,"ARB use was also associated with a significantly reduced risk of death (HR, 0.741; 95% CI, 0.659-0.834; p<0.001), MI (HR, 0.731; 95% CI, 0.638-0.837; p<0.001), and revascularization (HR, 0.816; 95% CI, 0.773-0.861; p<0.001).
","[{'ForeName': 'Gwang Sil', 'Initials': 'GS', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Sanggye-Paik Hospital, Inje University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young Guk', 'Initials': 'YG', 'LastName': 'Ko', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea. ygko@yuhs.ac.'}, {'ForeName': 'Yongsung', 'Initials': 'Y', 'LastName': 'Suh', 'Affiliation': 'Department of Cardiology, Myeongji Hospital, Goyang, Korea.'}, {'ForeName': 'Hoyoun', 'Initials': 'H', 'LastName': 'Won', 'Affiliation': 'Cardiovascular & Arrhythmia Center, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Chul Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Jung Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Byeong Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Myeong Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}]",Korean circulation journal,['10.4070/kcj.2020.0057']
2446,32721923,Correction: Effectiveness of a Web-Based Tailored Intervention With Virtual Assistants Promoting the Acceptability of HPV Vaccination Among Mothers of Invited Girls: Randomized Controlled Trial.,[This corrects the article DOI: .].,2020,[This corrects the article DOI: .].,['Mothers of Invited Girls'],[],"['Vaccination', 'Acceptability of HPV']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}]",,0.124551,[This corrects the article DOI: .].,"[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Pot', 'Affiliation': 'Netherlands Organization for Applied Scientific Research (TNO), Child Health, Leiden, Netherlands.'}, {'ForeName': 'Theo Gwm', 'Initials': 'TG', 'LastName': 'Paulussen', 'Affiliation': 'Netherlands Organization for Applied Scientific Research (TNO), Child Health, Leiden, Netherlands.'}, {'ForeName': 'Robert Ac', 'Initials': 'RA', 'LastName': 'Ruiter', 'Affiliation': 'Department of Work and Social Psychology, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Eekhout', 'Affiliation': 'Netherlands Organization for Applied Scientific Research (TNO), Child Health, Leiden, Netherlands.'}, {'ForeName': 'Hester E', 'Initials': 'HE', 'LastName': 'de Melker', 'Affiliation': 'National Institute for Public Health and the Environment (RIVM), Centre for Infectious Disease Control, Bilthoven, Netherlands.'}, {'ForeName': 'Maxine Ea', 'Initials': 'ME', 'LastName': 'Spoelstra', 'Affiliation': 'Department of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Hilde M', 'Initials': 'HM', 'LastName': 'van Keulen', 'Affiliation': 'Netherlands Organization for Applied Scientific Research (TNO), Child Health, Leiden, Netherlands.'}]",Journal of medical Internet research,['10.2196/22565']
2447,32723088,Comparison of the effects of the Feldenkrais method versus core stability exercise in the management of chronic low back pain: a randomised control trial.,"OBJECTIVE
To investigate the effect of the Feldenkrais method versus core stability exercises on pain, disability, quality of life and interoceptive awareness in patients with chronic non-specific low back pain.
DESIGN
A single-blinded, randomised, controlled trial.
SETTING
Outpatient, sports medicine clinic of Mazandaran medical university.
PARTICIPANTS
Sixty patients with chronic non-specific low back pain randomised equally into the Feldenkrais method versus core stability exercises groups.
INTERVENTION
Intervention group received Feldenkrais method consisting of training theoretical content and supervised exercise therapy two sessions per week for five weeks. Control group received educational programme and home-based core stability exercises for five weeks.
OUTCOME MEASURES
All patients were examined by World Health Organization's Quality of life Questionnaire, McGill Pain Questionnaire, Oswestry Disability Questionnaire and Multidimensional Assessment of Interoceptive Awareness Questionnaire. All outcomes were measured at baseline and the end of the intervention.
RESULTS
There were statistically significant differences between groups for quality of life ( P = 0.006, from 45.51 to 60.49), interoceptive awareness ( P > 0.001, from 2.74 to 4.06) and disability ( P = 0.021, from 27.17 to 14.5) in favour of the Feldenkrais method. McGill pain score significantly decreased in both the Feldenkrais (from 15.33 to 3.63) and control groups (from 13.17 to 4.17), but there were no between-groups differences ( P = 0.16).
CONCLUSION
Feldenkrais method intervention gave increased benefits in improving quality of life, improving interoceptive awareness and reducing disability index.",2020,"There were statistically significant differences between groups for quality of life ( P = 0.006, from 45.51 to 60.49), interoceptive awareness ( P > 0.001, from 2.74 to 4.06) and disability ( P = 0.021, from 27.17 to 14.5) in favour of the Feldenkrais method.","['chronic low back pain', 'Sixty patients with chronic non-specific low back pain randomised equally into the', 'patients with chronic non-specific low back pain', 'Outpatient, sports medicine clinic of Mazandaran medical university']","['Feldenkrais method versus core stability exercise', 'Feldenkrais method versus core stability exercises', 'educational programme and home-based core stability exercises for five weeks', 'Feldenkrais method versus core stability exercises groups', 'Intervention group received Feldenkrais method consisting of training theoretical content and supervised exercise therapy']","['quality of life', 'disability', 'McGill pain score', ""World Health Organization's Quality of life Questionnaire, McGill Pain Questionnaire, Oswestry Disability Questionnaire and Multidimensional Assessment of Interoceptive Awareness Questionnaire"", 'quality of life, improving interoceptive awareness and reducing disability index', 'interoceptive awareness', 'pain, disability, quality of life and interoceptive awareness']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.0914339,"There were statistically significant differences between groups for quality of life ( P = 0.006, from 45.51 to 60.49), interoceptive awareness ( P > 0.001, from 2.74 to 4.06) and disability ( P = 0.021, from 27.17 to 14.5) in favour of the Feldenkrais method.","[{'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Sports and Exercise Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Adib', 'Affiliation': 'Department of Sports and Exercise Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Selk-Ghaffari', 'Affiliation': 'Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Misagh', 'Initials': 'M', 'LastName': 'Shafizad', 'Affiliation': 'Orthopedic Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Moradi', 'Affiliation': 'Education Development Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Madani', 'Affiliation': 'Department of Sports and Exercise Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Partovi', 'Affiliation': 'Department of Sports and Exercise Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Aliakbar', 'Initials': 'A', 'LastName': 'Mahmoodi', 'Affiliation': 'Department of Sports and Exercise Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}]",Clinical rehabilitation,['10.1177/0269215520947069']
2448,32717289,Obeticholic acid improves hepatic bile acid excretion in patients with primary biliary cholangitis.,"BACKGROUND & AIMS
Obeticholic acid (OCA) is an agonist of the nuclear bile acid receptor farnesoid X receptor, which regulates hepatic bile acid metabolism. We tested whether OCA treatment would influence hepatic transport of conjugated bile acids in patients with primary biliary cholangitis (PBC) who responded inadequately to treatment with ursodeoxycholic acid (UDCA).
PATIENTS & METHODS
Eight UDCA-treated patients with PBC with alkaline phosphatase ≥1.5 times the upper limit of normal range participated in a double-blind, placebo-controlled study. While continuing on UDCA, the patients were randomised to two 3-month crossover treatment periods with placebo and OCA, in random order, separated by a 1-month washout period without study treatment. After each of the two treatment periods, we determined rate constants for transport of conjugated bile acids between blood, hepatocytes, biliary canaliculi, and bile ducts by positron emission tomography of the liver using the conjugated bile acid tracer [N-methyl- 11 C]cholylsarcosine ( 11 C-CSar). The hepatic blood perfusion was measured using infusion of indocyanine green and Fick's principle.
RESULTS
Compared with placebo, OCA increased hepatic blood perfusion by a median of 11% (p = 0.045), the unidirectional uptake clearance of 11 C-CSar from blood into hepatocytes by a median of 11% (p = 0.01), and the rate constant for secretion of 11 C-CSar from hepatocytes into biliary canaliculi by a median of 73% (p = 0.03). This resulted in an OCA-induced decrease in the hepatocyte residence time of 11 C-CSar by a median of 30% (p = 0.01), from group median 11 min to 8 min.
CONCLUSIONS
This study of UDCA-treated patients with PBC showed that, compared with placebo, OCA increased the hepatic transport of the conjugated bile acid tracer 11 C-CSar, and thus endogenous conjugated bile acids, from hepatocytes into biliary canaliculi. As a result, OCA reduced the time hepatocytes are exposed to potentially cytotoxic bile acids.
LAY SUMMARY
Primary biliary cholangitis is a chronic liver disease in which the small bile ducts are progressively destroyed. We tested whether the treatment with obeticholic acid (OCA) would improve liver excretion of bile acids compared with placebo in 8 patients with primary biliary cholangitis. A special scanning technique (PET scan) showed that OCA increased the transport of bile acids from blood to bile. OCA thereby reduced the time that potentially toxic bile acids reside in the liver by approximately one-third.",2020,"Compared to placebo, OCA increased the hepatic blood perfusion by median 11% (p = 0.045), the unidirectional uptake clearance of 11 C-CSar from blood into hepatocytes by median 11% (p = 0.01), and the rate constant for secretion of 11 C-CSar from hepatocytes into biliary canaliculi by median 73% (p = 0.03).","['patients with primary biliary cholangitis (PBC) who responded inadequately to treatment with', 'patients with primary biliary cholangitis', 'Eight UDCA-treated PBC patients with alkaline phosphatase ≥ 1.5 ULN participated in a double-blind']","['ursodeoxycholic acid (UDCA', 'Obeticholic acid', 'OCA', 'placebo and OCA', 'placebo, OCA', 'Obeticholic acid (OCA', 'UDCA-treated PBC', 'placebo']","['rate constant for secretion', 'unidirectional uptake clearance', 'hepatocyte residence time', 'hepatic bile acid excretion', 'hepatic blood perfusion', 'rate constants for transport of conjugated bile acids between blood, hepatocytes, biliary canaliculi and bile ducts by positron emission tomography (PET) of the liver using the conjugated bile acid tracer [N-methyl']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0227525', 'cui_str': 'Hepatic parenchymal cell'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0443599', 'cui_str': 'Conjugated bile acids'}, {'cui': 'C0005400', 'cui_str': 'Bile duct structure'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}]",,0.0897823,"Compared to placebo, OCA increased the hepatic blood perfusion by median 11% (p = 0.045), the unidirectional uptake clearance of 11 C-CSar from blood into hepatocytes by median 11% (p = 0.01), and the rate constant for secretion of 11 C-CSar from hepatocytes into biliary canaliculi by median 73% (p = 0.03).","[{'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Kjærgaard', 'Affiliation': 'Department of Hepatology & Gastroenterology, Aarhus University Hospital, Aarhus, Denmark; Department of Nuclear Medicine & PET Centre, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Frisch', 'Affiliation': 'Department of Nuclear Medicine & PET Centre, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sørensen', 'Affiliation': 'Department of Hepatology & Gastroenterology, Aarhus University Hospital, Aarhus, Denmark; Department of Nuclear Medicine & PET Centre, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ole Lajord', 'Initials': 'OL', 'LastName': 'Munk', 'Affiliation': 'Department of Nuclear Medicine & PET Centre, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Alan Frederick', 'Initials': 'AF', 'LastName': 'Hofmann', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of California at San Diego, San Diego, CA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Horsager', 'Affiliation': 'Department of Nuclear Medicine & PET Centre, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anna Christina', 'Initials': 'AC', 'LastName': 'Schacht', 'Affiliation': 'Department of Nuclear Medicine & PET Centre, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Erickson', 'Affiliation': 'Intercept Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shapiro', 'Affiliation': 'Intercept Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Keiding', 'Affiliation': 'Department of Hepatology & Gastroenterology, Aarhus University Hospital, Aarhus, Denmark; Department of Nuclear Medicine & PET Centre, Aarhus University Hospital, Aarhus, Denmark. Electronic address: susakeid@clin.au.dk.'}]",Journal of hepatology,['10.1016/j.jhep.2020.07.028']
2449,32725346,"A prospective, single-arm, multicenter trial of neoadjuvant chemotherapy with mFOLFOX6 plus panitumumab without radiotherapy for locally advanced rectal cancer.","PURPOSE
The present study evaluated the safety and efficacy of neoadjuvant chemotherapy with modified 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus panitumumab in clinical stage III rectal cancer with KRAS wild-type.
METHODS
We conducted a prospective multicenter phase II trial. KRAS wild-type clinical stage III rectal cancer patients were enrolled. Patients received 6 cycles of mFOLFOX6 with 6 mg/kg panitumumab as neoadjuvant chemotherapy. The primary outcome was the response rate (RR) defined by RECIST. Lateral lymph node dissection (LLDN) was performed when patients had a locally advanced tumor < 9 cm from the anal margin.
RESULTS
A total of 50 patients were enrolled. Twelve (24.0%) experienced grade 3-4 adverse events during neoadjuvant chemotherapy. The RR was 88.0% (complete response 2.0%, partial response 86.0%), which met the primary outcome. All patients underwent laparoscopic surgery and achieved R0 resection. Seven patients underwent resection of other adjacent organs, and 43 underwent LLND. Twelve patients (24.0%) experienced grade 3-4 postoperative complications, and 4 (8.0%) had pathological complete response (pCR). Thirteen patients (26.0%) had lymph node metastasis. Forty-five patients (90.0%) received postoperative adjuvant chemotherapy. The 3-year relapse-free survival (RFS) and overall survival (OS) rates were 79.0% and 93.7%, respectively.
CONCLUSIONS
Neoadjuvant chemotherapy of mFOLFOX6 plus panitumumab without radiotherapy resulted in a low pCR rate but a high PR rate, low local recurrence rate, and good long-term outcome, suggesting that this treatment strategy may be a viable option for patients unable or unwilling to receive radiotherapy. The trial was registered with the UMIN Clinical Trials Registry, number 000006039.",2020,"The 3-year relapse-free survival (RFS) and overall survival (OS) rates were 79.0% and 93.7%, respectively.
","['KRAS wild-type clinical stage III rectal cancer patients were enrolled', 'Thirteen patients (26.0%) had lymph node metastasis', 'locally advanced rectal cancer', 'Seven patients underwent resection of other adjacent organs, and 43 underwent LLND', 'clinical stage III rectal cancer with KRAS wild-type', '50 patients were enrolled']","['neoadjuvant chemotherapy with modified 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus panitumumab', 'mFOLFOX6 with 6\xa0mg/kg panitumumab as neoadjuvant chemotherapy', 'radiotherapy', 'postoperative adjuvant chemotherapy', 'laparoscopic surgery and achieved R0 resection', 'neoadjuvant chemotherapy with mFOLFOX6 plus panitumumab without radiotherapy']","['response rate (RR) defined by RECIST', 'grade 3-4 postoperative complications', 'pathological complete response (pCR', 'safety and efficacy', 'Lateral lymph node dissection (LLDN', 'low pCR rate', 'RR', '3-year relapse-free survival (RFS) and overall survival (OS) rates']","[{'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205578', 'cui_str': 'Clinical stage III'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",50.0,0.496551,"The 3-year relapse-free survival (RFS) and overall survival (OS) rates were 79.0% and 93.7%, respectively.
","[{'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Toritani', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan. nabe-jun@comet.ocn.ne.jp.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Suwa', 'Affiliation': 'Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, 4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Suwa', 'Affiliation': 'Department of Surgery, Yokosuka Kyosai Hospital, Yokosuka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ishibe', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Ota', 'Affiliation': 'Department of Surgery, Yokohama Minato Red Cross hospital, Yokohama, Japan.'}, {'ForeName': 'Chikara', 'Initials': 'C', 'LastName': 'Kunisaki', 'Affiliation': 'Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, 4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Endo', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}]",International journal of colorectal disease,['10.1007/s00384-020-03693-w']
2450,32729342,Dehydrated human amnion and chorion allograft versus standard of care alone in treatment of Wagner 1 diabetic foot ulcers: a trial-based health economics study.,"AIMS
The aim of this health economics study was to estimate the cost-utility of an aseptically processed, dehydrated human amnion and chorion allograft (dHACA) plus standard of care (SOC) (group 1) versus SOC alone (group 2) based on a published randomized controlled trial in which patients who had an eligible Wagner 1 diabetic foot ulcer wound were randomized to either of these treatments.
MATERIALS AND METHODS
A Markov microsimulation was used to project trial results out to a 1-year horizon time with a third-party payer perspective. The starting health state was an unhealed non-infected ulcer with other health states of healed ulcer, infected non-healed ulcer, cellulitis, osteomyelitis, and absorbing states of dead or amputation. All patients started with unhealed non-infected ulcers at cycle 0. Costs were incurred by patients for procedures at hospital outpatient wound care provider-based departments (PBDs) and hospitals (if complications occurred) and were calculated using time-based activity costing methods. Effectiveness units were quality-adjusted life years (QALYs) computed from literature utility values. One-way and probabilistic sensitivity analysis (PSA) were also conducted.
RESULTS
After 1 year, the calculated incremental cost-effectiveness ratio (ICER) for group 1 versus group 2 was -$4,373 with group 1 (dHACA) being dominant over group 2 (SOC). PSA demonstrated that group 1 had 69.2% lower cost values with increased positive incremental effectiveness for 94.9% of values. A willingness to pay (WTP) curve showed that about 92% of interventions were cost effective for group 1 when $50,000 was paid.
CONCLUSIONS
The results of this study demonstrated that dHACA added to SOC compared to SOC alone was extremely cost-effective in the defined trial population.",2020,PSA demonstrated that group 1 had 69.2% lower cost values with increased positive incremental effectiveness for 94.9% of values.,"['Wagner 1 diabetic foot ulcers', 'patients who had an eligible Wagner 1 diabetic foot ulcer wound']","['Dehydrated human amnion and chorion allograft versus standard of care alone', 'aseptically processed, dehydrated human amnion and chorion allograft (dHACA) plus standard of care (SOC', 'SOC', 'dHACA', 'SOC alone']","['calculated incremental cost-effectiveness ratio (ICER', 'cost effective']","[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]","[{'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0008503', 'cui_str': 'Chorionic structure'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0820619,PSA demonstrated that group 1 had 69.2% lower cost values with increased positive incremental effectiveness for 94.9% of values.,"[{'ForeName': 'Marissa J', 'Initials': 'MJ', 'LastName': 'Carter', 'Affiliation': 'Strategic Solutions, Inc, Bozeman, MT, USA.'}]",Journal of medical economics,['10.1080/13696998.2020.1803888']
2451,32727707,Randomized Study of Maintenance Pemetrexed Versus Observation for Treatment of Malignant Pleural Mesothelioma: CALGB 30901.,"BACKGROUND
The role of maintenance therapy for malignant pleural mesothelioma (MPM) is unknown. We performed a randomized phase II trial to determine if continuation of pemetrexed after first-line pemetrexed and platinum would improve progression-free survival (PFS).
PATIENTS AND METHODS
Eligible patients with unresectable MPM, without disease progression following 4 to 6 cycles of pemetrexed and platinum were randomized 1:1 to observation or continuation of pemetrexed until progression, stratified by number of cycles (< 6 or 6), cis- or carboplatin containing regimen, and histology. Study size was calculated based on the assumption that observation would produce a median PFS of 3 months and pemetrexed would yield median PFS of 6 months.
RESULTS
A total of 72 patients were registered from December 2010 to June 2016. The study closed early after 53 patients were randomized; 49 eligible (22 on the observation arm and 27 on the pemetrexed arm) were included in the analysis. The median PFS was 3 months (95% confidence interval [CI], 2.6-11.9 months) on observation and 3.4 months (95% CI, 2.8-9.8 months) on pemetrexed (hazard ratio [HR], 0.99; 95% CI, 0.51-1.90; P = .9733). The median overall survival (OS) was 11.8 months (95% CI, 9.3-28.7 months) for observation, and 16.3 months (95% CI, 10.5-26.0 months) for pemetrexed (HR, 0.86; 95% CI, 0.44-1.71; P = .6737). Grade 3 or 4 toxicities on the pemetrexed arm included anemia (8%), lymphopenia (8%), neutropenia (4%), and fatigue (4%). A higher baseline level of soluble mesothelin-related peptide was associated with worse PFS (HR, 1.86; 95% CI, 1.00-3.46; P = .049).
CONCLUSION
Maintenance pemetrexed following initial pemetrexed and platinum chemotherapy does not improve PFS in patients with MPM.",2020,"A higher baseline level of soluble mesothelin-related peptide was associated with worse PFS (HR, 1.86; 95% CI, 1.00-3.46; P = .049).
","['patients with MPM', 'malignant pleural mesothelioma (MPM', '53 patients were randomized; 49 eligible (22 on the observation arm and 27 on the pemetrexed arm) were included in the analysis', '72 patients were registered from December 2010 to June 2016', 'Eligible patients with unresectable MPM, without disease progression following 4 to 6 cycles of']","['cis- or carboplatin containing regimen, and histology', 'pemetrexed and platinum chemotherapy', 'pemetrexed and platinum', 'pemetrexed after first-line pemetrexed and platinum', 'Maintenance Pemetrexed']","['PFS', 'neutropenia', 'median overall survival (OS', 'anemia', 'Grade 3 or 4 toxicities', 'lymphopenia', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0007099', 'cui_str': 'Carcinoma in situ'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}]",72.0,0.170713,"A higher baseline level of soluble mesothelin-related peptide was associated with worse PFS (HR, 1.86; 95% CI, 1.00-3.46; P = .049).
","[{'ForeName': 'Arkadiusz Z', 'Initials': 'AZ', 'LastName': 'Dudek', 'Affiliation': 'Regions Cancer Care Center, HealthPartners Inc, Minneapolis, MN. Electronic address: arkadiusz.z.dudek@healthpartners.com.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Gu', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Duong', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Stinchcombe', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kratzke', 'Affiliation': 'Division of Hematology, Oncology and Transplantation, University of Minnesota/Masonic Cancer Center, Minneapolis, MN.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Borghaei', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Everett E', 'Initials': 'EE', 'LastName': 'Vokes', 'Affiliation': 'Department of Medicine, University of Chicago Comprehensive Cancer Center, Chicago, IL.'}, {'ForeName': 'Hedy L', 'Initials': 'HL', 'LastName': 'Kindler', 'Affiliation': 'Department of Medicine, University of Chicago Comprehensive Cancer Center, Chicago, IL.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.06.025']
2452,32725073,Restrictive versus Liberal Fluid Therapy for Post-Cesarean Acute Kidney Injury in Severe Preeclampsia: a Pilot Randomized Clinical Trial.,"OBJECTIVES
The aim of this study was to determine whether a restrictive compared to a liberal fluid therapy will increase postoperative acute kidney injury (AKI) in patients with severe preeclampsia.
METHODS
A total of 46 patients (mean age, 32 years; standard deviation, 6.8 years) with severe preeclampsia were randomized to liberal (1500 ml of lactated Ringer's, n=23) or restrictive (250 ml of lactated Ringer's, n=23) intravenous fluid regimen during cesarean section. The primary outcome was the development of a postoperative renal dysfunction defined by AKI Network stage ≥1. Serum cystatin C and neutrophil gelatinase-associated lipocalin (NGAL) were evaluated at postoperative days 1 and 2. ClinicalTrials.gov: NCT02214186.
RESULTS
The rate of postoperative AKI was 43.5% in the liberal fluid group and 43.5% in the restrictive fluid group (p=1.0). Intraoperative urine output was higher in the liberal (116 ml/h, IQR 69-191) than in the restrictive fluid group (80 ml/h, IQR 37-110, p<0.05). In both groups, serum cystatin C did not change from postoperative day 1 compared to the preoperative period and significantly decreased on postoperative day 2 compared to postoperative day 1 (p<0.05). In the restrictive fluid group, NGAL levels increased on postoperative day 1 compared to the preoperative period (p<0.05) and decreased on postoperative day 2 compared to postoperative day 1 (p<0.05).
CONCLUSION
Among patients with severe preeclampsia, a restrictive fluid regimen during cesarean section was not associated with increased postoperative AKI.",2020,"Intraoperative urine output was higher in the liberal (116 ml/h, IQR 69-191) than in the restrictive fluid group (80 ml/h, IQR 37-110, p<0.05).","['patients with severe preeclampsia', 'Post-Cesarean Acute Kidney Injury in Severe Preeclampsia', '46 patients (mean age, 32 years; standard deviation, 6.8 years) with severe preeclampsia']","[""liberal (1500 ml of lactated Ringer's, n=23) or restrictive (250 ml of lactated Ringer's, n=23) intravenous fluid regimen"", 'Restrictive versus Liberal Fluid Therapy', 'liberal fluid therapy']","['Serum cystatin C and neutrophil gelatinase-associated lipocalin (NGAL', 'Intraoperative urine output', 'NGAL levels', 'postoperative AKI', 'serum cystatin C', 'rate of postoperative AKI', 'development of a postoperative renal dysfunction defined by AKI Network stage ≥1', 'postoperative acute kidney injury (AKI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341950', 'cui_str': 'Severe pre-eclampsia'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]","[{'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",46.0,0.206813,"Intraoperative urine output was higher in the liberal (116 ml/h, IQR 69-191) than in the restrictive fluid group (80 ml/h, IQR 37-110, p<0.05).","[{'ForeName': 'Wallace Andrino da', 'Initials': 'WAD', 'LastName': 'Silva', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Carlo Victor A', 'Initials': 'CVA', 'LastName': 'Varela', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Aline Macedo', 'Initials': 'AM', 'LastName': 'Pinheiro', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Paula Castro', 'Initials': 'PC', 'LastName': 'Scherer', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Rossana P V', 'Initials': 'RPV', 'LastName': 'Francisco', 'Affiliation': 'Departamento de Obstetricia e Ginecologia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Marcelo Luis Abramides', 'Initials': 'MLA', 'LastName': 'Torres', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Maria José C', 'Initials': 'MJC', 'LastName': 'Carmona', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bliacheriene', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Lúcia C', 'Initials': 'LC', 'LastName': 'Andrade', 'Affiliation': 'Departamento de Nefrologia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': 'Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate (DISC), Universitè degli Studi di Genova, Genoa, Italy.'}, {'ForeName': 'Luiz Marcelo S', 'Initials': 'LMS', 'LastName': 'Malbouisson', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e1797']
2453,32729835,Effects of Incentives on Adherence to a Web-Based Intervention Promoting Physical Activity: Naturalistic Study.,"BACKGROUND
Despite many advantages of web-based health behavior interventions such as wide accessibility or low costs, these interventions are often accompanied by high attrition rates, particularly in usage under real-life conditions. It would therefore be helpful to implement strategies such as the use of financial incentives to motivate program participation and increase adherence.
OBJECTIVE
This naturalistic study examined real-life usage data of a 12-week web-based physical activity (PA) intervention (Fitness Coach) among insurants who participated in an additional incentive program (incentive group) and those who did not (nonincentive group). Users in the incentive group had the perspective of receiving €30 (about US $33) cash back at the end of the intervention.
METHODS
Registration and real-life usage data as part of routine data management and evaluation of the Fitness Coach were analyzed between September 2016 and June 2018. Depending on the duration of use and the weekly recording of tasks, 4 adherence groups (low, occasional, strong, and complete adherence) were defined. Demographic characteristics were collected by a self-reported questionnaire at registration. We analyzed baseline predictors and moderators of complete adherence such as participation in the program, age, gender, and BMI using binary logistic regressions.
RESULTS
A total of 18,613 eligible persons registered for the intervention. Of these, 15,482 users chose to participate in the incentive program (incentive group): mean age 42.4 (SD 14.4) years, mean BMI 24.5 (SD 4.0) kg/m 2 , median (IQR) BMI 23.8 (21.7-26.4) kg/m 2 ; 65.12% (10,082/15,482) female; and 3131 users decided not to use the incentive program (nonincentive group): mean age 40.7 (SD 13.4) years, mean BMI 26.2 (SD 5.0) kg/m 2 , median BMI 25.3 (IQR 22.6-28.7) kg/m 2 ; 72.18% (2260/3131) female. At the end of the intervention, participants in the incentive program group showed 4.8 times higher complete adherence rates than those in the nonincentive program group (39.2% vs 8.1%), also yielding significantly higher odds to complete the intervention (odds ratio [OR] 12.638) for the incentive program group. Gender significantly moderated the effect with men in the incentive group showing higher odds to be completely adherent than women overall and men in the nonincentive group (OR 1.761). Furthermore, older age and male gender were significant predictors of complete adherence for all participants, whereas BMI did not predict intervention completion.
CONCLUSIONS
This is the first naturalistic study in the field of web-based PA interventions that shows the potential of even small financial incentives to increase program adherence. Male users, in particular, seem to be strongly motivated by incentives to complete the intervention. Based on these findings, health care providers can use differentiated incentive systems to increase regular participation in web-based PA interventions.",2020,"At the end of the intervention, participants in the incentive program group showed 4.8 times higher complete adherence rates than those in the nonincentive program group (39.2% vs 8.1%), also yielding significantly higher odds to complete the intervention (odds ratio [OR] 12.638) for the incentive program group.","['Male users', '18,613 eligible persons registered for the intervention', 'age 42.4 (SD 14.4) years, mean BMI 24.5 (SD 4.0) kg/m 2 , median (IQR) BMI 23.8 (21.7-26.4) kg/m 2 ; 65.12% (10,082/15,482) female; and 3131 users decided not to use the incentive program (nonincentive group', '15,482 users chose to participate in the incentive program (incentive group): mean', 'insurants who participated in an additional incentive program (incentive group) and those who did not (nonincentive group', 'mean age 40.7 (SD 13.4) years, mean BMI 26.2']",['12-week web-based physical activity (PA) intervention (Fitness Coach'],['complete adherence rates'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C5191366', 'cui_str': '21.7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C4517558', 'cui_str': '13.4'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557773', 'cui_str': 'Coach'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",18613.0,0.0359261,"At the end of the intervention, participants in the incentive program group showed 4.8 times higher complete adherence rates than those in the nonincentive program group (39.2% vs 8.1%), also yielding significantly higher odds to complete the intervention (odds ratio [OR] 12.638) for the incentive program group.","[{'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Wurst', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Maliezefski', 'Affiliation': 'IGEL-M GbR, Bad Oldesloe, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ramsenthaler', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Brame', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Fuchs', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}]",Journal of medical Internet research,['10.2196/18338']
2454,32727577,Pharmacokinetic interactions of esaxerenone with amlodipine and digoxin in healthy Japanese subjects.,"BACKGROUND
To investigate the effects of coadministration of esaxerenone with amlodipine on the pharmacokinetics (PK) of each drug, and of esaxerenone on the PK of digoxin.
METHODS
In three open-label, single-sequence, crossover studies, healthy Japanese males received single oral doses of esaxerenone 2.5 mg (Days 1, 15), with amlodipine 10 mg/day (Days 8-18) (Study 1, N = 24); single doses of amlodipine 2.5 mg (Days 1, 21), with esaxerenone 5 mg/day (Days 8-25) (Study 2; N = 20); or digoxin 0.25 mg/day (Days 1-15) with esaxerenone 5 mg/day (Days 11-15) (Study 3; N = 20). PK parameters and safety were assessed.
RESULTS
Study 1: esaxerenone peak plasma concentration (C max ) and time to C max were unaltered by amlodipine coadministration, but mean half-life was slightly prolonged from 18.5 to 20.9 h. Geometric least-squares mean (GLSM) ratios for C max , area under the plasma concentration-time curve (AUC) from zero to last measurable concentration and from zero to infinity for esaxerenone + amlodipine versus esaxerenone were 0.958, 1.154, and 1.173, respectively. Study 2: corresponding GLSM ratios for amlodipine + esaxerenone versus amlodipine were 1.099, 1.185, and 1.214. Study 3: esaxerenone did not markedly alter digoxin PK. GLSM ratios for C max , trough plasma concentration, and AUC during a dosing interval for digoxin versus esaxerenone + digoxin were 1.130, 1.088, and 1.072, respectively.
CONCLUSIONS
No drug-drug interactions are expected during combination therapy with esaxerenone and either amlodipine or digoxin, based on a lack of any clinically relevant PK changes.
TRIAL REGISTRATION
Studies 1 and 2: JapicCTI-163379 (registered on 20 September 2016); Study 3: JapicCTI-163443 (registered on 24 November 2016).",2020,"No drug-drug interactions are expected during combination therapy with esaxerenone and either amlodipine or digoxin, based on a lack of any clinically relevant PK changes.
","['JapicCTI-163379 (registered on 20 September 2016); Study 3: JapicCTI-163443 (registered on 24 November 2016', 'healthy Japanese subjects', 'healthy Japanese males']","['esaxerenone with amlodipine and digoxin', 'esaxerenone + amlodipine', 'amlodipine or digoxin', 'digoxin versus esaxerenone + digoxin', 'esaxerenone with amlodipine', 'amlodipine', 'esaxerenone', 'esaxerenone 2.5\u2009mg', 'amlodipine + esaxerenone versus amlodipine', 'digoxin']","['esaxerenone peak plasma concentration (C max ) and time to C max', 'digoxin PK', 'GLSM ratios', 'PK parameters and safety', 'GLSM) ratios for C max , area under the plasma concentration-time curve (AUC', 'GLSM ratios for C max , trough plasma concentration, and AUC']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C5139864', 'cui_str': 'esaxerenone'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C5139864', 'cui_str': 'esaxerenone'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444506', 'cui_str': 'Trough'}]",,0.106603,"No drug-drug interactions are expected during combination therapy with esaxerenone and either amlodipine or digoxin, based on a lack of any clinically relevant PK changes.
","[{'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Kirigaya', 'Affiliation': 'Daiichi Sankyo Co., Ltd., 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan. kirigaya.yoshiaki.c8@daiichisankyo.co.jp.'}, {'ForeName': 'Masanari', 'Initials': 'M', 'LastName': 'Shiramoto', 'Affiliation': 'SOUSEIKAI Hakata Clinic, 6-18, Tenyamachi, Hakata-ku, Fukuoka, 812-0025, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Ishizuka', 'Affiliation': 'Daiichi Sankyo Co., Ltd., 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.'}, {'ForeName': 'Hinako', 'Initials': 'H', 'LastName': 'Uchimaru', 'Affiliation': 'SOUSEIKAI Hakata Clinic, 6-18, Tenyamachi, Hakata-ku, Fukuoka, 812-0025, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Irie', 'Affiliation': 'SOUSEIKAI Hakata Clinic, 6-18, Tenyamachi, Hakata-ku, Fukuoka, 812-0025, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Daiichi Sankyo Co., Ltd., 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Daiichi Sankyo Co., Ltd., 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Nakatsu', 'Affiliation': 'Daiichi Sankyo Co., Ltd., 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Nishikawa', 'Affiliation': 'Daiichi Sankyo Co., Ltd., 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ishizuka', 'Affiliation': 'Daiichi Sankyo Co., Ltd., 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.'}]",BMC pharmacology & toxicology,['10.1186/s40360-020-00423-4']
2455,32724912,Does concurrent use of clopidogrel and PPIs increase CV risk in patients with ACS?,"No. Adding a proton pump inhibitor (PPI) in patients taking antiplatelet medications such as clopidogrel for acute coronary syndrome (ACS) doesn't increase the composite risk of cardiovascular (CV) events: CV death, myocardial infarction (MI), and cerebrovascular accident (CVA) (strength of recommendation: B, randomized, controlled trial [RCT] and prepon-derance of posthoc analyses of large RCTs).",2020,"Adding a proton pump inhibitor (PPI) in patients taking antiplatelet medications such as clopidogrel for acute coronary syndrome (ACS) doesn't increase the composite risk of cardiovascular (CV) events: CV death, myocardial infarction (MI), and cerebrovascular accident (CVA) (strength of recommendation: B, randomized, controlled trial [RCT] and prepon-derance of posthoc analyses of large RCTs).","['patients taking antiplatelet medications such as clopidogrel for acute coronary syndrome (ACS', 'patients with ACS']","['proton pump inhibitor (PPI', 'clopidogrel and PPIs']","['CV risk', 'composite risk of cardiovascular (CV) events: CV death, myocardial infarction (MI), and cerebrovascular accident (CVA) (strength of recommendation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.0371785,"Adding a proton pump inhibitor (PPI) in patients taking antiplatelet medications such as clopidogrel for acute coronary syndrome (ACS) doesn't increase the composite risk of cardiovascular (CV) events: CV death, myocardial infarction (MI), and cerebrovascular accident (CVA) (strength of recommendation: B, randomized, controlled trial [RCT] and prepon-derance of posthoc analyses of large RCTs).","[{'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Shehata', 'Affiliation': 'Valley Medical Center, Renton, WA, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Valley Family Medicine Residency, University of Washington at Valley in Renton, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Kelsberg', 'Affiliation': 'Valley Family Medicine Residency, University of Washington at Valley in Renton, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Safranek', 'Affiliation': 'University of Washington Health Sciences Library, Seattle, USA.'}]",The Journal of family practice,[]
2456,32729838,Effects of the e-Motivate4Change Program on Metabolic Syndrome in Young Adults Using Health Apps and Wearable Devices: Quasi-Experimental Study.,"BACKGROUND
The health behaviors of young adults lag behind those of other age groups, and active health management is needed to improve health behaviors and prevent chronic diseases. In addition, developing good lifestyle habits earlier in life could reduce the risk of metabolic syndrome (MetS) later on.
OBJECTIVE
The aim of this study is to investigate the effects of the e-Motivate4Change program, for which health apps and wearable devices were selected based on user needs. The program was developed for the prevention and management of MetS in young adults.
METHODS
This experimental study used a nonequivalent control group. In total, 59 students from 2 universities in Daegu, Korea participated in the study (experimental group n=30; control group n=29). Data were collected over 4 months, from June 1 to September 30, 2018. The experimental group received a 12-week e-Motivate4Change program intervention, and the control group received MetS education and booklets without the e-Motivate4Change program intervention.
RESULTS
After the program, the experimental group had significantly higher scores for health-related lifestyle (t=3.86; P<.001) and self-efficacy (t=6.00; P<.001) than did the control group. Concerning BMI, there were significant effects by group (F=1.01; P<.001) and for the group × time interaction (F=4.71; P=.034). Concerning cholesterol, there were significant main effects for group (F=4.32; P=.042) and time (F=9.73; P<.001).
CONCLUSIONS
The e-Motivate4Change program effectively improved participants' health-related lifestyle scores and self-efficacy, and significantly reduced their BMI and cholesterol levels. The program can be used to identify and prevent MetS among young adults.",2020,"Concerning cholesterol, there were significant main effects for group (F=4.32; P=.042) and time (F=9.73; P<.001).
","['59 students from 2 universities in Daegu, Korea participated in the study (experimental group n=30; control group n=29', 'young adults', 'Young Adults Using Health Apps and Wearable Devices']","['e-Motivate4Change program', '12-week e-Motivate4Change program intervention, and the control group received MetS education and booklets without the e-Motivate4Change program intervention', 'e-Motivate4Change Program']","[""participants' health-related lifestyle scores and self-efficacy"", 'higher scores for health-related lifestyle', 'Metabolic Syndrome', 'self-efficacy', 'BMI and cholesterol levels']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",59.0,0.0179104,"Concerning cholesterol, there were significant main effects for group (F=4.32; P=.042) and time (F=9.73; P<.001).
","[{'ForeName': 'Ji-Soo', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Keimyung University, Daegu, Republic of Korea.'}, {'ForeName': 'Min-Ah', 'Initials': 'MA', 'LastName': 'Kang', 'Affiliation': 'Keimyung University, Daegu, Republic of Korea.'}, {'ForeName': 'Soo-Kyoung', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Keimyung University, Daegu, Republic of Korea.'}]",Journal of medical Internet research,['10.2196/17031']
2457,32729843,Technology-Enabled Self-Management of Chronic Obstructive Pulmonary Disease With or Without Asynchronous Remote Monitoring: Randomized Controlled Trial.,"BACKGROUND
Chronic obstructive pulmonary disease (COPD) is a leading cause of mortality and leads to frequent hospital admissions and emergency department (ED) visits. COPD exacerbations are an important patient outcome, and reducing their frequency would result in significant cost savings. Remote monitoring and self-monitoring could both help patients manage their symptoms and reduce the frequency of exacerbations, but they have different resource implications and have not been directly compared.
OBJECTIVE
This study aims to compare the effectiveness of implementing a technology-enabled self-monitoring program versus a technology-enabled remote monitoring program in patients with COPD compared with a standard care group.
METHODS
We conducted a 3-arm randomized controlled trial evaluating the effectiveness of a remote monitoring and a self-monitoring program relative to standard care. Patients with COPD were recruited from outpatient clinics and a pulmonary rehabilitation program. Patients in both interventions used a Bluetooth-enabled device kit to monitor oxygen saturation, blood pressure, temperature, weight, and symptoms, but only patients in the remote monitoring group were monitored by a respiratory therapist. All patients were assessed at baseline and at 3 and 6 months after program initiation. Outcomes included self-management skills, as measured by the Partners in Health (PIH) Scale; patient symptoms measured with the St George's Respiratory Questionnaire (SGRQ); and the Bristol COPD Knowledge Questionnaire (BCKQ). Patients were also asked to self-report on health system use, and data on health use were collected from the hospital.
RESULTS
A total of 122 patients participated in the study: 40 in the standard care, 41 in the self-monitoring, and 41 in the remote monitoring groups. Although all 3 groups improved in PIH scores, BCKQ scores, and SGRQ impact scores, there were no significant differences among any of the groups. No effects were observed on the SGRQ activity or symptom scores or on hospitalizations, ED visits, or clinic visits.
CONCLUSIONS
Despite regular use of the technology, patients with COPD assigned to remote monitoring or self-monitoring did not have any improvement in patient outcomes such as self-management skills, knowledge, or symptoms, or in health care use compared with each other or with a standard care group. This may be owing to low health care use at baseline, the lack of structured educational components in the intervention groups, and the lack of integration of the action plan with the technology.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03741855; https://clinicaltrials.gov/ct2/show/ NCT03741855.",2020,"No effects were observed on the SGRQ activity or symptom scores or on hospitalizations, ED visits, or clinic visits.
","['Chronic obstructive pulmonary disease (COPD', 'patients with COPD compared with a standard care group', 'Patients with COPD were recruited from outpatient clinics and a pulmonary rehabilitation program', '122 patients participated in the study: 40 in the standard care, 41 in the self-monitoring, and 41 in the remote monitoring groups', 'Chronic Obstructive Pulmonary Disease']","['technology-enabled self-monitoring program versus a technology-enabled remote monitoring program', 'remote monitoring and a self-monitoring program relative to standard care']","['PIH scores, BCKQ scores, and SGRQ impact scores', 'SGRQ activity or symptom scores or on hospitalizations, ED visits, or clinic visits', ""self-management skills, as measured by the Partners in Health (PIH) Scale; patient symptoms measured with the St George's Respiratory Questionnaire (SGRQ); and the Bristol COPD Knowledge Questionnaire (BCKQ"", 'Bluetooth-enabled device kit to monitor oxygen saturation, blood pressure, temperature, weight, and symptoms', 'COPD exacerbations']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}]",122.0,0.0434727,"No effects were observed on the SGRQ activity or symptom scores or on hospitalizations, ED visits, or clinic visits.
","[{'ForeName': 'Vess', 'Initials': 'V', 'LastName': 'Stamenova', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Liang', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Engel', 'Affiliation': 'Respiratory Therapy Department, Markham Stouffville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'van Lieshout', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lalingo', 'Affiliation': 'Medicine, Care Transitions, Access & Flow, Respiratory Therapy, Markham Stouffville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Cheung', 'Affiliation': 'Respiratory Therapy Department, Markham Stouffville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Erwood', 'Affiliation': 'Support Services & Transformation, Markham Stouffville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Radina', 'Affiliation': 'Center for Respiratory Health, Markham Stouffville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Greenwald', 'Affiliation': 'Center for Respiratory Health, Markham Stouffville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Payal', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Sidhu', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'R Sacha', 'Initials': 'RS', 'LastName': 'Bhatia', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Shafai', 'Affiliation': 'Hospital to Home and Community Medicine Clinic, Markham Stouffville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Onil', 'Initials': 'O', 'LastName': 'Bhattacharyya', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}]",Journal of medical Internet research,['10.2196/18598']
2458,32727493,Implementation of family psychosocial risk assessment in pediatric cancer with the Psychosocial Assessment Tool (PAT): study protocol for a cluster-randomized comparative effectiveness trial.,"BACKGROUND
Childhood cancer affects and is affected by multiple levels of the social ecology, including social and relational determinants of health (e.g., economic stability, housing, childcare, healthcare access, child and family problems). The 2015 Standards of Psychosocial Care in Pediatric Cancer outline optimal psychosocial care sensitive to these ecological factors, starting with assessment of psychosocial healthcare needs to promote medical and psychosocial outcomes across all children with cancer. To address the first standard of family psychosocial assessment, the Psychosocial Assessment Tool (PAT) is a validated screener ready for broad implementation.
METHOD
The PAT will be implemented across a national sample of 18 pediatric cancer programs ranging in size (annual new patients) in a mixed methods, comparative effectiveness study, guided by the Interactive Systems Framework for Dissemination and Implementation, comparing two implementation strategies. It is hypothesized that implementation will be more successful at the patient/family, provider, and institutional level when training (strategy I) is combined with implementation expanded resources (strategy II). There are three aims: (1) Refine the two implementation strategies using semi-structured qualitative interviews with 19 stakeholders including parent advocates, providers, pediatric oncology organization representatives, healthcare industry leaders; (2) Compare the two theoretically based and empirically informed strategies to implement the PAT in English and Spanish using a cluster-randomized controlled trial across 18 sites. Stratified by size, sites will be randomized to cohort (3) and strategy (2). Outcomes include adoption and penetration of screening (patient/family), staff job satisfaction/burnout (provider), and cost-effective use of resources consistent with family risk (institution); (3) Based on the results of the trial and feedback from the first and second aim, we will develop and disseminate a web-based PAT Implementation Toolkit.
DISCUSSION
Use of the PAT across children's cancer programs nationally can achieve the assessment standard and inform equitable delivery of psychosocial care matched to family need for all patients.
TRIAL REGISTRATION
ClinicalTrials.gov , NCT04446728 , registered 23 June 2020.",2020,It is hypothesized that implementation will be more successful at,"['18 pediatric cancer programs ranging in size (annual new patients', 'children with cancer', 'pediatric cancer with the Psychosocial Assessment Tool (PAT']","['PAT', 'Psychosocial Assessment Tool (PAT']","['adoption and penetration of screening (patient/family), staff job satisfaction/burnout (provider), and cost-effective use of resources consistent with family risk (institution']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1455743', 'cui_str': 'Psychosocial assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C1455743', 'cui_str': 'Psychosocial assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]",18.0,0.0715876,It is hypothesized that implementation will be more successful at,"[{'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Kazak', 'Affiliation': ""Nemours Children's Health System, Wilmington, DE, USA. anne.kazak@nemours.org.""}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Deatrick', 'Affiliation': 'University of Pennsylvania School of Nursing, Philadelphia, PA, USA.'}, {'ForeName': 'Michele A', 'Initials': 'MA', 'LastName': 'Scialla', 'Affiliation': 'A.I. du Pont Hospital for Children, Wilmington, DE, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Sandler', 'Affiliation': ""Nemours Children's Clinic, Jacksonville, FL, USA.""}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Madden', 'Affiliation': ""The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Lamia P', 'Initials': 'LP', 'LastName': 'Barakat', 'Affiliation': ""The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}]",Implementation science : IS,['10.1186/s13012-020-01023-w']
2459,32723722,Virtual Reality Smartphone-Based Intervention for Smoking Cessation: Pilot Randomized Controlled Trial on Initial Clinical Efficacy and Adherence.,"BACKGROUND
Obstacles to current tobacco cessation programs include limited access and adherence to effective interventions. Digital interventions offer a great opportunity to overcome these difficulties, yet virtual reality has not been used as a remote and self-administered tool to help increase adherence and effectiveness of digital interventions for tobacco cessation.
OBJECTIVE
This study aimed to evaluate participant adherence and smoking cessation outcomes in a pilot randomized controlled trial of the digital intervention Mindcotine (MindCotine Inc) using a self-administered treatment of virtual reality combined with mindfulness.
METHODS
A sample of 120 participants was recruited in the city of Buenos Aires, Argentina (mean age 43.20 years, SD 9.50; 57/120, 47.5% female). Participants were randomly assigned to a treatment group (TG), which received a self-assisted 21-day program based on virtual reality mindful exposure therapy (VR-MET) sessions, daily surveys, and online peer-to-peer support moderated by psychologists, or a control group (CG), which received the online version of the smoking cessation manual from the Argentine Ministry of Health. Follow-up assessments were conducted by online surveys at postintervention and 90-day follow-up. The primary outcome was self-reported abstinence at postintervention, with missing data assumed as still smoking. Secondary outcomes included sustained abstinence at 90-day follow-up, adherence to the program, and readiness to quit.
RESULTS
Follow-up rates at day 1 were 93% (56/60) for the TG and 100% (60/60) for the CG. At postintervention, the TG reported 23% (14/60) abstinence on that day compared with 5% (3/60) in the CG. This difference was statistically significant (χ 2 1 =8.3; P=.004). The TG reported sustained abstinence of 33% (20/60) at 90 days. Since only 20% (12/60) of participants in the CG completed the 90-day follow-up, we did not conduct a statistical comparison between groups at this follow-up time point. Among participants still smoking at postintervention, the TG was significantly more ready to quit compared to the CG (TG: mean 7.71, SD 0.13; CG: mean 7.16, SD 0.13; P=.005). A total of 41% (23/56) of participants completed the treatment in the time frame recommended by the program.
CONCLUSIONS
Results provide initial support for participant adherence to and efficacy of Mindcotine and warrant testing the intervention in a fully powered randomized trial. However, feasibility of trial follow-up assessment procedures for control group participants needs to be improved. Further research is needed on the impact of VR-MET on long-term outcomes.
TRIAL REGISTRATION
ISRCTN Registry ISRCTN50586181; http://www.isrctn.com/ISRCTN50586181.",2020,"Among participants still smoking at postintervention, the TG was significantly more ready to quit compared to the CG (TG: mean 7.71, SD 0.13; CG: mean 7.16, SD 0.13; P=.005).","['A sample of 120 participants was recruited in the city of Buenos Aires, Argentina (mean age 43.20 years, SD 9.50; 57/120, 47.5% female', 'Smoking Cessation']","['digital intervention Mindcotine (MindCotine Inc', 'Virtual Reality Smartphone-Based Intervention', 'virtual reality combined with mindfulness', 'self-assisted 21-day program based on virtual reality mindful exposure therapy (VR-MET) sessions, daily surveys, and online peer-to-peer support moderated by psychologists, or a control group (CG), which received the online version of the smoking cessation manual from the Argentine Ministry of Health', 'Mindcotine']","['self-reported abstinence at postintervention, with missing data assumed as still smoking', 'ready to quit', 'sustained abstinence at 90-day follow-up, adherence to the program, and readiness to quit']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1741275', 'cui_str': 'AIRE protein, human'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}]",120.0,0.0805419,"Among participants still smoking at postintervention, the TG was significantly more ready to quit compared to the CG (TG: mean 7.71, SD 0.13; CG: mean 7.16, SD 0.13; P=.005).","[{'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Goldenhersch', 'Affiliation': 'Laboratorio de Investigación en Neurociencia y Ciencias Sociales, Universidad de Flores, Ciudad Autónoma de Buenos Aires, Argentina.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Thrul', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Ungaretti', 'Affiliation': 'Facultad de Psicología, Universidad de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rosencovich', 'Affiliation': 'Escuela de Ingeniería Biomédica, Universidad Nacional de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Waitman', 'Affiliation': 'Universidad Siglo XXI, Córdoba, Argentina.'}, {'ForeName': 'Marcelo Rodriguez', 'Initials': 'MR', 'LastName': 'Ceberio', 'Affiliation': 'Laboratorio de Investigación en Neurociencia y Ciencias Sociales, Universidad de Flores, Ciudad Autónoma de Buenos Aires, Argentina.'}]",Journal of medical Internet research,['10.2196/17571']
2460,32723723,Acceptance and Commitment Therapy Delivered via a Mobile Phone Messaging Robot to Decrease Postoperative Opioid Use in Patients With Orthopedic Trauma: Randomized Controlled Trial.,"BACKGROUND
Acceptance and commitment therapy (ACT) is a pragmatic approach to help individuals decrease avoidable pain.
OBJECTIVE
This study aims to evaluate the effects of ACT delivered via an automated mobile messaging robot on postoperative opioid use and patient-reported outcomes (PROs) in patients with orthopedic trauma who underwent operative intervention for their injuries.
METHODS
Adult patients presenting to a level 1 trauma center who underwent operative fixation of a traumatic upper or lower extremity fracture and who used mobile phone text messaging were eligible for the study. Patients were randomized in a 1:1 ratio to either the intervention group, who received twice-daily mobile phone messages communicating an ACT-based intervention for the first 2 weeks after surgery, or the control group, who received no messages. Baseline PROs were completed. Two weeks after the operative intervention, follow-up was performed in the form of an opioid medication pill count and postoperative administration of PROs. The mean number of opioid tablets used by patients was calculated and compared between groups. The mean PRO scores were also compared between the groups.
RESULTS
A total of 82 subjects were enrolled in the study. Of the 82 participants, 76 (38 ACT and 38 controls) completed the study. No differences between groups in demographic factors were identified. The intervention group used an average of 26.1 (SD 21.4) opioid tablets, whereas the control group used 41.1 (SD 22.0) tablets, resulting in 36.5% ([41.1-26.1]/41.1) less tablets used by subjects receiving the mobile phone-based ACT intervention (P=.004). The intervention group subjects reported a lower postoperative Patient-Reported Outcome Measure Information System Pain Intensity score (mean 45.9, SD 7.2) than control group subjects (mean 49.7, SD 8.8; P=.04).
CONCLUSIONS
In this study, the delivery of an ACT-based intervention via an automated mobile messaging robot in the acute postoperative period decreased opioid use in selected patients with orthopedic trauma. Participants receiving the ACT-based intervention also reported lower pain intensity after 2 weeks, although this may not represent a clinically important difference.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03991546; https://clinicaltrials.gov/ct2/show/NCT03991546.",2020,"The intervention group subjects reported a lower postoperative Patient-Reported Outcome Measure Information System Pain Intensity score (mean 45.9, SD 7.2) than control group subjects (mean 49.7, SD 8.8; P=.04).
","['patients with orthopedic trauma who underwent operative intervention for their injuries', 'Patients', '82 participants, 76 (38 ACT and 38 controls) completed the study', 'Adult patients presenting to a level 1 trauma center who underwent operative fixation of a traumatic upper or lower extremity fracture and who used mobile phone text messaging were eligible for the study', 'selected patients with orthopedic trauma', 'A total of 82 subjects were enrolled in the study']","['commitment therapy (ACT', 'mobile phone-based ACT intervention', 'ACT-based intervention', 'ACT delivered via an automated mobile messaging robot', 'ACT-based intervention via an automated mobile messaging robot', 'twice-daily mobile phone messages communicating an ACT-based intervention']","['lower postoperative Patient-Reported Outcome Measure Information System Pain Intensity score', 'pain intensity', 'mean number of opioid tablets', 'Postoperative Opioid Use', 'mean PRO scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1542178', 'cui_str': 'Fracture of lower leg'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}]","[{'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]",82.0,0.223987,"The intervention group subjects reported a lower postoperative Patient-Reported Outcome Measure Information System Pain Intensity score (mean 45.9, SD 7.2) than control group subjects (mean 49.7, SD 8.8; P=.04).
","[{'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Anthony', 'Affiliation': 'Department of Orthopaedics, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Edward Octavio', 'Initials': 'EO', 'LastName': 'Rojas', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, United States.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Keffala', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, United States.'}, {'ForeName': 'Natalie Ann', 'Initials': 'NA', 'LastName': 'Glass', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, United States.'}, {'ForeName': 'Apurva S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""Children's Hospital of Philadelphia Main Campus Division of Orthopaedics, Philadelphia, PA, United States.""}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Miller', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hogue', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, United States.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Willey', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Karam', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, United States.'}, {'ForeName': 'John Lawrence', 'Initials': 'JL', 'LastName': 'Marsh', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, United States.'}]",Journal of medical Internet research,['10.2196/17750']
2461,32728226,"A randomised, prospective study of 'off-the-shelf' use of toric intraocular lenses for cataract patients with pre-existing corneal astigmatism in the NHS.","BACKGROUND/OBJECTIVES
To compare visual and refractive outcomes of monofocal intraocular lenses (IOLs) with limbal relaxing incisions (LRI) with 'off-the-shelf' use of toric IOLs (TIOLs), with a fixed 2-dioptre cylinder (DC) correction, for cataract patients with pre-existing corneal astigmatism in a public-sector setting.
SUBJECTS/METHODS
Seventy-seven patients (77 eyes, first treated eye) with visually significant cataract and pre-operative corneal astigmatism ≥2.00 DC were randomised to receive either 'off-the-shelf' TIOLs, with a fixed 2.00 DC cylinder correction (39 eyes), or monofocal IOLs (38 eyes) with LRIs. The concept of fixing the cylindrical correction was to minimise costs, allow a full TIOL bank to be available and eliminate the need for individual TIOL ordering. Outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA) and refraction. Astigmatic changes were evaluated using the Alpins vector method.
RESULTS
Mean UDVA improved from logMAR 0.88 (SD 0.56)[~20/150] pre-operatively to 0.18 (SD 0.19)[~20/30] post-operatively in TIOL group, versus 0.82 (SD 0.55)[~20/130] to 0.27 (SD 0.15)[~20/40] in monofocal/LRI group (P = 0.02; 95% CI: -0.17, -0.01). Mean CDVA improved from logMAR 0.40 (SD 0.26)[~20/50] to 0.01 (SD 0.12)[~20/20] in TIOL group, and 0.41 (SD 0.38)[~20/40] to 0.06 (SD 0.12)[~20/25] in LRI group (P = 0.07; 95% CI: -0.11, 0.01). Average post-operative refractive cylinder in TIOL group was 1.35 DC (SD 0.84 DC) and in LRI group 1.91 DC (SD 1.07 DC) (P = 0.01; 95% CI: -1, -0.12). Mean difference vector magnitude was 1.92 DC (SD 1.08 DC) in LRI group and 1.37 DC (SD 0.84 DC) in TIOL group (P = 0.02; 95% CI: 0.11, 0.99).
CONCLUSIONS
TIOLs with a fixed 2.00 DC correction during cataract surgery may improve UDVA, reduce post-operative cylinder and result in a more reliable astigmatic correction compared with monofocal IOLs with LRIs.",2020,"RESULTS
Mean UDVA improved from logMAR 0.88 (SD 0.56)[~20/150] pre-operatively to 0.18","['Seventy-seven patients (77 eyes, first treated eye) with visually significant cataract and pre-operative corneal astigmatism', 'cataract patients with pre-existing corneal astigmatism in the NHS', 'cataract patients with pre-existing corneal astigmatism in a public-sector setting']","['fixed 2.00 DC cylinder correction (39 eyes), or monofocal IOLs (38 eyes) with LRIs', 'monofocal intraocular lenses (IOLs) with limbal relaxing incisions (LRI', 'toric IOLs (TIOLs), with a fixed 2-dioptre cylinder (DC) correction', 'toric intraocular lenses']","['Mean difference vector magnitude', 'uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA) and refraction', 'Mean CDVA', 'Mean UDVA']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0443251', 'cui_str': 'Limbal'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}]",,0.196616,"RESULTS
Mean UDVA improved from logMAR 0.88 (SD 0.56)[~20/150] pre-operatively to 0.18","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Stanojcic', 'Affiliation': ""Department of Ophthalmology, King's College London Frost Eye Research Unit, Guy's and St Thomas' NHS Foundation Trust, Lambeth Palace Road, London, SE1 7EH, UK. nstanojcic@doctors.org.uk.""}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Roberts', 'Affiliation': ""Department of Ophthalmology, King's College London Frost Eye Research Unit, Guy's and St Thomas' NHS Foundation Trust, Lambeth Palace Road, London, SE1 7EH, UK.""}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Wagh', 'Affiliation': ""Department of Ophthalmology, King's College London Frost Eye Research Unit, Guy's and St Thomas' NHS Foundation Trust, Lambeth Palace Road, London, SE1 7EH, UK.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Zuberbuhler', 'Affiliation': 'Zubimed Augenzentrum, Niederhasli, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""O'Brart"", 'Affiliation': ""Department of Ophthalmology, King's College London Frost Eye Research Unit, Guy's and St Thomas' NHS Foundation Trust, Lambeth Palace Road, London, SE1 7EH, UK.""}]","Eye (London, England)",['10.1038/s41433-020-0919-8']
2462,32722634,Effects of an Unstructured Free Play and Mindfulness Intervention on Wellbeing in Kindergarten Students.,"Play is known as the core occupation of young children as it lays a foundation for their early development and physical, emotional and social wellbeing. Literature suggests that unstructured free play and mindfulness interventions may independently promote wellbeing among preschoolers. However, there is no clear evidence of their combination in supporting wellness in early learning environments. We conducted a quasi-experimental study with 42 children aged four to six years, attending two kindergartens in Hong Kong. The intervention included unstructured play with non-directional loose parts (play materials), conducted outdoors for one hour daily followed by a mindfulness intervention for 10 min per day indoors. The intervention lasted for five consecutive days. We examined happiness and aspects of playfulness before and after the intervention, finding a significant increase in all areas. Given greater freedom in play choice, children showed more disruptive behaviors during unstructured play than the control group engaging in recess as usual. We conclude that unstructured play in addition to mindfulness intervention is effective in promoting students' happiness and playfulness, both of which may help maintain mental health and wellbeing amid stressors such as transition and separation. The increased disruptive behavior requires additional investigation.",2020,"Given greater freedom in play choice, children showed more disruptive behaviors during unstructured play than the control group engaging in recess as usual.","['Kindergarten Students', '42 children aged four to six years, attending two kindergartens in Hong Kong']","['Unstructured Free Play and Mindfulness Intervention', 'unstructured play with non-directional loose parts (play materials), conducted outdoors for one hour daily followed by a mindfulness intervention']",['disruptive behaviors'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}]",42.0,0.0184046,"Given greater freedom in play choice, children showed more disruptive behaviors during unstructured play than the control group engaging in recess as usual.","[{'ForeName': 'Regina Lai Tong', 'Initials': 'RLT', 'LastName': 'Lee', 'Affiliation': 'School of Nursing and Midwifery, Faculty of Health and Medicine, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Shelly Jerrine', 'Initials': 'SJ', 'LastName': 'Lane', 'Affiliation': 'College of Health and Human Sciences, Colorado State University, Fort Collins, CO 80526, USA.'}, {'ForeName': 'Anson Chiu Yan', 'Initials': 'ACY', 'LastName': 'Tang', 'Affiliation': 'School of Nursing, Tung Wah College, Hong Kong, China.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Leung', 'Affiliation': 'Department of Social Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Lobo Hung Tak', 'Initials': 'LHT', 'LastName': 'Louie', 'Affiliation': 'Department of Physical Education, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Browne', 'Affiliation': 'School of Nursing and Midwifery, Faculty of Health and Medicine, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Sally Wai Chi', 'Initials': 'SWC', 'LastName': 'Chan', 'Affiliation': 'University of Newcastle Singapore Pte Limited, Singapore 038986, Singapore.'}]",International journal of environmental research and public health,['10.3390/ijerph17155382']
2463,32723728,Teens Taking Charge: A Randomized Controlled Trial of a Web-Based Self-Management Program With Telephone Support for Adolescents With Juvenile Idiopathic Arthritis.,"BACKGROUND
Juvenile idiopathic arthritis (JIA) is a serious and potentially debilitating pediatric illness. Improved disease self-management may help to improve health outcomes.
OBJECTIVE
This study aimed to evaluate the effectiveness of the Teens Taking Charge Web-based self-management intervention in reducing symptoms and improving health-related quality of life (HRQL) in adolescents with JIA compared with a Web-based education control condition.
METHODS
Adolescents with JIA aged 12 to 18 years were recruited from 11 Canadian pediatric rheumatology centers. Caregivers were invited to participate along with their child. In addition to standard medical care, participants were randomized to receive either (1) the Teens Taking Charge self-management intervention or (2) a Web-based education control condition for a period of 12 weeks. Adolescents in the intervention group completed website modules addressing cognitive behavioral coping skills, stress management, and other self-management topics, while also receiving monthly telephone calls from a trained health coach. Adolescents in the education control group were instructed to view a series of preselected public JIA educational websites and received monthly calls from a coach who asked about their own best efforts at managing JIA. Caregivers in the intervention group completed website modules related to promoting independence and disease self-management in their child. Caregivers in the education control group were instructed to view a series of preselected public JIA educational websites. Outcome assessment occurred at baseline, 12 weeks (posttreatment), and at 6 and 12 months postrandomization. The primary outcomes were pain intensity, pain interference, and HRQL. Secondary outcomes were emotional symptoms, adherence, coping, knowledge, and self-efficacy.
RESULTS
In total, 333 adolescents and 306 caregivers were enrolled. Significant overall reductions in pain intensity (P=.02) and pain interference (P=.007) were observed for intervention group participants compared with those in the education control group, after adjusting for baseline levels. There was a significant overall improvement in HRQL related to problems with pain (P=.02) and problems with daily activities (P=.01). There was also a significant difference in the intervention group over time (P=.008) for HRQL related to treatment problems, with the intervention group participants demonstrating improved HRQL by 12 months compared with education control group participants. Both groups showed nonsignificant improvements compared with baseline in other primary outcomes. There were no significant differences between the groups in any secondary outcomes or caregiver-reported outcomes.
CONCLUSIONS
The results of this randomized trial suggest that the Teens Taking Charge Web-based intervention is effective at reducing both pain intensity and pain interference, as well as improving HRQL in adolescents with JIA, compared with education control. These effects are sustained for up to 12 months following program completion. The Teens Taking Charge program is now publicly available at no cost.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01572896; https://clinicaltrials.gov/ct2/show/NCT01572896.",2020,"Significant overall reductions in pain intensity (P=.02) and pain interference (P=.007) were observed for intervention group participants compared with those in the education control group, after adjusting for baseline levels.","['adolescents with JIA compared with a Web-based education control condition', 'Adolescents with JIA aged 12 to 18 years were recruited from 11 Canadian pediatric rheumatology centers', '333 adolescents and 306 caregivers were enrolled', 'Adolescents With Juvenile Idiopathic Arthritis', 'Teens Taking Charge']","['Web-Based Self-Management Program With Telephone Support', 'website modules addressing cognitive behavioral coping skills, stress management, and other self-management topics, while also receiving monthly telephone calls from a trained health coach', 'Teens Taking Charge Web-based self-management intervention', 'preselected public JIA educational websites and received monthly calls from a coach who asked about their own best efforts at managing JIA', 'Teens Taking Charge self-management intervention or (2) a Web-based education control condition']","['symptoms and improving health-related quality of life (HRQL', 'pain intensity, pain interference, and HRQL', 'pain intensity', 'emotional symptoms, adherence, coping, knowledge, and self-efficacy', 'HRQL', 'pain interference', 'pain intensity and pain interference']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1621271', 'cui_str': 'Pediatric rheumatology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0007961', 'cui_str': 'Charges'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",333.0,0.115157,"Significant overall reductions in pain intensity (P=.02) and pain interference (P=.007) were observed for intervention group participants compared with those in the education control group, after adjusting for baseline levels.","[{'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Stinson', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Lalloo', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Amos S', 'Initials': 'AS', 'LastName': 'Hundert', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Campillo', 'Affiliation': ""Montreal Children's Hospital, Montreal, QC, Canada.""}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Cellucci', 'Affiliation': 'Department of Pediatrics, Division of Rheumatology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dancey', 'Affiliation': ""Department of Pediatrics, Division of Rheumatology, Memorial University of Newfoundland, St. John's, NL, Canada.""}, {'ForeName': 'Ciaran', 'Initials': 'C', 'LastName': 'Duffy', 'Affiliation': 'Department of Pediatrics, Division of Rheumatology, McGill Research Institute, Montreal, QC, Canada.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Ellsworth', 'Affiliation': 'Department of Pediatrics, Division of Rheumatology, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Feldman', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Huber', 'Affiliation': 'IWK Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Johnson', 'Affiliation': ""Alberta Children's Hospital, Calgary, AB, Canada.""}, {'ForeName': ""Geert't"", 'Initials': 'G', 'LastName': 'Jong', 'Affiliation': ""Children's Hospital Research Institute of Manitoba, Winnipeg, MB, Canada.""}, {'ForeName': 'Kiem', 'Initials': 'K', 'LastName': 'Oen', 'Affiliation': 'Pediatrics and Child Health, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Rosenberg', 'Affiliation': 'University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Shiff', 'Affiliation': 'Biobehavioral Nursing Science, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Spiegel', 'Affiliation': 'Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Shirley M L', 'Initials': 'SML', 'LastName': 'Tse', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Tucker', 'Affiliation': 'Department of Pediatrics, Division of Rheumatology, University of British Columbia, Vancouver, ON, Canada.'}, {'ForeName': 'Joseph Charles', 'Initials': 'JC', 'LastName': 'Victor', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.'}]",Journal of medical Internet research,['10.2196/16234']
2464,32729749,Cost-utility analysis of normothermic liver perfusion with the OrganOx metra compared to static cold storage in the United Kingdom.,"BACKGROUND
Rising numbers of patients on the liver transplant waiting list has led to the utilization of organs from higher-risk donors that are more likely to be discarded and are prone to post-transplant complications. Storage and transportation of these livers at low temperatures can cause damage. OrganOx metra is a portable device intended to preserve and maintain the donated liver in normothermic conditions for up to 24 h prior to transplantation.
OBJECTIVE
To evaluate the cost-utility of normothermic machine perfusion with OrganOx metra in liver transplantation compared to the current practice of static cold storage (SCS).
METHODS
A de novo decision analytic model (a decision tree along with a Markov model), based on current treatment pathways, was developed to estimate the costs and outcomes. Results from a randomized clinical trial and national standard sources were used to inform the model. Costs were estimated from the National Health Service and Personal Social Services perspective. Deterministic and probabilistic sensitivity analyses (PSA) were conducted to explore uncertainty surrounding input parameters.
RESULTS
Over a lifetime time horizon, liver transplantation with OrganOx metra was more costly and more effective than the current practice of static cold storage. The total costs per patient were £37,370 vs £46,711, and the total effectiveness per patient was 9.09 QALYs vs 10.27 QALYs for SCS and OrganOx metra groups, respectively. The estimated ICER was £7,876 per each QALY gained. Results from the PSA showed that use of OrganOx metra has 99% probability of being cost-effective at a £20,000 willingness-to-pay threshold. OrganOx metra led to the utilization of 54 additional livers with patients experiencing lower rates of early allograft dysfunction and adverse events.
CONCLUSIONS
Use of OrganOx metra for the perfusion and transportation of livers prior to transplantation is a cost-effective strategy. KEY POINTS FOR DECISION MAKERS Introduction of OrganOx metra into NHS could increase the utilisation of donated livers with patients experiencing lower rates of early allograft dysfunction and adverse events, compared with current practice. Results of the economic analysis indicate that the OrganOx metra is highly likely to be cost-effective and result in improved patient outcomes.",2020,OrganOx metra led to the utilisation of 54 additional livers with patients experiencing lower rates of early allograft dysfunction and adverse events.,[],"['OrganOx metra', 'normothermic machine perfusion with OrganOx metra', 'OrganOx']","['total costs per patient', 'early allograft dysfunction and adverse events']",[],"[{'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.035054,OrganOx metra led to the utilisation of 54 additional livers with patients experiencing lower rates of early allograft dysfunction and adverse events.,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Javanbakht', 'Affiliation': 'Optimax Access UK Ltd, University of Southampton Science Park, Chilworth, UK.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Mashayekhi', 'Affiliation': 'Optimax Access UK Ltd, University of Southampton Science Park, Chilworth, UK.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Trevor', 'Affiliation': 'School of Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Branagan-Harris', 'Affiliation': 'Device Access UK Ltd, Market Access Consultancy, University of Southampton Science Park, Chilworth, UK.'}, {'ForeName': 'Jowan', 'Initials': 'J', 'LastName': 'Atkinson', 'Affiliation': 'Device Access UK Ltd, Market Access Consultancy, University of Southampton Science Park, Chilworth, UK.'}]",Journal of medical economics,['10.1080/13696998.2020.1804391']
2465,32729784,Postprandial glycemia and insulin secretion following glutamine administration: A randomized controlled trial.,"Objective : The objective of the present study is to investigate the effects of glutamine administration on postprandial glycemia, insulin, and C-peptide concentration in patients with type 2 diabetes. Methods : A randomized, double-blind, placebo-controlled trial was conducted on patients with type 2 diabetes so that 33 subjects were recruited in each group. The patients were randomly allocated to receive either 30 g/d glutamine or placebo (with instructions to take in half glass of ice-cold water 5 to 10 min before each main meal) for 6 weeks. Postprandial C-peptide, insulin, and glucose were measured at the baseline and at the end of the study at 30 and 90 min after consuming a meal comprising wheat-cake and reduced fat milk. Results : The repeated measures ANOVA revealed no significant difference between the groups for glucose and insulin after 6 weeks of intervention ( p > 0.05). However, C-peptide was reduced in both intervention groups at all measurement points. Between-group differences remained significant by the end of the study ( p = 0.02). Conclusions : Glutamine supplementation before each main meal does not represent an effective nutritional strategy to improve postprandial glycemic control or postprandial insulin secretion in type 2 diabetes patients.",2020,The repeated measures ANOVA revealed no significant difference between the groups for glucose and insulin after 6 weeks of intervention ( p > 0.05).,"['type 2 diabetes patients', 'patients with type 2 diabetes so that 33 subjects were recruited in each group', 'patients with type 2 diabetes']","['glutamine', 'glutamine administration', '30\xa0g/d glutamine or placebo', 'placebo']","['Postprandial glycemia and insulin secretion', 'postprandial glycemia, insulin, and C-peptide concentration', 'postprandial glycemic control or postprandial insulin secretion', 'Postprandial C-peptide, insulin, and glucose', 'glucose and insulin', 'C-peptide']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.235122,The repeated measures ANOVA revealed no significant difference between the groups for glucose and insulin after 6 weeks of intervention ( p > 0.05).,"[{'ForeName': 'Asieh', 'Initials': 'A', 'LastName': 'Mansour', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohajeri-Tehrani', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Qorbani', 'Affiliation': 'Department of Biostatistics and Epidemiology, Non-communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Ghamari', 'Affiliation': 'Student Research Committee Faculty of Medical Urima, University of Medical Sciences, Uremia, Iran.'}, {'ForeName': 'Bagher', 'Initials': 'B', 'LastName': 'Larijani', 'Affiliation': 'Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Hosseini', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}]",International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition,['10.1024/0300-9831/a000463']
2466,32727835,Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis: The VELOCE study.,"OBJECTIVE
The phase IIIb A Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Participants With Relapsing Forms of Multiple Sclerosis (VELOCE) study (NCT02545868) assessed responses to selected vaccines in ocrelizumab (OCR)-treated patients with relapsing multiple sclerosis.
METHODS
Patients were randomized 2:1 into the OCR group (n = 68; OCR 600 mg) or control group (n = 34; interferon beta or no disease-modifying therapy). All received tetanus toxoid (TT)-containing vaccine, Pneumovax (23-valent pneumococcal polysaccharide vaccine [23-PPV]), and keyhole limpet hemocyanin (KLH). The OCR group was subdivided into OCR1 (n = 33) and OCR2 (n = 35) at randomization. The OCR1 group received Prevnar (13-valent conjugate pneumococcal vaccine) 4 weeks after 23-PPV; the OCR2 and control groups received influenza vaccine. Vaccinations started 12 weeks after OCR initiation (OCR group) or on day 1 (control group).
RESULTS
Positive response rate to TT vaccine at 8 weeks was 23.9% in the OCR vs 54.5% in the control group. Positive response rate to ≥5 serotypes in 23-PPV at 4 weeks was 71.6% in the OCR and 100% in the control group. Prevnar did not enhance response to pneumococcal serotypes in common with Pneumovax. Humoral response to KLH was decreased in the OCR vs control group. Seroprotection rates at 4 weeks against 5 influenza strains ranged from 55.6% to 80.0% in the OCR2 group and 75.0% to 97.0% in the control group.
CONCLUSION
Peripherally B-cell-depleted OCR recipients mounted attenuated humoral responses to clinically relevant vaccines and the neoantigen KLH, suggesting that use of standard nonlive vaccines while on OCR treatment remains a consideration. For seasonal influenza vaccines, it is recommended to vaccinate patients on OCR because a potentially protective humoral response, even if attenuated, can be expected.
CLASSIFICATION OF EVIDENCE
This study provides Class II evidence confirming that the humoral response to nonlive vaccines in patients with relapsing multiple sclerosis after OCR treatment is attenuated compared with untreated or interferon beta-treated patients, but they can still be expected to be protective.
CLINICALTRIALSGOV IDENTIFIER
NCT02545868.",2020,"RESULTS
Positive response rate to TT vaccine at 8 weeks was 23.9% in OCR vs 54.5% in Control.","['patients with multiple sclerosis', 'Patients were randomized 2:1 into Group OCR (n=68', 'ocrelizumab (OCR)-treated patients with relapsing multiple sclerosis']","['interferon-β or no disease-modifying therapy', 'tetanus toxoid (TT)-containing vaccine, Pneumovax® (23-PPV) and keyhole limpet hemocyanin (KLH', 'TT vaccine', 'influenza vaccine', 'OCR2', 'ocrelizumab', 'interferon-β-treated', 'OCR1 received Prevnar® (13-PCV']","['Humoral response to KLH', 'Seroprotection rates', 'Positive response rate', 'vaccine responses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0071315', 'cui_str': 'Pneumovax'}, {'cui': 'C0064332', 'cui_str': 'Keyhole-limpet hemocyanin'}, {'cui': 'C0305062', 'cui_str': 'tetanus toxoid vaccine, inactivated'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0876134', 'cui_str': 'Prevnar'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}]","[{'cui': 'C0064332', 'cui_str': 'Keyhole-limpet hemocyanin'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.0381286,"RESULTS
Positive response rate to TT vaccine at 8 weeks was 23.9% in OCR vs 54.5% in Control.","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bar-Or', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada. amitbar@pennmedicine.upenn.edu.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Calkwood', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Chognot', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Evershed', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Fox', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Herman', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Manfrini', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McNamara', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Derrick S', 'Initials': 'DS', 'LastName': 'Robertson', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Stokmaier', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Jeanette K', 'Initials': 'JK', 'LastName': 'Wendt', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Winthrop', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Traboulsee', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}]",Neurology,['10.1212/WNL.0000000000010380']
2467,32729615,Two weeks of early time-restricted feeding (eTRF) improves skeletal muscle insulin and anabolic sensitivity in healthy men.,"BACKGROUND
Altering the temporal distribution of energy intake (EI) and introducing periods of intermittent fasting (IF) exert important metabolic effects. Restricting EI to earlier in the day [early time-restricted feeding (eTRF)] is a novel type of IF.
OBJECTIVES
We assessed the chronic effects of eTRF compared with an energy-matched control on whole-body and skeletal muscle insulin and anabolic sensitivity.
METHODS
Sixteen healthy males (aged 23 ± 1 y; BMI 24.0 ± 0.6 kg·m-2) were assigned to 2 groups that underwent either 2 wk of eTRF (n = 8) or control/caloric restriction (CON:CR; n = 8) diet. The eTRF diet was consumed ad libitum and the intervention was conducted before the CON:CR, in which the diet was provided to match the reduction in EI and body weight observed in eTRF. During eTRF, daily EI was restricted to between 08:00 and 16:00, which prolonged the overnight fast by ∼5 h. The metabolic responses to a carbohydrate/protein drink were assessed pre- and post-interventions following a 12-h overnight fast.
RESULTS
When compared with CON:CR, eTRF improved whole-body insulin sensitivity [between-group difference (95% CI): 1.89 (0.18, 3.60); P = 0.03; η2p = 0.29] and skeletal muscle uptake of glucose [between-group difference (95% CI): 4266 (261, 8270) μmol·min-1·kg-1·180 min; P = 0.04; η2p = 0.31] and branched-chain amino acids (BCAAs) [between-group difference (95% CI): 266 (77, 455) nmol·min-1·kg-1·180 min; P = 0.01; η2p = 0.44]. eTRF caused a reduction in EI (∼400 kcal·d-1) and weight loss (-1.04 ± 0.25 kg; P = 0.01) that was matched in CON:CR (-1.24 ± 0.35 kg; P = 0.01).
CONCLUSIONS
Under free-living conditions, eTRF improves whole-body insulin sensitivity and increases skeletal muscle glucose and BCAA uptake. The metabolic benefits of eTRF are independent of its effects on weight loss and represent chronic adaptations rather than the effect of the last bout of overnight fast. This trial was registered at clinicaltrials.gov as NCT03969745.",2020,"Under free-living conditions, eTRF improves whole-body insulin sensitivity and increases skeletal muscle glucose and BCAA uptake.","['Sixteen healthy males (aged 23\xa0±\xa01 y', 'healthy men']","['early time-restricted feeding (eTRF', 'CON:CR, eTRF', 'eTRF (n\xa0=\xa08) or control/caloric restriction (CON:CR; n\xa0=\xa08) diet', 'eTRF']","['skeletal muscle glucose and BCAA uptake', 'whole-body insulin sensitivity', 'weight loss', 'branched-chain amino acids (BCAAs', 'skeletal muscle insulin and anabolic sensitivity', 'reduction in EI (∼400 kcal·d-1) and weight loss', 'skeletal muscle uptake of glucose']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0002845', 'cui_str': 'Anabolic steroid'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",16.0,0.0887892,"Under free-living conditions, eTRF improves whole-body insulin sensitivity and increases skeletal muscle glucose and BCAA uptake.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Pardeep', 'Initials': 'P', 'LastName': 'Pabla', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Mallinson', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Nixon', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Taylor', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Tsintzas', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa192']
2468,32726475,Effectiveness of Advance Care Planning Group Visits Among Older Adults in Primary Care.,"BACKGROUND
Group visits can support health behavior change and self-efficacy. In primary care, an advance care planning (ACP) group visit may leverage group dynamics and peer mentorship to facilitate education and personal goal setting that result in ACP engagement.
OBJECTIVE
To determine whether the ENgaging in Advance Care Planning Talks (ENACT) group visits intervention improves ACP documentation and readiness in older adults.
METHODS
This randomized clinical trial was conducted among geriatric primary care patients from the University of Colorado Hospital Seniors Clinic, Aurora, CO, from August 2017 to November 2019. Participants randomized to ENACT group visits (n = 55) participated in two 2-hour sessions with discussions of ACP topics and use of ACP tools (i.e., Conversation Starter Kit, Medical Durable Power of Attorney form, and PREPARE videos). Participants randomized to the control arm (n = 55) received the Conversation Starter Kit and a Medical Durable Power of Attorney form by mail. The primary outcomes included presence of ACP documents or medical decision-maker documentation in the electronic health record (EHR) at 6 months, and a secondary outcome was ACP readiness (validated four-item ACP Engagement Survey) at 6 months.
RESULTS
Participants were a mean of 77 years old, 60% female, and 79% white. At 6 months, 71% of ENACT participants had an advance directive in the EHR (26% higher) compared with 45% of control arm participants (P < .001). Similarly, 93% of ENACT participants had decision-maker documentation in the EHR (29% higher) compared with 73% in the control arm (P < .001). ENACT participants trended toward higher readiness to engage in ACP compared with control (4.56 vs 4.13; P = .16) at 6 months.
CONCLUSION
An ACP group visit increased ACP documentation and readiness to engage in ACP behavior change. Primary care teams can explore implementation and adaptation of ACP group visits into routine care, as well as longer-term impact on patient health outcomes.",2020,"ENACT participants trended toward higher readiness to engage in ACP compared with control (4.56 vs 4.13; P = .16) at 6 months.
","['geriatric primary care patients from the University of Colorado Hospital Seniors Clinic, Aurora, CO, from August 2017 to November 2019', 'Participants were a mean of 77\u2009years old, 60% female, and 79% white', 'older adults', 'Older Adults in Primary Care']","['discussions of ACP topics and use of ACP tools (i.e., Conversation Starter Kit, Medical Durable Power of Attorney form, and PREPARE videos', 'Conversation Starter Kit and a Medical Durable Power of Attorney form by mail', 'ENgaging in Advance Care Planning Talks (ENACT) group visits intervention', 'ACP', 'Advance Care Planning Group Visits', 'advance care planning (ACP) group visit may leverage group dynamics and peer mentorship to facilitate education and personal goal setting that result in ACP engagement', 'ENACT']","['readiness to engage in ACP', 'presence of ACP documents or medical decision-maker documentation in the electronic health record (EHR', 'decision-maker documentation', 'ACP documentation and readiness', 'ACP documentation and readiness to engage in ACP behavior change', 'advance directive in the EHR']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0586806', 'cui_str': 'Power of attorney observable'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0554244', 'cui_str': 'Maker'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}]",,0.0679267,"ENACT participants trended toward higher readiness to engage in ACP compared with control (4.56 vs 4.13; P = .16) at 6 months.
","[{'ForeName': 'Hillary D', 'Initials': 'HD', 'LastName': 'Lum', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Dukes', 'Affiliation': 'University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Daddato', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Juarez-Colunga', 'Affiliation': 'Division of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA.'}, {'ForeName': 'Prajakta', 'Initials': 'P', 'LastName': 'Shanbhag', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Kutner', 'Affiliation': 'Division of General Internal Medicine , Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Cari R', 'Initials': 'CR', 'LastName': 'Levy', 'Affiliation': 'Denver-Seattle Center of Innovation for Veteran-Centered and Value Driven Care, Eastern Colorado Health Care System, Aurora, Colorado, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16694']
2469,32727509,The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial.,"BACKGROUND
Prolonged exposure therapy (PE) is an evidence-based treatment for posttraumatic stress disorder (PTSD) that is underutilized in the military health system. Standard workshop training in PE may not be sufficient to alter provider behavior, but post-workshop consultation requires significant resources. Therefore, it is important to determine the incremental utility of post-workshop consultation.
METHODS
This study used a hybrid type III randomized implementation trial at 3 US Army installations. Providers were randomized to receive a 4-day prolonged exposure workshop (Standard training condition, n = 60), or the prolonged exposure workshop followed by 6-8 months of post-workshop expert case consultation (Extended training condition, n = 43). The effects training condition were examined on provider attitudes (self-efficacy in delivering PE, expectations for patient improvement, and beliefs about PE), use of PE and PE components, and clinical outcomes of patients with PTSD (using the Clinician-Administered PTSD Scale (CAPS-5)).
RESULTS
Extended condition providers reported greater improvements in self-efficacy, b = .83, 95% CI [.38, 1.27], t(79) = 3.71, p = .001, and d = .63. A greater proportion of patients in the Extended condition (44%) than in the Standard condition (27%) received at least 1 PE session, b = .76, t(233) = 2.53, p = .012, and OR = 2.13. Extended condition providers used more PE components (M = .9/session) than did Standard condition providers (M = .5/session), b = .54, 95% CI [.15, .93], t(68) = 2.70, p = .007, and d = .68. Finally, decrease in patients' PTSD symptoms was faster for patients of Extended condition providers than for patients of Standard condition providers, b = - 1.81, 95% CI [- 3.57, - .04], t(263) = - 2.02, p = .045, and d = .66, and their symptoms were lower at the second assessment, b = - 5.47, 95% CI [- 9.30, - 1.63], t(210) = - 2.81, p = .005, and d = .66.
CONCLUSIONS
Post-workshop consultation improved self-efficacy for delivering PE, greater use of PE, faster PTSD reduction, and lower PTSD severity at the second assessment. To our knowledge, this is the first demonstration that post-workshop case consultation for PE improves patient outcomes.
TRIAL REGISTRATION
Clinicaltrials.gov , NCT02982538 . Registered December 5, 2016; retrospectively registered.",2020,"RESULTS
Extended condition providers reported greater improvements in self-efficacy,",[],"['Prolonged exposure therapy (PE', '4-day prolonged exposure workshop (Standard training condition, n = 60), or the prolonged exposure workshop followed by 6-8\u2009months of post-workshop expert case consultation', 'prolonged exposure workshop with and without consultation']","[""patients' PTSD symptoms"", 'provider attitudes (self-efficacy in delivering PE, expectations for patient improvement, and beliefs about PE), use of PE and PE components, and clinical outcomes of patients with PTSD (using the Clinician-Administered PTSD Scale (CAPS-5', 'PTSD severity', 'self-efficacy']",[],"[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.106804,"RESULTS
Extended condition providers reported greater improvements in self-efficacy,","[{'ForeName': 'Edna B', 'Initials': 'EB', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA. foa@pennmedicine.upenn.edu.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Health Care System, Menlo Park, CA, USA.'}, {'ForeName': 'Lily A', 'Initials': 'LA', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Yinyin', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenfield', 'Affiliation': 'Department of Psychology, Southern Methodist University, Dallas, TX, USA.'}, {'ForeName': 'Laurie J', 'Initials': 'LJ', 'LastName': 'Zandberg', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Ealey', 'Affiliation': 'Blanchfield Army Community Hospital, Fort Campbell, KY, USA.'}, {'ForeName': 'Brenda S', 'Initials': 'BS', 'LastName': 'Hanson', 'Affiliation': 'William Beaumont Army Medical Center, Fort Bliss, TX, USA.'}, {'ForeName': 'Lora Rose', 'Initials': 'LR', 'LastName': 'Hunter', 'Affiliation': 'Blanchfield Army Community Hospital, Fort Campbell, KY, USA.'}, {'ForeName': 'Ivett J', 'Initials': 'IJ', 'LastName': 'Lillard', 'Affiliation': 'Blanchfield Army Community Hospital, Fort Campbell, KY, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Patterson', 'Affiliation': 'Blanchfield Army Community Hospital, Fort Campbell, KY, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosado', 'Affiliation': 'William Beaumont Army Medical Center, Fort Bliss, TX, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Scott', 'Affiliation': 'Blanchfield Army Community Hospital, Fort Campbell, KY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Weber', 'Affiliation': 'Evans Army Community Hospital, Fort Carson, CO, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Wise', 'Affiliation': 'Blanchfield Army Community Hospital, Fort Campbell, KY, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Zamora', 'Affiliation': 'William Beaumont Army Medical Center, Fort Bliss, TX, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Implementation science : IS,['10.1186/s13012-020-01014-x']
2470,32735216,Perceived Effectiveness and Motivations for the Use of Web-Based Mental Health Programs: Qualitative Study.,"BACKGROUND
The prevalence of depression is high and has been stable despite increased treatment, research, and dissemination. People encounter barriers to seeking traditional mental health services, which could be mitigated by using web-based prevention methods.
OBJECTIVE
This study aims to understand what people at high risk for depression perceive as effective aspects of web-based mental health programs and what motivates people at high risk for depression to use web-based mental health programs.
METHODS
We conducted an inductive content analysis using telephone interview data from 77 participants at high risk for depression who were recruited from 2 randomized controlled trials (RCTs). Participants from the first RCT were working men who had been randomly assigned to 1 of the following 3 groups: control group, who had access to general depression information from a website called BroMatters; intervention group 1, who had access to the BroMatters website along with the associated BroHealth web-based mental health program; and intervention group 2, who had access to the BroMatters website, the BroHealth web-based mental health program, and telephone sessions with a life coach. Participants from the second RCT were men and women who had been assigned to the intervention group, who received access to the HardHat web-based mental health program, or the control group, who only received access to the HardHat web-based mental health program following completion of the RCT. Participants for this inductive content analysis study were recruited from the intervention groups in both RCTs. Two groups of participants (n=41 and n=20) were recruited from the BroHealth RCT, and a third group comprised 16 participants that were recruited from the HardHat RCT.
RESULTS
We generated four categories regarding the perceived effectiveness of web-based programs and five categories related to what motivates the use of web-based programs. Participants identified awareness, program medium and functionality, program content, and coaches as categories related to the effectiveness of the programs. Categories of motivators to use web-based programs included providing reminders or incentives, promotion of the programs, providing appropriate medium and functionality, appropriate content, and perceived need. The final category related to motivators reflects perceptions of participants who were either unsure about what motivates them or believed that there is no way to motivate use.
CONCLUSIONS
Conflicting evidence was obtained regarding the perceived effectiveness of aspects of the content and functionality of web-based programs. In general, web-based mental health programs were perceived to help increase mental health awareness, especially when it includes live access to a coach. However, the results also revealed that it is difficult to motivate people to begin using web-based mental health programs. Strategies that may motivate the use of such programs include perceived personal need, effective promotion, providing incentives and reminders, and improving functionality.",2020,"In general, web-based mental health programs were perceived to help increase mental health awareness, especially when it includes live access to a coach.","['Participants from the first RCT were working men who had been randomly assigned to 1 of the following 3 groups', 'Two groups of participants (n=41 and n=20) were recruited from the BroHealth RCT, and a third group comprised 16 participants that were recruited from the HardHat RCT', '77 participants at high risk for depression who were recruited from 2 randomized controlled trials (RCTs', 'Participants from the second RCT were men and women who had been assigned to the intervention group, who received']","['control group, who had access to general depression information from a website called BroMatters; intervention group 1, who had access to the BroMatters website along with the associated BroHealth web-based mental health program; and intervention group 2, who had access to the BroMatters website, the BroHealth web-based mental health program, and telephone sessions with a life coach', 'access to the HardHat web-based mental health program, or the control group, who only received access to the HardHat web-based mental health program following completion of the RCT']",[],"[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",[],77.0,0.075457,"In general, web-based mental health programs were perceived to help increase mental health awareness, especially when it includes live access to a coach.","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Eccles', 'Affiliation': 'Work & Mental Health Research Unit, The Institute of Mental Health Research, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Nannarone', 'Affiliation': 'Work & Mental Health Research Unit, The Institute of Mental Health Research, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Lashewicz', 'Affiliation': 'Department of Community Health Sciences,, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Attridge', 'Affiliation': 'Attridge Consulting, Inc, Minneapolis, MN, United States.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Marchand', 'Affiliation': 'School of Industrial Relations, University of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Aiken', 'Affiliation': 'Office of Research and Innovation, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Kendall', 'Initials': 'K', 'LastName': 'Ho', 'Affiliation': 'Department of Emergency Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Jianli', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Work & Mental Health Research Unit, The Institute of Mental Health Research, University of Ottawa, Ottawa, ON, Canada.'}]",Journal of medical Internet research,['10.2196/16961']
2471,32737183,Effects of Inactivation of the Periaqueductal Gray on Song Production in Testosterone-Treated Male Canaries ( Serinus canaria ).,"Male canaries ( Serinus canaria ) display seasonal changes in the motivation to sing which have been found to be dependent on the action of testosterone (T). During the breeding season when T is high, males sing at a higher rate compared with males with low T. The effect of T on song rate is known to be mediated by the medial preoptic nucleus (POM); however, it is unclear how T signaling in POM impacts song production. One potential mechanism is via modulation of dopaminergic input into song control nuclei by the periaqueductal gray (PAG). In order to test the role of PAG in T-mediated song production, we treated male canaries with peripheral T implants and implanted a guide cannula targeting the PAG. Through this guide cannula, we transiently inactivated PAG with injections of the GABA A agonist, muscimol. Each bird received multiple infusions of both muscimol and saline with a 48-h washout period between treatments. The order of injection type was randomized and counterbalanced between individuals. Muscimol infusion into the PAG, but not nearby regions, increased the latency to sing post-injection. These results support the hypothesis that PAG is involved in the production of song, potentially mediating the motivation to sing or alternatively interfering with the pre-motor activity of nucleus RA. Other song features were however not affected.",2020,"Muscimol infusion into the PAG, but not nearby regions, increased the latency to sing post-injection.",['Testosterone-Treated Male Canaries ( Serinus canaria '],['muscimol and saline'],[],"[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0006824', 'cui_str': 'Genus Serinus'}, {'cui': 'C1095844', 'cui_str': 'Serinus canaria'}]","[{'cui': 'C0026818', 'cui_str': 'Muscimol'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]",[],,0.0304729,"Muscimol infusion into the PAG, but not nearby regions, increased the latency to sing post-injection.","[{'ForeName': 'Chelsea M', 'Initials': 'CM', 'LastName': 'Haakenson', 'Affiliation': 'Program in Neuroscience and Cognitive Science, Department of Psychology, University of Maryland, College Park, MD 20742, chaakens@umd.edu.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Balthazart', 'Affiliation': 'Laboratory of Behavioral Neuroendocrinology, GIGA Neurosciences, University of Liege, 15 Avenue Hippocrate, 4000, Liege, Belgium.'}, {'ForeName': 'Gregory F', 'Initials': 'GF', 'LastName': 'Ball', 'Affiliation': 'Program in Neuroscience and Cognitive Science, Department of Psychology, University of Maryland, College Park, MD 20742.'}]",eNeuro,['10.1523/ENEURO.0048-20.2020']
2472,32747036,Efficacy and safety of a low-dose continuous combined hormone replacement therapy with 0.5 mg 17β-estradiol and 2.5 mg dydrogesterone in subgroups of postmenopausal women with vasomotor symptoms.,"OBJECTIVES
Various combinations of estrogens and progestogens are available for menopausal hormone therapy that differ in their efficacy and safety profile. We evaluated the efficacy and long-term safety of low-dose estradiol (0.5 mg) / dydrogesterone (2.5 mg) in subgroups of postmenopausal women with vasomotor symptoms.
ANALYSIS
Efficacy analysis was performed on data from 2 previously published studies for subgroups defined by age, duration of menopause, and body mass index at baseline. The primary efficacy variable was the number of moderate to severe hot flushes from baseline to week 13. Long-term safety was evaluated in relation to age and duration of menopause. Safety variables included adverse events to week 52 and change from baseline to endpoint in laboratory and vital sign values.
RESULTS
The treatment difference seen in the overall population in favour of low-dose estradiol/dydrogesterone was also observed in the subgroups of patients aged 45 to < 55 years (p < 0.01) and ≥55 years (p < 0.05), with menopause duration of >12 months to <60 months (p < 0.05) and ≥ 60 months (p < 0.005), and with a BMI at baseline of <25 kg/m 2 (p < 0.05) and 25 to <30 kg/m 2 (p < 0.01). Low-dose estradilol/dydrogesterone was well tolerated across the different subgroups. The incidence of breast-related adverse events was very low. No breast malignancy was reported. Only one adverse endometrial outcome of simple hyperplasia was observed.
CONCLUSION
The results of our analyses confirmed the consistent treatment effect on vasomotor symptoms and the favourable safety profile of 0.5 mg 17β estradiol and 2.5 mg dydrogesterone in different patient subgroups.",2020,"The treatment difference seen in the overall population in favour of low-dose estradiol/dydrogesterone was also observed in the subgroups of patients aged 45 to < 55 years (p < 0.01) and ≥55 years (p < 0.05), with menopause duration of >12 months to <60 months (p < 0.05) and ≥ 60 months (p < 0.005), and with a BMI at baseline of <25 kg/m 2 (p < 0.05) and 25 to <30 kg/m 2 (p < 0.01).",['subgroups of postmenopausal women with vasomotor symptoms'],"['low-dose estradiol', 'estrogens and progestogens', 'low-dose continuous combined hormone replacement therapy with 0.5 mg 17β-estradiol and 2.5 mg dydrogesterone', 'dydrogesterone', 'Low-dose estradilol/dydrogesterone']","['laboratory and vital sign values', 'number of moderate to severe hot flushes', 'incidence of breast-related adverse events', 'Efficacy and safety', 'adverse endometrial outcome of simple hyperplasia', 'adverse events', 'vasomotor symptoms']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0013340', 'cui_str': 'Dydrogesterone'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0304071,"The treatment difference seen in the overall population in favour of low-dose estradiol/dydrogesterone was also observed in the subgroups of patients aged 45 to < 55 years (p < 0.01) and ≥55 years (p < 0.05), with menopause duration of >12 months to <60 months (p < 0.05) and ≥ 60 months (p < 0.005), and with a BMI at baseline of <25 kg/m 2 (p < 0.05) and 25 to <30 kg/m 2 (p < 0.01).","[{'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Tsiligiannis', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, Royal Brompton and Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK.'}, {'ForeName': 'Bettina C', 'Initials': 'BC', 'LastName': 'Wick-Urban', 'Affiliation': 'Meda Pharma GmbH & Co. KG (A Mylan Company), Benz Street 1, 61350 Bad Homburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van der Stam', 'Affiliation': 'Mylan Healthcare BV, Krijgsman, 1186 DM Amstelveen NH, the Netherlands.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Stevenson', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, Royal Brompton and Harefield NHS Foundation Trust, Sydney Street, London SW3 6NP, UK. Electronic address: j.stevenson@imperial.ac.uk.'}]",Maturitas,['10.1016/j.maturitas.2020.05.002']
2473,32748463,EBUS-TBNA versus EUS-B-FNA for the evaluation of undiagnosed mediastinal lymphadenopathy: The TEAM randomized controlled trial.,"BACKGROUND
Endobronchial Ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a standard of care modality for the evaluation of mediastinal lymphadenopathy. Transesophageal Bronchoscopic Ultrasound-Guided Fine Needle Aspiration (EUS-B-FNA), wherein one introduces the EBUS bronchoscope through the esophageal route, is also a safe and efficacious diagnostic modality for sampling the mediastinal lymph nodes. The objective of this study was to compare the diagnostic yield and patient comfort with these two available approaches.
METHODS
We randomized subjects with predominant subcarinal or lower left paratracheal mediastinal lymph node enlargement to either EBUS-TBNA or EUS-B-FNA (50 to each group). Co-Primary objectives were the comparison of adequate and diagnostic aspirates between groups. Key secondary objectives were a comparison of Operator rated cough and Operator rated procedural comfort on Visual Analog scale (VAS), procedure duration and complications between the groups.
RESULTS
Baseline characteristics were comparable between the groups. The proportion of adequate (EBUS-TBNA 46/50; 92% and EUS-B-FNA 48/50;96%, P = 0.4) and diagnostic aspirates (EBUS-TBNA 38/50; 76% and EUS-B-FNA 36/50;74%, P = 0.4) were similar between the two groups. Operator rated cough was significantly less, and Operator rated patient comfort significantly higher with the EUS-B-FNA approach. Procedure duration was significantly shorter with EUS-B-FNA [18.1(14.4) minutes versus 16.4 (49.6) minutes, P < 0.001]. Minor complications occurred in one patient in the EBUS-TBNA group and none in the EUS-B-FNA group.
CONCLUSION
During the endosonographic evaluation for undiagnosed mediastinal lymphadenopathy located at predominantly the subcarinal or lower left paratracheal stations, EUS-B-FNA as compared with EBUS-TBNA provides greater patient comfort with a similar diagnostic yield.",2020,"Operator rated cough was significantly less, and Operator rated patient comfort significantly higher with the EUS-B-FNA approach.","['We randomized subjects with predominant subcarinal or lower left paratracheal mediastinal lymph node enlargement to eitherEBUS-TBNA or EUS-B-FNA (50 toeach group', 'undiagnosed mediastinal lymphadenopathy']","['Endobronchial Ultrasound-guided transbronchial needle aspiration (EBUS-TBNA', 'EBUS-TBNA vs EUS-B-FNA', 'Transesophageal Bronchoscopic Ultrasound-Guided Fine Needle Aspiration (EUS-B-FNA']","['Operator rated cough', 'Procedure duration', 'Minorcomplications', 'comparison of Operator rated cough and Operator rated procedural comfort on Visual Analogue scale (VAS), procedure duration, and complications between the groups']","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0442143', 'cui_str': 'Paratracheal'}, {'cui': 'C0588055', 'cui_str': 'Mediastinal lymph node group'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0520743', 'cui_str': 'Mediastinal lymphadenopathy'}, {'cui': 'C0522518', 'cui_str': 'Transesophageal approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0520743', 'cui_str': 'Mediastinal lymphadenopathy'}, {'cui': 'C0522518', 'cui_str': 'Transesophageal approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}]","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",,0.111372,"Operator rated cough was significantly less, and Operator rated patient comfort significantly higher with the EUS-B-FNA approach.","[{'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Madan', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Neha Kawatra', 'Initials': 'NK', 'LastName': 'Madan', 'Affiliation': 'Department of Pathology, VMMC and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Pavan', 'Initials': 'P', 'LastName': 'Tiwari', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Deepali', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Pathology, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Sudheer', 'Initials': 'S', 'LastName': 'Arava', 'Affiliation': 'Department of Pathology, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Hadda', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Pramod', 'Initials': 'P', 'LastName': 'Garg', 'Affiliation': 'Department of Gastroenterology, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Randeep', 'Initials': 'R', 'LastName': 'Guleria', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}]",The clinical respiratory journal,['10.1111/crj.13244']
2474,32755488,"Can We Eliminate Opioid Medications for Postoperative Pain Control? A Prospective, Surgeon-Blinded, Randomized Controlled Trial in Knee Arthroscopic Surgery.","BACKGROUND
Orthopaedic surgeons have a responsibility to develop responsible opioid practices. Growing evidence has helped define an optimal number of opioids to prescribe after surgical procedures, but little evidence-based guidance exists to support specific practice patterns to decrease opioid utilization.
HYPOTHESIS
After knee arthroscopic surgery with partial meniscectomy, patients who were provided a prescription for opioids and instructed to only fill the prescription if absolutely necessary for pain control would take fewer opioids than patients with opioids automatically included as part of a multimodal approach to pain control prescribed at discharge.
STUDY DESIGN
Randomized controlled trial; Level of evidence, 2.
METHODS
Patients undergoing arthroscopic partial meniscectomy were provided multimodal pain control with aspirin, acetaminophen, and naproxen and randomized to receive oxycodone as either included with their multimodal pain medications (group 1) or given an optional prescription to fill (group 2). Patients were contacted at time points up to 1 month after surgery to assess opioid utilization and medication side effects. The mean number of tablets utilized was the primary outcome measure, with a 50% reduction defined as a successful outcome.
RESULTS
A total of 105 patients were initially enrolled, and 95 (91%; 48 in group 1 and 47 in group 2) successfully completed the study. There was no significant reduction in the number of tablets utilized between groups 1 and 2 (3.5 vs 4.5, respectively; P = .45), days that opioids were required (2.2 vs 3.2, respectively; P = .20), or postoperative pain at any time point. The group with the option to fill their prescription had significantly fewer unused tablets remaining than the group with opioids included as part of the multimodal pain control regimen (75% of potentially prescribed tablets vs 82% of prescribed tablets; P < .001). Overall, 37% of patients did not require any opioids after surgery, and 86% used ≤8 tablets.
CONCLUSION
Patients required a minimal number of opioids after knee arthroscopic surgery with partial meniscectomy. There was no difference in the number of tablets utilized whether the opioid prescription was included in a multimodal pain control regimen or patients were given an option to fill the prescription. Offering optional opioid prescriptions in the setting of a multimodal approach to pain control can significantly reduce the number of unused opioids circulating in the community.
REGISTRATION
NCT03876743 (ClinicalTrials.gov identifier).",2020,There was no difference in the number of tablets utilized whether the opioid prescription was included in a multimodal pain control regimen or patients were given an option to fill the prescription.,"['Patients undergoing arthroscopic partial meniscectomy were provided multimodal pain control with', 'After knee arthroscopic surgery with partial meniscectomy, patients who were provided a prescription for opioids and instructed to only fill the prescription if absolutely necessary for pain control would take fewer opioids than patients with opioids automatically included as part of a multimodal approach to pain control prescribed at discharge', 'A total of 105 patients were initially enrolled, and 95 (91%; 48 in group 1 and 47 in group 2) successfully completed the study', 'Patients required a minimal number of opioids after knee arthroscopic surgery with partial meniscectomy', 'Knee Arthroscopic Surgery']","['aspirin, acetaminophen, and naproxen', 'oxycodone as either included with their multimodal pain medications (group 1) or given an optional prescription to fill']","['multimodal pain control regimen', 'number of tablets utilized', 'postoperative pain', 'successful outcome', 'opioid utilization and medication side effects', 'mean number of tablets utilized']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C4082765', 'cui_str': 'Arthroscopic knee operation'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",105.0,0.268241,There was no difference in the number of tablets utilized whether the opioid prescription was included in a multimodal pain control regimen or patients were given an option to fill the prescription.,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hartwell', 'Affiliation': 'Department of Orthopaedic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Selley', 'Affiliation': 'Department of Orthopaedic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Terry', 'Affiliation': 'Department of Orthopaedic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Vehniah K', 'Initials': 'VK', 'LastName': 'Tjong', 'Affiliation': 'Department of Orthopaedic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}]",The American journal of sports medicine,['10.1177/0363546520941861']
2475,32758299,EFFECT: a randomized phase II study of efficacy and impact on function of two doses of nab-paclitaxel as first-line treatment in older women with advanced breast cancer.,"BACKGROUND
Limited data are available regarding the use of nab-paclitaxel in older patients with breast cancer. A weekly schedule is recommended, but there is a paucity of evidence regarding the optimal dose. We evaluated the efficacy of two different doses of weekly nab-paclitaxel, with a specific focus on their corresponding impact on patient function, in order to address the lack of data specifically relating to the older population.
METHODS
EFFECT is an open-label, phase II trial wherein 160 women with advanced breast cancer aged ≥ 65 years were enrolled from 15 institutions within Italy. Patients were randomly assigned 1:1 to receive nab-paclitaxel 100 mg/m 2 (arm A) or 125 mg/m 2 (arm B) on days 1, 8, and 15 on a 28-day cycle, as first-line treatment for advanced disease. The primary endpoint was event-free survival (EFS), wherein an event was defined as disease progression (PD), functional decline (FD), or death. In each arm, the null hypothesis that the median EFS would be ≤ 7 months was tested against a one-sided alternative according to the Brookmeyer Crowley test. Secondary endpoints included objective response rate (ORR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS), and safety.
RESULTS
After a median follow-up of 32.6 months, 140 events were observed in 158 evaluable patients. Median EFS was 8.2 months (90% CI, 5.9-8.9; p = 0.188) in arm A vs 8.3 months (90% CI, 6.2-9.7, p = 0.078) in arm B. Progression-free survival, overall survival, and response rates were similar in both groups. A higher percentage of dose reductions and discontinuations due to adverse events (AEs) was noted in arm B. The most frequently reported non-haematological AEs were fatigue (grade [G] 2-3 toxicity occurrence in arm A vs B, 43% and 51%, respectively) and peripheral neuropathy (G2-3 arm A vs B, 19% and 38%, respectively).
CONCLUSION
Pre-specified outcomes were similar in both treatment arms. However, 100 mg/m 2 was significantly better tolerated with fewer neurotoxicity-related events, representing a more feasible dose to be recommended for older patients with advanced disease.
TRIAL REGISTRATION
EudraCT, 2012-002707-18 . Registered on June 4, 2012. NIH ClinicalTrials.gov, NCT02783222 . Retrospectively registered on May 26, 2016.",2020,A higher percentage of dose reductions and discontinuations due to adverse events (AEs) was noted in arm B.,"['older patients with breast cancer', 'older women with advanced breast cancer', '158 evaluable patients', '65\u2009years were enrolled from 15 institutions within Italy', 'older patients with advanced disease', '160 women with advanced breast cancer aged ≥']","['EFFECT', 'weekly nab-paclitaxel', 'nab-paclitaxel 100\u2009mg/m 2 (arm A) or 125', 'nab-paclitaxel']","['peripheral neuropathy', 'Median EFS', 'arm B. Progression-free survival, overall survival, and response rates', 'objective response rate (ORR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS), and safety', 'event-free survival (EFS), wherein an event was defined as disease progression (PD), functional decline (FD), or death', 'toxicity occurrence']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",160.0,0.185607,A higher percentage of dose reductions and discontinuations due to adverse events (AEs) was noted in arm B.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Biganzoli', 'Affiliation': '""Sandro Pitigliani"" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy. laura.biganzoli@uslcentro.toscana.it.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Department of Medical Oncology, Perrino Hospital, ASL Brindisi, Brindisi, Italy.'}, {'ForeName': 'Rossana', 'Initials': 'R', 'LastName': 'Berardi', 'Affiliation': 'Department of Medical Oncology, Ospedali Riuniti di Ancona, Università Politecnica delle Marche, Ancona, Italy.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Pedersini', 'Affiliation': 'Breast Oncology Unit, Hospital Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'McCartney', 'Affiliation': '""Sandro Pitigliani"" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy.'}, {'ForeName': 'Alessandro Marco', 'Initials': 'AM', 'LastName': 'Minisini', 'Affiliation': 'Department of Oncology, Azienda Ospedaliero Universitaria Integrata di Udine, Udine, Italy.'}, {'ForeName': 'Elena Rota', 'Initials': 'ER', 'LastName': 'Caremoli', 'Affiliation': 'Cancer Centre, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Spazzapan', 'Affiliation': 'Unit of Medical Oncology and Cancer Prevention, IRCCS CRO di Aviano, National Cancer Institute, Aviano, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Magnolfi', 'Affiliation': 'Department of Medical Oncology, Hospital Civile SS Trinità di Sora, Frosinone, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Brunello', 'Affiliation': 'Department of Medical Oncology, Veneto Institute of Oncology IOV Padova, Padua, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Risi', 'Affiliation': '""Sandro Pitigliani"" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Palumbo', 'Affiliation': 'Department of Medical Oncology, IRCCS ICS Maugeri, Pavia, Italy.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Leo', 'Affiliation': 'Department of Medical Oncology, Vito Fazzi Hospital, Lecce, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'Division of Medical Senology, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Donati', 'Affiliation': 'Department of Oncology, Versilia Hospital (Camaiore-Lu), Viareggio, Italy.'}, {'ForeName': 'Sabino', 'Initials': 'S', 'LastName': 'De Placido', 'Affiliation': 'Department of Endocrinology and Molecular and Clinical Oncology, AOU Federico II, Naples, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Orlando', 'Affiliation': 'Department of Medical Oncology, Perrino Hospital, ASL Brindisi, Brindisi, Italy.'}, {'ForeName': 'Mirco', 'Initials': 'M', 'LastName': 'Pistelli', 'Affiliation': 'Department of Medical Oncology, Ospedali Riuniti di Ancona, Università Politecnica delle Marche, Ancona, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Parolin', 'Affiliation': 'Department of Medical Oncology, Azienda Ospedaliera Universitaria Integrata, Verona, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mislang', 'Affiliation': '""Sandro Pitigliani"" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Becheri', 'Affiliation': 'Geriatric Medicine Unit, AUSL Toscana Centro, Prato, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Puglisi', 'Affiliation': 'Department of Oncology, Azienda Ospedaliero Universitaria Integrata di Udine, Udine, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Sanna', 'Affiliation': '""Sandro Pitigliani"" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Zafarana', 'Affiliation': '""Sandro Pitigliani"" Department of Medical Oncology, Hospital of Prato, ASL Toscana Centro, Prato, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'Clinical Trials Centre, AOU University Hospital Careggi, Florence, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mottino', 'Affiliation': 'Geriatric Medicine Unit, AUSL Toscana Centro, Prato, Italy.'}]",Breast cancer research : BCR,['10.1186/s13058-020-01319-1']
2476,32763106,Comment on: Bariatric surgery in the elderly: a randomized prospective study comparing safety of sleeve gastrectomy and Roux-en-Y gastric bypass (BASE Trial).,,2020,,['elderly'],"['sleeve gastrectomy and Roux-en-Y gastric bypass', 'Bariatric surgery']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]",[],,0.0107772,,"[{'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Lo Menzo', 'Affiliation': 'The Bariatric And Metabolic Institute, Cleveland Clinic Florida, Weston, Florida.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.06.048']
2477,32737973,Multimodal Balance Training Supported by Rhythmic Auditory Stimuli in Parkinson Disease: Effects in Freezers and Nonfreezers.,"OBJECTIVE
To fulfill the potential of nonpharmacological interventions for people with Parkinson disease (PD), individually tailored treatment is needed. Multimodal balance training supported by rhythmic auditory stimuli (RAS) can improve balance and gait in people with PD. The purpose of this study was to determine whether both freezers and nonfreezers benefit.
METHODS
A secondary analysis was conducted on a large randomized controlled trial that included 154 patients with PD (Hoehn & Yahr Stages 1-3 while ON-medication) who were assigned randomly to 3 groups: (1) multimodal balance training with RAS delivered by a metronome (RAS-supported multimodal balance training); (2) regular multimodal balance training without rhythmic auditory cues; and (3) a control intervention (involving an educational program). Training was performed for 5 weeks, twice per week. The primary outcome was the Mini-BESTest score directly after the training period. Assessments were performed by a single, masked assessor at baseline, directly postintervention, and after 1-month and 6-month follow-up. Outcomes were analyzed in 1 analysis, and the results were presented separately for freezers and nonfreezers with a linear mixed model, adjusted for baseline Mini-BESTest scores, Unified Parkinson's Disease Rating Scale scores, and levodopa equivalent dose.
RESULTS
In both freezers and nonfreezers, both RAS-supported multimodal training and regular training significantly improved the Mini-BESTest scores compared with baseline scores and with the control group scores. The improvement was larger for RAS-supported training compared with regular training, for both freezers and nonfreezers. Only the RAS-supported training group retained the improvements compared with baseline measurements at 6-month follow-up, and this was true for both freezers and nonfreezers.
CONCLUSIONS
RAS-supported multimodal training is effective in improving balance performance in both freezers and nonfreezers.
IMPACT
Until this study, it was unknown whether both freezers and nonfreezers could benefit from multimodal balance training. With this information, clinicians who work with people with PD will be better able to apply personalized gait rehabilitation.
LAY SUMMARY
Adding rhythmic auditory stimuli (RAS) to balance training is beneficial for both freezers and nonfreezers, at least in persons with mild to moderate disease stages. This RAS-supported multimodal training has good potential for a wider clinical implementation with good long-term effects.",2020,"Only the RAS-supported training group retained the improvements compared with baseline measurements at 6-month follow-up, and this was true for both freezers and nonfreezers.
","['154 patients with PD (Hoehn & Yahr Stages 1-3 while ON-medication', 'Parkinson Disease', 'Parkinson disease (PD']","['multimodal balance training with rhythmic auditory stimuli delivered by a metronome (RAS-supported multimodal balance training), (2) regular multimodal balance training without rhythmic auditory cues, and (3) a control intervention (involving an educational program', 'Multimodal balance training', 'Multimodal Balance Training', 'RAS-supported multimodal training']","['Mini-BESTest scores', 'balance performance', 'Mini-BESTest score directly', ""baseline Mini-BESTest scores, Unified Parkinson's Disease Rating Scale scores, and levodopa equivalent dose"", 'balance and gait in PD']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]",154.0,0.0633119,"Only the RAS-supported training group retained the improvements compared with baseline measurements at 6-month follow-up, and this was true for both freezers and nonfreezers.
","[{'ForeName': 'Tamine T C', 'Initials': 'TTC', 'LastName': 'Capato', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, and Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center; Nijmegen, the Netherlands; and Movement Disorders Clinic, Department of Neurology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, and Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center.'}, {'ForeName': 'Jordache', 'Initials': 'J', 'LastName': 'Ramjith', 'Affiliation': 'Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, University of São Paulo.'}, {'ForeName': 'Jorik', 'Initials': 'J', 'LastName': 'Nonnekes', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, and Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center; and Department of Rehabilitation, Sint Maartenskliniek, Nijmegen, the Netherlands.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, and Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center.'}]",Physical therapy,['10.1093/ptj/pzaa146']
2478,32738130,"Influence of concurrent capecitabine based chemoradiotherapy with bevacizumab on the survival rate, late toxicity and health-related quality of life in locally advanced rectal cancer: a prospective phase II CRAB trial.","Background Few studies reported early results on efficacy, toxicity of combined modality treatment for locally advanced rectal cancer (LARC) by adding bevacizumab to preoperative chemoradiotherapy, but long-term data on survival, and late complications are lacking. Further, none of the studies reported on the assessment of quality of life (QOL). Patients and methods After more than 5 years of follow-up, we updated the results of our previous phase II trial in 61 patients with LARC treated with neoadjuvant capecitabine, radiotherapy and bevacizumab (CRAB study) before surgery and adjuvant chemotherapy. Secondary endpoints of updated analysis were local control (LC), disease free (DFS) and overall survival (OS), late toxicity and longitudinal health related QOL (before starting the treatment and one year after the treatment) with questionnaire EORTC QLQ-C30 and EORTC QLQ-CR38. Results Median follow-up was 67 months. During the follow-up period, 16 patients (26.7%) died. The 5-year OS, DFS and LC rate were 72.2%, 70% and 92.4%. Patients with pathological positive nodes or pathological T3-4 tumors had significantly worse survival than patients with pathological negative nodes or T0-2 tumors. Nine patients (14.8%) developed grade 33 late complications of combined modality treatment, first event 12 months and last 87 months after operation (median time 48 months). Based on EORTC QLQ-C30 scores one year after treatment there were no significant changes in global QOL and three symptoms (pain, insomnia and diarrhea), but physical and social functioning significantly decreased. Based on QLQ-CR38 scores body image scores significantly increase, problems with weight loss significantly decrease, but sexual dysfunction in men and chemotherapy side effects significantly increase. Conclusions Patients with LARC and high risk factors, such as positive pathological lymph nodes and high pathological T stage, deserve more aggressive treatment in the light of improving long-term survival results. Patients after multimodality treatment should be given greater attention to the regulation of individual aspects of quality of life and the occurrence of late side effects.",2020,"Based on EORTC QLQ-C30 scores one year after treatment there were no significant changes in global QOL and three symptoms (pain, insomnia and diarrhea), but physical and social functioning significantly decreased.","['61 patients with LARC treated with', 'locally advanced rectal cancer (LARC', 'locally advanced rectal cancer', 'Patients with pathological positive nodes or pathological T3-4 tumors']","['neoadjuvant capecitabine, radiotherapy and bevacizumab (CRAB study) before surgery and adjuvant chemotherapy', 'capecitabine based chemoradiotherapy with bevacizumab', 'bevacizumab']","['5-year OS, DFS and LC rate', 'grade 33 late complications', 'local control (LC), disease free (DFS) and overall survival (OS), late toxicity and longitudinal health related QOL', 'questionnaire EORTC QLQ-C30 and EORTC QLQ-CR38', 'survival', 'physical and social functioning', 'quality of life (QOL', 'efficacy, toxicity', 'QLQ-CR38 scores body image scores', 'sexual dysfunction', 'global QOL and three symptoms (pain, insomnia and diarrhea', 'survival rate, late toxicity and health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0010260', 'cui_str': 'Infraorder Brachyura'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",61.0,0.0636662,"Based on EORTC QLQ-C30 scores one year after treatment there were no significant changes in global QOL and three symptoms (pain, insomnia and diarrhea), but physical and social functioning significantly decreased.","[{'ForeName': 'Vaneja', 'Initials': 'V', 'LastName': 'Velenik', 'Affiliation': 'Division of Radiotherapy, Institute of Oncology, Ljubljana, Slovenia.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Zadnik', 'Affiliation': 'Division of Epidemiology, Institute of Oncology, Ljubljana, Slovenia.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Omejc', 'Affiliation': 'Division of Surgery, University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Grosek', 'Affiliation': 'Division of Surgery, University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Mojca', 'Initials': 'M', 'LastName': 'Tuta', 'Affiliation': 'Division of Radiology, Institute of Oncology, Ljubljana, Slovenia.'}]",Radiology and oncology,['10.2478/raon-2020-0043']
2479,32744134,A Simple Goal Elicitation Tool Improves Shared Decision Making in Outpatient Orthopedic Surgery: A Randomized Controlled Trial.,"Introduction . Shared decision making involves educating the patient, eliciting their goals, and collaborating on a decision for treatment. Goal elicitation is challenging for physicians as previous research has shown that patients do not bring up their goals on their own. Failure to properly elicit patient goals leads to increased patient misconceptions and decisional conflict. We performed a randomized controlled trial to test the efficacy of a simple goal elicitation tool in improving patient involvement in decision making. Methods . We conducted a randomized, single-blind study of new patients presenting to a single, outpatient surgical center. Prior to their consultation, the intervention group received a demographics questionnaire and a goal elicitation worksheet. The control group received a demographics questionnaire only. After the consultation, both groups were asked to complete the Perceived Involvement in Care Scale (PICS) survey. We compared the mean PICS scores for the intervention and control groups using a nonparametric Mann-Whitney Wilcoxon test. Secondary analysis included a qualitative content analysis of the patient goals. Results . Our final cohort consisted of 96 patients (46 intervention, 50 control). Both groups were similar in terms of demographic composition. The intervention group had a significantly higher mean (SD) PICS score compared to the control group (9.04 [2.15] v. 7.54 [2.27], P < 0.01). Thirty-nine percent of patient goals were focused on receiving a diagnosis or treatment, while 21% of patients wanted to receive education regarding their illness or their treatment options. Discussion . A single-step goal elicitation tool was effective in improving patient-perceived involvement in their care. This tool can be efficiently implemented in both academic and nonacademic settings.",2020,"The intervention group had a significantly higher mean (SD) PICS score compared to the control group (9.04 [2.15] v. 7.54 [2.27], P < 0.01).","['96 patients (46 intervention, 50 control', 'Outpatient Orthopedic Surgery', 'new patients presenting to a single, outpatient surgical center']","['demographics questionnaire and a goal elicitation worksheet', 'demographics questionnaire only']","['mean PICS scores', 'qualitative content analysis of the patient goals', 'mean (SD) PICS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0730321', 'cui_str': 'Punctate inner choroidopathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",96.0,0.0671466,"The intervention group had a significantly higher mean (SD) PICS score compared to the control group (9.04 [2.15] v. 7.54 [2.27], P < 0.01).","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Mertz', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Romil F', 'Initials': 'RF', 'LastName': 'Shah', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Eppler', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Safran', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Palanca', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Serena S', 'Initials': 'SS', 'LastName': 'Hu', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gardner', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Derek F', 'Initials': 'DF', 'LastName': 'Amanatullah', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}, {'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Kamal', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, CA, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20943520']
2480,32741328,A Secondary Injury Prevention Program May Decrease Contralateral Anterior Cruciate Ligament Injuries in Female Athletes: 2-Year Injury Rates in the ACL-SPORTS Randomized Controlled Trial.,"OBJECTIVE
To determine whether the addition of perturbation training to a secondary injury prevention program reduces the rate of second anterior cruciate ligament (ACL) injury compared to the prevention program alone.
DESIGN
Single-blinded randomized controlled trial.
METHODS
Thirty-nine female athletes who intended to return to cutting/pivoting sports were enrolled 3 to 9 months after primary anterior cruciate ligament reconstruction (ACLR). Athletes were randomized to receive a training program of either progressive strengthening, agility, plyometrics, and prevention (SAPP) (n = 20) or SAPP plus perturbation training (n = 19); each had 10 sessions over 5 weeks. Occurrence and side of second ACL injury were recorded for 2 years after primary ACLR.
RESULTS
There were 9 second ACL injuries in the 2 years after ACLR. There was no statistically significant difference in rate or side of second ACL injury between the SAPP-plus-perturbation training and SAPP groups.
CONCLUSION
Adding perturbation training to a secondary ACL injury prevention program did not affect the rate of second ACL injury in female athletes. J Orthop Sports Phys Ther 2020;50(9):523-530. Epub 1 Aug 2020. doi:10.2519/jospt.2020.9407 .",2020,"There was no statistically significant difference in rate or side of second ACL injury between the SAPP+PERT and SAPP groups.
","['Thirty-nine female athletes who intended to return to cutting/pivoting sports were enrolled 3-9 months after primary ACLR', 'female athletes', 'Female Athletes']","['perturbation training to a secondary injury prevention program', 'progressive strengthening, agility, plyometric, and prevention (SAPP) or SAPP plus perturbation training (SAPP+PERT']","['Occurrence and side of second ACL injury', 'Contralateral Anterior Cruciate Ligament Injuries', 'rate or side of second ACL injury', 'rate of second ACL injuries', 'rate of second anterior cruciate ligament (ACL) injuries']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",39.0,0.0258922,"There was no statistically significant difference in rate or side of second ACL injury between the SAPP+PERT and SAPP groups.
","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Jacob J', 'Initials': 'JJ', 'LastName': 'Capin', 'Affiliation': ''}, {'ForeName': 'Amelia J H', 'Initials': 'AJH', 'LastName': 'Arundale', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarzycki', 'Affiliation': ''}, {'ForeName': 'Angela H', 'Initials': 'AH', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Snyder-Mackler', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2020.9407']
2481,32747522,Effect of fremanezumab on quality of life and productivity in patients with chronic migraine.,"OBJECTIVE
To evaluate fremanezumab quarterly or monthly vs placebo on health-related quality of life, health status, patients' global impression of change, and productivity in patients with chronic migraine (CM).
METHODS
HALO CM was a double-blind, placebo-controlled trial in patients with CM. Patients were randomized 1:1:1 to treatment with fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), fremanezumab monthly (225 mg at baseline, weeks 4 and 8), or placebo. This article assessed the effect of treatment with fremanezumab on health-related quality of life and productivity using the following prespecified assessments: the Migraine-Specific Quality of Life (MSQoL) questionnaire at baseline and weeks 4, 8, and 12; Patient Global Impression of Change (PGIC) questionnaire at weeks 4, 8, and 12; and EuroQoL 5-dimension, 5-response level (EQ-5D-5L) questionnaire and Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire at baseline and week 12.
RESULTS
The full analysis set included 1,121 patients: 375 patients with quarterly dosing, 375 with monthly dosing, and 371 with placebo. Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all, p < 0.05) to week 12. At week 12, fremanezumab also showed significant improvements in EQ-5D-5L visual analog scale ( p < 0.05) and PGIC scores ( p < 0.0001) as well as significant reductions from baseline in WPAI:GH scores ( p < 0.01) and presenteeism (impairment while working; p < 0.05) vs placebo.
CONCLUSIONS
Fremanezumab quarterly or monthly was associated with improvement over placebo in migraine-specific quality of life, overall health status, patients' global impression of change with treatment, and productivity in patients with CM.
CLINICALTRIALSGOV IDENTIFIER
NCT02621931.
CLASSIFICATION OF EVIDENCE
This study provides Class II evidence that in patients with CM, treatment with fremanezumab quarterly or monthly is associated with improvements in health-related quality of life and productivity.",2020,"Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all, p < 0.05) to week 12.","['patients with chronic migraine (CM', 'Patients With Chronic Migraine', '1121 patients: 375 patients with quarterly dosing, 375 with monthly dosing, and 371 with', 'patients with CM']","['fremanezumab', 'fremanezumab quarterly (675 mg at baseline, placebo', 'Fremanezumab', 'fremanezumab quarterly or monthly vs placebo', 'placebo']","[""health-related quality of life, health status, patients' global impression of change, and productivity"", 'Quality of Life and Productivity', 'health-related quality of life and productivity', 'migraine-specific quality of life, overall health status', 'EuroQoL 5-dimension, 5-response level (EQ-5D-5L) questionnaire and Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire', 'Migraine-Specific Quality of Life (MSQoL) questionnaire', 'PGIC scores', 'WPAI:GH scores', 'Patient Global Impression of Change (PGIC) questionnaire', 'EQ-5D-5L visual analog scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C4517854', 'cui_str': '675'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",1121.0,0.33054,"Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all, p < 0.05) to week 12.","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA. Richard.Lipton@einstein.yu.edu.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Sanjay K', 'Initials': 'SK', 'LastName': 'Gandhi', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Yeung', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Dawn C', 'Initials': 'DC', 'LastName': 'Buse', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}]",Neurology,['10.1212/WNL.0000000000010000']
2482,32750499,Improving episodic memory: Frontal-midline theta neurofeedback training increases source memory performance.,"Cognitive and neurofeedback training (NFT) studies have demonstrated that training-induced alterations of frontal-midline (FM) theta activity (4-8 Hz) transfer to cognitive control processes. Given that FM theta oscillations are assumed to provide top-down control for episodic memory retrieval, especially for source retrieval, that is, accurate recollection of contextual details of prior episodes, the present study investigated whether FM theta NFT transfers to memory control processes. It was assessed (1) whether FM theta NFT improves source retrieval and modulates its underlying EEG characteristics and (2) whether this transfer extends over two posttests. Over seven NFT sessions, the training group who trained individual FM theta activity showed greater FM theta increase than an active control group who trained randomly chosen frequency bands. The training group showed better source retrieval in a posttraining session performed 13 days after NFT and their performance increases from pre- to both posttraining sessions were predicted by NFT theta increases. Thus, training-induced enhancement of memory control processes seems to protect newly formed memories from proactive interference of previously learned information. EEG analyses revealed that during pretest both groups showed source memory specific theta activity at frontal and parietal sites. Surprisingly, training-induced improvements in source retrieval tended to be accompanied by less prestimulus FM theta activity, which was predicted by NFT theta change for the training but not the control group, suggesting a more efficient use of memory control processes after training. The present findings provide unique evidence for the enhancement of memory control processes by FM theta NFT.",2020,The training group showed better source retrieval in a posttraining session performed 13 days after NFT and their performance increases from pre- to both posttraining sessions were predicted by NFT theta increases.,[],"['FM theta NFT', 'Cognitive and neurofeedback training (NFT']","['FM theta increase', 'source retrieval', 'source memory specific theta activity']",[],"[{'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0178591,The training group showed better source retrieval in a posttraining session performed 13 days after NFT and their performance increases from pre- to both posttraining sessions were predicted by NFT theta increases.,"[{'ForeName': 'Kathrin C J', 'Initials': 'KCJ', 'LastName': 'Eschmann', 'Affiliation': 'Experimental Neuropsychology Unit, Department of Psychology, Saarland University, Saarbrücken, Germany; Cardiff University Brain Research Imaging Centre (CUBRIC), School of Psychology, Cardiff University, Cardiff, United Kingdom. Electronic address: eschmannk@cardiff.ac.uk.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Bader', 'Affiliation': 'Experimental Neuropsychology Unit, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Mecklinger', 'Affiliation': 'Experimental Neuropsychology Unit, Department of Psychology, Saarland University, Saarbrücken, Germany.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117219']
2483,32750571,Recurrent venous thromboembolism during anticoagulation with edoxaban or warfarin: A post hoc analysis of the Hokusai-VTE trial.,"INTRODUCTION
Venous thromboembolism (VTE) may recur during anticoagulation, but the actual rate is not well established. In a post hoc analysis of the Hokusai-VTE trial we evaluated the risk and determinants of recurrent VTE of patients during anticoagulation with heparin, edoxaban or warfarin.
MATERIALS AND METHODS
The Hokusai-VTE study showed that in VTE patients edoxaban was non-inferior to warfarin with significantly less bleeding. Treatment duration ranged from 3 to 12 months. The recurrent VTE during anticoagulation period was defined as the VTE which occurred from the date of the first to the last dose (+3 days) of study drug.
RESULTS
147 of 8240 patients (1.8%) had a recurrent VTE during anticoagulant treatment. Median duration of anticoagulation was 267 days. 80 (54%) patients recurred within the first 30 days, 39 of those during heparin lead-in. 23 of 147 patients died of pulmonary embolism (PE) during anticoagulation (case fatality rate 15.6%). 13 of those fatalities (57%) occurred during the first 30 days; 4 of those during heparin lead-in. The recurrence risk was numerically lower in patients assigned to edoxaban compared to those assigned to warfarin, particularly beyond 30 days. We observed a trend towards a higher proportion of men, high NT-proBNP levels and obesity at the time of diagnosis among patients with early recurrence and mortality in particular.
CONCLUSION
The risk of recurrent VTE and PE-related mortality during the time of anticoagulation is low but noteworthy. Further studies are warranted to sharpen the risk profile of VTE patients in order to improve treatment and reduce mortality.",2020,23 of 147 patients died of pulmonary embolism (PE) during anticoagulation (case fatality rate 15.6%).,"['23 of 147 patients died of pulmonary embolism (PE) during anticoagulation (case fatality rate 15.6', '147 of 8240 patients (1.8%) had a recurrent VTE during anticoagulant treatment']","['edoxaban', 'warfarin', 'heparin, edoxaban or warfarin', 'VTE patients edoxaban', 'edoxaban or warfarin']","['Median duration of anticoagulation', 'recurrence risk', 'Recurrent venous thromboembolism', 'bleeding']","[{'cui': 'C1306577', 'cui_str': 'O/E - dead'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0282250', 'cui_str': 'Case fatality rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",8240.0,0.0356656,23 of 147 patients died of pulmonary embolism (PE) during anticoagulation (case fatality rate 15.6%).,"[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Eichinger', 'Affiliation': 'Dept. of Medicine I, Medical University of Vienna, Austria. Electronic address: sabine.eichinger@meduniwien.ac.at.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Basking Ridge, NJ, United States of America.'}, {'ForeName': 'Minggao', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Basking Ridge, NJ, United States of America.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Grosso', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Basking Ridge, NJ, United States of America.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Kyrle', 'Affiliation': 'Dept. of Medicine I, Medical University of Vienna, Austria.'}]",Thrombosis research,['10.1016/j.thromres.2020.07.028']
2484,32755632,Training Community Therapists to Deliver an Individualized Mental Health Intervention for Autism Spectrum Disorder: Changes in Caregiver Outcomes and Mediating Role on Child Outcomes.,"OBJECTIVE
This study examines the impact of training therapists to deliver ""An Individualized Mental Health Intervention for autism spectrum disorder (ASD)"" (AIM HI) for children with autism spectrum disorder on caregiver outcomes and the mediating role of changes in caregiver outcomes on child outcomes.
METHOD
Data were drawn from a cluster randomized trial conducted in 29 publicly funded mental health programs randomized to receive AIM HI training or usual care. Therapists were recruited from enrolled programs and child/caregiver participants enrolled from therapists' caseloads. Participants included 202 caregivers of children 5 to 13 years of age with autism spectrum disorder. Caregiver strain and sense of competence were assessed at baseline and 6 month postbaseline. Child behaviors were assessed at baseline and 6, 12, and 18 months postbaseline. Therapist delivery of evidence-based intervention strategies were assessed between baseline and 6 months.
RESULTS
A significant training effect was observed for caregiver sense of competence, with AIM HI caregivers reporting significantly greater improvement relative to usual care. There was no significant training effect for caregiver strain. Observer-rated therapist delivery of evidence-based interventions strategies over 6 months mediated training effects for sense of competence at 6 months. Changes in sense of competence from baseline to 6 months was associated with reduced child challenging behaviors at 6 months and mediated child outcomes at 12 and 18 months.
CONCLUSION
Combined with research demonstrating effectiveness of therapist AIM HI training on child outcomes, this study provides further evidence of the positive impact of training community therapists in the AIM HI intervention.
CLINICAL TRIAL REGISTRATION INFORMATION
Effectiveness and Implementation of a Mental Health Intervention for ASD (AIM HI); https://clinicaltrials.gov/; NCT02416323.",2020,"Changes in sense of competence from baseline to 6 months was associated with reduced child challenging behaviors at 6 months and mediated child outcomes at 12 and 18 months.
","['children with autism spectrum disorder', 'Autism', 'Participants included 202 caregivers of children aged 5 to 13 with autism spectrum disorder', 'autism spectrum disorder (ASD', ""Therapists were recruited from enrolled programs and child/caregiver participants enrolled from therapists' caseloads"", 'Data were drawn from a cluster randomized trial conducted in 29 publicly-funded mental health programs']","['Mental Health Intervention', 'HI training or usual care', 'therapist AIM HI training', 'training therapists to deliver An Individualized Mental Health Intervention']","['Caregiver strain and sense of competence', 'Child behaviors', 'caregiver sense of competence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}]",202.0,0.180546,"Changes in sense of competence from baseline to 6 months was associated with reduced child challenging behaviors at 6 months and mediated child outcomes at 12 and 18 months.
","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Brookman-Frazee', 'Affiliation': ""Child and Adolescent Services Research Center, San Diego, California; University of California, San Diego; Rady Children's Hospital, San Diego, California.""}, {'ForeName': 'Colby', 'Initials': 'C', 'LastName': 'Chlebowski', 'Affiliation': 'Child and Adolescent Services Research Center, San Diego, California; University of California, San Diego. Electronic address: cchlebowski@health.ucsd.edu.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Villodas', 'Affiliation': 'Child and Adolescent Services Research Center, San Diego, California; San Diego State University, California.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Roesch', 'Affiliation': 'San Diego State University, California.'}, {'ForeName': 'Kassandra', 'Initials': 'K', 'LastName': 'Martinez', 'Affiliation': 'Child and Adolescent Services Research Center, San Diego, California; University of California, San Diego; San Diego State University, California.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.07.896']
2485,32761638,Increasing cardiovascular medication adherence: A medical research council complex mhealth intervention mixed-methods feasibility study to inform global practice.,"AIMS
To evaluate a mHealth intervention to increase medication adherence among Iranian coronary heart disease patients.
DESIGN
Quantitative-dominant mixed-methods study.
DATA SOURCE
Iranian coronary heart disease patients' responses and most recent clinical documents as well as responses from Iranian cardiac nurses who participated in this study.
METHODS
The study was conducted between September 2015-April 2016 drawing on the Medical Research Council's Framework. Phase one comprised of a patients' survey and focus groups with cardiac nurses. The automated short message service reminder was piloted in phase two. We recruited 78 patients and randomized to receive either 12-week daily reminders or usual care. The primary outcome was the effect on medication adherence; secondary outcomes were self-efficacy, ejection fraction, functional capacity, readmission rate and quality of life.
RESULTS
Feasibility was evidenced by high ownership of mobile phones and high interest in receiving reminders. Participants in the intervention group showed significantly higher medication adherence compared with the control group.
CONCLUSION
The mHealth intervention was well accepted and feasible with early evidence of effectiveness that needs to be confirmed in a fully powered future randomized clinical trial.",2020,"Participants in the intervention group showed significantly higher medication adherence compared with the control group.
","[""September 2015-April 2016 drawing on the Medical Research Council's Framework"", 'Iranian cardiac nurses who participated in this study', '78 patients', 'Iranian coronary heart disease patients']","['12-week daily reminders or usual care', 'mHealth intervention']","['medication adherence; secondary outcomes were self-efficacy, ejection fraction, functional capacity, readmission rate and quality of life', 'cardiovascular medication adherence', 'medication adherence']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C3887625', 'cui_str': 'Coronary care nurse'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0007220', 'cui_str': 'Cardiovascular agent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",78.0,0.0982752,"Participants in the intervention group showed significantly higher medication adherence compared with the control group.
","[{'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Khonsari', 'Affiliation': 'School of Health in Social Science, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Chandler', 'Affiliation': 'School of Health in Social Science, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Parker', 'Affiliation': 'Usher Institute, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Holloway', 'Affiliation': 'School of Health in Social Science, The University of Edinburgh, Edinburgh, UK.'}]",Journal of advanced nursing,['10.1111/jan.14465']
2486,32757999,Prospective Single-Blinded Randomized Controlled Trial Comparing Pericapsular Injection Versus Lumbar Plexus Peripheral Nerve Block for Hip Arthroscopy.,"BACKGROUND
Hip arthroscopy has become the standard for the operative treatment of symptomatic femoroacetabular impingement. Given the high levels of postoperative pain associated with hip arthroscopy, optimal analgesia is critical to ensure patient comfort and safety after discharge.
PURPOSE/HYPOTHESIS
Our purpose was to perform a single-blinded randomized controlled trial comparing the use of pericapsular injection versus lumbar plexus blockade for postoperative pain control after arthroscopic surgery on the hip. We hypothesized that pericapsular injection would provide equivalent pain relief to that of lumbar plexus blockade while minimizing adverse effects and alleviating the dependence on a qualified individual to administer.
STUDY DESIGN
Randomized controlled trial; Level of evidence, 1.
METHODS
A total of 64 consecutive patients undergoing hip arthroscopy were prospectively assessed over a 6-month period between 2017 and 2018. Patients were randomly allocated to 1 of 2 groups: 32 patients received a lumbar plexus blockade by a single anesthesiologist, while 32 patients received a pericapsular injection of 30 mL of ropivacaine and 12 mg of morphine. Postoperative pain in the postanesthesia care unit (PACU) as measured using the numeric rating scale, time to discharge, PACU morphine equivalents, and adverse effects were collected by PACU staff. Postoperative day 1 and 2 narcotic use was obtained through a telephone call with the patient on postoperative day 3.
RESULTS
We found no statistically significant difference in PACU pain scores at all time points, although there was a trend toward lower pain for patients receiving a pericapsular injection. PACU and short-term narcotic demand did not vary across the 2 arms. Time to discharge from the PACU did not differ. There were no major adverse events reported for either intervention.
CONCLUSION
Pericapsular injection provides equivalent analgesia when compared with lumbar plexus blockade. It is a safe intervention that allows for efficient postoperative analgesia for patients undergoing hip arthroscopy.
REGISTRATION
ClinicalTrials.gov ID: NCT03244631.",2020,"There were no major adverse events reported for either intervention.
","['patients undergoing hip arthroscopy', '64 consecutive patients undergoing hip arthroscopy were prospectively assessed over a 6-month period between 2017 and 2018', 'postoperative pain control after arthroscopic surgery on the hip', 'Hip Arthroscopy']","['pericapsular injection of 30 mL of ropivacaine and 12 mg of morphine', 'lumbar plexus blockade', 'pericapsular injection versus lumbar plexus blockade', 'Pericapsular Injection Versus Lumbar Plexus Peripheral Nerve Block', 'Pericapsular injection', 'pericapsular injection']","['numeric rating scale, time to discharge, PACU morphine equivalents, and adverse effects', 'Postoperative pain', 'lower pain', 'PACU pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186190', 'cui_str': 'Diagnostic arthroscopy of hip joint'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0750934', 'cui_str': 'Arthroscopy with surgical procedure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}]","[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205826', 'cui_str': 'Lumbar plexus structure'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",64.0,0.258223,"There were no major adverse events reported for either intervention.
","[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Scanaliato', 'Affiliation': 'William Beaumont Army Medical Center, El Paso, Texas, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Christensen', 'Affiliation': 'Naval Medical Center Pensacola, Pensacola, Florida, USA.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Polmear', 'Affiliation': 'William Beaumont Army Medical Center, El Paso, Texas, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Salfiti', 'Affiliation': 'Washington Orthopaedics and Sports Medicine, Washington, DC, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Gaspar', 'Affiliation': 'Reston Anesthesia Associates, Reston, Virginia, USA.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Wolff', 'Affiliation': 'Washington Orthopaedics and Sports Medicine, Washington, DC, USA.'}]",The American journal of sports medicine,['10.1177/0363546520943580']
2487,32759361,"Reducing Inpatient Hypoglycemia in the General Wards Using Real-time Continuous Glucose Monitoring: The Glucose Telemetry System, a Randomized Clinical Trial.","OBJECTIVE
Use of real-time continuous glucose monitoring (RT-CGM) systems in the inpatient setting is considered investigational. The objective of this study was to evaluate whether RT-CGM, using the glucose telemetry system (GTS), can prevent hypoglycemia in the general wards.
RESEARCH DESIGN AND METHODS
In a randomized clinical trial, insulin-treated patients with type 2 diabetes at high risk for hypoglycemia were recruited. Participants were randomized to RT-CGM/GTS or point-of-care (POC) blood glucose testing. The primary outcome was difference in inpatient hypoglycemia.
RESULTS
Seventy-two participants were included in this interim analysis, 36 in the RT-CGM/GTS group and 36 in the POC group. The RT-CGM/GTS group experienced fewer hypoglycemic events (<70 mg/dL) per patient (0.67 [95% CI 0.34-1.30] vs. 1.69 [1.11-2.58], P = 0.024), fewer clinically significant hypoglycemic events (<54 mg/dL) per patient (0.08 [0.03-0.26] vs. 0.75 [0.51-1.09], P = 0.003), and a lower percentage of time spent below range <70 mg/dL (0.40% [0.18-0.92%] vs. 1.88% [1.26-2.81%], P = 0.002) and <54 mg/dL (0.05% [0.01-0.43%] vs. 0.82% [0.47-1.43%], P = 0.017) compared with the POC group. No differences in nocturnal hypoglycemia, time in range 70-180 mg/dL, and time above range >180-250 mg/dL and >250 mg/dL were found between the groups. The RT-CGM/GTS group had no prolonged hypoglycemia compared with 0.20 episodes <54 mg/dL and 0.40 episodes <70 mg/dL per patient in the POC group.
CONCLUSIONS
RT-CGM/GTS can decrease hypoglycemia among hospitalized high-risk insulin-treated patients with type 2 diabetes.",2020,"The RT-CGM/GTS group experienced fewer hypoglycemic events (<70 mg/dL) per patient (0.67 [95% CI 0.34-1.30] vs. 1.69 [1.11-2.58], P = 0.024), fewer clinically significant hypoglycemic events (<54 mg/dL) per patient (0.08 [0.03-0.26] vs. 0.75 [0.51-1.09], P = 0.003), and a lower percentage of time spent below range <70 mg/dL (0.40% [0.18-0.92%] vs. 1.88% [1.26-2.81%], P = 0.002) and <54 mg/dL (0.05% [0.01-0.43%] vs. 0.82% [0.47-1.43%], P = 0.017) compared with the POC group.","['treated patients with type 2 diabetes at high risk for hypoglycemia were recruited', 'Seventy-two participants were included in this interim analysis, 36 in the RT-CGM/GTS group and 36 in the POC group']","['RT-CGM', 'RT-CGM/GTS or point-of-care (POC) blood glucose testing', 'insulin', 'RT-CGM/GTS', 'glucose telemetry system (GTS', 'real-time continuous glucose monitoring (RT-CGM']","['nocturnal hypoglycemia', 'hypoglycemia', 'inpatient hypoglycemia', 'prolonged hypoglycemia', 'Inpatient Hypoglycemia', 'hypoglycemic events']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039451', 'cui_str': 'Telemetry'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039451', 'cui_str': 'Telemetry'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0342315', 'cui_str': 'Nocturnal hypoglycemia'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",72.0,0.0730647,"The RT-CGM/GTS group experienced fewer hypoglycemic events (<70 mg/dL) per patient (0.67 [95% CI 0.34-1.30] vs. 1.69 [1.11-2.58], P = 0.024), fewer clinically significant hypoglycemic events (<54 mg/dL) per patient (0.08 [0.03-0.26] vs. 0.75 [0.51-1.09], P = 0.003), and a lower percentage of time spent below range <70 mg/dL (0.40% [0.18-0.92%] vs. 1.88% [1.26-2.81%], P = 0.002) and <54 mg/dL (0.05% [0.01-0.43%] vs. 0.82% [0.47-1.43%], P = 0.017) compared with the POC group.","[{'ForeName': 'Lakshmi G', 'Initials': 'LG', 'LastName': 'Singh', 'Affiliation': 'Division of Endocrinology, Baltimore Veterans Affairs Medical Center, Baltimore, MD.'}, {'ForeName': 'Medha', 'Initials': 'M', 'LastName': 'Satyarengga', 'Affiliation': 'Center for Diabetes and Endocrinology, University of Maryland Shore Regional Health, Easton, MD.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Marcano', 'Affiliation': 'Division of Endocrinology, Diabetes, and Nutrition, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Scott', 'Affiliation': 'Division of Endocrinology, Baltimore Veterans Affairs Medical Center, Baltimore, MD.'}, {'ForeName': 'Lillian F', 'Initials': 'LF', 'LastName': 'Pinault', 'Affiliation': 'Division of Endocrinology, Baltimore Veterans Affairs Medical Center, Baltimore, MD.'}, {'ForeName': 'Zhaoyong', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': 'Pharmaceutical Research Computing, Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Sorkin', 'Affiliation': 'Baltimore Veterans Affairs Medical Center Geriatric Research, Education, and Clinical Center, Baltimore, MD.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Division of Endocrinology, Metabolism, and Lipids, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Elias K', 'Initials': 'EK', 'LastName': 'Spanakis', 'Affiliation': 'Division of Endocrinology, Baltimore Veterans Affairs Medical Center, Baltimore, MD ispanakis@som.umaryland.edu.'}]",Diabetes care,['10.2337/dc20-0840']
2488,32767160,A Single Session of Heart Rate Variability Biofeedback Produced Greater Increases in Heart Rate Variability Than Autogenic Training.,"Heart rate variability biofeedback (HRV-BF) has been confirmed to increase heart rate variability (HRV) and cardiac outflows by baroreflex in healthy populations and clinical patients. Autogenic training (AT) is common used in the psychological intervention. This study integrates a single-session of HRV-BF and AT into a high-technology mobile application (app), and examines the effects on HRV indices, breathing rates, and subjective relaxation scores. Healthy college students were recruited and assigned to the single-session HRV-BF group or AT group. Participants in the HRV-BF group received HRV-BF combined with paced breathing training, which gradually stepped down their breathing rates from 12, to 8, to 6 breaths/per min; and received feedback of HRV indices from the app. Participants in the AT group received autogenic training and feedback of heart rate from the app. A chest belt Zephyr BioHarness was connected through Bluetooth to a Zenfone5 mobile phone, it collected the signals of interbeat intervals and breathing rates at pre-training, mid-training, and post-training stages. The Kubios HRV software was used to analyze HRV indices. The results reveal higher HRV indices and lower breathing rates during mid-training and post-training in the HRV-BF group compared to the AT group. There were higher high-frequency of HRV at post-training than pre-training in the AT group. Participants of both groups increased their subjective relaxation scores after training. The HRV-BF protocol increased cardiac outflows by baroreflex and decreased breathing rates, and the AT protocol increased high-frequency of HRV. These high-technology wearable devices combined with psychological interventions will apply to various populations in the future.",2020,The results reveal higher HRV indices and lower breathing rates during mid-training and post-training in the HRV-BF group compared to the AT group.,"['healthy populations and clinical patients', 'Healthy college students']","['HRV-BF combined with paced breathing training', 'autogenic training', 'Autogenic training (AT', 'Heart rate variability biofeedback (HRV-BF']","['subjective relaxation scores', 'cardiac outflows by baroreflex and decreased breathing rates', 'Heart Rate Variability', 'HRV indices and lower breathing rates', 'heart rate variability (HRV) and cardiac outflows by baroreflex', 'high-frequency of HRV', 'HRV indices, breathing rates, and subjective relaxation scores']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004361', 'cui_str': 'Autogenic therapy'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]",,0.0287486,The results reveal higher HRV indices and lower breathing rates during mid-training and post-training in the HRV-BF group compared to the AT group.,"[{'ForeName': 'I-Mei', 'Initials': 'IM', 'LastName': 'Lin', 'Affiliation': 'Department of Psychology, Kaohsiung Medical University, No 100, Shih-Chuan 1 st Rd, Kaohsiung, 80708, Taiwan. psyiml@kmu.edu.tw.'}, {'ForeName': 'San-Yu', 'Initials': 'SY', 'LastName': 'Wang', 'Affiliation': 'Department of Psychology, Kaohsiung Medical University, No 100, Shih-Chuan 1 st Rd, Kaohsiung, 80708, Taiwan.'}, {'ForeName': 'Sheng-Yu', 'Initials': 'SY', 'LastName': 'Fan', 'Affiliation': 'Institute of Gerontology, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Peper', 'Affiliation': 'Institute for Holistic Health Studies, San Francisco State University, San Francisco, CA, USA.'}, {'ForeName': 'Sui-Pi', 'Initials': 'SP', 'LastName': 'Chen', 'Affiliation': 'Geographic Information Systems Research Center, Feng Chia University, Taichung, Taiwan.'}, {'ForeName': 'Ching-Yu', 'Initials': 'CY', 'LastName': 'Huang', 'Affiliation': 'Industrial Technology Research Institute, Hsinchu, Taiwan.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-020-09483-y']
2489,32762632,"The Hip Suction Seal, Part II: The Effect of Rim Trimming, Chondrolabral Junction Separation, and Labral Repair/Refixation on Hip Distractive Stability.","BACKGROUND
The acetabular labrum contains free nerve endings, and an unstable labrum can result in increased femoral head movement during hip motion. This can be caused by chondrolabral junction (CLJ) separation, especially in association with pincer-type femoroacetabular impingement, and may contribute to hip pain.
HYPOTHESIS
Rim resection alone has no effect on suction seal biomechanics. Further, separation of the CLJ changes hip suction seal biomechanics when compared with those of the native state, whereas repair and refixation with suture anchors restore these biomechanical parameters.
STUDY DESIGN
Controlled laboratory study.
METHODS
A total of 12 fresh-frozen human cadaveric hips were used in this study. Hips were mounted in a saline bath on a dynamic tensile testing machine and were distracted at a rate of 0.5 mm/s from neutral position. A total of 3 parameters (force, displacement, and intra-articular pressure) were measured throughout testing. Before testing, hips were randomly allocated to 1 of 2 groups: 1 that included the CLJ separation (CLJ Cut group) and 1 that did not (CLJ Intact group). Hips were tested in the following states: (1) native, (2) rim trimming, (3) separated CLJ (CLJ Cut group only), and (4) labral repair/refixation. For each group a linear mixed-effects model was used to compare biomechanical parameters between states.
RESULTS
Rim trimming did not affect any suction seal parameters relative to those of the native state. In the CLJ Cut group, no significant difference in distance to break the suction seal was observed for any states compared with that of the native state. In the CLJ Intact group, the distance to break the suction seal was significantly shorter in the labral refixation state (1.8 mm) than the native state (5.6 mm; P = .002). The maximum distraction force (62.1 ± 54.1 N) and the peak negative pressure (-36.6 ± 24.2 kPa) of the labral repair/refixation state were significantly lower than those of the native state in both groups (93.4 ± 41.7 N, P = .01; -60.7 ± 20.4 kPa, P = .02).
CONCLUSION
Rim trimming did not change the biomechanical properties of the labral suction seal. Labral refixation resulted in a shorter distance to break the labral suction seal. This indicates that labral mobility is reduced by the labral refixation procedure, which could be beneficial in postoperative pain relief and labral healing.
CLINICAL RELEVANCE
The labral refixation reduced labral mobility, which could be beneficial for both pain relief and labral healing to the acetabulum after pincer-type femoroacetabular impingement resection.",2020,"In the CLJ Cut group, no significant difference in distance to break the suction seal was observed for any states compared with that of the native state.",['A total of 12 fresh-frozen human cadaveric hips'],"['CLJ (CLJ Cut group only), and (4) labral repair/refixation', 'CLJ separation (CLJ Cut group) and 1 that did not (CLJ Intact group', 'Rim Trimming, Chondrolabral Junction Separation, and Labral Repair/Refixation']","['maximum distraction force', 'labral repair/refixation state', 'distance to break the suction seal', 'suction seal parameters', 'pain relief and labral healing', 'peak negative pressure', 'labral refixation state', 'suction seal biomechanics']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}]","[{'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0185042', 'cui_str': 'Reattachment - action'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0556630', 'cui_str': 'Anal penetration using tongue'}, {'cui': 'C0441645', 'cui_str': 'Trimming - action'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0185042', 'cui_str': 'Reattachment - action'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",12.0,0.0360113,"In the CLJ Cut group, no significant difference in distance to break the suction seal was observed for any states compared with that of the native state.","[{'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Utsunomiya', 'Affiliation': 'Steadman Philippon Research Institute, Vail, Colorado, USA.'}, {'ForeName': 'Hunter W', 'Initials': 'HW', 'LastName': 'Storaci', 'Affiliation': 'Steadman Philippon Research Institute, Vail, Colorado, USA.'}, {'ForeName': 'Samuel I', 'Initials': 'SI', 'LastName': 'Rosenberg', 'Affiliation': 'Steadman Philippon Research Institute, Vail, Colorado, USA.'}, {'ForeName': 'Bryson R', 'Initials': 'BR', 'LastName': 'Kemler', 'Affiliation': 'Steadman Philippon Research Institute, Vail, Colorado, USA.'}, {'ForeName': 'Grant J', 'Initials': 'GJ', 'LastName': 'Dornan', 'Affiliation': 'Steadman Philippon Research Institute, Vail, Colorado, USA.'}, {'ForeName': 'Alex W', 'Initials': 'AW', 'LastName': 'Brady', 'Affiliation': 'Steadman Philippon Research Institute, Vail, Colorado, USA.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Philippon', 'Affiliation': 'Steadman Philippon Research Institute, Vail, Colorado, USA.'}]",The American journal of sports medicine,['10.1177/0363546520941859']
2490,32763625,Evaluation of impact-shock on gait after the implementation of two different training programs in older adults.,"BACKGROUND
Gait is negatively affected with increasing age. It is widely accepted that training produces physical-functional improvements in older adults, which can be assessed with numerous physical-functional tests. However, very few studies have been carried out using accelerometry to analyse the training effect on kinetic and kinematic variables in older adults, and there is no one that investigate the effects of two different training programs. Therefore, the aim of this study is to analyse the effects of an interval-walking program and a multicomponent program on the acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed in older adults.
METHODS
23 participants were divided into multicomponent training group [n = 12, 7 female, 71.58 (4.56) years] and interval-walking group [n = 11, 6 female, 69.64 (3.56) years]. We evaluated the participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead.
FINDINGS
After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group. The maximum acceleration values for the head and the stride frequency also increased in the interval-walking group. Lower limb strength improved in both groups.
INTERPRETATION
Given the benefits we found for each of these programs, we encourage their consideration when planning older adults training programs and suggest that multicomponent programs should be introduced prior to the start of walking-based programs.",2020,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","['participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead', 'group [n\xa0=\xa012, 7 female, 71.58 (4.56) years] and interval-walking group [n\xa0=\xa011, 6 female, 69.64 (3.56) years', 'older adults', '23 participants']","['multicomponent training', 'interval-walking program and a multicomponent program']","['Lower limb strength', 'maximum acceleration values', 'stride frequency', 'acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed']","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517763', 'cui_str': '4.56'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",23.0,0.0172172,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sanchis-Sanchis', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Camacho-García', 'Affiliation': 'Departamento de Comunicaciones, Universitat Politècnica de València, Alcoy, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Encarnación-Martínez', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pérez-Soriano', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain. Electronic address: pedro.perez-soriano@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105131']
2491,32766779,Manual Therapy Versus Surgery for Carpal Tunnel Syndrome: 4-Year Follow-Up From a Randomized Controlled Trial.,"OBJECTIVE
No study to our knowledge has investigated the effects longer than 1 year of manual therapy in carpal tunnel syndrome (CTS). The purpose of this study was to investigate the effects of manual therapy versus surgery at 4-year follow-up and to compare the post-study surgery rate in CTS.
METHODS
This randomized controlled trial was conducted in a tertiary public hospital and included 120 women with CTS who were randomly allocated to manual therapy or surgery. The participants received 3 sessions of physical therapy, including desensitization maneuvers of the central nervous system or carpal tunnel release combined with a tendon/nerve gliding exercise program at home. Primary outcome was pain intensity (mean and the worst pain). Secondary outcomes included functional status, symptom severity, and self-perceived improvement measured using a global rating of change scale. Outcomes for this analysis were assessed at baseline, 1 year, and 4 years. The rate of surgical intervention received by each group was assessed throughout the study.
RESULTS
At 4 years, 97 (81%) women completed the study. Between-group changes for all outcomes were not significantly different at 1 year (mean pain: mean difference [MD] = -0.3, 95% CI = -0.9 to 0.3; worst pain: MD = -1.2, 95% CI = -3.6 to 1.2; function: MD = -0.1, 95% CI = -0.4 to 0.2; symptom severity: MD = -0.1, 95% CI = -0.3 to 0.1) and 4 years (mean pain: MD = 0.1, 95% CI = -0.2 to 0.4; worst pain: MD = 0.2, 95% CI = -0.8 to 1.2; function: MD = 0.1, 95% CI = -0.1 to 0.3; symptom severity: MD = 0.2, 95% CI = -0.2 to 0.6). Self-perceived improvement was also similar in both groups. No between-group differences (15% physical therapy vs 13% surgery) in surgery rate were observed during the 4 years.
CONCLUSIONS
In the long term, manual therapy, including desensitization maneuvers of the central nervous system, resulted in similar outcomes and similar surgery rates compared with surgery in women with CTS. Both interventions were combined with a tendon/nerve gliding exercise program at home.
IMPACT
This is the first study to our knowledge to report clinical outcomes and surgical rates during a 4-year follow-up and will inform decisions regarding surgical versus conservative management of CTS.
LAY SUMMARY
Women with CTS may receive similar benefit from a more conservative treatment-manual therapy-as they would from surgery.",2020,"Between-group changes for all outcomes were not significantly different at 1 year (mean pain: mean difference [MD] = -0.3, 95% CI = -0.9 to 0.3; worst pain: MD = -1.2, 95% CI = -3.6 to 1.2; function: MD = -0.1, 95% CI = -0.4 to 0.2; symptom severity: MD = -0.1, 95% CI = -0.3 to 0.1), and 4 years (mean pain: MD = 0.1, 95% CI = ","['carpal tunnel syndrome CTS', 'carpal tunnel syndrome (CTS', 'At 4\xa0years, 97 (81%) women completed the study', 'Carpal Tunnel Syndrome', 'tertiary public hospital and included 120 women with CTS']","['tendon/nerve gliding exercise program at home', 'manual therapy', 'physical therapy including desensitization maneuvers of the central nervous system or carpal tunnel release combined with a tendon/nerve gliding exercise program at home', 'manual therapy or surgery', 'Manual Therapy Versus Surgery']","['surgery rate', 'pain intensity (mean and the worst pain', 'rate of surgical intervention', 'functional status, symptom severity, and self-perceived improvement measured using a global rating of change scale', 'surgery rates']","[{'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0178702', 'cui_str': 'Desensitization therapy'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0196576', 'cui_str': 'Decompression of median nerve'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",120.0,0.131334,"Between-group changes for all outcomes were not significantly different at 1 year (mean pain: mean difference [MD] = -0.3, 95% CI = -0.9 to 0.3; worst pain: MD = -1.2, 95% CI = -3.6 to 1.2; function: MD = -0.1, 95% CI = -0.4 to 0.2; symptom severity: MD = -0.1, 95% CI = -0.3 to 0.1), and 4 years (mean pain: MD = 0.1, 95% CI = ","[{'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Avenida de Atenas s/n, Alcorcón, Madrid, Spain 28922, and Cátedra Institucional en Docencia, Clínica e Investigación en Fisioterapia Terapia Manual, Punción Seca y Ejercicio Terapéutico, Universidad Rey Juan Carlos.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Arias-Buría', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos and Cátedra Institucional en Docencia, Clínica e Investigación en Fisioterapia Terapia Manual, Punción Seca y Ejercicio Terapéutico, Universidad Rey Juan Carlos.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cleland', 'Affiliation': 'Doctor of Physical Therapy Program, Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Pareja', 'Affiliation': 'Department of Neurology and Neurophysiology, Hospital Universitario Fundación, Alcorcón, Madrid, Spain.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Plaza-Manzano', 'Affiliation': 'Department of Radiology, Rehabilitation and Physiotherapy, Universidad Complutense de Madrid, Madrid, Spain; and Instituto de Investigación Sanitaria del Hospital Clinico San Carlos, Madrid, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Ortega-Santiago', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos and Cátedra Institucional en Docencia, Clínica e Investigación en Fisioterapia Terapia Manual, Punción Seca y Ejercicio Terapéutico, Universidad Rey Juan Carlos.'}]",Physical therapy,['10.1093/ptj/pzaa150']
2492,32777381,Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients.,"We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol-related negative behaviors and consequences, and 30-day treatment engagement. The trial design addresses the full spectrum of unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD). In an effort to surmount known ED-based alcohol screening, brief intervention, and referral to treatment process barriers, while addressing racial/ethnic alcohol-related health disparities among Latino groups, this trial will purposively use a digital health tool and seek enrollment of English and/or Spanish speaking self-identified adult Latino ED patients. Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish). The primary outcome will be the number of binge drinking days assessed using the 28-day timeline followback method at 12 months post-randomization. Secondary outcomes will include mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school. A sample size of 820 is necessary to provide 80% power to detect a 1.14 difference between AB-CASI and SC in the primary outcome. Showing efficacy of this promising bilingual ED-based brief intervention tool in Latino patients has the potential to widely and efficiently expand prevention efforts and facilitate meaningful contact with specialized treatment services.",2020,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","['Latino patients', 'English and/or Spanish speaking self-identified adult Latino ED patients', 'Latino emergency department patients', 'unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD']","['automated bilingual computerized alcohol screening and brief intervention (AB-CASI', 'bilingual digital health tool']","['mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school', 'number of binge drinking days assessed using the 28-day timeline followback method']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",,0.0627793,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","[{'ForeName': 'Federico E', 'Initials': 'FE', 'LastName': 'Vaca', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: federico.vaca@yale.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: james.dziura@yale.edu.'}, {'ForeName': 'Fuad', 'Initials': 'F', 'LastName': 'Abujarad', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: fuad.abujarad@yale.edu.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Pantalon', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: michael.pantalon@yale.edu.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Hsiao', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America; Yale School of Medicine, Department of Pediatrics, Section of Emergency Medicine, 100 York St, Suite 1F, New Haven, CT 06511, United States of America. Electronic address: allen.hsiao@yale.edu.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'University of Texas at El Paso, Latino Alcohol and Health Disparities Research Center (LAHDR), Psychology Building, Rooms 102 and 104, El Paso, TX 79968, United States of America. Electronic address: cfield@utep.edu.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': ""D'Onofrio"", 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: gail.donofrio@yale.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106104']
2493,32782010,"The effects of spinach-derived thylakoid supplementation in combination with calorie restriction on anthropometric parameters and metabolic profiles in obese women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND
There is a promising outlook regarding the potential effect of spinach-derived thylakoids in the management of obesity and its associated metabolic disturbances. This research aimed to evaluate the effects of spinach-derived thylakoids supplementation combined with a calorie-restricted diet on anthropometric and metabolic profiles in obese women with the polycystic ovary syndrome (PCOS).
METHODS
In a 12-week double-blind placebo-controlled randomized clinical trial, 48 females with obesity and PCOS were randomly allocated into either intervention (5 g/day thylakoid) or placebo (5 g/day cornstarch) groups along with calorie-restricted diets. Anthropometric measures, physical activity levels, dietary intakes, insulin resistance markers, as well as serum levels of insulin, fasting blood glucose (FBG), non-esterified fatty acids (NEFA), and sex hormones including dehydroepiandrosterone sulfate (DHEAS), follicle-stimulating hormone (FSH), luteinizing hormone (LH), sex hormone-binding globulin (SHBG), and free androgen index (FAI) were evaluated pre-and post-intervention.
RESULTS
After the 12-week intervention, there were significant decreases in weight (- 6.97 ± 0.52 vs. -3.19 ± 0.72 kg; P < 0.001), waist circumference (- 7.78 ± 2.50 vs. -3.73 ± 1.40 cm; P < 0.001), fat mass (- 5.19 ± 0.53 vs. -1.36 ± 0.39 kg; P < 0.001), and insulin levels (- 5.40 ± 1.86 vs. -1.19 ± 0.85 μU/mL; P < 0.001) in the spinach-derived thylakoid group compared to the placebo group. Furthermore, insulin resistance markers and serum levels of testosterone decreased significantly in the thylakoid group compared to the placebo group (P < 0.05). The changes in other parameters did not show significant differences between the two groups.
CONCLUSIONS
Spinach-derived thylakoid supplementation resulted in more favorable improvements in anthropometric indices and insulin sensitivity compared to the calorie restriction alone.
TRIAL REGISTRATION
The study was approved by the Ethics Committee of Research Vice-chancellor of Tabriz University of Medical Sciences, Tabriz, Iran, and was registered in the Iranian Registry of Clinical Trials (registration ID: IRCT20140907019082N9 ).",2020,"Furthermore, insulin resistance markers and serum levels of testosterone decreased significantly in the thylakoid group compared to the placebo group (P < 0.05).","['obese women with polycystic ovary syndrome', 'obese women with the polycystic ovary syndrome (PCOS', '48 females with obesity and PCOS']","['calorie restriction', 'spinach-derived thylakoid supplementation', 'Spinach-derived thylakoid supplementation', 'spinach-derived thylakoids supplementation combined with a calorie-restricted diet', 'calorie-restricted diets', 'placebo']","['weight', 'waist circumference', 'anthropometric indices and insulin sensitivity', 'Furthermore, insulin resistance markers and serum levels of testosterone', 'anthropometric parameters and metabolic profiles', 'fat mass', 'Anthropometric measures, physical activity levels, dietary intakes, insulin resistance markers, as well as serum levels of insulin, fasting blood glucose (FBG), non-esterified fatty acids (NEFA), and sex hormones including dehydroepiandrosterone sulfate (DHEAS), follicle-stimulating hormone (FSH), luteinizing hormone (LH), sex hormone-binding globulin (SHBG), and free androgen index (FAI', 'insulin levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0242949', 'cui_str': 'Spinach'}, {'cui': 'C1879336', 'cui_str': 'Thylakoids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0057277', 'cui_str': 'Dehydroepiandrosterone sulfate'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}]",48.0,0.696044,"Furthermore, insulin resistance markers and serum levels of testosterone decreased significantly in the thylakoid group compared to the placebo group (P < 0.05).","[{'ForeName': 'Fatemeh Pourteymour Fard', 'Initials': 'FPF', 'LastName': 'Tabrizi', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mahdieh Abbasalizad', 'Initials': 'MA', 'LastName': 'Farhangi', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Attar-neishabouri Ave, Golgasht St, Tabriz, 5165665931, Iran. abbasalizad_m@yahoo.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Vaezi', 'Affiliation': ""Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Salar', 'Initials': 'S', 'LastName': 'Hemmati', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Nutrition journal,['10.1186/s12937-020-00601-4']
2494,32787925,Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda.,"BACKGROUND
Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain.
METHODS
We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectiveness-implementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the cost-effectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks.
DISCUSSION
3HP-one of the most promising interventions for TB prevention-will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03934931 ; Registered 2 May 2019.",2020,"The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda.","['people living with HIV (PLHIV', 'people living with HIV in Uganda']","['delivery strategies for short-course tuberculosis preventive therapy', 'isoniazid and rifapentine (3HP']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0740413', 'cui_str': 'Tuberculosis prophylaxis'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0073372', 'cui_str': 'rifapentine'}]",[],,0.196427,"The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda.","[{'ForeName': 'Jillian L', 'Initials': 'JL', 'LastName': 'Kadota', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Musinguzi', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Nabunje', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Welishe', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Jackie L', 'Initials': 'JL', 'LastName': 'Ssemata', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Opira', 'Initials': 'O', 'LastName': 'Bishop', 'Affiliation': 'Makerere University Joint AIDS Program, Kampala, Uganda.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Berger', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Devika', 'Initials': 'D', 'LastName': 'Patel', 'Affiliation': 'Department of Surgery, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Sammann', 'Affiliation': 'Department of Surgery, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Katahoire', 'Affiliation': 'Child Health and Development Centre, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Nahid', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Belknap', 'Affiliation': 'Denver Health and Hospital Authority, Denver, CO, USA.'}, {'ForeName': 'Patrick P J', 'Initials': 'PPJ', 'LastName': 'Phillips', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Namusobya', 'Affiliation': 'University Research Company, Center for Human Services, Department of Defense HIV/AIDS Prevention Program (URC-DHAPP), Kampala, Uganda.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Kamya', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Handley', 'Affiliation': 'Center for Vulnerable Populations at Zuckerberg San Francisco General Hospital and Trauma Center, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Kiwanuka', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Achilles', 'Initials': 'A', 'LastName': 'Katamba', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dowdy', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Fred C', 'Initials': 'FC', 'LastName': 'Semitala', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda. semitala@gmail.com.'}, {'ForeName': 'Adithya', 'Initials': 'A', 'LastName': 'Cattamanchi', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.'}]",Implementation science : IS,['10.1186/s13012-020-01025-8']
2495,32788855,RANDOMIZED CONTROLLED TRIAL OF LIMITED FASCIOTOMY WITH INJECTION OF ADIPOSE GRAFT FOR DUPUYTREN'S DISEASE.,"Objective
Dupuytren's disease is a genetic disorder related to the proliferation of myofibroblasts. The pluripotent property of stem cells present in adipose tissue inhibits myofibroblast proliferation. Our study sought to evaluate the effect of stem cell-rich fat grafts in patients that underwent limited fasciotomy.
Methods
We studied 45 patients, in a single-blind, prospective, randomized clinical trial. All patients underwent limited fasciotomy. In one group, fat graft was injected.
Results
The total passive extension deficit results did not exhibit a significant difference. Fat group exhibited worse functional score at 6 months and 1 year postoperatively, such as higher complication rates (43%), when compared with control group (8%), and more pain at 6 weeks follow-up.
Conclusion
Fat grafting associated with limited fasciotomy promotes worse functional results compared to conventional limited fasciotomy in the short term. However, long-term results and recurrence rates should be further assessed. Level of Evidence II, Prospective comparative study.",2020,"Fat group exhibited worse functional score at 6 months and 1 year postoperatively, such as higher complication rates (43%), when compared with control group (8%), and more pain at 6 weeks follow-up.
","['45 patients', 'patients that underwent limited fasciotomy']",['stem cell-rich fat grafts'],"['complication rates', 'total passive extension deficit', 'recurrence rates', 'pain', 'functional score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0185188', 'cui_str': 'Division of fascia'}]","[{'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",45.0,0.0951548,"Fat group exhibited worse functional score at 6 months and 1 year postoperatively, such as higher complication rates (43%), when compared with control group (8%), and more pain at 6 weeks follow-up.
","[{'ForeName': 'Marina Tommasini C', 'Initials': 'MTC', 'LastName': 'Sambuy', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}, {'ForeName': 'Hugo A', 'Initials': 'HA', 'LastName': 'Nakamoto', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Bolliger', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}, {'ForeName': 'Rames', 'Initials': 'R', 'LastName': 'Mattar', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}, {'ForeName': 'Marcelo R', 'Initials': 'MR', 'LastName': 'Rezende', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}, {'ForeName': 'Teng Hsiang', 'Initials': 'TH', 'LastName': 'Wei', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}]",Acta ortopedica brasileira,['10.1590/1413-785220202804233522']
2496,32730122,Salivary fluoride concentration and retention after rinsing with 0.05 and 0.2% sodium fluoride (NaF) compared with a new high F rinse containing 0.32% NaF.,"OBJECTIVE
To compare salivary fluoride (F) concentration and F retention after rinsing with a new 0.32% sodium fluoride (NaF) rinse and conventional 0.05 and 0.2% NaF rinses.
METHODS
Seventeen subjects (aged 22-26 years), with normal salivary secretion rates, participated in a double blind, cross-over study. In three separate sessions with a minimum washout period of 48 h, they rinsed for 1 min with 10 ml of 0.05, 0.2 or 0.32% NaF mouthrinse. Unstimulated whole saliva was collected before (baseline: 0 min) and after 1, 3, 5, 10, 20, 30, 45 and 60 min. The F concentration was plotted against time, and the area under the curve (AUC) calculated. Salivary F concentration and F retention for the three mouthrinses were compared by a randomized block test, followed by Tukey's test and a paired 2-tailed test.
RESULTS
There was a clear dose-response for AUC 3-60 min; 0.32% > 0.2% > 0.05% ( p < .05). The mean F retention was 0.25 mg for 0.05% NaF, 0.86 mg F for 0.2% Na and 1.31 mg F for 0.32% NaF, ( p < .05).
CONCLUSIONS
The higher salivary F concentration over time and the higher F retention after rinsing with an 0.32% NaF solution suggests a potential application in prevention of caries and dental erosion.",2020,The higher salivary F concentration over time and the higher F retention after rinsing with an 0.32% NaF solution suggests a potential application in prevention of caries and dental erosion.,"['Seventeen subjects (aged 22-26\u2009years), with normal salivary secretion rates, participated in a double blind, cross-over study']","['NaF mouthrinse', 'sodium fluoride (NaF) rinse and conventional 0.05 and 0.2% NaF rinses', 'sodium fluoride (NaF']","['salivary fluoride (F) concentration and F retention', 'Salivary F concentration and F retention', 'F concentration', 'mean F retention', 'Salivary fluoride concentration and retention']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0036104', 'cui_str': 'Salivary secretion'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0331689,The higher salivary F concentration over time and the higher F retention after rinsing with an 0.32% NaF solution suggests a potential application in prevention of caries and dental erosion.,"[{'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Larsson', 'Affiliation': 'Department of Cariology, Faculty of Odontology, Malmö University, Malmö, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Stime', 'Affiliation': 'Kungstandläkarna AB, Stockholm, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hansen', 'Affiliation': 'Lycko Pers väg, Trelleborg, Sweden.'}, {'ForeName': 'Dowen', 'Initials': 'D', 'LastName': 'Birkhed', 'Affiliation': 'Fersens väg, Malmö, Sweden.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ericson', 'Affiliation': 'Department of Cariology, Faculty of Odontology, Malmö University, Malmö, Sweden.'}]",Acta odontologica Scandinavica,['10.1080/00016357.2020.1800085']
2497,32738599,Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial.,"OBJECTIVES
IRX-2 is a primary-cell-derived immune-restorative consisting of multiple human cytokines that act to overcome tumor-mediated immunosuppression and provide an in vivo tumor vaccination to increase tumor infiltrating lymphocytes (TILs). A randomized phase II trial was conducted of the IRX regimen 3 weeks prior to surgery consisting of an initial dose of cyclophosphamide followed by 10 days of regional perilymphatic IRX-2 cytokine injections and daily oral indomethacin, zinc and omeprazole (Regimen 1) compared to the identical regimen without IRX-2 cytokines (Regimen 2).
METHODS
A total of 96 patients with previously untreated, stage II-IV oral cavity SCC were randomized 2:1 to experimental (1) or control (2) regimens (64:32). Paired biopsy and resection specimens from 62 patients were available for creation of tissue microarray (n = 39), and multiplex immunohistology (n = 54). Increases in CD8+ TIL infiltrate scores of at least 10 cells/mm 2 were used to characterize immune responders (IR).
RESULTS
Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2. In p16 negative cancers (n = 26), significant increases in CD8+ and overall TILs were evident in Regimen 1 (p = 0.004, and 0.04 respectively). IRs were more frequent in Regimen 1 (74% vs 31%, p = 0.01). Multiplex immunohistology for PD-L1 expression confirmed an increase in PD-L1 H score for Regimen 1 compared to Regimen 2 (p = 0.11).
CONCLUSIONS
The findings demonstrate significant increases in TILs after perilymphatic IRX-2 injections. Three quarters of patients showed significant immune responses to IRX-2. (NCT02609386).",2020,"RESULTS
Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","['96 patients with previously untreated, stage II-IV oral cavity SCC', 'oral squamous cell carcinoma']","['indomethacin, zinc and omeprazole', 'cyclophosphamide', 'neoadjuvant IRX-2 immunotherapy']","['PD-L1 H score', 'CD8+ TIL infiltrate scores', 'CD8+ infiltrates', 'CD8+ and overall TILs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0758290', 'cui_str': 'IRX 2'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",96.0,0.0184539,"RESULTS
Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","[{'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Wolf', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States. Electronic address: gregwolf@umich.edu.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bellile', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sartor', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rozek', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Dafydd', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Zarins', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'McHugh', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Oral oncology,['10.1016/j.oraloncology.2020.104928']
2498,32739846,Comparison of topical capsaicin and topical piroxicam in the treatment of acute trauma-induced pain: A randomized double-blind trial.,"BACKGROUND
This study aimed to compare the analgesic efficacy of topical capsaicin and topical piroxicam in acute musculoskeletal injuries.
METHODS
This is a prospective, randomized, controlled, double-blinded study. The data for the 67 patients in the piroxicam group and the 69 in the capsaicin group were examined. The initial visual analog scale (VAS) scores were compared with the 60th and 120th minute as well as the 24th and 72nd hour values. Differences between the VAS scores, clinical effectiveness of the treatment and side effects were evaluated.
RESULTS
In the capsaicin group, the mean difference in the delta VAS scores was significantly higher at each measurement time. The mean of the percentage of reduction in the VAS scores of the topical capsaicin group was significantly higher than that in the topical piroxicam group. The highest difference in terms of both outcomes was determined at the 72nd hour VAS change. Mean differences were 1.53 (95% CI: 0.85-2.221) and 19.7 (95% CI: 12.4-27.2) respectively (p < 0.001). In the capsaicin group, the clinical effect of the treatment was found significantly higher (p < 0.01). The difference between the clinical effectiveness of the groups regarding the treatment outcomes was also statistically significant (p < 0.001). There was no significant difference between the patient groups regarding the presence of side effects.
CONCLUSION
Topical capsaicin can be used as an alternative to topical piroxicam initially and at follow-up in patients presenting to the emergency department with acute pain as there were no observable differences in side-effects between the two groups.",2020,"In the capsaicin group, the clinical effect of the treatment was found significantly higher (p < 0.01).","['patients presenting to the emergency department with acute pain', 'acute musculoskeletal injuries', 'acute trauma-induced pain', '67 patients in the']","['topical capsaicin', 'topical capsaicin and topical piroxicam', 'piroxicam', 'capsaicin', 'Topical capsaicin', 'topical piroxicam']","['VAS scores, clinical effectiveness of the treatment and side effects', 'side effects', 'delta VAS scores', 'analgesic efficacy', 'initial visual analog scale (VAS) scores', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C3210186', 'cui_str': 'Capsaicin-containing product in transdermal dose form'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0031990', 'cui_str': 'Piroxicam'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0861012,"In the capsaicin group, the clinical effect of the treatment was found significantly higher (p < 0.01).","[{'ForeName': 'Abdullah Osman', 'Initials': 'AO', 'LastName': 'Kocak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey. Electronic address: abdullahmrym86@gmail.com.'}, {'ForeName': 'Sinem', 'Initials': 'S', 'LastName': 'Dogruyol', 'Affiliation': 'Department of Emergency Medicine, Manisa Merkez Efendi State Hospital, Manisa, Turkey.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Akbas', 'Affiliation': 'Department of Emergency Medicine, Bingol State Hospital, Bingol, Turkey.'}, {'ForeName': 'Tugba Sanalp', 'Initials': 'TS', 'LastName': 'Menekse', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Sultan Tuna Akgol', 'Initials': 'STA', 'LastName': 'Gur', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Meryem Betos', 'Initials': 'MB', 'LastName': 'Kocak', 'Affiliation': 'Department of Familiy Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Cekmen', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Karabuk University, Karabuk, Turkey.'}, {'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Orun', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Namik Kemal University, Tekirdağ, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Cakir', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.05.104']
2499,32748184,Comparison Between Intravenous Nalbuphine and Lidocaine in Reducing Propofol-Induced Injection Pain During Gastroscopy: A Randomized Controlled Trial.,"INTRODUCTION
Intravenous propofol anesthesia is widely used in painless endoscopy. However, propofol injection pain is a common adverse effect. This study investigated the effects of nalbuphine and lidocaine in reducing propofol-induced injection pain.
METHODS
In this double-blind, randomized study, 330 patients were randomly divided into three groups by using a random number table: the nalbuphine group (N), lidocaine group (L), and control group (C). The N, L, and C groups received either 0.1 mg/kg nalbuphine, 0.5 mg/kg lidocaine, or an equivalent volume of normal saline, respectively, as pretreatment drug. Then propofol was manually injected. The primary outcome of this study was the incidence of propofol-induced injection pain, and secondary outcomes included the severity of propofol-induced injection pain, vital signs, and adverse events, including hypotension, bradycardia (< 50 beats/min), hypoxemia (SpO 2 < 90%), drowsiness, physical movement, and cough.
RESULTS
The percentages of patients with propofol injection pain were higher in group C than in group N and group L (64, 34, and 27%, respectively, p < 0.05). The percentage of patients with severe pain after propofol injection was significantly higher in group C than in group N and group L (12, 1, and 0%, respectively, p < 0.05). The doses of propofol in group C and group L were significantly higher than that in group N. More patients suffered hypoxemia in group N than in group C and group L. Then, less patients got physical movement and cough in group N.
CONCLUSIONS
Pretreatment with nalbuphine 0.1 mg/kg was effective in reducing propofol-induced injection pain and propofol consumption. Propofol combined with nalbuphine can be safely and effectively used during gastroscopy.
TRIAL REGISTRATION
Chinese Clinical Trial Registry; ChiCTR1900025438.",2020,"The percentage of patients with severe pain after propofol injection was significantly higher in group C than in group N and group L (12, 1, and 0%, respectively, p < 0.05).","['painless endoscopy', '330 patients']","['Propofol combined with nalbuphine', 'nalbuphine', 'Propofol-Induced Injection Pain', 'lidocaine', 'nalbuphine and lidocaine', 'Intravenous propofol anesthesia', '0.1\xa0mg/kg nalbuphine, 0.5\xa0mg/kg lidocaine', 'propofol', 'Nalbuphine and Lidocaine']","['incidence of propofol-induced injection pain', 'suffered hypoxemia', 'severity of propofol-induced injection pain, vital signs, and adverse events, including hypotension, bradycardia (<\u200950 beats/min), hypoxemia (SpO 2 \u2009<\u200990%), drowsiness, physical movement, and cough', 'propofol injection pain', 'percentage of patients with severe pain']","[{'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C4282968', 'cui_str': 'Propofol Injection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}]",330.0,0.0736753,"The percentage of patients with severe pain after propofol injection was significantly higher in group C than in group N and group L (12, 1, and 0%, respectively, p < 0.05).","[{'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, People's Republic of China.""}, {'ForeName': 'Jinjuan', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, People's Republic of China.""}, {'ForeName': 'Cuiyu', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, People's Republic of China.""}, {'ForeName': 'Yongqi', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, People's Republic of China.""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, People's Republic of China. luyao-mz@163.com.""}]",Pain and therapy,['10.1007/s40122-020-00188-y']
2500,32752306,Thermotherapy Plus Neck Stabilization Exercise for Chronic Nonspecific Neck Pain in Elderly: A Single-Blinded Randomized Controlled Trial.,"Neck pain is a serious problem for public health. This study aimed to compare the effects of thermotherapy plus neck stabilization exercise versus neck stabilization exercise alone on pain, neck disability, muscle properties, and alignment of the neck and shoulder in the elderly with chronic nonspecific neck pain. This study is a single-blinded randomized controlled trial. Thirty-five individuals with chronic nonspecific neck pain were randomly allocated to intervention ( n = 18) or control ( n = 17) groups. The intervention group received thermotherapy with a salt-pack for 30 min and performed a neck stabilization exercise for 40 min twice a day for 5 days (10 sessions). The control group performed a neck stabilization exercise at the same time points. Pain intensity, pain pressure threshold (PPT), neck disability index, muscle properties, and alignment of the neck and shoulder were evaluated before and after the intervention. Significant time and group interactions were observed for pain at rest ( p < 0.001) and during movement ( p < 0.001), and for PPT at the upper-trapezius ( p < 0.001), levator-scapula ( p = 0.003), and splenius-capitis ( p = 0.001). The disability caused by neck pain also significantly changed between groups over time ( p = 0.005). In comparison with the control group, the intervention group showed significant improvements in muscle properties for the upper-trapezius (tone, p = 0.021; stiffness, p = 0.017), levator-scapula (stiffness, p = 0.025; elasticity, p = 0.035), and splenius-capitis (stiffness, p = 0.012), and alignment of the neck ( p = 0.016) and shoulder ( p < 0.001) over time. These results recommend the clinical use of salt pack thermotherapy in addition to neck stabilization exercise as a complementary intervention for chronic nonspecific neck pain control.",2020,"Significant time and group interactions were observed for pain at rest ( p < 0.001) and during movement ( p < 0.001), and for PPT at the upper-trapezius ( p < 0.001), levator-scapula ( p = 0.003), and splenius-capitis ( p = 0.001).","['elderly with chronic nonspecific neck pain', 'chronic nonspecific neck pain control', 'Thirty-five individuals with chronic nonspecific neck pain', 'Chronic Nonspecific Neck Pain in Elderly']","['thermotherapy plus neck stabilization exercise versus neck stabilization exercise alone', 'neck stabilization exercise', 'Thermotherapy Plus Neck Stabilization Exercise', 'thermotherapy with a salt-pack for 30 min and performed a neck stabilization exercise']","['pain, neck disability, muscle properties, and alignment of the neck and shoulder', 'Pain intensity, pain pressure threshold (PPT), neck disability index, muscle properties, and alignment of the neck and shoulder', 'muscle properties for the upper-trapezius', 'pain at rest', 'disability caused by neck pain', 'levator-scapula']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0020548', 'cui_str': 'Thermotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0231493', 'cui_str': 'Muscle property'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0036277', 'cui_str': 'Bone structure of scapula'}]",35.0,0.064528,"Significant time and group interactions were observed for pain at rest ( p < 0.001) and during movement ( p < 0.001), and for PPT at the upper-trapezius ( p < 0.001), levator-scapula ( p = 0.003), and splenius-capitis ( p = 0.001).","[{'ForeName': 'Ho-Jin', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Sung-Hyeon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Suk-Chan', 'Initials': 'SC', 'LastName': 'Hahm', 'Affiliation': 'Graduate School of Integrative Medicine, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Hwi-Young', 'Initials': 'HY', 'LastName': 'Cho', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17155572']
2501,32752932,Development of a novel zolmitriptan intracutaneous microneedle system (Qtrypta™) for the acute treatment of migraine.,"M207 is an investigational intracutaneous microneedle therapeutic system for nonoral zolmitriptan delivery. In a Phase I trial, M207 provided faster absorption with a higher 2 h exposure than oral zolmitriptan. In the pivotal trial evaluating efficacy, tolerability and safety in moderate-to-severe migraine attacks, M207 3.8 mg was superior to placebo in providing freedom from headache pain (42 vs 14%) and freedom from most bothersome symptom (68 vs 43%) 2 h post-dose. Treatment-emergent adverse events were mild and transient and most commonly concerned the application site. In post hoc analyses: pain freedom was sustained in approximately 1/3 of patients; efficacy was observed in migraine headaches that are typically more difficult to treat.",2020,In post hoc analyses: pain freedom was sustained in approximately 1/3 of patients; efficacy was observed in migraine headaches that are typically more difficult to treat.,[],"['oral zolmitriptan', 'zolmitriptan intracutaneous microneedle system (Qtrypta™', 'placebo']","['pain freedom', 'headache pain', 'efficacy, tolerability and safety']",[],"[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0528166', 'cui_str': 'zolmitriptan'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0345793,In post hoc analyses: pain freedom was sustained in approximately 1/3 of patients; efficacy was observed in migraine headaches that are typically more difficult to treat.,"[{'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Rapoport', 'Affiliation': 'The David Geffen School of Medicine at UCLA in Los Angeles, CA\xa090095, USA.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Ameri', 'Affiliation': 'Zosano Pharma, 34790 Ardentech Court, Fremont, CA 94555, USA.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Lewis', 'Affiliation': 'Zosano Pharma, 34790 Ardentech Court, Fremont, CA 94555, USA.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Kellerman', 'Affiliation': 'Zosano Pharma, 34790 Ardentech Court, Fremont, CA 94555, USA.'}]",Pain management,['10.2217/pmt-2020-0041']
2502,32769965,Inotuzumab ozogamicin for relapsed/refractory acute lymphoblastic leukemia: outcomes by disease burden.,"Adults with relapsed/refractory acute lymphoblastic leukemia (R/R ALL) have a poor prognosis, especially if disease burden is high. This post hoc analysis of the phase 3 INO-VATE trial examined the efficacy and safety of inotuzumab ozogamicin (InO) vs. standard of care chemotherapy (SC) among R/R ALL patients with low, moderate, or high disease burden, respectively, defined as bone marrow blasts (BMB) < 50% (n = 53 vs. 48), 50-90% (n = 79 vs. 83), and >90% (n = 30 vs. 30). Patients in the InO vs. SC arm with low, moderate, and high BMB%, respectively, had improved rates of complete remission/complete remission with incomplete hematologic recovery (74% vs. 46% [p = 0.0022], 75 vs. 27% [p < 0.0001], and 70 vs. 17% [p < 0.0001]), and improved overall survival (hazard ratio: 0.64 [p = 0.0260], 0.81 [p = 0.1109], and 0.60 [p = 0.0335]). Irrespective of BMB%, cytopenias were the most common treatment-emergent adverse events, and post-transplant veno-occlusive disease was more common with InO vs. SC. Patients with extramedullary disease or lymphoblastic lymphoma showed similar efficacy and safety outcomes. This favorable benefit-to-risk ratio of InO treatment irrespective of disease burden supports its use in challenging and high disease burden subpopulations. INO-VATE is registered at www.clinicaltrials.gov : #NCT01564784.",2020,"Irrespective of BMB%, cytopenias were the most common treatment-emergent adverse events, and post-transplant veno-occlusive disease was more common with InO vs. SC.","['relapsed/refractory acute lymphoblastic leukemia', 'Patients with extramedullary disease or lymphoblastic lymphoma', 'R/R ALL patients with low, moderate, or high disease burden, respectively, defined as bone marrow blasts (BMB)\u2009<\u200950% (n\u2009=\u200953 vs. 48), 50-90% (n\u2009=\u200979 vs. 83), and >90% (n\u2009=\u200930 vs. 30', 'Adults with relapsed/refractory acute lymphoblastic leukemia (R/R ALL']","['Inotuzumab ozogamicin', 'inotuzumab ozogamicin (InO) vs. standard of care chemotherapy (SC']","['rates of complete remission/complete remission with incomplete hematologic recovery', 'overall survival']","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0079748', 'cui_str': 'Precursor cell lymphoblastic lymphoma'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0439083', 'cui_str': '>90'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1567130', 'cui_str': 'inotuzumab ozogamicin'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0996714,"Irrespective of BMB%, cytopenias were the most common treatment-emergent adverse events, and post-transplant veno-occlusive disease was more common with InO vs. SC.","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'DeAngelo', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, 02215, USA. Daniel_Deangelo@dfci.harvard.edu.'}, {'ForeName': 'Anjali S', 'Initials': 'AS', 'LastName': 'Advani', 'Affiliation': 'Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, 44106, USA.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Marks', 'Affiliation': 'University Hospitals Bristol, Bristol, BS1 3NU, UK.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Stelljes', 'Affiliation': 'Universitätsklinikum Münster, 48149, Münster, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Liedtke', 'Affiliation': 'Stanford Cancer Institute, Stanford, CA, 94304, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stock', 'Affiliation': 'University of Chicago, Chicago, IL, 60637, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gökbuget', 'Affiliation': 'Goethe University Hospital, 60596, Frankfurt, Germany.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Jabbour', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.'}, {'ForeName': 'Akil', 'Initials': 'A', 'LastName': 'Merchant', 'Affiliation': 'Cedars Sinai Medical Center, Los Angeles, CA, 90048, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Vandendries', 'Affiliation': 'Pfizer Inc, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Neuhof', 'Affiliation': 'Pfizer Pharma GmbH, 10785, Berlin, Germany.'}, {'ForeName': 'Hagop', 'Initials': 'H', 'LastName': 'Kantarjian', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, CA, 92697, USA.'}]",Blood cancer journal,['10.1038/s41408-020-00345-8']
2503,32771002,Design and study protocol for a cluster randomized trial of a multi-faceted implementation strategy to increase the uptake of the USPSTF hypertension screening recommendations: the EMBRACE study.,"BACKGROUND
The US Preventive Services Task Force (USPSTF) recommends out-of-office blood pressure (BP) testing to exclude white coat hypertension prior to hypertension diagnosis. Despite improved availability and coverage of home and 24-h ambulatory BP monitoring (HBPM, ABPM), both are infrequently used to confirm diagnoses. We used the Behavior Change Wheel (BCW) framework, a multi-step process for mapping barriers to theory-informed behavior change techniques, to develop a multi-component implementation strategy for increasing out-of-office BP testing for hypertension diagnosis. Informed by geographically diverse provider focus groups (n = 63) exploring barriers to out-of-office testing and key informant interviews (n = 12), a multi-disciplinary team (medicine, psychology, nursing) used rigorous mixed methods to develop, refine, locally adapt, and finalize intervention components. The purpose of this report is to describe the protocol of the Effects of a Multi-faceted intervention on Blood pRessure Actions in the primary Care Environment (EMBRACE) trial, a cluster randomized control trial evaluating whether a theory-informed multi-component strategy increased out-of-office testing for hypertension diagnosis.
METHODS/DESIGN
The EMBRACE Trial patient sample will include all adults ≥ 18 years of age with a newly elevated office BP (≥ 140/90 mmHg) at a scheduled visit with a primary care provider from a study clinic. All providers with scheduled visits with adult primary care patients at enrolled ACN primary care clinics were included. We determined that the most feasible, effective implementation strategy would include delivering education about out-of-office testing, demonstration/instruction on how to perform out-of-office HBPM and ABPM testing, feedback on completion rates of out-of-office testing, environmental prompts/cues via computerized clinical decision support (CDS) tool, and a culturally tailored, locally accessible ABPM testing service. We are currently comparing the effect of this locally adapted multi-component strategy with usual care on the change in the proportion of eligible patients who complete out-of-office BP testing in a 1:1 cluster randomized trial across 8 socioeconomically diverse clinics.
CONCLUSIONS
The EMBRACE trial is the first trial to test an implementation strategy for improving out-of-office testing for hypertension diagnosis. It will elucidate the degree to which targeting provider behavior via education, reminders, and decision support in addition to providing an ABPM testing service will improve referral to and completion of ABPM and HBPMs.
TRIAL REGISTRATION
Clinicaltrials.gov , NCT03480217 , Registered on 29 March 2018.",2020,The EMBRACE trial is the first trial to test an implementation strategy for improving out-of-office testing for hypertension diagnosis.,"['eligible patients who complete out-of-office BP testing in a 1:1 cluster randomized trial across 8 socioeconomically diverse clinics', 'All providers with scheduled visits with adult primary care patients at enrolled ACN primary care clinics were included', 'all adults ≥ 18 years of age with a newly elevated office BP (≥ 140/90 mmHg) at a scheduled visit with a primary care provider from a study clinic']","['Multi-faceted intervention', 'multi-disciplinary team (medicine, psychology, nursing) used rigorous mixed methods to develop, refine, locally adapt, and finalize intervention components']","['Blood pRessure Actions', 'availability and coverage of home and 24-h ambulatory BP monitoring (HBPM, ABPM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0085114', 'cui_str': 'Genes, nf2'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0649948', 'cui_str': '4-(2-(4-hydroxybenzyl)-phenoxy)-N-methylbutylamine'}]",,0.0724221,The EMBRACE trial is the first trial to test an implementation strategy for improving out-of-office testing for hypertension diagnosis.,"[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Moise', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA. nm2562@cumc.columbia.edu.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Phillips', 'Affiliation': 'Division of General Internal Medicine, Weill Cornell Medicine, 1320 York Avenue, New York, NY, 10021, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Carter', 'Affiliation': 'Columbia University School of Nursing, Columbia University Irving Medical Center, 560 West 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Alcantara', 'Affiliation': 'Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Julian', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Anusorn', 'Initials': 'A', 'LastName': 'Thanataveerat', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Schwartz', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Siqin', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Duran', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Kronish', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA.'}]",Implementation science : IS,['10.1186/s13012-020-01017-8']
2504,32779728,Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial - protocol and statistical analysis plan.,"INTRODUCTION
Severe acute respiratory syndrome coronavirus-2 has caused a pandemic of coronavirus disease (COVID-19) with many patients developing hypoxic respiratory failure. Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations. However, corticosteroids have undesirable effects, including longer time to viral clearance. Clinical equipoise on the use of corticosteroids for COVID-19 exists.
METHODS
The COVID STEROID trial is an international, randomised, stratified, blinded clinical trial. We will allocate 1000 adult patients with COVID-19 receiving ≥10 L/min of oxygen or on mechanical ventilation to intravenous hydrocortisone 200 mg daily versus placebo (0.9% saline) for 7 days. The primary outcome is days alive without life support (i.e. mechanical ventilation, circulatory support, and renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, day 90, and 1 year; and health-related quality of life at 1 year. We will conduct the statistical analyses according to this protocol, including interim analyses for every 250 patients followed for 28 days. The primary outcome will be compared using the Kryger Jensen and Lange test in the intention to treat population and reported as differences in means and medians with 95% confidence intervals.
DISCUSSION
The COVID STEROID trial will provide important evidence to guide the use of corticosteroids in COVID-19 and severe hypoxia.",2020,"Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations.","['patients with COVID-19 and severe hypoxia', '1000 adult patients with COVID-19 receiving ≥10\xa0L/min of oxygen or on']","['Low-dose hydrocortisone', 'mechanical ventilation to intravenous hydrocortisone 200\xa0mg daily vs placebo (0.9% saline', 'Corticosteroids']","['longer time to viral clearance', 'Kryger Jensen and Lange test in the intention to treat population', 'health-related quality of life', 'days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy', 'time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality', 'serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C3665438', 'cui_str': 'Juxtapapillary focal retinitis AND retinochoroiditis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",1000.0,0.37202,"Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations.","[{'ForeName': 'Marie Warrer', 'Initials': 'MW', 'LastName': 'Petersen', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Tine Sylvest', 'Initials': 'TS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Helleberg', 'Affiliation': 'Department of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Maj-Brit Nørregaard', 'Initials': 'MN', 'LastName': 'Kjaer', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Carl Johan Steensen', 'Initials': 'CJS', 'LastName': 'Hjortsø', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thomas Steen', 'Initials': 'TS', 'LastName': 'Jensen', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter Buhl', 'Initials': 'PB', 'LastName': 'Hjortrup', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mik', 'Initials': 'M', 'LastName': 'Wetterslev', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Gitte Kingo', 'Initials': 'GK', 'LastName': 'Vesterlund', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Russell', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Vibeke Lind', 'Initials': 'VL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Thoracic Anaesthesiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Tjelle', 'Affiliation': 'Dept. of Anaesthesia and Intensive Care, Hvidovre Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Dept. of Infectious Diseases, Hvidovre Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Dept. of Respiratory Medicine, Hvidovre Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Andreasen', 'Affiliation': 'Dept. of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mohr', 'Affiliation': 'Dept. of Intensive Care, Gentofte Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Dept. of Anaesthesia and Intensive Care, Nordsjaellands Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Lone Musaeus', 'Initials': 'LM', 'LastName': 'Poulsen', 'Affiliation': 'Dept. of Anaesthesia and Intensive Care, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Mette Friberg', 'Initials': 'MF', 'LastName': 'Hitz', 'Affiliation': 'Internal Medicine Dept, Zealand University Hospital, Endocrinology, Køge, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hildebrandt', 'Affiliation': 'Dept. of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Lene Surland', 'Initials': 'LS', 'LastName': 'Knudsen', 'Affiliation': 'Dept. of Infectious Diseases, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Møller', 'Affiliation': 'Dept. of Anaesthesia and Intensive Care, Naestved-Slagelse-Ringsted Hospital, Slagelse, Denmark.'}, {'ForeName': 'Christoffer Grant', 'Initials': 'CG', 'LastName': 'Sølling', 'Affiliation': 'Dept. of Anaesthesia and Intensive Care, Viborg Hospital, Denmark.'}, {'ForeName': 'Anne Craveiro', 'Initials': 'AC', 'LastName': 'Brøchner', 'Affiliation': 'Dept. of Anaesthesia and Intensive Care, Kolding Hospital, Denmark.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Nielsen', 'Affiliation': 'Dept. of Infectious diseases, Aalborg University Hospital, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Christensen', 'Affiliation': 'Dept. of Anaesthesia and Intensive Care, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': 'Dept. of Anaesthesia and Intensive Care, Odense University Hospital, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cronhjort', 'Affiliation': 'Dept. of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rebecka Rubenson', 'Initials': 'RR', 'LastName': 'Wahlin', 'Affiliation': 'Dept. of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Hammond', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia.'}, {'ForeName': 'Vivekanand', 'Initials': 'V', 'LastName': 'Jha', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, New Delhi, India.'}, {'ForeName': 'Sheila Nainan', 'Initials': 'SN', 'LastName': 'Myatra', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13673']
2505,32781283,Efficacy of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in treatment of COVID-19: A randomized controlled trial.,"BACKGROUND
With the global epidemic of coronavirus disease (COVID-19), China has made progress in the prevention and control of the epidemic, and traditional Chinese medicine (TCM) has played a key role in dealing with the disease's effects on the respiratory system. This randomized controlled clinical trial evaluated the clinical efficacy and prognosis of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in patients with COVID-19.
METHODS
A total of 283 patients participated in this clinical trial, and participants were randomly assigned to receive either 1) Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules or 2) Linahua granules, both combined with western medicine, or 3) western medicine alone for 14 days. At the end of the trial, the improvement and resolution rates of clinical symptoms and the rate of patients who progressed to severe disease status were evaluated.
RESULTS
After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05). Huoxiang Zhengqi dropping pills combined with Lianhua Qingwen granules has advantages in the treatment of nausea, vomiting and limb soreness. During treatment, all participants were treated with western medicine, and there was a significant difference in the use of macrolides among the three groups (P < 0.05). Specifically, the utilization rate of antibiotics in the western medicine group was significantly greater than that of the other two groups. Among the 182 diagnosed patients who completed this clinical trial, 13 patients progressed to severe disease, including one case in the Huoxiang + Lianhua group (1.6 %), five cases in the Lianhua group (8.6 %), and seven cases in the western medicine group (11.1 %). There was no statistical differences in this rate among the three groups (P > 0.05). However, the proportion of patients who progressed to severe disease in the Huoxiang + Lianhua group was the lowest, suggesting that the combination of TCM with western medicine has a potential advantage in improving the prognosis of patients with COVID-19.
CONCLUSION
The use of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine may have clinical advantages for COVID-19 patients in improving clinical symptoms, reducing utilization rate of anti-infective drugs, and improving patient prognosis, which could pave the way for the use of complementary medicine in treating this infection.",2020,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","['patients with COVID-19', 'COVID-19', '283 patients participated in this clinical trial, and participants', '182 diagnosed patients']","['Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules', 'Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine']","['utilization rate of antibiotics', 'improvement rate of clinical symptoms', 'nausea, vomiting and limb soreness', 'severe disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1871293', 'cui_str': 'Huoxiang-zhengqi'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",283.0,0.0509695,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","[{'ForeName': 'Mingzhong', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: xmz0001@sohu.com.'}, {'ForeName': 'Jiaxing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tina_yai@126.com.""}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: nana680@sina.com.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 510247444@qq.com.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Min', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Mxj922@sohu.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 562163610@qq.com.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 719834165@qq.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 10029, China. Electronic address: novelzhang@sina.com.'}, {'ForeName': 'Dengying', 'Initials': 'D', 'LastName': 'Yan', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: yandengying@outlook.com.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: suping.lang@gcp-clinplus.com.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: r.e.x@163.com.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Fan', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: an.fan@gcp-clinplus.com.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Ke', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 24929135@qq.com.'}, {'ForeName': 'Xiuyang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: leexiuyang@126.com.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 291560898@qq.com.'}, {'ForeName': 'Manhong', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 43166472@qq.com.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 48302079@qq.com.'}, {'ForeName': 'Jinyue', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 627525649@qq.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 491193488@qq.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 87068066@qq.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zeng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 309452513@qq.com.'}, {'ForeName': 'Chengyin', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 40691534@qq.com.'}, {'ForeName': 'Yujiao', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: luoyuorz@163.com.""}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: dr-whr@foxmail.com.""}, {'ForeName': 'Jiaran', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: 502230253@qq.com.""}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Lian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: lfm565@sohu.com.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Lixiaodong555@126.com.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tongxiaolin@vip.163.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.105126']
2506,32781360,"Intrauterine administration of autologous hCG- activated peripheral blood mononuclear cells improves pregnancy outcomes in patients with recurrent implantation failure; A double-blind, randomized control trial study.","We aimed to investigate the effect of intrauterine administration of autologous hCG-activated PBMCs in RIF women with low Th-17/Treg cell ratio. 248 women with a history of implantation failure volunteered to receive PBMC-therapy. After immunologic consultation and doing flow cytometry analysis, 100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control were enrolled in this study. These 100 patients were randomly divided into two groups as PBMC receiving (n = 50) and controls (n = 50). Then PBMCs were obtained from patients and treated with hCG for 48 h. Afterward, PBMCs were administered into the uterine cavity of the patient in the study group, two days before ET. The concentration of inflammatory cytokines was examined in the supernatant of cultured PBMCs after 2, 24, and 48 h of incubation using the ELISA method. The frequency of Th-17, Treg, and the Th-17/Treg ratio was significantly lower in RIF women than the healthy controls (P < 0.0001). The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001). The pregnancy and live birth rate were significantly increased in women undergoing the PBMC-therapy compared to control (PBS-injecting) group (P = 0.032 and P = 0.047, respectively). The miscarriage rate was considerably lower in PBMC-therapy group (P = 0.029). Our findings suggest that intrauterine administration of autologous in vitro hCG-activated PBMCs improves pregnancy outcomes in patients with at least three IVF/ET failures.",2020,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"['100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control', 'patients with recurrent implantation failure', '100 patients', 'RIF women with low Th-17/Treg cell ratio', '248 women with a history of implantation failure volunteered to receive']","['hCG', 'autologous hCG-activated PBMCs', 'autologous hCG- activated peripheral blood mononuclear cells', 'PBMC-therapy']","['concentration of inflammatory cytokines', 'pregnancy and live birth rate', 'pregnancy outcomes', 'miscarriage rate', 'secretion of inflammatory cytokines', 'frequency of Th-17, Treg, and the Th-17/Treg ratio']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",248.0,0.138794,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Pourmoghadam', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Soltani-Zangbar', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golshan', 'Initials': 'G', 'LastName': 'Sheikhansari', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ramyar', 'Initials': 'R', 'LastName': 'Azizi', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Eghbal-Fard', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Non-Communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Homayoon', 'Initials': 'H', 'LastName': 'Siahmansouri', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Aghebati-Maleki', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Danaii', 'Affiliation': 'Gynecology Department, Eastern Azerbaijan ACECR ART center, Eastern Azerbaijan branch of ACECR, Tabriz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mehdizadeh', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hojjat-Farsangi', 'Affiliation': 'Department of Oncology-Pathology, Immune and Gene Therapy Lab, Cancer Center Karolinska (CCK), Karolinska University Hospital Solna and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Motavalli', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Yousefime@tbzmed.ac.ir.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103182']
2507,32780999,"Prospective, randomized, double-blind, placebo-controlled evaluation of the Pharmacokinetics, Safety and Efficacy of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia.","BACKGROUND
Despite expectant management, preeclampsia remote from term usually results in preterm delivery. Antithrombin, which displays antiinflammatory and anticoagulant properties, may have a therapeutic role in treating preterm preeclampsia, a disorder characterized by endothelial dysfunction, inflammation, and activation of the coagulation system.
OBJECTIVE
This randomized, placebo-controlled clinical trial aimed to evaluate whether intravenous recombinant human antithrombin could prolong gestation and therefore improve maternal and fetal outcomes.
STUDY DESIGN
We performed a double-blind, placebo-controlled trial at 23 hospitals. Women were eligible if they had a singleton pregnancy, early-onset or superimposed preeclampsia at 23 0/7 to 30 0/7 weeks' gestation, and planned expectant management. In addition to standard therapy, patients were randomized to receive either recombinant human antithrombin 250 mg loading dose followed by a continuous infusion of 2000 mg per 24 hours or an identical saline infusion until delivery. The primary outcome was days gained from randomization until delivery. The secondary outcome was composite neonatal morbidity score. A total of 120 women were randomized.
RESULTS
There was no difference in median gestational age at enrollment (27.3 weeks' gestation for the recombinant human antithrombin group [range, 23.1-30.0] and 27.6 weeks' gestation for the placebo group [range, 23.0-30.0]; P=.67). There were no differences in median increase in days gained (5.0 in the recombinant human antithrombin group [range, 0-75] and 6.0 for the placebo group [range, 0-85]; P=.95). There were no differences between groups in composite neonatal morbidity scores or in maternal complications. No safety issues related to recombinant human antithrombin were noted in this study, despite the achievement of supraphysiological antithrombin concentrations.
CONCLUSION
The administration of recombinant human antithrombin in preterm preeclampsia neither prolonged pregnancy nor improved neonatal or maternal outcomes.",2020,There were no differences between groups in composite neonatal morbidity scores or in maternal complications.,"['120 women were randomized', 'Preterm Preeclampsia (PRESERVE-1', '23 hospitals', 'Women were eligible if they had a singleton pregnancy, early onset or superimposed preeclampsia at 23 0/7 to 30 0/7 weeks, and expectant management was planned']","['Placebo', 'Antithrombin', 'recombinant antithrombin', 'Recombinant Antithrombin Versus Placebo', 'placebo']","['composite neonatal morbidity score', 'median gestational age', 'composite neonatal morbidity scores', 'neonatal or maternal outcomes', 'days gained from randomization until delivery', 'median increase in days gained']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",120.0,0.711927,There were no differences between groups in composite neonatal morbidity scores or in maternal complications.,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Paidas', 'Affiliation': 'Yale University School of Medicine, New Haven, CT. Electronic address: mxp1440@med.miami.edu.'}, {'ForeName': 'Allan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'University of Alabama at Birmingham School of Medicine, Birmingham, AL.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Saade', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Ehrenkranz', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Triche', 'Affiliation': 'Brown University School of Medicine, Providence, RI.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Streisand', 'Affiliation': 'rEVO Biologics and LFB USA, Inc, Framingham, MA.'}, {'ForeName': 'Garrett K', 'Initials': 'GK', 'LastName': 'Lam', 'Affiliation': 'University of Tennessee College of Medicine, Memphis, TN.'}, {'ForeName': 'Everett F', 'Initials': 'EF', 'LastName': 'Magann', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': ""University of South Alabama Children's and Women's Hospital, Mobile, AL.""}, {'ForeName': 'Mitchell P', 'Initials': 'MP', 'LastName': 'Dombrowski', 'Affiliation': 'St. John Hospital and Medical Center, Detroit, MI.'}, {'ForeName': 'Erika F', 'Initials': 'EF', 'LastName': 'Werner', 'Affiliation': 'Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Branch', 'Affiliation': 'University of Utah Health, Salt Lake City, UT.'}, {'ForeName': 'Mounira A', 'Initials': 'MA', 'LastName': 'Habli', 'Affiliation': ""Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Grotegut', 'Affiliation': 'Duke University Health System, NC.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'The University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Sherri A', 'Initials': 'SA', 'LastName': 'Longo', 'Affiliation': 'Ochsner Clinic Foundation, New Orleans, LA.'}, {'ForeName': 'Erol', 'Initials': 'E', 'LastName': 'Amon', 'Affiliation': 'St. Louis University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Cleary', 'Affiliation': 'Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'How', 'Affiliation': 'Norton Healthcare, Louisville, KY.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Novotny', 'Affiliation': 'University of Mississippi Medical Center, Jackson, MS.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}, {'ForeName': 'Valerie E', 'Initials': 'VE', 'LastName': 'Whiteman', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Wing', 'Affiliation': 'University of California Irvine, Irvine, CA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Scifres', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Baha M', 'Initials': 'BM', 'LastName': 'Sibai', 'Affiliation': 'University of Texas Health Sciences Center at Houston, Houston, TX.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.08.004']
2508,32798022,Resection following concurrent chemotherapy and high-dose radiation for stage IIIA non-small cell lung cancer.,"OBJECTIVE
Concern exists regarding surgery after thoracic radiation. We aimed to assess early results of anatomic resection following induction therapy with platinum-based chemotherapy and full-dose thoracic radiation for resectable N2+ stage IIIA non-small cell lung cancer.
METHODS
Two prospective trials were recently conducted by NRG Oncology in patients with resectable N2+ stage IIIA non-small cell lung cancer with the primary end point of mediastinal node sterilization following concurrent full-dose chemoradiotherapy (Radiation Therapy Oncology Group trials 0229 and 0839). All surgeons demonstrated postinduction resection expertise. Induction consisted of weekly carboplatin (area under the curve, 2.0) and paclitaxel (50 mg/m 2 ) and concurrent thoracic radiation 60 Gy (0839)/61.2 Gy (0229) in 30 fractions. Patients in study 0839 were randomized 2:1 to weekly panitumumab + chemoradiotherapy or chemoradiotherapy alone during induction. Primary results were similar in all treatment arms and reported previously. Short-term surgical outcomes are reported here.
RESULTS
One hundred twenty-six patients enrolled; 93 (74%) had anatomic resection, 77 underwent lobectomy, and 16 underwent extended resection. Microscopically margin-negative resections occurred in 85 (91%). Fourteen (15%) resections were attempted minimally invasively, including 2 converted without event. Grade 3 or 4 surgical adverse events were reported in 26 (28%), 30-day mortality in 4 (4%) and 90-day mortality in 5 (5%). Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
CONCLUSIONS
Lobectomy was performed safely following full-dose concurrent chemoradiotherapy in these multi-institutional prospective trials; however, increased mortality was noted with extended resections.",2020,"Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
","['patients with resectable N2+ stage IIIA non-small cell lung cancer with the primary end point of mediastinal node sterilization following concurrent full-dose chemoradiotherapy (Radiation Therapy Oncology Group trials 0229 and 0839', 'One hundred twenty-six patients enrolled; 93 (74%) had anatomic resection, 77 underwent lobectomy, and 16 underwent extended resection', 'stage IIIA non-small cell lung cancer']","['anatomic resection following induction therapy with platinum-based chemotherapy and full-dose thoracic radiation', 'paclitaxel', 'carboplatin', 'concurrent chemotherapy and high-dose radiation', 'panitumumab\xa0+\xa0chemoradiotherapy or chemoradiotherapy']","['90-day mortality', 'Microscopically margin-negative resections', 'rates of grade 3 or 4 adverse events', 'mortality', '30-day mortality', 'Grade 3 or 4 surgical adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278983', 'cui_str': 'Non-small cell lung cancer stage IIIA'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0588055', 'cui_str': 'Mediastinal lymph node group'}, {'cui': 'C0038280', 'cui_str': 'Sterilization'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",839.0,0.482473,"Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
","[{'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Donington', 'Affiliation': 'Department of Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Ill. Electronic address: jdonington@uchicago.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Paulus', 'Affiliation': 'Department of Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Ill.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Edelman', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, University of Maryland Medical Center, Baltimore, Md.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Krasna', 'Affiliation': 'Department of Surgery, Jersey Shore University Medical Center, Neptune City, NJ.'}, {'ForeName': 'Quynh-Thu', 'Initials': 'QT', 'LastName': 'Le', 'Affiliation': 'Department of Radiation Oncology, Stanford Cancer Institute, Stanford, Calif.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Suntharalingam', 'Affiliation': 'Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Md.'}, {'ForeName': 'Billy W', 'Initials': 'BW', 'LastName': 'Loo', 'Affiliation': 'Department of Radiation Oncology, Stanford Cancer Institute, Stanford, Calif.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, Pa; Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Bradley', 'Affiliation': 'Department of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Ga.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.03.171']
2509,32799667,Comparing prospective headache diary and retrospective four-week headache questionnaire over 20 weeks: Secondary data analysis from a randomized controlled trial.,"BACKGROUND
Headache diaries and recall questionnaires are frequently used to assess headache frequency and severity in clinical and research settings.
METHODS
Using 20 weeks of data from an intervention trial with 182 participants, we evaluated concordance between an electronic headache diary administered on a daily basis and designed to capture the presence and severity of headaches on an hourly basis (the headache diary) and a recall questionnaire, with retrospective estimation of the number of headache days assessed on a monthly basis. We further examined whether the duration or severity of headaches assessed by the electronic diary impacted concordance between these two measures.
RESULTS
Over the course of four 28-day periods, people with migraine participating in a dietary intervention reported an average of 13.7 and 11.1 headache days in the headache diary and recall questionnaire, respectively.
CONCLUSION
Over time, the concordance between headache days reported in these two measures tended to increase; however, the recall questionnaire headache estimates were lower than the diary measures in all four periods. When analysis was restricted to headaches lasting 8 hours or more, the number of headache days was more closely aligned with days reported in the recall questionnaire, indicating that the accuracy of recall estimates is likely to be influenced by headache duration. Restriction of analyses to moderate-to-severe headaches did not change results as much as headache duration. The findings indicate that recall questionnaires administered on a monthly basis may underestimate headache frequency and therefore should not be used interchangeably with headache diaries. Clinical Trials.gov Identifier : NCT02012790.",2020,"Over time, the concordance between headache days reported in these two measures tended to increase; however, the recall questionnaire headache estimates were lower than the diary measures in all four periods.","['people with migraine participating in a', '182 participants']",['dietary intervention'],"['headache frequency', 'duration or severity of headaches', 'recall questionnaire headache estimates', 'headache duration', 'headache diary and recall questionnaire, respectively']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]",182.0,0.0376969,"Over time, the concordance between headache days reported in these two measures tended to increase; however, the recall questionnaire headache estimates were lower than the diary measures in all four periods.","[{'ForeName': 'Vanessa E', 'Initials': 'VE', 'LastName': 'Miller', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Keturah R', 'Initials': 'KR', 'LastName': 'Faurot', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Olafur S', 'Initials': 'OS', 'LastName': 'Palssson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'MacIntosh', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Chirayath', 'Initials': 'C', 'LastName': 'Suchindran', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Gilson', 'Initials': 'G', 'LastName': 'Honvoh', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gaylord', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Ramsden', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'J Douglas', 'Initials': 'JD', 'LastName': 'Mann', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420949180']
2510,32799709,"Anti-Inflammatory HDL Function, Incident Cardiovascular Events, and Mortality: A Secondary Analysis of the JUPITER Randomized Clinical Trial.","Background High-density lipoprotein (HDL) cholesterol has inverse association with cardiovascular disease. HDL possesses anti-inflammatory properties in vitro, but it is unknown whether this may be protective in individuals with inflammation. Methods and Results The functional capacity of HDL to inhibit oxidation of oxidized low-density lipoprotein (ie, the HDL inflammatory index; HII) was measured at baseline and 12 months after random allocation to rosuvastatin or placebo in a nested case-control study of the JUPITER (Justification for the Use of Statins in Prevention: An Intervention Evaluating Rosuvastatin) trial. There were 517 incident cases of cardiovascular disease and all-cause mortality compared to 517 age- and sex-matched controls. Multivariable conditional logistic regression was used to examine associations of HII with events. Median baseline HII was 0.54 (interquartile range, 0.50-0.59). Twelve months of rosuvastatin decreased HII by a mean of 5.3% (95% CI, -8.9% to -1.7%; P =0.005) versus 1.3% (95% CI, -6.5% to 4.0%; P =0.63) with placebo ( P =0.22 for between-group difference). HII had a nonlinear relationship with incident events. Compared with the reference group (HII 0.5-1.0) with the lowest event rates, participants with baseline HII ≤0.5 had significantly increased risk of cardiovascular disease/mortality (adjusted hazard ratio, 1.53; 95% CI, 1.06-2.21; P =0.02). Furthermore, there was significant ( P =0.002) interaction for HDL particle number with HII, such that having more HDL particles was associated with decreased risk only when HDL was anti-inflammatory. Conclusions In JUPITER participants recruited on the basis of chronic inflammation, HII was associated with incident cardiovascular disease/mortality, with an optimal anti-inflammatory HII range between 0.5 and 1.0. This nonlinear relationship of anti-inflammatory HDL function with risk may account in part for the HDL paradox. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00239681.",2020,"Twelve months of rosuvastatin decreased HII by a mean of 5.3% (95% CI, -8.9% to -1.7%; P =0.005) versus 1.3% (95% CI, -6.5% to 4.0%; P =0.63) with placebo ( P =0.22 for between-group difference).","['individuals with inflammation', 'In JUPITER participants recruited on the basis of chronic inflammation, HII was associated with incident cardiovascular disease/mortality, with an optimal anti-inflammatory HII range between 0.5 and 1.0']","['rosuvastatin', 'rosuvastatin or placebo', 'Registration URL', ' High-density lipoprotein (HDL) cholesterol', 'placebo']","['risk of cardiovascular disease/mortality', 'Median baseline HII', 'Anti-Inflammatory HDL Function, Incident Cardiovascular Events, and Mortality', 'cardiovascular disease and all-cause mortality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242754', 'cui_str': 'Jupiter'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",517.0,0.234502,"Twelve months of rosuvastatin decreased HII by a mean of 5.3% (95% CI, -8.9% to -1.7%; P =0.005) versus 1.3% (95% CI, -6.5% to 4.0%; P =0.63) with placebo ( P =0.22 for between-group difference).","[{'ForeName': 'Oluremi N', 'Initials': 'ON', 'LastName': 'Ajala', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Demler', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Zareen', 'Initials': 'Z', 'LastName': 'Farukhi', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Adelman', 'Affiliation': 'VascularStrategies Plymouth PA.'}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Collins', 'Affiliation': 'VascularStrategies Plymouth PA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Rader', 'Affiliation': 'Department of Genetics University of Pennsylvania Philadelphia PA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.016507']
2511,32807654,Phase II Study of Immunotherapy With Tecemotide and Bevacizumab After Chemoradiation in Patients With Unresectable Stage III Non-Squamous Non-Small-Cell Lung Cancer (NS-NSCLC): A Trial of the ECOG-ACRIN Cancer Research Group (E6508).,"INTRODUCTION
Although chemoradiotherapy (CRT) is the standard of care for patients with unresectable stage III non-small-cell lung cancer (LA-NSCLC), most patients relapse. Tecemotide is a MUC1 antigen-specific cancer immunotherapy vaccine. Bevacizumab improves survival in advanced nonsquamous (NS)-NSCLC and has a role in immune modulation. This phase II trial tested the combination of tecemotide and bevacizumab following CRT in patients with LA-NSCLC.
PATIENTS AND METHODS
Subjects with stage III NS-NSCLC suitable for CRT received carboplatin/paclitaxel weekly + 66 Gy followed by 2 cycles of consolidation carboplatin/paclitaxel ≤ 4 weeks of completion of CRT (Step 1). Patients with partial response/stable disease after consolidation therapy were registered onto step 2, which was 6 weekly tecemotide injections followed by every 6 weekly injections and bevacizumab every 3 weeks for up to 34 doses. The primary endpoint was to determine the safety of this regimen.
RESULTS
Seventy patients were enrolled; 68 patients (median age, 63 years; 56% male; 57% stage IIIA) initiated therapy, but only 39 patients completed CRT and consolidation therapy per protocol, primarily owing to disease progression or toxicity. Thirty-three patients (median age, 61 years; 58% male; 61% stage IIIA) were registered to step 2 (tecemotide + bevacizumab). The median number of step 2 cycles received was 11 (range, 2-25). Step 2 worst toxicity included grade 3, N = 9; grade 4, N = 1; and grade 5, N = 1. Grade 5 toxicity in step 2 was esophageal perforation attributed to bevacizumab. Among the treated and eligible patients (n = 32) who were treated on step 2, the median overall survival was 42.7 months (95% confidence interval, 21.7-63.3 months), and the median progression-free survival was 14.9 months (95% confidence interval, 11.0-20.9 months) from step 1 registration.
CONCLUSIONS
This cooperative group trial met its endpoint, demonstrating tolerability of bevacizumab + tecemotide after CRT and consolidation. In this selected group of patients, the median progression-free survival and overall survival are encouraging. Given that consolidation immunotherapy is now a standard of care following CRT in patients with LA-NSCLC, these results support a role for continued investigation of antiangiogenic and immunotherapy combinations in LA-NSCLC.",2020,"Among the treated and eligible patients (n = 32) who were treated on step 2, the median overall survival was 42.7 months (95% confidence interval, 21.7-63.3 months), and the median progression-free survival was 14.9 months (95% confidence interval, 11.0-20.9 months) from step 1 registration.
","['Patients with partial response/stable disease after consolidation therapy', 'Seventy patients were enrolled; 68 patients (median age, 63 years; 56% male; 57% stage IIIA) initiated therapy, but only 39 patients completed CRT and consolidation therapy per protocol, primarily owing to disease progression or toxicity', 'Cancer (NS-NSCLC', 'Thirty-three patients (median age, 61 years; 58% male; 61% stage IIIA', 'patients with LA-NSCLC', 'Subjects with stage III NS-NSCLC suitable for CRT received', 'Patients With Unresectable Stage III Non-Squamous Non-Small-Cell Lung', 'patients with unresectable stage III non-small-cell lung cancer (LA-NSCLC']","['Immunotherapy With Tecemotide and Bevacizumab', 'Bevacizumab', 'tecemotide and bevacizumab', 'consolidation immunotherapy', 'chemoradiotherapy (CRT', 'carboplatin/paclitaxel weekly\xa0+ 66 Gy followed by 2 cycles of consolidation carboplatin/paclitaxel', 'bevacizumab']","['Grade 5 toxicity', 'median progression-free survival', 'safety of this regimen', 'survival', 'median progression-free survival and overall survival', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0445128', 'cui_str': 'Non-small cell'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C3888078', 'cui_str': 'tecemotide'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",70.0,0.311282,"Among the treated and eligible patients (n = 32) who were treated on step 2, the median overall survival was 42.7 months (95% confidence interval, 21.7-63.3 months), and the median progression-free survival was 14.9 months (95% confidence interval, 11.0-20.9 months) from step 1 registration.
","[{'ForeName': 'Jyoti D', 'Initials': 'JD', 'LastName': 'Patel', 'Affiliation': 'Division of Hematology/Oncology, Northwestern University, Chicago, IL. Electronic address: jd-patel@northwestern.edu.'}, {'ForeName': 'Ju-Whei', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Data Science, Dana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, MA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Carbone', 'Affiliation': 'Department of Medicine, Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Department of Radiation Oncology, Penn State Cancer Institute, Hersey, PA.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Shanker', 'Affiliation': 'Department of Biochemistry and Cancer Biology, Meharry Medical College, Nashville, TN.'}, {'ForeName': 'Maria Teresa P', 'Initials': 'MTP', 'LastName': 'de Aquino', 'Affiliation': 'Department of Biochemistry and Cancer Biology, Meharry Medical College, Nashville, TN.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Department of Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, Sarah Cannon Research Institute, Nashville, TN.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'Department of Medicine, UT Southwestern/Simmons Cancer Center, Dallas, TX.'}, {'ForeName': 'Jane Jijun', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'Illinois Cancer Care, Peoria, IL.'}, {'ForeName': 'Millie S', 'Initials': 'MS', 'LastName': 'Das', 'Affiliation': 'Department of Medicine, VA Palo Alto Health Care, Palo Alto, CA.'}, {'ForeName': 'Mohammed Ali', 'Initials': 'MA', 'LastName': 'Al-Nsour', 'Affiliation': 'Mercy Cancer Centers, Toledo, OH.'}, {'ForeName': 'Christopher S R', 'Initials': 'CSR', 'LastName': 'Dakhil', 'Affiliation': 'Wichita NCORP, Wichita, KS.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Ramalingam', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'Joan H', 'Initials': 'JH', 'LastName': 'Schiller', 'Affiliation': 'Inova Cancer Institute, Fairfax, VA.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.06.007']
2512,32811664,"Biomechanical analysis of ""Barrel hoop plate"" technique for the posterolateral fragments of tibial plateau fractures with different displacement tendency.","OBJECTIVES
The purpose of our study is to evaluate the three-dimensional biomechanical properties of ""Barrel Hoop plate"" in two kinds of artificial posterolateral tibial plateau fracture fragment (PLF) by using of synthetic models, each of which has an initial amplifying displacement tendency.
MATERIAL AND METHODS
Thirty-six tibiae models were randomly assigned into two groups with different displacement tendencies: posterior displacement (PD) and lateral displacement (LD). Each model was then fixed with three patterns: Anterolateral plate (AP), Posterolateral plate (PP), and ""Barrel Hoop plate"" (BHP). Displacement in three axes of vertical, sagittal and horizontal axis was captured by Optotrak Certus motion analysis system. Bluehill 2 software was used for load control and data collection.
RESULTS
In Model-PD, when the load was over 1000 N, the posterior displacement of Group-PP and Group-BHP were less than Group-AP (P<0.01). The inferior displacement in the vertical axis of Group-PP was larger than both Group-AP and Group-BHP in all the loading set (P<0.01). In Model-LD, both of the lateral displacement in Group-AP and Group-BHP was less than that of Group-PP when the load was over 1000 N (P<0.01). The inferior displacement of Group-AP was less than that of Group-PP in the load of 1500 N (P<0.01). Both of the posterior displacement of Group-AP and Group-BHP was less than that of Group-PP when the loading was 1500 N (P<0.01). The stiffness of Group PP was less than that of Group AP (P<0.01).
CONCLUSIONS
The results demonstrated that the 2.7 mm ""Barrel Hoop plate"" had a greater capacity of anti-three-dimension axes displacement of PLF. The 3.5 mm Anterolateral plate had the advantage in anti-lateral displacement and anti-inferior displacement but was weak at anti-posterior displacement of PLF. The 2.7 mm Posterolateral plate was stronger in anti-posterior, however, weak in anti-inferior displacement capacity.",2020,The inferior displacement in the vertical axis of Group-PP was larger than both Group-AP and Group-BHP in all the loading set (P<0.01).,['Thirty-six tibiae models'],"['artificial posterolateral tibial plateau fracture fragment (PLF', 'Barrel Hoop plate', 'displacement tendencies: posterior displacement (PD) and lateral displacement (LD', 'Anterolateral plate (AP), Posterolateral plate (PP), and ""Barrel Hoop plate"" (BHP', 'Barrel hoop plate"" technique']",['advantage in anti-lateral displacement and anti-inferior displacement'],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0262489', 'cui_str': 'Fracture of tibial plateau'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C4319631', 'cui_str': 'Barrel'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0333044', 'cui_str': 'Posterior displacement'}, {'cui': 'C0333046', 'cui_str': 'Lateral displacement'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0640001', 'cui_str': 'bicyclo(2.2.1)hept-5-en-2-yl phenyl sulfoxide'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0333046', 'cui_str': 'Lateral displacement'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}]",,0.0199603,The inferior displacement in the vertical axis of Group-PP was larger than both Group-AP and Group-BHP in all the loading set (P<0.01).,"[{'ForeName': 'Bin-Bin', 'Initials': 'BB', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China. Electronic address: binbin_yoyo@163.com.""}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Biomechanical Laboratory, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China. Electronic address: xmhuhai@hotmail.com.""}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Zhan', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Biomechanical Laboratory, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China. Electronic address: zhanshi4890966@yeah.net.""}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Mei', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China. Electronic address: meijiong@163.com.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China. Electronic address: tzjzzy@163.com.""}, {'ForeName': 'Cong-Feng', 'Initials': 'CF', 'LastName': 'Luo', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China. Electronic address: congfengl@outlook.com.""}]",Injury,['10.1016/j.injury.2020.07.059']
2513,32740891,A Phase I Study to Evaluate Two Doses of Wharton's Jelly-Derived Mesenchymal Stromal Cells for the Treatment of De Novo High-Risk or Steroid-Refractory Acute Graft Versus Host Disease.,"BACKGROUND
Because of their well-described immunosuppressive properties, allogeneic adult human mesenchymal stromal cells (MSC) derived from bone marrow have demonstrated safety and efficacy in steroid refractory acute graft versus host disease (SR aGVHD). Clinical trials have resulted in variable success and an optimal source of MSC has yet to be defined. Based on the importance of maternal-fetal interface immune tolerance, extraembryonic fetal tissues, such as the umbilical cord, may provide an superior tissue source of MSC to mediate immunomodulation in aGVHD.
METHODS
A two-dose cohort trial allogeneic Wharton's Jelly-derived mesenchymal stromal cells (WJMSC, referred to as MSCTC-0010, here) were tested in 10 patients with de novo high risk (HR) or SR aGVHD post allogeneic hematopoietic stem cell transplantation (allo-HCT). Following Good Manufacturing Practices isolation, expansion and cryostorage, WJMSC were thawed and administered via intravenous infusions on days 0 and 7 at one of two doses (low dose cohort, 2 × 10 6 /kg, n = 5; high dose cohort, 10 × 10 6 /kg, n = 5). To evaluate safety, patients were monitored for infusion related toxicity, Treatment Related Adverse Events (TRAE) til day 42, or ectopic tissue formation at day 90. Clinical responses were monitored at time points up to 180 days post infusion. Serum biomarkers ST2 and REG3α were acquired 1 day prior to first MSCTC-0010 infusion and on day 14.
RESULTS
Safety was indicated, e.g., no infusion-related toxicity, no development of TRAE, nor ectopic tissue formation in either low or high dose cohort was observed. Clinical response was suggested at day 28: the overall response rate (ORR) was 70%, 4 of 10 patients had a complete response (CR) and 3 had a partial response (PR). By study day 90, the addition of escalated immunosuppressive therapy was necessary in 2 of 9 surviving patients. Day 100 and 180 post infusion survival was 90% and 60%, respectively. Serum biomarker REG3α decreased, particularly in the high dose cohort, and with REG3α decrease correlated with clinical response.
CONCLUSIONS
Treatment of patients with de novo HR or SR aGVHD with low or high dose MSCTC-0010 was safe: the infusion was well-tolerated, and no TRAEs or ectopic tissue formation was observed. A clinical improvement was seen in about 70% patients, with 4 of 10 showing a complete response that may have been attributable to MSCTC-0010 infusions. These observations indicate safety of two different doses of MSCTC-0010, and suggest that the 10 × 10 6 cells/ kg dose be tested in an expanded randomized, controlled Phase 2 trial. Graphical abstract.",2020,"RESULTS
Safety was indicated, e.g., no infusion-related toxicity, no development of TRAE, nor ectopic tissue formation in either low or high dose cohort was observed.",['10 patients with de novo high risk (HR) or SR aGVHD post allogeneic hematopoietic stem cell transplantation (allo-HCT'],"[""Wharton's Jelly-Derived Mesenchymal Stromal Cells"", ""allogeneic Wharton's Jelly-derived mesenchymal stromal cells (WJMSC"", 'MSCTC-0010']","['Serum biomarkers', 'Adverse Events (TRAE) til day 42, or ectopic tissue formation', 'overall response rate (ORR', 'Serum biomarker REG3α', 'partial response (PR', 'tolerated, and no TRAEs or ectopic tissue formation', 'no infusion-related toxicity, no development of TRAE, nor ectopic tissue formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0230987', 'cui_str': ""Structure of Wharton's jelly""}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008519', 'cui_str': 'Ectopic tissue'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",10.0,0.118327,"RESULTS
Safety was indicated, e.g., no infusion-related toxicity, no development of TRAE, nor ectopic tissue formation in either low or high dose cohort was observed.","[{'ForeName': 'Rupal P', 'Initials': 'RP', 'LastName': 'Soder', 'Affiliation': 'Midwest Stem Cell Therapy Center, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Buddhadeb', 'Initials': 'B', 'LastName': 'Dawn', 'Affiliation': 'University of Nevada, Las Vegas School of Medicine, Las Vegas, NV, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Weiss', 'Affiliation': 'Midwest Institute of Comparative Stem Cell Biotechnology and Department of Anatomy and Physiology, Kansas State University, Manhattan, KS, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Dunavin', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Weir', 'Affiliation': 'Institute for Advancing Medical Innovation Medical Center, University of Kansas, Kansas City, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mitchell', 'Affiliation': 'Midwest Stem Cell Therapy Center, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Meizhang', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Pathology & Laboratory Medicine, Univeristy of Kansas Medical Center, Kansas City, USA.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Shune', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA.'}, {'ForeName': 'Anurag K', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA.'}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Ganguly', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Morrison', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Abdelhakim', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA.'}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Godwin', 'Affiliation': 'Pathology & Laboratory Medicine, Univeristy of Kansas Medical Center, Kansas City, USA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Abhyankar', 'Affiliation': 'Midwest Stem Cell Therapy Center, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'McGuirk', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA. jmcguirk@kumc.edu.'}]",Stem cell reviews and reports,['10.1007/s12015-020-10015-8']
2514,32779057,"Correction of serum potassium with sodium zirconium cyclosilicate in Japanese patients with hyperkalemia: a randomized, dose-response, phase 2/3 study.","BACKGROUND
Sodium zirconium cyclosilicate (SZC) is an oral potassium binder approved to treat hyperkalemia in adults in a number of countries, including Japan.
METHODS
This phase 2/3, randomized, double-blind, placebo-controlled, dose-response study (ClinicalTrials.gov: NCT03127644) was designed to determine the efficacy and safety of SZC in Japanese adults with hyperkalemia. Patients with serum potassium (sK + ) concentrations ≥ 5.1- ≤ 6.5 mmol/L were randomized 1:1:1 to SZC 5 g, SZC 10 g, or placebo three times daily for 48 h (six doses total). The primary efficacy endpoint was the exponential rate of change in sK + over 48 h. The proportion of patients with normokalemia (sK + 3.5-5.0 mmol/L) at 48 h and adverse events (AEs) were also evaluated.
RESULTS
Overall, 103 patients (mean age, 73.2 years; range 50-89 years) received SZC 5 g (n = 34), SZC 10 g (n = 36), or placebo (n = 33). The exponential rate of sK + change from 0 to 48 h versus placebo was - 0.00261 (SZC 5 g) and - 0.00496 (SZC 10 g; both P < 0.0001). At 48 h, the proportions of patients with normokalemia were 85.3%, 91.7%, and 15.2% with SZC 5 g, SZC 10 g, and placebo, respectively. No serious AEs were reported. Hypokalemia (sK + < 3.5 mmol/L) occurred in two patients in the SZC 10 g group; normokalemia was re-established within 6 days and no treatment-related AEs were reported.
CONCLUSION
SZC is effective and well tolerated in Japanese patients with hyperkalemia.",2020,The exponential rate of sK + change from 0 to 48 h versus placebo was - 0.00261,"['adults in a number of countries, including Japan', 'Japanese adults with hyperkalemia', 'Patients with serum potassium (sK + ) concentrations\u2009≥\u20095.1', 'Japanese patients with hyperkalemia', '103 patients (mean age, 73.2\xa0years; range 50-89\xa0years']","['serum potassium with sodium zirconium cyclosilicate', 'SZC', 'Sodium zirconium cyclosilicate (SZC', 'SZC 5', 'placebo']","['efficacy and safety', 'exponential rate of sK + change', 'Hypokalemia', 'exponential rate of change in sK + over 48\xa0h']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",103.0,0.427485,The exponential rate of sK + change from 0 to 48 h versus placebo was - 0.00261,"[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kashihara', 'Affiliation': 'Department of Nephrology and Hypertension, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Nishio', 'Affiliation': 'Nephrology Dialysis Center, Kusatsu General Hospital, Shiga, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Osonoi', 'Affiliation': 'Department of Internal Medicine, Nakakinen Clinic, Ibaraki, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Saka', 'Affiliation': 'Department of Nephrology, Kasugai Municipal Hospital, Aichi, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Imasawa', 'Affiliation': 'Department of Nephrology, Chiba-Higashi Hospital, Chiba, Japan.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Ohtake', 'Affiliation': 'Department of Nephrology, Shonan Kamakura General Hospital, Kanagawa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Mizuno', 'Affiliation': 'Department of Nephrology, Inage Hospital, Chiba, Japan.'}, {'ForeName': 'Yugo', 'Initials': 'Y', 'LastName': 'Shibagaki', 'Affiliation': 'Division of Nephrology and Hypertension, St. Marianna University School of Medicine Hospital, Kanagawa, Japan.'}, {'ForeName': 'Hyosung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Research and Development, AstraZeneca K.K, 1-8-3, Marunouchi, Chiyoda-ku, Tokyo, 100-0005, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Yajima', 'Affiliation': 'Research and Development, AstraZeneca K.K, 1-8-3, Marunouchi, Chiyoda-ku, Tokyo, 100-0005, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Sarai', 'Affiliation': 'Research and Development, AstraZeneca K.K, 1-8-3, Marunouchi, Chiyoda-ku, Tokyo, 100-0005, Japan. nobuaki.sarai@astrazeneca.com.'}]",Clinical and experimental nephrology,['10.1007/s10157-020-01937-1']
2515,32783125,Functional Voice and Swallowing Outcome Analysis After Thyroid Lobectomy: Transoral Endoscopic Vestibular Versus Open Approach.,"BACKGROUND
The transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a scarless remote-access thyroidectomy technique. This study compared subjective and objective voice outcomes and swallowing outcomes of patients who underwent thyroid lobectomy using the TOETVA versus conventional open thyroidectomy (OT).
METHODS
In addition to questionnaires, acoustic and aerodynamic analyses were performed to compare subjective and objective voice outcomes of the two groups. Swallowing outcome analyses were conducted using Swallowing Impairment Index-6 (SIS-6) scores. Assessments were performed preoperatively and 3 and 6 months after surgery. Propensity score matching was performed to compare the outcomes of the two groups.
RESULTS
One hundred and two patients were included in this study (52 TOETVA and 50 OT). Excluding two patients who had vocal cord palsy and open conversion in the TOETVA group, 100 patients completed 3-month postoperative surveys. There were no significant differences between the groups in VAS, GRBAS, or VHI-10 scores at the preoperative and 3- and 6-month assessments. For both groups, there were no significant changes in acoustic or aerodynamic parameters during the 3-6-month postoperative period. The TOETVA group had lower SIS-6 scores at the postoperative 6-month assessment, but the SIS-6 scores after 12 months were similar between groups before and after propensity score matching.
CONCLUSIONS
Following TOETVA lobectomy, there were no significant changes in voice outcomes 3 and 6 months after surgery, and the outcomes were comparable with those of OT. The TOETVA group also had swallowing outcomes that were comparable with the OT group.",2020,"For both groups, there were no significant changes in acoustic or aerodynamic parameters during the 3-6-month postoperative period.","['Excluding two patients who had vocal cord palsy and open conversion in the TOETVA group, 100 patients completed 3-month postoperative surveys', 'patients who underwent', 'One hundred and two patients were included in this study (52 TOETVA and 50 OT']","['thyroid lobectomy using the TOETVA versus conventional open thyroidectomy (OT', 'transoral endoscopic thyroidectomy vestibular approach (TOETVA', 'Thyroid Lobectomy: Transoral Endoscopic Vestibular Versus Open Approach']","['Functional Voice and Swallowing Outcome Analysis', 'lower SIS-6 scores', 'Swallowing Impairment Index-6 (SIS-6) scores', 'VAS, GRBAS, or VHI-10 scores', 'SIS-6 scores', 'subjective and objective voice outcomes', 'swallowing outcomes', 'subjective and objective voice outcomes and swallowing outcomes', 'acoustic or aerodynamic parameters', 'voice outcomes']","[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042928', 'cui_str': 'Vocal cord paralysis'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0392678', 'cui_str': 'Swallowing problem'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",102.0,0.0264362,"For both groups, there were no significant changes in acoustic or aerodynamic parameters during the 3-6-month postoperative period.","[{'ForeName': 'Sungjun', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Tack-Kyun', 'Initials': 'TK', 'LastName': 'Kwon', 'Affiliation': 'Department of Otolaryngology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Young Jun', 'Initials': 'YJ', 'LastName': 'Chai', 'Affiliation': 'Department of Surgery, Seoul Metropolitan Government Seoul National University Boramae Medical Center, 20 Boramaep-ro 5-gil, Dongjak-gu, Seoul, 07061, Republic of Korea. kevinjoon1@gmail.com.'}, {'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Biostatistics, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Doh Young', 'Initials': 'DY', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Kyu Eun', 'Initials': 'KE', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University Hospital and College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hoon Yub', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, KUMC Thyroid Center, Korea University Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ki-Tae', 'Initials': 'KT', 'LastName': 'Hwang', 'Affiliation': 'Department of Surgery, Seoul Metropolitan Government Seoul National University Boramae Medical Center, 20 Boramaep-ro 5-gil, Dongjak-gu, Seoul, 07061, Republic of Korea.'}, {'ForeName': 'Ka Hee', 'Initials': 'KH', 'LastName': 'Yi', 'Affiliation': 'Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}]",World journal of surgery,['10.1007/s00268-020-05731-8']
2516,32798840,Mouse nerve growth factor promotes neurological recovery in patients with acute intracerebral hemorrhage: A proof-of-concept study.,"BACKGROUND
ew drugs were confirmed to be effective in the treatments of neurological dysfunction caused by acute intracerebral hemorrhage (ICH). The present prospective clinical trial aims to evaluate the effect of mouse nerve growth factor (mNGF) on neurological function in patients with acute ICH.
METHODS
60 patients with acute spontaneous ICH were randomized to receive mNGF (mNGF group) and citicoline (control group) for 4 weeks within 24-72 h after onset, respectively. The primary outcome was difference in the neurological functional outcome at 3 months by the modified Rankin Scale score (mRS). The secondary outcomes were the changes in hematoma volume at 4 weeks and 3 months.
RESULTS
There were 55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group). Among the patients, 46 patients finished the trial at 3 months; the odds of a shift towards death or dependence (mRS > 3) at 3 months in the mNGF group were lower than that in the control group with adjustment for age, sex, NIHSS at admission, and hematoma volume at admission (adjusted OR, 0.185; 95%CI, 0.059-0.582; P = 0.0039). The hematoma was gradually reduced in all 46 patients and absorbed after non-surgical treatment at 3 months. There was no significant difference in hematoma volume between the two groups. No serious adverse event was found.
CONCLUSIONS
The administration of mNGF and citicoline was well-tolerated in patients with acute ICH. mNGF was associated with improved neurological function and less disability in patients with ICH. Therefore, the quality of life of patients with ICH may be improved by mNGF.
TRIAL REGISTRATION
The trial is registered with the Chinese Clinical Trial Registry, number ChiCTR1800020258.",2020,There was no significant difference in hematoma volume between the two groups.,"['patients with acute ICH', 'patients with acute intracerebral hemorrhage', '55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group', '60 patients with acute spontaneous ICH', 'patients with ICH']","['mNGF and citicoline', 'mNGF', 'mNGF (mNGF group) and citicoline (control group', 'mouse nerve growth factor (mNGF', 'Mouse nerve growth factor']","['quality of life', 'neurological functional outcome', 'hematoma', 'modified Rankin Scale score (mRS', 'changes in hematoma volume', 'neurological function', 'hematoma volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]","[{'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",60.0,0.0533032,There was no significant difference in hematoma volume between the two groups.,"[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'An', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Rehabilitation Medicine, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Yingsheng', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Shuyuan', 'Initials': 'S', 'LastName': 'Yue', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yongyue', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': 'Laboratory of Neuro-Trauma and Neurodegenerative Disorders, Tianjin Geriatrics Institute, Tianjin Medical University General Hospital, Tianjin, China; Department of Geriatrics, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jianning', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jianningzhang@hotmail.com.'}, {'ForeName': 'Rongcai', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jiang116216@163.com.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117069']
2517,32800642,"Impact of Extremity Manipulation on Postural Sway Characteristics: A Preliminary, Randomized Crossover Study.","OBJECTIVE
Evaluate multisegmental postural sway after upper- vs lower-extremity manipulation.
METHODS
Participants were healthy volunteers (aged 21-40 years). Upper- or lower-extremity manipulations were delivered in a randomized crossover design. Postural assessments were made pre-post manipulation, in floor and rocker board conditions. Analysis included traditional balance measures of pathlength and range and sample entropy (SampEn) to examine the temporal structure of sway of the head, trunk, and surface.
RESULTS
No statistical changes in pathlength or sway range on the ground surface condition were observed. No increases in the amount of sway occurred in any condition. Chiropractic manipulation of either upper or lower extremities led to reductions in traditional measures of postural control on the rocker board. In the anteroposterior direction (sagittal plane), lower-extremity manipulation led to increased trunk SampEn while on the ground, and conversely a decreased SampEn while on the rocker board. In the mediolateral rocker board condition (frontal plane), manipulation elicited a change in SampEn that differed according to site of manipulation; upper-extremity manipulation increased SampEn, whereas lower-extremity manipulation reduced SampEn.
CONCLUSION
Both upper- and lower-extremity manipulation influenced several measures of postural sway on both the ground and the rocker board. Lower-extremity manipulation improved the organization of sway at the trunk (anteroposterior direction) and the board (mediolateral direction). Given the reduction and reorganization of sway metrics seen in this study, we propose extending this line of research to the elderly who are at greatest risk of increased sway and falls.",2020,Both upper- and lower-extremity manipulation influenced several measures of postural sway on both the ground and the rocker board.,['Participants were healthy volunteers (aged 21-40 years'],"['Upper- or lower-extremity manipulations', 'Extremity Manipulation']","['Postural Sway Characteristics', 'multisegmental postural sway', 'amount of sway', 'pathlength or sway range', 'traditional balance measures of pathlength and range and sample entropy (SampEn) to examine the temporal structure of sway of the head, trunk, and surface']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",,0.0207332,Both upper- and lower-extremity manipulation influenced several measures of postural sway on both the ground and the rocker board.,"[{'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Malaya', 'Affiliation': 'Center for Neuromotor and Biomechanics Research, University of Houston, Houston, Texas and Research Center, Parker University, Dallas, Texas.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Haworth', 'Affiliation': 'Department of Human Movement Science, Oakland University, Rochester, Michigan.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Pohlman', 'Affiliation': 'Research Center, Parker University, Dallas, Texas.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'College of Chiropractic, Parker University, Nashoba, Oklahoma.'}, {'ForeName': 'Dean L', 'Initials': 'DL', 'LastName': 'Smith', 'Affiliation': 'Department of Kinesiology and Health, Miami University, Oxford, Ohio and Essence of Wellness Chiropractic Center, Eaton, Ohio. Electronic address: smithdL2@miamioh.edu.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.02.014']
2518,32805205,"Lubiprostone in patients with non-alcoholic fatty liver disease: a randomised, double-blind, placebo-controlled, phase 2a trial.","BACKGROUND
The laxative drug lubiprostone improves intestinal permeability in healthy volunteers. We aimed to assess efficacy and safety of lubiprostone in patients with non-alcoholic fatty liver disease (NAFLD) with constipation via attenuation of intestinal permeability.
METHODS
This randomised, double-blind, placebo-controlled, phase 2a study in Yokohama City University Hospital, Japan, recruited patients (aged 20-85 years) with NAFLD and constipation, alanine aminotransferase (ALT) at least 40 U/L, liver stiffness (≤6·7 kPa), and hepatic fat fraction at least 5·2% when assessed by MRI-proton density fat fraction. Eligible patients were randomly assigned (11:10:9) by a computer-based system and stratified by age and sex to receive 24 μg lubiprostone, 12 μg lubiprostone, or placebo, orally, once per day for 12 weeks. The primary endpoint was the absolute changes in ALT at 12 weeks. Efficacy analysis was done by intention to treat. Safety was assessed in all treated patients. This trial was registered with University Hospital Medical Information Network Clinical Trials Registry (UMIN000026635).
FINDINGS
Between March 24, 2017, and April 3, 2018, we screened 288 patients, of whom 150 (52%) were randomly assigned to treatment: 55 patients were assigned to receive 24 μg lubiprostone, 50 to receive 12 μg lubiprostone, and 45 to receive placebo. A greater decrease in the absolute ALT levels from baseline to 12 weeks was seen in the 24 μg lubiprostone group (mean -13 U/L [SD 19]) than in the placebo group (1 U/L [24]; mean difference -15 U/L [95% CI -23 to -6], p=0·0007) and in the 12 μg lubiprostone group (-12 U/L [21]) than in the placebo group (mean difference -13 U/L [-22 to -5], p=0·0023). 18 (33%) of 55 patients in the 24 μg group had at least one adverse event, as did three (6%) of 47 patients in the 12 μg group and three (7%) of 43 in the placebo group. The most common adverse event was diarrhoea (17 [31%] of patients in the 24 μg group, three [6%] in the 12 μg group, none in the placebo group). No life-threatening events or treatment-related deaths occurred.
INTERPRETATION
Lubiprostone was well tolerated and reduced the levels of liver enzymes in patients with NAFLD and constipation. Further studies are necessary to better define the efficacy and tolerability of lubiprostone in patients with NAFLD without constipation.
FUNDING
Mylan EPD G.K.",2020,"No life-threatening events or treatment-related deaths occurred.
","['288 patients, of whom 150 (52%) were randomly assigned to treatment: 55 patients', 'healthy volunteers', 'patients with NAFLD without constipation', 'Yokohama City University Hospital, Japan, recruited patients (aged 20-85 years) with NAFLD and constipation, alanine aminotransferase (ALT', 'patients with non-alcoholic fatty liver disease', 'patients with non-alcoholic fatty liver disease (NAFLD) with constipation via attenuation of intestinal permeability', 'Between March 24, 2017, and April 3, 2018', 'patients with NAFLD and constipation', 'Eligible patients']","['computer-based system and stratified by age and sex to receive 24 μg lubiprostone, 12 μg lubiprostone, or placebo', 'U/L', 'Lubiprostone', 'laxative drug lubiprostone', '24 μg lubiprostone, 50 to receive 12 μg lubiprostone, and 45 to receive placebo', 'lubiprostone', 'placebo']","['absolute ALT levels', 'Safety', 'intestinal permeability', 'diarrhoea', 'adverse event', 'efficacy and tolerability', 'efficacy and safety', 'absolute changes in ALT', 'levels of liver enzymes', 'liver stiffness (≤6·7 kPa), and hepatic fat fraction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1684405', 'cui_str': 'lubiprostone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0282090', 'cui_str': 'Laxative'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0263428', 'cui_str': 'Ulerythema ophryogenes'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",55.0,0.708799,"No life-threatening events or treatment-related deaths occurred.
","[{'ForeName': 'Takaomi', 'Initials': 'T', 'LastName': 'Kessoku', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Palliative Medicine, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Imajo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ozaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Iwaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Honda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Palliative Medicine, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Gastroenterology, International University of Health and Welfare Atami Hospital, Atami, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Tomeno', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Gastroenterology, International University of Health and Welfare Atami Hospital, Atami, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Higurashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Yoneda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kirikoshi', 'Affiliation': 'Clinical Laboratory Department, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Taguri', 'Affiliation': 'Department of Data Science, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Usuda', 'Affiliation': 'Department of Pharmacology, Shimane University Faculty of Medicine, Izumo, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Department of Pharmacology, Shimane University Faculty of Medicine, Izumo, Japan.'}, {'ForeName': 'Noritoshi', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Oncology, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan. Electronic address: nakajima-tky@umin.ac.jp.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30216-8']
2519,32812137,"Simple Wound Irrigation in the Postoperative Treatment for Surgically Drained Spontaneous Soft Tissue Abscesses: A Prospective, Randomized Controlled Trial.","BACKGROUND
Soft tissue abscesses are among the most frequently encountered medical problems treated by different surgeons. Standard therapy remains incision and drainage with sterile saline irrigation during postoperative wound healing period. Aim of this prospective randomized controlled trial was to compare sterile irrigation versus nonsterile irrigation.
STUDY DESIGN
A single center randomized controlled trial was performed to investigate postoperative wound irrigation. The control group used sterile irrigation, and the intervention group used nonsterile irrigation. Primary endpoints were reinfection and reintervention rates, assessed during follow-up controls for up to 2 years. Secondary endpoints were the duration of wound healing, inability to work, pain and quality of life.
RESULTS
Between 04/2016 and 05/2017, 118 patients were randomized into two groups, with 61 allocated to the control- and 57 to the intervention group. Reinfection occurred in a total of 4 cases (6.6%) in the sterile protocol and 4 (7%) in the nonsterile protocol. Quality of life and pain values were comparable during the wound healing period, and patients treated according to the nonsterile irrigation protocol used significantly fewer wound care service teams. Despite equal wound persistence rates, a substantially shorter amount of time off from work was reported in the nonsterile protocol group (p value 0.086).
CONCLUSION
This prospective, randomized trial indicates that a nonsterile irrigation protocol for patients operated on for soft tissue abscesses is not inferior to the standard sterile protocol. Moreover, a nonsterile irrigation protocol leads to a shorter period of inability to work with comparable pain and quality of life scores during the wound healing period.",2020,"Quality of life and pain values were comparable during the wound healing period, and patients treated according to the nonsterile irrigation protocol used significantly fewer wound care service teams.","['patients operated on for soft tissue abscesses is not inferior to the standard sterile protocol', '118 patients', 'Between 04/2016 and 05/2017', 'Surgically Drained Spontaneous Soft Tissue Abscesses']","['sterile irrigation versus nonsterile irrigation', 'sterile irrigation, and the intervention group used nonsterile irrigation', 'sterile saline irrigation', 'nonsterile irrigation protocol', 'Simple Wound Irrigation']","['Reinfection', 'pain and quality of life scores', 'Quality of life and pain values', 'duration of wound healing, inability to work, pain and quality of life', 'reinfection and reintervention rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0150410', 'cui_str': 'Irrigation of wound'}]","[{'cui': 'C0205339', 'cui_str': 'Reinfection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C4049481', 'cui_str': 'Inability to work'}]",118.0,0.0682539,"Quality of life and pain values were comparable during the wound healing period, and patients treated according to the nonsterile irrigation protocol used significantly fewer wound care service teams.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Oehme', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery at the University Hospital Dresden, Carl Gustav Carus University Dresden, P.O. Box 01307, Dresden, Germany. florianoehme85@gmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rühle', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, P.O. Box 69120, Heidelberg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Börnert', 'Affiliation': 'Department of Trauma Surgery, Cantonal Hospital Obwalden, Brünigstrasse 181, P.O. Box 6060, 6060, Sarnen, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hempel', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery at the University Hospital Dresden, Carl Gustav Carus University Dresden, P.O. Box 01307, Dresden, Germany.'}, {'ForeName': 'B-C', 'Initials': 'BC', 'LastName': 'Link', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Cantonal Hospital Lucerne, Spitalstrasse 16, P.O. Box 6000, 6000, Lucerne, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Babst', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Cantonal Hospital Lucerne, Spitalstrasse 16, P.O. Box 6000, 6000, Lucerne, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Metzger', 'Affiliation': 'Department of General Surgery, Cantonal Hospital Lucerne, Spitalstrasse 16, P.O. Box 6000, 6000, Lucerne, Switzerland.'}, {'ForeName': 'F J-P', 'Initials': 'FJ', 'LastName': 'Beeres', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Cantonal Hospital Lucerne, Spitalstrasse 16, P.O. Box 6000, 6000, Lucerne, Switzerland.'}]",World journal of surgery,['10.1007/s00268-020-05738-1']
2520,32812177,Reduction of breast lymphoedema secondary to breast cancer: a randomised controlled exercise trial.,"BACKGROUND
Breast lymphoedema can occur following surgical treatment for breast cancer. We investigated whether an exercise program reduced breast lymphoedema symptoms compared to a non-exercise control group.
METHODS
A single-blinded randomised controlled trial was conducted in which women with stable breast lymphoedema (n = 89) were randomised into an exercise (n = 41) or control (n = 47) group. The intervention comprised a 12-week combined aerobic and resistance training program, supervised weekly by an accredited exercise physiologist. All participants completed a weekly symptoms diary and were assessed monthly to ensure that there was no exacerbation of their lymphoedema. Changes in the breast were captured physically with ultrasound and bioimpedance spectroscopy and changes in symptoms were captured using European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer (BR23) and Lymphoedema Symptom Intensity and Distress questionnaires.
RESULTS
The exercise group reported a greater reduction in breast-related symptoms than the control group, assessed by the EORTC BR23 breast symptom questions. Measures of extracellular fluid, assessed with bioimpedance spectroscopy ratio, decreased in the exercise group compared to the control group. No significant difference was detected in dermal thickness in the breast, assessed by ultrasound. Session attendance in the exercise sessions was high, with two musculoskeletal adverse events reported, but no exacerbations of lymphoedema observed.
CONCLUSION
Combined resistance and aerobic exercise training is safe for women living with breast lymphoedema. Preliminary data suggest exercise training can reduce breast lymphoedema symptoms to a greater extent than usual care.",2020,"The exercise group reported a greater reduction in breast-related symptoms than the control group, assessed by the EORTC BR23 breast symptom questions.","['breast cancer', 'breast lymphoedema secondary to breast cancer', 'women living with breast lymphoedema', 'women with stable breast lymphoedema (n\u2009=\u200989']","['exercise training', 'Combined resistance and aerobic exercise training', 'exercise program', 'combined aerobic and resistance training program, supervised weekly by an accredited exercise physiologist', 'exercise (n\u2009=\u200941) or control']","['breast lymphoedema symptoms', 'Session attendance', 'dermal thickness', 'bioimpedance spectroscopy ratio', 'Breast Cancer (BR23) and Lymphoedema Symptom Intensity and Distress questionnaires', 'breast-related symptoms', 'Cancer (EORTC']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0260141', 'cui_str': 'Physiologist'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",89.0,0.0640697,"The exercise group reported a greater reduction in breast-related symptoms than the control group, assessed by the EORTC BR23 breast symptom questions.","[{'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Kilbreath', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney, Sydney, Australia. sharon.kilbreath@sydney.edu.au.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Ward', 'Affiliation': 'School of Chemistry and Molecular Biosciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Degnim', 'Affiliation': 'Department of Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Hackett', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Skinner', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Black', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney, Sydney, Australia.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05863-4']
2521,32815921,Effects of dapagliflozin on blood pressure variability in patients with prediabetes and prehypertension without pharmacological treatment: a randomized trial.,"AIM
The aim of the study was to evaluate the effect of dapagliflozin on blood pressure variability (BPV) in patients with prediabetes and prehypertension without pharmacological treatment.
METHODS
A double-blind, randomized, placebo-controlled clinical study was performed in 30 patients (30-60 years) diagnosed with prediabetes and prehypertension. Study subjects were divided into two groups: a 10-mg dose of dapagliflozin was administered daily before breakfast for 12 weeks in 15 patients or placebo in the remaining 15 patients. At the beginning and end of the study, clinical and metabolic evaluations were performed, and the 24-h BPV was calculated.
RESULTS
Dapagliflozin significantly decreased body weight (P = 0.010), BMI (P = 0.011), fasting plasma glucose (P = 0.002), glycated hemoglobin A1c (P = 0.004), office systolic blood pressure (SBP) (P = 0.001), office diastolic blood pressure (DBP) (P = 0.011), 24-h SBP (121 ± 8 vs. 117 ± 11 mmHg, P = 0.046), nighttime SBP (114 ± 11 vs. 108 ± 10 mmHg, P = 0.017), nocturnal mean arterial pressure (P = 0.043), and nocturnal hypertensive load (P = 0.015); and it significantly increased the percentage of the dipper circadian BP pattern (16.7 vs. 30.8%, P = 0.047). After the administration of dapagliflozin, some of the patients did not meet the diagnostic criteria for prediabetes (26.9%) or prehypertension (26.9%).
CONCLUSIONS
The administration of 10 mg dapagliflozin once daily for 90 days in patients with prediabetes and prehypertension decreased BPV by reducing 24-h and nighttime SBP, and increasing the dipper circadian BP pattern.",2020,"RESULTS
Dapagliflozin significantly decreased body weight (P = 0.010), BMI (P = 0.011), fasting plasma glucose (P = 0.002), glycated hemoglobin A1c (P = 0.004), office systolic blood pressure (SBP) (P = 0.001), office diastolic blood pressure (DBP) (P = 0.011), 24-h SBP (121 ± 8 vs. 117 ± 11 mmHg, P = 0.046), nighttime SBP (114 ± 11 vs. 108 ± 10 mmHg, P = 0.017), nocturnal mean arterial pressure (P = 0.043), and nocturnal hypertensive load (P = 0.015); and","['30 patients (30-60\u2009years) diagnosed with prediabetes and prehypertension', 'patients with prediabetes and prehypertension without pharmacological treatment']","['dapagliflozin', 'placebo']","['24-h SBP', 'nocturnal hypertensive load', 'body weight', 'glycated hemoglobin A1c', 'office systolic blood pressure (SBP', 'nocturnal mean arterial pressure', 'dipper circadian BP pattern', 'BMI', 'blood pressure variability', 'office diastolic blood pressure (DBP', 'percentage of the dipper circadian BP pattern', 'blood pressure variability (BPV', 'fasting plasma glucose', 'nighttime SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0326560', 'cui_str': 'Cinclidae'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",30.0,0.0519784,"RESULTS
Dapagliflozin significantly decreased body weight (P = 0.010), BMI (P = 0.011), fasting plasma glucose (P = 0.002), glycated hemoglobin A1c (P = 0.004), office systolic blood pressure (SBP) (P = 0.001), office diastolic blood pressure (DBP) (P = 0.011), 24-h SBP (121 ± 8 vs. 117 ± 11 mmHg, P = 0.046), nighttime SBP (114 ± 11 vs. 108 ± 10 mmHg, P = 0.017), nocturnal mean arterial pressure (P = 0.043), and nocturnal hypertensive load (P = 0.015); and","[{'ForeName': 'Cristal', 'Initials': 'C', 'LastName': 'Díaz-Cruz', 'Affiliation': 'Departamento de Fisiología, Instituto de Terapéutica Experimental y Clínica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Jalisco, México.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'González-Ortiz', 'Affiliation': ''}, {'ForeName': 'Lizet Y', 'Initials': 'LY', 'LastName': 'Rosales-Rivera', 'Affiliation': ''}, {'ForeName': 'Anayeli de J', 'Initials': 'AJ', 'LastName': 'Patiño-Laguna', 'Affiliation': ''}, {'ForeName': 'Zaire G', 'Initials': 'ZG', 'LastName': 'Ramírez-Rodríguez', 'Affiliation': ''}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Díaz-Cruz', 'Affiliation': ''}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Martínez-Abundis', 'Affiliation': ''}]",Blood pressure monitoring,['10.1097/MBP.0000000000000479']
2522,32815922,Ambulatory blood pressure variability and combined exercise training: comparison between hypertensive and normotensive postmenopausal women.,"AIM
The aim of the study was to verify the effects of moderate combined aerobic and resistance exercises training in ambulatory blood pressure (ABPM) and its variability in hypertensive and normotensive postmenopausal women.
METHODS
Twenty-six participants were divided into two groups: hypertensive (HT = 13) and normotensive (NT = 13). They performed 30 sessions of combined exercises (aerobic and resistance exercises at same session) over 10 weeks. We evaluated: resting BP and 24-h ABPM with systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), and heart rate (HR). To evaluate blood pressure variability (BPV), the following were considered: 24-h SD (SD24), the mean diurnal and nocturnal deviations (SDdn), average real variability (ARV24).
RESULTS
The two-way analysis of variance showed no difference in ABPM nor BPV responses after training between groups. Both HT and NT groups had similar BP reductions in 24-h DBP (P < 0.01; ΔNT = -3.1 ± 1.1, ΔHT = -1.8 ± 1.2 mmHg), 24-h area under the curve of DBP (P = 0.01; ΔNT = -73±105, ΔHT = -44 ± 115 mmHg), and wake DBP (P < 0.01; ΔNT = -3.4 ± 1.2, ΔHT = -1.8 ± 1.3 mmHg), without differences in BPV responses. Moreover, HT women had higher overall SBP SDdn (P = 0.01), SBP ARV (P = 0.02), and MBP ARV (P < 0.01) than NT women.
CONCLUSION
Ten-week combined exercise training resulted in similar BP reductions in hypertensive and normotensive postmenopausal women, but not in BPV responses.",2020,"Both HT and NT groups had similar BP reductions in 24-h DBP (P < 0.01; ΔNT = -3.1 ± 1.1, ΔHT = -1.8 ± 1.2 mmHg), 24-h area under the curve of DBP (P = 0.01; ΔNT = -73±105, ΔHT = -44 ± 115 mmHg), and wake DBP (P < 0.01; ΔNT = -3.4 ± 1.2, ΔHT = -1.8 ± 1.3 mmHg), without differences in BPV responses.","['Twenty-six participants were divided into two groups: hypertensive (HT\u2009=\u200913) and normotensive (NT\u2009=\u200913', 'hypertensive and normotensive postmenopausal women']","['combined exercises (aerobic and resistance exercises', 'exercise training', 'combined exercise training', 'moderate combined aerobic and resistance exercises training']","['24-h SD (SD24), the mean diurnal and nocturnal deviations (SDdn), average real variability (ARV24', 'BPV responses', 'BP reductions', 'SBP ARV', 'ambulatory blood pressure (ABPM', 'resting BP and 24-h ABPM with systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), and heart rate (HR', 'Ambulatory blood pressure variability', 'ABPM nor BPV responses', 'BP reductions in 24-h DBP', '24-h area under the curve of DBP', 'MBP ARV', 'blood pressure variability (BPV', 'overall SBP SDdn', 'wake DBP']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0442696', 'cui_str': 'Waking'}]",26.0,0.0178929,"Both HT and NT groups had similar BP reductions in 24-h DBP (P < 0.01; ΔNT = -3.1 ± 1.1, ΔHT = -1.8 ± 1.2 mmHg), 24-h area under the curve of DBP (P = 0.01; ΔNT = -73±105, ΔHT = -44 ± 115 mmHg), and wake DBP (P < 0.01; ΔNT = -3.4 ± 1.2, ΔHT = -1.8 ± 1.3 mmHg), without differences in BPV responses.","[{'ForeName': 'Igor Moraes', 'Initials': 'IM', 'LastName': 'Mariano', 'Affiliation': 'Physical Education Department, Federal University of Uberlandia, Aparecida, Uberlândia, Brazil.'}, {'ForeName': 'Juliene Gonçalves Costa', 'Initials': 'JGC', 'LastName': 'Dechichi', 'Affiliation': ''}, {'ForeName': 'Larissa Aparecida Santos', 'Initials': 'LAS', 'LastName': 'Matias', 'Affiliation': ''}, {'ForeName': 'Mateus de Lima', 'Initials': 'ML', 'LastName': 'Rodrigues', 'Affiliation': ''}, {'ForeName': 'Jaqueline Pontes', 'Initials': 'JP', 'LastName': 'Batista', 'Affiliation': ''}, {'ForeName': 'Tállita Cristina Ferreira', 'Initials': 'TCF', 'LastName': 'de Souza', 'Affiliation': ''}, {'ForeName': 'Ana Luiza', 'Initials': 'AL', 'LastName': 'Amaral', 'Affiliation': ''}, {'ForeName': 'Victor Hugo Vilarinho', 'Initials': 'VHV', 'LastName': 'Carrijo', 'Affiliation': ''}, {'ForeName': 'Guilherme Morais', 'Initials': 'GM', 'LastName': 'Puga', 'Affiliation': ''}]",Blood pressure monitoring,['10.1097/MBP.0000000000000480']
2523,32818573,"Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study.","ETHNOPHARMACOLOGICAL RELEVANCE
Ashwagandha (Withania somnifera (L.) Dunal.) is long known for its sleep-inducing effects. Ashwagandha can be proposed as an alternative to the recommended present treatments for insomnia. This study aimed to evaluate the pharmacological effect of Ashwagandha root extract on sleep in healthy subjects and also in the subjects having insomnia.
MATERIAL AND METHODS
We performed a randomized, parallel-group, stratified design, placebo-controlled study. A total of 80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia) were assigned to two groups, either Ashwagandha or placebo and studied for 8-weeks. The assessment was done based on the sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake After Sleep Onset, Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire. Safety and adverse events along with the concomitant medication were also assessed.
RESULTS
In both healthy and insomnia subjects, there was a significant improvement in the sleep parameters in the Ashwagandha root extract supplemented group. The improvement was found more significant in insomnia subjects than healthy subjects. Repeat measure Analysis of variance (ANOVA) confirmed the significant improvement in SOL (p 0.013), HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients. A two-way ANOVA was used to confirm the outcomes that denoted sleep onset latency (p < 0.0001) and sleep efficiency (p < 0.0001) as the most improved parameters, followed by TST (p < 0.002) and WASO(p < 0.040). All these parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality) were also statistically assessed for the significant improvement within the group both for the treatment, and the placebo groups in the healthy and the insomnia datasets. Obtained results suggest statistically significant (p < 0.0001) changes between the baseline values and the end of the study results except for the HAM-A and the mental alertness scoresn the healthy subject group.
CONCLUSION
The present study confirms that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Ashwagandha root extract was well tolerated by all the participants irrespective of their health condition and age. Additional clinical trials are required to generalize the outcome.",2021,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","['80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia', 'healthy subjects and also in the subjects having insomnia', 'healthy volunteers and insomnia patients']","['Ashwagandha root extract', 'ashwagandha root extract', 'Ashwagandha or placebo', 'placebo']","['parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality', 'sleep parameters', 'insomnia subjects', 'mental alertness', 'sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake', 'sleep efficiency', 'Safety and adverse events', 'sleep quality', 'SOL', 'Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0549164', 'cui_str': 'Mental alertness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",80.0,0.0352543,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","[{'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Langade', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: deepak.langade@dypatil.edu.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Thakare', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: vaishali.thakare@dypatil.edu.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Kanchi', 'Affiliation': 'NAMO Medical Education and Research Institute, Silvassa, DNH&DD, India. Electronic address: rksubodh@gmail.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kelgane', 'Affiliation': 'Maharashtra Emergency Medical Services, Defence Area, Pimple Gurav, Pimpri-Chinchwad, 411027, Maharashtra, India. Electronic address: sunildrkelgane@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113276']
2524,32819529,Impact of Female Sex on Clinical Presentation and Ablation Outcomes in the CIRCA-DOSE Study.,"OBJECTIVES
This study sought to evaluate sex-specific differences in atrial fibrillation (AF) presentation and catheter ablation outcomes in the prospective, multicenter, randomized CIRCA-DOSE (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration) study.
BACKGROUND
Similar to other cardiovascular conditions, significant sex-specific differences have been observed in the epidemiology, pathophysiology, presentation, and natural history of AF. Unfortunately, there are major gaps in our understanding of the pathophysiological basis for the observed sex-specific differences and their implications on therapy and prognosis.
METHODS
This study examined sex-specific differences in AF presentation, symptom severity and health-related quality of life, symptomatic and asymptomatic arrhythmia recurrence, AF burden, and health care utilization.
RESULTS
Freedom from any atrial tachyarrhythmia and symptomatic atrial tachyarrhythmia were similar between male (hazard ratio: 1.18; 95% confidence interval: 0.85 to 1.64; p = 0.39) and female patients (hazard ratio: 1.00; 95% confidence interval: 0.62 to 1.59; p = 0.92). Post-ablation, the median AF burden (percentage time in AF) was 0.00% (interquartile range: 0.00% to 0.16%) in male patients and 0.00% (interquartile range: 0.00% to 0.17%) in female patients, with no difference observed between the sexes (p = 0.30). Periprocedural complications occurred twice as frequently in female patients (3.5% vs. 7.0%; p = 0.18). In comparison to male patients, female patients reported a significantly worse symptom score and quality of life at baseline and all follow-up intervals, but they derived similar magnitude of improvement post-ablation. There was no difference between male and female patients with respect to emergency department visits, hospitalization, cardioversion, or repeat ablation.
CONCLUSIONS
When compared with male patients, female patients have significantly worse symptom scores and quality of life at baseline. Despite this, female patients with symptomatic paroxysmal AF derive similar benefit in freedom from recurrent arrhythmia and similar improvements in quality of life following AF ablation. (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration [CIRCA-DOSE]; NCT01913522).",2020,"There was no difference between male and female patients with respect to emergency department visits, hospitalization, cardioversion, or repeat ablation.
",['female patients with symptomatic paroxysmal AF'],"['Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration [CIRCA-DOSE', 'CIRCA-DOSE (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation']","['quality of life', 'symptom score and quality of life', 'atrial tachyarrhythmia and symptomatic atrial tachyarrhythmia', 'median AF burden', 'emergency department visits, hospitalization, cardioversion, or repeat ablation', 'AF presentation, symptom severity and health-related quality of life, symptomatic and asymptomatic arrhythmia recurrence, AF burden, and health care utilization', 'symptom scores and quality of life', 'Periprocedural complications']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}]","[{'cui': 'C0162561', 'cui_str': 'Radiofrequency Catheter Ablation'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}]",,0.0558922,"There was no difference between male and female patients with respect to emergency department visits, hospitalization, cardioversion, or repeat ablation.
","[{'ForeName': 'Ren Jie Robert', 'Initials': 'RJR', 'LastName': 'Yao', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Data Science Institute, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Nathaniel M', 'Initials': 'NM', 'LastName': 'Hawkins', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sedlak', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Nault', 'Affiliation': 'Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Southlake Regional Health Centre, Newmarket, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada. Electronic address: Jason.andrade@vch.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2020.04.032']
2525,32819740,The Impact of a 20-Minute Animal-Assisted Activity Session on the Physiological and Emotional States in Patients With Fibromyalgia.,"OBJECTIVE
To study the direct physiological and emotional impact of an animal-assisted activity (AAA) session (a form of complementary and integrative medicine) in patients with fibromyalgia (FM).
PATIENTS AND METHODS
The study population consisted of 221 participants with FM who were attending Mayo Clinic's Fibromyalgia Treatment Program between August 5, 2017, and September 1, 2018. This was a randomized controlled trial. Participants were randomly assigned to either the treatment group (a 20-minute session with a certified therapy dog and handler) or the control group (a 20-minute session with a handler only). To gain a better understanding of the direct physiological and emotional effects of AAA in patients with FM, we used multiple noninvasive physiologic-emotional biomarkers, including salivary cortisol and oxytocin concentrations, tympanic membrane temperatures, and various cardiac parameters, in addition to standardized pain and mood-based questionnaires.
RESULTS
Results show a decrease in heart rate, an increase in heart rate variability, an increase in well-being survey scores, an increase in salivary oxytocin, and subsequent tympanic membrane temperature changes, suggesting that participants in the treatment group were in a more positive emotional-physiologic state as a result of the AAA session compared with the control group.
CONCLUSION
Our results suggest that a 20-minute therapy dog visit in an outpatient setting can significantly and positively impact the physical and mental health of patients with FM.",2020,Participants were randomly assigned to either the treatment group (a 20-minute session with a certified therapy dog and handler) or the control group (a 20-minute session with a handler only).,"[""221 participants with FM who were attending Mayo Clinic's Fibromyalgia Treatment Program between August 5, 2017, and September 1, 2018"", 'patients with fibromyalgia (FM', 'Patients With Fibromyalgia', 'patients with FM']","['certified therapy dog and handler) or the control group (a\xa020-minute session with a handler only', '20-Minute Animal-Assisted Activity Session', 'animal-assisted activity (AAA) session (a form of complementary and integrative medicine']","['heart rate', 'salivary oxytocin, and subsequent tympanic membrane temperature changes', 'well-being survey scores', 'positive emotional-physiologic state', 'heart rate variability', 'salivary cortisol and oxytocin concentrations, tympanic membrane temperatures, and various cardiac parameters']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2350258', 'cui_str': 'Integrative Medicine'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0041445', 'cui_str': 'Tympanic membrane structure'}, {'cui': 'C0450031', 'cui_str': 'Temperature change'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",221.0,0.0903234,Participants were randomly assigned to either the treatment group (a 20-minute session with a certified therapy dog and handler) or the control group (a 20-minute session with a handler only).,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'Section of Integrative Medicine and Health, Division of General Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Martin', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Ragen T S', 'Initials': 'RTS', 'LastName': 'McGowan', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Smidt', 'Affiliation': 'Section of Integrative Medicine and Health, Division of General Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Turpin', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Langenfeld-McCoy', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Bauer', 'Affiliation': 'Section of Integrative Medicine and Health, Division of General Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Arya B', 'Initials': 'AB', 'LastName': 'Mohabbat', 'Affiliation': 'Section of Integrative Medicine and Health, Division of General Internal Medicine, Mayo Clinic, Rochester, MN. Electronic address: mohabbat.arya@mayo.edu.'}]",Mayo Clinic proceedings,['10.1016/j.mayocp.2020.04.037']
2526,32816504,Moderators of treatment response to an intervention for nonsuicidal self-injury in young adults.,"Objective: Despite the prevalence and impact of nonsuicidal self-injury (NSSI), there are few treatments developed to treat the behavior specifically, and little is known about moderators of treatment response. The Treatment for Self-Injurious Behaviors (T-SIB), a brief, behavioral intervention, was developed to treat NSSI in young adults; a previous pilot randomized controlled trial (RCT) comparing T-SIB with treatment as usual (TAU) provided support for the intervention. This study examined demographic, clinical, and NSSI-related predictors of treatment outcome in the pilot RCT for T-SIB. Method: Young adults (N = 33) were randomized to receive T-SIB or treatment as usual; all participants were included in intent-to-treat analyses. The primary outcome of NSSI behaviors was assessed at baseline, posttreatment (9 weeks), and 3-month follow up, and potential moderators were assessed at baseline. Results: Greater lifetime and last year NSSI frequency was associated with fewer NSSI behaviors at posttreatment and follow up among participants in T-SIB. Anxious symptoms also moderated treatment outcomes, but other demographic and clinical variables did not. Conclusion: Previous research has shown that T-SIB is more effective than TAU overall; the current study suggests that T-SIB may be effective for individuals with more frequent NSSI and those with elevated anxiety. A larger evaluation of T-SIB is supported. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Greater lifetime and last year NSSI frequency was associated with fewer NSSI behaviors at posttreatment and follow up among participants in T-SIB.,"['Young adults (N = 33', 'young adults', 'nonsuicidal self-injury in young adults']",[],"['Greater lifetime and last year NSSI frequency', 'NSSI behaviors', 'Anxious symptoms']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}]",[],"[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",33.0,0.159824,Greater lifetime and last year NSSI frequency was associated with fewer NSSI behaviors at posttreatment and follow up among participants in T-SIB.,"[{'ForeName': 'Margaret S', 'Initials': 'MS', 'LastName': 'Andover', 'Affiliation': 'Department of Psychology, Fordham University.'}, {'ForeName': 'Heather T', 'Initials': 'HT', 'LastName': 'Schatten', 'Affiliation': 'Psychosocial Research Program, Butler Hospital.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Holman', 'Affiliation': 'Providence Veterans Affairs Medical Center.'}, {'ForeName': 'Ivan W', 'Initials': 'IW', 'LastName': 'Miller', 'Affiliation': 'Psychosocial Research Program, Butler Hospital.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000603']
2527,32816521,A Randomized Controlled Trial Comparing Traditional Plaster Cast Rehabilitation With Functional Walking Boot Rehabilitation for Acute Achilles Tendon Ruptures.,"BACKGROUND
There has been a shift toward functional nonoperative rehabilitation in the treatment of Achilles tendon rupture (ATR) despite a shortage of studies directly comparing nonoperative functional rehabilitation with traditional nonoperative immobilization.
PURPOSE
To compare patient-reported outcome measures and functional outcomes for nonoperatively treated ATR with traditional cast immobilization or functional rehabilitation in a walking boot.
STUDY DESIGN
Randomized controlled clinical trial; Level of evidence, 2.
METHODS
In a single-center nonblinded study, 140 patients were randomized to compare treatment for acute ATR in (1) an immobilizing cast in reducing degrees of equinus over a 10-week period with 8 weeks of nonweightbearing mobilization or (2) a walking boot for 8 weeks with reducing equinus and immediate full weightbearing. Exclusion criteria were delayed presentation >2 weeks after injury, tendon reruptures, and latex allergy. Analysis was undertaken on an intention-to-treat basis.
RESULTS
A total of 69 patients (median age, 41 years [interquartile range, 33-50.5 years]) were randomized to walking boot treatment and 71 patients (41 [32-49]) to cast treatment. At 6 months, patients treated in a walking boot reported better Short Musculoskeletal Function Assessment (SMFA) dysfunction index (6.62 [2.21-12.50] vs 10.66 [4.96-13.42]; P = .050), SMFA bother index (7.29 [2.08-14.58] vs 10.42 [5.73-19.27]; P = .04), Achilles Tendon Total Rupture Score (71.5 [53.50-84.25] vs 54.0 [37-76]; P = .01), and Foot and Ankle Questionnaire core score (91 [81.89-97.55] vs 85 [78.25-92.09]; P = .04). At 1 year, there was no difference in SMFA dysfunction index (2.21 [0.74-5.88] vs 2.94 [1.47-6.62]; P = .25), SMFA bother index (2.08 [0-9.38] vs 5.21 [0.52-11.98]; P = .25), Achilles Tendon Total Rupture Score (92 [72.50-96] vs 87.5 [66.0-94.75]; P = .21), or Foot and Ankle Questionnaire core score (97.75 [89.46-99.00] vs 95.50 [90.88-97.50]; P = .18). Rerupture occurred in 5 and 11 patients ( P = .075) and venous thromboembolism in 2 and 3 patients ( P = .67) in the boot and cast groups, respectively. Fifteen patients in the boot group but none in the cast group had skin problems ( P < .001). Patients treated in a boot returned to driving at a median 12 weeks (vs 13 weeks for cast; P = .045), but there was no difference in time to return to work ( P = .48).
CONCLUSION
Functional rehabilitation with early weightbearing is a safe alternative to traditional immobilizing treatment for ATR, giving better early functional outcomes, albeit with a higher incidence of transient minor skin complications.
REGISTRATION
NCT02598843 (ClinicalTrials.gov identifier).",2020,"Rerupture occurred in 5 and 11 patients ( P = .075) and venous thromboembolism in 2 and 3 patients ( P = .67) in the boot and cast groups, respectively.","['69 patients (median age, 41 years [interquartile range, 33-50.5 years', '140 patients', 'Acute Achilles Tendon Ruptures', 'Achilles tendon rupture (ATR']","['traditional cast immobilization or functional rehabilitation', 'Traditional Plaster Cast Rehabilitation With Functional Walking Boot Rehabilitation', 'immobilizing cast in reducing degrees of equinus over a 10-week period with 8 weeks of nonweightbearing mobilization or (2) a walking boot for 8 weeks with reducing equinus and immediate full weightbearing', 'walking boot treatment']","['Short Musculoskeletal Function Assessment (SMFA) dysfunction index', 'Rerupture', 'SMFA dysfunction index', 'skin problems', 'SMFA bother index', 'venous thromboembolism', 'Foot and Ankle Questionnaire core score', 'Achilles Tendon Total Rupture Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0454532', 'cui_str': 'Functional rehabilitation'}, {'cui': 'C0032159', 'cui_str': 'Plaster cast'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1318107', 'cui_str': 'Load-Bearing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0026861', 'cui_str': 'Musculoskeletal function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0281822', 'cui_str': 'Skin problem'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}]",140.0,0.180691,"Rerupture occurred in 5 and 11 patients ( P = .075) and venous thromboembolism in 2 and 3 patients ( P = .67) in the boot and cast groups, respectively.","[{'ForeName': 'Julian F', 'Initials': 'JF', 'LastName': 'Maempel', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Nick D', 'Initials': 'ND', 'LastName': 'Clement', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Duckworth', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Oisin J F', 'Initials': 'OJF', 'LastName': 'Keenan', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Tim O', 'Initials': 'TO', 'LastName': 'White', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Leela C', 'Initials': 'LC', 'LastName': 'Biant', 'Affiliation': 'University of Manchester Medical School, Manchester, UK.'}]",The American journal of sports medicine,['10.1177/0363546520944905']
2528,32825565,The Prototypes of Tobacco Users Scale (POTUS) for Cigarette Smoking and E-Cigarette Use: Development and Validation.,"Endorsing prototypes of cigarette smokers predicts cigarette smoking, but less is known about prototypes of users of other tobacco products. Our study sought to establish the reliability and validity of a measure of prototypes of smokers and e-cigarette users. Participants were from a national survey of smokers and non-smokers ( n = 1414), a randomized clinical trial (RCT) of adult smokers ( n = 2149), and adolescent children of adults in the trial ( n = 112). The Prototypes of Tobacco Users Scale (POTUS) has four positive adjectives (cool, sexy, smart, and healthy) and four negative adjectives (disgusting, unattractive, immature, and inconsiderate) describing cigarette smokers and e-cigarette users. Confirmatory factor analyses identified a two-factor solution. The POTUS demonstrated strong internal consistency reliability in all three samples (median α = 0.85) and good test-retest reliability among adults in the RCT (median r = 0.61, 1-4 weeks follow-up). In the RCT, smokers more often agreed with negative prototypes for smokers than for e-cigarette users (mean = 2.03 vs. 1.67, p < 0.05); negative prototypes at baseline were also associated with more forgoing of cigarettes and making a quit attempt at the end of the trial (Week 4 follow-up). The POTUS may be useful to public health researchers seeking to design interventions that reduce tobacco initiation or cessation through the manipulation of tobacco user prototypes.",2020,"The POTUS demonstrated strong internal consistency reliability in all three samples (median α = 0.85) and good test-retest reliability among adults in the RCT (median r = 0.61, 1-4 weeks follow-up).","['smokers and e-cigarette users', 'Participants were from a national survey of smokers and non-smokers ( n = 1414), a randomized clinical trial (RCT) of adult smokers ( n = 2149), and adolescent children of adults in the trial ( n = 112']",[],['internal consistency reliability'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4505216', 'cui_str': 'Electronic cigarette user'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319548', 'cui_str': '112'}]",[],"[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",,0.0224771,"The POTUS demonstrated strong internal consistency reliability in all three samples (median α = 0.85) and good test-retest reliability among adults in the RCT (median r = 0.61, 1-4 weeks follow-up).","[{'ForeName': 'Eboneé N', 'Initials': 'EN', 'LastName': 'Butler', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599 USA.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Lineberger Comprehensive Cancer Center, Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'May S', 'Initials': 'MS', 'LastName': 'Chen', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Pepper', 'Affiliation': 'RTI International, Research Triangle Park, NC 27709, USA.'}, {'ForeName': 'Hart', 'Initials': 'H', 'LastName': 'Blanton', 'Affiliation': 'Department of Communication, Texas A&M University, College Station, TX 77843, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Lineberger Comprehensive Cancer Center, Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17176081']
2529,32825677,A Comparison of the Acute Effects of Different Forms of Yoga on Physiological and Psychological Stress: A Pilot Study.,"Yoga is a frequently recommended stress management strategy; however, the acute stress response to varying types of yoga are not fully clear. Thus, the purpose of this study was to compare the acute effects of meditative and power yoga on indices of physiological and psychological stress. In a crossover counterbalanced design, physically active females (n = 13; age = 20.8 yrs ± 0.8, height = 164.5 cm ± 6.1, body mass = 65.0 kg ± 13.8) who did not regularly participate in yoga or mindful training enrolled in this study. Participants completed two visits each, with a standardized instructional-video 30-min yoga session with either A) meditative (Hatha style) yoga or B) power (Vinyasa style) yoga. Prior to and immediately after each yoga bout, psychological stress was assessed using the State-Trait Anxiety Inventory (STAI) questionnaire, and salivary cortisol samples were obtained to measure indices of physiological stress. State anxiety scores were significantly lower following meditative yoga ( p = 0.047) but were not different following power yoga ( p = 0.625). Salivary cortisol levels were significantly lower following meditative yoga ( p = 0.020) but not following power yoga ( p = 0.242). Results indicate that acute engagement in meditative yoga decreases markers of psychological and physiological stress, while power yoga does not impart a significant stress-relieving benefit. Findings indicate that differing types of yoga may have various stress-relieving capabilities and should be considered by individuals seeking anxiolytic benefits.",2020,State anxiety scores were significantly lower following meditative yoga ( p = 0.047) but were not different following power yoga ( p = 0.625).,"['physically active females (n = 13; age = 20.8 yrs ± 0.8, height = 164.5 cm ± 6.1, body mass = 65.0 kg ± 13.8) who did not regularly participate in yoga or mindful training enrolled in this study']","['meditative and power yoga', 'standardized instructional-video 30-min yoga session with either A) meditative (Hatha style) yoga or B) power (Vinyasa style) yoga']","['State-Trait Anxiety Inventory (STAI) questionnaire, and salivary cortisol samples', 'Salivary cortisol levels', 'State anxiety scores', 'psychological and physiological stress']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}]",13.0,0.0164619,State anxiety scores were significantly lower following meditative yoga ( p = 0.047) but were not different following power yoga ( p = 0.625).,"[{'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Marshall', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, AL 35229, USA.'}, {'ForeName': 'McKenzie', 'Initials': 'M', 'LastName': 'McClanahan', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, AL 35229, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McArthur Warren', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, AL 35229, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Rogers', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, AL 35229, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ballmann', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, AL 35229, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17176090']
2530,32822286,"MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum.","PURPOSE
Low-grade serous ovarian carcinomas (LGSOCs) have historically low chemotherapy responses. Alterations affecting the MAPK pathway, most commonly KRAS/BRAF, are present in 30%-60% of LGSOCs. The purpose of this study was to evaluate binimetinib, a potent MEK1/2 inhibitor with demonstrated activity across multiple cancers, in LGSOC.
METHODS
This was a 2:1 randomized study of binimetinib (45 mg twice daily) versus physician's choice chemotherapy (PCC). Eligible patients had recurrent measurable LGSOC after ≥ 1 prior platinum-based chemotherapy but ≤ 3 prior chemotherapy lines. The primary end point was progression-free survival (PFS) by blinded independent central review (BICR); additional assessments included overall survival (OS), overall response rate (ORR), duration of response (DOR), clinical-benefit rate, biomarkers, and safety.
RESULTS
A total of 303 patients were randomly assigned to an arm of the study at the time of interim analysis (January 20, 2016). Median PFS by BICR was 9.1 months (95% CI, 7.3 to 11.3) for binimetinib and 10.6 months (95% CI, 9.2 to 14.5) for PCC (hazard ratio,1.21; 95%CI, 0.79 to 1.86), resulting in early study closure according to a prespecified futility boundary after 341 patients had enrolled. Secondary efficacy end points were similar in the two groups: ORR 16% (complete response [CR]/partial responses[PRs], 32) versus 13% (CR/PRs, 13); median DOR, 8.1 months (range, 0.03 to ≥ 12.0 months) versus 6.7 months (0.03 to ≥ 9.7 months); and median OS, 25.3 versus 20.8 months for binimetinib and PCC, respectively. Safety results were consistent with the known safety profile of binimetinib; the most common grade ≥ 3 event was increased blood creatine kinase level (26%). Post hoc analysis suggests a possible association between KRAS mutation and response to binimetinib. Results from an updated analysis (n = 341; January 2019) were consistent.
CONCLUSION
Although the MEK Inhibitor in Low-Grade Serous Ovarian Cancer Study did not meet its primary end point, binimetinib showed activity in LGSOC across the efficacy end points evaluated. A higher response to chemotherapy than expected was observed and KRAS mutation might predict response to binimetinib.",2020,"Median PFS by BICR was 9.1 months (95% CI, 7.3 to 11.3) for binimetinib and 10.6 months (95% CI, 9.2 to 14.5) for PCC (hazard ratio,1.21; 95%CI, 0.79 to 1.86), resulting in early study closure according to a prespecified futility boundary after 341 patients had enrolled.","['Eligible patients had recurrent measurable LGSOC after ≥ 1 prior platinum-based chemotherapy but ≤ 3 prior chemotherapy lines', '341 patients had enrolled', '303 patients']","[""Binimetinib Versus Physician's Choice Chemotherapy"", ""binimetinib (45 mg twice daily) versus physician's choice chemotherapy (PCC""]","['progression-free survival (PFS) by blinded independent central review (BICR); additional assessments included overall survival (OS), overall response rate (ORR), duration of response (DOR), clinical-benefit rate, biomarkers, and safety', 'blood creatine kinase level', 'Median PFS by BICR']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3899947', 'cui_str': 'Binimetinib'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0853178', 'cui_str': 'Blood creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",303.0,0.201088,"Median PFS by BICR was 9.1 months (95% CI, 7.3 to 11.3) for binimetinib and 10.6 months (95% CI, 9.2 to 14.5) for PCC (hazard ratio,1.21; 95%CI, 0.79 to 1.86), resulting in early study closure according to a prespecified futility boundary after 341 patients had enrolled.","[{'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ.'}, {'ForeName': 'Rachel N', 'Initials': 'RN', 'LastName': 'Grisham', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Weill Cornell Medical Center, New York, NY.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Royal Marsden National Health Service Foundation Trust and Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Kalbacher', 'Affiliation': 'Centre Hospitalier Régional et Universitaire de Besançon, CHRU de Besançon, Besançon, France.'}, {'ForeName': 'Mansoor Raza', 'Initials': 'MR', 'LastName': 'Mirza', 'Affiliation': 'Nordic Society of Gynaecological Oncology and Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Romero', 'Affiliation': 'Servicio de Oncologıa Medica, Fundacion Instituto Valenciano de Oncologıa, Valencia, Spain.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vuylsteke', 'Affiliation': 'CHU Université catholique de Louvain Namur, Sainte-Elisabeth, Namur, Belgium.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Hilpert', 'Affiliation': 'Onkologisches Therapiezentrum am Krankenhaus Jerusalem, Hamburg, Germany.'}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'Westermann', 'Affiliation': 'Dutch Gynaecological Oncology Group, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Martin K', 'Initials': 'MK', 'LastName': 'Oehler', 'Affiliation': 'Department of Gynaecological Oncology, Royal Adelaide Hospital, Adelaide, South Australia 5005, Australia.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Pignata', 'Affiliation': 'Istituto Nazionale Tumori Fondazione Pascale IRCCS, Naples, Italy.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Dipartimento Medicina e Chirurgia, Università Milano-Bicocca, Programma Ginecologia Oncologica Istituto Europeo Oncologia, IRCCS, Milan, Italy.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Drill', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Weill Cornell Medical Center, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cibula', 'Affiliation': 'First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Kathleen N', 'Initials': 'KN', 'LastName': 'Moore', 'Affiliation': 'Stephenson Cancer Center at The University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Janna', 'Initials': 'J', 'LastName': 'Christy-Bittel', 'Affiliation': 'Pfizer, New York, NY.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Del Campo', 'Affiliation': ""Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Berger', 'Affiliation': 'University Clinic for Gynaecology and Obstetrics, Medical University of Innsbruck, Innsbruck 6020, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Marth', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Innsbruck, Austrian AGO, Innsbruck, Austria.'}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Center for Oncological Surgery, European Competence Center for Ovarian Cancer Campus Virchow Klinikum and Benjamin Franklin Charité Comprehensive Cancer Center\u2009, Medical University of Berlin, Berlin, Germany.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Churruca', 'Affiliation': 'Biodonostia HRI, Osasun Ikerketa Insitutua, Insituto de Investigacion Sanitaria, San Sebastián, Gipuzkoa, Spain.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Boyd', 'Affiliation': 'Pfizer, New York, NY.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Kristensen', 'Affiliation': 'Department for Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clamp', 'Affiliation': 'Department of Medical Oncology, The Christie National Health Service Foundation Trust, and University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'Centre Léon Bérard, Netsarc Network, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'Belgium and Luxemburg Gynaecological Oncology Group, University Hospitals Leuven, Leuven, Belgium.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01164']
2531,32738409,Acute effects of adaptive Deep Brain Stimulation in Parkinson's disease.,"BACKGROUND
Beta-based adaptive Deep Brain Stimulation (aDBS) is effective in Parkinson's disease (PD), when assessed in the immediate post-implantation phase. However, the potential benefits of aDBS in patients with electrodes chronically implanted, in whom changes due to the microlesion effect have disappeared, are yet to be assessed.
METHODS
To determine the acute effectiveness and side-effect profile of aDBS in PD compared to conventional continuous DBS (cDBS) and no stimulation (NoStim), years after DBS implantation, 13 PD patients undergoing battery replacement were pseudo-randomised in a crossover fashion, into three conditions (NoStim, aDBS or cDBS), with a 2-min interval between them. Patient videos were blindly evaluated using a short version of the Unified Parkinson's Disease Rating Scale (subUPDRS), and the Speech Intelligibility Test (SIT).
RESULTS
Mean disease duration was 16 years, and the mean time since DBS-implantation was 6.9 years. subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p = .001), when compared to NoStim. Bradykinesia subscores were significantly lower in aDBS (p = .002), and did not achieve significance during cDBS (p = .08), when compared to NoStim. Two patients demonstrated re-emerging tremor during aDBS. SIT scores of patients who presented stimulation-induced dysarthria significantly worsened in cDBS (p = .009), but not in aDBS (p = .407), when compared to NoStim. Overall, stimulation was applied 48.8% of the time during aDBS.
CONCLUSION
Beta-based aDBS is effective in PD patients with bradykinetic phenotypes, delivers less stimulation than cDBS, and potentially has a more favourable speech side-effect profile. Patients with prominent tremor may require a modified adaptive strategy.",2020,"subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p=.001), when compared to NoStim.","[""Parkinson's disease"", 'PD patients with bradykinetic phenotypes', '13 PD patients undergoing battery replacement', 'Patients with prominent tremor', ""Parkinson's disease (PD""]","['aDBS', 'Adaptive Deep Brain Stimulation', 'Beta-based aDBS', 'Beta-based adaptive Deep Brain Stimulation (aDBS', 'conventional continuous DBS (cDBS) and no stimulation (NoStim), years after DBS implantation']","['Mean disease duration', 'subUPDRS scores', 'SIT scores', ""Unified Parkinson's Disease Rating Scale (subUPDRS), and the Speech Intelligibility Test (SIT"", 'mean time since DBS-implantation', 'Bradykinesia subscores']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0445093', 'cui_str': 'No stimulation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}]",,0.0348207,"subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p=.001), when compared to NoStim.","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Piña-Fuentes', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands; Medical Research Council Brain Network Dynamics Unit at the University of Oxford, United Kingdom; Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom; Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'J Marc C', 'Initials': 'JMC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'van Zijl', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'Harmen R', 'Initials': 'HR', 'LastName': 'Moes', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'Teus', 'Initials': 'T', 'LastName': 'van Laar', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'D L Marinus', 'Initials': 'DLM', 'LastName': 'Oterdoom', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Little', 'Affiliation': 'Department of Movement Disorders and Neuromodulation, University of California San Francisco, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Medical Research Council Brain Network Dynamics Unit at the University of Oxford, United Kingdom; Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Beudel', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans. Electronic address: m.beudel@amsterdamumc.nl.'}]",Brain stimulation,['10.1016/j.brs.2020.07.016']
2532,32738416,"Afatinib in patients with advanced non-small cell lung cancer harboring HER2 mutations, previously treated with chemotherapy: A phase II trial.","BACKGROUND
Despite 1-4 % of NSCLC tumors harboring mutations in the HER2 gene, there are no approved HER2-pathway-targeted treatments available. We report an open-label, single-arm, multicenter phase II study investigating the efficacy and safety of afatinib in Asian patients with HER2-mutation positive (HER2m+) NSCLC.
METHODS
Eligible patients for Part A had confirmed stage IIIb/IV HER2m + NSCLC, had failed one or two prior lines of chemotherapy, and were EGFR/HER2-inhibitor naïve. Patients received oral afatinib 40 mg/day in continuous 28-day cycles, until disease progression or intolerable adverse events (AEs). Patients qualified for Part B if they had > 12 weeks' clinical benefit and Eastern Cooperative Oncology Group performance status ≤ 2. In Part B, patients were to receive afatinib at the last received dose, plus paclitaxel 80 mg/m 2 weekly, until disease progression or intolerable AEs. The primary endpoint in Part A was objective response (OR); secondary endpoints included disease control (DC), progression-free survival (PFS), and overall survival (OS). Further exploratory endpoints were OR, DC, and PFS in Part B.
RESULTS
Eighteen patients received afatinib in Part A. No patient achieved an OR; 11 patients (61.1 %) achieved stable disease, and six patients (33.3 %) had progressive disease. DC rate was therefore 61.1 % (95 % confidence interval [CI]: 35.7, 82.7). A decrease in tumor size from baseline of > 0 to < 30 % was observed in eight patients. At the time of analysis, 16 patients (88.9 %) had progressed or died. Median PFS was 2.76 months (95 % CI: 1.87, 4.60) and median OS was 10.02 months (95 % CI: 8.47, 10.08). All patients experienced ≥ 1 AE, most commonly diarrhea (66.7 %) and rash (33.3 %). No patients met the inclusion criteria for Part B, and recruitment was slow; therefore, the study was terminated.
CONCLUSIONS
This study found no clinical benefit of afatinib for EGFR TKI-naïve patients with HER2m + NSCLC.",2020,"Median PFS was 2.76 months (95 % CI: 1.87, 4.60) and median OS was 10.02 months (95 % CI: 8.47, 10.08).","['Eighteen patients received afatinib in Part A', ""Patients qualified for Part B if they had > 12 weeks' clinical benefit and Eastern Cooperative Oncology Group performance status ≤ 2"", 'EGFR TKI-naïve patients with HER2m\u202f+\u202fNSCLC', 'Asian patients with HER2-mutation positive (HER2m+) NSCLC', 'Eligible patients for Part A had confirmed stage IIIb/IV HER2m', 'patients with advanced non-small cell lung cancer harboring HER2 mutations']","['Afatinib', 'oral afatinib', 'plus paclitaxel 80\u202fmg/m 2 weekly, until disease progression or intolerable AEs', 'chemotherapy', 'afatinib']","['OR, DC, and PFS in Part B', 'diarrhea', 'DC rate', 'progressive disease', 'Median PFS', 'median OS', 'objective response (OR); secondary endpoints included disease control (DC), progression-free survival (PFS), and overall survival (OS', 'progressed or died', 'efficacy and safety', 'tumor size', 'stable disease', 'rash']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}]","[{'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",,0.160329,"Median PFS was 2.76 months (95 % CI: 1.87, 4.60) and median OS was 10.02 months (95 % CI: 8.47, 10.08).","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Chengzhi', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, Guangdong, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'The First Affiliated Hospital with Nanjing Medical University, Jiangsu, China.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China.'}, {'ForeName': 'Hairui', 'Initials': 'H', 'LastName': 'Hua', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China.'}, {'ForeName': 'Dennis Chin-Lun', 'Initials': 'DC', 'LastName': 'Huang', 'Affiliation': 'Boehringer Ingelheim Taiwan Limited, Taipei, Taiwan.'}, {'ForeName': 'Caicun', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Medical Oncology, Shanghai Pulmonary Hospital, Shanghai, China. Electronic address: caicunzhoudr@163.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.07.017']
2533,32740306,Integration of Person-Centered Narratives Into the Electronic Health Record: Study Protocol.,"BACKGROUND
Incorporating a patient's personal narrative into the electronic health record is an opportunity to more fully integrate the patient's values and beliefs into care, thus creating opportunities to deliver high-quality/high-value, person-centered care.
OBJECTIVES
The aim of the study was to present a study protocol of a narrative intervention to (a) compare the effects of the narrative intervention to usual care on primary outcome of person's (patient) perceptions of quality of communication, (b) compare the effects of the narrative intervention on secondary outcomes of biopsychosocial well-being, and (c) examine the feasibility and acceptability of the narrative intervention from the perspective of both persons: the patient and the acute care bedside nurse.
METHODS
A randomized control trial is being conducted with a targeted enrollment of 80 patient participants and 80 nurse participants. The patient participants include individuals who are admitted to the acute care hospital for either heart failure or end-stage renal disease. An acute care beside nurse who has cared for the patient participant is also enrolled. Through a 1:1 random allocation scheme, stratified by illness, we will enroll 40 in the narrative intervention group and 40 in the usual care group. Patient participants will be assessed for patient-reported outcomes of patient's perception of quality of communication and biopsychosocial well-being.
RESULTS
The study began in October 2019; 53 potential patient participants have been approached, 21 have enrolled, and 20 have completed the data collection process.
DISCUSSION
The testing and integration of a person-centered narrative into the electronic health record is a novel approach to provide opportunities for improvement in communication between patients and nurses. The results from this study will provide important preliminary knowledge to inform future randomized clinical trials of narrative interventions leading to advances in how to best provide high-value, high-quality, person-centered care for persons living with serious illness.",2020,The testing and integration of a person-centered narrative into the EHR is a novel approach to provide opportunities for improvement in communication between patients and nurses.,"['80 patient participants and 80 nurse participants', 'October 2019; 53 potential patient participants have been approached, 21 have enrolled, and 20 have completed the data collection process', 'patient participants include individuals who are admitted to the acute care hospital for either heart failure or end-stage renal disease', 'persons living with serious illness']","['narrative intervention', 'narrative intervention to usual care']","['feasibility and acceptability', ""patient's perception of quality of communication and biopsychosocial well-being""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0644748,The testing and integration of a person-centered narrative into the EHR is a novel approach to provide opportunities for improvement in communication between patients and nurses.,"[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Coats', 'Affiliation': 'Heather Coats, PhD, APRN-BC, is Assistant Professor of Research, College of Nursing, University of Colorado Anschutz Medical Campus, Aurora. Nadia Shive, BA, CCRC, is Professional Research Assistant, College of Nursing, University of Colorado Anschutz Medical Campus, Aurora. Ardith Z. Doorenbos, PhD, RN, FAAN, is Nursing Collegiate Professor, College of Nursing, University of Illinois at Chicago, and Director of Palliative Care and Co-leader of Cancer Prevention and Control Program, University of Illinois Cancer Center, Chicago. Sarah Schmiege, PhD, is Biostatistician, Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Shive', 'Affiliation': ''}, {'ForeName': 'Ardith Z', 'Initials': 'AZ', 'LastName': 'Doorenbos', 'Affiliation': ''}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Schmiege', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000463']
2534,32748630,Effects of transcranial magnetic stimulation on the performance of the activities of daily living and attention function after stroke: a randomized controlled trial.,"OBJECTIVE
We aimed to interrogate the effects of transcranial magnetic stimulation (TMS) on the performance in activities of daily living (ADL) and attention function after stroke.
DESIGN
Randomized controlled trial.
SETTING
Inpatient rehabilitation hospital.
SUBJECTS
We randomized 62 stroke patients with attention dysfunction who were randomly assigned into two groups, and two dropped out from each group. The TMS group ( n = 29) and a sham group ( n = 29), whose mean (SD) was 58.12 (6.72) years. A total of 33 (56.9%) patients had right hemisphere lesion while the rest 25 (43.1%) patients had left hemisphere lesion.
INTERVENTIONS
Patients in the TMS group received 10 Hz, 700 pulses of TMS, while those in the sham group received sham TMS for four weeks. All the participants underwent comprehensive cognitive training.
MAIN MEASURES
At baseline, and end of the four-week treatment, the performance in the activities of daily living was assessed by Functional Independence Measure (FIM). On the other side, attention dysfunction was screened by Mini-Mental State Examination (MMSE), while the attention function was assessed by the Trail Making Test-A (TMT-A), Digit Symbol Test (DST) and Digital Span Test (DS).
RESULTS
Our data showed a significant difference in the post-treatment gains in motor of Functional Independence Measure (13.00 SD 1.69 vs 4.21 SD 2.96), cognition of Functional Independence Measure (4.69 SD 1.56 vs 1.52 SD 1.02), total of Functional Independence Measure (17.69 SD 2.36 vs 5.72 SD 3.12), Mini-Mental State Examination (3.07 SD 1.36 vs 1.21 SD 0.62), time taken in Trail Making Test-A (96.67 SD 25.18 vs 44.28 SD 19.45), errors number in Trail Making Test-A (2.72 SD 1.03 vs 0.86 SD 1.03), Digit Symbol Test (3.76 SD 1.09 vs 0.76 SD 0.87) or Digital Span Test (1.69 SD 0.54 vs 0.90 SD 0.72) between the TMS group and the sham group ( P < 0.05).
CONCLUSIONS
Taken together, we demonstrate that TMS improves the performance in the activities of daily living and attention function in patients with stroke.",2020,"Taken together, we demonstrate that TMS improves the performance in the activities of daily living and attention function in patients with stroke.","['Inpatient rehabilitation hospital', '62 stroke patients with attention dysfunction', 'after stroke', 'patients with stroke']","['TMS', 'comprehensive cognitive training', 'sham TMS', 'TMS group received 10\u2009Hz, 700 pulses of TMS', 'transcranial magnetic stimulation', 'transcranial magnetic stimulation (TMS']","['Trail Making Test-A (TMT-A), Digit Symbol Test (DST) and Digital Span Test (DS', 'cognition of Functional Independence Measure', 'activities of daily living and attention function', 'performance of the activities of daily living and attention function', 'errors number in Trail Making Test-A', 'performance in the activities of daily living', 'Mini-Mental State Examination', 'motor of Functional Independence Measure', 'Digit Symbol Test', 'Digital Span Test', 'activities of daily living (ADL) and attention function', 'Functional Independence Measure (FIM', 'right hemisphere lesion', 'total of Functional Independence Measure']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0228175', 'cui_str': 'Right cerebral hemisphere structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",62.0,0.395348,"Taken together, we demonstrate that TMS improves the performance in the activities of daily living and attention function in patients with stroke.","[{'ForeName': 'Yuanwen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Mingyu', 'Initials': 'M', 'LastName': 'Yin', 'Affiliation': 'Department of Rehabilitation Medicine, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Rehabilitation Medicine, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Rehabilitation Medicine, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Shuxian', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Cuihuan', 'Initials': 'C', 'LastName': 'Pan', 'Affiliation': 'Department of Rehabilitation Medicine, the Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Xiquan', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Rehabilitation Medicine, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}]",Clinical rehabilitation,['10.1177/0269215520946386']
2535,32750572,Clinical outcomes from the texting for relapse prevention (T4RP) in schizophrenia and schizoaffective disorder study.,"This 6 month randomized control trial investigated whether a novel text-messaging program impacted targeted clinical outcomes in patients with schizophrenia and schizoaffective disorder (SAD). Forty patients were enrolled and completed baseline, 3-month and 6-month assessments. The intervention group received daily symptom check-in text messages, plus, a medication reminder or, inspirational quote text. The control group had treatment as usual. At 6 months the Positive and Negative Syndrome Scale mean positive score was significantly lower and injectable medication compliance was significantly higher in the intervention group. Recovery scores were significantly higher at 3 months. Results suggest that this program may benefit individuals with schizophrenia/SAD who use text messaging. Further investigation in a larger sample appears warranted.",2020,At 6 months the Positive and Negative Syndrome Scale mean positive score was significantly lower and injectable medication compliance was significantly higher in the intervention group.,"['patients with schizophrenia and schizoaffective disorder (SAD', 'Forty patients were enrolled and completed baseline, 3-month and 6-month assessments']","['texting for relapse prevention (T4RP', 'daily symptom check-in text messages, plus, a medication reminder or, inspirational quote text', 'novel text-messaging program']","['Recovery scores', 'injectable medication compliance', 'Positive and Negative Syndrome Scale mean positive score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",40.0,0.0323144,At 6 months the Positive and Negative Syndrome Scale mean positive score was significantly lower and injectable medication compliance was significantly higher in the intervention group.,"[{'ForeName': 'Bernadette A', 'Initials': 'BA', 'LastName': 'Cullen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA; Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA. Electronic address: bcullen@jhmi.edu.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Eaton', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Mojtabai', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA; Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Von Mach', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, USA.""}, {'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Ybarra', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Center for Innovative Public Health Research, San Clemente, California, USA.'}]",Psychiatry research,['10.1016/j.psychres.2020.113346']
2536,32752228,Benefits of Brief Group Cognitive Behavioral Therapy in Reducing Diabetes-Related Distress and HbA1c in Uncontrolled Type 2 Diabetes Mellitus Patients in Thailand.,"This study evaluated the short-term efficacy of brief group cognitive behavioral therapy (BG-CBT) in reducing diabetes-related distress (DRD), lowering hemoglobin A1c (HbA1c), improving food consumption behavior, increasing physical activity, and improving medication adherence behavior. A quasi-experimental pretest/post-test design with follow-up assessments was used with an experimental and a control group. Participants were patients with uncontrolled type 2 diabetes mellitus (T2DM) and moderate or high diabetes-related distress recruited from the Diabetes Mellitus Clinic of Hang Dong Hospital, Chiang Mai, Thailand. Fifty-six eligible participants were purposively selected and enrolled, then randomly assigned to either the BG-CBT group or the control group. The BG-CBT group received six brief weekly sessions of cognitive behavioral group therapy, while the control group received conventional care. Baseline data were collected at week 0 (pretest) and at week 6 (post-test), including food consumption behavior, physical activity, and adherence to medication regimes, as well as a blood examination to determine levels of HbA1c at the week 12 follow-up. DRD was assessed using the Diabetes Distress Scale (DDS-17) and analyzed using descriptive statistics, including pair t-test and independence t-test results. The BG-CBT had a significant effect on the amelioration of diabetes distress, improvement of food consumption behavior, and reduction of HbA1c levels, demonstrating the effectiveness of BG-CBT in maintaining diabetes control in people with T2DM-related distress.",2020,"The BG-CBT had a significant effect on the amelioration of diabetes distress, improvement of food consumption behavior, and reduction of HbA1c levels, demonstrating the effectiveness of BG-CBT in maintaining diabetes control in people with T2DM-related distress.","['Participants were patients with uncontrolled type 2 diabetes mellitus (T2DM) and moderate or high diabetes-related distress recruited from the Diabetes Mellitus Clinic of Hang Dong Hospital, Chiang Mai, Thailand', 'Uncontrolled Type 2 Diabetes Mellitus Patients in Thailand', 'Fifty-six eligible participants']","['brief group cognitive behavioral therapy (BG-CBT', 'cognitive behavioral group therapy, while the control group received conventional care', 'BG-CBT', 'Brief Group Cognitive Behavioral Therapy']","['diabetes-related distress (DRD), lowering hemoglobin A1c (HbA1c), improving food consumption behavior, increasing physical activity, and improving medication adherence behavior', 'Diabetes Distress Scale (DDS-17', 'DRD', 'amelioration of diabetes distress, improvement of food consumption behavior, and reduction of HbA1c levels', 'food consumption behavior, physical activity, and adherence to medication regimes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0544691', 'cui_str': 'Hanging'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026914', 'cui_str': 'Mycobacterium avium-intracellulare'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0010980', 'cui_str': 'Dapsone'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",56.0,0.0198252,"The BG-CBT had a significant effect on the amelioration of diabetes distress, improvement of food consumption behavior, and reduction of HbA1c levels, demonstrating the effectiveness of BG-CBT in maintaining diabetes control in people with T2DM-related distress.","[{'ForeName': 'Kongprai', 'Initials': 'K', 'LastName': 'Tunsuchart', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Peerasak', 'Initials': 'P', 'LastName': 'Lerttrakarnnon', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Kriengkrai', 'Initials': 'K', 'LastName': 'Srithanaviboonchai', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Surinporn', 'Initials': 'S', 'LastName': 'Likhitsathian', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Sombat', 'Initials': 'S', 'LastName': 'Skulphan', 'Affiliation': 'Department of Psychiatric Nursing, Faculty of Nursing, Chiang Mai University, Chiang Mai 50200, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph17155564']
2537,32752234,The Effectiveness of Individual or Group Physiotherapy in the Management of Sub-Acromial Impingement: A Randomised Controlled Trial and Health Economic Analysis.,"Background : Shoulder pain is common in primary care. The management of subacromial impingement (SAI) can include corticosteroid injections and physiotherapy. Physiotherapy can be on an individual or group basis. Aim : To examine the clinical effectiveness and make an economic analysis of individual versus group physiotherapy, following corticosteroid injection for SAI. Design and Setting : A single-blind, open-label, randomised equivalence study comparing group and individual physiotherapy. Patients referred by local general practitioners and physiotherapists were considered for inclusion. Method : Patients were randomised to individual or group physiotherapy groups, and all received corticosteroid injection before physiotherapy. The primary outcome measure was shoulder pain and disability index (SPADI) at 26 weeks. An economic analysis was conducted. Results and Conclusion : 136 patients were recruited, 68 randomised to each group. Recruitment was 68% of the target 200 participants. SPADI (from baseline to 26 weeks) demonstrated a difference (SE) in mean change between groups of -0.43 (5.7) ( p -value = 0.050001), and the TOST (two-one-sided test for equivalence) 90% CI for this difference was (-10.0 to 9.14). This was borderline. In a secondary analysis using inputted data, patients without SPADI at week 26 were analysed by carrying forward scores at week 12 (mean difference (95% CI) = -0.14 (-7.5 to 7.3), p -value = 0.014). There is little difference in outcome at 26 weeks. Group physiotherapy was cheaper to deliver per patient (£252 versus £84). Group physiotherapy for SAI produces similar clinical outcomes to individual physiotherapy with potential cost savings. Due to low recruitment to our study, firm conclusions are difficult and further research is required to give a definitive answer to this research question. (NCT Clinical Trial Registration Number NCT04058522).",2020,Group physiotherapy was cheaper to deliver per patient (£252 versus £84).,"['Sub-Acromial Impingement', '136 patients were recruited, 68 randomised to each group', 'Patients referred by local general practitioners and physiotherapists were considered for inclusion']","['corticosteroid injection before physiotherapy', 'subacromial impingement (SAI', 'Individual or Group Physiotherapy', 'corticosteroid injections and physiotherapy']","['shoulder pain and disability index (SPADI', 'TOST', 'SPADI']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4704938', 'cui_str': 'Group Physiotherapy'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.232029,Group physiotherapy was cheaper to deliver per patient (£252 versus £84).,"[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ryans', 'Affiliation': 'General Practice Elective Care Service (MSK), Eastern GP Federations, Belfast, BT8 7AR, Ireland.'}, {'ForeName': 'Rhona', 'Initials': 'R', 'LastName': 'Galway', 'Affiliation': 'Rheumatology Department, South Eastern Health and Social Services Trust, Dundonald BT16 1RH, Ireland.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Harte', 'Affiliation': 'School of Health Sciences, Ulster University, Belfast BT37 0QB, Ireland.'}, {'ForeName': 'Rejina', 'Initials': 'R', 'LastName': 'Verghis', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast BT12 6BA, Ireland.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Agus', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast BT12 6BA, Ireland.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Heron', 'Affiliation': ""Department of General Practice, Queen's University Belfast, Belfast BT7 1NN, UK.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'McKane', 'Affiliation': 'Rheumatology Department, South Eastern Health and Social Services Trust, Dundonald BT16 1RH, Ireland.'}]",International journal of environmental research and public health,['10.3390/ijerph17155565']
2538,30596265,Social Media Vaccine Websites: A Comparative Analysis of Public and Moderated Websites.,"The internet is an important source of vaccine information for parents. We evaluated and compared the interactive content on an expert moderated vaccine social media (VSM) website developed for parents of children 24 months of age or younger and enrolled in a health care system to a random sample of interactions extracted from publicly available parenting and vaccine-focused blogs and discussion forums. The study observation period was September 2013 through July 2016. Three hundred sixty-seven eligible websites were located using search terms related to vaccines. Seventy-nine samples of interactions about vaccines on public blogs and discussion boards and 61 interactions from the expert moderated VSM website were coded for tone, vaccine stance, and accuracy of information. If information was inaccurate, it was coded as corrected, partially corrected or uncorrected. Using chi-square or Fisher's exact tests, we compared coded interactions from the VSM website with coded interactions from the sample of publicly available websites. We then identified representative quotes to illustrate the quantitative results. Tone, vaccine stance, and accuracy of information were significantly different (all p < .05). Publicly available vaccine websites tended to be more contentious and have a negative stance toward vaccines. These websites also had inaccurate and uncorrected information. In contrast, the expert moderated website had a more civil tone, minimal posting of inaccurate information, with very little participant-to-participant interaction. An expert moderated, interactive vaccine website appears to provide a platform for parents to gather accurate vaccine information, express their vaccine concerns and ask questions of vaccine experts.",2019,"Tone, vaccine stance, and accuracy of information were significantly different (all p < .05).","['parents', 'Three hundred sixty-seven eligible websites', 'parents of children 24 months of age or younger and enrolled in a health care system to a random sample of interactions extracted from publicly available parenting and vaccine-focused blogs and discussion forums']","['expert moderated vaccine social media (VSM) website', 'Social Media Vaccine Websites']","['Tone, vaccine stance, and accuracy of information']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C2718045', 'cui_str': 'Blogs as Topic'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.026545,"Tone, vaccine stance, and accuracy of information were significantly different (all p < .05).","[{'ForeName': 'Jo Ann', 'Initials': 'JA', 'LastName': 'Shoup', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Komal J', 'Initials': 'KJ', 'LastName': 'Narwaney', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Wagner', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Kraus', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Gleason', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Albright', 'Affiliation': '2 University of Denver, Denver, CO, USA.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Glanz', 'Affiliation': '1 Kaiser Permanente Colorado, Denver, CO, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198118818253']
2539,32800909,Impact of cognitive behavioral therapy on depression symptoms after transcatheter aortic valve replacement: A randomized controlled trial.,"BACKGROUND
Depression is a significant concern after cardiac surgery and has not been studied in patients undergoing transcatheter aortic valve replacement (TAVR). We sought to examine the prevalence of pre-procedure depression and anxiety symptoms and explore whether brief bedside cognitive behavioral therapy (CBT) could prevent post-TAVR psychological distress.
METHODS
We prospectively recruited consecutive TAVR patients and randomized them to receive brief CBT or treatment as usual (TAU) during their hospitalization. Multi-level regression techniques were used to evaluate changes by treatment arm in depression, anxiety, and quality of life from baseline to 1 month post-TAVR adjusted for sex, race, DM, CHF, MMSE, and STS score.
RESULTS
One hundred and forty six participants were randomized. The mean age was 82 years, and 43% were female. Self-reported depression and anxiety scores meeting cutoffs for clinical level distress were 24.6% and 23.2% respectively. Both TAU and CBT groups had comparable improvements in depressive symptoms at 1-month (31% reduction for TAU and 35% reduction for CBT, p = .83). Similarly, both TAU and CBT groups had comparable improvements in anxiety symptoms at 1-month (8% reduction for TAU and 11% reduction for CBT, p = .1). Quality of life scores also improved and were not significantly different between the two groups.
CONCLUSIONS
Pre-procedure depression and anxiety may be common among patients undergoing TAVR. However, TAVR patients show spontaneous improvement in depression and anxiety scores at 1-month follow up, regardless of brief CBT. Further research is needed to determine whether more tailored CBT interventions may improve psychological and medical outcomes.",2020,"Both TAU and CBT groups had comparable improvements in depressive symptoms at 1-month (31% reduction for TAU and 35% reduction for CBT, p = .83).","['The mean age was 82\u202fyears, and 43% were female', 'patients undergoing transcatheter aortic valve replacement (TAVR', 'patients undergoing TAVR', 'One hundred and forty six participants were randomized', 'depression symptoms after transcatheter aortic valve replacement']","['bedside cognitive behavioral therapy (CBT', 'TAU and CBT', 'CBT or treatment as usual (TAU', 'cognitive behavioral therapy', 'TAVR']","['Quality of life scores', 'anxiety symptoms', 'depression, anxiety, and quality of life', 'depression and anxiety scores', 'depressive symptoms', 'Self-reported depression and anxiety scores meeting cutoffs for clinical level distress']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",146.0,0.118211,"Both TAU and CBT groups had comparable improvements in depressive symptoms at 1-month (31% reduction for TAU and 35% reduction for CBT, p = .83).","[{'ForeName': 'Katharine S', 'Initials': 'KS', 'LastName': 'Edwards', 'Affiliation': 'Department of Medicine, Stanford University, United States of America. Electronic address: ksedwards@stanford.edu.'}, {'ForeName': 'Eric K H', 'Initials': 'EKH', 'LastName': 'Chow', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, United States of America.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Dao', 'Affiliation': 'Department of Medicine, Stanford University, United States of America.'}, {'ForeName': 'Derik', 'Initials': 'D', 'LastName': 'Hossepian', 'Affiliation': 'PGSP-Stanford Psy.D. Consortium, Palo Alto University, United States of America.'}, {'ForeName': 'Audrey G', 'Initials': 'AG', 'LastName': 'Johnson', 'Affiliation': 'PGSP-Stanford Psy.D. Consortium, Palo Alto University, United States of America.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, United States of America.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, Stanford University, United States of America.'}, {'ForeName': 'Anson', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiothoracic Surgery, Stanford University, United States of America.'}, {'ForeName': 'Alan C', 'Initials': 'AC', 'LastName': 'Yeung', 'Affiliation': 'Department of Medicine, Stanford University, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fischbein', 'Affiliation': 'Department of Cardiothoracic Surgery, Stanford University, United States of America.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Fearon', 'Affiliation': 'Department of Medicine, Stanford University, United States of America.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.08.007']
2540,32807013,Low-Frequency Repetitive Transcranial Magnetic Stimulation Over Contralesional Motor Cortex for Motor Recovery in Subacute Ischemic Stroke: A Randomized Sham-Controlled Trial.,"BACKGROUND
Low-frequency repetitive transcranial magnetic stimulation (rTMS) over the contralesional motor cortex (M1) has demonstrated beneficial effects on motor recovery, but evidence among patients with subacute stroke is lacking. We aimed to investigate whether 1-Hz rTMS over the contralesional M1 versus sham rTMS could improve arm function in patients with subacute ischemic stroke when combined with rehabilitative motor training.
METHODS
In total, 77 patients who were within 90 days after their first-ever ischemic stroke were enrolled and randomly allocated to either real (n = 40) or sham rTMS (n = 37). We delivered 1-Hz 30-minute active or sham rTMS before each daily 30-minute occupational therapy sessions over a 2-week period. The primary endpoint was changes in the Box and Block Test (BBT) score immediately after the end of treatment (EOT). Secondary analyses assessed changes in Fugl-Meyer assessment, Finger Tapping Test (FTT), Brunnstrom stage, and grip strength.
CLINICAL TRIAL REGISTRATION
ClinialTrials.gov (NCT02082015).
RESULTS
Changes in BBT immediately after the end of treatment did not differ significantly between the 2 groups ( P = .267). Subgroup analysis according to cortical involvement revealed that real rTMS resulted in improvements in BBT at 1 month after EOT (17.4 ± 9.8 real vs 10.9 ± 10.3 sham; P = .023) and Brunnstrom stage of the hand immediately after EOT (0.6 ± 0.5 real vs 0.2 ± 0.5 sham; P = .023), only in the group without cortical involvement.
CONCLUSION
The effects of real and sham rTMS did not differ significantly among patients within 3 months poststroke. The location of stroke lesions should be considered for future clinical trials.",2020,"Subgroup analysis according to cortical involvement revealed that real rTMS resulted in improvements in BBT at 1 month after EOT (17.4 ± 9.8 real vs 10.9 ± 10.3 sham; P = .023) and Brunnstrom stage of the hand immediately after EOT (0.6 ± 0.5 real vs 0.2 ± 0.5 sham; P = .023), only in the group without cortical involvement.
","['Subacute Ischemic Stroke', '77 patients who were within 90 days after their first-ever ischemic stroke', 'patients within 3 months poststroke', 'patients with subacute stroke', 'patients with subacute ischemic stroke']","['contralesional M1 versus sham rTMS', '1-Hz rTMS', 'sham rTMS', 'Low-frequency repetitive transcranial magnetic stimulation (rTMS', 'Low-Frequency Repetitive Transcranial Magnetic Stimulation Over Contralesional Motor Cortex', '1-Hz 30-minute active or sham rTMS']","['Fugl-Meyer assessment, Finger Tapping Test (FTT), Brunnstrom stage, and grip strength', 'BBT', 'Box and Block Test (BBT) score']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",77.0,0.483945,"Subgroup analysis according to cortical involvement revealed that real rTMS resulted in improvements in BBT at 1 month after EOT (17.4 ± 9.8 real vs 10.9 ± 10.3 sham; P = .023) and Brunnstrom stage of the hand immediately after EOT (0.6 ± 0.5 real vs 0.2 ± 0.5 sham; P = .023), only in the group without cortical involvement.
","[{'ForeName': 'Won-Seok', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, South Korea.'}, {'ForeName': 'Bum Sun', 'Initials': 'BS', 'LastName': 'Kwon', 'Affiliation': 'Department of Rehabilitation Medicine, Dongguk University College of Medicine, Dongguk University Ilsan Hospital, Ilsandong-gu, Goyang, South Korea.'}, {'ForeName': 'Han Gil', 'Initials': 'HG', 'LastName': 'Seo', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, South Korea.'}, {'ForeName': 'Nam-Jong', 'Initials': 'NJ', 'LastName': 'Paik', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, South Korea.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320948610']
2541,32808484,Is Dietary Nonadherence Unique to Obesity and Weight Loss? Results From a Randomized Clinical Trial.,"OBJECTIVE
Weight stigma is associated with poor dietary adherence, yet adherence is essential for weight loss and maintenance. This study aimed to determine differences in dietary adherence and perceived hunger between lean individuals and two groups of individuals with obesity.
METHODS
In a 6-week outpatient dietary intervention (23 males; aged 48 [SD 14] years), lean participants (n = 23; BMI 23 [SD 2] kg/m 2 ) received a weight-maintaining energy needs (WMEN) diet, and participants with obesity (BMI 36 [SD 7]) were randomized to either WMEN (n = 18) or a 35% calorie-reduced (CR) diet (n = 19). All food was provided, and multiple adherence and hunger ratings were assessed daily and weekly on an outpatient basis and in person at twice-weekly visits (e.g., 24-hour recall, diaries).
RESULTS
Weight decreased more in the group of CR individuals with obesity (β = -0.301 kg/wk, P = 0.02) compared with the group of lean individuals and the group of WMEN individuals with obesity. However, total percent adherence did not differ between groups (P = 0.60), and hunger scores did not change across groups over time (P = 0.08).
CONCLUSIONS
Results indicate that there are no differences in dietary adherence between lean individuals and individuals with obesity and adherence is not associated with adiposity or hunger. Thus, the belief that nonadherence (e.g., lack of willpower) is unique to obesity is untrue and may perpetuate weight bias and stigma.",2020,"However, total percent adherence did not differ between groups (p=0.60) and hunger scores did not change across groups over time (p=0.08).
","['between lean and two groups of individuals with obesity', '23males; age 48±14), lean participants (n=23; BMI 23±2 kg/m 2 ) received a', 'and participants with obesity (BMI 36±7']","['outpatient dietary intervention', 'weight maintaining diet (WMEN', 'WMEN (n=18) or 35% calorie reduced (CR) diet']","['hunger scores', 'total percent adherence', 'dietary adherence', 'Weight', 'dietary adherence and perceived hunger']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0597085,"However, total percent adherence did not differ between groups (p=0.60) and hunger scores did not change across groups over time (p=0.08).
","[{'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Stinson', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Piaggi', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA.'}, {'ForeName': 'Susanne B', 'Initials': 'SB', 'LastName': 'Votruba', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Venti', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Lovato-Morales', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Engel', 'Affiliation': 'Sanford Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Krakoff', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA.'}, {'ForeName': 'Marci E', 'Initials': 'ME', 'LastName': 'Gluck', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.23008']
2542,32815418,Exploring mechanisms of action in clinical trials of complex surgical interventions using mediation analysis.,"BACKGROUND
Surgical interventions allow for tailoring of treatment to individual patients and implementation may vary with surgeon and healthcare provider. In addition, in clinical trials assessing two competing surgical interventions, the treatments may be accompanied by co-interventions.
AIMS
This study explores the use of causal mediation analysis to (1) delineate the treatment effect that results directly from the surgical intervention under study and the indirect effect acting through a co-intervention and (2) to evaluate the benefit of the surgical intervention if either everybody in the trial population received the co-intervention or nobody received it.
METHODS
Within a counterfactual framework, relevant direct and indirect effects of a surgical intervention are estimated and adjusted for confounding via parametric regression models, for the situation where both mediator and outcome are binary, with baseline stratification factors included as fixed effects and surgeons as random intercepts. The causal difference in probability of a successful outcome (estimand of interest) is calculated using Monte Carlo simulation with bootstrapping for confidence intervals. Packages for estimation within standard statistical software are reviewed briefly. A step by step application of methods is illustrated using the Amaze randomised trial of ablation as an adjunct to cardiac surgery in patients with irregular heart rhythm, with a co-intervention (removal of the left atrial appendage) administered to a subset of participants at the surgeon's discretion. The primary outcome was return to normal heart rhythm at one year post surgery.
RESULTS
In Amaze, 17% (95% confidence interval: 6%, 28%) more patients in the active arm had a successful outcome, but there was a large difference between active and control arms in the proportion of patients who received the co-intervention (55% and 30%, respectively). Causal mediation analysis suggested that around 1% of the treatment effect was attributable to the co-intervention (16% natural direct effect). The controlled direct effect ranged from 18% (6%, 30%) if the co-intervention were mandated, to 14% (2%, 25%) if it were prohibited. Including age as a moderator of the mediation effects showed that the natural direct effect of ablation appeared to decrease with age.
CONCLUSIONS
Causal mediation analysis is a useful quantitative tool to explore mediating effects of co-interventions in surgical trials. In Amaze, investigators could be reassured that the effect of the active treatment, not explainable by differential use of the co-intervention, was significant across analyses.",2020,"In Amaze, 17% (95% confidence interval: 6%, 28%) more patients in the active arm had a successful outcome, but there was a large difference between active and control arms in the proportion of patients who received the co-intervention (55% and 30%, respectively).","[""patients with irregular heart rhythm, with a co-intervention (removal of the left atrial appendage) administered to a subset of participants at the surgeon's discretion""]",['co-intervention or nobody received it'],['return to normal heart rhythm at one year post surgery'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205271', 'cui_str': 'Irregular'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0225832', 'cui_str': 'Structure of auricular appendage'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",,0.133141,"In Amaze, 17% (95% confidence interval: 6%, 28%) more patients in the active arm had a successful outcome, but there was a large difference between active and control arms in the proportion of patients who received the co-intervention (55% and 30%, respectively).","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sharples', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Olympia', 'Initials': 'O', 'LastName': 'Papachristofi', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Saleema', 'Initials': 'S', 'LastName': 'Rex', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""King's College London, London, UK.""}]","Clinical trials (London, England)",['10.1177/1740774520947644']
2543,32815423,Clinical review of the efficacy and safety of oral semaglutide in patients with type 2 diabetes considered for injectable GLP-1 receptor agonist therapy or currently on insulin therapy.,"Injectable therapies such as glucagon-like peptide-1 receptor agonists (GLP-1RAs) and insulin are high-efficacy options for people with type 2 diabetes (T2D) who require treatment intensification. In addition to high glycemic efficacy, GLP-1RAs offer weight loss benefits, and some agents have been shown to reduce cardiovascular risk. This article summarizes data from two clinical studies with the first oral GLP-1RA, oral semaglutide, in situations where injectable therapy is often considered, and provides guidance on use in primary care. PIONEER 4 compared oral semaglutide 14 mg with an injectable GLP-1RA, liraglutide 1.8 mg, or placebo in patients uncontrolled on oral glucose-lowering therapies. PIONEER 8 compared oral semaglutide with placebo in patients with T2D already on insulin therapy. Treatment with oral semaglutide gave similar reductions in glycated hemoglobin (HbA 1 c ) compared with liraglutide at 26 weeks, and significantly greater reductions at 52 weeks. Changes in body weight with oral semaglutide were significantly greater compared with liraglutide after 26 and 52 weeks. Adding oral semaglutide 7 or 14 mg to insulin resulted in significant reductions in HbA 1 c and body weight at both 26 and 52 weeks compared with placebo, and facilitated a decrease in total daily insulin dosage. Oral semaglutide was associated with low proportions of patients experiencing severe or blood glucose-confirmed symptomatic hypoglycemia when added to oral glucose-lowering therapies, and did not increase the incidence of such events when added to insulin. The tolerability profile of oral semaglutide was consistent with that seen for injectable GLP-1RAs, with gastrointestinal side effects seen most frequently; most were transient and tended to occur during dose escalation. For patients requiring treatment intensification after oral therapy or as add-on to insulin, oral semaglutide provides effective glucose lowering and body weight loss, with low risk of hypoglycemia, thus broadening the range of therapeutic options for treatment of T2D in primary care.",2020,"Adding oral semaglutide 7 or 14 mg to insulin resulted in significant reductions in HbA 1c and body weight at both 26 and 52 weeks compared with placebo, and facilitated a decrease in total daily insulin dosage.","['people with type 2 diabetes (T2D) who require treatment intensification', 'patients with T2D already on insulin therapy', 'patients with type 2 diabetes considered for injectable GLP-1 receptor agonist therapy or currently on insulin therapy', 'patients uncontrolled on oral glucose-lowering therapies']","['liraglutide', 'oral semaglutide', 'oral semaglutide 14 mg with an injectable GLP-1RA, liraglutide 1.8 mg, or placebo', 'glucagon-like peptide-1 receptor agonists (GLP-1RAs) and insulin', 'placebo']","['HbA 1c and body weight', 'body weight with oral semaglutide', 'total daily insulin dosage', 'body weight loss', 'low proportions of patients experiencing severe or blood-glucose-confirmed symptomatic hypoglycemia', 'glycated hemoglobin (HbA 1c ', 'tolerability profile of oral semaglutide']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0294087,"Adding oral semaglutide 7 or 14 mg to insulin resulted in significant reductions in HbA 1c and body weight at both 26 and 52 weeks compared with placebo, and facilitated a decrease in total daily insulin dosage.","[{'ForeName': 'Eugene E', 'Initials': 'EE', 'LastName': 'Wright', 'Affiliation': 'Charlotte Area Health Education Center , Charlotte, NC, USA.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Brigham and Women's Hospital; Harvard Medical School , Boston, MA, USA.""}]",Postgraduate medicine,['10.1080/00325481.2020.1798127']
2544,32820851,P300-mediated modulations in self-other processing under psychedelic psilocybin are related to connectedness and changed meaning: A window into the self-other overlap.,"The concept of self and self-referential processing has a growing explanatory value in psychiatry and neuroscience, referring to the cognitive organization and perceptual differentiation of self-stimuli in health and disease. Conditions in which selfhood loses its natural coherence offer a unique opportunity for elucidating the mechanisms underlying self-disturbances. We assessed the psychoactive effects of psilocybin (230 μg/kg p.o.), a preferential 5-HT1A/2A agonist known to induce shifts in self-perception. Our placebo-controlled, double-blind, within-subject crossover experiment (n = 17) implemented a verbal self-monitoring task involving vocalizations and participant identification of real-time auditory source- (self/other) and pitch-modulating feedback. Subjective experience and task performance were analyzed, with time-point-by-time-point assumption-free multivariate randomization statistics applied to the spatiotemporal dynamics of event-related potentials. Psilocybin-modulated self-experience, interacted with source to affect task accuracy, and altered the late phase of self-stimuli encoding by abolishing the distinctiveness of self- and other-related electric field configurations during the P300 timeframe. This last effect was driven by current source density changes within the supragenual anterior cingulate and right insular cortex. The extent of the P300 effect was associated with the intensity of psilocybin-induced feelings of unity and changed meaning of percepts. Modulations of late encoding and their underlying neural generators in self-referential processing networks via 5-HT signaling may be key for understanding self-disorders. This mechanism may reflect a neural instantiation of altered self-other and relational meaning processing in a stimulus-locked time domain. The study elucidates the neuropharmacological foundation of subjectivity, with implications for therapy, underscoring the concept of connectedness.",2020,The extent of the P300 effect was associated with the intensity of psilocybin-induced feelings of unity and changed meaning of percepts.,[],"['psilocybin', 'verbal self-monitoring task involving vocalizations and participant identification of real-time auditory source- (self/other) and pitch-modulating feedback']",['Subjective experience and task performance'],[],"[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0042932', 'cui_str': 'Singing, Animal'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",,0.0230626,The extent of the P300 effect was associated with the intensity of psilocybin-induced feelings of unity and changed meaning of percepts.,"[{'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Smigielski', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kometer', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Scheidegger', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Stress', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Katrin H', 'Initials': 'KH', 'LastName': 'Preller', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Koenig', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Franz X', 'Initials': 'FX', 'LastName': 'Vollenweider', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry, University of Zurich, Zurich, Switzerland.'}]",Human brain mapping,['10.1002/hbm.25174']
2545,31828315,A Randomized Clinical Trial Examining the Effects of Instructions for Electronic Cigarette Use on Smoking-Related Behaviors and Biomarkers of Exposure.,"INTRODUCTION
Electronic cigarettes (e-cigarettes) have the potential to significantly reduce exposure to harmful constituents associated with cigarette smoking when smokers completely substitute cigarettes with e-cigarettes. This study examined patterns of e-cigarette and cigarette use, and extent of toxicant exposure, if smokers were instructed and incentivized to completely switch to e-cigarettes compared to instructions to use the product ad libitum.
AIMS AND METHODS
US adult daily smokers (n = 264; 49.2% female; Mage = 47.0), uninterested in quitting smoking immediately, were recruited from Minneapolis, MN, Columbus, OH, and Buffalo, NY. Participants were randomized to 8 weeks of instructions for (1) ad libitum use of e-cigarettes (AD-E), (2) complete substitution of cigarettes with e-cigarettes (CS-E), (3) complete substitution of cigarettes with nicotine gum or lozenge (CS-NRT), or (4) continue smoking of usual brand cigarettes (UB). Participants were incentivized for protocol compliance, including complete switching in the CS-E and CS-NRT groups. Outcome variables were cigarette smoking rate and tobacco-related biomarkers of exposure.
RESULTS
Smokers in the CS-E and CS-NRT groups showed lower rates of smoking and lower exposure to carbon monoxide, tobacco carcinogens, and other toxicants than smokers in the AD-E group. In general, no significant differences were observed between CS-E versus CS-NRT or between AD-E versus UB for most biomarkers. Significantly higher 7-day point prevalence smoke-free rates were observed for CS-E versus CS-NRT.
CONCLUSIONS
Smokers instructed and incentivized to completely switch to e-cigarettes resulted in lower smoking rates and greater reductions in exposures to harmful chemicals than smokers instructed to use the product ad libitum.
IMPLICATIONS
Smokers instructed to completely substitute e-cigarettes for cigarettes displayed significantly lower levels of smoking and biomarkers of exposure to carcinogens and toxicants, compared to smokers instructed to use e-cigarettes ad libitum and similar levels as smokers instructed to completely substitute with nicotine replacement therapies. Furthermore, a higher rate of complete switching was achieved with e-cigarettes versus nicotine replacement therapies. Approaches to maximize complete substitution with e-cigarettes are an important area for future research.",2020,"RESULTS
Smokers in the CS-E and CS-NRT groups showed lower rates of smoking and lower exposure to carbon monoxide, tobacco carcinogens, and other toxicants than smokers in the AD-E group.","['US adult daily smokers (n = 264; 49.2% female; Mage = 47.0), uninterested in quitting smoking immediately, were recruited from Minneapolis, MN, Columbus, OH, and Buffalo, NY']","['nicotine replacement therapies', 'instructions for (1) ad libitum use of e-cigarettes (AD-E), (2) complete substitution of cigarettes with e-cigarettes (CS-E), (3) complete substitution of cigarettes with nicotine gum or lozenge (CS-NRT), or (4) continue smoking of usual brand cigarettes (UB']","['higher rate of complete switching', 'rates of smoking and lower exposure to carbon monoxide, tobacco carcinogens', 'smoking rates', '7-day point prevalence smoke-free rates', 'Smoking-Related Behaviors and Biomarkers of Exposure', 'cigarette smoking rate and tobacco-related biomarkers of exposure']","[{'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0238889', 'cui_str': 'Exposure to carbon monoxide'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0007090', 'cui_str': 'Carcinogen'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}]",,0.0151011,"RESULTS
Smokers in the CS-E and CS-NRT groups showed lower rates of smoking and lower exposure to carbon monoxide, tobacco carcinogens, and other toxicants than smokers in the AD-E group.","[{'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Meier', 'Affiliation': 'Department of Psychology, University of Wisconsin - Stevens Point, Stevens Point, WI.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Lindgren', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Reisinger', 'Affiliation': 'James Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Kaila J', 'Initials': 'KJ', 'LastName': 'Norton', 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Strayer', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Joni A', 'Initials': 'JA', 'LastName': 'Jensen', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dick', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Carmella', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Mei-Kuen', 'Initials': 'MK', 'LastName': 'Tang', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Menglan', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Hecht', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': ""O'connor"", 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Shields', 'Affiliation': 'James Cancer Center, The Ohio State University, Columbus, OH.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz233']
2546,32839137,Pharmacist-led motivational interviewing for diabetes medication adherence in a worksite wellness program.,"OBJECTIVE
The primary objective was to evaluate the impact of a pharmacist-delivered motivational interviewing (MI) intervention for diabetes medication adherence; the secondary objectives were to assess the changes in clinical outcomes and health-related quality of life (HRQoL).
METHODS
A quasi-experimental intervention study was conducted with baseline, postintervention, and follow-up data collections. The study duration was 6 months. Pharmacists trained in MI delivered 3 face-to-face encounters using MI-based semistructured conversation tools to address barriers or challenges to medication adherence. A diabetes worksite wellness program (WWP) at a 350-bed regional hospital in the southeastern United States was the setting, and the study participants were WWP employees or dependents (with type 1 diabetes or type 2 diabetes). The primary outcome was a change in self-reported diabetes medication adherence; the secondary outcomes included the changes in clinical indicators (glycated hemoglobin [HbA1c], blood pressure, and depressive symptoms), and HRQoL. The measures included the Medometer, Summary of Diabetes Self-Care Activities-Medication Subscale (SDSCA-MS), Audit of Diabetes-Dependent QoL (ADDQoL-19), and the Short Form-12 (SF-12) health survey.
RESULTS
Fifty-three WWP participants enrolled, and 36 completed the full intervention protocol. Medication adherence (through the Medometer) demonstrated statistically significant improvement after the intervention (P = 0.010); the SDSCA-MS score improved, but was not statistically significant. The change in diastolic blood pressure was statistically significant (P = 0.034), but the changes in HbA1c, systolic blood pressure, presence of depressive symptoms, and ADDQoL-19 were not statistically significant. The SF-12 physical component summary (PCS) and mental component summary (MCS) scores were statistically significant: PCS, P = 0.003, and MCS, P = 0.025.
CONCLUSION
The findings from this pilot study support the effectiveness of a pharmacist-delivered, semistructured MI-based intervention for medication adherence in persons with diabetes in a hospital-based WWP. Pharmacists can support patients' behavior change using MI communication skills to explore salient barriers to medication adherence and to facilitate goal setting to overcome these in encounters aimed at shared clinical and behavioral decision-making.",2020,"Medication adherence (through the Medometer) demonstrated statistically significant improvement after the intervention (P = 0.010); the SDSCA-MS score improved, but was not statistically significant.","['Fifty-three WWP participants enrolled, and 36 completed the full intervention protocol', 'persons with diabetes in a hospital-based WWP', 'A diabetes worksite wellness program (WWP) at a 350-bed regional hospital in the southeastern United States was the setting, and the study participants were WWP employees or dependents (with type 1 diabetes or type 2 diabetes', 'diabetes medication adherence']","['pharmacist-delivered motivational interviewing (MI) intervention', 'Pharmacist-led motivational interviewing', 'pharmacist-delivered, semistructured MI-based intervention']","['Medication adherence', 'diastolic blood pressure', 'clinical outcomes and health-related quality of life (HRQoL', 'Medometer, Summary of Diabetes Self-Care Activities-Medication Subscale (SDSCA-MS), Audit of Diabetes-Dependent QoL (ADDQoL-19), and the Short Form-12 (SF-12) health survey', 'change in self-reported diabetes medication adherence', 'SF-12 physical component summary (PCS) and mental component summary (MCS) scores', 'changes in HbA1c, systolic blood pressure, presence of depressive symptoms, and ADDQoL-19', 'changes in clinical indicators (glycated hemoglobin [HbA1c], blood pressure, and depressive symptoms), and HRQoL', 'SDSCA-MS score']","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0043113', 'cui_str': 'Wellness Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",53.0,0.0436153,"Medication adherence (through the Medometer) demonstrated statistically significant improvement after the intervention (P = 0.010); the SDSCA-MS score improved, but was not statistically significant.","[{'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Ekong', 'Affiliation': ''}, {'ForeName': 'Chiahung', 'Initials': 'C', 'LastName': 'Chou', 'Affiliation': ''}, {'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Lakin', 'Affiliation': ''}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Hardin', 'Affiliation': ''}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'Caralise', 'Initials': 'C', 'LastName': 'Hunt', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kavookjian', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2020.07.025']
2547,32835607,Effect of dispersed form on the bioavailability of β-carotene from daily intake in humans.,"In a randomized double-blind crossover study, a canned beverage was prepared using an emulsion dispersion formulation (EM) of β-carotene and a crystal dispersion formulation (CR) of β-carotene; the beverages were ingested by human subjects daily for 2 weeks to compare the β-carotene bioavailability. EM-β-carotene enhanced the β-carotene concentrations in human plasma approximately 4-fold, but CR-β-carotene showed no statistically significant enhancement. Bioaccessibility is the ratio of the solubilized fraction to the whole amount ingested. Bioaccessibility of β-carotene from EM-β-carotene was higher than that from CR-β-carotene in an in vitro digestion test. Contrarily, β-carotene from CR-β-carotene, consists of all- trans -β-carotene, was higher than that from EM-β-carotene, consists of a mixture of cis and all- trans -β-carotene, on the uptake by intestinal Caco-2 cells, suggesting that bioaccessibility was a critical factor in β-carotene bioavailability in this study. EM-β-carotene thus has potential as a food coloring agent with value added because it enhances β-carotene bioavailability.",2020,"EM-β-carotene enhanced the β-carotene concentrations in human plasma approximately 4-fold, but CR-β-carotene showed no statistically significant enhancement.",['humans'],"['EM-β-carotene', 'emulsion dispersion formulation (EM) of β-carotene and a crystal dispersion formulation (CR) of β-carotene']",['β-carotene bioavailability'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0007269', 'cui_str': 'Carotene'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0007269', 'cui_str': 'Carotene'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.0342202,"EM-β-carotene enhanced the β-carotene concentrations in human plasma approximately 4-fold, but CR-β-carotene showed no statistically significant enhancement.","[{'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Kotake-Nara', 'Affiliation': 'Food Research Institute, National Agriculture and Food Research Organization , Tsukuba, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Hase', 'Affiliation': 'Food Research Institute, National Agriculture and Food Research Organization , Tsukuba, Japan.'}]","Bioscience, biotechnology, and biochemistry",['10.1080/09168451.2020.1803728']
2548,32746775,Efficacy and safety of erenumab in women with a history of menstrual migraine.,"BACKGROUND
We performed a post hoc, subgroup analysis of a phase 3, randomized, double-blind, placebo-controlled study of erenumab for prevention of episodic migraine (STRIVE) to determine the efficacy and safety of erenumab in women with self-reported menstrual migraine.
METHODS
Patients received placebo, erenumab 70 mg, or erenumab 140 mg subcutaneously once monthly during the 6-month double-blind treatment phase of STRIVE. Women who reported history of menstrual migraine and who were ≤ 50 years old were included in the analysis. Endpoints were change from baseline in monthly migraine days (MMD) and monthly acute migraine-specific medication days (MSMD; among patients who took acute migraine-specific medications at baseline), proportion of patients achieving ≥ 50% reduction from baseline in MMD, and incidence of adverse events.
RESULTS
Among 814 women enrolled in STRIVE, 232 (28.5%) reported a history of menstrual migraine and were ≤ 50 years old. Of the 232 patients, 214 (92%) had a baseline MMD > 5, suggesting a high proportion of women with attacks outside of the 5-day perimenstrual window (2 days before and 3 days after the start of menstruation). Information on ""migraine days"" includes (and does not discriminate between) perimenstrual and intermenstrual migraine attacks. Between-group differences from placebo over months 4-6 for erenumab 70 mg and 140 mg were - 1.8 (P = 0.001) and - 2.1 (P < 0.001) days for MMD and - 1.6 (P = 0.002) and - 2.4 (P < 0.001) days for acute MSMD, respectively. The odds of having a ≥ 50% reduction from baseline in MMD over months 4-6 were 2.2 (P = 0.024) and 2.8 (P = 0.002) times greater for erenumab 70 mg and 140 mg, respectively, than for placebo. Erenumab had an overall safety profile comparable to placebo.
CONCLUSION
Data from this subgroup analysis of women with menstrual migraine are consistent with data from the overall STRIVE episodic migraine population, supporting the efficacy and safety of erenumab in women who experience menstrual migraine.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02456740. Registered 28 May 2015.",2020,"Between-group differences from placebo over months 4-6 for erenumab 70 mg and 140 mg were - 1.8 (P = 0.001) and - 2.1 (P < 0.001) days for MMD and - 1.6 (P = 0.002) and - 2.4 (P < 0.001) days for acute MSMD, respectively.","['women with menstrual migraine', 'Women who reported history of menstrual migraine and who were\u2009≤\u200950\u2009years old were included in the analysis', '814 women enrolled in STRIVE, 232 (28.5%) reported a history of menstrual migraine and were\u2009≤\u200950\u2009years old', 'women with a history of menstrual migraine', 'women with self-reported menstrual migraine', 'women who experience menstrual migraine']","['erenumab', 'placebo, erenumab 70\u2009mg, or erenumab 140\u2009mg subcutaneously', 'placebo']","['overall safety profile', 'Efficacy and safety', 'monthly migraine days (MMD) and monthly acute migraine-specific medication days (MSMD']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0269226', 'cui_str': 'Menstrual migraine'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",814.0,0.544437,"Between-group differences from placebo over months 4-6 for erenumab 70 mg and 140 mg were - 1.8 (P = 0.001) and - 2.1 (P < 0.001) days for MMD and - 1.6 (P = 0.002) and - 2.4 (P < 0.001) days for acute MSMD, respectively.","[{'ForeName': 'Jelena M', 'Initials': 'JM', 'LastName': 'Pavlovic', 'Affiliation': 'Department of Neurology, Montefiore Headache Center, 1300 Morris Park Avenue, Van Etten 3C9, Bronx, NY, 10461, USA. jpavlovi@montefiore.org.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Paemeleire', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Göbel', 'Affiliation': 'Kiel Migraine and Headache Center, Kiel, Germany.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Bonner', 'Affiliation': 'Mercy Clinic Neurology, St Louis, MO, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Rapoport', 'Affiliation': 'The David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Kagan', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Picard', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",The journal of headache and pain,['10.1186/s10194-020-01167-6']
2549,32751340,The Effect of Gaseous Ozone Therapy in Conjunction with Periodontal Treatment on Glycated Hemoglobin Level in Subjects with Type 2 Diabetes Mellitus: An Unmasked Randomized Controlled Trial.,"BACKGROUND
It is established that inflammation is involved in the pathogenesis of Type 2 Diabetes Mellitus (T2DM) by promoting insulin resistance and impaired beta cell function in the pancreas. Among the hypothesized independent risk factors implicated in the pathogenetic basis of disease, periodontal infection has been proposed to promote an amplification of the magnitude of the advanced glycation end product (AGE)-mediated upregulation of cytokine synthesis and secretion. These findings suggest an interrelationship between periodontal disease and type 2 diabetes, describing poor metabolic control in subjects with periodontitis as compared to nondiabetic subjects and more severe periodontitis in subjects with T2DM as compared to a healthy population, with a significant positive correlation between periodontal inflammatory parameters and glycated hemoglobin level. Results from clinical trials show that periodontal treatment is able to improve glycemic control in subjects with diabetes. Many therapeutic strategies have been developed to improve periodontal conditions in conjunction with conventional treatment, among which ozone (O 3 ) is of specific concern. The principal aim of this trial was to compare the clinical effectiveness of an intensive periodontal intervention consisting of conventional periodontal treatment in conjunction with ozone gas therapy in reducing glycated hemoglobin level in type 2 diabetic patients and standard periodontal treatment.
METHODS
This study was a 12-month unmasked randomized trial and included 100 patients aged 40-74 years older, with type 2 diabetes mellitus diagnosed. All the patients received conventional periodontal treatment, or periodontal treatment in conjunction with ozone gas therapy in a randomly assigned order (1:1). The primary outcome was a clinical measure of glycated hemoglobin level at 3, 6, 9 and 12 months from randomization. Secondary outcomes were changes in periodontal inflammatory parameters.
RESULTS
At 12 months, the periodontal treatment in conjunction with ozone gas therapy did not show significant differences than standard therapy in decreasing glycated hemoglobin (HbA1C) level and the lack of significant differences in balance is evident.
CONCLUSIONS
Although the change was not significant, periodontal treatment in conjunction with the gaseous ozone therapy tended to reduce the levels of glycated hemoglobin. The study shows a benefit with ozone therapy as compared to traditional periodontal treatment.",2020,"At 12 months, the periodontal treatment in conjunction with ozone gas therapy did not show significant differences than standard therapy in decreasing glycated hemoglobin (HbA1C) level and the lack of significant differences in balance is evident.
","['Subjects with Type 2 Diabetes Mellitus', 'type 2 diabetic patients and standard periodontal treatment', 'subjects with diabetes', '100 patients aged 40-74 years older, with type 2 diabetes mellitus diagnosed']","['intensive periodontal intervention', 'ozone therapy', 'conventional periodontal treatment', 'ozone gas therapy', 'conventional periodontal treatment, or periodontal treatment in conjunction with ozone gas therapy', 'Periodontal Treatment', 'Gaseous Ozone Therapy']","['glycated hemoglobin level', 'glycated hemoglobin (HbA1C) level', 'changes in periodontal inflammatory parameters', 'severe periodontitis', 'Glycated Hemoglobin Level', 'clinical measure of glycated hemoglobin level', 'levels of glycated hemoglobin', 'glycemic control']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4727847', 'cui_str': 'Ozone therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",100.0,0.0391699,"At 12 months, the periodontal treatment in conjunction with ozone gas therapy did not show significant differences than standard therapy in decreasing glycated hemoglobin (HbA1C) level and the lack of significant differences in balance is evident.
","[{'ForeName': 'Biagio', 'Initials': 'B', 'LastName': 'Rapone', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, ""Aldo Moro"" University of Bari, 70121 Bari, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Ferrara', 'Affiliation': 'Complex Operative Unit of Odontostomatology, Hospital S.S. Annunziata, 66100 Chieti, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Corsalini', 'Affiliation': 'Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Converti', 'Affiliation': 'Department of Emergency and Organ Transplantation, Division of Plastic and Reconstructive Surgery, ""Aldo Moro"" University of Bari, 70121 Bari, Italy.'}, {'ForeName': 'Felice Roberto', 'Initials': 'FR', 'LastName': 'Grassi', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, ""Aldo Moro"" University of Bari, 70121 Bari, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Santacroce', 'Affiliation': 'Ionian Department (DJSGEM), ""Aldo Moro"" University of Bari, 70121 Bari, Italy.'}, {'ForeName': 'Skender', 'Initials': 'S', 'LastName': 'Topi', 'Affiliation': 'Department of Clinical Disciplines, School of Technical Medical Sciences, University A. Xhuvani, 3001 Elbasan, Albania.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gnoni', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, ""Aldo Moro"" University of Bari, 70121 Bari, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Scacco', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, ""Aldo Moro"" University of Bari, 70121 Bari, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Scarano', 'Affiliation': 'Department of Oral Science, Nano and Biotechnology and CeSi-Met University of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Delvecchio', 'Affiliation': ""Department of Metabolic and Genetic Diseases, Giovanni XXIII Children's Hospital, 70126 Bari, Italy.""}]",International journal of environmental research and public health,['10.3390/ijerph17155467']
2550,32757652,Early mobilization reduces delirium after coronary artery bypass graft surgery.,"BACKGROUND
Postoperative delirium is common in patients undergoing coronary artery bypass grafting, characterized by cognitive decline. This study aimed to evaluate the effect of early planned mobilization on delirium after coronary artery bypass grafting.
METHODS
This double-blind randomized clinical trial enrolled 92 consecutive patients who underwent coronary artery bypass grafting from September to December 2018. The patients were divided into two groups of 46: a mobilization protocol was applied in the intervention group in the first 2 days after surgery; the control group received routine nursing care only. Demographic data, medical records, and Neecham confusion scores were analyzed.
RESULTS
Patients in the control group used cigarettes (31.1% vs. 11.1%, p = 0.020) and opium poppy for recreation (35.6% vs. 8.9%, p = 0.002) more frequently, had longer intubation times (11.91 ± 3.87 vs. 10.23 ± 2.71 h, p = 0.020), and fewer blood components infused (15.6% vs. 33.3%, p = 0.05). More patients in the intervention group had normal function on the 2nd postoperative day compared to the control group (25 vs. 2, respectively, p = 0.001). The intervention group had significantly higher Neecham scores on postoperative day 2 (22.49 ± 2.03 vs. 26.82 ± 2.10, p = 0.001). Multivariable analysis showed significant associations between Neecham score and age ( p = 0.022), ejection fraction ( p = 0.015), myocardial infarction ( p = 0.016), systolic pressure ( p = 0.009), and diastolic pressure ( p = 0.008).
CONCLUSIONS
Early planned mobilization was effective in reducing postoperative delirium in patients undergoing coronary artery bypass grafting.",2020,"RESULTS
Patients in the control group used cigarettes (31.1% vs. 11.1%, p = 0.020) and opium poppy for recreation (35.6% vs. 8.9%, p = 0.002) more frequently, had longer intubation times (11.91 ± 3.87 vs. 10.23 ± 2.71 h, p = 0.020), and fewer blood components infused (15.6% vs. 33.3%, p = 0.05).","['92 consecutive patients who underwent coronary artery bypass grafting from September to December 2018', 'patients undergoing coronary artery bypass grafting', 'patients undergoing coronary artery bypass grafting, characterized by cognitive decline', 'after coronary artery bypass graft surgery']","['mobilization protocol', 'control group received routine nursing care only', 'early planned mobilization']","['longer intubation times', 'delirium', 'Neecham scores', 'blood components', 'systolic pressure', 'diastolic pressure', 'normal function', 'myocardial infarction', 'postoperative delirium', 'ejection fraction', 'Demographic data, medical records, and Neecham confusion scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085430', 'cui_str': 'Transfusion of blood component'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}]",92.0,0.153849,"RESULTS
Patients in the control group used cigarettes (31.1% vs. 11.1%, p = 0.020) and opium poppy for recreation (35.6% vs. 8.9%, p = 0.002) more frequently, had longer intubation times (11.91 ± 3.87 vs. 10.23 ± 2.71 h, p = 0.020), and fewer blood components infused (15.6% vs. 33.3%, p = 0.05).","[{'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Shirvani', 'Affiliation': 'Department of Nursing and Midwifery, Isfahan (Khorasgan) Branch, Islamic Azad University, Isfahan, Iran.'}, {'ForeName': 'Seyed Ali', 'Initials': 'SA', 'LastName': 'Naji', 'Affiliation': 'Department of Nursing and Midwifery, Isfahan (Khorasgan) Branch, Islamic Azad University, Isfahan, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Davari', 'Affiliation': 'Department of Nursing and Midwifery, Isfahan (Khorasgan) Branch, Islamic Azad University, Isfahan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Sedighi', 'Affiliation': 'Department of Neuroscience, Faculty of Advanced Technologies in Medicine, Iran University of Medical Sciences, Tehran, Iran.'}]",Asian cardiovascular & thoracic annals,['10.1177/0218492320947230']
2551,32758672,Beneficial Effects of Role Reversal in Comparison to role-playing on negative cognitions about Other's Judgments for Social Anxiety Disorder.,"BACKGROUND AND OBJECTIVES
Negative beliefs about other's judgments play an important role in the development and maintenance of social anxiety disorder. The present experiment examined the effects of role-playing followed by role reversal compared to role-playing twice on altering these negative cognitions.
METHODS
Thirty-six adult social anxiety patients were randomized into two conditions: a role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal. Before the start of the experiment, patients were asked to report their negative cognitions about the other's judgments. Next, they were asked to rate the believability of these negative cognitions, as well as the probability and cost estimates of negative judgments by the other person, at three time-points: before the first block of role-playing, after the first block of role-playing, and after the second block of the experiment.
RESULTS
Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
LIMITATIONS
The most important limitation of the present study is that there was no control group to assess the effects of role-playing alone. Moreover, the second block of the experiment was repetitive in role-playing, however, it was a new task in role reversal.
CONCLUSIONS
The results support the hypothesis that role reversal is an effective technique that can be used to correct negative cognitions about other's judgments in SAD.",2020,"RESULTS
Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","['Thirty-six adult social anxiety patients', ""negative cognitions about Other's Judgments for Social Anxiety Disorder""]","['role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal']",[],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C0035822', 'cui_str': 'Role play technique'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",[],36.0,0.0134432,"RESULTS
Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","[{'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Abeditehrani', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands. Electronic address: H.Abeditehrani@uva.nl.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Dijk', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}, {'ForeName': 'Mohsen Dehghani', 'Initials': 'MD', 'LastName': 'Neyshabouri', 'Affiliation': 'University of Social Welfare and Rehabilitation Sciences, Department of Clinical Psychology, Tehran, Iran.'}, {'ForeName': 'Arnoud', 'Initials': 'A', 'LastName': 'Arntz', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101599']
2552,32762340,"Immunotherapy to reduce frequency of urinary tract infections in people with neurogenic bladder dysfunction; a pilot randomised, placebo-controlled trial.","OBJECTIVE
To establish the feasibility of a randomized, placebo-controlled trial to investigate the effect of a specific immunotherapy bacterial lysate OM-89 (Uro-Vaxom ® ) in reducing the frequency of urinary tract infections in people with neurogenic bladder dysfunction.
DESIGN
A parallel-group, double-blind, randomized, placebo-controlled trial.
SETTING
Patients at home, recruited through out-patient contact, social media and patient support groups.
SUBJECTS
People with a spinal cord injury, multiple sclerosis, transverse myelitis or cauda equina syndrome who had suffered three or more clinically diagnosed urinary tract infections treated with antibiotics over the preceding 12 months.
INTERVENTIONS
All participants took one capsule of oral OM-89 immunotherapy (6 mg) or matching Placebo (randomisation ratio 1:1), once daily in the morning for 3 months.
MAIN MEASURES
The primary outcome was occurrence of a symptomatic urinary tract infection treated with an antibiotic, assessed at 3 and 6 months. Feasibility measures included recruitment, retention and practical difficulties.
RESULTS
Of 115 patients screened, 49 were recruited, one withdrew before randomization, and 23 were allocated to the control group receiving matching placebo. Six participants, all in the control group, discontinued the intervention; all participants provided full data at both follow-up times. Over 6 months, 18/25 active group patients had 55 infections, and 18/23 control group patients had 47 infections. Most research and clinical procedures were practical, and acceptable to participants.
CONCLUSION
It is feasible to undertake a larger trial. We recommend broader inclusion criteria to increase eligibility and generalizability.",2020,"Six participants, all in the control group, discontinued the intervention; all participants provided full data at both follow-up times.","['115 patients screened', 'people with neurogenic bladder dysfunction', 'People with a spinal cord injury, multiple sclerosis, transverse myelitis or cauda equina syndrome who had suffered three or more clinically diagnosed urinary tract infections treated with antibiotics over the preceding 12\u2009months', 'Patients at home, recruited through out-patient contact, social media and patient support groups']","['Immunotherapy', 'oral OM-89 immunotherapy (6\u2009mg) or matching Placebo', 'control group receiving matching placebo', 'specific immunotherapy bacterial lysate OM-89 (Uro-Vaxom ® ', 'placebo']","['recruitment, retention and practical difficulties', 'occurrence of a symptomatic urinary tract infection treated with an antibiotic', '47 infections']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005697', 'cui_str': 'Neurogenic bladder'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0026976', 'cui_str': 'Transverse myelopathy syndrome'}, {'cui': 'C0392548', 'cui_str': 'Cauda equina syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0069460', 'cui_str': 'OM 89'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1569170', 'cui_str': 'polyvalent mechanical bacterial lysate'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",49.0,0.519255,"Six participants, all in the control group, discontinued the intervention; all participants provided full data at both follow-up times.","[{'ForeName': 'Derick T', 'Initials': 'DT', 'LastName': 'Wade', 'Affiliation': 'Oxford Institute of Nursing, Midwifery and Allied Health Research (OxINMAHR), Faculty of Health & Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cooper', 'Affiliation': 'NSIC Research Programme Manager, National Spinal Injury Centre (NSIC), Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust, Aylesbury, Bucks, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Peckham', 'Affiliation': 'Medical Statistician, Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, (NDORMS), University of Oxford, Botnar Research Centre, Headington, Oxford, UK.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Belci', 'Affiliation': 'Consultant in Spinal Cord Injuries, National Spinal Injury Centre (NSIC), Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust, Aylesbury, Bucks, UK.'}]",Clinical rehabilitation,['10.1177/0269215520946065']
2553,32771017,Comparing a standard and tailored approach to scaling up an evidence-based intervention for antiretroviral therapy for people who inject drugs in Vietnam: study protocol for a cluster randomized hybrid type III trial.,"BACKGROUND
People who inject drugs (PWID) bear a disproportionate burden of HIV infection and experience poor outcomes. A randomized trial demonstrated the efficacy of an integrated System Navigation and Psychosocial Counseling (SNaP) intervention in improving HIV outcomes, including antiretroviral therapy (ART) and medications for opioid use disorder (MOUD) uptake, viral suppression, and mortality. There is limited evidence about how to effectively scale such intervention. This protocol presents a hybrid type III effectiveness-implementation trial comparing two approaches for scaling-up SNaP. We will evaluate the effectiveness of SNaP implementation approaches as well as cost and the characteristics of HIV testing sites achieving successful or unsuccessful implementation of SNaP in Vietnam.
METHODS
Design: In this cluster randomized controlled trial, two approaches to scaling-up SNaP for PWID in Vietnam will be compared. HIV testing sites (n = 42) were randomized 1:1 to the standard approach or the tailored approach. Intervention mapping was used to develop implementation strategies for both arms. The standard arm will receive a uniform package of these strategies, while implementation strategies for the tailored arm will be designed to address site-specific needs.
PARTICIPANTS
HIV-positive PWID participants (n = 6200) will be recruited for medical record assessment at baseline; of those, 1500 will be enrolled for detailed assessments at baseline, 12, and 24 months. Site directors and staff at each of the 42 HIV testing sites will complete surveys at baseline, 12, and 24 months.
OUTCOMES
Implementation outcomes (fidelity, penetration, acceptability) and effectiveness outcomes (ART, MOUD uptake, viral suppression) will be compared between the arms. To measure incremental costs, we will conduct an empirical costing study of each arm and the actual process of implementation from a societal perspective. Qualitative and quantitative site-level data will be used to explore key characteristics of HIV testing sites that successfully or unsuccessfully implement the intervention for each arm.
DISCUSSION
Scaling up evidence-based interventions poses substantial challenges. The proposed trial contributes to the field of implementation science by applying a systematic approach to designing and tailoring implementation strategies, conducting a rigorous comparison of two promising implementation approaches, and assessing their incremental costs. Our study will provide critical guidance to Ministries of Health worldwide regarding the most effective, cost-efficient approach to SNaP implementation.
TRIAL REGISTRATION
NCT03952520 on Clinialtrials.gov. Registered 16 May 2019.",2020,"OUTCOMES
Implementation outcomes (fidelity, penetration, acceptability) and effectiveness outcomes (ART, MOUD uptake, viral suppression) will be compared between the arms.","['People who inject drugs (PWID', 'HIV-positive PWID participants (n = 6200) will be recruited for medical record assessment at baseline; of those, 1500 will be enrolled for detailed assessments at baseline, 12, and 24 months', 'HIV testing sites (n = 42', 'people who inject drugs in Vietnam']","['standard and tailored approach to scaling up an evidence-based intervention for antiretroviral therapy', 'integrated System Navigation and Psychosocial Counseling (SNaP) intervention', 'scaling-up SNaP']","['Implementation outcomes (fidelity, penetration, acceptability) and effectiveness outcomes (ART, MOUD uptake, viral suppression', 'HIV outcomes, including antiretroviral therapy (ART) and medications for opioid use disorder (MOUD) uptake, viral suppression, and mortality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C4517837', 'cui_str': '6200'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0841579', 'cui_str': 'Psychosocial counseling'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",6200.0,0.202582,"OUTCOMES
Implementation outcomes (fidelity, penetration, acceptability) and effectiveness outcomes (ART, MOUD uptake, viral suppression) will be compared between the arms.","[{'ForeName': 'Minh X B', 'Initials': 'MXB', 'LastName': 'Nguyen', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, 135 Dauer Dr, Chapel Hill, NC, 27599, USA. binhminh@live.unc.edu.'}, {'ForeName': 'Anh V', 'Initials': 'AV', 'LastName': 'Chu', 'Affiliation': 'University of North Carolina Project Vietnam, Lot E2 Duong Dinh Nghe St., Cau Giay, Hanoi, Vietnam.'}, {'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Powell', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Ha V', 'Initials': 'HV', 'LastName': 'Tran', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, 135 Dauer Dr, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Long H', 'Initials': 'LH', 'LastName': 'Nguyen', 'Affiliation': 'Vietnam Authority of HIV/AIDS Control, Land 8 That Thuyet St., Ba Dinh, Hanoi, Vietnam.'}, {'ForeName': 'An T M', 'Initials': 'ATM', 'LastName': 'Dao', 'Affiliation': 'Department of Epidemiology, Institute of Preventive Medicine and Public Health, 1 Ton That Tung St., Dong Da, Hanoi, Vietnam.'}, {'ForeName': 'Manh D', 'Initials': 'MD', 'LastName': 'Pham', 'Affiliation': 'Vietnam Authority of HIV/AIDS Control, Land 8 That Thuyet St., Ba Dinh, Hanoi, Vietnam.'}, {'ForeName': 'Son H', 'Initials': 'SH', 'LastName': 'Vo', 'Affiliation': 'Vietnam Authority of HIV/AIDS Control, Land 8 That Thuyet St., Ba Dinh, Hanoi, Vietnam.'}, {'ForeName': 'Ngoc H', 'Initials': 'NH', 'LastName': 'Bui', 'Affiliation': 'Department of Epidemiology, Institute of Preventive Medicine and Public Health, 1 Ton That Tung St., Dong Da, Hanoi, Vietnam.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Carl A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lancaster', 'Affiliation': 'Department of Epidemiology, College of Public Health, Ohio State University, 250 Cunz Hall, 1841 Neil Ave, Columbus, OH, 43210, USA.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Pence', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, 135 Dauer Dr, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Teerada', 'Initials': 'T', 'LastName': 'Sripaipan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, 135 Dauer Dr, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Diseases, UNC School of Medicine, 321 S Columbia St, Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Miller', 'Affiliation': 'Department of Epidemiology, College of Public Health, Ohio State University, 250 Cunz Hall, 1841 Neil Ave, Columbus, OH, 43210, USA.'}, {'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, 135 Dauer Dr, Chapel Hill, NC, 27599, USA. vgo@live.unc.edu.'}]",Implementation science : IS,['10.1186/s13012-020-01020-z']
2554,32777737,Evaluation of efficacy and safety of rituximab in combination with mycophenolate mofetil in patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD): A double-blind placebo-controlled randomized trial.,"INTRODUCTION
Nonspecific interstitial pneumonia (NSIP) are rare but severe diseases, with high mortality and morbidity, with no effective pharmacological treatment allowing for long-term remission, and therefore no clear therapeutic recommendations. Classic immunosuppressants are used as first-line treatment, with only one third of patients being responders and no clear recommendations exist for the choice of the second-line therapy. The EvER-ILD study is the first one to prospectively evaluate the efficacy and safety of rituximab and mycophenolate mofetil (MMF) versus placebo and MMF in a broad range of NSIP patients that did not respond to a first-line therapy. A pharmacokinetic-pharmacodynamic analysis based on rituximab serum concentrations will allow identification of potential factors associated with therapeutic response and/or adverse effects.
METHODS
EvER-ILD study is a French multicenter, prospective, randomized, double blind, placebo-controlled, superiority trial. Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment will be randomized in 2 groups of treatment: one course of rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group). The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months. Several clinical, biological, and quality of life secondary outcomes will be measured at 3, 6 and 12 months. A sample size of 122 patients (61 patients per group) would allow to show a point difference between groups in the change of FVC at 6 months, based on a common standard deviation for FVC change of 8% with a power of 90%, alpha 5% two-sided, and anticipating an extreme 10% drop-out rate.
ETHICS AND DISSEMINATION
The protocol was approved by the French Research Ethics Committee (CPP Tours Ouest 1 2016-R28) on November 10, 2016, and by the French competent authority (ANSM, reference 160771A-22) on December 1st, 2016. This article refers to protocol V2, dated November 18, 2016. An independent data safety monitoring board will review safety and tolerability data for the duration of the trial. Results will be disseminated via peer reviewed publication and presentation at international conferences.
TRIAL REGISTRATION NUMBER
NCT02990286 (clinicaltrials.gov), EudraCT 2016-003026-16 (European Medicines agency).",2020,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","['2016-003026-16 (European Medicines agency', '122 patients (61 patients per group', 'patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD', 'Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment']","['EudraCT', 'mycophenolate mofetil', 'rituximab and mycophenolate mofetil (MMF) versus placebo and MMF', 'rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group', 'rituximab', 'placebo']","['change in Forced Vital Capacity (FVC, % of predicted']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1290344', 'cui_str': 'Nonspecific interstitial pneumonia'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0073081', 'cui_str': 'resiniferatoxin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",,0.378227,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bejan-Angoulvant', 'Affiliation': 'Service de Pharmacologie médicale, CHRU de Tours, Hôpital Bretonneau, Université de Tours, Tours, France.'}, {'ForeName': 'J-Marc', 'Initials': 'JM', 'LastName': 'Naccache', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caille', 'Affiliation': 'Inserm CIC1415, CHRU Tours, Université de Tours, Université de Nantes, SPHERE, U1246, Tours, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Borie', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nunes', 'Affiliation': 'Service de pneumologie, centre constitutif pour les maladies pulmonaires rares, hôpital Avicenne, CHU Paris Seine-Saint-Denis, Bobigny, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ferreira', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cadranel', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Crestani', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'Service de Pneumologie, Centre national coordonnateur de référence des maladies pulmonaires rares, Hôpital Louis Pradel, Hospices civils de Lyon, UMR 754, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Marchand-Adam', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France. Electronic address: s.marchandadam@univ-tours.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory medicine and research,['10.1016/j.resmer.2020.100770']
2555,32788142,Development and Usability of a Novel Interactive Tablet App (PediAppRREST) to Support the Management of Pediatric Cardiac Arrest: Pilot High-Fidelity Simulation-Based Study.,"BACKGROUND
Pediatric cardiac arrest (PCA), although rare, is associated with high mortality. Deviations from international management guidelines are frequent and associated with poorer outcomes. Different strategies/devices have been developed to improve the management of cardiac arrest, including cognitive aids. However, there is very limited experience on the usefulness of interactive cognitive aids in the format of an app in PCA. No app has so far been tested for its usability and effectiveness in guiding the management of PCA.
OBJECTIVE
To develop a new audiovisual interactive app for tablets, named PediAppRREST, to support the management of PCA and to test its usability in a high-fidelity simulation-based setting.
METHODS
A research team at the University of Padova (Italy) and human-machine interface designers, as well as app developers, from an Italian company (RE:Lab S.r.l.) developed the app between March and October 2019, by applying an iterative design approach (ie, design-prototyping-evaluation iterative loops). In October-November 2019, a single-center nonrandomized controlled simulation-based pilot study was conducted including 48 pediatric residents divided into teams of 3. The same nonshockable PCA scenario was managed by 11 teams with and 5 without the app. The app user's experience and interaction patterns were documented through video recording of scenarios, debriefing sessions, and questionnaires. App usability was evaluated with the User Experience Questionnaire (UEQ) (scores range from -3 to +3 for each scale) and open-ended questions, whereas participants' workload was measured using the NASA Raw-Task Load Index (NASA RTLX).
RESULTS
Users' difficulties in interacting with the app during the simulations were identified using a structured framework. The app usability, in terms of mean UEQ scores, was as follows: attractiveness 1.71 (SD 1.43), perspicuity 1.75 (SD 0.88), efficiency 1.93 (SD 0.93), dependability 1.57 (SD 1.10), stimulation 1.60 (SD 1.33), and novelty 2.21 (SD 0.74). Team leaders' perceived workload was comparable (P=.57) between the 2 groups; median NASA RTLX score was 67.5 (interquartile range [IQR] 65.0-81.7) for the control group and 66.7 (IQR 54.2-76.7) for the intervention group. A preliminary evaluation of the effectiveness of the app in reducing deviations from guidelines showed that median time to epinephrine administration was significantly longer in the group that used the app compared with the control group (254 seconds versus 165 seconds; P=.015).
CONCLUSIONS
The PediAppRREST app received a good usability evaluation and did not appear to increase team leaders' workload. Based on the feedback collected from the participants and the preliminary results of the evaluation of its effects on the management of the simulated scenario, the app has been further refined. The effectiveness of the new version of the app in reducing deviations from guidelines recommendations in the management of PCA and its impact on time to critical actions will be evaluated in an upcoming multicenter simulation-based randomized controlled trial.",2020,"Team leaders' perceived workload was comparable (P=.57) between the two groups, median NASA RTLX score was 67.5 (interquartile range [IQR]=65.0-81.7) for the control group and 66.7 (IQR=54.2-76.7) for the intervention group.",['48 pediatric residents divided in teams of three'],[],"['median NASA RTLX score', 'NASA Raw-Task Load Index (NASA RTLX', 'median time to epinephrine', 'User Experience Questionnaire (UEQ']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242776', 'cui_str': 'National Aeronautics and Space Administration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0671974,"Team leaders' perceived workload was comparable (P=.57) between the two groups, median NASA RTLX score was 67.5 (interquartile range [IQR]=65.0-81.7) for the control group and 66.7 (IQR=54.2-76.7) for the intervention group.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Corazza', 'Affiliation': ""Division of Pediatric Emergency Medicine, Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Snijders', 'Affiliation': ""Division of Pediatric Emergency Medicine, Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Arpone', 'Affiliation': ""Division of Pediatric Emergency Medicine, Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Stritoni', 'Affiliation': ""Pediatric Intensive Care Unit, Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Martinolli', 'Affiliation': ""Division of Pediatric Emergency Medicine, Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Daverio', 'Affiliation': ""Pediatric Intensive Care Unit, Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Maria Giulia', 'Initials': 'MG', 'LastName': 'Losi', 'Affiliation': 'RE:Lab S.r.l., Reggio Emilia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Soldi', 'Affiliation': 'RE:Lab S.r.l., Reggio Emilia, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Tesauri', 'Affiliation': 'RE:Lab S.r.l., Reggio Emilia, Italy.'}, {'ForeName': 'Liviana', 'Initials': 'L', 'LastName': 'Da Dalt', 'Affiliation': ""Division of Pediatric Emergency Medicine, Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bressan', 'Affiliation': ""Division of Pediatric Emergency Medicine, Department of Women's and Children's Health, University of Padova, Padova, Italy.""}]",JMIR mHealth and uHealth,['10.2196/19070']
2556,32789505,Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials.,"Importance
A vaccine against coronavirus disease 2019 (COVID-19) is urgently needed.
Objective
To evaluate the safety and immunogenicity of an investigational inactivated whole-virus COVID-19 vaccine in China.
Interventions
In the phase 1 trial, 96 participants were assigned to 1 of the 3 dose groups (2.5, 5, and 10 μg/dose) and an aluminum hydroxide (alum) adjuvant-only group (n = 24 in each group), and received 3 intramuscular injections at days 0, 28, and 56. In the phase 2 trial, 224 adults were randomized to 5 μg/dose in 2 schedule groups (injections on days 0 and 14 [n = 84] vs alum only [n = 28], and days 0 and 21 [n = 84] vs alum only [n = 28]).
Design, Setting, and Participants
Interim analysis of ongoing randomized, double-blind, placebo-controlled, phase 1 and 2 clinical trials to assess an inactivated COVID-19 vaccine. The trials were conducted in Henan Province, China, among 96 (phase 1) and 224 (phase 2) healthy adults aged between 18 and 59 years. Study enrollment began on April 12, 2020. The interim analysis was conducted on June 16, 2020, and updated on July 27, 2020.
Main Outcomes and Measures
The primary safety outcome was the combined adverse reactions 7 days after each injection, and the primary immunogenicity outcome was neutralizing antibody response 14 days after the whole-course vaccination, which was measured by a 50% plaque reduction neutralization test against live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Results
Among 320 patients who were randomized (mean age, 42.8 years; 200 women [62.5%]), all completed the trial up to 28 days after the whole-course vaccination. The 7-day adverse reactions occurred in 3 (12.5%), 5 (20.8%), 4 (16.7%), and 6 (25.0%) patients in the alum only, low-dose, medium-dose, and high-dose groups, respectively, in the phase 1 trial; and in 5 (6.0%) and 4 (14.3%) patients who received injections on days 0 and 14 for vaccine and alum only, and 16 (19.0%) and 5 (17.9%) patients who received injections on days 0 and 21 for vaccine and alum only, respectively, in the phase 2 trial. The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted. The geometric mean titers of neutralizing antibodies in the low-, medium-, and high-dose groups at day 14 after 3 injections were 316 (95% CI, 218-457), 206 (95% CI, 123-343), and 297 (95% CI, 208-424), respectively, in the phase 1 trial, and were 121 (95% CI, 95-154) and 247 (95% CI, 176-345) at day 14 after 2 injections in participants receiving vaccine on days 0 and 14 and on days 0 and 21, respectively, in the phase 2 trial. There were no detectable antibody responses in all alum-only groups.
Conclusions and Relevance
In this interim report of the phase 1 and phase 2 trials of an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity; the study is ongoing. Efficacy and longer-term adverse event assessment will require phase 3 trials.
Trial Registration
Chinese Clinical Trial Registry Identifier: ChiCTR2000031809.",2020,"The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted.","['China', '96 participants', '224 adults', 'Henan Province, China, among 96 (phase 1) and 224 (phase 2) healthy adults aged between 18 and 59 years', '320 patients who were randomized (mean age, 42.8 years; 200 women [62.5']","['aluminum hydroxide (alum) adjuvant-only group', 'investigational inactivated whole-virus COVID-19 vaccine', 'Inactivated Vaccine Against SARS-CoV-2', 'placebo']","['serious adverse reactions', 'antibody responses', 'geometric mean titers of neutralizing antibodies', 'Safety and Immunogenicity Outcomes', 'safety and immunogenicity', 'plaque reduction neutralization test against live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', '7-day adverse reactions', 'neutralizing antibody response']","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517836', 'cui_str': '62.5'}]","[{'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027944', 'cui_str': 'Neutralization Tests'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",224.0,0.329137,"The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted.","[{'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Duan', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Yuntao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Dongyang', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Huajun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xinguo', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Ministry of Education Key Laboratory of Environment and Health and State Key Laboratory of Environmental Health (Incubation), School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Yunkai', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Wangyang', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xuewei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Zejun', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Zhengli', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xuqin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Lianghao', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Shihe', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Pan', 'Affiliation': 'Department of Epidemiology and Biostatistics, Ministry of Education Key Laboratory of Environment and Health and State Key Laboratory of Environmental Health (Incubation), School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wanshen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}]",JAMA,['10.1001/jama.2020.15543']
2557,32793846,Interleukin-6 May Not Affect Bone Resorption Marker CTX or Bone Formation Marker P1NP in Humans.,"Context
Interleukin 6 (IL-6) contributes to bone remodeling in preclinical studies. Clinical trials investigating the role of IL-6 in bone remodeling are limited.
Objective
To investigate if IL-6 regulates bone remodeling in humans.
Design
Plasma concentrations of the bone resorption marker carboxy-terminal type I collagen crosslinks (CTX) and of the bone formation marker procollagen type 1 N-terminal propeptide (P1NP) were measured during a mixed-meal tolerance test (MMTT) in 3 placebo-controlled human studies.
Participants
Five healthy individuals participated in study 1; 52 obese individuals, in study 2; and 10 healthy individuals, in study 3.
Interventions
Study 1 was a single-blinded crossover study consisting of a 1-h infusion of saline (placebo) or the IL-6 receptor antibody tocilizumab followed by an exercise bout. Study 2 was a randomized, double-blinded 12-week exercise training intervention study. Participants received infusions of saline or tocilizumab. Study 3 was a randomized, double-blinded, crossover study consisting of 30 min infusion of saline or IL-6.
Main outcomes measures
Effect of IL-6 on CTX levels.
Results
CTX was significantly ( P < 0.01) decreased during MMTTs in all 3 studies. Treatment with tocilizumab did not affect exercise or meal induced changes in plasma CTX or P1NP concentrations acutely (study 1) or after a 12-week treatment period (study 2). Exogenous IL-6 had no effect on CTX or P1NP plasma concentrations (study 3).
Conclusions
IL-6 may not regulate bone remodeling in humans.",2020,Treatment with tocilizumab did not affect exercise or meal induced changes in plasma CTX or P1NP concentrations acutely (study 1) or after a 12-week treatment period (study 2).,"['Participants\n\n\nFive healthy individuals participated in study 1; 52 obese individuals, in study 2; and 10 healthy individuals, in study 3', 'humans']","['saline or tocilizumab', 'I collagen crosslinks (CTX) and of the bone formation marker procollagen type 1 N-terminal propeptide (P1NP', 'saline (placebo', 'tocilizumab', 'IL-6', 'IL-6 receptor antibody tocilizumab']","['CTX or P1NP plasma concentrations', 'CTX levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]","[{'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",5.0,0.47895,Treatment with tocilizumab did not affect exercise or meal induced changes in plasma CTX or P1NP concentrations acutely (study 1) or after a 12-week treatment period (study 2).,"[{'ForeName': 'Louise L', 'Initials': 'LL', 'LastName': 'Lehrskov', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Kjeldsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Lyngbæk', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Regitse Højgaard', 'Initials': 'RH', 'LastName': 'Chirstensen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Wedell-Neergaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Søderlund', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Krogh-Madsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvaa093']
2558,32791321,Guilt and expressive writing for reducing alcohol use in college students: Study protocol for a randomized control trial.,"The current proposed study aims to evaluate expressive writing as a novel intervention for reducing problematic drinking among college students. College students are at increased risk for alcohol misuse compared to other adults, and the development of efficacious intervention approaches is an urgent priority. The vast majority of individually focused brief interventions targeting college drinking have focused on personalized feedback approaches and recent innovations have largely been limited to refinements of this paradigm, which require large-scale assessment and intricate programming for implementation. The present research proposes expressive writing as a novel alternative, which has been used extensively in other domains but not as an alcohol intervention strategy. We propose a theoretically-based approach that incorporates expression of the self-conscious emotion of guilt and the written analogue of change talk as proposed mechanisms of intervention efficacy. We will also examine individual differences in guilt-proneness as a moderator of intervention efficacy. Heavy drinking college students (N = 600) will be randomly assigned to one of six expressive writing conditions based on a 2 (alcohol vs. distress) × 2 (guilt vs. no guilt) + 1 (control writing) + 1 (personalized feedback) design. Participation in the study involves completion of a screening assessment, a baseline assessment, three in-lab intervention sessions, post-intervention assessments, and follow-up assessments one-month, three-months, six months, and twelve-months later. If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.",2020,"If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.","['College students', 'Heavy drinking college students (N\u202f=\u202f600', 'college students']","['\u202f1 (control writing', 'Guilt and expressive writing', 'six expressive writing conditions based on a 2 (alcohol vs. distress']",[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",[],600.0,0.018722,"If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.","[{'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Jordanna Lembo', 'Initials': 'JL', 'LastName': 'Riggs', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Chelsie M', 'Initials': 'CM', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Rowan University, Glassboro, NJ, United States of America.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL, United States of America.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Angosta', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America. Electronic address: jangosta@central.uh.edu.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Cunningham-Erdogdu', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America; Department of Psychology, University of Texas at Austin, Austin, TX, United States of America.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Health Disparities Research, University of Texas, MD Anderson Cancer Center, Houston, TX, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106107']
2559,32792614,Alterations in acid-base balance and high-intensity exercise performance after short-term and long-term exposure to acute normobaric hypoxic conditions.,"This investigation assessed the course of renal compensation of hypoxia-induced respiratory alkalosis by elimination of bicarbonate ions and impairments in anaerobic exercise after different durations of hypoxic exposure. Study A: 16 participants underwent a resting 12-h exposure to normobaric hypoxia (3,000 m). Blood gas analysis was assessed hourly. While blood pH was significantly increased, PO 2 , PCO 2 , and SaO 2 were decreased within the first hour of hypoxia, and changes remained consistent. A substantial reduction in [HCO 3 - ] levels was observed after 12 h of hypoxic exposure (- 1.35 ± 0.29 mmol/L, p ≤ 0.05). Study B: 24 participants performed in a randomized, cross-over trial portable tethered sprint running (PTSR) tests under normoxia and after either 1 h (n = 12) or 12 h (n = 12) of normobaric hypoxia (3,000 m). No differences occurred for PTSR-related performance parameters, but the reduction in blood lactate levels was greater after 12 h compared with 1 h (- 1.9 ± 2.2 vs 0.0 ± 2.3 mmol/L, p ≤ 0.05). These results indicate uncompensated respiratory alkalosis after 12 h of hypoxia and similar impairment of high-intensity exercise after 1 and 12 h of hypoxic exposure, despite a greater reduction in blood lactate responses after 12 h compared with 1 h of hypoxic exposure.",2020,"No differences occurred for PTSR-related performance parameters, but the reduction in blood lactate levels was greater after 12 h compared with 1 h (- 1.9 ± 2.2 vs 0.0 ± 2.3 mmol/L, p ≤ 0.05).",[' 16 participants underwent a'],"['resting 12-h exposure to normobaric hypoxia', 'portable tethered sprint running (PTSR) tests under normoxia and after either 1\xa0h (n\u2009=\u200912) or 12\xa0h (n\u2009=\u200912) of normobaric hypoxia']","['PTSR-related performance parameters', 'blood pH', 'PO 2 , PCO 2 , and SaO 2', 'blood lactate levels', 'Blood gas analysis', 'blood lactate responses', 'respiratory alkalosis']",[],"[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0577538', 'cui_str': 'Tethered'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0700308', 'cui_str': 'Protium'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0002064', 'cui_str': 'Respiratory alkalosis'}]",,0.0252108,"No differences occurred for PTSR-related performance parameters, but the reduction in blood lactate levels was greater after 12 h compared with 1 h (- 1.9 ± 2.2 vs 0.0 ± 2.3 mmol/L, p ≤ 0.05).","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Limmer', 'Affiliation': 'Institute of Sports Medicine and Sports Nutrition, Ruhr-University Bochum, Bochum, Germany. mirjam.limmer@rub.de.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'de Marées', 'Affiliation': 'Institute of Sports Medicine and Sports Nutrition, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Platen', 'Affiliation': 'Institute of Sports Medicine and Sports Nutrition, Ruhr-University Bochum, Bochum, Germany.'}]",Scientific reports,['10.1038/s41598-020-70762-z']
2560,32798463,Immediate vs Delayed Stenting in ST-Elevation Myocardial Infarction: Rationale and Design of the International PRIMACY Bayesian Randomized Controlled Trial.,"BACKGROUND
Primary percutaneous coronary intervention is used to restore blood flow in the infarct-related coronary artery, followed by immediate stenting to prevent reocclusion. Stents implanted in thrombus-laden arteries cause distal embolization, which paradoxically impairs myocardial reperfusion and ventricular function. Whether a strategy of delayed stenting improves outcomes in patients with acute ST-elevation myocardial infarction (STEMI) is uncertain.
METHODS
The Primary Reperfusion Secondary Stenting (PRIMACY) is a Bayesian prospective, randomized, open-label, blinded end point trial in which delayed vs immediate stenting in patients with STEMI were compared for prevention of cardiovascular death, nonfatal myocardial infarction, heart failure, or unplanned target vessel revascularization at 9 months. All participants were immediately reperfused, but those assigned to the delayed arm underwent stenting after an interval of 24 to 48 hours. This interval was bridged with antithrombin therapy to reduce thrombus burden. In the principal Bayesian hierarchical random effects analysis, data from exchangeable trials will be combined into a study prior and updated with PRIMACY into a posterior probability of efficacy.
RESULTS
A total of 305 participants were randomized across 15 centres in France and Canada between April 2014 and September 2017. At baseline, the median age of participants was 59 years, 81% were male, and 3% had a history of percutaneous coronary intervention. Results from PRIMACY will be updated from the patient-level data of 1568 participants enrolled in the Deferred Stent Trial in STEMI (DEFER; United Kingdom), Minimalist Immediate Mechanical Intervention (MIMI; France), Danish Trial in Acute Myocardial Infarction-3 (DANAMI-3; Denmark), and Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST Segment-Elevation Myocardial Infarction (INNOVATION, South Korea) trials.
CONCLUSIONS
We expect to clarify whether delayed stenting can safely reduce the occurrence of adverse cardiovascular end points compared with immediate stenting in patients with STEMI.",2020,We expect to clarify whether delayed stenting can safely reduce the occurrence of adverse cardiovascular end points compared with immediate stenting in patients with STEMI.,"['patients with acute ST-elevation myocardial infarction (STEMI', 'median age of participants was 59 years, 81% were male, and 3% had a history of percutaneous coronary intervention', 'Patients With ST Segment-Elevation Myocardial Infarction (INNOVATION, South Korea) trials', 'patients with STEMI', '1568 participants enrolled in the Deferred Stent Trial in STEMI (DEFER; United Kingdom', 'ST-Elevation Myocardial Infarction', '305 participants were randomized across 15 centres in France and Canada between April 2014 and September 2017']","['Immediate Stent Implantation Versus Deferred Stent Implantation', 'antithrombin therapy', 'delayed stenting', 'Immediate vs Delayed Stenting']","['cardiovascular death, nonfatal myocardial infarction, heart failure, or unplanned target vessel revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1320647', 'cui_str': 'History of percutaneous coronary intervention'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",305.0,0.36388,We expect to clarify whether delayed stenting can safely reduce the occurrence of adverse cardiovascular end points compared with immediate stenting in patients with STEMI.,"[{'ForeName': 'E Marc', 'Initials': 'EM', 'LastName': 'Jolicoeur', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montréal, Québec, Canada. Electronic address: marc.jolicoeur@icm-mhi.org.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Dendukuri', 'Affiliation': 'Centre for Outcomes Research, McGill University Health Centre-Research Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Belisle', 'Affiliation': 'Montreal Health Innovation Coordination Center, Montreal, Quebec, Canada.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Range', 'Affiliation': 'Department of Cardiology, Les Hôpitaux de Chartres, Euret-Loir, France.'}, {'ForeName': 'Geraud', 'Initials': 'G', 'LastName': 'Souteyrand', 'Affiliation': 'CHU-Clermont Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Bouisset', 'Affiliation': 'Toulouse Rangueil University Hospital (CHU), Toulouse, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Zemour', 'Affiliation': 'Centre Hospitalier Pierre Nouveau Cannes, Cannes, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Delarche', 'Affiliation': 'Centre Hospitalier de Pau, Pau, France.'}, {'ForeName': 'Brahim', 'Initials': 'B', 'LastName': 'Harbaoui', 'Affiliation': 'Hôpital Croix-Rousse and Hôpital Lyon Sud, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Schampaert', 'Affiliation': 'Hopital Sacre-Coeur, Interventional Cardiology, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kouz', 'Affiliation': 'Centre Hospitalier Régional de Lanaudiere, Joliette, Quebec, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'Centre Hospitalier Universitaire Nimes, Université de Montpellier, Nimes, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Boueri', 'Affiliation': 'Centre Hospitalier de Bastia, Bastia, France.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Mansour', 'Affiliation': ""Centre Hospitalier Universitaire de l'Université de Montréal, Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Marcaggi', 'Affiliation': 'Department of Cardiology, Centre Hospitalier de Vichy, Vichy, France.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McGillion', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Tanguay', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Brophy', 'Affiliation': 'McGill University Health Centre, Division of Cardiology, Montreal, Quebec, Canada.'}, {'ForeName': 'Cheol Woong', 'Initials': 'CW', 'LastName': 'Yu', 'Affiliation': 'Korea University Anam Hospital, Cardiovascular Center (Interventional Cardiology), Seoul, Republic of Korea.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'BHF Glasgow Cardiovascular Research Center, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow; and West of Scotland Heart and Lung Center, Golden Jubilee National Hospital, Dunbartonshire, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carrick', 'Affiliation': 'University Hospital Hairmyres, East Kilbride, Glasgow, United Kingdom.'}, {'ForeName': 'Dan Eik', 'Initials': 'DE', 'LastName': 'Høfsten', 'Affiliation': 'Rigshospitalet-Copenhagen University Hospital, Department of Cardiology, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Rigshospitalet-Copenhagen University Hospital, Department of Cardiology, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kober', 'Affiliation': 'Rigshospitalet-Copenhagen University Hospital, Department of Cardiology, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbæk', 'Affiliation': 'Dept of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Belle', 'Affiliation': 'Hospital of Annecy, Centre Hospitalier Annecy Genevois, Annecy, France.'}]",The Canadian journal of cardiology,['10.1016/j.cjca.2020.01.019']
2561,32798558,Dexmedetomidine alleviates non-ventilation associated lung injury via modulating immunology phenotypes of macrophages.,"AIMS
We aimed to evaluate the effect of Dexmedetomidine (Dex) on immunology function of macrophages and inflammatory reactions in non-ventilated lung tissues from both humans and rats.
MAIN METHODS
Patients scheduled for lung lobectomy were randomly assigned to traditional anesthesia group or Dex anesthesia group, 15 subjects in each group. CD68, CD86 and CD206 were used to mark activate and polarized macrophages using immunofluorescence staining in human lung tissues. Sprague-Dawley rats were used to set lung injury model and randomly divided into Control group, one-lung ventilation group (CLI group) and CLI + Dex group. Lung tissues and bronchoalveolar lavage fluid (BALF) from non-ventilated lungs were collected. The acquired lung tissues were subjected to hematoxylin-eosin (H&E) staining and the inflammatory cells in BALF were calculated. Levels of cytokines and chemokines were detected by enzyme-linked immunosorbent assays (ELISA).
KEY FINDINGS
Results from humans showed that anesthesia with Dex decreased the number of both CD68 positive cells and CD86 positive cells and down-regulated level of pro-inflammatory cytokines tumor necrosis factor-α (TNF-α) and monocyte chemotactic protein 1 (MCP-1) in human lung. Results from rats demonstrated that treatment with Dex reversed the increased inflammatory cells in lung and the increased levels of TNF-α, interleukin-1β (IL-β), MCP-1 and chemokine (C-X-C motif) ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
SIGNIFICANCE
This study showed that Dex modulated the activation and immunological function of macrophages in non-ventilated lung and revealed a protective role in collapsed lung injury.",2020,"ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
","['Patients scheduled for lung lobectomy', 'non-ventilated lung tissues from both humans and rats']","['traditional anesthesia group or Dex anesthesia', 'Dexmedetomidine (Dex', 'Control group, one-lung ventilation group (CLI group) and CLI\u202f+\u202fDex group', 'Dexmedetomidine', 'Dex']","['inflammatory cells in lung and the increased levels of TNF-α, interleukin-1β (IL-β), MCP-1 and chemokine (C-X-C motif', 'Levels of cytokines and chemokines', 'immunology function of macrophages and inflammatory reactions', 'Lung tissues and bronchoalveolar lavage fluid (BALF', 'number of both CD68 positive cells and CD86 positive cells and down-regulated level of pro-inflammatory cytokines tumor necrosis factor-α (TNF-α) and monocyte chemotactic protein 1 (MCP-1', 'anti-inflammatory cytokine interleukin-10 (IL-10']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C1453673', 'cui_str': 'CLU protein, human'}]","[{'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0006279', 'cui_str': 'Bronchoalveolar lavage fluid sample'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0527903', 'cui_str': 'Lymphocyte antigen CD86'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",15.0,0.0272658,"ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
","[{'ForeName': 'Qiying', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China. Electronic address: shenqiying-yy@163.com.'}, {'ForeName': 'Guanghong', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China; Department of Anesthesiology, the Fourth Affiliated Hospital of Anhui Medical University, Hefei 230000, China.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yongqi', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Xuesheng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China. Electronic address: liuxuesheng@ahmu.edu.cn.'}]",Life sciences,['10.1016/j.lfs.2020.118249']
2562,32842483,A Multiple Targeted Research Protocol for a Quasi-Experimental Trial in Primary School Children Based on an Active Break Intervention: The Imola Active Breaks (I-MOVE) Study.,"BACKGROUND
Children and adolescents should perform, according to the World Health Organization guidelines, at least 60 min of moderate-to-vigorous physical activity per-day in order to avoid the risk of metabolic and cardiovascular diseases. The school represents a fundamental setting to conduct interventions to promote physical activity (PA) and contrast sedentary behaviors. Active breaks (ABs), bouts of 10 min of PA conducted inside the classroom, seem to be a good strategy to promote PA and improve classroom behavior. The aim of this study protocol is to describe the design and the assessment of the Imola Active Breaks I-MOVE study.
METHODS
The I-MOVE study is a school-based intervention trial, with a quasi-experimental design, performed in a primary school. It involves one experimental-group performing the intervention, focused on ABs, and one control-group. Nine main outcomes are evaluated: PA and sedentary behaviors; health related fitness; motor control development; dietary patterns; anthropometric evaluation; sociodemographic determinants; cognitive function; time-on-task behavior and quality of life.
CONCLUSIONS
Results from the I-MOVE study will help to clarify the effects of incorporating ABs in the Italian school curriculum as a new public health strategy and an innovative school model oriented to the well-being of children and teachers for the best quality of school life.",2020,"Nine main outcomes are evaluated: PA and sedentary behaviors; health related fitness; motor control development; dietary patterns; anthropometric evaluation; sociodemographic determinants; cognitive function; time-on-task behavior and quality of life.
",['Primary School Children Based on an Active Break Intervention'],[],['evaluated: PA and sedentary behaviors; health related fitness; motor control development; dietary patterns; anthropometric evaluation; sociodemographic determinants; cognitive function; time-on-task behavior and quality of life'],"[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0170705,"Nine main outcomes are evaluated: PA and sedentary behaviors; health related fitness; motor control development; dietary patterns; anthropometric evaluation; sociodemographic determinants; cognitive function; time-on-task behavior and quality of life.
","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Masini', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Lanari', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Marini', 'Affiliation': 'Department of Life Quality Studies, University of Bologna, Campus of Rimini, 47921 Rimini, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Tessari', 'Affiliation': 'Department of Psychology, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Toselli', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Stagni', 'Affiliation': 'Department of Electrical, Electronic, and Information Engineering ""Guglielmo Marconi"" University of Bologna, 40136 Bologna, Italy.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Bisi', 'Affiliation': 'Department of Electrical, Electronic, and Information Engineering ""Guglielmo Marconi"" University of Bologna, 40136 Bologna, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bragonzoni', 'Affiliation': 'Department of Life Quality Studies, University of Bologna, Campus of Rimini, 47921 Rimini, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Gori', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Sansavini', 'Affiliation': 'Department of Psychology, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ceciliani', 'Affiliation': 'Department of Life Quality Studies, University of Bologna, Campus of Rimini, 47921 Rimini, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dallolio', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, 40126 Bologna, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17176123']
2563,32844366,Feasibility of Imported Self-Management Program for Elderly People with Chronic Pain: A Single-Arm Confirmatory Trial.,"INTRODUCTION
Multidisciplinary pain management programs incorporating a cognitive-behavioral therapy (CBT) approach have been reported to be helpful for elderly people with chronic pain. However, it is unclear whether the same program for elderly people with chronic pain would translate to different cultures. This study investigated whether a multidisciplinary program based on that of Nicholas et al. (Pain 154(6):824-835, 2013) in Australia would be effective for elderly people with chronic pain in Japan.
METHODS
Twenty-seven community-dwelling elderly people with chronic pain were enrolled to confirm changes (effect size d = 0.5) in pain disability, which were previously reported by Nicholas et al. The multidisciplinary program consisted of eight sessions (2 sessions a week for 4 weeks). Pain disability was assessed using the Pain Disability Assessment Scale (PDAS) as the primary outcome at the baseline, the beginning and the end of the program, and the 1- and 3-month (final) follow-up. We also assessed the pain severity, catastrophizing, pain self-efficacy, and physical function with the Timed Up and Go test (TUG) and the two-step test as secondary outcomes.
RESULTS
PDAS, pain catastrophizing, and pain self-efficacy were significantly improved immediately after the program compared with baseline, and these effects were maintained at 3-month follow-up. The effect size (d) for the PDAS score was a medium size (0.54) from baseline to 3-month follow-up. Those who showed improvements in TUG immediately after the program tended to report improved psychometric measures at 3-month follow-up.
CONCLUSION
These results suggest that the Japanese multidisciplinary program has a similar effect on pain disability as that reported by Nicholas et al. This finding has important implications for the development of pain services in community-dwelling elderly Japanese.",2020,"RESULTS
PDAS, pain catastrophizing, and pain self-efficacy were significantly improved immediately after the program compared with baseline, and these effects were maintained at 3-month follow-up.","['Twenty-seven community-dwelling elderly people with chronic pain', 'elderly people with chronic pain in Japan', 'elderly people with chronic pain', 'community-dwelling elderly Japanese', 'Elderly People with Chronic Pain']","['cognitive-behavioral therapy (CBT) approach', 'Imported Self-Management Program']","['psychometric measures', 'Pain disability', 'pain severity, catastrophizing, pain self-efficacy, and physical function with the Timed Up and Go test (TUG', 'PDAS, pain catastrophizing, and pain self-efficacy', 'pain disability', 'Pain Disability Assessment Scale (PDAS']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}]",,0.0331891,"RESULTS
PDAS, pain catastrophizing, and pain self-efficacy were significantly improved immediately after the program compared with baseline, and these effects were maintained at 3-month follow-up.","[{'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Ikemoto', 'Affiliation': 'Department of Orthopaedics, Aichi Medical University, Aichi, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Shiro', 'Affiliation': 'Nagoya Gakuin University, Nagoya, Japan. shiro823@ngu.ac.jp.'}, {'ForeName': 'Kayo', 'Initials': 'K', 'LastName': 'Ikemoto', 'Affiliation': 'Research of Pain Science, Non-Profit Organization, Nagoya, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Research of Pain Science, Non-Profit Organization, Nagoya, Japan.'}, {'ForeName': 'Young-Chang', 'Initials': 'YC', 'LastName': 'Arai', 'Affiliation': 'Research of Pain Science, Non-Profit Organization, Nagoya, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Deie', 'Affiliation': 'Department of Orthopaedics, Aichi Medical University, Aichi, Japan.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Beeston', 'Affiliation': 'Pain Management Research Institute, Faculty of Medicine and Health, University of Sydney and Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Wood', 'Affiliation': 'Pain Management Research Institute, Faculty of Medicine and Health, University of Sydney and Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nicholas', 'Affiliation': 'Pain Management Research Institute, Faculty of Medicine and Health, University of Sydney and Royal North Shore Hospital, Sydney, NSW, Australia.'}]",Pain and therapy,['10.1007/s40122-020-00192-2']
2564,32843659,Haptic sound-localisation for use in cochlear implant and hearing-aid users.,"Users of hearing-assistive devices often struggle to locate and segregate sounds, which can make listening in schools, cafes, and busy workplaces extremely challenging. A recent study in unilaterally implanted CI users showed that sound-localisation was improved when the audio received by behind-the-ear devices was converted to haptic stimulation on each wrist. We built on this work, using a new signal-processing approach to improve localisation accuracy and increase generalisability to a wide range of stimuli. We aimed to: (1) improve haptic sound-localisation accuracy using a varied stimulus set and (2) assess whether accuracy improved with prolonged training. Thirty-two adults with normal touch perception were randomly assigned to an experimental or control group. The experimental group completed a 5-h training regime and the control group were not trained. Without training, haptic sound-localisation was substantially better than in previous work on haptic sound-localisation. It was also markedly better than sound-localisation by either unilaterally or bilaterally implanted CI users. After training, accuracy improved, becoming better than for sound-localisation by bilateral hearing-aid users. These findings suggest that a wrist-worn haptic device could be effective for improving spatial hearing for a range of hearing-impaired listeners.",2020,These findings suggest that a wrist-worn haptic device could be effective for improving spatial hearing for a range of hearing-impaired listeners.,"['Thirty-two adults with normal touch perception', 'cochlear implant and hearing-aid users']",['Haptic sound-localisation'],"['spatial hearing', 'haptic sound-localisation accuracy']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C2350522', 'cui_str': 'Touch perception'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0919808', 'cui_str': 'Hearing aid user'}]","[{'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0475264', 'cui_str': 'Localization - action'}]","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0475264', 'cui_str': 'Localization - action'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",32.0,0.0396961,These findings suggest that a wrist-worn haptic device could be effective for improving spatial hearing for a range of hearing-impaired listeners.,"[{'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Fletcher', 'Affiliation': 'University of Southampton Auditory Implant Service, University of Southampton, University Road, Southampton, SO17 1BJ, UK. M.D.Fletcher@soton.ac.uk.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Zgheib', 'Affiliation': 'University of Southampton Auditory Implant Service, University of Southampton, University Road, Southampton, SO17 1BJ, UK.'}]",Scientific reports,['10.1038/s41598-020-70379-2']
2565,32843718,Long-term effectiveness of a lifestyle intervention on the prevention of type 2 diabetes in a middle-income country.,"This study aims to assess the effects of a community-based lifestyle intervention program on the incidence of type 2 diabetes (T2D). For this purpose, three communities in Tehran were chosen; one community received a face-to-face educational session embedded in a long-term community-wide lifestyle intervention aimed at supporting lifestyle changes. We followed up 9,204 participants (control: 5,739, intervention: 3,465) triennially from 1999 to 2015 (Waves 1-5). After a median follow-up of 3.5 years (wave 2), the risk of T2D was 30% lower in the intervention community as compared with two control communities by (Hazard-ratio: 0.70 [95% CI 0.53; 0.91]); however, the difference was not statistically significant in the following waves. After a median follow-up of 11.9 years (wave 5), there was a non-significant 6% reduction in the incidence of T2D in the intervention group as compared to the control group (Hazard-ratio: 0.94 [0.81, 1.08]). Moreover, after 11.9 years of follow-up, the intervention significantly improved the diet quality measured by the Dietary Approaches to Stop Hypertension concordance (DASH) score. Mean difference in DASH score in the intervention group versus control group was 0.2 [95% CI 0.1; 0.3]. In conclusion, the intervention prevented T2D by 30% in the short-term (3.5 years) but not long-term; however, effects on improvement of the diet maintained in the long-term.Registration: This study is registered at IRCT, a WHO primary registry ( https://irct.ir ). The registration date 39 is 2008-10-29 and the IRCT registration number is IRCT138705301058N1.",2020,Mean difference in DASH score in the intervention group versus control group was 0.2 [95% CI 0.1; 0.3].,"['Registration', '9,204 participants (control: 5,739, intervention: 3,465) triennially from 1999 to 2015', 'type 2 diabetes in a middle-income country', 'three communities in Tehran were chosen; one community received a']","['community-based lifestyle intervention program', 'lifestyle intervention', 'face-to-face educational session embedded in a long-term community-wide lifestyle intervention']","['incidence of type 2 diabetes (T2D', 'incidence of T2D', 'diet quality', 'Stop Hypertension concordance (DASH) score', 'DASH score', 'risk of T2D']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332464', 'cui_str': 'Widening'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",9204.0,0.0311052,Mean difference in DASH score in the intervention group versus control group was 0.2 [95% CI 0.1; 0.3].,"[{'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Lotfaliany', 'Affiliation': 'Non-Communicable Disease Control, School of Population and Global Health, University of Melbourne, Parkville, VIC, 3010, Australia.'}, {'ForeName': 'Mohamad Ali', 'Initials': 'MA', 'LastName': 'Mansournia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereidoun', 'Initials': 'F', 'LastName': 'Azizi', 'Affiliation': 'Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Hadaegh', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, P O Box: 19395-4763, Tehran, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Zafari', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, P O Box: 19395-4763, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Ghanbarian', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, P O Box: 19395-4763, Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Mirmiran', 'Affiliation': 'Nutrition and Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'Non-Communicable Disease Control, School of Population and Global Health, University of Melbourne, Parkville, VIC, 3010, Australia.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Khalili', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, P O Box: 19395-4763, Tehran, Iran. dkhalili@endocrine.ac.ir.'}]",Scientific reports,['10.1038/s41598-020-71119-2']
2566,32851490,Oral water ingestion in the treatment of shock patients: a prospective randomized study.,,2020,,['shock patients'],['Oral water ingestion'],[],"[{'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]",[],,0.0239991,,"[{'ForeName': 'Pierre-Grégoire', 'Initials': 'PG', 'LastName': 'Guinot', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon Bourgogne University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France. guinotpierregregoire@gmail.com.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Nguyen', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon Bourgogne University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Valerian', 'Initials': 'V', 'LastName': 'Duclos', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon Bourgogne University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Soudry-Faure', 'Affiliation': 'Unité de Soutien Méthodologique, DRCI, Dijon Bourgogne University Hospital, 21000, Dijon, France.'}, {'ForeName': 'Belaid', 'Initials': 'B', 'LastName': 'Bouhemad', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon Bourgogne University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06215-y']
2567,32852611,"Impact of naturopathy, yoga, and dietary interventions as adjuvant chemotherapy in the management of stage II and III adenocarcinoma of the colon.","INTRODUCTION
Naturopathy, Yoga and Dietary interventions are known to improve the quality of life in cancer patients. We aim to evaluate the effect of naturopathy interventions along with adjuvant chemotherapy in patients who underwent surgery for Adenocarcinoma of the Colon.
METHODS
A total of 116 adult patients were randomised in to one of the two groups; the experimental group received naturopathy, Yoga and Dietary interventions and the control group received psycho-social counselling in addition to standard chemotherapy. Haematological, biochemical and psychological evaluations were performed at set intervals during a total period of eighteen months starting from the first cycle of adjuvant chemotherapy.
RESULTS
Results showed that the overall hemoglobin (p < 0.0001) and carcinoembryonic antigen (CEA) (p = 0.0038) levels were statistically significant in patients on the experimental arm. The rest of the laboratory parameters, viz. total leukocyte count, platelet counts, and serum creatinine levels, for overall data was not statistically significant in both the groups. Psychological attributes such as anxiety, depression, symptom severity, and Functional Living Index: Cancer (FLIC) were found to be statistically significant (p < 0.0001) in the experimental subjects as compared with those in the control. On the whole, men benefited more than women from the study interventions.
CONCLUSIONS
We conclude that Yoga and Naturopathy interventions in addition to chemotherapy show improvement in overall functional life index along with improvement in haemoglobin in patients with stages II and III Adenocarcinoma of Colon.",2020,"total leukocyte count, platelet counts, and serum creatinine levels, for overall data was not statistically significant in both the groups.","['patients who underwent surgery for Adenocarcinoma of the Colon', 'cancer patients', 'patients with stages II and III Adenocarcinoma of Colon', 'stage II and III adenocarcinoma of the colon', '116 adult patients']","['Yoga and Naturopathy interventions', 'naturopathy, Yoga and Dietary interventions and the control group received psycho-social counselling in addition to standard chemotherapy', 'adjuvant chemotherapy', 'naturopathy, yoga, and dietary interventions', 'naturopathy interventions']","['Haematological, biochemical and psychological evaluations', 'Cancer (FLIC', 'overall functional life index', 'total leukocyte count, platelet counts, and serum creatinine levels', 'overall hemoglobin', 'quality of life', 'Psychological attributes such as anxiety, depression, symptom severity, and Functional Living Index', 'carcinoembryonic antigen (CEA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0338106', 'cui_str': 'Adenocarcinoma of colon'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0027495', 'cui_str': 'Naturopathy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0474156', 'cui_str': 'Social counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0204452', 'cui_str': 'Psychological assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}]",116.0,0.0338593,"total leukocyte count, platelet counts, and serum creatinine levels, for overall data was not statistically significant in both the groups.","[{'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Raghunath', 'Affiliation': 'Department of Academics, Basavatarakam Indo-American Cancer Hospital and Research Centre, Hyderabad, Telangana, India. kalpanaraghunath@induscancer.com.'}, {'ForeName': 'Ch', 'Initials': 'C', 'LastName': 'Sumathi', 'Affiliation': 'Department of Naturopathy and Yoga - Addlife, Basavatarakam Indo-American Cancer Hospital and Research Centre, Hyderabad, Telangana, India.'}, {'ForeName': 'Senthil J', 'Initials': 'SJ', 'LastName': 'Rajappa', 'Affiliation': 'Department of Medical Oncology, Basavatarakam Indo-American Cancer Hospital and Research Centre, Hyderabad, Telangana, India.'}, {'ForeName': 'M V T Krishna', 'Initials': 'MVTK', 'LastName': 'Mohan', 'Affiliation': 'Department of Medical Oncology, Basavatarakam Indo-American Cancer Hospital and Research Centre, Hyderabad, Telangana, India.'}, {'ForeName': 'Uday', 'Initials': 'U', 'LastName': 'Kumar', 'Affiliation': 'Department of Naturopathy and Yoga - Addlife, Basavatarakam Indo-American Cancer Hospital and Research Centre, Hyderabad, Telangana, India.'}, {'ForeName': 'Ummar', 'Initials': 'U', 'LastName': 'Shaik', 'Affiliation': 'Indian Institute of Information Technology and Management Kerala, Affiliated to Cochin University, Cochin, India.'}, {'ForeName': 'Mahendran', 'Initials': 'M', 'LastName': 'Botlagunta', 'Affiliation': 'Department of Indo American Cancer Research Foundation, Basavatarakam Indo-American Cancer Hospital and Research Centre, Hyderabad, Telangana, India. dr_bmnchowdary@induscancer.com.'}]",International journal of colorectal disease,['10.1007/s00384-020-03711-x']
2568,32846388,A Randomised Controlled Trial Examining the Effects of Self-Compassion Meditations on Women's Body Image.,"Although research has suggested that body image improves following self-compassion meditation training, studies have been limited due to the use of a wait-list control group. This study therefore compared the effects of self-compassion meditations to an active control group. Seventy young adult women (17-35 years) were randomly assigned to receive either self-compassion or nature-focused guided imagery meditations. Over one week, participants engaged in two meditations and completed pre- and post-test measures of trait self-compassion, body appreciation, body shame, and appearance-contingent self-worth. A mixed design analysis of variance revealed a main effect of time; women in both meditation groups demonstrated significant increases in self-compassion and body appreciation, and significant reductions in body shame. No effect was found for appearance-contingent self-worth. There were no interactions or main effects for group. Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations. Common elements between self-compassion and guided imagery may be a mechanism for improving body image. However, further research is warranted to isolate the effects of these meditations from other specific and non-specific treatment effects. (This study was pre-registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001814268).",2020,"Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations.","['Seventy young adult women (17-35 years', ""Women's Body Image""]","['Self-Compassion Meditations', 'self-compassion or nature-focused guided imagery meditations']","['self-compassion and body appreciation', 'body shame', 'trait self-compassion, body appreciation, body shame, and appearance-contingent self-worth']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",70.0,0.0359798,"Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations.","[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'de Wet', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: a_d088@student.usc.edu.au.'}, {'ForeName': 'Ben R', 'Initials': 'BR', 'LastName': 'Lane', 'Affiliation': 'Centre for Human Factors and Sociotechnical Systems, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: blane@usc.edu.au.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: kmulgrew@usc.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.07.009']
2569,32768403,"Effects of Dexamethasone and Photobiomodulation on Pain, Swelling, and Quality of Life After Buccal Fat Pad Removal: A Clinical Trial.","PURPOSE
In this study we aimed to compare the effects of photobiomodulation (PBM) and dexamethasone (DXM) on pain, swelling, and the quality-of-life (QOL) of patients submitted to buccal fat pad removal.
PATIENTS AND METHODS
A total of 20 patients with pseudoherniation of buccal fat pad were included in the present study. The patients were divided randomly into 2 groups: the PBM group (660 nm, 100 mW, 6 seconds, 2 J/cm 2 ) and the DXM group (4 mg every 8 hours for 3 days after the procedure). Pain levels were evaluated using a visual analog scale at days 2 and 4 after surgery, whereas the edema was evaluated by measuring the distance between 6 reference points: tragus, pogonion of the soft tissue, lateral eye commissure, the gonial angle, nose wing, and mouth commissure at days 2, 4, 7, 15, 30, 60, and 90. The QOL was evaluated using the Oral Health Impact Profile 14 questionnaire at days 2 and 4 after surgery.
RESULTS
There were no differences between the PBM and DXM groups in pain or edema. In terms of the QOL, the PBM group was significantly more comfortable when chewing than the DXM group (P < .05) CONCLUSION: The use of PBM at a power of 100 mW and 2 J/cm 2 per point had similar effects to oral DXM for the control of pain and edema, as well as in the QOL, except for masticatory function, which was significantly better in the PBM group.",2020,There were no differences between the LLLT and DXM groups in pain or edema.,"['patients submitted to buccal fat pad removal', '20 patients with pseudoherniation of buccal fat pad were included in the present study']","['Dexamethasone and Low-Level Laser Therapy', 'LLLT', 'DXM group', 'DXM', 'LLLT and DXM', 'low-level laser therapy (LLLT) and dexamethasone (DXM', 'oral DXM', 'Buccal Fat Pad Removal']","['Pain, Swelling, and Quality of Life', 'pain, swelling, and the quality of life (QOL', 'Pain levels', 'pain and edema', 'pain or edema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226900', 'cui_str': 'Buccal fat pad'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0360528', 'cui_str': 'Dexamethasone-containing product in oral dose form'}, {'cui': 'C0226900', 'cui_str': 'Buccal fat pad'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",20.0,0.0567639,There were no differences between the LLLT and DXM groups in pain or edema.,"[{'ForeName': 'Diego Assunção', 'Initials': 'DA', 'LastName': 'Calixto Da Silva', 'Affiliation': 'Resident, Dental School, University Center of Pará, Belém, Pará, Brazil.'}, {'ForeName': 'Fabio De Lucas Da', 'Initials': 'FLD', 'LastName': 'Silva Almeida', 'Affiliation': 'Resident, Dental School, University Center of Pará, Belém, Pará, Brazil.'}, {'ForeName': 'Tamara Melo Nunes', 'Initials': 'TMN', 'LastName': 'Ota', 'Affiliation': 'Resident, Dental School, University Center of Pará, Belém, Pará, Brazil.'}, {'ForeName': 'Douglas Magno', 'Initials': 'DM', 'LastName': 'Guimaraes', 'Affiliation': 'Professor, Dental School, University Center of Pará, Belém, Pará, Brazil; Staff, EBSERH, Belém, Pará, Brazil; and Posgradute Student, Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University - UNINOVE, São Paulo, São Paulo, Brazil. Electronic address: Douglas_guima@hotmail.com.'}, {'ForeName': 'Kristianne Porta Santos', 'Initials': 'KPS', 'LastName': 'Fernandes', 'Affiliation': 'Department Head, Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University - UNINOVE, São Paulo, São Paulo, Brazil.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.07.006']
2570,32771424,Evaluating the impact of the antrum size following laparoscopic sleeve gastrectomy: a randomized multicenter study.,"BACKGROUND
The effect of laparoscopic sleeve gastrectomy (LSG) on gastroesophageal reflux disease (GERD) remains discordant and highly related to the surgical technique. GERD and weight regain are probably understudied by prospective clinical studies depending on different technical factors.
OBJECTIVES
The purpose of this article is to evaluate the effect of extent to which the antrum is resected on GERD following LSG but also on early complications and short-term weight loss results.
SETTING
University Hospital, France.
METHODS
Patients were randomly assigned in group A (172 patients), LSG with antral resection, or group B (174 patients), LSG with antral preservation. The baseline characteristics collected were demographic characteristics and anthropometric data (age, sex, body mass index), presence of GERD clinical characteristics, ± pH-metry, postoperative complications, or gastrin level.
RESULTS
A total of 279 patients underwent LSG and they were included in the final analysis. The GERD analyzed at 3 months postoperatively by pH-metry was observed for 57.8% in group A and for 52.4% of patients in group B (P = .4819). There was no statistically significant difference (P = .3755) between the 2 groups at 1 year after surgery (group A, 49.5% versus group B, 43.6%). The gastrin serum level was analyzed 1 year after surgery for a total of 107 patients. For group A, the mean gastrin level was 97.4 ± 85.9 pg/mL, which was inferior compared with group B (150.6 ± 152.4 pg/mL) with no statistical difference (P = .067). The recorded excess weight loss for group A was 79.67% (± 28.88) with no statistically significant difference with group B 74.46% (± 36.61) (P = .3678). The mortality rate was nil. We recorded 5 cases of staple line leakage (3 in group A and 2 in group B); 11 patients presented bleeding (3 in group A and 8 group B), and 4 patients presented with gastric stenosis (2 in group A and 2 in group B).
CONCLUSIONS
The antrum preservation has no significant difference in terms of reflux, weight loss, or complications at 3 or 12 months following LSG. The only significant difference was achieved for nausea and vomiting symptoms, which were more significant for the antrum resection group. Further clinical trials with newer procedures will indicate the factors that can diminish the reflux following LSG. Furthermore, the conservation of a large part of the antrum may be helpful to convert the sleeve to another bariatric procedure (transit bipartition).",2020,"The antrum preservation has no significant difference in terms of reflux, weight loss, or complications at 3 or 12 months following LSG.","['Patients were randomly assigned in group A (172 patients', '279 patients underwent LSG and they were included in the final analysis', 'University Hospital, France']","['LSG with antral resection', 'laparoscopic sleeve gastrectomy', 'LSG with antral preservation', 'laparoscopic sleeve gastrectomy (LSG']","['demographic characteristics and anthropometric data (age, sex, body mass index), presence of GERD clinical characteristics, ± pH-metry, postoperative complications, or gastrin level', 'excess weight loss', 'GERD and weight regain', 'gastroesophageal reflux disease (GERD', 'mean gastrin level', 'nausea and vomiting symptoms', 'mortality rate', 'reflux, weight loss, or complications', 'bleeding', 'gastrin serum level', 'staple line leakage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0202036', 'cui_str': 'Gastrin measurement'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0017151', 'cui_str': 'Gastrins'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",279.0,0.0340159,"The antrum preservation has no significant difference in terms of reflux, weight loss, or complications at 3 or 12 months following LSG.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nocca', 'Affiliation': 'Unité bariatrique CHU de Montpellier, Montpellier, France; Université Montpellier 1, Montpellier, France. Electronic address: d-nocca@chu-montpellier.fr.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Picot', 'Affiliation': ""Université Montpellier 1, Montpellier, France; Département Information Médicale, Unité de Recherche Clinique et Epidémiologie, INSERM, Centre d'Investigation Clinique 1411, Montpellier, France.""}, {'ForeName': 'Ion', 'Initials': 'I', 'LastName': 'Donici', 'Affiliation': 'CHU Nimes, Nimes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Emungania', 'Affiliation': 'CHU Hôpital Nord, Marseille, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Jaussent', 'Affiliation': ""Département Information Médicale, Unité de Recherche Clinique et Epidémiologie, INSERM, Centre d'Investigation Clinique 1411, Montpellier, France.""}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Akouete', 'Affiliation': ""Département Information Médicale, Unité de Recherche Clinique et Epidémiologie, INSERM, Centre d'Investigation Clinique 1411, Montpellier, France.""}, {'ForeName': 'Alexandrine', 'Initials': 'A', 'LastName': 'Robert', 'Affiliation': 'Unité bariatrique CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Nedelcu', 'Affiliation': 'ELSAN, Clinique Saint Michel, Toulon, France; ELSAN, Clinique Bouchard, Marseille, France.'}, {'ForeName': 'Anamaria', 'Initials': 'A', 'LastName': 'Nedelcu', 'Affiliation': 'ELSAN, Clinique Saint Michel, Toulon, France.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.06.041']
2571,32780166,"Combination therapy of vitamin C and thiamine for septic shock: a multi-centre, double-blinded randomized, controlled study.","PURPOSE
To evaluate the effects of early combination therapy with intravenous vitamin C and thiamine on recovery from organ failure in patients with septic shock.
METHODS
The ascorbic acid and thiamine effect in septic shock (ATESS) trial was a multi-centre, double-blind, randomized, controlled trial conducted in four academic emergency departments, enrolling adult patients with septic shock from December 2018 through January 2020. Patients were randomly assigned in a 1:1 ratio to either the treatment group [intravenous vitamin C (50 mg/kg, maximum single dose 3 g) and thiamine (200 mg) administration every 12 h for a total of 48 h] or the placebo group (identical volume of 0.9% saline with the same protocol). The primary outcome was Δ Sequential Organ Failure Assessment (SOFA) score (SOFA score at enrolment-SOFA score after 72 h). Eighteen secondary outcomes were predefined, including shock reversal and 28-day mortality.
RESULTS
A total of 111 patients were enrolled, of which 53 were assigned to the treatment group and 58 were assigned to the placebo group. There was no significant difference in ΔSOFA scores between the treatment group and the placebo group [3, interquartile range (IQR) - 1 to 5 vs. 3, IQR 0-4, respectively, p = 0.96]. Predefined secondary outcomes were also not significantly different between the groups.
CONCLUSION
In this study, vitamin C and thiamine administration in the early phase of septic shock did not improve organ function compared with placebo, despite improvements in vitamin C and thiamine levels.",2020,"There was no significant difference in ΔSOFA scores between the treatment group and the placebo group [3, interquartile range (IQR) - 1 to 5 vs. 3, IQR 0-4, respectively, p = 0.96].","['septic shock', 'patients with septic shock', 'four academic emergency departments, enrolling adult patients with septic shock from December 2018 through January 2020', 'A total of 111 patients were enrolled, of which 53 were assigned to the treatment group and 58 were assigned to the']","['ascorbic acid and thiamine', 'thiamine', 'vitamin C and thiamine', 'intravenous vitamin C', 'placebo']","['ΔSOFA scores', 'Sequential Organ Failure Assessment (SOFA) score (SOFA score at enrolment-SOFA score', 'organ function', 'vitamin C and thiamine levels', 'shock reversal and 28-day mortality']","[{'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",111.0,0.826426,"There was no significant difference in ΔSOFA scores between the treatment group and the placebo group [3, interquartile range (IQR) - 1 to 5 vs. 3, IQR 0-4, respectively, p = 0.96].","[{'ForeName': 'Sung Yeon', 'Initials': 'SY', 'LastName': 'Hwang', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea.'}, {'ForeName': 'Seung Mok', 'Initials': 'SM', 'LastName': 'Ryoo', 'Affiliation': 'Department of Emergency Medicine, Asan Medical Centre, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 138-736, Korea.'}, {'ForeName': 'Jong Eun', 'Initials': 'JE', 'LastName': 'Park', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea.'}, {'ForeName': 'You Hwan', 'Initials': 'YH', 'LastName': 'Jo', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Bundang Hospital, Songnam, Korea.'}, {'ForeName': 'Dong-Hyun', 'Initials': 'DH', 'LastName': 'Jang', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Bundang Hospital, Songnam, Korea.'}, {'ForeName': 'Gil Joon', 'Initials': 'GJ', 'LastName': 'Suh', 'Affiliation': 'Department of Emergency Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Taegyun', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Youn-Jung', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Asan Medical Centre, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 138-736, Korea.'}, {'ForeName': 'Seonwoo', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Statistics and Data Centre, Samsung Medical Centre, Seoul, Korea.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'Statistics and Data Centre, Samsung Medical Centre, Seoul, Korea.'}, {'ForeName': 'Ik Joon', 'Initials': 'IJ', 'LastName': 'Jo', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea.'}, {'ForeName': 'Sung Phil', 'Initials': 'SP', 'LastName': 'Chung', 'Affiliation': 'Department of Emergency Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung-Hyuk', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Emergency Medicine, Guro Hospital, Korea University Medical Centre, Seoul, Korea.'}, {'ForeName': 'Tae Gun', 'Initials': 'TG', 'LastName': 'Shin', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea. taegunshin@skku.edu.'}, {'ForeName': 'Won Young', 'Initials': 'WY', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Asan Medical Centre, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 138-736, Korea. wonpia73@naver.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06191-3']
2572,32776103,Catecholaminergic Modulation of Semantic Processing in Sentence Comprehension.,"Catecholamine (CA) function has been widely implicated in cognitive functions that are tied to the prefrontal cortex and striatal areas. The present study investigated the effects of methylphenidate, which is a CA agonist, on the electroencephalogram (EEG) response related to semantic processing using a double-blind, placebo-controlled, randomized, crossover, within-subject design. Forty-eight healthy participants read semantically congruent or incongruent sentences after receiving 20-mg methylphenidate or a placebo while their brain activity was monitored with EEG. To probe whether the catecholaminergic modulation is task-dependent, in one condition participants had to focus on comprehending the sentences, while in the other condition, they only had to attend to the font size of the sentence. The results demonstrate that methylphenidate has a task-dependent effect on semantic processing. Compared to placebo, when semantic processing was task-irrelevant, methylphenidate enhanced the detection of semantic incongruence as indexed by a larger N400 amplitude in the incongruent sentences; when semantic processing was task-relevant, methylphenidate induced a larger N400 amplitude in the semantically congruent condition, which was followed by a larger late positive complex effect. These results suggest that CA-related neurotransmitters influence language processing, possibly through the projections between the prefrontal cortex and the striatum, which contain many CA receptors.",2020,"Compared to placebo, when semantic processing was task-irrelevant, methylphenidate enhanced the detection of semantic incongruence as indexed by a larger N400 amplitude in the incongruent sentences; when semantic processing was task-relevant, methylphenidate induced a larger N400 amplitude in the semantically congruent condition, which was followed by a larger late positive complex effect.","['Forty-eight healthy participants', 'Sentence Comprehension']","['methylphenidate', 'Catecholamine (CA) function', 'placebo']","['read semantically congruent or incongruent sentences', 'semantic processing']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0439853', 'cui_str': 'Congruent'}, {'cui': 'C1321310', 'cui_str': 'Incongruous'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}]",48.0,0.0768094,"Compared to placebo, when semantic processing was task-irrelevant, methylphenidate enhanced the detection of semantic incongruence as indexed by a larger N400 amplitude in the incongruent sentences; when semantic processing was task-relevant, methylphenidate induced a larger N400 amplitude in the semantically congruent condition, which was followed by a larger late positive complex effect.","[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Max Planck Institute for Psycholinguistics, Nijmegen 6525 XD, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hagoort', 'Affiliation': 'Max Planck Institute for Psycholinguistics, Nijmegen 6525 XD, The Netherlands.'}]","Cerebral cortex (New York, N.Y. : 1991)",['10.1093/cercor/bhaa204']
2573,32777552,Evolution of Endoscopic Lesions in Steroid-Refractory Acute Severe Ulcerative Colitis Responding to Infliximab or Cyclosporine.,"BACKGROUND/AIMS
Few data on the evolution of endoscopic findings are available in patients with acute severe ulcerative colitis (ASUC). The aim of this study was to describe this evolution in a prospective cohort.
METHODS
Patients admitted for a steroid-refractory ASUC and included in a randomized trial comparing infliximab and cyclosporine were eligible if they achieved steroid-free clinical remission at day 98. Flexible sigmoidoscopies were performed at baseline, days 7, 42 and 98. Ulcerative colitis endoscopic index of severity (UCEIS) and its sub-scores - vascular pattern, bleeding and ulceration/erosion - were post-hoc calculated. Global endoscopic remission was defined by a UCEIS of 0, and partial endoscopic remission by any UCEIS sub-score of 0.
RESULTS
Among the 55 patients analyzed (29 infliximab and 26 cyclosporine), 49 (83%) had UCEIS ≥6 at baseline at baseline. Partial endoscopic remission rates were higher for bleeding than for vascular pattern and for ulcerations/erosions at day 7 (20% vs. 4% and 5% (n = 55); p = .004 and p=.04), for bleeding and ulceration/erosion than for vascular pattern at day 42 [63% and 65% vs. 33% (n=54); p<.001 for both] and at day 98 [78% and 92% vs. 56% (n = 50); p = .007 and p < .001]. Global endoscopic remission rates at day 98 were higher in patients treated with infliximab than with cyclosporine [73% vs. 25% (n = 26 and 24); p < .001].
CONCLUSION
In steroid-refractory ASUC patients responding to a second-line medical therapy, endoscopic remission process started with bleeding remission and was not achieved in half the patients at day 98 for vascular pattern. Infliximab provided a higher endoscopic remission rate than cyclosporine at day 98.",2020,"Partial endoscopic remission rates were higher for bleeding than for vascular pattern and for ulcerations/erosions at day 7 (20% vs. 4% and 5% (n=55); p=0.004 and p=0.04), for bleeding and ulceration/erosion than for vascular pattern at day 42 [63% and 65% vs. 33% (n=54); p<0.001 for both] and at day 98 [78% and 92% vs. 56% (n=50); p=0.007 and p<0.001].","['patients with acute severe ulcerative colitis (ASUC', 'Patients admitted for a steroid-refractory ASUC and included in a randomized trial comparing']","['infliximab and cyclosporine', 'infliximab or cyclosporine', 'Infliximab', 'infliximab', 'cyclosporine']","['Global endoscopic remission', 'Global endoscopic remission rates', 'Ulcerative colitis endoscopic index of severity (UCEIS) and its sub-scores - vascular pattern, bleeding and ulceration/erosion ', 'Partial endoscopic remission rates', 'ulcerations/erosions', 'endoscopic remission rate', 'bleeding and ulceration/erosion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.13872,"Partial endoscopic remission rates were higher for bleeding than for vascular pattern and for ulcerations/erosions at day 7 (20% vs. 4% and 5% (n=55); p=0.004 and p=0.04), for bleeding and ulceration/erosion than for vascular pattern at day 42 [63% and 65% vs. 33% (n=54); p<0.001 for both] and at day 98 [78% and 92% vs. 56% (n=50); p=0.007 and p<0.001].","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Laharie', 'Affiliation': ""INSERM CIC 1401, Service d'hépato-gastroentérologie et oncologie digestive, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, CHU de Bordeaux, Université de Bordeaux, Bordeaux, France. Electronic address: david.laharie@chu-bordeaux.fr.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bourreille', 'Affiliation': ""Institut des Maladies de l'Appareil Digestif, Hépato-Gastroentérologie, Hôtel-Dieu, CHU de Nantes, Nantes, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Branche', 'Affiliation': ""Service des maladies de l'appareil digestif-Endoscopie digestive, Hôpital Claude Huriez, CHRU de Lille, Lille, France.""}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Allez', 'Affiliation': ""Service d'Hépato-Gastroentérologie, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université Paris VII, Paris, France.""}, {'ForeName': 'Yoram', 'Initials': 'Y', 'LastName': 'Bouhnik', 'Affiliation': 'Gastroentérologie, MICI et Assistance Nutritive, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, Université Paris VII, Clichy, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Filippi', 'Affiliation': ""Service de Gastroentérologie et Nutrition Clinique, Hôpital de l'Archet 2, CHU de Nice, Nice, France.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zerbib', 'Affiliation': ""INSERM CIC 1401, Service d'hépato-gastroentérologie et oncologie digestive, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, CHU de Bordeaux, Université de Bordeaux, Bordeaux, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Savoye', 'Affiliation': 'UMR 1073, Service de Gastroentérologie, Hôpital Charles Nicolle, CHU de Rouen, Normandie Université-Rouen, Rouen, France.'}, {'ForeName': 'Lucine', 'Initials': 'L', 'LastName': 'Vuitton', 'Affiliation': 'Service de Gastroentérologie, Hôpital Jean Minjoz, CHU de Besançon, Besançon, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Moreau', 'Affiliation': 'Service de Gastro-entérologie et Nutrition, Hôpital Rangueil, CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Aurelien', 'Initials': 'A', 'LastName': 'Amiot', 'Affiliation': ""Service d'Hépato-gastroentérologie, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris, Université Créteil, Créteil, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Beaugerie', 'Affiliation': ""Department of Gastroenterology, Institut Pierre Louis d'Epidémiologie et de Santé Publique, INSERM, Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris, Paris, France.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ricart', 'Affiliation': 'Gastroenterology Department, Hospital Clínic, Augus Pi i Sunyer Biomedical Research Institute, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Barcelona, Spain.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dewit', 'Affiliation': ""Service d'Hépato-Gastroentérologie, UCL Saint Luc, Brussels, Belgium.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lopez-Sanroman', 'Affiliation': 'Unidad de EII / IBD Unit, Servicio de Gastroenterología y Hepatología, Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Mathurin', 'Initials': 'M', 'LastName': 'Fumery', 'Affiliation': ""Peritox UMR I-01, Service d'Hépato-Gastroentérologie, CHU Amiens, Amiens, France.""}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Carbonnel', 'Affiliation': ""Service d'Hépato-Gastroentérologie, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, Université Paris Sud 11, Le Kremlin-Bicêtre, France.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Buisson', 'Affiliation': ""INSERM U1071, M2iSH, USC-INRA 2018, 3iHP, Service d'Hépato-Gastroentérologie, CHU Clermont-Ferrand, Université Clermont Auvergne, Clermont-Ferrand, France.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Coffin', 'Affiliation': ""Pôle Maladie Appareil Digestif, Service d'Hépato-Gastroentérologie, Hôpital Louis Mourier, Assistance Publique-Hôpitaux de Paris, Université Paris VII, Colombes, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Roblin', 'Affiliation': 'Service de Gastro-entérologie et Hépatologie, Hôpital Nord, CHU de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'van Assche', 'Affiliation': 'Division of Gastroenterology and Hepatology, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Esteve', 'Affiliation': 'Department of Gastroenterology, Hospital Universitari Mútua de Terrassa, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Terrassa, Spain.'}, {'ForeName': 'Martti', 'Initials': 'M', 'LastName': 'Farkkila', 'Affiliation': 'Clinic of Gastroenterology, Helsinki University Central Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Javier P', 'Initials': 'JP', 'LastName': 'Gisbert', 'Affiliation': 'Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Marteau', 'Affiliation': 'Service Hépato-gastroentérologie, Hôpital Tenon, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Nahon', 'Affiliation': ""Service d'Hépato-gastroentérologie, CHI Le Raincy Montfermeil, Montfermeil, France.""}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'de Vos', 'Affiliation': 'Gastroenterology unit, Ghent University Hospital, Gent, Belgium.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'INSERM U1256 NGERE, Department of Hepato-Gastroenterology, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Mary', 'Affiliation': 'INSERM UMR-S-1153, Equipe ECSTRA, Hôpital Saint-Louis, Paris Diderot University, Paris, France.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.08.001']
2574,32780660,Brigatinib Versus Crizotinib in Advanced ALK Inhibitor-Naive ALK-Positive Non-Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial.,"PURPOSE
Brigatinib, a next-generation anaplastic lymphoma kinase (ALK) inhibitor, demonstrated superior progression-free survival (PFS) and improved health-related quality of life (QoL) versus crizotinib in advanced ALK inhibitor-naive ALK-positive non-small cell lung cancer (NSCLC) at first interim analysis (99 events; median brigatinib follow-up, 11.0 months) in the open-label, phase III ALTA-1L trial (ClinicalTrials.gov identifier: NCT02737501). We report results of the second prespecified interim analysis (150 events).
METHODS
Patients with ALK inhibitor-naive advanced ALK-positive NSCLC were randomly assigned 1:1 to brigatinib 180 mg once daily (7-day lead-in at 90 mg once daily) or crizotinib 250 mg twice daily. The primary end point was PFS as assessed by blinded independent review committee (BIRC). Investigator-assessed efficacy, blood samples for pharmacokinetic assessments, and patient-reported outcomes were also collected.
RESULTS
Two hundred seventy-five patients were randomly assigned (brigatinib, n = 137; crizotinib, n = 138). With median follow-up of 24.9 months for brigatinib (150 PFS events), brigatinib showed consistent superiority in BIRC-assessed PFS versus crizotinib (hazard ratio [HR], 0.49 [95% CI, 0.35 to 0.68]; log-rank P < .0001; median, 24.0 v 11.0 months). Investigator-assessed PFS HR was 0.43 (95% CI, 0.31 to 0.61; median, 29.4 v 9.2 months). No new safety concerns emerged. Brigatinib delayed median time to worsening of global health status/QoL scores compared with crizotinib (HR, 0.70 [95% CI, 0.49 to 1.00]; log-rank P = .049). Brigatinib daily area under the plasma concentration-time curve was not a predictor of PFS (HR, 1.005 [95% CI, 0.98 to 1.031]; P = .69).
CONCLUSION
Brigatinib represents a once-daily ALK inhibitor with superior efficacy, tolerability, and QoL over crizotinib, making it a promising first-line treatment of ALK-positive NSCLC.",2020,"Brigatinib delayed median time to worsening of global health status/QoL scores compared with crizotinib (HR, 0.70 [95% CI, 0.49 to 1.00]; log-rank P = .049).","['Patients with ALK inhibitor-naive advanced ALK-positive NSCLC', 'Two hundred seventy-five patients were randomly assigned (brigatinib, n = 137; crizotinib, n = 138', 'Non-Small Cell Lung Cancer']","['brigatinib 180 mg once daily (7-day lead-in at 90 mg once daily) or crizotinib 250 mg twice daily', 'Brigatinib Versus Crizotinib in Advanced ALK Inhibitor-Naive ALK-Positive']","['Brigatinib delayed median time to worsening of global health status/QoL scores', 'superior progression-free survival (PFS) and improved health-related quality of life (QoL', 'Brigatinib daily area under the plasma concentration-time curve']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0252409', 'cui_str': 'ALK Tyrosine Kinase Receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4287815', 'cui_str': 'brigatinib'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}]","[{'cui': 'C4530661', 'cui_str': 'brigatinib 180 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3204577', 'cui_str': 'crizotinib 250 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4287815', 'cui_str': 'brigatinib'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0252409', 'cui_str': 'ALK Tyrosine Kinase Receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C4287815', 'cui_str': 'brigatinib'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",275.0,0.347815,"Brigatinib delayed median time to worsening of global health status/QoL scores compared with crizotinib (HR, 0.70 [95% CI, 0.49 to 1.00]; log-rank P = .049).","[{'ForeName': 'D Ross', 'Initials': 'DR', 'LastName': 'Camidge', 'Affiliation': 'University of Colorado Cancer Center, Aurora, CO.'}, {'ForeName': 'Hye Ryun', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Myung-Ju', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'James C H', 'Initials': 'JCH', 'LastName': 'Yang', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ji-Youn', 'Initials': 'JY', 'LastName': 'Han', 'Affiliation': 'National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Maximilian J', 'Initials': 'MJ', 'LastName': 'Hochmair', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Krankenhaus Nord-Klinik Floridsdorf, Vienna, Austria.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Cheongju, South Korea.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Delmonte', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), IRCCS, Meldola, Italy.'}, {'ForeName': 'Maria Rosario', 'Initials': 'MR', 'LastName': 'García Campelo', 'Affiliation': 'Complejo Hospitalario Universitario A Coruna, Coruna, Spain.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Griesinger', 'Affiliation': 'Pius-Hospital Oldenburg, University of Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Califano', 'Affiliation': 'The Christie NHS Foundation Trust and Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Spira', 'Affiliation': 'Virginia Cancer Specialists and US Oncology Research, The Woodlands, TX.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Gettinger', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Tiseo', 'Affiliation': 'University Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Huamao M', 'Initials': 'HM', 'LastName': 'Lin', 'Affiliation': 'Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hanley', 'Affiliation': 'Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Quanhong', 'Initials': 'Q', 'LastName': 'Ni', 'Affiliation': 'Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Pingkuan', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Millennium Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Popat', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00505']
2575,32783644,Lasmiditan in patients with common migraine comorbidities: a post hoc efficacy and safety analysis of two phase 3 randomized clinical trials.,"OBJECTIVE
Determine whether common migraine comorbidities affect the efficacy and safety of lasmiditan, a 5-HT 1F receptor agonist approved in the United States for the acute treatment of migraine.
METHODS
In SPARTAN and SAMURAI (double-blind Phase 3 clinical trials), patients with migraine were randomized to oral lasmiditan 50 mg (SPARTAN only), 100mg, 200 mg, or placebo. Lasmiditan increased the proportion of pain-free and most bothersome symptom (MBS)-free patients at 2 h after dose compared with placebo. Most common treatment-emergent adverse events (TEAEs) were dizziness, paraesthesia, somnolence, fatigue, nausea, muscular weakness, and hypoesthesia. Based upon literature review of common migraine comorbidities, Anxiety, Allergy, Bronchial, Cardiac, Depression, Fatigue, Gastrointestinal, Hormonal, Musculoskeletal/Pain, Neurological, Obesity, Sleep, and Vascular Comorbidity Groups were created. Using pooled results, efficacy and TEAEs were assessed to compare patients with or without a given common migraine comorbidity. To compare treatment groups, p -values were calculated for treatment-by-subgroup interaction, based on logistic regression with treatment-by-comorbidity condition status (Yes/No) as the interaction term; study, treatment group, and comorbidity condition status (Yes/No) were covariates. Differential treatment effect based upon comorbidity status was also examined. Trial registration at clinicaltrials.gov: SAMURAI (NCT02439320) and SPARTAN (NCT02605174).
RESULTS
Across all the Comorbidity Groups, with the potential exception of fatigue, treatment-by-subgroup interaction analyses did not provide evidence of a lasmiditan-driven lasmiditan versus placebo differential treatment effect dependent on Yes versus No comorbidity subgroup for either efficacy or TEAE assessments.
CONCLUSIONS
The efficacy and safety of lasmiditan for treatment of individual migraine attacks appear to be independent of comorbid conditions.",2020,Lasmiditan increased the proportion of pain-free and most bothersome symptom (MBS)-free patients at 2 hours after dose compared with placebo.,"['patients with or without a given common migraine comorbidity', 'patients with migraine', 'patients with common migraine comorbidities']","['oral lasmiditan 50\u2009mg (SPARTAN only), 100\u2009mg, 200\u2009mg, or placebo', 'lasmiditan', 'placebo']","['dizziness, paraesthesia, somnolence, fatigue, nausea, muscular weakness, and hypoesthesia', 'proportion of pain-free and most bothersome symptom']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338480', 'cui_str': 'Migraine without aura'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0151786', 'cui_str': 'Muscle weakness'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.166168,Lasmiditan increased the proportion of pain-free and most bothersome symptom (MBS)-free patients at 2 hours after dose compared with placebo.,"[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Clemow', 'Affiliation': 'Corporate Center, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Simin K', 'Initials': 'SK', 'LastName': 'Baygani', 'Affiliation': 'Corporate Center, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Hauck', 'Affiliation': 'Corporate Center, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Cory B', 'Initials': 'CB', 'LastName': 'Hultman', 'Affiliation': 'Corporate Center, Eli Lilly and Company, Indianapolis, IN, USA.'}]",Current medical research and opinion,['10.1080/03007995.2020.1808780']
2576,32795925,Relationship between antofloxacin concentration and QT prolongation and estimation of the possible false-positive rate.,"PURPOSE
To elucidate the relationship between antofloxacin (AT) plasma concentration and QT interval prolongation, compare the effects of different correction and analytical methods on conclusions, and estimate the possible false-positive rate in thorough QT (TQT) studies.
METHODS
Twenty-four healthy Chinese volunteers from a four-period crossover TQT study orally received 200 mg/d AT, 400 mg/d AT, 400 mg/d moxifloxacin, and a placebo in a random order for 5 d for each. QT interval samples were collected on d 1 and d 5. Population models were established describing the relationship between QT and AT concentration. The yardstick from ICH E14 guidelines was used to measure the effect of drugs on QT prolongation both in biostatistical and modeling analyses. A possible false-positive rate was estimated by constructing a 1000-time bootstrap to obtain the rate-of-difference values between d 1 and d 5 over 5 ms in the placebo period.
RESULTS
In the modeling analysis, the QT prolongation estimate at the mean maximal concentration of AT (4.51 μg/mL) was 3.84 ms, and its upper bound of the one-sided 95 % CI was 7.04 ms, which showed a negative effect on QT interval prolongation. The estimation for the false-positive rate was 31 % in this study.
CONCLUSION
The effect of AT on QT interval prolongation may not have been significant at the dosage of 400 mg. Baseline and placebo adjustments were necessary in TQT studies. Population modeling has demonstrated clear superiority in making full use of data to accurately analyze the relationship between drugs and QT intervals.",2020,"In the modeling analysis, the QT prolongation estimate at the mean maximal concentration of AT (4.51 μg/mL) was 3.84 ms, and its upper bound of the one-sided 95 % CI was 7.04 ms, which showed a negative effect on QT interval prolongation.",['Twenty-four healthy Chinese volunteers from a four-period crossover'],"['TQT study orally received 200\u2009mg/d AT, 400\u2009mg/d AT, 400\u2009mg/d moxifloxacin, and a placebo', 'placebo']","['false-positive rate', 'antofloxacin concentration and QT prolongation and estimation of the possible false-positive rate', 'antofloxacin (AT) plasma concentration and QT interval prolongation', 'QT interval samples', 'QT interval prolongation']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C2002223', 'cui_str': 'antofloxacin'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C2002223', 'cui_str': 'antofloxacin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",24.0,0.0861305,"In the modeling analysis, the QT prolongation estimate at the mean maximal concentration of AT (4.51 μg/mL) was 3.84 ms, and its upper bound of the one-sided 95 % CI was 7.04 ms, which showed a negative effect on QT interval prolongation.","[{'ForeName': 'Li-Yu', 'Initials': 'LY', 'LastName': 'Liang', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Ying-Chun', 'Initials': 'YC', 'LastName': 'He', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Yun-Fei', 'Initials': 'YF', 'LastName': 'Li', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Feng-Yan', 'Initials': 'FY', 'LastName': 'Xu', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Lu-Jin', 'Initials': 'LJ', 'LastName': 'Li', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Ji-Han', 'Initials': 'JH', 'LastName': 'Huang', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: huangjihan@shutcm.edu.cn.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: kunwang@139.com.'}, {'ForeName': 'Qing-Shan', 'Initials': 'QS', 'LastName': 'Zheng', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: qingshan.zheng@drugchina.net.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.110619']
2577,32800511,Efficacy and Safety of Sacubitril/Valsartan by Dose Level Achieved in the PIONEER-HF Trial.,"OBJECTIVES
This study sought to evaluate the efficacy and safety of sacubitril/valsartan according to dose level achieved in the PIONEER-HF (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode) trial.
BACKGROUND
In patients hospitalized for acute decompensated heart failure (ADHF), in-hospital initiation and continuation of sacubitril/valsartan as compared with enalapril is well tolerated, achieves a greater reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP), and reduces the risk of cardiovascular death or rehospitalization for HF through 8 weeks. However, not all patients achieve the target dose of sacubitril/valsartan, and its efficacy and safety in such patients are of interest.
METHODS
PIONEER-HF was a randomized, double-blind, active-controlled trial of sacubitril/valsartan versus enalapril in 881 patients stabilized during hospitalization for ADHF. Blinded study medication was administered for 8 weeks, with initial dosing selected based on the systolic blood pressure at randomization and titrated toward a target of sacubitril/valsartan 97/103 mg twice daily, or enalapril 10 mg twice daily, with an algorithm based on systolic blood pressure and the investigator's assessment of tolerability.
RESULTS
At 4 weeks, 199 (55%) patients allocated to sacubitril/valsartan and 211 (60%) patients allocated to enalapril were dispensed the target dose. Baseline characteristics were similar in the 2 treatment groups within each dose level. There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
CONCLUSIONS
In hemodynamically stabilized patients with ADHF, the efficacy and safety of sacubitril/valsartan are generally consistent across dose levels. (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode [PIONEER-HF]; NCT02554890).",2020,"There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
","['patients hospitalized for acute decompensated heart failure (ADHF), in-hospital initiation and continuation of sacubitril', 'Patients', '881 patients stabilized during hospitalization for ADHF']","['valsartan', 'Sacubitril/Valsartan Versus Enalapril', 'enalapril', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'sacubitril/valsartan 97/103\xa0mg twice daily, or enalapril', 'sacubitril/valsartan versus enalapril']","['Efficacy and Safety', 'cardiovascular death or rehospitalization for heart failure', 'NT-proBNP', 'efficacy and safety', 'systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C4033447', 'cui_str': 'sacubitril'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",881.0,0.206586,"There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Berg', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: dberg1@bwh.harvard.edu.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Pinney', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Carol I', 'Initials': 'CI', 'LastName': 'Duffy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JACC. Heart failure,['10.1016/j.jchf.2020.06.008']
2578,32805133,Three-Year Outcomes of Bariatric Surgery in Patients With Obesity and Hypertension : A Randomized Clinical Trial.,"BACKGROUND
Midterm effects of bariatric surgery on patients with obesity and hypertension remain uncertain.
OBJECTIVE
To determine the 3-year effects of Roux-en-Y gastric bypass (RYGB) on blood pressure (BP) compared with medical therapy (MT) alone.
DESIGN
Randomized clinical trial. (ClinicalTrials.gov: NCT01784848).
SETTING
Investigator-initiated study at Heart Hospital (HCor), São Paulo, Brazil.
PARTICIPANTS
Patients with hypertension receiving at least 2 medications at maximum doses or more than 2 medications at moderate doses and with a body mass index (BMI) between 30.0 and 39.9 kg/m 2 were randomly assigned (1:1 ratio).
INTERVENTION
RYGB plus MT or MT alone.
MEASUREMENTS
The primary outcome was at least a 30% reduction in total number of antihypertensive medications while maintaining BP less than 140/90 mm Hg. Key secondary outcomes were number of antihypertensive medications, hypertension remission, and BP control according to current guidelines (<130/80 mm Hg).
RESULTS
Among 100 patients (76% female; mean BMI, 36.9 kg/m 2 [SD, 2.7]), 88% from the RYGB group and 80% from the MT group completed follow-up. At 3 years, the primary outcome occurred in 73% of patients from the RYGB group compared with 11% of patients from the MT group (relative risk, 6.52 [95% CI, 2.50 to 17.03]; P < 0.001). Of the randomly assigned participants, 35% and 31% from the RYGB group and 2% and 0% from the MT group achieved BP less than 140/90 mm Hg and less than 130/80 mm Hg without medications, respectively. Median (interquartile range) number of medications in the RYGB and MT groups at 3 years was 1 (0 to 2) and 3 (2.8 to 4), respectively ( P < 0.001). Total weight loss was 27.8% and -0.1% in the RYGB and MT groups, respectively. In the RYGB group, 13 patients developed hypovitaminosis B 12 and 2 patients required reoperation.
LIMITATION
Single-center, nonblinded trial.
CONCLUSION
RYGB is an effective strategy for midterm BP control and hypertension remission, with fewer medications required in patients with hypertension and obesity.
PRIMARY FUNDING SOURCE
Ethicon, represented in Brazil by Johnson & Johnson do Brasil.",2020,"Total weight loss was 27.8% and -0.1% in the RYGB and MT groups, respectively.","['100 patients (76% female; mean BMI, 36.9 kg/m 2 [SD, 2.7]), 88% from the RYGB group and 80% from the MT group completed follow-up', 'patients with obesity and hypertension remain uncertain', 'Investigator-initiated study at Heart Hospital (HCor), São Paulo, Brazil', 'Patients With Obesity and Hypertension', 'patients with hypertension and obesity', 'Patients with hypertension receiving at least 2 medications at maximum doses or more than 2 medications at moderate doses and with a body mass index (BMI) between 30.0 and 39.9 kg/m 2']","['Bariatric Surgery', 'Roux-en-Y gastric bypass (RYGB', 'bariatric surgery', 'RYGB', 'RYGB plus MT or MT alone', 'medical therapy (MT) alone']","['Total weight loss', 'Median (interquartile range) number of medications', 'number of antihypertensive medications, hypertension remission, and BP control according to current guidelines', 'blood pressure (BP', 'total number of antihypertensive medications while maintaining BP less', 'BP less', 'reoperation']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}]",100.0,0.207437,"Total weight loss was 27.8% and -0.1% in the RYGB and MT groups, respectively.","[{'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Schiavon', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil (C.A.S., E.V.S., R.N.S., L.P.D., J.D.O., R.H.M., A.B.C.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, Massachusetts (D.L.B.).""}, {'ForeName': 'Dimas', 'Initials': 'D', 'LastName': 'Ikeoka', 'Affiliation': 'HCor Intensive Unit, São Paulo, Brazil (D.I.).'}, {'ForeName': 'Eliana V', 'Initials': 'EV', 'LastName': 'Santucci', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil (C.A.S., E.V.S., R.N.S., L.P.D., J.D.O., R.H.M., A.B.C.).'}, {'ForeName': 'Renato Nakagawa', 'Initials': 'RN', 'LastName': 'Santos', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil (C.A.S., E.V.S., R.N.S., L.P.D., J.D.O., R.H.M., A.B.C.).'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil (C.A.S., E.V.S., R.N.S., L.P.D., J.D.O., R.H.M., A.B.C.).'}, {'ForeName': 'Juliana D', 'Initials': 'JD', 'LastName': 'Oliveira', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil (C.A.S., E.V.S., R.N.S., L.P.D., J.D.O., R.H.M., A.B.C.).'}, {'ForeName': 'Rachel Helena V', 'Initials': 'RHV', 'LastName': 'Machado', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil (C.A.S., E.V.S., R.N.S., L.P.D., J.D.O., R.H.M., A.B.C.).'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Halpern', 'Affiliation': 'HCor Surgical Center, São Paulo, Brazil (H.H., F.L.M., P.M.N.).'}, {'ForeName': 'Frederico L J', 'Initials': 'FLJ', 'LastName': 'Monteiro', 'Affiliation': 'HCor Surgical Center, São Paulo, Brazil (H.H., F.L.M., P.M.N.).'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Noujaim', 'Affiliation': 'HCor Surgical Center, São Paulo, Brazil (H.H., F.L.M., P.M.N.).'}, {'ForeName': 'Ricardo V', 'Initials': 'RV', 'LastName': 'Cohen', 'Affiliation': 'Oswaldo Cruz German Hospital, São Paulo, Brazil (R.V.C.).'}, {'ForeName': 'Marcio G', 'Initials': 'MG', 'LastName': 'de Souza', 'Affiliation': 'Dante Pazzanese Institute of Cardiology, São Paulo, Brazil (M.G.D.).'}, {'ForeName': 'Celso', 'Initials': 'C', 'LastName': 'Amodeo', 'Affiliation': 'Federal University of São Paulo, São Paulo, Brazil (C.A.).'}, {'ForeName': 'Luiz A', 'Initials': 'LA', 'LastName': 'Bortolotto', 'Affiliation': 'University of São Paulo Medical School, São Paulo, Brazil (L.A.B., L.F.D.).'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Albert Einstein Hospital, São Paulo, Brazil (O.B.).'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil (C.A.S., E.V.S., R.N.S., L.P.D., J.D.O., R.H.M., A.B.C.).'}, {'ForeName': 'Luciano F', 'Initials': 'LF', 'LastName': 'Drager', 'Affiliation': 'University of São Paulo Medical School, São Paulo, Brazil (L.A.B., L.F.D.).'}]",Annals of internal medicine,['10.7326/M19-3781']
2579,32808383,"Effect of a technology-supported physical activity intervention on health-related quality of life, sleep, and processes of behavior change in cancer survivors: A randomized controlled trial.","OBJECTIVES
This pilot trial tested the effect of adding a multi-level, technology-based physical activity intervention module to a standard survivorship care plan for breast and colorectal cancer survivors. The objective of this analysis was to determine whether the physical activity module improved health-related quality of life, sleep, and factors key to lasting behavior change (eg, social support, self-efficacy).
METHODS
Breast and colorectal cancer survivors (n = 50) were enrolled alongside a support partner. Survivors were assigned to receive a standard survivorship care plan either alone or augmented by a 12-week multi-component physical activity module. The module included a Fitbit tracker (with the physical activity data integrated into the electronic health record for clinician review) and customized email feedback. Physical activity was measured using the ActiGraph GT3X+. Psychosocial outcomes included the SF-36, FACT, ISEL, PROMIS sleep measures, and physical activity beliefs. Data were analyzed using linear mixed modeling.
RESULTS
Cancer survivors were aged 54.4 ± 11.2 years and were 2.0 ± 1.5 years from diagnosis. Relative to comparison, the intervention was associated with moderate-to-large improvements in physical health (effect size: d = 0.39, 95% CI = 0.0, 0.78), mental health (d = 0.59, 95% CI = 0.19, 0.99), sleep impairment (d = 0.62, 95% CI = -1.02, -0.22), and exercise self-efficacy (d = 0.60, 95% CI = 0.20, 1.0).
CONCLUSIONS
The intervention delivered meaningful improvements in survivors' quality of life, social support, and sleep impairment. If replicated in a larger sample, adding a technology-supported physical activity module to survivorship care plans may be a practical strategy for supporting healthy survivorship.
TRIAL REGISTRATION
ClinicalTrials.gov#: NCT02677389.",2020,"Relative to comparison, the intervention was associated with moderate-to-large improvements in physical health (effect size: d=0.39, 95% CI=0.0,0.78), mental health (d=0.59, 95% CI=0.19,0.99), sleep impairment (d=0.62, 95% CI=-1.02,-0.22), and exercise self-efficacy (d=0.60, 95% CI=0.20,1.0).
","['Cancer survivors were aged 54.4±11.2\u2009years and were 2.0±1.5\u2009years from diagnosis', 'breast and colorectal cancer survivors', 'cancer survivors', 'Breast and colorectal cancer survivors (n=50) were enrolled alongside a support partner']","['technology-supported physical activity intervention', 'multi-level, technology-based physical activity intervention module to a standard survivorship care plan', 'standard survivorship care plan either alone or augmented by a 12-week multi-component physical activity module', 'Fitbit tracker (with the physical activity data integrated into the electronic health record for clinician review) and customized email feedback']","['sleep impairment', 'exercise self-efficacy', 'health-related quality of life, sleep, and processes of behavior change', 'Physical activity', 'health-related quality of life, sleep, and factors key to lasting behavior change (e.g., social support, self-efficacy', ""survivors' quality of life, social support, and sleep impairment"", 'mental health', 'SF-36, FACT, ISEL, PROMIS sleep measures, and physical activity beliefs', 'physical health']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.120099,"Relative to comparison, the intervention was associated with moderate-to-large improvements in physical health (effect size: d=0.39, 95% CI=0.0,0.78), mental health (d=0.59, 95% CI=0.19,0.99), sleep impairment (d=0.62, 95% CI=-1.02,-0.22), and exercise self-efficacy (d=0.60, 95% CI=0.20,1.0).
","[{'ForeName': 'Somya', 'Initials': 'S', 'LastName': 'Rastogi', 'Affiliation': 'Department of Kinesiology, University of Wisconsin, Madison, Wisconsin, USA.'}, {'ForeName': 'Amye J', 'Initials': 'AJ', 'LastName': 'Tevaarwerk', 'Affiliation': 'Department of Medicine, University of Wisconsin, Madison, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sesto', 'Affiliation': 'Department of Medicine, University of Wisconsin, Madison, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Van Remortel', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Preshita', 'Initials': 'P', 'LastName': 'Date', 'Affiliation': 'Department of Anesthesiology, Montefiore Medical Center, The Bronx, New York, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Gangnon', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin, Madison, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Thraen-Borowski', 'Affiliation': 'Department of Kinesiology, Loras College, Dubuque, Iowa, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cadmus-Bertram', 'Affiliation': 'Department of Kinesiology, University of Wisconsin, Madison, Wisconsin, USA.'}]",Psycho-oncology,['10.1002/pon.5524']
2580,32807727,Patterns of Cancer Progression of Metastatic Hormone-sensitive Prostate Cancer in the ECOG3805 CHAARTED Trial.,"BACKGROUND
ECOG3805 is a randomized trial of testosterone suppression with or without docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC). Deeper prostate-specific antigen (PSA) suppression is prognostic for outcome. However, the concordance of PSA rise and radiographic progression has not been examined previously in mHSPC, whereas this has been reported in metastatic castration-resistant prostate cancer.
OBJECTIVE
To determine the patterns of progression by PSA and radiographic parameters in patients in ECOG3805.
DESIGN, SETTING, AND PARTICIPANTS
We conducted a retrospective analysis of all patients in ECOG3805. Patients were classified according to the PSA level at progression (whether PSA level was below 2.0 ng/mL or not) and the type of progression event in the study (either PSA progression as defined by the study with or without clinical progression, or clinical progression alone). Baseline demographics, clinical outcomes, and patterns of progression were compared between the groups.
RESULTS AND LIMITATIONS
One in eight patients had clinical progression below a PSA level of 2 ng/mL, and approximately 25% developed clinical progression in the absence of confirmed PSA progression. Overall survival from randomization was shorter in patients with clinical progression without confirmed PSA progression than in patients with PSA progression alone as the first progression. Patient demographics at study entry were not predictive of the pattern of progression. Study limitations include its retrospective and post hoc nature.
CONCLUSIONS
Clinical progression prior to PSA rise or at low PSA levels is a relatively frequent phenomenon in mHSPC and is associated with poorer overall survival. Further biological and clinical studies of these patients are warranted.
PATIENT SUMMARY
Reliance on prostate-specific antigen (PSA) alone is an inadequate strategy to monitor patients undergoing treatment for metastatic hormone-sensitive prostate cancer. Prostate cancer can get worse on scans even with low PSA and/or no or small changes in PSA. Imaging should be added to PSA testing to monitor patients with metastatic prostate cancer.",2020,Overall survival from randomization was shorter in patients with clinical progression without confirmed PSA progression than in patients with PSA progression alone as the first progression.,"['Patients were classified according to the PSA level at progression (whether PSA level was below 2.0\u2009ng/mL or not) and the type of progression event in the study (either PSA progression as defined by the study with or without clinical progression, or clinical progression alone', 'patients with metastatic prostate cancer', 'all patients in ECOG3805', 'patients undergoing treatment for metastatic hormone-sensitive prostate cancer', 'metastatic hormone-sensitive prostate cancer (mHSPC', 'patients in ECOG3805']",['testosterone suppression with or without docetaxel'],"['clinical progression below a PSA level', 'Overall survival', 'overall survival', 'Baseline demographics, clinical outcomes, and patterns of progression', 'clinical progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",,0.0323714,Overall survival from randomization was shorter in patients with clinical progression without confirmed PSA progression than in patients with PSA progression alone as the first progression.,"[{'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Bryce', 'Affiliation': 'Division of Hematology and Medical Oncology, Mayo Clinic, Phoenix, AZ, USA. Electronic address: Bryce.alan@mayo.edu.'}, {'ForeName': 'Yu Hui', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Carbone Cancer Center, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Department of Oncology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Jarrard', 'Affiliation': 'Department of Urology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Garcia', 'Affiliation': 'Department of Medicine, Case Comprehensive Cancer Center, Cleveland, OH, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dreicer', 'Affiliation': 'Nevada Cancer Research Foundation, Las Vegas, NV, USA.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Division of Hematology Oncology, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Mario Alfredo', 'Initials': 'MA', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Urology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'Nevada Cancer Research Foundation, Las Vegas, NV, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'DiPaola', 'Affiliation': 'College of Medicine, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Harshman', 'Affiliation': 'Department of Medicine, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Sweeney', 'Affiliation': 'Division of Hematology/Oncology, University of Virginia Cancer Center, USA.'}]",European urology oncology,['10.1016/j.euo.2020.07.001']
2581,32856448,A comparative study of combined intravenous and topical administration of tranexamic acid with topical tranexamic acid alone for blood loss reduction after primary uncemented total hip arthroplasty.,"The aim of the present study was to evaluate the efficacy of topical versus combined (intravenous + topical) tranexamic acid (TXA) to reduce perioperative blood loss after uncemented primary total hip arthroplasty (THA). Seventy-five patients were randomized in three comparable experimental groups: 1) topical TXA (3 g in 50 ml of saline solution); 2) intravenous + topical TXA (3 g topical + 2 g in 100 ml of saline solution intravenously); 3) controls. Pre- and post-operative hemoglobin (Hb) levels and hematocrit (Hct) values along with the rate of blood transfusion in the 3 groups were compared. The intravenous + topical TXA group demonstrated higher Hb levels and Hct values at postoperative day one (Hb = p <0.05, Hct = p <0.001), postoperative day three (Hb = p <0.05, Hct = p <0.001), and discharge (Hct = p <0.01) compared to the control group. The intravenous + topical group had a lower transfusion rate compared to the control group (0% vs 20%, p = 0.014). With the numbers available, no difference in postoperative Hb level and transfusion rate emerged between topical TXA and control group.",2020,"The intravenous + topical group had a lower transfusion rate compared to the control group (0% vs 20%, p = 0.014).","['after uncemented primary total hip arthroplasty (THA', 'Seventy-five patients', 'after primary uncemented total hip arthroplasty']","['tranexamic acid with topical tranexamic acid alone', 'intravenous + topical TXA', 'Pre- and post-operative hemoglobin', 'topical versus combined (intravenous + topical) tranexamic acid (TXA', 'topical TXA']","['transfusion rate', 'perioperative blood loss', 'postoperative Hb level and transfusion rate', 'Hb levels and Hct values', 'blood loss reduction', 'Hb) levels and hematocrit (Hct) values']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0039245', 'cui_str': 'Tacrine'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",75.0,0.0612338,"The intravenous + topical group had a lower transfusion rate compared to the control group (0% vs 20%, p = 0.014).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rizzo', 'Affiliation': 'Department of Public Health - Section of Orthopaedic Surgery - ""Federico II"" University - Naples, Via Sergio Pansini 5, 80131 Naples, Italy.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Russo', 'Affiliation': 'Department of Public Health - Section of Orthopaedic Surgery - ""Federico II"" University - Naples, Via Sergio Pansini 5, 80131 Naples, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guarino', 'Affiliation': 'Department of Public Health - Section of Orthopaedic Surgery - ""Federico II"" University - Naples, Via Sergio Pansini 5, 80131 Naples, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Izzo', 'Affiliation': 'Department of Public Health - Section of Orthopaedic Surgery - ""Federico II"" University - Naples, Via Sergio Pansini 5, 80131 Naples, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mariconda', 'Affiliation': 'Department of Public Health - Section of Orthopaedic Surgery - ""Federico II"" University - Naples, Via Sergio Pansini 5, 80131 Naples, Italy.'}]",Journal of biological regulators and homeostatic agents,[]
2582,32857481,Effect of menopausal hormone therapy on proteins associated with senescence and inflammation.,"BACKGROUND
Estrogen may inhibit cell senescence that contributes to age-related disorders. This study determined the effects of menopausal hormone treatments on circulating levels of markers of cell senescence.
METHODS
Growth differentiation factor 15 (GDF15), tumor necrosis factor receptor 1 (TNFR1), FAS, and macrophage inflammatory protein 1α (MIP1α) were measured in serum using multiplexed bead-based assays and compared among menopausal women participating in the Kronos Early Estrogen Prevention Study randomized to either placebo (n = 38), oral conjugated equine estrogen (oCEE, n = 37), or transdermal 17β-estradiol (tE2, n = 34). Serum levels of the senescent markers for each treatment were compared to placebo 36 months after randomization using the Wilcoxon rank sum test.
RESULTS
Serum levels of GDF15, TNFR1, and FAS, but not MIP1α, were lower in both the oCEE and tE2 groups compared to placebo. The difference in levels between treatment and placebo for GDF15, TNFR1, and FAS were greater for oCEE [-108 pg/mL (p = .008), -234 pg/mL (p = .0006), and -1374 pg/mL (p < .0001), respectively] than for tE2 [-76 pg/mL (p = .072), -105 pg/mL (p = .076), and -695 pg/mL (p = .036), respectively]. Additionally, TNFR1 showed a positive association with time past menopause (correlation = 0.255, p = .019).
CONCLUSIONS
Circulating levels of some markers of cell senescence were lower in menopausal women treated with oCEE and tE2 compared to placebo. Differences in the magnitude of effect of the two active treatments may reflect the differences in circulating levels of estrogen metabolites due to formulation and mode of delivery. These data generate new hypotheses with regard to the effects of menopause on the biology of aging.",2020,"RESULTS
Serum levels of GDF15, TNFR1, and FAS, but not MIP1α, were lower in both the oCEE and tE2 groups compared to placebo.",['menopausal women participating in the Kronos Early Estrogen Prevention Study randomized to either'],"['TNFR1', 'placebo', 'menopausal hormone therapy', 'oCEE', 'oral conjugated equine estrogen (oCEE, n\xa0=\xa037), or transdermal 17β-estradiol', 'menopausal hormone treatments']","['GDF15, TNFR1, and FAS', 'Serum levels', 'cell senescence', 'Serum levels of GDF15, TNFR1, and FAS', 'senescence and inflammation', 'Growth differentiation factor 15 (GDF15), tumor necrosis factor receptor 1 (TNFR1), FAS, and macrophage inflammatory protein 1α (MIP1α', 'circulating levels of markers of cell senescence']","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1453722', 'cui_str': 'TNFRSF1A protein, human'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C1453722', 'cui_str': 'TNFRSF1A protein, human'}, {'cui': 'C0015683', 'cui_str': 'Fatty-acid synthase'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007581', 'cui_str': 'Senescence, Cellular'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.255534,"RESULTS
Serum levels of GDF15, TNFR1, and FAS, but not MIP1α, were lower in both the oCEE and tE2 groups compared to placebo.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Faubion', 'Affiliation': 'Department of Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'White', 'Affiliation': 'Robert and Arlene Kogod Center on Aging, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Brett J', 'Initials': 'BJ', 'LastName': 'Peterson', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Geske', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Nathan K', 'Initials': 'NK', 'LastName': 'LeBrasseur', 'Affiliation': 'Robert and Arlene Kogod Center on Aging, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Marissa J', 'Initials': 'MJ', 'LastName': 'Schafer', 'Affiliation': 'Robert and Arlene Kogod Center on Aging, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Mielke', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Miller', 'Affiliation': 'Department of Surgery, Mayo Clinic, Rochester, MN, USA.'}]",Physiological reports,['10.14814/phy2.14535']
2583,32858229,A multi-modal virtual reality treadmill intervention for enhancing mobility and cognitive function in people with multiple sclerosis: Protocol for a randomized controlled trial.,"BACKGROUND
Gait and cognitive impairments are common in individuals with Multiple Sclerosis (MS) and can interfere with everyday function. Those with MS have difficulties executing cognitive tasks and walking simultaneously, a reflection of dual-task interference. Therefore, dual-task training may improve functional ambulation. Additionally, using technology such as virtual reality can provide personalized rehabilitation while mimicking real-world environments. The purpose of this randomized controlled trial is to establish the benefits of a combined cognitive-motor virtual reality training on MS symptoms compared to conventional treadmill training.
METHODS
This study will be a single-blinded, two arm RCT with a six-week intervention period. 144 people with MS will be randomized into a treadmill training alone group or treadmill training with virtual reality group. Both groups will receive 18 sessions of training while walking on a treadmill, with the virtual reality group receiving feedback from the virtual system. Primary outcome measures include dual-task gait speed and information processing speed, which will be measured prior to training, one-week post-training, and three months following training.
DISCUSSION
This study will provide insight into the ability of a multi-modal cognitive-motor intervention to reduce dual-task cost and to enhance information processing speed in those with MS. This is one of the first studies that is powered to understand whether targeted dual-task training can improve MS symptoms and increase functional ambulation. We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.",2020,We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.,"['people with multiple sclerosis', '144 people with MS', 'individuals with Multiple Sclerosis (MS']","['conventional treadmill training', 'combined cognitive-motor virtual reality training', 'modal virtual reality treadmill intervention', 'treadmill training alone group or treadmill training with virtual reality group', 'dual-task training', 'training while walking on a treadmill, with the virtual reality group receiving feedback from the virtual system']","['dual-task gait speed and information processing speed, which will be measured prior to training, one-week post-training, and three months following training', 'mobility and cognitive function', 'functional ambulation', 'dual-task gait speed and information processing speed', 'MS symptoms and increase functional ambulation', 'MS symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0376392', 'cui_str': 'Virtual Systems'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",144.0,0.0521126,We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.,"[{'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Hsieh', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA; Illinois Multiple Sclerosis Research Collaborative, Interdisciplinary Health Science Institute, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mirelman', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Neurology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shema-Shiratzky', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Galperin', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Regev', 'Affiliation': 'Neuroimmunology and Multiple Sclerosis Unit of the Neurology Division, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Schmitz-Hübsch', 'Affiliation': 'NeuroCure, Charité - Universitaetsmedizin Berlin, Berlin, Germany; Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité - Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karni', 'Affiliation': 'Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Neurology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Neuroimmunology and Multiple Sclerosis Unit of the Neurology Division, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Paul', 'Affiliation': 'NeuroCure, Charité - Universitaetsmedizin Berlin, Berlin, Germany; Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité - Universitaetsmedizin Berlin, Berlin, Germany; Department of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Devos', 'Affiliation': 'Laboratory for Advanced Rehabilitation Research in Simulation, Department of Physical Therapy and Rehabilitation Science, School of Health Professions, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Sosnoff', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA; Illinois Multiple Sclerosis Research Collaborative, Interdisciplinary Health Science Institute, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': ""Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Rush Alzheimer's Disease Center and Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA. Electronic address: jhausdor@tlvmc.gov.il.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106122']
2584,32858247,"Control of Pain in Intravitreal Injections: Evaluation of Combination Topical Anesthetics and Non-steroidal Anti-inflammatory Drops: A Randomized, Placebo-Controlled Clinical Trial.",,2020,The addition of topical NSAID to proparacaine drops and lidocaine ophthalmic gel had negligible effect on subjective pain.,['pain control following intravitreal injection'],"['proparacaine', 'Combination Topical Anesthetics and Non-Steroidal Anti-Inflammatory Drops (NSAIDs', 'lidocaine ophthalmic gel', 'NSAID drops', 'placebo']",['subjective pain'],"[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}]","[{'cui': 'C0072510', 'cui_str': 'proparacaine'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C2366224', 'cui_str': 'Lidocaine Ophthalmic Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.496621,The addition of topical NSAID to proparacaine drops and lidocaine ophthalmic gel had negligible effect on subjective pain.,"[{'ForeName': 'Maxwell J', 'Initials': 'MJ', 'LastName': 'Wingelaar', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin-Madison, Madison, Wisconsin. Electronic address: mwingelaar@uwhealth.org.'}, {'ForeName': 'C Rufus', 'Initials': 'CR', 'LastName': 'Sweeney', 'Affiliation': 'School of Medicine and Public Health, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Thomas-Virnig', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Raevis', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Chang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Mihai', 'Initials': 'M', 'LastName': 'Mititelu', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin-Madison, Madison, Wisconsin.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.08.015']
2585,32858393,Reducing fall risk for home care workers with slip resistant winter footwear.,"Falls on icy surfaces are the leading cause of occupational injuries for workers exposed to outdoor winter conditions. Slip resistant footwear has been shown to reduce the risk of falls for indoor workers but until recently, there was no accepted standard for evaluating the slip resistance of winter footwear on icy surfaces. Our team recently developed a lab-based testing protocol for measuring footwear slip resistance. This protocol, called the Maximum Achievable Angle (MAA) test, measures the steepest ice-covered slope that participants can walk up and down without experiencing a slip in a simulated winter environment. This lab-based protocol has found there is wide variability in the performance of commercially available winter footwear. In particular, we have found that a new generation of footwear that incorporates composite materials in the outsole, performs much better than most other footwear. The objective of this project was to investigate whether the footwear that performed well in our lab-based testing would reduce the risk of slips and/or falls in real-world winter conditions. One hundred and ten home healthcare workers from SE Health were recruited for this study and were asked to report their exposure to icy surfaces along with the numbers of slips and numbers of falls they experienced each week using online surveys over eight weeks in the winter. Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test. The remaining sixty participants (the control group) wore their own footwear for the duration of the study. A total of 563 slips and 36 falls were reported over the eight-week data collection period. The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group. We found the slip rate in the intervention group was between 68.0% and 68.7% lower than the control group. Similarly, the fall rate was between 78.5% and 81.5% lower in the intervention group compared to the control group. These findings demonstrate that footwear that performs well in the MAA test can reduce the risk of both slips and falls in real-world winter conditions.",2021,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"['Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test', 'One hundred and ten home healthcare workers from SE Health', 'home care workers with slip resistant winter footwear']",[],"['fall rate', 'slip rate']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]",[],"[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}]",563.0,0.0200659,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"[{'ForeName': 'Z Shaghayegh', 'Initials': 'ZS', 'LastName': 'Bagheri', 'Affiliation': 'Department of Mechanical Engineering, George Mason University, 4400 University Dr, Fairfax, VA, 22030, USA; Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada. Electronic address: sbagheri@gmu.edu.'}, {'ForeName': 'Jose Diaz', 'Initials': 'JD', 'LastName': 'Beltran', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Holyoke', 'Affiliation': 'Saint Elizabeth Health Care, 90 Allstate Parkway, Suite 300, Markham, Ontario, L3R 5H3, Canada.'}, {'ForeName': 'Tilak', 'Initials': 'T', 'LastName': 'Dutta', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada; Institute of Biomedical Engineering, University of Toronto, 164 College St., Toronto, M5S3G9, Canada.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103230']
2586,32859109,Effects of Progressive Resistance Training on Cognition and IGF-1 Levels in Elder Women Who Live in Areas with High Air Pollution.,"The aim of this study was to determine the effects of a muscular strength programme on the levels of insulin-like growth factor-1 (IGF-1) and cognitive status in elder women with mild cognitive impairment who lived in areas of high air pollution. A total of 157 women participated in the study, distributed in four groups: Active/Clean (AC n = 38) and Active/Pollution (AP n = 37), who carried out a progressive resistance training programme for 24 months, and Sedentary/Clean (SC n = 40) and Sedentary/Pollution (SP n = 42). Maximum strength in the upper and lower limbs (1RM), cognition (Mini-Mental Scale Examination (MMSE)) and blood IGF-1 were evaluated. At the beginning of the intervention, there were no differences between the groups in the assessed variables. The active groups which carried out the resistance training programme (AC and AP), registered better results in IGF-1 than the sedentary groups. These differences were statistically significant in AC vs. SC ( p < 0.01) and AP vs. SC ( p < 0.05). Regarding MMSE, group AC registered the highest score increases (+8.2%) (significantly better than the other groups), while group SP worsened (-7%) significantly compared to the other three groups. In conclusion, resistance training had a positive effect on IGF-1, while sedentary behaviour and air pollution had a negative effect on cognitive status.",2020,"The active groups which carried out the resistance training programme (AC and AP), registered better results in IGF-1 than the sedentary groups.","['elder women with mild cognitive impairment who lived in areas of high air pollution', 'Who Live in Areas with High Air Pollution', '157 women participated in the study, distributed in four groups', 'Elder Women']","['Progressive Resistance Training', 'Active/Clean (AC n = 38) and Active/Pollution (AP n = 37), who carried out a progressive resistance training programme for 24 months, and Sedentary/Clean (SC n = 40) and Sedentary/Pollution', 'muscular strength programme']","['cognitive status', 'levels of insulin-like growth factor-1 (IGF-1) and cognitive status', 'Maximum strength in the upper and lower limbs (1RM), cognition (Mini-Mental Scale Examination (MMSE)) and blood IGF-1', 'IGF-1, while sedentary behaviour and air pollution', 'Cognition and IGF-1 Levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0392355', 'cui_str': 'Pollution'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0853230', 'cui_str': 'Blood insulin'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}]",157.0,0.0370053,"The active groups which carried out the resistance training programme (AC and AP), registered better results in IGF-1 than the sedentary groups.","[{'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Molina-Sotomayor', 'Affiliation': 'Facultad de Artes y Educación Física, Departamento de Educación Física, Universidad Metropolitana de Ciencias de la Educación, Santiago 8320000, Chile.'}, {'ForeName': 'Humberto', 'Initials': 'H', 'LastName': 'Castillo-Quezada', 'Affiliation': 'Facultad de Educación y Ciencias Sociales, Carrera de Educación Física, Universidad Andrés Bello, Concepción 4600000, Chile.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Martínez-Salazar', 'Affiliation': 'Facultad de Educación Ciencias Sociales y Humanidades, Departamento de Educación Física, Universidad de La Frontera, Temuco 4780000, Chile.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'González-Orb', 'Affiliation': 'Facultad de Artes y Educación Física, Departamento de Educación Física, Universidad Metropolitana de Ciencias de la Educación, Santiago 8320000, Chile.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Espinoza-Salinas', 'Affiliation': 'Escuela de Kinesiología, Universidad Santo Tomás, Santiago 8320000, Chile.'}, {'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'Gonzalez-Jurado', 'Affiliation': 'Physical Performance and Sports Research Centre, University of Pablo de Olavide, 41013 Sevilla, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17176203']
2587,32859607,Real-time CGM Is Superior to Flash Glucose Monitoring for Glucose Control in Type 1 Diabetes: The CORRIDA Randomized Controlled Trial.,"OBJECTIVE
The aim of this trial was to compare the efficacy of real-time and intermittently scanned continuous glucose monitoring (rtCGM and isCGM, respectively) in maintaining optimal glycemic control.
RESEARCH DESIGN AND METHODS
In this randomized study, adults with type 1 diabetes (T1D) and normal hypoglycemia awareness (Gold score <4) used rtCGM (Guardian Connect Mobile) or isCGM (FreeStyle Libre) during 4 days of physical activity (exercise phase) and in the subsequent 4 weeks at home (home phase). Primary end points were time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) and time in range (3.9-10.0 mmol/L [70-180 mg/dL]). The isCGM group wore an additional masked Enlite sensor (iPro2) for 6 days to check for bias between the different sensors used by the rtCGM and isCGM systems.
RESULTS
Sixty adults with T1D (mean age 38 ± 13 years; A1C 62 ± 12 mmol/mol [7.8 ± 1.1%]) were randomized to rtCGM ( n = 30) or isCGM ( n = 30). All participants completed the study. Percentage of time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) was lower among rtCGM versus isCGM participants in the exercise phase (6.8 ± 5.5% vs. 11.4 ± 8.6%, respectively; P = 0.018) and during the home phase (5.3 ± 2.5% vs. 7.3 ± 4.4%, respectively; P = 0.035). Hypoglycemia differences were significant and most notable during the night. rtCGM participants spent more time in range (3.9-10 mmol/L [70-180 mg/dL]) than isCGM participants throughout both the exercise (78.5 ± 10.2% vs. 69.7 ± 16%, respectively; P = 0.0149) and home (75.6 ± 9.7% vs. 67.4 ± 17.8%, respectively; P = 0.0339) phases. The results were robust to the insignificant bias between rtCGM and isCGM sensors that masked CGM found in the isCGM arm.
CONCLUSIONS
rtCGM was superior to isCGM in reducing hypoglycemia and improving time in range in adults with T1D with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.",2020,"CONCLUSIONS
rtCGM was superior to isCGM in reducing hypoglycemia and improving time in range in adults with T1D with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.","['adults with T1D with normal hypoglycemia awareness', 'adults with type 1 diabetes (T1D) and normal hypoglycemia awareness (Gold score <4) used rtCGM (Guardian Connect Mobile) or isCGM (FreeStyle Libre) during 4 days of physical activity (exercise phase) and in the subsequent 4 weeks at home (home phase', 'Sixty adults with T1D (mean age 38 ± 13 years; A1C 62 ± 12 mmol/mol [7.8 ± 1.1', 'Type 1 Diabetes']","['isCGM', 'rtCGM', 'real-time and intermittently scanned continuous glucose monitoring (rtCGM and isCGM', 'isCGM group wore an additional masked Enlite sensor (iPro2', 'Flash Glucose Monitoring']","['Hypoglycemia differences', 'time in hypoglycemia', 'Percentage of time in hypoglycemia', 'hypoglycemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",60.0,0.0495856,"CONCLUSIONS
rtCGM was superior to isCGM in reducing hypoglycemia and improving time in range in adults with T1D with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.","[{'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Hásková', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Radovnická', 'Affiliation': 'Masaryk Hospital, Ústí nad Labem, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Petruželková', 'Affiliation': 'Department of Paediatrics, 2nd Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Parkin', 'Affiliation': 'CGParkin Communications, Inc., Henderson, NV.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Grunberger', 'Affiliation': 'Grunberger Diabetes Institute, Bloomfield Hills, MI.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Horová', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Vendula', 'Initials': 'V', 'LastName': 'Navrátilová', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Ondřej', 'Initials': 'O', 'LastName': 'Kádě', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Matoulek', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Prázný', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Šoupal', 'Affiliation': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic jan.soupal@seznam.cz.'}]",Diabetes care,['10.2337/dc20-0112']
2588,32860791,Effects of Diet-Modulated Autologous Fecal Microbiota Transplantation on Weight Regain.,"BACKGROUND & AIMS
We evaluated the efficacy and safety of diet-modulated autologous fecal microbiota transplantation (aFMT) for treatment of weight regain after the weight loss phase.
METHODS
In the DIRECT-PLUS weight loss trial (May 2017 through July 2018), abdominally obese or dyslipidemic participants in Israel were randomly assigned to (1)healthy dietary guidelines, (2)Mediterranean diet, and (3)green-Mediterranean diet weight-loss groups. All groups received free gym membership and physical activity guidelines. Both iso-caloric Mediterranean groups consumed 28g/day walnuts (+440mg/d polyphenols provided). The green-Mediterranean dieters further consumed green tea (3-4 cups/day) and a Wolffia-globosa (Mankai strain;100g/day) green shake (+800mg/day polyphenols provided). After 6 months (weight-loss phase), 90 eligible participants (mean age, 52 years; mean weight loss, 8.3 kg) provided a fecal sample that was processed into aFMT by frozen, opaque and odorless capsules. The participants were then randomly assigned to groups that received 100 capsules containing their own fecal microbiota or placebo until month 14. The primary outcome was regain of the lost weight over the expected weight regain phase (months 6-14). Secondary outcomes were gastrointestinal symptoms, waist-circumference, glycemic status and changes in the gut microbiome, as measured by metagenomic sequencing and 16s-rRNA. We validated the results in a parallel in-vivo study of mice specifically fed with Mankai, as compared to control chow diet.
RESULTS
Of the 90 participants in the aFMT trial, 96% ingested at least 80 of 100 oral aFMT or placebo frozen capsules over the transplantation period. No aFMT-related adverse events or symptoms were observed. For the primary outcome, although no significant differences in weight regain were observed among the participants in the different lifestyle interventions during months 6-14 (aFMT, 30.4% vs. placebo, 40.6%;P=.28), aFMT significantly attenuated weight regain in the green-Mediterranean group (aFMT, 17.1%, vs placebo, 50%; P=.02), but not in the dietary guidelines (P=.57) or Mediterranean diet (P=.64) groups (P for the interaction=.03). Accordingly, aFMT attenuated waist circumference gain (aFMT, 1.89cm vs placebo, 5.05cm;P=.01) and insulin rebound (aFMT, 1.46±3.6μIU/ml vs placebo, 1.64±4.7μIU/ml;P=.04) in the green Mediterranean group but not in the dietary guidelines or Mediterranean diet (P for the interaction=.04 and .03, respectively). The green-Mediterranean diet was the only intervention to induce a significant change in microbiome composition during the weight loss phase, and to prompt preservation of weight loss-associated specific bacteria and microbial metabolic pathways (mainly microbial sugar transport) following the aFMT. In mice, Mankai-modulated aFMT in the weight loss phase, compared with control diet aFMT, significantly prevented weight regain, and resulted in better glucose tolerance, during a high-fat-diet induced regain phase (P<.05 for all).
CONCLUSIONS
Autologous FMT, collected during the weight loss phase and administrated in the regain phase, might preserve weight loss and glycemic control and is associated with specific microbiome signatures. High-polyphenols, green plant-based or Mankai diet better optimizes the microbiome for an aFMT procedure. (ClinicalTrials.gov number, NCT03020186).",2020,"For the primary outcome, although no significant differences in weight regain were observed among the participants in the different lifestyle interventions during months 6-14 (aFMT, 30.4% vs. placebo, 40.6%;P=.28), aFMT significantly attenuated weight regain in the green-Mediterranean group (aFMT, 17.1%, vs placebo, 50%; P=.02), but not in the dietary guidelines (P=.57) or Mediterranean diet (P=.64) groups (P for the interaction=.03).","['90 eligible participants (mean age, 52 years; mean weight loss, 8.3 kg) provided a fecal sample that was processed into aFMT by frozen, opaque and odorless capsules', 'Of the 90 participants in the aFMT trial, 96% ingested at least 80 of 100 oral', 'abdominally obese or dyslipidemic participants in Israel']","['aFMT or placebo', 'diet-modulated autologous fecal microbiota transplantation (aFMT', '100 capsules containing their own fecal microbiota or placebo', 'aFMT', 'Diet-Modulated Autologous Fecal Microbiota Transplantation', '1)healthy dietary guidelines, (2)Mediterranean diet, and (3)green-Mediterranean diet weight-loss groups', 'Mankai-modulated aFMT', 'High-polyphenols, green plant-based or Mankai diet']","['Weight Regain', 'aFMT attenuated waist circumference gain', 'regain of the lost weight over the expected weight regain phase', 'better glucose tolerance', 'weight regain', 'gastrointestinal symptoms, waist-circumference, glycemic status and changes in the gut microbiome, as measured by metagenomic sequencing and 16s-rRNA']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0029053', 'cui_str': 'Decreased translucency'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0022271', 'cui_str': 'Israel'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C3658297', 'cui_str': 'Dietary Guidelines'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}]",90.0,0.0688763,"For the primary outcome, although no significant differences in weight regain were observed among the participants in the different lifestyle interventions during months 6-14 (aFMT, 30.4% vs. placebo, 40.6%;P=.28), aFMT significantly attenuated weight regain in the green-Mediterranean group (aFMT, 17.1%, vs placebo, 50%; P=.02), but not in the dietary guidelines (P=.57) or Mediterranean diet (P=.64) groups (P for the interaction=.03).","[{'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Rinott', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Youngster', 'Affiliation': ""Pediatric Division and Center for Microbiome Research, Shamir Medical Center, Be'er Ya'akov, Israel; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: youngsteri@shamir.gov.il.""}, {'ForeName': 'Anat Yaskolka', 'Initials': 'AY', 'LastName': 'Meir', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Tsaban', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Zelicha', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Kaplan', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Knights', 'Affiliation': 'BioTechnology Institute, University of Minnesota; Saint Paul, MN 55108, USA; Department of Computer Science and Engineering, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Tuohy', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Via E. Mach 1, San Michele all'Adige, Trento 38016. Italy.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fava', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Via E. Mach 1, San Michele all'Adige, Trento 38016. Italy.""}, {'ForeName': 'Matthias Uwe', 'Initials': 'MU', 'LastName': 'Scholz', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Via E. Mach 1, San Michele all'Adige, Trento 38016. Italy.""}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Ziv', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Safed, Israel.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Reuven', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Safed, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Tirosh', 'Affiliation': ""Division of Endocrinology, Diabetes and Metabolism, Sheba Medical Center, Tel-Hashomer, Israel; and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel; Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Assaf', 'Initials': 'A', 'LastName': 'Rudich', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Blüher', 'Affiliation': 'Department of Medicine, University of Leipzig, German.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stumvoll', 'Affiliation': 'Department of Medicine, University of Leipzig, German.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Ceglarek', 'Affiliation': 'Department of Medicine, University of Leipzig, German.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Clement', 'Affiliation': 'Sorbonne University/Inserm, NutriOmics research Unit, Nutrition department, Pitié-Salpêtrière hospital, Assistance-publique Hopitaux de Paris, 75013, Paris, France.'}, {'ForeName': 'Omry', 'Initials': 'O', 'LastName': 'Koren', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Safed, Israel.'}, {'ForeName': 'Dong D', 'Initials': 'DD', 'LastName': 'Wang', 'Affiliation': 'Harvard T.H. Chan School of Public Health.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': ""Harvard T.H. Chan School of Public Health; Channing Division of Network Medicine, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Meir J', 'Initials': 'MJ', 'LastName': 'Stampfer', 'Affiliation': ""Harvard T.H. Chan School of Public Health; Channing Division of Network Medicine, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Adjunct Faculty, Harvard T.H. Chan School of Public Health.'}]",Gastroenterology,['10.1053/j.gastro.2020.08.041']
2589,32861516,The Effect of the Powerball Gyroscope as a Treatment Device for Nonspecific Wrist Pain.,"OBJECTIVE
The aim of this study was to determine the effect of using the Powerball gyroscope as a treatment device on pain and change in endurance in nonspecific wrist pain.
METHODS
This study was a within-participants pre- and postintervention study consisting of 40 participants between ages 18 and 35 with an equal male-to-female ratio. The participants used the Powerball gyroscope for 5 minutes per treatment session. Treatment comprised 12 sessions carried out 3 × per week over a 4-week period. Participants completed objective and subjective data before the first, seventh, and 12th sessions. Objective data were recorded using the Jamar dynamometer to measure grip strength. Subjective data were gathered using the Patient-Rated Wrist Evaluation Questionnaire. Participants then used the Powerball gyroscope in the hand with the affected wrist. The Wilcoxon signed rank test and 1-way repeated-measures analysis of variance were used to analyze the changes.
RESULTS
A significant decrease in pain was noted throughout the study, but the most significant changes occurred between the seventh and 12th treatment sessions (P < .01). A significant increase in grip strength was also noted throughout the study, with the greater increase in grip strength occurring during the first 7 treatments (P < .02).
CONCLUSION
The Powerball gyroscope showed a change in outcome regarding nonspecific wrist pain and grip strength.",2020,"A significant increase in grip strength was also noted throughout the study, with the greater increase in grip strength occurring during the first 7 treatments (P < .02).
","['Nonspecific Wrist Pain', '40 participants between ages 18 and 35 with an equal male-to-female ratio']","['Powerball Gyroscope', 'Powerball gyroscope']","['grip strength', 'nonspecific wrist pain and grip strength', 'pain']","[{'cui': 'C0221785', 'cui_str': 'Pain in wrist'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",[],"[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0221785', 'cui_str': 'Pain in wrist'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",40.0,0.0384773,"A significant increase in grip strength was also noted throughout the study, with the greater increase in grip strength occurring during the first 7 treatments (P < .02).
","[{'ForeName': 'Dirkie M', 'Initials': 'DM', 'LastName': 'Landman', 'Affiliation': 'Department of Chiropractic, Faculty of Health Sciences, University of Johannesburg, Johannesburg, South Africa. Electronic address: dirkiel@uj.ac.za.'}, {'ForeName': 'Jacques H', 'Initials': 'JH', 'LastName': 'Maree', 'Affiliation': 'Department of Chiropractic, Faculty of Health Sciences, University of Johannesburg, Johannesburg, South Africa.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Peterson', 'Affiliation': 'Department of Chiropractic, Faculty of Health Sciences, University of Johannesburg, Johannesburg, South Africa.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.11.002']
2590,32862662,Initial Invasive Versus Conservative Management of Stable Ischemic Heart Disease in Patients With a History of Heart Failure or Left Ventricular Dysfunction: Insights From the ISCHEMIA Trial.,"BACKGROUND
Whether an initial invasive strategy in patients with stable ischemic heart disease and at least moderate ischemia improves outcomes in the setting of a history of heart failure (HF) or left ventricular dysfunction (LVD) when ejection fraction is ≥35% but <45% is unknown.
METHODS
Among 5179 participants randomized into ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches), all of whom had left ventricular ejection fraction (LVEF) ≥35%, we compared cardiovascular outcomes by treatment strategy in participants with a history of HF/LVD at baseline versus those without HF/LVD. Median follow-up was 3.2 years.
RESULTS
There were 398 (7.7%) participants with HF/LVD at baseline, of whom 177 had HF/LVEF >45%, 28 HF/LVEF 35% to 45%, and 193 LVEF 35% to 45% but no history of HF. HF/LVD was associated with more comorbidities at baseline, particularly previous myocardial infarction, stroke, and hypertension. Compared with patients without HF/LVD, participants with HF/LVD were more likely to experience a primary outcome composite of cardiovascular death, nonfatal myocardial infarction, or hospitalization for unstable angina, HF, or resuscitated cardiac arrest (4-year cumulative incidence rate, 22.7% versus 13.8%; cardiovascular death or myocardial infarction, 19.7% versus 12.3%; and all-cause death or HF, 15.0% versus 6.9%). Participants with HF/LVD randomized to the invasive versus conservative strategy had a lower rate of the primary outcome (17.2% versus 29.3%; difference in 4-year event rate, -12.1% [95% CI, -22.6 to -1.6%]), whereas those without HF/LVD did not (13.0% versus 14.6%; difference in 4-year event rate, -1.6% [95% CI, -3.8% to 0.7%]; P interaction = 0.055). A similar differential effect was seen for the primary outcome, all-cause mortality, and cardiovascular mortality when invasive versus conservative strategy-associated outcomes were analyzed with LVEF as a continuous variable for patients with and without previous HF.
CONCLUSIONS
ISCHEMIA participants with stable ischemic heart disease and at least moderate ischemia with a history of HF or LVD were at increased risk for the primary outcome. In the small, high-risk subgroup with HF and LVEF 35% to 45%, an initial invasive approach was associated with better event-free survival. This result should be considered hypothesis-generating. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.",2020,"HF/LVD was associated with more comorbidities at baseline, particularly prior myocardial infarction (MI), stroke and hypertension.","['5179 participants', 'Stable Ischemic Heart Disease Patients with a History of Heart Failure or Left Ventricular Dysfunction', 'participants with stable ischemic heart disease and at least moderate ischemia with a history of HF or LVD', 'patients with stable ischemic heart disease', 'patients with a history of heart failure (HF) or left ventricular dysfunction (LVD']",['Initial Invasive versus Conservative Management'],"['better event-free survival', 'cardiovascular death or MI', 'cause mortality, and CV mortality', 'cardiovascular death, nonfatal MI, or hospitalization for unstable angina, HF, or resuscitated cardiac arrest; four-year cumulative incidence rate', 'myocardial infarction (MI), stroke and hypertension']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0242698', 'cui_str': 'Impaired left ventricular function'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",5179.0,0.202193,"HF/LVD was associated with more comorbidities at baseline, particularly prior myocardial infarction (MI), stroke and hypertension.","[{'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke University Medical Center, Durham, NC (R.D.L., M.K.).'}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (K.P.A., S.R.S., F.W.R.).'}, {'ForeName': 'Susanna R', 'Initials': 'SR', 'LastName': 'Stevens', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (K.P.A., S.R.S., F.W.R.).'}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': 'NYU Grossman School of Medicine, New York (H.R.R., J.S.H.).'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Cardiovascular Research Foundation, New York (G.W.S.).'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Wayne State University/Central Michigan University, Detroit (I.L.P.).'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (K.P.A., S.R.S., F.W.R.).'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elghamaz', 'Affiliation': 'Northwick Park Hospital-Royal Brompton Hospital, London, UK (A.E.).'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Lopez-Sendon', 'Affiliation': 'Hospital Universitario La Paz, IdiPaz, CIBER-CV, Madrid, Spain (J.L.L.-S.).'}, {'ForeName': 'Pedro S', 'Initials': 'PS', 'LastName': 'Farsky', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil (P.S.F.).'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Chernyavskiy', 'Affiliation': 'E. Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation, Moscow, Russia (A.M.C.).'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Diaz', 'Affiliation': 'CIUSSS-MCQ, University of Montreal, Campus Mauricie, Trois-Rivieres, Canada (A.D.).'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Phaneuf', 'Affiliation': 'Hôpital Pierre-Le Gardeur, Quebec, Canada (D.P.).'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'De Belder', 'Affiliation': 'Barts Health NHS Trust, London, UK (M.A.D.).'}, {'ForeName': 'Yi-Tong', 'Initials': 'YT', 'LastName': 'Ma', 'Affiliation': 'First Affiliated Hospital of Xinjiang Medical University, Urumqi, China (Y.-t.M.).'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Guzman', 'Affiliation': 'DAMIC Medical Institute, Cordoba, Argentina (L.A.G.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Khouri', 'Affiliation': 'Duke University Medical Center, Durham, NC (R.D.L., M.K.).'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sionis', 'Affiliation': 'Intensive Cardiac Care Unit, Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIB-Sant Pau, CIBER-CV, Universitat Autònoma de Barcelona, Spain (A.S.).'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Hausenloy', 'Affiliation': 'The Hatter Cardiovascular Institute, Institute of Cardiovascular Sciences, University College London, UK (D.J.H.).'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Doerr', 'Affiliation': 'Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.).'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Selvanayagam', 'Affiliation': 'Flinders Medical Centre, Adelaide, Australia (J.B.S.).'}, {'ForeName': 'Aldo Pietro', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Florence, Italy (A.P.M.).'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': 'NYU Grossman School of Medicine, New York (H.R.R., J.S.H.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, CA (D.J.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.120.050304']
2591,32798568,Effect of exercise and grape juice on epigenetic modulation and functional outcomes in PD: A randomized clinical trial.,"OBJECTIVE
This study aimed to investigate the impact of an aquatic physical training program associated with grape juice (Vitis labrusca) consumption on functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels in peripheral blood from individuals with Parkinson's disease.
METHODS
Nineteen participants were randomized to Aquatic Exercise (AQ, n = 9) and Aquatic Exercise + Grape Juice (AQ+GJ, n = 10) groups and performed to 4 weeks of an aquatic intervention (twice a week, approximately 60 min/session). The AQ+GJ groups also consumed 400 mL of grape juice per day during this period. Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS) were evaluated before and after intervention. In addition, blood collections were carried out for biomarker analysis (e.g. BDNF and global histone H4).
RESULTS
The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity. In addition, enhanced levels of BDNF and histone H4 acetylation were found after the intervention. Grape juice consumption did not potentiate these effects, since any significant differences between the AQ and AQ+GJ groups were not found in all analysed variables.
CONCLUSIONS
The present study provides important insights about aquatic exercise-modulated BDNF levels in individuals with Parkinson's disease in combination with functional improvements, suggesting that histone acetylation status may interact to dictate the molecular mechanisms involved in this response. Parkinson disease, aquatic exercise, BDNF, epigenetic, grape juice.",2020,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","['PD', ""individuals with Parkinson's disease"", ""peripheral blood from individuals with Parkinson's disease"", 'Nineteen participants']","['exercise and grape juice', 'AQ+GJ', 'aquatic exercise program', 'aquatic exercise-modulated BDNF levels', 'Aquatic Exercise (AQ, n=9) and Aquatic Exercise\u202f+\u202fGrape Juice (AQ+GJ, n=10) groups and performed to 4 weeks of an aquatic intervention', 'aquatic physical training program associated with grape juice (Vitis labrusca) consumption']","['functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels', 'enhanced levels of BDNF and histone H4 acetylation', 'Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS', 'epigenetic modulation and functional outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452455', 'cui_str': 'Grape juice'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0949819', 'cui_str': 'Vitis'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0019648', 'cui_str': 'Histone H4'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",19.0,0.0396303,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","[{'ForeName': 'Grazielle Silva De', 'Initials': 'GS', 'LastName': 'Oliveira', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Iraci', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Gislaine Siqueira', 'Initials': 'GS', 'LastName': 'Pinheiro', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Marcela Zimmermann', 'Initials': 'MZ', 'LastName': 'Casal', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Aline Nogueira', 'Initials': 'AN', 'LastName': 'Haas', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil.'}, {'ForeName': 'Flavia Gomes', 'Initials': 'FG', 'LastName': 'Martinez', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Elsner', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil; Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil; Programa de Pós-Graduação em Ciências Biológicas: Fisiologia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil. Electronic address: carolinedani@yahoo.com.br.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113135']
2592,32798570,Perceptual responses: Clinical versus practical blood flow restriction resistance exercise.,"The purpose of the current investigation was to compare the acute perceptual responses during low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE), to determine if these responses differed between young males and females. Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2 and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design: 1) cBFR-RE, 2) pBFR-RE, 3) HL-RE, and 4) LL-RE. Low-load conditions consisted of 30-15-15-15 repetitions of two-leg press (LP) and knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE consisted of 3 sets of 10 repetitions at 80% 1-RM, all with 60s rest intervals. Ratings of perceived exertion (RPE) and discomfort were assessed before exercise and immediately following each set. RPE was significantly higher in HL-RE compared to all low-load conditions for both exercises after each set (all p<0.05). cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05). Levels of discomfort were similar between cBFR-RE and HL-RE, which tended to be significantly higher than pBFR-RE and LL-RE (p<0.05). Men reported significantly greater RPE than women following sets 2-4 during KE with cBFR-RE and sets 2 and 3 during KE for HL-RE (all p<0.05). Males also reported significantly greater discomfort than women following sets 2-4 for KE LL-RE (p<0.05). Altogether, these data suggest that pBFR-RE may provide a more favorable BFR condition based on perceptual responses and that perceptual responses may differ between sexes across varying resistance exercise conditions.",2020,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"['Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2 and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design', 'young males and females']","['low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE', 'knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE']","['Levels of discomfort', 'Ratings of perceived exertion (RPE) and discomfort', 'acute perceptual responses', 'discomfort', 'RPE']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",,0.0352726,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA. Electronic address: ryanmiller1@ou.edu.'}, {'ForeName': 'Bianca A R', 'Initials': 'BAR', 'LastName': 'Galletti', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Karolina J', 'Initials': 'KJ', 'LastName': 'Koziol', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Eduardo D S', 'Initials': 'EDS', 'LastName': 'Freitas', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Heishman', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA; Department of Athletics, Basketball Strength and Performance, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Black', 'Affiliation': 'Department of Health and Exercise Science, Sensory and Muscle Function Research Laboratory, University of Oklahoma, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Larson', 'Affiliation': 'Departmeny of Health and Exercise Science, Sport, Health, and Exercise Data Analytics Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Bemben', 'Affiliation': 'Departmeny of Health and Exercise Science, Bone Density Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Bemben', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113137']
2593,32807435,Effect of Informational Support on Anxiety in Family Caregivers of Patients with Hemiplegic Stroke.,"BACKGROUND
Brain stroke causes physical and mental disabilities, as well as dependence on one's family. In such cases, the families suffer from severe crisis and anxiety due to the unexpected incidence of the disease and unawareness of the associated consequences.
OBJECTIVES
The aim of the present study was to evaluate the effectiveness of informational support on the level of anxiety in family caregivers of hemiplegic stroke patients.
METHODS
This quasi-experimental study was performed on 78 family caregivers of hemiplegic stroke patients admitted to the Neurology Department of Farshchian Hospital in Hamadan, Iran, over 8 months. The subjects were selected through convenience sampling method and divided into two groups of intervention (n = 40) and control (n = 38). Intervention started from the third day of hospitalization and continued until the eleventh day. During this period, information about the ward, equipment, patient status, and care procedure at home, was provided for the intervention group individually and in groups. On the other hand, the control group only received the routine care. Anxiety level of caregivers was measured through the Spielberger scale both before and after the intervention. Data analysis was performed in SPSS software (version 16).
RESULTS
Based on the results, both groups were similar in terms of demographic variables (P > 0.05). Moreover, there was no significant difference between the two groups regarding the mean level of state and trait anxiety before the intervention (P > 0.05). However, after intervention, the mean level of state and trait anxiety of the intervention group showed a significant reduction in comparison to that of the control group (P < 0.05).
CONCLUSIONS
According to the findings, it can be concluded that informational support is effective in reducing the state and trait anxiety in family caregivers of stroke patients. Therefore, it is suggested that nurses consider informational support as an important nursing intervention during hospitalization.",2020,"Moreover, there was no significant difference between the two groups regarding the mean level of state and trait anxiety before the intervention (P > 0.05).","['family caregivers of hemiplegic stroke patients', 'family caregivers of stroke patients', '78 family caregivers of hemiplegic stroke patients admitted to the Neurology Department of Farshchian Hospital in Hamadan, Iran, over 8 months', 'Family Caregivers of Patients with Hemiplegic Stroke']","['Informational Support', 'informational support']","['Anxiety level of caregivers', 'state and trait anxiety', 'mean level of state and trait anxiety']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587475', 'cui_str': 'Neurology department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",78.0,0.0165505,"Moreover, there was no significant difference between the two groups regarding the mean level of state and trait anxiety before the intervention (P > 0.05).","[{'ForeName': 'Azim', 'Initials': 'A', 'LastName': 'Azizi', 'Affiliation': 'PhD, Assistant Professor, Chronic Diseases (Home Care) Research Centre, Malayer Nursing School, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Khatiban', 'Affiliation': 'PhD, Professor, Mother & Child Care Research Center. Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Zhale', 'Initials': 'Z', 'LastName': 'Mollai', 'Affiliation': 'M.Sc in Critical Care Nursing, Student Research Committee, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: zhanet2811@gmail.com.'}, {'ForeName': 'Younes', 'Initials': 'Y', 'LastName': 'Mohammadi', 'Affiliation': 'PhD, Associate Professor, Department of Epidemiology, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105020']
2594,32807447,Pedaling improves gait ability of hemiparetic patients with stiff-knee gait: fall prevention during gait.,"BACKGROUND AND PURPOSE
Stiff-knee gait, which is a gait abnormality observed after stroke, is characterized by decreased knee flexion angles during the swing phase, and it contributes to a decline in gait ability. This study aimed to identify the immediate effects of pedaling exercises on stiff-knee gait from a kinesiophysiological perspective.
METHODS
Twenty-one patients with chronic post-stroke hemiparesis and stiff-knee gait were randomly assigned to a pedaling group and a walking group. An ergometer was set at a load of 5 Nm and rotation speed of 40 rpm, and gait was performed at a comfortable speed; both the groups performed the intervention for 10 min. Kinematic and electromyographical data while walking on flat surfaces were immediately measured before and after the intervention.
RESULTS
In the pedaling group, activity of the rectus femoris significantly decreased from the pre-swing phase to the early swing phase during gait after the intervention. Flexion angles and flexion angular velocities of the knee and hip joints significantly increased during the same period. The pedaling group showed increased step length on the paralyzed side and gait velocity.
CONCLUSIONS
Pedaling increases knee flexion during the swing phase in hemiparetic patients with stiff-knee gait and improves gait ability.",2020,"In the pedaling group, activity of the rectus femoris significantly decreased from the pre-swing phase to the early swing phase during gait after the intervention.","['Twenty-one patients with chronic post-stroke hemiparesis and stiff-knee gait', 'hemiparetic patients with stiff-knee gait']","['pedaling group and a walking group', 'pedaling exercises']","['gait ability', 'activity of the rectus femoris', 'paralyzed side and gait velocity', 'Flexion angles and flexion angular velocities of the knee and hip joints', 'knee flexion', 'step length', 'Kinematic and electromyographical data while walking on flat surfaces', 'knee flexion angles']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0427141', 'cui_str': 'Stiff knee gait'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0522224', 'cui_str': 'Paralysis'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",21.0,0.0178517,"In the pedaling group, activity of the rectus femoris significantly decreased from the pre-swing phase to the early swing phase during gait after the intervention.","[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Science, Fukui Health Science University, 55-13-1 Egami, Fukui-city 910-3190, Fukui, Japan. Electronic address: k.fujita@fukui-hsu.ac.jp.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Science, Fukui Health Science University, 55-13-1 Egami, Fukui-city 910-3190, Fukui, Japan. Electronic address: yasutaka_k@fukui-hsu.ac.jp.'}, {'ForeName': 'Hiroichi', 'Initials': 'H', 'LastName': 'Miaki', 'Affiliation': 'Faculty of Health Sciences, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa-city, Ishikawa, Japan. Electronic address: miaki@mhs.mp.kanazawa-u.ac.jp.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Hori', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Science, Fukui Health Science University, 55-13-1 Egami, Fukui-city 910-3190, Fukui, Japan. Electronic address: rpt-hori@fukui-hsu.ac.jp.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Tsushima', 'Affiliation': 'Department of Physical Therapy Rehabilitation, Fukui General Hospital, Fukui-city, Fukui, Japan. Electronic address: yuuichi1685@yahoo.co.jp.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Sakai', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Science, Fukui Health Science University, 55-13-1 Egami, Fukui-city 910-3190, Fukui, Japan. Electronic address: r-sakai@fukui-hsu.ac.jp.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Nomura', 'Affiliation': 'Department of Physical Therapy Rehabilitation, Fukui General Hospital, Fukui-city, Fukui, Japan. Electronic address: tomomi3222@yahoo.co.jp.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Department of Physical Therapy Rehabilitation, Fukui General Hospital, Fukui-city, Fukui, Japan. Electronic address: hal.ntsl.pal@hotmail.co.jp.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Physical Therapy Rehabilitation, Fukui General Hospital, Fukui-city, Fukui, Japan. Electronic address: hiro-kino@kj.ttn.ne.jp.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Nishida', 'Affiliation': 'Department of Physical Therapy Rehabilitation, Fukui General Hospital, Fukui-city, Fukui, Japan. Electronic address: fsmsc@f-gh.jp.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Hitosugi', 'Affiliation': 'Department of Legal Medicine, Shiga University of Medical Science, Otsu-city, Shiga, Japan. Electronic address: hitosugi@belle.shiga-med.ac.jp.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105035']
2595,32813290,Working memory training restores aberrant brain activity in adult attention-deficit hyperactivity disorder.,"The development of treatments for attention impairments is hampered by limited knowledge about the malleability of underlying neural functions. We conducted the first randomized controlled trial to determine the modulations of brain activity associated with working memory (WM) training in adults with attention-deficit hyperactivity disorder (ADHD). At baseline, we assessed the aberrant functional brain activity in the n-back WM task by comparing 44 adults with ADHD with 18 healthy controls using fMRI. Participants with ADHD were then randomized to train on an adaptive dual n-back task or an active control task. We tested whether WM training elicits redistribution of brain activity as observed in healthy controls, and whether it might further restore aberrant activity related to ADHD. As expected, activity in areas of the default-mode (DMN), salience (SN), sensory-motor (SMN), frontoparietal (FPN), and subcortical (SCN) networks was decreased in participants with ADHD at pretest as compared with healthy controls, especially when the cognitive load was high. WM training modulated widespread FPN and SN areas, restoring some of the aberrant activity. Training effects were mainly observed as decreased brain activity during the trained task and increased activity during the untrained task, suggesting different neural mechanisms for trained and transfer tasks.",2020,"Training effects were mainly observed as decreased brain activity during the trained task and increased activity during the untrained task, suggesting different neural mechanisms for trained and transfer tasks.","['44 adults with ADHD with 18 healthy controls using fMRI', 'Participants with ADHD', 'adults with attention-deficit hyperactivity disorder (ADHD', 'adult attention-deficit hyperactivity disorder', 'healthy controls']","['working memory (WM) training', 'WM training', 'Working memory training', 'adaptive dual n-back task or an active control task']","['activity in areas of the default-mode (DMN), salience (SN), sensory-motor (SMN), frontoparietal (FPN), and subcortical (SCN) networks', 'aberrant functional brain activity', 'brain activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0865424', 'cui_str': 'Adult attention deficit hyperactivity disorder'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",44.0,0.0412269,"Training effects were mainly observed as decreased brain activity during the trained task and increased activity during the untrained task, suggesting different neural mechanisms for trained and transfer tasks.","[{'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Salmi', 'Affiliation': 'Department of Neuroscience and Biomedical Engineering, Aalto University, Espoo, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Soveri', 'Affiliation': 'Department of Clinical Medicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Viljami', 'Initials': 'V', 'LastName': 'Salmela', 'Affiliation': 'Department of Psychology and Logopedics, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Alho', 'Affiliation': 'Department of Psychology and Logopedics, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Leppämäki', 'Affiliation': 'Department of Psychiatry, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Tani', 'Affiliation': 'Department of Psychiatry, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Anniina', 'Initials': 'A', 'LastName': 'Koski', 'Affiliation': 'Department of Psychiatry, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Jaeggi', 'Affiliation': 'School of Education, University of California Irvine, Irvine, California, USA.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Department of Psychology, Åbo Akademi University, Turku, Finland.'}]",Human brain mapping,['10.1002/hbm.25164']
2596,32814123,Application of continuous passive motion in patients with distal radius fractures: A randomized clinical trial.,"The aim of this study was to know if applying continuous passive motion (CPM) in addition to routine exercises is more effective than routine exercises alone in pain reduction, range of motion (ROM) and function improvement after distal radius fractures (DRFs). In this randomized controlled trial, 21 patients with non-stabilized DRF after pin removal were randomly assigned to experimental and control groups. The experimental group received stretching exercises with CPM machine for 2×15min per session. Both groups received routine exercises for 1h, three times a week for 4 weeks. The primary outcome measure was pain evaluated on a visual analog scale (VAS), and the secondary outcome measures were disability evaluated by the patient-rated wrist/hand evaluation and ROM (goniometry) at 4, 6, and 12 weeks. Univariate analysis of covariance (ANCOVA) and a one-way repeated measure mixed model analysis of variance (ANOVA) were used for data analysis. Twenty-one participants completed the 12-week follow-up. Pain relief, ROM and functional improvement revealed that the treatment was successful in both groups. We detected no significant differences (p>0.05) between the two groups at the end of the follow-up period regarding pain, ROM, and function. Using a CPM machine had no additional effect on pain reduction, ROM and function improvement compared with routine exercises in patients with DRF.",2020,"Using a CPM machine had no additional effect on pain reduction, ROM and function improvement compared with routine exercises in patients with DRF.","['patients with DRF', '21 patients with non-stabilized DRF after pin removal', 'patients with distal radius fractures']","['routine exercises', 'CPM machine', 'continuous passive motion', 'stretching exercises with CPM machine', 'continuous passive motion (CPM']","['pain, ROM, and function', 'Pain relief, ROM and functional improvement', 'pain evaluated on a visual analog scale (VAS', 'pain reduction, range of motion (ROM) and function improvement after distal radius fractures (DRFs', 'pain reduction, ROM and function improvement', 'disability evaluated by the patient-rated wrist/hand evaluation and ROM (goniometry']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",21.0,0.0547275,"Using a CPM machine had no additional effect on pain reduction, ROM and function improvement compared with routine exercises in patients with DRF.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shirzadi', 'Affiliation': 'Occupational Therapy, University of Social Welfare and Rehabilitation Sciences, Daneshjoo Blvd, Tehran, Iran. Electronic address: ashirzadi71@gmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Farzad', 'Affiliation': 'Occupational Therapy, University of Social Welfare and Rehabilitation Sciences, Daneshjoo Blvd, Tehran, Iran; Physical therapy, University of Western Ontario, London, Ontario, Canada. Electronic address: mfarzad@uwo.ca.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Farhoud', 'Affiliation': 'Orthopedic Surgery, Imam Hospital Complex, Tehran University of Medical Sciences, Joint Reconstruction Research Center, Iran. Electronic address: am_farhoud@yahoo.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Shafiee', 'Affiliation': 'Physical therapy, University of Western Ontario, London, Ontario, Canada. Electronic address: eshafiee@uwo.ca.'}]",Hand surgery & rehabilitation,['10.1016/j.hansur.2020.08.001']
2597,32819413,Impact of a ketogenic diet intervention during radiotherapy on body composition: III-final results of the KETOCOMP study for breast cancer patients.,"BACKGROUND
Obesity and low muscle mass are associated with worse outcomes of breast cancer patients. We conducted a controlled trial to study the impact of a ketogenic diet (KD) based on natural foods versus an unspecified standard diet (SD) on body composition in breast cancer patients undergoing radiotherapy.
METHODS
Patients with non-metastasized breast cancer were allocated to either the KD (N = 32) or the SD (N = 31) during radiotherapy. Body composition was measured weekly by bioimpedance analysis. Blood parameters and quality of life were assessed before, during, and at the end of radiotherapy.
RESULTS
A total of 29 KD and 30 SD patients completed the study. During radiotherapy, mean and median fasting BHB concentrations in the KD group were 0.72 and 0.49 mmol/l (range 0.06-4.9) which was significantly higher than those in the SD group (p < 2.2 × 10 -16 ). There was a very small and insignificant increase in body weight and fat mass in the SD group, as well as a decrease of fat free mass. In contrast, patients in the KD group lost body weight and fat free and skeletal muscle mass quickly after diet onset, which for the most part was related to water losses. The KD did not cause further substantial changes in fat free or skeletal muscle mass, but was associated with a gradual decrease of 0.4 kg body weight and fat mass per week (p < 0.0001). The KD significantly decreased free T3 levels by 0.06 pg/ml/week (p = 6.3 × 10 -5 ). Global quality of life remained stable in the SD group but increased in the KD group from a score of 66.7 to 75.0 (p = 0.20).
CONCLUSIONS
In breast cancer patients undergoing curative radiotherapy, a KD based on natural foods is feasible. After initial water losses, the KD tends to reduce body weight and fat mass while preserving fat free and skeletal muscle mass.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT02516501 , registered on August 06, 2015.",2020,The KD significantly decreased free T3 levels by 0.06 pg/ml/week (p = 6.3 × 10 -5 ).,"['breast cancer patients undergoing', 'Patients with non-metastasized breast cancer', 'breast cancer patients', 'breast cancer patients undergoing radiotherapy', 'A total of 29 KD and 30 SD patients completed the study']","['ketogenic diet intervention', 'ketogenic diet (KD) based on natural foods versus an unspecified standard diet (SD', 'radiotherapy', 'curative radiotherapy']","['fat free or skeletal muscle mass', 'Body composition', 'body composition', 'Blood parameters and quality of life', 'free T3 levels', 'body weight and fat free and skeletal muscle mass', 'mean and median fasting BHB concentrations', 'Global quality of life', 'body weight and fat mass']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0519160', 'cui_str': 'Triiodothyronine, free measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0482809,The KD significantly decreased free T3 levels by 0.06 pg/ml/week (p = 6.3 × 10 -5 ).,"[{'ForeName': 'Rainer J', 'Initials': 'RJ', 'LastName': 'Klement', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany. rainer_klement@gmx.de.'}, {'ForeName': 'Colin E', 'Initials': 'CE', 'LastName': 'Champ', 'Affiliation': 'Department of Radiation Oncology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Kämmerer', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Petra S', 'Initials': 'PS', 'LastName': 'Koebrunner', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany.'}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Krage', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Schäfer', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weigel', 'Affiliation': 'Department of Obstetrics and Gynaecology, Leopoldina Hospital, Breast Cancer Centre, Schweinfurt, Germany.'}, {'ForeName': 'Reinhart A', 'Initials': 'RA', 'LastName': 'Sweeney', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany.'}]",Breast cancer research : BCR,['10.1186/s13058-020-01331-5']
2598,32820647,"Recruitment, retention, and adherence in a clinical trial: The Pediatric Heart Network's Marfan Trial experience.","BACKGROUND/AIMS
The Pediatric Heart Network Marfan Trial was a randomized trial comparing atenolol versus losartan on aortic root dilation in 608 children and young adults with Marfan syndrome. Barriers to enrollment included a limited pool of eligible participants, restrictive entry criteria, and a diverse age range that required pediatric and adult expertise. Retention was complicated by a 3-year commitment to a complex study and medication regimen. The Network partnered with the Marfan Foundation, bridging the community with the research. The aims of this study are to report protocol and medication adherence and associated predictive factors, and to describe recruitment and retention strategies.
METHODS
Recruitment, retention, and adherence to protocol activities related to the primary outcome were measured. Retention was measured by percentage of enrolled participants with 3-year outcome data. Protocol adherence was calculated by completion rates of study visits, ambulatory electrocardiography (Holter monitoring), and quarterly calls. Medication adherence was assessed by the number of tablets or the amount of liquid in bottles returned. Centers were ranked according to adherence (high, medium, and low tertiles). Recruitment, retention, and adherence questionnaires were completed by sites. Descriptive statistics summarized recruitment, retention, and adherence, as well as questionnaire results. Regression modeling assessed predictors of adherence.
RESULTS
Completion rates for visits, Holter monitors, and quarterly calls were 99%, 94%, and 96%, respectively. Primary outcome data at 3 years were obtained for 88% of participants. The mean percentage of medication taken was estimated at 89%. Site and age were associated with all measures of adherence. Young adult and African American participants had lower levels of adherence. Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation's resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence.
CONCLUSION
Overall adherence was excellent for this trial conducted within a National Institutes of Health-funded clinical trial network. Strategies specifically targeted to young adults and African Americans may have been beneficial. Many strategies employed by higher adherence sites are ones that any site could easily use, such as greeting families at non-study hospital visits, asking for family feedback, providing calendars for tracking schedules, and recommending apps for medication reminders. Additional key learnings include adherence differences by age, race, and site, the value of collaborative learning, and the importance of partnerships with patient advocacy groups. These lessons could shape recruitment, retention, and adherence to improve the quality of future complex trials involving rare conditions.",2020,"Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation's resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence.
","['young adults and African Americans', 'Young adult and African American participants', 'eligible participants, restrictive entry criteria, and a diverse age range that required pediatric and adult expertise', '608 children and young adults with Marfan syndrome']","['losartan', 'atenolol']","['Medication adherence', 'Recruitment, retention, and adherence questionnaires', 'Retention', 'mean percentage of medication taken', 'Completion rates for visits, Holter monitors, and quarterly calls', 'completion rates of study visits, ambulatory electrocardiography (Holter monitoring), and quarterly calls', 'Recruitment, retention, and adherence', 'Protocol adherence', 'Overall adherence', 'lower levels of adherence']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013801', 'cui_str': 'Electrocardiography, Holter'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013799', 'cui_str': 'Ambulatory ECG'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",608.0,0.169075,"Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation's resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence.
","[{'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Hamstra', 'Affiliation': ""Heart Institute Administration, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Pemberton', 'Affiliation': 'National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Dagincourt', 'Affiliation': 'New England Research Institutes, Inc., Watertown, MA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hollenbeck-Pringle', 'Affiliation': 'New England Research Institutes, Inc., Watertown, MA, USA.'}, {'ForeName': 'Felicia L', 'Initials': 'FL', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes, Inc., Watertown, MA, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Cnota', 'Affiliation': ""Heart Institute Administration, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Atz', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cappella', 'Affiliation': ""Ann and Robert H. Lurie Children's Hospital, Chicago, IL, USA.""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'De Nobele', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Grima', 'Affiliation': 'The Marfan Foundation, Port Washington, NY, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'King', 'Affiliation': ""Harvard Medical School, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Korsin', 'Affiliation': ""Children's Hospital of New York, New York, NY, USA.""}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Lambert', 'Affiliation': ""Primary Children's Hospital, University of Utah, Salt Lake City, UT, USA.""}, {'ForeName': 'Meghan K', 'Initials': 'MK', 'LastName': 'MacNeal', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Markham', 'Affiliation': ""The Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, TN, USA.""}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'MacCarrick', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Sylvester', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Walter', 'Affiliation': 'Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Mingfen', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Ronald V', 'Initials': 'RV', 'LastName': 'Lacro', 'Affiliation': ""Harvard Medical School, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774520945988']
2599,32825378,Effects of Six Weeks of High-Intensity Functional Training on Physical Performance in Participants with Different Training Volumes and Frequencies.,"High-intensity functional training (HIFT) is characterized by presenting high volumes and training intensities with constantly varied exercises. The aim of this study was to analyze the internal training load and the effects of high-intensity functional training on physical performance in subjects with different training volumes and frequencies. A total of 31 volunteers involved in high-intensity functional training (14 men and 17 women) were divided according to their training volumes and frequencies (high training-volume and frequency-HTVF; ( n = 17) (nine women and eight men; age: 31.0 ± 6.3 years; height: 168.8 ± 8.1 cm, body weight: 73.6 ± 11.9 kg; BMI: 25.96 kg/m 2 ) and moderate training volume and frequency-MTVF; ( n = 14) (eight women and six men; age: 26.6 ± 4.7 years; height: 167.2 ± 8.6 cm, body weight: 75.8 ± 18.0 kg; BMI: 27.33 kg/m 2 )). The internal training load was determined using the session-rating of perceived exertion method. The monotony index (MI) and training strain (TS) were used to determine training variability during the training weeks. Countermovement vertical jump height, 20-m sprinting and handgrip strength were assessed at baseline and after six weeks of training. There was a time effect for MI ((F (5, 145) = 5.942; p = 0.0001)), TS ((F (5, 145) = 5.734; p = 0.0001)), weekly internal training load ((F (4.006, 116.87) = 4.188; p = 0.003)) and mean weekly internal training load ((F (4.006, 116.87) = 4.188; p = 0.003)). There was no increase in performance in either group for countermovement vertical jump height ((F (1,29) = 6.081; p = 0.050)), sprinting ((F (1,29) = 1.014; p = 0.322)), right handgrip strength ((F (1,29) = 2.522; p = 0.123)) or left handgrip strength ((F (1,29) = 2.550; p = 0.121)). The current findings suggest that six weeks of high-intensity functional training was not able to increase performance in either group. Therefore, different volumes and frequencies do not seem to influence the increase in physical performance of HIFT practitioners.",2020,"There was no increase in performance in either group for countermovement vertical jump height ((F (1,29) = 6.081; p = 0.050)), sprinting ((F (1,29) = 1.014; p = 0.322)), right handgrip strength ((F (1,29) = 2.522; p = 0.123)) or left handgrip strength ((F (1,29) = 2.550; p = 0.121)).","['Participants with Different Training Volumes and Frequencies', ' n = 17) (nine women and eight men; age: 31.0 ± 6.3 years; height: 168.8 ± 8.1 cm, body weight: 73.6 ± 11.9 kg; BMI: 25.96 kg/m 2 ) and moderate training volume and frequency-MTVF; ( n = 14) (eight women and six men; age: 26.6 ± 4.7 years; height: 167.2 ± 8.6 cm, body weight: 75.8 ± 18.0 kg; BMI: 27.33 kg/m 2 ', 'subjects with different training volumes and frequencies', '31 volunteers involved in high-intensity functional training (14 men and 17 women']","['training volumes and frequencies (high training-volume and frequency-HTVF', 'High-Intensity Functional Training', 'high-intensity functional training', 'High-intensity functional training (HIFT']","['weekly internal training load', 'performance', 'countermovement vertical jump height', 'right handgrip strength', 'monotony index (MI) and training strain (TS', 'mean weekly internal training load', 'Countermovement vertical jump height, 20-m sprinting and handgrip strength', 'physical performance', 'left handgrip strength', 'Physical Performance']","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205091', 'cui_str': 'Left'}]",31.0,0.0237396,"There was no increase in performance in either group for countermovement vertical jump height ((F (1,29) = 6.081; p = 0.050)), sprinting ((F (1,29) = 1.014; p = 0.322)), right handgrip strength ((F (1,29) = 2.522; p = 0.123)) or left handgrip strength ((F (1,29) = 2.550; p = 0.121)).","[{'ForeName': 'Rômulo Vasconcelos', 'Initials': 'RV', 'LastName': 'Teixeira', 'Affiliation': 'Graduate Program on Physical Education, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte 59072970, Brazil.'}, {'ForeName': 'Gilmário Ricarte', 'Initials': 'GR', 'LastName': 'Batista', 'Affiliation': 'Department of Physical Education, Federal University of Paraíba, João Pessoa, Paraíba 58051900, Brazil.'}, {'ForeName': 'Arnaldo Luis', 'Initials': 'AL', 'LastName': 'Mortatti', 'Affiliation': 'Graduate Program on Physical Education, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte 59072970, Brazil.'}, {'ForeName': 'Paulo Moreira Silva', 'Initials': 'PMS', 'LastName': 'Dantas', 'Affiliation': 'Graduate Program on Physical Education, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte 59072970, Brazil.'}, {'ForeName': 'Breno Guilherme de Araújo Tinôco', 'Initials': 'BGAT', 'LastName': 'Cabral', 'Affiliation': 'Graduate Program on Physical Education, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte 59072970, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17176058']
2600,32825509,Continuous Compared to Accumulated Walking-Training on Physical Function and Health-Related Quality of Life in Sedentary Older Persons.,"The present study aimed to analyze the impact of overground walking interval training (WIT) in a group of sedentary older adults, comparing two different dose-distributions. In this quasi-experimental and longitudinal study, we recruited twenty-three sedentary older adults (71.00 ± 4.10 years) who were assigned to two groups of WIT. The continuous group (CWIT) trained for 60 min/session in the morning, while the accumulated group (AWIT) performed the same duration and intensity of exercise, but it was distributed twice a day (30 min in the morning and 30 more in the afternoon). After 15 weeks of an equal external-load training (3 days/week), Bonferroni post-hoc comparisons revealed significant ( p < 0.050) and similar large improvements in both groups in cardiorespiratory fitness and lower limb strength; even larger gains in preferred walking speed and instrumental daily life activity, which was slightly superior for CWIT; and improvements in agility, which were moderate for CWIT and large for AWIT. However, none of the training protocols had an impact on the executive function in the individuals, and only the AWIT group improved health-related quality of life. Although both training protocols induced a general significant improvement in physical function in older adults, our results showed that the accumulative strategy should be recommended when health-related quality of life is the main target, and the continuous strategy should be recommended when weakness may be a threat in the short or medium term.",2020,"However, none of the training protocols had an impact on the executive function in the individuals, and only the AWIT group improved health-related quality of life.","['twenty-three sedentary older adults (71.00 ± 4.10 years) who were assigned to two groups of WIT', 'older adults', 'Sedentary Older Persons', 'a group of sedentary older adults']","['Accumulated Walking-Training', 'overground walking interval training (WIT']","['Physical Function and Health-Related Quality of Life', 'physical function', 'walking speed and instrumental daily life activity', 'health-related quality of life', 'executive function', 'cardiorespiratory fitness and lower limb strength']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",23.0,0.0179847,"However, none of the training protocols had an impact on the executive function in the individuals, and only the AWIT group improved health-related quality of life.","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Monteagudo', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Ainoa', 'Initials': 'A', 'LastName': 'Roldán', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Cordellat', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Mari Carmen', 'Initials': 'MC', 'LastName': 'Gómez-Cabrera', 'Affiliation': 'Freshage Research Group, Department of Physiology, faculty of Medicine, University of Valencia, CIBERFES, Fundación Investigación Hospital Clínico Universitario/INCLIVA, 46010 Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17176060']
2601,32825535,Physical Activity Counseling for Adults with Hypertension: A Randomized Controlled Pilot Trial.,"The effect of physical activity counseling (PAC) in hypertensive adults is unclear. This study investigated the effect of PAC on blood pressure (BP), physical activity level, sitting time, metabolic profile, and body composition in hypertensive adults. Twenty-two hypertensive adults (48.8 ± 7.3 years) participated in this pilot trial. The 12-week PAC was based on the 5 A's model considering the FITT principle (Frequency, Intensity, Time, and Type) of physical activity. The control group received instructions about FITT in one face-to-face meeting at baseline. Pedometer-measured physical activity, sitting time, resting and ambulatory BP, metabolic profile (cholesterol, triglycerides, fasting glucose), and body composition (fat mass, abdominal fat, fat free mass) were assessed. The PAC group showed higher steps per day (5839 ± 992 vs. 5028 ± 902; p = 0.044) and a trend for lower sitting time (5.6 ± 1.3 vs. 8.0 ± 4.0 h/day; p = 0.059) than the control group. No changes were observed in BP, metabolic profile, and body composition ( p > 0.05). In conclusion, 12 weeks of a PAC program based on the 5 A's model resulted in a modest increase of ~800 steps per day and a trend to decrease ~2 h/day in sitting time, but there were no associated reduction in BP and improvements in metabolic and body composition.",2020,The PAC group showed higher steps per day (5839 ± 992 vs. 5028 ± 902; p = 0.044) and a trend for lower sitting time (5.6 ± 1.3 vs. 8.0 ± 4.0 h/day; p = 0.059) than the control group.,"['Adults with Hypertension', 'Twenty-two hypertensive adults (48.8 ± 7.3 years', 'hypertensive adults']","['physical activity counseling (PAC', 'Physical Activity Counseling', 'PAC', 'instructions about FITT']","['Pedometer-measured physical activity, sitting time, resting and ambulatory BP, metabolic profile (cholesterol, triglycerides, fasting glucose), and body composition (fat mass, abdominal fat, fat free mass', 'BP and improvements in metabolic and body composition', 'lower sitting time', 'blood pressure (BP), physical activity level, sitting time, metabolic profile, and body composition', 'BP, metabolic profile, and body composition']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0060398', 'cui_str': 'FITT'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",22.0,0.0226444,The PAC group showed higher steps per day (5839 ± 992 vs. 5028 ± 902; p = 0.044) and a trend for lower sitting time (5.6 ± 1.3 vs. 8.0 ± 4.0 h/day; p = 0.059) than the control group.,"[{'ForeName': 'Altieres E', 'Initials': 'AE', 'LastName': 'Sousa Junior', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}, {'ForeName': 'Geovani A D', 'Initials': 'GAD', 'LastName': 'Macêdo', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schwade', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}, {'ForeName': 'Júlio', 'Initials': 'J', 'LastName': 'Sócrates', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Rio Grande do Norte, Natal 59012-570, RN, Brazil.'}, {'ForeName': 'José W', 'Initials': 'JW', 'LastName': 'Alves', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}, {'ForeName': 'Luiz F', 'Initials': 'LF', 'LastName': 'Farias-Junior', 'Affiliation': 'Graduate Program in Psychobiology, Federal University of Rio Grande do Norte, Natal 59064-741, RN, Brazil.'}, {'ForeName': 'Yuri A', 'Initials': 'YA', 'LastName': 'Freire', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}, {'ForeName': 'Telma M A M', 'Initials': 'TMAM', 'LastName': 'Lemos', 'Affiliation': 'Department of Clinical and Toxicological Analysis, Federal University of Rio Grande do Norte, Natal 59012-570, RN, Brazil.'}, {'ForeName': 'Rodrigo A V', 'Initials': 'RAV', 'LastName': 'Browne', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Rio Grande do Norte, Natal 59012-570, RN, Brazil.'}, {'ForeName': 'Eduardo C', 'Initials': 'EC', 'LastName': 'Costa', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17176076']
2602,32825555,Beneficial Effects of Interactive Physical-Cognitive Game-Based Training on Fall Risk and Cognitive Performance of Older Adults.,"Physical and cognitive declines are significant risk factors for falls. Promising evidence suggests that combined physical-cognitive training would be an effective fall risk reduction and cognitive improvement intervention. However, a limited number of studies have been conducted and findings have been inconclusive. This study investigated the effects of interactive physical-cognitive game-based training on the fall risk and cognitive performance of older adults. Forty participants were randomly allocated to the intervention (n = 20) and control (n = 20) groups. Participants in the intervention group performed a 1 h session, 3 times a week for 12 weeks of the interactive physical-cognitive game-based training program. Fall risk (Physiological Profile Assessment, PPA; and Timed Up and Go, TUG) and cognitive outcome (Montreal Cognitive Assessment, MoCA) were assessed at pre- and post-intervention. Thirty-nine participants (mean age = 69.81 ± 3.78 years) completed the study (97.5%). At the end of the trial, participants in the intervention group demonstrated significant improvement in the PPA fall risk score ( p = 0.015), postural sway ( p = 0.005), MoCA score ( p = 0.001), and TUG-dual task ( p = 0.045) compared to controls. In conclusion, the interactive physical-cognitive, game-based training was effective in reducing physiological fall risk and improving cognitive function in community-dwelling older adults.",2020,"At the end of the trial, participants in the intervention group demonstrated significant improvement in the PPA fall risk score ( p = 0.015), postural sway ( p = 0.005), MoCA score ( p = 0.001), and TUG-dual task ( p = 0.045) compared to controls.","['Older Adults', 'older adults', 'community-dwelling older adults', 'Thirty-nine participants (mean age = 69.81 ± 3.78 years) completed the study (97.5', 'Forty participants']","['Interactive Physical-Cognitive Game-Based Training', 'interactive physical-cognitive game-based training program', 'interactive physical-cognitive game-based training', 'interactive physical-cognitive, game-based training', 'combined physical-cognitive training']","['Fall risk (Physiological Profile Assessment, PPA; and Timed Up and Go, TUG) and cognitive outcome (Montreal Cognitive Assessment, MoCA', 'MoCA score', 'TUG-dual task', 'PPA fall risk score', 'fall risk and cognitive performance', 'Fall Risk and Cognitive Performance', 'physiological fall risk and improving cognitive function', 'postural sway']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031495', 'cui_str': 'Phenylpropanolamine'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205278', 'cui_str': 'Postural'}]",40.0,0.0128531,"At the end of the trial, participants in the intervention group demonstrated significant improvement in the PPA fall risk score ( p = 0.015), postural sway ( p = 0.005), MoCA score ( p = 0.001), and TUG-dual task ( p = 0.045) compared to controls.","[{'ForeName': 'Kochaphan', 'Initials': 'K', 'LastName': 'Phirom', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Teerawat', 'Initials': 'T', 'LastName': 'Kamnardsiri', 'Affiliation': 'Department of Digital Game, College of Arts, Media, and Technology, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Somporn', 'Initials': 'S', 'LastName': 'Sungkarat', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai 50200, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph17176079']
2603,32822676,Survival Following Detection of Stage I Lung Cancer by Screening in the National Lung Screening Trial.,"BACKGROUND
There is limited information about survival of stage I lung cancer diagnosed by screening.
RESEARCH QUESTION
What was the survival rate of screen-detected stage I lung cancer in the National Lung Screening Trial (NLST), and was it affected by screening method, patient or tumor characteristics, or treatment method?
STUDY DESIGN AND METHODS
The study cohort consisted of all NLST participants with screen-detected stage I lung cancer. Lung cancer-specific survival for stage I overall and for IA and IB substages were compared in the low-dose CT and chest radiography (CXR) screening randomization arms and with an analogous cohort from the Surveillance, Epidemiology, and End Results Program of the National Cancer Institute; the cumulative incidence competing risk method was used for analysis. Cox proportional hazards models were used to evaluate the association between lung cancer-specific survival and screening arm, patient factors, primary tumor size, and treatment.
RESULTS
There were 324 screen-detected stage I lung cancers in the low-dose CT arm and 125 in the CXR arm. The 10-year survival in the low-dose CT arm was greater than in the CXR arm (73.4% vs 64.6%; P = .05), and both were greater than in the Surveillance, Epidemiology, and End Results cohort (55.6%; P < .001 vs low-dose CT arm, P = .04 vs CXR arm). Proportional hazards models revealed a greater likelihood of survival in the low-dose CT arm (hazard ratio [HR], 0.69; 95% CI, 0.5-0.98) and with primary tumor size below the median of 17 mm (HR, 0.61; 95% CI, 0.42-0.88). There was no survival difference between treatment with limited resection vs full resection (HR, 1.12; 95% CI, 0.65-1.9), whereas nonsurgical treatment was associated with a reduced likelihood of survival compared with full resection (HR, 3.0; 95% CI, 1.5-5.9).
INTERPRETATION
Long-term lung cancer-specific survival of stage I lung cancer was greater with low-dose CT imaging than with CXR screening or in the general population, for smaller primary tumor size, and with surgical treatment.",2020,"There was no survival difference between treatment with limited resection vs. full resection (HR 1.12, 95% CI 0.65-1.9), while nonsurgical treatment was associated with reduced likelihood of survival compared to full resection (HR 3.0, 95% CI 1.5-5.9).
","['participants with screen-detected Stage I lung cancer', 'I lung cancer diagnosed by screening']","['CT', 'NLST']","['survival difference', '324 screen-detected Stage I lung cancers', 'Survival', 'survival rate of screen-detected Stage I lung cancer', '10-year survival', 'likelihood of survival', 'Lung cancer-specific survival']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.198326,"There was no survival difference between treatment with limited resection vs. full resection (HR 1.12, 95% CI 0.65-1.9), while nonsurgical treatment was associated with reduced likelihood of survival compared to full resection (HR 3.0, 95% CI 1.5-5.9).
","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Gierada', 'Affiliation': 'Mallinckrodt Institute of Radiology, Washington University School of Medicine, Saint Louis, MO. Electronic address: gieradad@wustl.edu.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Pinsky', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, MD.'}]",Chest,['10.1016/j.chest.2020.08.2048']
2604,32827501,Intranasal vasopressin expedites dishonesty in women.,"As an integral ingredient of human sociality, dishonesty can be both egocentric and altruistic, as well as gradually escalate. Here, we examined the influence of arginine vasopressin (AVP), a neuropeptide associated with human prosocial behaviors, on dishonest behaviors in men and women. In this double-blind and placebo-controlled study, 101 participants were randomized to administration of either 20 IU intranasal AVP or placebo. We used a two-party task to manipulate the incentive structure of dishonesty in the way of self-/other-serving repeatedly. For lies that benefit both themselves and others, women receiving intranasal AVP lied more than women receiving intranasal placebo and men receiving intranasal AVP. The dishonest behavior of women treated with AVP gradually escalated with repetition over time. These results suggest that AVP selectively regulates the escalation of dishonesty in women, contingent on the motivation of dishonesty. Our findings provide insight into gender-specific modulations of AVP on human dishonest behavior.",2020,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","['females', '101 participants', 'males and females']","['Intranasal vasopressin', 'intranasal AVP', 'AVP', 'intranasal placebo', '20\u202fIU intranasal AVP or placebo', 'arginine vasopressin (AVP', 'placebo']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],101.0,0.145508,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","[{'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application, Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, China. Electronic address: chunliang.feng@m.scnu.edu.cn.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Yuejia', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Beijing Key Laboratory of Applied Experimental Psychology, Faculty of Psychology, Beijing Normal University, Beijing, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China; Great Bay Neuroscience and Technology Research Institute (Hong Kong), Kwun Tong, Hong Kong, China. Electronic address: xupf@szu.edu.cn.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104843']
2605,32866432,"Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial.","BACKGROUND
Bortezomib, lenalidomide, and dexamethasone (VRd) is a standard therapy for newly diagnosed multiple myeloma. Carfilzomib, a next-generation proteasome inhibitor, in combination with lenalidomide and dexamethasone (KRd), has shown promising efficacy in phase 2 trials and might improve outcomes compared with VRd. We aimed to assess whether the KRd regimen is superior to the VRd regimen in the treatment of newly diagnosed multiple myeloma in patients who were not being considered for immediate autologous stem-cell transplantation (ASCT).
METHODS
In this multicentre, open-label, phase 3, randomised controlled trial (the ENDURANCE trial; E1A11), we recruited patients aged 18 years or older with newly diagnosed multiple myeloma who were ineligible for, or did not intend to have, immediate ASCT. Participants were recruited from 272 community oncology practices or academic medical centres in the USA. Key inclusion criteria were the absence of high-risk multiple myeloma and an Eastern Cooperative Oncology Group performance status of 0-2. Enrolled patients were randomly assigned (1:1) centrally by use of permuted blocks to receive induction therapy with either the VRd regimen or the KRd regimen for 36 weeks. Patients who completed induction therapy were then randomly assigned (1:1) a second time to either indefinite maintenance or 2 years of maintenance with lenalidomide. Randomisation was stratified by intent for ASCT at disease progression for the first randomisation and by the induction therapy received for the second randomisation. Allocation was not masked to investigators or patients. For 12 cycles of 3 weeks, patients in the VRd group received 1·3 mg/m 2 of bortezomib subcutaneously or intravenously on days 1, 4, 8, and 11 of cycles 1-8, and day 1 and day 8 of cycles nine to twelve, 25 mg of oral lenalidomide on days 1-14, and 20 mg of oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, and 12. For nine cycles of 4 weeks, patients in the KRd group received 36 mg/m 2 of intravenous carfilzomib on days 1, 2, 8, 9, 15, and 16, 25 mg of oral lenalidomide on days 1-21, and 40 mg of oral dexamethasone on days 1, 8, 15, and 22. The coprimary endpoints were progression-free survival in the induction phase, and overall survival in the maintenance phase. The primary analysis was done in the intention-to-treat population and safety was assessed in patients who received at least one dose of their assigned treatment. The trial is registered with ClinicalTrials.gov, NCT01863550. Study recruitment is complete, and follow-up of the maintenance phase is ongoing.
FINDINGS
Between Dec 6, 2013, and Feb 6, 2019, 1087 patients were enrolled and randomly assigned to either the VRd regimen (n=542) or the KRd regimen (n=545). At a median follow-up of 9 months (IQR 5-23), at a second planned interim analysis, the median progression-free survival was 34·6 months (95% CI 28·8-37·8) in the KRd group and 34·4 months (30·1-not estimable) in the VRd group (hazard ratio [HR] 1·04, 95% CI 0·83-1·31; p=0·74). Median overall survival has not been reached in either group. The most common grade 3-4 treatment-related non-haematological adverse events included fatigue (34 [6%] of 527 patients in the VRd group vs 29 [6%] of 526 in the KRd group), hyperglycaemia (23 [4%] vs 34 [6%]), diarrhoea (23 [5%] vs 16 [3%]), peripheral neuropathy (44 [8%] vs four [<1%]), dyspnoea (nine [2%] vs 38 [7%]), and thromboembolic events (11 [2%] vs 26 [5%]). Treatment-related deaths occurred in two patients (<1%) in the VRd group (one cardiotoxicity and one secondary cancer) and 11 (2%) in the KRd group (four cardiotoxicity, two acute kidney failure, one liver toxicity, two respiratory failure, one thromboembolic event, and one sudden death).
INTERPRETATION
The KRd regimen did not improve progression-free survival compared with the VRd regimen in patients with newly diagnosed multiple myeloma, and had more toxicity. The VRd triplet regimen remains the standard of care for induction therapy for patients with standard-risk and intermediate-risk newly diagnosed multiple myeloma, and is a suitable treatment backbone for the development of combinations of four drugs.
FUNDING
US National Institutes of Health, National Cancer Institute, and Amgen.",2020,"The KRd regimen did not improve progression-free survival compared with the VRd regimen in patients with newly diagnosed multiple myeloma, and had more toxicity.","['Patients who completed induction therapy', '1087 patients', 'Participants were recruited from 272 community oncology practices or academic medical centres in the USA', 'patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE', 'patients with standard-risk and intermediate-risk newly diagnosed multiple myeloma', 'newly diagnosed multiple myeloma in patients who were not being considered for immediate autologous stem-cell transplantation (ASCT', 'newly diagnosed multiple myeloma', 'patients aged 18 years or older with newly diagnosed multiple myeloma who were ineligible for, or did not intend to have, immediate ASCT']","['lenalidomide and dexamethasone', 'KRd', 'lenalidomide and dexamethasone (KRd', 'bortezomib', 'oral dexamethasone', 'indefinite maintenance or 2 years of maintenance with lenalidomide', 'VRd regimen', 'KRd regimen', 'intravenous carfilzomib', 'Carfilzomib or bortezomib', 'induction therapy with either the VRd regimen or the KRd regimen', 'oral lenalidomide', 'Bortezomib, lenalidomide, and dexamethasone (VRd']","['thromboembolic events', 'cardiotoxicity, two acute kidney failure, one liver toxicity, two respiratory failure, one thromboembolic event, and one sudden death', 'diarrhoea', 'intention-to-treat population and safety', 'deaths', 'progression-free survival in the induction phase, and overall survival', 'progression-free survival', 'toxicity', 'dyspnoea', 'median progression-free survival', 'Median overall survival', 'peripheral neuropathy', 'hyperglycaemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0360528', 'cui_str': 'Dexamethasone-containing product in oral dose form'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",1087.0,0.211992,"The KRd regimen did not improve progression-free survival compared with the VRd regimen in patients with newly diagnosed multiple myeloma, and had more toxicity.","[{'ForeName': 'Shaji K', 'Initials': 'SK', 'LastName': 'Kumar', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA. Electronic address: kumar.shaji@mayo.edu.'}, {'ForeName': 'Susanna J', 'Initials': 'SJ', 'LastName': 'Jacobus', 'Affiliation': 'ECOG-ACRIN Biostatistics Center, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Cohen', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'ThedaCare, Appleton, WI, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Callander', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Avina K', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'MOHPA, Burnsville, MN, USA.'}, {'ForeName': 'Terri L', 'Initials': 'TL', 'LastName': 'Parker', 'Affiliation': 'Department of Hematology, Yale University, Hamden, CT, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Kaiser Permanente Lone Tree, Lone Tree, CO, USA.'}, {'ForeName': 'Xuezhong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Saint Francis Cancer Center, Greenville, NC, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Parsons', 'Affiliation': 'Gundersen Health System, La Crosse, WI, USA.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Illinois Cancer Care, Peoria, IL, USA.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Kapoor', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Rosenberg', 'Affiliation': 'University of California Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Zonder', 'Affiliation': 'Department of Malignant Hematology, Barbara Ann Karmanos Cancer Institute and Wayne State University School of Medicine, Detroit, MI, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Faber', 'Affiliation': 'Oncology Hematology Care, Cincinnati, OH, USA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Anderson', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Sciences, Winston-Salem, NC, USA.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30452-6']
2606,32870042,Autologous Protein Solution Injections for the Treatment of Knee Osteoarthritis: 3-Year Results.,"BACKGROUND
Blood derivative injections have been recently proposed to address osteoarthritis (OA) with overall positive results, although long-term data on their efficacy are lacking. A novel blood derivative has been developed to concentrate growth factors and antagonists of inflammatory cytokines and shown promising early findings.
PURPOSE
To investigate if the positive effects of a single intra-articular injection of autologous protein solution (APS) in patients affected by knee OA-previously documented at 1 year in a multicenter double-blind randomized saline-controlled trial-last up to 3 years.
STUDY DESIGN
Case series; Level of evidence, 4.
METHODS
A total of 46 patients with Kellgren-Lawrence 2 or 3 knee OA were randomized into 2 groups: 1 ultrasound-guided APS injection (n = 31) or 1 saline injection (n = 15). At 1 year, the saline group was allowed to cross over. Patients were re-evaluated at 24 and 36 months through the visual analog scale for pain (VAS), Western Ontario and McMaster Universities Osteoarthritis Index Likert 3.1 (WOMAC LK 3.1), Knee injury and Osteoarthritis Outcome Score (KOOS), 36-Item Short Form Health Survey (SF-36), and Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responder rate. Magnetic resonance imaging evaluation was performed with the MRI Osteoarthritis Knee Score (MOAKS) before and at 24 months after treatment, and radiographs were assessed per Kellgren-Lawrence before and annually after treatment.
RESULTS
In the APS cohort, WOMAC pain improved from 11.5 ± 2.4 (mean ± SD) to 4.3 ± 4.0 at 1 year and to 5.7 ± 5.0 at 3 years ( P < .0001 vs baseline). The APS cohort also showed a statistically significant improvement in its KOOS pain score from 39.4 ± 13.1 to 70.6 ± 21.5 at 1 year and to 64.1 ± 24.6 at 3 years ( P < .0001 vs baseline) and VAS pain scores from 5.5 ± 2.2 to 2.6 ± 2.5 at 1 year and to 3.4 ± 2.9 at 3 years ( P = .0184 vs baseline). VAS pain score significantly worsened from 12 to 36 months ( P = .0411). All patients in the saline group decided to cross over to APS, and their final scores were better than baseline, although not significantly better than at the crossover point. Overall, 7 of 26 (26.9%) APS cases and 4 of 14 (28.6%) crossover cases were considered failures as patients underwent further injective treatments or surgical procedures between the 12- and 36-month follow-up. MOAKS findings showed no statistically significant differences. Patients with better cartilage had greater WOMAC pain improvement when their baseline scores were worse, whereas the trend was reversed for patients with cartilage loss at baseline.
CONCLUSION
Intra-articular use of APS for mild to moderate knee OA was safe, and significant pain improvement was documented 3 years after a single injection. Patients with better cartilage status seem to respond better than patients with more cartilage loss, with more clinical improvement even when starting from more painful conditions.
REGISTRATION
NCT02138890 (ClinicalTrials.gov identifier).",2020,VAS pain score significantly worsened from 12 to 36 months ( P = .0411).,"['46 patients with Kellgren-Lawrence 2 or 3 knee OA', 'patients affected by knee OA-previously documented at 1 year', 'Knee Osteoarthritis']","['ultrasound-guided APS injection', 'Autologous Protein Solution Injections', 'saline injection', 'single intra-articular injection of autologous protein solution (APS']","['VAS pain score', 'visual analog scale for pain (VAS), Western Ontario and McMaster Universities Osteoarthritis Index Likert 3.1 (WOMAC LK 3.1), Knee injury and Osteoarthritis Outcome Score (KOOS), 36-Item Short Form Health Survey (SF-36), and Outcome Measures in Rheumatology-Osteoarthritis Research Society International', 'MRI Osteoarthritis Knee Score (MOAKS', 'KOOS pain score', 'WOMAC pain', 'WOMAC pain improvement', 'VAS pain scores', 'pain improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0991511', 'cui_str': 'Solution for injection'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",46.0,0.239781,VAS pain score significantly worsened from 12 to 36 months ( P = .0411).,"[{'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Kon', 'Affiliation': 'Humanitas University Department of Biomedical Sciences, Humanitas Clinical and Research Center, IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Engebretsen', 'Affiliation': 'Orthopaedic Clinic, University of Oslo, and Oslo Sports Trauma Research Center, Norwegian College of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verdonk', 'Affiliation': 'Department of Orthopaedic Surgery, Monica Hospitals-Monica Research Foundation, and Department of Orthopaedic Surgery, University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Nehrer', 'Affiliation': 'Dekan Fakultät Gesundheit und Medizin, Leiter Department für Gesundheitswissenschaften und Biomedizin, Leiter Zentrum für Regenerative Medizin und Orthopädie, Krems, Austria.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Filardo', 'Affiliation': 'Applied and Translational Research Center, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}]",The American journal of sports medicine,['10.1177/0363546520944891']
2607,32876780,Efficacy and safety results from a randomized double-blind study comparing proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate-to-severe rheumatoid arthritis.,"BACKGROUND/OBJECTIVES
ABP 798 is a proposed biosimilar to the originator biologic rituximab, an anti-CD20 monoclonal antibody. This comparative clinical study evaluated the pharmacokinetics (PK), safety, and efficacy of ABP 798 versus rituximab reference product (RP) in patients with moderate-to-severe rheumatoid arthritis (RA).
METHODS
Adults with moderate-to-severe RA with an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs including 1 or more tumor necrosis factor inhibitor therapies (n = 311) received ABP 798, US-sourced rituximab RP (rituximab US), or EU-sourced rituximab RP (rituximab EU) (1000 mg, 2 weeks apart). At week 24, ABP 798- or rituximab EU-treated subjects received a second dose of the same treatment, while rituximab US-treated subjects transitioned to receive ABP 798. The key efficacy endpoint was DAS28-CRP change from baseline at week 24. Other efficacy endpoints included DAS28-CRP at other time points; ACR20, ACR50, and ACR70 criteria; and hybrid ACR. The rituximab RP groups were pooled for all efficacy endpoints since PK equivalence had been established between rituximab US and rituximab EU.
RESULTS
Clinical equivalence between ABP 798 and rituximab RP was established as the 90% confidence interval for DAS28-CRP change from baseline at week 24 fell within the prespecified equivalence margin (- 0.6, 0.6). Safety and immunogenicity profiles of ABP 798 were comparable across treatment groups and not affected by single transition from RP to ABP 798.
CONCLUSIONS
Clinical equivalence in terms of efficacy, safety, and immunogenicity was established between ABP 798 and rituximab RP in this comparative clinical trial in patients with moderate-to-severe RA. Key Points • ABP 798 provided similar efficacy as rituximab reference product (RP) in patients with moderate-severe rheumatoid arthritis. • The safety and immunogenicity profiles for ABP 798 were similar to those for the rituximab RP. • The single transition from rituximab RP to ABP 798 did not show differences in efficacy, safety, or immunogenicity.",2020,"Safety and immunogenicity profiles of ABP 798 were comparable across treatment groups and not affected by single transition from RP to ABP 798.
","['patients with moderate-to-severe RA', 'patients with moderate-severe rheumatoid arthritis', 'Adults with moderate-to-severe RA with an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs including 1 or more tumor necrosis factor inhibitor therapies (n\u2009=\u2009311) received', 'subjects with moderate-to-severe rheumatoid arthritis', 'patients with moderate-to-severe rheumatoid arthritis (RA']","['ABP 798 versus rituximab reference product (RP', 'biosimilar ABP 798 with rituximab reference product', 'rituximab US-treated subjects transitioned to receive ABP 798', 'ABP 798, US-sourced rituximab RP (rituximab US), or EU-sourced rituximab RP (rituximab EU']","['efficacy, safety, and immunogenicity', 'DAS28-CRP at other time points; ACR20, ACR50, and ACR70 criteria; and hybrid ACR', 'pharmacokinetics (PK), safety, and efficacy', 'Safety and immunogenicity profiles', 'Efficacy and safety', 'efficacy, safety, or immunogenicity', 'safety and immunogenicity profiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0001239', 'cui_str': 'Actin-binding protein'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.0484735,"Safety and immunogenicity profiles of ABP 798 were comparable across treatment groups and not affected by single transition from RP to ABP 798.
","[{'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Burmester', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Free University and Humboldt University Berlin, Charité-University Medicine Berlin, Charitéplatz 1, 10117, Berlin, Germany. gerd.burmester@charite.de.'}, {'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Drescher', 'Affiliation': 'Veszprém Csolnoky Ferenc County Hospital, Veszprém, Hungary.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Hrycaj', 'Affiliation': 'Rheumatology, Koscian Municipal Hospital, Koscian, Poland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, Dallas, TX, USA.'}]",Clinical rheumatology,['10.1007/s10067-020-05305-y']
2608,32871454,Difficulties in developmental follow-up of preterm neonates in a randomised-controlled trial of Bifidobacterium breve M16-V - Experience from Western Australia.,"BACKGROUND
Probiotics may be neuroprotective for preterm neonates due to their anti-inflammatory effects and ability to facilitate nutrition.
AIM
To assess long-term effects of early probiotic supplementation on neuropsychological development in preterm infants.
STUDY DESIGN
Follow up study.
SUBJECTS
Children at age 3 to 5 years who had participated as preterm infants (<33 week) in the randomised controlled trial.
OUTCOMES
Primary: Continuous early learning composite measure derived from the Mullen's Scale of Early Learning (MSEL). Other outcomes were assessed by the Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition.
MEASURES
Continuous scores derived from all the measures.
RESULTS
67 children of the 159 participants (42%) (Probiotic: 36/79, Placebo: 31/80) were followed-up for at least one neuropsychological assessment. All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children. Multivariable analysis of MSEL composite score showed no evidence of probiotic effect univariately, or after adjustment for gestation, intrauterine growth restriction, Apgar <7 at 5 min and age at assessment (adjusted mean effect in probiotic group: -2.7, 95% CI -8.5-3.0, p = 0.349).
CONCLUSION
There was no significant effect on neurodevelopment of children assessed at the age of 3 to 5 years who participated as preterm neonates in the RCT of B. breve M-16V. The validity of these results is limited by the reduced sample size due to high rate of loss to follow up.",2020,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"['preterm infants', 'Children at age 3 to 5\xa0years who had participated as preterm infants (<33\xa0week', 'preterm neonates', '67 children of the 159 participants (42', 'from Western Australia']","['early probiotic supplementation', 'Placebo', 'Bifidobacterium breve M16-V - Experience', 'M-16V']","[""Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition"", ""Mullen's Scale of Early Learning (MSEL""]","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C3875061', 'cui_str': 'Developmental, dimensional and diagnostic interview'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",159.0,0.215666,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia. Electronic address: sachin.agrawal@health.wa.gov.au.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Pestell', 'Affiliation': 'School of Psychological Science, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Granich', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Neonatal Pediatrics, Perth Children Hospital, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nathan', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Women and Infants Research Foundation, King Edward Memorial Hospital for Women, 374, Bagot Road, Subiaco, Perth, WA, Australia.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Wray', 'Affiliation': 'Child Development Centre, 4/16 Rheola St, West Perth, WA 6005, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}, {'ForeName': 'A J O', 'Initials': 'AJO', 'LastName': 'Whitehouse', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Patole', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}]",Early human development,['10.1016/j.earlhumdev.2020.105165']
2609,32872348,"How Can We Improve the Consumption of a Nutritionally Balanced Maternal Diet in Rural Bangladesh? The Key Elements of the ""Balanced Plate"" Intervention.","Social, cultural, environmental and economic factors closely regulate the selection, allocation and consumption of maternal diets. We developed a nutrition behaviour change intervention to promote a balanced diet in pregnancy through practical demonstration in rural Bangladesh and tested the impact with a cluster randomised controlled trial. This paper presents the findings of the process evaluation and describes the strategies that worked for intervention compliance. We conducted in-depth interviews with pregnant women, women who birthed recently, and their husbands; focus groups with mothers and mothers-in-law; key-informant interviews with community health workers, and observations of home visits. We identified six key areas within the intervention strategy that played a crucial role in achieving the desired adherence. These included practical demonstration of portion sizes; addressing local food perceptions; demystifying animal-source foods; engaging husbands and mothers-in-law; leveraging women's social networks; and harnessing community health workers' social role. Practical demonstration, opportunity to participate and convenience of making of the plate with the food available in their kitchen or neighbours' kitchen were the most commonly mentioned reasons for acceptance of the intervention by the women and their families. The balanced plate intervention helped women through practical demonstration to learn about a balanced meal by highlighting appropriate portion sizes and food diversity. The women needed active involvement of community health workers in mobilising social support to create an enabling environment essential to bring changes in dietary behaviours. Future implementation of the intervention should tailor the strategies to the local context to ensure optimal adherence to the intervention.",2020,The women needed active involvement of community health workers in mobilising social support to create an enabling environment essential to bring changes in dietary behaviours.,"['pregnant women, women who birthed recently, and their husbands; focus groups with mothers and mothers-in-law; key-informant interviews with community health workers, and observations of home visits']",['nutrition behaviour change intervention to promote a balanced diet'],[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2349972', 'cui_str': 'Mother in-law'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0452410', 'cui_str': 'Balanced diet'}]",[],,0.023163,The women needed active involvement of community health workers in mobilising social support to create an enabling environment essential to bring changes in dietary behaviours.,"[{'ForeName': 'Ashraful', 'Initials': 'A', 'LastName': 'Alam', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney 2006, Australia.'}, {'ForeName': 'Morseda', 'Initials': 'M', 'LastName': 'Chowdhury', 'Affiliation': 'Health, Nutrition and Population Programme, Bangladesh Rural Advancement Committee (BRAC), Dhaka 1212, Bangladesh.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Dibley', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney 2006, Australia.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Raynes-Greenow', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney 2006, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17176289']
2610,32815436,Clinical review of the efficacy and safety of oral semaglutide in patients with type 2 diabetes compared with other oral antihyperglycemic agents and placebo.,"Oral semaglutide is a tablet formulation of a glucagon-like peptide-1 receptor agonist (GLP-1RA), recently approved in the USA and other countries. This paper reviews data from clinical trials (PIONEER 1, 2, 3, and 7) comparing oral semaglutide (once-daily doses of 3, 7, or 14 mg) with either once-daily placebo, empagliflozin 25 mg, or sitagliptin 100 mg. After 26 weeks in PIONEER 1, patients randomized to 3, 7, or 14 mg doses of oral semaglutide monotherapy had statistically significant reductions in glycated hemoglobin (HbA 1 c ) of 0.9%, 1.2%, and 1.4%, respectively, versus 0.3% with placebo. In the active-comparator studies, oral semaglutide 14 mg provided better glycemic control than empagliflozin or sitagliptin after 26 weeks, with durable effects. Body weight reductions were significantly greater with oral semaglutide than with placebo and sitagliptin. However, body weight reductions with oral semaglutide 14 mg versus empagliflozin 25 mg were not significantly different. Gastrointestinal adverse events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early in the course of treatment, and abated over time. Across these trials, 5-13% and 15-20% of patients experienced nausea with oral semaglutide 7 and 14 mg, respectively, and 2.3-3.4% and 5.1-8.0%, respectively, discontinued treatment due to gastrointestinal AEs. Severe or blood glucose-confirmed symptomatic hypoglycemia occurred infrequently with oral semaglutide and was seen most often in patients taking concomitant sulfonylureas. Findings from these trials indicate that the addition of oral semaglutide reduces HbA 1 c and body weight and is associated with a low risk of hypoglycemia. Oral semaglutide represents an additional option for treating people with type 2 diabetes in primary care, with the potential to expand the numbers of patients benefiting from GLP-1RAs beyond that currently seen with injectable formulations.",2020,"Gastrointestinal adverse events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early in the course of treatment, and abated over time.",['patients with type 2 diabetes'],"['Oral semaglutide', 'oral semaglutide monotherapy', 'empagliflozin', 'oral antihyperglycemic agents and placebo', 'placebo, empagliflozin 25 mg, or sitagliptin 100 mg', 'oral semaglutide', 'placebo']","['HbA 1c and body weight', 'Body weight reductions', 'glycated hemoglobin (HbA 1c ', 'Severe or blood glucose-confirmed symptomatic hypoglycemia', 'body weight reductions', 'nausea', 'Gastrointestinal adverse events (AEs) with oral semaglutide']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3848772', 'cui_str': 'empagliflozin 25 MG [Jardiance]'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}]",,0.127093,"Gastrointestinal adverse events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early in the course of treatment, and abated over time.","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lavernia', 'Affiliation': 'North Broward Diabetes Center , Pompano Beach, FL, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Blonde', 'Affiliation': 'Department of Endocrinology, Ochsner Medical Center , New Orleans, LA, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1798638']
2611,32815439,"Oral semaglutide in patients with type 2 diabetes and cardiovascular disease, renal impairment, or other comorbidities, and in older patients.","Patients with type 2 diabetes (T2D) often have comorbidities, such as cardiovascular disease or chronic kidney disease, and a large and growing proportion of the T2D patient population is over 65 years. There are many therapies for the treatment of T2D but not all are suitable for patients with comorbidities. Oral semaglutide is a tablet formulation of a glucagon-like peptide-1 receptor agonist (GLP-1RA) and was recently approved for the treatment of T2D, representing an oral alternative to injectable GLP-1RAs. This article reviews data from: PIONEER 6, a phase 3a cardiovascular outcomes trial in patients at high cardiovascular risk; PIONEER 5, a phase 3a trial in patients with moderate renal impairment; a post-hoc analysis of PIONEER data by age; and pharmacokinetic trials investigating the effects of renal impairment, gastrointestinal disease, and hepatic impairment on the exposure of oral semaglutide. PIONEER 6 demonstrated the cardiovascular safety of oral semaglutide compared with placebo (hazard ratio: 0.79; 95% confidence interval [CI]: 0.57, 1.11; p < 0.001 for noninferiority), ruling out excess cardiovascular risk. In PIONEER 5, oral semaglutide was superior to placebo in decreasing glycated hemoglobin over 26 weeks (estimated treatment difference [ETD]: -0.8%; 95% CI: -1.0, -0.6; p < 0.0001) and body weight (ETD: -2.5 kg; 95% CI: -3.2, -1.8; p < 0.0001), and renal function was unchanged in both treatment groups. There was no effect of age on glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment did not affect the pharmacokinetics of semaglutide. Across the trials, the safety profile of oral semaglutide was as expected for a GLP-1RA, with gastrointestinal adverse events most commonly reported. As such, oral semaglutide provides an effective oral GLP-1RA treatment option in older patients and/or those with comorbidities, with no requirements for dose adjustment.",2020,There was no effect of age on glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment did not affect the pharmacokinetics of semaglutide.,"['older patients and/or those with comorbidities', 'patients with comorbidities', 'patients at high cardiovascular risk', 'Patients with type 2 diabetes (T2D) often have comorbidities, such as cardiovascular disease or chronic kidney disease, and a large and growing proportion of the T2D patient population is over 65 years', 'patients with type 2 diabetes and cardiovascular disease, renal impairment, or other comorbidities, and in older patients', 'patients with moderate renal impairment']","['Oral semaglutide', 'ETD', 'placebo']","['renal function', 'body weight', 'glycated hemoglobin', 'cardiovascular safety of oral semaglutide', 'safety profile of oral semaglutide', 'glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}]",,0.0838752,There was no effect of age on glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment did not affect the pharmacokinetics of semaglutide.,"[{'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Faculty of Medicine, Hebrew University of Jerusalem , Jerusalem, Israel.'}, {'ForeName': 'Eden M', 'Initials': 'EM', 'LastName': 'Miller', 'Affiliation': 'Diabetes Nation , Bend, OR, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Warren', 'Affiliation': 'Physicians East , Greenville, NC, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1800286']
2612,32819528,Quality of Life and Health Care Utilization in the CIRCA-DOSE Study.,"OBJECTIVES
This study evaluated the impact of contact force-guided radiofrequency ablation versus cryoballoon ablation on quality of life and health care utilization.
BACKGROUND
Traditional outcome parameters, such as arrhythmia-free survival, are insufficient to evaluate the clinical impact of atrial fibrillation (AF), as it fails to the capture patient- and health system-level differences in treatment approaches.
METHODS
The CIRCA-DOSE (Cryoballoon Vs. Contact-Force Atrial Fibrillation Ablation) study randomly assigned 346 patients with drug-refractory paroxysmal AF to contact force-guided radiofrequency or cryoballoon ablation. Health-related quality-of-life (HRQOL) was assessed at baseline, and at 6 and 12 months post-ablation using a disease-specific and generic HRQOL instruments. Health care utilization (hospitalization, emergency department visits, and cardioversion) and antiarrhythmic drug use for the 12 months preceding ablation was compared with the 12 months following ablation.
RESULTS
Disease-specific and generic HRQOL was moderately to severely impaired at baseline and improved significantly at 6 and 12 months of follow-up (median improvement in AFEQT [Atrial Fibrillation Effect on QualiTy of Life] score 32.4 [interquartile range: 17.7 to 48.9]). When compared with the 12 months pre-ablation, the proportion and absolute number of cardioversions decreased significantly (41.1% vs. 10.1% of patients, 137 vs. 35 events; p < 0.0001). Similar significant reductions in emergency department visits (66.7% vs. 25.1% of patients, 224 vs. 87 events; p < 0.0001), and hospitalizations (25.5% vs. 14.5% of patients, 86 vs. 50 events; p < 0.001) were observed. There were no significant differences between randomized groups.
CONCLUSIONS
In this multicenter randomized trial, catheter ablation with advanced-generation technologies resulted in a significant improvement in HRQOL and a significant reduction in health care utilization in the year following AF ablation. (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation [CIRCA-DOSE]; NCT01913522).",2020,"Similar significant reductions in emergency department visits (66.7% vs. 25.1% of patients, 224 vs. 87 events; p < 0.0001), and hospitalizations (25.5% vs. 14.5% of patients, 86 vs. 50 events; p < 0.001) were observed.",['346 patients with drug-refractory paroxysmal AF to'],"['Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation [CIRCA-DOSE', 'contact force-guided radiofrequency or cryoballoon ablation', 'catheter ablation with advanced-generation technologies', 'contact force-guided radiofrequency ablation versus cryoballoon ablation', 'AFEQT']","['Health care utilization (hospitalization, emergency department visits, and cardioversion) and antiarrhythmic drug use', 'Quality of Life and Health Care Utilization', 'emergency department visits', 'quality of life and health care utilization', 'HRQOL', 'proportion and absolute number of cardioversions', 'health care utilization', 'hospitalizations', 'Health-related quality-of-life (HRQOL', 'Disease-specific and generic HRQOL', 'QualiTy of Life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}]","[{'cui': 'C0162561', 'cui_str': 'Radiofrequency Catheter Ablation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",346.0,0.0820205,"Similar significant reductions in emergency department visits (66.7% vs. 25.1% of patients, 224 vs. 87 events; p < 0.0001), and hospitalizations (25.5% vs. 14.5% of patients, 86 vs. 50 events; p < 0.001) were observed.","[{'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada; Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: jason.andrade@vch.ca.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Department of Medicine, Southlake Regional Health Center, Newmarket, Ontario, Canada.'}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Champagne', 'Affiliation': 'Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dubuc', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Leong-Sit', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': 'Department of Medicine, Royal Jubilee Hospital, Victoria, British Columbia, Canada.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Roux', 'Affiliation': 'Department of Medicine, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sapp', 'Affiliation': 'Department of Medicine, Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Khoo', 'Affiliation': 'Department of Medicine, St. Boniface Hospital, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Rizkallah', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Levesque', 'Affiliation': 'Montreal Health Innovations Coordinating Centre, Montreal, Québec, Canada.'}, {'ForeName': 'Anthony S L', 'Initials': 'ASL', 'LastName': 'Tang', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada; Montreal Health Innovations Coordinating Centre, Montreal, Québec, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2020.04.017']
2613,32820015,Entospletinib in Combination with Induction Chemotherapy in Previously Untreated Acute Myeloid Leukemia: Response and Predictive Significance of HOXA9 and MEIS1 Expression.,"PURPOSE
Spleen tyrosine kinase (SYK) signaling is a proposed target in acute myeloid leukemia (AML). Sensitivity to SYK inhibition has been linked to HOXA9 and MEIS1 overexpression in preclinical studies. This trial evaluated the safety and efficacy of entospletinib, a selective inhibitor of SYK, in combination with chemotherapy in untreated AML.
PATIENTS AND METHODS
This was an international multicenter phase Ib/II study, entospletinib dose escalation (standard 3+3 design between 200 and 400 mg twice daily) + 7+3 (cytarabine + daunorubicin) in phase Ib and entospletinib dose expansion (400 mg twice daily) + 7+3 in phase II.
RESULTS
Fifty-three patients ( n = 12, phase Ib and n = 41, phase II) with previously untreated de novo ( n = 39) or secondary ( n = 14) AML were enrolled (58% male; median age, 60 years) in this study. The composite complete response with entospletinib + 7+3 was 70%. Patients with baseline HOXA9 and MEIS1 expression higher than the median had improved overall survival compared with patients with below median HOXA9 and MEIS1 expression. Common adverse events were cytopenias, febrile neutropenia, and infection. There were no dose-limiting toxicities. Entospletinib-related skin rash and hyperbilirubinemia were also observed.
CONCLUSIONS
Entospletinib with intensive chemotherapy was well-tolerated in patients with AML. Improved survival was observed in patients with HOXA9/MEIS1 overexpression, contrasting published data demonstrating poor survival in such patients. A randomized study will be necessary to determine whether entospletinib was a mediator this observation.",2020,Patients with baseline HOXA9 and MEIS1 expression higher than the median had improved overall survival compared to patients with below median HOXA9 and MEIS1 expression.,"['Fifty-three patients (n=12 phase 1b, n=41 phase 2) with previously untreated de novo (n=39) or secondary (n=14) AML enrolled (58% male, median age 60 years', 'acute myeloid leukemia (AML']","['entospletinib dose escalation (standard 3+3 design between 200 mg and 400 mg BID) + 7+3 (cytarabine + daunorubicin', 'Induction Chemotherapy', 'Entosplentib with intensive chemotherapy']","['Entospletinib-related skin rash and hyperbilirubinemia', 'febrile neutropenia, and infection', 'no dose-limiting toxicities', 'overall survival', 'Improved survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3179739', 'cui_str': 'lanthanum citrate'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0519043,Patients with baseline HOXA9 and MEIS1 expression higher than the median had improved overall survival compared to patients with below median HOXA9 and MEIS1 expression.,"[{'ForeName': 'Alison R', 'Initials': 'AR', 'LastName': 'Walker', 'Affiliation': 'The Ohio State University, Columbus, Ohio. Alison.Walker@osumc.edu.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Blachly', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Bhavana', 'Initials': 'B', 'LastName': 'Bhatnagar', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Alice S', 'Initials': 'AS', 'LastName': 'Mims', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Orwick', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Tara L', 'Initials': 'TL', 'LastName': 'Lin', 'Affiliation': 'University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Howland E', 'Initials': 'HE', 'LastName': 'Crosswell', 'Affiliation': 'Bon Secours Mercy Health System, Greenville, South Carolina.'}, {'ForeName': 'Danjie', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Minden', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Veerendra', 'Initials': 'V', 'LastName': 'Munugalavadla', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Long', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Oellerich', 'Affiliation': 'Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Serve', 'Affiliation': 'Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Arati V', 'Initials': 'AV', 'LastName': 'Rao', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Blum', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, Georgia.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1064']
2614,32825070,Incentivizing Commuter Cycling by Financial and Non-Financial Rewards.,"Current mobility patterns over-rely on transport modes that do not benefit sustainable and healthy lifestyles. To explore the potential for active mobility, we conducted a randomized experiment aimed at increasing regular commuter cycling in cities. In designing the experiment, we teamed up with developers of the ""Cyclers"" smartphone app to improve the effectiveness of the app by evaluating financial and non-financial motivational features. Participants in the experiment were recruited among new users of the app, and were randomly assigned to one of four different motivational treatments (smart gamification, two variants of a financial reward, and a combination of smart gamification and a financial reward) or a control group (no specific motivation). Our analysis suggests that people can be effectively motivated to engage in more frequent commuter cycling with incentives via a smartphone app. Offering small financial rewards seems to be more effective than smart gamification. A combination of both motivational treatments-smart gamification and financial rewards-may work the same or slightly better than financial rewards alone. We demonstrate that small financial rewards embedded in smartphone apps such as ""Cyclers"" can be effective in nudging people to commute by bike more often.",2020,"Participants in the experiment were recruited among new users of the app, and were randomly assigned to one of four different motivational treatments (smart gamification, two variants of a financial reward, and a combination of smart gamification and a financial reward) or a control group (no specific motivation).","['Participants in the experiment were recruited among new users of the app', 'cities']","['motivational treatments (smart gamification, two variants of a financial reward, and a combination of smart gamification and a financial reward) or a control group (no specific motivation']",[],"[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",[],,0.0338274,"Participants in the experiment were recruited among new users of the app, and were randomly assigned to one of four different motivational treatments (smart gamification, two variants of a financial reward, and a combination of smart gamification and a financial reward) or a control group (no specific motivation).","[{'ForeName': 'Vojtěch', 'Initials': 'V', 'LastName': 'Máca', 'Affiliation': 'Environment Centre, Charles University, 162 00 Prague, Czech Republic.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Ščasný', 'Affiliation': 'Environment Centre, Charles University, 162 00 Prague, Czech Republic.'}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Zvěřinová', 'Affiliation': 'Environment Centre, Charles University, 162 00 Prague, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Jakob', 'Affiliation': 'FEE, Artificial Intelligence Center, Czech Technical University in Prague, 121 35 Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hrnčíř', 'Affiliation': 'Umotional s.r.o., 120 00 Prague, Czech Republic.'}]",International journal of environmental research and public health,['10.3390/ijerph17176033']
2615,32825282,Impact of Nurses' Intervention in the Prevention of Falls in Hospitalized Patients.,"BACKGROUND
Clinical safety is a crucial component of healthcare quality, focused on identifying and avoiding the risks to which patients are exposed. Among the adverse events that occur in a hospital environment, falls have a large impact (1.9-10% of annual income in acute care hospitals); they can cause pain, damage, costs, and mistrust in the health system. Our objective was to assess the effect of an educational intervention aimed at hospital nurses (systematic assessment of the risk of falls) in reducing the incidence of falls.
METHODS
this was a quasi-experimental study based on a sample of 581 patients in a third level hospital (Comunitat Valenciana, Spain). An educational program was given to the intervention group ( n = 303), and a control group was included for comparison ( n = 278). In the intervention group, the nurses participated in a training activity on the systematized assessment of the risk of falls. Analysis was undertaken using the Bayesian logistic regression model.
RESULTS
a total of 581 patients were studied (50.6% male, 49.4% female), with an average age of 68.3 (DT = 9) years. The overall incidence of falls was 1.2% (0.3% in the intervention group and 2.2% in the control group). Most of the falls occurred in people ≥65 years old (85.7%). The intervention group had a lower probability of falling than the control group (OR: 0.127; IC95%: 0.013-0.821). Neither the length of hospital stay, nor the age of the participants, had any relevant effect.
CONCLUSIONS
the systematic assessment of the risk of a patient falling during hospital processes is an effective intervention to reduce the incidence of falls.",2020,The intervention group had a lower probability of falling than the control group (OR: 0.127; IC95%: 0.013-0.821).,"['Hospitalized Patients', 'a total of 581 patients were studied (50.6% male, 49.4% female), with an average age of 68.3 (DT = 9) years', '581 patients in a third level hospital (Comunitat Valenciana, Spain']","['educational intervention', ""Nurses' Intervention""]","['lower probability of falling', 'length of hospital stay', 'overall incidence of falls']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",581.0,0.0392586,The intervention group had a lower probability of falling than the control group (OR: 0.127; IC95%: 0.013-0.821).,"[{'ForeName': 'Raimunda', 'Initials': 'R', 'LastName': 'Montejano-Lozoya', 'Affiliation': 'Escuela Enfermería La Fe, Valencia (Spain), adscript center of Universitat de Valencia, Research Group GREIACC, Health Research Institute La Fe, 46026 Valencia, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Miguel-Montoya', 'Affiliation': 'Escuela Enfermería La Fe, Valencia (Spain), adscript center of Universitat de Valencia, Research Group GREIACC, Health Research Institute La Fe, 46026 Valencia, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Gea-Caballero', 'Affiliation': 'Escuela Enfermería La Fe, Valencia (Spain), adscript center of Universitat de Valencia, Research Group GREIACC, Health Research Institute La Fe, 46026 Valencia, Spain.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Mármol-López', 'Affiliation': 'Escuela Enfermería La Fe, Valencia (Spain), adscript center of Universitat de Valencia, Research Group GREIACC, Health Research Institute La Fe, 46026 Valencia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ruíz-Hontangas', 'Affiliation': 'Escuela Enfermería La Fe, Valencia (Spain), adscript center of Universitat de Valencia, Research Group GREIACC, Health Research Institute La Fe, 46026 Valencia, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Ortí-Lucas', 'Affiliation': 'Public Health Department, Catholic University of Valencia, 46001 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17176048']
2616,32822827,A community-based asthma program: Study design and methods of RVA Breathes.,"Disparities in pediatric asthma morbidity and healthcare utilization exist on the basis of race, ethnicity, environment, and income; interventions are needed to address these inequities. The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors. Community stakeholder feedback was utilized to refine the intervention specifically for the Richmond, Virginia community. The aims of this study are to assess the effect of RVA Breathes on asthma-related healthcare utilization, as well as secondary outcomes of asthma control, asthma symptoms, and quality of life. We will enroll 300 elementary school children from the Richmond City Public School system. Participants will be between the ages of 5-11, have a diagnosis of asthma, and have had an asthma exacerbation (as indicated by an asthma-related ED visit, hospitalization, unscheduled PCP visit, or use of systemic steroids) in the last two years. Participants will be randomized to one of three groups: asthma education + home environment remediation + school intervention, asthma education + home environment remediation, or a comparator condition. Data will be collected across one baseline research visit, four intervention sessions, and four follow-up research visits over the course of 18 months. A General Linear Mixed Model (GLMM) will be used to test primary aims. We expect the findings will provide support for coordination of asthma care across sectors. Further, we hope RVA Breathes will serve as a model of community-based pediatric asthma care.",2020,"The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors.","['Participants will be between the ages of 5-11, have a diagnosis of asthma, and have had an asthma exacerbation (as indicated by an asthma-related ED visit, hospitalization, unscheduled PCP visit, or use of systemic steroids) in the last two years', '300 elementary school children from the Richmond City Public School system']","['asthma education + home environment remediation + school intervention, asthma education + home environment remediation, or a comparator condition', 'RVA']","['asthma control, asthma symptoms, and quality of life']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",300.0,0.0360733,"The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors.","[{'ForeName': 'Robin S', 'Initials': 'RS', 'LastName': 'Everhart', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America. Electronic address: reverhart@vcu.edu.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mazzeo', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Corona', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Holder', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Leroy R', 'Initials': 'LR', 'LastName': 'Thacker', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Schechter', 'Affiliation': ""Children's Hospital of Richmond at VCU, Richmond, VA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106121']
2617,32822968,"Improvement in overall survival with Apalutamide, Darolutamide and Enzalutamide in patients with non-metastatic castration-resistant prostate cancer.","Since 2018, apalutamide, darolutamide, and enzalutamide have been approved for the treatment of men with non-metastatic castration-resistant prostate cancer (M0CRPC). These approvals were based on the results of three separate randomized, placebo-controlled, phase III trials: SPARTAN (apalutamide), ARAMIS (darolutamide) and PROSPER (enzalutamide). These trials included men with M0CRPC and a short PSA doubling time (≤10 months). Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone. Updated results of these trials presented in the 2020 annual meeting of American Society of Oncology (ASCO) showed significantly improved overall survival with these agents. Based on these results, apalutamide, darolutamide, and enzalutamide can now be considered the standard of care treatment options for the treatment of men with M0CRPC.",2020,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","['men with M0CRPC and a short PSA doubling time (≤10 months', 'men with non-metastatic castration-resistant prostate cancer (M0CRPC', 'men with M0CRPC', 'patients with non-metastatic castration-resistant prostate cancer']","['Apalutamide, Darolutamide and Enzalutamide', 'ARAMIS (darolutamide) and PROSPER (enzalutamide', 'androgen deprivation therapy (ADT', 'placebo']","['overall survival', 'longer metastasis-free survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.0449496,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","[{'ForeName': 'Umang', 'Initials': 'U', 'LastName': 'Swami', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA. Electronic address: umang.swami@hci.utah.edu.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2020.100205']
2618,32827953,The strap intermuscular approach can significantly increase the exposure rate of the external branch of the superior laryngeal nerve during thyroid surgery.,"BACKGROUND
Avoiding injury to the external branch of the superior laryngeal nerve (EBSLN) is a major challenge during thyroid surgery. EBSLN injury can have an impact on the quality of life of patients. The aim of this study was to introduce the strap intermuscular approach, to dissect the EBSLN with two different approaches in thyroid surgery, to compare the differences between these two approaches, and to describe a way for surgeons to treat the upper thyroid gland to find the EBSLN.
METHODS
A prospective study of hemithyroidectomy was performed. In total, 104 patients were included and randomly divided into two groups: one group used the traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach. We described the surgical procedure for the strap intermuscular approach and compared the differences in the rates of EBSLN exposure, injury, and classification to illustrate the advantages of the intermuscular approach in thyroid surgery.
RESULTS
The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630). The exposure rate of EBSLNs classified as type 1 was higher in the strap intermuscular approach than in the traditional approach (30.77% vs. 13.46%, p = 0.033), with an OR and 95% CI of 0.350 (0.130-0.942).
CONCLUSIONS
The exposure rate of the EBSLN was significantly higher with the strap intermuscular approach method than with the traditional approach during thyroid surgery. This approach allows for better identification of the EBSLN during thyroidectomy.",2020,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).",['104 patients'],"['traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach', 'hemithyroidectomy']",['exposure rate of the EBSLN'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183631', 'cui_str': 'Strap'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}]",104.0,0.0387604,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Hei', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Songtao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Runfang', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Jianwu', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. Electronic address: qinjianwu_62@163.com.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.004']
2619,32828130,"Does a ketogenic diet have beneficial effects on quality of life, physical activity or biomarkers in patients with breast cancer: a randomized controlled clinical trial.","INTRODUCTION
Despite recent interest in the use of ketogenic diets (KDs) for cancer, evidence of beneficial effects is lacking. This study examined the impact of a randomly assigned KD on quality of life, physical activity and biomarkers in patients with breast cancer.
METHOD
A total of 80 patients with locally advanced or metastatic breast cancer and without a history of renal disease or diabetes were randomly assigned to either a KD or a control group for this 12-week trial. Concurrent with the first, third, and fifth chemotherapy sessions, quality of life, physical activity, and biomarkers (thyroid function tests, electrolytes, albumin, ammonia, ALP, lactate and serum ketones) were assessed. Dietary intake was also recorded on admission and the end of the treatment.
RESULTS
No significant differences were seen in quality of life or physical activity scores between the two groups after 12 weeks; however, the KD group showed higher global quality of life and physical activity scores compared to the control group at 6 weeks (P = 0.02 P = 0.01). Also, serum lactate and ALP levels decreased significantly in the KD group compared to the control group at the end of the intervention (10.7 ± 3 vs 13.3 ± 4, 149 ± 71 vs 240 ± 164, P = 0.02 and P = 0.007, respectively). A significant inverse association was observed between total carbohydrate intake and serum beta-hydroxybutyrate at 12 weeks (r = - 0.77 P < 0.001). No significant differences between groups were observed in thyroid hormones, electrolytes, albumin, LDH or ammonia. Compliance among KD subjects ranged from 66.7 to 79.2% as assessed by dietary intake and serum ketones levels of > 0.5.
CONCLUSION
According to our results, besides a higher global quality of life and physical activity scores compared to the control group at 6 weeks, KD diet combined to chemotherapy in patients with breast cancer does not bring additional benefit about quality of life and physical activity at 12 weeks. However, decreases seen in levels of lactate and ALP in the KD group suggest that a KD may benefit patients with breast cancer.
TRIAL REGISTRATION
This trial has been registered on Iranian Registry of Clinical Trials (IRCT) under the identification code: IRCT20171105037259N2 https://www.irct.ir/trial/30755.",2020,"No significant differences were seen in quality of life or physical activity scores between the two groups after 12 weeks; however, the KD group showed higher global quality of life and physical activity scores compared to the control group at 6 weeks (P = 0.02 P = 0.01).","['80 patients with locally advanced or metastatic breast cancer and without a history of renal disease or diabetes', 'patients with breast cancer']","['KD', 'KD diet combined to chemotherapy']","['serum lactate and ALP levels', 'levels of lactate and ALP', 'quality of life, physical activity or biomarkers', 'total carbohydrate intake and serum beta-hydroxybutyrate', 'thyroid hormones, electrolytes, albumin, LDH or ammonia', 'quality of life or physical activity scores', 'Dietary intake', 'quality of life, physical activity, and biomarkers (thyroid function tests, electrolytes, albumin, ammonia, ALP, lactate and serum ketones', 'quality of life, physical activity and biomarkers', 'dietary intake and serum ketones levels', 'global quality of life and physical activity scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0455686', 'cui_str': 'H/O: kidney disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0428446', 'cui_str': 'Serum lactate measurement'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0040130', 'cui_str': 'Thyroid panel'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C1303221', 'cui_str': 'Serum ketone level'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",80.0,0.0266931,"No significant differences were seen in quality of life or physical activity scores between the two groups after 12 weeks; however, the KD group showed higher global quality of life and physical activity scores compared to the control group at 6 weeks (P = 0.02 P = 0.01).","[{'ForeName': 'Adeleh', 'Initials': 'A', 'LastName': 'Khodabakhshi', 'Affiliation': 'Department of Nutrition, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Seyfried', 'Affiliation': 'Biology Department, Boston College, Chestnut Hill, MA, USA.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Kalamian', 'Affiliation': 'Dietary Therapies LLC, Hamilton, MT, USA.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Beheshti', 'Affiliation': ""Department of Nutrition and Dietetics, Mofid children's hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Sayed Hossein', 'Initials': 'SH', 'LastName': 'Davoodi', 'Affiliation': 'Cancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. khodabakhshiadeleh@yahoo.com.'}]",Nutrition journal,['10.1186/s12937-020-00596-y']
2620,31816049,History and Correlates of Smoking Cessation Behaviors Among Smokers With Serious Mental Illness.,"INTRODUCTION
Individuals with serious mental illness (SMI) smoke at rates two to three times greater than the general population but are less likely to receive treatment. Increasing our understanding of correlates of smoking cessation behaviors in this group can guide intervention development.
AIMS AND METHODS
Baseline data from an ongoing trial involving smokers with SMI (N = 482) were used to describe smoking cessation behaviors (ie, quit attempts, quit motivation, and smoking cessation treatment) and correlates of these behaviors (ie, demographics, attitudinal and systems-related variables).
RESULTS
Forty-three percent of the sample did not report making a quit attempt in the last year, but 44% reported making one to six quit attempts; 43% and 20%, respectively, reported wanting to quit within the next 6 months or the next 30 days. Sixty-one percent used a smoking cessation medication during their quit attempt, while 13% utilized counseling. More quit attempts were associated with lower nicotine dependence and carbon monoxide and greater beliefs about the harms of smoking. Greater quit motivation was associated with lower carbon monoxide, minority race, benefits of cessation counseling, and importance of counseling within the clinic. A greater likelihood of using smoking cessation medications was associated with being female, smoking more cigarettes, and receiving smoking cessation advice. A greater likelihood of using smoking cessation counseling was associated with being male, greater academic achievement, and receiving smoking cessation advice.
CONCLUSIONS
Many smokers with SMI are engaged in efforts to quit smoking. Measures of smoking cessation behavior are associated with tobacco use indicators, beliefs about smoking, race and gender, and receiving cessation advice.
IMPLICATIONS
Consideration of factors related to cessation behaviors among smokers with SMI continues to be warranted, due to their high smoking rates compared to the general population. Increasing our understanding of these predictive characteristics can help promote higher engagement in evidence-based smoking cessation treatments among this subpopulation.",2020,More quit attempts were associated with lower nicotine dependence and carbon monoxide and greater beliefs about the harms of smoking.,"['Smokers', 'Baseline data from an ongoing trial involving smokers with SMI (N = 482', 'smokers with SMI']",[],"['smoking cessation behaviors', 'Smoking Cessation Behaviors', 'Greater quit motivation', 'smoking cessation medication']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",[],"[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",482.0,0.0126191,More quit attempts were associated with lower nicotine dependence and carbon monoxide and greater beliefs about the harms of smoking.,"[{'ForeName': 'Su Fen', 'Initials': 'SF', 'LastName': 'Lubitz', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Flitter', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'E Paul', 'Initials': 'EP', 'LastName': 'Wileyto', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Ziedonis', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, CA.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Stevens', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Leone', 'Affiliation': 'Department of Medicine, Pulmonary, Allergy, & Critical Care Division, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mandell', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kimberly', 'Affiliation': 'Department of Management, The Wharton School of Business, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Rinad', 'Initials': 'R', 'LastName': 'Beidas', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz229']
2621,31820002,Motivational Interviewing to Encourage Quit Attempts Among Smokers Not Ready to Quit: A Trial-Based Economic Analysis.,"INTRODUCTION
This study used data from a randomized controlled trial evaluating the efficacy of motivational interviewing (MI) relative to health education (HE) and brief advice (BA) to encourage quit attempts and cessation in order to determine their relative cost-effectiveness.
AIMS AND METHODS
Urban community residents (n = 255) with low desire to quit smoking were randomized to MI, HE, or BA which differed in communication style and/or number of treatment sessions. Incremental cost-effectiveness ratios were used to compare the intensive interventions (MI and HE) to BA for facilitating quit attempts and smoking cessation. Costs were calculated from the perspective of an agency that might engage in program delivery. Sensitivity analysis examined different assumptions for MI training and pharmacotherapy costs.
RESULTS
Total intervention delivery time costs per participant for MI, HE, and BA were $46.63, $42.87, and $2.4, respectively. Cost-effectiveness ratios per quit attempt at 24 weeks were $380 for MI, $272 for HE, and $209 for BA. The cost per additional quit attempt for MI and HE relative to BA was $508 and $301, respectively. The cost per additional quit for MI and HE relative to BA was $2030 and $752, respectively. Four separate sensitivity analyses conducted in our study did not change the conclusion the HE had a lower Incremental Cost-Effectiveness Ratio for both quit attempts and cessation.
CONCLUSIONS
HE was the most cost-effective of the three types of smoking cessation induction therapies and therefore may be preferable for smokers who are less motivated to quit. Providing valuable cost information in choosing different clinical methods for motivating smokers to quit.
IMPLICATIONS
All direct costs and activity-based time costs associated with delivering the intervention were analyzed from the perspective of an agency that may wish to replicate these strategies. A randomized controlled trial evaluating the efficacy of MI relative to HE and BA to encourage quit attempts and cessation determined their relative cost-effectiveness. HE was the most cost-effective of the three types of smoking cessation induction therapies and therefore may be preferable. Despite guideline recommendations, MI may not be the best approach to encourage quit attempts in diverse populations. Rather, a structured, intensive HE intervention might be the most cost-effective alternative.",2020,HE was the most cost-effective of the three types of smoking cessation induction therapies and therefore may be preferable for smokers who are less motivated to quit.,"['Quit', 'Smokers', 'Urban community residents (n = 255) with low desire to quit smoking']","['Motivational Interviewing', 'MI relative to HE and BA', 'motivational interviewing (MI) relative to health education (HE) and brief advice (BA']","['Incremental cost-effectiveness ratios', 'cost per additional quit for MI and HE relative to BA', 'Total intervention delivery time costs per participant for MI, HE, and BA', 'Incremental Cost-Effectiveness Ratio', 'cost per additional quit attempt for MI and HE relative to BA', 'Cost-effectiveness ratios per quit attempt']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1301668', 'cui_str': 'Time of delivery'}]",255.0,0.0521855,HE was the most cost-effective of the three types of smoking cessation induction therapies and therefore may be preferable for smokers who are less motivated to quit.,"[{'ForeName': 'Rafia S', 'Initials': 'RS', 'LastName': 'Rasu', 'Affiliation': 'University of North Texas Health Science Center, Fort Worth, TX.'}, {'ForeName': 'Joanie', 'Initials': 'J', 'LastName': 'Thelen', 'Affiliation': 'University of Missouri-Kansas City, Kansas City, MO.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Agbor Bawa', 'Affiliation': 'University of North Texas Health Science Center, Fort Worth, TX.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bradley-Ewing', 'Affiliation': ""Division of Health Services and Outcomes Research, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, Children's Mercy Kansas City, Kansas City, MO.""}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz228']
2622,32830553,Hyperglycemia does not Inhibit Insulin's Effects on Microvascular Perfusion in Healthy Humans: A Randomized Crossover Study.,"Diabetes mellitus accelerates vascular disease through multiple biochemical pathways driven by hyperglycemia, with insulin resistance and/or hyperinsulinemia also contributing. Persons with diabetes mellitus experience premature large vessel and microvascular disease when compared to normoglycemic controls. Currently there is a paucity of clinical data identifying how acutely the vasculature responds to hyperglycemia and whether other physiologic factors (e.g., vasoactive hormones) contribute. To our knowledge, no prior studies have examined the dynamic effects of acute hyperglycemia on insulin-mediated actions on both micro- and macrovascular function in the same subjects. In this randomized crossover trial, healthy young adults underwent two infusion protocols designed to compare the effects of insulin infusion during euglycemia and hyperglycemia on micro- and macrovascular function. Both euglycemic- and hyperglycemic-hyperinsulinemia increased skeletal (but not cardiac) muscle microvascular blood volume (each p<0.02) and blood flow significantly (each p<0.04), and these increases did not differ between protocols. Hyperglycemic-hyperinsulinemia trended towards increased carotid-femoral pulse wave velocity (indicating increased aortic stiffness; p= 0.065 after Bonferroni adjustment), while euglycemic-hyperinsulinemia did not. There were no changes in post-ischemic flow velocity or brachial artery flow-mediated dilation during either protocol. Plasma endothelin-1 levels significantly decreased during both protocols (each p<0.02). In this study, acute hyperglycemia for 4 hours did not inhibit insulin's ability to increase skeletal muscle microvascular perfusion but did provoke a slight increase in aortic stiffness. Hyperglycemia also did not adversely affect myocardial microvascular perfusion or endothelial function or prevent the decline of endothelin-1 during insulin infusion.",2020,Hyperglycemia also did not adversely affect myocardial microvascular perfusion or endothelial function or prevent the decline of endothelin-1 during insulin infusion.,"['healthy young adults', 'Persons with diabetes mellitus', 'Healthy Humans']",['insulin infusion during euglycemia and hyperglycemia'],"['blood flow', 'myocardial microvascular perfusion or endothelial function', 'Hyperglycemia', 'Plasma endothelin-1 levels', 'cardiac) muscle microvascular blood volume', 'euglycemic-hyperinsulinemia', 'post-ischemic flow velocity or brachial artery flow-mediated dilation', 'aortic stiffness', 'Hyperglycemic-hyperinsulinemia', 'carotid-femoral pulse wave velocity']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",,0.0219329,Hyperglycemia also did not adversely affect myocardial microvascular perfusion or endothelial function or prevent the decline of endothelin-1 during insulin infusion.,"[{'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Horton', 'Affiliation': 'Medicine, University of Virginia, United States.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Jahn', 'Affiliation': 'endocrinology, University of Virginia, United States.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Hartline', 'Affiliation': 'University of Virginia, United States.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Aylor', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Department of Pharmacology , University of Virginia, School of Medicine, Charlottesville, VA 22908; Department of Molecular and Clinical Medicine (.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Patrie', 'Affiliation': 'Public Health Sciences, University of Virginia Medical Center, United States.'}, {'ForeName': 'Eugene J', 'Initials': 'EJ', 'LastName': 'Barrett', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Department of Pharmacology , University of Virginia, School of Medicine, Charlottesville, VA 22908; Department of Molecular and Clinical Medicine (, United States.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00300.2020']
2623,32838555,Intent-to-treat analysis of cluster randomized trials when clusters report unidentifiable outcome proportions.,"BACKGROUND
Cluster randomized trials are designed to evaluate interventions at the cluster or group level. When clusters are randomized but some clusters report no or non-analyzable data, intent-to-treat analysis, the gold standard for the analysis of randomized controlled trials, can be compromised. This article presents a very flexible statistical methodology for cluster randomized trials whose outcome is a cluster-level proportion (e.g. proportion from a cluster reporting an event) in the setting where clusters report non-analyzable data (which in general could be due to nonadherence, dropout, missingness, etc.). The approach is motivated by a previously published stratified randomized controlled trial called, ""The Randomized Recruitment Intervention Trial (RECRUIT),"" designed to examine the effectiveness of a trust-based continuous quality improvement intervention on increasing minority recruitment into clinical trials (ClinicalTrials.gov Identifier: NCT01911208).
METHODS
The novel approach exploits the use of generalized estimating equations for cluster-level reports, such that all clusters randomized at baseline are able to be analyzed, and intervention effects are presented as risk ratios. Simulation studies under different outcome missingness scenarios and a variety of intra-cluster correlations are conducted. A comparative analysis of the method with imputation and per protocol approaches for RECRUIT is presented.
RESULTS
Simulation results show the novel approach produces unbiased and efficient estimates of the intervention effect that maintain the nominal type I error rate. Application to RECRUIT shows similar effect sizes when compared to the imputation and per protocol approach.
CONCLUSION
The article demonstrates that an innovative bivariate generalized estimating equations framework allows one to implement an intent-to-treat analysis to obtain risk ratios or odds ratios, for a variety of cluster randomized designs.",2020,"RESULTS
Simulation results show the novel approach produces unbiased and efficient estimates of the intervention effect that maintain the nominal type I error rate.",[],['trust-based continuous quality improvement intervention'],[],[],"[{'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.232914,"RESULTS
Simulation results show the novel approach produces unbiased and efficient estimates of the intervention effect that maintain the nominal type I error rate.","[{'ForeName': 'Stacia M', 'Initials': 'SM', 'LastName': 'DeSantis', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Ruosha', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Yefei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Sally W', 'Initials': 'SW', 'LastName': 'Vernon', 'Affiliation': 'Department of Health Promotions and Behavioral Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Tilley', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Koch', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520936668']
2624,32835958,Enhancing extinction with response prevention via imagery-based counterconditioning: Results on conditioned avoidance and distress.,"BACKGROUND AND OBJECTIVES
Maladaptive avoidance is a core characteristic of anxiety-related disorders. Its reduction is often promoted using extinction with response prevention (ExRP) procedures, but these effects are often short-lived. Research has shown that pairing a feared stimulus with a stimulus of an incompatible valence (i.e., counterconditioning) may be effective in reducing fear. This laboratory study tested whether positive imagery during ExRP (i.e., imagery counterconditioning protocol) can also reduce avoidance.
METHODS
In the counterconditioning procedure, participants imagined a positive sound. There were four phases. First, participants were presented with squares on a computer screen of which one (CS+) was paired with an aversive sound and another (CS-) was not. Second, they learned to avoid the negative sound in the presence of the CS+, via a key press. Third, they were assigned to either the Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP). Finally, they performed a test phase that consisted of two parts: in the first part, avoidance responses were available for each CS and in the second part, these responses were prevented.
RESULTS
The Counterconditioning intervention resulted in a short-lived reduction of distress associated with the CS+. However, groups did not differ in avoidance or distress during the test phases.
LIMITATIONS
US-expectancy ratings were collected only at the end of the experiment.
CONCLUSIONS
The results indicate that positive imagery during ExRP may be effective in reducing distress during the intervention. Explanations for the persistence of avoidance and fear are discussed.",2020,"However, groups did not differ in avoidance or distress during the test phases.
",[],['Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP'],"['avoidance or distress', 'distress']",[],"[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.037803,"However, groups did not differ in avoidance or distress during the test phases.
","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Hendrikx', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}, {'ForeName': 'Angelos-Miltiadis', 'Initials': 'AM', 'LastName': 'Krypotos', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands; Department of Healthy Psychology, KU Leuven, Belgium. Electronic address: amkrypotos@gmail.com.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'Engelhard', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101601']
2625,32871529,"Changes in glenohumeral translation, electromyographic activity, and pressure-pain thresholds following sustained or oscillatory mobilizations in stiff and healthy shoulders: Results of a randomized, controlled laboratory trial.","STUDY DESIGN
Randomized Controlled Laboratory Study.
BACKGROUND
Posterior glide glenohumeral (GH) mobilizations are utilized to improve motion and decrease pain in patients with shoulder pathologies, thought to be due to capsular stretch and neurophysiologic effects. However, it remains unclear how different GH mobilizations influence mobility, rotator cuff (RC) activity, and pain processing, or if effects are different in stiff (≥15-degree loss of passive motion in any plane) rather than healthy shoulders.
OBJECTIVES
To compare the effects of oscillatory and sustained posterior GH mobilizations on translation, RC activity, and pressure pain threshold (PPT) in stiff and healthy shoulders.
METHODS
Eighty-eight participants, (44 control, 44 stiff shoulders) were randomly assigned to one of two mobilization conditions. Pre-post intervention measurements of PPT, GH translation via ultrasound imaging, and RC activity assessed via electromyography were performed. Sustained or oscillatory grade III posterior GH mobilizations were then provided to all participants. Data were analyzed using tests of difference and regression modeling.
RESULTS
Sustained glides (2.8 ± 3.3 mm) demonstrated significantly greater changes in translation compared to oscillatory glides (1.1 ± 3.9 mm), p = .028. Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01). Small changes in PPT occurred across all conditions, none reaching clinically meaningful levels.
CONCLUSION
Sustained mobilizations resulted in greater changes in GH translation. RC activity was higher in the stiff shoulder group, and remained higher post-intervention despite gains in GH translation, suggesting a mechanical rather than neurophysiologic effect. There was no meaningful difference in PPT between modes of mobilization.
LEVEL OF EVIDENCE
Therapy, Randomized Controlled Laboratory Study, Level 1b.",2020,"Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01).","['stiff and healthy shoulders', 'patients with shoulder pathologies', 'Eighty-eight participants, (44 control, 44 stiff shoulders']","['Posterior glide glenohumeral (GH) mobilizations', 'sustained or oscillatory mobilizations', 'oscillatory and sustained posterior GH mobilizations']","['glenohumeral translation, electromyographic activity, and pressure-pain thresholds', 'GH translation', 'RC activity', 'PPT, GH translation via ultrasound imaging, and RC activity assessed via electromyography', 'PPT', 'total RC activity', 'mobility, rotator cuff (RC) activity, and pain processing', 'translation, RC activity, and pressure pain threshold (PPT']","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0241042', 'cui_str': 'Shoulder stiff'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",88.0,0.18114,"Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01).","[{'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Swanson', 'Affiliation': 'University of Hartford, West Hartford, CT, USA; University of New England, Portland, ME, USA. Electronic address: bswanson@Hartford.edu.'}, {'ForeName': 'J Adrienne', 'Initials': 'JA', 'LastName': 'McAuley', 'Affiliation': 'University of New England, Portland, ME, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lawrence', 'Affiliation': 'University of New England, Portland, ME, USA.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102243']
2626,32824994,Exploring Perceptions of Internet-Delivered Cognitive Behaviour Therapy among Public Safety Personnel: Informing Dissemination Efforts.,"Background Public safety personnel (PSP) experience high rates of mental health disorders but have limited access to treatment. To improve treatment access, there is a growing interest in offering internet-delivered cognitive behaviour therapy (ICBT) to PSP. As attitudes towards ICBT can both impact and inform ICBT implementation efforts, this study examines perceptions of ICBT among PSP who viewed a poster (a commonly used method of advertising ICBT) or a poster supplemented with a story of a PSP who benefitted from ICBT. Methods Participants ( N = 132) from various PSP sectors were randomly assigned to view a poster or a poster and a story. Participants then completed an online survey assessing their perceptions of ICBT using both qualitative and quantitative questions. We used a mixed-methods approach to analyze the data. Results No differences in perceptions of ICBT were identified between the conditions. Ratings of credibility, treatment expectancy, anticipated treatment adherence, and acceptability suggested that PSP had positive perceptions of ICBT. Most participants (93%) reported that they would access ICBT if they needed help with mental health concerns. Participants ranked therapist-guided ICBT as their second most preferred treatment, with psychologists ranked first. Female participants found ICBT more credible than male participants. More experienced PSP reported lower acceptability and anticipated adherence to ICBT. Conclusions The findings suggest that many PSP are likely to be receptive to ICBT even when a simple poster is used as a method of informing PSP of this treatment option. Further attention to improving the perceptions of ICBT among certain groups may be warranted.",2020,No differences in perceptions of ICBT were identified between the conditions.,"['Female participants found ICBT more credible than male participants', 'Methods Participants ( N = 132) from various PSP sectors']",['Internet-Delivered Cognitive Behaviour Therapy'],"['Ratings of credibility, treatment expectancy', 'perceptions of ICBT']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038868', 'cui_str': 'Progressive supranuclear palsy'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0686862,No differences in perceptions of ICBT were identified between the conditions.,"[{'ForeName': 'Hugh C', 'Initials': 'HC', 'LastName': 'McCall', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'Angelo P', 'Initials': 'AP', 'LastName': 'Sison', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'Jody L', 'Initials': 'JL', 'LastName': 'Burnett', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'Janine D', 'Initials': 'JD', 'LastName': 'Beahm', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Hadjistavropoulos', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK S4S 0A2, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17176026']
2627,32825020,"Comparative Indoor Pollution from Glo, Iqos, and Juul, Using Traditional Combustion Cigarettes as Benchmark: Evidence from the Randomized SUR-VAPES AIR Trial.","Modified risk products (MRP) such as electronic vaping cigarettes (EVC) and heat-not-burn cigarettes (HNBC) are appealing alternatives to combustion cigarettes. Limited between- and within-device comparative data are available on MRP. We aimed at comparing indoor particulate matter (PM) emissions measured in a randomized trial enforcing standardized smoking sessions, testing different devices and flavors of MRP, using traditional combustion cigarettes (TCC) as benchmark. Overall, MRP yielded significantly lower levels of indoor PM in comparison to TCC (with median PM levels during smoking for MRP < 100 μg/m 3 , and for TCC > 1000 μg/m 3 ). Despite this, significant differences among MRP were found, with Iqos appearing associated with a significantly lower burden of emissions for all the monitored fractions of PM, including total PM (all p < 0.05). Precisely, during use, PM ≤1 µm (PM 1 ) emissions were 28 (16; 28) μg/m 3 for Glo, 25 (15; 57) μg/m 3 for Iqos, and 73 (15; 559) μg/m 3 for Juul ( p < 0.001 for Glo vs. Iqos, p < 0.001 for Glo vs. Juul, and p = 0.045 for Iqos vs. Juul). Exploratory within-MRP analyses suggested significant differences between flavors, favoring, for instance, Ultramarine for Glo, Bronze for Iqos, and Mango for Juul, even if results varied substantially according to individual smoker. In conclusion, leading MRP have significantly less intense and persistent effects on indoor pollution in comparison to TCC. Yet, when focusing solely on MRP, between-product and between-flavor differences appear, with quantitative estimates suggesting lower polluting effects with Iqos. These results, if confirmed externally, could be used to individualize product and flavor choice to minimize the untoward effects of EVC and HNBC on indoor pollution.",2020,"Overall, MRP yielded significantly lower levels of indoor PM in comparison to TCC (with median PM levels during smoking for MRP",[],"['MRP', 'traditional combustion cigarettes (TCC', 'indoor particulate matter (PM) emissions', 'TCC', 'Modified risk products (MRP) such as electronic vaping cigarettes (EVC) and heat-not-burn cigarettes (HNBC']","['burden of emissions', 'total PM']",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0077072', 'cui_str': 'triclocarban'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0455956', 'cui_str': 'Cigarette burn'}]","[{'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0436517,"Overall, MRP yielded significantly lower levels of indoor PM in comparison to TCC (with median PM levels during smoking for MRP","[{'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Peruzzi', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Cavarretta', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Frati', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Carnevale', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Miraldi', 'Affiliation': 'Department of Clinical, Internal Medicine, Anesthesiology and Cardiovascular Sciences, Sapienza University of Rome, Viale Del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Biondi-Zoccai', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Sciarretta', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Versaci', 'Affiliation': 'UOC UTIC Emodinamica e Cardiologia, Ospedale Santa Maria Goretti, Via Antonio Canova, 04100 Latina, Italy.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Cammalleri', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Avino', 'Affiliation': 'Department of Agricultural, Environmental and Food Sciences (DiAAA), University of Molise, via De Sanctis, 86100 Campobasso, Italy.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Protano', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Vitali', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17176029']
2628,32828570,The Effect of a Personalized Newsletter to Physical Therapists on Patient Recruitment: A Cluster Randomized Trial in Primary Physiotherapy Care.,"OBJECTIVE
To assess the effect of a personalized newsletter compared with a standard newsletter on patient recruitment in physiotherapy research.
METHODS
We performed a cluster-randomized trial including 120 physiotherapists who recruited patients for a prospective cohort and were randomly assigned to either receiving personalized feedback in a newsletter (intervention group) or a standard newsletter (control group). We calculated the difference in the number of patients included in the study corrected for inclusion time between both groups.
RESULTS
The physiotherapists in the control group (n = 59) included 110 patients (35.4% of the total number of patients included) compared with an inclusion of 200 patients (64.6% of the total number of patients included) by the physiotherapists in the intervention group (n = 61), a difference of 90 patients in favor of the intervention group. However, when corrected for inclusion time and a cluster effect, we found no statistically significant difference between both groups. In addition, therapists who did not include a single patient (inactive therapists) were evenly divided between the 2 groups (n = 29 [49%] in the control group; n = 30 [49%] in the intervention group).
CONCLUSIONS
A personalized newsletter does not significantly increase the number of recruited patients by physiotherapists. However, therapists receiving personalized feedback recruited nearly double the number of patients compared with the ones receiving standard feedback.",2020,"However, when corrected for inclusion time and a cluster effect, we found no statistically significant difference between both groups.","['Patient Recruitment', '120 physiotherapists who recruited patients for a prospective cohort']","['personalized feedback in a newsletter (intervention group) or a standard newsletter (control group', 'Personalized Newsletter to Physical Therapists']",[],"[{'cui': 'C0242800', 'cui_str': 'Patient Recruitment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]",[],120.0,0.0950398,"However, when corrected for inclusion time and a cluster effect, we found no statistically significant difference between both groups.","[{'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Thoomes-de Graaf', 'Affiliation': 'Department of General Practice, Erasmus University Medical Center Rotterdam, Rotterdam, Netherlands; Research Group Diagnostics, Avans University of Applied Science, Breda, Netherlands. Electronic address: marloesthoomes@me.com.'}, {'ForeName': 'Rienke E', 'Initials': 'RE', 'LastName': 'Wiersma', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Yasmaine', 'Initials': 'Y', 'LastName': 'Karel', 'Affiliation': 'Department of General Practice, Erasmus University Medical Center Rotterdam, Rotterdam, Netherlands; Research Group Diagnostics, Avans University of Applied Science, Breda, Netherlands.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Duijn', 'Affiliation': 'Research Group Diagnostics, Avans University of Applied Science, Breda, Netherlands.'}, {'ForeName': 'Bea', 'Initials': 'B', 'LastName': 'Spek', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Rizopoulos', 'Affiliation': 'Department of Biostatistics, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Gwendolijne G M', 'Initials': 'GGM', 'LastName': 'Scholten-Peeters', 'Affiliation': 'Department of Human Movement Sciences, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Arianne P', 'Initials': 'AP', 'LastName': 'Verhagen', 'Affiliation': 'Department of General Practice, Erasmus University Medical Center Rotterdam, Rotterdam, Netherlands; Department of Physiotherapy, Graduate School of Health University of Technology Sydney, Sydney, Australia.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.12.002']
2629,32828927,"Virtual training leads to physical, cognitive and neural benefits in healthy adults.","Physical activity, such as high-intensity intermittent aerobic exercise (HIE), can improve executive functions. Although performing strength or aerobic training might be problematic or not feasible for someone. An experimental situation where there is no actual movement, but the body shows physiological reactions, is during the illusion through immersive virtual reality (IVR). We aimed to demonstrate whether a virtual HIE-based intervention (vHIE) performed exclusively by the own virtual body has physical, cognitive, and neural benefits on the real body. 45 healthy young adults (cross-over design) experienced HIE training in IVR (i.e., the virtual body performed eight sets of 30 s of running followed by 30 s of slow walking, while the subject is completely still) in two random-ordered conditions (administered in two sessions one week apart): the virtual body is displayed in first-person perspective (1PP) or third-person perspective (3PP). During the vHIE, we recorded the heart rate and subjective questionnaires to confirm the effectiveness of the illusion; before and after vHIE, we measured cortical hemodynamic changes in the participants' left dorsolateral prefrontal cortex (lDLPFC) using the fNIRS device during the Stroop task to test our main hypothesis. Preliminary, we confirmed that the illusion was effective: during the vHIE in 1PP, subjects' heart rate increased coherently with the virtual movements, and they reported subjective feelings of ownership and agency. Primarily, subjects were faster in executing the Stroop task after the vHIE in 1PP; also, the lDLPFC activity increased coherently. Clinically, these results might be exploited to train cognition and body simultaneously. Theoretically, we proved that the sense of body ownership and agency can affect other parameters, even in the absence of actual movements.",2020,"Primarily, subjects were faster in executing the Stroop task after the vHIE in 1PP; also, the lDLPFC activity increased coherently.","['healthy adults', '45 healthy young adults']","['strength or aerobic training', 'virtual HIE-based intervention (vHIE', 'Virtual training', 'Physical activity, such as high-intensity intermittent aerobic exercise (HIE', 'virtual body is displayed in first-person perspective (1PP) or third-person perspective (3PP', 'HIE training']","['heart rate and subjective questionnaires', 'lDLPFC activity', 'heart rate']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",45.0,0.0142803,"Primarily, subjects were faster in executing the Stroop task after the vHIE in 1PP; also, the lDLPFC activity increased coherently.","[{'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Burin', 'Affiliation': 'Smart Aging International Research Center (SAIRC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan; Institute of Development, Aging and Cancer (IDAC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan. Electronic address: burin.dalila.c3@tohoku.ac.jp.'}, {'ForeName': 'Yingxu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Smart Aging International Research Center (SAIRC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan.'}, {'ForeName': 'Noriki', 'Initials': 'N', 'LastName': 'Yamaya', 'Affiliation': 'Institute of Development, Aging and Cancer (IDAC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Kawashima', 'Affiliation': 'Smart Aging International Research Center (SAIRC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan; Institute of Development, Aging and Cancer (IDAC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117297']
2630,32829942,"Plantar Myofascial Mobilization: Plantar Area, Functional Mobility, and Balance in Elderly Women: A Randomized Clinical Trial.","OBJECTIVE
The purpose of this study was to evaluate the effects of plantar myofascial mobilization (PMM) on the plantar area, balance, and functional mobility of elderly women.
METHODS
In this randomized, single-blind, placebo-controlled clinical trial, elderly women with maintained independent orthostatism were recruited from the community and randomly separated into a PMM group (MG = 15), a placebo group (PG = 13), or a control group (control group = 14). Vigorous PMM and soft PMM were performed in the MG and PG, respectively, for 5 days with a rest day between each. The measures of plantar area, single leg stance test with open eye and closed eye, and timed up-and-go test were performed pre-PMM, immediately post-PMM, and on the last day of the protocol. The control group only underwent evaluation before and on the last day of the protocol. The sample size was calculated, and, for quantitative variables, a mixed analysis of variance was used for repeated measurements (split plot), followed by the Bonferroni post hoc test. The results were analyzed in 2 ways: 3 groups at 2 moments (pre, last day), and 2 groups at 3 moments (pre, post, last day).
RESULTS
Forty-two elderly women with mean age of 69.03 ± 3.32 years were included in the study. The vigorous MMP showed a statistically significant increase in the plantar area of the right foot (3 groups: P = .49) and single leg stance test with open eye time (2 groups: P = .002; 3 groups: P = .001), and a decrease in the timed up-and-go time (2 groups: P = .04; 3 groups: P = .0001).
CONCLUSION
The vigorous PMM showed increases of the plantar area and promoted beneficial effects on functional mobility and body balance.",2020,"The vigorous MMP showed a statistically significant increase in the plantar area of the right foot (3 groups: P = .49) and single leg stance test with open eye time (2 groups: P = .002; 3 groups: P = .001), and a decrease in the timed up-and-go time (2 groups: P = .04; 3 groups: P = .0001).
","['Forty-two elderly women with mean age of 69.03 ± 3.32 years were included in the study', 'elderly women with maintained independent orthostatism', 'Elderly Women', 'elderly women']","['plantar myofascial mobilization (PMM', 'PMM', 'placebo']","['timed up-and-go time', 'functional mobility and body balance', 'single leg stance test with open eye time', 'plantar area of the right foot', 'plantar area, single leg stance test with open eye and closed eye, and timed up-and-go test', 'plantar area, balance, and functional mobility']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517689', 'cui_str': '3.32'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1299583', 'cui_str': 'Independent'}]","[{'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0230460', 'cui_str': 'Structure of right foot'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]",42.0,0.0348885,"The vigorous MMP showed a statistically significant increase in the plantar area of the right foot (3 groups: P = .49) and single leg stance test with open eye time (2 groups: P = .002; 3 groups: P = .001), and a decrease in the timed up-and-go time (2 groups: P = .04; 3 groups: P = .0001).
","[{'ForeName': 'Ana E Z', 'Initials': 'AEZ', 'LastName': 'Stroppa-Marques', 'Affiliation': 'Department of Physical Therapy and Occupational Therapy, São Paulo State University, Marília, São Paulo, Brazil. Electronic address: anastropa@hotmail.com.'}, {'ForeName': 'João S Melo', 'Initials': 'JSM', 'LastName': 'Neto', 'Affiliation': 'Faculty of Physical Therapy and Occupational Therapy, Health Science Institute, Federal University of Pará, Belém, Pará, Brazil.'}, {'ForeName': 'Cristiane R', 'Initials': 'CR', 'LastName': 'Pedroni', 'Affiliation': 'Department of Physical Therapy and Occupational Therapy, São Paulo State University, Marília, São Paulo, Brazil.'}, {'ForeName': 'Beatriz M', 'Initials': 'BM', 'LastName': 'Tozim', 'Affiliation': 'Department of Physical Therapy and Occupational Therapy, São Paulo State University, Marília, São Paulo, Brazil.'}, {'ForeName': 'Eduardo F B', 'Initials': 'EFB', 'LastName': 'Chagas', 'Affiliation': 'Department of Physical Education, University of Marilia, Marília, São Paulo, Brazil.'}, {'ForeName': 'Flávia R F', 'Initials': 'FRF', 'LastName': 'Navega', 'Affiliation': 'Department of Physical Therapy and Occupational Therapy, São Paulo State University, Marília, São Paulo, Brazil.'}, {'ForeName': 'Marcelo T', 'Initials': 'MT', 'LastName': 'Navega', 'Affiliation': 'Department of Physical Therapy and Occupational Therapy, São Paulo State University, Marília, São Paulo, Brazil.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.11.007']
2631,32830913,Paclitaxel exposure: Long-term safety and effectiveness of a drug-coated balloon for claudication in pooled randomized trials.,"BACKGROUND
Paclitaxel drug-coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow-up have raised uncertainty regarding long-term mortality.
OBJECTIVES
To evaluate the effect of paclitaxel exposure on the long-term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials.
METHODS
The IN.PACT randomized trials (SFA, N = 331 and Japan, N = 100) each compared the DCB with standard percutaneous transluminal angioplasty (PTA) for claudication, and consented patients for 5 and 3 years, respectively. To address long-term safety, sites were requested to obtain vital status follow-up. In the pooled, updated data set, we examined the association between randomized treatment and mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD-TLR). Multivariable Cox regression with adjustment for baseline characteristics was used to evaluate the dose effect. Causes of death were adjudicated by a blinded clinical events committee that included oncologists with paclitaxel expertise.
RESULTS
The rate of long-term vital status ascertainment increased from 81% to 97% for DCB and from 85% to 97% for PTA in the IN.PACT SFA trial. The cumulative incidence of mortality was 14.7% DCB versus 12.0% PTA at 5 years, HR 1.39, log-rank p = .286. Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p = .381), but was an independent predictor of reduced risk of CD-TLR (HR 0.79; p < .001). Causes of death did not differ by treatment arm.
CONCLUSIONS
In pooled randomized trial data with updated vital status ascertainment, paclitaxel was associated with improved efficacy but was not associated with increased mortality.",2020,"Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p = .381), but was an independent predictor of reduced risk of CD-TLR (HR 0.79; p < .001).",[],"['paclitaxel', 'Paclitaxel', 'DCB with standard percutaneous transluminal angioplasty (PTA', 'Paclitaxel drug-coated balloons (DCB', 'drug-coated balloon']","['Causes of death', 'rate of long-term vital status ascertainment', 'cumulative incidence of mortality', 'reduced risk of CD-TLR', 'mortality', 'mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD-TLR']",[],"[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}]","[{'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}]",,0.412089,"Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p = .381), but was an independent predictor of reduced risk of CD-TLR (HR 0.79; p < .001).","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Schneider', 'Affiliation': 'Division of Vascular and Endovascular Surgery, University of California at San Francisco, San Francisco, California.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brodmann', 'Affiliation': 'Division of Angiology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mauri', 'Affiliation': 'Medtronic Inc., Minneapolis, Minnesota.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Laird', 'Affiliation': 'Adventist Heart and Vascular Institute, St. Helena, California.'}, {'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Soga', 'Affiliation': 'Kokura Memorial Hospital, Fukuoka, Japan.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Micari', 'Affiliation': 'Humanitas Gavazzeni Hospital, Bergamo, Italy.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Ansel', 'Affiliation': 'Ohio Health, Riverside Methodist Hospital, Columbus, Ohio.'}, {'ForeName': 'Mehdi H', 'Initials': 'MH', 'LastName': 'Shishehbor', 'Affiliation': 'Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Krishnan', 'Affiliation': 'The Mount Sinai Hospital, New York.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Baim Institute for Clinical Research, Boston, Massachusetts.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ouriel', 'Affiliation': 'Syntactx, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': 'Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29152']
2632,32839468,Hydrocortisone decreases metacognitive efficiency independent of perceived stress.,"It is well established that acute stress produces negative effects on high level cognitive functions. However, these effects could be due to the physiological components of the stress response (among which cortisol secretion is prominent), to its psychological concomitants (the thoughts generated by the stressor) or to any combination of those. Our study shows for the first time that the typical cortisol response to stress is sufficient to impair metacognition, that is the ability to monitor one's own performance in a task. In a pharmacological protocol, we administered either 20 mg hydrocortisone or placebo to 46 male participants, and measured their subjective perception of stress, their performance in a perceptual task, and their metacognitive ability. We found that hydrocortisone selectively impaired metacognitive ability, without affecting task performance or creating a subjective state of stress. In other words, the single physiological response of stress produces a net effect on metacognition. These results inform our basic understanding of the physiological bases of metacognition. They are also relevant for applied or clinical research about situations involving stress, anxiety, depression, or simply cortisol use.",2020,"We found that hydrocortisone selectively impaired metacognitive ability, without affecting task performance or creating a subjective state of stress.",['46 male participants'],"['hydrocortisone', 'hydrocortisone or placebo', 'Hydrocortisone']","['metacognitive efficiency', 'metacognitive ability']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",46.0,0.0210605,"We found that hydrocortisone selectively impaired metacognitive ability, without affecting task performance or creating a subjective state of stress.","[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Reyes', 'Affiliation': 'Facultad de Psicología, Universidad del Desarrollo (UDD), Av. La Plaza 700, Las Condes, Santiago, Chile.'}, {'ForeName': 'Anastassia', 'Initials': 'A', 'LastName': 'Vivanco-Carlevari', 'Affiliation': 'Facultad de Psicología, Universidad del Desarrollo (UDD), Av. La Plaza 700, Las Condes, Santiago, Chile.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Medina', 'Affiliation': 'Facultad de Psicología, Universidad del Desarrollo (UDD), Av. La Plaza 700, Las Condes, Santiago, Chile.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Manosalva', 'Affiliation': 'Institute of Pharmacy, Faculty of Sciences, Universidad Austral de Chile (UACh), Valdivia, Chile.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'de Gardelle', 'Affiliation': 'Paris School of Economics and CNRS, Paris, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Sackur', 'Affiliation': ""Laboratoire de Sciences Cognitives Et Psycholinguistique (EHESS/CNRS/ENS), PSL Research University, École Normale Supérieure, 29 rue d'Ulm, 75005, Paris, France. jerome.sackur@gmail.com.""}, {'ForeName': 'Jaime R', 'Initials': 'JR', 'LastName': 'Silva', 'Affiliation': 'Facultad de Psicología, Universidad del Desarrollo (UDD), Av. La Plaza 700, Las Condes, Santiago, Chile. jaimesilva@udd.cl.'}]",Scientific reports,['10.1038/s41598-020-71061-3']
2633,32833791,Prism adaptation treatment for upper-limb complex regional pain syndrome: a double-blind randomized controlled trial.,"Initial evidence suggested that people with complex regional pain syndrome (CRPS) have reduced attention to the affected side of their body and the surrounding space, which might be related to pain and other clinical symptoms. Three previous unblinded, uncontrolled studies showed pain relief after treatment with prism adaptation, an intervention that has been used to counter lateralised attention bias in brain-lesioned patients. To provide a robust test of its effectiveness for CRPS, we conducted a double-blind randomized controlled trial of prism adaptation for unilateral upper-limb CRPS-I. Forty-nine eligible adults with CRPS were randomized to undergo 2 weeks of twice-daily home-based prism adaptation treatment (n = 23) or sham treatment (n = 26). Outcomes were assessed in person 4 weeks before and immediately before treatment, and immediately after and 4 weeks after treatment. Long-term postal follow-ups were conducted 3 and 6 months after treatment. We examined the effects of prism adaptation vs sham treatment on current pain intensity and the CRPS symptom severity score (primary outcomes), as well as sensory, motor, and autonomic functions, self-reported psychological functioning, and experimentally tested neuropsychological functions (secondary outcomes). We found no evidence that primary or secondary outcomes differed between the prism adaptation and sham treatment groups when tested at either time point after treatment. Overall, CRPS severity significantly decreased over time for both groups, but we found no benefits of prism adaptation beyond sham treatment. Our findings do not support the efficacy of prism adaptation treatment for relieving upper-limb CRPS-I. This trial was prospectively registered (ISRCTN46828292).",2020,"Overall, CRPS severity significantly decreased over time for both groups, but we found no benefits of prism adaptation beyond sham treatment.","['upper-limb Complex Regional Pain Syndrome', 'unilateral upper-limb CRPS-I. Forty-nine eligible adults with CRPS', 'people with Complex Regional Pain Syndrome (CRPS']","['prism adaptation versus sham treatment', 'prism adaptation', 'Prism adaptation treatment', 'prism adaptation treatment', 'twice-daily home-based prism adaptation treatment']","['sensory, motor, and autonomic functions, self-reported psychological functioning, and experimentally tested neuropsychological functions', 'Overall, CRPS severity', 'current pain intensity and CRPS symptom severity score', 'pain relief']","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",49.0,0.411187,"Overall, CRPS severity significantly decreased over time for both groups, but we found no benefits of prism adaptation beyond sham treatment.","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Halicka', 'Affiliation': 'Centre for Pain Research, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Axel D', 'Initials': 'AD', 'LastName': 'Vittersø', 'Affiliation': 'Centre for Pain Research, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'McCullough', 'Affiliation': 'Department of Translational Medicine, Pain Research Institute, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goebel', 'Affiliation': 'Department of Translational Medicine, Pain Research Institute, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Heelas', 'Affiliation': 'Optimise Pain Rehabilitation Unit, Oxford University Hospitals NHS Trust, Oxford, United Kingdom.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Proulx', 'Affiliation': 'Department of Psychology, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Bultitude', 'Affiliation': 'Centre for Pain Research, University of Bath, Bath, United Kingdom.'}]",Pain,['10.1097/j.pain.0000000000002053']
2634,32835895,A twelve-month follow-up of an information communication technology delivered intervention for children with autism spectrum disorder living in regional Australia.,"This study investigated the long-term follow-up of an information communication techonology based intervention, the Therapeutic Outcomes By You application, for children with autism spectrum disorder living in regional Australia. Fifteen participants who completed a three-month randomised controlled trial of the Therapeutic Outcomes By You were assessed at least 12 months post-intervention to determine the maintenance or continued improvement of their language and social communication skills. Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.",2020,"Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.","['Fifteen participants who completed a three-month randomised controlled trial of the Therapeutic Outcomes', 'children with autism spectrum disorder living in regional Australia']",[],"['receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]",[],"[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]",15.0,0.0425543,"Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.","[{'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Parsons', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia. Electronic address: dave.parsons@curtin.edu.au.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Vaz', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia.'}, {'ForeName': 'Hoe', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Robinson', 'Affiliation': 'Kids are Kids!, Australia.'}, {'ForeName': 'Reinie', 'Initials': 'R', 'LastName': 'Cordier', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia; Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle upon Tyne, United Kingdom.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103743']
2635,32381738,Decisional autonomy undermines advisees' judgments of experts in medicine and in life.,"Over the past several decades, the United States medical system has increasingly prioritized patient autonomy. Physicians routinely encourage patients to come to their own decisions about their medical care rather than providing patients with clearer yet more paternalistic advice. Although political theorists, bioethicists, and philosophers generally see this as a positive trend, the present research examines the important question of how patients and advisees in general react to full decisional autonomy when making difficult decisions under uncertainty. Across six experiments ( N = 3,867), we find that advisers who give advisees decisional autonomy rather than offering paternalistic advice are judged to be less competent and less helpful. As a result, advisees are less likely to return to and recommend these advisers and pay them lower wages. Importantly, we also demonstrate that advisers do not anticipate these effects. We document these results both inside and outside the medical domain, suggesting that the preference for paternalism is not unique to medicine but rather is a feature of situations in which there are adviser-advisee asymmetries in expertise. We find that the preference for paternalism holds when advice is solicited or unsolicited, when both paternalism and autonomy are accompanied by expert guidance, and it persists both before and after the outcomes of paternalistic advice are realized. Lastly, we see that the preference for paternalism only occurs when decision makers perceive their decision to be difficult. These results challenge the benefits of recently adopted practices in medical decision making that prioritize full decisional autonomy.",2020,"Across six experiments ( N = 3,867), we find that advisers who give advisees decisional autonomy rather than offering paternalistic advice are judged to be less competent and less helpful.","[""Decisional autonomy undermines advisees' judgments of experts in medicine and in life""]",[],[],"[{'cui': 'C1822301', 'cui_str': 'Wound tissue undermining'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",[],[],,0.0196684,"Across six experiments ( N = 3,867), we find that advisers who give advisees decisional autonomy rather than offering paternalistic advice are judged to be less competent and less helpful.","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Kassirer', 'Affiliation': 'Kellogg School of Management, Northwestern University, Evanston, IL 60208; samantha.kassirer@kellogg.northwestern.edu.'}, {'ForeName': 'Emma E', 'Initials': 'EE', 'LastName': 'Levine', 'Affiliation': 'Booth School of Business, University of Chicago, Chicago, IL, 60637.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Gaertig', 'Affiliation': 'Booth School of Business, University of Chicago, Chicago, IL, 60637.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1910572117']
2636,32841825,A randomized study of CrossFit Kids for fostering fitness and academic outcomes in middle school students.,"Within the context of school-based physical education (PE), a strength and conditioning program called CrossFit Kids (CFK) has emerged as a potential intervention for positively impacting students. The purpose of this study was to evaluate through a randomized-controlled trial how academic and health-related fitness outcomes differed for middle school students (age = 12.73; 55.3 % male) who participated in a school-based CFK program (n=72) as compared to a group of students who participated in PE class (n=72). Questionnaire data were collected twice across the 9-month academic year and combined with FitnessGram and grade data. Students in both the intervention and comparison groups increased in health-related fitness outcomes (all p values < .017), and there was a significant treatment group by time interaction on school-reported grades [F(1, 124) = 7.270, p = .008, η_P^2 = .055]. Significant gender by time interaction effects were found for the relationship between CFK or PE participation and health-related fitness outcomes, but there were no significant interaction effects by gender on academic outcomes. Because developmental outcomes are conditional and result from the coaction of many factors, the findings suggest that some elements of CFK might be beneficial to build skills yet disadvantageous to academic outcomes.",2020,"Students in both the intervention and comparison groups increased in health-related fitness outcomes (all p values < .017), and there was a significant treatment group by time interaction on school-reported grades [F(1, 124) = 7.270, p = .008, η_P^2 = .055].","['middle school students (age = 12.73; 55.3 % male) who participated in a school-based CFK program (n=72) as compared to a group of students who participated in PE class (n=72', 'middle school students']","['school-based physical education (PE), a strength and conditioning program called CrossFit Kids (CFK', 'CrossFit Kids']","['health-related fitness outcomes', 'Questionnaire data', 'fostering fitness and academic outcomes']","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}]",,0.0283754,"Students in both the intervention and comparison groups increased in health-related fitness outcomes (all p values < .017), and there was a significant treatment group by time interaction on school-reported grades [F(1, 124) = 7.270, p = .008, η_P^2 = .055].","[{'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Garst', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, Clemson University, USA. Electronic address: bgarst@clemson.edu.'}, {'ForeName': 'Edmond P', 'Initials': 'EP', 'LastName': 'Bowers', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, Clemson University, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Stephens', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, Clemson University, USA.'}]",Evaluation and program planning,['10.1016/j.evalprogplan.2020.101856']
2637,32842644,Effects of Pyramid Resistance-Training System with Different Repetition Zones on Cardiovascular Risk Factors in Older Women: A Randomized Controlled Trial.,"This study analyzed the effects of the pyramidal resistance training (RT) system with two repetition zones on cardiovascular risk factors in older women (≥60 years old). Fifty-nine older women were randomly assigned in three groups: non-exercise control (CON, n = 19), narrow-pyramid system (NPR, n = 20), and wide-pyramid system (WPR, n = 20). Training was performed for eight weeks (eight exercises for the whole-body, 3x/week) in which NPR and WPR performed three sets of 12/10/8 and 15/10/5 repetitions, respectively. Regional body fat was estimated by dual-energy X-ray absorptiometry, and blood parameters related to glycemic, lipid, and inflammatory profiles were assessed. After the training period, although no difference was observed for the magnitude of the changes between NPR and WPR, significant group by time interactions indicated benefits with RT compared to CON for reducing body fat (mainly android body fat; -7%) and improving glucose, HDL-C, LDL-C and C-reactive protein ( p < 0.05). Composite z-score of cardiovascular risk, created by the average of the intervention effects on the outcomes, indicate similar responses between NPR and WPR, differing from CON ( p < 0.001). Results indicate that both the repetition zones of the pyramidal RT reduced similarly the cardiovascular risk in older women.",2020,"After the training period, although no difference was observed for the magnitude of the changes between NPR and WPR, significant group by time interactions indicated benefits with RT compared to CON for reducing body fat (mainly android body fat; -7%) and improving glucose, HDL-C, LDL-C and C-reactive protein ( p < 0.05).","['older women', 'Older Women', 'Fifty-nine older women', 'older women (≥60 years old']","['pyramidal resistance training (RT) system with two repetition zones', 'CON', 'non-exercise control (CON, n = 19), narrow-pyramid system (NPR, n = 20), and wide-pyramid system', 'Pyramid Resistance-Training System with Different Repetition Zones']","['cardiovascular risk factors', 'Cardiovascular Risk Factors', 'body fat', 'Composite z-score of cardiovascular risk', 'improving glucose, HDL-C, LDL-C and C-reactive protein', 'Regional body fat', 'cardiovascular risk']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C0332464', 'cui_str': 'Widening'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205147', 'cui_str': 'Regional'}]",59.0,0.0213912,"After the training period, although no difference was observed for the magnitude of the changes between NPR and WPR, significant group by time interactions indicated benefits with RT compared to CON for reducing body fat (mainly android body fat; -7%) and improving glucose, HDL-C, LDL-C and C-reactive protein ( p < 0.05).","[{'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Dos Santos', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Alex S', 'Initials': 'AS', 'LastName': 'Ribeiro', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Crisieli M', 'Initials': 'CM', 'LastName': 'Tomeleri', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Hellen C G', 'Initials': 'HCG', 'LastName': 'Nabuco', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Matheus A', 'Initials': 'MA', 'LastName': 'Nascimento', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Sugihara Junior', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Rodrigo R', 'Initials': 'RR', 'LastName': 'Fernandes', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Campa', 'Affiliation': 'Department for Life Quality Studies, University of Bologna, 47921 Rimini, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Toselli', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Venturini', 'Affiliation': 'Clinical Analyses Laboratory, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Décio S', 'Initials': 'DS', 'LastName': 'Barbosa', 'Affiliation': 'Clinical Analyses Laboratory, Londrina State University, 86057-970 Londrina, PR, Brazil.'}, {'ForeName': 'Luís B', 'Initials': 'LB', 'LastName': 'Sardinha', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, 1499-002 Lisboa, Portugal.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sports Center, Londrina State University, 86057-970 Londrina, PR, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17176115']
2638,32844586,Intake of Fermented Dairy Products Induces a Less Pro-Inflammatory Postprandial Peripheral Blood Mononuclear Cell Gene Expression Response than Non-Fermented Dairy Products: A Randomized Controlled Cross-Over Trial.,"SCOPE
It is aimed to investigate how intake of high-fat meals composed of different dairy products with a similar fat content affects postprandial peripheral blood mononuclear cell (PBMC) expression of inflammation-related genes, as well as circulating inflammatory markers and metabolites.
METHODS AND RESULTS
Healthy subjects (n = 47) consume four different high-fat meals composed of either butter, cheese, whipped cream, or sour cream in a randomized controlled cross-over study. Fasting and postprandial PBMC gene expression, plasma metabolites, and circulating inflammatory markers are measured. Using a linear mixed model, it is found that expression of genes related to lymphocyte activation, cytokine signaling, chemokine signaling, and cell adhesion is differentially altered between the four meals. In general, intake of the fermented products cheese and sour cream reduces, while intake of the non-fermented products butter and whipped cream increases, expression of these genes. Plasma amino acid concentrations increase after intake of cheese compared to the other meals, and the amino acid changes correlate with several of the differentially altered genes.
CONCLUSION
Intake of fermented dairy products, especially cheese, induces a less inflammatory postprandial PBMC gene expression response than non-fermented dairy products. These findings may partly explain inconsistent findings in studies on health effects of dairy products.",2020,"In general, intake of the fermented products cheese and sour cream reduced, while intake of the non-fermented products butter and whipped cream increased, expression of these genes.",['Healthy subjects (n = 47'],"['consumed four different high-fat meals composed of either butter, cheese, whipped cream or sour cream', 'Fermented Dairy Products']","['inflammatory postprandial PBMC gene expression response', 'Plasma amino acid concentrations', 'Fasting and postprandial PBMC gene expression, plasma metabolites and circulating inflammatory markers', 'lymphocyte activation, cytokine signaling, chemokine signaling, and cell adhesion']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0452750', 'cui_str': 'Whipping cream'}, {'cui': 'C0452749', 'cui_str': 'Soured cream'}, {'cui': 'C0010947', 'cui_str': 'Dairy foods'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024262', 'cui_str': 'Blast Transformation'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0007577', 'cui_str': 'Cell Adhesion'}]",47.0,0.0281853,"In general, intake of the fermented products cheese and sour cream reduced, while intake of the non-fermented products butter and whipped cream increased, expression of these genes.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Rundblad', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Boks 1072 Blindern, Oslo, 0316, Norway.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Holven', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Boks 1072 Blindern, Oslo, 0316, Norway.'}, {'ForeName': 'Linn K L', 'Initials': 'LKL', 'LastName': 'Øyri', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Boks 1072 Blindern, Oslo, 0316, Norway.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Hansson', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health Sciences, UiT The Arctic University of Norway, Postboks 6050 Langnes, Tromsø, 9037, Norway.'}, {'ForeName': 'Ingvild H', 'Initials': 'IH', 'LastName': 'Ivan', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Boks 1072 Blindern, Oslo, 0316, Norway.'}, {'ForeName': 'Gyrd O', 'Initials': 'GO', 'LastName': 'Gjevestad', 'Affiliation': 'Marketing Department, TINE SA, Postboks 7, Oslo, 0901, Norway.'}, {'ForeName': 'Magne', 'Initials': 'M', 'LastName': 'Thoresen', 'Affiliation': 'Oslo Center for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Boks 1072 Blindern, Oslo, 0316, Norway.'}, {'ForeName': 'Stine M', 'Initials': 'SM', 'LastName': 'Ulven', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Boks 1072 Blindern, Oslo, 0316, Norway.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000319']
2639,32852475,Reply: Outcomes of DIEP Flap and Fluorescent Angiography: A Randomized Controlled Clinical Trial.,,2020,,[],['DIEP Flap and Fluorescent Angiography'],[],[],"[{'cui': 'C0082274', 'cui_str': 'Diclofenac epolamine'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0086305', 'cui_str': 'Angiography, Fluorescence'}]",[],,0.215261,,"[{'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Varela', 'Affiliation': 'Department of Plastic Surgery, Hospital Quiron Madrid-Pozuelo Fundación FIBHULP-IdiPaz, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Landin', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007298']
2640,32852479,Outcomes of DIEP Flap and Fluorescent Angiography: A Randomized Controlled Clinical Trial.,,2020,,[],['DIEP Flap and Fluorescent Angiography'],[],[],"[{'cui': 'C0082274', 'cui_str': 'Diclofenac epolamine'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0086305', 'cui_str': 'Angiography, Fluorescence'}]",[],,0.188824,,"[{'ForeName': 'Ziying', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Aesthetic and Reconstructive Breast Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Minqiang', 'Initials': 'M', 'LastName': 'Xin', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007297']
2641,32853900,Effects of a mindfulness-based childbirth and parenting program on maternal-fetal attachment: A randomized controlled trial among Iranian pregnant women.,"BACKGROUND AND PURPOSE
Although mindfulness-based childbirth and parenting is suggested to promote maternal-fetal attachment, no study has yet addressed its potential effects. This study aimed to determine the effects of a mindfulness-based childbirth and parenting program on maternal-fetal attachment among Iranian pregnant women.
MATERIALS AND METHODS
This study was conducted on pregnant women, who were divided into two groups to either receive routine care plus mindfulness training for childbirth and parenting (i.e., eight 2-h group sessions once a week and one 3-h session of silent meditation) or receive routine care alone. Maternal-fetal attachment was evaluated by the Cranley's Maternal-Fetal Attachment Scale.
RESULTS
After the intervention, the total score of maternal-fetal attachment was significantly higher in the experimental group (P < 0.001; effect size = 0.640). In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
CONCLUSION
The implemented program in this study was potentially effective in promoting maternal-fetal attachment.",2020,"In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
","['pregnant women', 'Iranian pregnant women']","['routine care plus mindfulness training', 'routine care alone', 'mindfulness-based childbirth and parenting program']","['dimension of ""attributing characteristics to the fetus"" improved', 'total score of maternal-fetal attachment', 'dimension of ""differentiation of self from the fetus', 'Maternal-fetal attachment', 'maternal-fetal attachment', ""Cranley's Maternal-Fetal Attachment Scale""]","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0224299,"In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Gheibi', 'Affiliation': 'Student Research Committee, Department of Midwifery, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Zeinab_gheibi@yahoo.com.'}, {'ForeName': 'Zabihollah', 'Initials': 'Z', 'LastName': 'Abbaspour', 'Affiliation': 'Department of Psychology, School of Education and Psychology, Shahid Chamran University of Ahvaz, Ahvaz, Iran. Electronic address: Zabbaspour1356@gmail.com.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Haghighyzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Haghighy-mh@ajums.ac.ir.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Javadifar', 'Affiliation': 'Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Javadifar-n@ajums.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101226']
2642,32854000,Abstinence-reinforcing contingency management improves HIV viral load suppression among HIV-infected people who use drugs: A randomized controlled trial.,"BACKGROUND
HIV-infected people who use drugs (PWUD) have poor HIV outcomes. Few studies tested interventions to improve HIV outcomes among PWUD. Abstinence-reinforcing contingency management (CM) reduces drug use and could also improve HIV outcomes.
METHODS
From 2012-2017, we conducted a randomized controlled trial testing whether a 16-week abstinence-reinforcing CM intervention improved HIV viral load (VL) among HIV-infected adults using opioids or cocaine. In the CM intervention, drug-free urines led to escalating value of vouchers ($2.50-$80/voucher, $1320 total maximum). In intention-to-treat mixed-effects linear and logistic regression analyses, we examined whether the CM intervention improved log 10 VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes).
RESULTS
Thirty-seven participants were randomized to the CM intervention and 36 to control. Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6%). In CM (vs. control) participants, mean reduction in log 10 VL was greater (-0.16 log 10 VL copies/mL per 4-week period; 95% CI: -0.29 to -0.03, p < 0.05). Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10 VL greater than control participants. The CM intervention was not significantly associated with abstinence or adherence.
CONCLUSIONS
This is the first study to demonstrate improvements in HIV VL via an abstinence-reinforcing CM intervention. Because the CM intervention did not significantly affect abstinence or adherence, the mechanism of its effect is unclear. To end the HIV epidemic, innovative strategies must address individuals with poor HIV outcomes. Abstinence-reinforcing CM may be one potential strategy to improve HIV outcomes among a select group of PWUD.",2020,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10 VL greater than control participants.","['From 2012-2017', 'HIV-infected people who use drugs', 'Thirty-seven participants', 'HIV-infected adults using', 'Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6']","['opioids or cocaine', 'Abstinence-reinforcing contingency management (CM', 'CM intervention', 'abstinence-reinforcing CM intervention', 'Abstinence-reinforcing contingency management']","['mean reduction in log 10 VL', 'log 10 VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes', 'HIV viral load suppression', 'HIV outcomes', 'HIV viral load (VL', 'abstinence or adherence']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",37.0,0.178726,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10 VL greater than control participants.","[{'ForeName': 'Chinazo O', 'Initials': 'CO', 'LastName': 'Cunningham', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States. Electronic address: ccunning@montefiore.org.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Arnsten', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Chenshu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Clemson University College of Behavioral, Social and Health Sciences, Department of Public Health Sciences, Clemson Nursing Building, 605 Grove Road, Greenville, SC 29605, United States.'}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Bachhuber', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Lousiana State University Health Sciences Center-New Orleans, Section of Community and Population Medicine, Department of Medicine, 533 Bolivar St, New Orleans, LA 70112, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Jost', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grossberg', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Stein', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Sohler', 'Affiliation': 'City University of New York, School of Medicine, 160 Convent Ave, New York, NY 10031, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108230']
2643,31578168,"Diagnostic accuracy of transbronchial lung cryobiopsy for interstitial lung disease diagnosis (COLDICE): a prospective, comparative study.","BACKGROUND
Transbronchial lung cryobiopsy (TBLC) is a novel technique for sampling lung tissue for interstitial lung disease diagnosis. The aim of this study was to establish the diagnostic accuracy of TBLC compared with surgical lung biopsy (SLB), in the context of increasing use of TBLC in clinical practice as a less invasive biopsy technique.
METHODS
COLDICE was a prospective, multicentre, diagnostic accuracy study investigating diagnostic agreement between TBLC and SLB, across nine Australian tertiary hospitals. Patients with interstitial lung disease aged between 18 and 80 years were eligible for inclusion if they required histopathological evaluation to aid diagnosis, after detailed baseline evaluation. After screening at a centralised multidisciplinary discussion (MDD), patients with interstitial lung disease referred for lung biopsy underwent sequential TBLC and SLB under one anaesthetic. Each tissue sample was assigned a number between 1 and 130, allocated in a computer-generated random sequence. Encoded biopsy samples were then analysed by masked pathologists. At subsequent MDD, de-identified cases were discussed twice with either TBLC or SLB along with clinical and radiological data, in random non-consecutive order. Co-primary endpoints were agreement of histopathological features in TBLC and SLB for patterns of definite or probable usual interstitial pneumonia, indeterminate for usual interstitial pneumonia, and alternative diagnosis; and for agreement of consensus clinical diagnosis using TBLC and SLB at MDD. Concordance and κ values were calculated for each primary endpoint. This study is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12615000718549.
FINDINGS
Between March 15, 2016, and April 15, 2019, we enrolled 65 patients (31 [48%] men, 34 [52%] women; mean age 66·1 years [SD 9·3]; forced vital capacity 83·7% [SD 14·2]; diffusing capacity for carbon monoxide 63·4% [SD 12·8]). TBLC (7·1 mm, SD 1·9) and SLB (46·5 mm, 14·9) samples were each taken from two separate ipsilateral lobes. Histopathological agreement between TBLC and SLB was 70·8% (weighted κ 0·70, 95% CI 0·55-0·86); diagnostic agreement at MDD was 76·9% (κ 0·62, 0·47-0·78). For TBLC with high or definite diagnostic confidence at MDD (39 [60%] of 65 cases), 37 (95%) were concordant with SLB diagnoses. In the 26 (40%) of 65 cases with low-confidence or unclassifiable TBLC diagnoses, SLB reclassified six (23%) to alternative high-confidence or definite MDD diagnoses. Mild-moderate airway bleeding occurred in 14 (22%) patients due to TBLC. The 90-day mortality was 2% (one of 65 patients), following acute exacerbation of idiopathic pulmonary fibrosis.
INTERPRETATION
High levels of agreement between TBLC and SLB for both histopathological interpretation and MDD diagnoses were shown. The TBLC MDD diagnoses made with high confidence were particularly reliable, showing excellent concordance with SLB MDD diagnoses. These data support the clinical utility of TBLC in interstitial lung disease diagnostic algorithms. Further studies investigating the safety profile of TBLC are needed.
FUNDING
University of Sydney, Hunter Medical Research Institute, Erbe Elektromedizin, Medtronic, Cook Medical, Rymed, Karl-Storz, Zeiss, and Olympus.",2020,"Histopathological agreement between TBLC and SLB was 70·8% (weighted κ 0·70, 95% CI 0·55-0·86); diagnostic agreement at MDD was 76·9% (κ 0·62, 0·47-0·78).","['interstitial lung disease diagnosis (COLDICE', 'Between March 15, 2016, and April 15, 2019', 'Patients with interstitial lung disease aged between 18 and 80 years were eligible for inclusion if they required histopathological evaluation to aid diagnosis, after detailed baseline evaluation', 'enrolled 65 patients (31 [48%] men, 34 [52%] women', 'patients with interstitial lung disease referred for lung biopsy underwent sequential TBLC and SLB under one anaesthetic', 'nine Australian tertiary hospitals']","['TBLC or SLB', 'Transbronchial lung cryobiopsy (TBLC', 'transbronchial lung cryobiopsy', 'TBLC and SLB', 'surgical lung biopsy (SLB', 'TBLC']","['Concordance and κ values', 'histopathological features in TBLC and SLB for patterns of definite or probable usual interstitial pneumonia, indeterminate for usual interstitial pneumonia, and alternative diagnosis', 'Histopathological agreement between TBLC and SLB', 'Mild-moderate airway bleeding', '90-day mortality']","[{'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0189485', 'cui_str': 'Biopsy of lung'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0189485', 'cui_str': 'Biopsy of lung'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0189485', 'cui_str': 'Biopsy of lung'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0205258', 'cui_str': 'Indeterminate'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",65.0,0.0467771,"Histopathological agreement between TBLC and SLB was 70·8% (weighted κ 0·70, 95% CI 0·55-0·86); diagnostic agreement at MDD was 76·9% (κ 0·62, 0·47-0·78).","[{'ForeName': 'Lauren K', 'Initials': 'LK', 'LastName': 'Troy', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia. Electronic address: ltroy@med.usyd.edu.au.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Grainge', 'Affiliation': 'John Hunter Hospital, New Lambton Heights, NSW, Australia; Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Tamera J', 'Initials': 'TJ', 'LastName': 'Corte', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Williamson', 'Affiliation': 'Liverpool Hospital, Liverpool, NSW, Australia; Macquarie University Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Vallely', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Macquarie University Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Cooper', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Annabelle', 'Initials': 'A', 'LastName': 'Mahar', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Myers', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbour, MI, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Mulyadi', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Torzillo', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Phillips', 'Affiliation': 'Macquarie University Hospital, Sydney, NSW, Australia; Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Jo', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Susanne E', 'Initials': 'SE', 'LastName': 'Webster', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Qi T', 'Initials': 'QT', 'LastName': 'Lin', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Rhodes', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Salamonsen', 'Affiliation': 'Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Wrobel', 'Affiliation': 'Fiona Stanley Hospital, Murdoch, WA, Australia; University of Notre Dame Australia, Fremantle, WA, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Harris', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Royal North Shore Hospital, Artarmon, NSW, Australia.'}, {'ForeName': 'Garrick', 'Initials': 'G', 'LastName': 'Don', 'Affiliation': 'Royal North Shore Hospital, Artarmon, NSW, Australia.'}, {'ForeName': 'Peter J C', 'Initials': 'PJC', 'LastName': 'Wu', 'Affiliation': 'Westmead Hospital, Westmead, NSW, Australia.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Ng', 'Affiliation': 'Nepean Hospital, Kingswood, NSW, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Edmund M T', 'Initials': 'EMT', 'LastName': 'Lau', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30342-X']
2644,31645648,A six-gene leukemic stem cell score identifies high risk pediatric acute myeloid leukemia.,"Recently, mRNA-expression signature enriched in LSCs was used to create a 17-gene leukemic stem cell (LSC17) score predictive of prognosis in adult AML. By fitting a Cox-LASSO regression model to the clinical outcome and gene-expression levels of LSC enriched genes in 163 pediatric participants of the AML02 multi-center clinical trial (NCT00136084), we developed a six-gene LSC score of prognostic value in pediatric AML (pLSC6). In the AML02 cohort, the 5-year event-free survival (EFS) of patients within low-pLSC6 group (n = 97) was 78.3 (95% CI = 70.5-86.9%) as compared with 34.5(95% CI = 24.7-48.2 %) in patients within high-pLSC6 group (n = 66 subjects), p < 0.00001. pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age. pLSC6 formula developed in the AML02 cohort was validated in the pediatric AML-TARGET project data (n = 205), confirming its prognostic value in both single-predictor and multiple-predictor Cox regression models. In both cohorts, pLSC6 predicted outcome of transplant patients, suggesting it as a useful criterion for transplant referrals. Our results suggest that pLSC6 score holds promise in redefining initial risk-stratification and identifying poor risk AML thereby providing guidance for developing novel treatment strategies.",2020,"pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age.","['risk pediatric acute myeloid leukemia', '163 pediatric participants']",['pLSC6'],"['EFS and overall survival (OS', '5-year event-free survival (EFS']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]",[],"[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",163.0,0.0725067,"pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age.","[{'ForeName': 'Abdelrahman H', 'Initials': 'AH', 'LastName': 'Elsayed', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Rafiee', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Raimondi', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Downing', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Ribeiro', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Tanja A', 'Initials': 'TA', 'LastName': 'Gruber', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Sharyn', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Klco', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Rubnitz', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Pounds', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jatinder K', 'Initials': 'JK', 'LastName': 'Lamba', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA. jlamba@cop.ufl.edu.'}]",Leukemia,['10.1038/s41375-019-0604-8']
2645,32854200,Feasibility and Clinical Usefulness of the Unified Protocol in Online Group Format for Bariatric Surgery Candidates: Study Protocol for a Multiple Baseline Experimental Design.,"Obesity is currently becoming a serious global public health problem due to its high prevalence and continuous increase. This condition is associated with different physical and mental health problems. The presence of emotional disorders (anxiety, depression and related disorders) among candidates for bariatric surgery is very high and predicts worse physical and psychological results. The present study aims to explore the feasibility and clinical usefulness of the Unified Protocol, a transdiagnostic emotion regulation-based intervention, delivered in an online group format to patients with emotional disorder diagnosis or symptoms, who are waiting for bariatric surgery. We will conduct a pilot study with a repeated single-case experimental design (multiple baseline design) in a public mental health service. The sample will consist of 60 participants, who will be randomized to three baseline conditions: 8, 12 or 15 evaluation days before the intervention. Diagnostic criteria, symptomatology and body mass index are the primary outcome measures, and we will include affectivity, personality, quality of life, body image, eating behavior and surgical complications like secondary measures. An analysis of treatment satisfaction will be also performed. Assessment points will include pre-treatment, baseline, treatment, post-treatment, and follow-ups every three months until two years after post-treatment. The results obtained in this study may have important clinical, social and economic implications for public mental health.",2020,"The presence of emotional disorders (anxiety, depression and related disorders) among candidates for bariatric surgery is very high and predicts worse physical and psychological results.","['patients with emotional disorder diagnosis or symptoms, who are waiting for bariatric surgery', 'public mental health service', '60 participants']",['transdiagnostic emotion regulation-based intervention'],"['affectivity, personality, quality of life, body image, eating behavior and surgical complications like secondary measures', 'emotional disorders (anxiety, depression and related disorders']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0542399', 'cui_str': 'Patient waiting for'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",60.0,0.0788091,"The presence of emotional disorders (anxiety, depression and related disorders) among candidates for bariatric surgery is very high and predicts worse physical and psychological results.","[{'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Quilez-Orden', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, 44003 Teruel, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Ferreres-Galán', 'Affiliation': 'Mental Health Unit of the Regional Hospital of Vinaròs, 12500 Castellón, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Osma', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, 44003 Teruel, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17176155']
2646,32855160,Glucose as the Fifth Vital Sign: A Randomized Controlled Trial of Continuous Glucose Monitoring in a Non-ICU Hospital Setting.,"OBJECTIVE
The current standard for hospital glucose management is point-of-care (POC) testing. We conducted a randomized controlled trial of real-time continuous glucose monitoring (RT-CGM) compared with POC in a non-intensive care unit (ICU) hospital setting.
RESEARCH DESIGN AND METHODS
A total of 110 adults with type 2 diabetes on a non-ICU floor received RT-CGM with Dexcom G6 versus usual care (UC). RT-CGM data were wirelessly transmitted from the bedside. Hospital telemetry monitored RT-CGM data and notified bedside nursing of glucose alerts and trends. Standardized protocols were used for interventions.
RESULTS
The RT-CGM group demonstrated significantly lower mean glucose (M∆ = -18.5 mg/dL) and percentage of time in hyperglycemia >250 mg/dL (-11.41%) and higher time in range 70-250 mg/dL (+11.26%) compared with UC ( P values <0.05). Percentage of time in hypoglycemia was very low.
CONCLUSIONS
RT-CGM can be used successfully in community-based hospital non-ICU settings to improve glucose management. Continuously streaming glucose readings may truly be the fifth vital sign.",2020,The RT-CGM group demonstrated significantly lower mean glucose,"['110 adults with type 2 diabetes (T2D) on a non-ICU floor received', 'in a Non-ICU Hospital Setting']","['RT-CGM', 'RT-CGM with Dexcom G6 versus usual care (UC', 'real-time CGM (RT-CGM', 'Continuous Glucose Monitoring']","['Percentage of time in hypoglycemia', 'percentage of time in hyperglycemia', 'higher median time', 'mean glucose']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",110.0,0.0208514,The RT-CGM group demonstrated significantly lower mean glucose,"[{'ForeName': 'Addie L', 'Initials': 'AL', 'LastName': 'Fortmann', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Samantha R', 'Initials': 'SR', 'LastName': 'Spierling Bagsic', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Talavera', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Isabel Maria', 'Initials': 'IM', 'LastName': 'Garcia', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Sandoval', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Amiry', 'Initials': 'A', 'LastName': 'Hottinger', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA tsimikas.athena@scrippshealth.org.'}]",Diabetes care,['10.2337/dc20-1016']
2647,32859100,Efficacy of a Multi-component m-Health Weight-loss Intervention in Overweight and Obese Adults: A Randomised Controlled Trial.,"BACKGROUND
This study compared the efficacy of two multi-component m-health interventions with a wait-list control group on body weight (primary outcome), and secondary outcomes of cardiovascular risk factors, lifestyle behaviours, and mental health.
METHODS
Three-arm randomised controlled trial (Enhanced: physical activity, diet, sleep, Traditional: physical activity, diet, Control) with assessments conducted at baseline, 6 and 12 months. Participants ( n = 116) were overweight or obese adults aged 19-65 (M = 44.5 [SD = 10.5]). The 6-month intervention was delivered via a smartphone app providing educational materials, goal-setting, self-monitoring and feedback, and also included one face-to-face dietary consultation, a Fitbit and scales. The trial was prospectively registered and conducted between May 2017 and September 2018. Group differences on primary and secondary outcomes were examined between the Pooled Intervention groups (Pooled Intervention = Enhanced and Traditional) and Control groups, and then between Enhanced and Traditional groups.
RESULTS
Nineteen participants (16.4%) formally withdrew from the trial. Compared with the Control group, average body weight of the Pooled Intervention group did not differ at 6 (between-group difference = -0.92, (95% CI -3.33, 1.48)) or 12 months (0.00, (95% CI -2.62, 2.62)). Compared with the Control group, the Pooled Intervention group significantly increased resistance training (OR = 7.83, (95% CI 1.08, 56.63)) and reduced energy intake at 6 months (-1037.03, (-2028.84, -45.22)), and improved insomnia symptoms at 12 months (-2.59, (-4.79, -0.39)). Compared with the Traditional group, the Enhanced group had increased waist circumferences (2.69, (0.20, 5.18)) and sedentary time at 6 months (105.66, (30.83, 180.48)), and improved bed time variability at 12 months (-1.08, (-1.86, -0.29)). No other significant differences were observed between groups.
CONCLUSIONS
Relative to Controls, the Pooled Intervention groups did not differ on body weight but improved resistance training, and reduced energy intake and insomnia symptom severity. No additional weight loss was apparent when targeting improvements in physical activity, diet and sleep in combination compared with physical activity and diet.",2020,"Compared with the Control group, the Pooled Intervention group significantly increased resistance training (OR = 7.83, (95% CI 1.08, 56.63)) and reduced energy intake at 6 months (-1037.03, (-2028.84, -45.22)), and improved insomnia symptoms at 12 months (-2.59, (-4.79, -0.39)).","['Nineteen participants (16.4%) formally withdrew from the trial', 'Overweight and Obese Adults', 'Participants ( n = 116) were overweight or obese adults aged 19-65 (M = 44.5 [SD = 10.5']","['physical activity, diet, sleep, Traditional: physical activity, diet, Control', 'Multi-component m-Health Weight-loss Intervention']","['sedentary time', 'weight loss', 'resistance training', 'bed time variability', 'cardiovascular risk factors, lifestyle behaviours, and mental health', 'physical activity, diet and sleep', 'insomnia symptoms', 'waist circumferences', 'body weight but improved resistance training, and reduced energy intake and insomnia symptom severity', 'reduced energy intake', 'average body weight']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517521', 'cui_str': '10.5'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",116.0,0.093777,"Compared with the Control group, the Pooled Intervention group significantly increased resistance training (OR = 7.83, (95% CI 1.08, 56.63)) and reduced energy intake at 6 months (-1037.03, (-2028.84, -45.22)), and improved insomnia symptoms at 12 months (-2.59, (-4.79, -0.39)).","[{'ForeName': 'Mitch J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'School of Medicine & Public Health, Faculty of Health and Medicine, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Fenton', 'Affiliation': 'School of Medicine & Public Health, Faculty of Health and Medicine, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Brown', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, QLD 4067, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Glozier', 'Affiliation': 'Brain and Mind Centre, Central Clinical School, The University of Sydney, 94 Mallett St, Camperdown, NSW 2050, Australia.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Kolt', 'Affiliation': 'School of Health Sciences, Western Sydney University, Penrith, NSW 2751, Australia.'}, {'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Holliday', 'Affiliation': 'School of Medicine & Public Health, Faculty of Health and Medicine, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Murawski', 'Affiliation': 'School of Medicine & Public Health, Faculty of Health and Medicine, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Plotnikoff', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Anna T', 'Initials': 'AT', 'LastName': 'Rayward', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Stamatakis', 'Affiliation': 'Charles Perkins Centre, Faculty of Medicine and Health, School of Health Sciences, Sydney 2006, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'Physical Activity Research Group, Appleton Institute, School of Health, Medical and Applied Science, Central Queensland University, Rockhampton, QLD 4700, Australia.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Burrows', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17176200']
2648,32864921,Nursing Guidelines on Cardiac Surgery and Parents' Anxiety: Randomized Clinical Trial.,"OBJECTIVE
The preparation of parents of children who should undergo cardiac surgery requires special treatment such as the explanations about the event. This study aims to compare the effects of standardized nursing guidelines with routine institutional orientation on the anxiety of parents of children undergoing cardiac surgery.
METHODS
Randomized clinical trial. The sample consisted of parents of children who underwent cardiac surgery from December 2010 to April 2011. Twenty-two parents were randomized to the intervention group (IG) and received the standard nursing guidelines and 22 participated in the control group (CG) and received the routine guidelines from the institution. Anxiety was assessed by the State-Trait Anxiety Inventory (STAI) applied in the preoperative period, between 12 and 20 hours before surgery and before receiving standard or institutional guidelines and 48 hours after surgery. The analysis of variance (ANOVA) for repeated measures was performed to evaluate the differences between the variations in STAI scores between the groups during the studied period. The level of significance was 0.05.
RESULTS
There were no significant differences in baseline anxiety scores between groups with regard to trait anxiety as well as state anxiety: STAI-trait (CG 42.6±4.9 vs. IG 41.4±6.0, P=0.48); STAI-state (CG 42.3±5.7 vs. IG 45.6±8.3, P=0.18). Likewise, the variation in score after 48 hours was similar between groups (STAI-trait P=0.77; STAI-state P=0.61).
CONCLUSION
There were no significant differences in the parents' anxiety levels when comparing the two types of guidelines: the standard nursing and the institutional orientation.",2020,"There were no significant differences in baseline anxiety scores between groups with regard to trait anxiety as well as state anxiety: STAI-trait (CG 42.6±4.9 vs. IG 41.4±6.0, P=0.48); STAI-state (CG 42.3±5.7 vs. IG 45.6±8.3, P=0.18).","['parents of children undergoing cardiac surgery', 'parents of children who underwent cardiac surgery from December 2010 to April 2011', ""Cardiac Surgery and Parents' Anxiety""]","['standardized nursing guidelines with routine institutional orientation', 'standard nursing guidelines and 22 participated in the control group (CG']","['Anxiety', ""parents' anxiety levels"", 'State-Trait Anxiety Inventory (STAI', 'baseline anxiety scores', 'STAI scores']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",22.0,0.0675065,"There were no significant differences in baseline anxiety scores between groups with regard to trait anxiety as well as state anxiety: STAI-trait (CG 42.6±4.9 vs. IG 41.4±6.0, P=0.48); STAI-state (CG 42.3±5.7 vs. IG 45.6±8.3, P=0.18).","[{'ForeName': 'Ilsa Beatriz Machado', 'Initials': 'IBM', 'LastName': 'Xavier', 'Affiliation': 'Instituto de Cardiologia/Fundação Universitária de Cardiologia - IC/FUC, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Virginia Borne', 'Initials': 'VB', 'LastName': 'Biscarra', 'Affiliation': 'Instituto de Cardiologia/Fundação Universitária de Cardiologia - IC/FUC, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ângela Bein', 'Initials': 'ÂB', 'LastName': 'Piccoli', 'Affiliation': 'Instituto de Cardiologia/Fundação Universitária de Cardiologia - IC/FUC, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Clarissa Garcia', 'Initials': 'CG', 'LastName': 'Rodrigues', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Vania Naomi', 'Initials': 'VN', 'LastName': 'Hirakata', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Maria Antonieta Pereira de', 'Initials': 'MAP', 'LastName': 'Moraes', 'Affiliation': 'Instituto de Cardiologia/Fundação Universitária de Cardiologia - IC/FUC, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Lucia Campos', 'Initials': 'LC', 'LastName': 'Pellanda', 'Affiliation': 'Instituto de Cardiologia/Fundação Universitária de Cardiologia - IC/FUC, Porto Alegre, RS, Brazil.'}]",Brazilian journal of cardiovascular surgery,['10.21470/1678-9741-2019-0345']
2649,32865004,Renal and Cardiovascular Effects of SGLT2 Inhibition in Combination With Loop Diuretics in Patients With Type 2 Diabetes and Chronic Heart Failure: The RECEDE-CHF Trial.,"BACKGROUND
SGLT2 (sodium-glucose cotransporter-2) inhibitors improve heart failure-associated outcomes in patients with type 2 diabetes. In patients with heart failure, SGLT2 inhibitors will likely be coprescribed with a loop diuretic, but this combined effect is not well-defined. Our aim was to assess the diuretic and natriuretic effect of empagliflozin in combination with loop diuretics.
METHODS
The RECEDE-CHF trial (SGLT2 Inhibition in Combination With Diuretics in Heart Failure) was a randomized, double-blind, placebo-controlled, crossover trial of patients with type 2 diabetes and heart failure with reduced ejection fraction taking regular loop diuretic who were randomized to empagliflozin 25 mg once daily or placebo for 6 weeks with a 2-week washout period. The primary outcome was change in 24-hour urinary volume from baseline to week 6.
RESULTS
Twenty-three participants (mean age, 69.8 years; 73.9% male; mean furosemide dose, 49.6±31.3 mg/d; mean HbA1c, 7.9±3.8%) were recruited. Compared with placebo, empagliflozin caused a significant increase in 24-hour urinary volume at both day 3 (mean difference, 535 mL [95% CI, 133-936]; P =0.005) and week 6 (mean difference, 545 mL [95% CI, 136-954]; P =0.005) after adjustment for treatment order, baseline 24-hour urine volume, and percentage change in loop diuretic dose. At 6 weeks, empagliflozin did not cause a significant change in 24-hour urinary sodium (mean difference, -7.85 mmol/L [95% CI, -2.43 to 6.73]; P =0.57). Empagliflozin caused a nonsignificant increase in fractional excretion of sodium at day 3, which was absent at week 6 (mean difference day 3, 0.30% [95% CI, -0.03 to 0.63]; P =0.09; week 6, 0.11% [95% CI, -0.22 to 0.44]; P >0.99), and a significant increase in electrolyte-free water clearance at week 6 (mean difference, 312 mL [95% CI, 26-598]; P =0.026) compared with placebo. Empagliflozin also caused significant reductions in body weight and serum urate at week 6.
CONCLUSIONS
Empagliflozin caused a significant increase in 24-hour urine volume without an increase in urinary sodium when used in combination with loop diuretic. Registration: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT03226457.",2020,"Compared to placebo, empagliflozin caused a significant increase in 24-hour urinary volume at both day 3 (mean difference 535 ml, 95% CI 133 to 936, p =0.005) and week 6, (mean difference 545 ml, 95% CI 136 to 954 p = 0.005) after adjustment for treatment order, baseline 24-hour urine volume and percentage change in loop diuretic dose.","['Patients with Type 2 Diabetes and Chronic Heart Failure', 'Results: Twenty-three participants (mean age 69.8 years, 73.9% male, mean furosemide dose of 49.6±31.3mg/day, mean HbA1c 7.9±3.8%) were recruited', 'patients with type 2 diabetes (T2D', 'patients with T2D and HF with reduced ejection fraction taking regular loop diuretic']","['empagliflozin', 'placebo, empagliflozin', 'Transporter-2 (SGLT2) inhibitors', 'SGLT2 Inhibition in Combination with Loop Diuretics', 'placebo', 'Sodium-Glucose Co', 'empagliflozin 25 mg once daily or placebo', 'Empagliflozin']","['24-hour urinary volume', 'body weight and serum urate', 'electrolyte-free water clearance', '24-hour urinary sodium', 'diuretic and natriuretic effect', '24-hour urine volume', 'fractional excretion of sodium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0354100', 'cui_str': 'Loop diuretic'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0596902', 'cui_str': 'Membrane Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1505133', 'cui_str': 'SLC5A2 protein, human'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0354100', 'cui_str': 'Loop diuretic'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C3848772', 'cui_str': 'empagliflozin 25 MG [Jardiance]'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0429776', 'cui_str': '24 hour urine output'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0232830', 'cui_str': 'Free water clearance'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C3179308', 'cui_str': 'Natriuretic Effects'}, {'cui': 'C0427843', 'cui_str': '24 hour urine sample volume measurement'}, {'cui': 'C0428601', 'cui_str': 'Measurement of fractional excretion of sodium'}]",,0.58409,"Compared to placebo, empagliflozin caused a significant increase in 24-hour urinary volume at both day 3 (mean difference 535 ml, 95% CI 133 to 936, p =0.005) and week 6, (mean difference 545 ml, 95% CI 136 to 954 p = 0.005) after adjustment for treatment order, baseline 24-hour urine volume and percentage change in loop diuretic dose.","[{'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Mordi', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Scotland, United Kingdom (N.A.M., I.R.M., R.J.M., A.D.S., C.C.L.).'}, {'ForeName': 'Ify R', 'Initials': 'IR', 'LastName': 'Mordi', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Scotland, United Kingdom (N.A.M., I.R.M., R.J.M., A.D.S., C.C.L.).'}, {'ForeName': 'Jagdeep S', 'Initials': 'JS', 'LastName': 'Singh', 'Affiliation': 'Royal Infirmary of Edinburgh, Scotland, United Kingdom (J.D.S.).'}, {'ForeName': 'Rory J', 'Initials': 'RJ', 'LastName': 'McCrimmon', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Scotland, United Kingdom (N.A.M., I.R.M., R.J.M., A.D.S., C.C.L.).'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Scotland, United Kingdom (N.A.M., I.R.M., R.J.M., A.D.S., C.C.L.).'}, {'ForeName': 'Chim C', 'Initials': 'CC', 'LastName': 'Lang', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Scotland, United Kingdom (N.A.M., I.R.M., R.J.M., A.D.S., C.C.L.).'}]",Circulation,['10.1161/CIRCULATIONAHA.120.048739']
2650,32862111,Interferon β-1b in treatment of severe COVID-19: A randomized clinical trial.,"In this study, efficacy and safety of interferon (IFN) β-1b in the treatment of patients with severe COVID-19 were evaluated. Among an open-label, randomized clinical trial, adult patients (≥18 years old) with severe COVID-19 were randomly assigned (1:1) to the IFN group or the control group. Patients in the IFN group received IFN β-1b (250 mcg subcutaneously every other day for two consecutive weeks) along with the national protocol medications while in the control group, patients received only the national protocol medications (lopinavir/ritonavir or atazanavir/ritonavir plus hydroxychloroquine for 7-10 days). The primary outcome of the study was time to clinical improvement. Secondary outcomes were in-hospital complications and 28-daymortality. Between April 20 and May 20, 2020, 80 patients were enrolled and finally 33 patients in each group completed the study. Time to clinical improvment in the IFN group was significantly shorter than the control group ([9(6-10) vs. 11(9-15) days respectively, p = 0.002, HR = 2.30; 95% CI: 1.33-3.39]). At day 14, the percentage of discharged patients was 78.79% and 54.55% in the IFN and control groups respectively (OR = 3.09; 95% CI: 1.05-9.11, p = 0.03). ICU admission rate in the control group was significantly higher than the IFN group (66.66% vs. 42.42%, p = 0.04). The duration of hospitalization and ICU stay were not significantly different between the groups All-cause 28-day mortality was 6.06% and 18.18% in the IFN and control groups respectively (p = 0.12). IFN β-1b was effective in shortening the time to clinical improvement without serious adverse events in patients with severe COVID-19. Furthermore, admission in ICU and need for invasive mechanical ventilation decreased following administration of IFN β-1b. Although 28-day mortality was lower in the IFN group, further randomized clinical trials with large sample size are needed for exact estimation of survival benefit of IFN β-1b.",2020,The duration of hospitalization and ICU stay were not significantly different between the groups All-cause 28-day mortality was 6.06% and 18.18% in the IFN and control groups respectively (,"['patients with severe COVID-19', 'severe COVID-19', 'patients with severe COVID-19 were evaluated', 'adult patients (≥18\xa0years old) with severe COVID-19', 'Between April 20 and May 20, 2020, 80 patients were enrolled and finally 33 patients in each group completed the study']","['interferon (IFN) β-1b', 'IFN', 'IFN β-1b', 'national protocol medications (lopinavir/ritonavir or atazanavir/ritonavir plus hydroxychloroquine', 'Interferon β-1b']","['ICU admission rate', 'Time to clinical improvment', '28-day mortality', 'invasive mechanical ventilation', 'hospital complications and 28-daymortality', 'duration of hospitalization and ICU stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",80.0,0.104399,The duration of hospitalization and ICU stay were not significantly different between the groups All-cause 28-day mortality was 6.06% and 18.18% in the IFN and control groups respectively (,"[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rahmani', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Davoudi-Monfared', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Anahid', 'Initials': 'A', 'LastName': 'Nourian', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: khalilih@tums.ac.ir.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Hajizadeh', 'Affiliation': 'Department of Infectious Diseases, Shohadaye Gomnam Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Narjes Zarei', 'Initials': 'NZ', 'LastName': 'Jalalabadi', 'Affiliation': 'Department of Internal Medicine, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Fazeli', 'Affiliation': 'Department of Food and Drug Control, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Monireh', 'Initials': 'M', 'LastName': 'Ghazaeian', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran Univesity of Medical Sciences, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}]",International immunopharmacology,['10.1016/j.intimp.2020.106903']
2651,32863275,Cost-effectiveness of robotic hysterectomy versus abdominal hysterectomy in early endometrial cancer.,"OBJECTIVES
To compare total costs for hospital stay and post-operative recovery between robotic and abdominal hysterectomy in the treatment of early-stage endometrial cancer provided in an enhanced recovery after surgery (ERAS) setting. Costs were evaluated in relation to health impact, taking a societal perspective.
METHODS
Cost analysis was based on data from an open randomized controlled trial in an ERAS setting at a Swedish tertiary referral university hospital: 50 women with low-risk endometrial cancer scheduled for surgery between February 2012 and May 2016 were included; 25 women were allocated to robotic and 25 to abdominal hysterectomy. We compared the total time in the operating theater, procedure costs, post-operative care, length of hospital stay, readmissions, informal care, and sick leave as well as the health-related quality of life until 6 weeks after surgery. The comparison was made by using the EuroQoL group form with five dimensions and three levels (EQ-5D). The primary outcome measure was total cost; secondary outcomes were quality-adjusted life-years (QALYs) and cost per QALY. The costs were calculated in Swedish Krona (SEK).
RESULTS
Age (median (IQR) 68 (63-72) vs 67 (59-75) years), duration of hospital stay (ie, time to discharge criteria were met) (median (IQR) 36 (36-36) vs 36 (36-54) hours), and sick leave (median (IQR) 25 (17-30) vs 31 (36-54) days) did not differ between the robotic and abdominal group. Time of surgery was significantly longer in the robotic group than in the abdominal group (median (IQR) 70 (60-90) vs 56 (49-84) min; p<0.05). The robotic group recovered significantly faster as measured by the EQ-5D health index and gained 0.018 QALYs until 6 weeks after surgery. Total costs were 20% higher for the robotic procedure (SEK71 634 vs SEK59 319). The total cost per QALY gained for women in the robotic group was slightly under SEK700 000.
CONCLUSIONS
Robotic hysterectomy used in an ERAS setting in the treatment of early endometrial cancer improved health within 6 weeks after the operation at a high cost for the health gained compared with abdominal hysterectomy. The productivity loss and informal care were lower for robotic hysterectomy, while healthcare had a higher procedure cost that could not be offset by the higher cost due to complications in the abdominal group.",2020,The robotic group recovered significantly faster as measured by the EQ-5D health index and gained 0.018 QALYs until 6 weeks after surgery.,"['ERAS setting at a Swedish tertiary referral university hospital: 50 women with low-risk endometrial cancer scheduled for surgery between February 2012 and May 2016 were included; 25 women', 'early-stage endometrial cancer', 'early endometrial cancer']","['Robotic hysterectomy', 'robotic and 25 to abdominal hysterectomy', 'robotic hysterectomy versus abdominal hysterectomy', 'robotic and abdominal hysterectomy']","['Time of surgery', 'productivity loss and informal care', 'Total costs', 'EQ-5D health index', 'sick leave', 'duration of hospital stay ', 'total cost; secondary outcomes were quality-adjusted life-years (QALYs) and cost per QALY', 'total cost per QALY gained', 'total time in the operating theater, procedure costs, post-operative care, length of hospital stay, readmissions, informal care, and sick leave as well as the health-related quality of life']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C3494177', 'cui_str': 'Informal care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",25.0,0.184568,The robotic group recovered significantly faster as measured by the EQ-5D health index and gained 0.018 QALYs until 6 weeks after surgery.,"[{'ForeName': 'Evelyn Serreyn', 'Initials': 'ES', 'LastName': 'Lundin', 'Affiliation': 'Department of Obstetrics and Gynecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköpings Universitet, Linköping, Sweden evelyn.lundin@regionostergotland.se.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlsson', 'Affiliation': 'Division of Society and Health, Department of Health, Medicine and Caring Sciences, Linköpings Universitet, Linköping, Sweden.'}, {'ForeName': 'Ninnie Borendal', 'Initials': 'NB', 'LastName': 'Wodlin', 'Affiliation': 'Department of Obstetrics and Gynecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköpings Universitet, Linköping, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Nilsson', 'Affiliation': 'Department of Anesthesiology and Intensive Care in Linköping, and Department of Biomedical and Clinical Sciences, Linköpings Universitet, Linköping, Sweden.'}, {'ForeName': 'Preben', 'Initials': 'P', 'LastName': 'Kjölhede', 'Affiliation': 'Department of Obstetrics and Gynecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköpings Universitet, Linköping, Sweden.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001611']
2652,32864805,"Single-Agent Versus Double-Agent Chemotherapy in Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: Prospective, Randomized, Multicenter Phase II Clinical Trial.","LESSONS LEARNED
The efficacy of single-agent chemotherapy was not significantly different from that of double-agent chemotherapy in concurrent chemoradiotherapy for inoperable esophageal squamous cell carcinoma. Single-agent concurrent chemoradiotherapy had lower gastrointestinal and hematologic toxicity. Overall survival and progression-free survival were not significantly different between single- and double-agent concurrent chemoradiotherapy.
BACKGROUND
This multicenter, randomized, phase II trial aimed to compare the efficacy and safety of single-agent concurrent chemoradiotherapy using the oral fluoropyrimidine S-1 with those of double-agent concurrent chemoradiotherapy using S-1 and cisplatin in patients with inoperable esophageal squamous cell carcinoma.
METHODS
Patients with inoperable esophageal squamous cell carcinoma (clinical stages I to III) were randomly allocated to the single-agent group (S-1) or the double-agent group (S-1/cisplatin). The concurrent intensity-modulated radiation therapy plan was similar for both groups: planning target volume 1.8 Gy/f*30-33f and planning gross target volume of 2 Gy/f*30-33f. The primary outcome measure was the endoscopic complete response rate.
RESULTS
Of the 105 patients randomized, 89 were assessable. The endoscopic complete response rate was 46.9% (23/49) in the single-agent group and 52.5% (21/40) in double-agent group. The median progression-free survival within a median follow-up of 23 months was 20 and 21 months, respectively. The median overall survival was 26 months and not reached, respectively. Grade 3 hematological toxicities occurred in 4.1% and 27.5% of the patients in the single- and the double-agent group, respectively.
CONCLUSION
Single-agent chemotherapy in concurrent chemoradiotherapy for inoperable esophageal squamous cell carcinoma has good efficacy and safety, thus warranting a phase III trial.",2020,The efficacy of single-agent chemotherapy was not significantly different from that of double-agent chemotherapy in concurrent chemoradiotherapy for inoperable esophageal squamous cell carcinoma.,"['Patients with inoperable esophageal squamous cell carcinoma (clinical stages I to III', 'patients with inoperable esophageal squamous cell carcinoma', 'inoperable esophageal squamous cell carcinoma', '105 patients randomized', 'Esophageal Squamous Cell Carcinoma']","['fluoropyrimidine S-1 with those of double-agent concurrent chemoradiotherapy using S-1 and cisplatin', 'single-agent concurrent chemoradiotherapy', 'Single-Agent Versus Double-Agent Chemotherapy', 'Single-agent concurrent chemoradiotherapy', 'single-agent chemotherapy', 'single-agent group (S-1) or the double-agent group (S-1/cisplatin', 'Single-agent chemotherapy']","['efficacy and safety', 'endoscopic complete response rate', 'median overall survival', 'median progression-free survival', 'Overall survival and progression-free survival', 'lower gastrointestinal and hematologic toxicity', 'Grade 3 hematological toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0205564', 'cui_str': 'Clinical stage I'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]",105.0,0.180995,The efficacy of single-agent chemotherapy was not significantly different from that of double-agent chemotherapy in concurrent chemoradiotherapy for inoperable esophageal squamous cell carcinoma.,"[{'ForeName': 'Zhenhuan', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': ""Department of Oncology, Mianyang Central Hospital, Mianyang, People's Republic of China.""}, {'ForeName': 'Yixue', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': ""Department of Oncology, Mianyang Central Hospital, Mianyang, People's Republic of China.""}, {'ForeName': 'Dongbiao', 'Initials': 'D', 'LastName': 'Liao', 'Affiliation': ""Department of Oncology, Mianyang Central Hospital, Mianyang, People's Republic of China.""}, {'ForeName': 'Jidong', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': ""Department of Oncology, Zigong Fourth People's Hospital, Zi Gong, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gui', 'Affiliation': ""Department of Oncology, Affiliated Hospital of North Sichuan Medical College, Nan Chong, People's Republic of China.""}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': ""Department of Oncology, Lang Zhong People's Hospital, Lang Zhong, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Oncology, Jianyang People's Hospital, Jian Yang, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': ""Department of Oncology, Ziyang People's Hospital, Zi Yang, People's Republic of China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Jia', 'Affiliation': ""Department of Oncology, Jiangyou Second People's Hospital, Jiang You, People's Republic of China.""}, {'ForeName': 'Honggang', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': ""Department of Oncology, Jiangyou People's Hospital, Jiang You, People's Republic of China.""}, {'ForeName': 'Mingqiang', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': ""Department of Oncology, Guangyuan First People's Hospital, Guang Yuan, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, Mianyang Central Hospital, Mianyang, People's Republic of China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Feng', 'Affiliation': ""Department of Oncology, Mianyang Central Hospital, Mianyang, People's Republic of China.""}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': ""Department of Oncology, Mianyang Central Hospital, Mianyang, People's Republic of China.""}]",The oncologist,['10.1634/theoncologist.2020-0808']
2653,32868782,Asthma exacerbations and worsenings in patients aged 1-75 years with add-on tiotropium treatment.,"This review explores the effect of tiotropium Respimat® add-on therapy on asthma exacerbations and worsenings, adverse events (AEs) related to exacerbations and symptoms and any effects on seasonality across the 10 UniTinA-asthma® clinical trials comprising over 6000 patients. When added on to inhaled corticosteroids ± additional therapies, tiotropium significantly reduced the risk of exacerbations and worsenings in adults with symptomatic severe asthma and provided a non-significant improvement in worsenings in adults with symptomatic moderate and mild asthma, which was significant for patients with moderate asthma receiving tiotropium 2.5 µg once daily vs. placebo. Trials in paediatric patients were not powered to assess exacerbations or worsenings, but when AEs related to asthma exacerbations and symptoms were grouped into a composite endpoint and pooled, tiotropium improved outcomes vs. placebo (rate ratio 0.76; 95% confidence interval 0.63, 0.93). The reduction in exacerbations with tiotropium is apparent across all patients during the observed seasonal peaks of these events.",2020,"When added on to inhaled corticosteroids ± additional therapies, tiotropium significantly reduced the risk of exacerbations and worsenings in adults with symptomatic severe asthma and provided a non-significant improvement in worsenings in adults with symptomatic moderate and mild asthma, which was significant for patients with moderate asthma receiving tiotropium 2.5 µg once daily vs. placebo.","['patients aged 1-75 years with add-on tiotropium treatment', 'paediatric patients', 'adults with symptomatic severe asthma', '6000 patients']","['tiotropium Respimat®', 'placebo', 'tiotropium']",['risk of exacerbations and worsenings'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C3842326', 'cui_str': '6000'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}]",6000.0,0.666766,"When added on to inhaled corticosteroids ± additional therapies, tiotropium significantly reduced the risk of exacerbations and worsenings in adults with symptomatic severe asthma and provided a non-significant improvement in worsenings in adults with symptomatic moderate and mild asthma, which was significant for patients with moderate asthma receiving tiotropium 2.5 µg once daily vs. placebo.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark FitzGerald', 'Affiliation': 'Centre for Heart and Lung Health, Vancouver, BC, Canada. Mark.Fitzgerald@vch.ca.'}, {'ForeName': 'Eckard', 'Initials': 'E', 'LastName': 'Hamelmann', 'Affiliation': 'Klinik für Kinder- und Jugendmedizin, Evangelisches Klinikum Bethel, Bielefeld, Germany.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonology and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg University Hospital Mainz, Mainz, Germany.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-020-00193-w']
2654,32872501,Acceptability and Feasibility of Best Practice School Lunches by Elementary School-Aged Children in a Serve Setting: A Randomized Crossover Trial.,"BACKGROUND
National School Lunch Program (NSLP) standards have improved school lunch dietary quality (DQ), however, further improvements could be made. Acceptability and feasibility of higher DQ are potential barriers. Thus, the purpose is to compare acceptability and feasibility of best practice (BPSL, optimizing DQ) with typical school lunches (TSL, meeting minimum NSLP standards) served separately and concurrently.
METHODS
Forty elementary school-aged participants were recruited for a randomized crossover trial. Participants attended three meal conditions (MC) choosing one of two meal types-MC1) BPSL1/BPSL2, MC2) TSL1/TSL2, MC3) BPSL/TSL. Acceptability included taste test surveys, weighted plate waste assessments, and hunger scales. Feasibility included meal cost, time, and skill and equipment requirements.
RESULTS
There were no significant differences in total taste test score, average total plate waste, or change in hunger ( ps > 0.017) before or after adjusting for covariates. TSL was selected significantly more often in MC3 (TSL = 83.3%, BPSL = 16.7%, p = 0.001). Meal cost ( p = 0.783) and skill and equipment requirements were not significantly different between meal types. BPSL required significantly longer preparation time (TSL = 60 ± 25 min, BPSL = 267 ± 101 min, p = 0.026).
CONCLUSIONS
Results indicate few differences in acceptability and feasibility between BPSL and TSL. This study could inform decision and policy-makers seeking to improve school lunch DQ and acceptance of higher DQ meals.",2020,"BPSL required significantly longer preparation time (TSL = 60 ± 25 min, BPSL = 267 ± 101 min, p = 0.026).
","['Forty elementary school-aged participants', 'Elementary School-Aged Children in a Serve Setting']","['meal conditions (MC) choosing one of two meal types-MC1) BPSL1/BPSL2, MC2) TSL1/TSL2, MC3) BPSL/TSL']","['meal cost, time, and skill and equipment requirements', 'acceptability and feasibility', 'longer preparation time', 'Acceptability and Feasibility', 'total taste test score, average total plate waste, or change in hunger', 'TSL', 'Meal cost', 'skill and equipment requirements', 'school lunch dietary quality (DQ', 'Acceptability included taste test surveys, weighted plate waste assessments, and hunger scales']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3697854', 'cui_str': 'Equipment requirement'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",40.0,0.0554998,"BPSL required significantly longer preparation time (TSL = 60 ± 25 min, BPSL = 267 ± 101 min, p = 0.026).
","[{'ForeName': 'Jillian M', 'Initials': 'JM', 'LastName': 'Joyce', 'Affiliation': 'Department of Nutritional Sciences, Oklahoma State University, Stillwater, OK 74078, USA.'}, {'ForeName': 'Kyleen', 'Initials': 'K', 'LastName': 'Harris', 'Affiliation': 'Department of Food, Nutrition, Dietetics and Health, Kansas State University, Manhattan, KS 66506, USA.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Mailey', 'Affiliation': 'Department of Kinesiology, Kansas State University, Manhattan, KS 66506, USA.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Rosenkranz', 'Affiliation': 'Department of Food, Nutrition, Dietetics and Health, Physical Activity and Nutrition Clinical Research Consortium, Kansas State University, Manhattan, KS 66506, USA.'}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Rosenkranz', 'Affiliation': 'Department of Food, Nutrition, Dietetics and Health, Physical Activity and Nutrition Clinical Research Consortium, Kansas State University, Manhattan, KS 66506, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17176299']
2655,32873681,Mesothelioma and Radical Surgery 2 (MARS 2): protocol for a multicentre randomised trial comparing (extended) pleurectomy decortication versus no (extended) pleurectomy decortication for patients with malignant pleural mesothelioma.,"INTRODUCTION
Mesothelioma remains a lethal cancer. To date, systemic therapy with pemetrexed and a platinum drug remains the only licensed standard of care. As the median survival for patients with mesothelioma is 12.1 months, surgery is an important consideration to improve survival and/or quality of life. Currently, only two surgical trials have been performed which found that neither extensive (extra-pleural pneumonectomy) or limited (partial pleurectomy) surgery improved survival (although there was some evidence of improved quality of life). Therefore, clinicians are now looking to evaluate pleurectomy decortication, the only radical treatment option left.
METHODS AND ANALYSIS
The MARS 2 study is a UK multicentre open parallel group randomised controlled trial comparing the effectiveness and cost-effectiveness of surgery-(extended) pleurectomy decortication-versus no surgery for the treatment of pleural mesothelioma. The study will test the hypothesis that surgery and chemotherapy is superior to chemotherapy alone with respect to overall survival. Secondary outcomes include health-related quality of life, progression-free survival, measures of safety (adverse events) and resource use to 2 years. The QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.
ETHICS AND DISSEMINATION
Research ethics approval was granted by London - Camberwell St. Giles Research Ethics Committee (reference 13/LO/1481) on 7 November 2013. We will submit the results for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBERS
ISRCTN-ISRCTN44351742 and ClinicalTrials.gov-NCT02040272.",2020,The MARS 2 study is a UK multicentre open parallel group randomised controlled trial comparing the effectiveness and cost-effectiveness of surgery-(extended) pleurectomy decortication-versus no surgery for the treatment of pleural mesothelioma.,"['pleural mesothelioma', 'patients with malignant pleural mesothelioma']","['surgery-(extended) pleurectomy decortication-versus no surgery', 'pleurectomy decortication versus no (extended) pleurectomy decortication']","['health-related quality of life, progression-free survival, measures of safety (adverse events) and resource use to 2 years', 'survival and/or quality of life', 'quality of life', 'survival', 'overall survival', 'median survival']","[{'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0152463', 'cui_str': 'Pleurectomy'}, {'cui': 'C0007778', 'cui_str': 'Brain decortication'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.206517,The MARS 2 study is a UK multicentre open parallel group randomised controlled trial comparing the effectiveness and cost-effectiveness of surgery-(extended) pleurectomy decortication-versus no surgery for the treatment of pleural mesothelioma.,"[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lim', 'Affiliation': 'Academic Division of Thoracic Surgery, Royal Brompton and Harefield NHS Trust, London, UK e.lim@rbht.nhs.uk.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Darlison', 'Affiliation': 'The Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Edwards', 'Affiliation': 'Cardiothoracic Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Elliott', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Fennell', 'Affiliation': 'Cancer Research UK Centre Leicester, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Popat', 'Affiliation': 'Department of Medicine, Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Rintoul', 'Affiliation': 'Department of Thoracic Oncology, Papworth Hospital NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Waller', 'Affiliation': 'Department of Thoracic Surgery, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Clinton', 'Initials': 'C', 'LastName': 'Ali', 'Affiliation': 'The Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, Glasgow, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bille', 'Affiliation': ""Thoracic Surgery, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Fuller', 'Affiliation': 'Respiratory Medicine, South Tyneside NHS Foundation Trust, South Shields, UK.'}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Ionescu', 'Affiliation': 'Lung Cancer, Aneurin Bevan University Health Board, Newport, UK.'}, {'ForeName': 'Manjusha', 'Initials': 'M', 'LastName': 'Keni', 'Affiliation': 'Oncology, Derby Teaching Hospitals NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kirk', 'Affiliation': 'Department of Thoracic Surgery, Golden Jubilee National Hospital, Clydebank, UK.'}, {'ForeName': 'Pek', 'Initials': 'P', 'LastName': 'Koh', 'Affiliation': 'Department of Oncology, New Cross Hospital, Wolverhampton, UK.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Lau', 'Affiliation': 'Department of Thoracic Surgery, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Talal', 'Initials': 'T', 'LastName': 'Mansy', 'Affiliation': 'Oncology, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Milton', 'Affiliation': 'Thoracic Surgery Department, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Dakshinamoorthy', 'Initials': 'D', 'LastName': 'Muthukumar', 'Affiliation': 'Oncology, Colchester Hospital University NHS Foundation Trust, Colchester, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Pope', 'Affiliation': 'Clatterbridge Cancer Centre, Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Plymouth Oncology Centre, University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'Riyaz', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Kent Oncology Centre, Maidstone and Tunbridge Wells NHS Trust, Maidstone, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shamash', 'Affiliation': 'Department of Medical Oncology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Zacharias', 'Initials': 'Z', 'LastName': 'Tasigiannopoulos', 'Affiliation': 'The Oncology Care Team, Norfolk and Norwich University Hospital NHS Trust, Norwich, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Taylor', 'Affiliation': 'Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Treece', 'Affiliation': 'Heamatology and Oncology Unit, North West Anglia NHS Foundation Trust, Peterborough, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ashton', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Joyce', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Warnes', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Mills', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Stokes', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038892']
2656,32883018,Digital Training for Non-Specialist Health Workers to Deliver a Brief Psychological Treatment for Depression in Primary Care in India: Findings from a Randomized Pilot Study.,"Introduction : Task sharing holds promise for scaling up depression care in countries such as India, yet requires training large numbers of non-specialist health workers. This pilot trial evaluated the feasibility and acceptability of a digital program for training non-specialist health workers to deliver a brief psychological treatment for depression. Methods : Participants were non-specialist health workers recruited from primary care facilities in Sehore, a rural district in Madhya Pradesh, India. A three-arm randomized controlled trial design was used, comparing digital training alone (DGT) to digital training with remote support (DGT+), and conventional face-to-face training. The primary outcome was the feasibility and acceptability of digital training programs. Preliminary effectiveness was explored as changes in competency outcomes, assessed using a self-reported measure covering the specific knowledge and skills required to deliver the brief psychological treatment for depression. Outcomes were collected at pre-training and post-training. Results : Of 42 non-specialist health workers randomized to the training programs, 36 including 10 (72%) in face-to-face, 12 (86%) in DGT, and 14 (100%) in DGT+ arms started the training. Among these participants, 27 (64%) completed the training, with 8 (57%) in face-to-face, 8 (57%) in DGT, and 11 (79%) in DGT+. The addition of remote telephone support appeared to improve completion rates for DGT+ participants. The competency outcome improved across all groups, with no significant between-group differences. However, face-to-face and DGT+ participants showed greater improvement compared to DGT alone. There were numerous technical challenges with the digital training program such as poor connectivity, smartphone app not loading, and difficulty navigating the course content-issues that were further emphasized in follow-up focus group discussions with participants. Feedback and recommendations collected from participants informed further modifications and refinements to the training programs in preparation for a forthcoming large-scale effectiveness trial. Conclusions : This study adds to mounting efforts aimed at leveraging digital technology to increase the availability of evidence-based mental health services in primary care settings in low-resource settings.",2020,This study adds to mounting efforts aimed at leveraging digital technology to increase the availability of evidence-based mental health services in primary care settings in low-resource settings.,"['Methods : Participants were non-specialist health workers recruited from primary care facilities in Sehore, a rural district in Madhya Pradesh, India', '42 non-specialist health workers randomized to the training programs, 36 including 10 (72%) in face-to-face, 12 (86%) in DGT, and 14 (100%) in DGT+ arms']","['digital program', 'Digital Training', 'digital training alone (DGT) to digital training with remote support (DGT+), and conventional face-to-face training']","['completion rates', 'feasibility and acceptability of digital training programs']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",,0.0363138,This study adds to mounting efforts aimed at leveraging digital technology to increase the availability of evidence-based mental health services in primary care settings in low-resource settings.,"[{'ForeName': 'Shital S', 'Initials': 'SS', 'LastName': 'Muke', 'Affiliation': 'Sangath, 120 Deepak Society, Chuna Bhatti, Kolar Road, Bhopal 462016, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Tugnawat', 'Affiliation': 'Sangath, 120 Deepak Society, Chuna Bhatti, Kolar Road, Bhopal 462016, India.'}, {'ForeName': 'Udita', 'Initials': 'U', 'LastName': 'Joshi', 'Affiliation': 'Sangath, 120 Deepak Society, Chuna Bhatti, Kolar Road, Bhopal 462016, India.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Sangath, 120 Deepak Society, Chuna Bhatti, Kolar Road, Bhopal 462016, India.'}, {'ForeName': 'Azaz', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Sangath, 120 Deepak Society, Chuna Bhatti, Kolar Road, Bhopal 462016, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Shrivastava', 'Affiliation': 'Sangath, 120 Deepak Society, Chuna Bhatti, Kolar Road, Bhopal 462016, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Sangath, 120 Deepak Society, Chuna Bhatti, Kolar Road, Bhopal 462016, India.'}, {'ForeName': 'Juliana L', 'Initials': 'JL', 'LastName': 'Restivo', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Bhan', 'Affiliation': 'Sangath, 120 Deepak Society, Chuna Bhatti, Kolar Road, Bhopal 462016, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Naslund', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA 02115, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17176368']
2657,32885585,Randomized controlled open-label study of the effect of vitamin E supplementation on fertility in clomiphene citrate-resistant polycystic ovary syndrome.,"AIM
To evaluate the effect of vitamin E on ovulation and pregnancy in women with clomiphene citrate (CC)-resistant polycystic ovary syndrome (PCOS).
METHODS
A prospective, randomized, controlled, open label study was conducted on women with CC-resistant PCOS. Patients were randomized, to either control group (n = 30), who received metformin 500 mg thrice daily, in addition to 150 mg/day CC for 5 days starting from day 3 of menstruation for three menstruation cycles, or vitamin E group (n = 30) who received vitamin E 1500 IU/day for the whole study period in addition to metformin and CC with the same previous regimen. The primary outcome was cumulative ovulation rate, while secondary outcomes were pregnancy rate, serum midluteal progesterone, mean follicular diameter, number of dominant follicles and endometrial thickness.
RESULTS
Ovulation was reported in 57 (64.8%) of 88 cycles in the control group and 63 (73.3%) of 86 cycles in the vitamin E group (P = 0.227), while pregnancy was reported in 4 (4.5%) of 88 cycles in the control group and 6 (7%) of 86 cycles in the vitamin E group (P = 0.491).There were nonsignificant differences between groups regarding serum midluteal progesterone, number of dominant follicles and mean follicular diameter. Endometrial thickness was significantly higher in the vitamin E group compared to the control group.
CONCLUSION
The findings of this trial do not support the hypothesis that vitamin E may increase the ovulation and pregnancy rates in women with clomiphene citrate-resistant PCOS.",2020,"RESULTS
Ovulation was reported in 57 (64.8%) of 88 cycles in the control group and 63 (73.3%) of 86 cycles in the vitamin E group (P = 0.227), while pregnancy was reported in 4 (4.5%) of 88 cycles in the control group and 6 (7%) of 86 cycles in the vitamin E group (P = 0.491).There were nonsignificant differences between groups regarding serum midluteal progesterone, number of dominant follicles and mean follicular diameter.","['women with CC-resistant PCOS', 'clomiphene citrate-resistant polycystic ovary syndrome', 'women with clomiphene citrate-resistant PCOS', 'women with clomiphene citrate (CC)-resistant polycystic ovary syndrome (PCOS']","['metformin 500\u2009mg thrice daily, in addition to 150\u2009mg/day CC', 'metformin and CC', 'vitamin E', 'vitamin E supplementation']","['fertility', 'ovulation and pregnancy rates', 'serum midluteal progesterone, number of dominant follicles and mean follicular diameter', 'cumulative ovulation rate', 'Endometrial thickness', 'ovulation and pregnancy', 'pregnancy rate, serum midluteal progesterone, mean follicular diameter, number of dominant follicles and endometrial thickness', 'Ovulation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C4524012', 'cui_str': 'Vitamin E supplementation'}]","[{'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",,0.171033,"RESULTS
Ovulation was reported in 57 (64.8%) of 88 cycles in the control group and 63 (73.3%) of 86 cycles in the vitamin E group (P = 0.227), while pregnancy was reported in 4 (4.5%) of 88 cycles in the control group and 6 (7%) of 86 cycles in the vitamin E group (P = 0.491).There were nonsignificant differences between groups regarding serum midluteal progesterone, number of dominant follicles and mean follicular diameter.","[{'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Morsy', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Misr University for Science and Technology, Giza, Egypt.'}, {'ForeName': 'Nagwa A', 'Initials': 'NA', 'LastName': 'Sabri', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Abdelrehim M', 'Initials': 'AM', 'LastName': 'Mourad', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Misr University for Science and Technology, Giza, Egypt.'}, {'ForeName': 'Eman M', 'Initials': 'EM', 'LastName': 'Mojahed', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Fayoum University, Fayoum, Egypt.'}, {'ForeName': 'May A', 'Initials': 'MA', 'LastName': 'Shawki', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14467']
2658,32887411,Effect of a Combined Program of Strength and Dual Cognitive-Motor Tasks in Multiple Sclerosis Subjects.,"This study investigated the effects of a 24-week combined training program (CTP) based on strength exercises and cognitive-motor tasks performed concurrently in participants with multiple sclerosis. A randomized, controlled intervention study was carried out. In total, 31 subjects with a confirmed diagnosis of multiple sclerosis (14 men and 17 women) were stratified and randomized into an intervention group (17 subjects) and a control group (14 subjects). The intervention group completed three weekly training sessions for 24 weeks, while the control group pursued their normal daily activities. In this program, cognitive-motor tasks were completed at once (dual tasking). A 3D photogrammetry connected to a selective attention system designed for dual tasking while walking was used. Ground reaction forces were measured using two force plates, one for sit-to-stand testing, while the other was used for static force measurement. Postural equilibrium was examined using a stabilometric plate based for Romberg test assessment. The 24-week training program for multiple sclerosis patients improved their static peak force by 11% ( p < 0 .05), their rate of force development by 36% ( p < 0.05), and their balance ( p < 0.05). Performance in daily activities such as walking or sitting-to-standing improved significantly in multiple sclerosis participants. CTP training was effective in reducing the dual-task costs of step length (48%) and walking velocity (54%), as compared to a matched control group.",2020,"The 24-week training program for multiple sclerosis patients improved their static peak force by 11% ( p < 0 .05), their rate of force development by 36% ( p < 0.05), and their balance ( p < 0.05).","['multiple sclerosis participants', '31 subjects with a confirmed diagnosis of multiple sclerosis (14 men and 17 women', 'Multiple Sclerosis Subjects', 'participants with multiple sclerosis']","['Combined Program of Strength and Dual Cognitive-Motor Tasks', 'combined training program (CTP', 'CTP training']","['Performance in daily activities such as walking or sitting-to-standing', 'static peak force', 'dual-task costs of step length', 'walking velocity', 'rate of force development']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",31.0,0.0141606,"The 24-week training program for multiple sclerosis patients improved their static peak force by 11% ( p < 0 .05), their rate of force development by 36% ( p < 0.05), and their balance ( p < 0.05).","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Gutiérrez-Cruz', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'Rojas-Ruiz', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'De la Cruz-Márquez', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Gutiérrez-Dávila', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, 18071 Granada, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17176397']
2659,32887521,Using Social Network Sites to Boost Savoring: Positive Effects on Positive Emotions.,"Research has demonstrated that positive interventions (PIs) can be effective in enhancing well-being. Our study used Facebook to conduct a PI based on savoring. Sixty-one university students in Taiwan were randomly assigned to undergo a three-week savoring PI, and 61 participants were assigned to a no-treatment control group. The results showed significantly enhanced positive affect in the treatment group compared to the control group, in both a post-test and a final follow-up, but no significant differences between the two groups in negative affect. The treatment group also displayed significantly lower depression in the post-test, which was not maintained at the follow-up. These results indicate that, for university students, a savoring intervention via Facebook can be an effective way of enhancing positive emotions.",2020,"The results showed significantly enhanced positive affect in the treatment group compared to the control group, in both a post-test and a final follow-up, but no significant differences between the two groups in negative affect.","['university students', 'Sixty-one university students in Taiwan']",[],"['lower depression', 'Positive Emotions']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",61.0,0.0165675,"The results showed significantly enhanced positive affect in the treatment group compared to the control group, in both a post-test and a final follow-up, but no significant differences between the two groups in negative affect.","[{'ForeName': 'Sen-Chi', 'Initials': 'SC', 'LastName': 'Yu', 'Affiliation': 'Department of Counseling and Applied Psychology, National Taichung University of Education, West District, Taichung City 403, Taiwan.'}, {'ForeName': 'Kennon M', 'Initials': 'KM', 'LastName': 'Sheldon', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO 65211, USA.'}, {'ForeName': 'Wen-Ping', 'Initials': 'WP', 'LastName': 'Lan', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO 65211, USA.'}, {'ForeName': 'Jia-Huei', 'Initials': 'JH', 'LastName': 'Chen', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO 65211, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17176407']
2660,32889135,Acupuncture and Dry Needling in the Reduction of Peripheral Acute Fatigue Induced in the Biceps Braquii: Protocol for a Single-blinded Randomized Controlled Clinical Trial.,"The present study aims to propose a protocol to verify the efficacy and acute effects of traditional Chinese acupuncture, dry needling, and the rest in peripheral acute fatigue (PAF) induced by intermittent isometric contractions of the nondominant biceps brachii (BB) of nonphysically active men in a randomized, single-blind clinical trial assessed with surface electromyography, contraction time in seconds, infrared thermal imaging, and visual analog scale applied to the PAF. These instruments will evaluate the median frequency, endurance time, temperature (°C), and perceived fatigue in BB of the volunteers. The measurements will be collected in four moments (Test 0, 01, 02, and 03) divided between the beginning and the end of two sets of exercises (Exercises 01 and 02) of intermittent isometric contractions. TRIAL IDENTIFIER: NCT03448120 in www.clinicaltrials.gov.",2020,"These instruments will evaluate the median frequency, endurance time, temperature (ºC), and perceived fatigue in BB of the volunteers.",['peripheral acute fatigue (PAF) induced by intermittent isometric contractions of the non-dominant biceps brachii (BB) of non-physically active men'],"['traditional Chinese acupuncture, dry needling and rest', 'Acupuncture and dry needling']","['peripheral acute fatigue', 'median frequency, endurance time, temperature (ºC), and perceived fatigue']","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.176669,"These instruments will evaluate the median frequency, endurance time, temperature (ºC), and perceived fatigue in BB of the volunteers.","[{'ForeName': 'Gabriel Barreto', 'Initials': 'GB', 'LastName': 'Antonino', 'Affiliation': 'Graduate Program of Neuropsychiatry and Behavioral Sciences of the Universidade Federal de Pernambuco, PE, Brazil. Electronic address: gabrielbarreto@live.com.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Paula de Lima Ferreira', 'Affiliation': 'Graduate Program of Physiotherapy of the Universidade Federal de Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Eduardo José', 'Initials': 'EJ', 'LastName': 'Nepomuceno Montenegro', 'Affiliation': 'Undergraduate Program of Physiotherapy of the Universidade Federal de Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Galvão de Moura Filho', 'Affiliation': 'Graduate Program of Physiotherapy of the Universidade Federal de Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Arthur Felipe', 'Initials': 'AF', 'LastName': 'Freire da Silva', 'Affiliation': 'Undergraduate Program of Physiotherapy of the Universidade Federal de Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Maria das Graças Rodrigues', 'Initials': 'MDGR', 'LastName': 'de Araújo', 'Affiliation': 'Graduate Program of Physiotherapy of the Universidade Federal de Pernambuco, Recife, PE, Brazil.'}]",Journal of acupuncture and meridian studies,['10.1016/j.jams.2020.08.001']
2661,32854563,Use of alcohol containing caps for preventing bloodstream infections: A randomized controlled trial.,"BACKGROUND
A majority of bloodstream infections seen in intensive care units stem from intravascular catheters used on patients. Catheter hubs are the entrance for pathogenic microorganisms into the inner surfaces of the catheters. The pathogenic microorganisms colonization in the mentioned areas can cause central line-associated bloodstream infection (CLABSI).
METHODS
This study was conducted as a randomized controlled trial to investigate the effect of alcohol-containing caps on the prevention of CLABSI. Total of 95 patients participated in the study. Isopropyl alcohol-containing caps were used for protecting the needle-free connectors closing the hubs of the central venous catheters in the intervention group. However, the control group patient received standard catheter caps.
RESULT
There was a statistically significant difference between groups in terms of infection distribution (X2 = 13.058; p < 0.001). The risk of infection in the control group was 13.7 times higher than the risk of infection in the intervention group.
DISCUSSION
Our results suggest that alcohol-containing caps are effective or in preventing CLABSI.
CONCLUSION
These findings suggest that alcohol-containing caps on ports are effective in preventing CLABSI.",2020,"The risk of infection in the control group was 13.7 times higher than the risk of infection in the intervention group.
",['Total of 95 patients participated in the study'],"['standard catheter caps', 'Isopropyl alcohol-containing caps', 'alcohol-containing caps', 'alcohol containing caps']","['risk of infection', 'bloodstream infections', 'infection distribution']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0022237', 'cui_str': 'Isopropyl Alcohol'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",95.0,0.0305145,"The risk of infection in the control group was 13.7 times higher than the risk of infection in the intervention group.
","[{'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Taşdelen Öğülmen', 'Affiliation': 'Infection Control Nurse, Kartal Koşuyolu High Speciality Educational And Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Sebahat', 'Initials': 'S', 'LastName': 'Ateş', 'Affiliation': 'School of Nursing, Maltepe Üniversity, İstanbul, Turkey.'}]",The journal of vascular access,['10.1177/1129729820952961']
2662,32856605,Asian Race and Risk of Prostate Cancer: Results from the REDUCE Study.,"BACKGROUND
Global prostate cancer incidence rates are lower in Asian men than Caucasian men. Whether this is the result of less screening in Asian men remains to be determined. We examined whether Asian race was associated with prostate cancer diagnosis in the Reduction by Dutasteride of Cancer Events (REDUCE) study.
METHODS
REDUCE was a 4-year, multicenter, randomized trial of dutasteride versus placebo for prostate cancer prevention among men who underwent prostate-specific antigen (PSA)-independent biopsies at 2 and 4 years. Eligible men were ages 50 to 75 years, had PSA between 2.5 and 10 ng/mL, and a negative prestudy prostate biopsy. We tested the association between Asian and Caucasian race and prostate cancer diagnosis using logistic regression.
RESULTS
Of 8,122 men in REDUCE, 5,755 (71%) were Caucasian and 105 (1.8%) were Asian. Asians had lower body mass index (24.8 vs. 26.9 kg/m 2 , P < 0.001), had smaller prostate volume (35.0 vs. 43.5 cc, P < 0.001), and were less likely to have abnormal digital rectal exams ( P = 0.048), but were similar in baseline age, PSA, family history of prostate cancer, and smoking status compared with Caucasian men (all P ≥ 0.164). Asian men were equally likely to receive any on-study biopsy compared with Caucasian men ( P = 0.634). After adjusting for potential confounders, Asian men were less likely to be diagnosed with prostate cancer during the 4-year study (OR = 0.49; 95% confidence interval, 0.28-0.88; P = 0.016), compared with Caucasian men.
CONCLUSIONS
In REDUCE, where all men underwent biopsies largely independent of PSA, Asian race was associated with lower prostate cancer diagnosis.
IMPACT
These findings suggest that lower prostate cancer risk in Asian men may be due to biological, genetic, and/or lifestyle factors.",2020,Asian men were equally likely to receive any on-study biopsy compared to Caucasian men (p=0.634).,"['Eligible men were aged 50-75 years, had PSA between 2.5-10 ng/mL, and a negative pre-study prostate biopsy', 'Of 8,122 men in REDUCE, 5,755 (71%) were Caucasian and 105 (1.8%) were Asian', 'men who underwent PSA-independent biopsies at 2- and 4-years', 'Asian race and risk of prostate cancer', 'Asian men than Caucasian men', 'Asian men']",['dutasteride vs. placebo'],"['abnormal digital rectal exam', 'body mass index', 'smaller prostate volume']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0199900', 'cui_str': 'Rectal examination'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0426733', 'cui_str': 'Small prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0674668,Asian men were equally likely to receive any on-study biopsy compared to Caucasian men (p=0.634).,"[{'ForeName': 'Adriana C', 'Initials': 'AC', 'LastName': 'Vidal', 'Affiliation': 'Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Center for Integrated Research on Cancer and Lifestyle, Los Angeles, California. adriana.vidal@cshs.org.'}, {'ForeName': 'Taofik', 'Initials': 'T', 'LastName': 'Oyekunle', 'Affiliation': 'Surgery Section, Durham VA Medical Center, Durham, North Carolina.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Feng', 'Affiliation': 'Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Center for Integrated Research on Cancer and Lifestyle, Los Angeles, California.'}, {'ForeName': 'Alexis R', 'Initials': 'AR', 'LastName': 'Freedland', 'Affiliation': 'Department of Epidemiology, UCI School of Medicine, University of California at Irvine, Irvine, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Moreira', 'Affiliation': 'Department of Urology, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Ramiro', 'Initials': 'R', 'LastName': 'Castro-Santamaria', 'Affiliation': 'Ohana Biosciences, Cambridge, Massachusetts.'}, {'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'Andriole', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Freedland', 'Affiliation': 'Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Center for Integrated Research on Cancer and Lifestyle, Los Angeles, California.'}, {'ForeName': 'Emma H', 'Initials': 'EH', 'LastName': 'Allott', 'Affiliation': ""Patrick G Johnston Centre for Cancer Research, Queen's University Belfast, Belfast, Northern Ireland, United Kingdom.""}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-20-0646']
2663,32858227,"The impact of Geriatric Emergency Department Innovations (GEDI) on health services use, health related quality of life, and costs: Protocol for a randomized controlled trial.","BACKGROUND AND OBJECTIVES
Older adults (age 65 and older) use the emergency department (ED) at a rate of nearly 50 ED visits per 100 older adults, accounting for over 23 million ED visits in the US annually, up to 20% of all ED visits. These ED visits are sentinel health events as discharged patients often return to the ED, experience declines in health-related quality of life (HRQoL) and disability, or are later hospitalized. Those who are admitted incur increased costs and greater risk for poor outcomes including infections, delirium, and falls. The objective of this randomized controlled trial (RCT) is to evaluate the efficacy of the Geriatric Emergency Department Innovations (GEDI) program, an ED nurse-led geriatric assessment and care coordination program, in decreasing unnecessary health services use and improving Health-Related Quality-of-Life (HRQoL) for older adults in the ED.
METHODS
Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420). Outcome variables will be assessed during the ED visit and at 7-11 days and 28-32 days post ED visit.
PROJECTED OUTCOMES
The primary outcome is hospitalization or death within 30 days of the ED visit. Secondary outcomes include health service use outcomes (ED visits and hospitalizations), healthcare costs, and HRQoL outcomes [Patient-Reported Outcomes Measurement Information System (PROMIS) scores: PROMIS-Preference, Physical Function, Ability to Participate in Social Roles and Activities, Anxiety, and Depression].
TRIAL REGISTRATION
Clinicaltrials.Gov identifier NCT04115371.",2020,"METHODS
Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420).","['Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either', 'older adults in the ED', 'Older adults (age 65 and older) use the emergency department (ED) at a rate of nearly 50 ED visits per 100 older adults, accounting for over 23 million ED visits in the US annually, up to 20% of all ED visits']","['Geriatric Emergency Department Innovations (GEDI', 'GEDI (n\u202f=\u202f420) or to usual ED care']","['health service use outcomes (ED visits and hospitalizations), healthcare costs, and HRQoL outcomes [Patient-Reported Outcomes Measurement Information System (PROMIS) scores: PROMIS-Preference, Physical Function, Ability to Participate in Social Roles and Activities, Anxiety, and Depression', 'hospitalization or death within 30\u202fdays of the ED visit', 'infections, delirium, and falls', 'Health-Related Quality-of-Life (HRQoL']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0547043', 'cui_str': 'Up'}]","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C4517774', 'cui_str': '420'}]","[{'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.106207,"METHODS
Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420).","[{'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Dresden', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Buheler Center for Health Policy and Economics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. Electronic address: sdresden@nm.org.'}, {'ForeName': 'Alexander X', 'Initials': 'AX', 'LastName': 'Lo', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Lindquist', 'Affiliation': 'Department of Internal Medicine, Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Masha', 'Initials': 'M', 'LastName': 'Kocherginsky', 'Affiliation': 'Department of Preventive Medicine, Division of Biostatistics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lori Ann', 'Initials': 'LA', 'LastName': 'Post', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Buheler Center for Health Policy and Economics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Dustin D', 'Initials': 'DD', 'LastName': 'French', 'Affiliation': 'Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Ophthalmology, Feinberg School of Medicine, Northwestern University, USA; Department of Veterans Affairs Health Services Research and Development Service, Edward Hines, Jr. VA Hospital, Hines, IL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gray', 'Affiliation': 'Department of Preventive Medicine, Division of Biostatistics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Heinemann', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University and Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106125']
2664,32858791,"Effectiveness of Health-Led Cognitive Behavioral-Based Group Therapy on Pain, Functional Disability and Psychological Outcomes among Knee Osteoarthritis Patients in Malaysia.","BACKGROUND
Psychosocial interventions for patients with osteoarthritis (OA) of the knee to reduce pain and improve physical and psychological functioning are still lacking in Malaysia.
METHODS
A parallel-group unblinded randomized controlled trial involving 300 patients was conducted in two hospital orthopedics clinics in Malaysia. Patients were randomly assigned to receive cognitive behavioral-based group therapy ( n = 150) or no further intervention ( n = 150). The primary outcome was the change from baseline in knee pain as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) at 6 months. The data collected were analyzed by covariate-adjusted mixed design repeated measures analysis of variance. All analyses were performed under the terms of intention-to-treat.
RESULTS
At 6 months, mean change from baseline in the KOOS knee pain score was 0.6 points (95% CI -1.73 to 2.94) in the control group and 8.9 points (95% CI 6.62 to 11.23) (denoting less knee pain intensity) in the intervention group (significant treatment effect p < 0.0001). Patients treated with such an approach also experienced significant improvement in functional ability when performing activities of daily living and had improved ability to cope with depression, anxiety and pain catastrophizing.
CONCLUSION
The intervention module delivered by healthcare professionals had a sustained effect on knee OA pain and functionality over 6 months, thereby leading to an overall improvement in psychological well-being, thus benefitting most of the Malaysian knee OA patients.",2020,"Patients treated with such an approach also experienced significant improvement in functional ability when performing activities of daily living and had improved ability to cope with depression, anxiety and pain catastrophizing.
","['patients with osteoarthritis (OA', '300 patients was conducted in two hospital orthopedics clinics in Malaysia', 'Knee Osteoarthritis Patients in Malaysia']","['cognitive behavioral-based group therapy ( n = 150) or no further intervention', 'Health-Led Cognitive Behavioral-Based Group Therapy']","['knee OA pain and functionality', 'ability to cope with depression, anxiety and pain catastrophizing', 'knee pain intensity', 'Pain, Functional Disability and Psychological Outcomes', 'change from baseline in knee pain as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS', 'functional ability', 'KOOS knee pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3838700', 'cui_str': 'Orthopedic clinic'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424097', 'cui_str': 'Ability to cope'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",300.0,0.133232,"Patients treated with such an approach also experienced significant improvement in functional ability when performing activities of daily living and had improved ability to cope with depression, anxiety and pain catastrophizing.
","[{'ForeName': 'Chai Nien', 'Initials': 'CN', 'LastName': 'Foo', 'Affiliation': 'Department of Population Medicine, Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Kajang 43000, Malaysia.'}, {'ForeName': 'Manohar', 'Initials': 'M', 'LastName': 'Arumugam', 'Affiliation': 'Department of Orthopaedic, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Rampal', 'Initials': 'R', 'LastName': 'Lekhraj', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Munn-Sann', 'Initials': 'MS', 'LastName': 'Lye', 'Affiliation': 'Department of Population Medicine, Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Kajang 43000, Malaysia.'}, {'ForeName': 'Sherina', 'Initials': 'S', 'LastName': 'Mohd-Sidik', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Zubaidah', 'Initials': 'Z', 'LastName': 'Jamil Osman', 'Affiliation': 'Faculty of Allied Health Sciences, Cyberjaya University College of Medical Sciences, Cyberjaya 63000, Malaysia.'}]",International journal of environmental research and public health,['10.3390/ijerph17176179']
2665,32859522,Identifying ActiGraph non-wear time in pregnant women with overweight or obesity.,"OBJECTIVES
Non-wear time algorithms have not been validated in pregnant women with overweight/obesity (PW-OW/OB), potentially leading to misclassification of sedentary/activity data, and inaccurate estimates of how physical activity is associated with pregnancy outcomes. We examined: (1) validity/reliability of non-wear time algorithms in PW-OW/OB by comparing wear time from five algorithms to a self-report criterion and (2) whether these algorithms over- or underestimated sedentary behaviors.
DESIGN
PW-OW/OB (N = 19) from the Healthy Mom Zone randomized controlled trial wore an ActiGraph GT3x + for 7 consecutive days between 8-12 weeks gestation.
METHODS
Non-wear algorithms (i.e., consecutive strings of zero acceleration in 60-second epochs) were tested at 60, 90, 120, 150, and 180-min. The monitor registered sedentary minutes as activity counts 0-99. Women completed daily self-report logs to report wear time.
RESULTS
Intraclass correlation coefficients for each algorithm were 0.96-0.97; Bland-Altman plots revealed no bias; mean absolute percent errors were <10%. Compared to self-report (M = 829.5, SD = 62.1), equivalency testing revealed algorithm wear times (min/day) were equivalent: 60- (M = 816.4, SD = 58.4), 90- (M = 827.5, SD = 61.4), 120- (M = 830.8, SD = 65.2), 150- (M = 833.8, SD = 64.6) and 180-min (M = 837.4, SD = 65.4). Repeated measures ANOVA showed 60- and 90-min algorithms may underestimate sedentary minutes compared to 150- and 180-min algorithms.
CONCLUSIONS
The 60, 90, 120, 150, and 180-min algorithms are valid and reliable for estimating wear time in PW-OW/OB. However, implementing algorithms with a higher threshold for consecutive zero counts (i.e., ≥150-min) can avoid the risk of misclassifying sedentary data.",2020,"The 60, 90, 120, 150, and 180-min algorithms are valid and reliable for estimating wear time in PW-OW/OB.","['pregnant women with overweight or obesity', 'pregnant women with overweight/obesity (PW-OW/OB']",['ActiGraph GT3x'],['daily self-report logs to report wear time'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0416337,"The 60, 90, 120, 150, and 180-min algorithms are valid and reliable for estimating wear time in PW-OW/OB.","[{'ForeName': 'Krista S', 'Initials': 'KS', 'LastName': 'Leonard', 'Affiliation': 'Exercise Psychology Laboratory, Department of Kinesiology, The Pennsylvania State University, United States.'}, {'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Pauley', 'Affiliation': 'Exercise Psychology Laboratory, Department of Kinesiology, The Pennsylvania State University, United States.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Hohman', 'Affiliation': 'Department of Nutritional Sciences and Center for Childhood Obesity Research, The Pennsylvania State University, United States.'}, {'ForeName': 'Penghong', 'Initials': 'P', 'LastName': 'Guo', 'Affiliation': 'School for Engineering of Matter, Transport, and Energy, Arizona State University, United States.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Rivera', 'Affiliation': 'School for Engineering of Matter, Transport, and Energy, Arizona State University, United States.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'Department of Nutritional Sciences and Center for Childhood Obesity Research, The Pennsylvania State University, United States.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Buman', 'Affiliation': 'College of Health Solutions, Arizona State University, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Symons Downs', 'Affiliation': 'Exercise Psychology Laboratory, Department of Kinesiology, The Pennsylvania State University, United States; Department of OBGYN, College of Medicine, The Pennsylvania State University, United States. Electronic address: dsd11@psu.edu.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.08.003']
2666,32865145,Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty.,"PURPOSE
To evaluate the 3-year safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) in a Japanese population with femoropopliteal occlusive disease.
MATERIALS AND METHODS
The multicenter, prospective, IN.PACT SFA Japan randomized controlled trial ( ClinicalTrials.gov identifier NCT01947478) was an independently adjudicated study evaluating Japanese participants randomized 2:1 to DCB (n=68) or PTA (n=32). The effectiveness endpoint was primary patency through 36 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis (by duplex ultrasound). The effectiveness endpoint was evaluated using the Kaplan-Meier method; estimates are presented with the 95% confidence intervals (CIs). The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 36 months.
RESULTS
Primary patency by Kaplan-Meier estimate was higher in the DCB group (68.9%, 95% CI 57.5% to 80.2%) vs the PTA group (46.9%, 95% CI 29.6% to 64.2%) at 36 months (log-rank p=0.001). The CD-TLR rates were 14.9% (10/67) for the DCB group and 20.7% (6/29) for PTA (p=0.554). The safety composite endpoint occurred in 83.6% (56/67) of DCB participants and 75.9% (22/29) of PTA participants (p=0.402). All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group.
CONCLUSION
The final report of the IN.PACT SFA Japan trial showed that the IN.PACT Admiral DCB is safe and had durable outcomes through 3 years in Japanese participants with femoropopliteal occlusive disease.",2020,"All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group.
","['Japanese participants with femoropopliteal occlusive disease', 'Japanese participants randomized 2:1 to DCB (n=68) or PTA (n=32', 'Japanese population with femoropopliteal occlusive disease']","['Percutaneous Transluminal Angioplasty', 'IN.PACT Admiral DCB', 'MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA']","['CD-TLR rates', 'All-cause death', 'freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis (by duplex ultrasound', 'Kaplan-Meier estimate', 'safety composite endpoint', '3-year safety and effectiveness']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C4521767', 'cui_str': 'US Military Commissioned Officer O10'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0242845', 'cui_str': 'Duplex ultrasound'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.1316,"All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group.
","[{'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Soga', 'Affiliation': 'Kokura Memorial Hospital, Fukuoka, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Iida', 'Affiliation': 'Kansai Rosai Hospital, Hyogo, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Urasawa', 'Affiliation': 'ToKeidai Memorial Hospital, Hokkaido, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Shonan Kamakura General Hospital, Kanagawa, Japan.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jaff', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Medtronic, Santa Rosa, CA, USA.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Ookubo', 'Affiliation': 'Medtronic, Minato-ku, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Yokoi', 'Affiliation': 'Fukuoka Sanno Hospital, Fukuoka, Japan.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602820948240']
2667,32861841,Longitudinal trajectories of mood symptoms and global functioning in youth at high risk for bipolar disorder.,"BACKGROUND
Little is known about the longitudinal course of mood symptoms and functioning in youth who are at high risk for bipolar disorder (BD). Identifying distinct course trajectories and predictors of those trajectories may help refine treatment approaches.
METHODS
This study examined the longitudinal course of mood symptoms and functioning ratings in 126 youth at high risk for BD based on family history and early mood symptoms. Participants were enrolled in a randomized trial of family-focused therapy and followed longitudinally (mean 2.0 years, SD = 53.6 weeks).
RESULTS
Using latent class growth analyses (LCGA), we observed three mood trajectories. All youth started the study with active mood symptoms. Following the index mood episode, participants were classified as having a ""significantly improving course"" (n = 41, 32.5% of sample), a ""moderately symptomatic course"" (n = 21, 16.7%), or a ""predominantly symptomatic course"" (n = 64, 50.8%) at follow-up. More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness. LCGA also revealed three trajectories of global functioning that closely corresponded to symptom trajectories; however, fewer youth exhibited functional recovery than exhibited symptomatic recovery.
LIMITATIONS
Mood trajectories were assessed within the context of a treatment trial. Ratings of mood and functioning were based on retrospective recall.
CONCLUSIONS
This study suggests considerable heterogeneity in the course trajectories of youth at high risk for BD, with a significant proportion (32.5%) showing long-term remission of symptoms. Treatments that enhance psychosocial functioning may be just as important as those that ameliorate symptoms in youth at risk for BD.",2020,"More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness.","['126 youth at high risk for BD based on family history and early mood symptoms', 'youth at high risk for bipolar disorder', 'youth who are at high risk for bipolar disorder (BD']",['LCGA'],"['severe depression, anxiety, and suicidality']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0524716,"More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness.","[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Weintraub', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA. Electronic address: mjweintraub@mednet.ucla.edu.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Schneck', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Walshaw', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA.'}, {'ForeName': 'Kiki D', 'Initials': 'KD', 'LastName': 'Chang', 'Affiliation': 'Private Practice, Menlo Park, CA, USA.'}, {'ForeName': 'Aimee E', 'Initials': 'AE', 'LastName': 'Sullivan', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'School of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.018']
2668,32867226,South Indian Cuisine with Low Glycemic Index Ingredients Reduces Cardiovascular Risk Factors in Subjects with Type 2 Diabetes.,"Background : Inflammation is considered as a predictor of cardiovascular diseases in type 2 diabetes mellitus. No previous studies have investigated the effect of low glycemic index (LGI) recipes of South Indian cuisine on the risk factors of cardiovascular disease in patients with diabetes. Aim : The aim of this randomized controlled trial was to evaluate the improvement in cardiovascular risk factors and blood glucose control, in patients with type 2 diabetes, after intervention with recipes of Kerala cuisine, from locally available whole grain cereals, low in glycemic index. Method : This was a prospective and randomized controlled study that was conducted over a period of 24 weeks. A total of 80 participants were recruited from the Department of Endocrinology and Diabetes Outpatient in Kerala, South India. All 80 patients had type 2 diabetes, and were aged between 35 and 65 years. Participants were randomly assigned and advised to follow either a LGI diet plan ( n = 40) or their usual diet, which served as a control group ( n = 40). The advice was reinforced throughout the study period. Anthropometric, biochemical parameters which included glycemic and cardio-metabolic parameters were measured according to standard procedures. T-tests were conducted to compare the differences between intervention and control groups, and the Pearson correlation coefficient was used to evaluate associations between the variables. Results : There were significant differences ( p < 0.05) between the intervention and control groups with respect to weight, HbA1c, insulin, triglycerides, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), high sensitivity C-reactive protein (hs-CRP) and apolipoprotein B (ApoB). There was also a positive correlation between weight and blood glucose variables. ApoB was positively correlated with lipid profile and insulin levels. Conclusions : The long-term implementation of LGI diet of Kerala cuisine has been found to promote weight loss, enhance insulin sensitivity and reduce the cardiovascular risk.",2020,"There were significant differences ( p < 0.05) between the intervention and control groups with respect to weight, HbA1c, insulin, triglycerides, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), high sensitivity C-reactive protein (hs-CRP) and apolipoprotein B (ApoB).","['type 2 diabetes mellitus', 'Subjects with Type 2 Diabetes', '80 participants were recruited from the Department of Endocrinology and Diabetes Outpatient in Kerala, South India', 'patients with diabetes', 'patients with type 2 diabetes, after intervention with recipes of Kerala cuisine, from locally available whole grain cereals, low in glycemic index', 'All 80 patients had type 2 diabetes, and were aged between 35 and 65 years']","['Low Glycemic Index Ingredients', 'LGI diet plan ( n = 40) or their usual diet']","['cardiovascular risk factors and blood glucose control', 'weight, HbA1c, insulin, triglycerides, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), high sensitivity C-reactive protein (hs-CRP) and apolipoprotein B (ApoB', 'Cardiovascular Risk Factors', 'weight and blood glucose variables', 'lipid profile and insulin levels']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0443018', 'cui_str': 'Kerala'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4046096', 'cui_str': 'Whole Grain Cereals'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}]",80.0,0.0386707,"There were significant differences ( p < 0.05) between the intervention and control groups with respect to weight, HbA1c, insulin, triglycerides, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), high sensitivity C-reactive protein (hs-CRP) and apolipoprotein B (ApoB).","[{'ForeName': 'Nivedita', 'Initials': 'N', 'LastName': 'Pavithran', 'Affiliation': 'Department of Clinical Nutrition, Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham, Kochi, Kerala 682041, India.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Kumar', 'Affiliation': 'Department of Endocrinology, Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham, Kochi, Kerala 682041, India.'}, {'ForeName': 'Arun Somasekharan', 'Initials': 'AS', 'LastName': 'Menon', 'Affiliation': 'Department of Endocrinology, Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham, Kochi, Kerala 682041, India.'}, {'ForeName': 'Gopala Krishna', 'Initials': 'GK', 'LastName': 'Pillai', 'Affiliation': 'Department of General Medicine, Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham, Kochi, Kerala 682041, India.'}, {'ForeName': 'Karimassery Ramaiyer', 'Initials': 'KR', 'LastName': 'Sundaram', 'Affiliation': 'Department of Biostatistics, Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham, Kochi, Kerala 682041, India.'}, {'ForeName': 'Omorogieva', 'Initials': 'O', 'LastName': 'Ojo', 'Affiliation': 'School of Health Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, London SE9 2UG, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17176232']
2669,32866688,Improved neck posture and reduced neck muscle activity when using a novel camera based workstation for manual precision inspection tasks.,"PURPOSE
This study investigates the effects of the usage of a novel camera system compared to a conventional lens system for manual precision tasks. Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
METHODS
Camera and lens systems were compared by assessing the craniovertebral angle (CVA), electromyographic activity of the M.trapezius and perceived exertion. 16 healthy participants (n = 8 female, 24 ± 2 years; n = 8 male, 30 ± 5 years) performed manual precision tasks in a cross-over design using both systems in sitting and standing positions.
RESULTS
Analyses showed that using the camera system improved the CVA in sitting [28.4° (22.8°-33.9°) to 42.5° (38.9°-46.1°); p < 0.01] and decreased the M.trapezius activity in standing [13.1% (7.7%-18.6%) to 8.65% (5.49%-11.81%)]. Additionally, overall and neck specific perceived exertion decreased when using the camera system in standing.
CONCLUSIONS
The camera system may prevent neck pain in workers performing manual precision tasks in sitting and standing postures.",2021,"Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
","['16 healthy participants (n\xa0=\xa08 female, 24\xa0±\xa02 years; n\xa0=\xa08 male, 30\xa0±\xa05 years) performed']","['manual precision tasks in a cross-over design using both systems in sitting and standing positions', 'novel camera system']","['craniovertebral angle (CVA), electromyographic activity of the M.trapezius and perceived exertion', 'CVA in sitting', 'Improved neck posture and reduced neck muscle activity', 'M.trapezius activity', 'overall and neck specific perceived exertion']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0179533', 'cui_str': 'Camera'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",16.0,0.0296013,"Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gräf', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Mattes', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luedtke', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany; Department of Health Sciences, Academic Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Wollesen', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany; Department of Psychology and Neuroergonomics, Technical University of Berlin, Fasanenstraße 1, 10623, Berlin, Germany. Electronic address: bettina.wollesen@uni-hamburg.de.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103147']
2670,32876689,Effect of Hydrocortisone on 21-Day Mortality or Respiratory Support Among Critically Ill Patients With COVID-19: A Randomized Clinical Trial.,"Importance
Coronavirus disease 2019 (COVID-19) is associated with severe lung damage. Corticosteroids are a possible therapeutic option.
Objective
To determine the effect of hydrocortisone on treatment failure on day 21 in critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and acute respiratory failure.
Design, Setting, and Participants
Multicenter randomized double-blind sequential trial conducted in France, with interim analyses planned every 50 patients. Patients admitted to the intensive care unit (ICU) for COVID-19-related acute respiratory failure were enrolled from March 7 to June 1, 2020, with last follow-up on June 29, 2020. The study intended to enroll 290 patients but was stopped early following the recommendation of the data and safety monitoring board.
Interventions
Patients were randomized to receive low-dose hydrocortisone (n = 76) or placebo (n = 73).
Main Outcomes and Measures
The primary outcome, treatment failure on day 21, was defined as death or persistent dependency on mechanical ventilation or high-flow oxygen therapy. Prespecified secondary outcomes included the need for tracheal intubation (among patients not intubated at baseline); cumulative incidences (until day 21) of prone position sessions, extracorporeal membrane oxygenation, and inhaled nitric oxide; Pao2:Fio2 ratio measured daily from day 1 to day 7, then on days 14 and 21; and the proportion of patients with secondary infections during their ICU stay.
Results
The study was stopped after 149 patients (mean age, 62.2 years; 30.2% women; 81.2% mechanically ventilated) were enrolled. One hundred forty-eight patients (99.3%) completed the study, and there were 69 treatment failure events, including 11 deaths in the hydrocortisone group and 20 deaths in the placebo group. The primary outcome, treatment failure on day 21, occurred in 32 of 76 patients (42.1%) in the hydrocortisone group compared with 37 of 73 (50.7%) in the placebo group (difference of proportions, -8.6% [95.48% CI, -24.9% to 7.7%]; P = .29). Of the 4 prespecified secondary outcomes, none showed a significant difference. No serious adverse events were related to the study treatment.
Conclusions and Relevance
In this study of critically ill patients with COVID-19 and acute respiratory failure, low-dose hydrocortisone, compared with placebo, did not significantly reduce treatment failure (defined as death or persistent respiratory support) at day 21. However, the study was stopped early and likely was underpowered to find a statistically and clinically important difference in the primary outcome.
Trial Registration
ClinicalTrials.gov Identifier: NCT02517489.",2020,"The primary outcome, treatment failure on day 21, occurred in 32 of 76 patients (42.1%) in the hydrocortisone group compared with 37 of 73 (50.7%) in the placebo group (difference of proportions, -8.6% [95.48% CI, -24.9% to 7.7%]; P = .29).","['group and 20 deaths in the placebo group', '149 patients (mean age, 62.2 years; 30.2% women; 81.2% mechanically ventilated) were enrolled', 'critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and acute respiratory failure', 'France, with interim analyses planned every 50 patients', 'Patients admitted to the intensive care unit (ICU) for COVID-19-related acute respiratory failure were enrolled from March 7 to June 1, 2020, with last follow-up on June 29, 2020', '290 patients but was stopped early following the recommendation of the data and safety monitoring board', 'Critically Ill Patients With COVID-19', 'critically ill patients with COVID-19 and acute respiratory failure, low-dose']","['low-dose hydrocortisone', 'Corticosteroids', 'placebo', 'hydrocortisone', 'Hydrocortisone']","['21-Day Mortality or Respiratory Support', 'death or persistent dependency on mechanical ventilation or high-flow oxygen therapy', 'treatment failure', 'treatment failure on day 21', 'need for tracheal intubation (among patients not intubated at baseline); cumulative incidences (until day 21) of prone position sessions, extracorporeal membrane oxygenation, and inhaled nitric oxide; Pao2:Fio2 ratio measured daily', 'serious adverse events']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0949757', 'cui_str': 'Data and Safety Monitoring Boards'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445105', 'cui_str': 'Not intubated'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.710857,"The primary outcome, treatment failure on day 21, occurred in 32 of 76 patients (42.1%) in the hydrocortisone group compared with 37 of 73 (50.7%) in the placebo group (difference of proportions, -8.6% [95.48% CI, -24.9% to 7.7%]; P = .29).","[{'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Dequin', 'Affiliation': 'Médecine Intensive-Réanimation, CHU de Tours, Tours, France.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Heming', 'Affiliation': 'Médecine Intensive Réanimation, Hôpital Raymond Poincaré (GHU APHP Université Paris Saclay), Garches, France, and RHU RECORDS and FHU SEPSIS.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Meziani', 'Affiliation': 'Médecine Intensive Réanimation, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Plantefève', 'Affiliation': 'Réanimation polyvalente, CH Victor Dupouy, Argenteuil, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Voiriot', 'Affiliation': 'Médecine Intensive Réanimation, Hôpital Tenon (Assistance Publique-Hôpitaux de Paris), Paris, France.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Badié', 'Affiliation': 'Réanimation Polyvalente, Hôpital Nord Franche-Comté, Trevenans, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'François', 'Affiliation': 'Réanimation Polyvalente, CHU de Limoges, Limoges, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Aubron', 'Affiliation': 'Médecine Intensive Réanimation, CHRU de Brest, Brest, France.'}, {'ForeName': 'Jean-Damien', 'Initials': 'JD', 'LastName': 'Ricard', 'Affiliation': 'Université de Paris, IAME U1137, Médecine Intensive Réanimation, DMU ESPRIT, Hôpital Louis Mourier, Assistance Publique-Hôpitaux de Paris, Colombe, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': 'Médecine Intensive-Réanimation, CHU de Tours, Tours, France.'}, {'ForeName': 'Youenn', 'Initials': 'Y', 'LastName': 'Jouan', 'Affiliation': 'Médecine Intensive-Réanimation, CHU de Tours, Tours, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Guillon', 'Affiliation': 'Médecine Intensive-Réanimation, CHU de Tours, Tours, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Leclerc', 'Affiliation': ""Délégation à la Recherche Clinique et à l'Innovation, CHU de Tours, Tours, France.""}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Coffre', 'Affiliation': ""Délégation à la Recherche Clinique et à l'Innovation, CHU de Tours, Tours, France.""}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Bourgoin', 'Affiliation': 'Pharmacie à Usage Interne, CHU de Tours, Tours, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Lengellé', 'Affiliation': ""Centre régional de pharmacovigilance et d'information sur le médicament, service de pharmacosurveillance, CHU de Tours, Tours, France.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Caille-Fénérol', 'Affiliation': 'INSERM CIC 1435, CHU de Limoges, Limoges, France.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Tavernier', 'Affiliation': 'INSERM CIC1415, CHU de Tours, Tours, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Zohar', 'Affiliation': 'INSERM, Centre de Recherche des Cordeliers, Sorbonne Université, Université de Paris, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': 'INSERM CIC1415, CHU de Tours, Tours, France.'}, {'ForeName': 'Djillali', 'Initials': 'D', 'LastName': 'Annane', 'Affiliation': 'Médecine Intensive Réanimation, Hôpital Raymond Poincaré (GHU APHP Université Paris Saclay), Garches, France, and RHU RECORDS and FHU SEPSIS.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Le Gouge', 'Affiliation': 'INSERM CIC1415, CHU de Tours, Tours, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.16761']
2671,32876694,Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19: A Meta-analysis.,"Importance
Effective therapies for patients with coronavirus disease 2019 (COVID-19) are needed, and clinical trial data have demonstrated that low-dose dexamethasone reduced mortality in hospitalized patients with COVID-19 who required respiratory support.
Objective
To estimate the association between administration of corticosteroids compared with usual care or placebo and 28-day all-cause mortality.
Design, Setting, and Participants
Prospective meta-analysis that pooled data from 7 randomized clinical trials that evaluated the efficacy of corticosteroids in 1703 critically ill patients with COVID-19. The trials were conducted in 12 countries from February 26, 2020, to June 9, 2020, and the date of final follow-up was July 6, 2020. Pooled data were aggregated from the individual trials, overall, and in predefined subgroups. Risk of bias was assessed using the Cochrane Risk of Bias Assessment Tool. Inconsistency among trial results was assessed using the I2 statistic. The primary analysis was an inverse variance-weighted fixed-effect meta-analysis of overall mortality, with the association between the intervention and mortality quantified using odds ratios (ORs). Random-effects meta-analyses also were conducted (with the Paule-Mandel estimate of heterogeneity and the Hartung-Knapp adjustment) and an inverse variance-weighted fixed-effect analysis using risk ratios.
Exposures
Patients had been randomized to receive systemic dexamethasone, hydrocortisone, or methylprednisolone (678 patients) or to receive usual care or placebo (1025 patients).
Main Outcomes and Measures
The primary outcome measure was all-cause mortality at 28 days after randomization. A secondary outcome was investigator-defined serious adverse events.
Results
A total of 1703 patients (median age, 60 years [interquartile range, 52-68 years]; 488 [29%] women) were included in the analysis. Risk of bias was assessed as ""low"" for 6 of the 7 mortality results and as ""some concerns"" in 1 trial because of the randomization method. Five trials reported mortality at 28 days, 1 trial at 21 days, and 1 trial at 30 days. There were 222 deaths among the 678 patients randomized to corticosteroids and 425 deaths among the 1025 patients randomized to usual care or placebo (summary OR, 0.66 [95% CI, 0.53-0.82]; P < .001 based on a fixed-effect meta-analysis). There was little inconsistency between the trial results (I2 = 15.6%; P = .31 for heterogeneity) and the summary OR was 0.70 (95% CI, 0.48-1.01; P = .053) based on the random-effects meta-analysis. The fixed-effect summary OR for the association with mortality was 0.64 (95% CI, 0.50-0.82; P < .001) for dexamethasone compared with usual care or placebo (3 trials, 1282 patients, and 527 deaths), the OR was 0.69 (95% CI, 0.43-1.12; P = .13) for hydrocortisone (3 trials, 374 patients, and 94 deaths), and the OR was 0.91 (95% CI, 0.29-2.87; P = .87) for methylprednisolone (1 trial, 47 patients, and 26 deaths). Among the 6 trials that reported serious adverse events, 64 events occurred among 354 patients randomized to corticosteroids and 80 events occurred among 342 patients randomized to usual care or placebo.
Conclusions and Relevance
In this prospective meta-analysis of clinical trials of critically ill patients with COVID-19, administration of systemic corticosteroids, compared with usual care or placebo, was associated with lower 28-day all-cause mortality.",2020,"There was little inconsistency between the trial results (I2 = 15.6%; P = .31 for heterogeneity) and the summary OR was 0.70 (95% CI, 0.48-1.01; P = .053) based on the random-effects meta-analysis.","['patients with coronavirus disease 2019 (COVID-19', 'hospitalized patients with COVID-19 who required respiratory support', '12 countries from February 26, 2020, to June 9, 2020, and the date of final follow-up was July 6, 2020', '1703 patients (median age, 60 years [interquartile range, 52-68 years]; 488 [29%] women) were included in the analysis', 'critically ill patients with COVID-19, administration of systemic corticosteroids, compared with', '222 deaths among the 678 patients randomized to corticosteroids and 425 deaths among the 1025 patients randomized to', 'Critically Ill Patients With COVID-19', '1703 critically ill patients with COVID-19', '1025 patients']","['corticosteroids', 'systemic dexamethasone, hydrocortisone, or methylprednisolone (678 patients) or to receive usual care or placebo', 'methylprednisolone', 'usual care or placebo', 'dexamethasone', 'placebo', 'hydrocortisone']","['cause mortality', 'investigator-defined serious adverse events', 'mortality quantified using odds ratios (ORs', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3844105', 'cui_str': '425'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",1703.0,0.618646,"There was little inconsistency between the trial results (I2 = 15.6%; P = .31 for heterogeneity) and the summary OR was 0.70 (95% CI, 0.48-1.01; P = .053) based on the random-effects meta-analysis.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Jonathan A C', 'Initials': 'JAC', 'LastName': 'Sterne', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'Department of Pediatrics, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Janet V', 'Initials': 'JV', 'LastName': 'Diaz', 'Affiliation': 'Clinical Unit, Health Emergencies Programme, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Slutsky', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Villar', 'Affiliation': 'Research Unit, Hospital Universitario Dr Negrín, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Djillali', 'Initials': 'D', 'LastName': 'Annane', 'Affiliation': 'Department of Intensive Care, Raymond Poincaré Hospital (APHP), School of Medicine Simone Veil, University Paris Saclay-UVSQ, Paris, France.'}, {'ForeName': 'Luciano Cesar Pontes', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'HCor Research Insitute, São Paulo, Brazil.'}, {'ForeName': 'Pierre-Francois', 'Initials': 'PF', 'LastName': 'Dequin', 'Affiliation': 'Médecine Intensive-Réanimation, INSERM CIC1415, CHRU de Tours, Tours, France.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Emberson', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fisher', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, Faculty of Population Health Sciences, University College London, London, England.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': 'CIC INSERM 1415-CHRU de Tours, Tours, France.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care, Imperial College London, London, England.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, England.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Heming', 'Affiliation': 'Department of Intensive Care, Raymond Poincaré Hospital (APHP), School of Medicine Simone Veil, University Paris Saclay-UVSQ, Paris, France.'}, {'ForeName': 'Julian P T', 'Initials': 'JPT', 'LastName': 'Higgins', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Horby', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, England.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, England.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Le Gouge', 'Affiliation': 'CIC INSERM 1415-CHRU de Tours, Tours, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Leclerc', 'Affiliation': 'CIC INSERM 1415-CHRU de Tours, Tours, France.'}, {'ForeName': 'Wei Shen', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': 'Respiratory Medicine Department, Nottingham University Hospitals NHS Trust, Nottingham, England.'}, {'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Anesthesiology, Pain, and Intensive Care Department, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Meziani', 'Affiliation': 'Hôpitaux Universitaires de Strasbourg, Service de Médecine Intensive Réanimation, Nouvel Hôpital Civil, Strasbourg, France.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marie Warrer', 'Initials': 'MW', 'LastName': 'Petersen', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Savovic', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Tomazini', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Viviane C', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'BP-A Beneficência Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Webb', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Marshall', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}]",JAMA,['10.1001/jama.2020.17023']
2672,32876695,Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19: The CoDEX Randomized Clinical Trial.,"Importance
Acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) is associated with substantial mortality and use of health care resources. Dexamethasone use might attenuate lung injury in these patients.
Objective
To determine whether intravenous dexamethasone increases the number of ventilator-free days among patients with COVID-19-associated ARDS.
Design, Setting, and Participants
Multicenter, randomized, open-label, clinical trial conducted in 41 intensive care units (ICUs) in Brazil. Patients with COVID-19 and moderate to severe ARDS, according to the Berlin definition, were enrolled from April 17 to June 23, 2020. Final follow-up was completed on July 21, 2020. The trial was stopped early following publication of a related study before reaching the planned sample size of 350 patients.
Interventions
Twenty mg of dexamethasone intravenously daily for 5 days, 10 mg of dexamethasone daily for 5 days or until ICU discharge, plus standard care (n =151) or standard care alone (n = 148).
Main Outcomes and Measures
The primary outcome was ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation. Secondary outcomes were all-cause mortality at 28 days, clinical status of patients at day 15 using a 6-point ordinal scale (ranging from 1, not hospitalized to 6, death), ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, and Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) at 48 hours, 72 hours, and 7 days.
Results
A total of 299 patients (mean [SD] age, 61 [14] years; 37% women) were enrolled and all completed follow-up. Patients randomized to the dexamethasone group had a mean 6.6 ventilator-free days (95% CI, 5.0-8.2) during the first 28 days vs 4.0 ventilator-free days (95% CI, 2.9-5.4) in the standard care group (difference, 2.26; 95% CI, 0.2-4.38; P = .04). At 7 days, patients in the dexamethasone group had a mean SOFA score of 6.1 (95% CI, 5.5-6.7) vs 7.5 (95% CI, 6.9-8.1) in the standard care group (difference, -1.16; 95% CI, -1.94 to -0.38; P = .004). There was no significant difference in the prespecified secondary outcomes of all-cause mortality at 28 days, ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, or the 6-point ordinal scale at 15 days. Thirty-three patients (21.9%) in the dexamethasone group vs 43 (29.1%) in the standard care group experienced secondary infections, 47 (31.1%) vs 42 (28.3%) needed insulin for glucose control, and 5 (3.3%) vs 9 (6.1%) experienced other serious adverse events.
Conclusions and Relevance
Among patients with COVID-19 and moderate or severe ARDS, use of intravenous dexamethasone plus standard care compared with standard care alone resulted in a statistically significant increase in the number of ventilator-free days (days alive and free of mechanical ventilation) over 28 days.
Trial Registration
ClinicalTrials.gov Identifier: NCT04327401.",2020,"At 7 days, patients in the dexamethasone group had a mean SOFA score of 6.1 (95% CI, 5.5-6.7) vs 7.5 (95% CI, 6.9-8.1) in the standard care group (difference, -1.16; 95% CI, -1.94 to -0.38; P = .004).","['41 intensive care units (ICUs) in Brazil', 'patients with COVID-19 and moderate or severe ARDS', 'Patients with COVID-19 and moderate to severe ARDS, according to the Berlin definition, were enrolled from April 17 to June 23, 2020', 'Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19', '350 patients', '299 patients (mean [SD] age, 61 [14] years; 37% women', 'patients with COVID-19-associated ARDS']","['dexamethasone', 'Dexamethasone', 'standard care alone']","['cause mortality at 28 days, clinical status of patients at day 15 using a 6-point ordinal scale (ranging from 1, not hospitalized to 6, death), ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, and Sequential Organ Failure Assessment (SOFA) scores', 'mechanical ventilation duration', 'ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation', 'number of ventilator-free days', 'number of ventilator-free days (days alive and free of mechanical ventilation', 'Days Alive and Ventilator-Free', 'mean SOFA score', 'secondary infections', 'serious adverse events']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0442886', 'cui_str': 'Secondary infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",299.0,0.228585,"At 7 days, patients in the dexamethasone group had a mean SOFA score of 6.1 (95% CI, 5.5-6.7) vs 7.5 (95% CI, 6.9-8.1) in the standard care group (difference, -1.16; 95% CI, -1.94 to -0.38; P = .004).","[{'ForeName': 'Bruno M', 'Initials': 'BM', 'LastName': 'Tomazini', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Israel S', 'Initials': 'IS', 'LastName': 'Maia', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Regis G', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.'}, {'ForeName': 'Viviane C', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'International Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Flavia R', 'Initials': 'FR', 'LastName': 'Bueno', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Maria Vitoria A O', 'Initials': 'MVAO', 'LastName': 'Silva', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Franca P', 'Initials': 'FP', 'LastName': 'Baldassare', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Eduardo L V', 'Initials': 'ELV', 'LastName': 'Costa', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Ricardo A B', 'Initials': 'RAB', 'LastName': 'Moura', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Michele O', 'Initials': 'MO', 'LastName': 'Honorato', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Andre N', 'Initials': 'AN', 'LastName': 'Costa', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Lisboa', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Letícia', 'Initials': 'L', 'LastName': 'Kawano-Dourado', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Guilherme B', 'Initials': 'GB', 'LastName': 'Olivato', 'Affiliation': 'Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Cassia', 'Initials': 'C', 'LastName': 'Righy', 'Affiliation': 'Instituto Estadual do Cérebro Paulo Niemeyer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Cristina P', 'Initials': 'CP', 'LastName': 'Amendola', 'Affiliation': 'Barretos Cancer Hospital, Barretos, Brazil.'}, {'ForeName': 'Roberta M L', 'Initials': 'RML', 'LastName': 'Roepke', 'Affiliation': 'Departamento de Cirurgia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela H M', 'Initials': 'DHM', 'LastName': 'Freitas', 'Affiliation': 'UTI Respiratória, Instituto do Coração (Incor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniel N', 'Initials': 'DN', 'LastName': 'Forte', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Flávio G R', 'Initials': 'FGR', 'LastName': 'Freitas', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.'}, {'ForeName': 'Caio C F', 'Initials': 'CCF', 'LastName': 'Fernandes', 'Affiliation': 'Hospital Mario Covas, FMABC, Santo Andre, Brazil.'}, {'ForeName': 'Livia M G', 'Initials': 'LMG', 'LastName': 'Melro', 'Affiliation': 'Hospital Samaritano Paulista, São Paulo, Brazil.'}, {'ForeName': 'Gedealvares F S', 'Initials': 'GFS', 'LastName': 'Junior', 'Affiliation': 'Hospital Evangélico de Vila Velha, Vila Velha, Brazil.'}, {'ForeName': 'Douglas Costa', 'Initials': 'DC', 'LastName': 'Morais', 'Affiliation': 'Aché Laboratórios Farmacêuticos, São Paulo, Brazil.'}, {'ForeName': 'Stevin', 'Initials': 'S', 'LastName': 'Zung', 'Affiliation': 'Aché Laboratórios Farmacêuticos, São Paulo, Brazil.'}, {'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.'}, {'ForeName': 'Luciano C P', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.17021']
2673,32873131,Combining the Passeo-18 Lux Drug-Coated Balloon and the Pulsar-18 Bare Metal Stent: 12- and 24-Month Outcomes of the BIOLUX 4EVER Investigator-Initiated Trial.,"PURPOSE
To report the outcomes after treating stenotic or occluded femoropopliteal lesions with a drug-coated balloon (DCB) followed by the implantation of a thin-strut self-expanding bare metal stent in the BIOLUX 4EVER trial ( ClinicalTrials.gov identifier NCT02211664).
MATERIALS AND METHODS
The prospective, multicenter, physician-initiated BIOLUX 4-EVER trial was conducted at 5 centers in Belgium and enrolled 120 patients (mean age 70.9±10.5 years; 79 men) with symptomatic stenotic or occluded de novo femoropopliteal lesions. A fifth of the patients had diabetes mellitus and nearly half had previous peripheral artery interventions. The lesions were a mean 83.3±49.5 mm long with a mean reference vessel diameter of 5.26±0.59 mm. Lesions were treated with a Passeo-18 Lux DCB followed by the implantation of a Pulsar-18 bare metal stent. Follow-up visits were conducted at 1, 6, 12, and 24 months postprocedure; the main outcome was primary patency at 12 months.
RESULTS
Technical success was obtained in all patients. Primary patency was observed in 89.9% of patients (95% CI 84.0% to 95.8%) at 12 months and in 83.5% at 24 months (95% CI 89.9% to 97.3%), and freedom from target lesion revascularization was 93.6% (95% CI 89.9% to 97.3%) and 86.1% (95% CI 79.9% to 92.3%), respectively. Ten patients died throughout the course of the trial (90.7% survival at 24 months), all of noncardiovascular causes. The ankle-brachial index improved from 0.68±0.09 at baseline to 0.93±0.11 and 0.93±0.12 at 12- and 24-month follow-up visits (p<0.001). An improvement of at least 1 Rutherford category was observed in 91 of 94 patients (96.8%) at 12 months and 78 of 83 patients (93.4%) at 24 months (p<0.001).
CONCLUSION
The combination of a Passeo-18 Lux DCB followed by a Pulsar-18 stent implantation produced safe and effective outcomes in the treatment of femoropopliteal lesions at up to 24 months. Adding paclitaxel to the bare nitinol stent platform by predilating with a Passeo-18 Lux DCB seems to increase efficacy at 1 and 2 years compared with the use of bare metal stents only, which were investigated in the precursor 4-EVER study.",2020,"Primary patency was observed in 89.9% of patients (95% CI 84.0% to 95.8%) at 12 months and in 83.5% at 24 months (95% CI 89.9% to 97.3%), and freedom from target lesion revascularization was 93.6% (95% CI 89.9% to 97.3%) and 86.1% (95% CI 79.9% to 92.3%), respectively.","['5 centers in Belgium and enrolled 120 patients (mean age 70.9±10.5 years; 79 men) with symptomatic stenotic or occluded de novo femoropopliteal lesions', 'patients had diabetes mellitus and nearly half had previous peripheral artery interventions']","['paclitaxel', 'Passeo-18 Lux Drug-Coated Balloon and the Pulsar-18 Bare Metal Stent', 'Passeo-18 Lux DCB', 'drug-coated balloon (DCB']","['freedom from target lesion revascularization', 'Technical success', 'Primary patency', 'ankle-brachial index']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0333181', 'cui_str': 'Stenosed'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0024176', 'cui_str': 'Luxembourg'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0917885', 'cui_str': 'Pulsar'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}]",120.0,0.0787334,"Primary patency was observed in 89.9% of patients (95% CI 84.0% to 95.8%) at 12 months and in 83.5% at 24 months (95% CI 89.9% to 97.3%), and freedom from target lesion revascularization was 93.6% (95% CI 89.9% to 97.3%) and 86.1% (95% CI 79.9% to 92.3%), respectively.","[{'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Deloose', 'Affiliation': 'Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bosiers', 'Affiliation': 'Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Peeters', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Verbist', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.'}, {'ForeName': 'Lieven', 'Initials': 'L', 'LastName': 'Maene', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Beelen', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Keirse', 'Affiliation': 'Department of Vascular Surgery, R.Z. Heilig-Hart, Tienen, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Hendriks', 'Affiliation': 'Department Thoracic and Vascular Surgery, UZA, Edegem, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lauwers', 'Affiliation': 'Department Thoracic and Vascular Surgery, UZA, Edegem, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Wauters', 'Affiliation': 'Vascular Research Department, Dendermonde, Belgium.'}, {'ForeName': 'Merel', 'Initials': 'M', 'LastName': 'Verschueren', 'Affiliation': 'Vascular Research Department, Dendermonde, Belgium.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602820952413']
2674,32891607,Partial sleep deprivation affects endurance performance and psychophysiological responses during 12-minute self-paced running exercise.,"PURPOSE
This study aimed to investigate the effects of partial sleep deprivation (PSD) on physical performance and psychophysiological responses during 12-minute self-paced running exercise.
METHODS
Twenty runners (20.8±1.1 years, 70.6±4.9 kg, 175.1±3.9 cm) performed, in a randomized order, two running self-paced field exercises after a normal sleep night (CONT, bedtime from 22:30 h to 06:30 h) and one night of PSD (bedtime from 00:30 h to 04:30 h). Core temperature and motivation were recorded before exercise. Speed, covered distance, heart rate (HR), rating of perceived exertion (RPE) and respiratory parameters (i.e., minute ventilation (VE), oxygen uptake (VO 2 ) and carbon dioxide production (VCO 2 )) were assessed during exercise. Blood lactate concentration [La] was assessed 2 min after exercise. Simple reaction time (SRT), mood and barrage test (BT) were assessed before and after exercise.
RESULTS
Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=-6% for covered distance), following PSD, were obtained compared to CONT. Similarly, PSD attenuated core temperature (p=0.01, d=0.84), HR (p=0.006, ɳp 2 =0.45), VE (p=0.001, ɳp 2 =0.73), VO 2 (p=0.001, ɳp 2 =0.96), BT (p<0.0005, ɳp 2 =0.86), SRT (p=0.0009, ɳp 2 =0.44) and mood (p<0.0005). However, VCO 2 , [La] and motivation score were not affected by sleep conditions.
CONCLUSION
The decrease of running performance and the increase of physical discomfort after PSD could be the origin of the lower cardio-respiratory responses to the 12-minute self-paced exercise. Effective strategies should be introduced to overcome the deterioration of physical performance and physiological responses after PSD.",2020,"RESULTS
Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=","['Twenty runners (20.8±1.1 years, 70.6±4.9 kg, 175.1±3.9 cm']","['12-minute self-paced running exercise', 'Partial sleep deprivation', 'running self-paced field exercises after a normal sleep night (CONT, bedtime from 22:30 h to 06:30 h) and one night of PSD', 'partial sleep deprivation (PSD']","['PSD attenuated core temperature', 'running performance', 'SRT', 'VCO 2 , [La] and motivation score', 'physical performance and psychophysiological responses', 'endurance performance and psychophysiological responses', 'Blood lactate concentration [La', 'Simple reaction times (SRT), mood and barrage test (BT', 'Core temperature and motivation', 'Speed, covered distance, heart rate (HR), rating of perceived exertion (RPE) and respiratory parameters (i.e., minute ventilation (VE), oxygen uptake (VO 2 ) and carbon dioxide production (VCO 2 ', 'lower physical performance', 'physical discomfort']","[{'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",,0.0445421,"RESULTS
Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=","[{'ForeName': 'Wajdi', 'Initials': 'W', 'LastName': 'Souissi', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hammouda', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France; Research Laboratory, Molecular Bases of Human Pathology, LR19ES13, Faculty of Medicine, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ayachi', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Achraf', 'Initials': 'A', 'LastName': 'Ammar', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke University, Magdeburg, Germany.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khcharem', 'Affiliation': 'Research Laboratory, Education, Motricity, Sport and Health, UR15JS01, High Institute of Sport and Physical Education, University of Sfax, Tunisia; Laboratory of Pharmacology, Faculty of Medicine, University of Sfax, Tunisia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Marco', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Souissi', 'Affiliation': 'Research Laboratory, Education, Motricity, Sport and Health, UR15JS01, High Institute of Sport and Physical Education, University of Sfax, Tunisia.'}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Driss', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France. Electronic address: tarak.driss@parisnanterre.fr.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113165']
2675,32891678,The impact of shared decision making with patient decision aids on the rotavirus vaccination rate in children: A randomized controlled trial.,"Rotavirus vaccination reduces the incidence and severity of acute gastroenteritis due to rotavirus infection. However, because of a lack of understanding and private payment for the rotavirus vaccine, the rotavirus vaccination rate is still low in some countries. We intended to assess the impact of shared decision-making (SDM) with the assistance of patient decision aids (PDAs) on the rotavirus vaccination rate, and the knowledge, confidence, and congruence of value among baby's parents when decision-making. The study was a two-group, outcome assessor-blind, randomized, controlled trial. The families of 1-month-old infants for routine vaccination were enrolled; they were divided randomly into non-SDM and SDM groups. The influence of SDM on the acceptance of rotavirus vaccination was assessed when their infants were 2 months old. Outcome measures were decisional conflict, decision-making difficulties, and rotavirus vaccine knowledge, and the overall rotavirus vaccination rate. The study enrolled 180 participants. SDM, parents' education level, and rotavirus vaccination of a previous child were variables that influenced acceptance of rotavirus vaccination. The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus. The rotavirus vaccination rate was 16.7% higher in the SDM group than the non-SDM group. SDM assisted with PDAs gives more information and helps infants' families understand what they need, reduces their decision conflict, and increases their baby's vaccination against rotavirus, which promotes public health. The clinical trial is registered at ClinicalTrials.gov (NCT03804489).",2020,"The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus.","['children', '180 participants', 'families of 1-month-old infants for routine vaccination were enrolled']","['shared decision-making (SDM) with the assistance of patient decision aids (PDAs', 'Rotavirus vaccination', 'SDM', 'patient decision aids', 'SDM assisted with PDAs']","['acceptance of rotavirus vaccination', 'rotavirus vaccination rate', 'decisional conflict, decision-making difficulties, and rotavirus vaccine knowledge, and the overall rotavirus vaccination rate', 'rotavirus vaccination rate, and the knowledge, confidence, and congruence of value']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0857208', 'cui_str': 'Routine vaccination'}]","[{'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",180.0,0.124641,"The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus.","[{'ForeName': 'Sheng-Chieh', 'Initials': 'SC', 'LastName': 'Lin', 'Affiliation': 'Division of Allergy, Asthma, and Immunology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: jacklinmails@yahoo.com.tw.'}, {'ForeName': 'Ka-Wai', 'Initials': 'KW', 'LastName': 'Tam', 'Affiliation': 'Division of General Surgery, Department of Surgery, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Division of General Surgery, Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; Shared Decision Making Resource Center, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: kelvintam@h.tmu.edu.tw.'}, {'ForeName': 'Jean Yu-Chun', 'Initials': 'JY', 'LastName': 'Yen', 'Affiliation': 'Research Center of Biostatistics, College of Management, Taipei Medical University, Taipei, Taiwan. Electronic address: jeanycy@tmu.edu.tw.'}, {'ForeName': 'Meng-Che', 'Initials': 'MC', 'LastName': 'Lu', 'Affiliation': 'Division of Allergy, Asthma, and Immunology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Elaine Ying-Fang', 'Initials': 'EY', 'LastName': 'Chen', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yung-Ting', 'Initials': 'YT', 'LastName': 'Kuo', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Neurology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: pedkuoyt@tmu.edu.tw.'}, {'ForeName': 'Wen-Chuan', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: 09009@s.tmu.edu.tw.'}, {'ForeName': 'Shu-Huey', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Hematology and Oncology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: shu117@tmu.edu.tw.'}, {'ForeName': 'El-Wui', 'Initials': 'EW', 'LastName': 'Loh', 'Affiliation': 'Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; Shared Decision Making Resource Center, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Center for Evidence-Based Health Care, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: lohelwui@tmu.edu.tw.'}, {'ForeName': 'Shih-Yen', 'Initials': 'SY', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Gastroenterology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: 18159@s.tmu.edu.tw.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106244']
2676,32864542,Diabetes Telehealth Solutions: Improving Self-Management Through Remote Initiation of Continuous Glucose Monitoring.,"The purpose of this study was to evaluate feasibility of initiating continuous glucose monitoring (CGM) through telehealth as a means of expanding access. Adults with type 1 diabetes (N = 27) or type 2 diabetes using insulin (N = 7) and interest in starting CGM selected a CGM system (Dexcom G6 or Abbott FreeStyle Libre), which they received by mail. CGM was initiated with a certified diabetes care and education specialist providing instruction via videoconference or phone. The primary outcome was days per week of CGM use during the last 4 weeks. Hemoglobin A 1c (HbA 1c ) was measured at baseline and 12 weeks. Participant self-reported outcome measures were also evaluated. All 34 participants (mean age, 46 ± 18 years; 53% female, 85% white) were using CGM at 12 weeks, with 94% using CGM at least 6 days per week during weeks 9 to 12. Mean HbA 1c decreased from 8.3 ± 1.6 at baseline to 7.2 ± 1.3 at 12 weeks ( P < .001) and mean time in range (70-180 mg/dL, 3.9-10.0 mmol/L) increased from an estimated 48% ± 18% to 59% ± 20% ( P < .001), an increase of approximately 2.7 hours/day. Substantial benefits of CGM to quality of life were observed, with reduced diabetes distress, increased satisfaction with glucose monitoring, and fewer perceived technology barriers to management. Remote CGM initiation was successful in achieving sustained use and improving glycemic control after 12 weeks as well as improving quality-of-life indicators. If widely implemented, this telehealth approach could substantially increase the adoption of CGM and potentially improve glycemic control for people with diabetes using insulin.",2020,"Substantial benefits of CGM to quality of life were observed, with reduced diabetes distress, increased satisfaction with glucose monitoring, and fewer perceived technology barriers to management.","['Adults with type 1 diabetes (N\u2005=\u200527) or type 2 diabetes using insulin (N\u2005=\u20057) and interest in starting CGM selected a CGM system (Dexcom G6 or Abbott FreeStyle Libre), which they received by mail', 'All 34 participants (mean age, 46\u2005±\u200518 years; 53% female, 85% white', 'people with diabetes using insulin']","['continuous glucose monitoring (CGM', 'CGM']","['Mean HbA 1c', 'Hemoglobin A 1c (HbA 1c ', 'mean time in range', 'quality-of-life indicators', 'glycemic control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0521098,"Substantial benefits of CGM to quality of life were observed, with reduced diabetes distress, increased satisfaction with glucose monitoring, and fewer perceived technology barriers to management.","[{'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Gal', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Nathan J', 'Initials': 'NJ', 'LastName': 'Cohen', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Davida', 'Initials': 'D', 'LastName': 'Kruger', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'International Diabetes Center Park Nicollet, St Louis Park, Minnesota.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Terra', 'Initials': 'T', 'LastName': 'Cushman', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Haban', 'Affiliation': 'UW-Madison Dept. of Family Medicine and Community Health: Wisconsin Research and Education Network (WREN), Madison, Wisconsin.'}, {'ForeName': 'Korey', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'International Diabetes Center Park Nicollet, St Louis Park, Minnesota.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'McArthur', 'Affiliation': 'Cecelia Health, New York, New York.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Olson', 'Affiliation': 'Lagoon Health, Minneapolis, Minnesota.'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'SUNY Upstate Medical University, Syracuse, New York.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Oser', 'Affiliation': 'University of Colorado School of Medicine, Department of Family Medicine and State Network of Colorado Ambulatory Practices & Partners (SNOCAP), Aurora, Colorado.'}, {'ForeName': 'Tamara K', 'Initials': 'TK', 'LastName': 'Oser', 'Affiliation': 'University of Colorado School of Medicine, Department of Family Medicine and State Network of Colorado Ambulatory Practices & Partners (SNOCAP), Aurora, Colorado.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bugielski', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Strayer', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Aleppo', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvaa076']
2677,32867508,Comparison Between Ticagrelor and Clopidogrel in Elderly Patients With an Acute Coronary Syndrome: Insights From the SWEDEHEART Registry.,"BACKGROUND
The comparative efficacy and safety of ticagrelor versus clopidogrel in older patients with myocardial infarction (MI) has received limited study.
METHODS
We performed an observational analysis of all patients ≥80 years (n=14 005) who were discharged alive with aspirin combined with either clopidogrel (60.2%) or ticagrelor (39.8%) after a MI between 2010 and 2017 registered in the national registry SWEDEHEART (Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies). Inverse probability treatment weighting was used in Cox regression models to adjust for differences in demographics, in-hospital therapies, and medications. The primary ischemic outcome (death, MI, or stroke), and bleeding were obtained from national registries at 1 year. A sensitivity analysis in <80-year-old patients was performed.
RESULTS
In patients ≥80 years, the incidence of the primary ischemic outcome (hazard ratio [HR], 0.97 [95% CI, 0.88-1.06]) was similar for ticagrelor- and clopidogrel-treated patients. Ticagrelor was associated with a 17% and 48% higher risk of death (HR, 1.17 [95% CI, 1.03-1.32]) and bleeding (HR, 1.48 [95% CI, 1.25-1.76]), but a lower risk of MI (HR, 0.80 [95% CI, 0.70-0.92]) and stroke (HR, 0.72 [95% CI, 0.56-0.93]). In <80-year-old patients, the incidence of the primary ischemic outcome was 17% (HR, 0.83 [95% CI, 0.77-0.89]) lower with ticagrelor. Ticagrelor was associated with 15% (HR, 0.85 [95% CI, 0.76-0.96]) lower risk of death, 32% higher risk of bleeding (HR, 1.32 [95% CI, 1.18-1.47]), but lower risk of MI (HR, 0.82 [95% CI, 0.75-0.91]) and stroke (HR, 0.82 [95% CI, 0.69-0.98]).
CONCLUSIONS
Ticagrelor use among elderly patients with MI was associated with higher risk of bleeding and death compared with clopidogrel. A randomized study of ticagrelor versus clopidogrel in the elderly is needed.",2020,"Ticagrelor was associated with a 17% and 48% higher risk of death (1.17 (1.03- 1.32)) and bleeding (1.48 (1.25- 1.76)), but a lower risk of MI (0.80 (0.70- 0.92)) and stroke (0.72 (0.56-0.93)).","['elderly MI patients', 'all patients ≥80 years (n=14005) who were discharged alive with aspirin combined with either clopidogrel (60.2%) or ticagrelor (39.8%) after a MI between 2010 and 2017 registered in the national registry Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease', 'older myocardial infarction (MI) patients', 'Elderly Patients with an Acute Coronary Syndrome']","['Ticagrelor', 'Ticagrelor and Clopidogrel', 'ticagrelor vs. clopidogrel', 'clopidogrel', 'ticagrelor vs clopidogrel']","['risk of bleeding', 'risk of death', 'primary ischemic outcome', 'risk of bleeding and death', 'risk of MI', 'incidence of the primary ischemic outcome', 'stroke', 'primary ischemic outcome (death, MI or stroke), and bleeding', 'bleeding']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.113495,"Ticagrelor was associated with a 17% and 48% higher risk of death (1.17 (1.03- 1.32)) and bleeding (1.48 (1.25- 1.76)), but a lower risk of MI (0.80 (0.70- 0.92)) and stroke (0.72 (0.56-0.93)).","[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Szummer', 'Affiliation': 'Department of Medicine (Huddinge), Karolinska Institutet; Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden (K.S.).'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Montez-Rath', 'Affiliation': 'Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA (M.E.M.-R.).'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Alfredsson', 'Affiliation': 'Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Sweden (J.A.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Sweden (D.E.).'}, {'ForeName': 'Bertil', 'Initials': 'B', 'LastName': 'Lindahl', 'Affiliation': 'Department of Medical Sciences, Cardiology (B.L.), Uppsala University, Sweden.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Hofmann', 'Affiliation': 'Department of Clinical Science and Education, Division of Cardiology, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden (R.H., P.S.).'}, {'ForeName': 'Annica', 'Initials': 'A', 'LastName': 'Ravn-Fischer', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Sweden (A.R.-F.).'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Department of Clinical Science and Education, Division of Cardiology, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden (R.H., P.S.).'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jernberg', 'Affiliation': 'Department of Clinical Sciences, Danderyd University Hospital (T.J.), Karolinska Institutet, Stockholm, Sweden.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.050645']
2678,32867985,Effects of different egg turning frequencies on incubation efficiency parameters.,"This study aimed to evaluate the effects of different egg turning frequencies on incubation efficiency parameters. Nine hundred sixty brown fertile eggs, with an average weight of 52.20 ± 0.85 g, from 38-week-old CJD (Carijó Pesadão) breeder hens were randomly distributed among 4 treatments before incubation. Each treatment corresponded to a turning frequency, being 24 (control), 12, 6, or 3 times per day, at an angle of 45°, until day 18 of incubation. The experimental design was a randomized complete block design with 4 treatments. Analysis of the incubation parameters was based on 6 replications per treatment. The eggs that were turned 12, 6, and 3 times per day exhibited a decrease in hatchability of the fertile eggs of 6.61, 15.51, and 19.70%, respectively, when compared with the control group (91.84 ± 2.73%). With a decrease in turning frequency, there was a gradual increase in early (2.84 ± 1.89 to 14.31 ± 1.82%) and late (3.57 ± 1.39 to 8.05 ± 1.24%) mortality rates. An egg turning frequency of 24 times per day during incubation provided high hatchability rates. In contrast, the turning frequencies of 12, 6, and 3 times per day showed significant losses in hatchability.",2020,"In contrast, the turning frequencies of 12, 6, and 3 times per day showed significant losses in hatchability.","['Nine hundred sixty brown fertile eggs, with an average weight of 52.20\xa0±']",[],"['hatchability', 'mortality rates', 'turning frequency', 'hatchability of the fertile eggs', 'incubation efficiency parameters']","[{'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0455567,"In contrast, the turning frequencies of 12, 6, and 3 times per day showed significant losses in hatchability.","[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'da S Oliveira', 'Affiliation': 'Faculty of Agronomy and Veterinary Medicine (FAV), University of Brasília, Brasília 70.910-900, DF, Brazil.'}, {'ForeName': 'Vinícius M', 'Initials': 'VM', 'LastName': 'Dos Santos', 'Affiliation': 'Laboratory of Poultry Science, Federal Institute of Brasília - Campus Planaltina, Brasília 73.380-900, DF, Brazil. Electronic address: vinicius.santos@ifb.edu.br.'}, {'ForeName': 'Jullyana C', 'Initials': 'JC', 'LastName': 'Rodrigues', 'Affiliation': 'Laboratory of Poultry Science, Federal Institute of Brasília - Campus Planaltina, Brasília 73.380-900, DF, Brazil.'}, {'ForeName': 'Sheila T', 'Initials': 'ST', 'LastName': 'Nascimento', 'Affiliation': 'Faculty of Agronomy and Veterinary Medicine (FAV), University of Brasília, Brasília 70.910-900, DF, Brazil.'}]",Poultry science,['10.1016/j.psj.2020.05.045']
2679,32870712,Randomized head-to-head comparison of minodronic acid and raloxifene for fracture incidence in postmenopausal Japanese women: the Japanese Osteoporosis Intervention Trial (JOINT)-04.,"AIMS
We conducted a head-to-head randomized trial of minodronate, a bisphosphonate, and raloxifene, a selective estrogen receptor modulator, to obtain clinical evidence and information about their efficacy and safety.
METHODS
The Japanese Osteoporosis Intervention Trial protocol number 4 (JOINT-04) trial is a multi-center, open-labeled, blinded endpoints, head-to-head randomized trial of minodronate and raloxifene. Ambulatory elderly women with osteoporosis (age, >60 years) were randomly allocated to the raloxifene or minodronate group by central registration. The co-primary endpoints included any one of osteoporotic fractures (vertebral, humeral, femoral, and radial fractures), vertebral fractures, and major osteoporotic fractures (clinical vertebral, humeral, femoral, and radial fractures). The biological effects of each drug, patients' quality of life, and drug safety were assessed based on the secondary outcomes. This study was registered at the University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) under trial identification number UMIN000005433.
RESULTS
A total of 3896 patients were randomized to the minodronate and raloxifene groups, and drug efficacy assessments were performed for 3247 patients (1623 and 1624 patients, respectively). Among these patients, 1176 and 1187 patients received allocated treatment for 2 years. The incidence rate ratios for osteoporotic, vertebral, and major osteoporotic fractures in the minodronate group were 0.94 (95% CI: 0.78-1.13, p = .494), 0.86 (95% CI: 0.70-1.05, p = .147), and 1.22 (95% CI: 0.86-1.74, p = .274), respectively. Compared to the raloxifene group, the minodronate group showed significantly increased bone mineral density of the lumbar spine for each visit (6 months: p = .007, 12 months: p = .0003, 24 months: p <.0001). Also, serious adverse reactions were observed for four and six patients in the minodronate and raloxifene groups, respectively.
CONCLUSIONS
Overall, there were no statistical differences in the incidence rates of osteoporotic, vertebral, or major osteoporotic fractures between the two groups. Serious adverse reactions were rare in both groups.",2020,"Overall, there were no statistical differences in the incidence rates of osteoporotic, vertebral, or major osteoporotic fractures between the two groups.","['postmenopausal Japanese women', '3896 patients', 'Ambulatory elderly women with osteoporosis (age, >60 years', '3247 patients (1623 and 1624 patients, respectively']","['minodronate and raloxifene', 'raloxifene', 'minodronic acid and raloxifene', 'bisphosphonate, and raloxifene', 'raloxifene or minodronate group by central registration']","['bone mineral density of the lumbar spine', 'osteoporotic fractures (vertebral, humeral, femoral, and radial fractures), vertebral fractures, and major osteoporotic fractures (clinical vertebral, humeral, femoral, and radial fractures', 'incidence rates of osteoporotic, vertebral, or major osteoporotic fractures', 'incidence rate ratios for osteoporotic, vertebral, and major osteoporotic fractures', 'quality of life, and drug safety', 'serious adverse reactions', 'Serious adverse reactions']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0662880', 'cui_str': 'minodronate'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",3896.0,0.0666248,"Overall, there were no statistical differences in the incidence rates of osteoporotic, vertebral, or major osteoporotic fractures between the two groups.","[{'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'Department of Data Science, Biostatistics Section, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Teruki', 'Initials': 'T', 'LastName': 'Sone', 'Affiliation': 'Department of Nuclear Medicine, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Clinical Biostatistics, Graduate School of Medicine Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Miyazaki', 'Affiliation': 'Public Health Research Foundation, Tokyo, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Tsukiyama', 'Affiliation': 'Public Health Research Foundation, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Taguchi', 'Affiliation': 'Department of Oral and Maxillofacial Radiology, School of Dentistry, Matsumoto Dental University, Nagano, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Soen', 'Affiliation': 'Department of Orthopaedic Surgery and Rheumatology, Nara Hospital, Kindai University, Nara, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Mori', 'Affiliation': 'Bone and Joint Surgery, Seirei Hamamatu General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hagino', 'Affiliation': 'School of Health Science, Tottori University faculty of Medicine, Tottori, Japan.'}, {'ForeName': 'Toshitsugu', 'Initials': 'T', 'LastName': 'Sugimoto', 'Affiliation': 'Eikokai Ono Hospital, Hyogo, Japan.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Fukunaga', 'Affiliation': 'Department of Nuclear Medicine, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Ohta', 'Affiliation': 'International Medical Center, Fujita Health University, Aichi, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Japan Osteoporosis Foundation, Tokyo, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Orimo', 'Affiliation': 'Japan Osteoporosis Foundation, Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Shiraki', 'Affiliation': 'Department of Internal Medicine, Research Institute and Practice for Involutional Diseases, Nagano, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Current medical research and opinion,['10.1080/03007995.2020.1816537']
2680,32871397,Neuromuscular training improves knee proprioception in athletes with a history of anterior cruciate ligament reconstruction: A randomized controlled trial.,"BACKGROUND
Athletes exhibit deficits in knee proprioception following anterior cruciate ligament reconstruction. Neuromuscular training programs improve knee proprioception in uninjured athletes; however, the effects on knee proprioception in athletes who have undergone anterior cruciate ligament reconstruction is not well understood. The purpose of this study was to examine the effects of a neuromuscular training program on knee proprioception in athletes who have returned to sport following anterior cruciate ligament reconstruction.
METHODS
Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12 months and returned to sport, participated in this randomized controlled trial. Athletes were randomly allocated to an experimental group (n = 12) that took part in an 8-week neuromuscular training program or a control group (n = 12) that simply continued their typical training routine. Knee position sense was assessed at baseline and after the 8-week period (post-testing). One-way analysis of covariance, with baseline performance included as a covariate, was used to compare knee position sense errors for the reconstructed limbs of the experimental and control groups at the post-testing time point.
FINDINGS
Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period. As a result, the experimental group demonstrated lower knee position sense errors, compared to the control group, at the post-testing time point (P < .001).
INTERPRETATION
Athletes with a history of anterior cruciate ligament reconstruction may benefit from participation in a neuromuscular training program, even after completing post-operative rehabilitation.",2020,"FINDINGS
Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","['athletes who have undergone anterior cruciate ligament reconstruction', 'Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12\xa0months and returned to sport', 'anterior cruciate ligament reconstruction', 'athletes who have returned to sport following anterior cruciate ligament reconstruction', 'athletes with a history of anterior cruciate ligament reconstruction', 'Athletes with a history of anterior cruciate ligament reconstruction', 'uninjured athletes']","['Neuromuscular training', 'neuromuscular training program', 'Neuromuscular training programs', 'neuromuscular training program or a control group (n\xa0=\xa012) that simply continued their typical training routine']","['lower knee position sense errors', 'knee proprioception', 'Knee position sense errors', 'Knee position sense']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]",24.0,0.0152322,"FINDINGS
Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghaderi', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Thomas Gus', 'Initials': 'TG', 'LastName': 'Almonroeder', 'Affiliation': 'University of Wisconsin - La Crosse, 1300 Badger St., La Crosse, WI 54601, United States. Electronic address: talmonroeder@uwlax.edu.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Keyhani', 'Affiliation': 'Akhtar Hospital, Shahid Beheshti University of Medical Sciences, Velenjak St., Tehran 19857-17443, Iran.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105157']
2681,32877859,The influence of center line width during the crossover hop test.,"OBJECTIVES
To assess the influence of center line width on crossover hop for distance test (XHOP) performance.
DESIGN
Repeated measures.
SETTING
University laboratory.
PARTICIPANTS
33 physically active females without history of a ligamentous knee injury (age: 22.5 ± 2.3 years).
MAIN OUTCOME MEASURES
Hop distance was measured during four XHOP conditions with variations in center line width: 2.54 cm (narrow), 15 cm (standard), 12.5% of the participants' height (HT1), and 25% of the participants' height (HT2). A repeated measures ANOVA was used to evaluate differences in hop distance for XHOP condition (narrow, standard, HT1, and HT2).
RESULTS
Differences in hop distance were shown on XHOP condition (p < 0.001). Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
CONCLUSIONS
No differences in hop distance were identified between narrow and standard center line width XHOP conditions in healthy females. Decreased hop distance was shown when center line width was normalized to 25% of participant height in comparison to all other XHOP conditions, with medium effect sizes. This study highlights hop distance outcomes based on different XHOP center line widths, normalizing the XHOP according to height, and potential implications for frontal plane knee loading during the XHOP in healthy individuals.",2020,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","['33 physically active females without history of a ligamentous knee injury (age: 22.5\xa0±\xa02.3 years', 'healthy females', 'University laboratory', 'healthy individuals']",[],"['distance test (XHOP) performance', 'XHOP condition', 'XHOP condition (narrow, standard, HT1, and HT2']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C4517649', 'cui_str': '22.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0450565', 'cui_str': 'HT1'}, {'cui': 'C0450566', 'cui_str': 'HT2'}]",33.0,0.0332208,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","[{'ForeName': 'Brandon M', 'Initials': 'BM', 'LastName': 'Ness', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA; Doctor of Physical Therapy Program, Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Ave, Boston, MA, 02111, USA. Electronic address: Brandon.Ness@tufts.edu.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Albright', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Ehlers', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Glasoe', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Selby', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Kory', 'Initials': 'K', 'LastName': 'Zimney', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kernozek', 'Affiliation': 'Department of Health Professions, Physical Therapy Program, La Crosse Institute for Movement Science, University of Wisconsin - La Crosse, 1725 State Street, La Crosse, WI, 54601, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.005']
2682,32877884,Reduced morbidity by using LigaSure compared to conventional inguinofemoral lymphadenectomy in vulvar cancer patients: A randomized controlled trial.,"BACKGROUND
Inguinofemoral lymphadenectomy (IFL) is part of the surgical treatment of different malignancies of the genital tract and/or the lower limb including vulvar carcinoma, penile carcinoma and melanoma. IFL is associated with morbidity in up to 85% of the patients. The aims of this MAMBO-IC study (Morbidity And Measurement of the Body) are to study the feasibility of using LigaSure for IFL and to assess the differences in the incidence of short-term complications using LigaSure versus conventional IFL randomized within each individual patient.
METHODS
In this multicenter randomized controlled trial (RCT), women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included. It was randomly assigned for which groin the LigaSure was used; the other groin was treated with conventional IFL (sharp/diathermia). We estimated the incidence of ≥1 complication(s) per groin using logistic regression and compared this between the two surgical methods, adjusting for possible confounders.
RESULTS
We included 40 groins of 20 patients. The estimated incidence of ≥1 complication(s) was 29% after LigaSure versus 70% after conventional IFL (risk difference 41% (95% CI 19-62), p < 0.001). Patients' reported restriction of daily living activities and maximum pain score were equal for both treatment methods. There were no differences in the surgeon reported workload scores.
CONCLUSIONS
This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL. Further studies with a larger sample size are needed to validate our findings. ISRCTN15057626.",2020,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"['40 groins of 20 patients', 'vulvar cancer patients', 'women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included']","['conventional IFL (sharp/diathermia', 'Inguinofemoral lymphadenectomy (IFL', 'IFL', 'conventional inguinofemoral lymphadenectomy', 'LigaSure']","['restriction of daily living activities and maximum pain score', 'morbidity', 'estimated incidence of ≥1 complication(s']","[{'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0375071', 'cui_str': 'Malignant tumor of vulva'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0280856', 'cui_str': 'Squamous cell carcinoma of vulva'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.247773,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"[{'ForeName': 'Anne-Floor W', 'Initials': 'AW', 'LastName': 'Pouwer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands. Electronic address: Anne-Floor.W.Pouwer@radboudumc.nl.'}, {'ForeName': 'Henriette J', 'Initials': 'HJ', 'LastName': 'Arts', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, Department of Obstetrics and Gynaecology, the Netherlands.'}, {'ForeName': 'Corine M', 'Initials': 'CM', 'LastName': 'Koopmans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Johanna M A', 'Initials': 'JMA', 'LastName': 'Pijnenborg', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanne A', 'Initials': 'JA', 'LastName': 'de Hullu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.011']
2683,32878764,"Intensive Care Weaning (iCareWean) protocol on weaning from mechanical ventilation: a single-blinded multicentre randomised control trial comparing an open-loop decision support system and routine care, in the general intensive care unit.","INTRODUCTION
Automated systems for ventilator management to date have been either fully heuristic rule-based systems or based on a combination of simple physiological models and rules. These have been shown to reduce the duration of mechanical ventilation in simple to wean patients. At present, there are no published studies that evaluate the effect of systems that use detailed physiological descriptions of the individual patient.The BEACON Caresystem is a model-based decision support system that uses mathematical models of patients' physiology in combination with models of clinical preferences to provide advice on appropriate ventilator settings. An individual physiological description may be particularly advantageous in selecting the appropriate therapy for a complex, heterogeneous, intensive care unit (ICU) patient population.
METHODS AND ANALYSIS
Intenive Care weaning (iCareWean) is a single-blinded, multicentre, prospective randomised control trial evaluating management of mechanical ventilation as directed by the BEACON Caresystem compared with that of current care, in the general intensive care setting. The trial will enrol 274 participants across multiple London National Health Service ICUs. The trial will use a primary outcome of duration of mechanical ventilation until successful extubation.
ETHICS AND DISSEMINATION
Safety oversight will be under the direction of an independent committee of the study sponsor. Study approval was obtained from the regional ethics committee of the Health Research Authority (HRA), (Research Ethic Committee (REC) reference: 17/LO/0887. Integrated Research Application System (IRAS) reference: 226610. Results will be disseminated through international critical care conference/symposium and publication in peer-reviewed journal.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov under NCT03249623. This research is registered with the National Institute for Health Research under CPMS ID: 34831.",2020,"Intenive Care weaning (iCareWean) is a single-blinded, multicentre, prospective randomised control trial evaluating management of mechanical ventilation as directed by the BEACON Caresystem compared with that of current care, in the general intensive care setting.",['274 participants across multiple London National Health Service ICUs'],"['Intensive Care Weaning (iCareWean) protocol', 'Intenive Care weaning (iCareWean']",[],"[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}]","[{'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",[],,0.189947,"Intenive Care weaning (iCareWean) is a single-blinded, multicentre, prospective randomised control trial evaluating management of mechanical ventilation as directed by the BEACON Caresystem compared with that of current care, in the general intensive care setting.","[{'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Vizcaychipi', 'Affiliation': 'APMIC, Imperial College London, London, UK m.vizcaychipi@imperial.ac.uk.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Martins', 'Affiliation': 'Research Trial Unit, Chelsea and Westminster Hospital NHS Foundation Trust, London, London, UK.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'White', 'Affiliation': 'Magill Department of Anaesthesia, Chelsea and Westminster Hospital NHS Foundation Trust, London, London, UK.'}, {'ForeName': 'Dan Stleper', 'Initials': 'DS', 'LastName': 'Karbing', 'Affiliation': 'Center for Model-based Medical Decision Support, Aalborg Universitet, Aalborg, Denmark.'}, {'ForeName': 'Amandeep', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Anaesthetic Department, West Middlesex University Hospital NHS Trust, London, London, UK.'}, {'ForeName': 'Suveer', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Magill Department of Anaesthesia and Intensive Care Medicine, Chelsea and Westminster Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Osman', 'Affiliation': 'Magill Department of Anaesthesia, Chelsea and Westminster Hospital NHS Foundation Trust, London, London, UK.'}, {'ForeName': 'Jeronimo', 'Initials': 'J', 'LastName': 'Moreno-Cuesta', 'Affiliation': 'Anaesthetic Department, North Middlesex University Hospital NHS Trust, London, London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Rees', 'Affiliation': 'Department of Health Science and Technology, Aalborg Universitet Institut for Medicin og Sundhedsteknologi, Aalborg, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-042145']
2684,30972696,Population Pharmacokinetics/Pharmacodynamics of Ticagrelor in Children with Sickle Cell Disease.,"BACKGROUND AND OBJECTIVE
Ticagrelor, a reversible P2Y 12 platelet inhibitor, is under investigation as a sickle cell disease (SCD) therapy in children. HESTIA1 (NCT02214121) was the first ticagrelor study generating pharmacokinetic (PK), pharmacodynamic (PD, P2Y 12 reactivity units [PRU]), and safety data in 45 pediatric SCD patients. Population PK and PK/PD relationships for ticagrelor were quantified using a PK approach.
METHODS
An adult population PK model was refined to describe ticagrelor and AR-C124910XX (active metabolite) plasma concentration and time data over a wide range of single/repeated ticagrelor doses (0.125-2.25 mg/kg). Population PK/PD modeling was used to describe the time course and extent of platelet inhibition. Demographic covariate relationships were investigated.
RESULTS
The final population PK model adequately described ticagrelor and AR-C124910XX plasma concentrations over time. An allometric body weight relationship between ticagrelor and AR-C124910XX clearances and volumes of distribution was used. Significant covariates for ticagrelor were sex (relative bioavailability) and cholecystectomy (central volume of distribution). Estimated oral clearances (35 kg patient; median bodyweight) were 22.8 L/h (ticagrelor) and 9.97 L/h (AR-C124910XX). The final population PK/PD model well-described the time course and extent of platelet inhibition. Estimated baseline PRU was 283, maximum PRU effect was fixed at 1, and the ticagrelor concentration for half-maximum PRU effect was 233 nmol/L.
CONCLUSIONS
These analyses offer the first quantitative characterization of the dose-exposure-response relationship for ticagrelor in pediatric SCD patients. This model-based approach may be used to inform dose selection and design of subsequent studies that aim to define ticagrelor safety and efficacy in pediatric SCD patients.",2019,The final population PK model adequately described ticagrelor and AR-C124910XX plasma concentrations over time.,"['Children with Sickle Cell Disease', '45 pediatric SCD patients', 'sickle cell disease (SCD) therapy in children', 'pediatric SCD patients']",['Ticagrelor'],"['ticagrelor safety and efficacy', 'sex (relative bioavailability) and cholecystectomy (central volume of distribution', 'maximum PRU effect', 'Estimated oral clearances', 'pharmacokinetic (PK), pharmacodynamic (PD, P2Y 12 reactivity units [PRU]), and safety data', 'ticagrelor and AR-C124910XX (active metabolite) plasma concentration and time data', 'ticagrelor and AR-C124910XX plasma concentrations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C3254492', 'cui_str': 'AR C124910XX'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0506092,The final population PK model adequately described ticagrelor and AR-C124910XX plasma concentrations over time.,"[{'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Amilon', 'Affiliation': 'Quantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden. carl.amilon@astrazeneca.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Niazi', 'Affiliation': 'Quantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Berggren', 'Affiliation': 'Global Medicines Department, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Åstrand', 'Affiliation': 'Quantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Hamrén', 'Affiliation': 'Quantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}]",Clinical pharmacokinetics,['10.1007/s40262-019-00758-0']
2685,32886456,From the completion of neoadjuvant chemotherapy to surgery for colorectal cancer liver metastasis: What is the optimal timing?,"BACKGROUND
Neoadjuvant chemotherapy (NAC) has been widely performed in the treatment of colorectal cancer liver metastasis (CRLM) patients, but the optimal timing of surgery after NAC is unclear. The aim of this study was to investigate the optimal timing of surgery.
METHODS
From December 2010 to May 2018, 101 consecutive patients who received NAC followed by liver resection for CRLM were included in this study. The main outcome parameters were pathological response, progression-free survival (PFS), and overall survival (OS). The effect of time to surgery (TTS) on patient outcomes, defined as a high TTS and a low TTS according to an X-tile analysis, was investigated. To adjust for potential selection bias, propensity score matching at 1:2 was performed with two high TTS patients matched to one low TTS patient. Kaplan-Meier curves, logistic regression analyses, and Cox regression models were used for the data analysis.
RESULTS
The optimal cut-off value for the TTS was 5 weeks by X-tile analysis. The patients in this study were divided into low (≤5 weeks, n = 27) and high (>5 weeks, n = 74) TTS groups. Patients with a high TTS were more likely to have an unfavorable pathological response (75.7% vs 48.1%, P = .008). In multivariate analysis, a low TTS significantly predicted a better pathological response (OR = 3.397, 95% CI: 1.116-10.344, P = .031). Compared to patients with a high TTS, patients with a low TTS had significantly better PFS (P < .001, mPFS: 16 months vs 7 months) and better OS (P = .037, mOS: not reached vs 36 months). Multivariate analysis revealed that a TTS > 5 weeks was an independent predictor of decreased PFS (HR = 2.041, 95% CI: 1.152-3.616, P = .014) but not OS. After propensity matching, the patients with a low TTS had significantly better PFS (P < .001, mPFS: 18.2 months vs 10 months) and an equivalent OS (P = .115, mOS: not reached vs 41 months). Multivariate analysis revealed that a TTS > 5 weeks was an independent predictor of decreased PFS (HR = 3.031, 95% CI: 1.494-6.149, P = .002) but not OS.
CONCLUSION
The longer TTS after the completion of NAC may be disadvantageous for a favorable pathological response and long-term PFS. These results should be validated prospectively in a randomized trial.",2020,"16 months vs 7 months) and better OS (P = .037, mOS: not reached vs 36 months).","['colorectal cancer liver metastasis', '101 consecutive patients who received NAC followed by liver resection for CRLM', 'From December 2010 to May 2018', 'colorectal cancer liver metastasis (CRLM) patients']","['mPFS', 'Neoadjuvant chemotherapy (NAC', 'surgery (TTS', 'neoadjuvant chemotherapy']","['unfavorable pathological response', 'pathological response, progression-free survival (PFS), and overall survival (OS', 'PFS', 'pathological response', 'better OS']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",101.0,0.0593292,"16 months vs 7 months) and better OS (P = .037, mOS: not reached vs 36 months).","[{'ForeName': 'Qichen', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Mao', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Bi', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yefan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jianqiang', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Cancer medicine,['10.1002/cam4.3283']
2686,32882314,Treatment of giardiasis in children: Randomized trial of rectal metronidazole versus oral tinidazole.,,2020,Side effects were reported in one patient and were restricted to a single episode of loose stool after the third dose of rectal metronidazole.,"['children with giardiasis', 'giardiasis in children']","['metronidazole', 'tinidazole', 'rectal metronidazole', 'rectal metronidazole and single-dose oral tinidazole', 'oral tinidazole']","['Clinical cure', 'efficacy, safety and acceptance', 'Side effects', 'Microbiological eradication']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0017536', 'cui_str': 'Giardiasis'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0040263', 'cui_str': 'Tinidazole'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}]",,0.072253,Side effects were reported in one patient and were restricted to a single episode of loose stool after the third dose of rectal metronidazole.,"[{'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Vakkilainen', 'Affiliation': ""New Children's Hospital, Pediatric Research Center, University of Helsinki and HUS Helsinki University Hospital, Stenbäckinkatu 9, PL 347, 00290 Helsinki, Finland. Electronic address: svetlana.vakkilainen@hus.fi.""}, {'ForeName': 'Tea', 'Initials': 'T', 'LastName': 'Nieminen', 'Affiliation': ""New Children's Hospital, Pediatric Research Center, University of Helsinki and HUS Helsinki University Hospital, Stenbäckinkatu 9, PL 347, 00290 Helsinki, Finland.""}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Björkbacka', 'Affiliation': ""New Children's Hospital, Pediatric Research Center, University of Helsinki and HUS Helsinki University Hospital, Stenbäckinkatu 9, PL 347, 00290 Helsinki, Finland.""}, {'ForeName': 'Tarja', 'Initials': 'T', 'LastName': 'Saavalainen-Hakala', 'Affiliation': ""New Children's Hospital, Pediatric Research Center, University of Helsinki and HUS Helsinki University Hospital, Stenbäckinkatu 9, PL 347, 00290 Helsinki, Finland.""}, {'ForeName': 'Eeva', 'Initials': 'E', 'LastName': 'Salo', 'Affiliation': ""New Children's Hospital, Pediatric Research Center, University of Helsinki and HUS Helsinki University Hospital, Stenbäckinkatu 9, PL 347, 00290 Helsinki, Finland.""}]",The Journal of infection,['10.1016/j.jinf.2020.08.050']
2687,32882447,Effect of Aflibercept on Diabetic Retinopathy Severity and Visual Function in the RECOVERY Study for Proliferative Diabetic Retinopathy.,"PURPOSE
To evaluate the effect of intravitreal aflibercept on diabetic retinopathy (DR) severity and visual function in patients with proliferative DR (PDR) without diabetic macular edema (DME).
DESIGN
Prospective, longitudinal, multicenter clinical trial.
PARTICIPANTS
Forty eyes of 40 patients with PDR and no DME were enrolled in this study. Patients were randomized into monthly and quarterly 2-mg aflibercept injection cohorts and were treated over a period of 12 months.
METHODS
All patients underwent ultra-widefield fundus imaging including pseudocolor and fluorescein angiography using an Optos 200Tx device.
MAIN OUTCOME MEASURES
Severity of DR at baseline, month 6, and month 12 was evaluated using the DR severity scale (DRSS). The DRSS scores were correlated with the 25-item Visual Function Questionnaire (VFQ-25) and 39-item Visual Function Questionnaire (VFQ-39) scores at baseline and month 12.
RESULTS
Mean age of the patients was 48.2 years (range, 25-75 years), mean duration of diabetes mellitus was 16.1 years (range, 2-36 years), and median glycated hemoglobin level was 8.8% (IQR, 7.4%-10%). Both monthly and quarterly groups demonstrated a statistically significant regression in DRSS from baseline to month 12 (P < 0.001). The monthly group demonstrated a statistically significant greater regression of DRSS score at the month 6 visit compared with the quarterly group (P = 0.019). However, the difference between the two groups became statistically insignificant at month 12 visit (P = 0.309). Also no difference was found in mean VFQ-25 and VFQ-39 composite scores between the monthly and quarterly groups at month 12 (P = 0.947 and P = 0.921, respectively). The improvement in mean VFQ-25 and VFQ-39 composite scores at month 12 was correlated significantly with improvement in DRSS score (r = 0.384 and P = 0.039, and r = 0.361 and P = 0.046, respectively).
CONCLUSIONS
In this study of eyes with PDR without DME, both monthly and quarterly aflibercept injection groups showed significant improvement in DR severity at month 12 compared with baseline. The improvement in DRSS score was associated with an improvement in VFQ-25 and VFQ-39 composite score.",2020,"There was also no difference in mean VFQ-25 and VFQ-39 composite scores between the monthly and quarterly groups at month 12 (p= 0.947, 0.921, respectively).","['Forty eyes of 40 subjects with PDR and no DME were enrolled in this study', 'Proliferative Diabetic Retinopathy', 'subjects with proliferative diabetic retinopathy (PDR) without diabetic macular edema (DME', 'Mean age of the subjects was 48.2 years (range 25-75), mean duration of diabetes mellitus was 16.1 years (range 2-36 years) and median HbA1c was 8.8% (IQR 7.4-10']","['Aflibercept', 'aflibercept injection', 'intravitreal aflibercept', 'ultra-wide field (UWF) fundus imaging including pseudocolor and fluorescein angiography using an Optos 200Tx device (Optos, Dunfermline, UK']","['VFQ composite score', 'Diabetic Retinopathy Severity and Visual Function', 'DRSS scores', 'diabetic retinopathy severity scale (DRSS', '25-item and 39-item Visual Function Questionnaire scores', 'DRSS', 'DRSS score', 'diabetic retinopathy severity', 'mean VFQ-25 and VFQ-39 composite scores', 'diabetic retinopathy severity and visual function']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191314', 'cui_str': '48.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C4517858', 'cui_str': '7.4'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",40.0,0.0347998,"There was also no difference in mean VFQ-25 and VFQ-39 composite scores between the monthly and quarterly groups at month 12 (p= 0.947, 0.921, respectively).","[{'ForeName': 'Ahmed Roshdy', 'Initials': 'AR', 'LastName': 'Alagorie', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California; Department of Ophthalmology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Swetha', 'Initials': 'S', 'LastName': 'Velaga', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Muneeswar Gupta', 'Initials': 'MG', 'LastName': 'Nittala', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Hannah J', 'Initials': 'HJ', 'LastName': 'Yu', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California. Electronic address: SSadda@doheny.org.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.08.018']
2688,32888702,Effectiveness of a 12-Week Physical Exercise Program on Lower-Limb Malalignment in School-age Rugby: A Randomized Clinical Trial.,"OBJECTIVE
We sought to assess the effectiveness of 12 weeks of a physical exercise program (PEP) in child rugby players with lower-limb overpronation during gait.
METHODS
This was a randomized clinical trial. A total of 123 young athletes (mean ± standard deviation age, 10.35 ± 1.22 years) were evaluated, 20 of whom had lower-limb overpronation (n = 40 extremities). Participants were randomly assigned to 2 groups: the experimental group, who performed their normal training and a PEP for 12 weeks, and the control group, who continued with their normal training for the same time. The PEP was focused on stretching the hypertonic muscle and potentiating the weakened muscles of the lower body. All participants underwent biomechanical analysis including the Helbing angle, the femorotibial angle, and the Fick angle in both limbs.
RESULTS
All participants (n = 20) completed the study. Baseline measurements showed no significant differences between groups in any of the variables tested. After 12 weeks, there were significant differences between groups (P < .001 for all angles). No improvement was found in the control group; however, meaningful improvement was found in all variables in the experimental group: Helbing angle (175°, P < .001, effect size [ES] = 1.94), femorotibial angle (173°, P < .001, ES = 1.77), Fick angle (12°, P < .001, ES = 1.55). The number needed to treat was 2 for femorotibial angle and Helbing angle, and 3 for Fick angle.
CONCLUSION
A 12-week PEP produced significant improvements in these 3 biomechanical variables. We also conclude that young athletes with a pathological gait pattern reached a normal gait pattern.",2020,"No improvement was found in the control group; however, meaningful improvement was found in all variables in the experimental group: Helbing angle (175°, P < .001, effect size [ES] = 1.94), femorotibial angle (173°, P < .001, ES = 1.77), Fick angle (12°, P < .001, ES = 1.55).","['Lower-Limb Malalignment in School-age Rugby', '123 young athletes (mean ± standard deviation age, 10.35 ± 1.22 years) were evaluated, 20 of whom had lower-limb overpronation (n\u202f=\u202f40 extremities', 'All participants (n\u202f=\u202f20) completed the study', 'young athletes with a pathological gait pattern reached a normal gait pattern', 'child rugby players with lower-limb overpronation during gait']","['physical exercise program (PEP', 'normal training and a PEP', '12-Week Physical Exercise Program']","['femorotibial angle', 'Fick angle']","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0231683', 'cui_str': 'Gait normal'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}]",123.0,0.0604923,"No improvement was found in the control group; however, meaningful improvement was found in all variables in the experimental group: Helbing angle (175°, P < .001, effect size [ES] = 1.94), femorotibial angle (173°, P < .001, ES = 1.77), Fick angle (12°, P < .001, ES = 1.55).","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'De-la-Cruz-Torres', 'Affiliation': 'Department of Physiotherapy, University of Seville, Seville, Spain. Electronic address: bcruz@us.es.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Sánchez-López', 'Affiliation': 'Private sports medicine clinic, Seville, Spain.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.11.003']
2689,32891234,Financial incentives to promote retention in care and viral suppression in adults with HIV initiating antiretroviral therapy in Tanzania: a three-arm randomised controlled trial.,"BACKGROUND
Financial incentives promote use of HIV services and might support adherence to the sustained antiretroviral therapy (ART) necessary for viral suppression, but few studies have assessed a biomarker of adherence or evaluated optimal implementation. We sought to determine whether varying sized financial incentives for clinic attendance effected viral suppression in patients starting ART in Tanzania.
METHODS
In a three-arm, parallel-group, randomised controlled trial at four health facilities in Shinyanga region, Tanzania, adults aged 18 years or older with HIV who had started ART within the past 30 days were randomly assigned (1:1:1) using a tablet-based application (stratified by site) to receive usual care (control group) or to receive a cash incentive for monthly clinic attendance in one of two amounts: 10 000 Tanzanian Shillings (TZS; about US$4·50) or 22 500 TZS (about $10·00). There were no formal exclusion criteria. Participants were masked to the existence of two incentive sizes. Incentives were provided for up to 6 months via mobile health technology (mHealth) that linked biometric attendance monitoring to automated mobile payments. We evaluated the primary outcome of retention in care with viral suppression (<1000 copies per mL) at 6 months using logistic regression. This trial is registered with ClinicalTrials.gov, NCT03351556.
FINDINGS
Between April 24 and Dec 14, 2018, 530 participants were randomly assigned to an incentive strategy (184 in the control group, 172 in the smaller incentive group, and 174 in the larger incentive group). All participants were included in the primary intention-to-treat analysis. At 6 months, approximately 134 (73%) participants in the control group remained in care and had viral suppression, compared with 143 (83%) in the smaller incentive group (risk difference [RD] 9·8, 95% CI 1·2 to 18·5) and 150 (86%) in the larger incentive group (RD 13·0, 4·5 to 21·5); we identified a positive trend between incentive size and viral suppression (p trend=0·0032), although the incentive groups did not significantly differ (RD 3·2, -4·6 to 11·0). Adverse events included seven (4%) deaths in the control group and 11 (3%) deaths in the intervention groups, none related to study participation.
INTERPRETATION
Small financial incentives delivered using mHealth can improve retention in care and viral suppression in adults starting HIV treatment. Although further research should investigate the durability of effects from short-term incentives, these findings strengthen the evidence for implementing financial incentives within standard HIV care.
FUNDING
National Institute of Mental Health at the US National Institutes of Health.",2020,"Adverse events included seven (4%) deaths in the control group and 11 (3%) deaths in the intervention groups, none related to study participation.
","['adults with HIV initiating antiretroviral therapy in Tanzania', 'All participants were included in the primary intention-to-treat analysis', 'adults starting HIV treatment', 'adults aged 18 years or older with HIV who had started ART within the past 30 days', 'Between April 24 and Dec 14, 2018, 530 participants were randomly assigned to an incentive strategy (184 in the control group, 172 in the smaller incentive group, and 174 in the larger incentive group', 'patients starting ART in Tanzania']",['tablet-based application (stratified by site) to receive usual care (control group) or to receive a cash incentive for monthly clinic attendance in one of two amounts: 10\u2008000 Tanzanian Shillings (TZS; about US$4·50) or 22\u2008500 TZS'],"['viral suppression', 'retention in care with viral suppression', 'incentive size and viral suppression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",530.0,0.294879,"Adverse events included seven (4%) deaths in the control group and 11 (3%) deaths in the intervention groups, none related to study participation.
","[{'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Fahey', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, CA, USA. Electronic address: cfahey@berkeley.edu.'}, {'ForeName': 'Prosper F', 'Initials': 'PF', 'LastName': 'Njau', 'Affiliation': 'Ministry of Health, Community Development, Gender, Elderly and Children, Dodoma, Tanzania; Health for a Prosperous Nation, Dar es Salaam, Tanzania.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Katabaro', 'Affiliation': 'Health for a Prosperous Nation, Dar es Salaam, Tanzania.'}, {'ForeName': 'Rashid S', 'Initials': 'RS', 'LastName': 'Mfaume', 'Affiliation': 'Ministry of Health, Community Development, Gender, Elderly and Children, Dodoma, Tanzania.'}, {'ForeName': 'Nzovu', 'Initials': 'N', 'LastName': 'Ulenga', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Natalino', 'Initials': 'N', 'LastName': 'Mwenda', 'Affiliation': 'Rasello, Dar es Salaam, Tanzania.'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Bradshaw', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Dow', 'Affiliation': 'Department of Health Policy and Management, School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Padian', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Jewell', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Sandra I', 'Initials': 'SI', 'LastName': 'McCoy', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, CA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30230-7']
2690,32891527,Wearable and interactive technology to share fitness goals results in weight loss but not improved diabetes outcomes.,"BACKGROUND AND PURPOSE
To investigate the effects of adding virtual activity groups to a multicomponent ambulatory activity monitoring intervention in managing chronic conditions such as obesity and type 2 diabetes.
METHODS
We randomized 120 subjects with type 2 diabetes to receive an activity monitor with or without placement into virtual activity groups. We monitored subjects over six months and collected HbA1c, weight, step count, blood pressure, and SF-36 questionnaire data.
RESULTS
All subjects lost significant weight over the course of the study (p = 0.005); however, there was no statistically significant difference in mean weight loss between two groups (p = 0.520). HbA1c decreased in both groups, but was not statistically significant (p = 0.084). Daily step counts were similar between groups (p = 0.633), but both groups did decrease significantly over time (p = 0.004). There was no linear correlation between daily step count and HbA1c (p = 0.609), but there was between daily step count and weight (p = 0.016) although this only accounted for 5.6% of weight loss. There were no significant differences found for blood pressure and Rand SF36 measures between groups or times, or group-time interactions with two exceptions. The SF36 Role functioning/emotional measure showed an interaction between group and time (p = 0.039) and the SF36 Health Change measure had a significant difference due to time irrespective of group (p < 0.0001). Compliance remained high, with 93.8% of subjects actively participating at the conclusion of the study.
CONCLUSIONS
Activity monitoring with in-person goal-setting and scripted feedback over six months was associated with significant weight loss with or without virtual support groups.",2020,The SF36 Role functioning/emotional measure showed an interaction between group and time (p = 0.039) and the SF36 Health Change measure had a significant difference due to time irrespective of group (p < 0.0001).,['120 subjects with type 2 diabetes to receive an'],"['multicomponent ambulatory activity monitoring intervention', 'activity monitor with or without placement into virtual activity groups']","['weight loss', 'Daily step counts', 'collected HbA1c, weight, step count, blood pressure, and SF-36 questionnaire data', 'mean weight loss', 'blood pressure and Rand SF36 measures', 'SF36 Health Change measure', 'HbA1c']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",120.0,0.0201026,The SF36 Role functioning/emotional measure showed an interaction between group and time (p = 0.039) and the SF36 Health Change measure had a significant difference due to time irrespective of group (p < 0.0001).,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lystrup', 'Affiliation': '99th MDG, Nellis Air Force Base, NV, 89191, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carlsen', 'Affiliation': '99th MDG, Nellis Air Force Base, NV, 89191, USA.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Sharon', 'Affiliation': 'San Antonio, TX, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Crawford', 'Affiliation': '99th MDG, Nellis Air Force Base, NV, 89191, USA. Electronic address: drpaulcrawford@aol.com.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2020.08.006']
2691,32892655,"A bioequivalence study of two telmisartan 80 mg tablets in healthy Indonesian subjects: an open label, three-way, three-period, partial replicate crossover study.","Telmisartan is highly variable drug indicated for treatment of hypertension. This study aimed to compare the bioavailability of two 80 mg telmisartan tablets in healthy Indonesian subjects. A randomized, open-label, single-dose, three-sequence, three-way, reference-formulation-replicated crossover study was conducted under fasting period with two-week washout period. In this study, 31 Indonesian subjects were enrolled and 28 subjects were completed the study. Serial blood samples were collected up to 72 h following drug administration. Plasma concentrations of telmisartan were determined using high-performance liquid chromatography method with fluorescence detector. The pharmacokinetic parameters of AUC 0- t , AUC 0-∞ , and C max were assessed for bioequivalence. Bioequivalence acceptance was based on predefined criteria of 90% confidence interval (CI) of 80.00-125.00% for AUC parameters and reference-scaled-average bioequivalence of 71.73-139.42% for C max . The 90% CI for AUC 0- t , AUC 0-∞ , and C max was 96.11-107.25%, 93.06-104.36%, and 94.23-127.01%, respectively. These results indicated that the two formulations of telmisartan were bioequivalent.",2020,Bioequivalence acceptance was based on predefined criteria of 90% confidence interval of 80.00-125.00% for AUC parameters and reference-scaled-average bioequivalence of 71.73-139.42% for C max .,"['healthy Indonesian subjects', 'Healthy Indonesian Subjects', 'thirty-one Indonesian subjects were enrolled and twenty-eight subjects were completed the study']","['telmisartan', 'telmisartan tablets', 'Telmisartan', 'Two Telmisartan']","['Bioequivalence acceptance', 'pharmacokinetic parameters of AUC 0-t , AUC 0-∞ , and C max', 'Plasma concentrations of telmisartan']","[{'cui': 'C0021248', 'cui_str': 'Indonesian language'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C1248097', 'cui_str': 'telmisartan Oral Tablet'}]","[{'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}]",31.0,0.0241416,Bioequivalence acceptance was based on predefined criteria of 90% confidence interval of 80.00-125.00% for AUC parameters and reference-scaled-average bioequivalence of 71.73-139.42% for C max .,"[{'ForeName': 'Asti Swari', 'Initials': 'AS', 'LastName': 'Paramanindita', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Yahdiana', 'Initials': 'Y', 'LastName': 'Harahap', 'Affiliation': 'Faculty of Pharmacy, University of Indonesia, Depok, Indonesia.'}, {'ForeName': 'Budi', 'Initials': 'B', 'LastName': 'Prasaja', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Tri Rahayu', 'Initials': 'TR', 'LastName': 'Wijayanti', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Windy', 'Initials': 'W', 'LastName': 'Lusthom', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Raden Efi', 'Initials': 'RE', 'LastName': 'Sofiah', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Sandra', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Yunia', 'Initials': 'Y', 'LastName': 'Trisari', 'Affiliation': 'P.T. Novell Pharmaceutical Laboratories, Jakarta, Indonesia.'}]",Drug development and industrial pharmacy,['10.1080/03639045.2020.1820042']
2692,32901672,"Aprepitant plus palonosetron for the prevention of postoperative nausea and vomiting after breast cancer surgery: a double blind, randomized trial.","OBJECTIVES
To evaluate the addition of a fourth antiemetic intervention in patients at high risk for postoperative nausea and vomiting (PONV).
METHODS
High-risk patients (Apfel score 3 or 4) scheduled for unilateral mastectomy were randomly allocated in one of two groups, oral aprepitant (oral aprepitant 80 mg, intravenous dexamethasone 8 mg, and palonosetron 0.075 mg) and oral placebo (oral placebo, intravenous dexamethasone 4 mg, and palonosetron 0.075 mg). Patients and caregivers were blinded to the group assignments. The primary efficacy endpoints included the incidence of nausea and vomiting, and the secondary endpoints included use of rescue antiemetics during a 48-hour postoperative period. ClinicalTrials.gov: NCT02431286.
RESULTS
One hundred patients were enrolled in this study and 91 were analyzed, 48 in group A and 43 in group P. No patient presented with nausea or vomiting in the first 2 hours after surgery. From the 2nd to the 6th hour, the incidence of PONV was 8.33% in group A and 9.30% in group P. In the first 24 hours, the incidence of PONV was 27.08% in the group A and 20.93% in group P. From the 24th to the 48th hour, the incidence of PONV was 8.33% in group A and 13.95% in group P. There were no statistically significant differences in PONV between groups.
CONCLUSION
The addition of aprepitant as a third antiemetic resulted in no significant reduction in the incidence of PONV in this population. However, the incidence of PONV was reduced in relation to the general population.",2020,The addition of aprepitant as a third antiemetic resulted in no significant reduction in the incidence of PONV in this population.,"['One hundred patients were enrolled in this study and 91 were analyzed, 48 in group A and 43 in group', 'High-risk patients (Apfel score 3 or 4) scheduled for unilateral mastectomy', 'patients at high risk for postoperative nausea and vomiting (PONV', 'after breast cancer surgery']","['oral aprepitant (oral aprepitant 80 mg, intravenous dexamethasone 8 mg, and palonosetron 0.075 mg) and oral placebo (oral placebo, intravenous dexamethasone 4 mg, and palonosetron 0.075 mg', 'Aprepitant plus palonosetron', 'antiemetic intervention']","['postoperative nausea and vomiting', 'PONV', 'incidence of nausea and vomiting, and the secondary endpoints included use of rescue antiemetics during a 48-hour postoperative period', 'incidence of PONV', 'nausea or vomiting']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0024886', 'cui_str': 'Simple mastectomy'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C1331021', 'cui_str': 'aprepitant 80 MG'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C4517416', 'cui_str': '0.075'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0985346', 'cui_str': 'Dexamethasone 4 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",100.0,0.25619,The addition of aprepitant as a third antiemetic resulted in no significant reduction in the incidence of PONV in this population.,"[{'ForeName': 'Thiago Ramos', 'Initials': 'TR', 'LastName': 'Grigio', 'Affiliation': 'Anestesia, Instituto do Cancer do Estado de Sao Paulo (ICESP), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Angela Maria', 'Initials': 'AM', 'LastName': 'Sousa', 'Affiliation': 'Anestesia, Instituto do Cancer do Estado de Sao Paulo (ICESP), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Gabriel Guimarães Nunes', 'Initials': 'GGN', 'LastName': 'Magalhães', 'Affiliation': 'Campus Darcy Ribeiro, Faculdade Medicina, Universidade de Brasilia, Brasilia, DF, BR.'}, {'ForeName': 'Hazem Adel', 'Initials': 'HA', 'LastName': 'Ashmawi', 'Affiliation': 'Anestesiologia Experimental LIM-08, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Joaquim Edson', 'Initials': 'JE', 'LastName': 'Vieira', 'Affiliation': 'Cirurgia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e1688']
2693,32914914,"Efficacy of bismuth-based quadruple therapy for eradication of Helicobacter pylori infection based on previous antibiotic exposure: A large-scale prospective, single-center clinical trial in China.","OBJECTIVE
This study aims to evaluate the efficacy and safety of three bismuth-based quadruple regimens for eradication of Helicobacter pylori (H pylori) infection in a large number of H pylori-positive patients with or without previous eradication therapy.
METHODS
Consecutive adult patients with H pylori infection, regardless of previous eradication therapy, were eligible for the present study. Three bismuth-based quadruple regimens were selected according to the past history of antibiotics use: (A) esomeprazole, amoxicillin, clarithromycin, and colloidal bismuth tartrate; (B) esomeprazole, amoxicillin, furazolidone, and colloidal bismuth tartrate; and (C) esomeprazole, doxycycline, furazolidone, and colloidal bismuth tartrate. All patients received a 14-day course of treatment, and 13 C/ 14 C urea breath test was utilized at four weeks after the completion of treatment to determine the H pylori eradication. Then, the eradication rates were calculated in terms of intention-to-treat (ITT) and per-protocol (PP) analyses. Adverse events (AEs) were recorded during the treatment.
RESULTS
Overall, 1,226 patients were recruited, and 331, 57, and 838 patients were allocated to receive regimens A, B, and C, respectively. The H pylori eradication rates were 84.0%, 82.5%, and 82.9% (ITT) and 94.6%, 92.2%, and 93.7% (PP), respectively, in regimens A, B, and C. However, there was no significant difference among these three regimens. The incidence of AEs was 4.6% for all patients during the study, that is, 3.3%, 10.5%, and 4.7% for regimens A, B, and C, respectively. All AEs were mild and recovered at the follow-up visit.
CONCLUSION
All three bismuth-based quadruple regimens based on the previous antibiotic use can achieve satisfactory eradication rates for H pylori infection and are safe.",2020,"The H pylori eradication rates were 84.0%, 82.5%, and 82.9% (ITT) and 94.6%, 92.2%, and 93.7% (PP), respectively, in regimens A, B, and C.","['Consecutive adult patients with H pylori infection, regardless of previous eradication therapy, were eligible for the present study', 'H pylori-positive patients with or without previous eradication therapy', '1,226 patients were recruited, and 331, 57, and 838 patients']","['esomeprazole, amoxicillin, clarithromycin, and colloidal bismuth tartrate; (B) esomeprazole, amoxicillin, furazolidone, and colloidal bismuth tartrate; and (C) esomeprazole, doxycycline, furazolidone, and colloidal bismuth tartrate', 'bismuth-based quadruple therapy', 'bismuth-based quadruple regimens']","['incidence of AEs', 'Helicobacter pylori infection', 'eradication rates', 'efficacy and safety', 'Helicobacter pylori (H pylori) infection', 'Adverse events (AEs', 'H pylori eradication rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0053781', 'cui_str': 'bismoverol'}, {'cui': 'C0016855', 'cui_str': 'Furazolidone'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1226.0,0.0323817,"The H pylori eradication rates were 84.0%, 82.5%, and 82.9% (ITT) and 94.6%, 92.2%, and 93.7% (PP), respectively, in regimens A, B, and C.","[{'ForeName': 'Jing-Jing', 'Initials': 'JJ', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Shao-Peng', 'Initials': 'SP', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Cai', 'Affiliation': 'Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China.'}]",Helicobacter,['10.1111/hel.12755']
2694,32877722,Characteristics of contents in the upper gastrointestinal lumen after a standard high-calorie high-fat meal and implications for the in vitro drug product performance testing conditions.,"OBJECTIVES
To measure the pH, buffer capacity, lipid content, bile acid content, and viscosity in the upper gastrointestinal (GI) lumen after a standard high-calorie, high-fat meal as well as the osmolality, lipid content and bile acid content in the aqueous phase of the gastric contents and the micellar phase of contents of the upper small intestine. To evaluate the implications of these findings for the composition of biorelevant media employed in vitro oral drug product performance testing representing the upper GI conditions after ingestion of the standard meal.
METHODS
Eight healthy male adult volunteers participated in a two-phase, crossover study in which a homogenized standard meal was administered to the antrum via the gastric port of a naso-gastro-intestinal tube. A glass of tap water and single paracetamol and danazol doses were administered to the antrum of the stomach 30 min after the initiation of meal administration (Pentafragka et al., 2020). Samples were aspirated from the antrum and the upper small intestine over the next four hours. The pH and the buffer capacity of the samples were measured immediately upon aspiration, while viscosity, osmolality, and presence of solubilizing agents were measured after storage at -70 °C.
RESULTS
The composition of gastric contents over time fluctuated less after the homogenized standard meal than after liquid meals with similar composition. Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low. Mean viscosity values in the stomach at 100 s -1 were 80-800 times higher than in the fasted state for more than 3 h after the standard meal. In the upper small intestine, mean viscosity values at 100 s -1 were at least 100 times higher than in the fasted state for 4 h after the standard meal.
CONCLUSIONS
Based on data collected in this study, Level I and Level II biorelevant media simulating the intragastric conditions after ingestion of a standard meal could be simplified whereas FeSSIF-V2 composition was confirmed to be representative of the composition of contents in the upper small intestine. Representative values of viscosity in the stomach and the upper small intestine and Level II composition of the aqueous phase of gastric contents, after the standard meal, are proposed for first time.",2020,Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low.,['Eight healthy male adult volunteers'],"['homogenized standard meal', 'paracetamol and danazol']","['Mean viscosity values', 'mean viscosity values', 'viscosity, osmolality, and presence of solubilizing agents', 'pH, buffer capacity, lipid content, bile acid content, and viscosity in the upper gastrointestinal (GI) lumen']","[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0444664', 'cui_str': 'Standard meal'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}]",8.0,0.0385476,Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pentafragka', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vertzoni', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dressman', 'Affiliation': 'Goethe University, Frankfurt/Main, Germany.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Symillides', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Goumas', 'Affiliation': 'Department of Gastroenterology, Red Cross Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Reppas', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece. Electronic address: reppas@pharm.uoa.gr.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105535']
2695,32877791,"Parents as Teachers: Mothers' Roles in Sexual Abuse Prevention Education in Gorgan, Iran.","BACKGROUND
Parents play an important role in protecting their children from sexual abuse. Mothers, in particular, play key roles in the sexual socialization of their children and in educating their children about child sexual abuse (CSA).
OBJECTIVES
The purpose of this study was to determine whether preschool girls in Gorgan (a city in northern Iran) could learn personal safety skills when taught by their mothers.
PARTICIPANTS AND SETTING
Fifty-six participants (mother-daughter pairs) were recruited from patients visiting health centers. Mean age of girls was 6.34 years.
METHODS
Girls were pretested using Persian versions of the Personal Safety Questionnaire and 'What If' Situations Test, randomly assigned to either a mother-taught program or wait-list control, and post-tested. Mothers assigned to the education group participated in a two-hour workshop on preventing CSA and were given the Body Safety Training workbook to teach their daughters. Following the one-week training by their mothers, children in both groups were post-tested and follow-up tested one month later.
RESULTS
Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
CONCLUSION
Results suggest that mothers can effectively teach their young daughters personal safety skills. Difficulties female children have in recognizing appropriate-touch requests are discussed and compared to results in other developing countries. Advantages of home-based instruction for young children are described and suggestions for increasing parent participation are offered.",2020,"RESULTS
Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
","[""Mothers' Roles in Sexual Abuse Prevention Education in Gorgan, Iran"", 'Mean age of girls was 6.34 years', 'Difficulties female children', 'Fifty-six participants (mother-daughter pairs) were recruited from patients visiting health centers', 'young children', 'Parents as Teachers', 'Girls', 'preschool girls in Gorgan (a city in northern Iran']","['home-based instruction', 'mother-taught program or wait-list control, and post-tested']",['knowledge about sexual abuse and higher levels of personal safety skills'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C1633748', 'cui_str': 'Prevention education'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",56.0,0.0148705,"RESULTS
Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Khoori', 'Affiliation': 'Counselling and Reproductive Health Research Centre, Golestan University of Medical Sciences, Gorgan, Iran. Electronic address: elhamkhoori@yahoo.com.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Gholamfarkhani', 'Affiliation': 'Department of Obstetrics and Gynecology, Shohada Hospital of Quchan, Mashhad University of Medical Sciences, Quchan, Iran. Electronic address: somayeh.farkhani@gmail.com.'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Tatari', 'Affiliation': 'Counselling and Reproductive Health Research Centre, Golestan University of Medical Sciences, Gorgan, Iran. Electronic address: maisa.tatari@yahoo.com.'}, {'ForeName': 'Sandy K', 'Initials': 'SK', 'LastName': 'Wurtele', 'Affiliation': 'Department of Psychology, University of Colorado, Colorado Springs, USA. Electronic address: swurtele@uccs.edu.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104695']
2696,32878112,Effect of a Graduated Walking Program on the Severity of Obstructive Sleep Apnea Syndrome. A Randomized Clinical Trial.,"BACKGROUND
Obstructive sleep apnea syndrome (OSAS) is a common disease. The objective of this research was to determine the effectiveness of a graduated walking program in reducing the apnea-hypopnea index number in patients with obstructive sleep apnea syndrome (OSAS).
METHODS
A randomized controlled clinical trial with a two-arm parallel in three tertiary hospitals was carried out with seventy sedentary patients with moderate to severe OSAS. Twenty-nine subjects in each arm were analyzed by protocol. The control group received usual care, while usual care and an exercise program based on progressive walks without direct supervision for 6 months were offered to the intervention group.
RESULTS
The apnea-hypopnea index decreased by six points in the intervention group, and improvements in oxygen desaturation index, total cholesterol, and Low-Density Lipoprotein of Cholesterol (LDL-c) were observed. A higher decrease in sleep apnea-hypopnea index (45 ± 20.6 vs. 34 ± 26.3/h; p = 0.002) was found in patients with severe vs. moderate OSAS, as well as in oxygen desaturation index from baseline values (43.3 vs. 34.3/h; p = 0.046). Besides, High-Density Lipoprotein of Cholesterol (HDL-c) values showed a higher increase in the intervention group (45.3 vs. 49.5 mg/dL; p = 0.009) and also, a higher decrease in LDL-c was found in this group (141.2 vs. 127.5 mg/dL; p = 0.038).
CONCLUSION
A home physical exercise program is a useful and viable therapeutic measure for the management of OSAS.",2020,"The apnea-hypopnea index decreased by six points in the intervention group, and improvements in oxygen desaturation index, total cholesterol, and Low-Density Lipoprotein of Cholesterol (LDL-c) were observed.","['seventy sedentary patients with moderate to severe OSAS', 'Obstructive sleep apnea syndrome (OSAS', 'patients with obstructive sleep apnea syndrome (OSAS']","['graduated walking program', 'home physical exercise program', 'Graduated Walking Program', 'usual care, while usual care and an exercise program based on progressive walks without direct supervision']","['sleep apnea-hypopnea index', 'apnea-hypopnea index number', 'High-Density Lipoprotein of Cholesterol (HDL-c) values', 'LDL-c', 'oxygen desaturation index, total cholesterol, and Low-Density Lipoprotein of Cholesterol (LDL-c', 'oxygen desaturation index', 'apnea-hypopnea index', 'Severity of Obstructive Sleep Apnea Syndrome']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",70.0,0.0195596,"The apnea-hypopnea index decreased by six points in the intervention group, and improvements in oxygen desaturation index, total cholesterol, and Low-Density Lipoprotein of Cholesterol (LDL-c) were observed.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Jurado-García', 'Affiliation': 'Department of Physiotherapy, San Juan de Dios Hospital Cordoba, 14012 Cordoba, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Molina-Recio', 'Affiliation': 'Department of Nursing, Faculty of Medicine and Nursing, University of Cordoba, 14004 Cordoba, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Feu-Collado', 'Affiliation': 'Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Pneumology Department, Reina Sofia University Hospital, University of Cordoba, 14004 Cordoba, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Palomares-Muriana', 'Affiliation': 'Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Pneumology Department, Reina Sofia University Hospital, University of Cordoba, 14004 Cordoba, Spain.'}, {'ForeName': 'Adela María', 'Initials': 'AM', 'LastName': 'Gómez-González', 'Affiliation': 'Cardiopulmonary Rehabilitation Department, Virgen de la Victoria University Hospital, 29010 Malaga, Spain.'}, {'ForeName': 'Francisca Lourdes', 'Initials': 'FL', 'LastName': 'Márquez-Pérez', 'Affiliation': 'Pneumology Department, University Hospital of Badajoz, 06005 Badajoz, Spain.'}, {'ForeName': 'Bernabé', 'Initials': 'B', 'LastName': 'Jurado-Gamez', 'Affiliation': 'Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Pneumology Department, Reina Sofia University Hospital, University of Cordoba, 14004 Cordoba, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17176334']
2697,32878899,"Cost-effectiveness analysis of tranexamic acid for the treatment of traumatic brain injury, based on the results of the CRASH-3 randomised trial: a decision modelling approach.","INTRODUCTION
An estimated 69 million traumatic brain injuries (TBI) occur each year worldwide, with most in low-income and middle-income countries. The CRASH-3 randomised trial found that intravenous administration of tranexamic acid within 3 hours of injury reduces head injury deaths in patients sustaining a mild or moderate TBI. We examined the cost-effectiveness of tranexamic acid treatment for TBI.
METHODS
A Markov decision model was developed to assess the cost-effectiveness of treatment with and without tranexamic acid, in addition to current practice. We modelled the decision in the UK and Pakistan from a health service perspective, over a lifetime time horizon. We used data from the CRASH-3 trial for the risk of death during the trial period (28 days) and patient quality of life, and data from the literature to estimate costs and long-term outcomes post-TBI. We present outcomes as quality-adjusted life years (QALYs) and 2018 costs in pounds for the UK, and US dollars for Pakistan. Incremental cost-effectiveness ratios (ICER) per QALY gained were estimated, and compared with country specific cost-effective thresholds. Deterministic and probabilistic sensitivity analyses were also performed.
RESULTS
Tranexamic acid was highly cost-effective for patients with mild TBI and intracranial bleeding or patients with moderate TBI, at £4288 per QALY in the UK, and US$24 per QALY in Pakistan. Tranexamic acid was 99% and 98% cost-effective at the cost-effectiveness thresholds for the UK and Pakistan, respectively, and remained cost-effective across all deterministic sensitivity analyses. Tranexamic acid was even more cost-effective with earlier treatment administration. The cost-effectiveness for those with severe TBI was uncertain.
CONCLUSION
Early administration of tranexamic acid is highly cost-effective for patients with mild or moderate TBI in the UK and Pakistan, relative to the cost-effectiveness thresholds used. The estimated ICERs suggest treatment is likely to be cost-effective across all income settings globally.",2020,"RESULTS
Tranexamic acid was highly cost-effective for patients with mild TBI and intracranial bleeding or patients with moderate TBI, at £4288 per QALY in the UK, and US$24 per QALY in Pakistan.","['patients sustaining a mild or moderate TBI', 'patients with mild or moderate TBI in the UK and Pakistan', 'traumatic brain injury']","['tranexamic acid', 'Tranexamic acid']","['cost-effectiveness', 'quality-adjusted life years (QALYs) and 2018 costs in pounds for the UK, and US dollars for Pakistan', 'cost-effective', 'head injury deaths', 'Incremental cost-effectiveness ratios (ICER) per QALY']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018674', 'cui_str': 'Injury of head'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0979185,"RESULTS
Tranexamic acid was highly cost-effective for patients with mild TBI and intracranial bleeding or patients with moderate TBI, at £4288 per QALY in the UK, and US$24 per QALY in Pakistan.","[{'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK Jack.Williams@lshtm.ac.uk.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Haleema', 'Initials': 'H', 'LastName': 'Shakur-Still', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Fiona E', 'Initials': 'FE', 'LastName': 'Lecky', 'Affiliation': 'Centre for Urgent and Emergency Care Research, School of Health and Related Research, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Rizwana', 'Initials': 'R', 'LastName': 'Chaudhri', 'Affiliation': 'Holy Family Hospital, Rawalpindi Medical University, Rawalpindi, Pakistan.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'Miners', 'Affiliation': 'Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}]",BMJ global health,['10.1136/bmjgh-2020-002716']
2698,32886192,Impact of a comprehensive digital health programme on HbA 1c and weight after 12 months for people with diabetes and prediabetes: a randomised controlled trial.,"AIMS/HYPOTHESIS
The aim of this RCT was to evaluate the effectiveness of a digital health programme (BetaMe/Melon) vs usual care in improving the control of type 2 diabetes and prediabetes in a primary care population.
METHODS
We conducted a randomised parallel-group two-arm single-blinded superiority trial in the primary care setting in two regions of New Zealand. Eligible participants were identified through Primary Health Organisations and participating practices. Eligibility criteria were as follows: age 18-75 years, HbA 1c 41-70 mmol/mol (5.9-8.6%), not taking insulin, and daily access to the internet. BetaMe/Melon is a 12 month mobile-device and web-based programme with four components: health coaching; evidence-based resources; peer support; and goal tracking. Participants were randomised into the intervention or control arm (1:1 allocation) based upon baseline HbA 1c (prediabetes or diabetes range), stratified by practice and ethnicity. Research nurses and the study biostatistician were blind to study arm. Primary outcomes of the study were changes in HbA 1c and weight at 12 months, using an intention-to-treat analysis.
RESULTS
Four hundred and twenty-nine individuals were recruited between 20 June 2017 and 11 May 2018 (n = 215 intervention arm, n = 214 control arm), most of whom were included in analyses of co-primary outcomes (n = 210/215, 97.7% and n = 213/214, 99.5%). HbA 1c levels at 12 months did not differ between study arms: mean difference was -0.9 mmol/mol (95% CI -2.9, 1.1) (-0.1% [95% CI -0.3, 0.1]) for the diabetes group and was 0.0 mmol/mol (95% CI -0.9, 0.9) (0.0% [95% CI -0.1, 0.1]) for the prediabetes group. Weight reduced slightly at 12 months for participants in both study arms, with no difference between arms (mean difference -0.4 kg [95% CI -1.3, 0.5]).
CONCLUSIONS/INTERPRETATION
This study did not demonstrate clinical effectiveness for this particular programme. Given their high costs, technology-assisted self-management programmes need to be individually assessed for their effectiveness in improving clinical outcomes for people with diabetes.
TRIAL REGISTRATION
www.anzctr.org.au ACTRN12617000549325 (universal trial number U1111-1189-9094) FUNDING: This study was funded by the Health Research Council of New Zealand, the Ministry of Health New Zealand and the Healthier Lives National Science Challenge. Graphical abstract.",2020,"Weight reduced slightly at 12 months for participants in both study arms, with no difference between arms (mean difference -0.4 kg [95% CI -1.3, 0.5]).
","['Four hundred and twenty-nine individuals were recruited between 20 June 2017 and 11 May 2018 (n\u2009=\u2009215 intervention arm, n\u2009=\u2009214 control arm), most of whom were included in analyses of co-primary outcomes (n\u2009=\u2009210/215, 97.7% and n\u2009=\u2009213/214, 99.5', 'primary care setting in two regions of New Zealand', 'Eligibility criteria were as follows: age 18-75\xa0years, HbA 1c 41-70\xa0mmol/mol (5.9-8.6%), not taking insulin, and daily access to the internet', 'Eligible participants were identified through Primary Health Organisations and participating practices', 'people with diabetes', 'people with diabetes and prediabetes']","['comprehensive digital health programme', 'intervention or control arm (1:1 allocation) based upon baseline HbA 1c (prediabetes or diabetes range', 'RCT', 'BetaMe', 'digital health programme (BetaMe/Melon) vs usual care']","['HbA 1c levels', 'HbA 1c and weight', 'Weight', 'changes in HbA 1c and weight at 12\xa0months, using an intention-to-treat analysis']","[{'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4517912', 'cui_str': '99.5'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0454766', 'cui_str': 'Regions of New Zealand'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0440285', 'cui_str': 'Melon'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]",429.0,0.326558,"Weight reduced slightly at 12 months for participants in both study arms, with no difference between arms (mean difference -0.4 kg [95% CI -1.3, 0.5]).
","[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'McLeod', 'Affiliation': 'Department of Public Health, University of Otago, Wellington, New Zealand. melissa.mcleod@otago.ac.nz.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Stanley', 'Affiliation': 'Department of Public Health, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Signal', 'Affiliation': 'Department of Public Health, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Jeannine', 'Initials': 'J', 'LastName': 'Stairmand', 'Affiliation': 'Department of Public Health, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department of Public Health, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Henderson', 'Affiliation': 'Department of Public Health, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Davies', 'Affiliation': 'Kokiri Marae, Seaview, Wellington, New Zealand.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Krebs', 'Affiliation': 'Department of Medicine, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Dowell', 'Affiliation': 'Department Primary Health Care and General Practice, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Grainger', 'Affiliation': 'Department of Medicine, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Sarfati', 'Affiliation': 'Department of Public Health, University of Otago, Wellington, New Zealand.'}]",Diabetologia,['10.1007/s00125-020-05261-x']
2699,32881761,The Effects of Sensory Enrichment After a Laboratory Stressor on Human Skin Barrier Recovery in a Randomized Trial.,"OBJECTIVE
Environmental enrichment (EE) can reduce stress, alter immunity, and speed wound healing in animals. However, it is not known whether these effects translate to humans. This study aimed to investigate whether sensory EE could improve wound healing after a stressor in humans.
METHODS
A total of 105 participants underwent a tape-stripping procedure and were then stressed using a laboratory stress paradigm. After this, they were randomized to interact for 30 minutes with one of two possible sensory EE interventions (music as auditory enrichment or a Paro robot as multisensory enrichment) or to a control condition. Skin barrier recovery was measured using transepidermal water loss at baseline, after the stressor, and after the intervention. Stress was measured using self-report, heart rate, blood pressure, and salivary stress-related biological measures. Enjoyment during the intervention was measured by self-report as a possible mediator.
RESULTS
The Paro condition had significantly improved skin barrier recovery (mean [M] = 44%, standard error [SE] = 1.92) compared with the control condition (M = 37% SE = 2.01, F(2,88) = 3.25, p = .043), both with and without controlling for covariates. The music condition did not significantly differ from the other conditions (M = 42%, SE = 1.95, p values > .05). Both objective and subjective stress measures did not significantly differ between conditions. Mediational analysis showed that enjoyment levels during the intervention period significantly mediated the relationship between condition and skin barrier recovery (z = 2.00, p = .046).
CONCLUSIONS
Paro, or other companion robots, may be an effective form of enrichment to improve skin barrier recovery in humans after a laboratory stressor, and this effect may be due to enjoyment. Further research with patient groups is required to investigate whether Paro can help heal clinical wounds.
TRIAL REGISTRATION
ACTRN12618000953235, registered at https://anzctr.org.au.",2020,"The Paro condition had significantly improved skin barrier recovery (M=44%, SE=1.92) compared to the control condition (M=37% SE=2.01, F(2,88)=3.25, p=.043), both with and without controlling for covariates.","['105 participants underwent a', 'animals', 'humans']","['tape-stripping procedure', 'sensory EE interventions (music as auditory enrichment or a Paro robot as multi-sensory enrichment', 'sensory enrichment after a laboratory stressor', 'Environmental enrichment (EE', 'sensory EE']","['subjective stress measures', 'skin barrier recovery', 'transepidermal water loss', 'condition and skin barrier recovery', 'self-report, heart rate, blood pressure and salivary stress-related biological measures', 'wound healing', 'enjoyment levels', 'Skin barrier recovery']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",105.0,0.0594352,"The Paro condition had significantly improved skin barrier recovery (M=44%, SE=1.92) compared to the control condition (M=37% SE=2.01, F(2,88)=3.25, p=.043), both with and without controlling for covariates.","[{'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Law', 'Affiliation': 'From the Department of Psychological Medicine (Law, Broadbent), The University of Auckland; Department of Dermatology (Jarrett), Middlemore Hospital; Department of Medicine (Jarrett), The University of Auckland, Auckland, New Zealand; and Faculty of Psychology (Nater, Skoluda), University of Vienna, Vienna, Austria.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Jarrett', 'Affiliation': ''}, {'ForeName': 'Urs M', 'Initials': 'UM', 'LastName': 'Nater', 'Affiliation': ''}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Skoluda', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Broadbent', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000858']
2700,32883044,Physical Activity and Physical Competence in Overweight and Obese Children: An Intervention Study.,"With the current obesity epidemic and the decline of fitness among school-aged children, the importance of obesity interventions to promote physical activity and healthy habits has become indisputable. The purpose of this study was to assess the efficacy of a school-based multicomponent intervention in increasing physical activity (PA) levels, actual physical abilities, and perceived physical abilities in clinical and nonclinical samples of overweight/obese boys and girls aged 10-12 years. The clinical intervention group ( n = 35) participated in a 7-month after-school program in addition to curricular physical education lessons, while the nonclinical control group ( n = 29) received usual curricular lessons. Measures included levels of PA and fitness and individual's perceptions of physical ability. After treatment, the intervention group showed improved PA levels, perceived physical ability, and throwing and jumping task performances compared to the control group. Results indicate that a multicomponent program can improve levels of PA, fitness, and perceived competence of overweight participants. Findings highlight the importance of a comprehensive healthy lifestyle program that includes physical, psychosocial, and behavioral factors and suggest practical implications for educators, trainers, and teachers in identifying best practices targeting childhood obesity.",2020,"After treatment, the intervention group showed improved PA levels, perceived physical ability, and throwing and jumping task performances compared to the control group.","['school-aged children', 'Overweight and Obese Children', 'overweight/obese boys and girls aged 10-12 years']","['7-month after-school program in addition to curricular physical education lessons, while the nonclinical control group ( n = 29) received usual curricular lessons', 'school-based multicomponent intervention']","['PA levels, perceived physical ability, and throwing and jumping task performances', 'physical activity (PA) levels, actual physical abilities, and perceived physical abilities', 'levels of PA, fitness, and perceived competence of overweight participants', 'Physical Activity and Physical Competence', ""levels of PA and fitness and individual's perceptions of physical ability""]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",35.0,0.0145829,"After treatment, the intervention group showed improved PA levels, perceived physical ability, and throwing and jumping task performances compared to the control group.","[{'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Morano', 'Affiliation': 'Parisi-De Sanctis Institute, MIUR (Italian Ministry of Education, University and Research), 71121 Foggia, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Robazza', 'Affiliation': 'BIND-Behavioral Imaging and Neural Dynamics Center, Department of Medicine and Aging Sciences, ""G. d\'Annunzio"" University of Chieti-Pescara, 66013 Chieti, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bortoli', 'Affiliation': 'BIND-Behavioral Imaging and Neural Dynamics Center, Department of Medicine and Aging Sciences, ""G. d\'Annunzio"" University of Chieti-Pescara, 66013 Chieti, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Rutigliano', 'Affiliation': 'Pediatrics, IRCCS Casa Sollievo della Sofferenza, 71013 San Giovanni Rotondo, Italy.'}, {'ForeName': 'Montse C', 'Initials': 'MC', 'LastName': 'Ruiz', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, 40014 Jyväskylä, Finland.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Campanozzi', 'Affiliation': 'Pediatrics, Department of Medical and Surgical Sciences, University of Foggia, 71122 Foggia, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17176370']
2701,32886566,"Health Department Efforts to Increase Hepatitis C RNA Testing Among People Appearing Out of Care: Comparison of Outreach Approaches, New York City, 2017.","OBJECTIVES
Hepatitis C virus (HCV) infection is a serious health problem in New York City. Although curative treatments are available, many people are out of care. The New York City Department of Health and Mental Hygiene (DOHMH) used surveillance data and various outreach methods to attempt to link to care people diagnosed with HCV infection from 2010 through 2015.
METHODS
We randomly assigned people out of care (ie, no HCV test >6 months after first report) to 4 outreach groups: no outreach (control group); letter only; letter and telephone call; and letter, text message, and telephone call. Three months after outreach ended, we analyzed surveillance data to identify people with a subsequent HCV RNA or genotype test suggesting linkage to care.
RESULTS
Of 2626 selected people, 199 (7.6%) had a subsequent HCV test. People in all 3 outreach groups had higher odds of a subsequent test than people in the control group (letter only: adjusted odds ratio [aOR] = 1.81 [95% CI, 1.18-2.91]; letter and telephone: aOR = 3.11 [95% CI, 1.67-5.79]; letter, text, and telephone: aOR = 3.17 [95% CI, 1.48-6.51]). People in the letter and telephone group had higher odds of a subsequent test than people in the letter-only group (aOR = 1.72; 95% CI, 1.04-2.74). Most people in the letter and telephone (136/200, 68.0%) and the letter, text, and telephone (71/99, 71.7%) groups could not be reached, primarily because telephone numbers were incorrect or out of service.
CONCLUSION
Reaching out to people soon after first report or prioritizing groups in which more recent contact information can be found might improve outcomes of future outreach.",2020,"People in all 3 outreach groups had higher odds of a subsequent test than people in the control group (letter only: adjusted odds ratio [aOR] = 1.81 [95% CI, 1.18-2.91]; letter and telephone: aOR = 3.11 [95% CI, 1.67-5.79]; letter, text, and telephone: aOR = 3.17 [95% CI, 1.48-6.51]).","['Of 2626 selected people, 199 (7.6%) had a subsequent HCV test', 'care people diagnosed with HCV infection from 2010 through 2015', 'People Appearing Out of Care']","['care (ie, no HCV test >6 months after first report) to 4 outreach groups: no outreach (control group); letter only; letter and telephone call; and letter, text message, and telephone call']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2363789', 'cui_str': 'Hepatitis C virus test'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]","[{'cui': 'C2363789', 'cui_str': 'Hepatitis C virus test'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",[],2626.0,0.0827249,"People in all 3 outreach groups had higher odds of a subsequent test than people in the control group (letter only: adjusted odds ratio [aOR] = 1.81 [95% CI, 1.18-2.91]; letter and telephone: aOR = 3.11 [95% CI, 1.67-5.79]; letter, text, and telephone: aOR = 3.17 [95% CI, 1.48-6.51]).","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Webster', 'Affiliation': '364931 New York City Department of Health and Mental Hygiene, Bureau of Communicable Disease, Division of Disease Control, Viral Hepatitis Program, Queens, NY, USA.'}, {'ForeName': 'Miranda S', 'Initials': 'MS', 'LastName': 'Moore', 'Affiliation': '364931 New York City Department of Health and Mental Hygiene, Bureau of Communicable Disease, Division of Disease Control, Viral Hepatitis Program, Queens, NY, USA.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Bocour', 'Affiliation': '364931 New York City Department of Health and Mental Hygiene, Bureau of Communicable Disease, Division of Disease Control, Viral Hepatitis Program, Queens, NY, USA.'}, {'ForeName': 'Nirah', 'Initials': 'N', 'LastName': 'Johnson', 'Affiliation': '364931 New York City Department of Health and Mental Hygiene, Bureau of Communicable Disease, Division of Disease Control, Viral Hepatitis Program, Queens, NY, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Winters', 'Affiliation': '364931 New York City Department of Health and Mental Hygiene, Bureau of Communicable Disease, Division of Disease Control, Viral Hepatitis Program, Queens, NY, USA.'}]","Public health reports (Washington, D.C. : 1974)",['10.1177/0033354920952068']
2702,32890814,Did young women in South African informal settlements display increased agency after participating in the Stepping Stones and Creating Futures intervention? A qualitative evaluation.,"This paper investigates the impact of the Stepping Stones Creating Futures (SSCF) intervention on young women in informal settlements in eThekwini, South Africa. Specifically, whether following participation in the intervention the young women experienced a reduction in intimate partner violence, strengthened agency and shifted gender relations. Where changes occurred, it examines how they occurred, and barriers and enablers to change. SSCF is a gender transformative and livelihoods strengthening intervention using participatory, reflective small groups. Qualitative research was undertaken with fifteen women participating in the SSCF randomised control trial between 2015 and 2018. The women were followed over 18 months, participating in in-depth interviews at baseline, 12- and 18-months post intervention. To supplement these, eight women were involved in Photovoice work at baseline and 18 months and seven were included in ongoing participant observation. Data were analysed inductively. Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods. Despite these important shifts many women did not report a reduction in IPV. Nonetheless we argue most of the women, following the intervention, became more agentic. Drawing on the notion of 'distributed agency' as developed by Campbell and Mannell (2016), we show that SSCF bolstered the women's distributed agency. Distributed agency recognizes small agentic acts that women take, acts which to them are significant, it further notes that agency is temporal, fluid, dynamic and context specific. Women do not 'either have agency or not', rather being agentic depends on time, context and the particular incident. These findings provide an important contribution to the limited application of distributed agency and femininities work in informal settlements and are critical for policy and intervention science to reduce IPV and support women's agency.",2020,"Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods.","['young women in informal settlements in eThekwini, South Africa', 'fifteen women participating in the SSCF randomised control trial between 2015 and 2018', 'eight women were involved in Photovoice work at baseline and 18 months and seven were included in ongoing participant observation']","['SSCF', 'Stepping Stones Creating Futures (SSCF) intervention']","['communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods', 'intimate partner violence, strengthened agency and shifted gender relations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0558038', 'cui_str': 'Participant observation'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0233894', 'cui_str': 'Femininity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0242360', 'cui_str': 'Relations, Gender'}]",15.0,0.0551815,"Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods.","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Willan', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa. Electronic address: Samantha.willan@mrc.ac.za.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gibbs', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa; Centre for Rural Health, School of Nursing and Public Health, Mazisi Kunene Road, University of KwaZulu-Natal, Durban, 4041, South Africa.'}, {'ForeName': 'Nwabisa', 'Initials': 'N', 'LastName': 'Shai', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Nolwazi', 'Initials': 'N', 'LastName': 'Ntini', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, Mazisi Kunene Road, University of KwaZulu-Natal, Durban, 4041, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jewkes', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113302']
2703,32896753,Proprioceptive neuromuscular facilitation in the functionality and lymphatic circulation of the upper limb of women undergoing breast cancer treatment.,"BACKGROUND
With the increase in survival of women treated for breast cancer, it is necessary to evaluate the effect of therapeutic resources on co-morbidities resulting from the surgical treatment of the disease. The aim of this study was to evaluate the effects of proprioceptive neuromuscular facilitation on the functionality and lymphatic circulation of the upper limb involved in the treatment of breast cancer.
METHODS
The study was conducted according to randomized clinical trial design. Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment, divided into two groups, control - women submitted to standard breast cancer treatment, and treated group, composed of women who underwent breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique. Palmar grip strength with dynamometer and shoulder range of motion with goniometer were evaluated. Lymphatic circulation analysis was performed in a computerized scintillation chamber, before and after therapeutic intervention.
FINDINGS
In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
INTERPRETATION
The results obtained in this study allow us to conclude that proprioceptive neuromuscular facilitation favors an increase in muscle strength, range of motion, but not in lymphatic flow, in women undergoing surgical treatment for breast cancer.",2020,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","['women undergoing surgical treatment for breast cancer', 'women undergoing breast cancer treatment', 'Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment']","['proprioceptive neuromuscular facilitation', 'Proprioceptive neuromuscular facilitation', 'breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique', 'control - women submitted to standard breast cancer treatment']","['muscle strength, range of motion', 'palmar grip strength', 'internal rotation', 'lymphatic flow', 'range of motion of flexion', 'Palmar grip strength with dynamometer and shoulder range of motion with goniometer', 'external rotation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0454481', 'cui_str': 'Proprioceptive neuromuscular facilitation technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0575813', 'cui_str': 'Palmar grip'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}]",32.0,0.0146829,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","[{'ForeName': 'Daniela Santana Polati', 'Initials': 'DSP', 'LastName': 'da Silveira', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil. Electronic address: daniela.silveira@unifran.edu.br.'}, {'ForeName': 'Marcelo José', 'Initials': 'MJ', 'LastName': 'Dos Santos', 'Affiliation': 'Departament of Nuclear Medicine, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Eduardo Tinóis', 'Initials': 'ET', 'LastName': 'da Silva', 'Affiliation': 'Departament of Physics in Nuclear Medicine, Radiation Safety and Technology Institute, Campinas, SP, Brazil.'}, {'ForeName': 'Almir José', 'Initials': 'AJ', 'LastName': 'Sarri', 'Affiliation': 'Departament of Physiotherapy, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Lais Mara Siqueira', 'Initials': 'LMS', 'LastName': 'das Neves', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Elaine Caldeira de Oliveira', 'Initials': 'ECO', 'LastName': 'Guirro', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil; Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil. Electronic address: ecguirro@fmrp.usp.br.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105158']
2704,32896776,The long-term influence of hospital and surgeon volume on local control and survival in the randomized German Rectal Cancer Trial CAO/ARO/AIO-94.,"BACKGROUND
The association of treatment volume and oncological outcome of rectal cancer patients undergoing multidisciplinary treatment is subject of an ongoing debate. Prospective data on long-term local control and overall survival (OS) are not available so far. This study investigated the long-term influence of hospital and surgeon volume on local recurrence (LR) and OS in patients with locally advanced rectal cancers.
METHODS
In a post-hoc analysis of the randomized phase III CAO/ARO/AIO-94 trial after a follow-up of more than 10 years, 799 patients with stage II/III rectal cancers were evaluated. LR-rates and OS were stratified by hospital recruitment volume (≤20 vs. 21-90 vs. >90 patients) and by surgeon volume (≤10 vs. 11-50 vs. >50 procedures).
RESULTS
Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03). The surgeon volume was adversely associated with LR (p = 0.01) but had no influence on overall survival. The positive effect of neoadjuvant chemoradiation (CRT) on local control was the strongest in patients being operated by medium-volume surgeons, less in patients being operated by high-volume surgeons and missing in those being operated by low-volume surgeons.
CONCLUSIONS
Patients with locally advanced rectal cancers might benefit from treatment in specialized high-volume hospitals. In particular, the surgeon volume had significant influence on long-term local tumour control. The effect of neoadjuvant CRT on local tumour control may likewise depend on the surgeon volume.",2020,"RESULTS
Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","['799 patients with stage II/III rectal cancers', 'Patients with locally advanced rectal cancers', 'patients with locally advanced rectal cancers', 'rectal cancer patients undergoing']","['neoadjuvant CRT', 'multidisciplinary treatment', 'neoadjuvant chemoradiation (CRT']","['overall survival (OS', 'LR-rates and OS', 'longer OS', 'long-term local tumour control', 'local control and survival', 'overall survival', 'local recurrence (LR) and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",799.0,0.0971685,"RESULTS
Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","[{'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany. Electronic address: thilo.sprenger@chiru.med.uni-giessen.de.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Beißbarth', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Sauer', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Tschmelitsch', 'Affiliation': 'Department of Surgery, Krankenhaus der Barmherzigen Brüder, St. Veit an der Glan, Austria.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Hohenberger', 'Affiliation': 'Department of Surgery, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Staib', 'Affiliation': 'Department of General and Visceral Surgery, Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'Hans-Rudolf', 'Initials': 'HR', 'LastName': 'Raab', 'Affiliation': 'University Department of General and Visceral Surgery, Klinikum Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'Department of Radiotherapy and Oncology, University Medical Center Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.021']
2705,32898787,"Calorie restriction and synbiotics effect on quality of life and edema reduction in breast cancer-related lymphedema, a clinical trial.","BACKGROUND
Little evidence exists regarding the clinical value of synbiotics in the management of post-treatment complications of breast cancer especially breast cancer-related lymphedema (BCRL). This study aimed to investigate the effects of synbiotic supplementation along with calorie restriction on quality of life and edema volume in patients with BCRL.
METHODS
This randomized, placebo-controlled, clinical trial was conducted on 135 overweight and obese women with BCRL aged 18-65 years old. Participants were randomly allocated to receive a calorie-restricted diet plus 10 9 CFU synbiotic supplement (CRS group; n = 45) or placebo (CRP group; n = 45), daily for 10 weeks. Also, a control group (n = 45) with no intervention was included in the trial. All of the participants received Complete Decongestive Therapy for lymphedema treatment. The quality of life score, edema volume and body mass index (BMI) were measured at baseline and end of the trial.
RESULTS
A total of 121 subjects completed the trial. CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control. However, there were no significant differences in changes in trial outcomes between the CRS and CRP groups.
CONCLUSION
Synbiotic supplementation along with a low-calorie diet was effective in quality of life, edema volume, and BMI improvement; mostly due to low-calorie diet. It seems that adding a dietitian consultation on the lymphedema management strategy may provide a better result in lymphedema control.",2020,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","['patients with BCRL', 'breast cancer-related lymphedema', '135 overweight and obese women with BCRL aged 18-65 years old', 'breast cancer especially breast cancer-related lymphedema (BCRL', '121 subjects completed the trial']","['synbiotic supplementation', 'CRS', 'Synbiotic supplementation', 'placebo', 'calorie-restricted diet plus 10 9 \xa0CFU synbiotic supplement (CRS group; n\xa0=\xa045) or placebo (CRP', 'calorie restriction', 'Complete Decongestive Therapy']","['BMI', 'quality of life, edema volume, and BMI improvement', 'quality of life and edema volume', 'edema volume', 'quality of life score, edema volume and body mass index (BMI', 'total quality of life score', 'quality of life and edema reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0474212', 'cui_str': 'Reduction of edema'}]",135.0,0.165473,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","[{'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarrati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: zarrati_ms@yahoo.com.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Malakootinejad', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Saneei', 'Initials': 'AS', 'LastName': 'Totmaj', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Zayeri', 'Affiliation': 'Proteomics Research Center and Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Sanati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahpar', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': 'Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran. Electronic address: sha_haghighat@yahoo.com.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.08.008']
2706,32902856,Preventing smoking relapse in patients with cancer: A randomized controlled trial.,"BACKGROUND
Abstaining from smoking after a cancer diagnosis is critical to mitigating the risk of multiple adverse health outcomes. Although many patients with cancer attempt to quit smoking, the majority relapse. The current randomized controlled trial evaluated the efficacy of adapting an evidence-based smoking relapse prevention (SRP) intervention for patients with cancer.
METHODS
The trial enrolled 412 patients newly diagnosed with cancer who had recently quit smoking. Participants were randomized to usual care (UC) or SRP. Participants in the UC group received the institution's standard of care for treating tobacco use. Participants in the SRP group in addition received a targeted educational DVD plus a validated self-help intervention for preventing smoking relapse. The primary outcome was smoking abstinence at 2 months, 6 months, and 12 months.
RESULTS
Abstinence rates for participants in the SRP and UC groups were 75% versus 71% at 2 months and 69% versus 64% at 6 months (Ps > .20). At 12 months, abstinence rates among survivors were 68% for those in the SRP group and 63% for those in the UC group (P = .38). Post hoc analyses revealed that across 2 months and 6 months, patients who were married/partnered were more likely to be abstinent after SRP than UC (P = .03).
CONCLUSIONS
A smoking relapse prevention intervention did not reduce relapse rates overall, but did appear to have benefited those participants who had the social support of a partner. Future work is needed to extend this effect to the larger population of patients.",2020,"RESULTS
Abstinence rates for participants in the SRP and UC groups were 75% versus 71% at 2 months and 69% versus 64% at 6 months (Ps > .20).","['412 patients newly diagnosed with cancer who had recently quit smoking', 'patients with cancer']","['usual care (UC) or SRP', 'targeted educational DVD plus a validated self-help intervention', 'evidence-based smoking relapse prevention (SRP) intervention']","['abstinence rates', 'smoking abstinence', 'Abstinence rates', 'smoking relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",412.0,0.109029,"RESULTS
Abstinence rates for participants in the SRP and UC groups were 75% versus 71% at 2 months and 69% versus 64% at 6 months (Ps > .20).","[{'ForeName': 'Vani N', 'Initials': 'VN', 'LastName': 'Simmons', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Sutton', 'Affiliation': 'Department of Oncologic Sciences, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Meltzer', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Martinez', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Palmer', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Cathy D', 'Initials': 'CD', 'LastName': 'Meade', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Jacobsen', 'Affiliation': 'Healthcare Delivery Research Program, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Judith C', 'Initials': 'JC', 'LastName': 'McCaffrey', 'Affiliation': 'Department of Otolaryngology, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Haura', 'Affiliation': 'Department of Thoracic Oncology, H. Lee Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, Florida.'}]",Cancer,['10.1002/cncr.33162']
2707,32914653,Replication of randomized clinical trial results using real-world data: paving the way for effectiveness decisions.,"The FDA is preparing guidance about using real-world evidence (RWE) to support decisions about product effectiveness. Several ongoing efforts aim to replicate randomized clinical trial (RCT) results using RWE with the intent of identifying circumstances and methods that provide valid evidence of drug effects. Lack of agreement may not be due to faulty methods but rather to the challenges with emulating RCTs, differences in healthcare settings and patient populations, differences in effect measures and data analysis, bias, and/or the efficacy-effectiveness gap. In fact, for some decisions, RWE may lead to better understanding of how treatments work in usual care settings than a more constrained view from RCTs. Efforts to reconcile the role and opportunities for generating complementary evidence from RWE and RCTs will advance regulatory science.",2020,"In fact, for some decisions, RWE may lead to better understanding of how treatments work in usual care settings than a more constrained view from RCTs.",[],[],[],[],[],[],,0.148918,"In fact, for some decisions, RWE may lead to better understanding of how treatments work in usual care settings than a more constrained view from RCTs.","[{'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Sheffield', 'Affiliation': 'Global Patient Outcomes & Real World Evidence, Eli Lilly & Company, Indianapolis, IN 46225, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Dreyer', 'Affiliation': 'IQVIA Real-World & Analytic Solutions, Cambridge, MA 02139, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Murray', 'Affiliation': 'Global Patient Outcomes & Real World Evidence, Eli Lilly & Company, Indianapolis, IN 46225, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Faries', 'Affiliation': 'Real World Analytics, Eli Lilly & Company, Indianapolis, IN 46225, USA.'}, {'ForeName': 'Megan N', 'Initials': 'MN', 'LastName': 'Klopchin', 'Affiliation': 'Global Patient Outcomes & Real World Evidence, Eli Lilly & Company, Indianapolis, IN 46225, USA.'}]",Journal of comparative effectiveness research,['10.2217/cer-2020-0161']
2708,32910717,"IL-2 and IL-2R gene polymorphisms and immune function in people residing in areas with high background radiation, Yangjiang, China.","PURPOSE
Long-term exposure to low dose radiation may trigger immune response and stimulate hormesis. Interleukin-2 ( IL-2 ) and interleukin-2 receptor ( IL-2R ) play a crucial role in immune function. We aimed to explore the possible association of IL-2 and IL-2R gene polymorphisms with low dose radiation exposure, as well as the relationship with IL-2 gene expression in people residing in areas with a high background radiation in Yangjiang, China.
MATERIALS AND METHODS
We recruited and assigned 54 native men residing in Yangxi County, Yangjiang city to the high natural background radiation (HNBR) group, and 53 native men residing in Hengpi County, Enping city to the control area (CA) group. All the participants wore a thermoluminescent dosimeter (TLD) for 90 days, and answered questionnaires. The serum levels of IL2, IL4, IL5, sIL2R, and tumor growth factor (TGF), and expression levels of IL2RA , IL2RB , IL2RG , and IL2 were also analyzed. Additionally, we tested 10 polymorphic loci associated with the IL-2 gene.
RESULTS
The annual effective radiation doses in the HNBR and CA groups were 6.24 mSv y -1 and 1.95 mSv y -1 , respectively. After adjusting for potential confounding factors, the serum levels of IL-2 and IL-5 were higher in the HNBR group than the CA group ( p < .05), while the serum level of TGFβ was lower in the HNBR group ( p < .05). The IL-2 gene mRNA expression level was higher in the HNBR group than the CA group ( p < .05). The IL-2RB rs76206423 AA allele showed significant variations in the HNBR group ( p = .0381).
CONCLUSIONS
Long-term exposure to low dose radiation may enhance immune function, and IL-2RB rs76206423 may be related to the expression of IL-2 by other coding variants. Moreover, our data provide a better understanding of the molecular mechanism of the immune response to low dose radiation.",2020,The IL-2 gene mRNA expression level was higher in the HNBR group than the CA group ( p < 0.05).,"['people residing in areas with a high background radiation in Yangjiang, China', '54 native men residing in Yangxi County, Yangjiang city to the high natural background radiation (HNBR) group, and 53 native men residing in Hengpi County, Enping city to the control area (CA) group', 'people residing in areas with high background radiation, Yangjiang, China']",['Interleukin-2 ( IL-2 ) and interleukin-2 receptor ( IL-2R '],"['IL-2 gene mRNA expression level', 'serum levels of IL-2 and IL-5', 'serum level of TGFβ', 'serum levels of IL2, IL4, IL5, sIL2R, and tumor growth factor (TGF), and expression levels of IL2RA , IL2RB , IL2RG , and IL2']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004607', 'cui_str': 'Background radiation'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0034819', 'cui_str': 'Interleukin-2 receptor'}]","[{'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C1700887', 'cui_str': 'IL2RA protein, human'}, {'cui': 'C1259013', 'cui_str': 'IL2RB protein, human'}, {'cui': 'C1568975', 'cui_str': 'IL2RG protein, human'}]",54.0,0.0344582,The IL-2 gene mRNA expression level was higher in the HNBR group than the CA group ( p < 0.05).,"[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cuiju', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Shibiao', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Ying', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Rongzong', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Haijuan', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Huifeng', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Tianjian', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}]",International journal of radiation biology,['10.1080/09553002.2020.1820607']
2709,32912192,Antibiotic prescribing and non-prescribing in nursing home residents with signs and symptoms ascribed to urinary tract infection (ANNA): study protocol for a cluster randomized controlled trial.,"BACKGROUND
Antibiotic overprescribing for suspected urinary tract infection (UTI) in nursing homes (NHs) is common. Typical clinical scenarios in which antibiotics are inappropriately prescribed include response to nonspecific signs and symptoms and/or a positive urine test in the absence of symptoms referable to the urinary tract. These and other scenarios for inappropriate antibiotic prescribing were addressed in a recent international Delphi study which resulted in the development of a decision tool for the empiric treatment of UTI in frail older adults. The aim of the current study is to implement this decision tool, by integrating it into the electronic health record (EHR) and providing education on its content and use, and to evaluate its effect on appropriate antibiotic prescribing. An additional aim is to evaluate the quality of the intervention and the implementation process.
METHODS
A cluster Randomized Controlled Trial (cRCT) is conducted in sixteen NHs and aims to include 897 residents diagnosed with suspected UTI. NHs in the intervention group use the EHR-integrated decision tool, and receive education for physicians and nursing staff; in the control group care as usual is provided. Data is collected through case report forms within the EHR at the day of diagnosis and at 3, 7, and 21 days thereafter. The primary outcome is appropriate antibiotic prescribing for suspected UTI at the day of diagnosis. Secondary outcomes include the course of symptoms, alternative diagnoses, treatment changes, complications, hospitalization, and mortality. Data on total antibiotic prescribing are additionally collected in the participating NHs 12 months before and during the study. Finally, the process evaluation combines cRCT data with questionnaires and qualitative interviews with NH professionals.
DISCUSSION
This is the first cRCT to evaluate the recently developed, international decision tool for empiric treatment of suspected UTI in NH residents. Study findings will elucidate the effect of the intervention on appropriate antibiotic prescribing for suspected UTI, and provide insight into the applicability of the decision tool in NHs in general and in specific subgroups of NH residents. With this study we aim to contribute to antibiotic stewardship efforts in long-term care.
TRIAL REGISTRATION
The ANNA study was registered at the Netherlands Trial Register on 26 February 2019, with identification number NTR NL7555 .",2020,"This is the first cRCT to evaluate the recently developed, international decision tool for empiric treatment of suspected UTI in NH residents.","['897 residents diagnosed with suspected UTI', '26 February 2019, with identification number NTR NL7555 ', 'frail older adults', 'nursing home residents with signs and symptoms ascribed to urinary tract infection (ANNA']",['Antibiotic prescribing and non-prescribing'],"['total antibiotic prescribing', 'appropriate antibiotic prescribing for suspected UTI at the day of diagnosis', 'course of symptoms, alternative diagnoses, treatment changes, complications, hospitalization, and mortality']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1277624', 'cui_str': 'Suspected UTI (urinary tract infection)'}, {'cui': 'C1300638', 'cui_str': 'Identification number'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1277624', 'cui_str': 'Suspected UTI (urinary tract infection)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2919691', 'cui_str': 'Treatment changed'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0993058,"This is the first cRCT to evaluate the recently developed, international decision tool for empiric treatment of suspected UTI in NH residents.","[{'ForeName': 'Jeanine J S', 'Initials': 'JJS', 'LastName': 'Rutten', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Laura W', 'Initials': 'LW', 'LastName': 'van Buul', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands. L.vanbuul@amsterdamumc.nl.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Smalbrugge', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Geerlings', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases division, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Debby L', 'Initials': 'DL', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Primary and Community care, Radboud Institute for Health Sciences, Radboudumc Alzheimer Center, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Natsch', 'Affiliation': 'Department of Pharmacy, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Sloane', 'Affiliation': 'Department of Family Medicine, School of Medicine, and the Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Ruth B', 'Initials': 'RB', 'LastName': 'Veenhuizen', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Cees M P M', 'Initials': 'CMPM', 'LastName': 'Hertogh', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}]",BMC geriatrics,['10.1186/s12877-020-01662-0']
2710,32878963,"DUETTE: a phase II randomized, multicenter study to investigate the efficacy and tolerability of a second maintenance treatment in patients with platinum-sensitive relapsed epithelial ovarian cancer, who have previously received poly(ADP-ribose) polymerase (PARP) inhibitor maintenance treatment.","BACKGROUND
With the success of poly(ADP-ribose) polymerase (PARP) inhibitor therapy in the first-line and second-line treatment settings, a new patient population is emerging with platinum-sensitive relapsed ovarian cancer, who have previously received a PARP inhibitor in the maintenance setting and for whom no second maintenance standard of care exists. DUETTE (NCT04239014) will evaluate the combination of ceralasertib (a potent, selective inhibitor of the serine/threonine kinase ataxia telangiectasia and Rad3-related protein (ATR) + olaparib, or olaparib monotherapy, compared with placebo, in this patient population of unmet need.
PRIMARY OBJECTIVE
The primary objective is to assess the efficacy of ceralasertib + olaparib combination, and olaparib monotherapy, compared with placebo, as second maintenance therapy in platinum-sensitive relapsed ovarian cancer.
STUDY HYPOTHESIS
This study will test the hypothesis that ceralasertib + olaparib, or olaparib monotherapy, is tolerable, and effective at prolonging progression-free survival compared with placebo.
TRIAL DESIGN
This is a phase II, multicenter study where patients will be randomized in a 1:1:1 ratio to receive either (Arm 1) ceralasertib + olaparib, (Arm 2) olaparib monotherapy, or (Arm 3) placebo. The olaparib and placebo arms will be double-blinded, whereas the ceralasertib + olaparib arm will be open label. Patients will be stratified according to BRCA status, and response to platinum-based chemotherapy.
MAJOR INCLUSION/EXCLUSION CRITERIA
Eligible patients will have histologically diagnosed high-grade epithelial ovarian cancer, with platinum-sensitive relapse on, or after, completion of at least 6 months of any prior PARP inhibitor maintenance therapy (a minimum of 12 months is required if the patient received PARP inhibitor maintenance following first-line chemotherapy). If the prior PARP inhibitor used was olaparib then patients must have received treatment without significant toxicity or the need for a permanent dose reduction. Disease relapse in the second-line or third-line setting is allowed. Patients who have received secondary debulking surgery are potentially eligible if they meet all other inclusion criteria.
PRIMARY ENDPOINTS
The primary endpoint is progression-free survival determined by blinded independent central review according to RECIST 1.1, with sensitivity analysis of progression-free survival using investigator assessments according to RECIST 1.1.
SAMPLE SIZE
192 patients.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS
December 2022.
TRIAL REGISTRATION
NCT04239014.",2020,"The primary endpoint is progression-free survival determined by blinded independent central review according to RECIST 1.1, with sensitivity analysis of progression-free survival using investigator assessments according to RECIST 1.1.
","['platinum-sensitive relapsed ovarian cancer', '192 patients', 'Eligible patients will have histologically diagnosed high-grade epithelial ovarian cancer, with platinum-sensitive relapse on, or after, completion of at least 6 months of any prior', 'Patients who have received secondary debulking surgery are potentially eligible if they meet all other inclusion criteria', 'patients with platinum-sensitive relapsed epithelial ovarian cancer, who have previously received poly(ADP-ribose) polymerase (PARP) inhibitor maintenance treatment', 'December 2022']","['olaparib and placebo', 'PARP inhibitor', 'Rad3-related protein (ATR) + olaparib, or olaparib monotherapy', 'poly(ADP-ribose) polymerase (PARP) inhibitor therapy', 'placebo', 'ceralasertib + olaparib, (Arm 2) olaparib monotherapy, or (Arm 3) placebo', 'PARP inhibitor maintenance therapy', 'ceralasertib + olaparib, or olaparib monotherapy', 'ceralasertib + olaparib combination, and olaparib monotherapy']","['progression-free survival', 'Disease relapse', 'efficacy and tolerability']","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C3711837', 'cui_str': 'ATR protein, human'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.260806,"The primary endpoint is progression-free survival determined by blinded independent central review according to RECIST 1.1, with sensitivity analysis of progression-free survival using investigator assessments according to RECIST 1.1.
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McMullen', 'Affiliation': 'Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Karakasis', 'Affiliation': 'Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Bienvenu', 'Initials': 'B', 'LastName': 'Loembe', 'Affiliation': 'AstraZeneca R&D, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dean', 'Affiliation': 'AstraZeneca R&D, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Graem', 'Initials': 'G', 'LastName': 'Parr', 'Affiliation': 'AstraZeneca R&D, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada amit.oza@uhn.ca.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001694']
2711,32882517,"Improving abnormal gait patterns by using a gait exercise assist robot (GEAR) in chronic stroke subjects: A randomized, controlled, pilot trial.","BACKGROUND
Although the Gait Exercise Assist Robot (GEAR) has been reported to effectively improve gait of hemiplegic patients, no study has investigated its use in chronic stroke patients. It is possible to facilitate gait reorganization by gait training with less compensation using the GEAR even in chronic stroke patients.
RESEARCH QUESTION
What are the effects of GEAR training on the abnormal gait patterns of chronic stroke subjects?
METHODS
Subjects were randomly assigned to either the GEAR group (n = 8) or the treadmill group (n = 11). Each group underwent 20 sessions (40 min/day, 5 days/week). The changes in the 10 types of abnormal gait patterns were evaluated using a three-dimensional motion analysis system and the Global Rating of Change (GRC) scale before and after the intervention, and at 1-month and 3-month follow-up assessment.
RESULTS
In the GEAR group, hip hiking at a 1-month follow-up assessment was markedly lesser than that before the intervention, and the excessive hip external rotation at 3-month follow-up assessment was notably lesser than that after the intervention, but the change in excessive hip external rotation was in the normal range. In the treadmill group, knee extensor thrust at a 1-month follow-up assessment was strikingly lesser than that before the intervention, but the difference was in the normal range. In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention. But, in the treadmill group, only the GRC scale score at a 1-month follow-up assessment was visibly higher than that before the intervention.
SIGNIFICANCE
Gait training using the GEAR may be more effective than treadmill-training in improving the swing phase in chronic stroke subjects.",2020,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","['chronic stroke patients', 'chronic stroke subjects', 'Subjects']","['GEAR', 'Gait Exercise Assist Robot (GEAR', 'GEAR training', 'gait exercise assist robot (GEAR', 'Gait training']","['excessive hip external rotation', 'hip hiking', 'Global Rating of Change (GRC) scale', 'GRC scale score', 'GRC scale scores']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C4255280', 'cui_str': 'Hiking'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0196297,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","[{'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ogino', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan. Electronic address: ogino0327@gmail.com.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kanata', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Uegaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Tatuya', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Katuhisa', 'Initials': 'K', 'LastName': 'Morisaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Domen', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.017']
2712,32886102,Effect of Multilevel Upper Airway Surgery vs Medical Management on the Apnea-Hypopnea Index and Patient-Reported Daytime Sleepiness Among Patients With Moderate or Severe Obstructive Sleep Apnea: The SAMS Randomized Clinical Trial.,"Importance
Many adults with obstructive sleep apnea (OSA) use device treatments inadequately and remain untreated.
Objective
To determine whether combined palatal and tongue surgery to enlarge or stabilize the upper airway is an effective treatment for patients with OSA when conventional device treatment failed.
Design, Setting, and Participants
Multicenter, parallel-group, open-label randomized clinical trial of upper airway surgery vs ongoing medical management. Adults with symptomatic moderate or severe OSA in whom conventional treatments had failed were enrolled between November 2014 and October 2017, with follow-up until August 2018.
Interventions
Multilevel surgery (modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction; n = 51) or ongoing medical management (eg, advice on sleep positioning, weight loss; n = 51).
Main Outcomes and Measures
Primary outcome measures were the apnea-hypopnea index (AHI; ie, the number of apnea and hypopnea events/h; 15-30 indicates moderate and >30 indicates severe OSA) and the Epworth Sleepiness Scale (ESS; range, 0-24; >10 indicates pathological sleepiness). Baseline-adjusted differences between groups at 6 months were assessed. Minimal clinically important differences are 15 events per hour for AHI and 2 units for ESS.
Results
Among 102 participants who were randomized (mean [SD] age, 44.6 [12.8] years; 18 [18%] women), 91 (89%) completed the trial. The mean AHI was 47.9 at baseline and 20.8 at 6 months for the surgery group and 45.3 at baseline and 34.5 at 6 months for the medical management group (mean baseline-adjusted between-group difference at 6 mo, -17.6 events/h [95% CI, -26.8 to -8.4]; P < .001). The mean ESS was 12.4 at baseline and 5.3 at 6 months in the surgery group and 11.1 at baseline and 10.5 at 6 months in the medical management group (mean baseline-adjusted between-group difference at 6 mo, -6.7 [95% CI, -8.2 to -5.2]; P < .001). Two participants (4%) in the surgery group had serious adverse events (1 had a myocardial infarction on postoperative day 5 and 1 was hospitalized for observation following hematemesis of old blood).
Conclusions and Relevance
In this preliminary study of adults with moderate or severe OSA in whom conventional therapy had failed, combined palatal and tongue surgery, compared with medical management, reduced the number of apnea and hypopnea events and patient-reported sleepiness at 6 months. Further research is needed to confirm these findings in additional populations and to understand clinical utility, long-term efficacy, and safety of multilevel upper airway surgery for treatment of patients with OSA.
Trial Registration
Australian New Zealand Clinical Trials Registry: ACTRN12614000338662.",2020,"events/h [95% CI, -26.8 to -8.4]; P < .001).","['102 participants who were randomized (mean [SD] age, 44.6 [12.8] years; 18 [18%] women), 91 (89%) completed the trial', 'Adults with symptomatic moderate or severe OSA in whom conventional treatments had failed were enrolled from August 2014 to November 2017, with follow-up until August 2018', 'Patients With Moderate or Severe Obstructive Sleep Apnea', 'adults with moderate or severe OSA in whom conventional therapy had failed, combined palatal and tongue surgery', 'adults with obstructive sleep apnea (OSA', 'patients with OSA']","['upper airway surgery vs ongoing medical management', 'Multilevel Upper Airway Surgery vs Medical Management', 'combined palatal and tongue surgery', 'Interventions\n\n\nMultilevel surgery (modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction; n\u2009=\u200951) or ongoing medical management (eg, advice on sleep positioning, weight loss; n\u2009=\u200951']","['mean AHI', 'mean ESS', 'Apnea-Hypopnea Index and Patient-Reported Daytime Sleepiness', 'apnea-hypopnea index (AHI; ie, the number of apnea and hypopnea events/h; 15-30 indicates moderate and >30 indicates severe OSA) and the Epworth Sleepiness Scale (ESS; range, 0-24; >10 indicates pathological sleepiness', 'number of apnea and hypopnea events and patient-reported sleepiness', 'serious adverse events']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1535578', 'cui_str': 'Palatopharyngoplasty'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0776524,"events/h [95% CI, -26.8 to -8.4]; P < .001).","[{'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'MacKay', 'Affiliation': 'Illawarra Shoalhaven Local Health District, Wollongong, NSW, Australia.'}, {'ForeName': 'A Simon', 'Initials': 'AS', 'LastName': 'Carney', 'Affiliation': 'Southern ENT & Adelaide Sinus Centre, Flinders Private Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Catcheside', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Ching Li', 'Initials': 'CL', 'LastName': 'Chai-Coetzer', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chia', 'Affiliation': 'Department of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Cistulli', 'Affiliation': 'Charles Perkins Centre, Faculty for Medicine and Health, University of Sydney, NSW, Australia.'}, {'ForeName': 'John-Charles', 'Initials': 'JC', 'LastName': 'Hodge', 'Affiliation': 'Ear Nose and Throat Department, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Illawarra Shoalhaven Local Health District, Wollongong, NSW, Australia.'}, {'ForeName': 'Billingsley', 'Initials': 'B', 'LastName': 'Kaambwa', 'Affiliation': 'Health Economics Unit, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Hollywood Medical Centre, Perth, WA, Australia.'}, {'ForeName': 'Eng H', 'Initials': 'EH', 'LastName': 'Ooi', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Pinczel', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'McArdle', 'Affiliation': 'West Australian Sleep Disorders Research Institute, Queen Elizabeth II Medical Centre, Perth, WA, Australia.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Rees', 'Affiliation': 'The Memorial Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Bhajan', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'West Australian Sleep Disorders Research Institute, Queen Elizabeth II Medical Centre, Perth, WA, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Stow', 'Affiliation': 'The Woolcock Clinic, University of Sydney, NSW, Australia.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Weaver', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, University of Washington, Seattle.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Charmaine M', 'Initials': 'CM', 'LastName': 'Woods', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Aeneas', 'Initials': 'A', 'LastName': 'Yeo', 'Affiliation': 'Department of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}]",JAMA,['10.1001/jama.2020.14265']
2713,32889494,"The closer you feel, the more you care: Positive associations between closeness, pain intensity rating, empathic concern and personal distress to someone in pain.","Previous research revealed inconsistent findings regarding affective responses when facing someone in pain (i.e., empathic concern and/or personal distress). In this paper, we suggest that the degree of closeness between the observer and the person in pain may account for these contradictory results, such that greater closeness towards this person leads to higher personal distress. To test this hypothesis, we induced either low or high closeness with a confederate in 69 randomly assigned participants. Following the closeness induction, participants evaluated their affective responses (empathic concern and personal distress) and rated the confederate's pain intensity after watching the confederate undergoing a painful cold pressure task. Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress. This study thus suggests that closeness is associated with higher cognitive and affective responses to a person in pain.",2020,"Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress.",['69 randomly assigned participants'],['confederate undergoing a painful cold pressure task'],"[""affective responses (empathic concern and personal distress) and rated the confederate's pain intensity"", 'pain intensity rating, empathic concern and personal distress to someone in pain', 'pain intensity rating, empathic concern and personal distress']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",69.0,0.0551593,"Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress.","[{'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Grynberg', 'Affiliation': 'Univ. Lille, CNRS, UMR 9193 - SCALab - Sciences Cognitives et Sciences Affectives, F-59000 Lille, France; Institut Universitaire de France, Paris, France. Electronic address: Delphine.Grynberg@univ-lille.fr.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Konrath', 'Affiliation': 'Lilly Family School of Philanthropy, Indiana University, Indianapolis, IN 46202, United States of America.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103175']
2714,32886795,Locomotor muscle group III/IV afferents constrain stroke volume and contribute to exercise intolerance in human heart failure.,"KEY POINTS
Heart failure patients with reduced ejection fraction (HFrEF) exhibit severe limitations in exercise capacity ( V ̇ O 2 peak). One of the primary peripheral mechanisms suggested to underlie exercise intolerance in HFrEF is excessive locomotor muscle group III/IV afferent feedback; however, this has never been investigated in human heart failure. HFrEF patients and controls performed an incremental exercise test to volitional exhaustion to determine V ̇ O 2 peak with lumbar intrathecal fentanyl or placebo. During exercise, cardiac output, leg blood flow and radial artery and femoral venous blood gases were measured. With fentanyl, compared with placebo, patients with HFrEF achieved a higher peak workload, V ̇ O 2 peak, cardiac output, stroke volume and leg blood flow. These findings suggest that locomotor muscle group III/IV afferent feedback in HFrEF leads to increased systemic vascular resistance, which constrains stroke volume, cardiac output and O 2 delivery thereby impairing V ̇ O 2 peak and thus exercise capacity.
ABSTRACT
To better understand the underlying mechanisms contributing to exercise limitation in heart failure with reduced ejection fraction (HFrEF), we investigated the influence of locomotor muscle group III/IV afferent inhibition via lumbar intrathecal fentanyl on peak exercise capacity ( V ̇ O 2 peak) and the contributory mechanisms. Eleven HFrEF patients and eight healthy matched controls were recruited. The participants performed an incremental exercise test to volitional exhaustion to determine V ̇ O 2 peak with lumbar intrathecal fentanyl or placebo. During exercise, cardiac output and leg blood flow ( Q ̇ L ) were measured via open-circuit acetylene wash-in technique and constant infusion thermodilution, respectively. Radial artery and femoral venous blood gases were measured. V ̇ O 2 peak was 15% greater with fentanyl compared with placebo for HFrEF (P < 0.01), while no different in the controls. During peak exercise with fentanyl, cardiac output was 12% greater in HFrEF secondary to significant decreases in systemic vascular resistance and increases in stroke volume compared with placebo (all, P < 0.01). From placebo to fentanyl, leg V ̇ O 2 , Q ̇ L and O 2 delivery were greater for HFrEF during peak exercise (all, P < 0.01), but not control. These findings indicate that locomotor muscle group III/IV afferent feedback in patients with HFrEF leads to increased systemic vascular resistance, which constrains stroke volume, cardiac output and O 2 delivery, thereby impairing V ̇ O 2 peak and thus exercise capacity. These findings have important clinical implications as V ̇ O 2 peak is highly predictive of morbidity and mortality in HF.",2020,"Results V̇O 2 peak was 15% greater with fentanyl compared to placebo for HFrEF (p<0.01), while not different in the controls.","['Eleven HFrEF patients and 8 healthy matched controls were recruited', 'Heart failure patients with reduced ejection fraction (HFrEF) exhibit severe limitations in exercise capacity (V̇O 2 peak', 'human heart failure', 'heart failure with reduced ejection fraction (HFrEF']","['fentanyl', 'HFrEF', 'incremental exercise test to volitional exhaustion to determine V̇O 2 peak with lumbar intrathecal fentanyl or placebo', 'placebo', 'Locomotor muscle group III/IV afferents constrain stroke volume']","['systemic vascular resistance', 'peak exercise capacity', 'cardiac output and leg blood flow (Q̇', 'Radial artery and femoral venous blood gases', 'cardiac output, leg blood flow, and radial artery and femoral venous blood gases', 'leg V̇O 2 , Q̇ L , and O 2 delivery', 'systemic vascular resistance, which constrains stroke volume, cardiac output, and O 2 delivery thereby impairing V̇O 2 peak and thus exercise capacity', 'stroke volume', 'peak workload, V̇O 2 peak, cardiac output, stroke volume, and leg blood flow']","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}]","[{'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}]",11.0,0.0913429,"Results V̇O 2 peak was 15% greater with fentanyl compared to placebo for HFrEF (p<0.01), while not different in the controls.","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Smith', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, MN, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Joyner', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, MN, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Curry', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, MN, USA.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Borlaug', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, MN, USA.'}, {'ForeName': 'Manda L', 'Initials': 'ML', 'LastName': 'Keller-Ross', 'Affiliation': 'Division of Physical Therapy and Rehabilitation Sciences, University of Minnesota, MN, USA.'}, {'ForeName': 'Erik H', 'Initials': 'EH', 'LastName': 'Van Iterson', 'Affiliation': 'Section of Preventative Cardiology and Rehabilitation, Cleveland Clinic, MN, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Olson', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, MN, USA.'}]",The Journal of physiology,['10.1113/JP280333']
2715,32891738,Efficacy and safety of micafungin in empiric and D-index-guided early antifungal therapy for febrile neutropenia; A subgroup analysis of the CEDMIC trial.,"OBJECTIVES
The D-index is defined as the area over the neutrophil curve during neutropenia. The CEDMIC trial confirmed the noninferiority of D-index-guided early antifungal therapy (DET) using micafungin to empirical antifungal therapy (EAT). In this study, we evaluated the efficacy and safety of micafungin in these settings.
METHODS
From the CEDMIC trial, we extracted 67 and 113 patients who received micafungin in the DET and EAT groups, respectively. Treatment success was defined as the fulfilment of all components of a five-part composite end point. Fever resolution was evaluated at seven days after the completion of therapy.
RESULTS
The proportion of high-risk treatments including induction chemotherapy for acute leukemia and allogeneic hematopoietic stem cell transplantation was significantly higher in the DET group than in the EAT group (82.1% vs. 52.2%). The efficacy of micafungin was 68.7% (95%CI: 56.2-79.4) and 79.6% (71.0-86.6) in the DET and EAT groups, respectively. When we focused on high-risk treatments, the efficacy was 69.1% (55.2-80.9%) and 78.0% (65.3-87.7%), respectively (P = 0.30). There was no significant difference in any of the 5 components between the two groups.
CONCLUSIONS
The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.",2020,The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.,"['febrile neutropenia', 'patients undergoing high-risk treatment', '113 patients who received micafungin in the DET and EAT groups, respectively', 'From the CEDMIC trial']",['micafungin'],"['efficacy and safety', 'Efficacy and safety', 'Fever resolution', 'acute leukemia and allogeneic hematopoietic stem cell transplantation']","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1120386', 'cui_str': 'micafungin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]",,0.054726,The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.,"[{'ForeName': 'Shun-Ichi', 'Initials': 'SI', 'LastName': 'Kimura', 'Affiliation': 'Division of Hematology, Jichi Medical University Saitama Medical Center, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Kanda', 'Affiliation': 'Division of Hematology, Jichi Medical University Saitama Medical Center, Japan; Division of Hematology, Department of Medicine, Jichi Medical University, Japan. Electronic address: ycanda-tky@umin.ac.jp.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Iino', 'Affiliation': 'Department of Medical Oncology, Yamanashi Prefectural Central Hospital, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Japan.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Sakaida', 'Affiliation': 'Department of Hematology, Chiba University Hospital, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Oyake', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Iwate Medical University School of Medicine, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Hematology, Nippon Medical School, Japan.'}, {'ForeName': 'Shin-Ichiro', 'Initials': 'SI', 'LastName': 'Fujiwara', 'Affiliation': 'Division of Hematology, Department of Medicine, Jichi Medical University, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Jo', 'Affiliation': 'Department of Oncology and Hematology / Infection Control Division, Shimane University Hospital, Japan.'}, {'ForeName': 'Akinao', 'Initials': 'A', 'LastName': 'Okamoto', 'Affiliation': 'Department of Hematology, Fujita Health University School of Medicine, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Department of Hematology, Saiseikai Yokohama Nanbu Hospital, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takamatsu', 'Affiliation': 'Division of Medical Oncology, Hematology and Infectious Diseases, Department of Internal Medicine, Fukuoka University Hospital, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Saburi', 'Affiliation': 'Department of Hematology, Oita Prefectural Hospital, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Matsumura', 'Affiliation': 'Department of Hematology and Rheumatology, Kindai University Faculty of Medicine, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yamanouchi', 'Affiliation': 'Departments of Hematology, Clinical Immunology and Infectious Diseases, Ehime University Graduate School of Medicine, Japan.'}, {'ForeName': 'Souichi', 'Initials': 'S', 'LastName': 'Shiratori', 'Affiliation': 'Department of Hematology, Hokkaido University, Faculty of Medicine, Japan.'}, {'ForeName': 'Moritaka', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Hematology, Tokyo Medical University, Japan.'}, {'ForeName': 'Shingen', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Community Medicine and Medical Science, Tokushima University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'General Medical Research Center, Fukuoka University, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.081']
2716,32891871,No tDCS augmented working memory training benefit in undergraduates rewarded with course credit.,"BACKGROUND
The goal of working memory (WM) training is to expand capacity of this executive function. Transcranial direct current stimulation (tDCS) paired with WM training is more consistent than either alone. We have reported that tDCS targeting frontal and/or parietal regions enhanced theta phase locking, reduced alpha power, and strengthened theta-gamma phase amplitude coupling.
OBJECTIVE
To determine whether tDCS to frontal or parietal sites optimized WM training gains we pre-registered a tDCS-WM training study.
METHODS
80 undergraduates were randomly assigned to one of four anodal tDCS montages: frontal (F4), parietal (P4), alternating (P4-F4), and sham (P4 or F4). Participants completed 5-training sessions over one week and returned for follow-up testing after 30 days of no-contact.
RESULTS
No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
CONCLUSIONS
This null finding marks a failure to replicate in undergraduates training benefits observed in graduate students. We argue that motivation is essential to elicit improved performance in training protocols.",2020,"No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
","['graduate students', '80 undergraduates']","['anodal tDCS montages: frontal (F4), parietal (P4), alternating (P4-F4), and sham (P4 or F4', 'Transcranial direct current stimulation (tDCS) paired with WM training', 'working memory (WM) training']",['trained or transfer task performance'],"[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",80.0,0.033538,"No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
","[{'ForeName': 'Jorja', 'Initials': 'J', 'LastName': 'Shires', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Carrasco', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA; University of California, Davis, Program in Neuroscience, Davis, CA, 95616, USA.'}, {'ForeName': 'Marian E', 'Initials': 'ME', 'LastName': 'Berryhill', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA. Electronic address: mberryhill@unr.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.08.015']
2717,32890302,Physical Performance Tests Provide Distinct Information in Both Predicting and Assessing Patient-Reported Outcomes Following Lumbar Spine Surgery.,"STUDY DESIGN
Secondary analysis of randomized controlled trial data.
OBJECTIVE
The aim of this study was to examine whether preoperative physical performance is an independent predictor of patient-reported disability and pain at 12 months after lumbar spine surgery.
SUMMARY OF BACKGROUND DATA
Patient-reported outcome measures (PROMs) are commonly used to assess clinical improvement after lumbar spine surgery. However, there is evidence in the orthopedic literature to suggest that PROMs should be supplemented with physical performance tests to accurately evaluate long-term outcomes.
METHODS
A total of 248 patients undergoing surgery for degenerative lumbar spine conditions were recruited from two institutions. Physical performance tests (5-Chair Stand and Timed Up and Go) and PROMs of disability (Oswestry Disability Index: ODI) and back and leg pain (Brief Pain Inventory) were assessed preoperatively and at 12 months after surgery.
RESULTS
Physical performance tests and PROMs significantly improved over 12 months following lumbar spine surgery (P < 0.01). Weak correlations were found between physical performance tests and disability and pain (ρ = 0.15 to 0.32, P < 0.05). Multivariable regression analyses controlling for age, education, preoperative outcome score, fusion, previous spine surgery, depressive symptoms, and randomization group found that preoperative 5-Chair Stand test was significantly associated with disability and back pain at 12-month follow-up. Each additional 10 seconds needed to complete the 5-Chair Stand test were associated with six-point increase in ODI (P = 0.047) and one-point increase in back pain (P = 0.028) scores. The physical performance tests identified an additional 14% to 19% of patients as achieving clinical improvement that were not captured by disability or pain questionnaires.
CONCLUSION
Results indicate that physical performance tests may provide distinct information in both predicting and assessing clinical outcomes in patients undergoing lumbar spine surgery. Our findings suggest that the 5-Chair Stand test may be a useful test to include within a comprehensive risk assessment before surgery and as an outcome measure at long-term follow-up.
LEVEL OF EVIDENCE
3.",2020,"RESULTS
Physical performance tests and PROMs significantly improved over 12-months following lumbar spine surgery (p < 0.01).","['patients undergoing lumbar spine surgery', 'Lumbar Spine Surgery', '248 patients undergoing surgery for degenerative lumbar spine conditions were recruited from two institutions']",['MINI'],"['disability or pain questionnaires', 'ODI', 'back pain', 'physical performance tests and disability and pain', 'Physical performance tests (5-Chair Stand and Timed Up and Go) and PROMs of disability (Oswestry Disability Index: ODI) and back and leg pain (Brief Pain Inventory', 'disability and back pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0408578', 'cui_str': 'Operation on lumbar spine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",248.0,0.113667,"RESULTS
Physical performance tests and PROMs significantly improved over 12-months following lumbar spine surgery (p < 0.01).","[{'ForeName': 'Hiral', 'Initials': 'H', 'LastName': 'Master', 'Affiliation': 'Department of Orthopedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Jacquelyn S', 'Initials': 'JS', 'LastName': 'Pennings', 'Affiliation': 'Department of Orthopedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Rogelio A', 'Initials': 'RA', 'LastName': 'Coronado', 'Affiliation': 'Department of Orthopedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Abigail L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Department of Orthopedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Orthopedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Haug', 'Affiliation': 'Department of Orthopedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Skolasky', 'Affiliation': 'Department of Orthopedic Surgery, Johns Hopkins Medicine, Baltimore, MD.'}, {'ForeName': 'Lee H', 'Initials': 'LH', 'LastName': 'Riley', 'Affiliation': 'Department of Orthopedic Surgery, Johns Hopkins Medicine, Baltimore, MD.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Neuman', 'Affiliation': 'Department of Orthopedic Surgery, Johns Hopkins Medicine, Baltimore, MD.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurological Surgery, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Oran S', 'Initials': 'OS', 'LastName': 'Aaronson', 'Affiliation': 'Howell Allen Clinic, Saint Thomas Medical Partners, Nashville, TN.'}, {'ForeName': 'Clinton J', 'Initials': 'CJ', 'LastName': 'Devin', 'Affiliation': 'Department of Orthopedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Wegener', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins Medicine, Baltimore, MD.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Archer', 'Affiliation': 'Department of Orthopedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}]",Spine,['10.1097/BRS.0000000000003665']
2718,32896644,Transcranial direct current stimulation: A novel approach in the treatment of vascular depression.,"BACKGROUND
Despite the impact of depression in terms of personal suffering and socioeconomic burden, most currently available treatment options are often ineffective. A particularly difficult-to-treat depressive disorder characteristic of the elderly is vascular depression, a late-life depressive syndrome related to a variety of potential vascular mechanisms. Transcranial Direct Current Stimulation (tDCS), a non-invasive and effective somatic approach to depression, also showed positive effects on cognitive deficits.
AIM
We performed a double-blind randomized study to investigate the efficacy of tDCS as augmentation strategy to sertraline in the treatment of vascular depression, hypothesizing a positive effect in both depressive symptoms and cognitive functions.
METHODS
We enrolled 93 inpatients over 60 years of age with a diagnosis of vascular depression. Depressive symptoms were weekly assessed (T0, T1, T2) with the 21-items Hamilton depression rating scale (HDRS). Cognitive functioning was evaluated with the Milan Overall Dementia Assessment (MODA) at baseline and after the treatment protocol. All patients were randomly assigned into three groups, Group I: one tDCS stimulation per day, Group II: two tDCS stimulations per day, Sham group: one sham tDCS stimulation per day. Stimulation was performed for 10 consecutive working days.
RESULTS
A significant interaction time∗treatment was observed on HDRS scores (F = 14, p < 0.001). All groups improved at T1 but whereas Group II significantly differed from the Sham group (p < 0.001) we observed no difference between Sham and Group I. At T2 all groups improved but Group II showed the greater improvement (vs. Sham p < 0.001; vs. Group I p < 0.001) and the Sham group the smallest (vs. Group I p = 0.005). A significant interaction time∗treatment was also observed on MODA scores (F = 3.31, p = 0.04). Only subjects treated with tDCS improved at T2 (Group I: p < 0.001; Group II: p = 0.007). However, no difference between Group I and II was shown.
CONCLUSION
tDCS as augmentation treatment of an adequate pharmacotherapy is a potential strategy in the management of vascular depression, a disease known to be often unresponsive to antidepressants only. Non-invasiveness, the absence of severe side effects and the possibility of administering it to outpatients at an affordable price make tDCS an important tool in clinical practice.",2020,At T2 all groups improved but Group II showed the greater improvement (vs. Sham p<0.001;,['93 inpatients over 60 years of age with a diagnosis of vascular depression'],"['sertraline', 'tDCS stimulation per day, Group II: two tDCS stimulations per day, Sham group: one sham tDCS stimulation per day', 'Transcranial Direct Current Stimulation (tDCS', 'Transcranial direct current stimulation', 'tDCS']","['MODA scores', 'Depressive symptoms', '21-items Hamilton depression rating scale (HDRS', 'HDRS scores']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",93.0,0.13066,At T2 all groups improved but Group II showed the greater improvement (vs. Sham p<0.001;,"[{'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Zanardi', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy. Electronic address: zanardi.raffaella@hsr.it.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Poletti', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Prestifilippo', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Attanasio', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Barbini', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Colombo', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}]",Brain stimulation,['10.1016/j.brs.2020.08.013']
2719,32681911,Effects of Induced Astigmatism on Spectral Domain-OCT Angiography Quantitative Metrics.,"PURPOSE
To analyze the effect of induced astigmatism on en-face spectral-domain optical coherence tomography angiography quantitative metrics.
DESIGN
Prospective crossover study.
METHODS
Normal eyes without astigmatism and with 0.75, 1.75, and 2.75 diopters (D) of with-the-rule (WTR) astigmatism were imaged using a 3 × 3-mm scan pattern SD-OCTA CIRRUS 5000 HD-OCT with AngioPlex (Carl Zeiss Meditec, Dublin, CA, USA). Quantitative parameters, including foveal avascular zone metrics, parafoveal vessel length density (VD), and perfusion density (PD) were corrected for magnification secondary to axial length and analyzed. Univariate linear regressions were performed within each eye to correlate quantitative metrics to the level of an induced astigmatic cylinder.
RESULTS
Fifteen eyes from 15 patients were imaged. Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001). For every 1-D increase in induced astigmatism, the resulting decrease in the inner ring superior quadrant was 12% greater for VD and 16% greater for PD versus that in the inferior quadrant. The resulting decrease in the inner ring nasal quadrant was 40% greater for VD and 48% greater for PD versus that in the temporal quadrant.
CONCLUSIONS
Increasing levels of induced WTR astigmatism correlated with globally diminishing VD and PD, was more symmetrical for vertical than horizontal quadrants, and was most pronounced nasally. This may be due to a high prevalence of horizontally oriented vessels nasally and the horizontal optical defocus induced by WTR astigmatism.",2020,"Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001).","['Fifteen eyes from 15 patients were imaged', 'Normal eyes without astigmatism and with 0.75, 1.75, and 2.75 diopters (D) of with-the-rule (WTR) astigmatism were imaged using a']","['Induced Astigmatism', '3\xa0× 3-mm scan pattern SD-OCTA CIRRUS 5000 HD-OCT with AngioPlex (Carl Zeiss Meditec, Dublin, CA, USA']","['VD and PD', 'foveal avascular zone metrics, parafoveal vessel length density (VD), and perfusion density (PD', 'inner ring nasal quadrant', 'Spectral Domain-OCT Angiography Quantitative Metrics', 'induced WTR astigmatism']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C4517639', 'cui_str': '2.75'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0454777', 'cui_str': 'Dublin'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1275950', 'cui_str': 'Foveal avascular zone'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0442137', 'cui_str': 'Parafoveal'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1719796', 'cui_str': 'With-the-rule astigmatism'}]",15.0,0.026434,"Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001).","[{'ForeName': 'Jesse J', 'Initials': 'JJ', 'LastName': 'Jung', 'Affiliation': 'East Bay Retina Consultants, Inc., Oakland, California, USA; Department of Ophthalmology, Universtiy of California, San Francisco, San Francisco, California, USA. Electronic address: jung.jesse@gmail.com.'}, {'ForeName': 'Yu Qiang', 'Initials': 'YQ', 'LastName': 'Soh', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sha', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA; Silicon Valley Eyecare Optometry, Santa Clara, California, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Durbin', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA.'}, {'ForeName': 'Quan V', 'Initials': 'QV', 'LastName': 'Hoang', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, Singapore, Singapore; Department of Ophthalmology, Edward S. Harkness Eye Institute, Columbia College of Physicians and Surgeons, New York, New York, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.07.005']
2720,32911242,The effectiveness of a preoperative multi-component non-pharmacologic preparation on post-tonsillectomy pain: A randomized controlled clinical trial.,"INTRODUCTION
Tonsillectomy is a painful operation and some studies have suggested that preoperative non-pharmacologic preparations may decrease postoperative pain. In this randomized clinical trial study, we decided to determine which is more effective in the post-tonsillectomy pain; an informative booklet or a costly, time consuming, sophisticated, and multi-component preparation program.
MATERIALS AND METHODS
Patients were randomly assigned into two groups. In the booklet group, children and their parents only received an informative booklet as routine information preparation. On the other hand, in the multi-component group; in addition to receiving the same booklet, children and their parents received our multi-component pre-operative preparation program. The following items were included in the package: preoperative tour in the ward, an educational DVD, and therapeutic play intervention. All patients were observed at least for 8 h as a day case or ambulatory tonsillectomy. The pain score was recorded according to the visual analog scale for seven days. Finally, the post-tonsillectomy pain scores were compared in the two groups. The multi-component group included 121 children and booklet group 120.
RESULTS
Minimum and maximum age was 9 and 12 years. Regarding post-tonsillectomy pain, we found no significant difference between the multi-component group and the booklet group.
CONCLUSION
Our data revealed that a new concept which is more cost-effective and concise booklet is as effective as costly and sophisticated methods in post-tonsillectomy pain among 9-12 years old children.",2020,"Regarding post-tonsillectomy pain, we found no significant difference between the multi-component group and the booklet group.
","['post-tonsillectomy pain', '121 children and booklet group 120', '9-12 years old children', 'Patients']",['preoperative multi-component non-pharmacologic preparation'],"['pain score', 'tonsillectomy pain scores', 'postoperative pain']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",121.0,0.0305591,"Regarding post-tonsillectomy pain, we found no significant difference between the multi-component group and the booklet group.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: faramarzi@sums.ac.ir.'}, {'ForeName': 'Sareh', 'Initials': 'S', 'LastName': 'Roosta', 'Affiliation': 'Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: Roosta.Sareh@gmail.com.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Faramarzi', 'Affiliation': 'Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: ali_faramarzi@sums.ac.ir.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Salehi', 'Affiliation': 'Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: salehiar@sums.ac.ir.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Matani', 'Affiliation': 'Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: inasmeh@yahoo.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110359']
2721,32911319,"A randomized pilot study assessing the acceptability of rapid point-of-care hepatitis C virus (HCV) testing among male inmates in Montreal, Canada.","BACKGROUND
The Oraquick Ⓡ fingerprick point-of-care hepatitis C virus antibody (HCV-Ab) test is favoured to venipuncture among people who inject drugs; however, its acceptability in prison populations is unknown. We aimed to compare the acceptability of the Oraquick Ⓡ versus standard venipuncture among people in prison.
METHODS
From October to December 2019, 280 sentenced male inmates at L'Établissement de Détention de Montréal (Quebec, Canada) were screened for participation, 150 excluded due to prior HCV screening, and 52 refused participation. The remaining 78 were randomized 1:1 to opt-out HCV-Ab screening with OraQuick Ⓡ or venipuncture (n = 39 each). Acceptability was determined by the proportion accepting to undergo screening.
RESULTS
The majority of participants (median age 33 years) reported a history of drug use (76%; 8% injection drug use); 47% perceived their HCV risk to be moderate/high. All inmates randomized to Oraquick Ⓡ accepted testing while 87% accepted venipuncture. Among those who accepted Oraquick Ⓡ vs. venipuncture, 100% vs. 97% were satisfied with the test, 97% vs. 94% would recommend the same test, and 100% vs. 76% would choose the same test again.
CONCLUSION
Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ compared to venipuncture, and to choose Oraquick Ⓡ for future HCV screening.",2020,"CONCLUSION
Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ compared to venipuncture, and to choose Oraquick Ⓡ for future HCV screening.","[""From October to December 2019, 280 sentenced male inmates at L'Établissement de Détention de Montréal (Quebec, Canada) were screened for participation, 150 excluded due to prior HCV screening, and 52 refused participation"", 'people in prison', 'male inmates in Montreal, Canada', 'Adult incarcerated men in Canada']","['rapid point-of-care hepatitis C virus (HCV', 'venipuncture', 'Ⓡ or venipuncture', 'HCV-Ab screening with OraQuick', 'Oraquick Ⓡ versus standard venipuncture']",['Acceptability'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",280.0,0.0431789,"CONCLUSION
Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ compared to venipuncture, and to choose Oraquick Ⓡ for future HCV screening.","[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Kronfli', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada. Electronic address: nadine.kronfli@mcgill.ca.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Dussault', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chalifoux', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Hasmig', 'Initials': 'H', 'LastName': 'Kavoukian', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Marina B', 'Initials': 'MB', 'LastName': 'Klein', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada; CIHR Canadian HIV Trials Network, Vancouver, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102921']
2722,32917148,"Correction to: Effectiveness of lidocaine/prilocaine cream on cardiovascular reactions from endotracheal intubation and cough events during recovery period of older patients under general anesthesia: prospective, randomized placebo-controlled study.",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['older patients under general anesthesia'],"['placebo', 'lidocaine/prilocaine cream']",['cardiovascular reactions from endotracheal intubation and cough events'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0617623', 'cui_str': 'Lidocaine- and prilocaine-containing product'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0453201,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Linsheng', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'Operation Room, the third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Shanghai Shyndec Pharmaceutical Co., Ltd, Shanghai, 600420, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Division of Nephrology, the third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China. naturestyle@163.com.'}, {'ForeName': 'Miaoxia', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Nursing Department, the third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China. 1109986151@qq.com.'}]",BMC geriatrics,['10.1186/s12877-020-01651-3']
2723,32889172,Validation of local p16 testing for determination of human papilloma virus status eligibility on a low risk oropharyngeal cancer trial - A Trans-Tasman Radiation Oncology Group study.,"OBJECTIVE
Accurate determination of human papilloma virus (HPV) status is critical when identifying patients with oropharyngeal squamous cell carcinoma (OPSCC) who may be candidates for de-escalation trials. In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
METHODS AND MATERIALS
Patients enrolled on the TROG 12.01 randomised trial for good prognosis HPVOPSCC were randomised based on local p16 IHC testing but subsequently had central p16 IHC and HPV RNA in situ hybridisation (HPV RNA ISH) testing. Correlations between the local and central p16 and central HPV RNA ISH were studied. The main outcome was the positive predictive value (PPV) of local pathology laboratory testing of p16.
RESULTS
176/182 patients had samples available for central testing. 172/176 were evaluable for central testing of p16, and all were confirmed to be p16 positive (172/172, 100%, 95% CI = [97.9%, 100%]). Similarly, 100% of those evaluable for HPV RNA ISH (155/155, 100%, 95% CI = [97.6%, 100%]) were confirmed HPV positive, indicating p16 overexpression driven by transcriptionally active HPV and a PPV of 100% for local p16 testing.
CONCLUSIONS
Our results validate the suitability of local pathology laboratory p16 testing alone, in populations with a high attributable fraction of OPSCC due to HPV, to screen and enrol low risk HPVOPSCC patients onto de-intensification trials. This obviates the need for upfront more complex and expensive HPV assays and/or central laboratory testing.",2020,"In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
","['populations with a high attributable fraction of OPSCC due to HPV, to screen and enrol low risk HPVOPSCC patients onto de-intensification trials', 'patients with oropharyngeal squamous cell carcinoma (OPSCC', 'Patients enrolled on the TROG 12.01 randomised trial for good prognosis HPVOPSCC', '176/182 patients had samples available for central testing']",['local p16 IHC testing but subsequently had central p16 IHC and HPV RNA in situ hybridisation (HPV RNA ISH) testing'],"['positive predictive value (PPV) of local pathology laboratory testing of p16', 'local and central p16 and central HPV RNA ISH', 'HPV RNA ISH']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0280313', 'cui_str': 'Squamous cell carcinoma of oropharynx'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0020202', 'cui_str': 'Hybridization'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",,0.269323,"In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Young', 'Affiliation': 'Research Division, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Solomon', 'Affiliation': 'Research Division, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Corry', 'Affiliation': ""Genesiscare St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Angel', 'Affiliation': 'Department of Pathology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Kenny', 'Affiliation': ""Department of Radiation Oncology, Royal Brisbane & Women's Hospital, Brisbane, Australia; Faculty of Medicine, University of Queensland Brisbane, Australia.""}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Porceddu', 'Affiliation': 'Faculty of Medicine, University of Queensland Brisbane, Australia; Department of Radiation Oncology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wratten', 'Affiliation': 'Department of Radiation Oncology, Calvary Mater Hospital and University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Macann', 'Affiliation': 'Department of Radiation Oncology, Auckland City Hospital and University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Jackson', 'Affiliation': 'Radiation Oncology Centres, Gold Coast, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Herschtal', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Rischin', 'Affiliation': 'Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia. Electronic address: danny.rischin@petermac.org.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104988']
2724,32890969,Effect of high-intensity interval training on cardiac structure and function in rats with acute myocardial infarct.,"BACKGROUND
Exercise training is beneficial for cardiac rehabilitation. Nevertheless, few study focused on the role of high-intensity interval training (HIIT) in cardiac repair. The current study aimed to elucidate the effect of HIIT on cardiac rehabilitation and the involved mechanisms after acute myocardial infarction (MI).
METHODS
A total of 65 male rats underwent coronary ligation or sham operation and were randomly assigned to 4 groups: sham (n = 10), sedentary (MI-Sed, n = 12), moderate-intensity continuous training (MI-MCT, n = 12) and HIIT (MI-HIIT, n = 12). One week after MI induction, adaptive training starts follow by formal training. After the experiment, cardiac functions were determined by echocardiography and hemodynamic measurements. Changes in infarct size, collagen accumulation, myofibroblasts, angiogenesis, inflammation level, endothelin-1 (ET-1), and renin-angiotensin-aldosterone system (RAAS) activities were measured. Data were analyzed by one-way ANOVA.
RESULTS
After MI, cardiac structure and function were significantly deteriorated. However, post-MI HIIT for 8 weeks had significantly ameliorated left ventricular end-diastolic pressure (LVEDP), LV systolic pressure (LVSP), and maximum peak velocities of relaxation (-dP/dtmax). Moreover, it preserved cardiac functions, reduced infarct size, protected the myocardium structure, increased angiogenesis and decreased the myofibroblasts and collagen accumulation. HIIT for 4 weeks had no effect on LVEDP, -dP/dtmax, infarct size and angiogenesis. Additionally, it induced inflammation response and repressed ET-1 and RAAS activities were found in myocardium and peripheral circulation after HIIT.
CONCLUSION
Our results suggested that post-MI HIIT had a positive role in cardiac repair, which might be linked with the induction of inflammation and inhibition of ET-1 and RAAS activities.",2020,"HIIT for 4 weeks had no effect on LVEDP, -dP/dtmax, infarct size and angiogenesis.","['65 male rats underwent', 'rats with acute myocardial infarct']","['Exercise training', 'HIIT', 'coronary ligation or sham operation', 'high-intensity interval training', 'moderate-intensity continuous training']","['RAAS) activities', 'cardiac functions', 'inflammation response and repressed ET-1 and RAAS activities', 'cardiac structure and function', 'myofibroblasts and collagen accumulation', 'LVEDP, -dP/dtmax, infarct size and angiogenesis', 'ameliorated left ventricular end-diastolic pressure (LVEDP), LV systolic pressure (LVSP), and maximum peak velocities of relaxation (-dP/dtmax', 'infarct size, collagen accumulation, myofibroblasts, angiogenesis, inflammation level, endothelin-1 (ET-1), and renin-angiotensin-aldosterone system ']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0225360', 'cui_str': 'Myofibroblast'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",65.0,0.0338951,"HIIT for 4 weeks had no effect on LVEDP, -dP/dtmax, infarct size and angiogenesis.","[{'ForeName': 'Bozhong', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Rongfang', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Xinwen', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Shou', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Cuicui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Tong', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Genxiang', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': 'Zhejiang Provincial Key Laboratory of Geriatrics & Geriatrics Institute of Zhejiang Province, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Zhejiang Provincial Key Laboratory of Geriatrics & Geriatrics Institute of Zhejiang Province, Hangzhou, 310013, Zhejiang, China. Electronic address: aaiwuqing@126.com.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.110690']
2725,32891018,Effects of multimodal balance training supported by rhythmical auditory stimuli in people with advanced stages of Parkinson's disease: a pilot randomized clinical trial.,"Non-pharmacological interventions such as physiotherapy are recognized as important elements in the overall clinical management of motor impairments in PD, but evidence of physiotherapy in advanced disease stages is sparse. A recent trial found positive effects of multimodal balance training in people with mild to moderate PD, with greater and more sustained effects when rhythmical auditory stimuli were added. It is unclear whether such multimodal balance training is also effective in people with advanced PD (Hoehn & Yahr stage 4).
METHODS
We performed a pilot prospective single-blind, randomized clinical trial to study the effectiveness of multimodal training with and without rhythmical auditory stimuli. We screened 76 people with Parkinson's disease and Hoehn & Yahr stage 4 by telephone; 35 patients were assigned randomly into two groups: (1) multimodal balance training with rhythmical auditory stimuli (RAS-supported intervention, n = 17) and (2) multimodal balance training without rhythmical auditory cues (n = 18). Training was performed for 5 weeks, two times/week. Primary outcome was the Mini-BESTest (MBEST) score immediately after the training period. Assessments were performed by the same two blinded assessors at baseline, immediately post intervention, and after one and 6-months follow-up.
RESULTS
Immediately post-intervention, both intervention groups improved significantly on Mini-Best scores, without differences between both intervention modalities. In both groups, results were retained at one-month follow-up. At 6-months follow-up, the effects were retained only in the RAS-supported intervention group. For both intervention groups, no improvements were found on secondary outcome measures for gait.
CONCLUSION
Both RAS-supported multimodal balance training and regular multimodal balance training improve balance in PD patients in advanced disease stages. Effects appear to sustain longer in the RAS-supported training group.",2020,"For both intervention groups, no improvements were found on secondary outcome measures for gait.
","['PD patients in advanced disease stages', ""people with advanced stages of Parkinson's disease"", 'people with advanced PD (Hoehn & Yahr stage 4', 'people with mild to moderate PD', ""76 people with Parkinson's disease and Hoehn & Yahr stage 4 by telephone; 35 patients""]","['multimodal balance training with rhythmical auditory stimuli (RAS-supported intervention, n\xa0=\xa017) and (2) multimodal balance training without rhythmical auditory cues', 'multimodal balance training and regular multimodal balance training', 'multimodal balance training', 'multimodal training with and without rhythmical auditory stimuli']","['Mini-BESTest (MBEST) score', 'gait', 'Mini-Best scores', 'rhythmical auditory stimuli']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}]",76.0,0.0570846,"For both intervention groups, no improvements were found on secondary outcome measures for gait.
","[{'ForeName': 'Tamine T C', 'Initials': 'TTC', 'LastName': 'Capato', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands; University of São Paulo, Department of Neurology, Movement Disorders Center, São Paulo, Brazil. Electronic address: tamine.capato@radboudumc.nl.'}, {'ForeName': 'Jorik', 'Initials': 'J', 'LastName': 'Nonnekes', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour; Department of Rehabilitation, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands; Sint Maartenskliniek, Department of Rehabilitation, Nijmegen, the Netherlands.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Radboud University Medical Center, Department for Health Evidence, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'University of São Paulo, Department of Neurology, Movement Disorders Center, São Paulo, Brazil.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117086']
2726,32896089,Effect of behavioral intervention on medication adherence among elderly with select non-communicable diseases (ENDORSE): Pilot randomized controlled trial.,"AIM
Adherence to medication is important in older patients with non-communicable diseases, and there is a need to investigate various interventions to enhance adherence in our Indian setting. This pilot randomized controlled trial aimed at testing the effectiveness of systematic education and behavioral intervention in enhancing medication adherence among older adults.
METHODS
It was a single center, open label, parallel arm, randomized controlled trial carried out among older (age >60 years) inpatients of general medicine wards diagnosed with select non-communicable diseases, such as diabetes, hypertension, dyslipidemia and coronary artery disease. Participants were randomized either to receive the usual standard of care or the intervention that comprises of systematic education, patient diary to mark daily medicine intake and periodic telephone reminders. Barriers to medication adherence were identified and interventions were tailored according to the identified barriers over a 6-month follow-up period. The primary end-points were change in the reported pill count (RPC) within groups and between groups at the third and sixth month.
RESULTS
The RPC in control and intervention arms at the thrid month were 78.20% and 91.88% (P = 0.007), whereas at 6 months they were 68.64% and 83.08% (P = 0.003), respectively. Similarly, change in RPC in intervention arm between baseline and the third month (mean difference 24.08%, P = 0.001), and between baseline and the sixth month (mean difference 15.280%, P = 0.006) were statistically significant. However, the RPC between the third and sixth month showed a significant decline (mean difference 8.8%, P = 0.016).
CONCLUSION
In this pilot study, we prove that behavioral interventions have improved medication adherence among older adults, and it is feasible to carry out such studies among older adults in India. Geriatr Gerontol Int 2020; 20: 1079-1084.",2020,Barriers to medication adherence were identified and interventions were tailored according to the identified barriers over a 6-month follow-up period.,"['older adults', 'elderly with select non-communicable diseases (ENDORSE', 'older patients with non-communicable diseases', 'older adults in India', 'older (age >60\u2009years) inpatients of general medicine wards diagnosed with select non-communicable diseases, such as diabetes, hypertension, dyslipidemia and coronary artery disease']","['behavioral interventions', 'usual standard of care or the intervention that comprises of systematic education, patient diary to mark daily medicine intake and periodic telephone reminders', 'systematic education and behavioral intervention', 'behavioral intervention']","['change in RPC', 'pill count (RPC', 'medication adherence']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",,0.0561124,Barriers to medication adherence were identified and interventions were tailored according to the identified barriers over a 6-month follow-up period.,"[{'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Raj', 'Affiliation': ""Department of Pharmacology, St. John's Medical College, Bengaluru, India.""}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Mathews', 'Affiliation': ""Division of Geriatrics, Department of Medicine, St. John's Medical College, Bengaluru, India.""}]",Geriatrics & gerontology international,['10.1111/ggi.14032']
2727,32896184,"Remdesivir, a remedy or a ripple in severe COVID-19?","INTRODUCTION
In clinical trial for the Ebola virus, the broad-spectrum anti-viral agent remdesivir was shown to have a good safety profile. Remdesivir is now being tested in severe COVID-19.
AREAS COVERED
The Gilead Sciences SIMPLE trial suggests that the short-term use of remdesivir probably does not increase mortality dramatically or have serious short-term toxicity when used to treat severe COVID-19. The Adaptive COVID-19 treatment trials (ACTT1) trial showed that remdesivir may shorten recovery and decrease mortality in severe COVID-19 without increasing adverse effects.
EXPERT OPINION
It seems to me that we have learnt very little from the SIMPLE trial, and this would be predicted from a trial that has no control or placebo group. The results of ACTT1 were reported early after an interim analysis showed that a higher than expected number of recoveries had occurred. There was an indication that remdesivir may be reducing mortality, but this was no statistical significance. The trial is continuing, and the final data are eagerly awaited to determine whether remdesivir is a game-changing remedy or a ripple in the ongoing search for a medicine for the treatment of COVID-19.",2020,"There was an indication that remdesivir may be reducing mortality, but this was not statistical significance.",[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.155191,"There was an indication that remdesivir may be reducing mortality, but this was not statistical significance.","[{'ForeName': 'Sheila A', 'Initials': 'SA', 'LastName': 'Doggrell', 'Affiliation': 'Faculty of Health, Queensland University of Technology , Brisbane, Australia.'}]",Expert opinion on investigational drugs,['10.1080/13543784.2020.1821645']
2728,32898517,Cardiac autonomic and blood pressure responses to an acute session of battling ropes exercise.,"BACKGROUND
Battling rope (BTR) exercise has become incredibly popular among not only fitness enthusiasts and athletes but in the general exercising population. Despite its popularity, research regarding the acute cardiovascular responses to BTR exercise is limited. This investigation evaluated the effects of acute BTR exercise on heart rate variability (HRV) and blood pressure (BP) responses in young men with elevated BP.
MATERIALS AND METHODS
Eleven young men with elevated BP completed either a BTR or a non-exercise control trial in randomized order. The BTR trial consisted of 10 rounds of BTR exercise. Each round included 30 s of exercise followed by 30 s of rest. HRV and BP were evaluated at baseline and 3, 10, and 30 min following each trial.
RESULTS
There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 min following the BTR trial, whereas no changes from baseline were detected after control. Additionally, there were significant reductions (p ˂0.01) in markers of vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations) for 30 min; as well as (p ˂0.01) systolic BP and diastolic BP at 10 and 30 min after the BTR, but not the control trial.
CONCLUSION
Current findings revealed that BTR exercise elevates sympathovagal balance for 30 min post-intervention, which is concurrent with an impressive hypotensive effect. Further investigations are warranted to assess the potential clinical application of BTR exercise not only in cohorts needing BP control but also in populations with limited locomotion that might benefit from post-exercise hypotension.",2020,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","['young men with elevated BP', 'Eleven young men with elevated BP completed either a']","['Battling rope (BTR) exercise', 'BTR or a non-exercise control', 'acute BTR exercise', 'BTR exercise']","['systolic BP and diastolic BP', 'sympathovagal balance', 'heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF', 'Cardiac Autonomic and Blood Pressure Responses', 'HRV and BP', 'heart rate variability (HRV) and blood pressure (BP) responses', 'vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",11.0,0.10577,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","[{'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States. Electronic address: awong@marymount.edu.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Bergen', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nordvall', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Allnutt', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113167']
2729,32900662,"Comparative Safety, Bioavailability, and Pharmacokinetics of Oral Dexamethasone, 4-mg and 20-mg Tablets, in Healthy Volunteers Under Fasting and Fed Conditions: A Randomized Open-label, 3-way Crossover Study.","BACKGROUND
Glucocorticoids, particularly dexamethasone, are often used in combination with novel agents in multiple myeloma. This study compared the safety, rate, and extent of absorption of a single dose of an orally administered 20-mg dexamethasone tablet to five 4-mg tablets (total, 20 mg).
PATIENTS AND METHODS
This was a single-center, open-label, randomized, 3-way crossover comparative study. Thirty-six volunteers received at least 1 dose of either a single 20-mg dexamethasone tablet, under fasting or fed conditions, or five 4-mg dexamethasone tablets (total, 20 mg). Blood samples were collected before study drug administration and at 21 time points for up to 36 hours after drug administration.
RESULTS
Mean area under the concentration-time curve from time zero to the time of last non-zero concentration (AUC 0-t ), mean area under the concentration-time curve from time zero to infinity (extrapolated) (AUC 0-∞ ), and maximum observed concentration (C max ) were 1314.38 ng × h/mL, 1329.24 ng × h/mL, and 257.22 ng/mL, respectively for fasting test formulation (single dexamethasone 20-mg tablet), 1339.74 ng × h/mL, 1358.07 ng × h/mL, and 194.56 ng/mL, respectively, for the fed test formulation (single dexamethasone 20-mg tablet), and 1325.12 ng × h/mL, 1342.12 ng × h/mL, and 244.12 ng/mL, respectively, for the reference formulation (5 dexamethasone 4-mg tablets). The median time of observed C max was 0.997 hours for the fasting and 2.502 hours for the fed test formulation, compared with 1.495 hours for the reference. Mean plasma elimination half-lives (t 1/2 ) were 4.0 hours (test fasting), 4.03 hours (test fed), and 3.96 hours (reference). The point estimates and 90% confidence intervals (CIs) for AUC 0-t , AUC 0-∞ , and C max were 99.37% (90% CI, 95.65%-103.24%), 99.24% (90% CI, 95.47%-103.16%), and 106.28% (90% CI, 97.69%-115.62%), respectively, satisfying the bioequivalence criteria of the United States Food and Drug Administration guidelines.
CONCLUSION
The 2 formulations were well-tolerated, and one 20-mg tablet or five 4-mg tablets of dexamethasone are bioequivalent under fasting conditions and thus may be prescribed interchangeably.",2020,"Mean plasma elimination half-lives (t 1/2 ) were 4.0 hours (test fasting), 4.03 hours (test fed), and 3.96 hours (reference).","['Healthy Volunteers', 'Thirty-six volunteers']","['Oral Dexamethasone, 4-mg and 20-mg Tablets', 'dexamethasone', 'Under Fasting and Fed Conditions', 'dexamethasone tablet, under fasting or fed conditions, or five 4-mg dexamethasone tablets']","['median time of observed C max', 'Comparative Safety, Bioavailability, and Pharmacokinetics', 'Mean plasma elimination half-lives']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0360528', 'cui_str': 'Dexamethasone-containing product in oral dose form'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1245770', 'cui_str': 'Dexamethasone Oral Tablet'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]",36.0,0.0866841,"Mean plasma elimination half-lives (t 1/2 ) were 4.0 hours (test fasting), 4.03 hours (test fed), and 3.96 hours (reference).","[{'ForeName': 'Qaiser', 'Initials': 'Q', 'LastName': 'Bashir', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: QBashir@mdanderson.org.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Acosta', 'Affiliation': 'Acrotech BioPharma, Irvine, CA.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2020.06.022']
2730,32907603,A qualitative assessment of factors influencing implementation and sustainability of evidence-based tobacco use treatment in Vietnam health centers.,"BACKGROUND
Effective strategies are needed to increase implementation and sustainability of evidence-based tobacco dependence treatment (TDT) in public health systems in low- and middle-income countries (LMICs). Our two-arm cluster randomized controlled trial (VQuit) found that a multicomponent implementation strategy was effective in increasing provider adherence to TDT guidelines in commune health center (CHCs) in Vietnam. In this paper, we present findings from a post-implementation qualitative assessment of factors influencing effective implementation and program sustainability.
METHODS
We conducted semi-structured qualitative interviews (n = 52) with 13 CHC medical directors (i.e., physicians), 25 CHC health care providers (e.g., nurses), and 14 village health workers (VHWs) in 13 study sites. Interviews were transcribed and translated into English. Two qualitative researchers used both deductive (guided by the Consolidated Framework for Implementation Research) and inductive approaches to analysis.
RESULTS
Facilitators of effective implementing of TDT included training and point-of-service tools (e.g., desktop chart with prompts for offering brief counseling) that increased knowledge and self-efficacy, patient demand for TDT, and a referral system, available in arm 2, which reduced the provider burden by shifting more intensive cessation counseling to a trained VHW. The primary challenges to sustainability were competing priorities that are driven by the Ministry of Health and may result in fewer resources for TDT compared with other health programs. However, providers and VHWs suggested several options for adapting the intervention and implementation strategies to address challenges and increasing engagement of local government committees and other sectors to sustain gains.
CONCLUSION
Our findings offer insights into how a multicomponent implementation strategy influenced changes in the delivery of evidence-based TDT. In addition, the results illustrate the dynamic interplay between barriers and facilitators for sustaining TDT at the policy and community/practice level, particularly in the context of centralized public health systems like Vietnam's. Sustaining gains in practice improvement and clinical outcomes will require strategies that include ongoing engagement with policymakers and other stakeholders at the national and local level, and planning for adaptations and subsequent resource allocations in order to meet the World Health Organization's goals promoting access to effective treatment for all tobacco users.
TRIAL REGISTRATION
NCT02564653 , registered September 2015.",2020,Our findings offer insights into how a multicomponent implementation strategy influenced changes in the delivery of evidence-based TDT.,"['commune health center (CHCs) in Vietnam', 'n = 52) with 13 CHC medical directors (i.e., physicians), 25 CHC health care providers (e.g., nurses), and 14 village health workers (VHWs) in 13 study sites', 'Vietnam health centers']",['semi-structured qualitative interviews'],"['knowledge and self-efficacy, patient demand for TDT']","[{'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C1861453', 'cui_str': 'Pseudohyperkalemia Cardiff'}, {'cui': 'C0025081', 'cui_str': 'Medical Directors'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0087157', 'cui_str': 'Village Health Worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040332', 'cui_str': 'Tobacco dependence syndrome'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",52.0,0.0538565,Our findings offer insights into how a multicomponent implementation strategy influenced changes in the delivery of evidence-based TDT.,"[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'VanDevanter', 'Affiliation': 'Rory Myers College of Nursing, New York University, 433 First Avenue, New York, NY, 10010, USA.'}, {'ForeName': 'Milkie', 'Initials': 'M', 'LastName': 'Vu', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Department of Population Health, NYU Langone Health, 180 Madison Ave., 17th floor, New York, NY, 10016, USA.'}, {'ForeName': 'Trang', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Social and Medical Studies, 810 CT1A ĐN1, Ham Nghi Street, My Dinh 2 Ward, South Tu Liem District, Hanoi, Vietnam.'}, {'ForeName': 'Hoang', 'Initials': 'H', 'LastName': 'Van Minh', 'Affiliation': 'Hanoi University of Public Health, No 1A Duc Thang Street, Duc Thang Ward, North Tu Liem District, Hanoi, Vietnam.'}, {'ForeName': 'Nam Truong', 'Initials': 'NT', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Social and Medical Studies, 810 CT1A ĐN1, Ham Nghi Street, My Dinh 2 Ward, South Tu Liem District, Hanoi, Vietnam.'}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'Shelley', 'Affiliation': 'Department of Public Health Policy and Management, School of Global Public Health, New York University, 715 Broadway, New York, NY, 10012, USA. ds186@nyu.edu.'}]",Implementation science : IS,['10.1186/s13012-020-01035-6']
2731,32906135,Tubular Biomarkers and Chronic Kidney Disease Progression in SPRINT Participants.,"BACKGROUND
Kidney tubular atrophy on biopsy is a strong predictor of chronic kidney disease (CKD) progression, but tubular health is poorly quantified by traditional measures including estimated glomerular filtration rate (eGFR) and albuminuria. We hypothesized that urinary biomarkers of impaired tubule function would be associated with faster eGFR declines in persons with CKD.
METHODS
We measured baseline urine concentrations of uromodulin, β2-microglobulin (β2m), and α1-microglobulin (α1m) among 2,428 participants of the Systolic Blood Pressure Intervention Trial with an eGFR <60 mL/min/1.73 m2. We used linear mixed models to evaluate biomarker associations with annualized relative change in eGFR, stratified by randomization arm.
RESULTS
At baseline, the mean age was 73 ± 9 years and eGFR was 46 ± 11 mL/min/1.73 m2. In the standard blood pressure treatment arm, each 2-fold higher urinary uromodulin was associated with slower % annual eGFR decline (0.34 [95% CI: 0.08, 0.60]), whereas higher urinary β2m was associated with faster % annual eGFR decline (-0.10 [95% CI: -0.18, -0.02]) in multivariable-adjusted models including baseline eGFR and albuminuria. Associations were weaker and did not reach statistical significance in the intensive blood pressure treatment arm for either uromodulin (0.11 [-0.13, 0.35], p value for interaction by treatment arm = 0.045) or β2m (-0.01 [-0.08, 0.08], p value for interaction = 0.001). Urinary α1m was not independently associated with eGFR decline in the standard (0.01 [-0.22, 0.23]) or intensive (0.03 [-0.20, 0.25]) arm.
CONCLUSIONS
Among trial participants with hypertension and CKD, baseline measures of tubular function were associated with subsequent declines in kidney function, although these associations were diminished by intensive blood pressure control.",2020,"In the standard blood pressure treatment arm, each 2-fold higher urinary uromodulin was associated with slower % annual eGFR decline (0.34 [95% CI: 0.08, 0.60]), whereas higher urinary β2m was associated with faster % annual eGFR decline (-0.10","['2,428 participants of the Systolic Blood Pressure Intervention Trial with an eGFR <60 mL/min/1.73 m2', 'persons with CKD', 'SPRINT Participants']",[],"['baseline urine concentrations of uromodulin, β2-microglobulin (β2m), and α1-microglobulin (α1m', 'Tubular Biomarkers and Chronic Kidney Disease Progression', 'annual eGFR decline', 'eGFR decline', 'intensive blood pressure control', 'kidney function', 'Urinary α1m', 'glomerular filtration rate (eGFR) and albuminuria']","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0077918', 'cui_str': 'Uromucoid protein'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]",2428.0,0.0823971,"In the standard blood pressure treatment arm, each 2-fold higher urinary uromodulin was associated with slower % annual eGFR decline (0.34 [95% CI: 0.08, 0.60]), whereas higher urinary β2m was associated with faster % annual eGFR decline (-0.10","[{'ForeName': 'Vasantha', 'Initials': 'V', 'LastName': 'Jotwani', 'Affiliation': 'Department of Medicine, San Francisco VA Medical Health Care System, San Francisco, California, USA, vasantha.jotwani@ucsf.edu.'}, {'ForeName': 'Pranav S', 'Initials': 'PS', 'LastName': 'Garimella', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bates', 'Affiliation': 'Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Drawz', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Department of Medicine, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Killeen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'Punzi Medical Center, Trinity Hypertension Research Institute, Carollton, Texas, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sarnak', 'Affiliation': 'Department of Medicine, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Segal', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Department of Medicine, San Francisco VA Medical Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of nephrology,['10.1159/000509978']
2732,32913166,"The effect of kinesio taping with the web strip technique on pain, edema, and trismus after impacted mandibular third molar surgery.","Backgound
There are many methods used to alleviate edema, trismus, and pain after impacted third molar (3M) removal, one of which is Kinesio Taping (KT).
Aims
This study aimed to evaluate the effectiveness of Kinesio Taping with Web Strip technique on postoperative morbidity after impacted mandibular 3M extraction.
Methods
The study employed a split-mouth and controlled randomized clinical trial design. A total of 60 patients were scheduled for surgical extractions of bilateral lower 3Ms. They were randomly divided into two groups, and KT was applied to one group while the others was determined as a control group without KT application. Tape was applied directly after surgery and maintained for postoperative (post-op) 7 days. Pain intensity was recorded subjectively using a Visual Analogue Scale (VAS). Pain and analgesic usage were recorded on the post-op 1 st , 2 nd , 3 rd , and 7 th days. Trismus was evaluated before the surgery and on the post-op 2 nd and 7 th days. Facial edema was analyzed on the post-op 2 nd and 7 th days by VAS and by measuring the lengths of three lines using a flexible plastic tape measure.
Results
VAS pain scores were statistically lower in the KT group on the post-op 1 st , 3 rd and 7 th days. Total analgesic usage was also significantly lower in the KT group. On the post-op 2 nd day, measurement of the lengths of three lines showed a statistically less edema in the KT group. Similar results were obtained from the measurement of edema using VAS. Maximum mouth opening was statistically higher in the KT group on the post-op 2 nd and 7 th day.
Conclusion
KT with the web strip technique should be considered more economic and less traumatic than other approaches, as it is free from systemic side effects and is a simple method to carry out to decrease morbidity.",2020,"Results
VAS pain scores were statistically lower in the KT group on the post-op 1 st , 3 rd and 7 th days.","['60 patients were scheduled for surgical extractions of bilateral lower 3Ms', 'after impacted mandibular third molar surgery']","['control group without KT application', 'kinesio taping with the web strip technique', 'Backgound', 'Kinesio Taping with Web Strip technique']","['edema', 'Maximum mouth opening', 'pain, edema, and trismus', 'Trismus', 'Total analgesic usage', 'Pain intensity', 'Visual Analogue Scale (VAS', 'VAS pain scores', 'Pain and analgesic usage', 'postoperative morbidity', 'Facial edema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1293139', 'cui_str': 'Surgical extraction'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0542571', 'cui_str': 'Edema of face'}]",60.0,0.0238633,"Results
VAS pain scores were statistically lower in the KT group on the post-op 1 st , 3 rd and 7 th days.","[{'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Yurttutan', 'Affiliation': 'Ankara University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Ankara, Turkey.'}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Sancak', 'Affiliation': 'Ankara Yildirim Beyazit University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Ankara, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_23_20']
2733,32913173,Investigation of the esthetic outcomes of white spot lesion treatments.,"Objective
The present study compared the ability of bleaching, resin infiltration and microabrasion to restore the appearance of existing white spot lesions (WSL) on tooth surfaces as close as possible to that of the original healthy enamel.
Materials and Methods
Sixty extracted human teeth with WSL were randomly assigned to three treatment groups (20/group). Prior to treatment, the colour of the surrounding healthy enamel and the WSL were measured as the baseline and pre-treatment (PreRX) colours respectively using spectrophotometer based on CIE L*A*B. The L-value was used for the statistical comparison. WSLs in each group were treated respectively by bleaching, infiltration or microabrasion following the manufacturer's instructions. Colour measurement was repeated after treatment. Both intragroup and intergroup comparisons were performed using ANOVA followed by Tukey's multiple comparison test (α=0.05).
Result
In all groups the mean L-values were significantly higher in PreRX WSL (P < 0.01; Tukey) compared to baseline (sound enamel). After treatment the difference in mean L-value between baseline and WSL increased significantly (P < 0.01, Tukey) in Bleaching and Microabrasion groups by 1.4% and 1% respectively, but decreased in Infiltration group by 3.4%. Thus resin infiltration decreased the L-value of the WSL, bringing it closer to the L-value of the sound enamel while bleaching and microabrasion increased the L-value.
Conclusions
Among the three treatment modalities investigated in this study, resin infiltration was the most effective in masking the WSLs.",2020,In all groups the mean L-values were significantly higher in PreRX WSL (P < 0.01; Tukey) compared to baseline (sound enamel).,['Materials and Methods\n\n\nSixty extracted human teeth with WSL'],[],"['mean L-value', 'mean L-values']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0184942,In all groups the mean L-values were significantly higher in PreRX WSL (P < 0.01; Tukey) compared to baseline (sound enamel).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Developmental Dentistry, School of Dentistry, University of Texas Health San Antonio, Texas, USA.'}, {'ForeName': 'L O', 'Initials': 'LO', 'LastName': 'Okoye', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, College of Medicine, University of Nigeria, Enugu, Nigeria.'}, {'ForeName': 'P P', 'Initials': 'PP', 'LastName': 'Lima', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, Texas, USA.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Gakunga', 'Affiliation': 'Department of Developmental Dentistry, School of Dentistry, University of Texas Health San Antonio, Texas, USA.'}, {'ForeName': 'B T', 'Initials': 'BT', 'LastName': 'Amaechi', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, Texas, USA.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_119_20']
2734,32915891,Effect of the trajectory of exertional breathlessness on symptom recall and anticipation: A randomized controlled trial.,"BACKGROUND
Breathlessness is a major cause of physical limitation. Recalled breathlessness intensity may differ from experienced intensity and be influenced by the intensity trajectory including the 'peak-end rule'. The primary aim was to test if adding two minutes of low intensity exercise at the end of an exercise test would change the recalled breathlessness. Secondary aims included to analyse the impact of the peak and end exertional breathlessness intensity on breathlessness recall.
METHODS
Randomized controlled trial of 92 adults referred for exercise testing who were randomized (1:1), at test end, to 2 minutes of additional low intensity exercise (intervention; n = 47) or stopping at peak exertion (control; n = 45). Experienced breathlessness during the test and recalled intensity (30 min after the test) was assessed using the Borg CR10 scale.
RESULTS
Participants were aged a mean 59 years; 61% men; 79% reported a mMRC ≥1. There was no between-group difference in recalled breathlessness intensity, 5.51 ([95% CI] 5.00 to 6.01) vs. 5.73 (5.27 to 6.20; p = 0.52) in controls, even though the intervention group had a significantly lower end breathlessness (mean difference 0.96; 0.24 to 1.67; p = 0.009). Recalled exertional breathlessness was most strongly related to peak breathlessness (r2 = 0.43). When analyzed together, end breathlessness did not add any explanatory value above that of peak breathlessness.
CONCLUSION
Adding an episode of two minutes of lower exercise and breathlessness intensity at the end of an exercise test did not affect symptom recall, which was most strongly related to peak breathlessness intensity.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT03468205).",2020,"There was no between-group difference in recalled breathlessness intensity, 5.51 ([95% CI] 5.00 to 6.01) vs. 5.73 (5.27 to 6.20; p = 0.52) in controls, even though the intervention group had a significantly lower end breathlessness (mean difference 0.96; 0.24 to 1.67; p = 0.009).","['92 adults referred for exercise testing', 'Participants were aged a mean 59 years; 61% men; 79% reported a mMRC ≥1']","['low intensity exercise', 'additional low intensity exercise (intervention; n = 47) or stopping at peak exertion']","['symptom recall and anticipation', 'peak breathlessness', 'recalled breathlessness intensity', 'Recalled breathlessness intensity', 'end breathlessness', 'Experienced breathlessness', 'Recalled exertional breathlessness', 'peak and end exertional breathlessness intensity on breathlessness recall']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0444930', 'cui_str': 'End'}]",92.0,0.194385,"There was no between-group difference in recalled breathlessness intensity, 5.51 ([95% CI] 5.00 to 6.01) vs. 5.73 (5.27 to 6.20; p = 0.52) in controls, even though the intervention group had a significantly lower end breathlessness (mean difference 0.96; 0.24 to 1.67; p = 0.009).","[{'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Elmberg', 'Affiliation': 'Department of Clinical Physiology, Blekinge Hospital, Karlskrona, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekström', 'Affiliation': 'Department of Clinical Sciences Lund, Respiratory Medicine and Allergology, Faculty of Medicine, Lund University, Lund, Sweden.'}]",PloS one,['10.1371/journal.pone.0238937']
2735,32919092,"Training effects of attention and EF strategy-based training ""Nexxo"" in school-age students.","Given the importance of attention and executive functions in children's behavior, programs directed to improve these processes are of interest. Nexxo-training combines the use of the Nexxo touchscreen application (go/no-go and stop signal tasks) with procedural metacognitive strategies. The present paper reports a test of Nexxo's impact on children aged 6-7 and 8-9 years. We conducted a randomized active-controlled trial involving 108 typically-developing children: 1st grade (N = 61, M = 6.46 years, SD = 0.35) and 3rd grade (N = 47, M = 8.5 years, SD = 0.27), randomly assigned to: (1) experimental, (2) active-control, or (3) passive-control groups. A 2-month follow-up was carried out after the intervention. The 3rd grade experimental group displayed a significant reduction in attentional problems at follow-up compared to both control groups. Executive Function problems were also reduced at follow-up in the experimental group. Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls. Although group effect was not significant at t1, it was significant at post measures in experimental group compared to passive-controls. Nexxo-training revealed a trend-level improvement in attention and executive functions for children in the 3rd grade.",2020,Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls.,"['school-age students', '108 typically-developing children: 1st grade (N\xa0=\xa061, M\xa0=\xa06.46\xa0years, SD\xa0=\xa00.35) and 3rd grade (N\xa0=\xa047, M\xa0=\xa08.5\xa0years, SD\xa0=\xa00.27', 'children aged 6-7 and 8-9\xa0years']","['attention and EF strategy-based training ""Nexxo', 'active-control, or (3) passive-control groups', 'Nexxo-training', 'Nexxo touchscreen application (go/no-go and stop signal tasks) with procedural metacognitive strategies']","['attention and executive functions', 'Executive Function problems', 'attentional problems']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",108.0,0.0178247,Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rossignoli-Palomeque', 'Affiliation': 'Department of Basic Psychology II, Complutense University of Madrid, Madrid, Spain. Electronic address: teresa.rossignoli@ucm.es.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Perez-Hernandez', 'Affiliation': 'Department of Development and Educational Psychology, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'González-Marqués', 'Affiliation': 'Department of Basic Psychology II, Complutense University of Madrid, Madrid, Spain.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103174']
2736,32920824,An economic evaluation of the randomized controlled trial of topical corticosteroid and home-based narrowband ultraviolet B for active and limited vitiligo (the HI-Light Vitiligo Trial).,"BACKGROUND
Economic evidence for vitiligo treatments is absent.
OBJECTIVES
To determine the cost-effectiveness of (i) handheld narrowband ultraviolet B (NB-UVB) and (ii) a combination of topical corticosteroid (TCS) and NB-UVB compared with TCS alone for localized vitiligo.
METHODS
Cost-effectiveness analysis alongside a pragmatic, three-arm, placebo-controlled randomized controlled trial with 9 months' treatment. In total 517 adults and children (aged ≥ 5 years) with active vitiligo affecting < 10% of skin were recruited from secondary care and the community and were randomized 1: 1: 1 to receive TCS, NB-UVB or both. Cost per successful treatment (measured on the Vitiligo Noticeability Scale) was estimated. Secondary cost-utility analyses measured quality-adjusted life-years using the EuroQol 5 Dimensions 5 Levels for those aged ≥ 11 years and the Child Health Utility 9D for those aged 5 to < 18 years. The trial was registered with number ISRCTN17160087 on 8 January 2015.
RESULTS
The mean ± SD cost per participant was £775 ± 83·7 for NB-UVB, £813 ± 111.4 for combination treatment and £600 ± 96·2 for TCS. In analyses adjusted for age and target patch location, the incremental difference in cost for combination treatment compared with TCS was £211 (95% confidence interval 188-235), corresponding to a risk difference of 10·9% (number needed to treat = 9). The incremental cost was £1932 per successful treatment. The incremental difference in cost for NB-UVB compared with TCS was £173 (95% confidence interval 151-196), with a risk difference of 5·2% (number needed to treat = 19). The incremental cost was £3336 per successful treatment.
CONCLUSIONS
Combination treatment, compared with TCS alone, has a lower incremental cost per additional successful treatment than NB-UVB only. Combination treatment would be considered cost-effective if decision makers are willing to pay £1932 per additional treatment success.",2020,"Mean (SD) cost per participant was £774.4 (83.71) for NB-UVB, £813.38 (111.39) for combination treatment and £599.98",['517 Adults and children (aged ≥5 years) with active vitiligo affecting <10% of skin recruited from secondary care and community'],"['TCS', 'TCS; NB-UVB', 'placebo-controlled RCT', ' hand-held narrowband-UVB (NB-UVB) and (b) combination of topical corticosteroid (TCS) and NB-UVB', 'topical corticosteroid and home-based narrowband UVB']","['Incremental cost', 'Vitiligo Noticeability Scale', 'Mean (SD) cost', 'cost for NB-UVB']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}]",517.0,0.296467,"Mean (SD) cost per participant was £774.4 (83.71) for NB-UVB, £813.38 (111.39) for combination treatment and £599.98","[{'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Sach', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Thomas', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Batchelor', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Perways', 'Affiliation': 'Department of Medical Physics and Clinical Engineering, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Chalmers', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Haines', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Meakin', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Duley', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Ravenscroft', 'Affiliation': ""Department of Paediatric Dermatology, Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust, Nottingham, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'Department of Medical Physics and Clinical Engineering, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Santer', 'Affiliation': 'Primary Care, Population Sciences & Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Whitton', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Williams', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Cheung', 'Affiliation': 'Cannock Chase Hospital and New Cross Hospital, The Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hamad', 'Affiliation': 'Cannock Chase Hospital and New Cross Hospital, The Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': ""St Luke's Hospital, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.""}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Ingram', 'Affiliation': 'Division of Infection and Immunity, Cardiff University, Cardiff, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Levell', 'Affiliation': 'Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'J M R', 'Initials': 'JMR', 'LastName': 'Goulding', 'Affiliation': 'Solihull Hospital, University Hospitals of Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Makrygeorgou', 'Affiliation': 'West Glasgow Ambulatory Care Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bewley', 'Affiliation': 'Whipps Cross Hospital and The Royal London Hospital, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ogboli', 'Affiliation': ""Birmingham Children's Hospital, Birmingham Children's Hospital NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stainforth', 'Affiliation': 'York Hospital, York Teaching Hospital NHS Foundation Trust, York, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ferguson', 'Affiliation': 'Royal Derby Hospital and the London Road Community Hospital, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Laguda', 'Affiliation': 'Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wahie', 'Affiliation': 'University Hospital of North Durham, County Durham and Darlington NHS Foundation Trust, Durham, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ellis', 'Affiliation': 'The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Azad', 'Affiliation': 'The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rajasekaran', 'Affiliation': 'Birmingham City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Eleftheriadou', 'Affiliation': 'Leicester Royal Infirmary, Leicester, UK.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Montgomery', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of dermatology,['10.1111/bjd.19554']
2737,32920957,36-month LipiDiDiet multinutrient clinical trial in prodromal Alzheimer's disease.,"INTRODUCTION
The LipiDiDiet trial investigates the effects of the specific multinutrient combination Fortasyn Connect on cognition and related measures in prodromal Alzheimer's disease (AD). Based on previous results we hypothesized that benefits increase with long-term intervention.
METHODS
In this randomized, double-blind, placebo-controlled trial, 311 people with prodromal AD were recruited using the International Working Group-1 criteria and assigned to active product (125 mL once-a-day drink) or an isocaloric, same tasting, placebo control drink. Main outcome was change in cognition (Neuropsychological Test Battery [NTB] 5-item composite). Analyses were by modified intention-to-treat, excluding (ie, censoring) data collected after the start of open-label active product and/or AD medication.
RESULTS
Of the 382 assessed for eligibility, 311 were randomized, of those 162 participants completed the 36-month study, including 81 with 36-month data eligible for efficacy analysis. Over 36 months, significant reductions in decline were observed for the NTB 5-item composite (-60%; between-group difference 0.212 [95% confidence interval: 0.044 to 0.380]; P = 0.014), Clinical Dementia Rating-Sum of Boxes (-45%; P = 0.014), memory (-76%; P = 0.008), and brain atrophy measures; small to medium Cohen's d effect size (0.25-0.31) similar to established clinically relevant AD treatment.
DISCUSSION
This multinutrient intervention slowed decline on clinical and other measures related to cognition, function, brain atrophy, and disease progression. These results indicate that intervention benefits increased with long-term use.",2020,"This multinutrient intervention slowed decline on clinical and other measures related to cognition, function, brain atrophy, and disease progression.","[""prodromal Alzheimer's disease"", 'Of the 382 assessed for eligibility', ""prodromal Alzheimer's disease (AD"", '162 participants completed the 36-month study, including 81 with 36-month data eligible for efficacy analysis', '311 people with prodromal AD']","['specific multinutrient combination Fortasyn Connect', 'placebo', 'International Working Group-1 criteria and assigned to active product (125 mL once-a-day drink) or an isocaloric, same tasting, placebo control drink']","['change in cognition (Neuropsychological Test Battery [NTB] 5-item composite', 'Clinical Dementia Rating-Sum of Boxes', 'NTB 5-item composite', 'cognition, function, brain atrophy, and disease progression']","[{'cui': 'C3805054', 'cui_str': ""Prodromal Alzheimer's disease""}, {'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4309713', 'cui_str': 'Fortasyn Connect'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0451074', 'cui_str': 'Clinical dementia rating scale'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",311.0,0.597622,"This multinutrient intervention slowed decline on clinical and other measures related to cognition, function, brain atrophy, and disease progression.","[{'ForeName': 'Hilkka', 'Initials': 'H', 'LastName': 'Soininen', 'Affiliation': 'Department of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'Department of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Pieter Jelle', 'Initials': 'PJ', 'LastName': 'Visser', 'Affiliation': 'Department of Neurology, Alzheimer Center, Amsterdam Neuroscience, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Suzanne B', 'Initials': 'SB', 'LastName': 'Hendrix', 'Affiliation': 'Pentara Corporation, Millcreek, Utah, USA.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Blennow', 'Affiliation': 'Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at University of Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Kivipelto', 'Affiliation': 'Department of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hartmann', 'Affiliation': 'Deutsches Institut für Demenz Prävention (DIDP), Medical Faculty, Saarland University, Kirrbergerstraße, Homburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1002/alz.12172']
2738,32923171,"Adjuvant MUC vaccination with tecemotide after resection of colorectal liver metastases: a randomized, double-blind, placebo-controlled, multicenter AIO phase II trial (LICC).","Resection of colorectal liver metastases (CRLM) is a potential curative treatment for patients with metastatic colorectal cancer (mCRC) with liver-limited disease (LLD). Although long-term survival improved considerably within the last decades, high recurrence rates of 50-75% after resection remain a major challenge.Tecemotide (L-BLP25) is an antigen-specific cancer vaccine inducing immunity against mucin-1 (MUC1). The LICC trial aimed to improve survival in patients with mCRC after R0/R1 resection of CRLM. LICC was a binational, randomized, double-blind, placebo-controlled, multicenter phase 2 study including patients with R0/R1 resected CRLM without evidence of metastatic disease outside the liver. Co-primary endpoints were recurrence-free survival (RFS) and 3-year overall survival (OS) rate, secondary endpoints were RFS and OS in subgroups with different MUC1 expression and safety. In total, 121 patients were 2:1 randomized between Oct 2011 and Dec 2014to receive tecemotide (N=79) or placebo (N=42). Baseline characteristics were well balanced. Median RFS was 6.1 months (95% CI 4.5-8.9) and 11.4 months (95% CI 3.7-21.2) ( P = .1754), 3-year OS rate 69.1% and 79.1%, median OS 62.8 months and not reached in the tecemotide vs. placebo arm ( P = .2141), respectively. Cox regression models revealed no dependence of RFS or OS on MUC1 expression. The most common tecemotide-related grade 3/4 adverse events were diarrhea, injection site reaction, intestinal perforation, peritonitis and tinnitus (1.3% each). The LICC trial failed to meet its primary endpoints of significantly improving RFS and OS with tecemotide. However, both arms showed unexpectedly long OS. MUC1 expression was not associated with outcome.EudraCT No: 2011-000218-20Clinical Trial Information: NCT01462513Financial Support: Merck KGaA, Darmstadt, Germany.
Abbreviations
AE: adverse event; CP: cyclophosphamide; CRC: colorectal cancer; CT: computed tomography; ECOG: Eastern Cooperative Oncology Group; FU: follow-up; HR: hazard ratio; IHC: immunohistochemical staining; ITT: intention-to-treat; DSMB: Data Safety Monitoring Board; LLD: liver-limited disease; mCRC: metastatic colorectal cancer; MPLA: monophosphoryl lipid; AMRI: magnetic resonance imaging; MUC1: mucin 1; NA: not applicable; NCI-CTCAE: National Cancer Institute Common Terminology Criteria for Adverse Events; NS: normal saline; NSCLC: non-small-cell lung carcinoma; OS: overall surviva; lPP: per protocol; RAS: Rat sarcoma; RFS: recurrence-free survival; TEAE: treatment-emergent adverse event; UICC: Union for International Cancer Control; US: ultrasound; vs.: versus.",2020,"The most common tecemotide-related grade 3/4 adverse events were diarrhea, injection site reaction, intestinal perforation, peritonitis and tinnitus (1.3% each).","['patients with mCRC after R0/R1 resection of CRLM', 'patients with R0/R1 resected CRLM without evidence of metastatic disease outside the liver', '121 patients were 2:1 randomized between Oct 2011 and Dec 2014to receive', 'patients with metastatic colorectal cancer (mCRC) with liver-limited disease (LLD', 'colorectal liver metastases', ' 2011-000218-20Clinical Trial Information']","['LICC', 'tecemotide', 'Tecemotide (L-BLP25', 'Adjuvant MUC vaccination with tecemotide', 'saline; NSCLC', 'CP: cyclophosphamide; CRC', 'placebo', 'Resection of colorectal liver metastases (CRLM', 'EudraCT']","['3-year OS rate', 'diarrhea, injection site reaction, intestinal perforation, peritonitis and tinnitus', 'MUC1 expression', 'recurrence rates', 'recurrence-free survival (RFS) and 3-year overall survival (OS) rate, secondary endpoints were RFS and OS in subgroups with different MUC1 expression and safety', 'Median RFS', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3888078', 'cui_str': 'tecemotide'}, {'cui': 'C1832016', 'cui_str': 'L-BLP25'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0021845', 'cui_str': 'Perforation of intestine'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0006611', 'cui_str': 'Cancer antigen 15-3'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",121.0,0.76445,"The most common tecemotide-related grade 3/4 adverse events were diarrhea, injection site reaction, intestinal perforation, peritonitis and tinnitus (1.3% each).","[{'ForeName': 'Carl Christoph', 'Initials': 'CC', 'LastName': 'Schimanski', 'Affiliation': 'Medical Department 1, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kasper', 'Affiliation': 'Department of Medical Oncology, West German Cancer Center, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Hegewisch-Becker', 'Affiliation': 'Hematological and Oncological Practice Eppendorf (HOPE), Practice for Oncology, Hamburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Schröder', 'Affiliation': 'Practice for Hematology and Oncology, Müllheim a.d.R., Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Overkamp', 'Affiliation': 'Oncologianova GmbH Recklinghausen, Recklinghausen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kullmann', 'Affiliation': 'Department of Medicine I, Nordoberpfalz Clinics AG, Weiden i.d.O, Germany.'}, {'ForeName': 'Wolf Otto', 'Initials': 'WO', 'LastName': 'Bechstein', 'Affiliation': 'Department of General and Visceral Surgery, Frankfurt University Hospital and Clinics, Frankfurt, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Vöhringer', 'Affiliation': 'Department of Hematology and Oncology, Robert Bosch Hospital, Stuttgart, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Öllinger', 'Affiliation': 'Department of Surgery, Campus Charité Mitte and Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lordick', 'Affiliation': 'University Cancer Center Leipzig (UCCL), University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Center, University Hospital Grosshadern, Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Geißler', 'Affiliation': 'Department of Internal Medicine, Oncology/Hematology, Gastroenterology, Hospital Esslingen GmbH, Esslingen, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Schulz-Abelius', 'Affiliation': 'Department of Hematology and Oncology, Hospital Altenburger Land GmbH, Altenburg, Germany.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Bernhard', 'Affiliation': 'Department of Hematology/Oncology, Klinikum Darmstadt GmbH, Darmstadt, Germany.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Schön', 'Affiliation': 'Clinic of Visceral Surgery, Municipal Hospital Karlsruhe gGmbH, Karlsruhe, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-CCCIT, Cancer Cluster, Salzburg, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Galle', 'Affiliation': 'Medical Department 1, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Hauke', 'Initials': 'H', 'LastName': 'Lang', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital of Mainz, Mainz, Germany.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Schmidtmann', 'Affiliation': 'Institute for Medical Biostatistics, Epidemiology and Informatics, Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'Medical Department 1, Johannes Gutenberg University, Mainz, Germany.'}]",Oncoimmunology,['10.1080/2162402X.2020.1806680']
2739,32919855,Stereoscopic Display Is Superior to Conventional Display for Three-Dimensional Echocardiography of Congenital Heart Anatomy.,"BACKGROUND
Three-dimensional echocardiography (3DE) improves visualization of cardiac lesions. Current viewing of 3DE studies on a conventional display diminishes the encoded stereoscopic (stereo) information for depth perception. This study aims to evaluate clinician subjective and objective experience of stereo display compared with nonstereo display of 3DE in congenital heart disease.
METHODS
In this prospective study, 22 cardiologists, advanced cardiology trainees, and cardiothoracic surgeons used a commercially available stereo display system with proprietary software to view 10 3DE data sets, alternating between simple and complex lesions. In part A, participants viewed each data set, randomized to 1 minute of stereo display followed by 1 minute of nonstereo display, or vice versa. In part B, participants could freely toggle between stereo and nonstereo display for an additional 90 seconds per data set. Participants answered a series of questions and rated their subjective experience using stereo versus nonstereo display mode on a Likert scale. Objective data on time spent in each display mode during part B and duration of interaction and degree of movement of the 3DE data set in parts A and B were also collected.
RESULTS
All clinician groups found stereo display preferable to nonstereo display of 3DE (P < .0001). Viewing complex lesions was rated lower than simple lesions when using nonstereo display (P < .01). Simple and complex lesions were equally well rated when using stereo display (P = .14). When given a choice of display modes in part B, participants spent more time in stereo display (P < .0001) and interacted more with the 3DE data sets in stereo display (P < .0001).
CONCLUSIONS
Interactive stereoscopic display of 3DE was preferred over conventional nonstereo display by all clinician groups for viewing both simple and complex lesions. This preference is especially true for viewing complex lesions.",2020,"When given a choice of display modes in part B, participants spent more time in stereo display (P < .0001) and interacted more with the 3DE data sets in stereo display (P < .0001).
","['22 cardiologists, advanced cardiology trainees, and cardiothoracic surgeons']","['dimensional echocardiography (3DE', 'nonstereo display of 3DE']",['visualization of cardiac lesions'],"[{'cui': 'C0175906', 'cui_str': 'Cardiologist'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0586887', 'cui_str': 'Cardiothoracic surgeon'}]","[{'cui': 'C0013516', 'cui_str': 'Echocardiography'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",,0.029019,"When given a choice of display modes in part B, participants spent more time in stereo display (P < .0001) and interacted more with the 3DE data sets in stereo display (P < .0001).
","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Harake', 'Affiliation': ""Stollery Children's Hospital and University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Ganesh Kumar', 'Initials': 'GK', 'LastName': 'Gnanappa', 'Affiliation': ""Stollery Children's Hospital and University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Silvia G V', 'Initials': 'SGV', 'LastName': 'Alvarez', 'Affiliation': ""Stollery Children's Hospital and University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Whittle', 'Affiliation': 'Radiology and Diagnostic Imaging, University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kumaradevan', 'Initials': 'K', 'LastName': 'Punithakumar', 'Affiliation': 'Radiology and Diagnostic Imaging, University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Boechler', 'Affiliation': 'Educational Psychology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Noga', 'Affiliation': 'Radiology and Diagnostic Imaging, University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Nee Scze', 'Initials': 'NS', 'LastName': 'Khoo', 'Affiliation': ""Stollery Children's Hospital and University of Alberta, Edmonton, Alberta, Canada. Electronic address: harake@ualberta.ca.""}]",Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography,['10.1016/j.echo.2020.06.016']
2740,32897035,Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis.,"BACKGROUND
Autoimmune pulmonary alveolar proteinosis (aPAP) is a rare disease characterized by progressive surfactant accumulation and hypoxemia. It is caused by disruption of granulocyte-macrophage colony-stimulating factor (GM-CSF) signaling, which pulmonary alveolar macrophages require to clear surfactant. Recently, inhaled GM-CSF was shown to improve the partial pressure of arterial oxygen in patients with aPAP.
METHODS
In a double-blind, placebo-controlled, three-group trial, we randomly assigned patients with aPAP to receive the recombinant GM-CSF molgramostim (300 μg once daily by inhalation), either continuously or intermittently (every other week), or matching placebo. The 24-week intervention period was followed by an open-label treatment-extension period. The primary end point was the change from baseline in the alveolar-arterial difference in oxygen concentration (A-aDo 2 ) at week 24.
RESULTS
In total, 138 patients underwent randomization; 46 were assigned to receive continuous molgramostim, 45 to receive intermittent molgramostim, and 47 to receive placebo. Invalid A-aDo 2 data for 4 patients (1 in each molgramostim group and 2 in the placebo group) who received nasal oxygen therapy during arterial blood gas measurement were replaced by means of imputation. For the primary end point - the change from baseline in the A-aDo 2 at week 24 - improvement was greater among patients receiving continuous molgramostim than among those receiving placebo (-12.8 mm Hg vs. -6.6 mm Hg; estimated treatment difference, -6.2 mm Hg; P = 0.03 by comparison of least-squares means). Patients receiving continuous molgramostim also had greater improvement than those receiving placebo for secondary end points, including the change from baseline in the St. George's Respiratory Questionnaire total score at week 24 (-12.4 points vs. -5.1 points; estimated treatment difference, -7.4 points; P = 0.01 by comparison of least-squares means). For multiple end points, improvement was greater with continuous molgramostim than with intermittent molgramostim. The percentages of patients with adverse events and serious adverse events were similar in the three groups, except for the percentage of patients with chest pain, which was higher in the continuous-molgramostim group.
CONCLUSIONS
In patients with aPAP, daily administration of inhaled molgramostim resulted in greater improvements in pulmonary gas transfer and functional health status than placebo, with similar rates of adverse events. (Funded by Savara Pharmaceuticals; IMPALA ClinicalTrials.gov number, NCT02702180.).",2020,"The percentages of patients with adverse events and serious adverse events were similar in the three groups, except for the percentage of patients with chest pain, which was higher in the continuous-molgramostim group.
","['Autoimmune Pulmonary Alveolar Proteinosis', 'patients with aPAP', '4 patients (1 in each molgramostim group and 2 in the placebo group) who received', '138 patients underwent randomization; 46 were assigned to receive']","['nasal oxygen therapy', 'Inhaled Molgramostim Therapy', 'placebo', 'continuous molgramostim, 45 to receive intermittent molgramostim, and 47 to receive placebo', 'inhaled molgramostim', 'recombinant GM-CSF molgramostim']","['alveolar-arterial difference in oxygen concentration', 'partial pressure of arterial oxygen', 'pulmonary gas transfer and functional health status', 'adverse events', 'adverse events and serious adverse events', ""St. George's Respiratory Questionnaire total score""]","[{'cui': 'C1970472', 'cui_str': 'Autoimmune pulmonary alveolar proteinosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0218633', 'cui_str': 'molgramostim'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0218633', 'cui_str': 'molgramostim'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0428646', 'cui_str': 'Oxygen concentration'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",138.0,0.336607,"The percentages of patients with adverse events and serious adverse events were similar in the three groups, except for the percentage of patients with chest pain, which was higher in the continuous-molgramostim group.
","[{'ForeName': 'Bruce C', 'Initials': 'BC', 'LastName': 'Trapnell', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bonella', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Morgan', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Jouneau', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bendstrup', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Campo', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Spyros A', 'Initials': 'SA', 'LastName': 'Papiris', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Yamaguchi', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Erdogan', 'Initials': 'E', 'LastName': 'Cetinkaya', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Mikhail M', 'Initials': 'MM', 'LastName': 'Ilkovich', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Mordechai R', 'Initials': 'MR', 'LastName': 'Kramer', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Veltkamp', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Baba', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Ganslandt', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Tarnow', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Waterer', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Taneli', 'Initials': 'T', 'LastName': 'Jouhikainen', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1913590']
2741,32901323,Prospectively Randomized Controlled Trial on Damage Control Surgery for Perforated Diverticulitis with Generalized Peritonitis.,"INTRODUCTION
Damage control surgery (DCS) with abdominal negative pressure therapy and delayed anastomosis creation in patients with perforated diverticulitis and generalized peritonitis was established at our Institution in 2006 and has been published. The concept was adopted in other hospitals and published as a case series. This is the first prospectively controlled randomized study comparing DCS and conventional treatment (Group C) in this setting.
METHODS
All consecutive patients from 2013 to 2018 with indication for surgery were screened and randomized to Group DCS or Group C. The primary outcome was the rate of reconstructed bowel at discharge and at 6 month. Informed consent was obtained. The trial was approved by the local ethics committee and registered at CinicalTrials.gov: NCT04034407.
RESULTS
A total of 56 patients were screened; 41 patients gave informed consent to participate and ultimately 21 patients (9 female) with intraoperatively confirmed Hinchey III (n = 14, 67%) or IV (n = 7, 33%), and a median (range) age of 66 (42-92), Mannheim Peritonitis Index of 25 (12-37) and Charlson Comorbidity Index of 3 (0-10) were intraoperatively randomized and treated as Group DCS (n = 13) or Group C (n = 8). Per protocol analysis: A primary anastomosis without ileostomy (PA) was performed in 92% (11/12) patients in Group DCS at the second-look operation, one patient died before second look, and one underwent a Hartmann procedure (HP). In Group C 63% (5/8) patients received a PA and 38% (3/8) patients a HP. Two patients in Group C, but none in Group DCS experienced anastomotic leakage (AI). ICU and hospital stay was median (range) 2 (1-10) and 17.5 (12-43) in DCS and 2 (1-62) and 22 (13-65) days in group C. In Group DCS 8% (1/12) patients was discharged with a stoma versus 57% (4/7) in Group C (p = 0.038, n.s., α = 0.025); one patient died before discharge. The odds ratio (95% confidence interval) for discharge with a stoma is 0.068 (0.005-0.861). Intent to treat analysis: A PA was performed in 90% (9/10) of patients randomized to DCS, one patient died before the second look, and one patient received a HP. In group C, 70% (7/10) were treated with PA and 30% (3/10) with HP. 29% (2/7) experienced AI treated with protective ileostomy. In group DCS, 9% (1/11) were discharged with a stoma versus 40% (4/10) in group C (p = 0.14, n.s.). The odds ratio for discharge with a stoma is 0.139 (0.012-1.608).
CONCLUSION
This is the first prospectively randomized controlled study showing that damage control surgery in perforated diverticulitis Hinchey III and IV enhances reconstruction of bowel continuity and can reduce the stoma rate at discharge.",2020,"patients was discharged with a stoma versus 57% (4/7) in Group C (p = 0.038, n.s., α = 0.025); one patient died before discharge.","['Perforated Diverticulitis with Generalized Peritonitis', '56 patients were screened; 41 patients gave informed consent to participate and ultimately 21 patients (9 female) with intraoperatively confirmed Hinchey III (n\u2009=\u200914, 67%) or IV (n\u2009=\u20097, 33%), and a median (range) age of 66 (42-92), Mannheim Peritonitis Index of 25 (12-37) and Charlson Comorbidity Index of 3 (0-10', 'All consecutive patients from 2013 to 2018 with indication for surgery', 'patients with perforated diverticulitis and generalized peritonitis']","['DCS', 'Hartmann procedure (HP', 'Damage Control Surgery', 'HP', 'Damage control surgery (DCS) with abdominal negative pressure therapy and delayed anastomosis creation', 'Group DCS', 'primary anastomosis without ileostomy (PA', 'Group DCS or Group C']","['rate of reconstructed bowel at discharge and at 6\xa0month', 'anastomotic leakage (AI', 'odds ratio for discharge with a stoma', 'ICU and hospital stay']","[{'cui': 'C0544794', 'cui_str': 'Perforated diverticulitis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0400084', 'cui_str': 'Hartmann operation, rectal resection'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0441513', 'cui_str': 'Construction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",56.0,0.0719085,"patients was discharged with a stoma versus 57% (4/7) in Group C (p = 0.038, n.s., α = 0.025); one patient died before discharge.","[{'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Kafka-Ritsch', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria. reinhold.kafka-ritsch@tirol-kliniken.at.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Zitt', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Perathoner', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Gasser', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Kaufman', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Czipin', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Aigner', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Öfner', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}]",World journal of surgery,['10.1007/s00268-020-05762-1']
2742,32897933,A short-term oral corticosteroid for refractory lumbar spinal stenosis: a double-blinded randomized placebo-controlled clinical trial.,"Although epidural corticosteroids have been evaluated for the lumbar spinal stenosis (LSS) as an alternative treatment, oral corticosteroids have not been considered as a possible option for the patients with constant pain who have resistant against routine treatments. Therefore, this study aimed to investigate the efficacy of the short-term, low-dose oral prednisolone for refractory LSS. In this double-blinded randomized placebo-controlled clinical trial, 100 participants with the refractory LSS were selected from the out-patient clinics; however, 7 of them excluded before randomization. The patients were randomly allocated into two groups with a 1:1 ratio: the intervention group that received 10 mg prednisolone per day for 1 week and the control group that received the exact placebo. The patients' severity of pain in terms of the numerical rating scale, ability to walk in meters, and Oswestry Disability Index (ODI) were assessed and then compared to the baseline after 2 months. The baseline variables were NS between these two groups. At the 2-month follow-up, the ability to walk in meters has increased and the severity of pain and ODI have decreased in both groups. Notably, except for the walking distance, none of the differences were statistically significant. Except for the significant change in walking distance between the groups, no other significant difference was observed in any variables when comparing the delta of each variable (after-before). One-week treatment with daily 10 mg oral prednisolone was not effective on the patients with refractory LSS in the short-term follow-up.",2020,"Except for the significant change in walking distance between the groups, no other significant difference was observed in any variables when comparing the delta of each variable (after-before).","['patients with constant pain who have resistant against routine treatments', 'refractory lumbar spinal stenosis', '100 participants with the refractory LSS were selected from the out-patient clinics; however, 7 of them excluded before randomization']","['placebo', 'corticosteroid', 'epidural corticosteroids', 'prednisolone']","['numerical rating scale, ability to walk in meters, and Oswestry Disability Index (ODI', 'walking distance', 'severity of pain and ODI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960160', 'cui_str': 'Constant pain'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",100.0,0.173433,"Except for the significant change in walking distance between the groups, no other significant difference was observed in any variables when comparing the delta of each variable (after-before).","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Akbari Aghdam', 'Affiliation': 'Department of Orthopedic Surgery.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Andalib', 'Affiliation': 'Department of Orthopedic Surgery, Kashani University Hospital.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Asadiyan Ardakani', 'Affiliation': 'Student Research Committee, School of Medicine, Isfahan University of Medical Sciences, Isfahan.'}, {'ForeName': 'Mahshid', 'Initials': 'M', 'LastName': 'Telloo', 'Affiliation': 'Department of Internal Medicine, Firoozgar University Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Sheikhbahaei', 'Affiliation': 'Student Research Committee, School of Medicine, Isfahan University of Medical Sciences, Isfahan.'}]",International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation,['10.1097/MRR.0000000000000432']
2743,32897934,Effect of a training program of overground walking on BTS gait parameters in elderly women during single and dual cognitive tasks.,"We tested the hypothesis that a regular training program might reduce gait disturbances during dual cognitive-motor tasks in elderly women. This open-label experimental study comprised 53 postmenopausal women aged over 65, who were assigned to a 10-week training program (360 min/week). A BTS SMART system examination during free walking and during dual tasks [i.e., walking while performing either a simple (SCT) or a complex (CCT) cognitive task] was performed prior to the training program and again after it had finished. After the 10-week walking training program, a significant decrease was found in the duration of single support phase, double support phase, total support phase, and gait cycle, whereas values for such BTS parameters as swing speed, step length, and gait speed increased significantly. The greatest percentage deltas between the final and initial values of the respective BTS parameters concerned swing speed and gait speed irrespective of the kind of task undertaken while measurements were taken. A cognitive task, irrespective of the level of difficulty, performed during walking had the opposite effect on step width than expected. A 10-week training program significantly improved the cadency and manner of gait in elderly women, but did not change step width. Therefore, further study is needed to estimate the usefulness of cognitive-motor training programs for significant improvement in gait coordination during dual tasks in elderly women.",2020,"A 10-week training program significantly improved the cadency and manner of gait in elderly women, but did not change step width.","['53 postmenopausal women aged over 65', 'elderly women', 'elderly women during single and dual cognitive tasks']","['walking while performing either a simple (SCT) or a complex (CCT) cognitive task', 'regular training program', '10-week training program', 'training program of overground walking']","['cadency and manner of gait', 'BTS gait parameters', 'duration of single support phase, double support phase, total support phase, and gait cycle, whereas values for such BTS parameters as swing speed, step length, and gait speed', 'gait disturbances']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0072802', 'cui_str': 'Pyruvic acid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0575081', 'cui_str': 'Abnormal gait'}]",53.0,0.0113564,"A 10-week training program significantly improved the cadency and manner of gait in elderly women, but did not change step width.","[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Hagner-Derengowska', 'Affiliation': 'Department of Physical Culture, Faculty of Earth Sciences and Spatial Management, Nicolaus Copernicus University, Toruń.'}, {'ForeName': 'Krystian', 'Initials': 'K', 'LastName': 'Kałużny', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Sciences.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kałużna', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Sciences.'}, {'ForeName': 'Walery', 'Initials': 'W', 'LastName': 'Zukow', 'Affiliation': 'Department of Physical Culture, Faculty of Earth Sciences and Spatial Management, Nicolaus Copernicus University, Toruń.'}, {'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Leis', 'Affiliation': 'Faculty of Medicine, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Toruń.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Domagalska-Szopa', 'Affiliation': 'Department of Medical Rehabilitation, Faculty of Health Sciences in Katowice, Medical University, Katowice.'}, {'ForeName': 'Bartosz', 'Initials': 'B', 'LastName': 'Kochański', 'Affiliation': 'University of Bydgoszcz, Bydgoszcz.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Budzyński', 'Affiliation': 'Department of Vascular and Internal Diseases, Faculty of Health Sciences, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Toruń, Poland.'}]",International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation,['10.1097/MRR.0000000000000434']
2744,32910353,Willingness to Participate in At-Home HIV Testing Among Young Adults Who Use Opioids in Rural Appalachia.,"New HIV infections associated with injection drug use are of major concern in rural US communities. This study explores acceptability of, consent for, and uptake of free at-home HIV testing among people who use drugs (PWUD) in one of the nation's epicenters for drug-related harms and HIV vulnerability: Rural Central Appalachia. Eligible participants were 18-35 years old, lived in Appalachian Kentucky, and reported using opioids to get high in the previous 30 days. A majority reported being likely (63.6%, 96/151) to take a free at-home HIV tests and 66.9% (101/151) consented to receive one. Among those who were randomly selected to receive a Home Access HIV-1 test kit (n = 37), 37.8% mailed in blood spots and 21.6% called to receive results. This study provides evidence that PWUD may be willing to take an at-home test, but other barriers may inhibit actual completion.",2020,"This study explores acceptability of, consent for, and uptake of free at-home HIV testing among people who use drugs (PWUD) in one of the nation's epicenters for drug-related harms and HIV vulnerability: Rural Central Appalachia.","['Young Adults', 'Rural Appalachia', 'Eligible participants were 18-35\xa0years old, lived in Appalachian Kentucky, and reported using opioids to get high in the previous 30\xa0days', ""people who use drugs (PWUD) in one of the nation's epicenters for drug-related harms and HIV vulnerability: Rural Central Appalachia""]",['Home Access HIV-1 test kit'],[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0003609', 'cui_str': 'Appalachia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}]",[],,0.0668314,"This study explores acceptability of, consent for, and uptake of free at-home HIV testing among people who use drugs (PWUD) in one of the nation's epicenters for drug-related harms and HIV vulnerability: Rural Central Appalachia.","[{'ForeName': 'April M', 'Initials': 'AM', 'LastName': 'Ballard', 'Affiliation': 'Department of Epidemiology, University of Kentucky College of Public Health, Lexington, KY, USA. april.ballard@emory.edu.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Haardöerfer', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Emory University Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Nadya', 'Initials': 'N', 'LastName': 'Prood', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Emory University Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Chukwudi', 'Initials': 'C', 'LastName': 'Mbagwu', 'Affiliation': 'Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington, KY, USA.'}, {'ForeName': 'Hannah L F', 'Initials': 'HLF', 'LastName': 'Cooper', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Emory University Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'April M', 'Initials': 'AM', 'LastName': 'Young', 'Affiliation': 'Department of Epidemiology, University of Kentucky College of Public Health, Lexington, KY, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03034-6']
2745,32913018,"Long-term safety, tolerability, and efficacy of fremanezumab in migraine: A randomized study.","OBJECTIVE
To assess the long-term safety, tolerability, and efficacy of fremanezumab, a fully humanized monoclonal antibody approved for the preventive treatment of migraine.
METHODS
A 52-week, multicenter, randomized, double-blind, parallel-group study evaluated fremanezumab monthly or quarterly in adults with chronic migraine (CM) or episodic migraine (EM). Safety and tolerability were assessed by adverse event (AE) monitoring (performed by the investigators), systematic local injection-site assessments (immediately and 1 hour after injection), laboratory/vitals assessments, and immunogenicity testing. Prespecified exploratory evaluations included change from baseline in the monthly number of migraine days, headache days of at least moderate severity, and days with any acute headache medication use. Change from baseline in headache-related disability (6-item Headache Impact Test scores) was also measured.
RESULTS
Of 1,890 patients enrolled, 551 and 559 patients with CM received quarterly and monthly dosing; 394 and 386 patients with EM received quarterly or monthly, respectively. The most commonly reported AEs were injection-site reactions (induration 33%, pain 31%, and erythema 26%). Fremanezumab reduced monthly migraine days (CM quarterly -7.2 days, CM monthly -8.0 days, EM quarterly -5.2 days, EM monthly -5.1 days) and headache days of at least moderate severity (CM quarterly -6.4 days, CM monthly -6.8 days, EM quarterly -4.4, EM monthly -4.2 days) from baseline to 12 months. Reductions in any acute headache medication use and headache-related disability were also maintained over 12 months.
CONCLUSIONS
Fremanezumab quarterly and fremanezumab monthly were well tolerated and demonstrated sustained improvements in monthly migraine days, headache days, and headache-related disability for up to 12 months in patients with migraine.
CLINICALTRIALSGOV
NCT02638103.
CLASSIFICATION OF EVIDENCE
This study provides Class IV evidence that long-term fremanezumab treatment is safe, well tolerated, and effective at sustaining reductions in monthly migraine and headache days.",2020,"Fremanezumab reduced monthly migraine days (CM quarterly, -7.2 days; CM monthly, -8.0 days; EM quarterly, -5.2 days; EM monthly, -5.1 days) and headache days of at least moderate severity (CM quarterly, -6.4 days; CM monthly, -6.8 days; EM quarterly, -4.4; EM monthly, -4.2 days) from baseline to 12 months.","['adults with chronic migraine (CM) or episodic migraine (EM', '1890 patients enrolled']","['Fremanezumab', 'fremanezumab']","['Safety and tolerability', 'laboratory/vitals assessments, and immunogenicity testing', 'monthly number of: migraine days, headache days of at least moderate severity, and days with any acute headache medication use, respectively', 'monthly migraine days, headache days, and headache-related disability', 'acute headache medication use and headache-related disability', 'headache-related disability (HIT-6 scores', 'headache days of at least moderate severity', 'adverse event (AE) monitoring (performed by the investigators), systematic local injection-site assessments']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0744633', 'cui_str': 'Acute headache'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0221208', 'cui_str': 'Injection site'}]",1890.0,0.16836,"Fremanezumab reduced monthly migraine days (CM quarterly, -7.2 days; CM monthly, -8.0 days; EM quarterly, -5.2 days; EM monthly, -5.1 days) and headache days of at least moderate severity (CM quarterly, -6.4 days; CM monthly, -6.8 days; EM quarterly, -4.4; EM monthly, -4.2 days) from baseline to 12 months.","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""From NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Jefferson Headache Center (S.D.S.), Thomas Jefferson University, Philadelphia; Teva Pharmaceutical Industries Ltd. (P.P.Y., J.M.C., X.N., R.Y.), Frazer, PA; and Mayo Clinic (D.W.D.), Phoenix, AZ. peter.goadsby@kcl.ac.uk.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': ""From NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Jefferson Headache Center (S.D.S.), Thomas Jefferson University, Philadelphia; Teva Pharmaceutical Industries Ltd. (P.P.Y., J.M.C., X.N., R.Y.), Frazer, PA; and Mayo Clinic (D.W.D.), Phoenix, AZ.""}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Yeung', 'Affiliation': ""From NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Jefferson Headache Center (S.D.S.), Thomas Jefferson University, Philadelphia; Teva Pharmaceutical Industries Ltd. (P.P.Y., J.M.C., X.N., R.Y.), Frazer, PA; and Mayo Clinic (D.W.D.), Phoenix, AZ.""}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': ""From NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Jefferson Headache Center (S.D.S.), Thomas Jefferson University, Philadelphia; Teva Pharmaceutical Industries Ltd. (P.P.Y., J.M.C., X.N., R.Y.), Frazer, PA; and Mayo Clinic (D.W.D.), Phoenix, AZ.""}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Ning', 'Affiliation': ""From NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Jefferson Headache Center (S.D.S.), Thomas Jefferson University, Philadelphia; Teva Pharmaceutical Industries Ltd. (P.P.Y., J.M.C., X.N., R.Y.), Frazer, PA; and Mayo Clinic (D.W.D.), Phoenix, AZ.""}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""From NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Jefferson Headache Center (S.D.S.), Thomas Jefferson University, Philadelphia; Teva Pharmaceutical Industries Ltd. (P.P.Y., J.M.C., X.N., R.Y.), Frazer, PA; and Mayo Clinic (D.W.D.), Phoenix, AZ.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': ""From NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Jefferson Headache Center (S.D.S.), Thomas Jefferson University, Philadelphia; Teva Pharmaceutical Industries Ltd. (P.P.Y., J.M.C., X.N., R.Y.), Frazer, PA; and Mayo Clinic (D.W.D.), Phoenix, AZ.""}]",Neurology,['10.1212/WNL.0000000000010600']
2746,32913029,Association of systemic secondary brain insults and outcome in patients with convulsive status epilepticus: A post hoc study of a randomized controlled trial.,"OBJECTIVE
To evaluate the association between systemic factors (mean arterial blood pressure, arterial partial pressures of carbon dioxide and oxygen, body temperature, natremia, and glycemia) on day 1 and neurologic outcomes 90 days after convulsive status epilepticus.
METHODS
This was a post hoc analysis of the Evaluation of Therapeutic Hypothermia in Convulsive Status Epilepticus in Adults in Intensive Care (HYBERNATUS) multicenter open-label controlled trial, which randomized 270 critically ill patients with convulsive status epilepticus requiring mechanical ventilation to therapeutic hypothermia (32°C-34°C for 24 hours) plus standard care or standard care alone between March 2011 and January 2015. The primary endpoint was a Glasgow Outcome Scale score of 5, defining a favorable outcome, 90 days after convulsive status epilepticus.
RESULTS
The 172 men and 93 women had a median age of 57 years (45-68 years). Among them, 130 (49%) had a history of epilepsy, and 59 (29%) had a primary brain insult. Convulsive status epilepticus was refractory in 86 (32%) patients, and total seizure duration was 67 minutes (35-120 minutes). The 90-day outcome was unfavorable in 126 (48%) patients. In multivariate analysis, none of the systemic secondary brain insults were associated with outcome; achieving an unfavorable outcome was associated with age >65 years (odds ratio [OR] 2.17, 95% confidence interval [CI] 1.20-3.85; p = 0.01), refractory convulsive status epilepticus (OR 2.00, 95% CI 1.04-3.85; p = 0.04), primary brain insult (OR 2.00, 95% CI 1.02-4.00; p = 0.047), and no bystander-witnessed seizure onset (OR 2.49, 95% CI 1.05-5.59; p = 0.04).
CONCLUSIONS
In our population, systemic secondary brain insults were not associated with outcome in critically ill patients with convulsive status epilepticus.
CLINICALTRIALSGOV IDENTIFIER
NCT01359332.",2020,"By multivariate analysis, none of the systemic secondary brain insults was associated with outcome; achieving an unfavorable outcome was associated with age above 65 years (OR, 2.17; 95% CI, 1.20-3.85; p = 0.01), refractory convulsive status epilepticus (OR, 2.00; 95% CI, 1.04-3.85; p = 0.04), and primary brain insult (OR, 2.00; 95% CI, 1.02-4.00; p = 0.047); and no bystander-witnessed seizure onset (OR, 2.49; 95% CI, 1.05-5.59; p = 0.04).
","['270 critically ill patients with convulsive status epilepticus requiring mechanical ventilation to therapeutic hypothermia (32-34°C for 24 hours) plus standard care or standard care alone, between March 2011 and January 2015', 'patients with convulsive status epilepticus', '172 men and 93 women had a median age of 57 years (45-68']",[],"['Glasgow Outcome Scale score of 5, defining a favorable outcome, 90 days after convulsive status epilepticus', 'total seizure duration', 'refractory convulsive status epilepticus', 'previous history of epilepsy', 'systemic factors (mean arterial blood pressure, arterial partial pressures of carbon dioxide and oxygen, body temperature, natremia, and glycemia', 'bystander-witnessed seizure onset']","[{'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0311335', 'cui_str': 'Grand mal status'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0311335', 'cui_str': 'Grand mal status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3536587', 'cui_str': 'Grand mal status epilepticus, refractory'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0455511', 'cui_str': 'H/O: epilepsy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",270.0,0.281843,"By multivariate analysis, none of the systemic secondary brain insults was associated with outcome; achieving an unfavorable outcome was associated with age above 65 years (OR, 2.17; 95% CI, 1.20-3.85; p = 0.01), refractory convulsive status epilepticus (OR, 2.00; 95% CI, 1.04-3.85; p = 0.04), and primary brain insult (OR, 2.00; 95% CI, 1.02-4.00; p = 0.047); and no bystander-witnessed seizure onset (OR, 2.49; 95% CI, 1.05-5.59; p = 0.04).
","[{'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Fontaine', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Lemiale', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Resche-Rigon', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Maleka', 'Initials': 'M', 'LastName': 'Schenck', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Chelly', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Geeraerts', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Aicha', 'Initials': 'A', 'LastName': 'Hamdi', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Guitton', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Meziani', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Lefrant', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Megarbane', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Mentec', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Cendrine', 'Initials': 'C', 'LastName': 'Chaffaut', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Cariou', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Legriel', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France. stlegriel@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000010726']
2747,32925337,A Single Prophylactic Dose of Ondansetron Given at Cessation of Postoperative Propofol Sedation Decreases Postoperative Nausea and Vomiting in Cardiac Surgery Patients: A Randomized Controlled Trial.,"BACKGROUND
Postoperative nausea and vomiting (PONV) is a common occurrence after cardiac surgery. However, in contrast to other surgical populations, routine PONV prophylaxis is not a standard of care in cardiac surgery. We hypothesized that routine administration of a single prophylactic dose of ondansetron (4 mg) at the time of stopping postoperative propofol sedation before extubation in the cardiac surgery intensive care unit would decrease the incidence of PONV.
METHODS
With institutional human ethics board approval and written informed consent, we conducted a randomized controlled trial in patients ≥19 years of age with no history of PONV undergoing elective or urgent cardiac surgery procedures requiring cardiopulmonary bypass. The primary outcome was the incidence of PONV in the first 24 hours postextubation, compared by the χ test. Secondary outcomes included the incidence and times to first dose of rescue antiemetic treatment administration, the incidence of headaches, and the incidence of ventricular arrhythmias.
RESULTS
PONV within the first 24 hours postextubation occurred in 33 of 77 patients (43%) in the ondansetron group versus 50 of 82 patients (61%) in the placebo group (relative risk, 0.70 [95% confidence interval {CI}, 0.51-0.95]; absolute risk difference, -18% [95% CI, -33 to -2]; number needed to treat, 5.5 [95% CI, 3.0-58.4]; χ test, P = .022). Kaplan-Meier ""survival"" analysis of the times to first rescue antiemetic treatment administration over 24 hours indicated that patients in the ondansetron group fared better than those in the placebo group (log-rank [Mantel-Cox] test; P = .028). Overall, 32 of 77 patients (42%) in the ondansetron group received rescue antiemetic treatment over the first 24 hours postextubation versus 47 of 82 patients (57%) in the placebo group (relative risk, 0.73 [95% CI, 0.52-1.00]; absolute risk difference, -16% [95% CI, -31 to 1]); P = .047. There were no significant differences between the groups in the incidence of postoperative headache (ondansetron group, 5 of 77 patients [6%] versus placebo group, 4 of 82 patients [5%]; Fisher exact test; P = .740) or ventricular arrhythmias (ondansetron group, 2 of 77 patients [3%] versus placebo group, 4 of 82 patients [5%]; P = .68).
CONCLUSIONS
These findings support the routine administration of ondansetron prophylaxis at the time of discontinuation of postoperative propofol sedation before extubation in patients following cardiac surgery. Further research is warranted to optimize PONV prophylaxis in cardiac surgery patients.",2020,"There were no significant differences between the groups in the incidence of postoperative headache (ondansetron group, 5 of 77 patients [6%] versus placebo group, 4 of 82 patients [5%];","['cardiac surgery patients', 'patients ≥19 years of age with no history of PONV undergoing elective or urgent cardiac surgery procedures requiring cardiopulmonary bypass', 'Cardiac Surgery Patients', 'patients following cardiac surgery']","['ondansetron prophylaxis', 'placebo', 'Ondansetron', 'ondansetron', 'Propofol Sedation']","['incidence of postoperative headache', 'PONV', 'Postoperative Nausea and Vomiting', 'incidence and times to first dose of rescue antiemetic treatment administration, the incidence of headaches, and the incidence of ventricular arrhythmias', 'rescue antiemetic treatment', 'incidence of PONV in the first 24 hours postextubation', 'ventricular arrhythmias']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]",,0.566015,"There were no significant differences between the groups in the incidence of postoperative headache (ondansetron group, 5 of 77 patients [6%] versus placebo group, 4 of 82 patients [5%];","[{'ForeName': 'Erica H Z', 'Initials': 'EHZ', 'LastName': 'Wang', 'Affiliation': ""From the Pharmacy Department, St Paul's Hospital, Providence Health Care, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sunderland', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Nicola Y', 'Initials': 'NY', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesia, St Paul's Hospital, Providence Health Care, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Navraj S', 'Initials': 'NS', 'LastName': 'Chima', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Cynthia H', 'Initials': 'CH', 'LastName': 'Yarnold', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Stephan K W', 'Initials': 'SKW', 'LastName': 'Schwarz', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Coley', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004730']
2748,32925342,"The Effects of a Shoulder Roll During Laryngoscopy in Infants: A Randomized, Single-Blinded, Crossover Study.","BACKGROUND
The use of a shoulder roll to view the glottic opening during direct laryngoscopy in infants has been recommended but is not evidence based.
METHODS
Twenty infants with normal airways, <6 months of age undergoing elective surgery under general anesthesia were randomized to undergo direct laryngoscopy first with a 2-inch vertical shoulder roll and then without, or vice versa. The primary outcome was the difference in the vertical distance between the angle of the laryngoscopist's eye and the operating room table in the 2 positions. Also, the views of the glottic opening in both positions were recorded for each infant and analyzed by a blinded investigator using the percent of glottic opening (POGO).
RESULTS
Twenty infants completed the study without complications. The vertical distance did not differ significantly whether the shoulder roll was placed first or second, and there was no evidence of a differential carryover effect in the crossover design (P = .268). The main effect of the shoulder roll on the mean (95% confidence interval [CI]) vertical distances without 47.8 cm (43.5-52.1) and with the shoulder roll 37.2 cm (33.3-41) yielded a mean (95% CI) vertical difference of 10.6 cm (9.3-11.79; P = .0001). The median (interquartile range [IQR]) POGO scores without 100 [86.2, 100] and with the shoulder roll 97.5 [80, 100] did not differ (median difference [95% CI]: 0 [-20 to 0]; P = .39).
CONCLUSIONS
A 2-inch shoulder roll lowers the line of sight of the glottic opening compared with no shoulder roll, without affecting the view of the glottic opening during laryngoscopy in infants.",2020,"The vertical distance did not differ significantly whether the shoulder roll was placed first or second, and there was no evidence of a differential carryover effect in the crossover design (P = .268).","['Twenty infants with normal airways, <6 months of age undergoing elective surgery under general anesthesia', 'Twenty infants completed the study without complications', 'Infants']","['direct laryngoscopy first with a 2-inch vertical shoulder roll and then without, or vice versa', 'Shoulder Roll']","['median (interquartile range [IQR]) POGO scores', ""vertical distance between the angle of the laryngoscopist's eye and the operating room table in the 2 positions"", 'vertical distance']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy'}, {'cui': 'C0450394', 'cui_str': '2 inch'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",20.0,0.278582,"The vertical distance did not differ significantly whether the shoulder roll was placed first or second, and there was no evidence of a differential carryover effect in the crossover design (P = .268).","[{'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Alfahel', 'Affiliation': ""From the Department of Anesthesia, John R. Oishei Children's Hospital, Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York.""}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Gopinath', 'Affiliation': ""From the Department of Anesthesia, John R. Oishei Children's Hospital, Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York.""}, {'ForeName': 'Kristopher L', 'Initials': 'KL', 'LastName': 'Arheart', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of Miami School of Medicine, Miami, Florida.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Gensler', 'Affiliation': ""From the Department of Anesthesia, John R. Oishei Children's Hospital, Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York.""}, {'ForeName': 'Jerrold', 'Initials': 'J', 'LastName': 'Lerman', 'Affiliation': ""From the Department of Anesthesia, John R. Oishei Children's Hospital, Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York.""}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004802']
2749,32925344,ADAPT-2: A Randomized Clinical Trial to Reduce Intraoperative EEG Suppression in Older Surgical Patients Undergoing Major Noncardiac Surgery.,"BACKGROUND
Recent limited evidence suggests that the use of a processed electroencephalographic (EEG) monitor to guide anesthetic management may influence postoperative cognitive outcomes; however, the mechanism is unclear.
METHODS
This exploratory, single-center, randomized clinical trial included patients who were ≥65 years of age undergoing elective noncardiac surgery. The study aimed to determine whether monitoring the brain using a processed EEG monitor reduced EEG suppression and subsequent postoperative delirium. The interventional group received processed EEG-guided anesthetic management to keep the Patient State Index (PSI) above 35 computed by the SEDline Brain Function Monitor (Masimo, Inc, Irvine, CA), while the standard care group was also monitored, but the EEG data were blinded from the clinicians. The primary outcome was intraoperative EEG suppression. A secondary outcome was incident postoperative delirium during the first 3 days after surgery.
RESULTS
All outcomes were analyzed using the intention-to-treat paradigm. Two hundred and four patients with a mean age of 72 ± 5 years were studied. Minutes of EEG suppression adjusted by the length of surgery was found to be less for the interventional group than the standard care group (median [interquartile range], 1.4% [5.0%] and 2.5% [10.4%]; Hodges-Lehmann estimated median difference [95% confidence interval {CI}] of -0.8% [-2.1 to -0.000009]). The effect of the intervention on EEG suppression differed for those with and without preoperative cognitive impairment (interaction P = .01), with the estimated incidence rate ratio (95% CI) of 0.39 (0.33-0.44) for those with preoperative cognitive impairment and 0.48 (0.44-0.51) for those without preoperative cognitive impairment. The incidence of delirium was not found to be different between the interventional (17%) and the standard care groups (20%), risk ratio = 0.85 (95% CI, 0.47-1.5).
CONCLUSIONS
The use of processed EEG to maintain the PSI >35 was associated with less time spent in intraoperative EEG suppression. Preoperative cognitive impairment was associated with a greater percent of surgical time spent in EEG suppression. A larger prospective cohort study to include more cognitively vulnerable patients is necessary to show whether an intervention to reduce EEG suppression is efficacious in reducing postoperative delirium.",2020,"Minutes of EEG suppression adjusted by the length of surgery was found to be less for the interventional group than the standard care group (median [interquartile range], 1.4% [5.0%] and 2.5% [10.4%]; Hodges-Lehmann estimated median difference [95% confidence interval {CI}] of -0.8% [-2.1 to -0.000009]).","['Two hundred and four patients with a mean age of 72 ± 5 years were studied', 'Older Surgical Patients Undergoing Major Noncardiac Surgery', 'patients who were ≥65 years of age undergoing elective noncardiac surgery', 'cognitively vulnerable patients']","['ADAPT-2', 'Intraoperative EEG Suppression', 'processed EEG-guided anesthetic management to keep the Patient State Index (PSI) above 35 computed by the SEDline Brain Function Monitor (Masimo, Inc, Irvine, CA']","['EEG suppression and subsequent postoperative delirium', 'incidence rate ratio', 'Minutes of EEG suppression adjusted by the length of surgery', 'incident postoperative delirium', 'Preoperative cognitive impairment', 'intraoperative EEG suppression', 'incidence of delirium', 'EEG suppression']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]",204.0,0.158331,"Minutes of EEG suppression adjusted by the length of surgery was found to be less for the interventional group than the standard care group (median [interquartile range], 1.4% [5.0%] and 2.5% [10.4%]; Hodges-Lehmann estimated median difference [95% confidence interval {CI}] of -0.8% [-2.1 to -0.000009]).","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Tang', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Zhongnan', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Center for Gerontology and Department of Statistics, Virginia Tech, Blacksburg, VA.'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Sands', 'Affiliation': 'Center for Gerontology and Department of Statistics, Virginia Tech, Blacksburg, VA.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Pleasants', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sanam', 'Initials': 'S', 'LastName': 'Tabatabai', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Yili', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Center for Gerontology and Department of Statistics, Virginia Tech, Blacksburg, VA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Leung', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004713']
2750,32876697,Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial.,"Importance
Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited.
Objective
To determine whether hydrocortisone improves outcome for patients with severe COVID-19.
Design, Setting, and Participants
An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020.
Interventions
The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108).
Main Outcomes and Measures
The primary end point was organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned -1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%).
Results
After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n = 137), shock-dependent (n = 146), and no (n = 101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis. The mean age for the 3 groups ranged between 59.5 and 60.4 years; most patients were male (range, 70.6%-71.5%); mean body mass index ranged between 29.7 and 30.9; and patients receiving mechanical ventilation ranged between 50.0% and 63.5%. For the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively, the median organ support-free days were 0 (IQR, -1 to 15), 0 (IQR, -1 to 13), and 0 (-1 to 11) days (composed of 30%, 26%, and 33% mortality rates and 11.5, 9.5, and 6 median organ support-free days among survivors). The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone. Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1%) patients in the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively.
Conclusions and Relevance
Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support-free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions.
Trial Registration
ClinicalTrials.gov Identifier: NCT02735707.",2020,"The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone.","['Patients With Severe COVID-19', 'patients with severe COVID-19', 'Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries', '19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n\u2009=\u2009137), shock-dependent (n\u2009=\u2009146), and no (n\u2009=\u2009101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis']","['no hydrocortisone', 'hydrocortisone', 'Hydrocortisone', 'intravenous hydrocortisone']","['mechanical ventilation', 'mean body mass index', 'Mortality and Organ Support', 'posterior probability of an odds ratio greater', 'median adjusted odds ratio and bayesian probability of superiority', 'mortality rates', 'Serious adverse events', 'organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",614.0,0.46384,"The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone.","[{'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'The Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lennie', 'Initials': 'L', 'LastName': 'Derde', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Al-Beidh', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care Medicine, Department of Surgery and Cancer, Imperial College London and Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Djillali', 'Initials': 'D', 'LastName': 'Annane', 'Affiliation': 'Intensive Care Unit, Raymond Poincaré Hospital (AP-HP), Paris, France.'}, {'ForeName': 'Yaseen', 'Initials': 'Y', 'LastName': 'Arabi', 'Affiliation': 'Intensive Care Department, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Beane', 'Affiliation': 'Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'van Bentum-Puijk', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Bhimani', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Bradbury', 'Affiliation': 'Bristol Royal Informatory, Bristol, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Brunkhorst', 'Affiliation': 'Center for Clinical Studies and Center for Sepsis Control and Care (CSCC), Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Buxton', 'Affiliation': 'Global Coalition for Adaptive Research, San Francisco, California.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Buzgau', 'Affiliation': 'Helix, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'Infection Prevention and Healthcare Epidemiology Unit, Alfred Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Menno', 'Initials': 'M', 'LastName': 'de Jong', 'Affiliation': 'Department of Medical Microbiology, Amsterdam University Medical Center, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Detry', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Estcourt', 'Affiliation': 'NHS Blood and Transplant, Bristol, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fitzgerald', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Goossens', 'Affiliation': 'Department of Microbiology, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rashan', 'Initials': 'R', 'LastName': 'Haniffa', 'Affiliation': 'Network for Improving Critical Care Systems and Training, Colombo, Sri Lanka.'}, {'ForeName': 'Alisa M', 'Initials': 'AM', 'LastName': 'Higgins', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Horvat', 'Affiliation': 'The Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Sebastiaan J', 'Initials': 'SJ', 'LastName': 'Hullegie', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kruger', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Lawler', 'Affiliation': 'Cardiac Intensive Care Unit, Peter Munk Cardiac Centre, University Health Network, Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Linstrum', 'Affiliation': 'The Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'School of Medicine and Pharmacology, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lorenzi', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'McAuley', 'Affiliation': ""Centre for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McGlothin', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'McVerry', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Montgomery', 'Affiliation': 'The Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'University of British Columbia School of Medicine, Vancouver, Canada.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Nichol', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parke', 'Affiliation': 'Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rowan', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sanil', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Santos', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Seymour', 'Affiliation': 'The Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van de Veerdonk', 'Affiliation': 'Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'Southside Clinical Unit, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'Department of Medicine, Critical Care and Hematology/Medical Oncology, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Lewis', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Webb', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care Medicine, Department of Surgery and Cancer, Imperial College London and Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Al-Beidh', 'Affiliation': ''}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Angus', 'Affiliation': ''}, {'ForeName': 'Djillali', 'Initials': 'D', 'LastName': 'Annane', 'Affiliation': ''}, {'ForeName': 'Yaseen', 'Initials': 'Y', 'LastName': 'Arabi', 'Affiliation': ''}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'van Bentum-Puijk', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berry', 'Affiliation': ''}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Beane', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Bhimani', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bonten', 'Affiliation': ''}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Bradbury', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Brunkhorst', 'Affiliation': ''}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Buxton', 'Affiliation': ''}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Menno', 'Initials': 'M', 'LastName': 'De Jong', 'Affiliation': ''}, {'ForeName': 'Lennie', 'Initials': 'L', 'LastName': 'Derde', 'Affiliation': ''}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Estcourt', 'Affiliation': ''}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Goossens', 'Affiliation': ''}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gordon', 'Affiliation': ''}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'Rashan', 'Initials': 'R', 'LastName': 'Haniffa', 'Affiliation': ''}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lawler', 'Affiliation': ''}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': ''}, {'ForeName': 'Colin', 'Initials': '', 'LastName': 'McArthur', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'McAuley', 'Affiliation': ''}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': ''}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'McVerry', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Montgomery', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mouncey', 'Affiliation': ''}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': ''}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Nichol', 'Affiliation': ''}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parke', 'Affiliation': ''}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rowan', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Seymour', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van de Veerdonk', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Webb', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': ''}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Forbes', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gattas', 'Affiliation': ''}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Heritier', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Higgins', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kruger', 'Affiliation': ''}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Peake', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Presneill', 'Affiliation': ''}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Seppelt', 'Affiliation': ''}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Trapani', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Bagshaw', 'Affiliation': ''}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Daneman', 'Affiliation': ''}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Ferguson', 'Affiliation': ''}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Misak', 'Affiliation': ''}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Santos', 'Affiliation': ''}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Hullegie', 'Affiliation': ''}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Pletz', 'Affiliation': ''}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Rohde', 'Affiliation': ''}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Rowan', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Alexander', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Basile', 'Affiliation': ''}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Girard', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Horvat', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Linstrum', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Vates', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fowler', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'McGloughlin', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Morpeth', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Paterson', 'Affiliation': ''}, {'ForeName': 'Bala', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': ''}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Uyeki', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Baillie', 'Affiliation': ''}, {'ForeName': 'Eamon', 'Initials': 'E', 'LastName': 'Duffy', 'Affiliation': ''}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Fowler', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hills', 'Affiliation': ''}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Orr', 'Affiliation': ''}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Patanwala', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Tong', 'Affiliation': ''}, {'ForeName': 'Mihai', 'Initials': 'M', 'LastName': 'Netea', 'Affiliation': ''}, {'ForeName': 'Shilesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': ''}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Fergusson', 'Affiliation': ''}, {'ForeName': 'Ewan', 'Initials': 'E', 'LastName': 'Goligher', 'Affiliation': ''}, {'ForeName': 'Ghady', 'Initials': 'G', 'LastName': 'Haidar', 'Affiliation': ''}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Hunt', 'Affiliation': ''}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Laffan', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lawless', 'Affiliation': ''}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Lother', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McCallum', 'Affiliation': ''}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Middeldopr', 'Affiliation': ''}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'McQuilten', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pasi', 'Affiliation': ''}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Schutgens', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Stanworth', 'Affiliation': ''}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Turgeon', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Weissman', 'Affiliation': ''}, {'ForeName': 'Neill', 'Initials': 'N', 'LastName': 'Adhikari', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Anstey', 'Affiliation': ''}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Brant', 'Affiliation': ''}, {'ForeName': 'Angelique', 'Initials': 'A', 'LastName': 'de Man', 'Affiliation': ''}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Lamonagne', 'Affiliation': ''}, {'ForeName': 'Marie-Helene', 'Initials': 'MH', 'LastName': 'Masse', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Udy', 'Affiliation': ''}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Arnold', 'Affiliation': ''}, {'ForeName': 'Phillipe', 'Initials': 'P', 'LastName': 'Begin', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Charlewood', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chasse', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Coyne', 'Affiliation': ''}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Cooper', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Daly', 'Affiliation': ''}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Gosbell', 'Affiliation': ''}, {'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Harvala-Simmonds', 'Affiliation': ''}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Hills', 'Affiliation': ''}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'MacLennan', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Menon', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McDyer', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Pridee', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Roberts', 'Affiliation': ''}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Shankar-Hari', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Tinmouth', 'Affiliation': ''}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'Triulzi', 'Affiliation': ''}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Wood', 'Affiliation': ''}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Calfee', 'Affiliation': ''}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'O’Kane', 'Affiliation': ''}, {'ForeName': 'Murali', 'Initials': 'M', 'LastName': 'Shyamsundar', 'Affiliation': ''}, {'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Sinha', 'Affiliation': ''}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': ''}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Hodgson', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Laffey', 'Affiliation': ''}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'McAuley', 'Affiliation': ''}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Orford', 'Affiliation': ''}, {'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Neto', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Detry', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fitzgerald', 'Affiliation': ''}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McGlothlin', 'Affiliation': ''}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sanil', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': ''}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Berry', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lorenzi', 'Affiliation': ''}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Zammit', 'Affiliation': ''}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'van Bentum Puijk', 'Affiliation': ''}, {'ForeName': 'Wietske', 'Initials': 'W', 'LastName': 'Bouwman', 'Affiliation': ''}, {'ForeName': 'Yara', 'Initials': 'Y', 'LastName': 'Mangindaan', 'Affiliation': ''}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Parker', 'Affiliation': ''}, {'ForeName': 'Svenja', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': ''}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Rietveld', 'Affiliation': ''}, {'ForeName': 'Kik', 'Initials': 'K', 'LastName': 'Raymakers', 'Affiliation': ''}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Ganpat', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Brillinger', 'Affiliation': ''}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Markgraf', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ainscough', 'Affiliation': ''}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Brickell', 'Affiliation': ''}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Anjum', 'Affiliation': ''}, {'ForeName': 'Janis-Best', 'Initials': 'JB', 'LastName': 'Lane', 'Affiliation': ''}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Richards-Belle', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Saull', 'Affiliation': ''}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': ''}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Bion', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Connor', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Manax', 'Affiliation': ''}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'van der Poll', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Reynolds', 'Affiliation': ''}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'van Beurden', 'Affiliation': ''}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Effelaar', 'Affiliation': ''}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Schotsman', 'Affiliation': ''}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Boyd', 'Affiliation': ''}, {'ForeName': 'Cain', 'Initials': 'C', 'LastName': 'Harland', 'Affiliation': ''}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Shearer', 'Affiliation': ''}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'Wren', 'Affiliation': ''}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Clermont', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Garrard', 'Affiliation': ''}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Kalchthaler', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ricketts', 'Affiliation': ''}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Malakoutis', 'Affiliation': ''}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Marroquin', 'Affiliation': ''}, {'ForeName': 'Edvin', 'Initials': 'E', 'LastName': 'Music', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Quinn', 'Affiliation': ''}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Cate', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Pearson', 'Affiliation': ''}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hanson', 'Affiliation': ''}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Jackson', 'Affiliation': ''}, {'ForeName': 'Adeeba', 'Initials': 'A', 'LastName': 'Asghar', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dyas', 'Affiliation': ''}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Sutu', 'Affiliation': ''}, {'ForeName': 'Sheenagh', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Williamson', 'Affiliation': ''}, {'ForeName': 'Nhlanhla', 'Initials': 'N', 'LastName': 'Mguni', 'Affiliation': ''}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Potter', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Porter', 'Affiliation': ''}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Goodwin', 'Affiliation': ''}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Rook', 'Affiliation': ''}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Harrison', 'Affiliation': ''}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Kaatje', 'Initials': 'K', 'LastName': 'Lomme', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sheffield', 'Affiliation': ''}, {'ForeName': 'Willian', 'Initials': 'W', 'LastName': 'van’t Hoff', 'Affiliation': ''}, {'ForeName': 'Phobe', 'Initials': 'P', 'LastName': 'McCracken', 'Affiliation': ''}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Board', 'Affiliation': ''}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Mart', 'Affiliation': ''}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Knott', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Boschert', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Affleck', 'Affiliation': ''}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Ramanan', 'Affiliation': ''}, {'ForeName': 'Ramsy', 'Initials': 'R', 'LastName': 'D’Souza', 'Affiliation': ''}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Pateman', 'Affiliation': ''}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Shakih', 'Affiliation': ''}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Cheung', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kol', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Wagh', 'Affiliation': ''}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Simpson', 'Affiliation': ''}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Duke', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Cartner', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hunter', 'Affiliation': ''}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Laver', 'Affiliation': ''}, {'ForeName': 'Tapaswi', 'Initials': 'T', 'LastName': 'Shrestha', 'Affiliation': ''}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Regli', 'Affiliation': ''}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Pellicano', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McCullough', 'Affiliation': ''}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Tallott', 'Affiliation': ''}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Rakshit', 'Initials': 'R', 'LastName': 'Panwar', 'Affiliation': ''}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Brinkerhoff', 'Affiliation': ''}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Koppen', 'Affiliation': ''}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Cazzola', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Brain', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mineall', 'Affiliation': ''}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fischer', 'Affiliation': ''}, {'ForeName': 'Vishwanath', 'Initials': 'V', 'LastName': 'Biradar', 'Affiliation': ''}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Soar', 'Affiliation': ''}, {'ForeName': 'Hayden', 'Initials': 'H', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Estensen', 'Affiliation': ''}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': ''}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cooper', 'Affiliation': ''}, {'ForeName': 'Monash', 'Initials': 'M', 'LastName': 'Health', 'Affiliation': ''}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': ''}, {'ForeName': 'Wisam', 'Initials': 'W', 'LastName': 'Al-Bassam', 'Affiliation': ''}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Hulley', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Whitehead', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lowrey', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gresha', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Walsham', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Meyer', 'Affiliation': ''}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Harward', 'Affiliation': ''}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Venz', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kurenda', 'Affiliation': ''}, {'ForeName': 'Kirsy', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Garcia', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Barge', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Byrne', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Byrne', 'Affiliation': ''}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Driscoll', 'Affiliation': ''}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Fortune', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Janin', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Yarad', 'Affiliation': ''}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Hammond', 'Affiliation': ''}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Bass', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ashelford', 'Affiliation': ''}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Waterson', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Wedd', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McNamara', 'Affiliation': ''}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Buhr', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Coles', 'Affiliation': ''}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Schweikert', 'Affiliation': ''}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Wibrow', 'Affiliation': ''}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Rauniyar', 'Affiliation': ''}, {'ForeName': 'Erina', 'Initials': 'E', 'LastName': 'Myers', 'Affiliation': ''}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Fysh', 'Affiliation': ''}, {'ForeName': 'Ashlish', 'Initials': 'A', 'LastName': 'Dawda', 'Affiliation': ''}, {'ForeName': 'Bhaumik', 'Initials': 'B', 'LastName': 'Mevavala', 'Affiliation': ''}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': ''}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Ferrier', 'Affiliation': ''}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Nair', 'Affiliation': ''}, {'ForeName': 'Hergen', 'Initials': 'H', 'LastName': 'Buscher', 'Affiliation': ''}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Reynolds', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Santamaria', 'Affiliation': ''}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Barbazza', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Homes', 'Affiliation': ''}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': ''}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Brailsford', 'Affiliation': ''}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Forbes', 'Affiliation': ''}, {'ForeName': 'Teena', 'Initials': 'T', 'LastName': 'Maguire', 'Affiliation': ''}, {'ForeName': 'Vasanth', 'Initials': 'V', 'LastName': 'Mariappa', 'Affiliation': ''}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Simpson', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Maiden', 'Affiliation': ''}, {'ForeName': 'Allsion', 'Initials': 'A', 'LastName': 'Bone', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Horton', 'Affiliation': ''}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Salerno', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sterba', 'Affiliation': ''}, {'ForeName': 'Wenli', 'Initials': 'W', 'LastName': 'Geng', 'Affiliation': ''}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Depuydt', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'De Waele', 'Affiliation': ''}, {'ForeName': 'Liesbet', 'Initials': 'L', 'LastName': 'De Bus', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Fierens', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Bracke', 'Affiliation': ''}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Reeve', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Dechert', 'Affiliation': ''}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Chassé', 'Affiliation': ''}, {'ForeName': 'François Martin', 'Initials': 'FM', 'LastName': 'Carrier', 'Affiliation': ''}, {'ForeName': 'Dounia', 'Initials': 'D', 'LastName': 'Boumahni', 'Affiliation': ''}, {'ForeName': 'Fatna', 'Initials': 'F', 'LastName': 'Benettaib', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghamraoui', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bellemare', 'Affiliation': ''}, {'ForeName': 'Ève', 'Initials': 'È', 'LastName': 'Cloutier', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Francoeur', 'Affiliation': ''}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': ''}, {'ForeName': 'Frédérick', 'Initials': 'F', 'LastName': 'D’Aragon', 'Affiliation': ''}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Carbonneau', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Leblond', 'Affiliation': ''}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Vazquez-Grande', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marten', 'Affiliation': ''}, {'ForeName': 'Maggie', 'Initials': '', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Albert', 'Affiliation': ''}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Serri', 'Affiliation': ''}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Cavayas', 'Affiliation': ''}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Duplaix', 'Affiliation': ''}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Rochwerg', 'Affiliation': ''}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Karachi', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Oczkowski', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Centofanti', 'Affiliation': ''}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Millen', 'Affiliation': ''}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Duan', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Tsang', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Patterson', 'Affiliation': ''}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'English', 'Affiliation': ''}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Watpool', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Porteous', 'Affiliation': ''}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Miezitis', 'Affiliation': ''}, {'ForeName': 'Lauralyn', 'Initials': 'L', 'LastName': 'McIntyre', 'Affiliation': ''}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Brochard', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Burns', 'Affiliation': ''}, {'ForeName': 'Gyan', 'Initials': 'G', 'LastName': 'Sandhu', 'Affiliation': ''}, {'ForeName': 'Imrana', 'Initials': 'I', 'LastName': 'Khalid', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Binnie', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Powell', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'McMillan', 'Affiliation': ''}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Luk', 'Affiliation': ''}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Aref', 'Affiliation': ''}, {'ForeName': 'Zdravko', 'Initials': 'Z', 'LastName': 'Andric', 'Affiliation': ''}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Cviljevic', 'Affiliation': ''}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Đimoti', 'Affiliation': ''}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Zapalac', 'Affiliation': ''}, {'ForeName': 'Gordan', 'Initials': 'G', 'LastName': 'Mirković', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Baršić', 'Affiliation': ''}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Kutleša', 'Affiliation': ''}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kotarski', 'Affiliation': ''}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Vujaklija Brajković', 'Affiliation': ''}, {'ForeName': 'Jakša', 'Initials': 'J', 'LastName': 'Babel', 'Affiliation': ''}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Sever', 'Affiliation': ''}, {'ForeName': 'Lidija', 'Initials': 'L', 'LastName': 'Dragija', 'Affiliation': ''}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Kušan', 'Affiliation': ''}, {'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Vaara', 'Affiliation': ''}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Pettilä', 'Affiliation': ''}, {'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Heinonen', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kuitunen', 'Affiliation': ''}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Karlsson', 'Affiliation': ''}, {'ForeName': 'Annukka', 'Initials': 'A', 'LastName': 'Vahtera', 'Affiliation': ''}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Kiiski', 'Affiliation': ''}, {'ForeName': 'Sanna', 'Initials': 'S', 'LastName': 'Ristimäki', 'Affiliation': ''}, {'ForeName': 'Amine', 'Initials': 'A', 'LastName': 'Azaiz', 'Affiliation': ''}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Charron', 'Affiliation': ''}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Godement', 'Affiliation': ''}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Geri', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Vieillard-Baron', 'Affiliation': ''}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Pourcine', 'Affiliation': ''}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Monchi', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Luis', 'Affiliation': ''}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Mercier', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sagnier', 'Affiliation': ''}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Verrier', 'Affiliation': ''}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Caplin', 'Affiliation': ''}, {'ForeName': 'Shidasp', 'Initials': 'S', 'LastName': 'Siami', 'Affiliation': ''}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Aparicio', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Vautier', 'Affiliation': ''}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Jeblaoui', 'Affiliation': ''}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Fartoukh', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Courtin', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Labbe', 'Affiliation': ''}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Leparco', 'Affiliation': ''}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Muller', 'Affiliation': ''}, {'ForeName': 'Mai-Anh', 'Initials': 'MA', 'LastName': 'Nay', 'Affiliation': ''}, {'ForeName': 'Toufik', 'Initials': 'T', 'LastName': 'Kamel', 'Affiliation': ''}, {'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Benzekri', 'Affiliation': ''}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Jacquier', 'Affiliation': ''}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Mercier', 'Affiliation': ''}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Chartier', 'Affiliation': ''}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Salmon', 'Affiliation': ''}, {'ForeName': 'PierreFrançois', 'Initials': 'P', 'LastName': 'Dequin', 'Affiliation': ''}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Schneider', 'Affiliation': ''}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Morel', 'Affiliation': ''}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'L’Hotellier', 'Affiliation': ''}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Badie', 'Affiliation': ''}, {'ForeName': 'Fernando Daniel', 'Initials': 'FD', 'LastName': 'Berdaguer', 'Affiliation': ''}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Malfroy', 'Affiliation': ''}, {'ForeName': 'Chaouki', 'Initials': 'C', 'LastName': 'Mezher', 'Affiliation': ''}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Bourgoin', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Megarbane', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': '', 'LastName': 'Voicu', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Deye', 'Affiliation': ''}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Malissin', 'Affiliation': ''}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Sutterlin', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Guitton', 'Affiliation': ''}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Darreau', 'Affiliation': ''}, {'ForeName': 'Mickaël', 'Initials': 'M', 'LastName': 'Landais', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Chudeau', 'Affiliation': ''}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Robert', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Moine', 'Affiliation': ''}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Heming', 'Affiliation': ''}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Maxime', 'Affiliation': ''}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Bossard', 'Affiliation': ''}, {'ForeName': 'Tiphaine Barbarin', 'Initials': 'TB', 'LastName': 'Nicholier', 'Affiliation': ''}, {'ForeName': 'Gwenhael', 'Initials': 'G', 'LastName': 'Colin', 'Affiliation': ''}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Zinzoni', 'Affiliation': ''}, {'ForeName': 'Natacham', 'Initials': 'N', 'LastName': 'Maquigneau', 'Affiliation': ''}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Finn', 'Affiliation': ''}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Kreß', 'Affiliation': ''}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Hoff', 'Affiliation': ''}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Friedrich Hinrichs', 'Affiliation': ''}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Nee', 'Affiliation': ''}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Pletz', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hagel', 'Affiliation': ''}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Ankert', 'Affiliation': ''}, {'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'Kolanos', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Bloos', 'Affiliation': ''}, {'ForeName': 'Sirak', 'Initials': 'S', 'LastName': 'Petros', 'Affiliation': ''}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Pasieka', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kunz', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Appelt', 'Affiliation': ''}, {'ForeName': 'Bianka', 'Initials': 'B', 'LastName': 'Schütze', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kluge', 'Affiliation': ''}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Nierhaus', 'Affiliation': ''}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Jarczak', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Roedl', 'Affiliation': ''}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Weismann', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Frey', 'Affiliation': ''}, {'ForeName': 'Vivantes', 'Initials': 'V', 'LastName': 'Klinikum Neukölln', 'Affiliation': ''}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Reill', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Distler', 'Affiliation': ''}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Maselli', 'Affiliation': ''}, {'ForeName': 'János', 'Initials': 'J', 'LastName': 'Bélteczki', 'Affiliation': ''}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Magyar', 'Affiliation': ''}, {'ForeName': 'Ágnes', 'Initials': 'Á', 'LastName': 'Fazekas', 'Affiliation': ''}, {'ForeName': 'Sándor', 'Initials': 'S', 'LastName': 'Kovács', 'Affiliation': ''}, {'ForeName': 'Viktória', 'Initials': 'V', 'LastName': 'Szőke', 'Affiliation': ''}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Szigligeti', 'Affiliation': ''}, {'ForeName': 'János', 'Initials': 'J', 'LastName': 'Leszkoven', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Breen', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Frohlich', 'Affiliation': ''}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Whelan', 'Affiliation': ''}, {'ForeName': 'Bairbre', 'Initials': 'B', 'LastName': 'McNicholas', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Scully', 'Affiliation': ''}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Maeve', 'Initials': 'M', 'LastName': 'Kernan', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Doran', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'O’Dywer', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Smyth', 'Affiliation': ''}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hayes', 'Affiliation': ''}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Hoiting', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Peters', 'Affiliation': ''}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Rengers', 'Affiliation': ''}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Evers', 'Affiliation': ''}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Prinssen', 'Affiliation': ''}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Bosch Ziekenhuis', 'Affiliation': ''}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Simons', 'Affiliation': ''}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Rozendaal', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Polderman', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'de Jager', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moviat', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Paling', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Salet', 'Affiliation': ''}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Rademaker', 'Affiliation': ''}, {'ForeName': 'Anna Linda', 'Initials': 'AL', 'LastName': 'Peters', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'de Jonge', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wigbers', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Guilder', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Butler', 'Affiliation': ''}, {'ForeName': 'Keri-Anne', 'Initials': 'KA', 'LastName': 'Cowdrey', 'Affiliation': ''}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Newby', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Simmonds', 'Affiliation': ''}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'McConnochie', 'Affiliation': ''}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Ritzema Carter', 'Affiliation': ''}, {'ForeName': 'Seton', 'Initials': 'S', 'LastName': 'Henderson', 'Affiliation': ''}, {'ForeName': 'Kym', 'Initials': 'K', 'LastName': 'Van Der Heyden', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mehrtens', 'Affiliation': ''}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kazemi', 'Affiliation': ''}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Lai', 'Affiliation': ''}, {'ForeName': 'Dinu', 'Initials': 'D', 'LastName': 'Girijadevi', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Everitt', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Russell', 'Affiliation': ''}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hacking', 'Affiliation': ''}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Buehner', 'Affiliation': ''}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Browne', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Grimwade', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Goodson', 'Affiliation': ''}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Keet', 'Affiliation': ''}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Callender', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Martynoga', 'Affiliation': ''}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Trask', 'Affiliation': ''}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Butler', 'Affiliation': ''}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Schischka', 'Affiliation': ''}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Eden', 'Initials': 'E', 'LastName': 'Lesona', 'Affiliation': ''}, {'ForeName': 'Shaanti', 'Initials': 'S', 'LastName': 'Olatunji', 'Affiliation': ''}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Robertson', 'Affiliation': ''}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'José', 'Affiliation': ''}, {'ForeName': 'Teodoro', 'Initials': 'T', 'LastName': 'Amaro dos Santos Catorze', 'Affiliation': ''}, {'ForeName': 'Tiago Nuno Alfaro', 'Initials': 'TNA', 'LastName': 'de Lima Pereira', 'Affiliation': ''}, {'ForeName': 'Lucilia Maria', 'Initials': 'LM', 'LastName': 'Neves Pessoa', 'Affiliation': ''}, {'ForeName': 'Ricardo Manuel', 'Initials': 'RM', 'LastName': 'Castro Ferreira', 'Affiliation': ''}, {'ForeName': 'Joana Margarida', 'Initials': 'JM', 'LastName': 'Pereira Sousa Bastos', 'Affiliation': ''}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Aysel Florescu', 'Affiliation': ''}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Stanciu', 'Affiliation': ''}, {'ForeName': 'Miahela Florentina', 'Initials': 'MF', 'LastName': 'Zaharia', 'Affiliation': ''}, {'ForeName': 'Alma Gabriela', 'Initials': 'AG', 'LastName': 'Kosa', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Codreanu', 'Affiliation': ''}, {'ForeName': 'Yaseen', 'Initials': 'Y', 'LastName': 'Marabi', 'Affiliation': ''}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Al Qasim', 'Affiliation': ''}, {'ForeName': 'Mohamned', 'Initials': 'M', 'LastName': 'Moneer Hagazy', 'Affiliation': ''}, {'ForeName': 'Lolowa', 'Initials': 'L', 'LastName': 'Al Swaidan', 'Affiliation': ''}, {'ForeName': 'Hatim', 'Initials': 'H', 'LastName': 'Arishi', 'Affiliation': ''}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Muñoz-Bermúdez', 'Affiliation': ''}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Marin-Corral', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Salazar Degracia', 'Affiliation': ''}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Parrilla Gómez', 'Affiliation': ''}, {'ForeName': 'Maria Isabel', 'Initials': 'MI', 'LastName': 'Mateo López', 'Affiliation': ''}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Rodriguez Fernandez', 'Affiliation': ''}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Cárcel Fernández', 'Affiliation': ''}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Carmona Flores', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'León López', 'Affiliation': ''}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'de la Fuente Martos', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Allan', 'Affiliation': ''}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Polgarova', 'Affiliation': ''}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Farahi', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'McWilliam', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hawcutt', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rad', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'O’Malley', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Whitbread', 'Affiliation': ''}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Kelsall', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Wild', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Thrush', 'Affiliation': ''}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wood', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Austin', 'Affiliation': ''}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Donnelly', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Sinéad', 'Initials': 'S', 'LastName': 'O’Kane', 'Affiliation': ''}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': 'McClintock', 'Affiliation': ''}, {'ForeName': 'Majella', 'Initials': 'M', 'LastName': 'Warnock', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Johnston', 'Affiliation': ''}, {'ForeName': 'Linda Jude', 'Initials': 'LJ', 'LastName': 'Gallagher', 'Affiliation': ''}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Mc Goldrick', 'Affiliation': ''}, {'ForeName': 'Moyra', 'Initials': 'M', 'LastName': 'Mc Master', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Strzelecka', 'Affiliation': ''}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Jha', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kalogirou', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ellis', 'Affiliation': ''}, {'ForeName': 'Vinodh', 'Initials': 'V', 'LastName': 'Krishnamurthy', 'Affiliation': ''}, {'ForeName': 'Vashish', 'Initials': 'V', 'LastName': 'Deelchand', 'Affiliation': ''}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Silversides', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McGuigan', 'Affiliation': ''}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Ward', 'Affiliation': ''}, {'ForeName': 'Aisling', 'Initials': 'A', 'LastName': 'O’Neill', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Finn', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Phillips', 'Affiliation': ''}, {'ForeName': 'Dee', 'Initials': 'D', 'LastName': 'Mullan', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Oritz-Ruiz de Gordoa', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Sweet', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Grimmer', 'Affiliation': ''}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Jez', 'Initials': 'J', 'LastName': 'Pinnell', 'Affiliation': ''}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gledhill', 'Affiliation': ''}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Wood', 'Affiliation': ''}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': ''}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Cole', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Antcliffe', 'Affiliation': ''}, {'ForeName': 'Maie', 'Initials': 'M', 'LastName': 'Templeton', 'Affiliation': ''}, {'ForeName': 'Roceld', 'Initials': 'R', 'LastName': 'Rojo', 'Affiliation': ''}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Coghlan', 'Affiliation': ''}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Smee', 'Affiliation': ''}, {'ForeName': 'Euan', 'Initials': 'E', 'LastName': 'Mackay', 'Affiliation': ''}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Cort', 'Affiliation': ''}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Whileman', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Spencer', 'Affiliation': ''}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Spittle', 'Affiliation': ''}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Kasipandian', 'Affiliation': ''}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Allibone', 'Affiliation': ''}, {'ForeName': 'Roman Mary', 'Initials': 'RM', 'LastName': 'Genetu', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ramali', 'Affiliation': ''}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Ghosh', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bamford', 'Affiliation': ''}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'London', 'Affiliation': ''}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Cawley', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Faulkner', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Jeffrey', 'Affiliation': ''}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brewer', 'Affiliation': ''}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Gregory', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Limb', 'Affiliation': ''}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Cowton', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'O’Brien', 'Affiliation': ''}, {'ForeName': 'Nikitas', 'Initials': 'N', 'LastName': 'Nikitas', 'Affiliation': ''}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Wells', 'Affiliation': ''}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Lankester', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pulletz', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Birch', 'Affiliation': ''}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Wiseman', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Horton', 'Affiliation': ''}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Alegria', 'Affiliation': ''}, {'ForeName': 'Salah', 'Initials': 'S', 'LastName': 'Turki', 'Affiliation': ''}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Elsefi', 'Affiliation': ''}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Crisp', 'Affiliation': ''}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Allen', 'Affiliation': ''}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'McCullagh', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Robinson', 'Affiliation': ''}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Hays', 'Affiliation': ''}, {'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'Babio-Galan', 'Affiliation': ''}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Stevenson', 'Affiliation': ''}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Khare', 'Affiliation': ''}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Pinder', 'Affiliation': ''}, {'ForeName': 'Selvin', 'Initials': 'S', 'LastName': 'Selvamoni', 'Affiliation': ''}, {'ForeName': 'Amitha', 'Initials': 'A', 'LastName': 'Gopinath', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pugh', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Menzies', 'Affiliation': ''}, {'ForeName': 'Callum', 'Initials': 'C', 'LastName': 'Mackay', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allan', 'Affiliation': ''}, {'ForeName': 'Gwyneth', 'Initials': 'G', 'LastName': 'Davies', 'Affiliation': ''}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Puxty', 'Affiliation': ''}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'McCue', 'Affiliation': ''}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Cathcart', 'Affiliation': ''}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Hickey', 'Affiliation': ''}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Ireland', 'Affiliation': ''}, {'ForeName': 'Hakeem', 'Initials': 'H', 'LastName': 'Yusuff', 'Affiliation': ''}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Isgro', 'Affiliation': ''}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brightling', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Bourne', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Craner', 'Affiliation': ''}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Watters', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Prout', 'Affiliation': ''}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Davies', 'Affiliation': ''}, {'ForeName': 'Suzannah', 'Initials': 'S', 'LastName': 'Pegler', 'Affiliation': ''}, {'ForeName': 'Lynsey', 'Initials': 'L', 'LastName': 'Kyeremeh', 'Affiliation': ''}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Arbane', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Gomm', 'Affiliation': ''}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Francia', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Brett', 'Affiliation': ''}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Sousa Arias', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Elin Hall', 'Affiliation': ''}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Budd', 'Affiliation': ''}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Small', 'Affiliation': ''}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Birch', 'Affiliation': ''}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Henning', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bonner', 'Affiliation': ''}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Hugill', 'Affiliation': ''}, {'ForeName': 'Emanuel', 'Initials': 'E', 'LastName': 'Cirstea', 'Affiliation': ''}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Wilkinson', 'Affiliation': ''}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Karlikowski', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Sutherland', 'Affiliation': ''}, {'ForeName': 'Elva', 'Initials': 'E', 'LastName': 'Wilhelmsen', 'Affiliation': ''}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Woods', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'North', 'Affiliation': ''}, {'ForeName': 'Dhinesh', 'Initials': 'D', 'LastName': 'Sundaran', 'Affiliation': ''}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Hollos', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Coburn', 'Affiliation': ''}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Turns', 'Affiliation': ''}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Hopkins', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Noble', 'Affiliation': ''}, {'ForeName': 'Maria Theresa', 'Initials': 'MT', 'LastName': 'Depante', 'Affiliation': ''}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Clarey', 'Affiliation': ''}, {'ForeName': 'Shondipon', 'Initials': 'S', 'LastName': 'Laha', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Verlander', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Huckle', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Cooke', 'Affiliation': ''}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gardiner-Hill', 'Affiliation': ''}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Maloney', 'Affiliation': ''}, {'ForeName': 'Hafiz', 'Initials': 'H', 'LastName': 'Qureshi', 'Affiliation': ''}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Flint', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nicholson', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Southin', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Nicholson', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Borgatta', 'Affiliation': ''}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Turner-Bone', 'Affiliation': ''}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Wilding', 'Affiliation': ''}, {'ForeName': 'Loku', 'Initials': 'L', 'LastName': 'Chamara Warnapura', 'Affiliation': ''}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'Agno Sathianathan', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Golden', 'Affiliation': ''}, {'ForeName': 'Ciaran', 'Initials': 'C', 'LastName': 'Hart', 'Affiliation': ''}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Bannard-Smith', 'Affiliation': ''}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Henry', 'Affiliation': ''}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Birchall', 'Affiliation': ''}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Pomeroy', 'Affiliation': ''}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Quayle', 'Affiliation': ''}, {'ForeName': 'Arystarch', 'Initials': 'A', 'LastName': 'Makowski', 'Affiliation': ''}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Misztal', 'Affiliation': ''}, {'ForeName': 'Iram', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': ''}, {'ForeName': 'Thyra', 'Initials': 'T', 'LastName': 'KyereDiabour', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Naiker', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stewart', 'Affiliation': ''}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Mwaura', 'Affiliation': ''}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Mew', 'Affiliation': ''}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Wren', 'Affiliation': ''}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Willams', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Innes', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Doble', 'Affiliation': ''}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Hutter', 'Affiliation': ''}, {'ForeName': 'Charmaine', 'Initials': 'C', 'LastName': 'Shovelton', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Plumb', 'Affiliation': ''}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Szakmany', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Hamlyn', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Hawkins', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Dell', 'Affiliation': ''}, {'ForeName': 'Shameer', 'Initials': 'S', 'LastName': 'Gopal', 'Affiliation': ''}, {'ForeName': 'Saibal', 'Initials': 'S', 'LastName': 'Ganguly', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Smallwood', 'Affiliation': ''}, {'ForeName': 'Nichola', 'Initials': 'N', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Metherell', 'Affiliation': ''}, {'ForeName': 'Juan Martin', 'Initials': 'JM', 'LastName': 'Lazaro', 'Affiliation': ''}, {'ForeName': 'Tabitha', 'Initials': 'T', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Fletcher', 'Affiliation': ''}, {'ForeName': 'Jurgens', 'Initials': 'J', 'LastName': 'Nortje', 'Affiliation': ''}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Fottrell-Gould', 'Affiliation': ''}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Randell', 'Affiliation': ''}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Zaman', 'Affiliation': ''}, {'ForeName': 'Einas', 'Initials': 'E', 'LastName': 'Elmahi', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Mills', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Ryalls', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Bowler', 'Affiliation': ''}, {'ForeName': 'Jas', 'Initials': 'J', 'LastName': 'Sall', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bourne', 'Affiliation': ''}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Borrill', 'Affiliation': ''}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Duncan', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lamb', 'Affiliation': ''}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': ''}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'Jeronimo', 'Initials': 'J', 'LastName': 'Moreno Cuesta', 'Affiliation': ''}, {'ForeName': 'Kugan', 'Initials': 'K', 'LastName': 'Xavier', 'Affiliation': ''}, {'ForeName': 'Dharam', 'Initials': 'D', 'LastName': 'Purohit', 'Affiliation': ''}, {'ForeName': 'Munzir', 'Initials': 'M', 'LastName': 'Elhassan', 'Affiliation': ''}, {'ForeName': 'Dhanalakshmi', 'Initials': 'D', 'LastName': 'Bakthavatsalam', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Rowland', 'Affiliation': ''}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Hutton', 'Affiliation': ''}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Bashyal', 'Affiliation': ''}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Davidson', 'Affiliation': ''}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Hird', 'Affiliation': ''}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Chhablani', 'Affiliation': ''}, {'ForeName': 'Gunjan', 'Initials': 'G', 'LastName': 'Phalod', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kirkby', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Archer', 'Affiliation': ''}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Netherton', 'Affiliation': ''}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Reschreiter', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Camsooksai', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Patch', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Jenkins', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pogson', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': ''}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Daly', 'Affiliation': ''}, {'ForeName': 'Lutece', 'Initials': 'L', 'LastName': 'Brimfield', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Claridge', 'Affiliation': ''}, {'ForeName': 'Dhruv', 'Initials': 'D', 'LastName': 'Parekh', 'Affiliation': ''}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Bergin', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Bates', 'Affiliation': ''}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Dasgin', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McGhee', 'Affiliation': ''}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Sim', 'Affiliation': ''}, {'ForeName': 'Sophie Kennedy', 'Initials': 'SK', 'LastName': 'Hay', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Henderson', 'Affiliation': ''}, {'ForeName': 'Mandeep-Kaur', 'Initials': 'MK', 'LastName': 'Phull', 'Affiliation': ''}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Zaidi', 'Affiliation': ''}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Pogreban', 'Affiliation': ''}, {'ForeName': 'Lace Paulyn', 'Initials': 'LP', 'LastName': 'Rosaroso', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Harvey', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lowe', 'Affiliation': ''}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Meredith', 'Affiliation': ''}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Ryan', 'Affiliation': ''}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Hormis', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Collier', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kimpton', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Oakley', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Rooney', 'Affiliation': ''}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Rodden', 'Affiliation': ''}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hughes', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Thomson', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'McGlynn', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Walden', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Jacques', 'Affiliation': ''}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Coles', 'Affiliation': ''}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Tilney', 'Affiliation': ''}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Vowell', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schuster-Bruce', 'Affiliation': ''}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Pitts', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Miln', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Purandare', 'Affiliation': ''}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vamplew', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Spivey', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bean', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Burt', 'Affiliation': ''}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Day', 'Affiliation': ''}, {'ForeName': 'Charly', 'Initials': 'C', 'LastName': 'Gibson', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gordon', 'Affiliation': ''}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Zitter', 'Affiliation': ''}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Keenan', 'Affiliation': ''}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Shiney', 'Initials': 'S', 'LastName': 'Cherian', 'Affiliation': ''}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Cutler', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Roynon-Reed', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Harrington', 'Affiliation': ''}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Raithatha', 'Affiliation': ''}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Bauchmuller', 'Affiliation': ''}, {'ForeName': 'Norfaizan', 'Initials': 'N', 'LastName': 'Ahmad', 'Affiliation': ''}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Grecu', 'Affiliation': ''}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Trodd', 'Affiliation': ''}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wrey Brown', 'Affiliation': ''}, {'ForeName': 'Ana-Marie', 'Initials': 'AM', 'LastName': 'Arias', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Craven', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hope', 'Affiliation': ''}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Singleton', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Rae', 'Affiliation': ''}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Welters', 'Affiliation': ''}, {'ForeName': 'David Oliver', 'Initials': 'DO', 'LastName': 'Hamilton', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Waugh', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shaw', 'Affiliation': ''}, {'ForeName': 'Zudin', 'Initials': 'Z', 'LastName': 'Puthucheary', 'Affiliation': ''}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Santos', 'Affiliation': ''}, {'ForeName': 'Ruzena', 'Initials': 'R', 'LastName': 'Uddin', 'Affiliation': ''}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Somerville', 'Affiliation': ''}, {'ForeName': 'Kate Colette', 'Initials': 'KC', 'LastName': 'Tatham', 'Affiliation': ''}, {'ForeName': 'Shaman', 'Initials': 'S', 'LastName': 'Jhanji', 'Affiliation': ''}, {'ForeName': 'Ethel', 'Initials': 'E', 'LastName': 'Black', 'Affiliation': ''}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Dela Rosa', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Howle', 'Affiliation': ''}, {'ForeName': 'Redmond', 'Initials': 'R', 'LastName': 'Tully', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Drummond', 'Affiliation': ''}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Dearden', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Philbin', 'Affiliation': ''}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Munt', 'Affiliation': ''}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Vuylsteke', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Saji', 'Initials': 'S', 'LastName': 'Victor', 'Affiliation': ''}, {'ForeName': 'Ramprasad', 'Initials': 'R', 'LastName': 'Matsa', 'Affiliation': ''}, {'ForeName': 'Minerva', 'Initials': 'M', 'LastName': 'Gellamucho', 'Affiliation': ''}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Creagh-Brown', 'Affiliation': ''}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Tooley', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Montague', 'Affiliation': ''}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'De Beaux', 'Affiliation': ''}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Bullman', 'Affiliation': ''}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Kersiake', 'Affiliation': ''}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Demetriou', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mitchard', 'Affiliation': ''}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Ramos', 'Affiliation': ''}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Donnison', 'Affiliation': ''}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Johns', 'Affiliation': ''}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Lehentha', 'Initials': 'L', 'LastName': 'Mattocks', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Salisbury', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dark', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Claxton', 'Affiliation': ''}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McLachlan', 'Affiliation': ''}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Slevin', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hulme', 'Affiliation': ''}, {'ForeName': 'Sibet', 'Initials': 'S', 'LastName': 'Joseph', 'Affiliation': ''}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Kinney', 'Affiliation': ''}, {'ForeName': 'Ho Jan', 'Initials': 'HJ', 'LastName': 'Senya', 'Affiliation': ''}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Oborska', 'Affiliation': ''}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Kayani', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Hadebe', 'Affiliation': ''}, {'ForeName': 'Rajalakshmi', 'Initials': 'R', 'LastName': 'Orath Prabakaran', 'Affiliation': ''}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Nichols', 'Affiliation': ''}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Worner', 'Affiliation': ''}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Faulkner', 'Affiliation': ''}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Gendall', 'Affiliation': ''}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Hayes', 'Affiliation': ''}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Hamilton-Davies', 'Affiliation': ''}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Mfuko', 'Affiliation': ''}, {'ForeName': 'Hakam', 'Initials': 'H', 'LastName': 'Abbass', 'Affiliation': ''}, {'ForeName': 'Vineela', 'Initials': 'V', 'LastName': 'Mandadapu', 'Affiliation': ''}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Leaver', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Forton', 'Affiliation': ''}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Elankumaran', 'Initials': 'E', 'LastName': 'Paramasivam', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Powell', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gould', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Wilby', 'Affiliation': ''}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Howcroft', 'Affiliation': ''}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Banach', 'Affiliation': ''}, {'ForeName': 'Ziortza', 'Initials': 'Z', 'LastName': 'Fernández de Pinedo Artaraz', 'Affiliation': ''}, {'ForeName': 'Leilani', 'Initials': 'L', 'LastName': 'Cabreros', 'Affiliation': ''}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Croft', 'Affiliation': ''}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Holland', 'Affiliation': ''}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Pereira', 'Affiliation': ''}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Zaki', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jackson', 'Affiliation': ''}, {'ForeName': 'Hywel', 'Initials': 'H', 'LastName': 'Garrard', 'Affiliation': ''}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Juhaz', 'Affiliation': ''}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': ''}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rostron', 'Affiliation': ''}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Woods', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cornell', 'Affiliation': ''}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Pillai', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Harford', 'Affiliation': ''}, {'ForeName': 'Tabitha', 'Initials': 'T', 'LastName': 'Rees', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ivatt', 'Affiliation': ''}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Sundara Raman', 'Affiliation': ''}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Davey', 'Affiliation': ''}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Barber', 'Affiliation': ''}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Chablani', 'Affiliation': ''}, {'ForeName': 'Farooq', 'Initials': 'F', 'LastName': 'Brohi', 'Affiliation': ''}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Jagannathan', 'Affiliation': ''}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Purvis', 'Affiliation': ''}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Wetherill', 'Affiliation': ''}, {'ForeName': 'Ahilanandan', 'Initials': 'A', 'LastName': 'Dushianthan', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cusack', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'de Courcy-Golder', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jackson', 'Affiliation': ''}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Attwood', 'Affiliation': ''}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Parsons', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Page', 'Affiliation': ''}, {'ForeName': 'Xiao Bei', 'Initials': 'XB', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Deepali', 'Initials': 'D', 'LastName': 'Oza', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rhodes', 'Affiliation': ''}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Xia Le Tai', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Keen', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Digby', 'Affiliation': ''}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Cowley', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Wild', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Southern', 'Affiliation': ''}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Watkins', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Smuts', 'Affiliation': ''}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Touma', 'Affiliation': ''}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Barnes', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Alexander', 'Affiliation': ''}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Felton', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ferguson', 'Affiliation': ''}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Sellers', 'Affiliation': ''}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Bradley-Potts', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yates', 'Affiliation': ''}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Birkinshaw', 'Affiliation': ''}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Kell', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Marshall', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Carr-Knott', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.17022']
2751,32912218,Effectiveness of a health-social partnership program for discharged non-frail older adults: a pilot study.,"BACKGROUND
Previous studies supporting discharged patients are hospital-based which admission criteria tend to include mainly those with complex needs and/or specific disease conditions. This study captured the service gap where these non-frail older patients might have no specific medical problem upon discharge but they might encounter residual health and social issues when returning home.
METHODS
Discharged community-dwelling non-frail older adults from an emergency medical ward were recruited and randomized into either intervention (n = 37) or control (n = 38) group. The intervention group received a 12-week complex interventions that included structured assessment, health education, goal empowerment, and care coordination supported by a health-social team. The control group received usual discharge care and monthly social call. The primary outcome was health-related quality of life (HRQoL). Secondary outcomes included activities of daily living (ADL), the presence of depressive symptoms, and the use of health services. The outcomes were measured at pre-intervention (T1) and at three months post-intervention (T2). The independent t-test or the Mann-Whitney U test was used to analyze the group differences in HRQoL, ADL, and presence of depressive symptoms according to the normality of data.
RESULTS
Analysis showed that the intervention group experienced a statistically significantly improvement in the mental component scale of quality of life (p = .036), activities of daily living (p = .005), and presence of depressive symptoms (p = .035) at T2 compared with at T1. No significant differences were found in the control group.
CONCLUSIONS
Supporting self-care is necessary to enable community-dwelling non-frail older adults to be independent to the fullest extent possible in the community. The promising results found in this pilot study suggested that the integration of the health-social partnership into transitional care practice is effective and can be sustained in the community. Future studies can draw on these findings and maximize the integrated care quality during the transition phase.
TRIAL REGISTRATION
NCT04434742 (date: 17 June 2020, retrospectively registered).",2020,"RESULTS
Analysis showed that the intervention group experienced a statistically significantly improvement in the mental component scale of quality of life (p = .036), activities of daily living (p = .005), and presence of depressive symptoms (p = .035) at T2 compared with at T1.","['Discharged community-dwelling non-frail older adults from an emergency medical ward', 'community-dwelling non-frail older adults', 'frail older patients', '17 June 2020, retrospectively registered', 'discharged non-frail older adults']","['health-social partnership program', 'usual discharge care and monthly social call', '12-week complex interventions that included structured assessment, health education, goal empowerment, and care coordination supported by a health-social team']","['HRQoL, ADL, and presence of depressive symptoms', 'activities of daily living', 'mental component scale of quality of life', 'health-related quality of life (HRQoL', 'presence of depressive symptoms', 'activities of daily living (ADL), the presence of depressive symptoms, and the use of health services']","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]",,0.0505116,"RESULTS
Analysis showed that the intervention group experienced a statistically significantly improvement in the mental component scale of quality of life (p = .036), activities of daily living (p = .005), and presence of depressive symptoms (p = .035) at T2 compared with at T1.","[{'ForeName': 'Arkers Kwan Ching', 'Initials': 'AKC', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Frances Kam Yuet', 'Initials': 'FKY', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong. frances.wong@polyu.edu.hk.'}, {'ForeName': 'Jenny Sau Chun', 'Initials': 'JSC', 'LastName': 'Ngai', 'Affiliation': 'Queen Elizabeth Hospital, Kowloon Central Cluster, Hong Kong Hospital Authority, Kowloon, Hong Kong.'}, {'ForeName': 'Shirley Yu Kan', 'Initials': 'SYK', 'LastName': 'Hung', 'Affiliation': 'Queen Elizabeth Hospital, Kowloon Central Cluster, Hong Kong Hospital Authority, Kowloon, Hong Kong.'}, {'ForeName': 'Wah Chun', 'Initials': 'WC', 'LastName': 'Li', 'Affiliation': 'Queen Elizabeth Hospital, Kowloon Central Cluster, Hong Kong Hospital Authority, Kowloon, Hong Kong.'}]",BMC geriatrics,['10.1186/s12877-020-01722-5']
2752,32915892,"Comparison of nebivolol versus diltiazem in improving coronary artery spasm and quality of life in patients with hypertension and vasospastic angina: A prospective, randomized, double-blind pilot study.","BACKGROUND
Beta-blockers are often not the preferred treatment for patients with vasospastic angina. However, nebivolol, beta-blocker with nitric oxide-releasing effect, could theoretically improve coronary vasospasm. We compared nebivolol versus diltiazem in improving coronary vasospasm and quality of life in patients with hypertensive vasospastic angina during a 12-week follow-up.
METHODS
Fifty-one hypertensive patients with documented coronary vasospasm were randomly allocated into 3 treatment groups: (1) Nebivolol Group (5mg for 2 weeks/10mg for 10 weeks); (2) Diltiazem Group (90mg for 2 weeks/180mg for 10 weeks); (3) Low-dose Combination Group (2.5mg + 45mg for 2 weeks/5mg + 90mg for 10 weeks). The primary endpoint was to compare the percent changes in coronary vasospasm at 12 weeks from baseline among the 3 groups. The secondary endpoints included changes in quality of life based on the Seattle Angina Questionnaire and changes in blood pressure at 12 weeks from baseline.
RESULTS
Significant improvements in coronary vasospasm were found in all groups; however, the improvement in percent changes in coronary artery spasm was greatest in the Diltiazem Group (50.4±8.8% vs. 67.8±12.8% vs. 46.8±12.3%, Nebivolol Group vs. Diltiazem Group p = 0.008; Nebivolol Group vs. Low-dose Combination Group p = 0.999; Diltiazem Group vs. Low-dose Combination Group p = 0.017). The overall Seattle Angina Questionnaire scores were significantly elevated at 12 weeks compared to the baseline in entire study population. There were no significant differences between the three groups in the overall Seattle Angina Questionnaire score changes and blood pressure changes.
CONCLUSIONS
Both nebivolol and diltiazem showed significant coronary vasospasm reduction effect, but the effect was greater for diltiazem.",2020,"There were no significant differences between the three groups in the overall Seattle Angina Questionnaire score changes and blood pressure changes.
","['Fifty-one hypertensive patients with documented coronary vasospasm', 'patients with hypertensive vasospastic angina during a 12-week follow-up', 'patients with hypertension and vasospastic angina', 'patients with vasospastic angina']","['diltiazem', 'Diltiazem', 'nebivolol', 'Nebivolol', 'nebivolol and diltiazem']","['changes in quality of life based on the Seattle Angina Questionnaire and changes in blood pressure', 'overall Seattle Angina Questionnaire score changes and blood pressure changes', 'coronary vasospasm', 'coronary artery spasm and quality of life', 'coronary vasospasm and quality of life', 'coronary vasospasm reduction effect', 'overall Seattle Angina Questionnaire scores', 'coronary artery spasm']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0010073', 'cui_str': 'Coronary artery spasm'}, {'cui': 'C0002963', 'cui_str': 'Prinzmetal angina'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0012373', 'cui_str': 'Diltiazem'}, {'cui': 'C0068475', 'cui_str': 'nebivolol'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0010073', 'cui_str': 'Coronary artery spasm'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",51.0,0.050534,"There were no significant differences between the three groups in the overall Seattle Angina Questionnaire score changes and blood pressure changes.
","[{'ForeName': 'Hyungdon', 'Initials': 'H', 'LastName': 'Kook', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung-Sook', 'Initials': 'KS', 'LastName': 'Yang', 'Affiliation': 'Department of Biostatistics, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sunki', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chang Gyu', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0239039']
2753,32915904,Automated vessel density detection in fluorescein angiography images correlates with vision in proliferative diabetic retinopathy.,"PURPOSE
To investigate the correlation between quantifiable vessel density, computed in an automated fashion, from ultra-widefield fluorescein angiography (UWFFA) images from patients with proliferative diabetic retinopathy (PDR) with visual acuity and macular thickness.
METHODS
We performed a secondary analysis of a prospective randomized controlled trial. We designed and trained an algorithm to automate retinal vessel detection from input UWFFA images. We then used our algorithm to study the correlation between baseline vessel density and best corrected visual acuity (BCVA) and CRT for patients in the RECOVERY study. Reliability of the algorithm was tested using the intraclass correlation (ICC). 42 patients from the Intravitreal Aflibercept for Retinal Non-Perfusion in Proliferative Diabetic Retinopathy (RECOVERY) trial who had both baseline UWFFA images and optical coherence tomography (OCT) data were included in our study. These patients had PDR without significant center-involving diabetic macular edema (central retinal thickness [CRT] ≤320μm).
RESULTS
Our algorithm analyzed UWFFA images with a reliability measure (ICC) of 0.98. A positive correlation (r = 0.4071, p = 0.0075) was found between vessel density and BCVA. No correlation was found between vessel density and CRT.
CONCLUSIONS
Our algorithm is capable of reliably quantifying vessel density in an automated fashion from baseline UWFFA images. We found a positive correlation between computed vessel density and BCVA in PDR patients without center-involving macular edema, but not CRT.
TRANSLATIONAL RELEVANCE
Our work is the first to offer an algorithm capable of quantifying vessel density in an automated fashion from UWFFA images, allowing us to work toward studying the relationship between retinal vascular changes and important clinical endpoints, including visual acuity, in ischemic eye diseases.",2020,"We found a positive correlation between computed vessel density and BCVA in PDR patients without center-involving macular edema, but not CRT.
","['proliferative diabetic retinopathy', 'Proliferative Diabetic Retinopathy (RECOVERY) trial who had both baseline UWFFA images and optical coherence tomography (OCT) data were included in our study', '42 patients from the', 'patients with proliferative diabetic retinopathy (PDR) with visual acuity and macular thickness']","['ultra-widefield fluorescein angiography (UWFFA) images', 'Intravitreal Aflibercept']","['vessel density and BCVA', 'vessel density and CRT', 'baseline vessel density and best corrected visual acuity (BCVA', 'diabetic macular edema']","[{'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]","[{'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]",42.0,0.0724223,"We found a positive correlation between computed vessel density and BCVA in PDR patients without center-involving macular edema, but not CRT.
","[{'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Bawany', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, New York, United States of America.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Rochester, Rochester, New York, United States of America.'}, {'ForeName': 'Rajeev S', 'Initials': 'RS', 'LastName': 'Ramchandran', 'Affiliation': 'Department of Ophthalmology, University of Rochester Medical Center, Rochester, New York, United States of America.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Rochester, Rochester, New York, United States of America.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas, United States of America.'}, {'ForeName': 'Ajay E', 'Initials': 'AE', 'LastName': 'Kuriyan', 'Affiliation': 'Department of Ophthalmology, University of Rochester Medical Center, Rochester, New York, United States of America.'}]",PloS one,['10.1371/journal.pone.0238958']
2754,32919098,Evaluation of a personally-tailored opioid overdose prevention education and naloxone distribution intervention to promote harm reduction and treatment readiness in individuals actively using illicit opioids.,"BACKGROUND
Opioid overdose prevention education and naloxone distribution (OEND) programs include information on general risk factors, overdose recognition, and naloxone utilization. This study evaluated a personally-tailored OEND (PTOEND) intervention designed to promote harm reduction and treatment readiness for illicit opioid users by also including education about personal overdose-risk factors and medication for opioid use disorder (MOUD).
METHOD
A secondary analysis of a randomized controlled trial testing a Peer recovery support service (PRSS) intervention, relative to Control, in adult illicit opioid users reporting treatment for an overdose in the prior 6 months. PTOEND, a 30-minute computer-guided intervention, was administered by a research assistant at the randomization visit to all participants (N = 80). Participants completed a telephone visit 3 weeks post-randomization (n = 74) to assess changes in opioid overdose/MOUD knowledge and treatment readiness. Participants completed in-person visits at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization to assess illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors (12 months). We conducted pre-post analyses of the impact of PTOEND controlling for the PRSS effect.
RESULTS
PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05). Self-reported opioid use was significantly decreased at each follow-up (all p < 0.01). Self-reported overdose-risk behaviors decreased significantly (6.2 to 2.4, p < 0.01). A majority of participants (65 %) reported naloxone utilization.
CONCLUSIONS
PTOEND may be effective for promoting harm reduction and treatment readiness.",2020,"RESULTS
PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","['adult illicit opioid users reporting treatment for an overdose in the prior 6 months', 'individuals actively using illicit opioids']","['naloxone distribution intervention', 'Peer recovery support service (PRSS) intervention']","['Self-reported overdose-risk behaviors', 'Self-reported opioid use', 'knowledge of overdose', 'illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors', 'desire to quit all substances', 'MOUD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]",80.0,0.027065,"RESULTS
PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine 231, Albert Sabin Way, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108265']
2755,32919196,Understanding the composite dimensions of the EQ-5D: An experimental approach.,"The EQ-5D(-5L) includes two composite dimensions: ""Pain or Discomfort"" (P/D) and ""Anxiety or Depression"" (A/D), which involves an inherent ambiguity. Little is known about how these composite dimensions are interpreted across contexts where (i) individuals self-report their own health; and (ii) individuals value stylised health states. We detail the nature of the ambiguity and present experimental evidence from two large online surveys (n = 1007 and n = 1415). In one survey, individuals reported both their current health and their health at the time they felt the worst because of their health. In the other, they valued stylised EQ-5D states using Discrete Choice Experiments with duration as an attribute. In both surveys, participants were randomised into treatments in which the presentation of one of the composite dimensions was altered, or a control. Our results suggest (1) In self-report, use of the composite dimensions differs across the dimensions, with P/D used mainly to report Pain, but A/D used mainly to mean the more severe component of Anxiety and Depression. (2) In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level. (3) In valuation, the composite dimension P/D was interpreted to mean Pain, whilst the composite dimension A/D was interpreted to lie between Anxiety and Depression. We conclude that care must be taken when interpreting responses to existing health (or wellbeing) descriptive systems that rely on composite dimensions, and that caution should be applied when designing new ones.",2020,"In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level.",[],['EQ-5D'],"['Pain or Discomfort"" (P/D) and ""Anxiety or Depression"" (A/D', 'severe component of Anxiety and Depression']",[],[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.0204719,"In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McDonald', 'Affiliation': 'University of Birmingham, UK. Electronic address: r.l.mcdonald@bham.ac.uk.'}, {'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'Mullett', 'Affiliation': 'University of Warwick, UK.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Tsuchiya', 'Affiliation': 'University of Sheffield, UK.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113323']
2756,32920973,Dietary Rapeseed Oil Supplementation Reduces Hepatic Steatosis in Obese Men-A Randomized Controlled Trial.,"SCOPE
Effective treatment for obesity associated non-alcoholic fatty liver disease (NAFLD) is limited. Dietary supplementation of n-3 polyunsaturated fatty acids, specifically alpha linolenic acid (ALA), can resolve intrahepatic lipid content (IHL). This study investigates the effect of daily supplementation of either refined rapeseed (RA), containing high amounts of ALA, or refined olive (OL) oil on IHL and glucose metabolism in NAFLD patients.
METHODS AND RESULTS
27 obese men consumed an isocaloric diet including either 50 g of RA or OL daily for 8 weeks. Hepatic proton magnetic resonance spectroscopy, hyperinsulinemic-euglycemic clamp studies and blood tests are performed before and at the end of the study. At 8 weeks a significant reduction in IHL is observed for RA (13.1 ± 1.6 before versus 11.1 ± 1.6% after intervention) versus OL (13.3 ± 2.5 before versus 15.7 ± 2.7% after intervention). For RA, a 21% reduction (P < 0.02) in serum free fatty acids (FFA) and a 1.68-fold increase (P = 0.03) of serum interleukin-6 (IL-6) is observed after 8 weeks.
CONCLUSION
RA has a beneficial effect on hepatic lipid metabolism as shown by reduced IHL and serum FFA. RA induced IL-6 production seems to be liver protective confirming previous results.",2020,"For RA, a 21% reduction (P<0.02) in serum free fatty acids (FFA) and a 1.68-fold increase (P = 0.03) of serum interleukin-6 (IL-6) was observed after eight weeks.
","['27 obese men consumed an', 'Obese Men', 'NAFLD patients']","['isocaloric diet including either 50\xa0g of RA or OL', 'n-3 polyunsaturated fatty acids, specifically alpha linolenic acid (ALA', 'refined rapeseed (RA), which contains high amounts of ALA, or refined olive (OL) oil', 'Dietary Rapeseed Oil Supplementation', 'OL']","['BMI', 'serum interleukin-6 (IL-6', 'Hepatic Steatosis', 'serum free fatty acids (FFA', 'IHL and serum FFA', 'hepatic lipid metabolism', 'IHL']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034670', 'cui_str': 'Brassica rapa'}, {'cui': 'C0228539', 'cui_str': 'Olivary nucleus structure'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0072982', 'cui_str': 'Brassica Napus Oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",27.0,0.0850338,"For RA, a 21% reduction (P<0.02) in serum free fatty acids (FFA) and a 1.68-fold increase (P = 0.03) of serum interleukin-6 (IL-6) was observed after eight weeks.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kruse', 'Affiliation': 'German Institute of Human Nutrition Potsdam-Rehbruecke, Department of Clinical Nutrition, 14558, Nuthetal, Germany.'}, {'ForeName': 'Margrit', 'Initials': 'M', 'LastName': 'Kemper', 'Affiliation': 'German Institute of Human Nutrition Potsdam-Rehbruecke, Department of Clinical Nutrition, 14558, Nuthetal, Germany.'}, {'ForeName': 'Sofiya', 'Initials': 'S', 'LastName': 'Gancheva', 'Affiliation': 'German Center for Diabetes Research (DZD), München, 85764, Neuherberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Osterhoff', 'Affiliation': 'German Institute of Human Nutrition Potsdam-Rehbruecke, Department of Clinical Nutrition, 14558, Nuthetal, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Dannenberger', 'Affiliation': 'Leibniz Institute for Farm Animal Biology, Institute of Muscle Biology and Growth, 18196, Dummerstorf, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Markgraf', 'Affiliation': 'German Center for Diabetes Research (DZD), München, 85764, Neuherberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Machann', 'Affiliation': 'German Center for Diabetes Research (DZD), München, 85764, Neuherberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hierholzer', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Ernst von Bergmann Hospital, 14467, Potsdam, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': 'German Center for Diabetes Research (DZD), München, 85764, Neuherberg, Germany.'}, {'ForeName': 'Andreas F H', 'Initials': 'AFH', 'LastName': 'Pfeiffer', 'Affiliation': 'German Institute of Human Nutrition Potsdam-Rehbruecke, Department of Clinical Nutrition, 14558, Nuthetal, Germany.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000419']
2757,32931661,Analysis of chemotherapy effect on the second primary malignancy for head and neck cancer patients by a nomogram based on SEER database.,"Second primary malignancy (SPM) ranks the second leading cause of death in patients with head and neck cancer (HNC), while studies exploring the risk factors for SPM are limited. To clarify this, we investigated the relationship between the chemotherapy and SPM using the Surveillance, Epidemiology, and End Results (SEER) database. 11 345 patients initially diagnosed with HNC between 1998 and 2016 were selected from the SEER database. First, these patients were divided into two groups according to chemotherapy or not. With Fine and Gray model, the subdistribution hazard ratio (sHR) of chemotherapy was calculated based on Propensity Score Matching (PSM). Second, the 11 345 cases were randomized into a training set and a validation set. Based on the training set, the different cumulative incidence of SPMs between the patients with and without chemotherapy was estimated respectively in the high- and low-risk group according to the scores derived from a nomogram. Chemotherapy was negatively correlated to the SPMs (sHR: 0.847, 95% CI: 0.733-0.977, P = .023) by conducting competing risk analysis. With chemotherapy, forest plots showed subgroups of squamous cell carcinoma (SCC, sHR: 0.815, 95% CI: 0.7-0.948, P = .008), 50-64 years old (sHR:0.794, 95% CI: 0.655-0.962, P = .019), male (sHR:0.828, 95% CI: 0.703-0.974, P = .023), and well/moderate histological grade (sHR:0.828, 95% CI: 0.688-0.996, P = .045) were negatively correlated to SPMs; the nomogram showed the high-risk population characterized as SCC, elder age, male, and well/moderate histological grade also tended to have lower incidence of SPMs (sHR: 0.805, 95% CI: 0.669-0.969, P = .022). Despite HNC patients with characteristics of SCC, increased age, male, and well/moderate histological grade had higher risk of a SPM, they were also more likely to be benefitted from chemotherapy to avoid it.",2020,"With chemotherapy, forest plots showed subgroups of squamous cell carcinoma (SCC, sHR: 0.815, 95% CI: 0.7-0.948, P = .008), 50-64 years old (sHR:0.794, 95% CI: 0.655-0.962, P = .019), male (sHR:0.828, 95% CI: 0.703-0.974, P = .023), and well/moderate histological grade (sHR:0.828, 95% CI: 0.688-0.996, P = .045) were negatively correlated to SPMs; the nomogram showed the high-risk population characterized as SCC, elder age, male, and well/moderate histological grade also tended to have lower incidence of SPMs (sHR: 0.805, 95% CI: 0.669-0.969, P = .022).","['head and neck cancer patients by a nomogram based on SEER database', 'patients with head and neck cancer (HNC', '11\xa0345 cases', '11\xa0345 patients initially diagnosed with HNC between 1998 and 2016 were selected from the SEER database']",['Chemotherapy'],"['squamous cell carcinoma', 'cumulative incidence of SPMs', 'subdistribution hazard ratio (sHR) of chemotherapy', 'moderate histological grade', 'SPMs (sHR']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1450294', 'cui_str': 'Nomogram chart'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038111', 'cui_str': 'Saint Pierre and Miquelon'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0456201', 'cui_str': 'Histological grades'}]",11345.0,0.0359098,"With chemotherapy, forest plots showed subgroups of squamous cell carcinoma (SCC, sHR: 0.815, 95% CI: 0.7-0.948, P = .008), 50-64 years old (sHR:0.794, 95% CI: 0.655-0.962, P = .019), male (sHR:0.828, 95% CI: 0.703-0.974, P = .023), and well/moderate histological grade (sHR:0.828, 95% CI: 0.688-0.996, P = .045) were negatively correlated to SPMs; the nomogram showed the high-risk population characterized as SCC, elder age, male, and well/moderate histological grade also tended to have lower incidence of SPMs (sHR: 0.805, 95% CI: 0.669-0.969, P = .022).","[{'ForeName': 'Xinrong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'The First Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Kaibo', 'Initials': 'K', 'LastName': 'Guo', 'Affiliation': 'The First Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Yuqian', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'The First Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, P. R. China.'}]",Cancer medicine,['10.1002/cam4.3442']
2758,32932051,Measuring upper limb disability for patients with neck pain: Evaluation of the feasibility of the single arm military press (SAMP) test.,"BACKGROUND
Non-specific neck pain (NSNP) is frequently associated with upper limb disability (ULD). Consequently, evaluation of ULD using an outcome measure is necessary during the management of patients with NSNP. The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain. During the SAMP test, patients are asked to repeatedly lift a weight above their head for 30 s. The number of repetitions is counted. Its clinical utility in a patient group is still unknown.
OBJECTIVE
This study investigates the feasibility of the SAMP test from patients and clinicians' perspectives.
METHODS
Seventy female patients with NSNP were randomly allocated into one of three groups. Participants in each group completed the SAMP test using one of three proposed weights (½kg, 1 kg or 1½kg). The feasibility of the SAMP test was established using structured qualitative exit feedback interviews for patients and administrating clinicians.
RESULTS
Participants using ½kg achieved the highest number of repetitions, but a high proportion reported the weight as extremely light, whereas those who tested using the 1½kg achieved the lowest number of repetitions and participants reported the weight as being heavy. Participants tested using 1 kg achieved an average number of repetitions and a high proportion reported the weight as acceptably heavy. Clinicians and patients reported that the SAMP test was efficient and convenient.
CONCLUSION
The 1 kg SAMP test is feasible for use in female patients with NSNP. The measurement properties of the SAMP test should be determined in a patient group.",2020,The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain.,"[""patients and clinicians' perspectives"", 'patients and administrating clinicians', 'Seventy female patients with NSNP', 'female patients with NSNP', 'patients with NSNP', 'populations with neck pain', 'patients with neck pain']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],[],70.0,0.0379593,The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain.,"[{'ForeName': 'Ahmad Salah Eldin', 'Initials': 'ASE', 'LastName': 'Alreni', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: Ahmad.Alreni@uantwerpen.be.'}, {'ForeName': 'Heba Roohy', 'Initials': 'HR', 'LastName': 'Abdo Aboalmaty', 'Affiliation': 'Department of Sports Training and Kinesiology, Tanta University El-Gaish Street, Tanta Qism 2, Tanta, Garbia Government, Egypt. Electronic address: hebaabdoaboalmaty@outlook.com.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'De Hertogh', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: willem.dehertogh@uantwerpen.be.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Meirte', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: jill.meirte@uantwerpen.be.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Harrop', 'Affiliation': 'Centre for Health and Social Care Research, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: D.Harrop@shu.ac.uk.'}, {'ForeName': 'Sionnadh Mairi', 'Initials': 'SM', 'LastName': 'McLean', 'Affiliation': 'Centre for Health and Social Care Research, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: s.mclean@shu.ac.uk.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102254']
2759,32932174,"The effects of zinc supplementation on metabolic profile and oxidative stress in overweight/obese patients with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trial.","BACKGROUND
Evidence indicates the positive effects of zinc on insulin resistance and oxidative stress in metabolic syndrome or diabetes. Non-alcoholic fatty liver disease (NAFLD) is the main hepatic manifestation of insulin resistance and metabolic syndrome. The present study is the first clinical trial that evaluated the effects of zinc supplementation on metabolic and oxidative stress status in overweight/obese patients with NAFLD undergoing calorie- restriction diet.
METHODS
Fifty six overweight/obese patients with confirmed mild to moderate NAFLD using ultrasonography were randomly allocated to receive 30 mg elemental zinc supplement (n = 29) or placebo (n = 27) along with weight loss diet for 12 weeks. Serum levels of zinc, homeostasis model of assessment-estimated insulin resistance (HOMA-IR), lipid profile, serum superoxide dismutas1 (SOD1) and malondialdhyde (MDA) levels were assessed.
RESULTS
Serum levels of insulin, SOD1, MDA and HOMA-IR were improved in the treatment group (p < 0.05). Within group comparison showed significant reduction in serum FBS, HbA 1C , TC, LDL-c and TG in the treatment group.
CONCLUSION
Zinc supplementation for three months improved insulin resistance and oxidative stress status in overweight/obese NAFLD patients with no beneficial effects on lipid profiles over weight loss diet. Registration ID in IRCT (IRCT NO: 20181005041238N1).",2020,"RESULTS
Serum levels of insulin, SOD1, MDA and HOMA-IR were improved in the treatment group (p < 0.05).","['alcoholic fatty liver disease (NAFLD', 'overweight/obese patients with non-alcoholic fatty liver disease', 'metabolic syndrome or diabetes', 'overweight/obese patients with NAFLD undergoing calorie- restriction diet', 'overweight/obese NAFLD patients', 'Fifty six overweight/obese patients with confirmed mild to moderate NAFLD using ultrasonography']","['Zinc supplementation', '30\u202fmg elemental zinc supplement', 'IRCT', 'placebo', 'zinc supplementation']","['Serum levels of insulin, SOD1, MDA and HOMA-IR', 'serum FBS, HbA 1C , TC, LDL-c and TG', 'metabolic and oxidative stress status', 'insulin resistance and oxidative stress status', 'Serum levels of zinc, homeostasis model of assessment-estimated insulin resistance (HOMA-IR), lipid profile, serum superoxide dismutas1 (SOD1) and malondialdhyde (MDA) levels', 'metabolic profile and oxidative stress']","[{'cui': 'C0015696', 'cui_str': 'Alcoholic fatty liver'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0038836', 'cui_str': 'Superoxide'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}]",56.0,0.385469,"RESULTS
Serum levels of insulin, SOD1, MDA and HOMA-IR were improved in the treatment group (p < 0.05).","[{'ForeName': 'Mojdeh', 'Initials': 'M', 'LastName': 'Fathi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Pezhman', 'Initials': 'P', 'LastName': 'Alavinejad', 'Affiliation': 'Alimentary Tract Research Center, Ahvaz Imam Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Haidari', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Amani', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: r_amani@mail.mui.ac.ir.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126635']
2760,32936837,Implementation of a complex intervention to improve care for patients whose situations are clinically uncertain in hospital settings: A multi-method study using normalisation process theory.,"PURPOSE
To examine the use of Normalisation Process Theory (NPT) to establish if, and in what ways, the AMBER care bundle can be successfully normalised into acute hospital practice, and to identify necessary modifications to optimise its implementation.
METHOD
Multi-method process evaluation embedded within a mixed-method feasibility cluster randomised controlled trial in two district general hospitals in England. Data were collected using (i) focus groups with health professionals (HPs), (ii) semi-structured interviews with patients and/or carers, (iii) non-participant observations of multi-disciplinary team meetings and (iv) patient clinical note review. Thematic analysis and descriptive statistics, with interpretation guided by NPT components (coherence; cognitive participation; collective action; reflexive monitoring). Data triangulated across sources.
RESULTS
Two focus groups (26 HPs), nine non-participant observations, 12 interviews (two patients, 10 relatives), 29 clinical note reviews were conducted. While coherence was evident, with HPs recognising the value of the AMBER care bundle, cognitive participation and collective action presented challenges. Specifically: (1) HPs were unable and unwilling to operationalise the concept of 'risk of dying' intervention eligibility criteria (2) integration relied on a 'champion' to drive participation and ensure sustainability; and (3) differing skills and confidence led to variable engagement with difficult conversations with patients and families about, for example, nearness to end of life. Opportunities for reflexive monitoring were not routinely embedded within the intervention. Reflections on the use of the AMBER care bundle from HPs and patients and families, including recommended modifications became evident through this NPT-driven analysis.
CONCLUSION
To be successfully normalised, new clinical practices, such as the AMBER care bundle, must be studied within the wider context in which they operate. NPT can be used to the aid identification of practical strategies to assist in normalisation of complex interventions where the focus of care is on clinical uncertainty in acute hospital settings.",2020,NPT can be used to the aid identification of practical strategies to assist in normalisation of complex interventions where the focus of care is on clinical uncertainty in acute hospital settings.,"['Two focus groups (26 HPs), nine non-participant observations, 12 interviews (two patients, 10 relatives), 29 clinical note reviews were conducted', 'two district general hospitals in England', 'patients whose situations are clinically uncertain in hospital settings']","['Normalisation Process Theory (NPT', 'complex intervention', 'health professionals (HPs), (ii) semi-structured interviews with patients and/or carers, (iii) non-participant observations of multi-disciplinary team meetings and (iv) patient clinical note review', 'NPT']",[],"[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0558037', 'cui_str': 'Non-participant observation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0558037', 'cui_str': 'Non-participant observation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0589031', 'cui_str': 'Team meeting'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",[],2.0,0.0411618,NPT can be used to the aid identification of practical strategies to assist in normalisation of complex interventions where the focus of care is on clinical uncertainty in acute hospital settings.,"[{'ForeName': 'Halle', 'Initials': 'H', 'LastName': 'Johnson', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Yorganci', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Evans', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Barclay', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, Cambridgeshire, United Kingdom.'}, {'ForeName': 'Fliss E M', 'Initials': 'FEM', 'LastName': 'Murtagh', 'Affiliation': 'Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, United Kingdom.'}, {'ForeName': 'Deokhee', 'Initials': 'D', 'LastName': 'Yi', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Sampson', 'Affiliation': 'Marie Curie Palliative Care Research Department, University College London, London, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Droney', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'Farquhar', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Koffman', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}]",PloS one,['10.1371/journal.pone.0239181']
2761,32939597,Assessing sleep-wake survival dynamics in relation to sleep quality in a placebo-controlled pharmacological intervention study with people with insomnia and healthy controls.,"RATIONALE
The mechanisms underlying impaired sleep quality in insomnia are not fully known, but an important role for sleep fragmentation has been proposed.
OBJECTIVES
The aim of this study is to explore potential mechanisms of sleep fragmentation influencing alterations of perceived sleep quality.
METHODS
We analyzed polysomnography (PSG) recordings from a double-blind crossover study with zopiclone 7.5 mg and placebo, in elderly participants with insomnia complaints and age-matched healthy controls. We compared survival dynamics of sleep and wake across group and treatment. Subsequently, we used a previously proposed model to estimate the amount of sleep onset latency (SOL) misperception from PSG-defined sleep fragmentation. Self-reported and model-estimated amount of SOL misperception were compared across group and treatment, as well as model prediction errors.
RESULTS
In the zopiclone night, the average segment length of NREM sleep was increased (group F = 1.16, p = 0.32; treatment F = 8.89, p < 0.01; group x treatment F = 0.44, p = 0.65), while the segment length of wake was decreased (group F = 1.48, p = 0.23; treatment F = 11.49, p < 0.01; group x treatment F = 0.36, p = 0.70). The self-reported and model-estimated amount of SOL misperception were lower during the zopiclone night (self-reported group F = 6.08, p < 0.01, treatment F = 10.8, p < 0.01, group x treatment F = 2.49, p = 0.09; model-estimated F = 1.70, p = 0.19, treatment F = 16.1, p < 0.001, group x treatment F = 0.60, p = 0.55). The prediction error was not altered (group F = 1.62, p = 0.20; treatment F = 0.20, p = 0.65; group x treatment F = 1.01, p = 0.37).
CONCLUSIONS
Impaired subjective sleep quality is associated with decreased NREM stability, together with increased stability of wake. Furthermore, we conclude that zopiclone-induced changes in SOL misperception can be largely attributed to predictable changes of sleep architecture.",2020,"The self-reported and model-estimated amount of SOL misperception were lower during the zopiclone night (self-reported group F = 6.08, p < 0.01, treatment F = 10.8, p < 0.01, group x treatment F = 2.49, p = 0.09; model-estimated F = 1.70, p = 0.19, treatment F = 16.1, p < 0.001, group x treatment F = 0.60, p = 0.55).","['people with insomnia and healthy controls', 'elderly participants with insomnia complaints and age-matched healthy controls']","['zopiclone 7.5 mg and placebo', 'placebo-controlled pharmacological intervention']","['survival dynamics of sleep', 'SOL misperception', 'segment length of wake', 'average segment length of NREM sleep']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C1128536', 'cui_str': 'zopiclone 7.5 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}]",,0.024048,"The self-reported and model-estimated amount of SOL misperception were lower during the zopiclone night (self-reported group F = 6.08, p < 0.01, treatment F = 10.8, p < 0.01, group x treatment F = 2.49, p = 0.09; model-estimated F = 1.70, p = 0.19, treatment F = 16.1, p < 0.001, group x treatment F = 0.60, p = 0.55).","[{'ForeName': 'Lieke W A', 'Initials': 'LWA', 'LastName': 'Hermans', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands. l.w.a.hermans@tue.nl.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Regis', 'Affiliation': 'Department of Mathematics and Computer Science, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Fonseca', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Overeem', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Tim R M', 'Initials': 'TRM', 'LastName': 'Leufkens', 'Affiliation': 'Philips Research, High Tech Campus 34, Eindhoven, The Netherlands.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Vermeeren', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, Maastricht, The Netherlands.'}, {'ForeName': 'Merel M', 'Initials': 'MM', 'LastName': 'van Gilst', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}]",Psychopharmacology,['10.1007/s00213-020-05660-3']
2762,32940257,Cardiovascular system parameters in participants of Arctic expeditions.,"OBJECTIVES
A method of continuous heart rate (HR) and blood pressure (BP) recording was used for the evaluation of the cardiovascular system parameters in participants of short-term (<1 month) high-latitude expeditions, in comparison with the parameters of residents of Central Russia and the Arctic region.
MATERIAL AND METHODS
A dynamic examination of participants of Arctic expeditions (30 men, residents of middle-latitude regions, aged 46.7±1.7 years), workers permanently living in Central Russia (the Moscow region, 44 men, aged 46.7±1.0 years) and residents of the North (the Murmansk region, 35 men, aged 46.6±1.3 years) was performed. The authors used a spiroartheriocardiorythmograph allowing the parallel recording of HR, BP, spectral characteristics of HR variability (HRV) and the variability of systolic BP (sBP) and diastolic BP (dBP), cardiac performance parameters, and spontaneous baroreflex sensitivity (BRS). The parameters were recorded at rest, in a sitting position, over 2 min.
RESULTS
The basic clinical parameters (HR, BP and cardiac performance) did not differ in the workers living in different climatic zones. However, the residents of the North demonstrated a lower total power (TP) of the dBP variability spectrum and a lower relative power of the high-frequency (HF) range in both the sBP and dBP variability spectra. The participants of expeditions to the North had a lower TP of the HRV spectrum (in comparison with both control groups) that did not change during the expeditions; BRS was reduced, while the TP of the sBP spectrum was increased in comparison with the corresponding parameters obtained from the residents of circumpolar regions, and decreased during the expedition in parallel with a decrease in the sBP values. The TP of both the sBP and dBP variability spectra, as well as the power of the HF range in these spectra, were similar in the participants of expeditions to those obtained from the residents of Central Russia, and they considerably surpassed the corresponding parameters in the northerners surveyed.
CONCLUSIONS
The revealed peculiarities of the cardiovascular system in the participants of high-latitude expeditions can be considered as correlates of positive, and adequate in terms of the physiological value, adaptive shifts in the autonomous regulation of the cardiovascular system. Int J Occup Med Environ Health. 2020;33(6):819-28.",2020,"The basic clinical parameters (HR, BP and cardiac performance) did not differ in the workers living in different climatic zones.","['participants of short-term (<1 month) high-latitude expeditions, in comparison with the parameters of residents of Central Russia and the Arctic region', 'participants of Arctic expeditions', 'participants of Arctic expeditions (30 men, residents of middle-latitude regions, aged 46.7±1.7 years), workers permanently living in Central Russia (the Moscow region, 44 men, aged 46.7±1.0 years) and residents of the North (the Murmansk region, 35 men, aged 46.6±1.3 years']",[],"['TP of the sBP spectrum', 'HR, BP, spectral characteristics of HR variability (HRV) and the variability of systolic BP (sBP) and diastolic BP (dBP), cardiac performance parameters, and spontaneous baroreflex sensitivity (BRS', 'lower TP of the HRV spectrum', 'lower total power (TP) of the dBP variability spectrum', 'sBP values', 'basic clinical parameters (HR, BP and cardiac performance', 'continuous heart rate (HR) and blood pressure (BP']","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015315', 'cui_str': 'Expeditions'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0003740', 'cui_str': 'Arctic Regions'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0026580', 'cui_str': 'Moscow'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",44.0,0.0311069,"The basic clinical parameters (HR, BP and cardiac performance) did not differ in the workers living in different climatic zones.","[{'ForeName': 'Nataliya B', 'Initials': 'NB', 'LastName': 'Pankova', 'Affiliation': 'Institute of General Pathology and Pathophysiology, Moscow, Russia (Laboratory of Physical, Chemical and Ecological Pathophysiology).'}, {'ForeName': 'Irina B', 'Initials': 'IB', 'LastName': 'Alchinova', 'Affiliation': 'Institute of General Pathology and Pathophysiology, Moscow, Russia (Laboratory of Physical, Chemical and Ecological Pathophysiology).'}, {'ForeName': 'Anton B', 'Initials': 'AB', 'LastName': 'Cherepov', 'Affiliation': 'Institute of General Pathology and Pathophysiology, Moscow, Russia (Laboratory of Physical, Chemical and Ecological Pathophysiology).'}, {'ForeName': 'Elena N', 'Initials': 'EN', 'LastName': 'Yakovenko', 'Affiliation': 'Institute of General Pathology and Pathophysiology, Moscow, Russia (Laboratory of Physical, Chemical and Ecological Pathophysiology).'}, {'ForeName': 'Mikhail Y', 'Initials': 'MY', 'LastName': 'Karganov', 'Affiliation': 'Institute of General Pathology and Pathophysiology, Moscow, Russia (Laboratory of Physical, Chemical and Ecological Pathophysiology).'}]",International journal of occupational medicine and environmental health,['10.13075/ijomeh.1896.01628']
2763,32943015,Can cardiovascular risk management be improved by shared care with general practice to prevent cognitive decline following stroke/TIA? A feasibility randomised controlled trial (SERVED memory).,"BACKGROUND
Cognitive impairment and dementia following cerebrovascular disease are increasingly common in the UK. One potential strategy to prevent post-stroke cognitive decline is multimodal vascular risk factor management. However, its efficacy remains uncertain and its application in vulnerable patients with incident cerebrovascular disease and early cognitive impairment has not been assessed. The primary aim of this study was to assess the feasibility of recruitment and retention of patients with early cognitive impairment post-stroke or transient ischaemic attack (TIA) to a trial of enhanced vascular risk factor management combining primary and secondary care.
METHODS
In this single centre, open label trial adults with a recent stroke or TIA and mild cognitive impairment (MCI) were randomised 1:1 to a three-monthly multimodal vascular risk factor intervention jointly delivered by the trial team and General Practitioner (GP), or control (defined as usual care from the GP). Chosen risk factors were blood pressure (BP), total cholesterol, blood glucose (HbA1C) in those with diabetes, and heart rate and adequacy of anticoagulation in those with atrial fibrillation (AF). Similar patients with normal cognition were enrolled in an embedded observational cohort and also received usual care from the GP. Repeat cognitive screening was undertaken in all participants after 12 months.
RESULTS
Seventy three participants were recruited to the randomised trial and 94 to the observational cohort (21.8% of those screened). From the randomised trial 35/73 (47.9%) dropped out before final follow-up. In all groups guideline based rates of risk factor control were mostly poor at baseline and did not significantly improve during follow-up. The observational cohort demonstrated greater decline in cognitive test scores at 12 months, with no difference between the randomised groups.
CONCLUSIONS
Recruitment to such a study was feasible, but retention of participants was difficult and generally poor rates of risk factor control suggested insufficient application of the intervention. Consequently, successful scaling up of the trial would require protocol changes with less reliance on primary care services. Any future trial should include participants with normal cognition post-stroke as they may be at greatest risk of cognitive decline.
TRIAL REGISTRATION
ISRCTN, ISRCTN42688361 . Registered 16 April 2015.",2020,In all groups guideline based rates of risk factor control were mostly poor at baseline and did not significantly improve during follow-up.,"['Seventy', 'vulnerable patients with incident cerebrovascular disease and early cognitive impairment', 'three participants were recruited to the randomised trial and 94 to the observational cohort (21.8% of those screened', 'patients with early cognitive impairment post-stroke or transient ischaemic attack (TIA', 'Similar patients with normal cognition', 'open label trial adults with a recent stroke or TIA and mild cognitive impairment (MCI', 'participants with normal cognition post-stroke']","['multimodal vascular risk factor intervention jointly delivered by the trial team and General Practitioner (GP), or control (defined as usual care from the GP', 'usual care from the GP']","['heart rate and adequacy of anticoagulation', 'cognitive test scores', 'rates of risk factor control', 'Repeat cognitive screening', 'blood pressure (BP), total cholesterol, blood glucose (HbA1C']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C2712133', 'cui_str': 'Normal cognition'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",73.0,0.232762,In all groups guideline based rates of risk factor control were mostly poor at baseline and did not significantly improve during follow-up.,"[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Davison', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Bob Champion Research Building, James Watson Road, Norwich, UK.'}, {'ForeName': 'Phyo K', 'Initials': 'PK', 'LastName': 'Myint', 'Affiliation': 'Ageing Clinical & Experimental Research Team (ACER), Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Yoon K', 'Initials': 'YK', 'LastName': 'Loke', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Garth', 'Initials': 'G', 'LastName': 'Ravenhill', 'Affiliation': 'Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Shepstone', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Potter', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Bob Champion Research Building, James Watson Road, Norwich, UK. john.potter@uea.ac.uk.'}]",BMC geriatrics,['10.1186/s12877-020-01760-z']
2764,32908282,Insulin dose optimization using an automated artificial intelligence-based decision support system in youths with type 1 diabetes.,"Despite the increasing adoption of insulin pumps and continuous glucose monitoring devices, most people with type 1 diabetes do not achieve their glycemic goals 1 . This could be related to a lack of expertise or inadequate time for clinicians to analyze complex sensor-augmented pump data. We tested whether frequent insulin dose adjustments guided by an automated artificial intelligence-based decision support system (AI-DSS) is as effective and safe as those guided by physicians in controlling glucose levels. ADVICE4U was a six-month, multicenter, multinational, parallel, randomized controlled, non-inferiority trial in 108 participants with type 1 diabetes, aged 10-21 years and using insulin pump therapy (ClinicalTrials.gov no. NCT03003806). Participants were randomized 1:1 to receive remote insulin dose adjustment every three weeks guided by either an AI-DSS, (AI-DSS arm, n = 54) or by physicians (physician arm, n = 54). The results for the primary efficacy measure-the percentage of time spent within the target glucose range (70-180 mg dl -1 (3.9-10.0 mmol l -1 ))-in the AI-DSS arm were statistically non-inferior to those in the physician arm (50.2 ± 11.1% versus 51.6 ± 11.3%, respectively, P < 1 × 10 -7 ). The percentage of readings below 54 mg dl -1 (<3.0 mmol l -1 ) within the AI-DSS arm was statistically non-inferior to that in the physician arm (1.3 ± 1.4% versus 1.0 ± 0.9%, respectively, P < 0.0001). Three severe adverse events related to diabetes (two severe hypoglycemia, one diabetic ketoacidosis) were reported in the physician arm and none in the AI-DSS arm. In conclusion, use of an automated decision support tool for optimizing insulin pump settings was non-inferior to intensive insulin titration provided by physicians from specialized academic diabetes centers.",2020,"In conclusion, use of an automated decision support tool for optimizing insulin pump settings was non-inferior to intensive insulin titration provided by physicians from specialized academic diabetes centers.","['youths with type 1 diabetes', '108 participants with type 1 diabetes, aged 10-21 years and using insulin pump therapy (ClinicalTrials.gov no']","['Insulin dose optimization using an automated artificial intelligence-based decision support system', 'remote insulin dose adjustment every three weeks guided by either an AI-DSS', 'frequent insulin dose adjustments guided by an automated artificial intelligence-based decision support system (AI-DSS']","['percentage of time spent within the target glucose range', 'severe hypoglycemia, one diabetic ketoacidosis']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}]",108.0,0.0687685,"In conclusion, use of an automated decision support tool for optimizing insulin pump settings was non-inferior to intensive insulin titration provided by physicians from specialized academic diabetes centers.","[{'ForeName': 'Revital', 'Initials': 'R', 'LastName': 'Nimri', 'Affiliation': ""The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': ""Department of Endocrinology, Diabetes and Metabolic Diseases, UMC-University Children's Hospital Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.""}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Joslin Diabetes Center, One Joslin Place, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Slover', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Schatz', 'Affiliation': 'Department of Pediatrics, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Weinzimer', 'Affiliation': 'Pediatric Endocrinology & Diabetes, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Klemen', 'Initials': 'K', 'LastName': 'Dovc', 'Affiliation': ""Department of Endocrinology, Diabetes and Metabolic Diseases, UMC-University Children's Hospital Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Diabetes Center for Children and Adolescents, Children's Hospital AUF DER BULT, Hannover, Germany.""}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. mosheph@tauex.tau.ac.il.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nature medicine,['10.1038/s41591-020-1045-7']
2765,32909826,Maturity Progression of the Entire Anterior Cruciate Ligament Graft of Insertion-Preserved Hamstring Tendons by 5 Years: A Prospective Randomized Controlled Study Based on Magnetic Resonance Imaging Evaluation.,"BACKGROUND
It has been reported that insertion-preserved hamstring tendon autografts (IP-HT) have better maturity than free hamstring tendon autografts (FHT) at 2 years after anterior cruciate ligament reconstruction (ACLR); however, whether insertion preservation improves the maturity of the entire autograft and clinical outcomes at 5 years after ACLR is still unclear.
PURPOSE
To investigate the clinical outcomes and maturity of different segments using insertion-preserved and free hamstring tendon autografts up to 5 years after ACLR.
STUDY DESIGN
Randomized controlled trial; Level of evidence, 2.
METHODS
45 patients who underwent isolated ACLR with hamstring tendon autografts were enrolled and randomized into 2 groups. The study group had ACLR with IP-HT, whereas the control group had ACLR with FHT. The International Knee Documentation Committee and Tegner scores, Lysholm activity score, and KT-1000 arthrometer measurements were evaluated preoperatively and at 6, 12, 24, and 60 months postoperatively. Three-dimensional-reconstruction MRI examinations were performed at 6, 12, 24, and 60 months to evaluate the signal/noise quotient (SNQ) values of femoral tunnel graft, intra-articular graft, and tibial tunnel graft.
RESULTS
At 60 months, the SNQ values of the intra-articular and tunnel sections for the grafts in both groups showed no difference; the clinical outcomes were improved compared with before surgery ( P < .001) and were similar in both groups. In the early stage, all graft segments in the IP-HT group had lower SNQ values than those of the FHT group. At 6 months, the entire graft in the FHT group and the femoral tunnel section in the IP-HT group had the maximum SNQ values, whereas the femoral tunnel graft had the highest SNQ value compared with intra-articular and tibial tunnel graft in each group. SNQ values of the intra-articular and tibial tunnel graft in the IP-HT group had no significant change within 60 months.
CONCLUSION
All patients had similar clinical outcomes and graft maturity at 60 months postoperatively. The SNQ values and progressions varied at different graft sites and were highest for the femoral tunnel graft. All significantly changing SNQ values reached the maximum value at 6 months. Compared with FHT autograft, the graft maturity of IP-HT autograft recovered earlier and appeared more stable within the 60-month follow-up; however, no significant association was found between graft maturity and clinical scores.",2020,"SNQ values of the intra-articular and tibial tunnel graft in the IP-HT group had no significant change within 60 months.
","['Maturity Progression of the Entire Anterior Cruciate Ligament Graft of Insertion-Preserved Hamstring Tendons by 5 Years', '45 patients who underwent isolated ACLR with hamstring tendon autografts']","['insertion-preserved and free hamstring tendon autografts', 'hamstring tendon autografts (FHT', 'FHT autograft', 'Magnetic Resonance Imaging Evaluation', 'FHT', 'ACLR with IP-HT', 'insertion-preserved hamstring tendon autografts (IP-HT']","['SNQ values', 'clinical outcomes', 'International Knee Documentation Committee and Tegner scores, Lysholm activity score, and KT-1000 arthrometer measurements', 'SNQ values of the intra-articular and tunnel sections', 'maximum SNQ values', 'graft maturity and clinical scores', 'ACLR with FHT', 'SNQ values of the intra-articular and tibial tunnel graft', 'signal/noise quotient (SNQ) values of femoral tunnel graft, intra-articular graft, and tibial tunnel graft', 'femoral tunnel section']","[{'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1748452', 'cui_str': 'Entire anterior cruciate ligament of knee joint'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C1267157', 'cui_str': 'Hamstring Tendons'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1267157', 'cui_str': 'Hamstring Tendons'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0183894', 'cui_str': 'Arthrometer'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1267157', 'cui_str': 'Hamstring Tendons'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",45.0,0.0372722,"SNQ values of the intra-articular and tibial tunnel graft in the IP-HT group had no significant change within 60 months.
","[{'ForeName': 'Yuhan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Sports Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Sports Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Qingyan', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Biology, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Radiology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yaying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Sports Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiwu', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Sports Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}]",The American journal of sports medicine,['10.1177/0363546520951507']
2766,32911132,A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial.,"BACKGROUND
Medication for opioid use disorder (MOUD) can decrease the risk of opioid overdose (OOD) in individuals with opioid use disorder. Peer recovery support services (PRSS) are increasingly used to promote MOUD engagement but evidence of their efficacy is limited. This study's objective was to evaluate a single 20-minute telephone-delivered PRSS intervention for increasing MOUD enrollment and decreasing recurring OODs.
METHOD
This single-site, randomized controlled pilot trial enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months. Participants (N = 80) were randomized to PRSS (n = 40) or Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone. Outcome measures obtained at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization included verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS.
RESULTS
Through 12-month follow-up, 32.5 % of PRSS, compared to 17.5 % of Control participants enrolled in MOUD (X 2 = 2.4, p = 0.12; odds ratio = 2.27 (0.79-6.49)). PRSS participants were significantly less likely to have experienced an OOD through 12-month follow-up (12.5 % of PRSS participants, 32.5 % of Control, p = 0.03). No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days. Based on self-report, PRSS had good acceptability for both the interventionists and participants.
CONCLUSIONS
The results suggest that further development and testing of this PRSS telephone intervention to encourage MOUD enrollment and reduce OOD may be warranted.",2020,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"['individuals with opioid use disorder', 'Participants (N = 80', 'individuals surviving an opioid overdose', 'enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months']","['PRSS', 'PRSS telephone intervention', 'Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone', 'Peer recovery support services (PRSS', 'telephone-delivered PRSS intervention', 'telephone-delivered peer intervention']","['verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0743300', 'cui_str': 'Urine drug screen positive'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}]",80.0,0.0748964,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108270']
2767,32911462,On-Site Computed Tomography Versus Angiography Alone to Guide Coronary Stent Implantation: A Prospective Randomized Study.,"OBJECTIVES
The effect of intraprocedural coronary computed tomography angiography (coronary CTA) guidance on percutaneous coronary intervention (PCI) is unknown. We sought to determine the influence of CTA guidance on procedural strategies and immediate angiographic outcomes of PCI.
METHODS
Sixty patients were randomized to CTA-guided PCI (29 patients, 36 lesions) or angiography-guided PCI (31 patients, 39 lesions). To enable hands-free manipulation of CTA images by the interventional cardiologist during PCI, we developed an onsite augmented-reality (AR) system comprising a mobile application and AR glass. The primary endpoints were defined as: (1) stent length; and (2) largest stent diameter according to compliance chart. Procedural strategies, two-dimensional (2D) and three-dimensional (3D) quantitative coronary angiography (QCA), and safety outcomes were compared.
RESULTS
Whereas CTA guidance resulted in significantly higher frequency of stent postdilation using non-compliant (67% vs 31%; P<.01) and shorter balloons (16.6 ± 5.4 mm vs 20.5 ± 9.4 mm; P=.04) with numerically larger diameter (3.50 ± 0.63 mm vs 3.28 ± 0.45 mm; P=.10), it did not differ from angiography guidance with respect to lesion predilation, stent length, largest stent diameter according to compliance chart, and nominal stent diameter. The results of 2D- and 3D-QCA and safety outcomes were similar between groups. Neither death nor stroke occurred in either group.
CONCLUSIONS
PCI under intraprocedural CTA guidance is associated with similar stent size selection and more frequent stent postdilation, resulting in comparable immediate angiographic and safety outcomes as compared with PCI under angiographic guidance alone.",2020,"CONCLUSIONS
PCI under intraprocedural CTA guidance is associated with similar stent size selection and more frequent stent postdilation, resulting in comparable immediate angiographic and safety outcomes as compared with PCI under angiographic guidance alone.","['29 patients, 36 lesions) or', 'Sixty patients']","['angiography-guided PCI', 'CTA-guided PCI', 'intraprocedural coronary computed tomography angiography (coronary CTA) guidance', 'CTA guidance', 'Site Computed Tomography Versus Angiography Alone to Guide Coronary Stent Implantation']","['2D- and 3D-QCA and safety outcomes', 'death nor stroke', 'Procedural strategies, two-dimensional (2D) and three-dimensional (3D) quantitative coronary angiography (QCA), and safety outcomes', 'stent length; and (2) largest stent diameter according to compliance chart', 'frequency of stent postdilation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0449462', 'cui_str': 'Length of stent'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",60.0,0.0852343,"CONCLUSIONS
PCI under intraprocedural CTA guidance is associated with similar stent size selection and more frequent stent postdilation, resulting in comparable immediate angiographic and safety outcomes as compared with PCI under angiographic guidance alone.","[{'ForeName': 'Maksymilian P', 'Initials': 'MP', 'LastName': 'Opolski', 'Affiliation': 'Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Alpejska 42, 04-628 Warsaw, Poland. opolski.mp@gmail.com.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Schumacher', 'Affiliation': ''}, {'ForeName': 'Niels J W', 'Initials': 'NJW', 'LastName': 'Verouden', 'Affiliation': ''}, {'ForeName': 'Pepijn A', 'Initials': 'PA', 'LastName': 'van Diemen', 'Affiliation': ''}, {'ForeName': 'Bartosz A', 'Initials': 'BA', 'LastName': 'Borucki', 'Affiliation': ''}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Sprengers', 'Affiliation': ''}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Everaars', 'Affiliation': ''}, {'ForeName': 'Ruben W', 'Initials': 'RW', 'LastName': 'de Winter', 'Affiliation': ''}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'van Rossum', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nap', 'Affiliation': ''}, {'ForeName': 'Michiel J', 'Initials': 'MJ', 'LastName': 'Bom', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Knaapen', 'Affiliation': ''}]",The Journal of invasive cardiology,[]
2768,32912323,Comparing effects of two higher intensity feedback interventions with simple feedback on improving staff communication in nursing homes-the INFORM cluster-randomized controlled trial.,"BACKGROUND
Effective communication among interdisciplinary healthcare teams is essential for quality healthcare, especially in nursing homes (NHs). Care aides provide most direct care in NHs, yet are rarely included in formal communications about resident care (e.g., change of shift reports, family conferences). Audit and feedback is a potentially effective improvement intervention. This study compares the effect of simple and two higher intensity levels of feedback based on goal-setting theory on improving formal staff communication in NHs.
METHODS
This pragmatic three-arm parallel cluster-randomized controlled trial included NHs participating in TREC (translating research in elder care) across the Canadian provinces of Alberta and British Columbia. Facilities with at least one care unit with 10 or more care aide responses on the TREC baseline survey were eligible. At baseline, 4641 care aides and 1693 nurses cared for 8766 residents in 67 eligible NHs. NHs were randomly allocated to a simple (control) group (22 homes, 60 care units) or one of two higher intensity feedback intervention groups (based on goal-setting theory): basic assisted feedback (22 homes, 69 care units) and enhanced assisted feedback 2 (23 homes, 72 care units). Our primary outcome was the amount of formal communication about resident care that involved care aides, measured by the Alberta Context Tool and presented as adjusted mean differences [95% confidence interval] between study arms at 12-month follow-up.
RESULTS
Baseline and follow-up data were available for 20 homes (57 care units, 751 care aides, 2428 residents) in the control group, 19 homes (61 care units, 836 care aides, 2387 residents) in the basic group, and 14 homes (45 care units, 615 care aides, 1584 residents) in the enhanced group. Compared to simple feedback, care aide involvement in formal communications at follow-up was 0.17 points higher in both the basic ([0.03; 0.32], p = 0.021) and enhanced groups ([0.01; 0.33], p = 0.035). We found no difference in this outcome between the two higher intensity groups.
CONCLUSIONS
Theoretically informed feedback was superior to simple feedback in improving care aides' involvement in formal communications about resident care. This underlines that prior estimates for efficacy of audit and feedback may be constrained by the type of feedback intervention tested.
TRIAL REGISTRATION
ClinicalTrials.gov ( NCT02695836 ), registered on March 1, 2016.",2020,"Compared to simple feedback, care aide involvement in formal communications at follow-up was 0.17 points higher in both the basic ([0.03; 0.32], p = 0.021) and enhanced groups ([0.01; 0.33], p = 0.035).","['nursing homes', '20 homes (57 care units, 751 care aides, 2428 residents) in the control group, 19 homes (61 care units, 836 care aides, 2387 residents) in the basic group, and 14 homes (45 care units, 615 care aides, 1584 residents) in the enhanced group', '23 homes, 72 care units', 'NHs participating in TREC (translating research in elder care) across the Canadian provinces of Alberta and British Columbia', 'NHs', 'Facilities with at least one care unit with 10 or more care aide responses on the TREC baseline survey were eligible', '4641 care aides and 1693 nurses cared for 8766 residents in 67 eligible NHs']","['simple (control) group (22 homes, 60 care units) or one of two higher intensity feedback intervention groups (based on goal-setting theory): basic assisted feedback (22 homes, 69 care units) and enhanced assisted feedback 2', 'two higher intensity feedback interventions with simple feedback']","['amount of formal communication about resident care that involved care aides, measured by the Alberta Context Tool']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5192273', 'cui_str': '615'}, {'cui': 'C1515131', 'cui_str': 'T-cell receptor excision circle'}, {'cui': 'C0040710', 'cui_str': 'Translating'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]",,0.100811,"Compared to simple feedback, care aide involvement in formal communications at follow-up was 0.17 points higher in both the basic ([0.03; 0.32], p = 0.021) and enhanced groups ([0.01; 0.33], p = 0.035).","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hoben', 'Affiliation': 'Faculty of Nursing, University of Alberta, 11405 87 Avenue, Edmonton, Alberta, T6G 1C9, Canada. mhoben@ualberta.ca.'}, {'ForeName': 'Liane R', 'Initials': 'LR', 'LastName': 'Ginsburg', 'Affiliation': 'School of Health Policy & Management, Faculty of Health, York University, Toronto, Ontario, M3J 1P3, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Easterbrook', 'Affiliation': 'Faculty of Nursing, University of Alberta, 11405 87 Avenue, Edmonton, Alberta, T6G 1C9, Canada.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Norton', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, Alberta, T2N 4\u2009N1, Canada.'}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Anderson', 'Affiliation': 'School of Nursing, University of North Carolina, Chapel Hill, NC, 27599-7460, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Andersen', 'Affiliation': 'School of Nursing, Thompson Rivers University, Kamloops, British Columbia, V2C 0C8, Canada.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Boström', 'Affiliation': 'Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, SE-104 35, Stockholm, Sweden.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cranley', 'Affiliation': 'Lawrence S Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, M5T 1P8, Canada.'}, {'ForeName': 'Holly J', 'Initials': 'HJ', 'LastName': 'Lanham', 'Affiliation': 'University of Texas Health Science Center San Antonio, University of Texas, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'Weeks', 'Affiliation': 'School of Nursing, Faculty of Health, Dalhousie University, Halifax, Nova Scotia, B3H 4R2, Canada.'}, {'ForeName': 'Greta G', 'Initials': 'GG', 'LastName': 'Cummings', 'Affiliation': 'Faculty of Nursing, University of Alberta, 11405 87 Avenue, Edmonton, Alberta, T6G 1C9, Canada.'}, {'ForeName': 'Jayna M', 'Initials': 'JM', 'LastName': 'Holroyd-Leduc', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, Alberta, T2N 4\u2009N1, Canada.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'Squires', 'Affiliation': 'School of Nursing, Faculty of Health Sciences, University of Ottawa, Ottawa, Ontario, K1H 8\u2009M5, Canada.'}, {'ForeName': 'Adrian S', 'Initials': 'AS', 'LastName': 'Wagg', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, T6G 2P4, Canada.'}, {'ForeName': 'Carole A', 'Initials': 'CA', 'LastName': 'Estabrooks', 'Affiliation': 'Faculty of Nursing, University of Alberta, 11405 87 Avenue, Edmonton, Alberta, T6G 1C9, Canada.'}]",Implementation science : IS,['10.1186/s13012-020-01038-3']
2769,32913174,Does preoperative chemical depilation make any difference in postoperative wound infection?,"Background
Preparation for surgery has traditionally included the removal of body hair from the intended surgical wound site. The effect of this practice on postoperative wound infection is yet to be fully elucidated.
Aims
This study sought to determine if preoperative chemical depilation reduces the risk of surgical site infection (SSI).
Methodology
Two methods of preoperative hair removal: razor shaving and depilatory cream were compared. The eligible patients were randomized into two groups and the presence of postoperative wound infection was evaluated using the Southampton wound grading system. Data were analyzed using SPSS version 21 Chicago-Illinois, statistical significance was inferred at Pvalue ≤ 0.05.
Results
In total 100 patients were analyzed with 20 patients excluded due to co-morbidities and noncompletion of the study. The overall prevalence of SSI was 18.0% (7 (14.0%) and 11 (22.0%) in the depilatory cream and razor shaving groups, respectively). The difference in the rate of SSI was not statistically significant (P = 0.436). Hair was completely removed in 47 (94.0%) compared to 38 (76.0%) patients in the razor shaving group (P = 0.012) while skin injuries were noted in 21 (42.0%) vs 1 (2.0%) patients who had razor shaving and chemical depilation(P = <0.0001), respectively.
Conclusion
There was no significant difference in SSI rates in patients that had preoperative chemical depilation when compared with razor shaving.",2020,There was no significant difference in SSI rates in patients that had preoperative chemical depilation when compared with razor shaving.,['In total 100 patients were analyzed with 20 patients excluded due to co-morbidities and noncompletion of the study'],['preoperative hair removal: razor shaving and depilatory cream'],"['Hair', 'overall prevalence of SSI', 'SSI rates', 'skin injuries', 'rate of SSI']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018504', 'cui_str': 'Epilation'}, {'cui': 'C0336670', 'cui_str': 'Razor'}, {'cui': 'C0518505', 'cui_str': 'Does shave'}, {'cui': 'C0304647', 'cui_str': 'Depilatory agent'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0281980', 'cui_str': 'Injury of integument'}]",100.0,0.0982687,There was no significant difference in SSI rates in patients that had preoperative chemical depilation when compared with razor shaving.,"[{'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Okoli', 'Affiliation': 'Department of Surgery, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Anyanwu', 'Affiliation': 'Department of Surgery, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Emegoakor', 'Affiliation': 'Department of Surgery, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'G U', 'Initials': 'GU', 'LastName': 'Chianakwana', 'Affiliation': 'Department of Surgery, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ihekwoaba', 'Affiliation': 'Department of Surgery, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Ughasoro', 'Affiliation': 'Department of Pediatrics, University of Nigeria Enugu Campus, Enugu, Nigeria.'}, {'ForeName': 'O A', 'Initials': 'OA', 'LastName': 'Egwuonwu', 'Affiliation': 'Department of Surgery, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nzeako', 'Affiliation': 'Department of Surgery, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_149_20']
2770,32903275,The potential effect of instrumentation with different nickel titanium rotary systems on dentinal crack formation-An in vitro study.,"The potential mechanical impact of different rotary systems used for root canal preparation has been a matter of debate for long. The aim of this study was to explore the incidence of dentinal cracks after root canal instrumentation with various rotary systems, in vitro. One hundred and eighty intact lower central incisors were selected and randomly divided into fourteen treatment groups (n = 12/group) and a control group (n = 12). After decoronation, the root canals were instrumented with fourteen different rotary systems (E3, E3 azure, NT2, Hyflex CM, Hyflex EDM, 2Shape, OneCurve, ProTaper Next, ProTaper Gold, WaveOne Gold, Mtwo, Reciproc Blue, TF adaptive, K3XF). All roots were horizontally sectioned at 3, 6, and 9 mm from the apex with a low-speed saw under water-cooling. The slices were then examined under stereomicroscope for dentinal cracks. No cracks were found in the control group. Cracks were found in all treatment groups, predominantly in the 3 mm slices. There was no statistically significant difference in the number of cracks when comparing the different systems to each other at any section level. At 3 mm, however, five of the studied systems, namely K3XF (p = 0.004), Protaper Next (p = 0.001), Reciproc Blue (p<0.001), TF adaptive (p = 0.050), and 2Shape (p = 0.009) presented a significantly higher number of cracks than the control group. Within the limitations of this study, instrumented canals presented dentinal cracks, while uninstrumented ones presented no cracks after sectioning. There seems to be no significant difference among the tested systems regarding crack formation in the instrumented root canal wall. Crack formation occurred irrespective of the motion of the rotary system (rotational or reciprocation). Further studies are needed to clarify the factors that contribute to crack formation in the case of each individual rotary system.",2020,There was no statistically significant difference in the number of cracks when comparing the different systems to each other at any section level.,['One hundred and eighty intact lower central incisors'],['nickel titanium rotary systems'],"['Reciproc Blue (p<0.001), TF adaptive', 'number of cracks', 'Crack formation', 'incidence of dentinal cracks']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040441', 'cui_str': 'Fracture of tooth'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",180.0,0.0185325,There was no statistically significant difference in the number of cracks when comparing the different systems to each other at any section level.,"[{'ForeName': 'Márk', 'Initials': 'M', 'LastName': 'Fráter', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Jakab', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Braunitzer', 'Affiliation': 'dicomLAB Dental Ltd., Szeged, Hungary.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Tóth', 'Affiliation': 'Department of Oral Biology and Experimental Dental Research, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Nagy', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}]",PloS one,['10.1371/journal.pone.0238790']
2771,32904711,Glucose-Dependent Insulinotropic Polypeptide (GIP) Reduces Bone Resorption in Patients With Type 2 Diabetes.,"Context
In healthy individuals, glucose-dependent insulinotropic polypeptide (GIP) enhances insulin secretion and reduces bone resorption by up to 25% estimated by absolute placebo-corrected changes in carboxy-terminal type 1 collagen crosslinks (CTX) during GIP and glucose administration. In patients with type 2 diabetes (T2D), GIP's insulinotropic effect is impaired and effects on bone may be reduced.
Objective
To investigate GIP's effect on bone biomarkers in patients with T2D.
Design
Randomized, double-blinded, crossover study investigating 6 interventions.
Patients
Twelve male patients with T2D.
Interventions
A primed continuous 90-minute GIP infusion (2 pmol/kg/min) or matching placebo (saline) administered at 3 plasma glucose (PG) levels (i.e., paired days with ""insulin-induced hypoglycemia"" (PG lowered to 3 mmol/L), ""fasting hyperglycemia"" (mean PG ~8 mmol/L), or ""aggravated hyperglycemia"" (mean PG ~12 mmol/L).
Main Outcome Measures
Bone biomarkers: CTX, procollagen type 1 N-terminal propeptide (P1NP) and PTH.
Results
On days with insulin-induced hypoglycemia, CTX was suppressed by up to 40 ± 15% during GIP administration compared with 12 ± 11% during placebo infusion ( P < 0.0001). On days with fasting hyperglycemia, CTX was suppressed by up to 36 ± 15% during GIP administration, compared with 0 ± 9% during placebo infusion ( P < 0.0001). On days with aggravated hyperglycemia, CTX was suppressed by up to 47 ± 23% during GIP administration compared with 10 ± 9% during placebo infusion ( P = 0.0005). At all glycemic levels, P1NP and PTH concentrations were similar between paired days after 90 minutes.
Conclusions
Short-term GIP infusions reduce bone resorption by more than one-third (estimated by absolute placebo-corrected CTX reductions) in patients with T2DM, suggesting preserved bone effects of GIP in these patients.
Précis
Short-term GIP infusions reduce the bone resorption marker CTX by one-third in patients with type 2 diabetes independent of glycemic levels.",2020,"Bone biomarkers: CTX, procollagen type 1 N-terminal propeptide (P1NP) and PTH.
","['patients with T2D', 'Patients With Type 2 Diabetes', 'patients with type 2 diabetes (T2D', 'Patients\n\n\nTwelve male patients with T2D.\nInterventions\n\n\nA']","['primed continuous 90-minute GIP infusion (2 pmol/kg/min) or matching placebo (saline) administered at 3 plasma glucose (PG) levels (i.e., paired days with ""insulin-induced hypoglycemia"" (PG lowered to 3 mmol/L), ""fasting hyperglycemia"" (mean PG ~8 mmol/L), or ""aggravated hyperglycemia']","['bone biomarkers', 'Bone Resorption', 'bone resorption marker CTX', 'Glucose-Dependent Insulinotropic Polypeptide (GIP', 'hypoglycemia, CTX', 'bone resorption', 'glycemic levels, P1NP and PTH concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439192', 'cui_str': 'pmol'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C2609269', 'cui_str': 'Fasting hyperglycaemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",12.0,0.365665,"Bone biomarkers: CTX, procollagen type 1 N-terminal propeptide (P1NP) and PTH.
","[{'ForeName': 'Mikkel B', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Asger B', 'Initials': 'AB', 'LastName': 'Lund', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Niklas R', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvaa097']
2772,32917784,A Randomized Trial on the Effect of Phosphate Reduction on Vascular End Points in CKD (IMPROVE-CKD).,"BACKGROUND
Hyperphosphatemia is associated with increased fibroblast growth factor 23 (FGF23), arterial calcification, and cardiovascular mortality. Effects of phosphate-lowering medication on vascular calcification and arterial stiffness in CKD remain uncertain.
METHODS
To assess the effects of non-calcium-based phosphate binders on intermediate cardiovascular markers, we conducted a multicenter, double-blind trial, randomizing 278 participants with stage 3b or 4 CKD and serum phosphate >1.00 mmol/L (3.10 mg/dl) to 500 mg lanthanum carbonate or matched placebo thrice daily for 96 weeks. We analyzed the primary outcome, carotid-femoral pulse wave velocity, using a linear mixed effects model for repeated measures. Secondary outcomes included abdominal aortic calcification and serum and urine markers of mineral metabolism.
RESULTS
A total of 138 participants received lanthanum and 140 received placebo (mean age 63.1 years; 69% male, 64% White). Mean eGFR was 26.6 ml/min per 1.73 m 2 ; 45% of participants had diabetes and 32% had cardiovascular disease. Mean serum phosphate was 1.25 mmol/L (3.87 mg/dl), mean pulse wave velocity was 10.8 m/s, and 81.3% had abdominal aortic calcification at baseline. At 96 weeks, pulse wave velocity did not differ significantly between groups, nor did abdominal aortic calcification, serum phosphate, parathyroid hormone, FGF23, and 24-hour urinary phosphate. Serious adverse events occurred in 63 (46%) participants prescribed lanthanum and 66 (47%) prescribed placebo. Although recruitment to target was not achieved, additional analysis suggested this was unlikely to have significantly affected the principle findings.
CONCLUSIONS
In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo. These findings do not support the role of intestinal phosphate binders to reduce cardiovascular risk in patients with CKD who have normophosphatemia.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER
Australian Clinical Trials Registry, ACTRN12610000650099.",2020,"In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo.","['278 participants with stage 3b or 4 CKD and serum phosphate >1.00 mmol/L (3.10 mg/dl) to 500 mg', '138 participants received', 'patients with CKD who have normophosphatemia', 'mean age 63.1 years; 69% male, 64% White']","['phosphate-lowering medication', 'lanthanum carbonate or matched placebo', 'non-calcium-based phosphate binders', 'lanthanum', 'Phosphate Reduction', 'placebo']","['mean pulse wave velocity', 'abdominal aortic calcification', 'vascular calcification and arterial stiffness', 'pulse wave velocity', 'fibroblast growth factor 23 (FGF23), arterial calcification, and cardiovascular mortality', 'abdominal aortic calcification, serum phosphate, parathyroid hormone, FGF23, and 24-hour urinary phosphate', 'Mean serum phosphate', 'Serious adverse events', 'cardiovascular disease', 'arterial stiffness or aortic calcification', 'cardiovascular risk', 'abdominal aortic calcification and serum and urine markers of mineral metabolism', 'Mean eGFR', 'carotid-femoral pulse wave velocity']","[{'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0023031', 'cui_str': 'Lanthanum'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1096249', 'cui_str': 'Aortic calcification'}, {'cui': 'C0342649', 'cui_str': 'Vascular calcification'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C1168153', 'cui_str': 'Arterial calcification'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",278.0,0.574529,"In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo.","[{'ForeName': 'Nigel D', 'Initials': 'ND', 'LastName': 'Toussaint', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia Nigel.Toussaint@mh.org.au.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Pedagogos', 'Affiliation': 'Department of Medicine, The Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Lioufas', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Grahame J', 'Initials': 'GJ', 'LastName': 'Elder', 'Affiliation': 'School of Medicine, University of Notre Dame, Sydney, New South Wales, Australia.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Pascoe', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Badve', 'Affiliation': 'St. George Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Valks', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Reata Pharmaceuticals, Plano, Texas.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Boudville', 'Affiliation': 'Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Cameron', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash Heart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Katrina L', 'Initials': 'KL', 'LastName': 'Campbell', 'Affiliation': 'Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sylvia S M', 'Initials': 'SSM', 'LastName': 'Chen', 'Affiliation': 'Epworth Healthcare, Melbourne, Victoria, Australia.'}, {'ForeName': 'Randall J', 'Initials': 'RJ', 'LastName': 'Faull', 'Affiliation': 'Department of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Holt', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Jackson', 'Affiliation': 'Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'Concord Repatriation and General Hospital, Concord, New South Wales, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kerr', 'Affiliation': 'Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Kenneth K', 'Initials': 'KK', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Lai-Seong', 'Initials': 'LS', 'LastName': 'Hooi', 'Affiliation': 'Sultanah Aminah Hospital, Johor Bahru, Malaysia.'}, {'ForeName': 'Om', 'Initials': 'O', 'LastName': 'Narayan', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash Heart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kevan R', 'Initials': 'KR', 'LastName': 'Polkinghorne', 'Affiliation': 'Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Pollock', 'Affiliation': 'Kolling Institute, Royal North Shore Hospital, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reidlinger', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Robison', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Smith', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Walker', 'Affiliation': 'Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Angela Yee Moon', 'Initials': 'AYM', 'LastName': 'Wang', 'Affiliation': 'Queen Mary Hospital, University of Hong Kong, Hong Kong.'}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020040411']
2773,32916181,The effects of an exercise training on steroid hormones in preadolescent children - a moderator for enhanced cognition?,"OBJECTIVE
Research demonstrates a variety of cognitive benefits induced by different chronic physiological stressors (e.g. motor vs. cardiovascular exercise training) and acute exercise to affect steroid hormone secretion, the present study aims to investigate 1.) motor vs. cardiovascular exercise training and their impact on salivary Testosterone, Estradiol and Progesterone and 2.) whether alterations in steroid hormones might moderate exercise-induced cognitive benefits.
METHODS
In a randomized control trial, 71 preadolescent children (39 girls) at the age of 9-10 years were randomly assigned to a cardiovascular exercise group (CE), a motor exercise group (ME) as well as a control group (CON) in which students were attending assisted homework. The participants attended their program three times per week, for a total of 10 weeks. Steroid hormones in the saliva, working memory performance and state-trait anxiety levels were determined before and after the intervention.
RESULTS
Statistical analysis showed no chronic changes in hormones through the interventions. Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014). Within the ME, increases of Testosterone from t 1 to t 2 were predicting higher working memory performance post-intervention (β = 0.45, R 2 = 0.16, p = 0.038).
CONCLUSION
Our findings suggest 1.) that motor-exercise-induced cognitive benefits are moderated by changes in Testosterone and 2.) that a 10-week exercise training of moderate intensity and with a motor demanding vs a cardiovascular character does not affect the chronic concentration of salivary Testosterone, Estradiol and Progesterone nor anxiety levels in preadolescent children.",2020,"Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014).","['preadolescent children', '71 preadolescent children (39 girls) at the age of 9-10 years']","['cardiovascular exercise group (CE), a motor exercise group (ME) as well as a control group (CON', 'exercise training', 'motor vs. cardiovascular exercise training']","['salivary Testosterone, Estradiol and Progesterone and 2', 'saliva, working memory performance and state-trait anxiety levels', 'Testosterone', 'steroid hormones', 'chronic concentration of salivary Testosterone, Estradiol and Progesterone nor anxiety levels']","[{'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0301818', 'cui_str': 'Steroid hormone'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",71.0,0.0658097,"Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014).","[{'ForeName': 'Davin P', 'Initials': 'DP', 'LastName': 'Akko', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany; Faculty of Humanities and Social Sciences, University of Hagen, Hagen, Germany. Electronic address: davin-patrick.akko@fernuni-hagen.de.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Koutsandréou', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Murillo-Rodríguez', 'Affiliation': 'Escuela de Medicina, División Ciencias de la Salud, Universidad Anáhuac Mayab Mérida, Mérida, Yucatán, Mexico.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Wegner', 'Affiliation': 'Department of Sport Psychology, Institute of Sports Science, Humboldt University Berlin, Berlin, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Budde', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113168']
2774,32920297,Postprandial factor VII activation does not increase plasma concentrations of prothrombin fragment 1 + 2 in patients with morbid obesity.,"INTRODUCTION
Increased postprandial factor VII activation is observed after high-fat meals, but is not accompanied by thrombin formation in normal weight individuals. Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals. We therefore compared postprandial effects of high-fat meals and low-fat meals on biomarkers of coagulation activation in patients with morbid obesity and investigated whether the response was associated with the gut bacteria composition.
MATERIALS AND METHODS
A controlled cross-over study was conducted in obese patients (15 women, 5 men, mean BMI = 44.1 kg/m 2 ), where high-fat meals (67 E% fat) and low-fat meals (16 E% fat) were served at 8:15 and 10:00 in a random order on two study days within one week. Blood samples were collected at 08:00 (fasting), 12:00, and 14:00 and analysed for triglycerides, activated FVII (FVIIa), TF, FVIIa-antithrombin (FVIIa-AT), prothrombin fragment 1 + 2 (F1+2), and TF pathway inhibitor (TFPI). The gut bacteria composition, measured as gram-negative bacteria and diversity, was analysed in faecal samples.
RESULTS
Triglycerides, FVIIa, and FVIIa-AT increased significantly after high-fat meals, whereas F1 + 2 decreased equally and significantly over time after both meals. There were no significant changes in TF and TFPI over time. The postprandial changes in F1 + 2 and TFPI after high-fat meals were negatively correlated with diversity.
CONCLUSIONS
Increased postprandial FVIIa is not accompanied by thrombin formation four hours after high-fat meals in patients with morbid obesity, possibly due to FVIIa-inhibition by AT.",2020,"Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals.","['patients with morbid obesity', 'obese patients (15 women, 5 men, mean BMI\xa0', 'normal weight individuals']",['high-fat meals and low-fat meals'],"['Triglycerides, FVIIa, and FVIIa-AT', 'triglycerides, activated FVII (FVIIa), TF, FVIIa-antithrombin (FVIIa-AT), prothrombin fragment 1\xa0+\xa02 (F1+2), and TF pathway inhibitor (TFPI', 'Blood samples', 'postprandial changes', 'gut bacteria composition', 'TF and TFPI', 'thrombin formation', 'circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0040048', 'cui_str': 'Thromboplastin'}, {'cui': 'C0072436', 'cui_str': 'Prothrombin fragment 1.2'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]",,0.0190304,"Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals.","[{'ForeName': 'Line Espenhain', 'Initials': 'LE', 'LastName': 'Landgrebe', 'Affiliation': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Denmark; OPEN, Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark. Electronic address: Line.Espenhain.Landgrebe@rsyd.dk.'}, {'ForeName': 'Claus Bogh', 'Initials': 'CB', 'LastName': 'Juhl', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Denmark; Department of Medicine, Section of Endocrinology, University Hospital of Southern Denmark, Esbjerg, Denmark; Steno Diabetes Center Odense, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Denmark; Focused Research Unit for Molecular Diagnostic and Clinical Research, University Hospital of Southern Denmark, Aabenraa, Denmark; Institute of Molecular Medicine, University of Southern Denmark, Denmark.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Moitinho-Silva', 'Affiliation': 'Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany; Department of Dermatology, Venereology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bang', 'Affiliation': 'Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany.'}, {'ForeName': 'Else Marie', 'Initials': 'EM', 'LastName': 'Bladbjerg', 'Affiliation': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Denmark.'}]",Thrombosis research,['10.1016/j.thromres.2020.08.044']
2775,32920492,A randomized-controlled trial of blonanserin and olanzapine as adjunct to antipsychotics in the treatment of patients with schizophrenia and dopamine supersensitivity psychosis: The ROADS study.,"Dopamine supersensitivity psychosis (DSP) is a key factor contributing to the development of antipsychotic treatment-resistant schizophrenia. We examined the efficacy and safety of blonanserin (BNS) and olanzapine (OLZ) as adjuncts to prior antipsychotic treatment in patients with schizophrenia and DSP in a 24-week, multicenter (17 sites), randomized, rater-blinded study with two parallel groups (BNS and OLZ add-on treatments) in patients with schizophrenia and DSP: the ROADS Study. The primary outcome was the change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 24. Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses. The 61 assessed patients were allocated into a BNS group (n = 26) and an OLZ group (n = 29). The PANSS total scores were reduced in both groups (mean ± SD: -14.8 ± 24.0, p = 0.0042; -10.5 ± 12.9, p = 0.0003; respectively) with no significant between-group difference (mean, -4.3, 95 %CI 15.1-6.4, p = 0.42). The BNS group showed significant reductions from week 4; the OLZ group showed significant reductions from week 8. The ESRS scores were reduced in the BNS group and the others were reduced in both groups. The antipsychotic monotherapy rates at the endpoint were 26.3 % (n = 6) for BNS and 23.8 % (n = 5) for OLZ. The concomitant antipsychotic doses were reduced in both groups with good tolerability. Our results suggest that augmentations with BNS and OLZ are antipsychotic treatment options for DSP patients, and BNS may be favorable for DSP based on the relatively quick responses to BNS observed herein.",2020,"Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses.","['patients with schizophrenia and dopamine supersensitivity psychosis', 'Dopamine supersensitivity psychosis (DSP', 'patients with schizophrenia and DSP in a 24-week, multicenter (17 sites', 'patients with schizophrenia and DSP']","['BNS', 'OLZ', 'antipsychotics', 'blonanserin (BNS) and olanzapine (OLZ', 'blonanserin and olanzapine']","['PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses', 'antipsychotic monotherapy rates', 'change in the Positive and Negative Syndrome Scale (PANSS) total score', 'ESRS scores', 'PANSS total scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0287983', 'cui_str': 'blonanserin'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0187611,"Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses.","[{'ForeName': 'Tomihisa', 'Initials': 'T', 'LastName': 'Niitsu', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan. Electronic address: niitsu@chiba-u.jp.'}, {'ForeName': 'Tatsuki', 'Initials': 'T', 'LastName': 'Hata', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Fujita Hospital, Sosa, Chiba, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Nishimoto', 'Affiliation': 'Soshu Hospital, Atsugi, Kanagawa, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Hosoda', 'Affiliation': 'Fujita Hospital, Sosa, Chiba, Japan; Child Psychiatry, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kimura', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Oda', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Mobara Mental Hospital, Mobara, Chiba, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Takase', 'Affiliation': 'Mobara Mental Hospital, Mobara, Chiba, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Seki', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Chiba Hospital, Funabashi, Chiba, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Okehazama Hospital Fujita Kokoro Care Center, Toyoake, Aichi, Japan.'}, {'ForeName': 'Mitsugu', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': 'Asai Hospital, Togane, Chiba, Japan.'}, {'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Kisatazu Hospital, Kisarazu, Chiba, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Katsushikabashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Johmoh Hospital, Maebashi, Gunma, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Sanmaibashi Hospital, Ota, Gunma, Japan.'}, {'ForeName': 'Yukitsugu', 'Initials': 'Y', 'LastName': 'Imamura', 'Affiliation': 'Department of Neuropsychiatry, Asahi General Hospital, Asahi, Chiba, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Yowa Hospital, Tokyo, Japan; Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Goro', 'Initials': 'G', 'LastName': 'Fukami', 'Affiliation': 'Chiba Psychiatric Medical Center, Chiba, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Project Leader Office, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Biostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Sodegaura-Satsukidai Hospital, Sodegaura, Chiba, Japan.'}, {'ForeName': 'Masatomo', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Shiina', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Kanahara', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Iyo', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Child Psychiatry, Chiba University Hospital, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102369']
2776,32945733,Unplanned Cesarean Birth: Can the Quality of Consent Affect Birth Experiences?,"BACKGROUND
Unplanned cesarean birth is associated with high levels of patient dissatisfaction and negative birth experiences, which in turn can negatively impact birth outcomes. Previous research has demonstrated that issues of physician-patient communication, mistrust, fear of the operating room (OR), and loss of control contribute to patient dissatisfaction with unplanned cesarean birth. We hypothesized that altering the nature and structure of the informed consent prior to the surgery might improve patient satisfaction and birth experience. Specifically, we explored whether educating resident physicians in counseling skills could shift the focus of informed consent from a checklist merely informing the patient of the risks, benefits, and alternatives to a discussion that informs the physician of the patient's concerns and fears. By approaching consent in this manner, the goal of informed consent expands beyond autonomy rights to include beneficence as well. Methods: Residents received education to discuss issues of communication, fear, mistrust, and loss of control when seeking consent for an unplanned cesarean birth. Patients were randomized to receive either additional counseling that encouraged a discussion or a standard informed consent for cesarean birth. Participants were interviewed two weeks later and scored their satisfaction using a Likert scale on the four themes: communication, mistrust, fear of OR, and loss of control. Results: Both groups had very high patient satisfaction scores; there was no statistical difference between them. Conclusions: Both groups exhibited significantly higher levels of birth satisfaction than present in prior research. Training residents to discuss these issues while seeking consent for an unplanned cesarean birth may have improved patient satisfaction for all participants in this study. This suggests that educating residents to engage patients in a dialogue during informed consent counseling is more important than a specific script.",2020,Both groups had very high patient satisfaction scores; there was no statistical difference between them. ,[],['additional counseling that encouraged a discussion or a standard informed consent for cesarean birth'],"['birth satisfaction', 'Unplanned Cesarean Birth']",[],"[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",,0.0198502,Both groups had very high patient satisfaction scores; there was no statistical difference between them. ,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Burcher', 'Affiliation': 'Department of Obstetrics and Gynecology, WellSpan York Hospital, York, Pennsylvania, USA.'}, {'ForeName': 'Shazneen', 'Initials': 'S', 'LastName': 'Hushmendy', 'Affiliation': 'Department of Obstetrics and Gynecology, Albany Medical College, Albany, New York, USA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Chan-Mahon', 'Affiliation': 'Department of Obstetrics and Gynecology, Albany Medical College, Albany, New York, USA.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Dasani', 'Affiliation': 'Department of Obstetrics and Gynecology, Albany Medical College, Albany, New York, USA.'}, {'ForeName': 'Jazmine', 'Initials': 'J', 'LastName': 'Gabriel', 'Affiliation': 'Penn State Health, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Crosby', 'Affiliation': 'Department of Obstetrics and Gynecology, Albany Medical College, Albany, New York, USA.'}]",AJOB empirical bioethics,['10.1080/23294515.2020.1817174']
2777,32941345,Effects on Firefighters' Nocturnal Cardiac Autonomic Activity and Sleep Quality of On-Call Nights With and Without Simulated Firefighting Interventions.,"OBJECTIVE
To examine the effects on firefighters' nocturnal cardiac autonomic activity and sleep quality of one on-call night without intervention and one on-call night with intervention.
METHODS
Thirteen firefighters completed three experimental nights: a control night (CON), an on-call night without intervention (0-INTER), an on-call night with one simulated intervention (1-INTER). Sleep parameters were determined from nocturnal heart rate variability (HRV), objective and subjective sleep quality.
RESULTS
Derived parasympathetic HRV indices were higher in CON compared with 0-INTER and 1-INTER (P < 0.05). Subjective sleep quality and total sleep time were decreased in 1-INTER compared with CON and 0-INTER (P < 0.01).
DISCUSSION
These results revealed that for firefighters, being on-call during the night with and without interventions disturbs cardiac autonomic activity. Objective and subjective sleep quality were disrupted when on-call nights were interrupted by simulated firefighting interventions.",2020,"Subjective sleep quality and total sleep time were decreased in 1-INTER compared to CON and 0-INTER (p < 0.01).
",['Thirteen firefighters completed three experimental nights: a'],"['control night (CON), an on-call night without intervention (0-INTER), an on-call night with one simulated intervention (1-INTER', 'CON']","['parasympathetic HRV indices', ""Firefighters' Nocturnal Cardiac Autonomic Activity and Sleep Quality"", 'nocturnal heart rate variability (HRV), objective and subjective sleep quality', 'Subjective sleep quality and total sleep time', 'Objective and subjective sleep quality']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",13.0,0.0137091,"Subjective sleep quality and total sleep time were decreased in 1-INTER compared to CON and 0-INTER (p < 0.01).
","[{'ForeName': 'Philémon', 'Initials': 'P', 'LastName': 'Marcel-Millet', 'Affiliation': 'Laboratory C3S (EA 4660), Department of Sport and Performance, University of Bourgogne-Franche-Comte, Besançon, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Groslambert', 'Affiliation': ''}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Ravier', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000002025']
2778,32948386,Correlation between Post-Procedure Residual Thrombus and Clinical Outcome in Deep Vein Thrombosis Patients Receiving Pharmacomechanical Thrombolysis in a Multicenter Randomized Trial.,"PURPOSE
To evaluate relationships between immediate venographic results and clinical outcomes of pharmacomechanical catheter-directed thrombolysis (PCDT).
MATERIALS AND METHODS
Venograms from 317 patients with acute proximal deep vein thrombosis (DVT) who received PCDT in a multicenter randomized trial were reviewed. Quantitative thrombus resolution was assessed by independent readers using a modified Marder scale. The physician operators recorded their visual assessments of thrombus regression and venous flow. These immediate post-procedure results were correlated with patient outcomes at 1, 12, and 24 months.
RESULTS
PCDT produced substantial thrombus removal (P < .001 for pre-PCDT vs. post-PCDT thrombus scores in all segments). At procedure end, spontaneous venous flow was present in 99% of iliofemoral venous segments and in 89% of femoral-popliteal venous segments. For the overall proximal DVT population, and for the femoral-popliteal DVT subgroup, post-PCDT thrombus volume did not correlate with 1-month or 24-month outcomes. For the iliofemoral DVT subgroup, over 1 and 24 months, symptom severity scores were higher (worse), and venous disease-specific quality of life (QOL) scores were lower (worse) in patients with greater post-PCDT thrombus volume, with the difference reaching statistical significance for the 24-month Villalta post-thrombotic syndrome (PTS) severity score (P = .0098). Post-PCDT thrombus volume did not correlate with 12-month valvular reflux.
CONCLUSIONS
PCDT successfully removes thrombus in acute proximal DVT. However, the residual thrombus burden at procedure end does not correlate with the occurrence of PTS during the subsequent 24 months. In iliofemoral DVT, lower residual thrombus burden correlates with reduced PTS severity and possibly also with improved venous QOL and fewer early symptoms.",2020,"RESULTS
PCDT produced substantial thrombus removal (P < .001 for pre-PCDT vs. post-PCDT thrombus scores in all segments).","['Deep Vein Thrombosis Patients Receiving', 'Venograms from 317 patients with acute proximal deep vein thrombosis (DVT) who received PCDT in a multi-center randomized trial were reviewed']","['Pharmacomechanical Thrombolysis', 'pharmacomechanical catheter-directed thrombolysis (PCDT']","['visual assessments of thrombus regression and venous flow', '24-month Villalta post-thrombotic syndrome (PTS) severity score', 'substantial thrombus removal', 'symptom severity scores', '12-month valvular reflux', 'venous disease-specific quality of life (QOL) scores', 'spontaneous venous flow', 'Quantitative thrombus resolution', 'venous QOL']","[{'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031545', 'cui_str': 'Venography'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0429874', 'cui_str': 'Venous flow'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0277919', 'cui_str': 'Venous stasis syndrome'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0235522', 'cui_str': 'Disorder of vein'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}]",317.0,0.0542837,"RESULTS
PCDT produced substantial thrombus removal (P < .001 for pre-PCDT vs. post-PCDT thrombus scores in all segments).","[{'ForeName': 'Mahmood K', 'Initials': 'MK', 'LastName': 'Razavi', 'Affiliation': ""St. Joseph's Hospital, Orange, California.""}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Salter', 'Affiliation': 'Division of Biostatistics, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Lancia', 'Affiliation': 'Division of Biostatistics, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Kahn', 'Affiliation': 'Department of Medicine, McGill University, Division of Internal Medicine & Center for Clinical Epidemiology, Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'Weinberg', 'Affiliation': 'Vascular Medicine Section, Cardiology Division, Vascular Ultrasound Core Laboratory (VasCore), Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Kearon', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Ezana M', 'Initials': 'EM', 'LastName': 'Azene', 'Affiliation': 'Gundersen Health System, La Crosse, Wisconsin.'}, {'ForeName': 'Nilesh H', 'Initials': 'NH', 'LastName': 'Patel', 'Affiliation': 'Total Vascular Care Centers LLC, Peoria, Arizona.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Vedantham', 'Affiliation': 'Mallinckrodt Institute of Radiology, Washington University in St. Louis, 510 S. Kingshighway Blvd., Box 8131, St. Louis, MO, 63110. Electronic address: vedanthams@wustl.edu.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2020.07.010']
2779,32948387,Double-Needle Lavage for Effective Treatment of Difficult-Aspiration Thyroid Cystic Nodules: A Single-Center Controlled Trial.,"PURPOSE
To explore the safety and efficacy of double-needle lavage (DNL) in the treatment of difficult aspiration thyroid cystic nodules.
MATERIALS AND METHODS
This single-center, prospective, randomized controlled trial was conducted using 100 thyroid cysts from 100 patients who were treated in our hospital from January 2018 to August 2019. These patients were placed into 2 groups; group A including 40 patients treated with single-needle aspiration (SNA), and group B including 60 patients treated with DNL. The safety and efficacy of these 2 aspiration methods were compared.
RESULTS
Ten patients in group A that did not benefit from SNA were transferred to group B. No complication occurred in either group. Notably, DNL showed significantly higher efficacy than SNA. This was evidenced by the higher extraction rate of materials in the capsule (A vs B, 91 ± 6.51% vs 98.45 ± 1.74%, P < .001) and overall nodule volume reduction rate in group B (A vs B, 87.54 ± 7.84% vs 95.62 ± 3.66%, P < .001). In group B, patients who received DNL treatment with 2 needles pointed at the upper and lower extremes of the cystic nodules (B2) exhibited significantly better aspiration effects compared to patients in which the 2 needles were pointed at the same ultrasound plane (B1) (P < .05), especially for patients with maximum diameter of nodules ≥3 cm (P < .01).
CONCLUSIONS
DNL treatment could efficiently and safely replace cystic material from thyroid gland. Moreover, our results indicate that DNL treatment in which 2 needles are pointed at the 2 extremes of cystic nodules yields higher efficacy in patients with maximum diameter of nodules ≥3 cm.",2020,B. No complication occurred in either group.,"['100 thyroid cysts from 100 patients who were treated in our hospital from January 2018 to August 2019', 'Difficult-Aspiration Thyroid Cystic Nodules']","['single-needle aspiration (SNA', 'DNL', 'double-needle lavage (DNL', 'Double-Needle Lavage']","['safety and efficacy', 'overall nodule volume reduction rate', 'complication', 'higher extraction rate of materials', 'aspiration effects']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0162299', 'cui_str': 'Cyst of thyroid'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C4302819', 'cui_str': 'Cystic nodule'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0235062,B. No complication occurred in either group.,"[{'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Xiaoyin', 'Affiliation': 'Department of Tumor Interventional Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, 160# Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ping', 'Affiliation': 'Department of Tumor Interventional Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, 160# Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Bingwei', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, 160# Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Min', 'Affiliation': 'Department of Tumor Interventional Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, 160# Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Department of Tumor Interventional Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, 160# Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Zhai', 'Initials': 'Z', 'LastName': 'Bo', 'Affiliation': 'Department of Tumor Interventional Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, 160# Pujian Road, Shanghai, 200127, China. Electronic address: zhaiboshi@sina.com.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2020.03.005']
2780,32946618,"Expression of HGF, pMet, and pAkt is related to benefit of radiotherapy after breast-conserving surgery: a long-term follow-up of the SweBCG91-RT randomised trial.","Experimental studies suggest that hepatocyte growth factor (HGF) and its transmembrane tyrosine kinase receptor, Met, in part also relying on Akt kinase activity, mediate radioresistance. We investigated the importance of these biomarkers for the risk of ipsilateral breast tumour recurrence (IBTR) after adjuvant radiotherapy (RT) in primary breast cancer. HGF, phosphorylated Met (pMet) and phosphorylated Akt (pAkt) were evaluated immunohistochemically on tissue microarrays from 1004 patients in the SweBCG91-RT trial, which randomly assigned patients to breast-conserving therapy, with or without adjuvant RT. HGF was evaluated in the stroma (HGF str ); pMet in the membrane (pMet mem ); HGF, pMet and pAkt in the cytoplasm (HGF cyt , pMet cyt , pAkt cyt ); and pAkt in the nucleus (pAkt nuc ). The prognostic and treatment predictive effects were evaluated to primary endpoint IBTR as first event during the first 5 years. Patients with tumours expressing low levels of HGF cyt and pMet cyt and high levels of pAkt nuc derived a larger benefit from RT [hazard ratio (HR): 0.11 (0.037-0.30), 0.066 (0.016-0.28) and 0.094 (0.028-0.31), respectively] compared to patients with high expression of HGF cyt and pMet cyt , and low pAkt nuc [HR: 0.36 (0.19-0.67), 0.35 (0.20-0.64) and 0.47 (0.32-0.71), respectively; interaction analyses: P = 0.052, 0.035 and 0.013, respectively]. These differences remained in multivariable analysis when adjusting for patient age, tumour size, histological grade, St Gallen subtype and systemic treatment (interaction analysis, P-values: 0.085, 0.027, and 0.023, respectively). This study suggests that patients with immunohistochemically low HGF cyt , low pMet cyt and high pAkt nuc may derive an increased benefit from RT after breast-conserving surgery concerning the risk of developing IBTR.",2020,"HGF, phosphorylated Met (pMet), and phosphorylated Akt (pAkt) were evaluated immunohistochemically on tissue microarrays from 1,004 patients in the SweBCG91-RT trial, which randomly assigned patients to breast-conserving therapy, with or without adjuvant RT.","['primary breast cancer', 'patients with immunohistochemically low HGF cyt , low pMet cyt , and high pAkt nuc']","['breast-conserving therapy, with or without adjuvant RT', 'radiotherapy', 'adjuvant radiotherapy (RT', 'hepatocyte growth factor (HGF']",['HGF'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0062534', 'cui_str': 'Scatter Factor'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0164786', 'cui_str': 'c-akt Proto-Oncogene Protein'}]","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0062534', 'cui_str': 'Scatter Factor'}]","[{'cui': 'C0062534', 'cui_str': 'Scatter Factor'}]",,0.0359245,"HGF, phosphorylated Met (pMet), and phosphorylated Akt (pAkt) were evaluated immunohistochemically on tissue microarrays from 1,004 patients in the SweBCG91-RT trial, which randomly assigned patients to breast-conserving therapy, with or without adjuvant RT.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sjöström', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Veenstra', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Fredrika', 'Initials': 'F', 'LastName': 'Killander', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Malmström', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Niméus', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Mårten', 'Initials': 'M', 'LastName': 'Fernö', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Stål', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}]",Molecular oncology,['10.1002/1878-0261.12803']
2781,32947390,"Potential hypotensive effects of Umezu polyphenols: a 14-week community-based, double-masked and placebo-controlled trial.","OBJECTIVE
To evaluate blood pressure (BP)-lowering effects of Umezu polyphenols, polyphenols contained in Japanese plums, in a community-based sample by double-masked and placebo-controlled design.
METHODS
Seventy-two Japanese community-dwellers who were interested in prevention or control of their BP (preferably high-normal BP or grade I hypertension) but without antihypertensive medication were randomized into Umezu polyphenols or placebo groups. Each subject took 800 mg/day of Umezu polyphenols or placebo for 12 weeks, followed by a 2-week washout period. Their home and office BP were monitored for 14 weeks in a double-masked manner. We analyzed 56 subjects who met the inclusion criteria.
RESULTS
Home BP increased gradually in both the groups during the intervention period, while diastolic office BP insignificantly decreased in the intervention group. During the washout period, home systolic BP in the morning elevated only in the intervention group.
CONCLUSIONS
The study failed to collect consistent evidence of a clear persistent hypotensive effect of Umezu polyphenols.",2020,"Home BP increased gradually in both the groups during the intervention period, while diastolic office BP insignificantly decreased in the intervention group.","['Seventy-two Japanese community-dwellers who were interested in prevention or control of their BP (preferably high-normal BP or grade', '56 subjects who met the inclusion criteria']","['Umezu polyphenols', 'Umezu polyphenols, polyphenols', 'Umezu polyphenols or placebo']","['diastolic office BP', 'Home BP', 'blood pressure', 'home systolic BP']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",72.0,0.323,"Home BP increased gradually in both the groups during the intervention period, while diastolic office BP insignificantly decreased in the intervention group.","[{'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Takemura', 'Affiliation': 'Department of Hygiene, School of Medicine, Wakayama Medical University, Wakayama.'}, {'ForeName': 'Kouichi', 'Initials': 'K', 'LastName': 'Yoshimasu', 'Affiliation': 'Department of Hygiene, School of Medicine, Wakayama Medical University, Wakayama.'}, {'ForeName': 'Kanami', 'Initials': 'K', 'LastName': 'Tsuno', 'Affiliation': 'Department of Hygiene, School of Medicine, Wakayama Medical University, Wakayama.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Kuroda', 'Affiliation': 'Department of Hygiene, School of Medicine, Wakayama Medical University, Wakayama.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Kishida', 'Affiliation': 'Department of Science and Technology on Food Safety, Faculty of Biology-Oriented Science and Technology, Kindai University, Kinokawa.'}, {'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Mitani', 'Affiliation': 'Research Center for Food and Agriculture, Center for Regional Revitalization, Wakayama University, Wakayama, Wakayama, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Miyashita', 'Affiliation': 'Department of Hygiene, School of Medicine, Wakayama Medical University, Wakayama.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000476']
2782,32947603,Bifidobacterium breve BBG-001 and intestinal barrier function in preterm babies: Exploratory Studies from the PiPS Trial.,"BACKGROUND
Uncertainty remains about the role of probiotics to prevent necrotising enterocolitis (NEC) some of which arises from the variety of probiotic interventions used in different trials, many with no prior evidence of potential efficacy. Mechanistic studies of intestinal barrier function embedded in a large probiotic trial could provide evidence about which properties of probiotics might be important for NEC prevention thus facilitating identification of strains with therapeutic potential.
METHODS
Intestinal permeability, stool microbiota, SCFAs and mucosal inflammation were assessed from the second postnatal week in babies enrolled to a randomised controlled trial of B. breve BBG-001 (the PiPS trial). Results were compared by allocation and by stool colonisation with the probiotic.
RESULTS
Ninety-four preterm babies were recruited across six nested studies. B. breve BBG-001 content was higher by allocation and colonisation; Enterobacteriaceae and acetic acid levels were higher by colonisation. No measure of intestinal barrier function showed differences. The PiPS trial found no evidence of efficacy to reduce NEC.
CONCLUSIONS
That the negative results of the PiPS trial were associated with failure of this probiotic to modify intestinal barrier function supports the possibility that the tests described here have the potential to identify strains to progress to large clinical trials.
IMPACT
Uncertainty about the therapeutic role of probiotics to prevent necrotising enterocolitis is in part due to the wide range of bacterial strains with no previous evidence of efficacy used in clinical trials. We hypothesised that mechanistic studies embedded in a probiotic trial would provide evidence about which properties of probiotics might be important for NEC prevention. The finding that the probiotic strain tested, Bifidobacterium breve BBG-001, showed neither effects on intestinal barrier function nor clinical efficacy supports the possibility that these tests have the potential to identify strains to progress to large clinical trials.",2020,B. breve BBG-001 content was higher by allocation and colonisation; Enterobacteriaceae and acetic acid levels were higher by colonisation.,"['Ninety-four preterm babies', 'Necrotising enterocolitis']",['Bifidobacterium breve'],"['intestinal barrier function', 'Intestinal permeability, stool microbiota, SCFAs and mucosal inflammation', 'acetic acid levels']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infants'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}]","[{'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",94.0,0.042855,B. breve BBG-001 content was higher by allocation and colonisation; Enterobacteriaceae and acetic acid levels were higher by colonisation.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fleming', 'Affiliation': 'Homerton University Hospital, NHS Foundation Trust, London, UK. Paul.fleming@qmul.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wilks', 'Affiliation': 'Department of Infection, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Eaton', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Panton', 'Affiliation': 'Blizard Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hutchinson', 'Affiliation': 'Centre for Genomics and Child Health, Queen Mary University of London, London, UK.'}, {'ForeName': 'Abena', 'Initials': 'A', 'LastName': 'Akyempon', 'Affiliation': 'Homerton University Hospital, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Hardy', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Millar', 'Affiliation': 'Department of Infection, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Costeloe', 'Affiliation': 'Homerton University Hospital, NHS Foundation Trust, London, UK.'}]",Pediatric research,['10.1038/s41390-020-01135-5']
2783,32903140,Age Dependency of the Prognostic Impact of Tumor Genomics in Localized Resectable MYCN -Nonamplified Neuroblastomas. Report From the SIOPEN Biology Group on the LNESG Trials and a COG Validation Group.,"PURPOSE
For localized, resectable neuroblastoma without MYCN amplification, surgery only is recommended even if incomplete. However, it is not known whether the genomic background of these tumors may influence outcome.
PATIENTS AND METHODS
Diagnostic samples were obtained from 317 tumors, International Neuroblastoma Staging System stages 1/2A/2B, from 3 cohorts: Localized Neuroblastoma European Study Group I/II and Children's Oncology Group. Genomic data were analyzed using multi- and pangenomic techniques and fluorescence in-situ hybridization in 2 age groups (cutoff age, 18 months) and were quality controlled by the International Society of Pediatric Oncology European Neuroblastoma (SIOPEN) Biology Group.
RESULTS
Patients with stage 1 tumors had an excellent outcome (5-year event-free survival [EFS] ± standard deviation [SD], 95% ± 2%; 5-year overall survival [OS], 99% ± 1%). In contrast, patients with stage 2 tumors had a reduced EFS in both age groups (5-year EFS ± SD, 84% ± 3% in patients < 18 months of age and 75% ± 7% in patients ≥ 18 months of age). However, OS was significantly decreased only in the latter group (5-year OS ± SD in < 18months and ≥ 18months, 96% ± 2% and 81% ± 7%, respectively; P = .001). In < 18months, relapses occurred independent of segmental chromosome aberrations (SCAs); only 1p loss decreased EFS (5-year EFS ± SD in patients 1p loss and no 1p loss, 62% ± 13% and 87% ± 3%, respectively; P = .019) but not OS (5-year OS ± SD, 92% ± 8% and 97% ± 2%, respectively). In patients ≥ 18 months, only SCAs led to relapse and death, with 11q loss as the strongest marker (11q loss and no 11q loss: 5-year EFS ± SD, 48% ± 16% and 85% ± 7%, P = .033; 5-year OS ± SD, 46% ± 22% and 92% ± 6%, P = .038).
CONCLUSION
Genomic aberrations of resectable non- MYCN- amplified stage 2 neuroblastomas have a distinct age-dependent prognostic impact. Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months. In older patients with SCA, a randomized trial of postoperative chemotherapy compared with observation alone may be indicated.",2020,"Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months.","['older patients with SCA', 'Diagnostic samples were obtained from 317 tumors, International Neuroblastoma Staging System stages 1/2A/2B, from 3 cohorts']",['postoperative chemotherapy'],"['excellent outcome (5-year event-free survival [EFS] ± standard deviation [SD', 'EFS (5-year EFS ± SD', '5-year overall survival [OS', 'OS', 'relapse and death']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]","[{'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0953821,"Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months.","[{'ForeName': 'Inge M', 'Initials': 'IM', 'LastName': 'Ambros', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Gian-Paolo', 'Initials': 'GP', 'LastName': 'Tonini', 'Affiliation': 'Paediatric Research Institute, Fondazione Città della Speranza, Neuroblastoma Laboratory, Padua, Italy.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Pötschger', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Gross', 'Affiliation': 'Pediatric Oncology Research, Department of Pediatrics, University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Mosseri', 'Affiliation': 'Service de Biostatistiques, Institut Curie, Paris, France.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Beiske', 'Affiliation': 'Department of Pathology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Berbegall', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bénard', 'Affiliation': 'Département de Biologie et de Pathologie Médicales, Service de Pathologie Moléculaire, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bown', 'Affiliation': 'Northern Genetics Service, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Huib', 'Initials': 'H', 'LastName': 'Caron', 'Affiliation': ""Department of Pediatric Oncology, Emma Children's Hospital, Academic Medical Center, Amsterdam, the Netherlands.""}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Combaret', 'Affiliation': 'Centre Léon Bérard, Laboratoire de Recherche Translationnelle, Lyon, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Couturier', 'Affiliation': 'Unité de Génétique Somatique et Cytogénétique, Institut Curie, Paris, France.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Defferrari', 'Affiliation': 'Department of Pathology, Istituto G. Gaslini, Genoa, Italy.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Delattre', 'Affiliation': 'INSERM U830, Laboratoire de Génétique et Biologie des Cancers, Paris, France.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Jeison', 'Affiliation': ""Ca-Cytogenetic Laboratory, Pediatric Hematology Oncology Department, Schneider Children's Medical Center of Israel, Petah Tikvah, Israel.""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Kogner', 'Affiliation': ""Childhood Cancer Research Unit, Karolinska Institutet, Astrid Lindgren Children's Hospital, Stockholm, Sweden.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lunec', 'Affiliation': 'Biosciences Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Marques', 'Affiliation': 'Centro de Genética Humana, Instituto Nacional de Saude doutor Ricardo Jorge, Lisbon, Portugal.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Martinsson', 'Affiliation': 'Department of Clinical Genetics, Institute of Biomedicine, University of Gothenburg, Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Mazzocco', 'Affiliation': 'Department of Pathology, Istituto G. Gaslini, Genoa, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Noguera', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Schleiermacher', 'Affiliation': 'INSERM U830, Laboratoire de Génétique et Biologie des Cancers, Paris, France.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Valent', 'Affiliation': 'Département de Biologie et de Pathologie Médicales, Service de Pathologie Moléculaire, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Van Roy', 'Affiliation': 'Center for Medical Genetics, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Villamon', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Dasa', 'Initials': 'D', 'LastName': 'Janousek', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Pribill', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Glogova', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Attiyeh', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hogarty', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Tom F', 'Initials': 'TF', 'LastName': 'Monclair', 'Affiliation': 'Section for Paediatric Surgery, Division of Surgery, Rikshospitalet University Hospital, Oslo, Norway.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Holmes', 'Affiliation': ""Department of Paediatric Surgery, St George's Hospital, London, UK.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Valteau-Couanet', 'Affiliation': ""Département de Cancérologie de l'Enfant et de l'Adolescent, Gustave Roussy, Villejuif, France.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Castel', 'Affiliation': 'Unidad de Oncologia Pediatrica Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Tweddle', 'Affiliation': 'Wolfson Childhood Cancer Research Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': ""Seattle Children's Hospital and University of Washington School of Medicine, Seattle, WA.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Cohn', 'Affiliation': 'Department of Pediatrics, The University of Chicago, Chicago, IL.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ladenstein', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Beck-Popovic', 'Affiliation': 'Pediatric Hematology Oncology Unit, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'De Bernardi', 'Affiliation': ""Department of Paediatric Haematology and Oncology, Giannina Gaslini Children's Hospital, Genova, Italy.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Michon', 'Affiliation': 'Département de Pédiatrie, Institut Curie, Paris, France.'}, {'ForeName': 'Andrew D J', 'Initials': 'ADJ', 'LastName': 'Pearson', 'Affiliation': 'Institute of Cancer Research, Royal Marsden Hospital, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Ambros', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02132']
2784,32918391,A Laboratory-Based Study of the Priming Effects of Food Cues and Stress on Hunger and Food Intake in Individuals with Obesity.,"OBJECTIVE
This study aimed to assess the effects of exposures to food cues and stress on hunger and food intake and examine whether cue responses differ by weight status.
METHODS
In a laboratory-based experimental study, participants (n = 138) were exposed to stress, neutral, and food cues delivered using an individualized script-driven imagery task on three separate days. After each cue exposure, participants ate high- and low-calorie snack foods ad libitum (Food Snack Test). Hunger was measured by visual analog scales.
RESULTS
Food cues elicited significantly greater increases in hunger compared with neutral and stress stimuli. Cue-induced hunger did not differ by weight status. Participants consumed a similar number of total calories across stimuli. In response to food cue provocation, participants with obesity consumed [mean (SE)] 81.0% (4.0%) of calories from high-calorie foods, which was significantly greater than participants with normal weight (63.5% [3.6%]; P = 0.001). After the stress cue, participants with obesity consumed 81.4% (4.0%) of calories from high-calorie foods, which was significantly more than participants with normal weight (70.2% [3.6%]; P = 0.04). Energy intake from high-calorie foods did not differ by weight status after the neutral cue.
CONCLUSIONS
Among individuals with obesity, exposure to food and stress cues shifted consumption to high-calorie snack foods within a well-controlled experimental setting.",2020,Cue-induced hunger did not differ by weight status.,"['participants (n\u2009=\u2009138', 'Individuals with Obesity']","['Food Cues and Stress', 'stress, neutral, and food cues delivered using an individualized script-driven imagery task']","['Cue-induced hunger', 'Hunger', 'weight status', 'hunger compared with neutral and stress stimuli', 'Hunger and Food Intake', 'normal weight']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}]",138.0,0.0895217,Cue-induced hunger did not differ by weight status.,"[{'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Biobehavioral Health Sciences, University of Pennsylvania School of Nursing, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nia', 'Initials': 'N', 'LastName': 'Fogelman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hart', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Grilo', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22952']
2785,32920228,"The effect of pain neurophysiology education on healthcare students' knowledge, attitudes and behaviours towards pain: A mixed-methods randomised controlled trial.","OBJECTIVE
1) To investigate the effects of a brief pain neuroscience education (PNE) lecture on multi-disciplinary healthcare students' knowledge, attitudes and behaviours towards people with pain post intervention and at 6-months follow-up, 2) To explore students' perceptions of PNE.
DESIGN
Mixed-methods randomized controlled trial.
SETTING
UK university.
PARTICIPANTS
Thirty-seven students (30♀, mean age 30 years) from six healthcare disciplines.
INTERVENTION
70-min PNE lecture (intervention group) or a 70-min control education.
MAIN OUTCOME MEASURES
1) Knowledge: The Revised Pain Neurophysiology Quiz (RPNQ); 2) Attitudes: Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS); 3) Behaviours: A case vignette to assess clinical recommendations; and 4) Thematic analysis of semi-structured interviews (n = 12).
RESULTS
The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860). Greater improvements in attitudes for the intervention group were seen post-intervention [-10.4 (-16.3, -4.6), P < 0.001] and at 6-months [-5.8 (-11.5, -0.2), P < 0.044]. There was no difference in behaviours between groups. Thematic analysis identified increased patient empathy, partial and patchy reconceptualisation of pain and increased confidence in recommending an active management programme following PNE.
CONCLUSION
This study adds to existing knowledge by demonstrating that a 70-min PNE lecture can have a short-term effect on knowledge and positively shift attitudes towards people with pain in the short and medium-term. It also resulted in some students' reconceptualisation of pain, increased empathy, and confidence to recommend activity. The effect of PNE on clinical behaviours was unclear.",2020,"The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860).","['UK university', 'healthcare students', 'Knowledge', 'Attitudes', 'Thirty-seven students (30♀, mean age 30 years) from six healthcare disciplines']","['pain neurophysiology education', 'pain neuroscience education (PNE) lecture', '70-min PNE lecture (intervention group) or a 70-min control education', 'PNE']","['knowledge', 'patient empathy, partial and patchy reconceptualisation of pain', ""Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS"", 'knowledge, attitudes and behaviours towards pain', 'pain, increased empathy, and confidence to recommend activity']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027901', 'cui_str': 'Neurophysiology'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3489398', 'cui_str': 'Peripheral neuroepithelioma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205413', 'cui_str': 'Patchy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.210237,"The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860).","[{'ForeName': 'Jagjit', 'Initials': 'J', 'LastName': 'Mankelow', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom. Electronic address: j.mankelow@tees.ac.uk.'}, {'ForeName': 'Cormac', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Taylor', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102249']
2786,32920242,Comparing the clinical impact of pancreatic cyst surveillance programs: A trial of the ECOG-ACRIN cancer research group (EA2185).,"BACKGROUND
The optimal surveillance strategy for pancreatic cysts, which occur in up to 20% of the adult population, is ill defined. The risk of malignant degeneration of these cysts is low, however the morbidity and mortality associated with pancreatic cancer are high. Two clinical surveillance guidelines are in regular use. Both the Fukuoka and American Gastroenterological Association (AGA) guidelines rely on radiographic and endoscopic imaging. They differ primarily in their recommended frequencies of interval surveillance imaging. While evidence driven clinical guidelines should promote higher quality care, competing guidelines on the same topic may provide discordant recommendations and potential reduction in the quality and/or value of care.
OBJECTIVES
The primary objective is to compare the clinical effectiveness of the two surveillance guidelines to identify patients most likely to benefit from pancreatic resection. Secondary objectives include comparison of resource utilization, patient reported outcomes, incidental findings are other clinical outcomes.
METHODS
4606 asymptomatic patients with newly identified pancreatic cysts ≥1 cm in diameter will be randomized 1:1 to high intensity (Fukuoka) or low intensity (AGA) surveillance. All participants will be followed prospectively for 5 years.
CONCLUSION
Differing guidelines confuse providers, patients and policymakers. This large, prospective, randomized trial will compare the clinical effectiveness and resource allocation requirements of two guidelines addressing a common clinical entity. CLINICALTRIALS.
GOV IDENTIFIER
NCT04239573.",2020,"METHODS
4606 asymptomatic patients with newly identified pancreatic cysts ≥1 cm in diameter will be randomized 1:1 to high intensity (Fukuoka) or low intensity (AGA) surveillance.","['4606 asymptomatic patients with newly identified pancreatic cysts ≥1\u202fcm in diameter', 'All participants will be followed prospectively for 5\u202fyears']",['high intensity (Fukuoka) or low intensity (AGA) surveillance'],"['comparison of resource utilization, patient reported outcomes, incidental findings are other clinical outcomes']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0030283', 'cui_str': 'Cyst of pancreas'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0743997', 'cui_str': 'Incidental Findings'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",4606.0,0.104339,"METHODS
4606 asymptomatic patients with newly identified pancreatic cysts ≥1 cm in diameter will be randomized 1:1 to high intensity (Fukuoka) or low intensity (AGA) surveillance.","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Weinberg', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States of America. Electronic address: David.weinberg@fccc.edu.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Gatsonis', 'Affiliation': 'Department of Biostatistics and Center for Statistical Sciences, Brown University School of Public Health, Providence, RI, United States of America.'}, {'ForeName': 'Herbert J', 'Initials': 'HJ', 'LastName': 'Zeh', 'Affiliation': 'UT Southwestern, Simmons Cancer Center, Dallas, TX, United States of America.'}, {'ForeName': 'Ruth C', 'Initials': 'RC', 'LastName': 'Carlos', 'Affiliation': 'University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'University of Pennsylvania-Abramson Cancer Center, Philadelphia, PA, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106144']
2787,32928709,"Pharmacodynamic relationship between PCSK9, alirocumab, and LDL-C lowering in the ODYSSEY CHOICE I trial.","BACKGROUND
The ODYSSEY CHOICE I study (NCT01926782) evaluated alirocumab 300 mg every 4 weeks (Q4W) in patients with hypercholesterolemia receiving maximally tolerated statin or no statin.
OBJECTIVE
The objective of the study was to assess the relationship between alirocumab, proprotein convertase subtilisin/kexin type 9 (PCSK9), and low-density lipoprotein cholesterol (LDL-C) concentrations with the CHOICE I alirocumab dosing regimen.
METHODS
This analysis included 803 patients (547 statin-treated, 256 without statin) who were randomized to alirocumab 300 mg Q4W, alirocumab 75 mg every 2 weeks (Q2W), or placebo. 300 mg Q4W and 75 mg Q2W doses were adjusted to 150 mg Q2W at Week 12 if Week 8 LDL-C was >70 or >100 mg/dL, depending on cardiovascular risk, or if LDL-C reduction was <30% from baseline.
RESULTS
Most patients remained on 300 mg Q4W without dose adjustment as they achieved study-defined LDL-C goals at Week 8 (statin-treated: 80.7%; no statin: 85.3%). LDL-C was reduced by 60.5%-71.9% over Weeks 20-24 in patients on 300 mg Q4W and 57.2%-63.0% in patients with dose adjustment from 300 mg Q4W to 150 mg Q2W. Statin-treated patients had higher cardiovascular risk as well as higher free PCSK9 and lower alirocumab concentrations (vs no statin), suggesting increased target-mediated clearance. Regardless of statin status, the most common adverse events in alirocumab-treated patients were injection-site reaction and headache.
CONCLUSIONS
Data provide further insight on alirocumab's mode of action in terms of relationship between alirocumab, PCSK9, and LDL-C, and disease severity, and support the use of alirocumab 300 mg Q4W as an efficacious dosing regimen for clinically meaningful LDL-C reductions.",2020,"LDL-C was reduced by 60.5%-71.9% over Weeks 20-24 in patients on 300 mg Q4W and 57.2%-63.0% in patients with dose adjustment from 300 mg Q4W to 150 mg Q2W. Statin-treated patients had higher cardiovascular risk as well as higher free PCSK9 and lower alirocumab concentrations (vs no statin), suggesting increased target-mediated clearance.","['patients with hypercholesterolemia receiving maximally tolerated statin or no statin', '803 patients (547 statin-treated, 256 without statin']","['alirocumab', 'alirocumab 300\xa0mg Q4W, alirocumab 75\xa0mg every 2\xa0weeks (Q2W), or placebo']","['low-density lipoprotein cholesterol (LDL-C) concentrations', 'cardiovascular risk', 'free PCSK9 and lower alirocumab concentrations', 'target-mediated clearance', 'LDL-C', 'Pharmacodynamic relationship between PCSK9, alirocumab, and LDL-C lowering']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]",803.0,0.168661,"LDL-C was reduced by 60.5%-71.9% over Weeks 20-24 in patients on 300 mg Q4W and 57.2%-63.0% in patients with dose adjustment from 300 mg Q4W to 150 mg Q2W. Statin-treated patients had higher cardiovascular risk as well as higher free PCSK9 and lower alirocumab concentrations (vs no statin), suggesting increased target-mediated clearance.","[{'ForeName': 'Eli M', 'Initials': 'EM', 'LastName': 'Roth', 'Affiliation': 'The Sterling Research Group, Cincinnati, OH, USA. Electronic address: eroth@sterlingresearch.org.'}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': 'Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': 'Harvard Clinical Research Institute, Boston, MA, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Farnier', 'Affiliation': 'Lipid Clinic, Point Médical and Department of Cardiology, CHU Dijon-Bourgogne, Dijon, France.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'McKenney', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'A Thomas', 'Initials': 'AT', 'LastName': 'DiCioccio', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Brunet', 'Affiliation': 'Sanofi, Clinical Development, R&D, Montpellier, France.'}, {'ForeName': 'Garen', 'Initials': 'G', 'LastName': 'Manvelian', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sasiela', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Baccara-Dinet', 'Affiliation': 'Sanofi, Clinical Development, R&D, Montpellier, France.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Basking Ridge, NJ, USA.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Robinson', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2020.07.009']
2788,32928788,Effect of CPAP on cardiovascular events in minimally symptomatic OSA: long-term follow-up of the MOSAIC randomised controlled trial.,"The effect of continuous positive airway pressure (CPAP) on cardiovascular events is uncertain in minimally symptomatic obstructive sleep apnoea. Previous 2-year follow-up data from the Multicentre Obstructive Sleep Apnoea Intervention Cardiovascular (MOSAIC) trial showed a marginal reduction in cardiovascular events with CPAP therapy. We now present long-term MOSAIC study follow-up data. Median (first quartile, third quartile) follow-up was 5.0 (2.2, 5.0) and 3.7 (1.5, 5.0) years for CPAP and standard care, respectively. Compared to standard care, CPAP had no statistically significant effect on the risk of cardiovascular events (HR=0.83, p=0.54, 95% CI 0.46-1.51).",2020,"Compared to standard care, CPAP had no statistically significant effect on the risk of cardiovascular events (HR=0.83, p=0.54, 95% CI 0.46-1.51).","['minimally symptomatic OSA', 'minimally symptomatic obstructive sleep apnoea']","['CPAP', 'continuous positive airway pressure (CPAP', 'CPAP therapy']","['risk of cardiovascular events', 'cardiovascular events']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.0619029,"Compared to standard care, CPAP had no statistically significant effect on the risk of cardiovascular events (HR=0.83, p=0.54, 95% CI 0.46-1.51).","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Tang', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Milton Keynes University Hospital, Milton Keynes, UK.'}, {'ForeName': 'Chris D', 'Initials': 'CD', 'LastName': 'Turnbull', 'Affiliation': 'Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire, UK christopher.turnbull@ouh.nhs.uk.'}, {'ForeName': 'Dushendree', 'Initials': 'D', 'LastName': 'Sen', 'Affiliation': 'Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Craig', 'Affiliation': 'Liverpool Sleep and Ventilation Centre, University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Kohler', 'Affiliation': 'Centre for Interdisciplinary Sleep Research, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Stradling', 'Affiliation': 'NIHR Biomedical Research Centre Oxford, University of Oxford, Oxford, Oxfordshire, UK.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000742']
2789,32929540,Risk factors for bisphosphonate-associated osteonecrosis of the jaw in the prospective randomized trial of adjuvant bisphosphonates for early-stage breast cancer (SWOG 0307).,"PURPOSE
Bisphosphonates reduce bone metastases in postmenopausal women with early-stage breast cancer but carry the risk of bisphosphonate-related osteonecrosis of the jaw (BRONJ). We describe risk factors for BRONJ and compare BRONJ provoked by infection or trauma with spontaneous lesions, which carry a better prognosis.
METHODS
SWOG 0307 randomized women with stage I-III breast cancer to receive zoledronic acid (ZA), clodronate (CL), or ibandronate (IB) for 3 years, implemented BRONJ prevention guidelines, and collected information about dental health and development of BRONJ. All statistical tests were two-sided.
RESULTS
Of 6018 women, 48 developed BRONJ. Infection was present in 21 (43.8%). Median time to BRONJ was 2.1 years for ZA, 2.0 years for IB, and 3.4 years for clodronate (p = 0.04). BRONJ was associated with bisphosphonate type (28/2231 (1.26%) for ZA, 8/2235 (0.36%) for CL, 12/1552 (0.77%) for IB), dental calculus (OR 2.03), gingivitis (OR 2.11), moderate/severe periodontal disease (OR 2.87), and periodontitis > 4 mm (OR 2.20) (p < 0.05). Of 57 lesions, BRONJ occurred spontaneously in 20 (35.1%) and was provoked by dental extraction in 20 (35.1%), periodontal disease in 14 (24.6%), denture trauma in 6 (10.5%), and dental surgery in 2 (3.5%). Spontaneous BRONJ occurred more frequently at the mylohyoid ridge. There were no differences in dental disease, infection, or bisphosphonate type between spontaneous and provoked BRONJ.
CONCLUSION
ZA and worse dental health were associated with increased incidence of BRONJ, with a trend toward additive risk when combined. BRONJ incidence was lower than in similar studies, with prevention strategies likely linked to this.
CLINICAL TRIAL NUMBER
NCT00127205 REGISTRATION DATE: July 2005.",2020,"BRONJ was associated with bisphosphonate type (28/2231 (1.26%) for ZA, 8/2235 (0.36%) for CL, 12/1552 (0.77%) for IB), dental calculus (OR 2.03), gingivitis (OR 2.11), moderate/severe periodontal disease (OR 2.87), and periodontitis > 4 mm (OR 2.20) (p < 0.05).","['SWOG 0307 randomized women with stage I-III breast cancer to receive', '6018 women, 48 developed BRONJ', 'early-stage breast cancer (SWOG 0307', 'postmenopausal women with early-stage breast cancer']","['zoledronic acid (ZA), clodronate (CL), or ibandronate (IB', 'Bisphosphonates', 'clodronate', 'bisphosphonate', 'adjuvant bisphosphonates']","['Median time to BRONJ', 'gingivitis', 'dental disease, infection, or bisphosphonate type between spontaneous and provoked BRONJ', 'dental calculus', 'Infection', 'moderate/severe periodontal disease', 'denture trauma', 'periodontal disease']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C3178777', 'cui_str': 'Osteonecrosis of jaw due to bisphosphonate'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0162357', 'cui_str': 'Clodronate'}, {'cui': 'C0379199', 'cui_str': 'Ibandronate'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3178777', 'cui_str': 'Osteonecrosis of jaw due to bisphosphonate'}, {'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}, {'cui': 'C1704330', 'cui_str': 'Disorder of teeth AND/OR supporting structures'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0011330', 'cui_str': 'Dental calculus'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]",6018.0,0.0975579,"BRONJ was associated with bisphosphonate type (28/2231 (1.26%) for ZA, 8/2235 (0.36%) for CL, 12/1552 (0.77%) for IB), dental calculus (OR 2.03), gingivitis (OR 2.11), moderate/severe periodontal disease (OR 2.87), and periodontitis > 4 mm (OR 2.20) (p < 0.05).","[{'ForeName': 'Darya A', 'Initials': 'DA', 'LastName': 'Kizub', 'Affiliation': 'The Everett Clinic, Everett, WA, USA. daryakizub@gmail.com.'}, {'ForeName': 'Jieling', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'SWOG Statistical Center, Seattle, WA, USA.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Schubert', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Alexander H G', 'Initials': 'AHG', 'LastName': 'Paterson', 'Affiliation': 'Tom Baker Cancer Center, Calgary, Alberta, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Dees', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Ingle', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Carla I', 'Initials': 'CI', 'LastName': 'Falkson', 'Affiliation': 'Wilmot Cancer Center at the University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Barlow', 'Affiliation': 'SWOG Statistical Center, Seattle, WA, USA.'}, {'ForeName': 'Gabriel N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'University of Washington School of Medicine, Seattle, WA, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05748-8']
2790,32925345,Incidence of and Factors Associated With Prolonged and Persistent Postoperative Opioid Use in Children 0-18 Years of Age.,"BACKGROUND
Long-term opioid use has negative health care consequences. Opioid-naïve adults are at risk for prolonged and persistent opioid use after surgery. While these outcomes have been examined in some adolescent and teenage populations, little is known about the risk of prolonged and persistent postoperative opioid use after common surgeries compared to children who do not undergo surgery and factors associated with these issues among pediatric surgical patients of all ages.
METHODS
Using a national administrative claims database, we identified 175,878 surgical visits by opioid-naïve children aged ≤18 years who underwent ≥1 of the 20 most common surgeries from each of 4 age groups between December 31, 2002, and December 30, 2017, and who filled a perioperative opioid prescription 30 days before to 14 days after surgery. Prolonged opioid use after surgery (filling ≥1 opioid prescription 90-180 days after surgery) was compared to a reference sample of 1,354,909 nonsurgical patients randomly assigned a false ""surgery"" date. Multivariable logistic regression models were used to estimate the association of surgical procedures and 22 other variables of interest with prolonged opioid use and persistent postoperative opioid use (filling ≥60 days' supply of opioids 90-365 days after surgery) for each age group.
RESULTS
Prolonged opioid use after surgery occurred in 0.77%, 0.76%, 1.00%, and 3.80% of surgical patients ages 0-<2, 2-<6, 6-<12, and 12-18, respectively. It was significantly more common in surgical patients than in nonsurgical patients (ages 0-<2: odds ratio [OR] = 4.6 [95% confidence interval (CI), 3.7-5.6]; ages 2-<6: OR = 2.5 [95% CI, 2.1-2.8]; ages 6-<12: OR = 2.1 [95% CI, 1.9-2.4]; and ages 12-18: OR = 1.8 [95% CI, 1.7-1.9]). In the multivariable models for ages 0-<12 years, few surgical procedures and none of the other variables of interest were associated with prolonged opioid use. In the models for ages 12-18 years, 10 surgical procedures and 5 other variables of interest were associated with prolonged opioid use. Persistent postoperative opioid use occurred in <0.1% of patients in all age groups.
CONCLUSIONS
Some patient characteristics and surgeries are positively and negatively associated with prolonged opioid use in opioid-naïve children of all ages, but persistent opioid use is rare. Specific pediatric subpopulations (eg, older patients with a history of mood/personality disorder or chronic pain) may be at markedly higher risk.",2020,"Some patient characteristics and surgeries are positively and negatively associated with prolonged opioid use in opioid-naïve children of all ages, but persistent opioid use is rare.","['Specific pediatric subpopulations (eg, older patients with a history of mood/personality disorder or chronic pain', 'pediatric surgical patients of all ages', '175,878 surgical visits by opioid-naïve children aged ≤18 years who underwent ≥1 of the 20 most common surgeries from each of 4 age groups between December 31, 2002, and December 30, 2017, and who filled a perioperative opioid prescription 30 days before to 14 days after surgery', 'Children 0-18 Years of Age']",[],['Persistent postoperative opioid use'],"[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0031212', 'cui_str': 'Personality disorder'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",[],"[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0613172,"Some patient characteristics and surgeries are positively and negatively associated with prolonged opioid use in opioid-naïve children of all ages, but persistent opioid use is rare.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ward', 'Affiliation': 'From the Departments of Electrical Engineering.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'De Souza', 'Affiliation': 'Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'From the Departments of Electrical Engineering.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Sun', 'Affiliation': 'Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Bambos', 'Affiliation': 'From the Departments of Electrical Engineering.'}, {'ForeName': 'T Anthony', 'Initials': 'TA', 'LastName': 'Anderson', 'Affiliation': 'Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004823']
2791,32927269,The effect of remote patient monitoring on the primary care clinic visit frequency among adults with type 2 diabetes.,"AIMS
Healthcare organizations are increasingly using technology to assist in diabetes management based on telemedicine's proven ability to improve glycemic regulation, decrease cost, and overcome barriers to effective healthcare. Nevertheless, it remains unclear how telemedicine intersects with primary care. We aim to measure the impact of a remote monitoring program for diabetes on primary care delivery through analysis of primary care office visit frequency.
METHODS
Patients eligible to participate in our institution's remote diabetes monitoring program were identified and classified as enrolled or not enrolled (i.e. ""usual care""). The number of scheduled and completed primary care office visits in the 12 months prior to and after the index date were measured for both groups. The index date was the enrollment date or, for the patients who received usual care, the next available enrollment session after eligibility screen. Two-sample t-tests were used to examine the change in frequency of office visits prior to and after enrollment for participants, as well as the difference in visit frequency between enrolled patients versus patients receiving usual care.
RESULTS
There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth. Furthermore, there was no difference in the number of scheduled or completed primary care visits between patients enrolled in telehealth versus those receiving usual care.
CONCLUSION
Participation in telehealth has been shown to be associated with significant HbA1c reductions in prior work, yet our data suggest that remote monitoring is not associated with a change in primary care office visit frequency. This suggests that telehealth may improve diabetes management independently of primary care visits.",2020,There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth.,"['adults with type 2 diabetes', 'Patients eligible to participate in our institution\'s remote diabetes monitoring program were identified and classified as enrolled or not enrolled (i.e. ""usual care']","['remote monitoring program', 'remote patient monitoring']",['number of scheduled or completed primary care clinic visits'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0422587', 'cui_str': 'Diabetes monitoring check done'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]",,0.0160126,There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth.,"[{'ForeName': 'Morgan Hampton', 'Initials': 'MH', 'LastName': 'Randall', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Zachary Merle', 'Initials': 'ZM', 'LastName': 'Haulsee', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA; Section of Health Systems Research and Policy, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA; Section of Health Systems Research and Policy, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'William Patrick', 'Initials': 'WP', 'LastName': 'Moran', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Elizabeth Barnhardt', 'Initials': 'EB', 'LastName': 'Kirkland', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: kirklane@musc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104267']
2792,32931919,The assertive cardiac care trial: A randomised controlled trial of a coproduced assertive cardiac care intervention to reduce absolute cardiovascular disease risk in people with severe mental illness in the primary care setting.,"BACKGROUND
Cardiovascular disease (CVD) accounts for 40% of the excess mortality identified in people with severe mental illness (SMI). Modifiable CVD risk factors are higher and can be exacerbated by the cardiometabolic impact of psychotropic medications. People with SMI frequently attend primary care presenting a valuable opportunity for early identification, prevention and management of cardiovascular health. The ACCT Healthy Hearts Study will test a coproduced, nurse-led intervention delivered with general practitioners to reduce absolute CVD risk (ACVDR) at 12 months compared with an active control group.
METHODS/DESIGN
ACCT is a two group (intervention/active control) individually randomised (1:1) controlled trial (RCT). Assessments will be completed baseline (pre-randomisation), 6 months, and 12 months. The primary outcome is 5-year ACVDR measured at 12 months. Secondary outcomes include 6-month ACVDR; and blood pressure, lipids, HbA1c, BMI, quality of life, physical activity, motivation to change health behaviour, medication adherence, alcohol use and hospitalisation at 6 and 12 months. Linear mixed-effects regression will estimate mean difference between groups for primary and secondary continuous outcomes. Economic cost-consequences analysis will be conducted using quality of life and health resource use information and routinely collected government health service use and medication data. A parallel process evaluation will investigate implementation of the intervention, uptake and outcomes.
DISCUSSION
ACCT will deliver a coproduced and person-centred, guideline level cardiovascular primary care intervention to a high need population with SMI. If successful, the intervention could lead to the reduction of the mortality gap and increase opportunities for meaningful social and economic participation. Trial registration ANZCTR Trial number: ACTRN12619001112156.",2020,"If successful, the intervention could lead to the reduction of the mortality gap and increase opportunities for meaningful social and economic participation.","['people with severe mental illness (SMI', 'people with severe mental illness in the primary care setting']",['coproduced assertive cardiac care intervention'],"['absolute CVD risk (ACVDR', '5-year ACVDR', '6-month ACVDR; and blood pressure, lipids, HbA1c, BMI, quality of life, physical activity, motivation to change health behaviour, medication adherence, alcohol use and hospitalisation at 6 and 12\u202fmonths']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.192142,"If successful, the intervention could lead to the reduction of the mortality gap and increase opportunities for meaningful social and economic participation.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Chondros', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'Deakin University, Geelong, Deakin Health Economics Unit, Faculty of Health, Australia.'}, {'ForeName': 'Yong Yi', 'Initials': 'YY', 'LastName': 'Lee', 'Affiliation': 'Deakin University, Geelong, Deakin Health Economics Unit, Faculty of Health, Australia; School of Public Health, The University of Queensland, Australia; Policy and Epidemiology Group, Queensland Centre for Mental Health Research, Australia.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Gunn', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': 'The Department of Psychiatry, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia; NorthWestern Mental Health, Melbourne, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Furler', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, Australia; Camden and Islington NHS Foundation Trust, NW1OPE, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Castle', 'Affiliation': 'The Department of Psychiatry, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Davidson', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Jayaram', 'Affiliation': 'The Department of Psychiatry, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia; NorthWestern Mental Health, Melbourne, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Kenny', 'Affiliation': 'College of Science, Health and Engineering, La Trobe Rural Health School, Violet Vines Marshman Centre for Rural Health Research, La Trobe University, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Australia.'}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Morgan', 'Affiliation': 'Neuropsychiatric Epidemiology Research Unit, School of Population and Global Health, University of Western Australia, Australia; Centre for Clinical Research in Neuropsychiatry, Division of Psychiatry, University of Western Australia, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrap', 'Affiliation': 'Department of Physiology, University of Melbourne, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'McKenzie', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Potiriadis', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Konstancja', 'Initials': 'K', 'LastName': 'Densley', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Palmer', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia. Electronic address: v.palmer@unimelb.edu.au.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106143']
2793,32933927,Effect of a pulmonary rehabilitation programme of 8 weeks compared to 12 weeks duration on exercise capacity in people with chronic obstructive pulmonary disease (PuRe Duration): protocol for a randomised controlled trial.,"INTRODUCTION
Pulmonary rehabilitation (PR) is a key component in the management of chronic obstructive pulmonary disease (COPD). There is no strong evidence on the optimal duration of PR programmes. The aim of this study is to determine whether an 8-week PR programme is equivalent to a 12-week PR programme in people with COPD.
METHODS AND ANALYSIS
This study will be a prospective, multisite, randomised controlled, equivalence trial with assessors blinded to group allocation and intention-to-treat analysis. 72 participants with COPD will be recruited and randomised to either a supervised, twice weekly for 8 weeks or a 12-week PR programme of exercise training and education.
PRIMARY OUTCOME
endurance shuttle walk test.
SECONDARY OUTCOMES
will include St George's Respiratory Questionnaire, 6-min walk distance, COPD assessment test, Hospital Anxiety and Depression Scale, physical activity monitoring and hospital admissions at 6 months and 12 months. Repeated measures analysis of variance will be used to analyse differences between the groups for all outcomes.
ETHICS AND DISSEMINATION
Ethics approval was gained from all participating sites. Results of the trial will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER
ACTRN12616001586404.",2020,"SECONDARY OUTCOMES
will include St George's Respiratory Questionnaire, 6-min walk distance, COPD assessment test, Hospital Anxiety and Depression Scale, physical activity monitoring and hospital admissions at 6 months and 12 months.","['chronic obstructive pulmonary disease (COPD', '72 participants with COPD', 'people with chronic obstructive pulmonary disease (PuRe Duration', 'people with COPD']","['pulmonary rehabilitation programme', 'Pulmonary rehabilitation (PR', 'PR programme of exercise training and education']","[""St George's Respiratory Questionnaire, 6-min walk distance, COPD assessment test, Hospital Anxiety and Depression Scale, physical activity monitoring and hospital admissions"", 'endurance shuttle walk test']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1960627', 'cui_str': 'Endurance shuttle walk test'}]",72.0,0.164128,"SECONDARY OUTCOMES
will include St George's Respiratory Questionnaire, 6-min walk distance, COPD assessment test, Hospital Anxiety and Depression Scale, physical activity monitoring and hospital admissions at 6 months and 12 months.","[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Bishop', 'Affiliation': 'Physiotherapy, Balmain Hospital, Balmain, New South Wales, Australia joshua.bishop@health.nsw.gov.au.'}, {'ForeName': 'Lissa', 'Initials': 'L', 'LastName': 'Spencer', 'Affiliation': 'Physiotherapy, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Alison', 'Affiliation': 'Physiotherapy, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000687']
2794,31397719,Emotional and behavioral resilience among children with perinatally acquired HIV in Thailand and Cambodia.,"OBJECTIVES
Psychosocial challenges associated with perinatally acquired HIV (PHIV) infection are well known, yet many children infected with HIV since birth demonstrate positive outcomes, referred to as resilience. The purpose of this study was to evaluate emotional-behavioral development and identify salient predictors of resilience among long-term survivors of PHIV.
DESIGN
Prospective investigation of children with PHIV compared with demographically similar perinatally HIV-exposed but uninfected (PHEU) and HIV-unexposed, uninfected (HUU) children, all from Thailand and Cambodia.
METHODS
The Child Behavior Checklist (CBCL; parent version) was administered at baseline and annual follow-up visits (median follow-up of 3 years) to children age 6-14. Resilience was defined as consistent CBCL scores on the Internalizing, Externalizing or Total Problem T scales within normative ranges (T-scores <60) at every time point. Generalized estimating equations examined CBCL scores over time and logistic models examined demographic, socioeconomic, and cultural predictors of resilience.
RESULTS
Participants included 448 children (236 PHIV, 98 PHEU, 114 HUU), with median (interquartile range) age at first evaluation of 7 (6-9) years. Children with PHIV exhibited similar rates of resilience as PHEU and HUU on the Externalizing and Total Problems scales. Resilience on the Internalizing scale was more likely in PHEU (71%) compared with PHIV (59%) or HUU (56%), P = 0.049. Factors associated with resilience in adjusted models included: HIV-exposed but uninfected status, higher household income, Cambodian nationality, female sex, and caregiver type.
CONCLUSION
Despite biopsychosocial risks, resilience is observed among PHIV and PHEU children. Further study is needed to understand mechanisms underlying associated factors and intervention priorities.",2019,Children with PHIV exhibited similar rates of resilience as PHEU and HUU on the Externalizing and Total Problems scales.,"['children with perinatally acquired HIV in Thailand and Cambodia', 'children with PHIV compared with demographically similar perinatally HIV-exposed but uninfected (PHEU) and HIV-unexposed, uninfected (HUU) children, all from Thailand and Cambodia', 'Participants included 448 children (236 PHIV, 98 PHEU, 114 HUU), with median (interquartile range) age at first evaluation of 7 (6-9) years']",[],"['CBCL scores on the Internalizing, Externalizing or Total Problem T scales', 'emotional-behavioral development', 'Emotional and behavioral resilience', 'Child Behavior Checklist (CBCL; parent version', 'Externalizing and Total Problems scales', 'Internalizing scale']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0006797', 'cui_str': 'Cambodia'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0442751', 'cui_str': 'Distance vision 6/9'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",448.0,0.0511227,Children with PHIV exhibited similar rates of resilience as PHEU and HUU on the Externalizing and Total Problems scales.,"[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Malee', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kerr', 'Affiliation': 'HIV-NAT, The Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'Missouri Institute of Mental Health, University of Missouri-St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'HIV-NAT, The Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Kulvadee', 'Initials': 'K', 'LastName': 'Thongpibul', 'Affiliation': 'Department of Psychology, Faculty of Humanities, Chiang Mai University, Chiang Mai.'}, {'ForeName': 'Pope', 'Initials': 'P', 'LastName': 'Kosalaraksa', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen.'}, {'ForeName': 'Pradthana', 'Initials': 'P', 'LastName': 'Ounchanum', 'Affiliation': 'Department of Pediatrics, Chiangrai Prachanukroh Hospital, Chiang Rai.'}, {'ForeName': 'Suparat', 'Initials': 'S', 'LastName': 'Kanjanavanit', 'Affiliation': 'Nakornping Hospital.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Aurpibul', 'Affiliation': 'Research Institute for Health Sciences, Chiang Mai.'}, {'ForeName': 'Chaiwat', 'Initials': 'C', 'LastName': 'Ngampiyaskul', 'Affiliation': 'Prapokklao Hospital, Chanthaburi.'}, {'ForeName': 'Wicharn', 'Initials': 'W', 'LastName': 'Luesomboon', 'Affiliation': 'Queen Savang Vadhana Memorial Hospital, Chonburi.'}, {'ForeName': 'Jurai', 'Initials': 'J', 'LastName': 'Wongsawat', 'Affiliation': 'Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand.'}, {'ForeName': 'Saphonn', 'Initials': 'S', 'LastName': 'Vonthanak', 'Affiliation': 'University of Health Science.'}, {'ForeName': 'Penh S', 'Initials': 'PS', 'LastName': 'Ly', 'Affiliation': 'National Center for HIV/AIDS Dermatology and STDs, Phnom Penh, Cambodia.'}, {'ForeName': 'Kea', 'Initials': 'K', 'LastName': 'Chettra', 'Affiliation': 'National Center for HIV/AIDS Dermatology and STDs, Phnom Penh, Cambodia.'}, {'ForeName': 'Tulathip', 'Initials': 'T', 'LastName': 'Suwanlerk', 'Affiliation': 'HIV-NAT, The Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Jiratchaya', 'Initials': 'J', 'LastName': 'Sophonphan', 'Affiliation': 'HIV-NAT, The Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Valcour', 'Affiliation': 'Department of Neurology, Memory and Aging Center, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Jintanat', 'Initials': 'J', 'LastName': 'Ananworanich', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Claude A', 'Initials': 'CA', 'LastName': 'Mellins', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute, Columbia University, New York, New York, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002182']
2795,32950737,"A pragmatic stepped-wedge cluster randomized trial to evaluate the effectiveness and cost-effectiveness of active case finding for household contacts within a routine tuberculosis program, San Juan de Lurigancho, Lima, Peru.","BACKGROUND
Active case finding (ACF) in household contacts of tuberculosis (TB) patients is now recommended for National TB Programs (NTP) in low- and middle-income countries. However, evidence supporting these recommendations remains limited. This study evaluates the effectiveness and cost-effectiveness of ACF for household contacts of TB cases in a large TB endemic district of Lima, Peru.
METHODS
A pragmatic stepped-wedge cluster randomized controlled trial was conducted in 34 health centers of San Juan de Lurigancho district. Centers were stratified by TB rate and randomly allocated to initiate ACF in groups of eight or nine centers at four-month intervals. In the intervention arm, NTP providers visited households of index patients to screen contacts for active TB. The control arm was routine passive case finding (PCF) of symptomatic TB cases. The primary outcomes were the crude and adjusted active TB case rates among household contacts. Program costs were directly measured, and the cost-effectiveness of the ACF intervention was determined.
FINDINGS
3222 index TB cases and 12,566 household contacts were included in the study. ACF identified more household contact TB cases than PCF, 199.29/10,000 contacts/year vs. 132.13 (incidence rate ratio of 1.51 (95% CI 1.21-1.88)). ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6360.
CONCLUSION
ACF of TB case household contacts detected significantly more secondary TB cases than PCF alone, but was not cost-effective in this setting. In threshold analyses, ACF becomes cost-effective if associated with case detection rates 2.5 times higher than existing PCF programs.",2020,"ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6,360.
","['household contacts of tuberculosis (TB) patients', '34 health centers of San Juan de Lurigancho district', 'household contacts of TB cases in a large TB endemic district of Lima, Peru', '3,222 index TB cases and 12,566 household contacts were included in the study']","['PCF', 'ACF']","['effectiveness and cost-effectiveness', 'crude and adjusted active TB case rates among household contacts', 'Program costs']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.240111,"ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6,360.
","[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Shah', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Rojas Peña', 'Affiliation': 'Red de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Peru.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Mori', 'Affiliation': 'Red de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Peru.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zamudio', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Kaufman', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Otero', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Gotuzzo', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Seas', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru; Departamento de Enfermedades Infecciosas, Tropicales y Dermatológicas, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Brewer', 'Affiliation': 'Departments of Medicine and Epidemiology, David Geffen School of Medicine, Jonathan & Karin Fielding School of Public Health, University of California, Los Angeles, CA, United States. Electronic address: tbrewer@mednet.ucla.edu.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.09.034']
2796,32950763,Stress-induced modulation of multiple memory systems during retrieval requires noradrenergic arousal.,"Stress has been shown to favor dorsal striatum-dependent 'habit' memory over hippocampus-dependent 'cognitive' memory during learning. Here, we investigated whether stress may modulate the engagement of these 'cognitive' and 'habit' systems also during memory retrieval and if so, whether such a stress-induced shift in the control of memory retrieval depends on noradrenergic activation. To this end, participants acquired a probabilistic classification learning (PCL) task that can be solved by both the 'cognitive' and the 'habit' system, reflected in the distinct behavioral strategies. Twenty-four hours later, participants received either the beta-adrenergic receptor antagonist propranolol or a placebo before they underwent a psychosocial stressor or a non-stressful control manipulation, followed by a retrieval version of the PCL task. Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory. Stressed participants that had received a placebo fell back to a 'cognitive' strategy during retrieval, which was linked to an impairment in retrieval performance. Propranolol blocked this stress-induced shift towards the less efficient strategy. Moreover, our results showed that salivary cortisol was related to the retrieval strategy only when paralleled by increased autonomic arousal. Together, these results indicate that stress effects on the modulation of multiple memory system during retrieval necessitate noradrenergic arousal, with relevant implications for retrieval performance under stress.",2020,"Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory.",[],"['Propranolol', 'placebo', 'beta-adrenergic receptor antagonist propranolol or a placebo']","['autonomic arousal', 'salivary cortisol']",[],"[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",,0.0560178,"Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory.","[{'ForeName': 'Gundula', 'Initials': 'G', 'LastName': 'Zerbes', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany.'}, {'ForeName': 'Franziska Magdalena', 'Initials': 'FM', 'LastName': 'Kausche', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany.'}, {'ForeName': 'Jana Christina', 'Initials': 'JC', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Wiedemann', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schwabe', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany. Electronic address: lars.schwabe@uni-hamburg.de.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104867']
2797,32917187,Improving the informatics competency of critical care nurses: results of an interventional study in the southeast of Iran.,"BACKGROUND
Nursing informatics (NI) along with growth and development of health information technology (HIT) is becoming a fundamental part of all domains of nursing practice especially in critical care settings. Nurses are expected to equip with NI competency for providing patient-centered evidence-based care. Therefore, it is important and necessary to improve nurses' NI competency through educational programs for effective using of HIT. This study aimed to evaluate the impact of a training program on NI competency of critical care nurses.
METHODS
This interventional study was conducted in 2019. Stratified sampling technique was used to select 60 nurses working in critical care units of three hospitals affiliated with a large University of Medical Sciences in the southeast of Iran. These nurses were assigned randomly and equally to the control and intervention groups. NI competency was trained to the intervention group in a three-day workshop. Data were collected using demographic questionnaire and the adapted Nursing Informatics Competency Assessment Tool (NICAT) before and 1 month after the intervention. Rahman in the US (2015) developed and validated the original NICAT to assess self-reported NI competency of nurses with 30 items and three dimensions (Computer literacy, Informatics literacy Information management skills). The NICAT is scored on a five-point Likert scale and the overall score ranges from 30 to150. Two medical informatics specialists and eight nursing faculty members approved the validity of the adapted version of NICAT and its reliability was confirmed by Cronbach's alpha (95%).
RESULTS
All 60 participants completed the educational program and returned the completed questionnaire. Majority of participants in the intervention and control groups were female (83.30%), married nurses (70.90, 73.30%) aged 30-40 years (51.6, 35.5%). In the pretest stage, both intervention and control groups were competent in terms of the NI competency and its dimensions, and no significant difference was observed between them (p = 0.65). However, in the posttest, the NI competency and its dimensions in the intervention group significantly increased with a large effect size compared with the control group (p = 0.001). This difference showed that the intervention group was proficient in the posttest stage. The highest mean difference in the intervention group was associated with the informatics literacy dimension and the lowest mean difference was associated with the informatics management skills dimension.
CONCLUSIONS
The improved scores of NI competency and its dimensions after using the training program implied the effectiveness of this method in enhancing the NI competency of nurses working in the critical care units. The application of the training program in diverse domains of nursing practice shows its high efficiency. The project is fundamental for improving nurses' NI competency through continuous educational programs in Iran, other cultures and contexts.",2020,"However, in the posttest, the NI competency and its dimensions in the intervention group significantly increased with a large effect size compared with the control group (p = 0.001).","['All 60 participants completed the educational program and returned the completed questionnaire', 'Majority of participants in the intervention and control groups were female (83.30%), married nurses (70.90, 73.30%) aged 30-40\u2009years (51.6, 35.5', '60 nurses working in critical care units of three hospitals affiliated with a large University of Medical Sciences in the southeast of Iran', 'critical care nurses', 'southeast of Iran']",['training program'],['informatics literacy dimension'],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0599807', 'cui_str': 'Informatics'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",,0.0237001,"However, in the posttest, the NI competency and its dimensions in the intervention group significantly increased with a large effect size compared with the control group (p = 0.001).","[{'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Jouparinejad', 'Affiliation': 'Student Research Committee, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Foroughameri', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, PO Box: 7716913555, Kerman, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Khajouei', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Farokhzadian', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, PO Box: 7716913555, Kerman, Iran. j.farokhzadian@kmu.ac.ir.'}]",BMC medical informatics and decision making,['10.1186/s12911-020-01244-5']
2798,32917221,"The use of Lactobacillus plantarum 299v (DSM 9843) in cancer patients receiving home enteral nutrition - study protocol for a randomized, double-blind, and placebo-controlled trial.","BACKGROUND
Nutritional treatment is one of the most important components of multidisciplinary anti-cancer therapy. Home enteral nutrition is considered as a safe procedure, however, it may be associated with the risk of side effects, such as nausea, vomiting, abdominal pain, and diarrhoea. It is uncertain whether diarrhoea is the result of the enteral formula administration or gut dysbiosis. One of the methods which may be used to alter the composition of gut microbiota is the administration of a probiotic strain. Lactobacillus plantarum 299v ingestion was found to diminish the adverse events of irritable bowel syndrome and Clostridium difficile infection - entities that share the symptoms with enteral nutrition side effects. Therefore, the primary aim of this study is to determine the effect of Lactobacillus plantarum 299v on prevention of weight loss of cancer patients receiving home enteral nutrition. The secondary aims are to evaluate the role of this probiotic strain in the improvement of nutritional status, enteral nutrition tolerance, and patients' quality of life.
METHODS
Forty patients with cancer receiving home enteral nutrition will be enrolled in this clinical trial and randomized to receive one capsule of Lactobacillus plantarum 299v (Sanprobi IBS®) twice a day or placebo for 12 weeks in a double-blind manner. Laboratory tests (the level of albumin, total protein, transferrin, and total lymphocyte count), anthropometric parameters (body mass, the content of fat mass, muscle mass, and total body water), Nutritional Risk Screening (NRS 2002), enteral nutrition tolerance as well as quality of life will be measured. Measurements will be obtained at the baseline and after 4 and 12 weeks of treatment.
DISCUSSION
The adverse events observed during administration of enteral nutrition have an negative impact on enteral formula tolerance and as a consequence patients' quality of life. The previous studies have demonstrated that probiotics may reduce the gastrointestinal symptoms related to enteral nutrition. Thus, administration of Lactobacillus plantarum 299v may be effective in improvement of nutritional status, enteral nutrition tolerance, and quality of life of cancer patients receiving home enteral nutrition.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03940768 .",2020,Lactobacillus plantarum 299v ingestion was found to diminish the adverse events of irritable bowel syndrome and Clostridium difficile infection - entities that share the symptoms with enteral nutrition side effects.,"['cancer patients receiving home enteral nutrition', 'cancer patients receiving home enteral nutrition - study protocol', 'Forty patients with cancer receiving home enteral nutrition']","['Lactobacillus plantarum 299v ingestion', 'Lactobacillus plantarum', 'enteral nutrition', 'Lactobacillus plantarum 299v', 'placebo', 'Lactobacillus plantarum 299v (DSM 9843', 'Lactobacillus plantarum 299v (Sanprobi IBS®) twice a day or placebo']","['weight loss', 'Laboratory tests (the level of albumin, total protein, transferrin, and total lymphocyte count), anthropometric parameters (body mass, the content of fat mass, muscle mass, and total body water), Nutritional Risk Screening (NRS 2002), enteral nutrition tolerance as well as quality of life', 'adverse events', 'nutritional status, enteral nutrition tolerance, and quality of life', 'nausea, vomiting, abdominal pain, and diarrhoea']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",40.0,0.0968996,Lactobacillus plantarum 299v ingestion was found to diminish the adverse events of irritable bowel syndrome and Clostridium difficile infection - entities that share the symptoms with enteral nutrition side effects.,"[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Kaźmierczak-Siedlecka', 'Affiliation': 'Department of Surgical Oncology, Medical University of Gdansk, Mariana Smoluchowskiego 17, 80-214, Gdansk, Poland. leokadia@gumed.edu.pl.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Folwarski', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Medical University of Gdansk, Dębinki 7, 80-211, Gdansk, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Skonieczna-Żydecka', 'Affiliation': 'Department of Human Nutrition and Metabolomics, Pomeranian Medical University in Szczecin, Broniewskiego 24, 71-460, Szczecin, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Ruszkowski', 'Affiliation': 'Department of Physiopathology, Medical University of Gdansk, Dębinki 7, 80-211, Gdansk, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Makarewicz', 'Affiliation': 'Department of Surgical Oncology, Medical University of Gdansk, Mariana Smoluchowskiego 17, 80-214, Gdansk, Poland.'}]",Nutrition journal,['10.1186/s12937-020-00598-w']
2799,32920787,Understanding the mechanisms of placebo and nocebo effects.,"Although placebos have long been considered a nuisance in clinical research, over recent years they have become an active and productive field of research. Indeed, the placebo effect represents an elegant model to understand how the brain works. It is worth knowing that there is not a single but many placebo effects, with different mechanisms across different systems, medical conditions and therapeutic interventions. For example, brain mechanisms of expectation, anxiety and reward are all involved, as well as a variety of learning phenomena. There is also some experimental evidence of different genetic variants in placebo responsiveness. Pain and Parkinson’s disease represent the most productive models to better understand the neurobiology of the placebo effect. In these medical conditions the neural networks involved have indeed been identified: that is, opioid, cannabinoid, cholecystokinin, cyclooxygenase, and dopamine modulatory networks in pain; and part of the basal ganglia circuitry in Parkinson’s disease. Overall, there is today compelling evidence that placebos and drugs share common biochemical pathways and activate the same receptor pathways, which suggests possible interference between social stimuli and therapeutic rituals on one hand and pharmacological agents on the other. The same holds true for the nocebo effect, the opposite phenomenon of placebo. The assessment of patients’ expectations should become the rule in clinical trials in order to allow us a better interpretation of therapeutic outcomes when comparing placebo and active treatment groups. Administering drugs covertly is another way to identify the placebo psychobiological component without the administration of any placebo, and this provides important information on the role of patient’s expectations in the therapeutic outcome. A further in-depth analysis of placebo and nocebo phenomena will certainly provide important information in the near future for a better understanding of human biology, medicine and society.",2020,"The same holds true for the nocebo effect, the opposite phenomenon of placebo.",[],"['placebo', 'placebos']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.1892,"The same holds true for the nocebo effect, the opposite phenomenon of placebo.","[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Frisaldi', 'Affiliation': 'University of Turin Medical School, Neuroscience Department, Turin, Italy.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Shaibani', 'Affiliation': 'Nerve and Muscle Center of Texas, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Benedetti', 'Affiliation': 'University of Turin Medical School, Neuroscience Department, Turin, Italy / Medicine and Physiology of Hypoxia, Plateau Rosà, Switzerland.'}]",Swiss medical weekly,['10.4414/smw.2020.20340']
2800,32920792,Value of the TTM risk score for early prognostication of comatose patients after out-of-hospital cardiac arrest in a Swiss university hospital.,"Comatose patients admitted to the intensive care unit (ICU) after out-of-hospital cardiac arrest frequently die after withdrawal of life support. Guidelines recommend scheduling prognostication no sooner than 96 hours after cardiac arrest, and strict withdrawal criteria leave many patients waiting for improvement for days without ever reaching a favourable outcome. In clinical practice, physicians are frequently confronted with vague living wills expressed by next of kin or an imprecise advance care directive soon after cardiac arrest. Often a decision to admit a patient to an ICU or limiting ICU treatment in terms of time or intensity is made early, based on the patient’s preferences. The Target Temperature Management (TTM) risk score is an imperfect measure that predicts outcome early, at the time of ICU admission. It was developed on a data set of 939 patients included in the TTM Trial, a study in which unconscious patients after cardiac arrest were randomised into two temperature management arms. Patient selection in that trial might impede generalisability. We aimed to validate the TTM risk score with 100 consecutive patients treated in our ICU. Although we had different survival rates, reflecting a different patient population, we were able to confirm the score’s albeit imperfect ability to predict outcome early after cardiac arrest. The suggested cut-off values of 10 and 16 can be used as a basis for discussion with the family; in particular, a risk score value below 10 predicts a favourable outcome and might guide early discussion. As in the original study, the outcome of an individual patient cannot be predicted. (ClinicalTrials.gov Identifier: NCT02722460).",2020,"The Target Temperature Management (TTM) risk score is an imperfect measure that predicts outcome early, at the time of ICU admission.","['939 patients included in the TTM Trial, a study in which unconscious patients after cardiac arrest', 'Comatose patients admitted to the intensive care unit (ICU) after out-of-hospital cardiac arrest frequently die after withdrawal of life support', '100 consecutive patients treated in our ICU', 'comatose patients after out-of-hospital cardiac arrest in a Swiss university hospital']",[],"['survival rates', 'Target Temperature Management (TTM) risk score', 'TTM risk score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041654', 'cui_str': 'Unconscious (Psychology)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1963783', 'cui_str': 'Withdrawal of life support'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]",[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035649', 'cui_str': 'Risk management'}]",,0.0311344,"The Target Temperature Management (TTM) risk score is an imperfect measure that predicts outcome early, at the time of ICU admission.","[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Kägi', 'Affiliation': 'Department of Intensive Care Medicine, Bern University Hospital, Inselspital, University of Bern, Switzerland.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Weck', 'Affiliation': 'Department of Intensive Care Medicine, Bern University Hospital, Inselspital, University of Bern, Switzerland / Department of Intensive Care Medicine, Hospital Region Biel/Bienne, Switzerland.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Iten', 'Affiliation': 'Department of Intensive Care Medicine, Bern University Hospital, Inselspital, University of Bern, Switzerland.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Levis', 'Affiliation': 'Department of Intensive Care Medicine, Bern University Hospital, Inselspital, University of Bern, Switzerland / Department of Anaesthesiology and Pain Medicine, Bern University Hospital, Inselspital, University of Bern, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Haenggi', 'Affiliation': 'Department of Intensive Care Medicine, Bern University Hospital, Inselspital, University of Bern, Switzerland.'}]",Swiss medical weekly,['10.4414/smw.2020.20344']
2801,32922802,Correction to: Low-chloride- versus high-chloride-containing hypertonic solution for the treatment of subarachnoid hemorrhage-related complications: The ACETatE (A low ChloriE hyperTonic solution for brain Edema) randomized trial.,[This corrects the article DOI: 10.1186/s40560-020-00449-0.].,2020,[This corrects the article DOI: 10.1186/s40560-020-00449-0.].,['subarachnoid hemorrhage-related complications'],['Low-chloride- versus high-chloride-containing hypertonic solution'],[],"[{'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0860861', 'cui_str': 'Cl- decreased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0020554', 'cui_str': 'Hypertonic solutions'}]",[],,0.0584523,[This corrects the article DOI: 10.1186/s40560-020-00449-0.].,"[{'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Sadan', 'Affiliation': 'Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Singbartl', 'Affiliation': 'Department of Critical Care Medicine, Mayo Clinic, 5777 E Mayo Blvd, Phoenix, AZ 85054 USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Kraft', 'Affiliation': 'Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Joao McONeil', 'Initials': 'JM', 'LastName': 'Plancher', 'Affiliation': 'Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Alexander C M', 'Initials': 'ACM', 'LastName': 'Greven', 'Affiliation': 'School of Medicine, Emory University, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Kandiah', 'Affiliation': 'Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Cederic', 'Initials': 'C', 'LastName': 'Pimentel', 'Affiliation': 'Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Hall', 'Affiliation': 'Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Papangelou', 'Affiliation': 'Department of Anesthesiology, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Asbury', 'Affiliation': 'Department of Pharmacy, Emory University Hospital, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Hanfelt', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Emory University, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Samuels', 'Affiliation': 'Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}]",Journal of intensive care,['10.1186/s40560-020-00485-w']
2802,32920135,"Therapeutic effects of andiroba (Carapa guianensis Aubl) oil, compared to low power laser, on oral mucositis in children underwent chemotherapy: A clinical study.","ETHNO-PHARMACOLOGICAL RELEVANCE
The Carapa guianensis Aubl, popularly known as andiroba, is a large tree of the Meliaceae family, commonly found in the Amazon region. The oil extracted from its seeds is recognized in traditional medicine and has high anti-inflammatory and analgesic potential, which are the basic prerequisites for a therapeutic agent that can be used in the treatment of oral mucositis (OM). Moreover, the aforementioned oil has antimicrobial, antiallergic, and parasiticidal actions and is effective in the management of cutaneous and muscular dysfunctions.
AIM OF THE STUDY
To evaluate the therapeutic effects of andiroba gel (Carapa guianensis Aubl) on the symptomatology and evolution of OM in children with leukemia who underwent chemotherapy and to compare it to the effects of low power laser.
MATERIALS AND METHODS
This randomized, double-blind clinical trial involved 60 patients of both genders with leukemia, with age ranging from six to twelve years. The patients were divided into two study groups: the andiroba group (n = 30) and the laser group (n = 30). The level of pain experienced by the patients was assessed using the Wong-Baker visual analog scale and the degree of severity of OM was assessed using a table, recommended by the World Health Organization, that depicts the degrees of severity of OM. The data obtained were analyzed using the Mann-Whitney test, with statistical significance indicated by a P value less than or equal to 0.05.
RESULTS
A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
CONCLUSIONS
The use of andiroba oil effectively reduced the severity of OM and relieved pain, which resulted in a decrease in the severity of signs and symptoms in the patients in the andiroba group, compared to the laser group.",2021,"RESULTS
A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
","['children underwent', 'children with leukemia who underwent', '60 patients of both genders with leukemia, with age ranging from six to twelve years']","['andiroba gel (Carapa guianensis Aubl', 'chemotherapy', 'andiroba (Carapa guianensis Aubl) oil']","['Baker visual analog scale and the degree of severity of OM', 'degree of OM', 'severity of OM and relieved pain', 'level of pain', 'pain scores', 'severity of signs and symptoms', 'oral mucositis', 'symptomatology and evolution of OM']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1258042', 'cui_str': 'Carapa'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0441982', 'cui_str': 'Degrees of severity'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}]",60.0,0.0241249,"RESULTS
A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
","[{'ForeName': 'Artur Dos Santos', 'Initials': 'ADS', 'LastName': 'Soares', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: artur_soares_@hotmail.com.'}, {'ForeName': 'Ana Márcia Viana', 'Initials': 'AMV', 'LastName': 'Wanzeler', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: marciawanzeler@hotmail.com.'}, {'ForeName': 'Gabriel Henrique Soares', 'Initials': 'GHS', 'LastName': 'Cavalcante', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: gabrielhscavalcante@gmail.com.'}, {'ForeName': 'Elsa Maria da Silva', 'Initials': 'EMDS', 'LastName': 'Barros', 'Affiliation': 'Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: elsabarros12345@gmail.com.'}, {'ForeName': 'Rita de Cássia Matos', 'Initials': 'RCM', 'LastName': 'Carneiro', 'Affiliation': 'Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: ritacarneiro69@yahoo.com.br.'}, {'ForeName': 'Fabrício Mesquita', 'Initials': 'FM', 'LastName': 'Tuji', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil; Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: fmtuji@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113365']
2803,32928792,Efficacy and safety of insulin glargine 300 U/mL (Gla-300) during hospitalization and therapy intensification at discharge in patients with insufficiently controlled type 2 diabetes: results of the phase IV COBALTA trial.,"INTRODUCTION
This study assessed the efficacy and safety of insulin glargine 300 U/mL (Gla-300) during hospitalization and therapy intensification at discharge in insufficiently controlled people with type 2 diabetes.
RESEARCH DESIGN AND METHODS
COBALTA (for its acronym in Spanish, COntrol Basal durante la hospitalizacion y al ALTA) was a multicenter, open-label, single-arm, phase IV trial including 112 evaluable inpatients with type 2 diabetes insufficiently controlled (glycosylated hemoglobin (HbA1c) 8%-10%) with basal insulin and/or non-insulin antidiabetic drugs. Patients were treated with a basal-bolus-correction insulin regimen with Gla-300 during the hospitalization and with Gla-300 and/or non-insulin antidiabetics for 6 months after discharge. The primary endpoint was the HbA1c change from baseline to month 6 postdischarge.
RESULTS
HbA1c levels decreased from 8.8%±0.6% at baseline to 7.2%±1.1% at month 6 postdischarge (p<0.001, mean change 1.6%±1.1%). All 7-point blood glucose levels decreased from baseline to 24 hours predischarge (p≤0.001, mean changes from 25.1±66.6 to 63.0±85.4 mg/dL). Fasting plasma glucose also decreased from baseline to 24 hours predischarge (p<0.001), month 3 (p<0.001) and month 6 (p<0.001) postdischarge (mean changes 51.5±90.9, 68.2±96.0 and 77.6±86.4 mg/dL, respectively). Satisfaction was high and hyperglycemia/hypoglycemia perception was low according to the Diabetes Treatment Satisfaction Questionnaire at month 6 postdischarge. The incidence of confirmed (glucose<70 mg/dL)/severe hypoglycemia was 25.0% during hospitalization and 59.1% 6 months after discharge. No safety concerns were reported.
CONCLUSIONS
Inpatient and intensification therapy at discharge with Gla-300 improved significantly glycemic control of patients with type 2 diabetes insufficiently controlled with other basal insulin and/or non-insulin antidiabetic medication, with high treatment satisfaction. Gla-300 could therefore be a treatment choice for hospital and postdischarge diabetes management.",2020,"Fasting plasma glucose also decreased from baseline to 24 hours predischarge (p<0.001), month 3 (p<0.001) and month 6 (p<0.001) postdischarge (mean changes 51.5±90.9, 68.2±96.0 and 77.6±86.4 mg/dL, respectively).","['COBALTA (for its acronym in Spanish', '112 evaluable inpatients with type', 'patients with type 2 diabetes', 'patients with insufficiently controlled type 2 diabetes']","['basal insulin and/or non-insulin antidiabetic drugs', 'basal-bolus-correction insulin regimen with Gla-300 during the hospitalization and with Gla-300 and/or non-insulin antidiabetics', 'U/mL (Gla-300', 'insulin glargine 300 U/mL (Gla-300', 'insulin glargine 300', 'Gla-300']","['glycemic control', 'All 7-point blood glucose levels', 'efficacy and safety', 'Satisfaction was high and hyperglycemia/hypoglycemia perception', 'Efficacy and safety', 'HbA1c levels', 'HbA1c change from baseline to month 6 postdischarge', 'Fasting plasma glucose', 'incidence of confirmed (glucose<70\u2009mg/dL)/severe hypoglycemia']","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]",112.0,0.0286274,"Fasting plasma glucose also decreased from baseline to 24 hours predischarge (p<0.001), month 3 (p<0.001) and month 6 (p<0.001) postdischarge (mean changes 51.5±90.9, 68.2±96.0 and 77.6±86.4 mg/dL, respectively).","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital de la Santa Creu i Sant Pau, CIBER de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Universitat Autònoma de Barcelona, Barcelona, Spain aperez@santpau.cat.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Carrasco-Sánchez', 'Affiliation': 'Department of Internal Medicine, Hospital Universitario Juan Ramón Jiménez, Huelva, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'González', 'Affiliation': 'Department of Internal Medicine, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Seguí-Ripoll', 'Affiliation': ""Department of Internal Medicine, Hospital Universitario San Joan d'Alacant, Sant Joan d'Alacant, Spain.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Trescolí', 'Affiliation': 'Department of Internal Medicine, Hospital Universitario de La Ribera, Alzira, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ena', 'Affiliation': 'Department of Internal Medicine, Hospital Marina Baixa, Villajoyosa, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Borrell', 'Affiliation': 'Medical Department, Sanofi, Barcelona, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gomez Huelgas', 'Affiliation': 'Department of Internal Medicine, Hospital Regional Universitario de Málaga, Málaga, Instituto de Investigación Biomédica de Málaga, Universidad de Málaga; CIBER Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001518']
2804,32928798,"Does adherence to evidence-based practices during childbirth prevent perinatal mortality? A post-hoc analysis of 3,274 births in Uttar Pradesh, India.","BACKGROUND
Evidence-based practices that reduce childbirth-related morbidity and mortality are core processes to quality of care. In the BetterBirth trial, a matched-pair, cluster-randomised controlled trial of a coaching-based implementation of the WHO Safe Childbirth Checklist (SCC) in Uttar Pradesh, India, we observed a significant increase in adherence to practices, but no reduction in perinatal mortality.
METHODS
Within the BetterBirth trial, we observed birth attendants in a subset of study sites providing care to labouring women to assess the adherence to individual and groups of practices. We observed care from admission to the facility until 1 hour post partum. We followed observed women/newborns for 7-day perinatal health outcomes. Using this observational data, we conducted a post-hoc, exploratory analysis to understand the relationship of birth attendants' practice adherence to perinatal mortality.
FINDINGS
Across 30 primary health facilities, we observed 3274 deliveries and obtained 7-day health outcomes. Adherence to individual practices, containing supply preparation and direct provider care, varied widely (0·51 to 99·78%). We recorded 166 perinatal deaths (50·71 per 1000 births), including 56 (17·1 per 1000) stillbirths. Each additional practice performed was significantly associated with reduced odds of perinatal (OR: 0·82, 95% CI: 0·72, 0·93) and early neonatal mortality (OR: 0·78, 95% CI: 0·71, 0·85). Each additional practice as part of direct provider care was associated strongly with reduced odds of perinatal (OR: 0·73, 95% CI: 0·62, 0·86) and early neonatal mortality (OR: 0·67, 95% CI: 0·56, 0·80). No individual practice or single supply preparation was associated with perinatal mortality.
INTERPRETATION
Adherence to practices on the WHO SCC is associated with reduced mortality, indicating that adherence is a valid indicator of higher quality of care. However, the causal relationships between practices and outcomes are complex.
FUNDING
Bill & Melinda Gates Foundation.
TRIAL REGISTRATION DETAILS
ClinicalTrials.gov: NCT02148952; Universal Trial Number: U1111-1131-5647.",2020,"Adherence to individual practices, containing supply preparation and direct provider care, varied widely (0·51 to 99·78%).","['Within the BetterBirth trial', 'Across 30 primary health facilities, we observed 3274 deliveries and obtained 7-day health outcomes', '166 perinatal deaths (50·71 per 1000 births), including 56 (17·1 per 1000) stillbirths', '3,274 births in Uttar Pradesh, India']",['coaching-based implementation of the WHO Safe Childbirth Checklist (SCC'],"['early neonatal mortality', 'perinatal mortality', 'early neonatal mortality ']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]","[{'cui': 'C1271991', 'cui_str': 'Early neonatal death'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}]",,0.256585,"Adherence to individual practices, containing supply preparation and direct provider care, varied widely (0·51 to 99·78%).","[{'ForeName': 'Katherine Ea', 'Initials': 'KE', 'LastName': 'Semrau', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA ksemrau@ariadnelabs.org.""}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Miller', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Lipsitz', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fisher-Bowman', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Karlage', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Neville', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Krasne', 'Affiliation': 'Department of Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Gass', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Jurczak', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Pratap Singh', 'Affiliation': 'Community Empowerment Lab, Lucknow, India.'}, {'ForeName': 'Shambhavi', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Community Empowerment Lab, Lucknow, India.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Marx Delaney', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Hirschhorn', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Bhalachandra', 'Initials': 'B', 'LastName': 'Kodkany', 'Affiliation': 'Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.'}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Community Empowerment Lab, Lucknow, India.'}, {'ForeName': 'Atul A', 'Initials': 'AA', 'LastName': 'Gawande', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}]",BMJ global health,['10.1136/bmjgh-2019-002268']
2805,32925045,White Matter Changes on Diffusion Tensor Imaging in the FINGER Randomized Controlled Trial.,"BACKGROUND
Early pathological changes in white matter microstructure can be studied using the diffusion tensor imaging (DTI). It is not only important to study these subtle pathological changes leading to cognitive decline, but also to ascertain how an intervention would impact the white matter microstructure and cognition in persons at-risk of dementia.
OBJECTIVES
To study the impact of a multidomain lifestyle intervention on white matter and cognitive changes during the 2-year Finnish Geriatric Intervention Study to prevent Cognitive Impairment and Disability (FINGER), a randomized controlled trial in at-risk older individuals (age 60-77 years) from the general population.
METHODS
This exploratory study consisted of a subsample of 60 FINGER participants. Participants were randomized to either a multidomain intervention (diet, exercise, cognitive training, and vascular risk management, n = 34) or control group (general health advice, n = 26). All underwent baseline and 2-year brain DTI. Changes in fractional anisotropy (FA), diffusivity along domain (F1) and non-domain (F2) diffusion orientations, mean diffusivity (MD), axial diffusivity (AxD), radial diffusivity (RD), and their correlations with cognitive changes during the 2-year multidomain intervention were analyzed.
RESULTS
FA decreased, and cognition improved more in the intervention group compared to the control group (p < 0.05), with no significant intergroup differences for changes in F1, F2, MD, AxD, or RD. The cognitive changes were significantly positively related to FA change, and negatively related to RD change in the control group, but not in the intervention group.
CONCLUSION
The 2-year multidomain FINGER intervention may modulate white matter microstructural alterations.",2020,"RESULTS
FA decreased, and cognition improved more in the intervention group compared to the control group (p < 0.05), with no significant intergroup differences for changes in F1, F2, MD, AxD, or RD.","['at-risk older individuals (age 60-77 years) from the general population', 'subsample of 60 FINGER participants', 'white matter and cognitive changes during the 2-year Finnish Geriatric Intervention Study to prevent Cognitive Impairment and Disability (FINGER']","['multidomain intervention (diet, exercise, cognitive training, and vascular risk management, n\u200a=\u200a34) or control group (general health advice, n\u200a=\u200a26', 'multidomain FINGER intervention', 'multidomain lifestyle intervention']","['FA decreased, and cognition', 'F1, F2, MD, AxD, or RD', 'cognitive changes', 'fractional anisotropy (FA), diffusivity along domain (F1) and non-domain (F2) diffusion orientations, mean diffusivity (MD), axial diffusivity (AxD), radial diffusivity (RD), and their correlations with cognitive changes', 'RD change']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035649', 'cui_str': 'Risk management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0332287', 'cui_str': 'With'}]",60.0,0.0249422,"RESULTS
FA decreased, and cognition improved more in the intervention group compared to the control group (p < 0.05), with no significant intergroup differences for changes in F1, F2, MD, AxD, or RD.","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Stephen', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Tiia', 'Initials': 'T', 'LastName': 'Ngandu', 'Affiliation': 'Division of Clinical Geriatrics, Center for Alzheimer Research, NVS, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Esko', 'Initials': 'E', 'LastName': 'Levälahti', 'Affiliation': 'Public Health Promotion Unit, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Juha O', 'Initials': 'JO', 'LastName': 'Rinne', 'Affiliation': 'Division of Clinical Neurosciences, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kemppainen', 'Affiliation': 'Division of Clinical Neurosciences, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Parkkola', 'Affiliation': 'Division of Clinical Neurosciences, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Antikainen', 'Affiliation': 'Center for Life Course Health Research/Geriatrics, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Strandberg', 'Affiliation': 'Center for Life Course Health Research/Geriatrics, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Kivipelto', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Hilkka', 'Initials': 'H', 'LastName': 'Soininen', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Yawu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200423']
2806,32926841,"Quality of life in patients with metastatic prostate cancer following treatment with cabazitaxel versus abiraterone or enzalutamide (CARD): an analysis of a randomised, multicentre, open-label, phase 4 study.","BACKGROUND
In the CARD study, cabazitaxel significantly improved radiographic progression-free survival and overall survival versus abiraterone or enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel and the alternative androgen signalling-targeted inhibitor. Here, we report the quality-of-life outcomes from the CARD study.
METHODS
CARD was a randomised, multicentre, open-label, phase 4 study involving 62 clinical sites across 13 European countries. Patients (aged ≥18 years, Eastern Cooperative Oncology Group (ECOG) performance status ≤2) with confirmed metastatic castration-resistant prostate cancer were randomly assigned (1:1) by means of an interactive voice-web response system to receive cabazitaxel (25 mg/m 2 intravenously every 3 weeks, 10 mg daily prednisone, and granulocyte colony-stimulating factor) versus abiraterone (1000 mg orally once daily plus 5 mg prednisone twice daily) or enzalutamide (160 mg orally daily). Stratification factors were ECOG performance status, time to disease progression on the previous androgen signalling-targeted inhibitor, and timing of the previous androgen signalling-targeted inhibitor. The primary endpoint was radiographic progression-free survival; here, we present more detailed analyses of pain (assessed using item 3 on the Brief Pain Inventory-Short Form [BPI-SF]) and symptomatic skeletal events, alongside preplanned patient-reported outcomes, assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and the EuroQoL-5 dimensions, 5 level scale (EQ-5D-5L). Efficacy analyses were done in the intention-to-treat population. Pain response was analysed in the intention-to-treat population with baseline and at least one post-baseline assessment of BPI-SF item 3, and patient-reported outcomes (PROs) were analysed in the intention-to-treat population with baseline and at least one post-baseline assessment of either FACT-P or EQ-5D-5L (PRO population). Analyses of skeletal-related events were also done in the intention-to-treat population. The CARD study is registered with ClinicalTrials.gov, NCT02485691, and is no longer enrolling.
FINDINGS
Between Nov 17, 2015, and Nov 28, 2018, of 303 patients screened, 255 were randomly assigned to cabazitaxel (n=129) or abiraterone or enzalutamide (n=126). Median follow-up was 9·2 months (IQR 5·6-13·1). Pain response was observed in 51 (46%) of 111 patients with cabazitaxel and 21 (19%) of 109 patients with abiraterone or enzalutamide (p<0·0001). Median time to pain progression was not estimable (NE; 95% CI NE-NE) with cabazitaxel and 8·5 months (4·9-NE) with abiraterone or enzalutamide (hazard ratio [HR] 0·55, 95% CI 0·32-0·97; log-rank p=0·035). Median time to symptomatic skeletal events was NE (95% CI 20·0-NE) with cabazitaxel and 16·7 months (10·8-NE) with abiraterone or enzalutamide (HR 0·59, 95% CI 0·35-1·01; log-rank p=0·050). Median time to FACT-P total score deterioration was 14·8 months (95% CI 6·3-NE) with cabazitaxel and 8·9 months (6·3-NE) with abiraterone or enzalutamide (HR 0·72, 95% CI 0·44-1·20; log-rank p=0·21). There was a significant treatment effect seen in changes from baseline in EQ-5D-5L utility index score in favour of cabazitaxel over abiraterone or enzalutamide (p=0·030) but no difference between treatment groups for change from baseline in EQ-5D-5L visual analogue scale (p=0·060).
INTERPRETATION
Since cabazitaxel improved pain response, time to pain progression, time to symptomatic skeletal events, and EQ-5D-5L utility index, clinicians and patients with metastatic castration-resistant prostate cancer can be reassured that cabazitaxel will not reduce quality of life when compared with treatment with a second androgen signalling-targeted inhibitor.
FUNDING
Sanofi.",2020,"There was a significant treatment effect seen in changes from baseline in EQ-5D-5L utility index score in favour of cabazitaxel over abiraterone or enzalutamide (p=0·030) but no difference between treatment groups for change from baseline in EQ-5D-5L visual analogue scale (p=0·060).
","['Between Nov 17, 2015, and Nov 28, 2018, of 303 patients screened, 255 were randomly assigned to cabazitaxel (n=129) or', 'patients with metastatic castration-resistant prostate cancer', '62 clinical sites across 13 European countries', 'patients with metastatic prostate cancer', 'Patients (aged ≥18 years, Eastern Cooperative Oncology Group (ECOG) performance status ≤2) with confirmed metastatic castration-resistant prostate cancer', '111 patients with cabazitaxel and 21 (19%) of 109 patients with']","['interactive voice-web response system to receive cabazitaxel', 'abiraterone or enzalutamide', 'prednisone, and granulocyte colony-stimulating factor) versus abiraterone (1000 mg orally once daily plus 5 mg prednisone twice daily) or enzalutamide', 'docetaxel', 'cabazitaxel versus abiraterone or enzalutamide (CARD']","['EQ-5D-5L visual analogue scale (p=0·060', 'Median time to symptomatic skeletal events', 'radiographic progression-free survival', 'pain response, time to pain progression, time to symptomatic skeletal events, and EQ-5D-5L utility index', 'Median time to pain progression', 'pain (assessed using item 3 on the Brief Pain Inventory-Short Form [BPI-SF]) and symptomatic skeletal events, alongside preplanned patient-reported outcomes, assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and the EuroQoL-5 dimensions, 5 level scale (EQ-5D-5L', 'quality of life', 'Pain response', 'Quality of life', 'EQ-5D-5L utility index score', 'quality-of-life outcomes', 'radiographic progression-free survival and overall survival', 'Median time to FACT-P total score deterioration']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",255.0,0.285348,"There was a significant treatment effect seen in changes from baseline in EQ-5D-5L utility index score in favour of cabazitaxel over abiraterone or enzalutamide (p=0·030) but no difference between treatment groups for change from baseline in EQ-5D-5L visual analogue scale (p=0·060).
","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Department of Cancer Medicine, Institut Gustave Roussy and University of Paris Saclay, Villejuif, France. Electronic address: karim.fizazi@gustaveroussy.fr.'}, {'ForeName': 'Gero', 'Initials': 'G', 'LastName': 'Kramer', 'Affiliation': 'Department of Urology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Eymard', 'Affiliation': 'Institut Jean Godinot, Reims, France.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Englander Institute for Precision Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'de Bono', 'Affiliation': 'The Institute of Cancer Research and the Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': '12 de Octubre University Hospital, Madrid, Spain.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wülfing', 'Affiliation': 'Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Liontos', 'Affiliation': 'Department of Clinical Therapeutics, Oncology Unit, Alexandra Hospital, Athens, Greece.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Carles', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Iacovelli', 'Affiliation': 'Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy; Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic.'}, {'ForeName': 'Ásgerður', 'Initials': 'Á', 'LastName': 'Sverrisdóttir', 'Affiliation': 'Landspitali University Hospital, Reykjavik, Iceland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Theodore', 'Affiliation': 'Foch Hospital, Suresnes, France.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Feyerabend', 'Affiliation': 'Studienpraxis Urologie, Nürtingen, Germany.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Helissey', 'Affiliation': ""Hôpital d'Instruction des Armées BÉGIN, Saint Mandé, France.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Georges Pompidou European Hospital, Paris Descartes University, Paris, France.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Facchini', 'Affiliation': 'Istituto Nazionale Tumori-IRCCS-Fondazione, Naples, Italy.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Poole', 'Affiliation': 'Sanofi, Global Medical Oncology, Cambridge, MA, USA.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Ozatilgan', 'Affiliation': 'Sanofi, Global Medical Oncology, Cambridge, MA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Geffriaud-Ricouard', 'Affiliation': 'Sanofi, Europe Medical Oncology, Paris, France.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Bensfia', 'Affiliation': 'Sanofi, Europe Medical Oncology, Paris, France.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'de Wit', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30449-6']
2807,32936442,Soluble and insoluble fibers in ostrich nutrition: influences on growth performance and blood biochemical indices during different ages.,"This experiment was undertaken to evaluate the effects of different levels of soluble and insoluble fibers on growth performance and blood indices in ostrich at the age of 1 to 6 months. Thirty 30-day-old ostriches (males and females) were randomly assigned to five treatments with six replicates. There were five dietary treatments consisted of (1) basal diet; (2 and 3) diets containing 2 and 4% more soluble fibers (SF) than basal diet, and (4 and 5) diets containing 2 and 4% more insoluble fibers (ISF) than the basal diet. The dietary treatments had no significant influence on growth performance of ostriches. By increasing the levels of SF and ISF, the concentration of blood glucose (P < 0.0001) and high-density lipoprotein (HDL, P = 0.0046) increased, while the plasma concentration of triglyceride (P < 0.0001) and very-low-density lipoprotein (VLDL, P = 0.0006) decreased. The plasma enzyme activity of alanine aminotransferase (ALT) decreased in ostriches fed diet containing 4% more SF as compared with control (P < 0.0006). Body weight gain (BWG) at the starter phase (3-4 months) was higher than the pre-starter (1-2 months) and grower (5-6 months) phases (P < 0.0001). The highest concentration of blood glucose was observed at 2 months of age while the lowest magnitude was found at 4 months of age (P < 0.0001). The plasma cholesterol concentration increased at 4 months and decreased at 6 months as compared with 2 months (P < 0.0001). The concentration of HDL and LDL at 4 months of age was higher than two other ages (P < 0.0001). The blood concentration of triglyceride (P < 0.0001), VLDL (P < 0.0001), and ALT (P = 0.0005) decreased as ostriches grew up. It could be concluded that increasing the levels of soluble and insoluble fibers in the diet up to 4% more than previous recommendation may not have negative effects on growth performances and blood indices in ostrich.",2020,"The blood concentration of triglyceride (P < 0.0001), VLDL (P < 0.0001), and ALT (P = 0.0005) decreased as ostriches grew up.","['ostrich at the age of 1 to 6\xa0months', 'different ages', 'Thirty 30-day-old ostriches (males and females']","['basal diet; (2 and 3) diets containing 2 and 4% more soluble fibers (SF) than basal diet, and (4 and 5) diets containing 2 and 4% more insoluble fibers (ISF']","['highest concentration of blood glucose', 'blood concentration of triglyceride', 'plasma concentration of triglyceride', 'plasma enzyme activity of alanine aminotransferase (ALT', 'levels of SF and ISF, the concentration of blood glucose', 'Body weight gain (BWG', 'concentration of HDL and LDL', 'VLDL', 'growth performance and blood biochemical indices', 'growth performance of ostriches', 'high-density lipoprotein', 'plasma cholesterol concentration']","[{'cui': 'C0325336', 'cui_str': 'Struthio camelus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3661727', 'cui_str': 'Soluble fiber'}, {'cui': 'C3661726', 'cui_str': 'Insoluble fiber'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3661727', 'cui_str': 'Soluble fiber'}, {'cui': 'C3661726', 'cui_str': 'Insoluble fiber'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0325336', 'cui_str': 'Struthio camelus'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}]",,0.0308993,"The blood concentration of triglyceride (P < 0.0001), VLDL (P < 0.0001), and ALT (P = 0.0005) decreased as ostriches grew up.","[{'ForeName': 'Seyyed Mohammad', 'Initials': 'SM', 'LastName': 'Mirbehbahani', 'Affiliation': 'Department of Animal Science, College of Agriculture, University of Birjand, Amirabad Pardis, Birjand, South Khorasan, Islamic Republic of Iran.'}, {'ForeName': 'Seyyed Javad', 'Initials': 'SJ', 'LastName': 'Hosseini-Vashan', 'Affiliation': 'Department of Animal Science, College of Agriculture, University of Birjand, Amirabad Pardis, Birjand, South Khorasan, Islamic Republic of Iran. jhosseiniv@birjand.ac.ir.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mojtahedi', 'Affiliation': 'Department of Animal Science, College of Agriculture, University of Birjand, Amirabad Pardis, Birjand, South Khorasan, Islamic Republic of Iran.'}, {'ForeName': 'Seyyed Homayoun', 'Initials': 'SH', 'LastName': 'Farhangfar', 'Affiliation': 'Department of Animal Science, College of Agriculture, University of Birjand, Amirabad Pardis, Birjand, South Khorasan, Islamic Republic of Iran.'}, {'ForeName': 'Seyyed Abdollah', 'Initials': 'SA', 'LastName': 'Hosseini', 'Affiliation': 'Department of Animal Nutrition, Animal Science Research Institute, Karaj, Islamic Republic of Iran.'}]",Tropical animal health and production,['10.1007/s11250-020-02403-6']
2808,32936533,Bioequivalence and Pharmacokinetic Evaluation of Two Metformin Hydrochloride Tablets Under Fasting and Fed Conditions in Healthy Chinese Volunteers.,"This article aims to assess the bioequivalence of the test and the reference metformin hydrochloride tablets in healthy Chinese volunteers under fasting and fed conditions and to explore the effect of food on the pharmacokinetic (PK) profiles of both formulations. In total, 56 healthy Chinese subjects (28 in each group) were enrolled in this randomized, open, single-center, single-dose, 2-treatment, 2-sequence, 2-cycle cross clinical trial. The subjects were administrated a single dose of the test and the reference tablets at 0.25 g with a 7-day washout. Venous blood samples of all subjects were taken from predose 0 hour to postdose 24 hours according to the planned times. PK parameters for metformin were analyzed and calculated with noncompartmental methods. There were no significant differences in the PK parameters between the 2 formulations under both the fasting and the fed states. The 90% confidence intervals of 2 formulations were within 80.00%-125.00% based on C max , AUC 0-t , and AUC 0-∞ under both conditions. High-fat and high-calorie diets delayed the T max and reduced the AUC 0-t and AUC 0-∞ . No severe adverse events occurred in this study. Two metformin hydrochloride tablets were bioequivalent under both fasting and fed states; the high-fat and high-calorie diet could lower the rate and extent of absorption of metformin in healthy Chinese volunteers.",2020,High-fat and high-calorie diets delayed the T max and reduced the AUC 0-t and AUC 0-∞ .,"['Healthy Chinese Volunteers', 'healthy Chinese volunteers under fasting and fed conditions', '56 healthy Chinese subjects (28 in each group', 'healthy Chinese volunteers']","['metformin hydrochloride tablets', 'Metformin Hydrochloride Tablets', 'metformin hydrochloride']","['severe adverse events', 'Venous blood samples', 'PK parameters', 'rate and extent of absorption of metformin']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0770893', 'cui_str': 'Metformin hydrochloride'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]",56.0,0.0227836,High-fat and high-calorie diets delayed the T max and reduced the AUC 0-t and AUC 0-∞ .,"[{'ForeName': 'Xiao-Mei', 'Initials': 'XM', 'LastName': 'Huang', 'Affiliation': 'Department of Phase I Clinical Trial Research Center, XiangYa BoAi Rehabilitation Hospital, Changsha, China.'}, {'ForeName': 'Gong-Zhu', 'Initials': 'GZ', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacy, the Second XiangYa Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Bin-Bin', 'Initials': 'BB', 'LastName': 'He', 'Affiliation': 'Changsha Ruiyi Medical\xa0Technology Co., Ltd., Changsha, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Gao', 'Affiliation': 'Department of Phase I Clinical Trial Research Center, XiangYa BoAi Rehabilitation Hospital, Changsha, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Long', 'Affiliation': 'Chongqing Kerui Pharmaceutical (Group) Co., Ltd., Chongqing, China.'}, {'ForeName': 'Bi-Kui', 'Initials': 'BK', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, the Second XiangYa Hospital of Central South University, Changsha, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.849']
2809,32933339,Empirical power comparison of statistical tests in contemporary phase III randomized controlled trials with time-to-event outcomes in oncology.,"BACKGROUND
More than 95% of recent cancer randomized controlled trials used the log-rank test to detect a treatment difference making it the predominant tool for comparing two survival functions. As with other tests, the log-rank test has both advantages and disadvantages. One advantage is that it offers the highest power against proportional hazards differences, which may be a major reason why alternative methods have rarely been employed in practice. The performance of statistical tests has traditionally been investigated both theoretically and numerically for several patterns of difference between two survival functions. However, to the best of our knowledge, there has been no attempt to compare the performance of various statistical tests using empirical data from past oncology randomized controlled trials. So, it is unknown whether the log-rank test offers a meaningful power advantage over alternative testing methods in contemporary cancer randomized controlled trials. Focusing on recently reported phase III cancer randomized controlled trials, we assessed whether the log-rank test gave meaningfully greater power when compared with five alternative testing methods: generalized Wilcoxon, test based on maximum of test statistics from multiple weighted log-rank tests, difference in t -year event rate, and difference in restricted mean survival time with fixed and adaptive τ .
METHODS
Using manuscripts from cancer randomized controlled trials recently published in high-tier clinical journals, we reconstructed patient-level data for overall survival (69 trials) and progression-free survival (54 trials). For each trial endpoint, we estimated the empirical power of each test. Empirical power was measured as the proportion of trials for which a test would have identified a significant result ( p value < .05).
RESULTS
For overall survival, t -year event rate offered the lowest (30.4%) empirical power and restricted mean survival time with fixed τ offered the highest (43.5%). The empirical power of the other types of tests was almost identical (36.2%-37.7%). For progression-free survival, the tests we investigated offered numerically equivalent empirical power (55.6%-61.1%). No single test consistently outperformed any other test.
CONCLUSION
The empirical power assessment with the past cancer randomized controlled trials provided new insights on the performance of statistical tests. Although the log-rank test has been used in almost all trials, our study suggests that the log-rank test is not the only option from an empirical power perspective. Near universal use of the log-rank test is not supported by a meaningful difference in empirical power. Clinical trial investigators could consider alternative methods, beyond the log-rank test, for their primary analysis when designing a cancer randomized controlled trial. Factors other than power (e.g. interpretability of the estimated treatment effect) should garner greater consideration when selecting statistical tests for cancer randomized controlled trials.",2020,The empirical power of the other types of tests was almost identical (36.2%-37.7%).,"['Using manuscripts from cancer randomized controlled trials recently published in high-tier clinical journals, we reconstructed patient-level data for overall survival (69 trials) and progression-free survival (54 trials']",[],"['mean survival time', 'mean survival time with fixed and adaptive τ ', 'overall survival']","[{'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",[],"[{'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.282187,The empirical power of the other types of tests was almost identical (36.2%-37.7%).,"[{'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Horiguchi', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hassett', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Uno', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520940256']
2810,32936680,Effects of sex and menstrual cycle on volume-regulatory responses to 24-h fluid restriction.,"Reproductive hormones have significant nonreproductive physiological effects, including altering fluid regulation. Our purpose was to explore the impact of sex and menstrual cycle (MC) phase on volume-regulatory responses to 24-h fluid restriction (24-h FR). Participants (men: n = 12, 20 ± 2 yr; women: n = 10, 20 ± 1 yr) were assigned two randomized and counterbalanced fluid prescriptions [Euhy: euhydrated, urine specific gravity (USG) < 1.020; Dehy: 24-h FR, USG > 1.020]. Men completed both (MEuhy, MDehy), while women completed both in the late-follicular ( days 10-13 ; FDehy, FEuhy) and midluteal ( days 18-22 ; LDehy, LEuhy) phases. We measured body mass, plasma and urine osmolality (P osm , U osm ), urine specific gravity (USG), urine color (U col ), and serum copeptin; 24-h FR yielded mild dehydration without influence of sex or MC ( P > 0.05). Copeptin increased in men following Dehy (pre: 8.2 ± 5.2, post: 15.8 ± 12.6, P = 0.04) but not in women (FDehy pre: 4.3 ± 1.6, post: 10.5 ± 6.9, P = 0.06; LDehy pre: 5.6 ± 3.5, post: 10.4 ± 6.2, P = 0.16). In FDehy, P osm increased following FR (pre: 288 ± 2, post: 292 ± 1, P = 0.03) but not in men (pre: 292 ± 3, post: 293 ± 2, P = 0.46). No MC differences were observed between body mass loss, P osm , U osm , USG, and copeptin ( P > 0.05). These results suggest that volume-regulatory responses to 24-h FR were present in men but not in women, without apparent effects of the menstrual cycle.",2020,"Men exhibited higher copeptin following Dehy (pre: 8.2±5.2, post: 15.8±12.6, P=0.04) but women did not (FDehy - pre: 4.3±1.6, post: 10.5±6.9, P=0.06; LDehy - pre: 5.6±3.5, post: 10.4±6.2, P=0.16).","['young healthy adults', 'Participants (men: n=12, 20±2y; women: n=10, 20±1y']",['24-hour fluid restriction (24-h FR'],"['body mass, plasma and urine osmolality (P osm , U osm ), USG, urine color (U col ) and serum copeptin', 'BML, P osm , U osm , USG, U col , and serum copeptin']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0204700', 'cui_str': 'Fluid restriction'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0740085', 'cui_str': 'Osmolality measurement, urine'}, {'cui': 'C0439186', 'cui_str': 'osmol'}, {'cui': 'C0278030', 'cui_str': 'Color of urine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}]",,0.0971306,"Men exhibited higher copeptin following Dehy (pre: 8.2±5.2, post: 15.8±12.6, P=0.04) but women did not (FDehy - pre: 4.3±1.6, post: 10.5±6.9, P=0.06; LDehy - pre: 5.6±3.5, post: 10.4±6.2, P=0.16).","[{'ForeName': 'Gabrielle E W', 'Initials': 'GEW', 'LastName': 'Giersch', 'Affiliation': 'United States Army Research Institute for Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Abigail T', 'Initials': 'AT', 'LastName': 'Colburn', 'Affiliation': 'Arizona State University, Hydration Science Laboratory, Phoenix, Arizona.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Morrissey', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Cody R', 'Initials': 'CR', 'LastName': 'Butler', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Michaela L', 'Initials': 'ML', 'LastName': 'Pruchnicki', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Stavros A', 'Initials': 'SA', 'LastName': 'Kavouras', 'Affiliation': 'Arizona State University, Hydration Science Laboratory, Phoenix, Arizona.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Charkoudian', 'Affiliation': 'United States Army Research Institute for Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Casa', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, Connecticut.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00173.2020']
2811,32936713,Randomized Controlled Trial of Trastuzumab With or Without Chemotherapy for HER2-Positive Early Breast Cancer in Older Patients.,"PURPOSE
Adjuvant trastuzumab monotherapy has not been compared with trastuzumab + chemotherapy. We investigated the relative value of trastuzumab monotherapy for older patients with breast cancer.
METHODS
This study was an open-label, randomized controlled study with a treatment selection design in which a noninferiority criterion was predefined. Patients aged 70-80 years with surgically treated human epidermal growth factor receptor 2-positive invasive breast cancer received trastuzumab monotherapy or trastuzumab + chemotherapy. The primary end point was disease-free survival (DFS) with assessment of prespecified hazard ratio (HR), relapse-free survival (RFS), adverse events (AEs), health-related quality of life (HRQoL), and restricted mean survival time (RMST).
RESULTS
The study involved 275 patients (mean age, 73.5 years) who were followed up for a mean of 4.1 years (range, 0.3-8.0 years). The percentages of patients by cancer stage were as follows: I (pT > 0.5 cm), 43.6%; IIA, 41.7%; IIB, 13.5%; and IIIA, 1.1%. Three-year DFS was 89.5% with trastuzumab monotherapy versus 93.8% with trastuzumab + chemotherapy (HR, 1.36; 95% CI, 0.72 to 2.58; P = .51). At 3 years, RMST differed by -0.39 months between arms (95% CI, -1.71 to 0.93; P = .56). Three-year RFS was 92.4% with trastuzumab monotherapy versus 95.3% with trastuzumab + chemotherapy (HR, 1.33; 95% CI, 0.63 to 2.79; P = .53). Common AEs were anorexia (7.4% v 44.3%; P < .0001) and alopecia (2.2% v 71.7%; P < .0001), and grade 3/4 nonhematologic AEs occurred in 11.9% versus 29.8% ( P = .0003) for trastuzumab monotherapy versus trastuzumab + chemotherapy, respectively. Clinically meaningful HRQoL deterioration rate showed significant differences at 2 months (31% for trastuzumab monotherapy v 48% for trastuzumab + chemotherapy; P = .016) and at 1 year (19% v 38%; P = .009).
CONCLUSION
The primary objective of noninferiority for trastuzumab monotherapy was not met. However, the observed loss of survival without chemotherapy was < 1 month at 3 years. Therefore, and in light of the lower toxicity and more favorable HRQoL profile, trastuzumab monotherapy can be considered an adjuvant therapy option for selected older patients.",2020,"Clinically meaningful HRQoL deterioration rate showed significant differences at 2 months (31% for trastuzumab monotherapy v 48% for trastuzumab + chemotherapy; P = .016) and at 1 year (19% v 38%; P = .009).
","['Patients aged 70-80 years with surgically treated human epidermal growth factor receptor 2-positive invasive breast cancer received', '275 patients (mean age, 73.5 years) who were followed up for a mean of 4.1 years (range, 0.3-8.0 years', 'selected older patients', 'older patients with breast cancer', 'HER2-Positive Early Breast Cancer in Older Patients']","['trastuzumab monotherapy or trastuzumab + chemotherapy', 'trastuzumab + chemotherapy', 'Trastuzumab With or Without Chemotherapy', 'trastuzumab monotherapy']","['anorexia', 'grade 3/4 nonhematologic AEs', 'Clinically meaningful HRQoL deterioration rate', 'alopecia', 'disease-free survival (DFS) with assessment of prespecified hazard ratio (HR), relapse-free survival (RFS), adverse events (AEs), health-related quality of life (HRQoL), and restricted mean survival time (RMST']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}]",275.0,0.182377,"Clinically meaningful HRQoL deterioration rate showed significant differences at 2 months (31% for trastuzumab monotherapy v 48% for trastuzumab + chemotherapy; P = .016) and at 1 year (19% v 38%; P = .009).
","[{'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Sawaki', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Naruto', 'Initials': 'N', 'LastName': 'Taira', 'Affiliation': 'Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'Biostatistics Section, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Department of Surgery, Japanese Red Cross Saitama Hospital, Saitama, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Baba', 'Affiliation': 'Department of Surgery, Sagara Hospital, Kagoshima, Japan.'}, {'ForeName': 'Kokoro', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Medical Oncology, the Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Surgery, Aomori City Hospital, Aomori, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Tsuneizumi', 'Affiliation': 'Department of Breast Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Sagawa', 'Affiliation': 'Department of Breast Surgery, Kameda Medical Center, Kamogawa, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Bando', 'Affiliation': 'Department of Breast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Breast Surgery, JCHO Kurume General Hospital, Kurume, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takashima', 'Affiliation': 'Department of Breast and Endocrine Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Nakayama', 'Affiliation': 'Department of Breast and Endocrine Surgery, Osaka International Cancer Institute, Osaka Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kashiwaba', 'Affiliation': 'Department of Surgery, Sagara Hospital, Kagoshima, Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Mizuno', 'Affiliation': 'Department of Medical Oncology, Mie University Hospital, Tsu, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Breast and Endocrine Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Kawahara', 'Affiliation': 'Biostatistics Division, Clinical Research Support Center, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00184']
2812,32958537,The cost-effectiveness of using performance-based financing to deliver the basic package of health services in Afghanistan.,"Performance-based financing (PBF) is a mechanism to improve the quality and the utilisation of health benefit packages. There is a dearth of economic evaluations of PBF in the 'real world'. Afghanistan implemented PBF between 2010 and 2015 and evaluated the programme using a pragmatic cluster-randomised control trial. We conducted a cost-effectiveness analysis of the PBF programme in Afghanistan, compared with the standard of care, from the provider payer's perspective. The incremental cost-effectiveness ratio of PBF compared with the standard of care was US$1242 per disability-adjusted life year averted; not cost-effective when compared with an opportunity cost threshold of US$349. Incentive payments were the main contributor to PBF financial cost (70%) followed by data verification (23%), staff time (5%) and administration (2%). The unit cost per case of antenatal care (ANC), skilled birth attendance (SBA) and postnatal care (PNC) services in the standard of care was US$0.96 (95% CI 0.92-1.0), US$4.8 (95% CI 4.1-6.3) and US$1.3 (95% CI 1.2-1.4), respectively, whereas the cost of ANC, SBA and PNC services per case in PBF areas were US$4.72 (95% CI 4.68-5.7), US$48.5 (95% CI 48.0-52.5) and US$5.4 (95% CI 5.1-5.9), respectively. To conclude, our study found that PBF, as implemented in the Afghan context, was not the best use of funds to strengthen the delivery of maternal and child health services. The cost-effectiveness of alternative PBF designs needs to be appraised before using PBF at scale to support health benefit packages. PBF needs to be considered in the context of funding the range of constraints that inhibit health service performance improvement.",2020,"Incentive payments were the main contributor to PBF financial cost (70%) followed by data verification (23%), staff time (5%) and administration (2%).",['Afghanistan'],"['PBF programme', 'Performance-based financing (PBF']","['cost-effectiveness', 'unit cost per case of antenatal care (ANC), skilled birth attendance (SBA) and postnatal care (PNC) services', 'staff time', 'incremental cost-effectiveness ratio of PBF', 'cost of ANC, SBA and PNC services per case in PBF areas', 'PBF financial cost']","[{'cui': 'C0001732', 'cui_str': 'Afghanistan'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243097', 'cui_str': 'financing'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243097', 'cui_str': 'financing'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0376243', 'cui_str': 'finances'}]",,0.0615825,"Incentive payments were the main contributor to PBF financial cost (70%) followed by data verification (23%), staff time (5%) and administration (2%).","[{'ForeName': 'Ahmad S', 'Initials': 'AS', 'LastName': 'Salehi', 'Affiliation': 'Department of Global Health Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, London, UK ahmad.salehi@lshtm.ac.uk.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Borghi', 'Affiliation': 'Department of Global Health Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Blanchet', 'Affiliation': 'Centre for Education and Research in Humanitarian Action (CERAH), University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vassall', 'Affiliation': 'Department of Global Health Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, London, UK.'}]",BMJ global health,['10.1136/bmjgh-2020-002381']
2813,32961119,"Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial.","BACKGROUND
Previously, findings from CheckMate 238, a double-blind, phase 3 adjuvant trial in patients with resected stage IIIB-C or stage IV melanoma, showed significant improvements in recurrence-free survival and distant metastasis-free survival with nivolumab versus ipilimumab. This report provides updated 4-year efficacy, initial overall survival, and late-emergent safety results.
METHODS
This multicentre, double-blind, randomised, controlled, phase 3 trial was done in 130 academic centres, community hospitals, and cancer centres across 25 countries. Patients aged 15 years or older with resected stage IIIB-C or IV melanoma and an Eastern Cooperative Oncology Group performance status of 0 or 1 were randomly assigned (1:1) to receive nivolumab or ipilimumab via an interactive voice response system and stratified according to disease stage and baseline PD-L1 status of tumour cells. Patients received intravenous nivolumab 3 mg/kg every 2 weeks or intravenous ipilimumab 10 mg/kg every 3 weeks for four doses, and then every 12 weeks until 1 year of treatment, disease recurrence, unacceptable toxicity, or withdrawal of consent. The primary endpoint was recurrence-free survival by investigator assessment, and overall survival was a key secondary endpoint. Efficacy analyses were done in the intention-to-treat population (all randomly assigned patients). All patients who received at least one dose of study treatment were included in the safety analysis. The results presented in this report reflect the 4-year update of the ongoing study with a database lock date of Jan 30, 2020. This study is registered with ClinicalTrials.gov, NCT02388906.
FINDINGS
Between March 30 and Nov 30, 2015, 906 patients were assigned to nivolumab (n=453) or ipilimumab (n=453). Median follow-up was 51·1 months (IQR 41·6-52·7) with nivolumab and 50·9 months (36·2-52·3) with ipilimumab; 4-year recurrence-free survival was 51·7% (95% CI 46·8-56·3) in the nivolumab group and 41·2% (36·4-45·9) in the ipilimumab group (hazard ratio [HR] 0·71 [95% CI 0·60-0·86]; p=0·0003). With 211 (100 [22%] of 453 patients in the nivolumab group and 111 [25%] of 453 patients in the ipilimumab group) of 302 anticipated deaths observed (about 73% of the originally planned 88% power needed for significance), 4-year overall survival was 77·9% (95% CI 73·7-81·5) with nivolumab and 76·6% (72·2-80·3) with ipilimumab (HR 0·87 [95% CI 0·66-1·14]; p=0·31). Late-emergent grade 3-4 treatment-related adverse events were reported in three (1%) of 452 and seven (2%) of 453 patients. The most common late-emergent treatment-related grade 3 or 4 adverse events reported were diarrhoea, diabetic ketoacidosis, and pneumonitis (one patient each) in the nivolumab group, and colitis (two patients) in the ipilimumab group. Two previously reported treatment-related deaths in the ipilimumab group were attributed to study drug toxicity (marrow aplasia in one patient and colitis in one patient); no further treatment-related deaths were reported.
INTERPRETATION
At a minimum of 4 years' follow-up, nivolumab demonstrated sustained recurrence-free survival benefit versus ipilimumab in resected stage IIIB-C or IV melanoma indicating a long-term treatment benefit with nivolumab. With fewer deaths than anticipated, overall survival was similar in both groups. Nivolumab remains an efficacious adjuvant treatment for patients with resected high-risk melanoma, with a safety profile that is more tolerable than that of ipilimumab.
FUNDING
Bristol Myers Squibb and Ono Pharmaceutical.",2020,"At a minimum of 4 years' follow-up, nivolumab demonstrated sustained recurrence-free survival benefit versus ipilimumab in resected stage IIIB-C or IV melanoma indicating a long-term treatment benefit with nivolumab.","['resected stage IIIB-C and stage IV melanoma (CheckMate 238', 'Patients aged 15 years or older with resected stage IIIB-C or IV melanoma and an Eastern Cooperative Oncology Group performance status of 0 or 1', '130 academic centres, community hospitals, and cancer centres across 25 countries', 'Between March 30 and Nov 30, 2015', '906 patients were assigned to nivolumab (n=453) or', 'patients with resected stage IIIB-C or stage IV melanoma', 'patients with resected high-risk melanoma']","['intravenous nivolumab 3 mg/kg every 2 weeks or intravenous ipilimumab', 'nivolumab or ipilimumab', 'ipilimumab', 'Adjuvant nivolumab versus ipilimumab', 'Nivolumab']","['sustained recurrence-free survival benefit', 'recurrence-free survival by investigator assessment, and overall survival', 'deaths', 'adverse events', 'drug toxicity (marrow aplasia', '4-year overall survival', 'recurrence-free survival', 'diarrhoea, diabetic ketoacidosis, and pneumonitis', 'overall survival', 'recurrence-free survival and distant metastasis-free survival']","[{'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013221', 'cui_str': 'Poisoning by drug AND/OR medicinal substance'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0000846', 'cui_str': 'Agenesis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",906.0,0.794635,"At a minimum of 4 years' follow-up, nivolumab demonstrated sustained recurrence-free survival benefit versus ipilimumab in resected stage IIIB-C or IV melanoma indicating a long-term treatment benefit with nivolumab.","[{'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy. Electronic address: paolo.ascierto@gmail.com.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Del Vecchio', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandalá', 'Affiliation': 'Papa Giovanni XIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gogas', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Arance', 'Affiliation': 'Hospital Clínic de Barcelona-IDIBAPS, Barcelona, Spain.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Hospices Civils de Lyon, Pierre Bénite, France.'}, {'ForeName': 'C Lance', 'Initials': 'CL', 'LastName': 'Cowey', 'Affiliation': 'Texas Oncology-Baylor Charles A Sammons Cancer Center, Dallas, TX, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schenker', 'Affiliation': 'Oncology Center Sf Nectarie, Craiova, Romania.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Department of Dermatology, Aix-Marseille University, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Márquez-Rodas', 'Affiliation': 'Department of Medical Oncology, General University Hospital Gregorio Marañón and CIBERONC, Madrid, Spain.'}, {'ForeName': 'Marcus O', 'Initials': 'MO', 'LastName': 'Butler', 'Affiliation': 'Department of Immuno-oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maio', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'Department of Oncology, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'de la Cruz-Merino', 'Affiliation': 'Department of Clinical Oncology, Hospital University Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Arenberger', 'Affiliation': 'Department of Dermatology, Charles University Third Faculty of Medicine and University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'Division of Cancer Services, Gallipoli Medical Research Foundation, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Medical Oncology, Tasman Health Care, Southport, QLD, Australia.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Fecher', 'Affiliation': 'Department of Medical Oncology, Internal Medicine, University of Michigan Rogel Cancer Center, Ann Arbor, MI, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Millward', 'Affiliation': 'Department of Internal Medicine, University of Western Australia and Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'Nikhil I', 'Initials': 'NI', 'LastName': 'Khushalani', 'Affiliation': 'Department of Cutaneous Oncology, H Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Queirolo', 'Affiliation': 'IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Lobo', 'Affiliation': 'Oncology Clinical Development, Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'de Pril', 'Affiliation': 'Department of Global Regulatory and Safety Sciences, Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Loffredo', 'Affiliation': 'Clinical Biomarkers, Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Department of Medical Oncology, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Weber', 'Affiliation': 'Laura and Isaac Perlmutter Cancer Center, NYU Langone Health, New York, NY, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30494-0']
2814,32962569,Effects of osteoblast autophagy on glucocorticoid-induced femoral head necrosis.,"OBJECTIVES
This study aims to explore the mechanism by which osteoblast autophagy participated in glucocorticoid-induced femoral head necrosis (FHN).
MATERIALS AND METHODS
Thirty male specific-pathogen-free C57 mice (age, one month; weighing 20-25 g) were randomly divided into blank control, dexamethasone and rapamycin-dexamethasone groups (n=10). After six weeks of intervention, right femoral head was obtained to observe morphology and to calculate percentage of empty lacunae. MC3T3-E1 cells were randomly divided into normal, dexamethasone, rapamycin and dexamethasone-rapamycin groups, and cultured for 24 h. Microtubule-associated protein 1 light chain 3 (LC3)-I, LC3-II, mammalian target of rapamycin (mTOR) and Beclin-1 protein expressions were detected by Western blot.
RESULTS
In rapamycin-dexamethasone group, some bone trabeculae in medullary cavity ruptured and atrophied, and subchondral bone underwent local necrosis. The total apoptosis rates of dexamethasone and rapamycin-dexamethasone groups surpassed that of blank control group, and the former two groups had significantly different rates (p<0.001). LC3-II/LC3-I of dexamethasone group was lower than those of rapamycin and dexamethasone-rapamycin groups (p<0.001), and the ratio of rapamycin group surpassed that of dexamethasone-rapamycin group (p<0.001). Dexamethasone group had higher mTOR protein expression than those of rapamycin and dexamethasone- rapamycin groups (p<0.001), and the expression of rapamycin group was lower than that of dexamethasone-rapamycin group (p<0.001). The Beclin-1 protein expression of dexamethasone group was lower than those of rapamycin and dexamethasone- rapamycin groups (p<0.001), and the expression of rapamycin group exceeded that of dexamethasone-rapamycin group (p<0.05).
CONCLUSION
Osteoblast autophagy may play a crucial protective role in dexamethasone-induced FHN. The attenuation of autophagy may be related to the affected expressions of key autophagy regulators mTOR and Beclin-1.",2020,"Dexamethasone group had higher mTOR protein expression than those of rapamycin and dexamethasone- rapamycin groups (p<0.001), and the expression of rapamycin group was lower than that of dexamethasone-rapamycin group (p<0.001).","['Thirty male specific-pathogen-free C57 mice (age, one month; weighing 20-25 g', 'groups (n=10']","['blank control, dexamethasone and rapamycin-dexamethasone', 'dexamethasone and rapamycin-dexamethasone', 'rapamycin and dexamethasone- rapamycin', 'dexamethasone-rapamycin', 'dexamethasone', 'rapamycin and dexamethasone-rapamycin', 'Dexamethasone', 'rapamycin-dexamethasone', 'dexamethasone, rapamycin and dexamethasone-rapamycin groups, and cultured for 24 h. Microtubule-associated protein 1 light chain 3 (LC3)-I, LC3-II, mammalian target of rapamycin (mTOR']","['Beclin-1 protein expression', 'total apoptosis rates', 'mTOR protein expression']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0162470', 'cui_str': 'Specific Pathogen Free'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0026045', 'cui_str': 'Microtubule Associated Proteins'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0293060', 'cui_str': 'FKBP12-Rapamycin Associated Protein'}]","[{'cui': 'C4255099', 'cui_str': 'Beclin-1 Protein'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0293060', 'cui_str': 'FKBP12-Rapamycin Associated Protein'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",30.0,0.0197136,"Dexamethasone group had higher mTOR protein expression than those of rapamycin and dexamethasone- rapamycin groups (p<0.001), and the expression of rapamycin group was lower than that of dexamethasone-rapamycin group (p<0.001).","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Yaozeng', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopedics, First Affiliated Hospital of Soochow University, Suzhou 215006, Jiangsu Province, People's Republic of China. xuyzfahsu@aliyun.com.""}, {'ForeName': 'Jiannong', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Chenjun', 'Initials': 'C', 'LastName': 'Zhai', 'Affiliation': ''}]",Joint diseases and related surgery,['10.5606/ehc.2020.73036']
2815,32962591,Does mini-midvastus approach have an advantageous effect on rapid recovery protocols over medial parapatellar approach in total knee arthroplasty?,"OBJECTIVES
This study aims to compare the effects of mini-midvastus (MMV) versus medial parapatellar (MPP) approach on rapid recovery protocols during total knee arthroplasty (TKA).
PATIENTS AND METHODS
This prospective, randomized, single-blinded study was performed in 54 patients (4 males, 50 females; mean age 64.1±6.4 years) diagnosed as primary knee osteoarthritis and planned for unilateral TKA between May 2018 and March 2019. Patients were randomly assigned as MMV (1 male, 26 females; mean age 65±6.4 years) and MPP (3 males, 24 females; mean age 63.2±6.3 years) groups. Rapid recovery TKA protocol and discharge criteria were assembled and all patients were evaluated preoperatively, and at postoperative first and third months. Length of hospital stay (LOS) was recorded for all patients. Hemoglobin and hematocrit values, radiologic assessment of alignment, knee range of motion (ROM), quadriceps muscle strength, visual analog scale (VAS), 30-sec chair-stand test, stair-climb test, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS), and Short Form-36 (SF-36) were used for evaluations by blinded observers.
RESULTS
There was no significant difference in demographic variables between two groups. Operative time in MMV Group (78.1±2.7 min) was significantly longer than the MPP Group (65.9±2.6 min) (p<0.0005). LOSs in the MMV and MPP Groups were 27.6±3.1 hours and 29.1±6.7 hours with no significant difference. There was no statistically significant difference in postoperative measurements between groups in hemoglobin and hematocrit values, radiologic alignment of components, knee ROM, VAS, 30-sec chair-stand test, stair-climb test, WOMAC, KOOS, and SF-36 evaluations (p>0.05). In terms of quadriceps muscle strength gain, we could not find any difference between groups in pre- and postoperative difference of changes (p>0.05).
CONCLUSION
With the use of contemporary rapid recovery protocols during TKA, MMV approach had no superiority over MPP approach when quadriceps muscle strength, LOS, pain, function, and quality of life were assessed. Longer operative time in the MMV approach compared to MPP approach may be considered as a disadvantage.",2020,"In terms of quadriceps muscle strength gain, we could not find any difference between groups in pre- and postoperative difference of changes (p>0.05).
","['total knee arthroplasty (TKA', '54 patients (4 males, 50 females; mean age 64.1±6.4 years) diagnosed as primary knee osteoarthritis and planned for unilateral TKA between May 2018 and March 2019', '1 male, 26 females; mean age 65±6.4 years) and MPP (3 males, 24 females; mean age 63.2±6.3 years) groups']","['mini-midvastus (MMV) versus medial parapatellar (MPP) approach', 'MPP', 'MMV', 'TKA']","['demographic variables', 'Hemoglobin and hematocrit values, radiologic assessment of alignment, knee range of motion (ROM), quadriceps muscle strength, visual analog scale (VAS), 30-sec chair-stand test, stair-climb test, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS), and Short Form-36 (SF-36', 'LOSs', 'Longer operative time', 'quadriceps muscle strength, LOS, pain, function, and quality of life', 'Operative time', 'Rapid recovery TKA protocol and discharge criteria', 'hemoglobin and hematocrit values, radiologic alignment of components, knee ROM, VAS, 30-sec chair-stand test, stair-climb test, WOMAC, KOOS, and SF-36 evaluations (p>0.05', 'Length of hospital stay (LOS', 'postoperative measurements']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0442141', 'cui_str': 'Medial parapatellar approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0442141', 'cui_str': 'Medial parapatellar approach'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",54.0,0.0968514,"In terms of quadriceps muscle strength gain, we could not find any difference between groups in pre- and postoperative difference of changes (p>0.05).
","[{'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Zora', 'Affiliation': ''}, {'ForeName': 'Harun R', 'Initials': 'HR', 'LastName': 'Güngör', 'Affiliation': 'Pamukkale Üniversitesi Tıp Fakültesi Ortopedi ve Travmatoloji Anabilim Dalı, 20070 Pamukkale, Denizli, Türkiye. hrgungor@gmail.com.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Bayrak', 'Affiliation': ''}, {'ForeName': 'Raziye', 'Initials': 'R', 'LastName': 'Şavkın', 'Affiliation': ''}, {'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Büker', 'Affiliation': ''}]",Joint diseases and related surgery,['10.5606/ehc.2020.76387']
2816,32962593,Effects of intraarticular ketamine combined with periarticular bupivacaine on postoperative pain after arthroscopic meniscectomy.,"OBJECTIVES
This study aims to evaluate the effects of two different doses of intraarticular ketamine on visual analog scale (VAS) scores at rest and movement, time to first analgesic requirement, and 24-h morphine consumption in patients undergoing arthroscopic meniscectomy as well as to assess the frequency of postoperative nausea&vomiting, respiratory depression, pruritus, urinary retention, and constipation and to compare the time to discharge.
PATIENTS AND METHODS
This prospective randomized double-blind study was performed between August 2013 and August 2014 on 75 patients (32 males, 43 females; mean age 46.7±13 years; range, 18 to 75 years) with American Society of Anesthesiologists scores of I-II scheduled for unilateral meniscectomy. Patients were randomized to receive 0.5 mg.kg -1 ketamine (group K1), 1 mg.kg -1 ketamine (group K2) or saline (group S) to a total volume of 20 mL intraarticularly at the end of the surgery. All patients were performed periarticular 10 mL 0.5% bupivacaine infiltration. Visual analog scale at rest and during passive knee movement was used to evaluate pain both preoperatively and at postoperative 0, 30 min, and 1, 2, 4, 6, 12, and 24 h. Time to first analgesic requirement and morphine consumption were recorded.
RESULTS
Visual analog scale scores at rest and during movement at postoperative 0 were significantly reduced in group K2 compared with group S (p<0.05). The first analgesic requirement time was significantly longer in group K1 (76.9±25.2 min) and group K2 (93.4±26.1 min) than group S (29.3±7.1 min). Morphine consumption was lower in group K2 compared to group K1 and group S at postoperative 30 min, and 1 and 2 h. However, 24-h morphine consumption was similar in all groups.
CONCLUSION
Intraarticular injection of 0.5 mg.kg -1 and 1 mg.kg -1 ketamine for postoperative pain management provided similar analgesic efficacy. However, high dose ketamine more noticeably decreased opioid requirement in the early postoperative period.",2020,"Morphine consumption was lower in group K2 compared to group K1 and group S at postoperative 30 min, and 1 and 2 h.","['August 2013 and August 2014 on 75 patients (32 males, 43 females; mean age 46.7±13 years; range, 18 to 75 years) with American Society of Anesthesiologists scores of I-II scheduled for unilateral meniscectomy', 'patients undergoing arthroscopic meniscectomy', 'after arthroscopic meniscectomy']","['bupivacaine', 'ketamine (group K2) or saline', 'ketamine', 'intraarticular ketamine combined with periarticular bupivacaine', 'intraarticular ketamine']","['Visual analog scale scores', 'opioid requirement', 'visual analog scale (VAS) scores at rest and movement, time to first analgesic requirement, and 24-h morphine consumption', 'analgesic requirement time', 'analgesic efficacy', 'Visual analog scale', 'Morphine consumption', '24-h morphine consumption', 'postoperative pain', 'frequency of postoperative nausea&vomiting, respiratory depression, pruritus, urinary retention, and constipation and to compare the time to discharge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.0814667,"Morphine consumption was lower in group K2 compared to group K1 and group S at postoperative 30 min, and 1 and 2 h.","[{'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Sağır', 'Affiliation': 'Balıkesir Üniversitesi Tıp Fakültesi Anesteziyoloji ve Reanimasyon Anabilim Dalı, 10145 Bigadiç, Balıkesir, Türkiye. ozlemsagir@yahoo.com.'}, {'ForeName': 'Betül', 'Initials': 'B', 'LastName': 'Tatar', 'Affiliation': ''}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Ugün', 'Affiliation': ''}, {'ForeName': 'Hafize Fisun', 'Initials': 'HF', 'LastName': 'Demir', 'Affiliation': ''}, {'ForeName': 'Ayşe Neslihan', 'Initials': 'AN', 'LastName': 'Balkaya', 'Affiliation': ''}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Meriç', 'Affiliation': ''}, {'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Kocaoğlu', 'Affiliation': ''}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Köroğlu', 'Affiliation': ''}]",Joint diseases and related surgery,['10.5606/ehc.2020.75274']
2817,32964776,Greater Occipital Nerve Stimulation Boosts Associative Memory in Older Individuals: A Randomized Trial.,"Transcutaneous electrical stimulation (tES) is a new approach that aims to stimulate the brain. Recently, we have developed tES approaches to enhance plasticity that modulate cortical activity via the greater occipital nerve (ON) in a ""bottom-up"" way. Thirty subjects between the ages of 55 and 70 years were enrolled and tested using a double-blind, sham-controlled, and randomized design. Half of the participants received active stimulation, while the other half received sham stimulation. Our results demonstrate that ON-tES can enhance memory in older individuals after one session, with effects persisting up to 28 days after stimulation. The hypothesized mechanism by which ON-tES enhances memory is activation of the locus coeruleus-noradrenaline (LC-NA) pathway. It is likely that this pathway was activated after ON-tES, as supported by observed changes in α-amylase concentrations, a biomarker for noradrenaline. There were no significant or long-lasting side effects observed during stimulation. Clinicaltrial.gov (NCT03467698).",2020,There were no significant or long-lasting side effects observed during stimulation.,"['Thirty subjects between the ages of 55 and 70 years', 'Older Individuals']","['Transcutaneous electrical stimulation (tES', 'Greater Occipital Nerve Stimulation Boosts Associative Memory', 'ON-tES']",['long-lasting side effects'],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0228814', 'cui_str': 'Greater occipital nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C1283707', 'cui_str': 'Occipital nerve'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",30.0,0.221199,There were no significant or long-lasting side effects observed during stimulation.,"[{'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Luckey', 'Affiliation': 'Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'S Lauren', 'Initials': 'SL', 'LastName': 'McLeod', 'Affiliation': 'University of Texas at Dallas, Richardson, TX, USA.'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'Robertson', 'Affiliation': 'Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Wing Ting', 'Initials': 'WT', 'LastName': 'To', 'Affiliation': 'Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Vanneste', 'Affiliation': 'Trinity College Dublin, Dublin, Ireland.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320943573']
2818,32966683,Sperm DNA methylation changes after short-term nut supplementation in healthy men consuming a Western-style diet.,"BACKGROUND
Many environmental and lifestyle factors have been implicated in the decline of sperm quality, with diet being one of the most plausible factors identified in recent years. Moreover, several studies have reported a close association between the alteration of specific sperm DNA methylation signatures and semen quality.
OBJECTIVES
To evaluate the effect of tree nut consumption on sperm DNA methylation patterns in healthy individuals reporting eating a Western-style diet.
MATERIAL AND METHODS
This is a post hoc analysis conducted in a subset of participants (healthy, non-smoking, and young) from the FERTINUTS 14-wk randomized-controlled, parallel trial, recruited between December 2015 and February 2017. The participants included in the current study (n = 72) were randomly selected in a proportion 2:1 from the original FERTINUTS trial between the 98 participants that completed the entire dietary intervention (nut group, n = 48; control group, n = 24). Sperm DNA methylation patterns were examined at baseline and after 14 weeks in 48 individuals consuming 60 g/d of mixed nuts (nut group) and in 24 individuals following the usual Western-style diet avoiding consumption of nuts (control group).
RESULTS
Over the course of the trial, no significant changes in global methylation were observed between groups. However, in the nut group, we identified 36 genomic regions that were significantly differentially methylated between the baseline and the end of the trial and 97.2% of the regions displayed hypermethylation. We identified no such change in the control group over the same period of time. We also utilized the recently developed germ line age calculator to determine if nut consumption resulted in alterations to the epigenetic age of cells and no significant differences were found.
DISCUSSION AND CONCLUSION
Adding nuts to a regular Western-style diet subtly impacts sperm DNA methylation in specific regions, demonstrating that there are some sperm epigenome regions that could respond to diet.",2020,", no significant changes in global methylation were observed between groups.","['participants included in the current study (n=72) were randomly selected in a proportion 2:1 from the original FERTINUTS trial between the 98 participants that completed the entire dietary intervention (nut group, n=48; control group, n=24', 'healthy individuals reporting eating a Western-style diet', 'healthy males consuming a Western-style diet', 'participants (healthy, non-smoking, and young) from the FERTINUTS 14-wk randomized-controlled, parallel-trial, recruited between December 2015 and February 2017']","['tree nuts consumption', 'usual Western-style diet avoiding consumption of nuts (control group']",['global methylation'],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C3714627', 'cui_str': 'Tree nut'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}]",72.0,0.0423172,", no significant changes in global methylation were observed between groups.","[{'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Salas-Huetos', 'Affiliation': 'Human Nutrition Unit, Biochemistry and Biotechnology Department, Faculty of Medicine and Health Sciences, Universitat Rovira i Virgili (URV), Reus, Spain.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'James', 'Affiliation': 'Andrology and IVF Laboratory, Division of Urology, Department of Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'Human Nutrition Unit, Biochemistry and Biotechnology Department, Faculty of Medicine and Health Sciences, Universitat Rovira i Virgili (URV), Reus, Spain.'}, {'ForeName': 'Mònica', 'Initials': 'M', 'LastName': 'Bulló', 'Affiliation': 'Human Nutrition Unit, Biochemistry and Biotechnology Department, Faculty of Medicine and Health Sciences, Universitat Rovira i Virgili (URV), Reus, Spain.'}, {'ForeName': 'Kenneth I', 'Initials': 'KI', 'LastName': 'Aston', 'Affiliation': 'Andrology and IVF Laboratory, Division of Urology, Department of Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Douglas T', 'Initials': 'DT', 'LastName': 'Carrell', 'Affiliation': 'Andrology and IVF Laboratory, Division of Urology, Department of Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Jenkins', 'Affiliation': 'Andrology and IVF Laboratory, Division of Urology, Department of Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA.'}]",Andrology,['10.1111/andr.12911']
2819,32966703,"Food Structure Modulates the Bioavailability of Triglycerides and Vitamin D, and Partly That of Lutein: A Randomized Trial with a Crossover Design in Adults.","SCOPE
The specific effect of the food matrix structure on fat-soluble micronutrient bioavailability is only partly understood. Evaluating fat-soluble micronutrient bioavailability after consumption of foods displaying similar composition but different structure is aimed at.
METHODS AND RESULTS
Twelve healthy subjects are enrolled in a randomized, open label, crossover postprandial trial. Four different model foods are tested: custard, pudding, sponge cake, and biscuit. Vitamin D 3 , lutein, and triglyceride chylomicron responses, evaluated as postprandial areas under the curve, are then assayed. Custard triglyceride response is higher than pudding and biscuit responses (up to +122.7%, p < 0.0001). Sponge cake vitamin D 3 response is higher than biscuit response (+26.6%, p = 0.047). No difference between the model foods are observed regarding lutein responses. Triglyceride responses peak at 3 h for all conditions, while vitamin D 3 and lutein peaks are delayed by 1 h with the biscuit matrix compared to other model foods.
CONCLUSION
Food structure can significantly impact on triglyceride and vitamin D 3 bioavailability in terms of absorbed amounts and/or maximum absorption time. The data highlight positive correlations between triglyceride, vitamin D, and lutein nutrient responses. These results are of particular interest to develop functional foods for population subgroups such as the elderly.",2020,"Sponge cake vitamin D 3 response was higher than biscuit response (+26.6%, p = 0.047).","['humans after consumption of foods displaying similar composition but different structure', 'Adults', 'Twelve healthy subjects']","['Sponge cake vitamin D', 'Lutein']","['Custard triglyceride response', 'biscuit response', 'Vitamin D 3 , lutein and triglyceride chylomicron responses', 'triglyceride, vitamin D and lutein responses', 'Bioavailability of Triglycerides and Vitamin D', 'TG responses', 'lutein responses']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0452620', 'cui_str': 'Sponge cake'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}]","[{'cui': 'C0453512', 'cui_str': 'Custard'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0008731', 'cui_str': 'Chylomicrons'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",12.0,0.0333842,"Sponge cake vitamin D 3 response was higher than biscuit response (+26.6%, p = 0.047).","[{'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Gleize', 'Affiliation': 'INRAE, Avignon Université, UMR SQPOV, Avignon, 84914, France.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Hiolle', 'Affiliation': 'STLO, INRAE, AGROCAMPUS OUEST, Rennes, 35042, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Meunier', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Recherche en Nutrition Humaine Auvergne, Clermont-Ferrand, 63000, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'CHU Clermont-Ferrand, DRCI, Clermont-Ferrand, 63000, France.'}, {'ForeName': 'Ruddy', 'Initials': 'R', 'LastName': 'Richard', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Recherche en Nutrition Humaine Auvergne, Clermont-Ferrand, 63000, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Savary-Auzeloux', 'Affiliation': 'INRAE, Unité de Nutrition Humaine, UMR1019, University Clermont Auvergne, Clermont-Ferrand, F-63000, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Buffière', 'Affiliation': 'INRAE, Unité de Nutrition Humaine, UMR1019, University Clermont Auvergne, Clermont-Ferrand, F-63000, France.'}, {'ForeName': 'Marie-Agnès', 'Initials': 'MA', 'LastName': 'Peyron', 'Affiliation': 'INRAE, Unité de Nutrition Humaine, UMR1019, University Clermont Auvergne, Clermont-Ferrand, F-63000, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Halimi', 'Affiliation': 'Aix-Marseille Université, INRAE, INSERM, C2VN, Marseille, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Caris-Veyrat', 'Affiliation': 'INRAE, Avignon Université, UMR SQPOV, Avignon, 84914, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Nau', 'Affiliation': 'STLO, INRAE, AGROCAMPUS OUEST, Rennes, 35042, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Reboul', 'Affiliation': 'Aix-Marseille Université, INRAE, INSERM, C2VN, Marseille, France.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000228']
2820,32967726,Electrolytes supplementation can decrease the risk of nephrotoxicity in patients with solid tumors undergoing chemotherapy with cisplatin.,"BACKGROUND
Cisplatin is an important drug in the treatment of various Cancers. However, this drug causes nephrotoxicity that is linked to electrolyte derangement. The aim of this study was to evaluate the effect of electrolyte supplementation in reducing kidney injury in patients receiving cisplatin-based regimen.
METHODS
This was non-randomized interventional study conducted at Ocean Road Cancer Institute (ORCI) among patients with confirmed solid tumors. Patients who received cisplatin-based chemotherapy at a dose of ≥50 mg with intravenous normal saline supplemented with Magnesium, Calcium and Potassium (triple electrolyte supplementation) were compared with those who received cisplatin-based chemotherapy with normal saline alone. The patients were followed up for 4 weeks and serum creatinine was measured at every visit. Nephrotoxicity was defined as serum creatinine elevation > 1.5 times that at baseline.
RESULTS
A total of 99 patients were recruited, whereby 49 patients (49.5%) received electrolyte supplementation (treatment group) and 50 patients (51.5%) did not receive electrolyte supplementation (control group). The incidence risk of nephrotoxicity was 20.41% (n = 10) in the treatment group and 54% (n = 27) in the control group. Patients in the control group were 2.6 times more likely to experience nephrotoxicity as compared to treatment group [Relative Risks (RR); 2.6, 95%CI; 1.5-4.9, P < 0.0001]. The most common malignancy was cervical cancer, n = 43 (87.8%) in treatment group and n = 45 (90.0%) in the control group (P = 0.590). The Kaplan-Meier analysis and the log-rank test revealed that electrolytes supplementation was associated with extended survival with less nephrotoxicity incidences [P = 0.0004; Hazard ratio (HR) 0.3149; 95% CI 0.165 to 0.6011].
CONCLUSIONS
Electrolytes supplementation decreases the risk of nephrotoxicity after chemotherapy with cisplatin. A randomized controlled trial with a larger sample size is recommended to evaluate the robustness of these findings.",2020,The incidence risk of nephrotoxicity was 20.41% (n = 10) in the treatment group and 54% (n = 27) in the control group.,"['patients with solid tumors undergoing chemotherapy with', 'A total of 99 patients were recruited, whereby 49 patients (49.5%) received', 'patients with confirmed solid tumors', 'patients receiving cisplatin-based regimen']","['electrolyte supplementation', 'cisplatin-based chemotherapy', 'cisplatin', 'Electrolytes supplementation', 'intravenous normal saline supplemented with Magnesium, Calcium and Potassium (triple electrolyte supplementation', 'Cisplatin', 'cisplatin-based chemotherapy with normal saline alone', 'electrolyte supplementation (control group']","['experience nephrotoxicity', 'serum creatinine', 'incidence risk of nephrotoxicity', 'serum creatinine elevation', 'risk of nephrotoxicity', 'Nephrotoxicity', 'extended survival with less nephrotoxicity incidences']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",99.0,0.200158,The incidence risk of nephrotoxicity was 20.41% (n = 10) in the treatment group and 54% (n = 27) in the control group.,"[{'ForeName': 'Omary M S', 'Initials': 'OMS', 'LastName': 'Minzi', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania. minziobejayesu@gmail.com.'}, {'ForeName': 'Tatu E', 'Initials': 'TE', 'LastName': 'Lyimo', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.'}, {'ForeName': 'Francis F', 'Initials': 'FF', 'LastName': 'Furia', 'Affiliation': 'Department of Paediatrics and Child Health, School of Medicine, Muhimbili University of Health and Allied Sciences, P. O. Box 65001, Dar es Salaam, Tanzania.'}, {'ForeName': 'Alphonce I', 'Initials': 'AI', 'LastName': 'Marealle', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.'}, {'ForeName': 'Manase', 'Initials': 'M', 'LastName': 'Kilonzi', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.'}, {'ForeName': 'George M', 'Initials': 'GM', 'LastName': 'Bwire', 'Affiliation': 'Department of Pharmaceutical Microbiology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Malichewe', 'Affiliation': 'Department of Radiology, MUHAS, P.O. Box 65000, Dar es Salaam, Tanzania.'}]",BMC pharmacology & toxicology,['10.1186/s40360-020-00448-9']
2821,32967742,"Casein glycomacropeptide is well tolerated in healthy adults and changes neither high-sensitive C-reactive protein, gut microbiota nor faecal butyrate: a restricted randomised trial.","Casein glycomacropeptide (CGMP) is a bioactive milk-derived peptide with potential anti-inflammatory effects. Animal studies suggest that CGMP may work by altering gut microbiota composition and enhancing butyrate production. Its effects on intestinal homoeostasis, microbiota and metabolites in humans are unknown. The aim of the present study was to assess both the intestinal and systemic immunomodulatory effects of orally ingested CGMP. We hypothesised that daily oral CGMP intake would reduce high-sensitive C-reactive protein (hsCRP) in healthy adults. In a single-centre limited but randomised, double-blinded, reference-controlled study, we compared the effects of a 4-week intervention of either 25 g of oral powder-based chocolate-flavoured CGMP or a reference drink. We included twenty-four healthy adults who all completed the study. CGMP had no systemic or intestinal immunomodulatory effects compared with a reference drink, with regard to either hsCRP or faecal calprotectin level, faecal microbiota composition or faecal SCFA content. CGMP ingestion did not affect satiety or body weight, and it caused no severe adverse events. The palatability of CGMP was acceptable, and adherence was high. CGMP did not induce or change gastrointestinal symptoms. In conclusion, we found no immunomodulatory effects of CGMP in healthy adults. In a minor group of healthy adults, oral ingestion of 25 g of CGMP during 4 weeks was safe, well tolerated, had acceptable palatability and was without any effects on body weight.",2020,"CGMP had no systemic or intestinal immunomodulatory effects compared with a reference drink, either with regard to high-sensitive C-reactive protein, or faecal calprotectin level, faecal microbiota composition or faecal short-chain fatty acid content.","['twenty-four healthy adults who all completed the study', 'healthy adults']","['Casein glycomacropeptide (CGMP', 'orally ingested CGMP', 'oral powder-based chocolate-flavoured CGMP or a reference drink', 'CGMP', 'Casein glycomacropeptide']","['safe, well tolerated, had acceptable palatability', 'systemic or intestinal immunomodulatory effects', 'faecal calprotectin level, faecal microbiota composition or faecal short-chain fatty acid content', 'intestinal homeostasis, microbiota and metabolites', 'gut microbiota composition and enhancing butyrate production', 'satiety or body weight', 'body weight', 'change gastrointestinal symptoms', 'palatability of CGMP']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0286762', 'cui_str': 'caseinomacropeptide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1160731', 'cui_str': 'Oral powder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0286762', 'cui_str': 'caseinomacropeptide'}]",24.0,0.195539,"CGMP had no systemic or intestinal immunomodulatory effects compared with a reference drink, either with regard to high-sensitive C-reactive protein, or faecal calprotectin level, faecal microbiota composition or faecal short-chain fatty acid content.","[{'ForeName': 'Pernille G', 'Initials': 'PG', 'LastName': 'Wernlund', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, 8200Aarhus, Denmark.'}, {'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Hvas', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, 8200Aarhus, Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Dahlerup', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, 8200Aarhus, Denmark.'}, {'ForeName': 'Martin I', 'Initials': 'MI', 'LastName': 'Bahl', 'Affiliation': 'Research Group for Gut, Microbes and Health, National Food Institute, Technical University of Denmark, 2800Kgs. Lyngby, Denmark.'}, {'ForeName': 'Tine R', 'Initials': 'TR', 'LastName': 'Licht', 'Affiliation': 'Research Group for Gut, Microbes and Health, National Food Institute, Technical University of Denmark, 2800Kgs. Lyngby, Denmark.'}, {'ForeName': 'Knud E B', 'Initials': 'KEB', 'LastName': 'Knudsen', 'Affiliation': 'Department of Animal Science, Aarhus University, 8830Tjele, Denmark.'}, {'ForeName': 'Jørgen S', 'Initials': 'JS', 'LastName': 'Agnholt', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, 8200Aarhus, Denmark.'}]",The British journal of nutrition,['10.1017/S0007114520003736']
2822,32928570,Cognitive Behavioral Therapy With Stabilization Exercises Affects Transverse Abdominis Muscle Thickness in Patients With Chronic Low Back Pain: A Double-Blinded Randomized Trial Study.,"OBJECTIVE
Nonspecific chronic low back pain (NCLBP) is a major public health and global socioeconomic burden with a variety of symptoms, such as fear-avoidance behaviors. This study aimed to evaluate the effect of cognitive behavioral therapy (CBT) associated with stabilization exercise (SE) on thickness of transverse abdominis (TrA) muscle in patients with NCLBP.
METHODS
Forty patients with NCLBP were randomly assigned into experimental CBT associated with SE (n = 20) and control groups without SE (n = 20). Transverse abdominis muscle thickness was assessed during abdominal drawing in maneuver (ADIM) and active straight leg raise (ASLR) of the right lower limb using ultrasound imaging. Fear-avoidance belief and disability were evaluated using a fear-avoidance belief questionnaire (FABQ) and a Roland-Morris disability questionnaire (RMDQ) before and after intervention.
RESULTS
Mixed-model analysis of variance indicated that the effect of time was significant for the right and left TrA contraction thickness during ADIM and left TrA contraction thickness during ASLR (P < .05). However, the experimental group exhibited higher right and left TrA muscle thickness compared with the control group during ADIM (P = .001). Moreover, there were no significant differences between groups in the thickness of TrA muscle during ASLR (P > .05). The effect of time was significant for FABQ (P = .02) and RMDQ (P = .01); however, the effect of group was significant for the FABQ after intervention (P = .04).
CONCLUSIONS
Stabilization exercise associated with CBT is more effective than SE alone in improving fear avoidance belief and in increasing the thickness of the TrA muscle during ADIM task.",2020,"The effect of time was significant for FABQ (P = .02) and RMDQ (P = .01); however, the effect of group was significant for the FABQ after intervention (P = .04).
","['Patients With Chronic Low Back Pain', 'Forty patients with NCLBP', 'patients with NCLBP', 'Nonspecific chronic low back pain (NCLBP']","['CBT associated with SE (n\u202f=\u202f20) and control groups without SE', 'stabilization exercise (SE', 'cognitive behavioral therapy (CBT', 'Cognitive Behavioral Therapy With Stabilization Exercises']","['Transverse Abdominis Muscle Thickness', 'right and left TrA contraction thickness during ADIM and left TrA contraction thickness', 'FABQ', 'higher right and left TrA muscle thickness', 'Fear-avoidance belief and disability', 'thickness of TrA muscle during ASLR', 'Transverse abdominis muscle thickness', 'fear-avoidance belief questionnaire (FABQ) and a Roland-Morris disability questionnaire (RMDQ', 'thickness of transverse abdominis (TrA) muscle', 'RMDQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}]",40.0,0.045285,"The effect of time was significant for FABQ (P = .02) and RMDQ (P = .01); however, the effect of group was significant for the FABQ after intervention (P = .04).
","[{'ForeName': 'Rasool', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Rozita', 'Initials': 'R', 'LastName': 'Hedayati', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: Hedayati@semums.ac.ir.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ehsani', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Hemati-Boruojeni', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Afsane', 'Initials': 'A', 'LastName': 'Abri', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Taghizadeh Delkhosh', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.03.015']
2823,32928957,Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies.,"OBJECTIVE
To evaluate the incidence and risk factors for diabetic ketoacidosis (DKA) and related adverse events (AEs) in adults with type 1 diabetes treated with sotagliflozin adjunctive to insulin.
RESEARCH DESIGN AND METHODS
Data from two identically designed, 52-week, randomized studies were pooled and analyzed for DKA, changes in β-hydroxybutyrate (BHB), and percentage of patients with BHB >0.6 and >1.5 mmol/L. The patients were administered placebo, sotagliflozin 200 mg, or sotagliflozin 400 mg once daily.
RESULTS
A total of 191 ketosis-related AEs were reported, and 98 underwent adjudication. Of these, 37 events (36 patients) were adjudicated as DKA, with an exposure-adjusted incidence rate of 0.2, 3.1, and 4.2 events per 100 patient-years for placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg, respectively. No patient died of a DKA event. From a baseline BHB of ∼0.13 mmol/L, sotagliflozin treatment led to a small median increase over 52 weeks (≤0.05 mmol/L at all time points). Of sotagliflozin-treated patients, approximately 47% and 7% had ≥1 BHB measurement >0.6 mmol/L and >1.5 mmol/L, respectively (vs. 20% and 2%, respectively, of placebo-treated patients). Subsequent to the implementation of a risk mitigation plan, annualized DKA incidence was lower versus preimplementation in both the sotagliflozin 200 and 400 mg groups.
CONCLUSIONS
In patients with type 1 diabetes, confirmed DKA incidence increased when sotagliflozin was added to insulin compared with insulin alone. A lower incidence of DKA was observed following the implementation of an enhanced risk mitigation plan, suggesting that this risk can be managed with patient education.",2020,"Subsequent to the implementation of a risk mitigation plan, annualized DKA incidence was lower versus preimplementation in both the sotagliflozin 200 and 400 mg groups.
","['Adults With Type 1 Diabetes', 'adults with type 1 diabetes treated with sotagliflozin adjunctive to insulin', 'Data from two identically designed, 52-week, randomized studies were pooled and analyzed for DKA, changes in β-hydroxybutyrate (BHB), and percentage of patients with BHB >0.6 and >1.5 mmol/L', '37 events (36 patients) were adjudicated as DKA, with an exposure-adjusted incidence rate of 0.2, 3.1, and 4.2 events per 100 patient-years for']","['placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg', 'placebo, sotagliflozin 200 mg, or sotagliflozin 400 mg once daily', 'Sotagliflozin', 'sotagliflozin']","['DKA incidence', 'Diabetic Ketoacidosis', 'annualized DKA incidence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.15226,"Subsequent to the implementation of a risk mitigation plan, annualized DKA incidence was lower versus preimplementation in both the sotagliflozin 200 and 400 mg groups.
","[{'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Peters', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, CA annepete@med.usc.edu.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center at Dallas, Dallas, TX.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Kinder Krakenhaus auf der Bult, Diabetes Zentrum für Kinder and Jugendliche, Hannover, Germany.'}, {'ForeName': 'Jake A', 'Initials': 'JA', 'LastName': 'Kushner', 'Affiliation': 'McNair Interests, Houston, TX.'}, {'ForeName': 'Helena W', 'Initials': 'HW', 'LastName': 'Rodbard', 'Affiliation': 'Endocrine and Metabolic Consultants Research Center, Rockville, MD.'}, {'ForeName': 'Ketan', 'Initials': 'K', 'LastName': 'Dhatariya', 'Affiliation': 'Norfolk and Norwich University Hospitals National Health Service Foundation Trust, Norwich, U.K.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Sawhney', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Banks', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Lapuerta', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}]",Diabetes care,['10.2337/dc20-0924']
2824,32928216,Zinc supplementation affects favorably the frequency of migraine attacks: a double-blind randomized placebo-controlled clinical trial.,"BACKGROUND
Observational studies have shown a link between zinc deficiency and migraine headaches. We aimed to examine the effect of zinc supplementation on the characteristics of migraine attacks in patients with migraine.
METHODS
This randomized clinical trial was conducted on 80 patients with migraine. Patients were randomly assigned to receive either zinc sulfate (220 mg/d zinc sulfate) or placebo (lactose) for 8 weeks. Anthropometric measures, serum zinc concentrations, and characteristics of migraine attacks (headache severity, frequency and duration of migraine attacks, and headache daily results) were assessed at baseline and end of the trial.
RESULTS
Compared with the placebo, zinc supplementation resulted in a significant reduction in headache severity (- 1.75 ± 1.79 vs. -0.80 ± 1.57; P = 0.01) and migraine attacks frequency (- 2.55 ± 4.32 vs. -0.42 ± 4.24; P = 0.02) in migraine patients. However, the observed reduction for headache severity became statistically non-significant when the analysis was adjusted for potential confounders and baseline values of headache severity. Other characteristics of migraine attacks including the duration of attacks and headache daily results were not altered following zinc supplementation either before or after controlling for covariates.
CONCLUSION
Zinc supplementation had a beneficial effect on the frequency of migraine attacks in migraine patients. Additional well-designed clinical trials with a long period of intervention and different dosages of zinc are required.
TRIAL REGISTRATION CODE
IRCT20121216011763N23 at www.irct.ir .",2020,"Compared with the placebo, zinc supplementation resulted in a significant reduction in headache severity (- 1.75 ± 1.79 vs. -0.80 ± 1.57; P = 0.01) and migraine attacks frequency (- 2.55 ± 4.32 vs. -0.42 ± 4.24; P = 0.02) in migraine patients.","['80 patients with migraine', 'patients with migraine', 'migraine patients']","['Zinc supplementation', 'placebo', 'zinc supplementation', 'zinc sulfate (220\u2009mg/d zinc sulfate) or placebo (lactose', 'placebo, zinc supplementation']","['duration of attacks and headache daily results', 'frequency of migraine attacks', 'headache severity', 'Anthropometric measures, serum zinc concentrations, and characteristics of migraine attacks (headache severity, frequency and duration of migraine attacks, and headache daily results', 'migraine attacks frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0856205', 'cui_str': 'Serum zinc'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",80.0,0.450099,"Compared with the placebo, zinc supplementation resulted in a significant reduction in headache severity (- 1.75 ± 1.79 vs. -0.80 ± 1.57; P = 0.01) and migraine attacks frequency (- 2.55 ± 4.32 vs. -0.42 ± 4.24; P = 0.02) in migraine patients.","[{'ForeName': 'Hedieh', 'Initials': 'H', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, P.O. Box 8174673461, Isfahan, Iran.'}, {'ForeName': 'Seyedeh Shabnam', 'Initials': 'SS', 'LastName': 'Mazloumi-Kiapey', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Sadeghi', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Khorvash', 'Affiliation': 'Neurology Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Tayebeh', 'Initials': 'T', 'LastName': 'Mottaghi', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, P.O. Box 8174673461, Isfahan, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Askari', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, P.O. Box 8174673461, Isfahan, Iran. askari@mui.ac.ir.'}]",Nutrition journal,['10.1186/s12937-020-00618-9']
2825,32933950,"Comparison of weight-based insulin titration (WIT) and glucose-based insulin titration using basal-bolus algorithm in hospitalized patients with type 2 diabetes: a multicenter, randomized, clinical study.","INTRODUCTION
Subcutaneous administration of insulin is the preferred method for achieving glucose control in non-critically ill patients with diabetes. Glucose-based titration protocols were widely applied in clinical practice. However, most of these algorithms are experience-based and there is considerable variability and complexity. This study aimed to compare the effectiveness and safety of a weight-based insulin titration algorithm versus glucose-based algorithm in hospitalized patients with type 2 diabetes mellitus (T2DM).
RESEARCH DESIGN AND METHODS
This randomized clinical trial was carried out at four centers in the South, Central and North China. Inpatients with T2DM were randomly assigned (1:1) to receive weight-based and glucose-based insulin titration algorithms. The primary outcome was the length of time for reaching blood glucose (BG) targets (fasting BG (FBG) and 2-hour postprandial BG (2hBG) after three meals). The secondary outcome included insulin dose for achieving glycemic control and the incidence of hypoglycemia during hospitalization.
RESULTS
Between January 2016 and June 2019, 780 patients were screened, and 575 completed the trial (283 in the weight-based group and 292 in the glucose-based group). The lengths of time for reaching BG targets at four time points were comparable between two groups. FBG reached targets within 3 days and 2hBG after three meals within 4 days. There is no significant difference in insulin doses between two groups at the end of the study. The total daily dosage was about 1 unit/kg/day, and the ratio of basal-to-bolus was about 2:3 in both groups. The incidence of hypoglycemia was similar in both groups, and severe hypoglycemia was not detected in either of the groups.
CONCLUSIONS
Weight-based insulin titration algorithm is equally effective and safe in hospitalized patients with T2DM compared with glucose-based algorithm.
TRIAL REGISTRATION NUMBER
NCT03220919.",2020,"The incidence of hypoglycemia was similar in both groups, and severe hypoglycemia was not detected in either of the groups.
","['non-critically ill patients with diabetes', 'Inpatients with T2DM', 'hospitalized patients with type 2 diabetes mellitus (T2DM', 'hospitalized patients with type 2 diabetes', 'hospitalized patients with T2DM', 'four centers in the South, Central and North China', 'Between January 2016 and June 2019, 780 patients were screened, and 575 completed the trial (283 in the weight-based group and 292 in the glucose-based group']","['Weight-based insulin titration algorithm', 'weight-based insulin titration algorithm versus glucose-based algorithm', 'weight-based insulin titration (WIT) and glucose-based insulin titration using basal-bolus algorithm', 'weight-based and glucose-based insulin titration algorithms']","['lengths of time for reaching BG targets', 'effectiveness and safety', 'severe hypoglycemia', 'length of time for reaching blood glucose (BG) targets (fasting BG (FBG) and 2-hour postprandial BG (2hBG', 'total daily dosage', 'incidence of hypoglycemia', 'insulin dose for achieving glycemic control and the incidence of hypoglycemia during hospitalization']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3844102', 'cui_str': '575'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205112', 'cui_str': 'Basal'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",780.0,0.056287,"The incidence of hypoglycemia was similar in both groups, and severe hypoglycemia was not detected in either of the groups.
","[{'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, The Third Affiliated Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Guangda', 'Initials': 'G', 'LastName': 'Xiang', 'Affiliation': ""Department of Endocrinology, Wuhan General Hospital of Chinese People's Liberation Army, Wuhan, China.""}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Du', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yunjuan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Singla Sethiel', 'Initials': 'SS', 'LastName': 'Mosha', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Wangen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China liwg660@126.com.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001261']
2826,32935921,Cutaneous adverse events in a randomized controlled trial of flash glucose monitoring among youth with type 1 diabetes mellitus.,"BACKGROUND
The literature regarding flash glucose monitoring (FGM)-associated cutaneous adverse events (AE) is limited.
OBJECTIVES
This study among youth participating in a 6 month randomized controlled trial aimed to compare cutaneous AE between FGM and self-monitored blood glucose (SMBG) use and evaluate premature FGM sensor loss.
METHODS
Patients aged 13 to 20 years with type 1 diabetes were randomized to intervention (FGM and usual care) or control (SMBG and usual care). Participants self-reported cutaneous AEs electronically every 14 days. Reports were analyzed to determine frequency, type, and severity of cutaneous AEs, and evaluate premature sensor loss.
RESULTS
Sixty-four participants were recruited; 33 randomized to FGM and 31 to control. In total, 80 cutaneous AEs were reported (40 in each group); however, the proportion of participants experiencing cutaneous AEs was greater in the FGM group compared to control (58% and 23% respectively, P = .004). FGM participants most frequently reported erythema (50% of AEs), while controls most commonly reported skin hardening (60% of AEs). For FGM users, 80.0% of cutaneous AEs were mild, 17.5% moderate, and 2.5% severe. Among controls, 82.5% of cutaneous AEs were mild and 17.5% moderate. One participant ceased using FGM due to recurring cutaneous AEs. Additionally, over 6 months, 82% of FGM participants experienced at least one premature sensor loss, largely unrelated to a cutaneous AE.
CONCLUSIONS
Cutaneous FGM-associated AEs are common, and mostly rated as mild. However, the majority of users continued FGM despite cutaneous AEs. Awareness of cutaneous complications and mitigation measures may reduce cutaneous AEs and improve the overall experience of FGM.",2020,"FGM participants most frequently reported erythema (50% of AEs), while controls most commonly reported skin hardening (60% of AEs).","['Patients aged 13-20\u2009years with type 1 diabetes', 'Youth with Type 1 Diabetes Mellitus', 'youth participating in a six-month randomized controlled trial (RCT', 'Sixty-four participants were recruited; 33 randomized to']","['Flash Glucose Monitoring', 'intervention (FGM and usual care) or control (SMBG and usual care', 'FGM']","['proportion of participants experiencing cutaneous AEs', 'skin hardening', 'erythema', 'cutaneous adverse events (AE) between FGM and self-monitored blood glucose (SMBG) use and evaluate premature FGM sensor loss', 'premature sensor loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]",64.0,0.0741514,"FGM participants most frequently reported erythema (50% of AEs), while controls most commonly reported skin hardening (60% of AEs).","[{'ForeName': 'Brooke L', 'Initials': 'BL', 'LastName': 'Marsters', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Boucher', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Galland', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Esko J', 'Initials': 'EJ', 'LastName': 'Wiltshire', 'Affiliation': 'Department of Paediatrics and Child Health, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Martin I', 'Initials': 'MI', 'LastName': 'de Bock', 'Affiliation': 'Department of Paediatrics, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tomlinson', 'Affiliation': 'Paediatric Department, Southern District Health Board, Invercargill, New Zealand.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Rayns', 'Affiliation': 'Endocrinology Department, Southern District Health Board, Dunedin, New Zealand.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'MacKenzie', 'Affiliation': 'Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chan', 'Affiliation': 'Department of Endocrinology and General Medicine, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Wheeler', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}]",Pediatric diabetes,['10.1111/pedi.13121']
2827,32937273,"Short-term and long-term effects of ankle joint taping and bandaging on balance, proprioception and vertical jump among volleyball players with chronic ankle instability.","OBJECTIVE
This study hypothesized that the prolonged use of taping during athletic activities produces more significant increases in proprioception, balance, and vertical jump among volleyball players with CAI.
DESIGN
A randomized controlled study.
PARTICIPANTS
One-hundred participants with chronic ankle instability (CAI) participated in this study. Participants were distributed into 3-groups: taping group, bandaging group, and control group.
PRIMARY OUTCOME MEASURES
Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester).
INTERVENTIONS
Three interventions were performed: ankle rigid taping, ankle bandaging, and placebo taping. The measurements were performed at baseline, immediately, 2-weeks and 2-months after support.
RESULTS
Immediately after supports, there were non-significant differences between all groups for proprioception, balance (P < .05). There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P < .05). After 2-weeks and 2-months, there were significant differences between bandaging and control groups, and taping and control groups for proprioception, balance, and vertical jump (P < .05). There were non-significant differences between taping and bandaging groups (P < .05) during all assessments.
CONCLUSION
This study indicated that ankle taping and bandaging immediately improve vertical jump only; while they improve proprioception, balance, and vertical jump after 2-weeks and 2-months.",2020,"There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P ","['One-hundred participants with chronic ankle instability (CAI) participated in this study', 'volleyball players with CAI', 'volleyball players with chronic ankle instability']","['ankle joint taping and bandaging', 'taping group, bandaging group, and control group', 'ankle rigid taping, ankle bandaging, and placebo taping']","['proprioception, balance, and vertical jump', 'proprioception, balance, and vertical jump (P', 'Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester', 'proprioception, balance', 'balance, proprioception and vertical jump']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}]","[{'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0183885', 'cui_str': 'Tester'}]",100.0,0.0294532,"There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P ","[{'ForeName': 'Motaz', 'Initials': 'M', 'LastName': 'Alawna', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey; Department of Physiotherapy and Rehabilitation, Faculty of Allied Medical Sciences, Arab American University, Jenin, Palestine. Electronic address: malawna@gelisim.edu.tr.'}, {'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.015']
2828,32939904,Hypochlorous acid water prevents postoperative intrauterine infection after microwave endometrial ablation.,"AIM
We investigated the effects of uterine cavity lavage using hypochlorous acid water (HClO) on preventing postoperative intrauterine infection after microwave endometrial ablation (MEA).
METHODS
Four hundred and eleven consecutive patients were enrolled in this study. The patients were divided into two groups: 214 cases in 2014-2016 with disinfection using povidone-iodine antiseptic solution alone (group A) and 197 cases in 2017-2019 with additional intrauterine douche using HClO (group B). HClO was used at a concentration of 200 ppm of residual chlorine. One gram of Ceftriaxone Sodium Hydrate was administered by drip infusion during MEA in both groups. Oral antibiotics were administered after MEA only in group A but not in group B.
RESULTS
Mean patient age (mean ± SD; years old) was 44.5 ± 4.6 in group A and 44.8 ± 5.4 in group B, and mean operation time (min) was 30.4 ± 19.1 in group A and 34.4 ± 22.6 in group B, respectively. Neither were significantly different between groups. The combined ablation techniques i.e. transcervical microwave myolysis and transcervical microwave adenomyolysis did not increase frequency of infection. Postoperative intrauterine infection cases in group B (8 cases) were significantly lower than those in group A (28 cases) (Chi-square test, P = 0.001). Hysterectomy was performed in three severe intrauterine infection cases in group A, but no cases of severe intrauterine infection was found in group B. No adverse effect of HClO was seen.
CONCLUSION
Intrauterine douche using HClO decreases postoperative intrauterine infection after MEA.",2020,Postoperative intrauterine infection cases in group B (8 cases) were significantly lower than those in group A (28 cases),"['patients were divided into two groups: 214 cases in 2014-2016 with', 'after microwave endometrial ablation (MEA', 'Group A) and 197 cases in 2017-2019 with additional intrauterine douche using HClO (Group B', 'Four hundred and eleven consecutive patients were enrolled in this study']","['HClO', 'Oral antibiotics', 'Hypochlorous acid water', 'uterine cavity lavage using hypochlorous acid water (HClO', 'Ceftriaxone Sodium Hydrate', 'disinfection using povidone-iodine antiseptic solution alone']","['Postoperative intrauterine infection cases', 'postoperative intrauterine infection', 'mean operation time', 'adverse effect of HClO', 'severe intrauterine infection', 'frequency of infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0026051', 'cui_str': 'Microwave'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0150554', 'cui_str': 'Douche'}, {'cui': 'C0020600', 'cui_str': 'Hypochlorous acid'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020600', 'cui_str': 'Hypochlorous acid'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0227844', 'cui_str': 'Endometrial cavity structure'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0700527', 'cui_str': 'Ceftriaxone sodium'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1112157', 'cui_str': 'Intrauterine infection'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0020600', 'cui_str': 'Hypochlorous acid'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",411.0,0.0224565,Postoperative intrauterine infection cases in group B (8 cases) were significantly lower than those in group A (28 cases),"[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tsuda', 'Affiliation': 'Sanno Ladies Clinic, Akita, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Kanaoka', 'Affiliation': 'Department of Gynecology, Iseikai Hospital, Osaka, Japan.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14471']
2829,32943290,In-Person Contacts and Their Relationship With Alcohol Consumption Among Young Adults With Hazardous Drinking During a Pandemic.,"PURPOSE
Social distancing strategies such as ""stay-at-home"" (SAH) orders can slow the transmission of contagious viruses like the SARS-CoV-2 virus, but require population adherence to be effective. This study explored adherence to SAH orders by young adults with hazardous drinking, and the role of alcohol consumption with in-person contacts on adherence.
METHODS
Analyses included young adults with hazardous drinking (i.e., AUDIT-C score ≥3/4 for women/men; n = 50; ages 18-25) participating in a randomized trial in Pittsburgh, PA. Participants provided experience sampling reports on drinking twice per week from the week before SAH orders started on April 1, 2020 through 6 weeks during the SAH period. We examined how in-person contact with non-household friends changed over time and event-level relationships between alcohol consumption and in-person contacts.
RESULTS
The percentage of participants with any in-person contact in the week before SAH was 44% (95% confidence interval [CI] 30%-59%), which decreased to 29% (95% CI 15%-43%) in the first SAH week and increased to 65% (95% CI 46%-85%) by SAH week 6. Controlling for average levels of alcohol consumption, on days when young adults drank, participants reported more in-person contacts compared to nondrinking days.
CONCLUSIONS
Preliminary data indicate that, among young adults with hazardous drinking, adherence to public policies like SAH orders is suboptimal, declines over time, and is associated with drinking events. Interventions aimed at enhancing young adults' adherence to social distancing policies are urgently needed.",2020,"Controlling for average levels of alcohol consumption, on days when young adults drank, participants reported more in-person contacts compared to nondrinking days.
","['young adults with hazardous drinking, and the role of alcohol consumption with in-person contacts on adherence', 'Analyses included young adults with hazardous drinking (i.e., AUDIT-C score ≥3/4 for women/men; n\xa0= 50; ages 18-25) participating in a randomized trial in Pittsburgh, PA', 'Young Adults With Hazardous Drinking During a Pandemic', 'young adults with hazardous drinking']",[],[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]",[],[],,0.0502342,"Controlling for average levels of alcohol consumption, on days when young adults drank, participants reported more in-person contacts compared to nondrinking days.
","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine, Stanford University, Palo Alto, California. Electronic address: suffbp@stanford.edu.'}, {'ForeName': 'Nilam', 'Initials': 'N', 'LastName': 'Ram', 'Affiliation': 'Department of Psychology and Department of Communication, Stanford University, Palo Alto, California.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry, Robert Wood Johnson School of Medicine, Rutgers University, Brunswick, New Jersey.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.08.007']
2830,32945153,"Pharmacokinetics, Safety, and Tolerability of Single- and Multiple-Dose Once-Daily Baricitinib in Healthy Chinese Subjects: A Randomized Placebo-Controlled Study.","The objective of this phase 1 study was to evaluate the pharmacokinetics, safety, and tolerability of baricitinib after single and multiple doses in healthy Chinese adults. Eligible subjects received a once-daily dose of baricitinib 2, 4, or 10 mg or placebo on day 1 (single dose) and days 4 through 10 for 7 consecutive days (multiple doses). Plasma pharmacokinetic samples were collected up to 48 hours after dosing on days 1 and 10, with predose samples collected before dosing on day 1 and days 4 through 10. Safety and tolerability were also assessed. Baricitinib was rapidly absorbed, reaching peak plasma concentrations within 0.5 to 1 hour (median). Plasma concentrations declined rapidly following the attainment of peak concentrations, with a mean terminal half-life of 5.7 to 7.3 hours. Steady-state plasma concentrations of baricitinib were achieved after the second day of once-daily dosing, with minimal accumulation of baricitinib in plasma (up to 10% increase in area under the plasma concentration-time curve). Single- and multiple-dose mean values for area under the plasma concentration-time curve from time zero to infinity and maximum plasma concentration appeared to increase in an approximately dose-proportional manner across the dose range. Single and multiple oral doses of once-daily baricitinib up to 10 mg were well tolerated by healthy Chinese subjects.",2020,Single and multiple oral doses of once-daily baricitinib up to 10 mg were well tolerated by healthy Chinese subjects.,"['healthy Chinese subjects', 'Healthy Chinese Subjects', 'healthy Chinese adults']","['Single- and Multiple-Dose Once-Daily Baricitinib', 'Placebo', 'baricitinib 2, 4, or 10 mg or placebo']","['Safety and tolerability', 'Pharmacokinetics, Safety, and Tolerability', 'peak plasma concentrations', 'pharmacokinetics, safety, and tolerability of baricitinib', 'Steady-state plasma concentrations of baricitinib', 'Plasma concentrations', 'Plasma pharmacokinetic samples']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",,0.0960647,Single and multiple oral doses of once-daily baricitinib up to 10 mg were well tolerated by healthy Chinese subjects.,"[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xiao Yan', 'Initials': 'XY', 'LastName': 'Sheng', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Payne', 'Affiliation': 'Medical Department, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Medical Department, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Medical Department, Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai, China.'}, {'ForeName': 'Yi Min', 'Initials': 'YM', 'LastName': 'Cui', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.868']
2831,32942192,Cluster randomized controlled trial (RCT) to support parental contact for children in out-of-home care.,"BACKGROUND
There is an identified need to improve the evidence-base in relation to contact visits for children in the out-of-home-care (OOHC) system, to ensure optimal outcomes.
OBJECTIVE
The aim of this cluster randomized controlled trial (RCT) was to test the effectiveness of a contact intervention for parents having supervised contact with children in long-term OOHC.
PARTICIPANTS
183 study children in 15 clusters (OOHC services) and their parent(s) were randomized to the intervention (8 clusters, 100 children) and control groups (7 clusters, 83 children) in three Australian jurisdictions.
SETTING
The manualized intervention consisted of increasing the preparation and support provided by caseworkers to parents before and after their contact visits.
METHOD
Interviews were conducted with carers, parents and caseworkers of the study children at baseline and nine months post-randomization. Interviews included standardized assessment tools measuring child and adult wellbeing and relationships, carer and caseworker ability to support contact, and contact visit cancellations by the parent.
RESULTS
Compared with controls, the intention-to-treat (ITT) analyses showed that fewer visits were cancelled by parents in the intervention group at follow-up (-10.27; 95 % CI: -17.04 to -3.50, p = .006). In addition, per-protocol (PP) analyses showed higher caseworker receptivity to contact (6.03; 95 % CI: 0.04-12.03, p = .04), and higher parent satisfaction with contact (7.41; 95 % CI: 0.70-14.11, p = .03) in the intervention group at follow-up.
CONCLUSIONS
While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits. The findings of the current study provide an important contribution to knowledge in an area where few RCTs have been completed, notwithstanding the null findings.",2020,"While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits.","['parents having supervised contact with children in long-term OOHC', 'children in out-of-home care', 'Interviews were conducted with carers, parents and caseworkers of the study children at baseline and nine months post-randomization', '183 study children in 15 clusters (OOHC services) and their parent(s']","['kC kContact intervention', 'contact intervention']","['standardized assessment tools measuring child and adult wellbeing and relationships, carer and caseworker ability to support contact, and contact visit cancellations by the parent', 'caseworker receptivity', 'child wellbeing']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",183.0,0.11973,"While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits.","[{'ForeName': 'Aino', 'Initials': 'A', 'LastName': 'Suomi', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia; Research School of Population Health, The Australian National University, Australia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Lucas', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia.'}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'McArthur', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Humphreys', 'Affiliation': 'Department of Social Work, The University of Melbourne, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Dobbins', 'Affiliation': 'School of Public Health and Community Medicine, The University of New South Wales, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Taplin', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia. Electronic address: stephanie.taplin@acu.edu.au.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104708']
2832,32947067,Perspectives of patients and health professionals on important factors influencing rehabilitation following acute pulmonary embolism: A multi-method study.,"BACKGROUND
International guidelines on pulmonary embolism (PE) management and rehabilitation have recently been published. However, the contained recommendation about an efficient follow-up strategy after PE is difficult for health care professionals to implement because limited research exists about what strategies are efficient.
OBJECTIVES
The study aimed to 1) describe and explore perspectives and experiences of health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions.
PATIENTS/METHODS
The study was a multi-method study, nested in a larger randomized controlled trial, combining data from two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention.
RESULTS
Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations. In terms of rehabilitation, repeatedly testing physical performance, resuming exercise under the guidance and support of specialized personnel, and access to peer support, were considered important for increasing motivation and self-efficacy for engaging in physical activity again.
CONCLUSIONS
This study offers suggestions for key elements to include in post-PE management and rehabilitation interventions, as well as the structuring of care. However, research still needs to be undertaken before solid recommendations for the content and structure of successful post-PE management and rehabilitation can be given.",2020,"Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations.","['two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention', 'acute pulmonary embolism']","['health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions']",[],"[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2882221', 'cui_str': 'Acute pulmonary embolism'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.070874,"Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations.","[{'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Rolving', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark; DEFACTUM, Corporate Quality, Central Denmark Region, Aarhus, Denmark. Electronic address: Nanna.Rolving@rm.dk.'}, {'ForeName': 'Jannie Rhod', 'Initials': 'JR', 'LastName': 'Bloch-Nielsen', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Barbara Christina', 'Initials': 'BC', 'LastName': 'Brocki', 'Affiliation': 'Department of Physical and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Andreasen', 'Affiliation': 'Department of Physical and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark; Public Health and Epidemiology Group, Department of Health, Science and Technology, Aalborg University, Denmark.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.016']
2833,32947480,"The 11th Trial of a Cardiovascular Clinical Trialist - Coronavirus-2, Part 3.",,2020,,[],[],[],[],[],[],,0.0214642,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, NY.'}]",Cardiology in review,['10.1097/CRD.0000000000000349']
2834,32948045,Comparison of the Effects of Visual and Auditory Distractions on Fistula Cannulation Pain among Older Patients Undergoing Hemodialysis: A Randomized Controlled Clinical Trial.,"Pain associated with fistula cannulation is a challenge for nurses who provide care to older patients undergoing hemodialysis. Several non-pharmacological methods have been suggested for relieving fistula cannulation pain, but the benefits of visual and auditory distraction methods among older patients undergoing hemodialysis have not been investigated yet. Therefore, this study aimed to compare the effects of visual and auditory distractions on fistula cannulation pain among older patients undergoing hemodialysis. This randomized controlled clinical trial was conducted on 120 older patients undergoing hemodialysis. They were randomly assigned to three groups of visual distraction, auditory distraction, and the control ( n = 40 in each group) using a simple random assignment method. The distraction interventions continued for three consecutive sessions and the numeric rating scale of pain severity was used for data collection. Descriptive and inferential statistics were used for data analysis using SPSS. It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p = 0.001). However, visual distraction had a better effect on the reduction of pain severity. Therefore, while both visual and auditory distractions reduced pain severity in older patients undergoing hemodialysis, visual distraction was more effective. Nurses are encouraged to incorporate visual distraction as a safe and non-pharmacologic technique into routine nursing care for reducing older patients' suffering and improving their wellbeing when fistula cannulation is performed.",2020,It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p = 0.001).,"['Older Patients Undergoing Hemodialysis', 'older patients undergoing hemodialysis', 'older patients undergoing', '120 older patients undergoing hemodialysis']","['Visual and Auditory Distractions', 'hemodialysis, visual distraction', 'fistula cannulation', 'visual and auditory distractions', 'visual distraction, auditory distraction, and the control']","['fistula cannulation pain', 'Fistula Cannulation Pain', 'Pain', 'numeric rating scale of pain severity', 'pain severity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",120.0,0.0398348,It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p = 0.001).,"[{'ForeName': 'Mina Ghadimi', 'Initials': 'MG', 'LastName': 'Aghbolagh', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Bahrami', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Rejeh', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Majideh', 'Initials': 'M', 'LastName': 'Heravi-Karimooi', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Seyed Davood', 'Initials': 'SD', 'LastName': 'Tadrisi', 'Affiliation': 'Trauma Research Center, Faculty of Nursing, Baqiyatallah University of Medical Sciences, Tehran 1435916471, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Vaismoradi', 'Affiliation': 'Faculty of Nursing and Health Sciences, Nord University, 8049 Bodø, Norway.'}]","Geriatrics (Basel, Switzerland)",['10.3390/geriatrics5030053']
2835,32950939,Feasibility and efficacy of a digital CBT intervention for symptoms of Generalized Anxiety Disorder: A randomized multiple-baseline study.,"BACKGROUND AND OBJECTIVES
Cognitive behavioral therapy (CBT) is a first-line treatment for anxiety, but it is not widely available as clinical guidelines recommend. We examined the feasibility and efficacy of a novel smartphone-based fully automated digital CBT intervention, 'Daylight™', to improve symptoms of Generalized Anxiety Disorder (GAD).
METHODS
In this multiple-baseline design, 21 adults (20 F; mean age 43yrs. range 19-65yrs.) with moderate-to-severe symptoms of GAD were randomized to one of three baseline durations (2-, 4-, or 6-weeks) and then received access to digital CBT. Participants completed daily ratings of anxiety and worry, weekly measures of anxiety, depressive symptoms, and sleep, and measures of anxiety, worry, wellbeing, quality of life, CBT skill acquisition, and work performance at initial assessment prior to baseline randomization, post-intervention, and follow-up.
RESULTS
Digital CBT was found to be feasible in terms of engagement, satisfaction, and safety. For preliminary efficacy, improvements were detected in daily and weekly outcomes of anxiety for most participants. Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline. Overall, 70% of participants no longer had clinically significant symptoms of GAD, 61% no longer had significant depressive symptoms, and 40% no longer had significant sleep difficulty at post-intervention.
LIMITATIONS
The study sample was recruited using the internet and was mostly female, limiting the generalizability of the findings.
CONCLUSIONS
Findings support the feasibility and efficacy of Daylight. Further examination in randomized controlled trials is now warranted.",2020,"Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline.","['21 adults (20\xa0F; mean age 43yrs', 'range 19-65yrs.) with moderate-to-severe symptoms of GAD', 'Generalized Anxiety Disorder']","['digital CBT intervention', ""novel smartphone-based fully automated digital CBT intervention, 'Daylight™"", 'Cognitive behavioral therapy (CBT']","['depressive symptoms', 'daily ratings of anxiety and worry, weekly measures of anxiety, depressive symptoms, and sleep, and measures of anxiety, worry, wellbeing, quality of life, CBT skill acquisition, and work performance at initial assessment prior to baseline randomization, post-intervention, and follow-up', 'Feasibility and efficacy', 'engagement, satisfaction, and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",21.0,0.0552773,"Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline.","[{'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Miller', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK. Electronic address: chris.miller@bighealth.com.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Davis', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stott', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Adrienne J', 'Initials': 'AJ', 'LastName': 'Heinz', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}, {'ForeName': 'Kate H', 'Initials': 'KH', 'LastName': 'Bentley', 'Affiliation': 'Derner School of Psychology, Adelphi University, Garden City, NY, USA.'}, {'ForeName': 'Guy M', 'Initials': 'GM', 'LastName': 'Goodwin', 'Affiliation': 'University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Bernard S', 'Initials': 'BS', 'LastName': 'Gorman', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Anxiety and Depression Research Centre (ADRC), UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Jenna R', 'Initials': 'JR', 'LastName': 'Carl', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101609']
2836,32950989,"Weight Loss, Dietary Preferences, and Reduction in the Sense of Smell with the Use of a Novel Nasal Device.","INTRODUCTION
Exposure to food odors are known to increase food intake. Olfaction declines from age 50 years.
OBJECTIVE
We examined changes in the sense of smell, body weight, food preferences, and parameters of metabolic status, following the use of a specially designed nasal device.
METHODS
This is a randomized, placebo-controlled study. Participants wore a nasal device (soft silicone insert) for 5-12 h daily (device group) or inserted 2 drops of normal saline into each nostril daily (control group). Follow-up visits occurred every 2 weeks. All participants were given a 500 kcal/day reduced diet and instructed not to change their regular physical activity. Weight, food preferences, olfactory sensitivity, and blood tests were performed at baseline and after 12 weeks.
RESULTS
Of 156 participants, 65 (42%) completed the study. Sense of smell decreased in the device group (from 6.4 ± 0.9 to 4.4 ± 1.5, on a scale of 0-7, p < 0.001), and did not change in the control group. Weight loss decreased by 6.6 ± 3.7% (p = 0.001) and by 5.7 ± 3.5% (p = 0.001) in the respective groups (between-group difference, p > 0.05). Among participants aged ≤50 years, weight loss was greater in the device than in the control group (7.7 ± 4.2% vs. 4.1 ± 2.9%, p = 0.02). Insulin level and the homeostatic model assessment of insulin resistance (HOMA-IR) were significantly reduced in the device group (p = 0.02 and p = 0.01, respectively), but not in the control group. Food preferences for sugar (p < 0.02), sweet beverages (p < 0.001), and artificial sweeteners (p < 0.02) were significantly reduced in the device group compared to the control group.
CONCLUSIONS
The use of a novel self-administrated nasal device led to reduced olfactory sensitivity, improved insulin sensitivity, weight loss, and lesser preference for sweets in adults aged ≤50 years.",2020,"Insulin level and the homeostatic model assessment of insulin resistance (HOMA-IR) were significantly reduced in the device group (p = 0.02 and p = 0.01, respectively), but not in the control group.","['Of 156 participants, 65 (42%) completed the study', 'adults aged ≤50 years']","['placebo', 'nasal device (soft silicone insert) for 5-12 h daily (device group) or inserted 2 drops of normal saline into each nostril daily (control group']","['Weight, food preferences, olfactory sensitivity, and blood tests', 'weight loss', 'artificial sweeteners', 'insulin sensitivity, weight loss, and lesser preference for sweets', 'Sense of smell', 'Insulin level and the homeostatic model assessment of insulin resistance (HOMA-IR', 'sweet beverages', 'Weight Loss, Dietary Preferences, and Reduction in the Sense of Smell', 'Weight loss']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0003920', 'cui_str': 'Artificial sweetener'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",,0.0873482,"Insulin level and the homeostatic model assessment of insulin resistance (HOMA-IR) were significantly reduced in the device group (p = 0.02 and p = 0.01, respectively), but not in the control group.","[{'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Dicker', 'Affiliation': 'Internal Medicine D and Obesity Clinic, Hasharon Hospital, Rabin Medical Center, Petach-Tikva, Israel, daniel3@013.net.'}, {'ForeName': 'Adva', 'Initials': 'A', 'LastName': 'Beck', 'Affiliation': 'Beck Medical, Givat-Ada, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Markel', 'Affiliation': 'Haemek Medical Center, Afula, Israel.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Marcovicu', 'Affiliation': 'Internal Medicine D and Obesity Clinic, Hasharon Hospital, Rabin Medical Center, Petach-Tikva, Israel.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Mazzawi', 'Affiliation': 'Otolaryngology Head and Neck Surgery, Haemek Medical Center, Rappaport School of Medicine, Technion, Israel.'}, {'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Sarid', 'Affiliation': 'Western Galilee College, Akko, Israel.'}, {'ForeName': 'Elhanan', 'Initials': 'E', 'LastName': 'Greenberg', 'Affiliation': 'Beck Medical, Givat-Ada, Israel.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Atkinson', 'Affiliation': 'Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.'}]",Obesity facts,['10.1159/000508976']
2837,32956419,Early antiretroviral therapy for HIV-infected patients admitted to an intensive care unit (EARTH-ICU): A randomized clinical trial.,"BACKGROUND
Highly active antiretroviral therapy (HAART) has reduced HIV-related morbidity and mortality at all stages of infection and reduced transmission of HIV. Currently, the immediate start of HAART is recommended for all HIV patients, regardless of the CD4 count. There are several concerns, however, about starting treatment in critically ill patients. Unpredictable absorption of medication by the gastrointestinal tract, drug toxicity, drug interactions, limited reserve to tolerate the dysfunction of other organs resulting from hypersensitivity to drugs or immune reconstitution syndrome, and the possibility that subtherapeutic levels of drug may lead to viral resistance are the main concerns. The objective of our study was to compare the early onset (up to 5 days) with late onset (after discharge from the ICU) of HAART in HIV-infected patients admitted to the ICU.
METHODS
This was a randomized, open-label clinical trial enrolling HIV-infected patients admitted to the ICU of a public hospital in southern Brazil. Patients randomized to the intervention group had to start treatment with HAART within 5 days of ICU admission. For patients in the control group, treatment should begin after discharge from the ICU. The patients were followed up to determine mortality in the ICU, in the hospital and at 6 months. The primary outcome was hospital mortality. The secondary outcome was mortality at 6 months.
RESULTS
The calculated sample size was 344 patients. Unfortunately, we decided to discontinue the study due to a progressively slower recruitment rate. A total of 115 patients were randomized. The majority of admissions were for AIDS-defining illnesses and low CD4. The main cause of admission was respiratory failure. Regarding the early and late study groups, there was no difference in hospital (66.7% and 63.8%, p = 0.75) or 6-month (68.4% and 79.2%, p = 0.20) mortality. After multivariate analysis, the only independent predictors of in-hospital mortality were shock and dialysis during the ICU stay. For the mortality outcome at 6 months, the independent variables were shock and dialysis during the ICU stay and tuberculosis at ICU admission.
CONCLUSIONS
Although the early termination of the study precludes definitive conclusions being made, early HAART administration for HIV-infected patients admitted to the ICU compared to late administration did not show benefit in hospital mortality or 6-month mortality. ClinicalTrials.gov, NCT01455688. Registered 20 October 2011, https://clinicaltrials.gov/show/NCT01455688.",2020,"Regarding the early and late study groups, there was no difference in hospital (66.7% and 63.8%, p = 0.75) or 6-month (68.4% and 79.2%, p = 0.20) mortality.","['HIV-infected patients admitted to the ICU of a public hospital in southern Brazil', '344 patients', 'HIV-infected patients admitted to the ICU', '115 patients were randomized', 'HIV-infected patients admitted to an intensive care unit (EARTH-ICU', 'critically ill patients']","['HAART', 'active antiretroviral therapy (HAART']","['mortality at 6 months', 'hospital mortality or 6-month mortality', 'hospital mortality', 'hospital']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0242744', 'cui_str': 'Earth (Planet)'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0887947', 'cui_str': 'Highly active anti-retroviral therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",115.0,0.135629,"Regarding the early and late study groups, there was no difference in hospital (66.7% and 63.8%, p = 0.75) or 6-month (68.4% and 79.2%, p = 0.20) mortality.","[{'ForeName': 'Márcio M', 'Initials': 'MM', 'LastName': 'Boniatti', 'Affiliation': 'Critical Care Department, Hospital de Clínicas de Porto Alegre, Universidade La Salle, Porto Alegre, Brazil.'}, {'ForeName': 'José Augusto S', 'Initials': 'JAS', 'LastName': 'Pellegrini', 'Affiliation': 'Critical Care Department, Hospital de Clínicas de Porto Alegre, Universidade La Salle, Porto Alegre, Brazil.'}, {'ForeName': 'Leonardo S', 'Initials': 'LS', 'LastName': 'Marques', 'Affiliation': 'Critical Care Department, Hospital Nossa Senhora da Conceição, Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Josiane F', 'Initials': 'JF', 'LastName': 'John', 'Affiliation': 'Critical Care Department, Hospital de Clínicas de Porto Alegre, Universidade La Salle, Porto Alegre, Brazil.'}, {'ForeName': 'Luiz G', 'Initials': 'LG', 'LastName': 'Marin', 'Affiliation': 'Critical Care Department, Hospital Nossa Senhora da Conceição, Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Lina R D M', 'Initials': 'LRDM', 'LastName': 'Maito', 'Affiliation': 'Critical Care Department, Hospital São Vicente de Paulo, Passo Fundo, Brazil.'}, {'ForeName': 'Thiago C', 'Initials': 'TC', 'LastName': 'Lisboa', 'Affiliation': 'Critical Care Department, Hospital de Clínicas de Porto Alegre, Instituto de Pesquisa HCor, Universidade La Salle, Porto Alegre, Brazil.'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Instituto de Pesquisa HCor, Sao Paulo, Brazil.'}, {'ForeName': 'Diego R', 'Initials': 'DR', 'LastName': 'Falci', 'Affiliation': 'Infectious Disease Department, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}]",PloS one,['10.1371/journal.pone.0239452']
2838,32971161,"Treatment of women's sexual dysfunction using Apium graveolens L. Fruit (celery seed): A double-blind, randomized, placebo-controlled clinical trial.","ETHNOPHARMACOLOGICAL RELEVANCE
Traditional manuscripts refer to plants such as Apium graveolens L. Fruit (celery seed), which could be used to improve sexual function among women. Since that time, local herbal shops in Iran continue to provide this herb as a natural aphrodisiac product.
AIM OF THE STUDY
This study aimed to evaluate the efficacy and safety of celery seed for the treatment of female sexual dysfunction.
METHODS AND MATERIALS
In this parallel, randomized, double-blinded clinical trial, 80 women were assigned to receive either 500 mg of celery seed or placebo 3 times a day for a period of 6 weeks (n = 40 per group). The female sexual function index (FSFI) questionnaire was used to evaluate women's sexual function before and after treatment.
RESULTS
At the end of the sixth week, an improvement in the total FSFI score was significantly greater in celery seed-treated women than those receiving the placebo (P < 0.001). Increased total FSFI score is mainly contributed by improvement in the sexual desire (p < 0.001), arousal (p < 0.001), lubrication (p < 0.001), and pain (p = 0.033) domains at the endpoint of study. No serious side effects were noticed in both groups during the study period.
CONCLUSION
It seems that celery seed improved sexual function in women and could be used as a safe, well-tolerated, and effective herbal medicine in women with sexual dysfunction.",2021,"At the end of the sixth week, an improvement in the total FSFI score was significantly greater in celery seed-treated women than those receiving the placebo (P<0.001).","['female sexual dysfunction', ""women's sexual dysfunction using Apium graveolens L. Fruit (celery seed"", 'women with sexual dysfunction', 'Traditional manuscripts refer to plants such as Apium graveolens L. Fruit (celery seed', '80 women']","['placebo', '500 mg of celery seed or placebo', 'Placebo']","['serious side effects', 'total FSFI score', 'efficacy and safety', 'arousal', 'female sexual function index (FSFI) questionnaire', 'sexual function', 'sexual desire', 'lubrication', 'pain']","[{'cui': 'C1112442', 'cui_str': 'Female sexual dysfunction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0996918', 'cui_str': 'Apium'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0453248', 'cui_str': 'Celery seed'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0453248', 'cui_str': 'Celery seed'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",80.0,0.412374,"At the end of the sixth week, an improvement in the total FSFI score was significantly greater in celery seed-treated women than those receiving the placebo (P<0.001).","[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran; Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Rahnavard', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ayda', 'Initials': 'A', 'LastName': 'Hosseinkhani', 'Affiliation': 'Research Center of Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Azima', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehrab', 'Initials': 'M', 'LastName': 'Sayadi', 'Affiliation': 'Department of Biostatistics, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Massoumeh', 'Initials': 'M', 'LastName': 'Emamghoreishi', 'Affiliation': 'Department of Pharmacology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Hessami', 'Affiliation': 'School of Pharmacy, International Branch, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: anna_hessami@yahoo.com.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Foroughinia', 'Affiliation': 'Box Hill Hospital, FRANZCOG, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Maasumeh Kaviani', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Roozmeh', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: nasadi2012@yahoo.ca.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113400']
2839,32971163,Episiotomy wound healing by Commiphora myrrha (Nees) Engl. and Boswellia carteri Birdw. in primiparous women: A randomized controlled trial.,"ETHNOPHARMACOLOGICAL RELEVANCE
Traditional Persian medicine manuscripts refer to plants such as Commiphora myrrha (Nees) Engl. (myrrh) and Boswellia carteri Birdw. (frankincense), which could be used to improve wound healing process. Since that time, local midwives in Iran continue to provide these herbs to precipitate episiotomy wound healing.
AIM OF THE STUDY
To investigate the efficacy and safety of myrrh- and frankincense-based sitz-baths on episiotomy wound healing in primiparous women.
MATERIALS AND METHODS
This randomized controlled trial was conducted on 90 primiparous women with singleton pregnancies after normal vaginal delivery at Hafez hospital affiliated to Shiraz University of Medical Sciences from July to October 2019. Study participants were randomly allocated in three groups (2 intervention groups and 1 control group). Women in intervention groups were assigned to receive either 10-min sitz-bath of myrrh extract or frankincense extract twice a day for 1 week. While the women in control group received the betadine sitz-bath for the same period of time. The main outcome was the episiotomy wound healing, which was measured using the REEDA scale before intervention, on 2nd and 7th postpartum days.
RESULTS
An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2nd (p = 0.003 and p < 0.001) and 7th (p = 0.043 and p = 0.015) postpartum days. However, the total REEDA score was not statistically different between the frankincense and betadine groups on 2nd and 7th postpartum days (p > 0.05).
CONCLUSION
The present results suggest that myrrh was more efficient than frankincense and betadine in healing of the episiotomy wound and could be recommended as a safe natural therapy.",2021,An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2 nd (p=0.003 and p<0.001) and 7 th (p=0.043 and p=0.015) postpartum days.,"['primiparous women', 'Traditional Persian medicine manuscripts refer to plants such as Commiphora myrrha (Nees) Engl', '90 primiparous women with singleton pregnancies after normal vaginal delivery at Hafez hospital affiliated to Shiraz University of Medical Sciences from July to October 2019']","['betadine sitz-bath', 'myrrh- and frankincense-based sitz-baths', 'betadine', '10-minute sitz-bath of myrrh extract or frankincense extract']","['total REEDA score', 'efficacy and safety', 'Episiotomy wound healing', 'episiotomy wound healing, which was measured using the REEDA scale', 'episiotomy wound healing']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C1536360', 'cui_str': 'Commiphora molmol'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0699524', 'cui_str': 'Betadine'}, {'cui': 'C0207011', 'cui_str': 'Myrrh extract'}, {'cui': 'C0949991', 'cui_str': 'Boswellia sacra'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3256678', 'cui_str': 'Frankincense extract'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",90.0,0.0403952,An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2 nd (p=0.003 and p<0.001) and 7 th (p=0.043 and p=0.015) postpartum days.,"[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: farajiaz@sums.ac.ir.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Aghdaki', 'Affiliation': 'Obstetrics and Gynecology Department, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: maryam.aghdaki@yahoo.com.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: hessamikamran@gmail.com.'}, {'ForeName': 'Ayda', 'Initials': 'A', 'LastName': 'Hosseinkhani', 'Affiliation': 'Thoracic and Vascular Surgery Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: hoseinkhan@sums.ac.ir.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Roozmeh', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: dr.roozmeh1995@yahoo.com.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: nasadi2012@yahoo.ca.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: vafaeih@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kasraeian', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: kasraeemm@yahoo.com.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'School of Nursing &Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: royakianbagheri64@gmail.com.'}, {'ForeName': 'Khadije', 'Initials': 'K', 'LastName': 'Bazrafshan', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: bazrafshan.kh@gmail.com.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Foroughinia', 'Affiliation': 'Box Hill Hospital, FRANZCOG, Eastern Health, Victoria, Australia. Electronic address: Foroughinialeila@yahoo.com.au.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113396']
2840,32971450,Improving the endothelial dysfunction in type 2 diabetes with chromium and vitamin D 3 byreducing homocysteine and oxidative stress: A randomized placebo-controlled trial.,"BACKGROUND
Chromium picolinate (CrPic) and vitamin D3 are known as two antioxidant micronutrients. Through inducing endothelial dysfunction, oxidants such as homocysteine (Hct) and malondialdehyde (MDA) lead to cardiovascular disease in type 2 diabetes mellitus (T2DM). No published data has directly examined the effects of these two antioxidants on improving the endothelial dysfunction in T2DM throughreducing homocysteine and oxidative stress.
METHODS
Subjects (n = 92) in this randomized, double blind, placebo-control study were randomly assigned to receive oral placebo (group I), D 3 (group II: 50,000 IU/ week), chromium picolinate (CrPic) (group III: 500 μg/day), and both vitamin D 3 and CrPic (group IV) for four months. Fasting blood samples were drawn at study baseline and following intervention to determine Hct, MDA, total antioxidant capacity (TAC), total thiol groups (SHs), vascular cell adhesion molecule- 1 (VCAM-1), and plasminogen activator inhibitor-1 (PAI-1).
RESULTS
After intervention, MDA significantly decreased in groups II and IV; TAC significantly increased in group IV, and SHs significantly augmented in group III; Hct was significantly reduced in groups II, III, and IV; and VCAM-1 significantly decreased in groups III and IV and PAI-1 was significantly reduced in groups II, III, and IV.
CONCLUSION
Our findings suggest that through reducing homocysteine and oxidative stress and improving endothelial dysfunction, chromium and vitamin D 3 co-supplementation might be predictive and preventive of cardiovascular diseasesassociated with T2DM. IRCT, IRCT20190610043852N1, registered 21 October 2019, https://fa.irct.ir/user/trial/42293/view.",2020,"After intervention, MDA significantly decreased in groups II and IV; TAC significantly increased in group IV, and SHs significantly augmented in group III; Hct was significantly reduced in groups II, III, and IV; and VCAM-1 significantly decreased in groups III and IV and PAI-1 was significantly reduced in groups II, III, and IV.
","['Subjects (n = 92', 'type 2 diabetes mellitus (T2DM']","['chromium and vitamin D', 'vitamin D 3 and CrPic', 'Chromium picolinate (CrPic) and vitamin D3', 'oral placebo', 'placebo', 'chromium picolinate (CrPic']","['MDA', 'VCAM-1', 'Hct, MDA, total antioxidant capacity (TAC), total thiol groups (SHs), vascular cell adhesion molecule', 'endothelial dysfunction, oxidants such as homocysteine (Hct) and malondialdehyde (MDA', 'Fasting blood samples', '1 (VCAM-1), and plasminogen activator inhibitor-1 (PAI-1', 'homocysteine and oxidative stress', 'endothelial dysfunction']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0163657', 'cui_str': 'CHROMIUM PICOLINATE'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.150688,"After intervention, MDA significantly decreased in groups II and IV; TAC significantly increased in group IV, and SHs significantly augmented in group III; Hct was significantly reduced in groups II, III, and IV; and VCAM-1 significantly decreased in groups III and IV and PAI-1 was significantly reduced in groups II, III, and IV.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Imanparast', 'Affiliation': 'Traditional and Complementary Medicine Research Center, Arak University of Medical Sciences, Arak, Iran; Department of Biochemistry, Khomein University of Medical Sciences, Khomein, Iran. Electronic address: Fatemeh.Imanparast@arakmu.ac.ir.'}, {'ForeName': 'Farideh Jalali', 'Initials': 'FJ', 'LastName': 'Mashayekhi', 'Affiliation': 'Department of Biochemistry and Genetics, Faculty of Medicine, Arak University of Medical Sciences, Arak, Iran; Department of Laboratory Sciences, Faculty of Paramedicine, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Kamankesh', 'Affiliation': 'Department of Biochemistry, Khomein University of Medical Sciences, Khomein, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rafiei', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pegah', 'Initials': 'P', 'LastName': 'Mohaghegh', 'Affiliation': 'Community and Preventive Medicine Specialist, Department of community medicine, Faculty of Medicine, Arak University of Medical Sciences, Arak,Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Alimoradian', 'Affiliation': 'Department of Pharmacology, School of Medicine, Arak University of Medical Sciences, Arak, Iran.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126639']
2841,32972868,Pilot of Brief Health Coaching Intervention to Improve Adherence to Positive Airway Pressure Therapy.,"BACKGROUND
Adherence to positive airway pressure (PAP) therapies is poor, particularly among low-income populations and racial minorities. This study tested a low-resource, brief telephonic health coaching intervention to improve PAP adherence.
METHODS
Post hoc analysis of a quality improvement initiative in which English- and Spanish-speaking patients from a county-based public health system were randomly assigned to receive health coaching or usual care. An unlicensed, trained health coach called patients three times to resolve barriers to adherence. A per-protocol analysis was conducted for adherence measures collected by device modem at baseline and 30 days.
RESULTS
Of 131 people for whom device data were available, 56 were randomized to health coaching and 75 to usual care. At baseline, 47.3% of patients had used their device at any time in the past 30 days, with a mean of 2 hours of use per night. At 30 days, adjusting for baseline, patients in the coaching arm were more likely than usual care patients to use their device (55.4% vs. 41.3%, p = 0.03), and they increased their use for 0.4 hours over usual care (p = 0.04).
CONCLUSION
This pilot study suggests that a low-cost intervention could be effective at improving PAP adherence, even in a population known to have poor adherence and among long-term PAP users with poor adherence. Future research may examine whether a higher-touch intervention or one using videoconferencing yields greater improvements. This promising intervention warrants further study.",2020,"At 30 days, adjusting for baseline, patients in the coaching arm were more likely than usual care patients to use their device (55.4% vs. 41.3%, p = 0.03), and they increased their use for 0.4 hours over usual care (p = 0.04).
","['131 people for whom device data were available', 'English- and Spanish-speaking patients from a county-based public health system']","['health coaching and 75 to usual care', 'telephonic health coaching intervention', 'positive airway pressure (PAP) therapies', 'health coaching or usual care', 'Brief Health Coaching Intervention']",['PAP adherence'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0681401,"At 30 days, adjusting for baseline, patients in the coaching arm were more likely than usual care patients to use their device (55.4% vs. 41.3%, p = 0.03), and they increased their use for 0.4 hours over usual care (p = 0.04).
","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Willard-Grace', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': ''}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Eula', 'Initials': 'E', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Su', 'Affiliation': ''}]",Joint Commission journal on quality and patient safety,['10.1016/j.jcjq.2020.08.011']
2842,32973117,Sentinel lymph node biopsy versus pelvic lymphadenectomy in early-stage cervical cancer: a multi-center randomized trial (PHENIX/CSEM 010).,"BACKGROUND
There is no accepted strategy for applying sentinel lymph node (SLN) biopsy as an alternative to pelvic lymphadenectomy in cervical cancer. It is unclear whether and when pelvic lymphadenectomy can be safely replaced by SLN biopsy alone.
PRIMARY OBJECTIVE
To comprehensively compare the oncological outcomes of SLN biopsy with pelvic lymphadenectomy in patients with and without SLN metastasis.
STUDY HYPOTHESIS
It is hypothesized that the oncological outcomes provided by SLN biopsy are non-inferior to those of pelvic lymphadenectomy in patients with clinically early-stage cervical cancer if risk-adapted adjuvant treatments are given.
TRIAL DESIGN
All eligible patients will undergo SLN biopsy at the start of surgery. The resected SLNs will be submitted for frozen section examination. and patients will be triaged into the PHENIX-I (SLN-negative) or PHENIX-II (SLN-positive) cohort. In each cohort of this trial, patients will be randomized in a 1:1 ratio into the experimental (SLN biopsy alone) or reference (pelvic lymphadenectomy) arm. Radical hysterectomy will be performed for all patients, and adjuvant treatments will be planned according to post-operative pathological factors.
MAJOR INCLUSION/EXCLUSION CRITERIA
Patients aged between 18 and 65 years with histologically confirmed, untreated stage IA1 (lymphovascular space involvement), IA2, IB1, and IB2 cervical squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma.
PRIMARY ENDPOINT
The primary endpoint is disease-free survival.
SAMPLE SIZE
Estimated sample sizes of 830 and 250 are required to fulfill the study objectives of PHENIX-I and II, respectively.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS
As of May 2020, more than 600 eligible patients have been enrolled. Enrollment is expected to be completed by December 2022, and presentation of results is expected in 2026.
TRIAL REGISTRATION
NCT02642471.",2020,"BACKGROUND
There is no accepted strategy for applying sentinel lymph node (SLN) biopsy as an alternative to pelvic lymphadenectomy in cervical cancer.","['early-stage cervical cancer', 'patients with clinically early-stage cervical cancer', 'All eligible patients will undergo SLN biopsy at the start of surgery', '600 eligible patients have been enrolled', 'patients with and without SLN metastasis', 'Patients aged between 18 and 65 years with histologically confirmed, untreated stage IA1 (lymphovascular space involvement), IA2, IB1, and IB2 cervical squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma']","['pelvic lymphadenectomy', 'Radical hysterectomy', 'Sentinel lymph node biopsy versus pelvic lymphadenectomy', 'experimental (SLN biopsy alone) or reference (pelvic lymphadenectomy', 'SLN biopsy with pelvic lymphadenectomy']",['disease-free survival'],"[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0458828', 'cui_str': 'Stage 1A1'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0206623', 'cui_str': 'Adenosquamous carcinoma'}]","[{'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",,0.17339,"BACKGROUND
There is no accepted strategy for applying sentinel lymph node (SLN) biopsy as an alternative to pelvic lymphadenectomy in cervical cancer.","[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Tu', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Bingna', 'Initials': 'B', 'LastName': 'Xian', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Jibin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Clinical Trial Center, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecology, West China Second University Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Gynecologic Oncology, Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Gynecologic Oncology, Obstetrics & Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ""Department of Gynecologic Oncology, Women's Hospital of Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecologic Oncology, Liaoning Cancer Hospital, Shenyang, China.'}, {'ForeName': 'Beihua', 'Initials': 'B', 'LastName': 'Kong', 'Affiliation': 'Department of Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Department of Gynecology, Guangdong Province Traditional Chinese Medical Hospital, Guangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China liujih@mail.sysu.edu.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001857']
2843,32931400,"Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy: Investigator-Initiated, Randomized, Open-Label Trial.","PURPOSE
Chemotherapy-induced nausea and vomiting (CINV) is a significant toxicity of chemotherapy. Olanzapine is recommended in adult patients for the prevention of CINV but has not been prospectively investigated in children.
METHODS
This investigator-initiated, randomized, open-label trial evaluated olanzapine in children (ages 5-18 years) scheduled to receive the first cycle of highly emetogenic chemotherapy (HEC). All participants received aprepitant, ondansetron, and dexamethasone during and 2 days after chemotherapy. Participants in the study group additionally received oral olanzapine 0.14 mg/kg/day (rounded to the nearest 2.5 mg; maximum, 10 mg) during the chemotherapy block and 3 days postchemotherapy. The primary objective was to compare complete response (CR) rates (no vomiting and no rescue medication) between the groups in the acute, delayed, and overall periods. Nausea comparison and safety evaluation were secondary and additional objectives, respectively. The collection of outcomes and adverse events was performed daily until the completion of the overall period.
RESULTS
A total of 240 patients underwent randomization. We performed a modified intention-to-treat analysis on 231 patients (116 in the control group and 115 in the study group). A higher proportion of patients in the olanzapine group achieved CR in the acute period (78% v 59%; P = .001), delayed period (74% v 47%; P < .001) and overall period (64% v 38%; P < .001) than in the control group. The proportion of patients with no nausea was significantly higher in the olanzapine group in the acute period (74% v 52%; P < .001), delayed period (74% v 47%; P < .001), and overall period (64% v 37%; P < .001). Grade 1/2 somnolence was greater in the olanzapine group (35% v 11%; P < .001). There was no grade 3/4 somnolence reported.
CONCLUSION
Olanzapine significantly improved CR rates for vomiting in children receiving the first cycle of HEC.",2020,"74% v 52%; P < .001), delayed period (74% v 47%; P < .001), and overall period (64% v 37%; P < .001).","['children (ages 5-18 years', 'children receiving the first cycle of HEC', 'adult patients', '240 patients underwent randomization', 'Children and Adolescents Receiving Highly Emetogenic Chemotherapy', '231 patients (116 in the control group and 115 in the study group']","['olanzapine', 'chemotherapy block and 3 days postchemotherapy', 'Olanzapine', 'aprepitant, ondansetron, and dexamethasone', 'oral olanzapine', 'emetogenic chemotherapy (HEC']","['complete response (CR) rates (no vomiting and no rescue medication', 'Vomiting', 'nausea and vomiting (CINV', 'proportion of patients with no nausea', 'Nausea comparison and safety evaluation', 'CR rates for vomiting', 'Grade 1/2 somnolence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0303407', 'cui_str': 'Indium-115'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0375548', 'cui_str': 'No vomiting'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0423584', 'cui_str': 'No nausea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",240.0,0.111181,"74% v 52%; P < .001), delayed period (74% v 47%; P < .001), and overall period (64% v 37%; P < .001).","[{'ForeName': 'Ramavath D', 'Initials': 'RD', 'LastName': 'Naik', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sreenivas', 'Initials': 'S', 'LastName': 'V', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashwati S', 'Initials': 'AS', 'LastName': 'Pillai', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Dhawan', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00871']
2844,32931412,Iron supplementation limits the deleterious effects of repeated blood donation on endurance sport performance but not on iron status.,"BACKGROUND
Every day, blood banks worldwide face the challenge of ensuring an adequate blood supply. Iron deficiency is by far the most common cause of deferral of blood donors. The aim of the present study was to determine the effect of iron supplementation after repeated blood donation on iron status and physiological performance.
MATERIALS AND METHODS
Forty-four moderately trained and iron-replete subjects were randomly divided into a whole blood donation (n=36) and a placebo donation (n=8) group. One third of the donation group received no iron supplementation, whereas one third received 20 mg iron and one third received 80 mg iron daily for 28 days. The subjects were intended to make three donations 3 months apart, and recovery of endurance capacity, assessed by an incremental maximal cycling test, and haematological parameters was monitored up to 28 days after each donation.
RESULTS
Negative effects of repeated blood donation were found for markers of iron storage, markers of functional iron and/or iron metabolism regulation, and physiological markers. Iron supplementation did not affect iron storage but did limit, at the highest dose of 80 mg, the effect of blood donations on functional iron and/or iron metabolism regulation, and at both 20 and 80 mg the negative effects on maximal power output and peak oxygen consumption.
DISCUSSION
Iron supplementation limited the deleterious effects of repeated blood donation on endurance sport performance but not on decline in iron status in iron-replete young men. These results underline the importance of iron supplementation to minimise the deleterious effects of blood donation on physiological functions, and the necessity to optimise the supplementation strategy to preserve iron status.",2020,"RESULTS
Negative effects of repeated blood donation were found for markers of iron storage, markers of functional iron and/or iron metabolism regulation, and physiological markers.","['Forty-four moderately trained and iron-replete subjects', 'iron-replete young men']","['no iron supplementation', 'iron supplementation', 'placebo donation', 'whole blood donation']","['maximal power output and peak oxygen consumption', 'endurance sport performance', 'functional iron and/or iron metabolism regulation', 'markers of iron storage, markers of functional iron and/or iron metabolism regulation, and physiological markers']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",44.0,0.129808,"RESULTS
Negative effects of repeated blood donation were found for markers of iron storage, markers of functional iron and/or iron metabolism regulation, and physiological markers.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pachikian', 'Affiliation': 'Centre of Investigation in Clinical Nutrition, UCLouvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Naslain', 'Affiliation': 'Institute of Neuroscience, UCLouvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Benoit', 'Affiliation': 'Institute of Neuroscience, UCLouvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Brebels', 'Affiliation': 'Institute of Neuroscience, UCLouvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Van Asch', 'Affiliation': 'Belgian Red Cross-Flanders, Mechelen, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Compernolle', 'Affiliation': 'Belgian Red Cross-Flanders, Mechelen, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Vandekerckhove', 'Affiliation': 'Belgian Red Cross-Flanders, Mechelen, Belgium.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Deldicque', 'Affiliation': 'Centre of Investigation in Clinical Nutrition, UCLouvain, Louvain-la-Neuve, Belgium.'}]",Blood transfusion = Trasfusione del sangue,['10.2450/2020.0087-20']
2845,32938481,Examining fidelity in the INFORM trial: a complex team-based behavioral intervention.,"BACKGROUND
Fidelity in complex behavioral interventions is underexplored. This study examines the fidelity of the INFORM trial and explores the relationship between fidelity, study arm, and the trial's primary outcome-care aide involvement in formal team communications about resident care.
METHODS
A concurrent process evaluation of implementation fidelity was conducted in 33 nursing homes in Western Canada (Alberta and British Columbia). Study participants were from 106 clinical care units clustered in 33 nursing homes randomized to the Basic and Enhanced-Assisted Feedback arms of the INFORM trial.
RESULTS
Fidelity of the INFORM intervention was moderate to high, with fidelity delivery and receipt higher than fidelity enactment for both study arms. Higher enactment teams experienced a significantly larger improvement in formal team communications between baseline and follow-up than lower enactment teams (F(1, 70) = 4.27, p = .042).
CONCLUSIONS
Overall fidelity enactment was associated with improvements in formal team communications, but the study arm was not. This suggests that the intensity with which an intervention is offered and delivered may be less important than the intensity with which intervention participants enact the core components of an intervention. Greater attention to fidelity assessment and publication of fidelity results through studies such as this one is critical to improving the utility of published trials.",2020,"Higher enactment teams experienced a significantly larger improvement in formal team communications between baseline and follow-up than lower enactment teams (F(1, 70) =","['Study participants were from 106 clinical care units clustered in 33 nursing homes randomized to the Basic and Enhanced-Assisted Feedback arms of the INFORM trial', '33 nursing homes in Western Canada (Alberta and British Columbia']",[],['formal team communications'],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}]",[],"[{'cui': 'C0009452', 'cui_str': 'Communication'}]",,0.113839,"Higher enactment teams experienced a significantly larger improvement in formal team communications between baseline and follow-up than lower enactment teams (F(1, 70) =","[{'ForeName': 'Liane R', 'Initials': 'LR', 'LastName': 'Ginsburg', 'Affiliation': 'School of Health Policy & Management, Faculty of Health, York University, Toronto, Ontario, M3J 1P3, Canada. lgins@yorku.ca.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hoben', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Alberta, T6G 1C9, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Easterbrook', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Alberta, T6G 1C9, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Andersen', 'Affiliation': 'School of Nursing, Thompson Rivers University, Kamloops, British Columbia, V2C 0C8, Canada.'}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Anderson', 'Affiliation': 'School of Nursing, University of North Carolina, Chapel Hill, North Carolina, 27599-7460, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cranley', 'Affiliation': 'Lawrence S Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, M5T 1P8, Canada.'}, {'ForeName': 'Holly J', 'Initials': 'HJ', 'LastName': 'Lanham', 'Affiliation': 'University of Texas Health Science Center San Antonio, University of Texas, San Antonio, Texas, 78229, USA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Norton', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, Alberta, T2N 4\u2009N1, Canada.'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'Weeks', 'Affiliation': 'School of Nursing, Faculty of Health, Dalhousie University, Halifax, Nova Scotia, B3H 4R2, Canada.'}, {'ForeName': 'Carole A', 'Initials': 'CA', 'LastName': 'Estabrooks', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Alberta, T6G 1C9, Canada.'}]",Implementation science : IS,['10.1186/s13012-020-01039-2']
2846,32942294,The effects of pre-intervention mindset induction on a brief intervention to increase risk perception and reduce alcohol use among university students: A pilot randomized controlled trial.,"OBJECTIVE
Brief interventions based on personalized feedback have shown promising results in reducing risky alcohol use among university students. We investigated the effects of activating deliberative (predecisional) or implemental (postdecisional) mindsets on the effectiveness of a standardized brief intervention, the ASSIST-linked Brief Intervention. This intervention comprises a personalized feedback and a decisional balance exercise. We hypothesized that participants in a deliberative mindset should show better outcomes related to risk perception and behavior than participants in an implemental mindset.
METHODS
A sample of 257 students provided baseline measures on risk perception, readiness to change, and alcohol use. Of those, 64 students with risky alcohol use were randomly allocated to one of two mindset induction conditions-deliberative or implemental mindset. Thereafter, they received the ASSIST-linked Brief Intervention and completed self-report questionnaires on changes in risk perception, alcohol use, and readiness to change at post-intervention and four-week follow-up.
RESULTS
In contrast to our hypotheses, the four-weeks follow-up revealed that participants in the implemental mindset consumed significantly less alcohol than participants in a deliberative mindset did. The former decreased and the latter increased their alcohol intake; resistance to the brief intervention was stronger in the latter condition. However, neither deliberative nor implemental mindset participants showed any changes in risk perceptions or in their readiness to change alcohol consumption.
CONCLUSIONS
These findings suggest that mindset induction is a powerful moderator of the effects of the ASSIST-linked Brief Intervention. We argue that systematic research on mindset effects on brief intervention techniques aimed to reduce risky alcohol use is highly needed in order to identify the processes involved with commitment and resistance being the main candidates.",2020,"However, neither deliberative nor implemental mindset participants showed any changes in risk perceptions or in their readiness to change alcohol consumption.
","['64 students with risky alcohol use', '257 students', 'university students']","['activating deliberative (predecisional) or implemental (postdecisional) mindsets', 'mindset induction conditions-deliberative or implemental mindset']","['risk perceptions', 'alcohol intake; resistance', 'risk perception and behavior', 'risk perception, readiness to change, and alcohol use', 'risk perception']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",257.0,0.0171764,"However, neither deliberative nor implemental mindset participants showed any changes in risk perceptions or in their readiness to change alcohol consumption.
","[{'ForeName': 'Natascha', 'Initials': 'N', 'LastName': 'Büchele', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Keller', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Anja C', 'Initials': 'AC', 'LastName': 'Zeller', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Freya', 'Initials': 'F', 'LastName': 'Schrietter', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Treiber', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Gollwitzer', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Odenwald', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}]",PloS one,['10.1371/journal.pone.0238833']
2847,32945993,Rare genetic variants suggest dysregulation of signaling pathways in low- and high-risk patients developing severe ovarian hyperstimulation syndrome.,"PURPOSE
To investigate if rare gene variants in women with severe ovarian hyperstimulation syndrome (OHSS) provide clues to the mechanisms involved in the syndrome.
METHODS
Among participants in a prospective randomized study (Toftager et al. 2016), six women with predicted low and six women with predicted high risk of OHSS developing severe OHSS (grades 4 and 5, Golan classification) were selected. In the same cohort, six plus six matched controls developing no signs of OHSS (Golan grade 0) were selected. Whole-exome sequencing was performed. Analysis using a predefined in silico OHSS gene panel, variant filtering, and pathway analyses was done.
RESULTS
We found no convincing monogenetic association with the development of OHSS using the in silico gene panel. Pathway analysis of OHSS variant lists showed substantial overlap in highly enriched top pathways (p value range p < 0.0001 and p > 9.8E-17) between the low- and high-risk group developing severe OHSS, i.e., ""the integrin-linked kinase (ILK) signaling pathway"" and the ""axonal guidance signaling pathway,"" both being connected to vasoactive endothelial growth factor (VEGF) and endothelial function.
CONCLUSION
Rare variants in OHSS cases with two distinct risk profiles enrich the same signaling pathways linked to VEGF and endothelial function. Clarification of the mechanism as well as potentially defining genetic predisposition of the high vascular permeability is important for future targeted treatment and prevention of OHSS; the potential roles of ILK signaling and the axonal guidance signaling need to be validated by functional studies.",2020,"Pathway analysis of OHSS variant lists showed substantial overlap in highly enriched top pathways (p value range p < 0.0001 and p > 9.8E-17) between the low- and high-risk group developing severe OHSS, i.e., ""the integrin-linked kinase (ILK) signaling pathway"" and the ""axonal guidance signaling pathway,"" both being connected to vasoactive endothelial growth factor (VEGF) and endothelial function.
","['women with severe ovarian hyperstimulation syndrome (OHSS', '2016), six women with predicted low and six women with predicted high risk of OHSS developing severe OHSS (grades 4 and 5, Golan classification) were selected']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]",[],[],6.0,0.0363445,"Pathway analysis of OHSS variant lists showed substantial overlap in highly enriched top pathways (p value range p < 0.0001 and p > 9.8E-17) between the low- and high-risk group developing severe OHSS, i.e., ""the integrin-linked kinase (ILK) signaling pathway"" and the ""axonal guidance signaling pathway,"" both being connected to vasoactive endothelial growth factor (VEGF) and endothelial function.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Borgwardt', 'Affiliation': 'Centre for Genomic Medicine, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. Line.gutte.borgwardt@regionh.dk.'}, {'ForeName': 'K W', 'Initials': 'KW', 'LastName': 'Olsen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Copenhagen University Hospital, Herlev, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rossing', 'Affiliation': 'Centre for Genomic Medicine, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'R Borup', 'Initials': 'RB', 'LastName': 'Helweg-Larsen', 'Affiliation': 'Functional Genomics and Reproductive Health Group, Faculty of Health and Medical Sciences- Copenhagen University, Copenhagen, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Toftager', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bogstad', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Løssl', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zedeler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Grøndahl', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Copenhagen University Hospital, Herlev, Denmark.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-020-01941-0']
2848,32946700,"Gender, having a positive FIT and type of hospital are important factors for colonoscopy experience in colorectal cancer screening - findings from the SCREESCO study.","OBJECTIVES
Assessing the experience of screening procedures is crucial for improving the quality and acceptance of colonoscopy in colorectal cancer screening. The aim of the study was to investigate the colonoscopy experience and associated factors among individuals who underwent a colonoscopy in the Screening of Swedish Colons (SCREESCO) study.
METHODS
Participants in the Screening of Swedish Colons (SCREESCO; n = 7593) randomized clinical trial (colonoscopy vs. faecal immunochemical test (FIT)) were enrolled. The primary outcome was overall colonoscopy experience measured with a study-specific questionnaire. Secondary endpoints were measured using multiple regression analyses with factors that included sex, randomization group, geographical regions, university hospital, complications, sedation, clean bowel, time to cecum, and presence of polyps or cancer.
RESULTS
A total of 6572 (87%) individuals responded to the questionnaire. The majority was satisfied with the information, care and treatment. Women reported more worry, discomfort and pain, but also better information, care and treatment compared with men. The FIT group was more worried and perceived more discomfort and pain than the colonoscopy group. Type of hospital (geographical region; university hospital vs. not university hospital) was also a significant predictor for the colonoscopy experience.
CONCLUSIONS
Although most participants were satisfied with the colonoscopy experience, the study has highlighted areas for improvement. Important factors for colonoscopy experience were gender, randomization group, and type of hospital and therefore crucial to bear in mind when designing screening programs.",2020,"Type of hospital (geographical region; university hospital vs. not university hospital) was also a significant predictor for the colonoscopy experience.
","['A total of 6572 (87%) individuals responded to the questionnaire', 'Type of hospital (geographical region; university hospital vs. not university hospital', 'Participants in the Screening of Swedish Colons (SCREESCO; n \u2009=\u20097593) randomized clinical trial (colonoscopy vs. faecal immunochemical test (FIT)) were enrolled', 'individuals who underwent a colonoscopy in the Screening of Swedish Colons (SCREESCO) study']",[],"['overall colonoscopy experience measured with a study-specific questionnaire', 'discomfort and pain', 'geographical regions, university hospital, complications, sedation, clean bowel, time to cecum, and presence of polyps or cancer', 'worry, discomfort and pain']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0233481', 'cui_str': 'Worried'}]",7593.0,0.0690388,"Type of hospital (geographical region; university hospital vs. not university hospital) was also a significant predictor for the colonoscopy experience.
","[{'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Fritzell', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Forsberg', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Wangmar', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Wengström', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bottai', 'Affiliation': 'Division of Biostatics, Institution of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Hultcrantz', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Sweden.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2020.1820568']
2849,32946806,Failure to Improve Verbal Fluency with Transcranial Direct Current Stimulation.,"Previous studies in healthy populations have provided equivocal evidence whether the application of anodal transcranial direct current stimulation (tDCS) over the left prefrontal cortex (PFC) can improve performance in verbal fluency tasks. In this double-blind, randomised within-participant study, we investigated whether anodal tDCS over the left PFC improves verbal fluency performance relative to sham tDCS. Forty eight healthy native German speakers performed two verbal fluency tasks after having received 20 min of anodal or sham tDCS over the left PFC. During stimulation, participants performed a picture naming task, which was expected to increase neuronal activity in the targeted region. We found no modulation of verbal fluency performance following anodal tDCS, with virtually identical overall scores across tDCS conditions. Furthermore, initiation time (i.e., time to produce the first correct utterance) was not affected by tDCS. As an unexpected finding, picture naming latencies were significantly longer during anodal compared to sham tDCS. Yet, changes in the naming task were not predictive of performance changes in the fluency task. Overall, the current study found no evidence that verbal fluency performance in healthy speakers could be improved by excitatory stimulation of the left PFC. We argue that previously observed positive effects could be false positives and should be interpreted with caution. The findings from the current study thus cast further doubt on the utility of tDCS in enhancing cognitive performance in the healthy (young) brain.",2020,"We found no modulation of verbal fluency performance following anodal tDCS, with virtually identical overall scores across tDCS conditions.","['healthy speakers', 'Forty eight healthy native German speakers', 'healthy (young) brain', 'healthy populations']","['verbal fluency tasks after having received 20\u202fmin of anodal or sham tDCS', 'anodal transcranial direct current stimulation (tDCS', 'anodal tDCS', 'tDCS']","['cognitive performance', 'Verbal Fluency', 'verbal fluency tasks', 'picture naming latencies', 'neuronal activity', 'verbal fluency performance', 'Furthermore, initiation time (i.e., time to produce the first correct utterance']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",48.0,0.0992325,"We found no modulation of verbal fluency performance following anodal tDCS, with virtually identical overall scores across tDCS conditions.","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Klaus', 'Affiliation': 'Lise Meitner Research Group Cognition and Plasticity, Max Planck Institute for Human Cognitive and Brain Sciences, Stephanstrasse 1A, 04103 Leipzig, Germany. Electronic address: j.klaus@uu.nl.'}, {'ForeName': 'Gesa', 'Initials': 'G', 'LastName': 'Hartwigsen', 'Affiliation': 'Lise Meitner Research Group Cognition and Plasticity, Max Planck Institute for Human Cognitive and Brain Sciences, Stephanstrasse 1A, 04103 Leipzig, Germany.'}]",Neuroscience,['10.1016/j.neuroscience.2020.09.003']
2850,32948120,"Sing4Health: protocol of a randomized controlled trial of the effects of a singing group intervention on the well-being, cognitive function and health of older adults.","BACKGROUND
Singing is a multimodal activity that requires physical, cognitive and psychosocial performance, with benefits to various domains of well-being and health in older adults. In recent years, research has increasingly studied group singing as an important cost-effective intervention to promote active and healthy aging. However, the specific factors responsible for these benefits need further experimental support, as most studies do not allow for causal inferences. This study responds to the need for further randomized controlled trials (RCT), with follow-up measurement, on the benefits of group singing in older adults from a low socioeconomic background. Also, while most studies often focus on specific outcome measure dimensions, in this study, the conjoint effect of several physical, psychosocial, psychoemotional and cognitive dimensions are analyzed, testing mediation effects of psychosocial and psychoemotional variables on the well-being and health of the participants.
METHODS
We implement and measure the effects of a singing group program for older adults, with an RCT crossover design study, in a natural context, before and after the intervention and in a follow-up, 6 months after the intervention.
PARTICIPANTS
140 retired older adults (> 60 years) users of a social support institution, will be invited to participate in a singing group program and randomly allocated to an experimental (n = 70) and a control (n = 70) group, which will enroll in the regular activities proposed by the institution. The intervention consists of 34 bi-weekly group singing sessions, of 2 h each, for 4 months. Measures on social and emotional well-being, cognitive function, and health indicators (e.g., blood pressure, glycemia, cholesterol, c-reactive protein, sedimentation rate, respiratory function, body balance, sleep quality, medication intake, and health services attendance) will be collected. Interviews will be conducted on the motivation and perceived benefits of participation.
DISCUSSION
Significant improvements are expected in the outcome measures in the experimental group after the intervention, validating singing groups as a cost-effective intervention for healthy aging. Psychosocial and psychoemotional variables are expected to be mediators of the effects of the program in the cognitive function, well-being and health of the participants.
TRIAL REGISTRATION
NCT03985917 . Registered 14th June 2019 (retrospectively registered).",2020,"DISCUSSION
Significant improvements are expected in the outcome measures in the experimental group after the intervention, validating singing groups as a cost-effective intervention for healthy aging.","['older adults', '140 retired older adults (>\u200960\u2009years) users of a social support institution, will be invited to participate in a singing group program', 'older adults from a low socioeconomic background', 'healthy aging']","['singing group intervention', 'singing group program']","['social and emotional well-being, cognitive function, and health indicators (e.g., blood pressure, glycemia, cholesterol, c-reactive protein, sedimentation rate, respiratory function, body balance, sleep quality, medication intake, and health services attendance']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C2963171', 'cui_str': 'Healthy Ageing'}]","[{'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0325504,"DISCUSSION
Significant improvements are expected in the outcome measures in the experimental group after the intervention, validating singing groups as a cost-effective intervention for healthy aging.","[{'ForeName': 'Iolanda Costa', 'Initials': 'IC', 'LastName': 'Galinha', 'Affiliation': 'Centro de Investigação em Psicologia (CIP), da Universidade Autónoma de Lisboa / Universidade do Algarve, CIS-ISTE-IUL; APPSYCI, Rua de Santa Marta, 47, 3° (Room, 304), 1169-023, Lisbon, Portugal. igalinha@autonoma.pt.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Farinha', 'Affiliation': 'Centro de Investigação em Psicologia (CIP), da Universidade Autónoma de Lisboa / Universidade do Algarve from Rua de Santa Marta, 47, 3° (Room, 304), 1169-023, Lisbon, Portugal.'}, {'ForeName': 'Maria Luísa', 'Initials': 'ML', 'LastName': 'Lima', 'Affiliation': 'ISCTE CIS IUL, Av. das Forças Armadas, ISCTE-IUL building, 2w17 Room, 1649-026, Lisbon, Portugal.'}, {'ForeName': 'António Labisa', 'Initials': 'AL', 'LastName': 'Palmeira', 'Affiliation': 'Universidade de Lisboa & Universidade Lusófona de Humanidades e Tecnologias, Campo Grande, 376, 1749-024, Lisbon, Portugal.'}]",BMC geriatrics,['10.1186/s12877-020-01686-6']
2851,32950505,Social media use while listening to new material negatively affects short-term memory in college students.,"Increased access to electronic devices and the ubiquity of social media has resulted in a rapid rise in the prevalence of students ""multitasking"" while in a classroom setting. While some data indicate the use of electronic devices in class can improve the classroom environment, other studies demonstrate the opposite finding. Moreover, it remains unclear if using social networking sites such as Instagram impacts performance on cognitive tasks when students are presented new material and, if so, what features of Instagram modulate this response. Therefore, in the current study we examined if social media use during or after being presented new information affected short-term memory in college students. Additionally, we assessed if the type or quantity of topics displayed had a modulatory impact on memory. Forty-five college-aged (18-24 years of age) students completed the Logical Memory Immediate Recall (LM I) component of the Wechsler Memory Scale IV, a measure of auditory recognition memory. Subjects were randomly divided into a group that completed the LM I without distraction (controls), a group that completed the LM I while scrolling through their Instagram feed, or a group that completed the LM I after scrolling through their Instagram feed. Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01). Recall ability in the group that used Instagram after hearing the story was not statistically different from the controls. Differences were not observed in the number of topics appearing in subjects' Instagram feeds and no correlation was found between the number of topics on a subject's Instagram feed and memory recall ability. Collectively, these results suggest that individuals who use their phones to browse Instagram during class or in social settings might have a reduced ability to retain the information given to them when compared to those that are not using their phones scrolling on social media.",2020,Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01).,"['Forty-five college-aged (18-24 years of age', 'college students', 'College Students']","['LM I without distraction (controls), a group that completed the LM I while scrolling through their Instagram feed, or a group that completed the LM']","['Logical Memory Immediate Recall (LM I) component of the Wechsler Memory Scale IV, a measure of auditory recognition memory', 'Recall ability', 'short-term memory recall ability']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.024727,Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01).,"[{'ForeName': 'Allyson', 'Initials': 'A', 'LastName': 'Spence', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Kierian', 'Initials': 'K', 'LastName': 'Beasley', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Gravenkemper', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hoefler', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ngo', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ortiz', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Campisi', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA. Electronic address: jcampisi@regis.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113172']
2852,32951241,"Pre-mixed nitrous oxide/oxygen mixture treatment of pain induced by postoperative dressing change for perianal abscess: Study protocol for a randomized, controlled trial.","AIM
This study aims to evaluate the safety and analgesic efficacy of pre-mixed nitrous oxide/oxygen mixture treatment of pain induced by dressing change for perianal abscess.
DESIGN
This protocol is a randomized, double-blind, placebo-controlled trial.
METHODS
This study will be implemented in the Hospital of Traditional Chinese Medicine. Subjects enrolled in this study are hospitalized patients who suffered from moderate to severe pain due to dressing change after incision and drainage. Two hundred patients will be selected and randomly assigned to either an intervention or a control group. The intervention group will get routine pain treatment plus pre-mixed nitrous oxide/oxygen mixture treatment and the control group will be treated with routine pain management plus medical air treatment. All these patients, medical staff and investigators are blind to the nature of the gas in each cylinder, which is randomized. Data will be collected at baseline (T0), 5 min (T1) after the starting of intervention and 5 min post intervention (T2) for each group. The primary outcome is the level of pain relief at T1 and T2. The secondary outcomes cover physiological parameters, adverse events, satisfaction of patients and health professionals and the acceptance from patients.
DISCUSSION
Results of this study will be discussed and the safety and effect of nitrous oxide/oxygen treatment of pain induced by dressing change will be proven.
IMPACT
When the finding of this study has an active effect on the treatment of pain caused by dressing change, it may provide more options for nursing staff to choose nurse-led analgesia techniques and then improving the level and quality of pain care as well as patients' overall satisfaction with the Anorectal Department in China.",2020,"Data will be collected at baseline (T0), 5 min (T1) after the starting of intervention and 5 min post intervention (T2) for each group.","['Two hundred patients', 'pain induced by postoperative dressing change for perianal abscess', 'hospitalized patients who suffered from moderate to severe pain due to dressing change after incision and drainage']","['pre-mixed nitrous oxide/oxygen mixture treatment', 'routine pain treatment plus pre-mixed nitrous oxide/oxygen mixture treatment and the control group will be treated with routine pain management plus medical air treatment', 'nitrous oxide/oxygen', 'placebo', 'Pre-mixed nitrous oxide/oxygen mixture treatment']","['safety and analgesic efficacy', 'level of pain relief at T1 and T2', 'physiological parameters, adverse events, satisfaction of patients and health professionals and the acceptance from patients']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0031019', 'cui_str': 'Perianal abscess'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0085671', 'cui_str': 'Change of dressing'}, {'cui': 'C0152277', 'cui_str': 'Incision AND drainage'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3536832', 'cui_str': 'Air'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",200.0,0.180767,"Data will be collected at baseline (T0), 5 min (T1) after the starting of intervention and 5 min post intervention (T2) for each group.","[{'ForeName': 'Jun-Jun', 'Initials': 'JJ', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Hai-Xiang', 'Initials': 'HX', 'LastName': 'Gao', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Wen-Qiang', 'Initials': 'WQ', 'LastName': 'Bao', 'Affiliation': 'Pain Department, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Jing-Yang', 'Initials': 'JY', 'LastName': 'Mou', 'Affiliation': 'TCM clinic of Puji Pharmacy, Yinchuan, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Meng', 'Affiliation': 'Anorectal Department, Yinchuan Hospital of Traditional Chinese Medicine affiliated to Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Ya-Liang', 'Initials': 'YL', 'LastName': 'Dai', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Gao', 'Affiliation': 'School of Public Health and Management, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'School of Basic Medical Sciences, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Zhi-Jing', 'Initials': 'ZJ', 'LastName': 'Li', 'Affiliation': 'Anorectal Department, Yinchuan Hospital of Traditional Chinese Medicine affiliated to Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Ge', 'Affiliation': 'Anorectal Department, Yinchuan Hospital of Traditional Chinese Medicine affiliated to Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Anorectal Department, Yinchuan Hospital of Traditional Chinese Medicine affiliated to Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Jian-Qiang', 'Initials': 'JQ', 'LastName': 'Yu', 'Affiliation': 'Department of Pharmacology, Pharmaceutical Institute of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Yu-Xiang', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}]",Journal of advanced nursing,['10.1111/jan.14515']
2853,32956964,Efficacy of learning through play plus intervention to reduce maternal depression in women with malnourished children: A randomized controlled trial from Pakistan ✰ .,"BACKGROUND
The risk factors and adverse outcomes related to maternal depression and child malnutrition are a leading cause of morbidity and mortality in low and middle-income countries (LMIC) including Pakistan. Above 25% of women suffer from maternal depression. Up to 50% children are under-nourished which contributes to 35% of all under-5 deaths in the country.
AIM
To determine the efficacy of Learning through Play Plus Thinking Healthy Program (LTP Plus) intervention to reduce maternal depression in mothers with undernourished children.
METHODS
In this randomised controlled trial, all eligible mothers presenting to the paediatric departments were invited to participate in the study. Out of the total 256 mothers screened, 107 were included, 54 of those were randomly allocated to LTP Plus group and 53 to treatment as usual (TAU). Edinburgh Postnatal Depression Scale (EPDS) was used to screen for depression. Hamilton Depression Rating Scale (HDRS), Maternal Attachment Inventory (MAI), Social Support Scale (OSLO-3) and the Euro-QoL (EQ-5D) were used to measure the severity of depression, mother-child attachment, level of support and health related quality of life dimensions. Assessments were completed at baseline, end of intervention (3 months from baseline) and at 6 months from baseline.
RESULTS
Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
CONCLUSION
The outcomes of LTP Plus intervention for mothers of malnourished children show promising results in reducing maternal depression and improving child outcomes. A full trial with longer-term outcomes and cost-effectiveness needs to be conducted.",2020,"RESULTS
Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
","['Out of the total 256 mothers screened, 107 were included, 54 of those', 'mothers with undernourished children', 'eligible mothers presenting to the paediatric departments were invited to participate in the study', 'mothers of malnourished children', 'women with malnourished children']","['Learning through Play Plus Thinking Healthy Program (LTP Plus) intervention', 'learning through play plus intervention', 'LTP Plus group and 53 to treatment as usual (TAU', 'LTP Plus intervention']","['Edinburgh Postnatal Depression Scale (EPDS', 'depression (p<0.001), social support', 'maternal depression', 'severity of depression, mother-child attachment, level of support and health related quality of life dimensions', 'maternal depression and improving child outcomes', 'quality of life', 'Hamilton Depression Rating Scale (HDRS), Maternal Attachment Inventory (MAI), Social Support Scale (OSLO-3) and the Euro-QoL (EQ-5D']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206249', 'cui_str': 'Long-Term Potentiation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1533125', 'cui_str': 'Euro'}]",,0.148806,"RESULTS
Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
","[{'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'University of Manchester United Kingdom; Lancashire Care NHS Foundation Trust. Electronic address: Nusrat.husain@manchester.ac.uk.'}, {'ForeName': 'Tayyeba', 'Initials': 'T', 'LastName': 'Kiran', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Lancashire Care NHS Foundation Trust; Pakistan Institute of Living and Learning.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'University of Liverpool United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Raza-Ur-Rehman', 'Affiliation': 'Dow University of Health Sciences.'}, {'ForeName': 'Qamar', 'Initials': 'Q', 'LastName': 'Saeed', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Shehla', 'Initials': 'S', 'LastName': 'Naeem', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Sami Ul', 'Initials': 'SU', 'LastName': 'Haq', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Farhat', 'Initials': 'F', 'LastName': 'Jaffery', 'Affiliation': 'Karachi Medical and Dental College Pakistan.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'University of Toronto.'}, {'ForeName': 'Farooq', 'Initials': 'F', 'LastName': 'Naeem', 'Affiliation': 'Centre for Addiction & Mental Health, Toronto, Canada.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Chaudhry', 'Affiliation': 'Pakistan Institute of Living and Learning.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.001']
2854,32957009,Meal skipping and cognition along a spectrum of restrictive eating.,"OBJECTIVE
Inadequate nutrition adversely impacts brain development and cognitive functioning (Pollitt et al., 1983). Studies examining the acute impact of eating regular meals on cognition have reported inconsistent findings, necessitating the exploration of individual differences in samples contributing to equivocal results. The present study examines the impact of skipping lunch on cognitive ability in college-aged students by including eating restraint as a moderator.
METHODS
Participants were 99 college-aged students (M = 19.7 years, SD = 1.5) randomized to a blinded 'lunch' or 'lunch-omission' condition, and assessed on memory, attention, processing speed, set shifting, and eating disorder symptomology.
RESULTS
Regressing long and short-term memory on the lunch manipulation, eating restraint scores, and their interaction revealed significant interactions: those who had lunch had superior memory performance, but only for those reporting lower levels of eating restraint. Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
CONCLUSIONS
Results suggest that skipping lunch may have immediate consequences on cognition, however, cognitive enhancing effects may be diminished in the presence of even low levels of eating restraint. Findings highlight the significance of purported subclinical levels of eating restraint and may inform health education strategies.",2020,"Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
","['college-aged students by including eating restraint as a moderator', 'Participants were 99 college-aged students (M\xa0=\xa019.7\xa0years, SD\xa0=\xa01.5) randomized to a']","['skipping lunch', ""blinded 'lunch' or 'lunch-omission' condition, and assessed on memory, attention, processing speed, set shifting""]","['cognitive ability', 'superior memory performance', 'lunch manipulation, eating restraint scores']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0492838,"Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
","[{'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Datta', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA. Electronic address: nandinid@stanford.edu.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Bidopia', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Datta', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Gaurie', 'Initials': 'G', 'LastName': 'Mittal', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Alphin', 'Affiliation': 'Duke University Department of Family Medicine and Community Health, Durham, NC, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Marsh', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Gavan J', 'Initials': 'GJ', 'LastName': 'Fitzsimons', 'Affiliation': 'Duke University Fuqua School of Business, Durham, NC, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Strauman', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Zucker', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA; Duke University School of Medicine Department of Psychiatry & Behavioral Sciences, Durham, NC, USA.'}]",Eating behaviors,['10.1016/j.eatbeh.2020.101431']
2855,32957034,Landing biomechanics are not immediately altered by a single-dose patellar tendon isometric exercise protocol in male athletes with patellar tendinopathy: A single-blinded randomized cross-over trial.,"OBJECTIVES
To a) determine the acute effects of a single-dose patellar tendon isometric exercise protocol on involved limb landing biomechanics in individuals with patellar tendinopathy and asymptomatic patellar tendon pathology, and b) determine if individuals with patellar tendinopathy demonstrated changes in pain following a single-dose patellar tendon isometric exercise protocol.
DESIGN
Single-blinded randomized cross-over trial.
SETTING
Laboratory; PARTICIPANTS: 28 young male athletes with symptomatic (n = 13, age: 19.62 ± 1.61) and asymptomatic (n = 15, age: 21.13 ± 1.88) patellar tendinopathy.
MAIN OUTCOME MEASURES
Participants completed a single-dose patellar tendon isometric exercise protocol and a sham-TENS protocol, randomized and separated by 7-10 days. Pain-levels during a single-limb decline squat (SLDS) and three-dimensional biomechanics were collected during a double-limb jump-landing task before and after each intervention protocol. A mixed-model repeated measures ANOVA was conducted to compare change scores for all dependent variables.
RESULTS
There were no group × intervention interactions for change in pain (F (1, 26) = 0.555, p = 0.463). There was one significant group × intervention interaction for vertical ground reaction force (VGRF) (F (1, 26) = 5.33, p = 0.029). However, post-hoc testing with Bonferroni correction demonstrated no statistical significance for group (SYM: t = -1.679, p = 0.119; ASYM: t = -1.7, p = 0.107) or intervention condition (isometric: t = -2.58, p = 0.016; sham-TENS: 0.72, p = 0.460). There were no further significant group × intervention interactions (p > 0.05).
CONCLUSIONS
A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.",2020,A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.,"['individuals with patellar tendinopathy and asymptomatic patellar tendon pathology, and b) determine if individuals with patellar tendinopathy', '28 young male athletes with symptomatic (n\xa0=\xa013, age: 19.62\xa0±\xa01.61) and asymptomatic (n\xa0=\xa015, age: 21.13\xa0±\xa01.88) patellar tendinopathy', 'male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology', 'male athletes with patellar tendinopathy']","['sham-TENS', 'single-dose patellar tendon isometric exercise protocol', 'single-limb decline squat (SLDS', 'single-dose patellar tendon isometric exercise protocol and a sham-TENS protocol', 'patellar tendon isometric exercise protocol']","['Pain-levels', 'landing biomechanics or pain levels', 'vertical ground reaction force (VGRF', 'limb landing biomechanics', 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191374', 'cui_str': '1.88'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",28.0,0.197403,A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.,"[{'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Pietrosimone', 'Affiliation': 'Doctor of Physical Therapy Division, Department of Orthopedic Surgery, School of Medicine, Duke University, Durham, NC, USA. Electronic address: laura.pietrosimone@duke.edu.'}, {'ForeName': 'J Troy', 'Initials': 'JT', 'LastName': 'Blackburn', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Wikstrom', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Berkoff', 'Affiliation': 'Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sean I', 'Initials': 'SI', 'LastName': 'Docking', 'Affiliation': 'La Trobe Sports and Exercise Research Centre, LaTrobe University, Bundooram, Australia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'La Trobe Sports and Exercise Research Centre, LaTrobe University, Bundooram, Australia.'}, {'ForeName': 'Darin A', 'Initials': 'DA', 'LastName': 'Padua', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.09.003']
2856,32960684,Re: Bipolar Vaporization of the Prostate May Cause Higher Complication Rates Compared to Bipolar Loop Resection: A Randomized Prospective Trial.,,2020,,[],['Bipolar Loop Resection'],[],[],"[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",[],,0.0361977,,"[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001268.02']
2857,32960716,Re: Effect of Water Composition and Timing of Ingestion on Urinary Lithogenic Profile in Healthy Volunteers: A Randomized Crossover Trial.,,2020,,['Healthy Volunteers'],['Water Composition and Timing of Ingestion'],['Urinary Lithogenic Profile'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]",[],,0.0487953,,"[{'ForeName': 'Dean G', 'Initials': 'DG', 'LastName': 'Assimos', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001280.01']
2858,32961410,Intranasal oxytocin and the stress-buffering effects of social support during experimentally induced pain: The role of attachment security.,"BACKGROUND
This study examined whether intranasal oxytocin enhances the stress-buffering effects of social support during experimentally induced pain, taking into account the role of individual differences in attachment security.
METHODS
Female participants (N = 193) were randomly assigned to oxytocin (24 IU intranasal) or placebo and to receive support or no support from a friend (2 × 2 factorial design with repeated measures)). Participants underwent the Cold Pressor Task (CPT) and were monitored for heart rate variability (HRV: RMSSD) and heart rate and reported pain levels. The Experiences in Close Relationships Questionnaire was used to measure attachment.
RESULTS
Oxytocin reduced RMSSD (p = 0.003, partial ɳ 2 = 0.03) and increased heart rate (p = 0.039, partial ɳ 2 = 0.03) in individuals who received support, possibly reflecting an enhanced attentional state. Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2 = 0.06).
LIMITATIONS
Only female participants were examined. Future studies are needed to determine sex differences in how oxytocin shapes stress-buffering effects of support.
CONCLUSIONS
Oxytocin may enhance the salience of social proximity and may be a mechanism underlying previously reported social influences on cardiovascular and mental health. However, oxytocin effects depend on interpersonal insecurities and may trigger discomfort in avoidantly attached individuals. Caution about oxytocin's therapeutic promise is warranted.",2020,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2 = 0.06).
","['Only female participants', 'Female participants (N\xa0=\xa0193']","['intranasal oxytocin', 'oxytocin', 'placebo and to receive support or no support from a friend', 'Oxytocin', 'Cold Pressor Task (CPT', 'Intranasal oxytocin']","['heart rate variability (HRV: RMSSD) and heart rate and reported pain levels', 'pain intensity', 'RMSSD', 'heart rate', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",193.0,0.159338,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2 = 0.06).
","[{'ForeName': 'M M E', 'Initials': 'MME', 'LastName': 'Riem', 'Affiliation': 'Behavioural Science Institute, Radboud University, The Netherlands; Department of Clinical Child and Family Studies, VU University, Amsterdam, The Netherlands. Electronic address: m.riem@psych.ru.nl.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Kunst', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands; Mentaal Beter, Breda, The Netherlands. Electronic address: L.E.Kunst@tilburguniversity.edu.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Kop', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands. Electronic address: W.J.Kop@tilburguniversity.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.057']
2859,32961445,"Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study.","OBJECTIVES
In the phase III CASPIAN study, first-line durvalumab plus etoposide in combination with either cisplatin or carboplatin (EP) significantly improved overall survival (primary endpoint) versus EP alone in patients with extensive-stage small-cell lung cancer (ES-SCLC) at the interim analysis. Here we report patient-reported outcomes (PROs).
MATERIALS AND METHODS
Treatment-naïve patients with ES-SCLC received 4 cycles of durvalumab plus EP every 3 weeks followed by maintenance durvalumab every 4 weeks until progression, or up to 6 cycles of EP every 3 weeks. PROs, assessed with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13), were prespecified secondary endpoints. Changes from baseline to disease progression or 12 months in prespecified key disease-related symptoms (cough, dyspnea, chest pain, fatigue, appetite loss) were analyzed with a mixed model for repeated measures. Time to deterioration (TTD) of symptoms, functioning, and global health status/quality of life (QoL) from randomization was analyzed.
RESULTS
In the durvalumab plus EP and EP arms, 261 and 260 patients were PRO-evaluable. Patients in both arms experienced numerically reduced symptom burden over 12 months or until progression for key symptoms. For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, -4.5; 99% CI: -9.04, -0.04; nominal p = 0.009). Patients experienced longer TTD with durvalumab plus EP versus EP for all symptoms (hazard ratio [95% CI] for key symptoms: cough 0.78 [0.600‒1.026]; dyspnea 0.79 [0.625‒1.006]; chest pain 0.76 [0.575‒0.996]; fatigue 0.82 [0.653‒1.027]; appetite loss 0.70 [0.542‒0.899]), functioning, and global health status/QoL.
CONCLUSION
Addition of durvalumab to first-line EP maintained QoL and delayed worsening of patient-reported symptoms, functioning, and global health status/QoL compared with EP.",2020,"For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, -4.5; 99% CI: -9.04, -0.04; nominal p = 0.009).","['Treatment-naïve patients with ES-SCLC received 4 cycles of', 'patients with extensive-stage small-cell lung cancer (ES-SCLC', 'extensive-stage small-cell lung cancer (CASPIAN']","['first-line durvalumab plus platinum-etoposide versus platinum-etoposide', 'cisplatin or carboplatin (EP', 'EP alone', 'durvalumab plus EP']","['appetite loss 0.70 [0.542‒0.899]), functioning, and global health status/QoL.\nCONCLUSION\n\n\nAddition of durvalumab to first-line EP maintained QoL and delayed worsening of patient-reported symptoms, functioning, and global health status/QoL', 'Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13', 'Cancer (EORTC', 'appetite loss', 'chest pain 0.76', 'symptom burden', 'symptoms (cough, dyspnea, chest pain, fatigue, appetite loss', 'overall survival', 'Time to deterioration (TTD) of symptoms, functioning, and global health status/quality of life (QoL']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.142705,"For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, -4.5; 99% CI: -9.04, -0.04; nominal p = 0.009).","[{'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Goldman', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: jwgoldman@mednet.ucla.edu.'}, {'ForeName': 'Marina Chiara', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Yuanbin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Cancer & Hematology Centers of Western Michigan, Grand Rapids, MI, USA.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Dvorkin', 'Affiliation': 'BHI of Omsk Region Clinical Oncology Dispensary, Omsk, Russia.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Trukhin', 'Affiliation': 'Odessa National Medical University, Odessa, Ukraine.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Statsenko', 'Affiliation': 'Omsk Regional Cancer Center, Omsk, Russian Federation.'}, {'ForeName': 'Katsuyuki', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Ji', 'Affiliation': 'Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.'}, {'ForeName': 'Maximilian J', 'Initials': 'MJ', 'LastName': 'Hochmair', 'Affiliation': 'Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Voitko', 'Affiliation': 'Kyiv City Clinical Oncological Centre, Kiev, Ukraine.'}, {'ForeName': 'Libor', 'Initials': 'L', 'LastName': 'Havel', 'Affiliation': 'Thomayer Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Artem', 'Initials': 'A', 'LastName': 'Poltoratskiy', 'Affiliation': 'Petrov Research Institute of Oncology, St Petersburg, Russian Federation.'}, {'ForeName': 'György', 'Initials': 'G', 'LastName': 'Losonczy', 'Affiliation': 'Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': 'Asklepios Lung Clinic, Munich-Gauting, Germany.'}, {'ForeName': 'Nikunj', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Laud', 'Affiliation': 'Statistical Services Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Norah', 'Initials': 'N', 'LastName': 'Shire', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Universidad Complutense and Ciberonc, Madrid, Spain.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.09.003']
2860,32976515,Short-term effect of a smartphone application on the mental health of university students: A pilot study using a user-centered design self-monitoring application for mental health.,"BACKGROUND
Despite the widespread recognition of the importance of mental health in young people, only a small proportion of young people with a mental disorder, including university students, receive mental health care.
OBJECTIVE
We developed a smartphone application (Mental App) for the university students and examined the effects of the app on their mental health.
METHODS
The app was designed according to a questionnaire survey conducted before this study. The Mental App was installed on the students' smartphone and the psychological tests (the Link Stigma Scale, the Center for Epidemiologic Studies Depression Scale, and the 12-item General Health Questionnaire) were performed on the same day. After using the App for two weeks, the students completed a questionnaire survey and underwent the same psychological tests. We compared the results between the app user and non-user group.
RESULTS
A total of 68 students participated, of which 57 students completed the study (app user group, n = 28; control group, n = 29). The mean number of days spent using the app was 5.66 ± 3.16 (mean ± SD). The mean total screen time of the app was 9:03 ± 06:41(min:sec). The mean number of total actions (screen taps or swipes) was 161.91 ± 107.34. There were no significant between-group differences in the ΔLink Stigma Scale score (-0.11 ± 4.28 vs. -0.59 ± 3.30, p = 0.496) or the ΔCenter for Epidemiologic Studies Depression Scale score (-4.39 ± 7.13 vs. -2.07 ± 8.78, p = 0.143). There was a significant between-group difference in the ΔGeneral Health Questionnaire score (-2.21± 2.23 vs. -0.17 ± 2.69, p = 0.007).
CONCLUSIONS
This non-randomized controlled pilot study indicates that the app we developed, may provide effective mental health care for university students, even in the short-term. Trial registration: UMIN000040332.",2020,The mean number of total actions (screen taps or swipes) was 161.91 ± 107.34.,"['68 students participated, of which 57 students completed the study (app user group, n = 28; control group, n = 29', 'mental health', 'university students', 'mental health of university students']","['smartphone application', 'smartphone application (Mental App']","['ΔGeneral Health Questionnaire score', 'Epidemiologic Studies Depression Scale score', 'mean total screen time', 'mean number of days spent', 'ΔLink Stigma Scale score', 'mean number of total actions (screen taps or swipes']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}]",68.0,0.0371091,The mean number of total actions (screen taps or swipes) was 161.91 ± 107.34.,"[{'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kajitani', 'Affiliation': 'Center for Health Sciences and Counseling, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Ikumi', 'Initials': 'I', 'LastName': 'Higashijima', 'Affiliation': 'Content and Creative Design Course, Department of Design, Graduate School of Design, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kaneko', 'Affiliation': 'Cybersecurity Center, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Matsushita', 'Affiliation': 'Center for Health Sciences and Counseling, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Fukumori', 'Affiliation': 'Center for Health Sciences and Counseling, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Daewoong', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Department of Content and Creative Design, Faculty of Design, Kyushu University, Fukuoka, Japan.'}]",PloS one,['10.1371/journal.pone.0239592']
2861,32976523,L-carnitine infusion does not alleviate lipid-induced insulin resistance and metabolic inflexibility.,"BACKGROUND
Low carnitine status may underlie the development of insulin resistance and metabolic inflexibility. Intravenous lipid infusion elevates plasma free fatty acid (FFA) concentration and is a model for simulating insulin resistance and metabolic inflexibility in healthy, insulin sensitive volunteers. Here, we hypothesized that co-infusion of L-carnitine may alleviate lipid-induced insulin resistance and metabolic inflexibility.
METHODS
In a randomized crossover trial, eight young healthy volunteers underwent hyperinsulinemic-euglycemic clamps (40mU/m2/min) with simultaneous infusion of saline (CON), Intralipid (20%, 90mL/h) (LIPID), or Intralipid (20%, 90mL/h) combined with L-carnitine infusion (28mg/kg) (LIPID+CAR). Ten volunteers were randomized for the intervention arms (CON, LIPID and LIPID+CAR), but two dropped-out during the study. Therefore, eight volunteers participated in all three intervention arms and were included for analysis.
RESULTS
L-carnitine infusion elevated plasma free carnitine availability and resulted in a more pronounced increase in plasma acetylcarnitine, short-, medium-, and long-chain acylcarnitines compared to lipid infusion, however no differences in skeletal muscle free carnitine or acetylcarnitine were found. Peripheral insulin sensitivity and metabolic flexibility were blunted upon lipid infusion compared to CON but L-carnitine infusion did not alleviate this.
CONCLUSION
Acute L-carnitine infusion could not alleviated lipid-induced insulin resistance and metabolic inflexibility and did not alter skeletal muscle carnitine availability. Possibly, lipid-induced insulin resistance may also have affected carnitine uptake and may have blunted the insulin-induced carnitine storage in muscle. Future studies are needed to investigate this.",2020,"Peripheral insulin sensitivity and metabolic flexibility were blunted upon lipid infusion compared to CON but L-carnitine infusion did not alleviate this.
","['eight volunteers participated in all three intervention arms and were included for analysis', 'eight young healthy volunteers', 'healthy, insulin sensitive volunteers', 'Ten volunteers']","['L-carnitine infusion', 'Intravenous lipid', 'L-carnitine', 'hyperinsulinemic-euglycemic clamps (40mU/m2/min) with simultaneous infusion of saline (CON), Intralipid (20%, 90mL/h) (LIPID), or Intralipid (20%, 90mL/h) combined with L-carnitine infusion (28mg/kg) (LIPID+CAR', 'intervention arms (CON, LIPID and LIPID+CAR']","['skeletal muscle carnitine availability', 'plasma acetylcarnitine, short-, medium-, and long-chain acylcarnitines', 'Peripheral insulin sensitivity and metabolic flexibility', 'skeletal muscle free carnitine or acetylcarnitine', 'lipid-induced insulin resistance and metabolic inflexibility']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0733854', 'cui_str': 'Intralipid'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0368608', 'cui_str': 'Acylcarnitine'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C4040379', 'cui_str': 'Free carnitine'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",8.0,0.0518461,"Peripheral insulin sensitivity and metabolic flexibility were blunted upon lipid infusion compared to CON but L-carnitine infusion did not alleviate this.
","[{'ForeName': 'Yvonne M H', 'Initials': 'YMH', 'LastName': 'Bruls', 'Affiliation': 'Departments of Radiology and Nuclear Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Yvo J M', 'Initials': 'YJM', 'LastName': 'Op den Kamp', 'Affiliation': 'Departments of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Phielix', 'Affiliation': 'Departments of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Lindeboom', 'Affiliation': 'Departments of Radiology and Nuclear Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Havekes', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Schaart', 'Affiliation': 'Departments of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Moonen-Kornips', 'Affiliation': 'Departments of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Joachim E', 'Initials': 'JE', 'LastName': 'Wildberger', 'Affiliation': 'Departments of Radiology and Nuclear Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Matthijs K C', 'Initials': 'MKC', 'LastName': 'Hesselink', 'Affiliation': 'Departments of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Departments of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Vera B', 'Initials': 'VB', 'LastName': 'Schrauwen-Hinderling', 'Affiliation': 'Departments of Radiology and Nuclear Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0239506']
2862,32944971,Group acceptance and commitment therapy for patients and caregivers in psychosis services: Feasibility of training and a preliminary randomized controlled evaluation.,"OBJECTIVE
Psychological interventions reduce the impact of psychosis, but widescale implementation is problematic. We tested the feasibility of group acceptance and commitment therapy for Psychosis (G-ACTp), delivered by frontline staff, and co-facilitated by service-user experts-by-experience (SU-EbyE), for service-users and informal caregivers (ISRCTN: 68540929). We estimated recruitment/retention rates and outcome variability for future evaluation.
METHODS
Staff and SU-EbyE facilitators completed 1-day workshops, then delivered closely supervised G-ACTp, comprising four sessions (weeks 1-4) and two boosters (10 and 12 weeks). Participants recruited from adult community psychosis services were randomized to receive G-ACTp immediately or after 12 weeks, completing outcome assessments at 0, 4, and 12 weeks. Service-use/month was calculated for 1-year pre-randomization, weeks 0-12, and 5-year uncontrolled follow-up.
RESULTS
Of 41 facilitators trained (29 staff, 12 SU-EbyE), 29 (71%; 17 staff, 12 SU-EbyE) delivered 18 G-ACTp courses. Participant refusal rates were low (9% of service-users [10/112]; 5% of caregivers [4/79]); 60% of those invited to participate attended ≥1 G-ACTp session (64% of service-users [39/61]; 56% of caregivers [35/63]). Randomization of facilitators and participants proved problematic and participant follow-up was incomplete (78% [66/85]; 82% of service-users [36/44]; 73% of caregivers [30/41]). Effect sizes ranged from very small to large mostly favouring treatment. Service-use reductions require cautious interpretation, as very few participants incurred costs.
CONCLUSIONS
Implementation appears feasible for service-users; for caregivers, retention needs improving. Outcome variability indicated n = 100-300/arm followed up (α = 0.05, 90% power). Methodological limitations' mean replication is needed: identified sources of potential bias may be reduced in a cluster randomized design with sessional outcome completion.
PRACTITIONER POINTS
Group acceptance and commitment therapy can be successfully adapted for people with psychosis and their caregivers. Implementation (training and delivery) is possible in routine community mental health care settings. Clinical and economic outcomes are promising, but replication is needed. Recommendations are made for future studies.",2020,Randomization of facilitators and participants proved problematic and participant follow-up was incomplete (78% [66/85]; 82% of service-users [36/44]; 73% of caregivers [30/41]).,"['people with psychosis and their caregivers', 'patients and caregivers in psychosis services', 'Participants recruited from adult community psychosis services']",['G-ACTp'],['Participant refusal rates'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}]",,0.209622,Randomization of facilitators and participants proved problematic and participant follow-up was incomplete (78% [66/85]; 82% of service-users [36/44]; 73% of caregivers [30/41]).,"[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Jolley', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Louise C', 'Initials': 'LC', 'LastName': 'Johns', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': ""O'Donoghue"", 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Oliver', 'Affiliation': 'University College London, UK.'}, {'ForeName': 'Mizanur', 'Initials': 'M', 'LastName': 'Khondoker', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Majella', 'Initials': 'M', 'LastName': 'Byrne', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Butler', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'De Rosa', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Leal', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McGovern', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Brigita', 'Initials': 'B', 'LastName': 'Rasiukeviciute', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Faye', 'Initials': 'F', 'LastName': 'Sim', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Morris', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}]",The British journal of clinical psychology,['10.1111/bjc.12265']
2863,32945898,"Insulin resistance induced by growth hormone is linked to lipolysis and associated with suppressed pyruvate dehydrogenase activity in skeletal muscle: a 2 × 2 factorial, randomised, crossover study in human individuals.","AIMS/HYPOTHESIS
Growth hormone (GH) causes insulin resistance that is linked to lipolysis, but the underlying mechanisms are unclear. We investigated if GH-induced insulin resistance in skeletal muscle involves accumulation of diacylglycerol (DAG) and ceramide as well as impaired insulin signalling, or substrate competition between fatty acids and glucose.
METHODS
Nine GH-deficient male participants were randomised and examined in a 2 × 2 factorial design with and without administration of GH and acipimox (an anti-lipolytic compound). As-treated analyses were performed, wherefore data from three visits from two patients were excluded due to incorrect GH administration. The primary outcome was insulin sensitivity, expressed as the AUC of the glucose infusion rate (GIR AUC ), and furthermore, the levels of DAGs and ceramides, insulin signalling and the activity of the active form of pyruvate dehydrogenase (PDHa) were assessed in skeletal muscle biopsies obtained in the basal state and during a hyperinsulinaemic-euglycaemic clamp (HEC).
RESULTS
Co-administration of acipimox completely suppressed the GH-induced elevation in serum levels of NEFA (GH versus GH+acipimox, p < 0.0001) and abrogated GH-induced insulin resistance (mean GIR AUC [95% CI] [mg min -1 kg -1 ] during the HEC: control, 595 [493, 718]; GH, 468 [382, 573]; GH+acipimox, 654 [539, 794]; acipimox, 754 [618, 921]; GH vs GH+acipimox: p = 0.004). GH did not significantly change either the accumulation of DAGs and ceramides or insulin signalling in skeletal muscle, but GH antagonised the insulin-stimulated increase in PDHa activity (mean ± SEM [% from the basal state to the HEC]: control, 47 ± 19; GH, -15 ± 21; GH+acipimox, 3 ± 21; acipimox, 57 ± 22; main effect: p = 0.02).
CONCLUSIONS/INTERPRETATION
GH-induced insulin resistance in skeletal muscle is: (1) causally linked to lipolysis; (2) not associated with either accumulation of DAGs and ceramides or impaired insulin signalling; (3) likely to involve substrate competition between glucose and lipid intermediates.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02782208 FUNDING: The work was supported by the Grant for Growth Innovation (GGI), which was funded by Merck KGaA, Darmstadt, Germany. Graphical abstract.",2020,"GH did not significantly change either the accumulation of DAGs and ceramides or insulin signalling in skeletal muscle, but GH antagonised the insulin-stimulated increase in PDHa activity (mean ± SEM [% from the basal state to the HEC]: control, 47 ± 19; GH, -15 ± 21; GH+acipimox, 3 ± 21; acipimox, 57 ± 22; main effect: p = 0.02).
","['human individuals', 'Nine GH-deficient male participants']","['acipimox', 'GH and acipimox']","['insulin sensitivity, expressed as the AUC of the glucose infusion rate (GIR AUC ), and furthermore, the levels of DAGs and ceramides, insulin signalling and the activity of the active form of pyruvate dehydrogenase (PDHa', 'abrogated GH-induced insulin resistance', 'accumulation of DAGs and ceramides or insulin signalling in skeletal muscle', 'GH-induced elevation in serum levels of NEFA', 'PDHa activity', 'skeletal muscle biopsies obtained in the basal state and during a hyperinsulinaemic-euglycaemic clamp (HEC']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0050558', 'cui_str': 'acipimox'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011967', 'cui_str': '1,2,5,6-Dianhydrogalactitol'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0072792', 'cui_str': 'Pyruvate dehydrogenase (lipoamide)'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C2315740', 'cui_str': 'Biopsy of skeletal muscle'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}]",,0.162835,"GH did not significantly change either the accumulation of DAGs and ceramides or insulin signalling in skeletal muscle, but GH antagonised the insulin-stimulated increase in PDHa activity (mean ± SEM [% from the basal state to the HEC]: control, 47 ± 19; GH, -15 ± 21; GH+acipimox, 3 ± 21; acipimox, 57 ± 22; main effect: p = 0.02).
","[{'ForeName': 'Astrid J', 'Initials': 'AJ', 'LastName': 'Hjelholt', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus N, Denmark. ajh@clin.au.dk.'}, {'ForeName': 'Evelina', 'Initials': 'E', 'LastName': 'Charidemou', 'Affiliation': 'Department of Biochemistry and Cambridge Systems Biology Centre, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Julian L', 'Initials': 'JL', 'LastName': 'Griffin', 'Affiliation': 'Department of Biochemistry and Cambridge Systems Biology Centre, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Steen B', 'Initials': 'SB', 'LastName': 'Pedersen', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Gudiksen', 'Affiliation': 'Section for Cell Biology and Physiology, Department of Biology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Pilegaard', 'Affiliation': 'Section for Cell Biology and Physiology, Department of Biology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'Department of Clinical Pharmacology, Aarhus University Hospital, Aarhus C, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Jens O L', 'Initials': 'JOL', 'LastName': 'Jørgensen', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus N, Denmark.'}]",Diabetologia,['10.1007/s00125-020-05262-w']
2864,32941528,Correction: Improved residual fat malabsorption and growth in children with cystic fibrosis treated with a novel oral structured lipid supplement: A randomized controlled trial.,[This corrects the article DOI: 10.1371/journal.pone.0232685.].,2020,[This corrects the article DOI: 10.1371/journal.pone.0232685.].,['children with cystic fibrosis treated with a'],['novel oral structured lipid supplement'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]",[],,0.032671,[This corrects the article DOI: 10.1371/journal.pone.0232685.].,"[{'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Stallings', 'Affiliation': ''}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Tindall', 'Affiliation': ''}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Mascarenhas', 'Affiliation': ''}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Maqbool', 'Affiliation': ''}, {'ForeName': 'Joan I', 'Initials': 'JI', 'LastName': 'Schall', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0239642']
2865,32942054,Design and baseline data of a randomized trial comparing two methods for scaling-up an occupational sun protection intervention.,"BACKGROUND
Successful methods for scaling-up evidence-based programs are needed to prevent skin cancer among adults who work outdoors in the sun.
METHODS
A randomized trial is being conducted comparing two methods of scaling-up the Sun Safe Workplaces (SSW) intervention. Departments of transportation (DOTs) from 21 U.S. states are participating and their 138 regional districts were randomized following baseline assessment. In districts assigned to the in-person method (n = 46), project staff meets personally with managers, conducts trainings for employees, and provides printed materials. In districts assigned to the digital method (n = 92), project staff conduct these same activities virtually, using conferencing technology, online training, and electronic materials. Delivery of SSW in both groups was tailored to managers' readiness to adopt occupational sun safety. Posttesting will assess manager's support for and use of SSW and employees' sun safety. An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
RESULTS
The state DOTs range in size from 997 to 18,415 employees. At baseline, 1113 managers (49.0%) completed the pretest (91.5% male, 91.1% white, 19.77 years on the job, 66.5% worked outdoors; and 24.4% had high-risk skin types). They were generally supportive of occupational sun safety. A minority reported that the employer had a written policy, half reported training, and two-thirds, messaging on sun protection.
CONCLUSIONS
Digital methods are available that may make scale-up of SSW cost-effective in a national distribution to nearly half of the state DOTs.
TRIAL REGISTRATION
The ClinicalTrials.gov registration number is NCT03278340.",2020,"An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
","['Departments of transportation (DOTs) from 21\u202fU.S. states are participating and their 138 regional districts', 'adults who work outdoors in the sun']","['scaling-up the Sun Safe Workplaces (SSW) intervention', 'scaling-up an occupational sun protection intervention']",[],"[{'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}]",[],,0.139656,"An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
","[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Research at Klein Buendel, Inc, A Health Communication and Media Development Firm, Golden, CO, USA. Electronic address: dbuller@kleinbuendel.com.'}, {'ForeName': 'Mary Klein', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': 'President at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meenan', 'Affiliation': 'Investigator at Kaiser Permanente Center for Health Research, Portland, OR, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Emeritus at the University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berteletti', 'Affiliation': 'Research Program Manager at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Eye', 'Affiliation': 'Project Coordinator at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Walkosz', 'Affiliation': 'Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Pagoto', 'Affiliation': 'University of Connecticut, Storrs, CT, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106147']
2866,32946885,Training primary care professionals in multimorbidity management: Educational assessment of the eMULTIPAP course.,"Multimorbidity (MM) is a widespread problem and it poses unsolved issues like the healthcare professionals' training. A training curriculum has been proposed, but it has not been sufficiently explored in a clinical context. The eMULTIPAP course is part of the MULTIPAP complex intervention, applied through a pragmatic controlled, cluster randomized clinical trial to general practitioners (GP) and his/her patients with MM with 12 months follow-up. The eMULTIPAP course is based on problem-based learning, constructivism and Ariadne principles. It has been assessed according to the Kirkpatrick model and has shown knowledge improvement and high applicability of learning with more motivation to consider MM in the clinical practice. It has also improved the Medication Appropriateness Index at 6-months and at 12- months. We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.",2020,"We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.",['general practitioners (GP) and his/her patients with MM with 12 months follow-up'],"['Multimorbidity (MM', 'eMULTIPAP']","['Medication Appropriateness Index', ""GP's learning""]","[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1535889', 'cui_str': 'Multimorbidity'}]","[{'cui': 'C4046084', 'cui_str': 'Medication Appropriateness Index'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.0184836,"We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.","[{'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Leiva-Fernández', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain. Electronic address: francisca.leiva.sspa@juntadeandalucia.es.'}, {'ForeName': 'Juan Daniel', 'Initials': 'JD', 'LastName': 'Prados-Torres', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain. Electronic address: juand.prados.sspa@juntadeandalucia.es.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Prados-Torres', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain. Electronic address: sprados.iacs@aragon.es.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Del-Cura-González', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit, Primary Health Care Management of Madrid, Madrid Health Service, Spain; Public Health and Preventive Medicine Area, University Rey Juan Carlos, Madrid, Spain. Electronic address: isabel.cura@salud.madrid.org.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Castillo-Jimena', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Primary Care Health Centre Coín, Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: marcosc.malaga@gmail.com.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'López-Rodríguez', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit, Primary Health Care Management of Madrid, Madrid Health Service, Spain; Public Health and Preventive Medicine Area, University Rey Juan Carlos, Madrid, Spain; Primary Care Health Centre General Ricardos, Madrid Health Service, Spain. Electronic address: juanantonio.lopez@salud.madrid.org.'}, {'ForeName': 'Maria Eloísa', 'Initials': 'ME', 'LastName': 'Rogero-Blanco', 'Affiliation': 'Primary Care Health Centre General Ricardos, Madrid Health Service, Spain. Electronic address: mariaeloisa.rogero@salud.madrid.org.'}, {'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Lozano-Hernández', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit, Primary Health Care Management of Madrid, Madrid Health Service, Spain. Electronic address: cristinamaria.lozano@salud.madrid.org.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'López-Verde', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Primary Care Health Centre Las Delicias, Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: flverde@gmail.com.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Bujalance-Zafra', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Primary Care Health Centre Victoria, Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: mjbujalance@hotmail.com.'}, {'ForeName': 'Maria Victoria', 'Initials': 'MV', 'LastName': 'Pico-Soler', 'Affiliation': 'EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain; Primary Care Health Centre Torrero-La Paz, Aragon Health Service, Zaragoza, Spain. Electronic address: vpico@salud.aragon.es.'}, {'ForeName': 'Luis Andrés', 'Initials': 'LA', 'LastName': 'Gimeno-Feliu', 'Affiliation': 'EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain; Primary Care Health Centre San Pablo. Aragon Health Service, Zaragoza, Spain. Electronic address: lugifel@gmail.com.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Poblador-Plou', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain. Electronic address: bpoblador.iacs@aragon.es.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Martinez-Cañavate', 'Affiliation': 'IAVANTE: Línea de Formación de la Fundación Progreso y Salud, Junta de Andalucía, Spain. Electronic address: teresa.martinezcanavate@juntadeandalucia.es.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Muth', 'Affiliation': 'Institute of General Practice, Johann Wolfgang Goethe University, Frankfurt, Germany. Electronic address: muth@allgemeinmedizin.uni-frankfurt.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Mechanisms of ageing and development,['10.1016/j.mad.2020.111354']
2867,32949780,Induction of LTD-like corticospinal plasticity by low-frequency rTMS depends on pre-stimulus phase of sensorimotor μ-rhythm.,"BACKGROUND
Neural oscillations reflect rapidly changing brain excitability states. We have demonstrated previously with EEG-triggered transcranial magnetic stimulation (TMS) of human motor cortex that the positive vs. negative peak of the sensorimotor μ-oscillation reflect corticospinal low-vs. high-excitability states. In vitro experiments showed that induction of long-term depression (LTD) by low-frequency stimulation depends on the postsynaptic excitability state.
OBJECTIVE/HYPOTHESIS
We tested the hypothesis that induction of LTD-like corticospinal plasticity in humans by 1 Hz repetitive TMS (rTMS) is enhanced when rTMS is synchronized with the low-excitability state, but decreased or even shifted towards long-term (LTP)-like plasticity when synchronized with the high-excitability state.
METHODS
We applied real-time EEG-triggered 1-Hz-rTMS (900 pulses) to the hand area of motor cortex in healthy subjects. In a randomized double-blind three-condition crossover design, pulses were synchronized to either the positive or negative peak of the sensorimotor μ-oscillation, or were applied at random phase (control). The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
RESULTS
1-Hz-rTMS at random phase resulted in a trend towards LTD-like corticospinal plasticity. RTMS in the positive peak condition (i.e., the low-excitability state) induced significant LTD-like plasticity. RTMS in the negative peak condition (i.e., the high-excitability state) showed a trend towards LTP-like plasticity, which was significantly different from the other two conditions.
CONCLUSION
The level of corticospinal depolarization reflected by phase of the μ-oscillation determines the degree of corticospinal plasticity induced by low-frequency rTMS, a finding that may guide future personalized therapeutic stimulation.",2020,"The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
",['healthy subjects'],"['Hz repetitive TMS (rTMS', '1-Hz-rTMS', 'EEG-triggered transcranial magnetic stimulation (TMS']","['amplitude of motor evoked potentials', 'induction of long-term depression (LTD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.095784,"The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baur', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Galevska', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, National Institutes of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Leonardo G', 'Initials': 'LG', 'LastName': 'Cohen', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, National Institutes of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Ziemann', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany. Electronic address: ulf.ziemann@uni-tuebingen.de.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zrenner', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}]",Brain stimulation,['10.1016/j.brs.2020.09.005']
2868,32950400,Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients.,"We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol-related negative behaviors and consequences, and 30-day treatment engagement. The trial design addresses the full spectrum of unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD). In an effort to surmount known ED-based alcohol screening, brief intervention, and referral to treatment process barriers, while addressing racial/ethnic alcohol-related health disparities among Latino groups, this trial will purposively use a digital health tool and seek enrollment of English and/or Spanish speaking self-identified adult Latino ED patients. Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish). The primary outcome will be the number of binge drinking days assessed using the 28-day timeline followback method at 12 months post-randomization. Secondary outcomes will include mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school. A sample size of 820 is necessary to provide 80% power to detect a 1.14 difference between AB-CASI and SC in the primary outcome. Showing efficacy of this promising bilingual ED-based brief intervention tool in Latino patients has the potential to widely and efficiently expand prevention efforts and facilitate meaningful contact with specialized treatment services.",2020,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","['Latino emergency department patients', 'English and/or Spanish speaking self-identified adult Latino ED patients', 'Latino patients', 'unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD']","['automated bilingual computerized alcohol screening and brief intervention (AB-CASI', 'bilingual digital health tool']","['mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school', 'number of binge drinking days assessed using the 28-day timeline followback method']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",,0.0627793,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","[{'ForeName': 'Federico E', 'Initials': 'FE', 'LastName': 'Vaca', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: federico.vaca@yale.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: james.dziura@yale.edu.'}, {'ForeName': 'Fuad', 'Initials': 'F', 'LastName': 'Abujarad', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: fuad.abujarad@yale.edu.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Pantalon', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: michael.pantalon@yale.edu.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Hsiao', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America; Yale School of Medicine, Department of Pediatrics, Section of Emergency Medicine, 100 York St, Suite 1F, New Haven, CT 06511, United States of America. Electronic address: allen.hsiao@yale.edu.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'University of Texas at El Paso, Latino Alcohol and Health Disparities Research Center (LAHDR), Psychology Building; Rooms 102 and 104, The University of Texas at El Paso, El Paso, TX 79968, United States of America. Electronic address: cfield@utep.edu.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': ""D'Onofrio"", 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: gail.donofrio@yale.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106128']
2869,32951337,Validation of the clinical applicability of knowledge-based planning models in single-isocenter volumetric-modulated arc therapy for multiple brain metastases.,"PURPOSE
To validate the clinical applicability of knowledge-based (KB) planning in single-isocenter volumetric-modulated arc therapy (VMAT) for multiple brain metastases using the k-fold cross-validation (CV) method.
METHODS
This study comprised 60 consecutive patients with multiple brain metastases treated with single-isocenter VMAT (28 Gy in five fractions). The patients were divided randomly into five groups (Groups 1-5). The data of Groups 1-4 were used as the training and validation dataset and those of Group 5 were used as the testing dataset. Four KB models were created from three of the training and validation datasets and then applied to the remaining Groups as the fourfold CV phase. As the testing phase, the final KB model was applied to Group 5 and the dose distributions were calculated with a single optimization process. The dose-volume indices (DVIs), modified Ian Paddick Conformity Index (mIPCI), modulation complexity scores for VMAT plans (MCSv), and the total number of monitor units (MUs) of the final KB plan were compared to those of the clinical plan (CL) using a paired Wilcoxon signed-rank test.
RESULTS
In the fourfold CV phase, no significant differences were observed in the DVIs among the four KB plans (KBPs). In the testing phase, the final KB plan was statistically equivalent to the CL, except for planning target volumes (PTVs) D 2% and D 50% . The differences between the CL and KBP in terms of the PTV D 99.5% , normal brain, and D max to all organs at risk (OARs) were not significant. The KBP achieved a lower total number of MUs and higher MCSv than the CL with no significant difference.
CONCLUSIONS
We demonstrated that a KB model in a single-isocenter VMAT for multiple brain metastases was equivalent in dose distribution, MCSv, and total number of MUs to a CL with a single optimization.",2020,"In the testing phase, the final KB plan was statistically equivalent to the CL, except for planning target volumes (PTVs)","['multiple brain metastases', '60 consecutive patients with multiple brain metastases treated with single-isocenter VMAT (28\xa0Gy in five fractions']",['knowledge-based (KB) planning in single-isocenter volumetric-modulated arc therapy (VMAT'],"['total number of MUs and higher MCSv', 'dose-volume indices (DVIs), modified Ian Paddick Conformity Index (mIPCI), modulation complexity scores for VMAT plans (MCSv), and the total number of monitor units (MUs) of the final KB plan', 'normal brain, and D max to all organs at risk (OARs', 'planning target volumes (PTVs']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0022752', 'cui_str': 'Knowledge Bases (Computer)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3489631', 'cui_str': 'Intensity-Modulated Arc Therapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0022752', 'cui_str': 'Knowledge Bases (Computer)'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C2936599', 'cui_str': 'Organs at Risk'}, {'cui': 'C0454199', 'cui_str': 'Planning target volume'}]",60.0,0.0117103,"In the testing phase, the final KB plan was statistically equivalent to the CL, except for planning target volumes (PTVs)","[{'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Kishi', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Hirashima', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Mukumoto', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Takehana', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Uto', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Matsuo', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Mizowaki', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]",Journal of applied clinical medical physics,['10.1002/acm2.13022']
2870,32960920,"Effects of passive, active, and mixed playing strategies on external and internal loads in female tennis players.","This study aimed to investigate the effects of different playing strategies on external and internal loads in female tennis players during match play. Also, the underlying effects on the technical-tactical actions and activity profiles were examined. Twelve well-trained female players (age: 25±5 years; maximum oxygen uptake: 40.9±4.3 ml/kg/min) played points against an opponent of similar ability outdoors on red-clay courts. The players played points over five playing conditions. Before each condition, the players were instructed to apply either a passive, an active, or their own playing strategy (free play) to succeed. The five conditions were played in a randomized order, whereas the condition with the own strategy was always played first and served as control. During play, the external and internal loads were investigated by 10 Hz global positioning system, 100 Hz inertial measurement unit, short-range telemetry, capillary blood, and visual analog scale procedures. A 25 Hz video camera was used to examine the technical-tactical actions and activity profiles. Compared to the control condition, the passive, active, and mixed playing strategy conditions induce up to large effects on the external loads (running distances with high acceleration and deceleration), up to moderate effects on the internal loads (energy expenditures spent with high metabolic power, lactate concentration, and rating of effort), and up to very large effects on the technical-tactical actions (number of ground strokes and errors) and activity profiles (strokes per rally, rally duration, work to rest ratio, and effective playing time). Our study shows that passive, active, and mixed playing strategies have an impact on the external and internal loads, technical-tactical actions, and activity profiles of female tennis players during match play. This finding should be considered for practical purposes like match analyses and training procedures in the tennis environment.",2020,"Compared to the control condition, the passive, active, and mixed playing strategy conditions induce up to large effects on the external loads (running distances with high acceleration and deceleration), up to moderate effects on the internal loads (energy expenditures spent with high metabolic power, lactate concentration, and rating of effort), and up to very large effects on the technical-tactical actions (number of ground strokes and errors) and activity profiles (strokes per rally, rally duration, work to rest ratio, and effective playing time).","['female tennis players', 'Twelve well-trained female players (age: 25±5 years; maximum oxygen uptake: 40.9±4.3 ml/kg/min) played points against an opponent of similar ability outdoors on red-clay courts', 'female tennis players during match play']","['passive, active, and mixed playing strategies']","['technical-tactical actions (number of ground strokes and errors) and activity profiles (strokes per rally, rally duration, work to rest ratio, and effective playing time', 'technical-tactical actions and activity profiles']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}]","[{'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0174105,"Compared to the control condition, the passive, active, and mixed playing strategy conditions induce up to large effects on the external loads (running distances with high acceleration and deceleration), up to moderate effects on the internal loads (energy expenditures spent with high metabolic power, lactate concentration, and rating of effort), and up to very large effects on the technical-tactical actions (number of ground strokes and errors) and activity profiles (strokes per rally, rally duration, work to rest ratio, and effective playing time).","[{'ForeName': 'Matthias W', 'Initials': 'MW', 'LastName': 'Hoppe', 'Affiliation': 'Institute of Movement and Training Science I, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hotfiel', 'Affiliation': 'Center for Musculoskeletal Surgery Osnabrück (OZMC), Klinikum Osnabrück, Osnabrück, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Stückradt', 'Affiliation': 'Department of Movement and Training Science, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Grim', 'Affiliation': 'Center for Musculoskeletal Surgery Osnabrück (OZMC), Klinikum Osnabrück, Osnabrück, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Ueberschär', 'Affiliation': 'Institute for Applied Training Science (IAT), Leipzig, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Freiwald', 'Affiliation': 'Department of Movement and Training Science, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Baumgart', 'Affiliation': 'Department of Movement and Training Science, University of Wuppertal, Wuppertal, Germany.'}]",PloS one,['10.1371/journal.pone.0239463']
2871,32962934,"Intraoperative Remifentanil Infusion and Postoperative Pain Outcomes After Cardiac Surgery-Results from Secondary Analysis of a Randomized, Open-Label Clinical Trial.","DESIGN
Report of secondary pain outcomes from a prospective, randomized, open-label clinical trial that compared remifentanil and fentanyl on perioperative hyperglycemic response in cardiac surgery.
SETTING
Single institution, tertiary university hospital.
PARTICIPANTS
The study comprised 116 adult elective cardiac surgical patients.
INTERVENTIONS
Participants were randomly assigned to receive either intermittent fentanyl boluses (F) or continuous remifentanil infusion (R) intraoperatively.
MEASUREMENTS AND MAIN RESULTS
Postoperative pain was evaluated with pain scores every 6 hours for 48 hours. Pain threshold to mechanical stimuli was measured around the sternotomy incision at 48 and 96 hours. The development of chronic pain was assessed using the numeric rating scale at 1, 3, 6, and 12 months after discharge. The final analysis included 106 patients. Pain scores and wound hyperalgesia were not significantly different postoperatively between the groups. The incidence of chronic pain at 3 months was comparable in both groups (61% in group F v 58% in group R; p = 0.79). Pain of more-than-mild degree was seen in 13 (32%) patients in group F and 8 (19%) in group R (p = 0.25) at 3 months. Median pain scores were not significantly different between the groups at 1, 3, 6, and 12 months after discharge from the hospital.
CONCLUSIONS
The present study's findings suggested that intraoperative remifentanil infusion does not significantly worsen pain outcomes in patients undergoing elective cardiac surgery.",2020,"Median pain scores were not significantly different between the groups at 1, 3, 6, and 12 months after discharge from the hospital.
","['cardiac surgery', '116 adult elective cardiac surgical patients', '106 patients', 'patients undergoing elective cardiac surgery', 'Single institution, tertiary university hospital']","['intraoperative remifentanil infusion', 'remifentanil and fentanyl', 'intermittent fentanyl boluses (F) or continuous remifentanil infusion (R) intraoperatively', 'Intraoperative Remifentanil']","['Pain scores and wound hyperalgesia', 'pain scores', 'chronic pain', 'numeric rating scale', 'pain outcomes', 'incidence of chronic pain', 'Pain', 'Median pain scores', 'perioperative hyperglycemic response', 'Pain threshold to mechanical stimuli', 'Postoperative Pain Outcomes']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",116.0,0.212556,"Median pain scores were not significantly different between the groups at 1, 3, 6, and 12 months after discharge from the hospital.
","[{'ForeName': 'Kathirvel', 'Initials': 'K', 'LastName': 'Subramaniam', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA. Electronic address: subramaniamk@upmc.edu.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ibarra', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Ruppert', 'Affiliation': 'Department of Epidemiology, Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Kushi', 'Initials': 'K', 'LastName': 'Mallikarjun', 'Affiliation': 'St Louis School of Medicine, Washington University, St Louis, MO.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Orebaugh', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.08.064']
2872,32969531,Return to training in the COVID-19 era: The physiological effects of face masks during exercise.,"COVID-19 outbreak has a profound impact on almost every aspect of life. Universal masking is recommended as a means of source control. Routinely exercising in a safe environment is an important strategy for healthy living during this crisis. As sports clubs and public spaces may serve a source of viral transmission, masking may become an integral part of physical activity. This study aimed to assess the physiological effects of wearing surgical masks and N95 respirators during short-term strenuous workout. This was a multiple cross-over trial of healthy volunteers. Using a standard cycle ergometry ramp protocol, each subject performed a maximal exercise test without a mask, with a surgical mask, and with an N95 respirator. Physiological parameters and time to exhaustion were compared. Each subject served his own control. Sixteen male volunteers (mean age and BMI of 34 ± 4 years and 28.72 ± 3.78 kg/m 2 , respectively) completed the protocol. Heart rate, respiratory rate, blood pressure, oxygen saturation, and time to exhaustion did not differ significantly. Exercising with N95 mask was associated with a significant increase in end-tidal carbon dioxide (EtCO 2 ) levels. The differences were more prominent as the load increased, reaching 8 mm Hg at exhaustion (none vs N95, P = .001). In conclusion, in healthy subjects, short-term moderate-strenuous aerobic physical activity with a mask is feasible, safe, and associated with only minor changes in physiological parameters, particularly a mild increase in EtCO 2 . Subjects suffering from lung diseases should have a cautious evaluation before attempting physical activity with any mask.",2020,"Heart rate, respiratory rate, blood pressure, oxygen saturation, and time to exhaustion did not differ significantly.","['healthy volunteers', 'healthy subjects', 'Sixteen male volunteers (mean age and BMI of 34 ±4 years and 28.72 ±3.78 kg/m2, respectively) completed the protocol', 'Subjects suffering from lung diseases', 'healthy living during this crisis']","['wearing surgical masks and N95 respirators', 'standard cycle ergometry ramp protocol, each subject performed a maximal exercise test without a mask, with a surgical mask, and with an N95 respirator']","['Physiological parameters and time to exhaustion', 'end-tidal carbon-dioxide (EtCO 2 ) levels', 'Heart rate, respiratory rate, blood pressure, oxygen saturation, and time to exhaustion']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}]","[{'cui': 'C0181758', 'cui_str': 'Surgical face mask'}, {'cui': 'C0429406', 'cui_str': 'Pattern ERG N95'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C1276408', 'cui_str': 'Ramp protocol'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",16.0,0.0239805,"Heart rate, respiratory rate, blood pressure, oxygen saturation, and time to exhaustion did not differ significantly.","[{'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Epstein', 'Affiliation': 'Internal Medicine ""B"" Department, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Korytny', 'Affiliation': 'Department of Gastroenterology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Yoni', 'Initials': 'Y', 'LastName': 'Isenberg', 'Affiliation': 'Internal Medicine ""B"" Department, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Erez', 'Initials': 'E', 'LastName': 'Marcusohn', 'Affiliation': 'Department of Cardiology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zukermann', 'Affiliation': 'Department of Cardiology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Bishop', 'Affiliation': 'Department of Nephrology, Rambam Medical Center, Haifa, Israel.'}, {'ForeName': ""Sa'ar"", 'Initials': 'S', 'LastName': 'Minha', 'Affiliation': 'Department of Cardiology, Shamir Medical Center, Zerifin, Israel.'}, {'ForeName': 'Aeyal', 'Initials': 'A', 'LastName': 'Raz', 'Affiliation': 'Department of Anesthesiology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Asaf', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'Medical Intensive Care unit, Rambam Health Care Campus, Haifa, Israel.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13832']
2873,32966105,Donor Cell Fate in Particulated Juvenile Allograft Cartilage for the Repair of Articular Cartilage Defects.,"BACKGROUND
Particulated juvenile allograft cartilage (PJAC) has demonstrated good clinical efficacy in repairing articular cartilage defects, but the related repair mechanism after transplant and the biological characteristics of the transplanted cells are still unclear.
PURPOSE
To study the efficacy of PJAC in repairing full-thickness cartilage defects and the specific fate of donor cells to provide experimental evidence for its clinical application.
STUDY DESIGN
Controlled laboratory study.
METHODS
Twenty female Guizhou minipigs were randomly divided into an experimental group and a control group. An 8-mm cylindrical full-thickness cartilage defect was created in the femoral trochlea of 1 knee in all minipigs. The experimental group received transplant of PJAC from 5 male juvenile Guizhou minipigs (PJAC group; n = 10) and the control group received autologous cartilage chips (ACC group; n = 10). Follow-up assessments were conducted at 1 month and 3 months to track the transplanted cells by the male-specific sex-determining region Y-linked (SRY) gene; tissue sections were hybridized in situ, and O'Driscoll histological scoring was performed according to hematoxylin and eosin staining, safranin O and fast green staining, and toluidine blue O staining, as well as immunohistochemical evaluation of aggrecan and Sry-type HMG-box 9 (SOX9).
RESULTS
All 20 Guizhou minipigs were followed; no infection or incision healing disorder occurred after the operation. By SRY in situ hybridization, the SRY signal of the transplanted cells was positive in the repaired tissue of the defect, and the SRY positive signal could still be detected in repaired tissue at 3 months postoperatively. The average number of positive cells was 68.6 ± 11.91 at 1 month and 32.6 ± 3.03 at 3 months (confocal microscope: ×400), and the difference was statistically significant. The O'Driscoll histological scores were 14 ± 0.71 in the ACC group and 9.8 ± 0.84 in the PJAC group at 1 month, and 18 ± 1.20 in the ACC group and 17.4 ± 1.14 in the PJAC group at 3 months. The scores were statistically significant between the ACC group and PJAC group at 1 month. The positive rates of SOX9 in the PJAC and ACC groups at 1 month were 67.6% ± 3.78% and 63.4% ± 5.30%, respectively, and the difference was not statistically significant ( P > .05). The positive rates of SOX9 in the PJAC and ACC groups at 3 months were 68.8% ± 2.69% and 17.1% ± 1.26%, respectively, and the difference was statistically significant ( P < .05). The positive rates of aggrecan in the PJAC and ACC groups at 1 month were 40.5% ± 2.78% and 42.4% ± 0.54% respectively, and the difference was not statistically significant ( P > .05). The positive rates of aggrecan in the PJAC and ACC groups at 3 months were 40.8% ± 1.50% and 30.1% ± 2.44%, respectively, and the difference was not statistically significant ( P > .05).
CONCLUSION
An animal model was established with Guizhou minipigs, and the cartilage defect was repaired with PJAC from male minipigs. The SRY gene positive signal could be detected from the repaired tissue by in situ hybridization, indicating that the transplanted cells survived at least 3 months. The key genes of cartilage formation, SOX9 and aggrecan, were expressed at 1 month and 3 months, and SOX9 expression was stronger in the PJAC group than the ACC group at 3 months.
CLINICAL RELEVANCE
This study suggests that it is feasible to study the biological characteristics of transplanted cells in the cartilage region by the sex-determining gene.",2020,"The key genes of cartilage formation, SOX9 and aggrecan, were expressed at 1 month and 3 months, and SOX9 expression was stronger in the PJAC group than the ACC group at 3 months.
","['Twenty female Guizhou minipigs', 'from 5 male juvenile Guizhou minipigs (PJAC group; n = 10) and the']","['PJAC', 'Particulated juvenile allograft cartilage (PJAC', 'control group received autologous cartilage chips (ACC', 'transplant of PJAC']","[""O'Driscoll histological scores"", 'infection or incision healing disorder', 'cartilage formation, SOX9 and aggrecan', 'positive rates of SOX9', 'positive rates of aggrecan', 'SOX9 expression', 'average number of positive cells']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039011', 'cui_str': 'Miniature Swine'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0598067', 'cui_str': 'Cartilage formation'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025326', 'cui_str': 'human menopausal gonadotrophin'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0081487', 'cui_str': 'Aggrecan'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}]",5.0,0.0335541,"The key genes of cartilage formation, SOX9 and aggrecan, were expressed at 1 month and 3 months, and SOX9 expression was stronger in the PJAC group than the ACC group at 3 months.
","[{'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Yunong', 'Initials': 'Y', 'LastName': 'Ao', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Duan', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}]",The American journal of sports medicine,['10.1177/0363546520958700']
2874,32966123,Effects of L-type voltage-gated Ca 2+ channel blockade on cholinergic and thermal sweating in habitually trained and untrained men.,"We evaluated the hypothesis that the activation of L-type voltage-gated Ca 2+ channels contributes to exercise training-induced augmentation in cholinergic sweating. On separate days, 10 habitually trained and 10 untrained men participated in two experimental protocols. Prior to each protocol, we administered 1% verapamil (Verapamil, L-type voltage-gated Ca 2+ channel blocker) and saline (Control) at forearm skin sites on both arms via transdermal iontophoresis. In protocol 1 , we administered low (0.001%) and high (1%) doses of pilocarpine at both the verapamil-treated and verapamil-untreated forearm sites. In protocol 2 , participants were passively heated by immersing their limbs in hot water (43°C) until rectal temperature increased by 1.0°C above baseline resting levels. Sweat rate at all forearm sites was continuously measured throughout both protocols. Pilocarpine-induced sweating in Control was higher in trained than in untrained men for both the concentrations of pilocarpine (both P ≤ 0.001). Pilocarpine-induced sweating at the low-dose site was attenuated at the Verapamil versus the Control site in both the groups (both P ≤ 0.004), albeit the reduction was greater in trained as compared with in untrained men ( P = 0.005). The verapamil-mediated reduction in sweating remained intact at the high-dose pilocarpine site in the untrained men ( P = 0.004) but not the trained men ( P = 0.180). Sweating did not differ between Control and Verapamil sites with increases in rectal temperature in both groups (interaction, P = 0.571). We show that activation of L-type voltage-gated Ca 2+ channels modulates sweat production in habitually trained men induced by a low dose of pilocarpine. However, no effect on sweating was observed during passive heating in either group.",2020,Pilocarpine-induced sweating in Control was higher in trained than in untrained men for both concentrations of pilocarpine (both P≤0.001).,"['habitually trained men', '10 habitually trained and 10 untrained men participated in two experimental protocols', 'habitually trained and untrained men']","['verapamil-treated and untreated forearm sites', 'Pilocarpine', 'verapamil (Verapamil, L-type voltage-gated Ca 2+ channel blocker) and saline (Control', 'L-type voltage-gated Ca 2+ channel blockade', 'Verapamil', 'pilocarpine', 'verapamil']","['sweating in Control', 'sweating', 'rectal temperature', 'Sweating', 'cholinergic and thermal sweating', 'Sweat rate']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0031923', 'cui_str': 'Pilocarpine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0596235', 'cui_str': 'Calcium ion'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0242893', 'cui_str': 'Acetylcholine Agents'}]",,0.0322647,Pilocarpine-induced sweating in Control was higher in trained than in untrained men for both concentrations of pilocarpine (both P≤0.001).,"[{'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Amano', 'Affiliation': 'Laboratory for Exercise and Environmental Physiology, Faculty of Education, Niigata University, Niigata, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Fujii', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba City, Japan.'}, {'ForeName': 'Glen P', 'Initials': 'GP', 'LastName': 'Kenny', 'Affiliation': 'Human and Environmental Physiology Research Unit, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Laboratory for Exercise and Environmental Physiology, Faculty of Education, Niigata University, Niigata, Japan.'}, {'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Laboratory for Human Performance Research, Osaka International University, Osaka, Japan.'}, {'ForeName': 'Narihiko', 'Initials': 'N', 'LastName': 'Kondo', 'Affiliation': 'Laboratory for Applied Human Physiology, Graduate School of Human Development and Environment, Kobe University, Kobe, Japan.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00167.2020']
2875,32971040,Effects of once-weekly subcutaneous semaglutide on kidney function and safety in patients with type 2 diabetes: a post-hoc analysis of the SUSTAIN 1-7 randomised controlled trials.,"BACKGROUND
Patients with type 2 diabetes have a high risk of developing chronic kidney disease. We examined the effects of semaglutide on kidney function and safety in a large, broad type 2 diabetes population.
METHODS
We did a post-hoc analysis of 8416 patients with type 2 diabetes enrolled in the SUSTAIN 1-5 and SUSTAIN 7 randomised controlled trials, and the SUSTAIN 6 cardiovascular outcomes trial, to examine the effects of once-weekly subcutaneous semaglutide 0·5 mg and 1·0 mg versus comparators (active treatments or placebo) on estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), and kidney adverse events. Data from SUSTAIN 1-5 and SUSTAIN 7 were pooled. eGFR and UACR were also analysed by kidney function and albuminuria status.
FINDINGS
In SUSTAIN 1-5 and SUSTAIN 7, eGFR decreased from baseline to week 12 with all active treatments; estimated treatment differences (ETDs) versus placebo were -2·15 (95% CI -3·47 to -0·83) mL/min per 1·73 m 2 with semaglutide 0·5 mg and -3·00 (-4·31 to -1·68) mL/min per 1·73 m 2 with semaglutide 1·0 mg; after week 12, eGFR plateaued. In SUSTAIN 1-5 and SUSTAIN 7, from baseline to end of treatment the decline in eGFR was greater with semaglutide than with placebo (ETD -1·58 [95% CI -2·92 to -0·25] mL/min per 1·73 m 2 with semaglutide 0·5 mg and -2·02 [-3·35 to -0·68] mL/min per 1·73 m 2 with semaglutide 1·0 mg). In SUSTAIN 6, the decline in eGFR was greater with semaglutide than with placebo from baseline to week 16 (ETD -1·29 [95% CI -2·07 to -0·51] mL/min per 1·73 m 2 with semaglutide 0·5 mg and -1·56 [-2·33 to -0·78] mL/min per 1·73 m 2 with semaglutide 1·0 mg), but not from week 16 to week 104 (1·29 [0·30 to 2·28] mL/min per 1·73 m 2 with semaglutide 0·5 mg and 2·44 [1·45 to 3·44] mL/min per 1·73 m 2 with semaglutide 1·0 mg). Overall (ie, from baseline to week 104), the eGFR decline in SUSTAIN 6 was similar between semaglutide and placebo (ETD 0·07 [95% CI -0·92 to 1·07] mL/min per 1·73 m 2 with semaglutide 0·5 mg and 0·97 [-0·03 to 1·97] mL/min per 1·73 m 2 with semaglutide 1·0 mg). In SUSTAIN 1-5, UACR ratios at end of treatment to baseline were 0·917 with semaglutide 0·5 mg, 0·836 with semaglutide 1·0 mg, and 1·239 with placebo; at end of treatment, greater reductions in UACR were observed with semaglutide versus placebo (estimated treatment ratios 0·74 [95% CI 0·64 to 0·85] for semaglutide 0·5 mg and 0·68 [0·59 to 0·78] for semaglutide 1·0 mg). In SUSTAIN 6, UACR ratios at end of treatment (week 104) to baseline were 0·973 with semaglutide 0·5 mg, 0·858 with semaglutide 1·0 mg, and 1·302 with placebo; at week 104, greater reductions in UACR were observed with semaglutide versus placebo (estimated treatment ratios 0·75 [95% CI 0·66 to 0·85] for semaglutide 0·5 mg and 0·66 [0·58 to 0·75] for semaglutide 1·0 mg). In SUSTAIN 1-7, eGFR initially declined in patients with normal kidney function (and in those with mild kidney impairment with semaglutide 1·0 mg in SUSTAIN 6), but overall (ie, by week 30 for SUSTAIN 1-5 and SUSTAIN 7, and week 104 for SUSTAIN 6), eGFR did not differ between semaglutide and placebo. In SUSTAIN 1-6, UACR decreased in patients with pre-existing microalbuminuria or macroalbuminuria at baseline; it did not change or increased in those with normoalbuminuria at baseline. Kidney adverse events were balanced between treatment groups.
INTERPRETATION
Across the SUSTAIN 1-7 trials, semaglutide was associated with initial reductions in eGFR that plateaued, and marked reductions in UACR. This post-hoc analysis suggests no increase in the risk of kidney adverse events with semaglutide versus the active comparators used across SUSTAIN 1-7.
FUNDING
Novo Nordisk.",2020,"In SUSTAIN 1-5 and SUSTAIN 7, from baseline to end of treatment the decline in eGFR was greater with semaglutide than with placebo (ETD -1·58","['Patients with type 2 diabetes', 'patients with type 2 diabetes', '8416 patients with type 2 diabetes enrolled in the SUSTAIN 1-5']","['semaglutide', '0·5 mg and -3·00 ', '0·25', 'once-weekly subcutaneous semaglutide 0·5', 'once-weekly subcutaneous semaglutide', 'placebo (ETD -1·58', '4·31 to -1·68', '1·56', ' mL/min per 1·73 m 2 with semaglutide 0·5', 'placebo', 'semaglutide 0·5 mg and -2·02', '0·51] mL/min per 1·73 m 2 with semaglutide 0·5', '2·33 to -0·78', 'mg and 1·0 mg versus comparators (active treatments or placebo']","['eGFR and UACR', 'kidney function and albuminuria status', 'decline in eGFR', 'UACR ratios', 'kidney function and safety', 'eGFR decline', 'UACR', 'eGFR', 'risk of kidney adverse events', 'Kidney adverse events', 'estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), and kidney adverse events', 'normal kidney function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]","[{'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]",8416.0,0.16795,"In SUSTAIN 1-5 and SUSTAIN 7, from baseline to end of treatment the decline in eGFR was greater with semaglutide than with placebo (ETD -1·58","[{'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Center, Munich, Germany; Friedrich Alexander University of Erlangen-Nürnberg, Erlangen, Germany. Electronic address: johannes.mann@kms.mhn.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Idorn', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Marso', 'Affiliation': 'HCA Midwest Heart and Vascular Institute, Overland Park, Overland Park, KS, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Seufert', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Medicine II, Medical Center -Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Sayeh', 'Initials': 'S', 'LastName': 'Tadayon', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, University of Copenhagen, Hellerup, Denmark.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30313-2']
2876,32978540,What are the effects of verbal and written information on pain perception in orthodontic patients?,"Design Randomised controlled trial.Study population Sixty patients aged 10-18 years requiring fixed orthodontic treatment were randomly allocated to the study or control group. Anxiety levels and somatosensory amplification were evaluated. All patients received general verbal instructions on orthodontic treatment (dietary habits, oral hygiene maintenance and pain). Patients in the study group also received written information (a take-home leaflet) on orthodontic pain characteristics and management. Patients, clinicians and statistician were blinded to the patient allocation.Outcome measure The primary outcome was the pain intensity and the secondary outcome was analgesic consumption.Data analysis Multilevel regression analysis of variance (ANOVA) for repeated measures with split plot design.Results Pain perception and analgesic consumption were significantly higher in the control group only during the first two days after appliance placement (P <0.05).Conclusions Combining verbal and written information diminished pain perception and analgesic consumption in orthodontic patients in the first days after appliance placement.",2020,Results Pain perception and analgesic consumption were significantly higher in the control group only during the first two days after appliance placement (P <0.05).Conclusions,"['Study population Sixty patients aged 10-18 years requiring fixed orthodontic treatment', 'orthodontic patients', 'orthodontic patients in the first days after appliance placement']","['general verbal instructions', 'written information (a take-home leaflet']","['Pain perception and analgesic consumption', 'analgesic consumption', 'pain intensity', 'Anxiety levels and somatosensory amplification', 'pain perception and analgesic consumption', 'pain perception']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",60.0,0.189931,Results Pain perception and analgesic consumption were significantly higher in the control group only during the first two days after appliance placement (P <0.05).Conclusions,"[{'ForeName': 'Paulo Antônio', 'Initials': 'PA', 'LastName': 'Martins-Júnior', 'Affiliation': 'Department of Child and Adolescent Oral Health, Faculty of Dentistry, Federal University of Minas Gerais, Brazil.'}]",Evidence-based dentistry,['10.1038/s41432-020-0124-4']
2877,32979235,Time to relapse after tildrakizumab withdrawal in patients with moderate-to-severe psoriasis who were responders at week 28: post hoc analysis through 64 weeks from reSURFACE 1 trial.,"BACKGROUND
As treatment interruptions occur during psoriasis management in clinical practice, it is important to know the duration of clinical response after treatment withdrawal.
OBJECTIVES
To report time to and predictors of relapse in patients who were tildrakizumab 100 and 200 mg responders (≥75% improvement in Psoriasis Area and Severity Index, PASI 75) at week 28 re-randomized to placebo from reSURFACE 1 trial.
METHODS
Post hoc analysis of adult patients with moderate-to-severe plaque psoriasis from a 64-week phase 3 trial. Relapse was primarily defined as loss of PASI 75 response. Both relapses defined as loss of PASI 90 and loss of absolute PASI < 2 response were included as sensitivity analyses. PASI 75, PASI 90 and PASI < 2 responders re-randomized to placebo at week 28 and followed up until week 64 were included. The Kaplan-Meier (KM) estimates of the 64-week relapse rate were calculated. The log-rank test to compare KM curves from responders to tildrakizumab 100 and 200 mg was used. Independent predictors of relapse were explored.
RESULTS
Median time to loss of PASI 75/PASI 90/PASI < 2 response from week 28 was 142/111/112 days with tildrakizumab 100 mg and 172/140/113 days with tildrakizumab 200 mg, respectively (all not significant). Around 20% of patients did not relapse (either maintained a PASI 75 response or were lost to follow-up) during the 36-week period. Increase in body mass index (BMI) (hazard ratio, HR [95% confidence interval, CI] for loss of PASI 75 response: 1.0345 [1.0112-1.0582]) and increase in disease duration (HR [95% CI]: 1.0151 [1.0028-1.0275] for loss of PASI 75 response) were associated with an increased risk of relapse, regardless of the relapse definition.
CONCLUSIONS
When treatment is interrupted, tildrakizumab provides durable maintenance of efficacy with a median time to loss of PASI 75 response of 5-6 months, irrespective of the dose. Interventions on modifiable risk factors for relapse, such as BMI, may improve personalized long-term psoriasis management.",2020,Around 20% of patients did not relapse (either maintained a PASI 75 response or were lost to follow-up) during the 36-week period.,"['adult patients with moderate-to-severe plaque psoriasis from a 64-week phase 3 trial', 'patients who were tildrakizumab 100 and 200 mg responders (≥75% improvement in Psoriasis Area and Severity Index; PASI 75) at week 28 re-randomized to', 'patients with moderate-to-severe psoriasis']","['placebo', 'tildrakizumab']","['disease duration', 'Kaplan-Meier (KM) estimates of the 64-week relapse rate', 'body mass index (BMI) (hazard ratio, HR', 'risk of relapse, regardless of the relapse definition', 'Relapse', 'Median time to loss of PASI 75/PASI 90/PASI']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4043954', 'cui_str': 'tildrakizumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4043954', 'cui_str': 'tildrakizumab'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.124221,Around 20% of patients did not relapse (either maintained a PASI 75 response or were lost to follow-up) during the 36-week period.,"[{'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Carrascosa', 'Affiliation': 'Department of Dermatology, Germans Trias i Pujol University Hospital (HUGTP), Autonomous University of Barcelona (UAB), Badalona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fumero', 'Affiliation': 'Almirall R&D, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schoenenberger', 'Affiliation': 'Almirall R&D, Barcelona, Spain.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Szepietowski', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, Skinflammation® Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16964']
2878,32979249,COVID-19: Comparing the applicability of shared room and single room occupancy.,"To curb the COVID-19 pandemic, isolation measures are required. Shared room occupancy is recommended when isolation rooms are insufficient. However, there is little evidence of the applicability of shared and single room occupancy for patients with COVID-19 to determine whether shared room occupancy is feasible. COVID-19-infected patients admitted to the Daegu Dongsan Hospital of Keimyung University from 21 February 2020 to 20 April 2020 were enrolled in the study and randomly assigned to hospital rooms. Clinical symptoms, underlying diseases and epidemiological data of patients were analysed after dividing participants into a shared room occupancy group (group A) and a single room occupancy group (group B). Outcomes analysed included microbiological cure rates, time to clinical symptom improvement, time to defervescence and negative-to-positive conversion rates of polymerase chain reaction (PCR) results during hospitalization. A total of 666 patients were included in this study, 535 and 131 patients in groups A and B, respectively. Group B included more underlying conditions, such as pregnancy and solid organ transplantation, and was more closely associated with severe pneumonia during hospitalization. Besides, no statistically significant differences between the two groups in terms of negative PCR rates at HD 7 and 14, conversion rates of PCR results from negative-to-positive, as well as time to the improvement of clinical symptoms, and time to defervescence were observed. Our results suggest that the shared room occupancy of patients with mild symptoms could be an alternative to single room occupancy during the COVID-19 pandemic.",2020,"Besides, no statistically significant differences between the two groups in terms of negative PCR rates at HD 7 and 14, conversion rates of PCR results from negative-to-positive, as well as time to the improvement of clinical symptoms, and time to defervescence were observed.","['COVID-19 patients admitted to the Daegu Dongsan Hospital of Keimyung University from 21 st February 2020 to 20 th April 2020 were enrolled in the study and randomly assigned to hospital rooms', 'A total of 666 patients were included in this study, 535 and 131 patients in groups A and B, respectively']",['COVID-19'],"['clinical symptoms, and time to defervescence', 'negative PCR rates', 'microbiological cure rates, time to clinical symptom improvement, time to defervescence, and negative-to-positive conversion rates of polymerase chain reaction (PCR) results during hospitalization']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",666.0,0.034077,"Besides, no statistically significant differences between the two groups in terms of negative PCR rates at HD 7 and 14, conversion rates of PCR results from negative-to-positive, as well as time to the improvement of clinical symptoms, and time to defervescence were observed.","[{'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Hyun', 'Affiliation': 'Division of Infectious Diseases, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Division of Infectious Diseases, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Yong Shik', 'Initials': 'YS', 'LastName': 'Kwon', 'Affiliation': 'Division of Pulmonology, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Division of Radiology, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Jae Seok', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonology, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Sunggyun', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Division of Laboratory Medicine, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Namhee', 'Initials': 'N', 'LastName': 'Ryoo', 'Affiliation': 'Division of Laboratory Medicine, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Hyun Ah', 'Initials': 'HA', 'LastName': 'Kim', 'Affiliation': 'Division of Infectious Diseases, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}]",Transboundary and emerging diseases,['10.1111/tbed.13853']
2879,32979577,"Cerebrospinal fluid biomarkers of brain injury, inflammation and synaptic autoimmunity predict long-term neurocognitive outcome in herpes simplex encephalitis.","OBJECTIVES
The aim was to investigate the correlation between biomarkers of brain injury and long-term neurocognitive outcome, and the interplay with intrathecal inflammation and neuronal autoimmunity, in patients with herpes simplex encephalitis (HSE).
METHODS
A total of 53 adult/adolescent HSE patients were included from a prospective cohort in a randomized placebo-controlled trial investigating the effect of a 3-month follow-up treatment with valaciclovir. Study subjects underwent repeated serum/cerebrospinal fluid (CSF) sampling and brain magnetic resonance imaging in the first 3 months along with cognitive assessment using the Mattis Dementia Rating Scale (MDRS) at 24 months. CSF samples were analysed for biomarkers of brain injury, inflammation and synaptic autoimmunity. The predefined primary analysis was the correlation between peak CSF neurofilament protein (NFL), a biomarker of neuronal damage, and MDRS at 24 months.
RESULTS
Impaired cognitive performance significantly correlated with NFL levels (rho = -0.36, p = 0.020). Development of IgG anti-N-methyl-D-aspartate receptor (NDMAR) antibodies was associated with a broad and prolonged proinflammatory CSF response. In a linear regression model, lower MDRS at 24 months was associated with previous development of IgG anti-N-methyl-D-aspartate receptor (NMDAR) (beta = -0.6249, p = 0.024) and age (z-score beta = -0.2784, p = 0.024), but not CSF NFL, which however significantly correlated with subsequent NMDAR autoimmunization (p = 0.006).
DISCUSSION
Our findings show that NFL levels are predictive of long-term neurocognitive outcome in HSE, and suggest a causative chain of events where brain tissue damage increases the risk of NMDAR autoimmunisation and subsequent prolongation of CSF inflammation. The data provides guidance for a future intervention study of immunosuppressive therapy administered in the recovery phase of HSE.",2020,"RESULTS
Impaired cognitive performance significantly correlated with NFL levels (rho = -0.36, p = 0.020).","['patients with herpes simplex encephalitis (HSE', 'herpes simplex encephalitis', 'A total of 53 adult/adolescent HSE patients']","['placebo', 'immunosuppressive therapy', 'IgG anti-N-methyl-D-aspartate receptor (NDMAR) antibodies', 'valaciclovir']","['NFL levels', 'peak CSF neurofilament protein (NFL), a biomarker of neuronal damage, and MDRS', 'subsequent NMDAR autoimmunization', 'Mattis Dementia Rating Scale (MDRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0014038', 'cui_str': 'Encephalitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0051979', 'cui_str': 'Anti-Immunoglobulin G antibody'}, {'cui': 'C2919931', 'cui_str': 'N-methyl-D-aspartate receptor antibody'}, {'cui': 'C0249458', 'cui_str': 'valacyclovir'}]","[{'cui': 'C0085418', 'cui_str': 'Neurofilament protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0451074', 'cui_str': 'Clinical dementia rating scale'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}]",53.0,0.106535,"RESULTS
Impaired cognitive performance significantly correlated with NFL levels (rho = -0.36, p = 0.020).","[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Westman', 'Affiliation': 'Department of Medical Sciences, Section of Infectious Diseases, Uppsala University, Uppsala, Sweden. Electronic address: gabriel.westman@medsci.uu.se.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Aurelius', 'Affiliation': 'Unit of Infectious Diseases, Department of Medicine, Karolinska Institutet, Department of Infectious Diseases, Karolinska University Hospital, Solna, Sweden.'}, {'ForeName': 'Clas', 'Initials': 'C', 'LastName': 'Ahlm', 'Affiliation': 'Department of Clinical Microbiology, Infection and Immunology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Blennow', 'Affiliation': 'Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden; Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Eriksson', 'Affiliation': 'Department of Rheumatology and Inflammation Research, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Lind', 'Affiliation': 'Department of Rheumatology and Inflammation Research, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Schliamser', 'Affiliation': 'Department of Clinical Sciences, Division of Infection Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Sund', 'Affiliation': 'Department of Medical Sciences, Section of Infectious Diseases, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterberg', 'Affiliation': 'Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden; Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden; Department of Neurodegenerative Disease, UCL Institute of Neurology, London, United Kingdom; UK Dementia Research Institute at UCL, London, United Kingdom.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Studahl', 'Affiliation': 'Institute of Biomedicine, The Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden; Department of Infectious Diseases, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.09.031']
2880,32979429,Long-term tDCS effects on neurophysiological measures of cognitive control in tobacco smokers.,"INTRODUCTION
In this study we assessed the effects of transcranial Direct Current Stimulation (tDCS) on inhibitory control and error processing as measures of cognitive control to better understand tDCS modulation of smoking behaviour.
METHODS
Smokers were allocated to six sessions of either active tDCS (n = 34) or sham tDCS (n = 35) (https://clinicaltrials.gov/ct2/show/NCT03027687). Immediately before, one day after, and three months after all tDCS sessions, participants performed the Go-NoGo task while we measured behavioural and neurophysiological responses.
RESULTS
One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers. However, a significant improvement in reaction times, and a decrease in No-Go P3 amplitudes for smoking cues was found three months after active tDCS.
CONCLUSION
Given the direction of the effect, we speculate that tDCS has a long-term modulatory learning effect on selective attention and motor inhibition.",2020,One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers.,"['tobacco smokers', 'Smokers']","['sham tDCS', 'transcranial Direct Current Stimulation (tDCS', 'tDCS', 'active tDCS']","['No-Go P3 amplitudes for smoking cues', 'reaction times', 'behavioural and neurophysiological measures of cognitive control']","[{'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0365492,One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers.,"[{'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Verveer', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands. Electronic address: verveer@essb.eur.nl.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Remmerswaal', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Frederik M', 'Initials': 'FM', 'LastName': 'van der Veen', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Ingmar H A', 'Initials': 'IHA', 'LastName': 'Franken', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107962']
2881,32949954,A randomized control trial of meditation compared to music listening to improve cognitive function for breast cancer survivors: Feasibility and acceptability.,"BACKGROUND
and Purpose: Many breast cancer survivors (BCS) experience persistent cognitive and psychological changes associated with their cancer and/or treatment and that have limited treatment options. Therefore, the purpose of this study was to explore the feasibility and effects of a Kirtan Kriya meditation (KK) intervention on cognitive and psychological symptoms compared to an attention control condition, classical music listening (ML), in BCS.
MATERIALS AND METHODS
A randomized control trial design was used. Participants completed eight-week interventions. Cognitive function and psychological symptoms were measured at baseline and post-intervention. Mixed analysis of variance models were examined for all cognitive and psychological outcomes.
RESULTS
27 BCS completed the study. Intervention adherence was 88%. Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's < 0.01). There were no significant group by time effects for cognitive and psychological outcomes, except stress. The ML group reported lower stress at time 2 (p < 0.05).
CONCLUSION
KK and ML are feasible, acceptable, and cost-effective interventions that may be beneficial for survivors' cognition and psychological symptoms. Both interventions were easy to learn, low cost, and required just 12 min/day. Meditation or music listening could offer providers evidence-based suggestions to BCS experiencing cognitive symptoms.
CLINICAL TRIALS REGISTRATION NUMBER
NCT03696056.",2020,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ",['breast cancer survivors'],"['Meditation or music listening', 'music listening', 'classical music listening (ML', 'Kirtan Kriya meditation (KK) intervention', 'meditation']","['cognitive and psychological symptoms', 'time effects for cognitive and psychological outcomes, except stress', ""perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's"", 'cognitive function', 'Cognitive function and psychological symptoms', 'Intervention adherence']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.062006,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Henneghan', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Oncology, 1601 Trinity St, Austin, TX, 78712, USA. Electronic address: ahenneghan@utexas.edu.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Harrison', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Inselmann', 'Affiliation': 'Cancer Rehab and Integrative Medicine, 4130 Spicewood Springs Rd. Ste. 100, Austin, TX, 78759, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Fico', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Schafer', 'Affiliation': 'The University of Texas at Austin, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Division of Clinical Cancer Genomics City of Hope, 1500 E. Duarte Road, Duarte, CA, 91010, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Patt', 'Affiliation': 'Texas Oncology, The University of Texas at Austin, Department of Oncology, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Kesler', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Diagnostic Medicine, 1601 Trinity St, Austin, TX, 78712, USA.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101228']
2882,32954927,"Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE).","PURPOSE
Many patients with HR+, HER2- early breast cancer (EBC) will not experience recurrence or have distant recurrence with currently available standard therapies. However, up to 30% of patients with high-risk clinical and/or pathologic features may experience distant recurrence, many in the first few years. Superior treatment options are needed to prevent early recurrence and development of metastases for this group of patients. Abemaciclib is an oral, continuously dosed, CDK4/6 inhibitor approved for HR+, HER2- advanced breast cancer (ABC). Efficacy and safety of abemaciclib in ABC supported evaluation in the adjuvant setting.
METHODS
This open-label, phase III study included patients with HR+, HER2-, high-risk EBC, who had surgery and, as indicated, radiotherapy and/or adjuvant/neoadjuvant chemotherapy. Patients with four or more positive nodes, or one to three nodes and either tumor size ≥ 5 cm, histologic grade 3, or central Ki-67 ≥ 20%, were eligible and randomly assigned (1:1) to standard-of-care adjuvant endocrine therapy (ET) with or without abemaciclib (150 mg twice daily for 2 years). The primary end point was invasive disease-free survival (IDFS), and secondary end points included distant relapse-free survival, overall survival, and safety.
RESULTS
At a preplanned efficacy interim analysis, among 5,637 randomly assigned patients, 323 IDFS events were observed in the intent-to-treat population. Abemaciclib plus ET demonstrated superior IDFS versus ET alone ( P = .01; hazard ratio, 0.75; 95% CI, 0.60 to 0.93), with 2-year IDFS rates of 92.2% versus 88.7%, respectively. Safety data were consistent with the known safety profile of abemaciclib.
CONCLUSION
Abemaciclib when combined with ET is the first CDK4/6 inhibitor to demonstrate a significant improvement in IDFS in patients with HR+, HER2- node-positive EBC at high risk of early recurrence.",2020,"Abemaciclib plus ET demonstrated superior IDFS versus ET alone ( P = .01; hazard ratio, 0.75; 95% CI, 0.60 to 0.93), with 2-year IDFS rates of 92.2% versus 88.7%, respectively.","['patients with HR+, HER2-, high-risk EBC, who had surgery and, as indicated', 'Patients with four or more positive nodes, or one to three\u202fnodes and either tumor size ≥ 5 cm, histologic grade 3, or central Ki-67 ≥ 20', 'patients with HR+, HER2- early breast cancer (EBC']","['CDK4/6 inhibitor', 'Abemaciclib Combined With Endocrine Therapy', 'standard-of-care adjuvant endocrine therapy (ET) with or without abemaciclib', 'radiotherapy and/or adjuvant/neoadjuvant chemotherapy']","['invasive disease-free survival (IDFS), and secondary end points included distant relapse-free survival, overall survival, and safety', 'Efficacy and safety', '2-year IDFS rates', 'IDFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0919553', 'cui_str': 'Histologic grade'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}]",5637.0,0.075697,"Abemaciclib plus ET demonstrated superior IDFS versus ET alone ( P = .01; hazard ratio, 0.75; 95% CI, 0.60 to 0.93), with 2-year IDFS rates of 92.2% versus 88.7%, respectively.","[{'ForeName': 'Stephen R D', 'Initials': 'SRD', 'LastName': 'Johnston', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Department of Obstetrics and Gynecology, Breast Center, LMU University Hospital, Munich, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'Clinica Pesquisas e Centro São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Universidad Complutense, Ciberonc, GEICAM, Madrid, Spain.'}, {'ForeName': 'Zhi Min', 'Initials': 'ZM', 'LastName': 'Shao', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Qing Yuan', 'Initials': 'QY', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Jorge Luis', 'Initials': 'JL', 'LastName': 'Martinez Rodriguez', 'Affiliation': 'Alivia Clinica de Alta Especialidad, Nuevo Leon, Mexico.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Institut de Cancérologie de l'Ouest Pays de la Loire, Saint Herblain-Angers, France.""}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Hamilton', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei Cancer Center, Seoul, Korea.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Guarneri', 'Affiliation': 'Department of Surgery, Oncology, and Gastroenterology, University of Padova, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy.'}, {'ForeName': 'Morihito', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Boyle', 'Affiliation': 'Mater Hospital Sydney, Patricia Ritchie Centre for Cancer Care and Research, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Universitaire Ziekenhuizen Leuven-Campus Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': ""IOB Institute of Oncology, Quiron Group, Madrid, Barcelona, and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Breast Center, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wardley', 'Affiliation': 'NIHR Manchester Clinical Research Facility at The Christie, and Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Cicin', 'Affiliation': 'Trakya University Faculty of Medicine, Edirne, Turkey.'}, {'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Smith', 'Affiliation': 'Artios Pharma, Cambridge, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Frenzel', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Headley', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Wei', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'San Antonio', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Hulstijn', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cox', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'University of Pittsburgh, NSABP Foundation, Pittsburgh, PA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02514']
2883,32955801,"Hydroxychloroquine for prophylaxis of COVID-19 physicians survey: Despite lack of evidence, many would take or give to dear ones, and despite the perceived necessity of an RCT, few would participate.","INTRODUCTION
There was no evidence concerning the prophylaxis with hydroxychloroquine, and only low-grade evidence regarding the use of hydroxychloroquine as a treatment for COVID-19 patients. We performed a survey among Romanian physicians in order to see how many of them would administer prophylactically hydroxychloroquine to themselves or to people close to them, and if they would participate to a randomized controlled trial.
METHODS
Between March 30 and April 02, 2020, a 16-item questionnaire was shared in a Romanian Facebook group of 2645 physicians dedicated to COVID-19 information, asking to be completed by physicians who could be directly involved in the care of these patients.
RESULTS
A total of 785 answers were collected. Nine physicians (1.1%) thought that there was clear evidence on prescribing hydroxychloroquine prophylaxis, 375 (48%) considered the evidence acceptable, 348 (44.3%) considered it weak, whereas 53 (6.8%) answered there was no evidence. 59 (7.5%) respondents were determined to take it (of which 31 = 4% already took), 192 (24.5%) were inclined to take, 271 (34.5%) were not decided yet. 175 (22.3%) of respondents declared they (would) give the treatment to their close ones, and this decision was associated with a higher age (P = 0.003), and the opinion that there was evidence (P < 0.001). When asked about the source of the treatment regimen, 286 (36.4%) indicated a scientific paper, while no scientific paper about the prophylaxis with hydroxychloroquine existed at that time. 718 (91.5%) considered a randomized clinical trial necessary (RCT), but only 333 (42.4%) answered they would enrol in such a trial. There was only a very weak correlation (Kendall's tau _b = 0.255, P < 0.001) between the belief that an RCT is necessary and the willingness to enrol in such an RCT.
CONCLUSIONS
Despite the lack of evidence, many physicians considered the evidence as existing, and were ready to take or to give hydroxychloroquine prophylactically to family. They considered an RCT necessary, but they were not willing to participate.",2020,"There was only a very weak correlation (Kendall's tau _b = 0.255, P < 0.001) between the belief that an RCT is necessary and the willingness to enrol in such an RCT","['Between March 30 and April 02, 2020, a 16-item questionnaire was shared in a Romanian Facebook group of 2645 physicians dedicated to COVID-19 information, asking to be completed by physicians who could be directly involved in the care of these patients', 'COVID-19 patients']","['RCT', 'hydroxychloroquine', 'Hydroxychloroquine']",[],"[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035827', 'cui_str': 'Rumanian language'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],785.0,0.0736841,"There was only a very weak correlation (Kendall's tau _b = 0.255, P < 0.001) between the belief that an RCT is necessary and the willingness to enrol in such an RCT","[{'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Baicus', 'Affiliation': 'Department of Internal Medicine, Colentina Hospital, Bucharest, Romania.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Pinte', 'Affiliation': 'Department of Internal Medicine, Colentina Hospital, Bucharest, Romania.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Stoichitoiu', 'Affiliation': 'Department of Internal Medicine, Colentina Hospital, Bucharest, Romania.'}, {'ForeName': 'Camelia', 'Initials': 'C', 'LastName': 'Badea', 'Affiliation': 'Department of Internal Medicine, Colentina Hospital, Bucharest, Romania.'}]",Journal of evaluation in clinical practice,['10.1111/jep.13484']
2884,32950853,Supporting coordination of children with ASD using neurological music therapy: A pilot randomized control trial comparing an elastic touch-display with tambourines.,"AIM
To evaluate the efficacy of Neurologic Music Therapy (NMT) using a traditional and a technological intervention (elastic touch-display) in improving the coordination of children with Autism Spectrum Disorder (ASD), as a primary outcome, and the timing and strength control of their movements as secondary outcomes.
METHODS
Twenty-two children with ASD completed 8 NMT sessions, as a part of a 2-month intervention. Participants were randomly assigned to either use an elastic touch-display (experimental group) or tambourines (control group). We conducted pre- and post- assessment evaluations, including the Developmental Coordination Disorder Questionnaire (DCDQ) and motor assessments related to the control of strength and timing of movements.
OUTCOMES AND RESULTS
All participants improved their coordination, according to the DCDQ scores, and exhibited better control of their movements according to the strength and timing assessments after the intervention. Participants who used the elastic touch-display scored higher on the DCDQ.
CONCLUSIONS AND IMPLICATIONS
NMT is an efficacious treatment to improve the coordination skills of children with ASD. Elastic touch-displays provide more benefits than the use of tambourines.",2020,"All participants improved their coordination, according to the DCDQ scores, and exhibited better control of their movements according to the strength and timing assessments after the intervention.","['children with Autism Spectrum Disorder (ASD', 'children with ASD', 'Twenty-two children with ASD completed 8 NMT sessions, as a part of a 2-month intervention', 'Participants who used the elastic touch-display scored higher on the DCDQ']","['Neurologic Music Therapy (NMT', 'elastic touch-display (experimental group) or tambourines (control group', 'technological intervention (elastic touch-display', 'neurological music therapy', 'elastic touch-display with tambourines']",['Developmental Coordination Disorder Questionnaire (DCDQ) and motor assessments related to the control of strength and timing of movements'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011757', 'cui_str': 'Developmental coordination disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",22.0,0.0293978,"All participants improved their coordination, according to the DCDQ scores, and exhibited better control of their movements according to the strength and timing assessments after the intervention.","[{'ForeName': 'Franceli L', 'Initials': 'FL', 'LastName': 'Cibrian', 'Affiliation': 'Fowler School of Engineering, Chapman University, Orange California, USA. Electronic address: cibrian@chapman.edu.'}, {'ForeName': 'Melisa', 'Initials': 'M', 'LastName': 'Madrigal', 'Affiliation': 'CETYS Universidad, Tijuana, Mexico. Electronic address: melisa.madrigal@cetys.edu.mx.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Avelais', 'Affiliation': 'CETYS Universidad, Tijuana, Mexico. Electronic address: marina.alvelais@cetys.mx.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Tentori', 'Affiliation': 'Computer Science Department, Center for Scientific Research and Higher Education of Ensenada (CICESE), Mexico. Electronic address: mtentori@cicese.mx.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103741']
2885,32950920,The effect of marker size on three-dimensional motion analysis of the foot.,"BACKGROUND
In the field of three-dimensional motion analysis of the foot, there is little agreement on the preferred size of markers to record kinematic parameters. Although currently applied marker sizes show a considerable range, there has been no detailed investigation of the effect of marker size on the calculation of foot kinematics in the current literature.
RESEARCH QUESTION
The objective of this research was to determine whether marker size impacts essential parameters that describe foot biomechanics.
METHODS
Seventeen subjects participated in this randomized repeatability study. All participants had to walk on a treadmill twice to test two sets of markers (set A: small marker, 9.5 mm, 1 g; set B: large marker, 14 mm, 2 g). Three-dimensional motion capturing was used to record the trajectories of the markers. The spatial relation of the markers, as well as vertical motion of the navicular bone and the angle of the medial longitudinal arch were calculated based on the marker trajectories. In addition to motion capturing, skin rigidity was quantified by applying an oscillatory shear force to the skin. Analysis of variance, root-mean-square error calculations and linear fit methods were applied to evaluate effects of marker size on the calculation of foot kinematics and the impact of skin rigidity.
RESULTS
The estimated foot kinematics appeared to be unaffected by the size of the markers. Further, there was no evidence that skin rigidity influenced the error of the marker trajectories. Interestingly, the large markers fell off more frequently.
SIGNIFICANCE
The findings will be of interest to those who use marker-based three-dimensional motion capturing, especially to analyze foot biomechanics. Although the calculation of kinematic parameters appears to be unaffected by marker size, practical aspects, like accidental marker loss, favor the application of small markers.",2020,The estimated foot kinematics appeared to be unaffected by the size of the markers.,['Seventeen subjects participated'],[],"['estimated foot kinematics', 'skin rigidity']","[{'cui': 'C0450331', 'cui_str': '17'}]",[],"[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}]",17.0,0.0404244,The estimated foot kinematics appeared to be unaffected by the size of the markers.,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Ebrecht', 'Affiliation': 'Department of Human Locomotion, Chemnitz University of Technology, Straße der Nationen 62, 09111 Chemnitz, Germany. Electronic address: florian.ebrecht@hsw.tu-chemnitz.de.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Sichting', 'Affiliation': 'Department of Human Locomotion, Chemnitz University of Technology, Straße der Nationen 62, 09111 Chemnitz, Germany.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.007']
2886,32956682,"A feasibility study of application and potential effects of a single session transcranial direct current stimulation (tDCS) on competitive anxiety, mood state, salivary levels of cortisol and alpha amylase in elite athletes under a real-world competition.","OBJECTIVE
To examine feasibility and potential effects of a single session tDCS over the dorsolateral prefrontal cortex (DLPFC) on competitive anxiety, mood state, and autonomic and endocrine stress responses in elite archer athletes under a real world competition.
METHODS
Twelve male elite archers volunteered to participate in this pilot trial. Participants were randomized in order to take left anodal DLPFC, left cathodal DLPFC, or sham stimulation (the F3 or F4 areas according to the 10/20 EEG International System) in a within-subject study design. This study included three official competitions. About 45 min before the competition, the tDCS stimulation process was started and the participants were stimulated for 20 min with 2 mA current. Psychophysiological responses, including Brunel Mood Scale and Competitive state anxiety inventory-2-revied, were collected 15 min before each competition. Additionally, salivary cortisol (sCort) and salivary alpha-amylase (sAA) were collected 1 hour and 10 min before competition as well as 10 min and 1 hour after competition.
RESULTS
Findings demonstrated that anodal tDCS was feasible and could lead to enhance mood state (vigor, tension and fatigue) and a decrease in competitive anxiety, as compared to cathodal and sham stimulation (all p < 0.05). However, self-confidence remained unaffected by the tDCS (p > 0.05). Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05). Correlations between competitive anxiety and mood states with physiological stress markers (sCort and sAA) were not significant (all p > 0.05).
CONCLUSIONS
The present study provides the first preliminary evidence that anodal tDCS over the DLPFC is feasible and could modulate competitive anxiety and physiological stress responses to the acute stress of competition (potentially by a top-down regulation of HPA and SAM systems as well as the vagal system). Findings support the notion that non-invasive brain stimulation might be advantageous to enhance sport performance under competitive situations. However, additional studies in a larger sample size and different sport activities are encouraged to substantiate the findings.",2020,Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05).,"['elite athletes under a real-world competition', 'elite archer athletes under a real world competition', 'Twelve male elite archers volunteered to participate in this pilot trial']","['anodal tDCS', 'single session transcranial Direct Current Stimulation (tDCS', 'left anodal DLPFC, left cathodal DLPFC, or sham stimulation (the F3 or F4 areas according to the 10/20 EEG International System', 'single session tDCS']","['lower salivary cortisol and alpha-amylase response', 'competitive anxiety and mood states with physiological stress markers (sCort and sAA', 'competitive anxiety, mood state, salivary levels of cortisol and alpha amylase', 'competitive anxiety', 'competitive anxiety, mood state, and autonomic and endocrine stress responses', 'Psychophysiological responses, including Brunel Mood Scale and Competitive State Anxiety inventory-2-Revied', 'salivary cortisol (sCort) and salivary alpha-amylase (sAA', 'enhance mood state (vigor, tension and fatigue']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",12.0,0.0310646,Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05).,"[{'ForeName': 'Amir Hossien', 'Initials': 'AH', 'LastName': 'Mehrsafar', 'Affiliation': 'Department of Sport Psychology, Faculty of Sport Sciences, University of Tehran, Tehran, Iran. Electronic address: a.mehrsafar@ut.ac.ir.'}, {'ForeName': 'Miguel Angel Serrano', 'Initials': 'MAS', 'LastName': 'Rosa', 'Affiliation': 'Department of Psychobiology, Faculty of Psychology, University of Valencia, Valencia, Spain; Laboratory of Cognitive and Affective Neuroscience, Faculty of psychology, University of Valencia, Valencia, Spain. Electronic address: m.angel.serrano@uv.es.'}, {'ForeName': 'Ali Moghadam', 'Initials': 'AM', 'LastName': 'Zadeh', 'Affiliation': 'Department of Psychology, Faculty of Psychology and Education, University of Tehran, Tehran, Iran. Electronic address: amoghadamzadeh@ut.ac.ir.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Gazerani', 'Affiliation': 'Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg E, Denmark. Electronic address: gazerani@hst.aau.dk.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113173']
2887,32958010,From sensitization to adoption? A qualitative study of the implementation of a digitally supported intervention for clinical decision making in polypharmacy.,"OBJECTIVE
Formative evaluation of the implementation process for a digitally supported intervention in polypharmacy in Germany. Qualitative research was conducted within a cluster randomized controlled trial (C-RCT). It focused on understanding how the intervention influences behavior-related outcomes in the prescription and medication review process.
METHODS/SETTING
Twenty-seven general practitioners (GPs) were included in the study in the two groups of the C-RCT, the intervention, and the wait list control group. Behavior-related outcomes were investigated using three-step data analysis (content analytic approach, documentary method, and design of a model of implementation pathways).
RESULTS
Content analysis showed that physicians were more intensely aware of polypharmacy-related risks, described positive learning effects of the digital technology on their prescribing behavior, and perceived a change in communication with patients and pharmacists. Conversely, they felt uncertain about their own responsibility when prescribing. Three main dimensions were discovered which influenced adoption behavior: (1) the physicians' interpretation of the relevance of pharmaceutical knowledge provided by the intervention in changing decision-making situations in polypharmacy; (2) their medical code of ethics for clinical decision making in the context of progressing digitalization; and (3) their concepts of evidence-based medicine on the basis of professional experiences with polypharmacy in primary care settings. In our sample, both simple and complex pathways from sensitization to adoption were observed. The resulting model on adoption behavior includes a paradigmatic description of different pathways and a visualization of different observed levels and applied methodological approaches. We assumed that the GP habitus can weaken or strengthen interventional effects towards intervention uptake. This formative evaluation strategy is beneficial for the identification of behavior-related implementation barriers and facilitators.
CONCLUSION
Our analyses of the adoption behavior of a digitally supported intervention in polypharmacy revealed both simple and complex pathways from awareness to adoption, which may impact the implementation of the intervention and therefore, its effectiveness. Future consideration of adoption behavior in the planning and evaluation of digitally supported interventions may enhance uptake and support the interpretation of effects.
TRIAL REGISTRATION
NCT03430336 , 12 February 2018.",2020,"RESULTS
Content analysis showed that physicians were more intensely aware of polypharmacy-related risks, described positive learning effects of the digital technology on their prescribing behavior, and perceived a change in communication with patients and pharmacists.","['Twenty-seven general practitioners (GPs) were included in the study in the two groups of the C-RCT, the intervention, and the wait list control group', 'polypharmacy in Germany']",[],[],"[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]",[],[],,0.0552635,"RESULTS
Content analysis showed that physicians were more intensely aware of polypharmacy-related risks, described positive learning effects of the digital technology on their prescribing behavior, and perceived a change in communication with patients and pharmacists.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Söling', 'Affiliation': 'Institute for Medical Sociology, Health Services Research and Rehabilitation Science, Department of Health Services Research, University of Cologne, Cologne, Germany. sara.soeling@uk-koeln.de.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Köberlein-Neu', 'Affiliation': 'Center for Health Economics and Health Services Research, Schumpeter School of Business and Economics, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Beate Sigrid', 'Initials': 'BS', 'LastName': 'Müller', 'Affiliation': 'Institute of General Practice, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Truc Sophia', 'Initials': 'TS', 'LastName': 'Dinh', 'Affiliation': 'Institute of General Practice, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Muth', 'Affiliation': 'Institute of General Practice, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Pfaff', 'Affiliation': 'Institute for Medical Sociology, Health Services Research and Rehabilitation Science, Department of Health Services Research, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Karbach', 'Affiliation': 'Department Sociology in Rehabilitation, Faculty of Rehabilitation Sciences, Technical University Dortmund, Dortmund, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Implementation science : IS,['10.1186/s13012-020-01043-6']
2888,32958076,Effectiveness of a peer-based intervention on loneliness and social isolation of older Chinese immigrants in Canada: a randomized controlled trial.,"BACKGROUND
Social isolation is a key concern for immigrant older adults. We examined the effectiveness of a peer-based intervention in reducing loneliness, social isolation, and improving psychosocial well-being with a sample of aging Chinese immigrants.
METHODS
Sixty community-dwelling older Chinese immigrants aged 65 and older were randomly assigned to an intervention group and a control group (n = 30 each) in a randomized control parallel trial design. Intervention group participants received an eight-week peer support intervention. Twenty-four volunteers aged 48 to 76 engaged in two-on-one peer support through home visits and telephone calls to provide emotional support, problem-solving support, and community resource sharing. Social workers who are not blinded to the group assignment measured the changes of both the intervention group and the control group participants in a range of psychosocial outcomes including three primary outcomes (loneliness, social support, barriers to social participation) and five secondary outcomes (depressive symptoms, anxiety, life satisfaction, happiness, and purpose in life).
RESULTS
The 30 intervention group participants showed a statistically significant decrease in loneliness and increase in resilience when compared to the 30 control group participants. They reported fewer barriers to social participation, fewer depressive symptoms, increased life satisfaction, and happiness while no such improvements were observed in the control group.
CONCLUSIONS
There is a need to further examine the use of peer-based interventions for both program effectiveness and delivery efficiency. In the era of population aging and increasing immigration, diverse aging adults can be trained to fill volunteer support roles via peer-based intervention approaches.
TRIAL REGISTRATION
ISRCTN, ISRCTN14572069 , Registered 23 December 2019 - Retrospectively registered.",2020,The 30 intervention group participants showed a statistically significant decrease in loneliness and increase in resilience when compared to the 30 control group participants.,"['Registered 23 December 2019 - Retrospectively registered', 'older Chinese immigrants in Canada', 'immigrant older adults', 'Twenty-four volunteers aged 48 to 76 engaged in two-on-one peer support through home visits and telephone calls to provide emotional support, problem-solving support, and community resource sharing', 'Sixty community-dwelling older Chinese immigrants aged 65 and older']","['peer-based intervention', 'eight-week peer support intervention']","['loneliness and increase in resilience', 'depressive symptoms, increased life satisfaction, and happiness', 'outcomes (loneliness, social support, barriers to social participation) and five secondary outcomes (depressive symptoms, anxiety, life satisfaction, happiness, and purpose in life', 'loneliness and social isolation']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}]",24.0,0.0850471,The 30 intervention group participants showed a statistically significant decrease in loneliness and increase in resilience when compared to the 30 control group participants.,"[{'ForeName': 'Daniel W L', 'Initials': 'DWL', 'LastName': 'Lai', 'Affiliation': 'Faculty of Social Sciences, Hong Kong Baptist University, Hong Kong, China. daniel_lai@hkbu.edu.hk.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Ou', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Celia Y P', 'Initials': 'CYP', 'LastName': 'Li', 'Affiliation': ""The Calgary Chinese Elderly Citizens' Association, Calgary, Canada.""}]",BMC geriatrics,['10.1186/s12877-020-01756-9']
2889,32960464,Impact of the Goal-directed Medication Review Electronic Decision Support System on Drug Burden Index: A cluster-randomised clinical trial in primary care.,"AIMS
The Goal-directed Medication Review Electronic Decision Support System (G-MEDSS) assesses and reports a patient's goals, attitudes to deprescribing and Drug Burden Index (DBI) score, a measure of cumulative exposure to anticholinergic and sedative medications. This study evaluated the effect of implementing G-MEDSS in home medicines reviews (HMRs) on DBI exposure and clinical outcomes.
METHODS
A cluster-randomised clinical trial was performed across Australia. Accredited clinical pharmacists were randomised into intervention (G-MEDSS with usual care HMR) or comparison groups (usual care HMR alone). Patients were recruited by pharmacists from those routinely referred by general practitioners for HMR. The primary outcome was the proportion of patients with any reduction in DBI at 3-months follow-up. Secondary outcomes included change in DBI continuous score at 3-months, HMR recommendations to change DBI and clinical outcomes.
RESULTS
There were 201 patient participants at baseline (n = 88 intervention, n = 113 comparison), with 159 followed-up at 3-months (n = 63 intervention, n = 96 comparison). The proportion of patients with a reduction in DBI was not significantly different at 3-months (intervention 17%, comparison 11%; adjusted odds ratio 1.44, 95% confidence interval 0.56-3.80). Regarding secondary outcomes, there was no difference in change in DBI score at 3-months. However, the HMR report made recommendations to reduce DBI for a significantly greater proportion of patients in the intervention than in the comparison group (intervention 37%, comparison 14%; adjusted odds ratio 3.20, 95% confidence interval 1.50-6.90). No changes were observed in clinical outcomes.
CONCLUSION
Implementation of G-MEDSS within HMR did not reduce patients' DBI at 3 months compared with usual care HMR.",2020,"The proportion of patients with a reduction in DBI was not significantly different at 3-months (intervention 17%, comparison 11%; adjusted odds ratio (aOR)","['Patients were recruited by pharmacists from those routinely referred by general practitioners for HMR', '201 patient participants at baseline (n=88 intervention, n=113 comparison), with 159 followed-up at 3-months (n=63 intervention, n=96 comparison']","['implementing G-MEDSS', 'Goal-directed Medication review Electronic Decision Support System (G-MEDSS', 'intervention (G-MEDSS with usual care HMR) or comparison groups (usual care HMR alone']","['adjusted odds ratio (aOR', 'proportion of patients with any reduction in DBI', 'change in DBI continuous score at 3-months, HMR recommendations to change DBI and clinical outcomes', 'DBI score', 'DBI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",201.0,0.154378,"The proportion of patients with a reduction in DBI was not significantly different at 3-months (intervention 17%, comparison 11%; adjusted odds ratio (aOR)","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': ""Kouladjian O'Donnell"", 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Danijela', 'Initials': 'D', 'LastName': 'Gnjidic', 'Affiliation': 'Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Mouna', 'Initials': 'M', 'LastName': 'Sawan', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Reeve', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Kelly', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Chen', 'Affiliation': 'Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, New South Wales, Australia.'}, {'ForeName': 'J Simon', 'Initials': 'JS', 'LastName': 'Bell', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Sarah N', 'Initials': 'SN', 'LastName': 'Hilmer', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, St Leonards, New South Wales, Australia.'}]",British journal of clinical pharmacology,['10.1111/bcp.14557']
2890,32965537,"Author's Reply to Letters to the Editor: ""A comparison of endoscopic transtympanic myringoplasty and endoscopic type I tympanoplasty for repairing medium- to large-sized tympanic membrane perforation: a randomized clinical trial"".",,2020,,[],['endoscopic transtympanic myringoplasty and endoscopic type I tympanoplasty'],[],[],"[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0442388', 'cui_str': 'Transtympanic approach'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}]",[],,0.0406288,,"[{'ForeName': 'Viraporn', 'Initials': 'V', 'LastName': 'Atchariyasathian', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand. viraporn.a@psu.ac.th.'}, {'ForeName': 'Rata', 'Initials': 'R', 'LastName': 'Suwannajak', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand.'}, {'ForeName': 'Yuvatiya', 'Initials': 'Y', 'LastName': 'Plodpai', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand.'}, {'ForeName': 'Pittayapon', 'Initials': 'P', 'LastName': 'Pitathawatchai', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06376-y']
2891,32965539,"A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy.","PURPOSE
The purpose of this clinical study was to be the first to explore whether ART-123, a recombinant human soluble thrombomodulin, prevents oxaliplatin-induced peripheral neuropathy (OIPN).
METHODS
This randomized, phase IIa trial enrolled stage II/III colon cancer patients who received adjuvant mFOLFOX6 chemotherapy. Participants were randomly allocated to 3 arms in a double-blind manner: placebo (placebo: days 1-3); 1-day ART (ART-123: day 1, placebo: days 2-3); and 3-day ART (ART-123: days 1-3). ART-123 (380 U/kg/day) or placebo was infused intravenously before each 2-week cycle of mFOLFOX6. OIPN was assessed with the Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 (FACT/GOG-Ntx-12) score by participants and the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) by investigators.
RESULTS
Seventy-nine participants (placebo n = 28, 1-day ART n = 27, 3-day ART n = 24) received study drugs. The least-squares mean FACT/GOG-Ntx-12 scores at cycle 12 from the mixed effect model for repeated measures were 28.9 with placebo, 36.3 with 1-day ART (vs. placebo: 7.3 [95% CI 1.9 to12.8, p = 0.009]), and 32.3 with 3-day ART (vs. placebo: 3.4 [95% CI -.1 to 9.0, p = 0.222]). The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: -23.5 [95% CI -48.4 to 4.0], p = 0.108), and 45.8% with 3-day ART (vs. placebo: -18.5 [95% CI -44.2 to 9.4], p = 0.264). Common adverse events were consistent with those reported with mFOLFOX6; no severe bleeding adverse events occurred.
CONCLUSION
ART-123 showed a potential preventive effect against OIPN with good tolerability. A larger study with 1-day ART is warranted. NCT02792842, registration date: June 8, 2016.",2020,"The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: -23.5","['Seventy-nine participants (placebo n\u2009=\u200928, 1-day ART n\u2009=\u200927, 3-day ART n\u2009=\u200924) received study drugs', 'III colon cancer patients who received']","['ART-123', 'placebo', 'recombinant thrombomodulin (ART-123', 'adjuvant mFOLFOX6 chemotherapy', 'placebo (placebo: days 1-3); 1-day ART (ART-123: day 1, placebo']","['OIPN', 'severe bleeding adverse events', 'Neurotoxicity-12 (FACT/GOG-Ntx-12) score', 'cumulative incidence of NCI-CTCAE grade\u2009≥\u20092 sensory neuropathy']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1174887', 'cui_str': 'ART123'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}]",,0.727589,"The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: -23.5","[{'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Kotaka', 'Affiliation': 'Gastrointestinal Cancer Center, Sano Hospital, 2-5-1 Shimizugaoka, Tarumi-ku, Kobe-shi, Hyogo, 655-0031, Japan. tomomakotaka6410@yahoo.co.jp.'}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Anesthesiology, Shimane University Faculty of Medicine, 89-1 Enyacho, Izumo City, Shimane, 693-8501, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterological Surgery, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki-shi, Hyogo, 660-8511, Japan.'}, {'ForeName': 'Hironaga', 'Initials': 'H', 'LastName': 'Satake', 'Affiliation': 'Department of Medical Oncology, Kobe City Medical Center General Hospital, 2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan.'}, {'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, 1-8-1 Kishinoura, Yahatanishi-ku, Kitakyusyu-shi, Fukuoka, 806-8501, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medical Oncology, Tonan Hospital, Kita 4-jo Nishi 7-chome 3-8, Chuo-ku, Sapporo-shi, Hokkaido, 060-0004, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, 1-5-54 Ujinakanda, Minami-ku, Hiroshima-shi, Hiroshima, 734-8530, Japan.'}, {'ForeName': 'Toshiyoshi', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan.'}, {'ForeName': 'Tsunekazu', 'Initials': 'T', 'LastName': 'Mizushima', 'Affiliation': 'Department of Gastrointestinal Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Harihara', 'Affiliation': 'Department of Surgery, NTT Medical Center Tokyo, 5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo, 141-8625, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Nagata', 'Affiliation': 'Department of Surgery, Kitakyushu General Hospital, 1-1 Higashijono-machi, Kokurakita-ku, Kitakyushu, 802-8517, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kurihara', 'Affiliation': 'Department of Surgery, Nerima General Hospital, 1-24-1 Asahigaoka, Nerima-ku, Tokyo, 176-8530, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan.'}, {'ForeName': 'Genichi', 'Initials': 'G', 'LastName': 'Kusakawa', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Yugo', 'Initials': 'Y', 'LastName': 'Uchida', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Mikihiro', 'Initials': 'M', 'LastName': 'Takamoto', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kimoto', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04135-8']
2892,32961514,The Effect of Intradermal Botulinum Toxin a injections on painful diabetic polyneuropathy.,"BACKGROUND AND AIMS
Botulinum toxin type A (BTX-A) have been recently administered to improve Diabetic neuropathies; however, the efficacy of this treatment for relieving pain in painful diabetic polyneuropathy (DPN) has not been studied yet. Herein, we investigated the efficacy of botulinum toxin A (BTX-A) on DPN.
METHODS
This prospective, randomized, double-blind, controlled trial was performed in Imam Hossein Medical Center, pain clinic (Tehran, Iran). Diabetic patients (141 cases), between 40 and 70 years old with polyneuropathy in lower limbs were randomly assigned to one of these three groups: 1. Group D1 received 150 units of BTX-A in one foot and normal saline 0.9% in the other foot, 2. Group D2 received BTX-A 150 units in both feet, 3. Group N received normal saline 0.9% in both feet. All injections were performed intradermally using insulin syringes in 20 different points of foot. Visual analogue scale (VAS) and neuropathy pain scale (NPS) were used to compare the groups.
RESULTS
The improvement of VAS, pain intensity, sharp and hot sensation, sensitive and unpleasant sensation, deep and surface sensation was significant when comparing BTX-A and placebo groups. However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups. Furthermore, the percentage of changes after treatment indicated that sharp pain was improved more than other complaints (80%, 81%, and 37% for D1, D2, and N groups; respectively).
CONCLUSION
Intradermal administration of BTX-A was effective in improving VAS and all of the items of NPS in patients with diabetic polyneuropathy, except for dull and cold sensation.",2020,"However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups.","['painful diabetic polyneuropathy', 'patients with diabetic polyneuropathy', 'Imam Hossein Medical Center, pain clinic (Tehran, Iran', 'painful diabetic polyneuropathy (DPN', 'Diabetic patients (141 cases), between 40 and 70 years old with polyneuropathy in lower limbs']","['Intradermal Botulinum Toxin a injections', 'BTX-A in one foot and normal saline', 'botulinum toxin A (BTX-A', 'BTX', 'placebo', 'normal saline', 'BTX-A']","['dull and cold sensations improvement', 'sharp pain', 'VAS, pain intensity, sharp and hot sensation, sensitive and unpleasant sensation, deep and surface sensation', 'Visual analogue scale (VAS) and neuropathy pain scale (NPS']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0271680', 'cui_str': 'Diabetic polyneuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0278144', 'cui_str': 'Dull pain'}, {'cui': 'C0234192', 'cui_str': 'Cold'}, {'cui': 'C0455270', 'cui_str': 'Sharp pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",,0.20487,"However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups.","[{'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Taheri', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Meghdad', 'Initials': 'M', 'LastName': 'Sedaghat', 'Affiliation': 'Department of Internal Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Solhpour', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Rostami', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Safarpour Lima', 'Affiliation': 'Department of Neurology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: b.safarpour@sbmu.ac.ir.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.09.019']
2893,32966722,"Lower-Dose Zinc for Childhood Diarrhea - A Randomized, Multicenter Trial.","BACKGROUND
The World Health Organization recommends 20 mg of zinc per day for 10 to 14 days for children with acute diarrhea; in previous trials, this dosage decreased diarrhea but increased vomiting.
METHODS
We randomly assigned 4500 children in India and Tanzania who were 6 to 59 months of age and had acute diarrhea to receive 5 mg, 10 mg, or 20 mg of zinc sulfate for 14 days. The three primary outcomes were a diarrhea duration of more than 5 days and the number of stools (assessed in a noninferiority analysis) and the occurrence of vomiting (assessed in a superiority analysis) within 30 minutes after zinc administration.
RESULTS
The percentage of children with diarrhea for more than 5 days was 6.5% in the 20-mg group, 7.7% in the 10-mg group, and 7.2% in the 5-mg group. The difference between the 20-mg and 10-mg groups was 1.2 percentage points (upper boundary of the 98.75% confidence interval [CI], 3.3), and that between the 20-mg and 5-mg groups was 0.7 percentage points (upper boundary of the 98.75% CI, 2.8), both of which were below the noninferiority margin of 4 percentage points. The mean number of diarrheal stools was 10.7 in the 20-mg group, 10.9 in the 10-mg group, and 10.8 in 5-mg group. The difference between the 20-mg and 10-mg groups was 0.3 stools (upper boundary of the 98.75% CI, 1.0), and that between the 20-mg and 5-mg groups was 0.1 stools (upper boundary of the 98.75% CI, 0.8), both of which were below the noninferiority margin (2 stools). Vomiting within 30 minutes after administration occurred in 19.3%, 15.6%, and 13.7% of the patients in the 20-mg, 10-mg, and 5-mg groups, respectively; the risk was significantly lower in the 10-mg group than in the 20-mg group (relative risk, 0.81; 97.5% CI, 0.67 to 0.96) and in the 5-mg group than in the 20-mg group (relative risk, 0.71; 97.5% CI, 0.59 to 0.86). Lower doses were also associated with less vomiting beyond 30 minutes after administration.
CONCLUSIONS
Lower doses of zinc had noninferior efficacy for the treatment of diarrhea in children and were associated with less vomiting than the standard 20-mg dose. (Funded by the Bill and Melinda Gates Foundation; ZTDT ClinicalTrials.gov number, NCT03078842.).",2020,"Vomiting within 30 minutes after administration occurred in 19.3%, 15.6%, and 13.7% of the patients in the 20-mg, 10-mg, and 5-mg groups, respectively; the risk was significantly lower in the 10-mg group than in the 20-mg group (relative risk, 0.81; 97.5% CI, 0.67 to 0.96) and in the 5-mg group than in the 20-mg group (relative risk, 0.71; 97.5% CI, 0.59 to 0.86).","['children with acute diarrhea', '4500 children in India and Tanzania who were 6 to 59 months of age and had acute diarrhea', 'Childhood Diarrhea ']",['zinc sulfate'],"['percentage of children with diarrhea', 'Vomiting', 'occurrence of vomiting', 'diarrhea duration of more than 5 days and the number of stools', 'mean number of diarrheal stools', 'vomiting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C4517780', 'cui_str': '4500'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0444858', 'cui_str': 'AM 6'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",4500.0,0.0686028,"Vomiting within 30 minutes after administration occurred in 19.3%, 15.6%, and 13.7% of the patients in the 20-mg, 10-mg, and 5-mg groups, respectively; the risk was significantly lower in the 10-mg group than in the 20-mg group (relative risk, 0.81; 97.5% CI, 0.67 to 0.96) and in the 5-mg group than in the 20-mg group (relative risk, 0.71; 97.5% CI, 0.59 to 0.86).","[{'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Dhingra', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Rodrick', 'Initials': 'R', 'LastName': 'Kisenge', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Sudfeld', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Dhingra', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Somji', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Arup', 'Initials': 'A', 'LastName': 'Dutta', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bakari', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Deb', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Prabhabati', 'Initials': 'P', 'LastName': 'Devi', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Enju', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Aishwarya', 'Initials': 'A', 'LastName': 'Chauhan', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Jitendra', 'Initials': 'J', 'LastName': 'Kumar', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Om P', 'Initials': 'OP', 'LastName': 'Semwal', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Simon', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Sazawal', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Manji', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}]",The New England journal of medicine,['10.1056/NEJMoa1915905']
2894,32966810,"Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study.","BACKGROUND
Surufatinib showed superior efficacy in extrapancreatic neuroendocrine tumours (NETs) in the phase 3 SANET-ep study. In SANET-p, we aimed to assess the efficacy and safety of surufatinib in patients with advanced pancreatic NETs.
METHODS
SANET-p was a multicentre, randomised, double-blind, placebo-controlled, phase 3 study, done in 21 hospitals across China. Eligible patients were adults (aged 18 years or older) with progressive, advanced, well differentiated pancreatic NETs, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and progression on up to two kinds of previous systemic regimens for advanced disease. Patients were randomly assigned (2:1) via an interactive web response system to receive 300 mg of surufatinib or placebo, taken orally once per day in consecutive 4-week treatment cycles until disease progression, intolerable toxicity, withdrawal of consent, poor compliance, use of other antitumour medication, pregnancy, loss to follow-up, or if the investigator deemed discontinuation in the patient's best interest. Randomisation was done centrally using stratified block randomisation (block size three), stratified by pathological grade, previous systemic antitumour treatment, and ECOG performance status score. Patients, investigators, research staff, and the sponsor study team were masked to treatment allocation. Crossover to surufatinib was permitted for patients in the placebo group with disease progression. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population, which included all patients in randomisation. A pre-planned interim analysis was done at 70% of the predicted progression-free survival events. This study is registered at ClinicalTrials.gov, NCT02589821.
FINDINGS
Between Feb 18, 2016, and Nov 11, 2019, of 264 patients who were screened, 172 (65%) patients were randomly assigned to receive surufatinib (n=113) or placebo (n=59). The median follow-up was 19·3 months (95% CI 9·3-19·4) in the surufatinib group and 11·1 months (5·7-35·9) in the placebo group. The median investigator-assessed progression-free survival was 10·9 months (7·5-13·8) for surufatinib versus 3·7 months (2·8-5·6) for placebo (hazard ratio 0·49, 95% CI 0·32-0·76; p=0·0011). The trial met the early stopping criteria at the interim analysis and was terminated on recommendation from the independent data monitoring committee. The most common grade 3 or worse treatment-related adverse events were hypertension (43 [38%] of 113 with surufatinib vs four [7%] of 59 with placebo), proteinuria (11 [10%] vs one [2%]), and hypertriglyceridaemia (eight [7%] vs none). Treatment-related serious adverse events were reported in 25 (22%) patients in the surufatinib group and four (7%) patients in the placebo group. There were three on-treatment deaths in the surufatinib group, including two deaths due to adverse events (gastrointestinal haemorrhage [possibly treatment-related] and cerebral haemorrhage [unlikely to be treatment-related]), and one death attributed to disease progression. One on-treatment death in the placebo group was attributed to disease progression.
INTERPRETATION
Surufatinib significantly improves progression-free survival and has an acceptable safety profile in patients with progressive, advanced pancreatic NETs, and could be a potential treatment option in this patient population.
FUNDING
Hutchison MediPharma.",2020,The median investigator-assessed progression-free survival was 10·9 months (7·5-13·8) for surufatinib versus 3·7 months (2·8-5·6) for placebo (hazard ratio,"['patients with advanced pancreatic NETs', '21 hospitals across China', 'Between Feb 18, 2016, and Nov 11, 2019, of 264 patients who were screened, 172 (65%) patients', 'advanced pancreatic neuroendocrine tumours (SANET-p', 'Eligible patients were adults (aged 18 years or older) with progressive, advanced, well differentiated pancreatic NETs, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and progression on up to two kinds of previous systemic regimens for advanced disease', 'group with disease progression', 'patients with progressive, advanced pancreatic NETs']","['interactive web response system to receive 300 mg of surufatinib or placebo', 'surufatinib', 'placebo']","['hypertriglyceridaemia', 'proteinuria', 'adverse events (gastrointestinal haemorrhage', 'disease progression', 'efficacy and safety', 'median investigator-assessed progression-free survival', 'cerebral haemorrhage', 'treatment deaths', 'progression-free survival', 'serious adverse events', 'investigator-assessed progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0242363', 'cui_str': 'Pancreatic endocrine tumor'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.710105,The median investigator-assessed progression-free survival was 10·9 months (7·5-13·8) for surufatinib versus 3·7 months (2·8-5·6) for placebo (hazard ratio,"[{'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China. Electronic address: jmxu2003@yahoo.com.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Xianjun', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Abdominal Oncology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Enxiao', 'Initials': 'E', 'LastName': 'Li', 'Affiliation': ""Department of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Xianglin', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yihebali', 'Initials': 'Y', 'LastName': 'Chi', 'Affiliation': 'National Cancer Center and Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yongmei', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Lou', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Dianrong', 'Initials': 'D', 'LastName': 'Xiu', 'Affiliation': 'Department of General Surgery, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Xiuwen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""People's Liberation Army Cancer Center of Nanjing Jinling Hospital, Nanjing, China.""}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Jia', 'Affiliation': 'Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Yuejuan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Medical Oncology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastric Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Clinical and Regulatory Affairs, Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Clinical and Regulatory Affairs, Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Department of Clinical and Regulatory Affairs, Hutchison MediPharma, Shanghai, China.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30493-9']
2895,32966811,"Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study.","BACKGROUND
Therapeutic options for advanced neuroendocrine tumours (NETs) are limited. We investigated the efficacy and safety of surufatinib (HMPL-012, sulfatinib) in patients with extrapancreatic NETs.
METHODS
SANET-ep was a randomised, double-blind, placebo-controlled, phase 3 trial undertaken at 24 hospitals across China. Patients (aged 18 years or older) with unresectable or metastatic, well differentiated, extrapancreatic NETs, with an Eastern Cooperative Oncology Group performance status of 0 or 1, and progression on no more than two types of previous systemic regimens were enrolled. Patients were centrally randomly assigned (2:1) using stratified block randomisation (block size 3) via an interactive web response system to receive oral surufatinib at 300 mg per day or matching placebo. Randomisation was stratified by tumour origin, pathological grade, and previous treatment. Patients, investigators, research staff and the sponsor study team were masked to treatment allocation. Crossover to the surufatinib group was allowed for patients in the placebo group at disease progression. The primary endpoint was investigator-assessed progression-free survival, which was analysed in the intention-to-treat population. A preplanned interim analysis was done at 70% of predicted progression-free survival events. This study was registered with ClinicalTrials.gov, NCT02588170. Follow-up is ongoing.
FINDINGS
Between Dec 9, 2015, and March 31, 2019, 198 patients were randomly assigned to surufatinib (n=129) or placebo (n=69). Median follow-up was 13·8 months (95% CI 11·1-16·7) in the surufatinib group and 16·6 months (9·2-not calculable) in the placebo group. Investigator-assessed median progression-free survival was 9·2 months (95% CI 7·4-11·1) in the surufatinib group versus 3·8 months (3·7-5·7) in the placebo group (hazard ratio 0·33; 95% CI 0·22-0·50; p<0·0001). As the trial met the predefined criteria for early discontinuation of the study at the interim analysis, the study was terminated early, as recommended by the independent data monitoring committee. The most common treatment-related adverse events of grade 3 or worse were hypertension (47 [36%] of 129 patients in the surufatinib group vs nine [13%] of 68 patients in the placebo group) and proteinuria (25 [19%] vs zero). Treatment-related serious adverse events were reported in 32 (25%) of 129 patients in the surufatinib group and nine (13%) of 68 patients in the placebo group. Treatment-related deaths occurred in three patients in the surufatinib group (disseminated intravascular coagulation and hepatic encephalopathy, liver injury, and death with unknown reason) and one patient in the placebo group (cachexia and respiratory failure).
INTERPRETATION
Progression-free survival was significantly longer in patients given surufatinib compared with patients given placebo, and surufatinib has a favourable benefit-to-risk profile in patients with progressive, advanced, well differentiated extrapancreatic NETs. Our results suggest that surufatinib might be a new treatment option for this population.
FUNDING
Hutchison MediPharma.",2020,Treatment-related serious adverse events were reported in 32 (25%) of 129 patients in the surufatinib group and nine (13%) of 68 patients in the placebo group.,"['advanced extrapancreatic neuroendocrine tumours (SANET-ep', '24 hospitals across China', 'patients with extrapancreatic NETs', 'advanced neuroendocrine tumours (NETs', 'Patients (aged 18 years or older) with unresectable or metastatic, well differentiated, extrapancreatic NETs, with an Eastern Cooperative Oncology Group performance status of 0 or 1, and progression on no more than two types of previous systemic regimens were enrolled', '198 patients were randomly assigned to surufatinib (n=129) or', 'Between Dec 9, 2015, and March 31, 2019']","['placebo', 'surufatinib (HMPL-012, sulfatinib', 'stratified block randomisation (block size 3) via an interactive web response system to receive oral surufatinib at 300 mg per day or matching placebo']","['progression-free survival events', 'Progression-free survival', 'deaths', 'Investigator-assessed median progression-free survival', 'hypertension', 'serious adverse events', 'investigator-assessed progression-free survival']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",198.0,0.726932,Treatment-related serious adverse events were reported in 32 (25%) of 129 patients in the surufatinib group and nine (13%) of 68 patients in the placebo group.,"[{'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China. Electronic address: jmxu2003@yahoo.com.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastric Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yihebali', 'Initials': 'Y', 'LastName': 'Chi', 'Affiliation': 'National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Abdominal Oncology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Enxiao', 'Initials': 'E', 'LastName': 'Li', 'Affiliation': ""Department of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Zhongshan Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Xingya', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xiuwen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Jieer', 'Initials': 'J', 'LastName': 'Ying', 'Affiliation': 'Department of Abdominal Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Xianjun', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""People's Liberation Army Cancer Center of Nanjing Jinling Hospital, Nanjing, China.""}, {'ForeName': 'Xianglin', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases l, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Dianrong', 'Initials': 'D', 'LastName': 'Xiu', 'Affiliation': 'Department of General Surgery, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Thoracic Oncology, Jilin Provincial Cancer Hospital, Changchun, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tao', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Jia', 'Affiliation': 'Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Development and Regulatory Affairs, Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Songhua', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Department of Clinical Development and Regulatory Affairs, Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Mengye', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Department of Clinical Development and Regulatory Affairs, Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Department of Clinical Development and Regulatory Affairs, Hutchison MediPharma, Shanghai, China.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30496-4']
2896,32985775,Withdrawal of medications leads to worsening of OGTT parameters in youth with impaired glucose tolerance or recently-diagnosed type 2 diabetes.,"BACKGROUND
The RISE Pediatric Medication Study compared strategies for preserving β-cell function, including a 9-month follow-up after treatment withdrawal to test treatment effect durability.
OBJECTIVE
Evaluate OGTT measures of glucose and β-cell response through 12 months of intervention and 9 months of medication washout.
PARTICIPANTS
Youth (n = 91) aged 10 to 19 years with BMI ≥85th percentile and impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes (T2D).
METHODS
A multicenter randomized clinical trial comparing insulin glargine for 3 months followed by metformin for 9 months (G→Met) or metformin alone (Met) for 12 months. We report within-group changes from baseline to end of medication intervention (M12), baseline to 9 months post-medication withdrawal (M21), and end of medication (M12) to M21. OGTT C-peptide index [CPI] paired with 1/fasting insulin evaluated β-cell response.
RESULTS
At M12, both treatments were associated with stable fasting glucose (G→Met baseline 6.0 ± 0.1 vs M12 5.9 ± 0.2 mmol/L, P = .62; Met baseline 6.1 ± 0.2 vs M12 6.0 ± 0.2 mmol/L, P = .73) and 2-hour glucose (G→Met baseline 10.2 ± 0.4 vs M12 9.3 ± 0.5 mmol/L, P = .03; Met baseline 10.2 ± 0.4 vs M12 10.6 ± 0.6 mmol/L, P = .88). Following medication withdrawal, fasting glucose worsened (G→Met M21 8.6 ± 1.8, P = .004; Met M21 7.8 ± 0.7 mmol/L, P = .003), as did 2-hour glucose (G→Met M21 13.2 ± 1.4, P = .002; Met M21 13.1 ± 1.2 mmol/L, P = .006), associated with declines in β-cell response.
CONCLUSIONS
G→Met and Met were associated with stable glucose measures during 12 months of treatment in youth with IGT or recently diagnosed T2D. Glucose and β-cell response worsened post-medication withdrawal, suggesting treatment must be long-term or alternative treatments pursued.",2020,"Following medication withdrawal, fasting glucose worsened (G→Met M21 8.6±1.8, p=0.004; Met M21 7.8±0.7 mmol/L, p=0.003), as did 2-hour glucose (G→Met M21 13.2±1.4, p=0.002; Met M21 13.1±1.2 mmol/L, p=0.006), associated with declines in β-cell response.
","['Youth (n=91) aged 10-19\u2009years with BMI ≥85th percentile and impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes (T2D', 'Youth with Impaired Glucose Tolerance or Recently-Diagnosed Type 2 Diabetes']","['insulin glargine', 'metformin']","['stable fasting glucose', 'fasting glucose', 'glucose and β-cell response', 'stable glucose measures', 'β-cell response']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",91.0,0.022497,"Following medication withdrawal, fasting glucose worsened (G→Met M21 8.6±1.8, p=0.004; Met M21 7.8±0.7 mmol/L, p=0.003), as did 2-hour glucose (G→Met M21 13.2±1.4, p=0.002; Met M21 13.1±1.2 mmol/L, p=0.006), associated with declines in β-cell response.
","[{'ForeName': 'Tamara S', 'Initials': 'TS', 'LastName': 'Hannon', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Edelstein', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, Maryland, USA.'}, {'ForeName': 'Silva A', 'Initials': 'SA', 'LastName': 'Arslanian', 'Affiliation': ""University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Caprio', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Zeitler', 'Affiliation': ""University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': 'University of Southern California, Keck School of Medicine, Los Angeles, California, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ehrmann', 'Affiliation': 'University of Chicago, Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tripputi', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, Maryland, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'VA Puget Sound Health Care System and University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ""University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric diabetes,['10.1111/pedi.13129']
2897,32979939,"High-dose and low-dose varenicline for smoking cessation in adolescents: a randomised, placebo-controlled trial.","BACKGROUND
Although cigarette smoking typically begins in adolescence, evidence for successful pharmacological smoking cessation interventions for this population is scarce. In adult smokers, varenicline is the most effective single pharmacotherapy. The aim of this study was to assess the efficacy and tolerability of varenicline for smoking cessation in adolescents.
METHODS
We did a randomised, placebo-controlled trial with adolescent smokers aged 12-19 years who were seeking treatment to quit at 57 outpatient centres (in the USA, Russia, South Korea, Taiwan, Canada, and Georgia). Participants were randomly assigned (1:1:1) to receive 12 weeks of high-dose varenicline (1 mg twice daily; 0·5 mg twice daily if bodyweight ≤55 kg), low-dose varenicline (0·5 mg twice daily; 0·5 mg once daily if bodyweight ≤55 kg), or placebo, then followed up for 40 additional weeks. At all visits, participants received brief, developmentally tailored smoking cessation counselling (<10 min per session) delivered by a trained counsellor. The primary efficacy outcome was continuous abstinence from weeks 9 to 12, measured via a Nicotine Use Inventory and confirmed by urine cotinine testing. The primary tolerability outcome was frequency of treatment-emergent adverse events, including neuropsychiatric adverse events, occurring after the first dose and within 30 days of the last dose of study medication. This trial is registered with ClinicalTrials.gov, NCT01312909.
FINDINGS
Between April 26, 2011, and Jan 18, 2018, 312 participants were enrolled and completed participation in the study: 109 in the high-dose varenicline group, 103 in the low-dose varenicline group, and 100 in the placebo group. The continuous abstinence rates from week 9 to 12 were 20% (22 of 109) in the high-dose varenicline group, 27% (28 of 103) in the low-dose varenicline group, and 18% (18 of 100) in the placebo group. Abstinence rates between high-dose varenicline and placebo groups (odds ratio [OR] 1·18 [95% CI 0·59-2·37]; p=0·63) and between low-dose varenicline and placebo groups (1·73 [0·88-3·39]; p=0·11) did not differ significantly. Treatment-emergent adverse events occurred in 65 (60%) of 108 participants in the high-dose group, 53 (53%) of 100 in the low-dose group, and 52 (53%) of 99 in the placebo group, and most were rated as mild. Neuropsychiatric treatment-emergent adverse events occurred in 18 (17%) of 108 participants in the high-dose group, 11 (11%) of 100 in the low-dose group, and 12 (12%) of 99 in the placebo group, and none was rated as severe.
INTERPRETATION
This trial did not show an advantage in abstinence with varenicline compared with placebo among adolescent smokers. The rates of treatment-emergent adverse events were similar to those in previous trials of adult smokers, raising no new tolerability signals. These findings do not support the use of varenicline as a first-line pharmacotherapy for smoking cessation in adolescents.
FUNDING
Pfizer.",2020,"Neuropsychiatric treatment-emergent adverse events occurred in 18 (17%) of 108 participants in the high-dose group, 11 (11%) of 100 in the low-dose group, and 12 (12%) of 99 in the placebo group, and none was rated as severe.
","['adolescent smokers', 'adolescents', 'adolescent smokers aged 12-19 years who were seeking treatment to quit at 57 outpatient centres (in the USA, Russia, South Korea, Taiwan, Canada, and Georgia', 'Between April 26, 2011, and Jan 18, 2018, 312 participants were enrolled and completed participation in the study: 109 in the high-dose varenicline group, 103 in the low-dose varenicline group, and 100 in the placebo group']","['placebo', 'High-dose and low-dose varenicline', 'varenicline', 'tailored smoking cessation counselling']","['continuous abstinence from weeks 9 to 12, measured via a Nicotine Use Inventory and confirmed by urine cotinine testing', 'Abstinence rates', 'rates of treatment-emergent adverse events', 'Treatment-emergent adverse events', 'severe', 'continuous abstinence rates', 'frequency of treatment-emergent adverse events, including neuropsychiatric adverse events', 'efficacy and tolerability', 'Neuropsychiatric treatment-emergent adverse events']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0017452', 'cui_str': 'Georgia state'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0303400', 'cui_str': 'Indium-109'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1697737', 'cui_str': 'Urine cotinine test'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",312.0,0.620913,"Neuropsychiatric treatment-emergent adverse events occurred in 18 (17%) of 108 participants in the high-dose group, 11 (11%) of 100 in the low-dose group, and 12 (12%) of 99 in the placebo group, and none was rated as severe.
","[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA. Electronic address: graykm@musc.edu.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Rubinstein', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'DuBrava', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Ann R', 'Initials': 'AR', 'LastName': 'Holstein', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Samuels', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'McRae', 'Affiliation': 'Pfizer, New York, NY, USA.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30243-1']
2898,32979978,"Gabapentin for chronic pelvic pain in women (GaPP2): a multicentre, randomised, double-blind, placebo-controlled trial.","BACKGROUND
Chronic pelvic pain affects 2-24% of women worldwide and evidence for medical treatments is scarce. Gabapentin is effective in treating some chronic pain conditions. We aimed to measure the efficacy and safety of gabapentin in women with chronic pelvic pain and no obvious pelvic pathology.
METHODS
We performed a multicentre, randomised, double-blind, placebo-controlled randomised trial in 39 UK hospital centres. Eligible participants were women with chronic pelvic pain (with or without dysmenorrhoea or dyspareunia) of at least 3 months duration. Inclusion criteria were 18-50 years of age, use or willingness to use contraception to avoid pregnancy, and no obvious pelvic pathology at laparoscopy, which must have taken place at least 2 weeks before consent but less than 36 months previously. Participants were randomly assigned in a 1:1 ratio to receive gabapentin (titrated to a maximum dose of 2700 mg daily) or matching placebo for 16 weeks. The online randomisation system minimised allocations by presence or absence of dysmenorrhoea, psychological distress, current use of hormonal contraceptives, and hospital centre. The appearance, route, and administration of the assigned intervention were identical in both groups. Patients, clinicians, and research staff were unaware of the trial group assignments throughout the trial. Participants were unmasked once they had provided all outcome data at week 16-17, or sooner if a serious adverse event requiring knowledge of the study drug occurred. The dual primary outcome measures were worst and average pain scores assessed separately on a numerical rating scale in weeks 13-16 after randomisation, in the intention-to-treat population. Self-reported adverse events were assessed according to intention-to-treat principles. This trial is registered with the ISRCTN registry, ISCRTN77451762.
FINDINGS
Participants were screened between Nov 30, 2015, and March 6, 2019, and 306 were randomly assigned (153 to gabapentin and 153 to placebo). There were no significant between-group differences in both worst and average numerical rating scale (NRS) pain scores at 13-16 weeks after randomisation. The mean worst NRS pain score was 7·1 (standard deviation [SD] 2·6) in the gabapentin group and 7·4 (SD 2·2) in the placebo group. Mean change from baseline was -1·4 (SD 2·3) in the gabapentin group and -1·2 (SD 2·1) in the placebo group (adjusted mean difference -0·20 [97·5% CI -0·81 to 0·42]; p=0·47). The mean average NRS pain score was 4·3 (SD 2·3) in the gabapentin group and 4·5 (SD 2·2) in the placebo group. Mean change from baseline was -1·1 (SD 2·0) in the gabapentin group and -0·9 (SD 1·8) in the placebo group (adjusted mean difference -0·18 [97·5% CI -0·71 to 0·35]; p=0·45). More women had a serious adverse event in the gabapentin group than in the placebo group (10 [7%] of 153 in the gabapentin group compared with 3 [2%] of 153 in the placebo group; p=0·04). Dizziness, drowsiness, and visual disturbances were more common in the gabapentin group.
INTERPRETATION
This study was adequately powered, but treatment with gabapentin did not result in significantly lower pain scores in women with chronic pelvic pain, and was associated with higher rates of side-effects than placebo. Given the increasing reports of abuse and evidence of potential harms associated with gabapentin use, it is important that clinicians consider alternative treatment options to off-label gabapentin for the management of chronic pelvic pain and no obvious pelvic pathology.
FUNDING
National Institute for Health Research.",2020,The mean average NRS pain score was 4·3 (SD 2·3) in the gabapentin group and 4·5,"['women with chronic pelvic pain', '39 UK hospital centres', 'Eligible participants were women with chronic pelvic pain (with or without dysmenorrhoea or dyspareunia) of at least 3 months duration', 'women with chronic pelvic pain and no obvious pelvic pathology', 'Inclusion criteria were 18-50 years of age, use or willingness to use contraception to avoid pregnancy, and no obvious pelvic pathology at laparoscopy, which must have taken place at least 2 weeks before consent but less than 36 months previously', 'chronic pelvic pain in women (GaPP2', 'Participants were screened between Nov 30, 2015, and March 6, 2019, and 306 were randomly assigned (153 to']","['Gabapentin', 'gabapentin', 'placebo', 'gabapentin (titrated to a maximum dose of 2700 mg daily) or matching placebo', 'gabapentin and 153 to placebo']","['mean worst NRS pain score', 'mean average NRS pain score', 'efficacy and safety', 'average numerical rating scale (NRS) pain scores', 'serious adverse event', 'average pain scores assessed separately on a numerical rating scale', 'Self-reported adverse events', 'Dizziness, drowsiness, and visual disturbances', 'pain scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4546343', 'cui_str': 'Uses contraception'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517675', 'cui_str': '2700'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0547030', 'cui_str': 'Visual disturbance'}]",39.0,0.778431,The mean average NRS pain score was 4·3 (SD 2·3) in the gabapentin group and 4·5,"[{'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Horne', 'Affiliation': ""MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK. Electronic address: andrew.horne@ed.ac.uk.""}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Vincent', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, UK.""}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Hewitt', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Lee J', 'Initials': 'LJ', 'LastName': 'Middleton', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Koscielniak', 'Affiliation': ""MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Szubert', 'Affiliation': ""MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Doust', 'Affiliation': ""MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Jane P', 'Initials': 'JP', 'LastName': 'Daniels', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31693-7']
2899,32979984,"Neoadjuvant chemotherapy and nivolumab in resectable non-small-cell lung cancer (NADIM): an open-label, multicentre, single-arm, phase 2 trial.","BACKGROUND
Non-small-cell lung cancer (NSCLC) is terminal in most patients with locally advanced stage disease. We aimed to assess the antitumour activity and safety of neoadjuvant chemoimmunotherapy for resectable stage IIIA NSCLC.
METHODS
This was an open-label, multicentre, single-arm phase 2 trial done at 18 hospitals in Spain. Eligible patients were aged 18 years or older with histologically or cytologically documented treatment-naive American Joint Committee on Cancer-defined stage IIIA NSCLC that was deemed locally to be surgically resectable by a multidisciplinary clinical team, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received neoadjuvant treatment with intravenous paclitaxel (200 mg/m 2 ) and carboplatin (area under curve 6; 6 mg/mL per min) plus nivolumab (360 mg) on day 1 of each 21-day cycle, for three cycles before surgical resection, followed by adjuvant intravenous nivolumab monotherapy for 1 year (240 mg every 2 weeks for 4 months, followed by 480 mg every 4 weeks for 8 months). The primary endpoint was progression-free survival at 24 months, assessed in the modified intention-to-treat population, which included all patients who received neoadjuvant treatment, and in the per-protocol population, which included all patients who had tumour resection and received at least one cycle of adjuvant treatment. Safety was assessed in the modified intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT03081689, and is ongoing but no longer recruiting patients.
FINDINGS
Between April 26, 2017, and Aug 25, 2018, we screened 51 patients for eligibility, of whom 46 patients were enrolled and received neoadjuvant treatment. At the time of data cutoff (Jan 31, 2020), the median duration of follow-up was 24·0 months (IQR 21·4-28·1) and 35 of 41 patients who had tumour resection were progression free. At 24 months, progression-free survival was 77·1% (95% CI 59·9-87·7). 43 (93%) of 46 patients had treatment-related adverse events during neoadjuvant treatment, and 14 (30%) had treatment-related adverse events of grade 3 or worse; however, none of the adverse events were associated with surgery delays or deaths. The most common grade 3 or worse treatment-related adverse events were increased lipase (three [7%]) and febrile neutropenia (three [7%]).
INTERPRETATION
Our results support the addition of neoadjuvant nivolumab to platinum-based chemotherapy in patients with resectable stage IIIA NSCLC. Neoadjuvant chemoimmunotherapy could change the perception of locally advanced lung cancer as a potentially lethal disease to one that is curable.
FUNDING
Bristol-Myers Squibb, Instituto de Salud Carlos III, European Union's Horizon 2020 research and innovation programme.",2020,"At 24 months, progression-free survival was 77·1% (95% CI 59·9-87·7).","['18 hospitals in Spain', 'resectable non-small-cell lung cancer (NADIM', 'Between April 26, 2017, and Aug 25, 2018, we screened 51 patients for eligibility, of whom 46 patients were enrolled and received neoadjuvant treatment', 'patients with resectable stage IIIA NSCLC', 'patients with locally advanced stage disease', 'Eligible patients were aged 18 years or older with histologically or cytologically documented treatment-naive American Joint Committee on Cancer-defined stage IIIA NSCLC that was deemed locally to be surgically resectable by a multidisciplinary clinical team, and an Eastern Cooperative Oncology Group performance status of 0 or 1']","['carboplatin (area under curve 6; 6 mg/mL per min) plus nivolumab', 'Neoadjuvant chemotherapy and nivolumab', 'Neoadjuvant chemoimmunotherapy', 'intravenous paclitaxel', 'platinum-based chemotherapy', 'neoadjuvant chemoimmunotherapy']","['febrile neutropenia', 'Safety', 'surgery delays or deaths', 'adverse events', 'median duration', 'antitumour activity and safety', 'progression-free survival']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0278983', 'cui_str': 'Non-small cell lung cancer stage IIIA'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",46.0,0.32459,"At 24 months, progression-free survival was 77·1% (95% CI 59·9-87·7).","[{'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Provencio', 'Affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain. Electronic address: mprovenciop@gmail.com.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Nadal', 'Affiliation': ""Institut Català d'Oncologia, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Insa', 'Affiliation': 'Fundación INCLIVA, Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'María Rosario', 'Initials': 'MR', 'LastName': 'García-Campelo', 'Affiliation': 'Hospital Universitario A Coruña, A Coruña, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Casal-Rubio', 'Affiliation': 'Hospital Universitario de Vigo, Pontevedra, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Dómine', 'Affiliation': 'Instituto de Investigación Sanitaria Fundación Jiménez Díaz (IIS-FJD), Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Hospital de la Santa Creu I Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodríguez-Abreu', 'Affiliation': 'Hospital Insular de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Martínez-Martí', 'Affiliation': ""Hospital Universitario e Instituto de Oncología Vall d'Hebron (VHIO), Barcelona, Spain.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'De Castro Carpeño', 'Affiliation': 'Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Hospital Universitario Regional de Málaga, Málaga, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'López Vivanco', 'Affiliation': 'Hospital Universitario Cruces, Barakaldo, Spain.'}, {'ForeName': 'Edel', 'Initials': 'E', 'LastName': 'Del Barco', 'Affiliation': 'Hospital Universitario de Salamanca, Salamanca, Spain.'}, {'ForeName': 'Reyes', 'Initials': 'R', 'LastName': 'Bernabé Caro', 'Affiliation': 'Hospital Universitario Virgen del Rocio, Seville, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Viñolas', 'Affiliation': 'Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Isidoro', 'Initials': 'I', 'LastName': 'Barneto Aranda', 'Affiliation': 'Hospital Universitario Reina Sofia, Córdoba, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Viteri', 'Affiliation': 'Instituto Oncológico Dr Rosell, Hospital Universitari Dexeus-Grupo Quironsalud, Barcelona, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Pereira', 'Affiliation': 'Spanish Lung Cancer Group, Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Royuela', 'Affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain; Consortium for Biomedical Research in Epidemiology and Public Health (CIBERESP), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Casarrubios', 'Affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Salas Antón', 'Affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.'}, {'ForeName': 'Edwin R', 'Initials': 'ER', 'LastName': 'Parra', 'Affiliation': 'Department of Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Wistuba', 'Affiliation': 'Department of Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Calvo', 'Affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Laza-Briviesca', 'Affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.'}, {'ForeName': 'Atocha', 'Initials': 'A', 'LastName': 'Romero', 'Affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.'}, {'ForeName': 'Bartomeu', 'Initials': 'B', 'LastName': 'Massuti', 'Affiliation': 'Hospital General de Alicante, Alicante, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Cruz-Bermúdez', 'Affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30453-8']
2900,32956906,Reality check: An experimental manipulation of inferential confusion in eating disorders.,"BACKGROUND AND OBJECTIVES
Inferential confusion (IC) entails confusing an imagined possibility with a sensory-based possibility, and acting upon the imagined possibility as if it was real. Although IC was formulated in the context of obsessive-compulsive disorder (OCD), this reasoning bias has shown to be relevant to other obsessive-compulsive spectrum disorders, such as eating disorders (EDs). The goal of this study was to induce IC experimentally in individuals with EDs relative to healthy controls (HC).
METHODS
Thirty-six women (ED group, n = 18; HC group, n = 18) were assigned to one of two experimental conditions: in the High IC condition, participants watched ED-themed videos with key sequences missing - provoking a distrust of the senses and lending more space for the imagination, thus triggering IC. In the Low IC condition, participants watched videos without sequences missing. Participants completed measures of IC, negative affect and compulsive behaviors after watching the videos.
RESULTS
One-way ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors. ED participants also neutralized more after watching the videos and endorsed higher trait IC.
LIMITATIONS
There was no clinical control group.
CONCLUSIONS
These findings suggest that individuals with EDs display a greater vulnerability to IC, as they are more prone to compulsive behaviors when IC is triggered. This investigation may foster our understanding of the relationship between EDs and OCD through the examination of cognitive factors that are implicated in both disorders.",2020,ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors.,"['Thirty-six women (ED group, n\xa0=\xa018', 'individuals with EDs relative to healthy controls (HC', 'eating disorders']","['watched ED-themed videos with key sequences missing - provoking a distrust of the senses and lending more space for the imagination, thus triggering IC']","['urge to engage in compulsive behaviors', 'IC, negative affect and compulsive behaviors']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1867020', 'cui_str': 'Scalp, ear, nipple syndrome'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0020913', 'cui_str': 'Use of imagination'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",36.0,0.0589645,ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ouellet-Courtois', 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychology Department, Canada. Electronic address: catherine.ouellet-courtois@umontreal.ca.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Aardema', 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychiatry Department, 2900, Boul. Édouard-Montpetit Montreal, Quebec, H3T 1J4, Canada.'}, {'ForeName': 'Kieron', 'Initials': 'K', 'LastName': ""O'Connor"", 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychiatry Department, 2900, Boul. Édouard-Montpetit Montreal, Quebec, H3T 1J4, Canada.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101614']
2901,32956960,Mental health promotion and prevention interventions in families with parental depression: A randomized controlled trial.,"BACKGROUND
The transgenerational transmission of affective disorders calls for integrating promotion of child development in the services offered to families with parental depression. The main objective of the present research was to examine the effectiveness and differences in the impact of two relevant interventions in Greece.
METHODS
Thirty families of depressed patients were randomly assigned to the six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session Let's Talk about the Children group. Depressed parents and the eldest of their children were assessed prior to the interventions and 4, 10, and 18 months following baseline assessment.
RESULTS
In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems. Child's prosocial behavior, perceived social support, and health-related quality of life were significantly improved in both groups. All positive effects were evident four months following baseline assessment and could be still documented at 1.5-year follow-up. Mixed linear models showed that family functioning and parenting to a lesser extent were associated with the greatest changes in children's psychosocial outcomes in both interventions..
LIMITATIONS
The lack of data regarding parents that refused to receive the interventions may limit generalizability of results. A further limitation is the lack of a no-intervention control group.
CONCLUSIONS
The study offers a preliminary evidence base for integrating preventive interventions for child mental health in routine clinical practice with adult depressed patients.",2020,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","['families with parental depression', 'Thirty families of depressed patients', 'child mental health in routine clinical practice with adult depressed patients']","['Mental health promotion and prevention interventions', 'six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session']","[""parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems"", ""Child's prosocial behavior, perceived social support, and health-related quality of life""]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",32.0,0.0624,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Giannakopoulos', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece. Electronic address: ggiannak@med.uoa.gr.'}, {'ForeName': 'Tytti', 'Initials': 'T', 'LastName': 'Solantaus', 'Affiliation': 'MIELI Mental Health Finland, Helsinki, Finland; Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Chara', 'Initials': 'C', 'LastName': 'Tzavara', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Kolaitis', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.070']
2902,32957604,Impact of Three-Year Intermittent Preventive Treatment Using Artemisinin-Based Combination Therapies on Malaria Morbidity in Malian Schoolchildren.,"Previous studies have shown that a single season of intermittent preventive treatment in schoolchildren (IPTsc) targeting the transmission season has reduced the rates of clinical malaria, all-cause clinic visits, asymptomatic parasitemia, and anemia. Efficacy over the course of multiple years of IPTsc has been scantly investigated.
METHODS
An open, randomized-controlled trial among schoolchildren aged 6-13 years was conducted from September 2007 to January 2010 in Kolle, Mali. Students were included in three arms: sulphadoxine-pyrimethamine+artesunate (SP+AS), amodiaquine+artesunate (AQ+AS), and control (C). All students received two full doses, given 2 months apart, and were compared with respect to the incidence of clinical malaria, all-cause clinic visits, asymptomatic parasitemia, and anemia.
RESULTS
A total of 296 students were randomized. All-cause clinic visits were in the SP+AS versus control (29 (20.1%) vs. 68 (47.2%); 20 (21.7%) vs. 41 (44.6%); and 14 (21.2%) vs. 30 (44.6%); p < 0.02) in 2007, 2008, and 2009, respectively. The prevalence of asymptomatic parasitemia was lower in the SP+AS compared to control (38 (7.5%) vs. 143 (28.7%); and 47 (12.7%) vs. 75 (21.2%); p < 0.002) in 2007 and 2008, respectively. Hemoglobin concentration was significantly higher in children receiving SP+AS (11.96, 12.06, and 12.62 g/dL) than in control children (11.60, 11.64, and 12.15 g/dL; p < 0.001) in 2007, 2008, and 2009, respectively. No impact on clinical malaria was observed.
CONCLUSION
IPTsc with SP+AS reduced the rates of all-cause clinic visits and anemia during a three-year implementation.",2020,"The prevalence of asymptomatic parasitemia was lower in the SP+AS compared to control (38 (7.5%) vs. 143 (28.7%); and 47 (12.7%) vs. 75 (21.2%); p < 0.002) in 2007 and 2008, respectively.","['schoolchildren aged 6-13 years was conducted from September 2007 to January 2010 in Kolle, Mali', 'A total of 296 students', 'Malian Schoolchildren']","['sulphadoxine-pyrimethamine+artesunate (SP+AS), amodiaquine+artesunate (AQ+AS), and control (C', 'Artemisinin-Based Combination Therapies']","['All-cause clinic visits', 'rates of all-cause clinic visits and anemia', 'Malaria Morbidity', 'Efficacy', 'prevalence of asymptomatic parasitemia', 'Hemoglobin concentration', 'clinical malaria']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0038679', 'cui_str': 'Sulfadoxine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}]",296.0,0.0715299,"The prevalence of asymptomatic parasitemia was lower in the SP+AS compared to control (38 (7.5%) vs. 143 (28.7%); and 47 (12.7%) vs. 75 (21.2%); p < 0.002) in 2007 and 2008, respectively.","[{'ForeName': 'Hamma', 'Initials': 'H', 'LastName': 'Maiga', 'Affiliation': 'Institut National de Santé Publique, Bamako 1771, Mali.'}, {'ForeName': 'Breanna', 'Initials': 'B', 'LastName': 'Barger', 'Affiliation': 'Spokane Emergency Physicians, Spokane, WA 99201, USA.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Guindo', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Oumar B', 'Initials': 'OB', 'LastName': 'Traore', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Mamadou', 'Initials': 'M', 'LastName': 'Tekete', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Dara', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Zoumana I', 'Initials': 'ZI', 'LastName': 'Traore', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Modibo', 'Initials': 'M', 'LastName': 'Diarra', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Samba', 'Initials': 'S', 'LastName': 'Coumare', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Aly', 'Initials': 'A', 'LastName': 'Kodio', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Ousmane B', 'Initials': 'OB', 'LastName': 'Toure', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Ogobara K', 'Initials': 'OK', 'LastName': 'Doumbo', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Abdoulaye A', 'Initials': 'AA', 'LastName': 'Djimde', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}]",Tropical medicine and infectious disease,['10.3390/tropicalmed5030148']
2903,32958699,Genomic Analysis of Germline Variation Associated with Survival of Patients with Colorectal Cancer Treated with Chemotherapy Plus Biologics in CALGB/SWOG 80405 (Alliance).,"PURPOSE
Irinotecan/5-fluorouracil (5-FU; FOLFIRI) or oxaliplatin/5-FU (FOLFOX), combined with bevacizumab or cetuximab, are approved, first-line treatments for metastatic colorectal cancer (mCRC). We aimed at identifying germline variants associated with survival in patients with mCRC treated with these regimens in Cancer and Leukemia Group B/SWOG 80405.
EXPERIMENTAL DESIGN
Patients with mCRC receiving either FOLFOX or FOLFIRI were randomized to either cetuximab or bevacizumab. DNA from peripheral blood was genotyped for approximately 700,000 SNPs. The association between SNPs and overall survival (OS) was tested in 613 patients of genetically estimated European ancestry using Cox proportional hazards models.
RESULTS
The four most significant SNPs associated with OS were three haplotypic SNPs between microsomal glutathione S-transferase 1 ( MGST1 ) and LIM domain only 3 ( LMO3 , representative HR, 1.56; P = 1.30 × 10 -6 ), and rs11644916 in AXIN1 (HR, 1.39, P = 4.26 × 10 -6 ). AXIN1 is a well-established tumor suppressor gene in colorectal cancer, and rs11644916 (G>A) conferred shorter OS. Median OS for patients with the AA, AG, or GG genotypes was 18.4, 25.6, or 36.4 months, respectively. In 90 patients with stage IV colorectal cancer from The Cancer Genome Atlas (TCGA), rs11649255 in AXIN1 [in almost complete linkage disequilibrium (LD) with rs11644916], was associated with shorter OS (HR, 2.24, P = 0.0096). Using rs11648673 in AXIN1 (in very high LD with rs11644916 and with functional evidence), luciferase activity in three colorectal cancer cell lines was reduced.
CONCLUSIONS
This is the first large genome-wide association study ever conducted in patients with mCRC treated with first-line standard treatment in a randomized phase III trial. A common SNP in AXIN1 conferred worse OS and the effect was replicated in TCGA. Further studies in colorectal cancer experimental models are required.",2020,"Median OS for patients with the AA, AG or GG genotypes was 18.4, 25.6, or 36.4 months, respectively.","['colorectal cancer patients treated with chemotherapy plus biologics in CALGB/SWOG 80405', 'metastatic colorectal cancer (mCRC', 'Patients with mCRC receiving either FOLFOX or FOLFIRI', '613 patients of genetically-estimated European ancestry using Cox proportional hazards models']","['Irinotecan/5-FU (FOLFIRI) or oxaliplatin/5-FU (FOLFOX), combined with bevacizumab or cetuximab', 'cetuximab or bevacizumab']","['shorter OS', 'SNPs and overall survival (OS', 'haplotypic SNPs between MGST1 and LMO3 (representative hazard ratios (HR', 'Median OS']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0010235', 'cui_str': 'Cox Proportional Hazards Models'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0360402,"Median OS for patients with the AA, AG or GG genotypes was 18.4, 25.6, or 36.4 months, respectively.","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. innocent@unc.edu.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Sibley', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Sushant A', 'Initials': 'SA', 'LastName': 'Patil', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Etheridge', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Alliance Statistics and Data Management Center, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Stefanie D', 'Initials': 'SD', 'LastName': 'Howell', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Plummer', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Casey', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Bertagnolli', 'Affiliation': ""Division of Surgical Oncology, Department of Surgery, Brigham & Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'McLeod', 'Affiliation': 'Taneja College of Pharmacy, University of South Florida, Tampa, Florida.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Auman', 'Affiliation': 'UNC Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': 'Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Furukawa', 'Affiliation': 'Division of Clinical Genome Research, Institute of Medical Science, the University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': 'Department of Medicine, University of California at San Francisco, San Francisco, California.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Kubo', 'Affiliation': 'Laboratory for Genotyping Development, Center for Integrative Medical Sciences, RIKEN, Tokyo, Japan.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Parker', 'Affiliation': 'UNC Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Ratain', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Kouros', 'Initials': 'K', 'LastName': 'Owzar', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, North Carolina.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2021']
2904,32965395,"Rationale and design of the ""Tocilizumab in patients with moderate to severe COVID-19: an open-label multicentre randomized controlled"" trial (TOCIBRAS).","INTRODUCTION
Pro-inflammatory markers play a significant role in the disease severity of patients with COVID-19. Thus, anti-inflammatory therapies are attractive agents for potentially combating the uncontrolled inflammatory cascade in these patients. We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19.
METHODS AND ANALYSIS
This open-label multicentre randomized controlled trial will compare clinical outcomes of tocilizumab plus standard of care versus standard of care alone in patients with moderate to severe COVID-19. Two of the following four criteria are required for protocol enrolment: D-dimer > 1,000ng/mL; C reactive protein > 5mg/dL, ferritin > 300mg/dL, and lactate dehydrogenase > upper limit of normal. The primary objective will be to compare the clinical status on day 15, as measured by a 7-point ordinal scale applied in COVID-19 trials worldwide. The primary endpoint will be assessed by an ordinal logistic regression assuming proportional odds ratios adjusted for stratification variables (age and sex).
ETHICS AND DISSEMINATION
The TOCIBRAS protocol was approved by local and central (national) ethical committees in Brazil following current national and international guidelines/directives. Each participating center had the study protocol approved by their institutional review boards before initiating protocol enrolment. The data derived from this trial will be published regardless of the results. If proven active, this strategy could alleviate the consequences of the inflammatory response in COVID-19 patients and improve their clinical outcomes.",2020,"We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19.
","['patients with moderate to severe COVID-19', 'patients with COVID-19', 'Each participating center had the study protocol approved by their institutional review boards before initiating protocol enrolment']","['tocilizumab', 'tocilizumab plus standard of care versus standard of care alone', 'Tocilizumab']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],,0.229721,"We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19.
","[{'ForeName': 'Danielle Leão Cordeiro de', 'Initials': 'DLC', 'LastName': 'Farias', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Prats', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Alexandre Biasi', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Regis Goulart', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Flávia Ribeiro', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Otávio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Organização de Pesquisa Acadêmica, Hospital Israelita Albert Einstein - São Paulo (SP), Brasil.'}, {'ForeName': 'Luciano César Pontes de', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Renato Delascio', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, Estados Unidos.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Avezum', 'Affiliation': 'Centro Internacional de Pesquisa, Hospital Alemão Oswaldo Cruz - São Paulo (SP), Brasil.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Kawano-Dourado', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Lucas Petri', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Salomón Soriano Ordinola', 'Initials': 'SSO', 'LastName': 'Rojas', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Cleyton Zanardo de', 'Initials': 'CZ', 'LastName': 'Oliveira', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Luis Eduardo Coelho', 'Initials': 'LEC', 'LastName': 'Andrade', 'Affiliation': 'Fleury Medicina e Laboratórios - São Paulo (SP), Brasil.'}, {'ForeName': 'Alex Freire', 'Initials': 'AF', 'LastName': 'Sandes', 'Affiliation': 'Fleury Medicina e Laboratórios - São Paulo (SP), Brasil.'}, {'ForeName': 'Maria Carolina', 'Initials': 'MC', 'LastName': 'Pintão', 'Affiliation': 'Fleury Medicina e Laboratórios - São Paulo (SP), Brasil.'}, {'ForeName': 'Claudio Galvão de', 'Initials': 'CG', 'LastName': 'Castro Júnior', 'Affiliation': 'Organização de Pesquisa Acadêmica, Hospital Israelita Albert Einstein - São Paulo (SP), Brasil.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Scheinberg', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Viviane Cordeiro', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}]",Revista Brasileira de terapia intensiva,['10.5935/0103-507X.20200060']
2905,32960955,Physiotherapy in addition to vacuum bell therapy in patients with pectus excavatum.,"OBJECTIVES
Vacuum bell and exercise therapy are non-invasive treatments for pectus excavatum (PE). The purpose of this study was to determine the effects of the physiotherapy programme applied in addition to vacuum bell treatment in patients with PE.
METHODS
The study included 26 male patients with PE aged 11-18 years. Patients were randomly divided into 2 groups: group 1 received only vacuum bell treatment; group 2 had vacuum bell therapy and physiotherapy. Patient demographic and disease-related characteristics, type of sternal depression, perception of their deformity, postural evaluations, treatment satisfaction and quality of life were evaluated before and 12 weeks after treatment.
RESULTS
From external chest circumference measurements related to PE, sternal depression and anthropometric index values showed improvement in both groups (P < 0.05), but better results were observed in group 2 than in group 1 (P < 0.05). Modified percent depth and scores from the T3 region (distance between the most prominent point of the sternum and the spinous process of the vertebra at the same level) showed improvement only in group 2 (P < 0.01), whereas severity of PE, the patient's perception of his deformity and parental physiological quality-of-life scores improved in both groups (P < 0.05). Posture, satisfaction with treatment and the patients' physiological quality-of-life scores were significantly better in group 2 (P < 0.05).
CONCLUSIONS
Due to the additional improvements and greater satisfaction in the group receiving physiotherapy, we think that a proper rehabilitation programme should be applied simultaneously with the vacuum bell treatment in patients with PE.
CLINICAL TRIAL REGISTRATION: CLINICALTRIALS.GOV
NCT04167865.",2020,"Posture, satisfaction with treatment and the patients' physiological quality-of-life scores were significantly better in group 2 (P < 0.05).
","['patients with PE', '26 male patients with PE aged 11-18\u2009years', 'patients with PE.\nMETHODS', 'patients with pectus excavatum']","['physiotherapy', 'Physiotherapy', 'vacuum bell treatment; group 2 had vacuum bell therapy and physiotherapy', 'physiotherapy programme', 'Vacuum bell and exercise therapy']","['Patient demographic and disease-related characteristics, type of sternal depression, perception of their deformity, postural evaluations, treatment satisfaction and quality of life', ""severity of PE, the patient's perception of his deformity and parental physiological quality-of-life scores"", 'PE, sternal depression and anthropometric index values', 'physiological quality-of-life scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016842', 'cui_str': 'Congenital pectus excavatum'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1699693', 'cui_str': 'Sternal depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0016842', 'cui_str': 'Congenital pectus excavatum'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",26.0,0.0613133,"Posture, satisfaction with treatment and the patients' physiological quality-of-life scores were significantly better in group 2 (P < 0.05).
","[{'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Alaca', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.'}, {'ForeName': 'Ihsan', 'Initials': 'I', 'LastName': 'Alaca', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Yüksel', 'Affiliation': 'Chest Wall Deformities and Pectus Association, Istanbul, Turkey.'}]",Interactive cardiovascular and thoracic surgery,['10.1093/icvts/ivaa161']
2906,32962406,The effect of pituitary adenylate cyclase-activating peptide-38 and vasoactive intestinal peptide in cluster headache.,"BACKGROUND
Previously reported increases in serum levels of vasodilating neuropeptides pituitary adenylate cyclase-activating peptide-38 (PACAP38) and vasoactive intestinal peptide (VIP) during attacks of cluster headache could indicate their involvement in cluster headache attack initiation. We investigated the attack-inducing effects of PACAP38 and vasoactive intestinal peptide in cluster headache, hypothesising that PACAP38, but not vasoactive intestinal peptide, would induce cluster-like attacks in episodic active phase and chronic cluster headache patients.
METHODS
In a double-blind crossover study, 14 episodic cluster headache patients in active phase, 15 episodic cluster headache patients in remission phase and 15 chronic cluster headache patients were randomly allocated to receive intravenous infusion of PACAP38 (10 pmol/kg/min) or vasoactive intestinal peptide (8 pmol/kg/min) over 20 min on two study days separated by at least 7 days. We recorded headache intensity, incidence of cluster-like attacks, cranial autonomic symptoms and vital signs using a questionnaire (0-90 min).
RESULTS
In episodic cluster headache active phase, PACAP38 induced cluster-like attacks in 6/14 patients and vasoactive intestinal peptide induced cluster-like attacks in 5/14 patients ( p = 1.000). In chronic cluster headache, PACAP38 and vasoactive intestinal peptide both induced cluster-like attacks in 7/15 patients ( p = 0.765). In episodic cluster headache remission phase, neither PACAP38 nor vasoactive intestinal peptide induced cluster-like attacks.
CONCLUSIONS
Contrary to our hypothesis, attack induction was lower than expected and roughly equal by PACAP38 and vasoactive intestinal peptide in episodic active phase and chronic cluster headache patients, which contradicts the PAC 1 -receptor as being solely responsible for attack induction. Trial registration: clinicaltrials.gov (identifier NCT03814226).",2020,"Contrary to our hypothesis, attack induction was lower than expected and roughly equal by PACAP38 and vasoactive intestinal peptide in episodic active phase and chronic cluster headache patients, which contradicts the PAC 1 -receptor as being solely responsible for attack induction.","['14 episodic cluster headache patients in active phase, 15 episodic cluster headache patients in remission phase and 15 chronic cluster headache patients', 'cluster headache']","['PACAP38 and vasoactive intestinal peptide', 'vasoactive intestinal peptide', 'intravenous infusion of PACAP38', 'pituitary adenylate cyclase-activating peptide-38 and vasoactive intestinal peptide']","['headache intensity, incidence of cluster-like attacks, cranial autonomic symptoms and vital signs using a questionnaire (0-90\u2009min']","[{'cui': 'C0393739', 'cui_str': 'Episodic cluster headache'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009088', 'cui_str': 'Cluster headache'}]","[{'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001492', 'cui_str': 'Adenylate cyclase'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0042395', 'cui_str': 'vasoactive intestinal peptide'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min'}]",14.0,0.083924,"Contrary to our hypothesis, attack induction was lower than expected and roughly equal by PACAP38 and vasoactive intestinal peptide in episodic active phase and chronic cluster headache patients, which contradicts the PAC 1 -receptor as being solely responsible for attack induction.","[{'ForeName': 'Anne Luise H', 'Initials': 'ALH', 'LastName': 'Vollesen', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Snoer', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Basit', 'Initials': 'B', 'LastName': 'Chaudhry', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anja Sofie', 'Initials': 'AS', 'LastName': 'Petersen', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hagedorn', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hoffmann', 'Affiliation': ""Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Rigmor H', 'Initials': 'RH', 'LastName': 'Jensen', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420940689']
2907,32962981,Cognitive Function Following Diabetic Ketoacidosis in Children With New-Onset or Previously Diagnosed Type 1 Diabetes.,"OBJECTIVE
This study assessed whether a single diabetic ketoacidosis (DKA) episode is associated with cognitive declines in children with newly diagnosed type 1 diabetes and whether the same is true in children who had previously been diagnosed after accounting for variations in glycemic control and other relevant factors.
RESEARCH DESIGN AND METHODS
We prospectively enrolled 758 children, 6-18 years old, who presented with DKA in a randomized multisite clinical trial evaluating intravenous fluid protocols for DKA treatment. DKA was moderate/severe in 430 children and mild in 328 children. A total of 392 children with DKA had new onset of type 1 diabetes, and the rest were previously diagnosed. Neurocognitive assessment occurred 2-6 months after the DKA episode. A comparison group of 376 children with type 1 diabetes, but no DKA exposure, was also enrolled.
RESULTS
Among all patients, moderate/severe DKA was associated with lower intelligence quotient (IQ) (β = -0.12, P < 0.001), item-color recall (β = -0.08, P = 0.010), and forward digit span (β = -0.06, P = 0.04). Among newly diagnosed patients, moderate/severe DKA was associated with lower item-color recall (β = -0.08, P = 0.04). Among previously diagnosed patients, repeated DKA exposure and higher HbA 1c were independently associated with lower IQ (β = -0.10 and β = -0.09, respectively, P < 0.01) and higher HbA 1c was associated with lower item-color recall (β = -0.10, P = 0.007) after hypoglycemia, diabetes duration, and socioeconomic status were accounted for.
CONCLUSIONS
A single DKA episode is associated with subtle memory declines soon after type 1 diabetes diagnosis. Sizable IQ declines are detectable in children with known diabetes, suggesting that DKA effects may be exacerbated in children with chronic exposure to hyperglycemia.",2020,"Among all patients, moderate/severe DKA was associated with lower intelligence quotient (IQ) (β = -0.12, P < 0.001), item-color recall (β = -0.08, P = 0.010), and forward digit span (β = -0.06, P = 0.04).","['children with newly diagnosed type 1 diabetes', 'children with chronic exposure to hyperglycemia', '430 children and mild in 328 children', '376 children with type 1 diabetes, but no DKA exposure, was also enrolled', 'children with known diabetes', 'Children With New-Onset or Previously Diagnosed Type 1 Diabetes', '392 children with DKA had new onset of type 1 diabetes, and the rest were previously diagnosed', 'We prospectively enrolled 758 children, 6-18 years old, who presented with DKA in a randomized multisite clinical trial evaluating intravenous fluid protocols for DKA treatment']",['DKA'],"['lower intelligence quotient (IQ', 'forward digit span', 'item-color recall', 'Cognitive Function', 'hypoglycemia, diabetes duration, and socioeconomic status', 'moderate/severe DKA', 'Neurocognitive assessment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}]","[{'cui': 'C0423903', 'cui_str': 'Low intelligence'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",758.0,0.0520046,"Among all patients, moderate/severe DKA was associated with lower intelligence quotient (IQ) (β = -0.12, P < 0.001), item-color recall (β = -0.08, P = 0.010), and forward digit span (β = -0.06, P = 0.04).","[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Ghetti', 'Affiliation': 'Department of Psychology, University of California, Davis, Davis, CA sghetti@ucdavis.edu.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Emergency Medicine, UC Davis Health, UC Davis School of Medicine, Sacramento, CA.'}, {'ForeName': 'Arleta', 'Initials': 'A', 'LastName': 'Rewers', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, University of Colorado Denver, Aurora, CO.""}, {'ForeName': 'Sage R', 'Initials': 'SR', 'LastName': 'Myers', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Jeff E', 'Initials': 'JE', 'LastName': 'Schunk', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Stoner', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH.""}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Garro', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, Rhode Island Hospital, The Warren Alpert Medical School, Brown University, Providence, RI.'}, {'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Quayle', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine in St. Louis, St. Louis, MO.""}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Brown', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's National Medical Center, The School of Medicine & Health Sciences, The George Washington University, Washington, DC.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Trainor', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Tzimenatos', 'Affiliation': 'Department of Emergency Medicine, UC Davis Health, UC Davis School of Medicine, Sacramento, CA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'DePiero', 'Affiliation': 'Division of Emergency Medicine, Nemours/Alfred I. duPont Hospital for Children, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'McManemy', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Texas Children's Hospital, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Lise E', 'Initials': 'LE', 'LastName': 'Nigrovic', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Maria Y', 'Initials': 'MY', 'LastName': 'Kwok', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, New York Presbyterian Morgan Stanley Children's Hospital, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY.""}, {'ForeName': 'Clinton S', 'Initials': 'CS', 'LastName': 'Perry', 'Affiliation': 'Center for Mind and Brain, University of California, Davis, Davis, CA.'}, {'ForeName': 'Cody S', 'Initials': 'CS', 'LastName': 'Olsen', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'T Charles', 'Initials': 'TC', 'LastName': 'Casper', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Nicole S', 'Initials': 'NS', 'LastName': 'Glaser', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-0187']
2908,32966563,Immediate Biochemical Changes After Gait Biofeedback in Individuals With Anterior Cruciate Ligament Reconstruction.,"CONTEXT
Gait biomechanics are linked to biochemical changes that contribute to the development of posttraumatic knee osteoarthritis in individuals with anterior cruciate ligament reconstruction (ACLR). It remains unknown if modifying peak loading during gait using real-time biofeedback will result in acute biochemical changes related to cartilage metabolism.
OBJECTIVE
To determine if acutely manipulating peak vertical ground reaction force (vGRF) during gait influences acute changes in serum cartilage oligomeric matrix protein concentration (sCOMP) among individuals with ACLR.
DESIGN
Crossover study.
PATIENTS OR OTHER PARTICIPANTS
Thirty individuals with unilateral ACLR participated (70% female, age = 20.43 ± 2.91 years old, body mass index = 24.42 ± 4.25, months post-ACLR = 47.83 ± 26.97). Additionally, we identified a subgroup of participants who demonstrated an increase in sCOMP after the control or natural loading condition (sCOMPCHANGE > 0 ng/mL, n = 22, 70% female, age = 20.32 ± 3.00 years old, body mass index = 24.73 ± 4.33, months post-ACLR = 47.27 ± 29.32).
MAIN OUTCOME MEASURE(S)
Serum was collected both prior to and immediately after each condition to determine sCOMPchange.
INTERVENTION(S)
All participants attended 4 sessions that involved 20 minutes of walking on a force-measuring treadmill consisting of a control condition (natural loading) followed by random ordering of 3 loading conditions with real-time biofeedback: (1) symmetric vGRF between limbs, (2) a 5% increase in vGRF (high loading) and (3) a 5% decrease in vGRF (low loading). A general linear mixed model was used to determine differences in sCOMPCHANGE between altered loading conditions and the control group in the entire cohort and the subgroup.
RESULTS
The sCOMPCHANGE was not different across loading conditions for the entire cohort (F3,29 = 1.34, P = .282). Within the subgroup, sCOMPCHANGE was less during high loading (1.95 ± 24.22 ng/mL, t21 = -3.53, P = .005) and symmetric loading (9.93 ± 21.45 ng/mL, t21 = -2.86, P = .025) compared with the control condition (25.79 ± 21.40 ng/mL).
CONCLUSIONS
Increasing peak vGRF during gait decreased sCOMP in individuals with ACLR who naturally demonstrated an increase in sCOMP after 20 minutes of walking.
TRIAL REGISTRY
ClinicalTrials.gov (NCT03035994).",2020,"The sCOMPCHANGE was not different across loading conditions for the entire cohort (F3,29 = 1.34, P = .282).","['Individuals With Anterior Cruciate Ligament Reconstruction', 'individuals with anterior cruciate ligament reconstruction (ACLR', 'Thirty individuals with unilateral ACLR participated (70% female, age = 20.43 ± 2.91 years old, body mass index = 24.42 ± 4.25, months post-ACLR = 47.83 ± 26.97', 'individuals with ACLR', 'after the control or natural loading condition (sCOMPCHANGE > 0 ng/mL, n = 22, 70% female, age = 20.32 ± 3.00 years old, body mass index = 24.73 ± 4.33, months post-ACLR = 47.27 ± 29.32']","['Gait Biofeedback', 'walking on a force-measuring treadmill consisting of a control condition (natural loading) followed by random ordering of 3 loading conditions with real-time biofeedback: (1) symmetric vGRF']","['symmetric loading', 'sCOMP', 'Immediate Biochemical Changes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]","[{'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0601900', 'cui_str': 'COMP (Cartilage Oligomeric Matrix Protein)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",30.0,0.0605497,"The sCOMPCHANGE was not different across loading conditions for the entire cohort (F3,29 = 1.34, P = .282).","[{'ForeName': 'Brittney A', 'Initials': 'BA', 'LastName': 'Luc-Harkey', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Franz', 'Affiliation': 'Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, Raleigh.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Hackney', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill.'}, {'ForeName': 'J Troy', 'Initials': 'JT', 'LastName': 'Blackburn', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Darin A', 'Initials': 'DA', 'LastName': 'Padua', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Schwartz', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Davis-Wilson', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Spang', 'Affiliation': 'Department of Orthopaedics, MOTION Science Institute, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pietrosimone', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill.'}]",Journal of athletic training,['10.4085/1062-6050-0372.19']
2909,32966568,A Social-Marketing Intervention and Concussion-Reporting Beliefs.,"CONTEXT
Concussion-symptom education remains the primary approach used by athletic trainers to address underreporting of possible sport-related concussions. Social marketing represents an untapped approach to promote concussion reporting by communicating the benefits or consequences of reporting or not reporting, respectively.
OBJECTIVE
To apply expectancy value theory and identify how marketing the possible consequences of concealing concussion symptoms influenced young adults' concussion-reporting beliefs to increase the likelihood of reporting.
DESIGN
Randomized controlled clinical trial.
SETTING
Laboratory.
PATIENTS OR OTHER PARTICIPANTS
A total of 468 competitive collegiate club sport athletes at a large US university who engaged in 1 of 46 sports with various levels of concussion risk.
INTERVENTION(S)
Participants were randomly assigned by team to 1 of 3 conditions. The treatment condition was a social-marketing program focused on the possible consequences of the reporting decision. The control condition was traditional concussion-symptom education based on the National Collegiate Athletic Association's publication, ""Concussion: A Fact Sheet for Student-Athletes."" An additional condition mirrored the traditional symptom education but included a less clinical delivery.
MAIN OUTCOME MEASURE(S)
Positive and negative beliefs regarding concussion reporting were assessed. We applied expectancy value theory, which posits that changing beliefs in the short term will produce greater reporting intentions in the long term.
RESULTS
Club sport athletes exposed to consequence-based social marketing showed higher levels of positive reporting beliefs and lower levels of negative reporting beliefs than athletes exposed to traditional or revised symptom education. We observed no differences between the traditional and revised symptom-education programs. Exposure to consequence-based marketing decreased negative beliefs about reporting (B = -0.165, P = .01) and increased positive beliefs about reporting (B = 0.165, P = .01).
CONCLUSIONS
Social marketing offers athletic trainers another strategic tool for motivating athletes to report concussion symptoms by translating scientific findings into marketable statements and then communicating the benefits of reporting or the negative consequences of concealing concussion symptoms.",2020,"Exposure to consequence-based marketing decreased negative beliefs about reporting (B = -0.165, P = .01) and increased positive beliefs about reporting (B = 0.165, P = .01).
","['Student-Athletes', '468 competitive collegiate club sport athletes at a large US university who engaged in 1 of 46 sports with various levels of concussion risk']",['Concussion'],['positive reporting beliefs and lower levels of negative reporting beliefs'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",468.0,0.0262032,"Exposure to consequence-based marketing decreased negative beliefs about reporting (B = -0.165, P = .01) and increased positive beliefs about reporting (B = 0.165, P = .01).
","[{'ForeName': 'Dee', 'Initials': 'D', 'LastName': 'Warmath', 'Affiliation': 'Department of Financial Planning, Housing, and Consumer Economics, College of Family and Consumer Sciences, University of Georgia, Athens.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Winterstein', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Madison.'}]",Journal of athletic training,['10.4085/1062-6050-242-19']
2910,32966959,Within-person networks of clinical features of social anxiety disorder during cognitive and interpersonal therapy.,"Analysis of longitudinal within-person networks over the course of therapy allows an identification of possible targets of treatment. This study examined within-person networks of clinical features in social anxiety disorder (SAD) patients during cognitive (CT) and interpersonal (IPT) therapy. Patients (n = 80) were randomized to either CT or IPT in a 10 week residential program. They completed a measure of clinical features two times a week. The 60 (75 %) patients who had completed at least 18 measurements were included in the analyses. The multilevel vector autoregressive (mlVAR) model was used to analyze the data, producing a temporal, contemporaneous, and between-person network. In the temporal network and as expected, more homework compliance in a half-week predicted less social anxiety and less social avoidance the subsequent half-week. Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus. Unexpectedly, less social avoidance predicted more self-focus and less self-focus predicted less social function and social joy. In the contemporaneous network, self-focus, anxiety and avoidance displayed a conditional independence structure. The estimated temporal network suggests that homework compliance and social function are promising targets of treatment.",2020,"Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus.","['social anxiety disorder (SAD) patients during cognitive (CT) and interpersonal (IPT) therapy', 'The 60 (75 %) patients who had completed at least 18 measurements were included in the analyses', 'Patients (n = 80']","['cognitive and interpersonal therapy', 'CT or IPT']","['social function and social joy', 'social anxiety', 'social avoidance', 'homework compliance']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",80.0,0.0147056,"Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus.","[{'ForeName': 'Asle', 'Initials': 'A', 'LastName': 'Hoffart', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Badeveien 287, N-3370, Vikersund, Norway; Department of Psychology, University of Oslo, PB 1094, Blindern, N-0317, Oslo, Norway. Electronic address: asle.hoffart@modum-bad.no.'}, {'ForeName': 'Sverre Urnes', 'Initials': 'SU', 'LastName': 'Johnson', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Badeveien 287, N-3370, Vikersund, Norway; Department of Psychology, University of Oslo, PB 1094, Blindern, N-0317, Oslo, Norway. Electronic address: Sverre.Johnson@modum-bad.no.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102312']
2911,32969197,Weight Reduction Through a Cognitive Behavioral Therapy Lifestyle Intervention in PCOS: The Primary Outcome of a Randomized Controlled Trial.,"OBJECTIVE
Long-term weight loss is important and difficult to achieve for many women with polycystic ovary syndrome (PCOS). Lifestyle interventions (LS) in PCOS have shown moderate short-term effects. Three-component LS that combine nutrition advice, exercise, and cognitive behavioral therapy have not been tested in long-term interventions.
METHODS
Women (N = 183) with PCOS who were trying to conceive and had BMI > 25 kg/m 2 were assigned to 20 group sessions of cognitive behavioral therapy combined with nutrition advice and exercise (LS with or without Short Message Service [SMS] via mobile phone) or care as usual (CAU).
RESULTS
More weight loss was observed in LS than in CAU (P < 0.001). Adding SMS was even more effective (P = 0.017). In CAU, 13 of 60 (21.8%) succeeded in achieving a 5% weight loss, as did 32 of 60 (52.8%) in LS without SMS and 54 of 63 (85.7%) in LS with SMS. The odds of achieving a 5% weight loss were 7.0 (P < 0.001) in LS compared with CAU. More than 18 of 60 (29.0%) of the women in CAU gained weight versus 5 of 60 (8.5%) and 2 of 63 (3.1%) in LS without or with SMS, respectively. The overall dropout rate was 116 of 183 (63.4%).
CONCLUSIONS
A three-component LS program resulted in reasonable weight loss in women with PCOS. Adding SMS resulted in more weight loss.",2020,The odds of achieving a 5% weight loss were 7.0 (P < 0.001) in LS compared with CAU.,"['Women (N\u2009=\u2009183) with PCOS who were trying to conceive and had BMI\u2009>\u200925 kg/m 2', 'PCOS', 'women with polycystic ovary syndrome (PCOS', 'women with PCOS']","['SMS', 'cognitive behavioral therapy combined with nutrition advice and exercise (LS with or without Short Message Service [SMS] via mobile phone) or care as usual (CAU', 'Lifestyle interventions (LS', 'Cognitive Behavioral Therapy Lifestyle Intervention']","['weight loss', 'overall dropout rate', 'odds of achieving a 5% weight loss', 'Weight Reduction', 'reasonable weight loss']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0420843', 'cui_str': 'Trying to conceive'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0444892', 'cui_str': 'CAU'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",183.0,0.128628,The odds of achieving a 5% weight loss were 7.0 (P < 0.001) in LS compared with CAU.,"[{'ForeName': 'Geranne', 'Initials': 'G', 'LastName': 'Jiskoot', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Timman', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Annemerle', 'Initials': 'A', 'LastName': 'Beerthuizen', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Dietz de Loos', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Busschbach', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'Laven', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, the Netherlands.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22980']
2912,32975829,Portable gluten sensors: qualitative assessments by adults and adolescents with coeliac disease.,"BACKGROUND
Portable gluten sensors are now commercially available to the public, although there is genuine uncertainty within the medical community over whether they should be used for coeliac disease management. The present study described qualitatively the experience of using a portable gluten sensor for 15 adults and 15 adolescents with coeliac disease participating in a 3-month pilot clinical trial.
METHODS
Participants were 30 individuals, aged 13-70 years, with biopsy-confirmed coeliac disease on a gluten-free diet. All received a portable gluten sensor and were randomised to low, medium, and high numbers of single-use capsules. Open-ended questions addressed likes and dislikes using the portable gluten sensor after 3 months. Major themes were identified and described.
RESULTS
Participants liked that the portable gluten sensor provided extra assurance to check foods presented as gluten-free, the convenient size and portability, the added sense of control, and overall peace-of-mind. Participants disliked having attention drawn to them when using the sensor and feeling as if they were deterring others from eating. Participants also disliked the physical difficulty associated with using the capsules, questionable accuracy and the inability to test fermented foods. Adults were more enthusiastic about the sensor than adolescents.
CONCLUSIONS
Positive and negative experiences may be expected when using commercially available portable gluten sensors to help manage coeliac disease. As future versions of this and other gluten sensors become available, it will be important to investigate the relationship between users' experience with the sensors and long-term outcomes such as mucosal healing and quality of life.",2020,"RESULTS
Participants liked that the portable gluten sensor provided extra assurance to check foods presented as gluten-free, the convenient size and portability, the added sense of control, and overall peace-of-mind.","['15 adults and 15 adolescents with coeliac disease participating in a 3-month pilot clinical trial', 'adults and adolescents with coeliac disease', 'Participants were 30 individuals, aged 13-70\xa0years, with biopsy-confirmed coeliac disease on a gluten-free diet']",['portable gluten sensor'],['mucosal healing and quality of life'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}]","[{'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]","[{'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",15.0,0.0266346,"RESULTS
Participants liked that the portable gluten sensor provided extra assurance to check foods presented as gluten-free, the convenient size and portability, the added sense of control, and overall peace-of-mind.","[{'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Wolf', 'Affiliation': 'Department of Health & Behavior Studies, Program in Nutrition, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vipperman-Cohen', 'Affiliation': 'Department of Health & Behavior Studies, Program in Nutrition, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'P H R', 'Initials': 'PHR', 'LastName': 'Green', 'Affiliation': 'Department of Medicine, Celiac Disease Center, Columbia University Irving Medical Center, Harkness Pavilion, New York, NY, USA.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Celiac Disease Center, Columbia University Irving Medical Center, Harkness Pavilion, New York, NY, USA.'}, {'ForeName': 'N R', 'Initials': 'NR', 'LastName': 'Reilly', 'Affiliation': 'Department of Medicine, Celiac Disease Center, Columbia University Irving Medical Center, Harkness Pavilion, New York, NY, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zybert', 'Affiliation': 'Department of Health & Behavior Studies, Program in Nutrition, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lebwohl', 'Affiliation': 'Department of Medicine, Celiac Disease Center, Columbia University Irving Medical Center, Harkness Pavilion, New York, NY, USA.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12810']
2913,32987346,The effects of McConnell patellofemoral joint and tibial internal rotation limitation taping techniques in people with Patellofemoral pain syndrome.,"BACKGROUND
Taping is frequently used as part of the multi-modal management for patellofemoral pain syndrome (PFPS). McConnell Patellofemoral Joint Taping (PFJT) and Tibial Internal Rotation Limitation Taping (TIRLT) are proposed to be useful adjuncts to the management of PFPS. However, it is unclear if TIRLT offers similar benefits to PFJT, and its effect on pain and lower limb kinematics have not been investigated previously.
RESEARCH QUESTION
What are the effects of TIRLT, PFJT and no taping on perceived pain and lower limb kinematics during a lunge and single leg squat (SLS) in people with PFPS?
METHODS
This cross-sectional study compared the effects of TIRLT, PFJT and no taping, on knee pain and lower limb kinematics during two pain-provoking movements in people with PFPS. Participants with PFPS (n = 23) performed a lunge and SLS under three randomised conditions: TIRLT, PFJT and no taping. The Codamotion system captured and analysed lower limb kinematic data in the sagittal, transverse and coronal planes. Peak knee pain intensity during the movement was assessed using the Numerical Rating Scale (NRS).
RESULTS
Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively). There was no evidence of altered lower limb kinematics accompanying pain reductions with either taping technique.
SIGNIFICANCE
Both forms of taping may be useful adjuncts as the short-term benefit of pain relief may enable participation in more active forms of rehabilitation.",2020,"RESULTS
Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively).","['people with PFPS', 'Participants with PFPS (n = 23) performed a lunge and SLS under three randomised conditions', 'people with Patellofemoral pain syndrome', 'patellofemoral pain syndrome (PFPS']","['McConnell Patellofemoral Joint Taping (PFJT) and Tibial Internal Rotation Limitation Taping (TIRLT', 'TIRLT, PFJT and no taping', 'McConnell patellofemoral joint and tibial internal rotation limitation taping techniques']","['Numerical Rating Scale (NRS', 'pain', 'Peak knee pain intensity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral pain syndrome'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0447801', 'cui_str': 'Structure of patellofemoral joint'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",23.0,0.053827,"RESULTS
Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively).","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Clifford', 'Affiliation': 'School of Allied Health and Health Research Institute, University of Limerick, Limerick, Ireland. Electronic address: Amanda.clifford@ul.ie.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dillon', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin 9, Ireland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hartigan', 'Affiliation': 'School of Allied Health, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': ""O'Leary"", 'Affiliation': 'Physiotherapy Department, University Hospital Kerry, Kerry, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Constantinou', 'Affiliation': 'School of Allied Health, Faculty of Health Sciences, Australian Catholic University, Brisbane, Queensland, Australia.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.010']
2914,32987771,"Guideline-Based Statin Eligibility, Coronary Artery Stenosis and Cardiovascular Events in Patients with Stable Chest Pain: A Secondary Analysis of the PROMISE Randomized Clinical Trial.","BACKGROUND
Recommendations for preventive statin treatment in patients with stable chest pain may be difficult as symptoms can be unspecific. It is unclear if coronary CT angiography (CTA)-detected coronary artery disease (CAD) can optimize statin prescription.
METHODS
In stable chest pain patients randomized to CTA in the PROMISE trial, statin eligibility was defined per 2018 American College of Cardiology/American Heart Association (ACC/AHA) guidelines. Primary outcome was a composite of death, myocardial infarction or unstable angina over 26 months median follow-up. Hazard ratios (HR) of non-obstructive (1-69% stenosis) and obstructive (≥70% stenosis) CAD for events were determined using Cox proportional hazard models. Calculated HR were then incorporated into the ACC/AHA pooled cohort equation (PCE) to revised ASCVD risk and assess re-classification of statin eligibility.
RESULTS
Among 3986 patients (60.5 ± 8.2 years; 51% female), 72.9% (2904/3986) were statin eligible. Event rates in statin-eligible vs. ineligible patients were 3.3% vs. 2.3% (HR = 1.4 (95% CI 0.9-2.2), p = 0.142). Although the proportion of statin-eligible patients increased with CAD severity, 54% without CAD were statin eligible. Incorporating information on CAD into PCE reclassified 12.7% of patients (1.3% towards statin, 11.4% towards no statin). Similar results were found in stratified analysis of statin naïve patients (reclassification of 13.9%, 1.0% towards statin, and 12.9% towards no statin). As a result, revised ASCVD risk improved model discrimination in all patients (c-statistic: 0.59 (95 %CI 0.55-0.62) vs. 0.52 (95 %CI 0.49-0.56); p 0.001), while reducing statin use by 10.1% (62.7% vs. 72.9% statin eligible, p 0.001).
CONCLUSION
In stable chest pain patients, integration of CAD into guideline recommendations was associated with greater accuracy to reclassify those at increased risk for incident events and a more efficient use of statins.",2020,"Event rates in statin-eligible vs. ineligible patients were 3.3% vs. 2.3% (HR = 1.4 (95% CI 0.9-2.2), p = 0.142).","['Patients with Stable Chest Pain', '3986 patients (60.5 ± 8.2 years; 51% female), 72.9% (2904/3986) were statin eligible', '2018 American College of Cardiology/American Heart Association (ACC/AHA) guidelines', 'patients with stable chest pain', 'stable chest pain patients']","['CTA', 'coronary CT angiography (CTA)-detected coronary artery disease (CAD']","['Hazard ratios (HR) of non-obstructive', 'composite of death, myocardial infarction or unstable angina over 26 months median follow-up', 'revised ASCVD risk improved model discrimination']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0050451', 'cui_str': 'acetohydroxamic acid'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]",3986.0,0.0851533,"Event rates in statin-eligible vs. ineligible patients were 3.3% vs. 2.3% (HR = 1.4 (95% CI 0.9-2.2), p = 0.142).","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Pursnani', 'Affiliation': 'Cardiology Division, NorthShore University Health System, Evanston, IL 60201, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Taron', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mayrhofer', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Lu', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.'}, {'ForeName': 'Maros', 'Initials': 'M', 'LastName': 'Ferencik', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health and Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Ladapo', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at UCLA, Los Angeles, CA 90024, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 27708, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.'}]",Journal of clinical medicine,['10.3390/jcm9103076']
2915,32970697,"Acceptability of a trial of vaginal progesterone for the prevention of preterm birth among HIV-infected women in Lusaka, Zambia: A mixed methods study.","Antenatal progesterone prevents preterm birth (PTB) in women with a short cervix or prior PTB in daily vaginal or weekly injectable formulations, respectively. Neither has been tested for the indication of maternal HIV, which is associated with an elevated risk of PTB. The Vaginal Progesterone (VP) Trial was a pilot feasibility study of VP to prevent HIV-related PTB in Lusaka, Zambia. Using mixed methods, we concurrently evaluated the acceptability of the trial and the study product among participants. Over a 1-year period, we enrolled 140 pregnant women living with HIV into a double-masked, placebo-controlled, randomized trial of daily self-administered VP or placebo. We administered an endline questionnaire to all participants and conducted in-depth interviews with 30 participants to assess barriers and facilitators to uptake and retention in the trial and to study product adherence. All interviews were audiotaped, transcribed, translated into English as needed, and independently coded by two analysts to capture emerging themes. Of 131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product. When given a hypothetical choice between vaginal and injectable progesterone, 97 (74%) chose vaginal, 31 (24%) injectable, and 3 (2%) stated no preference. Most interviewees reported no difficulties with using the study product; others cited minor side effects and surmountable challenges. Strategies that supported adherence included setting alarms, aligning dosing with antiretrovirals, receiving encouragement from friends and family, sensing a benefit to their unborn baby, and positive feedback from study staff. Participants who reported preference of a vaginal medication over injectable described familiarity with the vaginal product, a fear of needles and resulting pain, and inconvenience of a weekly clinic visit. Those who would prefer weekly injections cited fewer doses to remember. Perceived barriers to study participation included mistrust about the motivations behind research, suspicion of Satanism, and futility or possible harm from a placebo. We report key influences on acceptability of a randomized trial of VP to prevent PTB among HIV-infected women in Zambia, which should inform methods to promote uptake, adherence, and retention in a full-scale trial.",2020,"Of 131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product.","['women with a short cervix or prior PTB in daily vaginal or weekly injectable formulations, respectively', '140 pregnant women living with HIV into a double-masked', 'preterm birth among HIV-infected women in Lusaka, Zambia', '131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product', 'Participants who reported preference of a vaginal medication over injectable described familiarity with the vaginal product, a fear of needles and resulting pain, and inconvenience of a weekly clinic visit', 'HIV-infected women in Zambia']","['vaginal progesterone', 'Antenatal progesterone', 'placebo', 'VP', 'daily self-administered VP or placebo']",['preterm birth (PTB'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C3205661', 'cui_str': 'Vaginal Product'}, {'cui': 'C0424187', 'cui_str': 'Fear of needles'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]",140.0,0.29868,"Of 131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product.","[{'ForeName': 'Joan T', 'Initials': 'JT', 'LastName': 'Price', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.""}, {'ForeName': 'Chileshe M', 'Initials': 'CM', 'LastName': 'Mabula-Bwalya', 'Affiliation': 'UNC Global Projects - Zambia, Lusaka, Zambia.'}, {'ForeName': 'Bethany L', 'Initials': 'BL', 'LastName': 'Freeman', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Carda-Auten', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Winifreda M', 'Initials': 'WM', 'LastName': 'Phiri', 'Affiliation': 'UNC Global Projects - Zambia, Lusaka, Zambia.'}, {'ForeName': 'Kasapo', 'Initials': 'K', 'LastName': 'Chibwe', 'Affiliation': 'UNC Global Projects - Zambia, Lusaka, Zambia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Kantumoya', 'Affiliation': 'UNC Global Projects - Zambia, Lusaka, Zambia.'}, {'ForeName': 'Bellington', 'Initials': 'B', 'LastName': 'Vwalika', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Jeffrey S A', 'Initials': 'JSA', 'LastName': 'Stringer', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.""}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Golin', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}]",PloS one,['10.1371/journal.pone.0238748']
2916,32970730,"Test but not treat: Community members' experiences with barriers and facilitators to universal antiretroviral therapy uptake in rural KwaZulu-Natal, South Africa.","INTRODUCTION
Antiretroviral therapy (ART) has revolutionised the care of HIV-positive individuals resulting in marked decreases in morbidity and mortality, and markedly reduced transmission to sexual partners. However, these benefits can only be realised if individuals are aware of their HIV-positive status, initiated and retained on suppressive lifelong ART. Framed using the socio-ecological model, the present study explores factors contributing to poor ART uptake among community members despite high acceptance of HIV-testing within a Treatment as Prevention (TasP) trial. In this paper we identify barriers and facilitators to treatment across different levels of the socio-ecological framework covering individual, community and health system components.
METHODS
This research was embedded within a cluster-randomised trial (ClinicalTrials.gov, number NCT01509508) of HIV treatment as Prevention in rural KwaZulu-Natal, South Africa. Data were collected between January 2013 and July 2014 from resident community members. Ten participants contributed to repeat in-depth interviews whilst 42 participants took part in repeat focus group discussions. Data from individual interviews and focus group discussions were triangulated using community walks to give insights into community members' perception of the barriers and facilitators of ART uptake. We used thematic analysis guided by a socio-ecological framework to analyse participants' narratives from both individual interviews and focus group discussions.
RESULTS
Barriers and facilitators operating at the individual, community and health system levels influence ART uptake. Stigma was an over-arching barrier, across all three levels and expressed variably as fear of HIV disclosure, concerns about segregated HIV clinical services and negative community religious perceptions. Other barriers were individual (substance misuse, fear of ART side effects), community (alternative health beliefs). Facilitators cited by participants included individual (expectations of improved health and longer life expectancy following ART, single tablet regimens), community (availability of ART in the community through mobile trial facilities) and health system factors (fast and efficient service provided by friendly staff).
DISCUSSION
We identified multiple barriers to achieving universal ART uptake. To enhance uptake in HIV care services, and achieve the full benefits of ART requires interventions that tackle persistent HIV stigma, and offer people with HIV respectful, convenient and efficient services. These interventions require evaluation in appropriately designed studies.",2020,"Stigma was an over-arching barrier, across all three levels and expressed variably as fear of HIV disclosure, concerns about segregated HIV clinical services and negative community religious perceptions.","['Data were collected between January 2013 and July 2014 from resident community members', 'rural KwaZulu-Natal, South Africa']",['Antiretroviral therapy (ART'],['morbidity and mortality'],"[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",42.0,0.134278,"Stigma was an over-arching barrier, across all three levels and expressed variably as fear of HIV disclosure, concerns about segregated HIV clinical services and negative community religious perceptions.","[{'ForeName': 'Collins', 'Initials': 'C', 'LastName': 'Iwuji', 'Affiliation': 'Department of Global Health and Infection, Brighton and Sussex Medical School, University of Sussex, Falmer, United Kingdom.'}, {'ForeName': 'Rujeko Samanthia', 'Initials': 'RS', 'LastName': 'Chimukuche', 'Affiliation': 'Africa Health Research Institute, Berea, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Thembelihle', 'Initials': 'T', 'LastName': 'Zuma', 'Affiliation': 'Africa Health Research Institute, Berea, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Plazy', 'Affiliation': 'Univ. Bordeaux, Inserm, Bordeaux Population Health Research Center, Bordeaux, France.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Larmarange', 'Affiliation': 'Institut de Recherche pour le Développement(IRD), Centre Population et Développement (Ceped), Paris, France.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Orne-Gliemann', 'Affiliation': 'Univ. Bordeaux, Inserm, Bordeaux Population Health Research Center, Bordeaux, France.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Siedner', 'Affiliation': 'Africa Health Research Institute, Berea, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shahmanesh', 'Affiliation': 'Africa Health Research Institute, Berea, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'Africa Health Research Institute, Berea, KwaZulu-Natal, South Africa.'}]",PloS one,['10.1371/journal.pone.0239513']
2917,32970784,A randomised trial of social support group intervention for people with aphasia: A Novel application of virtual reality.,"About a third of strokes cause aphasia, or language loss, with profound consequences for the person's social participation and quality of life. These problems may be mitigated by group social support. But this intervention is not available to all individuals. This study investigated whether it is feasible to deliver group social support to people with aphasia via a multi-user, virtual reality platform. It also explored the indicative effects of intervention and the costs. Intervention aimed to promote wellbeing and communicative success. It enabled participants to form new social connections and share experiences of living with aphasia. It comprised 14 sessions delivered over 6 months and was led by community based co-ordinators and volunteers. Feasibility measures comprised: recruitment and retention rates, compliance with intervention and assessment of treatment fidelity. Effects of intervention were explored using a waitlist randomised controlled design, with outcome measures of wellbeing, communication, social connectedness and quality of life. Two intervention groups were randomised to an immediate condition and two were randomised to a delayed condition. The main analysis explored scores on the measures between two time points, between which those in the immediate condition had received intervention, but those in the delayed group had not (yet). A comprehensive approach to economic data collection ensured that all costs of treatment delivery were recorded. Feasibility findings showed that the recruitment target was met (N = 34) and 85.3% (29/34) of participants completed intervention. All groups ran the 14 sessions as planned, and participants attended a mean of 11.4 sessions (s.d. 2.8), which was 81.6% of the intended dose. Fidelity checking showed minimal drift from the manualised intervention. No significant change was observed on any of the outcome measures, although the study was not powered to detect these. Costs varied across the four groups, from £7,483 - £12,562 British Pounds Sterling ($10,972 - $18,419 US dollars), depending on travel costs, the relative contributions of volunteers and the number of hardware loans that were needed. The results suggest that a larger trial of remote group support, using virtual reality, would be merited. However the treatment content and regime, and the selection of outcome measures should be reviewed before conducting the trial. Trail registration: Study registered with ClinicalTrials.gov; Identifier: https://www.ncbi.nlm.nih.gov/NCT03115268.",2020,"Costs varied across the four groups, from £7,483 - £12,562 British Pounds Sterling ($10,972 - $18,419 US dollars), depending on travel costs, the relative contributions of volunteers and the number of hardware loans that were needed.",['people with aphasia'],['social support group intervention'],"['recruitment and retention rates, compliance with intervention and assessment of treatment fidelity', 'wellbeing, communication, social connectedness and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}]","[{'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0650251,"Costs varied across the four groups, from £7,483 - £12,562 British Pounds Sterling ($10,972 - $18,419 US dollars), depending on travel costs, the relative contributions of volunteers and the number of hardware loans that were needed.","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Devane', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Talbot', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Caute', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Cruice', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Hilari', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'MacKenzie', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Maguire', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Anita Patel Health Economics Consulting Ltd, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Abi', 'Initials': 'A', 'LastName': 'Roper', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Wilson', 'Affiliation': 'Centre for Human Computer Interaction Design, City, University of London, London, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0239715']
2918,32971277,Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial.,"BACKGROUND
Persistent poorly-controlled type 2 diabetes mellitus (PPDM), or maintenance of a hemoglobin A1c (HbA1c) ≥8.5% despite receiving clinic-based diabetes care, contributes disproportionately to the national diabetes burden. Comprehensive telehealth interventions may help ameliorate PPDM, but existing approaches have rarely been designed with clinical implementation in mind, limiting use in routine practice. We describe a study testing a novel telehealth intervention that comprehensively targets clinic-refractory PPDM, and was explicitly developed for practical delivery using existing Veterans Health Administration (VHA) clinical infrastructure.
METHODS
Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management. The primary outcome is HbA1c. Secondary outcomes include diabetes distress, self-care, self-efficacy, weight, depressive symptoms, implementation barriers/facilitators, and costs. We hypothesize that the PRACTICE-DM intervention will reduce HbA1c by >0.6% versus standard HT over 12 months.
RESULTS
Enrollment for this ongoing trial concluded in January 2020; 200 patients were randomized (99 to standard HT and 101 to the PRACTICE-DM intervention). The cohort has a mean age of 58 and is 23% female and 72% African American. Mean baseline HbA1c and BMI were 10.2% and 34.8 kg/m 2 .
CONCLUSIONS
Because it comprehensively targets factors underlying PPDM using existing clinical infrastructure, the PRACTICE-DM intervention may be well suited to lower the complications and costs of PPDM in routine practice.",2020,"Methods Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management.","['mean age of 58 and is 23% female and 72% African American', 'Patients with Clinic-Refractory Diabetes Mellitus', 'January 2020; 200 patients', 'patients with clinic-refractory diabetes mellitus (PRACTICE-DM']","['comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management', 'standard VHA Home Telehealth (HT) telemonitoring/care coordination']","['diabetes distress, self-care, self-efficacy, weight, depressive symptoms, implementation barriers/facilitators, and costs', 'Mean baseline HbA1c and BMI']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0618884', 'cui_str': 'IS 23'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",200.0,0.0844592,"Methods Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Kobe', 'Affiliation': 'Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edelman', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Phillip E', 'Initials': 'PE', 'LastName': 'Tarkington', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Maciejewski', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steinhauser', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Jeffreys', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Smith', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Strawbridge', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Steven T', 'Initials': 'ST', 'LastName': 'Szabo', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, NC, United States of America; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States of America; VA Mid-Atlantic Mental Illness, Research, Education and Clinical Center, Durham, NC, United States of America.'}, {'ForeName': 'Shivan', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Mary P', 'Initials': 'MP', 'LastName': 'Garrett', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Theresa C', 'Initials': 'TC', 'LastName': 'Wilmot', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Marcano', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Overby', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Glenda A', 'Initials': 'GA', 'LastName': 'Tisdale', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Durkee', 'Affiliation': 'Department of Pharmacy, Durham Veterans Affairs Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bullard', 'Affiliation': 'Department of Pharmacy, Durham Veterans Affairs Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Moahad S', 'Initials': 'MS', 'LastName': 'Dar', 'Affiliation': 'Greenville VA Health Care Center, Greenville, NC, United States of America; Division of Endocrinology, Department of Medicine, Brody School of Medicine at East Carolina University, Greenville, NC, United States of America.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Mundy', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Janette', 'Initials': 'J', 'LastName': 'Hiner', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Sonja K', 'Initials': 'SK', 'LastName': 'Fredrickson', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Nadya T', 'Initials': 'NT', 'LastName': 'Majette Elliott', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Howard', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Deborah H', 'Initials': 'DH', 'LastName': 'Jeter', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Danus', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of Endocrinology, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America. Electronic address: matthew.crowley@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106157']
2919,32971302,"Manual push technique, an alternative route of subcutaneous immunoglobulin administration in chronic inflammatory demyelinating polyradiculoneuropathy: A proof-of-concept study.","OBJECTIVE
Subcutaneous immunoglobulin (SCIg) administered through infusion pump has been reported as effective in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) patients. In this study we evaluate an alternative technique of SCIg administration, based on the delivery of lower volumes administered daily using manual push technique (MPT) in 10 CIDP patients.
METHODS
In this randomized, controlled, two-arm, crossover clinical trial, CIDP patients were randomly assigned 1:1 to receive SCIg either by MPT or pumps for 4 consecutive months with crossover to the other. The primary objective was to assess whether MPT had the same effectiveness as pumps. The secondary objectives were to assess whether MPT resulted in greater plasma IgG levels and improved quality of life (QoL).
RESULTS
Ten patients (mean age = 48.3) were enrolled. No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales). A positive mean variation of 5.4 % in plasma IgG levels in the group treated with MPT was observed at the end of MPT periods. Treatment interference, which is one of the dimensions of the Life Quality Index, showed a significant improvement in the MPT periods.
CONCLUSION
In CIDP patients, the MPT technique was as effective as pump infusion, allowed comparable, slightly increases plasma IgG levels, and also improved the QoL.",2020,"No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales).","['chronic inflammatory demyelinating polyradiculoneuropathy', 'Ten patients (mean age\u202f=\u202f48.3) were enrolled', '10 CIDP patients', 'CIDP patients', 'chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) patients']","['Subcutaneous immunoglobulin (SCIg', 'manual push technique (MPT', 'subcutaneous immunoglobulin administration', 'SCIg either by MPT', 'MPT']","['efficacy parameters (INCAT, MRC, R-ODS, and GS scales', 'plasma IgG levels', 'plasma IgG levels and improved quality of life (QoL']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032587', 'cui_str': 'Polyradiculoneuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",10.0,0.0784501,"No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales).","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Cocito', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: dariococito@yahoo.it.'}, {'ForeName': 'Erdita', 'Initials': 'E', 'LastName': 'Peci', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: erditapeci@gmail.com.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Rigaldo', 'Affiliation': 'Dipartimento di Neuroscienze - Università di Torino, A.O.U. Città della Salute e della Scienza di Torino, Corso Bramante, 88, 10126, Torino, Italy. Electronic address: simonarigaldo@yahoo.com.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Canavese', 'Affiliation': 'Dipartimento di Neuroscienze - Università di Torino, A.O.U. Città della Salute e della Scienza di Torino, Corso Bramante, 88, 10126, Torino, Italy. Electronic address: ccanavese@cittadellasalute.to.it.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Migliaretti', 'Affiliation': 'Dipartimento di Sanità Pubblica e Scienze Pediatriche - Università di Torino, Piazza Polonia, 94, 10126 Torino, Italy. Electronic address: giuseppe.migliaretti@unito.it.'}, {'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Cossa', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: federico.cossa@icsmaugeri.it.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106240']
2920,32971314,Quality of life after response to acute-phase cognitive therapy for recurrent depression.,"BACKGROUND
Adults with major depressive disorder (MDD) often experience reduced quality of life (QOL). Efficacious acute-phase treatments, including cognitive therapy (CT) or medication, decrease depressive symptoms and, to a lesser degree, increase QOL. We tested longer-term changes in QOL after response to acute-phase CT, including the potential effects of continuation treatment for depression and time-lagged relations between QOL and depressive symptoms.
METHODS
Responders to acute-phase CT (N = 290) completed QOL and depressive symptom assessments repeatedly for 32 post-acute months. Higher-risk responders were randomized to 8 months of continuation treatment (CT, fluoxetine, or pill placebo) and then entered a 24-month follow-up. Lower-risk responders were only assessed for 32 months.
RESULTS
On average, large gains in QOL made during acute-phase CT response were maintained for 32 months. Continuation CT or fluoxetine did not improve QOL relative to pill placebo. Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence. Higher QOL predicted subsequent reductions in depressive symptom severity, but depressive symptom severity did not predict subsequent changes in QOL.
LIMITATIONS
Generalization of results to other patient populations, treatments, and measures is uncertain. The clinical trial was not designed to test relations between QOL and depression. Replication is needed before clinical application of these results.
CONCLUSIONS
Gains in QOL made during response to acute-phase CT are relatively stable and may help protect against relapse/recurrence. Continuation CT or fluoxetine may not further improve QOL among acute-phase CT responders.",2020,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","['Responders to acute-phase CT', 'Adults with major depressive disorder (MDD', 'recurrent depression', 'Higher-risk responders']","['cognitive therapy (CT', 'continuation treatment (CT, fluoxetine, or pill placebo', 'fluoxetine']","['QOL relative', 'depressive symptom severity', 'quality of life (QOL', 'QOL and depressive symptom assessments', 'QOL', 'Quality of life']","[{'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",290.0,0.0234422,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","[{'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Vittengl', 'Affiliation': 'Department of Psychology, Truman State University, 100 East Normal Street, Kirksville, MO 63501-4221, USA. Electronic address: vittengl@truman.edu.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Minhajuddin', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'Robin B', 'Initials': 'RB', 'LastName': 'Jarrett', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9149, USA. Electronic address: Robin.Jarrett@UTSouthwestern.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.059']
2921,32971388,Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults.,"BACKGROUND
Cannabis warning labels can communicate risks, but there is little research on warning perceptions and differences by product type.
METHODS
In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco) were randomly assigned to view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis. The warnings described cannabis risks related to psychosis, addiction, lack of FDA oversight, and impaired driving. We used linear regression to examine perceptions of warnings and product harm as a function of product type (dried or edible) and warning. We examined which warning participants selected as most effective for discouraging youth use and impaired driving.
RESULTS
Participants found the addiction warning (cannabis users: B = -1.04, p < 0.001; cannabis non-users: B = 1.17, p < 0.001) and psychosis warning (users: B = -0.65, p < 0.05; non-users: B = -0.71, p < 0.05) less believable than the driving warning but indicated that they learned more from the psychosis warning than the driving warning (users: B = 0.88, p < 0.01; non-users (B = 1.60, p < 0.001). Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05). The psychosis warning was most frequently selected as the best warning for discouraging youth use.
CONCLUSIONS
Warnings have the potential to educate consumers and impact cannabis harm perceptions. Warnings have similar effects across product types, potentially eliminating the need for product type-specific warnings. The association of cannabis use with risk for psychosis, a topic addressed in Canadian warnings, could be a useful topic of focus in U.S. warnings.",2020,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"['In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco', 'Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults']",['view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis'],"['addiction warning', 'psychosis warning']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0556574', 'cui_str': 'Dried flowers'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]",,0.0480856,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"[{'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Pepper', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA. Electronic address: jpepper@rti.org.'}, {'ForeName': 'Youn Ok', 'Initials': 'YO', 'LastName': 'Lee', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Eggers', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Allen', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Nonnemaker', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108275']
2922,32972965,Effect of home-based newborn care on neonatal and infant mortality: a cluster randomised trial in India.,"BACKGROUND
Home-based newborn care has been found to reduce neonatal mortality in rural areas. Study evaluated effectiveness of home-based care delivered by specially recruited newborn care workers- Shishu Rakshak (SR) and existing workers- anganwadi workers (AWW) in reducing neonatal and infant mortality rates.
METHODS
This three-arm, community-based, cluster randomised trial was conducted in five districts in India. Intervention package consisted of pregnancy surveillance, health education, care at birth, care of normal/low birthweight neonates, identification and treatment of sick neonates and young infants using oral and injectable antibiotics and community mobilisation. The package was similar in both intervention arms-SR and AWW; difference being healthcare provider. The control arm received routine health services from the existing health system. Primary outcomes were neonatal and young infant mortality rates at 'endline' period (2008-2009) assessed by an independent team from January to April 2010 in the study clusters.
FINDINGS
A total of 6623, 6852 and 5898 births occurred in the SR, AWW and control arms, respectively, during the endline period; the proportion of facility births were 69.0%, 64.4% and 70.6% in the three arms. Baseline mortality rates were comparable in three arms. During the endline period, the risk of neonatal mortality was 25% lower in the SR arm (adjusted OR 0.75, 95% CI 0.57 to 0.99); the risks of early neonatal mortality, young infant mortality and infant mortality were also lower by 32%, 27%, and 33%, respectively. The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm.
INTERPRETATION
Home-based care is effective in reducing neonatal and infant mortality rates, when delivered by a dedicated worker, even in settings with high rates of facility births.
TRIAL REGISTRATION NUMBER
The study was registered with Clinical Trial Registry of India (CTRI/2011/12/002181).",2020,"The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm.
","['five districts in India', 'sick neonates and young infants using']","['routine health services', 'oral and injectable antibiotics and community mobilisation', 'home-based care delivered by specially recruited newborn care workers- Shishu Rakshak (SR) and existing workers- anganwadi workers (AWW', 'home-based newborn care']","['proportion of facility births', 'risk of neonatal mortality', 'neonatal and infant mortality rates', 'neonatal mortality', 'Baseline mortality rates', 'risks of early neonatal mortality, young infant mortality and infant mortality', 'risks of neonatal, early neonatal, young infant, infant mortality', 'neonatal and young infant mortality rates', 'neonatal and infant mortality']","[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204792', 'cui_str': 'Routine care of newborn'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021278', 'cui_str': 'Mortality, Infant'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1271991', 'cui_str': 'Early neonatal death'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",,0.0793595,"The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm.
","[{'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Rasaily', 'Affiliation': 'Indian Council of Medical Research (ICMR), New Delhi, India reeta.rasaily@gmail.com.'}, {'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Saxena', 'Affiliation': 'Indian Council of Medical Research (ICMR), New Delhi, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Pandey', 'Affiliation': 'Patna Medical College Hospital (PMCH), Patna, India.'}, {'ForeName': 'Bishan S', 'Initials': 'BS', 'LastName': 'Garg', 'Affiliation': 'Mahatma Gandhi Institute of Medical Sciences (MGIMS), Wardha, India.'}, {'ForeName': 'Saraswati', 'Initials': 'S', 'LastName': 'Swain', 'Affiliation': 'National Institute of Applied Human Research & Development (NIAHRD), Cuttack, India.'}, {'ForeName': 'Sharad D', 'Initials': 'SD', 'LastName': 'Iyengar', 'Affiliation': 'Action Research and Training for Health (ARTH), Udaipur, India.'}, {'ForeName': 'Vinita', 'Initials': 'V', 'LastName': 'Das', 'Affiliation': 'King George Medical University (KGMU), Lucknow, India.'}, {'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Patna Medical College Hospital (PMCH), Patna, India.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Mahatma Gandhi Institute of Medical Sciences (MGIMS), Wardha, India.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Sinha', 'Affiliation': 'Indian Council of Medical Research (ICMR), New Delhi, India.'}, {'ForeName': 'Shiv', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Indian Council of Medical Research (ICMR), New Delhi, India.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'National Institute of Medical Statistics, New Delhi, India.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Harshpal Singh', 'Initials': 'HS', 'LastName': 'Sachdev', 'Affiliation': 'Sitaram Bhartia Institute of Science and Research (SBISR), New Delhi, India.'}, {'ForeName': 'Mari Jeeva', 'Initials': 'MJ', 'LastName': 'Sankar', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Siddarth', 'Initials': 'S', 'LastName': 'Ramji', 'Affiliation': 'Maulana Azad Medical College (MAMC), New Delhi, India.'}, {'ForeName': 'Vinod K', 'Initials': 'VK', 'LastName': 'Paul', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Abhay T', 'Initials': 'AT', 'LastName': 'Bang', 'Affiliation': 'Society for Education, Action and Research in Community Health (SEARCH), Gadchiroli, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ global health,['10.1136/bmjgh-2017-000680']
2923,32976205,Intranasal dexmedetomidine versus oral midazolam premedication to prevent emergence delirium in children undergoing strabismus surgery: A randomised controlled trial.,"BACKGROUND
Dexmedetomidine is being used increasingly as a premedicant in the paediatric population. However, the effectiveness of pre-operative intranasal dexmedetomidine premedication, compared with oral midazolam, for emergence delirium is not well characterised.
OBJECTIVE
To identify the effectiveness of pre-operative intranasal dexmedetomidine for emergence delirium in the paediatric patient population following general anaesthesia.
DESIGN
A prospective, randomised, double-blind, parallel-group, placebo-controlled trial.
SETTING
Single university teaching hospital, from September 2013 to August 2014.
PATIENTS
One hundred and fifty-six patients undergoing anaesthesia for strabismus surgery were included in the study.
INTERVENTION
Patients were randomised in a 1 : 1 : 1 ratio to receive premedication with intranasal dexmedetomidine 2 μg kg (the dexmedetomidine group), oral midazolam 0.5 mg kg (the midazolam group), or 0.9% saline (the placebo group).
MAIN OUTCOME MEASURES
The primary outcome was the incidence of emergence delirium assessed by the Paediatric Anaesthesia Emergence Delirium scale. Secondary outcomes included the quality of the inhalational induction, emergence time, postoperative pain intensity, length of stay in the postanaesthesia care unit, the incidence of postoperative nausea or vomiting (PONV) and parents' satisfaction.
RESULTS
The incidence of emergence delirium was lower in patients given dexmedetomidine compared with that in patients given midazolam (11.5 versus 44%, relative risk = 0.262, 95% confidence interval 0.116 to 0.592) or 0.9% saline (11.5 versus 49%, relative risk = 0.235, 95% confidence interval 0.105 to 0.525). Likewise, the incidence of PONV was lower in the dexmedetomidine group (3.8%) than that in the midazolam (22%; P = 0.006) or placebo (29.4%; P < 0.001) groups. However, there was no difference among the groups concerning postoperative pain scores and length of postanaesthesia care unit stay.
CONCLUSION
In paediatric patients undergoing strabismus surgery intranasal dexmedetomidine 2 μg kg premedication decreases the incidence of emergence delirium and PONV, and improves parents' satisfaction compared with oral midazolam.
TRIAL REGISTRATION
ClinicalTrials.gov (identifier: NCT01895023).",2020,"However, there was no difference among the groups concerning postoperative pain scores and length of postanaesthesia care unit stay.
","['paediatric patients undergoing strabismus surgery intranasal', 'Single university teaching hospital, from September 2013 to August 2014', 'paediatric patient population following general anaesthesia', 'children undergoing strabismus surgery', 'One hundred and fifty-six patients undergoing anaesthesia for strabismus surgery were included in the study']","['pre-operative intranasal dexmedetomidine', 'midazolam premedication', 'Dexmedetomidine', 'placebo', 'dexmedetomidine', 'intranasal dexmedetomidine 2\u200aμg\u200akg (the dexmedetomidine group), oral midazolam 0.5\u200amg\u200akg (the midazolam group), or 0.9% saline (the placebo', 'midazolam', 'Intranasal dexmedetomidine']","[""quality of the inhalational induction, emergence time, postoperative pain intensity, length of stay in the postanaesthesia care unit, the incidence of postoperative nausea or vomiting (PONV) and parents' satisfaction"", 'incidence of emergence delirium', 'postoperative pain scores and length of postanaesthesia care unit stay', ""incidence of emergence delirium and PONV, and improves parents' satisfaction"", 'incidence of PONV', 'incidence of emergence delirium assessed by the Paediatric Anaesthesia Emergence Delirium scale']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0197981', 'cui_str': 'Strabismus surgery'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0412768', 'cui_str': 'Inhalational induction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",156.0,0.767456,"However, there was no difference among the groups concerning postoperative pain scores and length of postanaesthesia care unit stay.
","[{'ForeName': 'Yusheng', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ''}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Jiancheng', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001270']
2924,32977137,Therapeutic versus prophylactic anticoagulation for severe COVID-19: A randomized phase II clinical trial (HESACOVID).,"INTRODUCTION
Coronavirus disease 2019 (COVID-19) causes a hypercoagulable state. Several autopsy studies have found microthrombi in pulmonary circulation.
METHODS
In this randomized, open-label, phase II study, we randomized COVID-19 patients requiring mechanical ventilation to receive either therapeutic enoxaparin or the standard anticoagulant thromboprophylaxis. We evaluated the gas exchange over time through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, 7, and 14 days after randomization, the time until successful liberation from mechanical ventilation, and the ventilator-free days.
RESULTS
Ten patients were assigned to the therapeutic enoxaparin and ten patients to prophylactic anticoagulation. There was a statistically significant increase in the PaO2/FiO2 ratio over time in the therapeutic group (163 [95% confidence interval - CI 133-193] at baseline, 209 [95% CI 171-247] after 7 days, and 261 [95% CI 230-293] after 14 days), p = 0.0004. In contrast, we did not observe this improvement over time in the prophylactic group (184 [95% CI 146-222] at baseline, 168 [95% CI 142-195] after 7 days, and 195 [95% CI 128-262] after 14 days), p = 0.487. Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = 0.031 and more ventilator-free days (15 days [interquartile range IQR 6-16] versus 0 days [IQR 0-11]), p = 0.028 when compared to the prophylactic group.
CONCLUSION
Therapeutic enoxaparin improves gas exchange and decreases the need for mechanical ventilation in severe COVID-19.
TRIAL REGISTRATION
REBEC RBR-949z6v.",2020,"Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = ","['COVID-19 patients requiring mechanical ventilation to receive either', 'severe COVID-19']","['Therapeutic versus prophylactic anticoagulation', 'enoxaparin', 'prophylactic anticoagulation', 'therapeutic enoxaparin', 'therapeutic enoxaparin or the standard anticoagulant thromboprophylaxis']","['PaO2/FiO2 ratio', 'higher ratio of successful liberation from mechanical ventilation', 'gas exchange over time through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]",10.0,0.230806,"Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = ","[{'ForeName': 'Anna Cristina Bertoldi', 'Initials': 'ACB', 'LastName': 'Lemos', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Douglas Alexandre', 'Initials': 'DA', 'LastName': 'do Espírito Santo', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Maísa Cabetti', 'Initials': 'MC', 'LastName': 'Salvetti', 'Affiliation': 'Hospital Estadual de Américo Brasiliense, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Renato Noffs', 'Initials': 'RN', 'LastName': 'Gilio', 'Affiliation': 'Hospital Estadual de Américo Brasiliense, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Lucas Barbosa', 'Initials': 'LB', 'LastName': 'Agra', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pazin-Filho', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Carlos Henrique', 'Initials': 'CH', 'LastName': 'Miranda', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil. Electronic address: chmiranda@fmrp.usp.br.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.026']
2925,32977202,The differential impact of viewing fitspiration and thinspiration images on men's body image concerns: An experimental ecological momentary assessment study.,"To date, little is known about the impact of fitspiration and thinspiration exposure on men, as previous studies on these social media trends were primarily conducted on women. Male participants (n = 223) completed baseline measures of trait body image, then used a smartphone application to complete up to six state-based assessments daily for seven days. In each assessment, participants were randomly assigned to one of three image conditions (fitspiration, thinspiration, or neutral). Before and after viewing each image, they reported state body fat dissatisfaction, muscularity dissatisfaction, negative mood, and urge to engage in behaviours to reduce body fat and increase muscularity. Multi-level analyses revealed that compared to viewing neutral images, viewing fitspiration images increased men's body dissatisfaction, whereas viewing thinspiration images decreased body dissatisfaction. Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat. Men with greater baseline muscularity dissatisfaction and higher appearance comparison were most vulnerable to muscularity dissatisfaction after viewing fitspiration images. Findings suggest the importance of limiting exposure to fitspiration imagery and implementing social media literacy programmes for men and well as women.",2020,"Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat.","['men and well as women', 'Male participants (n = 223', ""men's body image concerns""]",['viewing fitspiration and thinspiration images'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",[],223.0,0.019817,"Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat.","[{'ForeName': 'Zhi Wei', 'Initials': 'ZW', 'LastName': 'Yee', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: zhiwei@student.unimelb.edu.au.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Griffiths', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: scott.griffiths@unimelb.edu.au.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fuller-Tyszkiewicz', 'Affiliation': 'Centre for Social and Early Emotional Development, School of Psychology, Deakin University, Burwood, VIC, 3125, Australia; School of Psychology, Deakin University, Burwood, VIC, 3125, Australia. Electronic address: matthew.fuller.tyszkiewicz@deakin.edu.au.'}, {'ForeName': 'Khandis', 'Initials': 'K', 'LastName': 'Blake', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: khandis.blake@unimelb.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': 'School of Psychology, Deakin University, Burwood, VIC, 3125, Australia. Electronic address: Ben.Richardson@nousgroup.com.au.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Krug', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: Isabel.krug@unimelb.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.08.008']
2926,32977404,An Exploratory Analysis of Changes in Mental Wellbeing Following Curcumin and Fish Oil Supplementation in Middle-Aged and Older Adults.,"Curcumin has previously been shown to enhance mood in non-depressed older adults. However, observed benefits were limited to short-term supplementation (4 weeks). In a 16 week randomized, double-blind, placebo-controlled, 2 × 2 factorial design trial, we supplemented overweight or obese non-depressed adults (50-80 years) with curcumin (160 mg/day), fish oil (2000 mg docosahexaenoic acid +400 mg eicosapentaenoic acid/day), or a combination of both. Secondary outcomes included mental wellbeing measures (mood states and subjective memory complaints (SMCs)) and quality of life (QoL). Furthermore, plasma apolipoprotein E4 (APOE4) was measured to determine whether APOE4 status influences responses to fish oil. Curcumin improved vigour ( p = 0.044) compared to placebo and reduced SMCs compared to no curcumin treatment ( p = 0.038). Fish oil did not affect any mood states, SMCs or QoL; however, responses to fish oil were affected by APOE4 status. In APOE4 non-carriers, fish oil increased vigour ( p = 0.030) and reduced total mood disturbances ( p = 0.048) compared to placebo. Improvements in mental wellbeing were correlated with increased QoL. Combining curcumin with fish oil did not result in additive effects. This exploratory analysis indicates that regular supplementation with either curcumin or fish oil (limited to APOE4 non-carriers) has the potential to improve some aspects of mental wellbeing in association with better QoL.",2020,Curcumin improved vigour ( p = 0.044) compared to placebo and reduced SMCs compared to no curcumin treatment ( p = 0.038).,"['non-depressed older adults', 'supplemented overweight or obese non-depressed adults (50-80 years) with', 'Middle-Aged and Older Adults']","['Fish oil', 'curcumin', 'curcumin or fish oil', 'fish oil (2000 mg docosahexaenoic acid +400 mg eicosapentaenoic acid/day), or a combination of both', 'placebo', 'Curcumin and Fish Oil Supplementation']","['SMCs', 'total mood disturbances', 'Furthermore, plasma apolipoprotein E4 (APOE4', 'mental wellbeing', 'mood states, SMCs or QoL', 'Mental Wellbeing', 'additive effects', 'mental wellbeing measures (mood states and subjective memory complaints (SMCs)) and quality of life (QoL']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0052201', 'cui_str': 'Apolipoprotein E4'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0442796', 'cui_str': 'Additive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]",,0.371043,Curcumin improved vigour ( p = 0.044) compared to placebo and reduced SMCs compared to no curcumin treatment ( p = 0.038).,"[{'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Kuszewski', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Peter R C', 'Initials': 'PRC', 'LastName': 'Howe', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Rachel H X', 'Initials': 'RHX', 'LastName': 'Wong', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan 2308, Australia.'}]",Nutrients,['10.3390/nu12102902']
2927,32977459,Food Addiction Is Associated with Binge Eating and Psychiatric Distress among Post-Operative Bariatric Surgery Patients and May Improve in Response to Cognitive Behavioural Therapy.,"The current study examined clinical correlates of food addiction among post-operative bariatric surgery patients, compared the clinical characteristics of patients with versus without food addiction, and examined whether a brief telephone-based cognitive behavioural therapy (Tele-CBT) intervention improves food addiction symptomatology among those with food addiction. Participants ( N = 100) completed measures of food addiction, binge eating, depression, and anxiety 1 year following bariatric surgery, were randomized to receive either Tele-CBT or standard bariatric post-operative care, and then, repeated the measure of food addiction at 1.25 and 1.5 years following surgery. Thirteen percent of patients exceeded the cut-off for food addiction at 1 year post-surgery, and this subgroup of patients reported greater binge eating characteristics and psychiatric distress compared to patients without food addiction. Among those with food addiction, Tele-CBT was found to improve food addiction symptomatology immediately following the intervention. These preliminary findings suggest that Tele-CBT may be helpful, at least in the short term, in improving food addiction symptomatology among some patients who do not experience remission of food addiction following bariatric surgery; however, these findings require replication in a larger sample.",2020,"Among those with food addiction, Tele-CBT was found to improve food addiction symptomatology immediately following the intervention.","['post-operative bariatric surgery patients', 'Participants ( N = 100) completed measures of food addiction, binge eating, depression, and anxiety 1 year following bariatric surgery']","['telephone-based cognitive behavioural therapy (Tele-CBT) intervention', 'Tele-CBT or standard bariatric post-operative care']","['binge eating characteristics and psychiatric distress', 'Binge Eating and Psychiatric Distress', 'food addiction symptomatology']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}]",,0.0444962,"Among those with food addiction, Tele-CBT was found to improve food addiction symptomatology immediately following the intervention.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Cassin', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, ON M5B 2K3, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Leung', 'Affiliation': 'Centre for Mental Health, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Raed', 'Initials': 'R', 'LastName': 'Hawa', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON M5T 1R8, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Wnuk', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON M5T 1R8, Canada.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Jackson', 'Affiliation': 'Bariatric Surgery Program, Toronto Western Hospital, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Sockalingam', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON M5T 1R8, Canada.'}]",Nutrients,['10.3390/nu12102905']
2928,32977639,"Effect of a Nutrient-Rich, Food-Based Supplement Given to Rural Vietnamese Mothers Prior to or during Pregnancy on the Trajectories of Nutrient Biomarkers.","Nutrient interventions initiated after conception tend to have modest effects on maternal nutritional status and pregnancy outcomes. Thus, we compared the association between micronutrient intakes and the trajectories of their biomarkers before and during pregnancy. Data from a randomized trial of the effect of a nutrient-rich, food-based supplement given to 317 Vietnamese women prior to or during pregnancy on birth outcomes were used to assess nutrient intakes with biomarker trajectories of zinc, iron, folate, cobalamin, and vitamin A using linear mixed regression models. The circulating plasma or serum trajectories of all five micronutrients were associated to their baseline levels ( p < 0.0001). Plasma zinc trajectories were also related to farm work ( p = 0.024). Cobalamin and vitamin A trajectories were associated with gestational weight gain ( p = 0.003 and p = -0.037, respectively). In this population of rural Vietnamese women, nutrient intakes during pregnancy did not affect biomarker trajectories. The primary determinant of each nutrient biomarker trajectory was its respective baseline level prior to conception.",2020,"Cobalamin and vitamin A trajectories were associated with gestational weight gain ( p = 0.003 and p = -0.037, respectively).","['rural Vietnamese women', '317 Vietnamese women prior to or during pregnancy on birth outcomes', 'Rural Vietnamese Mothers Prior to or during Pregnancy on the Trajectories of Nutrient Biomarkers']","['nutrient-rich, food-based supplement', 'Nutrient-Rich, Food-Based Supplement Given']","['circulating plasma or serum trajectories', 'gestational weight gain', 'maternal nutritional status and pregnancy outcomes', 'Plasma zinc trajectories']","[{'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}]",317.0,0.0269425,"Cobalamin and vitamin A trajectories were associated with gestational weight gain ( p = 0.003 and p = -0.037, respectively).","[{'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Goletzke', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California Berkeley, Berkeley, CA 94720, USA.'}, {'ForeName': 'Hoang T', 'Initials': 'HT', 'LastName': 'Nga', 'Affiliation': 'National Institute of Nutrition, Hanoi 100000, Vietnam.'}, {'ForeName': 'Phi N', 'Initials': 'PN', 'LastName': 'Quyen', 'Affiliation': 'National Institute of Nutrition, Hanoi 100000, Vietnam.'}, {'ForeName': 'Tu', 'Initials': 'T', 'LastName': 'Ngu', 'Affiliation': 'National Institute of Nutrition, Hanoi 100000, Vietnam.'}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'King', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California Berkeley, Berkeley, CA 94720, USA.'}]",Nutrients,['10.3390/nu12102913']
2929,32992075,Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo in critically-ill patients with COVID-19: Rationale and design of the INSPIRATION/INSPIRATION-S studies.,"BACKGROUND
Microvascular and macrovascular thrombotic events are among the hallmarks of coronavirus disease 2019 (COVID-19). Furthermore, the exuberant immune response is considered an important driver of pulmonary and extrapulmonary manifestations of COVID-19. The optimal management strategy to prevent thrombosis in critically-ill patients with COVID-19 remains unknown.
METHODS
The Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) and INSPIRATION-statin (INSPIRATION-S) studies test two independent hypotheses within a randomized controlled trial with 2 × 2 factorial design. Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation. The 600 patients undergoing this randomization will be screened and if meeting the eligibility criteria, will undergo an additional double-blind stratified randomization to atorvastatin 20 mg daily versus matching placebo. The primary endpoint, for both hypotheses will be tested for superiority and includes a composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death within 30 days from enrollment. Key secondary endpoints include all-cause mortality, adjudicated VTE, and ventilator-free days. Key safety endpoints include major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL) for the anticoagulation hypothesis. In a prespecified secondary analysis for non-inferiority, the study will test for the non-inferiority of intermediate intensity versus standard dose anticoagulation for major bleeding, considering a non-inferiority margin of 1.8 based on odds ratio. Key safety endpoints for the statin hypothesis include rise in liver enzymes >3 times upper normal limit and clinically-diagnosed myopathy. The primary analyses will be performed in the modified intention-to-treat population. Results will be tested in exploratory analyses across key subgroups and in the intention-to-treat and per-protocol cohorts.
CONCLUSIONS
INSPIRATION and INSPIRATON-S studies will help address clinically-relevant questions for antithrombotic therapy and thromboinflammatory therapy in critically-ill patients with COVID-19.",2020,Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation.,"['critically-ill patients with COVID-19 remains unknown', '600 patients undergoing this randomization will be screened and if meeting the eligibility criteria', 'cRitically-ill pATIents with COVID-19', 'critically-ill patients with COVID-19', 'Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19']","['Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo', 'Prophylactic anticoagulation', 'atorvastatin 20\xa0mg daily versus matching placebo']","['major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL', 'composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death', 'cause mortality, adjudicated VTE, and ventilator-free days']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1379773', 'cui_str': 'atorvastatin 20 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",600.0,0.474016,Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation.,"[{'ForeName': 'Behnood', 'Initials': 'B', 'LastName': 'Bikdeli', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Yale/YNHH Center for Outcomes Research & Evaluation, New Haven, CT, USA; Cardiovascular Research Foundation (CRF), New York, NY, USA. Electronic address: bbikdeli@bwh.harvard.edu.""}, {'ForeName': 'Azita H', 'Initials': 'AH', 'LastName': 'Talasaz', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Rashidi', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Sharif-Kashani', 'Affiliation': 'Tobacoo Prevention and control Research center, National Research lnstitute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran; Lung Transplantion Research Center, Department of Cardiology, National Research Institute of Tuberculosls and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Farrokhpour', 'Affiliation': 'Firouzgar Hospital, Department of Internal Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Bakhshandeh', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Hashem', 'Initials': 'H', 'LastName': 'Sezavar', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dabbagh', 'Affiliation': 'Department of Anesthesiology, School of Medicine Anesthesiology Research Center Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Beigmohammadi', 'Affiliation': 'Anesthesiology and Intensive Care, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Payandemehr', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Yadollahzadeh', 'Affiliation': 'Firouzgar Hospital, Department of Internal Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Taghi', 'Initials': 'T', 'LastName': 'Riahi', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Jamalkhani', 'Affiliation': 'Student Research Committee, Iran University of Medical Sciences, Tehran, Iran; Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Rezaeifar', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Abedini', 'Affiliation': 'Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Lookzadeh', 'Affiliation': 'Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shaghayegh', 'Initials': 'S', 'LastName': 'Shahmirzaei', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ouria', 'Initials': 'O', 'LastName': 'Tahamtan', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Matin', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Ehsan', 'Initials': 'SE', 'LastName': 'Parhizgar', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jimenez', 'Affiliation': 'Respiratory Department, Hospital Ramón y Cajal (IRYCIS), Madrid, Spain; Medicine Department, Universidad de Alcalá (IRYCIS), Madrid, Spain; CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Aakriti', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Madhavan', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Sahil A', 'Initials': 'SA', 'LastName': 'Parikh', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Monreal', 'Affiliation': 'Department of Internal Medicine, Hospital Germans Trias i Pujol, Badalona, Barcelona, Universidad Católica de Murcia, Murcia, Spain.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Hadavand', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Hajighasemi', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Maleki', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Sadeghian', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Mohebbi', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Piazza', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Harlan M', 'Initials': 'HM', 'LastName': 'Krumholz', 'Affiliation': 'Yale/YNHH Center for Outcomes Research & Evaluation, New Haven, CT, USA; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA; Department of Health Policy and Adminitration, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Parham', 'Initials': 'P', 'LastName': 'Sadeghipour', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Iran; Clinical Trial Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Iran. Electronic address: psadeghipour@hotmail.com.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.027']
2930,32992107,Disseminating trial results: We can have both faster and better.,,2020,,[],[],[],[],[],[],,0.0376918,,"[{'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Simon', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA. Electronic address: Gregory.E.Simon@kp.org.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Richesson', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}]","Healthcare (Amsterdam, Netherlands)",['10.1016/j.hjdsi.2020.100474']
2931,32992136,Improving the performance of CNN to predict the likelihood of COVID-19 using chest X-ray images with preprocessing algorithms.,"OBJECTIVE
This study aims to develop and test a new computer-aided diagnosis (CAD) scheme of chest X-ray images to detect coronavirus (COVID-19) infected pneumonia.
METHOD
CAD scheme first applies two image preprocessing steps to remove the majority of diaphragm regions, process the original image using a histogram equalization algorithm, and a bilateral low-pass filter. Then, the original image and two filtered images are used to form a pseudo color image. This image is fed into three input channels of a transfer learning-based convolutional neural network (CNN) model to classify chest X-ray images into 3 classes of COVID-19 infected pneumonia, other community-acquired no-COVID-19 infected pneumonia, and normal (non-pneumonia) cases. To build and test the CNN model, a publicly available dataset involving 8474 chest X-ray images is used, which includes 415, 5179 and 2,880 cases in three classes, respectively. Dataset is randomly divided into 3 subsets namely, training, validation, and testing with respect to the same frequency of cases in each class to train and test the CNN model.
RESULTS
The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes. CAD also yields 98.4 % sensitivity (124/126) and 98.0 % specificity (2371/2418) in classifying cases with and without COVID-19 infection. However, without using two preprocessing steps, CAD yields a lower classification accuracy of 88.0 % (2239/2544).
CONCLUSION
This study demonstrates that adding two image preprocessing steps and generating a pseudo color image plays an important role in developing a deep learning CAD scheme of chest X-ray images to improve accuracy in detecting COVID-19 infected pneumonia.",2020,"The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes.",[],[],[],[],[],[],,0.0223987,"The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes.","[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Heidari', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA. Electronic address: Morteza.heidari@ou.edu.'}, {'ForeName': 'Seyedehnafiseh', 'Initials': 'S', 'LastName': 'Mirniaharikandehei', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Abolfazl Zargari', 'Initials': 'AZ', 'LastName': 'Khuzani', 'Affiliation': 'Department of Electrical and Computer Engineering, University of California Santa Cruz, Santa Cruz, CA 95064, USA.'}, {'ForeName': 'Gopichandh', 'Initials': 'G', 'LastName': 'Danala', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104284']
2932,32992151,Cost and cost-effectiveness of interim methadone treatment and patient navigation initiated in jail.,"BACKGROUND
Individuals with opioid use disorder (OUD) who are released from pre-trial detention in jail have a high risk of opioid relapse. While several interventions for OUD initiated during incarceration have been studied, few have had an economic evaluation. As part of a three-group randomized trial, we estimated the cost and cost-effectiveness of a negative urine opioid test. Detainees were assigned to interim methadone (IM) in jail with continued methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group.
METHODS
We implemented a micro-costing approach from the provider's perspective to estimate the cost per participant in jail and over the 12 months post-release from jail. Economic data included jail-based and community-based service utilization, self-reported healthcare utilization and justice system involvement, and administrative arrest records. Our outcome measure is the number of participants with a negative opioid urine test at their 12-month follow-up. We calculated incremental cost-effectiveness ratios (ICERs) for intervention costs only and costs from a societal perspective.
RESULTS
The average cost of providing patient navigation services per individual beginning in jail and continuing in the community was $283. We find that IM is dominated by ETAU and IM + PN. Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
CONCLUSIONS
IM + PN is almost certainly the cost-effective choice from both an intervention provider and societal perspective.",2020,"Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
","['patient navigation initiated in jail', 'Individuals with opioid use disorder (OUD']","['interim methadone', 'methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group', 'negative urine opioid test']","['incremental cost-effectiveness ratios (ICERs', 'average cost of providing patient navigation services', 'cost and cost-effectiveness', 'Cost and cost-effectiveness']","[{'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",,0.0840355,"Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
","[{'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Zarkin', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Orme', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States. Electronic address: sorme@rti.org.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Dunlap', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Kelly', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}, {'ForeName': 'Shannon G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, 4094 Campus Drive, College Park, MD 20742, United States.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108292']
2933,32974672,In-vitro maturation of oocytes versus conventional IVF in women with infertility and a high antral follicle count: a randomized non-inferiority controlled trial.,"STUDY QUESTION
Is one cycle of IVM non-inferior to one cycle of conventional in IVF with respect to live birth rates in women with high antral follicle counts (AFCs)?
SUMMARY ANSWER
We could not demonstrate non-inferiority of IVM compared with IVF.
WHAT IS KNOWN ALREADY
IVF with ovarian hyperstimulation has limitations in some subgroups of women at high risk of ovarian stimulation, such as those with polycystic ovary syndrome. IVM is an alternative ART for these women. IVM may be a feasible alternative to IVF in women with a high AFC, but there is a lack of data from randomized clinical trials comparing IVM with IVF in women at high risk of ovarian hyperstimulation syndrome.
STUDY DESIGN, SIZE, DURATION
This single-center, randomized, controlled non-inferiority trial was conducted at an academic infertility center in Vietnam from January 2018 to April 2019.
PARTICIPANTS/MATERIALS, SETTING, METHODS
In total, 546 women with an indication for ART and a high AFC (≥24 follicles in both ovaries) were randomized to the IVM (n = 273) group or the IVF (n = 273) group; each underwent one cycle of IVM with a prematuration step versus one cycle of IVF using a standard gonadotropin-releasing hormone antagonist protocol with gonadotropin-releasing hormone agonist triggering. The primary endpoint was live birth rate after the first embryo transfer. The non-inferiority margin for IVM versus IVF was -10%.
MAIN RESULTS AND THE ROLE OF CHANCE
Live birth after the first embryo transfer occurred in 96 women (35.2%) in the IVM group and 118 women (43.2%) in the IVF group (absolute risk difference -8.1%; 95% confidence interval (CI) -16.6%, 0.5%). Cumulative ongoing pregnancy rates at 12 months after randomization were 44.0% in the IVM group and 62.6% in the IVF group (absolute risk difference -18.7%; 95% CI -27.3%, -10.1%). Ovarian hyperstimulation syndrome did not occur in the IVM group, versus two cases in the IVF group. There were no statistically significant differences between the IVM and IVF groups with respect to the occurrence of pregnancy complications, obstetric and perinatal complications, preterm delivery, birth weight and neonatal complications.
LIMITATIONS, REASONS FOR CAUTION
The main limitation of the study was its open-label design. In addition, the findings are only applicable to IVM conducted using the prematuration step protocol used in this study. Finally, the single ethnicity population limits the external generalizability of the findings.
WIDER IMPLICATIONS OF THE FINDINGS
Our randomized clinical trial compares live birth rates after IVM and IVF. Although IVM is a viable and safe alternative to IVF that may be suitable for some women seeking a mild ART approach, the current study findings approach inferiority for IVM compared with IVF when cumulative outcomes are considered. Future research should incorporate multiple cycles of IVM in the study design to estimate cumulative fertility outcomes and better inform clinical decision-making.
STUDY FUNDING/COMPETING INTEREST(S)
This work was partly supported by Ferring grant number 000323 and funded by the Vietnam National Foundation for Science and Technology Development (NAFOSTED) and by the Fund for Research Flanders (FWO). LNV has received speaker and conference fees from Merck, grant, speaker and conference fees from Merck Sharpe and Dohme, and speaker, conference and scientific board fees from Ferring; TMH has received speaker fees from Merck, Merck Sharp and Dohme, and Ferring; RJN has received conference and scientific board fees from Ferring, is a minor shareholder in an IVF company, and receives grant funding from the National Health and Medical Research Council (NHMRC) of Australia; BWM has acted as a paid consultant to Merck, ObsEva and Guerbet, and is the recipient of grant money from an NHMRC Investigator Grant; RBG reports grants and fellowships from the NHMRC of Australia; JS reports lecture fees from Ferring Pharmaceuticals, Biomérieux, Besins Female Healthcare and Merck, grants from Fund for Research Flanders (FWO), and is co-inventor on granted patents on CAPA-IVM methodology in the US (US10392601B2) and Europe (EP3234112B1); TDP, VQD, VNAH, NHG, AHL, THP and RW have no financial relationships with any organizations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work.
TRIAL REGISTRATION NUMBER
NCT03405701 (www.clinicaltrials.gov).
TRIAL REGISTRATION DATE
16 January 2018.
DATE OF FIRST PATENT’S ENROLMENT
25 January 2018.",2020,"There were no statistically significant differences between the IVM and IVF groups with respect to the occurrence of pregnancy complications, obstetric and perinatal complications, preterm delivery, birth weight and neonatal complications.
","['16 January 2018', 'academic infertility center in Vietnam from January 2018 to April 2019', 'women with a high AFC', 'women with infertility and a high antral follicle count', 'women with high antral follicle counts (AFCs', '546 women with an indication for ART and a high AFC (≥24 follicles in both ovaries']","['conventional IVF', 'IVM and IVF', 'IVM with a prematuration step versus one cycle of IVF using a standard gonadotropin-releasing hormone antagonist protocol with gonadotropin-releasing hormone agonist triggering', 'IVF', 'IVM', 'IVF with ovarian hyperstimulation', 'LNV']","['live birth rate after the first embryo transfer', 'Cumulative ongoing pregnancy rates', 'Live birth', 'occurrence of pregnancy complications, obstetric and perinatal complications, preterm delivery, birth weight and neonatal complications', 'Ovarian hyperstimulation syndrome']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0227898', 'cui_str': 'Both ovaries'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0596795', 'cui_str': 'In Vivo Microscopy'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0549383', 'cui_str': 'Hyperstimulation of ovaries'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032962', 'cui_str': 'Complication of pregnancy'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}]",546.0,0.265161,"There were no statistically significant differences between the IVM and IVF groups with respect to the occurrence of pregnancy complications, obstetric and perinatal complications, preterm delivery, birth weight and neonatal complications.
","[{'ForeName': 'Lan N', 'Initials': 'LN', 'LastName': 'Vuong', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vu N A', 'Initials': 'VNA', 'LastName': 'Ho', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tuong M', 'Initials': 'TM', 'LastName': 'Ho', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vinh Q', 'Initials': 'VQ', 'LastName': 'Dang', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tuan H', 'Initials': 'TH', 'LastName': 'Phung', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nhu H', 'Initials': 'NH', 'LastName': 'Giang', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Anh H', 'Initials': 'AH', 'LastName': 'Le', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Toan D', 'Initials': 'TD', 'LastName': 'Pham', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Smitz', 'Affiliation': 'Follicle Biology Laboratory, Free University of Brussels (VUB), Brussels, Belgium.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Gilchrist', 'Affiliation': ""School of Women's and Children's Health, University of New South Wales Sydney, New South Wales, Australia.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Norman', 'Affiliation': 'Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa240']
2934,32977025,Seizure threshold manipulation in electroconvulsive therapy via repetitive transcranial magnetic stimulation. A novel way of augmentation?,"INTRODUCTION
A high seizure threshold (ST) is an impeding factor in certain patients, potentially preventing a successful electroconvulsive therapy (ECT) treatment. Several pharmacological and non-pharmacological methods have been put forward to augment ECT in such patients, however, to this date, only a handful of case reports existed about the potential role of repetitive transcranial magnetic stimulation (rTMS), as an augmentation method.
OBJECTIVES
and Methods: In this randomized, double-blinded, sham controlled study, we set out to test the hypothesis of whether the application of high frequency transcranial magnetic stimulation (HF rTMS) lowers the seizure threshold for electroconvulsive therapy and whether it has an effect on other aspects of ECT treatment, such as seizure duration (SD), efficacy and safety.
RESULTS
46 patients treated for a major depressive episode, indicated for ECT, were recruited to this study. A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23 mC to 22.4 mC, p < 0.001 (Wilcox test). We had not observed a significant effect of TMS stimulation before ECT on seizure duration or clinical outcome. Another potentially important observation of this study is that 4 patients in the experimental group developed transient symptoms of hypomania/mania, all of which were stabilized after the combined stimulation protocol was halted spontaneously within a week, without the need to administer mood stabilizers.
CONCLUSION
It is likely that HF rTMS stimulation prior to ECT is a novel and simple way of reducing the ST, which is useful in certain groups of patients undergoing this important treatment modality.",2020,"A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23mC to 22.4mC, p < 0.001 (Wilcox test).","['46 patients treated for a major depressive episode, indicated for ECT']","['electroconvulsive therapy via repetitive transcranial magnetic stimulation', 'repetitive transcranial magnetic stimulation (rTMS', 'high frequency transcranial magnetic stimulation (HF rTMS']","['seizure duration (SD), efficacy and safety', 'seizure threshold', 'transient symptoms of hypomania/mania', 'TMS stimulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0241934', 'cui_str': 'Hypomania'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",46.0,0.0778151,"A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23mC to 22.4mC, p < 0.001 (Wilcox test).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Buday', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic. Electronic address: jozef.buday@vfn.cz.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Albrecht', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Podgorná', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mareš', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Le', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Čapek', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mahrík', 'Affiliation': 'Institute of Clinical and Experimental Medicine, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pol', 'Affiliation': 'Institute of Clinical and Experimental Medicine, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raboch', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Anders', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}]",Brain stimulation,['10.1016/j.brs.2020.09.008']
2935,32977661,Acute Effects of Aerobic Exercise on Somatosensory-Evoked Potentials in Patients with Mild Cognitive Impairment.,"Mild cognitive impairment (MCI) is becoming a serious problem for developing countries as the lifespan of populations increases. Exercise is known to be clinically beneficial for MCI patients. Somatosensory-evoked potentials (SEPs) may be a potential diagnostic and prognostic marker for this population. The objective of this study was to determine the acute effects of aerobic exercise on SEPs in patients with MCI, to test whether SEPs are sensitive enough to detect improvements in early somatosensory processing. The study had a randomized parallel-group design and included 28 MCI subjects (14 in the experimental group and 14 in the control group). The experimental intervention was 20 min of aerobic exercise using a stationary bicycle. The control intervention involved 20 min of movements and stretches. Subjects were assessed before and after a single intervention session. SEPs were recorded by stimulating the median nerve of the dominant hand. Analysis of normalized SEP peak amplitudes showed that a single session of aerobic activity significantly reduced the N30 peak at the F3 channel ( p = 0.03). There were no significant effects of aerobic exercise on SEP peak latencies. The results indicate that 20 min of aerobic exercise has a significant effect on the N30 SEP peak amplitude in MCI patients. The results suggest that aerobic exercise is likely to provide sensory-enriching inputs that enhance sensorimotor integration. Future studies should assess the effects of aerobic exercise on somatosensory processing in progressive stages of Alzheimer's disease, longer exercise durations, and multiple exercise sessions.",2020,The results indicate that 20 min of aerobic exercise has a significant effect on the N30 SEP peak amplitude in MCI patients.,"['patients with MCI', 'Patients with Mild Cognitive Impairment', 'Mild cognitive impairment (MCI', '28 MCI subjects (14 in the experimental group and 14 in the control group']","['aerobic exercise using a stationary bicycle', 'Aerobic Exercise', 'aerobic exercise', 'Somatosensory-evoked potentials (SEPs']","['N30 SEP peak amplitude', 'SEP peak latencies', 'normalized SEP peak amplitudes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0392218', 'cui_str': 'Bicycle exerciser'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",28.0,0.0984768,The results indicate that 20 min of aerobic exercise has a significant effect on the N30 SEP peak amplitude in MCI patients.,"[{'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Amjad', 'Affiliation': 'Neurobiology Laboratory, Department of Healthcare Biotechnology, Atta-ur-Rahman School of Applied Biosciences, National University of Sciences and Technology, Islamabad 44000, Pakistan.'}, {'ForeName': 'Imran Khan', 'Initials': 'IK', 'LastName': 'Niazi', 'Affiliation': 'Center of Chiropractic Research New Zealand College of Chiropractic, Auckland 1060, New Zealand.'}, {'ForeName': 'Hamza Ghazanfar', 'Initials': 'HG', 'LastName': 'Toor', 'Affiliation': 'Faculty of Rehabilitation and Allied Sciences & Faculty of Engineering and Applied Sciences, Riphah International University, Islamabad 44000, Pakistan.'}, {'ForeName': 'Rasmus Bach', 'Initials': 'RB', 'LastName': 'Nedergaard', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, 9000 Aalborg, Denmark.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Shafique', 'Affiliation': 'Faculty of Rehabilitation and Allied Sciences & Faculty of Engineering and Applied Sciences, Riphah International University, Islamabad 44000, Pakistan.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Holt', 'Affiliation': 'Center of Chiropractic Research New Zealand College of Chiropractic, Auckland 1060, New Zealand.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Haavik', 'Affiliation': 'Center of Chiropractic Research New Zealand College of Chiropractic, Auckland 1060, New Zealand.'}, {'ForeName': 'Touqeer', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Neurobiology Laboratory, Department of Healthcare Biotechnology, Atta-ur-Rahman School of Applied Biosciences, National University of Sciences and Technology, Islamabad 44000, Pakistan.'}]",Brain sciences,['10.3390/brainsci10100663']
2936,32977710,Food Consumption and Emotions at a Salad Lunch Buffet in a Multisensory Environment.,"The food experience is multisensory and multisensory external stimuli may affect food choice and emotions. The objective of this study was to evaluate the effect of a multisensory eating environment on food choice, intake and the emotional states of the subjects in a salad lunch buffet setting. A total of 30 female subjects consumed a salad lunch twice in the multisensory laboratory. The two test conditions (control and multisensory condition with environmental stimuli) were randomized and the visits were scheduled one week apart. Subjects selected and ate a meal from a salad buffet including 14 food items and the intake of each item was weighed. They answered an online questionnaire about the meal and their emotional states (20 different emotion terms) after the lunch. There was no significant difference in the food consumption between the control and multisensory conditions. The subjects were very satisfied with their lunch for both study visits but the pleasantness of the eating environment was rated higher under the multisensory condition. In emotional terms, the subjects selected the term ""happy"" significantly more frequently under the multisensory condition compared with the control. In conclusion, the multisensory eating environment in this study was not related to food intake but may be associated with positive emotions. The effect of the eating environment on food choice and experience deserves further study with a larger study population in a real lunch restaurant setting.",2020,There was no significant difference in the food consumption between the control and multisensory conditions.,"['subjects in a salad lunch buffet setting', '30 female subjects consumed a salad lunch twice in the multisensory laboratory']","['eating environment', 'multisensory eating environment']","['food consumption', 'Food Consumption and Emotions']","[{'cui': 'C0453740', 'cui_str': 'Salad'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",30.0,0.0313404,There was no significant difference in the food consumption between the control and multisensory conditions.,"[{'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Hoppu', 'Affiliation': 'Functional Foods Forum, University of Turku, 20014 Turku, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Puputti', 'Affiliation': 'Functional Foods Forum, University of Turku, 20014 Turku, Finland.'}, {'ForeName': 'Saila', 'Initials': 'S', 'LastName': 'Mattila', 'Affiliation': 'Functional Foods Forum, University of Turku, 20014 Turku, Finland.'}, {'ForeName': 'Marjaana', 'Initials': 'M', 'LastName': 'Puurtinen', 'Affiliation': 'Department of Teacher Education, University of Turku, 20014 Turku, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Sandell', 'Affiliation': 'Functional Foods Forum, University of Turku, 20014 Turku, Finland.'}]","Foods (Basel, Switzerland)",['10.3390/foods9101349']
2937,32978352,"Post-operative pain after laparoscopic ventral hernia repair, the impact of mesh soakage with bupivacaine solution versus normal saline solution: A randomised controlled trial (HAPPIEST Trial).","Background and Aims
Early postoperative pain after laparoscopic ventral hernia repair remains a concern for patients. Local application of anaesthetic agent in the surgical dissection area can potentially overcome this problem. The objective of this study was to evaluate the impact of soaking mesh in 0.5% bupivacaine solution as compared to normal saline solution on the post-operative pain.
Methodology
We conducted a parallel-design double-blind randomised controlled trial. Adult patients with uncomplicated ventral abdominal wall hernias were included in the trial. Mesh was soaked in 0.5% solution of bupivacaine before application in patients in the intervention arm, whereas it was soaked in normal saline solution for patients in the control arm. Post-operative pain was assessed by trained staff at 6 h and 24 h from surgery. It was graded on visual analogue scale (VAS) from 0 to 10.
Results
Trial was conducted from 16 November, 2015, to 15 September, 2017. During the study period, a total of 114 patients were randomised. Nine patients were excluded after randomisation. A total of 55 patients were analysed in the intervention arm and 50 patients were analysed in the control arm. Mean pain score at VAS at 6 h after laparoscopic ventral hernia repair in the intervention arm was 5.05 ± 1.2, whereas in the control arm, it was 5.54 ± 1.1 and the difference was statistically significant (P = 0.03-independent sample t-test). Mean pain score at VAS at 24 h after laparoscopic ventral hernia repair in the intervention arm was 3.16 ± 1.2, whereas in the control arm, it was 3.58 ± 1.4 and the difference was not statistically significant (P = 0.11-independent sample t-test).
Conclusion
Soakage of mesh in 0.5% bupivacaine solution before application in laparoscopic ventral hernia repair significantly reduces early post-operative pain.
Trial Registration
Trial was registered with clinicaltrials. gov (NCT03035617)URL: https://clinicaltrials. gov.",2020,"Mean pain score at VAS at 6 h after laparoscopic ventral hernia repair in the intervention arm was 5.05 ± 1.2, whereas in the control arm, it was 5.54 ± 1.1 and the difference was statistically significant (P = 0.03-independent sample t-test).","['114 patients were randomised', 'Adult patients with uncomplicated ventral abdominal wall hernias', 'A total of 55 patients were analysed in the intervention arm and 50 patients were analysed in the control arm', '16 November, 2015, to 15 September, 2017', 'patients']","['bupivacaine', 'bupivacaine solution versus normal saline solution', 'laparoscopic ventral hernia repair', 'bupivacaine solution', 'normal saline solution']","['visual analogue scale (VAS', 'Mean pain score', 'Post-operative pain']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0019326', 'cui_str': 'Hernia of anterior abdominal wall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",114.0,0.724817,"Mean pain score at VAS at 6 h after laparoscopic ventral hernia repair in the intervention arm was 5.05 ± 1.2, whereas in the control arm, it was 5.54 ± 1.1 and the difference was statistically significant (P = 0.03-independent sample t-test).","[{'ForeName': 'Tabish', 'Initials': 'T', 'LastName': 'Chawla', 'Affiliation': 'Department of Surgery, Aga Khan University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Noman', 'Initials': 'N', 'LastName': 'Shahzad', 'Affiliation': 'Department of Surgery, Queen Elizabeth the Queen Mother Hospital, East Kent Hospitals University NHS Foundation Trust, United Kingdom.'}, {'ForeName': 'Khabir', 'Initials': 'K', 'LastName': 'Ahmad', 'Affiliation': 'Department of Surgery, Aga Khan University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Jehangir Farman', 'Initials': 'JF', 'LastName': 'Ali', 'Affiliation': 'Department of Surgery, Aga Khan University Hospital, Karachi, Pakistan.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_50_19']
2938,32979417,Serum lipids and their association with birth weight in metformin and insulin treated patients with gestational diabetes.,"AIMS
To compare the effects of metformin and insulin treatment on maternal serum lipids in patients with gestational diabetes (GDM), and to analyse the associations between individual lipids and birth weight (BW).
METHODS
This is a secondary analysis of a randomized trial comparing metformin (n = 110) and insulin (n = 107) treatment of GDM. Fasting serum lipidome was measured at baseline (the time of diagnosis, mean 30 gestational weeks, gw) and at 36 gw using nuclear magnetic resonance spectroscopy.
RESULTS
Total and VLDL triglycerides, and VLDL cholesterol increased from baseline to 36 gw in both treatment groups. The rise in triglycerides was greater in the metformin treated patients (p < 0.01). Baseline total and VLDL triglycerides, VLDL cholesterol, and apolipoprotein B to A-1 ratio (apoB/apoA-1) associated positively with BW, more strongly in the metformin group. Among patients in the highest baseline VLDL cholesterol or apoB/apoA-1 quartile, those treated with insulin had lower BWs than those treated with metformin (p < 0.03).
CONCLUSION
Compared to insulin, metformin treatment of GDM led to higher maternal serum concentrations of triglyceride-rich lipoproteins. Especially triglycerides and cholesterol in VLDL were positively associated with BW. Women with high VLDL cholesterol or high apoB/apoA-1 may benefit from insulin treatment over metformin with respect to offspring BW.",2020,The rise in triglycerides was greater in the metformin treated patients (p<0.01).,"['treated patients with gestational diabetes', 'patients with gestational diabetes (GDM', 'Women with high VLDL cholesterol or high apoB/apoA-1']","['metformin and insulin treatment', 'metformin', 'insulin, metformin', 'metformin and insulin', 'GDM']","['maternal serum concentrations of triglyceride-rich lipoproteins', 'Fasting serum lipidome', 'rise in triglycerides', 'Total and VLDL triglycerides and VLDL cholesterol', 'Especially triglycerides and cholesterol in VLDL', 'Serum lipids and their association with birth weight', 'individual lipids and birth weight (BW', 'Baseline total and VLDL triglycerides and VLDL cholesterol, and apolipoprotein B to A-1 ratio (apoB/apoA-1', 'maternal serum lipids']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C4727084', 'cui_str': 'Lipidome'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0078207', 'cui_str': 'Very low density lipoprotein triglyceride'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}]",,0.0260123,The rise in triglycerides was greater in the metformin treated patients (p<0.01).,"[{'ForeName': 'Mikael S', 'Initials': 'MS', 'LastName': 'Huhtala', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Turku, 20014 Turku, Finland; Department of Obstetrics and Gynecology, Turku University Hospital, Kiinamyllynkatu 4-8, 20521 Turku, Finland. Electronic address: misahu@utu.fi.'}, {'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Tertti', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Turku, 20014 Turku, Finland; Department of Obstetrics and Gynecology, Turku University Hospital, Kiinamyllynkatu 4-8, 20521 Turku, Finland.'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Rönnemaa', 'Affiliation': 'Department of Medicine, University of Turku, 20014 Turku, Finland; Department of Medicine, Turku University Hospital, Kiinamyllynkatu 4-8, 20521 Turku, Finland.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108456']
2939,32985108,A Novel Approach to Assess Metabolic Flexibility Overnight in a Whole-Body Room Calorimeter.,"OBJECTIVE
This study aimed to investigate a novel approach for determining the effects of energy-standardized dinner meals (high-fat and low-fat) on respiratory exchange ratio (RER) dynamics and metabolic flexibility.
METHODS
Using a randomized crossover study design, energy expenditure, RER, and macronutrient oxidation rates were assessed in response to a single dinner meal during an overnight stay in a whole-body room calorimeter. Eight healthy adults completed two overnight chamber stays while fed either a high-fat (60% fat, 20% carbohydrate [CHO], 20% protein; food quotient [FQ] = 0.784) or low-fat (20% fat, 60% CHO, 20% protein; FQ = 0.899) dinner containing 40% of daily energy requirements.
RESULTS
Following the low-fat meal, CHO oxidation first increased before decreasing, resulting in a 12-hour RER:FQ ratio close to 1.0 (0.986 ± 0.019, P = 0.06) and therefore resulting in a 12-hour equilibrated fat balance (29 ± 76 kcal/12 hours). Following the high-fat meal, participants had a RER:FQ ratio above 1.0 (1.061 ± 0.017, P < 0.01), resulting in a significant positive 12-hour fat balance of 376 ± 142 kcal/12 hours. Various RER trajectory parameters were significantly different following the high-fat and low-fat meals.
CONCLUSIONS
This proof-of-concept study provides an alternative approach to quantify metabolic flexibility in response to a high-fat dinner and it can be used to derive indexes of metabolic flexibility, such as the 12-hour RER:FQ ratio or the 12-hour fat balance.",2020,"Various RER trajectory parameters were significantly different following the high-fat and low-fat meals.
",['Eight healthy adults'],"['overnight chamber stays while fed either a high-fat (60% fat, 20% carbohydrate [CHO], 20% protein; food quotient [FQ]\u2009=\u20090.784) or low-fat', 'energy-standardized dinner meals (high-fat and low-fat']","['RER:FQ ratio', 'energy expenditure, RER, and macronutrient oxidation rates', 'CHO oxidation first', 'Metabolic Flexibility', 'respiratory exchange ratio (RER) dynamics and metabolic flexibility']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",8.0,0.0315199,"Various RER trajectory parameters were significantly different following the high-fat and low-fat meals.
","[{'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'McDougal', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Marlatt', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ravussin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22982']
2940,32985114,Randomized Controlled Trial of Behavioral Weight Loss and Stepped Care for Binge-Eating Disorder: 12-Month Follow-up.,"OBJECTIVE
This study aimed to examine longer-term effects of behavioral weight loss (BWL) and Stepped Care for binge-eating disorder and obesity through 12-month follow-up after completing treatments.
METHODS
A total of 191 patients with binge-eating disorder/obesity were randomized to 6 months of BWL (n = 39) or Stepped Care (n = 152). Within Stepped Care, patients began BWL (1 month), treatment responders continued BWL, nonresponders switched to cognitive behavioral therapy, and all were randomized (double-blind) to weight-loss medication or placebo (5 months). Patients were independently assessed throughout/after treatment and at 6- and 12-month follow-ups.
RESULTS
Intent-to-treat analyses of remission rates revealed that BWL and Stepped Care did not differ significantly at posttreatment (74.4% vs. 66.5%), 6-month follow-up (38.2% vs. 33.3%), or 12-month follow-up (44.7% vs. 41.0%). Mixed models of binge-eating frequency indicated significant reductions through posttreatment but no significant changes or differences between BWL and Stepped Care during follow-up. Mixed models revealed significant weight loss with no differences between BWL and Stepped Care (5.1% vs. 5.8%) at posttreatment and significant time effects (larger percent weight loss at 6-month than at 12-month follow-up) with no differences between BWL and Stepped Care (-5.1% vs. -5.2% and -3.4% vs. -5.0%, respectively).
CONCLUSIONS
Binge-eating improvements and weight loss produced by BWL and adaptive Stepped Care did not differ significantly 12 months after completing treatments.",2020,Mixed models of binge-eating frequency indicated significant reductions through posttreatment but no significant changes or differences between BWL and Stepped Care during follow-up.,"['Binge-Eating Disorder', '191 patients with binge-eating disorder/obesity']","['Behavioral Weight Loss and Stepped Care', 'BWL', 'Stepped Care', 'weight-loss medication or placebo', 'behavioral weight loss (BWL) and Stepped Care', 'cognitive behavioral therapy']","['weight loss', 'BWL and Stepped Care']","[{'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",191.0,0.0847065,Mixed models of binge-eating frequency indicated significant reductions through posttreatment but no significant changes or differences between BWL and Stepped Care during follow-up.,"[{'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Grilo', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Marney A', 'Initials': 'MA', 'LastName': 'White', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ivezaj', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22975']
2941,32985119,Energy Expenditure and Macronutrient Oxidation in Response to an Individualized Nonshivering Cooling Protocol.,"OBJECTIVE
This study aimed to describe the energy expenditure (EE) and macronutrient oxidation response to an individualized nonshivering cold exposure in young healthy adults.
METHODS
Two different groups of 44 (study 1: 22.1 [SD 2.1] years old, 25.6 [SD 5.2] kg/m 2 , 34% men) and 13 young healthy adults (study 2: 25.6 [SD 3.0] years old, 23.6 [SD 2.4] kg/m 2 , 54% men) participated in this study. Resting metabolic rate (RMR) and macronutrient oxidation rates were measured by indirect calorimetry under fasting conditions in a warm environment (for 30 minutes) and in mild cold conditions (for 65 minutes, with the individual wearing a water-perfused cooling vest set at an individualized temperature adjusted to the individual's shivering threshold).
RESULTS
In study 1, EE increased in the initial stage of cold exposure and remained stable for the whole cold exposure (P < 0.001). Mean cold-induced thermogenesis (9.56 ± 7.9 kcal/h) was 13.9% ± 11.6% of the RMR (range: -14.8% to 39.9% of the RMR). Carbohydrate oxidation decreased during the first 30 minutes of the cold exposure and later recovered up to the baseline values (P < 0.01) in parallel to opposite changes in fat oxidation (P < 0.01). Results were replicated in study 2.
CONCLUSIONS
A 1-hour mild cold exposure individually adjusted to elicit maximum nonshivering thermogenesis induces a very modest increase in EE and a shift of macronutrient oxidation that may underlie a shift in thermogenic tissue activity.",2020,Carbohydrate oxidation decreased during the first 30 minutes of the cold exposure and later recovered up to the baseline values (P < 0.01) in parallel to opposite changes in fat oxidation (P < 0.01).,"['young healthy adults', 'Two different groups of 44 (study 1: 22.1\u2009\u2009[SD 2.1] years old, 25.6\u2009\u2009[SD 5.2] kg/m 2 , 34% men) and 13 young healthy adults (study 2: 25.6\u2009\u2009[SD 3.0] years old, 23.6\u2009\u2009[SD 2.4] kg/m 2 , 54% men) participated in this study']",['energy expenditure (EE) and macronutrient oxidation response'],"['Mean cold-induced thermogenesis', 'fat oxidation', 'Resting metabolic rate (RMR) and macronutrient oxidation rates', 'Carbohydrate oxidation', 'initial stage of cold exposure']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517631', 'cui_str': '2.4'}]","[{'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0231275', 'cui_str': 'Cold exposure'}]",,0.0334861,Carbohydrate oxidation decreased during the first 30 minutes of the cold exposure and later recovered up to the baseline values (P < 0.01) in parallel to opposite changes in fat oxidation (P < 0.01).,"[{'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Sanchez-Delgado', 'Affiliation': 'Promoting Fitness and Health Through Physical Activity Research Group, Sport and Health University Research Institute, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Juan M A', 'Initials': 'JMA', 'LastName': 'Alcantara', 'Affiliation': 'Promoting Fitness and Health Through Physical Activity Research Group, Sport and Health University Research Institute, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Acosta', 'Affiliation': 'Promoting Fitness and Health Through Physical Activity Research Group, Sport and Health University Research Institute, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Martinez-Tellez', 'Affiliation': 'Promoting Fitness and Health Through Physical Activity Research Group, Sport and Health University Research Institute, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Amaro-Gahete', 'Affiliation': 'Promoting Fitness and Health Through Physical Activity Research Group, Sport and Health University Research Institute, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Merchan-Ramirez', 'Affiliation': 'Promoting Fitness and Health Through Physical Activity Research Group, Sport and Health University Research Institute, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Löf', 'Affiliation': 'Department of Biosciences and Nutrition, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Idoia', 'Initials': 'I', 'LastName': 'Labayen', 'Affiliation': ""Institute for Innovation and Sustainable Development in Food Chain, Navarra's Health Research Institute, Department of Health Sciences, Public University of Navarra, Pamplona, Spain.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ravussin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Jonatan R', 'Initials': 'JR', 'LastName': 'Ruiz', 'Affiliation': 'Promoting Fitness and Health Through Physical Activity Research Group, Sport and Health University Research Institute, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22972']
2942,32980290,Bempedoic acid safety analysis: Pooled data from four phase 3 clinical trials.,"BACKGROUND
An ongoing need exists for safe and effective lipid-lowering therapies (LLTs) for patients unable to achieve desired lipid levels with current treatment options.
OBJECTIVE
The objective of this study was to describe the safety profile of bempedoic acid, an oral, first-in-class, adenosine triphosphate (ATP)-citrate lyase inhibitor that significantly reduces low-density lipoprotein cholesterol (LDL-C) levels by 17.4%-28.5% vs placebo.
METHODS
This was a pooled analysis of four phase 3, randomized (2:1), double-blind, placebo-controlled studies in patients with hypercholesterolemia who required additional LDL-C lowering, despite stable maximally-tolerated LLT. Patients received 180 mg of bempedoic acid (n = 2424) or placebo (n = 1197) once daily for 12 to 52 weeks. Assessments included treatment-emergent adverse events (TEAEs) and clinical laboratory tests.
RESULTS
Of 3621 patients (the median drug exposure: 363 days), exposure-adjusted TEAE rates were 87.1/100 and 82.9/100 person-years (PY) for bempedoic acid and placebo, respectively. No single TEAE influenced the difference in rates. TEAEs leading to discontinuation occurred at rates of 13.4/100 and 8.9/100 PY for bempedoic acid vs placebo, with the most common cause being myalgia, which occurred less frequently with bempedoic acid vs placebo (1.5/100 vs 2.0/100 PY). Rates of myalgia and muscle weakness were comparable vs placebo. Bempedoic acid was associated with mild increases in blood urea nitrogen, creatinine, and uric acid and decreases in hemoglobin. These laboratory abnormalities were apparent by week 4, stable over time, and reversible after treatment cessation. Gout incidence was 1.6/100 vs 0.5/100 PY in the bempedoic acid vs placebo groups. New-onset diabetes/hyperglycemia occurred less frequently with bempedoic acid vs placebo (4.7/100 vs 6.4/100 PY). The safety profile was consistent across subgroups.
CONCLUSIONS
Bempedoic acid is generally safe and well tolerated among patients with hypercholesterolemia who require additional LLT.",2020,"TEAEs leading to discontinuation occurred at rates of 13.4/100 and 8.9/100 PY for bempedoic acid vs placebo, with the most common cause being myalgia, which occurred less frequently with bempedoic acid vs placebo (1.5/100 vs 2.0/100 PY).","['patients with hypercholesterolemia who require additional LLT', 'patients with hypercholesterolemia who required additional LDL-C lowering, despite stable maximally-tolerated LLT', '3621 patients (the median drug exposure']","['bempedoic acid', 'Bempedoic acid', 'placebo', 'bempedoic acid vs placebo']","['exposure-adjusted TEAE rates', 'Rates of myalgia and muscle weakness', 'treatment-emergent adverse events (TEAEs) and clinical laboratory tests', 'low-density lipoprotein cholesterol (LDL-C) levels', 'Gout incidence', 'blood urea nitrogen, creatinine, and uric acid and decreases in hemoglobin', 'New-onset diabetes/hyperglycemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C3659310', 'cui_str': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",3621.0,0.637879,"TEAEs leading to discontinuation occurred at rates of 13.4/100 and 8.9/100 PY for bempedoic acid vs placebo, with the most common cause being myalgia, which occurred less frequently with bempedoic acid vs placebo (1.5/100 vs 2.0/100 PY).","[{'ForeName': 'Harold E', 'Initials': 'HE', 'LastName': 'Bays', 'Affiliation': 'Louisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky, USA. Electronic address: hbaysmd@outlook.com.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Banach', 'Affiliation': 'Department of Hypertension, Medical University of Łódź, Łódź, Poland.'}, {'ForeName': 'Alberico L', 'Initials': 'AL', 'LastName': 'Catapano', 'Affiliation': 'Department of Pharmacological and Biomolecular Sciences, University of Milan and Multimedica IRCCS, Milan, Italy.'}, {'ForeName': 'P Barton', 'Initials': 'PB', 'LastName': 'Duell', 'Affiliation': 'Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Antonio M', 'Initials': 'AM', 'LastName': 'Gotto', 'Affiliation': 'Houston Methodist Research Institute, Houston, Texas, USA; Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Leipzig, Germany.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Division of Endocrinology & Metabolism, Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'G B John', 'Initials': 'GBJ', 'LastName': 'Mancini', 'Affiliation': 'Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Department of Primary Care and Public Health, Imperial Centre for Cardiovascular Disease Prevention, Imperial College London, London, UK.'}, {'ForeName': 'LeAnne T', 'Initials': 'LT', 'LastName': 'Bloedon', 'Affiliation': 'Esperion Therapeutics, Inc., Ann Arbor, Michigan, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sasiela', 'Affiliation': 'Esperion Therapeutics, Inc., Ann Arbor, Michigan, USA.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Esperion Therapeutics, Inc., Ann Arbor, Michigan, USA.'}, {'ForeName': 'Christie M', 'Initials': 'CM', 'LastName': 'Ballantyne', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2020.08.009']
2943,32980725,Radiomic features of magnetic resonance images as novel preoperative predictive factors of bone invasion in meningiomas.,"PURPOSE
Bone invasion in meningiomas is a prognostic determinant, and a priori knowledge may alter surgical techniques. Here, we aim to predict bone invasion in meningiomas using radiomic signatures based on preoperative, contrast-enhanced T1-weighted (T1C) and T2-weighted (T2) magnetic resonance imaging (MRI).
METHODS
In this retrospective study, 490 patients diagnosed with meningiomas, including WHO grade I (448cases), grade II (38cases), and grade III (4cases), were enrolled and 213 out of 490 cases (43.5 %) had bone invasion. The patients were randomly divided into training (n = 343) and test (n = 147) datasets at a 7:3 ratio. For each patient, 1227 radiomic features were extracted from T1C and T2, respectively. Spearman's correlation and least absolute shrinkage and selection operator (LASSO) regression analyses were performed to select the most informative features. Subsequently, a 5-fold cross-validation was used to compare the performance of different classification algorithms, and logistic regression was chosen to predict the risk of bone invasion.
RESULTS
Eight radiomic features were selected from T1C and T2 respectively, and three models were built using radiomic features. The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722 [95 % CI, 0.668-0.776] and in the test datasets of 0.715 [95 % CI, 0.632-0.798] and 0.713 [95 % CI, 0.628-0.798], respectively.
CONCLUSIONS
The radiomic model may aid clinicians with preoperative prediction of bone invasion by meningiomas, which can help in predicting prognosis and devising surgical strategies.",2020,"The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722","['490 patients diagnosed with meningiomas, including WHO grade I (448cases), grade II (38cases), and grade III (4cases), were enrolled and 213 out of 490 cases (43.5 %) had bone invasion', 'bone invasion in meningiomas']","['magnetic resonance images', 'radiomic signatures based on preoperative, contrast-enhanced T1-weighted (T1C) and T2-weighted (T2) magnetic resonance imaging (MRI']",['risk of bone invasion'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025286', 'cui_str': 'Meningioma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]","[{'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]",490.0,0.0309829,"The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China; Key Laboratory of Medical Imaging of Gansu Province, Lanzhou, China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Philips Healthcare, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Yuntai', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Guojin', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Junlin', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China. Electronic address: lzuzjl601@163.com.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109287']
2944,32986940,Efficacy of Extracorporeal Shockwave Therapy on Cervical Myofascial Pain Following Neck Dissection Surgery: A Randomized Controlled Trial.,"OBJECTIVE
To investigate the efficacy of extracorporeal shockwave therapy (ESWT) on cervical myofascial pain following neck dissection in reducing pain and improving cervical range of motion (ROM).
METHODS
Forty-six patients with cervical myofascial pain following neck dissection surgery were recruited and subdivided at random into two equal groups. The ESWT group received ESWT once a week for 4 weeks (0.25 mL/mm2, 1,000 shocks) and a topical non-steroidal anti-inflammatory drug (3 times/day for 4 weeks). The control group received only topical NSAID. The pain assessment was done by using the visual analog scale (VAS) and pressure algometry. A cervical ROM device was used for the assessment of the lateral flexion and rotation of the neck ROM on both sides. All measurements were collected at baseline, 2 weeks, and 4 weeks.
RESULTS
The ESWT group revealed a significant improvement in all parameters at post I and post II than did the control group (p>0.001), that revealed a statistical decrease only in the VAS score at post I without any statistical difference in the pain threshold and neck ROM. However, there were statistical differences in all parameters at post II compared to those at pre-treatment and post I (p<0.001).
CONCLUSION
As a confirmation of the efficacy of ESWT in cervical myofascial pain control following neck dissection, we observed better results with no side effects in the ESWT group (Clinical Trial Registry No. PACTR202002648274347).",2020,"The ESWT group revealed a significant improvement in all parameters at post I and post II than did the control group (p>0.001), that revealed a statistical decrease only in the VAS score at post I without any statistical difference in the pain threshold and neck ROM.","['cervical myofascial pain control following neck dissection', 'Methods\n\n\nForty-six patients with cervical myofascial pain following neck dissection surgery']","['Extracorporeal Shockwave Therapy', 'topical non-steroidal anti-inflammatory drug', 'extracorporeal shockwave therapy (ESWT', 'Neck Dissection Surgery', 'topical NSAID', 'ESWT']","['pain assessment', 'cervical myofascial pain', 'VAS score', 'visual analog scale (VAS) and pressure algometry', 'pain threshold and neck ROM', 'Cervical Myofascial Pain', 'pain and improving cervical range of motion (ROM']","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1319209', 'cui_str': 'Neck joint - range of movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",46.0,0.0674619,"The ESWT group revealed a significant improvement in all parameters at post I and post II than did the control group (p>0.001), that revealed a statistical decrease only in the VAS score at post I without any statistical difference in the pain threshold and neck ROM.","[{'ForeName': 'FatmaAlzahraa Hassan', 'Initials': 'FH', 'LastName': 'Kamel', 'Affiliation': 'Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Buraidah, Saudi Arabia.'}, {'ForeName': 'Maged', 'Initials': 'M', 'LastName': 'Basha', 'Affiliation': 'Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Buraidah, Saudi Arabia.'}, {'ForeName': 'Ashwag', 'Initials': 'A', 'LastName': 'Alsharidah', 'Affiliation': 'Department of Physiology, College of Medicine, Qassim University, Buraidah, Saudi Arabia.'}, {'ForeName': 'Islam Mohamed', 'Initials': 'IM', 'LastName': 'Hewidy', 'Affiliation': 'Department of Physical Therapy, New York Medical College, Valhalla, NY, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ezzat', 'Affiliation': 'Department of Physical Therapy for Orthopedics, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nancy Hassan', 'Initials': 'NH', 'LastName': 'Aboelnour', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}]",Annals of rehabilitation medicine,['10.5535/arm.20055']
2945,32986941,"Effects of Extracorporeal Shockwave Therapy on Improvements in Lymphedema, Quality of Life, and Fibrous Tissue in Breast Cancer-Related Lymphedema.","OBJECTIVE
To evaluate the effects of extracorporeal shockwave therapy (ESWT) on improving lymphedema, quality of life, and fibrous tissue in patients with stage 2 lymphedema.
METHODS
Breast cancer-related lymphedema patients referred to the rehabilitation center were recruited. We enrolled stage 2 lymphedema patients who had firmness of the skin at their forearm, a circumference difference of more than 2 cm between each arm, or a volume difference between upper extremities greater than 200 mL, confirmed by lymphoscintigraphy. The patients were randomly divided into the ESWT group and the control group. ESWT was performed for 3 weeks (two sessions per week); both groups received complex decongestive physical therapy. All patients were evaluated at baseline and at 3 weeks after treatment. The measurements performed included visual analog scale score, volume, circumference, QuickDASH (Quick Disabilities of the Arm, Shoulder and Hand) score, bioelectrical impedance, and skin thickness.
RESULTS
The patients in both groups (n=15 in each group) completed the 3-week therapy experiment. No significant differences were observed in demographic characteristics between groups. After the 3-week treatment period, improvement was noted in the circumference difference below the elbow, volume, ratio of extracellular water to total body water, and skin thickness in the ESWT group. A significant difference was found in all the above-mentioned areas except in circumference below the elbow in the ESWT group.
CONCLUSION
ESWT reduced edema and skin fibrosis without significant complications. Therefore, ESWT can be used together with complex decongestive physical therapy for treating lymphedema.",2020,"A significant difference was found in all the above-mentioned areas except in circumference below the elbow in the ESWT group.
","['enrolled stage 2 lymphedema patients who had firmness of the skin at their forearm, a circumference difference of more than 2 cm between each arm, or a volume difference between upper extremities greater than 200 mL, confirmed by lymphoscintigraphy', 'patients with stage 2 lymphedema', 'Methods\n\n\nBreast cancer-related lymphedema patients referred to the rehabilitation center were recruited']","['Extracorporeal Shockwave Therapy', 'complex decongestive physical therapy', 'ESWT', 'extracorporeal shockwave therapy (ESWT']","['edema and skin fibrosis', 'lymphedema, quality of life, and fibrous tissue', 'circumference difference below the elbow, volume, ratio of extracellular water to total body water, and skin thickness', 'Lymphedema, Quality of Life, and Fibrous Tissue in Breast Cancer-Related Lymphedema', 'visual analog scale score, volume, circumference, QuickDASH (Quick Disabilities of the Arm, Shoulder and Hand) score, bioelectrical impedance, and skin thickness', 'demographic characteristics']","[{'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0412375', 'cui_str': 'Radioisotope scan of lymphatic system'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0263008', 'cui_str': 'Fibrosis of the skin'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0225331', 'cui_str': 'Fibrous tissue'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",,0.0194452,"A significant difference was found in all the above-mentioned areas except in circumference below the elbow in the ESWT group.
","[{'ForeName': 'Kyeong Woo', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Sang Beom', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Jong Hwa', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Young Sam', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Dong-A University College of Medicine, Busan, Korea.'}]",Annals of rehabilitation medicine,['10.5535/arm.19213']
2946,32986939,Motor Function in the Late Phase After Stroke: Stroke Survivors' Perspective.,"OBJECTIVE
To examine the association between observer-assessed functional status and perceived recovery in the late phase after stroke. The study also aimed to determine whether observer-assessed functional improvements as a result of horse-riding therapy (H-RT) are related to enhanced perception of stroke recovery.
METHODS
This is a descriptive correlational study using data derived from a three-armed randomized controlled trial in which 123 individuals were enrolled, among whom 43 received H-RT for 12 weeks. The measures included the Modified Motor Assessment Scale, Berg Balance Scale, Timed Up and Go, timed 10-m walk, and perceived recovery from stroke indicated by item #9 in the Stroke Impact Scale (version 2.0). Spearman rank order correlation (rs) was used in the analyses.
RESULTS
There were moderate to strong positive or negative correlations between all four observer-assessed motor variables and participants' ratings of perceived late-phase stroke recovery at trial entrance, ranging from rs=-0.49 to rs=0.54 (p<0.001). The results of the correlational analyses of variable changes showed that, after the end of the H-RT intervention, both self-selected and fast gait speed improvement were significantly correlated with increments in self-rated stroke recovery (rs=-0.41, p=0.01 and rs=-0.38, p=0.02, respectively).
CONCLUSION
This study provided data supporting the association between individual ratings of self-perceived recovery after stroke and observer-assessed individual motor function. The results further demonstrate that enhancement in perceived stroke recovery after completing the intervention was associated with objectively measured gains in both self-selected and fast gait speed.",2020,The results further demonstrate that enhancement in perceived stroke recovery after completing the intervention was associated with objectively measured gains in both self-selected and fast gait speed.,"['123 individuals were enrolled, among whom 43 received H-RT for 12 weeks']",['horse-riding therapy (H-RT'],"['self-rated stroke recovery', 'stroke recovery', 'self-selected and fast gait speed improvement', 'Modified Motor Assessment Scale, Berg Balance Scale, Timed Up and Go, timed 10-m walk, and perceived recovery from stroke indicated by item #9 in the Stroke Impact Scale', 'Motor Function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451321', 'cui_str': 'Motor assessment scale'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",123.0,0.0336275,The results further demonstrate that enhancement in perceived stroke recovery after completing the intervention was associated with objectively measured gains in both self-selected and fast gait speed.,"[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Bunketorp-Käll', 'Affiliation': 'Center for Brain Repair, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Pekna', 'Affiliation': 'Center for Brain Repair, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Pekny', 'Affiliation': 'Center for Brain Repair, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Samuelsson', 'Affiliation': 'Center for Brain Repair, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Blomstrand', 'Affiliation': 'Center for Brain Repair, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Center for Brain Repair, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}]",Annals of rehabilitation medicine,['10.5535/arm.20060']
2947,32991361,"The Effect of ACDF or Arthroplasty on Cervicogenic Headaches: A Post Hoc Analysis of a Prospective, Multicenter Study With 10-Year Follow-up.","STUDY DESIGN
This was a post hoc analysis of a prospective FDA-IDE study.
OBJECTIVE
The purpose of this study is to determine the effectiveness of a 2-level anterior cervical discectomy and fusion (ACDF) or cervical disk arthroplasty (CDA) at relieving headaches associated with cervical radiculopathy or myelopathy at 10 years postoperative.
BACKGROUND
To our knowledge, there is no large, prospective study that has examined the efficacy of cervical spine surgery for relieving headaches associated with radiculopathy or myelopathy at 10 years postoperative.
MATERIALS AND METHODS
This was a post hoc analysis of a prospective FDA-IDE study for the Prestige LP versus ACDF for radiculopathy or myelopathy due to 2 levels. Preoperatively and out to 10 years, their Neck Disability Index documented if they had headaches (0: no headaches; 1: infrequent slight; 2: infrequent moderate; 3: frequent moderate; 4: frequent severe; 5: nearly constant).
RESULTS
Three hundred ninety-seven patients were randomized to CDA (209) or ACDF (188). Preoperatively 86% had headaches and 55.9% (52.2% of CDA, 60.1% of ACDFs) had frequent moderate, severe, or nearly constant headache (grades 3-5). By 6 weeks postoperative, 64.4% had headaches and only 12.5% had grades 3-5 headaches (9.3% of CDA and 16% of ACDFs). The benefit lasted to the 10-year follow-up such that 60.3% had any headaches and 16.8% had grades 3-5 headaches (10.9% CDA; 24.3% ACDF).
CONCLUSIONS
These results suggest that 86% of patients with radiculopathy or myelopathy complain of headaches preoperatively, with 55.9% having frequent or constant, moderate to severe headaches (grades 3-5). By 6 weeks postoperative, only 12.5% had grades 3-5 headaches. At 10-year follow-up, 16.8% had grades 3-5 headaches. Both arthroplasty and ACDF are often effective at alleviating headaches associated with radiculopathy or myelopathy.",2020,"By 6 weeks postoperative, 64.4% had headaches and only 12.5% had grades 3-5 headaches (9.3% of CDA and 16% of ACDFs).","['Three hundred ninety-seven patients', 'Cervicogenic Headaches']","['CDA', 'cervical spine surgery', '2-level anterior cervical discectomy and fusion (ACDF) or cervical disk arthroplasty (CDA', 'ACDF']","['grades 3-5 headaches', 'severe headaches', 'Neck Disability Index', 'headaches', 'frequent moderate, severe, or nearly constant headache']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458101', 'cui_str': 'Cervicogenic headache'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C4552416', 'cui_str': 'ACDF'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]",397.0,0.0194181,"By 6 weeks postoperative, 64.4% had headaches and only 12.5% had grades 3-5 headaches (9.3% of CDA and 16% of ACDFs).","[{'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Lombardi', 'Affiliation': 'Department of Orthopaedic Surgery, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Vivas', 'Affiliation': 'Department of Orthopaedic Surgery, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Gornet', 'Affiliation': 'The Orthopaedic Center of St Louis, Chesterfield, MO.'}, {'ForeName': 'Todd H', 'Initials': 'TH', 'LastName': 'Lanman', 'Affiliation': 'Spinal Neurosuergery, Department of Neurosurgery, UCLA David Geffen School of Medicine, Cedars Sinai Institute for Spinal Disorders.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'McConnell', 'Affiliation': 'Lehigh Valley Health Network, Allentown, PA.'}, {'ForeName': 'Randall F', 'Initials': 'RF', 'LastName': 'Dryer', 'Affiliation': 'Central Texas Spine Institute, Austin, TX.'}, {'ForeName': 'J Kenneth', 'Initials': 'JK', 'LastName': 'Burkus', 'Affiliation': 'Hughston Clinic Main, Columbus, GA.'}, {'ForeName': 'K Daniel', 'Initials': 'KD', 'LastName': 'Riew', 'Affiliation': 'Department of Orthopaedic Surgery, Columbia University Medical Center, New York, NY.'}]",Clinical spine surgery,['10.1097/BSD.0000000000001087']
2948,32994202,Male serrate-legged treefrogs adjust competition strategies according to visual or chemical cues from females.,"There is increasing evidence that many anurans use multimodal cues to detect, discriminate and/or locate conspecifics and thus modify their behaviors. To date, however, most studies have focused on the roles of multimodal cues in female choice or male-male interactions. In the present study, we conducted an experiment to investigate whether male serrate-legged small treefrogs ( Kurixalus odontotarsus ) used visual or chemical cues to detect females and thus altered their competition strategies in different calling contexts. Three acoustic stimuli (advertisement calls, aggressive calls and compound calls) were broadcast in a randomized order after a spontaneous period to focal males in one of four treatment groups: combined visual and chemical cues of a female, only chemical cues, only visual cues and a control (with no females). We recorded the vocal responses of the focal males during each 3 min period. Our results demonstrate that males reduce the total number of calls in response to the presence of females, regardless of how they perceived the females. In response to advertisement calls and compound calls, males that perceived females through chemical cues produced relatively fewer advertisement calls but more aggressive calls. In addition, they produced relatively more aggressive calls during the playback of aggressive calls. Taken together, our study suggests that male K odontotarsus adjust their competition strategies according to the visual or chemical cues of potential mates and highlights the important role of multisensory cues in male frogs' perception of females.",2020,"There is increasing evidence that many anurans use multimodal cues to detect, discriminate and/or locate conspecifics and thus modify their behaviors.","['female choice or male-male interactions', ""male frogs' perception of females""]","['male serrate-legged small treefrogs ( Kurixalus odontotarsus ) used visual or chemical cues', 'acoustic stimuli (advertisement calls, aggressive calls and compound calls) were broadcast', 'combined visual and chemical cues of a female, only chemical cues, only visual cues and a control (with no females']","['vocal responses', 'aggressive calls']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0003459', 'cui_str': 'Toads and Frogs'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0327058', 'cui_str': 'Treefrog'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",,0.0239534,"There is increasing evidence that many anurans use multimodal cues to detect, discriminate and/or locate conspecifics and thus modify their behaviors.","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Deng', 'Affiliation': 'CAS Key Laboratory of Mountain Ecological Restoration and Bioresource Utilization & Ecological Restoration and Biodiversity Conservation Key Laboratory of Sichuan Province, Chengdu Institute of Biology, Chinese Academy of Sciences, Chengdu, 610041, China.'}, {'ForeName': 'Qiao-Ling', 'Initials': 'QL', 'LastName': 'He', 'Affiliation': 'College of Life Sciences, China West Normal University, Nanchong, 637000, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'CAS Key Laboratory of Mountain Ecological Restoration and Bioresource Utilization & Ecological Restoration and Biodiversity Conservation Key Laboratory of Sichuan Province, Chengdu Institute of Biology, Chinese Academy of Sciences, Chengdu, 610041, China.'}, {'ForeName': 'Bi-Cheng', 'Initials': 'BC', 'LastName': 'Zhu', 'Affiliation': 'CAS Key Laboratory of Mountain Ecological Restoration and Bioresource Utilization & Ecological Restoration and Biodiversity Conservation Key Laboratory of Sichuan Province, Chengdu Institute of Biology, Chinese Academy of Sciences, Chengdu, 610041, China.'}, {'ForeName': 'Tong-Liang', 'Initials': 'TL', 'LastName': 'Wang', 'Affiliation': 'Ministry of Education Key Laboratory for Ecology of Tropical Islands, College of Life Sciences, Hainan Normal University, Haikou, 570000, China.'}, {'ForeName': 'Ji-Chao', 'Initials': 'JC', 'LastName': 'Wang', 'Affiliation': 'Ministry of Education Key Laboratory for Ecology of Tropical Islands, College of Life Sciences, Hainan Normal University, Haikou, 570000, China.'}, {'ForeName': 'Jian-Guo', 'Initials': 'JG', 'LastName': 'Cui', 'Affiliation': 'CAS Key Laboratory of Mountain Ecological Restoration and Bioresource Utilization & Ecological Restoration and Biodiversity Conservation Key Laboratory of Sichuan Province, Chengdu Institute of Biology, Chinese Academy of Sciences, Chengdu, 610041, China cuijg@cib.ac.cn.'}]",The Journal of experimental biology,['10.1242/jeb.229245']
2949,32994227,Bridging Western and Indigenous knowledge through intercultural dialogue: lessons from participatory research in Mexico.,"Indigenous communities in Latin America and elsewhere have complex bodies of knowledge, but Western health services generally approach them as vulnerable people in need of external solutions. Intercultural dialogue recognises the validity and value of Indigenous standpoints, and participatory research promotes reciprocal respect for stakeholder input in knowledge creation.As part of their decades-long community-based work in Mexico's Guerrero State, researchers at the Centro de Investigación de Enfermedades Tropicales responded to the request from Indigenous communities to help them address poor maternal health. We present the experience from this participatory research in which both parties contributed to finding solutions for a shared concern. The aim was to open an intercultural dialogue by respecting Indigenous skills and customs, recognising the needs of health service stakeholders for scientific evidence.Three steps summarise the opening of intercultural dialogue. Trust building and partnership based on mutual respect and principles of cultural safety. This focused on understanding traditional midwifery and the cultural conflicts in healthcare for Indigenous women. A pilot randomised controlled trial was an opportunity to listen and to adjust the lexicon identifying and testing culturally coherent responses for maternal health led by traditional midwives. Codesign, evaluation and discussion happened during a full cluster randomised trial to identify benefits of supporting traditional midwifery on maternal outcomes. A narrative mid-term evaluation and cognitive mapping of traditional knowledge offered additional evidence to discuss with other stakeholders the benefits of intercultural dialogue. These steps are not mechanistic or invariable. Other contexts might require additional steps. In Guerrero, intercultural dialogue included recovering traditional midwifery and producing high-level epidemiological evidence of the value of traditional midwives, allowing service providers to draw on the strengths of different cultures.",2020,"Intercultural dialogue recognises the validity and value of Indigenous standpoints, and participatory research promotes reciprocal respect for stakeholder input in knowledge creation.","['maternal health led by traditional midwives', 'healthcare for Indigenous women']",[],[],"[{'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],[],,0.0304384,"Intercultural dialogue recognises the validity and value of Indigenous standpoints, and participatory research promotes reciprocal respect for stakeholder input in knowledge creation.","[{'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Sarmiento', 'Affiliation': 'CIET-PRAM, Department of Family Medicine, McGill University, Montreal, Quebec, Canada ivan.sarmiento@mail.mcgill.ca.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Zuluaga', 'Affiliation': 'Grupo de Estudios en Sistemas Tradicionales de Salud (GESTS), Universidad del Rosario, Bogotá, Cundinamarca, Colombia.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Paredes-Solís', 'Affiliation': 'Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Acapulco, Guerrero, México.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Chomat', 'Affiliation': 'CIET-PRAM, Department of Family Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Loutfi', 'Affiliation': 'CIET-PRAM, Department of Family Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Cockcroft', 'Affiliation': 'CIET-PRAM, Department of Family Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Andersson', 'Affiliation': 'CIET-PRAM, Department of Family Medicine, McGill University, Montreal, Quebec, Canada.'}]",BMJ global health,['10.1136/bmjgh-2020-002488']
2950,32978017,The impact of tooth-borne vs computer-guided bone-borne rapid maxillary expansion on pain and oral health-related quality of life: A parallel cohort study.,"INTRODUCTION
The primary aim of this study was to investigate and compare perceived pain intensity and oral health-related quality of life (OHRQOL) results during the activation phase of rapid maxillary expansion (RME), with tooth-borne and bone-borne devices. In addition, a secondary aim of this study was to evaluate the correlation between pain scales and the shortened Oral Health Impact Profile (OHIP-14) questionnaire.
METHODS
Thirty-six subjects (16 girls and 20 boys) with a mean age of 12.3 years (standard deviation, 0.82 years) were randomized into 2 groups. Group A received treatment with hyrax appliance, and group B received a computer-guided skeletal RME appliance. The same type of expansion screw and screw activation or expansion protocol were used. Two rating scales were used to assess the subject's pain during the activation phase of RME: a Graphic Rating Scale for Pain (GRS) and the Wong-Baker Faces Pain Scale (FPS). The OHIP-14 was used to evaluate the impact of RME on OHRQOL before the beginning of the treatment at day 3 and day 7 follow-ups. Painkillers were forbidden during the active phase of RME. Descriptive statistics, Student t test, and Pearson correlation were used. Significance was set at P ≤0.05.
RESULTS
A total of 36 subjects, divided into 2 groups, were treated in the study. Regarding the level of pain, the Student t test showed statistically significant higher pain in group B-although only on the first day of screw activation (GRS, P = 0.01; FPS, P <0.01). For the following days, there were no significant differences in pain levels between groups. The OHIP-14 showed no statistically significant difference at baseline (P = 0.32) and day 3 (P = 0.88) and day 7 (P = 0.85) follow-ups between the 2 groups. The Pearson correlation coefficient showed a statistically significant association between the 2 different scales of pain (GRS and FPS) but not a statistically significant correlation between GRS and FPS scales and OHIP-14.
CONCLUSIONS
A higher perceived pain intensity in the patients treated using a bone-borne computer-guided skeletal RME appliance was limited to the first day of screw activation. There were no statistically significant differences between the 2 types of treatment in terms of their impact on OHRQOL and no statistically significant correlation between pain scales and the OHIP-14 questionnaire.",2020,There were no statistically significant differences between the 2 types of treatment in terms of their impact on OHRQOL and no statistically significant correlation between pain scales and the OHIP-14 questionnaire.,"['Thirty-six subjects (16 girls and 20 boys) with a mean age of 12.3\xa0years (standard deviation, 0.82\xa0years', '36 subjects']","['computer-guided skeletal RME appliance', 'hyrax appliance', 'tooth-borne vs computer-guided bone-borne rapid maxillary expansion']","['pain and oral health-related quality of life', 'pain (GRS and FPS', 'Graphic Rating Scale for Pain (GRS) and the Wong-Baker Faces Pain Scale (FPS', 'GRS and FPS scales and OHIP-14', 'pain scales and the shortened Oral Health Impact Profile (OHIP-14) questionnaire', 'pain intensity and oral health-related quality of life (OHRQOL', 'pain levels', 'level of pain', 'pain intensity', 'pain scales and the OHIP-14 questionnaire', 'pain']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517482', 'cui_str': '0.82'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0441424', 'cui_str': 'Rapid maxillary expansion appliance'}, {'cui': 'C0020696', 'cui_str': 'Family Procaviidae'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",36.0,0.0363942,There were no statistically significant differences between the 2 types of treatment in terms of their impact on OHRQOL and no statistically significant correlation between pain scales and the OHIP-14 questionnaire.,"[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Altieri', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, School of Dentistry, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cassetta', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, School of Dentistry, Sapienza University of Rome, Rome, Italy. Electronic address: michele.cassetta@uniroma1.it.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2020.07.030']
2951,32978121,Does the effect of lifestyle intervention for individuals with diabetes vary by food insecurity status? A preplanned subgroup analysis of the REAL HEALTH randomized clinical trial.,"INTRODUCTION
We aimed to test the effectiveness of a lifestyle intervention (LI) for individuals with food insecurity and type 2 diabetes.
RESEARCH DESIGN AND METHODS
Adults with type 2 diabetes, body mass index ≥25 kg/m 2 (or ≥23 kg/m 2 if Asian), hemoglobin A1c of 6.5%-11.5% (48-97 mmol/mol) and who were willing to lose 5%-7% bodyweight were enrolled in REAL HEALTH-Diabetes. This practice-based randomized clinical trial compared LI (delivered inperson or by telephone) with medical nutrition therapy (MNT) on weight loss at 6 and 12 months. Two or more affirmative responses on the six-item US Department of Agriculture Food Security Survey Module indicated food insecurity. In this prespecified subgroup analysis, we tested using linear mixed effects models whether the intervention effect varied by food security status.
RESULTS
Of 208 participants, 13% were food insecure. Those with food insecurity were more likely to be racial/ethnic minorities (p<0.001) and have lower education (p<0.001). LI, versus MNT, led to greater weight loss at 6 months (5.1% lost vs 1.1% lost; p<0.0001) and 12 months (4.7% lost vs 2.0% lost; p=0.0005). The intervention effect was similar regardless of food security status (5.1% bodyweight lost vs 1.1% in food secure participants and 5.1% bodyweight lost vs 1.3% in food insecure participants at 6 months; 4.7% bodyweight lost vs 2.1% in food secure participants and 4.5% bodyweight lost vs 0.9% in food insecure participants at 12 months; p for interaction=0.99).
CONCLUSIONS
The REAL HEALTH-Diabetes lifestyle intervention led to meaningful weight loss for individuals with food insecurity and type 2 diabetes.
TRIAL REGISTRATION NUMBER
NCT02320253.",2020,Those with food insecurity were more likely to be racial/ethnic minorities (p<0.001) and have lower education (p<0.001).,"['individuals with diabetes vary by food insecurity status', 'Adults with type', '208 participants', 'individuals with food insecurity and type 2 diabetes']","['lifestyle intervention', 'LI (delivered inperson or by telephone) with medical nutrition therapy (MNT', 'lifestyle intervention (LI']","['weight loss', 'food security status']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1257928', 'cui_str': 'Medical Nutrition Therapy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",208.0,0.185464,Those with food insecurity were more likely to be racial/ethnic minorities (p<0.001) and have lower education (p<0.001).,"[{'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Berkowitz', 'Affiliation': 'Division of General Medicine & Clinical Epidemiology, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Porneala', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Cromer', 'Affiliation': 'Diabetes Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA Delahanty.linda@mgh.harvard.edu DWEXLER@mgh.harvard.edu.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Delahanty', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA Delahanty.linda@mgh.harvard.edu DWEXLER@mgh.harvard.edu.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001514']
2952,32979042,Quality of life outcomes from a randomized controlled trial of patient navigation in Latina breast cancer survivors.,"INTRODUCTION
Breast cancer survivorship is a life-long process involving challenges to health-care communities and individuals, especially Latinas. Patient Navigation has shown some success in meeting these challenges. The purpose of this study was to compare the effects of an enhanced Patient Navigation program (Intervention; PN+) vs Control (PN) over time on general cancer and breast cancer-specific quality of life (QoL) in Latina breast cancer survivors (BCS).
METHODS
We conducted a 2-year, two-arm randomized controlled trial of the ""Staying Healthy"" program among Latina BCS. The design compared PN+ vs PN over time. We recruited 60 patients into each study arm and randomized them by sequential numerical assignment. PN+ participants received culturally tailored educational materials and active, personalized Patient Navigation services, including phone calls, transportation, and care coordination. PN participants were navigated only upon request. Primary outcomes included general cancer (Functional Assessments of Cancer Therapy [FACTS]-G) and breast cancer-specific (FACT-B) QoL.
RESULTS
PN+ participants had significantly improved QoL measures compared to PN at 6-month follow-up on all subscales (P-values .007-.04) except physical well-being (PWB; P = .11). Intervention effect size coefficient (standard error) for FACT-G overall was 7.9 (3.1); P = .01. For FACT-B, it was 10.9 (3.9); P = .006. Again, all subscales showed significant effects [range 1.7-3.1 (0.8-1.2); P-values .006-.04], except for PWB [1.5 (1.0); P = .16] and social/family well-being (SWB) [2.1 (1.1); P = .06]. There were no differences between groups at baseline.
DISCUSSION
Multiple cultural, psychosocial, and socioeconomic variables contributing to these intervention effects will be addressed in future studies. As the national BCS population continues to increase, more Patient Navigation-focused partnerships among patients, health-care professionals, research groups, and community organizations are needed to improve BCS experiences. The Staying Healthy program has the potential to serve as a national survivorship care model for improving Latina BCS QoL.",2020,"QoL.
RESULTS
PN+ participants had significantly improved QoL measures compared to PN at 6-month follow-up on all subscales (P-values .007-.04) except physical well-being (PWB; P = .11).","['Latina breast cancer survivors (BCS', 'Latina breast cancer survivors', 'Latina BCS']","['Staying Healthy"" program', 'patient navigation', 'enhanced Patient Navigation program (Intervention; PN+) vs Control (PN', 'culturally tailored educational materials and active, personalized Patient Navigation services, including phone calls, transportation, and care coordination']","['Quality of life outcomes', 'general cancer and breast cancer-specific quality of life (QoL', 'QoL measures', 'general cancer (Functional Assessments of Cancer Therapy [FACTS]-G) and breast cancer-specific (FACT-B']","[{'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",60.0,0.0566853,"QoL.
RESULTS
PN+ participants had significantly improved QoL measures compared to PN at 6-month follow-up on all subscales (P-values .007-.04) except physical well-being (PWB; P = .11).","[{'ForeName': 'Amelie G', 'Initials': 'AG', 'LastName': 'Ramirez', 'Affiliation': 'Department of Population Health Sciences, UT Health San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Muñoz', 'Affiliation': 'Department of Population Health Sciences, UT Health San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Long Parma', 'Affiliation': 'Department of Population Health Sciences, UT Health San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Arely', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Department of Population Health Sciences, UT Health San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Santillan', 'Affiliation': 'Department of Population Health Sciences, UT Health San Antonio, San Antonio, TX, USA.'}]",Cancer medicine,['10.1002/cam4.3272']
2953,32979708,"The comparison of the effect of soybean and fish oil on supplementation on menopausal symptoms in postmenopausal women: A randomized, double-blind, placebo-controlled trial.","BACKGROUND
The effect of soybean and omega-3 fatty acid supplementation on menopausal symptoms in postmenopausal women was investigated.
MATERIALS AND METHODS
In a randomized, double-blind, placebo-controlled trial postmenopausal women were randomly given either soybean (Soygan 500 mg capsule; n = 60), or omega-3 fatty acids (Omega-rex 1000 mg soft gel; n = 60), or placebo (n = 60) daily for 12 weeks. The primary outcome was a change on the menopause rating scale score (MRS), while the secondary outcome was any adverse symptoms and effect was effect of soybean or omega-3 fatty acid supplements on the blood lipids and thyroid hormone.
RESULTS
Based on the results of post-hoc in terms of overall MRS score there was a significant difference between the control and Soygan (p < 0.001) and Omega-rex groups (p = 0.03); however, there was no significant difference between the two intervention groups (p = 0.86). Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
CONCLUSION
Soygan and Omega-rex reduced the MRS score and improved menopausal symptoms in postmenopausal women.",2020,"Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
","['controlled trial postmenopausal women', 'postmenopausal women']","['soybean and omega-3 fatty acid supplementation', 'Omega-rex 1000\xa0mg soft gel; n\xa0=\xa060), or placebo', 'soybean or omega-3 fatty acid supplements', 'placebo', 'soybean and fish oil on supplementation', 'soybean (Soygan 500\xa0mg capsule; n\xa0=\xa060), or omega-3 fatty acids ']","['MRS score and improved menopausal symptoms', 'blood lipids and thyroid hormone', 'overall MRS score', 'menopausal symptoms', 'menopause rating scale score (MRS']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0324505', 'cui_str': 'Rex cat breed'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.663549,"Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
","[{'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Purzand', 'Affiliation': 'School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Rokhgireh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran. Electronic address: s.rokhgireh@gmail.com.'}, {'ForeName': 'Mansoore', 'Initials': 'M', 'LastName': 'Shabani Zanjani', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Eshraghi', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Mahdiss', 'Initials': 'M', 'LastName': 'Mohamadianamiri', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Esmailzadeh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Alkatout', 'Affiliation': 'Department of Obstetrics and Gynecology, Kiel School of Gynaecological Endoscopy, University Hospital Schleswig Holstein, Campus Kiel, Arnold-Heller-Str. 3, Haus C, 24105, Kiel, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Gitas', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of Schleswig Holstein, Luebeck, Germany.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Allahqoli', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101239']
2954,32985369,Intravenous administration of tranexamic acid in total hip arthroplasty does not change the blood coagulopathy: a prospective thrombelastography analysis.,"OBJECTIVE
Despite the wide use of tranexamic acid (TXA) in the perioperative period of total hip arthroplasty (THA), whether the hemostatic state changes after the application of intravenous (IV)-TXA are still unknown. The aim of this study was to investigate whether IV administration of TXA changes the blood coagulation following primary THA via thrombelastography (TEG) analysis and conventional laboratory tests.
METHODS
A total of 174 patients who underwent primary THA from September 2016 to July 2018 were selected. They were randomly divided into two groups, 86 patients with IV administration of 15 mg/kg TXA and 88 controls without TXA usage. Demographic data, TEG paremeters, d-dimer levels, fibrin degradation products, hemoglobin, hematocrit concentration, platelet, transfusion rates, perioperative blood loss, and the occurrence of deep vein thrombosis were collected. TEG and conventional laboratory tests were performed the day before operation, the first day after operation, and seventh day after operation.
RESULTS
There were no differences with regard to TEG or conventional laboratory tests between the two groups ( p > 0.05). The total blood loss and drain blood loss in the TXA group were significantly lower than those in the control group ( p < 0.05). The transfusion rates and the volume of blood transfusion of the control group were higher than those of the TXA group ( p < 0.05).
CONCLUSION
The administration of IV-TXA resulted in a significant reduction in total blood loss, transfusion volumes, and transfusion rates without the increase of thromboembolic complications. Moreover, it was confirmed that TXA would not change the coagulation via the TEG analysis.",2020,There were no differences with regard to TEG or conventional laboratory tests between the two groups ( p > 0.05).,"['174 patients who underwent primary THA from September 2016 to July 2018 were selected', '86 patients with', 'total hip arthroplasty (THA']","['IV-TXA', 'tranexamic acid (TXA', 'tranexamic acid', 'IV administration of 15 mg/kg TXA', 'TXA']","['total blood loss, transfusion volumes, and transfusion rates', 'thromboembolic complications', 'total blood loss and drain blood loss', 'transfusion rates and the volume of blood transfusion', 'TEG or conventional laboratory tests', 'Demographic data, TEG paremeters, d-dimer levels, fibrin degradation products, hemoglobin, hematocrit concentration, platelet, transfusion rates, perioperative blood loss, and the occurrence of deep vein thrombosis', 'blood coagulopathy']","[{'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0163275', 'cui_str': 'Fibrin degradation product'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}]",86.0,0.0203299,There were no differences with regard to TEG or conventional laboratory tests between the two groups ( p > 0.05).,"[{'ForeName': 'Xing-Chen', 'Initials': 'XC', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Ma-Ji', 'Initials': 'MJ', 'LastName': 'Sun', 'Affiliation': 'Department of Orthopaedics, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Department of Orthopaedics, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Rui', 'Affiliation': ""Department of Orthopaedics, Jiangsu Jiangyin People's Hospital, Jiangyin, China.""}, {'ForeName': 'Feng-Chao', 'Initials': 'FC', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopaedics, 71069The First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Guo-Chun', 'Initials': 'GC', 'LastName': 'Zha', 'Affiliation': 'Department of Orthopaedics, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': 'Department of Orthopaedics, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Orthopaedics, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Kai-Jin', 'Initials': 'KJ', 'LastName': 'Guo', 'Affiliation': 'Department of Orthopaedics, 117910The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499020959516']
2955,32980608,Interprofessional simulation-based training in gynecologic oncology palliative care for students in the healthcare profession: A comparative randomized controlled trial.,"BACKGROUND
Preprofessional palliative care education may be inadequate, leaving a gap in health professional students' knowledge and understanding of managing patients with gynecologic cancer and their families. Interprofessional simulation-based training may be useful in helping health professional students gain the necessary skills required for palliative care.
OBJECTIVE
This study aimed to determine the effectiveness of different simulation methods used for interprofessional training on gynecologic oncology palliative care knowledge, interdisciplinary education perceptions, and teamwork attitudes of health professional students and to compare these methods.
DESIGN
A comparative randomized controlled trial was conducted with a pre-test and two post-tests.
SETTINGS
This study was conducted at a university in Ankara, Turkey, in 2016-2017.
PARTICIPANTS
A convenience sample of 84 interprofessional students (nursing, medical, nutrition-dietician, and social work) was used in the study.
METHODS
Students were stratified by their profession and randomized by four blocks into high-fidelity simulation, hybrid simulation, and a control group. Data were collected using a semi-structured questionnaire form, palliative care knowledge test, interdisciplinary education perception scale, and teamwork attitudes questionnaire.
RESULTS
The high-fidelity simulation and hybrid simulation groups improved their palliative care knowledge, interdisciplinary education perception, and teamwork attitudes from pre-test to first and second post-tests compared to the control group.
CONCLUSION
The introduction of high-fidelity simulation and hybrid simulation or hybrid simulation-based interprofessional training in undergraduate education can increase students' palliative care knowledge, interdisciplinary education perception, and teamwork attitudes. Training programs that are used together with high-fidelity simulation and hybrid simulation applications in interdisciplinary training should be integrated into the undergraduate curricula of future cooperating health professions.",2020,"The high-fidelity simulation and hybrid simulation groups improved their palliative care knowledge, interdisciplinary education perception, and teamwork attitudes from pre-test to first and second post-tests compared to the control group.
","['health professional students', 'A convenience sample of 84 interprofessional students (nursing, medical, nutrition-dietician, and social work) was used in the study', 'patients with gynecologic cancer and their families', 'Students were stratified by their profession', 'students in the healthcare profession', 'university in Ankara, Turkey, in 2016-2017']","['interprofessional training', 'Interprofessional simulation-based training', 'hybrid simulation-based interprofessional training']","['palliative care knowledge, interdisciplinary education perception, and teamwork attitudes']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",84.0,0.0506668,"The high-fidelity simulation and hybrid simulation groups improved their palliative care knowledge, interdisciplinary education perception, and teamwork attitudes from pre-test to first and second post-tests compared to the control group.
","[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Uslu-Sahan', 'Affiliation': 'Department of Obstetrics and Gynecologic Nursing, Faculty of Nursing, Hacettepe University, Ankara, Turkey. Electronic address: fatma.uslu@hacettepe.edu.tr.'}, {'ForeName': 'Fusun', 'Initials': 'F', 'LastName': 'Terzioglu', 'Affiliation': 'Faculty of Health Science, Atilim University, Ankara, Turkey.'}]",Nurse education today,['10.1016/j.nedt.2020.104588']
2956,32980656,Effectiveness of the Super Skills for Life programme in enhancing the emotional wellbeing of children and adolescents in residential care institutions in a low- and middle-income country: A randomised waitlist-controlled trial.,"BACKGROUND
The present study examined the effectiveness of a transdiagnostic prevention programme, Super Skills for Life (SSL), among children and adolescents with emotional problems in residential care institutions (RCIs) in the low- and middle-income country of Mauritius using a randomised waitlist-controlled trial (RCT). SSL is based on the principles of cognitive behavioural therapy, behavioural activation, social skills training, and uses video-feedback and cognitive preparation as part of the treatment.
METHODS
The RCT involved 100 children and adolescents aged 9 to 14 years, from six RCIs, randomly allocated to either an SSL intervention group (IG) or a waitlist-control (WLC) group. A set of questionnaires measuring internalising and externalising problems, emotion regulation and self-esteem, and experimental tasks measuring attentional bias and inhibitory control, were completed at baseline, post-intervention and 3-month follow-up. Participants also completed a 2-min video speech task during the first and final sessions of the SSL intervention.
RESULTS
Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up. These findings were not replicated among children in the WLC.
LIMITATIONS
The small sample size and lack of an active control group were the major limitations of this study.
CONCLUSIONS
This study provides evidence for the effectiveness of a transdiagnostic prevention programme for emotional problems in RCIs in a low- and middle-income country.",2020,"RESULTS
Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up.","['children and adolescents with emotional problems in residential care institutions (RCIs) in the low- and middle-income country of Mauritius', 'children and adolescents in residential care institutions in a low- and middle-income country', 'emotional problems in RCIs in a low- and middle-income country', '100 children and adolescents aged 9 to 14 years, from six RCIs']","['transdiagnostic prevention programme', 'SSL intervention group (IG) or a waitlist-control (WLC', 'Super Skills for Life programme', 'transdiagnostic prevention programme, Super Skills for Life (SSL', 'SSL']","['emotional wellbeing', 'maladaptive emotion regulation strategies', 'internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control', 'questionnaires measuring internalising and externalising problems, emotion regulation and self-esteem, and experimental tasks measuring attentional bias and inhibitory control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0024944', 'cui_str': 'Mauritius'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}]",100.0,0.0681738,"RESULTS
Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up.","[{'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Ramdhonee-Dowlot', 'Affiliation': 'Department of Psychology, University of Roehampton, UK. Electronic address: ramdhonk@roehampton.ac.uk.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Balloo', 'Affiliation': 'University of Surrey, UK.'}, {'ForeName': 'Cecilia A', 'Initials': 'CA', 'LastName': 'Essau', 'Affiliation': 'Department of Psychology, University of Roehampton, UK.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.053']
2957,32990454,Dextrose Prolotherapy Versus Normal Saline Injection for the Treatment of Lateral Epicondylopathy: A Randomized Controlled Trial.,"Objective: To compare the effect of dextrose prolotherapy (DPT) with saline in the treatment of chronic lateral epicondylopathy (LE). Design: Triple-blinded randomized controlled trial. Setting: Physical medicine and rehabilitation outpatient clinic. Subjects: Sixty cases of chronic LE participants were included in the study. Methods: Participants were randomly divided into two groups as DPT and normal saline. Saline or hypertonic dextrose (15%) was injected at the baseline, and at the end of the 4th and 8th week. Assessments were performed at baseline, and at the end of the 4th, 8th, and 12th week. Outcome measures: Primary outcome measures were Visual Analog Scale (VAS) for pain, Patient Rated Tennis Elbow Evaluation (PRTEE-Total [PRTEE-T], PRTEE-Pain, PRTEE-Function); secondary outcome measures were Disabilities of the Arm, Shoulder, and Hand Score (DASH) and pain-free handgrip strength. Results: Intragroup analysis demonstrated that both groups significantly improved in VAS, PRTEE, DASH scores, and handgrip strength during the study period ( p < 0.001, for all outcome measurements in both groups). Intergroup analysis showed that PRTEE-T score changes between baseline-4th and -12th week; VASrest change between baseline and 4th week in the DPT group were significantly higher than the saline group ( p = 0.041, p = 0.038, p = 0.013 respectively). There was no significant difference between groups in VAS, DASH scores, and handgrip strength between any time points, in terms of improvement ( p > 0.05). Conclusion: Our study results showed that DPT outperformed saline in PRTEE-T score. Although saline seems to be a comparable clinical effect with DPT, further studies comparing the effects of saline injection and DPT are necessary, in chronic LE.",2020,"Intragroup analysis demonstrated that both groups significantly improved in VAS, PRTEE, DASH scores, and handgrip strength during the study period ( p < 0.001, for all outcome measurements in both groups).","['Sixty cases of chronic LE participants were included in the study', 'chronic lateral epicondylopathy (LE', 'Lateral Epicondylopathy', 'Subjects']","['DPT and normal saline', 'dextrose prolotherapy (DPT) with saline', 'Saline or hypertonic dextrose', 'DPT', 'saline injection and DPT', 'Dextrose Prolotherapy Versus Normal Saline Injection']","['VAS, PRTEE, DASH scores, and handgrip strength', 'Visual Analog Scale (VAS) for pain, Patient Rated Tennis Elbow Evaluation (PRTEE-Total [PRTEE-T], PRTEE-Pain, PRTEE-Function', 'Disabilities of the Arm, Shoulder, and Hand Score (DASH) and pain-free handgrip strength', 'VAS, DASH scores, and handgrip strength']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}]","[{'cui': 'C0636923', 'cui_str': 'diphenylthiosulfinate'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0500223', 'cui_str': 'Prolotherapy'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}]",,0.227854,"Intragroup analysis demonstrated that both groups significantly improved in VAS, PRTEE, DASH scores, and handgrip strength during the study period ( p < 0.001, for all outcome measurements in both groups).","[{'ForeName': 'Seniz', 'Initials': 'S', 'LastName': 'Akcay', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Izmir Bozyaka Education and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Nese', 'Initials': 'N', 'LastName': 'Gurel Kandemir', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Izmir Bozyaka Education and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Taciser', 'Initials': 'T', 'LastName': 'Kaya', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Izmir Bozyaka Education and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Nesibe', 'Initials': 'N', 'LastName': 'Dogan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Izmir Bozyaka Education and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Eren', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Eskisehir Yunus Emre State Hospital, Eskisehir, Turkey.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0286']
2958,32987227,Family Integrated Care (FICare): Positive impact on behavioural outcomes at 18 months.,"BACKGROUND
Children born very preterm demonstrate behavioural challenges due to clinical factors, exposure to the high stress environment of intensive care, and separation from parents during neonatal hospitalization at a critical stage in development. Family Integrated Care (FICare) significantly reduced parent stress and anxiety, and improved neonatal outcomes.
AIMS
To examine the impact of FICare on behavioural outcomes at 18-21 months corrected age (CA), and assess possible mediation through parenting or infant growth.
STUDY DESIGN AND METHODS
A prospective cohort study enrolling infants under 33 weeks gestation and parents from the FICare cluster randomized controlled trial. Primary outcome was behaviour assessed by the Infant Toddler Social Emotional Assessment (ITSEA). Parent child variables were measured with the Nursing Child Assessment Satellite Training (NCAST), Parenting Stress Index (PSI) and infant growth.
RESULTS
Subjects included 123 FICare infants and 62 standard care controls evaluated at 18-21 months CA. FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01). At 12 months CA, the NCAST Child subtotal score was higher and the PSI-Child Domain score was lower in FICare infants than non-FICare infants. The PSI-Child domain was identified as a possible mediator of FICare on child behaviour (mediation effect 1.28, -2.96-0.02, p = 0.044).
CONCLUSION
FICare in the NICU has a sustained effect on child behaviour, improving self-regulation at 18-21 months CA.",2020,"FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01).","['A prospective cohort study enrolling infants under 33\xa0weeks gestation and parents from the FICare cluster randomized controlled trial', 'Children born very preterm', 'Subjects included 123 FICare infants and 62 standard care controls evaluated at 18-21\xa0months CA']","['FICare', 'Family Integrated Care (FICare']","['parent stress and anxiety, and improved neonatal outcomes', 'Nursing Child Assessment Satellite Training (NCAST), Parenting Stress Index (PSI) and infant growth', 'behavioural outcomes', 'PSI-Child Domain score', 'lower ITSEA Dysregulation', 'NCAST Child subtotal score', 'behaviour assessed by the Infant Toddler Social Emotional Assessment (ITSEA', 'self-regulation skills', 'child behaviour, improving self-regulation']","[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021272', 'cui_str': 'Infant care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036238', 'cui_str': 'Associated Viruses'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",123.0,0.0623273,"FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01).","[{'ForeName': 'Paige Terrien', 'Initials': 'PT', 'LastName': 'Church', 'Affiliation': ""Sunnybrook Health Sciences Centre, Department of Newborn and Developmental Paediatrics, 2075 Bayview Avenue, M4-234, Toronto, ON M4N 3M5, Canada; University of Toronto, Department of Paediatrics, 27 King's College Cir, Toronto, ON M5S 3H7, Canada.""}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Grunau', 'Affiliation': ""University of British Columbia, Department of Pediatrics and BC Children's Research Institute, 4500 Oak Street, Vancouver, BC V6H 3N1, Canada; BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mirea', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Petrie', 'Affiliation': ""BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Amuchou Singh', 'Initials': 'AS', 'LastName': 'Soraisham', 'Affiliation': ""Alberta Children's Hospital Research Institute, Foothills Medical Centre, University of Calgary, 1403, 29th Street NW, Calgary, AB T2N 2T9, Canada.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Synnes', 'Affiliation': ""University of British Columbia, Department of Pediatrics and BC Children's Research Institute, 4500 Oak Street, Vancouver, BC V6H 3N1, Canada; BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Xiang Y', 'Initials': 'XY', 'LastName': 'Ye', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': ""O'Brien"", 'Affiliation': ""University of Toronto, Department of Paediatrics, 27 King's College Cir, Toronto, ON M5S 3H7, Canada; Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada; Mount Sinai Hospital, Department of Paediatrics, 600 University Avenue, Toronto, ON M5G 1X5, Canada. Electronic address: karel.obrien@sinaihealth.ca.""}]",Early human development,['10.1016/j.earlhumdev.2020.105196']
2959,32987282,Fundamental frequency during cognitive preparation and its impact on therapy outcome for panic disorder with Agoraphobia.,"BACKGROUND
Cognitive preparation plays a crucial role in CBT with exposure for panic disorder and agoraphobia. High emotional arousal while developing the exposure rationale might impair patients' cognitive capacities for processing information about treatment and impede therapeutic outcome.
OBJECTIVE
This study investigates whether patients' vocally encoded emotional arousal, assessed by fundamental frequency (f 0 ), during rationale development is associated with premature treatment dropout, insight into the rationale, and symptom reduction.
METHODS
Patients' (N = 197, mean age 36.1 years, 79.2% female) f 0 during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia. Insight was rater assessed. Symptom severity was self- and rater assessed at the beginning and end of therapy.
RESULTS
Higher f 0 mean during rationale development was associated with lower probability of insight and less reduction in avoidance behavior. f 0 was not associated with dropout. Insight was associated with lower probability of dropout and partially mediated the association between f 0 and avoidance reduction.
DISCUSSION
This study highlights the importance of emotional arousal during cognitive preparation for exposure. Therapists should ensure that patients are not too highly aroused while learning about the exposure rationale as an important step in treatment.",2020,f 0 during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia.,"['panic disorder with Agoraphobia', ""Patients' (N\xa0=\xa0197, mean age 36.1 years, 79.2% female""]",['CBT'],['avoidance behavior'],"[{'cui': 'C0236800', 'cui_str': 'Panic disorder with agoraphobia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}]",,0.0479158,f 0 during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia.,"[{'ForeName': 'Gesine', 'Initials': 'G', 'LastName': 'Wieder', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany; Department of Differential and Personality Psychology, Dresden University of Technology, Zellescher Weg 17, 01069, Dresden, Germany. Electronic address: gesine.wieder@tu-dresden.de.'}, {'ForeName': 'Melanie S', 'Initials': 'MS', 'LastName': 'Fischer', 'Affiliation': 'Institute of Medical Psychology, Heidelberg University Hospital, Bergheimer Strasse 20, 69115, Heidelberg, Germany; Faculty of Behavioural and Cultural Studies, Ruprecht-Karls University Heidelberg, Voßstrasse 2, 69115, Heidelberg, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Einsle', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany.'}, {'ForeName': 'Donald H', 'Initials': 'DH', 'LastName': 'Baucom', 'Affiliation': 'Department of Psychology and Neuroscience, Davie Hall, CB #3270, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599-3270, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Hahlweg', 'Affiliation': 'Institute for Psychology, Department of Clinical Psychology, Psychotherapy and Diagnostics, Technische Universitaet Braunschweig, Mail address: Schwäbische Str. 7, 10781, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet, Nussbaumstraße 7, 80336, Munich, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Weusthoff', 'Affiliation': 'Institute for Psychology, Department of Clinical Psychology, Psychotherapy and Diagnostics, Technische Universitaet Braunschweig, Mail address: Schwäbische Str. 7, 10781, Berlin, Germany; Private Psychotherapeutic Practice, Everswinkeler Strasse 4, 48351, Alverskirchen, Germany.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103728']
2960,32987332,Lamotrigine for reducing ketamine-induced psychologic disturbances: A pilot randomized and blinded trial.,,2020,,['induced psychologic disturbances'],"['ketamine', 'Lamotrigine']",[],"[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}]",[],,0.14572,,"[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America. Electronic address: MAHESHK@ccf.org.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Bakal', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Xuan', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Wael Ali Sakr', 'Initials': 'WAS', 'LastName': 'Esa', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Department of Psychiatry, Cleveland Clinic, Cleveland, OH, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110074']
2961,32991818,Effects of fecal microbiota transplantation in subjects with irritable bowel syndrome are mirrored by changes in gut microbiome.,"Irritable bowel syndrome (IBS) is a common disorder of the lower gastrointestinal tract. The pathophysiology is far from settled, but a gut microbial dysbiosis is hypothesized to be a contributing factor. We earlier published a randomized double-blind placebo-controlled clinical trial on fecal microbiota transplantation (FMT) for IBS - the REFIT trial. The present data set describes the engraftment and includes participants from the study who received active FMT; 14 participants with effect of FMT ( Effect ) and 8 without ( No effect ). Samples were collected at baseline, after 6 and 12 months. Samples from the transplants ( Donor ) served as a comparator. In total 66 recipient samples and 17 donor samples were subjected to deep metagenomic sequencing, and taxonomic and functional analyses were performed. Alpha diversity measures showed a significantly increased diversity and evenness in the IBS groups compared to the donors. Taxonomic profiles showed higher relative abundance of phylum Firmicutes, and lower relative abundance of phylum Bacteroidetes, compared to donors at baseline. This profile was shifted toward the donor profile following FMT. Imputed growth rates showed that the resulting growth pattern was a conglomerate of donor and recipient activity. Thirty-four functional subclasses showed distinct differences between baseline samples and donors, most of which were shifted toward a donor-like profile after FMT. All of these changes were less pronounced in the No effect group. We conclude that FMT induces long-term changes in gut microbiota, and these changes mirror the clinical effect of the treatment. The study was registered in ClinicalTrials.gov (NCT02154867).",2020,"Taxonomic profiles showed higher relative abundance of phylum Firmicutes, and lower relative abundance of phylum Bacteroidetes, compared to donors at baseline.",['subjects with irritable bowel syndrome'],"['FMT', 'placebo', 'active FMT', 'fecal microbiota transplantation']","['Irritable bowel syndrome (IBS', 'diversity and evenness']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]",14.0,0.0750479,"Taxonomic profiles showed higher relative abundance of phylum Firmicutes, and lower relative abundance of phylum Bacteroidetes, compared to donors at baseline.","[{'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Goll', 'Affiliation': 'Research Group of Gastroenterology and Nutrition, Department of Clinical Medicine, UiT the Arctic University of Norway , Tromsø, Norway.'}, {'ForeName': 'Peter Holger', 'Initials': 'PH', 'LastName': 'Johnsen', 'Affiliation': 'Research Group of Gastroenterology and Nutrition, Department of Clinical Medicine, UiT the Arctic University of Norway , Tromsø, Norway.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hjerde', 'Affiliation': 'Institute of Chemistry, UiT the Arctic University of Norway , Tromsø, Norway.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Diab', 'Affiliation': 'Natural Products and Medicinal Chemistry Research Group, Department of Pharmacy, UiT the Arctic University of Norway , Tromsø, Norway.'}, {'ForeName': 'Per Christian', 'Initials': 'PC', 'LastName': 'Valle', 'Affiliation': 'Department of Internal Medicine, University Hospital of North Norway , Harstad, Norway.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hilpusch', 'Affiliation': 'Sjøkanten Legesenter , Harstad, Norway.'}, {'ForeName': 'Jorunn Pauline', 'Initials': 'JP', 'LastName': 'Cavanagh', 'Affiliation': 'Pediatric Infections Group. Department of Pediatrics, University Hospital of North Norway , Tromsø, Norway.'}]",Gut microbes,['10.1080/19490976.2020.1794263']
2962,32992785,The Effects of 6-Month Vitamin D Supplementation during the Non-Surgical Treatment of Periodontitis in Vitamin-D-Deficient Patients: A Randomized Double-Blind Placebo-Controlled Study.,"BACKGROUND
This study assessed the effects of weekly vitamin D (VD) supplementation on clinical and biological parameters after scaling and root planning (SRP) in the treatment of periodontitis and served to validate the VD dosage regimen.
METHODS
It was a monocentric, randomized, double-blind, placebo-controlled clinical trial with 6 months follow-up. Healthy Caucasian periodontitis patients presenting serum 25(OH) vitamin D3 below 30 ng/mL were randomly allocated to test group (SRP + VD 25,000 international units (IU)/week) or the control group (SRP + placebo).
RESULTS
A total of 59 patients were screened, 27 were included and 26 completed 3 months (M) and 21 completed 6M control. Test ( n = 13) and control groups ( n = 14) had similar 25(OH) vitamin D3 levels at baseline (17.6 ± 7.4 vs. 14.4 ± 5.2, respectively). After one month, there was a significant difference between groups (32.9 ± 5.2 vs. 16.1 ± 4.7), also seen at M3 and M6 ( t -test, p < 0.001). Periodontal treatment was successful in both groups, since it resulted in a reduction of all measured clinical parameters at M3 and M6 (probing pocket depth (PPD), full mouth bleeding and plaque). However, the reduction in PPD was greater in the test group.
CONCLUSIONS
In this short-term pilot study, no significant differences were observed between two groups. However, supplementation with VD tended to improve the treatment of periodontitis in patients with initial 25(OH) vitamin D3 < 30 ng/mL and proved safe and efficacious. NCT03162406.",2020,"Periodontal treatment was successful in both groups, since it resulted in a reduction of all measured clinical parameters at M3 and M6 (probing pocket depth (PPD), full mouth bleeding and plaque).","['Healthy Caucasian periodontitis patients presenting serum 25(OH) vitamin D3 below 30 ng/mL', 'Periodontitis in Vitamin-D-Deficient Patients', 'patients with initial 25(OH) vitamin D3', 'A total of 59 patients were screened, 27 were included and 26 completed 3 months (M) and 21 completed 6M control']","['scaling and root planning (SRP', 'test group (SRP + VD 25,000 international units (IU)/week) or the control group (SRP + placebo', '6-Month Vitamin D Supplementation', 'placebo', 'vitamin D (VD) supplementation', 'Placebo']","['PPD', 'clinical parameters at M3 and M6 (probing pocket depth (PPD), full mouth bleeding and plaque', 'similar 25(OH) vitamin D3 levels', 'safe and efficacious']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439453', 'cui_str': 'IU'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0029163', 'cui_str': 'Bleeding from mouth'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",59.0,0.273972,"Periodontal treatment was successful in both groups, since it resulted in a reduction of all measured clinical parameters at M3 and M6 (probing pocket depth (PPD), full mouth bleeding and plaque).","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Perić', 'Affiliation': 'Department of Surgery, Medical, Molecular, and Critical Area, University of Pisa, 56126 Pisa, Italy.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Maiter', 'Affiliation': 'Department of Endocrinology and Nutrition, Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Cavalier', 'Affiliation': 'Department of Clinical Chemistry, CHU Sart-Tilman, University of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Jérôme F', 'Initials': 'JF', 'LastName': 'Lasserre', 'Affiliation': 'Service de Parodontologie, Ecole de Médecine Dentaire-Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium.'}, {'ForeName': 'Selena', 'Initials': 'S', 'LastName': 'Toma', 'Affiliation': 'Service de Parodontologie, Ecole de Médecine Dentaire-Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium.'}]",Nutrients,['10.3390/nu12102940']
2963,32992801,Conjunctival Injection Reduction in Patients with Atopic Keratoconjunctivitis Due to Synergic Effect of Bovine Enteric-Coated Lactoferrin in 0.1% Tacrolimus Ophthalmic Suspension.,"Lactoferrin (LF), a multifunctional glycoprotein found in mammalian milk, is reported to have immunoregulatory effects. The present study aimed to evaluate whether enteric-coated LF (eLF) could improve symptoms in patients with atopic keratoconjunctivitis (AKC). This randomized double-blind placebo-controlled single-center trial comprised Japanese patients (n = 20; aged 22-60 years) with AKC. Patients treated with 0.1% tacrolimus ophthalmic suspension (TALYMUS ® ) were administered eLF (400 mg/d of bovine LF) or placebo tablets for 12 weeks. Conjunctival injection was examined, papillae formation in the palpebral conjunctiva was evaluated, and corneal fluorescein score, itchy sensation in end-point itching scale, and serum allergic parameters were assessed. Conjunctival injection was significantly reduced in the LF group than in the placebo group ( p = 0.0017, Mann-Whitney U-test). Papillae formation in the palpebral conjunctiva showed a statistical decrease in the LF group than in the placebo group ( p = 0.010, unpaired T-test). LF combined with TALYMUS ® could be a promising treatment strategy to mitigate AKC.",2020,"Papillae formation in the palpebral conjunctiva showed a statistical decrease in the LF group than in the placebo group ( p = 0.010, unpaired T-test).","['Patients with Atopic Keratoconjunctivitis', 'Japanese patients (n = 20; aged 22-60 years) with AKC', 'patients with atopic keratoconjunctivitis (AKC']","['eLF', 'Bovine Enteric-Coated Lactoferrin', 'Tacrolimus Ophthalmic Suspension', 'tacrolimus ophthalmic suspension (TALYMUS ® ', 'Lactoferrin (LF', 'LF combined with TALYMUS ®', 'placebo', 'enteric-coated LF (eLF']","['Conjunctival injection', 'Conjunctival Injection Reduction', 'corneal fluorescein score, itchy sensation in end-point itching scale, and serum allergic parameters', 'Papillae formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274788', 'cui_str': 'Atopic keratoconjunctivitis'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0991532', 'cui_str': 'Eye suspension'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",20.0,0.44871,"Papillae formation in the palpebral conjunctiva showed a statistical decrease in the LF group than in the placebo group ( p = 0.010, unpaired T-test).","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Fujishima', 'Affiliation': 'Department of Ophthalmology, Tsurumi University School of Dental Medicine, Tsurumi, Yokohama 230-8501, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Okada', 'Affiliation': 'Department of Ophthalmology, Tsurumi University School of Dental Medicine, Tsurumi, Yokohama 230-8501, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Allergy and Clinical Immunology, National Research Institute for Child Health and Development, Tokyo 157-8535, Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Shimizu', 'Affiliation': 'Department of Ophthalmology, Keio University School of Medicine, Tokyo 160-8582, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Fukuda', 'Affiliation': 'Institute for Advanced Biosciences, Keio University, Tsuruoka, Yamagata 997-0052, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Tomita', 'Affiliation': 'Institute for Advanced Biosciences, Keio University, Tsuruoka, Yamagata 997-0052, Japan.'}]",Journal of clinical medicine,['10.3390/jcm9103093']
2964,32992830,Effects of a Multi-Ingredient Preworkout Supplement Versus Caffeine on Energy Expenditure and Feelings of Fatigue during Low-Intensity Treadmill Exercise in College-Aged Males.,"The primary purpose of this study was to examine the acute effects of a multi-ingredient (i.e., caffeine, green tea extract, Yohimbe extract, capsicum annum, coleus extract, L-carnitine, beta-alanine, tyrosine) preworkout supplement versus a dose of caffeine (6 mg·kg -1 ) on energy expenditure during low-intensity exercise. The effects of these treatments on substrate utilization, gas exchange, and psychological factors were also investigated. Twelve males (mean ± SD: age = 22.8 ± 2.4 years) completed three bouts of 60 min of treadmill exercise on separate days after consuming a preworkout supplement, 6 mg·kg -1 of caffeine, or placebo in a randomized fashion. The preworkout and caffeine supplements resulted in significantly greater energy expenditure ( p < 0.001, p = 0.006, respectively), V˙O 2 ( p < 0.001, p = 0.007, respectively), V˙CO 2 ( p = 0.006, p = 0.049, respectively), and V˙ E ( p < 0.001, p = 0.007, respectively) compared to placebo (collapsed across condition). There were no differences among conditions, however, for rates of fat or carbohydrate oxidation or respiratory exchange ratio. In addition, the preworkout supplement increased feelings of alertness ( p = 0.015) and focus ( p = 0.005) 30-min postingestion and decreased feelings of fatigue ( p = 0.014) during exercise compared to placebo. Thus, the preworkout supplement increased energy expenditure and measures of gas exchange to the same extent as 6 mg·kg -1 of caffeine with concomitant increased feelings of alertness and focus and decreased feelings of fatigue.",2020,"In addition, the preworkout supplement increased feelings of alertness ( p = 0.015) and focus ( p = 0.005) 30-min postingestion and decreased feelings of fatigue ( p = 0.014) during exercise compared to placebo.","['Twelve males (mean ± SD: age = 22.8 ± 2.4 years', 'College-Aged Males']","['placebo', 'multi-ingredient (i.e., caffeine, green tea extract, Yohimbe extract, capsicum annum, coleus extract, L-carnitine, beta-alanine, tyrosine) preworkout supplement versus a dose of caffeine', 'Multi-Ingredient Preworkout Supplement Versus Caffeine', 'treadmill exercise on separate days after consuming a preworkout supplement, 6 mg·kg -1 of caffeine, or placebo']","['feelings of alertness', 'energy expenditure and measures of gas exchange', 'feelings of fatigue', 'substrate utilization, gas exchange, and psychological factors', 'Energy Expenditure and Feelings of Fatigue', 'rates of fat or carbohydrate oxidation or respiratory exchange ratio', 'energy expenditure', 'feelings of alertness and focus and decreased feelings of fatigue']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557806', 'cui_str': 'College'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0006932', 'cui_str': 'Capsicum'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0873094', 'cui_str': 'Coleus'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0000392', 'cui_str': 'beta-Alanine'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",12.0,0.128225,"In addition, the preworkout supplement increased feelings of alertness ( p = 0.015) and focus ( p = 0.005) 30-min postingestion and decreased feelings of fatigue ( p = 0.014) during exercise compared to placebo.","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lutsch', 'Affiliation': 'Department of Kinesiology and Physical Education, Northern Illinois University, DeKalb, IL 60115, USA.'}, {'ForeName': 'Clayton L', 'Initials': 'CL', 'LastName': 'Camic', 'Affiliation': 'Department of Kinesiology and Physical Education, Northern Illinois University, DeKalb, IL 60115, USA.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Jagim', 'Affiliation': 'Sports Medicine, Mayo Clinic Health System, Onalaska, WI 54650, USA.'}, {'ForeName': 'Riley R', 'Initials': 'RR', 'LastName': 'Stefan', 'Affiliation': 'Department of Kinesiology and Physical Education, Northern Illinois University, DeKalb, IL 60115, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Cox', 'Affiliation': 'Department of Kinesiology and Physical Education, Northern Illinois University, DeKalb, IL 60115, USA.'}, {'ForeName': 'Rachel N', 'Initials': 'RN', 'LastName': 'Tauber', 'Affiliation': 'Department of Kinesiology and Physical Education, Northern Illinois University, DeKalb, IL 60115, USA.'}, {'ForeName': 'Shaine E', 'Initials': 'SE', 'LastName': 'Henert', 'Affiliation': 'Department of Kinesiology and Physical Education, Northern Illinois University, DeKalb, IL 60115, USA.'}]","Sports (Basel, Switzerland)",['10.3390/sports8100132']
2965,33000490,Neoadjuvant Pyrotinib plus Trastuzumab and Chemotherapy for Stage I-III HER2-Positive Breast Cancer: A Phase II Clinical Trial.,"LESSONS LEARNED
This is the first trial to explore the neoadjuvant therapy of pyrotinib in HER2-positive operable and locally advanced breast cancer, in combination with epirubicin plus cyclophosphamide followed by docetaxel plus trastuzumab. Results primarily showed that pyrotinib in combination with epirubicin plus cyclophosphamide followed by docetaxel plus trastuzumab was effective and safe in HER2-positive operable and locally advanced breast cancer. A subsequent randomized controlled trial is still warranted to confirm these results.
BACKGROUND
The efficacy and safety of neoadjuvant therapy of pyrotinib, a new irreversible tyrosine kinase inhibitor (TKI), was first estimated in patients with HER2-positive breast cancer in this phase II study, in combination with trastuzumab and chemotherapy.
METHODS
Between February 19, 2019, and November 20, 2019, 20 female Chinese patients with stage I-III HER2-positive breast cancer were assigned to receive eight cycles of neoadjuvant pyrotinib (P) in combination with four cycles of epirubicin (E) and cyclophosphamide (C) followed by four cycles of docetaxel (T) and trastuzumab (H), once every 3 weeks, referred to as P + EC-TH.
RESULTS
A total of 19 patients completed the therapy and final surgery. The total pathological complete response (tpCR) rate was 73.7% (95% confidence interval [CI], 48.8-90.9), and no recurrence or metastasis occurred during the short-term follow-up period. The objective response rate (ORR) was 100% (95% CI, 82.4-100). The most common adverse events (AEs) were diarrhea and leukopenia in 18 of 20 patients (90%), but no grade 5 AEs were reported.
CONCLUSION
This study showed that in HER2-positive operable or locally advanced breast cancer, the tpCR rate of P + EC-TH neoadjuvant therapy was about twice as high as that of EC-TH neoadjuvant therapy reported in other trials, with tolerable side effects.",2020,The objective response rate (ORR) was 100% (95% CI: 82.4-100).,"['19 patients completed the therapy and final surgery', 'patients with HER2-positive breast cancer', 'HER2-Positive Breast Cancer', 'HER2-positive operable and locally advanced breast cancer', 'Stage I-III', 'Between February 19, 2019, and November 20, 2019, 20 female Chinese patients with stage I-III HER2-positive breast cancer']","['epirubicin plus cyclophosphamide', 'neoadjuvant pyrotinib (P) in combination with four cycles of epirubicin (E), cyclophosphamide (C) followed by four cycles of docetaxel (T), trastuzumab (H), once every 3\u2009weeks, referred to as P + EC-TH', 'trastuzumab and chemotherapy', 'docetaxel plus trastuzumab', 'Neoadjuvant Pyrotinib plus Trastuzumab and Chemotherapy']","['diarrhea and leukopenia', 'recurrence or metastasis', 'objective response rate (ORR', 'tpCR rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3828434', 'cui_str': 'pyrotinib'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",19.0,0.0654802,The objective response rate (ORR) was 100% (95% CI: 82.4-100).,"[{'ForeName': 'Juncheng', 'Initials': 'J', 'LastName': 'Xuhong', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Tang', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Linjun', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Xuanni', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'He', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Minghao', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ""Department of Breast and Thyroid Surgery, Southwest Hospital, Army Medical University, Chongqing, People's Republic of China.""}]",The oncologist,['10.1002/onco.13546']
2966,32984784,"An open-label, randomized trial of the combination of IFN-κ plus TFF2 with standard care in the treatment of patients with moderate COVID-19.","Background
Epidemic outbreaks caused by SARS-CoV-2 are worsening around the world, and there are no target drugs to treat COVID-19. IFN-κ inhibits the replication of SARS-CoV-2; and TFF2 is a small secreted polypeptide that promotes the repair of mucosal injury and reduces the inflammatory responses. We used the synergistic effect of both proteins to treat COVID-19.
Methods
We conducted an open-label, randomized, clinical trial involving patients with moderate COVID-19. Patients were assigned in a 1:1 ratio to receive either aerosol inhalation treatment with IFN-κ and TFF2 every 24 h for six consecutive dosages in addition to standard care (experimental group) or standard care alone (control group). The primary endpoint was the time until a viral RNA negative conversion for SARS-CoV-2 in all clinical samples. The secondary clinical endpoint was the time of CT imaging improvement. Data analysis was performed per protocol. This study was registered with chictr.org.cn, ChiCTR2000030262.
Findings
Between March 23 and May 23 of 2020, 86 COVID-19 patients with symptoms of moderate illness were recruited, and 6 patients were excluded due to not matching the inclusion criteria (patients with pneumonia through chest radiography). Among the remaining 80 patients, 40 patients were assigned to experimental group, and the others were assigned to control group to only receive standard care. Efficacy and safety were evaluated for both groups. The time of viral RNA negative conversion in experimental group (Mean, 3·80 days, 95% CI 2·07-5·53), was significantly shorter than that in control group (7·40 days, 95% CI 4·57 to 10·23) ( p = 0.031), and difference between means was 3·60 days. The percentage of patients in experimental group with reversion to negative viral RNA was significantly increased compared with control group on all sampling days (every day during the 12-day observation period) ( p = 0·037). For the secondary endpoint, the experimental group had a significantly shorter time until improvement was seen by CT (Mean 6·21 days, N = 38/40, 95% CI 5·11-7·31) than that in control group (8·76 days, N = 34/40, 95% CI 7·57-9·96) ( p = 0.002), and difference between means was 2·55 days. No discomfort or complications during aerosol inhalation were reported to the nurses by any experimental patients.
Interpretation
In conclusion, we found that aerosol inhalation of IFN-κ plus TFF2 in combination with standard care is safe and superior to standard care alone in shortening the time up to viral RNA negative conversion in all clinical samples. In addition, the patients in experimental group had a significantly shortened CT imaging improvement time than those in control group. This study suggested that this combination treatment is able to facilitate clinical improvement (negative for virus, improvement by CT, reduced hospitalization stay) and thereby result in an early release from the hospital. These data support the need for exploration with a large-scale trial of IFN-κ plus TFF2 to treat COVID-19.
Funding
Funding was provided by the National Natural Science Foundation of China, National Major Project for Control and Prevention of Infectious Disease in China, Shanghai Science and Technology Commission, Shanghai Municipal Health Commission.",2020,"38/40, 95% CI 5·11-7·31) than that in control group","['patients with moderate COVID-19', 'Findings\n\n\nBetween March 23 and May 23 of 2020, 86 COVID-19 patients with symptoms of moderate illness were recruited, and 6 patients were excluded due to not matching the inclusion criteria (patients with pneumonia through chest radiography']","['aerosol inhalation treatment with IFN-κ and TFF2 every 24\xa0h for six consecutive dosages in addition to standard care (experimental group) or standard care alone (control group', 'IFN-κ', 'control group to only receive standard care', 'IFN-κ plus TFF2']","['time of viral RNA negative conversion', 'discomfort or complications', 'shorter time until improvement', 'time of CT imaging improvement', 'negative viral RNA', 'Efficacy and safety', 'CT imaging improvement time', 'hospitalization stay', 'time until a viral RNA negative conversion for SARS-CoV-2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}]","[{'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035736', 'cui_str': 'Viral RNA'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",40.0,0.0571901,"38/40, 95% CI 5·11-7·31) than that in control group","[{'ForeName': 'Weihui', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Huiliang', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Zha', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Shimeng', 'Initials': 'S', 'LastName': 'Bai', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Songhua', 'Initials': 'S', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Fengru', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Shang', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Longfei', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Tongyu', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Hongzhou', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, 2901 Caolang Road, Jin Shan District, Shanghai 201508, PR China.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100547']
2967,32985126,How Does the Probability of Purchasing Moderately Sugary Beverages and 100% Fruit Juice Vary Across Sugar Tax Structures?,"OBJECTIVE
Sugar-sweetened beverage taxes are increasingly used to discourage sugar intake; however, the impact on consumer preferences for particular products is largely unknown. This study explored the impact of two tax structures (tiered vs. nontiered and inclusive vs. exclusive of 100% fruit juice) on participants' probability of purchasing moderately sugary beverages and 100% fruit juice.
METHODS
A sample of 3,584 Canadians aged 13 years and older completed a series of beverage purchasing tasks, each corresponding to a different tax condition, within an experimental marketplace. Tax conditions included a no-tax control, plus four taxes varying by structure (tiered vs. nontiered) and whether or not 100% fruit juice was included.
RESULTS
The odds of purchasing a moderately sugary beverage were higher under tiered versus nontiered taxes. Purchases of higher sugar beverages differed little across tiered versus nontiered structures. Odds of purchasing 100% fruit juice were lower when these products were taxed versus not taxed.
CONCLUSIONS
Results suggest that two key tax structures are likely to function as expected; taxes including 100% fruit juice products may lead to lower probability of purchasing fruit juice, and taxes incorporating multiple tiers may be more likely to encourage purchases of moderately sugary products than nontiered formats.",2020,"Odds of purchasing 100% fruit juice were lower when these products were taxed versus not taxed.
","['Tax conditions included a no-tax control, plus four taxes varying by structure (tiered vs. nontiered) and whether or not 100% fruit juice was included', '3,584 Canadians aged 13 years and older completed a series of beverage purchasing tasks, each corresponding to a different tax condition, within an experimental marketplace', ""participants' probability of purchasing moderately sugary beverages and 100% fruit juice""]",['tax structures (tiered vs. nontiered and inclusive vs. exclusive of 100% fruit juice'],[],"[{'cui': 'C0039371', 'cui_str': 'Tax'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0452453', 'cui_str': 'Fruit juice'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0039371', 'cui_str': 'Tax'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0452453', 'cui_str': 'Fruit juice'}]",[],3584.0,0.0522799,"Odds of purchasing 100% fruit juice were lower when these products were taxed versus not taxed.
","[{'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Acton', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Sharon I', 'Initials': 'SI', 'LastName': 'Kirkpatrick', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22992']
2968,32985145,Influence of the laser pulse shape in the treatment of stones in the upper urinary tract.,"PURPOSE
Urinary stones can be successfully treated using a Holmium: Yttrium-Aluminum-Garnet (Ho: YAG) laser. Regarding success rates, laser pulse energy, frequency, and pulse width are well-known contributing factors. Whether the pulse shape might be a further factor influencing the laser efficiency is unclear. This study aimed to evaluate different modes of laser pulse shapes in a real-world setting.
MATERIALS AND METHODS
The Dornier Medilas® H Solvo (Weßling, Germany) was used in the treatment of ureter and kidney stones. Patients were randomized into standard pulse shape (SPS) and new pulse shape groups (NPS1; ureter) and (NPS2; kidney pelvis), depending on the stone localization. The primary endpoint was laser efficiency defined as mm³ stone destruction per overall operating time. Secondary endpoints encompassed number of stone recoveries and stone-free rate.
RESULTS
Altogether 145 patients (24 SPS vs. 32 NPS1; 51 SPS vs. 38 NPS2) were included. No differences in sex, age, body mass index, stone localization and stone composition were found, except for preoperative stone size (133±95 [SPS] vs. 197±139 [NPS1] mm³; p=0.023) and (348±298 [SPS] vs. 525±429 [NPS2] mm³; p=0.042). Regarding the primary endpoint, a significant increase in laser efficiency could be detected for the NPS1 and NPS2 groups compared to the SPS groups (39.9±44.9 vs. 28.8±30.2 and 51.7±61.3 vs. 22.4±24.2 mm³/min [mean±standard deviation]). No statistically significant differences were found for secondary endpoints and perioperative complication rates.
CONCLUSIONS
Efficiency of the Ho: YAG laser can be positively influenced by different pulse shapes. This adds the variable of individualized intraoperative decision making.",2020,"Regarding the primary endpoint, a significant increase in laser efficiency could be detected for the NPS1 and NPS2 groups compared to the SPS groups (39.9±44.9 vs. 28.8±30.2 and 51.7±61.3 vs. 22.4±24.2",['Altogether 145 patients (24 SPS vs. 32 NPS1; 51 SPS vs. 38 NPS2) were included'],"['Holmium: Yttrium-Aluminum-Garnet ', 'standard pulse shape (SPS) and new pulse shape groups (NPS1; ureter) and (NPS2; kidney pelvis', 'laser pulse shape']","['sex, age, body mass index, stone localization and stone composition', 'success rates, laser pulse energy, frequency, and pulse width', 'perioperative complication rates', 'laser efficiency defined as mm³ stone destruction per overall operating time', 'laser efficiency', 'number of stone recoveries and stone-free rate']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0027341', 'cui_str': 'Nail-patella syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0019846', 'cui_str': 'Holmium'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027341', 'cui_str': 'Nail-patella syndrome'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1289835', 'cui_str': 'Pulsed laser device'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0428447', 'cui_str': 'Determination of stone composition'}, {'cui': 'C1289835', 'cui_str': 'Pulsed laser device'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449790', 'cui_str': 'Number of stones'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",145.0,0.0242703,"Regarding the primary endpoint, a significant increase in laser efficiency could be detected for the NPS1 and NPS2 groups compared to the SPS groups (39.9±44.9 vs. 28.8±30.2 and 51.7±61.3 vs. 22.4±24.2","[{'ForeName': 'Abdulmajeed', 'Initials': 'A', 'LastName': 'Alghamdi', 'Affiliation': 'Department of Urology, Ludwig-Maximilians-University (LMU), Munich, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kretschmer', 'Affiliation': 'Department of Urology, Ludwig-Maximilians-University (LMU), Munich, Germany.'}, {'ForeName': 'Christian G', 'Initials': 'CG', 'LastName': 'Stief', 'Affiliation': 'Department of Urology, Ludwig-Maximilians-University (LMU), Munich, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Strittmatter', 'Affiliation': 'Department of Urology, Ludwig-Maximilians-University (LMU), Munich, Germany. frank.strittmatter@med.uni-muenchen.de.'}]",Investigative and clinical urology,['10.4111/icu.20200130']
2969,32980558,The Effect of Laser Acupuncture on Spasticity in Children with Spastic Cerebral Palsy.,"BACKGROUND
Spasticity in cerebral palsy is one of the most common disabilities of children in developing countries.
OBJECTIVES
The objective of this study was to determine the efficacy of laser acupuncture on spasticity in children with spastic cerebral palsy.
METHODS
This clinical trial was conducted on 60 patients with spastic cerebral palsy at 2 to 10 years. The patients were categorized into two groups: the control group and treatment group. Laser acupuncture was applied on GV20, GV14, LI4, GB34, and LR3 (power 50 mW, 785 nm, 1 Joule, 40 seconds) three times a week for 12 sessions in the treatment group and placebo laser acupuncture on the same points in the control group. The spasticity was measured using the Modified Ashworth Scale before and after complete sessions.
RESULTS
The results showed that there was a significant reduction in the Modified Ashworth Scale score in the treatment group compared with the control group (p = 0.003).
CONCLUSIONS
This study suggest that laser acupuncture on GV20, GV14, LI4, GB34, and LR3 can reduce spasticity for children with spastic cerebral palsy.",2020,"The results showed that there was a significant reduction in MAS score in treatment group compared to control group (p=0.003).
","['Children with Spastic Cerebral Palsy', '60 spastic cerebral palsy patients at 2 to 10 years', 'children with spastic cerebral palsy']","['placebo laser acupuncture', 'laser acupuncture', 'Laser acupuncture', 'Laser Acupuncture']","['Modified Ashworth Scale (MAS', 'MAS score', 'GV20, GV14, LI4, GB34 and LR3 ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0394654', 'cui_str': 'Laser acupuncture'}]","[{'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0450800', 'cui_str': 'GV20'}, {'cui': 'C0450794', 'cui_str': 'GV14'}, {'cui': 'C0450480', 'cui_str': 'LI4'}, {'cui': 'C0450754', 'cui_str': 'GB34'}, {'cui': 'C0450768', 'cui_str': 'LR3'}]",,0.0265474,"The results showed that there was a significant reduction in MAS score in treatment group compared to control group (p=0.003).
","[{'ForeName': 'Dian E', 'Initials': 'DE', 'LastName': 'Putri', 'Affiliation': 'Department of Medical Acupuncture, Faculty of Medicine, University of Indonesia, Jalan Diponegoro no. 71, Central Jakarta, Indonesia. Electronic address: d1anputri603@gmail.com.'}, {'ForeName': 'Adiningsih', 'Initials': 'A', 'LastName': 'Srilestari', 'Affiliation': 'Department of Medical Acupuncture, Faculty of Medicine, University of Indonesia, Jalan Diponegoro no. 71, Central Jakarta, Indonesia.'}, {'ForeName': 'Kemas', 'Initials': 'K', 'LastName': 'Abdurrohim', 'Affiliation': 'Department of Medical Acupuncture, Faculty of Medicine, University of Indonesia, Jalan Diponegoro no. 71, Central Jakarta, Indonesia.'}, {'ForeName': 'Irawan', 'Initials': 'I', 'LastName': 'Mangunatmadja', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Indonesia, Jalan Diponegoro no. 71, Central Jakarta, Indonesia.'}, {'ForeName': 'Luh K', 'Initials': 'LK', 'LastName': 'Wahyuni', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, University of Indonesia, Jalan Diponegoro no. 71, Central Jakarta, Indonesia.'}]",Journal of acupuncture and meridian studies,['10.1016/j.jams.2020.09.001']
2970,32980559,The Effects of Auriculotherapy on Shoulder Pain After a Cesarean Section.,"BACKGROUND
Postcesarean section shoulder pain caused by constrained upper extremity movement limits the maternal activities of breastfeeding and neonatal care.
OBJECTIVES
This study aims at investigating the effects of auriculotherapy on shoulder pain after a cesarean section.
METHODS
In this randomized controlled trial, 90 candidates for a cesarean section were selected according to the inclusion and exclusion criteria and randomly allocated into control and intervention groups by the minimization method. In the intervention group, ear seeds were placed on shoulder and muscle relaxation points from two hours prior to surgery until 24 hours after it. In the control group, ear seeds were placed on placebo points. Shoulder pain was assessed on a numerical pain scale in 1, 6, and 24 hours after surgery.
RESULTS
There was no significant difference between the two groups 1 and 6 hours after surgery. However, there was a significant difference between the two groups 24 hours after surgery and the mean pain score was lower in the intervention group (independent t-test, p < 0.001).
CONCLUSION
The use of auriculotherapy is recommended for the prevention and alleviation of shoulder pain after a cesarean section.",2020,"However, there was a significant difference between the two groups 24 hours after surgery and the mean pain score was lower in the intervention group (independent t-test, p < 0.001).
","['shoulder pain after cesarean section', '90 candidates for a cesarean section']",['auriculotherapy'],"['mean pain score', 'Shoulder pain', 'shoulder pain', 'numerical pain scale']","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C2350276', 'cui_str': 'Auriculotherapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",90.0,0.0763085,"However, there was a significant difference between the two groups 24 hours after surgery and the mean pain score was lower in the intervention group (independent t-test, p < 0.001).
","[{'ForeName': 'Abedini', 'Initials': 'A', 'LastName': 'Maryam', 'Affiliation': 'Critical Care Nursing Student, School of Nursing and Midwifery; Student Research Committee, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Aminzadeh', 'Initials': 'A', 'LastName': 'Fariba', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Nicknafs Educational and Treatment Hospital, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Manshoori', 'Initials': 'M', 'LastName': 'Azita', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Nicknafs Educational and Treatment Hospital, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Bakhtar', 'Initials': 'B', 'LastName': 'Babak', 'Affiliation': 'Department of Management of Treatment, Iran Social Security Organization, Rafsanjan, Iran.'}, {'ForeName': 'Sadeghi', 'Initials': 'S', 'LastName': 'Tabandeh', 'Affiliation': 'Department of Pediatric Nursing, School of Nursing and Midwifery, Non-Communicable Diseases Research Center, Rafsanjan University of Medical Sciences, Rafsanjan, Iran. Electronic address: t.sadeghi@rums.ac.ir.'}]",Journal of acupuncture and meridian studies,['10.1016/j.jams.2020.09.002']
2971,32980586,Desire to drink as a function of laboratory-induced social stress among adolescents.,"BACKGROUND AND OBJECTIVES
Research consistently demonstrates a link between social anxiety and alcohol-related problems; however, the majority of work has been retrospective, and conducted with adults. Despite an extensive literature highlighting coping-related motives as an underlying mechanism, real-time work presents mixed findings, and no published research has examined an adolescent sample using experimental psychopathology techniques.
METHODS
The current study tested whether (1) history of social anxiety symptoms positively correlated with alcohol-related cognitions following laboratory-induced social stress, (2) state anxiety was positively correlated with alcohol-related cognitions, and (3) whether the nature of the stressor (performance versus rejection) impacted the strength of identified relations, in a sample of community-recruited adolescents reporting recent alcohol use. Participants (n = 114; M age = 16.01; 64% girls) were randomly assigned to either a performance- or rejection-oriented task.
RESULTS
Findings indicated that history of social anxiety symptoms was positively correlated with state anxiety elicited by both tasks. Further, history of social anxiety symptoms was not related to change in desire to drink, but was positively related to the belief that alcohol 'would make me feel better.' State anxiety was positively related to both desire to drink and relief outcome expectancies across both tasks. Finally, the nature of the task did not moderate responding.
LIMITATIONS
Single site, community sampling confines interpretations, and the tasks did not fully perform as expected.
CONCLUSIONS
Further study is needed; however, the current findings support the contention that socially-oriented distress may be a developmentally-relevant, malleable target for prevention efforts aimed at problematic alcohol use among adolescents.",2020,State anxiety was positively related to both desire to drink and relief outcome expectancies across both tasks.,"['114; M age \xa0=\xa016.01; 64% girls', 'adolescents', 'Participants (n\xa0']",['performance- or rejection-oriented task'],"['history of social anxiety symptoms', 'State anxiety']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}]","[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}]",,0.0194071,State anxiety was positively related to both desire to drink and relief outcome expectancies across both tasks.,"[{'ForeName': 'Heidemarie', 'Initials': 'H', 'LastName': 'Blumenthal', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: heidemarie.blumenthal@unt.edu.'}, {'ForeName': 'Renee M', 'Initials': 'RM', 'LastName': 'Cloutier', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: ReneeCloutier@my.unt.edu.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Douglas', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: MeganDouglas@my.unt.edu.'}, {'ForeName': 'Nathan T', 'Initials': 'NT', 'LastName': 'Kearns', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: NathanKearns@my.unt.edu.'}, {'ForeName': 'Caitlyn N', 'Initials': 'CN', 'LastName': 'Carey', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: CaitlynCarey@my.unt.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101617']
2972,32980788,Acceptability of real-time video counselling compared to other behavioural interventions for smoking cessation in rural and remote areas.,"BACKGROUND
This study evaluated the acceptability of real-time video counselling compared to a) telephone counselling and b) written materials in assisting rural and remote residents to quit smoking.
METHODS
Participants were recruited into a three-arm, parallel group randomised trial and randomly allocated to either: a) real-time video counselling; b) telephone counselling; or c) written materials. At 4-months post-baseline participants completed an online survey that examined self-reported acceptability and helpfulness of the support.
RESULTS
Overall, 93.5 % of video counselling participants and 96.2 % of telephone counselling participants who received support thought it was acceptable for a smoking cessation advisor to contact them via video software or telephone respectively. There were significant differences between video counselling and telephone counselling groups on three of 10 acceptability or helpfulness measures. Video counselling participants had significantly lower odds of reporting the number of calls were about right (OR 0.50, 95 % CI 0.27-0.93), recommending the support to family and friends (OR 0.18, 95 % CI 0.04-0.85) and reporting the support helped with motivation to try quitting (OR 0.24, 95 % CI 0.07-0.76) compared to telephone counselling participants. Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
CONCLUSIONS
Real-time video counselling for smoking cessation is acceptable and well-received by those living in rural and remote locations. Further research is required to enhance the three attributes that were less acceptable for video counselling than telephone counselling.",2020,"Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
","['Participants', 'smoking cessation in rural and remote areas', 'assisting rural and remote residents to quit smoking']","['behavioural interventions', 'real-time video counselling compared to a) telephone counselling and b) written materials', 'real-time video counselling; b) telephone counselling; or c) written materials', 'Video counselling', 'real-time video counselling', 'video counselling']",['number of calls'],"[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",,0.115344,"Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Byaruhanga', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia. Electronic address: Judith.byaruhanga@uon.edu.au.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Byrnes', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108296']
2973,32989941,Design of the Redefining Therapy in Early COPD Study.,"Redefining Therapy in Early COPD (RETHINC) is a 12-week multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily in symptomatic current and former smokers with respiratory symptoms as defined by COPD Assessment Test (CAT) score ≥ 10 despite preserved spirometry defined by post-bronchodilator forced expiratory volume in 1 second (FEV 1 ) to forced vital capacity (FVC) ratio ≥ 0.70. Recruitment began in July 2017 with the goal of enrolling 580 participants. The baseline examination includes spirometry (with slow and forced maneuvers) and symptom questionnaires. A follow-up phone call at 4 weeks assesses symptoms and safety. The second and final visit at week 12 includes spirometry before and after study drug (hourly over 3 hours) and follow-up symptom questionnaires. The primary endpoint is the proportion of individuals who experience a 4-unit improvement in St George's Respiratory Questionnaire (SGRQ) score at 12 weeks without treatment failure, defined as an increase in lower respiratory symptoms necessitating treatment with active, long-acting inhaled bronchodilators, corticosteroids or antibiotics. Key secondary endpoints include the proportion of individuals with a 2-unit improvement in the CAT score; 1-unit improvement in the Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI), both a 4-unit improvement in SGRQ and a 1-unit improvement in BDI/TDI; and mean change in SGRQ, CAT and BDI/TDI. Other secondary endpoints include area under the curve 0-3 hours for FEV 1 after study drug, change from baseline in trough inspiratory capacity, forced expiratory flow 25%-75% of FVC (FEF 25-75 ) iso-volume FEF 25-75 and mean change in symptoms and rescue medication use based on daily diary. We anticipate results to be available in 2021. This paper describes the RETHINC study and explains the rationale behind it.",2020,"Redefining Therapy in Early COPD (RETHINC) is a 12-week multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily in symptomatic current and former smokers with respiratory symptoms as defined by COPD Assessment Test (CAT) score ≥ 10 despite preserved spirometry defined by post-bronchodilator forced expiratory volume in 1 second (FEV 1 ) to forced vital capacity (FVC) ratio ≥ 0.70.",['Recruitment began in July 2017 with the goal of enrolling 580 participants'],"['indacaterol/glycopyrrolate', 'placebo']","['COPD Assessment Test (CAT) score', 'efficacy and safety', 'area under the curve 0-3 hours for FEV 1 after study drug, change from baseline in trough inspiratory capacity, forced expiratory flow 25%-75% of FVC', 'proportion of individuals with a 2-unit improvement in the CAT score; 1-unit improvement in the Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI), both a 4-unit improvement in SGRQ and a 1-unit improvement in BDI/TDI; and mean change in SGRQ, CAT and BDI/TDI', ""proportion of individuals who experience a 4-unit improvement in St George's Respiratory Questionnaire (SGRQ) score"", 'lower respiratory symptoms necessitating treatment with active, long-acting inhaled bronchodilators, corticosteroids or antibiotics', 'baseline examination includes spirometry (with slow and forced maneuvers) and symptom questionnaires']","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C4517818', 'cui_str': '580'}]","[{'cui': 'C4058826', 'cui_str': 'glycopyrronium / indacaterol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",580.0,0.221688,"Redefining Therapy in Early COPD (RETHINC) is a 12-week multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily in symptomatic current and former smokers with respiratory symptoms as defined by COPD Assessment Test (CAT) score ≥ 10 despite preserved spirometry defined by post-bronchodilator forced expiratory volume in 1 second (FEV 1 ) to forced vital capacity (FVC) ratio ≥ 0.70.","[{'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Michigan, Ann Arbor.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Ye', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor.'}, {'ForeName': 'Dong-Yun', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Prescott', 'Initials': 'P', 'LastName': 'Woodruff', 'Affiliation': 'Division of Pulmonary and Critical Care, University of California, San Francisco.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Chronic obstructive pulmonary diseases (Miami, Fla.)",['10.15326/jcopdf.7.4.2020.0157']
2974,32990891,The Influence of Physiological and Psychological Learning Mechanisms in Neurofeedback vs. Mental Imagery Against Binge Eating.,"In biofeedback research, the debate on physiological versus psychological learning has a long tradition and is still relevant today, regarding new developments of biofeedback for behavior modification. Analyzing the role of these learning mechanisms may help improving the protocols and answer the question, whether feedback of physiological functions is necessary to modify a target behavior. We explored the presence and impact of physiological (EEG changes) versus psychological learning (changes in somatic self-efficacy) in a recently developed EEG neurofeedback protocol for binge eating. The protocol targets a reduction of food-cue induced cortical arousal through regulation of EEG high beta activity. In an experimental study accompanying a randomized controlled trial, pre and post treatment EEG measurements were analyzed in a neurofeedback group (n = 18) and an active mental imagery control group without physiological feedback (n = 18). Physiological learning in terms of EEG high beta reduction only occurred in the neurofeedback group. Post treatment, participants with successfully reduced binge eating episodes (≥ 50% reduction) showed lower EEG high beta activity than unsuccessful participants (p = .02) after neurofeedback, but not after mental imagery. Further, lower EEG high beta activity at post-treatment predicted fewer binge eating episodes in neurofeedback only. In mental imagery, somatic self-efficacy predicted treatment success instead of EEG activity. Altogether, the results indicate that physiological changes serve as a specific treatment mechanism in neurofeedback against binge eating. Reducing cortical arousal may improve eating behaviors and corresponding neurofeedback techniques should therefore be considered in future treatments.",2020,"Post treatment, participants with successfully reduced binge eating episodes (≥ 50% reduction) showed lower EEG high beta activity than unsuccessful participants (p = .02) after neurofeedback, but not after mental imagery.","['n\u2009=\u200918', 'binge eating', 'Neurofeedback vs. Mental Imagery Against Binge Eating']","['active mental imagery control group without physiological feedback', 'physiological (EEG\xa0changes) versus psychological learning']","['lower EEG high beta activity', 'binge eating episodes', 'eating behaviors']","[{'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2713398', 'cui_str': 'Feedback, Physiological'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",,0.0476151,"Post treatment, participants with successfully reduced binge eating episodes (≥ 50% reduction) showed lower EEG high beta activity than unsuccessful participants (p = .02) after neurofeedback, but not after mental imagery.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'HSD Hochschule Döpfer University of Applied Sciences, Waidmarkt 3 & 9, 50676, Cologne, Germany. j.schmidt@hs-doepfer.de.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Clinical Psychology and Psychotherapy, University of Wuppertal, Wuppertal, Germany.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-020-09486-9']
2975,32990938,Extended-Release Dinalbuphine Sebacate Versus Intravenous Patient-Controlled Analgesia with Fentanyl for Postoperative Moderate-to-Severe Pain: A Randomized Controlled Trial.,"INTRODUCTION
Post-operative pain control remains unsatisfactory in patients after laparotomy. This study aimed to evaluate the efficacy, safety, and quality of life with a single dose of extended-release dinalbuphine sebacate (ERDS) pre-operatively to intravenous patient-controlled analgesia (PCA) with fentanyl in patients undergoing laparotomy.
METHODS
This was a prospective, open-label, randomized controlled study. Of 110 randomized patients, 107 completed all assessments. The area under the curve (AUC) of visual analogue scale (VAS) from baseline to 48 h after surgery, VAS throughout 7 days after surgery, post-operative analgesics use, quality of life, satisfaction, and safety were evaluated.
RESULTS
The AUC of VAS from baseline to 48 h after surgery were 118.6 [97.5% confidence interval (CI) 95.6-141.6] in ERDS group and 176.13 (97.5% CI 150.8-201.4) in PCA group, which showed the non-inferiority because the upper limit of the 97.5% CIs of ERDS group was lower than the lower limit of PCA group (P < 0.001), but also had superiority in favor of ERDS group (P < 0.001). ERDS group reported a significant reduction in VAS pain intensity at 4, 24, 32, 72, 120, and 144 h after surgery, and better quality of life (P < 0.05). The safety profile was comparable between ERDS and PCA groups.
CONCLUSIONS
In patients undergoing laparotomy, a single dose of dinalbuphine sebacate was superior to intravenous PCA with fentanyl on lower pain intensity and better quality of life.
TRIAL REGISTRATION
NCT03296488.",2020,"RESULTS
The AUC of VAS from baseline to 48 h after surgery were 118.6 [97.5% confidence interval (CI) 95.6-141.6] in ERDS group and 176.13 (97.5% CI 150.8-201.4) in PCA group, which showed the non-inferiority because the upper limit of the 97.5% CIs of ERDS group was lower than the lower limit of PCA group (P < 0.001), but also had superiority in favor of ERDS group (P < 0.001).","['Postoperative Moderate-to-Severe Pain', 'patients after laparotomy', 'Of 110 randomized patients, 107 completed all assessments', 'patients undergoing laparotomy']","['ERDS', 'extended-release dinalbuphine sebacate (ERDS) pre-operatively to intravenous patient-controlled analgesia (PCA) with fentanyl', 'Dinalbuphine Sebacate Versus Intravenous Patient-Controlled Analgesia with Fentanyl', 'PCA with fentanyl', 'dinalbuphine sebacate']","['safety profile', 'area under the curve (AUC) of visual analogue scale (VAS', 'efficacy, safety, and quality of life', 'AUC of VAS', 'pain intensity and better quality of life', 'quality of life', 'quality of life, satisfaction, and safety', 'VAS pain intensity']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0946377', 'cui_str': 'sebacate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",110.0,0.166089,"RESULTS
The AUC of VAS from baseline to 48 h after surgery were 118.6 [97.5% confidence interval (CI) 95.6-141.6] in ERDS group and 176.13 (97.5% CI 150.8-201.4) in PCA group, which showed the non-inferiority because the upper limit of the 97.5% CIs of ERDS group was lower than the lower limit of PCA group (P < 0.001), but also had superiority in favor of ERDS group (P < 0.001).","[{'ForeName': 'Tsung-Kun', 'Initials': 'TK', 'LastName': 'Chang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Ching-Wen', 'Initials': 'CW', 'LastName': 'Huang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Wei-Chih', 'Initials': 'WC', 'LastName': 'Su', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Hsiang-Lin', 'Initials': 'HL', 'LastName': 'Tsai', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Cheng-Jen', 'Initials': 'CJ', 'LastName': 'Ma', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Yung-Sung', 'Initials': 'YS', 'LastName': 'Yeh', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Yen-Cheng', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Ching-Chun', 'Initials': 'CC', 'LastName': 'Li', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Kuang-I', 'Initials': 'KI', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Miao-Pei', 'Initials': 'MP', 'LastName': 'Su', 'Affiliation': 'Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Jaw-Yuan', 'Initials': 'JY', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan. cy614112@ms14.hinet.net.'}]",Pain and therapy,['10.1007/s40122-020-00197-x']
2976,32987642,"Effects of a Low-Fat Vegan Diet on Gut Microbiota in Overweight Individuals and Relationships with Body Weight, Body Composition, and Insulin Sensitivity. A Randomized Clinical Trial.","Diet modulates gut microbiota and plays an important role in human health. The aim of this study was to test the effect of a low-fat vegan diet on gut microbiota and its association with weight, body composition, and insulin resistance in overweight men and women. We enrolled 168 participants and randomly assigned them to a vegan ( n = 84) or a control group ( n = 84) for 16 weeks. Of these, 115 returned all gut microbiome samples. Gut microbiota composition was assessed using uBiome Explorer™ kits. Body composition was measured using dual energy X-ray absorptiometry. Insulin sensitivity was quantified with the predicted clamp-derived insulin sensitivity index from a standard meal test. Repeated measure ANOVA was used for statistical analysis. Body weight decreased in the vegan group (treatment effect -5.9 kg [95% CI, -7.0 to -4.9 kg]; p < 0.001), mainly due to a reduction in fat mass (-3.9 kg [95% CI, -4.6 to -3.1 kg]; p < 0.001) and in visceral fat (-240 cm 3 [95% CI, -345 to -135 kg]; p < 0.001). PREDIcted M, insulin sensitivity index (PREDIM) increased in the vegan group (treatment effect +0.83 [95% CI, +0.48 to +1.2]; p < 0.001). The relative abundance of Faecalibacterium prausnitzii increased in the vegan group (+5.1% [95% CI, +2.4 to +7.9%]; p < 0.001) and correlated negatively with changes in weight (r = -0.24; p = 0.01), fat mass (r = -0.22; p = 0.02), and visceral fat (r = -0.20; p = 0.03). The relative abundance of Bacteroides fragilis decreased in both groups, but less in the vegan group, making the treatment effect positive (+18.9% [95% CI, +14.2 to +23.7%]; p < 0.001), which correlated negatively with changes in weight (r = -0.44; p < 0.001), fat mass (r = -0.43; p < 0.001), and visceral fat (r = -0.28; p = 0.003) and positively with PREDIM (r = 0.36; p < 0.001), so a smaller reduction in Bacteroides fragilis was associated with a greater loss of body weight, fat mass, visceral fat, and a greater increase in insulin sensitivity. A low-fat vegan diet induced significant changes in gut microbiota, which were related to changes in weight, body composition, and insulin sensitivity in overweight adults, suggesting a potential use in clinical practice.",2020,"PREDIcted M, insulin sensitivity index (PREDIM) increased in the vegan group (treatment effect +0.83","['overweight men and women', '168 participants and randomly assigned them to a vegan ( n = 84) or a', 'human health']","['low-fat vegan diet', 'Low-Fat Vegan Diet', 'control group']","['weight, body composition, and insulin sensitivity', 'gut microbiota', 'gut microbiota and its association with weight, body composition, and insulin resistance', 'fat mass', 'Gut microbiota composition', 'relative abundance of Faecalibacterium prausnitzii', 'relative abundance of Bacteroides fragilis', 'Body composition', 'Gut Microbiota in Overweight Individuals and Relationships with Body Weight, Body Composition, and Insulin Sensitivity', 'Insulin sensitivity', 'changes in weight', 'body weight, fat mass, visceral fat', 'visceral fat', 'Body weight', 'insulin sensitivity', 'M, insulin sensitivity index (PREDIM']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0344353', 'cui_str': 'Vegan'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0317558', 'cui_str': 'Faecalibacterium prausnitzii'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",168.0,0.123136,"PREDIcted M, insulin sensitivity index (PREDIM) increased in the vegan group (treatment effect +0.83","[{'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Kahleova', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC 20016, USA.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Rembert', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC 20016, USA.'}, {'ForeName': 'Jihad', 'Initials': 'J', 'LastName': 'Alwarith', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC 20016, USA.'}, {'ForeName': 'Willy N', 'Initials': 'WN', 'LastName': 'Yonas', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC 20016, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tura', 'Affiliation': 'Metabolic Unit, CNR Institute of Neuroscience, 35127 Padua, Italy.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holubkov', 'Affiliation': 'School of Medicine, University of Utah, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Agnello', 'Affiliation': 'uBiome Inc., San Francisco, CA 94103, USA.'}, {'ForeName': 'Robynne', 'Initials': 'R', 'LastName': 'Chutkan', 'Affiliation': 'Department of Gastroenterology, Georgetown MedStar Hospital, Washington, DC 20007, USA.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Barnard', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC 20016, USA.'}]",Nutrients,['10.3390/nu12102917']
2977,32989176,β-lactolin increases cerebral blood flow in dorsolateral prefrontal cortex in healthy adults: a randomized controlled trial.,"The number of elderly individuals with age-related cognitive decline or dementia is rapidly increasing. Dairy product consumption, including β-lactolin, is beneficial for their cognitive function. The underlying mechanism of β-lactolin's effects on human brain activity is yet to be investigated. We examined the β-lactolin effects on human cerebral blood flow (CBF) using near-infrared spectroscopy (NIRS) in a placebo-controlled randomized double-blind study, which reported according to the CONSORT guidelines. Fifty healthy participants (aged 45-60 years) were randomly allocated into the β-lactolin or the placebo group (n = 25 each) and supplemented for 6 weeks. During the 6 th week, oxy-hemoglobin during the working memory tasks was measured using 34-channels (CHs) NIRS. The changes of oxy-hemoglobin, which represents the CBF, in CH 23 located at the left dorsolateral prefrontal cortex (DLPFC) during the spatial working memory task showed higher statistical significance (false discovery rate ( q ) = 0.045) in the β-lactolin than in the placebo group. The oxy-Hb changes in CH23 have a co-relationship with the working memory task reaction time. This clinical trial showed an increase in the CBF in the left DLPFC area during the 6-week β-lactolin supplementation. This study contributes to elucidating the underlying mechanisms of β-lactolin on cognitive performance.",2020,"The changes of oxy-hemoglobin, which represents the CBF, in CH 23 located at the left dorsolateral prefrontal cortex (DLPFC) during the spatial working memory task showed higher statistical significance (false discovery rate ( q ) = 0.045) in the β-lactolin than in the placebo group.","['healthy adults', 'Fifty healthy participants (aged 45-60 years', 'elderly individuals with age-related cognitive decline or dementia']","['β-lactolin', 'placebo']","['cognitive performance', 'human cerebral blood flow (CBF', 'cerebral blood flow', 'changes of oxy-hemoglobin']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0236848', 'cui_str': 'Age-related cognitive decline'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",50.0,0.105533,"The changes of oxy-hemoglobin, which represents the CBF, in CH 23 located at the left dorsolateral prefrontal cortex (DLPFC) during the spatial working memory task showed higher statistical significance (false discovery rate ( q ) = 0.045) in the β-lactolin than in the placebo group.","[{'ForeName': 'Yasuhisa', 'Initials': 'Y', 'LastName': 'Ano', 'Affiliation': 'Kirin Central Research Institute, Kirin Holdings Company, Ltd., Kanazawa-ku, Yokohama 236-0004, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Kirin Central Research Institute, Kirin Holdings Company, Ltd., Kanazawa-ku, Yokohama 236-0004, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Hanyuda', 'Affiliation': 'Breast Health Clinic, Chuo-ku, Tokyo 103-0025, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Kawashima', 'Affiliation': 'Institute of Development, Aging and Cancer (IDAC), Tohoku University, Aoba-ku, Sendai 980-0872, Japan.'}]",Aging,['10.18632/aging.103951']
2978,32986682,The D1/D5 Dopamine Partial Agonist PF-06412562 in Advanced-Stage Parkinson's Disease: A Feasibility Study.,"BACKGROUND
Current drug treatments have little efficacy in advanced-to-end-stage Parkinson's disease (advPD), yet there are no reports of interventional trials in advPD. D1 dopamine agonists have the potential to provide benefit.
OBJECTIVE
To determine the feasibility and safety of the selective D1/D5 dopamine partial agonist PF 06412562 in advPD.
METHODS
A two-week, randomized, double blind, crossover phase Ib study in advPD patients compared standard-of-care (SoC) carbidopa/levodopa with PF 06412562. Each week, there was a Day 1 baseline evaluation with overnight levodopa washout, then treatment on Days 2 and 3 with either SoC or PF-06412562 (split dose 25 + 20 mg), followed by discharge on Day 4. Primary endpoints were safety and tolerability. Secondary endpoints were global clinical impression of change (GCI-C) rated by clinicians and caregivers.
RESULTS
Eight advPD patients and their caregivers consented to participate and six were randomized (average disease duration: 22 y). None withdrew voluntarily. One participant with baseline Day 1 dehydration, pre-renal kidney injury, and autonomic dysfunction experienced symptomatic and serious hypotension after receiving PF-06412562 in Week 1 and was discontinued from the study. All other adverse events were rated mild (PF-06412562: n = 1, SoC: n = 0), moderate (PF-06412562: n = 1, SoC: n = 1), or severe but non-serious (PF-06412562: n = 3, SoC: n = 2). No clinically meaningful laboratory changes were observed. Among the five participants who completed the study, GCI-C favored PF-06412562 in two per clinicians' and four participants per caregivers' rating.
CONCLUSION
PF-06412562 was tolerated in advPD patients. This study provides the feasibility for future safety and efficacy studies in this population with unmet needs.",2020,No clinically meaningful laboratory changes were observed.,"['Eight advPD patients and their caregivers consented to participate and six were randomized (average disease duration: 22\u200ay', ""Advanced-Stage Parkinson's Disease"", 'advPD patients']","['SoC or PF-06412562', 'D1/D5 Dopamine Partial Agonist PF-06412562', 'PF-06412562', 'standard-of-care (SoC) carbidopa/levodopa with PF 06412562']","['safety and tolerability', 'renal kidney injury, and autonomic dysfunction experienced symptomatic and serious hypotension', 'global clinical impression of change (GCI-C) rated by clinicians and caregivers']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4049471', 'cui_str': ""End stage Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0013363', 'cui_str': 'Dysautonomia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",,0.156913,No clinically meaningful laboratory changes were observed.,"[{'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Mechelle M', 'Initials': 'MM', 'LastName': 'Lewis', 'Affiliation': 'Department of Neurology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Lauren Jodi', 'Initials': 'LJ', 'LastName': 'Van Scoy', 'Affiliation': 'Department of Medicine, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Sol', 'Initials': 'S', 'LastName': 'De Jesus', 'Affiliation': 'Department of Neurology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Eslinger', 'Affiliation': 'Department of Neurology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Arnold', 'Affiliation': 'Department of Neural and Behavioral Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Miller', 'Affiliation': 'Department of Neural and Behavioral Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Fernandez-Mendoza', 'Affiliation': 'Department of Neural and Behavioral Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Snyder', 'Affiliation': 'Department of Neurology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Harrington', 'Affiliation': 'Department of Neurology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Kong', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Dongxiao', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Pharmacology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Delnomdedieu', 'Affiliation': 'Pfizer Inc., Cambridge, MA, USA.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Duvvuri', 'Affiliation': 'Cerevel Neurosciences LLC., Boston, MA, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Mahoney', 'Affiliation': 'Pfizer Inc., Cambridge, MA, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Gray', 'Affiliation': 'Cerevel Neurosciences LLC., Boston, MA, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Mailman', 'Affiliation': 'Department of Neurology, Penn State College of Medicine, Hershey, PA, USA.'}]",Journal of Parkinson's disease,['10.3233/JPD-202188']
2979,32986685,Predictors of Conversion to α-Synucleinopathy Diseases in Idiopathic Rapid Eye Movement Sleep Behavior Disorder.,"BACKGROUND
Idiopathic rapid eye movement sleep behavior disorder (iRBD) often precedes the development of α-synucleinopathy diseases.
OBJECTIVE
We aimed to assess the predictive value of clinical variables and biomarkers for the early development of α-synucleinopathy diseases in subjects with iRBD.
METHODS
56 patients with RBD Screening Questionnaire (RBDSQ) scores ≥5 at baseline and subsequent visit were enrolled as probable iRBD from the Parkinson's Progression Markers Initiative (PPMI) database. Baseline clinical data and biomarkers were analyzed. The endpoint was defined as disease progression to α-synucleinopathy diseases. Cox proportional hazard and Kaplan-Meier analyses were used to evaluate the predictive values of the indicators.
RESULTS
During a mean follow-up duration of 5.1 years, 15 of 56 patients (26.8%) developed α-synucleinopathy diseases. Baseline clinical variables, including University of Pennsylvania Smell Identification Test (UPSIT, HR = 26.18, p = 0.004), 15-item Geriatric Depression Scale (GDS, HR = 14.26, p = 0.001), Montreal Cognitive Assessment (MoCA, HR = 3.56, p = 0.025), and Hopkins Verbal Learning Test Total recall (HVLT-TR, HR = 3.70, p = 0.014); genotype status of TMEM175 (HR = 3.74, p = 0.017), SCN3A (HR = 5.81, p = 0.022) and NUCKS1 (HR = 0.342, p = 0.049); ratio of phosphorylated tau to total tau (p-tau/t-tau, HR = 8.36, p = 0.001) in cerebrospinal fluid; and gray matter atrophy in inferior frontal gyrus (IFG, HR = 15.49, p = 0.001) were associated with phenoconversion to α-synucleinopathy diseases. A model combined the three independent variables (UPSIT, TMEM175 and gray matter atrophy in IFG) exhibited significantly improved predictive performance.
CONCLUSION
For patients with iRBD, progression to α-synucleinopathy diseases can be predicted with good accuracy using a model combining clinical variables and biomarkers, which could form a basis for future disease prevention.",2020,"Baseline clinical variables, including University of Pennsylvania Smell Identification Test (UPSIT, HR = 26.18, p = 0.004),","[""56 patients with RBD Screening Questionnaire (RBDSQ) scores ≥5 at baseline and subsequent visit were enrolled as probable iRBD from the Parkinson's Progression Markers Initiative (PPMI) database"", 'Idiopathic Rapid Eye Movement Sleep Behavior Disorder', 'subjects with iRBD', 'Idiopathic rapid eye movement sleep behavior disorder (iRBD']",[],"['disease progression to α-synucleinopathy diseases', 'α-synucleinopathy diseases', 'cerebrospinal fluid; and gray matter atrophy', 'Hopkins Verbal Learning Test Total recall', 'Montreal Cognitive Assessment', '15-item', 'University of Pennsylvania Smell Identification Test', 'Geriatric Depression Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0751772', 'cui_str': 'REM sleep behavior disorder'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C5191670', 'cui_str': 'Synucleinopathy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}]",56.0,0.0393946,"Baseline clinical variables, including University of Pennsylvania Smell Identification Test (UPSIT, HR = 26.18, p = 0.004),","[{'ForeName': 'Guanyu', 'Initials': 'G', 'LastName': 'Ye', 'Affiliation': 'Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Neurology & Institute of Neurology, Ruijin Hospital/Lu Wan Branch, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Liche', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology & Institute of Neurology, Ruijin Hospital/Lu Wan Branch, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yichi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology & Institute of Neurology, Ruijin Hospital/Lu Wan Branch, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Aonan', 'Initials': 'A', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology & Institute of Neurology, Ruijin Hospital/Lu Wan Branch, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Kang', 'Affiliation': 'Department of Neurology, Ruijin Hospital/North Branch, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology & Institute of Neurology, Ruijin Hospital/Lu Wan Branch, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",Journal of Parkinson's disease,['10.3233/JPD-202243']
2980,33002553,Comparative clinical study evaluating the effect of adding Vildagliptin versus Glimepiride to ongoing Metformin therapy on diabetic patients with symptomatic coronary artery disease.,"BACKGROUND AND OBJECTIVE
Cardiovascular diseases (CVDs) remain the most identified cause of death in patients with diabetes mellitus (DM). This study aimed to evaluate the effect of adding Vildagliptin versus Glimepiride to ongoing Metformin on the biomarkers of inflammation, thrombosis, and atherosclerosis in T2DM patients with symptomatic coronary artery disease (CAD).
METHODS
This study included 80 patients with uncontrolled T2DM and symptomatic CAD who were randomized to add either Vildagliptin 50 mg/day ""group I"" or Glimepiride 4 mg/day ""group II"" to ongoing Metformin therapy (1000 mg/day). Blood samples were collected at baseline and 3 months after intervention for biochemical analysis of HbA1c %, IL-1β, adiponectin, hsCRP and lipid profile. Additionally atherogenic index (AI) and coronary risk index (CRI) were determined.
RESULTS
Three months after intervention and as compared to group II (Glimepiride/Metformin), group 1 (Vildagliptin/Metformin) showed significantly lower BMI (28.73 ± 3.48 versus 30.55 ± 3.15; p = 0.02), HbA1c (6.05 ± 0.72 versus 7.06 ± 0.89; p < 0.0001), hsCRP (0.96 ± 0.20 versus 1.72 ± 0.38; p < 0.0001), IL-1β (34.95 ± 10.01 versus 45.13 ± 10.26; p < 0.0001), TC (136 ± 23.45 versus 169 ± 35.72; p < 0.0001), TG (116 ± 29.10 versus 146 ± 56.58; p = 0.005), and CRI (2.47 ± 0.90 versus 3.65 ± 1.19; p < 0.0001) which was associated with significantly higher adiponectin and HDL-C (4.42 ± 1.29 versus 2.52 ± 1.86; p < 0.0001 and 61 ± 23.04 versus 48 ± 12.92; p = 0.003 respectively).
CONCLUSION
In patients with T2DM and symptomatic CAD, the addition of Vildagliptin to ongoing metformin showed better glycemic control, lower inflammatory markers (IL-1β and hsCRP), higher protective markers (adiponectin and HDL-C) and improved lipid profile compared to Glimepiride/metformin therapy.",2020,"In patients with T2DM and symptomatic CAD, the addition of Vildagliptin to ongoing metformin showed better glycemic control, lower inflammatory markers (IL-1β and hsCRP), higher protective markers (adiponectin and HDL-C) and improved lipid profile compared to Glimepiride/metformin therapy.","['T2DM patients with symptomatic coronary artery disease (CAD', 'patients with diabetes mellitus (DM', '80 patients with uncontrolled T2DM and symptomatic CAD', 'Diabetic Patients with Symptomatic Coronary Artery Disease']","['Vildagliptin', 'Glimepiride', 'Glimepiride/metformin', 'Vildagliptin 50 mg/day ""group', 'Metformin therapy', 'Glimepiride/Metformin', 'Vildagliptin/Metformin', 'Metformin Therapy', 'Metformin']","['BMI', 'CRI', 'Additionally atherogenic index (AI) and coronary risk index (CRI', 'glycemic control, lower inflammatory markers (IL-1β and hsCRP), higher protective markers (adiponectin and HDL-C) and improved lipid profile', 'Blood samples', 'adiponectin and HDL-C', 'biomarkers of inflammation, thrombosis, and atherosclerosis', 'hsCRP', 'IL-1β']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2240780', 'cui_str': 'vildagliptin 50 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]",80.0,0.0534605,"In patients with T2DM and symptomatic CAD, the addition of Vildagliptin to ongoing metformin showed better glycemic control, lower inflammatory markers (IL-1β and hsCRP), higher protective markers (adiponectin and HDL-C) and improved lipid profile compared to Glimepiride/metformin therapy.","[{'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Werida', 'Affiliation': 'Clinical Pharmacy & Pharmacy Practice Department, Faculty of Pharmacy, Damanhour University, Egypt. Electronic address: rehabwrieda@pharm.dmu.edu.eg.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Kabel', 'Affiliation': 'Clinical Pharmacy Unit, Alexandria Armed Forces Hospital, Egypt.'}, {'ForeName': 'Gamal', 'Initials': 'G', 'LastName': 'Omran', 'Affiliation': 'Biochemistry Department, Faculty of Pharmacy, Damanhour University, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Shokry', 'Affiliation': 'Cardiology Department, Alexandria Armed Forces Hospital, Egypt.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Mostafa', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Egypt.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108473']
2981,33003299,The GReat-Child Trial TM : A Quasi-Experimental Dietary Intervention among Overweight and Obese Children.,"Diet composition is a key determinant of childhood obesity. While whole grains and micronutrients are known to decrease the risk of obesity, there are no interventions originating from Southeast Asia that emphasize whole grain as a strategy to improve overall quality of diet in combating childhood obesity. The GReat-Child Trial aimed to improve whole grain intake and quality of diet among overweight and obese children. It is a quasi-experimental intervention based on Social Cognitive Theory. It has a 12-week intervention and 6-month follow-up, consisting of three components that address environmental, personal, and behavioral factors. The intervention consists of: (1) six 30 min lessons on nutrition, using the Malaysian Food Pyramid to emphasize healthy eating, (2) daily deliveries of wholegrain foods to schools so that children can experience and accept wholegrain foods, and (3) diet counseling to parents to increase availability of wholegrain foods at home. Two primary schools with similar demographics in Kuala Lumpur were assigned as control (CG) and intervention (IG) groups. Inclusion criteria were: (1) children aged 9 to 11 years who were overweight/obese; (2) who did not consume whole grain foods; and (3) who had no serious co-morbidity problems. The entire trial was completed by 63 children (31 IG; 32 CG). Study outcomes were measured at baseline and at two time points post intervention (at the 3rd [T1] and 9th [T2] months). IG demonstrated significantly higher intakes of whole grain (mean difference = 9.94, 95%CI: 7.13, 12.75, p < 0.001), fiber (mean difference = 3.07, 95% CI: 1.40, 4.73, p = 0.001), calcium (mean difference = 130.27, 95%CI: 74.15, 186.39, p < 0.001), thiamin (mean difference = 58.71, 95%CI: 26.15, 91.28, p = 0.001), riboflavin (mean difference = 0.84, 95%CI: 0.37, 1.32, p = 0.001), niacin (mean difference = 0.35, 95%CI: 1.91, 5.16, p < 0.001), and vitamin C (mean difference = 58.71, 95%CI: 26.15, 91.28, p = 0.001) compared to CG in T1, after adjusting for covariates. However, T1 results were not sustained in T2 when intervention had been discontinued. The findings indicate that intervention emphasizing whole grains improved overall short-term but not long-term dietary intake among schoolchildren. We hope the present trial will lead to adoption of policies to increase whole grain consumption among Malaysian schoolchildren.",2020,"IG demonstrated significantly higher intakes of whole grain (mean difference = 9.94, 95%CI: 7.13, 12.75, p < 0.001), fiber (mean difference = 3.07, 95% CI: 1.40, 4.73, ","['overweight and obese children', 'Inclusion criteria were: (1) children aged 9 to 11 years who were overweight/obese; (2) who did not consume whole grain foods; and (3) who had no serious co-morbidity problems', 'Two primary schools with similar demographics in Kuala Lumpur', 'Overweight and Obese Children', 'Malaysian schoolchildren']","['Quasi-Experimental Dietary Intervention', 'Malaysian Food Pyramid to emphasize healthy eating, (2) daily deliveries of wholegrain foods to schools so that children can experience and accept wholegrain foods, and (3) diet counseling to parents to increase availability of wholegrain foods at home', 'niacin']","['riboflavin', 'intakes of whole grain', 'vitamin C']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}]","[{'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]",1.0,0.066454,"IG demonstrated significantly higher intakes of whole grain (mean difference = 9.94, 95%CI: 7.13, 12.75, p < 0.001), fiber (mean difference = 3.07, 95% CI: 1.40, 4.73, ","[{'ForeName': 'Hui Chin', 'Initials': 'HC', 'LastName': 'Koo', 'Affiliation': 'Nutritional Sciences Programme & Centre for Community Health Studies (ReaCH), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur 50300, Malaysia.'}, {'ForeName': 'Bee Koon', 'Initials': 'BK', 'LastName': 'Poh', 'Affiliation': 'Nutritional Sciences Programme & Centre for Community Health Studies (ReaCH), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur 50300, Malaysia.'}, {'ForeName': 'Ruzita Abd', 'Initials': 'RA', 'LastName': 'Talib', 'Affiliation': 'Nutritional Sciences Programme & Centre for Community Health Studies (ReaCH), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur 50300, Malaysia.'}]",Nutrients,['10.3390/nu12102972']
2982,33004857,Microbiological and host-derived biomarker evaluation following non-surgical periodontal therapy with short-term administration of systemic antimicrobials: secondary outcomes of an RCT.,"Nonsurgical periodontal therapy with adjunctive use of systemic antimicrobials (for 7-14 days) showed improved clinical, microbiological and immunological results over the mechanical protocol alone. Considering the increasing risk for antimicrobial resistance with longer antibiotic regimes, it is important to establish the optimal antibiotic protocol with a maximum antimicrobial benefit and minimum risk for adverse effects. The aim of the study was to evaluate the microbiological and inflammatory outcomes 12-months after a 3-/7-day systemic antibiotic protocol [amoxicillin (AMX) + metronidazole (MET)] adjunctive to subgingival debridement in severe periodontitis compared to mechanical treatment alone. From the initially treated 102 patients, 75 subjects (Placebo group: n = 26; 3-day AMX + MET group: n = 24; 7-day AMX + MET group: n = 25) completed the 12-month examination. Clinical parameters, eight periodontal pathogens and inflammatory markers were determined at baseline and 3-, 6-, 12-months after therapy using real-time PCR and ELISA respectively. After 6 months, several periodontopathogens were significantly more reduced in the two antibiotic groups compared to placebo (p < 0.05). After 1 year, both antibiotic protocols showed significant reductions and detection of the keystone pathogen P. gingivalis compared to placebo. Antibiotic protocols, smoking, disease severity, baseline-BOP, -CAL and -IL-1β, as well as detection of T. denticola at 12-months significantly influenced the residual number of deep sites. The present data indicate that the systemic use of both short and longer antibiotic protocols (AMX + MET) adjunctive to nonsurgical periodontal therapy lead to higher microbiological improvements compared to subgingival debridement alone. The two investigated antibiotic protocols led to comparable microbiological and inflammatory results.",2020,"After 6 months, several periodontopathogens were significantly more reduced in the two antibiotic groups compared to placebo (p < 0.05).","['From the initially treated 102 patients, 75 subjects (Placebo group: n\u2009=\u200926; 3-day']","['3-/7-day systemic antibiotic protocol [amoxicillin (AMX)\u2009+\u2009metronidazole (MET', 'placebo', 'AMX\u2009+\u2009MET group: n\u2009=\u200924; 7-day AMX\u2009+\u2009MET', 'systemic antimicrobials']","['Antibiotic protocols, smoking, disease severity, baseline-BOP, -CAL and -IL-1β, as well as detection of T. denticola', 'reductions and detection of the keystone pathogen P. gingivalis', 'several periodontopathogens']","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1952609', 'cui_str': 'Keystone'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}]",,0.121174,"After 6 months, several periodontopathogens were significantly more reduced in the two antibiotic groups compared to placebo (p < 0.05).","[{'ForeName': 'Raluca', 'Initials': 'R', 'LastName': 'Cosgarea', 'Affiliation': 'Department of Periodontology, Operative and Preventive Dentistry, University of Bonn, Welschnonnen str 17, 53111, Bonn, Germany. ralucacosgarea@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Eick', 'Affiliation': 'Department of Periodontology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jepsen', 'Affiliation': 'Department of Periodontology, Operative and Preventive Dentistry, University of Bonn, Welschnonnen str 17, 53111, Bonn, Germany.'}, {'ForeName': 'N B', 'Initials': 'NB', 'LastName': 'Arweiler', 'Affiliation': 'Department of Periodontology and Peri-implant Diseases, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Juncar', 'Affiliation': 'Department of Dental Medicine, University of Oradea, Oradea, Romania.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Tristiu', 'Affiliation': 'Clinic for Prosthetic Dentistry, University Iuliu-Hatieganu, Cluj-Napoca, Romania.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Salvi', 'Affiliation': 'Department of Periodontology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Heumann', 'Affiliation': 'Department for Statistics, Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sculean', 'Affiliation': 'Department of Periodontology, University of Bern, Bern, Switzerland.'}]",Scientific reports,['10.1038/s41598-020-73054-8']
2983,33007886,A Low FODMAP Diet Is Nutritionally Adequate and Therapeutically Efficacious in Community Dwelling Older Adults with Chronic Diarrhoea.,"The low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP)diet has been extensively researched, but not in the management of older adults with functional gastrointestinal symptoms. This study determines the positive and negative impacts of this dietary treatment in older adults with chronic diarrhea. A non-blinded intervention study was conducted with adults over 65 years with chronic diarrhea referred for colonoscopy where no cause was found. Participants followed a dietitian-led low FODMAP diet for six weeks and completed a structured assessment of gastrointestinal symptoms, the Hospital Anxiety and Depression scale, and a four-day food diary before and after the intervention. Twenty participants, mean age 76 years, were recruited. Adherence to the low FODMAP diet was acceptable; mean daily FODMAP intake reduced from 20.82 g to 3.75 g ( p < 0.001) during the intervention and no clinically significant changes in macro- or micronutrient intakes were observed. There were clinically significant improvements in total gastrointestinal symptoms (pre diet 21.15/88 (standard deviation SD = 10.99), post diet 9.8/88 (SD = 9.58), p < 0.001) including diarrhea (pre diet 9.85 (SD = 3.84), post diet 4.05 (SD = 3.86), p < 0.001) and significant reductions in anxiety (pre diet 6.11/21 (SD = 4.31), post diet 4.26/21 (SD = 3.38), p < 0.05). In older adults the low FODMAP diet is clinically effective and does not jeopardise nutritional intake when supervised by an experienced dietitian.",2020,In older adults the low FODMAP diet is clinically effective and does not jeopardise nutritional intake when supervised by an experienced dietitian.,"['older adults with chronic diarrhea', 'Twenty participants, mean age 76 years, were recruited', 'adults over 65 years with chronic diarrhea referred for colonoscopy where no cause was found', 'Community Dwelling Older Adults with Chronic Diarrhoea', 'older adults with functional gastrointestinal symptoms']","['Low FODMAP Diet', 'dietitian-led low FODMAP diet']","['diarrhea', 'acceptable; mean daily FODMAP intake', 'total gastrointestinal symptoms', 'macro- or micronutrient intakes', 'anxiety']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0401151', 'cui_str': 'Chronic diarrhea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0012611', 'cui_str': 'Disaccharide'}, {'cui': 'C0026492', 'cui_str': 'Monosaccharide'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0861063', 'cui_str': 'Lead low'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0012611', 'cui_str': 'Disaccharide'}, {'cui': 'C0026492', 'cui_str': 'Monosaccharide'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0270022,In older adults the low FODMAP diet is clinically effective and does not jeopardise nutritional intake when supervised by an experienced dietitian.,"[{'ForeName': 'Leigh', 'Initials': 'L', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Skidmore', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wall', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Muir', 'Affiliation': 'Department of Gastroenterology, Central Clinical School, Monash University, Melbourne 3004, VIC, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Frampton', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gearry', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}]",Nutrients,['10.3390/nu12103002']
2984,32986466,Changes in Tendon Elongation and Muscle Atrophy Over Time After Achilles Tendon Rupture Repair: A Prospective Cohort Study on the Effects of Early Functional Mobilization.,"BACKGROUND
Early functional mobilization (EFM) may improve patient outcome after Achilles tendon rupture (ATR). However, whether EFM affects patient outcome via changes in tendon elongation, thickening, or calf muscle atrophy is unknown.
PURPOSE
To analyze differences in tendon and muscle morphology recovery over time between groups treated with EFM or standard treatment after ATR repair.
STUDY DESIGN
Cohort study; Level of evidence, 2.
METHODS
This prospective cohort study included 86 patients (20 women) with ATR repair who had a mean (SD) age of 39.3 (8.2) years and were part of a larger prospective randomized controlled trial. Patients were postoperatively randomized to immediate postoperative weightbearing and ankle motion (EFM group) or to immobilization in a below-knee plaster cast for 2 weeks (control group). Patient-reported and functional outcomes were assessed at 6 and 12 months with the Achilles Tendon Total Rupture Score and the heel-rise test for endurance. At 2 and 6 weeks and 6 and 12 months postoperatively, B-mode ultrasound imaging was performed to assess the length and cross-sectional area (CSA) of the Achilles tendon, the gastrocnemius CSA, as well as the thickness of soleus.
RESULTS
The Achilles Tendon Total Rupture Score for the EFM and control groups were 65.8 (18.7) and 56.8 (20.1; P = .045), respectively, at 6 months and 79.6 (15.8) and 78.9 (17.2; P = .87), respectively, at 12 months. At 2 weeks, tendon elongation was significantly more pronounced in the EFM group as compared with the control group (mean side-to-side difference, 1.88 cm vs 0.71 cm; P = .005). Subsequently, tendon elongation increased in the control group while it decreased in the EFM group so that at 6 and 12 months no significant differences between groups were found. Mean Achilles tendon elongation at 1 year was 1.73 (1.07) cm for the EFM group (n = 55) and 1.67 (0.92) cm for the control group (n = 27), with a mean difference of 0.06 cm (95% CI, 0.54 to -0.42; P = .80). Achilles tendon CSA and calf muscle atrophy displayed no significant differences between the groups; however, significant changes were demonstrated over time ( P ≤ .001) in both groups.
CONCLUSION
EFM results in more Achilles tendon elongation at early healing, but this difference subsides over time. EFM does not seem to affect patient outcome via changes in tendon elongation, thickening, or calf muscle atrophy.
REGISTRATION
NCT02318472 (ClinicalTrials.gov identifier).",2020,"Achilles tendon CSA and calf muscle atrophy displayed no significant differences between the groups; however, significant changes were demonstrated over time ( P ≤ .001) in both groups.
","['or standard treatment after ATR repair', 'After Achilles Tendon Rupture Repair', '86 patients (20 women) with ATR repair who had a mean (SD) age of 39.3 (8.2) years']","['Early functional mobilization (EFM', 'EFM', 'Early Functional Mobilization', 'immediate postoperative weightbearing and ankle motion (EFM group) or to immobilization in a below-knee plaster cast']","['Tendon Elongation and Muscle Atrophy', 'Achilles Tendon Total Rupture Score', 'tendon elongation', 'Mean Achilles tendon elongation', 'Achilles Tendon Total Rupture Score and the heel-rise test for endurance', 'tendon elongation, thickening, or calf muscle atrophy', 'Achilles tendon elongation at early healing', 'Achilles tendon CSA and calf muscle atrophy']","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1318107', 'cui_str': 'Load-Bearing'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0588415', 'cui_str': 'Below knee plaster cast'}]","[{'cui': 'C0856439', 'cui_str': 'Tendon elongation'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",86.0,0.102292,"Achilles tendon CSA and calf muscle atrophy displayed no significant differences between the groups; however, significant changes were demonstrated over time ( P ≤ .001) in both groups.
","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Aufwerber', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Edman', 'Affiliation': 'R&D, Norrtälje Hospital, Tiohundra AB, Norrtälje, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Grävare Silbernagel', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Ackermann', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}]",The American journal of sports medicine,['10.1177/0363546520956677']
2985,32987894,Comprehensive Lifestyle-Modification in Patients with Ulcerative Colitis-A Randomized Controlled Trial.,"Patients with ulcerative colitis suffer from impaired health-related quality of life (HrQoL). Comprehensive lifestyle-modification might increase HrQoL and decrease disease activity. Ninety-seven patients in clinical remission with impaired HrQoL were randomly assigned to a 10 week comprehensive lifestyle-modification program (LSM; n = 47; 50.28 ± 11.90 years) or control ( n = 50; 45.54 ± 12.49 years) that received a single workshop of intense training in naturopathic self-help strategies. Primary outcome was HrQoL (Inflammatory Bowel Disease Questionnaire; IBDQ) at week 12. Secondary outcomes included IBDQ subscales; generic HrQoL; disease activity and microbiome. Both groups showed improvement in HrQoL from baseline to post-treatment at week 12. The IBDQ sum score showed no significant group difference ( p = 0.251). If patients attended more than 50% of the training sessions, a significant group effect ( p = 0.034) was evident in favor of LSM. In addition, the SF-36 mental component summary ( p = 0.002) was significantly different between the groups in favor of LSM. Disease activity microbiome and adverse events did not differ. Both a single workshop and a 10-week comprehensive lifestyle-modification program can improve HrQoL in patients with ulcerative colitis in remission with no apparent effects on clinical disease activity. A treatment difference was observed when examining a subsample of patients who attended ≥ 50% of sessions.",2020,"If patients attended more than 50% of the training sessions, a significant group effect ( p = 0.034) was evident in favor of LSM.","['patients with ulcerative colitis', 'Patients with Ulcerative Colitis', 'Patients with ulcerative colitis suffer from impaired health-related quality of life (HrQoL', 'Ninety-seven patients in clinical remission with impaired HrQoL']","['single workshop of intense training in naturopathic self-help strategies', 'comprehensive lifestyle-modification program', 'Comprehensive Lifestyle-Modification', '10 week comprehensive lifestyle-modification program (LSM']","['HrQoL (Inflammatory Bowel Disease Questionnaire; IBDQ', 'SF-36 mental component summary', 'HrQoL', 'HrQoL and decrease disease activity', 'IBDQ subscales; generic HrQoL; disease activity and microbiome', 'IBDQ sum score', 'Disease activity microbiome and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0684336', 'cui_str': 'Impairment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027495', 'cui_str': 'Naturopathy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.139456,"If patients attended more than 50% of the training sessions, a significant group effect ( p = 0.034) was evident in favor of LSM.","[{'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Langhorst', 'Affiliation': 'Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, Germany, Chair for Integrative Medicine, University of Duisburg-Essen, Buger Straße 80, 96049 Bamberg, Germany.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Schöls', 'Affiliation': 'Integrative Gastroenterology, University of Duisburg-Essen, Evang. Kliniken-Essen-Mitte, Am Deimelsberg 34 a, 45276 Essen, Germany.'}, {'ForeName': 'Zehra', 'Initials': 'Z', 'LastName': 'Cinar', 'Affiliation': 'Integrative Gastroenterology, University of Duisburg-Essen, Evang. Kliniken-Essen-Mitte, Am Deimelsberg 34 a, 45276 Essen, Germany.'}, {'ForeName': 'Ronja', 'Initials': 'R', 'LastName': 'Eilert', 'Affiliation': 'Integrative Gastroenterology, University of Duisburg-Essen, Evang. Kliniken-Essen-Mitte, Am Deimelsberg 34 a, 45276 Essen, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Kofink', 'Affiliation': 'Integrative Gastroenterology, University of Duisburg-Essen, Evang. Kliniken-Essen-Mitte, Am Deimelsberg 34 a, 45276 Essen, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34 a, 45276 Essen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Zempel', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34 a, 45276 Essen, Germany.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Elsenbruch', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, Ruhr University Bochum, Universitätsstraße 150, 44801 Bochum, Germany.'}, {'ForeName': 'Romy', 'Initials': 'R', 'LastName': 'Lauche', 'Affiliation': 'National Centre for Naturopathic Medicine, Southern Cross University, Lismore, Lismore Campus, Military Rd, Lismore, NSW 2480, Australia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'Technical University of Munich, Chair of Nutrition and Immunology, Gregor-Mendel-Str. 2, 85354 Freising-Weihenstephan, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Haller', 'Affiliation': 'Technical University of Munich, Chair of Nutrition and Immunology, Gregor-Mendel-Str. 2, 85354 Freising-Weihenstephan, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Cramer', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34 a, 45276 Essen, Germany.'}, {'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Dobos', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34 a, 45276 Essen, Germany.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Koch', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34 a, 45276 Essen, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9103087']
2986,32987917,Abscisic Acid Treatment in Patients with Prediabetes.,"AIM
to evaluate the effects of abscisic acid (ABA), contained in dwarf peaches, on the regression of impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) conditions.
MATERIALS AND METHODS
sixty-five patients with IFG or IGT were randomized to take ABA or placebo for 3 months. We evaluated: fasting plasma glucose (FPG), postprandial plasma glucose (PPG), glycated hemoglobin (HbA 1c ), fasting plasma insulin (FPI), homeostatic model assessment of insulin resistance (HOMA-IR), lipid profile and high sensitivity C-reactive protein (Hs-CRP). At baseline, and after 3 months, all patients underwent an oral glucose tolerance test (OGTT), an euglycemic hyperinsulinemic clamp, and a glucagon test.
RESULTS
a significant reduction of HbA 1c , FPG, PPG, FPI and HOMA-IR was observed in the ABA group. After 3 months, 26.7% of patients returned to a normal glycemic status in the ABA group versus zero patients in placebo group; 20.0% were classified as IFG and 53.3% as IGT in the nutraceutical group versus 33.3% and 63.3% in the placebo group. The M value was higher in the ABA group at the end of the treatment. Finally, Hs-CRP was reduced after 3 months of ABA consumption.
CONCLUSIONS
abscisic acid can be effective in ameliorating glyco-metabolic compensation and in reducing inflammatory status in patients with IFG or IGT.",2020,"RESULTS
a significant reduction of HbA 1c , FPG, PPG, FPI and HOMA-IR was observed in the ABA group.","['patients with IFG or IGT', 'sixty-five patients with IFG or IGT', 'Patients with Prediabetes']","['abscisic acid', 'Abscisic Acid', 'placebo', 'oral glucose tolerance test (OGTT), an euglycemic hyperinsulinemic clamp, and a glucagon test', 'abscisic acid (ABA', 'ABA or placebo']","['impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) conditions', 'HbA 1c , FPG, PPG, FPI and HOMA-IR', 'M value', 'Hs-CRP', 'fasting plasma glucose (FPG), postprandial plasma glucose (PPG), glycated hemoglobin (HbA 1c ), fasting plasma insulin (FPI), homeostatic model assessment of insulin resistance (HOMA-IR), lipid profile and high sensitivity C-reactive protein (Hs-CRP', 'normal glycemic status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0000843', 'cui_str': 'Abscisic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0337437', 'cui_str': 'Glucagon measurement'}]","[{'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",65.0,0.0269816,"RESULTS
a significant reduction of HbA 1c , FPG, PPG, FPI and HOMA-IR was observed in the ABA group.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Derosa', 'Affiliation': 'Department of Internal Medicine and Therapeutics, IRCCS Policlinico San Matteo Foundation, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Maffioli', 'Affiliation': 'Department of Internal Medicine and Therapeutics, IRCCS Policlinico San Matteo Foundation, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': ""D'Angelo"", 'Affiliation': 'Laboratory of Molecular Medicine, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Paola S', 'Initials': 'PS', 'LastName': 'Preti', 'Affiliation': 'Department of Internal Medicine and Therapeutics, IRCCS Policlinico San Matteo Foundation, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Tenore', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, 80131 Napoli, Italy.'}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'Novellino', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, 80131 Napoli, Italy.'}]",Nutrients,['10.3390/nu12102931']
2987,32987943,Postprandial Effect of Yogurt Enriched with Anthocyanins from Riceberry Rice on Glycemic Response and Antioxidant Capacity in Healthy Adults.,"The pigment of riceberry rice has been reported to contain anthocyanins which act as a free radical scavenger and inhibitor of carbohydrate digestive enzymes. Since the probiotic yogurt incorporated with the pigment of riceberry rice extract was previously developed, the present study was aimed to investigate the acute effect of riceberry rice yogurt consumption on postprandial glycemic response, antioxidant capacity, and subjective ratings in healthy adults. In a cross-over design, 19 healthy participants were randomized to consume 350 g of yogurt supplemented with 0.25% (w/w) riceberry rice extract or the control yogurt. Postprandial plasma glucose, antioxidant status, and subjective ratings were measured at fasting and intervals (0-3 h) after ingestion of yogurt. The primary outcome was glycemic response; the secondary outcomes were plasma antioxidant capacity. In comparison to the yogurt control, riceberry rice yogurt reduced plasma glucose concentration after 30 min of consumption. The incremental area under the curve (iAUC) was significantly lower after riceberry rice yogurt load than after the control yogurt load. The consumption of riceberry yogurt caused an acute increase in plasma ferric reducing ability of plasma (FRAP), Trolox equivalent antioxidant capacity (TEAC), and oxygen radical absorbance capacity (ORAC) from the baseline values after 60 min of 0.25 ± 0.06 mM FeSO 4 , 253.7 ± 35.5 mM Trolox equivalents, and 166.8 ± 28.9 mM Trolox equivalents, respectively. Furthermore, the iAUCs for FRAP, TEAC, ORAC, and protein thiol were higher in riceberry yogurt consumption compared with the control yogurt (1.6-, 1.6-, 2.9-, and 1.9-fold, respectively). A decrease in iAUC for plasma malondialdehyde (MDA) concentration was also observed in the riceberry yogurt group. However, consumption of riceberry rice yogurt and control yogurt showed similar subjective rating scores of hunger, desire to eat, fullness, and satiety. In conclusion, acute consumption of riceberry rice yogurt suppressed postprandial glucose level and improved plasma antioxidant capacity in healthy volunteers.",2020,"The consumption of riceberry yogurt caused an acute increase in plasma ferric reducing ability of plasma (FRAP), Trolox equivalent antioxidant capacity (TEAC), and oxygen radical absorbance capacity (ORAC) from the baseline values after 60 min of 0.25 ± 0.06 mM FeSO 4 , 253.7 ± 35.5 mM Trolox equivalents, and 166.8 ± 28.9 mM Trolox equivalents, respectively.","['Healthy Adults', '19 healthy participants', 'healthy adults', 'healthy volunteers']","['riceberry rice yogurt consumption', 'Anthocyanins from Riceberry Rice', 'consume 350 g of yogurt supplemented with 0.25% (w/w) riceberry rice extract or the control yogurt']","['plasma antioxidant capacity', 'Glycemic Response and Antioxidant Capacity', 'postprandial glycemic response, antioxidant capacity, and subjective ratings', 'incremental area under the curve (iAUC', 'iAUC for plasma malondialdehyde (MDA) concentration', 'plasma glucose concentration', 'plasma ferric reducing ability of plasma (FRAP), Trolox equivalent antioxidant capacity (TEAC), and oxygen radical absorbance capacity (ORAC', 'postprandial glucose level', 'Postprandial plasma glucose, antioxidant status, and subjective ratings', 'subjective rating scores of hunger, desire to eat, fullness, and satiety', 'glycemic response']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C2702414', 'cui_str': 'rice allergenic extract'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0147003', 'cui_str': 'Trolox C'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C4277707', 'cui_str': 'Oxygen Radical Absorbance Capacity'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}]",19.0,0.0414961,"The consumption of riceberry yogurt caused an acute increase in plasma ferric reducing ability of plasma (FRAP), Trolox equivalent antioxidant capacity (TEAC), and oxygen radical absorbance capacity (ORAC) from the baseline values after 60 min of 0.25 ± 0.06 mM FeSO 4 , 253.7 ± 35.5 mM Trolox equivalents, and 166.8 ± 28.9 mM Trolox equivalents, respectively.","[{'ForeName': 'Tanisa', 'Initials': 'T', 'LastName': 'Anuyahong', 'Affiliation': 'Phytochemical and Functional Food Research Unit for Clinical Nutrition, Department of Nutrition and Dietetics, Faculty of Allied Health Science, Chulalongkorn University, Bangkok 10330, Thailand.'}, {'ForeName': 'Charoonsri', 'Initials': 'C', 'LastName': 'Chusak', 'Affiliation': 'Phytochemical and Functional Food Research Unit for Clinical Nutrition, Department of Nutrition and Dietetics, Faculty of Allied Health Science, Chulalongkorn University, Bangkok 10330, Thailand.'}, {'ForeName': 'Thavaree', 'Initials': 'T', 'LastName': 'Thilavech', 'Affiliation': 'Department of Food Chemistry, Faculty of Pharmacy, Mahidol University, Bangkok 10400, Thailand.'}, {'ForeName': 'Sirichai', 'Initials': 'S', 'LastName': 'Adisakwattana', 'Affiliation': 'Phytochemical and Functional Food Research Unit for Clinical Nutrition, Department of Nutrition and Dietetics, Faculty of Allied Health Science, Chulalongkorn University, Bangkok 10330, Thailand.'}]",Nutrients,['10.3390/nu12102930']
2988,32798640,Efficacy of a hospital policy of selective digestive decontamination for carbapenem-resistant Enterobacterales carriers: prospective before-after study.,"A single-centre interrupted time series quasi-experimental study was undertaken to assess whether a hospital policy of selective digestive decontamination (SDD, gentamicin/amikacin with neomycin) administered to carbapenem-resistant Enterobacterales (CRE) carriers would reduce the duration of carriage and contain the spread of CRE. No significant difference in time to CRE eradication was observed between the observation (12 months, 120 patients) and intervention (12 months, 101 patients) periods. No change in the trend of new in-hospital CRE acquisitions or bacteraemia during the intervention was detected. As such, administration of SDD to CRE carriers was not effective for the eradication of carriage or controlling in-hospital CRE transmissions.",2020,"No significant difference in time to CRE eradication was observed between the observation (12 months, 120 patients) and intervention (12 months, 101 patients) periods.",['carbapenem-resistant Enterobacterales carriers'],"['carbapenem-resistant Enterobacterales (CRE', 'selective digestive decontamination (SDD, gentamicin/amikacin with neomycin']","['new in-hospital CRE acquisitions or bacteraemia', 'time to CRE eradication']","[{'cui': 'C0006968', 'cui_str': 'Carbapenem'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}]","[{'cui': 'C0006968', 'cui_str': 'Carbapenem'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0011121', 'cui_str': 'Decontamination'}, {'cui': 'C0074222', 'cui_str': 'SDDS'}, {'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0002499', 'cui_str': 'Amikacin'}, {'cui': 'C0027603', 'cui_str': 'Neomycin'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006968', 'cui_str': 'Carbapenem'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",120.0,0.0211776,"No significant difference in time to CRE eradication was observed between the observation (12 months, 120 patients) and intervention (12 months, 101 patients) periods.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bar-Yoseph', 'Affiliation': 'Department of Gastroenterology, Rambam Health Care Campus, Haifa, Israel; Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel. Electronic address: haggaiby@gmail.com.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lulu', 'Affiliation': 'Department of Internal Medicine H, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shklar', 'Affiliation': 'Division of Infectious Disease, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Korytny', 'Affiliation': 'Department of Gastroenterology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Even Dar', 'Affiliation': 'Department of Internal Medicine H, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Daoud', 'Affiliation': 'Department of Internal Medicine H, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hussein', 'Affiliation': 'Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel; Division of Infectious Disease, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bar-Lavie', 'Affiliation': 'Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel; Intensive Care Unit, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jabareen', 'Affiliation': 'Pharmacy, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Geffen', 'Affiliation': 'Clinical Microbiology Laboratory, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Paul', 'Affiliation': 'Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel; Division of Infectious Disease, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of hospital infection,['10.1016/j.jhin.2020.08.007']
2989,32991582,"The immediate and short-term effects of dynamic taping on pain, endurance, disability, mobility and kinesiophobia in individuals with chronic non-specific low back pain: A randomized controlled trial.","Evidence suggests that the application of Kinesio Tape (KT) on patients with chronic non-specific low back pain (CNLBP) is inconclusive. Dynamic tape (DT) is a relatively new treatment technique, which is increasingly being used as an adjunctive method to treat musculoskeletal problems. To our knowledge, no study has investigated the application of DT in individuals with CNLBP. To compare the immediate and short-term effects of DT versus KT and no tape among patients with CNLBP on pain, endurance, disability, mobility, and kinesiophobia. Forty-five patients with CNLBP were randomly assigned to 1 of 3 groups. Outcomes were measured at baseline, immediately, and on the third day post-application of tapes. The primary outcomes of pain, endurance, and disability were measured through the visual analog scale (VAS), Biering-Sorensen test, and Oswestry disability index (ODI), respectively. Secondary outcome measures of mobility and kinesiophobia were measured using the modified-modified Schober test and the Tampa Scale of Kinesiophobia, respectively. No significant immediate and short-term differences were found between DT and KT in pain, disability, mobility, and kinesiophobia. Improved back extensor endurance was observed for the DT group than KT (p = 0.023) and control group (p = 0.006). The application of DT may result in improvements only in back extensor endurance among individuals with CNLBP. This finding suggests that DT controls the processes that lead to back muscle fatigue.",2020,"No significant immediate and short-term differences were found between DT and KT in pain, disability, mobility, and kinesiophobia.","['patients with CNLBP on', 'Forty-five patients with CNLBP', 'individuals with CNLBP', 'patients with chronic non-specific low back pain (CNLBP', 'individuals with chronic non-specific low back pain']","['Kinesio Tape (KT', 'DT versus KT and no tape', 'dynamic taping', 'Dynamic tape (DT']","['mobility and kinesiophobia', 'Improved back extensor endurance', 'pain, endurance, disability, mobility, and kinesiophobia', 'back extensor endurance', 'pain, endurance, disability, mobility and kinesiophobia', 'DT and KT in pain, disability, mobility, and kinesiophobia', 'pain, endurance, and disability were measured through the visual analog scale (VAS), Biering-Sorensen test, and Oswestry disability index (ODI', 'modified-modified Schober test and the Tampa Scale of Kinesiophobia, respectively']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430750', 'cui_str': 'Modified Schober test'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",45.0,0.0491272,"No significant immediate and short-term differences were found between DT and KT in pain, disability, mobility, and kinesiophobia.","[{'ForeName': 'Khalid A', 'Initials': 'KA', 'LastName': 'Alahmari', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Kanagaraj', 'Initials': 'K', 'LastName': 'Rengaramanujam', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Ravi Shankar', 'Initials': 'RS', 'LastName': 'Reddy', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Paul Silvian', 'Initials': 'PS', 'LastName': 'Samuel', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Jaya Shanker', 'Initials': 'JS', 'LastName': 'Tedla', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Venkata Nagaraj', 'Initials': 'VN', 'LastName': 'Kakaraparthi', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Irshad', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Kingdom of Saudi Arabia.'}]",PloS one,['10.1371/journal.pone.0239505']
2990,32992268,Training with tarantulas: A randomized feasibility and acceptability study using experiential learning to enhance exposure therapy training.,"BACKGROUND
Although exposure is a key evidence-based intervention for anxiety, it is infrequently used in clinical settings. This study employed a novel training strategy, experiential learning, to improve exposure implementation. This study aimed to assess the feasibility and acceptability of experiential training and preliminary training effectiveness.
METHODS
Participants were 28 therapists who were randomized to (a) training-as-usual or (b) experiential training (training-as-usual plus a one-session treatment for fear of spiders). Workshops lasted one day and were followed by three months of weekly consultation.
RESULTS
Experiential training was viewed as feasible and acceptable. Participants, including those who were fearful of spiders, had a positive response to the training and reported it to be useful. There was a significant increase in the number of exposures used by therapists receiving experiential training compared to training-as-usual at 1-month follow-up.
CONCLUSIONS
A one-day training resulted in significant improvements in knowledge, attitudes toward exposure, and self-efficacy in using exposure. Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual. Results provide evidence for the feasibility and acceptability of experiential training as a strategy to increase the use of evidence-based interventions.",2020,Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual.,['Participants were 28 therapists who were randomized to (a'],"['training-as-usual or (b) experiential training (training-as-usual plus a one-session treatment for fear of spiders', 'experiential learning to enhance exposure therapy training', 'experiential training']","['knowledge, attitudes toward exposure, and self-efficacy', 'number of exposures']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia'}, {'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0454267', 'cui_str': 'Number of exposures'}]",28.0,0.02074,Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual.,"[{'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Frank', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA. Electronic address: hannah.frank@temple.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Becker-Haimes', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, 3rd Floor, Philadelphia, PA, 19104, USA; Hall-Mercer Community Mental Health Center, 245 S. 8th St., Philadelphia, PA, 19107, USA.'}, {'ForeName': 'Lara S', 'Initials': 'LS', 'LastName': 'Rifkin', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Norris', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Ollendick', 'Affiliation': 'Child Study Center, Virginia Polytechnic Institute and State University, 460 Turner St., Suite 207, Blacksburg, VA, 24060, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Olino', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Hilary E', 'Initials': 'HE', 'LastName': 'Kratz', 'Affiliation': 'Department of Psychology, La Salle University, 1900 W. Olney Ave., Philadelphia, PA, 19141, USA.'}, {'ForeName': 'Rinad S', 'Initials': 'RS', 'LastName': 'Beidas', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, 3rd Floor, Philadelphia, PA, 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Drive, Philadelphia, PA, 19104, USA; Penn Implementation Science Center at the Leonard David Institute of Health Economics (PISCE @LDI), 3641 Locust Walk, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102308']
2991,32993175,Effects of Psychoactive Massage in Outpatients with Depressive Disorders: A Randomized Controlled Mixed-Methods Study.,"The clinical picture of depressive disorders is characterized by a plethora of somatic symptoms, psychomotor retardation, and, particularly, anhedonia. The number of patients with residual symptoms or treatment resistance is high. Touch is the basic communication among humans and animals. Its application professionally in the form of, e.g., psychoactive massage therapy, has been shown in the past to reduce the somatic and mental symptoms of depression and anxiety. Here, we investigated the effects of a specially developed affect-regulating massage therapy (ARMT) vs. individual treatment with a standardized relaxation procedure, progressive muscle relaxation (PMR), in 57 outpatients with depression. Patients were given one ARMT or PMR session weekly over 4 weeks. Changes in somatic and cognitive symptoms were assessed by standard psychiatric instruments (Hamilton Depression Scale (HAMD) and the Bech-Rafaelsen-Melancholia-Scale (BRMS)) as well as a visual analogue scale. Furthermore, oral statements from all participants were obtained in semi-structured interviews. The findings show clear and statistically significant superiority of ARMT over PMR. The results might be interpreted within various models. The concept of interoception, as well as the principles of body psychotherapy and phenomenological aspects, offers cues for understanding the mechanisms involved. Within a neurobiological context, the significance of C-tactile afferents activated by special touch techniques and humoral changes such as increased oxytocin levels open additional ways of interpreting our findings.",2020,Changes in somatic and cognitive symptoms were assessed by standard psychiatric instruments (Hamilton Depression Scale (HAMD) and the Bech-Rafaelsen-Melancholia-Scale (BRMS)) as well as a visual analogue scale.,"['57 outpatients with depression', 'Outpatients with Depressive Disorders']","['Psychoactive Massage', 'psychoactive massage therapy', 'regulating massage therapy (ARMT) vs. individual treatment with a standardized relaxation procedure, progressive muscle relaxation (PMR', 'ARMT or PMR']","['somatic and cognitive symptoms', 'standard psychiatric instruments (Hamilton Depression Scale (HAMD) and the Bech-Rafaelsen-Melancholia-Scale (BRMS']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}]","[{'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}]","[{'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025193', 'cui_str': 'Melancholia'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]",57.0,0.0157459,Changes in somatic and cognitive symptoms were assessed by standard psychiatric instruments (Hamilton Depression Scale (HAMD) and the Bech-Rafaelsen-Melancholia-Scale (BRMS)) as well as a visual analogue scale.,"[{'ForeName': 'Michaela Maria', 'Initials': 'MM', 'LastName': 'Arnold', 'Affiliation': 'Medizinische Fakultät, Julius-Maximilians-Universität Würzburg, 97070 Würzburg, Germany.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Müller-Oerlinghausen', 'Affiliation': 'Charité, Universitätsmedizin Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Hemrich', 'Affiliation': 'Berufsfachschule für Massage am Universitätsklinikum Würzburg, 97080 Würzburg, Germany.'}, {'ForeName': 'Dominikus', 'Initials': 'D', 'LastName': 'Bönsch', 'Affiliation': 'Medizinische Fakultät, Julius-Maximilians-Universität Würzburg, 97070 Würzburg, Germany.'}]",Brain sciences,['10.3390/brainsci10100676']
2992,32999317,Comparing preference of ankle-foot stiffness in below-knee amputees and prosthetists.,"When fitting prosthetic feet, prosthetists fuse information from their visual assessment of patient gait with the patient's communicated perceptions and preferences. In this study, we sought to simultaneously and independently assess patient and prosthetist preference for prosthetic foot stiffness using a custom variable-stiffness prosthesis. In the first part of the experiment, seven subjects with below-knee amputation walked on the variable-stiffness prosthetic foot set to a randomized stiffness, while several prosthetist subjects simultaneously observed their gait. After each trial, the amputee subjects and prosthetist subjects indicated the change to stiffness that they would prefer (increase or decrease). This paradigm allowed us to simultaneously measure amputee subject and prosthetist subject preferences, and provided a reliability index indicating the consistency of their preferences. In the second part of the experiment, amputee subjects were instructed to communicate verbally with one prosthetist subject to arrive at a mutually preferred stiffness. On average, prosthetist subjects preferred a 26% higher stiffness than amputee subjects (p < 0.001), though this depended on the amputee subject (p < 0.001). Prosthetist subjects were also considerably less consistent than amputee subjects in their preferences (CV of 5.6% for amputee subjects, CV of 23% for prosthetist subjects; p = 0.014). Mutual preference seemed to be dictated by the specific patient-prosthetist dynamic, and no clear trends emerged.",2020,"On average, prosthetist subjects preferred a 26% higher stiffness than amputee subjects (p < 0.001), though this depended on the amputee subject (p < 0.001).",['below-knee amputees and prosthetists'],[],[],"[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0002695', 'cui_str': 'Amputee'}]",[],[],7.0,0.0112582,"On average, prosthetist subjects preferred a 26% higher stiffness than amputee subjects (p < 0.001), though this depended on the amputee subject (p < 0.001).","[{'ForeName': 'Max K', 'Initials': 'MK', 'LastName': 'Shepherd', 'Affiliation': 'Northwestern University Department of Biomedical Engineering, The Center for Bionic Medicine Within the Shirley Ryan AbilityLab, Chicago, IL, USA. maxshep@u.northwestern.edu.'}, {'ForeName': 'Elliott J', 'Initials': 'EJ', 'LastName': 'Rouse', 'Affiliation': 'University of Michigan Neurobionics Lab, Ann Arbor, MI, USA.'}]",Scientific reports,['10.1038/s41598-020-72131-2']
2993,32997684,A Short Message Service (SMS) increases postpartum care-seeking behavior and uptake of family planning of mothers in peri-urban public facilities in Kenya.,"BACKGROUND
It is estimated that one third of maternal deaths in Kenya in 2014 could have been prevented by more timely care-seeking. Mobile health interventions are increasingly being recognized as tools for the delivery of health education and promotion. Many maternal deaths occur in the first few weeks after delivery and mothers who are given adequate care in the postpartum period have better health outcomes. Kiambu County, Kenya has a high level of literacy and phone ownership amongst mothers delivering in public hospitals and was chosen as a site for a postpartum short message service intervention.
METHODS
Women were recruited after delivery and randomized to receive a package of mobile messages or standard of care only. Messages covered danger signs, general postpartum topics, and family planning. Endline phone surveys were conducted at 8 weeks postpartum to assess knowledge, care seeking behavior and family planning uptake. Analysis was conducted using Stata and is presented in odds ratios.
RESULTS
Women who received the danger sign messages were 1.6 times more likely to be able to list at least 1 danger sign and 3.51 times more likely to seek treatment if they experienced postpartum danger signs. There was no significant difference in routine postpartum care seeking or care seeking behaviors concerning newborns. Women who received family planning messages were 1.85 times more likely to uptake family planning services compared to controls and 2.1 times more likely to choose a long-acting method.
CONCLUSIONS
Simple, low-cost mobile interventions can support women in the early postpartum period when the information is targeted to particular points in the postpartum continuum. Additional research is needed to understand the interplay between healthcare providers and mobile health interventions. Health policy makers should consider direct mobile interventions for women as an option for supporting positive maternal health outcomes in certain populations.",2020,"Women who received family planning messages were 1.85 times more likely to uptake family planning services compared to controls and 2.1 times more likely to choose a long-acting method.
","['Women', 'mothers in peri-urban public facilities in Kenya']","['package of mobile messages or standard of care only', 'Short Message Service (SMS']","['uptake family planning services', 'routine postpartum care seeking or care seeking behaviors concerning newborns']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0034018', 'cui_str': 'Public facilities'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]",,0.0717481,"Women who received family planning messages were 1.85 times more likely to uptake family planning services compared to controls and 2.1 times more likely to choose a long-acting method.
","[{'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Jones', 'Affiliation': 'Department of Research & Design, Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kimenju', 'Affiliation': 'Department of Research & Design, Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Subbiah', 'Affiliation': 'Department of Research & Design, Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Styles', 'Affiliation': 'Independent Researcher, Nairobi, Kenya.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Pearson', 'Affiliation': 'Department of Research & Design, Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Sathyanath', 'Initials': 'S', 'LastName': 'Rajasekharan', 'Affiliation': 'Department of Research & Design, Jacaranda Health, Nairobi, Kenya.'}]",PloS one,['10.1371/journal.pone.0239213']
2994,32997710,Cost-effectiveness analysis of two-way texting for post-operative follow-up in Zimbabwe's voluntary medical male circumcision program.,"OBJECTIVE
Although adverse events (AEs) following voluntary medical male circumcision (VMMC) are rare, their prompt ascertainment and management is a marker of quality care. The use of two-way text messaging (2wT) for client follow-up after VMMC reduces the need for clinic visits (standard of care (SoC)) without compromising safety. We compared the cost-effectiveness of 2wT to SoC for post-VMMC follow-up in two, high-volume, public VMMC sites in Zimbabwe.
MATERIALS AND METHODS
We developed a decision-analytic (decision tree) model of post-VMMC client follow-up at two high-volume sites. We parameterized the model using data from both a randomized controlled study of 2wT vs. SoC and from the routine VMMC program. The perspective of analysis was the Zimbabwe government (payer). The time horizon covered the time from VMMC to wound healing. Costs included text messaging; both in-person and outreach follow-up; and AE management. Costs were estimated in 2018 U.S. dollars. The outcome of analysis was AE yield relative to the globally accepted safety standard of a 2% AE rate. We estimated the incremental cost per percentage increase in AE ascertainment and the incremental cost per additional AE identified. We conducted univariate and probabilistic sensitivity analyses.
RESULTS
2wT increased the costs due to text messaging by $4.42 but reduced clinic visit costs by $2.92 and outreach costs by $3.61 -a net savings of $2.10. 2wT also increased AE ascertainment by 50% (92% AE yield in 2wT compared to 42% AE yield in SoC). Therefore, 2wT dominated SoC in the incremental analysis: 2wT was less costly and more effective. Results were generally robust to univariate and probabilistic sensitivity analysis.
CONCLUSIONS
2wT is cost-effective for post-VMMC follow-up in Zimbabwe. Countries in which VMMC is a high-priority HIV prevention intervention should consider this mHealth intervention to reduce overall cost per VMMC, increasing the likelihood of current and future VMMC program sustainability.",2020,"RESULTS
2wT increased the costs due to text messaging by $4.42 but reduced clinic visit costs by $2.92 and outreach costs by $3.61 -a net savings of $2.10.","['voluntary medical male circumcision (VMMC', ""Zimbabwe's voluntary medical male circumcision program""]",[],"['cost-effectiveness', 'costs due to text messaging', 'clinic visit costs', 'AE ascertainment', 'Costs']","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],"[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]",,0.0549168,"RESULTS
2wT increased the costs due to text messaging by $4.42 but reduced clinic visit costs by $2.92 and outreach costs by $3.61 -a net savings of $2.10.","[{'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Babigumira', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barnhart', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Mendelsohn', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Seattle, WA, United States of America.'}, {'ForeName': 'Vernon', 'Initials': 'V', 'LastName': 'Murenje', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.'}, {'ForeName': 'Mufuta', 'Initials': 'M', 'LastName': 'Tshimanga', 'Affiliation': 'Zimbabwe Community Health Intervention Project (ZiCHIRE), Harare, Zimbabwe.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Mauhy', 'Affiliation': 'Zimbabwe Community Health Intervention Project (ZiCHIRE), Harare, Zimbabwe.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Holeman', 'Affiliation': 'Medic Mobile, Nairobi, Kenya.'}, {'ForeName': 'Sinokuthemba', 'Initials': 'S', 'LastName': 'Xaba', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Marrianne M', 'Initials': 'MM', 'LastName': 'Holec', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Seattle, WA, United States of America.'}, {'ForeName': 'Batsirai', 'Initials': 'B', 'LastName': 'Makunike-Chikwinya', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.'}, {'ForeName': 'Caryl', 'Initials': 'C', 'LastName': 'Feldacker', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}]",PloS one,['10.1371/journal.pone.0239915']
2995,33002839,A body-weight-supported visual feedback system for gait recovering in stroke patients: A randomized controlled study.,"OBJECTIVE
The aim of this study was to determine the effectiveness of a novel body-weight-supported (BWS) gait training system with visual feedback, called Copernicus® (Rehalife, Italy). This computerized device provides comfortable, regular and repeatable locomotion in hemiplegic patients. Through visual real-time monitoring of gait parameters, patients are trained to transfer weight loading alternately on both feet.
DESIGN
A single-blind, randomized controlled study. A single center used a computer-generated randomization code to allocate treatments.
SETTING
Intensive rehabilitation unit (IRU) at the Institute S. Anna (Italy).
PARTICIPANTS
63 first-ever stroke patients (39 men, age: 66.1 ± 9.6 years; 61.6 % with left-sided lesion) randomly distributed into three demographically/clinically matched groups.
TREATMENTS
All groups were treated five times a week for 2 -h sessions for six consecutive weeks. The first group (""control"") underwent a conventional physical therapy; the second group performed advanced BWS gait training sessions without visual feedback (Experimental VF- group); whereas the third group used BWS with visual feedback stimulation (Experimental VF+ group).
MAIN OUTCOME MEASURES
Absolute changes were recorded using conventional clinical scales and kinematic measurement of static gait balance from baseline to follow-up.
RESULTS
Significant interaction Group*Time effects scales (F 2,126 = 5.1, p-level = 0.005, η² p = 0.25; F 2,126 = 4.7, p-level = 0.007, η² p = 0.19; respectively) were detected in the Functional Independence Measure and Tinetti-Balance scales. Post hoc analysis demonstrated that the recovery of motor functioning was greater for the VF + group with respect to other groups (all p's ≤ 0.001). A similar pattern of findings was also obtained with a stabilometric analysis, demonstrating a better clinical improvement in static balance after VF + treatment.
CONCLUSION
The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.",2020,The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.,"['hemiplegic patients', 'Intensive rehabilitation unit (IRU) at the Institute S. Anna (Italy', 'gait recovering in stroke patients', '63 first-ever stroke patients (39 men, age: 66.1 ± 9.6 years; 61.6 % with left-sided lesion) randomly distributed into three demographically/clinically matched groups']","['conventional physical therapy; the second group performed advanced BWS gait training sessions without visual feedback (Experimental VF- group); whereas the third group used BWS with visual feedback stimulation (Experimental VF+ group', 'novel body-weight-supported (BWS) gait training system with visual feedback, called Copernicus® (Rehalife, Italy', 'body-weight-supported visual feedback system']","['Group*Time effects scales', 'gait recovery', 'static balance', 'Functional Independence Measure and Tinetti-Balance scales', 'conventional clinical scales and kinematic measurement of static gait balance', 'recovery of motor functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",,0.0295403,The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.,"[{'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Pignolo', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Basta', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Carozzo', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'MariaConcetta', 'Initials': 'M', 'LastName': 'Bilotta', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Todaro', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Serra', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Ciancarelli', 'Affiliation': ""Department of Life, Health and Environmental Sciences, University of L'Aquila, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Tonin', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cerasa', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy; Institute for Biomedical Research and Innovation, National Research Council, (IRIB-CNR), 87050, Mangone, CS, Italy. Electronic address: antonio.cerasa76@gmail.com.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.020']
2996,33003548,The Effects of a 12-Month Weight Loss Intervention on Cognitive Outcomes in Adults with Overweight and Obesity.,"Obesity is associated with poorer executive functioning and reward sensitivity. Yet, we know very little about whether weight loss through diet and/or increased exercise engagement improves cognitive function. This study evaluated whether weight loss following a dietary and exercise intervention was associated with improved cognitive performance. We enrolled 125 middle-aged adults with overweight and obesity (98 female) into a 12-month behavioral weight loss intervention. Participants were assigned to one of three groups: energy-restricted diet alone, an energy-restricted diet plus 150 min of moderate intensity exercise per week or an energy restricted diet plus 250 min of exercise per week. All participants completed tests measuring executive functioning and/or reward sensitivity, including the Iowa Gambling Task (IGT). Following the intervention, weight significantly decreased in all groups. A MANCOVA controlling for age, sex and race revealed a significant multivariate effect of group on cognitive changes. Post-hoc ANCOVAs revealed a Group x Time interaction only on IGT reward sensitivity, such that the high exercise group improved their performance relative to the other two intervention groups. Post-hoc ANCOVAs also revealed a main effect of Time, independent of intervention group, on IGT net payoff score. Changes in weight were not associated with other changes in cognitive performance. Engaging in a high amount of exercise improved reward sensitivity above and beyond weight loss alone. This suggests that there is additional benefit to adding exercise into behavioral weight loss regimens on executive functioning, even without additional benefit to weight loss.",2020,"Post-hoc ANCOVAs also revealed a main effect of Time, independent of intervention group, on IGT net payoff score.","['125 middle-aged adults with overweight and obesity (98 female) into a 12-month behavioral weight loss intervention', 'Adults with Overweight and Obesity']","['energy-restricted diet alone, an energy-restricted diet plus 150 min of moderate intensity exercise per week or an energy restricted diet plus 250 min of exercise per week', 'dietary and exercise intervention', 'Weight Loss Intervention']","['cognitive performance', 'weight loss', 'weight', 'executive functioning and/or reward sensitivity, including the Iowa Gambling Task (IGT', 'IGT net payoff score', 'Cognitive Outcomes', 'reward sensitivity above and beyond weight loss alone']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",125.0,0.0173392,"Post-hoc ANCOVAs also revealed a main effect of Time, independent of intervention group, on IGT net payoff score.","[{'ForeName': 'Jamie C', 'Initials': 'JC', 'LastName': 'Peven', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Healthy Lifestyle Institute, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Renee J', 'Initials': 'RJ', 'LastName': 'Rogers', 'Affiliation': 'Healthy Lifestyle Institute, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Lesnovskaya', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Kirk I', 'Initials': 'KI', 'LastName': 'Erickson', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Chaeryon', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Xueping', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Porter', 'Affiliation': 'Department of Psychology, Carnegie Mellon University, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Shannon D', 'Initials': 'SD', 'LastName': 'Donofry', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Watt', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Chelsea M', 'Initials': 'CM', 'LastName': 'Stillman', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}]",Nutrients,['10.3390/nu12102988']
2997,33006562,An Interactive Text Messaging Intervention to Improve Adherence to Option B+ Prevention of Mother-to-Child HIV Transmission in Kenya: Cost Analysis.,"BACKGROUND
Mobile health (mHealth) approaches offer potentially affordable ways to support the care of HIV-infected patients in overstretched health care systems. However, only few studies have analyzed the costs associated with mHealth solutions for HIV care.
OBJECTIVE
The aim of this study was to estimate the total incremental costs and incremental cost per beneficiary of an interactive SMS text messaging support intervention within a clinical trial.
METHODS
The Mobile WAChX trial (NCT02400671) evaluates an interactive semiautomated SMS text messaging intervention to improve adherence to antiretroviral therapy and retention in care among peripartum women infected with HIV in Kenya to reduce the mother-to-child transmission of HIV. Women were randomized to receive one-way versus two-way SMS text messages. Messages were sent weekly, and these messages included motivational and educational content and visit reminders; two-way messaging enabled prompt consultation with the nurse as needed. Microcosting methods were used to collect resource-use data related to implementing the Mobile WAChX SMS text messaging intervention. At 2 sites (Nairobi and Western Kenya), we conducted semistructured interviews with health personnel to identify startup and recurrent activities by obtaining information on the personnel, supplies, and equipment. Data on expenditures and prices from project expense reports, administrative records, and published government salary data were included to estimate the total incremental costs. Using a public provider perspective, we estimated incremental unit costs per beneficiary and per contact during 2017.
RESULTS
The weighted average annual incremental costs for the two-way SMS text messaging group were US $3725 per facility, US $62 per beneficiary, and US $0.85 per contact to reach 115 beneficiaries. For the one-way SMS text messaging group, the weighted average annual incremental costs were US $2542 per facility, US $41 per beneficiary, and US $0.66 per contact to reach 117 beneficiaries. The largest cost shares were for the personnel: 48.2% (US $1794/US $3725) in two-way and 32.4% (US $825/US $2542) in one-way SMS text messaging groups. Costs associated with software development and communication accounted for 29.9% (US $1872/US $6267) of the costs in both intervention arms (US $1042 vs US $830, respectively).
CONCLUSIONS
Cost information for budgeting and financial planning is relevant for implementing mHealth interventions in national health plans. Given the proportion of costs related to systems development, it is likely that costs per beneficiary will decline with the scale-up of the interventions.",2020,The largest cost shares were for the personnel: 48.2% (US $1794/US $3725) in two-way and 32.4% (US $825/US $2542) in one-way SMS text messaging groups.,"['Mother-to-Child HIV Transmission in Kenya', 'peripartum women infected with HIV in Kenya to reduce the mother-to-child transmission of HIV']","['interactive semiautomated SMS text messaging intervention', 'Interactive Text Messaging Intervention', 'interactive SMS text messaging support intervention']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C2936492', 'cui_str': 'Peripartum Women'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",[],,0.0560755,The largest cost shares were for the personnel: 48.2% (US $1794/US $3725) in two-way and 32.4% (US $825/US $2542) in one-way SMS text messaging groups.,"[{'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Keshet', 'Initials': 'K', 'LastName': 'Ronen', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Matemo', 'Affiliation': 'Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Unger', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinuthia', 'Affiliation': 'Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'John-Stewart', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levin', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}]",JMIR mHealth and uHealth,['10.2196/18351']
2998,33006564,User Experiences of a Smartphone-Based Attentive Eating App and Their Association With Diet and Weight Loss Outcomes: Thematic and Exploratory Analyses From a Randomized Controlled Trial.,"BACKGROUND
Short-term laboratory studies suggest that eating attentively can reduce food intake. However, in a recent randomized controlled trial we found no evidence that using an attentive eating smartphone app outside of the laboratory had an effect on energy intake or weight loss over 8 weeks.
OBJECTIVE
This research examined trial participants' experiences of using an attentive eating smartphone app and whether app usage was associated with energy intake and weight loss outcomes over 8 weeks.
METHODS
We conducted thematic analysis of semistructured interviews (N=38) among participants in the attentive eating smartphone app group of the trial who completed the 8-week assessment. Linear regression models examined the associations between energy intake and weight loss outcomes at 8 weeks and app usage.
RESULTS
Participants reported several barriers and facilitators to using the smartphone app, including repetition of app content, social setting, motivation, and habitual use of the app. Participants believed that using the app had some beneficial effects on their eating behavior and diet. Exploratory analyses indicated that more frequent recording of eating episodes in the app was associated with lower body weight (B=-0.02, P=.004) and greater self-reported energy intake (B=5.98, P=.01) at 8 weeks, but not body fat percentage or taste-test energy intake. Total audio clip plays, gallery views, and percentage of food entries recorded using an image were not significantly associated with energy intake or weight.
CONCLUSIONS
Frequent recording of eating episodes in a smartphone app was associated with greater weight loss. There are barriers and facilitators to frequent use of an attentive eating smartphone app that may be useful to address when designing dietary behavior change smartphone apps.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03602001; https://clinicaltrials.gov/ct2/show/NCT03602001; Open Science Framework DOI 10.17605/osf.io/btzhw; https://osf.io/btzhw/.",2020,"Total audio clip plays, gallery views, and percentage of food entries recorded using an image were not significantly associated with energy intake or weight.
",['semistructured interviews (N=38) among participants in the attentive eating smartphone app group of the trial who completed the 8-week assessment'],['Smartphone-Based Attentive Eating App and Their Association With Diet and Weight'],"['energy intake or weight loss', 'weight loss', 'Total audio clip plays, gallery views, and percentage of food entries', 'lower body weight', 'greater self-reported energy intake', 'repetition of app content, social setting, motivation, and habitual use of the app', 'frequent recording of eating episodes']","[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",,0.127886,"Total audio clip plays, gallery views, and percentage of food entries recorded using an image were not significantly associated with energy intake or weight.
","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Whitelock', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Kersbergen', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Higgs', 'Affiliation': 'The School of Psychology, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Services, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jason Cg', 'Initials': 'JC', 'LastName': 'Halford', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/16780']
2999,33006567,Predictors and Effects of Usage of an Online Mindfulness Intervention for Distressed Cancer Patients: Usability Study.,"BACKGROUND
One in three cancer patients experience high psychological distress. Mindfulness-based interventions are effective in reducing psychological distress in this patient group. However, these interventions lack availability and flexibility, which may compromise participation in the intervention for cancer patients experiencing late symptoms like fatigue or pain. Therefore, mindfulness-based interventions are increasingly offered via the internet. However, little is known about the usage of these online mindfulness-based interventions.
OBJECTIVE
The aim of this study was to (1) predict uptake of and adherence to online mindfulness-based cognitive therapy (eMBCT) using baseline patient characteristics (demographic, cancer-related, personality, and psychological variables) and (2) examine the relations between adherence and treatment outcomes in eMBCT for cancer patients.
METHODS
A total of 125 cancer patients were assigned to eMBCT in a parent randomized controlled trial comparing MBCT and eMBCT with treatment as usual in distressed cancer patients. Various usage measures of eMBCT were automatically tracked within the online program. Based on activity of use, participants were classified as nonusers, minimal users, low users, and intended users. Questionnaires were used to assess baseline characteristics (preintervention) and outcomes (pre- and postintervention). To answer the research questions, data were analyzed with t tests, χ 2 tests, and linear regression models.
RESULTS
Based on weekly activity, participants were classified as nonusers (n=17, 13.6%), who completed no exercises in MBCT; minimal users (n=31, 24.8%), who completed at least one exercise of one to three sessions; low users (n=12, 9.6%), who completed at least one exercise of four to seven sessions; and intended users (n=65, 52.0%), who completed at least one exercise of eight to nine sessions. Nonusers had more fear of cancer recurrence at baseline than users (uptake), and intended users were more conscientious than minimal and low users (adherence). Intended users reported a larger reduction in psychological distress and more improvement of positive mental health (ie, emotional, psychological, and social well-being) after the intervention than other participants.
CONCLUSIONS
This study showed that adherence was related to improved patient outcomes. Patients with strong fear of recurrence or low levels of conscientiousness should receive extra attention, as they are less likely to respectively start or complete eMBCT. Future research may focus on the development of flexible and adaptive eMBCT programs to fit individual needs.",2020,"Intended users reported a larger reduction in psychological distress and more improvement of positive mental health (ie, emotional, psychological, and social well-being) after the intervention than other participants.
","['distressed cancer patients', 'Patients with strong fear of recurrence or low levels of conscientiousness', '125 cancer patients', 'cancer patients experiencing late symptoms like fatigue or pain', 'cancer patients', 'Distressed Cancer Patients', 'participants were classified as nonusers (n=17, 13.6%), who completed no exercises in MBCT; minimal users (n=31, 24.8%), who completed at least one exercise of one to three sessions; low users (n=12, 9.6%), who completed at least one exercise of four to seven sessions; and intended users (n=65, 52.0%), who completed at least one exercise of eight to nine sessions', 'participants were classified as nonusers, minimal users, low users, and intended users', 'three cancer patients experience high psychological distress']","['online mindfulness-based cognitive therapy (eMBCT', 'eMBCT', 'Mindfulness-based interventions', 'Online Mindfulness Intervention', 'MBCT and eMBCT']","['psychological distress', 'fear of cancer recurrence', 'positive mental health (ie, emotional, psychological, and social well-being']","[{'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",125.0,0.0800104,"Intended users reported a larger reduction in psychological distress and more improvement of positive mental health (ie, emotional, psychological, and social well-being) after the intervention than other participants.
","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cillessen', 'Affiliation': 'Department of Psychiatry, Center for Mindfulness, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Monique Om', 'Initials': 'MO', 'LastName': 'van de Ven', 'Affiliation': 'Department of Medical Psychology, Laurentius Hospital, Roermond, Netherlands.'}, {'ForeName': 'Félix R', 'Initials': 'FR', 'LastName': 'Compen', 'Affiliation': 'Department of Psychiatry, Center for Mindfulness, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Else M', 'Initials': 'EM', 'LastName': 'Bisseling', 'Affiliation': 'Department of Psychiatry, Center for Mindfulness, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Marije L', 'Initials': 'ML', 'LastName': 'van der Lee', 'Affiliation': 'Scientific Research Department, Centre for Psycho-Oncology, Helen Dowling Institute, Bilthoven, Netherlands.'}, {'ForeName': 'Anne Em', 'Initials': 'AE', 'LastName': 'Speckens', 'Affiliation': 'Department of Psychiatry, Center for Mindfulness, Radboud University Medical Center, Nijmegen, Netherlands.'}]",Journal of medical Internet research,['10.2196/17526']
3000,33006569,Evaluating the Efficacy of a Mobile App (Drinks:Ration) and Personalized Text and Push Messaging to Reduce Alcohol Consumption in a Veteran Population: Protocol for a Randomized Controlled Trial.,"BACKGROUND
Alcohol misuse is higher in the UK Armed Forces than in the general population. Previous research has shown that interventions delivered via smartphones are efficacious in promoting self-monitoring of alcohol use, have utility in reducing alcohol consumption, and have a broad reach.
OBJECTIVE
This single-blinded randomized controlled trial (RCT) aims to assess the efficacy of a 28-day brief alcohol intervention delivered via a smartphone app (Drinks:Ration) in reducing weekly self-reported alcohol consumption between baseline and 3-month follow-up among veterans who drink at a hazardous or harmful level and receive or have received support for mental health symptoms in a clinical setting.
METHODS
In this two-arm, single-blinded RCT, a smartphone app that includes interactive features designed to enhance participants' motivation and personalized messaging is compared with a smartphone app that provides only government guidance on alcohol consumption. The trial will be conducted in a veteran population that has sought help through Combat Stress, a UK veteran's mental health charity. Recruitment, consent, and data collection will be carried out automatically through the Drinks:Ration platform. The primary outcome is the change in self-reported weekly alcohol consumption between baseline (day 0) and 3-month follow-up (day 84) as measured using the Time-Line Follow back for Alcohol Consumption. Secondary outcome measures include (1) change in the baseline to 3-month follow-up (day 84) Alcohol Use Disorder Identification Test score and (2) change in the baseline to 3-month follow-up (day 84) World Health Organization Quality of Life-BREF score to assess the quality of adjusted life years. Process evaluation measures include (1) app use and (2) usability ratings as measured by the mHealth App Usability Questionnaire. The primary and secondary outcomes will also be reassessed at the 6-month follow-up (day 168) to assess the longer-term benefits of the intervention, which will be reported as a secondary outcome.
RESULTS
The study will begin recruitment in October 2020 and is expected to require 12 months to complete. The study results will be published in 2022.
CONCLUSIONS
This study assesses whether a smartphone app is efficacious in reducing self-reported alcohol consumption in a veteran population that has sought help through Combat Stress using personalized messaging and interactive features. This innovative approach, if successful, may provide a means to deliver a low-cost health promotion program that has the potential to reach large groups, in particular those who are geographically dispersed, such as military personnel.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04494594; https://clinicaltrials.gov/ct2/show/NCT04494594.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
PRR1-10.2196/19720.",2020,"Previous research has shown that interventions delivered via smartphones are efficacious in promoting self-monitoring of alcohol use, have utility in reducing alcohol consumption, and have a broad reach.
",['veterans who drink at a hazardous or harmful level and receive or have received support for mental health symptoms in a clinical setting'],"['alcohol intervention delivered via a smartphone app (Drinks:Ration', 'Mobile App (Drinks:Ration) and Personalized Text and Push Messaging', 'smartphone']","['change in self-reported weekly alcohol consumption between baseline (day 0) and 3-month follow-up (day 84) as measured using the Time-Line Follow back for Alcohol Consumption', 'Process evaluation measures include (1) app use and (2) usability ratings as measured by the mHealth App Usability Questionnaire', 'World Health Organization Quality of Life-BREF score', '1) change in the baseline to 3-month follow-up (day 84']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0580841', 'cui_str': 'Does push'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451543', 'cui_str': 'Time line follow back'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.170033,"Previous research has shown that interventions delivered via smartphones are efficacious in promoting self-monitoring of alcohol use, have utility in reducing alcohol consumption, and have a broad reach.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Leightley', 'Affiliation': ""King's College London, King's Centre for Military Health Research, London, United Kingdom.""}, {'ForeName': 'Roberto J', 'Initials': 'RJ', 'LastName': 'Rona', 'Affiliation': ""King's College London, King's Centre for Military Health Research, London, United Kingdom.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shearer', 'Affiliation': ""King's College London, King's Health Economics, London, United Kingdom.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Williamson', 'Affiliation': 'Combat Stress, Leatherhead, United Kingdom.'}, {'ForeName': 'Cerisse', 'Initials': 'C', 'LastName': 'Gunasinghe', 'Affiliation': ""King's College London, Department of Psychological Medicine, London, United Kingdom.""}, {'ForeName': 'Amos', 'Initials': 'A', 'LastName': 'Simms', 'Affiliation': ""Academic Department of Military Mental Health, King's College London, London, United Kingdom.""}, {'ForeName': 'Nicola T', 'Initials': 'NT', 'LastName': 'Fear', 'Affiliation': ""King's College London, King's Centre for Military Health Research, London, United Kingdom.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Goodwin', 'Affiliation': 'University of Liverpool, Department of Psychological Sciences, Liverpool, United Kingdom.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Murphy', 'Affiliation': ""King's College London, King's Centre for Military Health Research, London, United Kingdom.""}]",JMIR research protocols,['10.2196/19720']
3001,33010058,Pharmacological data of a successful 4-days-a-week regimen in HIV antiretroviral therapy (ANRS 162-4D trial).,"INTRODUCTION
Few data are available on plasma concentrations of antiretroviral therapy (ARV) during intermittent treatment.
OBJECTIVE
To compare plasma concentrations in OFF vs ON treatment periods at several time points during treatment.
METHODS
During a successful 48-week multicenter study (ANRS 162-4D trial) of 4 days with treatment (ON) followed by 3 days without treatment (OFF) in adults treated by two nucleoside analogues and a third agent belonging to a boosted protease-inhibitor (PI, darunavir [DRV], atazanavir [ATV], lopinavir [LPV]) or a non-nucleoside-reverse-transcriptase inhibitor (NNRTI, efavirenz [EFV], etravirine [ETR], rilpivirine [RPV]) conducted in 100 patients (96% success), we determined the plasma concentrations of ARV. Blood samples were collected for analysis at inclusion (W0, 7/7 strategy for all patients), W16 and W40 (ON) and at W4, W8, W12, W24, W32 and W48 (OFF).
RESULTS
A total of 866 samples was analysed. Plasma concentrations were not statistically lower after 4 days (ON) vs 7/7 days of treatment except for RPV (-30 ng/mL at 4/7, P = 0.003). Significant lower plasma concentrations were observed for OFF vs ON except for ETR (n = 5, P = 0.062). Overall, 87.1% of ON concentrations (ATV 92.1%, DRV 51.1%, LPV 62.5%, EFV 94.4%, ETR 100% and RPV 94.9%) and 21.8% of OFF concentrations (ATV 1.4%, DRV 0.0%, LPV 0.0%, EFV 16.0%, ETR 92.6% and RPV 39.0%) were above the theoretical limit of efficacy of the molecule. In the OFF period, 85.8% of PI concentrations were under the limit of quantification, while 98.0% of NNRTI concentrations were quantifiable.
CONCLUSION
Despite low/undetectable PI/NNRTI plasma concentrations in the OFF period, patients maintained an undetectable viral load. The mechanistic explanation should be investigated.",2020,"Plasma concentrations were not statistically lower after 4 days (ON) vs 7/7 days of treatment except for RPV (-30 ng/mL at 4/7, P=0.003).",[],"['2 nucleosides analogs and a third agent belonging to boosted protease-inhibitor (PI, Darunavir-DRV, Atazanavir-ATV, Lopinavir-LPV) or a non-nucleoside-reverse-transcriptase inhibitor (NNRTI, Efavirenz-EFV, Etravirine-ETR, Rilpivirine-RPV']","['plasma concentrations', 'Blood samples', 'plasma concentrations of ARV', 'Plasma concentrations', 'OFF concentrations']",[],"[{'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0210243', 'cui_str': 'atevirdine'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C3541376', 'cui_str': 'Non-nucleoside reverse transcriptase inhibitors'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1456409', 'cui_str': 'etravirine'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",866.0,0.0691798,"Plasma concentrations were not statistically lower after 4 days (ON) vs 7/7 days of treatment except for RPV (-30 ng/mL at 4/7, P=0.003).","[{'ForeName': 'Emuri', 'Initials': 'E', 'LastName': 'Abe', 'Affiliation': 'Département de Pharmacologie-Toxicologie, Hôpitaux Universitaires Paris-Ile de France-Ouest, APHP, Hôpital Raymond Poincaré, MasSpecLab, Plateforme de spectrométrie de masse, Inserm U-1173, Université Versailles Saint Quentin-en-Yvelines, Garches, France.'}, {'ForeName': 'Lambert', 'Initials': 'L', 'LastName': 'Assoumou', 'Affiliation': ""Institut Pierre Louis d'Épidémiologie et de Santé Publique, Sorbonne Université, INSERM, Paris, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'de Truchis', 'Affiliation': ""Département d'Infectiologie, Hôpitaux Universitaires Paris-Ile de France-Ouest, APHP, Hôpital Raymond Poincaré Garches, Garches, France.""}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Amat', 'Affiliation': 'Institut de Médecine et Epidémiologie Appliquée, Hôpital Bichat-Claude Bernard, Université Paris 7, Paris, France.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Gibowski', 'Affiliation': 'ANRS, France Recherche Nord & Sud SIDA-HIV hépatites, Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Gras', 'Affiliation': 'Centre Hospitalier Universitaire Bretonneau, Tours, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Bellet', 'Affiliation': ""Institut Pierre Louis d'Épidémiologie et de Santé Publique, Sorbonne Université, INSERM, Paris, France.""}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Saillard', 'Affiliation': 'ANRS, France Recherche Nord & Sud SIDA-HIV hépatites, Paris, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Katlama', 'Affiliation': ""Institut Pierre Louis d'Épidémiologie et de Santé Publique, Sorbonne Université, INSERM, Paris, France.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Costagliola', 'Affiliation': ""Institut Pierre Louis d'Épidémiologie et de Santé Publique, Sorbonne Université, INSERM, Paris, France.""}, {'ForeName': 'Pierre-Marie', 'Initials': 'PM', 'LastName': 'Girard', 'Affiliation': ""Institut Pierre Louis d'Épidémiologie et de Santé Publique, Sorbonne Université, INSERM, Paris, France.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Landman', 'Affiliation': 'Institut de Médecine et Epidémiologie Appliquée, Hôpital Bichat-Claude Bernard, Université Paris 7, Paris, France.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Alvarez', 'Affiliation': 'Département de Pharmacologie-Toxicologie, Hôpitaux Universitaires Paris-Ile de France-Ouest, APHP, Hôpital Raymond Poincaré, MasSpecLab, Plateforme de spectrométrie de masse, Inserm U-1173, Université Versailles Saint Quentin-en-Yvelines, Garches, France.'}]",British journal of clinical pharmacology,['10.1111/bcp.14586']
3002,33010371,Randomized trial of the i-gel supraglottic airway device versus tracheal intubation during out of hospital cardiac arrest (AIRWAYS-2): Patient outcomes at three and six months.,"AIM
The AIRWAYS-2 cluster randomised controlled trial compared the i-gel supraglottic airway device (SGA) with tracheal intubation (TI) as the first advanced airway management (AAM) strategy used by Emergency Medical Service clinicians (paramedics) treating adult patients with non-traumatic out-of-hospital cardiac arrest (OHCA). It showed no difference between the two groups in the primary outcome of modified Rankin Scale (mRS) score at 30 days/hospital discharge. This paper reports outcomes to 6 months.
METHODS
Paramedics from four ambulance services in England were randomised 1:1 to use an i-gel SGA (759 paramedics) or TI (764 paramedics) as their initial approach to AAM. Adults who had a non-traumatic OHCA and were attended by a participating paramedic were enrolled automatically under a waiver of consent. Survivors were invited to complete questionnaires at three and six months after OHCA. Outcomes were analysed using regression methods.
RESULTS
767/9296 (8.3%) enrolled patients survived to 30 days/hospital discharge and 317/767 survivors (41.3%) consented and were followed-up to six months. No significant differences were found between the two treatment groups in the primary outcome measure (mRS score: 3 months: odds ratio (OR) for good recovery (i-gel/TI, OR) 0.89, 95% CI 0.69-1.14; 6 months OR 0.91, 95% CI 0.71-1.16). EQ-5D-5L scores were also similar between groups and sensitivity analyses did not alter the findings.
CONCLUSION
There were no statistically significant differences between the TI and i-gel groups at three and six months. We therefore conclude that the initially reported finding of no significant difference between groups at 30 days/hospital discharge was sustained when the period of follow-up was extended to six months.",2020,"No significant differences were found between the two treatment groups in the primary outcome measure (mRS score: 3 months: odds ratio (OR) for good recovery (i-gel/TI, OR) 0.89, 95% CI 0.69-1.14; 6 months OR 0.91, 95% CI 0.71-1.16).","['Paramedics from four ambulance services in England', 'Adults who had a non-traumatic OHCA and were attended by a participating paramedic were enrolled automatically under a waiver of consent', 'Emergency Medical Service clinicians (paramedics) treating adult patients with non-traumatic out-of-hospital cardiac arrest (OHCA', '767/9296 (8.3%) enrolled patients survived to 30 days/hospital discharge and 317/767 survivors (41.3%) consented and were followed-up to six months']","['gel supraglottic airway device (SGA) with tracheal intubation (TI', 'i-gel Supraglottic Airway Device Versus Tracheal Intubation', 'i-gel SGA']","['hospital discharge', 'modified Rankin Scale (mRS) score', 'primary outcome measure (mRS score: 3 months: odds ratio (OR) for good recovery', 'EQ-5D-5L scores']","[{'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4517770', 'cui_str': '41.3'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",,0.103585,"No significant differences were found between the two treatment groups in the primary outcome measure (mRS score: 3 months: odds ratio (OR) for good recovery (i-gel/TI, OR) 0.89, 95% CI 0.69-1.14; 6 months OR 0.91, 95% CI 0.71-1.16).","[{'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Benger', 'Affiliation': 'University of the West of England, Glenside Campus, Bristol, UK. Electronic address: Jonathan.Benger@uwe.ac.uk.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Lazaroo', 'Affiliation': 'Clinical Trials and Evaluation Unit (CTEU), Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Clout', 'Affiliation': 'Clinical Trials and Evaluation Unit (CTEU), Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Voss', 'Affiliation': 'University of the West of England, Glenside Campus, Bristol, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Black', 'Affiliation': 'South Western Ambulance Service NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Brett', 'Affiliation': 'Department of Surgery and Cancer, Imperial College, London, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Kirby', 'Affiliation': 'University of the West of England, Glenside Campus, Bristol, UK; South Western Ambulance Service NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Nolan', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK; Department of Anaesthesia, Royal United Hospital, Bath, UK.'}, {'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit (CTEU), Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'South Western Ambulance Service NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Scott', 'Affiliation': 'Clinical Trials and Evaluation Unit (CTEU), Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK; National Institute for Health Research Applied Research Collaboration West (NIHR ARC West), University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Smartt', 'Affiliation': 'Clinical Trials and Evaluation Unit (CTEU), Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'South', 'Affiliation': 'South Western Ambulance Service NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Clinical Trials and Evaluation Unit (CTEU), Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK; Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Intensive Care Unit, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wordsworth', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit (CTEU), Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}]",Resuscitation,['10.1016/j.resuscitation.2020.09.026']
3003,33010470,Effectiveness of Modalities to Teach Evidence Based Medicine to Pediatric Clerkship Students: A Randomized Controlled Trial.,"OBJECTIVE
To evaluate the effectiveness of a traditional didactic session (TDS) as compared to a self-paced, interactive, multimedia module (SPM) on the application of evidence-based medicine (EBM) skills among medical students during their inpatient pediatric rotation.
METHODS
We conducted a randomized controlled trial from June, 2017 to June, 2018 at a quaternary care children's hospital. Students were randomized to TDS or SPM during each 2-week block. All students completed a critical appraisal tool (CAT) of evidence related to a clinical question in a standardized appraisal form and self-reflected about the EBM process. The primary outcome was the numeric score of the CAT derived by using the validated Fresno tool. Secondary outcomes of knowledge, attitudes, confidence, and self-reported behaviors related to EBM were measured using validated surveys. Statistical analysis was performed using Student's t test for CAT scores and mixed-model procedure (PROC MIXED), with subject as random effect and time as repeated measure for the secondary outcomes.
RESULTS
One hundred twenty-seven clerkship students were included. Overall, there was no significant difference in mean CAT scores for TDS (n = 59) versus SPM (n = 66) groups (90.3 vs 92.0, P = .65). There were no significant differences between SPM and TDS groups for knowledge (P = .66), attitudes (P = .97), confidence (P = .55), and accessing evidence (P = .27). Both groups showed significant gains in knowledge, attitudes, confidence, and accessing evidence from baseline to postcourse. Improvements in knowledge and confidence were sustained at 3-months.
CONCLUSION
A SPM learning module is as effective as a TDS module for application of EBM concepts and knowledge to patient care.",2020,A SPM learning module is as effective as a TDS module for application of EBM concepts and knowledge to patient care.,"['Pediatric Clerkship Students', ""6/2017 to 6/2018 at a quaternary care children's hospital"", 'medical students during their inpatient pediatric rotation', '127 clerkship students']","['SPM', 'traditional didactic session (TDS', 'TDS', 'self-paced, interactive, multimedia module (SPM', 'TDS or SPM']","['knowledge, attitudes, confidence, and accessing evidence', 'knowledge, attitudes, confidence, and self-reported behaviors related to EBM', 'mean CAT scores', 'numeric score of the CAT']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376537', 'cui_str': 'Medicine, Evidence-Based'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.166549,A SPM learning module is as effective as a TDS module for application of EBM concepts and knowledge to patient care.,"[{'ForeName': 'Teena', 'Initials': 'T', 'LastName': 'Hadvani', 'Affiliation': 'Department of Pediatrics (T Hadvani, E Choy, C Molleda, V Parikh, MA Lopez, K Lui, K Ban, and SS Wallace), Section of Pediatric Hospital Medicine, Baylor College of Medicine, Houston, Tex. Electronic address: tshadvan@texaschildrens.org.'}, {'ForeName': 'Ankhi', 'Initials': 'A', 'LastName': 'Dutta', 'Affiliation': 'Department of Pediatrics (A Dutta), Section of Pediatric Infectious Diseases, Baylor College of Medicine, The Woodlands, Tex.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Choy', 'Affiliation': 'Department of Pediatrics (T Hadvani, E Choy, C Molleda, V Parikh, MA Lopez, K Lui, K Ban, and SS Wallace), Section of Pediatric Hospital Medicine, Baylor College of Medicine, Houston, Tex.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Department of Pediatrics (S Kumar), Center of Research, Innovation, and Scholarship for Medical Education, Baylor College of Medicine/Texas Children's Hospital, Houston, Tex.""}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Molleda', 'Affiliation': 'Department of Pediatrics (T Hadvani, E Choy, C Molleda, V Parikh, MA Lopez, K Lui, K Ban, and SS Wallace), Section of Pediatric Hospital Medicine, Baylor College of Medicine, Houston, Tex.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Parikh', 'Affiliation': 'Department of Pediatrics (T Hadvani, E Choy, C Molleda, V Parikh, MA Lopez, K Lui, K Ban, and SS Wallace), Section of Pediatric Hospital Medicine, Baylor College of Medicine, Houston, Tex.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Lopez', 'Affiliation': 'Department of Pediatrics (T Hadvani, E Choy, C Molleda, V Parikh, MA Lopez, K Lui, K Ban, and SS Wallace), Section of Pediatric Hospital Medicine, Baylor College of Medicine, Houston, Tex.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lui', 'Affiliation': 'Department of Pediatrics (T Hadvani, E Choy, C Molleda, V Parikh, MA Lopez, K Lui, K Ban, and SS Wallace), Section of Pediatric Hospital Medicine, Baylor College of Medicine, Houston, Tex.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Ban', 'Affiliation': 'Department of Pediatrics (T Hadvani, E Choy, C Molleda, V Parikh, MA Lopez, K Lui, K Ban, and SS Wallace), Section of Pediatric Hospital Medicine, Baylor College of Medicine, Houston, Tex.'}, {'ForeName': 'Sowdhamini S', 'Initials': 'SS', 'LastName': 'Wallace', 'Affiliation': 'Department of Pediatrics (T Hadvani, E Choy, C Molleda, V Parikh, MA Lopez, K Lui, K Ban, and SS Wallace), Section of Pediatric Hospital Medicine, Baylor College of Medicine, Houston, Tex.'}]",Academic pediatrics,['10.1016/j.acap.2020.09.012']
3004,32986748,"Efficacy of processed amaranth-containing bread compared to maize bread on hemoglobin, anemia and iron deficiency anemia prevalence among two-to-five year-old anemic children in Southern Ethiopia: A cluster randomized controlled trial.","BACKGROUND
Few studies have evaluated iron-rich plant-based foods, such as amaranth grain, to reduce anemia and iron deficiency anemia. Amaranth is rich in nutrients, but with high level of phytate. The objective of this trial was to evaluate the efficacy of home processed amaranth grain containing bread in the treatment of anemia, hemoglobin concentration and iron deficiency anemia among two-to-five year-old children in Southern Ethiopia.
METHOD
Children with anemia (hemoglobin concentration <110.0g/L) (N = 100) were identified by random sampling and enrolled in a 1:1 cluster randomized controlled trial for six months in 2017. The amaranth group (N = 50), received 150g bread containing 70% amaranth and 30% chickpea, the amaranth grain was processed at home (soaking, germinating, and fermenting) to decrease the phytate level. The maize group (N = 50), received 150g bread, containing processed maize (roasted and fermented) to give a similar color and structure with amaranth bread. Hemoglobin, ferritin, and CRP were measured at baseline and at the end of intervention. Hemoglobin and ferritin values were adjusted for altitude and infection, respectively. Generalized estimating equation and generalized linear model were used to analyze the data.
RESULT
In the last follow-up measure anemia prevalence was significantly lower in the amaranth group (32%) as compared with the maize group (56%) [adjusted risk ratios, aRR: 0.39 (95%CI: 0.16-0.77)]. Hemoglobin concentration estimate of beta coefficient was significantly higher in the amaranth group compared with the maize group [aβ 8.9g/L (95%CI: 3.5-14.3)], p-value <0.01. The risk of iron deficiency anemia is significantly lower in the amaranth group [aRR: 0.44 (95%CI: 0.23-0.83)] in the intention to treat analysis but not significant in the complete case analysis. There was no significant difference between groups in iron deficiency [aRR: 0.81 (95%CI: 0.55-1.19)].
CONCLUSION
Processed amaranth bread had favorable effects on hemoglobin concentration and has the potential to minimize anemia prevalence.
CLINICAL TRIAL REGISTRATION
Trial registry number: PACTR201705002283263 https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2283.",2020,"In the last follow-up measure anemia prevalence was significantly lower in the amaranth group (32%) as compared with the maize group (56%) [adjusted risk ratios, aRR:","['two-to-five year-old children in Southern Ethiopia', 'Children with anemia (hemoglobin concentration <110.0g/L', 'two-to-five year-old anemic children in Southern Ethiopia']","['150g bread containing 70% amaranth and 30% chickpea, the amaranth grain', '150g bread, containing processed maize (roasted and fermented) to give a similar color and structure with amaranth bread', 'processed amaranth-containing bread compared to maize bread', 'home processed amaranth grain containing bread']","['Hemoglobin concentration estimate of beta coefficient', 'Hemoglobin, ferritin, and CRP', 'anemia, hemoglobin concentration and iron deficiency anemia', 'risk of iron deficiency anemia', 'Hemoglobin and ferritin values', 'hemoglobin, anemia and iron deficiency anemia prevalence', 'iron deficiency [aRR: 0.81', 'hemoglobin concentration', 'anemia prevalence', 'risk ratios, aRR']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}]","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002406', 'cui_str': 'Amaranth Dye'}, {'cui': 'C0950052', 'cui_str': 'Chick peas'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",100.0,0.17653,"In the last follow-up measure anemia prevalence was significantly lower in the amaranth group (32%) as compared with the maize group (56%) [adjusted risk ratios, aRR:","[{'ForeName': 'Alemselam Zebdewos', 'Initials': 'AZ', 'LastName': 'Orsango', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia.'}, {'ForeName': 'Eskindir', 'Initials': 'E', 'LastName': 'Loha', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia.'}, {'ForeName': 'Bernt', 'Initials': 'B', 'LastName': 'Lindtjørn', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia.'}, {'ForeName': 'Ingunn Marie S', 'Initials': 'IMS', 'LastName': 'Engebretsen', 'Affiliation': 'Centre for International Health, University of Bergen, Bergen, Norway.'}]",PloS one,['10.1371/journal.pone.0239192']
3005,32986758,Radiofrequency ablation using internally cooled wet electrodes in bipolar mode for the treatment of recurrent hepatocellular carcinoma after locoregional treatment: A randomized prospective comparative study.,"OBJECTIVE
This study aimed to compare the efficacy between bipolar radiofrequency ablation (RFA), using twin internally cooled wet (TICW) electrodes, and switching monopolar RFA, using separable clustered (SC) electrodes, in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.
MATERIALS AND METHODS
In this single-center, two-arm, parallel-group, randomized controlled study, we performed a 1:1 random allocation on eligible patients with recurrent HCC after locoregional treatment, to receive TICW-RFA or SC-RFA. The primary endpoint was the minimum diameter of the ablation zone per unit ablation time. Secondary endpoints included other technical parameters, complication rate, technical success and technique efficacy, and clinical outcomes.
RESULTS
Enrolled patients were randomly assigned to the TICW-RFA group (n = 40) or SC-RFA group (n = 37). The two groups did not show significant differences in the primary endpoint, the minimum diameter of the ablation zone per unit ablation time was 2.71 ± 0.98 mm/min and 2.61 ± 0.96 mm/min in the TICW-RFA and SC-RFA groups, respectively (p = 0.577). Total RF energy delivery (11.75 ± 9.04 kcal vs. 22.61 ± 12.98 kcal, p < 0.001) and energy delivery per unit time (0.81 ± 0.49 kcal/min vs. 1.45 ± 0.42 kcal/min, p < 0.001) of the TICW-RFA group were less than those of the SC-RFA group. No procedure-related death or major complications occurred. Technical success was achieved in all patients in both groups, and technique efficacy rates were 100% (46/46) in the TICW-RFA group and 95.0% (38/40) in the SC-RFA group (p = 0.213). The 1-year and 2-year cumulative LTP rates were 11.8% and 24.2%, respectively, in the TICW-RFA group, and 8.6% and 18.1%, respectively, in the SC-RFA group (p = 0.661).
CONCLUSION
In this single-center randomized controlled study from a Korean tertiary referral hospital, TICW-RFA demonstrated similar therapeutic efficacy and safety profile for recurrent HCC after locoregional treatment compared with SC-RFA.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT03806218).",2020,"The two groups did not show significant differences in the primary endpoint, the minimum diameter of the ablation zone per unit ablation time was 2.71 ± 0.98 mm/min and 2.61 ± 0.96 mm/min in the TICW-RFA and SC-RFA groups, respectively (p = 0.577).","['eligible patients with recurrent HCC after locoregional treatment, to receive', 'recurrent hepatocellular carcinoma after locoregional treatment', 'recurrent hepatocellular carcinoma (HCC) after locoregional treatment']","['Radiofrequency ablation using internally cooled wet electrodes', 'TICW-RFA or SC-RFA', 'SC-RFA', 'bipolar radiofrequency ablation (RFA), using twin internally cooled wet (TICW) electrodes, and switching monopolar RFA, using separable clustered (SC) electrodes', 'TICW-RFA']","['minimum diameter of the ablation zone per unit ablation time', 'technique efficacy rates', 'technical parameters, complication rate, technical success and technique efficacy, and clinical outcomes', 'Technical success', '1-year and 2-year cumulative LTP rates', 'Total RF energy delivery', 'energy delivery per unit time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0861876', 'cui_str': 'Hepatocellular carcinoma recurrent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206249', 'cui_str': 'Long-Term Potentiation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",,0.066154,"The two groups did not show significant differences in the primary endpoint, the minimum diameter of the ablation zone per unit ablation time was 2.71 ± 0.98 mm/min and 2.61 ± 0.96 mm/min in the TICW-RFA and SC-RFA groups, respectively (p = 0.577).","[{'ForeName': 'Jae Won', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Jeong Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Jung-Hwan', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Su Jong', 'Initials': 'SJ', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Eun Ju', 'Initials': 'EJ', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0239733']
3006,32986828,"Race, ethnicity and clinical outcomes in hormone receptor-positive, HER2-negative, node-negative breast cancer in the randomized TAILORx trial.","BACKGROUND
Black race is associated with worse outcomes in early breast cancer. We evaluated clinicopathologic characteristics, the 21-gene Recurrence Score (RS), treatment delivered and clinical outcomes by race and ethnicity among women who participated in TAILORx.
METHODS
The association between clinical outcomes and race (White, Black, Asian, other/unknown) and ethnicity (Hispanic vs. non-Hispanic) was examined using proportional hazards models. All P values are two-sided.
RESULTS
Of 9719 eligible women with hormone-receptor-positive, HER2-negative, node-negative breast cancer, there were 8189 (84.3%) Whites, 693 (7,1%) Blacks, 405 (4.2%) Asians, and 432 (4,4%) with other/unknown race. Regarding ethnicity, 889 (9,1%) were Hispanic. There were no substantial differences in RS or ESR1, PgR, or HER2 RNA expression by race or ethnicity. After adjustment for other covariates, compared with White race, Black race was associated with higher distant recurrence rates (hazard ratio [HR] = 1.60, 95% confidence intervals [CI] = 1.07 to 2.41), and worse overall survival in the RS 11-25 cohort (HR = 1.51, 95% CI = 1.06 to 2.15) and entire population (HR = 1.41, 95% CI = 1.05 to 1.90). Hispanic ethnicity and Asian race were associated with better outcomes. There was no evidence of chemotherapy benefit for any racial or ethnic group in those with a RS of 11-25.
CONCLUSIONS
Black women had worse clinical outcomes despite similar 21-gene assay RS results and comparable systemic therapy in TAILORx. Similar to Whites, Black women did not benefit from adjuvant chemotherapy if the 21-gene RS was 11-25. Further research is required to elucidate the basis for this racial disparity in prognosis.",2020,"There were no substantial differences in RS or ESR1, PgR, or HER2 RNA expression by race or ethnicity.","['Of 9719', 'women who participated in TAILORx', 'eligible women with hormone-receptor-positive, HER2-negative, node-negative breast cancer, there were 8189 (84.3%) Whites, 693 (7,1%) Blacks, 405 (4.2%) Asians, and 432 (4,4%) with other/unknown race']",[],"['21-gene Recurrence Score (RS), treatment delivered and clinical outcomes by race and ethnicity', 'distant recurrence rates', 'RS or ESR1, PgR, or HER2 RNA expression by race or ethnicity', 'Hispanic ethnicity and Asian race', 'overall survival']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}]",[],"[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",9719.0,0.203342,"There were no substantial differences in RS or ESR1, PgR, or HER2 RNA expression by race or ethnicity.","[{'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Cardinal Bernadin Cancer Center, Loyola University Medical Center, Maywood, IL.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Della F', 'Initials': 'DF', 'LastName': 'Makower', 'Affiliation': 'Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Faghih', 'Affiliation': 'Thunder Bay Regional Health Science Centre, Thunder Bay, Ontario.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'Houston Methodist Cancer Center, Houston, TX.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Dees', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Olson', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Lively', 'Affiliation': 'National Institutes of Health, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Badve', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Saphner', 'Affiliation': 'Aurora Health Care, Two Rivers, WI.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Service, Winston Salem, NC.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Whelan', 'Affiliation': 'McMaster University, Hamilton, Canada.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Ellis', 'Affiliation': 'Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Wood', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Maccon M', 'Initials': 'MM', 'LastName': 'Keane', 'Affiliation': 'Cancer Trials Ireland, Dublin, Ireland.'}, {'ForeName': 'Henry L', 'Initials': 'HL', 'LastName': 'Gomez', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru.'}, {'ForeName': 'Pavan S', 'Initials': 'PS', 'LastName': 'Reddy', 'Affiliation': 'Cancer Center of Kansas, Wichita, KS.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Goggins', 'Affiliation': 'Fox Valley Hematology and Oncology, Appleton, WI.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Brufsky', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Toppmeyer', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ.'}, {'ForeName': 'Virginia G', 'Initials': 'VG', 'LastName': 'Kaklamani', 'Affiliation': 'University of Texas, San Antonio, TX.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Berenberg', 'Affiliation': 'University of Hawaii Cancer Center, Honolulu, HI.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Abrams', 'Affiliation': 'National Institutes of Health, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Stanford University, Stanford, CA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djaa148']
3007,32992440,"Gastrointestinal Tolerance of Low, Medium and High Dose Acute Oral l-Glutamine Supplementation in Healthy Adults: A Pilot Study.","l-Glutamine (GLN) is a conditionally essential amino acid which supports gastrointestinal (GI) and immune function prior to catabolic stress (e.g., strenuous exercise). Despite potential dose-dependent benefits, GI tolerance of acute high dose oral GLN supplementation is poorly characterised. Fourteen healthy males (25 ± 5 years; 1.79 ± 0.07 cm; 77.7 ± 9.8 kg; 14.8 ± 4.6% body fat) ingested 0.3 (LOW), 0.6 (MED) or 0.9 (HIGH) g·kg·FFM -1 GLN beverages, in a randomised, double-blind, counter-balanced, cross-over trial. Individual and accumulated GI symptoms were recorded using a visual analogue scale at regular intervals up to 24-h post ingestion. GLN beverages were characterised by tonicity measurement and microscopic observations. 24-h accumulated upper- and lower- and total-GI symptoms were all greater in the HIGH, compared to LOW and MED trials ( p < 0.05). Specific GI symptoms (discomfort, nausea, belching, upper GI pain) were all more pronounced on the HIGH versus LOW GLN trial ( p < 0.05). Nevertheless, most symptoms were still rated as mild. In comparison, the remaining GI symptoms were either comparable (flatulence, urge to regurgitate, bloating, lower GI pain) or absent (heart burn, vomiting, urge to defecate, abnormal stools, stitch, dizziness) between trials ( p > 0.05). All beverages were isotonic and contained a dose-dependent number of GLN crystals. Acute oral GLN ingestion in dosages up to 0.9 g·kg·FFM -1 are generally well-tolerated. However, the severity of mild GI symptoms appeared dose-dependent during the first two hours post prandial and may be due to high-concentrations of GLN crystals.",2020,"24-h accumulated upper- and lower- and total-GI symptoms were all greater in the HIGH, compared to LOW and MED trials ( p < 0.05).","['Healthy Adults', 'Fourteen healthy males (25 ± 5 years; 1.79 ± 0.07 cm; 77.7 ± 9.8 kg; 14.8 ± 4.6% body fat) ingested 0.3 (LOW), 0.6 (MED) or 0.9 (HIGH']","['l-Glutamine (GLN', 'Low, Medium and High Dose Acute Oral l-Glutamine Supplementation']","['24-h accumulated upper- and lower- and total-GI symptoms', 'severity of mild GI symptoms', 'Specific GI symptoms (discomfort, nausea, belching, upper GI pain', 'Individual and accumulated GI symptoms', 'flatulence, urge to regurgitate, bloating, lower GI pain) or absent (heart burn, vomiting, urge to defecate, abnormal stools, stitch, dizziness']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4518239', 'cui_str': '0.07'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0014724', 'cui_str': 'Eructation'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0687713', 'cui_str': 'Gastrointestinal pain'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0162287', 'cui_str': 'Abnormal feces'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",14.0,0.160877,"24-h accumulated upper- and lower- and total-GI symptoms were all greater in the HIGH, compared to LOW and MED trials ( p < 0.05).","[{'ForeName': 'Henry B', 'Initials': 'HB', 'LastName': 'Ogden', 'Affiliation': 'Faculty of Sport, Health and Wellbeing, Plymouth MARJON University, Plymouth PL6 8BH, UK.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Child', 'Affiliation': 'School of Chemical Engineering, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Joanne L', 'Initials': 'JL', 'LastName': 'Fallowfield', 'Affiliation': 'Institute of Naval Medicine, Alverstoke PO12 2DL, UK.'}, {'ForeName': 'Simon K', 'Initials': 'SK', 'LastName': 'Delves', 'Affiliation': 'Institute of Naval Medicine, Alverstoke PO12 2DL, UK.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Westwood', 'Affiliation': 'Faculty of Sport, Health and Wellbeing, Plymouth MARJON University, Plymouth PL6 8BH, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Millyard', 'Affiliation': 'Faculty of Sport, Health and Wellbeing, Plymouth MARJON University, Plymouth PL6 8BH, UK.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Layden', 'Affiliation': 'Faculty of Sport, Health and Wellbeing, Plymouth MARJON University, Plymouth PL6 8BH, UK.'}]",Nutrients,['10.3390/nu12102953']
3008,32992726,Transcutaneous Vagus Nerve Stimulation Modulates EEG Microstates and Delta Activity in Healthy Subjects.,"Transcutaneous vagus nerve stimulation (tVNS) is an alternative non-invasive method for the electrical stimulation of the vagus nerve with the goal of treating several neuropsychiatric disorders. The objective of this study is to assess the effects of tVNS on cerebral cortex activity in healthy volunteers using resting-state microstates and power spectrum electroencephalography (EEG) analysis. Eight male subjects aged 25-45 years were recruited in this randomized sham-controlled double-blind study with cross-over design. Real tVNS was administered at the left external acoustic meatus, while sham stimulation was performed at the left ear lobe, both of them for 60 min. The EEG recording lasted 5 min and was performed before and 60 min following the tVNS experimental session. We observed that real tVNS induced an increase in the metrics of microstate A mean duration ( p = 0.039) and an increase in EEG power spectrum activity in the delta frequency band ( p < 0.01). This study confirms that tVNS is an effective way to stimulate the vagus nerve, and the mechanisms of action of this activation can be successfully studied using scalp EEG quantitative metrics. Future studies are warranted to explore the clinical implications of these findings and to focus the research of the prognostic biomarkers of tVNS therapy for neuropsychiatric diseases.",2020,Transcutaneous vagus nerve stimulation (tVNS) is an alternative non-invasive method for the electrical stimulation of the vagus nerve with the goal of treating several neuropsychiatric disorders.,"['Eight male subjects aged 25-45 years', 'healthy volunteers using resting-state microstates and power spectrum electroencephalography (EEG) analysis', 'Healthy Subjects']","['tVNS', 'Transcutaneous Vagus Nerve Stimulation Modulates EEG', 'Transcutaneous vagus nerve stimulation (tVNS']","['metrics of microstate A mean duration', 'cerebral cortex activity', 'EEG power spectrum activity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007776', 'cui_str': 'Structure of cerebral cortex'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",8.0,0.0218572,Transcutaneous vagus nerve stimulation (tVNS) is an alternative non-invasive method for the electrical stimulation of the vagus nerve with the goal of treating several neuropsychiatric disorders.,"[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Ricci', 'Affiliation': 'Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, University Campus Bio-Medico of Rome, via Álvaro del Portillo, 21, 00128 Rome, Italy.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Croce', 'Affiliation': ""Department of Neuroscience, Imaging and Clinical Sciences, G. d'Annunzio University of Chieti-Pescara, 66100 Chieti, Italy.""}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Lanzone', 'Affiliation': 'Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, University Campus Bio-Medico of Rome, via Álvaro del Portillo, 21, 00128 Rome, Italy.'}, {'ForeName': 'Marilisa', 'Initials': 'M', 'LastName': 'Boscarino', 'Affiliation': 'Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, University Campus Bio-Medico of Rome, via Álvaro del Portillo, 21, 00128 Rome, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Zappasodi', 'Affiliation': ""Department of Neuroscience, Imaging and Clinical Sciences, G. d'Annunzio University of Chieti-Pescara, 66100 Chieti, Italy.""}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Tombini', 'Affiliation': 'Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, University Campus Bio-Medico of Rome, via Álvaro del Portillo, 21, 00128 Rome, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Di Lazzaro', 'Affiliation': 'Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, University Campus Bio-Medico of Rome, via Álvaro del Portillo, 21, 00128 Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Assenza', 'Affiliation': 'Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, University Campus Bio-Medico of Rome, via Álvaro del Portillo, 21, 00128 Rome, Italy.'}]",Brain sciences,['10.3390/brainsci10100668']
3009,32992759,CaRE @ Home: Pilot Study of an Online Multidimensional Cancer Rehabilitation and Exercise Program for Cancer Survivors.,"BACKGROUND
Although facility-based cancer rehabilitation and exercise programs exist, patients are often unable to attend due to distance, cost, and other competing obligations. There is a need for scalable remote interventions that can reach and serve a larger population.
METHODS
We conducted a mixed methods pilot study to assess the feasibility, acceptability and impact of CaRE@Home: an 8-week online multidimensional cancer rehabilitation and exercise program. Feasibility and acceptability data were captured by attendance and adherence metrics and through qualitative interviews. Preliminary estimates of the effects of CaRE@Home on patient-reported and physically measured outcomes were calculated.
RESULTS
A total of n = 35 participated in the study. Recruitment (64%), retention (83%), and adherence (80%) rates, along with qualitative findings, support the feasibility of the CaRE@Home intervention. Acceptability was also high, and participants provided useful feedback for program improvements. Disability (WHODAS 2.0) scores significantly decreased from baseline (T1) to immediately post-intervention (T2) and three months post-intervention (T3) ( p = 0.03 and p = 0.008). Physical activity (GSLTPAQ) levels significantly increased for both Total LSI ( p = 0.007 and p = 0.0002) and moderate to strenuous LSI ( p = 0.003 and p = 0.002) from baseline to T2 and T3. Work productivity (iPCQ) increased from T1 to T3 ( p = 0.026). There was a significant increase in six minute walk distance from baseline to T2 and T3 ( p < 0.001 and p = 0.010) and in grip strength from baseline to T2 and T3 ( p = 0.003 and p < 0.001).
CONCLUSIONS
Results indicate that the CaRE@Home program is a feasible and acceptable cancer rehabilitation program that may help cancer survivors regain functional ability and decrease disability. In order to confirm these findings, a controlled trial is required.",2020,Physical activity (GSLTPAQ) levels significantly increased for both Total LSI ( p = 0.007 and p = 0.0002) and moderate to strenuous LSI ( p = 0.003 and p = 0.002) from baseline to T2 and T3.,"['Cancer Survivors', 'A total of n = 35 participated in the study']","['CaRE@Home program', 'CaRE ', 'Online Multidimensional Cancer Rehabilitation and Exercise Program', 'CaRE@Home']","['six minute walk distance', 'Physical activity (GSLTPAQ) levels', 'Work productivity (iPCQ', 'Feasibility and acceptability data', 'moderate to strenuous LSI', 'grip strength', 'Acceptability', 'Disability (WHODAS 2.0) scores']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3854375', 'cui_str': 'Laser speckle contrast imaging'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0691581,Physical activity (GSLTPAQ) levels significantly increased for both Total LSI ( p = 0.007 and p = 0.0002) and moderate to strenuous LSI ( p = 0.003 and p = 0.002) from baseline to T2 and T3.,"[{'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'MacDonald', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Chafranskaia', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Lopez', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Maganti', 'Affiliation': 'Department of Biostatistics, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Bernstein', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Chang', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'David Michael', 'Initials': 'DM', 'LastName': 'Langelier', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Obadia', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Edwards', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Oh', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada.'}, {'ForeName': 'Jacqueline L', 'Initials': 'JL', 'LastName': 'Bender', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Shabbir Mh', 'Initials': 'SM', 'LastName': 'Alibhai', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Jones', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada.'}]",Journal of clinical medicine,['10.3390/jcm9103092']
3010,32992871,High-Intensity Interval Training Is Effective at Increasing Exercise Endurance Capacity and Is Well Tolerated by Adults with Cystic Fibrosis.,"BACKGROUND
To optimize outcomes in people with cystic fibrosis (CF), guidelines recommend 30 to 60 min of moderate-intensity aerobic exercise on most days. Accumulating this volume of exercise contributes importantly to the substantial treatment burden associated with CF. Therefore, the main aim of this study was to investigate the effects of low-volume high-intensity interval training (HIIT) on exercise capacity in people with CF.
METHODS
This randomized controlled trial included people with CF aged ≥15 years, who were allocated to either eight weeks of thrice-weekly 10-min sessions of HIIT (experimental group) or eight weeks of weekly contact (control group). Before and after the intervention period, participants completed measurements of time to symptom limitation (T lim ) during a constant work rate cycle ergometry test (primary outcome), and maximal work rate (W max ) during a ramp-based cycle ergometry test and health-related quality of life (HRQoL).
RESULTS
Fourteen participants (median (IQR) age 31 (28, 35) years, forced expiratory volume in 1 second (FEV 1 ) 61 (45, 80) % predicted) were included (seven in each group). Compared to the control group, participants in the experimental group demonstrated a greater magnitude of change in T lim , W max ( p = 0.017 for both) and in the physical function domain of HRQoL ( p = 0.03). No other between-group differences were demonstrated. Mild post-exercise muscle soreness was reported on a single occasion by four participants. Overall, participants attended 93% of all HIIT sessions.
DISCUSSION
Eight weeks of low-volume (i.e., 30-min/week) HIIT produced gains in exercise capacity and self-reported physical function and was well tolerated by people with CF.",2020,"Compared to the control group, participants in the experimental group demonstrated a greater magnitude of change in T lim , W max ( p = 0.017 for both) and in the physical function domain of HRQoL ( p = 0.03).","['people with CF aged ≥15 years', 'Adults with Cystic Fibrosis', 'Fourteen participants (median (IQR) age 31 (28, 35) years, forced expiratory volume in 1 second (FEV 1 ) 61 (45, 80) % predicted) were included (seven in each group', 'people with CF', 'people with cystic fibrosis (CF']","['low-volume high-intensity interval training (HIIT', 'High-Intensity Interval Training']","['time to symptom limitation (T lim ) during a constant work rate cycle ergometry test (primary outcome), and maximal work rate (W max ) during a ramp-based cycle ergometry test and health-related quality of life (HRQoL', 'magnitude of change in T lim , W max', 'exercise capacity', 'exercise capacity and self-reported physical function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.114533,"Compared to the control group, participants in the experimental group demonstrated a greater magnitude of change in T lim , W max ( p = 0.017 for both) and in the physical function domain of HRQoL ( p = 0.03).","[{'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Sawyer', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Kent Street, Bentley, WA 6102, Australia.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Cavalheri', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Kent Street, Bentley, WA 6102, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jenkins', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Kent Street, Bentley, WA 6102, Australia.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Kent Street, Bentley, WA 6102, Australia.'}, {'ForeName': 'Nola', 'Initials': 'N', 'LastName': 'Cecins', 'Affiliation': 'Physiotherapy Department, Sir Charles Gairdner Hospital, Perth, WA 6009, Australia.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Bear', 'Affiliation': 'Institute of Health Research, Fremantle Campus, University of Notre Dame Australia, Fremantle, WA 6160, Australia.'}, {'ForeName': 'Bhajan', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'West Australian Sleep Disorders Research Institute, Nedlands, WA 6009, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gucciardi', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Kent Street, Bentley, WA 6102, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Kent Street, Bentley, WA 6102, Australia.'}]",Journal of clinical medicine,['10.3390/jcm9103098']
3011,32916250,Impact of dedicated infectious disease teamwork on the treatment and prognosis of patients with diabetic foot infection.,"OBJECTIVE
The aim was to develop and evaluate the impact of a new model in which the infectious disease (ID) physician and pharmacist work together to treat diabetic foot infections (DFIs).
METHODS
A quasi-experimental before-after study was conducted. The medical charts of inpatients with DFI admitted between April 1, 2017 and March 31, 2018 were reviewed retrospectively (control group, n = 30). Inpatients diagnosed with DFI between April 1, 2018 and March 31, 2019 were enrolled prospectively as the intervention group and received treatment through dedicated ID teamwork (intervention group, n = 35).
RESULTS
The distribution of infection severity and levels of metabolic criteria were similar in the two groups. Compared with the control group, the intervention group received adequate initial empirical treatment more frequently (96.8% vs 43.5%, p < 0.001) and had a shorter median duration of fever (1 day vs 7.5 days, p < 0.001). Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
CONCLUSION
The early and full participation of ID physicians and pharmacists in the treatment of DFI facilitated targeted antimicrobial treatment and improved patient outcomes.",2020,"Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
","['inpatients with DFI admitted between April 1, 2017 and March 31, 2018 were reviewed retrospectively (control group, n = 30', 'patients with diabetic foot infection', 'Inpatients diagnosed with DFI between April 1, 2018 and March 31, 2019 were enrolled prospectively as the intervention group and received treatment through dedicated ID teamwork (intervention group, n = 35']",['dedicated infectious disease teamwork'],"['Rates of healing and relapse', 'sites of osteomyelitis', 'distribution of infection severity and levels of metabolic criteria', 'polymicrobial infections', 'shorter median duration of fever']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0744130', 'cui_str': 'Diabetic foot infection'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0029443', 'cui_str': 'Osteomyelitis'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0517627', 'cui_str': 'Infection status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",,0.0350705,"Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
","[{'ForeName': 'Xiang-Yan', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Department of Anti-infection, Institute of Clinical Pharmacology, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: lixyan03598@pkufh.com.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: 04983@pkufh.com.'}, {'ForeName': 'Shuo-Han', 'Initials': 'SH', 'LastName': 'Tian', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: tianshuohan@126.com.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'He', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: doctorherui@163.com.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: jiangshan_beijing@163.com.'}, {'ForeName': 'Hui-Juan', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: lihuijuan2010@126.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.085']
3012,32994487,Safety and functional enrichment of gut microbiome in healthy subjects consuming a multi-strain fermented milk product: a randomised controlled trial.,"Many clinical studies have evaluated the effect of probiotics, but only a few have assessed their dose effects on gut microbiota and host. We conducted a randomized, double-blind, controlled intervention clinical trial to assess the safety (primary endpoint) of and gut microbiota response (secondary endpoint) to the daily ingestion for 4 weeks of two doses (1 or 3 bottles/day) of a fermented milk product (Test) in 96 healthy adults. The Test product is a multi-strain fermented milk product, combining yogurt strains and probiotic candidate strains Lactobacillus paracasei subsp. paracasei CNCM I-1518 and CNCM I-3689 and Lactobacillus rhamnosus CNCM I-3690. We assessed the safety of the Test product on the following parameters: adverse events, vital signs, hematological and metabolic profile, hepatic, kidney or thyroid function, inflammatory markers, bowel habits and digestive symptoms. We explored the longitudinal gut microbiota response to product consumption and dose, by 16S rRNA gene sequencing and functional contribution by shotgun metagenomics. Safety results did not show any significant difference between the Test and Control products whatever the parameters assessed, at the two doses ingested daily over a 4-week-period. Probiotic candidate strains were detected only during consumption period, and at a significantly higher level for the three strains in subjects who consumed 3 products bottles/day. The global structure of the gut microbiota as assessed by alpha and beta-diversity, was not altered by consumption of the product for four weeks. A zero-inflated beta regression model with random effects (ZIBR) identified a few bacterial genera with differential responses to test product consumption dose compared to control. Shotgun metagenomics analysis revealed a functional contribution to the gut microbiome of probiotic candidates.",2020,"Safety results did not show any significant difference between the Test and Control products whatever the parameters assessed, at the two doses ingested daily over a 4-week-period.","['96 healthy adults', 'healthy subjects consuming a multi-strain fermented milk product']","['gut microbiome', 'paracasei CNCM I-1518 and CNCM I-3689 and Lactobacillus rhamnosus', 'fermented milk product (Test']","['adverse events, vital signs, hematological and metabolic profile, hepatic, kidney or thyroid function, inflammatory markers, bowel habits and digestive symptoms']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C1257811', 'cui_str': 'Milk Products, Cultured'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C1257811', 'cui_str': 'Milk Products, Cultured'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0476288', 'cui_str': 'Digestive symptom'}]",96.0,0.0775708,"Safety results did not show any significant difference between the Test and Control products whatever the parameters assessed, at the two doses ingested daily over a 4-week-period.","[{'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Alvarez', 'Affiliation': 'Danone Nutricia Research, Palaiseau, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Tap', 'Affiliation': 'Danone Nutricia Research, Palaiseau, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chambaud', 'Affiliation': 'Danone Nutricia Research, Palaiseau, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Cools-Portier', 'Affiliation': 'Danone Nutricia Research, Palaiseau, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Quinquis', 'Affiliation': 'Danone Nutricia Research, Palaiseau, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bourlioux', 'Affiliation': 'Faculty of Pharmacy - Paris-Sud University, Chatenay-Malabry, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Marteau', 'Affiliation': 'APHP, Sorbonne Université - INSERM-ERL 1157 - UMR7203, Hôpital Tenon, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Guillemard', 'Affiliation': 'Danone Nutricia Research, Palaiseau, France.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Schrezenmeir', 'Affiliation': 'Clinical Research Center Kiel, Kiel Innovation and Technology Center, Schauenburgerstr., Kiel, Germany.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Derrien', 'Affiliation': 'Danone Nutricia Research, Palaiseau, France. muriel.derrien@danone.com.'}]",Scientific reports,['10.1038/s41598-020-72161-w']
3013,32994490,"Reduction of fatigue and anger-hostility by the oral administration of 5-aminolevulinic acid phosphate: a randomized, double-blind, placebo-controlled, parallel study.","Although large populations feel fatigue, the standardized medicinal therapy is currently absent. In this study, we determined whether 5-aminolevulinic acid (5-ALA) supplementation alleviates the feeling of fatigue in healthy subjects who feel chronic physical tiredness. Males and females between ages of 20 and 64 who felt physical fatigue on a daily basis, with a visual analogue scale (VAS) for fatigue ≥ 40 mm, a T-score of Fatigue-Inertia in the Profile of Mood States-Second Edition-Adult (POMS2-A) ≥ 50, and a T-score of Vigor-Activity in POMS2-A ≤ 60 were recruited. Seventy eligible participants were randomly assigned to either a 5-ALA or a placebo group. During the 8 weeks of consumption, the subjects completed VAS questionnaires for fatigue and POMS2-A at 4-week intervals. The VAS values for overall feeling of fatigue and feeling of work-related fatigue, and the Anger-Hostility subscale of POMS2-A were decreased by 5-ALA with significant time × group interaction effects (p = 0.040, 0.020, and 0.045, respectively). Besides, the 5-ALA group showed significant differences in Fatigue-Inertia, Depression-Dejection and Total Mood Disturbance scores, when compared between pre- and post-intervention, while the placebo group did not. In conclusion, the oral administration of 5-ALA improves fatigue and negative mood in subjects who constantly feel physical fatigue.This clinical trial was registered with University hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) as UMIN000031528 on 2/3/2018.",2020,"Besides, the 5-ALA group showed significant differences in Fatigue-Inertia, Depression-Dejection and Total Mood Disturbance scores, when compared between pre- and post-intervention, while the placebo group did not.","['subjects who constantly feel physical fatigue', 'Seventy eligible participants', 'Males and females between ages of 20 and 64 who felt physical fatigue on a daily basis, with a visual analogue scale (VAS) for fatigue\u2009≥', 'healthy subjects who feel chronic physical tiredness']","['5-aminolevulinic acid (5-ALA) supplementation', '5-ALA', 'placebo', '5-aminolevulinic acid phosphate']","['VAS values for overall feeling of fatigue and feeling of work-related fatigue, and the Anger-Hostility subscale of POMS2-A', 'Fatigue-Inertia, Depression-Dejection and Total Mood Disturbance scores', 'Reduction of fatigue and anger-hostility', 'feeling of fatigue', 'fatigue and negative mood']","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",70.0,0.235424,"Besides, the 5-ALA group showed significant differences in Fatigue-Inertia, Depression-Dejection and Total Mood Disturbance scores, when compared between pre- and post-intervention, while the placebo group did not.","[{'ForeName': 'Fumiko', 'Initials': 'F', 'LastName': 'Higashikawa', 'Affiliation': 'Department of Probiotic Science for Preventive Medicine, Graduate School of Biomedical and Health Sciences, Hiroshima University, Kasumi 1-2-3, Minami-ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Keishi', 'Initials': 'K', 'LastName': 'Kanno', 'Affiliation': 'Department of General Internal Medicine, Hiroshima University Hospital, 1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Ogata', 'Affiliation': 'Department of Psychology, Graduate School of Education, Hiroshima University, 1-1-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, 739-8511, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Probiotic Science for Preventive Medicine, Graduate School of Biomedical and Health Sciences, Hiroshima University, Kasumi 1-2-3, Minami-ku, Hiroshima, 734-8551, Japan. sugi@hiroshima-u.ac.jp.'}]",Scientific reports,['10.1038/s41598-020-72763-4']
3014,32994531,Medium cut-off dialyzer improves erythropoiesis stimulating agent resistance in a hepcidin-independent manner in maintenance hemodialysis patients: results from a randomized controlled trial.,"The response to erythropoiesis stimulating agents (ESAs) is affected by inflammation linked to middle molecules in hemodialysis (HD) patients. We evaluated the effect of a medium cut-off (MCO) dialyzer on ESA resistance in maintenance HD patients. Forty-nine patients who underwent high-flux HD were randomly allocated to the MCO or high-flux group. The primary outcome was the changes of erythropoietin resistance index (ERI; U/kg/wk/g/dL) between baseline and 12 weeks. The MCO group showed significant decrease in the ESA dose, weight-adjusted ESA dose, and ERI compared to the high-flux group at 12 weeks (p < 0.05). The generalized estimating equation models revealed significant interactions between groups and time for the ESA dose, weight-adjusted ESA dose, and ERI (p < 0.05). Serum iron and transferrin saturation were higher in the MCO group at 12 weeks (p < 0.05). The MCO group showed a greater reduction in TNF-α and lower serum TNF-α level at 12 weeks compared to the high-flux group (p < 0.05), whereas no differences were found in the reduction ratio of hepcidin and serum levels of erythropoietin, erythroferrone, soluble transferrin receptor and hepcidin between groups. HD with MCO dialyzer improves ESA resistance over time compared to high-flux HD in maintenance HD patients. The MCO dialyzer provides superior removal of the inflammatory cytokine and thus improves iron metabolism in a hepcidin-independent manner.",2020,"TNF-α level at 12 weeks compared to the high-flux group (p < 0.05), whereas no differences were found in the reduction ratio of hepcidin and serum levels of erythropoietin, erythroferrone, soluble transferrin receptor and hepcidin between groups.","['Forty-nine patients who underwent high-flux HD', 'maintenance HD patients', 'maintenance hemodialysis patients', 'hemodialysis (HD) patients']","['Medium cut-off dialyzer', 'MCO or high-flux group', 'erythropoiesis stimulating agents (ESAs', 'HD with MCO dialyzer', 'medium cut-off (MCO) dialyzer', 'MCO']","['reduction ratio of hepcidin and serum levels of erythropoietin, erythroferrone, soluble transferrin receptor and hepcidin', 'TNF-α level', 'changes of erythropoietin resistance index (ERI; U/kg/wk/g/dL', 'TNF-α and lower serum', 'ESA dose, weight-adjusted ESA dose, and ERI', 'iron metabolism', 'ESA resistance', 'Serum iron and transferrin saturation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1300561', 'cui_str': 'U/kg'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}]",49.0,0.0240456,"TNF-α level at 12 weeks compared to the high-flux group (p < 0.05), whereas no differences were found in the reduction ratio of hepcidin and serum levels of erythropoietin, erythroferrone, soluble transferrin receptor and hepcidin between groups.","[{'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Jeon', 'Affiliation': 'Department of Statistics, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Ju-Min', 'Initials': 'JM', 'LastName': 'Yook', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Soon-Youn', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Hee-Yeon', 'Initials': 'HY', 'LastName': 'Jung', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Sun-Hee', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Chan-Duck', 'Initials': 'CD', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Yong-Lim', 'Initials': 'YL', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Jang-Hee', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea. jh-cho@knu.ac.kr.'}]",Scientific reports,['10.1038/s41598-020-73124-x']
3015,32998221,Evaluation of Root-End Preparation with Two Different Endodontic Microsurgery Ultrasonic Tips.,"The aim of this study is to compare root-end preparation performed with two different ultrasonic tips-CVDentus and NSK-and respective time requirements. After root-end resection, 32 teeth were randomly divided in two groups, according to the ultrasonic tip used for root-end preparation. Preparation time was recorded. Photomicrographs were taken to assess the following parameters: root surface microcracking, marginal integrity and presence of debris. One ultrasonic tip from each group was analyzed through scanning electron microscopy before and after root-end preparation. The significance level was set at α = 0.05. Incidence of microcracks in both groups was 12.5%. Solely intracanal microcracking was found, consistently positioned within the widest side of the remaining dentine. No statistically significant differences were verified between both experimental groups regarding marginal integrity ( p = 0.102) and preparation time ( p = 0.780), whereas statistical differences ( p = 0.003) were found concerning the presence of debris (the minimum registered score was mostly verified in CVDentus group). NSK tips showed major morphological changes, with extensive surface wear and noticeable loss of particles, which was not verified on CVDentus tips. Our findings suggest significant differences regarding root-end preparation walls quality, with CVDentus tips showing better results. Concerning microcracking, as well as preparation time and marginal integrity, both ultrasonic tips showed similar results. Qualitative analysis exposed NSK tips major morphological changes and wear after use, which was not verified on CVDentus tips.",2020,"No statistically significant differences were verified between both experimental groups regarding marginal integrity ( p = 0.102) and preparation time ( p = 0.780), whereas statistical differences ( p = 0.003) were found concerning the presence of debris (the minimum registered score was mostly verified in CVDentus group).",[],['ultrasonic tips-CVDentus and NSK-and respective time requirements'],"['preparation time', 'Incidence of microcracks', 'marginal integrity']",[],"[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205266', 'cui_str': 'Intact'}]",32.0,0.0170176,"No statistically significant differences were verified between both experimental groups regarding marginal integrity ( p = 0.102) and preparation time ( p = 0.780), whereas statistical differences ( p = 0.003) were found concerning the presence of debris (the minimum registered score was mostly verified in CVDentus group).","[{'ForeName': 'Paulo J', 'Initials': 'PJ', 'LastName': 'Palma', 'Affiliation': 'Institute of Endodontics, Faculty of Medicine, University of Coimbra, 3000-075 Coimbra, Portugal.'}, {'ForeName': 'Joana A', 'Initials': 'JA', 'LastName': 'Marques', 'Affiliation': 'Institute of Endodontics, Faculty of Medicine, University of Coimbra, 3000-075 Coimbra, Portugal.'}, {'ForeName': 'Margarida', 'Initials': 'M', 'LastName': 'Casau', 'Affiliation': 'Dentistry Department, Faculty of Medicine, University of Coimbra, 3000-075 Coimbra, Portugal.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Santos', 'Affiliation': 'Dentistry Department, Faculty of Medicine, University of Coimbra, 3000-075 Coimbra, Portugal.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Caramelo', 'Affiliation': 'Coimbra Institute for Clinical and Biomedical Research (iCBR), Laboratory of Biostatistics and Medical Informatics (LBIM), Faculty of Medicine, University of Coimbra, 3000-548 Coimbra, Portugal.'}, {'ForeName': 'Rui I', 'Initials': 'RI', 'LastName': 'Falacho', 'Affiliation': 'Institute of Oral Implantology and Prosthodontics, Faculty of Medicine, University of Coimbra, 3000-075 Coimbra, Portugal.'}, {'ForeName': 'João Miguel', 'Initials': 'JM', 'LastName': 'Santos', 'Affiliation': 'Institute of Endodontics, Faculty of Medicine, University of Coimbra, 3000-075 Coimbra, Portugal.'}]",Biomedicines,['10.3390/biomedicines8100383']
3016,32998321,Feasibility of a 12 Week Physical Intervention to Prevent Cognitive Decline and Disability in the At-Risk Elderly Population in Korea.,"There is a need for measures that can prevent the onset of dementia in the rapidly aging population. Reportedly, sustained physical exercise can prevent cognitive decline and disability. This study aimed to assess the feasibility of a 12-week physical exercise intervention (PEI) for delay of cognitive decline and disability in the at-risk elderly population in Korea. Twenty-six participants (aged 67.9 ± 3.6 years, 84.6% female) at risk of dementia were assigned to facility-based PEI ( n = 15) or home-based PEI ( n = 11). The PEI program consisted of muscle strength training, aerobic exercise, balance, and stretching using portable aids. Feasibility was assessed by retention and adherence rates. Physical fitness/cognitive function were compared before and after the PEI. Retention and adherence rates were 86.7% and 88.3%, respectively, for facility-based PEI and 81.8% and 62.3% for home-based PEI. No intervention-related adverse events were reported. Leg strength/endurance and cardiopulmonary endurance were improved in both groups: 30 s sit-to-stand test (facility-based, p = 0.002; home-based, p = 0.002) and 2 -min stationary march (facility-based, p = 0.001; home-based, p = 0.022). Cognitive function was improved only after facility-based PEI (Alzheimer's Disease Assessment Scale-cognitive total score, p = 0.009; story memory test on Literacy Independent Cognitive Assessment, p = 0.026). We found that, whereas our PEI is feasible, the home-based program needs supplementation to improve adherence.",2020,Leg strength/endurance and cardiopulmonary endurance were improved in both groups:,"['in the At-Risk Elderly Population in Korea', 'at-risk elderly population in Korea', 'Twenty-six participants (aged 67.9 ± 3.6 years, 84.6% female) at risk of dementia were assigned to facility-based PEI ( n = 15) or home-based PEI ( n = 11']","['muscle strength training, aerobic exercise, balance, and stretching using portable aids', 'physical exercise intervention (PEI', '12 Week Physical Intervention', 'sustained physical exercise']","['cognitive decline and disability', 'Physical fitness/cognitive function', 'Leg strength/endurance and cardiopulmonary endurance', 'Retention and adherence rates', 'adverse events', 'Cognitive function', ""facility-based PEI (Alzheimer's Disease Assessment Scale-cognitive total score"", 'retention and adherence rates', 'Cognitive Decline and Disability']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3697373', 'cui_str': 'At risk of dementia'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",26.0,0.0216671,Leg strength/endurance and cardiopulmonary endurance were improved in both groups:,"[{'ForeName': 'Sun Min', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Hong-Sun', 'Initials': 'HS', 'LastName': 'Song', 'Affiliation': 'Department of Sports Science, Korea Institute of Sport Science, Seoul 01794, Korea.'}, {'ForeName': 'Buong-O', 'Initials': 'BO', 'LastName': 'Chun', 'Affiliation': 'Department of Sports Science, Korea Institute of Sport Science, Seoul 01794, Korea.'}, {'ForeName': 'Muncheong', 'Initials': 'M', 'LastName': 'Choi', 'Affiliation': 'Exercowork, Hanam 12912, Korea.'}, {'ForeName': 'Kyunghwa', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Ki Sub', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Dongtan Public Health Center, Hwaseong 18460, Korea.'}, {'ForeName': 'Hyesu', 'Initials': 'H', 'LastName': 'Jeon', 'Affiliation': 'Department of Psychology, Ajou University, Suwon 16499, Korea.'}, {'ForeName': 'Da Eun', 'Initials': 'DE', 'LastName': 'Seo', 'Affiliation': 'Department of Psychology, Ajou University, Suwon 16499, Korea.'}, {'ForeName': 'Hye Mi', 'Initials': 'HM', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Jee Hyang', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Department of Neurology, Ewha Womans University School of medicine, Seoul 07804, Korea.'}, {'ForeName': 'Yoo Kyoung', 'Initials': 'YK', 'LastName': 'Park', 'Affiliation': 'Department of Medical Nutrition, Graduate School of East-West Medical Nutrition, Kyung Hee University, Suwon 17104, Korea.'}, {'ForeName': 'Chang Hyung', 'Initials': 'CH', 'LastName': 'Hong', 'Affiliation': 'Department of Psychiatry, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Hae Ri', 'Initials': 'HR', 'LastName': 'Na', 'Affiliation': 'Department of Neurology, Bobath Memorial Hospital, Seongnam 13552, Korea.'}, {'ForeName': 'Seong Hye', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Neurology, Inha University College of Medicine, Incheon 22212, Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Moon', 'Affiliation': 'Department of Neurology, Ajou University School of Medicine, Suwon 16499, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9103135']
3017,32998324,Clinical Effects of Dietary Supplementation of Lutein with High Bio-Accessibility on Macular Pigment Optical Density and Contrast Sensitivity: A Randomized Double-Blind Placebo-Controlled Parallel-Group Comparison Trial.,"Improvements in macular pigment optical density (MPOD) and contrast sensitivity after administration of 12 mg lutein alone and the timing at which efficacy is observed remain unknown. Therefore, lutein (12 mg), a crystalline formulation, was used in this study, considering its bioaccessibility. This study aimed to determine the effects of lutein administration for 16 weeks on MPOD, contrast sensitivity, and glare sensitivity, and changes in serum lutein levels were determined. The study subjects comprised 59 healthy male and female adults aged 20-69 years. The study diet included a placebo (placebo group) or a diet supplemented with 12 mg of lutein (lutein group). Each study diet was continuously administered for 16 weeks. At weeks 8 and 16, MPOD, contrast sensitivity, glare sensitivity, and serum lutein levels were evaluated. Compared with the placebo group, the lutein group showed significantly improved MPOD, contrast sensitivity, and glare sensitivity at week 16 and significantly increased serum lutein levels at weeks 8 and 16. Continuous administration of lutein for 16 weeks, considering its bioaccessibility, increased MPOD; it made the outlines of visible objects clearer and was effective in inhibiting decreases in visual function caused by glare from light.",2020,"Compared with the placebo group, the lutein group showed significantly improved MPOD, contrast sensitivity, and glare sensitivity at week 16 and significantly increased serum lutein levels at weeks 8 and 16.",['59 healthy male and female adults aged 20-69 years'],"['Dietary Supplementation of Lutein with High Bio-Accessibility', 'placebo (placebo', 'lutein', 'diet supplemented with 12 mg of lutein (lutein group', 'placebo', 'Placebo']","['Macular Pigment Optical Density and Contrast Sensitivity', 'MPOD', 'MPOD, contrast sensitivity, and glare sensitivity', 'MPOD, contrast sensitivity, and glare sensitivity, and changes in serum lutein levels', 'visual function', 'serum lutein levels', 'macular pigment optical density (MPOD) and contrast sensitivity', 'MPOD, contrast sensitivity, glare sensitivity, and serum lutein levels']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0278215', 'cui_str': 'Glare'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",59.0,0.172558,"Compared with the placebo group, the lutein group showed significantly improved MPOD, contrast sensitivity, and glare sensitivity at week 16 and significantly increased serum lutein levels at weeks 8 and 16.","[{'ForeName': 'Naomichi', 'Initials': 'N', 'LastName': 'Machida', 'Affiliation': 'Omnica Co., Ltd. TN Koshikawa Building 5th floor 4--21-7 Itabashi, Itabashiku, Tokyo 173-0004, Japan.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Kosehira', 'Affiliation': 'Graduate School of Pharmaceutical Sciences, Josai University, 1-1 Keyakidai, Sakado-city, Saitama 350-0295, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Kitaichi', 'Affiliation': 'Department of Ophthalmology, Health Sciences University of Hokkaido, 1757 Kanazawa, Tobetsu-cho, Ishikari-gun, Hokkaido 061-0293, Japan.'}]",Nutrients,['10.3390/nu12102966']
3018,33012118,Cost-Effectiveness of a Novel Sleep Intervention in Infancy to Prevent Overweight in Childhood.,"OBJECTIVE
The purpose of this study was to determine, from a health funder perspective, whether a sleep intervention, delivered in infancy, either alone or in combination with food, activity, and breastfeeding advice was cost-effective compared with usual care.
METHODS
A cost-effectiveness analysis was conducted alongside the Prevention of Overweight in Infancy (POI) randomized controlled trial for outcomes at 5 years and cost-effectiveness was modeled to age 15 years using the Early Prevention of Obesity in Childhood microsimulation model. Intervention costs for the Sleep (n = 192), Combination (n = 196), and control (n = 209) groups were determined in 2018 Australian dollars. Incremental cost-effectiveness ratios (ICERs) were determined for BMI outcomes at 5 and 15 years, with the primary outcome being quality-adjusted life years (QALYs) modeled over 15 years.
RESULTS
The average costs of the Sleep and Combination interventions were $184 and $601 per child, respectively. The ICER for the Sleep intervention was $18,125 per QALY gained, with a 74% probability of being cost-effective at a willingness-to-pay threshold of $50,000 per QALY. The ICER for the Combination intervention was $94,667 per QALY gained with a 23% probability of being cost-effective.
CONCLUSIONS
The POI Sleep intervention, without additional advice, was a low-cost and cost-effective approach to reducing childhood obesity. Sleep modification programs offer a very promising approach to obesity prevention in children.",2020,"The POI Sleep intervention, without additional advice, was a low-cost and cost-effective approach to reducing childhood obesity.","['children', 'age 15 years using the Early Prevention of Obesity in Childhood microsimulation model', 'Infancy to Prevent Overweight in Childhood']",['Novel Sleep Intervention'],"['average costs of the Sleep and Combination interventions', 'Cost-Effectiveness', 'Incremental cost-effectiveness ratios (ICERs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C4521075', 'cui_str': 'Overweight in childhood'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0394979,"The POI Sleep intervention, without additional advice, was a low-cost and cost-effective approach to reducing childhood obesity.","[{'ForeName': 'Eng Joo', 'Initials': 'EJ', 'LastName': 'Tan', 'Affiliation': 'Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachael W', 'Initials': 'RW', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Barry J', 'Initials': 'BJ', 'LastName': 'Taylor', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Brown', 'Affiliation': 'Deakin Health Economics, Institute for Health Transformation, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Hayes', 'Affiliation': 'Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22989']
3019,32998206,The Effects of Long-Term Magnesium Creatine Chelate Supplementation on Repeated Sprint Ability (RAST) in Elite Soccer Players.,"AIM
The aim of the study was to evaluate the effects of 16 weeks of a low dose of magnesium creatine chelate supplementation on repeated sprint ability test (RAST) results in elite soccer players.
MATERIALS
Twenty well-trained soccer players participated in the study. The players were divided randomly into two groups: the supplemented group (SG = 10) and placebo group (PG = 10). Out of the 20 subjects selected for the study, 16 (SG = 8, PG = 8) completed the entire experiment. The SG ingested a single dose of 5500 mg of magnesium creatine chelate (MgCr-C), in 4 capsules per day, which was 0.07 g/kg/d. The PG received an identical 4 capsules containing corn starch. Before and after the study, the RAST was performed. In the RAST, total time (TT), first and sixth 35 m sprint length (s), average power (AP) and max power (MP) were measured. Additionally, before and after the test, lactate LA (mmol/L) and acid-base equilibrium pH (-log(H + )), bicarbonates HCO 3 - (mmol/L) were evaluated. Also, in serum at rest, creatinine (mg/dL) concentration was measured.
RESULTS
After the study, significantly better results in TT, AP and MP were observed in the SG. No significant changes in the RAST results were observed in the PG. After the study, significant changes in the first 35 m sprint, as well as the sixth 35 m sprint results were registered in the SG, while insignificant changes occurred in the PG. A significantly higher creatinine concentration was observed. Also, a higher post-RAST concentration of LA, HCO 3 - and lower values of pH were observed in April, May and June compared with baseline values.
CONCLUSIONS
The long timeframe, i.e., 16 weeks, of the low dose of magnesium creatine chelate supplementation improved the RAST results in the SG. Despite the long period of MgCr-C supplementation, in the end of the study, the creatinine level in the SG reached higher but still reference values.",2020,"After the study, significantly better results in TT, AP and MP were observed in the SG.","['elite soccer players', 'Twenty well-trained soccer players participated in the study', 'Elite Soccer Players', '20 subjects selected for the study, 16 (SG = 8, PG = 8) completed the entire experiment']","['identical 4 capsules containing corn starch', 'placebo', 'magnesium creatine chelate supplementation', 'magnesium creatine chelate (MgCr-C', 'Long-Term Magnesium Creatine Chelate Supplementation']","['Repeated Sprint Ability (RAST', 'higher post-RAST concentration of LA, HCO 3 - and lower values of pH', 'serum at rest, creatinine (mg/dL) concentration', 'RAST results', 'repeated sprint ability test (RAST', 'lactate LA (mmol/L) and acid-base equilibrium pH (-log(H + )), bicarbonates HCO 3 - (mmol/L', 'TT, AP and MP', 'creatinine concentration', 'total time (TT), first and sixth 35 m sprint length (s), average power (AP) and max power (MP']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}]","[{'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0007974', 'cui_str': 'Chelating agent'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0001117', 'cui_str': 'Acid-base equilibrium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",20.0,0.0681599,"After the study, significantly better results in TT, AP and MP were observed in the SG.","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Golas', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Chycki', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Mateusz', 'Initials': 'M', 'LastName': 'Halz', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Małgorzata Magdalena', 'Initials': 'MM', 'LastName': 'Michalczyk', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}]",Nutrients,['10.3390/nu12102961']
3020,32998220,Topical Propranolol Improves Epistaxis Control in Hereditary Hemorrhagic Telangiectasia (HHT): A Randomized Double-Blind Placebo-Controlled Trial.,"Epistaxis is a common debilitating manifestation in hereditary hemorrhagic telangiectasia (HHT), due to mucocutaneous telangiectases. The epistaxis can be difficult to control despite available treatments. Dysregulated angiogenesis has been shown to be associated with telangiectases formation. Topical propranolol has demonstrated antiangiogenic properties. We performed a two-phase study, i.e., a double-blind placebo-controlled phase, followed by an open-label phase. The aim of the study was assessment of safety and efficacy of nasal propranolol gel in HHT-related epistaxis. Twenty participants with moderate-severe HHT-related epistaxis were randomized to eight weeks of propranolol gel 1.5%, or placebo 0.5 cc, applied to each nostril twice daily; and continued propranolol for eight weeks in an open-label study. For the propranolol group, the epistaxis severity score (ESS) improved significantly (-2.03 ± 1.7 as compared with -0.35 ± 0.68 for the placebo group, p = 0.009); hemoglobin levels improved significantly (10.5 ± 2.6 to 11.4 ± 2.02 g/dL, p = 0.009); and intravenous iron and blood transfusion requirement decreased. The change in nasal endoscopy findings was not significant. During the open-label period, the ESS score improved significantly in the former placebo group (-1.99 ± 1.41, p = 0.005). The most common adverse event was nasal mucosa burning sensation. No cardiovascular events were reported. Our results suggest that topical propranolol gel is safe and effective in HHT-related epistaxis.",2020,"For the propranolol group, the epistaxis severity score (ESS) improved significantly (-2.03 ± 1.7 as compared with -0.35 ± 0.68 for the placebo group, p = 0.009); hemoglobin levels improved significantly (10.5 ± 2.6 to 11.4 ± 2.02 g/dL, p = 0.009); and intravenous iron and blood transfusion requirement decreased.","['Twenty participants with moderate-severe HHT-related epistaxis', 'HHT-related epistaxis', 'Hereditary Hemorrhagic Telangiectasia (HHT']","['Topical propranolol', 'propranolol', 'Topical Propranolol', 'placebo', 'topical propranolol gel', 'nasal propranolol gel', 'Placebo', 'propranolol gel 1.5%, or placebo 0.5 cc, applied to each nostril twice daily; and continued propranolol']","['epistaxis severity score (ESS', 'hemoglobin levels', 'intravenous iron and blood transfusion requirement', 'safety and efficacy', 'nasal endoscopy findings', 'ESS score', 'cardiovascular events']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0039445', 'cui_str': 'Osler hemorrhagic telangiectasia syndrome'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",20.0,0.216774,"For the propranolol group, the epistaxis severity score (ESS) improved significantly (-2.03 ± 1.7 as compared with -0.35 ± 0.68 for the placebo group, p = 0.009); hemoglobin levels improved significantly (10.5 ± 2.6 to 11.4 ± 2.02 g/dL, p = 0.009); and intravenous iron and blood transfusion requirement decreased.","[{'ForeName': 'Meir', 'Initials': 'M', 'LastName': 'Mei-Zahav', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva 49202, Israel.""}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Gendler', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva 49202, Israel.""}, {'ForeName': 'Elchanan', 'Initials': 'E', 'LastName': 'Bruckheimer', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 69978, Israel.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Prais', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva 49202, Israel.""}, {'ForeName': 'Einat', 'Initials': 'E', 'LastName': 'Birk', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 69978, Israel.'}, {'ForeName': 'Muhamad', 'Initials': 'M', 'LastName': 'Watad', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 69978, Israel.'}, {'ForeName': 'Neta', 'Initials': 'N', 'LastName': 'Goldschmidt', 'Affiliation': 'Department of Hematology, Hadassah-Hebrew University Medical Center, Jerusalem 91120, Israel.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Soudry', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 69978, Israel.'}]",Journal of clinical medicine,['10.3390/jcm9103130']
3021,32998018,Glycemic qualification rate and frequency of self-monitoring blood glucose glycemic qualification rate and frequency of self-monitoring blood glucose (SMBG) in women with gestational diabetes mellitus (GDM).,"AIMS
To explore the relationship between blood glucose (BG) control rate and self-monitoring blood glucose (SMBG) compliance of women with gestational diabetes mellitus (GDM).
METHODS
Women with GDM (n = 309) were randomized to receive routine clinical prenatal care or additional online management. Follow-up visits were conducted every two weeks (noted here as T) from enrollment to delivery. SMBG records were used for the analysis.
RESULTS
Both the intervention group and the control group had an increasing BG control rate and decreasing SMBG compliance during the whole follow-up period. Detailed data analysis on separate follow-up periods showed that the SMBG frequency was negatively correlated with the BG control rate in most Ts and that the BG control rate of T n-1 was negatively correlated with the SMBG frequency of T n in the adjacent T. Only in the intervention group was T 2 SMBG compliance not under the influence of the T 1 BG control rate.
CONCLUSIONS
Our data suggested that regardless of management approach, the BG control rate increased, and the SMBG frequency decreased as gestational weeks increased in women with GDM. Even in separate follow-up periods, the SMBG frequency was negatively correlated with the BG control rate both within one follow-up period and between two adjacent follow-up periods.",2020,Both the intervention group and the control group had an increasing BG control rate and decreasing SMBG compliance during the whole follow-up period.,"['Women with GDM (n=309', 'women with GDM', 'women with gestational diabetes mellitus (GDM']",['routine clinical prenatal care or additional online management'],"['BG control rate and decreasing SMBG compliance', 'Glycemic qualification rate and frequency of self-monitoring blood glucose Glycemic qualification rate and frequency of self-monitoring blood glucose (SMBG', 'blood glucose (BG) control rate and self-monitoring blood glucose (SMBG) compliance', 'BG control rate', 'SMBG frequency of Tn', 'SMBG frequency']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",309.0,0.0292636,Both the intervention group and the control group had an increasing BG control rate and decreasing SMBG compliance during the whole follow-up period.,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Suhan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Feiling', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Fenglian', 'Initials': 'F', 'LastName': 'Shi', 'Affiliation': 'Zhengzhou Central Hospital Affiliated to Zhengzhou University, No. 16 Tongbai North Road, Zhongyuan District, Zhengzhou, Henan Province 450007, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Shenyang Maternity and Child Health Hospital, No. 41 Shenzhou Road, Shenhe District, Shenyang, Liaoning Province 110000, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""QuanZhou Women's and Children's Hospital, No. 700 Fengze Street, Quanzhou, Fujian Province 362000, China.""}, {'ForeName': 'Chuci', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Shenyang Women's and Children's Hospital, No. 87 Danan Street, Shenhe District, Shenyang, Liaoning Province 110011, China.""}, {'ForeName': 'Hongxiu', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Xiamen Maternal and Child Health Hospital, No. 10 Zhenhai Road, Xiamen, Fujian Province 361003, China.'}, {'ForeName': 'Weibo', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': ""Shunyi Women's & Children's Hospital of Beijing Children's Hospital, No. 1 Shunkang Road, Shunyi District, Beijing 101300, China.""}, {'ForeName': 'Cuiying', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Jinan Maternity and Child Care Hospital Affiliated to Shandong First Medical University, No. 2 Jianguoxiaojingsan Street, Shizhong District, Jinan, Shandong Province 250001, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Niu', 'Affiliation': ""Fuyang People's Hospital, No. 63 Luci Street, Yinzhou District, Fuyang, Anhui Province 236004, China.""}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': 'Beijing Pinggu Hospital, No. 59 Xinping North Road, Pinggu District, Beijing 101200, China.'}, {'ForeName': 'Liangkun', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, 100730, China. Electronic address: MaLiangKun@pumch.cn.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108482']
3022,33002429,"Timing of radiotherapy after radical prostatectomy (RADICALS-RT): a randomised, controlled phase 3 trial.","BACKGROUND
The optimal timing of radiotherapy after radical prostatectomy for prostate cancer is uncertain. We aimed to compare the efficacy and safety of adjuvant radiotherapy versus an observation policy with salvage radiotherapy for prostate-specific antigen (PSA) biochemical progression.
METHODS
We did a randomised controlled trial enrolling patients with at least one risk factor (pathological T-stage 3 or 4, Gleason score of 7-10, positive margins, or preoperative PSA ≥10 ng/mL) for biochemical progression after radical prostatectomy (RADICALS-RT). The study took place in trial-accredited centres in Canada, Denmark, Ireland, and the UK. Patients were randomly assigned in a 1:1 ratio to adjuvant radiotherapy or an observation policy with salvage radiotherapy for PSA biochemical progression (PSA ≥0·1 ng/mL or three consecutive rises). Masking was not deemed feasible. Stratification factors were Gleason score, margin status, planned radiotherapy schedule (52·5 Gy in 20 fractions or 66 Gy in 33 fractions), and centre. The primary outcome measure was freedom from distant metastases, designed with 80% power to detect an improvement from 90% with salvage radiotherapy (control) to 95% at 10 years with adjuvant radiotherapy. We report on biochemical progression-free survival, freedom from non-protocol hormone therapy, safety, and patient-reported outcomes. Standard survival analysis methods were used. A hazard ratio (HR) of less than 1 favoured adjuvant radiotherapy. This study is registered with ClinicalTrials.gov, NCT00541047.
FINDINGS
Between Nov 22, 2007, and Dec 30, 2016, 1396 patients were randomly assigned, 699 (50%) to salvage radiotherapy and 697 (50%) to adjuvant radiotherapy. Allocated groups were balanced with a median age of 65 years (IQR 60-68). Median follow-up was 4·9 years (IQR 3·0-6·1). 649 (93%) of 697 participants in the adjuvant radiotherapy group reported radiotherapy within 6 months; 228 (33%) of 699 in the salvage radiotherapy group reported radiotherapy within 8 years after randomisation. With 169 events, 5-year biochemical progression-free survival was 85% for those in the adjuvant radiotherapy group and 88% for those in the salvage radiotherapy group (HR 1·10, 95% CI 0·81-1·49; p=0·56). Freedom from non-protocol hormone therapy at 5 years was 93% for those in the adjuvant radiotherapy group versus 92% for those in the salvage radiotherapy group (HR 0·88, 95% CI 0·58-1·33; p=0·53). Self-reported urinary incontinence was worse at 1 year for those in the adjuvant radiotherapy group (mean score 4·8 vs 4·0; p=0·0023). Grade 3-4 urethral stricture within 2 years was reported in 6% of individuals in the adjuvant radiotherapy group versus 4% in the salvage radiotherapy group (p=0·020).
INTERPRETATION
These initial results do not support routine administration of adjuvant radiotherapy after radical prostatectomy. Adjuvant radiotherapy increases the risk of urinary morbidity. An observation policy with salvage radiotherapy for PSA biochemical progression should be the current standard after radical prostatectomy.
FUNDING
Cancer Research UK, MRC Clinical Trials Unit, and Canadian Cancer Society.",2020,Self-reported urinary incontinence was worse at 1 year for those in the adjuvant radiotherapy group (mean score 4·8 vs 4·0; p=0·0023).,"['697 participants in the', 'Between Nov 22, 2007, and Dec 30, 2016, 1396 patients were randomly assigned, 699 (50%) to', 'patients with at least one risk factor (pathological T-stage 3 or 4, Gleason score of 7-10, positive margins, or preoperative PSA ≥10 ng/mL) for biochemical progression after radical prostatectomy (RADICALS-RT', '649']","['adjuvant radiotherapy or an observation policy with salvage radiotherapy', 'adjuvant radiotherapy', 'Adjuvant radiotherapy', 'radiotherapy after radical prostatectomy (RADICALS-RT', 'salvage radiotherapy', 'radiotherapy']","['freedom from distant metastases', 'Grade 3-4 urethral stricture', 'efficacy and safety', 'Self-reported urinary incontinence', '5-year biochemical progression-free survival', 'risk of urinary morbidity']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0475455', 'cui_str': 'T - Tumor stage'}, {'cui': 'C0332326', 'cui_str': 'Gleason grading system for prostatic cancer'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}]","[{'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",1396.0,0.183777,Self-reported urinary incontinence was worse at 1 year for those in the adjuvant radiotherapy group (mean score 4·8 vs 4·0; p=0·0023).,"[{'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Parker', 'Affiliation': 'Department of Oncology, Royal Marsden NHS Foundation Trust, Sutton, UK; Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Noel W', 'Initials': 'NW', 'LastName': 'Clarke', 'Affiliation': 'Department of Oncology, Genito-Urinary Cancer Research Group, The Christie Hospital, Manchester, UK; Department of Surgery, The Christie Hospital, Manchester, UK; Department of Urology, Salford Royal Hospitals, Manchester, UK.'}, {'ForeName': 'Adrian D', 'Initials': 'AD', 'LastName': 'Cook', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Howard G', 'Initials': 'HG', 'LastName': 'Kynaston', 'Affiliation': 'Department of Urology, Cardiff University School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Peter Meidahl', 'Initials': 'PM', 'LastName': 'Petersen', 'Affiliation': 'Department of Oncology, Copenhagen Prostate Cancer Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Catton', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Hospital, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Cross', 'Affiliation': ""Department Of Urology, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Logue', 'Affiliation': 'Department of Oncology, The Christie Hospital, Manchester, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Parulekar', 'Affiliation': ""Department of Oncology, Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Payne', 'Affiliation': 'Department of Oncology, University College London Hospitals, London, UK.'}, {'ForeName': 'Rajendra', 'Initials': 'R', 'LastName': 'Persad', 'Affiliation': 'Department of Urology, Bristol Urological Institute, North Bristol Hospitals, Bristol, UK.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Pickering', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""Department of Urology, Centre Hospitalier de l'Université de Montreal, Montreal, QC, Canada.""}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Department of Oncology, Mid Yorkshire Hospitals NHS Trust, Wakefield, UK.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bahl', 'Affiliation': 'Department of Oncology, Bristol Cancer Institute, University Hospitals Bristol, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bottomley', 'Affiliation': ""St James's Institute of Oncology, Leeds, UK.""}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Brasso', 'Affiliation': 'Department of Urology, Copenhagen Prostate Cancer Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Chahal', 'Affiliation': 'Department of Urology, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Cooke', 'Affiliation': 'Department of Urology, The Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Eddy', 'Affiliation': 'Department of Urology, East Kent Hospitals University Foundation Trust, Canterbury, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gibbs', 'Affiliation': 'Department of Oncology, Barking, Havering and Redbridge University Hospitals NHS Trust, Romford, UK.'}, {'ForeName': 'Chee', 'Initials': 'C', 'LastName': 'Goh', 'Affiliation': 'Department of Oncology, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Gujral', 'Affiliation': 'Department of Urology, Barking, Havering and Redbridge University Hospitals NHS Trust, Romford, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Heath', 'Affiliation': 'Department of Clinical Oncology, University Hospital Southampton, Southampton, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Henderson', 'Affiliation': 'Department of Urology, Maidstone and Tunbridge Wells NHS Trust, Maidstone, UK.'}, {'ForeName': 'Ramasamy', 'Initials': 'R', 'LastName': 'Jaganathan', 'Affiliation': 'Department of Urology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Urology, Herlev University Hospital, Herlev, Denmark.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'Institute of Cancer Research, London, UK; Department of Oncology, Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Subramanian', 'Initials': 'S', 'LastName': 'Kanaga Sundaram', 'Affiliation': 'Department of Urology, Mid Yorkshire Hospitals NHS Trust, Wakefield, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Lees', 'Affiliation': 'Kent Oncology Centre, Maidstone Hospital, Kent, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lester', 'Affiliation': 'Department of Oncology, South West Wales Cancer Centre, Swansea, UK.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Lindberg', 'Affiliation': 'Department of Oncology, Herlev University Hospital, Herlev, Denmark.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Money-Kyrle', 'Affiliation': 'Department of Oncology, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'Department of Clinical Oncology, Guys Hospital, London, UK.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': ""O'Sullivan"", 'Affiliation': 'Department of Clinical Oncology, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ostler', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Owen', 'Affiliation': ""Department of Oncology, Leeds Cancer Centre, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Department of Urology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Alvan', 'Initials': 'A', 'LastName': 'Pope', 'Affiliation': 'Department of Urology, Hillingdon Hospital, Middlesex, UK; Mount Vernon Hospital, Northwood, UK; Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Popert', 'Affiliation': 'Department of Urology, Guys Hospital, London, UK.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Raman', 'Affiliation': 'Department of Clinical Oncology, Kent Oncology Centre, Canterbury, UK.'}, {'ForeName': 'Martin Andreas', 'Initials': 'MA', 'LastName': 'Røder', 'Affiliation': 'Department of Urology, Copenhagen Prostate Cancer Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Sayers', 'Affiliation': 'Department of Oncology, The Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Simms', 'Affiliation': 'Department of Urology, Hull University Hospitals NHS Trust, Hull, UK.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'Department of Urology, Anuerin Bevan University Health Board, Newport, UK.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Zarkar', 'Affiliation': 'Department of Oncology, University Hospital Birmingham, Birmingham, UK.'}, {'ForeName': 'Mahesh K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK. Electronic address: m.sydes@ucl.ac.uk.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31553-1']
3023,33003338,"The Effects of a Functional Food Breakfast on Gluco-Regulation, Cognitive Performance, Mood, and Satiety in Adults.","A whole diet which combines multiple functional foods benefits metabolic risk factors and cognition, but evidence supporting meal to meal benefits, which individuals may find easier to implement, is limited. This study developed a functional food breakfast (FB), using polyphenol-rich ingredients selected for their gluco-regulating and cognitive-enhancing properties, and compared it to a control breakfast (CB). For study 1, total polyphenols were determined using the Folin-Ciocalteu method, and sugar release by in vitro digestion, in frozen and fresh samples. In study 2, healthy adults ( n = 16) consumed an FB, CB and ready-to-eat breakfast cereal (RTEC) in a randomised crossover design. Glucose (GR) and insulin response (IR), satiety, mood and memory were measured over 180 min. The FB was a rich source of polyphenols (230 mg) compared to the CB (147 mg) ( p < 0.05), and using frozen muffins did not compromise the polyphenol content or sugar release. Peak GR was highest after the RTEC ( p < 0.05), and the insulin area under the curve (AUC) was lowest in the FB at 60, 120, 180 min and peak ( p < 0.05). There were no effects on GR AUC, mood, satiety or memory. Reductions in GR peak and IR following consumption of the FB support the inclusion of functional ingredients at breakfast.",2020,"Peak GR was highest after the RTEC ( p < 0.05), and the insulin area under the curve (AUC) was lowest in the FB at 60, 120, 180 min and peak ( p < 0.05).","['Adults', 'healthy adults ( n = 16) consumed an']","['Functional Food Breakfast', 'FB, CB and ready-to-eat breakfast cereal (RTEC', 'functional food breakfast (FB']","['insulin area under the curve (AUC', 'Peak GR', 'Glucose (GR) and insulin response (IR), satiety, mood and memory', 'Gluco-Regulation, Cognitive Performance, Mood, and Satiety', 'GR AUC, mood, satiety or memory', 'polyphenol content or sugar release']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C2717755', 'cui_str': 'Functional Food'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",,0.0331968,"Peak GR was highest after the RTEC ( p < 0.05), and the insulin area under the curve (AUC) was lowest in the FB at 60, 120, 180 min and peak ( p < 0.05).","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Kennedy', 'Affiliation': 'Functional Food Centre, Oxford Brookes University, Oxford OX3 0BP, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ryan', 'Affiliation': 'School of Science and Computing, Galway-Mayo Institute of Technology, H91 T8NW Galway, Ireland.'}, {'ForeName': 'Miriam E', 'Initials': 'ME', 'LastName': 'Clegg', 'Affiliation': 'Department of Food and Nutritional Sciences, University of Reading, Reading RG6 6DZ, UK.'}]",Nutrients,['10.3390/nu12102974']
3024,33003389,Obese Older Type 2 Diabetes Mellitus Patients with Muscle Insulin Resistance Benefit from an Enriched Protein Drink during Combined Lifestyle Intervention: The PROBE Study.,"(1) Background: Recent research showed that subtypes of patients with type 2 diabetes may differ in response to lifestyle interventions based on their organ-specific insulin resistance (IR). (2) Methods: 123 Subjects with type 2 diabetes were randomized into 13-week lifestyle intervention, receiving either an enriched protein drink (protein+) or an isocaloric control drink (control). Before and after the intervention, anthropometrical and physiological data was collected. An oral glucose tolerance test was used to calculate indices representing organ insulin resistance (muscle, liver, and adipose tissue) and β-cell functioning. In 82 study-compliant subjects (per-protocol), we retrospectively examined the intervention effect in patients with muscle IR (MIR, n = 42) and without MIR (no-MIR, n = 40). (3) Results: Only in patients from the MIR subgroup that received protein + drink, fasting plasma glucose and insulin, whole body, liver and adipose IR, and appendicular skeletal muscle mass improved versus control. Lifestyle intervention improved body weight and fat mass in both subgroups. Furthermore, for the MIR subgroup decreased systolic blood pressure and increased VO 2 peak and for the no-MIR subgroup, a decreased 2-h glucose concentration was found. (4) Conclusions: Enriched protein drink during combined lifestyle intervention seems to be especially effective on increasing muscle mass and improving insulin resistance in obese older, type 2 diabetes patients with muscle IR.",2020,"whole body, liver and adipose IR, and appendicular skeletal muscle mass improved versus control.","['patients with muscle IR (MIR, n = 42) and without MIR (no-MIR, n = 40', 'obese older, type 2 diabetes patients with muscle IR', 'Obese Older Type 2 Diabetes Mellitus Patients with Muscle Insulin Resistance Benefit from an Enriched', '123 Subjects with type 2 diabetes']","['Protein Drink during Combined Lifestyle Intervention', 'Lifestyle intervention', 'lifestyle intervention, receiving either an enriched protein drink (protein+) or an isocaloric control drink (control']","['2-h glucose concentration', 'systolic blood pressure', 'body weight and fat mass', 'fasting plasma glucose and insulin', 'organ insulin resistance (muscle, liver, and adipose tissue) and β-cell functioning', 'whole body, liver and adipose IR, and appendicular skeletal muscle mass']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]",123.0,0.0183175,"whole body, liver and adipose IR, and appendicular skeletal muscle mass improved versus control.","[{'ForeName': 'Wilrike J', 'Initials': 'WJ', 'LastName': 'Pasman', 'Affiliation': 'Netherlands Organisation for Applied Scientific Research (TNO), 3704 HE Zeist, The Netherlands.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Memelink', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, 1067 SM Amsterdam, The Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'de Vogel-Van den Bosch', 'Affiliation': 'Danone Nutricia Research, 3584 CT Utrecht, The Netherlands.'}, {'ForeName': 'Mark P V', 'Initials': 'MPV', 'LastName': 'Begieneman', 'Affiliation': 'Netherlands Organisation for Applied Scientific Research (TNO), 3704 HE Zeist, The Netherlands.'}, {'ForeName': 'Willem J', 'Initials': 'WJ', 'LastName': 'van den Brink', 'Affiliation': 'Netherlands Organisation for Applied Scientific Research (TNO), 3704 HE Zeist, The Netherlands.'}, {'ForeName': 'Peter J M', 'Initials': 'PJM', 'LastName': 'Weijs', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, 1067 SM Amsterdam, The Netherlands.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Wopereis', 'Affiliation': 'Netherlands Organisation for Applied Scientific Research (TNO), 3704 HE Zeist, The Netherlands.'}]",Nutrients,['10.3390/nu12102979']
3025,33003436,Hospitalization for Acute Respiratory Tract Infection in a Low-Antibiotic-Prescribing Setting: Cross-Sectional Data from General Practice.,"BACKGROUND
Acute respiratory tract infections (ARTI) are the main cause of inappropriate antibiotic prescribing. To date, there is limited evidence concerning whether low levels of antibiotic prescribing may impact patient safety. We investigate whether antibiotic prescribing for patients seeking primary care for ARTI correlates with the odds for hospitalization.
METHODS
Analysis of patient baseline data ( n = 3669) within a cluster-randomized controlled trial. Adult patients suffering from ARTI in German primary care are included. The main outcome measure is acute hospitalization for respiratory infection and for any acute disease from 0 to 42 days after initial consultation.
RESULTS
Neither the antibiotic status of individual patients (OR 0.91; 95% CI: 0.49 to 1.69; p -value = 0.769) nor the physician-specific antibiotic prescription rates for ARTI (OR 1.22; 95% CI: 1.00 to 1.49; p -value = 0.054) had a significant effect on hospitalization. The following factors increased the odds for hospitalization: patient's age, the ARTI being defined as lower respiratory tract infections (such as bronchitis) by the physician, the physician's perception of disease severity, and being cared for within group practices (versus treated in single-handed practices).
CONCLUSIONS
In a low-antibiotic-prescribing primary care setting such as Germany, lack of treatment with antibiotics for ARTI did not result in higher odds for hospitalization in an adult population.",2020,"The following factors increased the odds for hospitalization: patient's age, the ARTI being defined as lower respiratory tract infections (such as bronchitis) by the physician, the physician's perception of disease severity, and being cared for within group practices (versus treated in single-handed practices).
","['Adult patients suffering from ARTI in German primary care', 'Analysis of patient baseline data ( n = 3669) within a cluster-randomized controlled trial', 'patients seeking primary care for ARTI correlates with the odds for hospitalization']",['antibiotic prescribing'],"['hospitalization', 'acute hospitalization for respiratory infection and for any acute disease', 'physician-specific antibiotic prescription rates for ARTI']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4759838', 'cui_str': 'Acute respiratory tract infection'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0001314', 'cui_str': 'Acute disease'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C4759838', 'cui_str': 'Acute respiratory tract infection'}]",,0.0829148,"The following factors increased the odds for hospitalization: patient's age, the ARTI being defined as lower respiratory tract infections (such as bronchitis) by the physician, the physician's perception of disease severity, and being cared for within group practices (versus treated in single-handed practices).
","[{'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Löffler', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, 18057 Rostock, Germany.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Altiner', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, 18057 Rostock, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Diener', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, 18057 Rostock, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Berner', 'Affiliation': 'Department of Pediatrics, University Hospital Carl Gustav Carus, TU, 01307 Dresden, Germany.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Feldmeier', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, 18057 Rostock, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Helbig', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, 18057 Rostock, Germany.'}, {'ForeName': 'Winfried V', 'Initials': 'WV', 'LastName': 'Kern', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Medical Center, University of Freiburg, 79085 Freiburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Köchling', 'Affiliation': 'Clinic of Psychosomatic Medicine and Psychotherapy, Rostock University Medical Center, 18057 Rostock, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Schmid', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Medical Center, University of Freiburg, 79085 Freiburg, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schön', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, 20251 Hamburg, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schröder', 'Affiliation': 'AOK Research Institute (WIdO), 10178 Berlin, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, 20251 Hamburg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Wollny', 'Affiliation': 'Institute of General Practice, Rostock University Medical Center, 18057 Rostock, Germany.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9100653']
3026,33003524,"Accuracy of the Dexcom G6 Glucose Sensor during Aerobic, Resistance, and Interval Exercise in Adults with Type 1 Diabetes.","The accuracy of continuous glucose monitoring (CGM) sensors may be significantly impacted by exercise. We evaluated the impact of three different types of exercise on the accuracy of the Dexcom G6 sensor. Twenty-four adults with type 1 diabetes on multiple daily injections wore a G6 sensor. Participants were randomized to aerobic, resistance, or high intensity interval training (HIIT) exercise. Each participant completed two in-clinic 30-min exercise sessions. The sensors were applied on average 5.3 days prior to the in-clinic visits (range 0.6-9.9). Capillary blood glucose (CBG) measurements with a Contour Next meter were performed before and after exercise as well as every 10 min during exercise. No CGM calibrations were performed. The median absolute relative difference (MARD) and median relative difference (MRD) of the CGM as compared with the reference CBG did not differ significantly from the start of exercise to the end exercise across all exercise types (ranges for aerobic MARD: 8.9 to 13.9% and MRD: -6.4 to 0.5%, resistance MARD: 7.7 to 14.5% and MRD: -8.3 to -2.9%, HIIT MARD: 12.1 to 16.8% and MRD: -14.3 to -9.1%). The accuracy of the no-calibration Dexcom G6 CGM was not significantly impacted by aerobic, resistance, or HIIT exercise.",2020,"The accuracy of the no-calibration Dexcom G6 CGM was not significantly impacted by aerobic, resistance, or HIIT exercise.","['Twenty-four adults with type 1 diabetes on multiple daily injections wore a G6 sensor', 'Adults with Type 1 Diabetes']","['aerobic, resistance, or high intensity interval training (HIIT) exercise']","['accuracy of continuous glucose monitoring (CGM) sensors', 'median absolute relative difference (MARD) and median relative difference (MRD', 'Capillary blood glucose (CBG) measurements']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",24.0,0.0233425,"The accuracy of the no-calibration Dexcom G6 CGM was not significantly impacted by aerobic, resistance, or HIIT exercise.","[{'ForeName': 'Florian H', 'Initials': 'FH', 'LastName': 'Guillot', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Jacobs', 'Affiliation': 'Artificial Intelligence for Medical Systems Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Wilson', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Joseph El', 'Initials': 'JE', 'LastName': 'Youssef', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Virginia B', 'Initials': 'VB', 'LastName': 'Gabo', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Branigan', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Nichole S', 'Initials': 'NS', 'LastName': 'Tyler', 'Affiliation': 'Artificial Intelligence for Medical Systems Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Ramsey', 'Affiliation': 'Oregon Clinical and Translational Research Institute Biostatistics & Design Program, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Riddell', 'Affiliation': 'Muscle Health Research Centre, School of Kinesiology and Health Science, York University, Toronto, ON M3J 1P3, Canada.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Castle', 'Affiliation': 'Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR 97239, USA.'}]",Biosensors,['10.3390/bios10100138']
3027,33007285,Intravenous versus oral antibiotics for eradication of Pseudomonas aeruginosa in cystic fibrosis (TORPEDO-CF): a randomised controlled trial.,"BACKGROUND
Chronic pulmonary infection with Pseudomonas aeruginosa is one of the most important causes of mortality and morbidity in cystic fibrosis. If antibiotics are commenced promptly, infection can be eradicated. The aim of the trial was to compare the effectiveness and safety of intravenous ceftazidime and tobramycin versus oral ciprofloxacin in the eradication of P aeruginosa.
METHODS
We did a multicentre, parallel group, open-label, randomised controlled trial in 72 cystic fibrosis centres (70 in the UK and two in Italy). Eligible participants were older than 28 days with an isolate of P aeruginosa (either the first ever isolate or a new isolate after at least 1 year free of infection). Participants were excluded if the P aeruginosa was resistant to, or they had a contraindication to, one or more of the trial antibiotics; if they were already receiving P aeruginosa suppressive therapy; if they had received any P aeruginosa eradication therapy within the previous 9 months; or if they were pregnant or breastfeeding. We used web-based randomisation to assign patients to 14 days intravenous ceftazidime and tobramycin or 12 weeks oral ciprofloxacin. Both were combined with 12 weeks inhaled colistimethate sodium. Randomisation lists were generated by a statistician, who had no involvement in the trial, using a computer-generated list. Randomisation was stratified by centre and because of the nature of the interventions, blinding was not possible. Our primary outcome was eradication of P aeruginosa at 3 months and remaining free of infection to 15 months. Primary analysis used intention to treat (powered for superiority). Safety analysis included patients who received at least one dose of study drug. TORPEDO-CF was registered on the ISRCTN register, ISRCTN02734162, and EudraCT, 2009-012575-10.
FINDINGS
Between Oct 5, 2010, and Jan 27, 2017, 286 patients were randomly assigned to treatment: 137 to intravenous antibiotics and 149 to oral antibiotics. 55 (44%) of 125 participants in the intravenous group and 68 (52%) of 130 participants in the oral group achieved the primary outcome. Participants randomly assigned to the intravenous group were less likely to achieve the primary outcome, although the difference between groups was not statistically significant (relative risk 0·84, 95% CI 0·65-1·09; p=0·18). 11 serious adverse events occurred in ten (8%) of 126 participants in the intravenous antibiotics group and 17 serious adverse events in 12 (8%) of 146 participants in the oral antibiotics group.
INTERPRETATION
Compared with oral therapy, intravenous antibiotics did not achieve sustained eradication of P aeruginosa in a greater proportion of patients with cystic fibrosis and was more expensive. Although there were fewer hospitalisations in the intravenous group than the oral group during follow-up, this confers no advantage over oral treatment because intravenous eradication frequently requires hospitalisation. These results do not support the use of intravenous antibiotics to eradicate P aeruginosa in cystic fibrosis.
FUNDING
National Institute for Health Research Health Technology Assessment Programme.",2020,"Compared with oral therapy, intravenous antibiotics did not achieve sustained eradication of P aeruginosa in a greater proportion of patients with cystic fibrosis and was more expensive.","['Between Oct 5, 2010, and Jan 27, 2017, 286 patients were randomly assigned to treatment', 'cystic fibrosis', 'Participants were excluded if the P aeruginosa was resistant to, or they had a contraindication to, one or more of the trial antibiotics; if they were already receiving P aeruginosa suppressive therapy; if they had received any P aeruginosa eradication therapy within the previous 9 months; or if they were pregnant or breastfeeding', 'patients who received at least one dose of study drug', '72 cystic fibrosis centres (70 in the UK and two in Italy', 'Eligible participants were older than 28 days with an isolate of P aeruginosa (either the first ever isolate or a new isolate after at least 1 year free of infection', 'cystic fibrosis (TORPEDO-CF']","['ciprofloxacin', 'ceftazidime and tobramycin', 'oral antibiotics', 'inhaled colistimethate sodium']","['serious adverse events', 'effectiveness and safety', '11 serious adverse events', 'eradication of P aeruginosa']","[{'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205367', 'cui_str': 'Suppressive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0040478', 'cui_str': 'Torpedo'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0007559', 'cui_str': 'Ceftazidime'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0110462', 'cui_str': 'Colistimethate sodium'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}]",72.0,0.164174,"Compared with oral therapy, intravenous antibiotics did not achieve sustained eradication of P aeruginosa in a greater proportion of patients with cystic fibrosis and was more expensive.","[{'ForeName': 'Simon C Langton', 'Initials': 'SCL', 'LastName': 'Hewer', 'Affiliation': 'Department of Paediatric Respiratory Medicine, Bristol Royal Hospital for Children, University of Bristol, Bristol, UK. Electronic address: UKsimon.langtonhewer@bristol.ac.uk.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Smyth', 'Affiliation': 'Division of Child Health, Obstetrics & Gynaecology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hickey', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Dervla', 'Initials': 'D', 'LastName': 'Kenna', 'Affiliation': 'Antimicrobial Resistance and Healthcare Associated Infections Reference Unit, National Infection Service, Public Health England, London, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ashby', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'The University of Manchester, Manchester Centre for Health Economics, Manchester, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30331-3']
3028,33007981,"Effects of Interval Jump Rope Exercise Combined with Dark Chocolate Supplementation on Inflammatory Adipokine, Cytokine Concentrations, and Body Composition in Obese Adolescent Boys.","We examined the effects of six weeks of dark chocolate supplementation combined with interval jump rope exercise (JRE) on inflammatory cytokines, adipokines, and body composition in obese adolescent boys. Forty-eight obese adolescent boys (age = 15.4 ± 1.1 years and body mass index = 32.2 ± 2.4 kg/m 2 ) were randomly assigned into one of four groups: JRE + white chocolate (JW; n = 13), JRE + dark chocolate supplementation (JD; n = 13), dark chocolate supplementation (DS; n = 12), or control (C; n = 12). Participants in JW and JD groups performed JRE for three times per week for six weeks. Participants in the DS and JD groups consumed 30 g of dark chocolate containing 83% of cocoa. Body composition, pro-inflammatory cytokines ((hs-CRP, TNF-α, IL-6), adipokines (leptin, resistin, RBP-4, chemerin, MCP-1), and anti-inflammatory adipokines (irisin, adiponectin)) were evaluated prior to and after the intervention trials. All three intervention trials significantly ( p < 0.05) decreased body mass, waist-hip ratio, fat mass, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, and increased irisin and adiponectin concentrations. The improvements in these parameters were greater in the JD group, and additionally, chemerin concentrations decreased only in the JD group. JD enhanced adiponectin concentrations and decreased IL-6 concentrations compared to C. Moreover, JD significantly reduced chemerin concentrations, an effect not observed in any of the other interventions. We demonstrated that dark chocolate supplementation potentiated JRE-induced decreases in body mass, WHR, FM, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, chemerin as well as increases irisin and adiponectin concentrations in obese adolescent boys. Therefore, JRE combined with dark chocolate supplementation could be a beneficial in reducing obesity-induced inflammation in adolescent boys.",2020,"All three intervention trials significantly ( p < 0.05) decreased body mass, waist-hip ratio, fat mass, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, and increased irisin and adiponectin concentrations.","['obese adolescent boys', 'Forty-eight obese adolescent boys (age\u2009 = 15.4\u2009 ± \u20091.1\u2009years and body mass index\u2009 = \u200932.2\u2009 ± \u20092.4\u2009kg/m 2 ', 'adolescent boys', 'Obese Adolescent Boys']","['dark chocolate containing 83% of cocoa', 'JRE', 'dark chocolate supplementation combined with interval jump rope exercise (JRE', 'JRE combined with dark chocolate supplementation', 'Interval Jump Rope Exercise Combined with Dark Chocolate Supplementation', 'JRE + white chocolate (JW; n = 13), JRE + dark chocolate supplementation (JD; n = 13), dark chocolate supplementation']","['Inflammatory Adipokine, Cytokine Concentrations, and Body Composition', 'body mass, WHR, FM, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, chemerin as well as increases irisin and adiponectin concentrations', 'inflammatory cytokines, adipokines, and body composition', 'Body composition, pro-inflammatory cytokines ((hs-CRP, TNF-α, IL-6), adipokines (leptin, resistin, RBP-4, chemerin, MCP-1), and anti-inflammatory adipokines (irisin, adiponectin', 'adiponectin concentrations and decreased IL-6 concentrations', 'obesity-induced inflammation', 'chemerin concentrations', 'body mass, waist-hip ratio, fat mass, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, and increased irisin and adiponectin concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517579', 'cui_str': '15.4'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517631', 'cui_str': '2.4'}]","[{'cui': 'C3853217', 'cui_str': 'Dark chocolate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0453439', 'cui_str': 'White chocolate'}]","[{'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0035342', 'cui_str': 'Retinol binding protein'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",,0.0356434,"All three intervention trials significantly ( p < 0.05) decreased body mass, waist-hip ratio, fat mass, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, and increased irisin and adiponectin concentrations.","[{'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Eskandari', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand 9717434765, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand Moghadam', 'Affiliation': 'Department of Exercise Physiology, University of Tehran, Tehran 1961733114, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan 81746-73441, Iran.'}, {'ForeName': 'Damoon', 'Initials': 'D', 'LastName': 'Ashtary-Larky', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 61357-15794, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Eskandari', 'Affiliation': 'Qaen school of Nursing and Midwifery, Birjand University of Medical Sciences, Birjand 9717853577, Iran.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nordvall', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, VA 22207, USA.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Dutheil', 'Affiliation': 'Université Clermont Auvergne, CNRS, LaPSCo, Physiological and Psychosocial Stress, CHU Clermont-Ferrand, University Hospital of Clermont-Ferrand, Preventive and Occupational Medicine, Witty Fit, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, VA 22207, USA.'}]",Nutrients,['10.3390/nu12103011']
3029,33009186,Effect of spontaneous breathing on atelectasis during induction of general anaesthesia in infants: A prospective randomised controlled trial.,"BACKGROUND
Atelectasis occurs commonly during induction of general anaesthesia in children, particularly infants.
OBJECTIVES
We hypothesised that maintaining spontaneous ventilation can reduce atelectasis formation during anaesthetic induction in infants. We compared spontaneous ventilation and manual positive-pressure ventilation in terms of atelectasis formation in infants.
DESIGN
Randomised controlled study.
SETTING
Single tertiary hospital in Seoul, Republic of Korea, from November 2018 to December 2019.
PATIENTS
We enrolled 60 children younger than 1 year of age undergoing general anaesthesia, of whom 56 completed the study. Exclusion criteria were history of hypoxaemia during previous general anaesthesia, development of a respiratory tract infection within 1 month, current intubation or tracheostomy cannulation, need for rapid sequence intubation, preterm birth, age within 60 weeks of the postconceptional age and the presence of contraindications for rocuronium or sodium thiopental.
INTERVENTION
Patients were allocated randomly to either the 'spontaneous' group or 'controlled' group. During preoxygenation, spontaneous ventilation was maintained in the 'spontaneous' group while conventional bag-mask ventilation was provided in the 'controlled' group. After 5 min of preoxygenation, a lung ultrasound examination was performed to compare atelectasis formation in the two groups.
RESULTS
Atelectasis after preoxygenation was seen in seven (26.9%) of 26 patients in the 'spontaneous' group and 22 (73.3%) of 30 patients in the 'controlled' group (P = 0.001). The relative risk of atelectasis in the 'spontaneous' group was 0.39 (95% CI 0.211 to 0.723). Regarding ultrasound pictures of consolidation, the total score and sum of scores in the dependent regions were significantly lower in the 'spontaneous' group than in the 'controlled' group (P = 0.007 and 0.001, respectively).
CONCLUSION
Maintaining spontaneous ventilation during induction of general anaesthesia has a preventive effect against atelectasis in infants younger than 1 year of age, particularly in the dependent portions of the lungs.
TRIAL REGISTRATION
Clinicaltrials.gov (identifier: NCT03739697).",2020,"CONCLUSION
Maintaining spontaneous ventilation during induction of general anaesthesia has a preventive effect against atelectasis in infants younger than 1 year of age, particularly in the dependent portions of the lungs.
","['children, particularly infants', 'Single tertiary hospital in Seoul, Republic of Korea, from November 2018 to December 2019', '60 children younger than 1 year of age undergoing general anaesthesia, of whom 56 completed the study', 'infants younger than 1 year of age, particularly in the dependent portions of the lungs', 'Exclusion criteria were history of hypoxaemia during previous general anaesthesia, development of a respiratory tract infection within 1 month, current intubation or tracheostomy cannulation, need for rapid sequence intubation, preterm birth, age within 60 weeks of the postconceptional age and the presence of contraindications for', 'infants']","['conventional bag-mask ventilation', ""spontaneous' group or 'controlled' group"", 'spontaneous ventilation and manual positive-pressure ventilation', 'rocuronium or sodium thiopental', 'spontaneous breathing']","['relative risk of atelectasis', 'total score and sum of scores', 'atelectasis formation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C5200706', 'cui_str': 'Rapid Sequence Intubation'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0936073', 'cui_str': 'Thiopental sodium'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",60.0,0.155551,"CONCLUSION
Maintaining spontaneous ventilation during induction of general anaesthesia has a preventive effect against atelectasis in infants younger than 1 year of age, particularly in the dependent portions of the lungs.
","[{'ForeName': 'Sang-Hwan', 'Initials': 'SH', 'LastName': 'Ji', 'Affiliation': 'From the Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital (S-HJ, HSJ, Y-EJ, E-HK, J-HL, J-TK, H-SK) and Department of Anaesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea (J-TK, H-SK).'}, {'ForeName': 'Hwan Suk', 'Initials': 'HS', 'LastName': 'Jang', 'Affiliation': ''}, {'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': ''}, {'ForeName': 'Eun-Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001327']
3030,33009448,Crawl positioning improves set-up precision and patient comfort in prone whole breast irradiation.,"Prone positioning for whole-breast irradiation (WBI) reduces dose to organs at risk, but reduces set-up speed, precision, and comfort. We aimed to improve these problems by placing patients in prone crawl position on a newly developed crawl couch (CrC). A group of 10 right-sided breast cancer patients requiring WBI were randomized in this cross-over trial, comparing the CrC to a standard prone breastboard (BB). Laterolateral (LL), craniocaudal (CC) and anterioposterior (AP) set-up errors were evaluated with cone beam CT. Comfort, preference and set-up time (SUT) were assessed. Forty left and right-sided breast cancer patients served as a validation group. For BB versus CrC, AP, LL and CC mean patient shifts were - 0.8 ± 2.8, 0.2 ± 11.7 and - 0.6 ± 4.4 versus - 0.2 ± 3.3, - 0.8 ± 2.5 and - 1.9 ± 5.7 mm. LL shift spread was reduced significantly. Nine out of 10 patients preferred the CrC. SUT did not differ significantly. The validation group had mean patient shifts of 1.7 ± 2.9 (AP), 0.2 ± 3.6 (LL) and - 0.2 ± 3.3 (CC) mm. Mean SUT in the validation group was 1 min longer (P < 0.05) than the comparative group. Median SUT was 3 min in all groups. The CrC improved precision and comfort compared to BB. Set-up errors compare favourably to other prone-WBI trials and rival supine positioning.",2020,"Prone positioning for whole-breast irradiation (WBI) reduces dose to organs at risk, but reduces set-up speed, precision, and comfort.","['10 right-sided breast cancer patients requiring WBI', 'placing patients in prone crawl position on a newly developed crawl couch (CrC', 'Forty left and right-sided breast cancer patients']","['Prone positioning for whole-breast irradiation (WBI', 'CrC']","['Median SUT', 'Laterolateral (LL), craniocaudal (CC) and anterioposterior ', 'Mean SUT', 'Comfort, preference and set-up time (SUT', 'LL shift spread']","[{'cui': 'C4042789', 'cui_str': 'Right Sided Breast Neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0235042', 'cui_str': 'Does crawl'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0235042', 'cui_str': 'Does crawl'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}]",40.0,0.0157239,"Prone positioning for whole-breast irradiation (WBI) reduces dose to organs at risk, but reduces set-up speed, precision, and comfort.","[{'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Deseyne', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000, Gent, Belgium. pieter.deseyne@uzgent.be.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Speleers', 'Affiliation': 'Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'De Neve', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Boute', 'Affiliation': 'Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Paelinck', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vakaet', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Van Hulle', 'Affiliation': 'Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Schoepen', 'Affiliation': 'Industrial Design Center, Faculty of Engineering and Architecture, Ghent University, Marksesteenweg 58, 8500, Kortrijk, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stouthandel', 'Affiliation': 'Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Van Greveling', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Post', 'Affiliation': 'Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Detand', 'Affiliation': 'Industrial Design Center, Faculty of Engineering and Architecture, Ghent University, Marksesteenweg 58, 8500, Kortrijk, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Monten', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Depypere', 'Affiliation': 'Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Veldeman', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000, Gent, Belgium.'}]",Scientific reports,['10.1038/s41598-020-72702-3']
3031,32981192,Dietary intake on days with and without hypoglycemia in youth with type 1 diabetes: The Flexible Lifestyle Empowering Change trial.,"OBJECTIVE
To address a common perception that hypoglycemia is associated with increased dietary intake, we examined calorie and carbohydrate consumption on days with and without hypoglycemia among adolescents with type 1 diabetes (T1D).
METHODS
Days (N = 274) with 24-hour dietary recalls and continuous glucose monitoring were available for 122 adolescents with T1D in the Flexible Lifestyle Empowering Change trial (age 13-16 years, diabetes duration >1 year, hemoglobin A1c 8%-13%). Days with no hypoglycemia, clinical hypoglycemia (54-69 mg/dL) or clinically serious hypoglycemia (<54 mg/dL) were further split into night (12-5:59 am) and day (6 am-11:59 pm). Mixed models tested whether intake of calories or carbohydrates was greater on days with than without hypoglycemia.
RESULTS
Fifty-nine percent, 23% and 18% of days had no hypoglycemia, clinical hypoglycemia and clinically serious hypoglycemia, respectively. Intake of calories and carbohydrates was not statistically significantly different on days with clinical hypoglycemia (57.2 kcal [95% CI -126.7, 241.5]; 12.6 g carbohydrate [95% CI -12.7, 38.0]) or clinically serious hypoglycemia (-74.0 kcal [95% CI -285.9, 137.9]; (-7.8 g carbohydrate [95% CI -36.8, 21.1]), compared to days without hypoglycemia. Differences by day and night were not statistically significant.
CONCLUSIONS
Among adolescents with T1D, daily intake of calories and carbohydrates did not differ on days with and without hypoglycemia. It is possible that hypoglycemic episodes caused by undereating relative to insulin dosing, followed by overeating, leading to a net neutral difference. Given the post-hoc nature of these analyses, larger studies should be designed to prospectively test the hypoglycemia-diet relationship.",2020,"Among adolescents with T1D, daily intake of calories and carbohydrates did not differ on days with and without hypoglycemia.","['adolescents with type 1 diabetes (T1D', 'Days (N = 274) with', 'youth with type 1 diabetes', '122 adolescents with T1D in the Flexible Lifestyle Empowering Change trial (age 13-16\u2009years, diabetes duration >1\u2009year, hemoglobin A1c 8%-13']",['24-hour dietary recalls and continuous glucose monitoring'],"['hypoglycemia, clinical hypoglycemia', 'hypoglycemia, clinical hypoglycemia and clinically serious hypoglycemia', 'clinically serious hypoglycemia', 'clinical hypoglycemia', 'Intake of calories and carbohydrates']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]",274.0,0.0374345,"Among adolescents with T1D, daily intake of calories and carbohydrates did not differ on days with and without hypoglycemia.","[{'ForeName': 'Daria', 'Initials': 'D', 'LastName': 'Igudesman', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Crandell', 'Affiliation': 'School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, USA.'}, {'ForeName': 'Victor W', 'Initials': 'VW', 'LastName': 'Zhong', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York, 14853, USA.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Cristello Sarteau', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, USA.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Kahkoska', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Corbin', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, 32804, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, 32804, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Kosorok', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Maahs', 'Affiliation': 'Department of Pediatrics, Division of Endocrinology, Stanford University, Stanford, California, 94305, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Mayer-Davis', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, USA.'}]",Pediatric diabetes,['10.1111/pedi.13132']
3032,33022911,"Free-Weight Resistance Exercise Is More Effective in Enhancing Inhibitory Control than Machine-Based Training: A Randomized, Controlled Trial.","Resistance exercise has been demonstrated to improve brain function. However, the optimal workout characteristics are a matter of debate. This randomized, controlled trial aimed to elucidate differences between free-weight (RE free ) and machine-based (RE mach ) training with regard to their ability to acutely enhance cognitive performance (CP). A total of n = 46 healthy individuals (27 ± 4 years, 26 men) performed a 45-min bout of RE free (military press, barbell squat, bench press) or RE mach (shoulder press, leg press, chest press). Pre- and post-intervention, CP was examined using the Stroop test, Trail Making Test and Digit Span test. Mann-Whitney U tests did not reveal between-group differences for performance in the Digit Span test, Trail Making test and the color and word conditions of the Stroop test ( p > 0.05). However, RE free was superior to RE mach in the Stroop color-word condition (+6.3%, p = 0.02, R = 0.35). Additionally, RE free elicited pre-post changes in all parameters except for the Digit Span test and the word condition of the Stroop test while RE mach only improved cognitive performance in part A of the Trail Making test. Using free weights seems to be the more effective RE method to acutely improve cognitive function (i.e., inhibitory control). The mechanisms of this finding merit further investigation.",2020,"Mann-Whitney U tests did not reveal between-group differences for performance in the Digit Span test, Trail Making test and the color and word conditions of the Stroop test ( p > 0.05).","['A total of n = 46 healthy individuals (27 ± 4 years, 26 men']","['free-weight (RE free ) and machine-based (RE mach ) training', '45-min bout of RE free (military press, barbell squat, bench press) or RE mach (shoulder press, leg press, chest press', 'Resistance exercise', 'Free-Weight Resistance Exercise', 'Pre- and post-intervention']","['cognitive performance', 'Stroop test, Trail Making Test and Digit Span test', 'Digit Span test, Trail Making test and the color and word conditions of the Stroop test', 'brain function']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1144061', 'cui_str': 'CASP8 protein, human'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0454325', 'cui_str': 'Shoulder press'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",46.0,0.0275825,"Mann-Whitney U tests did not reveal between-group differences for performance in the Digit Span test, Trail Making test and the color and word conditions of the Stroop test ( p > 0.05).","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wilke', 'Affiliation': 'Department of Sports Medicine, Goethe University, Ginnheimer Landstraße 39, 60487 Frankfurt am Main, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Stricker', 'Affiliation': 'Department of Sports Medicine, Goethe University, Ginnheimer Landstraße 39, 60487 Frankfurt am Main, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Usedly', 'Affiliation': 'Department of Sports Medicine, Goethe University, Ginnheimer Landstraße 39, 60487 Frankfurt am Main, Germany.'}]",Brain sciences,['10.3390/brainsci10100702']
3033,33023276,Impact of Nuun Electrolyte Tablets on Fluid Balance in Active Men and Women.,"BACKGROUND
Maintaining adequate hydration is important for overall health and has major implications for athletes involved in physically demanding tasks. While water is viewed as an effective means to rehydrate, and is inexpensive and readily available, electrolyte beverages appear to be more beneficial, in particular for athletes who routinely lose electrolytes through sweating. Nuun tablets contain a mix of electrolytes and are quickly dissolved in water to create an electrolyte-rich beverage. We determined the impact of Nuun tablets on the fluid balance of healthy, exercise-trained men and women at rest.
METHODS
Eight men (25.9 ± 4.5 yrs) and 10 women (28.2 ± 9.4 yrs) ingested either water only or water with Nuun electrolyte tablets, at both a single and double strength concentration, in random order, on three separate occasions separated by approximately one week, in a fasted and euhydrated state. A total of 1 liter of fluid was ingested at each visit over a 30 minute period. Urine was collected from each subject at 0, 1, 2, 3, and 4 hours post-ingestion. Urine mass values were used to calculate fluid balance and the beverage hydration index (BHI; i.e., the volume of urine produced after drinking the Nuun beverages, relative to that of water only-control condition). Heart rate and blood pressure were measured throughout the four-hour period, while body weight was measured at the start and end of the experiment.
RESULTS
Neither heart rate nor blood pressure were impacted by beverage consumption. Nuun tablets resulted in a lower urine output compared to water, with fluid balances for both concentrations more favorable compared to water ( p < 0.05), beginning at 2 h post-ingestion and continuing at the 3 h and 4 h times. Body weight loss was less with Nuun at the single dose (0.38 kg; p = 0.02) and double dose (0.43 kg; p = 0.08), compared to water (0.57 kg). The BHI was higher for Nuun (single dose in particular) compared to water at both 2 h ( p = 0.05) and 4 h ( p = 0.02).
CONCLUSION
The addition of Nuun electrolyte tablets to water improves the fluid balance and BHI in healthy men and women. Results were similar for both concentrations, suggesting that additional electrolytes are not necessary when in a rested state. Future studies should determine the impact of various concentrations of the Nuun beverage during physical exercise-in particular, exercise in the heat, when sweat loss may be highest.",2020,"Body weight loss was less with Nuun at the single dose (0.38 kg; p = 0.02) and double dose (0.43 kg; p = 0.08), compared to water (0.57 kg).","['healthy men and women', 'Active Men and Women', 'Eight men (25.9 ± 4.5 yrs) and 10 women (28.2 ± 9.4 yrs', 'healthy, exercise-trained men and women at rest']","['Nuun tablets', 'Nuun Electrolyte Tablets', 'ingested either water only or water with Nuun electrolyte tablets']","['Body weight loss', 'heart rate nor blood pressure', 'BHI', 'Heart rate and blood pressure', 'body weight', 'fluid balance and BHI', 'lower urine output', 'Fluid Balance']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0443144', 'cui_str': 'At rest'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0028961', 'cui_str': 'Oliguria'}]",,0.0942113,"Body weight loss was less with Nuun at the single dose (0.38 kg; p = 0.02) and double dose (0.43 kg; p = 0.08), compared to water (0.57 kg).","[{'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Pence', 'Affiliation': 'Center for Nutraceutical and Dietary Supplement Research, University of Memphis, 161 Roane Fieldhouse, Memphis, TN 38152, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Bloomer', 'Affiliation': 'Center for Nutraceutical and Dietary Supplement Research, University of Memphis, 161 Roane Fieldhouse, Memphis, TN 38152, USA.'}]",Nutrients,['10.3390/nu12103030']
3034,32998416,"Nutritional Intervention Reduces Dyslipidemia, Fasting Glucose and Blood Pressure in People Living with HIV/AIDS in Antiretroviral Therapy: A Randomized Clinical Trial Comparing Two Nutritional Interventions.","Antiretroviral therapy (ART) increases the risk of cardiometabolic diseases in people living with HIV/AIDS (PLWHA). However, there is a lack of evidence regarding the effectiveness of a nutritional intervention on several cardiometabolic parameters in this population. Therefore, this study aimed to evaluate the effectiveness of two nutritional interventions on several cardiometabolic parameters in PLWHA treated with ART. A parallel randomized clinical trial was performed with PLWHA treated with ART. The participants ( n = 88) were divided into two intervention groups: (1) nutritional counseling ( n = 44) and (2) individualized dietary prescription ( n = 44). The follow-up period was 30 weeks. A reduction in low-density lipoprotein (LDL) was the primary outcome. Secondary outcome variables were reductions in total cholesterol (TC), triglycerides (TG), fasting plasma glucose (FPG), systolic and diastolic blood pressures (SBP and DBP, respectively), waist circumference (WC), body mass index (BMI), and increases in high-density lipoproteins (HDL). A multiple linear regression was used to analyze the effectiveness of the interventions, adjusted for sociodemographic, lifestyle, and clinical characteristics. Sixty-two PLWHA completed the trial (nutritional counseling, n = 32; individualized dietary prescription, n = 30). At follow-up, we observed in the nutritional counseling group significant reductions in SBP ( p = 0.036) and DBP ( p = 0.001). Significant reductions in FPG ( p = 0.008) and DBP ( p = 0.023) were found in the individualized dietary prescription group. In the fully adjusted models, significant reductions in LDL, SBP, DBP, and BMI were found in the individualized dietary prescription group. In conclusion, the two investigated nutritional interventions were effective in reducing some cardiometabolic risk factors in PLWHA. However, after adjustments for covariates, the individualized dietary prescription showed significant reductions in the primary outcome and, also, in more cardiometabolic risk factors than the nutritional counseling.",2020,Significant reductions in FPG ( p = 0.008) and DBP ( p = 0.023) were found in the individualized dietary prescription group.,"['people living with HIV/AIDS (PLWHA', 'participants ( n = 88', 'People Living with HIV/AIDS in Antiretroviral Therapy']","['Nutritional Intervention', 'nutritional interventions', 'nutritional intervention', 'nutritional counseling ( n = 44) and (2) individualized dietary prescription', 'PLWHA treated with ART', 'Antiretroviral therapy (ART']","['Dyslipidemia, Fasting Glucose and Blood Pressure', 'total cholesterol (TC), triglycerides (TG), fasting plasma glucose (FPG), systolic and diastolic blood pressures (SBP and DBP, respectively), waist circumference (WC), body mass index (BMI), and increases in high-density lipoproteins (HDL', 'DBP', 'LDL, SBP, DBP, and BMI', 'low-density lipoprotein (LDL', 'cardiometabolic risk factors', 'several cardiometabolic parameters', 'FPG', 'SBP']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",88.0,0.0347523,Significant reductions in FPG ( p = 0.008) and DBP ( p = 0.023) were found in the individualized dietary prescription group.,"[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Aparecida Silveira', 'Affiliation': 'Department of Epidemiology & Public Health, Institute of Epidemiology & Health Care, University College London, London WC1E 6BT, UK.'}, {'ForeName': 'Marianne Oliveira', 'Initials': 'MO', 'LastName': 'Falco', 'Affiliation': 'Postgraduate Program in Health Sciences, Faculty of Medicine, Federal University of Goiás, Goiânia 74605-050, Brazil.'}, {'ForeName': 'Annelisa Silva E Alves de Carvalho', 'Initials': 'ASEAC', 'LastName': 'Santos', 'Affiliation': 'Postgraduate Program in Health Sciences, Faculty of Medicine, Federal University of Goiás, Goiânia 74605-050, Brazil.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Noll', 'Affiliation': 'Department of Public Health, Instituto Federal Goiano, Ceres 76300-000, Brazil.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Epidemiology & Public Health, Institute of Epidemiology & Health Care, University College London, London WC1E 6BT, UK.'}]",Nutrients,['10.3390/nu12102970']
3035,32998471,Lactobacillus reuteri DSM 17938 and Agave Inulin in Children with Cerebral Palsy and Chronic Constipation: A Double-Blind Randomized Placebo Controlled Clinical Trial.,"The main objective was to assess the efficacy of a probiotic ( Lactobacillus reuteri DSM 17938), a prebiotic (agave inulin), and a synbiotic on the stool characteristics in children with cerebral palsy and chronic constipation. Thirty-seven children with cerebral palsy and chronic constipation were included. The probiotic group received 1 × 10 8 colony forming unit (cfu) of L. reuteri DSM 17938 plus placebo, the prebiotic group received 4 g of agave inulin plus placebo, the synbiotic group received L. reuteri DSM 17938 plus agave inulin, and the placebo group received two placebos for 28 days. The probiotic group showed a significant decrease in stool pH ( p = 0.014). Stool consistency improved in the prebiotic group ( p = 0.008). The probiotic, prebiotic, and synbiotic groups showed a significant improvement in the history of excessive stool retention, the presence of fecal mass in the rectum, and the history of painful defecation. L. reuteri concentration in feces was higher in the probiotic group than in the placebo group ( p = 0.001) and showed an inverse correlation with stool pH in the probiotic group ( r = -0.762, p = 0.028). This study showed that the use of L. reuteri DSM 17938 and/or agave inulin improved the stool characteristics such as the history of painful defecation and the presence of fecal mass in the rectum against placebo in children with cerebral palsy and chronic constipation.",2020,"L. reuteri concentration in feces was higher in the probiotic group than in the placebo group ( p = 0.001) and showed an inverse correlation with stool pH in the probiotic group ( r = -0.762, p = 0.028).","['Children with Cerebral Palsy and Chronic Constipation', 'children with cerebral palsy and chronic constipation', 'Thirty-seven children with cerebral palsy and chronic constipation were included']","['probiotic ( Lactobacillus reuteri DSM 17938), a prebiotic (agave inulin), and a synbiotic', 'Lactobacillus reuteri DSM 17938 and Agave Inulin', 'placebo', 'DSM 17938 plus placebo, the prebiotic group received 4 g of agave inulin plus placebo, the synbiotic group received L. reuteri DSM 17938 plus agave inulin, and the placebo', 'Placebo', 'placebos']","['history of excessive stool retention, the presence of fecal mass', 'Stool consistency', 'stool pH', 'L. reuteri concentration in feces']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0331584', 'cui_str': 'Agave'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",37.0,0.16112,"L. reuteri concentration in feces was higher in the probiotic group than in the placebo group ( p = 0.001) and showed an inverse correlation with stool pH in the probiotic group ( r = -0.762, p = 0.028).","[{'ForeName': 'Andrea A García', 'Initials': 'AAG', 'LastName': 'Contreras', 'Affiliation': 'Departamento de Nutrición y Bienestar Integral, Escuela de Medicina, Instituto Tecnológico y de Estudios Superiores Monterrey Campus Guadalajara, C.P. 4520 Zapopan, Jalisco, Mexico.'}, {'ForeName': 'Edgar M Vásquez', 'Initials': 'EMV', 'LastName': 'Garibay', 'Affiliation': 'Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, C.P. 44340 Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Carmen A Sánchez', 'Initials': 'CAS', 'LastName': 'Ramírez', 'Affiliation': 'Departamento de la Facultad de Medicina, Facultad de Medicina, Universidad de Colima, C.P. 28040 Colima, Colima, Mexico.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fafutis Morris', 'Affiliation': 'Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, C.P. 44340 Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Vidal', 'Initials': 'V', 'LastName': 'Delgado Rizo', 'Affiliation': 'Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, C.P. 44340 Guadalajara, Jalisco, Mexico.'}]",Nutrients,['10.3390/nu12102971']
3036,33002745,Comparison of the effectiveness of the virtual simulator and video-assisted teaching on intravenous catheter insertion skills and self-confidence: A quasi-experimental study.,"BACKGROUND
With the advancement of technology, methods such as clinical scenarios, role playing, video demonstration and simulation are now used to develop psychomotor skills in nursing education. Virtual reality and video-assisted teaching are useful technologies for the development of skills and self-confidence. In the literature, there is a lack of studies comparing the effects of the two methods.
OBJECTIVES
The aim of study is to compare the effect of the virtual simulator and video assisted teaching on the level of intravenous catheterization skills and self-confidence of nursing students. Thus, students are enabled to develop skills and work efficiently without the need for an instructor.
METHODS
This study was a randomized controlled quasi-experimental study. A total of 60 students was included in the study (30 in the virtual simulator group and 30 in the video group). In the virtual simulator group, each student performed an intravenous catheter insertion in the virtual intravenous simulator. In the video group, each student watched a training video on the peripheral intravenous catheterization skill in a classroom setting. Each of the students' level of intravenous catheterization knowledge, psychomotor skill and self-confidence score was evaluated.
RESULTS
Post-test knowledge scores was higher than pretest knowledge scores for both groups. There were no significant difference between the groups in terms of post-test scores. Students' scores of psychomotor skills were found to be higher in the virtual simulator group and self-confidence scores were similar in both groups.
CONCLUSION
Teaching with the virtual simulator contributed to the students' skills more than the method used in the video training. Both methods are effective in the development of knowledge and self-confidence related to intravenous catheterization.",2020,"Students' scores of psychomotor skills were found to be higher in the virtual simulator group and self-confidence scores were similar in both groups.
","['60 students was included in the study (30 in the virtual simulator group and 30 in the video group', 'nursing students']","['Virtual reality and video-assisted teaching', 'virtual simulator and video assisted teaching', 'virtual simulator and video-assisted teaching']","[""Students' scores of psychomotor skills"", 'self-confidence scores', 'intravenous catheterization knowledge, psychomotor skill and self-confidence score']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",60.0,0.0559607,"Students' scores of psychomotor skills were found to be higher in the virtual simulator group and self-confidence scores were similar in both groups.
","[{'ForeName': 'Elif Günay', 'Initials': 'EG', 'LastName': 'İsmailoğlu', 'Affiliation': 'Izmir Bakircay University, İzmir, Turkey. Electronic address: elif.ismailoglu@bakircay.edu.tr.'}, {'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Orkun', 'Affiliation': 'Ege University, İzmir, Turkey.'}, {'ForeName': 'İsmet', 'Initials': 'İ', 'LastName': 'Eşer', 'Affiliation': 'Ege University, İzmir, Turkey.'}, {'ForeName': 'Ayten', 'Initials': 'A', 'LastName': 'Zaybak', 'Affiliation': 'Ege University, İzmir, Turkey.'}]",Nurse education today,['10.1016/j.nedt.2020.104596']
3037,33003989,The picture of the past: Pictures to cue autobiographical memory in Alzheimer's disease.,"INTRODUCTION
This study investigated the effect of pictorial cues on autobiographical memory in Alzheimer's disease (AD). We assessed autobiographical memory of patients with AD and cognitively normal older adults in two conditions.
METHODS
In one condition, the participants were provided with verbal instructions to retrieve three autobiographical memories. In the second condition, the same verbal instructions were provided; however, the participants were simultaneously presented with three pictures. We analyzed autobiographical memory regarding specificity, that is, the ability to remember unique events situated in time and space.
RESULTS
Analysis demonstrated higher autobiographical memory after verbal-and-visual cuing than after the no cue condition in both patients with AD and cognitively normal older adults.
DISCUSSION
Pictorial cues seem to be an effective method to alleviate autobiographical compromise in AD.",2020,"RESULTS
Analysis demonstrated higher autobiographical memory after verbal-and-visual cuing than after the no cue condition in both patients with AD and cognitively normal older adults.
","[""Alzheimer's disease (AD"", 'patients with AD and cognitively normal older adults in two conditions', 'patients with AD and cognitively normal older adults', ""Alzheimer's disease""]",['pictorial cues'],"['autobiographical memory', 'autobiographical memory after verbal-and-visual cuing']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",,0.0364736,"RESULTS
Analysis demonstrated higher autobiographical memory after verbal-and-visual cuing than after the no cue condition in both patients with AD and cognitively normal older adults.
","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'El Haj', 'Affiliation': 'Laboratoire de psychologie des Pays de la Loire, LPPL, EA 4638, Univ Nantes , Nantes, France.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kapogiannis', 'Affiliation': 'Laboratory of Clinical Investigation, National Institute on Aging , Baltimore, MD, USA.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Antoine', 'Affiliation': 'CNRS, CHU Lille, UMR 9193 - SCALab - Sciences Cognitives et Sciences Affectives, Univ. Lille , Lille, France.'}]",Journal of clinical and experimental neuropsychology,['10.1080/13803395.2020.1825636']
3038,33006966,"Disapproval from romantic partners, friends and parents: Source of criticism regulates prefrontal cortex activity.","The prevalence of criticism in everyday social situations, and its empirically demonstrated association with psychopathology, highlight the importance of understanding neural mechanisms underlying the perception and response of individuals to criticism. However, neuroimaging studies to date have been limited largely to maternal criticism. The present study aims to investigate neural responses to observing criticism occurring in the context of three different relationship types: romantic partners, friends, and parents-from a third-party perspective. 49 participants were recruited and asked to rate the perceived criticism for these relationships. Functional near-infrared spectroscopy was used to measure changes in oxygenated haemoglobin levels in the prefrontal cortex when participants read vignettes describing three different scenarios of criticism. Participants were randomly assigned to 3 groups where the given description of the relationship of the protagonist to the source of criticism for each vignette was randomised. A significant interaction between relationship type and perceived criticism ratings for mothers was found in the dorsolateral prefrontal cortex. Compared to low perceived criticism, high perceived criticism individuals showed increased activation reading vignettes describing criticism from romantic partners and parents but decreased activation for those from friends. Findings contribute to understanding neural responses to criticism as observed from a third-party perspective. Future studies can look into differentiating neural responses of personalised experiences of criticism and third-party observations.",2020,A significant interaction between relationship type and perceived criticism ratings for mothers was found in the dorsolateral prefrontal cortex.,"['49 participants', 'Disapproval from romantic partners, friends and parents']",[],"['oxygenated haemoglobin levels', 'criticism ratings']","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",[],"[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",49.0,0.0291149,A significant interaction between relationship type and perceived criticism ratings for mothers was found in the dorsolateral prefrontal cortex.,"[{'ForeName': 'Michelle Jin-Yee', 'Initials': 'MJ', 'LastName': 'Neoh', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Atiqah', 'Initials': 'A', 'LastName': 'Azhari', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Mulatti', 'Affiliation': 'Department of Psychology and Cognitive Science, University of Trento, Rovereto, Italy.'}, {'ForeName': 'Marc H', 'Initials': 'MH', 'LastName': 'Bornstein', 'Affiliation': 'Child and Family Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, Untied States of America.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}]",PloS one,['10.1371/journal.pone.0229316']
3039,33011429,Training older adults with virtual reality use to improve collision-avoidance behavior when walking through an aperture.,"Many older adults perform collision-avoidance behavior either insufficiently (i.e., frequent collision) or inefficiently (i.e., exaggerated behavior to ensure collision-avoidance). The present study examined whether a training system using virtual reality (VR) simulation enhanced older adults' collision-avoidance behavior in response to a VR image of an aperture during real walking. Twenty-five (n = 13 intervention group and n = 12 control group) older individuals participated. During training, a VR image of walking through an aperture was projected onto a large screen. Participants in the intervention group tried to avoid virtual collision with the minimum body rotation required to walk on the spot through a variety of narrow apertures. Participants in the control group remained without body rotation while walking on the spot through a wide aperture. A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group. This suggests that the training led participants to modify their behavior to try to move efficiently during real walking. However, although not significant, collision rates also tended to be greater, suggesting that, at least for some participants, the modification required to avoid collision was too difficult. Transfer of the learned behavior using the VR environment to real walking is discussed.",2020,"A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group.","['Training older adults with virtual reality', 'n\u202f=\u202f12 control group) older individuals participated']","['avoid virtual collision with the minimum body rotation required to walk on the spot through a variety of narrow apertures', 'training system using virtual reality (VR) simulation']","['body rotation', 'collision rates', 'smaller body rotation angles']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",,0.0141464,"A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group.","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan; Department of Physical Rehabilitation, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Kazunobu', 'Initials': 'K', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Suda', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan. Electronic address: higuchit@tmu.ac.jp.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104265']
3040,33011482,Combined utility of blood glucose and white blood cell in predicting outcome after acute ischemic stroke: The ENCHANTED trial.,"BACKGROUND
As hyperglycemia and leukocytosis individually predict poor outcome in acute ischemic stroke (AIS), we aimed to determine the significance of their combination on functional outcome and symptomatic intracerebral hemorrhage (sICH) among participants of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).
METHODS
Post-hoc analyzes of the full ENCHANTED cohort, an international, multicenter, quasi-factorial, randomized, open, blinded outcome-assessed trial of low- versus standard-dose intravenous alteplase and early intensive versus standard blood pressure (BaP) lowering treatment in 4557 thrombolysis-eligible and treated AIS patients. Patients were divided into four groups according to baseline blood glucose and white blood cells (WBC) levels: A (normal glucose + WBC), B (hyperglycemia + normal WBC), C (normal glucose + high WBC), and D (hyperglycemia + high WBC). Logistic regression models were used to determine associations of each group and poor functional outcome (modified Rankin scale scores 2-6) at 90 days and sICH within 48 h, adjusted for confounders. Quality of model fit was examined with Akaike information classification (AIC), Bayesian information classification (BIC), and likelihood ratio test.
RESULTS
Of 4181 AIS patients included in analyzes, and with group A as the reference, an increasing odds of poor functional outcome was evident across groups B (odds ratio [OR] 1.38, 95 % confidence interval [CI] 1.17-1.63), C (OR 1.26, 95 %CI 0.99-1.60), and D (OR 2.26, 95 %CI 1.79-2.85) (P trend <0.001). Group D patients also had a higher rate of sICH (P trend <0.05). The model fit with the combination of blood glucose and WBC was better than models of their individual components.
CONCLUSIONS
Using a combination of blood glucose and WBC provides strong prognostic significance than either alone in thrombolyzed AIS patients.",2020,Group D patients also had a higher rate of sICH (P trend <0.05).,"['4557 thrombolysis-eligible and treated AIS patients', 'participants of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED', 'acute ischemic stroke', '4181 AIS patients', 'acute ischemic stroke (AIS', 'thrombolyzed AIS patients']","['low- versus standard-dose intravenous alteplase and early intensive versus standard blood pressure (BaP) lowering treatment', 'blood glucose and white blood cell']","['rate of sICH', 'baseline blood glucose and white blood cells (WBC) levels: A (normal glucose\u2009+\u2009WBC), B (hyperglycemia\u2009+\u2009normal WBC), C (normal glucose\u2009+\u2009high WBC), and D (hyperglycemia\u2009+\u2009high WBC', 'blood glucose and WBC', 'Akaike information classification (AIC), Bayesian information classification (BIC), and likelihood ratio test']","[{'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0885454,Group D patients also had a higher rate of sICH (P trend <0.05).,"[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': 'Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China; The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Westmead Applied Research Centre, University of Sydney, Sydney, NSW, Australia; The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Department of Neurology, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia.'}, {'ForeName': 'Zien', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Department of Radiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, PR China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Carcel', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Department of Neurology, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Malavera', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Zeljka', 'Initials': 'Z', 'LastName': 'Calic', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Department of Neurology, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia; The George Institute China at Peking University Health Science Centre, Beijing, PR China; Heart Health Research Center, Beijing, PR China. Electronic address: canderson@georgeinstitute.org.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106254']
3041,33011539,Genital Self-Image in Adolescent Girls: The Effectiveness of a Brief Educational Video.,"The study investigated the effectiveness of a very brief video aimed at increasing adolescent girls' knowledge of the variation in normal female genital appearance and improving their attitudes towards their own genitals. The video was developed by the researchers and included information about the anatomical features of cisgender female genitals and their function, as well as emphasizing the diversity in the appearance of these features, particularly the external genitalia or vulvar region. A sample of 343 female adolescents aged 16-18 years were randomly assigned to view the educational video or a control video. The educational video significantly increased the girls' knowledge of female genital anatomy. The educational video also significantly increased genital appearance satisfaction and decreased consideration of undergoing cosmetic genital surgery or labiaplasty in the future. The participants who watched the educational video were also more likely to recommend focusing on the diversity in normal female genital appearance when educating other young people on the topic of female genital anatomy. Our results suggest that a very brief educational video could be a useful tool to assist young girls with their genital self-image.",2020,The educational video also significantly increased genital appearance satisfaction and decreased consideration of undergoing cosmetic genital surgery or labiaplasty in the future.,"['adolescent girls', '343 female adolescents aged 16-18 years', 'Adolescent Girls']","['educational video or a control video', 'Brief Educational Video']","['genital appearance satisfaction', 'Genital Self-Image', ""girls' knowledge of female genital anatomy""]","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0017421', 'cui_str': 'Female genital'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}]",343.0,0.014125,The educational video also significantly increased genital appearance satisfaction and decreased consideration of undergoing cosmetic genital surgery or labiaplasty in the future.,"[{'ForeName': 'Anne Nileshni', 'Initials': 'AN', 'LastName': 'Fernando', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Monash University, Melbourne, Victoria, 3004, Australia. Electronic address: anfer4@student.monash.edu.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Sharp', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Monash University, Melbourne, Victoria, 3004, Australia. Electronic address: gemma.sharp@monash.edu.'}]",Body image,['10.1016/j.bodyim.2020.08.007']
3042,33019888,A randomized control trial of intensive aphasia therapy after acute stroke: The Very Early Rehabilitation for SpEech (VERSE) study.,"BACKGROUND
Effectiveness of early intensive aphasia rehabilitation after stroke is unknown. The Very Early Rehabilitation for SpEech trial (VERSE) aimed to determine whether intensive aphasia therapy, beginning within 14 days after stroke, improved communication recovery compared to usual care.
METHODS
Prospective, randomized, single-blinded trial conducted at 17 acute-care hospitals across Australia/New Zealand from 2014 to 2018. Participants with aphasia following acute stroke were randomized to receive usual care (direct usual care aphasia therapy), or one of two higher intensity regimens (20 sessions of either non-prescribed (usual care-plus or prescribed (VERSE) direct aphasia therapy). The primary outcome was improvement of communication on the Western Aphasia Battery-Revised Aphasia Quotient (AQ) at 12 weeks after stroke. Our pre-planned intention to treat analysis combined high intensity groups for the primary outcome.
FINDINGS
Among 13,654 acute stroke patients screened, 25% (3477) had aphasia, of whom 25% (866) were eligible and 246 randomized to usual care ( n = 81; 33%), usual care-plus ( n = 82; 33%) or VERSE ( n = 83; 34%). At 12 weeks after stroke, the primary outcome was assessed in 217 participants (88%); 14 had died, 9 had withdrawn, and 6 were too unwell for assessment. Communication recovery was 50.3% (95% CI 45.7-54.8) in the high intensity group ( n = 147) and 52.1% (95% CI 46.1-58.1) in the usual care group ( n = 70; difference -1.8, 95% CI -8.7-5.0). There was no difference between groups in non-fatal or fatal adverse events ( p = 0.72).
INTERPRETATION
Early, intensive aphasia therapy did not improve communication recovery within 12 weeks post stroke compared to usual care.",2020,"There was no difference between groups in non-fatal or fatal adverse events ( p = 0.72).
","['13,654 acute stroke patients screened, 25% (3477) had aphasia, of whom 25% (866) were eligible and 246 randomized to usual care ( n \u2009=\u200981; 33', 'Participants with aphasia following acute stroke', '17 acute-care hospitals across Australia/New Zealand from 2014 to 2018', 'after acute stroke']","['VERSE', 'usual care (direct usual care aphasia therapy), or one of two higher intensity regimens (20 sessions of either non-prescribed (usual care-plus or prescribed (VERSE) direct aphasia therapy', 'usual care-plus', 'intensive aphasia therapy']","['Communication recovery', 'non-fatal or fatal adverse events', 'improvement of communication on the Western Aphasia Battery-Revised Aphasia Quotient (AQ', 'communication recovery']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4273775', 'cui_str': 'Western Aphasia Battery Revised'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}]",217.0,0.290293,"There was no difference between groups in non-fatal or fatal adverse events ( p = 0.72).
","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Godecke', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Armstrong', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Australia.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Rai', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Technology NSW, Broadway, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ciccone', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Australia.'}, {'ForeName': 'Miranda L', 'Initials': 'ML', 'LastName': 'Rose', 'Affiliation': 'School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': ""St Vincent's Health Australia, Sydney and Australian Catholic University, Darlinghurst, Australia.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Whitworth', 'Affiliation': 'Faculty of Health Sciences, Curtin University, Bentley, Australia.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Holland', 'Affiliation': 'Speech Language Pathology, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Ellery', 'Affiliation': 'Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'Medical School, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Dominique A', 'Initials': 'DA', 'LastName': 'Cadilhac', 'Affiliation': 'Stroke and Ageing Research, School of Clinical Science at Monash Health, Monash University, Clayton, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bernhardt', 'Affiliation': 'Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020961926']
3043,33017169,A Hybrid Transtibial Technique Combines the Advantages of Anteromedial Portal and Transtibial Approaches: A Prospective Randomized Controlled Trial.,"BACKGROUND
The anteromedial (AM) portal and transtibial (TT) approaches are 2 common anterior cruciate ligament (ACL) femoral tunnel drilling techniques, each with unique benefits and disadvantages. A hybrid TT (HTT) technique using medial portal guidance of a flexible TT guide wire has recently been described that may combine the strengths of both the AM portal and the TT approaches.
HYPOTHESIS
The HTT technique will achieve anatomic femoral tunnel apertures similar to the AM portal technique, with improved femoral tunnel length and orientation.
STUDY DESIGN
Randomized controlled trial; Level of evidence, 2.
METHODS
A total of 30 consecutive patients with primary ACL tears were randomized to undergo the TT, AM portal, or HTT technique for femoral tunnel positioning at the time of reconstruction. All patients underwent 3-dimensional computed tomography of the operative knee at 6 weeks postoperatively. Femoral and tibial tunnel aperture positions and tunnel lengths, as well as graft bending angles in the sagittal and coronal planes, were measured.
RESULTS
Tibial tunnel lengths and aperture positions were identical between the 3 groups. The AM portal and HTT techniques achieved identical femoral aperture positions in regard to both height ( P = .629) and depth ( P = .582). By contrast, compared with the AM portal and HTT techniques, femoral apertures created with the TT technique were significantly higher ( P < .001 and P < .001, respectively) and shallower ( P = .014 and P = .022, respectively) in the notch. The mean femoral tunnel length varied significantly between the groups, measuring 35.2, 41.6, and 54.1 mm for the AM portal, HTT, and TT groups, respectively ( P < .001). Last, there was no difference between the mean coronal ( P = .190) and sagittal ( P = .358) graft bending angles between the TT and HTT groups. By contrast, compared with the TT and HTT techniques, femoral tunnels created with the AM portal technique were significantly more angulated in the coronal plane (17.7° [ P < .001] and 12.5° [ P = .006], respectively) and sagittal plane (13.5° [ P < .001] and 10.5° [ P = .013], respectively).
CONCLUSION
This prospective randomized controlled trial found that the HTT technique achieved femoral aperture positions equally as anatomic as the AM portal technique but produced longer, less angulated femoral tunnels, which may help reduce graft strain and mismatch. As such, this hybrid approach may represent a beneficial combination of both the TT and the AM portal techniques.
REGISTRATION
NCT02795247 (ClinicalTrials.gov identifier).",2020,The AM portal and HTT techniques achieved identical femoral aperture positions in regard to both height ( P = .629) and depth ( P = .582).,['30 consecutive patients with primary ACL tears'],"['3-dimensional computed tomography', 'TT, AM portal, or HTT technique for femoral tunnel positioning', 'hybrid TT (HTT) technique', 'Anteromedial Portal and Transtibial Approaches']","['mean coronal', 'femoral tunnels created with the AM portal technique', 'Tibial tunnel lengths and aperture positions', 'sagittal plane', 'coronal plane', 'mean femoral tunnel length', 'Femoral and tibial tunnel aperture positions and tunnel lengths']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C3266783', 'cui_str': 'Length of wound tunneling'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}]",30.0,0.0466478,The AM portal and HTT techniques achieved identical femoral aperture positions in regard to both height ( P = .629) and depth ( P = .582).,"[{'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Trofa', 'Affiliation': 'Department of Orthopedics, NewYork-Presbyterian Hospital, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Bryan M', 'Initials': 'BM', 'LastName': 'Saltzman', 'Affiliation': 'Sports Medicine Center, OrthoCarolina, Charlotte, North Carolina, USA.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Corpus', 'Affiliation': 'Sports Medicine Center, OrthoCarolina, Charlotte, North Carolina, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Connor', 'Affiliation': 'Sports Medicine Center, OrthoCarolina, Charlotte, North Carolina, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Fleischli', 'Affiliation': 'Sports Medicine Center, OrthoCarolina, Charlotte, North Carolina, USA.'}, {'ForeName': 'Dana P', 'Initials': 'DP', 'LastName': 'Piasecki', 'Affiliation': 'Sports Medicine Center, OrthoCarolina, Charlotte, North Carolina, USA.'}]",The American journal of sports medicine,['10.1177/0363546520956645']
3044,33021143,Objective analysis of language use in cognitive-behavioral therapy: associations with symptom change in adults with co-occurring substance use disorders and posttraumatic stress.,"Substance use disorders (SUD) commonly co-occur with posttraumatic stress disorder (PTSD) symptoms, and the comorbidity is prevalent and difficult-to-treat. Few studies have objectively analyzed language use in psychotherapy as a predictor of treatment outcomes. We conducted a secondary analysis of patient language use during cognitive-behavioral therapy (CBT) in a randomized clinical trial, comparing a novel, integrated CBT for PTSD/SUD with standard CBT for SUD. Participants included 37 treatment-seeking, predominantly African-American adults with SUD and at least four symptoms of PTSD. We analyzed transcripts of a single, matched session across both treatment conditions, using the Linguistic Inquiry and Word Count (LIWC) program. The program measures language use across multiple categories. Compared to standard CBT for SUD, patients in the novel, integrated CBT for PTSD/SUD used more negative emotion words, partially consistent with our hypothesis, but less positive emotion words. Further, exploratory analyses indicated an association between usage of cognitive processing words and clinician-observed reduction in PTSD symptoms, regardless of treatment condition. Our results suggest that language use during therapy may provide a window into mechanisms active in therapy.",2020,"Compared to standard CBT for SUD, patients in the novel, integrated CBT for PTSD/SUD used more negative emotion words, partially consistent with our hypothesis, but less positive emotion words.","['Participants included 37 treatment-seeking, predominantly African-American adults with SUD and at least four symptoms of PTSD', 'adults with co-occurring substance use disorders and posttraumatic stress']","['language use in cognitive-behavioral therapy', 'patient language use during cognitive-behavioral therapy (CBT']",['positive emotion words'],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]",37.0,0.0173698,"Compared to standard CBT for SUD, patients in the novel, integrated CBT for PTSD/SUD used more negative emotion words, partially consistent with our hypothesis, but less positive emotion words.","[{'ForeName': 'Anthony N', 'Initials': 'AN', 'LastName': 'Jennings', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center , Houston, TX, USA.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Soder', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center , Houston, TX, USA.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Wardle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center , Houston, TX, USA.'}, {'ForeName': 'Joy M', 'Initials': 'JM', 'LastName': 'Schmitz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center , Houston, TX, USA.'}, {'ForeName': 'Anka A', 'Initials': 'AA', 'LastName': 'Vujanovic', 'Affiliation': 'Department of Psychology, University of Houston , Houston, TX, USA.'}]",Cognitive behaviour therapy,['10.1080/16506073.2020.1819865']
3045,33026658,Enhanced coping and self-efficacy in caregivers of stem cell transplant recipients: Identifying mechanisms of a multimodal psychosocial intervention.,"BACKGROUND
In a recent trial, a 6-session intervention (BMT-CARE) integrating medical information with cognitive-behavioral strategies improved quality of life (QOL), mood, coping skills, and self-efficacy for family/friend caregivers of hematopoietic stem cell transplantation (HCT) recipients. This study examined whether improvements in coping and self-efficacy mediated the intervention effects on QOL and mood.
METHODS
From December 2017 to April 2019, 100 caregivers of HCT recipients were enrolled into a randomized clinical trial of BMT-CARE versus usual care. Caregivers completed self-report measures of QOL (CareGiver Oncology Quality of Life questionnaire), depression and anxiety symptoms (Hospital Anxiety and Depression Scale), coping skills (Measure of Current Status), and self-efficacy (Cancer Self-Efficacy Scale-Transplant) at enrollment (before HCT) and 60 days after HCT. Causal mediation regression models were used to examine whether changes in coping and self-efficacy mediated intervention effects on QOL as well as depression and anxiety symptoms.
RESULTS
Improvements in 60-day QOL in patients assigned to BMT-CARE were partially mediated by improved coping and self-efficacy (indirect effect, 6.93; SE, 1.85; 95% CI, 3.71-11.05). Similarly, reductions in 60-day depression and anxiety symptoms were partially mediated by improved coping and self-efficacy (indirect effect for depression, -1.19; SE, 0.42; 95% CI, -2.23 to -0.53; indirect effect for anxiety, -1.46; SE, 0.55; 95% CI, -2.52 to -0.43). Combined improvements in coping and self-efficacy accounted for 67%, 80%, and 39% of the total intervention effects on QOL and depression and anxiety symptoms, respectively.
CONCLUSIONS
Coping and self-efficacy are essential components of a brief psychosocial intervention that improves QOL and mood for caregivers of HCT recipients during the acute recovery period.
LAY SUMMARY
A 6-session program (BMT-CARE) focused on providing medical information, caregiving skills, and self-care and coping strategies has been previously reported to improve the quality of life and mood of caregivers of hematopoietic stem cell transplantation recipients in comparison with caregivers who receive care as usual. Using statistical models, this study suggests that learning coping skills and improving self-efficacy are the most essential components of this program that likely lead to better quality of life and mood for caregivers.",2020,"RESULTS
Improvements in 60-day QOL in patients assigned to BMT-CARE were partially mediated by improved coping and self-efficacy (indirect effect, 6.93; SE, 1.85; 95% CI, 3.71-11.05).","['caregivers of HCT recipients during the acute recovery period', 'family/friend caregivers of hematopoietic stem cell transplantation (HCT) recipients', 'caregivers of stem cell transplant recipients', 'From December 2017 to April 2019, 100 caregivers of HCT recipients']","['6-session program (BMT-CARE', 'BMT-CARE versus usual care']","['QOL and depression and anxiety symptoms', 'Enhanced coping and self-efficacy', 'coping and self-efficacy', 'improved coping and self-efficacy', 'QOL (CareGiver Oncology Quality of Life questionnaire), depression and anxiety symptoms (Hospital Anxiety and Depression Scale), coping skills (Measure of Current Status), and self-efficacy (Cancer Self-Efficacy Scale-Transplant', 'QOL and mood', 'quality of life (QOL), mood, coping skills, and self-efficacy', '60-day depression and anxiety symptoms']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0430127,"RESULTS
Improvements in 60-day QOL in patients assigned to BMT-CARE were partially mediated by improved coping and self-efficacy (indirect effect, 6.93; SE, 1.85; 95% CI, 3.71-11.05).","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Jacobs', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Nelson', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Traeger', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Waldman', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Showly', 'Initials': 'S', 'LastName': 'Nicholson', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Annemarie D', 'Initials': 'AD', 'LastName': 'Jagielo', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': ""D'Alotto"", 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}]",Cancer,['10.1002/cncr.33191']
3046,33022318,Treating tobacco dependence to aid re-employment among job-seekers: A randomized controlled trial.,"INTRODUCTION
U.S. reductions in smoking have not been experienced equally. Smoking prevalence is greater among persons of lower education, lower income, and unemployed. We evaluated whether a cessation intervention for job-seekers would result in significantly fewer cigarettes smoked per day and a greater likelihood of tobacco abstinence and re-employment, compared to the control condition at 6-months follow-up.
METHODS
Unemployed, job-seekers who smoked daily were recruited from five employment development departments in the San Francisco Bay Area, October 2015 to February 2018. Intention to quit smoking was not required. Participants were randomized to a brief motivationally-tailored, computer-assisted counseling intervention or referred to a toll-free quitline. Midstudy, 8-weeks of combination nicotine replacement was added to the intervention. Expired carbon monoxide and cotinine testing verified abstinence. Data were analyzed fall 2019.
RESULTS
Participants (N = 360; 70% men; 43% African American, 27% non-Hispanic Caucasian; 19% unhoused) averaged 12 cigarettes/day (SD = 6), 67% smoked within 30 min of wakening; 27% were in preparation stage to quit. During the 6-month study period, intervention participants were more likely to make a quit attempt (71% vs. 58%, p = .021) and reported significantly greater reduction in cigarettes/day than control participants (median reduction: 6.9 vs. 5.0, p = .038); however, bioconfirmed abstinence (3%) and re-employment (36%) did not differ by treatment group.
CONCLUSIONS
In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition. A priority group, further research is needed on smoking and re-employment.",2020,"In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition.","['Participants (N\u202f=\u202f360; 70% men; 43% African American, 27% non-Hispanic Caucasian', 'job-seekers', 'Unemployed, job-seekers who smoked daily were recruited from five employment development departments in the San Francisco Bay Area, October 2015 to February 2018']","['nicotine replacement', 'brief motivationally-tailored, computer-assisted counseling intervention or referred to a toll-free quitline']","['bioconfirmed abstinence', 'quit attempt', 'quit attempts and smoking reduction']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}]",,0.0440133,"In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition.","[{'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America. Electronic address: jpro@stanford.edu.'}, {'ForeName': 'Cati', 'Initials': 'C', 'LastName': 'Brown-Johnson', 'Affiliation': 'Evaluation Sciences Unit, Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baiocchi', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Lazaro', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chieng', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Stinson', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Anzai', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106259']
3047,33022321,Use of a GP-endorsed non-participant reminder letter to promote uptake of bowel scope screening: A randomised controlled trial in a hard-to-reach population.,"Previous research suggests that sending non-participants a reminder letter, 1 year after their initial invitation, can improve coverage for bowel scope screening (BSS), also known as flexible sigmoidoscopy screening. We hypothesised that adding a general practitioner's (GPs) endorsement to the reminder letter could improve coverage even further. We conducted a randomised controlled trial in North West London, UK. Participants were screening-eligible men and women who had not responded to their initial BSS invitation at least 12 months prior to the trial period. Eligible adults were randomised in a 1:1 ratio to receive either a GP-endorsed reminder letter, or a standard reminder letter from June to August 2019. Logistic regression models were used to test the effect of the GP endorsement on attendance at BSS, adjusting for sex, clinical commissioning group, and local area socioeconomic deprivation. In total, 1200 participants were enrolled into the study and randomised to either the control (n = 600) or the intervention (n = 600) group. Those who received the GP-endorsed reminder letter were only slightly more likely to attend BSS than those who received the standard reminder letter (4% vs. 3%); this difference was not statistically significant (Adjusted OR = 1.30; 95% CI: 0.69, 2.43). Adding a GP-endorsement to the annual reminder letter did not have an effect on attendance at BSS. One possible explanation for this is that the endorsement used was not personalised enough. Future research should examine stronger GP-endorsements or other methods to promote uptake.",2020,Adding a GP-endorsement to the annual reminder letter did not have an effect on attendance at BSS.,"['Participants were screening-eligible men and women who had not responded to their initial BSS invitation at least 12\u202fmonths prior to the trial period', 'North West London, UK', 'Eligible adults', '1200 participants were enrolled into the study and randomised to either the control (n\u202f=\u202f600) or the intervention (n\u202f=\u202f600) group']","['GP-endorsed reminder letter, or a standard reminder letter from June to August 2019', 'GP-endorsed non-participant reminder letter']",[],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],1200.0,0.121819,Adding a GP-endorsement to the annual reminder letter did not have an effect on attendance at BSS.,"[{'ForeName': 'Aradhna', 'Initials': 'A', 'LastName': 'Kaushal', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK. Electronic address: aradhna.kaushal.14@ucl.ac.uk.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Hirst', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Tookey', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Kerrison', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Marshall', 'Affiliation': ""St Mark's Bowel Cancer Screening Centre, London North West University Healthcare NHS Trust, Harrow, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prentice', 'Affiliation': ""St Mark's Bowel Cancer Screening Centre, London North West University Healthcare NHS Trust, Harrow, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vulkan', 'Affiliation': 'Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Duffy', 'Affiliation': 'Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Wagner', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106268']
3048,33022324,Fit and Strong! Plus: Twelve and eighteen month follow-up results for a comparative effectiveness trial among overweight/obese older adults with osteoarthritis.,"This comparative effectiveness trial compared the longer-term effectiveness (12 and 18 months) of the standard Fit & Strong! physical activity program to Fit & Strong! Plus, which combined physical activity and dietary weight loss. Outcomes were weight, diet quality, physical activity, osteoarthritis symptoms, performance measures, and anxiety/depression. In this study, 413 overweight/obese participants with OA, ≥60 years old and primarily African American, were randomly assigned to Fit & Strong! (F&S!) or Fit & Strong! Plus (F&S! Plus), with outcomes assessed at 2, 6, 12, and 18 months. 356 (86%) participants completed the 18-month visit. Compared with participants randomized to standard F&S!, F&S! Plus participants maintained longer-term benefits at 12 months in weight (mean change ± SE: -1.7 ± 0.3 kg for F&S! Plus vs -0.9 ± 0.3 kg for F&S!, p = 0.049), BMI (-0.6 ± 0.1 vs -0.3 ± 0.1 kg/m 2 , p = 0.04), waist circumference (-2.7 ± 0.6 vs -0.4 ± 0.6 cm, p = 0.004), and lower extremity strength (1.6 ± 0.2 vs 1.0 ± 0.2 chair stands, p = 0.046). At 18 months, F&S! Plus participants showed improved lower extremity strength (1.4 ± 0.2 vs. 0.7 ± 0.2 chair stands, p = 0.045. African American older adults in the F&S! Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.",2020,"Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.","['356 (86%) participants completed the 18-month visit', 'African American older adults in the F&S', '413 overweight/obese participants with OA, ≥60\u202fyears old and primarily African American', 'overweight/obese older adults with osteoarthritis']","['Plus (F&S', 'Fit & Strong', 'physical activity program to Fit & Strong', 'standard Fit & Strong', 'standard F&S!, F&S', 'F&S']","['BMI', 'weight, waist circumference, and lower extremity strength', 'weight, diet quality, physical activity, osteoarthritis symptoms, performance measures, and anxiety/depression', 'waist circumference', 'lower extremity strength']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",413.0,0.0535567,"Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.","[{'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Fitzgibbon', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; University of Illinois Cancer Center, 818 South Wolcott Avenue, Chicago, IL 60612, United States of America; Department of Pediatrics, University of Illinois at Chicago, 840 South Wood Street, Chicago, IL 60612, United States of America. Electronic address: mlf@uic.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tussing-Humphreys', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; University of Illinois Cancer Center, 818 South Wolcott Avenue, Chicago, IL 60612, United States of America; Department of Medicine, University of Illinois at Chicago, 808 South Wood Street, Chicago, IL 60612, United States of America.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Renae', 'Initials': 'R', 'LastName': 'Smith-Ray', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Health Analytics, Research and Reporting, Walgreen Co., 102 Wilmot Road, Deerfield, IL 60015, United States of America.'}, {'ForeName': 'David X', 'Initials': 'DX', 'LastName': 'Marquez', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Department of Kinesiology and Nutrition, University of Illinois at Chicago, 1919 West Taylor Street, Chicago, IL 60612, United States of America.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'DeMott', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Berbaum', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Hughes', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Division of Community Health Sciences, University of Illinois at Chicago, 1603 West Taylor Street, IL 60612, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106267']
3049,33022345,Effects of tDCS on neuroplasticity and inflammatory biomarkers in bipolar depression: Results from a sham-controlled study.,"OBJECTIVES
We investigated the role of peripheral biomarkers associated with neuroplasticity and immune-inflammatory processes on the effects of transcranial direct current stimulation (tDCS), a safe, affordable, and portable non-invasive neuromodulatory treatment, in bipolar depression.
METHODS
This is an exploratory analysis using a dataset from the sham-controlled study the Bipolar Depression Electrical Treatment Trial (BETTER)(clinicaltrials.govNCT02152878). Participants were 52 adults with type I or II bipolar disorder in a moderate-to-severe depressive episode, randomized to 12 bifrontal active or sham tDCS sessions over a 6-week treatment course. Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint. We performed analyses unadjusted for multiple testing to evaluate whether baseline biomarkers were predictive for depression improvement and changed during treatment using linear regression models.
RESULTS
A time x group interaction (Cohen's d: -1.16, 95% CI = -1.96 to -0.3, p = .005) was found for IL-8, with greater reductions after active tDCS. Higher baseline IL-6 plasma levels was associated with symptomatic improvement after tDCS (F (1,43) = 5.43; p = .025). Other associations were not significant.
CONCLUSIONS
Our exploratory findings suggested that IL-6 is a potential predictor of tDCS response and IL-8 might decrease after tDCS; although confirmatory studies are warranted due to the multiplicity of comparisons.",2020,"Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint.","['bipolar depression', 'Participants were 52 adults with type I or II bipolar disorder in a moderate-to-severe depressive episode']","['12 bifrontal active or sham tDCS sessions', 'transcranial direct current stimulation (tDCS', 'tDCS']","['Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2', 'neuroplasticity and inflammatory biomarkers', 'Higher baseline IL-6 plasma levels']","[{'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}]","[{'cui': 'C0445448', 'cui_str': 'Bifrontal'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0450499', 'cui_str': 'ST2'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",52.0,0.250759,"Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint.","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Goerigk', 'Affiliation': 'Department of Psychological Methodology and Assessment, Ludwig-Maximilians-University, Munich, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität, Nußbaumstraße 7, 80336 Munich, Germany; Hochschule Fresenius, University of Applied Sciences, Munich, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cretaz', 'Affiliation': 'ECT Service, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Bipolar Disorder Research Program, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Sampaio-Junior', 'Affiliation': 'Private practice, São Paulo, Brazil.'}, {'ForeName': 'Érica Leandro Marciano', 'Initials': 'ÉLM', 'LastName': 'Vieira', 'Affiliation': 'Interdisciplinary Laboratory of Medical Investigation, Faculdade de Medicina, Universidade Federal de Minas Gerais, Minas Gerais, Brazil; Centre for Addiction and Mental Healthy (CAMH), Toronto, ON, Canada.'}, {'ForeName': 'Wagner', 'Initials': 'W', 'LastName': 'Gattaz', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Izio', 'Initials': 'I', 'LastName': 'Klein', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Beny', 'Initials': 'B', 'LastName': 'Lafer', 'Affiliation': 'Bipolar Disorder Research Program, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Antônio Lúcio', 'Initials': 'AL', 'LastName': 'Teixeira', 'Affiliation': 'Interdisciplinary Laboratory of Medical Investigation, Faculdade de Medicina, Universidade Federal de Minas Gerais, Minas Gerais, Brazil; Neuropsychiatry Program, Department of Psychiatry and Behavioral Science, UT Health, Houston, United States of America.'}, {'ForeName': 'André F', 'Initials': 'AF', 'LastName': 'Carvalho', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Healthy (CAMH), Toronto, ON, Canada.'}, {'ForeName': 'Paulo A', 'Initials': 'PA', 'LastName': 'Lotufo', 'Affiliation': 'Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil.'}, {'ForeName': 'Isabela M', 'Initials': 'IM', 'LastName': 'Benseñor', 'Affiliation': 'Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Bühner', 'Affiliation': 'Department of Psychological Methodology and Assessment, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität, Nußbaumstraße 7, 80336 Munich, Germany.'}, {'ForeName': 'André R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil. Electronic address: brunoni@usp.br.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110119']
3050,33024237,The effect of aldosterone and aldosterone blockade on the progression of chronic kidney disease: a randomized placebo-controlled clinical trial.,"The progression of chronic kidney disease (CKD) cannot be completely inhibited. We first explored factors contributing to CKD progression in patients with CKD in a prospective observational study. In the next phase, we focused on the effects of aldosterone, conducting a single-blinded placebo-controlled study using the selective mineralocorticoid receptor antagonist (MRA), eplerenone (25 mg/day). We recruited patients with CKD stage 2 and 3 whose plasma aldosterone concentration was above 15 ng/dL based on the prior data of a prospective observational study. In the CKD cohort study (n = 141), baseline plasma aldosterone concentration was identified as an independent contributory factor for the future rate of change in estimated glomerular filtration rate (eGFR). When the cut-off value for aldosterone was set at 14.5 ng/dL, the decline rate was significantly higher in patients with higher plasma aldosterone concentration (- 1.22 ± 0.39 ml/min/1.73 m 2 /year vs. 0.39 ± 0.40 ml/min/1.73 m 2 /year, p = 0.0047). In the final intervention study, in the eplerenone group, eGFR dropped at 6 months after the initiation of the study, and thereafter eGFR was maintained until the end of the study. At 24 months and 36 months, eGFR was significantly higher in the eplerenone group than in the placebo group. In conclusion, MRA can be an effective strategy in preventing CKD progression, especially in patients with high plasma aldosterone.",2020,"At 24 months and 36 months, eGFR was significantly higher in the eplerenone group than in the placebo group.","['patients with CKD', 'patients with CKD stage 2 and 3 whose plasma aldosterone concentration was above 15\xa0ng/dL based on the prior data of a prospective observational study', 'patients with high plasma aldosterone', 'chronic kidney disease']","['aldosterone', 'MRA', 'eplerenone', 'placebo', 'aldosterone and aldosterone blockade', 'selective mineralocorticoid receptor antagonist (MRA), eplerenone']","['progression of chronic kidney disease (CKD', 'baseline plasma aldosterone concentration', 'eGFR', 'decline rate', 'glomerular filtration rate (eGFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C2316786', 'cui_str': 'Chronic kidney disease stage 2'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",,0.0289782,"At 24 months and 36 months, eGFR was significantly higher in the eplerenone group than in the placebo group.","[{'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Minakuchi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Wakino', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. shuwakino@z8.keio.jp.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Urai', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Kurokochi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kanda', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Hirobumi', 'Initials': 'H', 'LastName': 'Tokuyama', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}]",Scientific reports,['10.1038/s41598-020-73638-4']
3051,33025749,Holmium laser enucleation of the prostate using Moses 2.0 vs non-Moses: a randomised controlled trial.,"OBJECTIVES
To compare the enucleation efficiency of Moses 2.0 with non-Moses technology in patients undergoing holmium laser enucleation of the prostate (HoLEP).
PATIENTS AND METHODS
A double-blinded, randomised study of patients undergoing HoLEP at the Mayo Clinic in Arizona, using the Lumenis Pulse™ 120H laser system. Patients were randomised to either right lobe enucleation using Moses 2.0 and left lobe enucleation using non-Moses, or the opposite. The primary outcome was individual lobe enucleation efficiency. Secondary outcomes included individual lobe laser time, laser energy, individual enucleation and haemostasis laser energies, and fibre burn back. Two independent reviewers watched videos of the procedures and provided a subjective evaluation of the technologies.
RESULTS
A total of 27 patients were included in the study. For the entire cohort, Moses 2.0 had less fibre degradation (3.5 vs 16.8 mm, P < 0.01) compared to non-Moses. When HoLEP procedures were performed by an expert, Moses 2.0 resulted in shorter enucleation time (21 vs 36.7 min, P = 0.016) and higher enucleation efficiency (1.75 vs 1.05 g/min, P = 0.05) compared to non-Moses. When HoLEP was performed by trainees, the Moses 2.0 cohort had a shorter haemostasis laser time (4.1 vs 9 min, P = 0.035) compared to the non-Moses. Fibre degradation was lower with Moses 2.0 compared to non-Moses for both experts and trainees. Moses 2.0 received a higher score than the standard technology for the incision sharpness, fibre control, tissue separation, tissue damage, haemostasis, visibility, and charring. The overall inter-observer correlation coefficient was 0.63.
CONCLUSION
Moses 2.0 has higher enucleation efficiency compared to non-Moses when used by experts. The subjective evaluation favoured Moses 2.0.",2020,"Moses 2.0 received higher score than the standard technology with respect to the incision sharpness, fiber control, tissue separation, tissue damage, hemostasis, visibility, and Charring.","['patients undergoing Laser enucleation of the prostate (HoLEP', 'patients undergoing HoLEP at Mayo Clinic in Arizona, using the Lumenis Pulse™ 120H laser system', 'Twenty-seven patients were included in the study']","['right lobe enucleation using Moses 2.0 and left lobe enucleation using non-Moses, or the opposite', 'Holmium laser enucleation']","['higher enucleation efficiency', 'shorter hemostasis laser time', 'enucleation efficiency', 'fiber degradation', 'individual lobe laser time, laser energy, individual enucleation and hemostasis laser energies, and fiber burn back', 'shorter enucleation time', 'individual lobe enucleation efficiency', 'Fiber degradation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1293635', 'cui_str': 'Laser enucleation of the prostate'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0003787', 'cui_str': 'Arizona - US state'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C3873738', 'cui_str': 'Laser system'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0227481', 'cui_str': 'Structure of right lobe of liver'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0026574', 'cui_str': 'mos Oncogenes'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}]",27.0,0.041238,"Moses 2.0 received higher score than the standard technology with respect to the incision sharpness, fiber control, tissue separation, tissue damage, hemostasis, visibility, and Charring.","[{'ForeName': 'Amihay', 'Initials': 'A', 'LastName': 'Nevo', 'Affiliation': 'Department of Urology, Mayo Clinic in Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Kassem S', 'Initials': 'KS', 'LastName': 'Faraj', 'Affiliation': 'Department of Urology, Mayo Clinic in Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Cheney', 'Affiliation': 'Department of Urology, Mayo Clinic in Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Moore', 'Affiliation': 'Department of Urology, Mayo Clinic in Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Stern', 'Affiliation': 'Department of Urology, Mayo Clinic in Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Borofsky', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Gnessin', 'Affiliation': ""Department of Urology, Shamir Medical Center, Be'er Ya'akov, Israel.""}, {'ForeName': 'Mitchell R', 'Initials': 'MR', 'LastName': 'Humphreys', 'Affiliation': 'Department of Urology, Mayo Clinic in Arizona, Phoenix, AZ, USA.'}]",BJU international,['10.1111/bju.15265']
3052,33001840,Correction: Comparing Classroom Instruction to Individual Instruction as an Approach to Teach Avatar-Based Patient Monitoring With Visual Patient: Simulation Study.,[This corrects the article DOI: 10.2196/17922.].,2020,[This corrects the article DOI: 10.2196/17922.].,[],['Classroom Instruction to Individual Instruction'],[],[],"[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],,0.0131278,[This corrects the article DOI: 10.2196/17922.].,"[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Rössler', 'Affiliation': 'University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kaserer', 'Affiliation': 'University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Albiez', 'Affiliation': 'University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': 'Biostatistics and Prevention Institute, Departments of Epidemiology and Biostatistics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Breckwoldt', 'Affiliation': 'University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Donat Rudolf', 'Initials': 'DR', 'LastName': 'Spahn', 'Affiliation': 'University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nöthiger', 'Affiliation': 'University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'David Werner', 'Initials': 'DW', 'LastName': 'Tscholl', 'Affiliation': 'University Hospital Zurich, Zurich, Switzerland.'}]",JMIR medical education,['10.2196/24459']
3053,33002644,Bilateral nucleus basalis of Meynert deep brain stimulation for dementia with Lewy bodies: A randomised clinical trial.,,2020,,['Dementia with Lewy Bodies'],['Bilateral Nucleus Basalis of Meynert D Brain Stimulation'],[],"[{'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}]",[],,0.259573,,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, No.70, Heping Road, Weihai, Shandong, China, 264200. Electronic address: liuwei881x@outlook.com.'}, {'ForeName': 'Dong-Yan', 'Initials': 'DY', 'LastName': 'Yu', 'Affiliation': 'Weihai Municipal Third Hospital, Weihai, Shandong, China, 264205. Electronic address: yudongyan@outlook.com.'}]",Brain stimulation,['10.1016/j.brs.2020.09.020']
3054,33002645,Enhancing cognitive training effects in Alzheimer's disease: rTMS as an add-on treatment.,"The treatment of Alzheimer's disease (AD) in the field of non-pharmacological interventions is a challenging issue, given the limited benefits of the available drugs. Cognitive training (CT) represents a commonly recommended strategy in AD. Recently, repetitive transcranial magnetic stimulation (rTMS) has gained increasing attention as a promising therapeutic tool for the treatment of AD, given its ability of enhancing neuroplasticity. In the present randomized, double-blind, sham-controlled study, we aimed at investigating the add-on effect of a high frequency rTMS protocol applied over the left dorsolateral prefrontal cortex (DLPFC) combined with a face-name associative memory CT in the continuum of AD pathology. Fifty patients from a very early to a moderate phase of dementia were randomly assigned to one of two groups: CT plus real rTMS or CT plus placebo rTMS. The results showed that the improvement in the trained associative memory induced with rTMS was superior to that obtained with CT alone. Interestingly, the extent of the additional improvement was affected by disease severity and levels of education, with less impaired and more educated patients showing a greater benefit. When testing for generalization to non-trained cognitive functions, results indicated that patients in CT-real group showed also a greater improvement in visuospatial reasoning than those in the CT-sham group. Interestingly, this improvement persisted over 12 weeks after treatment beginning. The present study provides important hints on the promising therapeutic use of rTMS in AD.",2020,The results showed that the improvement in the trained associative memory induced with rTMS was superior to that obtained with CT alone.,"['Fifty patients from a very early to a moderate phase of dementia', ""Alzheimer's disease""]","['rTMS', 'CT plus real rTMS or CT plus placebo rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'Cognitive training (CT']","['visuospatial reasoning', 'disease severity and levels of education', 'trained associative memory']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",50.0,0.0608235,The results showed that the improvement in the trained associative memory induced with rTMS was superior to that obtained with CT alone.,"[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bagattini', 'Affiliation': 'Cognitive Neuroscience Section, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy. Electronic address: chiara.bagattini@cognitiveneuroscience.it.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Zanni', 'Affiliation': ""Fondazione Europea Ricerca Biomedica, Ospedale Sant'Isidoro, 24069, Trescore Balneario, Bergamo, Italy.""}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Barocco', 'Affiliation': ""Fondazione Europea Ricerca Biomedica, Ospedale Sant'Isidoro, 24069, Trescore Balneario, Bergamo, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Caffarra', 'Affiliation': 'Department of Medicine and Surgery, Section of Neuroscience, University of Parma, 43126, Parma, Italy.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Brignani', 'Affiliation': 'Cognitive Neuroscience Section, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Miniussi', 'Affiliation': 'Center for Mind/Brain Sciences- CIMeC, University of Trento, 38068, Rovereto, Italy.'}, {'ForeName': 'Carlo Alberto', 'Initials': 'CA', 'LastName': 'Defanti', 'Affiliation': ""Fondazione Europea Ricerca Biomedica, Ospedale Sant'Isidoro, 24069, Trescore Balneario, Bergamo, Italy.""}]",Brain stimulation,['10.1016/j.brs.2020.09.010']
3055,33002684,Positive memory training for the treatment of depression in schizophrenia: A randomised controlled trial.,"BACKGROUND
Around half of people diagnosed with schizophrenia suffer from co-morbid depression, yet there are no evidence-based psychological treatments to target this presentation.
METHOD
Participants were aged 18-65 years old, had a clinical diagnosis of schizophrenia or schizoaffective disorder and at least a mild level of depression. Participants were randomly assigned (1:1) to receive PoMeT or treatment as usual. PoMeT was delivered in up to 12 individual sessions within 3 months. We stratified randomisation by site and by severity of depression using randomised-permuted blocks. Assessments were carried out at baseline, 3-month, 6-month and 9-month by assessors who were blind to treatment allocation. The primary outcome was reduction in the symptoms of depression at 3-month, 6-month and 9-month as measured by the BDI-II. Analysis was by intention-to-treat with linear mixed-effects models. The trial was registered with the ISRCTN registry number 99485756.
RESULTS
One hundred participants were randomly assigned to either PoMeT (n = 49) or treatment as usual (n = 51). The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
DISCUSSION
To our knowledge this is, to date, the largest powered randomised controlled trial focused on the psychological treatment of depression in people diagnosed with schizophrenia. Results indicate that a brief targeted intervention can reduce the symptoms of depression in the group. The main limitation of the study is the lack of an active control group which may contribute to an inflated treatment effect.",2020,"The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
","['people diagnosed with schizophrenia', 'One hundred participants', 'Participants were aged 18-65 years old, had a clinical diagnosis of schizophrenia or schizoaffective disorder and at least a mild level of depression', 'depression in schizophrenia']","['PoMeT', 'Positive memory training']","['symptoms of depression', 'symptoms of depression at 3-month, 6-month and 9-month as measured by the BDI-II', 'reduction in BDI-II total score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0561841', 'cui_str': 'Pleasant memories'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.285473,"The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Steel', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, UK; School of Psychology, University of Reading, UK. Electronic address: craig.steel@hmc.ox.ac.uk.'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Korrelboom', 'Affiliation': 'Department of Anxiety Disorders, PsyQ Parnassia Group, Psychiatric Center, The Hague, the Netherlands; Department of Medical and Clinical Psychiatry, Tilburg University, Tilburg, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fazil Baksh', 'Affiliation': 'Department of Mathematics and Statistics, University of Reading, Whiteknights, Reading, RG6 6AL, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kingdon', 'Affiliation': 'University of Southampton, Highfield, Southampton, SO17 1BJ, UK.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Simon', 'Affiliation': 'Department of Health Economics, Center for Public Health, Medical University of Vienna, 1090, Wien, Kinderspitalgasse 15, Austria; Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford OX3 7JX, UK.'}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Wykes', 'Affiliation': 'Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Phiri', 'Affiliation': 'Southern Health NHS Foundation Trust, Research & Development Department, Tom Rudd Unit, Moorgreen Hospital, Botley Rd, West End Southampton, SO30 3JB, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van der Gaag', 'Affiliation': 'VU University and Amsterdam Public Mental Health Research Institute, Department of Clinical Psychology Van der Boechorststraat 1, 1081, BT, Amsterdam, the Netherlands; Parnassia Psychiatric Institute, Zoutkeetsingel 40, 2512, HN, The Hague, the Netherlands.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103734']
3056,33002685,Collaborative care for depression in older adults: How much is enough?,"Collaborative care in primary care has been shown to be effective for subthreshold depression in older adults in the 'CASPER' trial. However, to understand the impact of adherence, and to explore the minimum effective dose of collaborative care, we reanalysed the trial data using a complier average causal effect (CACE) analysis. Data were available for 705 participants, 519 with 12-month PHQ-9 scores. 'Compliance' could be observed for participants in the intervention group. Latent complier status in the control group was estimated. Completion of five or more sessions of care was defined as 'compliance'. Sensitivity analyses, using alternative cut-offs of two to eight sessions, assessed the impact of changing the definition of 'compliance'. Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported. Sensitivity analyses confirmed statistically significant differences between the intervention and control groups in those attending five or more sessions. We conclude that collaborative care is causally effective in reducing subthreshold depressive symptoms in older people who adhere to treatment. Our findings suggest the minimum effective dose is five sessions.",2020,"Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported.","['older adults', '705 participants, 519 with 12-month PHQ-9 scores. ', 'older people who adhere to treatment']","['collaborative care', 'Collaborative care']","['lower PHQ-9 scores', 'subthreshold depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",705.0,0.060507,"Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported.","[{'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Bonvoisin', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull University Teaching Hospitals NHS Trust, Hull, HU3 2JZ, UK. Electronic address: ttb508@york.ac.uk.'}, {'ForeName': 'Lewis W', 'Initials': 'LW', 'LastName': 'Paton', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK. Electronic address: lewis.paton@york.ac.uk.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK. Electronic address: catherine.hewitt@york.ac.uk.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'McMillan', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: dean.mcmillan@york.ac.uk.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: simon.gilbody@york.ac.uk.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tiffin', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: paul.tiffin@york.ac.uk.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103725']
3057,33004790,"Acute effects of whey protein on energy intake, appetite and gastric emptying in younger and older, obese men.","BACKGROUND
Obesity is becoming more prevalent in older people. A management strategy in obese, young adults is to increase dietary protein relative to other macronutrients. It is not clear if this is effective in obese, older individuals. Obesity may be associated with diminished sensitivity to nutrients. We have reported that a 30-g whey protein drink slows gastric emptying more, and suppresses energy intake less, in older, than younger, non-obese men. The aim of this study was to determine the effect of a 30 g whey protein drink on energy intake, GE and glycaemia in obese, older and younger men.
METHODS
In randomized, double-blind order, 10 younger (age: 27 ± 2 years; BMI: 36 ± 2 kg/m²), and 10 older (72 ± 1 years; 33 ± 1 kg/m²), obese men were studied twice. After an overnight fast, subjects ingested a test drink containing 30 g whey protein (120 kcal) or control (2 kcal). Postprandial gastric emptying (antral area, 2D Ultrasound) and blood glucose concentrations were measured for 180 min. At t = 180 min subjects were given a buffet meal and ad libitum energy intake was assessed.
RESULTS
Older subjects ate non-significantly less (~20%) that the younger subjects (effect of age, P = 0.16). Whey protein had no effect on subsequent energy intake (kcal) compared to control in either the younger (decrease 3 ± 8%) or older (decrease 2 ± 8%) obese men (age effect P > 0.05, protein effect P = 0.46, age × protein interaction effect P = 0.84). Whey protein slowed gastric emptying, to a similar degree in both age groups (50% emptying time: control vs. protein young men: 255 ± 5 min vs. 40 ± 7 min; older men: 16 ± 5 min vs. 50 ± 8 min; protein effect P = 0.001, age effect P = 0.93, age × protein interaction effect P = 0.13).
CONCLUSIONS
Our data suggest that obesity may blunt/abolish the age-related effect of whey protein on suppression of energy intake.",2020,"Whey protein had no effect on subsequent energy intake (kcal) compared to control in either the younger (decrease 3 ± 8%) or older (decrease 2 ± 8%) obese men (age effect P > 0.05, protein effect P = 0.46, age × protein interaction effect P = 0.84).","['younger and older, obese men', 'older, than younger, non-obese men', 'older people', 'obese, young adults', 'obese, older and younger men', '10 younger (age: 27\u2009±\u20092\u2009years; BMI: 36\u2009±\u20092\u2009kg/m²), and 10 older (72\u2009±\u20091\u2009years; 33\u2009±\u20091\u2009kg/m²), obese men', 'obese, older individuals']","['whey protein', '30\u2009g whey protein drink']","['subsequent energy intake (kcal', 'energy intake, GE and glycaemia', 'Postprandial gastric emptying (antral area, 2D Ultrasound) and blood glucose concentrations', 'gastric emptying', 'energy intake, appetite and gastric emptying']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}]",,0.0726594,"Whey protein had no effect on subsequent energy intake (kcal) compared to control in either the younger (decrease 3 ± 8%) or older (decrease 2 ± 8%) obese men (age effect P > 0.05, protein effect P = 0.46, age × protein interaction effect P = 0.84).","[{'ForeName': 'Avneet', 'Initials': 'A', 'LastName': 'Oberoi', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia, SA, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Giezenaar', 'Affiliation': 'Riddet Institute, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Jensen', 'Affiliation': 'Centre for Nutrition, Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia, SA, Australia.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Hausken', 'Affiliation': 'Department of Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia, SA, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia, SA, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chapman', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia, SA, Australia.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Soenen', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia, SA, Australia. stijn.soenen@adelaide.edu.au.'}]",Nutrition & diabetes,['10.1038/s41387-020-00139-8']
3058,33006501,Post-placental intrauterine device insertion vs puerperal insertion in women undergoing caesarean delivery in Egypt: a 1 year randomised controlled trial.,"OBJECTIVE
The aim of the study was to compare 6 month expulsion rates of the copper-bearing intrauterine device (IUD) inserted after delivery of the placenta or at the 6 week postpartum visit in women undergoing caesarean section.
METHODS
A parallel-group randomised trial was conducted in an Egyptian university hospital between February 2016 and December 2018. Participants were randomised to either post-placental IUD insertion or IUD insertion at the 6 week postpartum visit. Participants were followed for 12 months. Primary outcomes were IUD expulsion and the proportion of women using an IUD at 6 months. A secondary outcome was the cumulative pregnancy rate at 12 months.
RESULTS
Five hundred participants were enrolled in each group. At 6 months the total expulsions were 58/416 (13.9%) in the post-placental group and 4/214 (1.9%) in the puerperal group; IUD use at 6 months was 416/478 (87.0%) in the post-placental group and 214/232 (92.2%) in the puerperal group. Data collected by phone at 12 months showed a higher cumulative pregnancy rate in the puerperal group (84/500, 16.8%) vs the post-placental group (22/500, 4.4%). IUD continuation at 12 months was higher in the post-placental group.
CONCLUSION
Participants in the post-placental group had a higher expulsion rate at 6 months, but more IUDs were placed in this group and fewer pregnancies had occurred at 12 months compared with the puerperal group.
TRIAL REGISTRATION
Clinicaltrials.gov NCT02679820.",2020,"Participants in the post-placental group had a higher expulsion rate at 6 months, but more IUDs were placed in this group and fewer pregnancies had occurred at 12 months compared with the puerperal group.
","['Egyptian university hospital between February 2016 and December 2018', 'women undergoing caesarean delivery in Egypt', 'women undergoing caesarean section', 'Five hundred participants were enrolled in each group']","['post-placental IUD insertion or IUD insertion', 'copper-bearing intrauterine device (IUD', 'Post-placental intrauterine device insertion vs puerperal insertion']","['total expulsions', 'higher expulsion rate', 'IUD expulsion and the proportion of women using an IUD at 6\u2009months', 'cumulative pregnancy rate']","[{'cui': 'C0013717', 'cui_str': 'Egyptian language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021899', 'cui_str': 'IUD expelled'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",500.0,0.35714,"Participants in the post-placental group had a higher expulsion rate at 6 months, but more IUDs were placed in this group and fewer pregnancies had occurred at 12 months compared with the puerperal group.
","[{'ForeName': 'Yomna A', 'Initials': 'YA', 'LastName': 'Bayoumi', 'Affiliation': 'Department of Obstetrics and Gynaecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Dina M R', 'Initials': 'DMR', 'LastName': 'Dakhly', 'Affiliation': 'Department of Obstetrics and Gynaecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Yasmin A', 'Initials': 'YA', 'LastName': 'Bassiouny', 'Affiliation': 'Department of Obstetrics and Gynaecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hisham M', 'Initials': 'HM', 'LastName': 'Gouda', 'Affiliation': 'Department of Obstetrics and Gynaecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Hassan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Hassan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Cairo University, Cairo, Egypt.'}]",The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception,['10.1080/13625187.2020.1823366']
3059,33007710,Working out the worries: A randomized controlled trial of high intensity interval training in generalized anxiety disorder.,"BACKGROUND
Aerobic exercise (AE) demonstrated an overall medium treatment effect in anxiety disorders (AD) but there is evidence for an ""intensity-response"" relationship. High intensity interval training (HIIT) was highly effective on a range of (mental) health parameters. However, so far no randomised-controlled trial (RCT) investigated the efficacy of HIIT in AD.
METHODS
33 patients with generalized anxiety disorder (GAD) were randomly assigned to 12-day HIIT or a training of lower intensity (LIT). Anxiety, comorbid depression, stress-related bodily symptoms and perceived control over anxiety related stimuli (PC) were assessed at baseline, post-training and 30 days after baseline by using the Penn State Worry Questionnaire (PSWQ), the Hamilton Inventories for Anxiety and Depression (Ham-A, Ham-D), the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
RESULTS
Both interventions showed moderate or large effects on all clinical measures. However, effects for HIIT were generally about twice as high as for LIT. PC negatively correlated with GAD severity in the whole sample at baseline but an association of training-induced changes in PC and worrying were exclusively detectable in HIIT.
CONCLUSION
HIIT was highly effective and fast acting in GAD. Therefore, it may complement first-line treatment approaches in this condition.",2020,", the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
","['generalized anxiety disorder', '33 patients with generalized anxiety disorder (GAD']","['Aerobic exercise (AE', 'High intensity interval training (HIIT', 'high intensity interval training', '12-day HIIT or a training of lower intensity (LIT']","['Anxiety, comorbid depression, stress-related bodily symptoms and perceived control over anxiety related stimuli (PC', 'Penn State Worry Questionnaire (PSWQ), the Hamilton Inventories for Anxiety and Depression', 'GAD severity', 'Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C2959752', 'cui_str': 'Penn State worry questionnaire'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",33.0,0.0824276,", the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
","[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Plag', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: jens.plag@charite.de.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Schmidt-Hellinger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Sports Medicine, Berlin, Germany. Electronic address: paul-juergen.schmidt@charite.de.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Klippstein', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: theresa.klippstein@charite.de.'}, {'ForeName': 'Jennifer L M', 'Initials': 'JLM', 'LastName': 'Mumm', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: jennifer.mumm@charite.de.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wolfarth', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Sports Medicine, Berlin, Germany. Electronic address: bernd.wolfarth@charite.de.'}, {'ForeName': 'Moritz B', 'Initials': 'MB', 'LastName': 'Petzold', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: moritz.petzold@charite.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: andreas.stroehle@charite.de.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102311']
3060,33007851,Comparison of Skeletal and Dental Changes Obtained from a Tooth-Borne Maxillary Expansion Appliance Compared to the Damon System Assessed through a Digital Volumetric Imaging: A Randomized Clinical Trial.,"The purpose of this study was to evaluate and compare dental and skeletal changes associated with the Damon and Rapid Maxillary Expander (RME) expansion using Cone-Beam Computed Tomography (CBCT). Eighty-two patients, from The University of Alberta Orthodontic Clinic, were randomly allocated to either Group A or B. Patients in Group A received orthodontic treatment using the Damon brackets. Patients in Group B received treatment using the Hyrax (a type of RME) appliance. CBCT images were taken two times (baseline and after expansion). The AVIZO software was used to locate 18 landmarks (dental and skeletal) on sagittal, axial, and coronal slices of CBCT images. Comparison between two groups showed that transverse movement of maxillary first molars and premolars was much greater in the Hyrax group. The lateral movements of posterior teeth were associated with buccal tipping of crowns. No clinically significant difference in the vertical or anteroposterior direction between the two groups was noted. Alveolar bone next to root apex of maxillary first premolar and molar teeth showed clinically significant lateral movement in the Hyrax group only. The comparison between two groups showed significantly greater transverse expansion of the first molar and first premolars with buccal tipping in the RME group.",2020,The comparison between two groups showed significantly greater transverse expansion of the first molar and first premolars with buccal tipping in the RME group.,"['Eighty-two patients, from The University of Alberta Orthodontic Clinic']","['Damon and Rapid Maxillary Expander (RME) expansion using Cone-Beam Computed Tomography (CBCT', 'orthodontic treatment using the Damon brackets', 'Digital Volumetric Imaging', 'Hyrax (a type of RME) appliance']","['vertical or anteroposterior direction', 'transverse movement of maxillary first molars and premolars', 'transverse expansion', 'lateral movements of posterior teeth']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0020696', 'cui_str': 'Family Procaviidae'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C1321060', 'cui_str': 'Transverse movement'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]",82.0,0.0286724,The comparison between two groups showed significantly greater transverse expansion of the first molar and first premolars with buccal tipping in the RME group.,"[{'ForeName': 'Hye Jin', 'Initials': 'HJ', 'LastName': 'Nam', 'Affiliation': 'Faculty of Medicine and Dentistry, Department of Dentistry, Orthodontic Program, University of Alberta, ECHA, 11405-87th Avenue, Edmonton, AB T6G 1C9, Canada.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gianoni-Capenakas', 'Affiliation': 'Faculty of Medicine and Dentistry, Department of Dentistry, Orthodontic Program, University of Alberta, ECHA, 11405-87th Avenue, Edmonton, AB T6G 1C9, Canada.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Major', 'Affiliation': 'Faculty of Medicine and Dentistry, Department of Dentistry, Orthodontic Program, University of Alberta, ECHA, 11405-87th Avenue, Edmonton, AB T6G 1C9, Canada.'}, {'ForeName': 'Giseon', 'Initials': 'G', 'LastName': 'Heo', 'Affiliation': 'Faculty of Medicine and Dentistry, Department of Dentistry, Orthodontic Program, University of Alberta, ECHA, 11405-87th Avenue, Edmonton, AB T6G 1C9, Canada.'}, {'ForeName': 'Manuel O', 'Initials': 'MO', 'LastName': 'Lagravère', 'Affiliation': 'Faculty of Medicine and Dentistry, Department of Dentistry, Orthodontic Program, University of Alberta, ECHA, 11405-87th Avenue, Edmonton, AB T6G 1C9, Canada.'}]",Journal of clinical medicine,['10.3390/jcm9103167']
3061,33007878,Distinct Effects of Acute Aerobic Exercise on Declarative Memory and Procedural Memory Formation.,"Objective: To investigate the different effects of acute aerobic exercise on the formation of long-term declarative memory (DM) and procedural memory (PM). Methods: Twenty-two young men completed DM and PM tasks under three experimental conditions: pre-acquisition exercise, post-acquisition exercise, and no exercise (control). The DM task encompassed word learning, free recall tests both immediately and 1 h later, and a recognition test conducted 24 h after word learning. A serial reaction time task (SRTT) was utilized to assess exercise effects on PM. The SRTT included a sequence learning phase followed by sequence tests 1 h and 24 h later. The exercise program consisted of 30 min of moderate-intensity aerobic exercise. Results: In the DM task, compared to the control condition, pre-acquisition exercise, but not post-acquisition exercise, enhanced free recall performance significantly 1 h and 24 h later. The target word recognition rate and discriminative index (d') of the recognition test were significantly enhanced in both exercise conditions compared to the control condition. In the PM task, we observed significantly reduced (improved) reaction times at the 24-h test in the post-acquisition exercise condition compared to in the control condition. Conclusion: Acute aerobic exercise may enhance long-term DM and PM via effects on different processing periods. For DM, exercise had a pronounced effect during the encoding period, whereas for PM, exercise was found to have an enhancing effect during the consolidation period.",2020,The target word recognition rate and discriminative index (d') of the recognition test were significantly enhanced in both exercise conditions compared to the control condition.,['Methods: Twenty-two young men completed DM and PM tasks under three experimental conditions'],"['pre-acquisition exercise, post-acquisition exercise, and no exercise (control', 'Acute aerobic exercise', 'serial reaction time task (SRTT', 'acute aerobic exercise', 'Acute Aerobic Exercise', 'exercise program consisted of 30 min of moderate-intensity aerobic exercise']","['Declarative Memory and Procedural Memory Formation', 'formation of long-term declarative memory (DM) and procedural memory (PM', ' reaction times', ""target word recognition rate and discriminative index (d') of the recognition test"", 'free recall performance']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0561782', 'cui_str': 'Procedural memory'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",22.0,0.0402269,The target word recognition rate and discriminative index (d') of the recognition test were significantly enhanced in both exercise conditions compared to the control condition.,"[{'ForeName': 'Xuru', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Chenglin', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai 200438, China.'}]",Brain sciences,['10.3390/brainsci10100691']
3062,33009690,Outcomes of monthly video consultations as an add-on to regular care for children with type 1 diabetes: A 6-month quasi-randomized clinical trial followed by an extension phase.,"OBJECTIVE
To explore the outcomes of monthly video consultations for children with diabetes.
METHODS
The Virtual Outpatient Diabetes Clinic for Children and Youth (VIDIKI) was a 6-month multicenter controlled clinical trial followed by an extension phase. The 240 participants (1-16 years), all using a CGM, were quasi-randomized by residence location to the intervention group (IG) or the waitlist-control group (WG). The IG started immediately after enrollment with monthly video consultations as an add-on to regular care, while the WG received regular care for 6 months before starting the intervention. The extension phase lasted between 12 months and 2 years, depending on the enrollment date. Linear regression was applied to model the primary outcome of HbA1c after 6 months and other metabolic and psychosocial outcomes.
RESULTS
After covariate adjustments, the HbA1c at 6 months-corresponding to the controlled treatment phase-was 0.11% lower in the IG than that in the WG (95% CI -0.31 to 0.09, P = .277). For the total study sample, a significant HbA1c improvement was found after 12 months of video consultations, which increased further until month 15. The diabetes burden of the main caregivers was lower, and parental treatment satisfaction was significantly higher in the IG than that in the WG.
CONCLUSIONS
The VIDIKI study found no significant HbA1c difference between IG and WG after 6 months in the controlled phase, but there was a decreased diabetes burden and increased treatment satisfaction for the parents. In the longitudinal perspective, a significant HbA1c improvement was found after 12 and 15 months.",2020,"The diabetes burden of the main caregivers was lower, and parental treatment satisfaction was significantly higher in the IG than that in the WG.
","['children with diabetes', 'children with type 1 diabetes', '240 participants (1-16\u2009years), all using a CGM, were quasi-randomized by residence location to the intervention group (IG) or the', 'Virtual Outpatient Diabetes Clinic for Children and Youth (VIDIKI']",['waitlist-control group (WG'],"['diabetes burden and increased treatment satisfaction', 'parental treatment satisfaction']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",240.0,0.04624,"The diabetes burden of the main caregivers was lower, and parental treatment satisfaction was significantly higher in the IG than that in the WG.
","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'von Sengbusch', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetology, University Medical Center Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Eisemann', 'Affiliation': 'Institute for Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Mueller-Godeffroy', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetology, University Medical Center Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Hannover Medical School, Medical Psychology, Hannover, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Doerdelmann', 'Affiliation': 'Institute for Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Alev', 'Initials': 'A', 'LastName': 'Erdem', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetology, University Medical Center Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Menrath', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetology, University Medical Center Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bokelmann', 'Affiliation': 'Department of Pediatrics Kiel, University Medical Centre Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Krasmann', 'Affiliation': 'Department of Pediatrics Kiel, University Medical Centre Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Kaczmarczyk', 'Affiliation': 'Department of Pediatrics, General Hospital Kiel, Kiel, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Bertram', 'Affiliation': 'Department of Pediatrics, General Hospital Kiel, Kiel, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Hiort', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetology, University Medical Center Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Katalinic', 'Affiliation': 'Institute for Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Fabian S', 'Initials': 'FS', 'LastName': 'Frielitz', 'Affiliation': 'Institute for Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.'}]",Pediatric diabetes,['10.1111/pedi.13133']
3063,33010094,"Homeopathic Treatment as an Add-On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non-Small Cell Lung Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Three-Arm, Multicenter Study.","LESSONS LEARNED
Conventional medicine and homeopathy work well together. Quality of life improves with additive homeopathy in patients with non-small cell lung cancer (NSCLC). Survival improves with additive homeopathy in patients with NSCLC.
BACKGROUND
Patients with advanced non-small cell lung cancer (NSCLC) have limited treatment options. Alongside conventional anticancer treatment, additive homeopathy might help to alleviate side effects of conventional therapy. The aim of the present study was to investigate whether additive homeopathy might influence quality of life (QoL) and survival in patients with NSCLC.
METHODS
In this prospective, randomized, placebo-controlled, double-blind, three-arm, multicenter, phase III study, we evaluated the possible effects of additive homeopathic treatment compared with placebo in patients with stage IV NSCLC, with respect to QoL in the two randomized groups and survival time in all three groups. Treated patients visited the outpatients' centers every 9 weeks: 150 patients with stage IV NSCLC were included in the study; 98 received either individualized homeopathic remedies (n = 51) or placebo (n = 47) in a double-blinded fashion; and 52 control patients without any homeopathic treatment were observed for survival only. The constituents of the different homeopathic remedies were mainly of plant, mineral, or animal origin. The remedies were manufactured by stepwise dilution and succussion, thereby preparing stable Good Manufacturing Practice grade formulations.
RESULTS
QoL as well as functional and symptom scales showed significant improvement in the homeopathy group when compared with placebo after 9 and 18 weeks of homeopathic treatment (p < .001). Median survival time was significantly longer in the homeopathy group (435 days) versus placebo (257 days; p = .010) as well as versus control (228 days; p < .001). Survival rate in the homeopathy group differed significantly from placebo (p = .020) and from control (p < .001).
CONCLUSION
QoL improved significantly in the homeopathy group compared with placebo. In addition, survival was significantly longer in the homeopathy group versus placebo and control. A higher QoL might have contributed to the prolonged survival. The study suggests that homeopathy positively influences not only QoL but also survival. Further studies including other tumor entities are warranted.",2020,"Survival rate in the homeopathy group differed significantly from placebo (p = .020) and from control (p < .001).
","['NSCLC patients', '150 patients with stage IV NSCLC were included in the study; 98 received either', 'Treated patients visited the university teaching hospital every 9\u2009weeks', 'patients with non-small cell lung cancer (NSCLC', 'patients with stage IV NSCLC, with respect to QoL', 'Patients with advanced non-small cell lung cancer (NSCLC', 'Patients with Non-Small Cell Lung Cancer']","['individualized homeopathic remedies', 'placebo', 'additive homeopathic treatment', 'additive homeopathy', 'Placebo']","['quality of life (QoL) and survival', 'Median survival time', 'survival time', 'functional and symptom scales', 'Survival', 'Survival rate', 'Quality of life', 'survival', 'Quality of Life and Prolong Survival']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0684199', 'cui_str': 'Homeopathic therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442796', 'cui_str': 'Additive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]",150.0,0.518239,"Survival rate in the homeopathy group differed significantly from placebo (p = .020) and from control (p < .001).
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Frass', 'Affiliation': 'Medical\u2009University of Vienna, Department of Medicine I, Clinical Division of Oncology and Institute for Homeopathic Research, Vienna, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lechleitner', 'Affiliation': 'Hospital of Lienz, Department of Medicine, Lienz, Austria.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Gründling', 'Affiliation': 'General Practitioner, Enns, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pirker', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Respiratory Oncology Unit, Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Grasmuk-Siegl', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Respiratory Oncology Unit, Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Domayer', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Respiratory Oncology Unit, Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Hochmair', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Respiratory Oncology Unit, Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Gaertner', 'Affiliation': 'Institute of Complementary Medicine, University of Bern, Inselspital, Bern, Switzerland.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Duscheck', 'Affiliation': 'Medical University of Vienna, Department of Medicine I, Clinical Division of Oncology, Vienna, Austria.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Muchitsch', 'Affiliation': 'Austrian Chamber of Pharmacists, Department Vienna, HomResearch, Interdisciplinary Homeopathic Research Group, Vienna, Austria.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Marosi', 'Affiliation': 'Medical University of Vienna, Department of Medicine I, Clinical Division of Oncology, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schumacher', 'Affiliation': 'Elisabethinenspital, Department of Medicine, Linz, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Zöchbauer-Müller', 'Affiliation': 'Medical University of Vienna, Department of Medicine I, Clinical Division of Oncology, Vienna, Austria.'}, {'ForeName': 'Raj K', 'Initials': 'RK', 'LastName': 'Manchanda', 'Affiliation': 'Central Council for Research in Homeopathy, Ministry of AYUSH, Government of India and LMHI, West Delhi, Delhi, India.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schrott', 'Affiliation': 'StatistikAmbulanz, Consulting Company, Leobendorf, Austria.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Burghuber', 'Affiliation': 'Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for Lung Health, Otto Wagner Hospital and Sigmund Freud University, Medical School, Vienna, Austria.'}]",The oncologist,['10.1002/onco.13548']
3064,33010116,Ingestion of an exogenous ketone monoester improves the glycemic response during oral glucose tolerance test in individuals with impaired glucose tolerance: A cross-over randomized trial.,"AIMS/INTRODUCTION
As a low-carbohydrate diet and the use of sodium-glucose transporter-2 inhibitors are both known to increase D-beta-hydroxybutyrate levels, the effect of these levels on glucose metabolism has attracted attention. We investigated the acute effects of ketone monoester (KM) ingestion on blood glucose levels during the 75-g oral glucose tolerance test (OGTT) in participants with impaired glucose tolerance.
MATERIALS AND METHODS
Nine Japanese adults aged 48-62 years (4 men, 5 women) with impaired glucose tolerance participated in this study. After participants fasted overnight, we carried out OGTT for 180 min with and without KM ingestion on two separate days in a randomized cross-over design. We compared the area under the curve (AUC) of D-beta-hydroxybutyrate, glucose, insulin, C-peptide, glucagon and free fatty acids during OGTT.
RESULTS
The AUC of D-beta-hydroxybutyrate during OGTT was significantly higher with KM than without KM (KM 5995.3 ± 1257.1 mmol/L·h; without KM 116.1 ± 33.9 mmol/L·h, P < 0.0001), and the AUC of glucose with KM was significantly lower than that without KM (KM 406.6 ± 70.6 mg/dL·h; without KM 483.2 ± 74.3 mg/dL·h, P < 0.0001). This improved glucose excursion was associated with enhanced AUC of insulin during the first half (0-90 min) of OGTT, even though the AUC of C-peptide during this period was unchanged. In contrast, the AUC of insulin, C-peptide, glucagon and free fatty acids during 180 min of OGTT were similar in both conditions.
CONCLUSION
The ingestion of KM decreased the AUC of glucose during 75-g OGTT in Japanese individuals with impaired glucose tolerance, and the mechanism might involve elevated levels of circulating early phase insulin.",2020,"The AUC-βHB during OGTT was significantly higher with KM than without KM (KM, 5995.3 ± 1257.1 mmo/L h; without KM, 116.1 ± 33.9 mmo/L·h , P<0.0001), and the AUC-glucose with KM was significantly lower than that without KM (KM, 406.6 ± 70.6 mg/dL h; without KM, 483.2 ± 74.3 mg/dL·h, P<0.0001).","['Subjects with Impaired Glucose Tolerance', 'Nine Japanese adults aged 48-62 years (4 male, 5 female) with IGT participated in this study', 'participants with impaired glucose tolerance (IGT']","['75-g oral glucose tolerance testing (OGTT', 'ketone monoester (KM) ingestion', 'Exogenous Ketone Monoester']","['ingestion of KM decreased AUC-glucose', 'glucose excursion', 'blood glucose levels', 'AUC-glucose with KM', 'enhanced AUC-insulin', 'Glycemic Response', 'AUC-insulin, C-peptide, glucagon, and FFA', 'area under the curve (AUC) of βHB, glucose, insulin, C-peptide, glucagon, and free fatty acids (FFA']","[{'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205101', 'cui_str': 'External'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}]",9.0,0.0503961,"The AUC-βHB during OGTT was significantly higher with KM than without KM (KM, 5995.3 ± 1257.1 mmo/L h; without KM, 116.1 ± 33.9 mmo/L·h , P<0.0001), and the AUC-glucose with KM was significantly lower than that without KM (KM, 406.6 ± 70.6 mg/dL h; without KM, 483.2 ± 74.3 mg/dL·h, P<0.0001).","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakagata', 'Affiliation': 'Sportology Center, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Tamura', 'Affiliation': 'Sportology Center, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hideyoshi', 'Initials': 'H', 'LastName': 'Kaga', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Motonori', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Someya', 'Affiliation': 'Sportology Center, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Satoh', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Ryuzo', 'Initials': 'R', 'LastName': 'Kawamori', 'Affiliation': 'Sportology Center, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Sportology Center, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13423']
3065,33010473,Patient navigation among recently hospitalized smokers to promote tobacco treatment: Results from a randomized exploratory pilot study.,"INTRODUCTION
Adding screening for health-related social needs to tobacco treatment interventions initiated during hospitalizations may improve intervention effectiveness among vulnerable populations. Our objective was to examine the effect the acceptability and feasibility of a intervention in which a patient navigator screens for and addresses social needs to increase receipt of smoking cessation medication among recently hospitalized smokers at a safety-net hospital.
METHODS
In a two-group randomized exploratory pilot study, we assigned hospitalized smokers to either the Enhanced Traditional Control (ETC) group (list of smoking cessation resources) or ETC + Patient Navigation (up to 10 h of navigation over a 3-month period, in which a navigator screens for and addresses health-related social needs). We assessed socio-demographics, smoking-related variables, and process data.
RESULTS
Of 171 individuals screened, 44 (26%) were enrolled. Participants (mean age = 54.9 years, 61.4% non-Hispanic black, 68.2% high school education or less) smoked a mean of 11.4 cigarettes/day. 20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group. 11 participants (47.8%) in the ETC + Patient Navigation group received the minimum intervention dose (completion of the social needs screener and at least one counseling session). Barriers to navigation were participants' medical illness and difficulty connecting with participants.
CONCLUSIONS
Although nearly half of hospitalized smokers receiving support from a patient navigator received a prescription for a smoking cessation medication, the percentage did not differ by study arm. Refinement of the protocol to coordinate with hospital-wide tobacco treatment and social needs screening initiatives is needed.",2020,"20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group.","['54.9\xa0years, 61.4% non-Hispanic black, 68.2% high school education or less) smoked a mean of 11.4 cigarettes/day', 'Participants (mean age\xa0', '20 participants', 'Of 171 individuals screened, 44 (26%) were enrolled']","['ETC\xa0+\xa0Patient Navigation group', 'minimum intervention dose (completion of the social needs screener and at least one counseling session', 'Enhanced Traditional Control (ETC) group (list of smoking cessation resources) or ETC\xa0+\xa0Patient Navigation (up to 10\xa0h of navigation']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0547043', 'cui_str': 'Up'}]",[],,0.0505863,"20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Quintiliani', 'Affiliation': 'Boston University, School of Medicine, Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States. Electronic address: Lmquinti@bu.edu.'}, {'ForeName': 'Hasmeena', 'Initials': 'H', 'LastName': 'Kathuria', 'Affiliation': 'Boston University, School of Medicine, The Pulmonary Center, Boston Medical Center, Section of Pulmonary, Allergy, Sleep & Critical Care Medicine, 72 East Concord St., Boston, MA 02118, United States.'}, {'ForeName': 'Ve', 'Initials': 'V', 'LastName': 'Truong', 'Affiliation': 'Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Murillo', 'Affiliation': 'Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Borrelli', 'Affiliation': 'Boston University, Henry M. Goldman School of Dental Medicine, Center for Behavioral Science Research, 560 Harrison Ave., Boston, MA 02118, United States.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'Boston University, School of Public Health, 801 Massachusetts Ave., Crosstown CT453, Boston, MA 02118, United States.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Lasser', 'Affiliation': 'Boston University, School of Medicine, Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106659']
3066,33010491,The incidence of persistent postoperative opioid use among U.S. veterans: A national study to identify risk factors.,"OBJECTIVE
To calculate the incidence and identify the predictors of persistent postoperative opioid use at different postoperative days.
BACKGROUND DATA
A subset of surgical patients continues to use long-term opioids. The importance of the risk factors at different postoperative days is not known.
DESIGN
A historical cohort.
SETTING
Postoperative period.
PATIENTS
Opioid-naive U.S. veterans.
INTERVENTIONS
The surgical group had any one of 19 common invasive procedures. The control group is a 10% random sample. Each control was randomly assigned a surgery date.
MEASUREMENTS
The outcomes were the presence of persistent opioid use as determined by continued filling of prescriptions for opioids on postoperative days 90, 180, 270, and 365.
MAIN RESULTS
A total of 183,430 distinct surgical cases and 1,318,894 controls were identified. 1.0% of the surgical patients were using opioids at 90 days, 0.6% at 180 days, 0.4% at 270 days, and 0.1% at 365 days after the surgery. Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls. In risk factor analysis, being male and single were associated with persistent opioid use at earlier time points (90 and 180 days), while hepatitis C and preoperative benzodiazepine use were associated with persistent opioid use at later time points (270 and 365 days).
CONCLUSIONS
Many surgeries or invasive procedures are associated with an increased risk of persistent postoperative opioid use. The postoperative period is dynamic and the risk factors change with time.",2020,"Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls.","['Opioid-naive U.S. veterans', 'U.S. veterans', '183,430 distinct surgical cases and 1,318,894 controls were identified']",[],['postoperative persistent opioid use'],"[{'cui': 'C1739422', 'cui_str': 'Opioid naive'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",183430.0,0.0682083,"Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls.","[{'ForeName': 'Khodadad', 'Initials': 'K', 'LastName': 'Namiranian', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Department of Anesthesiology, University of Maryland, Baltimore, MD, United States of America; VA Central California Health Care System, Fresno, CA, United States of America. Electronic address: khodadad.x.namiranian@kp.org.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Siglin', 'Affiliation': 'School of Medicine, University of Maryland, Baltimore, MD, United States of America.'}, {'ForeName': 'John David', 'Initials': 'JD', 'LastName': 'Sorkin', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Baltimore VA Medical Center Geriatric Research, Education and Clinical Center, VA Maryland Health Care System, Baltimore, MD, United States of America; Division of Gerontology and Geriatric Medicine, University of Maryland, Baltimore, MD, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110079']
3067,33010590,Plantar pressure distribution and wearing characteristics of three forefoot offloading shoes in healthy adult subjects.,"Forefoot offloading shoes are used to reduce pressure on specific regions of the foot. Aim of the pressure reduction is to aid healing of the soft and bony tissues and prevent complications by treating foot disorders. A great variety of forefoot offloading shoes are available. In a first step to investigate the appropriate use of these footwear in orthopedic settings, we studied plantar pressure distribution and wearing characteristics of three forefoot offloading shoes namely the Mailand, OrthoWedge and Podalux in a healthy population. Twenty subjects walked in a randomized order wearing three forefoot offloading shoes and a reference shoe for six minutes. The Pedar system was used to measure the pressure in 7 regions. Peak pressure and pressure time integral were analyzed as measures of pressure distribution. Furthermore, wearing characteristics were addressed using a Numeric Rating Scale. Pressure distribution and wearing characteristics of the forefoot offloading shoes were compared to a reference shoe. The Mailand and OrthoWedge shoes significantly reduced peak pressure with more than 80% under the hallux and more than 45% under MTH1 (p<.001). The Podalux did not show significant peak pressure reduction under the forefoot compared to the reference shoe. Under the lesser toes, the MTH4-5 region and heel region the Podalux shoe showed even a significant increase in peak pressure (p=.001). Looking at wearing characteristics, the Podalux and reference shoe scored significantly better than the other two forefoot offloading shoes (p<.01). In this study the differences between different forefoot offloading shoes was assessed. The Mailand and OrthoWedge shoes gave the best pressure reduction in the forefoot but are less comfortable in use. The Podalux rocker shoe showed opposite results. Next step is a patient study to compare our results in a patient population.",2020,"Looking at wearing characteristics, the Podalux and reference shoe scored significantly better than the other two forefoot offloading shoes (p<.01).","['Twenty subjects walked', 'healthy adult subjects']",[],"['Numeric Rating Scale. Pressure distribution and wearing characteristics of the forefoot offloading shoes', 'Plantar pressure distribution and wearing characteristics', 'Peak pressure and pressure time integral', 'peak pressure reduction', 'peak pressure']","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",20.0,0.0330946,"Looking at wearing characteristics, the Podalux and reference shoe scored significantly better than the other two forefoot offloading shoes (p<.01).","[{'ForeName': 'M C H W', 'Initials': 'MCHW', 'LastName': 'Fuchs', 'Affiliation': 'Department of Orthopaedic Surgery, Catharina Hospital Eindhoven, Postbus 1350, 5602 ZA Eindhoven, The Netherlands; Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands. Electronic address: thijn.fuchs@catharinaziekenhuis.nl.'}, {'ForeName': 'M M N', 'Initials': 'MMN', 'LastName': 'Hermans', 'Affiliation': 'Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands.'}, {'ForeName': 'H J J', 'Initials': 'HJJ', 'LastName': 'Kars', 'Affiliation': 'Fontys Hogeschool Eindhoven, Allied Health Professions, Dominee Theodor Fliednerstraat 2, 5631 BN Eindhoven, The Netherlands.'}, {'ForeName': 'J G E', 'Initials': 'JGE', 'LastName': 'Hendriks', 'Affiliation': 'Department of Orthopaedic Surgery, Catharina Hospital Eindhoven, Postbus 1350, 5602 ZA Eindhoven, The Netherlands; Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'van der Steen', 'Affiliation': 'Department of Orthopaedic Surgery, Catharina Hospital Eindhoven, Postbus 1350, 5602 ZA Eindhoven, The Netherlands; Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands.'}]","Foot (Edinburgh, Scotland)",['10.1016/j.foot.2020.101744']
3068,33010649,"The effect of a stress ball on stress, vital signs and patient comfort in hemodialysis patients: A randomized controlled trial.","OBJECTIVE
In this study, an investigation was made of the effect of the use of a stress ball, a method of distraction-attracting the attention elsewhere - on stress, vital signs andcomfort levels in hemodialysis patients.
METHODS
This randomized, controlled experimental study, between July 2019 and September 2019 was carried out in a dialysis unit in the inner regions of Turkey. The study was conducted with 45 patients (23 experiments, 22 controls) who were receiving hemodialysis treatment. The experimental group were asked to squeeze a stress ball for approximately 10-15 min throughout eight successive dialysis sessions. The data were obtained with an Individual Description Form, the Distress Thermometer and the Hemodialysis Comfort Scale.
RESULTS
At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05). However, while the stress score of the experimental group decreased significantly, the stress score of the control groups increased (p < 0.05).
CONCLUSION
This study shows that although the use of the stress ball did not affect vital signs and comfort in hemodialysis patients, it had a positive effect on stress.",2020,"At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05).","['45 patients (23 experiments, 22 controls) who were receiving hemodialysis treatment', 'hemodialysis patients', 'between July 2019 and September 2019 was carried out in a dialysis unit in the inner regions of Turkey']",[],"['stress score', 'vital signs and comfort levels', 'stress, vital signs and patient comfort']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1629858', 'cui_str': 'Dialysis unit'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]",[],"[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}]",,0.0236922,"At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05).","[{'ForeName': 'Kadriye Sayin', 'Initials': 'KS', 'LastName': 'Kasar', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Aksaray University, Aksaray, Turkey. Electronic address: kadriyekasar@aksaray.edu.tr.'}, {'ForeName': 'Saadet', 'Initials': 'S', 'LastName': 'Erzincanli', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Aksaray University, Aksaray, Turkey. Electronic address: saadeterzincanli@hotmail.com.'}, {'ForeName': 'Nesat Tolga', 'Initials': 'NT', 'LastName': 'Akbas', 'Affiliation': 'Dialysis Unit, Training and Research Hospital, Aksaray University, Aksaray, Turkey. Electronic address: takbas@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101243']
3069,33007909,Exploring the Benefits of Virtual Reality-Assisted Therapy Following Cognitive-Behavioral Therapy for Auditory Hallucinations in Patients with Treatment-Resistant Schizophrenia: A Proof of Concept.,"BACKGROUND
Combining cognitive behavioral therapy (CBT) for psychosis with another psychosocial intervention comprising virtual reality (VR)-assisted therapy (VRT) may improve targeted outcomes in treatment-resistant schizophrenia patients.
METHODS
Ten participants having followed CBT were part of our comparative clinical trial comparing VRT to CBT and were selected at the end of the study as they desired to continue to achieve improvements with VRT (CBT + VRT). Clinical assessments were administered before/after treatments and at follow-ups. Changes in outcomes were examined using linear mixed-effects models. To gain a more in depth understanding on CBT + VRT, therapists' notes, and open interviews on a sub-group of patients were qualitatively analyzed.
RESULTS
Findings showed that the sequence of both interventions was appreciated by all patients. Several significant improvements were found throughout time points on auditory verbal hallucinations, beliefs about voices, depressive symptoms, symptoms of schizophrenia and quality of life. Although most of these improvements were in similar range to those observed in our comparative trial, effects of CBT + VRT on depressive symptoms and symptoms of schizophrenia were larger than those found for either intervention alone.
CONCLUSION
This proof of concept is the first to merge gold-standard CBT with VRT for treatment refractory voices and to suggest a certain synergistic effect.",2020,"Several significant improvements were found throughout time points on auditory verbal hallucinations, beliefs about voices, depressive symptoms, symptoms of schizophrenia and quality of life.","['Ten participants having followed CBT were part of our comparative clinical trial comparing VRT to CBT', 'Patients with Treatment-Resistant Schizophrenia']","['cognitive behavioral therapy (CBT', 'CBT + VRT', 'virtual reality (VR)-assisted therapy (VRT', 'VRT (CBT + VRT', 'Virtual Reality-Assisted Therapy Following Cognitive-Behavioral Therapy']","['auditory verbal hallucinations, beliefs about voices, depressive symptoms, symptoms of schizophrenia and quality of life', 'Auditory Hallucinations', 'depressive symptoms and symptoms of schizophrenia']","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3544321', 'cui_str': 'Treatment-resistant schizophrenia'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C2721589', 'cui_str': 'Verbal hallucinations'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0233762', 'cui_str': 'Auditory hallucinations'}]",,0.0124199,"Several significant improvements were found throughout time points on auditory verbal hallucinations, beliefs about voices, depressive symptoms, symptoms of schizophrenia and quality of life.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dellazizzo', 'Affiliation': 'Research Center of the Institut Universitaire en Santé Mentale de Montréal, 7331 Hochelaga, Montreal, QC H1N 3V2, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Potvin', 'Affiliation': 'Research Center of the Institut Universitaire en Santé Mentale de Montréal, 7331 Hochelaga, Montreal, QC H1N 3V2, Canada.'}, {'ForeName': 'Kingsada', 'Initials': 'K', 'LastName': 'Phraxayavong', 'Affiliation': 'Services et Recherches Psychiatriques AD, Montreal, QC, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Dumais', 'Affiliation': 'Research Center of the Institut Universitaire en Santé Mentale de Montréal, 7331 Hochelaga, Montreal, QC H1N 3V2, Canada.'}]",Journal of clinical medicine,['10.3390/jcm9103169']
3070,33007918,Weight Reduction by the Low-Insulin-Method-A Randomized Controlled Trial.,"Continuous high insulin levels are associated with weight gain and lead to cardiometabolic diseases. Therefore, we have developed the Low-Insulin-Method and integrated it into the multi-component, occupational healthcare program SHAPE-AND-MOTION-Medical-Accompanied-Slimming (SAMMAS) to reduce daily insulin levels for long-term weight reduction in overweight or obesity. Employees were randomized into a starting intervention group (SI, n = 15) or waiting list control group (WL, n = 15). SAMMAS consisted of group-based seminars, low-carbohydrate nutrition including formula diet, continuous glucose monitoring, telemetric monitoring, and telemedical coaching. Both groups received telemetric devices at baseline. Intention-to-treat analyses were performed after 12, 26, and 52 weeks. The estimated treatment difference in weight reduction after 12 weeks, which is the primary endpoint of the study, showed a pronounced effect in favour of SI (-6.3 kg with (95% confidence interval) (-7.4; -4.5) ( p < 0.001)) after 12 weeks. Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour (all p < 0.05) in the within-group analysis, while WL did not. After 26 and 52 weeks, weight reduction could be maintained in the whole group (both groups together) by -6.7 kg (-9.5; -3.8) ( p < 0.001) and -6.1 kg (-9.2; -2.7) ( p < 0.01). SAMMAS supports clinically relevant weight reduction and long-term weight loss maintenance in individuals with overweight or obesity.",2020,"Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour (all p < 0.05) in the within-group analysis, while WL did not.",['individuals with overweight or obesity'],"['low-carbohydrate nutrition including formula diet, continuous glucose monitoring, telemetric monitoring, and telemedical coaching', 'starting intervention group (SI, n = 15) or waiting list control']","['weight gain', 'weight reduction', 'favour of SI', 'Weight Reduction', 'Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",,0.0621233,"Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour (all p < 0.05) in the within-group analysis, while WL did not.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Röhling', 'Affiliation': 'West-German Centre of Diabetes and Health, Dusseldorf Catholic Hospital Group, 40591 Dusseldorf, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': 'Hochschule Niederrhein, University of Applied Sciences, 41065 Mönchengladbach, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Ellinger', 'Affiliation': 'Hochschule Niederrhein, University of Applied Sciences, 41065 Mönchengladbach, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schreiber', 'Affiliation': 'Psychiatric-Psychotherapeutic Day-Care Hospital, Dusseldorf Catholic Hospital Group, 40591 Dusseldorf, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Martin', 'Affiliation': 'West-German Centre of Diabetes and Health, Dusseldorf Catholic Hospital Group, 40591 Dusseldorf, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Kempf', 'Affiliation': 'West-German Centre of Diabetes and Health, Dusseldorf Catholic Hospital Group, 40591 Dusseldorf, Germany.'}]",Nutrients,['10.3390/nu12103004']
3071,33009192,Postoperative pain therapy with hydromorphone; comparison of patient-controlled analgesia with target-controlled infusion and standard patient-controlled analgesia: A randomised controlled trial.,"BACKGROUND
The challenge of managing acute postoperative pain is the well tolerated and effective administration of analgesics with a minimum of side effects. The standard therapeutic approach is patient-controlled analgesia (PCA) with systemic opioids. To overcome problems of oscillating opioid concentrations, we studied patient-controlled analgesia by target-controlled infusion (TCI-PCA) as an alternative.
OBJECTIVE
To compare efficacy, safety and side effects of standard PCA with TCI-PCA for postoperative pain therapy with hydromorphone.
DESIGN
Single-blinded, randomised trial.
SETTING
University Hospital, Germany from December 2013 to April 2015.
PARTICIPANTS
Fifty adults undergoing cardiac surgery.
INTERVENTIONS
Postoperative pain therapy on the ICU was managed with intravenous (i.v.) hydromorphone and patients randomised to TCI-PCA with target plasma concentrations between 0.8 and 10 ng ml, or PCA with bolus doses of 0.2 mg. Pain was regularly assessed using the 11-point numerical rating scale (NRS). Blood pressure, heart rate, oxygen saturation and cardiac output were continuously monitored, and adverse events were registered throughout the study.
MAIN OUTCOME MEASURES
NRS pain ratings, hydromorphone doses, haemodynamic effects and side effects.
RESULTS
NRS pain ratings, total doses of hydromorphone and haemodynamic data did not differ significantly between TCI-PCA and PCA. The number of bolus doses during PCA was significantly higher than the number of target increases during TCI-PCA (P = 0.006). The number of negative requests was also significantly higher during PCA than during TCI-PCA (P = 0.02). The respiratory rate on the first postoperative morning was 25 ± 6 min during TCI-PCA, compared with 19 ± 4 min during PCA (P = 0.022). Nausea occurred in 30% after TCI-PCA and 24% after PCA (P = 0.46).
CONCLUSION
TCI-PCA was effective and well tolerated in acute postoperative pain management after cardiac surgery. Further studies are needed to evaluate this approach in clinical practice.
TRIAL REGISTRATION
EudraCT Number: 2013-002875-16, and ClinicalTrials.gov Identifier: NCT02035709.",2020,"RESULTS
NRS pain ratings, total doses of hydromorphone and haemodynamic data did not differ significantly between TCI-PCA and PCA.","['Fifty adults undergoing cardiac surgery', 'University Hospital, Germany from December 2013 to April 2015']","['Postoperative pain therapy', 'TCI-PCA', 'hydromorphone', 'standard PCA with TCI-PCA', 'patient-controlled analgesia with target-controlled infusion and standard patient-controlled analgesia']","['respiratory rate', 'NRS pain ratings, hydromorphone doses, haemodynamic effects and side effects', 'NRS pain ratings, total doses of hydromorphone and haemodynamic data', 'number of bolus doses during PCA', 'Pain', 'number of negative requests', '11-point numerical rating scale (NRS', 'Nausea', 'Blood pressure, heart rate, oxygen saturation and cardiac output']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}]",50.0,0.213414,"RESULTS
NRS pain ratings, total doses of hydromorphone and haemodynamic data did not differ significantly between TCI-PCA and PCA.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wehrfritz', 'Affiliation': 'From the Department of Anaesthesiology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany (AW, HI, TF, MK, SK, AW, JS, CJ).'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Ihmsen', 'Affiliation': ''}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Fuchte', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Kremer', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Weiß', 'Affiliation': ''}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Schüttler', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jeleazcov', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001360']
3072,33009228,"Randomized Controlled Crossover Trials of the Pharmacokinetics of PRC-063, a Novel Multilayer Extended-Release Formulation of Methylphenidate, in Healthy Adults.","PURPOSE/BACKGROUND
PRC-063 is a once-daily, extended-release oral formulation of methylphenidate hydrochloride developed to provide early and prolonged symptom improvement in patients with attention-deficit/hyperactivity disorder.
METHODS/PROCEDURES
We conducted 3 randomized, open-label crossover studies of the pharmacokinetics of PRC-063 in healthy, nonobese men and women aged 18 to 45 years. PRC-063 (100 mg/d) was compared with immediate-release methylphenidate (20 mg, 3 times daily) when administered on a single day under fasted and fed conditions and at steady state (day 5 of repeat dosing under fasted conditions). The pharmacokinetics of PRC-063 administered as capsule contents sprinkled on apple sauce, yoghurt, or ice cream were also investigated.
FINDINGS/RESULTS
PRC-063 demonstrated biphasic absorption, with 2 distinct peak plasma concentrations. Intake of a high-fat, high-calorie meal did not increase the peak plasma methylphenidate concentration (Cmax) or extent of absorption (area under the curve), however; it resulted in slower uptake versus a fasted state. During repeated dosing, steady state was reached with no further accumulation of methylphenidate from day 3. At steady state, PRC-063 gave higher evening and trough plasma methylphenidate levels than immediate-release methylphenidate (3 times daily). The pharmacokinetics of PRC-063 sprinkled on food were comparable to that of intact capsules. Reported adverse events (AEs) were consistent with the established safety profile of methylphenidate. There were no serious AEs, but 3 subjects discontinued the repeat-dosing study because of AEs assessed as possibly related to study treatment.
IMPLICATIONS/CONCLUSIONS
Our data indicate that PRC-063 can be taken with or without food or by sprinkling capsule contents on food.",2020,"At steady state, PRC-063 gave higher evening and trough plasma methylphenidate levels than immediate-release methylphenidate (3 times daily).","['Healthy Adults', 'patients with attention-deficit/hyperactivity disorder', 'healthy, nonobese men and women aged 18 to 45 years']","['immediate-release methylphenidate', 'Methylphenidate', 'PRC-063', 'methylphenidate', 'methylphenidate hydrochloride']","['peak plasma methylphenidate concentration (Cmax) or extent of absorption (area under the curve', 'biphasic absorption', 'trough plasma methylphenidate levels']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0700545', 'cui_str': 'Methylphenidate hydrochloride'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0524188', 'cui_str': 'Methylphenidate measurement'}]",,0.0604379,"At steady state, PRC-063 gave higher evening and trough plasma methylphenidate levels than immediate-release methylphenidate (3 times daily).","[{'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Katzman', 'Affiliation': 'From the START Clinic for Mood and Anxiety Disorders, Ontario.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Mattingly', 'Affiliation': 'Washington University School of Medicine, St Louis.'}, {'ForeName': 'Larry J', 'Initials': 'LJ', 'LastName': 'Klassen', 'Affiliation': 'Eden Mental Health Centre, Winkler, Manitoba, Canada.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Cataldo', 'Affiliation': 'Purdue Pharma L.P., Stamford, CT.'}, {'ForeName': 'Graeme A E', 'Initials': 'GAE', 'LastName': 'Donnelly', 'Affiliation': 'Purdue Pharma Canada, Pickering, Ontario, Canada.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001277']
3073,33009840,"Effect of a compassion fatigue resiliency program on nurses' professional quality of life, perceived stress, resilience: A randomized controlled trial.","AIMS
This study aimed to conduct a short- and long-term Compassion Fatigue Resiliency Program and compare its impact on nurses' professional quality of life, perceived stress, and resilience.
DESIGN
The research was conducted between January 2017 January 2019 as a randomized controlled trial.
METHODS
The sample comprised 125 oncology-haematology nurses randomly assigned to a Experimental I, Experimental II, or control group. The Compassion Fatigue Resiliency Program was conducted with the nurses as an intervention. Experimental I received a short-term program (5 hr per day for 2 days, 10 hr in total) while Experimental II received a long-term one (5 weeks, 2 hr per week, 10 hr in total). Measurements were obtained during pre- and post-test and at 3-, 6-, and 12-month follow-ups. Research hypotheses were analysed using multilevel models.
RESULTS
The results of multilevel model analyses showed there was no statistically significant difference between mean scores for compassion fatigue, burnout, perceived stress, and resilience of nurses in the short- or long-term groups or of those in the control group. Mean compassion satisfaction scores of nurses in the short- or long-term groups were significantly higher than those in the control group. Mean compassion satisfaction scores of nurses in the short- or long-term groups were significantly higher than the control group's pre-test mean after 6 and 12 months.
CONCLUSION
This study concluded that short- or long-term programs had no influence on compassion fatigue, burnout, perceived stress, and resilience; however, both programs positively affected compassion satisfaction. We recommend that further studies be conducted, which will help determine the effectiveness of new programs.
IMPACT
Caring for patients with cancer can generate work-related stress that can negatively affect oncology nurses' physical and emotional health, which could lead to compassion fatigue. The program provided nurses with an opportunity to improve their compassion satisfaction. Because there was no difference between both programs regarding mean compassion satisfaction scores, a short-term program may be preferred to encourage more participation among nurses. We also recommend further studies should be conducted that include environmental improvements along with the training programs. Trial registered at ClinicalTrials.gov (The name of the trial register: Effect of a Compassion Fatigue Resiliency Program; the clinical trial registration number: NCT04372303).",2020,"Mean compassion satisfaction scores of nurses in the short- or long-term groups were significantly higher than the control group's pre-test mean after 6 and 12 months.
","['The research was conducted between January 2017 January 2019', '125 oncology-haematology nurses', 'patients with cancer']","['Compassion Fatigue Resiliency Program', 'compassion fatigue resiliency program']","['compassion fatigue, burnout, perceived stress, and resilience', 'Mean compassion satisfaction scores of nurses', ""nurses' professional quality of life, perceived stress, and resilience"", ""nurses' professional quality of life, perceived stress, resilience"", 'mean scores for compassion fatigue, burnout, perceived stress, and resilience of nurses']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1274119', 'cui_str': 'Hematopathology'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.03058,"Mean compassion satisfaction scores of nurses in the short- or long-term groups were significantly higher than the control group's pre-test mean after 6 and 12 months.
","[{'ForeName': 'Tuğba', 'Initials': 'T', 'LastName': 'Pehlivan', 'Affiliation': 'Koç University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Perihan', 'Initials': 'P', 'LastName': 'Güner', 'Affiliation': 'Istanbul Bilgi University Faculty of Health Sciences, Istanbul, Turkey.'}]",Journal of advanced nursing,['10.1111/jan.14568']
3074,33009852,Relationship-based care model in paediatrics: A randomized controlled trial to implement the parents' perception of the quality of nursing care.,"AIM
To evaluate whether the application of the Relationship-based care model as a new treatment, called ""Take 5 min"", affects the level of anxiety, depression, and perceived quality of nursing care of parents of paediatric patients and the work satisfaction of the nursing staff.
DESIGN
Single-blind randomized controlled trial.
METHODS
The trial was performed from February-July 2016. The trial was conducted with one intervention (N = 101) and one control group (N = 90). Nurses applied the treatment named ""Take 5 Minutes"", which consisted of dedicating some short time (from 5 to 10 min) to the relationship with the parents using specifically designed communication strategies. The primary outcome was the evaluation of anxiety and depression of parents; the secondary was the parent perceived quality of nursing care.
RESULTS
In the experimental group, participants had a lower level of anxiety and depression and highlighted that the effect of the ""Take 5 Minutes"" was proportional to the initial seriousness of parents' anxiety and depression. Higher scores for the perception of the quality of care were given from the parents of the experimental group.
CONCLUSION
The ""Take 5 Minutes"" treatment offered to parents of paediatric patients demonstrated significant improvements in terms of their anxiety, depression, and perceived quality of nursing care.
IMPACT
Caregivers of paediatric patients are subject to psychological disorders such as depression and anxiety. The communication by the nursing community is of fundamental importance in the management of anxiety and depression in the caregivers of hospitalized patients. Caregivers who received the ""Take 5 Minutes"" treatment demonstrated a significant decrease in anxiety and depression compared with the control group caregivers. The perceived level of quality of nursing care showed a significant increase in the group of caregivers who received the T5M treatment. The RBC model does not require extra costs for health organizations and can be applied during the usual practice of care. Practices such as T5M could become part of paediatric patient care guidelines and nurses should be trained to apply them.
TRIAL REGISTRATION NUMBER
Padua Research: ID No. 10,034; ClinicalTrials.gov: ID No. NCT04199429.",2020,"Caregivers who received the ""Take 5 Minutes"" treatment demonstrated a significant decrease in anxiety and depression compared with the control group caregivers.","['caregivers of hospitalized patients', 'paediatrics']",[],"['anxiety, depression, and perceived quality of nursing care', 'level of quality of nursing care', 'evaluation of anxiety and depression of parents; the secondary was the parent perceived quality of nursing care', 'anxiety and depression']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.0344655,"Caregivers who received the ""Take 5 Minutes"" treatment demonstrated a significant decrease in anxiety and depression compared with the control group caregivers.","[{'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'De Barbieri', 'Affiliation': 'Department of Health Professions, University Hospital of Padova, Padova, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Sisti', 'Affiliation': 'Department of Biomolecular Sciences - Unit of Medical Statistic and Biometry, University of Urbino ""Carlo Bo"", Urbino, Italy.'}, {'ForeName': 'Achille', 'Initials': 'A', 'LastName': 'Di Falco', 'Affiliation': 'Unit of Health Professions Education and Development, Azienda Zero Veneto Region, Padova, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Galeazzo', 'Affiliation': 'Unit of Health Professions Education and Development, Azienda Zero Veneto Region, Padova, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Amatori', 'Affiliation': 'Department of Biomolecular Sciences - Unit of Medical Statistic and Biometry, University of Urbino ""Carlo Bo"", Urbino, Italy.'}, {'ForeName': 'Marco Bruno Luigi', 'Initials': 'MBL', 'LastName': 'Rocchi', 'Affiliation': 'Department of Biomolecular Sciences - Unit of Medical Statistic and Biometry, University of Urbino ""Carlo Bo"", Urbino, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Perilongo', 'Affiliation': ""Woman's and Child's Health Department, University of Padova, Padova, Italy.""}]",Journal of advanced nursing,['10.1111/jan.14585']
3075,33009898,"Direct anterior versus posterior approach for total hip arthroplasty: a multicentre, prospective, randomized clinical trial.","BACKGROUND
The ideal approach for a total hip arthroplasty (THA) would be kind to soft tissues, have the lowest complication rates and be easily reproducible. Although there have been several attempts to find the best approach for THA in the last decade, a definitive answer has not been found. We performed a prospective study to compare the direct anterior and posterior approaches for THA in terms of hospital length of stay, functional outcome, pain, implant position, complications and surgical time.
METHODS
A prospective, randomized, multicentre clinical study was conducted between February 2011 and July 2013, with an average follow-up of 55 months. Patients undergoing the direct anterior or posterior approach for THA were enrolled. Hospital length of stay, surgical time and complications were documented. The Harris Hip Score and visual analogue scale were used to monitor functional outcome and pain until 5 years postoperatively. Radiologic analysis was used to assess implant position.
RESULTS
Fifty-five patients (28 undergoing the direct anterior approach, 27 undergoing the posterior approach) were enrolled in this study. Length of stay, functional outcome, pain, implant position and complications were similar for the 2 approaches. There was a trend toward a better functional outcome for patients who underwent the direct anterior approach in the first 3 months postoperatively, with a peak at 4 weeks (Harris Hip Score 76.7 v. 68.7; p = 0.08). Average surgical time for the direct anterior approach was significantly longer (69.9 v. 45.7 min; p = 0.002).
CONCLUSION
The direct anterior approach for THA appears to be a safe and effective option. However, there is no significant difference in hospital length of stay or postoperative recovery between the 2 approaches.
CLINICAL TRIAL REGISTRATION
Clinicaltrials.gov, no. NCT03673514.",2020,"Average surgical time for the direct anterior approach was significantly longer (69.9 v. 45.7 min; p = 0.002).
","['Patients undergoing the direct anterior or posterior approach for THA were enrolled', 'Fifty-five patients (28 undergoing the direct anterior approach, 27 undergoing the posterior approach', 'February 2011 and July 2013, with an average follow-up of 55 months', 'total hip arthroplasty']",['Direct anterior versus posterior approach'],"['Hospital length of stay, surgical time and complications', 'Harris Hip Score and visual analogue scale', 'functional outcome', 'Average surgical time', 'hospital length of stay or postoperative recovery', 'hospital length of stay, functional outcome, pain, implant position, complications and surgical time', 'Length of stay, functional outcome, pain, implant position and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",27.0,0.0419216,"Average surgical time for the direct anterior approach was significantly longer (69.9 v. 45.7 min; p = 0.002).
","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Moerenhout', 'Affiliation': 'From the Department of Orthopaedics and Traumatology, Lausanne University Hospital, Lausanne, Switzerland (Moerenhout); Division of Orthopedic Surgery, Department of Surgery, Hôpital Sacré-Coeur de Montréal, Montreal, Que. (Moerenhout, Derome, Laflamme, Leduc, Benoit); and Department of Orthopedic Surgery, Hull Hospital, Gatineau, Que. (Gaspard).'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Derome', 'Affiliation': 'From the Department of Orthopaedics and Traumatology, Lausanne University Hospital, Lausanne, Switzerland (Moerenhout); Division of Orthopedic Surgery, Department of Surgery, Hôpital Sacré-Coeur de Montréal, Montreal, Que. (Moerenhout, Derome, Laflamme, Leduc, Benoit); and Department of Orthopedic Surgery, Hull Hospital, Gatineau, Que. (Gaspard).'}, {'ForeName': 'G Yves', 'Initials': 'GY', 'LastName': 'Laflamme', 'Affiliation': 'From the Department of Orthopaedics and Traumatology, Lausanne University Hospital, Lausanne, Switzerland (Moerenhout); Division of Orthopedic Surgery, Department of Surgery, Hôpital Sacré-Coeur de Montréal, Montreal, Que. (Moerenhout, Derome, Laflamme, Leduc, Benoit); and Department of Orthopedic Surgery, Hull Hospital, Gatineau, Que. (Gaspard).'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Leduc', 'Affiliation': 'From the Department of Orthopaedics and Traumatology, Lausanne University Hospital, Lausanne, Switzerland (Moerenhout); Division of Orthopedic Surgery, Department of Surgery, Hôpital Sacré-Coeur de Montréal, Montreal, Que. (Moerenhout, Derome, Laflamme, Leduc, Benoit); and Department of Orthopedic Surgery, Hull Hospital, Gatineau, Que. (Gaspard).'}, {'ForeName': 'Henry S', 'Initials': 'HS', 'LastName': 'Gaspard', 'Affiliation': 'From the Department of Orthopaedics and Traumatology, Lausanne University Hospital, Lausanne, Switzerland (Moerenhout); Division of Orthopedic Surgery, Department of Surgery, Hôpital Sacré-Coeur de Montréal, Montreal, Que. (Moerenhout, Derome, Laflamme, Leduc, Benoit); and Department of Orthopedic Surgery, Hull Hospital, Gatineau, Que. (Gaspard).'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Benoit', 'Affiliation': 'From the Department of Orthopaedics and Traumatology, Lausanne University Hospital, Lausanne, Switzerland (Moerenhout); Division of Orthopedic Surgery, Department of Surgery, Hôpital Sacré-Coeur de Montréal, Montreal, Que. (Moerenhout, Derome, Laflamme, Leduc, Benoit); and Department of Orthopedic Surgery, Hull Hospital, Gatineau, Que. (Gaspard).'}]",Canadian journal of surgery. Journal canadien de chirurgie,[]
3076,33011188,The influence of linguistic information on cortical tracking of words.,"Speech is a complex sound sequence that has rich acoustic and linguistic structures. Recent studies have suggested that low-frequency cortical activity can track linguistic units in speech, such as words and phrases, on top of low-level acoustic features. Here, with an artificial word learning paradigm, we investigate how different aspects of linguistic information, e.g., phonological, semantic, and orthographic information, modulate cortical tracking of words. Participants are randomly assigned to the experimental group or the control group. Both groups listen to speech streams composed of trisyllabic artificial words or trisyllabic real words. Participants in the experimental group explicitly learn different types of linguistic information of artificial words (phonological, phonological + semantic, or phonological + orthographic information), while participants in the control group do not explicitly learn the words. Electroencephalographic (EEG) data from the control group reveal weaker cortical tracking of artificial words than real words. However, when comparing the experimental and control groups, we find that explicit learning significantly improves neural tracking of artificial words. After explicit learning, cortical tracking of artificial words is comparable to real words, regardless of the training conditions. These results suggest training facilitates neural tracking of words and emphasize the basic role phonological information played in sequential grouping.",2020,Electroencephalographic (EEG) data from the control group reveal weaker cortical tracking of artificial words than real words.,[],"['linguistic information of artificial words (phonological, phonological + semantic, or phonological + orthographic information), while participants in the control group do not explicitly learn the words', 'explicit learning']",['neural tracking of artificial words'],[],"[{'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]",,0.0216826,Electroencephalographic (EEG) data from the control group reveal weaker cortical tracking of artificial words than real words.,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory for Biomedical Engineering of Ministry of Education, College of Biomedical Engineering and Instrument Sciences, Zhejiang University, Hangzhou, 310027, China.'}, {'ForeName': 'Peiqing', 'Initials': 'P', 'LastName': 'Jin', 'Affiliation': 'Key Laboratory for Biomedical Engineering of Ministry of Education, College of Biomedical Engineering and Instrument Sciences, Zhejiang University, Hangzhou, 310027, China.'}, {'ForeName': 'Nai', 'Initials': 'N', 'LastName': 'Ding', 'Affiliation': 'Key Laboratory for Biomedical Engineering of Ministry of Education, College of Biomedical Engineering and Instrument Sciences, Zhejiang University, Hangzhou, 310027, China; Research Center for Advanced Artificial Intelligence Theory, Zhejiang Lab, Hangzhou, 311121, China. Electronic address: ding_nai@zju.edu.cn.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107640']
3077,33019646,"Synergistic Effects of Regular Walking and Alkaline Electrolyzed Water on Decreasing Inflammation and Oxidative Stress, and Increasing Quality of Life in Individuals with Type 2 Diabetes: A Community Based Randomized Controlled Trial.","Alkaline electrolyzed water (AEW) and walking are strongly recommended for ameliorating oxidative stress and inflammation. Nevertheless, there is a lack of information on the combination of both on alleviating inflammation, oxidative stress, and improving the quality of life (QoL). We investigated the synergistic effects of drinking AEW and walking on advanced glycation end products (AGEs), advanced oxidation protein products (AOPPs), malondialdehyde (MDA), white blood cells (WBCs), neutrophil-lymphocyte ratio (NLR) and QoL. In total, 81 eligible patients with type 2 diabetes (T2DM) were randomly allocated via single blind to four groups: consumed 2 L/day of AEW ( n = 20), instructed to walk for 150 min/week ( n = 20), received a combination of AEW and walking ( n = 20), and continue their habitual diet and activity ( n = 21). Data were collected and analyzed before and after 8 weeks of intervention. Our results showed a significant interaction between the group and time, with both AEW and walking independently and synergistically ameliorating AGEs, AOPPs, MDA, NLR and WBCs levels. Moreover, the AEW group had a higher physical and total QoL score. The walking group and the combined group had higher scores in physical, mental and total QoL compared to the control group. The synergistic effect of AEW and regular walking are an advisable treatment for patients with T2DM.",2020,"The walking group and the combined group had higher scores in physical, mental and total QoL compared to the control group.","['81 eligible patients with type 2 diabetes (T2DM', 'Individuals with Type 2 Diabetes', 'patients with T2DM']","['AEW and regular walking', 'combination of AEW and walking ( n = 20), and continue their habitual diet and activity', 'Alkaline electrolyzed water (AEW', 'Regular Walking and Alkaline Electrolyzed Water']","['higher scores in physical, mental and total QoL', 'AEW and walking independently and synergistically ameliorating AGEs, AOPPs, MDA, NLR and WBCs levels', 'Inflammation and Oxidative Stress, and Increasing Quality of Life', 'advanced glycation end products (AGEs), advanced oxidation protein products (AOPPs), malondialdehyde (MDA), white blood cells (WBCs), neutrophil-lymphocyte ratio (NLR) and QoL', 'quality of life (QoL', 'higher physical and total QoL score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C1976991', 'cui_str': 'Advanced oxidation protein products'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",81.0,0.0258548,"The walking group and the combined group had higher scores in physical, mental and total QoL compared to the control group.","[{'ForeName': 'Yohanes Andy', 'Initials': 'YA', 'LastName': 'Rias', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei 11031, Taiwan.'}, {'ForeName': 'Adi Lukas', 'Initials': 'AL', 'LastName': 'Kurniawan', 'Affiliation': 'Research Center for Healthcare Industry Innovation, National Taipei University of Nursing and Health Sciences, 365 Ming-te Road, Beitou District, Taipei 112, Taiwan.'}, {'ForeName': 'Ching Wen', 'Initials': 'CW', 'LastName': 'Chang', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Medical University Hospital, Taipei 11031, Taiwan.'}, {'ForeName': 'Christopher James', 'Initials': 'CJ', 'LastName': 'Gordon', 'Affiliation': 'Susan Wakil School of Nursing and Midwifery, Faculty of Medicine and Health, The University of Sydney, Camperdown 2050, Australia.'}, {'ForeName': 'Hsiu Ting', 'Initials': 'HT', 'LastName': 'Tsai', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei 11031, Taiwan.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9100946']
3078,33020113,Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial.,"INTRODUCTION
Airway clearance techniques (ACTs) are a gold standard of cystic fibrosis management; however, the majority of research evidence for their efficacy is of low standard; often attributed to the lack of sensitivity from outcome measures (OMs) used historically. This randomised controlled trial (RCT) investigates these standard OMs (sputum weight, forced expiratory volume in 1 s) and new OMs (electrical impedance tomography (EIT), multiple breath washout (MBW) and impulse oscillometry (IOS)) to determine the most useful measures of ACT.
METHODS AND ANALYSIS
This is a single-centre RCT with crossover design. Participants perform MBW, IOS and spirometry, and then are randomised to either rest or supervised ACT lasting 30-60 min. MBW, IOS and spirometry are repeated immediately afterwards. EIT and sputum are collected during rest/ACT. On a separate day, the OMs are performed with the other intervention. Primary endpoint is difference in change in OMs before and after ACT/rest. Sample size was calculated with 80% power and significance of 5% for each OM (target n=64).
ETHICS AND DISSEMINATION
Ethics approval was gained from the London-Chelsea Research Ethics Committee (reference 16/LO/0995, project ID 154635). Dissemination will involve scientific conference presentation and publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBERS
ISRCTN11220163 and NCT02721498.",2020,"This randomised controlled trial (RCT) investigates these standard OMs (sputum weight, forced expiratory volume in 1 s) and new OMs (electrical impedance tomography (EIT), multiple breath washout (MBW) and impulse oscillometry (IOS)) to determine the most useful measures of ACT.
",['adults with cystic fibrosis'],[],"['standard OMs (sputum weight, forced expiratory volume in 1 s) and new OMs (electrical impedance tomography (EIT), multiple breath washout (MBW) and impulse oscillometry (IOS', 'MBW, IOS and spirometry', 'Sample size', 'change in OMs before and after ACT/rest']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}]",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0029375', 'cui_str': 'Oscillometry'}, {'cui': 'C0242753', 'cui_str': 'Io'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",,0.168903,"This randomised controlled trial (RCT) investigates these standard OMs (sputum weight, forced expiratory volume in 1 s) and new OMs (electrical impedance tomography (EIT), multiple breath washout (MBW) and impulse oscillometry (IOS)) to determine the most useful measures of ACT.
","[{'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Stanford', 'Affiliation': 'Adult Cystic Fibrosis, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Davies', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Usmani', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Banya', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Charman', 'Affiliation': 'Cystic Fibrosis Trust, London, UK.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Department of Health Sciences, College of Health, Medicine and Life Scientists, Brunel University London, London, UK.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Simmonds', 'Affiliation': 'Adult Cystic Fibrosis, Royal Brompton Hospital, London, UK n.simmonds@imperial.ac.uk.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Bilton', 'Affiliation': 'Respiratory Medicine, Royal Brompton Hospital, London, UK.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000694']
3079,33026630,The Impact of OnabotulinumtoxinA vs. Placebo on Efficacy Outcomes in Headache Day Responder and Nonresponder Patients with Chronic Migraine.,"INTRODUCTION
The phase 3 PREEMPT trials demonstrated efficacy and tolerability of onabotulinumtoxinA for headache prevention in adults with chronic migraine. OnabotulinumtoxinA significantly reduced headache frequency from baseline vs. placebo at 24 weeks; however, this measure may not fully capture the benefits of treatment. We evaluated the impact of onabotulinumtoxinA on patient-reported outcomes according to headache responder status.
METHODS
A post hoc analysis pooled 24-week data from the placebo-controlled, randomized, double-blind treatment phases of the PREEMPT trials. Patients were stratified by randomized treatment (onabotulinumtoxinA vs. placebo) and headache day responder status (responder vs. nonresponder). Headache day responders had a ≥ 50% headache day reduction from baseline measured at weeks 21-24. Outcomes evaluated were patient-reported reductions in moderate-to-severe headache days, Headache Impact Test, and Migraine-Specific Quality of Life Questionnaire. Missing values were estimated using a modified last-observation-carried-forward approach.
RESULTS
In the pooled analysis population (N = 1384; onabotulinumtoxinA, n = 688; placebo, n = 696), headache day responder rates were 308/688 (45%) for onabotulinumtoxinA- and 238/696 (34%) for placebo-treated patients. At 24 weeks compared with baseline, onabotulinumtoxinA nonresponders showed significantly (all P < 0.01) greater mean (standard error) reductions vs. placebo nonresponders in moderate-to-severe headache days (- 3.5 [0.2] vs. - 2.4 [0.2]) and Headache Impact Test scores (- 2.3 [0.3] vs. - 0.8 [0.2]), and greater mean improvements in Migraine-Specific Quality of Life Questionnaire domains (Restrictive, 8.8 [1.0] vs. 2.9 [0.8]; Preventive, 6.0 [1.0] vs. 1.8 [0.8]; Emotional, 8.5 [1.3] vs. 2.8 [1.1]). Moderate-to-severe headache day and headache impact differences between nonresponder groups were evident at week 4 and sustained through week 24.
CONCLUSIONS
Relative to placebo nonresponders, onabotulinumtoxinA nonresponders experienced significant reductions in moderate-to-severe headache days and disability and improvement in quality of life, implying that the full benefits of onabotulinumtoxinA are not captured by headache day reduction.
TRIAL REGISTRATION
ClinicalTrials.gov identifiers, NCT00156910 (PREEMPT 1) and NCT00168428 (PREEMPT 2).",2020,"Moderate-to-severe headache day and headache impact differences between nonresponder groups were evident at week 4 and sustained through week 24.
","['Headache Day Responder and Nonresponder Patients with Chronic Migraine', 'adults with chronic migraine']","['randomized treatment (onabotulinumtoxinA vs. placebo', 'onabotulinumtoxinA', 'placebo', 'OnabotulinumtoxinA vs. Placebo', 'OnabotulinumtoxinA']","['Moderate-to-severe headache day and headache impact differences', 'Headache Impact Test scores', 'Migraine-Specific Quality of Life Questionnaire domains', 'headache day responder rates', 'moderate-to-severe headache days and disability', 'headache frequency', 'moderate-to-severe headache days, Headache Impact Test, and Migraine-Specific Quality of Life Questionnaire', 'quality of life', 'efficacy and tolerability']","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.433509,"Moderate-to-severe headache day and headache impact differences between nonresponder groups were evident at week 4 and sustained through week 24.
","[{'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA. stephen.silberstein@jefferson.edu.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Manack Adams', 'Affiliation': 'Allergan, an AbbVie Company, Irvine, CA, USA.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'DeGryse', 'Affiliation': 'AbbVie, Irvine, CA, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}]",Pain and therapy,['10.1007/s40122-020-00199-9']
3080,33026631,Benefits Beyond Headache Days With OnabotulinumtoxinA Treatment: A Pooled PREEMPT Analysis.,"INTRODUCTION
The double-blind, phase 3 PREEMPT trials demonstrated the efficacy and tolerability of onabotulinumtoxinA for headache prevention in adults with chronic migraine. This post hoc analysis evaluated the effect of onabotulinumtoxinA on clinically meaningful changes in headache severity, headache-related impact, and quality of life.
METHODS
Pooled, 24-week data were used to determine percentages of patients meeting responder criteria for the change in headache days (≥ 50% reduction in headache-day frequency), Headache Impact Test (HIT-6; ≥ 5-point improvement), MSQ Role Function-Restrictive (MSQ-RFR; ≥ 10.9-point improvement), and Average Daily Headache Severity (ADHS; ≥ 1-point improvement on a 4-point ordinal scale [0 = no pain, 3 = severe pain]).
RESULTS
In the pooled analysis population (N = 1384; onabotulinumtoxinA, n = 688; placebo, n = 696), significantly more patients treated with onabotulinumtoxinA compared with placebo were responders on HIT-6 (40.8 vs. 25.3%), MSQ-RFR (59.0 vs. 40.2%), and ADHS (35.5 vs. 22.4%) measures, and achieved traditional ≥ 50% reduction in headache days (44.8 vs. 34.2%; all P < 0.001). At least one responder criterion was met by 72.1% and 56.6% of onabotulinumtoxinA- and placebo-treated patients, respectively; all four were met by 20.4% and 8.6%, respectively (P < 0.001). Linear regression analysis showed that approximately 20% of the variance in HIT-6 and MSQ-RFR improvement was explained by improvement in headache days.
CONCLUSIONS
Treatment with onabotulinumtoxinA for 24 weeks was associated with clinically meaningful benefits beyond reduction in headache days; including reductions in headache severity and headache-related impact, and improved quality of life. While 45% of patients met responder criteria for monthly headache days, over 70% had clinically meaningful improvements on at least one outcome measure.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT00156910 (PREEMPT 1) and NCT00168428 (PREEMPT 2).",2020,"CONCLUSIONS
Treatment with onabotulinumtoxinA for 24 weeks was associated with clinically meaningful benefits beyond reduction in headache days; including reductions in headache severity and headache-related impact, and improved quality of life.",['adults with chronic migraine'],"['onabotulinumtoxinA- and placebo', 'placebo', 'onabotulinumtoxinA']","['headache severity and headache-related impact, and improved quality of life', 'headache days', 'headache-day frequency), Headache Impact Test (HIT-6;\u2009≥\u20095-point improvement), MSQ Role Function-Restrictive (MSQ-RFR', 'ADHS', 'HIT-6 and MSQ-RFR improvement', '4-point ordinal scale [0\u2009=\u2009no pain, 3\u2009=\u2009severe pain', 'Average Daily Headache Severity (ADHS;\u2009≥', 'MSQ-RFR', 'efficacy and tolerability', 'headache severity, headache-related impact, and quality of life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}]","[{'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3661947', 'cui_str': 'Daily headache'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.254152,"CONCLUSIONS
Treatment with onabotulinumtoxinA for 24 weeks was associated with clinically meaningful benefits beyond reduction in headache days; including reductions in headache severity and headache-related impact, and improved quality of life.","[{'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, University of Duisburg-Essen, Essen, Germany. h.diener@uni-essen.de.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Manack Adams', 'Affiliation': 'Allergan, an AbbVie Company, Irvine, CA, USA.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'DeGryse', 'Affiliation': 'AbbVie, Irvine, CA, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}]",Pain and therapy,['10.1007/s40122-020-00198-w']
3081,33022483,The Norwegian healthy body image intervention promotes positive embodiment through improved self-esteem.,"We examined both direct and indirect effects of the Healthy Body Image (HBI) intervention on positive embodiment among Norwegian high school students. In total, 2446 12th grade boys (43 %) and girls (mean age 16.8 years) from 30 schools participated in a cluster-randomized controlled study with the HBI intervention and a control condition as the study arms. We tested mediation models using path analysis and found that among several hypothesized mediators, only self-esteem mediated a positive intervention effect on positive embodiment for both boys and girls. A direct effect of the intervention on positive embodiment was only found in girls. The study provides novel findings indicating that health promotion interventions to address a positive embodiment should focus on enhancing adolescent's self-esteem. Serial mediation modeling might reveal more complex explanations of change mechanisms and could further evolve current knowledge.",2020,We examined both direct and indirect effects of the Healthy Body Image (HBI) intervention on positive embodiment among Norwegian high school students.,"['girls', 'Norwegian high school students', '2446 12th grade boys (43 %) and girls (mean age 16.8 years) from 30 schools participated in a cluster-randomized controlled study with the']","['HBI intervention', 'Healthy Body Image (HBI) intervention']",['positive embodiment'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517591', 'cui_str': '16.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0192935,We examined both direct and indirect effects of the Healthy Body Image (HBI) intervention on positive embodiment among Norwegian high school students.,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Sundgot-Borgen', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: chrsun@ous-hf.no.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stenling', 'Affiliation': 'Umeå University, Department of Psychology, 901 87 Umeå, Sweden. Electronic address: andreas.stenling@umu.se.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Rosenvinge', 'Affiliation': 'UiT -The Arctic University of Norway, Faculty of Health Sciences Department of Psychology, 9037 Tromsø, Norway. Electronic address: jan.rosenvinge@uit.no.'}, {'ForeName': 'Gunn', 'Initials': 'G', 'LastName': 'Pettersen', 'Affiliation': 'UiT -The Arctic University of Norway, Faculty of Health Sciences Department of Health and Caring Sciences, N- 9037 Tromsø, Norway. Electronic address: gunn.pettersen@uit.no.'}, {'ForeName': 'Oddgeir', 'Initials': 'O', 'LastName': 'Friborg', 'Affiliation': 'UiT -The Arctic University of Norway, Faculty of Health Sciences Department of Psychology, 9037 Tromsø, Norway. Electronic address: oddgeir.friborg@uit.no.'}, {'ForeName': 'Jorunn', 'Initials': 'J', 'LastName': 'Sundgot-Borgen', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: jorunn.sundgot-borgen@nih.no.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Kolle', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: elin.kolle@nih.no.'}, {'ForeName': 'Monica Klungland', 'Initials': 'MK', 'LastName': 'Torstveit', 'Affiliation': 'University of Agder, Faculty of Health and Sport Sciences, Postbox 422, 4604 Kristiansand, Norway. Electronic address: monica.k.torstveit@uia.no.'}, {'ForeName': 'Kethe M E', 'Initials': 'KME', 'LastName': 'Svantorp-Tveiten', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: k.m.e.engen@nih.no.'}, {'ForeName': 'Solfrid', 'Initials': 'S', 'LastName': 'Bratland-Sanda', 'Affiliation': 'University College of Southeast Norway, Department of Sports, Physical Education and Outdoor Studies, P.O. Box 235, N-3603 Kongsberg, Norway. Electronic address: Solfrid.Bratland-Sanda@usn.no.'}]",Body image,['10.1016/j.bodyim.2020.08.014']
3082,33023067,Effect of Maternal Docosahexaenoic Acid (DHA) Supplementation on Offspring Neurodevelopment at 12 Months in India: A Randomized Controlled Trial.,"Intake of dietary docosahexaenoic acid (DHA 22:6n-3) is very low among Indian pregnant women. Maternal supplementation during pregnancy and lactation may benefit offspring neurodevelopment. We conducted a double-blind, randomized, placebo-controlled trial to test the effectiveness of supplementing pregnant Indian women (singleton gestation) from ≤20 weeks through 6 months postpartum with 400 mg/d algal DHA compared to placebo on neurodevelopment of their offspring at 12 months. Of 3379 women screened, 1131 were found eligible; 957 were randomized. The primary outcome was infant neurodevelopment at 12 months, assessed using the Development Assessment Scale for Indian Infants (DASII). Both groups were well balanced on sociodemographic variables at baseline. More than 72% of women took >90% of their assigned treatment. Twenty-five serious adverse events (SAEs), none related to the intervention, (DHA group = 16; placebo = 9) were noted. Of 902 live births, 878 were followed up to 12 months; the DASII was administered to 863 infants. At 12 months, the mean development quotient (DQ) scores in the DHA and placebo groups were not statistically significant (96.6 ± 12.2 vs. 97.1 ± 13.0, p = 0.60). Supplementing mothers through pregnancy and lactation with 400 mg/d DHA did not impact offspring neurodevelopment at 12 months of age in this setting.",2020,"At 12 months, the mean development quotient (DQ) scores in the DHA and placebo groups were not statistically significant (96.6 ± 12.2 vs. 97.1 ± 13.0, p = 0.60).","['Indian pregnant women', 'supplementing pregnant Indian women (singleton gestation) from ≤20 weeks through 6 months postpartum with 400 mg', 'Offspring Neurodevelopment at 12 Months in India', '3379 women screened, 1131 were found eligible; 957 were randomized']","['Maternal Docosahexaenoic Acid (DHA) Supplementation', 'd algal DHA', 'placebo', 'Maternal supplementation', 'dietary docosahexaenoic acid (DHA 22:6n-3']","['mean development quotient (DQ) scores', 'infant neurodevelopment at 12 months, assessed using the Development Assessment Scale for Indian Infants (DASII']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0556102', 'cui_str': 'Docosahexaenoic acid supplementation'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}]",9.0,0.541987,"At 12 months, the mean development quotient (DQ) scores in the DHA and placebo groups were not statistically significant (96.6 ± 12.2 vs. 97.1 ± 13.0, p = 0.60).","[{'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Khandelwal', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Dimple', 'Initials': 'D', 'LastName': 'Kondal', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Chaudhry', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Patil', 'Affiliation': ""KAHER's JN Medical College, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Mallaiah Kenchaveeraiah', 'Initials': 'MK', 'LastName': 'Swamy', 'Affiliation': ""KAHER's JN Medical College, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Metgud', 'Affiliation': ""KAHER's Institute of Physiotherapy, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Sandesh', 'Initials': 'S', 'LastName': 'Jogalekar', 'Affiliation': ""KAHER's JN Medical College, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Kamate', 'Affiliation': ""KAHER's JN Medical College, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Divan', 'Affiliation': 'Sangath, C-1/52, Block C 1, Bhim Nagri, Hauz Khas, New Delhi 110016, India.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'All India Institute of Medical Sciences, Sri Aurobindo Marg, New Delhi 110029, India.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Ramakrishnan', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}]",Nutrients,['10.3390/nu12103041']
3083,33023132,Dietary Quality Changes According to the Preceding Maximum Weight: A Longitudinal Analysis in the PREDIMED-Plus Randomized Trial.,"One-year dietary quality change according to the preceding maximum weight in a lifestyle intervention program (PREDIMED-Plus trial, 55-75-year-old overweight or obese adults; n = 5695) was assessed. A validated food frequency questionnaire was used to assess dietary intake. A total of 3 groups were made according to the difference between baseline measured weight and lifetime maximum reported weight: (a) participants entering the study at their maximum weight, (b) moderate weight loss maintainers (WLM), and (c) large WLM. Data were analyzed by General Linear Model. All participants improved average lifestyle. Participants entering the study at their maximum weight were the most susceptible to improve significantly their dietary quality, assessed by adherence to Mediterranean diet, DII and both healthful and unhealthful provegetarian patterns. People at maximum weight are the most benefitted in the short term by a weight management program. Long term weight loss efforts may also reduce the effect of a weight management program.",2020,"Participants entering the study at their maximum weight were the most susceptible to improve significantly their dietary quality, assessed by adherence to Mediterranean diet, DII and both healthful and unhealthful provegetarian patterns.","['55-75-year-old overweight or obese adults; n = 5695', 'a) participants entering the study at their maximum weight, (b) moderate weight loss maintainers (WLM), and (c) large WLM']",[],"['weight and lifetime maximum reported weight', 'dietary quality, assessed by adherence to Mediterranean diet, DII and both healthful and unhealthful provegetarian patterns', 'average lifestyle', 'Dietary Quality Changes']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0385506', 'cui_str': 'didodecylindocarbocyanine'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0275905,"Participants entering the study at their maximum weight were the most susceptible to improve significantly their dietary quality, assessed by adherence to Mediterranean diet, DII and both healthful and unhealthful provegetarian patterns.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Bouzas', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Maria Del Mar', 'Initials': 'MDM', 'LastName': 'Bibiloni', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Garcia', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mateos', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Martínez-González', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schröder', 'Affiliation': ""Unit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d'Investigació Mèdica (IMIM), 08003 Barcelona, Spain.""}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Ángel M', 'Initials': 'ÁM', 'LastName': 'Alonso-Gómez', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wärnberg', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vioque', 'Affiliation': 'CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Romaguera', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lopez-Miranda', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Tinahones', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Bueno-Cavanillas', 'Affiliation': 'Instituto de Investigación Sanitaria y Biomédica de Alicante, ISABIAL-UMH, Miguel Hernández University, 46020 Alicante, Spain.'}, {'ForeName': 'Rafael M', 'Initials': 'RM', 'LastName': 'Micó-Pérez', 'Affiliation': 'Fundación Semergen, 28009 Madrid, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Delgado-Rodríguez', 'Affiliation': 'Department of Preventive Medicine and Public Health, IDISNA, University of Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Ortíz-Ramos', 'Affiliation': 'Department of Endocrinology and Nutrition, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Andreu', 'Initials': 'A', 'LastName': 'Altés-Boronat', 'Affiliation': 'Department of Endocrinology, IDIBAPS, Hospital Clinic, University of Barcelona, 08036 Barcelona, Spain.'}, {'ForeName': 'Bogdana L', 'Initials': 'BL', 'LastName': 'Luca', 'Affiliation': 'Department of Endocrinology, Fundación Jiménez-Díaz, 28040 Madrid, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Daimiel', 'Affiliation': 'Nutritional Control of the Epigenome Group, Precision Nutrition and Obesity Program, IMDEA Food, CEI UAM + CSIC, 28049 Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Sayon-Orea', 'Affiliation': 'Department of Preventive Medicine and Public Health, IDISNA, University of Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Becerra-Tomás', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Ignacio Manuel', 'Initials': 'IM', 'LastName': 'Gimenez-Alba', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Abete', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Tojal-Sierra', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Jéssica', 'Initials': 'J', 'LastName': 'Pérez-López', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bernabé-Casanova', 'Affiliation': 'Centro Salud Raval, 03203 Elche-Alicante, Spain.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Martin-Padillo', 'Affiliation': 'Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Garcia-Rios', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Castro-Barquero', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Fernández-García', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Santos-Lozano', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Cesar I', 'Initials': 'CI', 'LastName': 'Fernandez-Lazaro', 'Affiliation': 'Department of Preventive Medicine and Public Health, IDISNA, University of Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Hernández-Alonso', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Saiz', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Maria Dolors', 'Initials': 'MD', 'LastName': 'Zomeño', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Maria Angeles', 'Initials': 'MA', 'LastName': 'Zulet', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Belló-Mora', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'Basterra-Gortari', 'Affiliation': 'Department of Preventive Medicine and Public Health, IDISNA, University of Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Canudas', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Goday', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Josep A', 'Initials': 'JA', 'LastName': 'Tur', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}]",Nutrients,['10.3390/nu12103023']
3084,33023221,"Effect of Increasing the Dietary Protein Content of Breakfast on Subjective Appetite, Short-Term Food Intake and Diet-Induced Thermogenesis in Children.","Dietary protein affects energy balance by decreasing food intake (FI) and increasing energy expenditure through diet-induced thermogenesis (DIT) in adults. Our objective was to investigate the effects of increasing the dietary protein in an isocaloric breakfast on subjective appetite, FI, blood glucose, and DIT in 9-14 y children. Two randomized repeated measures designs were used. In experiment 1, 17 children (9 boys, 8 girls) consumed isocaloric meals (450 kcal) on four separate mornings containing: 7 g (control), 15 g (low protein, LP), 30 g (medium protein, MP) or 45 g (high protein, HP) of protein. Blood glucose and subjective appetite were measured at baseline and regular intervals for 4 h, and FI was measured at 4 h. In experiment 2, 9 children (6 boys, 3 girls) consumed the control or HP breakfast on two separate mornings, and both DIT and subjective appetite were determined over 5 h. In experiment 1, all dietary protein treatments suppressed subjective appetite compared to control ( p < 0.001), and the HP breakfast suppressed FI compared with the LP breakfast and control ( p < 0.05). In experiment 2, DIT was higher after HP than control ( p < 0.05). In conclusion, increasing the dietary protein content of breakfast had favorable effects on satiety, FI, and DIT in children.",2020,"In experiment 1, all dietary protein treatments suppressed subjective appetite compared to control ( p < 0.001), and the HP breakfast suppressed FI compared with the LP breakfast and control ( p < 0.05).","['adults', '9 children (6 boys, 3 girls', '9-14', '17 children (9 boys, 8 girls', 'Children', 'y children']","['control or HP breakfast', 'Dietary Protein Content of Breakfast', 'consumed isocaloric meals']","['satiety, FI, and DIT', 'HP breakfast suppressed FI', 'subjective appetite, FI, blood glucose, and DIT', 'Blood glucose and subjective appetite', 'subjective appetite', 'DIT and subjective appetite']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]",,0.0125685,"In experiment 1, all dietary protein treatments suppressed subjective appetite compared to control ( p < 0.001), and the HP breakfast suppressed FI compared with the LP breakfast and control ( p < 0.05).","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bellissimo', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Fansabedian', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Vincent C H', 'Initials': 'VCH', 'LastName': 'Wong', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Julia O', 'Initials': 'JO', 'LastName': 'Totosy de Zepetnek', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, SK S4S-0A2, Canada.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Brett', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Schwartz', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Cassin', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Suitor', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Dérick', 'Initials': 'D', 'LastName': 'Rousseau', 'Affiliation': 'Department of Chemistry & Biology, Ryerson University, Toronto, ON M5B-2K3, Canada.'}]",Nutrients,['10.3390/nu12103025']
3085,33029896,Clinical comparison of an electric-powered ionic toothbrush and a manual toothbrush in plaque reduction: A randomized clinical trial.,"OBJECTIVES
This study aimed to evaluate the plaque removal efficacy of a newly developed electric-powered ionic toothbrush vs. a manual toothbrush.
MATERIALS AND METHODS
Manual or electric-powered ionic toothbrushes were randomly assigned to 30 healthy volunteers divided into two groups (Phase I). After 2 min of brushing, all tooth surfaces were stained with a plaque staining solution, and blinded examiners performed scoring using the Rustogi Modification of the Navy Plaque Index. Plaque removal rate was calculated at the central incisors, first premolar and first molar, as representative teeth, in the maxilla and mandibula. One week following Phase I, the same examinations were repeated in all subjects using another toothbrush (Phase II), as a crossover design.
RESULTS
Electric ionic toothbrushes demonstrated a significantly higher plaque removal rate than manual toothbrushes in the premolar and molar areas (p < .05). However, in the central incisor area, no statistically significant difference was observed.
CONCLUSIONS
Compared with manual toothbrushes, electric-powered ionic ones were significantly efficient in removing plaque in the premolar and molar areas.",2020,"Compared to manual toothbrushes, electric-powered ionic ones were significantly efficient in removing plaque in the premolar and molar areas.",['Manual or electric-powered ionic toothbrushes were randomly assigned to 30 healthy volunteers divided into two groups (Phase I'],"['electric-powered ionic toothbrush', 'newly-developed electric-powered ionic toothbrush vs. a manual toothbrush']","['plaque removal efficacy', 'plaque removal rate', 'Plaque removal rate']","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0490733', 'cui_str': 'Manual toothbrush'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",30.0,0.0143584,"Compared to manual toothbrushes, electric-powered ionic ones were significantly efficient in removing plaque in the premolar and molar areas.","[{'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Ikawa', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Mizutani', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Takeaki', 'Initials': 'T', 'LastName': 'Sudo', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Kano', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Akizuki', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Izumi', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Iwata', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}]",International journal of dental hygiene,['10.1111/idh.12475']
3086,33016931,Working Memory Training for Older Participants: A Control Group Training Regimen and Initial Intellectual Functioning Assessment.,"The efficacy of cognitive training interventions is recently highly debated. There is no consensus on what kind of training regimen is the most effective. Also, individual characteristics as predictors of training outcome are still being investigated. In this article, we show the attempt to address this issue by examining not only the impact of working memory (WM) training on cognitive effectiveness in older adults but also the influence of the initial WM capacity (WMC) on the training's outcome. We describe in detail how to perform 5 weeks of an adaptive dual n-back training with an active control group (memory quiz). We are focusing here on technical aspects of the training as well as on the initial assessment of participants' WMC. The evaluation of pre and post training performance of other cognitive dimensions was based on the results of tests of memory updating, inhibition, attention shifting, short-term memory (STM) and reasoning. We have found that the initial level of WMC predicts the efficiency of the n-back training intervention. We have also noticed the post training improvement in almost all aspects of cognitive functioning we measured, but those effects were mostly intervention independent.",2020,"We have also noticed the post training improvement in almost all aspects of cognitive functioning we measured, but those effects were mostly intervention independent.","['older adults', 'Older Participants']","['adaptive dual n-back training with an active control group (memory quiz', 'cognitive training interventions', 'Working Memory Training', 'working memory (WM) training']","['cognitive effectiveness', 'memory updating, inhibition, attention shifting, short-term memory (STM) and reasoning']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}]",,0.0159781,"We have also noticed the post training improvement in almost all aspects of cognitive functioning we measured, but those effects were mostly intervention independent.","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Matysiak', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Zarzycka', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Bramorska', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities.'}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Brzezicka', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities; Department of Neurosurgery, Cedars-Sinai Medical Center; abrzezi2@swps.edu.pl.'}]",Journal of visualized experiments : JoVE,['10.3791/60804']
3087,33011546,"Could ""triple-therapy"" considered as a novel-optimal treatment model for acute bipolar depression? A prospective real-world research in China.","BACKGROUND
Results of researches of bipolar depression treatment are inconsistent and to our knowledge, no study has previously revealed an optimal treatment model for bipolar depression in the real-world through a prospective way.
OBJECTIVE
To find out an optimal treatment model for bipolar depression in the real-world by evaluating the effect of different treatment models: monotherapy, double-therapy and triple-therapy.
DESIGN
and Intervention: This 12 or 16-week, multi-center, real-world clinical study was conducted at 15 study sites (inpatient or outpatient department) in West China and a total of 573 patients completed the follow-up. During the study weeks, all researchers could choose a most proper treatment model freely basing on the evaluation of patient's symptoms and complete the follow-up according to the procedure.
MAIN OUTCOMES AND MEASURES
The primary outcomes were baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) total score and the constituent ratio of effects. Total score change in Young Mania Rating Scale (YMRS) and Clinical Global Impression (CGI) from baseline to endpoint, treatment-emergent mania rate and severe adverse events rate were used as secondary outcomes.
RESULTS
During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001). At week 4, mean scores of MARDS in triple-therapy group are statistically significant lower than monotherapy group (P = 0.013) and at the endpoint, mean scores of MARDS in triple-therapy group are statistically significant lower than both double-therapy and monotherapy groups (P = 0.011). The severe adverse events rates are rare in all the 3 groups at week 4 and endpoint, and the rate of dry mouth in triple-therapy group at week 4 is statistically significant lower than the other 2 groups (P = 0.002).
CONCLUSIONS
Triple-therapy is more effective in treating bipolar depression than double-therapy and monotherapy model with a lower risk of developing manic symptoms.
TRIAL REGISTRATION
Chinese Clinical Trial Registry. Identifier: ChiCTR1800019064.",2020,"During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001).",['15 study sites (inpatient or outpatient department) in West China and a total of 573 patients completed the follow-up'],"['monotherapy, double-therapy and triple-therapy']","['severe adverse events rates', 'MARDS, YMRS and CGI', 'mean scores of MARDS', 'rate of dry mouth', 'baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) total score and the constituent ratio of effects', 'mania rate and severe adverse events rate', 'response and response rates', 'Total score change in Young Mania Rating Scale (YMRS) and Clinical Global Impression (CGI', 'mania rates']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205174', 'cui_str': 'Triple'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0338831', 'cui_str': 'Mania'}]",573.0,0.0263737,"During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001).","[{'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Sichuan Provincial Center for Mental Health, Psychosomatic Medical Center of Sichuan People's Hospital, China.""}, {'ForeName': 'Ruhan', 'Initials': 'R', 'LastName': 'A', 'Affiliation': 'Sleep Medicine Center of University of Electronic Science and Technology Hospital, China.'}, {'ForeName': 'Yuexin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China. Electronic address: sunxueli2018@126.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.09.017']
3088,33011649,The Unified Protocol compared with diagnosis-specific protocols for anxiety disorders: 12-month follow-up from a randomized clinical trial.,"OBJECTIVE
To examine whether the Unified Protocol (UP) remains equivalent to single-disorder protocols (SDPs) in the treatment of anxiety disorders at 12-month follow-up.
METHOD
We report results from the 12-month follow-up of a recent randomized equivalence trial [1]. Data are from 179 participants (55.31% female sex, 83.24% White, average age 30.66) who met criteria for a principal anxiety disorder and were randomized to either the UP or SDP conditions. Consistent with the parent trial, the primary outcome was principal diagnosis clinician severity rating (CSR) from the Anxiety Disorder Interview Schedule (ADIS). Secondary outcomes included anxiety, depression, and impairment. Missing data were accommodated using multiple imputation (10,000 imputed data sets) under a missing at random assumption. Equivalence between the UP and SDPs was tested using slope difference scores from latent growth models and 95% confidence interval of between-condition effect sizes.
RESULTS
The results indicated that the UP and SDP conditions remained equivalent with regard to principal diagnosis clinician severity rating at 12-month follow-up. In addition, there were no significant differences between conditions on secondary outcomes at 12-month follow-up.
CONCLUSIONS
The UP continues to yield outcomes comparable to SDPs at 12-month follow-up, and therefore provides a single intervention that can be used to treat the most commonly occurring psychiatric disorders with durable effects.",2020,The results indicated that the UP and SDP conditions remained equivalent with regard to principal diagnosis clinician severity rating at 12-month follow-up.,"['179 participants (55.31% female sex, 83.24% White, average age 30.66) who met criteria for a principal anxiety disorder']",['diagnosis-specific protocols'],"['anxiety, depression, and impairment', 'principal diagnosis clinician severity rating (CSR) from the Anxiety Disorder Interview Schedule (ADIS', 'principal diagnosis clinician severity rating']","[{'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]",,0.0824821,The results indicated that the UP and SDP conditions remained equivalent with regard to principal diagnosis clinician severity rating at 12-month follow-up.,"[{'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Eustis', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America. Electronic address: eeustis@bu.edu.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Gallagher', 'Affiliation': 'Department of Psychology, The University of Houston, Health and Biomedical Sciences Building, 4849 Calhoun Rd - Room 373, Houston, TX 77204, United States of America.'}, {'ForeName': 'Julianne W', 'Initials': 'JW', 'LastName': 'Tirpak', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Nauphal', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.08.012']
3089,33017662,Clinical Outcomes in Patients with FLT3-ITD-Mutated Relapsed/Refractory Acute Myelogenous Leukemia Undergoing Hematopoietic Stem Cell Transplantation after Quizartinib or Salvage Chemotherapy in the QuANTUM-R Trial.,"Despite the substantial clinical activity of fms-related tyrosine kinase 3 (FLT3) inhibitors in relapsed or refractory (R/R) FLT3-ITD‒positive acute myelogenous leukemia (AML), durable remissions and prolonged survival in this population require allogeneic hematopoietic stem cell transplantation (allo-HSCT). Quizartinib, a once-daily oral, highly potent, and selective FLT3 inhibitor, significantly prolonged overall survival (OS) and improved clinical benefit compared with salvage chemotherapy (median OS, 6.2 months versus 4.7 months; hazard ratio [HR], .76; 95% confidence interval [CI], .58 to .98; P = .018; composite complete remission [CRc] rate, 48% versus 27%; median duration of CRc, 2.8 months versus 1.2 months; mortality rate, .8% versus 14% by day 30, 7% versus 24% by day 60) in patients with R/R FLT3-ITD AML in the phase 3 QuANTUM-R trial. In this post hoc analysis, we described the characteristics of and clinical outcomes in patients who underwent on-study HSCT in QuANTUM-R at the investigator's discretion and institutional practices. Of 367 randomized patients, 78 (32%) in the quizartinib arm and 14 (11%) in the salvage chemotherapy arm underwent on-study allo-HSCT without any intervening therapy for AML after quizartinib or study-specified salvage chemotherapy. Pooled data of patients from both treatment arms showed a longer median overall survival (OS) in transplant recipients versus those treated without HSCT (12.2 months versus 4.4 months; HR, .315; 95% CI, .233 to .427). Pooled data also showed a longer median OS in patients with a last recorded response of CRc before allo-HSCT versus patients without a CRc (20.1 months versus 8.8 months; HR, .506; 95% CI, .296 to .864). By treatment arm, the median OS was 25.1 months with quizartinib and 20.1 months with salvage chemotherapy in patients with a last recorded response of CRc before allo-HSCT. Forty-eight patients in the quizartinib arm continued quizartinib treatment after allo-HSCT. In the 31 patients with a last recorded response of CRc before allo-HSCT who continued quizartinib after allo-HSCT, the median OS was 27.1 months. Continuation of quizartinib after allo-HSCT was tolerable, and no new safety signals were identified. These results suggest that post-transplantation survival following salvage chemotherapy and quizartinib treatment are similar. However, quizartinib response occurs more frequently than with salvage chemotherapy, potentially allowing more patients to undergo transplantation and achieve durable clinical benefit. In addition, post-HSCT quizartinib was found to be tolerable and may be associated with prolonged survival in some patients, highlighting its potential value in the management of patients with FLT3-ITD R/R AML.",2020,"Pooled data of patients from both treatment arms showed a longer median OS in transplanted patients vs those treated without a transplant (12.2 vs 4.4 months; HR, 0.315","['Patients With FLT3-ITD-Mutated Relapsed/Refractory Acute Myeloid Leukemia', 'Undergoing Hematopoietic Stem Cell Transplant', 'Forty-eight patients in the quizartinib arm continued quizartinib treatment after allo-HSCT', '367 randomized patients, 78 (32%) in the quizartinib arm and 14 (11%) in the salvage chemotherapy arm underwent an on-study allo', 'patients who underwent an on-study HSCT in QuANTUM-R per investigator discretion and institutional practices']","['HSCT without any intervening therapy for AML after quizartinib or study-specified salvage chemotherapy', 'Quizartinib or Salvage Chemotherapy', 'salvage chemotherapy']","['median duration of CRc', 'overall survival (OS', 'longer median OS', 'mortality rates', 'quizartinib response', 'response of CRc', 'median OS', 'prolonged survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1570097', 'cui_str': 'FER protein, human'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4528668', 'cui_str': 'Acute myeloid leukaemia refractory'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C2980091', 'cui_str': 'quizartinib'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0021626', 'cui_str': 'Institutional Practice'}]","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C2980091', 'cui_str': 'quizartinib'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C2980091', 'cui_str': 'quizartinib'}]",367.0,0.0468284,"Pooled data of patients from both treatment arms showed a longer median OS in transplanted patients vs those treated without a transplant (12.2 vs 4.4 months; HR, 0.315","[{'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Ganguly', 'Affiliation': 'Division of Hematological Malignancies and Cellular Therapeutics, The University of Kansas Health System, Kansas City, Kansas. Electronic address: sganguly@kumc.edu.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Georgia Cancer Center, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'Krämer', 'Affiliation': 'Heidelberg University and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Levis', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Martinelli', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}, {'ForeName': 'Alexander E', 'Initials': 'AE', 'LastName': 'Perl', 'Affiliation': 'Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Nigel H', 'Initials': 'NH', 'LastName': 'Russell', 'Affiliation': 'Nottingham University Hospital, Nottingham, United Kingdom.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Arunachalam', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, New Jersey.'}, {'ForeName': 'Cedric Dos', 'Initials': 'CD', 'LastName': 'Santos', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, New Jersey.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Gammon', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, New Jersey.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Lesegretain', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, New Jersey.'}, {'ForeName': 'Derek E', 'Initials': 'DE', 'LastName': 'Mires', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, New Jersey.'}, {'ForeName': 'Hoang', 'Initials': 'H', 'LastName': 'Pham', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, New Jersey.'}, {'ForeName': 'Yibin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, New Jersey.'}, {'ForeName': 'Samer K', 'Initials': 'SK', 'LastName': 'Khaled', 'Affiliation': 'City of Hope National Medical Center, Duarte, California.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.09.036']
3090,33017784,Nitrous oxide analgesia for external cephalic version: A randomized controlled trial.,"STUDY OBJECTIVE
Our study sought to determine whether or not nitrous oxide analgesia decreases pain compared to oxygen placebo during external cephalic version for breech presentation. Procedural success may be limited by pain and anxiety. Although neuraxial anesthesia has been studied extensively for these procedures, many centers lack resources for routine use. Nitrous oxide is noninvasive, has minimal side effects and requires limited facilities. We hypothesized that its analgesic properties would decrease pain compared to oxygen placebo during external cephalic version.
DESIGN
Double-blinded randomized placebo-controlled trial.
SETTING
Labor and delivery triage room.
PATIENTS
Forty-eight patients, ≥18 years of age, 37-weeks' gestation or beyond, singleton pregnancy, breech presentation, and American Society of Anesthesiology physical status I-III, having an external cephalic version.
INTERVENTIONS
Patients undergoing external cephalic version were randomized to receive self-administered 50% nitrous oxide/50% oxygen versus 100% oxygen placebo.
MEASUREMENTS
The primary outcome measured was intra-procedural pain. Secondary outcomes were intra-procedural anxiety, patient satisfaction, and procedure difficulty.
MAIN RESULTS
Forty-eight patients were enrolled; 23 received nitrous oxide and 25 received oxygen. No difference was noted in mean pain scores (nitrous oxide 5.5 ± 2.3, placebo 5.4 ± 2.7, [CI 95% = -1.40, 1.51]; P = 0.943) or anxiety scores (nitrous oxide 1.6 ± 2.0, placebo 1.2 ± 1.8, [CI 95% = -0.74, 1.45]; P = 0.515). Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95% = -1.54, 1.66]; P = 0.944). There was a significant increase in the number of version attempts in the nitrous oxide group (nitrous oxide 3.9 ± 1.9, placebo 2.8 ± 1.4, [CI 95% = 0.05, 2]; P = 0.046). Patient satisfaction was significantly lower in the nitrous oxide group (nitrous oxide 4.3 ± 4.0, placebo 6.9 ± 3.6, [CI 95% = -4.93, -0.34]; P = 0.025).
CONCLUSION
Despite the desirable properties of nitrous oxide, there was no analgesic benefit over oxygen for external cephalic version. Its routine use for these procedures was not supported.",2020,"Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95% = -1.54, 1.66];","['external cephalic version', 'Forty-eight patients were enrolled; 23 received', 'Patients undergoing external cephalic version', ""Forty-eight patients, ≥18\xa0years of age, 37-weeks' gestation or beyond, singleton pregnancy, breech presentation, and American Society of Anesthesiology physical status I-III, having an external cephalic version"", 'Labor and delivery triage room']","['placebo', 'Nitrous oxide', 'nitrous oxide and 25 received oxygen', 'oxygen placebo', 'Nitrous oxide analgesia', 'self-administered 50% nitrous oxide/50% oxygen versus 100% oxygen placebo', 'nitrous oxide analgesia', 'nitrous oxide']","['mean pain scores', 'Patient satisfaction', 'anxiety scores', 'Procedural difficulty', 'intra-procedural anxiety, patient satisfaction, and procedure difficulty', 'number of version attempts', 'intra-procedural pain', 'pain']","[{'cui': 'C0410877', 'cui_str': 'External cephalic version'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006157', 'cui_str': 'Breech presentation'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0040861', 'cui_str': 'Triage'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C3854439', 'cui_str': 'Procedural anxiety'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",48.0,0.62946,"Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95% = -1.54, 1.66];","[{'ForeName': 'Lacey E', 'Initials': 'LE', 'LastName': 'Straube', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Lacey_straube@med.unc.edu.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Fardelmann', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Kristen.fardelmann@yale.edu.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Penwarden', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: APenwarden@napaanesthesia.com.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: fei_chen@med.unc.edu.'}, {'ForeName': 'Elsje', 'Initials': 'E', 'LastName': 'Harker', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: elsje.harker@duke.unc.edu.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Redmon', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Benjamin.redmon@duke.edu.'}, {'ForeName': 'Quefeng', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'University of North Carolina School of Public Health, Department of Biostatistics, 135 Dauer Drive, Chapel Hill, NC 27599, USA. Electronic address: quefeng@email.unc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Strauss', 'Affiliation': 'University of North Carolina School of Medicine, Department of Obstetrics & Gynecology, 3009 Old Clinic Building, CB 7050, Chapel Hill, NC 27599, USA. Electronic address: Robert_strauss@med.unc.edu.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Smith', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Kathleen_a_smith@med.unc.edu.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110073']
3091,33026154,"The PREVIEW intervention study: Results from a 3-year randomized 2 x 2 factorial multinational trial investigating the role of protein, glycaemic index and physical activity for prevention of type 2 diabetes.","AIM
To compare the impact of two long-term weight-maintenance diets, a high protein (HP) and low glycaemic index (GI) diet versus a moderate protein (MP) and moderate GI diet, combined with either high intensity (HI) or moderate intensity physical activity (PA), on the incidence of type 2 diabetes (T2D) after rapid weight loss.
MATERIALS AND METHODS
A 3-year multicentre randomized trial in eight countries using a 2 x 2 diet-by-PA factorial design was conducted. Eight-week weight reduction was followed by a 3-year randomized weight-maintenance phase. In total, 2326 adults (age 25-70 years, body mass index ≥ 25 kg/m 2 ) with prediabetes were enrolled. The primary endpoint was 3-year incidence of T2D analysed by diet treatment. Secondary outcomes included glucose, insulin, HbA1c and body weight.
RESULTS
The total number of T2D cases was 62 and the cumulative incidence rate was 3.1%, with no significant differences between the two diets, PA or their combination. T2D incidence was similar across intervention centres, irrespective of attrition. Significantly fewer participants achieved normoglycaemia in the HP compared with the MP group (P < .0001). At 3 years, normoglycaemia was lowest in HP-HI (11.9%) compared with the other three groups (20.0%-21.0%, P < .05). There were no group differences in body weight change (-11% after 8-week weight reduction; -5% after 3-year weight maintenance) or in other secondary outcomes.
CONCLUSIONS
Three-year incidence of T2D was much lower than predicted and did not differ between diets, PA or their combination. Maintaining the target intakes of protein and GI over 3 years was difficult, but the overall protocol combining weight loss, healthy eating and PA was successful in markedly reducing the risk of T2D. This is an important clinically relevant outcome.",2020,Signficantly fewer achieved normo-glycemia in the HP compared with the MP group (p<0.0001).,"['2,326 adults (25-70 y, BMI≥25 kg/m 2 ) with pre-diabetes were enrolled']",[],"['glucose, insulin, HbA1C, and body weight', 'body weight change', 'T2D incidence', 'protein (HP), low-glycaemic index (GI) and moderate-protein (MP), moderate-GI, combined with high-intensity (HI) or moderate-intensity (MI) physical activity (PA) on incidence of type-2 diabetes (T2D', 'normo-glycemia', '3-year incidence of T2D']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",[],"[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0439234', 'cui_str': 'year'}]",2326.0,0.108454,Signficantly fewer achieved normo-glycemia in the HP compared with the MP group (p<0.0001).,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Raben', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Pia Siig', 'Initials': 'PS', 'LastName': 'Vestentoft', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Brand-Miller', 'Affiliation': 'School of Life and Environmental Sciences and Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Elli', 'Initials': 'E', 'LastName': 'Jalo', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Mathjis', 'Initials': 'M', 'LastName': 'Drummen', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM, School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Simpson', 'Affiliation': ""Division of Physiology, Pharmacology and Neuroscience, School of Life Sciences, Queen's Medical Centre, MRC/ARUK Centre for Musculoskeletal Ageing Research, ARUK Centre for Sport, Exercise and Osteoarthritis, National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham, UK.""}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martinez', 'Affiliation': 'Centre for Nutrition Research, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Handjieva-Darlenska', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Stratton', 'Affiliation': 'College of Engineering, Applied Sports, Technology, Exercise and Medicine (A-STEM) Research Centre, Swansea, UK.'}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Huttunen-Lenz', 'Affiliation': 'Exercise and Health Sciences, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Lam', 'Affiliation': 'NetUnion sarl, Lausanne, Switzerland.'}, {'ForeName': 'Jouko', 'Initials': 'J', 'LastName': 'Sundvall', 'Affiliation': 'Department of Government Services, Forensic Toxicology Unit, Biochemistry Laboratory, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Muirhead', 'Affiliation': 'School of Life and Environmental Sciences and Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Poppitt', 'Affiliation': 'Human Nutrition Unit, School of Biological Sciences, Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Kirsi H', 'Initials': 'KH', 'LastName': 'Pietiläinen', 'Affiliation': 'Obesity Research Unit, Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki and Obesity Centre, Endocrinology, Abdominal Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'Westerterp-Plantenga', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM, School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Moira A', 'Initials': 'MA', 'LastName': 'Taylor', 'Affiliation': ""Division of Physiology, Pharmacology and Neuroscience, School of Life Sciences, Queen's Medical Centre, National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham, UK.""}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Navas-Carretero', 'Affiliation': 'Centre for Nutrition Research, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Svetoslav', 'Initials': 'S', 'LastName': 'Handjiev', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Melitta A', 'Initials': 'MA', 'LastName': 'McNarry', 'Affiliation': 'College of Engineering, Applied Sports, Technology, Exercise and Medicine (A-STEM) Research Centre, Swansea, UK.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Hansen', 'Affiliation': 'Exercise and Health Sciences, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Råman', 'Affiliation': 'Department of Government Services, Forensic Toxicology Unit, Biochemistry Laboratory, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Brodie', 'Affiliation': 'School of Life and Environmental Sciences and Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Marta P', 'Initials': 'MP', 'LastName': 'Silvestre', 'Affiliation': 'Human Nutrition Unit, School of Biological Sciences, Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Tanja C', 'Initials': 'TC', 'LastName': 'Adam', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM, School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Macdonald', 'Affiliation': ""Division of Physiology, Pharmacology and Neuroscience, School of Life Sciences, Queen's Medical Centre, MRC/ARUK Centre for Musculoskeletal Ageing Research, ARUK Centre for Sport, Exercise and Osteoarthritis, National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham, UK.""}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'San-Cristobal', 'Affiliation': 'Centre for Nutrition Research, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Nadka', 'Initials': 'N', 'LastName': 'Boyadjieva', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Mackintosh', 'Affiliation': 'College of Engineering, Applied Sports, Technology, Exercise and Medicine (A-STEM) Research Centre, Swansea, UK.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schlicht', 'Affiliation': 'Exercise and Health Sciences, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Human Nutrition Unit, School of Biological Sciences, Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Fogelholm', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14219']
3092,33022957,Short-Term Effects of Salt Restriction via Home Dishes Do Not Persist in the Long Term: A Randomized Control Study.,"Salt intake reduction is crucial to prevent non-communicable diseases (NCDs) globally. This study aimed to investigate the short- and long-term effects of monitoring salt concentration in homemade dishes on reducing salt intake in a Japanese population. A double-blind randomized controlled trial using a 2 × 2 factorial design with two interventions was conducted in 195 participants; they were assigned to both interventions for a group monitoring salt concentration in soups (control: no monitoring) and a group using low-sodium seasoning (control: regular seasoning). We evaluated 24-hour urinary sodium excretions at baseline and after a three-month intervention for the changes as major outcomes, at six- and twelve-months after baseline as long-term follow-up surveys. Urinary sodium excretion decreased in both intervention and control groups after the intervention. However, differences in the change for both monitoring and low-sodium seasoning interventions were statistically non-significant ( p = 0.29 and 0.52, respectively). Urinary sodium excretion returned to the baseline level after twelve-months for all groups. Monitoring of salt concentration is ineffective in reducing salt intake for short- and long-term among the people studied in this cohort.",2020,Urinary sodium excretion decreased in both intervention and control groups after the intervention.,"['195 participants', 'a Japanese population']","['group monitoring salt concentration in soups (control: no monitoring) and a group using low-sodium seasoning (control: regular seasoning', 'Salt Restriction via Home Dishes']","['24-hour urinary sodium excretions', 'Urinary sodium excretion', 'salt intake']","[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0453399', 'cui_str': 'Soup'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0020498', 'cui_str': 'Disseminated idiopathic skeletal hyperostosis'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",195.0,0.0944828,Urinary sodium excretion decreased in both intervention and control groups after the intervention.,"[{'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Maruya', 'Affiliation': ""Department of Food Science and Nutrition, Faculty of Human Life and Environment, Nara Women's University, Kitauoya-Nishimachi, Nara 630-8506, Japan.""}, {'ForeName': 'Ribeka', 'Initials': 'R', 'LastName': 'Takachi', 'Affiliation': ""Department of Food Science and Nutrition, Faculty of Human Life and Environment, Nara Women's University, Kitauoya-Nishimachi, Nara 630-8506, Japan.""}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Kanda', 'Affiliation': ""Department of Food Science and Nutrition, Faculty of Human Life and Environment, Nara Women's University, Kitauoya-Nishimachi, Nara 630-8506, Japan.""}, {'ForeName': 'Misako', 'Initials': 'M', 'LastName': 'Nakadate', 'Affiliation': 'Department of Food and Life Science, Azabu University, 1-17-71 Fuchinobe, Chuo-ku, Sagamihara-city 252-5201, Kanagawa, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Ishihara', 'Affiliation': 'Department of Food and Life Science, Azabu University, 1-17-71 Fuchinobe, Chuo-ku, Sagamihara-city 252-5201, Kanagawa, Japan.'}]",Nutrients,['10.3390/nu12103034']
3093,33022968,Integrated Strength and Fundamental Movement Skill Training in Children: A Pilot Study.,"Competence in fundamental movement skills is essential to enable children to be physically active. We investigated the effect of an integrated fundamental movement skill with a strength training intervention on children's fundamental movement skills. Seventy-two (53% female) 10- to 11-year-old children from three primary schools assented to take part in this study (87% compliance). Schools were randomly allocated to a control (no intervention; n = 21), fundamental movement skill (FMS) (n = 18) or FMS and strength (FMS + ; n = 20) group. Interventions were delivered twice weekly for four weeks, in addition to normal physical education. FMS competence was measured through the Canadian agility and movement skills assessment (CAMSA) (product-process) and through countermovement jump (CMJ) and 40-m sprint tests (product). Improvements were observed in the CAMSA in both FMS (4.6, 95% confidence intervals 2.9 to 6.4 Arbitrary Units (AUs), second-generation p -value ( p δ ) = 0.03) and FMS + (3.9, 2.1 to 5.3 AU, p δ = 0.28) with no difference beyond our minimum threshold of 3 AU observed between these intervention groups ( p δ = 1). Clear improvements in CMJ were observed in FMS + relative to the control (25, 18 to 32%, p δ = 0) and FMS groups (15, 6.1 to 24%, p δ = 0). These preliminary data suggest combined FMS and strength training warrants further investigation as a tool to develop fundamental movement skills in children.",2020,"Improvements were observed in the CAMSA in both FMS (4.6, 95% confidence intervals 2.9 to 6.4 Arbitrary Units (AUs), second-generation p -value ( p δ ) = 0.03) and FMS + (3.9, 2.1 to 5.3 AU, p δ = 0.28) with no difference beyond our minimum threshold of 3 AU observed between these intervention groups ( p δ = 1).","['Seventy-two (53% female', ""children's fundamental movement skills"", '10- to 11-year-old children from three primary schools assented to take part in this study (87% compliance', 'children', 'Children']","['Integrated Strength and Fundamental Movement Skill Training', 'integrated fundamental movement skill with a strength training intervention', 'fundamental movement skill (FMS']","['Canadian agility and movement skills assessment (CAMSA) (product-process) and through countermovement jump (CMJ) and 40-m sprint tests (product', 'FMS competence', 'CMJ']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0220531,"Improvements were observed in the CAMSA in both FMS (4.6, 95% confidence intervals 2.9 to 6.4 Arbitrary Units (AUs), second-generation p -value ( p δ ) = 0.03) and FMS + (3.9, 2.1 to 5.3 AU, p δ = 0.28) with no difference beyond our minimum threshold of 3 AU observed between these intervention groups ( p δ = 1).","[{'ForeName': 'Fay', 'Initials': 'F', 'LastName': 'Grainger', 'Affiliation': 'Department of Science, School of Health and Life Sciences, Teesside University, Middlesbrough TS1 3BX, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Innerd', 'Affiliation': 'Department of Science, School of Health and Life Sciences, Teesside University, Middlesbrough TS1 3BX, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': 'Department of Science, School of Health and Life Sciences, Teesside University, Middlesbrough TS1 3BX, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Department of Science, School of Health and Life Sciences, Teesside University, Middlesbrough TS1 3BX, UK.'}]","Children (Basel, Switzerland)",['10.3390/children7100161']
3094,33022987,Ingestion of Helianthus tuberosus at Breakfast Rather Than at Dinner Is More Effective for Suppressing Glucose Levels and Improving the Intestinal Microbiota in Older Adults.,"To date, nutritional studies have focused on the total intake of dietary fiber rather than intake timing. In this study, we examined the effect of the timing of daily Helianthus tuberosus ingestion on postprandial and 24 h glucose levels, as well as on intestinal microbiota in older adults. In total, 37 healthy older adults (age = 74.9 ± 0.8 years) were recruited. The participants were randomly assigned to either a morning group (MG, n = 18) or an evening group (EG, n = 17). The MG and EG groups were instructed to take Helianthus tuberosus powder (5 g/day) just before breakfast or dinner, respectively, for 1 week after the 1-week control period. The glucose levels of all participants were monitored using a continuous glucose monitoring system throughout the 2 weeks. The intestinal microbiota was analyzed by sequencing 16S rRNA genes from feces before and after the intervention. There were no significant differences in the physical characteristics or energy intake between groups. Helianthus tuberosus intake led to decreases in tissue glucose levels throughout the day in both groups ( p < 0.01, respectively). As a result of examining the fluctuations in tissue glucose levels up to 4 hours after each meal, significant decreases in the areas under the curves (AUCs) were observed for all three meals after intervention, but only in the MG (breakfast: p = 0.012, lunch: p = 0.002, dinner: p = 0.005). On the other hand, in the EG, there was a strong decrease in the AUC after dinner, but only slight decreases after breakfast and lunch (breakfast: p = 0.017, lunch: p = 0.427, dinner: p = 0.002). Moreover, the rate of change in the peak tissue glucose level at breakfast was significantly decreased in the MG compared to the EG ( p = 0.027). A greater decrease was observed in the change in the blood glucose level after the ingestion of Helianthus tuberosus in the MG than in the EG. Furthermore, the relative abundance of Ruminococcus in the MG at the genus level was significantly higher at baseline than in the EG ( p = 0.016) and it was also significantly lower after the intervention ( p = 0.013). Our findings indicate that Helianthus tuberosus intake in the morning might have relatively stronger effects on the intestinal microbiota and suppress postprandial glucose levels to a greater extent than when taken in the evening.",2020,"Helianthus tuberosus intake led to decreases in tissue glucose levels throughout the day in both groups ( p < 0.01, respectively).","['older adults', '37 healthy older adults (age = 74.9 ± 0.8 years) were recruited', 'Older Adults']","['morning group (MG, n = 18) or an evening group (EG, n = 17', 'Ingestion of Helianthus tuberosus at Breakfast']","['rate of change in the peak tissue glucose level at breakfast', 'glucose levels', 'postprandial glucose levels', 'blood glucose level', 'relative abundance of Ruminococcus', 'tissue glucose levels', 'intestinal microbiota', 'postprandial and 24 h glucose levels', 'physical characteristics or energy intake']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0022386', 'cui_str': 'Jerusalem artichoke'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0318074', 'cui_str': 'Ruminococcus'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",37.0,0.0193183,"Helianthus tuberosus intake led to decreases in tissue glucose levels throughout the day in both groups ( p < 0.01, respectively).","[{'ForeName': 'Hyeon-Ki', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Faculty of Science and Engineering, Waseda University, 2-2 Wakamatsu-cho, Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Hanako', 'Initials': 'H', 'LastName': 'Chijiki', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 1628480, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Nanba', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 1628480, Japan.'}, {'ForeName': 'Mamiho', 'Initials': 'M', 'LastName': 'Ozaki', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 1628480, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sasaki', 'Affiliation': 'Faculty of Science and Engineering, Waseda University, 2-2 Wakamatsu-cho, Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Institute for Liberal Arts, Tokyo Institute of Technology, 2-12-1, Ookayama Meguro-ku, Tokyo 152-8550, Japan.'}, {'ForeName': 'Shigenobu', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Faculty of Science and Engineering, Waseda University, 2-2 Wakamatsu-cho, Shinjuku, Tokyo 162-8480, Japan.'}]",Nutrients,['10.3390/nu12103035']
3095,33022991,An Almond-Based Low Carbohydrate Diet Improves Depression and Glycometabolism in Patients with Type 2 Diabetes through Modulating Gut Microbiota and GLP-1: A Randomized Controlled Trial.,"BACKGROUND
Alow carbohydrate diet (LCD) is more beneficial for the glycometabolism in type 2 diabetes (T2DM) and may be effective in reducing depression. Almond, which is a common nut, has been shown to effectively improve hyperglycemia and depression symptoms. This study aimed to determine the effect of an almond-based LCD (a-LCD) on depression and glycometabolism, as well as gut microbiota and fasting glucagon-like peptide 1 (GLP-1) in patients with T2DM.
METHODS
This was a randomized controlled trial which compared an a-LCD with a low-fat diet (LFD). Forty-five participants with T2DM at a diabetes club and the Endocrine Division of the First and Second Affiliated Hospital of Soochow University between December 2018 to December 2019 completed each dietary intervention for 3 months, including 22 in the a-LCD group and 23 in the LFD group. The indicators for depression and biochemical indicators including glycosylated hemoglobin (HbA1c), gut microbiota, and GLP-1 concentration were assessed at the baseline and third month and compared between the two groups.
RESULTS
A-LCD significantly improved depression and HbA1c ( p <0.01). Meanwhile, a-LCD significantly increased the short chain fatty acid (SCFAs)-producing bacteria Roseburia , Ruminococcus and Eubacterium . The GLP-1 concentration in the a-LCD group was higher than that in the LFD group ( p <0.05).
CONCLUSIONS
A-LCD could exert a beneficial effect on depression and glycometabolism in patients with T2DM. We speculate that the role of a-LCD in improving depression in patients with T2DM may be associated with it stimulating the growth of SCFAs-producing bacteria, increasing SCFAs production and GPR43 activation, and further maintaining GLP-1 secretion. In future studies, the SCFAs and GPR43 activation should be further examined.",2020,A-LCD significantly improved depression and HbA1c ( p <0.01).,"['Affiliated Hospital of Soochow University between December 2018 to December 2019 completed each dietary intervention for 3 months, including 22 in the a-LCD group and 23 in the LFD group', 'Forty-five participants with T2DM at a diabetes club and the Endocrine Division of the First and Second', 'Patients with Type 2 Diabetes through Modulating Gut Microbiota and GLP-1', 'patients with T2DM']","['LFD', 'LCD with a low-fat diet (LFD', 'Almond-Based Low Carbohydrate Diet', 'almond-based LCD (a-LCD', 'Alow carbohydrate diet (LCD']","['hyperglycemia and depression symptoms', 'glycosylated hemoglobin (HbA1c), gut microbiota, and GLP-1 concentration', 'GLP-1 concentration', 'depression and HbA1c', 'short chain fatty acid (SCFAs)-producing bacteria Roseburia , Ruminococcus and Eubacterium ']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0440286', 'cui_str': 'Almond'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1690006', 'cui_str': 'Lattice corneal dystrophy Type I'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C1690006', 'cui_str': 'Lattice corneal dystrophy Type I'}, {'cui': 'C0440286', 'cui_str': 'Almond'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0301577', 'cui_str': 'Carbohydrate diet'}]","[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}, {'cui': 'C0318074', 'cui_str': 'Ruminococcus'}, {'cui': 'C0015146', 'cui_str': 'Eubacterium'}]",45.0,0.0354016,A-LCD significantly improved depression and HbA1c ( p <0.01).,"[{'ForeName': 'Mengxiao', 'Initials': 'M', 'LastName': 'Ren', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Huaiyu', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Medicine, University of California, San Francisco, CA 94110, USA.'}, {'ForeName': 'Jindan', 'Initials': 'J', 'LastName': 'Qi', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Yunying', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Omorogieva', 'Initials': 'O', 'LastName': 'Ojo', 'Affiliation': 'School of Health Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, London SE9 2UG, UK.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}]",Nutrients,['10.3390/nu12103036']
3096,33023894,Combination Treatment with Sodium Nitrite and Isoquercetin on Endothelial Dysfunction among Patients with CKD: A Randomized Phase 2 Pilot Trial.,"BACKGROUND AND OBJECTIVES
Endothelial dysfunction is common among patients with CKD. We tested the efficacy and safety of combination treatment with sodium nitrite and isoquercetin on biomarkers of endothelial dysfunction in patients with CKD.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS
This randomized, double-blind, placebo-controlled phase 2 pilot trial enrolled 70 patients with predialysis CKD. Thirty-five were randomly assigned to combination treatment with sodium nitrite (40 mg twice daily) and isoquercetin (225 mg once daily) for 12 weeks, and 35 were randomly assigned to placebo. The primary outcome was mean change in flow-mediated vasodilation over the 12-week intervention. Secondary and safety outcomes included biomarkers of endothelial dysfunction, inflammation, and oxidative stress as well as kidney function, methemoglobin, and adverse events. Intention-to-treat analysis was conducted.
RESULTS
Baseline characteristics, including age, sex, race, cigarette smoking, history of hypertension and diabetes, use of renin-angiotensin system blockers, BP, fasting glucose, lipid profile, kidney function, urine albumin-creatinine ratio, and endothelial biomarkers, were comparable between groups. Over the 12-week intervention, flow-mediated vasodilation increased 1.1% (95% confidence interval, -0.1 to 2.3) in the treatment group and 0.3% (95% confidence interval, -0.9 to 1.5) in the placebo group, and net change was 0.8% (95% confidence interval, -0.9 to 2.5). In addition, changes in biomarkers of endothelial dysfunction (vascular adhesion molecule-1, intercellular adhesion molecule-1, E-selectin, vWf, endostatin, and asymmetric dimethylarginine), inflammation (TNF- α , IL-6, C-reactive protein, IL-1 receptor antagonist, and monocyte chemoattractant protein-1), and oxidative stress (oxidized LDL and nitrotyrosines) were not significantly different between the two groups. Furthermore, changes in eGFR, urine albumin-creatinine ratio, methemoglobin, and adverse events were not significantly different between groups.
CONCLUSIONS
This randomized phase 2 pilot trial suggests that combination treatment with sodium nitrite and isoquercetin did not significantly improve flow-mediated vasodilation or other endothelial function biomarkers but also did not increase adverse events compared with placebo among patients with CKD.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER
Nitrite, Isoquercetin, and Endothelial Dysfunction (NICE), NCT02552888.",2020,"Over the 12-week intervention, flow-mediated vasodilation increased 1.1% (95% confidence interval, -0.1 to 2.3) in the treatment group and 0.3% (95% confidence interval, -0.9 to 1.5) in the placebo group, and net change was 0.8% (95% confidence interval, -0.9 to 2.5).","['70 patients with predialysis CKD', 'patients with CKD', 'Thirty-five', 'Patients with CKD']","['sodium nitrite and isoquercetin', 'isoquercetin', 'Sodium Nitrite and Isoquercetin', 'placebo', 'sodium nitrite']","['flow-mediated vasodilation or other endothelial function biomarkers', 'efficacy and safety', 'biomarkers of endothelial dysfunction, inflammation, and oxidative stress as well as kidney function, methemoglobin, and adverse events', 'age, sex, race, cigarette smoking, history of hypertension and diabetes, use of renin-angiotensin system blockers, BP, fasting glucose, lipid profile, kidney function, urine albumin-creatinine ratio, and endothelial biomarkers', 'endothelial dysfunction (vascular adhesion molecule-1, intercellular adhesion molecule-1, E-selectin, vWf, endostatin, and asymmetric dimethylarginine), inflammation (TNF- α , IL-6, C-reactive protein, IL-1 receptor antagonist, and monocyte chemoattractant protein-1), and oxidative stress (oxidized LDL and nitrotyrosines', 'eGFR, urine albumin-creatinine ratio, methemoglobin, and adverse events', 'endothelial dysfunction', 'mean change in flow-mediated vasodilation', 'flow-mediated vasodilation', 'Endothelial Dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C4319605', 'cui_str': '35'}]","[{'cui': 'C0037532', 'cui_str': 'Sodium Nitrite'}, {'cui': 'C3891959', 'cui_str': 'isoquercetin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0025635', 'cui_str': 'Methemoglobin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0455271', 'cui_str': 'Urine albumin/creatinine ratio measurement'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0534628', 'cui_str': 'Endostatin'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0063710', 'cui_str': 'Interleukin 1 Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0047645', 'cui_str': '3-nitrotyrosine'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",70.0,0.551589,"Over the 12-week intervention, flow-mediated vasodilation increased 1.1% (95% confidence interval, -0.1 to 2.3) in the treatment group and 0.3% (95% confidence interval, -0.9 to 1.5) in the placebo group, and net change was 0.8% (95% confidence interval, -0.9 to 2.5).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana jchen@tulane.edu.'}, {'ForeName': 'L Lee', 'Initials': 'LL', 'LastName': 'Hamm', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Bundy', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Damodar R', 'Initials': 'DR', 'LastName': 'Kumbala', 'Affiliation': 'Renal Associates of Baton Rouge, Baton Rouge, Louisiana.'}, {'ForeName': 'Shirisha', 'Initials': 'S', 'LastName': 'Bodana', 'Affiliation': 'Department of Nephrology, Ochsner Health System, New Orleans, Louisiana.'}, {'ForeName': 'Sehgal', 'Initials': 'S', 'LastName': 'Chandra', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Chung-Shiuan', 'Initials': 'CS', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana jchen@tulane.edu.'}, {'ForeName': 'Charlton C', 'Initials': 'CC', 'LastName': 'Starcke', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Schaefer', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Lustigova', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Mahone', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Aarti M', 'Initials': 'AM', 'LastName': 'Vadalia', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Terra', 'Initials': 'T', 'LastName': 'Livingston', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Obst', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Syed Rizwan', 'Initials': 'SR', 'LastName': 'Bokhari', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Kleinpeter', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Arnold B', 'Initials': 'AB', 'LastName': 'Alper', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Lukitsch', 'Affiliation': 'Department of Nephrology, Ochsner Health System, New Orleans, Louisiana.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana jchen@tulane.edu.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Nieman', 'Affiliation': 'Human Performance Lab, Appalachian State University, Kannapolis, North Carolina.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana jchen@tulane.edu.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.02020220']
3097,33023898,Long-term metformin adherence in the Diabetes Prevention Program Outcomes Study.,"INTRODUCTION
To investigate long-term metformin adherence in the Diabetes Prevention Program Outcomes Study (DPPOS) by examining: (1) predictors of long-term adherence to study metformin and (2) whether metformin adherence was associated with incident type 2 diabetes.
RESEARCH DESIGN AND METHODS
DPPOS was an open-label continuation of the randomized clinical trial (Diabetes Prevention Program (DPP)) in which eligible participants randomized to the metformin group were offered study metformin and followed over 11 years. A brief structured adherence interview was administered semiannually. Metformin adherence was assessed by pill counts. Predictors of metformin adherence were examined in multivariate regression models. Incident diabetes associated with metformin adherence and other variables was assessed in Cox proportional hazards models.
RESULTS
Of 868 participants eligible to continue taking study metformin, 664 (76%) took at least some metformin over 11 years, with 478 of them reporting problems with adherence. DPPOS cumulative adherence showed significant associations of higher adherence (≥80%) with early adherence at 3 months in DPP (p<0.001) and lower depression scores during DPPOS (p<0.001); significant differences were also seen by race/ethnicity (p<0.004). Predicting adherence by multivariate modeling showed odds of adherence significantly lower for Black participants and for participants reporting more than one barrier. Odds for adherence were significantly higher for those adherent early in DPP and those reporting at least one planned strategy to improve adherence. Higher metformin adherence was significantly associated with a lower diabetes risk (p=0.04), even after adjustment for demographic variables, depression, and anxiety scores.
CONCLUSIONS
In this long-term diabetes prevention study, early metformin adherence and planned strategies to promote adherence improved long-term adherence over 11 years; higher adherence to metformin was related to lower diabetes incidence. Incorporating strategies to promote adherence when initially prescribing metformin and counseling to support adherence over time are warranted.",2020,Odds for adherence were significantly higher for those adherent early in DPP and those reporting at least one planned strategy to improve adherence.,"['868 participants eligible to continue taking study metformin, 664 (76%) took at least some metformin over 11 years, with 478 of them reporting problems with adherence']","['Diabetes Prevention Program (DPP', 'metformin']","['Metformin adherence', 'Odds for adherence', 'lower diabetes risk', 'depression scores', 'demographic variables, depression, and anxiety scores']","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",868.0,0.022693,Odds for adherence were significantly higher for those adherent early in DPP and those reporting at least one planned strategy to improve adherence.,"[{'ForeName': 'Elizabeth Arquin', 'Initials': 'EA', 'LastName': 'Walker', 'Affiliation': 'Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Gonzalez', 'Affiliation': 'Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Tripputi', 'Affiliation': 'The Biostatistics Center, The George Washington University Milken Institute of Public Health, Washington, District of Columbia, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dagogo-Jack', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism General Clinical Research Center, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'Matulik', 'Affiliation': 'Medicine, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Montez', 'Affiliation': 'Medicine, University of Texas Health Sciences Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Sameh', 'Initials': 'S', 'LastName': 'Tadros', 'Affiliation': 'Medicine, University of California at Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Edelstein', 'Affiliation': 'The Biostatistics Center, The George Washington University Milken Institute of Public Health, Washington, District of Columbia, USA dppmail@bsc.gwu.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001537']
3098,33032123,"The effect of emergency manuals on team performance during two different simulated perioperative crises: A prospective, randomized controlled trial.","STUDY OBJECTIVE
Whether having an emergency manual (EM) available for use during perioperative crises enhances or detracts from team performance, especially for multi-factorial diagnostic situations that do not explicitly match a chapter of the EM.
DESIGN
A simulation-based, prospective randomized trial based upon two perioperative crises, one involving a patient with a transfusion reaction for which the EM contains a specific chapter, and the other involving a patient with refractory hypotension progressing into septic shock for which the EM does not have a specific chapter.
SETTING
52 regularly scheduled 6-h courses at the Center for Medical Simulation in Boston, Massachusetts, USA.
STUDY GROUP
304 US-trained practicing anesthesiologists.
INTERVENTIONS
The absence or presence of the EM during the simulation case.
MEASUREMENTS
Teams were rated in the following categories: primary underlying diagnosis, fluid resuscitation, treatment of primary diagnosis, cardiac arrest management, overall crisis management, and (if applicable) EM usage. Also, raters recorded free-text 'field notes' about the usage-patterns and perceived utility of the EM. Using these 'field notes' and a two-stage, inductively revised procedure, two independent reviewers examined a subset of case videos for action analysis.
MAIN RESULTS
Performance ratings for a total of 51 teams and 95 simulations were included in the final analysis. No effect on performance was demonstrated with providing the EM in either the refractory hypotension/septic shock case or the transfusion reaction case, with the exception of the PEA arrest category. In the subset of simulations in which resuscitation from PEA arrest performance could be evaluated, EM availability was associated with an adjusted mean 1.3 point (99% confidence interval [CI]: 0.2, 2.4) improvement in performance in the transfusion reaction case (p = 0.004), but only an adjusted mean 0.2 point (99% CI, -0.7, 1.1) improvement in the refractory hypotension/septic shock case (p = 0.530) (p for interaction = 0.069). Analysis of actions found that when available, the EM was usually used, but often not until after cardiac arrest had occurred. In some cases, teams persisted with incorrect diagnoses and treatments irrespective of the presence or absence of an EM.
CONCLUSIONS
Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist. A suggestion of improved cardiac arrest resuscitation with the availability of an EM was found, but should be interpreted with caution given a limited sample size. Observed actions using the EM demonstrated that only about half of the teams used the EM to any substantive degree and most used it relatively late in the crisis. By observation, the EM appeared to be helpful in about half of the cases and did not, by itself, deter from appropriate management.",2020,"Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist.","['patient with a transfusion reaction for which the EM contains a specific chapter, and the other involving a patient with refractory hypotension progressing into septic shock for which the EM does not have a specific chapter', 'two different simulated perioperative crises', '52']",[],"['diagnosis, fluid resuscitation, treatment of primary diagnosis, cardiac arrest management, overall crisis management, and (if applicable) EM usage', 'refractory hypotension/septic shock case', 'EM availability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0274435', 'cui_str': 'Blood transfusion reaction'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4304283', 'cui_str': 'Refractory hypotension'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C1272460', 'cui_str': 'Not applicable'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C4304283', 'cui_str': 'Refractory hypotension'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",52.0,0.125845,"Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist.","[{'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Urman', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America; Center for Perioperative Research, Brigham and Women's Hospitals, Boston, MA, United States of America. Electronic address: rurman@bwh.harvard.edu.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'August', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Chung', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Amanda H', 'Initials': 'AH', 'LastName': 'Jiddou', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Buckley', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Kara G', 'Initials': 'KG', 'LastName': 'Fields', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'J Bradley', 'Initials': 'JB', 'LastName': 'Morrison', 'Affiliation': 'Brandeis International Business School, Waltham, MA, United States of America.'}, {'ForeName': 'Janice C', 'Initials': 'JC', 'LastName': 'Palaganas', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raemer', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110080']
3099,33032163,"Recovery using ""float"" from high intensity stress on growth hormone-like molecules in resistance trained men.","OBJECTIVE
The purpose of this study was to examine the influence of a novel ""floatation-restricted environmental stimulation therapy"" (floatation-REST) on growth hormone responses to an intense resistance exercise stress.
DESIGN
Nine resistance trained men (age: 23.4 ± 2.5 yrs.; height: 175.3 ± 5.4 cm; body mass: 85.3 ± 7.9 kg) completed a balanced, crossover-controlled study design with two identical exercise trials, differing only in post-exercise recovery intervention (i.e., control or floatation-REST). A two-week washout period was used between experimental conditions. Plasma lactate was measured pre-exercise, immediately post-exercise and after the 1 h. recovery interventions. Plasma iGH was measured pre-exercise, immediately-post exercise, and after the recovery intervention, as well as 24 h and 48 h after the exercise test. The bGH-L was measured only at pre-exercise and following each recovery intervention.
RESULTS
For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (~14 mmol • L-1) and remained slightly elevated after the recovery condition. The same pattern of responses was observed for iGH with no differences from resting values at 24 and 48 h of recovery. The bGH-L showed no exercise-induced changes following recovery with either treatment condition, however concentration values were dramatically lower than ever reported.
CONCLUSION
The use of floatation-REST therapy immediately following intense resistance exercise does not appear to influence anterior pituitary function in highly resistance trained men. However, the lower values of bGH suggest dramatically different molecular processing mechanisms at work in this highly trained population.",2020,"For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (","['Nine resistance trained men (age: 23.4\u202f±\u202f2.5\u202fyrs', '14', ' height: 175.3\u202f±\u202f5.4\u202fcm; body mass: 85.3\u202f±\u202f7.9\u202fkg', 'highly resistance trained men', 'resistance trained men']","['novel ""floatation-restricted environmental stimulation therapy"" (floatation-REST', 'floatation-REST therapy', 'exercise recovery intervention (i.e., control or floatation-REST']","['Plasma iGH', 'bGH-L', 'Plasma lactate', 'lactate concentrations', 'concentration values']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017351', 'cui_str': 'Immunoglobulin gene GM allotype'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",9.0,0.0688166,"For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kraemer', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America. Electronic address: kraemer.44@osu.edu.'}, {'ForeName': 'Lydia K', 'Initials': 'LK', 'LastName': 'Caldwell', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Post', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Beeler', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Dickerson', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kennett', 'Affiliation': 'Department of Veterinary and Biomedical Sciences, The Pennsylvania State University, University Park, PA 16802, United States of America.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Volek', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Maresh', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Wesley C', 'Initials': 'WC', 'LastName': 'Hymer', 'Affiliation': 'Department of Biochemistry and Molecular Biology, The Pennsylvania State University, University Park, PA 16802, United States of America.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101355']
3100,33032164,"Exploring the impact of a liquefied petroleum gas intervention on time use in rural Peru: A mixed methods study on perceptions, use, and implications of time savings.","BACKGROUND
Efforts to promote clean cooking through adoption of clean-burning fuels such as liquefied petroleum gas (LPG) are often based on the idea that near-exclusive use of LPG could lead to health improvements. However, benefits beyond health, such as time savings, could be more tangible and meaningful to LPG users.
OBJECTIVES
This study investigated the effect of an LPG intervention on time spent cooking and collecting fuel, using objective measures of stove temperatures combined with self-reports under conditions of near-exclusive LPG use. We also investigated the perceived value of any time savings and potential economic and quality of life implications.
METHODS
We analyzed data from the Cardiopulmonary outcomes and Household Air Pollution trial in Puno, Peru, a randomized controlled trial with 180 participants assessing exposure and health impacts of an LPG stove, fuel, and behavioral intervention. Surveys conducted with 90 intervention women receiving free LPG and 90 control women cooking primarily with biomass assessed time spent cooking and collecting biomass fuel and use of time savings. Cooking time was objectively measured with temperature sensors on all stoves. Qualitative interviews explored perceptions and use of time savings in more depth.
RESULTS
Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day. Participants perceived time saved from LPG positively, reporting more time for household chores, leisure activities, and activities with income-generating potential such as caring for animals and working in fields.
DISCUSSION
This paper suggests that the benefits of LPG extend beyond health and the environment. LPG use could also lead to economic and quality of life gains, through increased time for work, rest, and consumption of hot meals, and reduced arduous biomass fuel collection.",2020,"RESULTS
Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day.","['180 participants assessing exposure and health impacts of an LPG stove, fuel, and behavioral intervention', '90 intervention women receiving free LPG and 90 control women cooking primarily with biomass assessed', 'rural Peru']","['LPG', 'liquefied petroleum gas intervention', 'LPG intervention']","['time for work, rest, and consumption of hot meals, and reduced arduous biomass fuel collection', 'time spent cooking and collecting biomass fuel and use of time savings', 'time saved from LPG positively, reporting more time for household chores, leisure activities, and activities with income-generating potential such as caring for animals and working in fields', 'Cooking time', 'time savings and potential economic and quality of life implications']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",180.0,0.0503954,"RESULTS
Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day.","[{'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA. Electronic address: kendra.williams@jhu.edu.'}, {'ForeName': 'Josiah L', 'Initials': 'JL', 'LastName': 'Kephart', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA; Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Fandiño-Del-Rio', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA; Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Simkovich', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Harvey', 'Affiliation': 'Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environment international,['10.1016/j.envint.2020.105932']
3101,33037644,Educating junior doctors and pharmacists to reduce discharge prescribing of opioids for surgical patients: a cluster randomised controlled trial.,"OBJECTIVES
To evaluate whether educating junior doctors and hospital pharmacists about analgesic prescribing improved discharge prescribing of opioids for opioid-naïve patients after surgical admissions.
DESIGN
Cluster randomised controlled trial, undertaken during the first half of 2019.
SETTING
The Alfred Hospital, a major Melbourne teaching hospital with 13 surgical units.
PARTICIPANTS
Opioid-naïve patients discharged from surgical units after a stay of at least 24 hours.
INTERVENTION
Surgical units were randomised to the intervention or control arms. Interns, residents, and clinical pharmacists assigned to intervention arm units attended education sessions, presented by the hospital analgesic stewardship pharmacist, about appropriate analgesic prescribing for patients in hospital surgical units.
MAIN OUTCOME MEASURES
The patients prescribed slow release opioids on discharge from hospital during the baseline (1 February - 30 April 2018) and post-intervention periods (17 February - 30 April 2019).
RESULTS
During the baseline period, 1369 intervention unit and 1014 control unit admissions were included in our analysis; during the evaluation period, 973 intervention unit and 706 control unit episodes were included. After adjusting for age, length of stay, pain score, acute pain service involvement, and use of immediate release opioids prior to admission, patients in the intervention group were prescribed slow release opioids at discharge less frequently than patients in the control group (adjusted odds ratio [aOR], 0.52; 95% CI, 0.35-0.77) and were more frequently discharged without any prescribed opioids following the intervention (aOR, 1.69; 95% CI, 1.24-2.30). Providing de-escalation plans was more frequent for intervention than control group patients prescribed slow release opioids on discharge post-intervention (OR, 2.36; 95% CI, 1.25-4.45).
CONCLUSIONS
Specific education for clinicians and pharmacists about appropriate analgesic prescribing for surgical patients is effective in reducing prescribing of opioids at discharge.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry, ACTRN12618000876291 (prospective).",2020,"Providing de-escalation plans was more frequent for intervention than control group patients prescribed slow release opioids on discharge post-intervention (OR, 2.36; 95% CI, 1.25-4.45).
","['educating junior doctors and hospital pharmacists about analgesic prescribing improved discharge prescribing of opioids for opioid-naïve patients after surgical admissions', 'Opioid-naïve patients discharged from surgical units after a stay of at least 24 hours', 'patients prescribed slow release opioids on discharge from hospital during the baseline (1 February - 30 April 2018) and post-intervention periods (17 February - 30 April 2019', 'surgical patients', '1369 intervention unit and 1014 control unit admissions were included in our analysis; during the evaluation period, 973 intervention unit and 706 control unit episodes were included', 'The Alfred Hospital, a major Melbourne teaching hospital with 13 surgical units']",[],"['length of stay, pain score, acute pain service involvement', 'slow release opioids']","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0402002', 'cui_str': 'Hospital pharmacist'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3873701', 'cui_str': 'Control unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]",[],"[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0242934', 'cui_str': 'Acute pain service'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",,0.113927,"Providing de-escalation plans was more frequent for intervention than control group patients prescribed slow release opioids on discharge post-intervention (OR, 2.36; 95% CI, 1.25-4.45).
","[{'ForeName': 'Ria E', 'Initials': 'RE', 'LastName': 'Hopkins', 'Affiliation': 'Alfred Health, Melbourne, VIC.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Bui', 'Affiliation': 'Alfred Health, Melbourne, VIC.'}, {'ForeName': 'Alex H', 'Initials': 'AH', 'LastName': 'Konstantatos', 'Affiliation': 'Alfred Health, Melbourne, VIC.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Arnold', 'Affiliation': 'Alfred Health, Melbourne, VIC.'}, {'ForeName': 'Dianna J', 'Initials': 'DJ', 'LastName': 'Magliano', 'Affiliation': 'Baker IDI Heart and Diabetes Institute, Melbourne, VIC.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Liew', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Dooley', 'Affiliation': 'Alfred Health, Melbourne, VIC.'}]",The Medical journal of Australia,['10.5694/mja2.50812']
3102,33037656,Effect of recombinant human growth hormone on liver fat content in young adults with nonalcoholic fatty liver disease.,"BACKGROUND
Nonalcoholic fatty liver disease (NAFLD) is highly prevalent in young adults with obesity. Obesity is associated with relative growth hormone (GH) deficiency, and data from animal studies and from humans with pituitary GH deficiency suggest a role for GH deficiency in the pathogenesis of NAFLD. The effects of GH on NAFLD in those with obesity are unknown, however, prompting this pilot study to assess effects of GH administration on measures of NAFLD in young adults.
METHODS
Twenty-four men and women aged 18-29 years with BMI ≥ 30 kg/m 2 , hepatic fat fraction (HFF) ≥ 5% on proton magnetic resonance spectroscopy ( 1 H-MRS) and insulin-like growth factor 1 (IGF-1) z-score ≤ 0 were randomized to treatment with recombinant human GH (rhGH) versus no treatment for 24 weeks. The primary endpoint was change in HFF.
RESULTS
Compared to no treatment, the effect size of rhGH on absolute HFF over 24 weeks was -3.3% (95% confidence interval: -7.8%, 1.2%; p = .14). At 24 weeks, HFF < 5% was achieved in 5 of 9 individuals receiving rhGH versus 1 of 9 individuals receiving no treatment (p = .04). rhGH did not significantly reduce ALT, AST or GGT. Serum IGF-1 increased as expected with rhGH treatment, and there were no changes in fasting lipids, C-reactive protein, fasting glucose or 2-h glucose following an oral glucose tolerance test.
CONCLUSION
Data from this pilot study suggest that rhGH treatment in young adults with obesity and NAFLD may have benefits to reduce liver fat content, although larger studies are needed to confirm this effect.",2020,"At 24 weeks, HFF < 5% was achieved in 5 of 9 individuals receiving rhGH versus 1 of 9 individuals receiving no treatment (p = .04).","['Twenty-four men and women aged 18-29\xa0years with BMI\xa0≥\xa030\xa0kg/m 2 , hepatic fat fraction (HFF', 'young adults with obesity', 'young adults', 'young adults with obesity and NAFLD', 'young adults with nonalcoholic fatty liver disease']","['recombinant human GH (rhGH', 'GH', 'recombinant human growth hormone', 'proton magnetic resonance spectroscopy ( 1 H-MRS) and insulin-like growth factor 1', 'rhGH']","['change in HFF', 'effect size of rhGH on absolute HFF', 'fasting lipids, C-reactive protein, fasting glucose or 2-h glucose following an oral glucose tolerance test', 'liver fat content', 'Serum IGF-1', 'ALT, AST or GGT']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}]",24.0,0.0711934,"At 24 weeks, HFF < 5% was achieved in 5 of 9 individuals receiving rhGH versus 1 of 9 individuals receiving no treatment (p = .04).","[{'ForeName': 'Chelsea S', 'Initials': 'CS', 'LastName': 'Pan', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Julian J', 'Initials': 'JJ', 'LastName': 'Weiss', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Lindsay T', 'Initials': 'LT', 'LastName': 'Fourman', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Buckless', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Branch', 'Affiliation': 'Translational and Clinical Research Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Torriani', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Madhusmita', 'Initials': 'M', 'LastName': 'Misra', 'Affiliation': 'Pediatric Endocrine Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Takara L', 'Initials': 'TL', 'LastName': 'Stanley', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}]",Clinical endocrinology,['10.1111/cen.14344']
3103,33023491,The effects of neostigmine on postoperative cognitive function and inflammatory factors in elderly patients - a randomized trial.,"BACKGROUND
Postoperative cognitive dysfunction is a common postoperative complication in elderly patients. In elderly patients, the decline of organ function and neuromuscular junction function make them more sensitive to muscle relaxants. They are more likely to experience residual muscle relaxation after surgery, which may cause various adverse events. Neostigmine, a commonly used muscle relaxant antagonist, can reduce the expression of inflammatory factors, thereby reducing the pro-inflammatory response and neurodegeneration of the cerebral cortex and hippocampus after surgery. The study aimed at observing the effect of different doses of neostigmine on postoperative cognitive function and peripheral inflammatory factors in elderly patients.
METHODS
One hundred thirty-two elderly patients who underwent a radical section of gastrointestinal cancer at First Affiliated Hospital of Dalian Medical University were divided into neostigmine and saline groups at a 2:1 ratio. Neostigmine was intravenously injected in the post-anesthesia care unit (PACU) according to the train-of-four ratio (TOFR) T4/T1. When TOFR was ≤0.5, 0.04 mg/kg neostigmine was administered, whereas when TOFR was > 0.5, 0.02 mg/kg neostigmine was injected. The main observation indexes were cognitive function, interleukin 1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and interleukin 6 (IL-6) in peripheral blood at the different times before and after the surgery. Secondary observation indicators include the number of atropine injection, extubating time, PACU residence time, incidence of hypoxemia, hypercapnia, and postoperative nausea and vomiting in PACU, time of exhaustion, and length of hospitalization.
RESULTS
The extubating and PACU times in 0.04 mg/kg and 0.02 mg/kg groups were significantly shorter than those in the control group (P < 0.001). The incidence of early postoperative cognitive decline in 0.04 mg/kg and 0.02 mg/kg groups was 10 and 15.7%, respectively, which were significantly lower than those in the control group (P = 0.013).
CONCLUSION
In elderly patients, 0.02-0.04 mg/kg neostigmine could significantly reduce the incidence of early postoperative cognitive decline without affecting peripheral inflammatory factors.
TRIAL REGISTRATION
Trial registration: Chinese Clinical Trial Registry, ChiCTR2000031739. Registered 8 April 2020 - Retrospectively registered, http://www.medresman.org.cn .",2020,"The main observation indexes were cognitive function, interleukin 1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and interleukin 6 (IL-6) in peripheral blood at the different times before and after the surgery.","['elderly patients ', 'One hundred thirty-two elderly patients who underwent a radical section of gastrointestinal cancer at First Affiliated Hospital of Dalian Medical University', 'elderly patients']","['neostigmine', 'neostigmine and saline', 'Neostigmine']","['postoperative cognitive function and inflammatory factors', 'cognitive function, interleukin 1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and interleukin 6 (IL-6) in peripheral blood', 'extubating and PACU times', 'organ function and neuromuscular junction function', 'postoperative cognitive function and peripheral inflammatory factors', 'incidence of early postoperative cognitive decline', 'number of atropine injection, extubating time, PACU residence time, incidence of hypoxemia, hypercapnia, and postoperative nausea and vomiting in PACU, time of exhaustion, and length of hospitalization']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0027869', 'cui_str': 'Neuromuscular junction'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4051550', 'cui_str': 'Atropine Injection'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",132.0,0.127947,"The main observation indexes were cognitive function, interleukin 1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and interleukin 6 (IL-6) in peripheral blood at the different times before and after the surgery.","[{'ForeName': 'Bao', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Department of anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, 116011, China.'}, {'ForeName': 'Defeng', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, 116011, China. sundefengyl@163.com.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Neuroelectrophysiology, The First Affiliated Hospital of Dalian Medical University, Dalian, 116011, China.'}, {'ForeName': 'Zhongliang', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, 116011, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, 116011, China.'}, {'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Department of anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, 116011, China.'}]",BMC geriatrics,['10.1186/s12877-020-01793-4']
3104,33023497,Interprofessional medication assessment among home care patients: any impact on functioning? Results from a randomised controlled trial.,"BACKGROUND
Multimorbidity and polypharmacy are related to the use of potentially inappropriate medicines and negative clinical outcomes including drug-related adverse events and functional declines. Home care clients are a vulnerable patient group often exposed to these risks. The aim of this study was to examine whether an interprofessional medication assessment can influence the functioning of home care patients.
METHODS
The FIMA study was a randomised controlled intervention study comparing a general practitioner-led interprofessional medication assessment conducted at the baseline of the study with usual care with a six-month follow-up. We used linear mixed models (LMM) with a random subject effect to detect differences between the usual care and intervention groups in the following outcome measures; Katz index of Activities of Daily Living (ADL), Lawton and Brody scale of Instrumental Activities of Daily Living, Timed up and go-test (TUG), Mini-Mental State Examination, Geriatric Depression Scale and the 3-level version of EQ-5D.
RESULTS
Home care patients (n = 512) had major disease burdens and functional limitations. Regarding TUG times, the LMM detected a one second improvement in the FIMA group and 2.4 s worsening in the usual care group. However, the result was not statistically significant. The ADL revealed an interaction across time, treatment and sex (p = 0.026). The ADL score decreased in both groups; the decline being the steepest among women in the intervention group.
CONCLUSIONS
In general, medication assessments may have limited impact on functioning of older people. Nonetheless, the FIMA intervention may prevent worsening of mobility among older home care patients.
TRIAL REGISTRATION
The Interprofessional Medication Assessment for Older Patients, Clinical Trials.gov. NCT02398812 . First registration, 26 March 2015. Retrospectively registered.",2020,"Regarding TUG times, the LMM detected a one second improvement in the FIMA group and 2.4 s worsening in the usual care group.","['home care patients', 'Older Patients, Clinical Trials.gov', 'older home care patients', 'general practitioner-led interprofessional medication assessment conducted at the baseline of the study with usual care with a six-month follow-up']",['FIMA intervention'],"['Katz index of Activities of Daily Living (ADL), Lawton and Brody scale of Instrumental Activities of Daily Living, Timed up and go-test (TUG), Mini-Mental State Examination, Geriatric Depression Scale and the 3-level version of EQ-5D', 'ADL score', 'major disease burdens and functional limitations']","[{'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0451239', 'cui_str': 'Katz activities of daily living'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",,0.0632623,"Regarding TUG times, the LMM detected a one second improvement in the FIMA group and 2.4 s worsening in the usual care group.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Auvinen', 'Affiliation': 'The East Savo Hospital District, BOX 111, FI-57101, Savonlinna, Finland. kati.auvinen@sosteri.fi.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Voutilainen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jyrkkä', 'Affiliation': 'Assessment of Pharmacotherapies, Finnish Medicines Agency, Kuopio, Finland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lönnroos', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mäntyselkä', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}]",BMC geriatrics,['10.1186/s12877-020-01796-1']
3105,31883218,"Associations between dietary patterns, eating behaviours, and body composition and adiposity in 3-year-old children of mothers with obesity.","BACKGROUND
The relationships between eating habits, behaviours, and the development of obesity in preschool children is not well established.
OBJECTIVE
As children of mothers with obesity are themselves at risk of obesity, we examined these relationships in a cohort of 482 three-year-old children of mothers with obesity from the UK Pregnancy Better Eating and Activity Trial (UPBEAT).
METHOD
Dietary patterns were derived using factor analysis of an 85-item food frequency questionnaire (FFQ). Eating behaviours were assessed using the Children's Eating Behaviour Questionnaire (CEBQ). Measures of body composition included age-specific BMI cut-offs, WHO z scores, sum of skinfolds, waist and arm circumferences, and body fat percentage. Using adjusted regression analysis, we examined associations between dietary patterns, eating behaviours, and measures of body composition.
RESULTS
Three distinct dietary patterns were defined: ""healthy/prudent,"" ""African/Caribbean,"" and ""processed/snacking."" The ""processed/snacking"" pattern was associated with greater odds of obesity; OR 1.53 (95% CI, 1.07-2.19). The ""African/Caribbean"" and the ""healthy/prudent"" patterns were associated with a lower arm circumference (β = -0.23 cm [-0.45 to -0.01]) and sum of skinfolds (β = -1.36 cm [-2.88 to -0.37]), respectively. Lower enjoyment of food and food responsiveness, and greater slowness in eating and satiety, were associated with lower arm and waist circumferences, WHO z scores, and obesity (all P < .05).
CONCLUSION
In children of mothers with obesity, those who had higher scores on a ""processed/snacking"" dietary pattern had greater odds of obesity. In contrast, slowness in eating was associated with lower measures of body composition. These novel findings highlight modifiable behaviours in high-risk preschool children which could contribute to public health strategies for prevention of childhood obesity.",2020,"The ""processed/snacking"" pattern was associated with greater odds of obesity; OR 1.53 (95% CI, 1.07-2.19).","['482 three-year-old children of mothers with obesity from the UK Pregnancy Better Eating and Activity Trial (UPBEAT', 'preschool children', 'high-risk preschool children', '3-year-old children of mothers with obesity']",[],"['lower arm and waist circumferences, WHO z scores, and obesity', 'dietary patterns, eating behaviours, and body composition and adiposity', 'Eating behaviours', 'obesity', 'body composition included age-specific BMI cut-offs, WHO z scores, sum of skinfolds, waist and arm circumferences, and body fat percentage', 'dietary patterns, eating behaviours, and measures of body composition', 'Lower enjoyment of food and food responsiveness, and greater slowness in eating and satiety', ""Children's Eating Behaviour Questionnaire (CEBQ""]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C1518543', 'cui_str': 'Off'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0611576,"The ""processed/snacking"" pattern was associated with greater odds of obesity; OR 1.53 (95% CI, 1.07-2.19).","[{'ForeName': 'Kathryn V', 'Initials': 'KV', 'LastName': 'Dalrymple', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Flynn', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Briley', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Majella', 'Initials': 'M', 'LastName': ""O'Keeffe"", 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'MRC Lifecourse Epidemiology Unit and NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Poston', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}]",Pediatric obesity,['10.1111/ijpo.12608']
3106,33027559,Comparison of breast cancer prognostic tests CanAssist Breast and Oncotype DX.,"BACKGROUND
CanAssist Breast (CAB) is a prognostic test for early stage hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer patients, validated on Indian and Caucasian patients. The 21-gene signature Oncotype DX (ODX) is the most widely used commercially available breast cancer prognostic test. In the current study, risk stratification of CAB is compared with that done with ODX along with the respective outcomes of these patients.
METHODS
A cohort of 109 early stage breast cancer patients who had previously taken the ODX test were retested with CAB, and the results respectively compared with old cut-offs of ODX as well as cut-offs suggested by TAILORx, a prospective randomized trial of ODX. Distant metastasis-free survival after 5 years was taken as the end point.
RESULTS
CanAssist Breast stratified 83.5% of the cohort into low-risk and 16.5% into high-risk. With the TAILORx cut-offs, ODX stratified the cohort into 89.9% low-risk and 10.1% into high-risk. The low, intermediate, and high-risk groups with ODX old cut-offs were 62.4%, 31.2%, and 6.4%, respectively. The overall concordance of CAB with ODX using both cut-offs is 75%-76%, with ~82%-83% concordance in the low-risk category of these tests. The NPV of the low-risk category of CAB was 93.4%, and of ODX with TAILORx cut-offs was 91.8% and 89.7% with old cut-offs.
CONCLUSIONS
Compared to the concordance reported for other tests, CAB shows high concordance with ODX, and in addition shows comparable performance in the patient outcomes in this cohort. CAB is thus an excellent and cost-effective alternative to ODX.",2020,"Compared to the concordance reported for other tests, CAB shows high concordance with ODX, and in addition shows comparable performance in the patient outcomes in this cohort.","['109 early stage breast cancer patients who had previously taken the ODX test were retested with', 'Indian and Caucasian patients']","['CanAssist Breast (CAB', 'CAB', 'breast cancer prognostic tests CanAssist Breast and Oncotype DX']","['Distant metastasis-free survival', 'overall concordance of CAB with ODX']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}]",109.0,0.0244953,"Compared to the concordance reported for other tests, CAB shows high concordance with ODX, and in addition shows comparable performance in the patient outcomes in this cohort.","[{'ForeName': 'Aditya K', 'Initials': 'AK', 'LastName': 'Sengupta', 'Affiliation': 'OncoStem Diagnostics, Bangalore, Karnataka, India.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Gunda', 'Affiliation': 'OncoStem Diagnostics, Bangalore, Karnataka, India.'}, {'ForeName': 'Sukriti', 'Initials': 'S', 'LastName': 'Malpani', 'Affiliation': 'OncoStem Diagnostics, Bangalore, Karnataka, India.'}, {'ForeName': 'Chandra Prakash V', 'Initials': 'CPV', 'LastName': 'Serkad', 'Affiliation': 'OncoStem Diagnostics, Bangalore, Karnataka, India.'}, {'ForeName': 'Chetana', 'Initials': 'C', 'LastName': 'Basavaraj', 'Affiliation': 'OncoStem Diagnostics, Bangalore, Karnataka, India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Bapat', 'Affiliation': 'Virtua Hospital, Voorhees, NJ, USA.'}, {'ForeName': 'Manjiri M', 'Initials': 'MM', 'LastName': 'Bakre', 'Affiliation': 'OncoStem Diagnostics, Bangalore, Karnataka, India.'}]",Cancer medicine,['10.1002/cam4.3495']
3107,33027708,Delivery room skin-to-skin contact in preterm infants affects long-term expression of stress response genes.,"Premature birth is a traumatic event that puts mother and child at risk for subsequent psychopathology. Skin-to-skin contact in the form of intermittent kangaroo mother care has been shown to positively affect the infant's stress response and cognitive development, but underlying mechanisms remain unclear. Moreover, first skin-to-skin contact is usually delayed for days after birth. In the delivery room skin-to-skin study (DR-SSC), a prospective randomized controlled trial conducted from 2/2012 to 7/2015, we set out to assess the effect of delivery room skin-to-skin contact on the infant's mRNA expression of six key molecules involved in stress response and neurobehavioral development at hospital discharge. 88 firstborn, singleton preterm infants (born at 25-32 weeks of gestational age) were included. In the delivery room after initial stabilization, infants were randomized to either 60 min of skin-to-skin or 5 min of visual contact with their mother. In this explorative add-on study on the original DR-SSC study, we determined the expression of six important stress response genes (CRHR1 and CRHR2, AVP, NR3C1, HTR2A, and SLC6A4) in peripheral white blood cells of infants during routine blood sampling upon hospital discharge (corrected gestational age of 40 weeks). Infants were followed up to six months corrected age. Relative mRNA expression of the corticotropin releasing hormone receptor 2 (CRH R2), the glucocorticoid receptor gene (NR3C1), and the serotonin transporter gene (SLC6A4) was significantly reduced in the delivery room SSC infants. Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age. Our results highlight the importance of delivery room mother-child skin-to-skin contact and underline the urgent need for in-depth studies on the underlying molecular mechanisms.",2020,"Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age.","['peripheral white blood cells of infants during routine blood sampling upon hospital discharge (corrected gestational age of 40 weeks', 'preterm infants', '88 firstborn, singleton preterm infants (born at 25-32 weeks of gestational age']","['delivery room skin-to-skin contact', '60 min of skin-to-skin or 5 min of visual contact with their mother']","['HPA axis reactivity and parameters of mother-child interaction', 'expression of six important stress response genes (CRHR1 and CRHR2, AVP, NR3C1, HTR2A, and SLC6A4']","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0011212', 'cui_str': 'Delivery suite'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0078039', 'cui_str': 'VAP combination'}, {'cui': 'C1370369', 'cui_str': 'NR3C1 protein, human'}, {'cui': 'C1456457', 'cui_str': 'SLC6A4 protein, human'}]",,0.0170859,"Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hucklenbruch-Rother', 'Affiliation': ""Metabolism and Perinatal Programming, Children's Hospital, University of Cologne, Cologne, Germany. Electronic address: eva.rother@uni-koeln.de.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Vohlen', 'Affiliation': ""Metabolism and Perinatal Programming, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Mehdiani', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Titus', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Roth', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kribs', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Mehler', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104883']
3108,33027722,Hysteroscopic versus cervical injection for sentinel node detection in endometrial cancer: A multicenter prospective randomised controlled trial from the Multicenter Italian Trials in Ovarian cancer (MITO) study group.,"AIM
During the last years, the role of sentinel lymph node mapping (SLNM) for endometrial cancer (EC) surgical treatment has increased in popularity. However, several controversies remain about different technical steps of SLNM. Thus, a randomised control trial was designed to compare cervical (CI) and hysteroscopic (HI) indocyanine green (ICG) injection for SLNM of newly diagnosed EC undergoing surgical staging. The primary end-point of the study was to compare these two techniques in terms of para-aortic detection rate.
METHODS
Patients with apparent stage I or II histologically confirmed EC undergoing surgery were included in the study. This randomised trial distinguished patients in two study groups according to two different techniques of ICG SLNM: CI versus HI injection. Patients who met the inclusion criteria were randomly assigned to CI or HI injection in a 1:1 ratio. The central randomisation system allocated patient randomisation numbers sequentially in the order in which the patients were enrolled. This randomised trial was not blinded for either patients or the surgeons.
RESULTS
From March 2017 until April 2019, a total of 165 patients were randomised in this study: 85 (51.5%) in the CI group and 80 (48.5%) in the HI group. After randomisation, 14 (8.5%) patients were excluded from the study. Finally, 151 patients were included in the analysis: 82 (54.3%) in the CI group and 69 (45.7%) in the HI group. Hysteroscopy injection shows an ability to detect Sentinel nodes (SNLs) in the para-aortic area of about 10% greater compared with CI injection, although this difference did not reach statistical significance. The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%). The CI injection was correlated with higher SLN detection rates at the pelvic level compared with HI injection. Pelvic and overall detection was higher in the CI group.
CONCLUSIONS
The present study supports the adoption of CI instead of HI injection because the former allows better identification of sentinel nodes (especially in the pelvic area). Detection of SLN in the para-aortic area was slightly higher in patients receiving a HI injection, but the difference with the CI route was not statistically significant.",2020,The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%).,"['151 patients were included in the analysis: 82 (54.3%) in the CI group and 69 (45.7%) in the HI group', '165 patients', 'Patients who met the inclusion criteria', 'patients or the surgeons', 'From March 2017 until April 2019', 'Patients with apparent stage I or II histologically confirmed EC undergoing surgery were included in the study', 'endometrial cancer', 'newly diagnosed EC undergoing surgical staging']","['cervical (CI) and hysteroscopic (HI) indocyanine green (ICG) injection', 'sentinel lymph node mapping (SLNM', 'Hysteroscopic versus cervical injection', 'ICG\xa0SLNM: CI versus HI injection', 'CI or HI injection', 'Hysteroscopy injection']","['para-aortic detection rate', 'SLN detection rates', 'Pelvic and overall detection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443276', 'cui_str': 'Pathological staging'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1519247', 'cui_str': 'Sentinel lymph node mapping'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0442134', 'cui_str': 'Para-aortic'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",165.0,0.181524,The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%).,"[{'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Ditto', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy. Electronic address: antonino.ditto@istitutotumori.mi.it.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Casarin', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Pinelli', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Perrone', 'Affiliation': ""Unit Gynaecologic Oncology, Sant'Orsola Malpighi of Bologna, Bologna, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Scollo', 'Affiliation': 'Unit of Obstetrics and Gynaecology, Cannizzaro Hospital of Catania, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Martinelli', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Bogani', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Leone Roberti Maggiore', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Signorelli', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Chiappa', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Giorda', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS CRO Oncologic Institute of Aviano, Aviano, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Scibilia', 'Affiliation': 'Unit of Obstetrics and Gynaecology, Cannizzaro Hospital of Catania, Italy.'}, {'ForeName': 'Pierandrea', 'Initials': 'P', 'LastName': 'De Iaco', 'Affiliation': ""Unit Gynaecologic Oncology, Sant'Orsola Malpighi of Bologna, Bologna, Italy.""}, {'ForeName': 'Mariateresa', 'Initials': 'M', 'LastName': 'Evangelista', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ghezzi', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Biagio', 'Initials': 'B', 'LastName': 'Paolini', 'Affiliation': 'Department of Pathology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Lo Vullo', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy; Unit of Clinical Epidemiology and Trial Organization, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy; Unit of Clinical Epidemiology and Trial Organization, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Montone', 'Affiliation': 'Clinical Study Coordinator, Ufficio Operativo per la Ricerca Clinica - Clinical Trial Center Fondazione IRCCS Istituto Nazionale dei Tumori, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Raspagliesi', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.030']
3109,33028243,BMC family practice integrated GP care for patients with persistent physical symptoms: feasibility cluster randomised trial.,"BACKGROUND
Patients continue to suffer from medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS). General practitioners (GPs) play a key role in the management of PPS and require further training. Patients are often frustrated with the care they receive. This study aims to assess the acceptability of an 'integrated GP care' approach which consists of offering self-help materials to patients with PPS and offering their GPs training on how to utilise cognitive behavioural skills within their consultations, as well as assessing the feasibility of conducting a future trial in primary care to evaluate its benefit.
METHODS
A feasibility cluster randomised controlled trial was conducted in primary care, South London, UK. GP practices (clusters) were randomly allocated to 'integrated GP care plus treatment as usual' or 'treatment as usual'. Patients with PPS were recruited from participating GP practices before randomisation. Feasibility parameters, process variables and potential outcome measures were collected at pre-randomisation and at 12- and 24-weeks post-randomisation at cluster and individual participant level.
RESULTS
Two thousand nine hundred seventy-eight patients were identified from 18 GP practices. Out of the 424 patients who responded with interest in the study, 164 fully met the eligibility criteria. One hundred sixty-one patients provided baseline data before cluster randomisation and therefore were able to participate in the study. Most feasibility parameters indicated that the intervention was acceptable and a future trial feasible. 50 GPs from 8 GP practices (randomised to intervention) attended the offer of training and provided positive feedback. Scores in GP knowledge and confidence increased post-training. Follow-up rate of patients at 24 weeks was 87%. However estimated effect sizes on potential clinical outcomes were small.
CONCLUSIONS
It was feasible to identify and recruit patients with PPS. Retention rates of participants up to 24 weeks were high. A wide range of health services were used. The intervention was relatively low cost and low risk. This complex intervention should be further developed to improve patients'/GPs' utilisation of audio/visual and training resources before proceeding to a full trial evaluation.
TRIAL REGISTRATION
NCT02444520 (ClinicalTrials.gov).",2020,Scores in GP knowledge and confidence increased post-training.,"['GP practices (clusters', 'Two thousand nine hundred seventy-eight patients were identified from 18 GP practices', '424 patients who responded with interest in the study, 164 fully met the eligibility criteria', 'Patients with PPS were recruited from participating GP practices before randomisation', 'patients with persistent physical symptoms', 'Patients continue to suffer from medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS', 'One hundred sixty-one patients provided baseline data before cluster randomisation and therefore were able to participate in the study', 'primary care, South London, UK']","['BMC family practice integrated GP care', ""integrated GP care plus treatment as usual' or 'treatment as usual"", 'GPs training']",['Retention rates'],"[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",2978.0,0.121128,Scores in GP knowledge and confidence increased post-training.,"[{'ForeName': 'Meenal', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'James', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neurosciences, Psychology and Neuroscience King's College, London, UK.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine King's College London, London, UK.""}, {'ForeName': 'Mujtaba', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'UK South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hotopf', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'David', 'Affiliation': 'Division of Psychiatry, Maple House, UCL Institute of Mental Health, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': 'Institute for Lifecourse Development, University of Greenwich, Old Royal Naval College, Park Row, Greenwich, London, SE10 9LS, UK.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neurosciences, Psychology and Neuroscience King's College, London, UK.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK. trudie.chalder@kcl.ac.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC family practice,['10.1186/s12875-020-01269-9']
3110,33031181,Termination of the ESH-CHL-SHOT trial.,,2020,,[],[],[],[],[],[],,0.0651366,,"[{'ForeName': 'Lisheng', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'FuWai Hospital and Cardiovascular Institute.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': 'Università Milano-Bicocca, Milan.'}]",Journal of hypertension,['10.1097/HJH.0000000000002660']
3111,33031860,Believing is achieving - On the role of treatment expectation in neurofeedback applications.,"In neurofeedback applications, neural activity is recorded, processed in real-time and fed back to the user in order to facilitate self-regulation of the putative neural mechanisms that underlie cognition and behavior. Numerous studies suggest that neurofeedback interventions are an efficacious treatment particularly for patients with attention-deficit/hyperactivity disorder (ADHD). In recent years, however, findings of several well-controlled studies raised doubts concerning the proposed mechanism of action behind the behavioral effect of neurofeedback. This study investigated the impact of expectation on the efficacy of a sensorimotor rhythm (SMR) training. In a within-subjects design 30 blinded volunteers with ADHD symptoms received a standard SMR training session after inducing no (no-expectancy condition), positive (placebo condition), and negative (nocebo condition) expectations regarding the effectiveness of neurofeedback (by telling them that they would train a specific frequency band that was previously shown to be either unrelated to attention, should improve attention, or interfere with attentional processes). After each training, participants were presented with a cognitive test and subsequently requested to rate their performance on it. We could show that participants were able to successfully modify their EEG signal during training. Further, we found an effect over trainings on objective attentional performance. Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence. This study presents strong first evidence for a substantial effect of self-confirming response expectancies as one factor underlying the efficacy of neurofeedback. Future research has to carefully consider the impact of such psychosocial mechanisms when evaluating the (specific) efficacy of neuromodulatory treatments.",2020,"Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence.",['patients with attention-deficit/hyperactivity disorder (ADHD'],"['standard SMR training session after inducing no (no-expectancy condition), positive (placebo condition), and negative (nocebo condition) expectations', 'sensorimotor rhythm (SMR) training', 'neurofeedback interventions']",['objective attentional performance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}]",30.0,0.0296425,"Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schönenberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Germany. Electronic address: michael.schoenenberg@uni-tuebingen.de.'}, {'ForeName': 'Anna-Lena', 'Initials': 'AL', 'LastName': 'Weingärtner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weimer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scheeff', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Germany.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110129']
3112,33032009,Step-stress vs. staircase fatigue tests to evaluate the effect of intaglio adjustment on the fatigue behavior of simplified lithium disilicate glass-ceramic restorations.,"The aim of the study was to compare the outcomes for the fatigue mechanical behavior of bonded simplified lithium disilicate restorations, with and without an internal adjustment by grinding with diamond bur in running two fatigue tests: Staircase and Step-stress testing approaches. Ceramic discs (IPS e.max CAD) were prepared (Ø = 10 mm; thickness = 1.0 mm), submitted to an in-lab simulation of CAD/CAM milling (#60 SiC paper) and allocated into 2 groups according to the internal adjustment by grinding of the cementation surface: no adjustment (CTRL); or grinding with a coarse diamond bur (GR). Adhesive cementation (Multilink N) was performed onto epoxy resin discs (Ø = 10 mm; thickness = 2 mm) after ceramic/epoxy surface treatments. The cemented assemblies of each group were randomly assigned into 2 subgroups considering two fatigue tests (n = 15): Staircase - SC (250,000 cycles; 20 Hz), or Step-stress - SS (10,000 cycles per step; 20 Hz). Roughness, topographic and fractographic analyses were additionally performed. Statistical analyses were carried out using the Dixon and Mood method for Staircase data, and Kaplan-Meier and Mantel-Cox (log-rank) tests for Step-stress data. Ceramic restorations having its intaglio surface ground (GR group: SC test = 306.67 N; SS test = 646.67 N) presented lower fatigue failure load (FFL) values than the CTRL group (SC test = 879.28 N; SS test = 1090.00 N), regardless of the fatigue testing approach. The percentage of mean FFL decrease comparing the CTRL to GR group was higher for SC (65.1%) than the SS (40.7%) approach. However, a different total number of cycles was applied for each method. Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior. Therefore, both methods can be applied for similar evaluations (fatigue testing for ceramic restorations).",2020,Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior.,[],"['Staircase - SC (250,000 cycles; 20\xa0Hz), or Step-stress - SS', 'Adhesive cementation (Multilink N', 'internal adjustment by grinding of the cementation surface: no adjustment (CTRL); or grinding with a coarse diamond bur (GR', 'Ceramic discs (IPS e.max CAD']","['percentage of mean FFL decrease', 'Roughness, topographic and fractographic analyses', 'fatigue failure load (FFL) values']",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0007656', 'cui_str': 'Cementation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205194', 'cui_str': 'Coarse'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0283014,Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior.,"[{'ForeName': 'Andressa Borin', 'Initials': 'AB', 'LastName': 'Venturini', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: andressa.venturini@hotmail.com.'}, {'ForeName': 'Thaís Camponogara', 'Initials': 'TC', 'LastName': 'Bohrer', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: thaiscbohrer@hotmail.com.'}, {'ForeName': 'Patrícia Eliana', 'Initials': 'PE', 'LastName': 'Fontana', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: patricia_fontana_@hotmail.com.'}, {'ForeName': 'Tatiana Tambara', 'Initials': 'TT', 'LastName': 'Fröhlich', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: frohlichtatiana@gmail.com.'}, {'ForeName': 'Liliana Gressler', 'Initials': 'LG', 'LastName': 'May', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: liligmay@gmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.104091']
3113,33037036,Further improvement in glycemic control after switching from exenatide two times per day to exenatide once-weekly autoinjected suspension in patients with type 2 diabetes: 52-week results from the DURATION-NEO-1 study.,"INTRODUCTION
Investigate the effects of switching from two times per day exenatide to once-weekly exenatide administered by autoinjector (exenatide once-weekly suspension by autoinjector (QWS-AI)) or treatment with exenatide QWS-AI for 1 year.
RESEARCH DESIGN AND METHODS
In this phase III open-label study, adults with type 2 diabetes were randomized to receive exenatide QWS-AI (2 mg) or exenatide two times per day (5 mcg for 4 weeks, followed by 10 mcg) for 28 weeks. During a subsequent non-randomized 24-week extension, patients who received exenatide two times per day were switched to exenatide QWS-AI and those randomized to exenatide QWS-AI continued this treatment. Efficacy measures included changes from baseline in glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight.
RESULTS
In total, 315 patients (mean baseline A1C of 8.5%) completed the initial 28 weeks of randomized treatment with exenatide QWS-AI (n=197) or exenatide two times per day (n=118) and were included in the 24-week extension (mean A1C of 7.0% and 7.3%, respectively, at week 28). From weeks 28-52, patients who switched from exenatide two times per day to exenatide QWS-AI had additional A1C reductions of approximately 0.5% (mean A1C change from baseline of -1.4% at week 52) and further reductions from baseline in FPG. Patients who continued exenatide QWS-AI treatment for 52 weeks showed clinically relevant A1C reductions (mean A1C change from baseline of -1.3% at week 52). Body-weight reductions achieved through week 28 were sustained at week 52 in both groups. There were no unexpected safety concerns or changes in the safety profile among patients who switched from exenatide two times per day to exenatide QWS-AI or those who continued exenatide QWS-AI treatment for 52 weeks.
CONCLUSIONS
Switching from exenatide two times per day to exenatide QWS-AI resulted in further A1C reductions and maintenance of earlier decreases in body weight, while continued therapy with exenatide QWS-AI for 52 weeks maintained A1C and body-weight reductions, without additional safety or tolerability concerns.
TRIAL REGISTRATION NUMBER
NCT01652716.",2020,"Efficacy measures included changes from baseline in glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight.
","['adults with type 2 diabetes', 'patients with type 2 diabetes', '315 patients (mean baseline A1C of 8.5%) completed the initial 28 weeks of randomized treatment with']","['exenatide QWS-AI (n=197) or exenatide', 'exenatide', 'exenatide administered by autoinjector (exenatide once-weekly suspension by autoinjector (QWS-AI)) or treatment with exenatide QWS-AI', 'exenatide QWS-AI', 'exenatide QWS-AI (2\u2009mg) or exenatide']","['clinically relevant A1C reductions', 'glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight', 'Body-weight reductions', 'glycemic control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",315.0,0.0159734,"Efficacy measures included changes from baseline in glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight.
","[{'ForeName': 'Carol H', 'Initials': 'CH', 'LastName': 'Wysham', 'Affiliation': 'Section of Endocrinology and Metabolism, MultiCare Rockwood Clinic, Spokane, Washington, USA cwysham@multicare.org.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, Texas, USA.'}, {'ForeName': 'Marion L', 'Initials': 'ML', 'LastName': 'Vetter', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hardy', 'Affiliation': 'Late clinical development, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'Clinical, Diabetes, Metabolism and GI, AstraZeneca, Gaithersburg, Maryland, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000773']
3114,33037080,Baricitinib-associated changes in global gene expression during a 24-week phase II clinical systemic lupus erythematosus trial implicates a mechanism of action through multiple immune-related pathways.,"OBJECTIVE
To characterise the molecular pathways impacted by the pharmacologic effects of the Janus kinase (JAK) 1 and JAK2 inhibitor baricitinib in SLE.
METHODS
In a phase II, 24-week, randomised, placebo-controlled, double-blind study (JAHH), RNA was isolated from whole blood in 274 patients and analysed using Affymetrix HTA2.0 array. Serum cytokines were measured using ultrasensitive quantitative assays.
RESULTS
Gene expression profiling demonstrated an elevation of STAT1 , STAT2 and multiple interferon (IFN) responsive genes at baseline in patients with SLE. Statistical and gene network analyses demonstrated that baricitinib treatment reduced the mRNA expression of functionally interconnected genes involved in SLE including STAT1 -target, STAT2 -target and STAT4- target genes and multiple IFN responsive genes. At baseline, serum cytokines IFN-α, IFN-γ, interleukin (IL)-12p40 and IL-6 were measurable and elevated above healthy controls. Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.
CONCLUSION
Baricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis. Baricitinib consistently reduced serum levels of two key cytokines implicated in SLE pathogenesis, IL-12p40 and IL-6.",2020,"Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.
CONCLUSION
Baricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis.",['274 patients and analysed using Affymetrix HTA2.0 array'],"['target and STAT4', 'placebo']","['Serum cytokines', 'serum IL-12p40 and IL-6 cytokine levels', 'elevation of STAT1 , STAT2 and multiple interferon (IFN) responsive genes', 'mRNA expression', 'serum cytokines IFN-α, IFN-γ, interleukin (IL)-12p40 and IL-6', 'global gene expression', 'RNA expression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0255034', 'cui_str': 'STAT4 Protein'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C1099914', 'cui_str': 'IL12B protein, human'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1432814', 'cui_str': 'STAT1 protein, human'}, {'cui': 'C0295166', 'cui_str': 'Transcription Factor STAT2'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}]",274.0,0.116982,"Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.
CONCLUSION
Baricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dörner', 'Affiliation': 'DRFZ Berlin and Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany thomas.doerner@charite.de.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational & Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Petri', 'Affiliation': 'Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Wallace', 'Affiliation': 'Department of Rheumatology, Cedars-Sinai Medical Center, West Hollywood, California, USA.'}, {'ForeName': 'Ernst R', 'Initials': 'ER', 'LastName': 'Dow', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Higgs', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Rocha', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Crowe', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Benschop', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Byers', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Silk', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'de Bono', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Fantini', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Hoffman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}]",Lupus science & medicine,['10.1136/lupus-2020-000424']
3115,33035741,"Differentiating ""types"" of treatment dropout: Nonstarters in an RCT of prolonged exposure versus sertraline.","Despite effective interventions for posttraumatic stress disorder (PTSD), many patients prematurely drop out. Differentiating ""types"" of dropout at various stages of treatment may improve our ability to predict and prevent attrition. Using data from a doubly randomized preference trial, this study examined patient dropout prior to treatment and compared these ""nonstarters"" with treatment starters and in-treatment dropouts. Patients (N = 200) with chronic PTSD were randomized to ""choice"" (prolonged exposure [PE] or sertraline) or ""no choice"" (re-randomized to PE or sertraline) and received up to 10 weeks of treatment. Overall dropout rate was 33.0% (n = 66). A substantial minority were nonstarters (n = 19; 28.8%). Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001). These differences remained even when comparing nonstarters to patients that began treatment but eventually dropped out. Differences in beliefs (i.e., perceived credibility) toward one treatment versus the other were also linked to pretreatment dropout. Reasons underlying dropout likely differ during various treatment stages. Better understanding risk factors for types of dropout may inform strategies to boost engagement and retention, ultimately improving patient outcomes.",2020,"Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001).",['Patients (N\xa0=\xa0200) with chronic PTSD'],"['choice"" (prolonged exposure [PE] or sertraline) or ""no choice"" (re-randomized to PE or sertraline', 'sertraline']","['Overall dropout rate', 'severe PTSD symptomatology']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}]","[{'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]",200.0,0.0323563,"Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001).","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Kline', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA. Electronic address: ack63@case.edu.'}, {'ForeName': 'Allison L', 'Initials': 'AL', 'LastName': 'Baier', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Klein', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Norah C', 'Initials': 'NC', 'LastName': 'Feeny', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Zoellner', 'Affiliation': 'Center for Anxiety and Traumatic Stress, University of Washington, Department of Psychology, Guthrie Hall, Box 351525, Seattle, WA, 98195-1525, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103750']
3116,33035763,Effect of oral health intervention on cognitive decline in community-dwelling older adults: A randomized controlled trial.,"PURPOSE
The incidence of dementia is rapidly increasing worldwide, especially in developed countries. Little is known regarding the effectiveness of dental intervention to prevent dementia or a decline in cognitive functions among community-dwelling older adults, but a few studies have reported a correlation between the lack of regular dental checkups and dementia. For that reason, this study aimed to investigate the effects of oral health intervention on cognitive functions in community-dwelling subjects with a mild cognitive decline via a randomized controlled trial.
PATIENTS AND METHODS
Fifty-five community-dwelling older adults with a Mini-Mental State Examination score of ≥21 to ≤26 who had not visited a dental clinic in the previous year were randomized to an intervention group (n = 28) or a control group (n = 29). The intervention group received monthly oral health intervention by dental hygienists for 8 months while the control group did not. Data on demographics, cognitive function and oral parameters were collected before and after the intervention.
RESULTS
Twenty-five subjects in the intervention group (mean age 77.0 years) and 25 in the control group (mean age 72.8 years) completed the study. Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05). There were also significant interactions between the TMT-A and TMT-B scores, oral diadochokinesis, tongue pressure and chewing ability (P < 0.05).
CONCLUSION
Oral health intervention by dental hygienists may be effective for improving the oral health and executive function of cognitive function assessed via TMT.",2020,"Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05).","['Twenty-five subjects in the intervention group (mean age 77.0 years) and 25 in the control group (mean age 72.8 years) completed the study', 'community-dwelling subjects with a mild cognitive decline via a randomized controlled trial', 'community-dwelling older adults', 'Fifty-five community-dwelling older adults with a Mini-Mental State Examination score of ≥21 to ≤26 who had not visited a dental clinic in the previous year']","['oral health intervention', 'monthly oral health intervention']","['cognitive decline', 'Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability', 'cognitive functions', 'demographics, cognitive function and oral parameters', 'TMT-A and TMT-B scores, oral diadochokinesis, tongue pressure and chewing ability']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0011344', 'cui_str': 'Dental clinic'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0278157', 'cui_str': 'Diadochokinesia'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0566339', 'cui_str': 'Ability to chew'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",55.0,0.0438053,"Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05).","[{'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Matsubara', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan. Electronic address: m.chiakingyo@gmail.com.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Shirobe', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan; Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: mashirobe@gmail.com.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Furuya', 'Affiliation': 'Department of Geriatric Dentistry, Showa University School of Dentistry, 2-1-1 Kitasenzoku, Ohta-ku, Tokyo 145-8515, Japan. Electronic address: furuyajunichi@gmail.com.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan; Gerodontology, Department of Oral Health Science, Faculty of Dental Medicine, Hokkaido University, Nishi-7, Kita-13, Kita-ku, Sapporo, 060-8586, Japan. Electronic address: ywata@den.hokudai.ac.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Motokawa', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: kikiki_1004@yahoo.co.jp.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Edahiro', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: aedahiro514@gmail.com.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Ohara', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: yohara@tmig.or.jp.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Awata', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: awata@tmig.or.jp.'}, {'ForeName': 'Hunkyung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: kimhk@tmig.or.jp.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: fujiwayo@tmig.or.jp.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Obuchi', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: obuchipc@tmig.or.jp.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Hirano', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: h-hiro@gd5.so-net.ne.jp.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Minakuchi', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan. Electronic address: s.minakuchi.gerd@tmd.ac.jp.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104267']
3117,33036155,"Effects of the Daily Consumption of Stevia on Glucose Homeostasis, Body Weight, and Energy Intake: A Randomised Open-Label 12-Week Trial in Healthy Adults.","Stevia is a non-nutritive sweetener, providing sweet taste with no calories. This randomised, controlled, open-label 2-parallel arm trial examined the effects of daily stevia consumption on glycaemia in healthy adults. Secondary endpoints included body weight (BW) and energy intake (EI). Healthy participants ( n = 28; aged 25 ± 5y, body mass index 21.2 ± 1.7 kg/m 2 ) were randomised into either the stevia group ( n = 14)-required to consume a stevia extract daily-or to the control group ( n = 14). At weeks 0 and 12, the glucose and insulin responses to an oral glucose tolerance test were measured; BW and EI were assessed at weeks 0, 6, and 12. There was no significant difference in the glucose or insulin responses. There was a significant main effect of group on BW change (F(1,26) = 5.56, p = 0.026), as the stevia group maintained their weight as opposed to the control group (mean weight change at week 12: -0.22 kg, 95%CI [-0.96, 0.51] stevia group, +0.89 kg, 95%CI [0.16, 1.63] control group). The energy intake was significantly decreased between week 0 and 12 in the stevia group ( p = 0.003), however no change was found in the control group ( p = 0.973). Although not placebo-controlled, these results suggest that daily stevia consumption does not affect glycaemia in healthy individuals, but could aid in weight maintenance and the moderation of EI.",2020,"The energy intake was significantly decreased between week 0 and 12 in the stevia group ( p = 0.003), however no change was found in the control group ( p = 0.973).","['Healthy Adults', 'healthy individuals', 'healthy adults', 'Healthy participants ( n = 28; aged 25 ± 5y, body mass index 21.2 ± 1.7 kg/m 2 ']","['stevia group ( n = 14)-required to consume a stevia extract daily-or to the control group', 'placebo', 'daily stevia consumption']","['body weight (BW) and energy intake (EI', 'energy intake', 'Glucose Homeostasis, Body Weight, and Energy Intake', 'glucose or insulin responses', 'glucose and insulin responses to an oral glucose tolerance test']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517512', 'cui_str': '1.7'}]","[{'cui': 'C0075246', 'cui_str': 'stevioside'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",28.0,0.0416548,"The energy intake was significantly decreased between week 0 and 12 in the stevia group ( p = 0.003), however no change was found in the control group ( p = 0.973).","[{'ForeName': 'Nikoleta S', 'Initials': 'NS', 'LastName': 'Stamataki', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Crooks', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}, {'ForeName': 'Abubaker', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'McLaughlin', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}]",Nutrients,['10.3390/nu12103049']
3118,33039382,Early changes in appetite and energy expenditure are not associated to body weight and fat losses in pre-menopausal women living with overweight/obesity.,"BACKGROUND
The aim of the study was to investigate whether early changes (1-week) in energy balance-related measures would predict changes in body weight (BW) and fat losses in women living with overweight/obesity.
METHODS
BW, body composition (DXA), resting energy expenditure (REE)(indirect calorimetry), olfactory performance (Sniffin' Sticks), appetite and palatability (visual analogue scale) were measured at baseline, after a 1-week of caloric restriction as well as post-intervention (at 10 and 20 weeks) in a group of 30 women living with overweight/obesity.
RESULTS
A significant decrease in REE (p = 0.033) was noted after 1 week. Fasting desire to eat (p = 0.004), hunger (p = 0.001) and prospective food consumption (p = 0.001) all increased after 1 week. Similarly, significant increases in AUC SQ for desire to eat (p = 0.01), hunger (p = 0.005) and prospective food consumption (p = 0.001) were noted after 1 week. However, these early changes were not associated to final BW or FM losses at the end of the weight loss intervention.
CONCLUSION
Despite significant changes in REE and appetite soon after the onset of a BW loss intervention, these early changes do not seem to predict final BW or FM losses at the end of the program in women living with overweight/obesity.",2020,"Similarly, significant increases in AUC SQ for desire to eat (p = 0.01), hunger (p = 0.005) and prospective food consumption (p = 0.001) were noted after 1 week.","['pre-menopausal women living with overweight/obesity', '30 women living with overweight/obesity', 'women living with overweight/obesity']",[],"['appetite and energy expenditure', 'Fasting desire to eat', 'body weight (BW) and fat losses', 'prospective food consumption', 'final BW or FM losses', 'REE and appetite', 'hunger', ""body composition (DXA), resting energy expenditure (REE)(indirect calorimetry), olfactory performance (Sniffin' Sticks), appetite and palatability (visual analogue scale"", 'body weight and fat losses', 'REE', 'AUC SQ for desire to eat']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0006779', 'cui_str': 'Calorimetry'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",30.0,0.0260886,"Similarly, significant increases in AUC SQ for desire to eat (p = 0.01), hunger (p = 0.005) and prospective food consumption (p = 0.001) were noted after 1 week.","[{'ForeName': 'Luzia Jaeger', 'Initials': 'LJ', 'LastName': 'Hintze', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Goldfield', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, K1H 8L1, Canada.""}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Séguin', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada; Ryan Séguin is deceased.'}, {'ForeName': 'Aleck', 'Initials': 'A', 'LastName': 'Damphousse', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Riopel', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Doucet', 'Affiliation': 'Behavioural Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, K1N 6N5, Canada. Electronic address: edoucet@uottawa.ca.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113201']
3119,33027506,Economic threat heightens conflict detection: sLORETA evidence.,"Economic threat has far-reaching emotional and social consequences, yet the impact of economic threat on neurocognitive processes has received little empirical scrutiny. Here, we examined the causal relationship between economic threat and conflict detection, a critical process in cognitive control associated with the anterior cingulate cortex (ACC). Participants (N = 103) were first randomly assigned to read about a gloomy economic forecast (Economic Threat condition) or a stable economic forecast (No-Threat Control condition). Notably, these forecasts were based on real, publicly available economic predictions. Participants then completed a passive auditory oddball task composed of frequent standard tones and infrequent, aversive white-noise bursts, a task that elicits the N2, an event-related potential component linked to conflict detection. Results revealed that participants in the Economic Threat condition evidenced increased activation source localized to the ACC during the N2 to white-noise stimuli. Further, ACC activation to conflict mediated an effect of Economic Threat on increased justification for personal wealth. Economic threat thus has implications for basic neurocognitive function. Discussion centers on how effects on conflict detection could shed light on the broader emotional and social consequences of economic threat.",2020,Results revealed that participants in the Economic Threat condition evidenced increased activation source localized to the ACC during the N2 to white-noise stimuli.,['Participants (N = 103'],"['passive auditory oddball task comprised of frequent standard tones and infrequent, aversive white-noise bursts, a task that elicits the N2, an event-related potential (ERP) component linked to conflict detection', 'read about a gloomy economic forecast (Economic Threat condition) or a stable economic forecast (No-Threat Control condition']",[],"[{'cui': 'C4517526', 'cui_str': '103'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],103.0,0.0127463,Results revealed that participants in the Economic Threat condition evidenced increased activation source localized to the ACC during the N2 to white-noise stimuli.,"[{'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Nash', 'Affiliation': 'Department of Psychology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Tran', 'Affiliation': 'Department of Psychology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Leota', 'Affiliation': 'Department of Psychology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Scott', 'Affiliation': 'Department of Psychology, University of Alberta, Edmonton, Canada.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsaa139']
3120,33028223,Improving stamina and mobility with preop walking in surgical patients with frailty traits -OASIS IV: randomized clinical trial study protocol.,"BACKGROUND
Frail older surgical patients face more than a two-fold increase in postoperative complications, including myocardial infarction, deep vein thrombosis, pulmonary embolism, pneumonia, ileus, and others. Many of these complications occur because of postoperative loss of stamina and poor mobility. Preoperative exercise may better prepare these vulnerable patients for surgery. We present the protocol for our ongoing randomized trial to assess the impact of a preoperative walking intervention with remote coaching and pedometer on outcomes of stamina (six-minute walk distance- 6MWD) and mobility (postoperative steps) in older adults with frailty traits.
METHODS
We will be conducting a randomized clinical trial with a total of 120 patients permitting up to a 33% rate of attrition, to reach a final sample size of 80 (with 40 patients for each study arm). We will include patients who are age 60 or higher, score 4 or greater on the Edmonton Frailty Scale assessment, and will be undergoing a surgical operation that requires a 2 or more night hospital stay to be eligible for our trial. Using block randomization stratified on baseline 6MWD, we will assign patients to wear a pedometer. At the end of three baseline days, an athletic trainer (AT) will provide a daily step count goal reflecting a 10-20% increase from baseline. Subsequently, the AT will call weekly to further titrate the goal or calls more frequently if the patient is not meeting the prescribed goal. Controls will receive general walking advice. Our main outcome is change in 6MWD on postoperative day (POD) 2/3 vs. baseline. We will also collect 6MWD approximately 4 weeks after surgery and daily in-hospital steps.
CONCLUSION
If changes in a 6MWD and step counts are significantly higher for the intervention group, we believe this will confirm our hypothesis that the intervention leads to decreased loss of stamina and mobility. Once confirmed, we anticipate expanding to multiple centers to assess the interventional impact on clinical endpoints.
TRIAL REGISTRATION
The randomized clinical trial was registered on clinicaltrials.gov under the identifier NCT03892187 on March 27, 2019.",2020,"We will include patients who are age 60 or higher, score 4 or greater on the Edmonton Frailty Scale assessment, and will be undergoing a surgical operation that requires a 2 or more night hospital stay to be eligible for our trial.","['surgical patients with frailty traits -OASIS', '120 patients permitting up to a 33% rate of attrition, to reach a final sample size of 80 (with 40 patients for each study arm', 'Frail older surgical patients', 'patients who are age 60 or higher, score 4 or greater on the Edmonton Frailty Scale assessment, and will be undergoing a surgical operation that requires a 2 or more night hospital stay to be eligible for our trial', 'older adults with frailty traits']","['Preoperative exercise', 'preoperative walking intervention with remote coaching and pedometer on outcomes of stamina (six-minute walk distance', 'athletic trainer (AT']","['postoperative complications, including myocardial infarction, deep vein thrombosis, pulmonary embolism, pneumonia, ileus', '6MWD) and mobility (postoperative steps', 'loss of stamina and mobility']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0766345', 'cui_str': 'OASIS'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",120.0,0.251973,"We will include patients who are age 60 or higher, score 4 or greater on the Edmonton Frailty Scale assessment, and will be undergoing a surgical operation that requires a 2 or more night hospital stay to be eligible for our trial.","[{'ForeName': 'Laboni', 'Initials': 'L', 'LastName': 'Hoque', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Dewolf', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meyers', 'Affiliation': 'University of Massachusetts Memorial Health Care, Worcester, MA, USA.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'White', 'Affiliation': 'University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mazor', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Stefan', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Crawford', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Alavi', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Yates', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Maxfield', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Feiran', 'Initials': 'F', 'LastName': 'Lou', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Uy', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Walz', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA. alok.kapoor@umassmemorial.org.'}]",BMC geriatrics,['10.1186/s12877-020-01799-y']
3121,33032532,A physical activity program versus usual care in the management of quality of life for pre-frail older adults with chronic pain: randomized controlled trial.,"BACKGROUND
Exercise has shown being effective for managing chronic pain and preventing frailty status in older adults but the effect of an exercise program in the quality of life of pre-frail older adults with chronic pain remains unclear. Our objective was to evaluate the effectiveness of multicomponent structured physical exercise program for pre-frail adults aged 65 years or more with chronic pain to improve their perceived health related quality of life, compared with usual care.
METHODS
Open label randomized controlled trial. Participants were community-dwelling pre-frail older adults aged 65 years or older with chronic pain and non-dependent for basic activities of daily living attending a Primary Healthcare Centre. Forty-four participants were randomly allocated to a control group (n = 20) that received usual care or an intervention group (n = 24) that received an 8-week physical activity and education program. Frailty status (SHARE Frailty Index), quality of life (EuroQol-5D-5L), pain intensity (Visual Analogue Scale), physical performance (Short Physical Performance Battery) and depression (Yessavage) were assessed at baseline, after the intervention and after 3 months follow-up. The effect of the intervention was analysed by mean differences between the intervention and control groups.
RESULTS
The follow-up period (3 months) was completed by 32 patients (73%), 17 in the control group and 15 in the intervention group. Most participants were women (78.1%) with a mean age (standard deviation) of 77.2 (5.9) years and a mean pain intensity of 48.1 (24.4) mm. No relevant differences were found between groups at baseline. After the intervention, mean differences in the EuroQol Index Value between control and intervention groups were significant (- 0.19 95% CI(- 0.33- -0.04)) and remained after 3 months follow-up (- 0.21 95% CI(- 0.37- -0.05)). Participants in the exercise group showed better results in pain intensity and frailty after the intervention, and an improvement in physical performance after the intervention and after 3 months.
CONCLUSIONS
An eight-week physical activity and education program for pre-frail older adults with chronic pain, compared with usual care, could be effective to improve quality of life after the intervention and after three-months follow-up.
STUDY REGISTRATION DETAILS
This study was retrospectively registered in ClinicalTrials.gov with the identifier NCT04045535 .",2020,"Participants in the exercise group showed better results in pain intensity and frailty after the intervention, and an improvement in physical performance after the intervention and after 3 months.
","['older adults', 'Most participants were women (78.1%) with a mean age (standard deviation) of 77.2 (5.9) years and a mean pain intensity of 48.1 (24.4) mm', 'pre-frail adults aged 65\u2009years or more with chronic pain', 'Participants were community-dwelling pre-frail older adults aged 65\u2009years or older with chronic pain and non-dependent for basic activities of daily living attending a Primary Healthcare Centre', 'Forty-four participants', 'pre-frail older adults with chronic pain']","['control group (n\u2009=\u200920) that received usual care or an intervention group (n\u2009=\u200924) that received an 8-week physical activity and education program', 'multicomponent structured physical exercise program', 'physical activity program versus usual care', 'exercise program']","['EuroQol Index Value', 'Frailty status (SHARE Frailty Index), quality of life (EuroQol-5D-5L), pain intensity (Visual Analogue Scale), physical performance (Short Physical Performance Battery) and depression (Yessavage', 'pain intensity and frailty', 'physical performance', 'quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",44.0,0.128245,"Participants in the exercise group showed better results in pain intensity and frailty after the intervention, and an improvement in physical performance after the intervention and after 3 months.
","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Otones', 'Affiliation': 'San Andrés Primary Care Center, Gerencia Asistencial de Atención Primaria, Alberto Palacios, 22, 28021, Madrid, Spain. pedro.otones@salud.madrid.org.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'García', 'Affiliation': 'Nursing Department, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Sanz', 'Affiliation': 'Research Unit, Gerencia Asistencial de Atención Primaria, Madrid, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'Pedraz', 'Affiliation': 'Nursing Department, Universidad Autónoma de Madrid, Madrid, Spain.'}]",BMC geriatrics,['10.1186/s12877-020-01805-3']
3122,33031670,Is a Trial of Perioperative Cognitive Training to Prevent Early Postoperative Cognitive Decline Actually Feasible?,,2020,,[],['Perioperative Cognitive Training'],['Early Postoperative Cognitive Decline'],[],"[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]",,0.0276795,,"[{'ForeName': 'Hilary P', 'Initials': 'HP', 'LastName': 'Grocott', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, University of Manitoba, Winnipeg, Manitoba, Canada, hgrocott@sbgh.mb.ca Department of Anesthesiology, Pharmacology & Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Stephan K W', 'Initials': 'SKW', 'LastName': 'Schwarz', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004859']
3123,31453722,"The Association between Prehospital Vulnerability, ARDS Development, and Mortality among At-Risk Adults. Results from the LIPS-A Clinical Trial.","Rationale: No previous studies have examined the role of prehospital vulnerability in acute respiratory distress syndrome (ARDS) development and mortality in an acutely ill adult population. Objectives: To describe the association between prehospital vulnerability and 1 ) the development of ARDS, 2 ) 28-day mortality, and 3 ) 1-year mortality. Methods: This was a longitudinal prospective cohort study nested within the multicenter LIPS-A (Lung Injury Prevention Study-Aspirin) trial. We analyzed 301 participants who completed Vulnerable Elders Survey (VES) at baseline. Multivariable logistic regression and Cox regression analyses were used to describe the association between vulnerability and short-term outcomes (ARDS and 28-day mortality) and long-term outcomes (1-year mortality), respectively. Results: The VES score ranged from 0 to 10 (median [interquartile range], 2.0 [0-6]); 143 (47.5%) fit criteria for prehospital vulnerability (VES ≥ 3). Vulnerability was not significantly associated with ARDS development (10 [7.0%] vulnerable patients developed ARDS as per LIPS-A study criteria vs. 20 [12.7%] without vulnerability; P = 0.10; adjusted odds ratio [95% confidence interval (CI)], 0.54 [0.24-1.24]; P = 0.15). Nor was vulnerability associated with 28-day mortality (15 [10.5%] vulnerable patients were dead by Day 28 vs. 11 [7.0%] nonvulnerable patients; P = 0.28; adjusted odds ratio [95% CI], 0.95 [0.39-2.26]; P = 0.90). Vulnerability was significantly associated with 1-year mortality in hospital survivors (35 [26.9%] vs. 13 [9.3%]; adjusted hazard ratio [95% CI], 2.20 [1.10-4.37]; P = 0.02). Conclusions: In a population of adults recruited for their high risk of ARDS, prehospital vulnerability, measured by VES, was highly prevalent and strongly associated with 1-year mortality.",2019,"Vulnerability was significantly associated with 1-year mortality in hospital survivors (35 [26.9%] vs. 13 [9.3%]; adjusted hazard ratio [95% CI], 2.20 [1.10-4.37]; P = 0.02).","['acutely ill adult population', '301 participants who completed Vulnerable Elders Survey (VES) at baseline']",[],"['ARDS development', 'Vulnerability', 'vulnerability and short-term outcomes (ARDS and 28-day mortality) and long-term outcomes (1-year mortality', '1-year mortality', '28-day mortality', 'VES score', 'Prehospital Vulnerability, ARDS Development, and Mortality', 'ARDS, 2 ) 28-day mortality, and 3 ) 1-year mortality', '1-year mortality in hospital survivors']","[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",[],"[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",301.0,0.201061,"Vulnerability was significantly associated with 1-year mortality in hospital survivors (35 [26.9%] vs. 13 [9.3%]; adjusted hazard ratio [95% CI], 2.20 [1.10-4.37]; P = 0.02).","[{'ForeName': 'Aluko A', 'Initials': 'AA', 'LastName': 'Hope', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Jen-Ting', 'Initials': 'JT', 'LastName': 'Chen', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Talmor', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Daryl J', 'Initials': 'DJ', 'LastName': 'Kor', 'Affiliation': 'Department of Anesthesiology and.'}, {'ForeName': 'Ognjen', 'Initials': 'O', 'LastName': 'Gajic', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Gong', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201902-116OC']
3124,33037200,Pragmatic trial on inhaled corticosteroid withdrawal in patients with COPD in general practice.,"The therapeutic value of inhaled corticosteroids (ICSs) for COPD is limited. In published RCTs, ICS could be withdrawn in COPD patients without increasing exacerbation risk when bronchodilator treatment is optimized. Here we report on the feasibility and risks of ICS withdrawal in Dutch general practice for COPD patients without an indication for ICSs. In our pragmatic trial, general practitioners decided autonomously which of their COPD patients on ICS treatment could stop this, how this was done, and whether additional bronchodilator therapy was needed. We recruited 62 COPD patients (58 analysed) who were eligible for ICS withdrawal in 79 practices. In 32 patients (55.2%, 95% CI: 42.5-67.3%) ICS was withdrawn successfully, 19 (32.8%, 95% CI: 22.1-45.6%) restarted ICS treatment within six months, 12 patients (20.7%, 95% CI: 12.3-32.8%) had a moderate exacerbation, and one patient had a severe exacerbation. ICS withdrawal was successful in just over half of the patients with COPD without an indication for ICS.",2020,"ICS was withdrawn successfully, 19 (32.8%, 95% CI: 22.1-45.6%) restarted ICS treatment within six months, 12 patients (20.7%, 95% CI: 12.3-32.8%) had a moderate exacerbation, and one patient had a severe exacerbation.","['62 COPD patients (58 analysed) who were eligible for ICS withdrawal in 79 practices', 'Dutch general practice for COPD patients without an indication for ICSs', 'patients with COPD in general practice']",['inhaled corticosteroids (ICSs'],"['ICS', 'exacerbation risk', 'severe exacerbation']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",62.0,0.152709,"ICS was withdrawn successfully, 19 (32.8%, 95% CI: 22.1-45.6%) restarted ICS treatment within six months, 12 patients (20.7%, 95% CI: 12.3-32.8%) had a moderate exacerbation, and one patient had a severe exacerbation.","[{'ForeName': 'Lisette', 'Initials': 'L', 'LastName': 'van den Bemt', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands. Lisette.vandenBemt@radboudumc.nl.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'van den Nieuwenhof', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rutjes', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'van der Meer', 'Affiliation': 'Budel Medical Centre, Budel, The Netherlands.'}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'Stege', 'Affiliation': 'Department of Pulmonology, St. Anna Hospital, Geldrop, The Netherlands.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wensing', 'Affiliation': 'Department of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Teichert', 'Affiliation': 'Department of Clinical Pharmacy and Toxicology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Tjard', 'Initials': 'T', 'LastName': 'Schermer', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-020-00198-5']
3125,33037255,Effect of warming eyelids on tear film stability and quality of life in visual display terminal users: a randomized controlled trial.,"We aimed to evaluate the effect of warming eyelids on tear-film stability and quality of life (QoL) in video display terminal (VDT) users. A prospective study was conducted and 45 volunteers with ocular symptoms and tear-film instability associated with VDT use were randomly allocated into the study (n = 22) or control groups (n = 23). Subjects in the study group used eyelid warming steamer (EWS) for 2 weeks and tear fluorescein breakup time (TBUT) after single and 2-week EWS treatment, Schirmer I test, ocular surface staining scores, meibomian gland assessment, severity of dry eye disease (DED) and QoL scores after 2-week EWS treatment were analysed. The TBUT improved after both single and 2-week EWS treatment (P = 0.023 and 0.027, respectively) in the study group. The ocular surface staining scores were significantly decreased only in the study group (P = 0.038). About 60% DED patients in the study group shifted towards non-DED and the pattern of distribution was significantly different compared to baseline (P < 0.001). The QoL scores significantly improved in the study group (P = 0.002) with a negative correlation with TBUT. In conclusion, in VDT users with short TBUT, eyelid warming steamer is effective in improving tear-film stability and QoL.",2020,The QoL scores significantly improved in the study group (P = 0.002) with a negative correlation with TBUT.,"['visual display terminal users', '45 volunteers with ocular symptoms and tear-film instability associated with VDT use']",['warming eyelids'],"['tear-film stability and quality of life (QoL', 'ocular surface staining scores', 'non-DED', 'tear film stability and quality of life', 'QoL scores', 'Schirmer I test, ocular surface staining scores, meibomian gland assessment, severity of dry eye disease (DED) and QoL scores', 'eyelid warming steamer (EWS', 'tear-film stability and QoL', 'tear fluorescein breakup time (TBUT']","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009615', 'cui_str': 'Computer terminal'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0015426', 'cui_str': 'Eyelid structure'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C1301514', 'cui_str': 'Schirmer I test'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",45.0,0.025316,The QoL scores significantly improved in the study group (P = 0.002) with a negative correlation with TBUT.,"[{'ForeName': 'Chi-Chin', 'Initials': 'CC', 'LastName': 'Sun', 'Affiliation': 'Department of Ophthalmology, Chang Gung Memorial Hospital, Keelung, Taiwan.'}, {'ForeName': 'Chia-Yi', 'Initials': 'CY', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Show Chwan Memorial Hospital, Changhua, Taiwan.'}, {'ForeName': 'Yih-Shiou', 'Initials': 'YS', 'LastName': 'Hwang', 'Affiliation': 'Department of Medicine, School of Medicine, Chang Gung University, Taoyüan, Taiwan.'}, {'ForeName': 'Igaki', 'Initials': 'I', 'LastName': 'Michihito', 'Affiliation': 'Personal Health Care Products Research Laboratories, Kao Corporation, Sumida-ku, Tokyo, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Tagami', 'Affiliation': 'Personal Health Care Products Research Laboratories, Kao Corporation, Sumida-ku, Tokyo, Japan.'}, {'ForeName': 'Ching-Hsi', 'Initials': 'CH', 'LastName': 'Hsiao', 'Affiliation': 'Department of Medicine, School of Medicine, Chang Gung University, Taoyüan, Taiwan. hsiao.chinghsi@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-73779-6']
3126,33037261,Altered metabolomic profiling of overweight and obese adolescents after combined training is associated with reduced insulin resistance.,"Exercise training and a healthy diet are the main non-pharmacological strategies for treating chronic conditions, such as obesity and insulin resistance (IR), in adolescents. However, the isolated metabolic changes caused by exercise training without dietary intervention have not yet been established. We investigated how combined training (CT) without dietary intervention altered the concentrations of serum metabolites, biochemical, anthropometric and functional parameters in overweight and obese adolescents. Thirty-seven adolescents (14.6 ± 1.05 years), of both sexes, were randomly assigned to the control group (CG, n = 19) or the training group (TG, n = 18). The CT was composed by resistance training and aerobic training performed in the same session (~ 60 min), three times a week, for 12 weeks. All assessments were performed pre and post-intervention. Metabolomics analyses were conducted using nuclear magnetic resonance spectroscopy ( 1 H NMR) in a 600 MHz spectrometer. There was a decrease in body weight (BW), body mass index (BMI), waist circumference (WC), % body fat (%BF), fasting glucose, insulin levels, and insulin resistance (IR), by HOMA-IR, in the TG. An increase in fat-free mass (FFM) was also observed in the CG. The metabolic changes were given mainly by changes in the levels of metabolites 2-oxoisocaproate (↓TG), 3-hydroxyisobutyrate (↑CG and ↓TG), glucose (↓TG), glutamine (↓CG and ↑TG) and pyruvate (↓TG). These findings demonstrate the positive effects of CT program without dietary intervention on metabolomic profile, body composition, biochemical markers, and glucose metabolism in overweight and obese adolescents.",2020,"There was a decrease in body weight (BW), body mass index (BMI), waist circumference (WC), % body fat (%BF), fasting glucose, insulin levels, and insulin resistance (IR), by HOMA-IR, in the TG.","['Thirty-seven adolescents (14.6\u2009±\u20091.05\xa0years), of both sexes', 'overweight and obese adolescents']","['CT program without dietary intervention', 'Exercise training and a healthy diet', 'exercise training without dietary intervention', 'combined training (CT) without dietary intervention']","['levels of metabolites 2-oxoisocaproate (↓TG), 3-hydroxyisobutyrate (↑CG and ↓TG), glucose (↓TG), glutamine (↓CG and ↑TG) and pyruvate (↓TG', 'concentrations of serum metabolites, biochemical, anthropometric and functional parameters', 'fat-free mass (FFM', 'body weight (BW), body mass index (BMI), waist circumference (WC), % body fat (%BF), fasting glucose, insulin levels, and insulin resistance (IR), by HOMA-IR, in the TG', 'metabolomic profile, body composition, biochemical markers, and glucose metabolism']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4068754', 'cui_str': '1.05'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0368576', 'cui_str': '2-oxoisocaproate'}, {'cui': 'C0945804', 'cui_str': '3-hydroxyisobutyrate'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.0139828,"There was a decrease in body weight (BW), body mass index (BMI), waist circumference (WC), % body fat (%BF), fasting glucose, insulin levels, and insulin resistance (IR), by HOMA-IR, in the TG.","[{'ForeName': 'Renata G', 'Initials': 'RG', 'LastName': 'Duft', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil. renataduft@gmail.com.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Ivan L P', 'Initials': 'ILP', 'LastName': 'Bonfante', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Wendell A', 'Initials': 'WA', 'LastName': 'Lopes', 'Affiliation': 'Department of Physical Education, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Larissa R', 'Initials': 'LR', 'LastName': 'da Silva', 'Affiliation': 'Department of Physical Education, University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Mara P T', 'Initials': 'MPT', 'LastName': 'Chacon-Mikahil', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Neiva', 'Initials': 'N', 'LastName': 'Leite', 'Affiliation': 'Department of Physical Education, University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Cláudia R', 'Initials': 'CR', 'LastName': 'Cavaglieri', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil. cavaglieri@fef.unicamp.br.'}]",Scientific reports,['10.1038/s41598-020-73943-y']
3127,33036179,"One Year's Treatment with the Glucagon-Like Peptide 1 Receptor Agonist Liraglutide Decreases Hepatic Fat Content in Women with Nonalcoholic Fatty Liver Disease and Prior Gestational Diabetes Mellitus in a Randomized, Placebo-Controlled Trial.","Prior gestational diabetes mellitus (pGDM) is associated with increased risk of nonalcoholic fatty liver disease (NAFLD). Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists has shown beneficial effects in NAFLD patients. We evaluated the effect of the GLP-1 analogue liraglutide on NAFLD features in women with pGDM. Eighty-two overweight/obese, nondiabetic women with pGDM were included. We performed abdominal ultrasound, transient elastography with controlled attenuation parameter (CAP), and blood sampling at baseline and after 1 year. Thirty-seven women were randomized to liraglutide (1.8 mg once-daily) and 45 to placebo. Based on the ultrasound scan, 18 women (22%) had ultrasound-verified NAFLD at baseline and of these, 10 (56%) received liraglutide treatment. After 1 year, eight participants no longer had steatosis, four in each treatment group. The number of participants who developed NAFLD was similar in the two treatment groups; five in the liraglutide group and six in the placebo group ( p = 0.74). Compared to placebo, liraglutide reduced the CAP-assessed intrahepatic fat content (-28 (-44;-11) vs. 2 (-13;18) dB/m, p < 0.01) and body weight (-4.7 (-6.4;-2.9) vs. -1.4 (-3;0.3) kg, p < 0.01). One-year's liraglutide treatment had no effect on the presence of ultrasound-diagnosed NAFLD in overweight/obese nondiabetic women with pGDM, but reduced body weight and steatosis assessed by transient elastography with CAP.",2020,The number of participants who developed NAFLD was similar in the two treatment groups; five in the liraglutide group and six in the placebo group ( p = 0.74).,"['Thirty-seven women', 'Women with Nonalcoholic Fatty Liver Disease and Prior Gestational Diabetes Mellitus', 'Prior gestational diabetes mellitus (pGDM', 'women with pGDM', 'Eighty-two overweight/obese, nondiabetic women with pGDM were included', 'NAFLD patients']","['liraglutide treatment', 'liraglutide', 'glucagon-like peptide 1 (GLP-1) receptor agonists', 'placebo, liraglutide', 'Glucagon-Like Peptide 1 Receptor Agonist Liraglutide', 'placebo', 'GLP-1 analogue liraglutide', 'Placebo']","['presence of ultrasound-diagnosed NAFLD', 'NAFLD features', 'body weight', 'CAP-assessed intrahepatic fat content', 'NAFLD', 'body weight and steatosis']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}]",82.0,0.352378,The number of participants who developed NAFLD was similar in the two treatment groups; five in the liraglutide group and six in the placebo group ( p = 0.74).,"[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Vedtofte', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Bahne', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Foghsgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Jonatan I', 'Initials': 'JI', 'LastName': 'Bagger', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Andreasen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Strandberg', 'Affiliation': 'Department of Radiology, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 4A, 2900 Hellerup, Denmark.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Gørtz', 'Affiliation': 'Department of Nuclear Medicine, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 2, 1st floor, 2900 Hellerup, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Grønbæk', 'Affiliation': 'Department of Hepatology & Gastroenterology, Aarhus University Hospital, University of Aarhus, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Jens A', 'Initials': 'JA', 'LastName': 'Svare', 'Affiliation': 'Department of Obstetrics and Gynaecology, Herlev Hospital, University of Copenhagen, Borgmester Ib Juuls Vej 21, 2730 Herlev, Denmark.'}, {'ForeName': 'Tine D', 'Initials': 'TD', 'LastName': 'Clausen', 'Affiliation': 'Department of Gynaecology and Obstetrics, Nordsjaellands Hospital, University of Copenhagen, Dyrehavevej 29, 3400 Hillerød, Denmark.'}, {'ForeName': 'Elisabeth R', 'Initials': 'ER', 'LastName': 'Mathiesen', 'Affiliation': 'Center for Pregnant Women with Diabetes, Department of Endocrinology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Damm', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Lise L', 'Initials': 'LL', 'LastName': 'Gluud', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}]",Journal of clinical medicine,['10.3390/jcm9103213']
3128,33036224,Vitamin K Intake in Chronic Stroke: Implications for Dietary Recommendations.,"Previous research has identified a possible association between vitamin K intake and cardiometabolic disease. This could mean that the assessment of vitamin K intake is a meaningful tool when monitoring individuals with preexisting cardiovascular disease. Sixty chronic stroke survivors (men and women, body mass index (BMI) 30.36 ± 6.61 kg/m 2 , age 61.7 ± 7.2 years) completed food records which were analyzed for energy, macronutrient, micronutrient, and food group servings. Participants were divided into two groups: below vitamin K recommendation (BEL, n = 49) and met vitamin K recommendation (MET, n = 11). Energy and macronutrient intake did not differ between groups (all p > 0.127). Vegetable intake was higher in the MET group ( p = 0.0001). Vitamin K intake was higher in the MET group ( p = 0.0001). Calcium ( p = 0.003), vitamin A ( p = 0.007), and vitamin E ( p = 0.005) intakes were higher in the MET group. There were no differences in sodium, potassium, vitamin D, vitamin C, and iron intakes between groups (all p > 0.212). In this sample of chronic stroke survivors, 82% reported consuming below the Dietary Reference Intake (DRI) for vitamin K. Given that the majority of this study population did not reach the DRI for vitamin K, it is advisable to promote the adequate intake of food rich in vitamin K. Further work is needed to determine the significance of low vitamin K intake in this population.",2020,Vegetable intake was higher in the MET group ( p = 0.0001).,"['Sixty chronic stroke survivors (men and women, body mass index (BMI) 30.36 ± 6.61 kg/m 2 , age 61.7 ± 7.2 years) completed food records which were analyzed for energy, macronutrient, micronutrient, and food group servings', 'individuals with preexisting cardiovascular disease', 'Chronic Stroke']","['vitamin K intake', 'below vitamin K recommendation (BEL, n = 49) and met vitamin K recommendation', 'Vitamin K Intake']","['Vegetable intake', 'Vitamin K intake', 'vitamin E', 'Energy and macronutrient intake', 'sodium, potassium, vitamin D, vitamin C, and iron intakes']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C2317598', 'cui_str': 'Vitamin K intake'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}]","[{'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C2317598', 'cui_str': 'Vitamin K intake'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0518043', 'cui_str': 'Iron intake'}]",,0.0550242,Vegetable intake was higher in the MET group ( p = 0.0001).,"[{'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Wessinger', 'Affiliation': 'VA Research Service, Department of Medicine, Division of Gerontology and Geriatric Medicine at the University of Maryland School of Medicine, and the Baltimore VA Medical Center Geriatric Research, Education and Clinical Center (GRECC), VA Maryland Health Care System, Baltimore, MD 21201, USA.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Hafer-Macko', 'Affiliation': 'VA Research Service, Department of Medicine, Division of Gerontology and Geriatric Medicine at the University of Maryland School of Medicine, and the Baltimore VA Medical Center Geriatric Research, Education and Clinical Center (GRECC), VA Maryland Health Care System, Baltimore, MD 21201, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'S Ryan', 'Affiliation': 'VA Research Service, Department of Medicine, Division of Gerontology and Geriatric Medicine at the University of Maryland School of Medicine, and the Baltimore VA Medical Center Geriatric Research, Education and Clinical Center (GRECC), VA Maryland Health Care System, Baltimore, MD 21201, USA.'}]",Nutrients,['10.3390/nu12103059']
3129,33039693,Semaglutide for the treatment of non-alcoholic steatohepatitis: Trial design and comparison of non-invasive biomarkers.,"Non-alcoholic steatohepatitis (NASH) is a chronic liver disease. There is a clear need to develop pharmacological treatment for patients with NASH as well as biomarkers that can diagnose the disease. We describe a trial of semaglutide treatment for NASH, identify key patient characteristics and compare the relationship of patient characteristics and non-invasive biomarkers/scores. NCT02970942 is a randomised, double-blind, placebo-controlled, multi-national Phase 2 trial of daily subcutaneous semaglutide (0.1 mg, 0.2 mg, 0.4 mg) in patients with biopsy-confirmed NASH, F1-F3 fibrosis, NAFLD Activity Score ≥ 4, and body mass index (BMI) > 25 kg/m 2 . Exploratory analyses were performed to evaluate correlations between baseline parameters and biomarkers in NASH. Mean (standard deviation [SD]) age of 320 randomised patients was 55 (11) years, mean BMI was 36 (6) kg/m 2 , and 199 (62%) had type 2 diabetes. Of the total patients, 28% had F1 fibrosis, 23% had F2 fibrosis and 49% had F3 fibrosis. The highest area under the receiver operating characteristic curve (0.69) for accuracy in classifying fibrosis stage, F2-3 versus F1, was observed for Fib-4 and Enhanced Liver Fibrosis (ELF). No substantial correlation between BMI or other clinical or biochemical parameters and fibrosis stage was observed. In this large Phase 2 trial of semaglutide treatment for NASH, the clinical profile of enrolled patients was typical for patients with NASH. Of the investigated biomarkers/scores, ELF and Fib-4 showed the most apparent correlation in classifying fibrosis stage, but had only moderate predictive value.",2020,"Of the investigated biomarkers/scores, ELF and Fib-4 showed the most apparent correlation in classifying fibrosis stage, but had only moderate predictive value.","['enrolled patients was typical for patients with NASH', 'patients with biopsy-confirmed NASH', 'patients with NASH', '\u202f25', 'age of 320 randomised patients was 55 (11) years, mean BMI was 36 (6) kg/m 2 , and 199 (62%) had type 2 diabetes']","['daily subcutaneous semaglutide', 'placebo']","['Mean (standard deviation [SD', 'F3 fibrosis', '≥\u202f4, and body mass index (BMI', 'F2 fibrosis', 'F1 fibrosis', 'F1-F3 fibrosis, NAFLD Activity Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0910435', 'cui_str': 'AM 36'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0949122,"Of the investigated biomarkers/scores, ELF and Fib-4 showed the most apparent correlation in classifying fibrosis stage, but had only moderate predictive value.","[{'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Radcliffe Department of Medicine, University of Oxford, Oxford, OX3 9DU, UK. Electronic address: stephenharrison87@gmail.com.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Calanna', 'Affiliation': 'Novo Nordisk A/S, 2860 Søborg, Denmark. Electronic address: sca@novonordisk.com.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Cusi', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism, University of Florida, Gainesville, FL 32608, USA; Endocrinology, Diabetes and Metabolism, Malcom Randall VA Medical Center, Gainesville, FL 32608, USA. Electronic address: Kenneth.Cusi@medicine.ufl.edu.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Linder', 'Affiliation': 'Novo Nordisk A/S, 2860 Søborg, Denmark. Electronic address: MLIX@novonordisk.com.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Okanoue', 'Affiliation': 'Department of Gastroenterology & Hepatology, Saiseikai Suita Hospital, Suita, Japan. Electronic address: okanoue@suita.saiseikai.or.jp.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Ratziu', 'Affiliation': 'Sorbonne University, ICAN - Institute for Cardiometabolism and Nutrition, Hôpital Pitié Salpêtrière, 75013 Paris, France. Electronic address: vlad.ratziu@inserm.fr.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sanyal', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Internal Medicine, Virginia Commonwealth University, Richmond, VA 23284, USA. Electronic address: arun.sanyal@vcuhealth.org.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Sejling', 'Affiliation': 'Novo Nordisk A/S, 2860 Søborg, Denmark. Electronic address: asji@novonordisk.com.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Newsome', 'Affiliation': 'National Institute for Health Research Birmingham Biomedical Research Centre and Liver Unit at University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Centre for Liver & Gastrointestinal Research, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham B15 2TT, UK. Electronic address: P.N.Newsome@bham.ac.uk.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106174']
3130,33039717,Nasal function and cardio-respiratory capacity of adolescent with external nasal dilator.,"BACKGROUND
the external nasal dilator (END) has been employed for the purpose of aiding sporting performance. The objective of this study was to evaluate nasal function and cardio-respiratory capacity in healthy adolescent athletes using the END.
METHODS
double-blind, crossover clinical trial in which adolescents were evaluated while using the experimental and placebo END during physical exercise. Values for peak nasal inspiratory flow (PNIF), nasal resistance (NR) and maximal oxygen uptake (VO 2 max) were obtained in randomized order. Additionally, the rating of perceived exertion (RPE) after the cardio-respiratory test was assessed.
RESULTS
for the 71 adolescents evaluated, the use of the experimental END, compared to the placebo, produced a significant improvement in values of PNIF (177.4 ± 20.9 L/min and 172.8 ± 20.2 L/min) (p = 0.020), NR (0.24 ± 0.16 and 0.27 ± 0.16) (p = 0.007), VO 2 max. (39.5 ± 5.2 mL/kg. min-1 and 37.5 ± 5.2 mL/kg. min-1) (p < 0.001) and RPE (6.0 ± 2.2 and 5.5 ± 2.4) (p < 0.001), respectively.
CONCLUSION
the END reduced NR, increased PNIF and improved VO 2 max. In addition, it improved RPE after the maximal cardio-respiratory test. The use of the END can significantly improve nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion during a maximal test involving adolescent athletes.",2020,"The use of the END can significantly improve nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion during a maximal test involving adolescent athletes.","['adolescent with external nasal dilator', 'healthy adolescent athletes', 'adolescent athletes']","['placebo', 'external nasal dilator (END']","['rating of perceived exertion (RPE', 'Nasal function and cardio-respiratory capacity', 'values of PNIF', 'nasal function and cardio-respiratory capacity', 'PNIF and improved VO 2 max', 'nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion', 'peak nasal inspiratory flow (PNIF), nasal resistance (NR) and maximal oxygen uptake (VO 2 max']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0180437', 'cui_str': 'Nasal dilator'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0180437', 'cui_str': 'Nasal dilator'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429205', 'cui_str': 'Nasal peak inspiratory flow'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",,0.146487,"The use of the END can significantly improve nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion during a maximal test involving adolescent athletes.","[{'ForeName': 'Carlos Henrique', 'Initials': 'CH', 'LastName': 'Santos Ferreira', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Ricardo Reis', 'Initials': 'RR', 'LastName': 'Dinardi', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil; Pontifical Catholic University of Minas Gerais, Department of Physical Education. Belo Horizonte, MG, Brazil. Electronic address: dinardi06@hotmail.com.'}, {'ForeName': 'Cássio', 'Initials': 'C', 'LastName': 'da Cunha Ibiapina', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Ribeiro de Andrade', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110430']
3131,33039810,"Effect of urea cream on sorafenib-associated hand-foot skin reaction in patients with hepatocellular carcinoma: A multicenter, randomised, double-blind controlled study.","BACKGROUND
Hand-foot skin reaction (HFSR) is the most common adverse event during sorafenib treatment in patients with hepatocellular carcinoma (HCC). In the present study, we aimed to investigate the role of urea cream in the prevention of HFSR or amelioration of HFSR severity.
PATIENTS AND METHODS
Patients with HCC were treated with either placebo cream or urea cream for 12 weeks concomitantly with sorafenib treatment. HFSR development, the Hand-Foot Skin Reaction and Quality of Life (HF-QoL) questionnaire score, and adverse events were assessed at 2, 4, 8 and 12 weeks.
RESULTS
Of the 288 patients, 247 patients, with 117 patients in the placebo control group and 130 patients in the urea cream group, were analysed. The urea cream group showed a trend towards a lower cumulative incidence of any-grade HFSR (log-rank, P = 0.247) and severe HFSR of grade II or higher (log-rank, P = 0.394) without statistical significance. In the incidence by time point, the incidence of severe HFSR of grade II or higher was significantly lower in the urea cream group than in the placebo control group at 2 weeks (13.8% versus 23.9%, P = 0.042). The urea cream group showed a significantly better HF-QoL questionnaire score than the placebo control group (11.8 versus 19.7, P = 0.014) at 12 weeks.
CONCLUSIONS
Treatment with urea cream showed a lower incidence of severe sorafenib-induced HFSR at 2 weeks and reduced the tendency of HFSR development in HCC patients. Therefore, treatment with urea cream may be considered for prophylaxis or improvement of HFSR grade in HCC patients treated with sorafenib.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT03212625).",2020,"The urea cream group showed a significantly better HF-QoL questionnaire score than the placebo control group (11.8 versus 19.7, P = 0.014) at 12 weeks.
","['Patients with HCC', 'patients with hepatocellular carcinoma', 'patients with hepatocellular carcinoma (HCC', '288 patients, 247 patients, with 117 patients in the placebo control group and 130 patients in the urea cream group']","['Hand-foot skin reaction (HFSR', 'placebo cream or urea cream', 'sorafenib treatment', 'urea cream']","['incidence of severe HFSR of grade II or higher', 'HFSR development, the Hand-Foot Skin Reaction and Quality of Life (HF-QoL) questionnaire score, and adverse events', 'HF-QoL questionnaire score', 'cumulative incidence of any-grade HFSR', 'tendency of HFSR development', 'severe HFSR of grade II', 'sorafenib-associated hand-foot skin reaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",288.0,0.149479,"The urea cream group showed a significantly better HF-QoL questionnaire score than the placebo control group (11.8 versus 19.7, P = 0.014) at 12 weeks.
","[{'ForeName': 'Young-Sun', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea. Electronic address: lys810@korea.ac.kr.'}, {'ForeName': 'Young K', 'Initials': 'YK', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea. Electronic address: kjhhepar@naver.com.'}, {'ForeName': 'Sung B', 'Initials': 'SB', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Chonnam National University Medical School, South Korea. Electronic address: portalvein@naver.com.'}, {'ForeName': 'Do Y', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Yonsei Liver Center, Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Moon Y', 'Initials': 'MY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christan Hospital, South Korea.'}, {'ForeName': 'Hyung J', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yeon S', 'Initials': 'YS', 'LastName': 'Seo', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ki T', 'Initials': 'KT', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Pusan National University College of Medicine, Liver center, Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'Young M', 'Initials': 'YM', 'LastName': 'Hong', 'Affiliation': 'Department of Internal Medicine, Pusan National University College of Medicine, Liver center, Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, South Korea.'}, {'ForeName': 'Hyun W', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, South Korea.'}, {'ForeName': 'Hyung J', 'Initials': 'HJ', 'LastName': 'Yim', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Byoung K', 'Initials': 'BK', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Keimyung University School of Medicine, South Korea.'}, {'ForeName': 'Eun S', 'Initials': 'ES', 'LastName': 'Jang', 'Affiliation': 'Department of Intetnal Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi, South Korea.'}, {'ForeName': 'Jae Y', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sang Y', 'Initials': 'SY', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Dongnam Institute of Radiological & Medical Sciences, South Korea.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.09.012']
3132,33045224,A randomized clinical trial to evaluate the efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valve and atrial fibrillation or flutter: Rationale and design of the RIVER trial.,"The efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valves and atrial fibrillation or flutter remain uncertain. DESIGN: RIVER was an academic-led, multicenter, open-label, randomized, non-inferiority trial with blinded outcome adjudication that enrolled 1005 patients from 49 sites in Brazil. Patients with a bioprosthetic mitral valve and atrial fibrillation or flutter were randomly assigned (1:1) to rivaroxaban 20 mg once daily (15 mg in those with creatinine clearance <50 mL/min) or dose-adjusted warfarin (target international normalized ratio 2.0-30.); the follow-up period was 12 months. The primary outcome was a composite of all-cause mortality, stroke, transient ischemic attack, major bleeding, valve thrombosis, systemic embolism, or hospitalization for heart failure. Secondary outcomes included individual components of the primary composite outcome, bleeding events, and venous thromboembolism. SUMMARY: RIVER represents the largest trial specifically designed to assess the efficacy and safety of a direct oral anticoagulant in patients with bioprosthetic mitral valves and atrial fibrillation or flutter. The results of this trial can inform clinical practice and international guidelines.",2020,"The primary outcome was a composite of all-cause mortality, stroke, transient ischemic attack, major bleeding, valve thrombosis, systemic embolism, or hospitalization for heart failure.","['patients with bioprosthetic mitral valves and atrial fibrillation or flutter', 'patients with bioprosthetic mitral valve and atrial fibrillation or flutter', 'Patients with a bioprosthetic mitral valve and atrial fibrillation or flutter', 'enrolled 1005 patients from 49 sites in Brazil', 'patients with bioprosthetic mitral valves and atrial fibrillation or flutter remain uncertain']","['rivaroxaban 20mg once daily (15mg in those with creatinine clearance <50mL/min) or dose-adjusted warfarin', 'rivaroxaban']","['efficacy and safety', 'individual components of the primary composite outcome, bleeding events, and venous thromboembolism', 'composite of all-cause mortality, stroke, transient ischemic attack, major bleeding, valve thrombosis, systemic embolism, or hospitalization for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}]","[{'cui': 'C3248003', 'cui_str': 'rivaroxaban 20 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",1005.0,0.16174,"The primary outcome was a composite of all-cause mortality, stroke, transient ischemic attack, major bleeding, valve thrombosis, systemic embolism, or hospitalization for heart failure.","[{'ForeName': 'Helio P', 'Initials': 'HP', 'LastName': 'Guimarães', 'Affiliation': 'Research Institute - Heart Hospital (HCor), São Paulo, Brazil; Hospital Israelita Albert Einstein, São Paulo-SP, Brazil. Electronic address: heliopg@yahoo.com.br.'}, {'ForeName': 'Pedro G M', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'Research Institute - Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Idelzuita L', 'Initials': 'IL', 'LastName': 'Liporace', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.'}, {'ForeName': 'Roney O', 'Initials': 'RO', 'LastName': 'Sampaio', 'Affiliation': 'Incor - Instituto do Coração do HCFMUSP, São Paulo, Brazil.'}, {'ForeName': 'Flávio', 'Initials': 'F', 'LastName': 'Tarasoutchi', 'Affiliation': 'Incor - Instituto do Coração do HCFMUSP, São Paulo, Brazil.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Paixão', 'Affiliation': 'Incor - Instituto do Coração do HCFMUSP, São Paulo, Brazil.'}, {'ForeName': 'Conrado R', 'Initials': 'CR', 'LastName': 'Hoffmann-Filho', 'Affiliation': 'Hospital Regional Hans Dieter Schmidt - Joinvile, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Patriota', 'Affiliation': 'Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho, Brazil.'}, {'ForeName': 'Tiago L L', 'Initials': 'TLL', 'LastName': 'Leiria', 'Affiliation': 'Instituto de Cardiologia do Rio Grande do Sul (FUC), Porto Alegre, Brazil.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Lamprea', 'Affiliation': 'Procape, Recife, Brazil.'}, {'ForeName': 'Dalton B', 'Initials': 'DB', 'LastName': 'Precoma', 'Affiliation': 'Sociedade Hospitalar Angelina Caron, Campina Grande do Sul, Brazil.'}, {'ForeName': 'Fernando A', 'Initials': 'FA', 'LastName': 'Atik', 'Affiliation': 'Instituto de Cardiologia do Distrito Federal, Brasília, Brazil.'}, {'ForeName': 'Fabio S', 'Initials': 'FS', 'LastName': 'Silveira', 'Affiliation': 'Clínica do Coração Sergipe - Aracajú, Brazil.'}, {'ForeName': 'Fabio R', 'Initials': 'FR', 'LastName': 'Farias', 'Affiliation': 'Quanta Diagnóstico e Terapia, Curitiba, Brazil.'}, {'ForeName': 'Diogo O', 'Initials': 'DO', 'LastName': 'Barreto', 'Affiliation': 'Hospital Evangélico de Vila Velha, Vila Velha, Brazil.'}, {'ForeName': 'Adail P', 'Initials': 'AP', 'LastName': 'Almeida', 'Affiliation': 'Unidade Médico Cirúrgica - Unimec, Vitória da Conquista, Brazil.'}, {'ForeName': 'Alexandre C', 'Initials': 'AC', 'LastName': 'Zilli', 'Affiliation': 'Hospital de Caridade São Vicente de Paulo, Jundiaí, Brazil.'}, {'ForeName': 'João D', 'Initials': 'JD', 'LastName': 'de Souza Neto', 'Affiliation': 'Hospital Messejana, Ceará, Brazil.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Cavalcante', 'Affiliation': 'Hospital Regional de Presidente Prudente, Presidente Prudente, Brazil.'}, {'ForeName': 'Fernando A M S', 'Initials': 'FAMS', 'LastName': 'Figueira', 'Affiliation': 'IMIP - Instituto de Medicina Integral Professor Fernando Figueira, Recife, Brazil.'}, {'ForeName': 'Roque A', 'Initials': 'RA', 'LastName': 'Junior', 'Affiliation': 'HUPES-Hospital Universitário Prof Edgard Santos, Salvador, Brazil.'}, {'ForeName': 'Valdir A', 'Initials': 'VA', 'LastName': 'Moisés', 'Affiliation': 'UNIFESP, São Paulo, Brazil.'}, {'ForeName': 'Cezar E', 'Initials': 'CE', 'LastName': 'Mesas', 'Affiliation': 'Hospital de Universidade Estadual de Londrina, Londrina, Brazil.'}, {'ForeName': 'Roberto V', 'Initials': 'RV', 'LastName': 'Ardito', 'Affiliation': 'IMC - Instituto de Moléstias Cardiovasculares, São José do Rio Preto, Brazil.'}, {'ForeName': 'Paulo S A', 'Initials': 'PSA', 'LastName': 'Kalil', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Maria S M O', 'Initials': 'MSMO', 'LastName': 'Paiva', 'Affiliation': 'Eurolatino Natal Center, Natal, Brazil.'}, {'ForeName': 'Jaime G A', 'Initials': 'JGA', 'LastName': 'Maldonado', 'Affiliation': 'Serviço de Eletrofisiologia e Marca-Passo do Hospital Universitário Francisca Mendes (HUFM)-Manaus, Brazil.'}, {'ForeName': 'Carlos E B', 'Initials': 'CEB', 'LastName': 'de Lima', 'Affiliation': 'Cardiolima Piauí, Teresina, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': ""D'Oliveira Vieira"", 'Affiliation': 'Hospital e Clínica São Roque, Ipiaú, Brazil.'}, {'ForeName': 'Ligia', 'Initials': 'L', 'LastName': 'Laranjeira', 'Affiliation': 'Research Institute - Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Flávia', 'Initials': 'F', 'LastName': 'Kojima', 'Affiliation': 'Research Institute - Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Damiani', 'Affiliation': 'Research Institute - Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Renato H', 'Initials': 'RH', 'LastName': 'Nakagawa', 'Affiliation': 'Research Institute - Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Juliana R Y', 'Initials': 'JRY', 'LastName': 'Dos Santos', 'Affiliation': 'Research Institute - Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Bruna S', 'Initials': 'BS', 'LastName': 'Sampaio', 'Affiliation': 'Research Institute - Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Viviane B', 'Initials': 'VB', 'LastName': 'Campos', 'Affiliation': 'Research Institute - Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Jose F K', 'Initials': 'JFK', 'LastName': 'Saraiva', 'Affiliation': 'Instituto de Pesquisa Clínica de Campinas, Campinas, Brazil; Sociedade de Cardiologia do Estado de São Paulo (SOCESP), Sao Paulo, Brazil.'}, {'ForeName': 'Francisco H', 'Initials': 'FH', 'LastName': 'Fonseca', 'Affiliation': 'UNIFESP, São Paulo, Brazil; Sociedade de Cardiologia do Estado de São Paulo (SOCESP), Sao Paulo, Brazil.'}, {'ForeName': 'Ibraim M', 'Initials': 'IM', 'LastName': 'Pinto', 'Affiliation': 'Sociedade de Cardiologia do Estado de São Paulo (SOCESP), Sao Paulo, Brazil.'}, {'ForeName': 'Carlos C', 'Initials': 'CC', 'LastName': 'Magalhães', 'Affiliation': 'Sociedade de Cardiologia do Estado de São Paulo (SOCESP), Sao Paulo, Brazil.'}, {'ForeName': 'Joao F M', 'Initials': 'JFM', 'LastName': 'Ferreira', 'Affiliation': 'Incor - Instituto do Coração do HCFMUSP, São Paulo, Brazil; Sociedade de Cardiologia do Estado de São Paulo (SOCESP), Sao Paulo, Brazil.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute (DCRI), Durham-NC.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Pavanello', 'Affiliation': 'Research Institute - Heart Hospital (HCor), São Paulo, Brazil; Sociedade de Cardiologia do Estado de São Paulo (SOCESP), Sao Paulo, Brazil.'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Research Institute - Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Research Institute - Heart Hospital (HCor), São Paulo, Brazil; Hospital Israelita Albert Einstein, São Paulo-SP, Brazil; Sociedade de Cardiologia do Estado de São Paulo (SOCESP), Sao Paulo, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.10.001']
3133,33045287,"Mirabegron Vs Placebo Add-on Therapy in Men With Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Safety Analysis From the Randomized, Phase 4 PLUS Study.","OBJECTIVE
To analyze the safety of mirabegron add-on therapy in men with overactive bladder symptoms concurrently receiving tamsulosin for lower urinary tract symptoms associated with benign prostatic hyperplasia.
METHODS
The Phase 4 PLUS study comprised a 4-week run-in period (tamsulosin [0.4 mg]) and a 12-week randomized treatment period (add-on treatment: mirabegron [25 mg] or placebo). Doses were increased to mirabegron 50 mg or matched placebo after 4 weeks. Safety assessments: treatment-emergent adverse events (TEAEs), vital signs, 12-lead electrocardiograms, and changes in postvoid residual volume and maximum urinary flow (Q max ).
RESULTS
The safety analysis set included 352 tamsulosin plus mirabegron (TAM + MIRA) and 354 tamsulosin plus placebo (TAM + PL) patients. The frequency of overall TEAEs was higher with TAM + PL, although a higher incidence of drug-related TEAEs was observed with TAM + MIRA. Most TEAEs were mild or moderate in severity. Drug-related serious TEAEs were reported for 3 patients (2 TAM + MIRA patients: acute myocardial infarction with cerebral infarction and angina pectoris, 1 TAM + PL patient: lacunar stroke). Hypertension, headache, and nasopharyngitis were the most common TEAEs. Special interest TEAEs were infrequently reported. The most common was urinary retention and 2 TAM + MIRA patients required catheterization (neither led to discontinuation). No major changes in blood pressure or pulse rate were noted and similar electrocardiogram parameters were observed for both groups. Changes in mean postvoid residual volume and Q max were not clinically meaningful.
CONCLUSION
No unexpected safety concerns were noted in men receiving tamsulosin for lower urinary tract symptoms associated with benign prostatic hyperplasia who subsequently received mirabegron add-on therapy.",2020,"The frequency of overall TEAEs was higher with TAM+PL, although a higher incidence of drug-related TEAEs was observed with TAM+MIRA.","['Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia', 'patients', 'three patients (two TAM+MIRA patients: acute myocardial infarction with cerebral infarction and angina pectoris, one TAM+PL patient: lacunar stroke', 'men with overactive bladder symptoms concurrently receiving tamsulosin for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH']","['tamsulosin plus mirabegron (TAM+MIRA) and 354 tamsulosin plus placebo (TAM+PL', '4-week run-in period (tamsulosin [0.4 mg]) and a 12-week randomized treatment period (add-on treatment: mirabegron [25 mg] or placebo', 'tamsulosin', 'Mirabegron versus Placebo', 'mirabegron 50 mg or matched placebo']","['frequency of overall TEAEs', 'Safety assessments: treatment-emergent adverse events (TEAEs), vital signs, 12-lead electrocardiograms (ECGs), and changes in post-void residual (PVR) volume and maximum urinary flow (Q max ', 'ECG parameters', 'Hypertension, headache, and nasopharyngitis', 'blood pressure or pulse rate', 'mean PVR volume and Q max']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3178801', 'cui_str': 'Lacunar stroke'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C3474335', 'cui_str': 'mirabegron 50 MG'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}]",,0.105879,"The frequency of overall TEAEs was higher with TAM+PL, although a higher incidence of drug-related TEAEs was observed with TAM+MIRA.","[{'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Herschorn', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, United Kingdom; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, United Kingdom; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY. Electronic address: Sender.Herschorn@sunnybrook.ca.'}, {'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'McVary', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, United Kingdom; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, United Kingdom; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cambronero Santos', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, United Kingdom; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, United Kingdom; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Foley', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, United Kingdom; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, United Kingdom; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY.'}, {'ForeName': 'Rita M', 'Initials': 'RM', 'LastName': 'Kristy', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, United Kingdom; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, United Kingdom; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY.'}, {'ForeName': 'Nurul', 'Initials': 'N', 'LastName': 'Choudhury', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, United Kingdom; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, United Kingdom; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hairston', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, United Kingdom; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, United Kingdom; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': 'Department of Surgery/Urology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL; Department of Urology, Infanta Leonor Hospital, Madrid, Spain; Department of Urology, Royal Berkshire Hospital, Reading, United Kingdom; Astellas Pharma Global Development Inc., Northbrook, IL; Astellas Pharma Europe Ltd., Chertsey, United Kingdom; Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY.'}]",Urology,['10.1016/j.urology.2020.09.040']
3134,33046584,Web-Based Tailored Messaging to Increase Vaccination: A Randomized Clinical Trial.,"BACKGROUND
To increase vaccine acceptance, we created a Web-based the ""Vaccines and Your Baby"" intervention (VAYB) that provided new parents with vaccine information messages tailored to vaccine beliefs and values. We evaluated the effectiveness of the VAYB by comparing timely uptake of infant vaccines to an untailored version of the intervention (UT) or usual care intervention (UC) only.
METHODS
Between April 2016 and June 2019, we conducted a randomized clinical trial. Pregnant women and new parents were randomly assigned to the VAYB, UT, or UC arms. In the VAYB and UT arms, participants were exposed to interventions at 4 time points from pregnancy until their child was 15 months of age. The primary outcome was up-to-date status for recommended vaccines from birth to 200 days of age. A modified intent-to-treat analysis was conducted. Data were analyzed with logistic regression to generate odds ratios (ORs) and 95% confidence intervals (CIs).
RESULTS
We enrolled 824 participants (276 VAYB, 274 UT, 274 UC), 143 (17.4%) of whom were lost to follow-up. The up-to-date rates in the VAYB, UT, and UC arms were 91.44%, 92.86%, and 92.31%, respectively. Infants in the VAYB arm were not more likely to be up to date than infants in the UC arm (OR = 0.89; 95% CI, 0.45-1.76) or in the UT arm (OR = 0.82; 95% CI, 0.42-1.63). The odds of being up to date did not differ between UT and UC arms (OR = 1.08; 95% CI, 0.54-2.18).
CONCLUSIONS
Delivering Web-based vaccine messages tailored to parents' vaccine attitudes and values did not positively impact the timely uptake of infant vaccines.",2020,"The odds of being up to date did not differ between UT and UC arms (OR = 1.08; 95% CI, 0.54-2.18).
","['Pregnant women and new parents', 'We enrolled 824 participants (276 VAYB, 274 UT, 274 UC), 143 (17.4%) of whom were lost to follow-up', 'Between April 2016 and June 2019']","['Web-Based Tailored Messaging to Increase Vaccination', 'Delivering Web-based vaccine messages', 'intervention (UT) or usual care intervention (UC) only']",['up-to-date status'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",824.0,0.196029,"The odds of being up to date did not differ between UT and UC arms (OR = 1.08; 95% CI, 0.54-2.18).
","[{'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Glanz', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado; jason.m.glanz@kp.org.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Wagner', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Komal J', 'Initials': 'KJ', 'LastName': 'Narwaney', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pyrzanowski', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science and.'}, {'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Kwan', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science and.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Sevick', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science and.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Dempsey', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science and.'}]",Pediatrics,['10.1542/peds.2020-0669']
3135,33028623,Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850).,"OBJECTIVE
To investigate whether neoadjuvant chemotherapy followed by interval debulking surgery is superior to primary debulking surgery in terms of perioperative complications and progression-free survival, in advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high tumor load.
METHODS
Patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (stage IIIC-IV) underwent laparoscopy. Patients with high tumor load assessed by a standardized laparoscopic predictive index were randomly assigned (1:1 ratio) to undergo either primary debulking surgery followed by adjuvant chemotherapy (arm A), or neoadjuvant chemotherapy followed by interval debulking surgery and adjuvant chemotherapy (arm B). Co-primary outcome measures were progression-free survival and post-operative complications; secondary outcomes were overall survival, and quality of life. Survival analyses were performed on an intention-to-treat population.
RESULTS
171 patients were randomly assigned to primary debulking surgery (n=84) versus neoadjuvant chemotherapy (n=87). Rates of complete resection (R0) were different between the arms (47.6% in arm A vs 77.0% in arm B; p=0.001). 53 major postoperative complications were registered, mainly distributed in arm A compared with arm B (25.9% vs 7.6%; p=0.0001). All patients were included in the intent-to-treat analysis. With an overall median follow-up of 59 months (95% CI 53 to 64), 142 (83.0%) disease progressions/recurrences and 103 deaths (60.2%) occurred. Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56).
CONCLUSIONS
Neoadjuvant chemotherapy and primary debulking surgery have the same efficacy when used at their maximal possibilities, but the toxicity profile is different.",2020,"Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56).
","['Patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (stage IIIC-IV) underwent laparoscopy', '171 patients', 'advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high tumor load', 'Patients with high tumor load assessed by a standardized laparoscopic predictive index']","['primary debulking surgery', 'primary debulking surgery versus neoadjuvant chemotherapy', 'primary debulking surgery followed by adjuvant chemotherapy (arm A), or neoadjuvant chemotherapy followed by interval debulking surgery and adjuvant chemotherapy (arm B', 'neoadjuvant chemotherapy followed by interval debulking surgery', 'neoadjuvant chemotherapy']","['progression-free survival and post-operative complications; secondary outcomes were overall survival, and quality of life', 'Median progression-free and overall survival', 'disease progressions/recurrences and 103 deaths', 'toxicity profile', 'advanced epithelial ovarian cancer', '53 major postoperative complications', 'Rates of complete resection (R0']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0015560', 'cui_str': 'Fallopian tube structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}]",171.0,0.400373,"Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fagotti', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy annafagotti70@gmail.com.'}, {'ForeName': 'Maria Gabriella', 'Initials': 'MG', 'LastName': 'Ferrandina', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Vizzielli', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Pasciuto', 'Affiliation': 'Statistics Technology Archiving Research (STAR) Center, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fanfani', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Gallotta', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Pasquale Alessandro', 'Initials': 'PA', 'LastName': 'Margariti', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Chiantera', 'Affiliation': 'Department of Gynecologic Oncology, ARNAS Civico Di Cristina Benfratelli, Palermo, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Costantini', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Gueli Alletti', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cosentino', 'Affiliation': 'Gynecologic Oncology, Gemelli Molise spa, Università Cattolica del Sacro Cuore, Campobasso, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001640']
3136,33029789,Effect of Supplemental Enteral Fish Oil on the Development of Psychological Complications in Critically Ill Multiple-Trauma Patients: 6 Months' Follow-Up.,"BACKGROUND
Posttraumatic stress disorder (PTSD) is common in intensive care unit (ICU) patients. Defic it intake of ω-3 polyuns aturated fatty ac ids (PUFAs) may be as sociated with developm ent of PTSD.
METHODS
This study randomized mechanically ventilated patients suffering from multiple trauma (n = 150) into 2 groups: a study and a control group that received enteral feeding with or without fish oil. Fifty-one patients were interviewed 6 months after discharge from the ICU. Psychometric parameters of PTSD were assessed by questionnaires. The fatty acid composition of erythrocyte membranes was performed by homogenization of the cells in hexane-isopropanol.
RESULTS
No differences were found in baseline characteristics between the groups. Erythrocyte membrane composition showed significantly higher concentrations of ω-3 fatty acids in the study group. Anxiety and depression symptoms were correlated with an increase in eicosapentaenoic acid (EPA) on days 4 and 8 for depression and EPA on day 4 and docosahexaenoic acid (DHA) on day 8 for anxiety. Total ω-3 content was positively correlated with anxiety and depression as well. An inverse correlation was found between DHA and EPA in the treatment group and with the total ω-3 and DHA in the control group for the Brief Illness Perceptions Questionnaire.
CONCLUSION
Administration of an ω-3 PUFA-enriched diet during the ICU stay did not prevent development of PTSD in trauma patients 6 months after discharge from ICU.",2020,Anxiety and depression symptoms were correlated with an increase in EPA on day 4 and 8 for depression and EPA on day 4 and DHA on day 8 for anxiety.,"['mechanically ventilated patients suffering from multiple trauma (n = 150) into 2 groups', 'multiple trauma patients', 'ICU patients', 'Critically Ill Multiple Trauma Patients', 'Fifty one patients were interviewed 6 month after discharge from ICU']","['n-3 PUFA', ""omega 3 PUFA's, gamma linolenic acid (GLA) and micronutrients"", 'enteral feeding with or without fish oil', 'Supplemental Enteral Fish Oil']","['Anxiety and depression symptoms', 'Psychological Complications']","[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",150.0,0.0232287,Anxiety and depression symptoms were correlated with an increase in EPA on day 4 and 8 for depression and EPA on day 4 and DHA on day 8 for anxiety.,"[{'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Kagan', 'Affiliation': 'Department of Intensive Care and Institute for Nutrition Research, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Mesilati-Stahy', 'Affiliation': 'Department of Intensive Care and Institute for Nutrition Research, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel.'}, {'ForeName': 'Pnina', 'Initials': 'P', 'LastName': 'Green', 'Affiliation': 'Laboratory of Nutrition and Metabolism Research, Felsenstein Medical Research Center, Sackler Faculty of Medicine, Tel Aviv University, Rabin Medical Center-Beilinson Campus, Petah Tikva, Israel.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Singer', 'Affiliation': 'Department of Intensive Care and Institute for Nutrition Research, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.2025']
3137,31394914,Polysomnographic Endotyping to Select Patients with Obstructive Sleep Apnea for Oral Appliances.,"Rationale: Oral appliance therapy is efficacious in many patients with obstructive sleep apnea (OSA), but prediction of treatment outcome is challenging. Small, detailed physiological studies have identified key OSA endotypic traits (pharyngeal collapsibility and loop gain) as determinants of greater oral appliance efficacy. Objectives: We used a clinically applicable method to estimate OSA traits from routine polysomnography and identify an endotype-based subgroup of patients expected to show superior efficacy. Methods: In 93 patients (baseline apnea-hypopnea index [AHI], ≥20 events/h), we examined whether polysomnography-estimated OSA traits (pharyngeal: collapsibility and muscle compensation; nonpharyngeal: loop gain, arousal threshold, and ventilatory response to arousal) were associated with oral appliance efficacy (percentage reduction in AHI from baseline) and could predict responses to treatment. Multivariable regression (with interactions) defined endotype-based subgroups of ""predicted"" responders and nonresponders (based on 50% reduction in AHI). Treatment efficacy was compared between the predicted subgroups (with cross-validation). Results: Greater oral appliance efficacy was associated with favorable nonpharyngeal traits (lower loop gain, higher arousal threshold, and lower response to arousal), moderate (nonmild, nonsevere) pharyngeal collapsibility, and weaker muscle compensation (overall R 2 = 0.30; adjusted R 2 = 0.19; P = 0.003). Predicted responders ( n = 54), compared with predicted nonresponders ( n = 39), exhibited a greater reduction in AHI from baseline (mean [95% confidence interval], 73% [66-79] vs. 51% [38-61]; P < 0.0001) and a lower treatment AHI (8 [6-11] vs. 16 [12-20] events/h; P = 0.002). Differences persisted after adjusting for clinical covariates (including baseline AHI, body mass index, and neck circumference). Conclusions: Quantifying OSA traits using clinical polysomnography can identify an endotype-based subgroup of patients that is highly responsive to oral appliance therapy. Prospective validation is warranted.",2019,"Greater oral appliance efficacy was associated with favorable nonpharyngeal traits (lower loop gain, higher arousal threshold, and lower response to arousal), moderate (nonmild, nonsevere) pharyngeal collapsibility, and weaker muscle compensation (overall R 2 = 0.30; adjusted R 2 = 0.19; P = 0.003).","['93 patients (baseline apnea-hypopnea index [AHI], ≥20 events/h', 'many patients with obstructive sleep apnea (OSA', 'Patients with Obstructive Sleep Apnea for Oral Appliances']",['Oral appliance therapy'],"['Greater oral appliance efficacy', 'Treatment efficacy', 'favorable nonpharyngeal traits (lower loop gain, higher arousal threshold, and lower response to arousal), moderate (nonmild, nonsevere) pharyngeal collapsibility, and weaker muscle compensation', 'polysomnography-estimated OSA traits (pharyngeal: collapsibility and muscle compensation; nonpharyngeal: loop gain, arousal threshold, and ventilatory response to arousal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",,0.03276,"Greater oral appliance efficacy was associated with favorable nonpharyngeal traits (lower loop gain, higher arousal threshold, and lower response to arousal), moderate (nonmild, nonsevere) pharyngeal collapsibility, and weaker muscle compensation (overall R 2 = 0.30; adjusted R 2 = 0.19; P = 0.003).","[{'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': 'Bamagoos', 'Affiliation': 'Sleep Research Group, Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Cistulli', 'Affiliation': 'Sleep Research Group, Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Sutherland', 'Affiliation': 'Sleep Research Group, Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Madronio', 'Affiliation': 'Centre for Sleep Health and Research, Department of Respiratory and Sleep Medicine, Royal North Shore Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Eckert', 'Affiliation': 'Sleep and Breathing Lab, Neuroscience Research Australia (NeuRA), Randwick, New South Wales, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hess', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Edwards', 'Affiliation': 'Sleep and Circadian Medicine Laboratory, Department of Physiology, and.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wellman', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201903-190OC']
3138,33038022,The effects of a brief hope intervention on decision-making in chronic kidney disease patients: A study protocol for a randomized controlled trial.,"AIMS
This study describes the study protocol of a manualized brief hope intervention that is based on the theoretical proposition - hope theory.
BACKGROUND
Patients with stage 5 chronic kidney disease often had decisional regret when facing the tension of treatment alternatives between dialysis initiation and palliative care. Hope has been found to account for therapeutic changes in clients with depressive symptoms, heightens positive expectations, and striving to accomplish chosen goals. Nevertheless, little is known about the effect of hope on decisional conflict and its influences to the quality of life in these chronic kidney disease patients.
DESIGN
This study is a single-blinded, randomized controlled trial.
METHODS
Participants will be recruited from a regional hospital (approved in April 2018). They will be randomly assigned in equal numbers to either the brief hope intervention or the control arm on completion of the baseline assessment on the possible need of dialysis initiation. Participants in the intervention group will receive the pre-dialysis education and a 4-week Brief Hope Intervention [consisting of four sessions at weekly intervals (two face-to-face sessions and two telephone follow-up sessions in between)], while those allocated to the control arm will receive the renal education and social chats. Outcome measures will be carried out prior to the intervention (baseline), immediately, and 1 month after the intervention. These consist of the hope level, decisional conflict, and quality of life. Healthcare resources use data will be reported.
IMPACT
The study results have the potential to add scientific evidence to the research-tested programme when developing renal services integral to multimodal care management to optimize decision-making and attain better health outcomes.",2020,"Hope has been found to account for therapeutic changes in clients with depressive symptoms, heightens positive expectations, and striving to accomplish chosen goals.","['chronic kidney disease patients', 'Patients with stage 5 chronic kidney disease often had decisional regret', 'Participants will be recruited from a regional hospital (approved in April 2018']","['pre-dialysis education', 'brief hope intervention', 'control arm will receive the renal education and social chats']",[],"[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2316810', 'cui_str': 'Chronic kidney disease stage 5'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}]",[],,0.0485543,"Hope has been found to account for therapeutic changes in clients with depressive symptoms, heightens positive expectations, and striving to accomplish chosen goals.","[{'ForeName': 'Kitty', 'Initials': 'K', 'LastName': 'Chan', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Suet Lai', 'Initials': 'SL', 'LastName': 'Tam', 'Affiliation': 'Department of Medicine and Geriatrics, Kwong Wah Hospital, Hong Kong, China.'}, {'ForeName': 'Ching Ping', 'Initials': 'CP', 'LastName': 'Kwok', 'Affiliation': 'Department of Medicine and Geriatrics, Kwong Wah Hospital, Hong Kong, China.'}, {'ForeName': 'Yuen Ping', 'Initials': 'YP', 'LastName': 'Fung', 'Affiliation': 'Department of Medicine and Geriatrics, Kwong Wah Hospital, Hong Kong, China.'}, {'ForeName': 'Ping Nam', 'Initials': 'PN', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Geriatrics, Kwong Wah Hospital, Hong Kong, China.'}]",Journal of advanced nursing,['10.1111/jan.14520']
3139,33038677,Rethink Vape: Development and evaluation of a risk communication campaign to prevent youth E-cigarette use.,"INTRODUCTION
E-cigarettes are now the most common form of tobacco use among adolescents, and use is associated with increased risk of initiation of cigarette smoking. This project used a community-engaged research process to develop and pilot a risk communication campaign to prevent youth vaping.
METHOD
The research team worked with a 36-member Teen Advisory Council and a 19-member Expert Panel. Together, the team employed survey (N = 674) and focus group (N = 82) methodologies, and hired a marketing company to partner on development of the campaign. Campaign concepts were developed, eliminated, and/or modified through an iterative process of feedback and refinement. The final campaign included video ads (https://bit.ly/2QMR8gH) a microsite (rethinkvape.org), and social media sites (@rethinkvape). The campaign communicated three messages to teens: what's in the vapor, health risks, and connections to big tobacco. Prior to launch of the campaign, a randomized controlled 2 (time) × 2 (group) online experiment was conducted to evaluate the campaign (N = 268).
RESULTS
Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change. Following evaluation, the team launched a 6-week online media campaign with a teen-targeted geo-fence radius to deliver 3,838,465 impressions, 770,443 completed video views, and 18,316 clicks in mobile app, Snapchat, YouTube, and Spotify platforms. The majority of placements exceeded industry standards, with mobile pre-roll and Snapchat as top performers.
CONCLUSIONS
The e-cigarette campaign showed promising signs of effectiveness and scalability.",2020,"RESULTS
Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change.",[],['Rethink Vape'],"['vaping knowledge, perceptions of risk, and anti-vape intentions', 'video ads (https://bit.ly/2QMR8gH) a microsite (rethinkvape.org), and social media sites (@rethinkvape']",[],"[{'cui': 'C0291011', 'cui_str': 'VAPE protocol'}]","[{'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",770443.0,0.0316952,"RESULTS
Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change.","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'England', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States. Electronic address: englankj@evms.edu.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Edwards', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Paulson', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Libby', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Harrell', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Mondejar', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106664']
3140,33038685,Intrinsic foot muscle strengthening exercises with electromyographic biofeedback achieve increased toe flexor strength in older adults: A pilot randomized controlled trial.,"BACKGROUND
Toe flexor strength is important for preventing older adults from falling. Although intrinsic foot muscles are the main determinants of toe flexor strength, exercises for strengthening these muscles are difficult for older adults. This study therefore aimed to determine whether the use of electromyographic biofeedback helps older adults to perform intrinsic foot muscle strengthening exercises.
METHODS
This randomized controlled trial had two parallel arms. Participants were randomly allocated to the control group or the electromyographic biofeedback group. Control participants performed two progressive intrinsic foot muscle strengthening exercises twice a week for 6 weeks. Participants in the other group performed these exercises assisted by electromyographic biofeedback. Primary outcome measures were changes in toe flexor strength and the timed up-and-go and functional reach tests (the latter two being balance tests).
FINDINGS
Altogether, 23 older adults were randomized to the control group (n = 12) or the electromyographic biofeedback group (n = 11). After the 6-week intervention, toe flexor strength on the dominant side increased in both groups (P < 0.017). However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5. There were no changes in the two balance tests. Three of the control group and two of the electromyographic biofeedback group were lost to follow- up.
INTERPRETATION
Our results indicate that, the use of electromyographic biofeedback can enhance the effect of intrinsic foot muscle strengthening exercises on the nondominant side in older adults.
CLINICAL TRIAL REGISTRATION NUMBER
UMIN000036521.",2020,"However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5.","['older adults', 'older adults from falling', '23 older adults']","['electromyographic biofeedback', 'exercises assisted by electromyographic biofeedback', 'progressive intrinsic foot muscle strengthening exercises', 'Intrinsic foot muscle strengthening exercises with electromyographic biofeedback', 'electromyographic biofeedback group']","['toe flexor strength on the nondominant side', 'toe flexor strength', 'changes in toe flexor strength and the timed up-and-go and functional reach tests (the latter two being balance tests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0204624', 'cui_str': 'Electromyographic biofeedback'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",23.0,0.0409907,"However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5.","[{'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Okamura', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: k-okamura@pu-hiroshima.ac.jp.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Egawa', 'Affiliation': 'Graduate School of Comprehensive Scientific Research, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan; Okii Clinic, 4-5-10 Motomachi, Iwakuni, Yamaguchi 740-0012, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Okii', 'Affiliation': 'Okii Clinic, 4-5-10 Motomachi, Iwakuni, Yamaguchi 740-0012, Japan.'}, {'ForeName': 'Sadaaki', 'Initials': 'S', 'LastName': 'Oki', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: oki@pu-hiroshima.ac.jp.'}, {'ForeName': 'Shusaku', 'Initials': 'S', 'LastName': 'Kanai', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: kanai@pu-hiroshima.ac.jp.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105187']
3141,33044684,Efficacy and Safety of ABP 798: Results from the JASMINE Trial in Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product.,"INTRODUCTION
ABP 798 is being developed as a biosimilar to rituximab reference product (RP), a CD20-directed cytolytic antibody that is approved in the US and EU for the treatment of non-Hodgkin lymphoma (NHL).
METHODS
This randomized, double-blind, comparative clinical study (JASMINE) evaluated the efficacy and safety of ABP 798 compared with rituximab RP. Adult, anti-CD20 treatment naïve patients diagnosed with grade 1, 2, or 3a follicular B-cell NHL expressing CD20 were randomized 1:1 to receive a 375 mg/m 2 infusion of either ABP 798 or rituximab RP once weekly for 4 weeks and at weeks 12 and 20. Tumor assessments were performed at baseline and weeks 12 and 28. Primary endpoint was the risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease.
RESULTS
Of the 256 randomized patients, 254 were treated with ABP 798 (n = 128; 100%) or rituximab RP (n = 126; 98.4%); 96 (78.0%) patients in the ABP 798 group and 87 (70.2%) in the rituximab RP group had a best ORR by week 28. The point estimate of RD in ORR between ABP 798 and rituximab RP from the adjusted generalized linear model for stratification factors was 7.7%. Clinical equivalence was based on sequential testing of the one-sided 95% lower confidence limits and one-sided 95% upper confidence limits of RD in ORR (- 1.4% and 16.8%, respectively) which was within the prespecified non-inferiority margin (- 15%) and non-superiority margin (35.5%), respectively. Results of sensitivity analyses were consistent with the primary efficacy analysis. ABP 798 was also comparable to rituximab RP across additional secondary endpoints, further supporting the conclusion of similarity, and including: RD of ORR at week 12; trough serum concentrations; percent of patients with complete depletion of CD19+ cell count at day 8; safety; and immunogenicity.
CONCLUSIONS
These results support a conclusion of similar clinical efficacy between ABP 798 and rituximab RP in patients with follicular lymphoma.
NCT NUMBER
NCT02747043; first posted April 21, 2016.
EUDRACT NUMBER
2013-005,542-11; submitted 14 October, 2014.",2020,"Primary endpoint was the risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease.
","['naïve patients diagnosed with grade 1, 2, or 3a follicular B-cell NHL expressing CD20', '256 randomized patients', 'patients with follicular lymphoma', 'Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product']","['ABP', 'ABP 798 or rituximab RP', 'rituximab RP', 'anti-CD20 treatment']","['efficacy and safety', 'Efficacy and Safety', 'risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1868944', 'cui_str': ""Follicular B-cell non-Hodgkin's lymphoma""}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0054946', 'cui_str': 'Lymphocyte antigen CD20'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0001239', 'cui_str': 'Actin-binding protein'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0054946', 'cui_str': 'Lymphocyte antigen CD20'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",256.0,0.112772,"Primary endpoint was the risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease.
","[{'ForeName': 'Dietger', 'Initials': 'D', 'LastName': 'Niederwieser', 'Affiliation': 'Division of Hematology and Oncology, University of Leipzig, Liebigstr. 19, 04106, Leipzig, Germany. Dietger.Niederwieser@medizin.uni-leipzig.de.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Schulich School of Medicine, Western University, Windsor, ON, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cobb', 'Affiliation': 'St. Vincent Frontier Cancer Center, Billings, MT, USA.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Cecily', 'Initials': 'C', 'LastName': 'Forsyth', 'Affiliation': 'Gosford Hospital, Gosford, NSW, Australia.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tucci', 'Affiliation': 'Hematology Department, ASST-Spedali Civili-Brescia, Brescia, Italy.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Hanes', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Delwail', 'Affiliation': 'Oncology-Hematology and Cell Therapy, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hajek', 'Affiliation': 'Department of Hematooncology, Faculty of Medicine, University Hospital Ostrava, University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Targeted oncology,['10.1007/s11523-020-00748-4']
3142,33040311,"The Effect of Low-Level Light Therapy on Capsaicin-Induced Peripheral and Central Sensitization in Healthy Volunteers: A Double-Blinded, Randomized, Sham-Controlled Trial.","INTRODUCTION
Several clinical trials have demonstrated that low-level light therapy (LLLT), a method of photobiomodulation, is an effective analgetic treatment. However, the mechanism of action has not yet been finally clarified. In particular, unanswered questions include whether it only affects peripheral or whether it also affects the spinal or supraspinal level. This study aimed to evaluate the effect of low-level light therapy on primary and secondary hyperalgesia in a human pain model.
METHODS
This study was planned as a randomized, sham-controlled, and double-blinded trial with repeated measures within subject design. Capsaicin was applied on both forearms of ten healthy volunteers to induce peripheral and central sensitization. One forearm was treated with low-level light therapy; the other served as sham control.
RESULTS
Low-level light therapy significantly increased the mechanical pain threshold, heat pain threshold, and decreased pain intensity.
CONCLUSIONS
Our data indicate that low-level light therapy is effective at reducing the heat and mechanical pain threshold in a human pain model, pointing to a significant modulating effect on peripheral and central sensitization. These effects-especially in the absence of reported side effects-make low-level light therapy a promising tool in pain management. The application of low-level light therapy to treat chronic pain should be considered for further clinical trials.",2020,"Our data indicate that low-level light therapy is effective at reducing the heat and mechanical pain threshold in a human pain model, pointing to a significant modulating effect on peripheral and central sensitization.","['ten healthy volunteers to induce peripheral and central sensitization', 'Healthy Volunteers']","['low-level light therapy', 'Capsaicin', 'Low-Level Light Therapy', 'low-level light therapy (LLLT']","['mechanical pain threshold, heat pain threshold, and decreased pain intensity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C0234252', 'cui_str': 'Mechanical pain'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",10.0,0.106331,"Our data indicate that low-level light therapy is effective at reducing the heat and mechanical pain threshold in a human pain model, pointing to a significant modulating effect on peripheral and central sensitization.","[{'ForeName': 'Kordula', 'Initials': 'K', 'LastName': 'Lang-Illievich', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Raimund', 'Initials': 'R', 'LastName': 'Winter', 'Affiliation': 'Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Rumpold-Seitlinger', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Schicho', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dorn', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Klivinyi', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Helmar', 'Initials': 'H', 'LastName': 'Bornemann-Cimenti', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria. helmar.bornemann@medunigraz.at.'}]",Pain and therapy,['10.1007/s40122-020-00205-0']
3143,33040439,A comparative study of 14-day dual therapy (esomeprazole and amoxicillin four times daily) and triple plus bismuth therapy for first-line Helicobacter pylori infection eradication: A randomized trial.,"BACKGROUND
Favorable outcomes in treating H pylori infection using ""dual therapy (proton pump inhibitor and amoxicillin four times daily)"" have attracted widespread attention. However, there are few reports, and the study results lack agreement. This study aimed to compare the eradication rate, safety, and compliance of naïve-treatment patients with H pylori infection on ""dual therapy"" with those on ""triple plus bismuth (TPB) therapy.""
METHODS
This is a non-inferior randomized controlled trial conducted on 760 patients with H pylori infection. The participants were randomly assigned to two eradication groups: dual therapy (esomeprazole 20 mg and amoxicillin 750 mg four times daily) and TPB therapy (esomeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth potassium citrate 220 mg twice daily) for 14 days. Safety and compliance were assessed within 3 days after eradication. Urea breath test was performed about 8 weeks after eradication to evaluate outcome. Antibiotic resistance and CYP2C19 polymorphism were determined.
RESULTS
Compared with TPB therapy, dual therapy had significantly higher eradication rates in intention-to-treat (87.1% vs 80.5%, rate difference 6.6%), modified intention-to-treat (90.9% vs 85.5%, 5.5%) and per-protocol (92.4% vs 87.8%, 4.7%) analyses, respectively. Adverse reactions in dual therapy group were significantly lower than TPB therapy group (17.6% vs 25.5%, P = .008), and dual therapy group had better compliance (96.3% vs 92.3%, P = .019). Antibiotic resistance and poor compliance were also associated with treatment failure.
CONCLUSIONS
Dual therapy (esomeprazole and amoxicillin four times daily) was non-inferior to, and even superior to TPB therapy as first-line H pylori eradication.",2020,"Compared with TPB therapy, dual therapy had significantly higher eradication rates in intention-to-treat (87.1% vs 80.5%, rate difference 6.6%), modified intention-to-treat (90.9% vs 85.5%, 5.5%) and per-protocol (92.4% vs 87.8%, 4.7%) analyses, respectively.","['naïve-treatment patients with H\xa0pylori infection on ""dual therapy"" with those on ""triple plus bismuth (TPB) therapy', 'first-line Helicobacter pylori infection eradication', '760 patients with H\xa0pylori infection']","['TPB therapy (esomeprazole 20\xa0mg, amoxicillin 1000\xa0mg, clarithromycin 500\xa0mg, and bismuth potassium citrate', 'triple plus bismuth therapy', 'TPB therapy, dual therapy', 'Dual therapy (esomeprazole and amoxicillin', 'dual therapy (proton pump inhibitor and amoxicillin', '14-day dual therapy (esomeprazole and amoxicillin', 'TPB therapy', 'dual therapy (esomeprazole 20\xa0mg and amoxicillin']","['modified intention-to-treat', 'eradication rates', 'Adverse reactions', 'Urea breath test', 'Antibiotic resistance and CYP2C19 polymorphism', 'eradication rate, safety, and compliance', 'Safety and compliance', 'Antibiotic resistance and poor compliance']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1146111', 'cui_str': 'Esomeprazole 20 MG'}, {'cui': 'C1126881', 'cui_str': 'Amoxicillin 1000 MG'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C0137996', 'cui_str': 'potassium citrate'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C3203672', 'cui_str': 'CYP2C19 polymorphism'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",760.0,0.0262944,"Compared with TPB therapy, dual therapy had significantly higher eradication rates in intention-to-treat (87.1% vs 80.5%, rate difference 6.6%), modified intention-to-treat (90.9% vs 85.5%, 5.5%) and per-protocol (92.4% vs 87.8%, 4.7%) analyses, respectively.","[{'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Baojun', 'Initials': 'B', 'LastName': 'Suo', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Zhanyue', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}]",Helicobacter,['10.1111/hel.12762']
3144,33045536,Laser tongue debridement for oral malodor-A novel approach to halitosis.,"STUDY OBJECTIVE
Malodor is a multifactorial condition with oral pathology representing the main culprit and the tongue being the first to second contributor to the malodor. Bacterial load can represent a quantifiable measure regardless of the original pathology. We hypothesize that reduction in malodor can be represented by tongue changes both in appearance, bacterial and biofilm load reduction (measured by CFU and volatile gases measurement), organoleptic measurement and subjective improvement.
METHODS
A randomized controlled prospective study under IRB approval. Diagnostic criteria for enrollment and follow up were organoleptic test by 2 judges, Halimeter reading, tongue colors changes HALT questionnaire and direct aerobic and anaerobic tongue cultures measured by CFU. Patients were treated with laser tongue debridement (LTD) with an Er,Cr:YSGG solid state laser has been shown to be effective in biofilm reduction.
RESULTS
54 patients recruited with 35 available for follow up. Improvement was observed on all objective and QOL subjective parameters. Treatment was tolerated well with minimal discomfort.
CONCLUSIONS
The tongue is proven to be a major contributor to oral malodor and must be addressed in treatment protocol. LTD significantly reduces malodor by subjective and objective criteria. While impossible to determine whether the tongue serves as a bacterial reservoir or is the origin for oral bacteria it is clear that LTD improves oral hygiene and reduces malodor. LTD is safe and easy to perform. We encourage LTD to be a crucial part of any oral malodor treatment protocol.
TRIAL REGISTRATION
clinical trials, NCT04120948. Registered 25 September 2019 - Retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00098SX&selectaction=Edit&uid=U0000W0Y&ts=51&cx=-elnx7e.",2020,Improvement was observed on all objective and QOL subjective parameters.,"['Registered 25 September 2019 - Retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00098SX&selectaction=Edit&uid=U0000W0Y&ts=51&cx=-elnx7e', '54 patients recruited with 35 available for follow up']","['laser tongue debridement (LTD) with an Er,Cr:YSGG solid state laser', 'LTD', 'Laser tongue debridement for oral malodor']","['objective and QOL subjective parameters', 'oral hygiene and reduces malodor']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1839730', 'cui_str': 'Prieto X-linked mental retardation syndrome'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C1289836', 'cui_str': 'Solid-state laser device'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",54.0,0.0383094,Improvement was observed on all objective and QOL subjective parameters.,"[{'ForeName': 'Yosef P', 'Initials': 'YP', 'LastName': 'Krespi', 'Affiliation': 'Northwell Health, United States of America. Electronic address: ykrespi1@northwell.edu.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Kizhner', 'Affiliation': ""Mount Sinai St. Luke's, United States of America.""}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Wilson', 'Affiliation': 'Northwell Health, United States of America.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Sivriver', 'Affiliation': 'Biolase, Irvine, CA, United States of America.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Low', 'Affiliation': 'Biolase, Irvine, CA, United States of America.'}, {'ForeName': 'Yalda', 'Initials': 'Y', 'LastName': 'Khosravi', 'Affiliation': 'Ohio State University, Campus Microscopy and Imaging Facility, Departments of Microbial Infection and Immunity and Orthopaedics, Infectious Diseases Institute, United States of America.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stoodley', 'Affiliation': 'Ohio State University, Campus Microscopy and Imaging Facility, Departments of Microbial Infection and Immunity and Orthopaedics, Infectious Diseases Institute, United States of America.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102458']
3145,33045675,"A pilot study of the effects of chromium picolinate supplementation on serum fetuin-A, metabolic and inflammatory factors in patients with nonalcoholic fatty liver disease: A double-blind, placebo-controlled trial.","BACKGROUND
Evaluating the impact of chromium picolinate supplementation on glycemic status, lipid profile, inflammatory markers and fetuin-A in patients with non-alcoholic fatty liver disease (NAFLD).
METHODS
In present research, participants (N = 46) were randomized to (400 mcg/day, n = 23) chromium picolinate and placebo (n = 23) for 3 months.
RESULTS
Glucose indices, and lipid profiles, inflammatory biomarker and fetuin-A were measured before and after the intervention. Chromium reduced triglyceride (TG), atherogenic index of plasma (AIP), very-low-density lipoprotein (VLDL), insulin, homeostatic model assessment for insulin resistance (HOMA-IR), high-sensitivity C-reactive protein (hs-CRP), interleukin (IL) -6, tumor necrosis factor-alpha (TNF-α) and fetuin-A significantly compared to placebo group (p < 0.05). Furthermore, chromium significantly increased the quantitative insulin sensitivity check index (QUICKI). There were no significant differences in total cholesterol (TC), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), fasting blood sugar (FBS), Hemoglobin A1c (HbA1C), interleukin (IL)-17 between the two groups (p < 0.05).
CONCLUSION
Chromium picolinate significantly decreased TG, insulin, HOMA-IR, fetuin-A, the number of inflammatory factors, and increased QUICKI without changing FBS, HbA1C, TC, LDL, HDL, IL-17 levels and liver steatosis intensity in patients with NAFLD. Further studies by examining the effect of different doses of chromium and mechanisms of cellular action, would help further clarify the subject.",2020,"Furthermore, chromium significantly increased the quantitative insulin sensitivity check index (QUICKI).","['patients with NAFLD', 'patients with nonalcoholic fatty liver disease', 'participants (N\u202f=\u202f46', 'patients with non-alcoholic fatty liver disease (NAFLD']","['chromium picolinate and placebo', 'chromium picolinate supplementation', 'placebo', 'Chromium picolinate']","['serum fetuin-A, metabolic and inflammatory factors', 'Chromium reduced triglyceride (TG), atherogenic index of plasma (AIP), very-low-density lipoprotein (VLDL), insulin, homeostatic model assessment for insulin resistance (HOMA-IR), high-sensitivity C-reactive protein (hs-CRP), interleukin (IL) -6, tumor necrosis factor-alpha (TNF-α) and fetuin-A', 'quantitative insulin sensitivity check index (QUICKI', 'Glucose indices, and lipid profiles, inflammatory biomarker and fetuin-A', 'total cholesterol (TC), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), fasting blood sugar (FBS), Hemoglobin A1c (HbA1C), interleukin (IL)-17', 'glycemic status, lipid profile, inflammatory markers', 'TG, insulin, HOMA-IR, fetuin-A, the number of inflammatory factors, and increased QUICKI without changing FBS, HbA1C, TC, LDL, HDL, IL-17 levels and liver steatosis intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0163657', 'cui_str': 'CHROMIUM PICOLINATE'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C3160817', 'cui_str': 'Serum fetuin-A'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0051477', 'cui_str': 'Alpha>2< hS glycoprotein'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",46.0,0.22934,"Furthermore, chromium significantly increased the quantitative insulin sensitivity check index (QUICKI).","[{'ForeName': 'Fardin', 'Initials': 'F', 'LastName': 'Moradi', 'Affiliation': 'Student Research Committee, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran; Nutrition Research Center, Department of Biochemistry & Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Science, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Kooshki', 'Affiliation': 'Student Research Committee, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran; Nutrition Research Center, Department of Biochemistry & Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Science, Iran.'}, {'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Nokhostin', 'Affiliation': 'Assistant Professor of Internal Medicine, Dept. of Internal Medicine, Faculty of Medicine, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Manouchehr', 'Initials': 'M', 'LastName': 'Khoshbaten', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Bazyar', 'Affiliation': 'Student Research Committee, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Pourghassem Gargari', 'Affiliation': 'Nutrition Research Center, Department of Biochemistry & Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Science, Iran. Electronic address: pourghassemb@tbzmed.ac.ir.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126659']
3146,33047340,A controlled trial of dissemination and implementation of a cardiovascular risk reduction strategy in small primary care practices.,"OBJECTIVE
To assess the effect of dissemination and implementation of an intervention consisting of practice facilitation and a risk-stratified, population management dashboard on cardiovascular risk reduction for patients at high risk in small, primary care practices.
STUDY SETTING
A total of 219 small primary care practices (≤10 clinicians per site) across North Carolina with primary data collection from electronic health records (EHRs) from the fourth quarter of 2015 through the second quarter of 2018.
STUDY DESIGN
We performed a stepped-wedge, stratified, cluster randomized trial of a one-year intervention consisting of practice facilitation utilizing quality improvement techniques coupled with a cardiovascular dashboard that included lists of risk-stratified adults, aged 40-79 years and their unmet treatment opportunities. The primary outcome was change in 10-Year ASCVD Risk score among all patients with a baseline score ≥10 percent from baseline to 3 months postintervention.
DATA COLLECTION/ EXTRACTION METHODS
Data extracts were securely transferred from practices on a nightly basis from their EHR to the research team registry.
PRINCIPLE FINDINGS
ASCVD risk scores were assessed on 437 556 patients and 146 826 had a calculated 10-year risk ≥10 percent. The mean baseline risk was 23.4 percent (SD ± 12.6 percent). Postintervention, the absolute risk reduction was 6.3 percent (95% CI 6.3, 6.4). Models considering calendar time and stepped-wedge controls revealed most of the improvement (4.0 of 6.3 percent) was attributable to the intervention and not secular trends. In multivariate analysis, male gender, age >65 years, low-income (<$40 000), and Black race (P < .001 for all variables) were each associated with greater risk reductions.
CONCLUSION
A risk-stratified, population management dashboard combined with practice facilitation led to substantial reductions of 10-year ASCVD risk for patients at high risk. Similar approaches could lead to effective dissemination and implementation of other new evidence, especially in rural and other under-resourced practices. Registration: ClinicalTrials.Gov 15-0479.",2020,"Postintervention, the absolute risk reduction was 6.3 percent (95% CI 6.3, 6.4).","['with a cardiovascular dashboard that included lists of risk-stratified adults, aged 40-79\xa0years and their unmet treatment opportunities', 'Data extracts were securely transferred from practices on a nightly basis from their EHR to the research team registry', 'patients at high risk', 'ASCVD risk scores were assessed on 437\xa0556 patients and 146\xa0826 had a calculated 10-year risk ≥10 percent', 'small primary care practices', 'A total of 219 small primary care practices (≤10 clinicians per site) across North Carolina with primary data collection from electronic health records (EHRs) from the fourth quarter of 2015 through the second quarter of 2018', 'patients at high risk in small, primary care practices']",['practice facilitation utilizing quality improvement techniques coupled'],"['mean baseline risk', '10-Year ASCVD Risk score', 'cardiovascular risk reduction', '10-year ASCVD risk', 'absolute risk reduction']","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517811', 'cui_str': '556'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",437556.0,0.317543,"Postintervention, the absolute risk reduction was 6.3 percent (95% CI 6.3, 6.4).","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Cykert', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Keyserling', 'Affiliation': 'Division of General Internal Medicine and Clinical Epidemiology, The University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pignone', 'Affiliation': 'Department of Internal Medicine, The Dell Medical School, University of Texas, Austin, Texas, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'DeWalt', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Weiner', 'Affiliation': 'Department of Global Public Health, School of Public Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Justin G', 'Initials': 'JG', 'LastName': 'Trogdon', 'Affiliation': 'Department of Health Policy and Management, The Gillings School of Global Public Health, The University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wroth', 'Affiliation': 'Community Care of North Carolina, Raleigh, North Carolina, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Halladay', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Mackey', 'Affiliation': 'The North Carolina Area Health Education Centers Program, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fine', 'Affiliation': 'Department of Biostatistics, The Gillings School of Global Public Health, The University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jung', 'Initials': 'J', 'LastName': 'In Kim', 'Affiliation': 'Department of Statistics, Eberly College of Science, The Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cene', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Health services research,['10.1111/1475-6773.13571']
3147,33050947,An adaptive randomised placebo controlled phase II trial of antivirals for COVID-19 infection (VIRCO): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES
Primary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisation Secondary objectives: • To determine the safety of the antiviral • To determine the clinical benefit of the antiviral over placebo according to the WHO 7-point ordinal scale • To determine the clinical benefit of the antiviral over placebo on time to resolution of clinical symptoms • To determine the effect of the antiviral over placebo on biomarkers of inflammation and immune activation TRIAL DESIGN: This is a multi-centre, triple-blind, randomised placebo controlled phase II, 2-arm trial with parallel-group design with allocation ratio 1:1.
PARTICIPANTS
Inclusion Criteria: • Provision of informed consent by the participant • Age ≥18 years • Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days • COVID-19 related symptom initiation within 5 days • Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment.
EXCLUSION CRITERIA
• Known allergy to the study medication • Is on another clinical trial investigating an antiviral treatment for COVID-19 • Pregnancy • Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification • Patients with renal impairment requiring dialysis • Is deemed by the Investigator to be ineligible for any reason Participants will be recruited from, and the study visits will take place at Alfred Hospital, Monash Health, Austin Health in Victoria, Australia for hospitalised participants as well as recruitment in the community in participants homes for eligible people not requiring hospitalisation.
INTERVENTION AND COMPARATOR
The first candidate antiviral is favipiravir Arm 1: Favipiravir 1800 mg favipiravir BD on Day 1 followed by 800 mg BD favipiravir for the next 13 days. Arm 2: Placebo MAIN OUTCOMES: Primary outcome: Time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing during the 14 days after enrolment.
RANDOMISATION
Randomisation performed at the Alfred Hospital Clinical Trials Pharmacy using computer generated block-randomisation lists with 6 participants per block. Within each block half of the participants will be randomised to the candidate antiviral and the other half to placebo. Randomisation is stratified by study site, with participants enrolled in the community considered as a study site.
BLINDING (MASKING)
Study participants, study investigators and the study statistician will be blinded to treatment allocation.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir TRIAL STATUS: Protocol version 2.0 Dated 31-Jul-2020. Recruitment will take place between July 2020 and December 2020.
TRIAL REGISTRATION
clinicaltrials.gov NCT04445467 First posted 24-Jun-2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir TRIAL STATUS:,"['COVID-19 infection (VIRCO', 'Inclusion Criteria: • Provision of informed consent by the participant • Age ≥18 years •', 'participants homes for eligible people not requiring hospitalisation', '190 people (95/arm) with the first candidate antiviral favipiravir TRIAL STATUS', 'Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential', 'COVID-19 • Pregnancy • Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification •', 'participants enrolled in the community considered as a study site', 'Patients with renal impairment requiring dialysis •', 'Female patients of childbearing potential']","['antiviral •', '24-Jun-2020', 'placebo', 'Placebo', 'Favipiravir 1800 mg favipiravir BD']","['WHO 7-point ordinal scale •', 'Time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0441807', 'cui_str': 'Grade C'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0162508', 'cui_str': 'jun Oncogene'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}]","[{'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0200932', 'cui_str': 'Nucleic acid amplification'}]",,0.508829,The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir TRIAL STATUS:,"[{'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'McMahon', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia. james.mcmahon@monash.edu.'}, {'ForeName': 'Jillian S Y', 'Initials': 'JSY', 'LastName': 'Lau', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Roney', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Rogers', 'Affiliation': 'Department of Infectious Diseases, Monash Medical Centre, Melbourne, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Trubiano', 'Affiliation': 'Department of Infectious Diseases, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sasadeusz', 'Affiliation': 'Department of Infectious Diseases, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Molton', 'Affiliation': 'Department of Infectious Diseases, Western Health, Melbourne, Australia.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Gardiner', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Sue J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Hoy', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Anton Y', 'Initials': 'AY', 'LastName': 'Peleg', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia.'}]",Trials,['10.1186/s13063-020-04766-5']
3148,33049424,The impact of prior and ongoing threat on the false alarm threshold for facial discrimination.,"BACKGROUND AND OBJECTIVES
Perceptual adaptations that facilitate rapid responses to threats can also lead to false alarms, or the failure to discriminate safe stimuli from signals of threat. We examined the impact of varying degrees of threat on false alarms in the perceptual discrimination of faces along the dimension of emotion (Experiment 1) or identity (Experiment 2).
METHODS
Participants first trained to discriminate between a target and nontarget face. Next, we tested their ability to identify the target in randomized presentations of the target, the nontarget, and nine novel stimuli morphed in 10% increments of similarity from the target to the nontarget. The task was completed under one of three randomized conditions: 1) Ongoing-Threat paired the target with an aversive outcome in both phases; 2) Prior-Threat paired the target with an aversive outcome in the training phase only; and 3) No-Threat paired the target with a neutral outcome in the training phase only.
RESULTS
In Experiment 1 (N = 90), Ongoing-Threat lowered the false alarm threshold for facial discrimination based on anger intensity compared to Prior-Threat and No-Threat. In Experiment 2 (N = 90), Ongoing-Threat and Prior-Threat each lowered the false alarm threshold for identity-based discrimination compared to No-Threat.
LIMITATIONS
The experiment did not measure generalization of threat responses.
CONCLUSION
Associating a facial expression or identity with threat leads to faster but less accurate discrimination of faces with similar features, particularly under conditions of ongoing threat. These experiments provide an avenue for examining the parameters that impact false alarms, which play a key role in anxiety disorders.",2020,"In Experiment 1 (N = 90), Ongoing-Threat lowered the false alarm threshold for facial discrimination based on anger intensity compared to Prior-Threat and No-Threat.",['Participants first trained to discriminate between a target and nontarget face'],[],[],"[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205235', 'cui_str': 'Discriminate'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",[],[],,0.0222255,"In Experiment 1 (N = 90), Ongoing-Threat lowered the false alarm threshold for facial discrimination based on anger intensity compared to Prior-Threat and No-Threat.","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Papini', 'Affiliation': 'The University of Texas at Austin, USA. Electronic address: spapini@utexas.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Dunsmoor', 'Affiliation': 'The University of Texas at Austin, USA.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'The University of Texas at Austin, USA.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101619']
3149,33049433,Selecting the optimal treatment for a depressed individual: Clinical judgment or statistical prediction?,"BACKGROUND
Optimizing treatment selection is a way to enhance treatment success in major depressive disorder (MDD). In clinical practice, treatment selection heavily depends on clinical judgment. However, research has consistently shown that statistical prediction is as accurate - or more accurate - than predictions based on clinical judgment. In the context of new technological developments, the current aim was to compare the accuracy of clinical judgment versus statistical predictions in selecting cognitive therapy (CT) or interpersonal psychotherapy (IPT) for MDD.
METHODS
Data came from a randomized trial comparing CT (n=76) with IPT (n=75) for MDD. Prior to randomization, therapists' recommendations were formulated during multidisciplinary staff meetings. Statistical predictions were based on Personalized Advantage Index models. Primary outcomes were post-treatment and 17-month follow-up depression severity. Secondary outcome was treatment dropout.
RESULTS
Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment. This difference was not found for recommended versus non-recommended treatments based on clinical judgment. Moreover, for individuals with an IPT recommendation by therapists, higher post-treatment and follow-up depression severity was found for those that actually received IPT compared to those that received CT. Recommendations based on statistical prediction and clinical judgment were not associated with differences in treatment dropout.
LIMITATIONS
Information on the clinical reasoning behind therapist recommendations was not collected, and statistical predictions were not externally validated.
CONCLUSIONS
Statistical prediction outperforms clinical judgment in treatment selection for MDD and has the potential to personalize treatment strategies.",2020,"RESULTS
Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment.","['n=76) with IPT (n=75) for MDD', 'major depressive disorder (MDD']","['CT', 'IPT', 'cognitive therapy (CT) or interpersonal psychotherapy (IPT']","['treatment dropout', 'post-treatment and 17-month follow-up depression severity']","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}]","[{'cui': 'C0030686', 'cui_str': 'Patient Dropouts'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",76.0,0.0177431,"RESULTS
Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment.","[{'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'van Bronswijk', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands. Electronic address: suzanne.vanbronswijk@maastrichtuniversity.nl.'}, {'ForeName': 'Lotte H J M', 'Initials': 'LHJM', 'LastName': 'Lemmens', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands.'}, {'ForeName': 'Marcus J H', 'Initials': 'MJH', 'LastName': 'Huibers', 'Affiliation': 'Department of Clinical Psychology, VU University Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam, the Netherlands; Department of Psychology, University of Pennsylvania, 3720 Walnut Street, Philadelphia, PA 19104-6241, USA.'}, {'ForeName': 'Frenk P M L', 'Initials': 'FPML', 'LastName': 'Peeters', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.135']
3150,33049434,Acute Effects of Cannabis on Symptoms of Obsessive-Compulsive Disorder.,"BACKGROUND
Little is known about the the acute effects of cannabis on symptoms of OCD in humans. Therefore, this study sought to: 1) examine whether symptoms of OCD are significantly reduced after inhaling cannabis, 2) examine predictors (gender, dose, cannabis constituents, time) of these symptom changes and 3) explore potential long-term consequences of repeatedly using cannabis to self-medicate for OCD symptoms, including changes in dose and baseline symptom severity over time.
METHOD
Data were analyzed from the app Strainprint® which provides medical cannabis patients a means of tracking changes in symptoms as a function of different doses and strains of cannabis across time. Specifically, data were analyzed from 87 individuals self-identifying with OCD who tracked the severity of their intrusions, compulsions, and/or anxiety immediately before and after 1,810 cannabis use sessions spanning a period of 31 months.
RESULTS
Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis. Higher concentrations of CBD and higher doses predicted larger reductions in compulsions. The number of cannabis use sessions across time predicted changes in intrusions, such that later cannabis use sessions were associated with smaller reductions in intrusions. Baseline symptom severity and dose remained fairly constant over time.
LIMITATIONS
The sample was self-selected, self-identified as having OCD, and there was no placebo control group.
CONCLUSIONS
Inhaled cannabis appears to have short-term beneficial effects on symptoms of OCD. However, tolerance to the effects on intrusions may develop over time.",2020,"RESULTS
Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis.","['87 individuals self-identifying with OCD who tracked the severity of their intrusions, compulsions, and/or anxiety immediately before and after 1,810 cannabis use sessions spanning a period of 31 months', 'Data were analyzed from the app Strainprint® which provides medical cannabis patients a means of tracking changes in symptoms as a function of different doses and strains of cannabis across time']",['Cannabis'],"['Symptoms of Obsessive-Compulsive Disorder', 'anxiety', 'compulsions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0813973', 'cui_str': 'Medical Cannabis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}]",,0.034413,"RESULTS
Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis.","[{'ForeName': 'Dakota', 'Initials': 'D', 'LastName': 'Mauzay', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'LaFrance', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Cuttler', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US. Electronic address: carrie.cuttler@wsu.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.124']
3151,33032180,A prospective randomized controlled trial on the value of prophylactic oral nutritional supplementation in locally advanced nasopharyngeal carcinoma patients receiving chemo-radiotherapy.,"OBJECTIVES
We investigated the effect of prophylactic oral nutrition supplements (ONS) in locally advanced nasopharyngeal carcinoma patients receiving neoadjuvant chemotherapy and concurrent chemoradiotherapy (CCRT).
METHODS
Eligible patients were randomly assigned to an intervention or control group. Patients in the intervention group were supported with prophylactic ONS from the beginning of CCRT. The control group received nutritional support only when necessary. Bodyweight, hematological indexes, nutritional status, and quality of life were measured at baseline and before, during, and after RT.
RESULTS
We evaluated 114 patients from October 2016 to May 2018. More than half of patients experienced significant weight loss during CCRT, which continued for three months after radiotherapy (RT). Compared to baseline, the rate of weight loss ≥ 5% before, during, at the end of RT, and one and three months after RT were 3.5%, 28.9%, 51.8%, 61.4%, and 61.4%, respectively. Nutritional status and global health status scores progressively decreased during treatment. The rate of RT interruption was higher in the control group than in the intervention group (7.14% vs. 0%, χ 2 = 4.29, P = 0.04). More patients experienced concurrent chemotherapy interruption in the control group than in the intervention group (28.57% vs 10.34%, χ 2 = 6.08, P = 0.01). There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
CONCLUSIONS
Malnutrition and weight loss progressively increased during treatment. Prophylactic ONS can improve tolerance to CCRT, but it offers no advantage on short-term weight loss or nutritional assessment scores.",2020,"There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
","['locally advanced nasopharyngeal carcinoma patients receiving', 'Eligible patients', 'locally advanced nasopharyngeal carcinoma patients receiving neoadjuvant chemotherapy and concurrent chemoradiotherapy (CCRT', '114 patients from October 2016 to May 2018']","['Prophylactic ONS', 'prophylactic oral nutrition supplements (ONS', 'chemo-radiotherapy', 'prophylactic ONS', 'nutritional support', 'prophylactic oral nutritional supplementation']","['weight loss', 'Nutritional status and global health status scores', 'concurrent chemotherapy interruption', 'rate of weight loss', 'rate of RT interruption', 'Bodyweight, hematological indexes, nutritional status, and quality of life', 'weight loss, nutritional status, quality of life, and global health status']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",114.0,0.0467853,"There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China. Electronic address: huangshuang@zjcc.org.cn.'}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Piao', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Caineng', 'Initials': 'C', 'LastName': 'Cao', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Hangzhou YITU Healthcare Technology Co., Ltd, Xihu District, Hangzhou 310012, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sheng', 'Affiliation': 'Hangzhou YITU Healthcare Technology Co., Ltd, Xihu District, Hangzhou 310012, China.'}, {'ForeName': 'Zekai', 'Initials': 'Z', 'LastName': 'Shu', 'Affiliation': 'The 2nd Clinical Medical College of Zhejiang, Chinese Medical University, No. 534, Binwen Road, Hangzhou 310053, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Hua', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Qiaoying', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China. Electronic address: chenyy@zjcc.org.cn.'}]",Oral oncology,['10.1016/j.oraloncology.2020.105025']
3152,33032256,Effects of familial Mediterranean fever on the middle ear.,"OBJECTIVE
To evaluate middle and inner ear function and hearing status of children with familial Mediterranean fever (FMF).
METHODS
We assigned 56 patients with FMF to the study group and 52 healthy volunteers to the control group. The mean age of patients in the study and control groups were 10.10 ± 3.70 and 9.77 ± 3.74 years, respectively. Physical examination and hearing evaluation were performed in both groups. The audiological test battery included 226-Hz tympanometry, pure tone audiometric evaluation, acoustic stapedial reflex measurements, distortion product otoacoustic emission recording, and wide-band tympanometry assessment.
RESULTS
The groups were similar in age and sex ratio (p > 0.05 for both comparisons). Pure tone audiogram and distortion product otoacoustic emission results were also similar for both groups (p > 0.05). The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram. The contralateral acoustic stapedial reflex thresholds were significantly higher in the familial Mediterranean fever group (p < 0.05 for all comparisons). The ambient and peak pressure absorbance values of wide-band tympanometry were significantly lower at 2000 Hz and significantly higher at 4000 Hz in the familial Mediterranean fever group (p < 0.05 for both comparisons). The severity and duration of disease adversely affected the absorbance values of wide-band tympanometry at 2000 and 4000 Hz (p < 0.05).
CONCLUSION
To our knowledge, this is the first study to demonstrate the adverse subclinical effects of familial Mediterranean fever on the middle ear. We recommend that children diagnosed with FMF should be closely monitored for future clinical middle ear pathologies.",2020,The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram.,"['56 patients with FMF to the study group and 52 healthy volunteers to the control group', 'familial Mediterranean fever on the middle ear', 'children with familial Mediterranean fever (FMF', 'children diagnosed with FMF']",[],"['contralateral acoustic stapedial reflex thresholds', 'ambient and peak pressure absorbance values of wide-band tympanometry', '226-Hz tympanometry, pure tone audiometric evaluation, acoustic stapedial reflex measurements, distortion product otoacoustic emission recording, and wide-band tympanometry assessment', 'absorbance values of wide-band tympanometry', 'Physical examination and hearing evaluation', 'ipsilateral acoustic stapedial reflex']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031069', 'cui_str': 'Familial Mediterranean fever'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",[],"[{'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0428765', 'cui_str': 'Stapedial reflex threshold'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C1268822', 'cui_str': 'Optical density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0085853', 'cui_str': 'Tympanometry testing'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034934', 'cui_str': 'Stapedial reflex'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0162525', 'cui_str': 'Spontaneous Otoacoustic Emissions'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}]",56.0,0.0334702,The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram.,"[{'ForeName': 'Asli Cakir', 'Initials': 'AC', 'LastName': 'Cetin', 'Affiliation': 'Department of Otorhinolaryngology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: asli.cakir@deu.edu.tr.'}, {'ForeName': 'Ceyhun', 'Initials': 'C', 'LastName': 'Acari', 'Affiliation': 'Department of Pediatrics, Section of Immunology and Rheumatology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: ceyhun.acari@deu.edu.tr.'}, {'ForeName': 'Hande', 'Initials': 'H', 'LastName': 'Evin', 'Affiliation': 'Department of Otorhinolaryngology, Unit of Speech, Hearing & Balance, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: handeevin1@gmail.com.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Omer Ikiz', 'Affiliation': 'Department of Otorhinolaryngology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: ahmet.ikiz@deu.edu.tr.'}, {'ForeName': 'Gunay', 'Initials': 'G', 'LastName': 'Kirkim', 'Affiliation': 'Department of Otorhinolaryngology, Unit of Speech, Hearing & Balance, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: gunay.kirkim@deu.edu.tr.'}, {'ForeName': 'Erbil', 'Initials': 'E', 'LastName': 'Unsal', 'Affiliation': 'Department of Pediatrics, Section of Immunology and Rheumatology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: erbil.unsal@deu.edu.tr.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110417']
3153,33034900,Local cooling for relieving pain from perineal trauma sustained during childbirth.,"BACKGROUND
Perineal trauma is common during childbirth and may be painful. Contemporary maternity practice includes offering women numerous forms of pain relief, including the local application of cooling treatments. This Cochrane Review is an update of a review last updated in 2012.
OBJECTIVES
To evaluate the effectiveness of localised cooling treatments compared with no treatment, placebo, or other cooling treatments applied to the perineum for pain relief following perineal trauma sustained during childbirth.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (7 October 2019) and reference lists of retrieved studies.
SELECTION CRITERIA
Published and unpublished randomised and quasi-randomised trials (RCTs) that compared a localised cooling treatment applied to the perineum with no treatment, placebo, or another cooling treatment applied to relieve pain related to perineal trauma sustained during childbirth.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies. Data were double checked for accuracy. The certainty of the evidence was assessed using the GRADE approach.
MAIN RESULTS
We included 10 RCTs that enrolled 1233 women randomised to the use of one cooling treatment (ice, cold gel pad, cooling plus compression, cooling plus compression plus (being) horizontal) compared with another cooling treatment, no treatment, or placebo (water pack, compression). The included trials were at low or uncertain risk of bias overall, with the exception that the inability to blind participants and personnel to group allocation meant that we rated all trials at unclear or high risk for this domain. We undertook a number of comparisons to evaluate the different treatments. Cooling treatment (ice pack or cold gel pad) versus no treatment There was limited very low-certainty evidence that cooling treatment may reduce women's self-reported perineal pain within four to six hours (mean difference (MD) -4.46, 95% confidence interval (CI) -5.07 to -3.85 on a 10-point scale; 1 study, 100 participants) or between 24 and 48 hours of giving birth (risk ratio (RR) 0.73, 95% CI 0.57 to 0.94; 1 study, 316 participants). The evidence is very uncertain about the various measures of wound healing, for example, wound edges gaping when inspected five days after giving birth (RR 2.56, 95% CI 0.58 to 11.33; 1 study, 315 participants). Women generally rated their satisfaction with perineal care similarly following cooling or no treatment. The potential exception was that there may be a trivially lower mean difference of -0.1 on a five-point scale of psychospiritual comfort with cooling treatment, that is unlikely to be of clinical importance. Cooling treatment (cold gel pad) + compression versus placebo (gel pad + compression) There was limited low-certainty evidence that there may be a trivial MD of -0.43 in pain on a 10-point scale at 24 to 48 hours after giving birth (95% CI -0.73 to -0.13; 1 study, 250 participants) when a cooling treatment plus compression from a well-secured perineal pad was compared with the placebo. Levels of perineal oedema may be similar for the two groups (low-certainty evidence) and perineal bruising was not observed. There was low-certainty evidence that women may rate their satisfaction as being slightly higher with perineal care in the cold gel pad and compression group (MD 0.88, 95% CI 0.38 to 1.38; 1 trial, 250 participants). Cooling treatment (ice pack) versus placebo (water pack) One study reported that no women reported pain after using an ice pack or a water pack when asked within 24 hours of giving birth. There was low-certainty evidence that oedema may be similar for the two groups when assessed at four to six hours (RR 0.96, 95% CI 0.50 to 1.86; 1 study, 63 participants) or within 24 hours of giving birth (RR 0.36, 95% CI 0.08 to 1.59). No women were observed to have perineal bruising at these times. The trialists reported that no women in either group experienced any adverse effects on wound healing. There was very low-certainty evidence that women may rate their views and experiences with the treatments similarly (for example, satisfied with treatment: RR 0.91, 95% CI 0.77 to 1.08; 63 participants). Cooling treatment (ice pack) versus cooling treatment (cold gel pad) The evidence is very uncertain about the effects of using ice packs or cold gel pads on women's self-rated perineal pain, on perineal bruising, or on perineal oedema at four to six hours or within 24 hours of giving birth. Perineal oedema may persist 24 to 48 hours after giving birth in women using the ice packs (RR 1.69, 95% CI 1.03 to 2.7; 2 trials, 264 participants; very low-certainty). The risk of gaping wound edges five days after giving birth may be decreased in women who had used ice packs (RR 0.22, 95% CI 0.05 to 1.01; 215 participants; very low-certainty). However, this did not appear to persist to day 10 (RR 3.06, 95% CI 0.63 to 14.81; 214 participants). Women may rate their opinion of treatment less favourably following the use of ice packs five days after giving birth (RR 0.33, 95% CI 0.17 to 0.68; 1 study, 49 participants) and when assessed on day 10 (RR 0.82, 95% CI 0.73 to 0.92; 1 study, 208 participants), both very low-certainty.
AUTHORS' CONCLUSIONS
There is limited very low-certainty evidence that may support the use of cooling treatments, in the form or ice packs or cold gel pads, for the relief of perineal pain in the first two days following childbirth. It is likely that concurrent use of several treatments is required to adequately address this issue, including prescription and non-prescription analgesia. Studies included in this review involved the use of cooling treatments for 10 to 20 minutes, and although no adverse effects were noted, these findings came from studies of relatively small numbers of women, or were not reported at all. The continued lack of high-certainty evidence of the benefits of cooling treatments should be viewed with caution, and further well-designed trials should be conducted.",2020,"To evaluate the effectiveness of localised cooling treatments compared with no treatment, placebo, or other cooling treatments applied to the perineum for pain relief following perineal trauma sustained during childbirth.
","['perineal trauma sustained during childbirth', '10 RCTs that enrolled 1233 women']","['Cooling treatment (ice pack) versus cooling treatment (cold gel pad', 'ice packs or cold gel pads', 'placebo', 'Cooling treatment (ice pack or cold gel pad', 'Local cooling', 'cooling treatment (ice, cold gel pad, cooling plus compression, cooling plus compression plus (being) horizontal) compared with another cooling treatment, no treatment, or placebo (water pack, compression', 'Cooling treatment (ice pack) versus placebo (water pack', 'Cooling treatment (cold gel pad) + compression versus placebo (gel pad + compression']","['adverse effects on wound healing', 'Perineal oedema', 'perineal pain', 'perineal bruising', 'Levels of perineal oedema', ""women's self-rated perineal pain, on perineal bruising, or on perineal oedema"", 'giving birth (risk ratio (RR', 'pain']","[{'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0181264', 'cui_str': 'Ice bag'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0235641', 'cui_str': 'Pain in female perineum'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",250.0,0.513131,"To evaluate the effectiveness of localised cooling treatments compared with no treatment, placebo, or other cooling treatments applied to the perineum for pain relief following perineal trauma sustained during childbirth.
","[{'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'East', 'Affiliation': 'School of Nursing and Midwifery, La Trobe University/Mercy Hospital for Women, Bundoora, Australia.'}, {'ForeName': 'Emma Df', 'Initials': 'ED', 'LastName': 'Dorward', 'Affiliation': 'Glen Iris, Australia.'}, {'ForeName': 'Rhiannon E', 'Initials': 'RE', 'LastName': 'Whale', 'Affiliation': 'Melbourne, Australia.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Antenatal/Postnatal Ward, Mercy Hospital for Women, Heidelberg, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD006304.pub4']
3154,33037810,Effect of zinc on oropharyngeal mucositis in children with acute leukemia undergoing chemotherapy.,"BACKGROUND
Oropharyngeal mucositis (OM) is one of the main side-effects of oncological therapy. There is no treatment to prevent its occurrence, but some zinc-based therapies have been proven to help in decreasing its intensity. The objective of this study was to determine the effect of zinc in OM in children with acute leukemia in the early stages of oncological treatment.
MATERIAL AND METHODS
This quasi-experimental study evaluated OM in 2 groups (control group: conventional hospital management, and experimental group: administration of 50 mg of zinc gluconate daily plus conventional hospital management). OM severity was recorded at a two-month follow-up.
RESULTS
Forty-nine patients (26 in the control group and 23 in the experimental group) were included. The mean age of the patients was 11.1 ± 2.7 years; 65.3% had a diagnosis of pre-B acute lymphoblastic leukemia. The incidences of OM in the control group and the experimental group were 46.2% and 26.1%, respectively, but the difference was not significant. Based on a negative binomial regression model, females had, on average, 1.5 more days with OM (p = 0.002), and patients assigned to the experimental group had, on average, 2 less days with OM than the control group (p = 0.001). The pain score was higher in the control group (p = 0.0009), as was the mean score on the WHO scale (p = 0.0012).
CONCLUSIONS
Zinc facilitated a reduction in the severity and duration of OM; further studies focusing on children are needed to confirm the effects of this trace element.",2020,"The pain score was higher in the control group (p = 0.0009), as was the mean score on the WHO scale (p = 0.0012).
","['children with acute leukemia in the early stages of oncological treatment', 'children with acute leukemia undergoing chemotherapy', 'The mean age of the patients was 11.1 ± 2.7 years; 65.3% had a diagnosis of pre-B acute lymphoblastic leukemia', '2 groups (control group', 'Forty-nine patients (26 in the control group and 23 in the experimental group) were included']","['conventional hospital management, and experimental group: administration of 50 mg of zinc gluconate daily plus conventional hospital management', 'zinc in OM', 'zinc']","['incidences of OM', 'severity and duration of OM', 'mean score on the WHO scale', 'pain score', 'OM severity', 'oropharyngeal mucositis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023485', 'cui_str': 'Leukemia, Pre-B-Cell'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0019948', 'cui_str': 'Administration, Hospital'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0149381', 'cui_str': 'Zinc Gluconate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C1290331', 'cui_str': 'Oropharyngeal mucositis'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1290331', 'cui_str': 'Oropharyngeal mucositis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.0392876,"The pain score was higher in the control group (p = 0.0009), as was the mean score on the WHO scale (p = 0.0012).
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gutiérrez-Vargas', 'Affiliation': 'Oncology Department National Institute of Pediatrics, Health Secretary Insurgentes Sur 3700-C, Insurgentes Cuicuilco Coyoacan, Mexico City, 04530 mzapatatarres@gmail.com.'}, {'ForeName': 'M-Á', 'Initials': 'MÁ', 'LastName': 'Villasis-Keever', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Portilla-Robertson', 'Affiliation': ''}, {'ForeName': 'I-D', 'Initials': 'ID', 'LastName': 'Ascencio-Montiel', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zapata-Tarrés', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23798']
3155,33037918,Palbociclib (PD-0332991) pharmacokinetics in subjects with impaired renal function.,"PURPOSE
This publication describes an evaluation of the impact of different degrees of renal impairment on the pharmacokinetics and safety of palbociclib after a single 125-mg oral dose.
METHODS
Thirty-one subjects were assigned to different renal function groups. Serial blood sampling for pharmacokinetics was performed up to 120 h and 168 h post-palbociclib dose for subjects with normal and impaired renal function, respectively. A separate blood sample was collected at pre-dose and 8 h after dosing to measure plasma protein binding. Plasma palbociclib was measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Plasma protein binding samples were processed by equilibrium dialysis and measured by a validated LC-MS/MS method.
RESULTS
Plasma palbociclib exposure was higher in subjects with renal impairment than in subjects with normal renal function; however, there were no marked differences in exposure across subjects with mild, moderate, and severe renal impairment. Total plasma exposure AUC inf increased by 39%, 42%, and 31% with mild, moderate, and severe renal impairment, respectively, relative to subjects with normal renal function. Peak exposure C max increased by 17%, 12%, and 15% for mild, moderate, and severe impairment, respectively. There was no obvious trend in the mean f u with worsening renal function. The PBPK model adequately described palbociclib exposure observed in subjects with moderate or severe renal impairment from this study.
CONCLUSION
Palbociclib was safe and well-tolerated in a small population of subjects with normal and impaired renal function after a single oral 125 mg dose. No dose adjustment is required in patients with renal impairment.",2020,Palbociclib was safe and well-tolerated in a small population of subjects with normal and impaired renal function after a single oral 125 mg dose.,"['patients with renal impairment', 'subjects with impaired renal function', 'Thirty-one subjects', 'subjects with moderate or severe renal impairment from this study']",['Palbociclib'],"['renal function', 'Plasma palbociclib', 'severe renal impairment', 'Total plasma exposure AUC inf', 'mean f u with worsening renal function', 'Peak exposure C max', 'safe and well-tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",31.0,0.019983,Palbociclib was safe and well-tolerated in a small population of subjects with normal and impaired renal function after a single oral 125 mg dose.,"[{'ForeName': 'Yanke', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, 10555 Science Center Dr, San Diego, CA, 92130, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Hoffman', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, 10555 Science Center Dr, San Diego, CA, 92130, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Plotka', 'Affiliation': 'Biostatistics, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': ""O'Gorman"", 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, 10555 Science Center Dr, San Diego, CA, 92130, USA. Diane.Wang@pfizer.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04163-4']
3156,33035598,Predicting heart failure events in patients with coronary heart disease and impaired glucose tolerance: Insights from the Acarbose Cardiovascular Evaluation (ACE) trial.,"AIMS
Heart failure is a fatal complication of type 2 diabetes but little is known about its incidence in people with impaired glucose tolerance (IGT). We used Acarbose Cardiovascular Evaluation (ACE) trial data to identify predictors of hospitalisation for heart failure (hHF) or cardiovascular (CV) death in patients with coronary heart disease (CHD) and IGT randomised to acarbose or placebo.
METHODS
Independent hHF/CV death risk factors were determined using Cox proportional hazards models, with participants censored at first hHF event, CV death, or end of follow-up.
RESULTS
During median 5-year follow-up, the composite outcome of hHF/CV death occurred in 393 (6.0%) participants. Significant hHF/CV death multivariate predictors were higher age and plasma creatinine, and prior heart failure (HF), myocardial infarction (MI), atrial fibrillation (AF) and stroke. Acarbose, compared with placebo, did not reduce hHF/CV death (hazard ratio [HR] 0.89, 95% CI 0.64-1.24, P = 0.48) or hHF (HR 0.90, 95% CI 0.74-1.10, P = 0.32).
CONCLUSIONS
Patients with CHD and IGT at greater risk of hHF/CV death were older with higher plasma creatinine, prior HF, MI, AF or stroke. Addition of acarbose to optimised CV therapy to reduce post-prandial glucose excursions did not reduce the risk of hHF/CV death or hHF.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, number NCT00829660, and the International Standard Randomised Controlled Trial Number registry, number ISRCTN91899513.",2020,"Acarbose, compared with placebo, did not reduce hHF/CV death (hazard ratio [HR] 0.89, 95% CI 0.64-1.24, P=0.48) or hHF (HR 0.90, 95% CI 0.74-1.10, P=0.32).
","['people with impaired glucose tolerance (IGT', 'Patients with Coronary Heart Disease and Impaired Glucose Tolerance', 'patients with coronary heart disease (CHD']","['acarbose or placebo', 'placebo', 'acarbose to optimised CV therapy', 'Acarbose']","['plasma creatinine, as and prior heart failure (HF), myocardial infarction (MI), atrial fibrillation (AF) and stroke', 'risk of hHF/CV death or hHF', 'heart failure (hHF) or cardiovascular (CV) death', 'hHF/CV death', 'post-prandial glucose excursions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0587038', 'cui_str': 'Cardiovascular therapy'}]","[{'cui': 'C1278055', 'cui_str': 'Plasma creatinine measurement'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.56588,"Acarbose, compared with placebo, did not reduce hHF/CV death (hazard ratio [HR] 0.89, 95% CI 0.64-1.24, P=0.48) or hHF (HR 0.90, 95% CI 0.74-1.10, P=0.32).
","[{'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Wamil', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Charles A B', 'Initials': 'CAB', 'LastName': 'Scott', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Standl', 'Affiliation': 'Diabetes Research Group eV at Munich Helmholtz Centre, Munich, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine K2, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK. Electronic address: rury.holman@dtu.ox.ac.uk.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108488']
3157,33035599,Liraglutide or insulin glargine treatments improves hepatic fat in obese patients with type 2 diabetes and nonalcoholic fatty liver disease in twenty-six weeks: A randomized placebo-controlled trial.,"BACKGROUND
Type 2 diabetes mellitus is closely related to nonalcoholic fatty liver disease(NAFLD). More and more attention has been paid to the efficacy of liraglutide in the treatment of NAFLD, but the clinical evidence is still insufficient.
OBJECTIVE
The purpose of this study was to use proton magnetic resonance spectroscopy (H-MRS) assessment of metformin alone poor blood glucose control of obese patients type 2 diabetes with NAFLD, added with insulin glargine, liraglutide or placebo effect in improving the fatty liver.
METHODS
This is a 26-week, single-center, prospective, randomized placebo-controlled study. From September 2016 to July 2018, 128 patients with type 2 diabetes and NAFLD were enrolled in the China joint logistics team 900 hospital. The primary endpoints were the changes in intrahepatic content of lipid (IHCL), abdominal adiposity [subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)], from baseline to week 26 (end of treatment) and the changes in liraglutide group or insulin glargine group versus change in placebo group. Secondary endpoints included the changes in liver function (AST and ALT), glycemia (HbA1c and FPG), body weight, and BMI.
RESULTS
A total of 96 patients with type 2 diabetes and NAFLD under inadequate glycemic control by metformin were randomized (1:1:1) to receive add-on insulin glargine, liraglutide, or placebo. After 26 weeks of treatment, compared to the placebo group, in the liraglutide and insulin glargine groups, IHCL significantly decreased from baseline to week 26 (liraglutide 26.4% ± 3.2% to 20.6% ± 3.9%, P < 0.05; insulin glargine 25.0% ± 4.3% to 22.6% ± 5.8%, P > 0.05). SAT and VAT decreased significantly in the liraglutide group and in the insulin glargine group (P < 0.05). ΔSAT and ΔVAT were greater with liraglutide than insulin glargine, they were significantly different between the two groups (ΔSAT, -36 vs. - 24.5, P < 0.05; and ΔVAT, -47 vs. - 16.6, P > 0.05). In the liraglutide group, AST, ALT, and HOMA-IR decreased significantly from baseline. There was no significant difference in glucose-lowering among the three groups. During the treatment, the safety of the three groups performed well.
CONCLUSION
Compared with placebo, treatment with liraglutide plus an adequate dose of metformin (2000 g/ day) for 26 weeks is more effective in reducing IHCL, SAT and VAT in patients with type 2 diabetes and NAFLD. And it has additional advantages in weight loss, waist circumference reduction and liver function improvement.",2020,"ΔSAT and ΔVAT were greater with liraglutide than insulin glargine, they were significantly different between the two groups (ΔSAT, -36 vs.-24.5, P < 0.05; and ΔVAT, -47 vs.-16.6, P > 0.05).","['From September 2016 to July 2018, 128 patients with type 2 diabetes and NAFLD were enrolled in the China joint logistics team 900 hospital', 'patients with type 2 diabetes and NAFLD', '96 patients with type 2 diabetes and NAFLD under inadequate glycemic control by', 'obese patients with type 2 diabetes and nonalcoholic fatty liver disease in twenty-six weeks', 'obese patients type 2 diabetes with NAFLD, added with']","['insulin glargine, liraglutide or placebo', 'proton magnetic resonance spectroscopy (H-MRS', 'liraglutide', 'insulin glargine, liraglutide, or placebo', 'metformin', 'placebo', 'insulin glargine', 'liraglutide and insulin glargine', 'Liraglutide or insulin glargine treatments']","['changes in intrahepatic content of lipid (IHCL), abdominal adiposity [subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT', 'changes in liver function (AST and ALT), glycemia (HbA1c and FPG), body weight, and BMI', 'blood glucose control', 'weight loss, waist circumference reduction and liver function improvement', 'hepatic fat', 'SAT and VAT', 'glucose-lowering', 'ΔSAT and ΔVAT', 'IHCL, SAT and VAT', 'IHCL', 'AST, ALT, and HOMA-IR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0242415', 'cui_str': 'Logistics'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",96.0,0.0676648,"ΔSAT and ΔVAT were greater with liraglutide than insulin glargine, they were significantly different between the two groups (ΔSAT, -36 vs.-24.5, P < 0.05; and ΔVAT, -47 vs.-16.6, P > 0.05).","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fuzhou 365000, Fujian, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Tian', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fuzhou 365000, Fujian, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fuzhou 365000, Fujian, China.'}, {'ForeName': 'Xiangjin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fuzhou 365000, Fujian, China. Electronic address: xu98111@163.com.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108487']
3158,33035700,"Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate following once-daily inhalation as a combination in healthy subjects.","Indacaterol (IND), is co-formulated with glycopyrronium (GLY), and mometasone furoate (MF) as a once-daily (o.d.) inhaled fixed-dose combination (IND/GLY/MF) delivered via the Breezhaler® device for maintenance treatment of asthma. We evaluated the steady state plasma pharmacokinetics (PK) of IND, GLY and MF following inhalation of IND/GLY/MF or as monotherapies. This was a randomized, open-label, four-way crossover study. Subjects received IND/GLY/MF 150/50/160 μg (high-dose), IND 150 μg, GLY 50 μg or MF 190 μg (in vitro fine particle mass comparable to 160 μg MF in IND/GLY/MF) via the Breezhaler® device, o.d. for 14 days in each period, with a washout of at least 7 days. PK was characterized on Day 14, up to 24 h post-dose. In total, 36 healthy subjects were randomized. For IND, the geometric mean ratios (90% CI) for AUC0-24h,ss and Cmax,ss were 0.922 (0.878, 0.969) and 1.02 (0.967, 1.08), respectively for the IND/GLY/MF versus IND monotherapy comparison. For GLY, the geometric mean ratios (90% CI) for AUC0-24h,ss and Cmax,ss were 0.986 (0.944, 1.03) and 1.21 (1.09, 1.34), respectively for the IND/GLY/MF versus GLY comparison. For MF, the geometric mean ratios (90% CI) for AUC0-24h,ss and Cmax,ss were 1.16 (1.09, 1.24) and 1.17 (1.09, 1.25), respectively for IND/GLY/MF versus MF comparison. Similar systemic exposure was noted for IND/GLY/MF versus monotherapy for all three mono-components, indicating a lack of PK interaction. Multiple inhaled doses of IND, GLY and MF were safe and well tolerated, when administered alone or in combination. There was no clinically relevant pharmacokinetic interaction between IND, GLY and MF when administered as IND/GLY/MF.",2020,"For MF, the geometric mean ratios (90% CI) for AUC0-24h, ss and Cmax, ss were 1.16 (1.09, 1.24) and 1.17 (1.09, 1.25), respectively for IND/GLY/MF versus MF comparison.","['36 healthy subjects', 'healthy subjects']","['glycopyrronium (GLY), and mometasone furoate (MF', 'IND/GLY/MF', 'inhaled fixed-dose combination (IND/GLY/MF) delivered via the Breezhaler® device', 'IND, GLY and MF', 'Indacaterol (IND', 'indacaterol, glycopyrronium and mometasone furoate']","['geometric mean ratios', 'steady state plasma pharmacokinetics (PK) of IND, GLY and MF following inhalation of IND/GLY/MF', 'safe and well tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]",36.0,0.0285696,"For MF, the geometric mean ratios (90% CI) for AUC0-24h, ss and Cmax, ss were 1.16 (1.09, 1.24) and 1.17 (1.09, 1.25), respectively for IND/GLY/MF versus MF comparison.","[{'ForeName': 'Soniya', 'Initials': 'S', 'LastName': 'Vaidya', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, USA.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Jauernig', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Ethell', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, USA.'}, {'ForeName': 'Nasri', 'Initials': 'N', 'LastName': 'Abdallah', 'Affiliation': 'Novartis Institutes for BioMedical Research, Translational Medicine, Basel, Switzerland.'}, {'ForeName': 'Surendra', 'Initials': 'S', 'LastName': 'Machineni', 'Affiliation': 'Novartis Healthcare Pvt. Ltd., Hyderabad, India.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Drollmann', 'Affiliation': 'Novartis Institutes for BioMedical Research, Translational Medicine, Basel, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Heudi', 'Affiliation': 'Novartis Institutes for BioMedical Research, Translational Medicine, Basel, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Last', 'Affiliation': 'Charité Research Organisation GmbH, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hahn', 'Affiliation': 'Novartis Institutes for BioMedical Research, Translational Medicine, Basel, Switzerland.'}, {'ForeName': 'Rajkumar', 'Initials': 'R', 'LastName': 'Radhakrishnan', 'Affiliation': 'Novartis Healthcare Pvt. Ltd., Hyderabad, India.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Ignatenko', 'Affiliation': 'Charité Research Organisation GmbH, Berlin, Germany.'}, {'ForeName': 'Hanns-Christian', 'Initials': 'HC', 'LastName': 'Tillmann', 'Affiliation': 'Novartis Institutes for BioMedical Research, Translational Medicine, Basel, Switzerland. Electronic address: hanns-christian.tillmann@novartis.com.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101964']
3159,33038262,Choir singing improves respiratory muscle strength and quality of life in patients with structural heart disease - HeartChoir: a randomised clinical trial.,"AIMS OF THE STUDY
Most patients with reduced exercise capacity and acquired or congenital structural heart disease also have a reduced respiratory muscle strength. The aim of this pilot study was to investigate whether choir singing in combination with respiratory muscle training positively influences respiratory muscle strength, exercise capacity and quality of life in this population.
METHODS
In this single-centre, randomised and open-label interventional study we compared respiratory muscle strength, exercise capacity and quality of life in patients with acquired or congenital structural heart disease who received either standard of care and a 12-week intervention (weekly choir rehearsal and daily breathing exercises) or standard of care alone. The primary endpoint was the difference in change in maximum inspiratory pressure (∆MIP%predicted). Secondary endpoints included the difference in change in maximum expiratory pressure (∆MEP%predicted), exercise capacity quantified as maximal oxygen uptake during exercise (∆MVO2%predicted) and quality of life quantified by the Minnesota living with heart failure questionnaire (∆MLHFQ score).
RESULTS
Overall 24 patients (mean age 65, standard deviation [SD] 19 years, 46% male) were randomised after exclusion. ∆MIP%predicted was significantly higher in the intervention group (∆MIP%predicted +14, SD 21% vs −14, SD 23%; p = 0.008) and quality of life improved significantly (∆MLHFQ score −5, SD 6 vs 3, SD 5; p = 0.006) after 12 weeks. ∆MEP%predicted and ∆MVO2%predicted did not differ between both groups (∆MEP%predicted −3, SD 26% vs −3, SD 16%; p = 1.0 and ∆MVO2%predicted 18, SD 12% vs 10, SD 15%; p = 0.2).
CONCLUSIONS
Choir singing in combination with respiratory muscle training improved respiratory muscle strength and quality of life in patients with structural heart disease and may therefore be valuable supplements in cardiac rehabilitation. (Clinical trial registration number: NCT03297918) .",2020,"∆MIP%predicted was significantly higher in the intervention group (∆MIP%predicted +14, SD 21% vs −14, SD 23%; p = 0.008) and quality of life improved significantly (∆MLHFQ score −5, SD 6 vs 3, SD 5; p = 0.006) after 12 weeks.","['19 years, 46% male', 'patients with structural heart disease - HeartChoir', 'patients with acquired or congenital structural heart disease who received either', 'Overall 24 patients (mean age 65, standard deviation [SD', 'Most patients with reduced exercise capacity and acquired or congenital structural heart disease', 'patients with structural heart disease']","['Choir singing in combination with respiratory muscle training', 'standard of care and a 12-week intervention (weekly choir rehearsal and daily breathing exercises) or standard of care alone', 'choir singing in combination with respiratory muscle training', 'Choir singing']","['change in maximum expiratory pressure (∆MEP%predicted), exercise capacity quantified as maximal oxygen uptake during exercise (∆MVO2%predicted) and quality of life quantified by the Minnesota living with heart failure questionnaire (∆MLHFQ score', 'maximum inspiratory pressure (∆MIP%predicted', 'respiratory muscle strength and quality of life', '∆MEP%predicted and ∆MVO2%predicted', 'quality of life', 'respiratory muscle strength, exercise capacity and quality of life']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}]","[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}]",,0.235722,"∆MIP%predicted was significantly higher in the intervention group (∆MIP%predicted +14, SD 21% vs −14, SD 23%; p = 0.008) and quality of life improved significantly (∆MLHFQ score −5, SD 6 vs 3, SD 5; p = 0.006) after 12 weeks.","[{'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Ganzoni', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Ketina', 'Initials': 'K', 'LastName': 'Arslani', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland / Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, Switzerland.'}, {'ForeName': 'Otmar', 'Initials': 'O', 'LastName': 'Pfister', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Freese', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland / Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, Switzerland.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Strobel', 'Affiliation': 'Department of Pneumology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mueller', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland / Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tobler', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland.'}]",Swiss medical weekly,['10.4414/smw.2020.20346']
3160,33041107,Patterns of Physical Activity Progression in Patients With COPD.,"INTRODUCTION
Although mean physical activity in COPD patients declines by 400-500steps/day annually, it is unknown whether the natural progression is the same for all patients. We aimed to identify distinct physical activity progression patterns using a hypothesis-free approach and to assess their determinants.
METHODS
We pooled data from two cohorts (usual care arm of Urban Training [NCT01897298] and PROactive initial validation [NCT01388218] studies) measuring physical activity at baseline and 12 months (Dynaport MoveMonitor). We identified clusters (patterns) of physical activity progression (based on levels and changes of steps/day) using k-means, and compared baseline sociodemographic, interpersonal, environmental, clinical and psychological characteristics across patterns.
RESULTS
In 291 COPD patients (mean±SD 68±8 years, 81% male, FEV 1 59±19% pred ) we identified three distinct physical activity progression patterns: Inactive (n=173 [59%], baseline: 4621±1757 steps/day, 12-month change (Δ): -487±1201 steps/day), ActiveImprovers (n=49 [17%], baseline: 7727±3275 steps/day, Δ:+3378±2203 steps/day) and ActiveDecliners (n=69 [24%], baseline: 11 267±3009 steps/day, Δ: -2217±2085 steps/day). After adjustment in a mixed multinomial logistic regression model using Active Decliners as reference pattern, a lower 6-min walking distance (RRR [95% CI] 0.94 [0.90-0.98] per 10m, P=.001) and a higher mMRC dyspnea score (1.71 [1.12-2.60] per 1 point, P=.012) were independently related with being Inactive. No baseline variable was independently associated with being an Active Improver.
CONCLUSIONS
The natural progression in physical activity over time in COPD patients is heterogeneous. While Inactive patients relate to worse scores for clinical COPD characteristics, Active Improvers and Decliners cannot be predicted at baseline.",2020,"No baseline variable was independently associated with being an Active Improver.
","['COPD patients', '291 COPD patients (mean±SD 68±8 years, 81% male, FEV 1 59±19% pred ) we identified three distinct physical activity progression patterns: Inactive (n=173 [59%], baseline: 4621±1757 steps/day, 12-month change (Δ): -487±1201 steps/day), ActiveImprovers (n=49 [17%], baseline: 7727±3275 steps/day, Δ:+3378±2203 steps/day) and ActiveDecliners (n=69 [24%], baseline: 11 267±3009 steps/day, Δ', 'Patients With COPD']",[],"['mMRC dyspnea score', 'mean physical activity', 'physical activity']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205449', 'cui_str': '3'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",[],"[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",291.0,0.101945,"No baseline variable was independently associated with being an Active Improver.
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Koreny', 'Affiliation': 'ISGlobal, Barcelona, Spain; Pompeu Fabra University (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Demeyer', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven - University of Leuven, Leuven, Belgium; Department of Respiratory Diseases, University Hospitals KU Leuven, Leuven, Belgium; Department of Rehabilitation Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Benet', 'Affiliation': 'ISGlobal, Barcelona, Spain; Pompeu Fabra University (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Ane', 'Initials': 'A', 'LastName': 'Arbillaga-Etxarri', 'Affiliation': 'Physical Activity and Sports Sciences, Faculty of Psychology and Education, University of Deusto, Donostia-San Sebastián, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Balcells', 'Affiliation': ""Pompeu Fabra University (UPF), Barcelona, Spain; CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain; Pneumology Department, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Hospital del Mar, Barcelona, Spain.""}, {'ForeName': 'Anael', 'Initials': 'A', 'LastName': 'Barberan-Garcia', 'Affiliation': ""University of Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), CIBER Enfermedades Respiratorias (CIBERES), Hospital Clínic, Barcelona, Spain.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gimeno-Santos', 'Affiliation': ""University of Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), CIBER Enfermedades Respiratorias (CIBERES), Hospital Clínic, Barcelona, Spain.""}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Hopkinson', 'Affiliation': 'National Heart and Lung Institute, Imperial College, Royal Brompton Hospital Campus, London UK.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'De Jong', 'Affiliation': 'Department of General Practice, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands; Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Karlsson', 'Affiliation': 'Patient Centered Science, BioPharmaceuticals, AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Zafeiris', 'Initials': 'Z', 'LastName': 'Louvaris', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven - University of Leuven, Leuven, Belgium; First Department of Respiratory Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Polkey', 'Affiliation': 'National Heart and Lung Institute, Imperial College, Royal Brompton Hospital Campus, London UK.'}, {'ForeName': 'Milo A', 'Initials': 'MA', 'LastName': 'Puhan', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Roberto A', 'Initials': 'RA', 'LastName': 'Rabinovich', 'Affiliation': ""ELEGI Colt Laboratory, Centre for Inflammation Research, The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rodríguez-Roisin', 'Affiliation': ""University of Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), CIBER Enfermedades Respiratorias (CIBERES), Hospital Clínic, Barcelona, Spain.""}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Vall-Casas', 'Affiliation': 'Universitat Internacional de Catalunya (UIC), Barcelona, Spain.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Vogiatzis', 'Affiliation': 'First Department of Respiratory Medicine, National and Kapodistrian University of Athens, Athens, Greece; Department of Sport, Exercise and Rehabilitation, Northumbria University Newcastle, Newcastle UK.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Troosters', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven - University of Leuven, Leuven, Belgium; Department of Respiratory Diseases, University Hospitals KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Garcia-Aymerich', 'Affiliation': 'ISGlobal, Barcelona, Spain; Pompeu Fabra University (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain. Electronic address: judith.garcia@isglobal.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Archivos de bronconeumologia,['10.1016/j.arbres.2020.08.001']
3161,33043163,Remdesivir for coronavirus 2019 (COVID-19): More promising but still unproven.,"From December 2019 to May 22, 2020 the emerging and ever-increasing pandemic of coronavirus 19 (COVID-19) had no effective and safe treatment. Not surprisingly, remdesivir attracted worldwide attention. In a trial published online ahead of print, of 1063 patients, 541 were assigned at random to remdesivir and 522 to placebo. The primary prespecified endpoint was mean recovery time and patients assigned to remdesivir had a mean recovery time of 11 days versus 15 days for those assigned a random to placebo. (p < 0.001). With respect to mortality, the prespecfied secondary endpoint, 34/538 patients in remdesivir and 54/521 in placebo died after 28 days, yielding a possible 31% reduction that approached but did not achieve statistical significance (p = 0.059). The only other published trial of remdesivir randomized 237 patients in China. In that trial, 178 patients were assigned at random to remdesivir compared to 79 assigned to placebo. Those assigned at random to remdesivir experienced a possible but nonsignificant 23% faster time to clinical improvement of 21 days compared with 23 for those assigned to placebo [hazard ratio 1.23 [95% CI, 0·87-1.75)]. With respect to mortality there was no suggestion of any benefit. In fact, the mortality rate in those receiving remdesivir was 15% (22/150) compared with 13% (10/77) for those assigned to placebo. Ongoing randomized trials should be designed, conducted and analyzed to provide the necessary reliable data on mortality to resolve the remaining clinical uncertainties.",2020,With respect to mortality there was no suggestion of any benefit.,"['1063 patients, 541 were assigned at random to remdesivir and 522 to', 'Remdesivir for coronavirus 2019 (COVID-19', '237 patients in China', '178 patients']",['placebo'],"['mean recovery time', 'mortality rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C4517804', 'cui_str': '522'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",237.0,0.308104,With respect to mortality there was no suggestion of any benefit.,"[{'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Shih', 'Affiliation': 'Charles E. Schmidt College of Medicine, Florida Atlantic University, Departments of Emergency Medicine, Bethesda Hospital East and Delray Medical Center, USA.'}, {'ForeName': 'Dennis G', 'Initials': 'DG', 'LastName': 'Maki', 'Affiliation': 'University of Wisconsin School of Medicine & Public Health, USA.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hennekens', 'Affiliation': 'First Sir Richard Doll Professor & Senior Academic Advisor to the Dean Charles E. Schmidt College of Medicine, Florida Atlantic University, 2800, S. Ocean Blvd. PHA Boca Raton, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100663']
3162,33038944,Redevelopment and validation of the SYNTAX score II to individualise decision making between percutaneous and surgical revascularisation in patients with complex coronary artery disease: secondary analysis of the multicentre randomised controlled SYNTAXES trial with external cohort validation.,"BACKGROUND
Randomised controlled trials are considered the gold standard for testing the efficacy of novel therapeutic interventions, and typically report the average treatment effect as a summary result. As the result of treatment can vary between patients, basing treatment decisions for individual patients on the overall average treatment effect could be suboptimal. We aimed to develop an individualised decision making tool to select an optimal revascularisation strategy in patients with complex coronary artery disease.
METHODS
The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries between March, 2005, and April, 2007. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to either the percutaneous coronary intervention (PCI) group or coronary artery bypass grafting (CABG) group. The SYNTAXES study ascertained 10-year all-cause deaths. We used Cox regression to develop a clinical prognostic index for predicting death over a 10-year period, which was combined, in a second stage, with assigned treatment (PCI or CABG) and two prespecified effect-modifiers, which were selected on the basis of previous evidence: disease type (three-vessel disease or left main coronary artery disease) and anatomical SYNTAX score. We used similar techniques to develop a model to predict the 5-year risk of major adverse cardiovascular events (defined as a composite of all-cause death, non-fatal stroke, or non-fatal myocardial infarction) in patients receiving PCI or CABG. We then assessed the ability of these models to predict the risk of death or a major adverse cardiovascular event, and their differences (ie, the estimated benefit of CABG versus PCI by calculating the absolute risk difference between the two strategies) by cross-validation with the SYNTAX trial (n=1800 participants) and external validation in the pooled population (n=3380 participants) of the FREEDOM, BEST, and PRECOMBAT trials. The concordance (C)-index was used to measure discriminative ability, and calibration plots were used to assess the degree of agreement between predictions and observations.
FINDINGS
At cross-validation, the newly developed SYNTAX score II, termed SYNTAX score II 2020, showed a helpful discriminative ability in both treatment groups for predicting 10-year all-cause deaths (C-index=0·73 [95% CI 0·69-0·76] for PCI and 0·73 [0·69-0·76] for CABG) and 5-year major adverse cardiovascular events (C-index=0·65 [0·61-0·69] for PCI and C-index=0·71 [0·67-0·75] for CABG). At external validation, the SYNTAX score II 2020 showed helpful discrimination (C-index=0·67 [0·63-0·70] for PCI and C-index=0·62 [0·58-0·66] for CABG) and good calibration for predicting 5-year major adverse cardiovascular events. The estimated treatment benefit of CABG over PCI varied substantially among patients in the trial population, and the benefit predictions were well calibrated.
INTERPRETATION
The SYNTAX score II 2020 for predicting 10-year deaths and 5-year major adverse cardiovascular events can help to identify individuals who will benefit from either CABG or PCI, thereby supporting heart teams, patients, and their families to select optimal revascularisation strategies.
FUNDING
The German Heart Research Foundation and the Patient-Centered Outcomes Research Institute.",2020,"At external validation, the SYNTAX score II 2020 showed helpful discrimination (C-index=0·67 [0·63-0·70] for PCI and C-index=0·62 [0·58-0·66] for CABG) and good calibration for predicting 5-year major adverse cardiovascular events.","['patients receiving PCI or CABG', 'patients with complex coronary artery disease', 'Patients with de-novo three-vessel and left main coronary artery disease', '85 hospitals across 18 North American and European countries between March, 2005, and April, 2007']","['CABG', 'percutaneous and surgical revascularisation', 'percutaneous coronary intervention (PCI) group or coronary artery bypass grafting (CABG']","['10-year deaths and 5-year major adverse cardiovascular events', '5-year major adverse cardiovascular events', '5-year risk of major adverse cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1299433', 'cui_str': 'Left main coronary artery disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1800.0,0.111592,"At external validation, the SYNTAX score II 2020 showed helpful discrimination (C-index=0·67 [0·63-0·70] for PCI and C-index=0·62 [0·58-0·66] for CABG) and good calibration for predicting 5-year major adverse cardiovascular events.","[{'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Amsterdam Universities Medical Centers, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway, Ireland. Electronic address: patrick.w.j.c.serruys@gmail.com.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Zena and Michael Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Centro Nacional De Investigaciones Cardiovasculares Carlos III, Madrid, Spain.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Peter Munk Cardiac Centre and The Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO, USA; University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': 'Department of Cardiology, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Head', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Daniel Jfm', 'Initials': 'DJ', 'LastName': 'Thuijs', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kent', 'Affiliation': 'Predictive Analytics and Comparative Effectiveness Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Ewout W', 'Initials': 'EW', 'LastName': 'Steyerberg', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden, Netherlands; University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'van Klaveren', 'Affiliation': 'Department of Public Health, Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)32114-0']
3163,32861830,Improving uptake of hepatitis B and hepatitis C testing in South Asian migrants in community and faith settings using educational interventions-A prospective descriptive study.,"BACKGROUND
Chronic viral hepatitis (CVH) is a leading contributor to the UK liver disease epidemic, with global migration from high prevalence areas (e.g., South Asia). Despite international guidance for testing high-risk groups in line with elimination targets, there is no consensus on how to achieve this. The objectives of this study were to assess the following: (1) the feasibility of recruiting South Asian migrants to view an educational film on CVH, (2) the effectiveness of the film in promoting testing and increasing knowledge of CVH, and (3) the methodological issues relevant to scale-up to a randomized controlled trial.
METHODS
South Asian migrants were recruited to view the film (intervention) in community venues (primary care, religious, community), with dried blood spot CVH testing offered immediately afterwards. Pre/post-film questionnaires assessed the effectiveness of the intervention.
RESULTS
Two hundred and nineteen first-generation migrants ≥18 years of age (53% female) were recruited to view the film at the following sites: religious, n = 112 (51%), community n = 98 (45%), and primary care, n = 9 (4%). One hundred and eighty-four (84%) underwent CVH testing; hepatitis B core antibody or hepatitis C antibody positivity demonstrated exposure in 8.5%. Pre-intervention (n = 173, 79%) and post-intervention (n = 154, 70%) questionnaires were completed.
CONCLUSIONS
This study demonstrated the feasibility of recruiting first-generation migrants to view a community-based educational film promoting CVH testing in this higher risk group, confirming the value of developing interventions to facilitate the global World Health Organization plan for targeted case finding and elimination, and a future randomized controlled trial. We highlight the importance of culturally relevant interventions including faith and culturally sensitive settings, which appear to minimize logistical issues and effectively engage minority groups, allowing ease of access to individuals 'at risk'.",2020,"Pre-intervention (n = 173, 79%) and post-intervention (n = 154, 70%) questionnaires were completed.
","['Chronic viral hepatitis (CVH', 'South Asian migrants were recruited to view the film (intervention) in community venues (primary care, religious, community), with', 'Two hundred and nineteen first-generation migrants ≥18 years of age (53% female']","['hepatitis B and hepatitis C testing', 'dried blood spot CVH testing offered immediately afterwards', 'CVH testing']",[],"[{'cui': 'C0276623', 'cui_str': 'Chronic viral hepatitis'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0026093', 'cui_str': 'Migrant'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C2711110', 'cui_str': 'Hepatitis B and hepatitis C'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0276623', 'cui_str': 'Chronic viral hepatitis'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]",[],,0.0395415,"Pre-intervention (n = 173, 79%) and post-intervention (n = 154, 70%) questionnaires were completed.
","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Surrey NHS Foundation Trust, Guildford, Surrey, UK; Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Marinos', 'Initials': 'M', 'LastName': 'Pericleous', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Surrey NHS Foundation Trust, Guildford, Surrey, UK; Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Brunel Business School, Brunel University, London, UK.'}, {'ForeName': 'Tushna', 'Initials': 'T', 'LastName': 'Vandrevala', 'Affiliation': 'Department of Psychology, Kingston University, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hendy', 'Affiliation': 'Brunel Business School, Brunel University, London, UK.'}, {'ForeName': 'Shuja', 'Initials': 'S', 'LastName': 'Shafi', 'Affiliation': 'Research and Documentation Committee, The Muslim Council of Britain, London, UK.'}, {'ForeName': 'Simon S', 'Initials': 'SS', 'LastName': 'Skene', 'Affiliation': 'Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Department of Clinical and Experimental Medicine, Brighton and Sussex Medical School and Department of Gastroenterology and Hepatology, Brighton and Sussex University Hospital, Brighton, UK.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Edge', 'Affiliation': 'Institute of Epidemiology and Health Care, UCL, London, UK.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Nicholls', 'Affiliation': 'Public Health England South East, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Gore', 'Affiliation': 'The Hepatitis C Trust, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'de Lusignan', 'Affiliation': 'Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Royal College of General Practitioners Research and Surveillance Centre, London, UK.'}, {'ForeName': 'Aftab', 'Initials': 'A', 'LastName': 'Ala', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Surrey NHS Foundation Trust, Guildford, Surrey, UK; Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK. Electronic address: aftab.ala1@nhs.net.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.059']
3164,33053024,COVID-19-associated ARDS treated with DEXamethasone (CoDEX): study design and rationale for a randomized trial.,"OBJECTIVE
The infection caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads worldwide and is considered a pandemic. The most common manifestation of SARS-CoV-2 infection (coronavirus disease 2019 - COVID-19) is viral pneumonia with varying degrees of respiratory compromise and up to 40% of hospitalized patients might develop acute respiratory distress syndrome. Several clinical trials evaluated the role of corticosteroids in non-COVID-19 acute respiratory distress syndrome with conflicting results. We designed a trial to evaluate the effectiveness of early intravenous dexamethasone administration on the number of days alive and free of mechanical ventilation within 28 days after randomization in adult patients with moderate or severe acute respiratory distress syndrome due to confirmed or probable COVID-19.
METHODS
This is a pragmatic, prospective, randomized, stratified, multicenter, open-label, controlled trial including 350 patients with early-onset (less than 48 hours before randomization) moderate or severe acute respiratory distress syndrome, defined by the Berlin criteria, due to COVID-19. Eligible patients will be randomly allocated to either standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group). Patients in the intervention group will receive dexamethasone 20mg intravenous once daily for 5 days, followed by dexamethasone 10mg IV once daily for additional 5 days or until intensive care unit discharge, whichever occurs first. The primary outcome is ventilator-free days within 28 days after randomization, defined as days alive and free from invasive mechanical ventilation. Secondary outcomes are all-cause mortality rates at day 28, evaluation of the clinical status at day 15 assessed with a 6-level ordinal scale, mechanical ventilation duration from randomization to day 28, Sequential Organ Failure Assessment Score evaluation at 48 hours, 72 hours and 7 days and intensive care unit -free days within 28.",2020,Eligible patients will be randomly allocated to either standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group).,"['Eligible patients', '350 patients with early-onset (less than 48 hours before randomization) moderate or severe acute respiratory distress syndrome, defined by the Berlin criteria, due to COVID-19', 'adult patients with moderate or severe acute respiratory distress syndrome due to confirmed or probable COVID-19']","['corticosteroids', 'DEXamethasone (CoDEX', 'dexamethasone', 'standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group']","['ventilator-free days within 28 days after randomization, defined as days alive and free from invasive mechanical ventilation', 'cause mortality rates at day 28, evaluation of the clinical status at day 15 assessed with a 6-level ordinal scale, mechanical ventilation duration from randomization to day 28, Sequential Organ Failure Assessment Score evaluation', 'number of days alive and free of mechanical ventilation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",350.0,0.244425,Eligible patients will be randomly allocated to either standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group).,"[{'ForeName': 'Bruno Martins', 'Initials': 'BM', 'LastName': 'Tomazini', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Israel Silva', 'Initials': 'IS', 'LastName': 'Maia', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Flavia Regina', 'Initials': 'FR', 'LastName': 'Bueno', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Maria Vitoria Aparecida Oliveira', 'Initials': 'MVAO', 'LastName': 'Silva', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Franca Pellison', 'Initials': 'FP', 'LastName': 'Baldassare', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Eduardo Leite Vieira', 'Initials': 'ELV', 'LastName': 'Costa', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Ricardo Antonio Bonifácio', 'Initials': 'RAB', 'LastName': 'Moura', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Michele Ouriques', 'Initials': 'MO', 'LastName': 'Honorato', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'André Nathan', 'Initials': 'AN', 'LastName': 'Costa', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': 'Alexandre Biasi', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Regis Goulart', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Avezum', 'Affiliation': 'Hospital Alemão Oswaldo Cruz - São Paulo (SP), Brasil.'}, {'ForeName': 'Viviane Cordeiro', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'Hospital Beneficência Portuguesa - São Paulo (SP), Brasil.'}, {'ForeName': 'Renato Delascio', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Brazilian Clinical Research Institute (BCRI) - São Paulo (SP), Brasil.'}, {'ForeName': 'Lucas Petri', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Flávia Ribeiro', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Hospital Israelita Albert Einstein - São Paulo (SP), Brasil.'}, {'ForeName': 'Luciano César Pontes de', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Hospital Sírio-Libanês - São Paulo (SP), Brasil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Revista Brasileira de terapia intensiva,['10.5935/0103-507X.20200063']
3165,33053622,Ticagrelor Versus Clopidogrel in Older Patients with NSTE-ACS Using Oral Anticoagulation: A Sub-Analysis of the POPular Age Trial.,"There are no randomised data on which antiplatelet agent to use in elderly patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) and an indication for oral anticoagulation (OAC). The randomised POPular Age trial, in patients of 70 years or older with NSTE-ACS, showed a reduction in bleeding without increasing thrombotic events in patients using clopidogrel as compared to ticagrelor. In this sub-analysis of the POPular AGE trial, we compare clopidogrel with ticagrelor in patients with a need for oral anticoagulation. The follow-up duration was one year. The primary bleeding outcome was Platelet Inhibition and Patient Outcomes (PLATO) major and minor bleeding. The primary thrombotic outcome consisted of cardiovascular death, myocardial infarction and stroke. The primary net clinical benefit outcome was a composite of all-cause death, myocardial infarction, stroke, and PLATO major and minor bleeding. A total of 184/1011 (18.2%) patients on OAC were included in this subanalysis; 83 were randomized to clopidogrel and 101 to ticagrelor. The primary bleeding outcome was lower in the clopidogrel group (17/83, 20.9%) compared to the ticagrelor group (33/101, 33.5%; p = 0.051), as was the thrombotic outcome (7/83, 8.4% vs. 19/101, 19.2%; p = 0.035) and the primary net clinical benefit outcome (23/83, 27.7% vs. 49/101, 48.5%; p = 0.003). In this subgroup of patients using OAC, clopidogrel reduced PLATO major and minor bleeding compared to ticagrelor without increasing thrombotic risk. This analysis therefore suggests that, in line with the POPular Age trial, clopidogrel is a better option than ticagrelor in NSTE-ACS patients ≥70 years using OAC.",2020,"In this subgroup of patients using OAC, clopidogrel reduced PLATO major and minor bleeding compared to ticagrelor without increasing thrombotic risk.","['A total of 184/1011 (18.2%) patients on OAC', 'patients with a need for oral anticoagulation', 'Older Patients with NSTE-ACS', 'elderly patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) and an indication for oral anticoagulation (OAC', 'patients of 70 years or older with NSTE-ACS']","['Oral Anticoagulation', 'clopidogrel with ticagrelor', 'Ticagrelor Versus Clopidogrel', 'clopidogrel', 'ticagrelor']","['primary bleeding outcome', 'thrombotic risk', 'bleeding without increasing thrombotic events', 'composite of all-cause death, myocardial infarction, stroke, and PLATO major and minor bleeding', 'thrombotic outcome', 'cardiovascular death, myocardial infarction and stroke', 'Platelet Inhibition and Patient Outcomes (PLATO) major and minor bleeding']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0043566', 'cui_str': '(1,2-diamino-4-nitrobenzene)dichloroplatinum(II)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.110778,"In this subgroup of patients using OAC, clopidogrel reduced PLATO major and minor bleeding compared to ticagrelor without increasing thrombotic risk.","[{'ForeName': 'Marieke E', 'Initials': 'ME', 'LastName': 'Gimbel', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, 3435CM Nieuwegein, The Netherlands.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Tavenier', 'Affiliation': 'Department of Cardiology, Isala, 8025AB Zwolle, The Netherlands.'}, {'ForeName': 'Wilbert', 'Initials': 'W', 'LastName': 'Bor', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, 3435CM Nieuwegein, The Netherlands.'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'Department of Cardiology, Isala, 8025AB Zwolle, The Netherlands.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'de Vrey', 'Affiliation': 'Department of Cardiology, Meander Medical Centre, 3813TZ Amersfoort, The Netherlands.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Heestermans', 'Affiliation': 'Department of Cardiology, Noord-west Hospital group, 1815JD Alkmaar, The Netherlands.'}, {'ForeName': 'Melvyn Tjon Joe', 'Initials': 'MTJ', 'LastName': 'Gin', 'Affiliation': 'Department of Cardiology, Rijnstate, 6815AD Arnhem, The Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Waalewijn', 'Affiliation': 'Department of Cardiology, Gelre Hospitals, 7334DZ Apeldoorn, The Netherlands.'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'Hofma', 'Affiliation': 'Department of Cardiology, Medical Centre Leeuwarden, 8934AD Leeuwarden, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'den Hartog', 'Affiliation': 'Department of Cardiology, Gelderse Vallei Hospital, 6716RP Ede, The Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leids University Medical Centre, 2333ZA Leiden, The Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Medisch Spectrum Twente, 7512KZ Enschede, The Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Voskuil', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, 3584CX Utrecht, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kelder', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, 3435CM Nieuwegein, The Netherlands.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Deneer', 'Affiliation': 'Department of Clinical Pharmacy, Division of Laboratories, Pharmacy, and Biomedical Genetics University, Medical Center Utrecht and Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, 3584CX Utrecht, The Netherlands.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, 3435CM Nieuwegein, The Netherlands.'}]",Journal of clinical medicine,['10.3390/jcm9103249']
3166,33053626,"Effect of Food Containing Paramylon Derived from Euglena gracilis EOD-1 on Fatigue in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial.","Euglena gracilis EOD-1, a kind of microalgae, is known to contain a high proportion of paramylon, a type of β-1,3-glucan. Paramylon derived from E. gracilis EOD-1 is presumed to suppress cellular oxidative injury and expected to reduce fatigue and fatigue sensation. Therefore, we aimed to examine whether food containing paramylon derived from E. gracilis EOD-1 (EOD-1PM) ingestion reduced fatigue and fatigue sensation in healthy adults. We conducted a randomized, double-blind, placebo-controlled, parallel-group comparison study in 66 healthy men and women who ingested a placebo or EOD-1PM daily for 4 weeks (daily life fatigue). Furthermore, at the examination days of 0 and 4 weeks, tolerance to fatigue load was evaluated using mental tasks (task-induced fatigue). We evaluated fatigue sensation using the Visual Analogue Scale, the work efficiency of the advanced trail making test and measured serum antioxidant markers. The EOD-1PM group showed significantly lower levels of physical and mental fatigue sensations and higher levels of work efficiency as well as serum biological antioxidant potential levels than the placebo group. These results indicate that EOD-1PM ingestion reduced fatigue and fatigue sensation, which may be due to an increase in antioxidant potential and maintenance of selective attention during work.",2020,The EOD-1PM group showed significantly lower levels of physical and mental fatigue sensations and higher levels of work efficiency as well as serum biological antioxidant potential levels than the placebo group.,"['Healthy Adults', 'daily for 4 weeks (daily life fatigue', 'healthy adults', '66 healthy men and women who ingested a']","['Food Containing Paramylon', 'EOD-1PM', 'placebo or EOD-1PM', 'EOD-1PM ingestion', 'food containing paramylon derived from E. gracilis EOD-1 (EOD-1PM) ingestion', 'placebo', 'Placebo']","['tolerance to fatigue load', 'fatigue sensation', 'levels of physical and mental fatigue sensations', 'fatigue and fatigue sensation', 'serum biological antioxidant potential levels']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0070074', 'cui_str': 'paramylon'}, {'cui': 'C1509133', 'cui_str': 'post meridiem'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0224439', 'cui_str': 'Structure of gracilis muscle'}]","[{'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4049351', 'cui_str': 'Biological antioxidant potential'}]",66.0,0.441904,The EOD-1PM group showed significantly lower levels of physical and mental fatigue sensations and higher levels of work efficiency as well as serum biological antioxidant potential levels than the placebo group.,"[{'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Kawano', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Naito', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Machiko', 'Initials': 'M', 'LastName': 'Nishioka', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Norihisa', 'Initials': 'N', 'LastName': 'Nishida', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Kobelco Eco-Solutions Co., Ltd., Kobe, Hyogo 651-2241, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Kashiwagi', 'Affiliation': 'Soiken. Inc., Toyonaka, Osaka 560-0082, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Sugino', 'Affiliation': 'Soiken. Inc., Toyonaka, Osaka 560-0082, Japan.'}, {'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'RIKEN Center for Biosystems Dynamics Research, Kobe, Hyogo 650-0047, Japan.'}]",Nutrients,['10.3390/nu12103098']
3167,33053651,Effects of Physical Rehabilitation and Nutritional Intake Management on Improvement in Tongue Strength in Sarcopenic Patients.,"The study aimed to investigate the impact of physical intervention and the amount of nutritional intake on the increase in tongue strength and swallowing function in older adults with sarcopenia. From November 2018 and May 2019, older patients with sarcopenia who were admitted for rehabilitation were analyzed. The intervention employed in the study was the usual physical and occupational therapy for two months. Tongue strength was measured before and after two months of treatment. Data on tongue strength, the amount of energy and protein intake, intervention time, and swallowing function were examined. A total of 95 sarcopenic older patients were included (mean age 83.4 ± 6.5 years). The mean tongue strength after the intervention was significantly increased from 25.4 ± 8.9 kPa to 30.5 ± 7.6 kPa as a result of the treatment ( p < 0.001). After adjusting the confounding factors in the multivariable models, an energy intake of ≥30 kcal/kg/day and a protein intake of ≥1.2 g/kg/day based on the ideal body weight had a significant impact on the increase in tongue strength after the treatment ( p = 0.011 and p = 0.020, respectively). Swallowing function assessed using the Mann Assessment of Swallowing Ability was significantly increased after the treatment (mean difference between pairs: 1.12 [0.53-1.70]; p < 0.001). Physical intervention and strict nutritional management for older inpatients with sarcopenia could be effective to improve tongue strength and swallowing function.",2020,Swallowing function assessed using the Mann Assessment of Swallowing Ability was significantly increased after the treatment (mean difference between pairs: 1.12 [0.53-1.70]; p < 0.001).,"['older adults with sarcopenia', 'Sarcopenic Patients', '95 sarcopenic older patients were included (mean age 83.4 ± 6.5 years', 'older inpatients with sarcopenia', 'From November 2018 and May 2019, older patients with sarcopenia who were admitted for rehabilitation were analyzed']","['Physical Rehabilitation and Nutritional Intake Management', 'Physical intervention and strict nutritional management', 'physical intervention']","['tongue strength, the amount of energy and protein intake, intervention time, and swallowing function', 'mean tongue strength', 'Swallowing function assessed using the Mann Assessment of Swallowing Ability', 'Tongue strength', 'tongue strength', 'tongue strength and swallowing function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0566355', 'cui_str': 'Ability to swallow'}]",95.0,0.0128166,Swallowing function assessed using the Mann Assessment of Swallowing Ability was significantly increased after the treatment (mean difference between pairs: 1.12 [0.53-1.70]; p < 0.001).,"[{'ForeName': 'Ayano', 'Initials': 'A', 'LastName': 'Nagano', 'Affiliation': 'Department of Nursing, Nishinomiya Kyoritsu Neurosurgical Hospital, 11-1 Imazuyamanaka-cho, Nishinomiya, Hyogo 663-8211, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Department of Geriatric Medicine, National Center for Geriatrics and Gerontology, 7-430 Morioka, Obu, Aichi 474-8511, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Koike', 'Affiliation': 'Division of Rehabilitation, Chuzan Hospital, 6-2-1 Matsumoto, Okinawa 904-2151, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Murotani', 'Affiliation': 'Biostatistics Center, Kurume University, 67 Asahimachi, Kurume 830-0011, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Ueshima', 'Affiliation': 'Department of Clinical Nutrition and Food Service, NTT Medical Center Tokyo, 5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo 141-8625, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Shimizu', 'Affiliation': 'Department of Nutrition, Hamamatsu City Rehabilitation Hospital, 1-6-1 Wago-kita, Naka-ku, Hamamatsu, Shizuoka 433-8127, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata 950-3198, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Okinawa Chuzan Hospital Clinical Research Center, Chuzan Hospital, 6-2-1 Matsumoto, Okinawa 904-2151, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Suenaga', 'Affiliation': 'Department of Rehabilitation Medicine, Chuzan Hospital, 6-2-1 Matsumoto, Okinawa 904-2151, Japan.'}, {'ForeName': 'Yuria', 'Initials': 'Y', 'LastName': 'Ishida', 'Affiliation': 'Department of Nutrition, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan.'}, {'ForeName': 'Naoharu', 'Initials': 'N', 'LastName': 'Mori', 'Affiliation': 'Department of Palliative and Supportive Medicine, Graduate School of Medicine, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan.'}]",Nutrients,['10.3390/nu12103104']
3168,33053728,Effect of Psycho-Regulatory Massage Therapy on Pain and Depression in Women with Chronic and/or Somatoform Back Pain: A Randomized Controlled Trial.,"Chronic unspecific back pain (cBP) is often associated with depressive symptoms, negative body perception, and abnormal interoception. Given the general failure of surgery in cBP, treatment guidelines focus on conservative therapies. Neurophysiological evidence indicates that C-tactile fibers associated with the oxytonergic system can be activated by slow superficial stroking of the skin in the back, shoulder, neck, and dorsal limb areas. We hypothesize that, through recruitment of C-tactile fibers, psycho-regulatory massage therapy (PRMT) can reduce pain in patients with cBP. In our study, 66 patients were randomized to PRMT or CMT (classical massage therapy) over a 12-week period and tested by questionnaires regarding pain (HSAL= Hamburger Schmerz Adjektiv Liste; Hamburg Pain adjective list), depression (BDI-II = Beck depression inventory), and disability (ODI = Oswestry Disability Index). In all outcome measures, patients receiving PRMT improved significantly more than did those receiving CMT. The mean values of the HSAL sensory subscale decreased by -51.5% in the PRMT group compared to -6.7% in the CMT group. Depressive symptoms were reduced by -55.69% (PRMT) and -3.1% (CMT), respectively. The results suggest that the superiority of PRMT over CMT may rely on its ability to activate the C-tactile fibers of superficial skin layers, recruiting the oxytonergic system.",2020,"Depressive symptoms were reduced by -55.69% (PRMT) and -3.1% (CMT), respectively.","['Chronic unspecific back pain (cBP', '66 patients', 'patients with cBP', 'Women with Chronic and/or Somatoform Back Pain']","['Psycho-Regulatory Massage Therapy', 'psycho-regulatory massage therapy (PRMT', 'PRMT or CMT (classical massage therapy', 'PRMT']","[' Beck depression inventory), and disability (ODI = Oswestry Disability Index', 'patients receiving PRMT', 'mean values of the HSAL sensory subscale', 'Pain and Depression', 'pain (HSAL= Hamburger Schmerz Adjektiv Liste; Hamburg Pain adjective list), depression (BDI-II', 'Depressive symptoms']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",66.0,0.0581292,"Depressive symptoms were reduced by -55.69% (PRMT) and -3.1% (CMT), respectively.","[{'ForeName': 'Sabine B-E', 'Initials': 'SB', 'LastName': 'Baumgart', 'Affiliation': 'Faculty of Medicine, Institute for Health and Nursing Sciences, Martin Luther University Halle-Wittenberg, 06108 Halle, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Baumbach-Kraft', 'Affiliation': 'M.Sc. Public Health, 24105 Kiel, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Lorenz', 'Affiliation': 'Department of Biomedical Engineering, Faculty of Life Science, University of Applied Sciences, 21033-Hamburg, Germany.'}]",Brain sciences,['10.3390/brainsci10100721']
3169,33063308,"[The ""UPGRADE"" Study Protocol: Creative Strengthening Groups as an Innovative Preventive Intervention for Healthcare Workers].","Health care workers are subjected to particular job strains. Besides workload, exposure to the risks of violence and traumatic experiences can result in negative health effects. To date, there are hardly any preventive interventions. Supported by the German Innovationsfonds, we want to evaluate the effectiveness of a more intensive intervention for health care workers, the Creative Strengthening Groups. In this randomised controlled trial, 366 participants will be assigned to the intervention or the control group. The intervention group will participate in the Creative Strengthening Groups. At baseline and follow-up, all participants will complete questionnaires. The primary outcome is the change in job satisfaction as measured with the validated Copenhagen Psychosocial Questionnaire (COPSOQ). Secondary outcomes will be obtained by questionnaires that include items on psychosocial working conditions and organisational changes. We hypothesise that participation in the UPGRADE intervention will improve job satisfaction and thus constitute a structural and behavioural prevention strategy for the promotion of psychological well-being of health care workers.",2020,We hypothesise that participation in the UPGRADE intervention will improve job satisfaction and thus constitute a structural and behavioural prevention strategy for the promotion of psychological well-being of health care workers.,"['Healthcare Workers', '366 participants']",[],"['psychosocial working conditions and organisational changes', 'change in job satisfaction as measured with the validated Copenhagen Psychosocial Questionnaire (COPSOQ']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",[],"[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",366.0,0.0453915,We hypothesise that participation in the UPGRADE intervention will improve job satisfaction and thus constitute a structural and behavioural prevention strategy for the promotion of psychological well-being of health care workers.,"[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pieper', 'Affiliation': 'Institut für Medizinische Informatik, Biometrie und Epidemiologie, Universitätsklinikum Essen.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schröer', 'Affiliation': 'Institut für Medizinische Informatik, Biometrie und Epidemiologie, Universitätsklinikum Essen.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Spanier', 'Affiliation': 'Institut für Medizinische Informatik, Biometrie und Epidemiologie, Universitätsklinikum Essen.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Psychotherapie und Neurologie, Klinik für Psychiatrie, Helios Marien Klinik Duisburg.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Russ', 'Affiliation': 'Prävention, Novitas BKK, Duisburg.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Baer', 'Affiliation': 'ISI - Trauma, ISI - Institut für soziale Innovationen, Duisburg.'}]","Psychotherapie, Psychosomatik, medizinische Psychologie",['10.1055/a-1248-2412']
3170,33064039,Auditory and visual distraction improve muscle endurance: a randomised controlled trial.,"The main aim was to investigate the influence of various distracting stimuli on the endurance-strength and fatigue of the lumbar region in asymptomatic participants. Fifty-four healthy individuals were randomised to three groups: auditory distraction group (ADG), visual distraction group (VDG) and control group without distraction (CG). Lumbar muscle endurance and perceived fatigue were the outcome measures. Lumbar muscle endurance was assessed with the Biering-Sorensen test, and perceived fatigue was assessed with the modified Borg scale, once baseline and second with the distraction intervention. Lumbar muscle endurance showed significant changes over time, and there were intragroup differences for VDG and ADG. The direct comparison did show significant differences between both distraction groups with respect to the control group with a large effect size (ΔVDG-CG: p < 0.001, d = 1.55 and, ΔADG-CG: p = 0.008, d = 1.07) but not between the two distraction groups (ΔVDG-VDG: p = 0.56). Fatigue showed significant changes over time but not for group*time interaction, revealing intragroup differences for VDG and ADG. There were no intragroup differences in the CG for muscle resistance or fatigue, and there were no between-group differences. Auditory and visual distractors might produce a significant increase in muscle resistance during the Biering-Sorensen test. Both techniques are valid for increasing lumbar muscle endurance but also both stimuli produced a higher level of fatigue or perception of effort once the test was completed when compared with CG. Finally, we were unable to demonstrate that one type of stimulus produces superior results to the other.",2020,Both techniques are valid for increasing lumbar muscle endurance but also both stimuli produced a higher level of fatigue or perception of effort once the test was completed when compared with CG.,"['asymptomatic participants', 'Fifty-four healthy individuals']","['Auditory and visual distraction', 'auditory distraction group (ADG), visual distraction group (VDG) and control group without distraction (CG']","['Lumbar muscle endurance and perceived fatigue', 'muscle resistance', 'lumbar muscle endurance', 'muscle endurance', 'muscle resistance or fatigue', 'Lumbar muscle endurance']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",54.0,0.0270395,Both techniques are valid for increasing lumbar muscle endurance but also both stimuli produced a higher level of fatigue or perception of effort once the test was completed when compared with CG.,"[{'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Grande-Alonso', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ortega-López', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Vittecoq', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Mayo-Fernández', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Navarro-Fernández', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cuenca-Martínez', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'La Touche', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Paris-Alemany', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}]",Somatosensory & motor research,['10.1080/08990220.2020.1834378']
3171,33064057,Efficacy and Safety of Aqueous Interleukin-8-Guided Treatment in Cytomegalovirus Retinitis after Bone Marrow Hematopoietic Stem Cell Transplantation.,"PURPOSE
To explore the optimal treatment for cytomegalovirus retinitis (CMVR) in patients status-post Allogeneic bone marrow hematopoietic stem cell transplantation (Allo-HSCT), based on aqueous humor indicators.
METHODS
A randomized controlled study with 35 eyes. Eyes were randomized with a 1:1 ratio to standard treatment group (Group 1, with treatment endpoint as aqueous CMV-DNA load＜10 3 copy/ml), and interleukin (IL)-8 group (Group 2, with treatment endpoint as aqueous IL-8 level ＜30 pg/ml or CMV-DNA load＜10 3 copy/ml) to receive antiviral intravitreal injections. Number of injections, CMVR recurrence rate, complication rate, and vision changes were analyzed and compared.
RESULTS
The mean number of injections in group 2 was less than in group 1 (6 vs 8 respectively, p <0.05). There were no significant differences in CMVR recurrence, complication and vision recovery rate.
CONCLUSION
Incorporating aqueous humor IL-8 level into the criteria of CMVR treatment decision can safely and effectively reduce the number of intravitreal injections needed and can be used as important indicators to assess treatment endpoint.",2020,"The mean number of injections in group 2 was less than in group 1 (6 vs 8 respectively, p <0.05).","['Cytomegalovirus Retinitis after Bone Marrow Hematopoietic Stem Cell Transplantation', '35 eyes', 'cytomegalovirus retinitis (CMVR) in patients status-post Allogeneic bone marrow hematopoietic stem cell transplantation (Allo-HSCT']","['antiviral intravitreal injections', 'aqueous CMV-DNA load＜103 copy/ml), and interleukin (IL)-8 group (Group 2, with treatment endpoint as aqueous IL-8 level ＜30 pg/ml or CMV-DNA', 'Aqueous Interleukin-8-Guided Treatment']","['Number of injections, CMVR recurrence rate, complication rate, and vision changes', 'mean number of injections', 'CMVR recurrence, complication and vision recovery rate', 'Efficacy and Safety']","[{'cui': 'C0206178', 'cui_str': 'Cytomegaloviral retinitis'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0449437', 'cui_str': 'Patient status'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0369083', 'cui_str': 'Cytomegalovirus DNA'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0206178', 'cui_str': 'Cytomegaloviral retinitis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",35.0,0.0661497,"The mean number of injections in group 2 was less than in group 1 (6 vs 8 respectively, p <0.05).","[{'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Ophthalmology & Clinical Centre of Optometry, Peking University People's Hospital, Eye Diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroidal Diseases, College of Optometry, Peking University Health Science Center , Beijing, China.""}, {'ForeName': 'Ye Elaine', 'Initials': 'YE', 'LastName': 'Wang', 'Affiliation': 'Harvard Eye Associates, Private Practice , Laguna Hills, CA, USA.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': ""Department of Ophthalmology & Clinical Centre of Optometry, Peking University People's Hospital, Eye Diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroidal Diseases, College of Optometry, Peking University Health Science Center , Beijing, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': ""Department of Ophthalmology & Clinical Centre of Optometry, Peking University People's Hospital, Eye Diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroidal Diseases, College of Optometry, Peking University Health Science Center , Beijing, China.""}]",Ocular immunology and inflammation,['10.1080/09273948.2020.1823422']
3172,33038782,Effects of chamomile extract nasal drop on chronic rhinosinusitis treatment: A randomized double blind study.,"OBJECTIVES
Recently, more attention has been paid to herbal treatment in chronic rhinosinusitis (CRS) patients. Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties. This study aimed to evaluate the effects of chamomile extract on the clinical symptoms of patients with CRS in a university hospital.
MATERIALS AND METHODS
In a randomized double-blind placebo-group clinical trial, 74 CRS patients were examined by an otolaryngologist blinded to the study groups, and the effects of treatment (according to SNOT-22 questionnaire) and possible complications recorded. Statistical analysis performed using SPSS software version 21, and level of significance considered as P < 0.05.
RESULTS
Of the 74 patients (31 females and 43 male), 37 cases randomized in the intervention and 37 cases in the placebo group. The Lund-Mackay score, clinical findings in endoscopic nasal examination and mean score of the SNOT-22 were not significantly different at baseline visit between the two study groups. The adjusted mean score of quality of life during the four time periods in the intervention group (34.3, confidence interval of 95%: 31.8-36.7) was significantly lower than that of control group (45.9, confidence interval of 95%: 43.5-48.4) (P-value = 0.001). Also, clinical improvement in endoscopic nasal examination was significant in intervention group compared with placebo group.
CONCLUSION
Chamomile extract is effective in further reducing the clinical symptoms and improving the quality of life of CRS patients.",2020,Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties.,"['74 CRS patients', '74 patients (31 females and 43 male', 'patients with CRS in a university hospital', 'chronic rhinosinusitis treatment', 'chronic rhinosinusitis (CRS) patients']","['chamomile extract nasal drop', 'Chamomile (Matrricaria chamomilla', 'chamomile extract', 'placebo', 'Chamomile extract']","['adjusted mean score of quality of life', 'Lund-Mackay score, clinical findings in endoscopic nasal examination and mean score of the SNOT-22', 'endoscopic nasal examination', 'quality of life']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439963', 'cui_str': 'Chamomile extract'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}]",74.0,0.418448,Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties.,"[{'ForeName': 'Shadman', 'Initials': 'S', 'LastName': 'Nemati', 'Affiliation': 'Otorhinolaryngology Research Center, Department of Otolaryngology and Head and Neck Surgery, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Yousefbeyk', 'Affiliation': 'Department of Pharmacognosy, School of Pharmacy, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Seyedeh Matin', 'Initials': 'SM', 'LastName': 'Ebrahimi', 'Affiliation': 'Otorhinolaryngology Research Center, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Ali Faghih', 'Initials': 'AF', 'LastName': 'FaghihHabibi', 'Affiliation': 'Otorhinolaryngology Research Center, Department of Otolaryngology and Head and Neck Surgery, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran. Electronic address: dr.faghih.habibi@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shakiba', 'Affiliation': 'Cardiovascular Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Hedieh', 'Initials': 'H', 'LastName': 'Ramezani', 'Affiliation': 'Otorhinolaryngology Research Center, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102743']
3173,33044352,The Effect of Venlafaxine on Electrocardiogram Intervals During Treatment for Depression in Older Adults.,"PURPOSE/BACKGROUND
Venlafaxine is a commonly used antidepressant with both serotonergic and noradrenergic activity. There are concerns that it may prolong the corrected QT interval (QTc), and older adults may be at higher risk for this adverse effect, especially at higher dosages of the medication.
METHODS/PROCEDURES
In this secondary analysis of a prospective clinical trial, we measured changes in QTc and other electrocardiogram (ECG) parameters in 169 adults 60 years or older with a major depressive disorder treated acutely with venlafaxine extended release up to 300 mg daily. We examined the relationship of venlafaxine dosage and ECG parameters, as well as the relationship between serum levels of venlafaxine and ECG parameters.
FINDINGS/RESULTS
Venlafaxine exposure was not associated with an increase in QTc. Heart rate increased with venlafaxine treatment, whereas the PR interval shortened, and QRS width did not change significantly. The QTc change from baseline was not associated with venlafaxine dosages or serum concentrations. Age, sex, cardiovascular comorbidities, and depression remission status did not predict changes in QTc with venlafaxine.
IMPLICATIONS/CONCLUSIONS
Venlafaxine treatment did not prolong QTc or other ECG parameters, even in high dosages in older depressed adults. These findings indicate that venlafaxine does not significantly affect cardiac conduction in most older patients.",2020,"Heart rate increased with venlafaxine treatment, whereas the PR interval shortened, and QRS width did not change significantly.","['older depressed adults', 'Older Adults', 'older patients', 'extended release up to 300 mg daily', '169 adults 60 years or older with a major depressive disorder treated acutely with']","['Venlafaxine', 'venlafaxine']","['corrected QT interval (QTc', 'QTc', 'Electrocardiogram Intervals', 'Heart rate', 'cardiac conduction', 'PR interval shortened, and QRS width', 'QTc and other electrocardiogram (ECG) parameters']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0078569', 'cui_str': 'venlafaxine'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0520878', 'cui_str': 'Shortened PR interval'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",169.0,0.0214423,"Heart rate increased with venlafaxine treatment, whereas the PR interval shortened, and QRS width did not change significantly.","[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Behlke', 'Affiliation': 'From the Department of Psychiatry.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'From the Department of Psychiatry.'}, {'ForeName': 'Vy', 'Initials': 'V', 'LastName': 'Pham', 'Affiliation': 'From the Department of Psychiatry.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Division of Biostatistics.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Smith', 'Affiliation': 'Cardiovascular Division, Department of Medicine, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Yasmina', 'Initials': 'Y', 'LastName': 'Saade', 'Affiliation': 'Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Stefan', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001287']
3174,33044356,"Trazodone as an Alternative Treatment for Neuroleptic-Associated Akathisia: A Placebo-Controlled, Double-Blind, Clinical Trial.","BACKGROUND
Akathisia is a distressing extrapyramidal complication that follows the use of antipsychotic medications. Early treatment of neuroleptic-associated akathisia (NAA) is of great importance because it may lead to poor therapeutic response and ultimately treatment noncompliance. Considering the lack of adequate response of some patients to conventional treatments and the assumption that serotonin might be involved in the pathophysiology of the disease in addition to dopaminergic mechanisms, we aimed to evaluate the effectiveness of trazodone as an antidepressant agent with strong antagonistic effects on serotonin receptors in the treatment of akathisia.
METHODS
In a double-blind clinical trial, 52 patients receiving antipsychotic medications who were diagnosed to have mild to severe NAA using Barnes Akathisia Rating Scale were treated with trazodone 50 mg daily for 5 days and compared with the placebo control group.
RESULTS
Patients receiving trazodone did not show a significant difference compared with the control group in terms of the severity of akathisia symptoms until the third day of the study. In contrast, at the end of the fifth day, there was a significant improvement in objective (P = 0.01) and subjective (P = 0.001) symptoms of akathisia and the global clinical assessment of akathisia scale (P = 0.001). Moreover, there was no clear difference between trazodone and placebo group in terms of adverse effects.
CONCLUSIONS
Considering the antagonistic effect of trazodone on postsynaptic 5-hydroxytryptamine2A receptors as a possible mechanism of efficacy of this agent in the treatment of NAA, this study suggests that trazodone might be an effective and relatively safe drug.",2020,"RESULTS
Patients receiving trazodone did not show a significant difference compared with the control group in terms of the severity of akathisia symptoms until the third day of the study.",['52 patients receiving antipsychotic medications who were diagnosed to have mild to severe NAA using Barnes Akathisia Rating Scale'],"['placebo control group', 'placebo', 'neuroleptic-associated akathisia (NAA', 'trazodone', 'Trazodone', 'Placebo']","['symptoms of akathisia and the global clinical assessment of akathisia scale', 'adverse effects', 'severity of akathisia symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",52.0,0.0935611,"RESULTS
Patients receiving trazodone did not show a significant difference compared with the control group in terms of the severity of akathisia symptoms until the third day of the study.","[{'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Shams-Alizadeh', 'Affiliation': 'From the Neurosciences Research Center.'}, {'ForeName': 'Azad', 'Initials': 'A', 'LastName': 'Maroufi', 'Affiliation': 'From the Neurosciences Research Center.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Asadi', 'Affiliation': 'Departments of Psychiatry.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Rahmani', 'Affiliation': 'Community Medicine.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Hassanzadeh', 'Affiliation': 'From the Neurosciences Research Center.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001286']
3175,33039508,Using behavioural insights to reduce sugar in primary school children's packed lunches in derby; A cluster randomised controlled trial.,"Children's packed lunches contain more sugar than school-provided meals. Interventions to improve the provision of healthier packed lunches have modest effects on lunch contents. This cluster randomised controlled trial tested an intervention to encourage healthier provision of packed lunches by parents of primary school children in Derby. Schools were randomised to intervention (n = 8) or control (n = 9) using blocked random allocation. In the intervention group, parents of children who brought packed lunches to school in years 3-6 (age 7-11 years) received three bundles of materials (including packed lunch planner, shopping list, information on sugar content of popular lunchbox items and suggestions for healthier swap alternatives) in bookbags/lunchboxes over a 4-week period. Control parents received no materials. Photos of lunchbox contents were taken at baseline, immediately post-intervention and at three-month follow-up. A parental survey aimed to assess capability, opportunity and motivation for packing a healthier lunchbox. No intervention effects were observed for primary outcomes (presence and number of sugary snacks or chilled sugary desserts). The intervention had a significant impact on one secondary outcome (increased number of healthier ""swap"" items suggested in intervention materials) immediately post-intervention, but this effect had disappeared at three-month follow-up. No intervention effects were found on survey variables. Parent comments revealed that materials were either received positively (as they reinforced existing behaviours) or negatively (as they were not perceived to be helpful or appropriate). The results of this study suggest that providing educational materials and resources to parents of primary school children in Derby was not sufficient to increase provision of healthier packed lunches. Future research should investigate how behavioural science can support families to improve the nutritional content of primary school children's lunchboxes.",2020,This cluster randomised controlled trial tested an intervention to encourage healthier provision of packed lunches by parents of primary school children in Derby.,"['packed lunches by parents of primary school children in Derby', ""primary school children's packed lunches in Derby"", 'parents of children who brought packed lunches to school in years 3-6 (age 7-11 years) received', ""primary school children's lunchboxes""]","['three bundles of materials (including packed lunch planner, shopping list, information on sugar content of popular lunchbox items and suggestions for healthier swap alternatives) in bookbags/lunchboxes']","['number of healthier ""swap"" items', 'primary outcomes (presence and number of sugary snacks or chilled sugary desserts']","[{'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332302', 'cui_str': 'Brought on by'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0453505', 'cui_str': 'Dessert'}]",,0.0360658,This cluster randomised controlled trial tested an intervention to encourage healthier provision of packed lunches by parents of primary school children in Derby.,"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bunten', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Porter', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK. Electronic address: L.Porter@exeter.ac.uk.'}, {'ForeName': 'Jilla', 'Initials': 'J', 'LastName': 'Burgess-Allen', 'Affiliation': 'Derby City Council, Council House, Corporation Street, Derby, DE1 2FS, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Howell-Jones', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Jackson', 'Affiliation': 'University of Derby, Kedleston Road, Derby, DE22 1GB, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Ward', 'Affiliation': 'Medical School, University of Lincoln, Brayford Way, Brayford Pool, Lincoln, LN6 7TS, UK; Public Health Division, Adult Care and Community Wellbeing, Lincolnshire County Council, County Offices, Newland, Lincoln, LN1 1YL, UK.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Staples', 'Affiliation': 'University of Derby, Kedleston Road, Derby, DE22 1GB, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Staples', 'Affiliation': 'University of Derby, Kedleston Road, Derby, DE22 1GB, UK.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Rowthorn', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK; Department of Psychology, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Ayoub', 'Initials': 'A', 'LastName': 'Saei', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'van Schaik', 'Affiliation': 'School of Social Sciences and Law, Teesside University, Campus Heart, Southfield Rd, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tydeman', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Blair', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'Hugueniot', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Gold', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chadborn', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}]",Appetite,['10.1016/j.appet.2020.104987']
3176,33039650,"Derepression of glomerular filtration, renal blood flow and antioxidant defence in patients with type 2 diabetes at high-risk of cardiorenal disease.","BACKGROUND
The role of antioxidant status on microvascular blood flow and glomerular filtration (eGFR) in patients with type 2 diabetes and hypertension whose risk of progressive renal disease varies by ethnicity is unknown.
METHODS
Adult, non-Caucasian (n = 101) and Caucasian (n = 69) patients with type 2 diabetes, hypertension and/or microalbuminuria and an eGFR > 45 mL/min/1.73 m 2 were randomised to receive 400 IU vitamin E and/or 20 μg selenium daily or matching placebo. eGFR (CKD-EPI) was measured at baseline, 3,6 and 12 months and renal blood flow by contrast-enhanced ultrasonography in a sub-group (n = 9) at baseline and 3 months by assessing the area under the time intensity curve (TIC). Circulating glutathione peroxidase 3 (GPx-3) activity was measured as a biomarker of oxidative defence status.
RESULTS
The time to change in eGFR was shortest with combined vitamin E and selenium than usual care (5.6 [4.0-7.0] vs 8.9 [6.8-10.9 months]; p = 0.006). Area under the TIC was reduced compared to baseline (38.52 [22.41-90.49] vs 123 [86.98-367.03]dB.s; P ≤ 0.05 and 347 [175.88-654.92] vs 928.03 [448.45-1683]dB.s; P ≤ 0.05, respectively] at 3 months suggesting an increase in rate of perfusion. The proportional change in eGFR at 12 months was greater in the group whose GPx-3 activity was above, compared with those below the cohort median (360 U/L) in the non-Caucasian and the Caucasian groups (19.1(12.5-25.7] % vs 6.5[-3.5 to 16.5] % and 12.8 [0.7 to 24] % vs 0.2 [-6.1 to 6.5] %).
CONCLUSION
In these patients with type 2 diabetes and early CKD, antioxidant treatment derepresses renal blood flow and a rise in eGFR correlated directly with GPx-3 activity.
SIGNIFICANCE
Diabetes mellitus is the world's leading cause of end-stage renal disease which has a predilection for black and minor ethnic groups compared with Caucasians. The differences in risk despite the benefits of conventional care may be related to oxidative stress. We found that glomerular filtration and renal blood flow is suppressed when renal function is preserved in high-risk patients with type 2 diabetes. Conventional care supplemented with selenium - the co-factor for glutathione peroxidase-3 (GPx-3) - improves renal perfusion and increase glomerular filtration according to host antioxidant defence determined by GPx-3 activity. Circulating GPx-3 activity warrants further investigation as a novel biomarker of reversible haemodynamic changes in early diabetic kidney disease to better enable targeting of renoprotective strategies.",2020,"Area under the TIC was reduced compared to baseline (38.52 [22.41- 90.49] vs 123 [86.98- 367.03]dB.s; P≤0.05 and 347 [175.88- 654.92] vs 928.03 [448.45-1683]dB.s; P≤0.05, respectively] at 3 months suggesting an increase in rate of perfusion.","['patients with type 2 diabetes at high-risk of cardiorenal disease', 'patients with type 2 diabetes and hypertension whose risk of progressive renal disease varies by ethnicity', 'high-risk patients with type 2 diabetes', 'Adult, non-Caucasian (n=101) and Caucasian (n=69) patients with type 2 diabetes, hypertension and/or microalbuminuria and an eGFR > 45 mL/min/1.73m 2', 'Diabetes mellitus']","['selenium daily or matching placebo', 'combined vitamin E and selenium', 'Conventional care supplemented with selenium - the co-factor for glutathione peroxidase-3 (GPx-3) ', '400 IU vitamin E']","['glomerular filtration and renal blood flow', 'renal blood flow and glomerular filtration', 'microvascular blood flow and glomerular filtration (eGFR', 'eGFR (CKD-EPI', 'rate of perfusion', 'Circulating glutathione peroxidase 3 (GPx-3) activity', 'renal blood flow', 'GPx-3 activity', 'proportional change in eGFR', 'time to change in eGFR', 'Derepression of glomerular filtration, renal blood flow and antioxidant defence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0155601', 'cui_str': 'Hypertensive heart AND renal disease'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1436542', 'cui_str': 'GPX3 protein, human'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0035070', 'cui_str': 'Circulation, Renal'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C1436542', 'cui_str': 'GPX3 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",,0.0397352,"Area under the TIC was reduced compared to baseline (38.52 [22.41- 90.49] vs 123 [86.98- 367.03]dB.s; P≤0.05 and 347 [175.88- 654.92] vs 928.03 [448.45-1683]dB.s; P≤0.05, respectively] at 3 months suggesting an increase in rate of perfusion.","[{'ForeName': 'Karima', 'Initials': 'K', 'LastName': 'Zitouni', 'Affiliation': 'St Georges University of London, Institute of Infection and Immunity, London, UK.'}, {'ForeName': 'M R C P', 'Initials': 'MRCP', 'LastName': 'Steyn', 'Affiliation': 'St Georges University Hospitals NHS Foundation Trust, Thomas Addison Unit, London, UK.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Lyka', 'Affiliation': 'St Georges University of London, Institute of Biomedical & Medical Education, London, UK.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Kelly', 'Affiliation': 'Kings College London, Analytical, Environmental and Forensic Sciences Department, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cook', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Trace Element Unit, Southampton, UK.'}, {'ForeName': 'Irina Chis', 'Initials': 'IC', 'LastName': 'Ster', 'Affiliation': 'St Georges University of London, Institute of Infection and Immunity, London, UK.'}, {'ForeName': 'Kenneth Anthony', 'Initials': 'KA', 'LastName': 'Earle', 'Affiliation': 'St Georges University Hospitals NHS Foundation Trust, Thomas Addison Unit, London, UK; St Georges University of London, Institute of Biomedical & Medical Education, London, UK. Electronic address: kearle@sgul.ac.uk.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.10.005']
3177,33039658,Randomised comparison of Enk™ and Manujet™ for emergency tracheal oxygenation with a high-fidelity full-scale simulation.,"BACKGROUND
We aimed to compare time and difficulties of emergency tracheal oxygenation with Enk™ or Manujet™ by anaesthesiologists or intensivists, in a full-scale cannot ventilate and intubate scenarios on a SimMan3G™ high-fidelity patient simulator.
METHODS
After ethical committee approval and written informed consent, teams (two to three learners with at least one physician senior) participating at a difficult airway training with a massive sublingual haematoma scenario, were randomised in Enk™ (E) group (29 teams, 76 learners) and Manujet™ (M) group (31 teams, 84 learners) according to the device at disposal. Main criterion was time between taking device in hand and first insufflation delay. Data were medians [25-75%].
RESULTS
The handling-insufflation time was shorter with Enk™ than with Manujet™ (74 [54-87] seconds versus 95 [73-123] seconds (s), P=0.0112). The team number performing insufflation within one minute after device handling was higher in the E group (8, 27.6%) than in the M group (2, 6.4%) (P=0.0392) as well as the team number performing insufflation within 90s in the E group (22, 75.09%) than in the M group (12, 38.7%) (P=0.0047). In E group, 75% of learners reported no difficulty versus 58.8% in M group (P=0.0443). Insufflation frequency was high in both groups and higher than 12min -1 in 51.7% of the teams.
CONCLUSION
In a simulation context, Enk™ use is faster and easier. A high insufflation rate was also in favour of Enk™ that generates lower airway pressures.",2020,"In E group, 75% of learners reported no difficulty versus 58.8% in M group (P=0.0443).",['teams (two to three learners with at least one physician senior) participating at a difficult airway training with a massive sublingual haematoma scenario'],"['emergency tracheal oxygenation with Enk™ or Manujet™ by anaesthesiologists or intensivists', 'Enk™ and Manujet™ for emergency tracheal oxygenation']","['Insufflation frequency', 'handling-insufflation time']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}]","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C2945595', 'cui_str': 'Tracheal'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018578', 'cui_str': 'Handling (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0795779,"In E group, 75% of learners reported no difficulty versus 58.8% in M group (P=0.0443).","[{'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Lejus-Bourdeau', 'Affiliation': ""Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu - Hôpital Mère Enfant, CHU Nantes, Place Alexis Ricordeau, F-44093 Nantes, France; Laboratoire Expérimental de Simulation de Médecine Intensive de l'Université (LE SiMU) de Nantes, 9, rue Bias, 44001 Nantes, France. Electronic address: corinne.lejus@chu-nantes.fr.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Grillot', 'Affiliation': ""Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu - Hôpital Mère Enfant, CHU Nantes, Place Alexis Ricordeau, F-44093 Nantes, France; Laboratoire Expérimental de Simulation de Médecine Intensive de l'Université (LE SiMU) de Nantes, 9, rue Bias, 44001 Nantes, France.""}, {'ForeName': 'Ségolène', 'Initials': 'S', 'LastName': 'Dupont', 'Affiliation': ""Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu - Hôpital Mère Enfant, CHU Nantes, Place Alexis Ricordeau, F-44093 Nantes, France; Laboratoire Expérimental de Simulation de Médecine Intensive de l'Université (LE SiMU) de Nantes, 9, rue Bias, 44001 Nantes, France.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Robert-Edan', 'Affiliation': ""Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu - Hôpital Mère Enfant, CHU Nantes, Place Alexis Ricordeau, F-44093 Nantes, France; Laboratoire Expérimental de Simulation de Médecine Intensive de l'Université (LE SiMU) de Nantes, 9, rue Bias, 44001 Nantes, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bazin', 'Affiliation': ""Laboratoire Expérimental de Simulation de Médecine Intensive de l'Université (LE SiMU) de Nantes, 9, rue Bias, 44001 Nantes, France.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Viquesnel', 'Affiliation': ""Laboratoire Expérimental de Simulation de Médecine Intensive de l'Université (LE SiMU) de Nantes, 9, rue Bias, 44001 Nantes, France; Pôle Anesthésie Réanimation, CHU Rennes, 2, rue Henri Le Guilloux, 35033 Rennes cedex 9, France.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Pichenot', 'Affiliation': ""Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu - Hôpital Mère Enfant, CHU Nantes, Place Alexis Ricordeau, F-44093 Nantes, France; Laboratoire Expérimental de Simulation de Médecine Intensive de l'Université (LE SiMU) de Nantes, 9, rue Bias, 44001 Nantes, France.""}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.01.011']
3178,33045193,Home-based oral self-testing for absent and declining individuals during a door-to-door HIV testing campaign in rural Lesotho (HOSENG): a cluster-randomised trial.,"BACKGROUND
In sub-Saharan Africa, home-based HIV testing is validated and accepted, but coverage is low because household members are often absent during home-based testing campaigns. We aimed to measure the effect of a secondary distribution of oral-fluid HIV self-tests on coverage during home-based testing in rural Lesotho.
METHODS
The Home-Based Self-Testing (HOSENG) trial was a cluster-randomised, non-blinded superiority trial in rural villages in the catchment area of 20 health facilities of two districts in Lesotho (Butha-Buthe and Mokhotlong). Eligible villages had a consenting village chief and at least one registered village health worker; eligible households had a consenting representative aged 18 years or older. The HOSENG trial provided a recruitment platform for the interlinked Village-Based Refill of Antiretroviral Therapy (VIBRA) trial. Villages were randomly assigned 1:1:1:1 with block sizes of four to one of four groups: VIBRA control and HOSENG control; VIBRA control and HOSENG intervention; VIBRA intervention and HOSENG control; and VIBRA intervention and HOSENG intervention. Randomisation was stratified by district, village size, and access to the nearest health facility. An independent statistician was responsible for the computer-generated randomisation list. In the intervention group, oral-fluid HIV self-tests were left for absent or declining household members (aged ≥12 years) during a home visit from the HIV testing campaign team. One present household member was trained on self-test use. Distributed self-tests were followed up by village health workers. In control village clusters, absent or declining household members were referred to the clinic for HIV testing. The primary outcome was HIV testing coverage among all household members aged 12 years or older within 120 days, defined as a confirmed HIV test result or known status, reported in testing registers at the health facilities or on the follow-up forms of the village health worker. Adjusted random-effects logistic regression with individuals as the unit of analysis was used. This trial is registered with ClinicalTrials.gov, NCT03598686.
FINDINGS
Between July 26, 2018, and Dec 12, 2018, 3091 consenting households with 7816 household members aged 12 years or older were enrolled and randomly assigned (intervention: 57 village clusters, 1620 households, 4174 household members; control: 49 village clusters, 1471 households, 3642 household members). In the control group, 38 (3%) of 1455 initially absent or declining household members tested at a clinic within 120 days. In the intervention group, 841 (53%) of 1601 initially absent or declining household members had a confirmed status within 120 days; 12 (1%) of 841 tested at the clinic and 829 (99%) used their self-test kit. This resulted in a testing coverage of 2201 (60%) of 3642 in the control group versus 3386 (81%) of 4174 in the intervention group (odds ratio 3·00 [95% CI 2·52-3·59]; p<0·0001).
INTERPRETATION
Secondary distribution of oral-fluid HIV self-tests during home-based testing increases testing coverage substantially and thus presents a promising add-on during testing campaigns.
FUNDING
Swiss National Science Foundation.",2020,"This resulted in a testing coverage of 2201 (60%) of 3642 in the control group versus 3386 (81%) of 4174 in the intervention group (odds ratio 3·00 [95% CI 2·52-3·59]; p<0·0001).
","['Between July 26, 2018, and Dec 12, 2018, 3091 consenting households with 7816 household members aged 12 years or older were enrolled and randomly assigned (intervention: 57 village clusters, 1620 households, 4174 household members; control: 49 village clusters, 1471 households, 3642 household members', 'rural villages in the catchment area of 20 health facilities of two districts in Lesotho (Butha-Buthe and Mokhotlong', 'rural Lesotho', 'Eligible villages had a consenting village chief and at least one registered village health worker; eligible households had a consenting representative aged 18 years or older']","['oral-fluid HIV self-tests', 'VIBRA control and HOSENG control; VIBRA control and HOSENG intervention; VIBRA intervention and HOSENG control; and VIBRA intervention and HOSENG intervention']",['HIV testing coverage'],"[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0023376', 'cui_str': 'Lesotho'}, {'cui': 'C0087157', 'cui_str': 'Village Health Worker'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}]",,0.134167,"This resulted in a testing coverage of 2201 (60%) of 3642 in the control group versus 3386 (81%) of 4174 in the intervention group (odds ratio 3·00 [95% CI 2·52-3·59]; p<0·0001).
","[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Amstutz', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; Department of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Thabo Ishmael', 'Initials': 'TI', 'LastName': 'Lejone', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Lefu', 'Initials': 'L', 'LastName': 'Khesa', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Muhairwe', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Moniek', 'Initials': 'M', 'LastName': 'Bresser', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Vanobberghen', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Mathebe', 'Initials': 'M', 'LastName': 'Kopo', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Mpho', 'Initials': 'M', 'LastName': 'Kao', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Bienvenu Lengo', 'Initials': 'BL', 'LastName': 'Nsakala', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Katleho', 'Initials': 'K', 'LastName': 'Tlali', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klimkait', 'Affiliation': 'University of Basel, Basel, Switzerland; Molecular Virology, Department of Biomedicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Battegay', 'Affiliation': 'Department of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Niklaus Daniel', 'Initials': 'ND', 'LastName': 'Labhardt', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; Department of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland. Electronic address: n.labhardt@swisstph.ch.'}, {'ForeName': 'Tracy Renée', 'Initials': 'TR', 'LastName': 'Glass', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30233-2']
3179,33045195,Circulating profile of Activin-Follistatin-Inhibin Axis in women with hypothalamic amenorrhea in response to leptin treatment.,"BACKGROUND
Chronic energy deficiency observed in women that exercise strenuously affects reproductive function, often leading to hypothalamic amenorrhea (HA). In such conditions, hypoleptinemia and robust changes in the Activin-Follistatin-Inhibin Axis (AFI) are observed. Treatment with leptin restores menstruation in many (60% responders) but not all (40% non-responders) women, suggesting that leptin is not the only regulator of reproductive function related to energy balance. In this work, we aimed to identify differences in hormonal profiles between leptin responders and non-responders among women with HA, with particular focus on the AFI axis.
METHODS
AFI axis and reproductive hormones (LH, FSH, Estradiol, ΑΜΗ) were measured in blood in: a) An open-label interventional study, b) a randomized placebo-controlled trial, both investigating responders versus non-responders/women with HA treated with leptin.
RESULTS
Women with HA that responded to leptin treatment have higher circulating levels/peak values of Inhibin A, Estradiol (E2), higher LH/FSH ratio and a trend to lower AMH compared with non-responders.
CONCLUSIONS
Components of the AFI axis are associated with improvement of reproductive function in women with HA treated with leptin. ΑΜΗ may serve as a marker of ovarian recovery under HA treatment.",2020,"Treatment with leptin restores menstruation in many (60% responders) but not all (40% non-responders) women, suggesting that leptin is not the only regulator of reproductive function related to energy balance.","['women with HA, with particular focus on the AFI axis', 'responders versus non-responders/women with HA treated with leptin', 'women with HA treated with leptin', 'women with hypothalamic amenorrhea in response to leptin treatment']",['placebo'],"['circulating levels/peak values of Inhibin A, Estradiol (E2), higher LH/FSH ratio', 'reproductive function', 'AFI axis and reproductive hormones (LH, FSH, Estradiol, ΑΜΗ']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0341862', 'cui_str': 'Hypothalamic amenorrhea'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0883157', 'cui_str': 'Inhibin A'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232896', 'cui_str': 'Reproductive function'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C1167871', 'cui_str': 'Reproductive hormone'}]",,0.0378645,"Treatment with leptin restores menstruation in many (60% responders) but not all (40% non-responders) women, suggesting that leptin is not the only regulator of reproductive function related to energy balance.","[{'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Bouzoni', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA. Electronic address: ebouzoni@bidmc.harvard.edu.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Perakakis', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA; Section of Endocrinology, VA Boston Healthcare System, Jamaica Plain, MA, USA.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154392']
3180,33050924,Home Treatment of Older People with Symptomatic SARS-CoV-2 Infection (COVID-19): A structured Summary of a Study Protocol for a Multi-Arm Multi-Stage (MAMS) Randomized Trial to Evaluate the Efficacy and Tolerability of Several Experimental Treatments to Reduce the Risk of Hospitalisation or Death in outpatients aged 65 years or older (COVERAGE trial).,"OBJECTIVES
To assess the efficacy of several repurposed drugs to prevent hospitalisation or death in patients aged 65 or more with recent symptomatic SARS-CoV-2 infection (COVID-19) and no criteria for hospitalisation.
TRIAL DESIGN
Phase III, multi-arm (5) and multi-stage (MAMS), randomized, open-label controlled superiority trial. Participants will be randomly allocated 1:1:1:1:1 to the following strategies: Arm 1: Control arm Arms 2 to 5: Experimental treatment arms Planned interim analyses will be conducted at regular intervals. Their results will be reviewed by an Independent Data and Safety Monitoring Board. Experimental arms may be terminated for futility, efficacy or toxicity before the end of the trial. New experimental arms may be added if new evidence suggests that other treatments should be tested. A feasibility and acceptability substudy as well as an immunological substudy will be conducted alongside the trial.
PARTICIPANTS
Inclusion criteria are: 65-year-old or more; Positive test for SARS-CoV-2 on a nasopharyngeal swab; Symptoms onset within 3 days before diagnosis; No hospitalisation criteria; Signed informed consent; Health insurance. Exclusion criteria are: Inability to make an informed decision to participate (e.g.: dementia, guardianship); Rockwood Clinical Frailty Scale ≥7; Long QT syndrome; QTc interval > 500 ms; Heart rate <50/min; Kalaemia >5.5 mmol/L or <3.5 mmol/L; Ongoing treatment with piperaquine, halofantrine, dasatinib, nilotinib, hydroxyzine, domperidone, citalopram, escitalopram, potent inhibitors or inducers of cytochrome P450 CYP3A4 isoenzyme, repaglinide, azathioprine, 6-mercaptopurine, theophylline, pyrazinamide, warfarin; Known hypersensitivity to any of the trial drugs or to chloroquine and other 4-aminoquinolines, amodiaquine, mefloquine, glafenine, floctafenine, antrafenine, ARB; Hepatic porphyria; Liver failure (Child-Pugh stage ≥B); Stage 4 or 5 chronic kidney disease (GFR <30 mL/min/1.73 m²); Dialysis; Hypersentivity to lactose; Lactase deficiency; Abnormalities in galactose metabolism; Malabsorption syndrome; Glucose-6-phosphate dehydrogenase deficiency; Symptomatic hyperuricemia; Ileus; Colitis; Enterocolitis; Chronic hepatitis B virus disease. The trial is being conducted in France in the Bordeaux, Corse, Dijon, Nancy, Paris and Toulouse areas as well as in the Grand Duchy of Luxembourg. Participants are recruited either at home, nursing homes, general practices, primary care centres or hospital outpatient consultations.
INTERVENTION AND COMPARATOR
The four experimental treatments planned in protocol version 1.2 (April 8 th , 2020) are: (1) Hydroxychloroquine 200 mg, 2 tablets BID on day 0, 2 tablets QD from day 1 to 9; (2) Imatinib 400 mg, 1 tablet QD from day 0 to 9; (3) Favipiravir 200 mg, 12 tablets BID on day 0, 6 tablets BID from day 1 to 9; (4) Telmisartan 20 mg, 1 tablet QD from day 0 to 9. The comparator is a complex of vitamins and trace elements (AZINC Forme et Vitalité®), 1 capsule BID for 10 days, for which there is no reason to believe that they are active on the virus. In protocol version 1.2 (April 8th, 2020): People in the control arm will receive a combination of vitamins and trace elements; people in the experimental arms will receive hydroxychloroquine, or favipiravir, or imatinib, or telmisartan.
MAIN OUTCOME
The primary outcome is the proportion of participants with an incidence of hospitalisation and/or death between inclusion and day 14 in each arm.
RANDOMISATION
Participants are randomized in a 1:1:1:1:1 ratio to each arm using a web-based randomisation tool. Participants not treated with an ARB or ACEI prior to enrolment are randomized to receive the comparator or one of the four experimental drugs. Participants already treated with an ARB or ACEI are randomized to receive the comparator or one of the experimental drugs except telmisartan (i.e.: hydroxychloroquine, imatinib, or favipiravir). Randomisation is stratified on ACEI or ARBs treatment at inclusion and on the type of residence (personal home vs. nursing home).
BLINDING (MASKING)
This is an open-label trial. Participants, caregivers, investigators and statisticians are not blinded to group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
A total of 1057 participants will be enrolled if all arms are maintained until the final analysis and no additional arm is added. Three successive futility interim analyses are planned, when the number of participants reaches 30, 60 and 102 in the control arm. Two efficacy analyses (interim n°3 and final) will be performed successively.
TRIAL STATUS
This describes the Version 1.2 (April 8 th , 2020) of the COVERAGE protocol that was approved by the French regulatory authority and ethics committee. The trial was opened for enrolment on April 15 th , 2020 in the Nouvelle Aquitaine region (South-West France). Given the current decline of the COVID-19 pandemic in France and its unforeseeable dynamic in the coming months, new trial sites in 5 other French regions and in Luxembourg are currently being opened. A revised version of the protocol was submitted to the regulatory authority and ethics committee on June 15 th , 2020. It contains the following amendments: (i) Inclusion criteria: age ≥65 replaced by age ≥60; time since first symptoms <3 days replaced by time since first symptoms <5 days; (ii) Withdrawal of the hydroxychloroquine arm (due to external data); (iii) increase in the number of trial sites.
TRIAL REGISTRATION
The trial was registered on Clinical Trials.gov on April 22 nd , 2020 (Identifier: NCT04356495): and on EudraCT on April 10 th , 2020 (Identifier: 2020-001435-27).
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"The primary outcome is the proportion of participants with an incidence of hospitalisation and/or death between inclusion and day 14 in each arm.
","['Participants not treated with an ARB or ACEI prior to enrolment', '1057 participants will be enrolled if all arms are maintained until the final analysis and no additional arm is added', 'patients aged 65 or more with recent symptomatic SARS-CoV-2 infection (COVID-19) and no criteria for hospitalisation', 'on April 10 th , 2020 (Identifier: 2020-001435-27', 'Inclusion criteria are: 65-year-old or more; Positive test for SARS-CoV-2 on a nasopharyngeal swab; Symptoms onset within 3 days before diagnosis', 'outpatients aged 65 years or older (COVERAGE trial', 'Older People with Symptomatic SARS-CoV-2 Infection (COVID-19', 'enrolment on April 15 th , 2020 in the Nouvelle Aquitaine region (South-West France', 'QT syndrome; QTc interval > 500 ms; Heart rate <50/min; Kalaemia >5.5 mmol/L or <3.5 mmol/L; Ongoing treatment with piperaquine, halofantrine, dasatinib, nilotinib', 'Participants already treated with an ARB or ACEI', 'Participants are recruited either at home, nursing homes, general practices, primary care centres or hospital outpatient consultations']","['hydroxychloroquine', 'hydroxyzine, domperidone, citalopram, escitalopram, potent inhibitors or inducers of cytochrome P450 CYP3A4 isoenzyme, repaglinide, azathioprine, 6-mercaptopurine, theophylline, pyrazinamide, warfarin', 'hydroxychloroquine, or favipiravir, or imatinib, or telmisartan', 'Hydroxychloroquine', 'chloroquine and other 4-aminoquinolines, amodiaquine, mefloquine, glafenine, floctafenine, antrafenine', 'Telmisartan', 'Multi-Arm Multi-Stage (MAMS', 'telmisartan (i.e.: hydroxychloroquine, imatinib, or favipiravir', 'EudraCT']","['proportion of participants with an incidence of hospitalisation and/or death', 'Risk of Hospitalisation or Death', 'Efficacy and Tolerability', 'hospitalisation or death', 'futility, efficacy or toxicity']","[{'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0120726', 'cui_str': 'halofantrine'}, {'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C1721377', 'cui_str': 'nilotinib'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0020404', 'cui_str': 'Hydroxyzine'}, {'cui': 'C0013015', 'cui_str': 'Domperidone'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0008381', 'cui_str': 'Cholesterol monooxygenase (side-chain cleaving)'}, {'cui': 'C1142644', 'cui_str': 'cytochrome P450 3A4 protein, human'}, {'cui': 'C0022173', 'cui_str': 'Isozymes'}, {'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0039771', 'cui_str': 'Theophylline'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0048060', 'cui_str': '4-aminoquinoline'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}, {'cui': 'C0017592', 'cui_str': 'glafenine'}, {'cui': 'C0016245', 'cui_str': 'floctafenine'}, {'cui': 'C0052135', 'cui_str': 'antrafenine'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086322', 'cui_str': 'Futility'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",1057.0,0.200195,"The primary outcome is the proportion of participants with an incidence of hospitalisation and/or death between inclusion and day 14 in each arm.
","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Duvignaud', 'Affiliation': 'CHU Bordeaux, Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, F-33000, Bordeaux, France. alexandre.duvignaud@chu-bordeaux.fr.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Lhomme', 'Affiliation': 'Univ. Bordeaux, Inserm, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Pistone', 'Affiliation': 'CHU Bordeaux, Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, F-33000, Bordeaux, France.'}, {'ForeName': 'Racha', 'Initials': 'R', 'LastName': 'Onaisi', 'Affiliation': 'Department of General Practice, Univ. Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Sitta', 'Affiliation': 'Univ. Bordeaux, Inserm, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Journot', 'Affiliation': 'Inserm U1219, Univ. Bordeaux, IRD, F-33000, Bordeaux, France.'}, {'ForeName': 'Duc', 'Initials': 'D', 'LastName': 'Nguyen', 'Affiliation': 'CHU Bordeaux, Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, F-33000, Bordeaux, France.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Peiffer-Smadja', 'Affiliation': 'CHU Bichat Claude Bernard, Department of Infectious Diseases and Tropical Medicine, APHP, F-75000, Paris, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Crémer', 'Affiliation': 'Department of Cardiology - Hypertension, CHU Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Bouchet', 'Affiliation': 'Inserm U1219, Univ. Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Darnaud', 'Affiliation': 'Centre Hospitalier de Bastia, Service de Chirurgie Spécialisée & Unité de Recherche Clinique, F-20200, Bastia, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Poitrenaud', 'Affiliation': ""Department of Infectious Diseases and Tropical Medicine, Centre Hospitalier d'Ajaccio, F-20090, Ajaccio, France.""}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Piroth', 'Affiliation': 'Department of Infectious Diseases and Tropical Medicine, CHU Dijon, F-21079, Dijon, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Binquet', 'Affiliation': 'Inserm, CHU Dijon, CIC-EC 1432, F-21000, Dijon, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Michel', 'Affiliation': 'Centre Medical de Steinsel, Steinsel, Luxembourg.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lefèvre', 'Affiliation': 'Department of Infectious Diseases and Tropical Medicine, CHU Nancy, F-54000, Nancy, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lebeaux', 'Affiliation': 'Department of Infectious Diseases and Tropical Medicine, Hôpital Européen Georges Pompidou, APHP, F-75000, Paris, France.'}, {'ForeName': 'Josselin', 'Initials': 'J', 'LastName': 'Lebel', 'Affiliation': 'Department of General Practice, Université de Paris, F-75018, Paris, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dupouy', 'Affiliation': 'MSPU Pins Justaret, F-31860, Pins Justaret, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Roussillon', 'Affiliation': 'Clinical Research and Innovation Department, Safety and vigilance, CHU Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gimbert', 'Affiliation': 'Clinical Research and Innovation Department, CHU Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wittkop', 'Affiliation': 'CHU Bordeaux, Pôle de Santé Publique, F-33000, Bordeaux, France.'}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Thiébaut', 'Affiliation': 'Univ. Bordeaux, Inserm, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Orne-Gliemann', 'Affiliation': 'Inserm U1219, Univ. Bordeaux, IRD, F-33000, Bordeaux, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Joseph', 'Affiliation': 'Department of General Practice, CIC 1401, Univ. Bordeaux, F-33000, Bordeaux, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Richert', 'Affiliation': 'Univ. Bordeaux, Inserm, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Anglaret', 'Affiliation': 'Inserm U1219, Univ. Bordeaux, IRD, F-33000, Bordeaux, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Malvy', 'Affiliation': 'CHU Bordeaux, Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, F-33000, Bordeaux, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04619-1']
3181,33052602,Electronic cigarettes for smoking cessation.,"BACKGROUND
Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol formed by heating an e-liquid. People who smoke report using ECs to stop or reduce smoking, but some organisations, advocacy groups and policymakers have discouraged this, citing lack of evidence of efficacy and safety. People who smoke, healthcare providers and regulators want to know if ECs can help people quit and if they are safe to use for this purpose. This review is an update of a review first published in 2014.
OBJECTIVES
To evaluate the effect and safety of using electronic cigarettes (ECs) to help people who smoke achieve long-term smoking abstinence.
SEARCH METHODS
We searched the Cochrane Tobacco Addiction Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO for relevant records to January 2020, together with reference-checking and contact with study authors.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and randomized cross-over trials in which people who smoke were randomized to an EC or control condition. We also included uncontrolled intervention studies in which all participants received an EC intervention. To be included, studies had to report abstinence from cigarettes at six months or longer and/or data on adverse events (AEs) or other markers of safety at one week or longer.
DATA COLLECTION AND ANALYSIS
We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking after at least six months follow-up, AEs, and serious adverse events (SAEs). Secondary outcomes included changes in carbon monoxide, blood pressure, heart rate, blood oxygen saturation, lung function, and levels of known carcinogens/toxicants. We used a fixed-effect Mantel-Haenszel model to calculate the risk ratio (RR) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data from these studies in meta-analyses.
MAIN RESULTS
We include 50 completed studies, representing 12,430 participants, of which 26 are RCTs. Thirty-five of the 50 included studies are new to this review update. Of the included studies, we rated four (all which contribute to our main comparisons) at low risk of bias overall, 37 at high risk overall (including the 24 non-randomized studies), and the remainder at unclear risk. There was moderate-certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine EC than in those randomized to nicotine replacement therapy (NRT) (risk ratio (RR) 1.69, 95% confidence interval (CI) 1.25 to 2.27; I 2 = 0%; 3 studies, 1498 participants). In absolute terms, this might translate to an additional four successful quitters per 100 (95% CI 2 to 8). There was low-certainty evidence (limited by very serious imprecision) of no difference in the rate of adverse events (AEs) (RR 0.98, 95% CI 0.80 to 1.19; I 2 = 0%; 2 studies, 485 participants). SAEs occurred rarely, with no evidence that their frequency differed between nicotine EC and NRT, but very serious imprecision led to low certainty in this finding (RR 1.37, 95% CI 0.77 to 2.41: I 2 = n/a; 2 studies, 727 participants). There was moderate-certainty evidence, again limited by imprecision, that quit rates were higher in people randomized to nicotine EC than to non-nicotine EC (RR 1.71, 95% CI 1.00 to 2.92; I 2 = 0%; 3 studies, 802 participants). In absolute terms, this might again lead to an additional four successful quitters per 100 (95% CI 0 to 12). These trials used EC with relatively low nicotine delivery. There was low-certainty evidence, limited by very serious imprecision, that there was no difference in the rate of AEs between these groups (RR 1.00, 95% CI 0.73 to 1.36; I 2 = 0%; 2 studies, 346 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 0.25, 95% CI 0.03 to 2.19; I 2 = n/a; 4 studies, 494 participants). Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.50, 95% CI 1.24 to 5.04; I 2 = 0%; 4 studies, 2312 participants). In absolute terms this represents an increase of six per 100 (95% CI 1 to 14). However, this finding was very low-certainty, due to issues with imprecision and risk of bias. There was no evidence that the rate of SAEs varied, but some evidence that non-serious AEs were more common in people randomized to nicotine EC (AEs: RR 1.17, 95% CI 1.04 to 1.31; I 2 = 28%; 3 studies, 516 participants; SAEs: RR 1.33, 95% CI 0.25 to 6.96; I 2 = 17%; 5 studies, 842 participants). Data from non-randomized studies were consistent with RCT data. The most commonly reported AEs were throat/mouth irritation, headache, cough, and nausea, which tended to dissipate over time with continued use. Very few studies reported data on other outcomes or comparisons and hence evidence for these is limited, with confidence intervals often encompassing clinically significant harm and benefit.
AUTHORS' CONCLUSIONS
There is moderate-certainty evidence that ECs with nicotine increase quit rates compared to ECs without nicotine and compared to NRT. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain. More studies are needed to confirm the degree of effect, particularly when using modern EC products. Confidence intervals were wide for data on AEs, SAEs and other safety markers. Overall incidence of SAEs was low across all study arms. We did not detect any clear evidence of harm from nicotine EC, but longest follow-up was two years and the overall number of studies was small. The main limitation of the evidence base remains imprecision due to the small number of RCTs, often with low event rates. Further RCTs are underway. To ensure the review continues to provide up-to-date information for decision-makers, this review is now a living systematic review. We will run searches monthly from December 2020, with the review updated as relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.",2020,"Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.50, 95% CI 1.24 to 5.04; I 2 = 0%; 4 studies, 2312 participants).","['people who smoke', '50 completed studies, representing 12,430 participants, of which 26 are RCTs', 'people who smoke achieve long-term smoking abstinence']","['nicotine EC', 'EC or control condition', 'Electronic cigarettes', 'EC intervention', 'electronic cigarettes (ECs', 'nicotine replacement therapy (NRT) (risk ratio (RR']","['quit rates', 'rates of SAEs', 'Overall incidence of SAEs', 'throat/mouth irritation, headache, cough, and nausea', 'rate of SAEs', 'rate of adverse events', 'abstinence from smoking after at least six months follow-up, AEs, and serious adverse events (SAEs', 'risk ratio (RR', 'rate of AEs', 'changes in carbon monoxide, blood pressure, heart rate, blood oxygen saturation, lung function, and levels of known carcinogens/toxicants']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0235339', 'cui_str': 'Mouth irritation'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0007090', 'cui_str': 'Carcinogen'}]",12430.0,0.543092,"Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.50, 95% CI 1.24 to 5.04; I 2 = 0%; 4 studies, 2312 participants).","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Hartmann-Boyce', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Hayden', 'Initials': 'H', 'LastName': 'McRobbie', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lindson', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Begh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Theodoulou', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Notley', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Tobacco Research and Treatment Center, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Tari', 'Initials': 'T', 'LastName': 'Turner', 'Affiliation': 'Cochrane Australia, School of Public Health & Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Ailsa R', 'Initials': 'AR', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hajek', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts & The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010216.pub4']
3182,33049909,Effect of Family-Based REDUCE Intervention Program on Children Eating Behavior and Dietary Intake: Randomized Controlled Field Trial.,"The objective of this study was to evaluate the effect of a family-based intervention program (REDUCE) on children's eating behaviors and dietary intake. A two-arm randomized controlled field trial was conducted among parents and children of 7 to 10 years old who were either overweight or obese. The intervention was conducted via face-to-face sessions and social media. The child eating behaviors were assessed using the child eating behaviors questionnaire (CEBQ), while their dietary consumption of vegetables and unhealthy snacks was assessed using a parental report of three days unweighted food. The generalized linear mixed modelling adjusted for covariates was used to estimate the intervention effects with alpha of 0.05. A total of 122 parents (91% response rate) completed this study. At the six-month post-training, there were statistically significant mean differences in the enjoyment of food (F(6481) = 4.653, p < 0.001), fruit and vegetable intake (F(6480) = 4.165, p < 0.001) and unhealthy snack intake (F(6480) = 5.062, p < 0.001) between the intervention and wait-list groups; however, it was not clinically meaningful. This study added to the body of knowledge of family-based intervention that utilized social media and assessed the effect in children's eating behavior using the CEBQ and children's dietary intake.",2020,"p < 0.001) and unhealthy snack intake (F(6480) = 5.062, p < 0.001) between the intervention and wait-list groups; however, it was not clinically meaningful.","[""children's eating behaviors and dietary intake"", '122 parents (91% response rate) completed this study', ""children's eating behavior using the CEBQ and children's dietary intake"", 'parents and children of 7 to 10 years old who were either overweight or obese', 'Children Eating Behavior and Dietary Intake']","['Family-Based REDUCE Intervention Program', 'family-based intervention program (REDUCE']","['child eating behaviors questionnaire (CEBQ), while their dietary consumption of vegetables and unhealthy snacks', 'child eating behaviors', 'unhealthy snack intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",122.0,0.0364819,"p < 0.001) and unhealthy snack intake (F(6480) = 5.062, p < 0.001) between the intervention and wait-list groups; however, it was not clinically meaningful.","[{'ForeName': 'Norliza', 'Initials': 'N', 'LastName': 'Ahmad', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Science, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Zalilah Mohd', 'Initials': 'ZM', 'LastName': 'Shariff', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Science, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Firdaus', 'Initials': 'F', 'LastName': 'Mukhtar', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Health Science, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Munn-Sann', 'Initials': 'MS', 'LastName': 'Lye', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Science, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}]",Nutrients,['10.3390/nu12103065']
3183,33050321,Brief Hospital Supervision of Exercise and Diet During Adjuvant Breast Cancer Therapy Is Not Enough to Relieve Fatigue: A Multicenter Randomized Controlled Trial.,"Supervised exercise dietary programs are recommended to relieve cancer-related fatigue and weight increase induced by adjuvant treatment of early breast cancer (EBC). As this recommendation lacks a high level of evidence, we designed a multicenter randomized trial to evaluate the impact of an Adapted Physical Activity Diet (APAD) education program on fatigue. We randomized 360 women with EBC who were receiving adjuvant chemotherapy and radiotherapy to APAD or usual care at eight French cancer institutions. Data were collected at baseline, end of chemotherapy, end of radiotherapy, and 6 months post-treatment. The primary endpoint was the general cancer-related fatigue score using the MFI-20 questionnaire. Fatigue correlated with the level of precariousness, but we found no significant difference between the two groups in terms of general fatigue ( p = 0.274). The APAD arm has a smaller proportion of patients with confirmed depression at the end of follow-up ( p = 0.052). A transient modification in physical activity levels and dietary intake was reported in the experimental arm. However, a mixed hospital- and home-based APAD education program is not enough to improve fatigue caused by adjuvant treatment of EBC. Cancer care centers should consider integrating more proactive diet-exercise supportive care in this population, focusing on precarious patients.",2020,"Fatigue correlated with the level of precariousness, but we found no significant difference between the two groups in terms of general fatigue ( p = 0.274).","['Cancer care centers', 'or usual care at eight French cancer institutions', '360 women with EBC who were receiving']","['Exercise and Diet', 'Supervised exercise dietary programs', 'Adapted Physical Activity Diet (APAD) education program', 'adjuvant chemotherapy and radiotherapy to APAD']","['general fatigue', 'fatigue', 'physical activity levels and dietary intake', 'general cancer-related fatigue score using the MFI-20 questionnaire', 'Fatigue']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",360.0,0.0467317,"Fatigue correlated with the level of precariousness, but we found no significant difference between the two groups in terms of general fatigue ( p = 0.274).","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Jacot', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Arnaud', 'Affiliation': 'Sainte-Catherine Institute, 1750 Chemin Lavarin, 84000 Avignon, France.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Jarlier', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lefeuvre-Plesse', 'Affiliation': 'Eugène Marquis Center, Rue de la Bataille Flandres-Dunkerque, CS 44229, 35042 Rennes, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Dalivoust', 'Affiliation': ""Ambroise Paré Hospital, 1 Rue de l'Eylau, 13006 Marseille, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Senesse', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Azzedine', 'Affiliation': 'Montélimar Hospital, Quartier Beausseret, BP 249-26, 26216 Montélimar, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Tredan', 'Affiliation': 'Léon Bérard Center, 28 Rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Sadot-Lebouvier', 'Affiliation': 'René Gauducheau Center, Boulevard Jacques Monod, 44805 Saint-Herblain, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Mas', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Carayol', 'Affiliation': 'IAPS Laboratory ""Impact of Physical Activity on Health"", University of Toulon, Avenue de l\'Université, 83957 La Garde, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Bleuse', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Gourgou', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Janiszewski', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Silene', 'Initials': 'S', 'LastName': 'Launay', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': ""D'Hondt"", 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Lauridant', 'Affiliation': 'Oscar Lambret Center, 3 Rue Frédéric Combemale, 59000 Lille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Grenier', 'Affiliation': 'Sainte-Catherine Institute, 1750 Chemin Lavarin, 84000 Avignon, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Romieu', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Ninot', 'Affiliation': ""Val d'Aurelle Montpellier Cancer Institute (ICM), 208 Avenue des Apothicaires, Parc Euromédecine, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Vanlemmens', 'Affiliation': 'Oscar Lambret Center, 3 Rue Frédéric Combemale, 59000 Lille, France.'}]",Nutrients,['10.3390/nu12103081']
3184,33050325,Non-Surgical Periodontal Therapy with Adjunctive Amoxicillin/Metronidazole or Metronidazole When No Aggregatibacter actinomycetemcomitans Is Detected-A Randomized Clinical Trial.,"BACKGROUND
The aim was to compare two different systemic antibiotics regimens adjunctive to non-surgical periodontal therapy when Aggregatibacter actinomycetemcomitans was not detected in the subgingival biofilm.
METHODS
A total of 58 patients with periodontitis and with no A. actinomycetemcomitans in the subgingival biofilm were treated with full-mouth subgingival instrumentation and either metronidazole (MET; n = 29) or amoxicillin/metronidazole (AMX/MET; n = 29). Probing depth (PD), clinical attachment level (CAL) and bleeding on probing (BOP) were recorded at baseline, as well as after three and six months. Subgingival biofilm and gingival crevicular fluid were collected and analyzed for major periodontopathogens and biomarkers.
RESULTS
PD, CAL and BOP improved at 3 and 6 months (each p < 0.001 vs. baseline) with no difference between the groups. Sites with initial PD ≥ 6 mm also improved in both groups after 3 and 6 months ( p < 0.001) with a higher reduction of PD in the AMX/MET group ( p < 0.05). T. forsythia was lower in the AMX/MET group after 3 months ( p < 0.05). MMP-8 and IL-1β were without significant changes and differences between the groups.
CONCLUSION
When A. actinomycetemcomitans was not detected in the subgingival biofilm, the adjunctive systemic use of amoxicillin/metronidazole results in better clinical and microbiological outcomes of non-surgical periodontal therapy when the application of systemic antibiotics is scheduled.",2020,T. forsythia was lower in the AMX/MET group after 3 months ( p < 0.05).,['58 patients with periodontitis and with no A. actinomycetemcomitans in the subgingival biofilm'],"['amoxicillin/metronidazole', 'Amoxicillin/Metronidazole or Metronidazole', 'amoxicillin/metronidazole (AMX/MET', 'metronidazole']","['MMP-8 and IL-1β', 'Probing depth (PD), clinical attachment level (CAL) and bleeding on probing (BOP', 'T. forsythia', 'PD, CAL and BOP', 'Subgingival biofilm and gingival crevicular fluid']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}]","[{'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C1018538', 'cui_str': 'Lian qiao'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}]",58.0,0.0764114,T. forsythia was lower in the AMX/MET group after 3 months ( p < 0.05).,"[{'ForeName': 'Holger F R', 'Initials': 'HFR', 'LastName': 'Jentsch', 'Affiliation': 'Centre for Periodontology, Department of Cariology, Endodontology and Periodontology, University Hospital of Leipzig, Liebigstr. 12, Haus 1, D-04103 Leipzig, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dietrich', 'Affiliation': 'Private Dental Practice, Borngasse 12, D-99084 Erfurt, Germany.'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Eick', 'Affiliation': 'Department of Periodontology, Laboratory of Oral Microbiology, School of Dental Medicine, University of Bern, Freiburgstr. 7, CH-3010 Bern, Switzerland.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9100686']
3185,33060615,Patient outcomes following GPs' educations about COPD: a cluster randomized controlled trial.,"This study aimed to compare patient outcomes following case method learning and traditional lectures as methods for continuing medical education (CME) about chronic obstructive pulmonary disease (COPD) for general practitioners (GPs) in Sweden. In a pragmatic cluster randomized controlled trial, COPD patients (n = 425; case method group n = 209, traditional lectures group n = 216) from 24 primary health care centers replied to questionnaires prior to and 18 months after a 2 × 2-h CME was given to GPs (n = 255). We measured changes in the scores of the Clinical COPD Questionnaire (CCQ), symptoms, needs for disease information, exacerbations, smoking, and use of pulmonary rehabilitation. The changes over time were similar for both CME methods. Patients who had used pulmonary rehabilitation increased from 13.2 to 17.8% (P = 0.04), and prevalence of smoking decreased from 28.9 to 25.1% (P = 0.003). In conclusion, neither of the used CME methods was superior than the other regarding patient outcomes. CME's primary value may lay in improving GPs' adherence to guidelines, which should lead to long-term positive changes in patient health.",2020,"Patients who had used pulmonary rehabilitation increased from 13.2 to 17.8% (P = 0.04), and prevalence of smoking decreased from 28.9 to 25.1% (P = 0.003).","['patients (n\u2009=\u2009425; case', 'continuing medical education (CME) about chronic obstructive pulmonary disease (COPD) for general practitioners (GPs) in Sweden']","[""GPs' educations about COPD"", 'method group n\u2009=\u2009209, traditional lectures group n\u2009=\u2009216) from 24 primary health care centers replied to questionnaires prior to and 18 months after a 2\u2009×\u20092-h CME was given to GPs', 'case method learning and traditional lectures', 'COPD']","['Clinical COPD Questionnaire (CCQ), symptoms, needs for disease information, exacerbations, smoking, and use of pulmonary rehabilitation', 'prevalence of smoking', 'pulmonary rehabilitation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0013632', 'cui_str': 'Continuing Medical Education'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C3266515', 'cui_str': 'Education about chronic obstructive pulmonary disease'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0013632', 'cui_str': 'Continuing Medical Education'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C2919593', 'cui_str': 'Clinical chronic obstructive pulmonary disease questionnaire'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",,0.169765,"Patients who had used pulmonary rehabilitation increased from 13.2 to 17.8% (P = 0.04), and prevalence of smoking decreased from 28.9 to 25.1% (P = 0.003).","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Sandelowsky', 'Affiliation': 'Karolinska Institutet, Department of Medicine, Division of Clinical Epidemiology, SE-171 76, Stockholm, Sweden. hanna.sandelowsky@ki.se.'}, {'ForeName': 'Ingvar', 'Initials': 'I', 'LastName': 'Krakau', 'Affiliation': 'Karolinska Institutet, Department of Medicine, Division of Clinical Epidemiology, SE-171 76, Stockholm, Sweden.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Modin', 'Affiliation': 'Karolinska Institutet, NVS, Section for Family Medicine and Primary Care, Alfred Nobels Allé 23, Huddinge, SE-141 83, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Ställberg', 'Affiliation': 'Uppsala University, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine, Box 564, SE-751 22, Uppsala, Sweden.'}, {'ForeName': 'Sven-Erik', 'Initials': 'SE', 'LastName': 'Johansson', 'Affiliation': 'Lund University, Center for Primary Health Care Research, Department of Clinical Sciences, SE-205 02, Malmö, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nager', 'Affiliation': 'Karolinska Institutet, NVS, Section for Family Medicine and Primary Care, Alfred Nobels Allé 23, Huddinge, SE-141 83, Stockholm, Sweden.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-020-00204-w']
3186,33060632,Identifying a nasal gene expression signature associated with hyperinflation and treatment response in severe COPD.,"Hyperinflation contributes to dyspnea intensity in COPD. Little is known about the molecular mechanisms underlying hyperinflation and how inhaled corticosteroids (ICS) affect this important aspect of COPD pathophysiology. To investigate the effect of ICS/long-acting β 2 -agonist (LABA) treatment on both lung function measures of hyperinflation, and the nasal epithelial gene-expression profile in severe COPD. 117 patients were screened and 60 COPD patients entered a 1-month run-in period on low-dose ICS/LABA budesonide/formoterol (BUD/F) 200/6 one inhalation b.i.d. Patients were then randomly assigned to 3-month treatment with either a high dose BDP/F 100/6 two inhalations b.i.d. (n = 31) or BUD/F 200/6 two inhalations b.i.d. (n = 29). Lung function measurements and nasal epithelial gene-expression were assessed before and after 3-month treatment and validated in independent datasets. After 3-month ICS/LABA treatment, residual volume (RV)/total lung capacity (TLC)% predicted was reduced compared to baseline (p < 0.05). We identified a nasal gene-expression signature at screening that associated with higher RV/TLC% predicted values. This signature, decreased by ICS/LABA treatment was enriched for genes associated with increased p53 mediated apoptosis was replicated in bronchial biopsies of COPD patients. Finally, this signature was increased in COPD patients compared to controls in nasal, bronchial and small airways brushings. Short-term ICS/LABA treatment improves RV/TLC% predicted in severe COPD. Furthermore, it decreases the expression of genes involved in the signal transduction by the p53 class mediator, which is a replicable COPD gene expression signature in the upper and lower airways.Trial registration: ClinicalTrials.gov registration number NCT01351792 (registration date May 11, 2011), ClinicalTrials.gov registration number NCT00848406 (registration date February 20, 2009), ClinicalTrials.gov registration number NCT00158847 (registration date September 12, 2005).",2020,"This signature, decreased by ICS/LABA treatment was enriched for genes associated with increased p53 mediated apoptosis was replicated in bronchial biopsies of COPD patients.","['117 patients were screened and 60 COPD patients entered a 1-month run-in period on low-dose ICS', 'severe COPD']","['LABA budesonide/formoterol (BUD/F', 'LABA', 'ICS/long-acting β 2 -agonist (LABA']","['Lung function measurements and nasal epithelial gene-expression', 'p53 mediated apoptosis', 'residual volume (RV)/total lung capacity (TLC)% predicted', 'RV/TLC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0086571', 'cui_str': 'Lung Capacities'}, {'cui': 'C0008569', 'cui_str': 'Thin Layer Chromatography'}]",117.0,0.157791,"This signature, decreased by ICS/LABA treatment was enriched for genes associated with increased p53 mediated apoptosis was replicated in bronchial biopsies of COPD patients.","[{'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Faiz', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Imkamp', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. k.imkamp@umcg.nl.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'van der Wiel', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Ilse M', 'Initials': 'IM', 'LastName': 'Boudewijn', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Gerard H', 'Initials': 'GH', 'LastName': 'Koppelman', 'Affiliation': 'GRIAC (Groningen Research Institute for Asthma and COPD), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Corry-Anke', 'Initials': 'CA', 'LastName': 'Brandsma', 'Affiliation': 'GRIAC (Groningen Research Institute for Asthma and COPD), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Timens', 'Affiliation': 'GRIAC (Groningen Research Institute for Asthma and COPD), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Vroegop', 'Affiliation': 'Department of Pulmonary Diseases, Martini Hospital Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Henk R', 'Initials': 'HR', 'LastName': 'Pasma', 'Affiliation': 'Department of Pulmonary Diseases, Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Wim G', 'Initials': 'WG', 'LastName': 'Boersma', 'Affiliation': 'Department of Pulmonary Diseases, Medical Center Alkmaar, Alkmaar, The Netherlands.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Wielders', 'Affiliation': 'Department of Pulmonary Diseases, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van den Elshout', 'Affiliation': 'Department of Pulmonary Diseases, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mansour', 'Affiliation': 'Department of Pulmonary Diseases, Orbis Concern, Sittard, The Netherlands.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Steiling', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Avrum', 'Initials': 'A', 'LastName': 'Spira', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Lenburg', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Irene H', 'Initials': 'IH', 'LastName': 'Heijink', 'Affiliation': 'GRIAC (Groningen Research Institute for Asthma and COPD), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Dirkje S', 'Initials': 'DS', 'LastName': 'Postma', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'van den Berge', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}]",Scientific reports,['10.1038/s41598-020-72551-0']
3187,33055072,Exploring the Effects of a Brief Biofeedback Breathing Session Delivered Through the BioBase App in Facilitating Employee Stress Recovery: Randomized Experimental Study.,"BACKGROUND
Recovery from stress is a predictive factor for cardiovascular health, and heart rate variability (HRV) is suggested to be an index of how well people physiologically recover from stress. Biofeedback and mindfulness interventions that include guided breathing have been shown to be effective in increasing HRV and facilitating stress recovery.
OBJECTIVE
This study aims to assess the effectiveness of a brief app-based breathing intervention (BioBase) in enhancing physiological recovery among employees who were induced to cognitive and emotional stress.
METHODS
In total, we recruited 75 full-time employees. Interbeat (RR) intervals were recorded continuously for 5 min at baseline and during cognitive and emotional stress induction. The session ended with a 5-min recovery period during which participants were randomly allocated into 3 conditions: app-based breathing (BioBase), mindfulness body scan, or control. Subjective tension was assessed at the end of each period.
RESULTS
Subjective tension significantly increased following stress induction. HRV significantly decreased following the stress period. In the recovery phase, the root mean square of successive RR interval differences (P=.002), the percentage of successive RR intervals that differed by >50 ms (P=.008), and high frequency (P=.01) were significantly higher in the BioBase breathing condition than in the mindfulness body scan and the control groups.
CONCLUSIONS
Biofeedback breathing interventions digitally delivered through a commercially available app can be effective in facilitating stress recovery among employees. These findings contribute to the mobile health literature on the beneficial effects of brief app-based breathing interventions on employees' cardiovascular health.",2020,"In the recovery phase, the root mean square of successive RR interval differences (P=.002), the percentage of successive RR intervals that differed by >50 ms (P=.008), and high frequency (P=.01) were significantly higher in the BioBase breathing condition than in the mindfulness body scan and the control groups.
","['Facilitating Employee Stress Recovery', 'employees who were induced to cognitive and emotional stress']","['3 conditions: app-based breathing (BioBase), mindfulness body scan, or control', 'Biofeedback and mindfulness interventions', 'brief app-based breathing intervention (BioBase', 'Brief Biofeedback Breathing Session']","['root mean square of successive RR interval differences', 'HRV', 'Subjective tension', 'percentage of successive RR intervals', 'Interbeat (RR) intervals']","[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0086209', 'cui_str': 'Emotional stress'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",75.0,0.0320185,"In the recovery phase, the root mean square of successive RR interval differences (P=.002), the percentage of successive RR intervals that differed by >50 ms (P=.008), and high frequency (P=.01) were significantly higher in the BioBase breathing condition than in the mindfulness body scan and the control groups.
","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Chelidoni', 'Affiliation': 'Evolution, Behaviour and Environment, School of Life Sciences, University of Sussex, Brighton, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Plans', 'Affiliation': 'Initiative in the Digital Economy, Department of Science, Innovation, Technology, and Entrepreneurship, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Ponzo', 'Affiliation': 'BioBeats Group Ltd, London, United Kingdom.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Morelli', 'Affiliation': 'BioBeats Group Ltd, London, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cropley', 'Affiliation': 'Faculty of Health and Medical Sciences, School of Psychology, University of Surrey, Guildford, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/19412']
3188,33026741,Interferon Beta-1b and Lopinavir-Ritonavir for Middle East Respiratory Syndrome.,"BACKGROUND
Whether combined treatment with recombinant interferon beta-1b and lopinavir-ritonavir reduces mortality among patients hospitalized with Middle East respiratory syndrome (MERS) is unclear.
METHODS
We conducted a randomized, adaptive, double-blind, placebo-controlled trial that enrolled patients at nine sites in Saudi Arabia. Hospitalized adults with laboratory-confirmed MERS were randomly assigned to receive recombinant interferon beta-1b plus lopinavir-ritonavir (intervention) or placebo for 14 days. The primary outcome was 90-day all-cause mortality, with a one-sided P-value threshold of 0.025. Prespecified subgroup analyses and safety analyses were conducted. Because of the pandemic of coronavirus disease 2019, the data and safety monitoring board requested an unplanned interim analysis and subsequently recommended the termination of enrollment and the reporting of the results.
RESULTS
A total of 95 patients were enrolled; 43 patients were assigned to the intervention group and 52 to the placebo group. A total of 12 patients (28%) in the intervention group and 23 (44%) in the placebo group died by day 90. The analysis of the primary outcome, with accounting for the adaptive design, yielded a risk difference of -19 percentage points (upper boundary of the 97.5% confidence interval [CI], -3; one-sided P = 0.024). In a prespecified subgroup analysis, treatment within 7 days after symptom onset led to lower 90-day mortality than use of placebo (relative risk, 0.19; 95% CI, 0.05 to 0.75), whereas later treatment did not. Serious adverse events occurred in 4 patients (9%) in the intervention group and in 10 (19%) in the placebo group.
CONCLUSIONS
A combination of recombinant interferon beta-1b and lopinavir-ritonavir led to lower mortality than placebo among patients who had been hospitalized with laboratory-confirmed MERS. The effect was greatest when treatment was started within 7 days after symptom onset. (Funded by the King Abdullah International Medical Research Center; MIRACLE ClinicalTrials.gov number, NCT02845843.).",2020,A combination of recombinant interferon beta-1b and lopinavir-ritonavir led to lower mortality than placebo among patients who had been hospitalized with laboratory-confirmed MERS.,"['A total of 95 patients were enrolled; 43 patients', 'Hospitalized adults with laboratory-confirmed MERS', 'enrolled patients at nine sites in Saudi Arabia', 'Middle East Respiratory Syndrome', 'patients hospitalized with Middle East respiratory syndrome (MERS', 'patients who had been hospitalized with laboratory-confirmed MERS']","['Interferon Beta-1b and Lopinavir-Ritonavir', 'placebo', 'recombinant interferon beta-1b and lopinavir-ritonavir', 'recombinant interferon beta-1b plus lopinavir-ritonavir (intervention) or placebo']","['90-day all-cause mortality', 'Serious adverse events', '90-day mortality']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C3694279', 'cui_str': 'Middle East respiratory syndrome'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}]","[{'cui': 'C0244713', 'cui_str': 'interferon beta-1b'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",95.0,0.768763,A combination of recombinant interferon beta-1b and lopinavir-ritonavir led to lower mortality than placebo among patients who had been hospitalized with laboratory-confirmed MERS.,"[{'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ayed Y', 'Initials': 'AY', 'LastName': 'Asiri', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Assiri', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hanan H', 'Initials': 'HH', 'LastName': 'Balkhy', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al Bshabshe', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Majed', 'Initials': 'M', 'LastName': 'Al Jeraisy', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Mandourah', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Mohamed H A', 'Initials': 'MHA', 'LastName': 'Azzam', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Abdulhadi M', 'Initials': 'AM', 'LastName': 'Bin Eshaq', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Al Johani', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shmeylan', 'Initials': 'S', 'LastName': 'Al Harbi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hani A A', 'Initials': 'HAA', 'LastName': 'Jokhdar', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Deeb', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Memish', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jesna', 'Initials': 'J', 'LastName': 'Jose', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sameeh', 'Initials': 'S', 'LastName': 'Ghazal', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Al Faraj', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ghaleb A', 'Initials': 'GA', 'LastName': 'Al Mekhlafi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Nisreen M', 'Initials': 'NM', 'LastName': 'Sherbeeni', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fatehi E', 'Initials': 'FE', 'LastName': 'Elzein', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Al-Hameed', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Al Saedi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Naif K', 'Initials': 'NK', 'LastName': 'Alharbi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'Al-Dawood', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelzaher', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Wail', 'Initials': 'W', 'LastName': 'Bajhmom', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Badriah M', 'Initials': 'BM', 'LastName': 'AlMutairi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Hussein', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Alothman', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2015294']
3189,33038500,A pharmacist intervention for monitoring and treating hypertension using bidirectional texting: PharmText BP.,"BACKGROUND
New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation. We have developed a custom-built bi-directional texting platform for home BP measurements that can then be managed by clinical pharmacists located remotely. The purpose of this study is to evaluate whether the BP texting approach combined with a pharmacist-based intervention improves BP management and to determine if the approach is cost effective.
METHODS
This study is a randomized, prospective trial in four primary care offices that serve patients in rural areas. Subjects will receive standardized research BP measurements at baseline, 6 and 12 months. The primary outcome will be differences between the intervention and control group in mean systolic BP at 12 months. Secondary outcomes will include systolic BP at 6 months; diastolic BP at 6 and 12 months, number of medication changes and costs.
CONCLUSIONS
This study plans to enroll subjects through 2022, follow-up will be completed in 2023 and results will be available in 2024. This study will provide information on whether a combined approach using texting of home BP values and a pharmacist-based telehealth services can improve BP control.",2020,"BACKGROUND
New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation.","['patients in rural areas or for those who lack transportation', 'four primary care offices that serve patients in rural areas']",['pharmacist-based intervention'],"['systolic BP at 6\u202fmonths; diastolic BP at 6 and 12\u202fmonths, number of medication changes and costs', 'blood pressure (BP', 'mean systolic BP', 'BP management']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442603', 'cui_str': 'Office'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}]",4.0,0.0842913,"BACKGROUND
New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation.","[{'ForeName': 'Linnea A', 'Initials': 'LA', 'LastName': 'Polgreen', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, USA. Electronic address: linnea-polgreen@uiowa.edu.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Carter', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, USA; Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Polgreen', 'Affiliation': 'Department of Internal Medicine, College of Medicine, University of Iowa, USA; Department of Epidemiology, College of Public Health, University of Iowa, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Snyder', 'Affiliation': 'Department of Internal Medicine, College of Medicine, University of Iowa, USA.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Sewell', 'Affiliation': 'Department of Biostatistics, College of Public Health, University of Iowa, USA.'}, {'ForeName': 'Emine O', 'Initials': 'EO', 'LastName': 'Bayman', 'Affiliation': 'Department of Biostatistics, College of Public Health, University of Iowa, USA; Department of Anesthesia, College of Medicine, University of Iowa, USA.'}, {'ForeName': 'Shelby L', 'Initials': 'SL', 'LastName': 'Francis', 'Affiliation': 'Department of Internal Medicine, College of Medicine, University of Iowa, USA.'}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Simmering', 'Affiliation': 'Department of Internal Medicine, College of Medicine, University of Iowa, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Finkelstein', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106169']
3190,33043475,Digital technology for anaphylaxis management impact on patient behaviour: A randomized clinical trial.,"BACKGROUND
Epinephrine is the first-line treatment for anaphylaxis. Patients at risk should always carry an epinephrine autoinjector (EAI). Several EAI gaps have been identified. We sought to evaluate satisfaction using a medical device (digital technology comprising an EAI smart case connected to a mobile APP) with functions that overcome most of the EAI limitations and to determine whether patient behaviour and anaphylaxis management improve with its use.
METHODS
This was a randomized, open-label, crossover clinical trial in a tertiary hospital involving patients with history of anaphylaxis carrying an EAI. The study was conducted in two three-month periods, one with and one without the medical device. The primary endpoint was satisfaction with the medical device. Usability, adherence, anxiety and anaphylaxis episodes were evaluated as secondary endpoints.
RESULTS
A total of 100 patients were included (mean age 38.1 years, 74% female), and 95 completed the trial. The satisfaction visual analogue scale (VAS) after using the medical device was higher than before its use (89.1 [95% CI, 60.2-99.1] vs 56.3 [95% CI, 48.1-81.4]; P < .0001). The adherence VAS improved from 59.7 (95% CI, 54.0-65.3) to 88.6 (95% CI, 84.2-92.9) (P < .0001). Overall, 90% patients found the medical device easy to use. Patients' anxiety decreased from 52.2% to 29.3% (P < .001). Seven episodes of anaphylaxis occurred during the study, all in patients without the medical device (P = .025). Eighty-eight per cent of patients felt more involved in the management of anaphylaxis when using the medical device.
CONCLUSION
This is the first clinical trial evaluating digital technology for EAIs, showing a change of behaviour in patients at risk of anaphylaxis, increasing satisfaction, improving adherence, and reducing anxiety, with good usability.",2020,"Seven episodes of anaphylaxis occurred during the study, all in patients without the medical device (p=0.025).","['patients with history of anaphylaxis carrying an EAI', 'patient behaviour', 'A total of 100 patients were included (mean age 38.1 years, 74% female) and 95 completed the trial']","['epinephrine auto-injector (EAI', 'Epinephrine']","['satisfaction with the medical device', ""Patients' anxiety"", 'satisfaction Visual Analogue Scale (VAS', 'anaphylaxis', 'adherence VAS', 'Usability, adherence, anxiety and anaphylaxis episodes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C4047001', 'cui_str': 'Epinephrine Auto-Injector [Epipen]'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4047001', 'cui_str': 'Epinephrine Auto-Injector [Epipen]'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",100.0,0.119462,"Seven episodes of anaphylaxis occurred during the study, all in patients without the medical device (p=0.025).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sala-Cunill', 'Affiliation': ""Allergy Section, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Luengo', 'Affiliation': ""Allergy Section, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Curran', 'Affiliation': ""Vall d'Hebron Research Institute, Barcelona, Spain.""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Moreno', 'Affiliation': ""Allergy Section, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Moises', 'Initials': 'M', 'LastName': 'Labrador-Horrillo', 'Affiliation': ""Allergy Section, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Guilarte', 'Affiliation': ""Allergy Section, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Gonzalez-Medina', 'Affiliation': ""Allergy Section, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Galvan-Blasco', 'Affiliation': ""Allergy Section, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cardona', 'Affiliation': ""Allergy Section, Vall d'Hebron University Hospital, Barcelona, Spain.""}]",Allergy,['10.1111/all.14626']
3191,33065163,Metabolic impact of weight loss induced reduction of adipose ACE-2 - Potential implication in COVID-19 infections?,"BACKGROUND & AIMS
Angiotensin converting enzyme (ACE)-2 is a modulator of adipose tissue metabolism. However, human data of adipose ACE-2 is rarely available. Considering that, ACE-2 is believed to be the receptor responsible for cell entry of SARS-CoV-2, a better understanding of its regulation is desirable. We therefore characterized the modulation of subcutaneous adipose ACE-2 mRNA expression during weight loss and the impact of ACE-2 expression on weight loss induced short- and long-term improvements of glucose metabolism.
METHODS
143 subjects (age > 18; BMI ≥ 27 kg/m 2 ) were analyzed before and after a standardized 12-week dietary weight reduction program. Afterwards subjects were randomized to a 12-month lifestyle intervention or a control group (Maintain-Adults trial). Insulin sensitivity (IS) was estimated by HOMA-IR (as an estimate of liver IS) and ISI Clamp (as an estimate of skeletal muscle IS). ACE-2 mRNA expression (ACE-2 AT ) was measured in subcutaneous adipose tissue before and after weight loss.
RESULTS
ACE-2 AT was not affected by obesity, but was reduced in insulin resistant subjects. Weight loss resulted in a decline of ACE-2 AT (29.0 (20.0-47.9) vs. 21.0 (13.0-31.0); p = 1.6 ∗ 10 -7 ). A smaller reduction of ACE-2 AT (ΔACE-2 AT ) was associated with a larger improvement of ISI Clamp (p = 0.013) during weight reduction over 3 months, but not with the extend of weight loss. The degree of changes in insulin resistance were preserved until month 12 and was also predicted by the weight loss induced degree of ΔACE-2 AT (p = 0.011).
CONCLUSIONS
Our data indicate that subcutaneous adipose ACE-2 expression correlates with insulin sensitivity. Weight loss induced decline of subcutaneous adipose ACE-2 expression might affect short- and long-term improvement of myocellular insulin sensitivity, which might be also relevant in the context of ACE-2 downregulation by SARS-CoV-2.
TRIAL REGISTRATION
ClinicalTrials.gov number: NCT00850629, https://clinicaltrials.gov/ct2/show/NCT00850629, date of registration: February 25, 2009.",2020,"A smaller reduction of ACE-2 AT (ΔACE-2 AT ) was associated with a larger improvement of ISI Clamp (p = 0.013) during weight reduction over 3 months, but not with the extend of weight loss.",['143 subjects (age\u202f>\u202f18; BMI\u202f≥\u202f27\u202fkg/m 2 '],"['lifestyle intervention', 'ACE-2']","['Insulin sensitivity (IS', 'ACE-2 AT (ΔACE-2 AT ', 'degree of changes in insulin resistance', 'Weight loss', 'ISI Clamp', 'ACE-2 mRNA expression (ACE-2 AT ']","[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",143.0,0.0156104,"A smaller reduction of ACE-2 AT (ΔACE-2 AT ) was associated with a larger improvement of ISI Clamp (p = 0.013) during weight reduction over 3 months, but not with the extend of weight loss.","[{'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Clinical Research Unit, 10117 Berlin, Germany.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Spranger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Soll', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany.'}, {'ForeName': 'Finja', 'Initials': 'F', 'LastName': 'Beer', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Brachs', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charité Center for Cardiovascular Research, 10117 Berlin, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Spranger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charité Center for Cardiovascular Research, 10117 Berlin, Germany; DZHK (German Centre for Cardiovascular Research), Berlin, Germany. Electronic address: joachim.spranger@charite.de.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charité Center for Cardiovascular Research, 10117 Berlin, Germany; DZHK (German Centre for Cardiovascular Research), Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Clinical Research Unit, 10117 Berlin, Germany.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154401']
3192,33065191,A randomized controlled trial testing the effects of a positive front-of-pack label with or without a physical activity equivalent label on food purchases.,"BACKGROUND
Positive front-of-pack (FOP) labels, including Singapore's Healthier Choice Symbol (HCS), target a subset of healthier products whose consumption is to be encouraged. However, this may inadvertently lead to excess caloric intake, which could be addressed by including an additional label identifying calories per serving. We test this hypothesis by adding a Physical Activity Equivalent (PAE) label, an indicator of calorie content, to all products available in an on-line grocery store.
METHODS
We conducted a randomized controlled trial using a 3 arm within-subject crossover design in adult Singapore residents recruited online. Participants shopped once in each condition in an experimental online grocery store in random order: 1) no FOP label (Control); 2) Select products displaying HCS labels (HCS-only); 3) Condition 2 with additional information displaying PAEs per serving on every product (HCS+PAE). 117 participants were recruited and data from 317 shops were analyzed. We used first-differenced regressions to assess the impact of the conditions on calories per serving (primary) and on other measures of diet quality.
RESULTS
The HCS-only condition led to a statistically significant five-percentage point increase in the proportion of HCS products purchased (95% CI, 1%: 9%). However, neither the HCS-only (3.45; 95% CI, -12.52: 19.43) nor HCS + PAE (8.14; 95% CI, -5.25: 21.54) condition led to a change in the number of calories per serving purchased or changes in other measures of diet quality.
CONCLUSIONS
Positive labels, like the HCS, are likely to increase purchases of labelled products. However, these changes may not lead to improvements in diet quality or calorie intake. Combining positive labels with additional PAE information does not appear to address this concern.",2020,"The HCS-only condition led to a statistically significant five-percentage point increase in the proportion of HCS products purchased (95% CI, 1%: 9%).","['117 participants were recruited and data from 107 shops were analyzed', 'adult Singapore residents who were recruited online']","['Physical Activity Equivalent (PAE) label', 'Positive Front-of-Pack Label', 'FOP label (Control', '2) Select products displaying HCS labels (HCS-only); 3) Condition 2 with additional information displaying PAEs per serving on every product (HCS+PAE', ""positive FOP label, Singapore's Healthier Choice Symbol (HCSs""]",['diet quality or calorie intake'],"[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0041472', 'cui_str': 'Murine typhus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032052', 'cui_str': 'Human placental lactogen'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0010996', 'cui_str': 'Information Display'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",117.0,0.203633,"The HCS-only condition led to a statistically significant five-percentage point increase in the proportion of HCS products purchased (95% CI, 1%: 9%).","[{'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore; Saw Swee Hock School of Public Health, National University of Singapore, Singapore. Electronic address: eric.finkelstein@duke-nus.edu.sg.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Doble', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Felicia Jia Ler', 'Initials': 'FJL', 'LastName': 'Ang', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Wei Han Melvin', 'Initials': 'WHM', 'LastName': 'Wong', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Rob M', 'Initials': 'RM', 'LastName': 'van Dam', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}]",Appetite,['10.1016/j.appet.2020.104997']
3193,33040678,Mental Imagery as a Rehabilitative Therapy for Neuropathic Pain in People With Spinal Cord Injury: A Randomized Controlled Trial.,"BACKGROUND
Pain of neuropathic origin in spinal cord injury (SCI) is unbearable and challenging to treat. Research studies conducted in the past have shown that mental imagery (MI) techniques have a significant impact on the reduction of symptoms of central neuropathic pain in people with SCI.
OBJECTIVES
The objective of this study was to evaluate the effect of MI training on pain intensity, neuropathic pain symptoms, and interference of pain with function in SCI.
METHODS
A total of 42 SCI participants with central neuropathic pain (duration 6-12 months) were recruited and randomly allocated to MI or control groups. A MI training protocol was administered to MI group and for 30 min/d for 5 days. Outcome measures were assessed at baseline and at the end of 4 weeks.
RESULTS
There was significant reduction in differences of mean [95% CI] scores of numeric rating scale (-2.1 [CI -2.78 to -1.41]; P < .001) between groups. Mean [95% CI] total scores of Neuropathic Pain Symptom Inventory declined in MI group as compared with control group (-4.52 [CI -5.86 to -3.18]; P < .001). Similarly, Brief Pain Inventory interference scale total dropped significantly ( P < .001) in MI group. Majority of participants in the MI group (55%) reported improvement in scores of Patients' Global Impression of Change scale as compared with control group where most of the participants (52%) reported no change.
CONCLUSIONS
This study shows the effectiveness of the MI protocol developed as a rehabilitative approach in improving central neuropathic pain in SCI. Trial Registration . Clinical Trials Registry-India under Indian Council of Medical Research; CTRI/2018/07/014884. Registered July 16, 2018.",2020,"Similarly, Brief Pain Inventory interference scale total dropped significantly ( P < .001) in MI group.","['People With Spinal Cord Injury', 'A total of 42 SCI participants with central neuropathic pain (duration 6-12 months', 'spinal cord injury (SCI', 'people with SCI']","['MI training', 'MI protocol', 'Mental Imagery as a Rehabilitative Therapy']","['central neuropathic pain', 'Neuropathic Pain Symptom Inventory', 'pain intensity, neuropathic pain symptoms, and interference of pain with function', ""scores of Patients' Global Impression of Change scale"", 'Brief Pain Inventory interference scale total', 'numeric rating scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4087506', 'cui_str': 'Central neuropathic pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4087506', 'cui_str': 'Central neuropathic pain'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",42.0,0.34303,"Similarly, Brief Pain Inventory interference scale total dropped significantly ( P < .001) in MI group.","[{'ForeName': 'Jaskirat', 'Initials': 'J', 'LastName': 'Kaur', 'Affiliation': 'Amity University, Noida, Uttar Pradesh, India.'}, {'ForeName': 'Shampa', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Indian Council of Medical Research-National Institute of Nutrition, Hyderabad, Telangana, India.'}, {'ForeName': 'Asish Kumar', 'Initials': 'AK', 'LastName': 'Sahani', 'Affiliation': 'Indian Spinal Injuries Centre, New Delhi, India.'}, {'ForeName': 'Jitendra Kumar', 'Initials': 'JK', 'LastName': 'Sinha', 'Affiliation': 'Amity University, Noida, Uttar Pradesh, India.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320962498']
3194,33044838,A Biomechanical Comparison of 2 Hip Capsular Reconstruction Techniques: Iliotibial Band Autograft Versus Achilles Tendon Allograft.,"BACKGROUND
Several techniques for hip capsular reconstruction have been described to address gross instability or microinstability due to capsular deficiency. However, objective biomechanical data to support their use are lacking.
PURPOSE
To compare the kinematic effect of 2 capsular reconstruction techniques (iliotibial band [ITB] graft and Achilles tendon graft). Kinematic effect encompassed rotational range of motion (ROM) as well as joint translation in the coronal, sagittal, and axial planes.
STUDY DESIGN
Controlled laboratory study.
METHODS
8 paired, fresh-frozen hemi-pelvises (16 hips) were tested on a custom-designed joint motion simulator in the intact state and after capsulectomy. Pairs were randomly allocated to either ITB or Achilles reconstruction and retested. Testing was performed at 0°, 45°, and 90° of flexion. Internal-external rotation (IR-ER) torques and abduction-adduction torques of 3 N·m were applied to the femur via a load cell at each position, and rotational ROM and joint translation in the coronal, sagittal, and axial planes were recorded.
RESULTS
At 45° and 90°, there was a significant effect of the condition of the hip on the total IR-ER ( P = .004, effect size [ES] = 0.305; and P < .001, ES = 0.497; respectively). At 45°, mean ± SD total rotation was significantly greater for the capsulectomy (59.7°± 15.9°) state compared with intact (53.3°± 13.2°; P = .007). At 90°, reconstruction significantly decreased total rotation to 49.0°± 18.9° compared with a mean total rotation of 52.8°± 18.7° after capsulectomy ( P = .02). No difference was seen in the total abduction-adduction of the hip between conditions. Comparisons of the 2 different reconstruction techniques showed no significant differences in total IR-ER or abduction-adduction ROM or joint translation in the coronal, sagittal, or axial planes. For translation, at both 0° and 45° there was a statistically significant effect of the condition on the medial-lateral translation ( P = .033; ES = 0.204). Reconstruction, independent of technique, was successful in significantly decreasing ( P = .030; P = .014) the mean medial-lateral translation at 0° and 45° of hip flexion from 5.2 ± 3.8 mm and 5.6 ± 4.0 mm to 2.8 ± 1.9 mm and 3.9 ± 3.2 mm, respectively.
CONCLUSION
The integrity of the native hip capsule played a significant role in rotational stability, where capsulectomy significantly increased rotational ROM. Both ITB and Achilles reconstruction techniques restored normal rotational ROM of the hip at 90° of flexion as well as coronal plane stability at 0° and 45° of hip flexion. No differences were seen between ITB and Achilles reconstruction techniques.
CLINICAL RELEVANCE
Both capsular reconstruction techniques provide comparable joint kinematics, restoring rotation and translation to normal values with the exception of rotational ROM at 45°, which remained significantly greater than the intact state. The most significant results were the rotational stability at 90° of hip flexion and coronal plane stability at 0° and 45° of hip flexion, which were significantly improved compared with the capsulectomy state.",2020,"Comparisons of the 2 different reconstruction techniques showed no significant differences in total IR-ER or abduction-adduction ROM or joint translation in the coronal, sagittal, or axial planes.","['8 paired, fresh-frozen hemi-pelvises (16 hips', '2 Hip Capsular Reconstruction Techniques']","['2 capsular reconstruction techniques (iliotibial band [ITB] graft and Achilles tendon graft', 'ITB or Achilles reconstruction', 'Iliotibial Band Autograft Versus Achilles Tendon Allograft', 'custom-designed joint motion simulator']","['Internal-external rotation (IR-ER) torques and abduction-adduction torques', 'total IR-ER or abduction-adduction ROM or joint translation in the coronal, sagittal, or axial planes', 'rotational range of motion (ROM', 'total rotation', 'normal rotational ROM', 'medial-lateral translation', 'mean ± SD total rotation', 'rotational stability at 90° of hip flexion and coronal plane stability', 'total abduction-adduction', 'coronal plane stability', 'joint kinematics, restoring rotation and translation to normal values', 'rotational ROM', 'mean medial-lateral translation', 'condition of the hip on the total IR-ER', 'rotational stability']","[{'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0225266', 'cui_str': 'Structure of iliotibial tract'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0301196,"Comparisons of the 2 different reconstruction techniques showed no significant differences in total IR-ER or abduction-adduction ROM or joint translation in the coronal, sagittal, or axial planes.","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Pasic', 'Affiliation': 'Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Burkhart', 'Affiliation': 'Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Pardis', 'Initials': 'P', 'LastName': 'Baha', 'Affiliation': 'School of Kinesiology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Olufemi R', 'Initials': 'OR', 'LastName': 'Ayeni', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University Medical Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Getgood', 'Affiliation': 'Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Degen', 'Affiliation': 'Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}]",The American journal of sports medicine,['10.1177/0363546520962071']
3195,33046009,Feasibility of a yoga intervention to decrease pain in older women: a randomized controlled pilot study.,"BACKGROUND
A significant proportion of older women suffer from chronic pain, which can decrease quality of life. The objective of this pilot randomized study was to evaluate the feasibility of a flow-restorative yoga intervention designed to decrease pain and related outcomes among women aged 60 or older.
METHODS
Flow-restorative yoga classes were held twice weekly for 1 hour and led by a certified yoga instructor. Participants randomized to the intervention group attended the yoga classes for 12 weeks and received supplemental materials for at-home practice. Those randomized to the control group were asked to maintain their normal daily routine. Feasibility was evaluated using recruitment and retention rates, class and home practice adherence rates, and participant satisfaction surveys. Outcome measures (self-reported pain, inflammatory markers, functional fitness, quality of life, resilience, and self-reported physical activity) were assessed at baseline and post-intervention. Paired t-tests or Wilcoxon signed-rank tests were used to examine changes in outcome measures within treatment groups.
RESULTS
Thirty-eight participants were recruited and randomized. Participants were primarily white, college-educated, and higher functioning, despite experiencing various forms of chronic pain. Attendance and retention rates were high (91 and 97%, respectively) and the majority of participants were satisfied with the yoga program (89%) and would recommend it to others (87%). Intervention participants also experienced reductions in pain interference and improvements in energy and social functioning.
CONCLUSIONS
This pilot study provides essential data to inform a full scale randomized trial of flow-restorative yoga for older women with chronic pain. Future studies should emphasize strategies to recruit a more diverse study population, particularly older women at higher risk of disability and functional decline.
TRIAL REGISTRATION
Clinicaltrials.gov , NCT03790098 . Registered 31 December 2018 - Retrospectively registered.",2020,"Attendance and retention rates were high (91 and 97%, respectively) and the majority of participants were satisfied with the yoga program (89%) and would recommend it to others (87%).","['older women suffer from chronic pain', 'older women', 'women aged 60 or older', 'Participants were primarily white, college-educated, and higher functioning, despite experiencing various forms of chronic pain', 'Thirty-eight participants were recruited and randomized', 'older women with chronic pain', 'Registered 31 December 2018 - Retrospectively registered']","['flow-restorative yoga intervention', 'flow-restorative yoga', 'yoga intervention']","['pain interference and improvements in energy and social functioning', 'recruitment and retention rates, class and home practice adherence rates, and participant satisfaction surveys', 'Outcome measures (self-reported pain, inflammatory markers, functional fitness, quality of life, resilience, and self-reported physical activity', 'Attendance and retention rates', 'pain']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",38.0,0.162826,"Attendance and retention rates were high (91 and 97%, respectively) and the majority of participants were satisfied with the yoga program (89%) and would recommend it to others (87%).","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Seguin-Fowler', 'Affiliation': 'Texas A&M AgriLife Research, 600 John Kimborough Boulevard, Suite 512, College Station, TX, USA. r.seguin-fowler@ag.tamu.edu.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': 'Texas A&M University System, 600 John Kimborough Boulevard, Suite 512, College Station, TX, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Ward', 'Affiliation': 'Cornell University, 413 Savage Hall, Ithaca, NY, 14853, USA.'}, {'ForeName': 'Galen', 'Initials': 'G', 'LastName': 'Eldridge', 'Affiliation': 'Texas A&M AgriLife Research, 600 John Kimborough Boulevard, Suite 512, College Station, TX, USA.'}, {'ForeName': 'Urshila', 'Initials': 'U', 'LastName': 'Sriram', 'Affiliation': 'Texas A&M AgriLife Research, 600 John Kimborough Boulevard, Suite 512, College Station, TX, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Fine', 'Affiliation': 'Fine Spirit Yoga, 104 E. Lewis St, Ithaca, NY, 14850, USA.'}]",BMC geriatrics,['10.1186/s12877-020-01818-y']
3196,33047455,Comparison of viral control between two tenofovir dose reduction regimens (300 mg every 48 hours versus 300 mg every 72 hours) in chronic hepatitis B patients with moderate renal impairment from tenofovir-induced renal dysfunction.,"Long-term use of tenofovir disoproxil fumarate (TDF) can induce renal dysfunction that requires TDF dose reduction. Previous studies showed that systemic drug use exerts a threefold higher risk of moderate renal impairment. This study aimed to compare viral control between two tenofovir dose reduction regimens in chronic hepatitis B (CHB) patients with moderate renal impairment from TDF-induced renal dysfunction. This noninferiority, randomized controlled study was conducted at the Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. Virologically suppressed CHB patients treated with TDF who had moderate renal impairment were randomly allocated to receive TDF 300 mg either every 48 or 72 hours. Forty-six patients (67.4% male) with a mean age of 62.8 ± 7.8 years were enrolled. Among all patients, 34.8% were HBeAg-positive, and 23.9% had cirrhosis. All included patients completed 12 months of follow-up. No patients had virological breakthrough. After dose reduction, estimated glomerular filtration rate (eGFR) was improved in both groups, but a higher proportion of patients had an eGFR > 60 mL/min/1.73 m 2 in the TDF every 72 hours group. Other renal parameters, including serum phosphate, tubular maximal reabsorption for phosphate per GFR, urine protein-to-creatinine ratio, urine sugar and urine neutrophil gelatinase-associated lipocalin, were not significantly different between groups. Among TDF-treated CHB patients with TDF-induced moderate renal impairment, more aggressive dose reduction in TDF from every 48 hours to every 72 hours did not affect virological breakthrough. A higher proportion of patients in the TDF every 72 hours group had improvement in renal function.",2020,"After dose reduction, estimated glomerular filtration rate (eGFR) was improved in both groups, but a higher proportion of patients had an eGFR >","['Virologically-suppressed CHB patients treated with TDF who had moderate renal impairment', 'Forty-six patients (67.4% male) with a mean age of 62.8±7.8 years were enrolled', 'chronic hepatitis B patients with moderate renal impairment from tenofovir-induced renal dysfunction', 'Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand', 'chronic hepatitis B (CHB) patients with moderate renal impairment from TDF-induced renal dysfunction']","['tenofovir disoproxil fumarate (TDF', 'TDF', 'tenofovir']","['renal function', 'virological breakthrough', 'moderate renal impairment', 'serum phosphate, tubular maximal reabsorption for phosphate per GFR, urine protein to creatinine ratio, urine sugar, and urine neutrophil gelatinase-associated lipocalin', 'glomerular filtration rate (eGFR']","[{'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0262923', 'cui_str': 'Urine protein test'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017979', 'cui_str': 'Glycosuria'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",,0.02354,"After dose reduction, estimated glomerular filtration rate (eGFR) was improved in both groups, but a higher proportion of patients had an eGFR >","[{'ForeName': 'Watcharasak', 'Initials': 'W', 'LastName': 'Chotiyaputta', 'Affiliation': 'Faculty of Medicine Siriraj Hospital, Division of Gastroenterology, Department of Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Karn', 'Initials': 'K', 'LastName': 'Poosanasuwansri', 'Affiliation': 'Faculty of Medicine Siriraj Hospital, Division of Gastroenterology, Department of Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kraiwiporn', 'Initials': 'K', 'LastName': 'Kiattisunthorn', 'Affiliation': 'Faculty of Medicine Siriraj Hospital, Division of Nephrology, Department of Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Siwaporn', 'Initials': 'S', 'LastName': 'Chainuvati', 'Affiliation': 'Faculty of Medicine Siriraj Hospital, Division of Gastroenterology, Department of Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tawesak', 'Initials': 'T', 'LastName': 'Tanwandee', 'Affiliation': 'Faculty of Medicine Siriraj Hospital, Division of Gastroenterology, Department of Medicine, Mahidol University, Bangkok, Thailand.'}]",Journal of viral hepatitis,['10.1111/jvh.13420']
3197,33051212,Targeting rehabilitation to improve outcomes after total knee arthroplasty in patients at risk of poor outcomes: randomised controlled trial.,"OBJECTIVE
To evaluate whether a progressive course of outpatient physiotherapy offers superior outcomes to a single physiotherapy review and home exercise based intervention when targeted at patients with a predicted poor outcome after total knee arthroplasty.
DESIGN
Parallel group randomised controlled trial.
SETTING
13 secondary and tertiary care centres in the UK providing postoperative physiotherapy.
PARTICIPANTS
334 participants with knee osteoarthritis who were defined as at risk of a poor outcome after total knee arthroplasty, based on the Oxford knee score, at six weeks postoperatively. 163 were allocated to therapist led outpatient rehabilitation and 171 to a home exercise based protocol.
INTERVENTIONS
All participants were reviewed by a physiotherapist and commenced 18 sessions of rehabilitation over six weeks, either as therapist led outpatient rehabilitation (progressive goal oriented functional rehabilitation protocol, modified weekly in one-one contact sessions) or as physiotherapy review followed by a home exercise based regimen (without progressive input from a physiotherapist).
MAIN OUTCOME MEASURES
Primary outcome was Oxford knee score at 52 weeks, with a 4 point difference between groups considered to be clinically meaningful. Secondary outcomes included additional patient reported outcome measures of pain and function at 14, 26, and 52 weeks post-surgery.
RESULTS
334 patients were randomised. Eight were lost to follow-up. Intervention compliance was more than 85%. The between group difference in Oxford knee score at 52 weeks was 1.91 (95% confidence interval -0.18 to 3.99) points, favouring the outpatient rehabilitation arm (P=0.07). When all time point data were analysed, the between group difference in Oxford knee score was a non-clinically meaningful 2.25 points (0.61 to 3.90, P=0.01). No between group differences were found for secondary outcomes of average pain (0.25 points, -0.78 to 0.28, P=0.36) or worst pain (0.22 points, -0.71 to 0.41, P=0.50) at 52 weeks or earlier time points, or of satisfaction with outcome (odds ratio 1.07, 95% confidence interval 0.71 to 1.62, P=0.75) or post-intervention function (4.64 seconds, 95% confidence interval -14.25 to 4.96, P=0.34).
CONCLUSIONS
Outpatient therapist led rehabilitation was not superior to a single physiotherapist review and home exercise based regimen in patients at risk of poor outcomes after total knee arthroplasty. No clinically relevant differences were observed across primary or secondary outcome measures.
TRIALS REGISTRATION
Current Controlled Trials ISRCTN23357609 and ClinicalTrials.gov NCT01849445.",2020,The between group difference in Oxford knee score at 52 weeks was 1.91,"['patients at risk of poor outcomes after total knee arthroplasty', '334 participants with knee osteoarthritis who were defined as at risk of a poor outcome after total knee arthroplasty, based on the Oxford knee score, at six weeks postoperatively', '13 secondary and tertiary care centres in the UK providing postoperative physiotherapy', '334 patients were randomised', 'patients with a predicted poor outcome after total knee arthroplasty', 'patients at risk of poor outcomes']","['therapist led outpatient rehabilitation and 171 to a home exercise based protocol', 'therapist led outpatient rehabilitation (progressive goal oriented functional rehabilitation protocol, modified weekly in one-one contact sessions) or as physiotherapy review followed by a home exercise based regimen (without progressive input from a physiotherapist']","['Oxford knee score', 'worst pain', 'Intervention compliance', 'pain and function', 'average pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0454532', 'cui_str': 'Functional rehabilitation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",334.0,0.151286,The between group difference in Oxford knee score at 52 weeks was 1.91,"[{'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Hamilton', 'Affiliation': 'Department of Orthopaedics and Trauma, University of Edinburgh, Edinburgh EH16 4SB, UK d.f.hamilton@ed.ac.uk.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Beard', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Barker', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Macfarlane', 'Affiliation': 'Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology) Group, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Tuck', 'Affiliation': 'Usher Institute of Population Health, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Stoddart', 'Affiliation': 'Usher Institute of Population Health, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Wilton', 'Affiliation': 'Department of Orthopaedics, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Hutchinson', 'Affiliation': 'Department of Orthopaedic Surgery, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Gordon D', 'Initials': 'GD', 'LastName': 'Murray', 'Affiliation': 'Usher Institute of Population Health, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'A Hamish R W', 'Initials': 'AHRW', 'LastName': 'Simpson', 'Affiliation': 'Department of Orthopaedics and Trauma, University of Edinburgh, Edinburgh EH16 4SB, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.m3576']
3198,33051487,Prostate cancer risk prediction using a polygenic risk score.,"Hereditary factors have a strong influence on prostate cancer (PC) risk and poorer outcomes, thus stratification by genetic factors addresses a critical need for targeted PC screening and risk-adapted follow-up. In this Finnish population-based retrospective study 2283 clinically diagnosed and 455 screen-detected patients from the Finnish Randomised Study of Screening for Prostate Cancer (FinRSPC), 2400 healthy individuals have been involved. Individual genetic risk through establishment of a polygenic risk score based on 55 PC risk SNPs identified through the Finnish subset of the Collaborative Oncological Gene-Environment Study was assessed. Men with PC had significantly higher median polygenic risk score compared to the controls (6.59 vs. 3.83, P < 0.0001). The polygenic risk score above the control median was a significant predictor of PC (OR 2.13, 95% CI 1.90-2.39). The polygenic risk score predicted the risk of PC with an AUC of 0.618 (95% CI 0.60-0.63). Men in the highest polygenic risk score quartile were 2.8-fold (95% CI 2.4-3.30) more likely to develop PC compared with men in the lowest quartile. In the FinRSPC cohort, a significantly higher percentage of men had a PSA level of ≥ 4 ng/mL in polygenic risk score quartile four compared to quartile one (18.7% vs 8.3%, P < 0.00001). Adding the PRS to a PSA-only model contributed additional information in predicting PC in the FinRSPC model. Results strongly suggest that use of the polygenic risk score would facilitate the identification of men at increased risk for PC.",2020,The polygenic risk score predicted the risk of PC with an AUC of 0.618 (95% CI 0.60-0.63).,"['Finnish population-based retrospective study 2283 clinically diagnosed and 455 screen-detected patients from the Finnish Randomised Study of Screening for Prostate Cancer (FinRSPC), 2400 healthy individuals have been involved']",[],"['highest polygenic risk score quartile', 'polygenic risk score quartile', 'median polygenic risk score', 'PSA level of\u2009≥', 'polygenic risk score', 'PC (OR']","[{'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",2400.0,0.0680311,The polygenic risk score predicted the risk of PC with an AUC of 0.618 (95% CI 0.60-0.63).,"[{'ForeName': 'Csilla', 'Initials': 'C', 'LastName': 'Sipeky', 'Affiliation': 'Institute of Biomedicine, University of Turku, Kiinamyllynkatu 10, 20520, Turku, Finland.'}, {'ForeName': 'Kirsi M', 'Initials': 'KM', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Mass Screening Registry, Helsinki, Finland.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'Department of Urology, Tampere University Hospital and Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Unit of Health Sciences, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schleutker', 'Affiliation': 'Institute of Biomedicine, University of Turku, Kiinamyllynkatu 10, 20520, Turku, Finland. johanna.schleutker@utu.fi.'}]",Scientific reports,['10.1038/s41598-020-74172-z']
3199,33035593,Functional and cognitive responses to caffeine intake in middle-aged women are dose depending.,"Middle-aged women display many physiological and cognitive alterations resulting from aging and physical inactivity as well as other changes that occur as a function of menopause. Caffeine consumption is highest in this age with women having a particular greater sensitivity to caffeine than men. Its effects on functional and cognitive functions are controversial and seem to depend on the dose intake. This study aimed to assess the effect of low (100mg) and high (400mg) doses of caffeine consumption on cognitive (simple reaction time) and functional (upper and low body muscle endurance, aerobic endurance and functional mobility) performances. These performances were evaluated in 19 healthy middle-aged women by the 30-Second Chair Stand test for lower body muscle endurance, the 30sec Arm Curl Test for upper body muscle endurance, the 2-Minute Step test for aerobic endurance, The Timed Up and Go test for functional mobility and the simple reaction time test for reaction time, 60min after a treatment capsule intake (100mg caffeine/400mg caffeine/placebo). Low caffeine consumption significantly improved (p<.005) cognitive performance, while high caffeine consumption did not. However, the functional performance significantly improved (p<.05) after high caffeine consumption but not after low caffeine consumption. Except, the functional mobility performance significantly improved (p<.05) after both low and high caffeine consumption with better improvement (p<.05) after the high dose. In conclusion, low caffeine consumption improved cognitive performance and high caffeine consumption improved functional performance but the functional mobility improved after both low and high caffeine consumption in middleaged women.",2021,"However, the functional performance significantly improved (p<.05) after high caffeine consumption but not after low caffeine consumption.","['middleaged women', '19 healthy middle-aged women by the', 'middle-aged women', 'Middle-aged women']","['caffeine consumption', '30-Second Chair Stand test for lower body muscle endurance, the 30sec Arm Curl Test for upper body muscle endurance, the 2-Minute Step test for aerobic endurance, The Timed Up and Go test for functional mobility and the simple reaction time test for reaction time, 60min after a treatment capsule intake (100mg caffeine/400mg caffeine/placebo']","['Low caffeine consumption significantly improved (p<.005) cognitive performance', 'cognitive performance', 'Functional and cognitive responses', 'cognitive (simple reaction time) and functional (upper and low body muscle endurance, aerobic endurance and functional mobility) performances', 'functional mobility performance', 'Caffeine consumption', 'functional performance', 'functional mobility']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",19.0,0.026942,"However, the functional performance significantly improved (p<.05) after high caffeine consumption but not after low caffeine consumption.","[{'ForeName': 'Fatma Ben', 'Initials': 'FB', 'LastName': 'Waer', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia. Electronic address: fatmaelwaer123@gmail.com.'}, {'ForeName': 'Rabeb', 'Initials': 'R', 'LastName': 'Laatar', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'Jouira', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Srihi', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}, {'ForeName': 'Haithem', 'Initials': 'H', 'LastName': 'Rebai', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Sahli', 'Affiliation': 'Research Laboratory Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Tunisia.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112956']
3200,33049054,Midostaurin in patients with acute myeloid leukemia and FLT3-TKD mutations: a subanalysis from the RATIFY trial.,"The results from the RATIFY trial (ClinicalTrials.gov: NCT00651261; CALGB 10603) showed that midostaurin combined with standard chemotherapy significantly improved outcomes in patients with FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML), compared with placebo. In this post hoc subgroup analysis from the trial, we evaluated the impact of midostaurin in 163 patients with FLT3-tyrosine kinase domain (TKD) mutations. At a median follow-up of 60.7 months (95% CI, 55.0-70.8), the 5-year event-free survival (EFS) rate was significantly higher in patients treated with midostaurin than in those treated with placebo (45.2% vs 30.1%; P = .044). A trend toward improved disease-free survival was also observed with midostaurin (67.3% vs 53.4%; P = .089), whereas overall survival (OS) was similar in the 2 groups. Patients with AML and NPM1mut/FLT3-TKDmut or core binding factor (CBF)-rearranged/FLT3-TKDmut genotypes had significantly prolonged OS with or without censoring at hematopoietic cell transplantation (HCT), compared with NPM1WT/CBF-negative AMLs. The multivariable model for OS and EFS adjusted for allogeneic HCT in first complete remission as a time-dependent covariable, revealed NPM1 mutations and CBF rearrangements as significant favorable factors. These data show that NPM1 mutations or CBF rearrangements identify favorable prognostic groups in patients with FLT3-TKD AMLs, independent of other factors, also in the context of midostaurin treatment.",2020,"A trend toward improved disease-free survival was also observed with midostaurin (67.3% vs 53.4%; P = .089), whereas overall survival (OS) was similar in the 2 groups.","['163 patients with FLT3-tyrosine kinase domain (TKD) mutations', 'patients with acute myeloid leukemia and FLT3-TKD mutations', 'patients with FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML']","['placebo', 'midostaurin combined with standard chemotherapy', 'Midostaurin', 'midostaurin']","['5-year event-free survival (EFS) rate', 'disease-free survival', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0287186', 'cui_str': 'Fetal Liver Kinase-2'}, {'cui': 'C0033681', 'cui_str': 'Protein-tyrosine kinase'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0526371', 'cui_str': 'midostaurin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",163.0,0.0988437,"A trend toward improved disease-free survival was also observed with midostaurin (67.3% vs 53.4%; P = .089), whereas overall survival (OS) was similar in the 2 groups.","[{'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Voso', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Larson', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Marcucci', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Prior', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Krauter', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Medical School, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Medical School, Hannover, Germany.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Lavorgna', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Nomdedeu', 'Affiliation': 'Hematology Department, Hospital de la Santa Creu I Sant Pau and José Carreras Leukemia Research Institute, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Geyer', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, NY.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Walker', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Wei', 'Affiliation': 'Department of Clinical Hematology, Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sierra', 'Affiliation': 'Hematology Department, Hospital de la Santa Creu I Sant Pau and José Carreras Leukemia Research Institute, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Sanz', 'Affiliation': 'Department of Hematology, Hospital Universitari i Politecnic La Fe, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Brandwein', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Theo M', 'Initials': 'TM', 'LastName': 'de Witte', 'Affiliation': 'Department of Tumor Immunology, Nijmegen Centre of Life Sciences, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Joop H', 'Initials': 'JH', 'LastName': 'Jansen', 'Affiliation': 'Department of Tumor Immunology, Nijmegen Centre of Life Sciences, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Dietger', 'Initials': 'D', 'LastName': 'Niederwieser', 'Affiliation': 'Department of Hematology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Frederick R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Bruno C', 'Initials': 'BC', 'LastName': 'Medeiros', 'Affiliation': 'Division of Hematology, Stanford Comprehensive Cancer Center, Stanford University, Stanford, CA.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Tallman', 'Affiliation': 'Division of Hematologic Malignancies, Leukemia Service, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Medical School, Hannover, Germany.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Amadori', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'YinMiao', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Pallaud', 'Affiliation': 'Novaremed AG, Basel, Switzerland.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Du', 'Affiliation': 'Novartis Pharmaceuticals Corporation, Cambridge, MA.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Piciocchi', 'Affiliation': 'GIMEMA Data Center, Rome, Italy.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Ehninger', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus der TU Dresden, Dresden, Germany; and.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Byrd', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiede', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus der TU Dresden, Dresden, Germany; and.'}, {'ForeName': 'Konstanze', 'Initials': 'K', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Stone', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Clara D', 'Initials': 'CD', 'LastName': 'Bloomfield', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Lo-Coco', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}]",Blood advances,['10.1182/bloodadvances.2020002904']
3201,33049973,Effect of Added Sugar on the Consumption of A Lipid-Based Nutrient Supplement Among 7-24-Month-Old Children.,"Small-quantity lipid-based nutrient supplements (SQ-LNS) could help prevent malnutrition. Our primary objective was to examine the acceptability and consumption of sweetened and unsweetened versions of SQ-LNS before and after 14-days of repeated exposure. A total of 78 mother-infant dyads recruited from health centers in Morelos, Mexico, were randomized to two groups of SQ-LNS (sweetened, LNS-S; unsweetened, LNS-U). During the study, infants were fed SQ-LNS (20 g) mixed with 30 g of complementary food of the caregiver's choice. The amount of supplement-food mixture consumed was measured before, during and after a 14-day home exposure period. We defined acceptability as consumption of at least 50% of the offered food mixture. At initial exposure, LNS-U consumption was on average 44.0% (95% CI: 31.4, 58.5) and LNS-S 34.8% (25.3, 44.0); at final exposure, LNS-U and LNS-S consumption were 38.5% (27.8, 54.0) and 31.5% (21.6, 43.0). The average change in consumption did not differ between the groups (2.2 p.p. (-17.2, 24.4)). We conclude that the acceptability of sweetened and unsweetened SQ-LNS was low in this study population. Since consumption did not differ between supplement versions, we encourage the use of the unsweetened version given the potential effects that added sugar may have on weight gain especially in regions facing the double burden of malnutrition.",2020,The average change in consumption did not differ between the groups (2.2 p.p.,"['78 mother-infant dyads recruited from health centers in Morelos, Mexico', '7-24-Month-Old Children']","['Small-quantity lipid-based nutrient supplements (SQ-LNS', 'Added Sugar', 'SQ-LNS']","['acceptability and consumption of sweetened and unsweetened versions of SQ-LNS', 'average change in consumption', 'LNS-U consumption']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023374', 'cui_str': 'Lesch-Nyhan syndrome'}]",,0.147884,The average change in consumption did not differ between the groups (2.2 p.p.,"[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Okronipa', 'Affiliation': 'Institute of Global Nutrition, Department of Nutrition, University of California, Davis, 3135 Meyer Hall, One Shields Avenue, Davis, CA 95616, USA.'}, {'ForeName': 'Amado D', 'Initials': 'AD', 'LastName': 'Quezada-Sánchez', 'Affiliation': 'Center for Evaluation and Surveys Research, National Institute of Public Health, Avenida Universidad, Santa María Ahuacatitlán, Cuernavaca 62100, Mexico.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Johnson', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, School of Medicine, University of Colorado Anschutz Medical Campus, East 17th Place Mail Stop C225, Aurora, CO 80045, USA.'}, {'ForeName': 'Cloe', 'Initials': 'C', 'LastName': 'Rawlinson', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Avenida Universidad 655, Santa María Ahuacatitlán, Cuernavaca 62100, Mexico.'}, {'ForeName': 'Selene', 'Initials': 'S', 'LastName': 'Pacheco-Miranda', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Avenida Universidad 655, Santa María Ahuacatitlán, Cuernavaca 62100, Mexico.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Venosa López', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Avenida Universidad 655, Santa María Ahuacatitlán, Cuernavaca 62100, Mexico.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Gonzalez Navarrete', 'Affiliation': 'Global Alliance for Improved Nutrition, Rue de Vermont 37-39, 1202 Genève, Switzerland.'}, {'ForeName': 'Anabelle Bonvecchio', 'Initials': 'AB', 'LastName': 'Arenas', 'Affiliation': 'Center for Research in Nutrition and Health, National Institute of Public Health, Avenida Universidad 655, Santa María Ahuacatitlán, Cuernavaca 62100, Mexico.'}]",Nutrients,['10.3390/nu12103069']
3202,33050362,"Effects of Hyperbaric Oxygen Therapy on Inflammation, Oxidative/Antioxidant Balance, and Muscle Damage after Acute Exercise in Normobaric, Normoxic and Hypobaric, Hypoxic Environments: A Pilot Study.","The purpose of this study was to investigate the effects of hyperbaric oxygen therapy (HBOT) on inflammation, the oxidative/antioxidant balance, and muscle damage after acute exercise in normobaric, normoxic (NN) and hypobaric, hypoxic (HH) environments. Eighteen healthy males were selected and randomly assigned to three groups: exercise in NN conditions (NN group, n = 6), HBOT treatment after exercise in NN conditions (HNN group, n = 6), and HBOT treatment after exercise in HH conditions (HHH group, n = 6). All subjects performed treadmill running for 60 min at 75-80% maximum heart rate (HRmax) exercise intensity under each condition. The HBOT treatments consisted of breathing 100% oxygen at 2.5 atmosphere absolute (ATA) for 60 min. Blood samples were collected before exercise (BE), after exercise (AE), and after HBOT (AH) to examine inflammation (fibrinogen, interleukin-6 [IL-6], and tumor necrosis factor-α (TNF-α)), the oxidative/antioxidant balance (derivatives of reactive oxygen metabolites (d-ROMs) and the biological antioxidant potential (BAP)), and muscle damage (creatine kinase (CK) and lactate dehydrogenase (LDH)). Plasma fibrinogen, serum IL-6, CK, and LDH levels were significantly increased AE compared to BE in all groups ( p < 0.05). Plasma fibrinogen levels were significantly decreased AH compared to AE in all groups ( p < 0.05), and the HNN group had a significantly lower AH compared to BE ( p < 0.05). Serum IL-6 levels were significantly decreased AH compared to AE in the HNN and HHH groups ( p < 0.05). Serum CK levels were significantly decreased AH compared to AE in the HHH group ( p < 0.05). Serum LDH levels were significantly decreased AH compared to AE in the HNN and HHH groups ( p < 0.05), and the NN and HNN groups had significantly higher AH serum LDH levels compared to BE ( p < 0.05). These results suggest that acute exercise in both the NN and HH environments could induce temporary inflammatory responses and muscle damage, whereas HBOT treatment may be effective in alleviating exercise-induced inflammatory responses and muscle damage.",2020,"Plasma fibrinogen, serum IL-6, CK, and LDH levels were significantly increased AE compared to BE in all groups ( p < 0.05).",['Eighteen healthy males'],"['exercise in NN conditions (NN group, n = 6), HBOT treatment after exercise in NN conditions (HNN group, n = 6), and HBOT treatment after exercise in HH conditions (HHH group, n = 6', 'Hyperbaric Oxygen Therapy', 'treadmill running for 60 min at 75-80% maximum heart rate (HRmax) exercise intensity under each condition', 'hyperbaric oxygen therapy (HBOT']","['Serum IL-6 levels', 'AH serum LDH levels', 'Plasma fibrinogen, serum IL-6, CK, and LDH levels', 'Inflammation, Oxidative/Antioxidant Balance, and Muscle Damage', 'inflammation, the oxidative/antioxidant balance, and muscle damage after acute exercise in normobaric, normoxic (NN) and hypobaric, hypoxic (HH) environments', 'Serum LDH levels', 'inflammation (fibrinogen, interleukin-6 [IL-6], and tumor necrosis factor-α (TNF-α)), the oxidative/antioxidant balance (derivatives of reactive oxygen metabolites (d-ROMs) and the biological antioxidant potential (BAP)), and muscle damage (creatine kinase (CK) and lactate dehydrogenase (LDH', 'Serum CK levels', 'Plasma fibrinogen levels']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0268540', 'cui_str': 'Hyperornithinemia-hyperammonemia-homocitrullinuria syndrome'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0856510', 'cui_str': 'Plasma fibrinogen'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C4049351', 'cui_str': 'Biological antioxidant potential'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}]",18.0,0.0181581,"Plasma fibrinogen, serum IL-6, CK, and LDH levels were significantly increased AE compared to BE in all groups ( p < 0.05).","[{'ForeName': 'Jinhee', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Jae-Hee', 'Initials': 'JH', 'LastName': 'Min', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Yul-Hyo', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Taekwondo, Youngsan University, Yangsan-si 50510, Korea.'}, {'ForeName': 'Hee-Tae', 'Initials': 'HT', 'LastName': 'Roh', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17207377']
3203,33052754,Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer.,"PURPOSE
Sentinel node (SN) biopsy is accurate in operable oral and oropharyngeal cT1-T2N0 cancer (OC), but, to our knowledge, the oncologic equivalence of SN biopsy and neck lymph node dissection (ND; standard treatment) has never been evaluated.
METHODS
In this phase III multicenter trial, 307 patients with OC were randomly assigned to (1) the ND arm or (2) the SN arm (experimental arm: biopsy alone if negative, or followed by ND if positive, during primary tumor surgery). The primary outcome was neck node recurrence-free survival (RFS) at 2 years. Secondary outcomes were 5-year neck node RFS, 2- and 5-year disease-specific survival (DSS), and overall survival (OS). Other outcomes were hospital stay length, neck and shoulder morbidity, and number of physiotherapy prescriptions during the 2 years after surgery.
RESULTS
Data on 279 patients (139 ND and 140 SN) could be analyzed. Neck node RFS was 89.6% (95% CI, 0.83% to 0.94%) at 2 years in the ND arm and 90.7% (95% CI, 0.84% to 0.95%) in the SN arm, confirming the equivalence with P < .01. The 5-year RFS and the 2- and 5-year DSS and OS were not significantly different between arms. The median hospital stay length was 8 days in the ND arm and 7 days in the SN arm ( P < .01). The functional outcomes were significantly worse in the ND arm until 6 months after surgery.
CONCLUSION
This study demonstrated the oncologic equivalence of the SN and ND approaches, with lower morbidity in the SN arm during the first 6 months after surgery, thus establishing SN as the standard of care in OC.",2020,The 5-year RFS and the 2- and 5-year DSS and OS were not significantly different between arms.,"['Operable T1-T2N0 Oral and Oropharyngeal Cancer', '307 patients with OC', '279 patients (139 ND and 140 SN']","['SN arm (experimental arm: biopsy alone if negative, or followed by ND if positive, during primary tumor surgery', 'Sentinel node (SN) biopsy', 'Sentinel Node Biopsy Versus Neck Node Dissection']","['hospital stay length, neck and shoulder morbidity, and number of physiotherapy prescriptions', '5-year RFS and the 2- and 5-year DSS and OS', 'Neck node RFS', 'median hospital stay length', 'neck node recurrence-free survival (RFS', '5-year neck node RFS, 2- and 5-year disease-specific survival (DSS), and overall survival (OS']","[{'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}]","[{'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0011195', 'cui_str': 'Déjérine-Sottas disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",307.0,0.134481,The 5-year RFS and the 2- and 5-year DSS and OS were not significantly different between arms.,"[{'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Garrel', 'Affiliation': 'Head Neck Surgery Department, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Poissonnet', 'Affiliation': 'Head Neck Surgery Department, Antoine Lacassagne Center, Nice, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Moyà Plana', 'Affiliation': 'Head Neck Surgery Department, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Fakhry', 'Affiliation': 'Head Neck Surgery Department, Marseille University Hospital Center, Marseille, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Dolivet', 'Affiliation': 'Head Neck Surgery Department, Alexis Vautrin Center, Vandœuvre-lès-Nancy, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lallemant', 'Affiliation': 'Head Neck Surgery Department, Nîmes University Hospital Center, Nîmes, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Sarini', 'Affiliation': 'Head Neck Surgery Department, Toulouse Oncopole, Toulouse, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Vergez', 'Affiliation': 'Head Neck Surgery Department, Toulouse Oncopole, Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Guelfucci', 'Affiliation': 'Head Neck Surgery Department, Toulon Hospital Center, Toulon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Choussy', 'Affiliation': 'Head Neck Surgery Department, Curie Institute, Paris, France.'}, {'ForeName': 'Vianney', 'Initials': 'V', 'LastName': 'Bastit', 'Affiliation': 'Head Neck Surgery Department, François Baclesse Center, Caen, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Richard', 'Affiliation': 'Head Neck Surgery Department, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Costes', 'Affiliation': 'Pathology Department, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Landais', 'Affiliation': 'Clinical Research University Institute, UPRES EA 2415, Montpellier, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Perriard', 'Affiliation': 'Clinical Research University Institute, UPRES EA 2415, Montpellier, France.'}, {'ForeName': 'Jean Pierre', 'Initials': 'JP', 'LastName': 'Daures', 'Affiliation': 'Clinical Research University Institute, UPRES EA 2415, Montpellier, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'de Verbizier', 'Affiliation': 'Nuclear Medicine Department, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Favier', 'Affiliation': 'Head Neck Surgery Department, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'de Boutray', 'Affiliation': 'Head Neck Surgery Department, Montpellier University Hospital Center, Montpellier, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01661']
3204,33052785,"Re: Group-Based vs Individual Pelvic Floor Muscle Training to Treat Urinary Incontinence in Women, a Randomized Clinical Trial.",,2020,,[],['Individual Pelvic Floor Muscle Training'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]",[],,0.0714689,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001286.02']
3205,33052786,"Re: Safety and Efficacy of Mirabegron: Analysis of a Large Integrated Clinical Trial Database of Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or Placebo.",,2020,,"['Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or']","['Mirabegron', 'Placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}]","[{'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.184078,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001286']
3206,33062081,The Effect of Adding Neuromuscular Electrical Stimulation with Endurance and Resistance Training on Exercise Capacity and Balance in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial.,"This study investigated the effectiveness of adding neuromuscular electrical stimulation (NMES) to endurance training (ET) and resistance training (RT) on exercise tolerance and balance in COPD patients. 42 patients were assigned randomly to the ET + RT + NMES group ( n = 22) or ET + RT group ( n = 20). Two training programs were performed including 72 sessions. The center of pressure (CoP) displacement in the mediolateral direction (CoPML), in the anteroposterior direction (CoPAP), and the center of pressure velocity (CoPV) were recorded using a stabilometric platform with eyes open (EO) and eyes closed (EC). Time up and go and Berg Balance Scale tests, 6-minute walking test (6MWT), and the maximal voluntary contraction (MVC) were measured before and after the intervention. The walking distance, the dyspnea, and the heart rate were improved after the training period ( p < 0.001) for both groups ( p < 0.05). The ET + RT + NMES group showed better improvement than the ET + RT group in terms of 6MWD. CoP ML , CoP AP , and CoP V were significantly ( p < 0.001; p < 0.05; p < 0.001, respectively) more improved in EO and EC conditions in the ET + RT + NMES group than the ET + RT group. BBS, TUG, and MVC values improved in both groups after the training ( p < 0.001). The performances in TUG and MVC tests were significantly greater in the ET + RT + NMES group than those in the ET + RT group ( p < 0.01; p < 0.001, respectively). Combining NMES, RT, and ET improves balance in patients with COPD.",2020,The ET + RT + NMES group showed better improvement than the ET + RT group in terms of 6MWD.,"['COPD patients', '42 patients', 'patients with COPD', 'Patients with Chronic Obstructive Pulmonary Disease']","['Neuromuscular Electrical Stimulation with Endurance and Resistance Training', 'neuromuscular electrical stimulation (NMES) to endurance training (ET) and resistance training (RT', 'NMES, RT, and ET', 'ET\u2009+\u2009RT', 'stabilometric platform with eyes open (EO) and eyes closed (EC', 'ET\u2009+\u2009RT\u2009+\u2009NMES']","['Exercise Capacity and Balance', 'exercise tolerance and balance', 'BBS, TUG, and MVC values', 'performances in TUG and MVC tests', 'Time up and go and Berg Balance Scale tests, 6-minute walking test (6MWT), and the maximal voluntary contraction (MVC', 'EO and EC conditions', 'walking distance, the dyspnea, and the heart rate', 'CoP ML , CoP AP , and CoP V']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}]",42.0,0.0181182,The ET + RT + NMES group showed better improvement than the ET + RT group in terms of 6MWD.,"[{'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Acheche', 'Affiliation': ""Laboratoire de Recherche Physiologie de l'Exercice et Physiopathologie: de l'intégré au moléculaire « Biologie, Médecine et Santé » (LR19ES09), Faculté de Médecine de Sousse, Sousse 4002, Tunisia.""}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Mekki', 'Affiliation': ""Laboratoire de Recherche Physiologie de l'Exercice et Physiopathologie: de l'intégré au moléculaire « Biologie, Médecine et Santé » (LR19ES09), Faculté de Médecine de Sousse, Sousse 4002, Tunisia.""}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Paillard', 'Affiliation': ""Movement, Balance, Performance and Health Laboratory (EA 4445), University of Pau and des Pays de l'Adour, Pau 64012, France.""}, {'ForeName': 'Zouhair', 'Initials': 'Z', 'LastName': 'Tabka', 'Affiliation': ""Laboratoire de Recherche Physiologie de l'Exercice et Physiopathologie: de l'intégré au moléculaire « Biologie, Médecine et Santé » (LR19ES09), Faculté de Médecine de Sousse, Sousse 4002, Tunisia.""}, {'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Trabelsi', 'Affiliation': ""Laboratoire de Recherche Physiologie de l'Exercice et Physiopathologie: de l'intégré au moléculaire « Biologie, Médecine et Santé » (LR19ES09), Faculté de Médecine de Sousse, Sousse 4002, Tunisia.""}]",Canadian respiratory journal,['10.1155/2020/9826084']
3207,33063270,Efficacy and Safety of Tofogliflozin and Ipragliflozin for Patients with Type-2 Diabetes: A Randomized Crossover Study by Flash Glucose Monitoring.,"INTRODUCTION
Sodium-glucose cotransporter 2 (SGLT2) inhibitors promote urinary glucose excretion. However, the differences in the effects of various SGLT2 inhibitors are unknown. We used flash glucose monitoring (FGM) to identify the differences between tofogliflozin and ipragliflozin in terms of efficacy in reducing glycemic variability and mitigate hypoglycemia risk.
METHODS
In this crossover study, 24 patients with type-2 diabetes mellitus (T2DM) receiving insulin glargine U300 therapy were randomly allocated to tofogliflozin and ipragliflozin or ipragliflozin and tofogliflozin group. Glycemic variability and hypoglycemia were compared using to the 3-day FGM data per treatment period.
RESULTS
Glucose level 2 h after each meal was significantly lower with tofogliflozin administration than with ipragliflozin administration. Time below the target glucose range after tofogliflozin administration was significantly lower than that after ipragliflozin administration (2.1% ± 4.4% vs. 8.7% ± 11.7%). The 24-h standard deviation of glucose level, mean amplitude of glycemic excursion, and mean percent time with nocturnal hypoglycemia after tofogliflozin administration were significantly lower than those after ipragliflozin administration.
CONCLUSIONS
Tofogliflozin was more effective and safer than ipragliflozin in reducing glycemic variability and mitigating hypoglycemia risk in patients with T2DM treated with insulin glargine U300.
TRIAL REGISTRATION
This trial was registered at the University Hospital Medical Information Network Clinical Trial Registry (no. UMIN000037158).",2020,Time below the target glucose range after tofogliflozin administration was significantly lower than that after ipragliflozin administration (2.1% ± 4.4% vs. 8.7% ± 11.7%).,"['24 patients with type-2 diabetes mellitus (T2DM) receiving insulin glargine U300 therapy', 'patients with T2DM treated with insulin glargine U300', 'Patients with Type-2 Diabetes']","['flash glucose monitoring (FGM', 'ipragliflozin', 'tofogliflozin and ipragliflozin or ipragliflozin and tofogliflozin group', 'tofogliflozin', 'Tofogliflozin', 'Tofogliflozin and Ipragliflozin', 'Sodium-glucose cotransporter 2 (SGLT2) inhibitors', 'tofogliflozin and ipragliflozin', 'Flash Glucose Monitoring']","['24-h standard deviation of glucose level, mean amplitude of glycemic excursion, and mean percent time with nocturnal hypoglycemia after tofogliflozin administration', 'glycemic variability and mitigating hypoglycemia risk', 'Efficacy and Safety', 'Glycemic variability and hypoglycemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0342315', 'cui_str': 'Nocturnal hypoglycemia'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",24.0,0.0292529,Time below the target glucose range after tofogliflozin administration was significantly lower than that after ipragliflozin administration (2.1% ± 4.4% vs. 8.7% ± 11.7%).,"[{'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Internal Medicine, Minami Osaka Hospital, 1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan. y.kawaguchi@minamiosaka.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sawa', 'Affiliation': 'Department of Internal Medicine, Minami Osaka Hospital, 1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan.'}, {'ForeName': 'Yasuro', 'Initials': 'Y', 'LastName': 'Kumeda', 'Affiliation': 'Department of Internal Medicine, Minami Osaka Hospital, 1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00940-9']
3208,33050945,The Efficacy of Famotidine in improvement of outcomes in Hospitalized COVID-19 Patients: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES
This study aims to investigate the effect of Famotidine on the recovery process of COVID-19 patients.
TRIAL DESIGN
This phase III randomized clinical trial was designed with two parallel arms, placebo-controlled, single-blind, and concealed allocation.
PARTICIPANTS
All COVID-19 patients admitted to Shahid Mohammadi Hospital in Bandar Abbas whose PCR test results are positive for SARS-Cov-2 and sign the written consent of the study are included in the study and immunocompromised patients, end-stage renal disease, moderate renal failure (clearance Creatinine 30 to 50 ml/min) or stage 4 severe chronic kidney disease or need for dialysis (creatinine clearance lesser than 30 ml/min), history of liver disease, hepatitis C infection or alcoholism, Glucose 6 phosphate dehydrogenase deficiency(G6PD), the ratio of Alanine transaminase to Aspartate transaminase 5 times above the normal limit, history or evidence of long QT segment on Electrocardiogram, psoriasis or porphyria, pregnancy, use of oral contraceptives, Dasatinib, Neratinib, Ozanimod, Pazopanib, Rilpivirine, Siponimod and/or Tizanidine and allergies to any study drug are excluded.
INTERVENTION AND COMPARATOR
Intervention group receives standard pharmacotherapy according to the treatment protocols of the National Committee of COVID-19 and oral famotidine 160 mg (Manufactured by Chemidarou Pharmaceutical Company) four times a day until the day of discharge, for a maximum of fourteen days. Comparator group receives standard drug therapy according to the treatment protocols of the National Committee of COVID-19 and placebo in the same dosage.
MAIN OUTCOMES
Patients' temperature, respiration rate, oxygen saturation, lung infiltration, lactate dehydrogenase and complete blood count were measured at the baseline (before the intervention) and on day 14 after the intervention or on the discharge day.
RANDOMISATION
The person who has no role in admitting patients and assigning patients to random codes preparing random sequences using online tools and by permuted block randomization method. Eligibility criteria are monitored by the person responsible for admitting patients. Codes in a random sequence are assigned to patients by the treatment team without knowing that each code is in the intervention or comparator group. Patient codes are then matched to randomly generated sequence information for interventions.
BLINDING (MASKING)
All participants are unaware of which group of this study they are in and after grouping patients in the groups, Patients receive Famotidine in the treatment group and receive a placebo in the control group. The lead researcher, care givers, data collectors, and outcome assessors are aware of the grouping of patients.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
As there is no prior work on this research question, so no assumptions for the sample size calculation could be made. A total of 20 patients participate in this study, which are randomly divided into two groups of 10 as intervention or control groups.
TRIAL STATUS
Version 3 of the protocol was approved by the Deputy of Research and Technology and the ethics committee of Hormozgan University of Medical Sciences on August 2, 2020, with the local code 990245, and the recruitment started on August 17, 2020. recruitment ended on August 31, 2020. Since the recruitment ended earlier than expected (the expected recruitment end date was 21/12/2020), we submitted post recruitment but prior to publication of the results.
TRIAL REGISTRATION
The protocol was registered before starting subject recruitment under the title: The effect of Famotidine on the improvement of patients with COVID-19, IRCT20200509047364N2, at Iranian Registry of clinical trials ( https://www.irct.ir/trial/49657 ) on 17 August 2020.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"The effect of Famotidine on the improvement of patients with COVID-19, IRCT20200509047364N2, at Iranian Registry of clinical trials ( https://www.irct.ir/trial/49657 ) on 17 August 2020.
","['20 patients participate in this study', 'immunocompromised patients, end-stage renal disease, moderate renal failure (clearance Creatinine 30 to 50 ml/min) or stage 4 severe chronic kidney disease or need for dialysis (creatinine clearance lesser than 30 ml/min), history of liver disease, hepatitis C infection or alcoholism, Glucose 6 phosphate dehydrogenase deficiency(G6PD), the ratio of Alanine transaminase to Aspartate transaminase 5 times above the normal limit, history or evidence of long QT segment on Electrocardiogram, psoriasis or porphyria, pregnancy, use of oral contraceptives, Dasatinib, Neratinib, Ozanimod', 'Version 3 of the protocol was approved by the Deputy of Research and Technology and the ethics committee of Hormozgan University of Medical Sciences on August 2, 2020, with the local code 990245, and the recruitment started on August 17, 2020', 'All COVID-19 patients admitted to Shahid Mohammadi Hospital in Bandar Abbas', 'Hospitalized COVID-19 Patients', 'patients with COVID-19, IRCT20200509047364N2, at Iranian Registry of clinical trials ( https://www.irct.ir/trial/49657 ) on 17 August 2020', 'COVID-19 patients']","['COVID-19 and placebo', 'placebo', 'COVID-19 and oral famotidine 160 mg (Manufactured by Chemidarou Pharmaceutical Company', 'Pazopanib, Rilpivirine', 'Famotidine']","['temperature, respiration rate, oxygen saturation, lung infiltration, lactate dehydrogenase and complete blood count']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0455550', 'cui_str': 'H/O: liver disease'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0017757', 'cui_str': 'Glucose-6-phosphate dehydrogenase'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C1291311', 'cui_str': 'Deficiency of dehydrogenase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442816', 'cui_str': 'Normal limits'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0032708', 'cui_str': 'Disorder of porphyrin metabolism'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C2713008', 'cui_str': 'neratinib'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015620', 'cui_str': 'Famotidine'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}]",20.0,0.0960359,"The effect of Famotidine on the improvement of patients with COVID-19, IRCT20200509047364N2, at Iranian Registry of clinical trials ( https://www.irct.ir/trial/49657 ) on 17 August 2020.
","[{'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Samimagham', 'Affiliation': 'Clinical Research Development Center, Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hassani Azad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Haddad', 'Affiliation': 'Clinical Research Development Center, Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Arabi', 'Affiliation': 'Department of Internal Medicine and Public Health Research Center, Family Medicine Department, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Dariush', 'Initials': 'D', 'LastName': 'Hooshyar', 'Affiliation': 'Student Research Committee, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'KazemiJahromi', 'Affiliation': 'Endocrinology and Metabolism Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. mitra.kazemijahromi@gmail.com.'}]",Trials,['10.1186/s13063-020-04773-6']
3209,33049392,"As-Needed Versus Regular Use of Fluticasone Furoate Nasal Spray in Patients with Moderate to Severe, Persistent, Perennial Allergic Rhinitis: A Randomized Controlled Trial.","BACKGROUND
Using intranasal corticosteroid (INCS) regularly is recommended for treating perennial allergic rhinitis. However, no studies have evaluated ""as-needed"" use.
OBJECTIVE
To compare the efficacy between as-needed and regular use of INCS in patients with moderate to severe perennial allergic rhinitis.
METHODS
In a 6-week randomized controlled trial, participants were assigned to either fluticasone furoate (FF) nasal spray, (27.5 μg) 2 sprays once daily for 1 week, followed by as-needed use (FF-as-needed) for 5 more weeks or 2 sprays once daily for 6 weeks (FF-regular). The primary outcome was a change in the total nasal symptom score (TNSS). The secondary outcomes were the change in nasal peak inspiratory flow, Rhinoconjunctivitis Quality of Life-36 Questionnaire score, and cumulative FF dose.
RESULTS
In total of 108 patients, 53 and 55 patients were randomized to the FF-as-needed and FF-regular group, respectively. The difference in mean change in TNSS between the 2 groups was not significant at week 6 (1.21 points; 95% CI, -0.08 to 2.49; P = .066). The FF-regular group tended toward a greater improvement in TNSS. The FF-regular group had a higher mean change in nasal peak inspiratory flow than the FF-as-needed group at week 6 (-19.21 L/min; 95% CI, -33.54 to -4.89; P = .009). Both groups had similar improvement in Rhinoconjunctivitis Quality of Life-36 Questionnaire. The mean cumulative FF dose in the FF-as-needed group was 51% that of the FF-regular group.
CONCLUSIONS
Both as-needed and regular use of INCS had similar improvement in TNSS and RCQ-36 score in patients with perennial allergic rhinitis. As-needed use had half of INCS exposure of the regular use.",2020,Both as-needed and regular use of INCS had similar improvement in TNSS and RCQ-36 in PAR patients.,"['Patients With Moderate to Severe, Persistent, Perennial Allergic Rhinitis', 'moderate-to-severe PAR patients', 'perennial allergic rhinitis (PAR', 'One hundred and three patients, 51 in FF-as-needed and 52 in FF-regular, completed the study']","['intranasal corticosteroid (INCS', 'INCS', 'fluticasone furoate (FF) nasal spray', 'Fluticasone Furoate Nasal Spray']","['mean change of NPIF', 'RCQ-36', 'change in nasal peak inspiratory flow (NPIF), Rhinoconjunctivitis Quality of Life-36 Questionnaire Score (RCQ-36), and cumulative FF dose', 'TNSS and RCQ-36', 'mean change of TNSS', 'TNSS', 'mean cumulative FF dose', 'total nasal symptom score (TNSS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0429205', 'cui_str': 'Nasal peak inspiratory flow'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}]",103.0,0.192399,Both as-needed and regular use of INCS had similar improvement in TNSS and RCQ-36 in PAR patients.,"[{'ForeName': 'Torpong', 'Initials': 'T', 'LastName': 'Thongngarm', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chamard', 'Initials': 'C', 'LastName': 'Wongsa', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Phichayut', 'Initials': 'P', 'LastName': 'Phinyo', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; Center for Clinical Epidemiology and Clinical Statistics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; Musculoskeletal Science and Translational Research (MSTR), Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Paraya', 'Initials': 'P', 'LastName': 'Assanasen', 'Affiliation': 'Division of Rhinology and Allergy, Department of Otorhinolaryngology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pongsakorn', 'Initials': 'P', 'LastName': 'Tantilipikorn', 'Affiliation': 'Division of Rhinology and Allergy, Department of Otorhinolaryngology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Mongkhon', 'Initials': 'M', 'LastName': 'Sompornrattanaphan', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. Electronic address: mongkhon.som@mahidol.ac.th.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.09.057']
3210,33050115,Attention Networks in ADHD Adults after Working Memory Training with a Dual n -Back Task.,"Patients affected by Attention-Deficit/Hyperactivity Disorder (ADHD) are characterized by impaired executive functioning and/or attention deficits. Our study aim is to determine whether the outcomes measured by the Attention Network Task (ANT), i.e., the reaction times (RTs) to specific target and cue conditions and alerting, orienting, and conflict (or executive control) effects are affected by cognitive training with a Dual n -back task. We considered three groups of young adult participants: ADHD patients without medication (ADHD), ADHD with medication (MADHD), and age/education-matched controls. Working memory training consisted of a daily practice of 20 blocks of Dual n -back task (approximately 30 min per day) for 20 days within one month. Participants of each group were randomly assigned into two subgroups, the first one with an adaptive mode of difficulty ( adaptive training), while the second was blocked at the level 1 during the whole training phase (1-back task, baseline training). Alerting and orienting effects were not modified by working memory training. The dimensional analysis showed that after baseline training, the lesser the severity of the hyperactive-impulsive symptoms, the larger the improvement of reaction times on trials with high executive control/conflict demand (i.e., what is called Conflict Effect ), irrespective of the participants' group. In the categorical analysis, we observed the improvement in such Conflict Effect after the adaptive training in adult ADHD patients irrespective of their medication, but not in controls. The ex-Gaussian analysis of RT and RT variability showed that the improvement in the Conflict Effect correlated with a decrease in the proportion of extreme slow responses. The Dual n -back task in the adaptive mode offers as a promising candidate for a cognitive remediation of adult ADHD patients without pharmaceutical medication.",2020,Alerting and orienting effects were not modified by working memory training.,"['adult ADHD patients without pharmaceutical medication', 'young adult participants: ADHD patients without medication (ADHD), ADHD with medication (MADHD), and age/education-matched controls', 'ADHD Adults after Working Memory Training with a Dual n -Back Task']","['cognitive training with a Dual n -back task', 'adaptive mode of difficulty ( adaptive training), while the second was blocked at the level 1 during the whole training phase (1-back task, baseline training']","['proportion of extreme slow responses', 'severity of the hyperactive-impulsive symptoms', 'reaction times (RTs) to specific target and cue conditions and alerting, orienting, and conflict (or executive control) effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0316141,Alerting and orienting effects were not modified by working memory training.,"[{'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Dotare', 'Affiliation': 'School of Medicine, Yamaguchi University, 1-1-1 Minami-kogushi, Ube, Yamaguchi 755-8505, Japan.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Bader', 'Affiliation': 'Department of Psychiatry -SUPEA, University Hospital of Lausanne, CH-1004 Lausanne, Switzerland.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Mesrobian', 'Affiliation': 'NeuroHeuristic Research Group, HEC-Lausanne, University of Lausanne, Quartier UNIL-Chamberonne, CH-1015 Lausanne, Switzerland.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Asai', 'Affiliation': 'Department of Systems Bioinformatics, Graduate School of Medicine, Yamaguchi University, 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan.'}, {'ForeName': 'Alessandro E P', 'Initials': 'AEP', 'LastName': 'Villa', 'Affiliation': 'NeuroHeuristic Research Group, HEC-Lausanne, University of Lausanne, Quartier UNIL-Chamberonne, CH-1015 Lausanne, Switzerland.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Lintas', 'Affiliation': 'NeuroHeuristic Research Group, HEC-Lausanne, University of Lausanne, Quartier UNIL-Chamberonne, CH-1015 Lausanne, Switzerland.'}]",Brain sciences,['10.3390/brainsci10100715']
3211,33050169,Acute Effects of Metformin and Vildagliptin after a Lipid-Rich Meal on Postprandial Microvascular Reactivity in Patients with Type 2 Diabetes and Obesity: A Randomized Trial.,"BACKGROUND
Type 2 diabetes mellitus and obesity are both related to endothelial dysfunction. Postprandial lipemia is a cardiovascular risk. Notably, it is known that a high-fat diet may elicit microvascular dysfunction, even in healthy subjects. Since anti-diabetic drugs have different mechanisms of action and also distinct vascular benefits, we aimed to compare the results of two anti-diabetic drugs after the intake of a lipid-rich meal on microcirculation in patients with type 2 diabetes and obesity. In parallel, we also investigated the metabolic profile, oxidative stress, inflammation, plasma viscosity, and some gastrointestinal peptides.
SUBJECTS/METHODS
We included 38 drug-naïve patients, all women aged between 19 and 50 years, with BMI ≥ 30 kg/m 2 . We performed endothelial measurements and collected samples before (fasting) and after the intake of a lipid-rich meal at 30, 60, 120, and 180 min. Patients were randomized to metformin or vildagliptin, given orally just before the meal. Endothelial function was assessed by videocapillaroscopy and laser-Doppler flowmetry to investigate microvascular reactivity. Besides, we also investigated plasma viscosity, inflammatory and oxidative stress biomarkers, gastrointestinal peptides, and metabolic profile in all time points.
RESULTS
No differences at baseline were noted between groups. Vildagliptin increased glucagon-like peptide-1 compared to metformin. Paired comparisons showed that, during the postprandial period, vildagliptin significantly changed levels of insulin and glucagon-like peptide-1, and also the dipeptidyl peptidase-4 activity, while metformin had effects on plasma glucose solely. Metformin use during the test meal promoted an increase in functional capillary density, while vildagliptin kept non-nutritive microvascular blood flow and vasomotion unchanged.
CONCLUSIONS
After the intake of a lipid-rich meal, the use of vildagliptin preserved postprandial non-nutritive microflow and vasomotion, while metformin increased capillary recruitment, suggesting protective and different mechanisms of action on microcirculation.",2020,Vildagliptin increased glucagon-like peptide-1 compared to metformin.,"['Patients with Type 2 Diabetes and Obesity', '38 drug-naïve patients, all women aged between 19 and 50 years, with BMI ≥ 30 kg/m 2 ', 'patients with type 2 diabetes and obesity', 'healthy subjects']","['vildagliptin', 'Vildagliptin', 'metformin or vildagliptin', 'metformin', 'Metformin and Vildagliptin', 'lipid-rich meal', 'videocapillaroscopy and laser-Doppler flowmetry', 'Lipid-Rich Meal', 'Metformin']","['plasma viscosity, inflammatory and oxidative stress biomarkers, gastrointestinal peptides, and metabolic profile', 'metabolic profile, oxidative stress, inflammation, plasma viscosity, and some gastrointestinal peptides', 'Postprandial Microvascular Reactivity', 'functional capillary density, while vildagliptin kept non-nutritive microvascular blood flow and vasomotion unchanged', 'plasma glucose solely', 'Endothelial function', 'levels of insulin and glucagon-like peptide-1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3652744', 'cui_str': 'metformin and vildagliptin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C4045986', 'cui_str': 'Videocapillaroscopy'}, {'cui': 'C0162520', 'cui_str': 'Laser doppler flowmetry'}]","[{'cui': 'C0427685', 'cui_str': 'Plasma viscosity measurement'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",,0.0239451,Vildagliptin increased glucagon-like peptide-1 compared to metformin.,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Schiappacassa', 'Affiliation': 'Post-Graduate Program in Clinical and Experimental Physiopathology (FISCLINEX), Faculty of Medical Sciences, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}, {'ForeName': 'Priscila A', 'Initials': 'PA', 'LastName': 'Maranhão', 'Affiliation': 'Post-Graduate Program in Clinical and Experimental Physiopathology (FISCLINEX), Faculty of Medical Sciences, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}, {'ForeName': 'Maria das Graças Coelho de', 'Initials': 'MDGC', 'LastName': 'Souza', 'Affiliation': 'Post-Graduate Program in Clinical and Experimental Physiopathology (FISCLINEX), Faculty of Medical Sciences, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}, {'ForeName': 'Diogo G', 'Initials': 'DG', 'LastName': 'Panazzolo', 'Affiliation': 'Post-Graduate Program in Clinical and Experimental Physiopathology (FISCLINEX), Faculty of Medical Sciences, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}, {'ForeName': 'José Firmino', 'Initials': 'JF', 'LastName': 'Nogueira Neto', 'Affiliation': 'Lipids Laboratory (Lablip), Policlínica Piquet Carneiro, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-003, Brazil.'}, {'ForeName': 'Eliete', 'Initials': 'E', 'LastName': 'Bouskela', 'Affiliation': 'Laboratory of Clinical and Experimental Research on Vascular Biology (BioVasc), Biomedical Center, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}, {'ForeName': 'Luiz Guilherme', 'Initials': 'LG', 'LastName': 'Kraemer-Aguiar', 'Affiliation': 'Laboratory of Clinical and Experimental Research on Vascular Biology (BioVasc), Biomedical Center, State University of Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.'}]",Journal of clinical medicine,['10.3390/jcm9103228']
3212,33050179,Effectiveness of a Physical Therapeutic Exercise Programme for Caregivers of Dependent Patients: A Pragmatic Randomised Controlled Trial from Spanish Primary Care.,"Female family caregivers (FFCs) constitute one of the basic supports of socio-health care for dependence in developed countries. The care provided by FFCs may impact their physical and mental health, negatively affecting their quality of life. In order to alleviate the consequences of providing care on FFCs, the Spanish Public Health System has developed the family caregiver care programme (FCCP) to be applied in primary care (PC) centres. The effectiveness of this programme is limited. To date, the addition of a physical therapeutic exercise (PTE) programme to FCCP has not been evaluated. A randomised multicentre clinical trial was carried out in two PC centres of the Spanish Public Health System. In total, 68 FFCs were recruited. The experimental group (EG) performed the usual FCCP (4 sessions, 6 h) added to a PTE programme (36 sessions in 12 weeks) whereas the control group performed the usual FCCP performed in PC. The experimental treatment improved quality of life (d = 1.17 in physical component summary), subjective burden (d = 2.38), anxiety (d = 1.52), depression (d = 1.37) and health-related physical condition (d = 2.44 in endurance). Differences between the groups ( p < 0.05) were clinically relevant in favour of the EG. The experimental treatment generates high levels of satisfaction.",2020,"The experimental treatment improved quality of life (d = 1.17 in physical component summary), subjective burden (d = 2.38), anxiety (d = 1.52), depression (d = 1.37) and health-related physical condition (d = 2.44 in endurance).","['Caregivers of Dependent Patients', 'two PC centres of the Spanish Public Health System', 'In total, 68 FFCs were recruited', 'Female family caregivers (FFCs']","['physical therapeutic exercise (PTE) programme', 'usual FCCP (4 sessions, 6 h) added to a PTE programme', 'usual FCCP performed in PC', 'Physical Therapeutic Exercise Programme']","['health-related physical condition', 'quality of life', 'subjective burden', 'anxiety']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",68.0,0.0437757,"The experimental treatment improved quality of life (d = 1.17 in physical component summary), subjective burden (d = 2.38), anxiety (d = 1.52), depression (d = 1.37) and health-related physical condition (d = 2.44 in endurance).","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Montero-Cuadrado', 'Affiliation': 'Unit for Active Coping Strategies for Pain in Primary Care, East-Valladolid Primary Care Management, Castilla and Leon Public Health System (Sacyl), 47011 Valladolid, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Galán-Martín', 'Affiliation': 'Unit for Active Coping Strategies for Pain in Primary Care, East-Valladolid Primary Care Management, Castilla and Leon Public Health System (Sacyl), 47011 Valladolid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sánchez-Sánchez', 'Affiliation': 'Department of Physical Activity and Sports Sciences, University Pontificia of Salamanca, 37002 Salamanca, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Lluch', 'Affiliation': 'Department of Physical Therapy, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Mayo-Iscar', 'Affiliation': 'Department of Statistics and Operational Research and IMUVA, University of Valladolid, 47005 Valladolid, Spain.'}, {'ForeName': 'Ántonio', 'Initials': 'Á', 'LastName': 'Cuesta-Vargas', 'Affiliation': 'Department of Physiotherapy, Faculty of Heath Sciences, University of Malaga, 19071 Málaga, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17207359']
3213,33053849,"Sirolimus Prolongs Survival after Living Donor Liver Transplantation for Hepatocellular Carcinoma Beyond Milan Criteria: A Prospective, Randomised, Open-Label, Multicentre Phase 2 Trial.","Sirolimus (SRL) has been reported to benefit patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC). This study aimed to compare SRL with tacrolimus (TAC) in living-donor LT (LDLT) recipients beyond the Milan criteria. This study was initially designed to enrol 45 recipients who underwent LDLT for HCC beyond the Milan criteria. At 1 month after LT, the patients were randomly assigned to either SRL or TAC-based treatment, with both groups receiving mycophenolate mofetil. The primary outcome was three-year recurrence-free survival (RFS) and the secondary outcome was overall survival (OS). A total of 42 patients completed the study. HCC recurrence occurred in 8 of 22 (36.4%) patients in the SRL group and in 5 of 22 (25%) patients in the TAC group. No differences in RFS and OS were found between the two groups in simple comparison. The type of immunosuppressant remained a nonsignificant factor for recurrence in multivariate analysis; however, SRL significantly prolonged OS (TAC hazard ratio: 15 [1.3-172.85], p = 0.03) after adjusting for alpha-fetoprotein and positron emission tomography standardised uptake value ratio (tumour/background liver). In conclusion, SRL does not decrease HCC recurrence but prolongs OS after LDLT for HCC beyond the Milan criteria.",2020,No differences in RFS and OS were found between the two groups in simple comparison.,"['living-donor LT (LDLT) recipients beyond the Milan criteria', 'patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC', '42 patients completed the study', 'enrol 45 recipients who underwent LDLT for HCC beyond the Milan criteria']","['mycophenolate mofetil', 'SRL or TAC', 'SRL with tacrolimus (TAC', 'Sirolimus (SRL', 'Living Donor Liver Transplantation', 'Sirolimus']","['year recurrence-free survival (RFS', 'RFS and OS', 'HCC recurrence', 'overall survival (OS']","[{'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",42.0,0.0965822,No differences in RFS and OS were found between the two groups in simple comparison.,"[{'ForeName': 'Kwang-Woong', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Seong Hoon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Center for Liver Cancer, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si 410-769, Gyeonggi-do, Korea.'}, {'ForeName': 'Kyung Chul', 'Initials': 'KC', 'LastName': 'Yoon', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Jeong-Moo', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Jae-Hyung', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Suk Kyun', 'Initials': 'SK', 'LastName': 'Hong', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Nam-Joon', 'Initials': 'NJ', 'LastName': 'Yi', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}, {'ForeName': 'Sung-Sik', 'Initials': 'SS', 'LastName': 'Han', 'Affiliation': 'Center for Liver Cancer, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si 410-769, Gyeonggi-do, Korea.'}, {'ForeName': 'Sang-Jae', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Center for Liver Cancer, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si 410-769, Gyeonggi-do, Korea.'}, {'ForeName': 'Kyung-Suk', 'Initials': 'KS', 'LastName': 'Suh', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, 101 Daehak-no, Jongno-gu, Seoul 110-744, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9103264']
3214,33053855,A Clinical Trial to Evaluate the Efficacy and Safety of 3D Printed Bioceramic Implants for the Reconstruction of Zygomatic Bone Defects.,"The purpose of this study was to evaluate the clinical efficacy and safety of patient-specific additive-manufactured CaOSiO 2 -P 2 O 5 -B 2 O 3 glass-ceramic (BGS-7) implants for reconstructing zygomatic bone defects at a 6-month follow-up. A prospective, single-arm, single-center, clinical trial was performed on patients with obvious zygoma defects who needed and wanted reconstruction. The primary outcome variable was a bone fusion between the implant and the bone evaluated by computed tomography (CT) at 6 months post surgery. Secondary outcomes, including implant immobilization, satisfaction assessment, osteolysis, subsidence of the BGS-7 implant, and safety, were assessed. A total of eight patients were enrolled in the study. Two patients underwent simultaneous reconstruction of the left and right malar defects using a BGS-7 3D printed implant. Cone beam CT analysis showed that bone fusion at 6 months after surgery was 100%. We observed that the average fusion rate was 76.97%. Osteolysis around 3D printed BGS-7 implants was not observed. The mean distance displacement of all 10 implants was 0.4149 mm. Our study showed no adverse event in any of the cases. The visual analog scale score for satisfaction was 9. All patients who enrolled in this trial were aesthetically and functionally satisfied with the surgical results. In conclusion, this study demonstrates the safety and promising value of patient-specific 3D printed BGS-7 implants as a novel facial bone reconstruction method.",2020,Osteolysis around 3D printed BGS-7 implants was not observed.,"['A total of eight patients were enrolled in the study', 'patients with obvious zygoma defects who needed and wanted reconstruction']","['BGS-7 3D printed implant', 'O 5 -B 2 O 3 glass-ceramic (BGS-7) implants', 'patient-specific additive-manufactured CaOSiO 2 -P 2', '3D Printed Bioceramic Implants']","['average fusion rate', 'bone fusion between the implant and the bone evaluated by computed tomography (CT', 'implant immobilization, satisfaction assessment, osteolysis, subsidence of the BGS-7 implant, and safety', 'mean distance displacement', 'visual analog scale score for satisfaction', 'clinical efficacy and safety']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043539', 'cui_str': 'Zygomatic bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0265308', 'cui_str': 'Baller-Gerold syndrome'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0045550', 'cui_str': '2,5-dichloro-4-bromophenol'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0442796', 'cui_str': 'Additive'}, {'cui': 'C0608663', 'cui_str': 'P-2'}]","[{'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0185364', 'cui_str': 'Osteoplasty'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4721411', 'cui_str': 'Osteolysis'}, {'cui': 'C0265308', 'cui_str': 'Baller-Gerold syndrome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",8.0,0.0391568,Osteolysis around 3D printed BGS-7 implants was not observed.,"[{'ForeName': 'Ui-Lyong', 'Initials': 'UL', 'LastName': 'Lee', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Chung-Ang University Hospital, Soeul 06973, Korea.'}, {'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Lim', 'Affiliation': 'CGbio 3D Innovation Center, Seongnam-si 13211, Korea.'}, {'ForeName': 'Sung-Nam', 'Initials': 'SN', 'LastName': 'Park', 'Affiliation': 'CGbio 3D Innovation Center, Seongnam-si 13211, Korea.'}, {'ForeName': 'Byoung-Hun', 'Initials': 'BH', 'LastName': 'Choi', 'Affiliation': 'CGbio 3D Innovation Center, Seongnam-si 13211, Korea.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, Seoul 06974, Korea.'}, {'ForeName': 'Won-Cheul', 'Initials': 'WC', 'LastName': 'Choi', 'Affiliation': 'Chung-Ang 3D Craniofacial Research Society, Chun-Ang University, Seoul 06974, Korea.'}]","Materials (Basel, Switzerland)",['10.3390/ma13204515']
3215,33064100,Effect of a Mobile App for the Pharmacotherapeutic Follow-Up of Patients With Cancer on Their Health Outcomes: Quasi-Experimental Study.,"BACKGROUND
Oral antineoplastic agents (OAAs) have revolutionized cancer management. However, they have been reported with adverse side effects and drug-drug interactions. Moreover, patient adherence to OAA treatment is critical. Mobile apps can enable remote and real-time pharmacotherapeutic monitoring of patients, while also promoting patient autonomy in their health care.
OBJECTIVE
The primary objective was to analyze the effect of using a mobile app for the follow-up of patients with oncohematological malignancies undergoing treatment with OAAs on their health outcomes. The secondary objectives were to analyze the role of the app in communication with health care professionals and patient satisfaction with the app.
METHODS
We performed a comparative, quasi-experimental study based on a prepost intervention with 101 patients (control group, n=51, traditional pharmacotherapeutic follow-up vs intervention group, n=50, follow-up through e-OncoSalud, a custom-designed app that promotes follow-up at home and the safety of patients receiving OAAs). The effect of this app on drug safety, adherence to treatment, and quality of life was evaluated.
RESULTS
With regard to drug safety, 73% (37/51) of the patients in the control group and 70% (35/50) of the patients in the intervention group (P=.01) presented with drug-related problems. The probability of detecting an insufficiently treated health problem in the intervention group was significantly higher than that in the control group (P=.04). The proportion of patients who presented with side effects in the intervention group was significantly lower than that in the control group (P>.99). In the control group, 49% (25/51) of the patients consumed some health resources during the first 6 months of treatment compared with 36% (18/50) of the patients in the intervention group (P=.76). Adherence to treatment was 97.6% (SD 7.9) in the intervention group, which was significantly higher than that in the control group (92.9% [SD 10.0]; P=.02). The EuroQol-5D in the intervention group yielded a mean (SD) index of 0.875 (0.156), which was significantly higher than that in the control group (0.741 [0.177]; P<.001). Approximately 60% (29/50) of the patients used the messaging module to communicate with pharmacists. The most frequent types of messages were acknowledgments (77/283, 27.2%), doubts about contraindications and interactions with OAAs (70/283, 24.7%), and consultations for adverse reactions to treatment (39/283, 13.8%). The satisfaction with the app survey conducted in the intervention group yielded an overall mean (SD) score of 9.1 (0.4) out of 10.
CONCLUSIONS
Use of e-OncoSalud for the real-time follow-up of patients receiving OAAs facilitated the optimization of some health outcomes. The intervention group had significantly higher health-related quality of life and adherence to treatment than the control group. Further, the probability of the intervention group presenting with side effects was significantly lower than that of the control group.",2020,The probability of detecting an insufficiently treated health problem in the intervention group was significantly higher than that in the control group (P=.04).,"['101 patients (control group, n=51', 'Patients With Cancer on Their Health Outcomes', 'patients with oncohematological malignancies undergoing treatment with OAAs on their health outcomes']","['Mobile App', 'traditional pharmacotherapeutic follow-up vs intervention group, n=50, follow-up through e-OncoSalud, a custom-designed app that promotes follow-up at home and the safety of patients receiving OAAs']","['overall mean (SD) score', 'drug safety, adherence to treatment, and quality of life', 'mean (SD) index', 'side effects', 'health resources', 'higher health-related quality of life and adherence', 'probability of detecting an insufficiently treated health problem']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",,0.0447273,The probability of detecting an insufficiently treated health problem in the intervention group was significantly higher than that in the control group (P=.04).,"[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Collado-Borrell', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Escudero-Vilaplana', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Almudena', 'Initials': 'A', 'LastName': 'Ribed', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gonzalez-Anleo', 'Affiliation': 'Hospital Clinic Barcelona, Barcelona, Spain.'}, {'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'Martin-Conde', 'Affiliation': 'Hospital Clinic Barcelona, Barcelona, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Romero-Jimenez', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Iglesias-Peinado', 'Affiliation': 'Faculty of Pharmacy, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Herranz-Alonso', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sanjurjo-Saez', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}]",JMIR mHealth and uHealth,['10.2196/20480']
3216,33064101,High-Intensity Interval Aerobic Resistance Training to Counteract Low Relative Appendicular Lean Soft Tissue Mass in Middle Age: Study Protocol for a Randomized Controlled Trial.,"BACKGROUND
Sarcopenia is the age-related loss of skeletal muscle mass and function and may exist in early middle age. Previous research in this area has focused on resistance training in older individuals; however, there is a lack of intervention trials in middle-aged adults with low relative appendicular lean soft tissue mass who may be at risk for sarcopenia in older age.
OBJECTIVE
This randomized controlled trial aims to determine the effects of a high-intensity interval aerobic resistance training intervention on appendicular lean soft tissue mass in middle-aged adults with low relative appendicular lean soft tissue mass.
METHODS
We will conduct a 40-week, single-blinded randomized controlled trial in 84 middle-aged adults with low appendicular lean soft tissue mass in the wider Dunedin area, New Zealand. We will randomly allocate participants to receive either a group-based, 20-week high-intensity interval aerobic resistance training intervention program or a single, 60-minute education session on current exercise recommendations. After the first 20 weeks, both groups will be given a 20-week home program. The study will assess primary and secondary outcome measures, including body composition (regional and whole-body lean soft tissue mass, fat mass, percentage body fat, measured by dual x-ray absorptiometry), blood biomarkers (cortisol, creatinine, C-reactive protein, lipid profile, hemoglobin), physical fitness (maximum oxygen consumption, blood pressure), physical activity (accelerometry), physical function (handgrip strength, sit-to-stand, gait speed, quadriceps strength), and self-reported questionnaires (health outcomes, self-efficacy, perceived enjoyment of physical activity, and multifactorial lifestyle), at baseline, 20 weeks, and 40 weeks. Physical function and self-reported questionnaires will also be measured at 10 weeks. We will assess the primary outcome measure, total body lean soft tissue mass, at baseline, 20 weeks, and 40 weeks. Analyses will be performed using intention-to-treat principles, comparing the outcomes resulting from the intervention, using linear mixed models.
RESULTS
We obtained ethical approval for this study from The University of Otago Human Ethics Committee on December 10, 2018. Participant recruitment started on February 11, 2019 and was completed on May 14, 2019. Data collection started on February 25, 2019 and was completed on February 28, 2020. We expect to publish the results in January 2021.
CONCLUSIONS
High-intensity interval aerobic resistance training is a time-efficient form of exercise, enabling busy middle-aged adults to meet physical activity recommendations while maximizing training results. The findings can inform the development of future prevention-focused interventions aimed at counteracting the high prevalence of sarcopenia in the aging population.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry (ACTRN12618001778279); https://tinyurl.com/y555z6fz.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/22989.",2020,"We will assess the primary outcome measure, total body lean soft tissue mass, at baseline, 20 weeks, and 40 weeks.","['middle-aged adults with low relative appendicular lean soft tissue mass', 'older individuals', 'Middle Age', '84 middle-aged adults with low appendicular lean soft tissue mass in the wider Dunedin area, New Zealand', 'middle-aged adults with low relative appendicular lean soft tissue mass who may be at risk for sarcopenia in older age', 'busy middle-aged adults']","['high-intensity interval aerobic resistance training intervention', 'High-Intensity Interval Aerobic Resistance Training', '20-week high-intensity interval aerobic resistance training intervention program or a single, 60-minute education session on current exercise recommendations', 'https://tinyurl.com/y555z6fz', 'High-intensity interval aerobic resistance training']","['total body lean soft tissue mass', 'body composition (regional and whole-body lean soft tissue mass, fat mass, percentage body fat, measured by dual x-ray absorptiometry), blood biomarkers (cortisol, creatinine, C-reactive protein, lipid profile, hemoglobin), physical fitness (maximum oxygen consumption, blood pressure), physical activity (accelerometry), physical function (handgrip strength, sit-to-stand, gait speed, quadriceps strength), and self-reported questionnaires (health outcomes, self-efficacy, perceived enjoyment of physical activity, and multifactorial lifestyle', 'appendicular lean soft tissue mass']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0457193', 'cui_str': 'Soft tissue mass'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0231337', 'cui_str': 'Senility'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0457193', 'cui_str': 'Soft tissue mass'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]",84.0,0.169898,"We will assess the primary outcome measure, total body lean soft tissue mass, at baseline, 20 weeks, and 40 weeks.","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Vlietstra', 'Affiliation': 'Department of Medicine, Otago Medical School, Dunedin Campus, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Waters', 'Affiliation': 'Department of Medicine, Otago Medical School, Dunedin Campus, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Lynnette M', 'Initials': 'LM', 'LastName': 'Jones', 'Affiliation': 'School of Physical Education, Sport & Exercise Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Meredith-Jones', 'Affiliation': 'Department of Medicine, Otago Medical School, Dunedin Campus, University of Otago, Dunedin, New Zealand.'}]",JMIR research protocols,['10.2196/22989']
3217,33055441,"Safety and Efficacy of Oral Intake of Ceramide-Containing Acetic Acid Bacteria for Improving the Stratum Corneum Hydration: A Randomized, Double-Blind, Placebo-Controlled Study over 12 Weeks.","The barrier function of the skin protects it from external stresses to which it is constantly exposed, such as dryness, ultraviolet rays, and chemicals. Lipids, in particular a type of sphingolipid known as ceramides, play a central role in the barrier function of the skin by preventing dryness. The number of ceramides in the skin is known to decrease with age, which has led to the development of a large number of anti-aging cosmetic products that contain ceramides. Recently, it has become evident that oral intake of ceramides can also improve the quality of the skin. To elucidate the effects of oral ceramide intake on skin moisture content, we conducted a randomized, double-blinded, placebo-controlled parallel comparative study in which males and females between 20 and 60 years of age who were worried about dry skin ingested a food with acetic acid bacteria containing 0.8 mg of dihydroceramide or a placebo for 12 weeks. Concurrently, we investigated the safety of continuous ingestion of the ceramide-containing food over 12 weeks. Oral intake of ceramide over the 12 weeks significantly improved stratum corneum hydration, i.e. the moisture content of the skin, and did not result in harmful effects in any of the participants.",2020,"Oral intake of ceramide over the 12 weeks significantly improved stratum corneum hydration, i.e. the moisture content of the skin, and did not result in harmful effects in any of the participants.","['for 12 weeks', 'males and females between 20 and 60 years of age who were worried about dry skin ingested a food with']","['Ceramide-Containing Acetic Acid Bacteria', 'oral ceramide intake', 'placebo', 'acetic acid bacteria containing 0.8 mg of dihydroceramide or a placebo', 'Placebo']","['Stratum Corneum Hydration', 'stratum corneum hydration']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0668446', 'cui_str': 'dihydroceramide'}]","[{'cui': 'C0221921', 'cui_str': 'Stratum corneum structure'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}]",,0.166454,"Oral intake of ceramide over the 12 weeks significantly improved stratum corneum hydration, i.e. the moisture content of the skin, and did not result in harmful effects in any of the participants.","[{'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Tsuchiya', 'Affiliation': 'Central Research Institute, Mizkan Holdings Co., Ltd.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Ban', 'Affiliation': 'Central Research Institute, Mizkan Holdings Co., Ltd.'}, {'ForeName': 'Mikiya', 'Initials': 'M', 'LastName': 'Kishi', 'Affiliation': 'Central Research Institute, Mizkan Holdings Co., Ltd.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Ono', 'Affiliation': 'Ueno-Asagao Clinic.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Masaki', 'Affiliation': 'School of Bioscience and Biotechnology, Tokyo University of Technology.'}]",Journal of oleo science,['10.5650/jos.ess20115']
3218,33060258,Aerosolized Calfactant for Newborns With Respiratory Distress: A Randomized Trial.,"BACKGROUND
Exogenous surfactants to treat respiratory distress syndrome (RDS) are approved for tracheal instillation only; this requires intubation, often followed by positive pressure ventilation to promote distribution. Aerosol delivery offers a safer alternative, but clinical studies have had mixed results. We hypothesized that efficient aerosolization of a surfactant with low viscosity, early in the course of RDS, could reduce the need for intubation and instillation of liquid surfactant.
METHODS
A prospective, multicenter, randomized, unblinded comparison trial of aerosolized calfactant (Infasurf) in newborns with signs of RDS that required noninvasive respiratory support. Calfactant was aerosolized by using a Solarys nebulizer modified with a pacifier adapter; 6 mL/kg (210 mg phospholipid/kg body weight) were delivered directly into the mouth. Infants in the aerosol group received up to 3 treatments, at least 4 hours apart. Infants in the control group received usual care, determined by providers. Infants were intubated and given instilled surfactant for persistent or worsening respiratory distress, at their providers' discretion.
RESULTS
Among 22 NICUs, 457 infants were enrolled; gestation 23 to 41 (median 33) weeks and birth weight 595 to 4802 (median 1960) grams. In total, 230 infants were randomly assigned to aerosol; 225 received 334 treatments, starting at a median of 5 hours. The rates of intubation for surfactant instillation were 26% in the aerosol group and 50% in the usual care group ( P < .0001). Respiratory outcomes up to 28 days of age were no different.
CONCLUSIONS
In newborns with early, mild to moderate respiratory distress, aerosolized calfactant at a dose of 210 mg phospholipid/kg body weight reduced intubation and surfactant instillation by nearly one-half.",2020,The rates of intubation for surfactant instillation were 26% in the aerosol group and 50% in the usual care group ( P < .0001).,"['Newborns With Respiratory Distress', '230 infants', 'Among 22 NICUs, 457 infants were enrolled; gestation 23 to 41 (median 33) weeks and birth weight 595 to 4802 (median 1960) grams', 'newborns with signs of RDS that required noninvasive respiratory support']","['Aerosolized Calfactant', 'aerosolized calfactant (Infasurf', 'instilled surfactant']",['rates of intubation for surfactant instillation'],"[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C5191367', 'cui_str': '595'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0763530', 'cui_str': 'calfactant'}, {'cui': 'C0763529', 'cui_str': 'Infasurf'}, {'cui': 'C1720298', 'cui_str': 'Instill'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}]",230.0,0.161211,The rates of intubation for surfactant instillation were 26% in the aerosol group and 50% in the usual care group ( P < .0001).,"[{'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Cummings', 'Affiliation': 'Albany Medical Center, Albany, New York; cummings.AMBI@gmail.com.'}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Gerday', 'Affiliation': 'Utah Valley Regional Medical Center, Provo, Utah.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Minton', 'Affiliation': 'Utah Valley Regional Medical Center, Provo, Utah.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Katheria', 'Affiliation': 'Sharp Mary Birch Hospital for Women and Newborns, San Diego, California.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Albert', 'Affiliation': 'Sisters of Charity Hospital, Buffalo, New York.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Flores-Torres', 'Affiliation': 'Tampa General Hospital, Tampa, Florida.'}, {'ForeName': 'Mobolaji', 'Initials': 'M', 'LastName': 'Famuyide', 'Affiliation': 'Department of Pediatrics, University of Mississippi, Oxford, Mississippi.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lampland', 'Affiliation': ""Children's Minnesota St. Paul Hospital, St. Paul, Minnesota.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Jackson-Madison County General Hospital, Jackson, Tennessee.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Kuehn', 'Affiliation': 'East Carolina University and Vidant Medical Center, Greenville, North Carolina.'}, {'ForeName': 'Jörn-Hendrik', 'Initials': 'JH', 'LastName': 'Weitkamp', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Fort', 'Affiliation': ""Johns Hopkins All Children's Hospital, St. Petersburg, Florida.""}, {'ForeName': 'Elie G', 'Initials': 'EG', 'LastName': 'Abu Jawdeh', 'Affiliation': ""University of Kentucky Children's Hospital, Lexington, Kentucky.""}, {'ForeName': 'Rita M', 'Initials': 'RM', 'LastName': 'Ryan', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Gregory C', 'Initials': 'GC', 'LastName': 'Martin', 'Affiliation': ""Phoenix Children's Hospital, Phoenix, Arizona.""}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Swanson', 'Affiliation': ""University of Virginia Children's Hospital, Charlottesville, Virginia.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Mulrooney', 'Affiliation': ""Children's Minneapolis Hospital, Minneapolis, Minnesota.""}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Eyal', 'Affiliation': ""University of South Alabama Children's and Women's Hospital, Mobile, Alabama.""}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Gerstmann', 'Affiliation': 'Timpanogos Regional Hospital, Orem, Utah.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': ""Order of St. Francis Children's Hospital of Illinois, Peoria, Illinois.""}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Wilding', 'Affiliation': 'Department of Biostatistics, University at Buffalo, Buffalo, New York; and.'}, {'ForeName': 'Edmund A', 'Initials': 'EA', 'LastName': 'Egan', 'Affiliation': 'ONY Biotech, Amherst, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatrics,['10.1542/peds.2019-3967']
3219,33060370,Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis.,"BACKGROUND
Psoriasis is a chronic inflammatory skin disease, affecting about 0.6% of the Chinese population. Many patients are not well controlled by conventional treatments, thus there is need for new treatment regimens. In this study, we assessed the efficacy and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis.
METHODS
This study was a 52-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial. A sub-population of study participants (≥18 years) of Chinese ethnicity were randomized to receive subcutaneous injections of 300 or 150 mg secukinumab, or placebo. The co-primary endpoints were psoriasis area severity index (PASI) 75 and Investigator's Global Assessment (IGA) 0/1 at Week 12.
RESULTS
A total of 441 Chinese patients were enrolled in this study. Co-primary outcomes were achieved; 300 and 150 mg secukinumab were superior to placebo as shown in the proportion of patients that achieved PASI 75 (97.7% and 87.2% vs. 3.7%, respectively; P < 0.001), and IGA 0/1 (82.3% and 69.7% vs. 2.7%; P < 0.001) at Week 12. Treatment efficacy was maintained until Week 52. There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.
CONCLUSION
Secukinumab is highly effective and well tolerated in Chinese patients with moderate to severe plaque psoriasis.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03066609; https://clinicaltrials.gov/ct2/show/record/NCT03066609.",2020,"There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.
","['A sub-population of study participants (≥18 years) of Chinese ethnicity', '441 Chinese patients', 'Chinese patients with moderate to severe plaque psoriasis']","['Secukinumab', 'placebo', 'secukinumab', 'subcutaneous injections of 300 or 150 mg secukinumab, or placebo']","['efficacy and safety', 'psoriasis area severity index (PASI', 'overall adverse events', 'Treatment efficacy']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",441.0,0.59253,"There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.
","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': ""Department of Dermatology, Peking University People's Hospital, Beijing 100044, China.""}, {'ForeName': 'Jian-Zhong', 'Initials': 'JZ', 'LastName': 'Zhang', 'Affiliation': ""Department of Dermatology, Peking University People's Hospital, Beijing 100044, China.""}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': 'Institute of Dermatology, Chinese Academy of Medical Science & Peking Union Medical College, Beijing 100730, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Dermatology, Changhai Hospital, Shanghai 200433, China.'}, {'ForeName': 'Quan-Zhong', 'Initials': 'QZ', 'LastName': 'Liu', 'Affiliation': 'Department of Dermatology, Tianjin Medical University General Hospital, Tianjin 300052, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Department of Dermatology, Second Affiliated Hospital School of Medicine, Zhejiang University, Hangzhou, Zhejiang 311215, China.'}, {'ForeName': 'Shi-Fa', 'Initials': 'SF', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, General Hospital of Northern Theater Command, Shenyang, Liaoning 110016, China.'}, {'ForeName': 'Jin-Hua', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Cheng-Xin', 'Initials': 'CX', 'LastName': 'Li', 'Affiliation': ""Department of Dermatology and Venereology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Dermatology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310016, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Dermatology, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong 510120, China.'}, {'ForeName': 'Wei-Li', 'Initials': 'WL', 'LastName': 'Pan', 'Affiliation': ""Department of Dermatology, Zhejiang Provincial People's Hospital, Zhejiang, Hangzhou, Zhejiang 310014, China.""}, {'ForeName': 'Shen-Qiu', 'Initials': 'SQ', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Ruo-Yu', 'Initials': 'RY', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Peking University First Hospital, Beijing 100034, China.'}, {'ForeName': 'Zai-Pei', 'Initials': 'ZP', 'LastName': 'Guo', 'Affiliation': 'Department of Dermatology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.'}, {'ForeName': 'Zhi-Qi', 'Initials': 'ZQ', 'LastName': 'Song', 'Affiliation': 'Department of Dermatology, First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China.'}, {'ForeName': 'Shan-Shan', 'Initials': 'SS', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, The First Hospital of Jilin University, Changchun, Jilin 130021, China.'}, {'ForeName': 'Xiu-Qin', 'Initials': 'XQ', 'LastName': 'Dong', 'Affiliation': 'Department of Dermatology, Guangdong General Hospital, Guangzhou, Guangdong 510080, China.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Beijing Novartis Pharma Co. Ltd., Shanghai 201203, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Fu', 'Affiliation': 'Beijing Novartis Pharma Co. Ltd., Shanghai 201203, China.'}, {'ForeName': 'Pascaline', 'Initials': 'P', 'LastName': 'Regnault', 'Affiliation': 'Novartis Pharma AG, Basel 6463, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Charef', 'Affiliation': 'Novartis Pharma AG, Basel 6463, Switzerland.'}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Mazur', 'Affiliation': 'Novartis Pharma AG, Basel 6463, Switzerland.'}, {'ForeName': 'Manmath', 'Initials': 'M', 'LastName': 'Patekar', 'Affiliation': 'Novartis Pharma AG, Basel 6463, Switzerland.'}]",Chinese medical journal,['10.1097/CM9.0000000000001163']
3220,33057967,Quality-of-Life Comparison of Dapagliflozin Versus Dipeptidyl Peptidase 4 Inhibitors in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial (J-BOND Study).,"INTRODUCTION
No study has compared the effects of sodium-glucose cotransporter 2 inhibitors (SGLT2is) and dipeptidyl peptidase 4 inhibitors (DPP4is) on patients' quality-of-life (QOL).
METHODS
We enrolled 253 drug-naïve Japanese patients with type 2 diabetes mellitus (T2DM), randomly assigned them into a dapagliflozin (SGLT2i) group or DPP4i group in approximately 1:1 ratio, and monitored them for 24 weeks. The primary endpoint was the proportion of subjects indicating improvement in the ""overall quality of life"" domain of SHIELD-WQ-9 at week 24. Secondary endpoints included other domains of SHIELD-WQ-9, DTR-QOL, EQ-5D-5L, medication preference, medication adherence, diet therapy adherence, body weight, body mass index (BMI), abdominal circumference, HbA1c, and frequency of adverse events.
RESULTS
The proportion of subjects indicating improvement in the ""overall quality of life"" domain of SHIELD-WQ-9 at week 24 was higher in the dapagliflozin group (28.4%) than in the DPP4i group (18.6%) (p = 0.08). The proportion of subjects indicating improvement in the ""physical health"" domain of SHIELD-WQ-9 at week 24 was significantly higher in the dapagliflozin group (42.2%) than in the DPP4i group (23.7%) (p = 0.004). Total scores and domain 1 scores of DTR-QOL showed greater improvement in the dapagliflozin group (14.3 ± 15.6 and 15.5 ± 20.8, respectively) than in the DPP4i group (10.2 ± 15.6 and 10.3 ± 19.5, respectively) (both p = 0.05). EQ-5D-5L scores had significantly improved in the DPP4i group (0.023 ± 0.088) (p = 0.005); the intergroup difference was not significant (p = 0.14). Body weight (p < 0.001), BMI (p < 0.001), and abdominal circumference (p = 0.019) had significantly decreased in the dapagliflozin group compared with the corresponding values in the DPP4i group.
CONCLUSION
Dapagliflozin showed a comparable or more favorable benefit on Japanese patients' QOL compared with DPP4is. Dapagliflozin was well tolerated. It significantly reduced body weight, which was significantly correlated with improvement in the patients' QOL. This study demonstrates that dapagliflozin can be used as a first-line drug for T2DM in Japan with a beneficial impact on patients' QOL.
TRIAL REGISTRATION
University Hospital Medical Information Network Clinical Trial Registry (UMIN000030514); Japan Registry of Clinical Trials (jRCTs051180165).",2020,"Total scores and domain 1 scores of DTR-QOL showed greater improvement in the dapagliflozin group (14.3 ± 15.6 and 15.5 ± 20.8, respectively) than in the DPP4i group (10.2 ± 15.6 and 10.3 ± 19.5, respectively) (both p = 0.05).","['patients', 'Patients with Type\xa02 Diabetes Mellitus', '253 drug-naïve Japanese patients with type\xa02 diabetes mellitus (T2DM']","['dapagliflozin (SGLT2i) group or DPP4i', 'Dapagliflozin Versus Dipeptidyl Peptidase', 'sodium-glucose cotransporter\xa02 inhibitors (SGLT2is) and dipeptidyl peptidase\xa04 inhibitors (DPP4is', 'Dapagliflozin', 'dapagliflozin']","['BMI', 'overall quality of life"" domain of SHIELD-WQ-9', 'abdominal circumference', 'domains of SHIELD-WQ-9, DTR-QOL, EQ-5D-5L, medication preference, medication adherence, diet therapy adherence, body weight, body mass index (BMI), abdominal circumference, HbA1c, and frequency of adverse events', ""Japanese patients' QOL"", 'Total scores and domain\xa01 scores of DTR-QOL', 'physical health"" domain of SHIELD-WQ-9', 'EQ-5D-5L scores', 'body weight', 'tolerated', 'quality-of-life (QOL', 'proportion of subjects indicating improvement in the ""overall quality of life"" domain of SHIELD-WQ-9', 'Body weight']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012515', 'cui_str': 'Dipeptidylpeptide hydrolase'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C3884528', 'cui_str': 'HBEGF protein, human'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}]",253.0,0.039766,"Total scores and domain 1 scores of DTR-QOL showed greater improvement in the dapagliflozin group (14.3 ± 15.6 and 15.5 ± 20.8, respectively) than in the DPP4i group (10.2 ± 15.6 and 10.3 ± 19.5, respectively) (both p = 0.05).","[{'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ishii', 'Affiliation': 'Department of Doctor-Patient Relationships, Nara Medical University, Kashihara, Nara, Japan. hit3910@gmail.com.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Nakajima', 'Affiliation': 'Department of Diabetes and Endocrinology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Kamei', 'Affiliation': 'Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital, Hiroshima, Hiroshima, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Niiya', 'Affiliation': 'Matsuyama Shimin Hospital, Matsuyama, Ehime, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Hiyoshi', 'Affiliation': 'Division of Diabetes and Endocrinology, Japanese Red Cross Medical Center, Shibuya-ku, Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Hiramori', 'Affiliation': 'Suzuran-Naika Clinic of Medicine, Nara, Nara, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Ohtsu', 'Affiliation': 'Nakanoshima Diabetes Clinic, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Noto', 'Affiliation': 'Nishiyamato Diabetes Clinic, Kita-Katsuragi-gun, Nara, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Shimono', 'Affiliation': 'Futata Tetsuhiro Clinic, Fukuoka, Fukuoka, Japan.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00941-8']
3221,33058901,Virtual and real-life ostracism and its impact on a subsequent acute stressor.,"While ostracism constitutes a social stressor with negative effects on physical and mental health, social inclusion seems to increase resilience. This may be true not only for face-to-face settings, but also for computer-mediated interactions. Hence, this study examined the differences between ostracism and social inclusion in real-life or Virtual Reality (VR) regarding self-reported stress, neuroendocrine and cardiovascular reactivity in a subsequent real-life socio-evaluative task. 84 females were randomly assigned to a 3 (agency: face-to-face/human controlled VR-avatar/computer VR-agent) x 2 (inclusion status: inclusion/exclusion) between-subject design using a Cyberball paradigm. Subsequently, they were exposed to a real-life Trier Social Stress Test (TSST). Results indicate that the experience of ostracism constitutes a threat to fundamental social needs independent of agency. Excluded participants showed cardiovascular reactivity during TSST; also face-to-face and avatar excluded individuals had elevated salivary cortisol levels. Included participants reported more perceived social support during Cyberball and showed a blunted cortisol response to the TSST. These results suggest that face-to-face and avatar-related ostracism provokes responses in the hypothalamic-pituitary-adrenal (HPA) axis and the sympathetic nervous system (SNS). Furthermore, they reveal that social inclusion may act as a stress-protector as it alters HPA- and SNS-related stress responsiveness to subsequent stressors.",2020,Excluded participants showed cardiovascular reactivity during TSST; also face-to-face and avatar excluded individuals had elevated salivary cortisol levels.,['84 females'],['3 (agency: face-to-face/human controlled VR-avatar/computer VR-agent) x 2 (inclusion status: inclusion/exclusion) between-subject design using a Cyberball paradigm'],"['cardiovascular reactivity', 'elevated salivary cortisol levels', 'perceived social support', 'blunted cortisol response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",84.0,0.0106574,Excluded participants showed cardiovascular reactivity during TSST; also face-to-face and avatar excluded individuals had elevated salivary cortisol levels.,"[{'ForeName': 'Oswald D', 'Initials': 'OD', 'LastName': 'Kothgassner', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria; Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goreis', 'Affiliation': 'Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria; Outpatient Unit for Research, Teaching and Practice, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Glenk', 'Affiliation': 'Department of Comparative Medicine, Messerli Research Institute, University of Veterinary Medicine Vienna, Medical University Vienna and University, Vienna, Austria.'}, {'ForeName': 'Johanna Xenia', 'Initials': 'JX', 'LastName': 'Kafka', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Beutl', 'Affiliation': 'Working Group Entertainment Computing, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Kryspin-Exner', 'Affiliation': 'Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hlavacs', 'Affiliation': 'Working Group Entertainment Computing, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Palme', 'Affiliation': 'Department of Biomedical Sciences, University of Veterinary Medicine, Vienna, Austria.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Felnhofer', 'Affiliation': 'Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria; Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: anna.felnhofer@meduniwien.ac.at.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113205']
3222,33058957,"Nutritional adequacy of very low- and high-carbohydrate, low saturated fat diets in adults with type 2 diabetes: A secondary analysis of a 2-year randomised controlled trial.","BACKGROUND
Growing evidence supports use of very low-carbohydrate (LC) diets for glycaemic control in type 2 diabetes. However, limited data on the micronutrient adequacy of LC diets exist.
OBJECTIVE
This study compared the long-term effects of a very low-carbohydrate, high unsaturated/low saturated fat (LC) diet to a high-carbohydrate, low-fat (HC) diet on micronutrient biomarkers in adults with obesity and type 2 diabetes.
METHODS
115 adults with type 2 diabetes (mean[SD]; BMI:34.6[4.3]kg/m 2 , age:58[7]yrs, HbA1c:7.3[1.1]%, 56[12]mmol/mol) were randomized to one of two planned, nutritionally-replete, energy-matched, hypocaloric diets (500-1000 kcal/day deficit): (1) LC:14% energy carbohydrate, 28%protein, 58%fat[<10% saturated fat]) or (2) HC:53%carbohydrate, 17%protein, 30%fat [<10%saturated fat]) for 2 years. Nutritional biomarkers- folate, β-carotene, vitamin B12, D, E, copper, zinc, selenium, calcium, magnesium, sodium, potassium, iron, ferritin, transferrin and transferrin saturation were measured in fasting blood at baseline, 24, 52 and 104 weeks.
RESULTS
61 participants completed the study with similar dropouts in each group (P = 0.40). For all biomarkers assessed, there were no differential response between groups overtime (P ≥ 0.17 time × diet interaction). Mean vitamin and mineral levels remained within normal (laboratory-specific) reference ranges without any reported cases of clinical deficiencies.
CONCLUSION
In free-living individuals with type 2 diabetes, nutrition biomarkers within normal ranges at baseline did not change significantly after 2 years on a prescribed LC or HC diet. These results demonstrate the feasibility of delivering a nutritionally replete LC diet and the importance of considering nutritional factors in planning LC diets that have strong public health relevance to the dietary management of type 2 diabetes.
TRIAL REGISTRATION
http://www.anzctr.org.au/, ANZCTR No. ACTRN12612000369820.",2020,"For all biomarkers assessed, there were no differential response between groups overtime (P≥0.17 time x diet interaction).","['115 adults with type 2 diabetes (mean[SD', 'type 2 diabetes', 'adults with obesity and type 2 diabetes', 'adults with type 2 diabetes', '61 participants completed the study with similar dropouts in each group (P=0.40']","['very low-carbohydrate, high unsaturated/low saturated fat (LC) diet to a high-carbohydrate, low-fat (HC) diet', 'nutritionally-replete, energy-matched, hypocaloric diets (500-1000kcal/day deficit): (1) LC:14% energy carbohydrate, 28%protein, 58%fat[<10% saturated fat]) or (2) HC:53%carbohydrate, 17%protein, 30%fat [<10%saturated fat', 'low-carbohydrate (LC) diets', 'very low- and high-carbohydrate, low saturated fat diets']","['Nutritional biomarkers- folate, β-carotene, vitamin B12, D, E, copper, zinc, selenium, calcium, magnesium, sodium, potassium, iron, ferritin, transferrin and transferrin saturation', 'Mean vitamin and mineral levels']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0522535', 'cui_str': 'Unsaturated'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0007269', 'cui_str': 'Carotene'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",115.0,0.0668126,"For all biomarkers assessed, there were no differential response between groups overtime (P≥0.17 time x diet interaction).","[{'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Tay', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation (CSIRO) - Health and Biosecurity, Adelaide, Australia; Discipline of Medicine, University of Adelaide, Adelaide, Australia; Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR), Singapore. Electronic address: jeannie_tay@sics.a-star.edu.sg.'}, {'ForeName': 'Campbell H', 'Initials': 'CH', 'LastName': 'Thompson', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Luscombe-Marsh', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation (CSIRO) - Health and Biosecurity, Adelaide, Australia.'}, {'ForeName': 'Manny', 'Initials': 'M', 'LastName': 'Noakes', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation (CSIRO) - Health and Biosecurity, Adelaide, Australia.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Buckley', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Wittert', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Brinkworth', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation (CSIRO) - Health and Biosecurity, Sydney, Australia.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108501']
3223,33049455,The effectiveness of brief animated films as a scalable micro-intervention to improve children's body image: A randomised controlled trial.,"Creating media to counteract the plethora of media and advertising that perpetuates negative body image is a scalable public health strategy that can be achieved through innovative micro-interventions. This study examined the immediate and short-term (one-week follow-up) impact of viewing brief, evidence-informed animated films on young people's body image, media literacy, and self-efficacy in addressing appearance teasing. The animations were co-created through a partnership among academics, a personal care brand's social mission, and a children's television channel. Participants aged 7-14 (N = 1329, 49 % girls) were randomised into one of three viewing conditions: Appearance Teasing & Bullying, Media & Celebrities, or a non-appearance-related animation. Contrary to predictions, all three animations were comparably effective at eliciting intervention effects. For girls and boys aged 7-10, all three animations immediately improved state body satisfaction (+boys aged 11-14; Cohen's ds = .60-.71) and led to sustained improvements in trait media literacy (+girls aged 11-14; ds = .38-.61), sensitivity to appearance teasing (+boys aged 11-14; ds = .35-.48), and willingness to ignore appearance teasing (7-10 years only; ds = .34-.74) at one-week follow-up. Findings indicate that children's media is an effective medium for developing micro-interventions.",2020,"For girls and boys aged 7-10, all three animations immediately improved state body satisfaction (+boys aged 11-14; Cohen's ds = .60-.71) and led to sustained improvements in trait media literacy (+girls aged 11-14; ds = .38-.61), sensitivity to appearance teasing (+boys aged 11-14; ds = .35-.48), and willingness to ignore appearance teasing (7-10 years only; ds = .34-.74) at one-week follow-up.","['Participants aged 7-14 (N = 1329, 49 % girls', ""children's body image""]","['viewing brief, evidence-informed animated films']","['state body satisfaction', 'trait media literacy', 'sensitivity to appearance teasing']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C1704608', 'cui_str': 'Film'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C4721445', 'cui_str': 'Teasing'}]",,0.0220831,"For girls and boys aged 7-10, all three animations immediately improved state body satisfaction (+boys aged 11-14; Cohen's ds = .60-.71) and led to sustained improvements in trait media literacy (+girls aged 11-14; ds = .38-.61), sensitivity to appearance teasing (+boys aged 11-14; ds = .35-.48), and willingness to ignore appearance teasing (7-10 years only; ds = .34-.74) at one-week follow-up.","[{'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Matheson', 'Affiliation': 'Centre for Appearance Research, Department of Health and Social Sciences, University of the West of England, Coldharbour Lane, Bristol, BS16 1QY, UK. Electronic address: emily.matheson@uwe.ac.uk.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Lewis-Smith', 'Affiliation': 'Centre for Appearance Research, Department of Health and Social Sciences, University of the West of England, Coldharbour Lane, Bristol, BS16 1QY, UK.'}, {'ForeName': 'Phillippa C', 'Initials': 'PC', 'LastName': 'Diedrichs', 'Affiliation': 'Centre for Appearance Research, Department of Health and Social Sciences, University of the West of England, Coldharbour Lane, Bristol, BS16 1QY, UK.'}]",Body image,['10.1016/j.bodyim.2020.08.015']
3224,33050459,May Mangafodipir or Other SOD Mimetics Contribute to Better Care in COVID-19 Patients?,"Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is characterized by massive inflammation of the arterial endothelium accompanied by vasoconstriction and widespread pulmonary micro thrombi. As a result, due to the destruction of nitric oxide ( • NO) by inflammatory superoxide (O 2 •- ), pulmonary • NO concentration ceases, resulting in uncontrolled platelet aggregation and massive thrombosis, which kills the patients. Introducing • NO by inhalation (INO) may replace the loss of endothelium-derived • NO. The first results from clinical trials with INO in SARS-CoV-2 patients show a rapid and sustained improvement in cardiopulmonary function and decreased inflammation. An ongoing phase III study is expected to confirm the method's efficacy. INO may hence become a first line treatment in SARS-CoV-2 patients. However, due to the rapid inactivation of • NO by deoxyhemoglobin to nitrate, pulmonary administration of • NO will not protect remote organs. Another INO-related pharmacological approach to protect SARS-CoV-2 patients from developing life-threatening disease is to inhibit the O 2 •- -driven destruction of • NO by neutralizing inflammatory O 2 •- . By making use of low molecular weight compounds that mimic the action of the enzyme manganese superoxide dismutase (MnSOD). The MnSOD mimetics of the so-called porphyrin type (e.g., AEOL 10150), salen type (e.g., EUK-8) and cyclic polyamine type (e.g., M40419, today known as GC4419 and avasopasem manganese) have all been shown to positively affect the inflammatory response in lung epithelial cells in preclinical models of chronic obstructive pulmonary disease. The Manganese diPyridoxyL EthylDiamine (MnPLED)-type mangafodipir (manganese dipyridoxyl diphosphate-MnDPDP), a magnetic resonance imaging (MRI) contrast agent that possesses MnSOD mimetic activity, has shown promising results in various forms of inflammation, in preclinical as well as clinical settings. Intravenously administration of mangafodipir will, in contrast to INO, reach remote organs and may hence become an important supplement to INO. From the authors' viewpoint, it appears logical to test mangafodipr in COVID-19 patients at risk of developing life-threatening SARS-CoV-2. Five days after submission of the current manuscript, Galera Pharmaceuticals Inc. announced the dosing of the first patient in a randomized, double-blind pilot phase II clinical trial with GC4419 for COVID-19. The study was first posted on ClinicalTrials.gov (Identifier: NCT04555096) 18 September 2020.",2020,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is characterized by massive inflammation of the arterial endothelium accompanied by vasoconstriction and widespread pulmonary micro thrombi.,['SARS-CoV-2 patients'],"['mangafodipir', 'magnetic resonance imaging (MRI']",['cardiopulmonary function and decreased inflammation'],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0772321', 'cui_str': 'MANGAFODIPIR'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.0324482,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is characterized by massive inflammation of the arterial endothelium accompanied by vasoconstriction and widespread pulmonary micro thrombi.,"[{'ForeName': 'Jan Olof G', 'Initials': 'JOG', 'LastName': 'Karlsson', 'Affiliation': 'Division of Drug Research/Pharmacology, Linköping University, SE-581 83 Linköping, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Jynge', 'Affiliation': 'Innlandet Trust Hospital, Gjøvik Hospital, NO-2819 Gjøvik, Norway.'}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Ignarro', 'Affiliation': 'Department of Pharmacology, UCLA School of Medicine, 264 El Camino Drive, Beverly Hills, CA 90212, USA.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9100971']
3225,33050586,"The Effect of Fermented Porcine Placental Extract on Fatigue-Related Parameters in Healthy Adults: A Double-Blind, Randomized, Placebo-Controlled Trial.","BACKGROUND
Fatigue is one of the major health conditions induced by excessive stress or abnormal immune function or defective antioxidant systems. Placental extract has been reported to have various effects such as immune modulation and cellular regeneration. Fermented porcine placenta (FPP) is a safe nontoxic material, which is highly valuable as a functional food. The aim of this study was to investigate the anti-fatigue effects of FPP supplementation compared with a placebo product.
METHODS
In this double-blind, parallel, randomized, and placebo-controlled trial 84 healthy males and females, aged between 30 and 60 years were randomized to 320 mg of FPP once daily or placebo. The main outcome measures included efficacy of fatigue-inducing treadmill exercise on physical fatigue and fatigue-related parameters based on the questionnaire administered.
RESULTS
The IL-1β mRNA expression and fatigue severity scale were changed significantly after 8 weeks of treatment with fermented porcine placenta compared with placebo ( p < 0.05). Cortisol levels were significantly improved in participants younger than 45 years following treatment with FPP compared with placebo. Furthermore, the lactate and myoglobin levels were improved significantly in participants with BMI ≥ 23 kg/m 2 ( p = 0.045 and p = 0.011, respectively) following treatment with FPP versus placebo.
CONCLUSIONS
Our study showed that FPP supplementation significantly ameliorated fatigue-related parameters and subjective symptoms in healthy adults. Therefore, our results indicate that FPP supplementation induced anti-fatigue effect by regulating the inflammatory response.",2020,The IL-1β mRNA expression and fatigue severity scale were changed significantly after 8 weeks of treatment with fermented porcine placenta compared with placebo ( p < 0.05).,"['Healthy Adults', 'healthy adults', '84 healthy males and females, aged between 30 and 60 years']","['Fermented Porcine Placental Extract', 'FPP', 'FPP supplementation', 'placebo', 'placebo product', 'Fermented porcine placenta (FPP', 'Placebo', 'FPP once daily or placebo']","['Fatigue-Related Parameters', 'efficacy of fatigue-inducing treadmill exercise on physical fatigue and fatigue-related parameters based on the questionnaire administered', 'Cortisol levels', 'fatigue-related parameters and subjective symptoms', 'lactate and myoglobin levels', 'IL-1β mRNA expression and fatigue severity scale']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0032048', 'cui_str': 'Placental Extracts'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0202142', 'cui_str': 'Myoglobin measurement, urine'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",84.0,0.700946,The IL-1β mRNA expression and fatigue severity scale were changed significantly after 8 weeks of treatment with fermented porcine placenta compared with placebo ( p < 0.05).,"[{'ForeName': 'Dong Hyun', 'Initials': 'DH', 'LastName': 'Yoon', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, Seoul 08826, Korea.'}, {'ForeName': 'Ga-Young', 'Initials': 'GY', 'LastName': 'Han', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, Seoul 08826, Korea.'}, {'ForeName': 'Su Seung', 'Initials': 'SS', 'LastName': 'Hwang', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, Seoul 08826, Korea.'}, {'ForeName': 'Dong Won', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, Seoul 08826, Korea.'}, {'ForeName': 'Jin-Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA 6027, Australia.'}, {'ForeName': 'Keunwon', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'LG Household & Healthcare Research Park, Seoul 07795, Korea.'}, {'ForeName': 'Jongbae', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'LG Household & Healthcare Research Park, Seoul 07795, Korea.'}, {'ForeName': 'Wook', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Health and Exercise Science Laboratory, Institute of Sports Science, Seoul National University, Seoul 08826, Korea.'}]",Nutrients,['10.3390/nu12103086']
3226,33050630,Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial.,"The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.",2020,"MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes.","['Women with Fibromyalgia', '41 FM patients']","['mindfulness plus amygdala and insula retraining (MAIR', 'Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR', 'MAIR', 'MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual', 'relaxation therapy (RT']","['pain catastrophizing and psychological inflexibility', 'BDNF', 'BDNF levels', 'immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP', 'functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion', 'immune-inflammatory markers and brain-derived neurotrophic factor (BDNF', 'clinical severity and health-related quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",41.0,0.10071,"MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes.","[{'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Sanabria-Mazo', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Montero-Marin', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford OX3 7JX, UK.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Feliu-Soler', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Gasión', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, 50009 Zaragoza, Spain.'}, {'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Navarro-Gil', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, 50009 Zaragoza, Spain.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Morillo-Sarto', 'Affiliation': 'Basic Psychology Department, Faculty of Psychology, University of Zaragoza, 44003 Teruel, Spain.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Colomer-Carbonell', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Borràs', 'Affiliation': 'Faculty of Psychology, Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), 08193 Barcelona, Spain.'}, {'ForeName': 'Mattie', 'Initials': 'M', 'LastName': 'Tops', 'Affiliation': 'Developmental and Educational Psychology Unit, Leiden University, 233 AK Leiden, The Netherlands.'}, {'ForeName': 'Juan V', 'Initials': 'JV', 'LastName': 'Luciano', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'García-Campayo', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, 50009 Zaragoza, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9103246']
3227,33053823,"Vitamin D Supplementation Does Not Impact Resting Metabolic Rate, Body Composition and Strength in Vitamin D Sufficient Physically Active Adults.","Supplementation with the most efficient form of Vitamin D (VitD3) results in improvements in energy metabolism, muscle mass and strength in VitD deficient individuals. Whether similar outcomes occur in VitD sufficient individuals' remains to be elucidated. The aim of this study is to determine the effect of VitD3 supplementation on resting metabolic rate (RMR), body composition and strength in VitD sufficient physically active young adults. Participants completed pre-supplementation testing before being matched for sunlight exposure and randomly allocated in a counterbalanced manner to the VitD3 or placebo group. Following 12 weeks of 50 IU/kg body-mass VitD3 supplementation, participants repeated the pre-supplementation testing. Thirty-one adults completed the study (19 females and 12 males; mean ± standard deviation (SD); age = 26.6 ± 4.9 years; BMI = 24.2 ± 4.1 kg·m 2 ). The VitD group increased serum total 25(OH)D by 30 nmol/L while the placebo group decreased total serum concentration by 21 nmol/L, reaching 123 (51) and 53 (42.2) nmol/L, respectively. There were no significant changes in muscle strength or power, resting metabolic rate and body composition over the 12-week period. Physically active young adults that are VitD sufficient have demonstrated that no additional physiological effects of achieving supraphysiological serum total 25(OH)D concentrations after VitD3 supplementation.",2020,"There were no significant changes in muscle strength or power, resting metabolic rate and body composition over the 12-week period.","['Physically active young adults', 'VitD sufficient physically active young adults', 'Thirty-one adults completed the study (19 females and 12 males; mean ± standard deviation (SD); age = 26.6 ± 4.9 years; BMI = 24.2 ± 4.1 kg·m 2 ', 'VitD deficient individuals']","['Vitamin D Supplementation', 'placebo', 'VitD3 or placebo', 'VitD3 supplementation', 'Vitamin D (VitD3']","['muscle strength or power, resting metabolic rate and body composition', 'resting metabolic rate (RMR), body composition and strength', 'total serum concentration', 'serum total 25(OH)D', 'energy metabolism, muscle mass and strength']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0919758', 'cui_str': 'Vitamin D measurement'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0523979', 'cui_str': 'Vitamin D3 measurement'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}]",31.0,0.13748,"There were no significant changes in muscle strength or power, resting metabolic rate and body composition over the 12-week period.","[{'ForeName': 'Karina Romeu', 'Initials': 'KR', 'LastName': 'Montenegro', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, Curtin Health Innovation Research Institute, Curtin University, Perth, WA 6102, Australia.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Cruzat', 'Affiliation': 'Faculty of Health, Torrens University Australia, Melbourne, VIC 3000, Australia.'}, {'ForeName': 'Hilton', 'Initials': 'H', 'LastName': 'Melder', 'Affiliation': 'Faculty of Health, Torrens University Australia, Melbourne, VIC 3000, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacques', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, WA 6102, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Newsholme', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, Curtin Health Innovation Research Institute, Curtin University, Perth, WA 6102, Australia.'}, {'ForeName': 'Kagan J', 'Initials': 'KJ', 'LastName': 'Ducker', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, WA 6102, Australia.'}]",Nutrients,['10.3390/nu12103111']
3228,33053843,Effect of Omega-3 Long Chain Polyunsaturated Fatty Acids (n-3 LCPUFA) Supplementation on Cognition in Children and Adolescents: A Systematic Literature Review with a Focus on n-3 LCPUFA Blood Values and Dose of DHA and EPA.,"Omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFA) supplementation in the cardiovascular field is effective if a certain Omega-3 index (O3I) is achieved or the daily n-3 LCPUFA dose is high enough. Whether this applies to studies on cognition in children and adolescents is unclear. The aims of the current review were to investigate whether: (1) a certain O3I level and (2) a minimum daily n-3 LCPUFA dose are required to improve cognition in 4-25 year olds. Web of Science and PubMed were searched. Inclusion criteria: placebo controlled randomized controlled trial; participants 4-25 years; supplementation with docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA); assessing cognition; in English and ≥10 participants per treatment arm. Thirty-three studies were included, 21 in typically developing participants, 12 in those with a disorder. A positive effect on cognitive measures was more likely in studies with an increase in O3I to >6%. Half of the studies in typically developing children with daily supplementation dose ≥450 mg DHA + EPA showed improved cognition. For children with a disorder no cut-off value was found. In conclusion, daily supplementation of ≥450 mg DHA + EPA per day and an increase in the O3I to >6% makes it more likely to show efficacy on cognition in children and adolescents.",2020,"In conclusion, daily supplementation of ≥450 mg DHA + EPA per day and an increase in the O3I to >6% makes it more likely to show efficacy on cognition in children and adolescents.","['Thirty-three studies were included, 21 in typically developing participants, 12 in those with a disorder', 'English and ≥10 participants per treatment arm', 'Children and Adolescents', 'children and adolescents']","['DHA + EPA', 'Omega-3 Long Chain Polyunsaturated Fatty Acids (n-3 LCPUFA) Supplementation', 'Omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFA) supplementation', 'placebo', 'docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA']","['cognitive measures', 'cognition']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.151666,"In conclusion, daily supplementation of ≥450 mg DHA + EPA per day and an increase in the O3I to >6% makes it more likely to show efficacy on cognition in children and adolescents.","[{'ForeName': 'Inge S M', 'Initials': 'ISM', 'LastName': 'van der Wurff', 'Affiliation': 'Conditions for Lifelong Learning, Faculty of Educational Sciences, Open University of the Netherlands, 6419 Heerlen, The Netherlands.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Meyer', 'Affiliation': 'School of Medicine, Lipid Research Centre, Molecular Horizons, Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Renate H M', 'Initials': 'RHM', 'LastName': 'de Groot', 'Affiliation': 'Conditions for Lifelong Learning, Faculty of Educational Sciences, Open University of the Netherlands, 6419 Heerlen, The Netherlands.'}]",Nutrients,['10.3390/nu12103115']
3229,33063705,"Exploring the safety and effectiveness of subcutaneous autologous serum therapy versus conventional intramuscular autologous serum therapy in chronic urticaria: An observer-blind, randomized, controlled study.","Background
Autologous serum therapy aims to supplement the existing pharmacotherapy in chronic urticaria by decreasing the antihistamine pill-burden and maintaining symptom-free interval. Subcutaneous autologous serum therapy further modifies the amount of serum (2 mL to 1 mL) and gauge of a needle (24G to 31G) to improve compliance and facilitate ease of application.
Objectives
To assess clinical effectiveness and safety of subcutaneous autologous serum therapy versus conventional intramuscular autologous serum therapy and to compare the quality of life in the two treatment arms.
Methods
Institution-based, assessor-blind, prospective, randomized, parallel-group, active-controlled trial with 32 patients in each treatment arm and analyzed on a modified intention to treat principle. After baseline autologous serum skin test, autologous serum was injected as per randomization every week for 9 consecutive weeks.
Results
Among the study population, conventional intramuscular autologous serum therapy and subcutaneous autologous serum therapy had a comparable duration of disease (P = 0.164, Mann-Whitney U test), autoreactive status (P = 0.796), urticaria total severity score (P = 0.637) and urticaria activity score summed up over 7 days (P = 0.982). Both urticaria activity score summed up over 7 days and total severity score along with antihistamine pill-burden reduced significantly (P < 0.001, Friedman's analysis of variance) in both subcutaneous autologous serum therapy and conventional intramuscular autologous serum therapy from first follow-up onwards (P < 0.05, Post hoc Dunn's test). Significant improvement was noted in patient's as well as physician's global assessment of disease activity improvement scale (P < 0.001, Friedman's analysis of variance). Intergroup analysis showed that there was no significant difference in urticaria activity score summed up over 7 days either at baseline (P = 0.982, Mann-Whitney U test) or at study end (P = 0.398, Mann-Whitney U test). Similar comparable results were found in the total severity score at the end of the study (P = 0.345, Mann-Whitney U test). Dermatology life quality index showed marked improvement with both types of treatment (P < 0.0001, Wilcoxon test), and the intergroup comparison showed comparable dermatology life quality index values (P = 0.994, Mann-Whitney U test). The pain score at the injection site was more with conventional intramuscular autologous serum therapy than subcutaneous autologous serum therapy (P = 0.0115, Mann-Whitney test). Younger age and lower baseline total severity scores were associated with a better therapeutic response. Baseline urticaria activity score added up over a period of 7 days and total severity scores and the diameter of lesions showed a positive correlation with response pattern.
Limitation
Basophil histamine release assay not done. Logistics could not support follow-up beyond the end of treatment.
Conclusion
Subcutaneous autologous serum therapy is not inferior to conventional intramuscular autologous serum therapy with the additional advantage of less pain and operational feasibility.",2020,"Dermatology life quality index showed marked improvement with both types of treatment (P < 0.0001, Wilcoxon test), and the intergroup comparison showed comparable dermatology life quality index values (P = 0.994, Mann-Whitney U test).",['chronic urticaria'],"['conventional intramuscular autologous serum therapy and subcutaneous autologous serum therapy', 'subcutaneous autologous serum therapy', 'conventional intramuscular autologous serum therapy', 'Subcutaneous autologous serum therapy']","['total severity score', 'dermatology life quality index values', 'safety and effectiveness', 'Dermatology life quality index', 'Baseline urticaria activity score', 'total severity scores', 'duration of disease', 'autoreactive status', 'pain score', 'quality of life', 'urticaria activity score', ""physician's global assessment of disease activity improvement scale"", 'urticaria total severity score']","[{'cui': 'C0263338', 'cui_str': 'Chronic urticaria'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0242348', 'cui_str': 'Serotherapy'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",32.0,0.0238133,"Dermatology life quality index showed marked improvement with both types of treatment (P < 0.0001, Wilcoxon test), and the intergroup comparison showed comparable dermatology life quality index values (P = 0.994, Mann-Whitney U test).","[{'ForeName': 'Adrija', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Department of Dermatology, Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Somodyuti', 'Initials': 'S', 'LastName': 'Chandra', 'Affiliation': 'Department of Dermatology, Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Abanti', 'Initials': 'A', 'LastName': 'Saha', 'Affiliation': 'Department of Dermatology, Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Sil', 'Affiliation': 'Department of Pharmacology, Rampurhat Government Medical College, Rampurhat, West Bengal, India.'}, {'ForeName': 'Nilay Kanti', 'Initials': 'NK', 'LastName': 'Das', 'Affiliation': 'Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India.'}]","Indian journal of dermatology, venereology and leprology",['10.4103/ijdvl.IJDVL_577_19']
3230,33064250,A Coloured Pen Needle Education System Improves Insulin Site Rotation Habits: Results of a Randomized Study.,"INTRODUCTION
Needle reuse and repeated injection of insulin into the same site encourage lipohypertrophy. We explored the potential of coupling a novel pen needle strategy with community pharmacists to improve injection site rotation.
METHODS
Between October 2018 and January 2019, adult insulin users with type 1 or 2 diabetes were enrolled by 16 community pharmacists across 7 Canadian provinces and randomized to their usual pen needles (control) or coloured pen needles packaged with education materials in boxes with reminder sound chips (intervention [mCPN]). A total of 203 individuals completed all requirements of the 30-day study. The primary outcome was a composite of the number of zones injected, the use of new injection zones if the number of zones equaled that at baseline, and the change in size of the injection area from baseline. The pharmacists completed two questionnaires, which provided insights into whether study participation elevated their comfort and confidence in providing injection site rotation counselling.
RESULTS
Compared to the control group, more participants in the mCPN arm improved their site rotation practices (54.1% vs. 33.7%; P = 0.005), 15 more increased the number of injection zones used (P = 0.03), and there was less needle reuse (25% vs. 12% reduction). The pharmacists reported improved knowledge of the consequences of lipohypertrophy and the proportion who were ""very comfortable"" with pen needle tip selection and use rose from 31.3% pre-study to 93.8% post-study.
CONCLUSION
The coloured pen needles with their education materials are a novel means of encouraging injection site rotation. Community pharmacists represent an untapped resource for improving injection self-care practices.",2020,"The pharmacists reported improved knowledge of the consequences of lipohypertrophy and the proportion who were ""very comfortable"" with pen needle tip selection and use rose from 31.3% pre-study to 93.8% post-study.
","['Between October 2018 and January 2019', 'adult insulin users with type 1 or 2 diabetes were enrolled by 16 community pharmacists across 7 Canadian provinces and randomized to their', '203 individuals completed all requirements of the 30-day study']",['usual pen needles (control) or coloured pen needles packaged with education materials in boxes with reminder sound chips (intervention [mCPN'],"['needle reuse', 'number of injection zones', 'Insulin Site Rotation Habits', 'site rotation practices', 'composite of the number of zones injected, the use of new injection zones if the number of zones equaled that at baseline, and the change in size of the injection area from baseline']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0402003', 'cui_str': 'Community pharmacist'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0070220', 'cui_str': 'penclomedine'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",203.0,0.0486174,"The pharmacists reported improved knowledge of the consequences of lipohypertrophy and the proportion who were ""very comfortable"" with pen needle tip selection and use rose from 31.3% pre-study to 93.8% post-study.
","[{'ForeName': 'Lori D', 'Initials': 'LD', 'LastName': 'Berard', 'Affiliation': 'Nurse Consultant, Winnipeg, Manitoba, Canada. ldberard@gmail.com.'}, {'ForeName': 'Sherri A', 'Initials': 'SA', 'LastName': 'Pockett', 'Affiliation': 'St. Boniface General Hospital, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Roscoe', 'Affiliation': 'R2 Consulting Ltd, Diabetes Education Centre, Saint John Regional Hospital, Saint John, New Brunswick, Canada.'}, {'ForeName': 'Rick L', 'Initials': 'RL', 'LastName': 'Siemens', 'Affiliation': 'London Drugs Pharmacy, Lethbridge, Alberta, Canada.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00939-2']
3231,33059771,"Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES
To evaluate the efficacy of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac in symptomatic individuals, with virological confirmation of COVID-19, two weeks after the completion of the two-dose vaccination regimen, aged 18 years or older who work as health professionals providing care to patients with possible or confirmed COVID-19. To describe the occurrence of adverse reactions associated with the administration of each of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac up to one week after vaccination in Adults (18-59 years of age) and Elderly (60 years of age or more).
TRIAL DESIGN
This is a Phase III, randomized, multicenter, endpoint driven, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac. The adsorbed vaccine COVID-19 (inactivated) produced by Sinovac (product under investigation) will be compared to placebo. Voluntary participants will be randomized to receive two intramuscular doses of the investigational product or the placebo, in a 1: 1 ratio, stratified by age group (18 to 59 years and 60 years or more) and will be monitored for one year by active surveillance of COVID-19. Two databases will be established according to the age groups: one for adults (18-59 years) and one for the elderly (60 years of age or older). The threshold to consider the vaccine efficacious will be to reach a protection level of at least 50%, as proposed by the World Health Organization and the FDA. Success in this criterion will be defined by sequential monitoring with adjustment of the lower limit of the 95% confidence interval above 30% for the primary efficacy endpoint.
PARTICIPANTS
Healthy participants and / or participants with clinically controlled disease, of both genders, 18 years of age or older, working as health professionals performing care in units specialized in direct contact with people with possible or confirmed cases of COVID-19. Participation of pregnant women and those who are breastfeeding, as well as those intending to become pregnant within three months after vaccination will not be allowed. Participants will only be included after signing the voluntary Informed Consent Form and ensuring they undergo screening evaluation and conform to all the inclusion and exclusion criteria. All the clinical sites are located in Brazil.
INTERVENTION AND COMPARATOR
Experimental intervention: The vaccine was manufactured by Sinovac Life Sciences (Beijing, China) and contains 3 μg/0.5 mL (equivalent to 600 SU per dose) of inactivated SARS-CoV-2 virus, and aluminium hydroxide as adjuvant. Control comparator: The placebo contains aluminium hydroxide in a 0.5 mL solution The schedule of both, experimental intervention and placebo is two 0.5 mL doses IM (deltoid) with a two week interval.
MAIN OUTCOMES
The primary efficacy endpoint is the incidence of symptomatic cases of virologically confirmed COVID-19 two weeks after the second vaccination. The virological diagnosis will be confirmed by detection of SARS-CoV-2 nucleic acid in a clinical sample. The primary safety endpoint is the frequency of solicited and unsolicited local and systemic adverse reactions during the period of one week after vaccination according to age group in adult (18-59 years old) and elder (60 years of age or older) subjects. Adverse reactions are defined as adverse events that have a reasonable causal relationship to vaccination.
RANDOMISATION
There will be two randomization lists, one for each age group, based on the investigational products to be administered, i.e., vaccine or placebo at a 1: 1 ratio. Each randomization list will be made to include up to 11,800 (18-59 year-old) adults, and 1,260 elderly (60 y-o and older) participants, the maximum number of participants needed per age group. An electronic central randomization system will be used to designate the investigational product that each participant must receive.
BLINDING (MASKING)
This trial is designed as a double-blind study to avoid introducing bias in the evaluation of efficacy, safety and immunogenicity. The clinical care team, the professionals responsible for the vaccination and the participants will not know which investigational product will be administered. Only pharmacists or nurses in the study who are responsible for the randomization, separation and blinding of the investigational product will have access to unblinded information. The sponsor's operational team will also remain blind.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
The total number of participants needed to evaluate efficacy, 13,060 participants, satisfies the needed sample size calculated to evaluate safety. Therefore, the total number obtained for efficacy will be the number retained for the study. Up to 13,060 participants are expected to enter the study, with up to 11,800 participants aged 18 to 59 years and 1,260 elderly participants aged 60 and over. Half of the participants of each group will receive the experimental vaccine and half of them will receive the placebo. The recruitment of participants may be modified as recommended by the Data Safety Monitoring Committee at time of the interim unblinded analysis or blind assessment of the COVID-19 attack rate during the study.
TRIAL STATUS
Protocol version 2.0 - 24-Aug-2020. Recruitment started on July 21 st , 2020. The recruitment is expected to conclude in October 2020.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT0445659 . Registry on 2 July 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,The primary safety endpoint is the frequency of solicited and unsolicited local and systemic adverse reactions during the period of one week after vaccination according to age group in adult (18-59 years old) and elder (60 years of age or older) subjects.,"['symptomatic individuals, with virological confirmation of COVID-19, two weeks after the completion of the two-dose vaccination regimen, aged 18 years or older who work as health professionals providing care to patients with possible or confirmed COVID-19', 'pregnant women', 'Healthy participants and / or participants with clinically controlled disease, of both genders, 18 years of age or older, working as health professionals performing care in units specialized in direct contact with people with possible or confirmed cases of COVID-19', 'Registry on 2 July 2020', 'age groups: one for adults (18-59 years) and one for the elderly (60 years of age or older', 'in Adults (18-59 years of age) and Elderly (60 years of age or more', '11,800 (18-59 year-old) adults, and 1,260 elderly (60 y-o and older) participants, the maximum number of participants needed per age group', '13,060 participants are expected to enter the study, with up to 11,800 participants aged 18 to 59 years and 1,260 elderly participants aged 60 and over', 'Voluntary participants']","['adsorbed vaccine COVID-19 (inactivated) produced by Sinovac up to one week after vaccination', 'adsorbed vaccine COVID-19 (inactivated) produced by Sinovac', 'placebo contains aluminium hydroxide', 'vaccine or placebo', 'vaccine was manufactured by Sinovac Life Sciences (Beijing, China) and contains 3 μg/0.5 mL (equivalent to 600 SU per dose) of inactivated SARS-CoV-2 virus, and aluminium hydroxide', 'placebo', 'adsorbed vaccine COVID-19 (inactivated', 'Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV', 'Placebo']","['frequency of solicited and unsolicited local and systemic adverse reactions', 'efficacy, safety and immunogenicity', 'efficacy and safety', 'Efficacy and Safety', 'incidence of symptomatic cases']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0005526', 'cui_str': 'Biological Sciences'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",2.0,0.413425,The primary safety endpoint is the frequency of solicited and unsolicited local and systemic adverse reactions during the period of one week after vaccination according to age group in adult (18-59 years old) and elder (60 years of age or older) subjects.,"[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Palacios', 'Affiliation': 'Center for Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil. ricardo.palacios@butantan.gov.br.'}, {'ForeName': 'Elizabeth González', 'Initials': 'EG', 'LastName': 'Patiño', 'Affiliation': 'Center for Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'de Oliveira Piorelli', 'Affiliation': 'Center for Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Monica Tilli Reis Pessoa', 'Initials': 'MTRP', 'LastName': 'Conde', 'Affiliation': 'Center for Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Batista', 'Affiliation': 'Center for Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Sinovac Life Sciences, Beijing, China.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Xin', 'Affiliation': 'Sinovac Life Sciences, Beijing, China.'}, {'ForeName': 'Esper G', 'Initials': 'EG', 'LastName': 'Kallas', 'Affiliation': 'Department of Infectious and Parasitic Diseases, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Flores', 'Affiliation': 'PATH US, Washington DC, USA.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Ockenhouse', 'Affiliation': 'PATH US, Washington DC, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gast', 'Affiliation': 'PATH, Seattle, WA, USA.'}]",Trials,['10.1186/s13063-020-04775-4']
3232,33054724,Precision implementation of early ambulation in elderly patients undergoing off-pump coronary artery bypass graft surgery: a randomized-controlled clinical trial.,"BACKGROUND
Although early ambulation (EA) is associated with improved outcomes in post-operative patients, implementation of EA in elderly patients is still a challenge. In this study, we aimed to design and assess a precision early ambulation program for cardiac rehabilitation.
METHODS
We conducted a single-center, randomized and controlled clinical trial in elderly patients aged over 60 years after off-pump coronary artery bypass graft (OPCABG) surgery. Patients were randomly assigned to a precision early ambulation (PEA) group or a routine ambulation (Control) group. Age-predicted maximal heart rate (APMHR) and maximal oxygen uptake (VO 2max) were used as a reference to formulate and monitor the PEA regimen. The primary end-point was the postoperative length of stay in hospital (PLOS). The secondary end-points included 90-day mortality, incidence of early discharge, laboratory tests, length of ICU stay, the incidence of multiple organ complications and post-traumatic stress disorder (PTSD). Ambulation outcomes were also recorded.
RESULTS
In total, 178 patients were enrolled (n = 89 per group). In the intent-to-treat analysis, PLOS in the PEA group was shorter than that in the Control group (9.04 ± 3.08 versus 10.09 ± 3.32 days, respectively. Mean difference 1.045 days; 95% confidence interval [CI] 0.098-1.992; P = 0.031 in the unadjusted model; mean difference 0.957 days; CI 0.007-1.907; P = 0.048 in adjusted model). The incidence of early discharge differed significantly between the PEA and control groups (41[46.1%] versus 24[27.0%] patients, respectively. Odds ratio [OR] 0.432; CI 0.231-0.809; P = 0.009 in unadjusted model; OR 0.466; CI 0.244-0.889, P = 0.02 in adjusted model). The time of first bowel movement, partial pressure O 2 and post-traumatic stress disorder score in the PEA group were better than those in the Control group. Participants walked much longer distances on day 3 in the PEA group than those in the Control group (76.12 ± 29.02 versus 56.80 ± 24.40 m, respectively, P < 0.001).
CONCLUSION
APMHR and VO 2max are valuable for implementation of PEA according to an established security threshold. PEA after OPCAPG surgery is safe and reliable for elderly patients, not only reducing the hospital stay, but also improving their physiological and psychological symptoms.
TRIAL REGISTRATION
This study is a component of a protocol retrospectively registered: Application of ERAS in cardiovascular surgery.
TRIAL REGISTRATION NUMBER
ChiCTR1800018167 . Date of registration: 3rd September, 2018. URL of trial registry record: http://www.chictr.org.cn/index.aspx.",2020,Mean difference 1.045 days; 95% confidence interval [CI] 0.098-1.992; P = 0.031 in the unadjusted model; mean difference 0.957 days; CI 0.007-1.907; P = 0.048 in adjusted model).,"['178 patients were enrolled (n\u2009=\u200989 per group', 'elderly patients aged over 60\u2009years after off-pump coronary artery bypass graft (OPCABG) surgery', 'elderly patients undergoing off-pump coronary artery bypass graft surgery', 'elderly patients']","['ERAS', 'precision early ambulation (PEA) group or a routine ambulation (Control) group', 'OPCAPG surgery', 'http://www.chictr.org.cn/index.aspx', 'PEA']","['hospital stay', 'incidence of early discharge', 'Ambulation outcomes', 'time of first bowel movement, partial pressure O 2 and post-traumatic stress disorder score', 'postoperative length of stay in hospital (PLOS', '90-day mortality, incidence of early discharge, laboratory tests, length of ICU stay, the incidence of multiple organ complications and post-traumatic stress disorder (PTSD', 'maximal heart rate (APMHR) and maximal oxygen uptake (VO 2max']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0013457', 'cui_str': 'Ambulation, Early'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",178.0,0.229864,Mean difference 1.045 days; 95% confidence interval [CI] 0.098-1.992; P = 0.031 in the unadjusted model; mean difference 0.957 days; CI 0.007-1.907; P = 0.048 in adjusted model).,"[{'ForeName': 'Zhaomei', 'Initials': 'Z', 'LastName': 'Cui', 'Affiliation': 'Intensive Care Unit (ICU), Department of Cardiac Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Gynecology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China.'}, {'ForeName': 'Chaonan', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Department of Biostatistics, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China.'}, {'ForeName': 'Yiou', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Toxicological and Functional Test, Centers for Disease Control and Prevention of Shandong, Jinan, 250014, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhuang', 'Affiliation': 'Intensive Care Unit (ICU), Department of Cardiac Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Intensive Care Unit (ICU), Department of Cardiac Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Intensive Care Unit (ICU), Department of Cardiac Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'Intensive Care Unit (ICU), Department of Cardiac Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, Shandong, China. deepblue1229@163.com.'}]",BMC geriatrics,['10.1186/s12877-020-01823-1']
3233,33058035,"Correction to: In shoulder adhesive capsulitis, ultrasound-guided anterior hydrodilatation in rotator interval is more effective than posterior approach: a randomized controlled study.",The authors of the original version of the above article requested to add the name of the instrument that was used in the Intervention section.,2020,The authors of the original version of the above article requested to add the name of the instrument that was used in the Intervention section.,[],['ultrasound-guided anterior hydrodilatation'],[],[],"[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]",[],,0.0456974,The authors of the original version of the above article requested to add the name of the instrument that was used in the Intervention section.,"[{'ForeName': 'Basant', 'Initials': 'B', 'LastName': 'Elnady', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Elsayed M', 'Initials': 'EM', 'LastName': 'Rageh', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Manal Shawky', 'Initials': 'MS', 'LastName': 'Hussein', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohammed Hassan', 'Initials': 'MH', 'LastName': 'Abu-Zaid', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Dalia El-Sayed', 'Initials': 'DE', 'LastName': 'Desouky', 'Affiliation': 'Department of public health and community medicine, Menoufia University, Shibin Al Kawm, Egypt.'}, {'ForeName': 'Tohamy', 'Initials': 'T', 'LastName': 'Ekhouly', 'Affiliation': 'Department of Radiology, Benha University, Benha, Egypt.'}, {'ForeName': 'Johannes J', 'Initials': 'JJ', 'LastName': 'Rasker', 'Affiliation': 'Faculty of Behavioral, Management and Social sciences, Department Psychology, Health and Technology, University of Twente, PO box 217, 7500 AE, Enschede, Netherlands. j.j.rasker@utwente.nl.'}]",Clinical rheumatology,['10.1007/s10067-020-05461-1']
3234,33058158,Targeted therapy for metastatic renal cell carcinoma.,"BACKGROUND
Several comparative randomised controlled trials (RCTs) have been performed including combinations of tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors since the publication of a Cochrane Review on targeted therapy for metastatic renal cell carcinoma (mRCC) in 2008. This review represents an update of that original review.
OBJECTIVES
To assess the effects of targeted therapies for clear cell mRCC in patients naïve to systemic therapy.
SEARCH METHODS
We performed a comprehensive search with no restrictions on language or publication status. The date of the latest search was 18 June 2020.
SELECTION CRITERIA
We included randomised controlled trials, recruiting patients with clear cell mRCC naïve to previous systemic treatment. The index intervention was any TKI-based targeted therapy.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed the included studies and extracted data for the primary outcomes: progression-free survival (PFS), overall survival (OS) and serious adverse events (SAEs); and the secondary outcomes: health-related quality of life (QoL), response rate and minor adverse events (AEs). We performed statistical analyses using a random-effects model and rated the certainty of evidence according to the GRADE approach.
MAIN RESULTS
We included 18 RCTs reporting on 11,590 participants randomised across 18 comparisons. This abstract focuses on the primary outcomes of select comparisons. 1. Pazopanib versus sunitinib Pazopanib may result in little to no difference in PFS as compared to sunitinib (hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.90 to 1.23; 1 study, 1110 participants; low-certainty evidence). Based on the control event risk of 420 per 1000 in this trial at 12 months, this corresponds to 18 fewer participants experiencing PFS (95% CI 76 fewer to 38 more) per 1000 participants. Pazopanib may result in little to no difference in OS compared to sunitinib (HR 0.92, 95% CI 0.80 to 1.06; 1 study, 1110 participants; low-certainty evidence). Based on the control event risk of 550 per 1000 in this trial at 12 months, this corresponds to 27 more OSs (95% CI 19 fewer to 70 more) per 1000 participants. Pazopanib may result in little to no difference in SAEs as compared to sunitinib (risk ratio (RR) 1.01, 95% CI 0.94 to 1.09; 1 study, 1102 participants; low-certainty evidence). Based on the control event risk of 734 per 1000 in this trial, this corresponds to 7 more participants experiencing SAEs (95% CI 44 fewer to 66 more) per 1000 participants. 2. Sunitinib versus avelumab and axitinib Sunitinib probably reduces PFS as compared to avelumab plus axitinib (HR 1.45, 95% CI 1.17 to 1.80; 1 study, 886 participants; moderate-certainty evidence). Based on the control event risk of 550 per 1000 in this trial at 12 months, this corresponds to 130 fewer participants experiencing PFS (95% CI 209 fewer to 53 fewer) per 1000 participants. Sunitinib may result in little to no difference in OS (HR 1.28, 95% CI 0.92 to 1.79; 1 study, 886 participants; low-certainty evidence). Based on the control event risk of 890 per 1000 in this trial at 12 months, this would result in 29 fewer OSs (95% CI 78 fewer to 8 more) per 1000 participants. Sunitinib may result in little to no difference in SAEs (RR 1.01, 95% CI 0.93 to 1.10; 1 study, 873 participants; low-certainty evidence). Based on the control event risk of 705 per 1000 in this trial, this corresponds to 7 more SAEs (95% CI 49 fewer to 71 more) per 1000 participants. 3. Sunitinib versus pembrolizumab and axitinib Sunitinib probably reduces PFS as compared to pembrolizumab plus axitinib (HR 1.45, 95% CI 1.19 to 1.76; 1 study, 861 participants; moderate-certainty evidence). Based on the control event risk of 590 per 1000 in this trial at 12 months, this corresponds to 125 fewer participants experiencing PFS (95% CI 195 fewer to 56 fewer) per 1000 participants. Sunitinib probably reduces OS (HR 1.90, 95% CI 1.36 to 2.65; 1 study, 861 participants; moderate-certainty evidence). Based on the control event risk of 880 per 1000 in this trial at 12 months, this would result in 96 fewer OSs (95% CI 167 fewer to 40 fewer) per 1000 participants. Sunitinib may reduce SAEs as compared to pembrolizumab plus axitinib (RR 0.90, 95% CI 0.81 to 1.02; 1 study, 854 participants; low-certainty evidence) although the CI includes the possibility of no effect. Based on the control event risk of 604 per 1000 in this trial, this corresponds to 60 fewer SAEs (95% CI 115 fewer to 12 more) per 1000 participants. 4. Sunitinib versus nivolumab and ipilimumab Sunitinib may reduce PFS as compared to nivolumab plus ipilimumab (HR 1.30, 95% CI 1.11 to 1.52; 1 study, 847 participants; low-certainty evidence). Based on the control event risk of 280 per 1000 in this trial at 30 months' follow-up, this corresponds to 89 fewer PFSs (95% CI 136 fewer to 37 fewer) per 1000 participants. Sunitinib reduces OS (HR 1.52, 95% CI 1.23 to 1.89; 1 study, 847 participants; high-certainty evidence). Based on the control event risk 600 per 1000 in this trial at 30 months, this would result in 140 fewer OSs (95% CI 219 fewer to 67 fewer) per 1000 participants. Sunitinib probably increases SAEs (RR 1.37, 95% CI 1.22 to 1.53; 1 study, 1082 participants; moderate-certainty evidence). Based on the control event risk of 457 per 1000 in this trial, this corresponds to 169 more SAEs (95% CI 101 more to 242 more) per 1000 participants.
AUTHORS' CONCLUSIONS
Based on the low to high certainty of evidence, several combinations of immune checkpoint inhibitors appear to be superior to single-agent targeted therapy in terms of PFS and OS, and with a favourable AE profile. Some single-agent targeted therapies demonstrated a similar or improved oncological outcome compared to others; minor differences were observed for AE within this group. The certainty of evidence was variable ranging from high to very low and all comparisons were based on single trials.",2020,"Sunitinib reduces OS (HR 1.52, 95% CI 1.23 to 1.89; 1 study, 847 participants; high-certainty evidence).","['patients with clear cell mRCC naïve to previous systemic treatment', 'metastatic renal cell carcinoma (mRCC) in 2008', 'patients naïve to systemic therapy', 'metastatic renal cell carcinoma', '18 RCTs reporting on 11,590 participants randomised across 18 comparisons']","['Sunitinib versus pembrolizumab and axitinib Sunitinib', 'Sunitinib versus avelumab and axitinib Sunitinib', 'Pazopanib', 'Sunitinib versus nivolumab and ipilimumab Sunitinib']","['Sunitinib reduces OS', 'progression-free survival (PFS), overall survival (OS) and serious adverse events (SAEs); and the secondary outcomes: health-related quality of life (QoL), response rate and minor adverse events (AEs', 'oncological outcome', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2931852', 'cui_str': 'Clear-cell metastatic renal cell carcinoma'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]",11590.0,0.363965,"Sunitinib reduces OS (HR 1.52, 95% CI 1.23 to 1.89; 1 study, 847 participants; high-certainty evidence).","[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Hofmann', 'Affiliation': 'Department of Urology, Sunderby Sjukhus, Umeå University, Luleå, Sweden.'}, {'ForeName': 'Eu Chang', 'Initials': 'EC', 'LastName': 'Hwang', 'Affiliation': 'Department of Urology, Chonnam National University Medical School, Chonnam National University Hwasun Hospital, Hwasun, Korea, South.'}, {'ForeName': 'Thomas Bl', 'Initials': 'TB', 'LastName': 'Lam', 'Affiliation': 'Academic Urology Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Bex', 'Affiliation': 'Department of Urology and UCL Division of Surgery and Interventional Science, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Lorenzo So', 'Initials': 'LS', 'LastName': 'Marconi', 'Affiliation': 'Department of Urology and Renal Transplantation, Centro Hospitalar e Universitario de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Börje', 'Initials': 'B', 'LastName': 'Ljungberg', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Umeå University, Umeå, Sweden.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012796.pub2']
3235,33058232,The CRIAA Program complex intervention in primary care to support women and their families in breastfeeding: Study protocol for a pilot trial.,"AIM
To report a pilot study protocol to assess the feasibility of a complex intervention, in the primary healthcare context, to support women and their families in breastfeeding.
DESIGN
A pilot/feasibility trial with control and intervention groups.
METHODS
The study will be conducted in two primary healthcare centres with 40 childbearing women (20 control group; 20 intervention group), with their partner/meaningful person and their respective healthcare professionals. Intervention group participants will receive the intervention: (a) in a breastfeeding workshop during their third trimester of pregnancy; and (b) via virtual breastfeeding support for six months postpartum. Health professionals will be trained to deliver the intervention. The control group will receive standard care in the outpatient clinic. The pilot will help determine the intervention's feasibility. Data collected pre-intervention, 10-days postpartum and two-, four-, and six-months postpartum will provide estimates of the intervention's preliminary effects on self-efficacy and main outcomes. Research Ethics Committee approval was obtained in April 2019.
DISCUSSION
Breastfeeding support is a complex reality influenced by multiple factors. Therefore, approaches to breastfeeding are also, requiring interventions that address its multidimensional nature, including all actors involved. The proposed intervention will be applied by an interdisciplinary professional health team, allowing for its incorporation into standard practice and its perpetual maintenance.
IMPACT
The study will produce an original, comprehensive, complex intervention addressing contextual, and organizational factors to promote breastfeeding support using an interdisciplinary and family-based approach; breastfeeding self-efficacy is the core concept. The program evaluation and feasibility study will permit exploration of the integration of the intervention's novel aspects into the daily work of professionals and reveal how to better use existing resources in a full-scale clinical trial.
TRIAL REGISTRATION
ClinicalTrials.gov ID: NCT03944642.",2020,"The program evaluation and feasibility study will permit exploration of the integration of the intervention's novel aspects into the daily work of professionals and reveal how to better use existing resources in a full-scale clinical trial.
","['two primary healthcare centres with 40 childbearing women (20 control group; 20 intervention group), with their partner/meaningful person and their respective healthcare professionals', 'support women and their families in breastfeeding', 'primary care to support women and their families in breastfeeding']","['complex intervention', 'breastfeeding workshop during their third trimester of pregnancy; and (b) via virtual breastfeeding support for six months postpartum']",[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1171181', 'cui_str': 'Breastfeeding support'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",[],2.0,0.0536521,"The program evaluation and feasibility study will permit exploration of the integration of the intervention's novel aspects into the daily work of professionals and reveal how to better use existing resources in a full-scale clinical trial.
","[{'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Lucchini-Raies', 'Affiliation': 'School of Nursing, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Marquez-Doren', 'Affiliation': 'School of Nursing, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Beca', 'Affiliation': 'School of Medicine, Family Health Center San Alberto Hurtado ANCORA, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'J Carola', 'Initials': 'JC', 'LastName': 'Perez', 'Affiliation': 'Faculty of Psychology, Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Campos', 'Affiliation': 'School of Nursing, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Lopez-Dicastillo', 'Affiliation': 'Faculty of Health Science, Universidad Pública de Navarra, Pamplona, Spain.'}]",Journal of advanced nursing,['10.1111/jan.14534']
3236,33065060,Effects of canagliflozin on anaemia in patients with type 2 diabetes and chronic kidney disease: a post-hoc analysis from the CREDENCE trial.,"BACKGROUND
Sodium-glucose co-transporter 2 inhibitors might enhance erythropoiesis and increase red blood cell mass. We assessed the long-term effects of canagliflozin on anaemia-related outcomes.
METHODS
In a post-hoc analysis of the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, we included patients with type 2 diabetes and chronic kidney disease who were randomly assigned to treatment with canagliflozin or placebo at 690 sites in 34 countries. We assessed the effects of canagliflozin versus matched placebo on haemoglobin and haematocrit using linear mixed-effects models. The primary outcome of this post-hoc analysis was a composite outcome of investigator-reported anaemia or treatment for anaemia, which was assessed using Kaplan-Meier analysis and Cox regression models. All analyses were done by intention to treat.
FINDINGS
Between March 24, 2014, and May 5, 2017, 4401 participants were randomly assigned to receive canagliflozin (100 mg; n=2202) or placebo (n=2199). At baseline, mean haemoglobin concentration was 132·0 g/L (SD 17·7), 1599 (36%) of 4401 participants had anaemia (defined as haemoglobin <130 g/L in men or <120 g/L in women), and 33 (<1%) of 4401 participants used erythropoiesis-stimulating agents. During a median follow-up period of 2·6 years (IQR 2·1-3·1), mean haemoglobin concentration was 7·1 g/L (95% CI 6·4-7·8) higher and haematocrit was 2·4% (2·2-2·6) higher in the canagliflozin group than the placebo group. Overall, 573 of 4401 participants had either an investigator-reported anaemia event or initiation of treatment for anaemia: 358 (8%) of 4401 participants reported anaemia events, 343 (8%) initiated iron preparations, 141 (3%) initiated erythropoiesis-stimulating agents, and 114 (2%) received blood transfusion. The risk of the composite outcome of anaemia events or initiation of treatment for anaemia was lower in the canagliflozin group than the placebo group (hazard ratio 0·65, 95% CI 0·55-0·77; p<0·0001). Compared with the placebo group, participants in the canagliflozin group also had lower risks of anaemia events alone (0·58, 0·47-0·72; p<0·0001), initiation of iron preparations (0·64, 0·52-0·80; p<0·0001), and need for erythropoiesis-stimulating agents (0·65, 0·46-0·91; p=0·012).
INTERPRETATION
These data suggest that canagliflozin reduces the risk of anaemia-associated outcomes, including the need for erythropoiesis-stimulating agents, among patients with type 2 diabetes and chronic kidney disease.
FUNDING
Janssen Research and Development.",2020,"Compared with the placebo group, participants in the canagliflozin group also had lower risks of anaemia events alone (0·58, 0·47-0·72; p<0·0001), initiation of iron preparations (0·64, 0·52-0·80; p<0·0001), and need for erythropoiesis-stimulating agents (0·65, 0·46-0·91; p=0·012).
","['0·65', 'patients with type 2 diabetes and chronic kidney disease', 'Between March 24, 2014, and May 5, 2017, 4401 participants']","['canagliflozin', 'canagliflozin or placebo', 'placebo']","['haematocrit', 'lower risks of anaemia events', 'haemoglobin and haematocrit', 'composite outcome of investigator-reported anaemia or treatment for anaemia', 'anaemia', 'mean haemoglobin concentration', 'anaemia event or initiation of treatment for anaemia', 'blood transfusion', 'anaemia events or initiation of treatment for anaemia', 'anaemia events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",4401.0,0.640331,"Compared with the placebo group, participants in the canagliflozin group also had lower risks of anaemia events alone (0·58, 0·47-0·72; p<0·0001), initiation of iron preparations (0·64, 0·52-0·80; p<0·0001), and need for erythropoiesis-stimulating agents (0·65, 0·46-0·91; p=0·012).
","[{'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Oshima', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Department of Nephrology and Laboratory Medicine, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Brendon L', 'Initials': 'BL', 'LastName': 'Neuen', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Concord Repatriation General Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Edwards', 'Affiliation': 'Janssen Research and Development, Raritan, NJ, USA.'}, {'ForeName': 'Adeera', 'Initials': 'A', 'LastName': 'Levin', 'Affiliation': 'Division of Nephrology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; The Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia; Imperial College London, London, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Pollock', 'Affiliation': 'Kolling Institute of Medical Research, Sydney Medical School, Sydney, NSW, Australia; Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Rosenthal', 'Affiliation': 'Janssen Research and Development, Raritan, NJ, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Department of Nephrology and Laboratory Medicine, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Department of Renal Medicine, University College London, London, UK.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia; Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands. Electronic address: h.j.lambers.heerspink@umcg.nl.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30300-4']
3237,33065070,SGLT2 inhibitors and thiazide enhance excretion of DEHP toxic metabolites in subjects with type 2 diabetes: A randomized clinical trial.,"OBJECTIVE
Phthalates are non-persistent pollutants related to impaired metabolism and high cardiovascular risk. Their toxic metabolites are eliminated through urine and feces. Prevention policies are considered by the governments, although no therapeutic strategy to facilitate their elimination from the human body has been proposed so far. Aim of the present study was to verify, for the first time in humans, whether diuretics might be able to enhance phthalates' toxic metabolites urinary output.
DESIGN AND METHODS
We conducted a two-armed, parallel-design, randomized clinical trial. Thirty patients with type 2 diabetes and hypertension received a four week-treatment with Dapagliflozin 10 mg or Hydrochlorothiazide 12.5 mg. 24-hours urine were collected to measure urinary excretion of three major 2-ethylhexyl-phthalate (DEHP) metabolites, i.e. mono 2-ethylhexyl phthalate (MEHP), mono-2-ethyl-5-oxohexyl phthalate (MEOHP) and mono 2-ethyl-5-hydroxyhexyl phthalate (MEHHP).
RESULTS
24-h urinary excretion of DEHP and MEHP was increased (+44%, p = 0.036; +49%, p = 0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p = 0.016; +36%, p = 0.062). Irrespective of the specific treatment, induced variations of daily urinary eliminations of MEHP metabolites were related with the 24-h urinary sodium (r = 0.42, p = 0.0226) and potassium (r = 0.54, p = 0.0026) excretion. Also, DEHP and MEOHP were related to sodium (r = 0·43, p = 0.0205; r = 0·44, p = 0.0168 respectively) but not to potassium.
CONCLUSIONS
Urinary phthalates excretion seems to occur mainly through sodium- and potassium-related mechanisms, apparently independent from the different diuretic effect. Both thiazide diuretics and SLGT2 inhibitors are effective into the removal of phthalates metabolites from the human body, reducing the human tissues' exposure to their toxicity.",2020,"RESULTS
24-hours urinary excretion of DEHP and MEHP was increased (+44%, p=0.036; +49%, p=0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p=0.016; +36%, p=0.062).","['Thirty patients with type 2 diabetes and hypertension', 'subjects with type 2 diabetes']","['SGLT2 inhibitors and thiazide', 'Dapaglifozin 10 mg or Hydrochlorothiazide', 'thiazide diuretics and SLGT2 inhibitors']","['DEHP toxic metabolites', '24-hours urinary excretion of DEHP and MEHP', 'DEHP and MEOHP', 'urinary excretion of three major 2-ethylhexyl-phthalate (DEHP) metabolites, i.e. mono 2-ethylhexyl phthalate (MEHP), mono-2-ethyl-5-oxohexyl phthalate (MEOHP) and mono 2-ethyl-5-hydroxyhexyl phthalate (MEHHP', '24-hour urinary sodium', 'daily urinary eliminations of MEHP metabolites']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0012197', 'cui_str': 'Di-2-ethylhexyl phthalate'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0220894', 'cui_str': 'Phthalic acid ester'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1320408', 'cui_str': 'Urinary elimination status'}]",30.0,0.0815342,"RESULTS
24-hours urinary excretion of DEHP and MEHP was increased (+44%, p=0.036; +49%, p=0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p=0.016; +36%, p=0.062).","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Mengozzi', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Guiducci', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Parolini', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Biancalana', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy. Electronic address: amalia@ifc.cnr.it.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Solini', 'Affiliation': 'Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy. Electronic address: anna.solini@med.unipi.it.'}]",Environmental research,['10.1016/j.envres.2020.110316']
3238,33065358,Qualitative process evaluation of the Fostering Changes program for foster carers as part of the Confidence in Care randomized controlled trial.,"BACKGROUND
Fostering Changes is an in-service training program for foster carers designed to enhance carer skills, coping strategies and carer-child relationships. The training program has been evaluated in a randomised controlled trial comparing Fostering Changes to usual care.
OBJECTIVE
To conduct a qualitative process evaluation drawing on stakeholder perspectives to describe the logic model of Fostering Changes, identify potential mechanisms of impact of the program and enhance understanding of the trial results.
PARTICIPANTS AND SETTING
Participants were stakeholders in the Fostering Changes program delivered in Wales, UK including foster carers invited to attend the program (18 attendees, eight non-attendees), two program developers, five trainers, 12 social workers who attended or recruited to the program.
METHODS
Total population sampling with qualitative data collection methods. Qualitative data were subject to thematic analysis.
RESULTS
A logic model summarising the program resources, activities and anticipated outcomes was generated. Implementation themes were quality of training, setting and group composition. Mechanisms of impact were identified with themes falling into two categories, group process and skills development. Potential barriers to effectiveness included a poor fit between the carer needs and the program in relation to levels of challenge being faced, age-appropriate content and responsiveness. Contextual factors were also relevant, including the existing relationship between foster carers and the agency and the perceived value of training.
CONCLUSIONS
Although the group aspects of the program were well received, the program itself did not help foster carers deal with more complex challenges and needed to be more targeted in terms of carers needs and circumstances.",2020,"Although the group aspects of the program were well received, the program itself did not help foster carers deal with more complex challenges and needed to be more targeted in terms of carers needs and circumstances.","['Participants were stakeholders in the Fostering Changes program delivered in Wales, UK including foster carers invited to attend the program (18 attendees, eight non-attendees), two program developers, five trainers, 12 social workers who attended or recruited to the program', 'Total population sampling with qualitative data collection methods']",['Fostering Changes program'],[],"[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C3887707', 'cui_str': 'Data Collection Methods'}]","[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0305087,"Although the group aspects of the program were well received, the program itself did not help foster carers deal with more complex challenges and needed to be more targeted in terms of carers needs and circumstances.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Channon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: ChannonS2@cardiff.ac.uk.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Coulman', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: JohnE1@cardiff.ac.uk.'}, {'ForeName': 'Gwenllian', 'Initials': 'G', 'LastName': 'Moody', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: MoodyG@cardiff.ac.uk.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Brookes-Howell', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: Brookes-HowellLC@cardiff.ac.uk.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cannings-John', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: CanningsRL@cardiff.ac.uk.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom. Electronic address: LauTM@cardiff.ac.uk.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Rees', 'Affiliation': ""Children's Social Care Research and Development Centre (CASCADE), School of Social Sciences, Cardiff University, United Kingdom. Electronic address: ReesA1@cardiff.ac.uk.""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Segrott', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom. Electronic address: SegrottJ@cardiff.ac.uk.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scourfield', 'Affiliation': ""Children's Social Care Research and Development Centre (CASCADE), School of Social Sciences, Cardiff University, United Kingdom; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom. Electronic address: Scourfield@cardiff.ac.uk.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, United Kingdom; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom. Electronic address: RoblingMR@cardiff.ac.uk.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104768']
3239,33065408,Biomarker-enhanced VTE risk stratification in ambulatory patients with cancer.,"INTRODUCTION
Risk assessment models are used to stratify cancer patients according to their underlying risk of VTE. The CATS score has been shown to enhance VTE risk stratification as compared to the modified Khorana score by incorporating d-dimer and soluble p-selectin measurements. Our aim was to evaluate the performance of the CATS score with respect to VTE risk stratification.
MATERIALS AND METHODS
Analysis of a subset of the AVERT trial population for whom biomarker data was available. All patients included in the AVERT trial were at increased risk of VTE based on a modified Khorana score of ≥2. Patients were stratified according to the modified Khorana score and CATS score. Kaplan-Meier analysis was used to calculate the 6-month cumulative probabilities of VTE.
RESULTS
A total of 466 patients were included in the analysis, 229 and 237 patients in the placebo and apixaban arms, respectively. The 6-month cumulative probability of VTE among patients with a modified Khorana score ≥ 3 was 13% [95% CI 7 to 23], whereas it was 20% [95% CI 11 to 35] for patients with a CATS score ≥ 4. The absolute risk reduction achieved with apixaban VTE prophylaxis among patients with modified Khorana ≥2, modified Khorana ≥3 and CATS ≥4 was -5.9% [-10.9 to -0.8], -5.8% [-16.0 to 4.5] and -10.1% [-22.9 to 2.6], respectively. Apixaban VTE prophylaxis among patients with increasing modified Khorana or CATS scores was not associated with an increased risk of bleeding events.
CONCLUSIONS
The use of a CATS score of ≥4 to identify ambulatory cancer patients at very high risk of VTE could enhance the benefit/risk ratio achieved with apixaban VTE prophylaxis.",2020,"Apixaban VTE prophylaxis among patients with increasing modified Khorana or CATS scores was not associated with an increased risk of bleeding events.
","['ambulatory patients with cancer', 'ambulatory cancer patients at very high risk of VTE', 'Analysis of a subset of the AVERT trial population for whom biomarker data was available', '466 patients were included in the analysis, 229 and 237 patients in the']",['placebo and apixaban'],"['risk of bleeding events', '6-month cumulative probability of VTE', 'modified Khorana or CATS scores', 'modified Khorana score and CATS score', 'risk of VTE']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",466.0,0.0562162,"Apixaban VTE prophylaxis among patients with increasing modified Khorana or CATS scores was not associated with an increased risk of bleeding events.
","[{'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Shaw', 'Affiliation': 'Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, United States; University of North Carolina Blood Research Center.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Ilich', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, United States; University of North Carolina Blood Research Center.'}, {'ForeName': 'Nigel S', 'Initials': 'NS', 'LastName': 'Key', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, United States; University of North Carolina Blood Research Center.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine, University of Ottawa, and the Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address: pwells@toh.ca.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.035']
3240,33065448,"Effectiveness of a home-based early cognitive-motor intervention provided in daycare, home care, and foster care settings: Changes in motor development and context affordances.","BACKGROUND
Appropriate opportunities within the context are crucial to affect the motor trajectory positively.
OBJECTIVE
To investigate the effectiveness of professional-parental/caregivers' early motor-cognitive intervention on infants' motor development in Daycare (DC), Home Care (HC), and Foster Care (FC). Secondary objectives were to examine if parents and caregivers modified the context to meet the infants' needs and if making modifications was positively associated with infants' development.
METHODS
Participants were 176 infants (DC = 48; HC = 58, FC = 70). Infants' were randomly assigned to intervention (IG) or comparison (CG) groups within each context. The Alberta Infant Motor Scale and Affordances in the Daycare and Home Environment for Motor Development were used. A cognitive-motor intervention was provided for infants in the intervention groups; and, a home-based support protocol for all caregivers and parents.
RESULTS
IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028). Maternal daily care and home opportunities improved for all infants.
CONCLUSIONS
Parents/caregivers' protocol combined with the cognitive-motor intervention lead to better motor outcomes and changes in the context for the IGs. Only the parent/caregivers' protocol was not strong to improve CGs motor outcomes, although changes in context were found. Intensive intervention is need for infants living in vulnerability.",2020,"RESULTS
IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028).","['Infants', 'infants living in vulnerability', 'Participants were 176 infants (DC\xa0=\xa048; HC\xa0=\xa058, FC\xa0=\xa070']","['cognitive-motor intervention', 'intervention (IG) or comparison (CG', ""professional-parental/caregivers' early motor-cognitive intervention"", 'home-based early cognitive-motor intervention', 'Intensive intervention']","['Maternal daily care and home opportunities', ""infants' motor development in Daycare (DC), Home Care (HC), and Foster Care (FC"", 'CGs motor outcomes', 'motor scores']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",176.0,0.0591172,"RESULTS
IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028).","[{'ForeName': 'Nadia Cristina', 'Initials': 'NC', 'LastName': 'Valentini', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, UFRGS, Department of Physical Education, Physiotherapy and Dance, Porto Alegre, Rio Grande do Sul, Brazil. Electronic address: nadiacv@esef.ufrgs.br.'}, {'ForeName': 'Carla Skilhan', 'Initials': 'CS', 'LastName': 'de Almeida', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, UFRGS, Department of Physical Education, Physiotherapy and Dance, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Smith', 'Affiliation': 'University of Southern California, Division of Biokinesiology and Physical Therapy, Los Angeles, CA, USA.'}]",Early human development,['10.1016/j.earlhumdev.2020.105223']
3241,33055176,Incentive programmes for smoking cessation: cluster randomized trial in workplaces in Thailand.,"OBJECTIVE
To compare several monetary incentive programmes for promoting smoking abstinence among employees who smoke at workplaces in a middle income country.
DESIGN
Parallel group, open label, assessor blinded, cluster randomized controlled trial.
SETTING
Large industrial workplaces in metropolitan Bangkok, Thailand.
PARTICIPANTS
Employees who smoked cigarettes and planned to quit within six months recruited from 101 worksite clusters (84 different companies).
INTERVENTIONS
Worksites were digitally cluster randomized by an independent investigator to usual care or usual care plus one of eight types of incentive programmes. Usual care consisted of one time group counseling and cessation support through a 28 day text messaging programme. The incentive programmes depended on abstinence at three months and varied on three intervention components: refundable deposits, assignment to a teammate, and bonus size ($20 (£15; €17) or $40).
MAIN OUTCOME MEASURES
The primary outcome was biochemically verified seven day point prevalence smoking abstinence at 12 months. Secondary outcomes were programme acceptance at enrollment and smoking abstinence at three months (end of intervention) and at six months. All randomized participants who had complete baseline information were included in intention-to-treat analyses; participants with missing outcomes were coded as continuing smokers.
RESULTS
Between April 2015 and August 2016, the trial enrolled 4190 participants. Eighteen were omitted because of missing baseline covariates and death before the primary endpoint, therefore 4172 participants were included in the intention-to-treat analyses. Programme acceptance was relatively high across all groups: 58.7% (2451/4172) overall and 61.3% (271/442) in the usual care group. Abstinence rates at 12 months did not differ among deposit programmes (336/2253, 14.9%) and non-deposit programmes (280/1919, 14.6%; adjusted difference 0.8 points, 95% confidence interval -2.7 to 4.3, P=0.65), but were somewhat lower for team based programmes (176/1348, 13.1%) than individual based programmes (440/2824, 15.6%; -3.2 points, -6.6 to -0.2, P=0.07), and higher for $40 bonus programmes (322/1954, 16.5%) than programmes with no bonus (148/1198, 12.4%; 5.9 points, 2.1 to 9.7, P=0.002). The $40 individual bonus was the most efficacious randomization group at all endpoints. Intervention components did not strongly interact with each other.
CONCLUSIONS
Acceptance of monetary incentive programmes for promoting smoking abstinence was high across all groups. The $40 individual bonus programmes increased long term smoking abstinence compared with usual care, although several other incentive designs did not, such as team based programmes and deposit programmes. Incentive design in workplace wellness programmes might influence their effectiveness at reducing smoking rates in low resource settings.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT02421224).",2020,Programme acceptance was relatively high across all groups: 58.7% (2451/4172) overall and 61.3% (271/442) in the usual care group.,"['employees who smoke at workplaces in a middle income country', 'Large industrial workplaces in metropolitan Bangkok, Thailand', 'Employees who smoked cigarettes and planned to quit within six months recruited from 101 worksite clusters (84 different companies', 'All randomized participants who had complete baseline information were included in intention-to-treat analyses; participants with missing outcomes were coded as continuing smokers', 'Between April 2015 and August 2016', '4190 participants', '4172 participants were included in the intention-to-treat analyses']",['Worksites were digitally cluster randomized by an independent investigator to usual care or usual care plus one of eight types of incentive programmes'],"['Programme acceptance', 'Abstinence rates', 'biochemically verified seven day point prevalence smoking abstinence', 'smoking abstinence', 'long term smoking abstinence', 'programme acceptance at enrollment and smoking abstinence']","[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]",4190.0,0.230203,Programme acceptance was relatively high across all groups: 58.7% (2451/4172) overall and 61.3% (271/442) in the usual care group.,"[{'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'White', 'Affiliation': 'Philip R Lee Institute for Health Policy Studies, University of California, San Francisco, 3333 California Street, Box 0936, San Francisco, CA 94118, USA justin.white@ucsf.edu.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lowenstein', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Nucharee', 'Initials': 'N', 'LastName': 'Srivirojana', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Aree', 'Initials': 'A', 'LastName': 'Jampaklay', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Dow', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA, USA.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m3797']
3242,33055247,Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial.,"OBJECTIVE
To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women.
DESIGN
Parallel group randomised controlled trial.
SETTING
23 community and secondary care centres providing continence care in Scotland and England.
PARTICIPANTS
600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone.
INTERVENTIONS
Participants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments.
MAIN OUTCOME MEASURES
The primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years.
RESULTS
Mean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference -0.09, 95% confidence interval -0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), -£409 to £651, P=0.64) and quality adjusted life years (-0.04, -0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions.
CONCLUSIONS
At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated.
TRIAL REGISTRATION
ISRCTN57756448.",2020,At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups.,"['23 community and secondary care centres', 'stress or mixed urinary incontinence in women', 'urinary incontinence in women', '48 participants', '600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300']","['pelvic floor muscle training with and without electromyographic biofeedback', 'PFMT', 'electromyographic biofeedback with PFMT', 'PFMT plus electromyographic biofeedback and 300 to PFMT alone', 'supervised PFMT and a home PFMT programme', 'pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone', 'supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback']","['severity of urinary incontinence', ""cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years"", 'quality adjusted life years', 'self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity', 'Mean ICIQ-UI SF scores', 'adverse event']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0204624', 'cui_str': 'Electromyographic biofeedback'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4544471', 'cui_str': 'International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",600.0,0.168684,At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups.,"[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK s.hagen@gcu.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stratton', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sergenson', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Bugge', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dean', 'Affiliation': 'College of Medicine and Health, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hay-Smith', 'Affiliation': 'Rehabilitation Teaching and Research Unit, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Kilonzo', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dimitrova', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Fattah', 'Affiliation': ""Aberdeen Centre for Women's Health Research, University of Aberdeen, Foresterhill, Aberdeen, UK.""}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Agur', 'Affiliation': 'Crosshouse Hospital, NHS Ayrshire and Arran, Crosshouse, Kilmarnock, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Booth', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Cathryn', 'Initials': 'C', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Guerrero', 'Affiliation': 'Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Louise R', 'Initials': 'LR', 'LastName': 'Williams', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'McClurg', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow G4 0BA, UK.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m3719']
3243,33059610,The MAKS-s study: multicomponent non-pharmacological intervention for people with severe dementia in inpatient care - study protocol of a randomised controlled trial.,"BACKGROUND
Nursing homes accommodate a large number of people with severe dementia. More than 80% of residents with dementia suffer from behavioural and psychological symptoms, that can have consequences on the perceived burden of the formal caregivers. Internationally, the number of studies on non-pharmacological interventions for people with severe dementia is very small. One way to reduce these symptoms is to meet the needs of people with severe dementia. The non-pharmacological group intervention MAKS-s, which we will investigate in this study, is intended to reduce the behavioural and psychological symptoms and to improve the quality of life of such people. Additionally, we will investigate the effects on the burden carried by formal caregivers.
METHODS
With the present study, we will investigate the effectiveness of a multicomponent non-pharmacological intervention for people with severe dementia living in nursing homes (primary target group). A power analysis indicated that 144 dementia participants should initially be included. In addition, a secondary target group (nursing home staff) will be examined with respect to their dementia-related stress experiences. The study will be conducted as a cluster randomised controlled trail in Germany with a 6-month intervention phase. The nursing homes in the waitlist control group will provide ""care as usual."" The primary endpoints of the study will be the behavioural and psychological symptoms of dementia and the quality of life of people with severe dementia. The total duration of the study will be 18 months. Data will be collected by using observer rating scales.
DISCUSSION
The project has some outstanding quality features. The external validity is high, because it is situated in a naturalistic setting in nursing homes and is being carried out with available nursing employees. Due to this fact, a permanent implementation also seems to be possible. Since the participating nursing homes are disseminated across several German federal states and rural and urban regions, the results should be transferable to the entire population.
TRIAL REGISTRATION
ISRCTN15722923 (Registration date: 07 August 2019).",2020,"The non-pharmacological group intervention MAKS-s, which we will investigate in this study, is intended to reduce the behavioural and psychological symptoms and to improve the quality of life of such people.","['144 dementia participants should initially be included', 'people with severe dementia', 'people with severe dementia living in nursing homes (primary target group', 'people with severe dementia in inpatient care - study protocol']",['multicomponent non-pharmacological intervention'],"['behavioural and psychological symptoms of dementia and the quality of life of people with severe dementia', 'quality of life of such people']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494652', 'cui_str': 'Severe dementia'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494652', 'cui_str': 'Severe dementia'}]",144.0,0.107316,"The non-pharmacological group intervention MAKS-s, which we will investigate in this study, is intended to reduce the behavioural and psychological symptoms and to improve the quality of life of such people.","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Diehl', 'Affiliation': 'Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany. kristina.diehl@uk-erlangen.de.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Kratzer', 'Affiliation': 'Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Graessel', 'Affiliation': 'Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany.'}]",BMC geriatrics,['10.1186/s12877-020-01807-1']
3244,33060432,"Comparison of Rapid Antidepressant and Antisuicidal Effects of Intramuscular Ketamine, Oral Ketamine, and Electroconvulsive Therapy in Patients With Major Depressive Disorder: A Pilot Study.","PURPOSE/BACKGROUND
This study was devised to compare the antidepressant and antisuicidal effects of oral and intramuscular (IM) ketamine versus electroconvulsive therapy (ECT).
METHODS/PROCEDURES
In our pilot study, 45 patients with major depressive disorder (based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria) in the age range of 18 to 70 years who were determined suitable candidates for ECT got randomly divided into 3 equal groups. Each group received one of these treatment modalities: 0.5 mg/kg of IM ketamine; 1 mg/kg of oral ketamine; and ECT in 6 to 9 sessions during 3 weeks. Depression and suicidal ideation scores were recorded using the Hamilton Depression Rating Scale and the Beck Scale for Suicidal Ideation, respectively, at baseline, 24 hours, 1 week, 2 weeks, and 3 weeks within the intervention. The measurements were repeated 1 week and 1 month after the end of the intervention as well. Vital signs and adverse effects were noted. Finally, satisfaction levels of patients for each method were recorded and compared between groups.
FINDINGS/RESULTS
The Hamilton Depression Rating Scale and the Beck Scale for Suicidal Ideation scores significantly improved in all groups compared with baseline with no significant differences between the 3 groups. The adverse effects for ketamine-consuming groups such as dissociative symptoms were brief and transient, whereas memory loss for the ECT group remained up to 1 month in some patients. Ketamine-receiving groups preferred it more than ECT.
IMPLICATIONS/CONCLUSIONS
Oral and IM ketamine probably have equal antidepressant in addition to more antisuicidal effects compared with ECT but had less cognitive adverse effects and higher preference by patients. Thereby, ketamine can be an alternative method in the treatment of patients with severe and/or suicidal MDD.",2020,The Hamilton Depression Rating Scale and the Beck Scale for Suicidal Ideation scores significantly improved in all groups compared with baseline with no significant differences between the 3 groups.,"['45 patients with major depressive disorder (based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria) in the age range of 18 to 70 years who were determined suitable candidates for ECT got randomly divided into 3 equal groups', 'Patients With Major Depressive Disorder', 'patients with severe and/or suicidal MDD']","['ECT', 'Ketamine', 'IM ketamine; 1 mg/kg of oral ketamine; and ECT', 'Intramuscular Ketamine, Oral Ketamine, and Electroconvulsive Therapy', 'ketamine', 'Oral and IM ketamine', 'oral and intramuscular (IM) ketamine', 'electroconvulsive therapy (ECT']","['Depression and suicidal ideation scores', 'cognitive adverse effects', 'Vital signs and adverse effects', 'Hamilton Depression Rating Scale and the Beck Scale for Suicidal Ideation scores', 'satisfaction levels', 'adverse effects', 'Hamilton Depression Rating Scale and the Beck Scale for Suicidal Ideation', 'memory loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002622', 'cui_str': 'Amnesia'}]",45.0,0.0225525,The Hamilton Depression Rating Scale and the Beck Scale for Suicidal Ideation scores significantly improved in all groups compared with baseline with no significant differences between the 3 groups.,"[{'ForeName': 'Dorna', 'Initials': 'D', 'LastName': 'Kheirabadi', 'Affiliation': 'From the Department of Anesthesiology, School of Medicine, Behavioral Sciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Kheirabadi', 'Affiliation': 'Behavioral Sciences Research Center, Department of Psychiatry, School of Medicine.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mirlohi', 'Affiliation': 'Department of Psychiatry, School of Medicine.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Tarrahi', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, IsfahanUniversity of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Norbaksh', 'Affiliation': 'South Coast Specialty Surgery Center.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001289']
3245,33054371,Can Avatar Appearance Influence Physical Activity? User-Avatar Similarity and Proteus Effects on Cardiac Frequency and Step Counts.,"This study combined user-avatar similarity and Proteus effect predictions to incentivize physical activity. 305 participants ran while wearing accelerometers and a heart rate monitor. They were randomly assigned to onscreen motion-capturing avatars displaying either participant or stranger faces dressed in sports or formal clothes. Participants assigned to avatars displaying their own face showed increased cardiac frequency compared with those exposed to avatars with a stranger's face. Relative to the remaining conditions, participants assigned to avatars with their own face also wearing sports clothes showed increased cardiac frequency but participants assigned to avatars with a stranger's face wearing formal clothes showed decreased cardiac frequency. The results imply that user-avatar similarity and the Proteus effect can be harnessed to influence physical activity.",2020,Participants assigned to avatars displaying their own face showed increased cardiac frequency compared with those exposed to avatars with a stranger's face.,['305 participants ran while wearing accelerometers and a heart rate monitor'],['onscreen motion-capturing avatars displaying either participant or stranger faces dressed in sports or formal clothes'],"['Cardiac Frequency and Step Counts', 'cardiac frequency']","[{'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0009072', 'cui_str': 'Garments'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",305.0,0.0167681,Participants assigned to avatars displaying their own face showed increased cardiac frequency compared with those exposed to avatars with a stranger's face.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': 'CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Universitat de Valencia.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Peña', 'Affiliation': 'University of California , Davis.'}, {'ForeName': 'Ausias', 'Initials': 'A', 'LastName': 'Cebolla', 'Affiliation': 'CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Universitat de Valencia.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Baños', 'Affiliation': 'CIBER Fisiopatología Obesidad Y Nutrición (CIBEROBN), Instituto Polibienestar, Universitat de Valencia.'}]",Health communication,['10.1080/10410236.2020.1834194']
3246,33054742,Impact evaluation of scripted lesson plans for HIV-related content in a life orientation curriculum: results from two provinces in South Africa.,"BACKGROUND
Young people under age 25 years are a key population at risk of unintended pregnancies, HIV and other sexually transmitted infections. School-based programming, focusing on youth under 17 years is strategic given that many in this age group are in school or are required to be in school and spend a considerable amount of their time at school. Prior evaluations of school-based HIV prevention programs for young people often employed weak study designs or lacked biomarkers (e.g., HIV or STI testing) to inform outcomes.
METHODS
This study used longitudinal data collected in 2016 from a cohort of grade-8 girls from Mpumalanga and KwaZulu-Natal Provinces in South Africa. We followed them for 2 years to examine the impact of the South African Department of Basic Education's revised scripted lesson plans for the HIV and sexual content of a ""life orientation"" curriculum on knowledge, attitudes, condom use behaviors, pregnancy incidence, and genital herpes incidence. Schools were randomized to intervention and control arms. Multivariable analyses were undertaken using hazard modeling for incidence-based outcomes (genital herpes and pregnancy) and generalized linear latent and mixed modeling for outcomes measured at each time period (knowledge, attitudes, and condom use).
RESULTS
At end line, 105 schools were included from the two provinces (44 from Mpumalanga and 61 from KwaZulu-Natal). Fifty-five were intervention and fifty were control schools. A total of 2802 girls were surveyed at both time periods (1477 intervention and 1325 control). At baseline, participating girls were about 13.6 years; by end line, they were about 2 years older. Longitudinal data demonstrated few differences between intervention and control groups on knowledge, attitudes, condom use, genital herpes, and pregnancy experience. Monitoring data demonstrated that the program was not implemented as intended. Our results demonstrated 7% incidence of genital herpes in the two-year follow-up period indicating sexual risk-taking among our cohort.
CONCLUSIONS
We did not find significant effects of the revised life orientation curriculum on key outcomes; however, this may reflect poor implementation. Future HIV prevention programs for young people need to be implemented with fidelity to ensure they meet the crucial needs of the next generation.
TRIAL REGISTRATION
This study has been registered at ClinicalTrials.gov . The trial registration number is: NCT04205721 . The trial was retrospectively registered on December 18, 2019.",2020,"Longitudinal data demonstrated few differences between intervention and control groups on knowledge, attitudes, condom use, genital herpes, and pregnancy experience.","['2016 from a cohort of grade-8 girls from Mpumalanga and KwaZulu-Natal Provinces in South Africa', 'two provinces in South Africa', 'Young people under age 25\u2009years', '2802 girls were surveyed at both time periods (1477 intervention and 1325 control', 'Fifty-five were intervention and fifty were control schools', '105 schools were included from the two provinces (44 from Mpumalanga and 61 from KwaZulu-Natal']","['school-based HIV prevention programs', 'scripted lesson plans']","['knowledge, attitudes, condom use behaviors, pregnancy incidence, and genital herpes incidence', 'genital herpes', 'knowledge, attitudes, condom use, genital herpes, and pregnancy experience']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019342', 'cui_str': 'Genital herpes simplex'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",2802.0,0.0517119,"Longitudinal data demonstrated few differences between intervention and control groups on knowledge, attitudes, condom use, genital herpes, and pregnancy experience.","[{'ForeName': 'Ilene S', 'Initials': 'IS', 'LastName': 'Speizer', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, 123 W. Franklin St., Chapel Hill, NC, 27516, USA. speizer@email.unc.edu.'}, {'ForeName': 'Mahua', 'Initials': 'M', 'LastName': 'Mandal', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, 123 W. Franklin St., Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Khou', 'Initials': 'K', 'LastName': 'Xiong', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, 123 W. Franklin St., Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Ndinda', 'Initials': 'N', 'LastName': 'Makina', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, 123 W. Franklin St., Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Hattori', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, 123 W. Franklin St., Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Darryn', 'Initials': 'D', 'LastName': 'Durno', 'Affiliation': 'SADC Research Centre, Cape Town, South Africa, USA.'}]",BMC public health,['10.1186/s12889-020-09640-2']
3247,33058835,Exogenous testosterone decreases men's sensitivity to vocal cues of male dominance.,"Assessing dominance is important for effective social interactions, and prior research suggests that testosterone is associated with men's dominance perceptions. The present study tested for a causal effect of exogenous testosterone on men's sensitivity to vocal cues of other men's dominance, an important parameter in male-male competition across species. One hundred and thirty-nine Chinese men received a single dose (150 mg) of testosterone or placebo gel in a double-blind, placebo-controlled, between-participant design. Participants reported their own dominance and judged other men's dominance from voices. Men's dominance sensitivity was significantly weaker in the testosterone group compared to those in the placebo group. Moreover, men's dominance sensitivity was negatively associated with their self-reported dominance in our Chinese sample, consistent with findings from Western populations. These results indicate that exogenous testosterone has a causal effect in decreasing men's dominance sensitivity, consistent with the Challenge Hypothesis, suggesting that the fluctuation of testosterone concentration mediates individuals' behaviors. Additionally, the present study could motivate further work on vocal assessment in the context of competition in humans and other species.",2020,Men's dominance sensitivity was significantly weaker in the testosterone group compared to those in the placebo group.,"['One hundred and thirty-nine Chinese men', ""men's sensitivity to vocal cues of other men's dominance""]","['testosterone or placebo gel', 'Exogenous testosterone', 'testosterone', 'exogenous testosterone', 'placebo']","[""Men's dominance sensitivity""]","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205101', 'cui_str': 'External'}]","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",139.0,0.161778,Men's dominance sensitivity was significantly weaker in the testosterone group compared to those in the placebo group.,"[{'ForeName': 'Chengyang', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Watkins', 'Affiliation': 'Division of Psychology, School of Applied Sciences, Abertay University, Dundee, United Kingdom.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Nan', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Ou', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'School of Business Administration, Zhejiang University of Finance and Economics, Hangzhou, China.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China. Electronic address: yinwu0407@gmail.com.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104871']
3248,33064852,A comparative study between preoperative rectal misoprostol and intraoperative intrauterine administration in the reduction of blood loss during and after cesarean delivery: A randomized controlled trial.,"OBJECTIVE
To compare the efficacy and safety of rectal misoprostol with intrauterine misoprostol in the reduction of blood loss during and after cesarean delivery.
METHODS
Ninety-eight pregnant women, all candidates for elective cesarean delivery, were equally randomized into two groups: the rectal group (received preoperative misoprostol rectally) and the intrauterine group (received intrauterine misoprostol after the delivery of the placenta). The primary outcome was the estimated blood loss (EBL) during cesarean delivery. Secondary outcomes included the occurrence of excessive blood loss (>1000 mL) within the first 24 hours postoperatively and the occurrence of any maternal or fetal side effects.
RESULTS
There were no statistically significant differences between the two groups regarding either the EBL (693.12 ± 139.09 vs 692.39 ± 132.83; P=0.979) or the occurrence of postpartum hemorrhage (>1000 mL) (6.1% vs 4.1%; P=0.99. Apgar scores at 1 and 5 minutes were significantly higher in the intrauterine group compared to the rectal group.
CONCLUSION
Insertion of intrauterine misoprostol is as effective as rectal insertion in reducing blood loss during and after cesarean delivery; however, it has a safer neonatal outcome and is more convenient when administered during cesarean delivery. ClinicalTrials.gov: NCT03723031.",2020,"Apgar scores at 1 and 5 minutes were significantly higher in the intrauterine group compared to the rectal group.
","['Ninety-eight pregnant women, all candidates for elective cesarean delivery', 'during and after cesarean delivery']","['preoperative rectal misoprostol and intraoperative intrauterine administration', 'rectal group (received preoperative misoprostol rectally', 'intrauterine misoprostol', 'intrauterine group (received intrauterine misoprostol', 'rectal misoprostol with intrauterine misoprostol']","['EBL', 'Apgar scores', 'blood loss', 'occurrence of postpartum hemorrhage', 'efficacy and safety', 'occurrence of excessive blood loss', 'occurrence of any maternal or fetal side effects', 'estimated blood loss (EBL']","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",98.0,0.177543,"Apgar scores at 1 and 5 minutes were significantly higher in the intrauterine group compared to the rectal group.
","[{'ForeName': 'Moutaz M', 'Initials': 'MM', 'LastName': 'El-Sherbini', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Maged', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Omneya M', 'Initials': 'OM', 'LastName': 'Helal', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mirna O', 'Initials': 'MO', 'LastName': 'Awad', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'El-Attar', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Jehan A', 'Initials': 'JA', 'LastName': 'Sadek', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'ElKomy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mariam A', 'Initials': 'MA', 'LastName': 'Dawoud', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13426']
3249,33065228,Short and long-term effects of water-based aerobic and concurrent training on cardiorespiratory capacity and strength of older women.,"Studies show that, in the short term, water-based aerobic training (WAT) promotes the same strength gains as water-based concurrent training (WCT). In addition, it is known that some training progression strategy must be employed after the first weeks of training in order to continue stimulating neuromuscular gains. The aim of this paper was to compare the effects of three water-based training on cardiorespiratory capacity and strength of older women in short and long-terms. Fifty-seven participants were randomized into the groups: 1) aerobic training (AT); 2) concurrent training whose resistance training progressed to the use of resistive equipment (CTRE); and 3) concurrent training whose resistance training progressed to multiple sets (CTMS). Participants trained twice a week for 16 weeks. An incremental treadmill test and the one-repetition maximal test of knee extensors were performed before and after 8 and 16 weeks. Peak oxygen consumption showed similar increases from pre to post-16 weeks (AT: 9%, CTRE: 11%, CTMS: 5%). Oxygen consumption at the second ventilatory threshold and strength were increased from pre to post-8 weeks (AT: 15%, CTRE: 16%, CTMS: 3% and AT: 9%, CTRE: 5%, CTMS: 9%, respectively) and from post-8 to post-16 weeks (AT: 6%, CTRE: 3%, CTMS: 12% and AT: 4%, CTRE: 8%, CTMS: 4%, respectively). In conclusion, the three training programs promoted similar increases in the cardiorespiratory capacity and WAT promoted similar strength gains as WCT in short and long terms. Moreover, the use of resistive equipment and the increase in the number of sets are effective progression strategies.",2020,Peak oxygen consumption showed similar increases from pre to post-16 weeks,"['older women', 'Fifty-seven participants', 'older women in short and long-terms']","['aerobic training (AT); 2) concurrent training whose resistance training progressed to the use of resistive equipment (CTRE); and 3) concurrent training whose resistance training progressed to multiple sets (CTMS', 'CTMS', 'three water-based training', 'water-based aerobic and concurrent training', 'water-based aerobic training (WAT']","['cardiorespiratory capacity and strength', 'Peak oxygen consumption', 'Oxygen consumption', 'strength gains']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0661732', 'cui_str': 'cyclohexane-1,2,4-tris(methylenesulfonate)'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",57.0,0.0184618,Peak oxygen consumption showed similar increases from pre to post-16 weeks,"[{'ForeName': 'Thaís', 'Initials': 'T', 'LastName': 'Reichert', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. Electronic address: thais_reichert@hotmail.com.'}, {'ForeName': 'Rochelle Rocha', 'Initials': 'RR', 'LastName': 'Costa', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Artur Avelino Birk', 'Initials': 'AAB', 'LastName': 'Preissler', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Henrique Bianchi', 'Initials': 'HB', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Cláudia Gomes', 'Initials': 'CG', 'LastName': 'Bracht', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Bruna Machado', 'Initials': 'BM', 'LastName': 'Barroso', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Vitória', 'Initials': 'V', 'LastName': 'de Mello Bones da Rocha', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Andressa Freitas', 'Initials': 'AF', 'LastName': 'Correia', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luiz Fernando Martins', 'Initials': 'LFM', 'LastName': 'Kruel', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2020.111103']
3250,33065273,Spinal manipulation and perineural electrical dry needling in patients with cervicogenic headache: a multicenter randomized clinical trial.,"BACKGROUND CONTEXT
Spinal manipulation, spinal mobilization, and exercise are commonly used in individuals with cervicogenic headache (CH). Dry needling is being increasingly used in the management of CH. However, questions remain about the effectiveness of these therapies and how they compare to each other.
PURPOSE
The present study aims to compare the combined effects of spinal manipulation and dry needling with spinal mobilization and exercise on pain and disability in individuals with CH.
STUDY DESIGN/SETTING
Randomized, multicenter, parallel-group trial.
PATIENT SAMPLE
One hundred forty-two patients (n=142) with CH from 13 outpatient clinics in 10 different states were recruited over a 36-month period.
OUTCOME MEASURES
The primary outcome was headache intensity as measured by the Numeric Pain Rating Scale. Secondary outcomes included headache frequency and duration, disability (Neck Disability Index), medication intake, and the Global Rating of Change (GROC). Follow-up assessments were taken at 1 week, 4 weeks, and 3 months.
METHODS
Patients were randomized to receive upper cervical and upper thoracic spinal manipulation plus electrical dry needling (n=74) or upper cervical and upper thoracic spinal mobilization and exercise (n=68). In addition, the mobilization group also received a program of craniocervical and peri-scapular resistance exercises; whereas, the spinal manipulation group also received up to eight sessions of perineural electrical dry needling. The treatment period for both groups was 4 weeks. The trial was prospectively registered at ClinicalTrials.gov (NCT02373605). Drs Dunning, Butts and Young are faculty within the AAMT Fellowship and teach postgraduate courses in spinal manipulation, spinal mobilization, dry needling, exercise and differential diagnosis. The other authors declare no conflicts of interest. None of the authors received any funding for this study.
RESULTS
The 2 × 4 analysis of covariance revealed that individuals with CH who received thrust spinal manipulation and electrical dry needling experienced significantly greater reductions in headache intensity (F=23.464; p<.001), headache frequency (F=13.407; p<.001), and disability (F=10.702; p<.001) than those who received nonthrust mobilization and exercise at a 3-month follow-up. Individuals in the spinal manipulation and electrical dry needling group also experienced shorter duration of headaches (p<.001) at 3 months. Based on the cutoff score of ≥+5 on the GROC, significantly (X 2 =54.840; p<.001) more patients (n=57, 77%) within the spinal manipulation and electrical dry needling group achieved a successful outcome compared to the mobilization and exercise group (n=10, 15%) at 3-month follow-up. Between-groups effect sizes were large (0.9499%) were of mild or moderate severity. There were no serious AEs. There were no notable effects of any treatment on vital signs, ECGs, physical examination findings, or other laboratory assessments.
CONCLUSIONS
Treatment with AMZ001 BID for 4 weeks improved WOMAC pain sub-scores; however, only QD application conferred nominally statistically significant improvements vs placebo. AMZ001 was generally well tolerated.",2020,"There were no notable effects of any treatment on vital signs, ECGs, physical examination findings, or other laboratory assessments.
","['subjects with knee OA', 'subjects with painful knee osteoarthritis']","['placebo BID [n\xa0=\xa0121], or Voltaren 1% 4-times daily [n\xa0=\xa081', 'AMZ001 once daily (QD)\xa0+\xa0placebo QD', 'placebo, ETD', 'placebo', 'diclofenac gel (AMZ001', 'AMZ001 BID', 'AMZ001 QD', 'AMZ001 QD (ETD']","['PGA score', 'additional efficacy measures (WOMAC total score, WOMAC function and stiffness sub-scores, WOMAC pain weight-bearing and non-weight-bearing sub-scores, ICOAP, chair-stand test, OMERACT-OARSI responder rate, PGA, WPAI, EQ-5D, rescue medication use, satisfaction questionnaire) and safety', 'WOMAC pain sub-scores', 'safety and efficacy', 'EQ-5D VAS score', 'frequency and incidence of adverse events (AEs', 'WPAI overall work impairment score', 'vital signs, ECGs, physical examination findings, or other laboratory assessments', 'WOMAC pain sub-score', 'tolerated', 'pain scores']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0699958', 'cui_str': 'Voltaren'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",444.0,0.649854,"There were no notable effects of any treatment on vital signs, ECGs, physical examination findings, or other laboratory assessments.
","[{'ForeName': 'Asger Reinstrup', 'Initials': 'AR', 'LastName': 'Bihlet', 'Affiliation': 'Nordic Bioscience Clinical Development, Denmark. Electronic address: abi@nordicbio.com.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Byrjalsen', 'Affiliation': 'Nordic Bioscience Clinical Development, Denmark.'}, {'ForeName': 'Lee S', 'Initials': 'LS', 'LastName': 'Simon', 'Affiliation': 'SDG LLC, Cambridge, Massachusetts, United States.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Carrara', 'Affiliation': 'Amzell B.V., Hoofddorp, the Netherlands.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Delpy', 'Affiliation': 'Amzell B.V., Hoofddorp, the Netherlands.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Derne', 'Affiliation': 'Amzell B.V., Hoofddorp, the Netherlands.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.09.007']
3255,33065342,Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study.,"PURPOSE
In the MONALEESA-3 Phase III trial of patients with hormone receptor-positive human epidermal growth factor receptor-negative advanced breast cancer, ribociclib plus fulvestrant significantly improved progression-free survival (PFS) and overall survival (OS). Here, we present patient-reported outcomes from the trial, including health-related quality of life (HRQOL).
METHODS
Patients were randomized (2:1) to receive ribociclib plus fulvestrant or placebo plus fulvestrant. Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire) were assessed using Kaplan-Meier estimates; a stratified Cox regression model was used to estimate the hazard ratio (HR) and 95% CIs.
RESULTS
Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (HR for TTD ≥ 10% = 0.81 [95% CI, 0.62-1.1]). Similar findings were noted for TTD ≥5% (HR = 0.79 [95% CI, 0.61-1.0]) and TTD ≥15% (HR = 0.81 [95% CI, 0.60-1.08]). TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57-1.01]) trended in favor of the ribociclib group, whereas results for fatigue and pain were similar between arms. TTD ≥10% in BPI-SF pain severity index score (HR = 0.77 [95% CI, 0.57-1.05]) and worst pain item score (HR = 0.81 [95% CI, 0.58-1.12]) trended in favor of ribociclib vs placebo.
CONCLUSIONS
In addition to significantly prolonging PFS and OS compared with placebo plus fulvestrant, adding ribociclib to fulvestrant maintains HRQOL.",2020,"RESULTS
Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (","['Patients', 'reference) group ', 'advanced breast cancer', 'patients with hormone receptor-positive human epidermal growth factor receptor-negative advanced breast cancer']","['ribociclib plus fulvestrant or placebo plus fulvestrant', 'Ribociclib plus fulvestrant', 'placebo', 'ribociclib plus fulvestrant', 'ribociclib', 'placebo plus fulvestrant']","['worst pain item score', 'progression-free survival (PFS) and overall survival (OS', 'BPI-SF pain severity index score', 'Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire', 'health-related quality of life (HRQOL', 'fatigue and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087185', 'cui_str': 'Human epidermal growth factor receptor negative'}]","[{'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.436342,"RESULTS
Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany. Electronic address: peter.fasching@uk-erlangen.de.'}, {'ForeName': 'J Thaddeus', 'Initials': 'JT', 'LastName': 'Beck', 'Affiliation': 'Highlands Oncology Group, Fayetteville, AR, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Breast Cancer Research Centre-Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"", Naples, Italy.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Esteva', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Jerusalem', 'Affiliation': 'CHU de Liège, University of Liège, Liège, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Multidisciplinary Breast Centre, Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pivot', 'Affiliation': 'Institut Régional Du Cancer, Strasbourg, France.'}, {'ForeName': 'Giulia V', 'Initials': 'GV', 'LastName': 'Bianchi', 'Affiliation': 'Fondazione IRCCS - Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigación Sanitaria Gregorio Marañón, Ciberonc Geicam, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chandiwana', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Lanoue', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Ridolfi', 'Affiliation': 'Novartis Pharma SAS, Rueil-Malmaison, France.'}, {'ForeName': 'Yingbo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rodriguez Lorenc', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Arnd', 'Initials': 'A', 'LastName': 'Nusch', 'Affiliation': 'Practice for Haematology and Internal Oncology, Velbert, Germany.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.09.008']
3256,17612833,Oxcarbazepine at high dosages for the treatment of alcohol dependence.,,2007,,[],['Oxcarbazepine'],[],[],"[{'cui': 'C0069751', 'cui_str': 'oxcarbazepine'}]",[],,0.0114154,,"[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Martinotti', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Romanelli', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Di Nicola', 'Affiliation': ''}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Reina', 'Affiliation': ''}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Mazza', 'Affiliation': ''}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Janiri', 'Affiliation': ''}]",The American journal on addictions,[]
3257,31419294,"Dose-Dependent Infectivity of Aseptic, Purified, Cryopreserved Plasmodium falciparum 7G8 Sporozoites in Malaria-Naive Adults.","Direct venous inoculation of 3.2 × 103 aseptic, purified, cryopreserved, vialed Plasmodium falciparum (Pf) strain NF54 sporozoites, PfSPZ Challenge (NF54), has been used for controlled human malaria infection (CHMI) in the United States, 4 European countries, and 6 African countries. In nonimmune adults, this results in 100% infection rates. We conducted a double-blind, randomized, dose-escalation study to assess the infectivity of the 7G8 clone of Pf (PfSPZ Challenge [7G8]). Results showed dose-dependent infectivity from 43% for 8 × 102 PfSPZ to 100% for 4.8 × 103 PfSPZ. PfSPZ Challenge (7G8) will allow for more complete assessment by CHMI of antimalarial vaccines and drugs.",2019,Results showed dose-dependent infectivity from 43% for 8x102 PfSPZ to 100% for 4.8x103 PfSPZ.,['malaria-naive adults'],"['7G8 clone of Pf (PfSPZ Challenge [7G8', 'PfSPZ Challenge (7G8']",[],"[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009013', 'cui_str': 'Clones'}]",[],,0.0885804,Results showed dose-dependent infectivity from 43% for 8x102 PfSPZ to 100% for 4.8x103 PfSPZ.,"[{'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Laurens', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Berry', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Travassos', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Strauss', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Adams', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Biraj', 'Initials': 'B', 'LastName': 'Shrestha', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Eappen', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Manoj', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Yonas', 'Initials': 'Y', 'LastName': 'Abebe', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Tooba', 'Initials': 'T', 'LastName': 'Murshedkar', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Anusha', 'Initials': 'A', 'LastName': 'Gunasekera', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Richie', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Christopher V', 'Initials': 'CV', 'LastName': 'Plowe', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Jessie K', 'Initials': 'JK', 'LastName': 'Kennedy', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Gail E', 'Initials': 'GE', 'LastName': 'Potter', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Deye', 'Affiliation': 'Parasitology and International Programs Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'B K L', 'Initials': 'BKL', 'LastName': 'Sim', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz410']
3258,31632735,Treatment of at-level spinal cord injury pain with botulinum toxin A.,"Study design
Randomized, double-blinded, placebo-controlled, cross-over study.
Objective
To explore whether botulinum toxin A (BoNTA) could be effective for treating at-level spinal cord injury (SCI) pain.
Setting
Outpatient SCI clinic, New York, USA.
Methods
Participants were randomized to receive subcutaneous injections of either placebo or BoNTA with follow-up (office visit, telephone, or e-mail) at 2, 4, 8, and 12 weeks to assess the magnitude of pain relief post injection. Crossover of participants was then performed. Those who received placebo received BoNTA, and vice versa, with follow-up at 2, 4, 8, and 12 weeks.
Results
Eight participants completed at least one of the two crossover study arms. Four completed both arms. The median age of the eight participants was 45 years (range 32-61 years) and 75% were male. All had traumatic, T1-L3 level, complete SCI. Although our data did not meet statistical significance, we noted a higher proportion of participants reporting a marked change in average pain intensity from baseline to 8 and 12 weeks post-BoNTA vs. post-placebo (33% vs. 0%). At 2 and 4 weeks post-BoNTA, almost all participants reported some degree of reduced pain, while the same was not seen post-placebo (83% vs. 0%).
Conclusion
The subcutaneous injection of BoNTA may be a feasible approach for the control of at-level SCI pain and is worthy of further study.
Sponsorship
The onabotulinumtoxinA (BOTOX) used in this study was provided by Allergan (Irvine, CA).",2019,"To explore whether botulinum toxin A (BoNTA) could be effective for treating at-level spinal cord injury (SCI) pain.
",['The median age of the eight participants was 45 years (range 32-61 years) and 75% were male'],"['placebo', 'botulinum toxin A (BoNTA', 'botulinum toxin A']","['degree of reduced pain', 'average pain intensity', 'traumatic, T1-L3 level, complete SCI']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",8.0,0.484571,"To explore whether botulinum toxin A (BoNTA) could be effective for treating at-level spinal cord injury (SCI) pain.
","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Chun', 'Affiliation': '1Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}, {'ForeName': 'Isaiah', 'Initials': 'I', 'LastName': 'Levy', 'Affiliation': '2Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}, {'ForeName': 'Ajax', 'Initials': 'A', 'LastName': 'Yang', 'Affiliation': 'The Spine and Pain Institute of New York, New York, NY USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Delgado', 'Affiliation': '1Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}, {'ForeName': 'Chung-Ying', 'Initials': 'CY', 'LastName': 'Tsai', 'Affiliation': '1Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Leung', 'Affiliation': '5Department of Physical Medicine and Rehabilitation, Department of Pain Medicine, Northwell Health Physician Partners, Bay Shore, NY USA.'}, {'ForeName': 'Kristell', 'Initials': 'K', 'LastName': 'Taylor', 'Affiliation': '1Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kolakowsky-Hayner', 'Affiliation': '1Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Huang', 'Affiliation': '1Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Escalon', 'Affiliation': '1Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}, {'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Bryce', 'Affiliation': '1Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}]",Spinal cord series and cases,['10.1038/s41394-019-0221-9']
3259,32072141,"HOVON110/ReBeL Study: Results of the Phase I Part of a Randomized Phase I/II Study of Lenalidomide, Rituximab With or Without Bendamustine in Patients With Relapsed/Refractory Follicular Lymphoma.",Supplemental Digital Content is available in the text.,2020,Supplemental Digital Content is available in the text.,['Patients With Relapsed/Refractory Follicular Lymphoma'],"['Lenalidomide', 'Rituximab With or Without Bendamustine']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}]",[],,0.0126818,Supplemental Digital Content is available in the text.,"[{'ForeName': 'Wendy B C', 'Initials': 'WBC', 'LastName': 'Stevens', 'Affiliation': 'Department of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Bakunina', 'Affiliation': 'HOVON Data Center, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Internal Medicine, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Chamuleau', 'Affiliation': 'Department of Hematology, Amsterdam UMC, VU MC, Amsterdam, The Netherlands.'}, {'ForeName': 'Aart', 'Initials': 'A', 'LastName': 'Beeker', 'Affiliation': 'Department of Oncology, Spaarne Gasthuis, Hoofddorp, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Fijnheer', 'Affiliation': 'Department of Internal Medicine, Meander Medical Center, Amersfoort, The Netherlands.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Hebart', 'Affiliation': 'Department of Internal Medicine, Stauferklinikum Schwäbisch Gmünd, Mutlangen, Germany.'}, {'ForeName': 'Hein P J', 'Initials': 'HPJ', 'LastName': 'Visser', 'Affiliation': 'Department of Internal Medicine, Tergooi Hospital, Hilversum, The Netherlands.'}, {'ForeName': 'Jeanette K', 'Initials': 'JK', 'LastName': 'Doorduijn', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Linton', 'Affiliation': 'Manchester Cancer Research Centre, The Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dreyling', 'Affiliation': 'Department of Medicine III, University hospital, LMU Munich, Germany.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'de Jong', 'Affiliation': 'Department of Pathology, Amsterdam UMC, VU MC, Amsterdam, The Netherlands.'}, {'ForeName': 'Marie José', 'Initials': 'MJ', 'LastName': 'Kersten', 'Affiliation': 'Department of Hematology, Amsterdam UMC, University of Amsterdam and Cancer Center Amsterdam and LYMMCARE (Lymphoma and Myeloma Center Amsterdam), Amsterdam, The Netherlands.'}]",HemaSphere,['10.1097/HS9.0000000000000325']
3260,28465517,A randomized study of pomalidomide vs placebo in persons with myeloproliferative neoplasm-associated myelofibrosis and RBC-transfusion dependence.,,2017,,['persons with myeloproliferative neoplasm-associated myelofibrosis and RBC-transfusion dependence'],['pomalidomide vs placebo'],[],"[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0027022', 'cui_str': 'Myeloproliferative Disorders'}, {'cui': 'C0001815', 'cui_str': 'Idiopathic Myelofibrosis'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}]","[{'cui': 'C2347624', 'cui_str': 'pomalidomide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0190568,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tefferi', 'Affiliation': ''}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Al-Ali', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Barosi', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Devos', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gisslinger', 'Affiliation': ''}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'J-J', 'Initials': 'JJ', 'LastName': 'Kiladjian', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mesa', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Passamonti', 'Affiliation': ''}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'McMullin', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ribrag', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schiller', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Vannucchi', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Reiser', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Gale', 'Affiliation': ''}]",Leukemia,['10.1038/leu.2017.2']
3261,28835978,"Erratum to: Abstracts of the 53rd Annual Meeting of the EASD, Lisbon 2017. Abstract 788: 'Pharmacokinetics and tolerability of oral semaglutide in subjects with renal impairment'.",,2017,,['subjects with renal impairment'],['oral semaglutide'],[],"[{'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}]",[],,0.0143219,,"[{'ForeName': 'T W', 'Initials': 'TW', 'LastName': 'Anderson', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Granhall', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Á', 'Initials': 'Á', 'LastName': 'Réthy', 'Affiliation': 'Péterfy Sándor utcai Kórház, Budapest, Hungary.'}, {'ForeName': 'F L', 'Initials': 'FL', 'LastName': 'Søndergaard', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Thomsen', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}]",Diabetologia,['10.1007/s00125-017-4413-1']
3262,31796480,"Design, development and randomised controlled trial of a smartphone application, 'QinTB', for smoking cessation in tuberculosis patients: study protocol.","INTRODUCTION
Providing smoking cessation treatment is an important intervention for tuberculosis (TB) patients. Mobile technologies, such as smartphone applications, have shown promising potential. However, there are few effective applications that could support TB patients in their efforts to quit smoking. To address this problem, we will develop a smartphone application 'QinTB' to help TB patients quit smoking, and we will evaluate the clinical efficacy of this application by using a randomised controlled trial (RCT).
METHODS AND ANALYSIS
This is a two-step study. In the first step, we will develop a smartphone application based on an interactive application of the transtheoretical model and protection motivation theory. Then, we will perform an RCT using a two-arm design; a total of 400 patients will be randomly assigned to the application group or the doctors' advice group; both treatments will be 6 months and follow-up will be 12 months; the primary outcome is the biochemically verified 6 month sustained abstinence rate; data will be analysed on an intention-to-treat basis.
ETHICS AND DISSEMINATION
This study was approved by the Ethics Committee of Beijing Research Institute for Tuberculosis Control and Prevention. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER
This study was registered in the Chinese Clinical Trial Registry (ChiCTR1900022008) and the stage is Pre-results.",2019,"In the first step, we will develop a smartphone application based on an interactive application of the transtheoretical model and protection motivation theory.","['400 patients', 'tuberculosis (TB) patients', 'tuberculosis patients']","[""smartphone application, 'QinTB""]",[],"[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]",[],400.0,0.157364,"In the first step, we will develop a smartphone application based on an interactive application of the transtheoretical model and protection motivation theory.","[{'ForeName': 'Haoxiang', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Social Medicine and Health Education, School of Public Health, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'International Union Against Tuberculosis and Lung Disease, Paris, France.'}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Social Medicine and Health Education, School of Public Health, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Tobacco Medicine and Tobacco Cessation Center, China-Japan Friendship Hospital, Beijing, China changchun@bjmu.edu.cn lzlzq2004@126.com.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'Department of Social Medicine and Health Education, School of Public Health, Peking University Health Science Center, Beijing, China changchun@bjmu.edu.cn lzlzq2004@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-031204']
3263,30374191,Opioid system modulation with buprenorphine/samidorphan combination for major depressive disorder: two randomized controlled studies.,"The endogenous opioid system is thought to play an important role in the regulation of mood. Buprenorphine/samidorphan (BUP/SAM) combination is an investigational opioid system modulator for adjunctive treatment of major depressive disorder (MDD). To confirm results from early studies, we report the efficacy and safety of BUP/SAM as adjunctive treatment in patients with MDD and an inadequate response to antidepressant therapy (ADT) in FORWARD-4 and FORWARD-5: two phase 3, randomized, double-blind, placebo-controlled studies that utilized the same sequential parallel-comparison design. Efficacy was measured using the Montgomery-Åsberg Depression Rating Scale (MADRS). FORWARD-5 achieved the primary endpoint and demonstrated that adjunctive BUP/SAM 2 mg/2 mg was superior to placebo (average difference change from baseline to week 3 through end of treatment [EOT] in MADRS-6 and -10 versus placebo: -1.5, P = 0.018; -1.9, P = 0.026, respectively). FORWARD-4 did not achieve the primary endpoint (change from baseline in MADRS-10 at week 5 versus placebo: -1.8, P = 0.109), although separate analyses showed significant treatment differences at other timepoints using traditional, regulatory-accepted endpoints such as reduction in MADRS-10 at EOT. The pooled analysis of the two studies demonstrated consistently greater reduction in MADRS-10 scores from baseline for BUP/SAM 2 mg/2 mg versus placebo at multiple timepoints including EOT and average change from baseline to week 3 through EOT (-1.8, P = 0.010; -1.8, P = 0.004, respectively). The overall effect size (Hedges' g) in the pooled analyses for MADRS-10 change from baseline to EOT was 0.22. Overall, BUP/SAM was generally well tolerated, with most adverse events (AEs) being mild or moderate in severity. The most common AEs, occurring in ≥5% of patients in the BUP/SAM 2 mg/2 mg treatment group, which was more frequently than the placebo group, included nausea, constipation, dizziness, vomiting, somnolence, fatigue, and sedation. There was minimal evidence of abuse, and no evidence of dependence or opioid withdrawal by AEs or objective measures. This report describes adjunctive BUP/SAM 2 mg/2 mg combination, a therapy with a novel opioidergic mechanism of action, as a potential new treatment option for patients with MDD who have an inadequate response to currently available ADT.",2020,,['major depressive disorder'],['buprenorphine/samidorphan combination'],[],"[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}]",[],,0.231079,,"[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (CTNI), Harvard Medical School, Boston, MA, USA. MFAVA@mgh.harvard.edu.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine and the Corporal Michael Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Ehrich', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Martin', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Memisoglu', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Nangia', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Arielle D', 'Initials': 'AD', 'LastName': 'Stanford', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0284-1']
3264,32122311,Supporting at-risk older adults transitioning from hospital to home: who benefits from an evidence-based patient-centered discharge planning intervention? Post-hoc analysis from a randomized trial.,"BACKGROUND
Subgroups of older patients experience difficulty performing activities of daily living (ADL) following hospital discharge, as well as unplanned hospital readmissions and emergency department (ED) presentations. We examine whether these subgroups of ""at-risk"" older patients benefit more than their counterparts from an evidence-based discharge planning intervention, on the following outcomes: (1) independence in ADL, (2) participation in life roles, (3) unplanned re-hospitalizations, and (4) ED presentations.
TRIAL DESIGN AND METHODS
This study used data from a randomized control trial involving 400 hospitalized older patients with acute and medical conditions, recruited through 5 sites in Australia. Participants receive either HOME, a patient-centered discharge planning intervention led by an occupational therapist; or a structured in-hospital consultation. HOME uses a collaborative approach for goal setting and includes pre and post-discharge home visits as well as telephone follow-up. Characteristics associated with higher risks of adverse outcomes were recorded and at-risk subgroups were created (mild cognitive impairment, walking difficulty, comorbidity, living alone and no support from family). Independence in ADL and participation in life roles were assessed with validated questionnaires. The number of unplanned re-hospitalizations and ED presentations were extracted from medical files. Linear regression models were conducted to detect variation in response to the intervention at 3-months, according to patients' characteristics.
RESULTS
Analyses revealed significant interaction effects for intervention by cognitive status for unplanned re-hospitalization (p = 0.003) and ED presentations (p = 0.021) at 3 months. Within the at-risk subgroup of mild cognitively impaired, the HOME intervention significantly reduced unplanned hospitalizations (p = 0.027), but the effect did not reach significance in ED visits. While the effect of HOME differed according to support received from family for participation in life roles (p = 0.019), the participation observed in HOME patients with no support was not significantly improved.
CONCLUSIONS
Findings show that hospitalized older adults with mild cognitive impairment benefit from the HOME intervention, which involves preparation and post-discharge support in the environment, to reduce unplanned re-hospitalizations. Improved discharge outcomes in this at-risk subgroup following an occupational therapist-led intervention may enable best care delivery as patients transition from hospital to home.
TRIAL REGISTRATION
The trial was registered before commencement (ACTRN12611000615987).",2020,"While the effect of HOME differed according to support received from family for participation in life roles (p = 0.019), the participation observed in HOME patients with no support was not significantly improved.
","['400 hospitalized older patients with acute and medical conditions, recruited through 5 sites in Australia', 'hospitalized older adults with mild cognitive impairment']","['HOME intervention', 'HOME, a patient-centered discharge planning intervention led by an occupational therapist; or a structured in-hospital consultation']","['Independence in ADL and participation in life roles', 'unplanned hospitalizations', 'cognitive status for unplanned re-hospitalization', 'number of unplanned re-hospitalizations and ED presentations', 'discharge outcomes']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",400.0,0.172697,"While the effect of HOME differed according to support received from family for participation in life roles (p = 0.019), the participation observed in HOME patients with no support was not significantly improved.
","[{'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Provencher', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke Research Centre on Aging, 3001 12e Avenue Nord, Sherbrooke, Québec, J1H 5N4, Canada.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'Faculty of Medicine & Health, The University of Sydney, Sydney, 2006, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Wales', 'Affiliation': 'School of Health Sciences, University of Newcastle, Callaghan, 2308, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Cameron', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': 'College of Nursing and Health Professions, Drexel University, 1601 Cherry Street, Philadelphia, PA, 19102, USA.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Grenier', 'Affiliation': 'Research Center on Aging, 1036 Belvédère Sud, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Natasha A', 'Initials': 'NA', 'LastName': 'Lannin', 'Affiliation': 'Department of Neuroscience, Central Clinical School, Monash University, 99 Commercial Road, Melbourne, 3004, Australia. Natasha.Lannin@monash.edu.'}]",BMC geriatrics,['10.1186/s12877-020-1494-3']
3265,32034908,Looming Vulnerability and Smoking Cessation Attempts.,"INTRODUCTION
The looming vulnerability model holds that people become anxious when they perceive threats as growing larger and accelerating toward them in space and time. Preliminary research suggested that a guided imagery induction designed to activate a sense that health consequences of smoking are a looming threat led more smokers to attempt to quit. This study tested the effect on quit attempts in a larger sample and examined age, sex, and sensation seeking as moderators.
AIMS AND METHODS
Adult smokers (≥10 cigarettes/day) screened for risk of anxiety or mood disorders (N = 278, 52% male; 77% African American) were randomly assigned to receive (1) looming vulnerability or (2) neutral guided imagery exercises. At a 4-week follow-up, they reported quit attempts, smoking rate, self-efficacy, outcome expectancies, and contemplation status.
RESULTS
Those in the looming condition (17%) were no more likely than those in the control condition (20%) to make a quit attempt. There were no significant group differences in expectancies, contemplation, or follow-up smoking rate, and no significant moderators.
CONCLUSIONS
The looming induction was the same one used in earlier work in which it had stronger effects. Those who respond to it with increased urgency about quitting smoking might be offset by others who are more reactant and deny the message. Inconsistencies across studies may reflect differences in inclusion criteria, such that the present sample was on average heavier smokers with longer smoking history and more severe nicotine dependence, yet higher self-efficacy.
IMPLICATIONS
An induction designed to activate a sense that the health consequences of smoking constitute a looming vulnerability failed to increase quit attempts or reduce smoking rate among adult daily smokers. Inconsistencies across studies might reflect varying sample characteristics resulting from changes in screening criteria.",2020,"There were no significant group differences in expectancies, contemplation, or follow-up smoking rate, and no significant moderators.
","['Adult smokers (>= 10 cigarettes/day) screened for risk of anxiety or mood disorders (N = 278, 52% male; 77% African American', 'adult daily smokers']",['looming vulnerability or (b) neutral guided imagery exercises'],"['smoking rate', 'quit attempts, smoking rate, self-efficacy, outcome expectancies, and contemplation status', 'expectancies, contemplation, or follow-up smoking rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.0153101,"There were no significant group differences in expectancies, contemplation, or follow-up smoking rate, and no significant moderators.
","[{'ForeName': 'David A F', 'Initials': 'DAF', 'LastName': 'Haaga', 'Affiliation': 'Department of Psychology, American University, Washington, DC.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Psychology, American University, Washington, DC.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Malloy', 'Affiliation': 'Department of Mathematics and Statistics, American University, Washington, DC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa034']
3266,32267235,Nurse-Physician Communication Team Training in Virtual Reality Versus Live Simulations: Randomized Controlled Trial on Team Communication and Teamwork Attitudes.,"BACKGROUND
Interprofessional team training is needed to improve nurse-physician communication skills that are lacking in clinical practice. Using simulations has proven to be an effective learning approach for team training. Yet, it has logistical constraints that call for the exploration of virtual environments in delivering team training.
OBJECTIVE
This study aimed to evaluate a team training program using virtual reality vs conventional live simulations on medical and nursing students' communication skill performances and teamwork attitudes.
METHODS
In June 2018, the authors implemented nurse-physician communication team training using communication tools. A randomized controlled trial study was conducted with 120 undergraduate medical and nursing students who were randomly assigned to undertake team training using virtual reality or live simulations. The participants from both groups were tested on their communication performances through team-based simulation assessments. Their teamwork attitudes were evaluated using interprofessional attitude surveys that were administered before, immediately after, and 2 months after the study interventions.
RESULTS
The team-based simulation assessment revealed no significant differences in the communication performance posttest scores (P=.29) between the virtual and simulation groups. Both groups reported significant increases in the interprofessional attitudes posttest scores from the baseline scores, with no significant differences found between the groups over the 3 time points.
CONCLUSIONS
Our study outcomes did not show an inferiority of team training using virtual reality when compared with live simulations, which supports the potential use of virtual reality to substitute conventional simulations for communication team training. Future studies can leverage the use of artificial intelligence technology in virtual reality to replace costly human-controlled facilitators to achieve better scalability and sustainability of team-based training in interprofessional education.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04330924; https://clinicaltrials.gov/ct2/show/NCT04330924.",2020,The team-based simulation assessment revealed no significant differences in the communication performance posttest scores (P=.29) between the virtual and simulation groups.,['120 undergraduate medical and nursing students'],"['Virtual Reality Versus Live Simulations', 'team training program using virtual reality vs conventional live simulations', 'team training using virtual reality or live simulations']","['communication performance posttest scores', 'interprofessional attitudes posttest scores']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.09034,The team-based simulation assessment revealed no significant differences in the communication performance posttest scores (P=.29) between the virtual and simulation groups.,"[{'ForeName': 'Sok Ying', 'Initials': 'SY', 'LastName': 'Liaw', 'Affiliation': 'Alice Lee Centre for Nursing Studies, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Sim Win', 'Initials': 'SW', 'LastName': 'Ooi', 'Affiliation': 'National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Khairul Dzakirin Bin', 'Initials': 'KDB', 'LastName': 'Rusli', 'Affiliation': 'Alice Lee Centre for Nursing Studies, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Tang Ching', 'Initials': 'TC', 'LastName': 'Lau', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Wilson Wai San', 'Initials': 'WWS', 'LastName': 'Tam', 'Affiliation': 'Alice Lee Centre for Nursing Studies, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Wei Ling', 'Initials': 'WL', 'LastName': 'Chua', 'Affiliation': 'Alice Lee Centre for Nursing Studies, National University of Singapore, Singapore, Singapore.'}]",Journal of medical Internet research,['10.2196/17279']
3267,31988276,White blood cell and cell-free DNA analyses for detection of residual disease in gastric cancer.,"Liquid biopsies are providing new opportunities for detection of residual disease in cell-free DNA (cfDNA) after surgery but may be confounded through identification of alterations arising from clonal hematopoiesis. Here, we identify circulating tumor-derived DNA (ctDNA) alterations through ultrasensitive targeted sequencing analyses of matched cfDNA and white blood cells from the same patient. We apply this approach to analyze samples from patients in the CRITICS trial, a phase III randomized controlled study of perioperative treatment in patients with operable gastric cancer. After filtering alterations from matched white blood cells, the presence of ctDNA predicts recurrence when analyzed within nine weeks after preoperative treatment and after surgery in patients eligible for multimodal treatment. These analyses provide a facile method for distinguishing ctDNA from other cfDNA alterations and highlight the utility of ctDNA as a predictive biomarker of patient outcome to perioperative cancer therapy and surgical resection in patients with gastric cancer.",2020,"After filtering alterations from matched white blood cells, the presence of ctDNA predicts recurrence when analyzed within nine weeks after preoperative treatment and after surgery in patients eligible for multimodal treatment.","['gastric cancer', 'patients with gastric cancer', 'patients with operable gastric cancer']",[],[],"[{'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}]",[],[],,0.0542167,"After filtering alterations from matched white blood cells, the presence of ctDNA predicts recurrence when analyzed within nine weeks after preoperative treatment and after surgery in patients eligible for multimodal treatment.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Leal', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Nicole C T', 'Initials': 'NCT', 'LastName': 'van Grieken', 'Affiliation': 'Department of Pathology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Doreen N', 'Initials': 'DN', 'LastName': 'Palsgrove', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Phallen', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Medina', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Hruban', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Mark A M', 'Initials': 'MAM', 'LastName': 'Broeckaert', 'Affiliation': 'Department of Pathology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Valsamo', 'Initials': 'V', 'LastName': 'Anagnostou', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Vilmos', 'Initials': 'V', 'LastName': 'Adleff', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Bruhm', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Jenna V', 'Initials': 'JV', 'LastName': 'Canzoniero', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Fiksel', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Nordsmark', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Fabienne A R M', 'Initials': 'FARM', 'LastName': 'Warmerdam', 'Affiliation': 'Department of Medical Oncology, Zuyderland Medical Centre, Sittard-Geleen/Heerlen, Netherlands.'}, {'ForeName': 'Henk M W', 'Initials': 'HMW', 'LastName': 'Verheul', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Dick Johan', 'Initials': 'DJ', 'LastName': 'van Spronsen', 'Affiliation': 'Department of Hematology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Laurens V', 'Initials': 'LV', 'LastName': 'Beerepoot', 'Affiliation': 'Department of Internal Medicine, St. Elisabeth-Tweesteden Ziekenhuis, Tilburg, Netherlands.'}, {'ForeName': 'Maud M', 'Initials': 'MM', 'LastName': 'Geenen', 'Affiliation': 'Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.'}, {'ForeName': 'Johanneke E A', 'Initials': 'JEA', 'LastName': 'Portielje', 'Affiliation': 'Department of Internal Medicine, HAGA hospital, The Hague, Netherlands.'}, {'ForeName': 'Edwin P M', 'Initials': 'EPM', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'van Sandick', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Elma', 'Initials': 'E', 'LastName': 'Meershoek-Klein Kranenbarg', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Hanneke W M', 'Initials': 'HWM', 'LastName': 'van Laarhoven', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'van der Peet', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Cornelis J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Verheij', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Remond', 'Initials': 'R', 'LastName': 'Fijneman', 'Affiliation': 'Department of Pathology, Diagnostic Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Scharpf', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Gerrit A', 'Initials': 'GA', 'LastName': 'Meijer', 'Affiliation': 'Department of Pathology, Diagnostic Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'Cats', 'Affiliation': 'Department of Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Victor E', 'Initials': 'VE', 'LastName': 'Velculescu', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA. velculescu@jhmi.edu.'}]",Nature communications,['10.1038/s41467-020-14310-3']
3268,32126750,Continuous infusion versus intermittent bolus injection of propofol during endoscopic retrograde cholangiopancreatography.,"BACKGROUND/AIMS
It is unclear whether continuous infusion or intermittent bolus injection of propofol is better for achieving adequate sedation in endoscopic retrograde cholangiopancreatography (ERCP). We aimed to compare the efficacy and safety of continuous infusion and intermittent bolus injection of propofol during therapeutic ERCP.
METHODS
In this prospective study, we randomly assigned 232 patients undergoing therapeutic ERCP to either continuous infusion (CI group, n = 113) or intermittent bolus injection (BI group, n = 119) of propofol. The primary outcome was the quality of sedation as assessed by the endoscopist. Other sedation-related parameters included sedation induction time, total dose of propofol, recovery time, involuntary patient movement, and adverse events.
RESULTS
Overall satisfaction with sedation by the endoscopist and monitoring nurse were significantly higher in the CI group than the BI group (mean satisfaction score, 9.66 vs. 8.0 and 9.47 vs. 7.96, respectively, p < 0.01 for both). However, patients in the CI group had a significantly longer sedation induction time (5.28 minutes vs. 4.34 minutes, p < 0.01) and received a higher dose of propofol than patients in the BI group (4.22 mg/kg vs. 2.08 mg/kg, p < 0.01). There was no significant difference in adverse events between the two groups.
CONCLUSION
Continuous infusion of propofol during therapeutic ERCP had the advantage over intermittent bolus injection of maintaining a constant level of sedation without increasing adverse events. However, it was associated with an increased total dose of propofol and prolonged sedation induction time.",2020,"Results
Overall satisfaction with sedation by the endoscopist and monitoring nurse were significantly higher in the CI group than the BI group (mean satisfaction score, 9.66 vs. 8.0 and 9.47 vs. 7.96, respectively, p < 0.01 for both).",['232 patients undergoing'],"['therapeutic ERCP to either continuous infusion (CI group, n = 113) or intermittent bolus injection (BI group, n = 119) of propofol', 'propofol']","['efficacy and safety', 'sedation induction time', 'quality of sedation', 'sedation induction time, total dose of propofol, recovery time, involuntary patient movement, and adverse events', 'adverse events', 'Overall satisfaction with sedation by the endoscopist and monitoring nurse', 'total dose of propofol and prolonged sedation induction time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1301695', 'cui_str': 'Intermittent bolus (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]",232.0,0.0230448,"Results
Overall satisfaction with sedation by the endoscopist and monitoring nurse were significantly higher in the CI group than the BI group (mean satisfaction score, 9.66 vs. 8.0 and 9.47 vs. 7.96, respectively, p < 0.01 for both).","[{'ForeName': 'Jae Gon', 'Initials': 'JG', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.'}, {'ForeName': 'Kyo-Sang', 'Initials': 'KS', 'LastName': 'Yoo', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.'}, {'ForeName': 'Young Jae', 'Initials': 'YJ', 'LastName': 'Byun', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.'}]",The Korean journal of internal medicine,['10.3904/kjim.2018.233']
3269,31404466,Delivery of a Nicotine Replacement Therapy Sample at Outdoor Smoking Hotspots for Promoting Quit Attempts: A Pilot Randomized Controlled Trial.,"INTRODUCTION
Outdoor smoking hotspots are convenient venues for promoting smoking cessation. This randomized controlled trial aimed to obtain proof-of-concept evidence of the feasibility and preliminary effectiveness on quit attempts of delivering a 1-week free nicotine replacement therapy sample (NRTS) to smokers.
METHODS
This pilot parallel, single-blinded, two-group (1:1) randomized controlled trial proactively recruited adult smokers in outdoor smoking hotspots in Hong Kong. Smokers consuming at least 10 cigarettes per day and fit for NRT use were individually randomized to receive either a 1-week NRT gum/patch and brief advice lasting 10 minutes (NRTS, n = 50), or receive only brief advice (control, n = 50). The primary outcomes were any self-reported quit attempts (stop smoking for at least 24 hours) at 1- and 3-month telephone follow-up. Risk ratios from log-binomial regression models were used to assess the associations.
RESULTS
The NRTS increased quit attempts at 1-month (14% vs. 10%; adjusted risk ratio = 1.25, 95% CI = 0.43 to 3.61) and 3-month follow-up (26% vs. 12%; adjusted risk ratio = 2.17, 95% CI = 0.89 to 5.27), but the differences were not significant. Trial participation rate was about 81.3%. Around 54% of the intervention group participants used the NRT sample by the first month. The NRT users reported generally positive feedback about the usefulness of NRT sample for smoking cessation. Major factors of not using NRT included bad gum taste and their perception that NRT was not useful.
CONCLUSIONS
Delivering NRTS to smokers in outdoor smoking hotspots was feasible and efficacious in increasing NRT use. Additional post-recruitment support to sustain the use of NRT and cessation services is needed.
IMPLICATIONS
Our study supported that smokers at outdoor smoking hotspots can be approached for a brief smoking cessation intervention including an onsite delivery of NRTS. Delivering NRTS and a brief advice on using NRT to these smokers was feasible and efficacious to increase NRT use. A larger trial on the benefits on quit attempts and long-term abstinence is warranted.",2020,The NRTS increased quit attempts at 1-month (14% versus 10%; adjusted risk ratio (ARR) =,"['RCT proactively recruited adult smokers in outdoor smoking hotspots in Hong Kong', 'Smokers consuming ≥10 cigarettes per day and fit for NRT use', 'smokers', 'sample at outdoor smoking hotspots for promoting quit attempts']","['nicotine replacement therapy', 'NRT gum/patch and brief advice lasting 10 minutes (NRTS, n=50), or receive only brief advice (control', 'nicotine replacement therapy sample (NRTS', 'NRT']","['quit attempts', 'self-reported quit attempts (stop smoking', 'Risk ratios']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",,0.0640873,The NRTS increased quit attempts at 1-month (14% versus 10%; adjusted risk ratio (ARR) =,"[{'ForeName': 'Yee Tak Derek', 'Initials': 'YTD', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'William Ho', 'Initials': 'WH', 'LastName': 'Cheung Li', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, University of Hong Kong, Hong Kong, China.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz138']
3270,31685797,"Chitosan oligosaccharide (GO2KA1) improves postprandial glycemic response in subjects with impaired glucose tolerance and impaired fasting glucose and in healthy subjects: a crossover, randomized controlled trial.","BACKGROUND
The antidiabetic and hypoglycemic effects of chitosan have been reported in previous studies. We have previously shown that chitosan oligosaccharide reduces postprandial blood glucose levels in vivo. We conducted a short-term crossover study to support the results of the previous study.
METHODS
The study was a randomized, double-blind, controlled crossover trial completed at one clinical research site. Subjects with impaired glucose tolerance and impaired fasting glucose and healthy subjects were randomly assigned to consume one of two different experimental test capsules that differed in only the sample source (GO2KA1 vs placebo), and all subjects were instructed to consume the 75 g sucrose within 15 min. After a 7-day interval, the subjects consumed the other capsules that were not consumed on the first day. We assessed blood glucose levels using a 2-h oral sucrose tolerance test. The study was registered at clinicaltrials.gov (NCT03650023).
RESULTS
The test group showed significantly lower blood glucose levels at 60 min (p = 0.010) and postprandial blood glucose areas under the curve (p = 0.012). The change in blood glucose levels at 60 min was significantly lower in the test group than in the placebo group (p = 0.017).
CONCLUSIONS
Based on the results of this study, the consumption of chitosan oligosaccharide (GO2KA1) supplements with a meal can effectively reduce postprandial blood glucose levels, which is relevant to the prevention of diabetes.",2019,The test group showed significantly lower blood glucose levels at 60 min (p = 0.010) and postprandial blood glucose areas under the curve (p = 0.012).,"['Subjects with impaired glucose tolerance and impaired fasting glucose and healthy subjects', 'subjects with impaired glucose tolerance and impaired fasting glucose and in healthy subjects']","['placebo', 'chitosan oligosaccharide', 'experimental test capsules that differed in only the sample source (GO2KA1 vs placebo', 'Chitosan oligosaccharide (GO2KA1']","['blood glucose levels', 'postprandial blood glucose areas', 'postprandial blood glucose levels', 'postprandial glycemic response']","[{'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3255751', 'cui_str': 'CHITOSAN OLIGOSACCHARIDE'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C4505759', 'cui_str': 'GO2KA1'}]","[{'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",,0.127154,The test group showed significantly lower blood glucose levels at 60 min (p = 0.010) and postprandial blood glucose areas under the curve (p = 0.012).,"[{'ForeName': 'Sarang', 'Initials': 'S', 'LastName': 'Jeong', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Jung', 'Initials': 'J', 'LastName': 'Min Cho', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Young-In', 'Initials': 'YI', 'LastName': 'Kwon', 'Affiliation': 'Department of Food and Nutrition, Hannam University, Daejeon, 305-811, Korea.'}, {'ForeName': 'Seong-Chul', 'Initials': 'SC', 'LastName': 'Kim', 'Affiliation': 'Institute of Functional Foods, KunpoongBio Co. Ltd., Jeju, 63010, Korea.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Yeob Shin', 'Affiliation': 'Department of Internal Medicine, Severance Hospital, Division of Endocrinology and Metabolism, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.'}, {'ForeName': 'Jong', 'Initials': 'J', 'LastName': 'Ho Lee', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Korea. jhleeb@yonsei.ac.kr.'}]",Nutrition & diabetes,['10.1038/s41387-019-0099-4']
3271,32125536,Comparison of the balafilcon A and samfilcon A lenses on postoperative pain control and epithelial healing time after photorefractive keratectomy: a contralateral eye study.,"To compare the effects of balafilcon A and samfilcon A silicone hydrogel bandage contact lenses on postoperative pain control and epithelial healing time after photorefractive keratectomy (PRK). Seventy-four eyes of 37 patients who underwent bilateral PRK were included in this randomized clinical trial study. In the end of the surgery, a balafilcon A lens was used in one eye and a samfilcon A lens was used in the fellow eye randomly. Pain, blurred vision, epiphora, photophobia, and foreign body sensation were assessed on the first and third postoperative day using a visual analogue scale (0 = no ocular pain or discomfort, 10 = highest level of ocular pain and discomfort). For balafilcon A and samfilcon A lenses, mean scores for pain were 6.22 ± 2.81 and 3.11 ± 2.90 on first postoperative day (p < 0.001) and 1.57 ± 1.65 and 0.68 ± 0.85 on third postoperative day (p = 0.001), respectively; mean scores for foreign body sensation were 6.11 ± 2.53 and 3.19 ± 2.72 on first postoperative day (p < 0.001) and 3.16 ± 1.92 and 1.35 ± 1.43 on third postoperative day (p < 0.001), also respectively; and mean scores for epiphora were 6.46 ± 2.64 and 5.46 ± 3.40 on first postoperative day (p = 0.007) and 1.68 ± 1.60 and 1.32 ± 1.31 on third postoperative day (p = 0.065), again respectively. No significant difference in blurred vision or photophobia emerged between the lenses on first and third postoperative day after PRK. On the third postoperative day, reepithelialization was complete in 83.7% of eyes with the balafilcon A lens and 89.1% of eyes fitted with the samfilcon A lens. Wearing samfilcon A lenses after photorefractive keratectomy can significantly manage pain, decrease foreign body sensation on first and third postoperative day, and reduce epiphora on first postoperative day.",2020,No significant difference in blurred vision or photophobia emerged between the lenses on first and third postoperative day after PRK.,"['after photorefractive keratectomy (PRK', 'after photorefractive keratectomy', 'Seventy-four eyes of 37 patients who underwent bilateral PRK']","['balafilcon A and samfilcon A silicone hydrogel bandage contact lenses', 'balafilcon A and samfilcon A lenses']","['mean scores for pain', 'mean scores for foreign body sensation', 'Pain, blurred vision, epiphora, photophobia, and foreign body sensation', 'manage pain, decrease foreign body sensation', 'postoperative pain control and epithelial healing time', 'ocular pain and discomfort', 'blurred vision or photophobia']","[{'cui': 'C0395416', 'cui_str': 'Photorefractive Keratectomy'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C2002496', 'cui_str': 'balafilcon A'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C1449669', 'cui_str': 'Bandages, Hydrogel'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation (finding)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0152227', 'cui_str': 'Epiphora'}, {'cui': 'C0085636', 'cui_str': 'Light Sensitivity'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0151827', 'cui_str': 'Eye pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}]",,0.0463935,No significant difference in blurred vision or photophobia emerged between the lenses on first and third postoperative day after PRK.,"[{'ForeName': 'Necati', 'Initials': 'N', 'LastName': 'Duru', 'Affiliation': 'Department of Ophthalmology, Kayseri City Education and Research Hospital, Kayseri, Turkey. necatiduru@gmail.com.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Altunel', 'Affiliation': 'Department of Ophthalmology, Kayseri City Education and Research Hospital, Kayseri, Turkey.'}, {'ForeName': 'Ender', 'Initials': 'E', 'LastName': 'Sırakaya', 'Affiliation': 'Department of Ophthalmology, Kayseri City Education and Research Hospital, Kayseri, Turkey.'}, {'ForeName': 'Bekir', 'Initials': 'B', 'LastName': 'Küçük', 'Affiliation': 'Department of Ophthalmology, Kayseri City Education and Research Hospital, Kayseri, Turkey.'}]",Lasers in medical science,['10.1007/s10103-020-02985-5']
3272,31628428,Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study.,"RESONATE-2 is a phase 3 study of first-line ibrutinib versus chlorambucil in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Patients aged ≥65 years (n = 269) were randomized 1:1 to once-daily ibrutinib 420 mg continuously or chlorambucil 0.5-0.8 mg/kg for ≤12 cycles. With a median (range) follow-up of 60 months (0.1-66), progression-free survival (PFS) and overall survival (OS) benefits for ibrutinib versus chlorambucil were sustained (PFS estimates at 5 years: 70% vs 12%; HR [95% CI]: 0.146 [0.098-0.218]; OS estimates at 5 years: 83% vs 68%; HR [95% CI]: 0.450 [0.266-0.761]). Ibrutinib benefit was also consistent in patients with high prognostic risk (TP53 mutation, 11q deletion, and/or unmutated IGHV) (PFS: HR [95% CI]: 0.083 [0.047-0.145]; OS: HR [95% CI]: 0.366 [0.181-0.736]). Investigator-assessed overall response rate was 92% with ibrutinib (complete response, 30%; 11% at primary analysis). Common grade ≥3 adverse events (AEs) included neutropenia (13%), pneumonia (12%), hypertension (8%), anemia (7%), and hyponatremia (6%); occurrence of most events as well as discontinuations due to AEs decreased over time. Fifty-eight percent of patients continue to receive ibrutinib. Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.",2020,Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.,"['patients with CLL/SLL', 'chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL', 'Patients aged ≥65 years (n\u2009=\u2009269']","['daily ibrutinib 420\u2009mg continuously or chlorambucil 0.5-0.8\u2009mg/kg for ≤12 cycles', 'first-line ibrutinib treatment', 'chlorambucil']","['hyponatremia', 'Investigator-assessed overall response rate', 'progression-free survival (PFS) and overall survival (OS) benefits', 'anemia', 'pneumonia', 'neutropenia', 'hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0024303', 'cui_str': 'Lymphocytic lymphoma'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4555385', 'cui_str': 'Ibrutinib 420 MG'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",,0.152562,Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.,"[{'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Burger', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA. jaburger@mdanderson.org.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Barr', 'Affiliation': 'Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Owen', 'Affiliation': 'Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tedeschi', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Osnat', 'Initials': 'O', 'LastName': 'Bairey', 'Affiliation': 'Rabin Medical Center, Petah Tikva, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': 'The Leeds Teaching Hospitals, St. James Institute of Oncology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': 'Stanford Cancer Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Devereux', 'Affiliation': 'Kings College Hospital, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Hematology and Cancer Prevention, Silesiam Medical University, Katowice, Poland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Royal Bournemouth General Hospital, Bournemouth, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Universitair Ziekenhuis Gent, Gent, Belgium.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Dai', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Lal', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dean', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': 'UCSD Moores Cancer Center, San Diego, CA, USA.'}]",Leukemia,['10.1038/s41375-019-0602-x']
3273,31387766,A randomized controlled trial of public messaging to promote safe firearm storage among U.S. military veterans.,"BACKGROUND
The objectives of this study were to determine whether short-term exposure to firearm safety messaging significantly improved (1) firearm storage practices, and (2) attitudes of safe firearm storage behaviors among U.S. veterans, a group at elevated risk for firearm suicide.
DESIGN
A three-arm, parallel-group RCT was conducted online in the U.S. nationwide from December 2015 to January 2016.
SETTING
A national random sample of U.S. veterans (N = 358) was recruited from the GfK KnowledgePanel, a probability-based internet panel representative of U.S. adults. All study activities were administered online over a three-week study period.
INTERVENTION
Participants were randomized and exposed three times (once per week) to either (a) firearm safety message only (n = 115); (b) firearm safety and mental health promotion messages (n = 133); or (c) active control group exposed to mental health promotion message only (n = 110). Each message was less than two minutes long.
MEASURES
Assessments were completed at baseline (pre-randomization) and at end-of-trial. Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys. Linear mixed effect models with weighted generalized estimating equations were used to test for exposure effects. Analyses were conducted February 2018.
RESULTS
Analyses restricted to those with baseline firearm access (n = 195) identified no significant changes for intentions or safe storage practices across exposure groups. At baseline, participants' attitudes and beliefs were generally supportive of safe firearm storage. The Firearm Safety message yielded small increases in agreement with the concept that secure storage is ""important during emotional or stressful times"" (0.36; 95% CI = 0.08, 0.64). Other significant changes in awareness and beliefs were found, but across all study conditions.
CONCLUSION
Results reinforce the critical need for considerable research and testing prior to the widespread implementation of public messages to increase the likelihood for desired exposure effects.",2019,"Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys.","['U.S. military veterans', 'U.S. veterans, a group at elevated risk for firearm suicide', 'A national random sample of U.S. veterans (N\u202f=\u202f358) was recruited from the GfK KnowledgePanel, a probability-based internet panel representative of U.S. adults']","['public messaging', 'firearm safety message only (n\u202f=\u202f115); (b) firearm safety and mental health promotion messages (n\u202f=\u202f133); or (c) active control group exposed to mental health promotion message']","['awareness and beliefs', 'intentions or safe storage practices', 'awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0016139', 'cui_str': 'Firearms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0016139', 'cui_str': 'Firearms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.0646168,"Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Karras', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Department of Psychiatry, University of Rochester, Rochester, NY, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA. Electronic address: Elizabeth.Karras@va.gov.'}, {'ForeName': 'Cara M', 'Initials': 'CM', 'LastName': 'Stokes', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Warfield', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Shannon K', 'Initials': 'SK', 'LastName': 'Barth', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Bossarte', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA; Department of Behavioral Medicine and Psychiatry, School of Medicine, West Virginia University, Morgantown, WV, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.03.001']
3274,32065006,Tetrahydrocannabinol and cannabidiol oromucosal spray in resistant multiple sclerosis spasticity: consistency of response across subgroups from the SAVANT randomized clinical trial.,"Objective: To determine whether differences in disability status, spasticity severity, and spasticity duration at treatment start in patients with resistant multiple sclerosis (MS) spasticity might influence response to add-on tetrahydrocannabinol:cannabidiol (THC:CBD) oromucosal spray (nabiximols) versus further re-adjustment of optimized first-line antispasticity medication. Methods: Using the database from the Sativex ® as Add-on therapy Vs. further optimized first-line ANTispastics (SAVANT) study, this post hoc analysis evaluated spasticity severity (0-10 numerical rating scale [NRS] scores) and pain severity (0-10 NRS scores) evolution from randomization (baseline) to week 12 (end of double-blind treatment) in defined subgroups: Expanded disability status scale [EDSS] score subgroups (<6 and ≥6); spasticity severity 0-10 NRS score subgroups (4 to ≤6 and >6), and spasticity duration subgroups (<5 and ≥5 years). Results: THC:CBD oromucosal spray (nabiximols) halved mean severity scores for spasticity and pain in all subgroups. Active treatment significantly improved mean spasticity severity scores versus placebo from week 4 onwards in both EDSS subgroups, in the severe spasticity subgroup, and in both spasticity duration subgroups. Active treatment significantly improved mean pain severity scores versus placebo in the ≥6 EDSS subgroup, in the severe spasticity subgroup and in both spasticity duration subgroups. Conclusion: Add-on THC:CBD oromucosal spray (nabiximols) consistently relieves resistant spasticity across subgroups defined by baseline EDSS score, spasticity severity NRS score and spasticity duration. Patients with moderate resistant MS spasticity benefit numerically from treatment; patients with severe resistant spasticity achieve significant therapeutic gains. Spasticity-associated pain often improves similarly in the same subgroups.",2020,"Active treatment significantly improved mean spasticity severity scores versus placebo from week 4 onwards in both EDSS subgroups, in the severe spasticity subgroup, and in both spasticity duration subgroups.","['patients with resistant multiple sclerosis (MS) spasticity', 'subgroups (< 6 and ≥6); spasticity severity 0-10 NRS score subgroups (4 to ≤6 and >6), and spasticity duration subgroups (< 5 and ≥5 years']","['placebo', 'Tetrahydrocannabinol and cannabidiol oromucosal spray', 'THC:CBD oromucosal spray (nabiximols', 'tetrahydrocannabinol:cannabidiol (THC:CBD) oromucosal spray (nabiximols']","['Spasticity-associated pain', 'mean pain severity scores', 'mean spasticity severity scores', 'Disability Status Scale [EDSS] score', 'disability status, spasticity severity, and spasticity duration', 'spasticity severity (0-10 Numerical Rating Scale [NRS] scores) and pain severity (0-10 NRS scores) evolution from randomization (baseline']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C1273657', 'cui_str': 'Oromucosal spray'}, {'cui': 'C2347556', 'cui_str': 'tetrahydrocannabinol-cannabidiol combination'}]","[{'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",,0.065772,"Active treatment significantly improved mean spasticity severity scores versus placebo from week 4 onwards in both EDSS subgroups, in the severe spasticity subgroup, and in both spasticity duration subgroups.","[{'ForeName': 'Sven G', 'Initials': 'SG', 'LastName': 'Meuth', 'Affiliation': 'Department of Neurology with Institute of Translational Neurology, University Hospital Munster, Munster, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Henze', 'Affiliation': 'Praxis Für Neurologie, Regensburg, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Essner', 'Affiliation': 'O. Meany Consultancy GmbH, Hamburg, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Trompke', 'Affiliation': 'R&D, Almirall Hermal GmbH, Reinbek, Germany.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Vila Silván', 'Affiliation': 'Global Medical Affairs, Almirall S.A, Barcelona, Spain.'}]",The International journal of neuroscience,['10.1080/00207454.2020.1730832']
3275,32105198,Virtual Microscopy Is More Effective Than Conventional Microscopy for Teaching Cytology to Veterinary Students: A Randomized Controlled Trial.,"Virtual microscopy (VM) using scanned slides and imaging software is increasingly used in medical curricula alongside instruction in conventional microscopy (CM). Limited reports suggest that VM is useful in the veterinary education setting, and generally well-received by students. Whether students can apply knowledge gained through VM to practical use is unknown. Our objective was to determine whether instruction using VM, compared to CM, is a successful method of training veterinary students for the application of cytology in practice (i.e., using light microscopes). Seventy-one veterinary students from Colorado State University who attended a voluntary 3-hour cytology workshop were randomized to receive the same instruction with either VM ( n = 35) or CM ( n = 36). We compared these students to a control group ( n = 22) of students who did not attend a workshop. All students took a post-workshop assessment involving the interpretation of four cases on glass slides with CM, designed to simulate the use of cytology in general practice. Students also took an 18-question survey related to the effectiveness of the workshop, providing their opinions on cytology instruction in the curriculum and their learning preference (VM or CM). The mean assessment score of the VM group (14.18 points) was significantly higher than the control group (11.33 points, p = .003), whereas the mean of the CM group (12.77 points) was not statistically significantly different from controls ( p = .170). Not only is VM an effective method of teaching cytology to veterinary students that can be translated to a real-world case scenario, but it outperformed CM instruction in this study.",2020,"The mean assessment score of the VM group (14.18 points) was significantly higher than the control group (11.33 points, ","['Seventy-one veterinary students from Colorado State University who attended a voluntary 3-hour cytology workshop', 'students to a control group ( n = 22) of students who did not attend a workshop', 'Teaching Cytology to Veterinary Students']","['Virtual microscopy (VM) using scanned slides and imaging software', 'same instruction with either VM ( n = 35) or CM']",['mean assessment score'],"[{'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559294', 'cui_str': 'Not attended'}]","[{'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0441633'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",71.0,0.0366819,"The mean assessment score of the VM group (14.18 points) was significantly higher than the control group (11.33 points, ","[{'ForeName': 'Samantha J M', 'Initials': 'SJM', 'LastName': 'Evans', 'Affiliation': 'Department of Microbiology, Immunology, and Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University.'}, {'ForeName': 'A Russell', 'Initials': 'AR', 'LastName': 'Moore', 'Affiliation': 'Department of Microbiology, Immunology, and Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University.'}, {'ForeName': 'Christine S', 'Initials': 'CS', 'LastName': 'Olver', 'Affiliation': 'Department of Microbiology, Immunology, and Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Avery', 'Affiliation': 'Department of Microbiology, Immunology, and Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'West', 'Affiliation': 'Director of the Academy for Teaching and Learning, College of Veterinary Medicine and Biomedical Sciences, Colorado State University.'}]",Journal of veterinary medical education,['10.3138/jvme.0318-029r1']
3276,32105112,Bidirectional relationship of posttraumatic stress disorder (PTSD) symptom severity and alcohol use over the course of integrated treatment.,"Posttraumatic stress disorder (PTSD) and alcohol use disorder commonly co-occur. Little is known about how symptoms of one affect subsequent week symptoms of the other during the course of integrated treatment for both disorders. The sample included 107 veterans who were randomized to receive either Concurrent Treatment of PTSD and Substance Use Disorder Using Prolonged Exposure (COPE; an exposure-based trauma focused treatment) or Seeking Safety (SS; a present-focused coping skills-based treatment) and completed measures of PTSD and alcohol use at every other session. Multilevel models estimated the prospective associations between PTSD and alcohol use during treatment. Results indicated that greater PTSD symptom severity was associated with greater future alcohol use ( b = 0.20, p = .024), and greater alcohol use was associated with greater future PTSD symptom severity ( b = 0.13, p = .003). The effect size for PTSD symptoms to future alcohol use was larger than the reciprocal relationship. When using lagged PTSD severity to predict future drinking, results revealed that clinically significant differences in PTSD severity levels were associated with comparably large differences in drinking. Treatment condition did not moderate the effect of PTSD symptom severity on alcohol use (or the reciprocal relationship). Findings lend support to the mutual maintenance model of addiction. Integrated treatments that treat both PTSD and alcohol use may be preferential to sequential model of care where individuals are expected to achieve abstinence or reduced use prior to receiving trauma-focused treatment. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Treatment condition did not moderate the effect of PTSD symptom severity on alcohol use (or the reciprocal relationship).,['107 veterans'],['Concurrent Treatment of PTSD and Substance Use Disorder Using Prolonged Exposure (COPE; an exposure-based trauma focused treatment) or Seeking Safety (SS; a present-focused coping skills-based treatment) and completed measures of PTSD and alcohol use at every other session'],"['future PTSD symptom severity', 'PTSD severity levels', 'PTSD symptom severity']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]","[{'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.00657575,Treatment condition did not moderate the effect of PTSD symptom severity on alcohol use (or the reciprocal relationship).,"[{'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Tripp', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Worley', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Straus', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Abigail C', 'Initials': 'AC', 'LastName': 'Angkaw', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Trim', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'School of Medicine.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000564']
3277,32032809,Hysteroscopic Assessment of Tubal Patency: A Randomized Comparison between the Flow and Parryscope Techniques.,"STUDY OBJECTIVE
To evaluate the accuracy of the ""Parryscope"" and ""flow"" techniques for hysteroscopic assessment of tubal patency.
DESIGN
Prospective randomized clinical trial.
SETTING
From May to October 2019, women with subfertility undergoing laparoscopic and hysteroscopic surgery at the Medical University of Vienna were invited to participate in the study. The primary outcome was accuracy of Fallopian tube patency relative to the gold standard of laparoscopic chromopertubation.
PATIENTS
Sixty women with subfertility.
INTERVENTIONS
Hysteroscopy with either the ""Parryscope"" or the ""flow"" techniques for tubal assessment, directly followed by laparoscopy with chromopertubation.
MEASUREMENTS AND MAIN RESULTS
Hysteroscopic prediction of fallopian tube patency was possible in a statistically significant manner in both study groups (p <0.05). The Parryscope technique achieved higher sensitivity (90.6%, 95% CI: 61.7-98.4) and specificity (100%, 95% CI: 90.0-100.0) than the flow technique (sensitivity: 73.7%, 95% CI: 48.8-90.9 and specificity: 70.7%, 95% CI: 54.5-83.9).
CONCLUSION
Using the Parryscope technique to determine if air bubbles traverse the ostia can provide valuable additional information during hysteroscopy and is more accurate in predicting fallopian tubal occlusion than the flow method.",2020,Hysteroscopic prediction of Fallopian tube patency was possible in a statistically significant manner in both study groups (p< 0.05).,"['60 subfertile women', 'From May to October, 2019, subfertile women undergoing laparoscopic and hysteroscopic surgery at the Medical University of Vienna were invited to participate in the study']","['Hysteroscopy with either the ""Parryscope®"" or the ""flow"" techniques', 'Parryscope®"" and ""flow"" techniques']","['Fallopian tubal occlusion', 'Hysteroscopic Assessment of tubal patency', 'higher sensitivity', 'Hysteroscopic prediction of Fallopian tube patency', 'accuracy of Fallopian tube patency relative to the gold standard of laparoscopic chromopertubation', 'specificity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0751614', 'cui_str': 'Hysteroscopic Surgical Procedures'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0020710', 'cui_str': 'Uterine Endoscopy'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0041275', 'cui_str': 'Tubal Occlusion'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3160762', 'cui_str': 'Chromopertubation'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",,0.0788059,Hysteroscopic prediction of Fallopian tube patency was possible in a statistically significant manner in both study groups (p< 0.05).,"[{'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Hager', 'Affiliation': 'Clinical Division of Gynecological Endocrinology and Reproductive Medicine (Drs. Hager, Ott, Holzer, and Kurz).'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Ott', 'Affiliation': 'Clinical Division of Gynecological Endocrinology and Reproductive Medicine (Drs. Hager, Ott, Holzer, and Kurz). Electronic address: johannes.ott@meduniwien.ac.at.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Holzer', 'Affiliation': 'Clinical Division of Gynecological Endocrinology and Reproductive Medicine (Drs. Hager, Ott, Holzer, and Kurz).'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Seemann', 'Affiliation': 'Department of Oral and Maxillofacial Surgery (Dr. Seemann), Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Kurz', 'Affiliation': 'Clinical Division of Gynecological Endocrinology and Reproductive Medicine (Drs. Hager, Ott, Holzer, and Kurz).'}, {'ForeName': 'John Preston', 'Initials': 'JP', 'LastName': 'Parry', 'Affiliation': 'Parryscope and Positive Steps Fertility, Madison; Department of Obstetrics and Gynecology, University of Mississippi Medical Center (Dr. Parry), Jackson, Mississippi.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.01.014']
3278,32086878,Changes in kidney function among men having sex with men starting on demand tenofovir disoproxil fumarate - emtricitabine for HIV pre-exposure prophylaxis.,"INTRODUCTION
Daily pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is associated with a small but statistically significant decrease in estimated glomerular filtration rate (eGFR). We assessed the renal safety of on-demand PrEP with TDF/FTC in HIV-1 uninfected men.
METHODS
We used data from the randomized double-blind placebo-controlled ANRS-IPERGAY trial and its open-label extension conducted between February 2012 and June 2016 among HIV-uninfected MSM starting on-demand PrEP. Using linear mixed model, we evaluated the mean eGFR decline from baseline over time and determined risks factors associated with eGFR decline during the study.
RESULTS
During the blind phase, with a median follow-up of 9.4 months, the mean decline slope of eGFR from baseline was -0.88 and -1.53 mL/min/1.73 m 2 per year in the placebo (n = 201) and the TDF/FTC group (n = 198) respectively, with a slope difference of 0.65 mL/min/1.73 m 2 per year (p = 0.27). Including both phases, 389 participants started on-demand TDF/FTC with a median follow-up of 19.2 months and a mean decline of eGFR from baseline of -1.14 mL/min/1.73 m 2 per year (p < 0.001). The slope of eGFR reduction was not significantly different in participants with baseline eGFR ≤ 90 mL/min/1.73 m 2 (p = 0.44), age >40 years (p = 0.24) or hypertension (p = 0.21). There was a dose-response relationship between recent tenofovir exposure and lower eGFR when considering the number of pills taken in the two months prior the visit (eGFR difference of -0.88 mL/min/1.73 m 2 between >15 pills/month vs. ≤15 pills/month, p < 0.01) or plasma tenofovir concentrations at the visit (eGFR difference compared to ≤2 ng/mL: >2 to ≤10ng/mL: -0.98 mL/min/1.73 m 2 , >10 to ≤40ng/mL: -1.28 mL/min/1.73 m 2 , >40 ng/mL: -1.82 mL/min/1.73 m 2 , p < 0.001). Three participants discontinued TDF/FTC for eGFR < 60 mL/min/1.73 m 2 during the OLE phase. No case of Fanconi syndrome was reported.
CONCLUSIONS
The renal safety of on-demand PrEP with TDF/FTC was good. The overall reduction and intermittent exposure to TDF/FTC may explain this good renal safety.",2020,The slope of eGFR reduction was not significantly different in participants with baseline eGFR ≤ 90 mL,"['group (n\xa0=\xa0198', 'February 2012 and June 2016 among HIV-uninfected MSM starting on-demand PrEP', 'men having sex with men starting on demand', '40', 'HIV-1 uninfected men']","['tenofovir disoproxil fumarate - emtricitabine', 'tenofovir disoproxil fumarate/emtricitabine (TDF/FTC', 'placebo', 'mL', 'Daily pre-exposure prophylaxis (PrEP', 'ng/mL', 'TDF/FTC']","['mean eGFR decline', 'kidney function', 'renal safety', 'Fanconi syndrome', 'slope of eGFR reduction', 'estimated glomerular filtration rate (eGFR', 'plasma tenofovir concentrations']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015624', 'cui_str': 'Proximal Renal Tubular Dysfunction'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3811844'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.29567,The slope of eGFR reduction was not significantly different in participants with baseline eGFR ≤ 90 mL,"[{'ForeName': 'Geoffroy', 'Initials': 'G', 'LastName': 'Liegeon', 'Affiliation': 'Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Guillemette', 'Initials': 'G', 'LastName': 'Antoni', 'Affiliation': 'INSERM, Villejuif, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Pialoux', 'Affiliation': 'Hôpital Tenon, Paris, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Capitant', 'Affiliation': 'INSERM, Villejuif, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Cotte', 'Affiliation': 'Hôpital de la Croix Rousse, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Charreau', 'Affiliation': 'INSERM, Villejuif, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Tremblay', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montréal, Canada.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cua', 'Affiliation': ""Hôpital de l'Archet, Nice, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Senneville', 'Affiliation': 'Hôpital G. Dron, Centre Hospitalier Universitaire de Tourcoing, Tourcoing, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Raffi', 'Affiliation': 'INSERM UIC 143 Nantes University, Nantes, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'INSERM, Villejuif, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25420']
3279,32089371,"Metabolic rate in sedentary adults, following different exercise training interventions: The FIT-AGEING randomized controlled trial.","BACKGROUND & AIMS
This study compares the influence of different exercise training programs on basal metabolic rate (BMR) and fat oxidation, in basal conditions (BFox) and during exercise (MFO), in sedentary, middle-aged adults.
METHODS
The study subjects of this 12 week-long, randomised controlled trial, were 71 middle-aged adults (age 53.5 ± 4.9 years; 52% women). Subjects were randomly assigned to one of the following groups: (1) no exercise, (2) concurrent training based on international physical activity recommendations (PAR group), (3) high intensity interval training (HIIT group), and (4) high intensity interval training plus whole-body electromyostimulation (HIIT + EMS group). Subject BMR, BFox and MFO were determined by indirect calorimetry before and after the intervention.
RESULTS
The HIIT + EMS subjects showed significant increases in BFox following the intervention compared with the control group (all P = 0.043); no such differences were seen in the PAR and HIIT compared with the control group (all P ≥ 0.1). A significant increase in post-intervention MFO was noted for the HIIT and HIIT + EMS group compared to the non-exercise control group (P < 0.05); no such difference was seen in the PAR group compared to the control group (all P ≥ 0.05).
CONCLUSIONS
Twelve weeks of high intensity interval training plus whole-body electromyostimulation may increase the BFox and MFO of middle-aged sedentary adults. These findings have important clinical implications; a well-designed high-intensity interval training program plus whole-body electromyostimulation might be followed to help combat the appearance of chronic metabolic diseases characterized by metabolic inflexibility in middle-aged sedentary adults, though it will be necessary to determine how long the effects last.",2020,"A significant increase in post-intervention MFO was noted for the HIIT and HIIT + EMS group compared to the non-exercise control group (P < 0.05); no such difference was seen in the PAR group compared to the control group (all P ≥ 0.05).
","['71 middle-aged adults (age 53.5\xa0±\xa04.9 years; 52% women', 'sedentary, middle-aged adults', 'sedentary adults', 'middle-aged sedentary adults']","['exercise training programs', 'interval training plus whole-body electromyostimulation', 'no exercise, (2) concurrent training based on international physical activity recommendations (PAR group), (3) high intensity interval training (HIIT group), and (4) high intensity interval training plus whole-body electromyostimulation (HIIT\xa0+\xa0EMS group', 'exercise training interventions']","['post-intervention MFO', 'BFox', 'basal metabolic rate (BMR) and fat oxidation, in basal conditions (BFox) and during exercise (MFO', 'Metabolic rate', 'BFox and MFO', 'Subject BMR, BFox and MFO']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0678121', 'cui_str': 'Basal metabolic rate (observable entity)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}]",71.0,0.0385147,"A significant increase in post-intervention MFO was noted for the HIIT and HIIT + EMS group compared to the non-exercise control group (P < 0.05); no such difference was seen in the PAR group compared to the control group (all P ≥ 0.05).
","[{'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Amaro-Gahete', 'Affiliation': 'EFFECTS-262 Research Group, Department of Medical Physiology, School of Medicine, University of Granada, Spain; PROmoting FITness and Health Through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Spain. Electronic address: amarof@ugr.es.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'De-la-O', 'Affiliation': 'EFFECTS-262 Research Group, Department of Medical Physiology, School of Medicine, University of Granada, Spain.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Jurado-Fasoli', 'Affiliation': 'EFFECTS-262 Research Group, Department of Medical Physiology, School of Medicine, University of Granada, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Sanchez-Delgado', 'Affiliation': 'PROmoting FITness and Health Through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Spain; Pennington Biomedical Research Center, LA USA.'}, {'ForeName': 'Jonatan R', 'Initials': 'JR', 'LastName': 'Ruiz', 'Affiliation': 'PROmoting FITness and Health Through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Spain.'}, {'ForeName': 'Manuel J', 'Initials': 'MJ', 'LastName': 'Castillo', 'Affiliation': 'EFFECTS-262 Research Group, Department of Medical Physiology, School of Medicine, University of Granada, Spain.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.02.001']
3280,31974857,Alterations in energy system contribution following upper body sprint interval training.,"PURPOSE
The primary purpose of this study was to examine the influence of different work-to-rest ratios on relative energy system utilization during short-term upper-body sprint interval training (SIT) protocols.
METHODS
Forty-two recreationally trained men were randomized into one of three training groups [10 s work bouts with 2 min of rest (10:2, n = 11) or 4 min of rest (10:4, n = 11), or 30 s work bouts with 4 min of rest (30:4, n = 10)] or a control group (CON, n = 10). Participants underwent six training sessions over 2 weeks with 4-6 'all-out' sprints. Participants completed an upper body Wingate test (30 s 'all-out' using 0.05 kg kg -1 of the participant's body mass) pre- and post-intervention from which oxygen consumption and blood lactate were used to estimate oxidative, glycolytic, and adenosine triphosphate-phosphocreatine (ATP-PCr) energy system provisions. An analysis of covariance was performed on all testing measurements collected at post with the associated pre-values used as covariates.
RESULTS
Relative energy contribution (p = 0.026) and energy expenditure (p = 0.019) of the ATP-PCr energy system were greater in 10:4 (49.9%; 62.1 kJ) compared to CON (43.1%; 47.2 kJ) post training. No significant differences were found between groups in glycolytic or oxidative energy contribution over a 30 s upper body Wingate test.
CONCLUSION
SIT protocols with smaller work-to-rest ratios may enhance ATP-PCr utilization in a 30 s upper body Wingate over a 2-week intervention.",2020,"No significant differences were found between groups in glycolytic or oxidative energy contribution over a 30 s upper body Wingate test.
",['Forty-two recreationally trained men'],['short-term upper-body sprint interval training (SIT'],"['energy expenditure', 'ATP-PCr energy system', 'glycolytic or oxidative energy contribution']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}]","[{'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",42.0,0.020372,"No significant differences were found between groups in glycolytic or oxidative energy contribution over a 30 s upper body Wingate test.
","[{'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'La Monica', 'Affiliation': 'Department of Kinesiology, Missouri State University, 901 S National Ave, Springfield, MO, 65897, USA. MichaelLaMonica@MissouriState.edu.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Fukuda', 'Affiliation': 'Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, 4000 Central Florida Blvd, Orlando, FL, 32816, USA.'}, {'ForeName': 'Tristan M', 'Initials': 'TM', 'LastName': 'Starling-Smith', 'Affiliation': 'Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, 4000 Central Florida Blvd, Orlando, FL, 32816, USA.'}, {'ForeName': 'Nicolas W', 'Initials': 'NW', 'LastName': 'Clark', 'Affiliation': 'Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, 4000 Central Florida Blvd, Orlando, FL, 32816, USA.'}, {'ForeName': 'Valeria L G', 'Initials': 'VLG', 'LastName': 'Panissa', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}]",European journal of applied physiology,['10.1007/s00421-020-04304-w']
3281,31989240,Acute and daily effects of repeated voluntary hyperpnea on pulmonary function in healthy adults.,"PURPOSE
Hyperpnea training has been used as a method for both improving exercise performance in healthy persons and improving ventilatory capacity in patients with pulmonary disease. However, voluntary hyperpnea causes acute declines in pulmonary function, but the effects of repeated days of hyperpnea on airway function are not known. The purpose of this study was to determine the effects of repeated normocapnic hyperpnea on daily and post-hyperpnea pulmonary function in healthy adults.
METHODS
Ten healthy adults (21 years; 170 cm; 66 kg) completed ten hyperpnea training sessions within 17-days (TR). Training sessions consisted of 20-minutes of normocapnic hyperpnea with gradually increased minute ventilation over the 10 days. Spirometry was assessed at baseline and serially following hyperpnea during each experimental day. A control group (24 years; 171 cm; 66 kg) completed 10 days of spirometry with no hyperpnea training (CON).
RESULTS
In both CON and TR subjects, baseline pulmonary function was unchanged during the 10 days. In TR subjects, pulmonary function was decreased at 5 mins after hyperpnea but thereafter increased to pre-hyperpnea values by 30 mins. Furthermore, these changes in pulmonary function were consistent during the 10 training days. In TR subjects, maximal voluntary ventilation decreased by 10.4 ± 8.9% (168-150 L min -1 ) over the 10 days (P < 0.05), whereas it was unchanged in CON subjects.
CONCLUSIONS
These findings demonstrate that voluntary hyperpnea acutely decreases airway function in healthy subjects. However, there does not appear to be a cumulative effect of repeated hyperpnea, as daily pulmonary function was unchanged.",2020,"In TR subjects, maximal voluntary ventilation decreased by 10.4 ± 8.9% (168-150 L min -1 ) over the 10 days (P < 0.05), whereas it was unchanged in CON subjects.
","['healthy adults', 'healthy persons', 'patients with pulmonary disease', 'healthy subjects', 'Ten healthy adults (21\xa0years; 170\xa0cm; 66\xa0kg) completed ten']","['repeated voluntary hyperpnea', 'repeated normocapnic hyperpnea', 'Hyperpnea training', 'spirometry with no hyperpnea training (CON', 'voluntary hyperpnea', 'hyperpnea training sessions within 17-days (TR']","['minute ventilation', 'maximal voluntary ventilation', 'exercise performance', 'pulmonary function', 'baseline pulmonary function', 'airway function']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0220854', 'cui_str': 'Hyperpnea (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C1384388', 'cui_str': 'Maximum breathing capacity, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",10.0,0.0236597,"In TR subjects, maximal voluntary ventilation decreased by 10.4 ± 8.9% (168-150 L min -1 ) over the 10 days (P < 0.05), whereas it was unchanged in CON subjects.
","[{'ForeName': 'Eden', 'Initials': 'E', 'LastName': 'Towers', 'Affiliation': 'Department of Environmental and Health Sciences, Northern Vermont University-Johnson, 337 College Hill Road, Johnson, VT, 05405, USA.'}, {'ForeName': 'Adriane', 'Initials': 'A', 'LastName': 'Morrison-Taylor', 'Affiliation': 'Department of Environmental and Health Sciences, Northern Vermont University-Johnson, 337 College Hill Road, Johnson, VT, 05405, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Demar', 'Affiliation': 'Department of Environmental and Health Sciences, Northern Vermont University-Johnson, 337 College Hill Road, Johnson, VT, 05405, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Klansky', 'Affiliation': 'Department of Environmental and Health Sciences, Northern Vermont University-Johnson, 337 College Hill Road, Johnson, VT, 05405, USA.'}, {'ForeName': 'Kasie', 'Initials': 'K', 'LastName': 'Craig', 'Affiliation': 'Department of Environmental and Health Sciences, Northern Vermont University-Johnson, 337 College Hill Road, Johnson, VT, 05405, USA.'}, {'ForeName': 'Hans Christian', 'Initials': 'HC', 'LastName': 'Haverkamp', 'Affiliation': 'Department of Nutrition and Exercise Physiology, Elson S. Floyd College of Medicine, Washington State University, PO Box 1495, Spokane, WA, 99210-1495, USA. hans.haverkamp@wsu.edu.'}]",European journal of applied physiology,['10.1007/s00421-020-04302-y']
3282,31389909,Effects of Exercise Training and Statin Use in People Living with HIV with Dyslipidemia.,"PURPOSE
To evaluate the effects of the combination of ET and statins in people living with HIV.
METHODS
This was a randomized, double-blind, placebo-controlled clinical trial. Eighty-three people living with HIV were assigned to either placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET) groups. Volunteers assigned to STA and STAET groups were administered 10 mg of rosuvastatin, whereas the PL and PLET groups were administered a placebo. PLET and STAET groups performed ET three times a week. Before and after the 12-week follow-up, the volunteers underwent to anthropometric assessment and blood collection to evaluate lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests were performed.
RESULTS
There was a decrease in total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT) in the STA, PLET, and STAET groups compared to PL group (p<0.001). Furthermore, there was a decrease in TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels in the STAET groups compared to the STA (p<0.001) and PLET groups (p<0.001). There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001). The PLET and STAET groups reduced body fat mass, body fat percentage and increased lean body mass, MS and CF compared to PL (p<0.001) and STA (p<0.001) groups.
CONCLUSION
The combination of ET and statins is useful to enhance lipid and inflammatory profiles, reduce CVD markers, and improve Doppler ultrasound findings, MS and CF in people living with HIV.",2019,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","['people living with HIV', 'People Living with HIV with Dyslipidemia', 'Eighty-three people living with HIV']","['STA', 'placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET', 'rosuvastatin', 'Exercise Training and Statin Use', 'placebo', 'PLET', 'ET and statins']","['TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels', 'lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests', 'IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate', 'body fat mass, body fat percentage and increased lean body mass, MS and CF', 'total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}]",83.0,0.0940275,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","[{'ForeName': 'Hugo Ribeiro', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Master Institute of Education President Antônio Carlos, Araguari/MG, Brazil.'}, {'ForeName': 'Leandro Teixeira', 'Initials': 'LT', 'LastName': 'Paranhos Lopes', 'Affiliation': 'Brazil University, Fernandópolis/SP, Brazil.'}, {'ForeName': 'Edmar Lacerda', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Institute of Health Sciences, Department of Sport Sciences, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Mário Leon', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Fernando Freitas', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Elmiro Santos', 'Initials': 'ES', 'LastName': 'Resende', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002120']
3283,32095884,Comparison of Mill Suss™-guided radial artery catheterization with the long-axis in-plane ultrasound-guided method under general anesthesia: a randomized controlled trial.,"Continuous arterial blood pressure measurement is an effective perioperative monitoring method in patients with high-risk comorbidities. Recently, ultrasound guidance has been reported to facilitate radial artery catheterization. A new device, Mill Suss™, has also been developed for visualization of the radial artery and superficial veins using near-infrared laser light. In this study, we hypothesized that the Mill Suss-guided method might reduce the time and the number of attempts required for radial artery catheterization under general anesthesia, as compared to the long-axis in-plane ultrasound-guided method. Seventy-two adult patients aged 20-80 years, ASA physical status I or II, were randomly assigned to the Mill Suss-guided group (Group M: n = 36) or ultrasound-guided group (Group U: n = 36). Primary outcomes were the time required for successful radial artery catheterization and the number of cannulation attempts. There were no significant differences in the characteristics of patients between the two groups. The time required for successful radial artery catheterization was significantly shorter in Group M than in Group U. The number of attempts for successful cannulation was not statistically significantly different between the two groups. However, the results might be different among anesthesiologists well experienced in the ultrasound-guided method.",2020,The number of attempts for successful cannulation was not statistically significantly different between the two groups.,"['Seventy-two adult patients aged 20-80\xa0years, ASA physical status I or II', 'patients with high-risk comorbidities', 'plane ultrasound-guided method under general anesthesia']","['Mill Suss-guided group (Group M: n\u2009=\u200936) or ultrasound-guided group', 'Continuous arterial blood pressure measurement', 'Mill Suss™-guided radial artery catheterization']","['time required for successful radial artery catheterization', 'number of attempts for successful cannulation', 'time required for successful radial artery catheterization and the number of cannulation attempts']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0599997', 'cui_str': 'Mill (environment)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}]",72.0,0.0601745,The number of attempts for successful cannulation was not statistically significantly different between the two groups.,"[{'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Osuda', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan. elysium102@hotmail.com.'}, {'ForeName': 'Mitsutaka', 'Initials': 'M', 'LastName': 'Edanaga', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Anesthesia, Oji General Hospital, Tomakomai, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Ihara', 'Affiliation': 'Department of Anesthesia, Oji General Hospital, Tomakomai, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Anesthesia, Oji General Hospital, Tomakomai, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02749-z']
3284,31357259,Aerobic Training Performed at Ventilatory Threshold Improves Psychological Outcomes in Adolescents With Obesity.,"BACKGROUND
Physical activity may be as effective as some drugs for improving psychological outcomes; however, vigorous exercise may be needed for improving these outcomes in adolescents with obesity. The aim of this study is to examine the effects of low- and high-intensity training on self-esteem and symptoms of depression and anxiety in adolescents with obesity.
METHODS
A total of 62 pubertal adolescents with obesity (age 15 [1.5] y, body mass index 34.87 [4.22] kg/m2) were randomized into high-intensity group (HIG, n = 31) or low-intensity group (LIG, n = 31) for 24 weeks. All participants also received nutritional, psychological, and clinical counseling. Body composition and measures of depressive symptoms, anxiety, and self-esteem were assessed at baseline and after 24 weeks.
RESULTS
Depressive symptoms decreased significantly in both HIG (d = 1.16) and LIG (d = 0.45) (P ≤ .01). Trait anxiety decreased after 24 weeks for HIG (d = 0.81, P = .002) and LIG (d = 0.31, P = .002). No changes were observed in state anxiety or self-esteem.
CONCLUSIONS
Results from the present study demonstrate that 24 weeks of multidisciplinary intervention improves depression and anxiety symptoms in adolescents with obesity; however, the magnitude of changes is higher in HIG compared with LIG.",2019,"Trait anxiety decreased after 24 weeks for HIG (d = 0.81, P = .002) and LIG (d = 0.31, P = .002).","['adolescents with obesity', '62 pubertal adolescents with obesity (age 15 [1.5]\xa0y, body mass index 34.87 [4.22]\xa0kg/m2', 'Adolescents With Obesity']","['Aerobic Training Performed at Ventilatory Threshold', 'low- and high-intensity training', 'multidisciplinary intervention']","['Psychological Outcomes', 'self-esteem and symptoms of depression and anxiety', 'Trait anxiety', 'Depressive symptoms', 'depression and anxiety symptoms', 'Body composition and measures of depressive symptoms, anxiety, and self-esteem', 'state anxiety or self-esteem']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}]",62.0,0.0340544,"Trait anxiety decreased after 24 weeks for HIG (d = 0.81, P = .002) and LIG (d = 0.31, P = .002).","[{'ForeName': 'Yara', 'Initials': 'Y', 'LastName': 'Fidelix', 'Affiliation': ''}, {'ForeName': 'Mara C', 'Initials': 'MC', 'LastName': 'Lofrano-Prado', 'Affiliation': ''}, {'ForeName': 'Leonardo S', 'Initials': 'LS', 'LastName': 'Fortes', 'Affiliation': ''}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Caldwell', 'Affiliation': ''}, {'ForeName': 'João P', 'Initials': 'JP', 'LastName': 'Botero', 'Affiliation': ''}, {'ForeName': 'Wagner L', 'Initials': 'WL', 'LastName': 'do Prado', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0193']
3285,31874872,Development and evaluation of an intervention based on the provision of patient feedback to improve patient safety in Spanish primary healthcare centres: study protocol.,"INTRODUCTION
Despite the enormous potential for adverse events in primary healthcare (PHC), the knowledge about how to improve patient safety in this context is still sparse. We describe the methods for the development and evaluation of an intervention targeted at PHC professionals to improve patient safety in Spanish PHC centres.
METHODS AND ANALYSIS
The intervention will consist in using the patient reported experiences and outcomes of safety in primary care (PREOS-PC) survey to gather patient-reported experiences and outcomes concerning the safety of the healthcare patients receive in their PHC centres, and feed that information back to the PHC professionals to help them identify opportunities for safer healthcare provision. The study will involve three stages. Stage 1 (developing the intervention) will involve: (i) qualitative study with 40 PHC providers to optimise the acceptability and perceived utility of the proposed intervention; (ii) Spanish translation, cross-cultural adaptation and validation of the PREOS-PC survey; (iii) developing the intervention components; and (iv) developing an online tool to electronically administrate PREOS-PC and automatically generate feedback reports to PHC centres. Stage 2 (piloting the intervention) will involve a 3-month feasibility (one group pre-post) study in 10 PHC centres (500 patients, 260 providers). Stage 3 (evaluating the intervention) will involve: (i) a 12-month, two-arm, two-level cluster randomised controlled trial (1248 PHC professionals within 48 PHC centres; with randomisation at the centre level in a 1:1 ratio) to evaluate the impact of the intervention on patient safety culture (primary outcome), patient-reported safety experiences and outcomes (using the PREOS-PC survey), and avoidable hospitalisations; (ii) qualitative study with 20 PHC providers to evaluate the acceptability and perceived utility of the intervention and identify implementation barriers.
ETHICS AND DISSEMINATION
The study was approved by the Ethics Committee of the Balearic Islands (CEI IB: 3686/18) with the 1964 Helsinki Declaration and its later amendments. The results will be disseminated in peer-reviewed publications and national and international conferences.
TRIAL REGISTRATION NUMBER
NCT03837912; pre-results.",2019,"We describe the methods for the development and evaluation of an intervention targeted at PHC professionals to improve patient safety in Spanish PHC centres.
","['primary healthcare (PHC', 'Spanish primary healthcare centres', 'Spanish PHC centres']",[],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],[],500.0,0.0611907,"We describe the methods for the development and evaluation of an intervention targeted at PHC professionals to improve patient safety in Spanish PHC centres.
","[{'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Serrano-Ripoll', 'Affiliation': 'Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Palma, Balearic Islands, Spain.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Ripoll', 'Affiliation': 'Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Palma, Balearic Islands, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Llobera', 'Affiliation': 'Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Palma, Balearic Islands, Spain.'}, {'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'Valderas', 'Affiliation': 'Health Services and Policy Research, Medical School, University of Exeter, Exeter, Devon, UK.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Pastor-Moreno', 'Affiliation': 'CIBER Epidemiology and Public Health. CIBERESP, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Olry de Labry Lima', 'Affiliation': 'CIBER Epidemiology and Public Health. CIBERESP, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Ricci-Cabello', 'Affiliation': 'Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Palma, Balearic Islands, Spain ignacio.ricci@ssib.es.'}]",BMJ open,['10.1136/bmjopen-2019-031367']
3286,31874879,Qualitative exploration of women's experiences of intramuscular pethidine or remifentanil patient-controlled analgesia for labour pain.,"OBJECTIVES
To explore women's experiences of remifentanil or pethidine for labour pain and infant feeding behaviours at 6weeks post partum.
DESIGN
Qualitative postnatal sub-study to the randomised controlled trial of remifentanil intravenous patient controlled analgesia (PCA) versus intramuscular pethidine for pain relief in labour (RESPITE). Semistructured telephone interviews were conducted at 6 weeks post partum, and thematic analysis was undertaken.
SETTING
Women recruited to the RESPITE trial from seven UK hospitals.
PARTICIPANTS
Eighty women consented and 49 (30 remifentanil group and 19 pethidine group) completed the interview.
RESULTS
Eight themes emerged which encompassed women's antenatal plans for pain management ( Birth Expectations ) through to their future preferences for pain relief ( Reflections for Future Choices ). Many women who used remifentanil felt it provided effective pain relief ( Effectiveness of Pain Relief ), whereas women in the pethidine group expressed more mixed views. Both groups described side effects, with women using pethidine frequently reporting nausea ( Negative Physiological Responses ) and women using remifentanil describing more cognitive effects ( Cognitive Effects ). Some women who used remifentanil reported restricted movements due to technical aspects of drug administration and fear of analgesia running out ( Issues with Drug Administration ). Women described how remifentanil enabled them to maintain their ability to stay focused during the birth ( Enabling a Sense of Control ). There was little difference in reported breastfeeding initiation and continuation between pethidine and remifentanil groups ( Impact on Infant Behaviour and Breastfeeding ).
CONCLUSIONS
Qualitative insights from a follow-up study to a trial which explored experiences of intravenous remifentanil PCA with intramuscular pethidine injection found that remifentanil appeared to provide effective pain relief while allowing women to remain alert and focused during labour, although as with pethidine, some side effects were noted. Overall, there was little difference in reported breastfeeding initiation and duration between the two groups.
TRIAL REGISTRATION NUMBER
ISRCTN29654603.",2019,"There was little difference in reported breastfeeding initiation and continuation between pethidine and remifentanil groups ( Impact on Infant Behaviour and Breastfeeding ).
","[""women's experiences of intramuscular"", 'Eighty women consented and 49 (30 remifentanil group and 19 pethidine group) completed the interview', 'patient-controlled analgesia for labour pain', 'pain relief in labour (RESPITE', 'Women recruited to the RESPITE trial from seven UK hospitals']","['pethidine injection', 'remifentanil or pethidine', 'remifentanil', 'pethidine', 'remifentanil intravenous patient controlled analgesia (PCA', 'remifentanil PCA']","['effective pain relief', 'effective pain relief ( Effectiveness of Pain Relief ', 'Infant Behaviour and Breastfeeding ', 'nausea ( Negative Physiological Responses ', 'labour pain and infant feeding behaviours', 'side effects']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0474368', 'cui_str': 'Labor Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0030625', 'cui_str': 'PCA'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0474368', 'cui_str': 'Labor Pain'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",80.0,0.0602575,"There was little difference in reported breastfeeding initiation and continuation between pethidine and remifentanil groups ( Impact on Infant Behaviour and Breastfeeding ).
","[{'ForeName': 'Victoria Hall', 'Initials': 'VH', 'LastName': 'Moran', 'Affiliation': 'College of Health and Wellbeing, University of Central Lancashire, Preston, UK VLMoran@uclan.ac.uk.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Thomson', 'Affiliation': 'College of Health and Wellbeing, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'College of Health and Wellbeing, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Storey', 'Affiliation': 'College of Health and Wellbeing, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Beeson', 'Affiliation': 'Birmingham Clinical Trials Unit, The University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'MacArthur', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Centre for Urgent and Emergency Care Research, University of Sheffield, Sheffield, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032203']
3287,31874882,Efficacy of periacetabular osteotomy followed by progressive resistance training compared to progressive resistance training as non-surgical treatment in patients with hip dysplasia (PreserveHip) - a protocol for a randomised controlled trial.,"INTRODUCTION
Periacetabular osteotomy (PAO) is an established treatment for adolescent and adult patients with hip dysplasia. However, the efficacy of PAO has not been tested against another surgical intervention or conservative treatment in a randomised controlled trial before. We suggest that progressive resistance training (PRT) could be an alternative to PAO. The primary aim of this trial is therefore to examine the efficacy of PAO followed by 4 months of usual care followed by 8 months of PRT compared to 12 months of solely PRT in patients with hip dysplasia eligible for PAO in terms of patient-reported pain measured by The Copenhagen Hip and Groin Outcome Score (HAGOS).
METHODS AND ANALYSIS
This trial is a single-blinded multicentre randomised controlled clinical trial, where patients with hip dysplasia, who are eligible for PAO, will be randomised to either PAO followed by usual care and PRT or PRT only. Primary outcome is patient-reported pain, measured on the subscale pain on the HAGOS questionnaire 12 months after initiation of PAO or PRT. The key secondary outcomes are the other subscales of the HAGOS, adverse and serious adverse events, usage of painkillers (yes/no) and type of analgesics. Based on the sample size calculation, the trial needs to include 96 patients.
ETHICS AND DISSEMINATION
The trial is approved by the Central Denmark Region Committee on Biomedical Research Ethics (Journal No 1-10-72-234-18) and by the Danish Data Protection Agency (Journal No 1-16-02-120-19). The trial is also approved by The Regional Committee for Medical and Health Research Ethics, Region South-East Norway (Ref. 2018/1603). All results from this trial will be published in international peer-reviewed scientific journals regardless of whether the results are positive, negative or inconclusive.
TRIAL REGISTRATION NUMBER
NCT03941171.",2019,"Primary outcome is patient-reported pain, measured on the subscale pain on the HAGOS questionnaire 12 months after initiation of PAO or PRT.","['patients with hip dysplasia, who are eligible for PAO', '96 patients', 'patients with hip dysplasia eligible for PAO', 'patients with hip dysplasia (PreserveHip', 'adolescent and adult patients with hip dysplasia']","['periacetabular osteotomy followed by progressive resistance training', 'Periacetabular osteotomy (PAO', 'PAO', 'progressive resistance training (PRT', 'progressive resistance training']","['subscales of the HAGOS, adverse and serious adverse events, usage of painkillers (yes/no) and type of analgesics', 'Danish Data Protection Agency', 'patient-reported pain, measured on the subscale pain on the HAGOS questionnaire', 'Copenhagen Hip and Groin Outcome Score (HAGOS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1328407', 'cui_str': 'Hip Dysplasia'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",96.0,0.202605,"Primary outcome is patient-reported pain, measured on the subscale pain on the HAGOS questionnaire 12 months after initiation of PAO or PRT.","[{'ForeName': 'Lisa Cecilie Urup', 'Initials': 'LCU', 'LastName': 'Reimer', 'Affiliation': 'Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark lisareimer@clin.au.dk.'}, {'ForeName': 'Stig Storgaard', 'Initials': 'SS', 'LastName': 'Jakobsen', 'Affiliation': 'Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Mortensen', 'Affiliation': 'Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Public Health - Sport, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Julie Sandell', 'Initials': 'JS', 'LastName': 'Jacobsen', 'Affiliation': 'Physiotherapy & Research Centre for Health and Welfare Technology, Programme for Rehabilitation, VIA University College, Aarhus, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Soballe', 'Affiliation': 'Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Bere', 'Affiliation': 'Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jan Erik', 'Initials': 'JE', 'LastName': 'Madsen', 'Affiliation': 'Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nordsletten', 'Affiliation': 'Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'May Arna', 'Initials': 'MA', 'LastName': 'Risberg', 'Affiliation': 'Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Mechlenburg', 'Affiliation': 'Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-032782']
3288,32106179,Prosthesis in Anterior Cervical Herniated Disc Approach Does Not Prevent Radiologic Adjacent Segment Degeneration.,"STUDY DESIGN
Retrospective analysis using data from RCTs OBJECTIVE.: This study aimed to report on the incidence of radiological adjacent segment degeneration (ASD) in patients with cervical radiculopathy due to a herniated disc that were randomized to receive cervical arthroplasty or arthrodesis.
SUMMARY OF BACKGROUND DATA
Cervical disc prostheses were introduced to prevent ASD in the post-surgical follow-up. However, it is still a controversial issue.
METHODS
253 Patients were included in two randomized, double-blinded trials comparing anterior cervical discectomy with arthroplasty (ACDA), with intervertebral cage (ACDF), or without intervertebral cage (ACD) for one-level disc herniation. Neutral lateral radiographs were obtained preoperatively, at 1- and 2-year follow-up after surgery. Radiological ASD was evaluated on X-ray and defined by a decrease in disc height and the presence of anterior osteophyte formation on both the superior and the inferior level in relation to the target level.
RESULTS
Radiological ASD was present in 34% of patients at baseline and increased to 59% at two-year follow-up in the arthrodesis groups (ACD and ACDF combined), and to 56% in the arthroplasty group. Progression of radiological ASD was present in 29% of patients in the arthrodesis group and in 31% of patients in the arthroplasty group for 2-year follow-up.
CONCLUSIONS
Radiological ASD occurs in a similar manner in patients that were subjected to arthrodesis in cervical radiculopathy and in patients that received arthroplasty to maintain motion. Current data tend to indicate that the advantage of cervical prosthesis in preventing radiological ASD is absent.
LEVEL OF EVIDENCE
2.",2020,"Progression of radiological ASD was present in 29% of patients in the arthrodesis group and in 31% of patients in the arthroplasty group for 2-year follow-up.
","['253 Patients', 'patients with cervical radiculopathy due to a herniated disc']","['anterior cervical discectomy with arthroplasty (ACDA), with intervertebral cage (ACDF), or without intervertebral cage (ACD', 'cervical arthroplasty or arthrodesis']","['Progression of radiological ASD', 'disc height', 'Radiological ASD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0742186', 'cui_str': 'Radiculopathy, Cervical'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0021818', 'cui_str': 'Disc, Herniated'}]","[{'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C0206078', 'cui_str': 'Diskectomy'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0442106', 'cui_str': 'Intervertebral (qualifier value)'}, {'cui': 'C0337189', 'cui_str': 'Cage, device (physical object)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0003881', 'cui_str': 'Arthrodesis'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}]",253.0,0.137081,"Progression of radiological ASD was present in 29% of patients in the arthrodesis group and in 31% of patients in the arthroplasty group for 2-year follow-up.
","[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, Leiden University Medical Centre, PO Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Donk', 'Affiliation': 'Department of Orthopaedic Surgery, Via Sana Clinics, Mill, The Netherlands.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Arts', 'Affiliation': 'Department of Neurosurgery, Haaglanden Medical Centre, PO Box 432, 2512 VA The Hague, The Netherlands.'}, {'ForeName': 'Ronald H M A', 'Initials': 'RHMA', 'LastName': 'Bartels', 'Affiliation': 'Department of Neurosurgery, Radboud University Medical Centre, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, The Netherlands.'}, {'ForeName': 'Carmen L A', 'Initials': 'CLA', 'LastName': 'Vleggeert-Lankamp', 'Affiliation': 'Department of Neurosurgery, Leiden University Medical Centre, PO Box 9600, 2300 RC Leiden, The Netherlands.'}]",Spine,['10.1097/BRS.0000000000003453']
3289,32107526,Clinical and Immunologic Outcomes after Immediate or Deferred Antiretroviral Therapy Initiation during Primary HIV Infection: The Sabes Randomized Clinical Study.,"BACKGROUND
In addition to demonstrated public health benefits on reducing transmission, it remains unclear how early antiretroviral therapy (ART) must be started after HIV acquisition to maximize individual benefits.
METHODS
We conducted an open-label randomized clinical study in Lima, Peru among adult MSM and transgender women with acute (HIV-antibody negative/HIV-1 RNA positive) or recent (confirmed negative HIV-antibody or RNA test within three months) HIV infection, who were randomized to start ART immediately vs defer by 24 weeks. We evaluated outcomes by treatment arm, and immunologic markers by days since estimated date of detectible infection (EDDI).
RESULTS
Of 216 participants, 105 were assigned to immediate arm and 111 to deferred arm (median age 26.8 years, 37% with acute HIV). The incidence of non-ART-related adverse events was lower in immediate vs deferred arm (83 vs 123/100 person-years, IRR 0.67 (95%CI 0.47, 0.95; p=0.02), the difference dominated by fewer infections in those treated immediately. After 24 weeks of ART, between-group differences in CD4/CD8 cell ratio lessened (p=0.09 overall), but differences between those initiating ART ≤30 days from EDDI (median 1.03, IQR 0.84, 1.37), and those initiating >90 days (0.88, IQR 0.61, 1.11) remained, p=0.02. Principal components analysis of 20 immune biomarkers demonstrated distinct patterns between those starting ART >90 days from EDDI vs those starting within 30 or 90 days (both p<0.001).
CONCLUSIONS
To our knowledge, this is the only evaluation of randomized ART initiation during primary HIV and provides evidence to explicitly consider acute HIV in WHO recommendations for universal ART.",2020,"The incidence of non-ART-related adverse events was lower in immediate vs deferred arm (83 vs 123/100 person-years, IRR 0.67 (95%CI 0.47, 0.95; p=0.02), the difference dominated by fewer infections in those treated immediately.","['216 participants', 'Primary HIV Infection', 'Lima, Peru among adult MSM and transgender women with acute (HIV-antibody negative/HIV-1 RNA positive) or recent']",[],"['detectible infection (EDDI', 'CD4/CD8 cell ratio lessened', 'incidence of non-ART-related adverse events']","[{'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C1142553', 'cui_str': 'Primary HIV infection'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C1142096', 'cui_str': 'HIV antibody negative'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]",[],"[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",216.0,0.32811,"The incidence of non-ART-related adverse events was lower in immediate vs deferred arm (83 vs 123/100 person-years, IRR 0.67 (95%CI 0.47, 0.95; p=0.02), the difference dominated by fewer infections in those treated immediately.","[{'ForeName': 'Javier R', 'Initials': 'JR', 'LastName': 'Lama', 'Affiliation': 'Asociacion Civil Impacta Salud y Educacion, Lima, Perú.'}, {'ForeName': 'Rachel A Bender', 'Initials': 'RAB', 'LastName': 'Ignacio', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Alfaro', 'Affiliation': 'Centro de Investigaciones Tecnologicas, Biomedicas y Medioambientales, Universidad Nacional Mayor de San Marcos, Lima, Perú.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Rios', 'Affiliation': 'Asociacion Civil Impacta Salud y Educacion, Lima, Perú.'}, {'ForeName': 'Jorge Gallardo', 'Initials': 'JG', 'LastName': 'Cartagena', 'Affiliation': 'Centro de Investigaciones Tecnologicas, Biomedicas y Medioambientales, Universidad Nacional Mayor de San Marcos, Lima, Perú.'}, {'ForeName': 'Rogelio', 'Initials': 'R', 'LastName': 'Valdez', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Bain', 'Affiliation': 'Program for the Appropriate use of Technology in Health, Seattle, WA, USA.'}, {'ForeName': 'Karin Sosa', 'Initials': 'KS', 'LastName': 'Barbarán', 'Affiliation': 'Centro de Investigaciones Tecnologicas, Biomedicas y Medioambientales, Universidad Nacional Mayor de San Marcos, Lima, Perú.'}, {'ForeName': 'Manuel V', 'Initials': 'MV', 'LastName': 'Villaran', 'Affiliation': 'Asociacion Civil Impacta Salud y Educacion, Lima, Perú.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Pilcher', 'Affiliation': 'Division of HIV, ID, and Global Medicine, Department of Medicine, University of California San Francisco, CA, USA.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gonzales', 'Affiliation': 'Asociacion Civil Impacta Salud y Educacion, Lima, Perú.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sanchez', 'Affiliation': 'Asociacion Civil Impacta Salud y Educacion, Lima, Perú.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Duerr', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa167']
3290,31874890,Efficacy of a computer-tailored web-based physical activity intervention using Fitbits for older adults: a randomised controlled trial protocol.,"INTRODUCTION
Physical activity is an integral part of healthy ageing, yet the majority of older adults 65+ years are not sufficiently active. Web-based physical activity interventions hold much promise to reach older adults. Preliminary evidence suggests that web-based interventions with tailored advice and Fitbits may be well suited for older adults.
METHODS AND ANALYSIS
This study aims to test the effectiveness of 'Active for Life', a 12-week computer-tailored web-based physical activity intervention using Fitbits for older adults. We will recruit 300 participants who will be randomly assigned to one of three trial arms: (1) web-based physical activity intervention with tailored advice only, (2) web-based physical activity intervention with tailored advice and Fitbit or (3) a wait-list control. The primary outcome, objective moderate to vigorous physical activity (MVPA) and secondary outcomes of objective sedentary behaviour, objective sleep, quality of life, social support, physical function and satisfaction with life will be assessed at baseline and week 12. The secondary outcomes of self-reported physical activity, sitting time and sleep will be assessed at baseline, week 6, 12 and 24. Website usability and participant satisfaction will be assessed at week 12 and website usage and intervention fidelity will be assessed from week 1 to 24. Intention-to-treat linear mixed model analyses will be used to test for group (tailoring only, tailoring +Fitbit, control) differences on changes in the main outcome, MVPA and secondary outcomes. Generalised linear models will be used to compare intervention groups (tailoring only, tailoring +Fitbit) on website usability, participant satisfaction, website usage and intervention fidelity.
ETHICS AND DISSEMINATION
The study has received ethics approval from the Central Queensland University Human Research Ethics Committee (H16/12-321). Study outcomes will be disseminated through peer-reviewed publications and academic conferences and used to inform improvements and dissemination of a tailored, web-based physical activity intervention for adults 65+ years.
TRIAL REGISTRATION NUMBER
Australian and New Zealand Clinical Trials Registry Number: ACTRN12618000646246.",2019,Website usability and participant satisfaction will be assessed at week 12 and website usage and intervention fidelity will be assessed from week 1 to 24.,"['300 participants who will be randomly assigned to one of three trial arms: (1', 'adults 65+ years', 'older adults', 'reach older adults', 'Australian and New Zealand']","['Web-based physical activity interventions', 'computer-tailored web-based physical activity intervention', 'web-based physical activity intervention with tailored advice only, (2) web-based physical activity intervention with tailored advice and Fitbit or (3) a wait-list control']","['objective moderate to vigorous physical activity (MVPA) and secondary outcomes of objective sedentary behaviour, objective sleep, quality of life, social support, physical function and satisfaction with life', 'Website usability and participant satisfaction', 'self-reported physical activity, sitting time and sleep']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0037438'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",300.0,0.120672,Website usability and participant satisfaction will be assessed at week 12 and website usage and intervention fidelity will be assessed from week 1 to 24.,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Alley', 'Affiliation': 'School of Health, Medical and Applied Sciences, Appleton Institute, Physical Activity Research Group, CQUniversity, Rockhampton, Queensland, Australia s.alley@cqu.edu.au.'}, {'ForeName': 'Jannique Gz', 'Initials': 'JG', 'LastName': 'van Uffelen', 'Affiliation': 'Department of Kinesiology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Schoeppe', 'Affiliation': 'School of Health, Medical and Applied Sciences, Appleton Institute, Physical Activity Research Group, CQUniversity, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Parkinson', 'Affiliation': 'School of Nursing, Midwifery and Social Sciences, Central Queensland University, Bundaburg, Queensland, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hunt', 'Affiliation': 'School of Nursing, Midwifery and Social Sciences, Central Queensland University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Power', 'Affiliation': 'School of Health, Medical and Applied Sciences, Appleton Institute, Physical Activity Research Group, CQUniversity, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Mitch J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'School of Medicine & Public Health, Priority Research Centre for Physical Activity and Nutrition, Faculty of Health and Medicine, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Schneiders', 'Affiliation': 'School of Health, Medical and Applied Sciences, Central Queensland University, Bundaburg, Queensland, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'School of Health, Medical and Applied Sciences, Appleton Institute, Physical Activity Research Group, CQUniversity, Rockhampton, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-033305']
3291,32076362,Drink goal difficulty effect on outcomes in moderation-based alcohol treatment for sexual minority men.,"Sexual minority men (SMM) who drink heavily are at a greater risk for developing alcohol use disorders (AUD) and associated negative consequences. Barriers to treatment prevent SMM from accessing traditional care, and moderation-based alcohol treatment is a more desirable alternative. As such, investigating effective goal setting in moderation-based alcohol treatment, particularly, which goals yield the most effective outcomes, is warranted. Applying the tenets of Goal Setting Theory, this study explored the relationship between goal difficulty and goal achievement. In a secondary data analysis of a randomized controlled trial that delivered a combination of medication (i.e., naltrexone) and behavioral (i.e., Modified Behavioral Self-Control Training) treatment for SMM with AUD (N = 178), generalized estimating equations tested the effect of goal difficulty (defined as the proposed magnitude of change from current drinking in number of drinking days and number of heavy drinking days) on goal achievement at Months 0, 3, 6, and 9. Goal importance, self-efficacy, and AUD severity were tested as moderators. Findings yielded a significant positive relationship between goal difficulty and goal achievement for number of drinking days but a negative relationship for the number of heavy drinking days. Moderators of these relationships were not found. In order to increase the likelihood of achieving their goals in moderation-based alcohol treatment, SMM should initially consider setting more difficult goals for reducing drinking days. Additionally, goals of more conservative difficulty should be set for reducing heavy drinking days.",2020,Sexual minority men (SMM) who drink heavily are at a greater risk for developing alcohol use disorders (AUD) and associated negative consequences.,"['SMM with AUD (N = 178', 'sexual minority men', 'Sexual minority men (SMM']","['moderation-based alcohol treatment', 'combination of medication (i.e., naltrexone) and behavioral (i.e., Modified Behavioral Self-Control Training']","['Goal importance, self-efficacy, and AUD severity']","[{'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",178.0,0.0208826,Sexual minority men (SMM) who drink heavily are at a greater risk for developing alcohol use disorders (AUD) and associated negative consequences.,"[{'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Levak', 'Affiliation': 'Center for Addiction Services and Personalized Interventions Research, Northwell Health, 1010 Northern Blvd. Suite 311, Great Neck, N.Y., 11021.'}, {'ForeName': 'Alexis N', 'Initials': 'AN', 'LastName': 'Kuerbis', 'Affiliation': 'Silberman School of Social Work, Hunter College, City University of New York, 2180 Third Avenue, New York, NY 10035.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Morgenstern', 'Affiliation': 'Center for Addiction Services and Personalized Interventions Research, Northwell Health, 1010 Northern Blvd. Suite 311, Great Neck, N.Y., 11021.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.01.001']
3292,31371154,Haemostasis in oral surgical procedures involving patients with a ventricular assist device.,"The purpose of this study was to determine whether tooth extraction for patients with ventricular assist devices (VADs) could be performed without interruption of anticoagulant and/or antiplatelet therapy and whether treatment with von Willebrand factor concentrates and desmopressin is required. The study consisted of three groups of patients undergoing oral surgery. The two experimental groups comprised patients with VADs, while the third group included cardiovascular patients without VADs who served as controls. All patients were treated intraoperatively with topical haemostatic agents (oxidized cellulose or collagen). The first group was additionally treated with fibrin glue. All 75 oral surgical procedures were performed under local anaesthesia without sedation. Three of 40 patients in the experimental groups and two of 20 patients in the control group suffered a haemorrhage, with no significant difference in the incidence of haemorrhage between the groups. The findings suggest that dental extraction can be performed without modification of oral anticoagulation or antiplatelet treatments, providing that INR is less than 3.5 on the day of the operation. It can further be hypothesized that an acquired coagulopathy in VAD patients does not influence the bleeding risk in dental extractions, and so the administration of desmopressin and/or von Willebrand factor concentrates is not required.",2020,"Three of 40 patients in the experimental groups and two of 20 patients in the control group suffered a haemorrhage, with no significant difference in the incidence of haemorrhage between the groups.","['patients with VADs, while the third group included cardiovascular patients without VADs who served as controls', 'patients undergoing oral surgery', 'patients with ventricular assist devices (VADs', 'patients with a ventricular assist device']","['local anaesthesia without sedation', 'topical haemostatic agents (oxidized cellulose or collagen', 'fibrin glue']","['incidence of haemorrhage', 'haemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038908', 'cui_str': 'Surgery, Maxillofacial'}, {'cui': 'C0085842', 'cui_str': 'Artificial Ventricle'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0007649', 'cui_str': 'Absorbable Cellulose'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",,0.0222906,"Three of 40 patients in the experimental groups and two of 20 patients in the control group suffered a haemorrhage, with no significant difference in the incidence of haemorrhage between the groups.","[{'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Hamzah', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany. Electronic address: hamzah@medizin.uni-leipzig.de.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Graf', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Kaluđerović', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany; Practice for Maxillofacial Surgery, Lepsiusstraße 2, 06618 Naumburg, Germany.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Meyer', 'Affiliation': 'University Department for Cardiac Surgery, Leipzig Heart Centre, Leipzig, Germany.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Dieterlen', 'Affiliation': 'University Department for Cardiac Surgery, Leipzig Heart Centre, Leipzig, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hemprich', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2019.07.009']
3293,32080973,Effectiveness of vialon biomaterial versus teflon catheters for peripheral intravenous placement: A randomized clinical trial.,"AIM
This study was to determine the effects of the two types of catheter material (vialon biomaterial and teflon) on pain intensity, dwell time, and phlebitis score for peripheral intravenous catheter (PIVC) placement.
METHODS
Participants (N = 208) were randomly assigned to the vialon biomaterial group (n = 104), the teflon group (n = 104). After the PIVC placement, the intensity of pain and phlebitis score were evaluated. Catheter dwell mean time was determined.
RESULTS
The pain intensity scores were similar immediately after inserting the PIVC. No difference was observed between the pain scores in both groups (p ≥ .050). Catheter dwell mean time for the vialon biomaterial catheter group (4.72 ± 1.20 days) was significantly longer compared to the teflon catheter group (4.10 ± 0.92 days) (p ≤ .001). It was determined that the catheter was removed due to phlebitis development in 16.3% of the vialon biomaterial catheter group and 53.8% of the teflon catheter group. An advanced level of statistically significant difference was found between the two groups in terms of phlebitis development scores (p ≤ .001).
CONCLUSIONS
This study concluded that vialon biomaterial catheter (BD Insyte™ Autoguard™ BC winged) demonstrates longer dwell time of PIVC, lower phlebitis rate and phlebitis score than teflon catheter (BD Venflon™).",2020,"An advanced level of statistically significant difference was found between the two groups in terms of phlebitis development scores (p ≤ .001).
","['peripheral intravenous placement', 'Participants (N = 208']","['peripheral intravenous catheter (PIVC) placement', 'catheter material (vialon biomaterial and teflon', 'vialon biomaterial group', 'vialon biomaterial catheter (BD Insyte™ Autoguard™ BC winged', 'vialon biomaterial versus teflon catheters']","['Catheter dwell mean time', 'pain intensity, dwell time, and phlebitis score', 'pain intensity scores', 'pain scores', 'intensity of pain and phlebitis score', 'dwell time of PIVC, lower phlebitis rate and phlebitis score', 'phlebitis development', 'phlebitis development scores']","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter, device (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0078223', 'cui_str': 'Vialon resin'}, {'cui': 'C0005479', 'cui_str': 'Biomaterials'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0429659', 'cui_str': 'Dwell time (observable entity)'}, {'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}]",208.0,0.065711,"An advanced level of statistically significant difference was found between the two groups in terms of phlebitis development scores (p ≤ .001).
","[{'ForeName': 'Betül', 'Initials': 'B', 'LastName': 'Kuş', 'Affiliation': 'Health Science Faculty, Yozgat Bozok University, Yozgat, Turkey.'}, {'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Büyükyılmaz', 'Affiliation': 'Florence Nightingale Faculty of Nursing, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12328']
3294,32073648,A randomized phase 2 network trial of tivantinib plus cetuximab versus cetuximab in patients with recurrent/metastatic head and neck squamous cell carcinoma.,"BACKGROUND
MET signaling is a well described mechanism of resistance to anti-EGFR therapy, and MET overexpression is common in head and neck squamous cell carcinomas (HNSCCs). In the current trial, the authors compared the oral MET inhibitor tivantinib (ARQ197) in combination with cetuximab (the TC arm) versus a control arm that received cetuximab monotherapy (C) in patients with recurrent/metastatic HNSCC.
METHODS
In total, 78 evaluable patients with cetuximab-naive, platinum-refractory HNSCC were enrolled, including 40 on the TC arm and 38 on the C arm (stratified by human papillomavirus [HPV] status). Patients received oral tivantinib 360 mg twice daily and intravenous cetuximab 500 mg/m 2 once every 2 weeks. The primary outcome was the response rate (according to Response Evaluation Criteria in Solid Tumors, version 1.1), and secondary outcomes included progression-free and overall survival. After patients progressed on the C arm, tivantinib monotherapy was optional.
RESULTS
The response rate was 7.5% in the TC arm (N = 3; 1 complete response) and 7.9% in the C arm (N = 3; not significantly different [NS]). The median progression-free survival in both arms was 4 months (NS), and the median overall survival was 8 months (NS). Both treatments were well tolerated, with a trend toward increased hematologic toxicities in the TC arm (12.5% had grade 3 leukopenia). The response rate in 31 HPV-positive/p16-positive patients was 0% in both arms, whereas the response rate in HPV-negative patients was 12.7% (12.5% in the TC arm and 13% in the C arm). Fifteen patients received tivantinib monotherapy, and no responses were observed.
CONCLUSIONS
Combined tivantinib plus cetuximab does not significantly improve the response rate or survival compared with cetuximab alone but does increase toxicity in an unselected HNSCC population. Cetuximab responses appear to be limited to patients who have HPV-negative HNSCC. MET-aberration-focused trials for HNSCC and the use of higher potency, selective MET inhibitors remain of interest.",2020,"CONCLUSIONS
Combined tivantinib plus cetuximab does not significantly improve the response rate or survival compared with cetuximab alone but does increase toxicity in an unselected HNSCC population.","['78 evaluable patients with cetuximab-naive, platinum-refractory HNSCC were enrolled, including 40 on the TC arm and 38 on the C arm (stratified by human papillomavirus [HPV] status', 'patients who have HPV-negative HNSCC', 'head and neck squamous cell carcinomas (HNSCCs', 'patients with recurrent/metastatic head and neck squamous cell carcinoma', 'patients with recurrent/metastatic HNSCC']","['cetuximab monotherapy (C', 'oral tivantinib 360 mg twice daily and intravenous cetuximab', 'tivantinib plus cetuximab versus cetuximab', 'tivantinib monotherapy']","['response rate or survival', 'progression-free and overall survival', 'median overall survival', 'response rate', 'median progression-free survival', 'toxicity', 'hematologic toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0221910', 'cui_str': 'Squamous Cells'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2987651'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}]",78.0,0.083564,"CONCLUSIONS
Combined tivantinib plus cetuximab does not significantly improve the response rate or survival compared with cetuximab alone but does increase toxicity in an unselected HNSCC population.","[{'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Kochanny', 'Affiliation': 'The University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'Francis P', 'Initials': 'FP', 'LastName': 'Worden', 'Affiliation': 'Division of Hematology/Oncology, Department of Internal Medicine, University of Michigan Hospital and Health Systems, Ann Arbor, Michigan.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Adkins', 'Affiliation': 'Siteman Cancer Center, Washington University, St. Louis, Missouri.'}, {'ForeName': 'Dean W', 'Initials': 'DW', 'LastName': 'Lim', 'Affiliation': 'Department of Medicine, City of Hope, Duarte, California.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Bauman', 'Affiliation': 'Department of Hematology and Oncology, University of Arizona Cancer Center, Phoenix, Arizona.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Wagner', 'Affiliation': 'Simon Cancer Center, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Brisson', 'Affiliation': 'Oakland University William Beaumont School of Medicine, Rochester, Michigan.'}, {'ForeName': 'Theodore G', 'Initials': 'TG', 'LastName': 'Karrison', 'Affiliation': 'The University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Stadler', 'Affiliation': 'The University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'Everett E', 'Initials': 'EE', 'LastName': 'Vokes', 'Affiliation': 'The University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'Tanguy Y', 'Initials': 'TY', 'LastName': 'Seiwert', 'Affiliation': 'Kimmel Cancer Center, Johns Hopkins Medicine, Baltimore, Maryland.'}]",Cancer,['10.1002/cncr.32762']
3295,32087003,Thorough QT/QTc Study Shows That a Novel 5-HT 4 Receptor Partial Agonist Minesapride Has No Effect on QT Prolongation.,"Minesapride (drug code: DSP-6952) is a potential gastrointestinal prokinetic agent with high selectivity for 5-hydroxytryptamine 4 (5-HT 4 ) receptor that acts as a partial agonist. Although 5-HT 4 receptor agonists are expected to show efficacy in patients with irritable bowel syndrome with constipation, only tegaserod is available for female patients, with limitations, in the United States. Previously, another 5-HT 4 receptor agonist, cisapride, was widely used for the treatment of upper gastrointestinal diseases, but was withdrawn from the market because of arrhythmia with QT prolongation. Chemically, benzamide is one of the most common structures among 5-HT 4 receptor agonists. Some benzamide derivatives, such as cisapride, are responsible for QT prolongation, while some, such as mosapride, are not. Thus, we planned a thorough QT/QTc study to investigate the effects of minesapride, a newly designed benzamide derivative, on the QT/QTc. This was a randomized, placebo-controlled, 4-arm, 4-period, crossover study conducted in healthy adults, with administration of single oral doses of minesapride (40 mg and 120 mg), placebo, and moxifloxacin in the fasted state. Minesapride and placebo were administered in a double-blind fashion, while the positive control moxifloxacin was administered in an open-label fashion. Japanese subjects (48 total: 24 males and 24 females) were randomized, and 47 subjects completed all treatment periods. A review of other electrocardiographic data revealed that neither therapeutic (40 mg) nor supratherapeutic (120 mg) doses of minesapride were associated with increased risk of prolonged QT interval.",2020,"Previously, another 5-HT 4 receptor agonist, cisapride, was widely used for the treatment of upper gastrointestinal diseases, but was withdrawn from the market because of arrhythmia with QT prolongation.","['Japanese subjects (48 total: 24 males and 24 females', 'patients with irritable bowel syndrome with constipation', 'healthy adults']","['placebo', 'Minesapride and placebo', 'placebo, and moxifloxacin', 'moxifloxacin', 'cisapride', 'supratherapeutic', 'Minesapride (drug code: DSP-6952', 'minesapride']","['risk of prolonged QT interval', 'QT Prolongation']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0072916', 'cui_str': 'Cisapride'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0009219', 'cui_str': 'Coding'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval (finding)'}]",24.0,0.101814,"Previously, another 5-HT 4 receptor agonist, cisapride, was widely used for the treatment of upper gastrointestinal diseases, but was withdrawn from the market because of arrhythmia with QT prolongation.","[{'ForeName': 'Tatsuto', 'Initials': 'T', 'LastName': 'Hamatani', 'Affiliation': 'Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Noda', 'Affiliation': 'Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Takagaki', 'Affiliation': 'Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Yasuhide', 'Initials': 'Y', 'LastName': 'Yodo', 'Affiliation': 'Data Science, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Kawai', 'Affiliation': 'Clinical Operation, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Kakuyama', 'Affiliation': 'Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kaji', 'Affiliation': 'Hakata Clinic, SOUSEIKAI, Fukuoka, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Fujio', 'Affiliation': 'Laboratory of Clinical Science and Biomedicine, Graduate School of Pharmaceutical Sciences, Osaka University, Suita, Osaka, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.778']
3296,31375042,Glycemic Variability and Hypoglycemic Excursions With Continuous Glucose Monitoring Compared to Intermittently Scanned Continuous Glucose Monitoring in Adults With Highest Risk Type 1 Diabetes.,"BACKGROUND
The I-HART CGM study has shown that real-time continuous glucose monitoring (rtCGM) has greater beneficial impact on hypoglycemia than intermittently scanned continuous glucose monitoring (iscCGM) in adults with type 1 diabetes at high risk (Gold score ≥4 or recent severe hypoglycemia using insulin injections). In this subanalysis, we present the impact of rtCGM and iscCGM on glycemic variability (GV).
METHODS
Forty participants were recruited to this parallel group study. Following two weeks of blinded rtCGM (DexcomG4), participants were randomized to rtCGM (Dexcom G5; n = 20) or iscCGM (Freestyle Libre; n = 20) for eight weeks. An open-extension phase enabled participants on rtCGM to continue for a further eight weeks and those on iscCGM to switch to rtCGM over this period. Glycemic variability measures at baseline, 8- and 16-week endpoints were compared between groups.
RESULTS
At the eight-week endpoint, between-group differences demonstrated significant reduction in several GV measures with rtCGM compared to iscCGM (GRADE%hypoglycemia, index of glycemic control [IGC], and average daily risk range [ADRR]; P < .05). Intermittently scanned continuous glucose monitoring reduced mean average glucose and glycemic variability percentage and GRADE%hyperglycemia compared with rtCGM ( P < .05). At 16 weeks, the iscCGM group switching to rtCGM showed significant improvement in GRADE%hypoglycemia, personal glycemic status, IGC, and ADRR.
CONCLUSION
Our data suggest most, but not all, GV measures improve with rtCGM compared with iscCGM, particularly those measures associated with the risk of hypoglycemia. Selecting appropriate glucose monitoring technology to address GV in this high-risk cohort is important to minimize the risk of glucose extremes and severe hypoglycemia.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov NCT03028220.",2020,Intermittently scanned continuous glucose monitoring reduced mean average glucose and glycemic variability percentage and GRADE%hyperglycemia compared with rtCGM ( P < .05).,"['adults with type 1 diabetes at high risk (Gold score ≥4 or recent severe hypoglycemia using insulin injections', 'Forty participants were recruited to this parallel group study', 'Adults With Highest Risk Type 1 Diabetes']","['rtCGM and iscCGM', 'scanned continuous glucose monitoring (iscCGM', 'Continuous Glucose Monitoring', 'rtCGM (Dexcom G5; n = 20) or iscCGM']","['glycemic variability (GV', 'iscCGM (GRADE%hypoglycemia, index of glycemic control [IGC], and average daily risk range [ADRR', 'risk of hypoglycemia', 'Glycemic Variability and Hypoglycemic Excursions', 'Glycemic variability measures', 'mean average glucose and glycemic variability percentage and GRADE%hyperglycemia', 'GRADE%hypoglycemia, personal glycemic status, IGC, and ADRR', 'several GV measures']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0586328', 'cui_str': 'Insulin injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0441633'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",40.0,0.0227794,Intermittently scanned continuous glucose monitoring reduced mean average glucose and glycemic variability percentage and GRADE%hyperglycemia compared with rtCGM ( P < .05).,"[{'ForeName': 'Parizad', 'Initials': 'P', 'LastName': 'Avari', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Moscardo', 'Affiliation': 'Department of Engineering, Universitat Politecnica de Valencia, Spain.'}, {'ForeName': 'Narvada', 'Initials': 'N', 'LastName': 'Jugnee', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Oliver', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Reddy', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, London, UK.'}]",Journal of diabetes science and technology,['10.1177/1932296819867688']
3297,32077470,GIP and GLP-1 Receptor Antagonism During a Meal in Healthy Individuals.,"CONTEXT
The actions of both endogenous incretin hormones during a meal have not previously been characterized.
OBJECTIVE
Using specific receptor antagonists, we investigated the individual and combined contributions of endogenous glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) to postprandial glucose metabolism, energy expenditure, and gallbladder motility.
DESIGN
Randomized, double-blinded, placebo-controlled, crossover design.
SETTING
On four separate days, four liquid mixed meal tests (1894 kJ) over 270 minutes (min).
PATIENTS OR OTHER PARTICIPANTS
Twelve healthy male volunteers.
INTERVENTIONS
Infusions of the GIP receptor antagonist GIP(3-30)NH2 (800 pmol/kg/min), the GLP-1 receptor antagonist exendin(9-39)NH2 (0-20 min: 1000 pmol/kg/min; 20-270 min: 450 pmol/kg/min), GIP(3-30)NH2+exendin(9-39)NH2, or placebo/saline.
MAIN OUTCOME MEASURE
Baseline-subtracted area under the curve (bsAUC) of C-peptide.
RESULTS
Infusion of GIP(3-30)NH2+exendin(9-39)NH2 significantly increased plasma glucose excursions (bsAUC: 261 ± 142 mmol/L × min) during the liquid mixed meals compared with GIP(3-30)NH2 (180 ± 141 mmol/L × min; P = 0.048), exendin(9-39)NH2 (171 ± 114 mmol/L × min; P = 0.046), and placebo (116 ± 154 mmol/L × min; P = 0.015). Correspondingly, C-peptide:glucose ratios during GIP(3-30)NH2+exendin(9-39)NH2 infusion were significantly lower than during GIP(3-30)NH2 (P = 0.0057), exendin(9-39)NH2 (P = 0.0038), and placebo infusion (P = 0.014). GIP(3-30)NH2 resulted in significantly lower AUCs for glucagon than exendin(9-39)NH2 (P = 0.0417). Gallbladder ejection fraction was higher during GIP(3-30)NH2 compared with placebo (P = 0.004). For all interventions, energy expenditure and respiratory quotient were similar.
CONCLUSIONS
Endogenous GIP and GLP-1 lower postprandial plasma glucose excursions and stimulate insulin secretion but only endogenous GIP affects gallbladder motility. The two incretin hormones potentiate each other's effects in the control of postprandial glycemia in healthy men.",2020,Gallbladder ejection fraction was higher during GIP(3-30)NH2 compared with placebo (P = 0.004).,"['healthy men', 'Healthy Individuals', 'Twelve healthy male volunteers']","['placebo', 'GIP(3-30)NH2+exendin(9-39)NH2, or placebo/saline', 'GIP receptor antagonist GIP(3-30)NH2', 'GIP(3-30)NH2+exendin(9-39)NH2', 'GIP and GLP-1 Receptor Antagonism', 'endogenous glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1']","['postprandial glycemia', 'Gallbladder ejection fraction', 'Baseline-subtracted area under the curve (bsAUC) of C-peptide', 'postprandial plasma glucose excursions', 'energy expenditure and respiratory quotient', 'Correspondingly, C-peptide:glucose ratios', 'plasma glucose excursions']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0061126', 'cui_str': 'glucose-dependent insulinotropic polypeptide receptor'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C4507209', 'cui_str': 'glucose insulinotropic polypeptide(3-30)amide'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",12.0,0.211064,Gallbladder ejection fraction was higher during GIP(3-30)NH2 compared with placebo (P = 0.004).,"[{'ForeName': 'Lærke S', 'Initials': 'LS', 'LastName': 'Gasbjerg', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads M', 'Initials': 'MM', 'LastName': 'Helsted', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Alexander H', 'Initials': 'AH', 'LastName': 'Sparre-Ulrich', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Veedfald', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Stensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Amalie R', 'Initials': 'AR', 'LastName': 'Lanng', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Natasha C', 'Initials': 'NC', 'LastName': 'Bergmann', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Mikkel B', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mette M', 'Initials': 'MM', 'LastName': 'Rosenkilde', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz175']
3298,31999876,Effects of progressive aquatic resistance training on symptoms and quality of life in women with knee osteoarthritis: A secondary analysis.,"OBJECTIVE
To conduct a secondary analysis to study the effects, those 4 months of aquatic resistance training have on self-assessed symptoms and quality of life in post-menopausal women with mild knee osteoarthritis (OA), after the intervention and after a 12-month follow-up period.
METHODS
A total of 87 post-menopausal volunteer women, aged 60-68 years, with mild knee OA were recruited in a randomized, controlled, 4-month aquatic training trial (RCT) and randomly assigned to an intervention (n = 43) and a control (n = 44) group. The intervention group participated in 48 supervised aquatic resistance training sessions over 4 months while the control group maintained their usual level of physical activity. Additionally, 77 participants completed the 12-month post-intervention follow-up period. Self-assessed symptoms were estimated using the OA-specific Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and Health-related Quality of life (HRQoL) using the generic Short-form Health Survey (SF-36).
RESULTS
After 4 months of aquatic resistance training, there was a significant decrease in the stiffness dimension of WOMAC -8.5 mm (95% CI = -14.9 to -2.0, P = .006) in the training group compared to the controls. After the cessation of the training, this benefit was no longer observed during the 12-month follow-up. No between-group differences were observed in any of the SF-36 dimensions.
CONCLUSIONS
The results of this study show that participation in an intensive aquatic resistance training program did not have any short- or long-term impact on pain and physical function or quality of life in women with mild knee OA. However, a small short-term decrease in knee stiffness was observed.",2020,"No between-group differences were observed in any of the SF-36 dimensions.
","['women with knee osteoarthritis', 'women with mild knee OA', '87 postmenopausal volunteer women, aged 60-68 years, with mild knee OA', 'postmenopausal women with mild knee osteoarthritis (OA', '77 participants completed the 12-month post-intervention follow-up period']","['48 supervised aquatic resistance training sessions', 'aquatic training trial (RCT', 'progressive aquatic resistance training', 'aquatic resistance training']","['symptoms and quality of life', 'knee stiffness', 'stiffness dimension of WOMAC', 'self-assessed symptoms and quality of life', 'SF-36 dimensions', 'pain and physical function or quality of life', 'OA-specific Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and Health-related Quality of life (HRQoL']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",87.0,0.056066,"No between-group differences were observed in any of the SF-36 dimensions.
","[{'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Munukka', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Waller', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Arja', 'Initials': 'A', 'LastName': 'Häkkinen', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Miika T', 'Initials': 'MT', 'LastName': 'Nieminen', 'Affiliation': 'Research Unit of Medical Imaging, Physics and Technology, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Eveliina', 'Initials': 'E', 'LastName': 'Lammentausta', 'Affiliation': 'Department of Diagnostic Radiology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Urho M', 'Initials': 'UM', 'LastName': 'Kujala', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Paloneva', 'Affiliation': 'Department of Surgery, Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Kiviranta', 'Affiliation': 'Department of Orthopaedics and Traumatology, University of Helsinki, and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Heinonen', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13630']
3299,32071431,Early treatment with FCR versus watch and wait in patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL): a randomized phase 3 trial.,"We report a randomized prospective phase 3 study (CLL7), designed to evaluate the efficacy of fludarabine, cyclophosphamide, and rituximab (FCR) in patients with an early-stage high-risk chronic lymphocytic leukemia (CLL). Eight hundred patients with untreated-stage Binet A disease were enrolled as intent-to-treat population and assessed for four prognostic markers: lymphocyte doubling time <12 months, serum thymidine kinase >10 U/L, unmutated IGHV genes, and unfavorable cytogenetics (del(11q)/del(17p)/trisomy 12). Two hundred and one patients with ≥2 risk features were classified as high-risk CLL and 1:1 randomized to receive either immediate therapy with 6xFCR (Hi-FCR, 100 patients), or to be observed according to standard of care (Hi-W&W, 101 patients). The overall response rate after early FCR was 92.7%. Common adverse events were hematological toxicities and infections (61.0%/41.5% of patients, respectively). After median observation time of 55.6 (0-99.2) months, event-free survival was significantly prolonged in Hi-FCR compared with Hi-W&W patients (median not reached vs. 18.5 months, p < 0.001). There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864). In conclusion, although FCR is efficient to induce remissions in the Binet A high-risk CLL, our data do not provide evidence that alters the current standard of care ""watch and wait"" for these patients.",2020,"There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864).","['Two hundred and one patients with ≥2 risk features were classified as high-risk CLL', 'patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL', 'Eight hundred patients with untreated-stage Binet A disease were enrolled as intent-to-treat population and assessed for four prognostic markers: lymphocyte doubling time <12 months, serum thymidine kinase >10\u2009U/L, unmutated IGHV genes, and unfavorable cytogenetics (del(11q)/del(17p)/trisomy 12', 'patients with an early-stage high-risk chronic lymphocytic leukemia (CLL']","['immediate therapy with 6xFCR', 'fludarabine, cyclophosphamide, and rituximab (FCR', 'FCR']","['hematological toxicities and infections', 'overall survival benefit', 'overall response rate', 'event-free survival']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040078', 'cui_str': 'Deoxythymidine Kinase'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0432408', 'cui_str': 'Trisomy 12 (disorder)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",800.0,0.142644,"There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864).","[{'ForeName': 'Carmen D', 'Initials': 'CD', 'LastName': 'Herling', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany. carmen.herling@uk-koeln.de.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Cymbalista', 'Affiliation': ""Hopital Avicenne, Assistance Publique-Hopitaux de Paris (AP-HP), Service d'Hematologie Biologique, Bobigny, France.""}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Groß-Ophoff-Müller', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Bahlo', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Langerbeins', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Othman', 'Initials': 'O', 'LastName': 'Al-Sawaf', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Raymonde', 'Initials': 'R', 'LastName': 'Busch', 'Affiliation': 'Institute for Medical Statistics and Epidemiology, Technical University, Munich, Germany.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Porcher', 'Affiliation': 'Center of Clinical Epidemiology, Hopital Hotel-Dieu, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cazin', 'Affiliation': 'Service de Maladies du Sang, CHU Claude Huriez, Lille Cedex, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dreyfus', 'Affiliation': ""Service d'Hematologie, CHU Poitiers, Poitiers, France.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ibach', 'Affiliation': 'WiSP Wissenschaftlicher Service Pharma GmbH, Langenfeld, Germany.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Leprêtre', 'Affiliation': 'Inserm Unit U1245 and Department of Hematology, Cancer Centre Henri Becquerel and Normandie University Rouen, Rouen, France.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'Day Clinic Hematology Oncology Palliative Care, Landshut, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Clemens-Martin', 'Initials': 'CM', 'LastName': 'Wentner', 'Affiliation': 'Department of Hematology Oncology, Immunology, Palliative Medicine, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Manuela A', 'Initials': 'MA', 'LastName': 'Hoechstetter', 'Affiliation': 'Department of Hematology Oncology, Immunology, Palliative Medicine, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Leblond', 'Affiliation': 'Department of Haematology, Hopital de la Pitie-Salpetriere, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kneba', 'Affiliation': 'Second Department of Medicine, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'Letestu', 'Affiliation': ""Hopital Avicenne, Assistance Publique-Hopitaux de Paris (AP-HP), Service d'Hematologie Biologique, Bobigny, France.""}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Böttcher', 'Affiliation': 'Second Department of Medicine, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Levy', 'Affiliation': 'Unite de Recherche Clinique, Hopital Avicenne, Bobigny, France.'}]",Leukemia,['10.1038/s41375-020-0747-7']
3300,32073384,"Making Informed CHOICES: The Launch of a ""Big Data"" Pragmatic Trial to Improve Cholesterol Management and Prevent Heart Disease in Ontario.","Cholesterol-lowering statin medications are a safe and effective therapy to lower cholesterol and reduce the risk of cardiovascular events. Yet physician prescribing patterns and patient adherence remain suboptimal in Canada and the United States, often due to pervasive misconceptions. The Community Heart Outcomes Improvement and Cholesterol Education Study (CHOICES) is a pragmatic, registry-based, cluster randomized controlled trial that aims to improve cholesterol management through appropriate statin use in adults and to ultimately reduce cardiovascular events in high-risk communities across Ontario. The trial uses an innovative, multicomponent intervention and implementation approach that includes audit and feedback reports for family physicians and educational materials and tools for patients.",2020,"The trial uses an innovative, multicomponent intervention and implementation approach that includes audit and feedback reports for family physicians and educational materials and tools for patients.",['high-risk communities across Ontario'],['Cholesterol-lowering statin medications'],['cardiovascular events'],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}]","[{'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.0999119,"The trial uses an innovative, multicomponent intervention and implementation approach that includes audit and feedback reports for family physicians and educational materials and tools for patients.","[{'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Ferreira-Legere', 'Affiliation': 'A research project manager with the CHOICES trial and the Cardiovascular Research Program at ICES in Toronto.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Chu', 'Affiliation': 'A senior epidemiologist with the Cardiovascular Research Program at ICES.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Rashid', 'Affiliation': 'An analyst with the Cardiovascular Research Program at ICES.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Sivaswamy', 'Affiliation': 'An analyst with the Cardiovascular Research Program at ICES.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': ""O'Neill"", 'Affiliation': 'A research assistant with the Cardiovascular Research Program at ICES.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Marquez', 'Affiliation': ""A research coordinator with the Knowledge Translation Program at the Li Ka Shing Knowledge Institute of St. Michael's Hospital in Toronto.""}, {'ForeName': 'Richelle', 'Initials': 'R', 'LastName': 'Baddeliyanage', 'Affiliation': ""A research assistant with the Knowledge Translation Program at the Li Ka Shing Knowledge Institute of St. Michael's Hospital.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Straus', 'Affiliation': ""director of the Knowledge Translation Program at the Li Ka Shing Knowledge Institute of St. Michael's Hospital, where she is physician-in-chief, and a professor of medicine at the University of Toronto.""}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Udell', 'Affiliation': ""A cardiologist and clinician-scientist at Women's College Hospital and the Peter Munk Cardiac Centre of the University Health Network and an associate professor of medicine at the University of Toronto. He is an adjunct scientist at ICES and co-principal investigator for the CHOICES trial. Dr. Udell can be contacted by e-mail at jay.udell@utoronto.ca.""}]","Healthcare quarterly (Toronto, Ont.)",['10.12927/hcq.2020.26091']
3301,31377215,The Role of Heart Rate Variability in Mindfulness-Based Pain Relief.,"Mindfulness meditation is a self-regulatory practice premised on sustaining nonreactive awareness of arising sensory events that reliably reduces pain. Yet, the specific analgesic mechanisms supporting mindfulness have not been comprehensively disentangled from the potential nonspecific factors supporting this technique. Increased parasympathetic nervous system (PNS) activity is associated with pain relief corresponding to a number of cognitive manipulations. However, the relationship between the PNS and mindfulness-based pain attenuation remains unknown. The primary objective of the present study was to determine the role of high-frequency heart rate variability (HF HRV), a marker of PNS activity, during mindfulness-based pain relief as compared to a validated, sham-mindfulness meditation technique that served as a breathing-based control. Sixty-two healthy volunteers (31 females; 31 males) were randomized to a 4-session (25 min/session) mindfulness or sham-mindfulness training regimen. Before and after each group's respective training, participants were administered noxious (49°C) and innocuous (35°C) heat to the right calf. HF HRV and respiration rate were recorded during thermal stimulation and pain intensity and unpleasantness ratings were collected after each stimulation series. The primary analysis revealed that during mindfulness meditation, higher HF HRV was more strongly associated with lower pain unpleasantness ratings when compared to sham-mindfulness meditation (B = -.82, P = .04). This finding is in line with the prediction that mindfulness-based meditation engages distinct mechanisms from sham-mindfulness meditation to reduce pain. However, the same prediction was not confirmed for pain intensity ratings (B = -.41). Secondary analyses determined that mindfulness and sham-mindfulness meditation similarly reduced pain ratings, decreased respiration rate, and increased HF HRV (between group ps < .05). More mechanistic work is needed to reliably determine the role of parasympathetic activation in mindfulness-based pain relief as compared to other meditative techniques. Perspective: Mindfulness has been shown to engage multiple mechanisms to reduce pain. The present study extends on this work to show that higher HRV is associated with mindfulness-induced reductions in pain unpleasantness, but not pain intensity ratings, when compared to sham-mindfulness meditation. These findings warrant further investigation into the mechanisms engaged by mindfulness as compared to placebo.",2020,"The primary analysis revealed that during mindfulness meditation, higher HF HRV was more strongly associated with lower pain unpleasantness ratings when compared to sham-mindfulness meditation (B = -0.82, p = 0.04).",['Sixty-two healthy volunteers (31 females; 31 males'],"['placebo', 'session) mindfulness or sham-mindfulness training regimen', 'Mindfulness meditation']","['pain unpleasantness ratings', 'Increased parasympathetic nervous system (PNS) activity', 'pain', 'pain ratings, decreased respiration rate, and increased HF HRV', 'HF HRV', 'pain unpleasantness', 'pain intensity and unpleasantness ratings', 'pain intensity ratings', 'HF HRV and respiration rate']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0150277'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0030510', 'cui_str': 'Parasympathetic Nervous System'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}]",62.0,0.0356322,"The primary analysis revealed that during mindfulness meditation, higher HF HRV was more strongly associated with lower pain unpleasantness ratings when compared to sham-mindfulness meditation (B = -0.82, p = 0.04).","[{'ForeName': 'Adrienne L', 'Initials': 'AL', 'LastName': 'Adler-Neal', 'Affiliation': 'Department of Neurobiology and Anatomy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Christian E', 'Initials': 'CE', 'LastName': 'Waugh', 'Affiliation': 'Department of Psychology, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Garland', 'Affiliation': 'College of Social Work & Center on Mindfulness and Integrative Health Intervention Development, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Hossam A', 'Initials': 'HA', 'LastName': 'Shaltout', 'Affiliation': 'Department of Surgery/Hypertension and Vascular Research, Cardiovascular Sciences Center, Winston-Salem, North Carolina; Department of Obstetrics and Gynecology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Debra I', 'Initials': 'DI', 'LastName': 'Diz', 'Affiliation': 'Department of Surgery/Hypertension and Vascular Research, Cardiovascular Sciences Center, Winston-Salem, North Carolina.'}, {'ForeName': 'Fadel', 'Initials': 'F', 'LastName': 'Zeidan', 'Affiliation': 'Department of Neurobiology and Anatomy, Wake Forest School of Medicine, Winston-Salem, North Carolina; Department of Anesthesiology, University of California San Diego, San Diego, California. Electronic address: fzeidan@ucsd.edu.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.07.003']
3302,32072749,Sex as a moderator of body composition following a randomized controlled lifestyle intervention among Latino youth with obesity.,"BACKGROUND
Body composition differences between males and females emerge during adolescence and continue throughout adulthood; however, whether sex moderates body composition changes in adolescents with obesity after an intervention is unknown.
OBJECTIVE
To examine sex as a moderator of changes in adiposity following lifestyle intervention.
METHODS
A total of 136 Latino youth with obesity (BMI% 98.2 ± 1.3) aged 14 to 16 years old were randomized to either a 12-week lifestyle intervention (27 males/40 females) or control (35 males/34 females) group. The intervention included nutrition education (1 h/wk) and moderate-to-vigorous physical activity (3 h/wk). Anthropometric data (body mass index [BMI], BMI%, waist circumference, total body fat, and fat-free mass) were obtained pre- and post-intervention. Sex differences were examined by general linear models with significance determined at P < .05 for the F-statistic.
RESULTS
Sex did not moderate changes in BMI (F 1,115 = 0.01, P = .9), BMI% (F 1,115 = 0.14, P = .7), or waist circumference (F 1,117 = 1.1, P = .3). Sex significantly moderated changes in body fat percent (F 1,117 = 5.3, P = .02), fat mass (F 1,116 = 4.5, P = .04), and fat-free mass (F 1,116 = 4.3, P = .04). Intervention males compared with females had greater relative reductions in fat percent (-4.1 ± 0.8% vs -1.2 ± 0.7%, P = .02) and fat mass (-5.0 ± 1.1 kg vs -1.5 ± 0.9 kg, P = .02) and gained more fat free mass (3.6 ± 0.9 kg vs 0.5 ± 0.8 kg, P = .02) when compared with same sex controls.
CONCLUSION
Males and females exhibited a differential response to lifestyle intervention for percent fat, fat mass, and fat-free mass indicating that sex-specific improvements in body composition favours males over females.",2020,"Sex significantly moderated changes in body fat percent (F 1,117 = 5.3, P = .02), fat mass (F 1,116 = 4.5, P = .04), and fat-free mass (F 1,116 = 4.3, P = .04).","['Latino youth with obesity', '136 Latino youth with obesity (BMI% 98.2\u2009±\u20091.3) aged 14 to 16\u2009years old', '27 males/40 females) or control (35 males/34 females) group']",['lifestyle intervention'],"['waist circumference', 'fat mass', 'fat-free mass', 'Anthropometric data (body mass index [BMI], BMI%, waist circumference, total body fat, and fat-free mass', 'BMI']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0424677', 'cui_str': 'Total body fat (observable entity)'}]",136.0,0.0308452,"Sex significantly moderated changes in body fat percent (F 1,117 = 5.3, P = .02), fat mass (F 1,116 = 4.5, P = .04), and fat-free mass (F 1,116 = 4.3, P = .04).","[{'ForeName': 'Kiley B', 'Initials': 'KB', 'LastName': 'Vander Wyst', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Micah L', 'Initials': 'ML', 'LastName': 'Olson', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Colleen S', 'Initials': 'CS', 'LastName': 'Keller', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Erica G', 'Initials': 'EG', 'LastName': 'Soltero', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Allison N', 'Initials': 'AN', 'LastName': 'Williams', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Peña', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Ayers', 'Affiliation': 'Southwest Interdisciplinary Research Center, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Jager', 'Affiliation': 'T. Denny Sanford School of Social and Family Dynamics, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Gabriel Q', 'Initials': 'GQ', 'LastName': 'Shaibi', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Arizona State University, Phoenix, Arizona.'}]",Pediatric obesity,['10.1111/ijpo.12620']
3303,32072150,Long Term Follow-up Data and Health-Related Quality of Life in Frontline Therapy of Fit Patients Treated With FCR Versus BR (CLL10 Trial of the GCLLSG).,"Fludarabine, cyclophosphamide and rituximab (FCR) was compared to bendamustine and rituximab (BR) in an international, randomized, open label, phase 3 trial in 561 previously untreated, fit patients with chronic lymphocytic leukemia (CLL) without del (17p). Primary endpoint was progression free survival (PFS). The final primary endpoint analysis after 37.1 months median follow up failed to show the non-inferiority of BR as compared with FCR. With extended median follow up of 58.2 months, median PFS was 42.3 months in BR-treated patients versus 57.6 months for FCR-treated patients (Hazard Ratio [HR] 1.593; 95% CI 1.271-1.996; p < 0.0001). For patients > 65 years, median PFS was 48.5 months with BR versus 57.9 months with FCR without reaching statistical significance (HR 1.352; 95% CI 0.912-2.006; p = 0.134). Median OS was not reached for both arms with 5-year OS rates of 80.1% vs 80.9%, respectively (HR 1.108; 95% CI 0.755-1.627; p = 0.599). No statistically significant difference was found in the time to secondary malignancy between the 2 groups (at 5 years, 86.6% free from secondary malignancies in the BR group vs 83.8% in the FCR group [HR 0.801; 95% CI 0.507-1.267; p = 0.344]). In patients >65 years secondary neoplasia occurred more frequently after FCR treatment [28 of 86 (32.6%) patients] as compared with BR [18 of 107 (16.8%) patients; p = 0.011]. Health-related quality of life was similar in both treatments. Despite the improved PFS for FCR, OS did not differ. These results also suggest an increase in secondary neoplasia associated with FCR in elderly fit CLL patients.",2020,"For patients > 65 years, median PFS was 48.5 months with BR versus 57.9 months with FCR without reaching statistical significance (HR 1.352; 95% CI 0.912-2.006; p = 0.134).","['Fit Patients', '561 previously untreated, fit patients with chronic lymphocytic leukemia (CLL) without del (17p', 'elderly fit CLL patients']","['bendamustine and rituximab (BR', 'FCR', 'Fludarabine, cyclophosphamide and rituximab (FCR']","['neoplasia', 'median PFS', 'Median OS', 'Health-related quality of life', 'progression free survival (PFS', '5-year OS rates', 'time to secondary malignancy', 'secondary neoplasia']","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",561.0,0.108604,"For patients > 65 years, median PFS was 48.5 months with BR versus 57.9 months with FCR without reaching statistical significance (HR 1.352; 95% CI 0.912-2.006; p = 0.134).","[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Kutsch', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Bahlo', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Franklin', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Maurer', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'De Silva', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lange', 'Affiliation': 'Department of Hematology and Oncology, Evangelisches Krankenhaus Hamm, Hamm, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Weide', 'Affiliation': 'Praxis fuer Haematologie und Onkologie, Koblenz, Germany.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Kiehl', 'Affiliation': 'Department of Internal Medicine, Frankfurt (Oder) General Hospital, Frankfurt/Oder, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sökler', 'Affiliation': 'Department II of Internal Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Schlag', 'Affiliation': 'Practice for Oncology, Würzburg, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Vehling-Kaiser', 'Affiliation': 'Oncology and Palliative Care, Day clinic Landshut, Landshut, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Köchling', 'Affiliation': 'Private Oncology Practice, Villingen-Schwenningen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Plöger', 'Affiliation': 'Private Oncology Practice, Mannheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gregor', 'Affiliation': 'Division of Hematology, Cantonal Hospital of Lucerne, Lucerne, Switzerland.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Plesner', 'Affiliation': 'Department of Hematology, Vejle Hospital, Vejle, Denmark.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Herling', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kneba', 'Affiliation': 'Department of Medicine II, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Clemens-Martin', 'Initials': 'CM', 'LastName': 'Wendtner', 'Affiliation': 'Department of Hematology, Oncology, Immunology, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Klapper', 'Affiliation': 'Hematopathology Section, Christian-Albrechts-University Kiel, Kiel, Germany.'}, {'ForeName': 'Karl-Anton', 'Initials': 'KA', 'LastName': 'Kreuzer', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Böttcher', 'Affiliation': 'Department of Medicine II, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf and German CLL Study Group, University of Cologne, Germany.'}]",HemaSphere,['10.1097/HS9.0000000000000336']
3304,31343582,A Motivational Telephone Intervention to Reduce Early Dropouts in Cardiac Rehabilitation: A FEASIBILITY PILOT STUDY.,"PURPOSE
Cardiac rehabilitation (CR) improves outcomes, yet early dropout is common. The purpose of the study was to determine whether a motivational telephone intervention among patients at risk for nonadherence would reduce early dropouts.
METHODS
We performed a randomized double-blind pilot study with the intervention group receiving the telephone intervention 1 to 3 d after outpatient CR orientation. The control group received the standard of care, which did not routinely monitor attendance until 2 wk after orientation. The primary outcome was the percentage of patients who attended their second exercise session as scheduled. Secondary outcomes included attendance at the second CR session at any point and total number of sessions attended. Because not everyone randomized to the intervention was able to be contacted, we also conducted a per-protocol analysis.
RESULTS
One hundred patients were randomized to 2 groups (age 62 ± 15 yr, 46% male, 40% with myocardial infarction) with 49 in the intervention group. Patients who received the intervention were more likely to attend their second session as scheduled compared with the standard of care (80% vs 49%; relative risk = 1.62; 95% CI, 1.18-2.22). Although there was no difference in total number of sessions between groups, there was a statistically significant improvement in overall return rate among the per-protocol group (87% vs 66%; relative risk = 1.31; 95% CI, 1.05-1.63).
CONCLUSIONS
A nursing-based telephone intervention targeted to patients at risk for early dropout shortly after their CR orientation improved both on-time and eventual return rates. This straightforward strategy represents an attractive adjunct to improve adherence to outpatient CR.",2019,"Although there was no difference in total number of sessions between groups, there was a statistically significant improvement in overall return rate among the per-protocol group (87% vs 66%; relative risk = 1.31; 95% CI, 1.05-1.63).
","['Cardiac Rehabilitation', 'One hundred patients were randomized to 2 groups (age 62 ± 15 yr, 46% male, 40% with myocardial infarction) with 49 in the intervention group', 'patients at risk for nonadherence would reduce early dropouts']","['Cardiac rehabilitation (CR', 'motivational telephone intervention', 'Motivational Telephone Intervention', 'telephone intervention']","['attendance at the second CR session at any point and total number of sessions attended', 'total number of sessions', 'overall return rate']","[{'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",100.0,0.133681,"Although there was no difference in total number of sessions between groups, there was a statistically significant improvement in overall return rate among the per-protocol group (87% vs 66%; relative risk = 1.31; 95% CI, 1.05-1.63).
","[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'LaValley', 'Affiliation': 'Baystate Health Systems, Springfield, Massachusetts (Drs LaValley, Farah, and Pack and Mrs Szalai); Elms College, Chicopee, Massachusetts (Drs LaValley and Storer); University of Massachusetts Medical School at Baystate, Springfield (Dr Pack); and Center for Health Care Delivery and Population Science, Springfield, Massachusetts (Dr Pack).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Storer', 'Affiliation': ''}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Szalai', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Farah', 'Affiliation': ''}, {'ForeName': 'Quinn R', 'Initials': 'QR', 'LastName': 'Pack', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000425']
3305,31957527,Efficacy of leflunomide combined with prednisone for the treatment of PLA2R-associated primary membranous nephropathy.,"Objective: To evaluate the clinical efficacy and safety of leflunomide (LEF) combined with prednisone for the treatment of PLA2R-associated primary membranous nephropathy (PMN) and changes in anti-PLA2R antibody titers after treatment. Methods: Sixty patients with nephrotic syndrome, biopsy-proven MN and anti-PLA2R antibody positivity were included in this study conducted from December 2017 to February 2019. The patients were randomly divided into an experimental group ( n = 30) and a control group ( n = 30). The patients in the experimental group were treated with LEF combined with prednisone, whereas the patients in the control group were treated with cyclophosphamide (CTX) combined with prednisone. We assessed 24-h urinary protein and serum albumin levels, kidney function markers, blood lipid levels and anti-PLA2R antibody titers before and after treatment. Adverse reactions during treatment were recorded. Results: After 16 weeks of treatment, there were 2 cases of complete remission and 6 cases of partial remission in the experimental group, with a total effective rate of 26.67%. In the control group, there were 4 cases of complete remission and 8 cases of partial remission, with a total effective rate of 40% ( p > .05). After 24 weeks of treatment, the total effective rates of the experimental and control groups were 66.67% and 76.67%, respectively ( p > .05). There were no significant differences in 24-h urinary protein, serum albumin, kidney function marker or blood lipid levels between the two groups after treatment ( p > .05). However, there were fewer adverse reactions in the experimental group than in the control group ( p < .05). After treatment, serum anti-PLA2R antibody titers were clearly decreased in patients with complete remission and partial remission ( p < .05), but these levels remained relatively high in patients without remission ( p > .05). Conclusion: LEF combined with prednisone has a certain efficacy for the treatment of PLA2R-associated PMN and provokes few adverse reactions. A large-sample randomized double-blind controlled study with a long follow-up period is needed to verify the efficacy of LEF combined with prednisone.",2020,"There were no significant differences in 24-h urinary protein, serum albumin, kidney function marker or blood lipid levels between the two groups after treatment ( p > .05).","['Sixty patients with nephrotic syndrome, biopsy-proven MN and anti-PLA2R antibody positivity were included in this study conducted from December 2017 to February 2019', 'PLA2R-associated primary membranous nephropathy']","['cyclophosphamide (CTX) combined with prednisone', 'LEF combined with prednisone', 'leflunomide (LEF) combined with prednisone', 'leflunomide combined with prednisone', 'prednisone']","['adverse reactions', 'total effective rate', 'total effective rates', '24-h urinary protein, serum albumin, kidney function marker or blood lipid levels', 'serum anti-PLA2R antibody titers', 'Adverse reactions', '24-h urinary protein and serum albumin levels, kidney function markers, blood lipid levels and anti-PLA2R antibody titers', 'partial remission', 'complete remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0017665', 'cui_str': 'Membranous Glomerulonephropathy'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0063041', 'cui_str': 'leflunomide'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005768'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",60.0,0.0269626,"There were no significant differences in 24-h urinary protein, serum albumin, kidney function marker or blood lipid levels between the two groups after treatment ( p > .05).","[{'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Nephrology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, People's Republic of China.""}, {'ForeName': 'Xueping', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Nephrology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Nephrology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, People's Republic of China.""}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Nephrology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, People's Republic of China.""}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Nephrology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, People's Republic of China.""}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Nephrology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, People's Republic of China.""}]",Renal failure,['10.1080/0886022X.2020.1713806']
3306,32072434,"Effects of dietary and physical activity interventions on generic and cancer-specific health-related quality of life, anxiety, and depression in colorectal cancer survivors: a randomized controlled trial.","PURPOSE
To assess the effects of dietary and physical activity (PA) interventions on generic and cancer-specific quality of life (QoL), anxiety, and depression levels among adult Chinese colorectal cancer (CRC) survivors.
METHODS
Two-hundred twenty-three adult CRC survivors within 1 year of completion of primary cancer treatment were randomized to receive dietary, PA or combined intervention, or usual care for a 12 monthduration, under a 2 (diet vs usual care) × 2 (PA vs usual care) factorial design. Generic and cancer-specific QoL was assessed using a Chinese version 12-Item Short Form Health Survey (SF-12) and the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) scale, respectively. Anxiety and depression was assessed using the Hospital Anxiety and Depression Scale at baseline, 6, 12, 18, and 24 months. Linear mixed models were used for examining the intervention effects.
RESULTS
Participants receiving dietary intervention experienced a significant improvement in the generic measure of QoL (SF-6D utility scores, mean difference 0.042, 95%CI 0.03 to 0.081) at 12 months, the cancer-specific QoL scores (mean difference 3.09, 95%CI 0.13 to 6.04), and levels of depression (P = 0.015) at both 12 and 24 months follow-up. Participants receiving PA intervention only demonstrated a significant improvement in SF-6D utility index (mean difference 0.039, 95%CI 0.002 to 0.077) and physical functioning (mean difference 2.85, 95%CI 1.00 to 4.70) at 6 months.
CONCLUSIONS
Dietary intervention improved the generic and cancer-specific QoL and depression in CRC survivors.
TRIAL REGISTRATION
The study was prospectively registered on 17 October 2012 at ClinicalTrials.gov (NCT01708824).
IMPLICATIONS FOR CANCER SURVIVORS
CRC survivors can benefit from dietary interventions in alleviating depression and improving overall health-related QoL.",2020,"Participants receiving PA intervention only demonstrated a significant improvement in SF-6D utility index (mean difference 0.039, 95%CI 0.002 to 0.077) and physical functioning (mean difference 2.85, 95%CI 1.00 to 4.70) at 6 months.
","['FOR CANCER SURVIVORS', 'Two-hundred twenty-three', 'CRC survivors', 'adult CRC survivors within 1\xa0year of completion of primary cancer treatment', 'colorectal cancer survivors', 'adult Chinese colorectal cancer (CRC) survivors']","['dietary and physical activity interventions', 'Dietary intervention', 'dietary and physical activity (PA) interventions', 'PA intervention', 'dietary intervention', 'dietary, PA or combined intervention, or usual care for a 12\xa0monthduration, under a 2 (diet vs usual care']","['Hospital Anxiety and Depression Scale', 'Anxiety and depression', 'generic and cancer-specific health-related quality of life, anxiety, and depression', 'generic measure of QoL (SF-6D utility scores', 'generic and cancer-specific QoL and depression', 'cancer-specific QoL scores', 'levels of depression', 'SF-6D utility index', 'physical functioning', 'generic and cancer-specific quality of life (QoL), anxiety, and depression levels', 'Generic and cancer-specific QoL', 'Chinese version 12-Item Short Form Health Survey (SF-12) and the Functional Assessment of Cancer Therapy-Colorectal']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}]",223.0,0.0960913,"Participants receiving PA intervention only demonstrated a significant improvement in SF-6D utility index (mean difference 0.039, 95%CI 0.002 to 0.077) and physical functioning (mean difference 2.85, 95%CI 1.00 to 4.70) at 6 months.
","[{'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Ho', 'Affiliation': 'School of Nursing, The University of Hong Kong, 4/F William M.W. Mong Block, 21 Sassoon Road, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Judy W C', 'Initials': 'JWC', 'LastName': 'Ho', 'Affiliation': 'Department of Surgery, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Daniel Y T', 'Initials': 'DYT', 'LastName': 'Fong', 'Affiliation': 'School of Nursing, The University of Hong Kong, 4/F William M.W. Mong Block, 21 Sassoon Road, Pok Fu Lam, Hong Kong. dytfong@hku.hk.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Lee', 'Affiliation': 'Centre for Sports and Exercise, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Duncan J', 'Initials': 'DJ', 'LastName': 'Macfarlane', 'Affiliation': 'Centre for Sports and Exercise, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Cerin', 'Affiliation': 'School of Public Health, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Antoinette M', 'Initials': 'AM', 'LastName': 'Lee', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Sharron', 'Initials': 'S', 'LastName': 'Leung', 'Affiliation': 'School of Nursing, Hong Kong Baptist Hospital, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Wynnie Y Y', 'Initials': 'WYY', 'LastName': 'Chan', 'Affiliation': 'School of Professional and Continuing Education, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Ivy P F', 'Initials': 'IPF', 'LastName': 'Leung', 'Affiliation': 'Department of Dietetics, Queen Elizabeth Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Sharon H S', 'Initials': 'SHS', 'LastName': 'Lam', 'Affiliation': 'Centre for Sports and Exercise, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Natural', 'Initials': 'N', 'LastName': 'Chu', 'Affiliation': 'Department of Surgery, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Aliki J', 'Initials': 'AJ', 'LastName': 'Taylor', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Kar-Keung', 'Initials': 'KK', 'LastName': 'Cheng', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00864-0']
3307,32066504,Antiviral treatment perspective against Borna disease virus 1 infection in major depression: a double-blind placebo-controlled randomized clinical trial.,"BACKGROUND
Whether Borna disease virus (BDV-1) is a human pathogen remained controversial until recent encephalitis cases showed BDV-1 infection could even be deadly. This called to mind previous evidence for an infectious contribution of BDV-1 to mental disorders. Pilot open trials suggested that BDV-1 infected depressed patients benefitted from antiviral therapy with a licensed drug (amantadine) which also tested sensitive in vitro. Here, we designed a double-blind placebo-controlled randomized clinical trial (RCT) which cross-linked depression and BDV-1 infection, addressing both the antidepressant and antiviral efficacy of amantadine.
METHODS
The interventional phase II RCT (two 7-weeks-treatment periods and a 12-months follow-up) at the Hannover Medical School (MHH), Germany, assigned currently depressed BDV-1 infected patients with either major depression (MD; N = 23) or bipolar disorder (BD; N = 13) to amantadine sulphate (PK-Merz®; twice 100 mg orally daily) or placebo treatment, and contrariwise, respectively. Clinical changes were assessed every 2-3 weeks by the 21-item Hamilton rating scale for depression (HAMD) (total, single, and combined scores). BDV-1 activity was determined accordingly in blood plasma by enzyme immune assays for antigens (PAG), antibodies (AB) and circulating immune complexes (CIC).
RESULTS
Primary outcomes (≥25% HAMD reduction, week 7) were 81.3% amantadine vs. 35.3% placebo responder (p = 0.003), a large clinical effect size (ES; Cohen's d) of 1.046, and excellent drug tolerance. Amantadine was safe reducing suicidal behaviour in the first 2 weeks. Pre-treatment maximum infection levels were predictive of clinical improvement (AB, p = 0.001; PAG, p = 0.026; HAMD week 7). Respective PAG and CIC levels correlated with AB reduction (p = 0,001 and p = 0.034, respectively). Follow-up benefits (12 months) correlated with dropped cumulative infection measures over time (p < 0.001). In vitro, amantadine concentrations as low as 2.4-10 ng/mL (50% infection-inhibitory dose) prevented infection with human BDV Hu-H1, while closely related memantine failed up to 100,000-fold higher concentration (200 μg/mL).
CONCLUSIONS
Our findings indicate profound antidepressant efficacy of safe oral amantadine treatment, paralleling antiviral effects at various infection levels. This not only supports the paradigm of a link of BDV-1 infection and depression. It provides a novel possibly practice-changing low cost mental health care perspective for depressed BDV-1-infected patients addressing global needs.
TRIAL REGISTRATION
The trial was retrospectively registered in the German Clinical Trials Registry on 04th of March 2015. The trial ID is DRKS00007649; https://www.drks.de/drks_web/setLocale_EN.do.",2020,"Respective PAG and CIC levels correlated with AB reduction (p = 0,001 and p = 0.034, respectively).",['major depression'],"['amantadine sulphate (PK-Merz®; twice 100\u2009mg orally daily) or placebo', 'amantadine', 'placebo', 'Amantadine', 'antiviral therapy with a licensed drug (amantadine']","['BDV-1 activity', 'suicidal behaviour', 'blood plasma by enzyme immune assays for antigens (PAG), antibodies (AB) and circulating immune complexes (CIC', 'excellent drug tolerance', '21-item Hamilton rating scale for depression (HAMD) (total, single, and combined scores']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0002404', 'cui_str': 'Amantadine Sulfate'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002403', 'cui_str': 'Amantadine'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy (procedure)'}, {'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0003313', 'cui_str': 'Antigen-Antibody Complex'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0013220', 'cui_str': 'Drug Tolerance'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.414154,"Respective PAG and CIC levels correlated with AB reduction (p = 0,001 and p = 0.034, respectively).","[{'ForeName': 'Detlef E', 'Initials': 'DE', 'LastName': 'Dietrich', 'Affiliation': 'Department of Psychiatry, Burghof-Clinic, Ritterstr. 19, 31737, Rinteln, Germany. detlef.dietrich@burghof-klinik.de.'}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Bode', 'Affiliation': 'Joint Senior Scientists, Freelance Bornavirus Workgroup, Beerenstr. 41, 14163, Berlin, Germany. liv.bode@web.de.'}, {'ForeName': 'Carsten W', 'Initials': 'CW', 'LastName': 'Spannhuth', 'Affiliation': 'Department of Mental Health, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hanover, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Hecker', 'Affiliation': 'Department of Biometrics, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hanover, Germany.'}, {'ForeName': 'Hanns', 'Initials': 'H', 'LastName': 'Ludwig', 'Affiliation': 'Joint Senior Scientists, Freelance Bornavirus Workgroup, Beerenstr. 41, 14163, Berlin, Germany.'}, {'ForeName': 'Hinderk M', 'Initials': 'HM', 'LastName': 'Emrich', 'Affiliation': 'Department of Mental Health, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hanover, Germany.'}]",BMC pharmacology & toxicology,['10.1186/s40360-020-0391-x']
3308,32053534,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
3309,32051822,Different Numbers of Long-Pulse 1064-nm Nd-YAG Laser Treatments for Onychomycosis: A Pilot Study.,"Purpose
To examine the benefits of different numbers of 1064-nm Nd-YAG laser treatments in patients with onychomycosis.
Methods
This was a pilot study of patients with onychomycosis who were divided into three groups: four treatment sessions (group A), eight sessions (group B), and 12 sessions (group C). Only infected nails of degrees II-III (Scoring Clinical Index for Onychomycosis) were included. Treatment was given once a week using a long-pulse Nd-YAG 1064-nm laser. Patients were followed at 8, 16, and 24 weeks after the first treatment. Side effects were recorded.
Results
Treatments were completed for 442 nails in 102 patients. The efficacy rates at 8, 16, and 24 weeks were 35.5%, 38.7%, and 37.4% for group A; 31.4%, 41.7%, and 44.0% for group B; and 27.7%, 50.0%, and 55.4% for group C, respectively. There was a significant difference in the efficacy rate at 24 weeks ( P = 0.016) between groups A and C, but not for groups A vs. B, or for groups B vs. C. No difference in the efficacy rate at 8 or 16 weeks was observed among the three groups. In all three groups, the efficacy was better for degree II nails than for degree III nails (all P = 0.016) between groups A and C, but not for groups A vs. B, or for groups B vs. C. No difference in the efficacy rate at 8 or 16 weeks was observed among the three groups. In all three groups, the efficacy was better for degree II nails than for degree III nails (all.
Conclusions
The 1064-nm Nd-YAG laser had clinical benefits against onychomycosis. Higher numbers of treatments provided better long-term (24-week) benefits, but had no impact on the short-term outcomes. The efficacy of laser treatment on degree II onychomycosis was better than for degree III.",2020,"There was a significant difference in the efficacy rate at 24 weeks ( P = 0.016) between groups A and C, but not for groups A vs. B, or for groups B vs. C.","['patients with onychomycosis', '442 nails in 102 patients', 'Onychomycosis', 'Only infected nails of degrees II-III']","['laser treatment', '1064-nm Nd-YAG laser treatments']","['efficacy rates', 'Side effects', 'degree II onychomycosis', 'efficacy rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040261', 'cui_str': 'Tinea Unguium'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392276', 'cui_str': 'Nd-YAG Lasers'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0040261', 'cui_str': 'Tinea Unguium'}]",,0.0273561,"There was a significant difference in the efficacy rate at 24 weeks ( P = 0.016) between groups A and C, but not for groups A vs. B, or for groups B vs. C.","[{'ForeName': 'Rui-Na', 'Initials': 'RN', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, Beijng 100050, China.'}, {'ForeName': 'Feng-Lin', 'Initials': 'FL', 'LastName': 'Zhuo', 'Affiliation': 'Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, Beijng 100050, China.'}, {'ForeName': 'Dong-Kun', 'Initials': 'DK', 'LastName': 'Wang', 'Affiliation': 'Department of Dermatology, Beijing Evercare Jianxiang Hospital, China.'}, {'ForeName': 'Li-Zhi', 'Initials': 'LZ', 'LastName': 'Ma', 'Affiliation': ""Department of Dermatology, Chengdu Second People's Hospital, China.""}, {'ForeName': 'Jun-Ying', 'Initials': 'JY', 'LastName': 'Zhao', 'Affiliation': 'Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, Beijng 100050, China.'}, {'ForeName': 'Lin-Feng', 'Initials': 'LF', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, Beijng 100050, China.'}]",BioMed research international,['10.1155/2020/1216907']
3310,31356508,Physical Activity Is Higher in Patients with LVADs Compared to Chronic Heart Failure.,"PURPOSE
Left ventricular assist devices (LVADs) are associated with an increased aerobic capacity in patients with chronic heart failure (CHF). However, studies evaluating the impact of LVAD implantation on physical activity (PA) are lacking. The aim of this study was to compare daily PA levels in participants with LVADs with well-matched CHF participants.
METHODS
Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation. Participants underwent a cardiopulmonary exercise test to determine peak oxygen consumption (V[Combining Dot Above]O2 peak). PA was monitored continuously for seven consecutive days with an Actiheart monitor.
RESULTS
V[Combining Dot Above]O2 peak in the CHF group (12.3 ± 3.5 ml·kg·min) was not significantly different to the LVAD group prior to LVAD implantation (10.4 ± 2.1 ml·kg·min), but was lower than in the LVAD group following implantation (15.8 ± 4.3 ml·kg·min; p < 0.05). PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001). LVAD participants spent more time performing moderate intensity PA than their CHF counterparts, 26 (24-40) [median (IQR)] vs. 12 (9-16) min/day; p < 0.001. PA was correlated with V[Combining Dot Above]O2 peak (r = 0.582; p = 0.001) across participants in the CHF and LVAD groups.
CONCLUSION
Higher levels of PA were observed in participants with LVAD compared with patients with advanced CHF. This may be due to a higher V[Combining Dot Above]O2 peak, resulting in an improved capacity to perform activities of daily living with less symptoms.",2019,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"['Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation', 'patients with chronic heart failure (CHF', 'participants with LVADs with well-matched CHF participants']","['LVAD implantation', 'Left ventricular assist devices (LVADs', 'cardiopulmonary exercise test', 'LVAD']","['Dot Above]O2 peak', 'time performing moderate intensity PA', 'V[Combining Dot Above]O2 peak', 'PA', 'peak oxygen consumption (V[Combining Dot Above]O2 peak', 'Physical Activity', 'aerobic capacity', 'daily PA levels', 'Higher levels of PA']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",16.0,0.0464878,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Moreno-Suarez', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Liew', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Dembo', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Larbalestier', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002104']
3311,32053538,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
3312,31805012,Oral N-acetylcysteine improves cone function in retinitis pigmentosa patients in phase I trial.,"BACKGROUNDIn retinitis pigmentosa (RP), rod photoreceptors degenerate from 1 of many mutations, after which cones are compromised by oxidative stress. N-acetylcysteine (NAC) reduces oxidative damage and increases cone function/survival in RP models. We tested the safety, tolerability, and visual function effects of oral NAC in RP patients.METHODSSubjects (n = 10 per cohort) received 600 mg (cohort 1), 1200 mg (cohort 2), or 1800 mg (cohort 3) NAC bid for 12 weeks and then tid for 12 weeks. Best-corrected visual acuity (BCVA), macular sensitivity, ellipsoid zone (EZ) width, and aqueous NAC were measured. Linear mixed-effects models were used to estimate the rates of changes during the treatment period.RESULTSThere were 9 drug-related gastrointestinal adverse events that resolved spontaneously or with dose reduction (maximum tolerated dose 1800 mg bid). During the 24-week treatment period, mean BCVA significantly improved at 0.4 (95% CI: 0.2-0.6, P < 0.001), 0.5 (95% CI: 0.3-0.7, P < 0.001), and 0.2 (95% CI: 0.02-0.4, P = 0.03) letters/month in cohorts 1, 2, and 3, respectively. There was no significant improvement in mean sensitivity over time in cohorts 1 and 2, but there was in cohort 3 (0.15 dB/month, 95% CI: 0.04-0.26). There was no significant change in mean EZ width in any cohort.CONCLUSIONOral NAC is safe and well tolerated in patients with moderately advanced RP and may improve suboptimally functioning macular cones. A randomized, placebo-controlled trial is needed to determine if oral NAC can provide long-term stabilization and/or improvement in visual function in patients with RP.TRIAL REGISTRATIONNCT03063021.FUNDINGMr. and Mrs. Robert Wallace, Mr. and Mrs. Jonathan Wallace, Rami and Eitan Armon, Marc Sumerlin, Cassandra Hanley, and Nacuity Pharmaceuticals, Inc.",2020,RESULTSThere were 9 drug-related gastrointestinal adverse events that resolved spontaneously or with dose reduction (maximum tolerated dose 1800 mg bid).,"['retinitis pigmentosa (RP', 'RP patients', 'patients with moderately advanced RP', 'patients with RP.TRIAL REGISTRATIONNCT03063021.FUNDINGMr', 'retinitis pigmentosa patients']","['Oral N-acetylcysteine', 'placebo', 'oral NAC', 'NAC', 'N-acetylcysteine (NAC']","['gastrointestinal adverse events', 'mean sensitivity', 'cone function', 'visual function', 'Best-corrected visual acuity (BCVA), macular sensitivity, ellipsoid zone (EZ) width, and aqueous NAC', 'mean BCVA', 'safety, tolerability, and visual function effects', 'mean EZ width', 'safe and well tolerated']","[{'cui': 'C0035334', 'cui_str': 'Pigmentary Retinopathy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0393983', 'cui_str': 'Cerebellar Herniation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.250889,RESULTSThere were 9 drug-related gastrointestinal adverse events that resolved spontaneously or with dose reduction (maximum tolerated dose 1800 mg bid).,"[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Campochiaro', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Iftikhar', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Gulnar', 'Initials': 'G', 'LastName': 'Hafiz', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Anam', 'Initials': 'A', 'LastName': 'Akhlaq', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Tsai', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Wehling', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Wall', 'Affiliation': 'Nacuity Pharmaceuticals, Inc., Fort Worth, Texas, USA.'}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Singh', 'Affiliation': 'Wilmer Eye Institute and.'}, {'ForeName': 'Xiangrong', 'Initials': 'X', 'LastName': 'Kong', 'Affiliation': 'Wilmer Eye Institute and.'}]",The Journal of clinical investigation,['10.1172/JCI132990']
3313,32046671,"Protocol for Correcting Residual Errors with Spectral, ULtrasound, Traditional Speech therapy Randomized Controlled Trial (C-RESULTS RCT).","BACKGROUND
Speech sound disorder in childhood poses a barrier to academic and social participation, with potentially lifelong consequences for educational and occupational outcomes. While most speech errors resolve by the late school-age years, between 2 and 5% of speakers exhibit residual speech errors (RSE) that persist through adolescence or even adulthood. Previous findings from small-scale studies suggest that interventions incorporating visual biofeedback can outperform traditional motor-based treatment approaches for children with RSE, but this question has not been investigated in a well-powered randomized controlled trial.
METHODS/DESIGN
This project, Correcting Residual Errors with Spectral, ULtrasound, Traditional Speech therapy Randomized Controlled Trial (C-RESULTS RCT), aims to treat 110 children in a parallel randomized controlled clinical trial comparing biofeedback and non-biofeedback interventions for RSE affecting the North American English rhotic sound /ɹ/. Eligible children will be American English speakers, aged 9-15 years, who exhibit RSE affecting /ɹ/ but otherwise show typical cognitive-linguistic and hearing abilities. Participants will be randomized, with stratification by site (Syracuse University or Montclair State University) and pre-treatment speech production ability, to receive either a motor-based treatment consistent with current best practices in speech therapy (40% of participants) or treatment incorporating visual biofeedback (60% of participants). Within the biofeedback condition, participants will be assigned in equal numbers to receive biofeedback in the form of a real-time visual display of the acoustic signal of speech or ultrasound imaging of the tongue during speech. The primary outcome measure will assess changes in the acoustics of children's production of /ɹ/ during treatment, while a secondary outcome measure will use blinded listeners to evaluate changes in the perceived accuracy of /ɹ/ production after the completion of all treatment. These measures will allow the treatment conditions to be compared with respect to both efficacy and efficiency.
DISCUSSION
By conducting the first well-powered randomized controlled trial comparing treatment with and without biofeedback, this study aims to provide high-quality evidence to guide treatment decisions for children with RSE.
TRIAL REGISTRATION
ClinicalTrials.gov identifier NCT03737318, November 9, 2018.",2020,"The primary outcome measure will assess changes in the acoustics of children's production of /ɹ/ during treatment, while a secondary outcome measure will use blinded listeners to evaluate changes in the perceived accuracy of /ɹ/ production after the completion of all treatment.","['Eligible children will be American English speakers, aged 9-15\u2009years, who exhibit RSE affecting /ɹ/ but otherwise show typical cognitive-linguistic and hearing abilities', '110 children', 'children with RSE']","['pre-treatment speech production ability, to receive either a motor-based treatment consistent with current best practices in speech therapy (40% of participants) or treatment incorporating visual biofeedback', 'visual biofeedback', 'biofeedback and non-biofeedback interventions']","[""acoustics of children's production of /ɹ/ during treatment""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0033268'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0037831', 'cui_str': 'Speech Therapy'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}]","[{'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033268'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.187763,"The primary outcome measure will assess changes in the acoustics of children's production of /ɹ/ during treatment, while a secondary outcome measure will use blinded listeners to evaluate changes in the perceived accuracy of /ɹ/ production after the completion of all treatment.","[{'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'McAllister', 'Affiliation': 'Department of Communicative Sciences and Disorders, New York University, New York, NY, USA.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Preston', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, 621 Skytop Rd, Suite 1200, Syracuse, NY, 13244, USA. jopresto@syr.edu.'}, {'ForeName': 'Elaine R', 'Initials': 'ER', 'LastName': 'Hitchcock', 'Affiliation': 'Department of Communication Sciences & Disorders, Montclair State University, Bloomfield, NJ, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Department of Applied Statistics, Social Science, and the Humanities, New York University, New York, NY, USA.'}]",BMC pediatrics,['10.1186/s12887-020-1941-5']
3314,32067341,Implementation of a very low calorie diet program into the pre-operative model of care for obese general elective surgery patients: Outcomes of a feasibility randomised control trial.,"AIM
The present article aimed to evaluate the feasibility of implementing a very low calorie diet (VLCD) weight loss program into the pre-operative model of care for elective general surgery patients with obesity.
METHODS
A prospective, randomised control trial of adults with obesity awaiting elective general surgery was conducted at an outpatient clinic at a tertiary hospital. Patients were randomised to the intervention group, an 8-week VLCD program incorporating Optifast (Nestle Health, Germany) shakes, or to standard care (generic healthy eating information). Data were collected at baseline, week 8 and at 30 days post-surgery. The primary outcome of the study was feasibility, which was evaluated through demand, practicality, integration and acceptability measures.
RESULTS
Forty-six participants (M 17: F 23, mean age 51.6 (13.1) years) with a mean body mass index ≥ 30 kg/m 2 (40.5 kg/m 2 (5.9)) were recruited. There was a higher mean weight loss in the intervention group (n = 23) compared to the control group (n = 14) (-6.5 vs +0.15 kg; P = <.001), with no excessive loss of muscle mass (MM), measured by bioelectrical impedance analysis. The reduction in waist circumference was greater for the intervention (n = 21) compared to control group (n = 5) (-6.11 vs +1.36 cm; P = .003). Quality of life increased significantly in the intervention group (P < .001).
CONCLUSIONS
The pre-operative VLCD program produced clinically meaningful rapid weight loss pre-surgery and improved quality of life without an excessive loss of MM.",2020,"Quality of life increased significantly in the intervention group (P < .001).
","['obese general elective surgery patients', 'adults with obesity awaiting elective general surgery was conducted at an outpatient clinic at a tertiary hospital', '30\u2009kg/m 2 (40.5\u2009kg/m 2 (5.9)) were recruited', 'elective general surgery patients with obesity', 'Forty-six participants (M 17: F 29, mean age 51.6 (13.1) years) with a mean body mass index\u2009≥']","['VLCD program incorporating Optifast (Nestle Health, Germany) shakes, or to standard care (generic healthy eating information', 'low calorie diet program', 'implementing a very low calorie diet (VLCD) weight loss program']","['quality of life without an excessive loss of MM', 'demand, practicality, integration and acceptability measures', 'Quality of life', 'reduction in waist circumference', 'mean weight loss']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0452268', 'cui_str': 'Very low energy diet (finding)'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C0034380'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",46.0,0.0920447,"Quality of life increased significantly in the intervention group (P < .001).
","[{'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Hollis', 'Affiliation': 'The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Franz', 'Affiliation': 'Department of General Surgery, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Bauer', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Bell', 'Affiliation': 'The Prince Charles Hospital, Brisbane, Australia.'}]",Nutrition & dietetics: the journal of the Dietitians Association of Australia,['10.1111/1747-0080.12601']
3315,31900959,Regorafenib in Chinese patients with metastatic colorectal cancer: Subgroup analysis of the phase 3 CONCUR trial.,"BACKGROUND AND AIM
In the phase 3 CONCUR trial (NCT01584830), regorafenib improved overall survival (OS) versus placebo in Asian patients with treatment-refractory metastatic colorectal cancer (mCRC). We conducted a post hoc subgroup analysis of Chinese patients in CONCUR.
METHODS
Adults with mCRC progressing despite at least two prior treatment regimens and Eastern Cooperative Oncology Group performance status 0-1 were randomized 2:1 to regorafenib 160 mg once daily or placebo for the first 3 weeks of each 4-week cycle. Dose modifications were permitted. The primary endpoint was OS. Secondary endpoints included progression-free survival, objective overall response, disease control rate, and safety.
RESULTS
A total of 172 Chinese patients were randomized and treated (regorafenib n = 112, placebo n = 60). OS was significantly improved with regorafenib versus placebo (8.4 vs 6.2 months, respectively; hazard ratio [HR] 0.56, 95% CI 0.39-0.80; one-sided P = 0.000632), as was progression-free survival (HR 0.32, 95% CI 0.22-0.47; one-sided P < 0.000001). The most common drug-related grade ≥ 3 treatment-emergent adverse events (TEAEs; regorafenib, placebo) were hand-foot skin reaction (19%, 0%), hypertension (13%, 3%), hypophosphatemia (7%, 0%), increased alanine aminotransferase (6%, 0%), and increased aspartate aminotransferase (5%, 0%). In patients receiving regorafenib and placebo, respectively, TEAEs led to treatment discontinuation in 14% and 7%, dose reduction in 39% and 0%, and dose interruption in 64% and 20%.
CONCLUSIONS
This retrospective analysis showed that regorafenib provided an OS benefit over placebo for Chinese patients with previously treated mCRC. TEAEs were consistent with the regorafenib safety profile and manageable with treatment modifications.",2020,"OS was significantly improved with regorafenib versus placebo (8.4 vs 6.2 months, respectively; hazard ratio [HR]","['Chinese patients with previously treated mCRC', 'Adults with mCRC progressing despite at least two prior treatment regimens and Eastern Cooperative Oncology Group performance status 0-1', 'Chinese patients in CONCUR', 'Asian patients with treatment-refractory metastatic colorectal cancer (mCRC', 'Chinese patients with metastatic colorectal cancer', '172 Chinese patients']","['regorafenib', 'regorafenib 160 mg once daily or placebo', 'placebo', 'Regorafenib', 'regorafenib versus placebo', 'regorafenib n=112, placebo', 'regorafenib and placebo']","['alanine aminotransferase', 'hazard ratio [HR', 'hypertension', 'foot skin reaction', 'aspartate aminotransferase', 'progression-free survival (PFS), objective overall response, disease control rate, and safety', 'overall survival (OS', 'hypophosphatemia', 'OS']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}]",172.0,0.677644,"OS was significantly improved with regorafenib versus placebo (8.4 vs 6.2 months, respectively; hazard ratio [HR]","[{'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'The 307 Hospital of PLA Cancer Center, Beijing, China.'}, {'ForeName': 'Rui-Hua', 'Initials': 'RH', 'LastName': 'Xu', 'Affiliation': 'Sun Yat-Sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""Chinese People's Liberation Army Cancer Center of Nanjing Bayi Hospital, Nanjing, China.""}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Sir Run Run Shaw Hospital, Hangzhou, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Yihebali', 'Initials': 'Y', 'LastName': 'Chi', 'Affiliation': 'Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Shanghai First People's Hospital, Shanghai, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Bi', 'Affiliation': 'West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Provincial Tumor Hospital, Changchun, China.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Guangdong General Hospital, Guangdong, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ba', 'Affiliation': 'Tianjin Medical University Cancer Hospital, Tianjin, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Affiliated Hospital of Medical College, Qingdao University, Shandong, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""The First Affiliated Hospital of the 4th Military Medical University, Xi'an, China.""}, {'ForeName': 'Thomas C C', 'Initials': 'TCC', 'LastName': 'Yau', 'Affiliation': 'Queen Mary Hospital University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Brigette B', 'Initials': 'BB', 'LastName': 'Ma', 'Affiliation': 'Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Kun-Huei', 'Initials': 'KH', 'LastName': 'Yeh', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Jen-Kou', 'Initials': 'JK', 'LastName': 'Lin', 'Affiliation': 'Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kappeler', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Shapiro', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, New Jersey, USA.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Kalmus', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Tongji University Shanghai East Hospital, Shanghai, China.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.14974']
3316,31290948,Efficacy of Short-term Treatment of Internet and Computer Game Addiction: A Randomized Clinical Trial.,"Importance
Internet and computer game addiction represent a growing mental health concern, acknowledged by the World Health Organization.
Objective
To determine whether manualized cognitive behavioral therapy (CBT), using short-term treatment for internet and computer game addiction (STICA), is efficient in individuals experiencing internet and computer game addiction.
Design, Setting, and Participants
A multicenter randomized clinical trial was conducted in 4 outpatient clinics in Germany and Austria from January 24, 2012, to June 14, 2017, including follow-ups. Blinded measurements were conducted. A consecutive sample of 143 men was randomized to the treatment group (STICA; n = 72) or wait-list control (WLC) group (n = 71). Main inclusion criteria were male sex and internet addiction as the primary diagnosis. The STICA group had an additional 6-month follow-up (n = 36). Data were analyzed from November 2018 to March 2019.
Interventions
The manualized CBT program aimed to recover functional internet use. The program consisted of 15 weekly group and up to 8 two-week individual sessions.
Main Outcomes and Measures
The predefined primary outcome was the Assessment of Internet and Computer Game Addiction Self-report (AICA-S). Secondary outcomes were self-reported internet addiction symptoms, time spent online on weekdays, psychosocial functioning, and depression.
Results
A total of 143 men (mean [SD] age, 26.2 [7.8] years) were analyzed based on intent-to-treat analyses. Of these participants, 50 of 72 men (69.4%) in the STICA group showed remission vs 17 of 71 men (23.9%) in the WLC group. In logistic regression analysis, remission in the STICA vs WLC group was higher (odds ratio, 10.10; 95% CI, 3.69-27.65), taking into account internet addiction baseline severity, comorbidity, treatment center, and age. Compared with the WLC groups, effect sizes at treatment termination of STICA were d = 1.19 for AICA-S, d = 0.88 for time spent online on weekdays, d = 0.64 for psychosocial functioning, and d = 0.67 for depression. Fourteen adverse events and 8 serious adverse events occurred. A causal relationship with treatment was considered likely in 2 AEs, one in each group.
Conclusions and Relevance
Short-term treatment for internet and computer game addiction is a promising, manualized, short-term CBT for a broad range of internet addictions in multiple treatment centers. Further trials investigating the long-term efficacy of STICA and addressing specific groups and subgroups compared with active control conditions are required.
Trial Registration
ClinicalTrials.gov identifier: NCT01434589.",2019,"In logistic regression analysis, remission in the STICA vs WLC group was higher (odds ratio, 10.10; 95% CI, 3.69-27.65), taking into account internet addiction baseline severity, comorbidity, treatment center, and age.","['individuals experiencing internet and computer game addiction', 'A consecutive sample of 143 men', 'A total of\u2009143 men (mean [SD] age, 26.2 [7.8] years) were analyzed based on intent-to-treat analyses', 'Game Addiction', '4 outpatient clinics in Germany and Austria from January 24, 2012, to June 14, 2017, including follow-ups']","['WLC', 'Internet and Computer', 'wait-list control (WLC', 'STICA', 'manualized cognitive behavioral therapy (CBT), using short-term treatment for internet and computer game addiction (STICA']","['Assessment of Internet and Computer Game Addiction Self-report (AICA-S', 'self-reported internet addiction symptoms, time spent online on weekdays, psychosocial functioning, and depression']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.0840233,"In logistic regression analysis, remission in the STICA vs WLC group was higher (odds ratio, 10.10; 95% CI, 3.69-27.65), taking into account internet addiction baseline severity, comorbidity, treatment center, and age.","[{'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Wölfling', 'Affiliation': 'Outpatient Clinic for Behavioral Addictions, Department of Psychosomatic Medicine and Psychotherapy, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Kai W', 'Initials': 'KW', 'LastName': 'Müller', 'Affiliation': 'Outpatient Clinic for Behavioral Addictions, Department of Psychosomatic Medicine and Psychotherapy, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dreier', 'Affiliation': 'Outpatient Clinic for Behavioral Addictions, Department of Psychosomatic Medicine and Psychotherapy, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ruckes', 'Affiliation': 'Interdisciplinary Center for Clinical Trials Mainz, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Deuster', 'Affiliation': 'Interdisciplinary Center for Clinical Trials Mainz, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Batra', 'Affiliation': 'University Hospital of Tübingen, Department of Psychiatry and Psychotherapy, Section for Addiction Research and Medicine, Tübingen, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Mann', 'Affiliation': 'Medical Faculty Mannheim, Department of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Musalek', 'Affiliation': 'Department of Psychiatry, Anton Proksch Institute, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schuster', 'Affiliation': 'Department of Psychiatry, Anton Proksch Institute, Vienna, Austria.'}, {'ForeName': 'Tagrid', 'Initials': 'T', 'LastName': 'Lemenager', 'Affiliation': 'Medical Faculty Mannheim, Department of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hanke', 'Affiliation': 'University Hospital of Tübingen, Department of Psychiatry and Psychotherapy, Section for Addiction Research and Medicine, Tübingen, Germany.'}, {'ForeName': 'Manfred E', 'Initials': 'ME', 'LastName': 'Beutel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.1676']
3317,32058628,Preventing postpartum depressive symptoms using an educational video on infant crying: A cluster randomized controlled trial.,"BACKGROUND
The aim of this study was to examine the impact of watching an educational video on infant crying within 1 week of age after delivery at maternity wards to reduce the prevalence of postpartum depressive symptoms at 1 month after giving birth.
METHODS
The study design was a cluster randomized controlled trial. The intervention hospitals were randomly assigned, stratified by area and function of the hospital. Participants included 47 obstetrics hospitals or clinics out of 150 hospitals or clinics in Osaka Prefecture, Japan. In total, 44 hospitals or clinics completed the trial and 2,601 (intervention group = 1,040, control group = 1,561) caregivers responded to the questionnaire on postpartum depression (response rate: 55.1%). Mothers in the intervention group watched an educational video, within 1 week of age, during hospitalization at maternity wards. Primary outcome in this study was postpartum depression assessed by the Edinburgh Postnatal Depression Scale as 9+ and assessed via questionnaire at a 1-month health checkup.
RESULTS
In the intervention group, 142 (13.7%) mothers reported postpartum depression compared to 250 (16.0%) in the control group. Intention-to-treat analysis showed no significant difference in the prevalence of postpartum depression between the groups. However, among young mothers (<25 years), the analysis showed a 67.0% reduction in postpartum depression (odds ratio: 0.33, 95% CI: 0.15-0.72).
CONCLUSIONS
Watching an educational video on infant crying within 1 week after delivery at maternity wards did not reduce postpartum depression at 1 month after giving birth, but it was effective for young mothers aged <25 years.",2020,"Watching an educational video on infant crying within 1 week after delivery at maternity wards did not reduce postpartum depression at 1 month after giving birth, but it was effective for young mothers aged <25 years.","['young mothers aged <25 years', 'In total, 44 hospitals or clinics completed the trial and 2,601 (intervention group\u2009=\u20091,040, control group\u2009=\u20091,561) caregivers responded to the questionnaire on postpartum depression (response rate: 55.1', 'on infant crying', 'Participants included 47 obstetrics hospitals or clinics out of 150 hospitals or clinics in Osaka Prefecture, Japan', 'infant crying within 1 week of age after delivery at maternity wards to reduce the prevalence of postpartum depressive symptoms at 1 month after giving birth']","['Watching an educational video', 'educational video', 'watching an educational video']","['postpartum depressive symptoms', 'prevalence of postpartum depression', 'postpartum depression assessed by the Edinburgh Postnatal Depression Scale as 9+ and assessed via questionnaire at a 1-month health checkup', 'postpartum depression']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.203418,"Watching an educational video on infant crying within 1 week after delivery at maternity wards did not reduce postpartum depression at 1 month after giving birth, but it was effective for young mothers aged <25 years.","[{'ForeName': 'Satomi', 'Initials': 'S', 'LastName': 'Doi', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Isumi', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Mitsuda', 'Affiliation': 'Department of Maternal Fetal Medicine, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan.'}]",Depression and anxiety,['10.1002/da.23002']
3318,32038104,"Comparison of Sufentanil- and Fentanyl-based Intravenous Patient-controlled Analgesia on Postoperative Nausea and Vomiting after Laparoscopic Nephrectomy: A Prospective, Double-blind, Randomized-controlled Trial.","Background : The incidence of postoperative nausea and vomiting (PONV) remains high. The effects of sufentanil for PONV is not firmly confirmed. The aim of this study was to compare the effect of sufentanil- and fentanyl-based intravenous patient-controlled analgesia (IV-PCA) on the incidence of PONV after laparoscopic nephrectomy. Methods : Eighty-six patients were randomly allocated to receive either the sufentanil (n =43) or fentanyl (n =43). IV-PCA was prepared using either sufentanil 3 µg/kg or fentanyl 20 µg/kg, ramosetron 0.3 mg, and ketorolac 120 mg. The primary outcome of was the incidence of PONV during 24 h after post anesthesia care unit (PACU) discharge. The secondary outcomes were the modified Rhodes index and patient satisfaction scores at 24 h after PACU discharge, need for rescue antiemetics, pain score, need for additional analgesics, and cumulative consumption of IV-PCA Results : The incidence of PONV was comparable between the sufentanil and fentanyl groups (64.3% vs. 65%, p = 0.946; respectively). The number of patients who required antiemetics (p = 0.946) and the modified Rhodes index at 24 h after post-anesthesia care unit discharge (p = 0.668) were also comparable in both groups. No significant differences were found in the secondary outcomes, including the analgesic profiles and adverse events between the groups. Conclusions : In conclusion, sufentanil- and fentanyl-based IV-PCA showed similar incidence of PONV with comparable analgesic effects after laparoscopic nephrectomy. Based on these results, we suggest that sufentanil and fentanyl may provide comparable effects for IV-PCA after laparoscopic nephrectomy.",2020,The number of patients who required antiemetics (p = 0.946) and the modified Rhodes index at 24 h after post-anesthesia care unit discharge (p = 0.668) were also comparable in both groups.,"['Methods : Eighty-six patients', 'after Laparoscopic Nephrectomy']","['sufentanil', 'Sufentanil- and Fentanyl-based Intravenous Patient-controlled Analgesia', 'sufentanil 3 µg/kg or fentanyl 20 µg/kg, ramosetron 0.3 mg, and ketorolac', 'sufentanil and fentanyl', 'sufentanil- and fentanyl-based intravenous patient-controlled analgesia (IV-PCA', ' ', 'fentanyl']","['postoperative nausea and vomiting (PONV', 'analgesic profiles and adverse events', 'modified Rhodes index and patient satisfaction scores at 24 h after PACU discharge, need for rescue antiemetics, pain score, need for additional analgesics, and cumulative consumption of IV-PCA Results ', 'Postoperative Nausea and Vomiting', 'incidence of PONV', 'incidence of PONV during 24 h after post anesthesia care unit (PACU) discharge']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0526950', 'cui_str': 'ramosetron'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0030625', 'cui_str': 'PCA'}]","[{'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0454812', 'cui_str': 'Rhodes (geographic location)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]",86.0,0.453282,The number of patients who required antiemetics (p = 0.946) and the modified Rhodes index at 24 h after post-anesthesia care unit discharge (p = 0.668) were also comparable in both groups.,"[{'ForeName': 'Hye-Mi', 'Initials': 'HM', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hae Keum', 'Initials': 'HK', 'LastName': 'Kil', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Bon Nyeo', 'Initials': 'BN', 'LastName': 'Koo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Min Sup', 'Initials': 'MS', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin Ha', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",International journal of medical sciences,['10.7150/ijms.39374']
3319,31919035,Predictive modelling of the physical demands during training and competition in professional soccer players.,"OBJECTIVES
The present study aimed to predict the cut-off point-values that best differentiate the physical demands of training and competition tasks including friendly matches (FM), small sided games (SSG), large sided games (LSG), mini-goal games (MG) and ball circuit-training (CT) in professional soccer players.
DESIGN
Experimental randomized controlled trial.
METHODS
Fourteen professional players participated in all tasks with the CT, SSG and MG consisting of 8 repetitions of 4-min game play, interspersed by 2-min of active recovery. The training data were compared to the first 32-min of the LSG and two competitive FM per player. All movement patterns from walking to sprint running were recorded using 10Hz GPS devices while player perception of exertion was recorded via a visual analogue scale, post-task. Decision tree induction was applied to the dataset to assess the cut-off point-values from four training drills (SSG, LSG, MG, and CT) and FM for every parameter combination.
RESULTS
Distance covered during jogging (2.3-3.3m/s; >436m), number of decelerations (≤730.5) and accelerations (≤663), and maximum velocity reached (>5.48m/s) characterized the physical demands during competition (FM) with great variability amongst training drills.
CONCLUSION
The use of these novel, cut-off points may aid coaches in the design and use of training drills to accurately prepare athletes for soccer competition.",2020,"The use of these novel, cut-off points may aid coaches in the design and use of training drills to accurately prepare athletes for soccer competition.","['professional soccer players', 'Fourteen professional players participated in all tasks with the']","['CT, SSG and MG consisting of 8 repetitions of 4-min game play, interspersed by 2-min of active recovery', 'training and competition tasks including friendly matches (FM), small sided games (SSG), large sided games (LSG), mini-goal games (MG) and ball circuit-training (CT']","['number of decelerations (≤730.5) and accelerations (≤663), and maximum velocity']","[{'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]",14.0,0.0367734,"The use of these novel, cut-off points may aid coaches in the design and use of training drills to accurately prepare athletes for soccer competition.","[{'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Giménez', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain. Electronic address: jesus.gimenezdegalanes@universidadeuropea.es.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Jiménez-Linares', 'Affiliation': 'School Computer Science, Department of Information Technologies and Systems, University of Castilla-la Mancha, Spain.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Leicht', 'Affiliation': 'Sport and Exercise Science, James Cook University, Australia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Gómez', 'Affiliation': 'Faculty of Physical Activity and Sport Sciences, Polytechnic University of Madrid, Spain.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2019.12.008']
3320,31930360,Effectiveness of Combined Behavioral and Drug Therapy for Overactive Bladder Symptoms in Men: A Randomized Clinical Trial.,"Importance
First-line behavioral and drug therapies for overactive bladder (OAB) symptoms in men are effective but not usually curative.
Objective
To determine whether combining behavioral and drug therapies improves outcomes compared with each therapy alone for OAB in men and to compare 3 sequences for implementing combined therapy.
Design, Setting, and Participants
In this 3-site, 2-stage, 3-arm randomized clinical trial, participants were randomized to 6 weeks of behavioral therapy alone, drug therapy alone, or combined therapy followed by step-up to 6 weeks of combined therapy for all groups. Participants were recruited from 3 outpatient clinics and included community-dwelling men 40 years or older with urinary urgency and 9 or more voids per 24 hours. Data were collected from July 2010 to July 2015 and analyzed from April 2016 to September 2019.
Interventions
Behavioral therapy consisted of pelvic floor muscle training with urge suppression strategies and delayed voiding. Drug therapy included an antimuscarinic (sustained-release tolterodine, 4 mg) plus an α-blocker (tamsulosin, 0.4 mg).
Main Outcomes and Measures
Seven-day bladder diaries completed before and after each 6-week treatment stage were used to calculate reduction in frequency of urination (primary outcome) and other symptoms (ie, urgency, urgency incontinence, and nocturia). Other secondary outcomes included validated patient global ratings of improvement and satisfaction, Overactive Bladder Questionnaire score, and International Prostate Symptom Score.
Results
Of the 204 included men, 133 (65.2%) were white, and the mean (SD) age was 64.1 (11.1) years. A total of 21 men discontinued treatment and 183 completed treatment. Mean (SD) voids per 24 hours decreased significantly in all 3 groups from baseline to 6-week follow-up (behavioral therapy: 11.7 [2.4] vs 8.8 [2.1]; change, 2.9 [2.4]; percentage change, 24.7%; P < .001; drug therapy: 11.8 [2.5] vs 10.3 [2.7]; change, 1.5 [2.3]; percentage change, 12.7%; P < .001; combined therapy: 11.8 [2.4] vs 8.2 [2.3]; change, 3.6 [2.1]; percentage change, 30.5%; P < .001). Intention-to-treat analyses indicated that posttreatment mean (SD) voiding frequencies were significantly lower in those receiving combined therapy compared with drug therapy alone (8.2 [2.3] vs 10.3 [2.7]; P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001). At 12-week follow-up, after all groups had received combined therapy, improvements in mean (SD) voids per 24 hours were also greatest for those receiving initial combined therapy compared with baseline (behavioral therapy: 11.7 [2.4] vs 8.0 [2.2]; change, 3.7 [2.3]; percentage change, 31.6%; P < .001; drug therapy: 11.8 [2.5] vs 8.6 [2.3]; change, 3.2 [2.5]; percentage change, 27.1%; P < .001; combined therapy: 11.8 [2.4] vs 8.0 [2.2]; change, 3.8 [2.1]; percentage change, 32.2%; P < .001), but there were no statistically significant group differences on primary or secondary measures.
Conclusions and Relevance
Combining behavioral and drug therapy yields greater improvements in OAB symptoms than drug therapy alone but not behavioral therapy alone. When using a stepped approach, it is reasonable to begin with behavioral therapy alone.
Trial Registration
ClinicalTrials.gov identifier: NCT01175382.",2020,P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001).,"['204 included men, 133 (65.2%) were white, and the mean (SD) age was 64.1 (11.1) years', 'Overactive Bladder Symptoms in Men', 'Data were collected from July 2010 to July 2015 and analyzed from April 2016 to September 2019', 'Participants were recruited from 3 outpatient clinics and included community-dwelling men 40 years or older with urinary urgency and 9 or more voids per 24 hours', '21 men discontinued treatment and 183 completed treatment']","['antimuscarinic (sustained-release tolterodine, 4 mg) plus an α-blocker (tamsulosin, 0.4 mg', 'behavioral therapy alone, drug therapy alone, or combined therapy followed by step-up to 6 weeks of combined therapy', 'Combined Behavioral and Drug Therapy', 'pelvic floor muscle training with urge suppression strategies and delayed voiding']","['Mean (SD) voids per 24 hours', 'mean (SD) voids', 'frequency of urination (primary outcome) and other symptoms (ie, urgency, urgency incontinence, and nocturia', 'OAB symptoms', 'validated patient global ratings of improvement and satisfaction, Overactive Bladder Questionnaire score, and International Prostate Symptom Score', 'posttreatment mean (SD) voiding frequencies', 'Main Outcomes and Measures\n\n\nSeven-day bladder diaries', 'overactive bladder (OAB) symptoms']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate (finding)'}, {'cui': 'C0456696', 'cui_str': '/24h'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C4521482', 'cui_str': 'Antimuscarinic'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0033972', 'cui_str': 'Psychotherapy, Multiple'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0454366', 'cui_str': 'Step ups (regime/therapy)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456696', 'cui_str': '/24h'}, {'cui': 'C2584336', 'cui_str': 'Frequency of urination (observable entity)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart (procedure)'}]",,0.0524237,P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001).,"[{'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Kraus', 'Affiliation': 'Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio.'}, {'ForeName': 'Theodore M', 'Initials': 'TM', 'LastName': 'Johnson', 'Affiliation': 'Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Atlanta, Georgia.'}, {'ForeName': 'Alayne D', 'Initials': 'AD', 'LastName': 'Markland', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Camille P', 'Initials': 'CP', 'LastName': 'Vaughan', 'Affiliation': 'Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Atlanta, Georgia.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Redden', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Patricia S', 'Initials': 'PS', 'LastName': 'Goode', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.6398']
3321,32045316,Application of Nanocarbon in Breast Approach Endoscopic Thyroidectomy Thyroid Cancer Surgery.,"Objective: This study aimed to investigate the application of nanocarbon in surgical endoscopy in patients with thyroid cancer for the clinical tracing of level VI sentinel lymph nodes (SLNs) and for parathyroid gland protection. Materials and Methods: Ninety-three patients with papillary thyroid carcinoma (PTC) who underwent an endoscopic thyroid cancer operation were included. We randomly divided these patients into a control group ( n = 42) and a nanocarbon group ( n = 51). For the nanocarbon group, after thyroid exposure, nanocarbon was injected into the thyroid gland, and the SLNs were resected and subjected to frozen sectioning and routine pathological examination. In addition, the postoperative calcium and parathyroid hormone (PTH) levels of both groups were analyzed to compare the features of the nanocarbon application. Results: The number of central lymph (level VI) nodes dissected and the number of metastatic lymph nodes identified were analyzed in both groups. The number of dissected lymph nodes from both unilateral and bilateral thyroid surgeries was significantly larger in the nanocarbon group than in the control group. At the same time, the number of identified metastasis lymph nodes dissected were higher in the nanocarbon group than in the control group. We assessed the postoperative calcium and PTH level to evaluate the parathyroid function. Our results show that the nanocarbon group had a better protective effect on parathyroid function than the control group. Conclusions: As a lymph node trace agent, nanocarbon could better evaluate and permit a more clear lymph dissection for patients with PTC. Nanocarbon contributes to a decrease in the incidence rate of parathyroid damage, which has great clinical value.",2020,The number of dissected lymph nodes from both unilateral and bilateral thyroid surgeries was significantly larger in the nanocarbon group than in the control group.,"['patients with thyroid cancer for the clinical tracing of level VI sentinel lymph nodes (SLNs) and for parathyroid gland protection', 'Ninety-three patients with papillary thyroid carcinoma (PTC) who underwent an endoscopic thyroid cancer operation were included', 'Breast Approach Endoscopic Thyroidectomy Thyroid Cancer Surgery', 'patients with PTC']","['nanocarbon', 'Nanocarbon']","['number of identified metastasis lymph nodes', 'postoperative calcium and PTH level', 'parathyroid function', 'number of dissected lymph nodes', 'postoperative calcium and parathyroid hormone (PTH) levels', 'number of central lymph']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0030518', 'cui_str': 'Parathyroid structure (body structure)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0238463', 'cui_str': 'Thyroid Cancer, Papillary'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0015491', 'cui_str': 'factor IX'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030518', 'cui_str': 'Parathyroid structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205239', 'cui_str': 'Dissecting (qualifier value)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0024202', 'cui_str': 'Lymph'}]",93.0,0.0318611,The number of dissected lymph nodes from both unilateral and bilateral thyroid surgeries was significantly larger in the nanocarbon group than in the control group.,"[{'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Ma', 'Affiliation': 'Department of Surgery, Linhai Hospital of Traditional Chinese Medicine, Taizhou, P.R. China.'}, {'ForeName': 'Dong-Bao', 'Initials': 'DB', 'LastName': 'Zhang', 'Affiliation': 'Department of Surgery, Linhai Hospital of Traditional Chinese Medicine, Taizhou, P.R. China.'}, {'ForeName': 'Wei-Feng', 'Initials': 'WF', 'LastName': 'Zhang', 'Affiliation': 'Department of Surgery, Linhai Hospital of Traditional Chinese Medicine, Taizhou, P.R. China.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Surgery, Linhai Hospital of Traditional Chinese Medicine, Taizhou, P.R. China.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2019.0794']
3322,32043205,Communicating cardiovascular risk to high-risk cancer survivors: a mixed-methods pilot study of a statin risk communication tool.,"PURPOSE
Childhood, adolescent, and young adult cancer survivors treated with radiation therapy (RT) may be unaware of their high cardiovascular disease (CVD) risk or how to mitigate it. Tools are needed to improve understanding. We developed and pilot-tested a risk communication tool for shared decision-making with survivors regarding CVD risk reduction with statin therapy. We included quantitative and qualitative arms to further tool development and testing.
METHODS
The statin risk communication tool was adapted from a previously validated tool. Patients were at increased risk for CVD due to history of chest RT and recruited to usual care and intervention arms. The post-visit survey included Likert-like scales to explore acceptability of the tool, knowledge questions, and a decisional conflict scale. This pilot study used descriptive statistics and was not powered for significance. Semi-structured interviews with intervention arm participants explored shared decision-making processes.
RESULTS
Median participant (n = 46) age was 45. Most intervention patients (22/24, 92%) and 50% (11/22) of controls found statin information acceptable while 31% (7/22) of the control arm selected ""not applicable"" regarding information acceptability. Most participants were unaware of their personal CVD risk or potential statin side effects. In semi-structured interviews, participants found the tool is helpful to visualize risk and aid conversations.
CONCLUSIONS
The risk communication tool was acceptable. Qualitative data suggested the tool improved decisional clarity and comfort.
IMPLICATIONS FOR CANCER SURVIVORS
Poor knowledge of CVD and statins and poor recall of CVD risk conversation suggest a need to continue to optimize conversations regarding cardiovascular risk and statin therapy.",2020,"Most intervention patients (22/24, 92%) and 50% (11/22) of controls found statin information acceptable while 31% (7/22) of the control arm selected ""not applicable"" regarding information acceptability.","['young adult cancer survivors treated with', 'high-risk cancer survivors', '46) age was 45']","['radiation therapy (RT', 'statin therapy']","['personal CVD risk or potential statin side effects', 'decisional clarity and comfort', 'Likert-like scales to explore acceptability of the tool, knowledge questions, and a decisional conflict scale']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property) (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}]",,0.0297871,"Most intervention patients (22/24, 92%) and 50% (11/22) of controls found statin information acceptable while 31% (7/22) of the control arm selected ""not applicable"" regarding information acceptability.","[{'ForeName': 'Nirupa J', 'Initials': 'NJ', 'LastName': 'Raghunathan', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, 485 Lexington Ave, 2nd Floor, New York City, NY, 10017, USA. raghunan@mskcc.org.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Zabor', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Anderson', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, 485 Lexington Ave, 2nd Floor, New York City, NY, 10017, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Oeffinger', 'Affiliation': 'Duke Cancer Institute, Durham, NC, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Tonorezos', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, 485 Lexington Ave, 2nd Floor, New York City, NY, 10017, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Korenstein', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, 485 Lexington Ave, 2nd Floor, New York City, NY, 10017, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00860-4']
3323,32039987,Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial.,"MINI: In this randomized clinical trial to prevent anastomotic recurrence in Crohn disease, the new Kono-S anastomosis demonstrates a significant reduction in postoperative clinical and endoscopic recurrence rates after ileocolic surgery than conventional side-to-side anastomosis and no safety issues.
OBJECTIVE
This trial aimed to provide randomized controlled data comparing Kono-S anastomosis and stapled ileocolic side-to-side anastomosis.
BACKGROUND
Recently, a new antimesenteric, functional, end-to-end, hand-sewn ileocolic anastomosis (Kono-S) has shown a significant reduction in endoscopic recurrence score and surgical recurrence rate in Crohn disease (CD).
METHODS
Randomized controlled trial (RCT) at a tertiary referral institution. Primary endpoint: endoscopic recurrence (ER) (Rutgeerts score ≥i2) after 6 months. Secondary endpoints: clinical recurrence (CR) after 12 and 24 months, ER after 18 months, and surgical recurrence (SR) after 24 months.
RESULTS
In all, 79 ileocolic CD patients were randomized in Kono group (36) and Conventional group (43). After 6 months, 22.2% in the Kono group and 62.8% in the Conventional group presented an ER [P < 0.001, odds ratio (OR) 5.91]. A severe postoperative ER (Rutgeerts score ≥i3) was found in 13.8% of Kono versus 34.8% of Conventional group patients (P = 0.03, OR 3.32). CR rate was 8% in the Kono group versus 18% in the Conventional group after 12 months (P = 0.2), and 18% versus 30.2% after 24 months (P = 0.04, OR 3.47). SR rate after 24 months was 0% in the Kono group versus 4.6% in the Conventional group (P = 0.3). Patients with Kono-S anastomosis presented a longer time until CR than patients with side-to-side anastomosis (hazard ratio 0.36, P = 0.037). On binary logistic regression analysis, the Kono-S anastomosis was the only variable significantly associated with a reduced risk of ER (OR 0.19, P < 0.001). There were no differences in postoperative outcomes.
CONCLUSIONS
This is the first RCT comparing Kono-S anastomosis and standard anastomosis in CD. The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.ClinicalTrials.gov ID NCT02631967.",2020,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[""Crohn's Disease"", '79 ileocolic CD patients']","['Kono-S anastomosis and stapled ileocolic side-to-side anastomosis', 'MINI']","['SR rate', 'longer time until CR', 'postoperative outcomes', 'postoperative endoscopic and clinical recurrence rate', 'CR rate', 'endoscopic recurrence (ER) ', 'postoperative clinical and endoscopic recurrence rates', 'severe postoperative ER', 'endoscopic recurrence score and surgical recurrence rate', 'clinical recurrence (CR', 'reduced risk of ER', 'surgical recurrence (SR']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0677619', 'cui_str': 'Side-to-side anastomosis (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",79.0,0.165843,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Luglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rispo', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Imperatore', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Mariano Cesare', 'Initials': 'MC', 'LastName': 'Giglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Amendola', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Francesca Paola', 'Initials': 'FP', 'LastName': 'Tropeano', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Peltrini', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Castiglione', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Giovanni Domenico', 'Initials': 'GD', 'LastName': 'De Palma', 'Affiliation': 'Surgical Endoscopy, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bucci', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}]",Annals of surgery,['10.1097/SLA.0000000000003821']
3324,31930369,Extended Follow-up From a Randomized Clinical Trial of Routine Amoxicillin in the Treatment of Uncomplicated Severe Acute Malnutrition in Niger.,,2020,,['Uncomplicated Severe Acute Malnutrition in Niger'],['Routine Amoxicillin'],[],"[{'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}]",[],,0.0562534,,"[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Isanaka', 'Affiliation': 'Department of Research, Epicentre, Paris, France.'}, {'ForeName': 'Kyra H', 'Initials': 'KH', 'LastName': 'Grantz', 'Affiliation': 'Department of Research, Epicentre, Paris, France.'}, {'ForeName': 'Fatou', 'Initials': 'F', 'LastName': 'Berthé', 'Affiliation': 'Epicentre, Niamey, Niger.'}, {'ForeName': 'Myrto', 'Initials': 'M', 'LastName': 'Schaefer', 'Affiliation': 'Médecins Sans Frontières Operational Center Paris, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Adehossi', 'Affiliation': 'National Hospital, Niamey, Niger.'}, {'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Grais', 'Affiliation': 'Department of Research, Epicentre, Paris, France.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.5189']
3325,32044871,FORGOT CALCIUM? ADMISSION IONIZED-CALCIUM IN TWO CIVILIAN RANDOMIZED CONTROLLED TRIALS OF PRE-HOSPITAL PLASMA FOR TRAUMATIC HEMORRHAGIC SHOCK.,"BACKGROUND
Randomized clinical trials(RCTs) support the use of pre-hospital plasma in traumatic hemorrhagic shock, especially in long transports. The citrate added to plasma binds with calcium, yet most pre-hospital trauma protocols have no guidelines for calcium replacement. We reviewed the experience of two recent pre-hospital plasma RCTs regarding admission ionized-calcium (i-Ca) blood levels and its impact on survival. We hypothesized that pre-hospital plasma is associated with hypocalcemia, which in turn is associated with lower survival.
METHODS
We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation. Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm) were eligible. We use generalized linear mixed models with random intercepts and Cox proportional hazards models with robust standard errors to account for clustered data by institution. Hypocalcemia was defined as i-Ca<1.0mmol/L.
RESULTS
Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34). Pre-hospital plasma and control patients were similar regarding age, sex, ISS, blunt mechanism, and brain injury. Pre-hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03). Severe hypocalcemia was significantly associated with decreased survival(Adjusted Hazard Ratio:1.07;95%CI:1.02-1.13, p=0.01) and massive transfusion(aRR= 2.70;95%CI:1.13-6.46, p=0.03), after adjustment for confounders(randomization group, age, ISS, and shock index).
CONCLUSION
Pre-hospital plasma in civilian trauma is associated with hypocalcemia, which in turn predicts lower survival and massive transfusion. These data underscore the need for explicit calcium supplementation guidelines in pre-hospital hemotherapy.
LEVEL OF EVIDENCE
",2020,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","['Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm', 'Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34', 'We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation']",[],"['massive transfusion(aRR', 'Hypocalcemia', 'Severe hypocalcemia', 'rates of hypocalcemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043253', 'cui_str': 'Injuries, Nonpenetrating'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}]",[],"[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.275164,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","[{'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': 'Combat Casualty Care Research Program, US Army Medical Research Materiel Command, Fort Detrick, Maryland.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': 'University of Colorado.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002614']
3326,32033773,Incoming residents' knot-tying and suturing skills: Are medical school boot camps sufficient?,"INTRODUCTION
Many medical schools offer M4 boot camps to improve students' preparedness for surgical residencies. For three consecutive years, we investigated the impact of medical school boot camps on intern knot-tying and suturing skills when measured at the start of residency.
METHODS
Forty-two interns completed questionnaires regarding their boot camp experiences. Their performance on knot-tying and suturing exercises was scored by three surgeons blinded to the questionnaire results. A comparison of these scores of interns with or without boot camp experiences was performed and statistical analysis applied.
RESULTS
26 of 42 (62%) interns reported boot camp training. There were no differences in scores between interns with or without a M4 boot camp experience for suturing [9.6(4.6) vs 9.8(4.1), p < 0.908], knot-tying [9.1(3.6) vs 8.4(4.1), p = 0.574], overall performance [2.0(0.6) vs 1.9(0.7), p = 0.424], and quality [2.0(0.6) vs 1.9(0.7), p = 0.665]) (mean(SD)).
CONCLUSIONS
We could not demonstrate a statistically significant benefit in knot-tying and suturing skills of students who enrolled in M4 boot camp courses as measured at the start of surgical residency.",2020,We could not demonstrate a statistically significant benefit in knot-tying and suturing skills of students who enrolled in M4 boot camp courses as measured at the start of surgical residency.,['Forty-two interns completed questionnaires regarding their boot camp experiences'],"['knot-tying and suturing skills', 'knot-tying and suturing exercises']",['knot-tying and suturing skills'],"[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}]","[{'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}]",,0.0182404,We could not demonstrate a statistically significant benefit in knot-tying and suturing skills of students who enrolled in M4 boot camp courses as measured at the start of surgical residency.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McMillan', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Redlich', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA; Division of Surgical Care, Clement J. Zablocki VA Medical Center, 5000 W National Ave, Milwaukee, WI, 53295, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Treat', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Matthew I', 'Initials': 'MI', 'LastName': 'Goldblatt', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Carver', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Dodgion', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Jacob R', 'Initials': 'JR', 'LastName': 'Peschman', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Davis', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Shahriar', 'Initials': 'S', 'LastName': 'Alizadegan', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Grushka', 'Affiliation': 'Montreal General Hospital, 1650 Cedar Avenue,L9.424, Montreal, QC, H3G 1A4, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Olson', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Krausert', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lewis', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA; Division of Surgical Care, Clement J. Zablocki VA Medical Center, 5000 W National Ave, Milwaukee, WI, 53295, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Malinowski', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA; Division of Surgical Care, Clement J. Zablocki VA Medical Center, 5000 W National Ave, Milwaukee, WI, 53295, USA. Electronic address: mmalinowski@mcw.edu.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.01.031']
3327,31564317,Cystoid macular edema with prostaglandin analogue use after uneventful cataract surgery in glaucoma patients.,"PURPOSE
To evaluate the effect of postoperative latanoprost administration on central macular thickness (CMT) after uneventful cataract surgery in glaucoma patients.
SETTING
Farabi Eye Hospital, Tehran, Iran.
DESIGN
Prospective randomized clinical trial.
METHODS
In this single-masked trial, glaucoma patients treated with latanoprost who had no other risk factor for the development of pseudophakic macular edema were randomly allocated to continuation of latanoprost or discontinuation of the drop after uneventful cataract surgery. At baseline and postoperatively at 1 month and 3 months, patients had complete ocular examinations and CMT measurements using optical coherence tomography. The main outcome measure was the change in the CMT between baseline measurements and postoperative measurements at 1 month and 3 months.
RESULTS
One hundred fifty-six eyes (latanoprost 76; discontinuation 80) finished the trial. There were no differences in baseline patient demographics or characteristics, including the CMT, between the two groups. There was transient increase in the mean CMT by 12 μm ± 49 (SD) in the latanoprost group at 1 month (P = .03); however, the value returned to baseline by 3 months (6 ± 55 μm; P = .27). The between-group difference in the mean change in the CMT from baseline was -3.1 μm (95% confidence interval [CI], -18.4 to 12.0; P = .68) after 1 month and -10.5 μm (95% CI, -26.6 to 5.5; P = .19) after 3 months; the differences were not significant.
CONCLUSION
Latanoprost administration after cataract surgery had no measurable effect on macular thickness.",2019,The between-group difference in the mean change in the CMT from baseline was -3.1 μm,"['Farabi Eye Hospital, Tehran, Iran', 'glaucoma patients treated with latanoprost who had no other risk factor for the development of pseudophakic macular edema', 'One hundred fifty-six eyes (latanoprost 76; discontinuation 80) finished the trial', 'central macular thickness (CMT) after uneventful cataract surgery in glaucoma patients', 'glaucoma patients']","['Latanoprost', 'latanoprost', 'postoperative latanoprost', 'prostaglandin analogue']","['change in the CMT between baseline measurements and postoperative measurements', 'Cystoid macular edema', 'mean CMT', 'macular thickness']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0090306', 'cui_str': 'latanoprost acid'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C0090306', 'cui_str': 'latanoprost acid'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0033568', 'cui_str': 'Prostaglandin Analogs'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0024440', 'cui_str': 'Macular Dystrophy, Dominant Cystoid'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",156.0,0.190825,The between-group difference in the mean change in the CMT from baseline was -3.1 μm,"[{'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Fakhraie', 'Affiliation': 'Farabi Eye Hospital, Tehran University of Medical Sciences, Iran; William and Anna Goldberg Glaucoma Service and Wills Eye Institute, Jefferson Medical College, Philadelphia, Pennsylvania, USA. Electronic address: gfakhraie@gmail.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Mirghorbani', 'Affiliation': 'Farabi Eye Hospital, Tehran University of Medical Sciences, Iran.'}, {'ForeName': 'L Jay', 'Initials': 'LJ', 'LastName': 'Katz', 'Affiliation': 'William and Anna Goldberg Glaucoma Service and Wills Eye Institute, Jefferson Medical College, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Mollazadeh', 'Affiliation': 'Farabi Eye Hospital, Tehran University of Medical Sciences, Iran.'}, {'ForeName': 'Zakieh', 'Initials': 'Z', 'LastName': 'Vahedian', 'Affiliation': 'Farabi Eye Hospital, Tehran University of Medical Sciences, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Zarei', 'Affiliation': 'Farabi Eye Hospital, Tehran University of Medical Sciences, Iran.'}, {'ForeName': 'Yadollah', 'Initials': 'Y', 'LastName': 'Eslami', 'Affiliation': 'Farabi Eye Hospital, Tehran University of Medical Sciences, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Farabi Eye Hospital, Tehran University of Medical Sciences, Iran.'}, {'ForeName': 'Nikoo', 'Initials': 'N', 'LastName': 'Hamzeh', 'Affiliation': 'Farabi Eye Hospital, Tehran University of Medical Sciences, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Masoomi', 'Affiliation': 'Farabi Eye Hospital, Tehran University of Medical Sciences, Iran.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2019.05.026']
3328,32029304,"Delgocitinib ointment, a topical Janus kinase inhibitor, in adult patients with moderate to severe atopic dermatitis: A phase 3, randomized, double-blind, vehicle-controlled study and an open-label, long-term extension study.","BACKGROUND
Previous studies showed the potential effectiveness of delgocitinib ointment, a novel topical Janus kinase inhibitor, in atopic dermatitis (AD).
OBJECTIVE
This study aimed to evaluate the efficacy and safety of delgocitinib 0.5% ointment.
METHODS
In part 1, a 4-week double-blind period, Japanese patients aged 16 years or older with moderate or severe AD were randomly assigned in a 2:1 ratio to delgocitinib 0.5% ointment or vehicle ointment. Eligible patients entered part 2, a 24-week extension period, to receive delgocitinib 0.5% ointment.
RESULTS
At the end of treatment in part 1, the least-squares mean percent changes from baseline in the modified Eczema Area and Severity Index score, the primary efficacy endpoint, were significantly greater in the delgocitinib group than in the vehicle group (-44.3% vs 1.7%, P < .001). The improvement in modified Eczema Area and Severity Index score was maintained in part 2. Most adverse events were mild and unrelated to delgocitinib across the study periods.
LIMITATIONS
Only Japanese patients were included. The vehicle-controlled period lasted only 4 weeks. In part 2, topical corticosteroids were allowed for the treatment of worsening of AD.
CONCLUSION
Delgocitinib ointment was effective and well tolerated in Japanese adult patients with moderate to severe AD for up to 28 weeks.",2020,Delgocitinib ointment was effective and well tolerated in Japanese adult patients with moderate to severe AD for up to 28 weeks.,"['Only Japanese patients', 'Japanese adult patients with moderate to severe AD for up to 28\xa0weeks', 'adult patients with moderate to severe atopic dermatitis', 'Japanese patients aged 16\xa0years or older with moderate or severe AD', 'atopic dermatitis (AD']","['topical Janus kinase inhibitor', 'topical corticosteroids', 'delgocitinib 0.5% ointment', 'delgocitinib ointment', 'delgocitinib 0.5% ointment or vehicle ointment', 'Delgocitinib ointment']","['modified Eczema Area and Severity Index score', 'effective and well tolerated', 'efficacy and safety']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C4521962', 'cui_str': 'Janus kinase inhibitor'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}]","[{'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.155106,Delgocitinib ointment was effective and well tolerated in Japanese adult patients with moderate to severe AD for up to 28 weeks.,"[{'ForeName': 'Hidemi', 'Initials': 'H', 'LastName': 'Nakagawa', 'Affiliation': 'Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Nemoto', 'Affiliation': 'Kojinkai Sapporo Skin Clinic, Hokkaido, Japan.'}, {'ForeName': 'Atsuyuki', 'Initials': 'A', 'LastName': 'Igarashi', 'Affiliation': 'Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hidehisa', 'Initials': 'H', 'LastName': 'Saeki', 'Affiliation': 'Department of Dermatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Kaino', 'Affiliation': 'Pharmaceutical Division, Japan Tobacco Inc, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nagata', 'Affiliation': 'Pharmaceutical Division, Japan Tobacco Inc, Tokyo, Japan. Electronic address: takeshi.nagata@jt.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.12.015']
3329,32040376,Immunogenicity persistence in children of hepatitis A vaccines Healive® and Havrix®: 11 years follow-up and long-term prediction.,"Background : Hepatitis A vaccine has been used in mass and routine public vaccination programs in China. Long-term follow-up studies are required to determine the duration of protection and the need for booster vaccinations. Methods : A prospective, randomized, open-label clinical trial was performed to compare the geometric mean concentration (GMC) and seroprotection rates of anti-Hepatitis A virus (HAV) antibodies elicited by the inactivated vaccines Healive and Havrix. 400 healthy children were randomly assigned 3:1 ratio to receive two doses of Healive or Havrix at 0 and 6 months. Persistence of anti-HAV antibodies for 5 years post immunization has been reported The current study reports new data at 11 years post immunization for the purpose of showing antibody persistence. Sensitivity analyzes were performed to assess the results. In addition, predictions for long-term antibody persistence were performed using a statistical model. Two different serological assays were used that were shown to be 98.3% concordant for detecting anit-HAV antibody. Results : GMCs were significantly higher following Healive compared to Havrix at 1, 6, 7, 66, 112 and 138 months post-vaccination. In addition, the GMCs obtained using sensitivity analysis were very similar to those obtained using the original models. Prediction analysis indicated that the duration of protection for both vaccines was at least 30 years after immunization, with a lower limit of the 95% confidence interval for GMC of greater than 20mIU/mL. Conclusions : Healive is more immunogenic than Havrix in children at 11 years post full immunization. Prediction analysis indicated at least 30 years of antibody persistence for both vaccines.",2020,"Results : GMCs were significantly higher following Healive compared to Havrix at 1, 6, 7, 66, 112 and 138 months post-vaccination.","['400 healthy children', 'children of hepatitis A vaccines Healive® and Havrix®', '5\xa0years']","['Healive or Havrix', ' ']","['geometric mean concentration (GMC) and seroprotection rates of anti-Hepatitis A virus (HAV) antibodies', 'Immunogenicity persistence']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0170300', 'cui_str': 'Hepatovirus Vaccines'}, {'cui': 'C0700881', 'cui_str': 'Havrix'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0700881', 'cui_str': 'Havrix'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0062524', 'cui_str': 'Anti-HAV'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}]",400.0,0.0335819,"Results : GMCs were significantly higher following Healive compared to Havrix at 1, 6, 7, 66, 112 and 138 months post-vaccination.","[{'ForeName': 'Yongji', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Health Statistics, School of Preventive Medicine, Air Force Military Medical University , Xi'an, Shaanxi, China.""}, {'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Qi', 'Affiliation': 'Department of Statistics, Beijing Key Tech Statistical Consulting Co., Ltd , Beijing, China.'}, {'ForeName': 'Wenguo', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Immunization Planning, Center for Disease Control and Prevention of Changzhou City , Changzhou, Jiangsu, China.'}, {'ForeName': 'Yuansheng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Clinical Research, Sinovac Biotech , Beijing, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Health Statistics, School of Preventive Medicine, Air Force Military Medical University , Xi'an, Shaanxi, China.""}, {'ForeName': 'Yongpei', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Statistics, Peking University Clinical Research Institute, Peking University Health Science Center , Beijing, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Statistics, Beijing Key Tech Statistical Consulting Co., Ltd , Beijing, China.'}, {'ForeName': 'Jielai', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ""Department of Health Statistics, School of Preventive Medicine, Air Force Military Medical University , Xi'an, Shaanxi, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Department of Clinical Research, Sinovac Biotech , Beijing, China.'}, {'ForeName': 'Yalong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Immunization Planning, Center for Disease Control and Prevention of Changzhou City , Changzhou, Jiangsu, China.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1715687']
3330,32029375,Eye Shielding During Head CT Scans: Dose Reduction and Image Quality Evaluation.,"RATIONALE AND OBJECTIVES
In this study, we assessed the radiation dose to the lens and the impacts of various eye shields using either a fixed or modulated tube current.
MATERIALS AND METHODS
Patients undergoing head computed tomography (CT) examinations were recruited, and each was randomly assigned to one of five imaging groups, either without a CT eye shield or with one of two types of shielding and topogram-based tube current modulation (TCM). The radiation dose at the eye lens was estimated using Gafchromic films. All CT images were analyzed for quality in the orbit and brain areas. Two radiologists also qualitatively assessed image artifacts and their impacts on image quality using three-point Likert scales.
RESULTS
Both barium sulfate and bismuth-antimony shields significantly reduced radiation dose to the lens (by 28.60%-31.92% and 43.87%-47.00%, respectively) while significantly inducing image artifacts. The image quality of the intraocular structure, but not the intracranial structure, was significantly degraded by shielding. In addition, discriminating the periocular tissues was improved using a bismuth-antimony shield and topogram-based TCM. Compared to fixed tube current, topogram-based TCM provided better signal-to-noise and contrast-to-noise ratios in the intracranial structures when the bismuth-antimony and barium sulfate shields were applied, respectively.
CONCLUSION
Artifacts resulting from the application of eye shields during head CT examinations can be reduced by using topogram-based TCM instead of a fixed tube current. This could be an alternative approach for maintaining image quality in CT scans that do not encompass organ-based TCM.",2020,"The image quality of the intraocular structure, but not the intracranial structure, was significantly degraded by shielding.",['Patients undergoing head computed tomography (CT) examinations'],"['CT eye shield or with one of two types of shielding and topogram-based tube current modulation (TCM', 'barium sulfate and bismuth-antimony', 'bismuth-antimony shield and topogram-based TCM', 'fixed tube current, topogram-based TCM']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0183251', 'cui_str': 'Shield, device (physical object)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0412670', 'cui_str': 'Digital slit-beam radiograph (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0004754', 'cui_str': 'Barium Sulfate'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0202321', 'cui_str': 'Antimony measurement (procedure)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}]",[],,0.0241579,"The image quality of the intraocular structure, but not the intracranial structure, was significantly degraded by shielding.","[{'ForeName': 'Yuan-Hao', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Wan Fang Hospital, Taipei Medical University, 111 Hsing-Long Road, Section 3, Taipei, Taiwan.'}, {'ForeName': 'Shih-Hung', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, Wan Fang Hospital, Taipei Medical University, 111 Hsing-Long Road, Section 3, Taipei, Taiwan; Department of Radiology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yen-Kuang', 'Initials': 'YK', 'LastName': 'Lin', 'Affiliation': 'Biostatistics Center, Taipei Medical University, Taipei, Taiwan; Graduate Institute of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Randolph D', 'Initials': 'RD', 'LastName': 'Glickman', 'Affiliation': 'Department of Ophthalmology, University of Texas Health Science Center, San Antonio, Texas.'}, {'ForeName': 'Chia-Yuen', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Wan Fang Hospital, Taipei Medical University, 111 Hsing-Long Road, Section 3, Taipei, Taiwan; Department of Radiology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Wing P', 'Initials': 'WP', 'LastName': 'Chan', 'Affiliation': 'Department of Radiology, Wan Fang Hospital, Taipei Medical University, 111 Hsing-Long Road, Section 3, Taipei, Taiwan; Department of Radiology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: wingchan@tmu.edu.tw.'}]",Academic radiology,['10.1016/j.acra.2019.12.011']
3331,31562765,"The Put It Out Project (POP) Facebook Intervention for Young Sexual and Gender Minority Smokers: Outcomes of a Pilot, Randomized, Controlled Trial.","INTRODUCTION
This trial investigated whether a Facebook smoking cessation intervention culturally tailored to young sexual and gender minority (SGM) smokers (versus non-tailored) would increase smoking abstinence.
METHODS
Participants were 165 SGM young adult US smokers (age 18-25) recruited from Facebook in April 2018 and randomized to an SGM-tailored (POP; N = 84) or non-tailored (TSP-SGM; N = 81) intervention. Interventions delivered weekly live counseling sessions and 90 daily Facebook posts to participants in Facebook groups. Primary analyses compared POP and TSP-SGM on biochemically verified smoking abstinence (yes/no; primary outcome), self-reported 7-day point prevalence abstinence (yes/no), reduction in cigarettes per week by 50+% from baseline (yes/no), making a quit attempt during treatment (yes/no), and stage of change (precontemplation/contemplation vs. preparation/action). Supplemental analyses compared POP to two historical control groups.
RESULTS
POP participants were more likely than TSP-SGM participants to report smoking abstinence at 3 (23.8% vs. 12.3%; OR = 2.50; p = .03) and 6 months (34.5% vs. 12.3%; OR = 4.06; p < .001) and reduction in smoking at 3 months (52.4% vs. 39.5%; OR = 2.11; p = .03). Biochemically verified smoking abstinence did not significantly differ between POP and TSP-SGM at 3 (OR = 2.00; p = .33) or 6 months (OR = 3.12; p = .08), potentially due to challenges with remote biochemical verification. In supplemental analyses, POP participants were more likely to report abstinence at 3 (OR = 6.82, p = .01) and 6 (OR = 2.75, p = .03) months and reduced smoking at 3 months (OR = 2.72, p = .01) than participants who received a referral to Smokefree.gov.
CONCLUSIONS
This pilot study provides preliminary support for the effectiveness of a Facebook smoking cessation intervention tailored to SGM young adults.
IMPLICATIONS
SGM individuals have disproportionately high smoking prevalence. It is unclear whether smoking cessation interventions culturally tailored to the SGM community are more effective than non-tailored interventions. This pilot trial found preliminary evidence that an SGM-tailored Facebook smoking cessation intervention increased reported abstinence from smoking, compared to a non-tailored intervention.
TRIAL REGISTRATION
NCT03259360.",2020,"This pilot trial found preliminary evidence that an SGM-tailored Facebook smoking cessation intervention increased reported abstinence from smoking, compared to a non-tailored intervention.","['SGM young adults', 'Participants were 165 SGM young adult U.S. smokers (age 18-25) recruited from Facebook in April 2018 and randomized to an', 'Young Sexual and Gender Minority Smokers', 'Sexual and gender minority (SGM) individuals have disproportionately high smoking prevalence', 'young sexual and gender minority (SGM) smokers (versus non-tailored']","['live counseling sessions', 'Facebook smoking cessation intervention', 'SGM-tailored (POP; N=84) or non-tailored (TSP-SGM; N=81) intervention', 'SGM-tailored Facebook smoking cessation intervention', 'Facebook Intervention']","['self-reported 7-day point prevalence abstinence', 'POP and TSP-SGM on biochemically verified smoking abstinence', 'report abstinence', 'smoking abstinence']","[{'cui': 'C4521841', 'cui_str': 'MGySgt'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C1533179', 'cui_str': 'Tsp'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C1533179', 'cui_str': 'Tsp'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.0275547,"This pilot trial found preliminary evidence that an SGM-tailored Facebook smoking cessation intervention increased reported abstinence from smoking, compared to a non-tailored intervention.","[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Vogel', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Ramo', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Meredith C', 'Initials': 'MC', 'LastName': 'Meacham', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Humfleet', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz184']
3332,31564314,Blue light-filtering and violet light-filtering hydrophobic acrylic foldable intraocular lenses: Intraindividual comparison.,"PURPOSE
To compare the clinical outcomes after cataract surgery and implantation of a blue light-filtering IOL (AcrySof IQ SN60WF) or a violet light-filtering intraocular lens (IOL) (OptiBlue ZCB00V).
SETTING
Four surgical sites in Japan.
DESIGN
Prospective case series.
METHODS
One eye of patients with bilateral cataract was randomly allocated to the blue light-filtering IOL and the fellow eye to the violet light-filtering IOL. Visual acuity and contrast sensitivity were assessed over 3 months. The incidence of cyanopsia was evaluated using the neutralization method.
RESULTS
The study enrolled 110 eyes of 55 patients. There was no significant difference in visual acuity between the two IOLs. Based on the neutralization results 1 week postoperatively, 15 cases (27.8%) with the light-filtering IOL and 8 cases (14.8%) with the violent light-filtering IOL had cyanopsia; the difference reached statistical significance (P = .049). After 2 weeks, the difference in the incidence of cyanopsia was not significant. Postoperative contrast sensitivity under photopic condition at 1 week and 3 months and contrast sensitivity under mesopic conditions at 3 months were significantly better with the violet light-filtering IOL than with the blue light-filtering IOL (P < .05).
CONCLUSIONS
The violet light-filtering IOL yielded highly satisfactory clinical outcomes, including reduction of cyanopsia and a potential improvement in contrast sensitivity. The different chromophores of the IOL and its different material and design might have contributed.",2019,There was no significant difference in visual acuity between the two IOLs.,"['The study enrolled 110 eyes of 55 patients', 'Four surgical sites in Japan', 'One eye of patients with bilateral cataract']","['violet light-filtering intraocular lens (IOL) (OptiBlue ZCB00V', 'cataract surgery and implantation of a blue light-filtering IOL (AcrySof IQ SN60WF', 'blue light-filtering IOL and the fellow eye to the violet light-filtering IOL', 'Blue light-filtering and violet light-filtering hydrophobic acrylic foldable intraocular lenses']","['incidence of cyanopsia', 'Postoperative contrast sensitivity under photopic condition', 'visual acuity', 'Visual acuity and contrast sensitivity']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts (disorder)'}]","[{'cui': 'C0330463', 'cui_str': 'Violet'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0303896', 'cui_str': 'Blue light (physical force)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material (substance)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0854725', 'cui_str': 'Cyanopsia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",110.0,0.0109909,There was no significant difference in visual acuity between the two IOLs.,"[{'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Division of Ophthalmology, Ryugasaki Saiseikai Hospital, Ibaraki, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Miyata', 'Affiliation': 'Miyata Eye Clinic, Hiroshima, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Kizawa', 'Affiliation': 'Department of Ophthalmology, Iwate Medical University, Japan.'}, {'ForeName': 'Daijiro', 'Initials': 'D', 'LastName': 'Kurosaka', 'Affiliation': 'Department of Ophthalmology, Iwate Medical University, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Miyata', 'Affiliation': 'Miyata Eye Hospital, Miyazaki, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Oshika', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan. Electronic address: oshika@eye.ac.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2019.05.027']
3333,32026173,A Randomized Controlled Trial of an Intelligent Robotic Response to Joint Attention Intervention System.,"Although there has been growing interest in utilizing robots for intervention in autism spectrum disorder (ASD), there have been very few controlled trials to assess the actual impacts of such systems on social communication vulnerabilities. This study reports a randomized controlled trial to investigate a robot-mediated response to joint attention intervention in a small (23 recruited; 20 completed) group of young children (average age = 2.54 years) with ASD. Small and nonsignificant group differences were observed regarding improvements in response to joint attention skills within and beyond the intervention. The sample showed tremendous individual variability in response to the system. Results highlight the current challenges related to developing pragmatic, beneficial, and generalizable robotic intervention systems for the targeted population.",2020,Small and nonsignificant group differences were observed regarding improvements in response to joint attention skills within and beyond the intervention.,"['a small (23 recruited; 20 completed) group of young children (average age\u2009=\u20092.54\xa0years) with ASD', 'autism spectrum disorder (ASD']",['robot-mediated response to joint attention intervention'],['response to joint attention skills'],"[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0678958,Small and nonsignificant group differences were observed regarding improvements in response to joint attention skills within and beyond the intervention.,"[{'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Department of Biomedical Engineering, Rochester Institute of Technology, 160 Lomb Memorial Drive, Building 73, Rochester, NY, 14623, USA. zhzbme@rit.edu.'}, {'ForeName': 'Guangtao', 'Initials': 'G', 'LastName': 'Nie', 'Affiliation': 'Department of Electrical Engineering and Computer Science, Vanderbilt University, Olin Hall Room 101, 2400 Highland Avenue, Nashville, TN, 37212, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Swanson', 'Affiliation': 'Treatment and Research Institute of Autism Spectrum Disorders, Vanderbilt Kennedy Center, Vanderbilt University Medical Center, 110 Magnolia Circle, Nashville, TN, 37203, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Weitlauf', 'Affiliation': 'Treatment and Research Institute of Autism Spectrum Disorders, Vanderbilt Kennedy Center, Vanderbilt University Medical Center, 110 Magnolia Circle, Nashville, TN, 37203, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Warren', 'Affiliation': 'Treatment and Research Institute of Autism Spectrum Disorders, Vanderbilt Kennedy Center, Vanderbilt University Medical Center, 110 Magnolia Circle, Nashville, TN, 37203, USA.'}, {'ForeName': 'Nilanjan', 'Initials': 'N', 'LastName': 'Sarkar', 'Affiliation': 'Department of Electrical Engineering and Computer Science, Vanderbilt University, Olin Hall Room 101, 2400 Highland Avenue, Nashville, TN, 37212, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04388-5']
3334,32038017,"Preoperative fasting - ""nihil per os"" a difficult myth to break down: a randomized controlled study.","INTRODUCTION
For several years the scientific anaesthesia societies declared a preoperative fast of 6 hours for solid foods and 2 hours for clear liquids before elective surgical interventions to be sufficient. The aim of this study is to identify the extent of the gap that exists between the preoperative fasting time required and that actually encountered in operating rooms.
PATIENTS AND METHODS
The safety and clinical applicability of a reduction of the preoperative fasting time was investigated through the use of oral solutions enriched with maltodextrin and their effects on the pre- and postoperative well-being that this may have on patients who are candidates for elective abdominal surgery. The study was conducted in two successive phases (I and II) and patients divided into two groups (A and B).
DISCUSSION
Clinical practice is slow to change, in fact, in our study the duration of fasting was an average of 19 hours for solids and 13 hours for liquids. The duration of the fasting did not show differences in the various surgical departments, demonstrating that it is a transversal practice and is not only limited to abdominal surgery in which the utility of fasting would theoretically be greater. Among Group patients A, the fasting time for liquids was about 9 hours. This shows that the time is certainly shorter but not much different when compared to the fasting time for liquids in group B which was on average 14 hours. It is important how difficult it is to achieve good compliance from patients when trying to reduce the time of preoperative fasting based on scientific evidence that is now well established.
CONCLUSION
The use of carbohydrate-enriched drinks up to 2 hours after induction of anaesthesia appears to be a safe procedure. The use of these solutions reduces the catabolic response to surgery and contributes to maintaining a pre-operative state of well-being by reducing feelings of hunger and thirst and the state of preoperative anxiety.",2020,This shows that the time is certainly shorter but not much different when compared to the fasting time for liquids in group B which was on average 14 hours.,['patients who are candidates for elective abdominal surgery'],"['carbohydrate-enriched drinks', 'Preoperative fasting - ""nihil per os', 'maltodextrin']","['catabolic response', 'fasting time for liquids']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1527415', 'cui_str': 'Per oral route'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}]",,0.0161361,This shows that the time is certainly shorter but not much different when compared to the fasting time for liquids in group B which was on average 14 hours.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Panebianco', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Laforgia', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Volpi', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Punzo', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Vacca', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Minafra', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Di Salvo', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pezzolla', 'Affiliation': ''}]",Il Giornale di chirurgia,[]
3335,31873788,A single bout of resistance exercise improves postprandial lipid metabolism in overweight/obese men with prediabetes.,"AIMS/HYPOTHESIS
Prediabetes is associated with postprandial hypertriacylglycerolaemia. Resistance exercise acutely lowers postprandial plasma triacylglycerol (TG); however, the changes in lipid metabolism that mediate this reduction are poorly understood. The aim of this study was to identify the constitutive metabolic mechanisms underlying the changes in postprandial lipid metabolism after resistance exercise in obese men with prediabetes.
METHODS
We evaluated the effect of a single bout of whole-body resistance exercise (seven exercises, three sets, 10-12 repetitions at 80% of one-repetition maximum) on postprandial lipid metabolism in ten middle-aged (50 ± 9 years), overweight/obese (BMI: 33 ± 3 kg/m 2 ), sedentary men with prediabetes (HbA 1c >38 but <48 mmol/mol [>5.7% but <6.5%]), or fasting plasma glucose >5.6 mmol/l but <7.0 mmol/l or 2 h OGTT glucose >7.8 mmol/l but <11.1 mmol/l). We used a randomised, crossover design with a triple-tracer mixed meal test (ingested [( 13 C 4 ) 3 ]tripalmitin, i.v. [U- 13 C 16 ]palmitate and [ 2 H 5 ]glycerol) to evaluate chylomicron-TG and total triacylglycerol-rich lipoprotein (TRL)-TG kinetics. We used adipose tissue and skeletal muscle biopsies to evaluate the expression of genes regulating lipolysis and lipid oxidation, skeletal muscle respirometry to evaluate oxidative capacity, and indirect calorimetry to assess whole-body lipid oxidation.
RESULTS
The single bout of resistance exercise reduced the lipaemic response to a mixed meal in obese men with prediabetes without changing chylomicron-TG or TRL-TG fractional clearance rates. However, resistance exercise reduced endogenous and meal-derived fatty acid incorporation into chylomicron-TG and TRL-TG. Resistance exercise also increased whole-body lipid oxidation, skeletal muscle mitochondrial respiration, oxidative gene expression in skeletal muscle, and the expression of key lipolysis genes in adipose tissue.
CONCLUSIONS/INTERPRETATION
A single bout of resistance exercise improves postprandial lipid metabolism in obese men with prediabetes, which may mitigate the risk for cardiovascular disease and type 2 diabetes.",2020,"Resistance exercise also increased whole-body lipid oxidation, skeletal muscle mitochondrial respiration, oxidative gene expression in skeletal muscle, and the expression of key lipolysis genes in adipose tissue.
","['ten middle-aged (50\u2009±\u20099\xa0years), overweight/obese (BMI: 33\u2009±\u20093\xa0kg/m 2 ), sedentary men with prediabetes (HbA 1c >38 but <48\xa0mmol/mol [>5.7% but <6.5%]), or fasting plasma glucose >5.6\xa0mmol/l but <7.0\xa0mmol/l or 2', 'obese men with prediabetes', 'overweight/obese men with prediabetes', 'obese men with prediabetes without changing chylomicron-TG or TRL-TG fractional clearance rates']","['resistance exercise', 'U- 13 C 16 ]palmitate and [ 2 H 5 ]glycerol', 'Resistance exercise', 'single bout of whole-body resistance exercise (seven exercises, three sets, 10-12 repetitions at 80% of one-repetition maximum']","['chylomicron-TG and total triacylglycerol-rich lipoprotein (TRL)-TG kinetics', 'postprandial plasma triacylglycerol (TG', 'lipaemic response', 'postprandial lipid metabolism']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0008731', 'cui_str': 'Chylomicrons'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0729631', 'cui_str': 'C-13 isotope'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0008731', 'cui_str': 'Chylomicrons'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",,0.0657195,"Resistance exercise also increased whole-body lipid oxidation, skeletal muscle mitochondrial respiration, oxidative gene expression in skeletal muscle, and the expression of key lipolysis genes in adipose tissue.
","[{'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Bittel', 'Affiliation': 'Program in Physical Therapy, Washington University, St Louis, Campus Box 8502, 4444 Forest Park Ave., St Louis, MO, 63110, USA. bittela@wusm.wustl.edu.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Bittel', 'Affiliation': 'Program in Physical Therapy, Washington University, St Louis, Campus Box 8502, 4444 Forest Park Ave., St Louis, MO, 63110, USA.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Mittendorfer', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Adewole L', 'Initials': 'AL', 'LastName': 'Okunade', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yoshino', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Lane C', 'Initials': 'LC', 'LastName': 'Porter', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Nada A', 'Initials': 'NA', 'LastName': 'Abumrad', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Dominic N', 'Initials': 'DN', 'LastName': 'Reeds', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'W Todd', 'Initials': 'WT', 'LastName': 'Cade', 'Affiliation': 'Program in Physical Therapy, Washington University, St Louis, Campus Box 8502, 4444 Forest Park Ave., St Louis, MO, 63110, USA.'}]",Diabetologia,['10.1007/s00125-019-05070-x']
3336,32037483,Can We Play Together? A Closer Look at the Peers of a Peer-Mediated Intervention to Improve Play in Children with Autism Spectrum Disorder.,"Peer-mediated interventions (PMIs) are often used to support children with autism spectrum disorder (ASD) to develop social skills. However, more investigation is needed to better understand the role of peers as both intervention recipients and models. Sixty-five typically developing peers who participated in a PMI for children with ASD were investigated using a randomised control trial. Play sessions of the dyads were scored using the Test of Playfulness. Results showed a significant moderate intervention effect for the peers from pre- to post-intervention; outcomes for children with ASD were not influenced by peer characteristics; and, the children demonstrated a similar pattern of play interaction. Implications for practice are discussed.Clinical Trials Registry Australian New Zealand Clinical Trials Registry, https://www.anzctr.org.au/ (ACTRN12615000008527; Universal Trial Number: U1111-1165-2708).",2020,Sixty-five typically developing peers who participated in a PMI for children with ASD were investigated using a randomised control trial.,"['children with autism spectrum disorder (ASD', 'Children with Autism Spectrum Disorder', 'Sixty-five typically developing peers who participated in a PMI for children with ASD']","['Peer-Mediated Intervention', 'Peer-mediated interventions (PMIs', 'https://www.anzctr.org.au']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}]",[],65.0,0.0625903,Sixty-five typically developing peers who participated in a PMI for children with ASD were investigated using a randomised control trial.,"[{'ForeName': 'Cally', 'Initials': 'C', 'LastName': 'Kent', 'Affiliation': 'School of Occupational Therapy, Speech Pathology and Social Work, Curtin University, Perth, WA, Australia. cally.smith@curtin.edu.au.'}, {'ForeName': 'Reinie', 'Initials': 'R', 'LastName': 'Cordier', 'Affiliation': 'School of Occupational Therapy, Speech Pathology and Social Work, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Joosten', 'Affiliation': 'School of Allied Health, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wilkes-Gillan', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Bundy', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, NSW, Australia.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04387-6']
3337,31348053,Two-Week Multimodal Prehabilitation Program Improves Perioperative Functional Capability in Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer: A Randomized Controlled Trial.,"BACKGROUND
Patients with lung cancer often experience reduced functional capacity and quality of life after surgery. The current study investigated the impact of a short-term, home-based, multimodal prehabilitation program on perioperative functional capacity in patients undergoing video-assisted thoracoscopic surgery (VATS) lobectomy for nonsmall cell lung cancer (NSCLC).
METHODS
A randomized controlled trial was conducted with 73 patients. Patients in the prehabilitation group (n = 37) received a 2-week multimodal intervention program before surgery, including aerobic and resistance exercises, respiratory training, nutrition counseling with whey protein supplementation, and psychological guidance. Patients in the control group (n = 36) received the usual clinical care. The assessors were blinded to the patient allocation. The primary outcome was perioperative functional capacity measured as the 6-minute walk distance (6MWD), which was assessed at 1 day before and 30 days after surgery. A linear mixed-effects model was built to analyze the perioperative 6MWD. Other outcomes included lung function, disability and psychometric evaluations, length of stay (LOS), short-term recovery quality, postoperative complications, and mortality.
RESULTS
The median duration of prehabilitation was 15 days. The average 6MWD was 60.9 m higher perioperatively in the prehabilitation group compared to the control group (95% confidence interval [CI], 32.4-89.5; P < .001). There were no differences in lung function, disability and psychological assessment, LOS, short-term recovery quality, postoperative complications, and mortality, except for forced vital capacity (FVC; 0.35 L higher in the prehabilitation group, 95% CI, 0.05-0.66; P = .021).
CONCLUSIONS
A 2-week, home-based, multimodal prehabilitation program could produce clinically relevant improvements in perioperative functional capacity in patients undergoing VATS lobectomy for lung cancer.",2020,"There were no differences in lung function, disability and psychological assessment, LOS, short-term recovery quality, postoperative complications, and mortality, except for forced vital capacity (FVC; 0.35 L higher in the prehabilitation group, 95% CI, 0.05-0.66; P = .021).
","['Patients in the prehabilitation group (n = 37', 'patients undergoing', '73 patients', 'Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer', 'patients undergoing VATS lobectomy for lung cancer', 'nonsmall cell lung cancer (NSCLC', 'Patients with lung cancer']","['short-term, home-based, multimodal prehabilitation program', 'usual clinical care', 'multimodal intervention program before surgery, including aerobic and resistance exercises, respiratory training, nutrition counseling with whey protein supplementation, and psychological guidance', 'video-assisted thoracoscopic surgery (VATS) lobectomy']","['median duration of prehabilitation', 'Perioperative Functional Capability', 'lung function, disability and psychological assessment, LOS, short-term recovery quality, postoperative complications, and mortality, except for forced vital capacity', 'perioperative functional capacity measured as the 6-minute walk distance (6MWD', 'functional capacity and quality of life', 'perioperative functional capacity', 'lung function, disability and psychometric evaluations, length of stay (LOS), short-term recovery quality, postoperative complications, and mortality', 'average 6MWD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C4520228', 'cui_str': 'VATS (video-assisted thoracoscopic surgery) lobectomy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0204452', 'cui_str': 'Psychological assessment'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0033920', 'cui_str': 'Psychometrics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.141417,"There were no differences in lung function, disability and psychological assessment, LOS, short-term recovery quality, postoperative complications, and mortality, except for forced vital capacity (FVC; 0.35 L higher in the prehabilitation group, 95% CI, 0.05-0.66; P = .021).
","[{'ForeName': 'Zijia', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'From the *Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China †Central Research Laboratory, Peking Union Medical College Hospital, Beijing, China Departments of ‡Thoracic Surgery §Enteral and Parenteral Nutrition, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Qiu', 'Affiliation': ''}, {'ForeName': 'Lijian', 'Initials': 'L', 'LastName': 'Pei', 'Affiliation': ''}, {'ForeName': 'Yuelun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Yushang', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': ''}, {'ForeName': 'Naixin', 'Initials': 'N', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Shanqing', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004342']
3338,31685813,Effect of topiramate on eating behaviours in Prader-Willi syndrome: TOPRADER double-blind randomised placebo-controlled study.,"Prader-Willi Syndrome (PWS) is a rare genetic syndrome leading to severe behavioural disorders and mild cognitive impairment. The objective of this double-blind randomised placebo-controlled trial was to study the efficacy and tolerance of topiramate on behavioural disorders in patients with PWS. Participants (aged 12-45 years) had genetically confirmed PWS and severe irritability/impulsivity, eating disorders and/or obesity, and skin picking. Thirty-two participants received a placebo (PBO), and 30 participants received topiramate (TOP) (50-200 mg/day) for 8 weeks. The primary outcome was the rate of responders using the Clinical Global Impression-Improvement (CGI-I) scale. The secondary outcome measures included the Aberrant Behaviour Checklist, the Dykens Hyperphagia Questionnaire (DHK), the Self-Injurious Behaviour Scale (SIBS) and the body mass index (BMI). We found no significant difference in the primary outcome (the CGI-I): 9 (30%) patients were very much or much improved in the TOP group compared to 7 (22.6%) patients in the PBO group. However, the DHK behaviour and severity scores improved significantly more over time in patients treated with topiramate versus those receiving a placebo, with a significant dose-effect relationship. DHK scores were also significantly associated with genetic subtypes and hospitalisation status. The effects of topiramate on eating behaviours remained significant after adjusting for genetic subtype and hospitalisation. Topiramate had therefore a significant effect on eating disorders, with a dose-effect relationship. Given the burden of eating disorders in PWS, we believe that topiramate may become the first psychotropic option within the global care of obesity in individuals with PWS.",2019,We found no significant difference in the primary outcome (the CGI-I): 9 (30%) patients were very much or much improved in the TOP group compared to 7 (22.6%) patients in the PBO group.,"['individuals with PWS', 'Participants (aged 12-45 years) had genetically confirmed PWS and severe irritability/impulsivity, eating disorders and/or obesity, and skin picking', 'Prader-Willi syndrome', 'patients with PWS']","['topiramate', 'placebo (PBO', 'Topiramate', 'placebo', 'topiramate (TOP']","['behavioural disorders', 'rate of responders using the Clinical Global Impression-Improvement (CGI-I) scale', 'DHK scores', 'efficacy and tolerance', 'eating disorders', 'Aberrant Behaviour Checklist, the Dykens Hyperphagia Questionnaire (DHK), the Self-Injurious Behaviour Scale (SIBS) and the body mass index (BMI', 'eating behaviours', 'DHK behaviour and severity scores']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0032897', 'cui_str': 'Labhart-Willi-Prader-Fanconi Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0004930', 'cui_str': 'Behavior Disorders'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0443127', 'cui_str': 'Aberrant (qualifier value)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0020505', 'cui_str': 'Polyphagia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}]",32.0,0.349009,We found no significant difference in the primary outcome (the CGI-I): 9 (30%) patients were very much or much improved in the TOP group compared to 7 (22.6%) patients in the PBO group.,"[{'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Consoli', 'Affiliation': ""Département de Psychiatrie de l'Enfant et de l'Adolescent, AP-HP, Groupe-Hospitalier Pitié-Salpêtrière, Paris, France. angele.consoli@aphp.fr.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Çabal Berthoumieu', 'Affiliation': ""Unité d'Endocrinologie, Obésité, Maladies Osseuses, Génétique et Gynécologie Médicale. Centre de Référence du Syndrome de Prader-Willi, Hôpital des Enfants, Toulouse, France.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Raffin', 'Affiliation': ""Département de Psychiatrie de l'Enfant et de l'Adolescent, AP-HP, Groupe-Hospitalier Pitié-Salpêtrière, Paris, France.""}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Thuilleaux', 'Affiliation': 'Assistance-Publique Hôpitaux de Paris (AP-HP), Hopital Marin de Hendaye, French Reference Center for Prader-Willi Syndrome, Hendaye, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Poitou', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (APHP), Pitié-Salpêtrière Hospital, French Reference Center for Prader-Willi Syndrome, Nutrition Department, CRNH Ile de France, F-75013, Paris, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Coupaye', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (APHP), Pitié-Salpêtrière Hospital, French Reference Center for Prader-Willi Syndrome, Nutrition Department, CRNH Ile de France, F-75013, Paris, France.'}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Pinto', 'Affiliation': 'Assistance-Publique Hôpitaux de Paris (AP-HP), Necker Enfants Malades Hospital University Hospital, Pediatric Endocrinology, Diabetology and Gynecology Department, F-75015, Paris, France.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Lebbah', 'Affiliation': 'Assistance-Publique Hôpitaux de Paris (AP-HP), Pitié-Salpêtrière Hospital, Department of Biostatistics, F-75013, Paris, France.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Zahr', 'Affiliation': 'Assistance-Publique Hôpitaux de Paris (AP-HP), Pitié-Salpêtrière Hospital, Department of Pharmacology, F-75013, Paris, France.'}, {'ForeName': 'Maïthé', 'Initials': 'M', 'LastName': 'Tauber', 'Affiliation': ""Unité d'Endocrinologie, Obésité, Maladies Osseuses, Génétique et Gynécologie Médicale. Centre de Référence du Syndrome de Prader-Willi, Hôpital des Enfants, Toulouse, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': ""Département de Psychiatrie de l'Enfant et de l'Adolescent, AP-HP, Groupe-Hospitalier Pitié-Salpêtrière, Paris, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bonnot', 'Affiliation': ""Service Universitaire de Psychiatrie de l'Enfant et de l'Adolescent, CHU de Nantes, Nantes, France.""}]",Translational psychiatry,['10.1038/s41398-019-0597-0']
3339,31995688,Family History of Gastric Cancer and Helicobacter pylori Treatment.,"BACKGROUND
Helicobacter pylori infection and a family history of gastric cancer are the main risk factors for gastric cancer. Whether treatment to eradicate H. pylori can reduce the risk of gastric cancer in persons with a family history of gastric cancer in first-degree relatives is unknown.
METHODS
In this single-center, double-blind, placebo-controlled trial, we screened 3100 first-degree relatives of patients with gastric cancer. We randomly assigned 1838 participants with H. pylori infection to receive either eradication therapy (lansoprazole [30 mg], amoxicillin [1000 mg], and clarithromycin [500 mg], each taken twice daily for 7 days) or placebo. The primary outcome was development of gastric cancer. A prespecified secondary outcome was development of gastric cancer according to H. pylori eradication status, assessed during the follow-up period.
RESULTS
A total of 1676 participants were included in the modified intention-to-treat population for the analysis of the primary outcome (832 in the treatment group and 844 in the placebo group). During a median follow-up of 9.2 years, gastric cancer developed in 10 participants (1.2%) in the treatment group and in 23 (2.7%) in the placebo group (hazard ratio, 0.45; 95% confidence interval [CI], 0.21 to 0.94; P = 0.03 by log-rank test). Among the 10 participants in the treatment group in whom gastric cancer developed, 5 (50.0%) had persistent H. pylori infection. Gastric cancer developed in 0.8% of participants (5 of 608) in whom H. pylori infection was eradicated and in 2.9% of participants (28 of 979) who had persistent infection (hazard ratio, 0.27; 95% CI, 0.10 to 0.70). Adverse events were mild and were more common in the treatment group than in the placebo group (53.0% vs. 19.1%; P<0.001).
CONCLUSIONS
Among persons with H. pylori infection who had a family history of gastric cancer in first-degree relatives, H. pylori eradication treatment reduced the risk of gastric cancer. (Funded by the National Cancer Center, South Korea; ClinicalTrials.gov number, NCT01678027.).",2020,"Gastric cancer developed in 0.8% of participants (5 of 608) in whom H. pylori infection was eradicated and in 2.9% of participants (28 of 979) who had persistent infection (hazard ratio, 0.27; 95% CI, 0.10 to 0.70).","['1838 participants with H. pylori infection to receive either', 'persons with H. pylori infection who had a family history of gastric cancer in first-degree relatives', 'A total of 1676 participants were included in the modified intention-to-treat population for the analysis of the primary outcome (832 in the treatment group and 844 in the placebo group', 'patients with gastric cancer', 'Family History of Gastric Cancer and Helicobacter pylori Treatment']","['placebo', 'eradication therapy (lansoprazole [30 mg], amoxicillin [1000 mg], and clarithromycin']","['risk of gastric cancer', 'persistent H. pylori infection', 'Adverse events', 'development of gastric cancer', 'persistent infection', 'Gastric cancer', 'gastric cancer', 'development of gastric cancer according to H. pylori eradication status, assessed during the follow-up period']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1264606', 'cui_str': 'Persistent infection'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",1838.0,0.379924,"Gastric cancer developed in 0.8% of participants (5 of 608) in whom H. pylori infection was eradicated and in 2.9% of participants (28 of 979) who had persistent infection (hazard ratio, 0.27; 95% CI, 0.10 to 0.70).","[{'ForeName': 'Il Ju', 'Initials': 'IJ', 'LastName': 'Choi', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Chan Gyoo', 'Initials': 'CG', 'LastName': 'Kim', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Jong Yeul', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Young-Il', 'Initials': 'YI', 'LastName': 'Kim', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Myeong-Cherl', 'Initials': 'MC', 'LastName': 'Kook', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Boram', 'Initials': 'B', 'LastName': 'Park', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Jungnam', 'Initials': 'J', 'LastName': 'Joo', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}]",The New England journal of medicine,['10.1056/NEJMoa1909666']
3340,32020530,Cost-Neutral Optimization of Pazopanib Exposure by Splitting Intake Moments: A Prospective Pharmacokinetic Study in Cancer Patients.,"BACKGROUND AND OBJECTIVE
Pazopanib is an oral tyrosine kinase inhibitor used in the treatment of renal cell carcinoma and soft-tissue sarcoma. At the approved dose of 800 mg once daily (QD), 16-20% of patients are being underdosed and at risk of decreased efficacy. This study aimed to show whether splitting intake moments, as a cost-neutral alternative to a dose increase, leads to an increased exposure.
METHODS
We performed a cross-over trial comparing the pharmacokinetics of pazopanib 800 mg QD with pazopanib 400 mg twice daily. Pharmacokinetic sampling was performed at steady-state for both dosing schedules.
RESULTS
Nine evaluable patients were included. At the 800 mg QD dosing schedule, median minimum plasma concentration (C min ), area under the concentration-time curve from 0 to 24 h (AUC 0-24h ), and maximum plasma concentration (C max ) were 23.2 mg/L (interquartile range 18.5-27.6), 773 mg h/L (557-1009), and 40.6 mg/L (36.4-56.4) compared with 41.6 mg/L (30.5-55.8, p = 0.004), 942 mg h/L (885-1419, p = 0.027), and 50.2 mg/L (46.8-72.5, p = 0.074) at 400 mg twice daily. One patient experienced a grade 3 event (i.e., diarrhea).
CONCLUSIONS
This study demonstrates that splitting intake moments of pazopanib leads to a 79% increase in C min , with acceptable tolerability. Therefore, this new dosing schedule offers a cost-neutral opportunity to optimize treatment in patients with low exposure.
CLINICAL TRIAL REGISTRATION
NL6137 ( http://www.trialregister.nl ).",2020,"At the 800 mg QD dosing schedule, median minimum plasma concentration (C min ), area under the concentration-time curve from 0 to 24 h (AUC 0-24h ), and maximum plasma concentration (C max ) were 23.2 mg/L (interquartile range 18.5-27.6), 773 mg ","['Nine evaluable patients were included', 'Cancer Patients', 'renal cell carcinoma and soft-tissue sarcoma', 'patients with low exposure']","['pazopanib 800\xa0mg QD with pazopanib', 'Pazopanib', 'Pazopanib Exposure by Splitting Intake Moments', 'pazopanib']","['maximum plasma concentration\xa0(C max ', 'grade 3 event (i.e., diarrhea', 'median minimum plasma concentration\xa0(C min ), area under the concentration-time curve']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",9.0,0.0638562,"At the 800 mg QD dosing schedule, median minimum plasma concentration (C min ), area under the concentration-time curve from 0 to 24 h (AUC 0-24h ), and maximum plasma concentration (C max ) were 23.2 mg/L (interquartile range 18.5-27.6), 773 mg ","[{'ForeName': 'Stefanie L', 'Initials': 'SL', 'LastName': 'Groenland', 'Affiliation': 'Division of Medical Oncology, Department of Clinical Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. s.groenland@nki.nl.'}, {'ForeName': 'Ruben A G', 'Initials': 'RAG', 'LastName': 'van Eerden', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Remy B', 'Initials': 'RB', 'LastName': 'Verheijen', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'de Vries', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Thijssen', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Rosing', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'Jos H', 'Initials': 'JH', 'LastName': 'Beijnen', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'Stijn L W', 'Initials': 'SLW', 'LastName': 'Koolen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Ron H J', 'Initials': 'RHJ', 'LastName': 'Mathijssen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Alwin D R', 'Initials': 'ADR', 'LastName': 'Huitema', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'Neeltje', 'Initials': 'N', 'LastName': 'Steeghs', 'Affiliation': 'Division of Medical Oncology, Department of Clinical Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical pharmacokinetics,['10.1007/s40262-020-00863-5']
3341,32005192,"TRAAP2 - TRAnexamic Acid for Preventing postpartum hemorrhage after cesarean delivery: a multicenter randomized, doubleblind, placebo- controlled trial - a study protocol.","BACKGROUND
An antifibrinolytic agent that blocks lysine-binding sites on plasminogen molecules, tranexamic acid reduces bleeding-related mortality in women with postpartum hemorrhage (PPH), especially administered fairly soon after delivery. According to the randomized controlled trials thus far reported for PPH prevention after cesarean deliveries (n = 16), women who received tranexamic acid had significantly less postpartum blood loss and no increase in severe adverse effects. These were, however, primarily small single-center studies that had fundamental methodological flaws. Multicenter randomized controlled trials with adequate power are necessary to demonstrate its value persuasively before tranexamic acid goes into widespread use for the prevention of PPH after cesarean deliveries.
METHODS/DESIGN
This study will be a multicenter, double-blind, randomized controlled trial with two parallel groups including 4524 women with cesarean deliveries before or during labor, at a term ≥34 weeks, modeled on our previous study of tranexamic acid administered after vaginal deliveries. Treatment (either tranexamic acid 1 g or placebo) will be administered intravenously just after birth. All women will also receive a prophylactic uterotonic agent. The primary outcome will be the incidence of PPH, defined by a calculated estimated blood loss > 1000 mL or a red blood cell transfusion before day 2 postpartum. This study will have 80% power to show a 20% reduction in the incidence of PPH, from 15.0 to 12.0%.
DISCUSSION
As an, inexpensive, easy to administer drug that can be add to the routine management of cesarean births in delivery rooms, tranexamic acid is a promising candidate for preventing PPH after these births. This large, adequately powered, multicenter randomized placebo-controlled trial seeks to determine if the benefits of the routine prophylactic use of tranexamic acid after cesarean delivery significantly outweigh its risks.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03431805 (February 12, 2018).",2020,"As an, inexpensive, easy to administer drug that can be add to the routine management of cesarean births in delivery rooms, tranexamic acid is a promising candidate for preventing PPH after these births.","['4524 women with cesarean deliveries before or during labor, at a term ≥34\u2009weeks, modeled on our previous study of', 'women with postpartum hemorrhage (PPH', 'postpartum hemorrhage after cesarean delivery', 'administered after vaginal deliveries']","['tranexamic acid', 'prophylactic uterotonic agent', 'TRAAP2 - TRAnexamic Acid', 'placebo', 'tranexamic acid 1\u2009g or placebo']","['severe adverse effects', 'incidence of PPH, defined by a calculated estimated blood loss ', 'postpartum blood loss', 'incidence of PPH']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C3653843', 'cui_str': 'Other uterotonics in ATC'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",4524.0,0.711619,"As an, inexpensive, easy to administer drug that can be add to the routine management of cesarean births in delivery rooms, tranexamic acid is a promising candidate for preventing PPH after these births.","[{'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Sentilhes', 'Affiliation': 'Department of Obstetrics and Gynecology, Bordeaux University Hospital, Place Amélie Raba Léon, 33076, Bordeaux, France. loicsentilhes@hotmail.com.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Daniel', 'Affiliation': 'Department of Obstetrics and Gynecology, Bordeaux University Hospital, Place Amélie Raba Léon, 33076, Bordeaux, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Deneux-Tharaux', 'Affiliation': 'INSERM U1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Center for Epidemiology and Statistics, Sorbonne Paris Cité, DHU Risks in Pregnancy, Paris Descartes University, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pregnancy and childbirth,['10.1186/s12884-019-2718-4']
3342,32023013,Tazarotene 0.045% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris in Adult Males,"BACKGROUND: There has been an increasing interest in gender differences both in the pathogenesis and treatment of acne vulgaris (acne). However, while acne prevalence among adolescents is comparable across sexes, acne is much more common in adult women than in adult men which has been largely ignored. Acne is likely less common in adult men because of the declining rate of sebum secretion observed with increasing age, and yet it can be more severe than in adult women. In addition, adherence to topical medications is especially poor in adult men where tactile and sensory perceptions are low. The first lotion formulation of tazarotene was developed using polymeric emulsion technology to provide an important alternative option to treat these acne patients, especially those who may be sensitive to the irritant effects of other tazarotene formulations.
OBJECTIVE: To evaluate the efficacy and safety of a new tazarotene 0.045% lotion formulation based on polymeric emulsion technology in treating adult male subjects with moderate or severe acne, in comparison with adolescent males treated with the same tazarotene 0.045% lotion.
METHODS: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies in moderate-or-severe acne. Subjects (aged 10 and older, N=1614) were randomized (1:1) to receive tazarotene 0.045% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator’s Global Severity Score [EGSS] and clear or almost clear). Quality of Life was assessed using the validated Acne-QoL scale. Safety, adverse events (AEs) were evaluated throughout; cutaneous tolerability (using a 4-point scale where 0=none and 3=severe) at each study visit.
RESULTS: A total of 268 male subjects (85≥18 years old and 183<18 years old) were treated with tazarotene 0.045% lotion once-daily for 12 weeks. At week 12, percent reductions in inflammatory and noninflammatory lesions with tazarotene 0.045% lotion were 62.3% and 59.5% in the adult male population, compared with 49.4% (P=0.001) and 49.5% (P=0.016) in the adolescent male population. Treatment success was achieved by 33.0% of adult male subjects treated with tazarotene 0.045% lotion, compared with 21.6% in the adolescent male population (P=0.059). Quality of life (as assessed by Acne-QoL domain scores) was better in adolescent males at baseline. Improvements in QoL domain scores were similar to those seen in the overall study population, with greater absolute change in domain scores in the adult males. Improvement in acne symptom scores was significantly greater in adult males (P=0.029). Tazarotene 0.045% lotion was well-tolerated. The number of subjects reporting any AE in the adult male population was 11 (13.6%) compared with 39 (21.4%) in the adolescent male population. There was only one (1.2%) treatment-related AE (application site pain) reported in the adult males compared with 11 (6.0%) in the adolescent males, where the most common treatment-related AEs were application site pain (3.3%), dryness (1.1%), and erythema (1.1%). Mean scores for hyper- and hypopigmentation were very low at baseline in both groups with no appreciable change with treatment.
CONCLUSIONS: Tazarotene 0.045% lotion provides greater efficacy and better tolerability in adult males (above 18 years old) than the adolescent male population with moderate-to-severe acne patients.
J Drugs Dermatol. 2020;19(1):78-85. doi:10.36849/JDD.2020.3979",2020,"Mean scores for hyper- and hypopigmentation were very low at baseline in both groups with no appreciable change with treatment.
","['moderate-or-severe acne', 'Subjects (aged 10 and older, N=1614', 'adult women than in adult men', '268 male subjects (85≥18 years old and 183<18 years old', 'adult males (above 18 years old) than the adolescent male population with moderate-to-severe acne patients', 'Adult Males', 'adult male subjects with moderate or severe acne, in comparison with adolescent males', 'adult men']","['tazarotene 0.045% lotion formulation', 'tazarotene 0.045% lotion or vehicle', 'Tazarotene 0.045% Lotion', 'tazarotene', 'tazarotene 0.045% lotion', 'Tazarotene 0.045% lotion']","['Treatment success', 'acne symptom scores', 'validated Acne-QoL scale', 'efficacy and safety', 'application site pain', 'Mean scores for hyper- and hypopigmentation', 'Quality of Life', 'inflammatory and noninflammatory lesions', 'baseline inflammatory and noninflammatory lesions and treatment success', 'QoL domain scores', 'Evaluator’s Global Severity Score [EGSS] and clear or almost clear', 'Quality of life', 'tolerated', 'number of subjects reporting any AE', 'cutaneous tolerability', 'treatment-related AE (application site pain', 'domain scores', 'Safety, adverse events (AEs', 'efficacy and better tolerability']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0288792', 'cui_str': 'tazarotene'}, {'cui': 'C4517410', 'cui_str': 'Zero point zero four five'}, {'cui': 'C0544341', 'cui_str': 'Lotion (basic dose form)'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0521491', 'cui_str': 'Application site pain (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0162835', 'cui_str': 'Hypomelanosis'}, {'cui': 'C0034380'}, {'cui': 'C0442743', 'cui_str': 'Noninflammatory (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]",1614.0,0.163103,"Mean scores for hyper- and hypopigmentation were very low at baseline in both groups with no appreciable change with treatment.
","[{'ForeName': 'Fran E.', 'Initials': 'FE', 'LastName': 'Cook-Bolden', 'Affiliation': ''}, {'ForeName': 'Michael H.', 'Initials': 'MH', 'LastName': 'Gold', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Guenin', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.3979']
3343,32020733,Acute intense exercise improves sleep and decreases next morning consumption of energy-dense food in adolescent girls with obesity and evening chronotype.,"BACKGROUND
Although adolescence and obesity are related to impaired sleep duration and quality, exercise was admitted as a nonpharmacological treatment for sleep and better control of energy balance.
OBJECTIVES
To investigate the acute effects of intense exercise on sleep and subsequent dietary intake.
METHODS
Sixteen adolescent girls with obesity (age 13.7 ± 1.1 years, weight 82.7 ± 10.2 kg, body mass index (BMI) 30.5 ± 3.4 kg/m 2 , fat mass (FM) 39.2 ± 3.1%, Pittsburgh Sleep Quality Index (PSQI) 8.6 ± 2.8, paediatric daytime sleepiness scale (PDSS) 19.6 ± 5.9) took part in two experimental sessions in a random order: Control (CTL) and Exercise (EX). The two sessions were identical except for a continuous ergocycle exercise bout lasting 40 minutes and performed at 70% VO 2max at the end of the morning of EX. Energy expenditure and sleep were measured by accelerometry and next-morning dietary intake in an ad libitum meal.
RESULTS
Higher sleep duration (P < 0.03) and quality (decreased WASO: P < 0.02; increased SE%: P < 0.02) were observed in EX compared with CTL. This was associated with a nonsignificant decrease in caloric intake (-78 kcal) and a significant decrease in food energy density (P < 0.04), fat, and sugar consumption (respectively, P < 0.02 and P < 0.05) the following morning.
CONCLUSIONS
Acute exercise efficaciously increased sleep duration and quality, resulting in a decrease in subsequent energy-dense food consumption in adolescent girls with obesity.",2020,"RESULTS
Higher sleep duration (P < 0.03) and quality (decreased WASO: P < 0.02; increased SE%: P < 0.02) were observed in EX compared with CTL.","['adolescent girls with obesity and evening chronotype', 'adolescent girls with obesity', 'Sixteen adolescent girls with obesity (age 13.7\u2009±\u20091.1\u2009years, weight 82.7\u2009±\u200910.2 kg, body mass index (BMI) 30.5\u2009±\u20093.4 kg/m 2 , fat mass (FM) 39.2\u2009±\u20093.1%, Pittsburgh Sleep Quality Index (PSQI) 8.6\u2009±\u20092.8, paediatric daytime sleepiness scale (PDSS) 19.6\u2009±\u20095.9) took part in two experimental sessions in a random order']","['Control (CTL) and Exercise (EX', 'intense exercise', 'Acute intense exercise']","['Energy expenditure and sleep', 'quality', 'fat, and sugar consumption', 'food energy density', 'caloric intake', 'sleep duration and quality', 'sleep duration']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517692', 'cui_str': '3.4 (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0222045'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",16.0,0.0378991,"RESULTS
Higher sleep duration (P < 0.03) and quality (decreased WASO: P < 0.02; increased SE%: P < 0.02) were observed in EX compared with CTL.","[{'ForeName': 'Oussama', 'Initials': 'O', 'LastName': 'Saidi', 'Affiliation': 'Laboratoire des Adaptations Métaboliques en conditions Physiologiques et Physiopathologiques (AME2P), Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Rochette', 'Affiliation': 'CHU Clermont-Ferrand, Pédiatrie, Hôpital Estaing, Clermont-Ferrand, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Bovet', 'Affiliation': 'Laboratoire des Adaptations Métaboliques en conditions Physiologiques et Physiopathologiques (AME2P), Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Merlin', 'Affiliation': 'CHU Clermont-Ferrand, Pédiatrie, Hôpital Estaing, Clermont-Ferrand, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Duché', 'Affiliation': ""Laboratoire Impact de l'Activité Physique sur la Santé (IAPS), Université de Toulon, Toulon, France.""}]",Pediatric obesity,['10.1111/ijpo.12613']
3344,31878820,Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4-17 Years) With Focal Seizures.,"OBJECTIVE
To evaluate the safety and tolerability of adjunctive eslicarbazepine acetate (ESL) in pediatric patients (aged 4-17 years) with refractory focal seizures.
METHODS
Pooled safety data from patients aged 4-17 years in Study 208 (NCT01527513) and Study 305 (NCT00988156) were analyzed. Both were randomized, double-blind, placebo-controlled studies of ESL as adjunctive treatment in pediatric patients with refractory focal seizures receiving 1 or 2 antiepileptic drugs. Incidences of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), TEAEs leading to discontinuation, and TEAEs of special interest were evaluated.
RESULTS
The safety population comprised 362 patients (placebo, n = 160; ESL, n = 202). The overall incidence of TEAEs was similar between the ESL (67.8%) and placebo groups (65.6%), with no clear dose-response relationship. The most frequently reported TEAEs with ESL were headache, somnolence, vomiting, and diplopia. Overall incidences of SAEs and TEAEs leading to discontinuation were higher with ESL versus placebo (9.9% vs 5.0% and 5.9% vs 2.5%, respectively). The majority of SAEs with ESL occurred in Study 305. Two deaths were reported, 1 with ESL (0.5%) due to cluster seizures (resulting in herniation of the cerebellar tonsils) and 1 with placebo (0.6%) due to asphyxia. TEAEs related to allergic reaction, hyponatremia, hypothyroidism, cytopenia, seizure exacerbation, cognitive dysfunction, psychiatric disorders, or suicide occurred infrequently (<9%).
CONCLUSION
Adjunctive ESL was generally well tolerated in children aged 4-17 years with focal seizures. The safety profile of ESL in children was comparable to that observed in adults.",2020,"The overall incidence of TEAEs was similar between the ESL (67.8%) and placebo groups (65.6%), with no clear dose-response relationship.","['362 patients (placebo, n = 160; ESL, n = 202', 'pediatric patients (aged 4-17 years) with refractory focal seizures', 'pediatric patients with refractory focal seizures receiving 1 or 2 antiepileptic drugs', 'patients aged 4-17 years in Study 208 (NCT01527513) and Study 305 (NCT00988156) were analyzed', 'Pediatric Patients (Aged 4-17 Years', 'children aged 4-17 years with focal seizures']","['Adjunctive Eslicarbazepine Acetate', 'Adjunctive ESL', 'placebo', 'ESL versus placebo', 'ESL', 'adjunctive eslicarbazepine acetate (ESL']","['Overall incidences of SAEs and TEAEs leading to discontinuation', 'Incidences of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), TEAEs leading to discontinuation, and TEAEs of special interest', 'Safety and Tolerability', 'safety and tolerability', 'cluster seizures', 'overall incidence of TEAEs', 'headache, somnolence, vomiting, and diplopia', 'allergic reaction, hyponatremia, hypothyroidism, cytopenia, seizure exacerbation, cognitive dysfunction, psychiatric disorders, or suicide']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C2725262', 'cui_str': 'eslicarbazepine acetate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0012569', 'cui_str': 'Double Vision'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C2609422', 'cui_str': 'Hypothyroidism (SMQ)'}, {'cui': 'C0010828', 'cui_str': 'Cytopenia (finding)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]",362.0,0.405447,"The overall incidence of TEAEs was similar between the ESL (67.8%) and placebo groups (65.6%), with no clear dose-response relationship.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mintz', 'Affiliation': 'The Center for Neurological and Neurodevelopmental Health (CNNH) and the Clinical Research Center of New Jersey (CRCNJ), Voorhees, NJ, USA.'}, {'ForeName': 'Jesus E', 'Initials': 'JE', 'LastName': 'Pina-Garza', 'Affiliation': ""Centennial Children's Hospital, Nashville, TN, USA.""}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Wolf', 'Affiliation': 'Department of Neurology, Icahn School of Medicine, Mount Sinai Health System, New York, NY, USA.'}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'McGoldrick', 'Affiliation': 'Department of Neurology, Icahn School of Medicine, Mount Sinai Health System, New York, NY, USA.'}, {'ForeName': 'Sergiusz', 'Initials': 'S', 'LastName': 'Józwiak', 'Affiliation': 'Department of Pediatric Neurology, Medical University Warsaw, Warsaw, Poland.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Grinnell', 'Affiliation': 'Sunovion Pharmaceuticals Inc, Marlborough, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cantu', 'Affiliation': 'Sunovion Pharmaceuticals Inc, Marlborough, MA, USA.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Costa', 'Affiliation': 'BIAL-Portela & Cª, SA, Coronado (São Romão e São Mamede), Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Moreira', 'Affiliation': 'BIAL-Portela & Cª, SA, Coronado (São Romão e São Mamede), Portugal.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Sunovion Pharmaceuticals Inc, Marlborough, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blum', 'Affiliation': 'Sunovion Pharmaceuticals Inc, Marlborough, MA, USA.'}]",Journal of child neurology,['10.1177/0883073819890997']
3345,31981227,A Pilot Randomized Controlled Trial to Assess the Impact of Motivational Interviewing on Initiating Behavioral Therapy for Migraine.,"BACKGROUND
Relaxation, biofeedback, and cognitive behavioral therapy are evidence-based behavioral therapies for migraine. Despite such efficacy, research shows that only about half of patients initiate behavioral therapy recommended by their headache specialists.
OBJECTIVE
Motivational interviewing (MI) is a widely used method to help patients explore and overcome ambivalence to enact positive life changes. We tested the hypothesis that telephone-based MI would improve initiation, scheduling, and attending behavioral therapy for migraine.
METHODS
Single-blind randomized controlled trial comparing telephone-based MI to treatment as usual (TAU). Participants were recruited during their appointments with headache specialists at two sites of a New York City medical center.
INCLUSION CRITERIA
ages from 16 to 80, migraine diagnosis by United Council of Neurologic Subspecialty fellowship trained and/or certified headache specialist, and referral for behavioral therapy for prevention in the appointment of recruitment.
EXCLUSION CRITERIA
having done behavioral therapy for migraine in the past year. Participants in the MI group received up to 5 MI calls. TAU participants were called after 3 months for general follow-up data. The prespecified primary outcome was scheduling a behavioral therapy appointment, and secondary outcomes were initiating and attending a behavioral therapy appointment.
RESULTS
76 patients were enrolled and randomized (MI = 36, TAU = 40). At baseline, the mean number of headache days was 12.0 ± 9.0. Self-reported anxiety was present for 36/52 (69.2%) and depression for 30/52 (57.7%). Follow-up assessments were completed for 77.6% (59/76, MI = 32, TAU = 27). The mean number of MI calls per participant was 2.69 ± 1.56 [0 to 5]. There was a greater likelihood of those in the MI group to initiating an appointment (22/32, 68.8% vs 11/27, 40.7%, P = .0309). There were no differences in appointment scheduling or attendance. Reasons stated for not initiating behavioral therapy were lack of time, lack of insurance/funding, prioritizing other treatments, and travel plans.
CONCLUSIONS
Brief telephone-based MI may improve rates of initiation of behavioral therapy for migraine, but other barriers appear to lessen the impact on scheduling and attending behavioral therapy appointments.",2020,"Follow-up assessments were completed for 77.6% (59/76, MI = 32, TAU = 27).","['Participants were recruited during their appointments with headache specialists at two sites of a New York City medical center', 'ages from 16 to 80, migraine diagnosis by United Council of Neurologic Subspecialty fellowship', 'Migraine', '76 patients']","['Motivational interviewing (MI', 'Motivational Interviewing', 'telephone-based MI to treatment as usual (TAU', 'telephone-based MI']","['mean number of MI calls', 'Self-reported anxiety', 'scheduling a behavioral therapy appointment, and secondary outcomes were initiating and attending a behavioral therapy appointment', 'mean number of headache days', 'appointment scheduling or attendance']","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1446911', 'cui_str': 'Scheduling'}]",76.0,0.056722,"Follow-up assessments were completed for 77.6% (59/76, MI = 32, TAU = 27).","[{'ForeName': 'Mia T', 'Initials': 'MT', 'LastName': 'Minen', 'Affiliation': 'Department of Neurology, New York University Langone Health, New York, NY, USA.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Sahyoun', 'Affiliation': 'Department of Neuroscience, Barnard College, Columbia University, New York, NY, USA.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Gopal', 'Affiliation': 'Department of Biology, The City College of New York, City University of New York, New York, NY, USA.'}, {'ForeName': 'Valeriya', 'Initials': 'V', 'LastName': 'Levitan', 'Affiliation': 'Department of Neurology, New York University Langone Health, New York, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pirraglia', 'Affiliation': 'Department of Population, Biostatistics Division, New York University Langone Health, New York, NY, USA.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, New York University Langone Health, New York, NY, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Halpern', 'Affiliation': 'Department of Neurology, New York University Langone Health, New York, NY, USA.'}]",Headache,['10.1111/head.13738']
3346,31340023,Text message alerts to emergency physicians identifying potential study candidates increase clinical trial enrollment.,"Prospective enrollment of research subjects in the fast-paced emergency department (ED) is challenging. We sought to develop a software application to increase real-time clinical trial enrollment during an ED visit. The Prospective Intelligence System for Clinical Emergency Services (PISCES) scans the electronic health record during ED encounters for preselected clinical characteristics of potentially eligible study participants and notifies the treating physician via mobile phone text alerts. PISCES alerts began 3 months into a cluster randomized trial of an electronic health record-based risk stratification tool for pediatric abdominal pain in 11 Northern California EDs. We compared aggregate enrollment before (2577 eligible patients, October 2016 to December 2016) and after (12 049 eligible patients, January 2017 to January 2018) PISCES implementation. Enrollment increased from 10.8% to 21.1% following PISCES implementations (P < .001). PISCES significantly increased study enrollment and can serve as a valuable tool to assist prospective research enrollment in the ED.",2019,Enrollment increased from 10.8% to 21.1% following PISCES implementations (P < .001).,"['2577 eligible patients, October 2016 to December 2016) and after (12\xa0049 eligible patients, January 2017 to January 2018) PISCES implementation', 'pediatric abdominal pain in 11 Northern California EDs']",['electronic health record-based risk stratification tool'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]",[],2577.0,0.0650214,Enrollment increased from 10.8% to 21.1% following PISCES implementations (P < .001).,"[{'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Simon', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, California, USA.'}, {'ForeName': 'Adina S', 'Initials': 'AS', 'LastName': 'Rauchwerger', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, California, USA.'}, {'ForeName': 'Uli K', 'Initials': 'UK', 'LastName': 'Chettipally', 'Affiliation': 'Emergency Department, Kaiser Permanente South San Francisco Medical Center, South San Francisco, California, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Babakhanian', 'Affiliation': 'Asolva Inc, Pasadena, California, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Vinson', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, California, USA.'}, {'ForeName': 'E Margaret', 'Initials': 'EM', 'LastName': 'Warton', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, California, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Reed', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, California, USA.'}, {'ForeName': 'Anupam B', 'Initials': 'AB', 'LastName': 'Kharbanda', 'Affiliation': ""Emergency Department, Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, USA.""}, {'ForeName': 'Elyse O', 'Initials': 'EO', 'LastName': 'Kharbanda', 'Affiliation': 'Division of Research, HealthPartners Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Dustin W', 'Initials': 'DW', 'LastName': 'Ballard', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, California, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz118']
3347,31997387,An Evaluation of Working on What Works (WOWW): A Solution-Focused Intervention for Schools.,"Working on What Works (WOWW) is a manualized, 10-week classroom intervention based on solution-focused brief therapy. This study evaluates WOWW using a randomized experimental, posttest-only design. The study included 30 fourth and fifth grade classrooms, containing 30 teachers and 413 students. Results indicate no significant differences between WOWW and control groups for student internalizing and externalizing behaviors, student-teacher relationships, student academic performance, or teacher sense of efficacy. However, students in the WOWW group had significantly fewer days absent from school compared with the control group. Additionally, teachers' ratings on WOWW classrooms' performance improved significantly more than teachers' ratings on the control classrooms. Results from this study show that WOWW is a feasible intervention for therapists to use in schools and can be implemented across classrooms in both public and private schools. WOWW has potential to improve student attendance and classroom performance, both of which are important areas of concern for schools.",2020,"Additionally, teachers' ratings on WOWW classrooms' performance improved significantly more than teachers' ratings on the control classrooms.","['30 fourth and fifth grade classrooms, containing 30 teachers and 413 students', 'Schools']",[],"[""teachers' ratings on WOWW classrooms' performance"", 'student internalizing and externalizing behaviors, student-teacher relationships, student academic performance, or teacher sense of efficacy']","[{'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],"[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0036373', 'cui_str': 'Academic Performance'}]",30.0,0.023527,"Additionally, teachers' ratings on WOWW classrooms' performance improved significantly more than teachers' ratings on the control classrooms.","[{'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Wallace', 'Affiliation': 'Antioch University Seattle.'}, {'ForeName': 'Audrey Hang', 'Initials': 'AH', 'LastName': 'Hai', 'Affiliation': 'The University of Texas at Austin.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Franklin', 'Affiliation': 'The University of Texas at Austin.'}]",Journal of marital and family therapy,['10.1111/jmft.12424']
3348,31269409,Use of consumer monitors for estimating energy expenditure in youth.,"The purpose of this study was to compare energy expenditure (EE) estimates from 5 consumer physical activity monitors (PAMs) to indirect calorimetry in a sample of youth. Eighty-nine youth (mean (SD); age, 12.3 (3.4) years; 50% female) performed 16 semi-structured activities. Activities were performed in duplicate across 2 visits. Participants wore a Cosmed K4b 2 (criterion for EE), an Apple Watch 2 (left wrist), Mymo Tracker (right hip), and Misfit Shine 2 devices (right hip; right shoe). Participants were randomized to wear a Samsung Gear Fit 2 or a Fitbit Charge 2 on the right wrist. Oxygen consumption was converted to EE by subtracting estimated basal EE (Schofield's equation) from the measured gross EE. EE from each visit was summed across the 2 visit days for comparison with the total EE recorded from the PAMs. All consumer PAMs estimated gross EE, except for the Apple Watch 2 (net Active EE). Paired t tests were used to assess differences between estimated (PAM) and measured (K4b 2 ) EE. Mean absolute percent error (MAPE) was used to assess individual-level error. The Mymo Tracker was not significantly different from measured EE and was within 15.9 kcal of measured kilocalories ( p = 0.764). Mean percent errors ranged from 3.5% (Mymo Tracker) to 48.2% (Apple Watch 2). MAPE ranged from 16.8% (Misfit Shine 2 - right hip) to 49.9% (Mymo Tracker). Novelty Only the Mymo Tracker was not significantly different from measured EE but had the greatest individual error. The Misfit Shine 2 - right hip had the lowest individual error. Caution is warranted when using consumer PAMs in youth for tracking EE.",2020,Mean percent errors ranged from 3.5% (MT) to 48.2% (AW).,"['Youth', 'Eighty-nine youth (mean(SD); age, 12.3(3.4']","['Consumer Monitors', 'wear a Samsung Gear Fit 2 (SG) or a Fitbit Charge 2 (FC']","['Oxygen consumption', 'Mean absolute percent error (MAPE']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0007961', 'cui_str': 'Charges'}]","[{'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}]",89.0,0.0344607,Mean percent errors ranged from 3.5% (MT) to 48.2% (AW).,"[{'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'LaMunion', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, The University of Tennessee, Knoxville, TN 37996, USA.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Blythe', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, The University of Tennessee, Knoxville, TN 37996, USA.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Hibbing', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, The University of Tennessee, Knoxville, TN 37996, USA.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Kaplan', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53211, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Clendenin', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, The University of Tennessee, Knoxville, TN 37996, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Crouter', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, The University of Tennessee, Knoxville, TN 37996, USA.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0129']
3349,31988257,' Immunising' physicians against availability bias in diagnostic reasoning: a randomised controlled experiment.,"BACKGROUND
Diagnostic errors have often been attributed to biases in physicians' reasoning. Interventions to 'immunise' physicians against bias have focused on improving reasoning processes and have largely failed.
OBJECTIVE
To investigate the effect of increasing physicians' relevant knowledge on their susceptibility to availability bias.
DESIGN, SETTINGS AND PARTICIPANTS
Three-phase multicentre randomised experiment with second-year internal medicine residents from eight teaching hospitals in Brazil.
INTERVENTIONS
Immunisation: Physicians diagnosed one of two sets of vignettes (either diseases associated with chronic diarrhoea or with jaundice) and compared/contrasted alternative diagnoses with feedback. Biasing phase (1 week later): Physicians were biased towards either inflammatory bowel disease or viral hepatitis. Diagnostic performance test: All physicians diagnosed three vignettes resembling inflammatory bowel disease, three resembling hepatitis (however, all with different diagnoses). Physicians who increased their knowledge of either chronic diarrhoea or jaundice 1 week earlier were expected to resist the bias attempt.
MAIN OUTCOME MEASUREMENTS
Diagnostic accuracy, measured by test score (range 0-1), computed for subjected-to-bias and not-subjected-to-bias vignettes diagnosed by immunised and not-immunised physicians.
RESULTS
Ninety-one residents participated in the experiment. Diagnostic accuracy differed on subjected-to-bias vignettes, with immunised physicians performing better than non-immunised physicians (0.40 vs 0.24; difference in accuracy 0.16 (95% CI 0.05 to 0.27); p=0.004), but not on not-subjected-to-bias vignettes (0.36 vs 0.41; difference -0.05 (95% CI -0.17 to 0.08); p=0.45). Bias only hampered non-immunised physicians, who performed worse on subjected-to-bias than not-subjected-to-bias vignettes (difference -0.17 (95% CI -0.28 to -0.05); p=0.005); immunised physicians' accuracy did not differ (p=0.56).
CONCLUSIONS
An intervention directed at increasing knowledge of clinical findings that discriminate between similar-looking diseases decreased physicians' susceptibility to availability bias, reducing diagnostic errors, in a simulated setting. Future research needs to examine the degree to which the intervention benefits other disease clusters and performance in clinical practice.
TRIAL REGISTRATION NUMBER
68745917.1.1001.0068.",2020,"Diagnostic accuracy differed on subjected-to-bias vignettes, with immunised physicians performing better than non-immunised physicians (0.40 vs 0.24; difference in accuracy 0.16 (95% CI 0.05 to 0.27); p=0.004), but not on not-subjected-to-bias vignettes (0.36 vs 0.41; difference -0.05 (95% CI -0.17 to 0.08); p=0.45).","['Ninety-one residents participated in the experiment', 'Three-phase multicentre randomised experiment with second-year internal medicine residents from eight teaching hospitals in Brazil']",[],"['Diagnostic accuracy', 'inflammatory bowel disease or viral hepatitis', 'Diagnostic performance test', 'knowledge of either chronic diarrhoea or jaundice', 'chronic diarrhoea or with jaundice']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]",[],"[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0042721', 'cui_str': 'Viral hepatitis (disorder)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0401151', 'cui_str': 'Chronic diarrhea (disorder)'}, {'cui': 'C0022346', 'cui_str': 'Icterus'}]",91.0,0.0645214,"Diagnostic accuracy differed on subjected-to-bias vignettes, with immunised physicians performing better than non-immunised physicians (0.40 vs 0.24; difference in accuracy 0.16 (95% CI 0.05 to 0.27); p=0.004), but not on not-subjected-to-bias vignettes (0.36 vs 0.41; difference -0.05 (95% CI -0.17 to 0.08); p=0.45).","[{'ForeName': 'Sílvia', 'Initials': 'S', 'LastName': 'Mamede', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands s.mamede@erasmusmc.nl.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'de Carvalho-Filho', 'Affiliation': 'Internal Medicine, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Rosa Malena Delbone', 'Initials': 'RMD', 'LastName': 'de Faria', 'Affiliation': 'Propeudeutics, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Franci', 'Affiliation': 'Internal Medicine, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Maria do Patrocinio Tenorio', 'Initials': 'MDPT', 'LastName': 'Nunes', 'Affiliation': 'Internal Medicine, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ligia Maria Cayres', 'Initials': 'LMC', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Medical Education Development, UNIFENAS Medical School, Belo Horizonte, Brazil.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Biegelmeyer', 'Affiliation': 'Internal Medicine, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zwaan', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Henk G', 'Initials': 'HG', 'LastName': 'Schmidt', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}]",BMJ quality & safety,['10.1136/bmjqs-2019-010079']
3350,31505127,Hunger is suppressed after resistance exercise with moderate-load compared to high-load resistance exercise: the potential influence of metabolic and autonomic parameters.,"The purpose of present study was to compare the effects of moderate-load versus high-load resistance exercise (RE) on hunger response, blood lactate, glucose, and autonomic modulation in trained men, and to examine the correlations between these parameters. For this, 11 recreationally resistance-trained males performed 2 randomized trials: moderate-load (6 sets at 70% 1-repetition maximum (1RM) and a 90-s rest interval between sets) and high-load (6 sets at 90% 1RM and a 180-s rest interval between sets) leg-press exercise until movement failure. The subjective rating of hunger was obtained through a visual analog scale. Glucose and lactate concentration were evaluated at rest, immediately after exercise, and 30 min after exercise. Heart rate variability was recorded at baseline and during recovery (until 30 min after exercise) to assess autonomic modulation. The moderate-load condition induced lower subjective hunger ratings than the strength condition immediately after exercise (19.7 ± 16.6 vs 47.3 ± 27.7 mm), 30 min after exercise (33.6 ± 22.9 vs 58.5 ± 29.9 mm), and 60 min after exercise (43.8 ± 26.6 vs 67.8 ± 27.9 mm) ( p < 0.05) and lower area under the curve hunger in relation to the high-load condition ( p < 0.006). Moderate-load RE presented greater lactate concentration and induced slower heart rate variability recovery in relation to high-load RE ( p < 0.05), but no difference was found in glucose, as well as no correlations between any of the variables investigated. In conclusion, moderate-load RE induced lower subjective hunger ratings, slower recovery of the parasympathetic nervous system, and higher lactate concentration in relation to high-load RE, but the metabolic variables were not correlated with hunger suppression.",2020,"Moderate-load RE presented greater lactate concentration and induced slower heart rate variability recovery in relation to high-load (p<0.05), but no difference was found in glucose, as well as no correlations between any of the variables investigated.","['eleven recreationally resistance trained males', 'trained men']",['moderate-load RE versus high-load'],"['Heart rate variability', 'lactate concentration', 'hunger response, blood lactate, glucose, and autonomic modulation', 'subjective hunger ratings', 'autonomic modulation', 'lower AUC hunger', 'Glucose and lactate concentration', 'subjective rating of hunger']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0005768'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",,0.0237128,"Moderate-load RE presented greater lactate concentration and induced slower heart rate variability recovery in relation to high-load (p<0.05), but no difference was found in glucose, as well as no correlations between any of the variables investigated.","[{'ForeName': 'Marcelo Conrado', 'Initials': 'MC', 'LastName': 'Freitas', 'Affiliation': 'Skeletal Muscle Assessment Laboratory (LABSIM), Department of Physical Education, School of Technology and Sciences, São Paulo State University (UNESP), Presidente Prudente, SP 19060-900, Brazil.'}, {'ForeName': 'Valéria Leme Gonçalves', 'Initials': 'VLG', 'LastName': 'Panissa', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, SP 05508-900, Brazil.'}, {'ForeName': 'Sabrina Alves', 'Initials': 'SA', 'LastName': 'Lenquiste', 'Affiliation': 'Department of Nutrition, University of Western São Paulo (UNOESTE), Presidente Prudente, São Paulo, SP 19050-920, Brazil.'}, {'ForeName': 'Fernanda de Maria', 'Initials': 'FM', 'LastName': 'Serra', 'Affiliation': 'Post-Graduate Program in Animal Science, Department of Biomedicine, University of Western São Paulo (UNOESTE), Presidente Prudente, SP 19050-920, Brazil.'}, {'ForeName': 'Caique', 'Initials': 'C', 'LastName': 'Figueiredo', 'Affiliation': 'Exercise and Immunometabolism Research Group, Department of Physical Education, São Paulo State University (UNESP), Presidente Prudente, SP 19060-900, Brazil.'}, {'ForeName': 'Fabio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Department of Physical Education, São Paulo State University (UNESP), Presidente Prudente, SP 19060-900, Brazil.'}, {'ForeName': 'Fabricio Eduardo', 'Initials': 'FE', 'LastName': 'Rossi', 'Affiliation': 'Immunometabolism of Skeletal Muscle and Exercise Research Group, Federal University of Piauí (UFPI), Teresina, PI 64049-550, Brazil.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0086']
3351,31872349,"Rationale and design of ""Can Very Low Dose Rivaroxaban (VLDR) in addition to dual antiplatelet therapy improve thrombotic status in acute coronary syndrome (VaLiDate-R)"" study : A randomised trial modulating endogenous fibrinolysis in patients with acute coronary syndrome.","Impaired endogenous fibrinolysis is novel biomarker that can identify patients with ACS at increased cardiovascular risk. The addition of Very Low Dose Rivaroxaban (VLDR) to dual antiplatelet therapy has been shown to reduce cardiovascular events but at a cost of increased bleeding and is therefore not suitable for all-comers. Targeted additional pharmacotherapy with VLDR to improve endogenous fibrinolysis may improve outcomes in high-risk patients, whilst avoiding unnecessary bleeding in low-risk individuals. The VaLiDate-R study (ClinicalTrials.gov Identifier: NCT03775746, EudraCT: 2018-003299-11) is an investigator-initiated, randomised, open-label, single centre trial comparing the effect of 3 antithrombotic regimens on endogenous fibrinolysis in 150 patients with ACS. Subjects whose screening blood test shows impaired fibrinolytic status (lysis time > 2000s), will be randomised to one of 3 treatment arms in a 1:1:1 ratio: clopidogrel 75 mg daily (Group 1); clopidogrel 75 mg daily plus rivaroxaban 2.5 mg twice daily (Group 2); ticagrelor 90 mg twice daily (Group 3), in addition to aspirin 75 mg daily. Rivaroxaban will be given for 30 days. Fibrinolytic status will be assessed during admission and at 2, 4 and 8 weeks. The primary outcome measure is the change in fibrinolysis time from admission to 4 weeks follow-up, using the Global Thrombosis Test. If VLDR can improve endogenous fibrinolysis in ACS, future large-scale studies would be required to assess whether targeted use of VLDR in patients with ACS and impaired fibrinolysis can translate into improved clinical outcomes, with reduction in major adverse cardiovascular events in this high-risk cohort.",2020,"Subjects whose screening blood test shows impaired fibrinolytic status (lysis time > 2000s), will be randomised to one of 3 treatment arms in a 1:1:1 ratio: clopidogrel 75 mg daily (Group 1); clopidogrel 75 mg daily plus rivaroxaban 2.5 mg twice daily (Group 2); ticagrelor 90 mg twice daily (Group 3), in addition to aspirin 75 mg daily.","['patients with acute coronary syndrome', '150 patients with ACS', 'acute coronary syndrome (VaLiDate-R', 'patients with ACS at increased cardiovascular risk']","['clopidogrel', 'aspirin 75\xa0mg daily', 'endogenous fibrinolysis', 'Rivaroxaban', 'VLDR', 'clopidogrel 75\xa0mg daily plus rivaroxaban', 'ticagrelor', 'Rivaroxaban (VLDR', 'antithrombotic regimens']","['thrombotic status', 'change in fibrinolysis time from admission to 4\xa0weeks follow-up, using the Global Thrombosis Test', 'cardiovascular events', 'Fibrinolytic status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0983879', 'cui_str': 'Aspirin 75 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1124675', 'cui_str': 'clopidogrel 75 MG'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0200464', 'cui_str': 'Clot Lysis Time'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",150.0,0.104124,"Subjects whose screening blood test shows impaired fibrinolytic status (lysis time > 2000s), will be randomised to one of 3 treatment arms in a 1:1:1 ratio: clopidogrel 75 mg daily (Group 1); clopidogrel 75 mg daily plus rivaroxaban 2.5 mg twice daily (Group 2); ticagrelor 90 mg twice daily (Group 3), in addition to aspirin 75 mg daily.","[{'ForeName': 'Ying X', 'Initials': 'YX', 'LastName': 'Gue', 'Affiliation': 'Department of Postgraduate Medicine, University of Hertfordshire, Hatfield, UK.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Kanji', 'Affiliation': 'Cardiology Department, East and North Hertfordshire NHS Trust, Hertfordshire, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Wellsted', 'Affiliation': 'Department of Postgraduate Medicine, University of Hertfordshire, Hatfield, UK.'}, {'ForeName': 'Manivannan', 'Initials': 'M', 'LastName': 'Srinivasan', 'Affiliation': 'Cardiology Department, East and North Hertfordshire NHS Trust, Hertfordshire, UK.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Wyatt', 'Affiliation': 'Department of Postgraduate Medicine, University of Hertfordshire, Hatfield, UK.'}, {'ForeName': 'Diana A', 'Initials': 'DA', 'LastName': 'Gorog', 'Affiliation': 'Department of Postgraduate Medicine, University of Hertfordshire, Hatfield, UK. d.gorog@imperial.ac.uk.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-019-02014-5']
3352,31993819,"Doxapram as an additive to propofol sedation for endoscopic retrograde cholangiopancreatography: a placebo-controlled, randomized, double-blinded study.","BACKGROUND
Endoscopic retrograde cholangiopancreatography (ERCP) requires moderate to deep sedation, usually with propofol. Adverse effects of propofol sedation are relatively common, such as respiratory and cardiovascular depression. This study was conducted to determine if doxapram, a respiratory stimulant, could be used to reduce the incidence of respiratory depression.
METHODS
This is a single-center, prospective randomized double-blind study performed in the endoscopy unit of Helsinki University Central Hospital. 56 patients were randomized in a 1:1 ratio to either receive doxapram as an initial 1 mg/kg bolus and an infusion of 1 mg/kg/h (group DOX) or placebo (group P) during propofol sedation for ERCP. Main outcome measures were apneic episodes and hypoxemia (SpO 2 < 90%). Mann-Whitney test for continuous variables and Fisher's exact test for discrete variables were used and mixed effects modeling to take into account repeated measurements on the same subject and comparing both changes within a group as a function of time and between the groups.
RESULTS
There were no statistically significant differences in apneic episodes (p = 0.18) or hypoxemia (p = 0.53) between the groups. There was a statistically significant rise in etCO 2 levels in both groups, but the rise was smaller in group P. There was a statistically significant rise in Bispectral Index (p = 0.002) but not modified Observer's Assessment of Agitation/Sedation (p = 0.21) in group P. There were no statistically significant differences in any other measured parameters.
CONCLUSIONS
Doxapram was not effective in reducing respiratory depression caused by deep propofol sedation during ERCP. Further studies are warranted using different sedation protocols and dosing regimens. Clinical trial registration ClinicalTrials.gov ID NCT02171910.",2020,"There was a statistically significant rise in etCO 2 levels in both groups, but the rise was smaller in group P. There was a statistically significant rise in Bispectral Index (p = 0.002) but not modified Observer's Assessment of Agitation/Sedation (p = 0.21) in group","['endoscopy unit of Helsinki University Central Hospital', '56 patients']","['propofol sedation for ERCP', 'propofol sedation', 'Doxapram', 'placebo', 'propofol', 'doxapram as an initial 1\xa0mg/kg bolus and an infusion of 1\xa0mg/kg/h (group DOX) or placebo', 'Endoscopic retrograde cholangiopancreatography (ERCP']","['etCO 2 levels', 'apneic episodes and hypoxemia', 'Agitation/Sedation', 'Bispectral Index', 'hypoxemia', 'respiratory depression', 'apneic episodes']","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0013084', 'cui_str': 'Doxapram'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}]",56.0,0.3733,"There was a statistically significant rise in etCO 2 levels in both groups, but the rise was smaller in group P. There was a statistically significant rise in Bispectral Index (p = 0.002) but not modified Observer's Assessment of Agitation/Sedation (p = 0.21) in group","[{'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Jokelainen', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, South Karelia Central Hospital, Valto Käkelän katu 1, 53130, Lappeenranta, Finland. jarno.jokelainen@gmail.com.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Belozerskikh', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Mustonen', 'Affiliation': 'University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Udd', 'Affiliation': 'University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Kylänpää', 'Affiliation': 'University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Lindström', 'Affiliation': 'University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Mazanikov', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pöyhiä', 'Affiliation': 'University of Helsinki, Helsinki, Finland.'}]",Surgical endoscopy,['10.1007/s00464-019-07344-2']
3353,32017413,Effect of a hand massage with a warm hand bath on sleep and relaxation in elderly women with disturbance of sleep: A crossover trial.,"AIM
The purpose of the present study was to clarify the effects of a hand massage with a warm hand bath on sleep, autonomic nervous activity, subjective sleep quality, and relaxation in elderly women with sleep disturbance.
METHODS
A crossover design was used. Participants were assigned to two groups: a structured control first and intervention second condition, or an intervention first and control second condition. The sleep index as assessed by actigraphy, autonomic nervous activity, subjective sleep quality, and relaxation was then recorded.
RESULTS
The mean age of the participants was 77.8 ± 6.8 years (n = 28). According to the actigraph, the intervention day showed significantly improved sleep efficiency (p = .048) and sleep onset latency (p = .015). Regarding autonomic nervous activity, heart rate decreased significantly after the intervention (p = .001), but no significant differences were seen in the other indexes. Subjective sleep quality, which was investigated using the middle-age and aged version of the Oguri-Shirakawa-Azumi sleep questionnaire, was significantly higher after the intervention for four out of five factors. Subjective comfort and relaxation were significantly higher after the intervention for all items.
CONCLUSIONS
A hand massage with a warm hand bath in the evening improved sleep efficiency and sleep onset latency in elderly women with sleep disturbance. These results suggest that a hand bath and massage may improve subjective sleep quality and relaxation.",2020,"According to the actigraph, the intervention day showed significantly improved sleep efficiency (p = .048) and sleep onset latency (p = .015).","['elderly women with disturbance of sleep', 'The mean age of the participants was 77.8\u2009±\u20096.8\u2009years (n = 28', 'elderly women with sleep disturbance']","['structured control first and intervention second condition, or an intervention first and control second condition', 'hand massage with a warm hand bath']","['sleep efficiency', 'autonomic nervous activity, heart rate', 'subjective sleep quality and relaxation', 'Subjective sleep quality', 'Subjective comfort and relaxation', 'sleep onset latency', 'sleep efficiency and sleep onset latency', 'sleep, autonomic nervous activity, subjective sleep quality, and relaxation', 'sleep index as assessed by actigraphy, autonomic nervous activity, subjective sleep quality, and relaxation']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0424744', 'cui_str': 'Warm hands (finding)'}, {'cui': 'C0150141'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}]",28.0,0.0249553,"According to the actigraph, the intervention day showed significantly improved sleep efficiency (p = .048) and sleep onset latency (p = .015).","[{'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Kudo', 'Affiliation': 'Department of Basic Nursing, Akita University Graduate School of Health Sciences, Akita, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Sasaki', 'Affiliation': 'Department of Basic Nursing, Akita University Graduate School of Health Sciences, Akita, Japan.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12327']
3354,32016520,A novel preoperative scoring system to predict technical difficulty in laparoscopic splenectomy for non-traumatic diseases.,"BACKGROUND
Laparoscopic splenectomy (LS) has been proven to be a safe and advantageous procedure. To ensure that resections of appropriate difficulty are selected, an objective preoperative grading of difficulty is required. We aimed to develop a predictive difficulty grading of LS based on intraoperative complications.
METHODS
A total of 272 non-traumatic patients who underwent LS were identified from a regional medical center. Patients were randomized into a training cohort (n = 222) and a validation cohort (n = 50). Data on demographics, medical and surgical history, operative and pathological characteristics, and postoperative outcome details were collected. Univariate and multivariate analyses of risk factors for intraoperative complications were performed to develop a difficulty scoring system. The Spearman correlation coefficient was used to evaluate the relationship between the difficulty grading score and intraoperative outcomes. Receiver operating characteristic (ROC) curve was used to evaluate the discriminatory power of this scoring system.
RESULTS
Three preoperative factors (spleen weight, esophagogastric varices, and INR) had a significant effect on operative time, bleeding, and conversion to open surgery. We created a difficulty grading score with three levels of difficulty: low (≤ 4 points), medium (5-6 points), and high (≥ 7 points), based on the three preoperative parameters. The correlation was highly significant (P < 0.01) according to Spearman's correlation. The area under the ROC curve was 0.695 (95% CI 0.630-0.755). The external validation showed significant correlations with the present model, with an AUC of 0.725 (95% CI 0.580-0.842). The comparison between our difficulty score and the previous grading system in the 272-patient cohort presented a significant difference in the AUC (0.701, 95% CI 0.643-0.755 vs. 0.644, 95% CI 0.584-0.701, P = 0.0452).
CONCLUSION
The present difficulty scoring system, based on preoperative factors, has good performance in predicting the risk of intraoperative complications of LS and could be helpful for enabling appropriate case selection with respect to the current experience of a surgeon.",2020,"The present difficulty scoring system, based on preoperative factors, has good performance in predicting the risk of intraoperative complications of LS and could be helpful for enabling appropriate case selection with respect to the current experience of a surgeon.",['272 non-traumatic patients who underwent LS were identified from a regional medical center'],"['Laparoscopic splenectomy (LS', 'laparoscopic splenectomy']","['operative time, bleeding, and conversion to open surgery', 'area under the ROC curve', 'preoperative factors (spleen weight, esophagogastric varices, and INR']","[{'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0037995', 'cui_str': 'Splenectomy'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C3494226', 'cui_str': 'Conversion to an Open Surgical Procedure'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0037993', 'cui_str': 'Spleen'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric (qualifier value)'}, {'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C0525032', 'cui_str': 'INR'}]",272.0,0.0431899,"The present difficulty scoring system, based on preoperative factors, has good performance in predicting the risk of intraoperative complications of LS and could be helpful for enabling appropriate case selection with respect to the current experience of a surgeon.","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of Hepatobiliary Surgery, First Affiliated Hospital of Xi'an Jiaotong University, No. 277 West Yan-ta Road, Xi'an, 710061, Shaanxi, P. R. China.""}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Zhongshan Hospital, Fudan University, Shanghai, 200030, China.'}, {'ForeName': 'Hong-Fan', 'Initials': 'HF', 'LastName': 'Ding', 'Affiliation': ""Department of Hepatobiliary Surgery, First Affiliated Hospital of Xi'an Jiaotong University, No. 277 West Yan-ta Road, Xi'an, 710061, Shaanxi, P. R. China.""}, {'ForeName': 'Ding-Hui', 'Initials': 'DH', 'LastName': 'Dong', 'Affiliation': ""Department of Hepatobiliary Surgery, First Affiliated Hospital of Xi'an Jiaotong University, No. 277 West Yan-ta Road, Xi'an, 710061, Shaanxi, P. R. China.""}, {'ForeName': 'Xu-Feng', 'Initials': 'XF', 'LastName': 'Zhang', 'Affiliation': ""Department of Hepatobiliary Surgery, First Affiliated Hospital of Xi'an Jiaotong University, No. 277 West Yan-ta Road, Xi'an, 710061, Shaanxi, P. R. China.""}, {'ForeName': 'Xue-Min', 'Initials': 'XM', 'LastName': 'Liu', 'Affiliation': ""Department of Hepatobiliary Surgery, First Affiliated Hospital of Xi'an Jiaotong University, No. 277 West Yan-ta Road, Xi'an, 710061, Shaanxi, P. R. China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': ""Department of Hepatobiliary Surgery, First Affiliated Hospital of Xi'an Jiaotong University, No. 277 West Yan-ta Road, Xi'an, 710061, Shaanxi, P. R. China.""}, {'ForeName': 'Jun-Xi', 'Initials': 'JX', 'LastName': 'Xiang', 'Affiliation': ""Department of Hepatobiliary Surgery, First Affiliated Hospital of Xi'an Jiaotong University, No. 277 West Yan-ta Road, Xi'an, 710061, Shaanxi, P. R. China. xjx123@xjtu.edu.cn.""}]",Surgical endoscopy,['10.1007/s00464-019-07327-3']
3355,31714592,Final report of a prospective randomized study on thoracic radiotherapy target volume for limited-stage small cell lung cancer with radiation dosimetric analyses.,"BACKGROUND
The thoracic radiotherapy (TRT) target volume for limited-stage small-cell lung cancer (SCLC) has been controversial for decades. In this report, the final results of a prospective randomized trial on the TRT target volume before and after induction chemotherapy are presented.
METHODS
After 2 cycles of etoposide and cisplatin, patients arm were randomized to receive TRT to the postchemotherapy or prechemotherapy tumor volume in a study arm and a control arm. Involved-field radiotherapy was received in both arms. TRT consisted of 1.5 grays (Gy) twice daily in 30 fractions to up to a total dose of 45 Gy. Lymph node regions were contoured, and intentional and incidental radiation doses were recorded.
RESULTS
The study was halted early because of slow accrual. Between 2002 and 2017, 159 and 150 patients were randomized to the study arm or the control arm, respectively; and 21.4% and 19.1% of patients, respectively, were staged using positron emission tomography/computed tomography (P = .31). With a median follow-up of 54.1 months (range, 19.9-165.0 months) in survivors, the 3-year local/regional progression-free probability was 58.2% and 65.5% in the study and control arms, respectively (P = .44), and the absolute difference was -7.3% (95% CI, -18.2%, 3.7%). In the study and control arms, the median overall survival was 21.9 months and 26.6 months, respectively, and the 5-year overall survival rate was 22.8% and 28.1%, respectively (P = .26). Grade 3 esophagitis was observed in 5.9% of patients in the study arm versus 15.5% of those in the control arm (P = .01). The isolated out-of-field failure rate was 2.6% in the study arm versus 4.1% in the control arm (P = .46), and all such failures were located in the supraclavicular fossa or contralateral hilum. The regions 7, 3P, 4L, 6, 4R, 5, and 2L received incidental radiation doses >30 Gy.
CONCLUSIONS
TRT could be limited to the postchemotherapy tumor volume, and involved-field radiotherapy could be routinely applied for limited-stage SCLC.",2020,"The isolated out-of-field failure rate was 2.6% in the study arm versus 4.1% in the control arm (P = .46), and all such failures were located in the supraclavicular fossa or contralateral hilum.","['limited-stage small-cell lung cancer', 'Between 2002 and 2017, 159 and 150 patients']","['postchemotherapy or prechemotherapy', 'thoracic radiotherapy (TRT', 'TRT', 'positron emission tomography/computed tomography', 'etoposide and cisplatin', 'thoracic radiotherapy']","['median overall survival', '3-year local/regional progression-free probability', '5-year overall survival rate', 'Grade 3 esophagitis']","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}]",,0.103374,"The isolated out-of-field failure rate was 2.6% in the study arm versus 4.1% in the control arm (P = .46), and all such failures were located in the supraclavicular fossa or contralateral hilum.","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yu-Jin', 'Initials': 'YJ', 'LastName': 'Xu', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Hui-Neng', 'Initials': 'HN', 'LastName': 'Zhu', 'Affiliation': 'Department of Pathology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jin-Shi', 'Initials': 'JS', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Clinical Trials Center, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Hong-Lian', 'Initials': 'HL', 'LastName': 'Ma', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Xiao-Ling', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Zheng-Bo', 'Initials': 'ZB', 'LastName': 'Song', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Hua-Rong', 'Initials': 'HR', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fang', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Meng-Yuan', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Bai-Qiang', 'Initials': 'BQ', 'LastName': 'Dong', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Pathology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Pathology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Xin-Min', 'Initials': 'XM', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hong', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yi-Ping', 'Initials': 'YP', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Peng-Cheng', 'Initials': 'PC', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'You-Hua', 'Initials': 'YH', 'LastName': 'Jiang', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Xin-Ming', 'Initials': 'XM', 'LastName': 'Zhou', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Qi-Xun', 'Initials': 'QX', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Wen-Yong', 'Initials': 'WY', 'LastName': 'Sun', 'Affiliation': 'Department of Pathology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Wei-Min', 'Initials': 'WM', 'LastName': 'Mao', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}]",Cancer,['10.1002/cncr.32586']
3356,31892654,"'Am I really hungry?' A qualitative exploration of patients' experience, adherence and behaviour change during hunger training: a pilot study.","OBJECTIVES
Hunger training (HT) is an intervention designed to teach people to eat according to their hunger by connecting physical symptoms of appetite with glucose levels. HT is most effective for weight loss, and improving eating behaviours when adherence is high. However, adherence is a challenge that should be explored prior to wider dissemination. The aim of this study was to explore participants' experience and self-reported adherence and behaviour change related to HT.
DESIGN
A qualitative study, nested within a randomised controlled pilot study of two different methods of monitoring glucose during HT. Semistructured interviews were audio-recorded, transcribed verbatim and analysed thematically using a phenomenological approach.
SETTING
Single-centre study with participants recruited from the local area.
PARTICIPANTS
40 participants began the pilot study and 38 participants (52.6% women) remained at 1 month and completed interviews.
RESULTS
Most participants felt they were able to match their hunger to their glucose levels by the end of the intervention. The main adherence barriers were the social pressure to eat, lack of time and lack of flexibility in participants' meal schedules. Common adherence enablers were having a set routine, social support and accountability. Participants described increased awareness of hungry versus non-hungry eating and better cognition of feelings of hunger and satiety as a result of the intervention, which in turn led to changes of food choice, portion size and adjusted meal timing and frequency.
CONCLUSIONS
Findings show that HT is acceptable from a patient perspective, and results can be used to inform the translation of HT programme to healthcare settings.
TRIAL REGISTRATION NUMBER
ACTRN12618001257257.",2019,"Participants described increased awareness of hungry versus non-hungry eating and better cognition of feelings of hunger and satiety as a result of the intervention, which in turn led to changes of food choice, portion size and adjusted meal timing and frequency.
","[""patients' experience, adherence and behaviour change during hunger training"", 'Single-centre study with participants recruited from the local area', '40 participants began the pilot study and 38 participants (52.6% women) remained at 1\u2009month and completed interviews']","['HT', 'Hunger training (HT', 'monitoring glucose during HT']","['awareness of hungry versus non-hungry eating and better cognition of feelings of hunger and satiety', 'social pressure to eat, lack of time and lack of flexibility']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",40.0,0.054161,"Participants described increased awareness of hungry versus non-hungry eating and better cognition of feelings of hunger and satiety as a result of the intervention, which in turn led to changes of food choice, portion size and adjusted meal timing and frequency.
","[{'ForeName': 'Willemijn E', 'Initials': 'WE', 'LastName': 'de Bruin', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Aimee L', 'Initials': 'AL', 'LastName': 'Ward', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Rachael W', 'Initials': 'RW', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Jospe', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand michelle.jospe@otago.ac.nz.'}]",BMJ open,['10.1136/bmjopen-2019-032248']
3357,31985914,Tazarotene 0.045% Lotion for Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris: Results from Two Phase 3 Trials,"BACKGROUND: Tazarotene has been extensively studied in clinical trials and is widely used to treat acne vulgaris (acne), with data suggesting that is one of the most potent topical retinoids. Irritation from the cream, foam, and gel formulations has limited its use in clinical practice.
OBJECTIVE: To assess the efficacy, safety, and tolerability of a unique tazarotene 0.045% lotion formulation based on polymeric emulsion technology in subjects with moderate or severe acne. Methods: A total of 1614 subjects, 9 years and older were randomized to receive tazarotene 0.045% lotion or vehicle in two identical double-blind, randomized, vehicle-controlled 12-week studies evaluating safety and efficacy (inflammatory [papules and pustules] and noninflammatory [comedonal] lesion counts and using Evaluator Global Severity Scores [EGSS]). Treatment success was defined as at least a 2-grade improvement in EGSS and ‘clear’/’almost clear’ and efficacy assessed through reduction in lesion counts. In addition, patients completed a validated Acne-Specific Quality of Life (Acne-QoL) questionnaire. Safety, adverse events (AEs), and cutaneous tolerability were assessed throughout.
RESULTS: Tazarotene 0.045% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and noninflammatory lesion counts at week 12. Mean percent reductions in inflammatory and noninflammatory lesions were 55.5% and 51.4% (Study 1, both P<0.001 versus vehicle [45.7% and 41.5%, respectively]) and 59.5% and 60.0% (Study 2, both P<0.001 versus vehicle [49.0% and 41.6%, respectively]), with tazarotene 0.1% cream at week 12. Treatment success was achieved by 25.5% (Study 1) and 29.6% (Study 2) of subjects treated with tazarotene 0.045% lotion (both P<0.001 versus vehicle [13.0% and 17.3%, respectively]). Improvements in QoL domain scores were consistently greater with tazarotene. Tazarotene 0.045% lotion was well-tolerated. The most common treatment-related AEs were application site pain (5.3%), dryness (3.6%), and exfoliation (2.1%).
CONCLUSION: Tazarotene 0.045% lotion provides statistically significant greater efficacy than vehicle in terms of lesion reduction and treatment success, with a highly favorable safety and tolerability profile in moderate-to-severe acne patients.
JJ Drugs Dermatol. 2020;19(1):70-77. doi:10.36849/JDD.2020.3977",2020,"Tazarotene 0.045% lotion provides statistically significant greater efficacy than vehicle in terms of lesion reduction and treatment success, with a highly favorable safety and tolerability profile in moderate-to-severe acne patients.
","['subjects with moderate or severe acne', '1614 subjects, 9 years and older', 'Moderate-to-Severe Acne Vulgaris']","['tazarotene 0.045% lotion formulation', 'tazarotene 0.045% lotion or vehicle', 'Tazarotene 0.045% Lotion', 'Tazarotene', 'tazarotene', 'Tazarotene 0.045% lotion']","['Treatment success', 'validated Acne-Specific Quality of Life (Acne-QoL) questionnaire', 'application site pain', 'inflammatory and noninflammatory lesion counts', 'inflammatory and noninflammatory lesions', 'efficacy, safety, and tolerability', 'tolerated', 'dryness', '2-grade improvement in EGSS and ‘clear’/’almost clear’ and efficacy assessed through reduction in lesion counts', 'Safety, adverse events (AEs), and cutaneous tolerability', 'QoL domain scores', 'safety and efficacy (inflammatory [papules and pustules] and noninflammatory [comedonal] lesion counts and using Evaluator Global Severity Scores [EGSS']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}]","[{'cui': 'C0288792', 'cui_str': 'tazarotene'}, {'cui': 'C4517410', 'cui_str': 'Zero point zero four five'}, {'cui': 'C0544341', 'cui_str': 'Lotion (basic dose form)'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0521491', 'cui_str': 'Application site pain (finding)'}, {'cui': 'C0442743', 'cui_str': 'Noninflammatory (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332563', 'cui_str': 'Papule (morphologic abnormality)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}]",1614.0,0.182693,"Tazarotene 0.045% lotion provides statistically significant greater efficacy than vehicle in terms of lesion reduction and treatment success, with a highly favorable safety and tolerability profile in moderate-to-severe acne patients.
","[{'ForeName': 'Emil A.', 'Initials': 'EA', 'LastName': 'Tanghetti', 'Affiliation': ''}, {'ForeName': 'William P.', 'Initials': 'WP', 'LastName': 'Werschler', 'Affiliation': ''}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Lain', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Guenin', 'Affiliation': ''}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Radhakrishnan', 'Initials': 'R', 'LastName': 'Pillai', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.3977']
3358,32183741,"Effect of mirabegron on cognitive function in elderly patients with overactive bladder: MoCA results from a phase 4 randomized, placebo-controlled study (PILLAR).","BACKGROUND
Antimuscarinics are often used for treatment of overactive bladder (OAB), but exposure to medications such as antimuscarinics that have anticholinergic properties has been linked to adverse cognitive effects. A phase 4 placebo-controlled study (PILLAR; NCT02216214) described the efficacy and safety of mirabegron, a β 3 -adrenoreceptor agonist, for treatment of wet OAB in patients aged ≥65 years. This pre-planned analysis aimed to measure differences in cognitive function between mirabegron and placebo, using a rapid screening instrument for mild cognitive impairment: the Montreal Cognitive Assessment (MoCA).
METHODS
Outpatients aged ≥65 years with wet OAB were randomized 1:1 to mirabegron or placebo, stratified by age (<75/≥75 years). There were no exclusion criteria regarding cognitive status. Patients randomized to mirabegron initially received 25 mg/day with an optional increase to 50 mg/day after week 4/8 based on patient/investigator discretion. The MoCA was administered at baseline and end of treatment (EoT, week 12). The study protocol was Independent Ethics Committee/Institutional Review Board-approved.
RESULTS
Of the 887 randomized patients who received ≥1 dose of study drug, 72.3% were female, 79.5% were white, and 28.1% were aged ≥75 years. All patients had ≥1 comorbidity and 94.3% were receiving ≥1 concomitant medication. One third of patients had a history of psychiatric disorders, the most common being depression (17.2%), insomnia (15.7%), and anxiety (11.4%). Baseline mean (standard error, SE) MoCA total scores were 26.9 (0.1) and 26.8 (0.1) in the mirabegron and placebo groups, respectively. Among patients with MoCA data available at baseline/EoT, 27.1% (115/425) and 25.8% (106/411) of mirabegron and placebo group patients, respectively, had impaired cognitive function at baseline (MoCA total score <26). There was no statistically significant change in adjusted mean (SE) MoCA total score from baseline to EoT in the mirabegron group (-0.2 [0.1]) or the placebo group (-0.1 [0.1]).
CONCLUSIONS
Treatment with mirabegron for 12 weeks did not contribute to drug-related cognitive side effects in patients aged ≥65 years, as measured by the MoCA. Furthermore, the pattern of change in cognition over time in an older OAB trial population does not appear to differ from that of subjects receiving placebo.
TRIAL REGISTRATION
NCT02216214 (prospectively registered August 13, 2014).",2020,"There was no statistically significant change in adjusted mean (SE) MoCA total score from baseline to EoT in the mirabegron group (-0.2 [0.1]) or the placebo group (-0.1 [0.1]).
","['patients aged ≥65\u2009years', 'All patients had ≥1 comorbidity and 94.3% were receiving ≥1 concomitant medication', '887 randomized patients who received ≥1 dose of study drug, 72.3% were female, 79.5% were white, and 28.1% were aged ≥75\u2009years', 'mild cognitive impairment', 'Outpatients aged ≥65\u2009years with wet OAB', 'elderly patients with overactive bladder']","['mirabegron or placebo', 'placebo', 'mirabegron']","['cognitive function', 'Baseline mean (standard error, SE', 'MoCA total scores', 'insomnia', 'history of psychiatric disorders', 'adjusted mean (SE) MoCA total score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}]","[{'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0455498', 'cui_str': 'H/O: psychiatric disorder'}]",887.0,0.408247,"There was no statistically significant change in adjusted mean (SE) MoCA total score from baseline to EoT in the mirabegron group (-0.2 [0.1]) or the placebo group (-0.1 [0.1]).
","[{'ForeName': 'Tomas L', 'Initials': 'TL', 'LastName': 'Griebling', 'Affiliation': 'Department of Urology and The Landon Center on Aging, University of Kansas School of Medicine, Kansas City, KS, USA. tgriebling@kumc.edu.'}, {'ForeName': 'Noll L', 'Initials': 'NL', 'LastName': 'Campbell', 'Affiliation': 'College of Pharmacy, Purdue University, Lafayette, IN, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Mangel', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, MetroHealth Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': ""Division of Urology, St Elizabeth's Medical Center, Boston, MA, USA.""}, {'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Herschorn', 'Affiliation': 'Division of Urology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Elsouda', 'Affiliation': 'Medical Affairs, Astellas Pharma Global Development, Inc., Northbrook, IL, USA.'}, {'ForeName': 'Carol R', 'Initials': 'CR', 'LastName': 'Schermer', 'Affiliation': 'Medical Affairs, Astellas Pharma Global Development, Inc., Northbrook, IL, USA.'}]",BMC geriatrics,['10.1186/s12877-020-1474-7']
3359,32199738,The oral health quality of life for seniors in residential facilities who have direct access to care as compared to those without access.,"INTRODUCTION
This pilot study tests whether there is a perceived difference in oral health when residents in long-term care facilities receive direct access to the scaling of teeth/debridement using dental hygiene instruments compared to facilities who provide only minimal oral hygiene care.
METHODS
The study was a quasi-experimental pretest/post-test control group design and took place at two long-term care senior residential facilities in Sheridan, Wyoming. Fifteen residents from each facility comprised the study sample (n = 30). The treatment group received a debridement and oral hygiene education and the control group received brushing, flossing, and oral hygiene education.
RESULTS
Results revealed a significant difference in pre/post OHIP-5 scores in the treatment group (p = 0.0222). The control group had improved scores, but it was not significant.
CONCLUSIONS
This study demonstrated a significant difference in the perception of oral health quality of life when seniors received a dental cleaning where they reside.",2020,"The control group had improved scores, but it was not significant.
","['Fifteen residents from each facility comprised the study sample (n\xa0=\xa030', 'seniors in residential facilities']","['debridement and oral hygiene education and the control group received brushing, flossing, and oral hygiene education']","['perception of oral health quality of life', 'pre/post OHIP-5 scores']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}]","[{'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0029162'}, {'cui': 'C0034380'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.029539,"The control group had improved scores, but it was not significant.
","[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Riggs', 'Affiliation': 'Department of Primary Dental Care, School of Dentistry, University of Minnesota, United States. Electronic address: sriggs@umn.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Blue', 'Affiliation': 'Division of Dental Hygiene, School of Dentistry, University of Minnesota, United States.'}, {'ForeName': 'Jennafer', 'Initials': 'J', 'LastName': 'Golden', 'Affiliation': 'Division of Dental Hygiene, School of Dentistry, University of Minnesota, United States.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2019.12.004']
3360,30745567,Postoperative vacuum therapy following AMS™ LGX 700® inflatable penile prosthesis placement: penile dimension outcomes and overall satisfaction.,"Penile shortening after inflatable penile prosthesis for erectile dysfunction is a common postoperative patient complaint and can reduce overall satisfaction with the procedure. In this prospective study we report our results regarding penile dimensions and patient satisfaction outcomes after 1 year of follow-up from AMS™LGX700® penile prosthesis implant with 6 months of vacuum erectile device therapy. Seventy-four selected patients with medically refractory erectile dysfunction underwent AMS™ LGX 700® IPP placement. Postoperatively, patients were assigned vacuum device therapy for 5 min twice daily. Follow-up continued for 1 year after surgery. Dimensional and functional results were assessed. Baseline median preoperative stretched penile length and girth were 14 cm (range 10-17) and 9 cm (range 7-12), respectively. At the end of the study penile median dimensional outcomes were 17 cm (range 13-23) for length and 11 cm (range 10-13) for girth while a median number of 24 pumps (range 18-29) to fully inflate the device was seen. Baseline median International Index of Erectile Function (IIEF-5) score was 9 (range 5-11), at 6 months 20 (range 18-26) and at 1 year was 25 (range 20-27) (p < 0.0001). Median Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) score at the end of the follow-up was 74 (range 66-78). Our postoperative rehabilitation program is feasible and should be recommended after prothesis surgery in order to increase overall satisfaction with the procedure. Penile postoperative dimensional outcomes were statistically significant improved and complications were negligible.",2020,Penile shortening after inflatable penile prosthesis for erectile dysfunction is a common postoperative patient complaint and can reduce overall satisfaction with the procedure.,['Seventy-four selected patients with medically refractory erectile dysfunction underwent AMS™ LGX 700® IPP placement'],"['vacuum device therapy', 'Penile shortening after inflatable penile prosthesis', 'vacuum erectile device therapy']","['Median Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) score', 'Penile postoperative dimensional outcomes', 'Baseline median International Index of Erectile Function (IIEF-5) score']","[{'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0063506', 'cui_str': 'IPP'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C1504335', 'cui_str': 'Device therapy'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0182504', 'cui_str': 'Inflatable penile prosthesis (physical object)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}]",74.0,0.114982,Penile shortening after inflatable penile prosthesis for erectile dysfunction is a common postoperative patient complaint and can reduce overall satisfaction with the procedure.,"[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Antonini', 'Affiliation': 'Department of Urology, Sapienza Rome University, Policlinico Umberto I, Viale del Policlinico 155, Rome, 00161, Italy. gabrieleantoninimd@gmail.com.'}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'De Berardinis', 'Affiliation': 'Department of Urology, Sapienza Rome University, Policlinico Umberto I, Viale del Policlinico 155, Rome, 00161, Italy.'}, {'ForeName': 'Gian Maria', 'Initials': 'GM', 'LastName': 'Busetto', 'Affiliation': 'Department of Urology, Sapienza Rome University, Policlinico Umberto I, Viale del Policlinico 155, Rome, 00161, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Del Giudice', 'Affiliation': 'Department of Urology, Sapienza Rome University, Policlinico Umberto I, Viale del Policlinico 155, Rome, 00161, Italy.'}, {'ForeName': 'Benjamin I', 'Initials': 'BI', 'LastName': 'Chung', 'Affiliation': 'Biostatistical Unit, IRCSS, Regina Elena National Cancer Institute, Via Elio Chianesi, 53, 00144, Roma, Italy.'}, {'ForeName': 'Simon L', 'Initials': 'SL', 'LastName': 'Conti', 'Affiliation': 'Department of Urology, Stanford University Medical Center, 300 Pasteur Dr, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Ferro', 'Affiliation': 'Division of Urology, European Institute of Oncology, Via Giuseppe Ripamonti, 435, 20141, Milan, Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Musi', 'Affiliation': 'Division of Urology, European Institute of Oncology, Via Giuseppe Ripamonti, 435, 20141, Milan, Italy.'}, {'ForeName': 'Ramiro', 'Initials': 'R', 'LastName': 'Fragas', 'Affiliation': 'Clinica Central Cira Garcia, Ave. Lazaro e/ 18y 20, Pya, La, Cárdenas, La Habana, Cuba.'}, {'ForeName': 'Ottavio', 'Initials': 'O', 'LastName': 'De Cobelli', 'Affiliation': 'Division of Urology, European Institute of Oncology, Via Giuseppe Ripamonti, 435, 20141, Milan, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Sperduti', 'Affiliation': 'Biostatistical Unit, IRCSS, Regina Elena National Cancer Institute, Via Elio Chianesi, 53, 00144, Roma, Italy.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Gross', 'Affiliation': 'Section of Urology, Dartmouth-Hitchcock Medical Center, 1 Medical Center Dr, Lebanon, NH, 03766, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Perito', 'Affiliation': 'Department of Urology, Coral Gables Hospital, 3100 Douglas Rd, Coral Gables, FL, 33134, USA.'}]",International journal of impotence research,['10.1038/s41443-019-0125-z']
3361,32183736,Study protocol of a multicenter phase III randomized controlled trial investigating the efficiency of the combination of neoadjuvant chemotherapy (NAC) and neoadjuvant laparoscopic intraperitoneal hyperthermic chemotherapy (NLHIPEC) followed by R0 gastrectomy with intraoperative HIPEC for advanced gastric cancer (AGC): dragon II trial.,"BACKGROUND
Even though treatment modalities such as adjuvant systemic radio-chemotherapy and neoadjuvant chemotherapy (NAC) have individually have improved overall survival (OS) and progression-free survival (PFS) rates in advanced Gastric Cancer (AGC), the peritoneum still presides as a common site of treatment failure and disease recurrence. The role of hyperthermic intraperitoneal chemotherapy (HIPEC) has been acknowledged as prophylaxis for peritoneal carcinomatosis (PC) in AGC patients and in this study, we aim at investigating the safety and efficacy of the combination of neoadjuvant laparoscopic HIPEC (NLHIPEC) with NAC in the neoadjuvant phase followed by surgery of curative intent with intraoperative HIPEC followed by adjuvant chemotherapy (AC).
METHODS
In this multicenter Phase III randomized controlled trial, 326 patients will be randomly separated into 2 groups into a 1:1 ratio after laparoscopic exploration. The experiment arm will receive the proposed comprehensive Dragon II regimen while the control group will undergo standard R0 D2 followed by 8 cycles of AC with oxaliplatin with S-1 (SOX) regimen. The Dragon II regimen comprises of 1 cycle of NLHIPEC for 60mins at 43 ± 0.5 °C with 80 mg/m 2 of Paclitaxel followed by 3 cycles of NAC with SOX regimen and after assessment, standard R0 D2 gastrectomy with intraoperative HIPEC followed by 5 cycles of SOX regimen chemotherapy. The end-points for the study are 5 year PFS, 5 year OS, peritoneal metastasis rate (PMR) and morbidity rate.
DISCUSSION
This study is one of the first to combine NLHIPEC with NAC in the preoperative phase which is speculated to provide local management of occult peritoneal carcinomatosis or peritoneal free cancer cells while NAC will promote tumor downsizing and down-staging. The addition of the intraoperative HIPEC is speculated to manage dissemination due to surgical trauma. Where the roles of intraoperative HIPEC and NAC have individually been investigated, this study provides innovative insight on a more comprehensive approach to management of AGC at high risk of peritoneal recurrence. It is expected that the combination of NLHIPEC with NAC and HIPEC will increase PFS by 15% and decrease PMR after gastrectomy of curative intent.
TRIAL REGISTRATION
World Health Organization Clinical Trials - International Registry Platform (WHO-ICTRP) with Registration ID ChiCTR1900024552, Registered Prospectively on the 16th July, 2019.",2020,"The role of hyperthermic intraperitoneal chemotherapy (HIPEC) has been acknowledged as prophylaxis for peritoneal carcinomatosis (PC) in AGC patients and in this study, we aim at investigating the safety and efficacy of the combination of neoadjuvant laparoscopic HIPEC (NLHIPEC) with NAC in the neoadjuvant phase followed by surgery of curative intent with intraoperative HIPEC followed by adjuvant chemotherapy (AC).
","['peritoneal carcinomatosis (PC) in AGC patients', '326 patients', 'advanced gastric cancer (AGC', 'advanced Gastric Cancer (AGC']","['R0 gastrectomy with intraoperative HIPEC', 'hyperthermic intraperitoneal chemotherapy (HIPEC', 'neoadjuvant chemotherapy (NAC) and neoadjuvant laparoscopic intraperitoneal hyperthermic chemotherapy (NLHIPEC', 'oxaliplatin with S-1 (SOX) regimen', 'neoadjuvant laparoscopic HIPEC (NLHIPEC) with NAC', 'adjuvant systemic radio-chemotherapy and neoadjuvant chemotherapy (NAC', 'Paclitaxel', 'standard R0 D2 gastrectomy with intraoperative HIPEC']","['PMR', 'peritoneal metastasis rate (PMR) and morbidity rate', 'PFS', 'overall survival (OS) and progression-free survival (PFS) rates']","[{'cui': 'C4318618', 'cui_str': 'Peritoneal Surface Malignancy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}]","[{'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0346989', 'cui_str': 'Secondary malignant peritoneal deposit'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",326.0,0.194596,"The role of hyperthermic intraperitoneal chemotherapy (HIPEC) has been acknowledged as prophylaxis for peritoneal carcinomatosis (PC) in AGC patients and in this study, we aim at investigating the safety and efficacy of the combination of neoadjuvant laparoscopic HIPEC (NLHIPEC) with NAC in the neoadjuvant phase followed by surgery of curative intent with intraoperative HIPEC followed by adjuvant chemotherapy (AC).
","[{'ForeName': 'Maneesh Kumarsing', 'Initials': 'MK', 'LastName': 'Beeharry', 'Affiliation': 'Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Department of Surgery, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Zhen-Tian', 'Initials': 'ZT', 'LastName': 'Ni', 'Affiliation': 'Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Department of Surgery, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Zhong Yin', 'Initials': 'ZY', 'LastName': 'Yang', 'Affiliation': 'Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Department of Surgery, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Ya Nan', 'Initials': 'YN', 'LastName': 'Zheng', 'Affiliation': 'Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Department of Surgery, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Run Hua', 'Initials': 'RH', 'LastName': 'Feng', 'Affiliation': 'Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Department of Surgery, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Wen-Tao', 'Initials': 'WT', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Department of Surgery, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China. wt_mygod@163.com.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Department of Surgery, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Xue Xin', 'Initials': 'XX', 'LastName': 'Yao', 'Affiliation': 'Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Department of Surgery, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Department of Surgery, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': 'Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Department of Surgery, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Zheng-Gang', 'Initials': 'ZG', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Department of Surgery, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China. zzg1954@hotmail.com.'}]",BMC cancer,['10.1186/s12885-020-6701-2']
3362,32183768,"A multi-centre, parallel-group, randomised controlled trial to assess the efficacy and safety of eurythmy therapy and tai chi in comparison with standard care in chronically ill elderly patients with increased risk of falling (ENTAiER): a trial protocol.","BACKGROUND
In elderly poeple, multimorbidity and polypharmacy increase while sensory, motor and cognitive functions decrease. Falls occur in 30% of people aged 65 years and older at least once per year, with injuries at 10-20%. Reducing falls and enhancing physical, emotional and cognitive capacities are essential for healthy aging despite chronic disease. Eurythmy therapy (EYT) and Tai Chi train balance, mobility and concentrative and sensory capacities.
METHODS
In eight trial sites (academic or community hospitals), 550 outpatients aged 65 years and older with chronic disease and increased risk of falling (history of imbalance, Berg Balance Scale (BBS) score ≤ 49) will be randomly assigned (1:1:1) to receive either EYT or Tai Chi (each provided in one-hour group sessions, twice, later once per week plus practice at home, for over 24 weeks) added to standard care or standard care alone. Standard care includes a detailed written recommendation on fall prevention and the visit of a primary care doctor. Seniors living a reclusive life or economically disadvantaged elderly will be particularly addressed. A motivation and communication concept supports the trial participants' compliance with trial procedures and practicing. Public and patient representatives are involved in the planning and conduction of the trial. Falls will be documented daily in a diary by the participants. These falls as well as injuries and complications will be ascertained during monthly phone visits. The falls efficacy scale, BBS, cognition (MoCA), Mood (GDS-15), quality of life (SF12), instrumental activities of daily living (IADL), use of medical and non-medical services (FIMA) and adherence will be assessed at months 3, 6, and 12 and inner correspondence with practices (ICPH) at month 6. The trial is funded by the Federal Ministry of Education and Research (BMBF 01GL1805).
DISCUSSION
This study will determine whether EYT and Tai Chi reduce falls, injurious falls, fear of falling and healthcare utilisation and improve mobility, cognition, mood, quality of life and functional independence. A reduction of fall risk and fear of falling and an improvement of mobility, autonomy, quality of life, mood, and cognition are highly relevant for older people to cope with aging and diseases and to reduce healthcare costs. TRAIL REGISTRATION: www.drks.de. DRKS00016609. Registered 30th July 2019.",2020,"A reduction of fall risk and fear of falling and an improvement of mobility, autonomy, quality of life, mood, and cognition are highly relevant for older people to cope with aging and diseases and to reduce healthcare costs.","['healthy aging despite chronic disease', 'chronically ill elderly patients with increased risk of falling (ENTAiER', 'Seniors living a reclusive life or economically disadvantaged elderly', '550 outpatients aged 65\u2009years and older with chronic disease and increased risk of falling (history of imbalance, Berg Balance Scale (BBS) score\u2009≤\u200949']","['eurythmy therapy and tai chi in comparison with standard care', 'EYT or Tai Chi (each provided in one-hour group sessions, twice, later once per week plus practice at home, for over 24\u2009weeks) added to standard care or standard care alone']","['falls efficacy scale, BBS, cognition (MoCA), Mood (GDS-15), quality of life (SF12), instrumental activities of daily living (IADL), use of medical and non-medical services (FIMA) and adherence will be assessed at months 3, 6, and 12 and inner correspondence with practices (ICPH', 'efficacy and safety', 'Eurythmy therapy (EYT) and Tai Chi train balance, mobility and concentrative and sensory capacities', 'Tai Chi reduce falls, injurious falls, fear of falling and healthcare utilisation and improve mobility, cognition, mood, quality of life and functional independence', 'fall risk and fear of falling and an improvement of mobility, autonomy, quality of life, mood, and cognition', 'Reducing falls and enhancing physical, emotional and cognitive capacities']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0008715', 'cui_str': 'Chronically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0222045'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034380'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0199168', 'cui_str': 'Medical service (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",550.0,0.0498911,"A reduction of fall risk and fear of falling and an improvement of mobility, autonomy, quality of life, mood, and cognition are highly relevant for older people to cope with aging and diseases and to reduce healthcare costs.","[{'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Kienle', 'Affiliation': 'Center for Complementary Medicine; Institute for Infection Prevention and Hospital Epidemiology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. gunver.kienle@uniklinik-freiburg.de.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Werthmann', 'Affiliation': 'Center for Complementary Medicine; Institute for Infection Prevention and Hospital Epidemiology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Grotejohann', 'Affiliation': 'Clinical Trials Unit, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kaier', 'Affiliation': 'Institute of Medical Biometry and Statistics, Division Methods in Clinical Epidemiology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Steinbrenner', 'Affiliation': 'Clinical Trials Unit, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Voigt-Radloff', 'Affiliation': 'Center for Geriatric Medicine and Gerontology Freiburg, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Huber', 'Affiliation': 'Center for Complementary Medicine; Institute for Infection Prevention and Hospital Epidemiology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}]",BMC geriatrics,['10.1186/s12877-020-1503-6']
3363,32143674,Adaptive conjunctive cognitive training (ACCT) in virtual reality for chronic stroke patients: a randomized controlled pilot trial.,"BACKGROUND
Current evidence for the effectiveness of post-stroke cognitive rehabilitation is weak, possibly due to two reasons. First, patients typically express cognitive deficits in several domains. Therapies focusing on specific cognitive deficits might not address their interrelated neurological nature. Second, co-occurring psychological problems are often neglected or not diagnosed, although post-stroke depression is common and related to cognitive deficits. This pilot trial aims to test a rehabilitation program in virtual reality that trains various cognitive domains in conjunction, by adapting to the patient's disability and while investigating the influence of comorbidities.
METHODS
Thirty community-dwelling stroke patients at the chronic stage and suffering from cognitive impairment performed 30 min of daily training for 6 weeks. The experimental group followed, so called, adaptive conjunctive cognitive training (ACCT) using RGS, whereas the control group solved standard cognitive tasks at home for an equivalent amount of time. A comprehensive test battery covering executive function, spatial awareness, attention, and memory as well as independence, depression, and motor impairment was applied at baseline, at 6 weeks and 18-weeks follow-up.
RESULTS
At baseline, 75% of our sample had an impairment in more than one cognitive domain. The experimental group showed improvements in attention ([Formula: see text] (2) = 9.57, p < .01), spatial awareness ([Formula: see text] (2) = 11.23, p < .01) and generalized cognitive functioning ([Formula: see text] (2) = 15.5, p < .001). No significant change was seen in the executive function and memory domain. For the control group, no significant change over time was found. Further, they worsened in their depression level after treatment (T = 45, r = .72, p < .01) but returned to baseline at follow-up. The experimental group displayed a lower level of depression than the control group after treatment (Ws = 81.5, z = - 2.76, r = - .60, p < .01) and (Ws = 92, z = - 2.03, r = - .44, p < .05).
CONCLUSIONS
ACCT positively influences attention and spatial awareness, as well as depressive mood in chronic stroke patients.
TRIAL REGISTRATION
The trial was registered prospectively at ClinicalTrials.gov (NCT02816008) on June 21, 2016.",2020,"The experimental group displayed a lower level of depression than the control group after treatment (Ws = 81.5, z = - 2.76, r = - .60, p < .01) and (Ws = 92, z = - 2.03, r = - .44, p < .05).
","['Thirty community-dwelling stroke patients at the chronic stage and suffering from cognitive impairment performed 30\u2009min of daily training for 6 weeks', 'chronic stroke patients']","['adaptive conjunctive cognitive training (ACCT) using RGS', 'ACCT', 'Adaptive conjunctive cognitive training (ACCT']","['executive function and memory domain', 'level of depression', 'executive function, spatial awareness, attention, and memory as well as independence, depression, and motor impairment', 'generalized cognitive functioning', 'spatial awareness']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0584950', 'cui_str': 'Spatial awareness (observable entity)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.113624,"The experimental group displayed a lower level of depression than the control group after treatment (Ws = 81.5, z = - 2.76, r = - .60, p < .01) and (Ws = 92, z = - 2.03, r = - .44, p < .05).
","[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Maier', 'Affiliation': ""Laboratory of Synthetic, Perceptive, Emotive and Cognitive Systems (SPECS), Institute for Bioengineering of Catalonia (IBEC), The Barcelona Institute of Science and Technology, Av. d'Eduard Maristany 10-14, 08930, Barcelona, Spain.""}, {'ForeName': 'Belén Rubio', 'Initials': 'BR', 'LastName': 'Ballester', 'Affiliation': ""Laboratory of Synthetic, Perceptive, Emotive and Cognitive Systems (SPECS), Institute for Bioengineering of Catalonia (IBEC), The Barcelona Institute of Science and Technology, Av. d'Eduard Maristany 10-14, 08930, Barcelona, Spain.""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Leiva Bañuelos', 'Affiliation': ""Rehabilitation Research Group, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Physical Medicine and Rehabilitation Department Parc de Salut Mar (Hospital del Mar, Hospital de l'Esperança), Barcelona, Spain.""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Duarte Oller', 'Affiliation': ""Rehabilitation Research Group, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Physical Medicine and Rehabilitation Department Parc de Salut Mar (Hospital del Mar, Hospital de l'Esperança), Barcelona, Spain.""}, {'ForeName': 'Paul F M J', 'Initials': 'PFMJ', 'LastName': 'Verschure', 'Affiliation': ""Laboratory of Synthetic, Perceptive, Emotive and Cognitive Systems (SPECS), Institute for Bioengineering of Catalonia (IBEC), The Barcelona Institute of Science and Technology, Av. d'Eduard Maristany 10-14, 08930, Barcelona, Spain. pverschure@ibecbarcelona.eu.""}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-0652-3']
3364,31810865,Biomarker-guided antibiotic stewardship in suspected ventilator-associated pneumonia (VAPrapid2): a randomised controlled trial and process evaluation.,"BACKGROUND
Ventilator-associated pneumonia is the most common intensive care unit (ICU)-acquired infection, yet accurate diagnosis remains difficult, leading to overuse of antibiotics. Low concentrations of IL-1β and IL-8 in bronchoalveolar lavage fluid have been validated as effective markers for exclusion of ventilator-associated pneumonia. The VAPrapid2 trial aimed to determine whether measurement of bronchoalveolar lavage fluid IL-1β and IL-8 could effectively and safely improve antibiotic stewardship in patients with clinically suspected ventilator-associated pneumonia.
METHODS
VAPrapid2 was a multicentre, randomised controlled trial in patients admitted to 24 ICUs from 17 National Health Service hospital trusts across England, Scotland, and Northern Ireland. Patients were screened for eligibility and included if they were 18 years or older, intubated and mechanically ventilated for at least 48 h, and had suspected ventilator-associated pneumonia. Patients were randomly assigned (1:1) to biomarker-guided recommendation on antibiotics (intervention group) or routine use of antibiotics (control group) using a web-based randomisation service hosted by Newcastle Clinical Trials Unit. Patients were randomised using randomly permuted blocks of size four and six and stratified by site, with allocation concealment. Clinicians were masked to patient assignment for an initial period until biomarker results were reported. Bronchoalveolar lavage was done in all patients, with concentrations of IL-1β and IL-8 rapidly determined in bronchoalveolar lavage fluid from patients randomised to the biomarker-based antibiotic recommendation group. If concentrations were below a previously validated cutoff, clinicians were advised that ventilator-associated pneumonia was unlikely and to consider discontinuing antibiotics. Patients in the routine use of antibiotics group received antibiotics according to usual practice at sites. Microbiology was done on bronchoalveolar lavage fluid from all patients and ventilator-associated pneumonia was confirmed by at least 10 4 colony forming units per mL of bronchoalveolar lavage fluid. The primary outcome was the distribution of antibiotic-free days in the 7 days following bronchoalveolar lavage. Data were analysed on an intention-to-treat basis, with an additional per-protocol analysis that excluded patients randomly assigned to the intervention group who defaulted to routine use of antibiotics because of failure to return an adequate biomarker result. An embedded process evaluation assessed factors influencing trial adoption, recruitment, and decision making. This study is registered with ISRCTN, ISRCTN65937227, and ClinicalTrials.gov, NCT01972425.
FINDINGS
Between Nov 6, 2013, and Sept 13, 2016, 360 patients were screened for inclusion in the study. 146 patients were ineligible, leaving 214 who were recruited to the study. Four patients were excluded before randomisation, meaning that 210 patients were randomly assigned to biomarker-guided recommendation on antibiotics (n=104) or routine use of antibiotics (n=106). One patient in the biomarker-guided recommendation group was withdrawn by the clinical team before bronchoscopy and so was excluded from the intention-to-treat analysis. We found no significant difference in the primary outcome of the distribution of antibiotic-free days in the 7 days following bronchoalveolar lavage in the intention-to-treat analysis (p=0·58). Bronchoalveolar lavage was associated with a small and transient increase in oxygen requirements. Established prescribing practices, reluctance for bronchoalveolar lavage, and dependence on a chain of trial-related procedures emerged as factors that impaired trial processes.
INTERPRETATION
Antibiotic use remains high in patients with suspected ventilator-associated pneumonia. Antibiotic stewardship was not improved by a rapid, highly sensitive rule-out test. Prescribing culture, rather than poor test performance, might explain this absence of effect.
FUNDING
UK Department of Health and the Wellcome Trust.",2020,We found no significant difference in the primary outcome of the distribution of antibiotic-free days in the 7 days following bronchoalveolar lavage in the intention-to-treat analysis (p=0·58).,"['patients admitted to 24 ICUs from 17 National Health Service hospital trusts across England, Scotland, and Northern Ireland', 'patients with suspected ventilator-associated pneumonia', 'Patients were screened for eligibility and included if they were 18 years or older, intubated and mechanically ventilated for at least 48 h, and had suspected ventilator-associated pneumonia', 'Between Nov 6, 2013, and Sept 13, 2016, 360 patients were screened for inclusion in the study', 'suspected ventilator-associated pneumonia (VAPrapid2', 'Four patients were excluded before randomisation, meaning that 210 patients', '146 patients were ineligible, leaving 214 who were recruited to the study', 'patients with clinically suspected ventilator-associated pneumonia']","['biomarker-guided recommendation on antibiotics (intervention group) or routine use of antibiotics (control group) using a web-based randomisation service hosted by Newcastle Clinical Trials Unit', 'biomarker-guided recommendation on antibiotics (n=104) or routine use of antibiotics', 'Biomarker-guided antibiotic stewardship']","['oxygen requirements', 'distribution of antibiotic-free days in the 7 days following bronchoalveolar lavage', 'Antibiotic stewardship']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C4505100', 'cui_str': 'Antibiotic Stewardship'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1535502', 'cui_str': 'Lung Lavage'}, {'cui': 'C4505100', 'cui_str': 'Antibiotic Stewardship'}]",146.0,0.342377,We found no significant difference in the primary outcome of the distribution of antibiotic-free days in the 7 days following bronchoalveolar lavage in the intention-to-treat analysis (p=0·58).,"[{'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Hellyer', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""The Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK; Regional Intensive Care Unit, The Royal Hospitals, Belfast, UK.""}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Walsh', 'Affiliation': ""Anaesthesia, Critical Care and Pain Medicine, University of Edinburgh, Queen's Medical Research Institute, Edinburgh, UK; Intensive Care Unit, Royal Infirmary of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Anderson', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Conway Morris', 'Affiliation': ""Division of Anaesthesia, Department of Medicine, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Suveer', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Cancer and Surgery, Imperial College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dark', 'Affiliation': 'Division of Infection Immunity and Respiratory Medicine, Manchester National Institute for Health Research Biomedical Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Alistair I', 'Initials': 'AI', 'LastName': 'Roy', 'Affiliation': 'Integrated Critical Care Unit, Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK; Intensive Care Unit, Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'McMullan', 'Affiliation': ""The Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Lydia M', 'Initials': 'LM', 'LastName': 'Emerson', 'Affiliation': ""The Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Bronagh', 'Initials': 'B', 'LastName': 'Blackwood', 'Affiliation': ""The Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Wright', 'Affiliation': 'Integrated Critical Care Unit, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.'}, {'ForeName': 'Kallirroi', 'Initials': 'K', 'LastName': 'Kefala', 'Affiliation': 'Intensive Care Unit, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Cecilia M', 'Initials': 'CM', 'LastName': ""O'Kane"", 'Affiliation': ""The Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Simon V', 'Initials': 'SV', 'LastName': 'Baudouin', 'Affiliation': 'Intensive Care Unit, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Paterson', 'Affiliation': 'Intensive Care Unit, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rostron', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle, UK; Integrated Critical Care Unit, Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Agus', 'Affiliation': 'Northern Ireland Clinical Trials Unit, The Royal Hospitals, Belfast, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Bannard-Smith', 'Affiliation': 'Intensive Care Unit, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Robin', 'Affiliation': 'Intensive Care Unit, Countess of Chester NHS Foundation Trust, Chester, UK.'}, {'ForeName': 'Ingeborg D', 'Initials': 'ID', 'LastName': 'Welters', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bassford', 'Affiliation': 'Intensive Care Unit, University Hospital Coventry, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Yates', 'Affiliation': 'Intensive Care Unit, Northumbria Specialist Emergency Care Hospital, Cramlington, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Spencer', 'Affiliation': 'Intensive Care Unit, Preston Royal Hospital, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'Shondipon K', 'Initials': 'SK', 'LastName': 'Laha', 'Affiliation': 'Intensive Care Unit, Preston Royal Hospital, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hulme', 'Affiliation': 'Intensive Care Unit, Sandwell General Hospital, Sandwell and West Birmingham Hospitals NHS Trust, West Bromwich, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bonner', 'Affiliation': 'Intensive Care Unit, James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Linnett', 'Affiliation': 'Intensive Care Unit, Queen Elizabeth Hospital, Gateshead NHS Foundation Trust, Gateshead, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Sonksen', 'Affiliation': 'Intensive Care Unit, Russells Hall Hospital, Dudley Group NHS Foundation Trust, Dudley, UK.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Van Den Broeck', 'Affiliation': 'Becton Dickinson Biosciences Europe, Erembodegem, Belgium.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Boschman', 'Affiliation': 'Becton Dickinson Biosciences Europe, Erembodegem, Belgium.'}, {'ForeName': 'Dw James', 'Initials': 'DJ', 'LastName': 'Keenan', 'Affiliation': 'Becton Dickinson Biosciences Europe, Erembodegem, Belgium.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scott', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'A Joy', 'Initials': 'AJ', 'LastName': 'Allen', 'Affiliation': 'National Institute for Health Research Newcastle In Vitro Diagnostics Cooperative, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Phair', 'Affiliation': 'Northern Ireland Clinical Trials Unit, The Royal Hospitals, Belfast, UK.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Bowett', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Simpson', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle, UK; National Institute for Health Research Newcastle In Vitro Diagnostics Cooperative, Newcastle University, Newcastle, UK. Electronic address: j.simpson@ncl.ac.uk.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30367-4']
3365,31978933,"Detection of acute 3,4-methylenedioxymethamphetamine (MDMA) effects across protocols using automated natural language processing.","The detection of changes in mental states such as those caused by psychoactive drugs relies on clinical assessments that are inherently subjective. Automated speech analysis may represent a novel method to detect objective markers, which could help improve the characterization of these mental states. In this study, we employed computer-extracted speech features from multiple domains (acoustic, semantic, and psycholinguistic) to assess mental states after controlled administration of 3,4-methylenedioxymethamphetamine (MDMA) and intranasal oxytocin. The training/validation set comprised within-participants data from 31 healthy adults who, over four sessions, were administered MDMA (0.75, 1.5 mg/kg), oxytocin (20 IU), and placebo in randomized, double-blind fashion. Participants completed two 5-min speech tasks during peak drug effects. Analyses included group-level comparisons of drug conditions and estimation of classification at the individual level within this dataset and on two independent datasets. Promising classification results were obtained to detect drug conditions, achieving cross-validated accuracies of up to 87% in training/validation and 92% in the independent datasets, suggesting that the detected patterns of speech variability are associated with drug consumption. Specifically, we found that oxytocin seems to be mostly driven by changes in emotion and prosody, which are mainly captured by acoustic features. In contrast, mental states driven by MDMA consumption appear to manifest in multiple domains of speech. Furthermore, we find that the experimental task has an effect on the speech response within these mental states, which can be attributed to presence or absence of an interaction with another individual. These results represent a proof-of-concept application of the potential of speech to provide an objective measurement of mental states elicited during intoxication.",2020,These results represent a proof-of-concept application of the potential of speech to provide an objective measurement of mental states elicited during intoxication.,"['31 healthy adults who, over four sessions, were administered']","['placebo', 'MDMA', '3,4-methylenedioxymethamphetamine (MDMA) and intranasal oxytocin', 'oxytocin']",[],"[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",[],31.0,0.130727,These results represent a proof-of-concept application of the potential of speech to provide an objective measurement of mental states elicited during intoxication.,"[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Agurto', 'Affiliation': 'Computational Biology Center - Neuroscience, IBM T.J. Watson Research Center, Yorktown Heights, NY, USA.'}, {'ForeName': 'Guillermo A', 'Initials': 'GA', 'LastName': 'Cecchi', 'Affiliation': 'Computational Biology Center - Neuroscience, IBM T.J. Watson Research Center, Yorktown Heights, NY, USA. gcecchi@us.ibm.com.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Norel', 'Affiliation': 'Computational Biology Center - Neuroscience, IBM T.J. Watson Research Center, Yorktown Heights, NY, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ostrand', 'Affiliation': 'Computational Biology Center - Neuroscience, IBM T.J. Watson Research Center, Yorktown Heights, NY, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Baggott', 'Affiliation': 'Addiction and Pharmacology Research Laboratory, Friends Research Institute, San Francisco, CA, USA.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Wardle', 'Affiliation': 'Department of Psychology, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet de', 'Initials': 'H', 'LastName': 'Wit', 'Affiliation': 'Human Behavioral Pharmacology Laboratory, Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Gillinder', 'Initials': 'G', 'LastName': 'Bedi', 'Affiliation': 'Centre for Youth Mental Health, University of Melbourne, and Orygen National Centre of Excellence in Youth Mental Health, Melbourne, Australia.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0620-4']
3366,32176006,"Evaluating the Effect of Infraorbital Region Taping Procedure on Patient Anxiety, Satisfaction, Edema, and Ecchymosis Level on Primary Septorhinoplasty.","AIM
This study aims to evaluate the effect of infraorbital region taping on patients' postoperative edema and ecchymosis, satisfaction levels, and anxiety during follow-up.
METHODS
A total of 64 patients who underwent septorhinoplasty were included in this randomized controlled prospective study. According to the randomization list, the taping group's (TG) infraorbital region was taped with adhesive strips. Others were included in the control group and were classified as the nontaping group. Two blinded physicians evaluated the degree of edema and ecchymosis according to the photographs of patients taken on the first, second, fifth, and seventh postoperative days. Patient's appearance satisfaction was evaluated for ecchymosis levels. State anxiety inventory (STAI-S) and trait anxiety inventory (STAI-T) were used to measure preoperative and postoperative anxiety levels of patients.
RESULTS
The degree of ecchymosis and edema were not significantly different except on the first day in the TG (P = 0.01, P = 0.01, respectively). Significant increment was found in the TG on first, second, and fifth days based on the satisfaction levels of patients for their appearance (P = 0.05, P = 0.03, P = 0.04, respectively). Preoperative STAI-S and STAI-T were similar for the groups (P = 0.78, P = 0.17, respectively). However, postoperative STAI-S of the TG were significantly lower compared with those of the nontaping group except seventh day (P < 0.05).
CONCLUSION
Infraorbital taping did not decrease the edema and ecchymosis except on the first postoperative day. However, it had a significant ameliorating effect on patients' anxiety and satisfaction levels.",2020,"Preoperative STAI-S and STAI-T were similar for the groups (P = 0.78, P = 0.17, respectively).",['64 patients who underwent septorhinoplasty'],"['Infraorbital Region Taping Procedure', 'infraorbital region taping']","['edema and ecchymosis', 'postoperative STAI-S of the TG', 'degree of edema and ecchymosis', 'Preoperative STAI-S and STAI-T', 'degree of ecchymosis and edema', 'satisfaction levels', ""patients' anxiety and satisfaction levels"", 'State anxiety inventory (STAI-S) and trait anxiety inventory (STAI-T', 'Patient Anxiety, Satisfaction, Edema, and Ecchymosis Level', ""patients' postoperative edema and ecchymosis, satisfaction levels, and anxiety""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0189054', 'cui_str': 'Rhinoseptoplasty (procedure)'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",64.0,0.0200119,"Preoperative STAI-S and STAI-T were similar for the groups (P = 0.78, P = 0.17, respectively).","[{'ForeName': 'Kamil Gokce', 'Initials': 'KG', 'LastName': 'Tulaci', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Tulaci', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir.'}, {'ForeName': 'Eren', 'Initials': 'E', 'LastName': 'Tastan', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Ankara Training Research and Referral Hospital, Ulucanlar Caddesi Altindag, Ankara, Turkey.'}, {'ForeName': 'Hasmet', 'Initials': 'H', 'LastName': 'Yazici', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006292']
3367,31869451,"A single-institution, randomized, pilot study evaluating the efficacy of gabapentin and methadone for patients undergoing chemoradiation for head and neck squamous cell cancer.","BACKGROUND
The objective of the current study was to compare the safety and efficacy between 2 analgesic regimens for patients with head and neck cancer (HNC) undergoing definitive chemoradiation (CRT).
METHODS
The current study was a prospective, single-institution, 2-arm, randomized pilot study. Patients with American Joint Committee on Cancer seventh edition stage II to stage IV squamous cell carcinoma of the head and neck who were undergoing CRT were randomized to either arm 1, which entailed high-dose gabapentin (2700 mg daily) with the institutional standard of care (hydrocodone and/or acetaminophen progressing to fentanyl as needed), or arm 2, which comprised low-dose gabapentin (900 mg daily) with methadone. The primary endpoints were safety and toxicity. Secondary endpoints were pain, opioid requirement, and quality of life (QOL). Differences between the treatment arms at multiple time points were compared using a generalized linear mixed regression model with Sidak correction.
RESULTS
A total of 60 patients (31 in arm 1 and 29 in arm 2) were enrolled from April 2015 to August 2017. There was no difference between the treatment arms with regard to adverse events or serious adverse events. Pain was not found to be different between the treatment arms. More patients in arm 1 did not require an opioid during treatment (42% vs 7%; P = .002). Patients in arm 2 experienced significantly better QOL outcomes across multiple domains, including overall health (P = .05), physical functioning (P = .04), role functioning (P = .01), and social functioning (P = .01).
CONCLUSIONS
High-dose prophylactic gabapentin increased the percentage of patients who required no opioid during treatment. Methadone may improve QOL compared with a regimen of short-acting opioids and fentanyl. However, pain was found to significantly worsen throughout treatment regardless of treatment arm, necessitating further studies to identify a more optimal regimen.",2020,"Patients in arm 2 experienced significantly better QOL outcomes across multiple domains, including overall health (P = .05), physical functioning (P = .04), role functioning (P = .01), and social functioning (P = .01).
","['patients undergoing chemoradiation for head and neck squamous cell cancer', '60 patients (31 in arm 1 and 29 in arm 2) were enrolled from April 2015 to August 2017', 'patients with head and neck cancer (HNC) undergoing definitive chemoradiation (CRT', 'Patients with American Joint Committee on Cancer seventh edition stage II to stage IV squamous cell carcinoma of the head and neck who were undergoing CRT']","['acetaminophen', 'gabapentin', 'institutional standard of care (hydrocodone', 'gabapentin and methadone', 'methadone', 'Methadone']","['QOL', 'Pain', 'safety and toxicity', 'physical functioning', 'adverse events or serious adverse events', 'pain, opioid requirement, and quality of life (QOL', 'QOL outcomes', 'social functioning', 'safety and efficacy', 'overall health', 'pain', 'role functioning']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0751688', 'cui_str': 'Squamous Cell Cancer'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0205441', 'cui_str': 'Seventh (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0020264', 'cui_str': 'Hydrocodone'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035820', 'cui_str': 'Role'}]",,0.0778271,"Patients in arm 2 experienced significantly better QOL outcomes across multiple domains, including overall health (P = .05), physical functioning (P = .04), role functioning (P = .01), and social functioning (P = .01).
","[{'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Hermann', 'Affiliation': 'Department of Radiation Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Austin J', 'Initials': 'AJ', 'LastName': 'Iovoli', 'Affiliation': 'Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Alexis J', 'Initials': 'AJ', 'LastName': 'Platek', 'Affiliation': 'Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'Department of Biostatistics, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Kristopher', 'Initials': 'K', 'LastName': 'Attwood', 'Affiliation': 'Department of Biostatistics, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Bourgeois', 'Affiliation': 'Department of Radiation Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Anurag K', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Department of Radiation Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}]",Cancer,['10.1002/cncr.32676']
3368,32071149,Randomised clinical trial to determine the safety of quercetin supplementation in patients with chronic obstructive pulmonary disease.,"INTRODUCTION
Quercetin is a plant flavonoid and has potent antioxidant and anti-inflammatory properties. In a preclinical model of chronic obstructive pulmonary disease (COPD), quercetin reduced markers of both oxidative stress and lung inflammation and also reduced rhinovirus-induced progression of lung disease. Although quercetin appears to be an attractive natural alternative to manage COPD, the safety of quercetin supplementation in this population is unknown.
METHODS
We recruited COPD patients with mild-to-severe lung disease with FVE1 ranging between >35% and <80% and supplemented with either placebo or quercetin at 500, 1000 or 2000 mg/day in a dose-escalation manner. The duration of quercetin supplementation was 1 week.
RESULTS
Patients had no study drug-related severe adverse events based on blood tests, which included both complete blood counts and evaluation of comprehensive metabolic panel. One of the patients reported mild adverse events included gastro-oesophageal reflux disease, which was observed in both placebo and quercetin groups.
CONCLUSIONS
Quercetin was safely tolerated up to 2000 mg/day as assessed by lung function, blood profile and COPD assessment test questionnaire.
TRIAL REGISTRATION NUMBER
NCT01708278.",2020,"In a preclinical model of chronic obstructive pulmonary disease (COPD), quercetin reduced markers of both oxidative stress and lung inflammation and also reduced rhinovirus-induced progression of lung disease.","['COPD patients with mild-to-severe lung disease with FVE1 ranging between >35%\u2009and <80%\u2009and supplemented with either', 'patients with chronic obstructive pulmonary disease']","['quercetin supplementation', 'placebo or quercetin']","['safely tolerated', 'lung function, blood profile and COPD assessment test questionnaire', 'mild adverse events included gastro-oesophageal reflux disease', 'duration of quercetin supplementation']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0005768'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}]",,0.0939912,"In a preclinical model of chronic obstructive pulmonary disease (COPD), quercetin reduced markers of both oxidative stress and lung inflammation and also reduced rhinovirus-induced progression of lung disease.","[{'ForeName': 'Meilan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Tyler A', 'Initials': 'TA', 'LastName': 'Barreto', 'Affiliation': 'Thoracic Medicine and Surgery, Temple University Medical School, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Medicine, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Comstock', 'Affiliation': 'Pediatrics, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Umadevi S', 'Initials': 'US', 'LastName': 'Sajjan', 'Affiliation': 'Thoracic Medicine and Surgery, Temple University Medical School, Philadelphia, Pennsylvania, USA uma.sajjan@temple.edu.'}]",BMJ open respiratory research,['10.1136/bmjresp-2018-000392']
3369,31999297,Characteristics of Eyes With Good Visual Acuity at 5 Years After Initiation of Treatment for Age-Related Macular Degeneration but Not Receiving Treatment From Years 3 to 5: Post Hoc Analysis of the CATT Randomized Clinical Trial.,"Importance
Identifying the characteristics of eyes with neovascular age-related macular degeneration (nAMD) that maintain good vision without anti-vascular endothelial growth factor treatment for at least 3 years after management, as occurred in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT), may have prognostic importance and help in understanding the disease and its treatment.
Objectives
To ascertain the characteristics of eyes in the CATT that retained good vision despite receiving no therapy for 3 years after release from the 2-year CATT treatment protocol.
Design, Setting and Participants
This case-control study analyzed the baseline and follow-up characteristics of eyes with nAMD that were enrolled in the CATT from 43 US clinical centers between February 20, 2008, and December 9, 2009. After initial randomization to 1 of 4 treatment groups (ranibizumab monthly, bevacizumab monthly, ranibizumab as needed, or bevacizumab as needed), at year 1, participants in the monthly groups were rerandomized to continue monthly treatment or to switch to as-needed treatment using the same drug as originally assigned. At year 2, participants were released from the protocol to treatment at the discretion of their ophthalmologist. At year 5, participants were recalled for examination. This present analysis, conducted from December 1, 2018, to September 30, 2019, compared the eyes of 40 participants (referred to as the cessation of treatment with good visual acuity, or CTGVA, group) with the eyes of the remainder of the CATT Follow-up Study (referred to as the other group).
Main Outcomes and Measures
Visual acuity, morphologic characteristics, and number of treatments over 5 years.
Results
Among 625 eyes with nAMD at baseline and a visual acuity measurement at year 5, 40 (6.4%; 95% CI, 4.7%-8.7%) were included in the analysis. These 40 participants, compared with the other group (n = 585), had a lower mean (SD) age of 74.7 (7.3) years (vs 77.7 [7.3] years; P = .01) and included 26 women (65.0%). Baseline characteristics were similar between eyes in the CTGVA and other groups, except for better visual acuity letter score in the study eye (68.8 vs 61.8; P = .001) and the fellow eye (78.4 vs 68.0; P = .01) as well as the presence of blocked fluorescence seen more often in participants in the CTGVA vs the other group (27.5% vs 13.8%; P = .02). Eyes in the CTGVA group with as-needed treatment received fewer mean (SD) injections in year 1 (5.8 [4.0] vs 8.1 [3.5]) and year 2 (7.7 [5.7] vs 13.8 [6.8]) than eyes in the other as-needed group. Mean (SD) visual acuity letter score at 5 years was 79.0 (5.5; Snellen 20/25) in the CTGVA group and 57.5 (24.2; Snellen 20/80) in the other group.
Conclusions and Relevance
These findings suggest that a small proportion of eyes with nAMD can retain good visual acuity with no treatment for at least 3 years after the initial 2 years of treatment. Unique characteristics of eyes that could discontinue treatment while maintaining good visual acuity could not be identified at baseline, but data suggest that not all eyes with this disease may need treatment forever.
Trial Registration
ClinicalTrials.gov Identifier: NCT00593450.",2020,"Baseline characteristics were similar between eyes in the CTGVA and other groups, except for better visual acuity letter score in the study eye (68.8 vs 61.8; P = .001) and the fellow eye (78.4 vs 68.0; P = .01) as well as the presence of blocked fluorescence seen more often in participants in the CTGVA vs the other group (27.5% vs 13.8%; P = .02).","['625 eyes with nAMD at baseline and a', 'eyes with nAMD that were enrolled in the CATT from 43 US clinical centers between February 20, 2008, and December 9, 2009', 'Eyes With Good Visual Acuity at 5 Years', 'conducted from December 1, 2018, to September 30, 2019, compared the eyes of 40 participants (referred to as the cessation of treatment with good visual acuity, or CTGVA, group) with the eyes of the remainder of the CATT Follow-up Study (referred to as the other group', 'eyes with neovascular age-related macular degeneration (nAMD']","['ranibizumab monthly, bevacizumab monthly, ranibizumab', 'CTGVA']","['visual acuity', 'good visual acuity', 'visual acuity letter score', 'Measures\n\n\nVisual acuity, morphologic characteristics, and number of treatments over 5 years', 'fellow eye', 'visual acuity measurement', 'Mean (SD) visual acuity letter score']","[{'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0871549', 'cui_str': 'Cessation of Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",26.0,0.215636,"Baseline characteristics were similar between eyes in the CTGVA and other groups, except for better visual acuity letter score in the study eye (68.8 vs 61.8; P = .001) and the fellow eye (78.4 vs 68.0; P = .01) as well as the presence of blocked fluorescence seen more often in participants in the CTGVA vs the other group (27.5% vs 13.8%; P = .02).","[{'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Scoles', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Gui-Shuang', 'Initials': 'GS', 'LastName': 'Ying', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Peiying', 'Initials': 'P', 'LastName': 'Hua', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'Grunwald', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Ebenezer', 'Initials': 'E', 'LastName': 'Daniel', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Duke Eye Center, Duke University, Durham, North Carolina.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Toth', 'Affiliation': 'Duke Eye Center, Duke University, Durham, North Carolina.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Martin', 'Affiliation': 'Cole Eye Institute, The Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.5831']
3370,32187097,Does Surgical-site Multimodal Drug Injection After Palmar Plating of Distal Radius Fractures Improve Pain Scores?,"BACKGROUND
Although palmar locked plating is a stable fixation method frequently used to treat unstable distal radius fractures (DRFs), surgical treatment may be painful, and so interventions to decrease that pain might improve our patients' experiences with surgery. Some surgeons use local multimodal drug injections to decrease postoperative pain after lower-extremity arthroplasty, but little is known about the effectiveness of a local multimodal drug injection in patients who undergo palmar plating for DRFs.
QUESTIONS/PURPOSES
(1) Do patients who receive a local multimodal drug injection after palmar plating for unstable DRFs have better pain scores at 4, 8, 24, and 48 hours after surgery than patients who have not received such an injection? (2) Do patients who receive a local multimodal drug injection have lower fentanyl consumption and administration of anti-emetic drugs within the first 48 hours after surgery than patients who have not received such an injection?
METHODS
A randomized controlled study was performed between August 2018 and August 2019 at a single tertiary care referral center. Patients who underwent palmar plating for DRFs under general anesthesia were eligible for inclusion. Patients were allocated into two groups: Those who received a local multimodal drug injection, and those who did not receive an injection. During the study period, 101 patients treated with palmar plating for DRFs met the inclusion criteria and were enrolled and randomized. Fifty-two patients were allocated to the multimodal injection group and 49 were allocated to the control group. Three patients (two in the multimodal injection group and one in the control group) were excluded after randomization because their pain level was not registered at any timepoint and so they could not be analyzed; our analysis was by intention to treat, and there was no crossover. After palmar plating, patients in the multimodal injection group received an injection of ropivacaine (10 mL), morphine (5 mL), ceftezole (5 mL) as well as normal saline (5 mL) to the periosteal area, pronator quadratus muscle, subcutaneous area, and skin. There were no differences between the groups in terms of age (62 years ± 13 years in the multimodal injection group versus 62 years ± 11 years in the control group; p = 0.93), gender (84% [42 of 50] women in the multimodal injection group versus 77% [37 of 48] women in the control group; p = 0.39), hand dominance (70% [35 of 50] dominant wrist in the multimodal injection group versus 60% [29 of 48] dominant wrist in the control group; p = 0.32) and AO/Orthopaedic Trauma Association (AO/OTA) classification (p = 0.57). All patients underwent treatment with the same perioperative protocol, and 25 μg of fentanyl was injected intravenously when a patient complained of pain and asked for additional pain control after surgery. In addition, when a patient complained of nausea or vomiting associated with fentanyl use, an anti-emetic drug was also injected. All nursing staff who administered the analgesics and anti-emetic drugs were blinded to treatment allocation. These two groups were compared regarding their pain level using a 100-mm VAS at 4, 8, 24, and 48 hours postoperatively. The minimum clinically important difference (MCID) for the VAS score was set to 20 mm. VAS scores were also collected by nursing staff who remained blinded to the treatment allocation. The total amount of fentanyl use and the number of patients who received anti-emetic drugs associated with administration of fentanyl within the first 48 hours were also recorded.
RESULTS
With an MCID of 20 points, we found no clinically important reduction in VAS scores among patients who received a local multimodal injection compared with those who did not receive an injection at 4 hours (34 ± 15 versus 41 ± 20, mean difference -7.079 [95% CI -13.986 to -0.173]; p = 0.045), 8 hours (27 ± 16 versus 40 ± 19, mean difference -12.263 [95% CI -19.174 to -5.353]; p = 0.001), 24 hours (18 ± 12 versus 29 ± 20, mean difference -11.042 [95% CI -17.664 to -4.419]; p = 0.001), and 48 hours (9 ± 8 versus 10 ± 6, mean difference -1.318 [95% CI -4.000 to 1.365]; p = 0.33). Within the first 48 hours after surgery, fentanyl consumption was lower in patients receiving a local multimodal injection than in control patients (25 μg [range 0-100 μg] versus 37.5 μg [range 0-125 μg], difference of medians -12.5; p = 0.01). There was also a difference between the study groups in terms of the proportion of patients who received anti-emetic medications (16% [8 of 50] in the multimodal injection group versus 35% [17 of 48] in the control group, odds ratio = 2.879 [95% CI 1.102 to 7.519]; p = 0.03).
CONCLUSIONS
Our data suggest that patients who received a surgical-site multimodal analgesic injection after palmar plating for a distal radius fracture had no clinically important reduction in pain scores, but they did consume lower doses of opioid analgesics and fewer of these patients received anti-emetic drugs within 2 days of surgery. The high-potency opioids or other analgesia usually used for postoperative pain management have many side effects. Thus, reducing additional analgesia is as important as postoperative pain management and a surgical-site multimodal analgesic injection is one of the methods to achieve this a goal.
LEVEL OF EVIDENCE
Level I, therapeutic study.",2020,"Within the first 48 hours after surgery, fentanyl consumption was lower in patients receiving a local multimodal injection than in control patients (25 μg [range 0-100 μg] versus 37.5 μg [range 0-125 μg], difference of medians -12.5; p = 0.01).","['101 patients treated with palmar plating for DRFs met the inclusion criteria and were enrolled and randomized', 'patients who undergo palmar plating for DRFs', 'Distal Radius Fractures', 'Fifty-two patients', 'August 2018 and August 2019 at a single tertiary care referral center', 'Patients who underwent palmar plating for DRFs under general anesthesia were eligible for inclusion']","['fentanyl', 'morphine (5 mL), ceftezole (5 mL) as well as normal saline', 'multimodal injection', 'palmar locked plating', 'ropivacaine', 'local multimodal drug injection, and those who did not receive an injection']","['Pain Scores', 'VAS scores', 'pain scores', 'VAS score', 'fentanyl consumption', 'pain level', 'nausea or vomiting', 'postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1720969', 'cui_str': 'Metacarpophalangeal Volar Plate'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0055013', 'cui_str': 'ceftezol'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1184147', 'cui_str': 'Palmar (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",52.0,0.171431,"Within the first 48 hours after surgery, fentanyl consumption was lower in patients receiving a local multimodal injection than in control patients (25 μg [range 0-100 μg] versus 37.5 μg [range 0-125 μg], difference of medians -12.5; p = 0.01).","[{'ForeName': 'Hyoung-Seok', 'Initials': 'HS', 'LastName': 'Jung', 'Affiliation': 'H.-S. Jung, K.-J. Chun, J. Y. Kim, J. Lee, J. S. Lee, Department of Orthopaedic Surgery, Medical Center of Chung-Ang University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Kwang-Jin', 'Initials': 'KJ', 'LastName': 'Chun', 'Affiliation': ''}, {'ForeName': 'Jae Yoon', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jeongik', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jae Sung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001212']
3371,31712342,Sedation AND Weaning In Children (SANDWICH): protocol for a cluster randomised stepped wedge trial.,"INTRODUCTION
Weaning from ventilation is a complex process involving several stages that include recognition of patient readiness to begin the weaning process, steps to reduce ventilation while optimising sedation in order not to induce distress and removing the endotracheal tube. Delay at any stage can prolong the duration of mechanical ventilation. We developed a multicomponent intervention targeted at helping clinicians to safely expedite this process and minimise the harms associated with unnecessary mechanical ventilation.
METHODS AND ANALYSIS
This is a 20-month cluster randomised stepped wedge clinical and cost-effectiveness trial with an internal pilot and a process evaluation. It is being conducted in 18 paediatric intensive care units in the UK to evaluate a protocol-based intervention for reducing the duration of invasive mechanical ventilation. Following an initial 8-week baseline data collection period in all sites, one site will be randomly chosen to transition to the intervention every 4 weeks and will start an 8-week training period after which it will continue the intervention for the remaining duration of the study. We aim to recruit approximately 10 000 patients. The primary analysis will compare data from before the training (control) with that from after the training (intervention) in each site. Full details of the analyses will be in the statistical analysis plan.
ETHICS AND DISSEMINATION
This protocol was reviewed and approved by NRES Committee East Midlands-Nottingham 1 Research Ethics Committee (reference: 17/EM/0301). All sites started patient recruitment on 5 February 2018 before randomisation in April 2018. Results will be disseminated in 2020. The results will be presented at national and international conferences and published in peer-reviewed medical journals.
TRIAL REGISTRATION NUMBER
ISRCTN16998143.",2019,"We developed a multicomponent intervention targeted at helping clinicians to safely expedite this process and minimise the harms associated with unnecessary mechanical ventilation.
","['recruit approximately 10\u2009000 patients', '18 paediatric intensive care units in the UK']",['Sedation AND Weaning'],['duration of mechanical ventilation'],"[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021710', 'cui_str': 'PICU - Pediatric intensive care unit'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]",18.0,0.137875,"We developed a multicomponent intervention targeted at helping clinicians to safely expedite this process and minimise the harms associated with unnecessary mechanical ventilation.
","[{'ForeName': 'Bronagh', 'Initials': 'B', 'LastName': 'Blackwood', 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK b.blackwood@qub.ac.uk MargaretX.Murray@nictu.hscni.net.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Agus', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Roisin', 'Initials': 'R', 'LastName': 'Boyle', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""Centre for Public Health, Institute of Clinical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Public Health, Epidemiology and Biostatistics, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Macrae', 'Affiliation': 'Paediatric Intensive Care Unit, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Daniel Francis', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Clíona', 'Initials': 'C', 'LastName': 'McDowell', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McIlmurray', 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Morris', 'Affiliation': ""Paediatric Intensive Care Unit, Birmingham Women's and Children's Hospital, Birmingham, UK.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Murray', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK b.blackwood@qub.ac.uk MargaretX.Murray@nictu.hscni.net.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Parslow', 'Affiliation': 'Faculty of Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Peters', 'Affiliation': 'Paediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Trust, London, UK.'}, {'ForeName': 'Lyvonne N', 'Initials': 'LN', 'LastName': 'Tume', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England Bristol, Bristol, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': ""MRC Centre for Inflammation Research, The Queen's Medical Research Institute, The University of Edinburgh, Edinburgh, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-031630']
3372,31917441,Efficacy of a Treat-and-Extend Regimen With Ranibizumab in Patients With Neovascular Age-Related Macular Disease: A Randomized Clinical Trial.,"Importance
Although the Canadian Treat-and-Extend Analysis Trial With Ranibizumab in Patients With Neovascular Age-Related Macular Disease (CANTREAT) reported herein and the Treat and Extend study provided data to show noninferiority of treat-and-extend (T&E) at 12 months, to date there are few data on 24-month T&E trials compared with monthly dosing.
Objective
To compare the efficacy of ranibizumab using a T&E regimen to monthly dosing in treatment-naive patients with neovascular age-related macular degeneration (nAMD) after 24 months.
Design, Setting, and Participants
A randomized, open-label, multicenter, noninferiority intention-to-treat trial with a margin of -5 letters in best-corrected visual acuity (BCVA) from baseline to 12 months between groups was conducted at 27 treatment centers in Canada. Participants included 580 patients with treatment-naive choroidal neovascularization secondary to AMD. The study was conducted from May 8, 2013, to August 28, 2018, and data analysis was performed between August 29 and September 12, 2018.
Interventions
Patients with nAMD were randomized 1:1 to receive intravitreal ranibizumab, 0.5 mg, in either a T&E or monthly dosing regimen.
Main Outcomes and Measures
Mean change in BCVA in Early Treatment of Diabetic Retinopathy Study letters from baseline to month 24.
Results
Of the 580 randomized patients, 350 were women (60.3%) and 547 were white (94.3%). Mean (SD) age was 78.8 (7.8) years. By the end of month 24, 466 of the 580 randomized patients (80.3%) had completed the study and participants in the T&E arm received a mean of 17.6 injections compared with 23.5 injections for the monthly arm, for a difference of 5.9 injections and visits over 2 years (95% CI, 5.4-6.5; P < .001). The mean (SD) BCVA improvement was not worse with the T&E arm, 6.8 (14.1) letters vs 6.0 (12.6) letters, compared with the monthly arm (difference, 0.9; 95% CI, -1.6 to 3.3; P = .21). There was a gain of 15 or more letters in 25.5% of the T&E group and 23.1% of the monthly treatment group (difference, 2.4%; 95% CI, -6.8% to 11.6%; P = .59) and a loss of 15 or more letters in 6.5% of the T&E group and 5.8% of the monthly treatment group (difference, -0.7%; 95% CI, -9.9% to 8.5%; P = .85).
Conclusions and Relevance
These findings suggest that change in vision from baseline is not worse with a T&E compared with a monthly regimen of ranibizumab for nAMD through 24 months, achieving clinically meaningful improvements in BCVA despite fewer injections and visits.
Trial Registration
ClinicalTrials.gov identifier: NCT02103738.",2020,"The mean (SD) BCVA improvement was not worse with the T&E arm, 6.8 (14.1) letters vs 6.0 (12.6) letters, compared with the monthly arm (difference, 0.9; 95% CI, -1.6 to 3.3; P = .21).","['580 randomized patients', 'Participants included 580 patients with treatment-naive choroidal neovascularization secondary to AMD', 'treatment-naive patients with neovascular age-related macular degeneration (nAMD) after 24 months', '350 were women (60.3%) and 547 were white (94.3', 'Mean (SD) age was 78.8 (7.8) years', 'Patients With Neovascular Age-Related Macular Disease (CANTREAT', 'Patients With Neovascular Age-Related Macular Disease', 'Interventions\n\n\nPatients with nAMD', 'May 8, 2013, to August 28, 2018, and data analysis was performed between August 29 and September 12, 2018']","['T&E or monthly dosing regimen', 'ranibizumab', 'Ranibizumab', 'Treat-and-Extend Regimen With Ranibizumab', 'intravitreal ranibizumab']","['gain of 15 or more letters', 'mean (SD) BCVA improvement']","[{'cui': 'C4517818', 'cui_str': 'Five hundred and eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600518', 'cui_str': 'Neovascularization, Choroid'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0730362', 'cui_str': 'Maculopathy'}, {'cui': 'C0010992', 'cui_str': 'Data Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",580.0,0.338271,"The mean (SD) BCVA improvement was not worse with the T&E arm, 6.8 (14.1) letters vs 6.0 (12.6) letters, compared with the monthly arm (difference, 0.9; 95% CI, -1.6 to 3.3; P = .21).","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kertes', 'Affiliation': 'The John and Liz Tory Eye Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Ivan J', 'Initials': 'IJ', 'LastName': 'Galic', 'Affiliation': 'Montreal Retina Institute, Montreal, Québec, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Greve', 'Affiliation': 'Alberta Retina Consultants, Edmonton, Alberta, Canada.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Williams', 'Affiliation': 'Calgary Retina Consultants, Calgary, Alberta, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Novartis Pharmaceuticals Canada Inc, Dorval, Québec, Canada.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Lahaie', 'Affiliation': 'Novartis Pharmaceuticals Canada Inc, Dorval, Québec, Canada.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Sheidow', 'Affiliation': 'Ivey Eye Institute, London, Ontario, Canada.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.5540']
3373,30809700,Remotely programmed sacral neuromodulation for the treatment of patients with refractory overactive bladder: a prospective randomized controlled trial evaluating the safety and efficacy of a novel sacral neuromodulation device.,"PURPOSE
The efficacy and safety of a novel remotely programmed BetterStim sacral neuromodulation (SNM) system was evaluated in patients with refractory overactive bladder (OAB) in a prospective, controlled, multicenter trial.
METHODS
A total of 84 patients referred for SNM therapy from October 2015 to January 2018 were studied. Of the patients who qualified for implantation, 37 and 33 were randomly assigned to treatment and control groups, respectively. Patients in the treatment group underwent stimulation upon implantation, while stimulation was delayed in the control group for 3 months. Follow-up visits, consisting of voiding diary outcome, questionnaires regarding overactive bladder symptom score (OABSS) and quality of life were conducted at 1, 3, and 6-month post-implantation.
RESULTS
Compared with the control group, subjects in the treatment group exhibited statistically significant improvement in OAB symptoms at 3 months. The overall success rate was achieved in 72% of the treatment group, compared with 12% of the control group at 3 months. At 6 months, there were no significant differences in key voiding diary variables between the two groups. Further, this study demonstrated sustained improvement in urinary symptom interference in OAB patients. In addition, nearly all patients expressed great satisfaction with the remote-programming methods. No serious adverse events occurred, and device-related adverse events rate was 12.86%.
CONCLUSION
This clinical study demonstrates subjective and objective success of the BetterStim SNM system. Importantly, our data suggest that remote programming can be safely used as a viable option for the conventional programming with a high degree of patient satisfaction.",2019,"The overall success rate was achieved in 72% of the treatment group, compared with 12% of the control group at 3 months.","['patients with refractory overactive bladder (OAB', 'patients who qualified for implantation, 37 and 33', 'patients with refractory overactive bladder', '84 patients referred for SNM therapy from October 2015 to January 2018 were studied', 'OAB patients']","['Remotely programmed sacral neuromodulation', 'novel remotely programmed BetterStim sacral neuromodulation (SNM) system', 'novel sacral neuromodulation device']","['adverse events rate', 'urinary symptom interference', 'voiding diary outcome, questionnaires regarding overactive bladder symptom score (OABSS) and quality of life', 'key voiding diary variables', 'overall success rate', 'OAB symptoms', 'efficacy and safety', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",84.0,0.0365936,"The overall success rate was achieved in 72% of the treatment group, compared with 12% of the control group at 3 months.","[{'ForeName': 'Yaoguang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Urology Department, Beijing Hospital, National Center of Gerontology, No. 1 DaHua Road, Dong Dan, Beijing, 100730, People's Republic of China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Urology Department, Beijing Chaoyang Hospital, Capital Medical University, Beijing, 100020, People's Republic of China.""}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': ""Urology Department, Peking University Third Hospital, Beijing, 100191, People's Republic of China.""}, {'ForeName': 'Guoqing', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""Urology Department, China Rehabilitation Research Center, Capital Medical University, No. 10 North Road, Fengtai District, Beijing, 100068, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Urology Department, Qilu Hospital, Shandong University, Jinan, Shandong, 250012, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Urology Department, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100050, People's Republic of China.""}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Urology Department, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, People's Republic of China.""}, {'ForeName': 'Zhongqing', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': ""Urology Department, Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210000, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Urology Department, Beijing Hospital, National Center of Gerontology, No. 1 DaHua Road, Dong Dan, Beijing, 100730, People's Republic of China.""}, {'ForeName': 'Lulin', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ""Urology Department, Peking University Third Hospital, Beijing, 100191, People's Republic of China.""}, {'ForeName': 'Benkang', 'Initials': 'B', 'LastName': 'Shi', 'Affiliation': ""Urology Department, Qilu Hospital, Shandong University, Jinan, Shandong, 250012, People's Republic of China.""}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Liao', 'Affiliation': ""Urology Department, China Rehabilitation Research Center, Capital Medical University, No. 10 North Road, Fengtai District, Beijing, 100068, People's Republic of China. lmliao@263.net.""}, {'ForeName': 'Jianye', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Urology Department, Beijing Hospital, National Center of Gerontology, No. 1 DaHua Road, Dong Dan, Beijing, 100730, People's Republic of China. jianye_wangbhp@126.com.""}]",World journal of urology,['10.1007/s00345-019-02698-7']
3374,32044943,"Effect of Vancomycin or Daptomycin With vs Without an Antistaphylococcal β-Lactam on Mortality, Bacteremia, Relapse, or Treatment Failure in Patients With MRSA Bacteremia: A Randomized Clinical Trial.","Importance
Methicillin-resistant Staphylococcus aureus (MRSA) bacteremia is associated with mortality of more than 20%. Combining standard therapy with a β-lactam antibiotic has been associated with reduced mortality, although adequately powered randomized clinical trials of this intervention have not been conducted.
Objective
To determine whether combining an antistaphylococcal β-lactam with standard therapy is more effective than standard therapy alone in patients with MRSA bacteremia.
Design, Setting, and Participants
Open-label, randomized clinical trial conducted at 27 hospital sites in 4 countries from August 2015 to July 2018 among 352 hospitalized adults with MRSA bacteremia. Follow-up was complete on October 23, 2018.
Interventions
Participants were randomized to standard therapy (intravenous vancomycin or daptomycin) plus an antistaphylococcal β-lactam (intravenous flucloxacillin, cloxacillin, or cefazolin) (n = 174) or standard therapy alone (n = 178). Total duration of therapy was determined by treating clinicians and the β-lactam was administered for 7 days.
Main Outcomes and Measures
The primary end point was a 90-day composite of mortality, persistent bacteremia at day 5, microbiological relapse, and microbiological treatment failure. Secondary outcomes included mortality at days 14, 42, and 90; persistent bacteremia at days 2 and 5; acute kidney injury (AKI); microbiological relapse; microbiological treatment failure; and duration of intravenous antibiotics.
Results
The data and safety monitoring board recommended early termination of the study prior to enrollment of 440 patients because of safety. Among 352 patients randomized (mean age, 62.2 [SD, 17.7] years; 121 women [34.4%]), 345 (98%) completed the trial. The primary end point was met by 59 (35%) with combination therapy and 68 (39%) with standard therapy (absolute difference, -4.2%; 95% CI, -14.3% to 6.0%). Seven of 9 prespecified secondary end points showed no significant difference. For the combination therapy vs standard therapy groups, all-cause 90-day mortality occurred in 35 (21%) vs 28 (16%) (difference, 4.5%; 95% CI, -3.7% to 12.7%); persistent bacteremia at day 5 was observed in 19 of 166 (11%) vs 35 of 172 (20%) (difference, -8.9%; 95% CI, -16.6% to -1.2%); and, excluding patients receiving dialysis at baseline, AKI occurred in 34 of 145 (23%) vs 9 of 145 (6%) (difference, 17.2%; 95% CI, 9.3%-25.2%).
Conclusions and Relevance
Among patients with MRSA bacteremia, addition of an antistaphylococcal β-lactam to standard antibiotic therapy with vancomycin or daptomycin did not result in significant improvement in the primary composite end point of mortality, persistent bacteremia, relapse, or treatment failure. Early trial termination for safety concerns and the possibility that the study was underpowered to detect clinically important differences in favor of the intervention should be considered when interpreting the findings.
Trial Registration
ClinicalTrials.gov Identifier: NCT02365493.",2020,Seven of 9 prespecified secondary end points showed no significant difference.,"['Patients With MRSA Bacteremia', 'patients with MRSA bacteremia', '27 hospital sites in 4 countries from August 2015 to July 2018 among 352 hospitalized adults with MRSA bacteremia', '440 patients because of safety', '352 patients randomized (mean age, 62.2 [SD, 17.7] years; 121 women [34.4%]), 345 (98%) completed the trial']","['standard therapy (intravenous vancomycin or daptomycin) plus an antistaphylococcal β-lactam (intravenous flucloxacillin, cloxacillin, or cefazolin) (n\u2009=\u2009174) or standard therapy alone', 'antistaphylococcal β-lactam with standard therapy', 'Vancomycin or Daptomycin', 'vancomycin or daptomycin']","['mortality, persistent bacteremia, relapse, or treatment failure', 'persistent bacteremia', 'mortality at days 14, 42, and 90; persistent bacteremia at days 2 and 5; acute kidney injury (AKI); microbiological relapse; microbiological treatment failure; and duration of intravenous antibiotics', 'Total duration of therapy', '90-day composite of mortality, persistent bacteremia at day 5, microbiological relapse, and microbiological treatment failure', '90-day mortality', 'Mortality, Bacteremia, Relapse, or Treatment Failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4040349', 'cui_str': 'Bacteremia caused by Methicillin resistant Staphylococcus aureus (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0057144', 'cui_str': 'Daptomycin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0022914', 'cui_str': 'Lactams'}, {'cui': 'C0016267', 'cui_str': 'flucloxacillin'}, {'cui': 'C0009077', 'cui_str': 'Cloxacillin'}, {'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0162643'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444917', 'cui_str': 'Duration of therapy (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",352.0,0.317516,Seven of 9 prespecified secondary end points showed no significant difference.,"[{'ForeName': 'Steven Y C', 'Initials': 'SYC', 'LastName': 'Tong', 'Affiliation': 'Victorian Infectious Disease Service, Royal Melbourne Hospital, and University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'National Centre for Infectious Diseases, Singapore.'}, {'ForeName': 'Dafna', 'Initials': 'D', 'LastName': 'Yahav', 'Affiliation': 'Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Sud', 'Affiliation': 'Nepean Clinical School, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'J Owen', 'Initials': 'JO', 'LastName': 'Robinson', 'Affiliation': 'Royal Perth Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Archuleta', 'Affiliation': 'Division of Infectious Diseases, National University Hospital, Singapore.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Roberts', 'Affiliation': 'Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cass', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Paterson', 'Affiliation': 'Centre for Clinical Research, University of Queensland, Herston, Australia.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Foo', 'Affiliation': 'Department of Microbiology and Infectious Diseases, NSW Health Pathology, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Mical', 'Initials': 'M', 'LastName': 'Paul', 'Affiliation': 'Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Guy', 'Affiliation': 'Footscray Hospital, Western Health, Footscray, Victoria, Australia.'}, {'ForeName': 'Adrian R', 'Initials': 'AR', 'LastName': 'Tramontana', 'Affiliation': 'Footscray Hospital, Western Health, Footscray, Victoria, Australia.'}, {'ForeName': 'Genevieve B', 'Initials': 'GB', 'LastName': 'Walls', 'Affiliation': 'Department of Infectious Diseases, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'McBride', 'Affiliation': 'Department of Infectious Diseases, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Narin', 'Initials': 'N', 'LastName': 'Bak', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Niladri', 'Initials': 'N', 'LastName': 'Ghosh', 'Affiliation': 'Wollongong Public Hospital, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Rogers', 'Affiliation': 'School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Anna P', 'Initials': 'AP', 'LastName': 'Ralph', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Ferguson', 'Affiliation': 'Department of Infectious Diseases, Blacktown Hospital, Blacktown, New South Wales, Australia.'}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Dotel', 'Affiliation': 'Department of Infectious Diseases, Blacktown Hospital, Blacktown, New South Wales, Australia.'}, {'ForeName': 'Genevieve L', 'Initials': 'GL', 'LastName': 'McKew', 'Affiliation': 'Department of Microbiology and Infectious Diseases, Concord Repatriation General Hospital, Concord, New South Wales, Australia.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Gray', 'Affiliation': 'Department of Microbiology and Infectious Diseases, Concord Repatriation General Hospital, Concord, New South Wales, Australia.'}, {'ForeName': 'Natasha E', 'Initials': 'NE', 'LastName': 'Holmes', 'Affiliation': 'Department of Infectious Diseases, Austin Health, Austin Centre for Infection Research, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Cairns Hospital, Cairns, Queensland, Australia.'}, {'ForeName': 'Morgyn S', 'Initials': 'MS', 'LastName': 'Warner', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, Australia.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Kalimuddin', 'Affiliation': 'Department of Infectious Diseases, Singapore General Hospital, Singapore.'}, {'ForeName': 'Barnaby E', 'Initials': 'BE', 'LastName': 'Young', 'Affiliation': 'National Centre for Infectious Diseases, Singapore.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Runnegar', 'Affiliation': 'Infection Management Services, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Andresen', 'Affiliation': ""St Vincent's Public Hospital Sydney, Darlinghurst, New South Wales, Australia.""}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Anagnostou', 'Affiliation': 'Flinders Medical Centre, Adelaide, South Australia, Australia.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Johnson', 'Affiliation': 'Victorian Infectious Disease Service, Royal Melbourne Hospital, and University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Chatfield', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Vance G', 'Initials': 'VG', 'LastName': 'Fowler', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Howden', 'Affiliation': 'Department of Infectious Diseases, Austin Health, Austin Centre for Infection Research, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Meagher', 'Affiliation': 'Victorian Infectious Diseases Reference Laboratory Epidemiology Unit, Royal Melbourne Hospital, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Price', 'Affiliation': 'Victorian Infectious Diseases Reference Laboratory Epidemiology Unit, Royal Melbourne Hospital, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sebastiaan J', 'Initials': 'SJ', 'LastName': 'van Hal', 'Affiliation': 'Department of Microbiology and Infectious Disease, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Matthew V N', 'Initials': 'MVN', 'LastName': ""O'Sullivan"", 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Joshua S', 'Initials': 'JS', 'LastName': 'Davis', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.0103']
3375,32027349,Association of Visit Adherence and Visual Acuity in Patients With Neovascular Age-Related Macular Degeneration: Secondary Analysis of the Comparison of Age-Related Macular Degeneration Treatment Trial.,"Importance
Visit adherence has been shown to play a significant role in patient health outcomes. The effect of missing visits on visual acuity (VA) in individuals with neovascular age-related macular degeneration has yet to be characterized.
Objective
To quantify the association between patients' adherence to randomized clinical trial visits and VA in individuals with neovascular age-related macular degeneration based on 4 visit adherence metrics.
Design, Setting, and Participants
This is a secondary analysis of the Comparison of Age-Related Macular Degeneration Treatment Trial randomized clinical trial. Individuals with age-related macular degeneration were recruited from 44 clinical centers in the United States between February 2008 and December 2009. The 2-year study protocol required 1 visit every 4 weeks (every 21-35 days for a total of 26 visits) for monthly vs pro re nata treatments of bevacizumab vs ranibizumab. Analysis took place from November 2018 through May 2019.
Exposures
Visit adherence was measured in 4 ways: total number of missed visits, average number of days (avg days) between each visit, longest duration in days (max days) between visits, and visit constancy (the tally of 3-month periods with at least 1 visit attended). Average and max days were also categorized as on time (28-35 days), late (36-60 days), and very late (>60 days).
Main Outcomes and Measures
Change in Early Treatment Diabetic Retinopathy Study VA between the baseline and the last visit. Linear multivariate regression models were applied to analyze the association between visit adherence and change in VA, controlling for age, sex, baseline VA, anti-vascular endothelial growth factor drug, number of injections, and dosing regimen.
Results
Of 1178 patients, the mean (SD) age was 79.1 (7.3) years, and 727 (61.7%) were women. The mean (SD) number of missed visits was 2.4 (3.1). Overall, 1091 patients (92.6%) had complete visit constancy during the entire study period. Average days were categorized with 1060 patients (90.0%) classified as on time, 108 (9.2%) were late, and 10 (0.8%) were very late. For max days between visits, 197 patients (16.7%) were on time, 773 (65.6%) were late, and 208 (17.7%) were very late. After controlling for covariates, the late (avg days = -6.1; max days = -2.0) and very late (avg days = -12.5; max days = -5.9) groups saw fewer letters in both the avg and max days categories than patients in the on-time group (P < .001).
Conclusions and Relevance
These results provide evidence to support the concept that visit adherence contributes to VA outcomes in neovascular age-related macular degeneration. The magnitude of the association of visit adherence with VA outcomes in this clinical scenario suggests that substantial effort should be expended to strive for visit adherence or therapeutic strategies that reduce the visit burden without compromising VA outcomes.
Trial Registration
ClinicalTrials.gov Identifier: NCT00593450.",2020,"After controlling for covariates, the late (avg days = -6.1; max days = -2.0) and very late (avg days = -12.5; max days = ","['1178 patients', 'individuals with neovascular age-related macular degeneration', 'the mean (SD) age was 79.1 (7.3) years, and 727 (61.7%) were women', 'individuals with neovascular age-related macular degeneration based on 4 visit adherence metrics', 'Patients With Neovascular Age-Related Macular Degeneration', 'Individuals with age-related macular degeneration were recruited from 44 clinical centers in the United States between February 2008 and December 2009']",['bevacizumab vs ranibizumab'],"['Visit Adherence and Visual Acuity', 'mean (SD) number of missed visits', 'complete visit constancy', 'visual acuity (VA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.152998,"After controlling for covariates, the late (avg days = -6.1; max days = -2.0) and very late (avg days = -12.5; max days = ","[{'ForeName': 'Meera S', 'Initials': 'MS', 'LastName': 'Ramakrishnan', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Yinxi', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Center for Preventative Ophthalmology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'VanderBeek', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.4577']
3376,32178633,"Potential long-term impact of ""On The Move"" group-exercise program on falls and healthcare utilization in older adults: an exploratory analysis of a randomized controlled trial.","BACKGROUND
Wellness program participation may reduce the risk of falling, emergency department-use, and hospitalization among older adults. ""On the Move"" (OTM), a community-based group exercise program focused on the timing and coordination of walking, improved mobility in older adults, but its impact on falls, emergency department-use, and hospitalizations remains unclear. The aim of this preliminary study was to investigate the potential long-term effects that OTM may have on downstream, tertiary outcomes.
METHODS
We conducted a secondary analysis of a cluster-randomized, single-blind intervention trial, which compared two community-based, group exercise programs: OTM and a seated exercise program on strength, endurance, and flexibility (i.e. 'usual-care'). Program classes met for 50 min/session, 2 sessions/week, for 12 weeks. Older adults (≥65 years), with the ability to ambulate independently at ≥0.60 m/s were recruited. Self-reported incidence of falls, emergency department visitation, and hospitalization were assessed using automated monthly phone calls for the year following intervention completion. Participants with ≥1 completed phone call were included in the analyses. Incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were calculated (reference = usual-care).
RESULTS
Participants (n = 248) were similar on baseline characteristics and number of monthly phone calls completed. Participants in the seated exercise program attended an average of 2.9 more classes (p = .017). Of note, all results were not statistically significant (i.e. 95% CI overlapped a null value of 1.0). However, point estimates suggest OTM participation resulted in a decreased incidence rate of hospitalization compared to usual-care (IRR = 0.88; 95% CI = 0.59-1.32), and the estimates strengthened when controlling for between-group differences in attendance (adjusted IRR = 0.82; 95% CI = 0.56-1.21). Falls and emergency department visit incidence rates were initially greater for OTM participants, but decreased after controlling for attendance (adjusted IRR = 1.08; 95% CI = 0.72-1.62 and adjusted IRR = 0.96; 95% CI = 0.55-1.66, respectively).
CONCLUSION
Compared to a community-based seated group exercise program, participation in OTM may result in a reduced risk of hospitalization. When OTM is adhered to, the risk for falling and hospitalizations are attenuated. However, definitive conclusions cannot be made. Nevertheless, it appears that a larger randomized trial, designed to specifically evaluate the impact of OTM on these downstream health outcomes is warranted.
TRIAL REGISTRATION
Clinical trials.gov (NCT01986647; prospectively registered on November 18, 2013).",2020,Participants in the seated exercise program attended an average of 2.9 more classes (p = .017).,"['Older adults (≥65\u2009years), with the ability to ambulate independently at ≥0.60\u2009m/s were recruited', 'Participants (n\u2009=\u2009248', 'older adults', 'Participants with ≥1 completed phone call were included in the analyses']","[' group-exercise program', 'OTM', 'seated exercise program']","['Incidence rate ratios (IRRs) and 95% confidence intervals (CIs', 'Falls and emergency department visit incidence rates', 'incidence rate of hospitalization', 'falls and healthcare utilization', 'Self-reported incidence of falls, emergency department visitation, and hospitalization', 'strength, endurance, and flexibility']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0439493', 'cui_str': 'meter/second'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1303145', 'cui_str': 'Group exercise program'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",,0.203112,Participants in the seated exercise program attended an average of 2.9 more classes (p = .017).,"[{'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Coyle', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE, USA. pcoyle@udel.edu.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Department of Medicine (Division of Geriatric Medicine), University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Albert', 'Affiliation': 'Department of Behavioral and Community Health Science, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Freburger', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jessie M', 'Initials': 'JM', 'LastName': 'VanSwearingen', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Brach', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, USA.'}]",BMC geriatrics,['10.1186/s12877-020-1506-3']
3377,30466040,Randomized controlled trial of telephone monitoring with psychiatry inpatients with co-occurring substance use and mental health disorders.,"Background Psychiatry inpatients frequently have co-occurring substance use and mental health disorders, which are related to poor post-discharge outcomes. Telephone monitoring is effective in specialty substance use disorder treatment settings in increasing continuing care and 12-step program utilization and improving substance use outcomes. This study examined the effectiveness of telephone monitoring among psychiatry inpatients with co-occurring substance use and mental health disorders. Methods This randomized controlled trial (n = 406) compared usual care to usual care plus telephone monitoring (one in-person session during the inpatient stay, followed by weekly telephone contact for three months post-discharge). Follow-ups were conducted at end-of-intervention (three months post-baseline) and nine and 15 months post-baseline (73% followed). Primary outcomes were number of days out of the past 30 of drinking alcohol, using drugs, and experiencing psychological problems. Secondary outcomes were outpatient substance use treatment, and 12-step group, utilization. Results Longitudinal modeling found that patients in both conditions improved over time on each primary outcome. Improvement was comparable between conditions on alcohol and drug use and psychological problems. Receipt of outpatient treatment decreased over the follow-up period and was not related to condition. Likelihood of attending 12-step group meetings did not change over follow-ups, and was not related to condition. Conclusions Improvement over time was evident regardless of condition assignment. Patients maintained attendance at 12-step groups from pre- to post-discharge. Short-term telephone monitoring in addition to usual care for patients with co-occurring substance use and mental health disorders may not be sufficiently intensive to achieve additional improvements on outcomes.",2019,"Likelihood of attending 12-step group meetings did not change over follow-ups, and was not related to condition.","['psychiatry inpatients with co-occurring substance use and mental health disorders', 'patients with co-occurring substance use and mental health disorders', ' Psychiatry inpatients frequently have co-occurring substance use and mental health disorders']","['telephone monitoring', 'usual care to usual care plus telephone monitoring (one in-person session', 'Telephone monitoring', 'telephone']","['outpatient substance use treatment, and 12-step group, utilization', 'number of days out of the past 30 of drinking alcohol, using drugs, and experiencing psychological problems']","[{'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0150359', 'cui_str': 'Substance use treatments and procedures'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",,0.0531996,"Likelihood of attending 12-step group meetings did not change over follow-ups, and was not related to condition.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Timko', 'Affiliation': 'Center for Innovation to Implementation, Department of Veterans Affairs Health Care System, Palo Alto, CA, 94304, USA; Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, 94305, USA. Electronic address: ctimko@stanford.edu.'}, {'ForeName': 'Alex H S', 'Initials': 'AHS', 'LastName': 'Harris', 'Affiliation': 'Center for Innovation to Implementation, Department of Veterans Affairs Health Care System, Palo Alto, CA, 94304, USA; Department of Surgery, Stanford University School of Medicine, Stanford, CA, 94305, USA. Electronic address: Alexander.Harris2@va.gov.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Jannausch', 'Affiliation': 'Department of Psychiatry, University of Michigan School of Medicine, 4250 Plymouth Road, Ann Arbor, MI, 48109, USA; Center for Clinical Management Research (CCMR), VA Ann Arbor Healthcare System, 2800 Plymouth Road, Building 16, Ann Arbor, MI, 48109, USA. Electronic address: mjann@med.umich.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ilgen', 'Affiliation': 'Department of Psychiatry, University of Michigan School of Medicine, 4250 Plymouth Road, Ann Arbor, MI, 48109, USA; Center for Clinical Management Research (CCMR), VA Ann Arbor Healthcare System, 2800 Plymouth Road, Building 16, Ann Arbor, MI, 48109, USA. Electronic address: marki@med.umich.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2018.09.010']
3378,31525441,"A regimen to minimize pain during blue light photodynamic therapy of actinic keratoses: Bilaterally controlled, randomized trial of simultaneous versus conventional illumination.","BACKGROUND
Blue light photodynamic therapy (PDT) is effective for actinic keratosis, but many patients experience stinging pain during illumination.
OBJECTIVE
To compare a conventional regimen (1 hour of 5-aminolevulinic acid [ALA] preincubation, followed by blue light) versus a new modified regimen in which blue light is started immediately after ALA application.
METHODS
A clinical trial with a bilaterally controlled, intrapatient study design was conducted with 23 patients. Topical 20% ALA was applied to the entire face and/or scalp. On 1 side of the body, blue light was started immediately and continued for either 30, 45, or 60 minutes (simultaneous PDT). On the contralateral side, the blue light began 1 hour after ALA application and lasted 1000 seconds (conventional PDT). Pain was evaluated on a scale from 0 to 10. Actinic keratosis lesion counts were determined by clinical examination and photography.
RESULTS
All patients experienced significantly less pain during simultaneous illumination than during the conventional regimen. At 3 months after treatment, lesion clearance was nearly identical on the 2 sides, as determined by statistical testing of noninferiority ± 15% margin.
LIMITATIONS
Although bilaterally controlled, the study was relatively small. Additional studies are recommended.
CONCLUSION
The modified PDT regimen is essentially painless, yet it provides treatment efficacy similar to a conventional regimen.",2020,"At 3 months post-treatment, lesion clearance was nearly identical on the two sides, as determined by statistical testing of non-inferiority ± 15% margin.
","['23 patients', 'actinic keratoses']","['conventional regimen (1 h ALA preincubation, followed by blue light', 'Blue light photodynamic therapy (PDT', 'Topical 20% ALA', 'conventional illumination']","['lesion clearance', 'Pain', 'pain', 'AK lesion counts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0303896', 'cui_str': 'Blue light (physical force)'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1964256', 'cui_str': 'Illumination - action'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",1000.0,0.0120254,"At 3 months post-treatment, lesion clearance was nearly identical on the two sides, as determined by statistical testing of non-inferiority ± 15% margin.
","[{'ForeName': 'Urvashi', 'Initials': 'U', 'LastName': 'Kaw', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Muneeb', 'Initials': 'M', 'LastName': 'Ilyas', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Bullock', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rittwage', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Riha', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Vidimos', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Warren', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Maytin', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio. Electronic address: maytine@ccf.org.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.09.010']
3379,31542406,"Greater efficacy of SPF 100+ sunscreen compared with SPF 50+ in sunburn prevention during 5 consecutive days of sunlight exposure: A randomized, double-blind clinical trial.","BACKGROUND
Beach vacations are high-risk settings for overexposure to ultraviolet radiation.
OBJECTIVE
To compare the sunburn protective efficacy of SPF 50+ and SPF 100+ sunscreens under actual use at the beach.
METHODS
A prospective, randomized, double-blind, single-center, split-body/face study of 55 healthy individuals. Each participant applied both sunscreens to randomized sides of the face/body for up to 5 consecutive days. Blinded clinical evaluation of erythema by a single grader and objective instrumental assessments, colorimetry, and diffuse reflectance spectroscopy were performed the morning after each sun exposure.
RESULTS
After 5 days, 31 (56%) participants had more sunburn on the SPF 50+ side compared to 4 (7%) on the SPF 100+ side. Overall, mean erythema intensity showed statistically significantly less erythema on the SPF 100+ side compared with the SPF 50+ side. The first observation of sunburn exclusively on the SPF 50+ side occurred after 1 day of sun exposure, whereas that for SPF 100+ occurred after 3 days of sun exposure.
LIMITATIONS
Only initial sunscreen application was monitored, only 1 participant with skin phototype I was recruited, and participants were recruited from a local beach area.
CONCLUSION
SPF 100+ was significantly more effective in protecting against ultraviolet radiation-induced erythema and sunburn than SPF 50+ in actual use in a beach vacation setting.",2020,SPF 100+ was significantly more effective in protecting against UV-induced erythema and sunburn than SPF 50+ in actual use within a beach vacation setting.,"['one skin-phototype I subject was recruited, and subjects were recruited from local beach area', '55 healthy subjects']","['SPF 50+ and SPF 100+ sunscreens', 'SPF 100+ sunscreen']",['mean erythema intensity'],"[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0331781', 'cui_str': 'Beach (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0038818', 'cui_str': 'Sunscreens'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",55.0,0.182889,SPF 100+ was significantly more effective in protecting against UV-induced erythema and sunburn than SPF 50+ in actual use within a beach vacation setting.,"[{'ForeName': 'Indermeet', 'Initials': 'I', 'LastName': 'Kohli', 'Affiliation': 'Department of Dermatology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Nicholson', 'Affiliation': 'Department of Dermatology, Henry Ford Hospital, Detroit, Michigan; Department of Dermatology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Williams', 'Affiliation': 'Johnson & Johnson Consumer Inc, Skillman, New Jersey.'}, {'ForeName': 'Alexis B', 'Initials': 'AB', 'LastName': 'Lyons', 'Affiliation': 'Department of Dermatology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'InSeok', 'Initials': 'I', 'LastName': 'Seo', 'Affiliation': 'Johnson & Johnson Consumer Inc, Skillman, New Jersey.'}, {'ForeName': 'Prithwiraj', 'Initials': 'P', 'LastName': 'Maitra', 'Affiliation': 'Johnson & Johnson Consumer Inc, Skillman, New Jersey.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Johnson & Johnson Consumer Inc, Skillman, New Jersey.'}, {'ForeName': 'Evren', 'Initials': 'E', 'LastName': 'Atillasoy', 'Affiliation': 'Johnson & Johnson Consumer Inc, Skillman, New Jersey.'}, {'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Lim', 'Affiliation': 'Department of Dermatology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Iltefat H', 'Initials': 'IH', 'LastName': 'Hamzavi', 'Affiliation': 'Department of Dermatology, Henry Ford Hospital, Detroit, Michigan. Electronic address: Ihamzav1@hfhs.org.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.09.018']
3380,31586600,Efficacy and tolerability of an investigational nitric oxide-releasing topical gel in patients with molluscum contagiosum: A randomized clinical trial.,"BACKGROUND
Although a variety of ablative, topical, and systemic therapies are used for molluscum contagiosum (MC), none has been well studied or approved by the US Food and Drug Administration.
OBJECTIVES
To compare the efficacy and tolerability of topical SB206 (berdazimer sodium gel coadministered with hydrogel) with vehicle.
METHODS
A 12-week, phase 2, multicenter, randomized, double-blind, vehicle-controlled clinical trial of topical SB206.
RESULTS
A total of 256 patients (mean age, approximately 7 years) participated. Of patients who completed 12 weeks of treatment (n = 217), all MC lesions cleared in 20.0% of patients who received vehicle compared with 13.2%, 41.0%, and 35.1% of patients treated with twice daily SB206 4%, 8%, and 12%, respectively, and 41.9% of patients treated with once daily SB206 12%. Application-site erythema occurred in 10.6% of patients treated with SB206. Application-site reactions were the most common adverse events leading to treatment discontinuation, affecting 2 patients (approximately 4%) in each of the SB206 4%, 8%, and 12% twice daily groups and 0 patients in the vehicle or SB206 12% once daily groups.
LIMITATIONS
A larger study is needed to confirm the efficacy of SB206 12% once daily and provide additional safety assessments.
CONCLUSION
Of the doses studied, SB206 12% applied once daily provided the best balance between MC lesion clearance and tolerability for evaluation in a larger study.",2020,"Application-site reactions were the most common AEs leading to treatment discontinuation, affecting 2 patients (∼4%) in each of the SB206 4%, 8%, and 12% BID groups and 0 patients in the vehicle or SB206 12% QD groups.
","['Patients With Molluscum Contagiosum', '256 patients ', 'mean age, ∼7 years']","['topical SB206', 'Investigational Nitric Oxide-releasing Topical Gel', 'topical SB206 (berdazimer sodium gel coadministered with hydrogel) with vehicle']","['Application-site erythema', 'MC lesions cleared', 'Efficacy and Tolerability', 'efficacy and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026393', 'cui_str': 'Molluscum Contagiosum'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1160728', 'cui_str': 'Topical Gel'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}]","[{'cui': 'C0853700', 'cui_str': 'Application site erythema'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}]",256.0,0.211718,"Application-site reactions were the most common AEs leading to treatment discontinuation, affecting 2 patients (∼4%) in each of the SB206 4%, 8%, and 12% BID groups and 0 patients in the vehicle or SB206 12% QD groups.
","[{'ForeName': 'Adelaide A', 'Initials': 'AA', 'LastName': 'Hebert', 'Affiliation': 'UTHealth McGovern Medical School, Houston, Texas.'}, {'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Siegfried', 'Affiliation': 'Saint Louis University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Durham', 'Affiliation': 'Novan, Inc, Morrisville, North Carolina.'}, {'ForeName': 'Emily N', 'Initials': 'EN', 'LastName': 'de León', 'Affiliation': 'Novan, Inc, Morrisville, North Carolina.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Reams', 'Affiliation': 'Novan, Inc, Morrisville, North Carolina.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Messersmith', 'Affiliation': 'Novan, Inc, Morrisville, North Carolina.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Maeda-Chubachi', 'Affiliation': 'Novan, Inc, Morrisville, North Carolina. Electronic address: tmaeda-chubachi@novan.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.09.064']
3381,31999170,A web-based episodic specificity and future thinking session modulates delay discounting in cannabis users.,"Episodic future thinking (EFT), a brief intervention involving mental simulation of positive future events, improves delay discounting (DD) in nicotine and alcohol dependent individuals. This study is the first to assess effects of a single-session, online episodic training (ET) on constructs that might impact cannabis use and cannabis use disorder. A sample of 200 active cannabis users recruited via Amazon Mechanical Turk were randomized to an EFT group ( n = 102) or an episodic recent thinking control group (ERT; n = 98). A novel episodic specificity induction (ES) was included to enhance quality of episodic thinking for the ET group, and an ES attention control was provided to the ERT group (control training group; CT). Quality and manipulation ratings of event excitement, vividness, importance, and enjoyment of trainings were collected in addition to DD tasks (gains and losses) and readiness to change cannabis use. The ET group reported higher overall quality and manipulation ratings than did the CT group ( p < .001, d = 0.79). DD of gains was lower in the ET relative to those of the CT group after controlling for relevant variables ( p = .003, d = 0.48), unlike DD of losses ( p = .50, d = 0.11). The ET group showed larger pre/post increases in readiness to change, but they were not statistically significant ( p = .069, d = 0.26). These effects, following a session of online ET, suggests that ET may positively impact factors related to reduction in cannabis use. Differential effects of EFT and ES components on DD and the development of ET as an adjunctive mHealth intervention targeting reduction in cannabis use appears warranted. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The ET group reported higher overall quality and manipulation ratings than did the CT group ( p < .001, d = 0.79).","['cannabis users', '200 active cannabis users recruited via Amazon Mechanical Turk', 'nicotine and alcohol dependent individuals']","['single-session, online episodic training (ET', 'EFT', 'EFT and ES components', 'Episodic future thinking (EFT', 'episodic recent thinking control group (ERT', 'CT']","['DD tasks (gains and losses) and readiness to change cannabis use', 'delay discounting (DD', 'quality of episodic thinking', 'Quality and manipulation ratings of event excitement, vividness, importance, and enjoyment of trainings', 'overall quality and manipulation ratings']","[{'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0337911', 'cui_str': 'Turks (ethnic group)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C3850035', 'cui_str': 'Intertemporal Decision Making'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0233571', 'cui_str': 'Excitement (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",200.0,0.0701875,"The ET group reported higher overall quality and manipulation ratings than did the CT group ( p < .001, d = 0.79).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sofis', 'Affiliation': 'Center for Technology and Behavioral Health.'}, {'ForeName': 'Shea M', 'Initials': 'SM', 'LastName': 'Lemley', 'Affiliation': 'Center for Technology and Behavioral Health.'}, {'ForeName': 'Dustin C', 'Initials': 'DC', 'LastName': 'Lee', 'Affiliation': 'Behavioral Pharmacology Research Unit.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Budney', 'Affiliation': 'Center for Technology and Behavioral Health.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000557']
3382,32053162,Neuro-Ophthalmologic Response to Repetitive Subconcussive Head Impacts: A Randomized Clinical Trial.,"Importance
Subconcussive head impacts have emerged as a complex public health concern. The oculomotor system is sensitive to brain trauma; however, neuro-ophthalmologic response to subconcussive head impacts remains unclear.
Objective
To examine whether subconcussive head impacts cause impairments in neuro-ophthalmologic function as measured by the King-Devick test (KDT) and oculomotor function as measured by the near point of convergence.
Design, Setting, and Participants
In this randomized clinical trial, adult soccer players were randomized into either a heading group or kicking (control) group. The heading group executed 10 headers with soccer balls projected at a speed of 25 mph. The kicking-control group followed the same protocol but with 10 kicks. Peak linear and rotational head accelerations were assessed with a triaxial accelerometer. The KDT speed and error and near point of convergence were assessed at baseline (preheading or prekicking) and at 0, 2, and 24 hours after heading or kicking.
Exposures
Ten soccer-ball headings or kicks.
Main Outcomes and Measures
The primary outcome was the group-by-time interaction of KDT speed at 0 hours after heading or kicking. The secondary outcomes included KDT speed at 2 hours and 24 hours after heading or kicking, KDT error, and near point of convergence.
Results
A total of 78 individuals enrolled (heading group, n = 40; kicking-control group, n = 38). Eleven individuals (heading group: 4 women; mean [SD] age, 22.5 [1.0] years; kicking-control group, 3 women and 4 men; mean [SD] age, 20.9 [1.1] years) voluntarily withdrew from the study. Data from 67 participants with a mean (SD) age of 20.6 (1.7) years were eligible for analysis (heading, n = 36; kicking-control, n = 31). Mean (SD) peak linear accelerations and peak rotational accelerations per impact for the heading group were 33.2 (6.8) g and 3.6 (1.4) krad/s2, respectively. Conversely, soccer kicking did not induce a detectable level of head acceleration. Both groups showed improvements in KDT speed (heading group: 0 hours, -1.2 [95% CI, -2.2 to -0.1] seconds; P = .03; 2 hours, -1.3 [95% CI, -2.6 to 0] seconds; P = .05; 24 hours, -3.2 [95% CI, -4.3 to -2.2] seconds; P < .001; kicking-control group: 0 hours, -3.3 [95% CI, -4.1 to -2.5] seconds; P < .001; 2 hours, -4.1 [95% CI, -5.1 to -3.1] seconds; P < .001; 24 hours, -5.2 [95% CI, -6.2 to -4.2] seconds; P < .001). Group differences occurred at all postintervention points; the kicking-control group performed KDT faster at 0 hours (-2.2 [95% CI, -0.8 to -3.5] seconds; P = .001), 2 hours (-2.8 [95% CI, -1.2 to -4.4] seconds; P < .001), and 24 hours after the intervention (-2.0 [95% CI, -0.5 to -3.4] seconds; P = .007) compared with those of the heading group.
Conclusions and Relevance
These data support the hypothesis that neuro-ophthalmologic function is affected, at least in the short term, by subconcussive head impacts that may affect some individuals in some contact sports. Further studies may help determine if these measures can be a useful clinical tool in detecting acute subconcussive injury.
Trial Registration
ClinicalTrials.gov Identifier: NCT03488381.",2020,"Group differences occurred at all postintervention points; the kicking-control group performed KDT faster at 0 hours (-2.2 [95% CI, -0.8 to -3.5] seconds; P = .001), 2 hours (-2.8 [95% CI, -1.2 to -4.4] seconds; P < .001), and 24 hours after the intervention (-2.0 [95% CI, -0.5 to -3.4] seconds; P = .007) compared with those of the heading group.
","['78 individuals enrolled (heading group, n\u2009=\u200940; kicking-control group, n\u2009=\u200938', 'Exposures\n\n\nTen soccer-ball headings or kicks', 'Eleven individuals (heading group: 4 women; mean [SD] age, 22.5 [1.0] years; kicking-control group, 3 women and 4 men; mean [SD] age, 20.9 [1.1] years) voluntarily withdrew from the study', '67 participants with a mean (SD) age of 20.6 (1.7) years were eligible for analysis (heading, n\u2009=\u200936; kicking-control, n\u2009=\u200931', 'adult soccer players']","['heading group or kicking (control', 'Repetitive Subconcussive Head Impacts']","['King-Devick test (KDT) and oculomotor function', 'KDT speed', 'group-by-time interaction of KDT speed', 'Mean (SD) peak linear accelerations and peak rotational accelerations per impact', 'KDT speed at 2 hours and 24 hours after heading or kicking, KDT error, and near point of convergence', 'Peak linear and rotational head accelerations', 'KDT speed and error and near point of convergence']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}]","[{'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0445237', 'cui_str': 'Rotational (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0429572', 'cui_str': 'Near point'}, {'cui': 'C0443193', 'cui_str': 'Convergence (qualifier value)'}]",78.0,0.191191,"Group differences occurred at all postintervention points; the kicking-control group performed KDT faster at 0 hours (-2.2 [95% CI, -0.8 to -3.5] seconds; P = .001), 2 hours (-2.8 [95% CI, -1.2 to -4.4] seconds; P < .001), and 24 hours after the intervention (-2.0 [95% CI, -0.5 to -3.4] seconds; P = .007) compared with those of the heading group.
","[{'ForeName': 'Madeleine K', 'Initials': 'MK', 'LastName': 'Nowak', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington.'}, {'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Bevilacqua', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Ejima', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Huibregtse', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington.'}, {'ForeName': 'Zhongxue', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Mickleborough', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington.'}, {'ForeName': 'Sharlene D', 'Initials': 'SD', 'LastName': 'Newman', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University College of Arts and Sciences, Bloomington.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Kawata', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.6128']
3383,31930358,An Athletic Coach-Delivered Middle School Gender Violence Prevention Program: A Cluster Randomized Clinical Trial.,"Importance
Adolescent relationship abuse (ARA) and sexual violence (SV) reported among adolescents point to the need for prevention among middle school-age youths.
Objective
To test an athletic coach-delivered relationship abuse and sexual violence prevention program among middle school male athletes.
Design, Setting, and Participants
An unblinded cluster randomized clinical trial from spring 2015 to fall 2017 at 41 middle schools (38 clusters). The study included 973 male middle school athletes (ages 11-14 years; grades 6-8; participation rate 50%) followed up for 1 year (retention 86%).
Interventions
Coaching Boys Into Men (CBIM) is a prevention program that trains athletic coaches to talk to male athletes about (1) respectful relationship behaviors, (2) promoting more gender-equitable attitudes, and (3) positive bystander intervention when harmful behaviors among peers are witnessed.
Main Outcomes and Measures
The primary outcome was change in positive bystander behaviors (ie, intervening in peers' disrespectful or harmful behaviors); secondary outcomes were changes in recognition of what constitutes abusive behavior, intentions to intervene, gender-equitable attitudes, and reduction in recent ARA/SV perpetration (at end of sports season and 1-year follow up).
Results
Of the 973 participants, 530 were white (54.5%), 282 were black (29.0%), 14 were Hispanic (1.4%), and the remainder were multiracial, other race/ethnicity, or not reported. Positive bystander behaviors increased at end of sports season and at 1-year follow-up (relative risk, 1.51; 95% CI, 1.06-2.16 and 1.53; 95% CI, 1.10-2.12, respectively) as did recognition of abuse (mean risk difference, 0.14; 95% CI, 0.01-0.27 and 0.14; 95% CI, 0.00-0.28, respectively). At 1-year follow-up, among those who ever dated, athletes on teams receiving CBIM had lower odds of reporting recent ARA/SV perpetration (odds ratio, 0.24; 95% CI, 0.09-0.65). Gender attitudes and intentions to intervene did not differ between study arms. In exploratory intensity-adjusted and per protocol analyses, athletes on teams receiving CBIM were more likely to report positive bystander behaviors and to endorse equitable gender attitudes and less likely to report ARA and sexual harassment perpetration 1 year later.
Conclusions and Relevance
An athletic coach-delivered program for middle school male athletes is an effective strategy for reducing relationship abuse among younger adolescents.
Trial Registration
ClinicalTrials.gov Identifier: NCT02331238.",2020,"An athletic coach-delivered program for middle school male athletes is an effective strategy for reducing relationship abuse among younger adolescents.
","[' 530 were white (54.5%), 282 were black (29.0%), 14 were Hispanic (1.4%), and the remainder were multiracial, other race/ethnicity, or not reported', 'spring 2015 to fall 2017 at 41 middle schools (38 clusters', 'younger adolescents', 'middle school-age youths', '973 participants', 'middle-school male athletes', '973 male middle school athletes (ages 11-14 years; grades 6-8; participation rate 50%) followed up for 1 year (retention 86', 'middle school male athletes']","['Interventions\n\n\nCoaching Boys Into Men (CBIM', 'Athletic Coach-Delivered Middle School Gender Violence Prevention Program', 'athletic coach-delivered program', 'athletic coach-delivered relationship abuse and sexual violence prevention program']","['Importance\n\n\nAdolescent relationship abuse (ARA) and sexual violence (SV', ""positive bystander behaviors (ie, intervening in peers' disrespectful or harmful behaviors); secondary outcomes were changes in recognition of what constitutes abusive behavior, intentions to intervene, gender-equitable attitudes, and reduction in recent ARA/SV perpetration (at end of sports season and 1-year follow up"", 'Gender attitudes and intentions to intervene', 'Positive bystander behaviors']","[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]","[{'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0237220', 'cui_str': 'Abusive behavior (finding)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",973.0,0.124896,"An athletic coach-delivered program for middle school male athletes is an effective strategy for reducing relationship abuse among younger adolescents.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Kelley A', 'Initials': 'KA', 'LastName': 'Jones', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ripper', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Paglisotti', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mulbah', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh, School of Medicine, Pittsburgh, Pennsylvania.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.5217']
3384,31907026,"Safety, tolerability, and pharmacokinetics of repeated oral doses of 2-hydroxybenzylamine acetate in healthy volunteers: a double-blind, randomized, placebo-controlled clinical trial.","BACKGROUND
2-Hydroxybenzylamine (2-HOBA) is a selective dicarbonyl electrophile scavenger being developed as a nutritional supplement to help protect against the development of conditions associated with dicarbonyl electrophile formation, such as the cognitive decline observed with Mild Cognitive Impairment or Alzheimer's disease.
METHODS
This study evaluated the safety, tolerability, and pharmacokinetics of repeated oral doses of 2-HOBA acetate (500 or 750 mg) administered to healthy volunteers every eight hours for two weeks. The effects of 2-HOBA on cyclooxygenase function and cerebrospinal fluid penetrance of 2-HOBA were also investigated.
RESULTS
Repeated oral administration of 2-HOBA was found to be safe and well-tolerated up to 750 mg TID for 15 days. 2-HOBA was absorbed within 2 h of administration, had a half-life of 2.10-3.27 h, and an accumulation ratio of 1.38-1.52. 2-HOBA did not interfere with cyclooxygenase function and was found to be present in cerebrospinal fluid 90 min after dosing.
CONCLUSIONS
Repeated oral administration of 2-HOBA was found to be safe and well-tolerated. These results support continued development of 2-HOBA as a nutritional supplement.
TRIAL REGISTRATION
Studies are registered at ClinicalTrials.gov (NCT03555682 Registered 13 June 2018, NCT03554096 Registered 12 June 18).",2020,"2-HOBA was absorbed within 2 h of administration, had a half-life of 2.10-3.27 h, and an accumulation ratio of 1.38-1.52.","['healthy volunteers', 'healthy volunteers every eight hours for two weeks']","['2-hydroxybenzylamine acetate', '2-Hydroxybenzylamine (2-HOBA', '2-HOBA acetate', 'placebo', '2-HOBA']","['cyclooxygenase function and cerebrospinal fluid penetrance of 2-HOBA', 'safety, tolerability, and pharmacokinetics', 'safe and well-tolerated', 'Safety, tolerability, and pharmacokinetics', '2-HOBA']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0585326', 'cui_str': 'Every eight hours (qualifier value)'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}]","[{'cui': 'C0093142', 'cui_str': '2-hydroxybenzylamine'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0033551', 'cui_str': 'Prostaglandin H2 Synthetase'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0007807'}, {'cui': 'C0524899', 'cui_str': 'Penetrance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.160547,"2-HOBA was absorbed within 2 h of administration, had a half-life of 2.10-3.27 h, and an accumulation ratio of 1.38-1.52.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Pitchford', 'Affiliation': 'MTI BioTech, Inc., Ames, IA, 50010, USA. pitchford@mti-hmb.com.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Driver', 'Affiliation': 'Department of Medicine, Division of Clinical Pharmacology, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Fuller', 'Affiliation': 'MTI BioTech, Inc., Ames, IA, 50010, USA.'}, {'ForeName': 'Wendell S', 'Initials': 'WS', 'LastName': 'Akers', 'Affiliation': 'Department of Pharmaceutical Sciences, Lipscomb University College of Pharmacy, Nashville, TN, 37204, USA.'}, {'ForeName': 'Naji N', 'Initials': 'NN', 'LastName': 'Abumrad', 'Affiliation': 'Department of Surgery, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'Venkataraman', 'Initials': 'V', 'LastName': 'Amarnath', 'Affiliation': 'Department of Medicine, Division of Clinical Pharmacology, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'Ginger L', 'Initials': 'GL', 'LastName': 'Milne', 'Affiliation': 'Department of Medicine, Division of Clinical Pharmacology, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'Sheau-Chiann', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'L Jackson', 'Initials': 'LJ', 'LastName': 'Roberts', 'Affiliation': 'Department of Medicine, Division of Clinical Pharmacology, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'M Benjamin', 'Initials': 'MB', 'LastName': 'Shoemaker', 'Affiliation': 'Department of Medicine, Division of Cardiology, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Oates', 'Affiliation': 'Department of Medicine, Division of Clinical Pharmacology, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Rathmacher', 'Affiliation': 'MTI BioTech, Inc., Ames, IA, 50010, USA.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Boutaud', 'Affiliation': 'Department of Pharmacology, Division of Clinical Pharmacology, Vanderbilt University, Nashville, TN, 37232, USA.'}]",BMC pharmacology & toxicology,['10.1186/s40360-020-0382-y']
3385,32164542,Study protocol of a quasi-experimental trial to compare two models of home care for older people in the primary setting.,"BACKGROUND
Preventive home visits are suited for patients with reduced mobility, such as older people. Healthcare needs for older patients are expected to increase due to the extended life expectancy estimated in coming years. The implementation of low-cost, patient-centered methodologies may buffer this rise in health care costs without affecting the quality of service. In order to find the best home care model with less investment, this paper describes a study protocol comparing two models of home care for older people.
METHODS
We describe a quasi-experimental study that compares the outcome of two different home care models already implemented in two primary care centers in Badalona (Barcelona, Spain). The traditional model (control model) is integrated in the sense that is continuous, the same primary care center team looks after its assigned patients both at the center and in preventive home visits. The new functional home care model (study model), consisting of a highly trained team, is specifically designed to meet patient needs and give total attention to preventive home interventions. The study will start and end on the expected dates, June 2018 to October 2020, and include all patients over 65 years old already enrolled in the home care programs of the primary care centers selected. The primary endpoint assessed will be the difference in hospitalization days between patients included in both home care programs. Other variables regarding health status, quality of care and resource utilization will also be compared between the two models.
DISCUSSION
The study in progress will assess whether a functional and highly trained home care team will meet the ever-aging population needs in terms of cost and health outcomes better than a traditional, integrated one. Lessons learned from this pilot study will provide guidelines for a future model of home care based on the IHI Triple Aim: better care, better health, and lower costs.
TRIAL REGISTRATION
Registered in ClinicalTrials.gov (Identifier: NCT03461315; March 12, 2018).",2020,"The implementation of low-cost, patient-centered methodologies may buffer this rise in health care costs without affecting the quality of service.","['older people in the primary setting', 'patients with reduced mobility, such as older people', 'expected dates, June 2018 to October 2020, and include all patients over 65\u2009years old already enrolled in the home care programs of the primary care centers selected', 'two primary care centers in Badalona (Barcelona, Spain', 'older patients', 'older people']",[],"['health status, quality of care and resource utilization', 'hospitalization days']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0476650', 'cui_str': 'Reduced mobility'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],"[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.0299606,"The implementation of low-cost, patient-centered methodologies may buffer this rise in health care costs without affecting the quality of service.","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Burgos-Díez', 'Affiliation': 'Department of Surgery and Surgical Specializations, Faculty of Medicine, University of Barcelona (PC 08036), Barcelona, Catalonia, Spain.'}, {'ForeName': 'Rosa Maria', 'Initials': 'RM', 'LastName': 'Sequera-Requero', 'Affiliation': 'Primary Care Center Gran Sol, Institut Català de la Salut, Badalona, Catalonia, Spain.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Tarazona-Santabalbina', 'Affiliation': 'Geriatric Medicine Department, Hospital Universitario de la Ribera, Alzira, Valencia, Spain.'}, {'ForeName': 'Joan Carles', 'Initials': 'JC', 'LastName': 'Contel-Segura', 'Affiliation': 'Chronic Care Program, Ministry of Health, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Marià', 'Initials': 'M', 'LastName': 'Monzó-Planella', 'Affiliation': 'Department of Surgery and Surgical Specializations, Faculty of Medicine, University of Barcelona (PC 08036), Barcelona, Catalonia, Spain.'}, {'ForeName': 'Sebastià Josep', 'Initials': 'SJ', 'LastName': 'Santaeugènia-González', 'Affiliation': 'Chronic Care Program, Ministry of Health, Barcelona, Catalonia, Spain. sebastia.santaeugenia@gencat.cat.'}]",BMC geriatrics,['10.1186/s12877-020-1497-0']
3386,31876900,Efficacy and Safety of Multiple Dupilumab Dose Regimens After Initial Successful Treatment in Patients With Atopic Dermatitis: A Randomized Clinical Trial.,"Importance
The dupilumab regimen of 300 mg every 2 weeks is approved for uncontrolled, moderate to severe atopic dermatitis (AD).
Objective
To assess the efficacy and safety of different dupilumab regimens in maintaining response after 16 weeks of initial treatment.
Design, Setting, and Participants
The Study to Confirm the Efficacy and Safety of Different Dupilumab Dose Regimens in Adults With Atopic Dermatitis (LIBERTY AD SOLO-CONTINUE) was a randomized, double-blind, phase 3 clinical trial conducted from March 25, 2015, to October 18, 2016, at 185 sites in North America, Europe, Asia, and Japan. Patients with moderate to severe AD who received dupilumab treatment and achieved an Investigator's Global Assessment score of 0 or 1 or 75% improvement in Eczema Area and Severity Index scores (EASI-75) at week 16 in 2 previous dupilumab monotherapy trials (LIBERTY AD SOLO 1 and 2) were rerandomized in SOLO-CONTINUE. After completing SOLO-CONTINUE, patients were followed up for up to 12 weeks or enrolled in an open-label extension. Data were analyzed from December 5 to 12, 2016.
Interventions
High-responding patients treated with dupilumab in SOLO were rerandomized 2:1:1:1 to continue their original regimen of dupilumab, 300 mg, weekly or every 2 weeks or to receive dupilumab, 300 mg, every 4 or 8 weeks or placebo for 36 weeks.
Main Outcomes and Measures
Percentage change in EASI score from baseline during the SOLO-CONTINUE trial, percentage of patients with EASI-75 at week 36, and safety.
Results
Among the 422 patients (mean [SD] age, 38.2 [14.5] years; 227 [53.8%] male), continuing dupilumab treatment once weekly or every 2 weeks maintained optimal efficacy, with negligible change in percent EASI improvement from SOLO 1 and 2 baseline during the SOLO-CONTINUE trial (-0.06%; P < .001 vs placebo); percent change with the other regimens dose-dependently worsened (dupilumab every 4 weeks, -3.84%; dupilumab every 8 weeks, -6.84%; placebo, -21.67%). More patients taking dupilumab weekly or every 2 weeks (116 of 162 [71.6%]; P < .001 vs placebo) maintained EASI-75 response than those taking dupilumab every 4 weeks (49 of 84 [58.3%]) or every 8 weeks (45 of 82 [54.9%]) or those taking placebo (24 of 79 [30.4%]). Overall adverse event incidences were 70.7% in the weekly or every 2 weeks group, 73.6% in the every 4 weeks group, 75.0% in the every 8 weeks group, and 81.7% in the placebo group. Treatment groups had similar conjunctivitis rates. Treatment-emergent antidrug antibody incidence was lower with more frequent dupilumab dose regimens (11.3% in the placebo group and 11.7%, 6.0%, 4.3%, and 1.2% in the dupilumab every 8 weeks, every 4 weeks, every 2 weeks, and weekly groups, respectively).
Conclusions and Relevance
In this trial, continued response over time was most consistently maintained with dupilumab administered weekly or every 2 weeks. Longer dosage intervals and placebo resulted in a diminution of response for both continuous and categorical end points. No new safety signals were observed. The approved regimen of 300 mg of dupilumab every 2 weeks is recommended for long-term treatment.
Trial Registration
ClinicalTrials.gov identifier: NCT02395133.",2020,More patients taking dupilumab weekly or every 2 weeks (116 of 162 [71.6%]; P < .001 vs placebo) maintained EASI-75 response than those taking dupilumab every 4 weeks (49 of 84 [58.3%]) or every 8 weeks (45 of 82 [54.9%]) or those taking placebo (24 of 79 [30.4%]).,"['Adults With Atopic Dermatitis (LIBERTY AD SOLO-CONTINUE) was a randomized, double-blind, phase 3 clinical trial conducted from March 25, 2015, to October 18, 2016, at 185 sites in North America, Europe, Asia, and Japan', '422 patients (mean [SD] age, 38.2 [14.5] years; 227 [53.8%] male', 'uncontrolled, moderate to severe atopic dermatitis (AD', 'Patients with moderate to severe AD', 'Patients With Atopic Dermatitis', 'Interventions\n\n\nHigh-responding patients treated with dupilumab in SOLO']","['placebo', 'dupilumab regimens', 'dupilumab', 'Multiple Dupilumab Dose Regimens']","['efficacy and safety', 'Overall adverse event incidences', 'EASI-75 response', 'Eczema Area and Severity Index scores (EASI-75', 'conjunctivitis rates', 'Efficacy and Safety', 'EASI score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}]",422.0,0.348949,More patients taking dupilumab weekly or every 2 weeks (116 of 162 [71.6%]; P < .001 vs placebo) maintained EASI-75 response than those taking dupilumab every 4 weeks (49 of 84 [58.3%]) or every 8 weeks (45 of 82 [54.9%]) or those taking placebo (24 of 79 [30.4%]).,"[{'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Worm', 'Affiliation': 'Division of Allergy and Immunology, Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': 'Department of Dermatology, Nice University Hospital, Nice, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Beissert', 'Affiliation': 'Klinik und Poliklinik für Dermatologie, Universitätsklinikum, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kawashima', 'Affiliation': ""Tokyo Women's Medical University, School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferrándiz', 'Affiliation': 'Servicio de Dermatología, Hospital Universitario Germans Trias i Pujol, Universidad Autónoma de Barcelona, Badalona, Spain.'}, {'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Smith', 'Affiliation': ""St John's Institute of Dermatology, Guys and St Thomas' Foundation Trust, King's College, London, United Kingdom.""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Kuo-Chen', 'Initials': 'KC', 'LastName': 'Chan', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Bolanle', 'Initials': 'B', 'LastName': 'Akinlade', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hultsch', 'Affiliation': 'Sanofi Genzyme, Cambridge, Massachusetts.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Staudinger', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Davis', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Rajadhyaksha', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Stahl', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}]",JAMA dermatology,['10.1001/jamadermatol.2019.3617']
3387,32179568,"Treatment of severe acute malnutrition with oat or standard ready-to-use therapeutic food: a triple-blind, randomised controlled clinical trial.","OBJECTIVE
We hypothesised that an alternative RUTF (ready-to-use therapeutic food) made with oats (oat-RUTF) would be non-inferior to standard RUTF (s-RUTF).
DESIGN
This was a randomised, triple-blind, controlled, clinical non-inferiority trial comparing oat-RUTF to s-RUTF in rural Sierra Leone. Children aged 6-59 months with severe acute malnutrition (SAM) were randomised to oat-RUTF or s-RUTF. s-RUTF was composed of milk powder, sugar, peanut paste and vegetable oil, with a hydrogenated vegetable oil additive. Oat-RUTF contained oats and no hydrogenated vegetable oil additives. The primary outcome was graduation, an increase in anthropometric measurements such that the child was not acutely malnourished. Secondary outcomes were rates of growth, time to graduation and presence of adverse events. Intention to treat analyses was used.
RESULTS
Of the 1406 children were enrolled, graduation was attained in 404/721 (56%) children receiving oat-RUTF and 311/685 (45%) receiving s-RUTF (difference 10.6%, 95% CI 5.4% to 15.8%). Death, hospitalisation or remaining with SAM was seen in 87/721 (12%) receiving oat-RUTF and in 125/685 (18%) receiving s-RUTF (difference 6.2%, 95% CI 2.3 to 10.0, p=0.001). Time to graduation was less for children receiving oat RUTF; 3.9±1.8 versus 4.5±1.8 visits, respectively (p<0.001). Rates of weight in the oat-RUTF group were greater than in the s-RUTF group; 3.4±2.7 versus 2.5±2.3 g/kg/d, p<0.001.
CONCLUSION
Oat-RUTF is superior to s-RUTF in the treatment of SAM in Sierra Leone. We speculate that might be because of beneficial bioactive components or the absence of hydrogenated vegetable oil in oat-RUTF.
TRIAL REGISTRATION NUMBER
NCT03407326.",2020,"Rates of weight in the oat-RUTF group were greater than in the s-RUTF group; 3.4±2.7 versus 2.5±2.3 g/kg/d, p<0.001.
CONCLUSION
","['Children aged 6-59 months with severe acute malnutrition (SAM', 'rural Sierra Leone', '1406 children were enrolled, graduation was attained in 404/721 (56']","['oat-RUTF to s-RUTF', 'oat-RUTF or s-RUTF', 'Oat-RUTF', 'milk powder, sugar, peanut paste and vegetable oil, with a hydrogenated vegetable oil additive', 'Oat-RUTF contained oats and no hydrogenated vegetable oil additives', 'oat-RUTF']","['Rates of weight', 'rates of growth, time to graduation and presence of adverse events', 'Death, hospitalisation or remaining with SAM']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0037063', 'cui_str': 'Republic of Sierra Leone'}]","[{'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0042438', 'cui_str': 'Vegetable Oils'}, {'cui': 'C0982446', 'cui_str': 'Hydrogenated Vegetable Oil'}, {'cui': 'C0442796', 'cui_str': 'Additive (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}]",1406.0,0.323655,"Rates of weight in the oat-RUTF group were greater than in the s-RUTF group; 3.4±2.7 versus 2.5±2.3 g/kg/d, p<0.001.
CONCLUSION
","[{'ForeName': 'David Taylor', 'Initials': 'DT', 'LastName': 'Hendrixson', 'Affiliation': 'Pediatrics, Washington University in Saint Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Godbout', 'Affiliation': 'Pediatrics, Washington University in Saint Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Los', 'Affiliation': 'Pediatrics, Washington University in Saint Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Callaghan-Gillespie', 'Affiliation': 'Pediatrics, Washington University in Saint Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Mui', 'Affiliation': 'Pediatrics, Washington University in Saint Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Wegner', 'Affiliation': 'Pediatrics, Washington University in Saint Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Bryant', 'Affiliation': 'MANA Nutrition, Fitzgerald, Georgia, USA.'}, {'ForeName': 'Aminata', 'Initials': 'A', 'LastName': 'Koroma', 'Affiliation': 'Directorate of Nutrition, Sierra Leone Ministry of Health and Sanitation, Freetown, Sierra Leone.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Manary', 'Affiliation': 'Pediatrics, Washington University School of Medicine, St Louis, Missouri, USA manary@kids.wustl.edu.'}]",Gut,['10.1136/gutjnl-2020-320769']
3388,32169887,"Dietary Advanced Glycation End-products (AGE) and Risk of Breast Cancer in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO).","Advanced glycation end-products (AGEs) are implicated in the pathogenesis of several chronic diseases including cancer. AGEs are produced endogenously but can also be consumed from foods. AGE formation in food is accelerated during cooking at high temperatures. Certain high fat or highly processed foods have high AGE values. The objective of the study was to assign and quantify N ϵ -carboxymethyl-lysine (CML)-AGE content in food and investigate the association between dietary AGE intake and breast cancer risk in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. The study included women enrolled in the intervention arm who were cancer-free at baseline and completed a baseline questionnaire and food frequency questionnaire (DQX). CML-AGE values were assigned and quantified to foods in the DQX using a published AGE database. Cox proportional hazards models were used to estimate the hazard ratios (HR) and 95% confidence intervals (CI) of breast cancer among all women, and stratified by race/ethnicity, invasiveness of disease, and hormone receptor status. After a median 11.5 years of follow-up, 1,592 women were diagnosed with breast cancer. Higher CML-AGE intake was associated with increased risk of breast cancer among all women (HR Q5VSQ1 , 1.30; 95% CI, 1.04-1.62; P trend = 0.04) and in non-Hispanic white women (HR T3VST1 , 1.21; 95% CI, 1.02-1.44). Increased CML-AGE intake was associated with increased risk of in situ (HR T3VST1 , 1.49; 95% CI, 1.11-2.01) and hormone receptor-positive (HR T3VST1 , 1.24; 95% CI, 1.01-1.53) breast cancers. In conclusion, high intake of dietary AGE may contribute to increased breast cancer.",2020,"Higher CML-AGE intake was associated with increased risk of breast cancer among all women (HRQ5 VS Q1:1.30, 95% CI: 1.04-1.62; P-trend: 0.04) and in non-Hispanic white women (HRT3 VS T1: 1.21, 95% CI: 1.02-1.44).","['1,592 women were diagnosed with breast cancer', 'women enrolled in the intervention arm who were cancer-free at baseline and completed a']",[],"['hormone receptor positive (HRT3 VS T1', 'Increased CML-AGE intake', 'risk of breast cancer', 'baseline questionnaire and food frequency questionnaire (DQX']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",[],"[{'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",1592.0,0.0530889,"Higher CML-AGE intake was associated with increased risk of breast cancer among all women (HRQ5 VS Q1:1.30, 95% CI: 1.04-1.62; P-trend: 0.04) and in non-Hispanic white women (HRT3 VS T1: 1.21, 95% CI: 1.02-1.44).","[{'ForeName': 'Omonefe O', 'Initials': 'OO', 'LastName': 'Omofuma', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Turner', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Lindsay L', 'Initials': 'LL', 'LastName': 'Peterson', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Anwar T', 'Initials': 'AT', 'LastName': 'Merchant', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Steck', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina. stecks@mailbox.sc.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0457']
3389,32131745,Effectiveness of a village-based intervention for depression in community-dwelling older adults: a randomised feasibility study.,"BACKGROUND
Although a focus on late-life depression may help preventing suicide in older adults, many older people, especially those living in rural areas, have relatively low accessibility to treatment. This study examined the feasibility and effectiveness of a village-based intervention for depression targeting older adults living in rural areas.
METHODS
A community-based randomised pilot trial was performed in two small rural villages in South Korea. Two villages were randomly selected and assigned to the intervention or active control group; all older adults living in the two villages (n = 451) were included in the intervention program or received standard Community Mental Health Service (CMHS) care, and the effectiveness of the program was examined using representative samples from both groups (n = 160). The 12-week intervention included case management according to individual risk level and group-based activities. Healthy residents living in the intervention village who played major roles in monitoring at-risk older individuals were supervised by CMHS staff. The score on the Korean version of the Geriatric Depression Scale-Short Form (SGDS-K) was the primary outcome, while social network, functional status, and global cognitive function were secondary outcomes. Linear mixed models including the factors of intervention group, time, and their interaction were used to examine group differences in changes in primary and secondary outcomes from baseline to follow up.
RESULTS
Overall, there was no significant group × time interaction with respect to the SGDS-K score, but older individuals with more depressive symptoms at baseline (SGDS-K ≥ 6) tended to have a lower likelihood of progressing to severe depression at post-intervention. The social network was strengthened in the intervention group, and there was a significant group × time interaction (F[df1, df2], 5.29 [1, 153], p = 0.023).
CONCLUSION
This study examined a 12-week village-based intervention for late-life depression in which the CMHS helped village-dwellers deal with late-life depression in their communities. Although the intervention improved social interactions among older adults, it did not reduce depressive symptoms. Further studies including more rural villages and long-term follow up are needed to confirm the effectiveness of this prevention program.
TRIAL REGISTRATION
NCT04013165 (date: 9 July 2019, retrospectively registered).",2020,"Two villages were randomly selected and assigned to the intervention or active control group; all older adults living in the two villages (n = 451) were included in the intervention program or received standard Community Mental Health Service (CMHS) care, and the effectiveness of the program was examined using representative samples from both groups (n = 160).","['late-life depression in which the CMHS helped village-dwellers deal with late-life depression in their communities', 'community-dwelling older adults', 'Healthy residents living in the intervention village who played major roles in monitoring at-risk older individuals', 'older adults', 'depression targeting older adults living in rural areas', 'group; all older adults living in the two villages (n\u2009=\u2009451) were included in the', 'two small rural villages in South Korea']","['intervention program or received standard Community Mental Health Service (CMHS) care', 'intervention or active control', 'village-based intervention']","['social network, functional status, and global cognitive function', 'Korean version of the Geriatric Depression Scale-Short Form (SGDS-K', 'SGDS-K score', 'depressive symptoms', 'social interactions', 'social network']","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009475', 'cui_str': 'Community Mental Health Services'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C2919619', 'cui_str': 'Geriatric depression scale short form'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",2.0,0.0317512,"Two villages were randomly selected and assigned to the intervention or active control group; all older adults living in the two villages (n = 451) were included in the intervention program or received standard Community Mental Health Service (CMHS) care, and the effectiveness of the program was examined using representative samples from both groups (n = 160).","[{'ForeName': 'In Mok', 'Initials': 'IM', 'LastName': 'Oh', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Seoul National University College of Medicine and Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea.'}, {'ForeName': 'Maeng Je', 'Initials': 'MJ', 'LastName': 'Cho', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Seoul National University College of Medicine and Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea.'}, {'ForeName': 'Bong-Jin', 'Initials': 'BJ', 'LastName': 'Hahm', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Seoul National University College of Medicine and Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea.'}, {'ForeName': 'Byung-Soo', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, School of Medicine, Kyungpook National University, 80, Daehak-ro, Buk-gu, Daegu, Republic of Korea.'}, {'ForeName': 'Jee Hoon', 'Initials': 'JH', 'LastName': 'Sohn', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Seoul National University College of Medicine and Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea.'}, {'ForeName': 'Hye Won', 'Initials': 'HW', 'LastName': 'Suk', 'Affiliation': 'Department of Psychology, Sogang University, 35, Baekbeom-ro, Mapo-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Bu Young', 'Initials': 'BY', 'LastName': 'Jung', 'Affiliation': 'Yeoncheon Commnity Mental Health Center, 95, Eundaeseong-ro, Jeongok-eup, Yeoncheon-gun, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Hye Jung', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Yeoncheon Commnity Mental Health Center, 95, Eundaeseong-ro, Jeongok-eup, Yeoncheon-gun, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Hyeon A', 'Initials': 'HA', 'LastName': 'Kim', 'Affiliation': 'Yeoncheon Commnity Mental Health Center, 95, Eundaeseong-ro, Jeongok-eup, Yeoncheon-gun, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Ki Bok', 'Initials': 'KB', 'LastName': 'Choi', 'Affiliation': 'Yeoncheon Commnity Mental Health Center, 95, Eundaeseong-ro, Jeongok-eup, Yeoncheon-gun, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Da Hye', 'Initials': 'DH', 'LastName': 'You', 'Affiliation': 'Yeoncheon Commnity Mental Health Center, 95, Eundaeseong-ro, Jeongok-eup, Yeoncheon-gun, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Ah Reum', 'Initials': 'AR', 'LastName': 'Lim', 'Affiliation': 'Yeoncheon Commnity Mental Health Center, 95, Eundaeseong-ro, Jeongok-eup, Yeoncheon-gun, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'In Ok', 'Initials': 'IO', 'LastName': 'Park', 'Affiliation': 'Yeoncheon Commnity Mental Health Center, 95, Eundaeseong-ro, Jeongok-eup, Yeoncheon-gun, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Jeung Hyuck', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Yeoncheon Commnity Mental Health Center, 95, Eundaeseong-ro, Jeongok-eup, Yeoncheon-gun, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Hee', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Yeoncheon Commnity Mental Health Center, 95, Eundaeseong-ro, Jeongok-eup, Yeoncheon-gun, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Yeoncheon Commnity Mental Health Center, 95, Eundaeseong-ro, Jeongok-eup, Yeoncheon-gun, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Mi Ra', 'Initials': 'MR', 'LastName': 'Kim', 'Affiliation': 'Yeoncheon Commnity Mental Health Center, 95, Eundaeseong-ro, Jeongok-eup, Yeoncheon-gun, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Jee Eun', 'Initials': 'JE', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Seoul National University College of Medicine and Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea. parkim80@snu.ac.kr.'}]",BMC geriatrics,['10.1186/s12877-020-1495-2']
3390,31330464,Alcohol demand moderates brief motivational intervention outcomes in underage young adult drinkers.,"INTRODUCTION
The Alcohol Purchase Task (APT), a behavioral economic measure of alcohol's reinforcing value (demand), has been used to predict the effects of Brief Motivational Intervention (BMI) on alcohol use outcomes. However, it is not known whether BMI may be more or less efficacious, relative to control, among those with different levels of alcohol demand prior to treatment.
METHODS
Non college-attending young adults (N = 150) reporting past-month heavy drinking were randomized to a single in-person session of BMI or a relaxation training control (REL). The BMI included delivery of personalized feedback and focused on developing discrepancy between the young adults' goals and their current pattern of alcohol use. At baseline, participants completed assessments of alcohol use and the APT. Drinking levels were re-assessed at 6 weeks and 3 months post-intervention. Demand indices derived from the APT were examined as moderators of treatment effects on follow-up drinking after covarying for baseline alcohol use.
RESULTS
Two of four APT demand indices - intensity and O max - moderated treatment outcomes. Relative to REL, BMI led to greater reductions in total number of drinks consumed and drinks per drinking day among participants with higher baseline alcohol demand. This association was not observed among participants with lower levels of alcohol demand.
CONCLUSIONS
These results demonstrate that BMI may be particularly beneficial for those with a high reinforcing value of alcohol. The mechanism for this effect is unclear, and determining the process by which BMI confers increased benefit for these individuals is a fruitful area for future work.",2019,"Relative to REL, BMI led to greater reductions in total number of drinks consumed and drinks per drinking day among participants with higher baseline alcohol demand.","['underage young adult drinkers', 'participants with lower levels of alcohol demand', 'Non college-attending young adults (N\u202f=\u202f150) reporting past-month heavy drinking']","['single in-person session of BMI or a relaxation training control (REL', 'Alcohol demand moderates brief motivational intervention', 'Brief Motivational Intervention (BMI']","['indices - intensity and O max', 'Drinking levels']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.013402,"Relative to REL, BMI led to greater reductions in total number of drinks consumed and drinks per drinking day among participants with higher baseline alcohol demand.","[{'ForeName': 'Rachel N', 'Initials': 'RN', 'LastName': 'Cassidy', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, United States. Electronic address: Rachel_Cassidy@Brown.edu.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Bernstein', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, United States.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Magill', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacKillop', 'Affiliation': ""Peter Boris Centre for Addictions Research, McMaster University & St. Joseph's Healthcare Hamilton, United States.""}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychology, University of Memphis, United States.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Center for Alcohol & Addiction Studies, Brown University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.106044']
3391,32102557,Nutritional outcomes after radiotherapy target volume reduction for nasopharyngeal cancer: a Phase III trial.,"Aim: This study aimed to assess the nutritional status of patients with locoregionally advanced nasopharyngeal cancer, for whom intensity-modulated radiotherapy (IMRT) was planned using their pre- or post-induction chemotherapy (IC) nasopharyngeal gross tumor volume. Materials & methods: 212 cases of stage III-IVb nasopharyngeal cancer were randomized into groups A (n = 97) and B (n = 115). IMRT was planned for groups A and B using pre-IC and post-IC images, respectively. Results: There was a significant decrease in the nutritional parameters of group B compared with those of group A during radiotherapy. Multivariate analysis indicated that the T stage and nasopharyngeal gross tumor volume IMRT-planning protocol were prognostic factors of poor nutritional status. Conclusion: Decreasing the IMRT target volume through IC can improve nutritional status.",2020,Multivariate analysis indicated that the T stage and nasopharyngeal gross tumor volume IMRT-planning protocol were prognostic factors of poor nutritional status. ,"['Two-hundred twelve cases of stage III-IVb nasopharyngeal cancer', 'nasopharyngeal cancer', 'patients with locoregionally advanced nasopharyngeal cancer, for whom intensity-modulated radiotherapy (IMRT) was planned using their pre- or post-induction chemotherapy (IC) nasopharyngeal gross tumor volume']","['radiotherapy', 'IMRT']",['nutritional parameters'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0238301', 'cui_str': 'Cancer of Nasopharynx'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0475645', 'cui_str': 'Gross tumor volume (observable entity)'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0194936,Multivariate analysis indicated that the T stage and nasopharyngeal gross tumor volume IMRT-planning protocol were prognostic factors of poor nutritional status. ,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xiang', 'Affiliation': 'Institute of Drug Clinical Trial, Department of Thoracic Oncology of Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Jin-Feng', 'Initials': 'JF', 'LastName': 'Rong', 'Affiliation': ""Department of Oncology, Second People's Hospital of Yibin, Yibin, Sichuan, PR China.""}, {'ForeName': 'Hao-Wen', 'Initials': 'HW', 'LastName': 'Pang', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, PR China.'}, {'ForeName': 'Huai-Lin', 'Initials': 'HL', 'LastName': 'He', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, PR China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Institute of Drug Clinical Trial, Department of Thoracic Oncology of Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Jing-Bo', 'Initials': 'JB', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, PR China.'}, {'ForeName': 'Yong-Sheng', 'Initials': 'YS', 'LastName': 'Wang', 'Affiliation': 'Institute of Drug Clinical Trial, Department of Thoracic Oncology of Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}]","Future oncology (London, England)",['10.2217/fon-2019-0785']
3392,31771385,Child Caries Management: A Randomized Controlled Trial in Dental Practice.,"This multicenter 3-arm, parallel-group, patient-randomized controlled trial compared clinical effectiveness of 3 treatment strategies over 3 y for managing dental caries in primary teeth in UK primary dental care. Participants aged 3 to 7 y with at least 1 primary molar with dentinal carious lesion were randomized across 3 arms (1:1:1 via centrally administered system with variable-length random permuted blocks): C+P, conventional carious lesion management (complete carious tooth tissue removal and restoration placement) with prevention; B+P, biological management (sealing in carious tooth tissue restoratively) with prevention; and PA, prevention alone (diet, plaque removal, fluorides, and fissure sealants). Parents, children, and dentists were not blind to allocated arm. Co-primary outcomes were 1) the proportion of participants with at least 1 episode of dental pain and/or infection and 2) the number of episodes of dental pain and/or infection during follow-up (minimum, 23 mo). In sum, 1,144 participants were randomized (C+P, n = 386; B+P, n = 381; PA, n = 377) by 72 general dental practitioners, of whom 1,058 (C+P, n = 352; B+P, n = 352; PA, n = 354) attended at least 1 study visit and were included in the primary analysis. The median follow-up was 33.8 mo (interquartile range, 23.8 to 36.7). Proportions of participants with at least 1 episode of dental pain and/or infection were as follows: C+P, 42%; B+P, 40%; PA, 45%. There was no evidence of a difference in incidence of dental pain and/or infection when B+P (adjusted risk difference [97.5% CI]: -2% [-10% to 6%]) or PA (4% [-4% to 12%]) was compared with C+P. The mean (SD) number of episodes of dental pain and/or infection were as follows: C+P, 0.62 (0.95); B+P, 0.58 (0.87); and PA, 0.72 (0.98). Superiority could not be concluded for number of episodes between B+P (adjusted incident rate ratio (97.5% CI): 0.95 [0.75 to 1.21]) or PA (1.18 [0.94 to 1.48]) and C+P. In conclusion, there was no evidence of a difference among the 3 treatment approaches for incidence or number of episodes of dental pain and/or infection experienced by these participants with high caries risk and established disease (trial registration: ISRCTN77044005).",2020,There was no evidence of a difference in incidence of dental pain and/or infection when B+P (adjusted risk difference [97.5% CI]: -2% [-10% to 6%]) or PA (4% [-4% to 12%]) was compared with C+P.,"['1,144 participants were randomized (C+P, n = 386; B+P, n = 381; PA, n = 377) by 72 general dental practitioners, of whom 1,058 (C+P, n = 352; B+P, n = 352; PA, n = 354) attended at least 1 study visit and were included in the primary analysis', 'Participants aged 3 to 7 y with at least 1 primary molar with dentinal carious lesion', 'Child Caries Management', '3 y for managing dental caries in primary teeth in UK primary dental care', 'participants with at least 1 episode of dental pain and/or infection were as follows']","['centrally administered system with variable-length random permuted blocks): C+P, conventional carious lesion management (complete carious tooth tissue removal and restoration placement) with prevention; B+P, biological management (sealing in carious tooth tissue restoratively) with prevention; and PA, prevention alone (diet, plaque removal, fluorides, and fissure sealants', 'C+P']","['incidence or number of episodes of dental pain and/or infection', 'incidence of dental pain and/or infection', 'proportion of participants with at least 1 episode of dental pain and/or infection and 2) the number of episodes of dental pain and/or infection', 'mean (SD) number of episodes of dental pain and/or infection']","[{'cui': 'C4708787', 'cui_str': '381 (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}, {'cui': 'C0011331', 'cui_str': 'Dental Care'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0016168', 'cui_str': 'Fissure Sealants'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",1144.0,0.369859,There was no evidence of a difference in incidence of dental pain and/or infection when B+P (adjusted risk difference [97.5% CI]: -2% [-10% to 6%]) or PA (4% [-4% to 12%]) was compared with C+P.,"[{'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Innes', 'Affiliation': 'School of Dentistry, University of Dundee, Dundee, UK.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Clarkson', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'G V A', 'Initials': 'GVA', 'LastName': 'Douglas', 'Affiliation': 'School of Dentistry, University of Leeds, Leeds, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ryan', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Homer', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Marshman', 'Affiliation': 'School of Clinical Dentistry, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Robertson', 'Affiliation': 'School of Dentistry, University of Dundee, Dundee, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abouhajar', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Holmes', 'Affiliation': 'School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Chadwick', 'Affiliation': 'School of Dentistry, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Deery', 'Affiliation': 'School of Clinical Dentistry, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Wong', 'Affiliation': 'Institute of Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maguire', 'Affiliation': 'School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK.'}]",Journal of dental research,['10.1177/0022034519888882']
3393,31154811,"Implementation and impact of a technology-based HIV risk-reduction intervention among Thai men who have sex with men using ""Vialogues"": a randomized controlled trial.","We conducted a randomized control trial to evaluate the impact of a novel technology-based intervention on HIV risks and condom use behaviors among Thai men who have sex with men (MSM). Between April 2016 and August 2017, participants aged 18 years and above, and having engaged in unprotected sex in past six months were randomly assigned to control and intervention arm, and received HIV testing at baseline, month 6 and 12. Intervention arm participants engaged in 12-monthly HIV/STI prevention educational sessions delivered via Vialogues.com. Of 76 MSM enrolled, 37 were randomized to intervention and 39 to control arm. Median age was 28 (IQR 24-32) years. Thirty-three (89.2%) intervention arm participants completed all 12-monthly Vialogues sessions. At month 12, intervention arm had higher retention rate ( p = 0.029) and higher median percentage of condom use for anal intercourse ( p = 0.023) versus control arm. Over the 12-month period, intervention arm reported significant reduction in self-perceived HIV risk ( p = 0.001), popper usage ( p = 0.002), median number of sexual partners ( p = 0.003), and increased median condom use percentage ( p = 0.006). Our study highlights that ""Vialogues"" intervention significantly reduced number of sexual partners and condomless anal intercourse rates among Thai MSM, and has positive implications for reducing epidemic among key populations.",2020,"At month 12, intervention arm had higher retention rate ( p = 0.029) and higher median percentage of condom use for anal intercourse ( p = 0.023) versus control arm.","['Between April 2016 and August 2017, participants aged 18 years and above, and having engaged in unprotected sex in past six months', 'Thai men who have sex with men using ""Vialogues', 'Thai men who have sex with men (MSM', 'Median age was 28 (IQR 24-32) years']","['novel technology-based intervention', 'Intervention arm participants engaged in 12-monthly HIV/STI prevention educational sessions delivered via Vialogues.com', 'Vialogues"" intervention', 'technology-based HIV risk-reduction intervention']","['self-perceived HIV risk', 'HIV risks and condom use behaviors', 'sexual partners and condomless anal intercourse rates', 'higher retention rate', 'median percentage of condom use for anal intercourse', 'median number of sexual partners', 'median condom use percentage']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0556482', 'cui_str': 'Unsafe Sex'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0556463', 'cui_str': 'Number of sexual partners (observable entity)'}]",76.0,0.0911471,"At month 12, intervention arm had higher retention rate ( p = 0.029) and higher median percentage of condom use for anal intercourse ( p = 0.023) versus control arm.","[{'ForeName': 'Tarandeep', 'Initials': 'T', 'LastName': 'Anand', 'Affiliation': 'PREVENTION, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Chattiya', 'Initials': 'C', 'LastName': 'Nitpolprasert', 'Affiliation': 'PREVENTION, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Jureeporn', 'Initials': 'J', 'LastName': 'Jantarapakde', 'Affiliation': 'PREVENTION, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Ratchadaporn', 'Initials': 'R', 'LastName': 'Meksena', 'Affiliation': 'PREVENTION, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Sangusa', 'Initials': 'S', 'LastName': 'Phomthong', 'Affiliation': 'PREVENTION, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Petchfa', 'Initials': 'P', 'LastName': 'Phoseeta', 'Affiliation': 'PREVENTION, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Praphan', 'Initials': 'P', 'LastName': 'Phanuphak', 'Affiliation': 'PREVENTION, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Nittaya', 'Initials': 'N', 'LastName': 'Phanuphak', 'Affiliation': 'PREVENTION, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}]",AIDS care,['10.1080/09540121.2019.1622638']
3394,32150128,"The Titanium-Coated PEEK Cage Maintains Better Bone Fusion with the Endplate than the PEEK Cage 6 Months After PLIF Surgery-A Multicenter, Prospective, Randomized Study.","STUDY DESIGN
A multicenter, randomized, open-label, parallel-group trial.
OBJECTIVE
To investigate interbody bone fusion rates in titanium-coated polyetheretherketone (TiPEEK) and polyetheretherketone (PEEK) cages after posterior lumbar interbody fusion (PLIF) surgery.
SUMMARY OF BACKGROUND DATA
Previous clinical studies have not revealed any significant difference in bone fusion rates between TiPEEK and PEEK cages.
METHODS
During one-level PLIF surgery, 149 patients (84 men, 65 women, mean age 67 years) were randomly allocated to use either a TiPEEK cage (n = 69) or PEEK cage (n = 80). Blinded radiographic evaluations were performed using computed tomography (CT) and assessed by modified intention-to-treat (mITT) analysis in 149 cases and per-protocol (PP) analysis in 143 cases who were followed for 12 months. Clinical outcomes were assessed using the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and the Oswestry Disability Index (ODI).
RESULTS
The interbody union rate at 12 months after surgery was 45% owing to a very strict definition of bone fusion. The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted mITT analysis and were significantly higher at 6 months in the unadjusted PP analysis. Binary logistic regression analysis adjusted for sex, age, body mass index, bone mineral density, and surgical level showed that using a TiPEEK cage (odds ratio, 2.27; 95% confidence interval: 1.09-4.74; p = 0.03) was independently associated with bone fusion at 6 months after surgery. JOABPEQ and ODI results improved postoperatively in both groups.
CONCLUSIONS
Using the TiPEEK cage for PLIF enabled the maintenance of better bone fusion to the endplate than using the PEEK cage at 6 months after the surgery. Our findings suggest the possibility of an earlier return to rigorous work or sports by the use of TiPEEK cage.
LEVEL OF EVIDENCE
1.",2020,The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted mITT analysis and were significantly higher at 6 months in the unadjusted PP analysis.,"['149 patients (84 men, 65 women, mean age 67 years']","['titanium-coated polyetheretherketone (TiPEEK) and polyetheretherketone (PEEK) cages', 'computed tomography (CT) and assessed by modified intention-to-treat (mITT) analysis', 'TiPEEK cage (n\u200a=\u200a69) or PEEK cage']","['Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and the Oswestry Disability Index (ODI', 'rates of bone fusion', 'interbody union rate', 'bone fusion rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0337189', 'cui_str': 'Cage, device (physical object)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0185364', 'cui_str': 'Repair or plastic operation on bone'}]",149.0,0.0942351,The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted mITT analysis and were significantly higher at 6 months in the unadjusted PP analysis.,"[{'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ushirozako', 'Affiliation': 'Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Ebata', 'Initials': 'E', 'LastName': 'Shigeto', 'Affiliation': 'Department of Orthopedic Surgery, University of Yamanashi, Chuo, Yamanashi, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Ohba', 'Affiliation': 'Department of Orthopedic Surgery, University of Yamanashi, Chuo, Yamanashi, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Oba', 'Affiliation': 'Department of Orthopedic Surgery, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Mukaiyama', 'Affiliation': 'Department of Orthopedic Surgery, North Alps Medical Center Azumi Hospital, Kita Azumi, Nagano, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Shimizu', 'Affiliation': 'Department of Orthopedic Surgery, Narita memorial hospital, Aichi, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yamato', 'Affiliation': 'Department of Orthopedic Surgery and Division of Geriatric Musculoskeletal Health, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Ide', 'Affiliation': 'Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Shibata', 'Affiliation': 'Department of Community Health and Preventive Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Ojima', 'Affiliation': 'Department of Community Health and Preventive Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takahashi', 'Affiliation': 'Department of Orthopedic Surgery, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Haro', 'Affiliation': 'Department of Orthopedic Surgery, University of Yamanashi, Chuo, Yamanashi, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}]",Spine,['10.1097/BRS.0000000000003464']
3395,31310775,"Intravenous administration of ghrelin increases serum cortisol and aldosterone concentrations in heavy-drinking alcohol-dependent individuals: Results from a double-blind, placebo-controlled human laboratory study.","Increasing evidence supports the role of appetite-regulating hormones, including ghrelin, in alcohol use disorder (AUD). Effects of ghrelin administration on cortisol and aldosterone, two hormones known to influence the development and maintenance of AUD, have been observed in ghrelin-exposed tissues or cells, as well as rodents and healthy volunteers, however whether these effects replicate in individuals with AUD is unknown. Here, we tested the hypothesis that intravenous administration of ghrelin leads to increase in endogenous serum cortisol and aldosterone concentrations in alcohol-dependent, heavy drinking individuals, and that these changes may predict ghrelin-induced alcohol craving. This was a double-blind, placebo-controlled human laboratory study in non-treatment-seeking, heavy-drinking, alcohol-dependent individuals randomized to receive either placebo, 1 mcg/kg or 3 mcg/kg of intravenous ghrelin. Then, participants underwent a cue-reactivity procedure in a bar-like setting, which included exposure to both neutral (juice) and alcohol cues. Repeated blood samples were collected and used to measure endogenous cortisol and aldosterone serum concentrations, in response to exogenous ghrelin administration. Furthermore, cortisol and aldosterone serum concentrations were used to develop a model to predict the effect of exogenous ghrelin administration on alcohol craving. Intravenous ghrelin administration increased endogenous cortisol and aldosterone serum concentrations. While the effects on cortisol were greater than those on aldosterone, only the ghrelin-induced changes in aldosterone serum concentrations predicted craving. These findings provide initial evidence of ghrelin effects on glucocorticoids and mineralocorticoids in individuals with AUD, thereby providing additional information on the potential mechanisms by which the ghrelin system may play a role in alcohol craving and seeking in AUD.",2019,"While the effects on cortisol were greater than those on aldosterone, only the ghrelin-induced changes in aldosterone serum concentrations predicted craving.","['individuals with AUD', 'heavy-drinking alcohol-dependent individuals', 'healthy volunteers', 'non-treatment-seeking, heavy-drinking, alcohol-dependent individuals']","['placebo, 1 mcg/kg or 3 mcg/kg of intravenous ghrelin', 'cue-reactivity procedure in a bar-like setting, which included exposure to both neutral (juice) and alcohol cues', 'placebo', 'ghrelin']","['endogenous cortisol and aldosterone serum concentrations', 'alcohol craving', 'endogenous serum cortisol and aldosterone concentrations', 'serum cortisol and aldosterone concentrations']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1627892', 'cui_str': 'ng/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0729349', 'cui_str': 'Serum cortisol (substance)'}]",,0.0591482,"While the effects on cortisol were greater than those on aldosterone, only the ghrelin-induced changes in aldosterone serum concentrations predicted craving.","[{'ForeName': 'Carolina L', 'Initials': 'CL', 'LastName': 'Haass-Koffler', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA; Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, School of Public Health, Brown University, Providence, RI, USA; Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA. Electronic address: carolina_haass-koffler@brown.edu.'}, {'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Long', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, School of Public Health, Brown University, Providence, RI, USA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farokhnia', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA. Electronic address: mehdi.farokhnia@nih.gov.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Magill', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, School of Public Health, Brown University, Providence, RI, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Kenna', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Swift', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA; Veterans Affairs Medical Center, Providence, RI, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, School of Public Health, Brown University, Providence, RI, USA; Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA; Medication Development Program, National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Baltimore, MD, USA. Electronic address: lorenzo.leggio@nih.gov.'}]",Neuropharmacology,['10.1016/j.neuropharm.2019.107711']
3396,30496426,A population approach using cholesterol imputation to identify adults with high cardiovascular risk: a report from AHRQ's EvidenceNow initiative.,"Objective
Large practice networks have access to EHR data that can be used to drive important improvements in population health. However, missing data often limit improvement efforts. Our goal was to determine the proportion of patients in a cohort of small primary care practices who lacked cholesterol data to calculate ASCVD risk scores and then gauge the extent that imputation can accurately identify individuals already at high risk. 219 practices enrolled. Patients between the ages of 40 and 79 years qualified for risk calculation. For patients who lacked cholesterol data, we measured the effect of employing a conservative estimation strategy using a total cholesterol of 170 mg/dl and HDL-cholesterol of 50 mg/dl in the ASCVD risk equation to identify patients with ≥ 10%, 10-year ASCVD risk who were eligible for risk reduction interventions then compared this to a rigorous formal imputation methodology. 345 440 patients, average age 58 years, qualified for risk scores. 108 515 patients were missing cholesterol information. Using the ""good value"" estimation methodology, 40 565 had risk scores ≥ 10% compared to 43 205 using formal imputation. However, the latter strategy yielded a lower specificity and higher false positive rate. Estimates using either strategy achieved ASCVD risk stratification quickly and accurately identified high risk patients who could benefit from intervention.",2019,"However, the latter strategy yielded a lower specificity and higher false positive rate.","['adults with high cardiovascular risk', 'Patients between the ages of 40 and 79 years qualified for risk calculation', '219 practices enrolled', 'to identify patients with ≥ 10%, 10-year ASCVD risk who were eligible for risk reduction interventions', '108 515 patients were missing cholesterol information', '345 440 patients, average age 58 years, qualified for risk scores']",['total cholesterol of 170 mg/dl and HDL-cholesterol of 50 mg/dl in the ASCVD risk equation'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",[],,0.0277147,"However, the latter strategy yielded a lower specificity and higher false positive rate.","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Cykert', 'Affiliation': 'The Division of General Medicine and Clinical Epidemiology and the Cecil G. Sheps Center for Health Services Research, the University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Darren A', 'Initials': 'DA', 'LastName': 'DeWalt', 'Affiliation': 'The Division of General Medicine and Clinical Epidemiology and the Cecil G. Sheps Center for Health Services Research, the University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Weiner', 'Affiliation': 'Department of Global Public Health, School of Public Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pignone', 'Affiliation': 'The Department of Medicine, The Dell Medical School, University of Texas, Austin, Texas, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fine', 'Affiliation': 'The Department of Biostatistics, The Gillings School of Global Public Health, the University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jung In', 'Initials': 'JI', 'LastName': 'Kim', 'Affiliation': 'The Department of Biostatistics, The Gillings School of Global Public Health, the University of North Carolina, Chapel Hill, North Carolina, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocy151']
3397,31722952,Feasibility trial of a digital self-management intervention 'My Breathing Matters' to improve asthma-related quality of life for UK primary care patients with asthma.,"OBJECTIVE
To assess the feasibility of a randomised controlled trial (RCT) and acceptability of an asthma self-management digital intervention to improve asthma-specific quality of life in comparison with usual care.
DESIGN AND SETTING
A two-arm feasibility RCT conducted across seven general practices in Wessex, UK.
PARTICIPANTS
Primary care patients with asthma aged 18 years and over, with impaired asthma-specific quality of life and access to the internet.
INTERVENTIONS
'My Breathing Matters' (MBM) is a digital asthma self-management intervention designed using theory, evidence and person-based approaches to provide tailored support for both pharmacological and non-pharmacological management of asthma symptoms.
OUTCOMES
The primary outcome was the feasibility of the trial design, including recruitment, adherence and retention at follow-up (3 and 12 months). Secondary outcomes were the feasibility and effect sizes of specific trial measures including asthma-specific quality of life and asthma control.
RESULTS
Primary outcomes: 88 patients were recruited (target 80). At 3-month follow-up, two patients withdrew and six did not complete outcome measures. At 12 months, two withdrew and four did not complete outcome measures. 36/44 patients in the intervention group engaged with MBM (median of 4 logins, range 0-25, IQR 8). Consistent trends were observed to improvements in asthma-related patient-reported outcome measures.
CONCLUSIONS
This study demonstrated the feasibility and acceptability of a definitive RCT that is required to determine the clinical and cost-effectiveness of a digital asthma self-management intervention.
TRIAL REGISTRATION NUMBER
ISRCTN15698435.",2019,"36/44 patients in the intervention group engaged with MBM (median of 4 logins, range 0-25, IQR 8).","['Primary outcomes: 88 patients were recruited (target 80', 'UK primary care patients with asthma', 'A two-arm feasibility RCT conducted across seven general practices in Wessex, UK', 'Primary care patients with asthma aged 18 years and over, with impaired asthma-specific quality of life and access to the internet']","[""digital self-management intervention 'My Breathing Matters"", 'asthma self-management digital intervention', 'MBM', ""My Breathing Matters' (MBM""]","['feasibility of the trial design, including recruitment, adherence and retention', 'feasibility and effect sizes of specific trial measures including asthma-specific quality of life and asthma control', 'asthma-specific quality of life']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C1319219', 'cui_str': 'Asthma self-management'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0034380'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",88.0,0.102788,"36/44 patients in the intervention group engaged with MBM (median of 4 logins, range 0-25, IQR 8).","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Ainsworth', 'Affiliation': 'Department of Psychology, University of Bath, Bath, UK b.ainsworth@bath.ac.uk.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Greenwell', 'Affiliation': 'Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Stuart', 'Affiliation': 'Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Raftery', 'Affiliation': 'Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Mair', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bruton', 'Affiliation': 'School of Health Sciences, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032465']
3398,31874891,"Cluster randomised controlled trial to determine the effect of peer delivery HIV self-testing to support linkage to HIV prevention among young women in rural KwaZulu-Natal, South Africa: a study protocol.","INTRODUCTION
A cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa.
METHODS AND ANALYSIS
A three-arm cRCT started mid-March 2019, in 24 areas in rural KwaZulu-Natal. Twenty-four pairs of peer navigators working with ~12 000 young people aged 18 to 30 years over a period of 6 months were randomised to: (1) incentivised-peer-networks: peer-navigators recruited participants 'seeds' to distribute up to five HIVST packs and HIV prevention information to peers within their social networks. Seeds receive an incentive (20 Rand = US$1.5) for each respondent who contacts a peer-navigator for additional HIVST packs to distribute; (2) peer-navigator-distribution: peer-navigators distribute HIVST packs and information directly to young people; (3) standard of care: peer-navigators distribute referral slips and information. All arms promote sexual health information and provide barcoded clinic referral slips to facilitate linkage to HIV testing, prevention and care services. The primary outcome is the difference in linkage rate between arms, defined as the number of women (18 to 24 years) per peer-navigators month of outreach work (/pnm) who linked to clinic-based PrEP eligibility screening or started antiretroviral, based on HIV-status, within 90 days of receiving the clinic referral slip.
ETHICS AND DISSEMINATION
This study was approved by the Institutional Review Boards at the WHO, Switzerland (Protocol ID: STAR CRT, South Africa), London School of Hygiene and Tropical Medicine, UK (Reference: 15 990-1), University of KwaZulu-Natal (BFC311/18) and the KwaZulu-Natal Department of Health (Reference: KZ_201901_012), South Africa. The findings of this trial will be disseminated at local, regional and international meetings and through peer-reviewed publications.
TRIAL REGISTRATION NUMBER
NCT03751826; Pre-results.",2019,"A cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa.
","['Twenty-four pairs of peer navigators working with ~12 000 young people aged 18 to 30 years over a period of 6 months', 'young women in rural KwaZulu-Natal, South Africa', 'young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa']","['HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks', 'peer delivery HIV self-testing to support linkage to HIV prevention', 'peer-navigator for additional HIVST packs to distribute; (2) peer-navigator-distribution', ""incentivised-peer-networks: peer-navigators recruited participants 'seeds' to distribute up to five HIVST packs and HIV prevention information to peers within their social networks"", 'antiretroviral therapy and pre-exposure prophylaxis (PrEP']","['linkage rate', 'peer-navigators month of outreach work (/pnm) who linked to clinic-based PrEP eligibility screening or started antiretroviral, based on HIV-status']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0454729', 'cui_str': 'Natal (geographic location)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}]",24.0,0.104928,"A cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa.
","[{'ForeName': 'Oluwafemi Atanda', 'Initials': 'OA', 'LastName': 'Adeagbo', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Nondumiso', 'Initials': 'N', 'LastName': 'Mthiyane', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Herbst', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mee', 'Affiliation': 'Epidemiology and Public Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Neuman', 'Affiliation': 'Epidemiology and Public Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Jaco', 'Initials': 'J', 'LastName': 'Dreyer', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Natsayi', 'Initials': 'N', 'LastName': 'Chimbindi', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Smit', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Nonhlanhla', 'Initials': 'N', 'LastName': 'Okesola', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'Department of HIV/AIDS, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hatzold', 'Affiliation': 'Population Services International, Harare, Zimbabwe.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Cowan', 'Affiliation': 'International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Corbett', 'Affiliation': 'Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shahmanesh', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa m.shahmanesh@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-033435']
3399,31821109,NSABP B-47/NRG Oncology Phase III Randomized Trial Comparing Adjuvant Chemotherapy With or Without Trastuzumab in High-Risk Invasive Breast Cancer Negative for HER2 by FISH and With IHC 1+ or 2.,"PURPOSE
Adjuvant trastuzumab reduces invasive breast cancer (IBC) recurrence and risk for death in patients with HER2-amplified or overexpressing IBC. A subset of patients in the landmark trastuzumab adjuvant trials who originally tested HER2-positive but were HER2-negative by central HER2 testing appeared to possibly benefit from trastuzumab. The objective for the NSABP B-47 trial was to determine whether the addition of trastuzumab to adjuvant chemotherapy (CRx) would improve invasive disease-free survival (IDFS) in patients with HER2-negative breast cancer.
PATIENTS AND METHODS
A total of 3,270 women with high-risk primary IBC were randomly assigned to CRx with or without 1 year of trastuzumab. Eligibility criteria included immunohistochemistry (IHC) score 1+ or 2+ with fluorescence in situ hybridization ratio (FISH) < 2.0 or, if ratio was not performed, HER2 gene copy number < 4.0. CRx was either docetaxel plus cyclophosphamide or doxorubicin and cyclophosphamide followed by weekly paclitaxel for 12 weeks.
RESULTS
At a median follow-up of 46 months, the addition of trastuzumab to CRx did not improve IDFS (5-year IDFS: 89.8% with CRx plus trastuzumab [CRxT] v 89.2% with CRx alone; hazard ratio [HR], 0.98; 95% CI, 0.76 to 1.25; P = .85). These findings did not differ by level of HER2 IHC expression, lymph node involvement, or hormone-receptor status. For distant recurrence-free interval, 5-year estimates were 92.7% with CRxT compared with 93.6% for CRx alone (HR, 1.10; 95% CI, 0.81 to 1.50; P = .55) and for overall survival (OS) were 94.8% with CRxT and 96.3% in CRx alone (HR, 1.33; 95% CI, 0.90 to 1.95; P = .15). There were no unexpected toxicities from the addition of trastuzumab to CRx.
CONCLUSION
The addition of trastuzumab to CRx did not improve IDFS, distant recurrence-free interval, or OS in women with non-HER2-overexpressing IBC. Trastuzumab does not benefit women without IHC 3+ or FISH ratio-amplified breast cancer.",2020,"The addition of trastuzumab to CRx did not improve IDFS, distant recurrence-free interval, or OS in women with non-HER2-overexpressing IBC.","['3,270 women with high-risk primary IBC', 'patients with HER2-negative breast cancer', 'patients with HER2-amplified or overexpressing IBC']","['trastuzumab to adjuvant chemotherapy (CRx', 'Adjuvant Chemotherapy', 'CRx with or without 1 year of trastuzumab', 'CRx plus trastuzumab [CRxT', 'Trastuzumab', 'docetaxel plus cyclophosphamide or doxorubicin and cyclophosphamide', 'trastuzumab']","['IDFS, distant recurrence-free interval, or OS', 'invasive disease-free survival (IDFS', 'level of HER2 IHC expression, lymph node involvement, or hormone-receptor status', 'toxicities', 'IDFS ', 'distant recurrence-free interval, 5-year estimates', '5-year IDFS', 'overall survival (OS', 'invasive breast cancer (IBC) recurrence and risk for death']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0449443', 'cui_str': 'Receptor status (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",3270.0,0.231243,"The addition of trastuzumab to CRx did not improve IDFS, distant recurrence-free interval, or OS in women with non-HER2-overexpressing IBC.","[{'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Fehrenbacher', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Reena S', 'Initials': 'RS', 'LastName': 'Cecchini', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Costantino', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Atkins', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Crown', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Polikoff', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Boileau', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Provencher', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Stokoe', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Moore', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Robidoux', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Flynn', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Virginia F', 'Initials': 'VF', 'LastName': 'Borges', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Swain', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Soonmyung', 'Initials': 'S', 'LastName': 'Paik', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Eleftherios P', 'Initials': 'EP', 'LastName': 'Mamounas', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01455']
3400,30230402,"The effects of fish oil omega-3 fatty acid supplementation on mental health parameters and metabolic status of patients with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.","OBJECTIVE
This study was conducted to evaluate the effects of fish oil omega-3 fatty acid supplementation on mental health parameters and metabolic status of women with polycystic ovary syndrome (PCOS).
METHODS
This randomized double-blind, placebo-controlled trial was conducted on 60 women with PCOS, aged 18-40 years old. Participants were randomly assigned into two groups to receive either 2 × 1000 mg/day fish oil omega-3 fatty acid (n = 30) or placebo (n = 30) after lunch for 12 weeks. Metabolic profiles were quantified at baseline and after the 12-week intervention.
RESULTS
Compared with the placebo, omega-3 fatty acid intake led to a significant improvement in Beck Depression Inventory [β (difference in the mean outcomes measures between treatment groups after intervention) -1.05; 95% CI: -1.84, -0.26; p = .01], general health questionnaire (β -1.68; 95% CI: -3.12, -0.24; p = .02) and depression anxiety and stress scale (β -2.03; 95% CI: -3.60, -0.46; p = .01). Omega-3 fatty acid supplementation significantly decreased serum insulin levels (β -2.09 µIU/mL; 95% CI: -3.77, -0.41; p = .01), homeostasis model of assessment-insulin resistance (β -0.74; 95% CI: -1.13, -0.34; p < .001), total testosterone (β -0.23 ng/mL; 95% CI: -0.39, -0.06; p = .03) and hirsutism (β -0.75; 95% CI: -1.17, -0.33; p = .001), and significantly increased the quantitative insulin sensitivity check index (β 0.01; 95% CI: 0.003, 0.02; p = .008) compared with the placebo. Additionally, omega-3 fatty acid intake resulted in a significant decrease in high sensitivity C-reactive protein (β -1.46 mg/L; 95% CI: -2.16, -0.75; p < .001) and malondialdehyde (β -0.28 µmol/L; 95% CI: -0.52, -0.05; p = .03); also significant rises in plasma total glutathione (β 59.09 µmol/L; 95% CI: 7.07, 111.11; p = .02) was observed compared with the placebo. Omega-3 fatty acid supplementation did not change other metabolic parameters.
CONCLUSION
Overall, omega-3 fatty acid supplementation for 12 weeks to patients with PCOS had beneficial effects on mental health parameters, insulin metabolism, total testosterone, hirsutism and few inflammatory markers and oxidative stress.",2018,"Omega-3 fatty acid supplementation significantly decreased serum insulin levels (β -2.09 µIU/mL; 95% CI: -3.77,","['women with polycystic ovary syndrome (PCOS', 'patients with polycystic ovary syndrome', '60 women with PCOS, aged 18-40\u2009years old']","['placebo, omega-3 fatty acid intake', 'placebo', 'fish oil omega-3 fatty acid supplementation', 'Omega-3 fatty acid supplementation', 'omega-3 fatty acid intake', 'omega-3 fatty acid supplementation', '2\u2009×\u20091000\u2009mg/day fish oil omega-3 fatty acid (n\u2009=\u200930) or placebo']","['Beck Depression Inventory [β', 'homeostasis model of assessment-insulin resistance', 'plasma total glutathione', 'general health questionnaire', 'serum insulin levels', 'quantitative insulin sensitivity check index', 'total testosterone', 'Metabolic profiles', 'hirsutism', 'mental health parameters and metabolic status', 'high sensitivity C-reactive protein', 'mental health parameters, insulin metabolism, total testosterone, hirsutism and few inflammatory markers and oxidative stress', 'depression anxiety and stress scale']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556124', 'cui_str': 'N-3 fatty acid intake (observable entity)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire (assessment scale)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0019572', 'cui_str': 'Hirsutism'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}]",60.0,0.804909,"Omega-3 fatty acid supplementation significantly decreased serum insulin levels (β -2.09 µIU/mL; 95% CI: -3.77,","[{'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Amini', 'Affiliation': 'a Research Center for Biochemistry and Nutrition in Metabolic Diseases , Kashan University of Medical Sciences , Kashan , Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'a Research Center for Biochemistry and Nutrition in Metabolic Diseases , Kashan University of Medical Sciences , Kashan , Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Foroozanfard', 'Affiliation': 'b Department of Gynecology and Obstetrics, School of Medicine , Kashan University of Medical Sciences , Kashan , Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Vahedpoor', 'Affiliation': 'b Department of Gynecology and Obstetrics, School of Medicine , Kashan University of Medical Sciences , Kashan , Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'c Department of Addiction studies, School of Medical , Kashan University of Medical Sciences , Kashan , Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Taghizadeh', 'Affiliation': 'a Research Center for Biochemistry and Nutrition in Metabolic Diseases , Kashan University of Medical Sciences , Kashan , Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Karbassizadeh', 'Affiliation': 'd Barij Medicinal Plants Research Center , Kashan , Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'a Research Center for Biochemistry and Nutrition in Metabolic Diseases , Kashan University of Medical Sciences , Kashan , Iran.'}]",Journal of psychosomatic obstetrics and gynaecology,['10.1080/0167482X.2018.1508282']
3401,31393279,People With COPD Who Respond to Ground-Based Walking Training Are Characterized by Lower Pre-training Exercise Capacity and Better Lung Function and Have Greater Progression in Walking Training Distance.,"PURPOSE
To investigate the characteristics that distinguish responders from nonresponders to ground-based walking training (GBWT) in people with chronic obstructive pulmonary disease (COPD).
METHODS
An analysis was undertaken of data collected during a trial of GBWT in people with COPD. Responders to GBWT were defined in 2 ways: (1) improved time on the endurance shuttle walk test of ≥190 sec (criterion A); or (2) improved ability to walk, perceived by the participant to be at least ""moderate"" (criterion B). Differences in participant characteristics, pre-training exercise capacity, health-related quality of life, and the improvement in the distance walked during the training program were examined between responders and nonresponders.
RESULTS
Of the 95 participants randomized to GBWT (age 69 ± 8 yr, forced expiratory volume in 1 sec [FEV1] % predicted = 43% ± 15%), data were available for analysis on 78 and 73 patients by criterion A and criterion B, respectively. According to criterion A, 32 (41%) participants were responders. The odds of being a responder increased with increasing FEV1 % predicted (OR = 1.2; 95% CI, 1.0-1.5, for every 5% increase) and increased with decreasing pre-training incremental shuttle walk distance (OR = 1.4; 95% CI, 1.0-1.8, for every 50-m decrement). According to criterion B, 42 (58%) participants were responders. There were no differences in characteristics or pre-training measures between the responders and nonresponders. For both criteria, responders demonstrated greater change in the distance walked during the training program (P < .05).
CONCLUSION
Responders to GBWT had lower pre-training exercise capacity, had better lung function, and demonstrated greater change in the distance walked during the training program.",2019,"For both criteria, responders demonstrated greater change in the distance walked during the training program (P < .05).
","['people with COPD', '95 participants randomized to GBWT (age 69 ± 8 yr', 'People With COPD', 'people with chronic obstructive pulmonary disease (COPD']",['ground-based walking training (GBWT'],"['participant characteristics, pre-training exercise capacity, health-related quality of life, and the improvement in the distance walked during the training program', 'characteristics or pre-training measures', 'forced expiratory volume in 1 sec', 'lung function', 'time on the endurance shuttle walk test of ≥190 sec (criterion A); or (2) improved ability to walk, perceived by the participant to be at least ""moderate']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1960627', 'cui_str': 'Endurance Shuttle Walk Test'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]",95.0,0.0692328,"For both criteria, responders demonstrated greater change in the distance walked during the training program (P < .05).
","[{'ForeName': 'Jian Ping', 'Initials': 'JP', 'LastName': 'Ho', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, Western Australia, Australia (Ms Ho and Drs Jenkins, Eastwood, Cavalheri, and Hill); Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, Lidcombe, New South Wales, Australia (Drs Alison, Wootton, and McKeough); Sydney Local Health District, New South Wales, Australia (Drs Alison and Spencer); Physiotherapy Department, Singapore General Hospital, Singapore (Dr Ng); Chronic Disease Community Rehabilitation Service, Northern Sydney Local Health District, New South Wales, Australia (Dr Wootton); Institute for Respiratory Health (Drs Jenkins, Eastwood, Cavalheri, and Hill), Physiotherapy Department (Dr Jenkins), and Department of Pulmonary Physiology & Sleep Medicine (Drs Eastwood and Hillman), Sir Charles Gairdner Hospital, Western Australia, Australia; Centre for Sleep Science, School of Anatomy, Physiology & Human Biology, University of Western Australia, Western Australia, Australia (Dr Eastwood); and Department of Thoracic Medicine, Concord Hospital, Concord, New South Wales, Australia (Dr Jenkins).'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Alison', 'Affiliation': ''}, {'ForeName': 'L W Cindy', 'Initials': 'LWC', 'LastName': 'Ng', 'Affiliation': ''}, {'ForeName': 'Sally L', 'Initials': 'SL', 'LastName': 'Wootton', 'Affiliation': ''}, {'ForeName': 'Zoe J', 'Initials': 'ZJ', 'LastName': 'McKeough', 'Affiliation': ''}, {'ForeName': 'Sue C', 'Initials': 'SC', 'LastName': 'Jenkins', 'Affiliation': ''}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Eastwood', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Hillman', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Jenkins', 'Affiliation': ''}, {'ForeName': 'Lissa M', 'Initials': 'LM', 'LastName': 'Spencer', 'Affiliation': ''}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Cavalheri', 'Affiliation': ''}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000421']
3402,31611105,A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts.,"OBJECTIVE
Paclitaxel-coated balloons are used to reduce neointimal hyperplasia in native arteriovenous (AV) fistulas. However, no study specifically evaluated their effect on venous anastomotic stenosis of dialysis grafts. We aimed to compare the efficacy of angioplasty with drug-coated balloons (DCBs) and angioplasty with conventional balloons (CBs) for venous anastomotic stenosis in dysfunctional AV grafts.
METHODS
In this investigator-initiated, single-center, single-blinded, prospective randomized controlled trial, we randomly assigned 44 patients who had venous anastomotic stenosis to undergo angioplasty with DCBs (n = 22) or CBs (n = 22) from July 2015 to August 2018. Access function was observed per the hemodialysis center's protocols; ancillary angiographic follow-up was performed every 2 months for 1 year after the interventions. The primary end point was target lesion primary patency at 6 months. Secondary outcomes included anatomic and clinical success after angioplasty, circuit primary patency at 6 months and 1 year, and target lesion primary patency at 1 year.
RESULTS
At 6 months, target lesion primary patency in the DCB group was significantly greater than that in the CB group (41% vs 9%; hazard ratio [HR], 0.393; 95% confidence interval [CI], 0.194-0.795; P = .006), as was the primary patency of the entire access circuit (36% vs 9%; HR, 0.436; 95% CI, 0.218-0.870; P = .013). At 1 year, the target lesion primary patency in the DCB group remained greater than that in the CB group (23% vs 9%; HR, 0.477; 95% CI, 0.243-0.933; P = .019) but not the primary patency of the access circuit (14% vs 9%; HR, 0.552; 95% CI, 0.288-1.059; P = .056). No difference in anatomic or clinical success was observed; no major complications were noted.
CONCLUSIONS
Angioplasty with DCBs showed a modest improvement in primary patency of venous anastomotic stenosis and all dialysis AV grafts at 6 months. The short-term benefit was not durable to 1 year, and reinterventions were eventually needed.",2020,"No difference in anatomic or clinical success was observed; no major complications were noted.
","['venous anastomotic stenosis of dialysis arteriovenous grafts', '44 patients who had venous anastomotic stenosis to undergo angioplasty with DCBs (n\xa0= 22) or CBs (n\xa0= 22) from July 2015 to August 2018', 'native arteriovenous (AV) fistulas']","['Paclitaxel-coated balloons', 'drug-coated balloon angioplasty', 'angioplasty with drug-coated balloons (DCBs) and angioplasty with conventional balloons (CBs']","['neointimal hyperplasia', 'primary patency of venous anastomotic stenosis and all dialysis AV grafts', 'primary patency of the entire access circuit', 'target lesion primary patency', 'anatomic or clinical success', 'anatomic and clinical success after angioplasty, circuit primary patency at 6\xa0months and 1\xa0year, and target lesion primary patency at 1\xa0year', 'venous anastomotic stenosis of dialysis grafts', 'Access function']","[{'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0919938', 'cui_str': 'Anastomotic stenosis'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0729665', 'cui_str': 'Arteriovenous graft (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula (morphologic abnormality)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C4049446', 'cui_str': 'Neointimal hyperplasia'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0919938', 'cui_str': 'Anastomotic stenosis'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",44.0,0.109425,"No difference in anatomic or clinical success was observed; no major complications were noted.
","[{'ForeName': 'Min-Tsun', 'Initials': 'MT', 'LastName': 'Liao', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Cheng-Pin', 'Initials': 'CP', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Ting-Tse', 'Initials': 'TT', 'LastName': 'Lin', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chien-Boon', 'Initials': 'CB', 'LastName': 'Jong', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Tsung-Yan', 'Initials': 'TY', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan.'}, {'ForeName': 'Mu-Yang', 'Initials': 'MY', 'LastName': 'Hsieh', 'Affiliation': 'Division of Cardiology, Department of Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Mao-Shin', 'Initials': 'MS', 'LastName': 'Lin', 'Affiliation': 'College of Medicine, National Taiwan University, Taipei, Taiwan; Department of Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chu', 'Initials': 'WC', 'LastName': 'Chie', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital, Taipei, Taiwan; School of Public Health, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Cheng', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'College of Medicine, National Taiwan University, Taipei, Taiwan; Institute of Biomedical Engineering, National Tsing-Hua University, Hsinchu, Taiwan; Cardiovascular Center, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; Institute of Cellular and System Medicine, National Health Research Institute, Miaoli, Taiwan. Electronic address: chihchengwumd@gmail.com.'}]",Journal of vascular surgery,['10.1016/j.jvs.2019.07.090']
3403,31856749,Modified regional citrate anticoagulation is optimal for hemodialysis in patients at high risk of bleeding: a prospective randomized study of three anticoagulation strategies.,"BACKGROUND
Recommended regular saline flushing presents clinical ineffectiveness for hemodialysis (HD) patients at high risk of bleeding with heparin contraindication. Regional citrate anticoagulation (RCA) has previously been used with a Ca 2+ containing dialysate with prefiltered citrate in one arm (RCA-one). However, anticoagulation is not always achievable and up to 40% results in serious clotting in the venous expansion chamber. In this study, we have transferred one-quarter of the TSC from the prefiltered to the post filter based on RCA-one, which we have called RCA-two. The objective of this study was to compare the efficacy and safety of RCA-two with either saline flushing or RCA-one in HD patients with a high bleeding risk.
METHOD
In this investigator-initiated, multicenter, controlled, prospective, randomized clinical trial, 52 HD patients (77 sessions) were randomized to the RCA-2 and RCA-one group in part one of the trial, and 45 patients (64 sessions) were randomized to the RCA-2 and saline group in part two of the trial. Serious clotting events, adverse events and blood analyses were recorded.
RESULTS
Serious clotting events in the RCA-two group were significantly lower compared with the RCA-one and saline group (7.89% vs. 30.77%, P = 0.011; 3.03% vs. 54.84%, P < 0.001, respectively). The median circuit survival time was 240 min (IQR 240 to 240) in the RCA-two group, was significantly longer than 230 min (IQR 155 to 240, P < 0.001) in the RCA-one group and 210 min (IQR 135 to 240, P = 0.003) in the saline group. The majority of the AEs were hypotension, hypoglycemia and chest tightness, most of which were mild in intensity. Eight patients (20.51%) in the RCA-one group, 4 patients (12.90%) in the saline group and 10 patients (26.31%) in the RCA-two group, P > 0.05.
CONCLUSIONS
Our data demonstrated that the modified anticoagulation protocol was more effective and feasible during hemodialysis therapy for patients at high risk of bleeding.
TRIAL REGISTRATION
GDREC, GDREC2017250H. Registered February 2, 2018; retrospectively registered.",2019,"RESULTS
Serious clotting events in the RCA-two group were significantly lower compared with the RCA-one and saline group (7.89% vs. 30.77%, P = 0.011; 3.03% vs. 54.84%, P < 0.001, respectively).","['patients at high risk of bleeding', '52 HD patients (77 sessions', 'HD patients with a high bleeding risk', 'hemodialysis in patients at high risk of bleeding', 'hemodialysis (HD) patients at high risk of bleeding with heparin contraindication', 'group in part one of the trial, and 45 patients (64 sessions']","['RCA-2 and RCA-one', 'saline flushing or RCA', 'RCA', 'Regional citrate anticoagulation (RCA', 'Modified regional citrate anticoagulation', 'RCA-2 and saline']","['Serious clotting events, adverse events and blood analyses', 'efficacy and safety', 'hypotension, hypoglycemia and chest tightness', 'median circuit survival time', 'Serious clotting events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4039184', 'cui_str': 'High risk of hemorrhage'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0610301', 'cui_str': 'RCA II'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0376259', 'cui_str': 'Citrate'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005768'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0232292', 'cui_str': 'Tight chest (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",52.0,0.0396148,"RESULTS
Serious clotting events in the RCA-two group were significantly lower compared with the RCA-one and saline group (7.89% vs. 30.77%, P = 0.011; 3.03% vs. 54.84%, P < 0.001, respectively).","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Renwei', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Nephrology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Shuifu', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Nephrology, First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Qizhan', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Hemodialysis, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Xingbo', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Nephrology, First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Department of Hemodialysis, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yuchi', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Hemodialysis, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yuanhan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Huaban', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Jianchao', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Zhonglin', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Shuangxin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China. 13543456446@163.com.""}, {'ForeName': 'Xinling', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China. xinlingliang_ggh@163.com.""}]",BMC nephrology,['10.1186/s12882-019-1661-y']
3404,31519441,The Effect of Extended Continuous Positive Airway Pressure on Changes in Lung Volumes in Stable Premature Infants: A Randomized Controlled Trial.,"OBJECTIVE
To compare changes in lung volumes, as measured by functional residual capacity (FRC), through to discharge in stable infants randomized to 2 weeks of extended continuous positive airway pressure CPAP (eCPAP) vs CPAP discontinuation (dCPAP).
STUDY DESIGN
Infants born at ≤32 weeks of gestation requiring ≥24 hours of CPAP were randomized to 2 weeks of eCPAP vs dCPAP when meeting CPAP stability criteria. FRC was measured with the nitrogen washout technique. Infants were stratified by gestational age (<28 and ≥ 28 weeks) and twin gestation. A linear mixed-effects model was used to evaluate the change in FRC between the 2 groups. Data were analyzed blinded to treatment group allocation.
RESULTS
Fifty infants were randomized with 6 excluded, for a total of 44 infants. Baseline characteristics were similar in the 2 groups. The infants randomized to eCPAP vs dCPAP had a greater increase in FRC from randomization through 2 weeks (12.6 mL vs 6.4 mL; adjusted 95% CI, 0.78-13.47; P = .03) and from randomization through discharge (27.2 mL vs 17.1 mL; adjusted 95% CI, 2.61-17.59; P = .01).
CONCLUSIONS
Premature infants randomized to eCPAP had a significantly greater increase in FRC through discharge compared with those randomized to dCPAP. An increased change in FRC may lead to improved respiratory health.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT02249143.",2020,"CONCLUSIONS
Premature infants randomized to eCPAP had a significantly greater increase in FRC through discharge compared with those randomized to dCPAP.","['Infants were stratified by gestational age (<28 and\xa0≥\xa028\xa0weeks) and twin gestation', 'Fifty infants were randomized with 6 excluded, for a total of 44 infants', 'Stable Premature Infants', 'Infants born at ≤32\xa0weeks of gestation requiring ≥24\xa0hours of CPAP']","['extended continuous positive airway pressure CPAP (eCPAP) vs CPAP discontinuation (dCPAP', 'eCPAP vs dCPAP', 'eCPAP', 'Extended Continuous Positive Airway Pressure']","['Lung Volumes', 'FRC', 'FRC through discharge']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}, {'cui': 'C0016815', 'cui_str': 'Functional Residual Capacity'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",50.0,0.394834,"CONCLUSIONS
Premature infants randomized to eCPAP had a significantly greater increase in FRC through discharge compared with those randomized to dCPAP.","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Lam', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Schilling', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Scottoline', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Platteau', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Niederhausen', 'Affiliation': 'Biostatistics and Design Program, Oregon Health & Science University-Portland State University School of Public Health, Portland, OR.'}, {'ForeName': 'Kelli C', 'Initials': 'KC', 'LastName': 'Lund', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Schelonka', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Kelvin D', 'Initials': 'KD', 'LastName': 'MacDonald', 'Affiliation': 'Division of Pediatric Pulmonology, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Cindy T', 'Initials': 'CT', 'LastName': 'McEvoy', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Oregon Health & Science University, Portland, OR. Electronic address: mcevoyc@ohsu.edu.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.07.074']
3405,31846067,Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial).,"BACKGROUND
Several non-randomized and retrospective studies have suggested that intracorporeal anastomosis (IA) has advantages over extracorporeal anastomosis (EA) in laparoscopic right colectomy, but scientific evidence is lacking. The aim was to compare short-term outcomes and to define the possible benefits of IA compared with EA in elective laparoscopic right colectomy.
METHODS
An RCT was conducted from May 2015 to June 2018. The primary endpoint was duration of hospital stay. Secondary endpoints were intraoperative technical events and postoperative clinical outcomes.
RESULTS
A total of 140 patients were randomized. Duration of surgery was longer for procedures with an IA than in those with an EA (median 149 (range 95-215) versus 123 (60-240) min; P < 0·001). Wound length was shorter in the IA group (median 6·7 (4-9·5) versus 8·7 (5-13) cm; P < 0·001). Digestive function recovered earlier in patients with an IA (median 2·3 versus 3·3 days; P = 0·003) and the incidence of paralytic ileus was lower (13 versus 30 per cent; P = 0·022). Less postoperative analgesia was needed in the IA group (mean(s.d.) weighted analgesia requirement 39(24) versus 53(26); P = 0·001) and the pain score was also lower (P = 0·035). The postoperative decrease in haemoglobin level was smaller (mean(s.d.) 8·8(1·7) versus 17·1(1·7) mg/dl; P = 0·001) and there was less lower gastrointestinal bleeding (3 versus 14 per cent; P = 0·031) in the IA group. IA was associated with a significantly better rate of grade I and II complications (P = 0·016 and P = 0·037 respectively). The duration of hospital stay was slightly shorter in the IA group (median 5·7 (range 2-19) versus 6·6 (2-23) days; P = 0·194).
CONCLUSION
Duration of hospital stay was similar, but IA was associated with less pain and fewer complications. Registration number: NCT02667860 ( http://www.clinicaltrials.gov).",2020,IA was associated with a significantly better rate of grade I and II complications (P = 0·016 and P = 0·037 respectively).,"['elective laparoscopic right colectomy', '140 patients were randomized']","['extracorporeal anastomosis (EA', 'intracorporeal anastomosis (IA', 'EA', '17·1(1·7) mg/dl', 'intracorporeal versus extracorporeal anastomosis']","['haemoglobin level', 'pain score', 'Wound length', 'gastrointestinal bleeding', 'pain and fewer complications', 'postoperative analgesia', 'rate of grade I and II complications', 'Digestive function', 'duration of hospital stay', 'hospital stay', 'incidence of paralytic ileus', 'intraoperative technical events and postoperative clinical outcomes', 'Duration of surgery']","[{'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0192861', 'cui_str': 'Right colectomy (procedure)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0442087', 'cui_str': 'Extracorporeal (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0030446', 'cui_str': 'Paralytic Ileus'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",140.0,0.370699,IA was associated with a significantly better rate of grade I and II complications (P = 0·016 and P = 0·037 respectively).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bollo', 'Affiliation': 'Department of Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Turrado', 'Affiliation': 'Department of Surgery, Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rabal', 'Affiliation': 'Department of Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Carrillo', 'Affiliation': ""Department of Medicine, Hospital Vall d'Hebron, Autonomous University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Gich', 'Affiliation': 'Department of Clinical Epidemiology and Public Health, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Martinez', 'Affiliation': 'Department of Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hernandez', 'Affiliation': 'Department of Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Targarona', 'Affiliation': 'Department of Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}]",The British journal of surgery,['10.1002/bjs.11389']
3406,30496547,Psychophysiological Effects of Dance Movement Therapy and Physical Exercise on Older Adults With Mild Dementia: A Randomized Controlled Trial.,"OBJECTIVES
Dementia interferes with older adults' functioning in cognitive, daily, psychosocial, and neuroendocrine domains. The present study examined the psychophysiological effects of dance movement therapy (DMT) and physical exercise for older adults with dementia.
METHODS
This randomized controlled trial recruited 204 older adults diagnosed with mild dementia into the DMT, exercise, or waitlist control group. Both DMT and exercise interventions had similar intensity and comprised 24 hr of intervention that spanned over 12 weeks. All participants completed self-report questionnaires on psychosocial well-being, daily functioning, neurocognitive assessments, and salivary cortisol measures at baseline and 3 follow-up measurements more than 1 year.
RESULTS
The DMT group showed significant decreases in depression, loneliness, and negative mood (d = 0.33-0.42, p < .05) and improved daily functioning (d = 0.40, p < .01) and diurnal cortisol slope (d = 0.30, p < .01). The effects on daily functioning and cortisol slope remained at 1-year follow-up. The exercise group of matched intensity showed no significant effects on the outcomes.
DISCUSSION
The study findings support the potential utility of DMT as a multifaceted intervention for improving various aspects of functioning in older adults with declining cognitive abilities. The lack of beneficial effects for our exercise intervention and long-term DMT effects highlights the need to maintain persistent levels of exercise with adequate intensity and duration.",2020,"DMT group showed significant decreases in depression, loneliness, and negative mood (d = 0.33 - 0.42, p < 0.05) and improved daily functioning (d = 0.40, p < 0.01) and diurnal cortisol slope (d = 0.30, p < 0.01).","['204 older adults diagnosed with mild dementia into the DMT, exercise, or waitlist control group', 'older adults with mild dementia', 'older adults with declining cognitive abilities', 'older adults with dementia']","['Dance Movement Therapy and physical exercise', 'dance movement therapy (DMT) and physical exercise', 'DMT and exercise interventions', 'DMT']","['daily functioning', 'diurnal cortisol slope', 'daily functioning and cortisol slope', 'self-report questionnaires on psychosocial well-being, daily functioning, neurocognitive assessments, and salivary cortisol measures', 'depression, loneliness, and negative mood', 'Psychophysiological effects']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0027183', 'cui_str': 'Dimethyltryptamine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0027183', 'cui_str': 'Dimethyltryptamine'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0023974', 'cui_str': 'Loneliness'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",204.0,0.0789773,"DMT group showed significant decreases in depression, loneliness, and negative mood (d = 0.33 - 0.42, p < 0.05) and improved daily functioning (d = 0.40, p < 0.01) and diurnal cortisol slope (d = 0.30, p < 0.01).","[{'ForeName': 'Rainbow T H', 'Initials': 'RTH', 'LastName': 'Ho', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ted C T', 'Initials': 'TCT', 'LastName': 'Fong', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Wai Chi', 'Initials': 'WC', 'LastName': 'Chan', 'Affiliation': 'Department of Psychiatry, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Joseph S K', 'Initials': 'JSK', 'LastName': 'Kwan', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Patrick K C', 'Initials': 'PKC', 'LastName': 'Chiu', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Joshua C Y', 'Initials': 'JCY', 'LastName': 'Yau', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Linda C W', 'Initials': 'LCW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gby145']
3407,30613992,Effect of Early Parenteral Nutrition Discontinuation on Time to Regain Birth Weight in Very Low Birth Weight Infants: A Randomized Controlled Trial.,"BACKGROUND
Peripherally inserted central catheters (PICCs) are used to administer parenteral nutrition (PN) in very low birth weight infants (VLBW; <1500 g). Clinicians try to optimize early nutrition but also minimize the risks associated with intravascular devices. The objective of this study was to examine the early nutrition impact of discontinuing PN at different enteral feed volumes in VLBW infants.
METHODS
In this unmasked, multicenter, randomized controlled trial, patients were randomly assigned to PICC removal and PN discontinuation at an enteral feed volume of 100 mL/kg/day (intervention) or 140 mL/kg/day (control). Clinically stable VLBW infants with a PICC in situ who were receiving PN were eligible for inclusion. Infants with major congenital anomalies were excluded. A total of 139 patients were enrolled; 69 and 70 patients were randomized to the intervention and control groups, respectively. The primary outcome measure was the mean difference in time (days) to regain birth weight.
RESULTS
The groups were well matched at study entry. Patients in the intervention group regained birth weight more slowly (mean difference 1.5 days CI: 0.3-2.7 days, P = 0.01). The mean difference in time to regain birth weight for infants <1000 g was 2.8 days (95% CI: 0.8-4.8 days, P = 0.008).
CONCLUSIONS
In VLBW infants, early PICC removal at an enteral feed volume of 100 mL/kg/day compared with later removal at 140 mL/kg/day resulted in a significant delay in time to regain birth weight, and this delay was more pronounced in infants <1000 g.",2019,"Patients in the intervention group regained birth weight more slowly (mean difference 1.5 days CI: 0.3-2.7 days, P = 0.01).","['A total of 139 patients were enrolled; 69 and 70 patients', 'VLBW infants', 'infants <1000', 'Very Low Birth Weight Infants', 'Clinically stable VLBW infants with a PICC in situ who were receiving PN were eligible for inclusion', 'Infants with major congenital anomalies']","['Peripherally inserted central catheters (PICCs', 'Early Parenteral Nutrition Discontinuation', 'PICC removal and PN discontinuation']","['mean difference in time (days) to regain birth weight', 'early PICC removal', 'Time to Regain Birth Weight', 'birth weight', 'time to regain birth weight']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0444498', 'cui_str': 'In situ (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}]","[{'cui': 'C0179740', 'cui_str': 'Long line'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]",139.0,0.331403,"Patients in the intervention group regained birth weight more slowly (mean difference 1.5 days CI: 0.3-2.7 days, P = 0.01).","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Perrem', 'Affiliation': 'Coombe Women and Infants University Hospital, Dublin, Ireland.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Semberova', 'Affiliation': 'Coombe Women and Infants University Hospital, Dublin, Ireland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""O'Sullivan"", 'Affiliation': 'Coombe Women and Infants University Hospital, Dublin, Ireland.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Kieran', 'Affiliation': 'National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Colm P F', 'Initials': 'CPF', 'LastName': ""O'Donnell"", 'Affiliation': 'National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Martin John', 'Initials': 'MJ', 'LastName': 'White', 'Affiliation': 'Coombe Women and Infants University Hospital, Dublin, Ireland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Miletin', 'Affiliation': 'Coombe Women and Infants University Hospital, Dublin, Ireland.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1502']
3408,31738680,Comparison of a Silicon Skin Pad and a Tea Towel as Models for Learning a Simple Interrupted Suture.,"There has been rapid growth in the range of models available for teaching veterinary clinical skills. To promote further uptake, particularly in lower-income settings and for students to practice at home, factors to consider include cost, availability of materials and ease of construction of the model. Two models were developed to teach suturing: a silicon skin pad, and a tea towel (with a check pattern) folded and stapled to represent an incision. The models were reviewed by seven veterinarians, all of whom considered both suitable for teaching, with silicon rated as more realistic. The learning outcome of each model was compared after students trained to perform a simple interrupted suture. Thirty-two second-year veterinary students with no prior suturing experience were randomly assigned to three training groups: silicon skin pad or tea towel (both self-directed with an instruction booklet), or watching a video. Following training, all students undertook an Objective Structured Clinical Examination (OSCE), placing a simple interrupted suture in piglet cadaver skin. The OSCE pass rates of the three groups were silicon skin pad, 10/11; tea towel, 9/10; and video, 1/11. There was no significant difference between the model groups, but the model groups were significantly different from the video group ( p < .017). In conclusion, the tea towel was as effective as the silicon skin pad, but it was cheaper, simpler to make, and the materials were more readily available. In addition, both models were used effectively with an instruction booklet illustrating the value of self-directed learning to complement taught classes.",2020,"There was no significant difference between the model groups, but the model groups were significantly different from the video group ( p < .017).","['Thirty-two second-year veterinary students with no prior suturing experience', 'in piglet cadaver skin']","['silicon skin pad or tea towel (both self-directed with an instruction booklet), or watching a video', 'Silicon Skin Pad and a Tea Towel', 'Objective Structured Clinical Examination (OSCE), placing a simple interrupted suture', 'silicon skin pad, and a tea towel (with a check pattern) folded and stapled to represent an incision']",['OSCE pass rates'],"[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0006629', 'cui_str': 'Corpse'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]","[{'cui': 'C0037107', 'cui_str': 'Silicon'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0336616', 'cui_str': 'Towel, device (physical object)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}]",[],32.0,0.0155269,"There was no significant difference between the model groups, but the model groups were significantly different from the video group ( p < .017).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Baillie', 'Affiliation': 'Bristol Veterinary School.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Christopher', 'Affiliation': 'Bristol Veterinary School.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Catterall', 'Affiliation': 'Bristol Veterinary School.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kruydenberg', 'Affiliation': 'equine veterinarian working in practice in the United Kingdom and overseas.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lawrenson', 'Affiliation': 'Bristol Veterinary School.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Wonham', 'Affiliation': 'United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kilfeather', 'Affiliation': 'Department of Physiology.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'Warman', 'Affiliation': 'Bristol Veterinary School.'}]",Journal of veterinary medical education,['10.3138/jvme.2018-0001']
3409,31690831,Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16).,"BACKGROUND
The continuum of anti-HER2 agents is a standard treatment of HER2 + metastatic breast cancer (MBC). This study evaluated the efficacy of lapatinib plus vinorelbine in patients progressed on both trastuzumab and lapatinib treatments.
METHODS
A total of 149 patients were randomly assigned to lapatinib with vinorelbine (LV) (n = 75; lapatinib, 1000 mg daily; vinorelbine 20 mg/m 2 D1, D8 q3w) or vinorelbine (V) (n = 74; 30 mg/m 2 D1, D8 q3w). The primary endpoint was progression-free survival (PFS) rate at 18 weeks.
RESULTS
The median number of previous anti-HER2 therapies was 2 (range 2-5). There was no significant difference in PFS rate at 18 weeks between LV and V arms (45.9% vs 38.9%, p = 0.40). ORR was 19.7% in LV arm, and 16.9% in V arm (p = 0.88). PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61-1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72-1.58). Toxicity profiles were similar in both arms and all were manageable.
CONCLUSIONS
Lapatinib plus vinorelbine treatment was tolerable; however, it failed to demonstrate the clinical benefits over vinorelbine alone in patients with HER2 + MBC after progression on both trastuzumab and lapatinib.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov number NCT01730677.",2019,"PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61-1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72-1.58).","['patients progressed on both trastuzumab and lapatinib treatments', 'A total of 149 patients', 'patients with HER2\u2009+\u2009metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16']","['Lapatinib plus vinorelbine', 'lapatinib with vinorelbine (LV) (n\u2009=\u200975; lapatinib, 1000\u2009mg daily; vinorelbine 20\u2009mg/m 2 D1, D8 q3w) or vinorelbine (V', 'lapatinib and vinorelbine vs vinorelbine', 'vinorelbine', 'lapatinib plus vinorelbine']","['ORR', 'median number of previous anti-HER2 therapies', 'Toxicity profiles', 'progression-free survival (PFS) rate', 'PFS and OS', 'PFS rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",149.0,0.125427,"PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61-1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72-1.58).","[{'ForeName': 'Sung Hoon', 'Initials': 'SH', 'LastName': 'Sim', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'In Hae', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea. parkih@ncc.re.kr.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei University, College of Medicine, Yonsei Cancer Center, Seoul, Korea.'}, {'ForeName': 'Yu Jung', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology and Medical Oncology, Department of Internal medicine, Seoul National University Bundang Hospital, Bundang, Korea.'}, {'ForeName': 'Suee', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Internal medicine, Dong-A University, College of Medicine, Busan, Korea.'}, {'ForeName': 'Hee-Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Chung-Ang University, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yee Soo', 'Initials': 'YS', 'LastName': 'Chae', 'Affiliation': 'Kyungpook National University, College of Medicine, Daegu, Korea.'}, {'ForeName': 'Kyong Hwa', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Division of Oncology/Hematology, Korea University, Seoul, Korea.'}, {'ForeName': 'Byung-Ho', 'Initials': 'BH', 'LastName': 'Nam', 'Affiliation': 'Biometric Research Branch, Division of Cancer Epidemiology and Prevention, Research Institute & Hospital, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Keun Seok', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Jungsil', 'Initials': 'J', 'LastName': 'Ro', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea. jungsro@ncc.re.kr.'}]",British journal of cancer,['10.1038/s41416-019-0618-z']
3410,31029560,Phase III Trial of Intravenous Mannitol Versus Placebo During Nephron-sparing Surgery: Post Hoc Analysis of 3-yr Outcomes.,"Our recently reported phase III trial demonstrated that patients undergoing nephron-sparing surgery (NSS) with an estimated glomerular filtration rate (eGFR) of ≥45 ml/min/1.73 m 2 who received mannitol had no improvement in renal function at 6 mo compared with those who received placebo. Some authors have suggested that benefit is restricted to subgroups, such as those with comorbidities. We assessed whether preoperative eGFR, or other patient and surgical factors modified the effect of mannitol on postoperative outcomes at 6 mo and with extended follow-up. We also assessed whether mannitol was associated with differences in long-term GFR years after surgery. No significant difference between the mannitol or placebo groups (mean eGFR difference: 1.4; 95% confidence interval: -2.6, 5.3; p = 0.5) was found in the 134 patients with known eGFR at 3 yr after NSS. At both 6 mo and 3 yr, the effect of mannitol was not significantly modified by patient or surgical factors including preoperative eGFR. In summary, we validated our original trial conclusions by finding that intraoperative use of mannitol does not improve either short- or long-term renal function in patients undergoing NSS. Specifically, there is no evidence that comorbidities, including lower preoperative eGFR, modify the effect of mannitol. PATIENT SUMMARY: Use of mannitol at the time of partial nephrectomy does not improve either short- or long-term renal function even in patients with comorbidities, including lower preoperative renal function. The routine use of intraoperative mannitol should be discontinued.",2019,"No significant difference between the mannitol or placebo groups (mean eGFR difference: 1.4; 95% confidence interval: -2.6, 5.3; p = 0.5) was found in the 134 patients with known eGFR at 3 yr after NSS.","['patients undergoing NSS', '134 patients with known eGFR at 3\u2009yr after NSS', 'patients undergoing nephron-sparing surgery (NSS) with an estimated glomerular filtration rate (eGFR) of ≥45']","['intraoperative mannitol', 'mannitol', 'placebo', 'Intravenous Mannitol Versus Placebo']","['renal function', 'short- or long-term renal function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0027713', 'cui_str': 'Nephrons'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3811844'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",134.0,0.314702,"No significant difference between the mannitol or placebo groups (mean eGFR difference: 1.4; 95% confidence interval: -2.6, 5.3; p = 0.5) was found in the 134 patients with known eGFR at 3 yr after NSS.","[{'ForeName': 'Nathan C', 'Initials': 'NC', 'LastName': 'Wong', 'Affiliation': 'Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Ricardo G', 'Initials': 'RG', 'LastName': 'Alvim', 'Affiliation': 'Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Sjoberg', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Shingarev', 'Affiliation': 'Renal Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Nicholas E', 'Initials': 'NE', 'LastName': 'Power', 'Affiliation': 'Division of Urology, Western University, London, ON, Canada.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Spaliviero', 'Affiliation': 'Stony Brook Medicine, SUNY at Stony Brook, Stony Brook, NY, USA.'}, {'ForeName': 'Katie S', 'Initials': 'KS', 'LastName': 'Murray', 'Affiliation': 'Department of Surgery, Division of Urology, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Benfante', 'Affiliation': 'Sloan Kettering Institute, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'A Ari', 'Initials': 'AA', 'LastName': 'Hakimi', 'Affiliation': 'Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Russo', 'Affiliation': 'Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Coleman', 'Affiliation': 'Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: colemanj@mskcc.org.'}]",European urology focus,['10.1016/j.euf.2019.04.003']
3411,31868799,Protocol on transcranial alternating current stimulation for the treatment of major depressive disorder: a randomized controlled trial.,"BACKGROUND
Transcranial alternating current stimulation (tACS) offers a new approach for adult patients with major depressive disorder (MDD). The study is to evaluate the efficacy and safety of tACS treating MDD.
METHODS
This is an 8-week, double-blind, randomized, placebo-controlled study. Ninety-two drug-naive patients with MDD aged 18 to 65 years will receive 20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS targeting the forehead and both mastoid areas on weekdays for 4 consecutive weeks (week 4), following a 4-week observation period (week 8). The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8. Secondary outcomes are the rates of response at weeks 4 and 8 and rate of remission at week 4 based on HDRS-17, the proportion of participants having improvement in the clinical global impression-improvement, the change in HDRS-17 score (range, 0-52, with higher scores indicating more depression) over the study, and variations of brain imaging and neurocognition from baseline to week 4. Safety will be assessed by vital signs at weeks 4 and 8, and adverse events will be collected during the entire study.
DISCUSSION
The tACS applied in this trial may have treatment effects on MDD with minimal side effects.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, ChiCTR1800016479; http://www.chictr.org.cn/showproj.aspx?proj=22048.",2019,The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8.,"['major depressive disorder', 'Ninety-two drug-naive patients with MDD aged 18 to 65 years', 'adult patients with major depressive disorder (MDD']","['placebo', 'transcranial alternating current stimulation', 'Transcranial alternating current stimulation (tACS', '20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS']","['clinical global impression-improvement, the change in HDRS-17 score', 'remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score', 'rates of response at weeks 4 and 8 and rate of remission', 'efficacy and safety']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",92.0,0.347202,The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8.,"[{'ForeName': 'Hong-Xing', 'Initials': 'HX', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Puren Hospital, Beijing 100062, China.'}, {'ForeName': 'Wen-Rui', 'Initials': 'WR', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Wen-Feng', 'Initials': 'WF', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Xiao-Tong', 'Initials': 'XT', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Zhi-Chao', 'Initials': 'ZC', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Shu-Qin', 'Initials': 'SQ', 'LastName': 'Zhan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Bao-Quan', 'Initials': 'BQ', 'LastName': 'Min', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Chun-Qiu', 'Initials': 'CQ', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Ai-Hong', 'Initials': 'AH', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hai-Qing', 'Initials': 'HQ', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Medical Research & Biometrics Centre, National Centre for Cardiovascular Diseases, Beijing 102300, China.'}, {'ForeName': 'Tian-Mei', 'Initials': 'TM', 'LastName': 'Si', 'Affiliation': 'Peking University Sixth Hospital, Beijing 100083, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hai-Xia', 'Initials': 'HX', 'LastName': 'Leng', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Wei-Jun', 'Initials': 'WJ', 'LastName': 'Ding', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Tian-Yi', 'Initials': 'TY', 'LastName': 'Yan', 'Affiliation': 'School of Life Science, Beijing Institute of Technology, Beijing 100081, China.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000000589']
3412,31704939,"Stress and productivity patterns of interrupted, synergistic, and antagonistic office activities.","We describe a controlled experiment, aiming to study productivity and stress effects of email interruptions and activity interactions in the modern office. The measurement set includes multimodal data for n = 63 knowledge workers who volunteered for this experiment and were randomly assigned into four groups: (G1/G2) Batch email interruptions with/without exogenous stress. (G3/G4) Continual email interruptions with/without exogenous stress. To provide context, the experiment's email treatments were surrounded by typical office tasks. The captured variables include physiological indicators of stress, measures of report writing quality and keystroke dynamics, as well as psychometric scores and biographic information detailing participants' profiles. Investigations powered by this dataset are expected to lead to personalized recommendations for handling email interruptions and a deeper understanding of synergistic and antagonistic office activities. Given the centrality of email in the modern office, and the importance of office work to people's lives and the economy, the present data have a valuable role to play.",2019,"We describe a controlled experiment, aiming to study productivity and stress effects of email interruptions and activity interactions in the modern office.",['n\u2009=\u200963 knowledge workers who volunteered for this experiment'],['G1/G2) Batch email interruptions with/without exogenous stress'],"['Stress and productivity patterns of interrupted, synergistic, and antagonistic office activities', ""physiological indicators of stress, measures of report writing quality and keystroke dynamics, as well as psychometric scores and biographic information detailing participants' profiles""]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0033920', 'cui_str': 'Psychometrics'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",63.0,0.0280327,"We describe a controlled experiment, aiming to study productivity and stress effects of email interruptions and activity interactions in the modern office.","[{'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Zaman', 'Affiliation': 'Computational Physiology Laboratory, University of Houston, Houston, USA.'}, {'ForeName': 'Amanveer', 'Initials': 'A', 'LastName': 'Wesley', 'Affiliation': 'Computational Physiology Laboratory, University of Houston, Houston, USA.'}, {'ForeName': 'Dennis Rodrigo Da Cunha', 'Initials': 'DRDC', 'LastName': 'Silva', 'Affiliation': 'Perception, Sensing, and Instrumentation Laboratory, Texas A & M University, College Station, USA.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Buddharaju', 'Affiliation': 'Computational Physiology Laboratory, University of Houston, Houston, USA.'}, {'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'Akbar', 'Affiliation': 'Department of Informatics, University of California, Irvine, USA.'}, {'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': 'College of Information Studies, University of Maryland, College Park, USA.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Mark', 'Affiliation': 'Department of Informatics, University of California, Irvine, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gutierrez-Osuna', 'Affiliation': 'Perception, Sensing, and Instrumentation Laboratory, Texas A & M University, College Station, USA.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Pavlidis', 'Affiliation': 'Computational Physiology Laboratory, University of Houston, Houston, USA. ipavlidis@uh.edu.'}]",Scientific data,['10.1038/s41597-019-0249-5']
3413,30898550,"Deferoxamine mesylate in patients with intracerebral haemorrhage (i-DEF): a multicentre, randomised, placebo-controlled, double-blind phase 2 trial.","BACKGROUND
Iron from haemolysed blood is implicated in secondary injury after intracerebral haemorrhage. We aimed to assess the safety of the iron chelator deferoxamine mesylate in patients with intracerebral haemorrhage and to establish whether the drug merits investigation in a phase 3 trial.
METHODS
We did a multicentre, futility-design, randomised, placebo-controlled, double-blind, phase 2 trial at 40 hospitals in Canada and the USA. Adults aged 18-80 years with primary, spontaneous, supratentorial intracerebral haemorrhage were randomly assigned (1:1) to receive deferoxamine mesylate (32 mg/kg per day) or placebo (saline) infusions for 3 consecutive days within 24 h of haemorrhage onset. Randomisation was done via a web-based trial-management system centrally in real time, and treatment allocation was concealed from both participants and investigators. The primary outcome was good clinical outcome, which was defined as a modified Rankin Scale score of 0-2 at day 90. We did a futility analysis: if the 90% upper confidence bound of the absolute risk difference between the two groups in the proportion of participants with a good clinical outcome was less than 12% in favour of deferoxamine mesylate, then to move to a phase 3 efficacy trial would be futile. Primary outcome and safety data were analysed in the modified intention-to-treat population, comprising only participants in whom the study infusions were initiated. This trial is registered with ClinicalTrials.gov, number NCT02175225, and is completed.
FINDINGS
We recruited 294 participants between Nov 23, 2014, and Nov 10, 2017. The modified intention-to-treat population consisted of 144 patients assigned to the deferoxamine mesylate group and 147 assigned to the placebo group. At day 90, among patients with available data for the primary outcome, 48 (34%) of 140 participants in the deferoxamine mesylate group, and 47 (33%) of 143 patients in the placebo group, had modified Rankin Scale scores of 0-2 (adjusted absolute risk difference 0·6% [90% upper confidence bound 6·8%]). By day 90, 70 serious adverse events were reported in 39 (27%) of 144 patients in the deferoxamine mesylate group, and 78 serious adverse events were reported in 49 (33%) of 147 patients in the placebo group. Ten (7%) participants in the deferoxamine mesylate and 11 (7%) in the placebo group died. None of the deaths were judged to be treatment related.
INTERPRETATION
Deferoxamine mesylate was safe. However, the primary result showed that further study of the efficacy of deferoxamine mesylate with anticipation that the drug would significantly improve the chance of good clinical outcome (ie, mRS score of 0-2) at day 90 would be futile.
FUNDING
US National Institutes of Health and US National Institute of Neurological Disorders and Stroke.",2019,Ten (7%) participants in the deferoxamine mesylate and 11 (7%) in the placebo group died.,"['We recruited 294 participants between Nov 23, 2014, and Nov 10, 2017', 'patients with intracerebral haemorrhage', 'Adults aged 18-80 years with primary, spontaneous, supratentorial intracerebral haemorrhage', 'patients with intracerebral haemorrhage (i-DEF', '40 hospitals in Canada and the USA', '144 patients assigned to the']","['Deferoxamine mesylate', 'placebo (saline) infusions', 'placebo', 'iron chelator deferoxamine mesylate', 'deferoxamine mesylate']","['serious adverse events', 'modified Rankin Scale scores', 'modified Rankin Scale score', 'safety data']","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial (qualifier value)'}, {'cui': 'C0054282', 'cui_str': 'tribufos'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0011148', 'cui_str': 'deferoxamine mesylate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0007974', 'cui_str': 'Complexons'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",294.0,0.668382,Ten (7%) participants in the deferoxamine mesylate and 11 (7%) in the placebo group died.,"[{'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'Selim', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: mselim@bidmc.harvard.edu.'}, {'ForeName': 'Lydia D', 'Initials': 'LD', 'LastName': 'Foster', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Claudia S', 'Initials': 'CS', 'LastName': 'Moy', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Xi', 'Affiliation': 'Department of Neurosurgery, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Health Science Center, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Lewis B', 'Initials': 'LB', 'LastName': 'Morgenstern', 'Affiliation': 'Department of Neurology, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Greenberg', 'Affiliation': 'Harvard Medical School, Boston, MA, USA; Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'James', 'Affiliation': 'Department of Anesthesiology and Neurology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Vineeta', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Clark', 'Affiliation': 'Oregon Health and Science University Hospital, Portland, OR, USA.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Norton', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Sharon D', 'Initials': 'SD', 'LastName': 'Yeatts', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30069-9']
3414,31753900,"Effects of basic carbohydrate counting versus standard outpatient nutritional education (The BCC Study): study protocol for a randomised, parallel open-label, intervention study focusing on HbA1c and glucose variability in patients with type 2 diabetes.","INTRODUCTION
Recommendations on energy intake are key in body weight management to improve glycaemic control in people with type 2 diabetes (T2D). International clinical guidelines recommend a variety of eating patterns to promote energy restriction as the primary dietetic approach to body weight control in managing T2D. In addition, individualised guidance on self-monitoring carbohydrate intake to optimise meal timing and food choices (eg, basic carbohydrate counting (BCC)) is recommended to achieve glycaemic control. However, the evidence for this approach in T2D is limited. The objective of this study was to compare the effect of an educational programme in BCC as add-on to the usual dietary care on glycaemic control in people with T2D.
METHODS AND ANALYSES
The study is designed as a randomised, controlled trial with a parallel-group design. The study duration is 12 months with data collection at baseline, and after 6 and 12 months. We plan to include 226 adults with T2D. Participants will be randomised to one of two interventions: (1) BCC as add-on to usual dietary care or (2) usual dietary care. The primary outcome is changes in glycated haemoglobin A1c or mean amplitude of glycaemic excursions from baseline and after 6-month intervention between and within study groups. Further outcome measures include changes in time in range, body weight and composition, lipid profile, blood pressure, mathematical literacy skills, carbohydrate estimation accuracy, dietary intake, diet-related quality of life, perceived competencies in diet and diabetes and perceptions of an autonomy supportive dietician-led climate, physical activity and urinary biomarkers.
ETHICS AND DISSEMINATION
The protocol has been approved by the Ethics Committee of the Capital Region, Copenhagen, Denmark. Study findings will be disseminated widely through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER
NCT03623139.",2019,The primary outcome is changes in glycated haemoglobin A1c or mean amplitude of glycaemic excursions from baseline and after 6-month intervention between and within study groups.,"['people with type 2 diabetes (T2D', 'patients with type 2 diabetes', '226 adults with T2D. Participants', 'people with T2D']","['optimise meal timing and food choices (eg, basic carbohydrate counting (BCC', 'basic carbohydrate counting versus standard outpatient nutritional education', 'educational programme', 'BCC as add-on to usual dietary care or (2) usual dietary care']","['glycated haemoglobin A1c or mean amplitude of glycaemic excursions', 'changes in time in range, body weight and composition, lipid profile, blood pressure, mathematical literacy skills, carbohydrate estimation accuracy, dietary intake, diet-related quality of life, perceived competencies in diet and diabetes and perceptions of an autonomy supportive dietician-led climate, physical activity and urinary biomarkers']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1562940', 'cui_str': 'Carbohydrate counting'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0034380'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",226.0,0.0908177,The primary outcome is changes in glycated haemoglobin A1c or mean amplitude of glycaemic excursions from baseline and after 6-month intervention between and within study groups.,"[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Ewers', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark bettina.ewers@regionh.dk.'}, {'ForeName': 'Jens Meldgaard', 'Initials': 'JM', 'LastName': 'Bruun', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus, Denmark, Aarhus, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-032893']
3415,31748594,A Four Month Randomized Controlled Trial on the Efficacy of Once-daily Fenofibrate Monotherapy in Persons with Spinal Cord Injury.,"An open-label, randomized clinical trial of once-daily fenofibrate monotherapy administered for 2- (Mo2) and 4- (Mo4) months using modified intervention thresholds for triglyceride (TG) was performed in persons with chronic spinal cord injury (SCI). Fenofibrate (145 mg tablet) was self-administered daily in 10 persons with SCI for 4 months with monthly blood testing to quantify the lipoprotein profile (e.g., serum TG, LDL-C, and HDL-C concentrations). Eight SCI participants were control subjects. In comparison to the control group, the treatment group at Mo2 had a 40% (±12%; p < 0.05) reduction in serum TG concentration, a 28% (±21%; p < 0.05) increase in HDL-C and 14% (±20%; p < 0.05) decline in LDL-C. In the same comparison at Mo4, the treatment group maintained a 40% (±20%; p < 0.05) reduction in serum TG concentration, had an 18% in reduction in LDL-C (±12%; p < 0.05) and a 23% (±23%; p < 0.05) increase in HDL-C. Fenofibrate monotherapy for Mo2 and Mo4 initiated in persons with SCI resulted in a robust and favorable change in the serum lipoprotein profile and ratios, suggesting reduced risk for cardiovascular disease.",2019,"In the same comparison at Mo4, the treatment group maintained a 40% (±20%; p < 0.05) reduction in serum TG concentration, had an 18% in reduction in LDL-C (±12%; p < 0.05) and a 23% (±23%; p < 0.05) increase in HDL-C. Fenofibrate monotherapy for Mo2 and Mo4 initiated in persons with SCI resulted in a robust and favorable change in the serum lipoprotein profile and ratios, suggesting reduced risk for cardiovascular disease.","['persons with chronic spinal cord injury (SCI', 'Persons with Spinal Cord Injury', 'Eight SCI participants were control subjects']","['Fenofibrate', 'Once-daily Fenofibrate Monotherapy', 'fenofibrate monotherapy administered for 2- (Mo2) and 4- (Mo4) months using modified intervention thresholds for triglyceride (TG']","['HDL-C', 'serum TG concentration', 'LDL-C', 'serum lipoprotein profile and ratios']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0196628,"In the same comparison at Mo4, the treatment group maintained a 40% (±20%; p < 0.05) reduction in serum TG concentration, had an 18% in reduction in LDL-C (±12%; p < 0.05) and a 23% (±23%; p < 0.05) increase in HDL-C. Fenofibrate monotherapy for Mo2 and Mo4 initiated in persons with SCI resulted in a robust and favorable change in the serum lipoprotein profile and ratios, suggesting reduced risk for cardiovascular disease.","[{'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'La Fountaine', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA. michael.lafountaine@va.gov.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cirnigliaro', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Hobson', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Lombard', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Adam F', 'Initials': 'AF', 'LastName': 'Specht', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Dyson-Hudson', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Kirshblum', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Bauman', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA.'}]",Scientific reports,['10.1038/s41598-019-53753-7']
3416,31021124,The role of patient beliefs in open-label placebo effects.,"OBJECTIVE
Recent research on open-label placebos, or placebos administered without deception or concealment, suggests that they can be effective in a variety of conditions. The current research sought to unpack the mechanisms underlying the treatment efficacy of open-label placebos.
METHOD
A health care provider induced an allergic reaction in 148 participants via a histamine skin prick test. Participants were then exposed to 1 of 4 conditions additively leveraging various mechanisms of open-label placebo treatments: a supportive patient-provider relationship, a medical ritual, positive expectations, and a rationale about the power of placebos.
RESULTS
There were no main effects of condition on allergic responses. However, participant beliefs about placebos moderated the effect of open-label placebo treatment condition on physiological allergic reactions: the condition including all 4 components of open-label placebos (a supportive patient-provider relationship, a medical ritual, positive expectations, and a rationale about the power of placebos) significantly reduced physiological allergic reaction among participants with a strong belief in placebos compared with participants in the control group.
CONCLUSION
Participants' beliefs about placebos interact with information from the provider to reduce physiological allergic reactions in response to an open-label placebo treatment. This study underscores the importance of measuring and understanding how participants' beliefs influence outcomes of treatment, and furthers our understanding of when and how open-label placebo treatments work. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,There were no main effects of condition on allergic responses.,"['participants with a strong belief in placebos compared with participants in the control group', '148 participants via a histamine skin prick test']",['placebos'],"['physiological allergic reaction', 'physiological allergic reactions', 'allergic responses']","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0430561', 'cui_str': 'Prick test (procedure)'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}]",,0.0508888,There were no main effects of condition on allergic responses.,"[{'ForeName': 'Kari A', 'Initials': 'KA', 'LastName': 'Leibowitz', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Emerson J', 'Initials': 'EJ', 'LastName': 'Hardebeck', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'J Parker', 'Initials': 'JP', 'LastName': 'Goyer', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Alia J', 'Initials': 'AJ', 'LastName': 'Crum', 'Affiliation': 'Department of Psychology.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000751']
3417,31784559,Presynaptic dopamine function measured with [ 18 F]fluorodopa and L-DOPA effects on impulsive choice.,"We previously reported that L-DOPA effects on reward-based decision-making in a randomized, placebo-controlled, double-blind, crossover study were consistent with an inverted U-shaped function whereby both low and high extremes of dopamine signaling are associated with high-impulsive choice. To test this hypothesis, we performed [ 18 F]DOPA positron emission tomography in 60 of the 87 participants in that study, and measured the effective distribution volume ratio (EDVR) of [ 18 F]DOPA influx rate to [ 18 F]dopamine washout rate, an index of presynaptic dopaminergic function. Participants with higher baseline EDVR self-reported lower impulsivity, and discounted rewards as a function of delay more strongly after receiving L-DOPA, whereas the opposite was detected for those with lower baseline EDVR. Our findings support a relationship of striatal dopaminergic activity to trait impulsivity, and the view that there is a non-linear, possibly inverted U-shaped relationship of striatal dopaminergic function with delay discounting. Individuals with optimal dopamine signaling would become more impulsive when receiving dopamine-enhancing drugs, whereas those with suboptimal dopaminergic signaling would benefit and exhibit less impulsive choice. Consideration of differences in endogenous dopamine signaling and possibly also other neurotransmitter activity may be crucial to advance understanding of the neurobiochemical mechanisms of impulsive decision-making and related mental disorders.",2019,"Participants with higher baseline EDVR self-reported lower impulsivity, and discounted rewards as a function of delay more strongly after receiving L-DOPA, whereas the opposite was detected for those with lower baseline EDVR.",['in 60 of the 87 participants in that study'],"['placebo', 'F]DOPA positron emission tomography']","['effective distribution volume ratio (EDVR) of [ 18 F]DOPA influx rate to [ 18 F]dopamine washout rate, an index of presynaptic dopaminergic function']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'function'}]",87.0,0.115468,"Participants with higher baseline EDVR self-reported lower impulsivity, and discounted rewards as a function of delay more strongly after receiving L-DOPA, whereas the opposite was detected for those with lower baseline EDVR.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Petzold', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Shakoor', 'Initials': 'S', 'LastName': 'Pooseh', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Liane', 'Initials': 'L', 'LastName': 'Oehme', 'Affiliation': 'Department of Nuclear Medicine, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Beuthien-Baumann', 'Affiliation': 'Department of Nuclear Medicine, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Edythe D', 'Initials': 'ED', 'LastName': 'London', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Department of Molecular and Medical Pharmacology and the Brain Research Institute, University of California at Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Goschke', 'Affiliation': 'Department of Psychology and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Smolka', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany. michael.smolka@tu-dresden.de.'}]",Scientific reports,['10.1038/s41598-019-54329-1']
3418,31759770,Fish oil supplementation with various lipid emulsions suppresses in vitro cytokine release in home parenteral nutrition patients: a crossover study.,"Long-chain n-3 polyunsaturated fatty acids modulate immune cell functions. The primary objective of this study was to evaluate the impact of different lipid emulsions (LEs) with supplemented doses of fish oil (FO) on serum cytokine concentration and in vitro cytokine production in patients with intestinal failure on home parenteral nutrition (HPNPs). We hypothesized that FO supplementation would diminish lipopolysaccharide (LPS)-stimulated cytokine production. Twelve HPNPs receiving Smoflipid for at least 3 months were given FO (Omegaven) for a further 4 weeks. After this cycle, the patients were randomized to subsequently receive 1 cycle with Lipoplus and 1 cycle with ClinOleic for 6 weeks or vice versa plus 4 weeks of added Omegaven after each cycle in a crossover design. Comparison of the baseline LE regimens showed lower LPS-stimulated production of IL-1β in the HPNPs on Lipoplus than on the Smoflipid and ClinOleic regimens, as well as lower IL-8 compared to the Smoflipid regimen. Omegaven reduced IL-8 concentration in serum under the Lipoplus regimen and diminished LPS-stimulated production of IL-1β under the Smoflipid and ClinOleic. IL-6 and TNF-α production was depressed only in those on Smoflipid. Irrespective of the LE used, the HPNPs compared to the healthy controls showed higher IL-6, IL-8, and TNF-α concentrations in serum and LPS-stimulated production of IL-6 as well as lower n-6/n-3 long-chain polyunsaturated fatty acids in the erythrocyte phospholipids. LPS-stimulated production of IL-6 correlated negatively with the parenteral dose of eicosapentaenoic acid + docosahexaenoic acid. In conclusion, FO-supplemented parenteral nutrition suppresses in vitro cytokine production.",2019,"Irrespective of the LE used, the HPNPs compared to the healthy controls showed higher IL-6, IL-8, and TNF-α concentrations in serum and LPS-stimulated production of IL-6 as well as lower n-6/n-3 long-chain polyunsaturated fatty acids in the erythrocyte phospholipids.","['patients with intestinal failure on home parenteral nutrition (HPNPs', 'home parenteral nutrition patients']","['lipid emulsions (LEs', 'Long-chain n-3 polyunsaturated fatty acids', 'fish oil (FO', 'eicosapentaenoic acid + docosahexaenoic acid', 'FO supplementation', 'Fish oil supplementation with various lipid emulsions']","['IL-8 concentration', 'vitro cytokine production', 'vitro cytokine release', 'LPS-stimulated production of IL-1β under the Smoflipid and ClinOleic. IL-6 and TNF-α production', 'serum cytokine concentration and in vitro cytokine production', 'IL-6, IL-8, and TNF-α concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0079543', 'cui_str': 'Parenteral Nutrition, Home'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}]","[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0033268'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C3252721', 'cui_str': 'ClinOleic'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}]",,0.0323735,"Irrespective of the LE used, the HPNPs compared to the healthy controls showed higher IL-6, IL-8, and TNF-α concentrations in serum and LPS-stimulated production of IL-6 as well as lower n-6/n-3 long-chain polyunsaturated fatty acids in the erythrocyte phospholipids.","[{'ForeName': 'Frantisek', 'Initials': 'F', 'LastName': 'Novak', 'Affiliation': 'Charles University, 1st Faculty of Medicine and General University Hospital, 4th Department of Internal Medicine, Prague, Czech Republic. Electronic address: fnova@lf1.cuni.cz.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Vecka', 'Affiliation': 'Charles University, 1st Faculty of Medicine and General University Hospital, 4th Department of Internal Medicine, Prague, Czech Republic.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Meisnerova', 'Affiliation': 'Charles University, 1st Faculty of Medicine and General University Hospital, 4th Department of Internal Medicine, Prague, Czech Republic.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Sevela', 'Affiliation': 'Charles University, 1st Faculty of Medicine and General University Hospital, 4th Department of Internal Medicine, Prague, Czech Republic.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Vavrova', 'Affiliation': 'Charles University, 1st Faculty of Medicine and General University Hospital, 4th Department of Internal Medicine, Prague, Czech Republic.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Rychlikova', 'Affiliation': 'Charles University, 1st Faculty of Medicine and General University Hospital, 4th Department of Internal Medicine, Prague, Czech Republic.'}, {'ForeName': 'Ludmila', 'Initials': 'L', 'LastName': 'Dolezalova', 'Affiliation': 'Institute of Hematology and Blood Transfusion, Prague, Czech Republic.'}, {'ForeName': 'Denisa', 'Initials': 'D', 'LastName': 'Myslivcova', 'Affiliation': 'Institute of Hematology and Blood Transfusion, Prague, Czech Republic.'}, {'ForeName': 'Ales', 'Initials': 'A', 'LastName': 'Zak', 'Affiliation': 'Charles University, 1st Faculty of Medicine and General University Hospital, 4th Department of Internal Medicine, Prague, Czech Republic.'}, {'ForeName': 'Libor', 'Initials': 'L', 'LastName': 'Vitek', 'Affiliation': 'Charles University, 1st Faculty of Medicine and General University Hospital, Institute of Medical Biochemistry and Laboratory Diagnostics, Prague, Czech Republic.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Novakova', 'Affiliation': 'Charles University in Prague, Faculty of Science, Department of Physiology, Prague, Czech Republic; Institute of Physiology, Academy of Sciences of the Czech Republic, Prague, Czech Republic.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2019.10.004']
3419,31563804,Positive urgency worsens the impact of normative feedback on 21st birthday drinking.,"BACKGROUND
The 21st birthday is associated with more alcohol consumption and negative consequences than any other occasion. The current study investigated how positive urgency, the tendency to act rashly in response to positive emotions, influences 21st birthday drinking and the effectiveness of a single event text message intervention designed to reduce 21st birthday drinking and related negative consequences.
METHODS
Participants were 183 undergraduate students (69% female, 86% white) about to turn 21. Participants were randomly assigned to either a text message intervention or control condition. Those in the intervention condition received one text message the day before their 21st birthday that provided personalized normative feedback and one text message on the day of their 21st birthday. Participants reported actual alcohol consumption the day after their 21st birthday celebration.
RESULTS
Hierarchical linear regression found that, after controlling for sex, intervention condition, and planned drinking, positive urgency was associated with greater number of drinks (β = .15, p = .031) and drinking problems (β = .25, p = .001). A moderated-mediation model was significant (B = 0.42, CI95 [.10, .76]): At high levels of positive urgency, the intervention condition was associated with drinking more than planned, which significantly mediated the relationship between intervention and alcohol-related consequences; the mediation was not significant at mean or low levels of positive urgency.
CONCLUSIONS
These findings are the first to link positive urgency with 21st birthday drinking and to empirically demonstrate that positive urgency negatively impacts the effectiveness of an intervention aimed at reducing alcohol consumption.",2019,"A moderated-mediation model was significant (B = 0.42, CI95 [.10, .76]):","['Participants were 183 undergraduate students (69% female, 86% white) about to turn 21']",['text message intervention or control condition'],"['actual alcohol consumption', 'drinking problems']","[{'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",,0.0198354,"A moderated-mediation model was significant (B = 0.42, CI95 [.10, .76]):","[{'ForeName': 'Zachary T', 'Initials': 'ZT', 'LastName': 'Whitt', 'Affiliation': 'Department of Psychology, Indiana University - Purdue University Indianapolis, Indianapolis, IN, United States. Electronic address: zacwhitt@iu.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bernstein', 'Affiliation': 'Brown University, Center for Alcohol and Addiction Studies, Providence, RI, United States.'}, {'ForeName': 'Nichea', 'Initials': 'N', 'LastName': 'Spillane', 'Affiliation': 'Department of Psychology, University of Rhode Island, Kingston, RI, United States.'}, {'ForeName': 'L A R', 'Initials': 'LAR', 'LastName': 'Stein', 'Affiliation': 'Brown University, Center for Alcohol and Addiction Studies, Providence, RI, United States; Department of Psychology, University of Rhode Island, Kingston, RI, United States; Rhode Island Training School, Department of Children, Youth and Families, Cranston, RI, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Schick', 'Affiliation': 'Department of Psychology, University of Rhode Island, Kingston, RI, United States.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Cyders', 'Affiliation': 'Department of Psychology, Indiana University - Purdue University Indianapolis, Indianapolis, IN, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107559']
3420,31767591,Improvement of perioperative care of the elderly patient (PeriAge): protocol of a controlled interventional feasibility study.,"INTRODUCTION
Geriatric patients have a pronounced risk to suffer from postoperative complications. While effective risk-specific perioperative measures have been studied in controlled experimental settings, they are rarely found in routine healthcare. This study aims (1) to implement a multicomponent preoperative and intraoperative intervention, and investigate its feasibility, and (2) exploratorily assess the effectiveness of the intervention in routine healthcare.
METHODS AND ANALYSIS
Feasibility and exploratory effectiveness of the intervention will be investigated in a monocentric, prospective, non-randomised, controlled trial. The intervention includes systematic information for patients and family about measures to prevent postoperative complications; preoperative screening for frailty, malnutrition, strength and mobility with nutrient supplementation and physical exercise (prehabilitation) as needed. Further components focus on potentially inadequate medication, patient blood-management and carbohydrate loading prior to surgery, retainment of orientation aids in the operating room and a geriatric anaesthesia concept. Data will successively be collected from control, implementation and intervention groups. Patients aged 65+ with impending surgery will be included. A sample size of 240, n=80 per group, is planned. Assessments will take place at inclusion and 2, 30 and 180 days after surgery. Mixed-methods analyses will be performed. Exploratory effectiveness will be assessed using mixed segmented regressions. The primary endpoint is functional status. Secondary endpoints include cognitive performance, health-related quality of life, length of inpatient stay and occurrence of postoperative complications. Feasibility will be assessed through semi-structured interviews with staff and patients and quantitative analyses of the data quality, focussing on practicability, acceptance, adoption and fidelity to protocol.
ETHICS AND DISSEMINATION
The study will be carried out in accordance with the Helsinki Declaration and to principles of good scientific practice. The Ethics Committee of the Medical Association Hamburg, Germany, approved the protocol (study ID: PV5596). Results will be disseminated in scientific journals and healthcare conferences.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov Identifier: NCT03325413.",2019,"Secondary endpoints include cognitive performance, health-related quality of life, length of inpatient stay and occurrence of postoperative complications.","['Geriatric patients', 'Patients aged 65+ with impending surgery will be included']","['multicomponent preoperative and intraoperative intervention', 'nutrient supplementation and physical exercise (prehabilitation']","['cognitive performance, health-related quality of life, length of inpatient stay and occurrence of postoperative complications', 'functional status', 'Exploratory effectiveness']","[{'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0420512', 'cui_str': 'Inpatient stay (finding)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0980783,"Secondary endpoints include cognitive performance, health-related quality of life, length of inpatient stay and occurrence of postoperative complications.","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Olotu', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lebherz', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany l.lebherz@uke.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mende', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Plümer', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alwin E', 'Initials': 'AE', 'LastName': 'Goetz', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Zöllner', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Kiefmann', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-031837']
3421,31903494,Evaluating the Effects of a Brief Tobacco Intervention in the US Air Force.,"INTRODUCTION
Military personnel have among the highest rates of tobacco use in the United States. Unfortunately, there are few interventions aimed at reducing tobacco use among this vulnerable population. The current study addresses this need by evaluating the short-term effectiveness of a Brief Tobacco Intervention (BTI), a 40-min group-based intervention designed to reduce contemporary patterns of tobacco use among a sample of US military enlistees during an 11-week period of involuntary tobacco abstinence.
AIMS AND METHODS
Participants were 2999 US Air Force Technical Trainees at Joint Base San Antonio-Lackland Air Force Base in San Antonio, Texas from April 2017 through January 2018. Participants were cluster randomized to three conditions: (1) BTI + Airman's Guide to Remaining Tobacco Free (AG), (2) AG intervention, or (3) standard smoking cessation intervention. The primary analysis was a comparison of the interventions' efficacies in preventing tobacco use during Technical Training, conducted using a generalized estimating equations logistic regression model controlling for covariates. Multiple imputation was used to account for loss to follow-up.
RESULTS
There was not a significant difference by condition in the use of tobacco products at follow-up (p = .454). The BTI + AG condition did produce short-term changes in perceived harm, intentions to use tobacco, knowledge about tobacco products, and normative beliefs.
CONCLUSIONS
These findings suggest that while the intervention was effective in the short term, it was not potent enough over a 12-week period to prevent Airmen from initiating tobacco use. Future studies should examine whether adding a booster session or media campaign enhances the effectiveness of the intervention.
IMPLICATIONS
Despite the fact that most Airmen believe they will remain tobacco free following the ban in Technical Training, a large percentage of these Airmen resume and initiate tobacco use during this high-risk period. As a result, there is a need for interventions targeting the range of tobacco available to military trainees during a teachable moment when they report intentions to remain tobacco free. The current study shows that a BTI has promise in reducing long-term tobacco use, when coupled with additional interventions, such as a booster session or a media campaign.",2020,There was not a significant difference by condition in the use of tobacco products at follow-up (p=0.454).,"['Participants were 2,999 US Air Force Technical Trainees at Joint Base San Antonio-Lackland Air Force Base in San Antonio, Texas from April 2017 through January 2018']","['Brief Tobacco Intervention (BTI', 'Brief Tobacco Intervention', ""BTI + Airman's Guide to Remaining Tobacco Free (AG), (2) AG intervention, or (3) standard smoking cessation intervention""]",[],"[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C4521691', 'cui_str': 'US Military enlisted E2'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",[],,0.0315383,There was not a significant difference by condition in the use of tobacco products at follow-up (p=0.454).,"[{'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Little', 'Affiliation': 'Center for Addiction and Prevention Research, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Fahey', 'Affiliation': 'Department of Psychology, University of Memphis, Memphis, TN.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Klesges', 'Affiliation': 'Center for Addiction and Prevention Research, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'McMurry', 'Affiliation': 'Center for Addiction and Prevention Research, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Gerald W', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'Center for Addiction and Prevention Research, University of Virginia School of Medicine, Charlottesville, VA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa001']
3422,31931184,Clinical application of flap or flapless buccal surgery on the extractions of mesially/horizontally impacted 3rd molar with high or medium position impact: A comparative study.,"PURPOSE
To investigate and compare the clinical application of flap or flapless buccal surgery on the extractions of mesially/horizontally impacted 3rd molar with high or medium position impact in terms of the average surgery duration, number of root fracture, postoperative pain degree and duration, postoperative swelling degree and duration, degree of limitation of mouth opening.
MATERIALS AND METHODS
The present study was conducted of 28 patients who were examined and underwent bilateral extraction of impacted mandibular 3rd molar. One molar was randomly extracted with flap buccal surgery (Control Group, CG) and the other one with flapless buccal surgery (Experimental Group, EG) in the same patient.
RESULTS
Gender distribution, average age, average surgery duration and number of root fracture between the two groups were not statistically significant (P>0.05). The postoperative pain degree, swelling degree and degree of limitation of mouth opening were all significantly greater in CG than EG. Moreover, the duration of postoperative pain and swelling were all were all significantly longer in CG than EG (0.010.05).",['28 patients who were examined and underwent bilateral extraction of impacted mandibular 3rd molar'],"['Flap or Flapless Buccal Surgery', 'flap buccal surgery (Control Group, CG) and the other one with flapless buccal surgery (Experimental Group, EG', 'flap or flapless buccal surgery', 'flap buccal surgery']","['duration of postoperative pain and swelling', 'postoperative pain degree, swelling degree and degree of limitation of mouth opening', 'average surgery duration, number of root fracture, postoperative pain degree and duration, postoperative swelling degree and duration, degree of limitation of mouth opening', 'swelling, pain and degree of limitation of mouth opening', 'average surgery duration and number of root fracture']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}]","[{'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0225695,"RESULTS
Gender distribution, average age, average surgery duration and number of root fracture between the two groups were not statistically significant (P>0.05).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': 'Department of Periodontics-implantology, Stomatological Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Periodontics-implantology, Stomatological Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ren', 'Affiliation': 'Oral Health Centre, Stomatological Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Periodontics-implantology, Stomatological Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Periodontics-implantology, Stomatological Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rong', 'Affiliation': 'Department of Periodontics-implantology, Stomatological Hospital, Southern Medical University, Guangzhou, China. Electronic address: 23554800@qq.com.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University, Guangzhou, China. Electronic address: 187234415@smu.edu.cn.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2020.01.002']
3423,31961377,Association of Default Electronic Medical Record Settings With Health Care Professional Patterns of Opioid Prescribing in Emergency Departments: A Randomized Quality Improvement Study.,"Importance
Prescription opioids play a significant role in the ongoing opioid crisis. Guidelines and physician education have had mixed success in curbing opioid prescriptions, highlighting the need for other tools that can change prescriber behavior, including nudges based in behavioral economics.
Objective
To determine whether and to what extent changes in the default settings in the electronic medical record (EMR) are associated with opioid prescriptions for patients discharged from emergency departments (EDs).
Design, Setting, and Participants
This quality improvement study randomly altered, during a series of five 4-week blocks, the prepopulated dispense quantities of discharge prescriptions for commonly prescribed opioids at 2 large, urban EDs. These changes were made without announcement, and prescribers were not informed of the study itself. Participants included all health care professionals (physicians, nurse practitioners, and physician assistants) working clinically in either of the 2 EDs. Data were collected from November 28, 2016, through July 9, 2017, and analyzed from July 16, 2017, through May 14, 2018.
Interventions
Default quantities for opioids were changed from status quo quantities of 12 and 20 tablets to null, 5, 10, and 15 tablets according to a block randomization scheme. Regardless of the default quantity, each health care professional decided for whom to prescribe opioids and could modify the quantity prescribed without restriction.
Main Outcomes and Measures
The primary outcome was the number of tablets of opioid-containing medications prescribed under each default setting.
Results
A total of 104 health care professionals wrote 4320 prescriptions for opioids during the study period. Using linear regression, an increase of 0.19 tablets prescribed (95% CI, 0.15-0.22) was found for each tablet increase in default quantity. When evaluating each of the 15 pairwise comparisons of default quantities (eg, 5 vs 15 tablets), a lower default was associated with a lower number of pills prescribed in more than half (8 of the 15) of the pairwise comparisons; there was a higher quantity in 1 and no difference in 6 comparisons.
Conclusions and Relevance
These findings suggest that default settings in the EMR may influence the quantity of opioids prescribed by health care professionals. This low-cost, easily implementable, EMR-based intervention could have far-reaching implications for opioid prescribing and could be used as a tool to help combat the opioid epidemic.
Trial Registration
ClinicalTrials.gov identifier: NCT04155229.",2020,"Using linear regression, an increase of 0.19 tablets prescribed (95% CI, 0.15-0.22) was found for each tablet increase in default quantity.","['Data were collected from November 28, 2016, through July 9, 2017, and analyzed from July 16, 2017, through May 14, 2018', '104 health care professionals wrote 4320 prescriptions for opioids during the study period', 'patients discharged from emergency departments (EDs', 'Participants included all health care professionals (physicians, nurse practitioners, and physician assistants) working clinically in either of the 2 EDs', 'Emergency Departments']",[],['number of tablets of opioid-containing medications prescribed under each default setting'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C4517776', 'cui_str': 'Four thousand three hundred and twenty'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C0031833', 'cui_str': ""Physicians' Extenders""}, {'cui': 'C0043227', 'cui_str': 'Work'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C2239117', 'cui_str': 'Drug Prescribing'}]",,0.171444,"Using linear regression, an increase of 0.19 tablets prescribed (95% CI, 0.15-0.22) was found for each tablet increase in default quantity.","[{'ForeName': 'Juan Carlos C', 'Initials': 'JCC', 'LastName': 'Montoy', 'Affiliation': 'Department of Emergency Medicine, University of California, San Francisco.'}, {'ForeName': 'Zlatan', 'Initials': 'Z', 'LastName': 'Coralic', 'Affiliation': 'Department of Emergency Medicine, University of California, San Francisco.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Herring', 'Affiliation': 'Department of Emergency Medicine, Highland Hospital-Alameda Health System, Oakland, California.'}, {'ForeName': 'Eben J', 'Initials': 'EJ', 'LastName': 'Clattenburg', 'Affiliation': 'Department of Emergency Medicine, Highland Hospital-Alameda Health System, Oakland, California.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Raven', 'Affiliation': 'Department of Emergency Medicine, University of California, San Francisco.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.6544']
3424,31982095,The impact of rater training on the psychometric properties of standardized surgical skill assessment tools.,"INTRODUCTION
Competency-based frameworks are common in surgical training. However, the optimal use of standardized technical assessments is not well defined. We investigated the effect of rater training (RT) on the reliability and validity of four assessment tools.
MATERIALS AND METHODS
Forty-Seven surgeons were randomized to RT (N = 24) and no training (N = 23) groups. A task-specific checklist, pass-fail, visual analog, and OSATS global rating scale (GRS) were used to assess trainee knot-tying and suturing tasks. Delayed assessment was performed two weeks later. Internal consistency, intra/inter-rater reliability, and construct validity were measured.
RESULTS
The GRS had superior reliability and validity compared to the other tools regardless of training. No significant differences between training groups was found. However, the RT group trended to improved reliability for all tools at both assessments.
CONCLUSIONS
RT did not lead to significant improvements in skills assessments. Standardized assessments (OSATS GRS) are preferred due to their superior reliability and validity over other methods. Despite findings, we believe more effective training methods or repeated sessions may be required for sustained and significant effects.",2020,The GRS had superior reliability and validity compared to the other tools regardless of training.,['Forty-Seven surgeons'],"['rater training (RT', 'no training', 'rater training']","['skills assessments', 'Internal consistency, intra/inter-rater reliability, and construct validity', 'A task-specific checklist, pass-fail, visual analog, and OSATS global rating scale (GRS']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}]",47.0,0.0238416,The GRS had superior reliability and validity compared to the other tools regardless of training.,"[{'ForeName': 'Reagan L', 'Initials': 'RL', 'LastName': 'Robertson', 'Affiliation': 'Department of Surgery, University of Manitoba, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, University of Manitoba, Canada.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Gillman', 'Affiliation': 'Department of Surgery, University of Manitoba, Canada.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Vergis', 'Affiliation': 'Department of Surgery, University of Manitoba, Canada. Electronic address: avergis@sbgh.mb.ca.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.01.019']
3425,31120614,The LAPLAP study: a randomized placebo-controlled clinical trial assessing postoperative functional recovery using intraperitoneal local anaesthetic in laparoscopic colorectal surgery.,"AIM
Postoperative pain remains a major factor in recovery from colorectal resection. There is increasing interest in opioid-sparing analgesia, and intraperitoneal local anaesthetic (IPLA) has recently been shown to be useful in minor laparoscopic and open colorectal procedures. The aim of this study was to evaluate the impact of IPLA on functional recovery following major laparoscopic surgery. In this controlled trial, mobility, as measured by the De Morton Mobility Index (DEMMI), was used as a surrogate for postoperative functional recovery.
METHOD
Patients undergoing laparoscopic colorectal resection were randomized either to continuous ropivacaine (0.2% at 4-6 ml/h) or to saline (0.9%) which were administered via intraperitoneal catheter for 3 days postoperatively. Results were analysed in a double-blind manner. DEMMIs were assessed on postoperative days 1, 2, 3, 7 and 30, and data on pain, opioid consumption, gut and respiratory function, length of stay (LOS) and complications were recorded.
RESULTS
Ninety-six patients were recruited. There was no difference in primary outcome (i.e., functional recovery) between IPLA and placebo groups. Opioid consumption and LOS were similar between groups, and no differences were found for any secondary outcome measure. There were no adverse events related to ropivacaine.
CONCLUSION
Infusional intraperitoneal local anaesthetic appears to be safe but does not improve functional recovery or analgesic consumption following elective laparoscopic colorectal surgery, in the setting of an established enhanced recovery programme.",2019,"CONCLUSION
Infusional intraperitoneal local anaesthetic appears to be safe but does not improve functional recovery or analgesic consumption following elective laparoscopic colorectal surgery, in the setting of an established enhanced recovery programme.","['major laparoscopic surgery', 'Ninety-six patients were recruited', 'laparoscopic colorectal surgery', 'Patients undergoing laparoscopic colorectal resection']","['intraperitoneal local anaesthetic', 'continuous ropivacaine', 'placebo', 'IPLA']","['functional recovery or analgesic consumption', 'Opioid consumption and LOS', 'functional recovery', 'pain, opioid consumption, gut and respiratory function, length of stay (LOS) and complications']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2830173', 'cui_str': 'iPLA(2)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",96.0,0.611913,"CONCLUSION
Infusional intraperitoneal local anaesthetic appears to be safe but does not improve functional recovery or analgesic consumption following elective laparoscopic colorectal surgery, in the setting of an established enhanced recovery programme.","[{'ForeName': 'B D', 'Initials': 'BD', 'LastName': 'Stephensen', 'Affiliation': 'Department of Colorectal Surgery, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Clarke', 'Affiliation': 'Department of Colorectal Surgery, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'McManus', 'Affiliation': 'Department of Colorectal Surgery, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'Department of Colorectal Surgery, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Carroll', 'Affiliation': 'Department of Surgery, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Holz', 'Affiliation': 'Newcastle Anaesthetic and Perioperative Service, Newcastle, New South Wales, Australia.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Smith', 'Affiliation': 'University of Newcastle, Newcastle, New South Wales, Australia.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.14720']
3426,31957268,Effects of smartphone application education combined with hands-on practice in breast self-examination on junior nursing students in South Korea.,"BACKGROUND
Breast self-examination is a convenient and effective way to detect breast abnormalities. Based on Dale's Cone of Experience theory, we hypothesized that the combination of a smartphone application with hands-on practice would have a greater impact than using a smartphone application alone. The purpose of this study was to compare the effects of different educational methods on (a) knowledge, (b) attitudes, (c) skills, and (d) students' satisfaction with the learning methods.
METHODS
We conducted a pre- and post-test quasi-experimental design and developed a smartphone application using a video clip. One experimental group received smartphone-based education, another group received smartphone-based education combined with hands-on practice, and the control group received a one-time classroom lecture. We administered a pre-test, provided intervention, and conducted a post-test.
RESULTS
Among the three groups, the knowledge and attitude of the experimental groups were significantly higher than that of the control group. In addition, the group using the combination of the smartphone application and hands-on practice showed the highest score changes in skills and satisfaction with the learning methods.
CONCLUSIONS
Smartphone application use combined with hands-on practice could be an effective education method for breast self-examination.",2020,"Among the three groups, the knowledge and attitude of the experimental groups were significantly higher than that of the control group.",['junior nursing students in South Korea'],"['smartphone application education combined with hands', 'smartphone-based education, another group received smartphone-based education combined with hands-on practice, and the control group received a one-time classroom lecture']",['knowledge and attitude'],"[{'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0189596,"Among the three groups, the knowledge and attitude of the experimental groups were significantly higher than that of the control group.","[{'ForeName': 'So Ra', 'Initials': 'SR', 'LastName': 'Kang', 'Affiliation': 'Division of Nursing, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Hyewon', 'Initials': 'H', 'LastName': 'Shin', 'Affiliation': 'School of Nursing, Clemson University, Greenville, South Carolina, USA.'}, {'ForeName': 'JungMin', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, University of North Carolina at Greensboro, Greensboro, North Carolina, USA.'}, {'ForeName': 'Shin-Jeong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'School of Nursing, Hallym University, Chunchon, South Korea.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12318']